Sample records for olanzapine pilot study

  1. Effects of quetiapine and olanzapine in patients with psychosis and violent behavior: a pilot randomized, open-label, comparative study

    Gobbi G


    Full Text Available Gabriella Gobbi,1,2 Stefano Comai,1 Guy Debonnel1,2,† 1Neurobiological Psychiatric Unit, Department of Psychiatry, McGill University and McGill University Health Center, 2Institut Philippe Pinel, Department of Psychiatry, Université de Montréal, Montréal, QC, Canada †Guy Debonnel passed away on November 4, 2006 Objective: Patients suffering from psychosis are more likely than the general population to commit aggressive acts, but the therapeutics of aggressive behavior are still a matter of debate. Methods: This pilot randomized, open-label study compared the efficacy of quetiapine versus olanzapine in reducing impulsive and aggressive behaviors (primary endpoints and psychotic symptoms (secondary endpoints from baseline to days 1, 7, 14, 28, 42, 56, and 70, in 15 violent schizophrenic patients hospitalized in a maximum-security psychiatric hospital. Results: Quetiapine (525±45 mg and olanzapine (18.5±4.8 mg were both efficacious in reducing Impulsivity Rating Scale from baseline to day 70. In addition, both treatments reduced the Brief Psychiatric Rating Scale, Positive and Negative Syndrome Scale, and Clinical Global Impression Scale scores at day 70 compared to baseline, and no differences were observed between treatments. Moreover, quetiapine, but not olanzapine, yielded an improvement of depressive symptoms in the items “depression” in Brief Psychiatric Rating Scale and “blunted affect” in Positive and Negative Syndrome Scale. Modified Overt Aggression Scale scores were also decreased from baseline to the endpoint, but due to the limited number of patients, it was not possible to detect a significant difference. Conclusion: In this pilot study, quetiapine and olanzapine equally decreased impulsive and psychotic symptoms after 8 weeks of treatment. Double-blind, large studies are needed to confirm the validity of these two treatments in highly aggressive and violent schizophrenic patients. Keywords: schizophrenia, aggression

  2. Gabapentin adjunctive to risperidone or olanzapine in partially responsive schizophrenia: an open-label pilot study

    Adel Gabriel


    Full Text Available Adel GabrielDepartments of Psychiatry and Community Health Sciences, University of Calgary, Alberta, CanadaBackground: There is a great need in the treatment of schizophrenia for a drug, or drug ­combinations, to improve clinical response with fewer serious side effects. The objective of this study was to explore the therapeutic effects and tolerability of the anticonvulsant gabapentin as an adjunctive in the treatment of patients with partially responsive schizophrenia.Methods: Ten consenting patients with a confirmed Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision diagnosis of schizophrenia were identified. All patients failed at least one 12-week treatment trial with risperidone or olanzapine. Gabapentin was added to ongoing antipsychotic treatment with olanzapine or risperidone for eight weeks. The primary outcome measure was the Positive and Negative Syndrome Scale (PANSS. Other scales included the Calgary Depression Scale (CDSS and the Abnormal Involuntary Movement Scale (AIMS. Repeated-measures multivariate analysis of variance was utilized to examine changes in outcome measures over time with adjunctive treatment with gabapentin.Results: There was a significant drop in the PANSS and CDSS scores at endpoint (week 8. There were no significant differences between the two treatment groups with regard to changes in all outcome measures or in AIMS score. The adjunctive treatments were well tolerated and side effects were transient.Conclusion: Gabapentin could be used successfully as an adjunct to novel antipsychotics in partially responsive schizophrenia. However, large controlled studies are needed to examine the effectiveness of gabapentin in psychotic disorders.Keywords: schizophrenia, refractory, adjunctive treatment, gabapentin, risperidone, olanzapine

  3. Evaluation of striatal dopamine transporter density using ({sup 123}I)-{beta}-CIT SPECT in schizophrenic patients treated with olanzapine: pilot study

    Kim, Chul Eung; Moon, Hey Won; Choe, Won Sick; Kim, Chang Ho; Chi, Dae Yoon [Inha Univ., Incheon (Korea, Republic of)


    This pilot study was performed to understand the pharmacological effect of olanzapine, an atypical antipsychotic agent, on dopamine transporter in schizophrenic patients. Six patients (3 male, 3 female) with schizophrenia, who had not taken any psychotropic drugs for at least four weeks, were studied. Nuclear imaging using ({sup 123}I)-{beta}-CIT SPECT was obtained before and after 4-week treatment with olanzapine. Analysis of ROI on the striatum, caudate nucleus, and putamen was performed. Post-treatment uptake was significantly increased in all the ROIs compared with pre-treatment uptake. This preliminary study with the small number of schizophrenic patients suggested an increase in uptake of dopamine transporter in the striatum, caudate nucleus, and putamen after 4-week treatment with olanzapine, which warrants a large-scaled controlled study to confirm the current findings.

  4. Olanzapine

    Olanzapine is used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual ... help control your symptoms, but it will not cure your condition. It may take several weeks or ...

  5. A randomized controlled trial of the effect of sublingual orally disintegrating olanzapine versus oral olanzapine on body mass index: the PLATYPUS Study

    Karagianis, J.; Grossman, L.; Landry, J.; Reed, V. A.; de Haan, L.; Maguire, G. A.; Hoffmann, V. P.; Milev, R.


    BACKGROUND: Patients with schizophrenia and bipolar disorder have frequently reported weight gain during olanzapine treatment. Previous studies have observed a decrease in weight gain, or weight loss, in patients switching from standard olanzapine tablets (SOT) to orally disintegrating olanzapine

  6. Olanzapine plus dialectical behavior therapy for women with high irritability who meet criteria for borderline personality disorder: a double-blind, placebo-controlled pilot study.

    Linehan, Marsha M; McDavid, Joshua D; Brown, Milton Z; Sayrs, Jennifer H R; Gallop, Robert J


    This double-blind study examined whether olanzapine augments the efficacy of dialectical behavior therapy (DBT) in reducing anger and hostility in borderline personality disorder patients. Twenty-four women with borderline personality disorder (DSM-IV criteria) and high levels of irritability and anger received 6 months of DBT. Subjects were randomly assigned to receive either low-dose olanzapine or placebo and were assessed with standardized measures in a double-blind manner. The study was conducted from September 2000 to December 2002. Intent-to-treat analyses indicated that both treatment conditions resulted in significant improvement in irritability, aggression, depression, and self-inflicted injury (p borderline personality disorder. Effect sizes were moderate to large, with the small sample size likely limiting the ability to detect significant results. Overall, there were large and consistent reductions in irritability, aggression, depression, and self-injury for both groups of subjects receiving DBT.

  7. Metformin plus sibutramine for olanzapine-associated weight gain and metabolic dysfunction in schizophrenia: a 12-week double-blind, placebo-controlled pilot study.

    Baptista, Trino; Uzcátegui, Euderruh; Rangel, Nairy; El Fakih, Yamily; Galeazzi, Tatiana; Beaulieu, Serge; de Baptista, Enma Araujo


    Metformin (850-1700 mg) plus sibutramine (10-20 mg, n=13) or placebo (n=15) was administered for 12 weeks in olanzapine-treated chronic schizophrenia patients. Weight loss was similar in both groups: -2.8+/-3.2 kg vs. -1.4+/-2.6 kg. Except for preventing a triglyceride increase, the drug combination lacked efficacy for metabolic control in this clinical population.

  8. Pharmaceutical studies on and clinical application of olanzapine suppositories prepared as a hospital preparation

    Matsumoto, Kazuaki; Kimura, Satoru; Takahashi, Kenichi; Yokoyama, Yuta; Miyazawa, Masayuki; Kushibiki, Satoko; Katamachi, Morio; Kizu, Junko


    Background A new formulation of olanzapine available for terminally ill patients is needed. Rectal administration using suppositories is an alternative for patients for whom administration via the oral route is not feasible. In the present study, we prepared olanzapine suppositories, and confirmed using pharmaceutical tests. Furthermore, we demonstrated the efficacy and safety of olanzapine suppositories in terminally ill patients. Methods We prepared olanzapine suppositories using bases cons...


    Bithorai Basumatary


    Full Text Available BACKGROUND Psychotic disorders are a group of chronic debilitating psychiatric illness characterised by loss in touch with reality and disorders of thought, behaviour, appearance and speech. The second generation atypical antipsychotic olanzapine has been reported to be the commonly prescribed antipsychotic. However, olanzapine can cause adverse effects like weight gain, hyperglycaemia, diabetes, dyslipidaemia and metabolic syndrome. Quetiapine, another second generation antipsychotic has good efficacy and has become well established in the treatment of schizophrenia and manic episodes. There are reports on adverse effects of hyperglycaemia and diabetes with quetiapine, but these are comparatively lesser than olanzapine. The aim of the study is to compare the efficacy of olanzapine and quetiapine in patients with psychotic disorders. MATERIALS AND METHODS It was an unicentric, open label, prospective and comparative clinical study. Subjects (n=80 who were diagnosed with psychotic disorder were randomly assigned to receive olanzapine (group 1 or quetiapine (group 2. The efficacy of the two drugs was assessed on the basis Brief Psychiatric Rating Scale (BPRS scores at baseline, 1 week and 6 weeks. UKU scale (Udvalg Kliniske Undersogelser and laboratory investigations were used to assess the safety profile. RESULTS The two study groups had comparable sociodemographic profile. Both the groups showed significant reduction in psychotic symptoms as compared from baseline to 1 week and 6 weeks (p<0.001. The intergroup comparison of the efficacy of the two groups did not show any statistically significant results. There was statistically insignificant differences in the occurrence of adverse effects in both the groups. Sedation (50% in both the groups was the most common adverse effect in both the groups. The use of concomitant medications was comparable in both the groups. Benzodiazepines (56.3% in the olanzapine group and 51.9% in the quetiapine group

  10. Naturalistic study of olanzapine in treatment-resistaant ...

    Naturalistic study of olanzapine in treatment-resistaant schizophrenia and acute mania, depression and obsessional disorder. ... Whereas the Fiji government provides all aspects of mental health care services free of charge to its citizens, many schizophrenics have failed to respond to classical antipsychotic drugs.

  11. Olanzapine monotherapy and olanzapine combination therapy in the treatment of mania: 12-week results from the European Mania in Bipolar Longitudinal Evaluation of Medication (EMBLEM) observational study.

    Vieta, Eduard; Panicali, Francesco; Goetz, Iris; Reed, Catherine; Comes, Merce; Tohen, Mauricio


    To evaluate the 12-week outcomes (effectiveness, tolerability, and patterns of medication use) of olanzapine (either in antimanic monotherapy or in combination with other antipsychotics, anticonvulsants, and/or lithium) in patients with bipolar mania or mixed mania. EMBLEM (European Mania in Bipolar Longitudinal Evaluation of Medication) is a 24-month prospective observational study of in- and outpatients with acute mania/mixed mania conducted in 14 European countries. Primary outcome measures included Clinical Global Impressions-Bipolar Disorder scale (overall, mania, and depression); 5-item Hamilton Depression Rating Scale; and Young Mania Rating Scale. Tolerability measures included a questionnaire to assess patients' symptomatic complaints. Overall, 2004 patients received olanzapine (olanzapine monotherapy, n=673; olanzapine combination, n=1331). Concomitant therapy with antidepressants and/or anxiolytics was possible in both groups. The countries significantly differed in the use of olanzapine monotherapy versus olanzapine combination (pEMBLEM results suggest that in naturalistic settings, olanzapine (both as monotherapy and combination) may be effective in treating patients with bipolar mania. The use of olanzapine monotherapy or combination varies significantly across countries, but combination is generally the rule, rather than the exception.

  12. Theoretical study on the interaction of pregabalin and olanzapine with DNA



    Full Text Available This paper aims is to study the interaction of two drugs including pregabalin and olanzapine with DNA. For this purpose, density functional theory calculations and docking were used. The structure of pregabalin and olanzapine using B3Lyp theory level and the basis set 6-311 G(d,p was optimized. Highest occupied molecular orbital (HOMO and lowest unoccupied molecular orbital (LUMO calculated for each drugs. The obtained results showed that olanzapine is more reactive than pregabalin. Docking of drugs with DNA was performed and the results showed that binding affinity of olanzapine is higher than pregabalin. Also, the graphical results revealed that olanzapine interact with DNA via 5-terminal major groove of DNA, whereas pregabalin interact with DNA via 3- termind major groove.

  13. Memantine enhances the effect of olanzapine in patients with schizophrenia: A randomized, placebo-controlled study

    Ahmad Fakhri


    Full Text Available Glutamate dysregulation may be involved in the neuropathology of schizophrenia. Memantine, a drug approved by the FDA for the treatment of moderate to severe Alzheimer's disease, acts as a partial uncompetitive NMDA receptor antagonist. The aim of this study was to examine the efficacy of memantine as an adjunctive treatment to olanzapine in patients with schizophrenia. In this double-blind, placebo-controlled studies, patients with schizophrenia according to DSM-IV clinical criteria were selected. Patients were randomly assigned to receive either memantine (week 1:10 mg/day; weeks 2-6:20 mg/day plus olanzapine (15-20 mg/day or olanzapine plus placebo. At baseline, no statistically significant difference regarding the mean total PANSS scores between treatment groups was found. Results showed that memantine significantly improved the positive and negative PANSS score in patients maintained on olanzapine after six weeks compared to olanzapine alone (P<0.001. Furthermore, female patients showed significantly better response than males, especially in positive PANSS score. No significant changes in extrapyramidal symptoms were observed.These findings indicate that olanzapine efficacy might be augmented with memantine. Furthermore, this effect is more remarkable in female patients with schizophrenia.

  14. A comparative study of olanzapine versus asenapine in acute treatment of manic episode: A 3-week prospective study

    Ajeet Sidana


    Full Text Available Introduction: Treatment of bipolar disorders has evolved over the years from conventional mood stabilizers to second-generation antipsychotics. Among the atypical antipsychotics, few have been approved by Food and Drug Administration as treatment of bipolar disorders. Aim: To study the efficacy and tolerability of olanzapine and asenapine in the acute treatment of bipolar disorder-manic episode in a 3-week randomized prospective study. Materials and Methods: A 3-week randomized, prospective, comparative, flexible doses of olanzapine (5-30 mg/day and asenapine (10-20 mg/day for acute treatment of bipolar disorder-current manic episode with or without psychotic symptoms in hospitalized patients. Results: The end-point reduction in mean score of Young Mania rating scale in the olanzapine group was 15.82 in comparison to 6.88 in the asenapine group. Mean score on clinical global impression for bipolar disorder and positive and negative syndrome scale was significantly less in the olanzapine group at the end of the study. 81.81% patients in olanzapine group and 17.60% patients in asenapine group had clinical response. There was significant average weight gain in the olanzapine group - 1.9 kg in comparison to 0.87 kg in asenapine group. Conclusion: The clinical response with olanzapine is significantly higher than the asenapine in the treatment of bipolar disorder-manic episode with or without psychotic symptoms. However, there is significant weight gain in olanzapine-treated patients.

  15. Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting: A Comparative Study From Sudan

    Alaa A.M. Osman


    Full Text Available Purpose: Chemotherapy-induced nausea and vomiting (CINV is a distressing adverse effect. Neurokinin-1 receptor antagonist (NK1RA–containing regimens are the standard regimens for CINV prophylaxis in patients with cancer receiving highly or moderately emetogenic chemotherapy (HEC or MEC. NK1RA agents are expensive and were not registered in Sudan. Recently, regimens containing olanzapine, the available and affordable medication in Sudan, were introduced as another option. This study aimed to compare the efficacy of an olanzapine-containing regimen with the antiemetic regimen that was currently used in our institute for CINV prophylaxis in HEC/MEC settings. Patients and Methods: The study prospectively compared an olanzapine-containing regimen (acute phase: olanzapine, ondansetron, dexamethasone; delayed phase: olanzapine, ondansetron with an ondansetron/dexamethasone regimen (acute phase: ondansetron, dexamethasone; delayed phase: ondansetron in adult patients with cancer receiving HEC or MEC. The study outcomes were complete response (CR; no emesis and no rescue medications and nausea control (no nausea, which were assessed in the acute (0 to 24 hours, delayed (24 to 120 hours, and overall (0 to 120 hours phases. Results: The study included 131 patients (olanzapine-containing: 50 patients; ondansetron/dexamethasone: 81 patients. CR and nausea control were higher in the olanzapine-containing than in the ondansetron/dexamethasone regimen (CR: acute phase, 86% v 71.6%; P = .086; delayed phase, 72% v 30.9%; P < .001; overall phase, 66% v 25.9%; P < .001; nausea control: acute phase, 86% v 74.1%; P = .127; delayed phase, 76% v 34.6%; P < .001; overall phase, 72% v 29.6%; P < .001. The major toxicity of olanzapine was grade 1 and 2 sedation or drowsiness (25 patients. Conclusion: An olanzapine-containing regimen has better efficacy for prevention of CINV in the HEC/MEC setting. Oncologists working in a limited-resource setting should be familiar

  16. Naturalistic study of olanzapine in treatment-resistaant ...

    Background: Whereas the Fiji government provides all aspects of mental health care services free of charge to its citizens, many schizophrenics have failed to respond to classical antipsychotic drugs. Objective: To assess the efficacy and safety of olanzapine among various patients with severe psychiatric disorders.

  17. Translation of randomised controlled trial findings into clinical practice: comparison of olanzapine and valproate in the EMBLEM study.

    Novick, D; Gonzalez-Pinto, A; Haro, J M; Bertsch, J; Reed, C; Perrin, E; Tohen, M


    The aim of this study was to compare the outcomes of olanzapine- and valproate-treated patients in an observational study of acute mania with the results of a randomised controlled trial (RCT) assessing the same treatments. EMBLEM (European Mania in Bipolar Evaluation of Medication) was a 2-year, prospective, observational study of health outcomes associated with the treatment of mania. Severity of mania and depression were assessed at baseline and 6 weeks using the YMRS and the 5-item version of the HAMD, respectively. 621 patients were analysed (n=107 valproate, n=514 olanzapine). Both groups improved from baseline to 6 weeks in mean YMRS and HAMD-5 total scores, with greater mean improvements in the olanzapine compared with the valproate group. Olanzapine was associated with more weight gain and less gastrointestinal difficulties than valproate. The EMBLEM results support those of the RCT, which suggest that olanzapine monotherapy seems to be more effective than valproate monotherapy in the treatment of acute mania.

  18. Safety and effectiveness of olanzapine in monotherapy: a multivariate analysis of a naturalistic study.

    Ciudad, Antonio; Gutiérrez, Miguel; Cañas, Fernando; Gibert, Juan; Gascón, Josep; Carrasco, José-Luis; Bobes, Julio; Gómez, Juan-Carlos; Alvarez, Enrique


    This study investigated safety and effectiveness of olanzapine in monotherapy compared with conventional antipsychotics in treatment of acute inpatients with schizophrenia. This was a prospective, comparative, nonrandomized, open-label, multisite, observational study of Spanish inpatients with an acute episode of schizophrenia. Data included safety assessments with an extrapyramidal symptoms (EPS) questionnaire and the report of spontaneous adverse events, plus clinical assessments with the Brief Psychiatric Rating Scale (BPRS) and the Clinical Global Impressions-Severity of Illness (CGI-S). A multivariate methodology was used to more adequately determine which factors can influence safety and effectiveness of olanzapine in monotherapy. 339 patients treated with olanzapine in monotherapy (OGm) and 385 patients treated with conventional antipsychotics (CG) were included in the analysis. Treatment-emergent EPS were significantly higher in the CG (pOGm (p=0.005). Logistic regression analyses revealed that the only variable significantly correlated with treatment-emergent EPS and clinical response was treatment strategy, with patients in OGm having 1.5 times the probability of obtaining a clinical response and patients in CG having 5 times the risk of developing EPS. In this naturalistic study olanzapine in monotherapy was better-tolerated and at least as effective as conventional antipsychotics.

  19. A randomized, placebo-controlled study of zonisamide to prevent olanzapine-associated weight gain.

    McElroy, Susan L; Winstanley, Erin; Mori, Nicole; Martens, Brian; McCoy, Jessica; Moeller, Dianna; Guerdjikova, Anna I; Keck, Paul E


    Weight gain is commonly observed with olanzapine treatment. Zonisamide is an antiepileptic drug associated with weight loss. This study examined the effectiveness of zonisamide in preventing weight gain in 42 patients beginning olanzapine for bipolar disorder or schizophrenia. Each patient had a body mass index of 22 mg/kg or greater and was randomized to taking olanzapine with either zonisamide (n = 20) or placebo (n = 22) for 16 weeks. The primary outcome measure was change in body weight in kilograms from baseline. In the primary analysis using longitudinal regression, patients who received zonisamide had a significantly slower rate of weight gain and increase in body mass index than those who received placebo. The patients treated with zonisamide gained a mean (SD) of 0.9 (3.3) kg, whereas those treated with placebo gained a mean (SD) of 5.0 (5.5) kg; P = 0.01. None of the patients in the zonisamide group, compared with 7 patients (33%) in the placebo group, gained 7% of body weight or greater from baseline (Fisher exact test, P = 0.009). The zonisamide group, however, reported significantly more cognitive impairment as an adverse event than the placebo group (25% vs 0, respectively; P = 0.02). Zonisamide was effective for mitigating weight gain in patients with bipolar disorder or schizophrenia initiating treatment with olanzapine but was associated with cognitive impairment as an adverse event.

  20. Double-blind, placebo-controlled study of dialectical behavior therapy plus olanzapine for borderline personality disorder.

    Soler, Joaquim; Pascual, Juan Carlos; Campins, Josefa; Barrachina, Judith; Puigdemont, Dolors; Alvarez, Enrique; Pérez, Victor


    The aim of this study was to determine the efficacy and safety of dialectical behavior therapy plus olanzapine compared with dialectical behavior therapy plus placebo in patients with borderline personality disorder. Sixty patients with borderline personality disorder were included in a 12-week, double-blind, placebo-controlled study. All patients received dialectical behavior therapy and were randomly assigned to receive either olanzapine or placebo following a 1-month baseline period. Seventy percent of the patients completed the 4-month trial. Combined treatment showed an overall improvement in most symptoms studied in both groups. Olanzapine was associated with a statistically significant improvement over placebo in depression, anxiety, and impulsivity/aggressive behavior. The mean dose of olanzapine was 8.83 mg/day. A combined psychotherapeutic plus pharmacological approach appears to lower dropout rates and constitutes an effective treatment for borderline personality disorder.

  1. Translation of randomised controlled trial findings into clinical practice: comparison of olanzapine and valproate in the EMBLEM study

    Novick, D; Gonzalez-Pinto, A; Haro, J M


    OBJECTIVES: The aim of this study was to compare the outcomes of olanzapine- and valproate-treated patients in an observational study of acute mania with the results of a randomised controlled trial (RCT) assessing the same treatments. METHODS: EMBLEM (European Mania in Bipolar Evaluation......: The EMBLEM results support those of the RCT, which suggest that olanzapine monotherapy seems to be more effective than valproate monotherapy in the treatment of acute mania....

  2. Assessment of strategies for switching patients from olanzapine to risperidone: A randomized, open-label, rater-blinded study

    Berry Sally A


    Full Text Available Abstract Background In clinical practice, physicians often need to change the antipsychotic medications they give to patients because of an inadequate response or the presence of unacceptable or unsafe side effects. However, there is a lack of consensus in the field as to the optimal switching strategy for antipsychotics, especially with regards to the speed at which the dose of the previous antipsychotic should be reduced. This paper assesses the short-term results of strategies for the discontinuation of olanzapine when initiating risperidone. Methods In a 6-week, randomized, open-label, rater-blinded study, patients with schizophrenia or schizoaffective disorder, on a stable drug dose for more than 30 days at entry, who were intolerant of or exhibiting a suboptimal symptom response to more than 30 days of olanzapine treatment, were randomly assigned to the following switch strategies (common risperidone initiation scheme; varying olanzapine discontinuation: (i abrupt strategy, where olanzapine was discontinued at risperidone initiation; (ii gradual 1 strategy, where olanzapine was given at 50% entry dose for 1 week after risperidone initiation and then discontinued; or (iii gradual 2 strategy, where olanzapine was given at 100% entry dose for 1 week, then at 50% in the second week, and then discontinued. Results The study enrolled 123 patients on stable doses of olanzapine. Their mean age was 40.3 years and mean (± standard deviation (SD baseline Positive and Negative Syndrome Scale (PANSS total score of 75.6 ± 11.5. All-cause treatment discontinuation was lowest (12% in the group with the slowest olanzapine dose reduction (gradual 2 and occurred at half the discontinuation rate in the other two groups (25% in abrupt and 28% in gradual 1. The relative risk of early discontinuation was 0.77 (confidence interval 0.61–0.99 for the slowest dose reduction compared with the other two strategies. After the medication was changed, improvements at

  3. Effectiveness of olanzapine monotherapy and olanzapine combination treatment in the long term following acute mania--results of a two year observational study in bipolar disorder (EMBLEM).

    Gonzalez-Pinto, Ana; Vieta, Eduard; Reed, Catherine; Novick, Diego; Barraco, Alessandra; Aguado, Jaume; Haro, Josep Maria


    This study compared the 2-year outcomes of patients with a manic/mixed episode of bipolar disorder taking olanzapine monotherapy or olanzapine in combination with other agents. EMBLEM (European Mania in Bipolar Longitudinal Evaluation of Medication) is a 2-year, prospective, observational study of clinical and functional outcomes of bipolar patients with an index manic/mixed episode. The study consisted of two phases: acute (12 weeks) and maintenance (follow-up over 2 years). The longitudinal outcome measure was the Clinical Global Impression-Bipolar Disorder scale. Cox regression models compared outcomes of both therapy groups using intention-to-treat and switching medication analysis. Treatment-emergent adverse events were also assessed. 1076 patients were included in this analysis. 29% took olanzapine as monotherapy (n = 313) and 71% as combination (n = 763) at 12-weeks post-baseline (end of study acute phase). After adjusting for patient characteristics using switching medication analysis, only relapse rates differed (p = 0.01) in favour of monotherapy-treated patients. There was no significant difference in rates of improvement, remission, and recovery. Patients treated with combination therapy reported more tremor (OR 2.37, 95%CI 1.44-3.89) and polyuria (OR 3.08, 95%CI 1.45-6.54) treatment-emergent events than monotherapy, although weight change was greater in the monotherapy group. Unknown confounding and potential selection bias may differentially impact treatment outcomes. EMBLEM patients benefitted from the selected therapy to a similar extent. Differences in patient characteristics between those prescribed monotherapy and combination therapy appear to be clinically relevant in the treatment decision. Physicians must balance the benefits and risks when determining appropriate treatment for individual patients. Copyright © 2010 Elsevier B.V. All rights reserved.

  4. Comparison of olanzapine and risperidone in the EMBLEM Study: translation of randomized controlled trial findings into clinical practice.

    Novick, Diego; Reed, Catherine; Haro, Josep Maria; Gonzalez-Pinto, Ana; Perrin, Elena; Aguado, Jaume; Tohen, Mauricio


    Data from the EMBLEM Study, a 2-year, prospective, observational study of health outcomes associated with acute treatment of patients experiencing a manic/mixed episode of bipolar disorder, was used to compare the effectiveness of olanzapine monotherapy versus risperidone monotherapy, and to investigate whether the treatment effects were similar to those reported in a 3-week, randomized controlled trial assessing the same treatments. Symptom severity measures included the Young Mania Rating Scale (YMRS), the 5-item Hamilton Depression Rating Scale, and the Clinical Global Impression-Bipolar Disorder Scale. A total of 245 EMBLEM inpatients were analyzed with YMRS >or=20: olanzapine (n=209), risperidone (n=36). Both the treatment groups had similar improvements in YMRS from baseline to 6 weeks, but there was a significantly greater improvement in 5-item Hamilton Depression Rating Scale in the olanzapine group. There was a similar improvement in Clinical Global Impression-Bipolar Disorder Scale in both the groups and the occurrence of treatment-emergent adverse events and weight gain did not differ between the treatment groups. The EMBLEM results partly support those of the randomized controlled trial, which suggests olanzapine and risperidone have similar improvements in mania but that olanzapine monotherapy may be more effective than risperidone monotherapy in the treatment of depressive symptoms associated with mania. Limitations include differences in study design, patient population, and length of follow-up.

  5. Intramuscular Olanzapine in the Management of Behavioral and Psychological Symptoms in Hospitalized Older Adults: A Retrospective Descriptive Study

    Silvia Duong


    Full Text Available Background. While behavioral and psychological symptoms are frequent in hospitalized older adults with dementia or delirium, data supporting the off-label use of intramuscular atypical antipsychotics remain scarce. We examined the use of short-acting intramuscular (IM olanzapine in hospitalized older adults to manage behavioral and psychological symptoms. Methods. A retrospective observational study of inpatients 65 years or older with at least one order for olanzapine IM during admission in urban Ontario Canada was conducted. Patient demographics, prescriptions for olanzapine IM, reason for administration, perceived effectiveness, adverse events, concurrently prescribed psychotropics, comorbidities, and patient discharge destination were recorded. Results. Among 82 patients aged 65–96 years (mean ± SD 79.3 ± 7.7 85 cases were identified. Cognitive impairment or dementia affected 63.5% and 50.6% had comorbidities. Olanzapine IM was ordered 102 times and 34 patients (41% received at least one dose. The intended efficacy was achieved in 79.4% of 78 cases of 124 doses given (62.9%. Fourteen (41% patients who received doses experienced adverse events, with sedation and hypotension being the most common. Conclusions. Olanzapine IM appears effective in hospitalized older adults but is associated with potential adverse events. Structured monitoring and documentation are needed to ensure safe use in this high-risk population.

  6. Risperidone, quetiapine, and olanzapine adjunctive treatments in major depression with psychotic features: a comparative study

    Gabriel A


    Full Text Available A Gabriel Departments of Psychiatry and Community Health Sciences, University of Calgary, Calgary, AB, Canada Objectives: The purpose of this study was to compare the effectiveness of novel antipsychotics in the treatment of psychotic depression. Method: Consecutive patients who were admitted (n = 51 with a confirmed diagnosis of major depression with psychotic features (delusions or hallucinations or both participated in this open-label, naturalistic study. All patients were treated with selective serotonin reuptake inhibitors (SSRIs and serotonin–norepinephrine reuptake inhibitors (SNRIs (citalopram or venlafaxine extended release [XR], and atypical antipsychotic agents were added, as tolerated, during the first week of initiating the citalopram or venlafaxine. There were patients (n = 16 who received risperidone, who received quetiapine (n = 20, and who received olanzapine (n = 15, as an adjunctive treatment to either citalopram or venlafaxine for at least 8 weeks. Outcome measures included the Clinical Global Impression-Severity subscale (CGI-S, as the primary outcome measure, as well as the Hamilton Rating Scale for Depression-21 item (HAM-D21 and the Brief Psychiatric Rating Scale (BPRS. Tolerance to treatments and weight changes were monitored over the period of the trial. Results: All patients completed the trial with no drop outs. At 8 weeks, there was a statistically significant (P 0.01 in the olanzapine group. Conclusion: Quetiapine, risperidone, and olanzapine, given as adjunctive treatment with SSRIS or SNRIs can significantly and equally improve depressive and psychotic symptoms, in the short-term treatment of major depression with psychotic features. The author recommends that large controlled trials be conducted to examine the differences in long-term efficacy and tolerance between the atypical antipsychotic agents, in the treatment of major depression with or without psychotic features. Keywords: depression, novels

  7. Predictors of antipsychotic monotherapy with olanzapine during a 1-year naturalistic study of schizophrenia patients in Japan

    Ye W


    Full Text Available Wenyu Ye1, Haya Ascher-Svanum2, Jennifer A Flynn3, Yuka Tanji3, Michihiro Takahashi3,41Lilly Suzhou Pharmaceutical Co, Shanghai, People's Republic of China; 2Eli Lilly and Company, Indianapolis, IN, USA; 3Lilly Research Laboratories Japan, Eli Lilly Japan K.K., Kobe, 4Terauchi-Takahashi Psychiatric Clinic, Ashiya, JapanPurpose: Although expert guidelines for the treatment of schizophrenia recommend antipsychotic monotherapy, the use of antipsychotic polypharmacy is common. This study identified characteristics that differentiate patients with schizophrenia who are treated with olanzapine monotherapy versus polypharmacy in usual care in Japan.Patients and methods: In a large (N = 1850 prospective, observational study, Japanese patients with schizophrenia who initiated treatment with olanzapine were followed for 1 year. Consistent with past research, antipsychotic polypharmacy was defined as the concurrent use of olanzapine and another antipsychotic for at least 60 days. Switching was defined as discontinuing a prior antipsychotic therapy rather than augmenting the medication regimen. Predictors of antipsychotic monotherapy were based on information available at the time of olanzapine initiation. Baseline characteristics were compared using t-tests and Χ2 tests. Stepwise logistic regression was used to identify independent predictors of monotherapy.Results: Patients treated with olanzapine monotherapy (43.2% differed from those treated with antipsychotic polypharmacy (56.8% on demographics, treatment history, baseline symptom levels, functional levels, and treatment-emergent adverse events. Stepwise logistic regression identified multiple variables that significantly predicted monotherapy: older age, shorter duration of schizophrenia, outpatient status, comorbid medical conditions, lower body mass index, no prior anticholinergic use, no prior mood stabilizer use, and switching from a previous antipsychotic (typical or atypical

  8. Attenuating effect of reboxetine on appetite and weight gain in olanzapine-treated schizophrenia patients: a double-blind placebo-controlled study.

    Poyurovsky, Michael; Fuchs, Camil; Pashinian, Artashez; Levi, Aya; Faragian, Sarit; Maayan, Rachel; Gil-Ad, Irit


    Search for safe and effective strategies to diminish weight gain associated with second generation antipsychotics (SGAs) is imperative. In the present study, we sought to replicate our preliminary findings, which indicated that coadministration of the selective norepinephrine reuptake inhibitor reboxetine attenuates olanzapine-induced weight gain. Fifty-nine patients hospitalized for first-episode DSM-IV schizophrenic disorder participated in this randomized double-blind study. Reboxetine (4 mg/day; 31 patients) or placebo (29 patients) was coadministered with olanzapine (10 mg/day) for 6 weeks. Analysis was by intention-to-treat. Nine patients in each group prematurely discontinued the trial. Olanzapine/reboxetine-treated patients showed a significantly lower increase in body weight (mean = 3.31 kg, SD = 2.73) than their olanzapine/placebo-treated counterparts (mean = 4.91 kg, SD = 2.45). Significantly fewer olanzapine/reboxetine-treated patients gained at least 7% of their initial weight, the cutoff for clinically significant weight gain (6 [19.4%] of 31 patients vs 13 [46.4%] of 28 patients). Seven (22.6%) olanzapine/reboxetine-treated patients compared to only one patient (3.6%) in the olanzapine/placebo group revealed no weight change or even modest weight loss. Appetite increase was significantly lower in the olanzapine/reboxetine than olanzapine/placebo group and was correlated with attenuation of weight gain. Reboxetine addition was safe and well tolerated. The results confirm that coadministration of reboxetine promotes a clinically meaningful attenuation of olanzapine-induced weight gain in schizophrenia patients. If substantiated in long-term studies, along with behavioral management and diet counseling, reboxetine may have a clinical utility in controlling SGA-induced weight gain.

  9. Translation of randomised controlled trial findings into clinical practice: comparison of olanzapine and valproate in the EMBLEM study

    Novick, D; Gonzalez-Pinto, A; Haro, J M


    OBJECTIVES: The aim of this study was to compare the outcomes of olanzapine- and valproate-treated patients in an observational study of acute mania with the results of a randomised controlled trial (RCT) assessing the same treatments. METHODS: EMBLEM (European Mania in Bipolar Evaluation of Medi...

  10. A Flexible-Dose Study of Paliperidone ER in Patients With Nonacute Schizophrenia Previously Treated Unsuccessfully With Oral Olanzapine.

    Kotler, Moshe; Dilbaz, Nesrin; Rosa, Fernanda; Paterakis, Periklis; Milanova, Vihra; Smulevich, Anatoly B; Lahaye, Marjolein; Schreiner, Andreas


    The goal of this study was to explore the tolerability, safety, and treatment response of switching from oral olanzapine to paliperidone extended release (ER). Adult patients with nonacute schizophrenia who had been treated unsuccessfully with oral olanzapine were switched to flexible doses of paliperidone ER (3 to 12 mg/d). The primary efficacy outcome was a ≥ 20% improvement in Positive and Negative Syndrome Scale (PANSS) total scores from baseline to endpoint for patients who switched medications because of lack of efficacy with olanzapine and noninferiority versus previous olanzapine treatment (mean endpoint change in PANSS total scores vs. baseline of ≤ 5 points) for patients who switched for reasons other than lack of efficacy. Safety and tolerability were assessed by monitoring adverse events, extrapyramidal symptoms, and weight change. Of 396 patients, 65.2% were men, mean age was 40.0 ± 12.0 years, and 75.5% had paranoid schizophrenia. Among the patients whose main reason for switching was lack of efficacy, an improvement in the PANSS total score of ≥ 20% occurred in 57.4% of patients. Noninferiority was confirmed for each subgroup of patients whose main reason for switching was something other than lack of efficacy. Paliperidone ER was generally well tolerated. Extrapyramidal symptoms as measured by total Extrapyramidal Symptom Rating Scale scores showed statistically significant and clinically relevant improvements at endpoint, the average weight decreased by 0.8 ± 5.2 kg at endpoint, and a clinically relevant weight gain of ≥ 7% occurred in 8.0% of patients. Paliperidone ER flexibly-dosed over 6 months was well tolerated and associated with a meaningful clinical response in patients with nonacute schizophrenia who had previously been unsuccessfully treated with oral olanzapine.

  11. Pilot study

    Hofmeester, G.H.; Swart, A.; Dijk, E. van


    In May 1980 it was decided to organize an intercomparison of personal dosimeters for photon radiations. The Commission of the European Communities initiated the intercomparison by starting a pilot study in which three laboratories NPL (United Kingdom), PTB (Germany) and RIV (The Netherlands) were asked to irradiate a series of personal dosemeters from institutes, GSF (Muenchen), CEA (Fontenay-aux-Roses), CNEN (Bologna) and CEGB (Berkeley). The latter institutes are secondary standard laboratories and have a radiation protection service as well. A new aspect of this pilot study is the fact that the irradiations also take place in front of a phantom. Irradiations took place in July and August 1980. The results of 4 institutes show that the personal dosemeters are quite capable of measuring the backscattered photon components

  12. A Comparative Study between Olanzapine and Risperidone in the Management of Schizophrenia

    Saeed Shoja Shafti


    Full Text Available Introduction. Since a variety of comparisons between risperidone and olanzapine have resulted in diverse outcomes, so safety and efficacy of them were compared again in a new trial. Method. Sixty female schizophrenic patients entered into one of the assigned groups for random allocation to olanzapine or risperidone (n=30 in each group in a double-blind, 12-week clinical trial. Scale for Assessment of Positive Symptoms (SAPS and Scale for Assessment of Negative Symptoms (SANS were used as the primary outcome measures. Clinical Global Impressions-Severity Scale (CGI-S, Schedule for Assessment of Insight (SAI, and finally Simpson Angus Scale (SAS as well were employed as secondary scales. Results. While both of olanzapine and risperidone were significantly effective for improvement of positive symptoms (P<0.0001, as regards negative symptoms, it was so only by means of olanzapine (P<0.0003. CGI-S and SAI, as well, were significantly improved in both of the groups. SAS increment was significant only in the risperidone group (P<0.02. Conclusion. While both of olanzapine and risperidone were equally effective for improvement of positive symptoms and insight, olanzapine showed superior efficacy with respect to negative symptoms, along with lesser extrapyramidal side effects, in comparison with risperidone.

  13. A Study to Assess the Therapeutic Effect of Enalapril on Olanzapine Induced Metabolic Syndrome in Wistar Rats.

    Arivazhahan, Avinash; Bairy, Laxminarayana Kurady; Nayak, Veena; Kunder, Sushil Kiran


    Metabolic Syndrome (MS) is a complex of risk factors for the development of cardiovascular complications and Type 2 Diabetes Mellitus (DM). Pharmacological management of the condition is complex, as multiple drug groups have to be used, as the syndrome itself is multi faceted. Angiotensin Converting Enzyme Inhibitors (ACEIs) are chiefly used to manage the hypertensive component of the syndrome. However, recent studies have shown that these drugs may have a role in the non hypertensive aspects of the syndrome as well. To evaluate the therapeutic effect of enalapril on total body weight, random blood glucose and serum lipid profile in a rodent model of olanzapine induced MS. Three different dosages (1 mg/kg/day, 10 mg/kg/day and 20 mg/kg/day) of oral enalapril were administered (for three weeks) in albino wistar rats, which received prior intra peritoneal olanzapine (for three weeks), and compared against control (normal saline) and standard (olanzapine only and enalapril only) groups. Parameters like total body weight, random blood glucose and serum lipid profile were measured at baseline, at three weeks and at six weeks. Enalapril at 20 mg/kg/day was found to be effective in reversing the weight gain, hyperglycaemia and hypercholesterolaemia, without any changes in triglycerides, High Density Lipoprotein (HDL) and Low Density Lipoprotein (LDL). 10 mg/kg/day of enalapril prevented any further rise in body weight, blood glucose, total cholesterol and serum triglycerides, after olanzapine was stopped. 1 mg/kg/day of enalapril was ineffective. High dose of enalapril may be considered as a component of therapeutic regimens to combat weight gain, hyperglycaemia and dyslipidaemia seen in MS, in addition to its antihypertensive utility. Further rodent and clinical studies may be required to ascertain the same.

  14. The Study of the Effectiveness of Olanzapine as a Maintenance Treatment in Opioid Dependents, a Randomized Clinical Trial

    Azarekhsh Mokri


    Full Text Available Introduction: In this research, researchers want to study the effectiveness of Olanzapine on reduction of substance abuse relapse among people who are dependent to opioid material, merely. Method: A randomized clinical trial was designed. The population was opioid dependence subjects (only men that were diagnosed based on DSM-IV TR criteria, and referred to national center of addiction studies clinic. Detoxification was done by using of Clonidine, Clonazepam, Disiklomin, and NSAIDS within7 through 10 days. In second stage, the Patients who were referred to the clinic those men who had satisfied criterions selected. Demographic forms, testimonial certificate, Addiction Severity Index, Beck Depression Questionnaire, Zung Self report anxiety test administered among selected sample. Sample divided to two groups (placebo and Olanzapine the research last for 8 weeks. Results: the results showed that addiction severity reduced in both groups, but there was not significant difference in reduction of addiction severity between two groups. There was significant difference in depression and anxiety among mean scores of base line and follow up in both groups but there was not significant difference between two groups in follow up measures. Conclusion: Altogether, the results did not confirm the effectiveness of Olanzapine on maintenance treatment of opioid dependence.

  15. Safety and effectiveness of rapid-acting intramuscular olanzapine for agitation associated with schizophrenia – Japan postmarketing surveillance study

    Katagiri H


    Full Text Available Hideaki Katagiri,1 Masanori Taketsuna,2 Shinpei Kondo,3 Kenta Kajimoto,4 Etsuko Aoi,5 Yuka Tanji1 1Bio Medicine, 2Statistical Sciences, 3Post Marketing Study Management, 4Scientific Communications, Medicines Development Unit Japan, 5Global Patient Safety Japan, Quality and Patient Safety, Eli Lilly Japan K.K., Kobe, Japan Objective: The objective of this study was to evaluate the safety and effectiveness of rapid-acting intramuscular (IM olanzapine in the treatment of acute agitation associated with schizophrenia in real-world clinical settings in Japan.Methods: In this multicenter, postmarketing surveillance (PMS study, patients with acute agitation associated with schizophrenia were treated with IM olanzapine daily in a daily clinical setting. The observational period ranged from 1 to 7 days, including the day of initial administration. Safety was assessed by reporting treatment-emergent adverse events (TEAEs and adverse drug reactions (ADRs. The Positive and Negative Syndrome Scale – Excited Component (PANSS-EC score was used to evaluate effectiveness at baseline and at 2 hours (after each administration, 2 days, and 3 days (end of the observational period from the last administration of the IM olanzapine injection.Results: The safety analysis set included 999 patients, and the initial dose of 10 mg was administered to 955 patients. TEAEs were reported in 28 patients (36 events, the most common of which were dyslalia (5 patients, akathisia and somno­lence (4 patients each, hepatic function abnormal (3 patients, and constipation and dehydration (2 patients each. One serious adverse event of akathisia occurred during the observation period. The PANSS-EC score (mean ± standard deviation was 23.3±6.4 (n=625 at baseline, 16.9±7.0 (n=522 at 2 hours after initial injection, and 14.9±6.5 (n=650 at the last observation carried forward.Conclusion: The results of this Japanese PMS study demonstrated that IM olanzapine is safe and has a

  16. Frequency of Extrapyramidal Adverse Reactions in Schizophrenic Outpatients Treated with Risperidone, Olanzapine, Quetiapine or Haloperidol : Results of the EIRE Study.

    Bobes, Julio; Rejas, J; Garcia-Garcia, M; Rico-Villademoros, F; García-Portilla, M P; Madrigal, M; Hernández, G


    The EIRE (Estudio de Investigaciön de Resultados en Esquizofrenia - Outcomes Research Study in Schizophrenia) study was initiated in order to assess the frequency of adverse reactions [extrapyramidal symptoms (EPS), hyperprolactinaemia, sexual dysfunction and weight gain] caused by atypical antipsychotics and haloperidol in patients with schizophrenia during routine treatment in clinical practice. This paper presents the results of the assessment of extrapyramidal adverse reactions. Outpatients diagnosed with schizophrenia according to the Diagnostic and Statistical Manual of mental disorders, 4th edition (DSM-IV), criteria and receiving a single antipsychotic (risperidone, olanzapine, quetiapine or haloperidol) for at least 4 weeks were consecutively recruited. In this cross-sectional and non-interventional study data were collected in a single visit; this included demographic and clinical characteristics, current antipsychotic and concomitant treatment, and data on several adverse effects listed in a modified version of the UKU (Udvalg for Kliniske Undersogelser - Committee on Clinical Investigations) scale. For paired comparisons of the frequency of adverse reactions between treatments the Chi-squared (χ 2 ) test was used. For estimation of the risk of a given adverse reaction with a given treatment a logistic regression method was used. 636 evaluable patients (of 669 recruited) were assessed. The frequency of EPS with haloperidol (78.3% of the cases) was higher than with risperidone (55.1%), quetiapine (39.5%) and olanzapine (35.8%) [χ 2 : p < 0.05], and the difference between risperidone and olanzapine was also statistically significant (χ 2 : p < 0.05). Very similar results were obtained in the individualised analysis of the items as regards the occurrence of akathisia, which was also more frequent in the haloperidol (36.8%) and risperidone (19.7%) groups than in the olanzapine (11.4%) and quetiapine (2.6%) groups (χ 2 : p < 0.05). Olanzapine, quetiapine

  17. A double blind, placebo-controlled, randomized crossover study of the acute metabolic effects of olanzapine in healthy volunteers.

    Vance L Albaugh

    Full Text Available Atypical antipsychotics exhibit metabolic side effects including diabetes mellitus and obesity. The adverse events are preceded by acute worsening of oral glucose tolerance (oGTT along with reduced plasma free fatty acids (FFA and leptin in animal models. It is unclear whether the same acute effects occur in humans.A double blind, randomized, placebo-controlled crossover trial was conducted to examine the potential metabolic effects of olanzapine in healthy volunteers. Participants included male (8 and female (7 subjects [18-30 years old, BMI 18.5-25]. Subjects received placebo or olanzapine (10 mg/day for three days prior to oGTT testing. Primary endpoints included measurement of plasma leptin, oral glucose tolerance, and plasma free fatty acids (FFA. Secondary metabolic endpoints included: triglycerides, total cholesterol, high- and low-density lipoprotein cholesterol, heart rate, blood pressure, body weight and BMI. Olanzapine increased glucose Area Under the Curve (AUC by 42% (2808±474 vs. 3984±444 mg/dl·min; P = 0.0105 during an oGTT. Fasting plasma leptin and triglycerides were elevated 24% (Leptin: 6.8±1.3 vs. 8.4±1.7 ng/ml; P = 0.0203 and 22% (Triglycerides: 88.9±10.1 vs. 108.2±11.6 mg/dl; P = 0.0170, whereas FFA and HDL declined by 32% (FFA: 0.38±0.06 vs. 0.26±0.04 mM; P = 0.0166 and 11% (54.2±4.7 vs. 48.9±4.3 mg/dl; P = 0.0184, respectively after olanzapine. Other measures were unchanged.Olanzapine exerts some but not all of the early endocrine/metabolic changes observed in rodent models of the metabolic side effects, and this suggest that antipsychotic effects are not limited to perturbations in glucose metabolism alone. Future prospective clinical studies should focus on identifying which reliable metabolic alterations might be useful as potential screening tools in assessing patient susceptibility to weight gain and diabetes caused by atypical NCT00741026.

  18. Serum prolactin level in patients taking olanzapine

    Diganta Das


    Full Text Available Introduction: Olanzapine is a commonly used antipsychotic. Prolactin elevation is a common adverse effect of anstipsychotics, and serum prolactin elevation is seen in about 30% patients treated with olanzapine. There are confounding results about dose dependency of olanzapine and prolactin elevation, and also the duration of treatment. Method: Fifty six patients, 36 male and 20 female, who were taking olanzapine for any condition for more than a month at a constant dose were enrolled in the study. Patients’ age, weight, body mass index (BMI, serum prolactin levels, and some biochemical values were recorded. Patients were taken from the review outpatient department (OPD after due consent. Results: Five each in male and female groups showed elevation of serum prolactin (estimated to be high if >20 ng/dl for males, and >25 ng/dl for females. In females, the elevation was found at lesser dose of olanzapine (13 mg/day, in males 18 mg/day and early in the treatment (2.4 months vs. 9.7 months in males. Males tended to show raised prolactin with higher doses of olanzapine (mean 18 mg/day. Females (26.31% also showed higher prevalence of prolactin elevation compared to males (13.51%. No other parameter was found to modify the prolactin levels. Conclusion: Olanzapine causes elevation of serum prolactin, though lesser degree than some other antipsychotics. Females are more prone to have raised serum prolactin with olanzapine compared to males. However, the elevation seems to be transient. Higher doses of olanzapine tend to cause elevation of serum prolactin. Serum prolactin estimation in patients taking olanzapine may be undertaken to maintain quality life, particularly in females.

  19. Hypomania after augmenting venlafaxine and olanzapine with sarcosine in a patient with schizophrenia: a case study

    Strzelecki D


    Full Text Available Dominik Strzelecki, Justyna Szyburska, Magdalena Kotlicka-Antczak, Olga KałużyńskaDepartment of Affective and Psychotic Disorders, Medical University of Lódz, Central Clinical Hospital, Lódz, PolandAbstract: Glutamate is the main excitatory neurotransmitter in the central nervous system. Dysfunction of the glutamatergic system plays an important and well-established role in the pathogenesis of schizophrenia. Agents with glutamatergic properties such as N-methyl-D-aspartate receptor coagonists (ie, glycine, D-cycloserine and glycine transporter type 1 inhibitors (eg, sarcosine, bitopertin are investigated in schizophrenia with special focus on negative and cognitive symptomatology. In this article, we describe a case of a 34-year-old woman with diagnosis of schizophrenia with persistent moderate negative and cognitive symptoms, a participant of the Polish Sarcosine Study (PULSAR treated with olanzapine (25 mg per day and venlafaxine (75 mg per day. During ten weeks of sarcosine administration (2 g per day the patient’s activity and mood improved, but in the following 2 weeks, the patient reported decreased need for sleep, elevated mood, libido and general activity. We diagnosed drug-induced hypomania and recommended decreasing the daily dose of venlafaxine to 37.5 mg per day, which resulted in normalization of mood and activity in about 1 week. After this change, activity and mood remained stable and better than before adding sarcosine, and subsequent depressive symptoms were not noted. We describe here the second case report where sarcosine induced important affect changes when added to antidepressive and antipsychotic treatment, which supports the hypothesis of clinically important glutamate–serotonin interaction.Keywords: MNDA receptor, glutamatergic system, serotoninergic system

  20. Comparative study of adverse effects of Olanzapine and Risperidone on blood suger, lipid and other side effects in psychotic disorders

    mitra safa


    Full Text Available Safa M1, Mohammadi MR2, Saki M3, Delfan B4, Tarrahi MJ5, Rouhandeh M6 1. Assistant Professor, Department of psychiatry, Faculty of Medicine, Lorestan University of Medical Sciences, Khorramabad, Iran 2. GP, Khorramabad, Iran 3. Instructor, Department of Nursing, Faculty of Nursing and Midwifery, Lorestan University of Medical Sciences, Khorramabad, Iran 4. Associate Professor, Department of Pharmacology, Faculty of Medicine, Lorestan University of Medical Sciences, Khorramabad, Iran 5. Instructor, Department of Epidemiology, Faculty of Health, Lorestan University of Medical Sciences, Khorramabad, Iran 6. BSc in Nursing, Khorramabad, Iran Abstract Background: Chronic mental disorders are among the problems in psychiatrics. Atypical anti psychotic drugs are new effective medications to treat these disorders. Unfortunately these drugs lead to side effects such as increase in blood glocuse, weight gain and edema. This study aims to investigate adverse effects of Olanzapine and Rispridone on lipid level and blood glocuse and other complications in patients with psychotic disorders. Materials and methods: This clinical trial-double blinded study, patients with psychotic disorders were randomly categorized into two groups. Group one treated with Olanzapine and other with Rispridone. All the subjects were initially assessed for blood sugar and lipids, and in the case of normal, they were randomly assigned to two groups in a double- blinded method to be treated with Olanzapine or Risperidone. Blood sugar and lipids tests were performed for all subjects at the 1st week and 3 months after initiation of therapy. Other complications were assessed too, then the data were analyzed using SPSS software. Results: The results of the study indicated that the levels of cholesterol, triglycerides and blood suger rose significantly at the 1st week and third month after beginning the treatment. Increase of cholesterol and triglyceride in the Olanzapine and Risperidone


    G N S Sangeetha Lakshmi


    Full Text Available Background: Schizophrenia is a mental disorder characterized by persistent defects in the perception, thinking or the expression of reality. The term “schizophrenia” translates roughly as “shattered mind,” and comes from the Greek (schizo, “to split” or “to divide” and (phrēn, “mind”. Material and Methods: The study was designed to be a prospective control study. Schizophrenic patients taking Olanzapine and Haloperidol were selected and follow up at three weeks and six weeks was done. Results: In this prospective control study, Olanzapine and Haloperidol were associated with an increase in Blood Glucose Levels. The mean changes in Glucose remained within clinically normal range in this six week study. Conclusion: Antipsychotic treatmemt leads to the development of Diabetes mellitus in a significant 10.1% of patients within 6 weeks. Given the serious implications for morbidity and mortality attributable to diabetes mellitus, clinicians need to be aware of these risk factors when treating patients with chronic schizophrenia

  2. Obsessive-compulsive symptoms during treatment with olanzapine and risperidone: A prospective study of 113 patients with recent-onset schizophrenia or related disorders

    de Haan, Lieuwe; Beuk, Nico; Hoogenboom, Britt; Dingemans, Peter; Linszen, Don


    Objective: To determine whether severity of obsessive-compulsive symptoms (OCS) differs during treatment with olanzapine or risperidone and to establish whether duration of antipsychotic treatment is related to severity of OCS. Method: We conducted a prospective study of consecutively hospitalized

  3. Olanzapine induced Q-Tc shortening.

    Shoja Shafti, Saeed; Fallah Jahromi, Parisa


    Prolongation of Q-Tc interval is commonly accepted as a surrogate marker for the ability of a drug to cause torsade de pointes. In the present study, safety of olanzapine versus risperidone was compared among a group of patients with schizophrenia to see the frequency of the electrocardiographic alterations induced by those atypical antipsychotics. Two hundred and sixty-eight female inpatients with schizophrenia entered in one of the two parallel groups to participate in an open study for random assignment to olanzapine (n = 148) or risperidone (n = 120). Standard 12-lead surface electrocardiogram (ECG) was taken from each patient at baseline, before initiation of treatment, and then at the end of management, just before discharge. The parameters that were assessed included heart rate (HR), P-R interval, QRS interval, Q-T interval (corrected = Q-Tc), ventricular activation time (VAT), ST segment, T wave, axis of QRS, and finally, interventricular conduction process. A total of 37.83% of cases in the olanzapine group and 30% in the risperidone group showed some Q-Tc changes; 13.51% and 24.32% of the patients in the olanzapine group showed prolongation and shortening of the Q-Tc, respectively, while changes in the risperidone group were restricted to only prolongation of Q-Tc. Comparison of means showed a significant increment in Q-Tc by risperidone (p = 0.02). Also, comparison of proportions in the olanzapine group showed significantly more cases with shortening of Q-Tc versus its prolongation (p = 0.01). No significant alterations with respect to other variables were evident. Olanzapine and risperidone had comparable potentiality for induction of Q-Tc changes, while production of further miscellaneous alterations in ECG was more observable in the olanzapine group compared with the risperidone group. Also shortening of Q-Tc was specific to olanzapine.

  4. Postinjection delirium/sedation syndrome in patients with schizophrenia receiving olanzapine long-acting injection: results from a large observational study.

    Meyers, Kristin J; Upadhyaya, Himanshu P; Landry, John L; Chhabra-Khanna, Rashna; Falk, Deborah M; Seetharama Rao, Balasubramanya; Jones, Meghan E


    Postinjection delirium/sedation syndrome (PDSS) has been reported uncommonly during treatment with olanzapine long-acting injection (LAI), a sustained-release formulation of olanzapine. The primary aim of the study was to estimate the incidence per injection and per patient of PDSS events in adult patients with schizophrenia who were receiving olanzapine LAI in real-world clinical practice. Secondary aims were to further characterise the clinical presentation of PDSS events, to identify potential risk factors associated with PDSS events and to characterise hospitalisations at baseline and post-baseline. A prospective observational study of adult patients with schizophrenia receiving olanzapine LAI from 24 countries. Data were collected on patient characteristics, olanzapine LAI treatment and any adverse events (AEs). All AEs were reviewed and adjudicated for PDSS using predetermined criteria. There were 46 confirmed PDSS events (0.044% of the 103 505 injections) in 45 patients (1.17% of the 3858 patients). Based on 45 confirmed events with time-to-onset information, 91.1% ( n =41) occurred within 1 h of injection. Time-to-recovery from the event was within 72 h for 95.6% of patients (range 6 h to 11 days). Risk factors for PDSS (per-injection) included high dose (odds ratio (OR) high/low =3.95; P =0.006) and male gender (OR female/male =0.42; P =0.017). Results of this study confirm previously reported PDSS rates, time to onset and recovery, and the severity of PDSS events, and suggest that higher doses and male gender are potential risk factors associated with PDSS. All authors are full-time employees and hold stock/stock options in Eli Lilly, which funded this study. This post-authorisation safety study (PASS) was proposed by Eli Lilly when submitting the original marketing authorisation application for olanzapine LAI in 2007. The protocol and final study report for this European Union regulatory commitment are publicly accessible via the European Network of

  5. Frequency of sexual dysfunction and other reproductive side-effects in patients with schizophrenia treated with risperidone, olanzapine, quetiapine, or haloperidol: the results of the EIRE study.

    Bobes, J; Garc A-Portilla, M P; Rejas, J; Hern Ndez, G; Garcia-Garcia, M; Rico-Villademoros, F; Porras, A


    Atypical antipsychotics seem to differ mainly in their tolerability profile. The aim of this cross-sectional study, the Estudio de Investigaci n de Resultados en Esquizofrenia (Outcomes Research Study in Schizophrenia; EIRE study), was to assess in a clinical setting the frequency of several side-effects related to haloperidol, risperidone, olanzapine, and quetiapine. This article addresses sexual dysfunction and other reproductive side-effects (gynecomastia, menorrhage, amenorrhea, and galactorrhea). We recruited outpatients diagnosed with schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV; American Psychiatric Association, 1994) criteria and who had received a single antipsychotic (risperidone, olanzapine, quetiapine, or haloperidol) for at least 4 weeks. During a single visit, we collected data, including demographic and clinical characteristics, current antipsychotic and concomitant treatment, and adverse effects listed in a modified version of the UKU Scale. We used a Chi-squared test to determine pairs comparisons of the frequency of adverse reactions between treatments. To estimate risk of a given adverse reaction with a given treatment, we used a logistic regression method. We assessed 636 evaluable patients out of 669 recruited. Frequency of sexual dysfunction was high with haloperidol (38.1%) and also with olanzapine (35.3%), quetiapine (18.2%), and risperidone (43.2%). We found the frequency of other reproductive side-effects to be relatively low with all four drugs: haloperidol (6.9%), olanzapine (6.4%), quetiapine (2.7%), and risperidone (11.7%). Sexual dysfunction appeared to be dose-related with haloperidol, risperidone, and olanzapine. Risperidone and olanzapine showed a higher risk of sexual dysfunction and other reproductive sideeffects than haloperidol. Quetiapine showed a lower risk of sexual dysfunction during short-term treatment ( 12 weeks) are lacking. Our results suggest that none of the atypical

  6. A Phase II study of palonosetron, aprepitant, dexamethasone and olanzapine for the prevention of cisplatin-based chemotherapy-induced nausea and vomiting in patients with thoracic malignancy.

    Nakashima, Kazuhisa; Murakami, Haruyasu; Yokoyama, Kouichi; Omori, Shota; Wakuda, Kazushige; Ono, Akira; Kenmotsu, Hirotsugu; Naito, Tateaki; Nishiyama, Fumie; Kikugawa, Mami; Kaneko, Masayo; Iwamoto, Yumiko; Koizumi, Satomi; Mori, Keita; Isobe, Takeshi; Takahashi, Toshiaki


    The three-drug combination of a 5-hydroxytryptamine type 3 receptor antagonist, a neurokinin 1 receptor antagonist and dexamethasone is recommended for patients receiving highly emetogenic chemotherapy. However, standard antiemetic therapy is not completely effective in all patients. We conducted an open-label, single-center, single-arm Phase II study to evaluate the efficacy of olanzapine in combination with standard antiemetic therapy in preventing chemotherapy-induced nausea and vomiting in patients with thoracic malignancy receiving their first cycle of cisplatin-based chemotherapy. Patients received 5 mg oral olanzapine on Days 1-5 in combination with standard antiemetic therapy. The primary endpoint was complete response (no vomiting and no use of rescue therapy) during the overall Phase (0-120 h post-chemotherapy). Twenty-three men and seven women were enrolled between May and October 2015. The median age was 64 years (range: 36-75 years). The most common chemotherapy regimen was 75 mg/m2 cisplatin and 500 mg/m2 pemetrexed, which was administered to 14 patients. Complete response rates in acute (0-24 h post-chemotherapy), delayed (24-120 h post-chemotherapy) and overall phases were 100%, 83% and 83% (90% confidence interval: 70-92%; 95% confidence interval: 66-93%), respectively. There were no Grade 3 or Grade 4 adverse events. Although four patients (13%) experienced Grade 1 somnolence, no patients discontinued olanzapine. The addition of 5 mg oral olanzapine to standard antiemetic therapy demonstrates promising efficacy in preventing cisplatin-based chemotherapy-induced nausea and vomiting and an acceptable safety profile in patients with thoracic malignancy. © The Author 2017. Published by Oxford University Press. All rights reserved. For permissions, please e-mail:

  7. LC–MS/MS assay for olanzapine in human plasma and its application to a bioequivalence study

    Dinesh S. Patel


    Full Text Available This paper describes a selective and sensitive assay for the determination of olanzapine (OLZ in human plasma based on liquid chromatography–tandem mass spectrometry (LC–MS/MS. The analyte and quetiapine as internal standard (IS were extracted from 200 μL plasma via solid phase extraction on Waters Oasis HLB cartridges. Chromatographic separation was achieved on an ACE 5C18-300 column (100 mm×4.6 mm, 5 μm under isocratic conditions in a run time of 3.5 min. Mass spectrometric detection involved electrospray ionization in the positive ion mode followed by multiple reaction monitoring (MRM of the transitions at m/z 313/256 for OLZ and m/z 384/253 for the IS. The assay was linear in the range 0.10–40.0 ng/mL with a lower limit of quantitation and limit of detection of 0.10 and 0.012 ng/mL, respectively. Intra- and inter-day precision (as coefficient of variation and relative recovery were 90%, respectively. The method was successfully applied to a bioequivalence study of 5 and 10 mg OLZ disintegrating tablets in 40 healthy Indian males with reproducibility by incurred sample reanalysis in the range −7.43 to 8.07%.

  8. Orally disintegrating and oral standard olanzapine tablets similarly elevate the homeostasis model assessment of insulin resistance index and plasma triglyceride levels in 12 healthy men: a randomized crossover study.

    Vidarsdottir, Solrun; Vlug, Pauline; Roelfsema, Ferdinand; Frölich, Marijke; Pijl, Hanno


    Treatment with olanzapine is associated with obesity, diabetes mellitus, and dyslipidemia. Reports have indicated that orally disintegrating tablets (ODT) cause less weight gain than oral standard tablets (OST). The aim of this study was to compare the effect of short-term treatment with these 2 distinct olanzapine formulations on glucose and lipid metabolism in healthy men. Twelve healthy men (mean ± SEM age: 25.1 ± 5.5 years) received olanzapine ODT (10 mg od, 8 days), olanzapine OST (10 mg od, 8 days), or no intervention in a randomized crossover design. At breakfast and dinner, glucose, insulin, free fatty acids (FFA), and triglyceride concentrations were measured at 10-minute intervals from 30 minutes prior to 2 hours after ingestion of standard meals. Leptin and adiponectin concentrations were measured at 20- and 30-minute intervals, respectively, between 0000h-1200h. Physical activity was assessed with an accelerometer. Fuel oxidation was measured in fasting condition by indirect calorimetry. The study was conducted from April 2006 through September 2006. Treatment with olanzapine ODT and OST equally elevated the homeostasis model assessment of insulin resistance (HOMA-IR) (P = .005). At breakfast, both formulations equally increased fasting and postprandial triglyceride concentrations (P = .013 and P = .005, respectively) while decreasing fasting and postprandial FFA concentrations (P = .004 and P = .009, respectively). Body weight, body composition, physical activity, or fuel oxidation did not differ between treatment modalities. Eight days of treatment with both olanzapine formulations similarly increased HOMA-IR and triglyceride concentrations and decreased FFA concentrations in response to standard meals without affecting anthropometrics or physical activity. These data suggest that olanzapine hampers insulin action via mechanistic routes other than body adiposity or physical inactivity. Identifier: ISRCTN17632637. © Copyright

  9. Comparison of intramuscular olanzapine, orally disintegrating olanzapine tablets, oral risperidone solution, and intramuscular haloperidol in the management of acute agitation in an acute care psychiatric ward in Taiwan.

    Hsu, Wen-Yu; Huang, Si-Sheng; Lee, Bo-Shyan; Chiu, Nan-Ying


    The purpose of this study was to compare efficacy and safety among intramuscular olanzapine, intramuscular haloperidol, orally disintegrating olanzapine tablets, and oral risperidone solution for agitated patients with psychosis during the first 24 hours of treatment in an acute care psychiatric ward. Forty-two inpatients from an acute care psychiatric ward of a medical center in central Taiwan were enrolled. They were randomly assigned to 1 of the 4 treatment groups (10-mg intramuscular olanzapine, 10-mg olanzapine oral disintegrating tablet, 3-mg oral risperidone solution, or 7.5-mg intramuscular haloperidol). Agitation was measured by using the excited component of the Positive and Negative Syndrome Scale (PANSS-EC), the Agitation-Calmness Evaluation Scale, and the Clinical Global Impression--Severity Scale during the first 24 hours. There were significant differences in the PANSS-EC total scores for the 4 intervention groups at 15, 30, 45, 60, 75, and 90 minutes after the initiation of treatment. More significant differences were found early in the treatment. In the post hoc analysis, the patients who received intramuscular olanzapine or orally disintegrating olanzapine tablets showed significantly greater improvement in PANSS-EC scores than did patients who received intramuscular haloperidol at points 15, 30, 45, 60, 75, and 90 minutes after injection. These findings suggest that intramuscular olanzapine, orally disintegrating olanzapine tablets, and oral risperidone solution are as effective treatments as intramuscular haloperidol for patients with acute agitation. Intramuscular olanzapine and disintegrating olanzapine tablets are more effective than intramuscular haloperidol in the early phase of the intervention. There is no significant difference in effectiveness among intramuscular olanzapine, orally disintegrating olanzapine tablets, and oral risperidone solution.

  10. Metabolic effects of Olanzapine versus Iloperidone: A 24 weeks ...

    Arun Kumar Agnihotri

    The present study is aimed to comparatively evaluate the metabolic profile of olanzapine and iloperidone in cases of ... delusional disorders, acute and transient psychotic ... Data regarding age, sex, socio-economic status, family history, and.

  11. Intramuscular Olanzapine – a UK case series of early cases

    Taylor Mark


    Full Text Available Abstract Background Clinical trials assessing efficacy and safety of Intramuscular (IM Olanzapine in acute schizophrenia and acute mania have previously been undertaken in studies required for drug registration in patients who were required to give informed consent. These patients may have less severe forms of psychosis than patients treated in routine practice. Data derived from naturalistic practice following the launch of IM olanzapine may be helpful for clinicians in assessing efficacy and safety of IM olanzapine. The PANSS-EC scale used in the clinical studies may represent a tool that could be used in routine clinical practice. Case presentation We report on an early unselected case series of 7 patients who received IM olanzapine in routine clinical practice settings in the UK. In this case series, olanzapine IM was generally effective, and no adverse events were reported. Adjunctive benzodiazepines were given concomitantly in 1 of the 7 subjects. This is relevant as concomitant benzodiazepines are not recommended for a minimum of 1 hour post IM olanzapine administration. PANSS-EC data was collected in 2 of the 7 subjects. Conclusion Although patients had greater severity of psychosis than clinical trial patients there were no unexpected findings. In addition the PANSS-EC scale is a scale that may be useful in assessing the efficacy of IM antipsychotics in routine clinical practice.

  12. [Prescription of olanzapine in children and adolescent psychiatric patients].

    Frémaux, T; Reymann, J-M; Chevreuil, C; Bentué-Ferrer, D


    A review of the literature from 1996-2004 on the indications and adverse reactions concerning the use of olanzapine, a second generation antipsychotic agent, in children and adolescents with psychiatric illness is made in this article. Studies lasted for 2 to 3 months and a few had a follow up period up to a year. Olanzapine, dosed from 2.5 to 20 mg/day, is shown to be a useful drug in the treatment of child and adolescent onset schizophrenia, bipolar disorder, anorexia nervosa with delusions, pervasive developmental disorder, tic disorders, and aggression. OPEN AND DOUBLE-BLIND STUDIES: In 4 open labeled studies (26, 34, 39, 43) and 2 case reports (25), 53 patients, aged from 6-18 years old, afflicted by child onset schizophrenia, were treated with olanzapine for 1 1/2 weeks to one year; 19 had treatment resistant childhood schizophrenia and 34 a first episode. In the first group 13/19 showed improvement whereas, in the second group 27/34 were considered responders. Four patients in the first group who had responded to clozapine (stopped because of adverse events) did less well on olanzapine. In 5 studies, 4 open labeled (15, 20, 44) and 1 double blind (27), 59 adolescent onset schizophrenic patients were treated by olanzapine from 8 to 26 weeks; 50/59 patients were considered responders. In the open label study (20) comparing 43 adolescents treated by olanzapine (19 patients), risperidone (17 patients), or haloperidol (7 patients), improvement was significant in the three groups after 4 weeks of treatment and continued after 8 weeks. It is most interesting to mention that 2 months after the end of the study 71% (12/17) of the olanzapine group that had completed the study, 10/15 (67%) of the risperidone group, and 43% (3/7) of the haloperidol group had continued their treatment. Dropouts were for inefficacy and non-compliance in the olanzapine and risperidone groups whereas they were also for adverse events in the haloperidol group (2/4). A final double blind

  13. The Importance of Pilot Studies

    Van Teijlingen, Edwin; Hundley, Vanora


    The term 'pilot studies' refers to mini versions of a full-scale study (also called 'feasibility' studies), as well as the specific pre-testing of a particular research instrument such as a questionnaire or interview schedule. \\ud Pilot studies are a crucial element of a good study design. Conducting a pilot study does not guarantee success in the main study, but it does increase the likelihood. \\ud Pilot studies fulfil a range of important functions and can provide valuable insights for othe...

  14. A single-dose, randomized, two-way crossover study comparing two olanzapine tablet products in healthy adult male volunteers under fasting conditions.

    Elshafeey, Ahmed H; Elsherbiny, Mohamed A; Fathallah, Mohsen M


    Olanzapine is a psychotropic agent that belongs to the thienobenzodiazepine class. The aim of this study was to assess the bioequivalence of 2 commercial 10-mg tablet formulations of olanzapine by statistical analysis of the pharmacokinetic parameters C(max), AUC from 0 to 72 hours after dosing (AUC(0-72)), and AUC(0-infinity) as required by the Egyptian health authority for the marketing of a generic product. This bioequivalence study was carried out in healthy male volunteers using a single-dose, randomized, 2-way crossover design under fasting conditions. Statistical analysis of the pharmacokinetic parameters C(max), AUC(0-72), and AUC(0-infinity) was conducted to determine bioequivalence (after log-transformation of data using analysis of variance and 90% CIs) and to gain marketing approval in Egypt. The formulations were considered to be bioequivalent if the log-transformed ratios of the 3 pharmacokinetic parameters were within the predetermined bioequivalence range (ie, 80%-125%), as established by the US Food and Drug Administration (FDA). Both the test product (Trademark: Integrol((R)) [Global Napi Pharmaceuticals, Cairo, Egypt]) and the reference product (Trademark: Zyprexa((R)) [Eli Lilly and Company, Basingstoke, Hampshire, United Kingdom]) were administered as 10-mg tablets with 240 mL of water after an overnight fast on 2 treatment days, separated by a 2-week washout period. After dosing, serial blood samples were collected for 72 hours. Plasma samples were analyzed using a sensitive, reproducible, and accurate liquid chromatography-tandem mass spectrometry method capable of quantitating olanzapine in the range of 0.167 to 16.7 ng/mL, with a lower limit of quantitation of 0.167 ng/mL. Adverse events were reported by the volunteers as instructed or observed by the resident physician, and were recorded, tabulated, and evaluated. Twenty-four healthy adult male volunteers participated in this study. Their mean (SD) age was 24.7 (6.2) years (range, 19

  15. Long-term functional improvements in the 2-year treatment of schizophrenia outpatients with olanzapine long-acting injection

    Ascher-Svanum H


    Full Text Available Haya Ascher-Svanum,1 Diego Novick,2,3 Josep Maria Haro,4 Jordan Bertsch,4 David McDonnell,1 Holland Detke11Eli Lilly and Company, Indianapolis, IN, USA; 2Eli Lilly and Company, Windlesham, Surrey, UK; 3Departament de Psiquiatria, Universitat Autonoma de Barcelona, Spain; 4Parc Sanitari Sant Joan de Déu, Centro de Investigación Biomédica en Red en el Área de Salud Mental, Universitat de Barcelona, Barcelona, SpainBackground: Little is known about the long-term changes in the functioning of schizophrenia patients receiving maintenance therapy with olanzapine long-acting injection (LAI, and whether observed changes differ from those seen with oral olanzapine.Methods: This study describes changes in the levels of functioning among outpatients with schizophrenia treated with olanzapine-LAI compared with oral olanzapine over 2 years. This was a secondary analysis of data from a multicenter, randomized, open-label, 2-year study comparing the long-term treatment effectiveness of monthly olanzapine-LAI (405 mg/4 weeks; n=264 with daily oral olanzapine (10 mg/day; n=260. Levels of functioning were assessed with the Heinrichs–Carpenter Quality of Life Scale. Functional status was also classified as “good”, “moderate”, or “poor”, using a previous data-driven approach. Changes in functional levels were assessed with McNemar’s test and comparisons between olanzapine-LAI and oral olanzapine employed the Student’s t-test. Results: Over the 2-year study, the patients treated with olanzapine-LAI improved their level of functioning (per Quality of Life total score from 64.0–70.8 (P<0.001. Patients on oral ­olanzapine also increased their level of functioning from 62.1–70.1 (P<0.001. At baseline, 19.2% of the olanzapine-LAI-treated patients had a “good” level of functioning, which increased to 27.5% (P<0.05. The figures for oral olanzapine were 14.2% and 24.5%, respectively (P<0.001. Results did not significantly differ between

  16. Dose reduction of risperidone and olanzapine can improve cognitive function and negative symptoms in stable schizophrenic patients: A single-blinded, 52-week, randomized controlled study.

    Zhou, Yanling; Li, Guannan; Li, Dan; Cui, Hongmei; Ning, Yuping


    The long-term effects of dose reduction of atypical antipsychotics on cognitive function and symptomatology in stable patients with schizophrenia remain unclear. We sought to determine the change in cognitive function and symptomatology after reducing risperidone or olanzapine dosage in stable schizophrenic patients. Seventy-five stabilized schizophrenic patients prescribed risperidone (≥4 mg/day) or olanzapine (≥10 mg/day) were randomly divided into a dose-reduction group ( n=37) and a maintenance group ( n=38). For the dose-reduction group, the dose of antipsychotics was reduced by 50%; for the maintenance group, the dose remained unchanged throughout the whole study. The Positive and Negative Syndrome Scale, Negative Symptom Assessment-16, Rating Scale for Extrapyramidal Side Effects, and Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery were measured at baseline, 12, 28, and 52 weeks. Linear mixed models were performed to compare the Positive and Negative Syndrome Scale, Negative Symptom Assessment-16, Rating Scale for Extrapyramidal Side Effects and MATRICS Consensus Cognitive Battery scores between groups. The linear mixed model showed significant time by group interactions on the Positive and Negative Syndrome Scale negative symptoms, Negative Symptom Assessment-16, Rating Scale for Extrapyramidal Side Effects, speed of processing, attention/vigilance, working memory and total score of MATRICS Consensus Cognitive Battery (all pNegative Syndrome Scale negative subscale, Negative Symptom Assessment-16, Rating Scale for Extrapyramidal Side Effects, speed of processing, working memory and total score of MATRICS Consensus Cognitive Battery for the dose reduction group compared with those for the maintenance group (all pnegative symptoms in patients with stabilized schizophrenia.

  17. Metformin and berberine prevent olanzapine-induced weight gain in rats.

    Yueshan Hu

    Full Text Available Olanzapine is a first line medication for the treatment of schizophrenia, but it is also one of the atypical antipsychotics carrying the highest risk of weight gain. Metformin was reported to produce significant attenuation of antipsychotic-induced weight gain in patients, while the study of preventing olanzapine-induced weight gain in an animal model is absent. Berberine, an herbal alkaloid, was shown in our previous studies to prevent fat accumulation in vitro and in vivo. Utilizing a well-replicated rat model of olanzapine-induced weight gain, here we demonstrated that two weeks of metformin or berberine treatment significantly prevented the olanzapine-induced weight gain and white fat accumulation. Neither metformin nor berberine treatment demonstrated a significant inhibition of olanzapine-increased food intake. But interestingly, a significant loss of brown adipose tissue caused by olanzapine treatment was prevented by the addition of metformin or berberine. Our gene expression analysis also demonstrated that the weight gain prevention efficacy of metformin or berberine treatment was associated with changes in the expression of multiple key genes controlling energy expenditure. This study not only demonstrates a significant preventive efficacy of metformin and berberine treatment on olanzapine-induced weight gain in rats, but also suggests a potential mechanism of action for preventing olanzapine-reduced energy expenditure.

  18. In vivo effects of olanzapine on striatal dopamine D[sub 2]/D[sub 3] receptor binding in schizophrenic patients: an iodine-123 iodobenzamide single-photon emission tomography study

    Dresel, S.; Rossmueller, B.; Hahn, K.; Tatsch, K. (Department of Nuclear Medicine, University of Munich (Germany)); Mager, T.; Meisenzahl, E.; Moeller, H.J. (Department of Psychiatry, University of Munich (Germany))


    Olanzapine is a new atypical antipsychotic agent that belongs to the same chemical class as clozapine. The pharmacological efficacy of olanzapine (in contrast to that of risperidone) has been shown to be comparable to that of clozapine, but olanzapine has the advantage of producing a less pronounced bone marrow depressing effect than clozapine. The specific aims of this study were (a) to assess dopamine D[sub 2]/D[sub 3] receptor availability in patients treated with olanzapine by means of iodine-123 iodobenzamide [[sup 123]I]IBZM single-photon emission tomography (SPET), (b) to compare the results with findings of [[sup 123]I]IBZM SPET in patients under treatment with risperidone and (c) to correlate the results with the occurrance of extrapyramidal side-effects (EPMS). Brain SPET scans were performed in 20 schizophrenic patients (DSM III R) at 2 h after i.v. administration of 185 MBq [[sup 123]I]IBZM. Images were acquired using a triple-head gamma camera (Picker Prism 3000 XP). For semiquantitative evaluation of D[sub 2]/D[sub 3] receptor binding, transverse slices corrected for attenuation were used to calculate specific uptake values [STR-BKG]/BKG (STR=striatum; BKG=background). The mean daily dose of olanzapine ranged from 0.05 to 0.6 mg/kg body weight. The dopamine D[sub 2]/D[sub 3] receptor binding was reduced in all patients treated with olanzapine. Specific IBZM binding [STR-BKG]/BKG ranged from 0.13 to 0.61 (normal controls >0.95). The decreased D[sub 2]/D[sub 3] receptor availability revealed an exponential dose-response relationship (r=-0.85, P<0.001). The slope of the curve was similar to that of risperidone and considerably higher than that of clozapine as compared with the results of a previously published study. EPMS were observed in only one patient, presenting with the lowest D[sub 2]/D[sub 3] availability. The frequency of EPMS induced by olanzapine (5%) was considerably lower than the frequency under risperidone treatment (40%). Our findings

  19. In vivo effects of olanzapine on striatal dopamine D{sub 2}/D{sub 3} receptor binding in schizophrenic patients: an iodine-123 iodobenzamide single-photon emission tomography study

    Dresel, S.; Rossmueller, B.; Hahn, K.; Tatsch, K. [Department of Nuclear Medicine, University of Munich (Germany); Mager, T.; Meisenzahl, E.; Moeller, H.J. [Department of Psychiatry, University of Munich (Germany)


    Olanzapine is a new atypical antipsychotic agent that belongs to the same chemical class as clozapine. The pharmacological efficacy of olanzapine (in contrast to that of risperidone) has been shown to be comparable to that of clozapine, but olanzapine has the advantage of producing a less pronounced bone marrow depressing effect than clozapine. The specific aims of this study were (a) to assess dopamine D{sub 2}/D{sub 3} receptor availability in patients treated with olanzapine by means of iodine-123 iodobenzamide [{sup 123}I]IBZM single-photon emission tomography (SPET), (b) to compare the results with findings of [{sup 123}I]IBZM SPET in patients under treatment with risperidone and (c) to correlate the results with the occurrance of extrapyramidal side-effects (EPMS). Brain SPET scans were performed in 20 schizophrenic patients (DSM III R) at 2 h after i.v. administration of 185 MBq [{sup 123}I]IBZM. Images were acquired using a triple-head gamma camera (Picker Prism 3000 XP). For semiquantitative evaluation of D{sub 2}/D{sub 3} receptor binding, transverse slices corrected for attenuation were used to calculate specific uptake values [STR-BKG]/BKG (STR=striatum; BKG=background). The mean daily dose of olanzapine ranged from 0.05 to 0.6 mg/kg body weight. The dopamine D{sub 2}/D{sub 3} receptor binding was reduced in all patients treated with olanzapine. Specific IBZM binding [STR-BKG]/BKG ranged from 0.13 to 0.61 (normal controls >0.95). The decreased D{sub 2}/D{sub 3} receptor availability revealed an exponential dose-response relationship (r=-0.85, P<0.001). The slope of the curve was similar to that of risperidone and considerably higher than that of clozapine as compared with the results of a previously published study. EPMS were observed in only one patient, presenting with the lowest D{sub 2}/D{sub 3} availability. The frequency of EPMS induced by olanzapine (5%) was considerably lower than the frequency under risperidone treatment (40%). Our findings

  20. 5-Lipoxygenase-Activating Protein as a Modulator of Olanzapine-Induced Lipid Accumulation in Adipocyte

    Svetlana Dzitoyeva


    Full Text Available Experiments were performed in 3T3-L1 preadipocytes differentiated in vitro into adipocytes. Cells were treated with olanzapine and a 5-lipoxygenase (5-LOX activating protein (FLAP inhibitor MK-886. Lipid content was measured using an Oil Red O assay; 5-LOX and FLAP mRNA content was measured using quantitative real-time PCR; the corresponding protein contents were measured using quantitative Western blot assay. Olanzapine did not affect the cell content of 5-LOX mRNA and protein; it decreased FLAP mRNA and protein content at day five but not 24 hours after olanzapine addition. In the absence of MK-886, low concentrations of olanzapine increased lipid content only slightly, whereas a 56% increase was induced by 50 μM olanzapine. A 5-day cotreatment with 10 μM MK-886 potentiated the lipid increasing action of low concentrations of olanzapine. In contrast, in the presence of 50 μM olanzapine nanomolar and low micromolar concentrations of MK-886 reduced lipid content. These data suggest that FLAP system in adipocytes is affected by olanzapine and that it may modify how these cells respond to the second-generation antipsychotic drugs (SGADs. Clinical studies could evaluate whether the FLAP/5-LOX system could play a role in setting a variable individual susceptibility to the metabolic side effects of SGADs.

  1. Effect of olanzapine treatment on INR of a patient receiving warfarin therapy

    Derya Arslan


    Full Text Available Olanzapine is an atypical antipsychotic drug, commonly used in the management of psychotic symptoms in patients with schizoprenia and bipolar affective disorder. Deep venous thrombosis is a manifestation of venous thromboembolism. It is very well known that use of antipsychotic drugs increase the risk of thrombosis in a patient with schizophrenia. It has been reported in many studies the effects of olanzapine on thrombosis but there isn't any report about the effect of olanzapine on international normalized ratio (INR. in the medical literature. In this paper, a patient with schizophrenia and also family history of deep venous thrombosis who emerged deep venous thrombosis after being started on olanzapine treatment and effect of olanzapine treatment on INR has been reported. [Cukurova Med J 2016; 41(2.000: 370-373

  2. Oral glucose tolerance test performance in olanzapine-treated schizophrenia-spectrum patients is predicted by BMI and triglycerides but not olanzapine dose or duration.

    Guina, Jeffrey; Roy, Sayon; Gupta, Ankur; Langleben, Daniel D; Elman, Igor


    Olanzapine, an atypical antipsychotic, is associated with glucoregulatory abnormalities, but the nature of this link is not fully elucidated. This is the first olanzapine oral glucose tolerance test (oGTT) study to consider treatment dose and duration, and to compare complementary indices respectively assessing insulin sensitivity (Matsuda index) and resistance (homeostasis model assessment). Body mass index (BMI), body composition, plasma lipids, and oGTT were measured in olanzapine-treated nondiabetic patients with DSM-IV-TR diagnosis of schizophrenia or schizoaffective disorder (n = 35). While only one previously undiagnosed participant met diabetes criteria based on fasting plasma glucose alone (≥126 mg/dL), seven were diagnosed with oGTT (2-hr plasma glucose ≥200 mg/dL). Multiple regression analyses revealed that the Matsuda index correlated with BMI (p triglycerides (p = 0.01), but not with age, olanzapine dose, olanzapine treatment duration, or plasma cholesterol. Homeostasis model assessment and fasting plasma glucose correlated with triglycerides only (p triglycerides may be implicated in olanzapine-related glucoregulatory abnormalities. The lack of correlation between glucoregulatory abnormalities and olanzapine dose or treatment duration suggests preexisting metabolic disturbances and/or disturbances arising early in the course of treatment. Clinicians prescribing antipsychotics should consider oGTT, especially in patients with obesity and/or hypertriglyceridemia. Copyright © 2017 John Wiley & Sons, Ltd.

  3. Fitzmaurice Voicework Pilot Study.

    Watson, Lynn; Nayak, Sadhana


    A repeated-measures pilot study was used to investigate acoustic changes in the voices of participants in a Fitzmaurice Voicework (FV) teacher certification program. Maximum phonation time (MPT) was also measured. Eleven participants with no reported voice problems were studied. Pretraining and posttraining recordings were made of each participant. Measures of MPT were made, and the recordings were analyzed for jitter, shimmer, and noise-to-harmonics ratio (NHR). The measure of effect size for MPT was moderate, and there was an overall increase in MPT from pretraining to posttraining, with 70% of participants showing an increase in MPT. The measure of effect sizes for jitter, shimmer, and NHR were small, with measurements showing no significant changes from pretraining to posttraining. There were indications that FV training may have positive outcomes for actors and professional voice users, particularly in increasing MPT. Further studies with larger subject groups are needed to investigate the significance of the increase in MPT noted in this study and to test whether FV training can help to lower rates of shimmer and jitter. Copyright © 2015 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

  4. Doses of olanzapine, risperidone, and haloperidol used in clinical practice: results of a prospective pharmacoepidemiologic study. EFESO Study Group. Estudio Farmacoepidemiologico en la Esquizofrenia con Olanzapina.

    Sacristán, J A; Gómez, J C; Montejo, A L; Vieta, E; Gregor, K J


    The objectives of this study were to determine the doses of olanzapine (OLZ), risperidone (RIS), and haloperidol (HAL) used in clinical practice in outpatients with schizophrenia and the rates of occurrence of extrapyramidal symptoms (EPS) and other adverse events, clinical response, and use of concomitant medications. The present study involved a subset of patients from a 6-month, open-label, prospective observational study. Data were collected by 293 psychiatrists at mental health centers and other outpatient treatment facilities in Spain. Medications and doses used, occurrence of EPS and other adverse events, and scores on the Clinical Global Impression (CGI) of Severity Scale and Global Assessment of Function (GAF) were recorded. Clinical response was defined as a decrease of > or = 2 points on the CGI, with a final CGI score or = 5 received significantly higher overall mean daily doses than did patients with an initial CGI score < 5 (P < 0.001). A significantly lower proportion of OLZ-treated patients (10.2%) were receiving concomitant anticholinergic medication at the end of the study (month 6) compared with RIS-treated (19.9%) and HAL-treated (44.0%) patients (P < 0.001). The mean daily doses recorded in this analysis based on data from a naturalistic setting are consistent with recommendations based on clinical trials. Compared with both RIS- and HAL-treated patients, OLZ-treated patients were less likely to experience EPS or other adverse events, and less likely to use concomitant anticholinergic medications. OLZ-treated patients were also more likely to respond to treatment than were RIS-treated patients.

  5. Tianeptine, olanzapine and fluoxetine show similar restoring effects on stress induced molecular changes in mice brain: An FT-IR study

    Türker-Kaya, Sevgi; Mutlu, Oğuz; Çelikyurt, İpek K.; Akar, Furuzan; Ulak, Güner


    Chronic stress which can cause a variety of disorders and illness ranging from metabolic and cardiovascular to mental leads to alterations in content, structure and dynamics of biomolecules in brain. The determination of stress-induced changes along with the effects of antidepressant treatment on these parameters might bring about more effective therapeutic strategies. In the present study, we investigated unpredictable chronic mild stress (UCMS)-induced changes in biomolecules in mouse brain and the restoring effects of tianeptine (TIA), olanzapine (OLZ) and fluoxetine (FLX) on these variations, by Fourier transform infrared (FT-IR) spectroscopy. The results revealed that chronic stress causes different membrane packing and an increase in lipid peroxidation, membrane fluidity. A significant increment for lipid/protein, Cdbnd O/lipid, CH3/lipid, CH2/lipid, PO-2/lipid, COO-/lipid and RNA/protein ratios but a significant decrease for lipid/protein ratios were also obtained. Additionally, altered protein secondary structure components were estimated, such as increment in random coils and beta structures. The administration of TIA, OLZ and FLX drugs restored these stress-induced variations except for alterations in protein structure and RNA/protein ratio. This may suggest that these drugs have similar restoring effects on the consequences of stress activity in brain, in spite of the differences in their action mechanisms. All findings might have importance in understanding molecular mechanisms underlying chronic stress and contribute to studies aimed for drug development.

  6. Olanzapine versus typical neuroleptics for schizophrenia: evaluation of social and economic costs

    Giorgio Mariani


    Full Text Available An important number of publications is reporting results from health outcomes studies comparing atypical antipsychotics (AA with typical neuroleptics (TN over 1 year of observation. Our study has prolonged the period observation of the economical and social outcomes to 4 years: 31 patients with schizophrenia were observed retrospectively during two years of TN treatment and then followed during 2 more years of olanzapine treatment after naturalistic switch. The results show a general reduction of health care interventions (territory and hospital during the olanzapine treatment period. Global costs during olanzapine treatment were lower than during TN treatment (10506 euros with TN vs 6193 euros with olanzapine over 2 years. The social outcome, measured through the registration of the number of working days in the two periods of the study (retrospective with TN and prospective with olanzapine, was better during olanzapine treatment, probably due to increased patient compliance to the rehabilitative activities offered by the Department of Mental Health. In our experience, olanzapine appeared to dominate TN treatment, as its higher acquisition costs were offset by the reduction of territorial and nosocomial health care interventions over two years of observation, and associated with higher involvement in rehabilitative and social activities.

  7. Emphysematous pancreatitis predisposed by Olanzapine

    Sukhen Samanta


    Full Text Available A 32-year-old male presented to our intensive care unit with severe abdominal pain and was diagnosed as acute pancreatitis after 2 months of olanzapine therapy for bipolar disorder. His serum lipase was 900 u/L, serum triglyceride 560 mg/dL, and blood sugar, fasting and postprandial were 230 and 478 mg/dL, respectively on admission. Contrast enhanced computed tomography (CECT of abdomen was suggestive of acute pancreatitis. Repeat CECT showed gas inside pancreas and collection in peripancreatic area and patient underwent percutaneous drainage and antibiotics irrigation through the drain into pancreas. We describe the rare case of emphysematous pancreatitis due to development of diabetes, hypertriglyceridemia and immunosuppression predisposed by short duration olanzapine therapy.

  8. Metabolic effects of Olanzapine versus Iloperidone: A 24 weeks ...

    Atypical antipsychotics have become the mainstay of therapy for psychosis. Though extrapyramidal side effects have been reduced with atypical antipsychotics, yet there are increased concerns over metabolic effects. The present study is aimed to comparatively evaluate the metabolic profile of olanzapine and iloperidone ...

  9. Effects of switching from olanzapine to aripiprazole on the metabolic profiles of patients with schizophrenia and metabolic syndrome: a double-blind, randomized, open-label study [Corrigendum

    Wani RA


    Full Text Available Wani RA, Dar MA, Chandel RK, et al Title of paper should have been “Effects of switching from olanzapine to aripiprazole on the metabolic profiles of patients with schizophrenia and metabolic syndrome: a randomized, open-label study”.  Read the original paper 

  10. The Effect of Ranitidine on Olanzapine-Induced Weight Gain

    Fatemeh Ranjbar


    Full Text Available Induced weight gain is a disturbing side effect of Olanzapine that affects the quality of life in psychotic patients. The aim of this study was to assess the efficacy of Ranitidine in attenuating or preventing Olanzapine-induced weight gain. A parallel 2-arm clinical trial was done on 52 patients with schizophrenia, schizoaffective and schizophreniform disorders who received Olanzapine for the first time. All these were first-episode admitted patients. They were randomly allocated to receive either Ranitidine or placebo. The trend of body mass index (BMI was compared between groups over 16-week course of treatment. Mean weight was 62.3 (SD: 9.6 kg at baseline. Thirty-three subjects (63.5% had positive family history of obesity. The average BMI increment was 1.1 for Ranitidine group and 2.4 for the placebo group. The multivariate analysis showed this effect to be independent of sex, family history of obesity, and baseline BMI value. The longitudinal modeling after controlling for baseline values failed to show the whole trend slope to be different. Although the slight change in trend’s slope puts forward a hypothesis that combined use of Ranitidine and Olanzapine may attenuate the weight gain long run, this needs to be retested in future larger scale long-term studies. This trial is registered with 201009112181N5.

  11. Pilot plant study

    Morris, M.E.


    Sandia Laboratories undertook the design and fabrication of an 8 ton/day dry sewage sludge irradiatior. The facility is intended (1) to function as a high-gamma-dose rate research facility; (2) to be a testbed for the unique electrical and mechanical components to be used in larger facilities; (3) to fulfill the formal requirements of a pilot plant so that design and construction of a demonstration facility could proceed; and (4) to provide accurate data base on construction and operating experience for the Environmental Impact Assessment (EIA), the Safety Analysis Report (SAR), and the cost analyses for a larger facility. The facility and its component systems are described in detail

  12. A randomized, double-blind, placebo-controlled proof of concept study to evaluate samidorphan in the prevention of olanzapine-induced weight gain in healthy volunteers.

    Silverman, Bernard L; Martin, William; Memisoglu, Asli; DiPetrillo, Lauren; Correll, Christoph U; Kane, John M


    Antipsychotic medications are associated with weight gain and adverse metabolic effects that complicate the treatment and management of schizophrenia. Olanzapine (OLZ) in particular is associated with significant weight gain and adverse metabolic effects. The present Phase 1, proof of concept, multicenter, randomized, double-blind, placebo-controlled study investigated the safety and effect on weight of a combination of OLZ (10mg) and the opioid modulator samidorphan (SAM; 5mg) in comparison to OLZ alone in healthy, male normal weight volunteers. Altogether, 106 male subjects with stable body weight and BMI 18-25kg/m 2 were randomized to OLZ alone, OLZ+SAM, SAM alone, or placebo in a 2:2:1:1 ratio. The primary efficacy endpoint, mean (SD) body weight change from baseline to last assessment in the 3-week treatment period, was significantly less for OLZ+SAM vs. OLZ alone subjects [+2.2 (1.4) kg vs. +3.1 (1.9) kg; respectively; p=0.02]. In contrast, there was no significant difference in weight from baseline for either SAM or placebo [+0.1 (1.0) kg and +0.8 (1.4) kg, respectively]; p=0.09. Overall, OLZ+SAM compared to OLZ alone had similar safety and tolerability. In addition, less nausea was observed in subjects given OLZ+SAM compared to SAM alone. Thus, OLZ+SAM may offer effective treatment of schizophrenia with less weight gain and metabolic risk. Additional research exploring additional doses over longer durations in psychiatric populations is warranted. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

  13. Differential weight restoration on olanzapine versus fluoxetine in identical twins with anorexia nervosa

    Duvvuri, V; Cromley, T; Klabunde, M; Boutelle, K; Kaye, WH


    Objective: No studies have compared the response to selective serotonin reuptake inhibitors and atypical antipsychotics in anorexia nervosa. This case study examines such a comparison. Method: This report describes a case of 12-year-old identical twins with anorexia nervosa, one of whom was treated with olanzapine and the other with fluoxetine, while undergoing family therapy. Results: Twin A treated with fluoxetine went from 75 to 84.4% ideal body weight, while Twin B treated with olanzapine...

  14. Olanzapine-induced ischemic colitis

    Esteban Sáez-González

    Full Text Available Background: Ischemic colitis (IC is an uncommon adverse event associated with antipsychotic agents, more commonly found with phenothiazine drugs and atypical neuroleptics such as clozapine. The risk of developing ischemic colitis increases when anticholinergic drugs are associated. Case report: We report the case of a 38-year-old woman with a history of schizoaffective disorder who had been on chronic quetiapine for 3 years, and presented to the ER because of diarrhea for 5 days. Four months previously, olanzapine had been added to her psychiatric drug regimen. Physical examination revealed abdominal distension with abdominal tympanic sounds and tenderness. Emergency laboratory tests were notable for increased acute phase reagents. Tomography revealed a concentric thickening of the colonic wall in the transverse, descending and sigmoid segments, with no signs of intestinal perforation. Colonoscopy demonstrated severe mucosal involvement from the sigmoid to the hepatic flexure, with ulcerations and fibrinoid exudate. Biopsies confirmed the diagnosis of ischemic colitis. The only relevant finding in her history was the newly added drug to her baseline regimen. An adverse effect was suspected because of its anticholinergic action at the intestinal level, and the drug was withdrawn. After 6 months of follow-up clinical, laboratory and endoscopic recovery was achieved. Discussion: Antipsychotic medication should be considered as a potential cause of ischemic colitis, particularly atypical antipsychotics such as clozapine and olanzapine; despite being uncommon, this adverse event may result in high morbidity and mortality.

  15. Olanzapine is effective for refractory chemotherapy-induced nausea and vomiting irrespective of chemotherapy emetogenicity.

    Vig, Sierra; Seibert, Laurel; Green, Myke R


    The role of olanzapine added to a dopamine antagonist and benzodiazepine for the treatment of refractory chemotherapy-induced nausea and vomiting (CINV) is incompletely characterized in all levels of chemotherapy emetogenicity. This retrospective study evaluated the efficacy of the addition of olanzapine in adults experiencing refractory CINV stratified by chemotherapy emetogenicity. Thirty-three adults who experienced CINV refractory to guideline-recommended prophylaxis and breakthrough antiemetics (dopamine antagonists and benzodiazepines) and received at least one dose of olanzapine 5-10 mg per os were evaluated. Failure was defined as >5 emesis events in 24 h or more than 10 cumulative doses of rescue antiemetics following first olanzapine dose per treatment cycle. Post hoc analyses investigated variables impacting olanzapine efficacy. The addition of olanzapine demonstrated an overall success rate of 70 %. This success rate did not differ between chemotherapy regimens of high versus low-to-moderate emetogenicity (p = 0.79), prophylaxis with serotonin antagonist plus corticosteroid and aprepitant versus serotonin antagonist alone (p = 0.77), or age over 50 versus ≤50 years (p > 0.99). A trend toward greater benefit was seen in women (p = 0.08). The addition of olanzapine to a dopamine antagonist and benzodiazepine demonstrated high efficacy rates for refractory CINV irrespective of chemotherapy emetogenicity. The high success rates among all groups suggests that incomplete resolution of CINV with prophylactic serotonin antagonists and breakthrough dopamine antagonists plus benzodiazepine may benefit from the addition of olanzapine regardless of gender, degree of chemotherapy emetogenicity, number of prophylactic antiemetics, or age. The trend toward greater control of emesis in women merits further investigation.

  16. Efficacy of olanzapine long-acting injection in patients with acutely exacerbated schizophrenia: an insight from effect size comparison with historical oral data

    Detke Holland C


    Full Text Available Abstract Background To treat acute schizophrenia, a long-acting injectable antipsychotic needs a rapid onset of action and therapeutic profile similar to that of oral agents. The present post-hoc analyses compared results from a randomized, double-blind, placebo-controlled trial of olanzapine long-acting injection (LAI for acute schizophrenia with those observed in similarly designed trials of oral olanzapine. Methods Six-week results from the olanzapine LAI study (N = 404 were compared with those of 3 oral studies (study 1: olanzapine vs. haloperidol vs. placebo [N = 335]; study 2: olanzapine vs. haloperidol vs. low-dose olanzapine [N = 431]; study 3: olanzapine vs. placebo vs. low-dose olanzapine [N = 152]. All patients had baseline Brief Psychiatric Rating Scale (BPRS scores ≥24 (0–6 scale. Six-week effect sizes were calculated. Efficacy onset, pharmacokinetics, discontinuations, weight gain, and extrapyramidal symptoms were also assessed. Results At 6 weeks, mean BPRS scores decreased by 14 to 15 points for olanzapine LAI (405 mg/4 weeks, 210 or 300 mg/2 weeks, by 8 to 16 for oral olanzapine (10 ± 2.5 or 15 ± 2.5 mg/day, and by 12 to 13 for haloperidol (15 ± 5 mg/day. For those same dose groups, effect sizes vs. placebo for the BPRS were 0.7 to 0.8 for olanzapine LAI, 0.5 to 0.7 for oral olanzapine, and 0.6 for haloperidol. The first statistically significant separation from placebo on the BPRS occurred at 3 days for the olanzapine LAI groups and at 1 week for oral olanzapine and haloperidol (15 ± 5 mg/day in oral study 1 although as late as week 6 for the 10-mg/day olanzapine dose in oral study 3. Olanzapine concentrations were similar across studies. Weight gain ≥7% of baseline occurred in up to 35% of olanzapine LAI and oral patients versus up to 12% of haloperidol and placebo patients. Extrapyramidal symptoms were lowest in the olanzapine LAI groups and significantly greater

  17. Long-term weight loss observed with olanzapine orally disintegrating tablets in overweight patients with chronic schizophrenia. A 1 year open-label, prospective trial.

    Chawla, Bharat; Luxton-Andrew, Heather


    To investigate the long-term weight loss outcomes during usual clinical practice after switching from olanzapine standard oral tablet (SOT) to olanzapine orally disintegrating tablets (ODT). In this open-label prospective study, 26 patients with schizophrenia who were clinically stable on olanzapine SOT treatment were switched to olanzapine ODT. All other aspects of treatment remained constant. Weight was recorded at 3, 6, and 12 months. Patients incurred an average weight loss of 2.7 +/- 0.7 kg (p = 0.001) after switching patients from olanzapine SOT to olanzapine ODT at 12 months. Peak weight loss was observed at 6 months; however, significant weight loss was achieved as early as 3 months. The majority (81.9%) of patients lost weight, while 18.1% had no weight change or weight gain. Body mass index (BMI) significantly decreased by 1.0 +/- 0.3 kg/m(2) (p = 0.001). Interestingly, patients treated with higher doses of olanzapine (> or = 20 mg) incurred a greater weight loss of their body weight (5.6%), compared to those treated with lower doses (< 20 mg), who lost 1.9% of their body weight (p = 0.04). This study demonstrated that, in usual clinical practice, switching patients from olanzapine SOT to olanzapine ODT treatment resulted in significant weight loss that was maintained over 12 months. 2008 John Wiley & Sons, Ltd.

  18. Speech Alarms Pilot Study

    Sandor, A.; Moses, H. R.


    Currently on the International Space Station (ISS) and other space vehicles Caution & Warning (C&W) alerts are represented with various auditory tones that correspond to the type of event. This system relies on the crew's ability to remember what each tone represents in a high stress, high workload environment when responding to the alert. Furthermore, crew receive a year or more in advance of the mission that makes remembering the semantic meaning of the alerts more difficult. The current system works for missions conducted close to Earth where ground operators can assist as needed. On long duration missions, however, they will need to work off-nominal events autonomously. There is evidence that speech alarms may be easier and faster to recognize, especially during an off-nominal event. The Information Presentation Directed Research Project (FY07-FY09) funded by the Human Research Program included several studies investigating C&W alerts. The studies evaluated tone alerts currently in use with NASA flight deck displays along with candidate speech alerts. A follow-on study used four types of speech alerts to investigate how quickly various types of auditory alerts with and without a speech component - either at the beginning or at the end of the tone - can be identified. Even though crew were familiar with the tone alert from training or direct mission experience, alerts starting with a speech component were identified faster than alerts starting with a tone. The current study replicated the results from the previous study in a more rigorous experimental design to determine if the candidate speech alarms are ready for transition to operations or if more research is needed. Four types of alarms (caution, warning, fire, and depressurization) were presented to participants in both tone and speech formats in laboratory settings and later in the Human Exploration Research Analog (HERA). In the laboratory study, the alerts were presented by software and participants were

  19. Speech Alarms Pilot Study

    Sandor, Aniko; Moses, Haifa


    Speech alarms have been used extensively in aviation and included in International Building Codes (IBC) and National Fire Protection Association's (NFPA) Life Safety Code. However, they have not been implemented on space vehicles. Previous studies conducted at NASA JSC showed that speech alarms lead to faster identification and higher accuracy. This research evaluated updated speech and tone alerts in a laboratory environment and in the Human Exploration Research Analog (HERA) in a realistic setup.

  20. Olanzapine versus haloperidol: Which can control stuttering better?

    Vahid Shaygannejad


    Conclusions: It seems that olanzapine does have better impact in controlling stuttering, and it may be recommended to prescribe olanzapine for stutters as the first choice to control the stuttering under a careful follow-up.

  1. Alterations to melanocortinergic, GABAergic and cannabinoid neurotransmission associated with olanzapine-induced weight gain.

    Katrina Weston-Green

    Full Text Available BACKGROUND/AIM: Second generation antipsychotics (SGAs are used to treat schizophrenia but can cause serious metabolic side-effects, such as obesity and diabetes. This study examined the effects of low to high doses of olanzapine on appetite/metabolic regulatory signals in the hypothalamus and brainstem to elucidate the mechanisms underlying olanzapine-induced obesity. METHODOLOGY/RESULTS: Levels of pro-opiomelanocortin (POMC, neuropeptide Y (NPY and glutamic acid decarboxylase (GAD(65, enzyme for GABA synthesis mRNA expression, and cannabinoid CB1 receptor (CB1R binding density (using [(3H]SR-141716A were examined in the arcuate nucleus (Arc and dorsal vagal complex (DVC of female Sprague Dawley rats following 0.25, 0.5, 1.0 or 2.0 mg/kg olanzapine or vehicle (3×/day, 14-days. Consistent with its weight gain liability, olanzapine significantly decreased anorexigenic POMC and increased orexigenic NPY mRNA expression in a dose-sensitive manner in the Arc. GAD(65 mRNA expression increased and CB1R binding density decreased in the Arc and DVC. Alterations to neurotransmission signals in the brain significantly correlated with body weight and adiposity. The minimum dosage threshold required to induce weight gain in the rat was 0.5 mg/kg olanzapine. CONCLUSIONS: Olanzapine-induced weight gain is associated with reduced appetite-inhibiting POMC and increased NPY. This study also supports a role for the CB1R and GABA in the mechanisms underlying weight gain side-effects, possibly by altering POMC transmission. Metabolic dysfunction can be modelled in the female rat using low, clinically-comparable olanzapine doses when administered in-line with the half-life of the drug.

  2. Short-term treatment with olanzapine does not modulate gut hormone secretion: olanzapine disintegrating versus standard tablets

    Vidarsdottir, Solrun; Roelfsema, Ferdinand; Streefland, Trea


    BACKGROUND: Treatment with olanzapine (atypical antipsychotic drug) is frequently associated with various metabolic anomalies, including obesity, dyslipidemia, and diabetes mellitus. Recent data suggest that olanzapine orally disintegrating tablets (ODT), which dissolve instantaneously in the mouth...

  3. Long-term administration of olanzapine induces adiposity and increases hepatic fatty acid desaturation protein in female C57BL/6J mice

    Hou, Po-Hsun; Chang, Geng-Ruei; Chen, Chin-Pin; Lin, Yen-Ling; Chao, I-Shuan; Shen, Ting-Ting; Mao, Frank Chiahung


    Objective(s): Weight gain and metabolic disturbances such as dyslipidemia, are frequent side effects of second-generation antipsychotics, including olanzapine. This study examined the metabolic effects of chronic olanzapine exposure. In addition, we investigated the hepatic fatty acid effects of olanzapine in female C57BL/6J mice fed a normal diet. Materials and Methods: Female C57BL/6J mice orally received olanzapine or normal saline for 7 weeks. The effects of long-term olanzapine exposure on body weight changes, food efficiency, blood glucose, triglyceride (TG), insulin, and leptin levels were observed. Hepatic TG and abdominal fat mass were investigated, and fat cell morphology was analyzed through histopathological methods. The levels of protein markers of fatty acid regulation in the liver, namely fatty acid synthase (FAS) and stearoyl-CoA desaturase-1 (SCD-1), were measured. Results: Olanzapine treatment increased the food intake of the mice as well as their body weight. Biochemical analyses showed that olanzapine increased blood TG, insulin, leptin, and hepatic TG. The olanzapine group exhibited increased abdominal fat mass and fat cell enlargement in abdominal fat tissue. Western blotting of the mouse liver revealed significantly higher (1.6-fold) levels of SCD-1 in the olanzapine group relative to the control group; by contrast, FAS levels in the two groups did not differ significantly. Conclusion: Enhanced lipogenesis triggered by increased hepatic SCD-1 activity might be a probable peripheral mechanism of olanzapine-induced dyslipidemia. Some adverse metabolic effects of olanzapine may be related to the disturbance of lipid homeostasis in the liver. PMID:29922430

  4. 90% Compliance Pilot Studies Final Report



    In early 2010, the U.S. Department of Energy (DOE) announced an opportunity for states to participate in energy code compliance evaluation pilot studies. DOE worked with five Regional Energy Efficiency Organizations (REEOs, formerly referred to as Energy Efficiency Partnerships, or EEPs) to fund pilot studies covering nine states. This report details conclusions stated in individual state reports, as well as conclusions drawn by DOE based on their oversight of the pilot studies, and based on discussions held with the REEOs and representatives from the pilot study states and their contractors.

  5. Effectiveness and safety of oral olanzapine treatment transitioned from rapid-acting intramuscular olanzapine for agitation associated with schizophrenia

    Katagiri H


    Full Text Available Hideaki Katagiri,1 Masanori Taketsuna,2 Shinpei Kondo,3 Kenta Kajimoto,4 Etsuko Aoi,5 Yuka Tanji1 1Bio-Medicines, Medicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan; 2Statistical Sciences, Medicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan; 3Post Marketing Study Management, Medicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan; 4Scientific Communications, Medicines Development Unit Japan, Eli Lilly Japan K.K., Kobe, Japan; 5Global Patient Safety Japan, Quality and Patient Safety, Eli Lilly Japan K.K., Kobe, Japan Objective: To assess the effectiveness and safety of oral olanzapine treatment transitioned from rapid-acting intramuscular olanzapine (RAIM in patients with acute agitation associated with schizophrenia in a real-world clinical setting. Methods: The postmarketing surveillance study with a 3-day observational period after the last RAIM administration was conducted (original study. Following this, an extended study was added for patients who received oral olanzapine after RAIM administration during the original study period, in order to additionally observe them for 7 days after initial RAIM administration. Effectiveness and safety from initial RAIM administration were evaluated using the Positive and Negative Syndrome Scale-Excited Component score and treatment-emergent adverse events (TEAEs, respectively. Results: The effectiveness and safety analysis set included a total of 521 and 522 patients, respectively. A majority of patients received 10 mg of RAIM (475/522 patients, 91.0%. The mean ± SD total Positive and Negative Syndrome Scale-Excited Component score was 23.6±6.2 (n=318 at baseline (before initial RAIM administration, 17.4±6.8 (n=280 at 2 hours after initial administration, 16.2±6.8 (n=246 2 days after final administration, 14.9±6.2 (n=248 3 days after final administration, 13.8±5.9 (n=242 4 days after final administration, 13.2±5.8 (n=221 7 days after initial

  6. Orally disintegrating olanzapine review: effectiveness, patient preference, adherence, and other properties

    Montgomery W


    Full Text Available William Montgomery1, Tamas Treuer2, Jamie Karagianis3, Haya Ascher-Svanum4, Gavan Harrison51Global Health Outcomes, Eli Lilly and Company, Sydney, Australia; 2Emerging Markets Business Unit (Neuroscience, Eli Lilly and Company, Budapest, Hungary; 3Eli Lilly and Company, Indianapolis, IN, USA; 4Global Health Outcomes, Eli Lilly and Company, Indianapolis, IN, USA; 5Asia-Pacific Medical Communications, Eli Lilly and Company, Sydney, AustraliaAbstract: Orally disintegrating olanzapine (ODO is a rapid-dissolving formulation of olanzapine which disintegrates in saliva almost immediately, developed as a convenient and adherence-enhancing alternative to the standard olanzapine-coated tablet (SOT. Clinical studies, which form the basis of this review, have shown ODO and SOT to have similar efficacy and tolerability profiles. However, ODO appears to have a number of advantages over SOT in terms of adherence, patient preference, and reduction in nursing burden. Overall, the existing clinical data suggests that compared to SOT, ODO is not only well-suited for difficult-to-treat, agitated, and/or nonadherent patients but, due to its potential ability to improve adherence and greater patient preference, may also be an appropriate formulation for the majority of patients for which olanzapine is the antipsychotic of choice.Keywords: orodispersible formulation, orally disintegrating, olanzapine, atypical antipsychotics, patient adherence, preference, schizophrenia, bipolar disorder

  7. IVIVC from Long Acting Olanzapine Microspheres

    Susan D'Souza


    Full Text Available In this study, four PLGA microsphere formulations of Olanzapine were characterized on the basis of their in vitro behavior at 37°C, using a dialysis based method, with the goal of obtaining an IVIVC. In vivo profiles were determined by deconvolution (Nelson-Wagner method and using fractional AUC. The in vitro and in vivo release profiles exhibited the same rank order of drug release. Further, in vivo profiles obtained with both approaches were nearly superimposable, suggesting that fractional AUC could be used as an alternative to the Nelson-Wagner method. A comparison of drug release profiles for the four formulations revealed that the in vitro profile lagged slightly behind in vivo release, but the results were not statistically significant (P0.96 between in vitro release and in vivo measurements confirmed the excellent relationship between in vitro drug release and the amount of drug absorbed in vivo. The results of this study suggest that proper selection of an in vitro method will greatly aid in establishing a Level A IVIVC for long acting injectables.

  8. Differential weight restoration on olanzapine versus fluoxetine in identical twins with anorexia nervosa.

    Duvvuri, Vikas; Cromley, Taya; Klabunde, Megan; Boutelle, Kerri; Kaye, Walter H


    No studies have compared the response to selective serotonin reuptake inhibitors and atypical antipsychotics in anorexia nervosa. This case study examines such a comparison. This report describes a case of 12-year-old identical twins with anorexia nervosa, one of whom was treated with olanzapine and the other with fluoxetine, while undergoing family therapy. Twin A treated with fluoxetine went from 75 to 84.4% ideal body weight, while Twin B treated with olanzapine went from 72 to 99.9% ideal body weight over the course of 9 months. This case supports the need for adequately powered, controlled clinical trials to test the efficacy of olanzapine in adolescents presenting with anorexia nervosa. Copyright © 2011 Wiley Periodicals, Inc.

  9. Liverpool Telecare Pilot: case studies

    Nigel Barnes


    Full Text Available Telecare services use information and communications technology (ICT to support the provision of care to people in their own homes. This paper describes a pilot telecare service employed by Liverpool (UK City Council to support a sample of their frail and elderly social services users. The pilot has been running for over two years and has been deployed for 21 individuals in Liverpool. In this paper we present the pilot system and provide real example cases which help to illustrate the benefits of such a system.

  10. Eosinophilic myocarditis during treatment with olanzapine

    Vang, Torkel; Rosenzweig, Mary; Bruhn, Christina Hedegaard


    -mortem toxicological examination demonstrated presence of olanzapine, morphine, venlafaxine and oxazepam. Syringes indicating substance abuse were found in his home. Case 2 was a 36-year-old Caucasian man diagnosed with schizophrenia was found dead unexpectedly. There was no history of substance abuse. Current...

  11. Olanzapine induced biochemical and histopathological changes after its chronic administration in rats

    Rehmat Shah


    Full Text Available Objective: Olanzapine is a second generation antipsychotic acting mainly as a dopamine D2 and serotonine 5-HT2 receptors antagonist prescribed in the treatment of schizophrenia and various other psychiatric illnesses. Even though olanzapine is widely used in psychiatry, its effects on the architecture of pancreas, liver and kidneys are little known. The histology of pancreas especially has never been studied. For these reasons, the current study was designed to elucidate the toxic effects of chronic administration of olanzapine on pancreas, liver and kidneys and the enzymes released by these tissues in an escalating dose manner. Methods: Fourteen male rats were divided into two groups equally, the olanzapine group and the controls. Olanzapine was administered in a dose of 5 mg/kg/d for the first eight weeks, 10 mg/kg/d for next four weeks and 15 mg/kg/d through the last two week period of 14 weeks experiment. The controls received acidified saline only. Both the groups received restricted diet (20 g/12 h. The body weight and level of random blood sugar (RBS were measured on a weekly basis. The levels of lipase, amylase, alanine transaminase (ALT and aspartate transaminase (AST were determined terminally. At the end of the experiment, the tissues were dissected out for histopathological evaluation. Results: Significant loss in body weight, change in the level of random blood sugar (∗∗P  0.05. The pancreas has shown derangement of beta cells and fibrotic growth. A mild to moderate focal increase in glomerular cellularity, cellular proliferation and glomerular capsules with negligible basement membranes were observed in the kidneys. No changes were observed in the architecture of the liver. Conclusion: The findings of this study indicated that the incidence of adverse effects associated with olanzapine could be prevented/alleviated/delayed by allowing restricted diet.

  12. Olanzapine Overdose in a Pin Point Pupil with Altered Sensorium

    Naresh Midha


    Full Text Available Background:Olanzapine is a highly tolerable and easily affordable atypical antipsychotic drug which has been commonly prescribed in both inpatient and outpatient settings for several mental disorders. Olanzapine overdose is commonly seen in psychiatric patients, who attempt suicide by intoxicating themselves with their own prescribed medications. Increased olanzapine use is associated with increased incidence of overdosing. Case Presentation:We are reporting a case of olanzapine overdosage as a cause of pinpoint pupils and altered sensorium with exclusion of other differentials. The mainstay of managementof olanzapine overdose is general supportive and symptomatic measures. Discussion: Pinpoint pupils with altered sensorium and agitation are always an alarming situation for a clinician, because of differentials like organophosphorus poisoning, pontine hemorrhage and opium overdosing. Due to olanzapine overdosage, similar clinical picture can be confusing in the emergency department and early identification of such cases is helpful to decrease the risk of fatality. Conclusion: This case highlights the significance of olanzapine overdosing as a differential diagnosis for patients presented with altered sensorium and pinpoint pupils in the emergency department. Olanzapine overdosage is associated with high morbidity and mortality. Although there is no specific antidote for olanzapine overdose, appropriate history, assessment and early diagnosis are very useful for the better outcome.

  13. How can lipid nanocarriers improve transdermal delivery of olanzapine?

    Iqbal, Nimra; Vitorino, Carla; Taylor, Kevin M G


    The development of a transdermal nanocarrier drug delivery system with potential for the treatment of psychiatric disorders, such as schizophrenia and bipolar disorder, is described. Lipid nanocarriers (LN), encompassing various solid:liquid lipid compositions were formulated and assessed as potential nanosystems for transdermal delivery of olanzapine. A previously optimized method of hot high pressure homogenization (HPH) was adopted for the production of the LN, which comprised solid lipid nanoparticles (SLN), nanostructured lipid carriers (NLC) and nanoemulsions (NE). Precirol  ® was selected as the solid lipid for progression of studies. SLN exhibited the best performance for transdermal delivery of olanzapine, based on in vitro release and permeation studies, coupled with results from physicochemical characterization of several solid:liquid lipid formulations. Stability tests, performed to give an indication of long-term storage behavior of the formulations, were in good agreement with previous studies for the best choice of solid:liquid lipid ratio. Overall, these findings highlight the SLN-based formulation as promising for the further inclusion in and production of transdermal patches, representing an innovative therapeutic approach.

  14. Electrocoagulation project: Pilot study testwork

    Donini, J.C.; Garand, D.K.; Hassan, T.A.; Kar, K.L.; Thind, S.S.


    When a suspension or emulsion flows between two sacrificial metal electrodes excited by ac, the dispersed phase is consolidated and then settles. Laboratory-scale investigation of this mechanism, called electrocoagulation, and of its areas of application to water treatment were previously completed and a subsequent project was initiated to design and construct pilot-scale equipment consisting of an electrocoagulation cell, power supply, and computerized control system. The constructed pilot plant was used to test the effectiveness of electrocoagulation to clarify coal processing plant effluent. Results obtained with clay suspensions showed that flow conditions in the cell have a major effect on electric power consumption, and a reduction by a factor of three on this crucial cost parameter appeared possible compared to a previously tested batch-scale electrocoagulation system. Results obtained using the coal plant thickener feed closely duplicated those obtained with the clay mixtures. Aluminum electrode consumption, however, remained unchanged compared to the bench-scale tests. Supernatant clarity far exceeded requirements, while settling rate was too low. The settling could be speeded up by appropriate use of chemicals, but such addition affects the coagulation mechanism and reduces supernatant clarity. A tradeoff between settling rate and clarity was thus established. The total cost of treatment was deemed to be in excess of coal company requirements, but the pilot tests revealed much about the electrocoagulation system under continuous flow conditions. The technology is seen as having application in other areas such as municipal and industrial waste treatment. 22 refs., 6 figs., 2 tabs.

  15. Olanzapine-Induced Neuroleptic Malignant Syndrome

    Seyedhamze Hosseini


    Full Text Available Neuroleptic malignant syndrome (NMS is a rare but life-threatening idiosyncratic side effect resulting from neuroleptic drugs. NMS mainly occurs in patients treated with high-potency typical antipsychotics, but rarely caused by atypical antipsychotics. Although NMS is less common with atypical antipsychotic, but it seems that its incidence is rising due to increased administration of such drugs. We present the case of a 27-year-old man with a history of paranoid schizophrenia that showed signs consistent with NMS that occurred after treatment with olanzapine. The patient was adherent to treatment. He had decreased level of consciousness, muscle rigidity, diaphoresis, fever, drooling, urinary incontinence, and high blood pressure. This patient illustrates that NMS can occur due to treatment with atypical antipsychotic drugs like olanzapine, particularly in the presence of risk factors. This phenomenon is often unrecognized, underdiagnosed, or not treated properly. Physicians should be aware that NMS with extrapyramidal syndrome could occur with olanzapine at steady state doses without recent dosage adjustments or titration. It is essential that adequate and safe dose of medication is chosen and the patient is monitored by the signs and symptoms of this lethal syndrome.

  16. Ziprasidone as an adjuvant for clozapine- or olanzapine-associated medical morbidity in chronic schizophrenia

    Henderson, David C.; Fan, Xiaoduo; Copeland, Paul M.; Sharma, Bikash; Borba, Christina P.; Forstbauer, Sharon I.; Miley, Kate; Boxill, Ryan; Freudenreich, Oliver; Cather, Corey; Evins, A. Eden; Goff, Donald C.


    Objective This study sought to examine the effect of ziprasidone on olanzapine or clozapine associated medical morbidity such as insulin resistance, diabetes mellitus and impaired fasting glucose, obesity and hyperlipidemia in patients with schizophrenia or schizoaffective disorder. Method This was a six-week, open label trial of ziprasidone 160 mg/day added to a stable dose of olanzapine or clozapine in twenty-one schizophrenia or schizoaffective patients with diabetes mellitus, impaired fasting glucose, or insulin resistance. Results Ten olanzapine-treated subjects and eleven clozapine-treated subjects were enrolled in the study. There were no significant differences between the two groups at baseline for age, gender, education, ethnicity, BMI, cholesterol levels, or fasting glucose. At week six, there were no significant changes in weight, BMI, cholesterol levels, or fasting glucose. There was no significant difference in psychotic, negative or depressive symptoms. QTc significantly increased at week 2 but not at week 6. Conclusions The addition of 160 mg/day of ziprasidone was well tolerate but did not produce significant improvement in fasting glucose, insulin resistance, hyperlipidemia or lead to weight loss in olanzapine- or clozapine-treated subjects with schizophrenia or schizoaffective disorder. PMID:19283774

  17. Effect of Olanzapine on Clinical and Polysomnography Profiles in Patients with Schizophrenia

    Mohammad Zia Ul Haq Katshu


    Full Text Available Acute and short-term administration of olanzapine has a favorable effect on sleep in schizophrenia patients. This study aimed to clarify the effect of olanzapine on polysomnographic profiles of schizophrenia patients during the acute phase of illness after controlling for previous drug exposure. Twenty-five drug-naïve or drug-free schizophrenia patients were assessed at baseline and after six weeks of olanzapine treatment on Brief Psychiatric Rating Scale (BPRS, Positive and Negative Syndrome Scale (PANSS, and Udvalg for Kliniske Undersogelser (UKU side-effect rating scale and a whole-night polysomnography; fifteen patients completed the study. There was a significant reduction in all psychopathological variables with maximum reduction in PANSS total, BPRS total, and PANSS positive scores. A significant increase in total sleep time (TST, sleep efficiency (SE, nonrapid eye movement (NREM stage 1 duration, stage 3 duration, stage 4 duration, and stage 4 percentage of TST, number of rapid eye movement (REM periods, REM duration, and REM percentage of TST was observed. REM latency at baseline inversely predicted the reduction in BPRS total and PANSS total and positive scores. In summary, short-term treatment with olanzapine produced significant improvement in clinical and polysomnography profiles of patients with schizophrenia with shorter REM latency predicting a good clinical response.

  18. Haloperidol, risperidone, olanzapine and aripiprazole in the management of delirium: A comparison of efficacy, safety, and side effects.

    Boettger, Soenke; Jenewein, Josef; Breitbart, William


    The aim of this study was to compare the efficacy and side-effect profile of the typical antipsychotic haloperidol with that of the atypical antipsychotics risperidone, olanzapine, and aripiprazole in the management of delirium. The Memorial Delirium Assessment Scale (MDAS), the Karnofsky Performance Status (KPS) scale, and a side-effect rating were recorded at baseline (T1), after 2-3 days (T2), and after 4-7 days (T3). Some 21 cases were case-matched by age, preexisting dementia, and baseline MDAS scores, and subsequently analyzed. The baseline characteristics of the medication groups were not different: The mean age of the patients ranged from 64.0 to 69.6 years, dementia was present in between 23.8 and 28.6%, and baseline MDAS scores were 19.9 (haloperidol), 18.6 (risperidone), 19.4 (olanzapine), and 18.0 (aripiprazole). The doses of medication at T3 were 5.5 mg haloperidol, 1.3 mg risperidone, 7.1 mg olanzapine, and 18.3 mg aripiprazole. Over one week, the decline in MDAS scores between medications was equal, and no differences between individual MDAS scores existed at T2 or T3. After one week, the MDAS scores were 6.8 (haloperidol), 7.1 (risperidone), 11.7 (olanzapine), and 8.3 (aripiprazole). At T2, delirium resolution occurred in 42.9-52.4% of cases and at T3 in 61.9-85.7%; no differences in assessments between medications existed. Recorded side effects were extrapyramidal symptoms (EPSs) in haloperidol- and risperidone-managed patients (19 and 4.8%, respectively) and sedation with olanzapine (28.6%). Haloperidol, risperidone, aripiprazole, and olanzapine were equally effective in the management of delirium; however, they differed in terms of their side-effect profile. Extrapyramidal symptoms were most frequently recorded with haloperidol, and sedation occurred most frequently with olanzapine.

  19. Microtitrimetric determination of a drug content of pharmaceuticals containing olanzapine in non-aqueous medium



    Full Text Available Two simple, rapid, reliable and cost-effective methods based on titrimetry in non-aqueous medium are described for the determination of olanzapine in pharmaceuticals. In these methods, the drug dissolved in the glacial acetic acid was titrated with the acetous perchloric acid with visual and potentiometric end point detection, crystal violet being used as the indicator for visual titration. The methods are applicable over 1-15 mg range of olanzapine. The procedures were applied to determine olanzapine in pharmaceutical products and the results were found to be in a good agreement with those obtained by the reference method. Associated pharmaceutical materials did not interfere. The precision results, expressed by inter-day and intra-day relative standard deviation values, were satisfactory, higher than 2%. The accuracy was satisfactory as well. The methods proved to be suitable for the analysis of olanzapine in bulk drug and in tablets. The accuracy and reliability of the methods were further ascertained by recovery studies via a standard addition technique with percent recoveries in the range 97.51-103.7% with a standard deviation of less than 2%.

  20. Olanzapine Reverses MK-801-Induced Cognitive Deficits and Region-Specific Alterations of NMDA Receptor Subunits

    Liu, Xiao; Li, Jitao; Guo, Chunmei; Wang, Hongli; Sun, Yaxin; Wang, Han; Su, Yun-Ai; Li, Keqing; Si, Tianmei


    Cognitive dysfunction constitutes an essential component in schizophrenia for its early presence in the pathophysiology of the disease and close relatedness to life quality of patients. To develop effective treatment of cognitive deficits, it is important to understand their neurobiological causes and to identify potential therapeutic targets. In this study, adopting repeated MK-801 treatment as an animal model of schizophrenia, we investigated whether antipsychotic drugs, olanzapine and haloperidol, can reverse MK-801-induced cognitive deficits and how the reversal processes recruited proteins involved in glutamate neurotransmission in rat medial prefrontal cortex (mPFC) and hippocampus. We found that low-dose chronic MK-801 treatment impaired object-in-context recognition memory and reversal learning in the Morris water maze, leaving reference memory relatively unaffected, and that these cognitive deficits can be partially reversed by olanzapine, not haloperidol, treatment. At the molecular level, chronic MK-801 treatment resulted in the reduction of multiple N-methyl-D-aspartate (NMDA) receptor subunits in rat mPFC and olanzapine, not haloperidol, treatment restored the levels of GluN1 and phosphorylated GluN2B in this region. Taken together, MK-801-induced cognitive deficits may be associated with region-specific changes in NMDA receptor subunits and the reversal of specific NMDA receptor subunits may underlie the cognition-enhancing effects of olanzapine. PMID:29375333

  1. Olanzapine affects locomotor activity and meal size in male rats

    van der Zwaal, Esther M.; Luijendijk, Mieneke C. M.; Evers, Simon S.; la Fleur, Susanne E.; Adan, Roger A. H.


    Olanzapine is an antipsychotic drug that frequently induces weight gain accompanied by increased fat deposition as a side effect To investigate how olanzapine affects different aspects of energy balance we used male rats to determine effects on meal patterns food preference locomotor activity and

  2. Olanzapine affects locomotor activity and meal size in male rats

    van der Zwaal, Esther M.; Luijendijk, Mieneke C. M.; Evers, Simon S.; la Fleur, Susanne E.; Adan, Roger A. H.


    Olanzapine is an antipsychotic drug that frequently induces weight gain accompanied by increased fat deposition as a side effect. To investigate how olanzapine affects different aspects of energy balance, we used male rats to determine effects on meal patterns, food preference, locomotor activity

  3. The ENIQ pilot study: current status

    Lemaitre, P; Eriksen, B; Crutzen, S [European Commission, DG Joint Research Centre, Petten (Netherlands); Hansch, M [Preussische Elektrizitaets-AG (Preussenelektra), Hannover (Germany); Whittle, J [AEA Technology, Warrington (United Kingdom)


    A pilot study is currently being carried out by ENIQ (European Network for Inspection Qualification) in order to explore the issues involved in inspection qualification applied along the general principles of the European methodology. The components selected for the pilot study are austenitic pipe to pipe and pipe to elbows welds typical of those in BWR recirculation loops. A range of defect parameters has been defined. A suitable inspection procedure designed to find the designated defects will be applied to geometrically representative test pieces. The procedure/equipment will be qualified through open trials and technical justification. The personnel qualification will be done in a blind way. Once all features of the inspection system will have been qualified an in-service inspection will be simulated in order to test the feasibility of the qualification approach followed. In this paper the current status of this pilot study is discussed. (orig.)

  4. Fusion pilot plant scoping study

    Gierszewski, P.J.; Blevins, P.J.; Brunnader, H.; Natalizio, A.; Cumyn, P.; Dean, B.; Smith, S.; Galambos, J.; Holloway, C.; Stremlaw, J.; Williams, G.


    CFFTP Pilot is representative of a class of machines that, like NPD in the CANDU development program, could test the key reactor core technologies on an integrated power reactor relevant system (materials, conditions, configuration). But in order to reduce costs, the machine would operate at reduced neutron flux relative to a power reactor, would not produce electricity, and would not test superconducting magnets. This design shows research directions towards a machine that could provide integrated nuclear testing (but not ignition physics) at a cost of about 1/3 ITER CDA. The test volume - the outboard blanket volume - would be comparable to the test port volume on ITER CDA, while the fluence and power density would be about 1/4 ITER CDA. 91 refs., 43 tabs., 45 figs

  5. Fusion pilot plant scoping study

    Gierszewski, P J; Blevins, P J; Brunnader, H; Natalizio, A [Canadian Fusion Fuels Technology Project, Toronto, ON (Canada); Cumyn, P [Canatom Ltd., Montreal, PQ (Canada); Dean, B; Smith, S [Wardrop (W.L.) and Associates Ltd., Winnipeg, MB (Canada); Galambos, J [Oak Ridge National Lab., TN (United States); Holloway, C [Spar Aerospace Ltd., Toronto, ON (Canada); Stremlaw, J [Monenco AGRA Inc., Calgary, AB (Canada); Williams, G [Spectrum Engineering Corp., Peterborough, ON (Canada)


    CFFTP Pilot is representative of a class of machines that, like NPD in the CANDU development program, could test the key reactor core technologies on an integrated power reactor relevant system (materials, conditions, configuration). But in order to reduce costs, the machine would operate at reduced neutron flux relative to a power reactor, would not produce electricity, and would not test superconducting magnets. This design shows research directions towards a machine that could provide integrated nuclear testing (but not ignition physics) at a cost of about 1/3 ITER CDA. The test volume - the outboard blanket volume - would be comparable to the test port volume on ITER CDA, while the fluence and power density would be about 1/4 ITER CDA. 91 refs., 43 tabs., 45 figs.

  6. Pharmaco-epidemiological description of the population of the Marche Region (central Italy treated with the antipsychotic drug olanzapine

    Fiorenzo Mignini


    Full Text Available BACKGROUND. In Italy, even though olanzapine has been discouraged for treatment of behaviour disorders in older patients affected by dementia, some physicians chose to prescribe for them. In response to this situation, the Italian Drug Agency (Agenzia Italiana del Farmaco, AIFA promulgated a cautionary note. MATERIALS AND METHODS. This study examined epidemiological indices for olanzapine prescriptions between 2004 and 2007 in the Marche Region of central Italy and in its provinces, to assess physician compliance with the AIFA note, and to determine whether there were differences in drug prescription between populations of the same territory, or differences based on gender or age group. RESULTS. Our analyses revealed high olanzapine use among young men and mature women, suggesting that these groups are most prone to psychotic symptoms. Analysis revealed that olanzapine prescription in elderly patients was reduced in some provinces, in line with the AIFA note. CONCLUSIONS. Prudent use of olanzapine prescription, in compliance with the AIFA note, was noted throughout the Region. Furthermore, this work offers details that may be useful in future studies of adverse drug reactions.


    The Tampa Asthmatic Children's Study (TACS) was a pilot research study that focused on developing and evaluating air pollution exposure assessment methods and participant recruiting tools for children in the age range of 1-5 years old. The pilot study focused on (a) simple, cost-...

  8. APMP Pilot Study on Transmittance Haze

    Liu, Wen-Chun; Hwang, Jisoo; Koo, Annette; Wu, Houping; Leecharoen, Rojana; Yu, Hsueh-Ling


    Five NMIs within APMP, including CMS/ITRI, MSL, NIM, NIMT and KRISS from TCPR applied to the APMP technical committee initiative project for funding to carry out a pilot comparison of transmittance haze in 2012. The project started in 2014 and the final report was completed at the end of 2016. In this pilot comparison, three different haze standards were adopted, and transmittance haze for each standard was measured according to ASTM D1003 or ISO 14782. This paper presents the first results of an APMP pilot study of transmittance haze and the analysis of the variation among different haze measurement systems which are commonly used. The study shows that the variables such as sphere multiplier, transmittance distribution, fluorescence of samples and optical path of the incident beam cause discrepancies among NMIs and highlight deficiencies in current documentary standards.

  9. Immunosuppressant-Associated Neurotoxicity Responding to Olanzapine

    James A. Bourgeois


    Full Text Available Immunosuppressants, particularly tacrolimus, can induce neurotoxicity in solid organ transplantation cases. A lower clinical threshold to switch from tacrolimus to another immunosuppressant agent has been a common approach to reverse this neurotoxicity. However, immunosuppressant switch may place the graft at risk, and, in some cases, continuation of the same treatment protocol may be necessary. We report a case of immunosuppressant-associated neurotoxicity with prominent neuropsychiatric manifestation and describe psychiatric intervention with olanzapine that led to clinical improvement while continuing tacrolimus maintenance.

  10. Human Challenge Pilot Study with Cyclospora cayetanensis

    Alfano-Sobsey, Edith M.; Eberhard, Mark L.; Seed, John R.; Weber, David J.; Won, Kimberly Y.; Nace, Eva K.; Moe, Christine L.


    We describe a pilot study that attempted to infect human volunteers with Cyclospora cayetanensis. Seven healthy volunteers ingested an inoculum of Cyclospora oocysts (approximately 200–49,000 oocysts). The volunteers did not experience symptoms of gastroenteritis, and no oocysts were detected in any stool samples during the 16 weeks volunteers were monitored.

  11. Comparison of Risperidone and Olanzapine in Bipolar and Schizoaffective Disorders

    Masand, Prakash S.; Wang, Xiaohong; Gupta, Sanjay; Schwartz, Thomas L.; Virk, Subhdeep; Hameed, Ahmad


    Objective: To compare risperidone and olanzapine for efficacy, tolerability, need for concomitant mood stabilizers, and cost of treatment in bipolar and schizoaffective disorders. Method: We conducted a retrospective chart review of 36 consecutive outpatients with DSM-IV bipolar or schizoaffective disorder seen in 3 settings who received risperidone or olanzapine for at least 1 month between May and August 1997. Results: The mean ± SD doses were 3.7 ± 3.5 mg/day of risperidone and 12.0 ± 5.4 mg/day of olanzapine. Between-treatment differences in patient characteristics, psychiatric history, Clinical Global Impressions scale ratings, and duration of treatment were not significant. Similar proportions of patients in the 2 groups reported side effects, including extrapyramidal symptoms, akathisia, tardive dyskinesia, and precipitation of mania by the respective drug. Patients in the olanzapine group received a significantly higher dose of concomitant lithium than those receiving risperidone (mean daily lithium doses: risperidone group, 750 ± 150 mg; olanzapine group, 1211 ± 186 mg; p = .006). The total daily acquisition cost per patient was $11.84 for olanzapine versus $5.81 for risperidone. Conclusion: Olanzapine and risperidone were equally efficacious and safe in the treatment of patients with bipolar or schizoaffective disorder, but treatment costs and dose of concomitant lithium were lower in risperidone-treated patients. PMID:15014747

  12. Olanzapine approved for the acute treatment of schizophrenia or manic/mixed episodes associated with bipolar I disorder in adolescent patients

    Ann E Maloney


    Full Text Available Ann E Maloney1,2, Linmarie Sikich31Maine Medical Center Research Institute, Scarborough, ME, USA; 2Department of Psychiatry, Tufts University School of Medicine, Boston, MA, USA; 3Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USABackground: Severe and persistent mental illnesses in children and adolescents, such as early-onset schizophrenia spectrum (EOSS disorders and pediatric bipolar disorder (pedBP, are increasingly recognized. Few treatments have demonstrated efficacy in rigorous clinical trials. Enduring response to current medications appears limited. Recently, olanzapine was approved for the treatment of adolescents with schizophrenia or acute manic/mixed episodes in pedBP.Methods: PubMed searches were conducted for olanzapine combined with pharmacology, schizophrenia, or bipolar disorder. Searches related to schizophrenia and bipolar disorder were limited to children and adolescents. The bibliographies of the retrieved articles were hand-checked for additional relevant studies. The epidemiology, phenomenology, and treatment of EOSS and pedBP, and olanzapine’s pharmacology are reviewed. Studies of olanzapine treatment in youth with EOSS and pedBP are examined.Results: Olanzapine is efficacious for EOSS and pedBP. However, olanzapine is not more efficacious than risperidone, molindone, or haloperidol in EOSS and is less efficacious than clozapine in treatment-resistant EOSS. No comparative trials have been done in pedBP. Olanzapine is associated with weight gain, dyslipidemia, and transaminase elevations in youth. Extrapyramidal symptoms, neuroleptic malignant syndrome, and blood dyscrasias have also been reported but appear rare.Conclusions: The authors conclude that olanzapine should be considered a second-line agent in EOSS and pedBP due to its risks for significant weight gain and lipid dysregulation. Awareness of the consistent weight and metabolic changes observed in olanzapine

  13. Topiramate for prevention of olanzapine associated weight gain and metabolic dysfunction in schizophrenia: a double-blind, placebo-controlled trial.

    Narula, Preeta Kaur; Rehan, H S; Unni, K E S; Gupta, Neeraj


    Olanzapine associated weight gain (WG) is a major concern in patients with schizophrenia. The purpose of this study was to assess the efficacy of topiramate to prevent olanzapine induced WG in these cases. We also studied various metabolic parameters. In this 12-week, double-blind, parallel group study, seventy-two drug-naïve, first-episode schizophrenia patients were randomized to receive olanzapine+placebo (olanzapine group) or olanzapine+topiramate (100mg/day) (topiramate group). Weight, body mass index, fasting glucose, insulin, insulin resistance (IR), leptin, lipids and blood pressure were assessed at baseline and at 12 weeks. The patients were clinically evaluated using Positive and Negative Syndrome Scale (PANSS) and were monitored for adverse effects. Topiramate resulted in a weight loss of 1.27+/-2.28 kg (pweight gain and adverse metabolic effects. It also results in a greater clinical improvement when used with olanzapine in schizophrenia. Copyright (c) 2010 Elsevier B.V. All rights reserved.

  14. Clinical utility of orally disintegrating olanzapine in Chinese patients with schizophrenia: a review of effectiveness, patient preference, adherence, and other properties

    Zhao J


    Full Text Available Jingping Zhao,1 Jianjun Ou,1 Haibo Xue,2 Li Liu,2 William Montgomery,3 Tamas Treuer4 1Mental Health Institute of The Second Xiangya Hospital, Hunan Province Technology Institute of Psychiatry, Key Laboratory of Psychiatry and Mental Health of Hunan Province, Central South University, Changsha, Hunan, 2Lilly Suzhou Pharmaceutical Co, Ltd, Jiangsu, People's Republic of China; 3Global Health Outcomes, Eli Lilly and Company, Sydney, Australia; 4Emerging Markets Business Unit (Neuroscience, Eli Lilly and Company, Budapest, Hungary Abstract: The primary objective of this systematic review was to examine the evidence for the efficacy, effectiveness, and safety of orally disintegrating olanzapine in Chinese populations. A systematic literature search was conducted using databases covering international and Chinese journals,, and internal and external trial registries at Eli Lilly and Company using search terms related to target countries (People's Republic of China, Hong Kong, and Taiwan and orally disintegrating olanzapine treatment. A publication and one clinical study report were retrieved. The clinical study showed orally disintegrating olanzapine and the standard oral tablet to have similar efficacy and tolerability profiles. A bioequivalence study has shown that orally disintegrating olanzapine and the standard oral tablet have similar pharmacokinetic profiles. Orally disintegrating olanzapine and the standard oral tablet have similar efficacy and tolerability profiles. Keywords: orally disintegrating, olanzapine, Chinese, schizophrenia, patients

  15. Switching to olanzapine long-acting injection from either oral olanzapine or any other antipsychotic: comparative post hoc analyses

    Ciudad A


    Full Text Available Antonio Ciudad,1 Ernie Anand,2 Lovisa Berggren,3 Marta Casillas,4 Alexander Schacht,3 Elena Perrin5 1Department of Clinical Research and Development, Eli Lilly & Co, Madrid, Spain; 2Neuroscience Medical Affairs – EU, Lilly Research Centre, Windlesham, Surrey, UK; 3Global Statistical Sciences, Eli Lilly & Co, Bad Homburg, Germany; 4European Scientific Communications, Eli Lilly & Co, Madrid, Spain; 5Medical Department, Eli Lilly & Co, Suresnes, Paris, France Background: A considerable proportion of patients suffering from schizophrenia show suboptimal responses to oral antipsychotics due to inadequate adherence. Hence, they are likely to benefit from switching to a long-acting injectable formulation. These post hoc analyses assessed the clinical effects of switching to olanzapine long-acting injection (OLAI from either oral olanzapine (OLZ or other antipsychotics (non-OLZ. Methods: Post hoc analyses were done based on two randomized studies (one short-term, one long-term conducted in patients suffering from schizophrenia and treated with OLAI. The short-term study was an 8-week placebo-controlled, double-blind trial in acute patients, and the long-term study was a 2-year, oral olanzapine-controlled, open-label, follow-up of stabilized outpatients. Results: These analyses used data from 62 OLAI-treated patients (12 switched from OLZ, 50 from non-OLZ from the short-term study and 190 OLAI-treated patients (56 switched from OLZ, 134 from non-OLZ from the long-term study. Kaplan–Meier survival analyses of time to all-cause discontinuation of OLAI treatment did not differ significantly between OLZ and non-OLZ patients in the short-term study (P=0.209 or long-term study (P=0.448. Similarly, the proportions of OLZ and non-OLZ patients that discontinued OLAI were not statistically different in the short-term (16.7% versus 36.0%, respectively; P=0.198 or long-term (57.1% versus 47.8% respectively; P=0.238 studies. In the short-term study, no

  16. Intramuscular olanzapine versus intramuscular aripiprazole for the treatment of agitation in patients with schizophrenia: A pragmatic double-blind randomized trial.

    Kittipeerachon, Mantana; Chaichan, Warawat


    To evaluate and compare the effectiveness and adverse effects of intramuscular (IM) olanzapine and IM aripiprazole for the treatment of agitated patients with schizophrenia in clinical practice. A 24-hour randomized double-blind study carried out at a psychiatric hospital in Thailand enrolled adult patients (18-65years old) with schizophrenia experiencing agitation. Patients received one dose of IM olanzapine or IM aripiprazole followed by routine oral psychotropic medications. Efficacy was primarily measured using the Excited Component of the Positive and Negative Syndrome Scale (PANSS-EC). A total of 80 patients with a PANSS-EC score range of 22-35 entered the study, of whom 13% had a medical comorbidity and 40% a history of active substance abuse. The 40 patients receiving IM olanzapine showed greater improvement than the 40 patients receiving IM aripiprazole in PANSS-EC scores at 2h after the injection (p=0.002) but not at 24h. The two treatments were well tolerated. Patients receiving IM olanzapine experienced greater somnolence than those receiving IM aripiprazole. There were no clinically relevant changes in vital signs in either group. The results indicate that IM olanzapine and aripiprazole are similarly effective and well tolerated in the real-world treatment of agitation associated with schizophrenia over the first 24h. However, in the early hours, IM olanzapine may produce more sedation and reductions in agitation. Copyright © 2016 Elsevier B.V. All rights reserved.

  17. Olanzapine and haloperidol for the treatment of acute symptoms of mental disorders induced by amphetamine-type stimulants: A randomized controlled trial.

    Xue, Xiaobin; Song, Yun; Yu, Xiaojie; Fan, Qiang; Tang, Jiyou; Chen, Xu


    This study aimed to compare olanzapine and haloperidol efficacies in the treatment of acute psychiatric symptoms due to amphetamine-type stimulants (ATSs). The Zelen II design method was used; 124 patients with acute mental disorders due to amphetamine were randomly divided into olanzapine group (n = 63) and haloperidol group (n = 61). Then, a 4-week open-label medical therapy was performed. Clinical Global Impression Scale Item 2 was employed to evaluate the onset time; meanwhile, Brief Psychiatric Rating Scale (BPRS) was used at baseline and at posttreatment weeks 1, 2, and 4. Moreover, adverse reactions during the treatment were recorded. Onset time in the olanzapine group was significantly earlier than in the haloperidol group; BPRS scores in the olanzapine group were significantly lower than haloperidol group values at 1 and 2 weeks of treatment. The overall effective rates had no statistically significant difference. Short-term olanzapine and haloperidol treatments had equivalent efficacies in the treatment of acute symptoms of mental disorders due to ATSs; however, olanzapine administration resulted in relatively earlier disease onset, with less adverse reactions.

  18. Effect of olanzapine for breast cancer patients resistant to triplet antiemetic therapy with nausea due to anthracycline-containing adjuvant chemotherapy.

    Sato, Junya; Kashiwaba, Masahiro; Komatsu, Hideaki; Ishida, Kazushige; Nihei, Satoru; Kudo, Kenzo


    Triplet antiemetic therapy with neurokinin 1 receptor blocker, 5-hydroxytryptamine receptor blocker and steroids is commonly used in patients who are highly emetic after chemotherapy. However, an alternative antiemetic therapy for patients who are resistant to triplet antiemetic therapy is not established. Olanzapine is recommended in the guidelines as an optional antiemetic drug. However, the effectiveness of adding olanzapine to triplet antiemetic therapy is unknown. In this study, the effectiveness and safety of adding olanzapine to triplet antiemetic therapy with aprepitant, palonosetron and dexamethasone as highly emetic anthracycline-containing adjuvant chemotherapy for primary breast cancer patients were prospectively investigated. Forty-five patients with breast cancer who experienced >Grade 1 nausea or any vomiting after the first cycle of chemotherapy using both epirubicin and cyclophosphamide were included. Low-dose olanzapine (2.5 mg/day) was administered orally from the first day of chemotherapy for 4 days, and the number of episodes of vomiting, scale of nausea, dietary intake and somnolence were compared with the symptoms after the first cycle. As the primary endpoint, the nausea grade was significantly improved by adding olanzapine (P effectiveness and tolerability of adding low-dose olanzapine for patients with insufficient nausea relief with triplet antiemetic therapy consisting of palonosetron, steroid and aprepitant. Published by Oxford University Press 2016. This work is written by (a) US Government employee(s) and is in the public domain in the US.

  19. Determination of olanzapine and N-desmethyl-olanzapine in plasma using a reversed-phase HPLC coupled with coulochemical detection: correlation of olanzapine or N-desmethyl-olanzapine concentration with metabolic parameters.

    Mong-Liang Lu

    Full Text Available Olanzapine (OLZ is one of the most prescribed atypical antipsychotic drugs but its use is associated with unfavorable metabolic abnormalities. N-desmethyl-olanzapine (DMO, one of the OLZ metabolites by CYP1A2, has been reported to have a normalizing action on metabolic abnormalities, but this remains unclear. Our aim was to explore the correlation between the concentrations of OLZ or DMO with various metabolic parameters in schizophrenic patients.The chromatographic analysis was carried out with a solvent delivery system coupled to a Coulochem III coulometric detector to determine OLZ and DMO simultaneously in OLZ-treated patients. The correlation between the concentration of OLZ or DMO and the metabolic parameters was analyzed by the Spearman rank order correlation method (r s.The established analytical method met proper standards for accuracy and reliability and the lower limitation of quantification for each injection of DMO or OLZ was 0.02 ng. The method was successfully used for the analysis of samples from nonsmoking patients (n = 48 treated with OLZ in the dosage range of 5-20 mg per day. There was no correlation between OLZ concentrations and tested metabolic parameters. DMO concentrations were negatively correlated with glucose (r s = -0.45 and DMO concentrations normalized by doses were also negatively correlated with insulin levels (r s = -0.39; however, there was a marginally positive correlation between DMO and homocysteine levels (r s = +0.38.The observed negative correlations between levels of DMO and glucose or insulin suggest a metabolic normalization role for DMO regardless of its positive correlation with a known cardiovascular risk factor, homocysteine. Additional studies of the mechanisms underlying DMO's metabolic effects are warranted.

  20. Olanzapine-induced weight gain: chronic infusion using osmotic minipumps does not result in stable plasma levels due to degradation of olanzapine in solution

    van der Zwaal, Esther M.; Luijendijk, Mieneke C. M.; Adan, Roger A. H.; la Fleur, Susanne E.


    The mechanisms underlying olanzapine-induced weight gain have not yet been fully elucidated. To examine the effects of long-term treatment with olanzapine on different aspects of energy balance, we administered olanzapine to male rats. Osmotic minipumps were chosen as preferred mode of

  1. Image processing of angiograms: A pilot study

    Larsen, L. E.; Evans, R. A.; Roehm, J. O., Jr.


    The technology transfer application this report describes is the result of a pilot study of image-processing methods applied to the image enhancement, coding, and analysis of arteriograms. Angiography is a subspecialty of radiology that employs the introduction of media with high X-ray absorption into arteries in order to study vessel pathology as well as to infer disease of the organs supplied by the vessel in question.

  2. Seaside, Oregon, Tsunami Vulnerability Assessment Pilot Study

    Dunbar, P. K.; Dominey-Howes, D.; Varner, J.


    The results of a pilot study to assess the risk from tsunamis for the Seaside-Gearhart, Oregon region will be presented. To determine the risk from tsunamis, it is first necessary to establish the hazard or probability that a tsunami of a particular magnitude will occur within a certain period of time. Tsunami inundation maps that provide 100-year and 500-year probabilistic tsunami wave height contours for the Seaside-Gearhart, Oregon, region were developed as part of an interagency Tsunami Pilot Study(1). These maps provided the probability of the tsunami hazard. The next step in determining risk is to determine the vulnerability or degree of loss resulting from the occurrence of tsunamis due to exposure and fragility. The tsunami vulnerability assessment methodology used in this study was developed by M. Papathoma and others(2). This model incorporates multiple factors (e.g. parameters related to the natural and built environments and socio-demographics) that contribute to tsunami vulnerability. Data provided with FEMA's HAZUS loss estimation software and Clatsop County, Oregon, tax assessment data were used as input to the model. The results, presented within a geographic information system, reveal the percentage of buildings in need of reinforcement and the population density in different inundation depth zones. These results can be used for tsunami mitigation, local planning, and for determining post-tsunami disaster response by emergency services. (1)Tsunami Pilot Study Working Group, Seaside, Oregon Tsunami Pilot Study--Modernization of FEMA Flood Hazard Maps, Joint NOAA/USGS/FEMA Special Report, U.S. National Oceanic and Atmospheric Administration, U.S. Geological Survey, U.S. Federal Emergency Management Agency, 2006, Final Draft. (2)Papathoma, M., D. Dominey-Howes, D.,Y. Zong, D. Smith, Assessing Tsunami Vulnerability, an example from Herakleio, Crete, Natural Hazards and Earth System Sciences, Vol. 3, 2003, p. 377-389.

  3. The atrial fibrillation ablation pilot study

    Arbelo, Elena; Brugada, Josep; Hindricks, Gerhard


    AIMS: The Atrial Fibrillation Ablation Pilot Study is a prospective registry designed to describe the clinical epidemiology of patients undergoing an atrial fibrillation (AFib) ablation, and the diagnostic/therapeutic processes applied across Europe. The aims of the 1-year follow-up were to analyse...... was achieved in 40.7% of patients (43.7% in paroxysmal AF; 30.2% in persistent AF; 36.7% in long-lasting persistent AF). A second ablation was required in 18% of the cases and 43.4% were under antiarrhythmic treatment. Thirty-three patients (2.5%) suffered an adverse event, 272 (21%) experienced a left atrial...... tachycardia, and 4 patients died (1 haemorrhagic stroke, 1 ventricular fibrillation in a patient with ischaemic heart disease, 1 cancer, and 1 of unknown cause). CONCLUSION: The AFib Ablation Pilot Study provided crucial information on the epidemiology, management, and outcomes of catheter ablation of AFib...

  4. Long-acting injectable antipsychotics: focus on olanzapine pamoate

    JP Lindenmayer


    Full Text Available JP LindenmayerDepartment of Psychiatry, New York University School of Medicine, New York NY, USAAbstract: Medication non-adherence in patients with schizophrenia continues to be a significant problem and threatens successful treatment outcomes. Medication non-adherence is often associated with negative consequences, including symptom exacerbation, more frequent emergency room visits, re-hospitalizations and relapse. Long-acting injectable (LAI forms of antipsychotics allow for rapid identification of non-adherence, obviate the need for the patient to take the medication on a daily basis and increase adherence to some significant degree. Eli Lilly has developed a long-acting depot formulation of olanzapine, olanzapine pamoate, which has recently been approved by the FDA for the US market, and which will be reviewed here. Olanzapine LAI appears to be an effective antipsychotic at dosages of 210 mg every 2 weeks, 300 mg every 2 weeks and 405 mg every 4 weeks in patients with acute schizophrenia, and at 150 mg every 2 weeks, 300 mg every 2 weeks and at 405 mg every 4 weeks for the maintenance treatment of stable patients. Oral supplementation appears not to be needed, particularly not at the onset of treatment with the LAI as is necessary with risperidone LAI. Its efficacy is in general comparable to the efficacy seen with oral olanzapine at a corresponding dose. The side effect profile is also comparable to the side effects observed with oral olanzapine, including lower rates of extrapyramidal symptoms, prolactin elevation and cardiovascular side effects, but significant metabolic effects. The latter include significant weight gain, lipid abnormalities and glucose dysregulation. While the injection site adverse events are overall mild, the most significant serious adverse event is the post-injection delirium sedation syndrome (PDSS. While rare, this syndrome results from inadvertent intravascular injection of olanzapine LAI and can cause a range of

  5. [The lipid metabolism abnormality in patients administered with olanzapine].

    Amano, Taku; Hosaka, Shigetoshi; Takami, Hiroshi; Sugiyama, Chie; Oda, Kazue; Morikawa, Ryuichi


    The atypical antipsychotic medication olanzapine is a useful agent in acute and maintenance treatment of schizophrenia and related disorders. It has beneficial effects on both positive and negative symptoms, an early onset of antipsychotic action and a favourable side effect profile. On the other hand, olanzapine has many reports of causing weight gain, glucose metabolism disturbances and lipidosis. We carried out blood tests (leptin, adiponectin, remnant-like lipoprotein cholesterol (RLP-C), total cholesterol, HbA1C, 75-OGTT and etc.) on patients with schizophrenia who had taken olanzapine. As a result, leptin, neutral lipid and RLP-C were significantly correlated by BMI. (The average blood test data and BMI revealed a normal range). Most analysis results of the lipoprotein fraction by a polyacrylamide-gel-electrophoresis method were normal patterns. Furthermore, the serum insulin concentrations from 75 g glucose tolerance (75 g-OGTT) 30 minutes later, in one third of patients receiving olanzapine, registered more than 100 microU/ml. The mechanism of the insulin secretion rise by olannzapine is unknown. Olanzapine may impair glucose tolerance due in part to increased insulin resistance. These findings do not necessarily imply that olanzapine is directly associated with a risk of impairment of weight gain, glucose metabolism disturbances and lipidosis. These results suggest that it is useful to promote diet cure and exercise therapy with patients with high BMI levels.

  6. Pancreatitis following Olanzapine Therapy: A Report of Three Cases

    Thomas A. Kerr


    Full Text Available Context: Atypical antipsychotic agents (clozapine, olanzapine have been linked to metabolic effects and acute pancreatitis. Case Report: We reviewed the inpatient and outpatient records of three patients who developed acute pancreatitis while being treated with olanzapine. The mean age of the patients was 37.7 years (range 18–54 years, 2 female, 1 male. No alternative cause of acute pancreatitis was found in two of the three patients. In the remaining patient, olanzapine may have contributed to acute pancreatitis in the setting of hypertriglyceridemia. Olanzapine was discontinued in all instances. Over a mean follow-up of 14 months, one patient has had a relapsing course, but the remaining two patients have been symptom free without recurrence of acute pancreatitis. Conclusions: Our case series adds further support to the potential link between olanzapine use and acute pancreatitis. Close monitoring of metabolic parameters is suggested in patients treated with olanzapine. Alternative antipsychotic agents should be considered in patients at high risk for pancreatitis.

  7. Centrifuge Study of Pilot Tolerance to Acceleration and the Effects of Acceleration on Pilot Performance

    Creer, Brent Y.; Smedal, Harald A.; Wingrove, Rodney C.


    A research program the general objective of which was to measure the effects of various sustained accelerations on the control performance of pilots, was carried out on the Aviation Medical Acceleration Laboratory centrifuge, U.S. Naval Air Development Center, Johnsville, PA. The experimental setup consisted of a flight simulator with the centrifuge in the control loop. The pilot performed his control tasks while being subjected to acceleration fields such as might be encountered by a forward-facing pilot flying an atmosphere entry vehicle. The study was divided into three phases. In one phase of the program, the pilots were subjected to a variety of sustained linear acceleration forces while controlling vehicles with several different sets of longitudinal dynamics. Here, a randomly moving target was displayed to the pilot on a cathode-ray tube. For each combination of acceleration field and vehicle dynamics, pilot tracking accuracy was measured and pilot opinion of the stability and control characteristics was recorded. Thus, information was obtained on the combined effects of complexity of control task and magnitude and direction of acceleration forces on pilot performance. These tests showed that the pilot's tracking performance deteriorated markedly at accelerations greater than about 4g when controlling a lightly damped vehicle. The tentative conclusion was also reached that regardless of the airframe dynamics involved, the pilot feels that in order to have the same level of control over the vehicle, an increase in the vehicle dynamic stability was required with increases in the magnitudes of the acceleration impressed upon the pilot. In another phase, boundaries of human tolerance of acceleration were established for acceleration fields such as might be encountered by a pilot flying an orbital vehicle. A special pilot restraint system was developed to increase human tolerance to longitudinal decelerations. The results of the tests showed that human tolerance

  8. USGS Tampa Bay Pilot Study

    Yates, K.K.; Cronin, T. M.; Crane, M.; Hansen, M.; Nayeghandi, A.; Swarzenski, P.; Edgar, T.; Brooks, G.R.; Suthard, B.; Hine, A.; Locker, S.; Willard, D.A.; Hastings, D.; Flower, B.; Hollander, D.; Larson, R.A.; Smith, K.


    Many of the nation's estuaries have been environmentally stressed since the turn of the 20th century and will continue to be impacted in the future. Tampa Bay, one the Gulf of Mexico's largest estuaries, exemplifies the threats that our estuaries face (EPA Report 2001, Tampa Bay Estuary Program-Comprehensive Conservation and Management Plan (TBEP-CCMP)). More than 2 million people live in the Tampa Bay watershed, and the population constitutes to grow. Demand for freshwater resources, conversion of undeveloped areas to resident and industrial uses, increases in storm-water runoff, and increased air pollution from urban and industrial sources are some of the known human activities that impact Tampa Bay. Beginning on 2001, additional anthropogenic modifications began in Tampa Bat including construction of an underwater gas pipeline and a desalinization plant, expansion of existing ports, and increased freshwater withdrawal from three major tributaries to the bay. In January of 2001, the Tampa Bay Estuary Program (TBEP) and its partners identifies a critical need for participation from the U.S. Geological Survey (USGS) in providing multidisciplinary expertise and a regional-scale, integrated science approach to address complex scientific research issue and critical scientific information gaps that are necessary for continued restoration and preservation of Tampa Bay. Tampa Bay stakeholders identified several critical science gaps for which USGS expertise was needed (Yates et al. 2001). These critical science gaps fall under four topical categories (or system components): 1) water and sediment quality, 2) hydrodynamics, 3) geology and geomorphology, and 4) ecosystem structure and function. Scientists and resource managers participating in Tampa Bay studies recognize that it is no longer sufficient to simply examine each of these estuarine system components individually, Rather, the interrelation among system components must be understood to develop conceptual and

  9. Metformin for olanzapine-induced weight gain: a systematic review and meta-analysis.

    Praharaj, Samir Kumar; Jana, Amlan Kusum; Goyal, Nishant; Sinha, Vinod Kumar


    Olanzapine is an atypical antipsychotic that is useful in schizophrenia and bipolar affective disorder, but its use is associated with troublesome weight gain and metabolic syndrome. A variety of pharmacological agents has been studied in the efforts to reverse weight gain induced by olanzapine, but current evidence is insufficient to support any particular pharmacological approach. We conducted a systematic review and meta-analysis of randomized controlled trials of metformin for the treatment of olanzapine-induced weight gain. Systematic review of the literature revealed 12 studies that had assessed metformin for antipsychotic-induced weight gain. Of these, four studies (n= 105) met the review inclusion criteria and were included in the final analysis. Meta-analysis was performed to see the effect size of the treatment on body weight, waist circumference and body-mass index (BMI). Weighted mean difference (WMD) for body weight was 5.02 (95% CI 3.93, 6.10) kg lower with metformin as compared with placebo at 12 weeks. For waist circumference, the test for heterogeneity was significant (P= 0.00002, I(2) = 85.1%). Therefore, a random effects model was used to calculate WMD, which was 1.42 (95% CI 0.29, 3.13) cm lower with metformin as compared with placebo at 12 weeks. For BMI, WMD was 1.82 (95% CI 1.44, 2.19) kg m(-2) lower with metformin as compared with placebo at 12 weeks. Existing data suggest that short term modest weight loss is possible with metformin in patients with olanzapine-induced weight gain. © 2011 The Authors. British Journal of Clinical Pharmacology © 2011 The British Pharmacological Society.

  10. Pre-Study Walkthrough with a Commercial Pilot for a Preliminary Single Pilot Operations Experiment

    O'Connor-Dreher, Ryan; Roberts, Z.; Ziccardi, J.; Vu, K-P. L.; Strybel, T.; Koteskey, Robert William; Lachter, Joel B.; Vi Dao, Quang; Johnson, Walter W.; Battiste, V.


    The number of crew members in commercial flights has decreased to two members, down from the five-member crew required 50 years ago. One question of interest is whether the crew should be reduced to one pilot. In order to determine the critical factors involved in safely transitioning to a single pilot, research must examine whether any performance deficits arise with the loss of a crew member. With a concrete understanding of the cognitive and behavioral role of a co-pilot, aeronautical technologies and procedures can be developed that make up for the removal of the second aircrew member. The current project describes a pre-study walkthrough process that can be used to help in the development of scenarios for testing future concepts and technologies for single pilot operations. Qualitative information regarding the tasks performed by the pilots can be extracted with this technique and adapted for future investigations of single pilot operations.

  11. Treatment with olanzapine is associated with modulation of the default mode network in patients with Schizophrenia.

    Sambataro, Fabio; Blasi, Giuseppe; Fazio, Leonardo; Caforio, Grazia; Taurisano, Paolo; Romano, Raffaella; Di Giorgio, Annabella; Gelao, Barbara; Lo Bianco, Luciana; Papazacharias, Apostolos; Popolizio, Teresa; Nardini, Marcello; Bertolino, Alessandro


    Earlier studies have shown widespread alterations of functional connectivity of various brain networks in schizophrenia, including the default mode network (DMN). The DMN has also an important role in the performance of cognitive tasks. Furthermore, treatment with second-generation antipsychotic drugs may ameliorate to some degree working memory (WM) deficits and related brain activity. The aim of this study was to evaluate the effects of treatment with olanzapine monotherapy on functional connectivity among brain regions of the DMN during WM. Seventeen patients underwent an 8-week prospective study and completed two functional magnetic resonance imaging (fMRI) scans at 4 and 8 weeks of treatment during the performance of the N-back WM task. To control for potential repetition effects, 19 healthy controls also underwent two fMRI scans at a similar time interval. We used spatial group-independent component analysis (ICA) to analyze fMRI data. Relative to controls, patients with schizophrenia had reduced connectivity strength within the DMN in posterior cingulate, whereas it was greater in precuneus and inferior parietal lobule. Treatment with olanzapine was associated with increases in DMN connectivity with ventromedial prefrontal cortex, but not in posterior regions of DMN. These results suggest that treatment with olanzapine is associated with the modulation of DMN connectivity in schizophrenia. In addition, our findings suggest critical functional differences in the regions of DMN.

  12. Contextual and behavioral control of antipsychotic sensitization induced by haloperidol and olanzapine

    Zhang, Chen; Li, Ming


    Repeated administration of haloperidol and olanzapine causes a progressively enhanced disruption of conditioned avoidance response (CAR) and a progressively enhanced inhibition of phencyclidine (PCP)-induced hyperlocomotion in rats (termed antipsychotic sensitization). Both actions are thought to reflect intrinsic antipsychotic activity. The present study examined to the extent to which antipsychotic-induced sensitization in one model (e.g. CAR) can be transferred or maintained in another (e.g. PCP hyperlocomotion) as a means of investigating the contextual and behavioral controls of antipsychotic sensitization. Well-trained male Sprague-Dawley rats were first repeatedly tested in the CAR or PCP (3.2 mg/kg, sc) hyperlocomotion model under haloperidol or olanzapine for five consecutive days. Then they were switched to the other model and tested for the expression of sensitization. Finally, all rats were switched back to the original model and retested for the expression of sensitization. Repeated haloperidol or olanzapine treatment progressively disrupted avoidance responding and decreased PCP-induced hyperlocomotion, indicating a robust sensitization. When tested in a different model, rats previously treated with haloperidol or olanzapine did not show a stronger inhibition of CAR or PCP-induced hyperlocomotion than those treated with these drugs for the first time; however, they did show such an effect when tested in the original model in which they received repeated antipsychotic treatment. These findings suggest that the expression of antipsychotic sensitization is strongly influenced by the testing environment and/or selected behavioral response under certain experimental conditions. Distinct contextual cues and behavioral responses may enter an association with unconditional drug effects via a Pavlovian conditioning process. They may also serve as occasion-setters to modulate the expression of sensitized responses. Because antipsychotic sensitization mimics

  13. Chronic treatment with olanzapine increases adiposity by changing fuel substrate and causes desensitization of the acute metabolic side effects

    Girault, Elodie M.; Guigas, Bruno; Alkemade, Anneke; Foppen, Ewout; Ackermans, Mariëtte T.; la Fleur, Susanne E.; Fliers, Eric; Kalsbeek, Andries


    Atypical antipsychotic drugs such as olanzapine induce weight gain and metabolic changes associated with the development of type 2 diabetes. The mechanisms underlying these metabolic side-effects are unknown at the moment. In this study, we investigated the metabolic changes induced by a chronic

  14. Chronic treatment with olanzapine increases adiposity by changing fuel substrate and causes desensitization of the acute metabolic side effects

    Girault, Elodie M; Guigas, Bruno; Alkemade, Anneke; Foppen, Ewout; Ackermans, Mariëtte T; la Fleur, Susanne E; Fliers, Eric; Kalsbeek, A.

    Atypical antipsychotic drugs such as olanzapine induce weight gain and metabolic changes associated with the development of type 2 diabetes. The mechanisms underlying these metabolic side-effects are unknown at the moment. In this study, we investigated the metabolic changes induced by a chronic

  15. Sertindole, in contrast to clozapine and olanzapine, does not disrupt water maze performance after acute or chronic treatment

    Didriksen, Michael; Kreilgaard, Mads; Arnt, Jørn


    Cognitive deficits in schizophrenia are associated with poor functional outcome, and may be further aggravated by treatment with antipsychotics. In the present study the acute and chronic (3 weeks of treatment) effects of clozapine, olanzapine, and sertindole on performance in the Morris water ma...

  16. Quality of life and adverse effects of olanzapine versus risperidone therapy in patients with schizophrenia.

    Chaves, Katarina Melo; Serrano-Blanco, Antoni; Ribeiro, Susana Barbosa; Soares, Luiz Alberto Lira; Guerra, Gerlane Coelho Bernardo; do Socorro Costa Feitosa Alves, Maria; de Araújo Júnior, Raimundo Fernandes; de Paula Soares Rachetti, Vanessa; Filgueira Júnior, Antônio; de Araújo, Aurigena Antunes


    This cross-sectional study aimed to compare the effects of treatment with an atypical antipsychotic drug (olanzapine or risperidone) on quality of life (QoL) and to document adverse effects in 115 patients diagnosed with schizophrenia who attended the ambulatory service of Hospital Dr. João Machado, Natal, Rio Grande do Norte, Brazil. Socioeconomic, sociodemographic, and clinical variables were compared. The QoL Scale validated for Brazil (QLS-BR) was used to evaluate QoL, and adverse effects were assessed using the Udvalg for Kliniske Undersøgelser Side Effect Rating Scale. Data were analyzed using the χ(2) test and Student's t test, with a significance level of 5 %. Patients in both drug groups showed severe impairment in the occupational domain of the QLS-BR. Global QLS-BR scores indicated impairment among risperidone users and severe impairment among olanzapine users. The most significant side effects were associated with risperidone, including asthenia/lassitude/fatigue, somnolence/sedation, paresthesia, change in visual accommodation, increased salivation, diarrhea, orthostatic posture, palpitations/tachycardia, erythema, photosensitivity, weight loss, galactorrhea, decreased sexual desire, erectile/orgasmic dysfunction, vaginal dryness, headache, and physical dependence. QoL was impaired in patients using olanzapine and in those using risperidone. Risperidone use was associated with psychic, neurological, and autonomous adverse effects and other side effects.

  17. Changes in prefrontal and amygdala activity during olanzapine treatment in schizophrenia.

    Blasi, Giuseppe; Popolizio, Teresa; Taurisano, Paolo; Caforio, Grazia; Romano, Raffaella; Di Giorgio, Annabella; Sambataro, Fabio; Rubino, Valeria; Latorre, Valeria; Lo Bianco, Luciana; Fazio, Leonardo; Nardini, Marcello; Weinberger, Daniel R; Bertolino, Alessandro


    Earlier imaging studies in schizophrenia have reported abnormal amygdala and prefrontal cortex activity during emotion processing. We investigated with functional magnetic resonance imaging (fMRI) during emotion processing changes in activity of the amygdala and of prefrontal cortex in patients with schizophrenia during 8 weeks of olanzapine treatment. Twelve previously drug-free/naive patients with schizophrenia were treated with olanzapine for 8 weeks and underwent two fMRI scans after 4 and 8 weeks of treatment during implicit and explicit emotional processing. Twelve healthy subjects were also scanned twice to control for potential repetition effects. Results showed a diagnosis by time interaction in left amygdala and a diagnosis by time by task interaction in right ventrolateral prefrontal cortex. In particular, activity in left amygdala was greater in patients than in controls at the first scan during both explicit and implicit processing, while it was lower in patients at the second relative to the first scan. Furthermore, during implicit processing, right ventrolateral prefrontal cortex activity was lower in patients than controls at the first scan, while it was greater in patients at the second relative to the first scan. These results suggest that longitudinal treatment with olanzapine may be associated with specific changes in activity of the amygdala and prefrontal cortex during emotional processing in schizophrenia.

  18. Comparison of the effect of Olanzapine and Sertraline on patients suffering from personality disorder, receiving methadone maintenance therapy

    mozhgan Jariani


    Full Text Available Background: Borderline Personality disorder is a disabling disease affecting 2% of general population. Various drugs have been suggested for treatment of borderline Personality disorder. If a drug could alleviate a wide range of symptoms, it would be more suitable. In these disorders drug addiction is very common. This fact makes the symptoms complicated and the treatment more difficult. This study is designed to evaluate the effect of Olanzapine and Sertraline in patients suffering from personality disorders who are on methadone maintenance therapy. Materials and Methods: This clinical trial study was carried out on 120 male and female cases chosen for methadone maintenance therapy through interview by a psychiatrist based on DSM-IV-TR diagnostic criteria for BPD. Afterwards they were randomly divided into two groups. These groups separately received Olanzapine (5-10 mg daily and Sertraline (50-100 mg daily therapy. The SCL-90 questionnaire was filled out by the participants before treatment and at the 4th, 8th and 12th weeks of the treatment. Results: According to this clinical trial, Olanzapine and Sertraline were effective in ameliorating symptoms of depression, anxiety and aggression, reducing sensitivity in interpersonal relationship and alleviating obsessive symptoms, pessimistic behaviors and somatization disorders in patients with personality disorders on methadone maintenance therapy. Conclusion: As results of this study stated that Olanzapine and Sertraline are definitely effective in alleviating symptoms of patients with personality disorder, prescribing theses drugs are highly recommended for these patients. .

  19. MALDI-MS analysis and theoretical evaluation of olanzapine as a UV laser desorption ionization (LDI) matrix.

    Musharraf, Syed Ghulam; Ameer, Mariam; Ali, Arslan


    Matrix-assisted laser desorption/ionization mass spectrometry (MALDI-MS) being soft ionization technique, has become a method of choice for high-throughput analysis of proteins and peptides. In this study, we have explored the potential of atypical anti-psychotic drug olanzapine (OLZ) as a matrix for MALDI-MS analysis of peptides aided with the theoretical studies. Seven small peptides were employed as target analytes to check performance of olanzapine and compared with conventional MALDI matrix α-cyano-4-hydroxycinnamic acid (HCCA). All peptides were successfully detected when olanzapine was used as a matrix. Moreover, peptides angiotensin Ι and angiotensin ΙΙ were detected with better S/N ratio and resolution with this method as compared to their analysis by HCCA. Computational studies were performed to determine the thermochemical properties of olanzapine in order to further evaluate its similarity to MALDI matrices which were found in good agreement with the data of existing MALDI matrices. Copyright © 2016. Published by Elsevier B.V.

  20. Olanzapine and sibutramine have opposing effects on the motivation for palatable food

    van der Zwaal, Esther M.; Janhunen, Sanna K.; Luijendijk, Mieneke C. M.; Baclesanu, Roxana; Vanderschuren, Louk J. M. J.; Adan, Roger A. H.; la Fleur, Susanne E.


    Both olanzapine and sibutramine target serotonergic and noradrenergic neurotransmission and influence body weight, but in opposite ways. The second-generation antipsychotic olanzapine, an antagonist at serotonergic and noradrenergic receptors, frequently induces weight gain as a side-effect, whereas

  1. Cytogenetics of jaw cysts - a pilot study.

    Manor, Esther; Brennan, Peter A; Bodner, Lipa


    The pathogenesis of cysts that arise in the jaws is still not certain, and the underlying mechanisms of epithelial proliferation are not fully understood. Cysts of the jaw may involve a reactive, inflammatory, or neoplastic process. Cytogenetics, the study of the number and structure of chromosomes, has provided valuable information about the diagnosis, prognosis, and targeted treatment in many cancers, including oral squamous cell carcinoma. Cytogenetics can also provide information about the possible aetiology or neoplastic potential of a lesion, though to our knowledge no studies of this technique have been used for cysts in the jaws. In this pilot study we used cytogenetics in a series of 10 cysts (3 radicular, 4 dentigerous, 2 of the nasopalatine duct, and 1 dermoid). In all cases we found normal karyotypes. Further work and larger numbers are needed for a definitive study, but we can hypothesise from this pilot study that these cysts do not have cytogenetic aberrations and so have no neoplastic potential. Copyright © 2011 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  2. Association of metabolic syndrome with atypical antipsychotic drug (olanzapine) short term versus long term use

    Ikram, H.; Ahmed, T.M.; Hayat, A.; Ullah, Q.I.; Nawaz, A.


    Objective: To determine the association of metabolic syndrome with atypical antipsychotic drug (olanzapine) short term versus long term use. Study Design: Case control study. Place and Duration of Study: Chemical pathology department Army Medical College Rawalpindi, from Nov 2014 to Oct 2015. Material and Methods: The study was carried out on 240 subjects, 120 cases and 120 controls. For the purpose of the study cases were divided into four groups A, B, C and D according to the duration of drug use. Group A patients included those who the last the drug olanzapine for the last three months. Group B patients included those who were using the drug olanzapine for the last six months. Group C and D included those who were using the drug for last 1 year and more than one year (2-5 years) respectively. By employing non probability convenience sampling technique the data was collected from patients having the diagnosis of psychosis as per DSM IV modified criteria through a proforma and fasting blood samples were drawn. These samples were tested for fasting serum lipid profile and fasting plasma glucose. The data obtained were analyzed using SPSS version 21. For quantitative data Mean and SD were calculated. For qualitative data frequency and percentages were calculated. Qualitative data was compared using chi square test whereas quantitative data was compared using independent sample t-test. Results: There was statistically no significant difference in fasting plasma glucose between group A and B and their controls whereas in group C and D these levels were significantly high as compared to controls. Triglyceride levels were significantly higher and HDL cholesterol levels were significantly lower in all four groups as compared to controls. Comparison of qualitative data which included waist circumference and blood pressure showed statistically no significant rise for group A whereas waist circumference showed insignificant rise and blood pressure showed statistically

  3. Doing A Pilot Study: Why Is It Essential?

    Hassan, Zailinawati Abu; Schattner, Peter; Mazza, Danielle


    A pilot study is one of the essential stages in a research project. This paper aims to describe the importance of and steps involved in executing a pilot study by using an example of a descriptive study in primary care. The process of testing the feasibility of the project proposal, recruitment of subjects, research tool and data analysis was reported. We conclude that a pilot study is necessary and useful in providing the groundwork in a research project.


    Zailinawati Abu Hassan


    Full Text Available A pilot study is one of the essential stages in a research project. This paper aims to describe the importance of and steps involved in executing a pilot study by using an example of a descriptive study in primary care. The process of testing the feasibility of the project proposal, recruitment of subjects, research tool and data analysis was reported. We conclude that a pilot study is necessary and useful in providing the groundwork in a research project.

  5. Drug–drug conditioning between citalopram and haloperidol or olanzapine in a conditioned avoidance response model: implications for polypharmacy in schizophrenia

    Sparkman, Nathan L.; Li, Ming


    Patients with schizophrenia often have anxiety and depression, and thus are treated with multiple psychotherapeutic medications. This practice of polypharmacy increases the possibility for drug–drug interactions. However, the pharmacological and behavioral mechanisms underlying drug–drug interactions in schizophrenia remain poorly understood. In the present study, we adopted a preclinical approach and examined a less known behavioral mechanism, drug–drug conditioning (DDC) between haloperidol (a typical antipsychotic) or olanzapine (atypical antipsychotic) and citalopram (a selective serotonin reuptake inhibitor). A rat two-way conditioned avoidance response paradigm was used to measure antipsychotic activity and determine how DDC may alter the antipsychotic efficacy in this model. Following acquisition of the avoidance response, rats were then randomly assigned to receive vehicle, citalopram (10.0 mg/kg, intraperitoneally), haloperidol (0.05 mg/kg, subcutaneously), olanzapine (1.0 mg/kg, subcutaneously), combined haloperidol with citalopram, or combined olanzapine with citalopram treatment for seven avoidance test sessions. In comparison with antipsychotic treatment alone, combined treatment with citalopram potentiated the antiavoidance effect of olanzapine or haloperidol (to a lesser extent) during the seven drug-test sessions. In addition, repeated pairing of citalopram with haloperidol or olanzapine caused citalopram to show a newly acquired avoidance-disruptive effect. This effect was context specific because citalopram paired with haloperidol or olanzapine outside the avoidance testing context (i.e. home cages) did not show such an effect. These findings indicate that concurrent antidepressant and antipsychotic treatments may engender a DDC process that follows the general Pavlovian associative conditioning principles. They also indicate that adjunctive citalopram treatment may enhance the antipsychotic efficacy of haloperidol and olanzapine in the

  6. Pilot Study for Maintenance Rule at KSNP

    Choi, Kwang Hee; Jeong, Hyeon Jong; Jee, Moon Hak; Hong, Sung Yull


    Maintenance Rule (MR), which was developed to monitor the effectiveness of maintenance in a nuclear power plant (NPP), has been received as highly successful program by and large since its implementation in 1996 in the United States. Korea has initiated two pilot programs to implement the Maintenance Rule program in 2003. Selected plants for the pilot implementation are Kori 3 and 4 units and Ulchin 3 and 4 units, where Kori 3 and 4 units are Westinghouse units and Ulchin 3 and 4 units are Korean Standardized Nuclear Power (KSNP) Plant units. This paper describes the results of each key tasks completed to date and insights gained from pilot study on the KSNP units. Currently, Scoping of the functions of maintenance rule and determination of safety significance level have been completed during first year. As first task, total 607 functions were identified and defined by detailed function analysis on 135 systems that cover all plant systems. About 55% of total functions are selected as within the scope of maintenance rule. Among these inscoped functions, 56% of scoped functions are safety related and 44% are non-safety related functions. Evaluation of safety significance for each function was determined by expert panel consist of eight experts in field of plant maintenance, operation, PSA, work schedule and system engineers. As a result, about 46% of functions were determined to be high safety significant functions and rest of the functions were classified as low safety significant. The remaining tasks that are included determination of performance criteria and preparation of implementing guideline will be performed in following years

  7. Delirium Associated with Olanzapine Therapy in an Elderly Male with Bipolar Affective Disorder

    Sharma, Ravi C.; Aggarwal, Ashish


    Atypical antipsychotic medications are commonly used to treat symptoms of delirium. Olanzapine has been successfully used in the treatment of delirium. However, there have been few case reports of delirium associated with olanzapine. We hereby report a case of delirium associated with olanzapine therapy. Possible risk factors and underlying pathogenesis is discussed.

  8. Olanzapine causes hypothermia, inactivity, a deranged feeding pattern and weight gain in female Wistar rats

    Evers, S. S.; Calcagnoli, F.; van Dijk, G.; Scheurink, A. J. W.


    Olanzapine is an a-typical antipsychotic drug antagonizing predominantly 5-HT and dopamine but also histamine muscarin and a adrenergic receptors In humans Olanzapine induces weight gain and increases the risk of type 2 diabetes The underlying mechanisms of Olanzapine-induced weight gain are unclear

  9. Epidemiologic studies of pilots and aircrew.

    Boice, J D; Blettner, M; Auvinen, A


    During flight, pilots and cabin crew are exposed to increased levels of cosmic radiation which consists primarily of neutrons and gamma rays. Neutron dosimetry is not straightforward, but typical annual effective doses are estimated to range between two and five mSv. Higher dose rates are experienced at the highest altitudes and in the polar regions. Mean doses have been increasing over time as longer flights at higher altitudes have become more frequent. Because there are so few populations exposed to neutrons, studies of airline personnel are of particular interest. However, because the cumulative radiation exposure is so low, statistical power is a major concern. Further, finding an appropriate comparison group is problematic due to selection into these occupations and a number of biases are possible. For example, increased rates of breast cancer among flight attendants have been attributed to reproductive factors such as nulliparity and increased rates of melanoma among pilots have been attributed to excessive sun exposure during leisure time activities. Epidemiologic studies conducted over the last 20 y provide little consistent evidence linking cancer with radiation exposures from air travel.

  10. Natural oils as skin permeation enhancers for transdermal delivery of olanzapine: in vitro and in vivo evaluation.

    Aggarwal, Geeta; Dhawan, Sanju; HariKumar, S L


    The feasibility of development of transdermal delivery system of olanzapine utilizing natural oils as permeation enhancers was investigated. Penetration enhancing potential of corn (maize) oil, groundnut oil and jojoba oil on in vitro permeation of olanzapine across rat skin was studied. The magnitude of flux enhancement factor with corn oil, groundnut oil and jojoba oil was 7.06, 5.31 and 1.9 respectively at 5mg/ml concentration in solvent system. On the basis of in vitro permeation studies, eudragit based matrix type transdermal patches of olanzapine were fabricated using optimized concentrations of natural oils as permeation enhancers. All transdermal patches were found to be uniform with respect to physical characteristics. The interaction studies carried out by comparing the results of ultraviolet, HPLC and FTIR analyses for the pure drug, polymers and mixture of drug and polymers indicated no chemical interaction between the drug and excipients. Corn oil containing unsaturated fatty acids was found to be promising natural permeation enhancer for transdermal delivery of olanzapine with greatest cumulative amount of drug permeated (1010.68 μg/cm²/h) up to 24 h and caused no skin irritation. The fabricated transdermal patches were found to be stable. The pharmacokinetic characteristics of the final optimized matrix patch (T2) were determined after transdermal application to rabbits. The calculated relative bioavailability of TDDS was 113.6 % as compared to oral administration of olanzapine. The therapeutic effectiveness of optimized transdermal system was confirmed by tranquillizing activity in rotarod and grip mice model.

  11. Treatment response to olanzapine and haloperidol and its association with dopamine D receptor occupancy in first-episode psychosis.

    Zipursky, Robert B; Christensen, Bruce K; Daskalakis, Zafiris; Epstein, Irvin; Roy, Paul; Furimsky, Ivana; Sanger, Todd; Kapur, Shitij


    Response to typical antipsychotic medication has been associated with achieving a level of striatal dopamine D2 receptor occupancy in the range of 65% to 70%. We undertook this study to determine whether response to the atypical antipsychotic olanzapine occurs at lower levels of D2 receptor occupancy. Eighteen patients who presented with a first episode of psychosis were randomized to receive olanzapine 5 mg daily or haloperidol 2 mg daily in a double-blind design. We acquired positron emission tomography (PET) scans using the D2 ligand [11C]raclopride within the first 15 days of treatment to determine the percentage of D2 receptors occupied by the medication. According to response, dosage was then adjusted to a maximum dosage of 20 mg daily of either drug. PET scans were repeated after 10 to 12 weeks of treatment. At the first PET scan, the 8 olanzapine-treated patients had significantly lower D2 receptor occupancies (mean 63.4%, SD 7.3) than those observed in the 10 patients treated with haloperidol (mean 73.0%, SD 6.1). When patients were rescanned following dosage adjustment, mean D2 receptor occupancies were greater than 70% in both groups. D2 receptor occupancies did not differ significantly between the olanzapine-treated group (mean 72.0%, SD 5.7) and the haloperidol-treated group (mean 78.7%, SD 7.6). These results suggest that, in patients being treated for a first episode of psychosis, olanzapine has its antipsychotic effect at approximately the same levels of D2 receptor occupancy as are achieved with low dosages of haloperidol.

  12. Reboxetine Enhances the Olanzapine-Induced Antipsychotic-Like Effect, Cortical Dopamine Outflow and NMDA Receptor-Mediated Transmission

    Marcus, Monica M; Jardemark, Kent; Malmerfelt, Anna; Björkholm, Carl; Svensson, Torgny H


    Preclinical data have shown that addition of the selective norepinephrine transporter (NET) inhibitor reboxetine increases the antipsychotic-like effect of the D2/3 antagonist raclopride and, in parallel, enhances cortical dopamine output. Subsequent clinical results suggested that adding reboxetine to stable treatments with various antipsychotic drugs (APDs) may improve positive, negative and depressive symptoms in schizophrenia. In this study, we investigated in rats the effects of adding reboxetine to the second-generation APD olanzapine on: (i) antipsychotic efficacy, using the conditioned avoidance response (CAR) test, (ii) extrapyramidal side effect (EPS) liability, using a catalepsy test, (iii) dopamine efflux in the medial prefrontal cortex and the nucleus accumbens, using in vivo microdialysis in freely moving animals and (iv) cortical N-methyl--aspartate (NMDA) receptor-mediated transmission, using intracellular electrophysiological recording in vitro. Reboxetine (6 mg/kg) enhanced the suppression of CAR induced by a suboptimal dose (1.25 mg/kg), but not an optimal (2.5 mg/kg) dose of olanzapine without any concomitant catalepsy. Addition of reboxetine to the low dose of olanzapine also markedly increased cortical dopamine outflow and facilitated prefrontal NMDA receptor-mediated transmission. Our data suggest that adjunctive treatment with a NET inhibitor may enhance the therapeutic effect of low-dose olanzapine in schizophrenia without increasing EPS liability and add an antidepressant action, thus in principle allowing for a dose reduction of olanzapine with a concomitant reduction of dose-related side effects, such as EPS and weight gain. PMID:20463659

  13. DU-AGG pilot plant design study

    Lessing, P.A.; Gillman, H.


    The Idaho National Engineering Laboratory (INEL) is developing new methods to produce high-density aggregate (artificial rock) primarily consisting of depleted uranium oxide. The objective is to develop a low-cost method whereby uranium oxide powder (UO[sub 2], U[sub 3]O[sub ]8, or UO[sub 3]) can be processed to produce high-density aggregate pieces (DU-AGG) having physical properties suitable for disposal in low-level radioactive disposal facilities or for use as a component of high-density concrete used as shielding for radioactive materials. A commercial company, G-M Systems, conducted a design study for a manufacturing pilot plant to process DU-AGG. The results of that study are included and summarized in this report. Also explained are design considerations, equipment capacities, the equipment list, system operation, layout of equipment in the plant, cost estimates, and the proposed plan and schedule

  14. Location Independent Professional Project: A Pilot Study

    Hudson, J.A.; Long, J.P.; Miller, M.M.


    This pilot study project explored the problem of providing access to the nomadic worker who desires to connect a computer through network access points at a number of different locations within the SNL/NM campus as well as outside the campus. The design and prototype development gathered knowledge that may allow a design to be developed that could be extended to a larger number of SNL/NM network drop boxes. The focus was to provide a capability for a worker to access the SNL IRN from a network drop box (e.g. in a conference room) as easily as when accessing the computer network from the office normally used by the worker. Additional study was done on new methods to authenticate the off campus worker, and protect and control access to data.

  15. The Pilot Staffing Conundrum: A Delphi Study


    Project, AFIT/ GMO /LAL/98J-2. School of Logistics and Acquisition Management, Air Force Institute of Technology (AU), Wright Patterson AFB, OH, June...Kafer, John H. Relationship of Airline Pilot Demand and Air Force Pilot Retention. Graduate Research Project, AFIT/ GMO /LAL/98J-11. School of Logistics

  16. The incidence of venous thromboembolism in commercial airline pilots: a cohort study of 2630 pilots.

    Kuipers, S; Venemans-Jellema, A; Cannegieter, S C; van Haften, M; Middeldorp, S; Büller, H R; Rosendaal, F R


    Airline pilots may be at increased risk of venous thromboembolism (VTE) because air travel has recently been established as a risk factor for VTE. The aim of this study was to assess the risk of VTE in a cohort of Dutch airline pilots. Airline pilots who had been active members of the Dutch aviation society (VNV) were questioned for the occurrence of VTE, presence of risk factors for VTE and number of flight hours per year and rank. Incidence rates among pilots were compared with those of the general Dutch population and with a population of frequently flying employees of multinational organizations. A total of 2630 male pilots were followed-up for a total of 20420 person-years (py). Six venous thromboses were reported, yielding an incidence rate of 0.3 per 1000 py. The standardized morbidity ratio, comparing these pilots with the general Dutch population adjusted for age, was 0.8. Compared with the international employee cohort, the standardized morbidity ratio was 0.7 when all employees were included and 0.6 when only the frequently travelling employees were included. The incidence rate did not increase with number of flight hours per year and did not clearly vary by rank. We conclude that the risk of VTE is not increased amongst airline pilots. © 2014 International Society on Thrombosis and Haemostasis.

  17. Weight loss during therapy with olanzapine orally disintegrating tablets: two case reports.

    Kozumplik, Oliver; Uzun, Suzana; Jakovljević, Miro


    The aim of this article is to report weight loss in patients with schizophrenia after switching from olanzapine standard oral tablet (SOT) to olanzapine orally disintegrating tablets (ODT). In the first case report, the patient was switched to olanzapine ODT in daily dosage of 20 mg, while in the second case report, the patient was switched to olanzapine ODT in daily dosage of 15 mg, and weight loss was similar (14 kg vs. 15 kg). Switching patients from olanzapine SOT to olanzapine ODT treatment resulted in significant weight loss that was maintained during 12 months in both case reports. Further controlled clinical investigations are necessary to evaluate change in weight during treatment with olanzapine ODT, and to improve our understanding of this change.

  18. Pilot study for natural radiation survey

    Brown, L.; Driscoll, C.M.H.; Green, B.M.R.; Miles, J.C.H.


    NRPB's national survey of natural radiation exposure in homes commenced in 1982 and will run until 1984. A pilot survey was undertaken in over 100 homes for one year, using passive thermoluminescent dosemeters to measure external radiation from terrestrial and cosmic sources and passive radon dosemeters to measure the radon-222 gas concentration. A preliminary analysis of the results obtained from the pilot survey is given. The main value of the pilot survey was in providing experience and various administrative and scientific procedures have been simplified or automated for the national survey. (U.K.)

  19. Olanzapine promotes fat accumulation in male rats by decreasing physical activity, repartitioning energy and increasing adipose tissue lipogenesis while impairing lipolysis.

    Albaugh, V L; Judson, J G; She, P; Lang, C H; Maresca, K P; Joyal, J L; Lynch, C J


    Olanzapine and other atypical antipsychotics cause metabolic side effects leading to obesity and diabetes; although these continue to be an important public health concern, their underlying mechanisms remain elusive. Therefore, an animal model of these side effects was developed in male Sprague-Dawley rats. Chronic administration of olanzapine elevated fasting glucose, impaired glucose and insulin tolerance, increased fat mass but, in contrast to female rats, did not increase body weight or food intake. Acute studies were conducted to delineate the mechanisms responsible for these effects. Olanzapine markedly decreased physical activity without a compensatory decline in food intake. It also acutely elevated fasting glucose and worsened oral glucose and insulin tolerance, suggesting that these effects are adiposity independent. Hyperinsulinemic-euglycemic clamp studies measuring (14)C-2-deoxyglucose uptake revealed tissue-specific insulin resistance. Insulin sensitivity was impaired in skeletal muscle, but either unchanged or increased in adipose tissue depots. Consistent with the olanzapine-induced hyperglycemia, there was a tendency for increased (14)C-2-deoxyglucose uptake into fat depots of fed rats and, surprisingly, free fatty acid (FFA) uptake into fat depots was elevated approximately twofold. The increased glucose and FFA uptake into adipose tissue was coupled with increased adipose tissue lipogenesis. Finally, olanzapine lowered fasting plasma FFA, and as it had no effect on isoproterenol-stimulated rises in plasma glucose, it blunted isoproterenol-stimulated in vivo lipolysis in fed rats. Collectively, these results suggest that olanzapine exerts several metabolic effects that together favor increased accumulation of fuel into adipose tissue, thereby increasing adiposity.

  20. Climatotherapy in Japan: a pilot study

    Kanayama, Hitomi; Kusaka, Yukinori; Hirai, Takayoshi; Inoue, Hiroyuki; Agishi, Yuko; Schuh, Angela


    Twenty-nine urban inhabitants participated in a half-day climatotherapy programme at the moderate mountain area and lowland area in the northwest part of the main island of Japan. The current study was aimed to investigate physically and mentally the objective and subjective influence of our short programme, which was a prospective pilot study of single intervention. Blood pressure was significantly descended during terrain cure at the uphill mountain path and returned after fresh-air rest cure, while there was no significant change throughout the programme at lowland flat path. Heart rate was significantly ascended and descended at both area, and more clearly changed at the mountain path. Profile of Mood Status brief form Japanese version administered before and after our half-day programme. Age adjusted T score of negative subscales, `tension-anxiety', `depression', `anger-hostility', `fatigue' and `confusion' were significantly lower after climatotherapy at both sites. Whereas, there was no significant change concerning `vigour' score. This short-version climatotherapy programme has been designed for people without enough time for long stay at health resort. It turned out our half-day climatotherapy programme contribute to mood status improvement. In addition, repeated practice of our short-version programme including endurance exercise with cool body shell using uphill path can be expected that blood pressure will go toward the normal range and heart rate will decrease both in usual time and during exercise. Therefore, health benefits can be expected of this climatotherapy programme.

  1. Pilot plant study for ethanol production

    Kim, J S [Korea Inst. of Science and Technology, Seoul (Korea, Republic of)


    Most of domestic alcohol fermentation factory adopt batch process of which productivity is lower than continuous fermentation process. They have made great effort to increase productivity by means of partial unit process automatization and process improvement with their accumulated experience but there is technical limitation in productivity of batch fermentation process. To produce and supply fuel alcohol, economic aspects must be considered first of all. Therefore, development of continuous fermentation process, of which productivity is high, is prerequisite to produce and use fuel alcohol but only a few foreign company possess continuous fermentation technic and use it in practical industrial scale fermentation. We constructed pilot plant (5 Stage CSTR 1 kl 99.5 v/v% ethanol/Day scale) to study some aspects stated below and our ultimate aims are production of industrial scale fuel alcohol and construction of the plant by ourselves. Some study concerned with energy saving separation and contamination control technic were entrusted to KAIST, A-ju university and KIST respectively. (author) 67 refs., 100 figs., 58 tabs.

  2. Setting a standard for electricity pilot studies

    Davis, Alexander L.; Krishnamurti, Tamar; Fischhoff, Baruch; Bruine de Bruin, Wandi


    In-home displays, dynamic pricing, and automated devices aim to reduce residential electricity use—overall and during peak hours. We present a meta-analysis of 32 studies of the impacts of these interventions, conducted in the US or Canada. We find that methodological problems are common in the design of these studies, leading to artificially inflated results relative to what one would expect if the interventions were implemented in the general population. Particular problems include having volunteer participants who may have been especially motivated to reduce their electricity use, letting participants choose their preferred intervention, and having high attrition rates. Using estimates of bias from medical clinical trials as a guide, we recalculate impact estimates to adjust for bias, resulting in values that are often less than half of those reported in the reviewed studies. We estimate that in-home displays were the most effective intervention for reducing overall electricity use (∼4% using reported data; ∼3% after adjusting for bias), while dynamic pricing significantly reduced peak demand (∼11% reported; ∼6% adjusted), especially when used in conjunction with home automation (∼25% reported; ∼14% adjusted). We conclude with recommendations that can improve pilot studies and the soundness of decisions based on their results. -- Highlights: •We conduct a meta-analysis of field studies of in-home displays, dynamic pricing, and automation on overall and peak use. •Studies were assessed and adjusted for risk-of-bias from inadequate experimental design. •Most studies were at high risk-of-bias from multiple sources. •In-home displays provided the best overall reduction in energy use, approximately 3% after adjustment for risk-of-bias. •Even after adjustment, automation approximately doubled the effectiveness of dynamic pricing on peak reduction from 6% to 14%

  3. Population pharmacokinetics analysis of olanzapine for Chinese psychotic patients based on clinical therapeutic drug monitoring data with assistance of meta-analysis.

    Yin, Anyue; Shang, Dewei; Wen, Yuguan; Li, Liang; Zhou, Tianyan; Lu, Wei


    The aim of this study was to build an eligible population pharmacokinetic (PK) model for olanzapine in Chinese psychotic patients based on therapeutic drug monitoring (TDM) data, with assistance of meta-analysis, to facilitate individualized therapy. Population PK analysis for olanzapine was performed using NONMEM software (version 7.3.0). TDM data were collected from Guangzhou Brain Hospital (China). Because of the limitations of TDM data, model-based meta-analysis was performed to construct a structural model to assist the modeling of TDM data as prior estimates. After analyzing related covariates, a simulation was performed to predict concentrations for different types of patients under common dose regimens. A two-compartment model with first-order absorption and elimination was developed for olanzapine oral tablets, based on 23 articles with 390 data points. The model was then applied to the TDM data. Gender and smoking habits were found to be significant covariates that influence the clearance of olanzapine. To achieve a blood concentration of 20 ng/mL (the lower boundary of the recommended therapeutic range), simulation results indicated that the dose regimen of olanzapine should be 5 mg BID (twice a day), ≥ 5 mg QD (every day) plus 10 mg QN (every night), or >10 mg BID for female nonsmokers, male nonsmokers and male smokers, respectively. The population PK model, built using meta-analysis, could facilitate the modeling of TDM data collected from Chinese psychotic patients. The factors that significantly influence olanzapine disposition were determined and the final model could be used for individualized treatment.

  4. Matrix-assisted laser-desorption/ionization mass spectrometric imaging of olanzapine in a single hair using esculetin as a matrix.

    Wang, Hang; Wang, Ying; Wang, Ge; Hong, Lizhi


    Matrix-assisted laser desorption/ionization-mass spectrometric imaging (MALDI-MSI) for the analysis of intact hair is a powerful tool for monitoring changes in drug consumption. The embedding of a low drug concentration in the hydrophobic hair matrix makes it difficult to extract and detect, and requires an improved method to increase detection sensitivity. In this study, an MSI method using MALDI-Fourier transform ion cyclotron resonance was developed for direct identification and imaging of olanzapine in hair samples using the positive ion mode. Following decontamination, scalp hair samples from an olanzapine user were scraped from the proximal to the distal end three times, and 5mm hair sections were fixed onto an Indium-Tin-Oxide (ITO)-coated microscopic glass slide. Esculetin (6,7-dihydroxy-2H-chromen-2-one) was used as a new hydrophobic matrix to increase the affinity, extraction and ionization efficiency of olanzapine in the hair samples. The spatial distribution of olanzapine was observed using five single hairs from the same drug user. This matrix improves the affinity of olanzapine in hair for molecular imaging with mass spectrometry. This method may provide a detection power for olanzapine to the nanogram level per 5mm hair. Time course changes in the MSI results were also compared with quantitative HPLC-MS/MS for each 5mm segment of single hair shafts selected from the MALDI target. MALDI imaging intensities in single hairs showed good semi-quantitative correlation with the results from conventional HPLC-MS/MS. MALDI-MSI is suitable for monitoring drug intake with a high time resolution. Copyright © 2017 Elsevier B.V. All rights reserved.

  5. Anti-depressive effectiveness of olanzapine, quetiapine, risperidone and ziprasidone: a pragmatic, randomized trial

    Løberg Else-Marie


    Full Text Available Abstract Background Efficacy studies indicate anti-depressive effects of at least some second generation antipsychotics (SGAs. The Bergen Psychosis Project (BPP is a 24-month, pragmatic, industry-independent, randomized, head-to-head comparison of olanzapine, quetiapine, risperidone and ziprasidone in patients acutely admitted with psychosis. The aim of the study is to investigate whether differential anti-depressive effectiveness exists among SGAs in a clinically relevant sample of patients acutely admitted with psychosis. Methods Adult patients acutely admitted to an emergency ward for psychosis were randomized to olanzapine, quetiapine, risperidone or ziprasidone and followed for up to 2 years. Participants were assessed repeatedly using the Positive and Negative Syndrome Scale - Depression factor (PANSS-D and the Calgary Depression Scale for Schizophrenia (CDSS. Results A total of 226 patients were included. A significant time-effect showing a steady decline in depressive symptoms in all medication groups was demonstrated. There were no substantial differences among the SGAs in reducing the PANSS-D score or the CDSS sum score. Separate analyses of groups with CDSS sum scores > 6 or ≤6, respectively, reflecting degree of depressive morbidity, revealed essentially identical results to the primary analyses. There was a high correlation between the PANSS-D and the CDSS sum score (r = 0.77; p Conclusions There was no substantial difference in anti-depressive effectiveness among olanzapine, quetiapine, risperidone or ziprasidone in this clinically relevant sample of patients acutely admitted to hospital for symptoms of psychosis. Based on our findings we can make no recommendations concerning choice of any particular SGA for targeting symptoms of depression in a patient acutely admitted with psychosis. Trial Registration ID; URL: NCT00932529

  6. Uranium-contaminated soil pilot treatment study

    Turney, W.R.J.R.; Mason, C.F.V.; Michelotti, R.A.


    A pilot treatment study is proving to be effective for the remediation of uranium-contaminated soil from a site at the Los Alamos National Laboratory by use of a two-step, zero-discharge, 100% recycle system. Candidate uranium-contaminated soils were characterized for uranium content, uranium speciation, organic content, size fractionization, and pH. Geochemical computer codes were used to forecast possible uranium leach scenarios. Uranium contamination was not homogenous throughout the soil. In the first step, following excavation, the soil was sorted by use of the ThemoNuclean Services segmented gate system. Following the sorting, uranium-contaminated soil was remediated in a containerized vat leach process by use of sodium-bicarbonate leach solution. Leach solution containing uranium-carbonate complexes is to be treated by use of ion-exchange media and then recycled. Following the treatment process the ion exchange media will be disposed of in an approved low-level radioactive landfill. It is anticipated that treated soils will meet Department of Energy site closure guidelines, and will be given open-quotes no further actionclose quotes status. Treated soils are to be returned to the excavation site. A volume reduction of contaminated soils will successfully be achieved by the treatment process. Cost of the treatment (per cubic meter) is comparable or less than other current popular methods of uranium-contamination remediation

  7. The Citizenship Safety Project: a pilot study.

    Frederick, K; Barlow, J


    The Government White Paper Saving Lives: Our Healthier Nation (1999) provides a clear indication that accidents are a serious public health problem and have been targeted by the Department of Health as a key area for prevention over the next 10 years. School-based injury prevention programmes have been identified as one of the key settings for the implementation of the White Paper's heath promotion strategies. The Citizen Safety Project (CSP) is a peer-delivered injury prevention programme for Year 10 students (14-15 years) and Year 2 pupils (6-7 years). This paper summarizes the findings of a pilot study that assessed the feasibility of implementing the CSP in schools and of conducting a larger study. Working as part of their Personal Social Health Education lessons, 11 pairs (n = 22) of Year 10 students developed a project to take one accident prevention theme of their choice into a primary school to teach small groups of five or six Year 2 pupils (n = 55). A formative evaluation was conducted, based on interviews with Year 2 and Year 10 teachers (n = 2), and the diaries of Year 10 students. Knowledge of accident prevention and risk awareness was measured in Year 2 pupils using the Draw and Write technique, and impact on Year 10 students was measured using self-esteem and locus of control inventories. Using both statistical and thematic analysis the study concludes that the CSP is well accepted, improves knowledge in Year 2 pupils and boosts confidence in Year 10 students, while concurrently achieving key stage attainment targets. Implications of the study are discussed in terms of future research, as are recommendations with regard to modifications to the project.

  8. Experiences from the ITRAP pilot study

    Schmitzer, C.; Beck, P.


    Illicit trafficking and inadvertent movement of nuclear and other radioactive materials is not a new phenomenon. However, concern about such activities has increased remarkably in the last decade. Although the number of such incidents has risen, the overall extent of the problem is not restricted to Europe and not to nuclear proliferation. A few percent of these incidents involve so-called 'special nuclear materials', which may be used for nuclear weapons and therefore cause a threat of nuclear proliferation. The vast majority of these incidents, however, involve radioactive sources, low-enriched, natural or depleted uranium, which are not usable for weapons. There have been instances in which loss of control over radioactive materials has led to serious, even fatal, consequences to persons. Examples include unintentional incorporation of radioactive materials into recycled steel, recovery of lost radioactive sources by unsuspecting individuals, and deliberate purloining of radioactive material. The ITRAP project - financed by the Austrian Government and executed by the Austrian Research Center in close cooperation with the IAEA, World Customs Organisation (WCO) and Interpol - aimed at finding international consensus on specifications for detection equipment and instrumentation as well as verification of such specifications in laboratory tests and field installations. Under the umbrella of the pilot study, 23 international companies participated in the study and many of them devised improvements of their monitoring equipment. An important element of this study was the harmonized establishment of detection thresholds for practical implementation at borders or similar checkpoints. However, equally important was the verification of agreed specifications in controlled laboratory conditions and in realistic operating environments (field tests). All crucial parameters, as inter alia the false alarm rate, were verified by a significant testing effort as compared to

  9. Olanzapine treatment for tics in an adult woman with severe tourette syndrome.

    Hwang, Wen-Juh


    Olanzapine had been reported to be effective in the control of tics in a few adult female patients who had a short follow-up period. The author reports the successful outcome of long-term olanzapine treatment in an adult woman with severe Tourette syndrome. A 33-year-old woman who had severe motor and vocal tics (Modified Rush Videotape Rating Scale: 17/20) showed an excellent response to olanzapine 10 mg/day within 2 months. Her tic symptoms were well controlled with gradual reduction of her dose of olanzapine to 2.5 mg/day during the following 8 years. She was symptom-free without medications in the past 2 years. In addition, she had a normal menstrual cycle and became pregnant during the period of olanzapine treatment. Olanzapine may be the drug of first choice for treating severe Tourette syndrome in pubescent female adolescents and young women who wish to have children.

  10. ORIGINAL ARTICLE ORIG ORIGI A pilot study evaluating erect chest ...


    Nov 19, 2009 ... South African Tuberculosis Vaccine Initiative, Institute of Infectious Diseases ... After obtaining consent from departmental and institutional ethics com- mittees, a pilot study ... informed consent from parents or legal guardians.

  11. Answering Fixed Response Items in Chemistry: A Pilot Study.

    Hateley, R. J.


    Presents a pilot study on student thinking in chemistry. Verbal comments of a group of six college students were recorded and analyzed to identify how each student arrives at the correct answer in fixed response items in chemisty. (HM)

  12. Pilot Study: Foam Wedge Chin Support Static Tolerance Testing


    AFRL-SA-WP-SR-2017-0026 Pilot Study: Foam Wedge Chin Support Static Tolerance Testing Austin M. Fischer, BS1; William W...COVERED (From – To) April – October 2017 4. TITLE AND SUBTITLE Pilot Study: Foam Wedge Chin Support Static Tolerance Testing 5a. CONTRACT NUMBER...PROJECT NUMBER 5e. TASK NUMBER 5f. WORK UNIT NUMBER 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) USAF School of Aerospace

  13. Ziprasidone vs olanzapine in recent-onset schizophrenia and schizoaffective disorder: results of an 8-week double-blind randomized controlled trial

    Grootens, K.P.; Veelen, N.M. van; Peuskens, J.; Sabbe, B.G.C.; Thys, E.; Buitelaar, J.K.; Verkes, R.J.; Kahn, R.S.


    INTRODUCTION: Head-to-head comparisons of antipsychotics have predominantly included patients with chronic conditions. The aim of the present study was to compare the efficacy and tolerability of ziprasidone and olanzapine in patients with recent-onset schizophrenia. METHODS: The study was an

  14. Ziprasidone Vs Olanzapine in Recent-Onset Schizophrenia and Schizoaffective Disorder : Results of an 8-Week Double-Blind Randomized Controlled Trial

    Grootens, K. P.; van Veelen, N. M. J.; Peuskens, J.; Sabbe, B. G. C.; Thys, E.; Buitelaar, J. K.; Verkes, R. J.; Kahn, R. S.

    Introduction: Head-to-head comparisons of antipsychotics have predominantly included patients with chronic conditions. The aim of the present study was to compare the efficacy and tolerability of ziprasidone and olanzapine in patients with recent-onset schizophrenia. Methods: The study was an

  15. Glucagon receptor knockout mice are protected against acute olanzapine-induced hyperglycemia.

    Castellani, Laura N; Peppler, Willem T; Sutton, Charles D; Whitfield, Jamie; Charron, Maureen J; Wright, David C


    To determine if glucagon is involved in mediating the increase in blood glucose levels caused by the second-generation antipsychotic drug olanzapine. Whole body glucagon receptor deficient mice (Gcgr -/- ) or WT littermate controls were injected with olanzapine (5mg/kg BW IP) and changes in blood glucose measured over the following 120min. Separate cohorts of mice were treated with olanzapine and changes in pyruvate tolerance, insulin tolerance and whole body substrate oxidation were determined. Olanzapine treatment increased serum glucagon and lead to rapid increases in blood glucose concentrations in WT mice. Gcgr -/- mice were protected against olanzapine-induced increases in blood glucose but this was not explained by differences in terminal serum insulin concentrations, enhanced AKT phosphorylation in skeletal muscle, adipose tissue or liver or differences in RER. In both genotypes olanzapine induced an equivalent degree of insulin resistance as measured using an insulin tolerance test. Olanzapine treatment led to an exaggerated glucose response to a pyruvate challenge in WT but not Gcgr -/- mice and this was paralleled by reductions in the protein content of PEPCK and G6Pase in livers from Gcgr -/- mice. Gcgr -/- mice are protected against olanzapine-induced increases in blood glucose. This is likely a result of reductions in liver glucose output, perhaps secondary to decreases in PEPCK and G6Pase protein content. Our findings highlight the central role of the liver in mediating olanzapine-induced disturbances in glucose homeostasis. Copyright © 2017 Elsevier Ltd. All rights reserved.

  16. Placebo-controlled trial of atomoxetine for weight reduction in people with schizophrenia treated with clozapine or olanzapine.

    Ball, M Patricia; Warren, Kimberly R; Feldman, Stephanie; McMahon, Robert P; Kelly, Deanna L; Buchanan, Robert W


    In recent years, several pharmacological and psychosocial interventions have examined ways to prevent or treat weight gain in people receiving second-generation antipsychotics. While there has been some success, in general, results have not been compelling. Atomoxetine is a selective norepinepherine reuptake inhibitor found to be associated with appetite suppression. Therefore, we examined whether atomoxetine may be of benefit for those who have gained weight on either clozapine or olanzapine. The study was a double-blind, placebo-controlled trial. All participants received the same psychosocial platform: a structured support and exercise group. People with schizophrenia or schizoaffective disorder, on olanzapine or clozapine, who had gained at least 7% of their pre-clozapine or pre-olanzapine weight were eligible for a 24-week, randomized, parallel group, double-blind comparison of adjunctive atomoxetine or placebo. Thirty-seven participants (20 atomoxetine, 17 placebo) were randomized and 26 participants (14 atomoxetine, 12 placebo; 70.2%) completed the study. There were no significant group differences in baseline BMI (atomoxetine: 34.5±4.9; placebo: 35.7±7.0) or weight (atomoxetine: 102.2±15.7 kg; placebo: 104.3±17.5 kg). Both treatment groups showed modest, not significant, trends in weight loss, averaging about 2 kg. Gender or baseline antipsychotic treatment did not modify treatment effects on weight. Secondary outcomes included neuropsychological assessments, symptom assessments (BPRS, SANS) and safety assessments. Of these, only the group difference in Gordon distractibility test scores was statistically significant and favored treatment with atomoxetine. Atomoxetine is not effective for weight loss in this population, but both olanzapine and clozapine participants can lose weight with structured group support and exercise.


    This document is a project plan for a pilot study at the United Chrome NPL site, Corvallis, Oregon and includes the health and safety and quality assurance/quality control plans. The plan reports results of a bench-scale study of the treatment process as iieasured by the ...

  18. Evaluation of antidepressant like property of amisulpride per se and its comparison with fluoxetine and olanzapine using forced swimming test in albino mice.

    Pawar, Ganesh R; Agrawal, Rajendra P; Phadnis, Pradeep; Paliwal, Abhay; Vyas, Savita; Solanki, Pooja


    Amisulpride, an atypical antipsychotic was evaluated for antidepressant like activity in forced swimming test in Swiss albino mice. The effect of amisulpride was compared with that of fluoxetine, the standard antidepressant and olanzapine, another atypical antipsychotic claimed to have antidepressant like activity. Both acute and chronic studies were carried out. In both the studies, animals were divided into four groups (n = 8 each) and subjected to oral drug interventions as follows -- Group 1- control (distilled water, 1 mL/kg); Group 2- fluoxetine in a dose of 10 mg/kg 23.5, 5 and 1 h before the test; Group 3-amisulpride in a dose of 70 mg/kg 23.5, 5 and 1 h before the test; Group 4- olanzapine in a dose of 2 mg/kg 23.5, 5 and 1 h before the study. In the chronic study, the treatment was given daily for 28 days with last dose being given 2 h prior to the test. A time sampling method was used to score the behavioral activity in each group. Results of both the studies indicated that animals given amisulpride displayed significant improvement in swimming behavior (p Fluoxetine also showed significant difference in activity as compared to amisulpride and olanzapine (p swimming phases in albino mice (p > 0.05). We conclude that amisulpride per se has an antidepressant like activity comparable to that of olanzapine though the activity was significantly less than that of fluoxetine.

  19. Cardiac Auscultation Using Smartphones: Pilot Study.

    Kang, Si-Hyuck; Joe, Byunggill; Yoon, Yeonyee; Cho, Goo-Yeong; Shin, Insik; Suh, Jung-Won


    Cardiac auscultation is a cost-effective, noninvasive screening tool that can provide information about cardiovascular hemodynamics and disease. However, with advances in imaging and laboratory tests, the importance of cardiac auscultation is less appreciated in clinical practice. The widespread use of smartphones provides opportunities for nonmedical expert users to perform self-examination before hospital visits. The objective of our study was to assess the feasibility of cardiac auscultation using smartphones with no add-on devices for use at the prehospital stage. We performed a pilot study of patients with normal and pathologic heart sounds. Heart sounds were recorded on the skin of the chest wall using 3 smartphones: the Samsung Galaxy S5 and Galaxy S6, and the LG G3. Recorded heart sounds were processed and classified by a diagnostic algorithm using convolutional neural networks. We assessed diagnostic accuracy, as well as sensitivity, specificity, and predictive values. A total of 46 participants underwent heart sound recording. After audio file processing, 30 of 46 (65%) heart sounds were proven interpretable. Atrial fibrillation and diastolic murmur were significantly associated with failure to acquire interpretable heart sounds. The diagnostic algorithm classified the heart sounds into the correct category with high accuracy: Galaxy S5, 90% (95% CI 73%-98%); Galaxy S6, 87% (95% CI 69%-96%); and LG G3, 90% (95% CI 73%-98%). Sensitivity, specificity, positive predictive value, and negative predictive value were also acceptable for the 3 devices. Cardiac auscultation using smartphones was feasible. Discrimination using convolutional neural networks yielded high diagnostic accuracy. However, using the built-in microphones alone, the acquisition of reproducible and interpretable heart sounds was still a major challenge. NCT03273803; (Archived by WebCite at

  20. Acute camptocormia induced by olanzapine: a case report

    Boyer Stéphane


    Full Text Available Abstract Introduction Camptocormia refers to an abnormal posture with flexion of the thoraco-lumbar spine which increases during walking and resolves in supine position. This symptom is an increasingly recognized feature of parkinsonian and dystonic disorders, but may also be caused by neuromuscular diseases. There is recent evidence that both central and peripheral mechanisms may be involved in the pathogenesis of camptocormia. We report a case of acute onset of camptocormia, a rare side effect induced by olanzapine, a second-generation atypical anti-psychotic drug with fewer extra-pyramidal side-effects, increasingly used as first line therapy for schizophrenia, delusional disorders and bipolar disorder. Case presentation A 73-year-old Caucasian woman with no history of neuromuscular disorder, treated for chronic delusional disorder for the last ten years, received two injections of long-acting haloperidol. She was then referred for fatigue. Physical examination showed a frank parkinsonism without other abnormalities. Routine laboratory tests showed normal results, notably concerning creatine kinase level. Fatigue was attributed to haloperidol which was substituted for olanzapine. Our patient left the hospital after five days without complaint. She was admitted again three days later with acute back pain. Examination showed camptocormia and tenderness in paraspinal muscles. Creatine kinase level was elevated (2986 UI/L. Magnetic resonance imaging showed necrosis and edema in paraspinal muscles. Olanzapine was discontinued. Pain resolved quickly and muscle enzymes were normalized within ten days. Risperidone was later introduced without significant side-effect. The camptocormic posture had disappeared when the patient was seen as an out-patient one year later. Conclusions Camptocormia is a heterogeneous syndrome of various causes. We believe that our case illustrates the need to search for paraspinal muscle damage, including drug

  1. Olanzapine for chemotherapy-induced nausea and vomiting: systematic review and meta-analysis

    Chelkeba L


    Full Text Available Background: Chemotherapy induced nausea and vomiting (CINV remains the most distressing event in patients receiving highly emetogenic chemotherapy (HEC or moderately emetogenic chemotherapy (MEC. Objective: Therefore, this meta-analysis was conducted to evaluate the efficacy of olanzapine containing regimen in preventing acute, delayed and overall phases of CINV. Methods: PubMed, EBSCO, and Cochrane central register of controlled trials electronic databases were searched to identify RCTs that compared the effects of olanzapine with non-olanzapine regimen in preventing CINV. Randomized clinical trials (RCTs that compared olanzapine containing regimen with non-olanzapine regimen were included. The primary outcomes were the percentage of patients achieving no vomiting or no nausea in acute, delayed and overall phases. Results: 13 RCTs that enrolled 1686 participants were included in this meta-analysis. 852 patients were assigned to olanzapine and 834 patients were assigned to non-olanzapine regimen (other standard antiemetic regimen. The percentages of no emesis achieved were 87.5%, 76.2%, 73.6% in olanzapine versus 76.7%, 61.8%, and 56.4% in non-olanzapine regimen in acute, delayed and overall phases, respectively. The percentages of no nausea were 82%, 64.3%, 61.6% in olanzapine group versus 71.3%, 41.8%, and 40.6% in non-olanzapine group in acute, delayed and overall phases, respectively. In general, olanzapine containing regimen achieved statistical superiority to non-olanzapine regimen in no vomiting endpoint in acute phase (OR 2.16; 95%CI 1.60 to 2.91, p<0.00001; I-square=5%; p=0.40, delayed phase (OR 2.28; 95%CI 1.1.46 to 3.54, p=0.0003; I-square=65%; p=0.001 and overall phase (OR 2.48; 95%CI 1.59 to 3.86, p<0.0001; I-square=69%; p< 0.0001. Conclusion: The current meta-analysis showed that olanzapine was statistically and clinically superior to non-olanzapine regimen in preventing CINV in most domains of the parameters.

  2. Predictors of continuation with olanzapine during the 1-year naturalistic treatment of patients with schizophrenia in Japan

    Ye W


    Full Text Available Wenyu Ye1, Haya Ascher-Svanum2, Yuka Tanji3, Jennifer A Flynn3, Michihiro Takahashi3,41Lilly Suzhou Pharmaceutical Co, Shanghai, People’s Republic of China; 2Eli Lilly and Company, Indianapolis, IN, USA; 3Lilly Research Laboratories Japan, Eli Lilly Japan KK, Kobe, 4Terauchi-Takahashi Psychiatric Clinic, Ashiya, JapanPurpose: Treatment continuation is considered an important measure of antipsychotic effectiveness in schizophrenia, reflecting the medication’s efficacy, safety, and tolerability from both patients’ and clinicians’ perspectives. This study identified characteristics of patients with schizophrenia who continue olanzapine therapy for a 1-year period in Japan.Methods: In a large (N = 1850, prospective, observational study, Japanese patients with schizophrenia who initiated treatment with olanzapine were followed for 1 year. Baseline characteristics were compared using t-tests and chi-square tests. Stepwise logistic regression was used to identify independent baseline predictors of treatment continuation.Results: Most patients (68.2% continued with olanzapine therapy for the full 1-year study period, with an average duration of 265.5 ± 119.4 days. At baseline, patients who continued were significantly more likely to be male, older, and inpatients; have longer illness duration, higher negative and cognitive symptoms, better health-related quality of life, and prior anticholinergic use. Continuers were significantly less likely to engage in social activities, live independently, work for pay, or have prior antidepressant use. Continuers showed significantly greater early (3-month improvement in global symptom severity. Logistic regression found that continuation was significantly predicted by longer illness duration, lower positive symptoms, higher negative symptoms, and better health-related quality of life.Conclusions: In this large naturalistic study in Japan, most patients with schizophrenia stayed on olanzapine therapy for

  3. A mixed method pilot study: the researchers' experiences.

    Secomb, Jacinta M; Smith, Colleen


    This paper reports on the outcomes of a small well designed pilot study. Pilot studies often disseminate limited or statistically meaningless results without adding to the body knowledge on the comparative research benefits. The design a pre-test post-test group parallel randomised control trial and inductive content analysis of focus group transcripts was tested specifically to increase outcomes in a proposed larger study. Strategies are now in place to overcome operational barriers and recruitment difficulties. Links between the qualitative and quantitative arms of the proposed larger study have been made; it is anticipated that this will add depth to the final report. More extensive reporting on the outcomes of pilot studies would assist researchers and increase the body of knowledge in this area.

  4. Orally disintegrating olanzapine and potential differences in treatment-emergent weight gain

    Karagianis, Jamie; Hoffmann, Vicki Poole; Arranz, Belen; Treuer, Tamás; Maguire, Gerald A.; de Haan, Lieuwe; Chawla, Bharat


    Several papers and communications have reported possible weight reduction or less weight gain when patients start or switch to orally disintegrating olanzapine, as contrasted with standard oral olanzapine tablets. In this paper, the current literature is reviewed and hypothesized mechanisms of

  5. Evaluation of the efficacy and safety of olanzapine as an adjunctive treatment for anorexia nervosa in adolescent females: a randomized, double-blind, placebo-controlled trial

    Moher David


    Full Text Available Abstract Background Anorexia Nervosa (AN is a serious, debilitating condition that causes significant physical, emotional, and functional impairment. The condition is characterized by destructive weight loss behaviours and a refusal to maintain body weight at or above a minimally normal weight for age and height. AN often develops in adolescence and is a predominantly female disorder. Treatment for AN typically involves medical, nutritional and psychological interventions. Pharmacotherapy is also often used; however, the literature on the effectiveness of these drugs in a pediatric population is very limited. Olanzapine, which is an 'atypical' antipsychotic, is becoming more widespread in the treatment of AN. Olanzapine is hypothesized to facilitate weight gain, while decreasing levels of agitation and decreasing resistance to treatment in young women with AN. This randomized, double-blind placebo-controlled trial seeks to examine the effectiveness and safety of olanzapine in female youth with AN. Methods/Design Adolescent females between the ages of 12 and 17 diagnosed with AN (either restricting or binge/purge type or Eating Disorder Not Otherwise Specified with a Body Mass Index of less than or equal to 17.5, will be offered inclusion in the study. Patients will be randomly assigned to receive either olanzapine or placebo. Patients assigned to receive olanzapine will start at a low dose of 1.25 mg/day for three days, followed by 2.5 mg/day for four days, 5 mg/day for one week, then 7.5 mg/day (the target dose chosen for 10 weeks. After 10 weeks at 7.5 mg the medication will be tapered and discontinued over a period of two weeks. The effectiveness of olanzapine versus placebo will be determined by investigating the change from baseline on measures of eating attitudes and behaviors, depression and anxiety, and change in Body Mass Index at week 12, and after a follow-up period at week 40. It is anticipated that 67 participants will be recruited

  6. 77 FR 12312 - Electronic Submission of Nonclinical Study Data; Notice of Pilot Project


    ...] Electronic Submission of Nonclinical Study Data; Notice of Pilot Project AGENCY: Food and Drug Administration... and Research (CBER) is announcing an invitation to participate in a pilot evaluation program to test.... Participation in the pilot program is open to all sponsors. The pilot program is intended to provide industry...

  7. Pilot studies: one swallow does not make a summer... Editorial

    Gelder, T. van; Smits, P.


    What should we expect from pilot studies, done in small series of patients? In the literature there are many examples of small studies with very promising results, that in subsequent larger or better controlled studies proved to be much less promising, or even disastrous. In some instances the

  8. Pilot study approach and qualification dossier components

    Ammirato, F.; Ashwin, P.


    The aim of the Pilot Project is to evaluate the IAEA Guidelines and methodology for the benefit of IAEA Member States trough a simulation of qualification activities. The Project is based on a real component and available data - NPP Kozloduy unit 5, weld 3. The initial phase is limited to the Qualification dossier. The Project relies on the input from the team members and Member States. Team organization and responsibilities are presented. The components of the Qualification Dossier (technical specification, inspection procedure and preliminary review, qualification procedure) and their current status are also presented. A comparison is done with their qualification programs. The characteristics of performance demonstrations are discussed. The results show that the teamwork has been successful and the IAEA methodology covers all situations. It is expected that the End Project will become 'Benchmark's' for future qualification activities

  9. Intramuscular olanzapine versus intramuscular haloperidol plus lorazepam for the treatment of acute schizophrenia with agitation: An open-label, randomized controlled trial.

    Huang, Charles Lung-Cheng; Hwang, Tzung-Jeng; Chen, Yi-Hsing; Huang, Guan-Hua; Hsieh, Ming H; Chen, Hsiu-Hsi; Hwu, Hai-Gwo


    To compare the efficacy and safety profile between intramuscular (IM) olanzapine and IM haloperidol plus IM lorazepam in acute schizophrenic patients with moderate to severe agitation. This was a prospective, randomized, open-label study. Acutely agitated patients with schizophrenia or schizoaffective disorder (n = 67) were randomized to receive 10 mg IM olanzapine (n = 37) or 5 mg IM haloperidol plus 2 mg IM lorazepam (n = 30). Agitation was measured with Positive and Negative Syndrome Scale Excited Component (PANSS-EC) and Agitation-Calmness Evaluation Scale (ACES) during the first 2 hours and at 24 hours after the first injection. Safety was assessed using the Simpson-Angus Scale and Barnes Akathisia Rating Scale and by recording adverse events at 24 hours following the first injection. The Clinical Global Impression-Severity scale was also rated. The PANSS-EC scores decreased significantly at 2 hours after the first injection in both groups (olanzapine: -10.2, p haloperidol + lorazepam: -9.9, p Haloperidol plus lorazepam was not inferior to olanzapine in reducing agitation at 2 hours. There were no significant differences in PANSS-EC or ACES scores between the two groups within 2 hours following the first injection. The frequencies of adverse events and changes in Clinical Global Impression-Severity, Simpson-Angus Scale, and Barnes Akathisia Rating Scale scores from baseline to 24 hours showed no significant differences between the groups. The findings suggest that IM haloperidol (5 mg) plus lorazepam (2 mg) is not inferior to IM olanzapine (10 mg) in the treatment of acute schizophrenic patients with moderate to severe agitation ( identifier number NCT00797277). Copyright © 2015. Published by Elsevier B.V.

  10. Converging evidence for the association of functional genetic variation in the serotonin receptor 2a gene with prefrontal function and olanzapine treatment.

    Blasi, Giuseppe; De Virgilio, Caterina; Papazacharias, Apostolos; Taurisano, Paolo; Gelao, Barbara; Fazio, Leonardo; Ursini, Gianluca; Sinibaldi, Lorenzo; Andriola, Ileana; Masellis, Rita; Romano, Raffaella; Rampino, Antonio; Di Giorgio, Annabella; Lo Bianco, Luciana; Caforio, Grazia; Piva, Francesco; Popolizio, Teresa; Bellantuono, Cesario; Todarello, Orlando; Kleinman, Joel E; Gadaleta, Gemma; Weinberger, Daniel R; Bertolino, Alessandro


    Serotonin (5-hydroxytryptamine) receptor 2a (5-HT2AR) signaling is important for modulation of corticostriatal pathways and prefrontal activity during cognition. Furthermore, newer antipsychotic drugs target 5-HT2AR. A single-nucleotide polymorphism in the 5-HT2AR gene (HTR2A rs6314, C>T; OMIM 182135) has been weakly associated with differential 5-HT2AR signaling and with physiologic as well as behavioral effects. To use a hierarchical approach to determine the functional effects of this single-nucleotide polymorphism on 5-HT2AR messenger RNA and protein expression, on prefrontal phenotypes linked with genetic risk for schizophrenia, and on treatment with olanzapine. In silico predictions, in vitro, and case-control investigations. Academic and clinical facilities. The postmortem study included 112 brains from healthy individuals; the in vivo investigation included a total sample of 371 healthy individuals and patients with schizophrenia. EXPOSURES Patients received olanzapine monotherapy for 8 weeks. In silico predictions, messenger RNA, and protein expression in postmortem human prefrontal cortex and HeLa cells, functional magnetic resonance imaging prefrontal activity and behavior during working memory and attention in healthy individuals, and response to an 8-week trial of olanzapine treatment in patients with schizophrenia. Bioinformatic analysis predicted that rs6314 alters patterns of splicing, with possible effects on HTR2A expression. Moreover, the T allele was associated with reduced prefrontal messenger RNA expression in postmortem prefrontal cortex, with reduced protein expression in vitro, inefficient prefrontal blood oxygen level-dependent functional magnetic resonance imaging response during working memory and attentional control processing, and impaired working memory and attention behavior, as well as with attenuated improvement in negative symptoms after olanzapine treatment. Our results suggest that HTR2A rs6314 affects 5-HT2AR expression and

  11. Attitudes Toward Guarani and Spanish: A Pilot Study in Paraguay.

    Rhodes, Nancy C.

    This study analyzes the language attitudes of the Paraguayan people toward their two languages, Guarani and Spanish. To study the bilingual situation in the South American country, a pilot survey was carried out in the capital city addressing the major topics of language attitudes, language usage, and language varieties. The goals of the survey…

  12. Technical Writing Redesign and Assessment: A Pilot Study

    Winter, Gaye Bush


    The purpose of this study was to compare scores on writing assignments from traditional, fully online courses in technical writing to pilot, hybrid courses at a southern university. A total of 232 students' assignments were compared in this study. All writing assignments were scored by six trained instructors of English using the same five point…

  13. Indonesian EFL Students' Perspective on Writing Process: A Pilot Study

    Hermilinda Abas, Imelda; Aziz, Noor Hashima Abd


    The study was aimed at understanding the EFL Indonesian students' perspective on the writing process. The pilot study involved two male Indonesian postgraduate students in Universiti Utara Malaysia. The Indonesian students were selected based on the following criteria: (1) had enough knowledge in English writing, indicated by the completion of…

  14. Forces exerted by jumping children: A pilot study

    Moes, C.C.M.; Bakker, H.E.


    This article reports on a pilot study of the loads exerted vertically by children when jumping. The subjects of the study were 17 children, aged from two to twelve years. Measurements were made using video recordings and a force-plate. The influence of the stiffness of the base and of jumping with

  15. Clean indoor air increases physical independence : a pilot study

    Snijders, M.C.L.; Koren, L.G.H.; Kort, H.S.M.; Bronswijk, van J.E.M.H.


    Clean indoor air enhances health. In a pilot study, we examined whether a good indoor air quality increases the activity potential of older persons with chronic lung disease. Five older persons were studied while performing kitchen activities. Body movement and heart rate were monitored.

  16. Combination use of atomoxetine hydrochloride and olanzapine in the treatment of attention-deficit/hyperactivity disorder with comorbid disruptive behavior disorder in children and adolescents 10-18 years of age.

    Holzer, Barry; Lopes, Vasco; Lehman, Robert


    The aim of this study was to assess the use of atomoxetine and olanzapine in combination to treat attention-deficit/hyperactivity disorder (ADHD) and comorbid disruptive behaviors in children and adolescents 10-18 years of age. Eleven subjects ages 10-18 received open-label atomoxetine and olanzapine for a 10 week treatment period. Patients were assessed at baseline, 2 weeks, 4 weeks, 6 weeks, and 10 weeks (posttreatment). ADHD improvement was measured through the ADHD Rating Scale (ADHD-RS) (Investigator and Parent ratings). Aggression was measured through the Modified Overt Aggression Scale (MOAS). The combined use of atomoxetine and olanzapine resulted in statistically significant improvement in ADHD symptoms and overt aggression from baseline to posttreatment. As evidenced by a 33% reduction in symptoms on the ADHD-RS-I and the MOAS, 73% of patients were considered responders to ADHD treatment, whereas 55% responded to treatment for aggression. Both medications were generally well tolerated. Olanzapine treatment was associated with significant weight gain. Patients gained, on average, 3.9 kg. throughout the treatment period. These data provide initial evidence that combination use of atomoxetine and olanzapine for the treatment of ADHD and comorbid disruptive behaviors was effective in reducing ADHD symptoms and aggressive behavior in a 10 week treatment period.

  17. Severe ischemic colitis following olanzapine use: a Case Report

    Samuel Raimundo Fernandes

    Full Text Available Ischemic colitis is the most common subtype of intestinal ischemia usually resulting from vasospasm, vessel occlusion or mesenteric hypoperfusion. Neuroleptics have seldom been linked to ischemic colitis by blocking peripheral anticholinergic and antiserotonergic receptors inducing severe gastrointestinal paresis. We report a young patient with severe ischemic colitis requiring surgery due to necrosis of the bowel. After exclusion of other potential causes, olanzapine was admitted as the cause of ischemia. Clinicians should be aware of how to recognize and treat the potentially life-threatening effects of neuroleptics.

  18. Sammenligning af sertindols og olanzapins effekt på kognition

    Nielsen, René Ernst

    Der er gennem de senere år kommet tiltagende fokus, både nationalt og internationalt, på de kognitive deficits der ses hos patienter med skizofreni. Det er kendt at den farmakologiske behandling har indflydelse på kognition funktion, men det er endnu ikke fyldestgørende klarlagt hvorledes de enke...... enkelte atypiske antipsykotika påvirker kognitiv funktion. Der vil blive beskrevet studiedesign for SEROLA studiet, som sammenligner sertindol og olanzapin med kognition, målt med CANTAB, som primært outcome....

  19. Effect of Environmental Cues on Behavioral Efficacy of Haloperidol, Olanzapine and Clozapine in Rats

    Sun, Tao; Liu, Xinfeng; Li, Ming


    Previous studies have reported that context can powerfully modulate the inhibitory effect of an antipsychotic drug on phencyclidine (PCP)-induced hyperlocomotion (a behavioral test used to evaluate putative antipsychotic drugs). The present study investigated the experimental conditions under which environmental stimuli exert their influence through associative conditioning processes. Experiment 1 examined the extent to which prior antipsychotic treatment in the home cages affected a drug’s ability to inhibit PCP-induced hyperlocomotion in a novel motor activity test apparatus. Five days of repeated haloperidol (0.05 mg/kg, sc) and olanzapine (2.0 mg/kg, sc) treatment in the home cages still potentiated their inhibition of PCP-induced hyperlocomotion (i.e. sensitization) assessed in a new environment, whereas the clozapine (10.0 mg/kg, sc) treatment enhanced the development of clozapine tolerance, indicating a lack of environmental modulation of antipsychotic efficacy. Experiment 2 assessed the impact of different numbers of antipsychotic administrations in either the home environment or test environment (e.g. 4, 2 or 0) on a drug’s ability to inhibit PCP-induced hyperlocomotion. Repeated administration of clozapine (5.0 mg/kg, sc) or olanzapine (1.0 mg/kg, sc) for 4 consecutive days, regardless of where these treatments occurred, caused a similar level of inhibition on PCP-induced hyperlocomotion. However, 4-day haloperidol (0.03 mg/kg, sc) treatment in the test apparatus caused a significant higher inhibition than 4-day home cage treatment. Thus, more exposures to the test environment under the influence of haloperidol (but not clozapine or olanzapine) cause a stronger inhibition than fewer exposures, indicating a strong environmental modulation. Collectively, these findings suggest that prior antipsychotic treatment in one environment could alter later antipsychotic-like response assessed in a different environment under certain test conditions. Therefore

  20. Motivation and Performance of Older Australian Academics: A Pilot Study.

    Little, Len; Peter, Hollis

    A pilot study of the Australian higher education system was conducted to determine the following: (1) whether department heads follow a client-centered, diagnostic/prescriptive model as developed by the Australian Committee of Directors and Principals in Advanced Education (ACDP), and if not, which process is used; (2) which developmental…

  1. Effects of aquajogging in obese adults : A pilot study

    Wouters, E.J.M.; van Nunen, A.M.A.; Geenen, R.; Kolotkin, R.L.; Vingerhoets, A.J.J.M.


    Aim and Method. To examine in obese people the potential effectiveness of a six-week, two times weekly aquajogging program on body composition, fitness, health-related quality of life, and exercise beliefs. Fifteen otherwise healthy obese persons participated in a pilot study. Results. Total fat

  2. Causes of Mortality among American College Students: A Pilot Study

    Turner, James C.; Leno, E. Victor; Keller, Adrienne


    This pilot study from self-selected institutions of higher education provides an estimate of the causes and rates of mortality among college students between the ages of 18 and 24 years old. One hundred fifty-seven 4-year colleges participated in an online survey of student deaths during one academic year. A total of 254 deaths were reported. The…

  3. Assessing the Flipped Classroom in Operations Management: A Pilot Study

    Prashar, Anupama


    The author delved into the results of a flipped classroom pilot conducted for an operations management course module. It assessed students' perception of a flipped learning environment after making them experience it in real time. The classroom environment was construed using a case research approach and students' perceptions were studied using…

  4. Feasibility of the Dutch ICF Activity Inventory: a pilot study

    Bruijning, J.E.; van Nispen, R.M.A.; van Rens, G.H.M.B.


    Background. Demographic ageing will lead to increasing pressure on visual rehabilitation services, which need to be efficiently organised in the near future. The Dutch ICF Activity Inventory (D-AI) was developed to assess the rehabilitation needs of visually impaired persons. This pilot study tests

  5. Outcome evaluation of a pilot study using "nudges"

    Every school day, over 31 million U.S. children eat school lunches. Unfortunately, students often do not choose the healthy options in the school cafeteria. This paper describes outcome results of a pilot study using "nudges" to improve elementary school students' fruits and vegetables selections. A...

  6. Classifying patients' complaints for regulatory purposes : A Pilot Study

    Bouwman, R.J.R.; Bomhoff, Manja; Robben, Paul; Friele, R.D.


    Objectives: It is assumed that classifying and aggregated reporting of patients' complaints by regulators helps to identify problem areas, to respond better to patients and increase public accountability. This pilot study addresses what a classification of complaints in a regulatory setting

  7. Consumer Understanding of Nutrition Marketing Terms: A Pilot Study

    Haroldson, Amber; Yen, Chih-Lun


    The purpose of this pilot study was to examine the validity of a questionnaire developed to assess adult consumer understanding of nutrition marketing terms and the resulting impact on consumer behavior. Participants (n = 40) completed an electronic questionnaire. Efforts to establish validity and reliability suggest that the questionnaire is a…

  8. Effects of aquajogging in obese adults: a pilot study

    PhD Ronette Kolotkin; MSc Annemieke van Nunen; PhD Rinie Geenen; PhD Ad Vingerhoets; MD E.J.M. Wouters


    Aim and method: To examine in obese people the potential effectiveness of a six-week, two times weekly aquajogging program on body composition, fitness, health-related quality of life and exercise beliefs. Fifteen otherwise healthy obese persons participated in a pilot study. Results: Total fat mass

  9. Can Markers Detect Contract Cheating? Results from a Pilot Study

    Dawson, Phillip; Sutherland-Smith, Wendy


    Contract cheating is the purchasing of custom-made university assignments with the intention of submitting them. Websites providing contract cheating services often claim this form of cheating is undetectable, and no published research has examined this claim. This paper documents a pilot study where markers were paid to mark a mixture of real…

  10. Critical Thinking in Nurse Anesthesia Education: A Pilot Study

    Burns, Shari; Mendel, Shaun; Fisher, Rodney; Cooper, Kimball; Fisher, Michael


    Critical thinking is pivotal for student success in health professions education. Knowing the critical thinking ability of the learner helps educators tailor curriculum to enhance critical thinking. A quantitative comparative pilot study assessed critical thinking ability for students at two distinct points in a nurse anesthesia program…

  11. Physical activity in Georgia state parks: A pilot study

    Lincoln R. Larson; Jason W. Whiting; Gary T. Green


    This pilot study assessed the role of Georgia State Parks in the promotion of physical activity among different racial/ethnic and age groups. Data were collected at three state parks in north Georgia during the summer of 2009 using two research methods: behavior observations (N=2281) and intercept surveys (N=473).

  12. Transferring manual ultrasonic inspection procedures - results of a pilot study

    Anderson, M.; Taylor, T.; Kadenko, I.


    Results of a manual ultrasonic pilot study for NDE specialists at RBMK nuclear reactor sites are presented. Probabilities of detection and false calls, using two different grading criteria, are estimated. Analyses of performance parameters lead to conclusions regarding attributes for improved test discrimination capabilities. (orig.)

  13. Metabolic syndrome and drug discontinuation in schizophrenia: a randomized trial comparing aripiprazole olanzapine and haloperidol.

    Parabiaghi, A; Tettamanti, M; D'Avanzo, B; Barbato, A


    To determine whether the prescription of aripiprazole, compared with olanzapine and haloperidol, was associated with a lower frequency of metabolic syndrome (MS) and treatment discontinuation at 1 year. Patients were randomly assigned to be treated open-label and according to usual clinical practice with either aripiprazole, olanzapine, or haloperidol and followed up for 1 year. Three hundred out-patients with persistent schizophrenia were recruited in 35 mental health services. The intention-to-treat (ITT) analysis found no significant differences in the rate of MS between aripiprazole (37%), olanzapine (47%), and haloperidol (42%). Treatment discontinuation for any cause was higher for aripiprazole (52%) than for olanzapine (33%; OR, 0.41; P = 0.004), or haloperidol (37%; OR, 0.51; P = 0.030). No significant difference was found between olanzapine and haloperidol. Time to discontinuation for any cause was longer for olanzapine than for aripiprazole (HR, 0.55; P haloperidol and aripiprazole, or between olanzapine and haloperidol. The prescription of aripiprazole did not significantly reduce the rates of MS, but its treatment retention was worse. Aripiprazole cannot be considered the safest and most effective drug for maintenance treatment of schizophrenia in routine care, although it may have a place in antipsychotic therapy. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  14. Dissolution studies with pilot plant and actual INTEC calcines

    Herbst, R.S.; Garn, T.G.


    The dissolution of Idaho Nuclear Technology and Engineering Center (INTEC) pilot plant calcines was examined to determine solubility of calcine matrix components in acidic media. Two representatives pilot plant calcine types were studied: Zirconia calcine and Zirconia/Sodium calcine. Dissolution of these calcines was evaluated using lower initial concentrations of nitric acid than used in previous tests to decrease the [H+] concentration in the final solutions. Lower [H+] concentrations contribute to more favorable TRUEX/SREX solvent extraction flowsheet performance. Dissolution and analytical results were also obtained for radioactive calcines produced using high sodium feeds blended with non-radioactive Al(NO 3 ) 3 solutions to dilute the sodium concentration and prevent bed agglomeration during the calcination process. Dissolution tests indicated >95 wt.% of the initial calcine mass can be dissolved using the baseline dissolution procedure, with the exception that higher initial nitric acid concentrations are required. The higher initial acid concentration is required for stoichiometric dissolution of the oxides, primarily aluminum oxide. Statistically designed experiments using pilot plant calcine were performed to determine the effect of mixing rate on dissolution efficiency. Mixing rate was determined to provide minimal effects on wt.% dissolution. The acid/calcine ratio and temperature were the predominate variables affecting the wt.% dissolution, a result consistent with previous studies using other similar types of pilot plant calcines

  15. Nursing Student Perceptions of Digital Textbooks: A Pilot Study.

    Mennenga, Heidi A


    Digital textbooks are increasing in popularity, often resulting from the perception that students demand the use of technology in academics. However, few studies have been done on student perceptions of digital textbooks. A pilot study was conducted with students enrolled in a nursing research course; 123 nursing students participated. This study found that students overwhelmingly preferred print textbooks over digital textbooks. More research needs to be done before assuming students would prefer digital textbooks over print.

  16. Introducing technology into medical education: two pilot studies.

    George, Paul; Dumenco, Luba; Dollase, Richard; Taylor, Julie Scott; Wald, Hedy S; Reis, Shmuel P


    Educators are integrating new technology into medical curriculum. The impact of newer technology on educational outcomes remains unclear. We aimed to determine if two pilot interventions, (1) introducing iPads into problem-based learning (PBL) sessions and (2) online tutoring would improve the educational experience of our learners. We voluntarily assigned 26 second-year medical students to iPad-based PBL sessions. Five students were assigned to Skype for exam remediation. We performed a mixed-method evaluation to determine efficacy. Pilot 1: Seventeen students completed a survey following their use of an iPad during the second-year PBL curriculum. Students noted the iPad allows for researching information in real time, annotating lecture notes, and viewing sharper images. Data indicate that iPads have value in medical education and are a positive addition to the curriculum. Pilot 2: Students agreed that online tutoring is at least or more effective than in-person tutoring. In our pilot studies, students experienced that iPads and Skype are beneficial in medical education and can be successfully employed in areas such as PBL and remediation. Educators should continue to further examine innovative opportunities for introducing technology into medical education. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  17. Self moving patients to the operation theatre - a pilot study

    Qvarfordh, Anna Pernilla; Rovsing, Marie Louise; Esbensen, Bente Appel


    The purpose of this pilot study was to investigate patients' satisfaction with walking to the operation theatre instead of being driven in a bed or wheel chair, and to identify the need for information. In total, 75 patients (aged 15-83 years) participated in the study. A questionnaire was develo......The purpose of this pilot study was to investigate patients' satisfaction with walking to the operation theatre instead of being driven in a bed or wheel chair, and to identify the need for information. In total, 75 patients (aged 15-83 years) participated in the study. A questionnaire...... was developed for this study with two focus areas: "Satisfaction with walking instead of being driven" and "Satisfaction with information". In total, 93pct. reported, that it was a good experience to be allowed to walk to the operation theatre, prior to their surgery. About the same proportion found...

  18. Change in level of productivity in the treatment of schizophrenia with olanzapine or other antipsychotics

    Osuntokun Olawale


    Full Text Available Abstract Background When treating schizophrenia, improving patients' productivity level is a major goal considering schizophrenia is a leading cause of functional disability. Productivity level has been identified as the most preferred treatment outcome by patients with schizophrenia. However, little has been done to systematically investigate productivity levels in schizophrenia. We set out to better understand the change in productivity level among chronically ill patients with schizophrenia treated with olanzapine compared with other antipsychotic medications. We also assessed the links between productivity level and other clinical outcomes. Methods This post hoc analysis used data from 6 randomized, double-blind clinical trials of patients with schizophrenia or schizoaffective disorder, with each trial being of approximately 6 months duration. Change in productivity level was compared between olanzapine-treated patients (HGBG, n = 172; HGHJ, n = 277; HGJB, n = 171; HGLB, n = 281; HGGN, n = 159; HGDH, n = 131 and patients treated with other antipsychotic medications (separately vs. haloperidol [HGGN, n = 97; HGDH, n = 132], risperidone [HGBG, n = 167; HGGN, n = 158], quetiapine [HGJB, n = 175], ziprasidone [HGHJ, n = 271] and aripiprazole [HGLB, n = 285]. Productivity was defined as functional activities/work including working for pay, studying, housekeeping and volunteer work. Productivity level in the prior 3 months was assessed on a 5-point scale ranging from no useful functioning to functional activity/work 75% to 100% of the time. Results Chronically ill patients treated with olanzapine (OLZ experienced significantly greater improvement in productivity when compared to patients treated with risperidone (RISP (OLZ = 0.22 ± 1.19, RISP = -0.03 ± 1.17, p = 0.033 or ziprasidone (ZIP (OLZ = 0.50 ± 1.38, ZIP = 0.25 ± 1.27, p = 0.026, but did not significantly differ from the quetiapine, aripiprazole or haloperidol treatment groups. Among

  19. Pilot-model analysis and simulation study of effect of control task desired control response

    Adams, J. J.; Gera, J.; Jaudon, J. B.


    A pilot model analysis was performed that relates pilot control compensation, pilot aircraft system response, and aircraft response characteristics for longitudinal control. The results show that a higher aircraft short period frequency is required to achieve superior pilot aircraft system response in an altitude control task than is required in an attitude control task. These results were confirmed by a simulation study of target tracking. It was concluded that the pilot model analysis provides a theoretical basis for determining the effect of control task on pilot opinions.

  20. Dose-associated changes in safety and efficacy parameters observed in a 24-week maintenance trial of olanzapine long-acting injection in patients with schizophrenia

    Watson Susan B


    Full Text Available Abstract Background In a recently published 24-week maintenance study of olanzapine long-acting injection (LAI in schizophrenia (Kane et al., 2010, apparent dose-associated changes were noted in both efficacy and safety parameters. To help clinicians balance safety and efficacy when choosing a dose of olanzapine LAI, we further studied these changes. Methods Outpatients with schizophrenia who had maintained stability on open-label oral olanzapine for 4 to 8 weeks were randomly assigned to "low" (150 mg/2 weeks; N = 140, "medium" (405 mg/4 weeks; N = 318, or "high" (300 mg/2 weeks; N = 141 dosages of olanzapine LAI for 24 weeks. Potential relationships between dose and several safety or efficacy measures were examined via regression analysis, the Jonckheere-Terpstra test (continuous data, or the Cochran-Armitage test (categorical data. Results Safety parameters statistically significantly related to dose were mean weight change (low: +0.67 [SD = 4.38], medium: +0.89 [SD = 3.87], high: +1.70 [SD = 4.14] kg, p = .024; effect size [ES] = 0.264 high vs. low dose, mean change in prolactin (low: -5.61 [SD = 12.49], medium: -2.76 [SD = 19.02], high: +3.58 [SD = 33.78] μg/L, p = .001; ES = 0.410 high vs. low dose, fasting triglycerides change from normal at baseline to high (low: 3.2%, medium: 6.0%, high: 18.9%, p = .001; NNT = 7 high vs. low dose and fasting high-density lipoprotein cholesterol change from normal at baseline to low (low: 13.8%, medium: 19.6%, high: 30.7%, p = .019; NNT = 6 high vs. low dose. Efficacy measures significantly related to dose included Positive and Negative Syndrome Scale total score mean change (low: +2.66 [SD = 14.95], medium: -0.09 [SD = 13.47], high: -2.19 [SD = 13.11], p Conclusions Analyses of several safety and efficacy parameters revealed significant associations with dose of olanzapine LAI, with the highest dose generally showing greater efficacy as well as greater adverse changes in metabolic safety measures. When

  1. Highly sensitive voltammetric sensor based on immobilization of bisphosphoramidate-derivative and quantum dots onto multi-walled carbon nanotubes modified gold electrode for the electrocatalytic determination of olanzapine

    Mohammadi-Behzad, Leila [Department of Analytical Chemistry, Faculty of Chemistry, Razi University, Kermanshah (Iran, Islamic Republic of); Gholivand, Mohammad Bagher, E-mail: [Department of Analytical Chemistry, Faculty of Chemistry, Razi University, Kermanshah (Iran, Islamic Republic of); Shamsipur, Mojtaba [Department of Analytical Chemistry, Faculty of Chemistry, Razi University, Kermanshah (Iran, Islamic Republic of); Gholivand, Khodayar [Department of Chemistry, Tarbiat Modares University, Tehran (Iran, Islamic Republic of); Barati, Ali [Department of Analytical Chemistry, Faculty of Chemistry, Razi University, Kermanshah (Iran, Islamic Republic of); Gholami, Akram [Department of Chemistry, Tarbiat Modares University, Tehran (Iran, Islamic Republic of)


    In the present paper, a new bisphosphoramidate derivative compound, 1, 4-bis(N-methyl)-benzene-bis(N-phenyl, N-benzoylphosphoramidate) (BMBPBP), was synthesized and used as a mediator for the electrocatalytic oxidation of olanzapine. The electro-oxidation of olanzapine at the surface of the BMBPBP/CdS-quantum dots/multi-walled carbon nanotubes (BMBPBP/CdS-QDs/MWCNTs) modified gold electrode was studied using cyclic voltammetry, chronoamperometry and electrochemical impedance spectroscopy. This sensor showed an excellent electrocatalytic oxidation activity toward olanzapine at less positive potential, pronounced current response, and good sensitivity. The diffusion coefficient and kinetic parameters (such as electron transfer coefficient and the heterogeneous rate constant) were determined for olanzapine oxidation, using the electrochemical approaches. Surface morphology and electrochemical properties of the prepared modified electrode were investigated by scanning electron microscopy (SEM), cyclic voltammetry and electrochemical impedance spectroscopy techniques. The hydrodynamic amperometry at rotating modified electrode at constant potential versus reference electrode was used for detection of olanzapine. Under optimized conditions, the calibration plot was linear in the concentration range of 20 nM to 100 μM and detection limit was found to be 6 nM. The proposed method was successfully applied to the determination of olanzapine in pharmaceuticals and human serum samples. - Highlights: • A highly sensitive sensor for OLZ determination was developed. • The sensor constructed based on immobilization of BMBPBP on CdS-QDs/MWCNTs Au electrode • The morphology of the modified electrode was examined by SEM. • The prepared sensor shows stable electrochemical behavior at a wide pH range. • The proposed sensor is used for trace determination of OLZ in real samples.

  2. A remotely piloted aircraft system in major incident management: concept and pilot, feasibility study.

    Abrahamsen, Håkon B


    Major incidents are complex, dynamic and bewildering task environments characterised by simultaneous, rapidly changing events, uncertainty and ill-structured problems. Efficient management, communication, decision-making and allocation of scarce medical resources at the chaotic scene of a major incident is challenging and often relies on sparse information and data. Communication and information sharing is primarily voice-to-voice through phone or radio on specified radio frequencies. Visual cues are abundant and difficult to communicate between teams and team members that are not co-located. The aim was to assess the concept and feasibility of using a remotely piloted aircraft (RPA) system to support remote sensing in simulated major incident exercises. We carried out an experimental, pilot feasibility study. A custom-made, remotely controlled, multirotor unmanned aerial vehicle with vertical take-off and landing was equipped with digital colour- and thermal imaging cameras, a laser beam, a mechanical gripper arm and an avalanche transceiver. We collected data in five simulated exercises: 1) mass casualty traffic accident, 2) mountain rescue, 3) avalanche with buried victims, 4) fisherman through thin ice and 5) search for casualties in the dark. The unmanned aerial vehicle was remotely controlled, with high precision, in close proximity to air space obstacles at very low levels without compromising work on the ground. Payload capacity and tolerance to wind and turbulence were limited. Aerial video, shot from different altitudes, and remote aerial avalanche beacon search were streamed wirelessly in real time to a monitor at a ground base. Electromagnetic interference disturbed signal reception in the ground monitor. A small remotely piloted aircraft can be used as an effective tool carrier, although limited by its payload capacity, wind speed and flight endurance. Remote sensing using already existing remotely piloted aircraft technology in pre

  3. HERMES probabilistic risk assessment. Pilot study

    Parisot, F.; Munoz, J.


    The study was performed in 1989 of the contribution of probabilistic analysis for the optimal construction of system safety status in aeronautical and European nuclear industries, shows the growing trends towards incorporation of quantitative safety assessment and lead to an agreement to undertake a prototype proof study on Hermes. The main steps of the study and results are presented in the paper

  4. Clinical outcomes with olanzapine long-acting injection: impact of the 3-hour observation period on patient satisfaction and well-being

    Anand E


    Full Text Available Ernie Anand,1 Lovisa Berggren,2 John Landry,3 Ágoston Tóth,4 Holland C Detke5 1Neuroscience Medical Affairs, Eli Lilly & Company Ltd, Windlesham, UK; 2Global Statistical Sciences, Lilly Deutschland GmbH, Bad Homburg, Germany; 3Global Statistical Sciences, Eli Lilly Canada Inc., Toronto, ON, Canada; 4Neuroscience, Lilly Hungary, Budapest, Hungary; 5Psychiatry and Pain Disorders, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA Background: The objective of the present analysis is to determine the impact of the 3-hour observation period for olanzapine long-acting injection (LAI on patient satisfaction and well-being by comparing data collected before and after its implementation. Methods: This is a post hoc analysis of patients treated with olanzapine LAI in 1 a 6-month fixed-dose randomized controlled trial and/or 2 a 6-year open-label safety study. This analysis was limited to patients with schizophrenia who were treated with olanzapine LAI consistent with the approved indication and dosing recommendations of the European Union Summary of Product Characteristics (N=966. Of the 966 patients, the analysis further focused only on those patients who received both 1 at least one injection before the implementation of the 3-hour observation period and 2 at least one injection after implementation of the 3-hour observation period (N=487. Patient satisfaction was assessed with the three-item Patient Satisfaction with Medication Questionnaire-Modified. Responses were averaged across all postbaseline visits occurring before (ie, without the implementation of the 3-hour observation period and across all postbaseline visits occurring after (ie, with the implementation of the 3-hour observation period. In addition, the rate of postinjection delirium/sedation syndrome events was calculated. Results: There was no meaningful change after implementation of the 3-hour observation period in satisfaction (before: mean [SD] =4.0 [1.02] and

  5. Pilot study of erlotinib in patients with acute myeloid leukemia.

    Sayar, Hamid; Czader, Magdalena; Amin, Chirag; Cangany, Mary; Konig, Heiko; Cripe, Larry D


    We conducted a pilot study to investigate clinical efficacy of tyrosine kinase inhibitor erlotinib in the treatment of acute myeloid leukemia (AML). A total of 11 patients with de novo AML were treated, including 2 with relapsed and/or refractory disease and 9 older patients with previously untreated AML. Patients with high baseline leukocyte count were excluded. Erlotinib was given orally at 150 mg per day continuously in 28-day cycles. The treatment was tolerated well, and no toxicities were observed. An initial reduction in circulating blasts, followed by disease progression, was observed in 2 patients. Nine other patients did not demonstrate any response in blood or bone marrow. Baseline and post-cycle 1 flow-cytometry were performed on bone marrow blasts to investigate signs of differentiation. No immunophenotypic changes suggestive of differentiation were observed. This pilot study did not demonstrate response to standard doses of erlotinib in patients with AML. Copyright © 2014 Elsevier Ltd. All rights reserved.

  6. The Flower Workshop in psychosocial rehabilitation: a pilot study.

    Pereira, Alfredo; Pereira, Maria Alice Ornellas


    We report a pilot study with the Flower Workshop, a new modality of psychosocial rehabilitation group activity. Cognitive performance in schizophrenia and other mental conditions can be impaired depending on the tasks to be executed and their respective social context. The vulnerability of these individuals can be reduced by means of cognitive and socio-affective facilitation. We conducted a pilot study to introduce the Flower Workshop in a public Mental Health Service in the city of Ribeirão Preto (São Paulo-Brasil) with 12 participants during 18 months (2002-2003). With cognitive and socio-affective facilitation, participants were able to construct vases and make flower arrangements successfully.

  7. A patient treated with olanzapine developing diabetes de novo : proposal for hyperglycaemia screening

    Duiverman, M. L.; Cohen, D.; van Oven, W.; Nieboer, P.


    We report a patient with schizophrenia who developed diabetes mellitus during treatment with olanzapine. The case confirms the pattern of atypical antipsychotic-related diabetic emergencies: rapid onset in relatively young patients, often with severe glucose derangements and serious complications.

  8. Evaluation of health resources expenditure in two groups of psychotic patients treated with olanzapine and typical neuroleptics in a Italian Mental Health Department in Calabria Region

    Anna Caputo


    Full Text Available Numerous Italian and international trials have studied the global costs of treatment with olanzapine and typical neuroleptics. Our analysis confirms those results. In our study, treatment with olanzapine, as compared to typical neuroleptics, was associated with a greater reduction in emergency interventions (hospitalisations, with an increased use of rehabilitation services and with a small increase in the number of working days. The differences between the two groups for this variable were not great, while the differences in the assessment scores appeared important and statistically significant. The results of present study are relative to the practice of one Italian Mental Health Department and, for this reason, cannot be generalized. Anyway, they are another indication of increased efficiency of atypicals treatment over older neuroleptics in schizophrenia.

  9. Peer Mentoring for Male Parolees: A CBPR Pilot Study.

    Marlow, Elizabeth; Grajeda, William; Lee, Yema; Young, Earthy; Williams, Malcolm; Hill, Karen


    Formerly incarcerated adults are impoverished, have high rates of substance use disorders, and have long histories of imprisonment. This article describes the development of a peer mentoring program for formerly incarcerated adults and the pilot study designed to evaluate it. The research team, which included formerly incarcerated adults and academic researchers, developed the peer mentoring program to support formerly incarcerated adults' transition to the community after prison. The purposes of the pilot evaluation study were to (1) assess the feasibility of implementing a peer-based intervention for recently released men developed using a community-based participatory research (CBPR) approach; (2) establish preliminary data on the program's impact on coping, self-esteem, abstinence self-efficacy, social support, and participation in 12-step meetings; and (3) establish a CBPR team of formerly incarcerated adults and academic researchers to develop, implement, and test interventions for this population. This pilot evaluation study employed a mixed-methods approach with a single group pretest/posttest design with 20 men on parole released from prison within the last 30 days. Quantitative findings showed significant improvement on two abstinence self-efficacy subscales, negative affect and habitual craving. Qualitative findings revealed the relevance and acceptance of peer mentoring for this population. This study demonstrated the feasibility and import of involving formerly incarcerated adults in the design, implementation, and testing of interventions intended to support their reintegration efforts.

  10. Generation Y students’ attitudes towards facebook advertising: pilot study results

    Hilda Bongazana Mahlangu; Ayesha Lian Bevan-Dye


    The purpose of this paper is to report on the results of a pilot study conducted on the determinants and inhibitors of Generation Y students’ attitudes towards Facebook advertising. The findings suggest that Generation Y students have a positive attitude towards the information value, entertainment value, credibility, self-brand congruity of advertising on Facebook and attitude towards the social interaction value of Facebook. Their attitudes towards trust in the site and trust in the members...

  11. LAM Pilot Study with Imatinib Mesylate (LAMP-1)


    AWARD NUMBER: W81XWH-14-1-0132 TITLE: LAM Pilot Study with Imatinib Mesylate (LAMP-1) PRINCIPAL INVESTIGATOR: Charlie Strange, MD...regarding imatinib mesylate (imatinib) in the treatment of Lymphangioleiomyomatosis ( LAM ) sufficient to power and design a phase 3 imatinib vs. placebo...clinical trial. The hypothesis is that imatinib will be equivalent to rapamycin in short term efficacy and safety. Currently, most LAM patients are

  12. Human biomonitoring pilot study DEMOCOPHES in Germany

    Schwedler, Gerda; Seiwert, Margarete; Fiddicke, Ulrike


    , cadmium, cotinine and several phthalate metabolites in urine of 6–11 year old children and their mothers in an urban and a rural region. Seventeen European countries simultaneously conducted this cross-sectional DEMOCOPHES feasibility study. The German study population was taken in the city of Bochum...... and in the Higher Sauerland District, comprising 120 mother-child pairs. In the present paper features of the study implementation are presented. German exposure concentrations of the pollutants are reported and compared with European average concentrations from DEMOCOPHES and with those measured......Human biomonitoring (HBM) is an effective tool to assess human exposure to environmental pollutants, but comparable HBM data in Europe are lacking. In order to expedite harmonization of HBM studies on a European scale, the twin projects COPHES (Consortium to Perform Human Biomonitoring...

  13. Restoring effective sleep tranquility (REST): A feasibility and pilot study.

    Eakman, Aaron M; Schmid, Arlene A; Henry, Kimberly L; Rolle, Natalie R; Schelly, Catherine; Pott, Christine E; Burns, Joshua E


    The purpose of this pilot study was to establish the feasibility of completing a future controlled trial of a multi-component cognitive behavioral therapy for insomnia program for military veterans with sleep disturbance. This was a single-arm feasibility and pilot study. Participants were United States post-9/11 veterans with service-connected injuries, university students, and had self-reported sleep disturbances. Restoring Effective Sleep Tranquility was a multi-component cognitive behavioral therapy for insomnia intervention consisting of seven sessions of group therapy and eight 1:1 sessions delivered by occupational therapists. Feasibility and pilot indicators were process, resources, management, and scientific, including pre-post-assessments of sleep difficulties, dysfunctional sleep beliefs, participation, and pain interference. Indicators were supportive of feasibility, including reduced sleep difficulties (for example Medical Outcomes Study Sleep Measure [ t  = 3.29, p  = .02]), reduced nightmares: t  = 2.79, p  = .03; fewer dysfunctional sleep beliefs: t  = 3.63, p  = .01, and greater ability to participate in social roles: t  = -2.86, p  = .03, along with trends towards improved satisfaction with participation and reduced pain interference. The Restoring Effective Sleep Tranquility program may reduce sleep difficulties and improve participation in US veterans with service-connected injuries, and evidence indicates a controlled trial would be feasible to deliver.

  14. Pregnancy exposure to olanzapine, quetiapine, risperidone, aripiprazole and risk of congenital malformations. A systematic review

    Ennis, Zandra Nymand; Damkier, Per


    /22 (5.1%) and 100/5 (5.0%), respectively. Relative risk estimates and 95% confidence intervals were 1.0 (0.7-1.4) (olanzapine), 1.0 (0.6-1.7) (quetiapine), 1.5 (0.9-2.2) (risperidone) and 1.4 (0.5-3.1) (aripiprazole). First-trimester exposure to olanzapine is not associated with an increased risk...

  15. Olanzapine-induced weight gain: lessons learned from developing rat models

    van der Zwaal, E.M.


    Olanzapine is an effective and commonly prescribed antipsychotic drug, used for the treatment of schizophrenia and bipolar disorder. Unfortunately significant weight gain is a common side effect. In order to effectively address this side effect, it is crucial to gain insight into the underlying mechanisms. Therefore, this thesis describes the development of a number of rat models that were designed to determine the effects of olanzapine on different aspects of energy balance. In both short- a...

  16. Low-Cost Radon Reduction Pilot Study

    Rose, William B. [Partnership for Advanced Residential Retrofit, Champaign, IL (United States); Francisco, Paul W. [Partnership for Advanced Residential Retrofit, Champaign, IL (United States); Merrin, Zachary [Partnership for Advanced Residential Retrofit, Champaign, IL (United States)


    The aim of the research was to conduct a primary scoping study on the impact of air sealing between the foundation and the living space on radon transport reduction across the foundation-living space floor assembly. Fifteen homes in the Champaign, Illinois area participated in the study. These homes were instrumented for hourly continuous radon measurements and simultaneous temperature and humidity the foundation was improved. However, this improved isolation did not lead to significant reductions in radon concentration in the living space. Other factors such as outdoor temperature were shown to have an impact on radon concentration.

  17. Pilot study of a multimodal intervention

    Jarden, Mary Ellen; Hovgaard, Doris; Boesen, Ellen


    Substantial physical and functional deconditioning and diminished psychological wellbeing are all potential adverse effects of allogeneic stem cell transplantation (allo-HSCT). The aim of this study was to evaluate the feasibility, safety and benefits (physical and functional capacity) of a 4-6 w...

  18. Educational Optimism among Parents: A Pilot Study

    Räty, Hannu; Kasanen, Kati


    This study explored parents' (N = 351) educational optimism in terms of their trust in the possibilities of school to develop children's intelligence. It was found that educational optimism could be depicted as a bipolar factor with optimism and pessimism on the opposing ends of the same dimension. Optimistic parents indicated more satisfaction…

  19. Motivation in the Classroom: A Pilot Study.

    Schilling, Deanna E.

    Purposes of this study were to (1) investigate the validity of Maslow's Hierarchy of Needs as it applies to young children; (2) determine developmental shifts in expressed motivational needs; (3) gather information concerning the worries and fears of young children, particularly those of low socioeconomic status; and (4) gather data regarding…

  20. Pilot-scale study of ballasted-flocculation technology

    Liem, L.E.; Brant, W.H.; Gagne, B.; Michaud, J.; Beaudet, J.-F.; Landry, D.; Braden, K.; Campbell, D.


    A ballasted-flocculation pilot-scale study was undertaken to treat a wide-range river water turbidity (17 to 2,608 NTU). The pilot-scale unit was operated at flowrates of 30 to 63 m 3 /h, which corresponded to loading rates of 40 to 84 m/h. Coagulants, polymers, and microsand were added to enhance the floc agglomeration. The weighted flocs settled rapidly resulting in excellent turbidity removals of 94.7 to 99.9%. At the peak turbidity, the unit had a 99.9% removal performance (2.7 from 2,608 NTU) at a loading rate of 40 m/h. In this case, polyaluminum silicosulfate and anionic polymer dosages were 82 and 1 mg/L, respectively. The microsand recycle rate was kept constant at 4.5 m 3 /h, and 1mg microsand was added for each liter of water treated. (author)

  1. An unusual case of hypothermia associated with therapeutic doses of olanzapine: a case report

    Ratnayake Shiroma L


    Full Text Available Abstract Introduction We report a case of a 42-year-old man who had symptomatic hypothermia as a result of taking olanzapine for paranoid schizophrenia. According to published data, only a few cases of hypothermia associated with olanzapine have been reported since its introduction into clinical use. Case presentation A 42-year-old Sri Lankan man with schizophrenia who was being treated with a therapeutic dose of olanzapine presented with reduced level of consciousness. He had a core temperature of 32°C and was bradycardic. At the time of admission, the electrocardiogram showed sinus bradycardia with J waves. He did not have any risk factors for developing hypothermia except the use of olanzapine. There was improvement in his clinical condition with reversal of electrocardiogram changes following gradual rewarming and the omission of olanzapine. Conclusion Hypothermia induced by antipsychotic medications is not uncommon, but olanzapine-induced hypothermia is rare and occurrence has been reported during initiation or increasing the dose. But here the patient developed hypothermia without dose adjustment.

  2. Olanzapine and sibutramine have opposing effects on the motivation for palatable food.

    van der Zwaal, Esther M; Janhunen, Sanna K; Luijendijk, Mieneke C M; Baclesanu, Roxana; Vanderschuren, Louk J M J; Adan, Roger A H; La Fleur, Susanne E


    Both olanzapine and sibutramine target serotonergic and noradrenergic neurotransmission and influence body weight, but in opposite ways. The second-generation antipsychotic olanzapine, an antagonist at serotonergic and noradrenergic receptors, frequently induces weight gain as a side-effect, whereas sibutramine, a noradrenaline/serotonin reuptake inhibitor, is known as a weight-reducing agent. To investigate whether altered motivation for palatable food influences the effect of these drugs on body weight, we determined their effects on responding for sucrose pellets under a progressive ratio schedule of reinforcement in rats. We found that a low dose of olanzapine selectively increased responding to sucrose, without affecting free-feeding intake of sucrose. In contrast, sibutramine dose-dependently reduced responding to sucrose and similarly reduced free-feeding intake. Furthermore, coadministration of a dose of sibutramine that failed to affect responding to sucrose when administered alone prevented the increase in motivation by the effective dose of olanzapine. These data show that increased motivation for palatable food is likely to be a significant contributor to olanzapine-induced weight gain. Moreover, the ability of sibutramine to reduce this motivation for palatable food may play an important role in the efficacy of sibutramine as an add-on treatment to counteract olanzapine-induced weight gain.

  3. Thrombocytopenia associated with olanzapine: A case report and review of literature

    Swapnajeet Sahoo


    Full Text Available There is limited literature on olanzapine-associated thrombocytopenia. In this report, we present a case of a 32-year-old female, suffering from persistent delusional disorder who had thrombocytopenia (46,000/mm3 with the use of olanzapine 25 mg/day, 6 weeks after starting medication. Blood film did not reveal any evidence of any dysplastic cells, disturbance in the count of other cell lines, and autoimmune workup including antinuclear antibodies and anti-neutrophil cytoplasmic antibodies were found to be negative. Given no other etiology, olanzapine was gradually tapered, and platelet counts were monitored. Reduction in the dose of olanzapine led to an improvement in platelet counts which reached the normal range after complete stoppage of olanzapine. In view of continued psychotic symptoms, she was started on clozapine and which was gradually increased to 200 mg/day with biweekly monitoring of total platelet counts before each increment in the dose of clozapine. Thrombocytopenia did not recur with use of clozapine. With clozapine, her psychosis improved by nearly 60%. A review of literature revealed only eight case reports supporting the association of olanzapine and thrombocytopenia.

  4. The promotion of olanzapine in primary care: an examination of internal industry documents.

    Spielmans, Glen I


    Media reports have discussed how olanzapine was marketed off-label for dementia and subsyndromal bipolar disorder. Much of this marketing occurred in primary care settings. However, these reports have provided few details. In legal proceedings, Lilly disclosed internal documents that detail the strategies utilized to market olanzapine. The current paper addresses the marketing of olanzapine in detail based upon a review of these documents. All 358 documents released by Lilly are publicly available online. Documents were utilized for this review if they were relevant to the marketing of olanzapine in primary care settings in the United States. It was found that olanzapine was marketed off-label in primary care settings for relatively mild symptoms that were framed as bipolar disorder and schizophrenia. A key strategy in this campaign was the use of hypothetical patient profiles in detailing visits, most of which clearly failed to meet diagnostic criteria for any recognized mental disorder. Evidence emerged that olanzapine was also marketed off-label as a treatment for dementia.

  5. Low-cost Radon Reduction Pilot Study

    Rose, William B. [Univ. of Illinois, Urbana-Champaign, IL (United States); Francisco, Paul W. [Univ. of Illinois, Urbana-Champaign, IL (United States); Merrin, Zachary [Univ. of Illinois, Urbana-Champaign, IL (United States)


    The U.S. Department of Energy's Building America research team Partnership for Advanced Residential Retrofits conducted a primary scoping study on the impact of air sealing between the foundation and the living space on radon transport reduction across the foundation and living space floor assembly. Fifteen homes in the Champaign, Illinois, area participated in the study. These homes were instrumented for hourly continuous radon measurements and simultaneous temperature and humidity measurements. Blower door and zone pressure diagnostics were conducted at each house. The treatments consisted of using air-sealing foams at the underside of the floor that separated the living space from the foundation and providing duct sealing on the ductwork that is situated in the foundation area. The hypothesis was that air sealing the floor system that separated the foundation from the living space should better isolate the living space from the foundation; this isolation should lead to less radon entering the living space from the foundation. If the hypothesis had been proven, retrofit energy-efficiency programs may have chosen to adopt these isolation methods for enhanced radon protection to the living space.

  6. High-Resolution Scintimammography: A Pilot Study

    Rachel F. Brem; Joelle M. Schoonjans; Douglas A. Kieper; Stan Majewski; Steven Goodman; Cahid Civelek


    This study evaluated a novel high-resolution breast-specific gamma camera (HRBGC) for the detection of suggestive breast lesions. Methods: Fifty patients (with 58 breast lesions) for whom a scintimammogram was clinically indicated were prospectively evaluated with a general-purpose gamma camera and a novel HRBGC prototype. The results of conventional and high-resolution nuclear studies were prospectively classified as negative (normal or benign) or positive (suggestive or malignant) by 2 radiologists who were unaware of the mammographic and histologic results. All of the included lesions were confirmed by pathology. Results: There were 30 benign and 28 malignant lesions. The sensitivity for detection of breast cancer was 64.3% (18/28) with the conventional camera and 78.6% (22/28) with the HRBGC. The specificity with both systems was 93.3% (28/30). For the 18 nonpalpable lesions, sensitivity was 55.5% (10/18) and 72.2% (13/18) with the general-purpose camera and the HRBGC, respectively. For lesions 1 cm, 7 of 15 were detected with the general-purpose camera and 10 of 15 with the HRBGC. Four lesions (median size, 8.5 mm) were detected only with the HRBGC and were missed by the conventional camera. Conclusion: Evaluation of indeterminate breast lesions with an HRBGC results in improved sensitivity for the detection of cancer, with greater improvement shown for nonpalpable and 1-cm lesions.

  7. Treadmill Desks at LANL - Pilot Study

    Fellows, Samara Kia [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)


    It is well established that sedentariness is the largest, preventable contributor to premature death, eclipsing smoking in recent years. One approach to reduce sedentariness is by using a treadmill desk to perform office work while walking at a low speed.We found an increased interest level when the treadmill desks were first introduced to LANL, but after a few months interest appeared to drop. It is possible that treadmill desk use was occurring, but subjects did not record their use. The treadmill desks will not be readily available for purchase by employees due to the study outcome. Additionally, conclusive changes in body measurements could not be performed due to lack of follow up by 58% of the participants.

  8. An In Vitro Analysis of Disintegration Times of Different Formulations of Olanzapine Orodispersible Tablet: A Preliminary Report

    Hobbs, David; Karagianis, Jamie; Treuer, Tamas; Raskin, Joel


    Background Orodispersible tablets (ODTs) are tablet or wafer forms of medication that disintegrate in the mouth, aided only by saliva. ODTs rely on different fast dissolve/disintegration manufacturing technologies. Objectives Disintegration time differences for several olanzapine ODT forms were investigated. Risperdal M-Tab® was included as a non-olanzapine ODT comparator. Research Design and Methods Eleven olanzapine ODT examples and orodispersible risperidone strengths were evaluated in vit...

  9. Medical exposure to children - a pilot study

    Ingilizova, K.; Borisova, R.


    Patient dose assessment during medical exposure in paediatric diagnostic radiology is of highest importance in view of the greater radiation hazard to children compared to adults. It is conditioned by their higher sensitivity to ionizing radiation and their greater life expectancy. The risk of stochastic effects is several times greater for children than for adults. The attributive risk to children exposed to ionizing radiation during the first 10 years is 3 to 5 times greater than the risk to adults exposed between 30 and 40 years of age, and 6 to 7 times greater compared to the risk to adults exposed after their 50 year. The children dose distribution studies are carried out in order to elaborate national diagnostic reference levels. The dose assessment is complicated by the great variation in body size and anatomical features of children belonging to different age groups. There is a series of difficulties in the definition of image quality criteria and guidelines for good practice due to the dynamically changing body proportions and the anatomical features as a result of the active growth process from infancy through early childhood to adolescence. (author)

  10. Frailty Testing Pilot Study: Pros and Pitfalls.

    Adlam, Taylor; Ulrich, Elizabeth; Kent, Missy; Malinzak, Lauren


    Frailty can be defined as an inflammatory state with a loss of physiologic reserve in multiple systems that manifests as a decreased ability to respond to stressors that ultimately leads to an increased risk of adverse outcomes. The aim of this study was to determine the ease of frailty testing in a pre-kidney transplant clinic and the resources required to do so. A secondary goal was to better understand the utility of frailty testing when evaluating potential kidney transplant recipients. Frailty testing was conducted at a pre-kidney transplant clinic in three phases using Fried's frailty phenotype (shrinking, exhaustion, low physical activity, slowness, and grip strength). A total of 132 frailty tests were completed on 128 patients. Frail patients had significantly higher rates of shrinking (26% vs. 8.5%, P testing was most complete when an examiner dedicated to frailty testing performed the testing. Frailty testing is feasible to complete in a pre-transplant clinic with an appropriate investment in personnel and resources.

  11. Social dysfunction in bipolar disorder: pilot study.

    de Almeida Rocca, Cristiana Castanho; de Macedo-Soares, Marcia Britto; Gorenstein, Clarice; Tamada, Renata Sayuri; Issler, Cilly Kluger; Dias, Rodrigo Silva; Schwartzmann, Angela Maria; Lafer, Beny


    The purpose of the present study was to assess the social skills of euthymic patients with bipolar disorder. A group of 25 outpatients with bipolar disorder type I were evaluated in comparison with a group of 31 healthy volunteers who were matched in terms of level of education, age, sex and intelligence. Both groups were assessed using a self-report questionnaire, the Brazilian Inventario de Habilidades Sociais (IHS, Social Skills Inventory). Two Wechsler Adult Intelligence Scale subtests (Picture Arrangement and Comprehension) were also used in order to assess subject ability to analyse social situations and to make judgements, respectively. Patients with bipolar disorder had lower IHS scores for the domains that assessed conversational skills/social self-confidence and social openness to new people/situations. Patients with anxiety disorders had high scores for the domain that assessed self-confidence in the expression of positive emotions. No differences were found between patients and controls in performance on the Wechsler Adult Intelligence Scale Picture Arrangement and Comprehension subtests. Euthymic patients with bipolar disorder present inhibited and overattentive behaviour in relation to other people and their environment. This behaviour might have a negative impact on their level of social functioning and quality of life.

  12. Telemedicine and Plastic Surgery: A Pilot Study

    Denis Souto Valente


    Full Text Available Background. Telemedicine can be defined as the use of electronic media for transmission of information and medical data from one site to another. The objective of this study is to demonstrate an experience of telemedicine in plastic surgery. Methods. 32 plastic surgeons received a link with password for real-time streaming of a surgery. At the end of the procedure, the surgeons attending the procedure by the Internet answered five questions. The results were analyzed with descriptive statistics. Results. 27 plastic surgeons attended the online procedure in real-time. 96.3% considered the access to the website as good or excellent and 3.7% considered it bad. 14.8% reported that the transmission was bad and 85.2% considered the quality of transmission as good or excellent. 96.3% classified the live broadcasting as a good or excellent learning experience and 3.7% considered it a bad experience. 92.6% reported feeling able to perform this surgery after watching the demo and 7.4% did not feel able. 100% of participants said they would like to participate in other surgical demonstrations over the Internet. Conclusion. We conclude that the use of telemedicine can provide more access to education and medical research, for plastic surgeons looking for medical education from distant regions.

  13. Work stress in radiologists. A pilot study.

    Magnavita, N; Fileni, A; Magnavita, G; Mammi, F; Mirk, P; Roccia, K; Bergamaschi, A


    We studied occupational stress and its psychosocial effects in a sample of Italian radiologists and radiotherapists: Radiologists and radiotherapists attending two medical conferences were invited to complete a questionnaire comprising four sections investigating the risk of occupational stress (organisational discomfort, Karasek's Job Content Questionnaire, Siegrist's Effort-Reward Imbalance, Warr's Job Satisfaction) and four sections investigating the health effects of such stress (Goldberg's Anxiety and Depression Scales, General Health Questionnaire, Lifestyles Questionnaire). Radiologists and radiotherapists generally expressed high levels of control, reward and satisfaction. However, 38.5% complained of severe organisational discomfort, 24% reported job strain, 28% reported effort/reward imbalance and 25% were dissatisfied. Female radiologists and radiotherapists showed higher levels of organisational discomfort than their male colleagues. Younger and less experienced radiologists and radiotherapists had higher strain scores than their older and more experienced colleagues. A significant correlation was observed between stress predictors and the effects of stress on health, including depression and anxiety, psychological distress and unhealthy lifestyles. Radiologists and radiotherapists are exposed to major occupational stress factors, and a significant percentage of them suffer from workplace stress. A special effort is required to prevent this condition.

  14. Oral haloperidol or olanzapine intake produces distinct and region-specific increase in cannabinoid receptor levels that is prevented by high fat diet.

    Delis, Foteini; Rosko, Lauren; Shroff, Aditya; Leonard, Kenneth E; Thanos, Panayotis K


    Clinical studies show higher levels of cannabinoid CB1 receptors (CB1R) in the brain of schizophrenic patients while preclinical studies report a significant functional interaction between dopamine D2 receptors and CB1Rs as well as an upregulation of CB1Rs after antipsychotic treatment. These findings prompted us to study the effects of chronic oral intake of a first and a second generation antipsychotic, haloperidol and olanzapine, on the levels and distribution of CB1Rs in the rat brain. Rats consumed either regular chow or high-fat food and drank water, haloperidol drinking solution (1.5mg/kg), or olanzapine drinking solution (10mg/kg) for four weeks. Motor and cognitive functions were tested at the end of treatment week 3 and upon drug discontinuation. Two days after drug discontinuation, rats were euthanized and brains were processed for in vitro receptor autoradiography. In chow-fed animals, haloperidol and olanzapine increased CB1R levels in the basal ganglia and the hippocampus, in a similar, but not identical pattern. In addition, olanzapine had unique effects in CB1R upregulation in higher order cognitive areas, in the secondary somatosensory cortex, in the visual and auditory cortices and the geniculate nuclei, as well as in the hypothalamus. High fat food consumption prevented antipsychotic-induced increase in CB1R levels in all regions examined, with one exception, the globus pallidus, in which they were higher in haloperidol-treated rats. The results point towards the hypothesis that increased CB1R levels could be a confounding effect of antipsychotic medication in schizophrenia that is circumveneted by high fat feeding. Copyright © 2017 Elsevier Inc. All rights reserved.

  15. Pilot study of nitrogen utilisation in maize

    Futo, I.; Palcsu, L.; Vodila, G.


    Complete text of publication follows. In the cooperation between KITE Ltd., Nadudvar, Hungary and the Hertelendi Laboratory of Environmental Studies, the aim was to determine the ideal locations of fertilising, the ideal distance of rows for the ideal production yield. To track the nitrogen utilisation of maize (Zea mays) 15 N enriched NH 4 NO 3 fertiliser was introduced among the usual fertilisers in the maize field of KITE Ltd. Nadudvar, Hungary on 30 th March 2012, before sowing. Four maize samples were taken from different areas of different fertiliser treatment (non-fertilised and non-labelled, fertilised and non-labelled, fertilised and labelled between the rows and fertilised and labelled within the rows) and from different development stages of the plant on 22 nd May, 8 th June, 6 th July and 7 th September being sampling periods 1-4, respectively. The plant samples were subsampled based on organs: root, stem and leaf. Samples were dried to constant mass and pulverised. The 15 N measurements were made by a Thermo Finnigan Delta PLUS XP isotope ratio mass spectrometer coupled with an elemental analyser. In case of non-fertilised and non-labelled plants, all the three organs were getting 15 N depleted with time, most intensively the stem and the less intensively the root (Figure 1). For the leaves and stems of the fertilised and non-labelled plants, the tendency in time is very similar to the ones of the non-fertilised and non-labelled plants, however, the roots of the fertilised and non-labelled plants got significantly enriched in the sample of September. In case of the fertilised and labelled between-the-rows samples, labelling is slightly seen as the delta values are positive. These values are significantly lower than the ones for the fertilised and labelled-within-the-rows plants. It is seen that fertiliser got to the vegetation in the largest extent in this layout. Labelling showed its maximum intensity in the second sampling (8 th June) showing that

  16. Melatonin for Reducing Weight Gain Following Administration of Atypical Antipsychotic Olanzapine for Adolescents with Bipolar Disorder: A Randomized, Double-Blind, Placebo-Controlled Trial.

    Mostafavi, Seyed-Ali; Solhi, Mahmoud; Mohammadi, Mohammad-Reza; Akhondzadeh, Shahin


    We aimed to evaluate melatonin effectiveness in weight gain reduction following olanzapine use for 11-17-year-old bipolar disorder patients. Seventy-seven adolescent outpatients, subsequent to their initial diagnosis of bipolar I disorder by a psychiatrist, entered this study. After assessing inclusion and exclusion criteria, 48 patients consented to participate. Twenty-four patients were allocated to receive olanzapine, lithium carbonate, and melatonin, and 24 patients were allocated to receive olanzapine, lithium carbonate, and placebo by simple randomization. The Young Mania Rating Scale (YMRS) was performed at baseline. Before treatment and after 6 and 12 weeks of treatment, weight, height, and body mass index (BMI) were measured. Analysis of variance (ANOVA) with repeated measure and t-test were used to analyze data. Nineteen patients in each group finished the study and their data were entered for analysis. Mean rise in BMI in the melatonin group compared with placebo (2.45 vs. 3.25 respectively) was marginally significant (t = 1.936; df = 36; p = 0.061). ANOVA with repeated measure also showed a marginally significant difference (F = 3.74; df = 1; p = 0.061) between groups and across time in regard to BMI. Mean body weight rise in the melatonin group compared with the placebo group (5.8 kg vs. 8.2 kg respectively) was marginally significant (t = 1.923; df = 28; p = 0.065). ANOVA with repeated measure also showed a marginally significant difference (F = 3.73; df = 1.1; p = 0.056) between groups and across time for body weight. Coadministration of melatonin with olanzapine and lithium carbonate in adolescents with bipolar disorder could reduce the sharp weight gain side effect of these drugs to near significance.

  17. Preliminary Hydrogeologic Characterization Results from the Wallula Basalt Pilot Study

    B.P. McGrail; E. C. Sullivan; F. A. Spane; D. H. Bacon; G. Hund; P. D. Thorne; C. J. Thompson; S. P. Reidel; F. S. Colwell


    The DOE's Big Sky Regional Carbon Sequestration Partnership has completed drilling the first continental flood basalt sequestration pilot borehole to a total depth (TD) of 4,110 feet on the Boise White Paper Mill property at Wallula, Washington. Site suitability was assessed prior to drilling by the 2007-2008 acquisition, processing and analysis of a four-mile, five-line three component seismic swath, which was processed as a single data-dense line. Analysis of the seismic survey data indicated a composite basalt formation thickness of {approx}8,000 feet and absence of major geologic structures (i.e., faults) along the line imaged by the seismic swath. Drilling of Wallula pilot borehole was initiated on January 13, 2009 and reached TD on April 6, 2009. Based on characterization results obtained during drilling, three basalt breccia zones were identified between the depth interval of 2,716 and 2,910 feet, as being suitable injection reservoir for a subsequent CO2 injection pilot study. The targeted injection reservoir lies stratigraphically below the massive Umtanum Member of the Grande Ronde Basalt, whose flow-interior section possesses regionally recognized low-permeability characteristics. The identified composite injection zone reservoir provides a unique and attractive opportunity to scientifically study the reservoir behavior of three inter-connected reservoir intervals below primary and secondary caprock confining zones. Drill cuttings, wireline geophysical logs, and 31one-inch diameter rotary sidewall cores provided geologic data for characterization of rock properties. XRF analyses of selected rock samples provided geochemical characterizations of the rocks and stratigraphic control for the basalt flows encountered by the Wallula pilot borehole. Based on the geochemical results, the pilot borehole was terminated in the Wapshilla Ridge 1 flow of the Grande Ronde Basalt Formation. Detailed hydrologic test characterizations of 12 basalt interflow

  18. Development and pilot testing of daily Interactive Voice Response (IVR) calls to support antiretroviral adherence in India: A mixed-methods pilot study

    Swendeman, Dallas; Jana, Smarajit; Ray, Protim; Mindry, Deborah; Das, Madhushree; Bhakta, Bhumi


    This two-phase pilot study aimed to design, pilot, and refine an automated Interactive Voice Response (IVR) intervention to support antiretroviral adherence for people living with HIV (PLH), in Kolkata, India. Mixed-methods formative research included a community advisory board (CAB) for IVR message development, one-month pre-post pilot, post-pilot focus groups, and further message development. Two IVR calls are made daily, timed to patients’ dosing schedules, with brief messages (

  19. Increased neutrophil–lymphocyte ratio in delirium: a pilot study

    Egberts A


    Full Text Available Angelique Egberts, Francesco US Mattace-Raso Section of Geriatric Medicine, Department of Internal Medicine, Erasmus University Medical Center, Rotterdam, the Netherlands Aim: Delirium is a common and severe complication among older hospitalized patients. The pathophysiology is poorly understood, but it has been suggested that inflammation and oxidative stress may play a role. The aim of this pilot study was to investigate levels of the neutrophil–lymphocyte ratio (NLR – a marker of systemic inflammation and oxidative stress – in patients with and without delirium. Methods: This pilot study was performed within a retrospective chart review study that included acutely ill patients, 65 years and older, who were admitted to the ward of geriatrics of the Erasmus University Medical Center. All patients in whom the differential white blood cell (WBC counts as well as the C-reactive protein (CRP level were determined within 24 h after admission were included in the present study. Differences in NLR between patients with and without delirium were investigated using univariate analysis of variance, with adjustments for age, sex, comorbidities, CRP level, and total WBC count. Results: Eighty-six patients were included. Thirteen patients were diagnosed with delirium. In adjusted models, higher mean NLR values were found in patients with, than in those without, delirium (9.10 vs 5.18, P=0.003. Conclusion: In this pilot study, we found increased NLR levels in patients with delirium. This finding might suggest that an inadequate response of the immune system and oxidative stress may play a role in the pathogenesis of delirium. Further studies are needed to confirm the association between NLR and delirium. Keywords: delirium, pathology, biomarkers, leukocytes, immune system, brain 

  20. Phencyclidine-induced Loss of Asymmetric Spine Synapses in Rodent Prefrontal Cortex is Reversed by Acute and Chronic Treatment with Olanzapine

    Elsworth, John D; Morrow, Bret A; Hajszan, Tibor; Leranth, Csaba; Roth, Robert H


    Enduring cognitive deficits exist in schizophrenic patients, long-term abusers of phencyclidine (PCP), as well as in animal PCP models of schizophrenia. It has been suggested that cognitive performance and memory processes are coupled with remodeling of pyramidal dendritic spine synapses in prefrontal cortex (PFC), and that reduced spine density and number of spine synapses in the medial PFC of PCP-treated rats may potentially underlie, at least partially, the cognitive dysfunction previously observed in this animal model. The present data show that the decrease in number of asymmetric (excitatory) spine synapses in layer II/III of PFC, previously noted at 1-week post PCP treatment also occurs, to a lesser degree, in layer V. The decrease in the number of spine synapses in layer II/III was sustained and persisted for at least 4 weeks, paralleling the observed cognitive deficits. Both acute and chronic treatment with the atypical antipsychotic drug, olanzapine, starting at 1 week after PCP treatment at doses that restore cognitive function, reversed the asymmetric spine synapse loss in PFC of PCP-treated rats. Olanzapine had no significant effect on spine synapse number in saline-treated controls. These studies demonstrate that the effect of PCP on asymmetric spine synapse number in PFC lasts at least 4 weeks in this model. This spine synapse loss in PFC is reversed by acute treatment with olanzapine, and this reversal is maintained by chronic oral treatment, paralleling the time course of the restoration of the dopamine deficit, and normalization of cognitive function produced by olanzapine. PMID:21677652

  1. Chiropractic manipulation in Adolescent Idiopathic Scoliosis: a pilot study

    Stoline Michael R


    Full Text Available Abstract Background Adolescent idiopathic scoliosis (AIS remains the most common deforming orthopedic condition in children. Increasingly, both adults and children are seeking complementary and alternative therapy, including chiropractic treatment, for a wide variety of health concerns. The scientific evidence supporting the use chiropractic intervention is inadequate. The purpose of this study was to conduct a pilot study and explore issues of safety, patient recruitment and compliance, treatment standardization, sham treatment refinement, inter-professional cooperation, quality assurance, and outcome measure selection. Methods Six patients participated in this 6-month study, 5 of whom were female. One female was braced. The mean age of these patients was 14 years, and the mean Cobb angle was 22.2 degrees. The study design was a randomized controlled clinical trial with two independent and blinded observers. Three patients were treated by standard medical care (observation or brace treatment, two were treated with standard medical care plus chiropractic manipulation, and one was treated with standard medical care plus sham manipulation. The primary outcome measure was Cobb, and the psychosocial measure was Scoliosis Quality of Life Index. Results Orthopedic surgeons and chiropractors were easily recruited and worked cooperatively throughout the trial. Patient recruitment and compliance was good. Chiropractic treatments were safely employed, and research protocols were successful. Conclusion Overall, our pilot study showed the viability for a larger randomized trial. This pilot confirms the strength of existing protocols with amendments for use in a full randomized controlled trial. Trial registration This trial has been assigned an international standard randomized controlled trial number by Current Controlled Trials, Ltd. The number is ISRCTN41221647.

  2. Pilot Study on Harmonisation of Reactor Safety in WENRA Countries


    Most of the objectives, set for the Pilot Study, were met. It can be concluded that the methodology was adequate for its purpose. National requirements on selected safety issues have been systematically compared and the major gaps and differences have been identified. Convenient overviews have been provided of differences and similarities between the countries. Furthermore, the conclusions are based on a safety justification and are detailed enough to provide input to a further more detailed analysis on the national level. It was not possible, however, to provide fully verified conclusions about the implementation of the reference levels in the different countries. This has to do with the following constraints on the study: In line with the Terms of Reference, the comparison of formal requirements did not address the more detailed use of criteria and methods to verify compliance. The same requirement could be enforced differently in different regulatory systems, and hence lead to different implementation. The Pilot Study also assessed the implementation, but it was not possible to do this in sufficient detail to identify such differences. The implementation was assessed on the basis of current knowledge of the respective regulatory body, but it was not possible to provide the panels with evidence of the implementation. For these reasons, conclusions about implemented safety provisions in the different countries should be drawn with precaution. The introduction of the panel assessments greatly improved the quality and consistency of the comparison assessments. Uncertainties in the assessments are mainly connected with lack of time to make a detailed analysis in some cases. The reliability of the assessments seems to be sufficient for the objectives of the Pilot Study. The introduction of the IAEA safety standards in the study proved to be helpful and provided confidence in the scope and strictness of the reference levels. This Pilot Study has contributed to

  3. Adjunctive Use of Olanzapine in the Treatment of Avoidant Restrictive Food Intake Disorder in Children and Adolescents in an Eating Disorders Program.

    Brewerton, Timothy D; D'Agostino, Meredith


    There is little information about the pharmacological treatment of avoidant and restrictive food intake disorder (ARFID), a challenging feeding disorder associated with marked impairment and developmental arrest. This brief clinical report seeks to fill this gap. A retrospective chart review of nine patients with ARFID treated in an eating disorder (ED) program (residential, partial hospital, and intensive outpatient levels of care) with adjunctive olanzapine was undertaken. The mean initial and final olanzapine doses were 0.9 + 0.63 mg/day and 2.8 + 1.47 mg/day, respectively. There was a statistically significant difference in weight gain pre- versus post-olanzapine treatment (3.3 ± 7.3 lbs vs. 13.1 ± 7.9 lbs [2.99 ± 6.62 lb SI vs. 11.88 ± 7.17 lb SI], paired t-test (p ARFID patients. Future randomized, placebo-controlled studies in ARFID are warranted.

  4. Expression changes of serotonin receptor gene subtype 5HT3a in peripheral blood mononuclear cells from schizophrenic patients treated with haloperidol and Olanzapin.

    Shariati, Gholam Reza; Ahangari, Ghasem; Hossein-nezhad, Arash; Asadi, Seyed Mohammad; Pooyafard, Farzaneh; Ahmadkhaniha, Hamid Reza


    Serotonin receptors are involved in pathophysiology of schizophrenia and may mediate other neurotransmitter effects. We investigated serotonin receptors gene expression in peripheral blood mononuclear cells (PBMC) of naïve schizophrenic patients, before and after treatment. Also serotonin receptor gene expression was compared in two treatment groups including Haloperidol and Olanzapine. The PBMC was separated from whole blood by Ficoll-hypaque. The total cellular RNA was extracted and the cDNA was synthesized. This process was followed by real-time PCR using primer pairs specific for 5HT(3a) serotonin receptor mRNA and beta-actin as internal control. The results showed the presence of subtype of serotonin receptor in lymphocytes. Serotonin gene expression showed significant changes in Olanzapine treatment group which correlated with Clinical Global Impression (CGI) score improvement. In conclusion, the present study has shown that human PBMC express serotonin receptors 5HT(3a). Moreover, clinical symptom improvement of Olanzapin may be demonstrated by a change in serotonin receptor gene expression.

  5. Effect of Diet on Gulf War Illness: A Pilot Study


    Award Number: W81XWH-15-1-0636 TITLE: Effect of Diet on Gulf War Illness: A Pilot Study PRINCIPAL INVESTIGATOR: Ashok Tuteja, M.D. M.P.H...CONTRACT NUMBER Effect of Diet on Gulf War Illness 5b. GRANT NUMBER W81XWH-15-1-0636 5c. PROGRAM ELEMENT NUMBER 6 . AUTHOR(S) 5d. PROJECT NUMBER...headache) in Veterans with Gulf War Illness. We will also determine if the change in gut flora is a mechanism for improvement in symptoms of IBS and GW

  6. Hydrologic studies for the Waste Isolation Pilot Plant

    Davies, P.B.


    The objective of this paper is to provide a general overview of hydrologic conditions at the Waste Isolation Pilot Plant (WIPP) by describing several key hydrologic studies that have been carried out as part of the site characterization program over the last 20 years. The paper is composed of three parts: background information about general objectives of the WIPP project; information about the geologic and hydrologic setting of the facility; and information about three aspects of the hydrologic system that are important to understanding the long-term performance of the WIPP facility. For additional detailed information, the reader is referred to the references cited in the text

  7. Teaching Billing and Coding to Medical Students: A Pilot Study

    Jiaxin Tran


    Full Text Available Complex billing practices cost the US healthcare system billions of dollars annually. Coding for outpatient office visits [known as Evaluation & Management (E&M services] is commonly particularly fraught with errors. The best way to insure proper billing and coding by practicing physicians is to teach this as part of the medical school curriculum. Here, in a pilot study, we show that medical students can learn well the basic principles from lectures. This approach is easy to implement into a medical school curriculum.

  8. Effects of Aquajogging in Obese Adults: A Pilot Study

    Wouters, Eveline J. M.; Van Nunen, Annemieke M. A.; Geenen, Rinie; Kolotkin, Ronette L.; Vingerhoets, Ad J. J. M.


    Aim and Method. To examine in obese people the potential effectiveness of a six-week, two times weekly aquajogging program on body composition, fitness, health-related quality of life, and exercise beliefs. Fifteen otherwise healthy obese persons participated in a pilot study. Results. Total fat mass and waist circumference decreased 1.4 kg (P = .03) and 3.1 cm (P = .005), respectively. The distance in the Six-Minute Walk Test increased 41 meters (P = .001). Three scales of the Impact of Weig...

  9. Facial recognition and laser surface scan: a pilot study

    Lynnerup, Niels; Clausen, Maja-Lisa; Kristoffersen, Agnethe May


    Surface scanning of the face of a suspect is presented as a way to better match the facial features with those of a perpetrator from CCTV footage. We performed a simple pilot study where we obtained facial surface scans of volunteers and then in blind trials tried to match these scans with 2D...... photographs of the faces of the volunteers. Fifteen male volunteers were surface scanned using a Polhemus FastSCAN Cobra Handheld Laser Scanner. Three photographs were taken of each volunteer's face in full frontal, profile and from above at an angle of 45 degrees and also 45 degrees laterally. Via special...

  10. Indonesian EFL Students’ Perspective on Writing Process: A Pilot Study

    Imelda Hermilinda Abas


    Full Text Available The study was aimed at understanding the EFL Indonesian students’ perspective on the writing process. The pilot study involved two male Indonesian postgraduate students in Universiti Utara Malaysia. The Indonesian students were selected based on the following criteria: (1 had enough knowledge in English writing, indicated by the completion of Academic Writing and Research Methodology courses taken in UUM; (2 had written an unpublished thesis during their undergraduate studies in Indonesia and they are writing their master or doctoral thesis in English; (3 used English extensively in writing their assignments, and in daily activities. Pseudonyms were used to refer to the participants as Sukarno and Suharto. The data were collected through in-depth interviews with the participants. The interview sessions took approximately 15-20 minutes for each participant and were videotaped and audiotaped. Semi-structured interview with 15 questions and probes were used. The results showed that the two participants had positive feelings and attitudes towards writing in English. Although they had a hard time in English writing during their undergraduate in Indonesia, they become fond of writing in English in their postgraduate time due to the exposure to English extensively. In composing, they used brainstorming, drafting, pausing, revising and editing in a recursive manner. Keywords: in-depth interview, pilot study, writing process, English as a Foreign Language (EFL

  11. What is a pilot or feasibility study? A review of current practice and editorial policy

    Cooper Cindy L


    Full Text Available Abstract Background In 2004, a review of pilot studies published in seven major medical journals during 2000-01 recommended that the statistical analysis of such studies should be either mainly descriptive or focus on sample size estimation, while results from hypothesis testing must be interpreted with caution. We revisited these journals to see whether the subsequent recommendations have changed the practice of reporting pilot studies. We also conducted a survey to identify the methodological components in registered research studies which are described as 'pilot' or 'feasibility' studies. We extended this survey to grant-awarding bodies and editors of medical journals to discover their policies regarding the function and reporting of pilot studies. Methods Papers from 2007-08 in seven medical journals were screened to retrieve published pilot studies. Reports of registered and completed studies on the UK Clinical Research Network (UKCRN Portfolio database were retrieved and scrutinized. Guidance on the conduct and reporting of pilot studies was retrieved from the websites of three grant giving bodies and seven journal editors were canvassed. Results 54 pilot or feasibility studies published in 2007-8 were found, of which 26 (48% were pilot studies of interventions and the remainder feasibility studies. The majority incorporated hypothesis-testing (81%, a control arm (69% and a randomization procedure (62%. Most (81% pointed towards the need for further research. Only 8 out of 90 pilot studies identified by the earlier review led to subsequent main studies. Twelve studies which were interventional pilot/feasibility studies and which included testing of some component of the research process were identified through the UKCRN Portfolio database. There was no clear distinction in use of the terms 'pilot' and 'feasibility'. Five journal editors replied to our entreaty. In general they were loathe to publish studies described as 'pilot'. Conclusion

  12. Endoscopic procedure with a modified Reiki intervention: a pilot study.

    Hulse, Rosalinda S; Stuart-Shor, Eileen M; Russo, Jonathan


    This pilot study examined the use of Reiki prior to colonoscopy to reduce anxiety and minimize intraprocedure medications compared with usual care. A prospective, nonblinded, partially randomized patient preference design was employed using 21 subjects undergoing colonoscopy for the first time. Symptoms of anxiety and pain were assessed using a Likert-type scale. Between-group differences were assessed using chi-square analyses and analysis of variance. There were no differences between the control (n = 10) and experimental (n = 11) groups on age (mean = 58 years, SD = 8.5) and gender (53% women). The experimental group had higher anxiety (4.5 vs. 2.6, p = .03) and pain (0.8 vs. 0.2, p = .42) scores prior to colonoscopy. The Reiki intervention reduced mean heart rate (-9 beats/minute), systolic blood pressure (-10 mmHg), diastolic blood pressure (-4 mmHg), and respirations (-3 breaths/minute). There were no between-group differences on intraprocedure medication use or postprocedure physiologic measures. Although the experimental group patients had more symptoms, they did not require additional pain medication during the procedure, suggesting that (1) anxious people may benefit from an adjunctive therapy; (2) anxiety and pain are decreased by Reiki therapy for patients undergoing colonoscopy, and (3) additional intraprocedure pain medication may not be needed for colonoscopy patients receiving Reiki therapy. This pilot study provided important insights in preparation for a rigorous, randomized, controlled clinical trial.

  13. A study of pilot modeling in multi-controller tasks

    Whitbeck, R. F.; Knight, J. R.


    A modeling approach, which utilizes a matrix of transfer functions to describe the human pilot in multiple input, multiple output control situations, is studied. The approach used was to extend a well established scalar Wiener-Hopf minimization technique to the matrix case and then study, via a series of experiments, the data requirements when only finite record lengths are available. One of these experiments was a two-controller roll tracking experiment designed to force the pilot to use rudder in order to coordinate and reduce the effects of aileron yaw. One model was computed for the case where the signals used to generate the spectral matrix are error and bank angle while another model was computed for the case where error and yaw angle are the inputs. Several anomalies were observed to be present in the experimental data. These are defined by the descriptive terms roll up, break up, and roll down. Due to these algorithm induced anomalies, the frequency band over which reliable estimates of power spectra can be achieved is considerably less than predicted by the sampling theorem.

  14. [Dental caries and early childhood development: a pilot study].

    Núñez, F Loreto; Sanz, B Javier; Mejía, L Gloria


    To investigate the association between dental caries and early childhood development in 3-year-olds from Talca, Chile. A pilot study with a convenience sample of 3-year-olds from Talca (n = 39) who attend public healthcare centers. Child development was measured by the Psychomotor Development Index (PDI), a screening tool used nationally among pre-school children to assess language development, fine motor skills and coordination areas. Dental caries prevalence was evaluated by decayed, missing, filled teeth (DFMT) and decayed, missing, filled tooth surfaces (DFMS) ceo-d and ceo-s indexes. The children were divided into two groups according to the PDIscore: those with a score of 40 or more were considered developmentally normal (n = 32), and those with a score below 40 were considered as having impaired development (n = 7). The severity of caries (DMFT) was negatively correlated with PDI (r = -0.82), and children with the lowest TEPSI score had the highest DFMT values. The average DMFT in children with normal development was 1.31, and 3.57 for those with impaired development. This pilot study indicates that the severity of dental caries is correlated with early childhood development. Copyright © 2015. Publicado por Elsevier España, S.L.U.

  15. Feasibility Pilot Study: Training Soft Skills in Virtual Worlds.

    Abshier, Patricia


    In a world where funding is limited, training for healthcare professionals is turning more and more to distance learning in an effort to maintain a knowledgeable and skilled work force. In 2010, Cicatelli Associates, Inc. began exploring the feasibility of using games and virtual worlds as an alternative means to teach skills-training in a distance-learning environment. The pilot study was conducted with six individuals familiar with general counseling and communication skills used by the healthcare industry to promote behavior change. Participants reported that the venue, although challenging at first, showed great potential for use with healthcare providers, as it allowed for more interaction and activities than traditional Webinars. However, there are significant limitations that must be overcome in order for this healthcare training modality to be utilized on a large scale. These limitations included a lack of microgestures and issues regarding the technology being used. In spite of the limitations, however, the potential use of virtual worlds for the training of healthcare providers exists and should be researched further. This article discusses the need and intended benefits of virtual world training as well as the results and conclusions of the pilot study.

  16. Symptom response and side-effects of olanzapine and risperidone in young adults with recent onset schizophrenia

    van Bruggen, Johanna; Tijssen, Jans; Dingemans, Petrus; Gersons, Berthold; Linszen, Donald


    The symptom response and side-effects of olanzapine and risperidone were compared in patients with recent onset schizophrenia. Actively symptomatic patients n=44) randomly, received olanzapine 15 mg (median dose) or risperidone 4 mg (median dose). Symptom response and side-effects were measured

  17. Parental Grief and Marital Issues Aftermath: A Pilot Study

    Nur Atikah Mohamed Hussin


    Full Text Available The death of a child is difficult to the bereaved parents. Literature had associated the loss with marriage disruption. The issues on that the difficulties to communicate, gender-related coping mechanisms and sexual need were discussed as reasons for bereaved parents to have conflict in their relationship. However there is limited knowledge about this issue. A pilot study has been conducted among six bereaved parents. The bereaved parents were Malaysian Muslim bereaved parents. They were interviewed individually to explore the challenges or conflicts that they had experienced after the death of their child. This study revealed that there were situations which bereaved parents described as having difficulties in their relationship. However, this study also revealed that the mutual understanding and respect to each other are the most of important components for bereaved parents to maintain their relationship post-loss. This study suggested the importance of suggesting couple counselling to bereaved parents after the death of their child.

  18. Team Development Measure in Interprofessional Graduate Education: A Pilot Study.

    Beebe, Lora Humphrey; Roman, Marian; Skolits, Gary; Raynor, Hollie; Thompson, Dixie; Franks, Andrea


    A faculty team developed the 4-week Recovery-Based Interprofessional Distance Education (RIDE) rotation for graduate students in their disciplines. The evaluation team identified the Team Development Measure (TDM) as a potential alternative to reflect team development during the RIDE rotation. The TDM, completed anonymously online, was piloted on the second student cohort (N = 18) to complete the RIDE rotation. The overall pretest mean was 60.73 points (SD = 11.85) of a possible 100 points, indicating that students anticipated their RIDE team would function at a moderately high level during the 4-week rotation. The overall posttest mean, indicating student perceptions of actual team functioning, was 72.71 points (SD = 23.31), an average increase of 11.98 points. Although not statistically significant, Cohen's effect size (d = 0.43) indicates an observed difference of large magnitude. No other published work has used the TDM as a pre-/posttest measure of team development. The authors believe the TDM has several advantages as a measure of student response to interprofessional education offerings, particularly in graduate students with prior experience on health care teams. Further work is needed to validate and extend the findings of this pilot study. [Journal of Psychosocial Nursing and Mental Health Services, 56(4), 18-22.]. Copyright 2018, SLACK Incorporated.

  19. Using singing to nurture children's hearing? A pilot study.

    Welch, Graham F; Saunders, Jo; Edwards, Sian; Palmer, Zoe; Himonides, Evangelos; Knight, Julian; Mahon, Merle; Griffin, Susanna; Vickers, Deborah A


    This article reports a pilot study of the potential benefits of a sustained programme of singing activities on the musical behaviours and hearing acuity of young children with hearing impairment (HI). Twenty-nine children (n=12 HI and n=17 NH) aged between 5 and 7 years from an inner-city primary school in London participated, following appropriate ethical approval. The predominantly classroom-based programme was designed by colleagues from the UCL Institute of Education and UCL Ear Institute in collaboration with a multi-arts charity Creative Futures and delivered by an experienced early years music specialist weekly across two school terms. There was a particular emphasis on building a repertoire of simple songs with actions and allied vocal exploration. Musical learning was also supported by activities that drew on visual imagery for sound and that included simple notation and physical gesture. An overall impact assessment of the pilot programme embraced pre- and post-intervention measures of pitch discrimination, speech perception in noise and singing competency. Subsequent statistical data analyses suggest that the programme had a positive impact on participant children's singing range, particularly (but not only) for HI children with hearing aids, and also in their singing skills. HI children's pitch perception also improved measurably over time. Findings imply that all children, including those with HI, can benefit from regular and sustained access to age-appropriate musical activities.

  20. Flight simulation using a Brain-Computer Interface: A pilot, pilot study.

    Kryger, Michael; Wester, Brock; Pohlmeyer, Eric A; Rich, Matthew; John, Brendan; Beaty, James; McLoughlin, Michael; Boninger, Michael; Tyler-Kabara, Elizabeth C


    As Brain-Computer Interface (BCI) systems advance for uses such as robotic arm control it is postulated that the control paradigms could apply to other scenarios, such as control of video games, wheelchair movement or even flight. The purpose of this pilot study was to determine whether our BCI system, which involves decoding the signals of two 96-microelectrode arrays implanted into the motor cortex of a subject, could also be used to control an aircraft in a flight simulator environment. The study involved six sessions in which various parameters were modified in order to achieve the best flight control, including plane type, view, control paradigm, gains, and limits. Successful flight was determined qualitatively by evaluating the subject's ability to perform requested maneuvers, maintain flight paths, and avoid control losses such as dives, spins and crashes. By the end of the study, it was found that the subject could successfully control an aircraft. The subject could use both the jet and propeller plane with different views, adopting an intuitive control paradigm. From the subject's perspective, this was one of the most exciting and entertaining experiments she had performed in two years of research. In conclusion, this study provides a proof-of-concept that traditional motor cortex signals combined with a decoding paradigm can be used to control systems besides a robotic arm for which the decoder was developed. Aside from possible functional benefits, it also shows the potential for a new recreational activity for individuals with disabilities who are able to master BCI control. Copyright © 2016 Elsevier Inc. All rights reserved.

  1. Using interactive video technology in nursing education: a pilot study.

    Zerr, Daria M; Pulcher, Karen L


    A pilot study was conducted to analyze the benefits of using interactive technology with external assessors and graduating senior nursing students during Senior Nurse Leadership Assessment Day at the University of Central Missouri. The primary aim was to determine whether videoconferencing technology would promote recruitment and retention of professional nurse external assessors without compromising student learning. Among the issues discussed are the advantages and disadvantages of using interactive videoconferencing technology in education and the influence of external assessors in nursing education. The study results indicate that interactive videoconferencing is an effective, accepted format for educational opportunities such as Senior Nurse Leadership Assessment Day, based on the lived experiences of the study participants. In addition, the results demonstrate that interactive videoconferencing does not compromise student learning or assessment by external assessors.

  2. PILOT STUDY: Report on the CCPR Pilot Comparison: Spectral Responsivity 10 nm to 20 nm

    Scholze, Frank; Vest, Robert; Saito, Terubumi


    The CCPR Pilot Comparison on spectral responsivity in the 10 nm to 20 nm spectral range was carried out within the framework of the CIPM Mutual Recognition Arrangement by three laboratories: PTB (Germany), NIST (USA), and NMIJ/AIST (Japan) with PTB acting as the central and reporting laboratory. All participating laboratories used monochromatized synchrotron radiation. PTB and NIST used a cryogenic radiometer as the primary standard detector and NMIJ, an ionization chamber with extrapolation by a wavelength-independent detector. The aim of the pilot comparison was to check the accuracy of the radiometric scale of spectral responsivity in the short wavelength EUV spectral range which has recently gained in technological importance. The wavelengths of measurement were from 11.5 nm to 20 nm in 0.5 nm steps and additionally 12.2 nm. The comparison was carried out through the calibration of a group of transfer standard detectors. Two sets of three diodes of types AXUV and SXUV from International Radiation Detectors, Inc. were used for the comparison. The comparison had the form of a star comparison: Pilot-lab A-pilot-lab B-pilot, PTB acting as the pilot laboratory. All results were communicated directly to the pilot laboratory. The report describes in detail the measurements made at PTB and summarizes the reports submitted by the participants. Measurements carried out by the pilot laboratory before and after the circulation of the detectors proved that the stability of the detectors was sufficient for the comparison. For the type AXUV detectors, however, changes in their responsivity contributed to the uncertainty of the comparison. Measurement results from participants and their associated uncertainties were analyzed in this report according to the Guidelines for CCPR Comparison Report Preparation. The uncertainty contributions were separated, as to whether they are wavelength dependent or not. All bilateral DoE are well within the respective k = 2 expanded uncertainty

  3. Acupressure for smoking cessation – a pilot study

    Moody Russell C


    Full Text Available Abstract Background Tobacco smoking is a serious risk to health: several therapies are available to assist those who wish to stop. Smokers who approach publicly funded stop-smoking clinics in the UK are currently offered nicotine replacement therapy (NRT or bupropion, and group behaviour therapy, for which there is evidence of effectiveness. Acupuncture and acupressure are also used to help smokers, though a systematic review of the evidence of their effectiveness was inconclusive. The aim of this pilot project was to determine the feasibility of a study to test acupressure as an adjunct to one anti-smoking treatment currently offered, and to inform the design of the study. Methods An open randomised controlled pilot study was conducted within the six week group programme offered by the Smoking Advice Service in Plymouth, UK. All participants received the usual treatment with NRT and group behavioural therapy, and were randomised into three groups: group A with two auricular acupressure beads, group B with one bead, and group C with no additional therapy. Participants were taught to press the beads when they experienced cravings. Beads were worn in one ear for four weeks, being replaced as necessary. The main outcome measures assessed in the pilot were success at quitting (expired CO ≤ 9 ppm, the dose of NRT used, and the rating of withdrawal symptoms using the Mood and Symptoms Scale. Results From 49 smokers attending four clinics, 24 volunteered to participate, 19 attended at least once after quitting, and seven remained to the final week. Participants who dropped out reported significantly fewer previous quit attempts, but no other significant differences. Participants reported stimulating the beads as expected during the initial days after quitting, but most soon reduced the frequency of stimulation. The discomfort caused by the beads was minor, and there were no significant side effects. There were technical problems with adhesiveness of

  4. Development of a modified electrode with amine-functionalized TiO{sub 2}/multi-walled carbon nanotubes nanocomposite for electrochemical sensing of the atypical neuroleptic drug olanzapine

    Arvand, Majid, E-mail:; Palizkar, Bahareh


    In this work, using of amine-functionalized TiO{sub 2}/multi-walled carbon nanotubes (NH{sub 2}-TiO{sub 2}-MWCNTs) nanocomposite for modification of glassy carbon electrode (GCE) was investigated. The nanocomposite was characterized by Fourier transformed infrared spectroscopy, transmission electron microscopy and scanning electron microscopy. The efficiency of modified electrode for electrocatalytic the oxidation of olanzapine was studied by cyclic voltammetry, square wave voltammetry and chronoamperometry. The electrochemical measurements were carried out in phosphate-buffered solution (PBS, pH 5.0). The NH{sub 2}-TiO{sub 2}-MWCNTs/GCE provided high surface area and more sensitive performance. The charge transfer coefficient (α) and the apparent charge transfer rate constant (k{sub s}) were calculated to be equal to 0.42 and 0.173 s{sup −1}, respectively. The square wave voltammetry exhibited two linear dynamic ranges and a detection limit of 0.09 μM of olanzapine. In addition, the modified electrode was employed for the determination of olanzapine in pharmaceutical and human blood serum samples in order to illustrate the applicability of proposed method. - Highlights: • A simple and rapid sensor for determination of olanzapine in tablet and serum was prepared. • The amine-functionalized TiO{sub 2}-MWCNTs/GCE showed an obvious increase in surface area. • The presence of NH{sub 2}-TiO{sub 2} nanoparticles showed good ability to distinguish the response of olanzapine.

  5. Cold flow model study of an oxyfuel combustion pilot plant

    Guio-Perez, D.C.; Tondl, G.; Hoeltl, W.; Proell, T.; Hofbauer, H. [Vienna University of Technology, Institute of Chemical Engineering, Vienna (Austria)


    The fluid-dynamic behavior of a circulating fluidized bed pilot plant for oxyfuel combustion was studied in a cold flow model, down-scaled using Glicksman's criteria. Pressures along the unit and the global circulation rate were used for characterization. The analysis of five operating parameters and their influence on the system was carried out; namely, total solids inventory and the air velocity of primary, secondary, loop seal and support fluidizations. The cold flow model study shows that the reactor design allows stable operation at a wide range of fluidization rates, with results that agree well with previous observations described in the literature. (Copyright copyright 2011 WILEY-VCH Verlag GmbH and Co. KGaA, Weinheim)

  6. Physiologic Pressure and Flow Changes During Parabolic Flight (Pilot Study)

    Pantalos, George; Sharp, M. Keith; Mathias, John R.; Hargens, Alan R.; Watenpaugh, Donald E.; Buckey, Jay C.


    The objective of this study was to obtain measurement of cutaneous tissue perfusion central and peripheral venous pressure, and esophageal and abdominal pressure in human test subjects during parabolic flight. Hemodynamic data recorded during SLS-I and SLS-2 missions have resulted in the paradoxical finding of increased cardiac stroke volume in the presence of a decreased central venous pressure (CVP) following entry in weightlessness. The investigators have proposed that in the absence of gravity, acceleration-induced peripheral vascular compression is relieved, increasing peripheral vascular capacity and flow while reducing central and peripheral venous pressure, This pilot study seeks to measure blood pressure and flow in human test subjects during parabolic flight for different postures.

  7. RNA sequencing reveals a slow to fast muscle fiber type transition after olanzapine infusion in rats.

    Christopher J Lynch

    Full Text Available Second generation antipsychotics (SGAs, like olanzapine, exhibit acute metabolic side effects leading to metabolic inflexibility, hyperglycemia, adiposity and diabetes. Understanding how SGAs affect the skeletal muscle transcriptome could elucidate approaches for mitigating these side effects. Male Sprague-Dawley rats were infused intravenously with vehicle or olanzapine for 24h using a dose leading to a mild hyperglycemia. RNA-Seq was performed on gastrocnemius muscle, followed by alignment of the data with the Rat Genome Assembly 5.0. Olanzapine altered expression of 1347 out of 26407 genes. Genes encoding skeletal muscle fiber-type specific sarcomeric, ion channel, glycolytic, O2- and Ca2+-handling, TCA cycle, vascularization and lipid oxidation proteins and pathways, along with NADH shuttles and LDH isoforms were affected. Bioinformatics analyses indicate that olanzapine decreased the expression of slower and more oxidative fiber type genes (e.g., type 1, while up regulating those for the most glycolytic and least metabolically flexible, fast twitch fiber type, IIb. Protein turnover genes, necessary to bring about transition, were also up regulated. Potential upstream regulators were also identified. Olanzapine appears to be rapidly affecting the muscle transcriptome to bring about a change to a fast-glycolytic fiber type. Such fiber types are more susceptible than slow muscle to atrophy, and such transitions are observed in chronic metabolic diseases. Thus these effects could contribute to the altered body composition and metabolic disease olanzapine causes. A potential interventional strategy is implicated because aerobic exercise, in contrast to resistance exercise, can oppose such slow to fast fiber transitions.

  8. Pilot Implementations

    Manikas, Maria Ie

    by conducting a literature review. The concept of pilot implementation, although commonly used in practice, is rather disregarded in research. In the literature, pilot implementations are mainly treated as secondary to the learning outcomes and are presented as merely a means to acquire knowledge about a given...... objective. The prevalent understanding is that pilot implementations are an ISD technique that extends prototyping from the lab and into test during real use. Another perception is that pilot implementations are a project multiple of co-existing enactments of the pilot implementation. From this perspective......This PhD dissertation engages in the study of pilot (system) implementation. In the field of information systems, pilot implementations are commissioned as a way to learn from real use of a pilot system with real data, by real users during an information systems development (ISD) project and before...

  9. Study Skills Analysis: A Pilot Study Linking a Success and Psychology Course

    Urciuoli, Jannette Alejandra; Bluestone, Cheryl


    This study explored a concept that learning study skills in the context of the content area under study may transfer across courses, multiplying the benefits towards academic success. Methods that have been reported to influence academic growth at the community college level include success courses and applied study skills. In this pilot project…

  10. Social media in adolescent health literacy education: a pilot study.

    Tse, Carrie Kw; Bridges, Susan M; Srinivasan, Divya Parthasarathy; Cheng, Brenda Ss


    While health literacy has gained notice on a global stage, the initial focus on seeking associations with medical conditions may have overlooked its impact across generations. Adolescent health literacy, specifically in dentistry, is an underexplored area despite the significance of this formative stage on an individual's approach to healthy lifestyles and behaviors. The aim is to conduct a pilot study to evaluate the efficacy of three major social media outlets - Twitter, Facebook, and YouTube - in supporting adolescents' oral health literacy (OHL) education. A random sample of 22 adolescents (aged 14-16 years) from an English-medium international school in Hong Kong provided informed consent. Sociodemographic information, including English language background, social media usage, and dental experience were collected via a questionnaire. A pre- and post-test of OHL (REALD-30) was administered by two trained, calibrated examiners. Following pre-test, participants were randomly assigned to one of three social media outlets: Twitter, Facebook, or YouTube. Participants received alerts posted daily for 5 consecutive days requiring online accessing of modified and original OHL education materials. One-way ANOVA ( analysis of variance) was used to compare the mean difference between the pre- and the post-test results among the three social media. No associations were found between the social media allocated and participants' sociodemographics, including English language background, social media usage, and dental experience. Of the three social media, significant differences in literacy assessment scores were evident for participants who received oral health education messages via Facebook (P=.02) and YouTube (P=.005). Based on the results of the pilot study, Facebook and YouTube may be more efficient media outlets for OHL promotion and education among adolescent school children when compared to Twitter. Further analyses with a larger study group is warranted.

  11. The influence of aripiprazole and olanzapine on neurotransmitters level in frontal cortex of prenatally stressed rats.

    Ratajczak, P; Kus, K; Gołembiowska, K; Noworyta-Sokołowska, K; Woźniak, A; Zaprutko, T; Nowakowska, E


    The study aims to verify whether alterations in the level of neurotransmitters have occurred in prenatally stressed rats (animal model of schizophrenia), and whether aripiprazole (ARI) and olanzapine (OLA) modify this level. The effects of ARI (1.5mg/kg) and OLA (0.5mg/kg) were studied by means of microdialysis in freely moving rats (observation time 120min). The level of neurotransmitters (DA, 5-HT, NA) and their metabolites (DOPAC, HVA, 5-HIAA) was analyzed by HPLC with coulochemical detection. Obtained results indicate that after a single administration of ARI and OLA in the prenatally stressed rats the increase of DA, DOPAC, and 5-HT was observed. In turn ARI administration increase the level of HVA and 5-HIAA and also decrease the level of NA. After OLA administration the level of NA and HVA increased and no significant change in 5-HIAA was observed. Alterations observed as a result of ARI and OLA administration may be pivotal in identifying animal models of mental disorders and in the analysis of neuroleptics effectiveness. Copyright © 2016 Elsevier B.V. All rights reserved.

  12. Concurrent chemoradiotherapy for advanced cervical cancer. A pilot study

    Kodama, Junichi; Hashimoto, Ichiro; Seki, Noriko; Hongo, Atsushi; Mizutani, Yasushi; Miyagi, Yasunari; Yoshinouchi, Mitsuo; Kudo, Takafumi


    Recently, attempts have made to use radiotherapy in combination with chemotherapy in various solid tumors including cervical cancer. Twenty-four patients with locally advanced cervical cancer were treated with concurrent Carboplatin (16-24 mg/m 2 /day) or Nedaplatin (20 mg/m 2 /week) and conventional radiotherapy. Of 13 evaluable patients, there were nine complete responders and four partial responders. There was no renal damage or grade 4 hematological toxicity. Gastrointestinal adverse reactions were mild. One patient had grade 3 dermatologic toxicity after delayed radiation therapy. This pilot study suggests that daily Carboplatin or weekly Nedaplatin administered with standard radiation therapy is safe, well-tolerated, and thus may be useful as a radiation sensitizer in the treatment of locally advanced cervical cancer. (author)

  13. Entrepreneurial behavior among employees. Pilot study: Employees from Bucharest

    Ionuţ Constantin


    Full Text Available Many objective or subjective factors influence the decision to open a business. The most important factors are: the existence of an adequate opportunity or a market, perception that starting a business could be difficult because of bureaucracy, financial barriers or the need to acquire new skills, a lack of money, etc. Also, entrepreneurial behavior is generally influenced by socio-economic status of the family of origin [1]. Thus, children from wealthy families have the “competitive advantage” to receive an education appropriate for managing a business and of course have the necessary financial resources and its start [2]. However, abilities of every individual can “correct’’ these benefits are completely eliminated/reduced exogenous barriers [3]. In this article I will present the results of a pilot study conducted in 2014 at Bucharest employees to observe their entrepreneurial behavior.

  14. Impact of nutrition messages on children's food choice: pilot study.

    Bannon, Katie; Schwartz, Marlene B


    This pilot study tested the influence of nutrition message framing on snack choice among kindergarteners. Three classrooms were randomly assigned to watch one of the following 60s videos: (a) a gain-framed nutrition message (i.e. the positive benefits of eating apples) (n=14); (b) a loss-framed message (i.e. the negative consequences of not eating apples) (n=18); or (c) a control scene (children playing a game) (n=18). Following this, the children were offered a choice between animal crackers and an apple for their snack. Among the children who saw one of the nutrition message videos, 56% chose apples rather than animal crackers; in the control condition only 33% chose apples. This difference was statistically significant (chi2=7.56, p<0.01). These results suggest that videos containing nutritional messages may have a positive influence on children's short-term food choices.

  15. A Pilot Study on Measuring Customer’s Satisfaction Level

    Vide Boltez


    Full Text Available RQ: Determine the level of customer satisfaction of a company’s products and services to obtain information on needed improvements.Purpose: The purpose of measuring customer’s satisfaction level is to obtain information directly from the final buyer that bought our product. The next step is to analyze the information obtained and to take the results into consideration to improve the working process in production and in other departments of the company.Method: The method used for the pilot study to measure customer satisfaction was a short questionnaire that was given to 10 customers of our product and 10 completed questionnaires were obtained.Results: The results showed the level of satisfaction of final buyers of roof tiles and roofs that the company has achieved through their products and services. The results facilitate the production, logistics, purchasing and sales department to obtain information on positive satisfaction levels and areas that need change. At the same time, the final buyer was identified (i.e., name, surname, address, and so forth, which up until now had not been.Organization: The organization will save time and money in the future, because it will continuously measure customer satisfaction to improve production and other departments in the organization towards creating satisfied customers.Society: Final buyers of roofs are, and will be, more satisfied with their decisions, because the organization carries out after-sales satisfaction levels.Originality: The research was original, because up to this date the organization has not conducted research in such a manner.Limitations: The pilot study used 10 completed questionnaires that represent a very small sample to make any generalizations.

  16. The Nonuse, Misuse, and Proper Use of Pilot Studies in Experimental Evaluation Research

    Westlund, Erik; Stuart, Elizabeth A.


    This article discusses the nonuse, misuse, and proper use of pilot studies in experimental evaluation research. The authors first show that there is little theoretical, practical, or empirical guidance available to researchers who seek to incorporate pilot studies into experimental evaluation research designs. The authors then discuss how pilot…

  17. 2000 Annual report NATO/CCMS Pilot Study, Clean Products and Processes (Phase I)

    Wenzel, Henrik; Molin, Christine; Hauschild, Michael Zwicky


    The NATO/Committee on the Challenges of Modern Society third Pilot Study meeting on Clean Products and Processes was held in Copenhagen, Denmark on May 7-12, 2000. This meeting maintained the momentum generated during the of the first two years of the pilot study, focusing on progress made on sev...... homepage....

  18. A pilot study of a Medication Rationalization (MERA) intervention.

    Whitty, Rachel; Porter, Sandra; Battu, Kiran; Bhatt, Pranjal; Koo, Ellen; Kalocsai, Csilla; Wu, Peter; Delicaet, Kendra; Bogoch, Isaac I; Wu, Robert; Downar, James


    Many seriously ill and frail inpatients receive potentially inappropriate or harmful medications and do not receive medications for symptoms of advanced illness. We developed and piloted an interprofessional Medication Rationalization (MERA) approach to deprescribing inappropriate medications and prescribing appropriate comfort medications. We conducted a single-centre pilot study of inpatients at risk of 6-month mortality from advanced age or morbidity. The MERA team reviewed the patients' medications and made recommendations on the basis of guidelines. We measured end points for feasibility, acceptability, efficiency and effectiveness. We enrolled 61 of 115 (53%) eligible patients with a mean age of 79.6 years (standard deviation [SD] 11.7 yr). Patients were taking an average of 11.5 (SD 5.2) medications before admission and had an average of 2.1 symptoms with greater than 6/10 severity on the revised Edmonton Symptom Assessment System. The MERA team recommended 263 medication changes, of which 223 (85%) were accepted by both the medical team and the patient. MERA team's recommendations resulted in the discontinuation of 162 medications (mean 3.1 per patient), dose changes for 48 medications (mean 0.9 per patient) and the addition of 13 medications (mean 0.2 per patient). Patients who received the MERA intervention stopped significantly more inappropriate medications than similar non-MERA comparison patients for whom data were collected retrospectively (3.1 v. 0.9 medications per patient, p < 0.01). The MERA approach was highly acceptable to patients and medical team members. The MERA intervention is feasible, acceptable, efficient and possibly effective for changing medication use among seriously ill and frail elderly inpatients. Scalability and effectiveness may be improved through automation and integration with medication reconciliation programs. Copyright 2018, Joule Inc. or its licensors.

  19. Impact of race on efficacy and safety during treatment with olanzapine in schizophrenia, schizophreniform or schizoaffective disorder

    Hoffmann Vicki


    Full Text Available Abstract Background To examine potential differences in efficacy and safety of treatment with olanzapine in patients with schizophrenia of white and black descent. Methods A post-hoc, pooled analysis of 6 randomized, double-blind trials in the treatment of schizophrenia, schizophreniform disorder, or schizoaffective disorder compared white (N = 605 and black (N = 375 patients treated with olanzapine (5 to 20 mg/day for 24 to 28 weeks. Efficacy measurements included the Positive and Negative Syndrome Scale (PANSS total score; and positive, negative, and general psychopathology scores; and the Clinical Global Impression of Severity (CGI-S scores at 6 months. Safety measures included differences in the frequencies of adverse events along with measures of extrapyramidal symptoms, weight, glucose, and lipid changes over time. Results 51% of black patients and 45% of white patients experienced early study discontinuation (P = .133. Of those who discontinued, significantly more white patients experienced psychiatric worsening (P = .002 while significantly more black patients discontinued for reasons other than efficacy or tolerability (P = .014. Discontinuation for intolerability was not different between groups (P = .320. For the estimated change in PANSS total score over 6 months, there was no significant difference in efficacy between white and black patients (P = .928, nor on the estimated PANSS positive (P = .435, negative (P = .756 or general psychopathology (P = .165 scores. Overall, there was no significant difference in the change in CGI-S score between groups from baseline to endpoint (P = .979. Weight change was not significantly different in white and black patients over 6 months (P = .127. However, mean weight change was significantly greater in black versus white patients at Weeks 12 and 20 only (P = .028 and P = .026, respectively. Additionally, a significantly greater percentage of black patients experienced clinically significant

  20. Examination of staphylococcal stethoscope contamination in the emergency department (pilot) study (EXSSCITED pilot study).

    Tang, Patrick H P; Worster, Andrew; Srigley, Jocelyn A; Main, Cheryl L


    The objective of this study was to determine the prevalence of Staphylococcus-contaminated stethoscopes belonging to emergency department (ED) staff and to identify the proportion of these that were Staphylococcus aureus or methicillin-resistant Staphylococcus aureus (MRSA). We conducted a prospective observational cohort study of bacterial cultures from 100 ED staff members' stethoscopes at three EDs. Study participants were asked to complete a questionnaire. Fifty-four specimens grew coagulase-negative staphylococci and one grew methicillin-susceptible S. aureus. No MRSA was cultured. Only 8% of participants, all of whom were nurses, reported cleaning their stethoscope before or after each patient assessment. Alcohol-based wipes were most commonly used to clean stethoscopes. A lack of time, being too busy, and forgetfulness were the most frequently reported reasons for not cleaning the stethoscope in the ED. This study indicates that although stethoscope contamination rates in these EDs are high, the prevalence of S. aureus or MRSA on stethoscopes is low.

  1. Anthropometric parameters as indicators of metabolic derangements in schizophrenia patients stabilized on olanzapine in an Indian rural population

    Jayanta Kumar Rout


    Full Text Available Context: For any given body mass, Asian Indians have higher central obesity than Europeans. A periodic measurement of body mass index (BMI and waist hip ratio (WHR is practically more feasible than other parameters of metabolic syndrome by repeated blood collection. However, few studies are available on the relative importance of BMI and WHR as markers of dyslipidemia and insulin resistance in schizophrenia patients stabilized on second generation antipsychotics in Indian population. Aim: We conducted the present study on such patients to examine whether BMI or WHR can better predict dyslipidemia and insulin resistance in these patients in a rural area. Settings and Design: The study was a hospital based case control study under rural settings on 38 schizophrenia patients stabilized on olanzapine and 30 matched controls. Materials and Methods: Fasting concentrations of blood glucose, lipid parameters and serum insulin were assessed. Data for Homeostatic model for assessment of insulin resistance (HOMA-IR, BMI, and WHR were obtained to assess the insulin resistance, overall body fat distribution and abdominal fat dispensation respectively. Statistical analysis used: ′t′ test was performed to assay any difference in corresponding mean values between cases and controls. Dependence of HOMA-IR on key parameters was assessed by analysis of co-variance (ANCOVA study. Results: Cases exhibited significantly higher values for HOMA-IR, serum triglyceride and low density lipoprotein cholesterol (LDLc with a significantly lower high density lipoprotein cholesterol (HDLc level. ANCOVA study reflected that irrespective of age and sex, HOMA-IR was dependent on serum triglyceride level and WHR (F=8.3 and 5.7 respectively, P<0.05, but not on BMI (F<0.001, P=0.997. Conclusions: Central obesity could be more closely associated with the pathogenesis of prediabetic state in our case group. So, WHR is a better anthropometric parameter than BMI for an early

  2. A pilot study of MD (psychiatry) theses-based research.

    Srivastava, Shrikant; Agarwal, Vivek; Subramanyam, Alka; Srivastava, Mona; Sathyanarayana Rao, T S; Rao, G Prasad; Khurana, Hitesh; Singh, Archana


    Undertaking a research project is mandatory for MD Psychiatry trainees. The present study was undertaken to assess the type of research activity being undertaken as part of MD Psychiatry dissertation, and its contribution to national and international literature. Three medical colleges supplied the data about the topic, names of the supervisor and the candidate, collaboration, funding accrued, and publication details of MD-based research carried out between years 2000 and 2010 inclusive; 95 records were collected for the final analysis. The details of the publications provided were cross-checked on the internet, which would have taken care of missed publications as well. Most studies were single-point assessment clinical studies. Only 2 studies had been funded, 11 had collaboration with other departments within the same institute, and 5 had inter-institute collaborations. Majority of the studies were not published. Only 30 were published as full paper and 9 as abstracts. Of these 30 full publications, only 3 were published in journals having JCI impact factor values (1.4, 1.3, and 1.4, respectively). The main finding of this pilot study was that MD-based research has low contribution to the national and international literature, and those articles which are published are in low impact journals. Suggestions for modifying this state of affairs are discussed.

  3. HERMES docking/berthing system pilot study. Quantitative assessment

    Munoz Blasco, J.; Goicoechea Sanchez, F.J.


    This study falls within the framework of the incorporation of quantitative risk assessment to the activities planned for the ESA-HERMES project (ESA/ CNES). The main objective behind the study was the analysis and evaluation of the potential contribution of so-called probabilistic or quantitative safety analysis to the optimization of the safety development process for the systems carrying out the safety functions required by the new and complex HERMES Space Vehicle. For this purpose, a pilot study was considered a good start in quantitative safety assessments (QSA), as this approach has been frequently used in the past to establish a solid base in large-scale QSA application programs while avoiding considerable economic risks. It was finally decided to select the HERMES docking/berthing system with Man Tender Free Flyer as the case-study. This report describes the different steps followed in the study, along with the main insights obtained and the general conclusions drawn from the study results. (author)

  4. Including health economic analysis in pilot studies: lessons learned from a cost-utility analysis within the PROSPECTIV pilot study

    Richéal M. Burns


    Full Text Available PurposeTo assess feasibility and health economic benefits and costs as part of a pilot study for a nurse-led, psychoeducational intervention (NPLI for prostate cancer in order to understand the potential for cost effectiveness as well as contribute to the design of a larger scale trial.MethodsMen with stable prostate cancer post-treatment were recruited from two cancer centres in the UK. Eighty-three men were randomised to the NLPI plus usual care or usual care alone (UCA (42 NLPI and 41 UCA; the NLPI plus usual care was delivered in the primary-care setting (the intervention and included an initial face-to-face consultation with a trained nurse, with follow-up tailored to individual needs. The study afforded the opportunity to undertake a short-term within pilot analysis. The primary outcome measure for the economic evaluation was quality of life, as measured by the EuroQol five dimensions questionnaire (EQ-5D (EQ-5D-5L instrument. Costs (£2014 assessed included health-service resource use, out-of-pocket expenses and losses from inability to undertake usual activities.ResultsTotal and incremental costs varied across the different scenarios assessed, with mean cost differences ranging from £173 to £346; incremental effect, as measured by the change in utility scores over the duration of follow-up, exhibited wide confidence intervals highlighting inconclusive effectiveness (95% CI: -0.0226; 0.0438. The cost per patient of delivery of the intervention would be reduced if rolled out to a larger patient cohort.ConclusionsThe NLPI is potentially cost saving depending on the scale of delivery; however, the results presented are not considered generalisable.

  5. Mental disorder in children with physical conditions: a pilot study.

    Butler, Alexandra; Van Lieshout, Ryan J; Lipman, Ellen Louise; MacMillan, Harriet L; Gonzalez, Andrea; Gorter, Jan Willem; Georgiades, Kathy; Speechley, Kathy N; Boyle, Michael H; Ferro, Mark A


    Methodologically, to assess the feasibility of participant recruitment and retention, as well as missing data in studying mental disorder among children newly diagnosed with chronic physical conditions (ie, multimorbidity). Substantively, to examine the prevalence of multimorbidity, identify sociodemographic correlates and model the influence of multimorbidity on changes in child quality of life and parental psychosocial outcomes over a 6-month follow-up. Prospective pilot study. Two children's tertiary-care hospitals. Children aged 6-16 years diagnosed in the past 6 months with one of the following: asthma, diabetes, epilepsy, food allergy or juvenile arthritis, and their parents. Response, participation and retention rates. Child mental disorder using the Mini International Neuropsychiatric Interview at baseline and 6 months. Child quality of life, parental symptoms of stress, anxiety and depression, and family functioning. All outcomes were parent reported. Response, participation and retention rates were 90%, 83% and 88%, respectively. Of the 50 children enrolled in the study, the prevalence of multimorbidity was 58% at baseline and 42% at 6 months. No sociodemographic characteristics were associated with multimorbidity. Multimorbidity at baseline was associated with declines over 6 months in the following quality of life domains: physical well-being, β=-4.82 (-8.47, -1.17); psychological well-being, β=-4.10 (-7.62, -0.58) and school environment, β=-4.17 (-8.18, -0.16). There was no association with parental psychosocial outcomes over time. Preliminary evidence suggests that mental disorder in children with a physical condition is very common and has a negative impact on quality of life over time. Based on the strong response rate and minimal attrition, our approach to study child multimorbidity appears feasible and suggests that multimorbidity is an important concern for families. Methodological and substantive findings from this pilot study have

  6. A pilot study of workplace violence towards paramedics.

    Boyle, Malcolm; Koritsas, Stella; Coles, Jan; Stanley, Janet


    International studies have shown that some 60% of paramedics have experienced physical violence in the workplace, and between 21-78% have experienced verbal abuse. To date, there is no Australian literature describing Australian paramedics' experience of workplace violence. To identify the percentage of paramedics who had experienced six different forms of workplace violence. A questionnaire was developed to explore paramedics' experience of workplace violence. Six forms of violence were included: verbal abuse, property damage or theft, intimidation, physical abuse, sexual harassment, and sexual assault. The questionnaire also included a series of demographic questions. The questionnaire was piloted using a reference group and changes made accordingly. The questionnaire was distributed to 500 rural Victorian paramedics and 430 metropolitan South Australian paramedics. Ethics approval was granted for this study. The overall response rate was 28%, with 75% being male and 25% female. The median age of respondents was 40.7 years, range 21-62 years. The median number of years experience as a paramedic was 14.3 years, range 6 months to 39 years. There were 87.5% of paramedics exposed to workplace violence. Verbal abuse was the most prevalent form of workplace violence (82%), with intimidation (55%), physical abuse (38%), sexual harassment (17%), and sexual assault (4%). This study lays the foundation for further studies investigating paramedic experience of workplace violence. This study demonstrates that workplace violence is prevalent for paramedics and highlights the need for prevention and education within the profession.

  7. MRI study of the morphometry of the cervical musculature in F-16 pilots

    de Loose, Veerle; van den Oord, Marieke; Keser, Ilke; Burnotte, Frédéric; van Tiggelen, Damien; Dumarey, Alexandre; Cagnie, Barbara; Witvrouw, Erik; Danneels, Lieven


    INTRODUCTION: In fighter pilots neck muscle strengthening exercises are often recommended to protect the neck against pathologies. The aim of the current study was to compare the relative cross-sectional area (rCSA) and muscle:fat ratio of the cervical musculature of F-16 pilots experiencing neck

  8. Biomagnetic Pair Therapy and Typhoid Fever: A Pilot Study.

    Frank, Bryan L


    Objective: This pilot study examined the laboratory responses of patients with laboratory-documented typhoid fever who were treated with Biomagnetic Pair Therapy (BPT; medical biomagnetism), a specific application of pairs of magnets for various ailments that are infectious and otherwise. Materials and Methods: This study was an assessment of patients' response to treatment with only BPT for Salmonella typhi infections (typhoid fever) using standard conventional laboratory techniques. The research was conducted in an outpatient village clinic in Kenya. There were 52 participants who were evaluated for possible systemic illness, including typhoid fever, from an open-label study. Participants who felt sick and requested testing for possible typhoid fever were tested with a standard Widal test by a certified laboratory technician. Participants who tested positive (13 patients) were then treated with BPT (a "First Aid" approach) only. These participants then returned for follow-up laboratory and clinical evaluations after 2 days. Results: Most of the participants (10 of 13) retested as negative, and all patients reported symptomatic clinical improvement. Conclusions: As a significant majority of participants demonstrated clearing of their S. typhi after BPT, this technique should be studied further in larger trials for its efficacy in treating typhoid fever.

  9. Fibromyalgia with Gabapentin and Osteopathic Manipulative Medicine: A Pilot Study.

    Marske, Cynthia; Bernard, Natasha; Palacios, Alison; Wheeler, Cary; Preiss, Ben; Brown, Mackenzie; Bhattacharya, Saveri; Klapstein, Gloria


    This pilot study compares the safety and efficacy of three treatments in reducing pain and improving fibromyalgia symptoms. This study was an 8-week prospective, single center feasibility study. Forty subjects were recruited from Solano, Sonoma, and Contra Costa counties of California in 2006-2009. Subjects were aged 18-65 and met the American College of Rheumatology (ACR) 1990 criteria for fibromyalgia. This study had three treatment arms: gabapentin only (900 mg/day), osteopathic manipulative medicine (OMM) only, and combined treatment of gabapentin plus OMM. OMM treatment was administered by advanced medical students for 30 min, once a week. The trial lasted for 8 weeks, which included 6 weeks of treatment plus initial and final visits. Key outcome measures included Wong-Baker FACES Pain Rating Scale (WBF), Clinical Global Impression of Health (CGI), Fibromyalgia Impact Questionnaire (FIQ), and number of tender points. Twenty-nine subjects completed the trial; 8 subjects received gabapentin only, 11 patients received OMM only, and 10 patients received gabapentin plus OMM. Subjects receiving OMM alone and subjects receiving the combined treatment of OMM and gabapentin displayed clinical improvements based on WBF (p treatment and gabapentin are safe and clinically efficacious treatment of pain and other constitutional and somatic symptoms associated with fibromyalgia. A larger trial using the new ACR 2010 Fibromyalgia criteria is needed to confirm these findings.

  10. EEG activity in Muslim prayer: A pilot study

    Haider H. Alwasiti


    Full Text Available Almost all religions incorporate some form of meditation. Muslim prayer is the meditation of Islam. It is an obligatory prayer for all Muslims that is performed five times a day. Although a large body of literature exists on EEG changes in meditation, to date there has been no research published in a peer-reviewed journal on EEG changes during Muslim prayer. The purpose of this pilot study is to encourage further investigation on this type of meditation. Results of EEG analysis in twenty-five trials of Muslim prayer are reported. Some of the findings are consistent with the majority of the previous meditation studies (alpha rhythm slowing, increased alpha rhythm coherence. However, Muslim prayer does not show an increase in alpha and/or theta power like most of the results of other meditation studies. The possible cause of this discrepancy in meditation-related studies is highlighted and a systematic and standardised roadmap for future Muslim prayer EEG research is proposed.

  11. Radon in drinking water in Co. Wicklow. A pilot study

    Ryan, T.P.; Sequeira, S.; McKittrick, L.; Colgan, P.A.


    Attention has been focused on the issue of radon in drinking water by a European Commission recommendation proposing that surveys should be undertaken in Member States to determine the scale and nature of exposures caused by radon in domestic drinking water supplies. The Commission recommends 1000 Bq/l as the radon activity concentration in private drinking water supplies above which remedial action to reduce the concentration should be taken. The logic behind the proposed action level is that it would broadly correspond to the risk posed to an individual from exposure to radon in the home at the current Reference Level of 200 Bq/m3 in air. A pilot study to assess the distribution and concentrations of radon in private ground water supplies was recently completed in Co. Wicklow. County Wicklow was selected for the study primarily on the basis that the underlying geology is predominantly granite with elevated uranium content. Furthermore, there is an estimated 1200 to 5000 private ground water supplies in use in the county and high radon activity concentrations in air in a significant number of dwellings have previously been predicted. As part of the pilot study, a number of scientific issues were addressed in order to underpin the results obtained and these are also discussed in the report. Radon activity concentrations were measured in the private ground water supplies of 166 houses in Co. Wicklow. In all cases the ground water was the principal source of drinking water for the house occupants. Four supplies had activity concentrations in excess of the Recommended EC action level of 1000 Bq/l, fifteen had activity concentrations between 500 and 1000 Bq/l, 51 were between 100 and 500 Bq/l and 96 had activity concentrations below 100 Bq/l. The doses estimated for the ingestion of radon bearing water vary significantly with the quantity of drinking water consumed and the degree to which the water has been processed prior to consumption. However dose estimates based

  12. Radon in drinking water in Co. Wicklow. A pilot study

    Ryan, T.P.; Sequeira, S.; McKittrick, L.; Colgan, P.A.


    Attention has been focused on the issue of radon in drinking water by a European Commission recommendation proposing that surveys should be undertaken in Member States to determine the scale and nature of exposures caused by radon in domestic drinking water supplies. The Commission recommends 1000 Bq/l as the radon activity concentration in private drinking water supplies above which remedial action to reduce the concentration should be taken. The logic behind the proposed action level is that it would broadly correspond to the risk posed to an individual from exposure to radon in the home at the current Reference Level of 200 Bq/m 3 in air. A pilot study to assess the distribution and concentrations of radon in private ground water supplies was recently completed in Co. Wicklow. County Wicklow was selected for the study primarily on the basis that the underlying geology is predominantly granite with elevated uranium content. Furthermore, there is an estimated 1200 to 5000 private ground water supplies in use in the county and high radon activity concentrations in air in a significant number of dwellings have previously been predicted. As part of the pilot study, a number of scientific issues were addressed in order to underpin the results obtained and these are also discussed in the report. Radon activity concentrations were measured in the private ground water supplies of 166 houses in Co. Wicklow. In all cases the ground water was the principal source of drinking water for the house occupants. Four supplies had activity concentrations in excess of the Recommended EC action level of 1000 Bq/l, fifteen had activity concentrations between 500 and 1000 Bq/l, 51 were between 100 and 500 Bq/l and 96 had activity concentrations below 100 Bq/l. The doses estimated for the ingestion of radon bearing water varies significantly with the quantity of drinking water consumed and the degree to which the water has been processed prior to consumption. However dose estimates

  13. Olanzapine-induced weight gain: lessons learned from developing rat models

    van der Zwaal, E.M.


    Olanzapine is an effective and commonly prescribed antipsychotic drug, used for the treatment of schizophrenia and bipolar disorder. Unfortunately significant weight gain is a common side effect. In order to effectively address this side effect, it is crucial to gain insight into the underlying

  14. Dopamine D2 receptor occupancy by olanzapine or risperidone in young patients with schizophrenia

    Lavalaye, J.; Linszen, D. H.; Booij, J.; Reneman, L.; Gersons, B. P.; van Royen, E. A.


    A crucial characteristic of antipsychotic medication is the occupancy of the dopamine (DA) D2 receptor. We assessed striatal DA D2 receptor occupancy by olanzapine and risperidone in 36 young patients [31 males, 5 females; mean age 21.1 years (16-28)] with first episode schizophrenia, using

  15. An efficacy analysis of olanzapine treatment data in schizophrenia patients with catatonic signs and symptoms.

    Martényi, F; Metcalfe, S; Schausberger, B; Dossenbach, M R


    Thirty-five patients suffering from schizophrenia, as diagnosed by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, were preselected from 7 clinical trials according to a priori criteria of catatonic signs and symptoms based on 3 Positive and Negative Syndrome Scale (PANSS) items: scores for PANSS item 19 (mannerism and posturing) and either item 4 (excitement) or item 21 (motor retardation) had to exceed or equal 4 at baseline. This particular patient population represents a severely psychotic sample: mean +/- SD PANSS total scores at baseline were 129.26 +/- 19.76. After I week of olanzapine treatment, mean PANSS total score was decreased significantly (-13.14; p < .001), as was mean PANSS total score after 6 weeks of olanzapine treatment (-45.16; p < .001); additionally, the positive subscale, negative subscale, and mood scores improved significantly. A significant improvement in the catatonic signs and symptoms composite score was also observed at week 6 (-4.96; p < .001). The mean +/- SD daily dose of olanzapine was 18.00 +/- 2.89 mg after 6 weeks of treatment. The present data analysis suggests the efficacy of olanzapine in the treatment of severely ill schizophrenic patients with nonspecified catatonic signs and symptoms.

  16. The metabolic effects of olanzapine and topiramate in rats and humans

    Evers, S.S.; van Dijk, G.; van Vliet, A.; Scheurink, A.J.W.

    In humans the anti-psychotic Olanzapine (OLZ) has negative side effects on metabolism: it causes weight gain and increases the risk of developing type 2 Diabetes. The anti-convulsant Topiramate (TPM) has the opposite effects: it reduces body weight and improves insulin sensitivity. Because of this,

  17. Olanzapine-Induced Mania in Bipolar Spectrum Disorder:A Case Report

    Mehrdad Eftekhar


    Full Text Available Objective: To report the case of a 46-year old male with major depressive disorder, who represented manic symptoms, when olanzapine was added to his treatment. Method: A 46-year old female, with a diagnosis of treatment resistant depression was referred to the authors. He had past history of depression for more than 20 years. The symptoms were present nearly every day since 1981, without any distinct period of remission, nor any noticeable fluctuation. His irritability had been disruptive to his family all these years. His doctor had prescribed maprotiline 25 mg/day, and lorazepam, 2mg/day, in addition to fluoxetine for the last 5 months. He is also a father of two children with methylphenidateresistant and sodium valproate-responsive attention-deficit hyperactivity disorder. Considering the antidepressant effects of olanzapine and its positive effects on irritability, the authors added olanzapine, to the patient’s previous medications. Results: After one week, he showed new problems such as talkativeness and beginning to smoke for the first time in his life, elevated mood, grandiosity about his intelligence and abilities, talkativeness, and shopping sprees. The score on the mania rating scale was 14. Fluoxetine was discontinued and sodium valproate, were prescribed. It took around 2 months to completely control the manic symptoms. Conclusions: In the patients with depression who show bipolar spectrum disorder features, adding mood stabilizers may be preferred to the drugs as olanzapine which could induce mania.

  18. Olanzapine has better efficacy compared to risperidone for treatment of negative symptoms in schizophrenia

    P N Suresh Kumar


    Conclusions: Both treatments were well-tolerated and efficacious. Greater reductions in severity of the illness and negative symptoms were seen with olanzapine consistently through 1 year. The frequency and severity of extrapyramidal symptoms were negligible and similar in the two treatment groups. Weight gain, hyperlipidemia, and hyperglycemia were comparable in both groups. Risperidone produced significant hyperprolactinemia.

  19. Batch and flow-injection methods for the spectrophotometric determination of olanzapine

    Jasinska, A.; Nalewajko, E


    An indirect batch spectrophotometric and direct flow-injection (FI) visible spectrophotometric methods have been developed for the determination of the novel anti-psychotic drug olanzapine (OLA). The batch method is based on the oxidation of olanzapine by a known excess of potassium hexacyanoferrate(III) in the presence of the mixture of sulphuric and phosphoric acids (1:1 (v/v)). The absorbance of unreacted oxidant is measured at 425 nm. The absorbance decreases linearly with increasing concentration of the assayed drug. The FI method with detection at 540 nm is based on the direct oxidation of olanzapine one of two oxidants, cerium(IV) sulphate or potassium hexacyanoferrate(III) in acidic medium. The calibration graph were linear over the range of 2.5-40 {mu}g ml{sup -1} in the batch method and 0.05-300 and 0.5-250 {mu}g ml{sup -1} in the FI methods, used cerium (IV) sulphate and potassium hexacyanoferrate (III) respectively. Both FI methods gave similar results in terms of precision and accuracy. The relative standard deviation (R.S.D.), was <1%. The accuracy, obtained from recovery experiments, was 97.9-99.4%. The batch method gave slightly higher R.S.D. values (up to 2.3%) and lower values of accuracy (the recovery was between 96.5 and 96.6%). The methods developed were applied to the determination of olanzapine in a pharmaceutical product.

  20. Determination of olanzapine in whole blood using simple protein precipitation and liquid chromatography-tandem mass spectrometry

    Nielsen, Marie Katrine Klose; Johansen, Sys Stybe


    A simple, sensitive, and reproducible liquid chromatography-tandem mass spectrometry method has been developed and validated for the quantification of the antipsychotic drug olanzapine in whole blood using dibenzepine as internal standard (IS). After acidic methanol-induced protein precipitation......, and stability. The absolute recovery obtained was 103% for olanzapine and 68% for IS. An LOQ of 0.005 mg/kg olanzapine in whole blood was achieved. Inter- and intraday precision were less than 11% within concentrations from 0.01 to 0.50 mg/kg, and the accuracy ranged from 85 to 115%. The method was subsequently...

  1. Developing the Pediatric Refractory Epilepsy Questionnaire: a pilot study.

    Purusothaman, Vaishnavi; Ryther, Robin C C; Bertrand, Mary; Harker, Lisa A; Jeffe, Donna B; Wallendorf, Michael; Smyth, Matthew D; Limbrick, David D


    Up to 14% of children with epilepsy continue to experience seizures despite having appropriate medical therapy and develop medically refractory epilepsy (MRE). Assessing clinical outcomes and therapeutic efficacy in children with MRE undergoing palliative epilepsy surgery has been challenging because of the lack of a quantitative instrument capable of estimating the clinical status of these patients. The ideal instrument would at once consider seizure control, neurodevelopment, caregiver burden, and quality of life. The purpose of this study was to develop and pilot the Pediatric Refractory Epilepsy Questionnaire (PREQ), a quantitative instrument to assess the severity and individual burden of epilepsy in children with MRE undergoing palliative epilepsy treatments. The caregivers of 25 patients with MRE completed the PREQ and the Quality of Life in Childhood Epilepsy (QOLCE) measure and participated in a semistructured interview. Medical records of the patients were reviewed, an Early Childhood Epilepsy Severity Scale (E-CHESS) score was calculated, and a Global Assessment of Severity of Epilepsy (GASE) score was obtained for each patient. The initial PREQ was modified based on the analysis of responses, association with previously validated scales, comments from caregivers, and expertise of the PREQ panelists. Pediatric Refractory Epilepsy Questionnaire subscale scores were calculated based on clinical paradigm and compared with independent measures of seizure severity and quality of life. Significant correlations were observed between the seizure severity subscale and the GASE score (r=0.55) and between the mood subscale and the well-being score (r=0.61) on the QOLCE. Significant correlations were also observed between the caregiver rating of seizure severity and the GASE score (r=0.53), the social activity score (r=0.57), and the behavior score (r=0.43) on the QOLCE. Correlations between the caregiver rating of quality of life and the quality of life score (r=0

  2. Do chiropractic college faculty understand informed consent: a pilot study

    Hondras Maria A


    Full Text Available Abstract Background The purpose of this study was to survey full-time faculty at a single chiropractic college concerning their knowledge of Institutional Review Board (IRB policies in their institution as they pertain to educational research. Methods All full-time faculty were invited to participate in an anonymous survey. Four scenarios involving educational research were described and respondents were asked to select from three possible courses of action for each. In addition, respondents were queried about their knowledge of IRB policies, how they learned of these policies and about their years of service and departmental assignments. Results The response rate was 55%. In no scenario did the level of correct answers by all respondents score higher than 41% and in most, the scores were closer to just under 1 in 3. Sixty-five percent of respondents indicated they were unsure whether Palmer had any policies in place at all, while 4% felt that no such policies were in place. Just over one-quarter (27% were correct in noting that students can decline consent, while more than half (54% did not know whether there were any procedures governing student consent. Conclusion Palmer faculty have only modest understanding about institutional policies regarding the IRB and human subject research, especially pertaining to educational research. The institution needs to develop methods to provide knowledge and training to faculty. The results from this pilot study will be instrumental in developing better protocols for a study designed to survey the entire chiropractic academic community.

  3. A pilot study on mindfulness based stress reduction for smokers

    Baker Timothy B


    Full Text Available Abstract Background Mindfulness means paying attention in the present moment, non-judgmentally, without commentary or decision-making. We report results of a pilot study designed to test the feasibility of using Mindfulness Based Stress Reduction (MBSR (with minor modifications as a smoking intervention. Methods MBSR instructors provided instructions in mindfulness in eight weekly group sessions. Subjects attempted smoking cessation during week seven without pharmacotherapy. Smoking abstinence was tested six weeks after the smoking quit day with carbon monoxide breath test and 7-day smoking calendars. Questionnaires were administered to evaluate changes in stress and affective distress. Results 18 subjects enrolled in the intervention with an average smoking history of 19.9 cigarettes per day for 26.4 years. At the 6-week post-quit visit, 10 of 18 subjects (56% achieved biologically confirmed 7-day point-prevalent smoking abstinence. Compliance with meditation was positively associated with smoking abstinence and decreases in stress and affective distress. Discussions and conclusion The results of this study suggest that mindfulness training may show promise for smoking cessation and warrants additional study in a larger comparative trial.

  4. The Hong Kong vision study: a pilot assessment of visual impairment in adults.

    Van Newkirk, M R


    PURPOSE: The Hong Kong Adult Vision Pilot Study is a population based study of the distribution and determinants of eye disease in a random sample of the Chinese population age 40 and over. The present pilot study identifies the extent and causes of visual loss using methods developed in the United States and Australia. The pilot study uses the prevalence data to estimate the sample size necessary to predict the size of an effect a larger study may detect and the confidence with which that ef...

  5. Comparison of clinical outcomes with orodispersible versus standard oral olanzapine tablets in nonadherent patients with schizophrenia or bipolar disorder.

    Novick, Diego; Montgomery, William; Treuer, Tamas; Koyanagi, Ai; Aguado, Jaume; Kraemer, Susanne; Haro, Josep Maria


    Medication nonadherence is common in the treatment of patients with severe mental illness and is a frequent cause of relapse. Different formulations have been developed in an effort to improve medication adherence. The aim of this study was to explore whether there are differential clinical outcomes between two different formulations of olanzapine (orodispersible tablets [ODTs] vs standard oral tablets [SOT]) for the treatment of nonadherent patients with schizophrenia or bipolar disorder. Data for this analysis were from an observational study conducted in Europe (N=903). Adult schizophrenia and bipolar disorder patients in outpatient settings who initiated or changed to either olanzapine ODT or SOT according to physician decision within the last 45 days were eligible for enrollment. The follow-up period was 1 year. Of the 903 participants, 266 nonadherent patients (Medication Adherence Rating Scale score 0-4 at baseline) were included in the analysis. Clinical outcomes of interest were: 1) hospitalization and 2) relapse identified by the participating psychiatrist or hospitalization. An adjusted logistic regression model was fitted. Patients taking ODT had more severe illness at baseline ( P <0.001) as assessed with the Clinical Global Impression with mean (standard deviation [SD]) scores of ODT 4.63 (1.03) and SOT 4 (1.16). In the regression models adjusted for potential confounders, patients taking ODT had significantly lower odds for hospitalization (odds ratio =0.355; 95% confidence interval =0.13-0.974) and relapse or hospitalization (odds ratio =0.368; 95% confidence interval =0.183-0.739), respectively. Nonadherent patients with schizophrenia or bipolar disorder treated with the orodispersible formulation were less likely to be hospitalized or suffer relapse compared to those patients taking the standard oral coated tablets.

  6. A new in situ model to study erosive enamel wear, a clinical pilot study.

    Ruben, J.L.; Truin, G.J.; Bronkhorst, E.M.; Huysmans, M.C.D.N.J.M.


    OBJECTIVES: To develop an in situ model for erosive wear research which allows for more clinically relevant exposure parameters than other in situ models and to show tooth site-specific erosive wear effect of an acid challenge of orange juice on enamel. METHODS: This pilot study included 6

  7. naturalistic study of olanzapine in treatment-resistant schizophrenia



    Feb 2, 2000 ... of some 800,000 mixed race people, of whom the indigenous race ... severity of mania, depression, anxiety and OCD; (ii) the Clinical. Global Impression ... schizophrenia (36 or 56.3%), Bipolar I disorder, manic phase (8 or ...

  8. Oral cancer awareness in Spain: A pilot study.

    Varela-Centelles, P; Estany-Gestal, A; Bugarín-González, R; Seoane-Romero, J M


    To investigate the level of oral cancer knowledge and awareness in a Spanish general population. A cross-sectional study using an anonymous questionnaire applied in the community to randomly selected laypersons. Sample size for the general population was determined by quota sampling, resulting in 1,041 individuals. A total of 1,707 pedestrians were approached (response: 61%). When the participants were asked about what cancers had they heard about (up to ten), oral cancer was mentioned in first place by 2% of the sample and by 22% in any order. When specifically asked about oral cancer, the percentage of interviewees who were familiar with it raised to 72%. Participants were also asked about the main signs or symptoms of oral cancer, and the most frequently (22%) mentioned as the first warning sign was a non-healing ulcer. Tobacco smoking generally was recognised as the most important (57%) risk factor for oral cancer. This pilot study revealed a low awareness of oral cancer, and a poor knowledge of its signs and symptoms and risk factors. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd. All rights reserved.

  9. Task rotation in an underground coal mine: A pilot study.

    Jones, Olivia F; James, Carole L


    Task rotation is used to decrease the risk of workplace injuries and improve work satisfaction. To investigate the feasibility, benefits and challenges of implementing a task rotation schedule within an underground coalmine in NSW, Australia. A mixed method case control pilot study with the development and implementation of a task rotation schedule for 6 months with two work crews. A questionnaire including The Nordic Musculoskeletal Questionnaire, The Need for Recovery after Work Scale, and The Australian WHOQOL- BREF Australian Edition was used to survey workers at baseline, 3 and 6 months. A focus group was completed with the intervention crew and management at the completion of the study. In total, twenty-seven participants completed the survey. Significant improvements in the psychological and environmental domains of the WHOQOL-BREF questionnaire were found in the intervention crew. Musculoskeletal pain was highest in the elbow, lower back and knee, and fatigue scores improved, across both groups. The intervention crew felt 'mentally fresher', 'didn't do the same task twice in a row', and 'had more task variety which made the shift go quickly'. Task rotation was positively regarded, with psychological benefits identified. Three rotations during a 9-hour shift were feasible and practical in this environment.

  10. Thermoacoustic CT of the breast: pilot study observations

    Kruger, Robert A.; Kiser, William L., Jr.; Romilly, A. P.; Scmidt, Phyllis


    In order to assess the potential clinical utility of using thermoacoustic computer tomography (TCT) to image the breast, we conducted a retrospective pilot study of 78 patients. We recruited patients in three age groups (50 years). The study population was further segregated into normal and suspicious based on the results of the previous x-ray mammography and ultrasound. Image quality was evaluated qualitatively by consensus of two trained mammographers using a 4-point scale. The appearance of normal anatomy, cysts, benign disease and cancer was noted. Patients were also asked to rate the comfort of the TCT exam and to indicate a personal preference for x-ray mammography or TCT. Analysis of the data indicated that TCT image quality was dependent upon both patient age and breast density, improving with both increasing breast density and decreasing patient age. Fibrocystic disease was well seen, cysts appearing as areas of low RF absorption. Fibroadenomas did not demonstrate contrast enhancement with the exception of one patient with associated atypical hyperplasia. Cancer displayed higher RF absorption than surrounding tissues in 4/7 patients in whom cancer was confirmed, including one patient with a 7-mm ductal carcinoma in situ (DCIS).

  11. Socioeconomic impact of children's burns-a pilot study.

    Kilburn, Nadia; Dheansa, Baljit


    This pilot study aimed to gain empirical data on the social and economic impacts of child burns on children and parents, in the context of the outpatient setting. A questionnaire was completed by 52 parents of paediatric patients attending the burns outpatient department at Queen Victoria Hospital (QVH), East Grinstead, for at least the third time. Children's medical notes were used to extract demographic and medical data. Quantitative data was analyzed statistically and qualitative data was analyzed manually using content analysis. The financial burden related to the injury posed the greatest impact on parents, and was mainly associated with making the journey to the hospital, with lower income households being most affected. Self-employed parents and those who had to attend more than 6 hospital appointments also ran into difficulties. On the whole, there was not a considerable social impact on the burn-injured child, which may reflect the minor nature of burns in this study (mean depth partial thickness, median TBSA 1.0%). Parents were shown to perceive a greater impact from their child's burn injury than their child. Certain groups of parents were identified as requiring additional support following the burn injury. Copyright © 2014 Elsevier Ltd and ISBI. All rights reserved.

  12. Interproximal periodontal defect model in dogs: a pilot study.

    Jung, U-W; Chang, Y-Y; Um, Y-J; Kim, C-S; Cho, K-S; Choi, S-H


    This study aimed to evaluate the validity of a surgically created interproximal periodontal defect in dogs. Surgery was performed in the interproximal area between the maxillary second and third premolars in two beagle dogs. Following an incision and reflection of the gingival flap, a 3-mm wide and 5-mm high defect was prepared surgically at the interproximal area. A thorough root planing was performed and the flap was coronally positioned and sutured. The contra-lateral area was served as the control with no surgical intervention. After 8 weeks of healing, the animals were killed and the defect was analysed histometrically and radiographically. The interproximal periodontal defect resembled a naturally occurring defect and mimicked a clinical situation. After healing, the defect showed limited bone (0.89±0.02mm) and cementum regeneration (1.50± 0.48mm). Within the limitations of this pilot study, the interproximal periodontal defect showed limited bone and cementum regeneration. Thus, it can be considered as a standardized, reproducible defect model for testing new biomaterials. © 2010 John Wiley & Sons A/S.

  13. Daily personal exposure to black carbon: A pilot study

    Williams, Ryan D.; Knibbs, Luke D.


    Continuous personal monitoring is the benchmark for air pollution exposure assessment. Black carbon (BC) is a strong marker of primary combustion like vehicle and biomass emissions. There have been few studies that quantified daily personal BC exposure and the contribution that different microenvironments make to it. In this pilot study, we used a portable aethalometer to measure BC concentrations in an individual's breathing zone at 30-s intervals while he performed his usual daily activities. We used a GPS and time-activity diary to track where he spent his time. We performed twenty 24-h measurements, and observed an arithmetic mean daily exposure concentration of 603 ng/m3. We estimated that changing commute modes from bus to train reduced the 24-h mean BC exposure concentration by 29%. Switching from open windows to closed windows and recirculated air in a car led to a reduction of 32%. Living in a home without a wood-fired heater caused a reduction of 50% compared with a wood-heated home. Our preliminary findings highlight the potential utility of simple approaches to reduce a person's daily BC exposure.

  14. Observing position and movements in hydrotherapy: a pilot study.

    Stark, Mary Ann; Rudell, Barb; Haus, George


    To observe and describe the positions and movements women choose while immersed in water during the first stage of labor. Descriptive, observational pilot study. A rural community hospital that provided hydrotherapy in labor. Women (N = 7) who intended to use hydrotherapy in labor were recruited prenatally from a midwife-managed practice. For 15 minutes of each hour during the first stage of labor, position and movements of the participants were observed and recorded on a laptop computer. The observational tool was developed for this study from a review of the literature and interviews with nursing experts; 435 observations were recorded. Women were free to choose when and how long to use hydrotherapy and had no restriction on their positions and movements. Only 3 of the 7 participants labored in the tub. Women demonstrated a greater range of positions and movements in the tub than in bed, both throughout labor and during late first-stage labor (7-10 cm of dilatation). Women had more contractions and made more rhythmic movements while in the tub than in bed. Hydrotherapy may encourage upright positions and movements that facilitate labor progress and coping, helping women avoid unnecessary interventions.

  15. A pilot study of bendamustine in advanced bile duct cancer.

    Schoppmeyer, Konrad; Kreth, Florian; Wiedmann, Marcus; Mössner, Joachim; Preiss, Rainer; Caca, Karel


    We performed a pilot study to evaluate the safety and tolerability of bendamustine in patients with advanced hilar bile duct cancer and impaired liver function. Six patients with histologically proven, unresectable adenocarcinoma of the hilar bile duct were treated with bendamustine 140 mg/m intravenously on day 1 of the first cycle and with bendamustine 100 mg/m on days 1 and 2 of the second to fourth cycle. Treatment cycles were repeated every 21 days. Primary endpoint was the safety and tolerability of the treatment; secondary endpoints were response rate, time to progression and overall survival. Transient lymphopenia grade 3 occurred in all six patients. No other grade 3 or 4 toxicities were present. The most common nonhematologic toxicity was mouth dryness grade 2 in six patients. Three patients had stable disease. No partial or complete responses were observed. Median time to progression was 3.3 months; median overall survival was 6 months. Our study demonstrates that bendamustine can be safely administered in patients with hilar bile duct cancer and impaired liver function. A potential role of bendamustine in combination therapies for bile duct cancer will be a subject of further trials.

  16. Leading teams during simulated pediatric emergencies: a pilot study

    Coolen, Ester H; Draaisma, Jos M; den Hamer, Sabien; Loeffen, Jan L


    Purpose Leadership has been identified as a key variable for the functioning of teams and as one of the main reasons for success or failure of team-based work systems. Pediatricians often function as team leaders in the resuscitation of a critically ill child. However, pediatric residents often report having little opportunity to perform in the role of team leader during residency. In order to gain more insight into leadership skills and behaviors, we classified leadership styles of pediatric residents during simulated emergencies. Methods We conducted a prospective quantitative study to investigate leadership styles used by pediatric residents during simulated emergencies with clinical deterioration of a child at a pediatric ward. Using videotaped scenarios of 48 simulated critical events among 12 residents, we were able to classify verbal and nonverbal communication into different leadership styles according to the situational leadership theory. Results The coaching style (mean 54.5%, SD 7.8) is the most frequently applied by residents, followed by the directing style (mean 35.6%, SD 4.1). This pattern conforms to the task- and role-related requirements in our scenarios and it also conforms to the concept of situational leadership. We did not find any significant differences in leadership style according to the postgraduate year or scenario content. Conclusion The model used in this pilot study helps us to gain a better understanding of the development of effective leadership behavior and supports the applicability of situational leadership theory in training leadership skills during residency. PMID:25610010

  17. Olanzapine-associated hypothermia: a case report of a rare event

    Manuel Monti


    Full Text Available Hypothermia, a potentially fatal condition, is defined as a drop of the body temperature below 35°C. The most common cause of severe hypothermia is the environmental exposure to low-temperatures. Other causes include septicemia, diabetic ketoacidosis, trauma, acute spinal cord injury, prolonged cardiac arrest and hypothyroidism. The hypothermia is an infrequent, but previously documented, adverse effect of antipsychotic medications. A 83-year-old Italian woman was transported to the Emergency Room with a reduced level of consciousness, Glasgow coma scale 7. She was bradycardic (heart rate 42 bpm, 80/150 mmHg blood pressure and respiratory rate 26/min. Her physical examination was significant for an anal temperature of 31°C. Blood exam and chest X-ray were unremarkable. In her clinical history, she was suffering from generalized anxiety disorder for the last 2 years and was prescribed olanzapine 7.5 mg daily. In recent days, the patient experienced a cognitive impairment with heat intolerance and had been reduced the dose of olanzapine 5 mg daily. On the basis of the clinical findings, the patient’s body temperature and blood exam, the diagnosis of olanzapine-associated hypothermia was made. The patient was gradually rewarmed with blankets and warm saline infusion and the olanzapine therapy was discontinued. She gradually regained consciousness after 18 h and, after 1 day, the patient’s body temperature increased up to 37.8°C with an improvement of the neurological conditions. We reported about the case of a patient treated with stable doses of olanzapine for a long period of time that developed hypothermia, a potentially fatal complication. This case shows that it is important to consider every change in the patient behavior, e.g., the poor resistance to heat present in our patient, that should exhibit warning sign of hypothermia.

  18. Pilot study to verify the calibration of electrometers

    Becker, P.; Meghzifene, A.


    National Laboratory for Electrical Measurements has not yet developed its capability for the standardization of small electrical charge produced by DC, the IRD is trying to verify its standardization procedures of the electrical charge through a comparison programme. This subject was discussed with a major electrometer manufacturer that has offered to provide free of charge, three of their electrometer calibration standards for a pilot run. The model to be provided consists of four calibrated resistors and two calibrated capacitors, covering the charge/current range of interest. For producing charge or current a standard DC voltage must be applied to these components. Since practically all-modern electrometers measure using virtual ground, this methodology is viable. The IRD, in collaboration with the IAEA, wishes to invite interested laboratories to participate in this pilot comparison programme. This exercise is expected to be useful for all participants and will hopefully open the way for the establishment of routine comparisons in this area. The results will be discussed and published in an appropriate journal. Interested institutions should contact directly Mr. Paulo H. B. Becker through e-mail (pbecker at or fax +55 21 24421950 informing him of the model and manufacturer of the electrometer to be used for the pilot study and discuss all practical details. (author)

  19. Effects of a multidisciplinary group rehabilitation programme on participation of the visually impaired elderly : a pilot study

    Alma, Manna A.; Groothoff, Johan W.; Melis-Dankers, Bart J. M.; Post, Marcel W. M.; Suurmeijer, Theo P. B. M.; van der Mei, Sijrike F.


    Purpose: To pilot test the newly developed multidisciplinary group rehabilitation programme Visually Impaired elderly Persons Participating (VIPP). Method: A single group pretest-posttest design pilot study included 29 visually impaired persons (>= 55 years). The intervention (20 weekly meetings)

  20. Pilot case-control study of paediatric falls from windows.

    Johnston, Brian D; Quistberg, D Alexander; Shandro, Jamie R; Partridge, Rebecca L; Song, Hyun Rae; Ebel, Beth E


    Unintentional falls from windows are an important cause of paediatric morbidity. There have been no controlled studies to identify modifiable environmental risk factors for window falls in young children. The authors have piloted a case-control study to test procedures for case identification, subject enrolment, and environmental data collection. Case windows were identified when a child 0-9 years old presented for care after a fall from that window. Control windows were identified (1) from the child's home and (2) from the home of an age- and gender-matched child seeking care for an injury diagnosis not related to a window fall. Study staff visited enrolled homes to collect window measurements and conduct window screen performance tests. The authors enrolled and collected data on 18 case windows, 18 in-home controls, and 14 matched community controls. Six potential community controls were contacted for every one enrolled. Families who completed the home visit viewed study procedures positively. Case windows were more likely than community controls to be horizontal sliders (100% vs 50%), to have deeper sills (6.28 vs 4.31 inches), to be higher above the exterior surface (183 vs 82 inches), and to have screens that failed below a threshold derived from the static pressure of a 3-year-old leaning against the mesh (60.0% vs 16.7%). Case windows varied very little from in-home controls. Case-control methodology can be used to study risk factors for paediatric falls from windows. Recruitment of community controls is challenging but essential, because in-home controls tend to be over-matched on important variables. A home visit allows direct measurement of window type, height, sill depth, and screen performance. These variables should all be investigated in subsequent, larger studies covering major housing markets.

  1. Visual consequences of electronic reader use: a pilot study.

    Maducdoc, Marlon M; Haider, Asghar; Nalbandian, Angèle; Youm, Julie H; Morgan, Payam V; Crow, Robert W


    With the increasing prevalence of electronic readers (e-readers) for vocational and professional uses, it is important to discover if there are visual consequences in the use of these products. There are no studies in the literature quantifying the incidence or severity of eyestrain, nor are there clinical characteristics that may predispose to these symptoms with e-reader use. The primary objective of this pilot study was to assess the degree of eyestrain associated with e-reader use compared to traditional paper format. The secondary outcomes of this study were to assess the rate of eyestrain associated with e-reader use and identify any clinical characteristics that may be associated with the development of eyestrain. Forty-four students were randomly assigned to study (e-reader iPAD) and control (print) groups. Participant posture, luminosity of the room, and reading distance from reading device were measured during a 1-h session for both groups. At the end of the session, questionnaires were administered to determine symptoms. Significantly higher rates of eyestrain (p = 0.008) and irritation (p = 0.011) were found among the iPAD study group as compared to the print 'control' group. The study group was also 4.9 times more likely to report severe eyestrain (95 % CI [1.4, 16.9]). No clinical characteristics predisposing to eyestrain could be identified. These findings conclude that reading on e-readers may induce increased levels of irritation and eyestrain. Predisposing factors, etiology, and potential remedial interventions remain to be determined.

  2. Lung cancer correlates in Lebanese adults: A pilot case–control study

    Joseph Aoun


    Conclusion: In this pilot study, it was found that in addition to smoking, outdoor and indoor pollution factors were potential risk factors of lung cancer. Additional studies would be necessary to confirm these findings.

  3. Customized photorefractive keratectomy to correct high ametropia after penetrating keratoplasty: A pilot study

    Giuseppe De Rosa


    Conclusion: Our pilot study suggests that customized PRK can be a safe and effective method for treating ametropia and irregular astigmatisms after PK. Future studies with larger samples and longer follow-ups should be performed to confirm these results.

  4. Arctic Ice Dynamics Joint Experiment (AIDJEX) Second Pilot Study, March - May 1972: A Documentary Film

    National Oceanic and Atmospheric Administration, Department of Commerce — The project described in this documentary was a pilot study conducted in 1972 in preparation for the AIDJEX main experiment of 1975 to 1976. The study included a...

  5. Adjustable recessions in horizontal comitant strabismus: A pilot study

    Siddharth Agrawal


    Full Text Available Aim: To compare the surgical outcome of adjustable with the conventional recession in patients with horizontal comitant strabismus. Patients and Methods: A prospective comparative nonrandomized interventional pilot study was performed on patients with horizontal comitant strabismus. Fifty-four patients (27 in each group were allocated into 2 groups to undergo either adjustable suture (AS recession or non-AS (NAS recession along with conventional resection. The patients were followed up for 6 months. A successful outcome was defined as deviation ±10 prism diopters at 6 months. The results were statistically analyzed by Chi-square test, Fisher′s exact test, and Student′s t-test. Results: A successful outcome was found in 24 (88.8% patients in AS and 17 (62.9% in NAS group (P = 0.02. The postoperative adjustment was done in 13 (48.1% patients in AS group. There was one complication (tenon′s cyst in AS group. Conclusion: AS recession may be considered in all cooperative patients undergoing strabismus surgery for comitant deviations.

  6. Perceived harmfulness of substance use: A pilot study

    Siddharth Sarkar


    Full Text Available Background: Harm ratings of substances help in understanding the perception toward substance use and formulating policies. Evidence of such harm ratings by substance users and their caregivers provides a clearer perspective of those who experience and observe such harm closely. Materials and Methods: Substance users and their caregivers were recruited from the Drug De-addiction and Treatment Centre of PGIMER, Chandigarh. Sociodemographic details of the subjects were noted. The subjects were then asked to rate a list of psychoactive preparations according to the harms they thought the preparation caused. The list of substances was developed taking into consideration substance commonly encountered in the geographical area. The harm ratings were transformed on a scale of 0-100. Results: All subjects were males and majority of them were educated above 10 th standard, were not employed and belonged to urban background. Most of them had taken psychoactive substances in their lifetimes but were currently abstinent. Most of the subjects endorsed intravenous drugs as the most harmful, followed by heroin. Beer and chewable tobacco considered the least harmful substances. Greater degree of education was associated with lower harm rankings for heroin, cannabis, dextropropoxyphene, and raw opium; while urban residence was associated with greater harm ratings for cannabis and raw opium. Differences in the harms were perceived for different preparations of the same active compound for alcohol and nicotine. Conclusion: Harm ratings of substances can be a useful guide while formulating policies and allocating resources. Need for further research extending this pilot study is emphasized.

  7. Evaluating and operationalizing an environmental auditing program: a pilot study.

    Gordon, Laura; Bruce, Natalie; Suh, Kathryn N; Roth, Virginia


    Environmental auditing is an important tool to ensure consistent and effective cleaning. Our pilot study compared an alcohol-based fluorescent marking product and an adenosine-5'-triphosphate bioluminescence product for use in an environmental auditing program to determine which product was more practical and acceptable to users. Both products were tested on 15 preselected high touch objects in randomly selected patient rooms, following regular daily cleaning. A room was considered a "pass" if ≥80% of surfaces were adequately cleaned as defined by manufacturers' guidelines. A qualitative survey assessed user preference and operational considerations. Using fluorescent marking, 9 of 37 patient rooms evaluated (24%) were considered a "pass" after daily cleaning. Using adenosine-5'-triphosphate bioluminescence, 21 of 37 patient rooms passed (57%). There was great variability in results between different high touch objects. Eighty percent of users preferred the alcohol-based fluorescent marking product because it provided an effective visual aid to coach staff on proper cleaning techniques and allowed simple and consistent application. Environmental auditing using translucent, alcohol-based fluorescent marking best met the requirements of our organization. Our results reinforce the importance of involving a multidisciplinary team in evaluating and operationalizing an environmental auditing program. Copyright © 2014 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Mosby, Inc. All rights reserved.

  8. Pilot study on microvascular anastomosis: performance and future educational prospects.

    Berretti, G; Colletti, G; Parrinello, G; Iavarone, A; Vannucchi, P; Deganello, A


    The introduction of microvascular free flaps has revolutionised modern reconstructive surgery. Unfortunately, access to training opportunities at standardised training courses is limited and expensive. We designed a pilot study on microvascular anastomoses with the aim of verifying if a short course, easily reproducible, could transmit microvascular skills to participants; if the chosen pre-test was predictive of final performance; and if age could influence the outcome. A total of 30 participants (10 students, 10 residents and 10 surgeons) without any previous microvascular experience were instructed and tested during a single 3 to 5 hour course. The two microanastomoses evaluated were the first ever performed by each participant. More than the half of the cohort was able to produce both patent microanastomoses in less than 2 hours; two-thirds of the attempted microanastomoses were patent. The pretest predicted decent scores from poor performances with a sensitivity of 61.5%, specificity of 100%, positive predictive value of 100% and negative predictive value of 40%. Students and residents obtained significantly higher scores than surgeons. Since our course model is short, cost-effective and highly reproducible, it could be introduced and implemented anywhere as an educational prospect for preselecting young residents showing talent and natural predisposition and having ambitions towards microvascular reconstructive surgery. © Copyright by Società Italiana di Otorinolaringologia e Chirurgia Cervico-Facciale.

  9. Sociomoral Reasoning in Adults with ADHD: A Pilot Study

    Kate E. Thomason


    Full Text Available Attention Deficit Hyperactivity Disorder (ADHD is frequently linked with antisocial behaviour, yet less is known about its relationship with sociomoral reasoning, and the possible mediating effect of intelligence. A pilot study was designed to investigate the relationship between antisocial personality traits, intelligence and sociomoral reasoning in adults with ADHD. Twenty two adults with ADHD and 21 healthy controls, matched for age, gender and IQ completed a battery of measures including the National Adult Reading Test, Gough Socialisation Scale and Sociomoral Reflection Measure-Short Form. There was no difference between the groups and levels of sociomoral reasoning, despite the ADHD group reporting greater antisocial personality traits. Sociomoral reasoning was positively correlated with intelligence. Results from a hierarchical multiple regressions indicated that both antisocial traits and IQ were significant predictors of sociomoral reasoning, with IQ proving the most powerful predictor. Whilst antisocial personality traits may explain some of the variance in levels of sociomoral reasoning, a diagnosis of ADHD does not appear to hinder the development of mature moral reasoning. Intellectual functioning appears to facilitate the development of sociomoral reasoning. A further analysis showed that both ADHD and low sociomoral reasoning were significant predictors of antisocial traits. The current findings have important treatment implications.

  10. Gene Expression Correlation for Cancer Diagnosis: A Pilot Study

    Binbing Ling


    Full Text Available Poor prognosis for late-stage, high-grade, and recurrent cancers has been motivating cancer researchers to search for more efficient biomarkers to identify the onset of cancer. Recent advances in constructing and dynamically analyzing biomolecular networks for different types of cancer have provided a promising novel strategy to detect tumorigenesis and metastasis. The observation of different biomolecular networks associated with normal and cancerous states led us to hypothesize that correlations for gene expressions could serve as valid indicators of early cancer development. In this pilot study, we tested our hypothesis by examining whether the mRNA expressions of three randomly selected cancer-related genes PIK3C3, PIM3, and PTEN were correlated during cancer progression and the correlation coefficients could be used for cancer diagnosis. Strong correlations (0.68≤r≤1.0 were observed between PIK3C3 and PIM3 in breast cancer, between PIK3C3 and PTEN in breast and ovary cancers, and between PIM3 and PTEN in breast, kidney, liver, and thyroid cancers during disease progression, implicating that the correlations for cancer network gene expressions could serve as a supplement to current clinical biomarkers, such as cancer antigens, for early cancer diagnosis.

  11. GLOBE Aerosol Field Campaign - U.S. Pilot Study 2016

    Pippin, Margaret; Marentette, Christina; Bujosa, Robert; Taylor, Jessica; Lewis, Preston


    During the spring of 2016, from April 4 - May 27, sixteen GLOBE schools participated in the GLOBE Aerosol Field Campaign - U.S. Pilot Study. Thirteen teachers from these schools had previously participated in the NASA LEARN program (Long-term Experience in Authentic Research with NASA) where they were GLOBE trained in Atmosphere protocols, and engaged in 1-3 years of research under the mentorship of NASA scientists. Each school was loaned two aerosol instruments for the Campaign duration, either 2 GLOBE sun photometers, 2 Calitoo sun photometers, or 1 of each. This allowed for students to make measurements side-by-side and in the case of the Calitoos, to compare AOT results immediately with each other for better consistency in data collection. Additionally, as part of the Field Campaign evaluation, multiple instruments allow for an assessment of the ease of use of each instrument for grade level of students, whether in middle school or high school. Before the Campaign, all GLOBE and Calitoo instruments were 'checked out' against an AERONET, then checked again upon return after the Campaign. By examining all data, before, during and after the Campaign, this gives an indication of instrument performance and proficiency obtained by the students. Support was provided to each teacher and their students at the level requested, via email, phone or video conferencing.

  12. Compensatory stepping responses in individuals with stroke: a pilot study.

    Lakhani, Bimal; Mansfield, Avril; Inness, Elizabeth L; McIlroy, William E


    Impaired postural control and a high incidence of falls are commonly observed following stroke. Compensatory stepping responses are critical to reactive balance control. We hypothesize that, following a stroke, individuals with unilateral limb dyscontrol will be faced with the unique challenge of controlling such rapid stepping reactions that may eventually be linked to the high rate of falling. The objectives of this exploratory pilot study were to investigate compensatory stepping in individuals poststroke with regard to: (1) choice of initial stepping limb (paretic or non-paretic); (2) step characteristics; and (3) differences in step characteristics when the initial step is taken with the paretic vs. the non-paretic limb. Four subjects following stroke (38-165 days post) and 11 healthy young adults were recruited. Anterior and posterior perturbations were delivered by using a weight drop system. Force plates recorded centre-of-pressure excursion prior to the onset of stepping and step timing. Of the four subjects, three only attempted to step with their non-paretic limb and one stepped with either limb. Time to foot-off was generally slow, whereas step onset time and swing time were comparable to healthy controls. Two of the four subjects executed multistep responses in every trial, and attempts to force stepping with the paretic limb were unsuccessful in three of the four subjects. Despite high clinical balance scores, these individuals with stroke demonstrated impaired compensatory stepping responses, suggesting that current clinical evaluations might not accurately reflect reactive balance control in this population.

  13. A Problem Solving Intervention for hospice caregivers: a pilot study.

    Demiris, George; Oliver, Debra Parker; Washington, Karla; Fruehling, Lynne Thomas; Haggarty-Robbins, Donna; Doorenbos, Ardith; Wechkin, Hope; Berry, Donna


    The Problem Solving Intervention (PSI) is a structured, cognitive-behavioral intervention that provides people with problem-solving coping skills to help them face major negative life events and daily challenges. PSI has been applied to numerous settings but remains largely unexplored in the hospice setting. The aim of this pilot study was to demonstrate the feasibility of PSI targeting informal caregivers of hospice patients. We enrolled hospice caregivers who were receiving outpatient services from two hospice agencies. The intervention included three visits by a research team member. The agenda for each visit was informed by the problem-solving theoretical framework and was customized based on the most pressing problems identified by the caregivers. We enrolled 29 caregivers. Patient's pain was the most frequently identified problem. On average, caregivers reported a higher quality of life and lower level of anxiety postintervention than at baseline. An examination of the caregiver reaction assessment showed an increase of positive esteem average and a decrease of the average value of lack of family support, impact on finances, impact on schedules, and on health. After completing the intervention, caregivers reported lower levels of anxiety, improved problem solving skills, and a reduced negative impact of caregiving. Furthermore, caregivers reported high levels of satisfaction with the intervention, perceiving it as a platform to articulate their challenges and develop a plan to address them. Findings demonstrate the value of problem solving as a psycho-educational intervention in the hospice setting and call for further research in this area.

  14. Diabetic Retinopathy Screening Using Telemedicine Tools: Pilot Study in Hungary

    Dóra J. Eszes


    Full Text Available Introduction. Diabetic retinopathy (DR is a sight-threatening complication of diabetes. Telemedicine tools can prevent blindness. We aimed to investigate the patients’ satisfaction when using such tools (fundus camera examination and the effect of demographic and socioeconomic factors on participation in screening. Methods. Pilot study involving fundus camera screening and self-administered questionnaire on participants’ experience during fundus examination (comfort, reliability, and future interest in participation, as well as demographic and socioeconomic factors was performed on 89 patients with known diabetes in Csongrád County, a southeastern region of Hungary. Results. Thirty percent of the patients had never participated in any ophthalmological screening, while 25.7% had DR of some grade based upon a standard fundus camera examination and UK-based DR grading protocol (Spectra™ software. Large majority of the patients were satisfied with the screening and found it reliable and acceptable to undertake examination under pupil dilation; 67.3% were willing to undergo nonmydriatic fundus camera examination again. There was a statistically significant relationship between economic activity, education and marital status, and future interest in participation. Discussion. Participants found digital retinal screening to be reliable and satisfactory. Telemedicine can be a strong tool, supporting eye care professionals and allowing for faster and more comfortable DR screening.

  15. Effects of Aquajogging in Obese Adults: A Pilot Study

    Eveline J. M. Wouters


    Full Text Available Aim and Method. To examine in obese people the potential effectiveness of a six-week, two times weekly aquajogging program on body composition, fitness, health-related quality of life, and exercise beliefs. Fifteen otherwise healthy obese persons participated in a pilot study. Results. Total fat mass and waist circumference decreased 1.4 kg (P=.03 and 3.1 cm (P=.005, respectively. The distance in the Six-Minute Walk Test increased 41 meters (P=.001. Three scales of the Impact of Weight on Quality of Life-Lite questionnaire improved: physical function (P=.008, self-esteem (P=.004, and public distress (P=.04. Increased perceived exercise benefits (P=.02 and decreased embarrassment (P=.03 were observed. Conclusions. Aquajogging was associated with reduced body fat and waist circumference and improved aerobic fitness and quality of life. These findings suggest the usefulness of conducting a randomized controlled trial with long-term outcome assessments.

  16. Microwave Imaging of Human Forearms: Pilot Study and Image Enhancement

    Colin Gilmore


    Full Text Available We present a pilot study using a microwave tomography system in which we image the forearms of 5 adult male and female volunteers between the ages of 30 and 48. Microwave scattering data were collected at 0.8 to 1.2 GHz with 24 transmitting and receiving antennas located in a matching fluid of deionized water and table salt. Inversion of the microwave data was performed with a balanced version of the multiplicative-regularized contrast source inversion algorithm formulated using the finite-element method (FEM-CSI. T1-weighted MRI images of each volunteer’s forearm were also collected in the same plane as the microwave scattering experiment. Initial “blind” imaging results from the utilized inversion algorithm show that the image quality is dependent on the thickness of the arm’s peripheral adipose tissue layer; thicker layers of adipose tissue lead to poorer overall image quality. Due to the exible nature of the FEM-CSI algorithm used, prior information can be readily incorporated into the microwave imaging inversion process. We show that by introducing prior information into the FEM-CSI algorithm the internal anatomical features of all the arms are resolved, significantly improving the images. The prior information was estimated manually from the blind inversions using an ad hoc procedure.

  17. Intraoperative music application in children and adolescents - a pilot study.

    Buehler, P K; Spielmann, N; Buehrer, S; Schmidt, A R; Weiss, M; Schmitz, A


    Hospitalization, surgery and anaesthesia may lead to new-onset maladaptive behaviour, emotional distress and trauma. This pilot study aims to investigate the influence of intraoperatively applied music on post-operative behaviour in children and adolescents. Children with an ASA physical state classification of I or II, aged from 4 to 16 years and scheduled for elective circumcision or inguinal hernia repair under combined general and caudal anaesthesia were included. The children were randomized into two groups. They wore headphones during surgery, and were either exposed to music or not. All involved staff were blinded. Post-operative behaviour was documented by parents on day 7, 14 and 28 after surgery, using a questionnaire adapted from the "Post Hospitalization Behavioural Questionnaire" (PHBQ). Overall occurrence of at least one item indicating maladaptive behaviour was the primary outcome. Data are presented as median (interquartile range). In total, 135 children aged 6.6 (5.3-8.5) years, weighing 22 (19-29) kg, were included, with 112 completed questionnaires returned. Overall occurrence of at least one maladaptive item was lower in the music group, with a significantly lower incidence on day 7 (51% vs. 77% in controls; P music application in children undergoing minor surgical procedures may reduce the incidence of post-operative maladaptive behaviour within the first week. © 2017 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

  18. Intensive mothering ideology in France: A pilot study.

    Loyal, D; Sutter Dallay, A-L; Rascle, N


    The aim of this pilot study was to adapt the intensive mothering ideology concept in a French sample and to get an assessment tool. First, the Intensive Parenting Attitudes Questionnaire (IPAQ), a U.S. scale comprising 25 items, was translated and submitted online to French mothers and mothers-to-be (n=250). Structural validity was tested through confirmatory factor analysis with poor results. Secondly, to increase the cultural validity of a new tool, new items were derived from French women speech. French mothers and mothers-to-be (n=22) were asked about their views regarding motherhood and childcare (semi-structured interviews). A thematic content analysis was performed with good inter-judge agreement (0.53-0.86) and 27 items were created. Finally, the total set of 52 items was submitted online to French mothers and mothers-to-be (n=474). The structure was tested through exploratory factor analysis. A new tool called the Measure of Intensive Mothering Ideology (MIMI) was obtained. This 21 items scale with 6 dimensions (Essentialism, Consuming Fulfillment, Child-centrism, Challenge, Sacrifice and Stimulation) explains 59.75% of variance. Internal consistencies were satisfactory (0.61-0.83) and most dimensions were positively and moderately correlated (0.17-0.38). The MIMI is the first French-language scale assessing IMI and offers interesting research avenues notably regarding perinatal parental adaptation. Copyright © 2017 L'Encéphale, Paris. Published by Elsevier Masson SAS. All rights reserved.

  19. NEREDA Pilot Studies 2003 - 2010; NEREDA Pilotonderzoeken 2003 - 2010

    Berkhof, D.; De Bruin, B.; Kerstholt, M.; Kraan, R.; Miska, V.; Peeters, T.; Van der Roest, H.; Verschoor, J. [DHV, Amersfoort (Netherlands); De Kreuk, M.; Van Loosdrecht, M. [Technische Universiteit Delft TUD, Delft (Netherlands)


    Since the nineties of last century research has been conducted on the development of the aerobic granular sludge technology for wastewater treatment. A first STOWA pilot research project was executed at Ede, Netherlands. In 2005 a technological breakthrough was accomplished and was the starting sign for a broader national development program (NNOP). Next to STOWA, Delft University of Delft and DHV, six Waterboards are involved within this development program. Main goal of the NNOP is to develop a new competitive biological wastewater treatment technology (Nereda). After the Ede project additional pilot research projects were conducted at four locations in the Netherlands. Within these pilot research projects the following aspects were investigated: granulation on different wastewater types; stability of granular sludge; optimization of nitrogen and phosphate removal, especially during winter time; control of effluent suspended solids concentration; and obtain technological design parameters for full scale WWTPs (waste water treatment plants) [Dutch] In dit rapport staan de resultaten beschreven van de tussen 2003 en 2010 uitgevoerde pilots met de aeroob-korrelslibtechnologie Nereda. Dit is een nieuwe zuiveringstechnologie waarbij het reinigende actief slib geen vlokken maar korrels vormt. Hierdoor bezinkt het slib sneller en makkelijker. De technologie wordt gekenmerkt door hoge zuiveringsrendementen, weinig ruimtebeslag (voor bezinking) en relatief lage energiekosten. De resultaten van de pilots zijn dermate goed, dat drie van de vijf deelnemende waterschappen hebben besloten om 1 van hun rwzi's (rioolwaterzuiveringsinstallaties) aan te passen op basis van de Nereda-technologie.

  20. A pilot study to delimit tsetse target populations in Zimbabwe.

    Gerald Chikowore


    Full Text Available Tsetse (Glossina sensu stricto are cyclical vectors of human and animal trypanosomoses, that are presently targeted by the Pan African Tsetse and Trypanosomiasis Eradication Campaign (PATTEC coordinated by the African Union. In order to achieve effective control of tsetse, there is need to produce elaborate plans to guide intervention programmes. A model intended to aid in the planning of intervention programmes and assist a fuller understanding of tsetse distribution was applied, in a pilot study in the Masoka area, Mid-Zambezi valley in Zimbabwe, and targeting two savannah species, Glossina morsitans morsitans and Glossina pallidipes.The field study was conducted between March and December 2015 in 105 sites following a standardized grid sampling frame. Presence data were used to study habitat suitability of both species based on climatic and environmental data derived from MODIS and SPOT 5 satellite images. Factors influencing distribution were studied using an Ecological Niche Factor Analysis (ENFA whilst habitat suitability was predicted using a Maximum Entropy (MaxEnt model at a spatial resolution of 250 m. Area Under the Curve (AUC, an indicator of model performance, was 0.89 for G. m. morsitans and 0.96 for G. pallidipes. We then used the predicted suitable areas to calculate the probability that flies were really absent from the grid cells where they were not captured during the study based on a probability model using a risk threshold of 0.05. Apart from grid cells where G. m. morsitans and G. pallidipes were captured, there was a high probability of presence in an additional 128 km2 and 144 km2 respectively.The modelling process promised to be useful in optimizing the outputs of presence/absence surveys, allowing the definition of tsetse infested areas with improved accuracy. The methodology proposed here can be extended to all the tsetse infested parts of Zimbabwe and may also be useful for other PATTEC national initiatives in other

  1. Treatment-completion rates with olanzapine long-acting injection versus risperidone long-acting injection in a 12-month, open-label treatment of schizophrenia: indirect, exploratory comparisons

    Ascher-Svanum H


    Full Text Available Haya Ascher-Svanum1, William S Montgomery2, David P McDonnell3, Kristina A Coleman4, Peter D Feldman11Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA; 2Eli Lilly Australia Pty Ltd, West Ryde, New South Wales, Australia; 3Eli Lilly and Company, Cork, Ireland; 4OptumInsight, Lilyfield, New South Wales, AustraliaBackground: Little is known about the comparative effectiveness of atypical antipsychotics in long-acting injection formulation. Due to the absence of head-to-head studies comparing olanzapine long-acting injection and risperidone long-acting injection, this study was intended to make exploratory, indirect, cross-study comparisons between the long-acting formulations of these two atypical antipsychotics in their effectiveness in treating patients with schizophrenia.Methods: Indirect, cross-study comparisons between olanzapine long-acting injection and risperidone long-acting injection used 12-month treatment-completion rates, because discontinuation of an antipsychotic for any cause is a recognized proxy measure of the medication's effectiveness in treating schizophrenia. Following a systematic review of the literature, two indirect comparisons were conducted using open-label, single-cohort studies in which subjects were stabilized on an antipsychotic medication before depot initiation. The first analysis compared olanzapine long-acting injection (one study with pooled data from nine identified risperidone long-acting injection studies. The second analysis was a “sensitivity analysis,” using only the most similar studies, one for olanzapine long-acting injection and one for risperidone long-acting injection, which shared near-identical study designs and involved study cohorts with near-identical patient characteristics. Pearson Chi-square tests assessed group differences on treatment-completion rates.Results: Comparison of olanzapine long-acting injection data (931 patients with the pooled data from the nine

  2. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework.

    Sandra M Eldridge

    Full Text Available We describe a framework for defining pilot and feasibility studies focusing on studies conducted in preparation for a randomised controlled trial. To develop the framework, we undertook a Delphi survey; ran an open meeting at a trial methodology conference; conducted a review of definitions outside the health research context; consulted experts at an international consensus meeting; and reviewed 27 empirical pilot or feasibility studies. We initially adopted mutually exclusive definitions of pilot and feasibility studies. However, some Delphi survey respondents and the majority of open meeting attendees disagreed with the idea of mutually exclusive definitions. Their viewpoint was supported by definitions outside the health research context, the use of the terms 'pilot' and 'feasibility' in the literature, and participants at the international consensus meeting. In our framework, pilot studies are a subset of feasibility studies, rather than the two being mutually exclusive. A feasibility study asks whether something can be done, should we proceed with it, and if so, how. A pilot study asks the same questions but also has a specific design feature: in a pilot study a future study, or part of a future study, is conducted on a smaller scale. We suggest that to facilitate their identification, these studies should be clearly identified using the terms 'feasibility' or 'pilot' as appropriate. This should include feasibility studies that are largely qualitative; we found these difficult to identify in electronic searches because researchers rarely used the term 'feasibility' in the title or abstract of such studies. Investigators should also report appropriate objectives and methods related to feasibility; and give clear confirmation that their study is in preparation for a future randomised controlled trial designed to assess the effect of an intervention.

  3. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework.

    Eldridge, Sandra M; Lancaster, Gillian A; Campbell, Michael J; Thabane, Lehana; Hopewell, Sally; Coleman, Claire L; Bond, Christine M


    We describe a framework for defining pilot and feasibility studies focusing on studies conducted in preparation for a randomised controlled trial. To develop the framework, we undertook a Delphi survey; ran an open meeting at a trial methodology conference; conducted a review of definitions outside the health research context; consulted experts at an international consensus meeting; and reviewed 27 empirical pilot or feasibility studies. We initially adopted mutually exclusive definitions of pilot and feasibility studies. However, some Delphi survey respondents and the majority of open meeting attendees disagreed with the idea of mutually exclusive definitions. Their viewpoint was supported by definitions outside the health research context, the use of the terms 'pilot' and 'feasibility' in the literature, and participants at the international consensus meeting. In our framework, pilot studies are a subset of feasibility studies, rather than the two being mutually exclusive. A feasibility study asks whether something can be done, should we proceed with it, and if so, how. A pilot study asks the same questions but also has a specific design feature: in a pilot study a future study, or part of a future study, is conducted on a smaller scale. We suggest that to facilitate their identification, these studies should be clearly identified using the terms 'feasibility' or 'pilot' as appropriate. This should include feasibility studies that are largely qualitative; we found these difficult to identify in electronic searches because researchers rarely used the term 'feasibility' in the title or abstract of such studies. Investigators should also report appropriate objectives and methods related to feasibility; and give clear confirmation that their study is in preparation for a future randomised controlled trial designed to assess the effect of an intervention.

  4. A Pilot Study of Omalizumab in Eosinophilic Esophagitis

    Loizou, Denise; Enav, Benjamin; Komlodi-Pasztor, Edina; Hider, Pamela; Kim-Chang, Julie; Noonan, Laura; Taber, Tabitha; Kaushal, Suhasini; Limgala, Renuka; Brown, Margaret; Gupta, Raavi; Balba, Nader; Goker-Alpan, Ozlem; Khojah, Amer; Alpan, Oral


    Eosinophilic disorders of the gastrointestinal tract are an emerging subset of immune pathologies within the spectrum of allergic inflammation. Eosinophilic Esophagitis (EoE), once considered a rare disease, is increasing in incidence, with a rate of over 1 in 10,000 in the US, for unknown reasons. The clinical management of EoE is challenging, thus there is an urgent need for understanding the etiology and pathophysiology of this eosinophilic disease to develop better therapeutic approaches. In this open label, single arm, unblinded study, we evaluated the effects of an anti-IgE treatment, omalizumab, on local inflammation in the esophagus and clinical correlates in patients with EoE. Omalizumab was administered for 12 weeks to 15 subjects with long standing EoE. There were no serious side effects from the treatment. Esophageal tissue inflammation was assessed both before and after therapy. After 3 months on omalizumab, although tissue Immunoglobulin E (IgE) levels were significantly reduced in all but two of the subjects, we found that full remission of EoE, which is defined as histologic and clinical improvement only in 33% of the patients. The decrease in tryptase-positive cells and eosinophils correlated significantly with the clinical outcome as measured by improvement in endoscopy and symptom scores, respectively. Omalizumab-induced remission of EoE was limited to subjects with low peripheral blood absolute eosinophil counts. These findings demonstrate that in a subset of EoE patients, IgE plays a role in the pathophysiology of the disease and that anti-IgE therapy with omalizumab may result in disease remission. Since this study is open label there is the potential for bias, hence the need for a larger double blind placebo controlled study. The data presented in this pilot study provides a foundation for proper patient selection to maximize clinical efficacy. Trial Registration NCT01040598 PMID:25789989

  5. A pilot study of omalizumab in eosinophilic esophagitis.

    Denise Loizou

    Full Text Available Eosinophilic disorders of the gastrointestinal tract are an emerging subset of immune pathologies within the spectrum of allergic inflammation. Eosinophilic Esophagitis (EoE, once considered a rare disease, is increasing in incidence, with a rate of over 1 in 10,000 in the US, for unknown reasons. The clinical management of EoE is challenging, thus there is an urgent need for understanding the etiology and pathophysiology of this eosinophilic disease to develop better therapeutic approaches. In this open label, single arm, unblinded study, we evaluated the effects of an anti-IgE treatment, omalizumab, on local inflammation in the esophagus and clinical correlates in patients with EoE. Omalizumab was administered for 12 weeks to 15 subjects with long standing EoE. There were no serious side effects from the treatment. Esophageal tissue inflammation was assessed both before and after therapy. After 3 months on omalizumab, although tissue Immunoglobulin E (IgE levels were significantly reduced in all but two of the subjects, we found that full remission of EoE, which is defined as histologic and clinical improvement only in 33% of the patients. The decrease in tryptase-positive cells and eosinophils correlated significantly with the clinical outcome as measured by improvement in endoscopy and symptom scores, respectively. Omalizumab-induced remission of EoE was limited to subjects with low peripheral blood absolute eosinophil counts. These findings demonstrate that in a subset of EoE patients, IgE plays a role in the pathophysiology of the disease and that anti-IgE therapy with omalizumab may result in disease remission. Since this study is open label there is the potential for bias, hence the need for a larger double blind placebo controlled study. The data presented in this pilot study provides a foundation for proper patient selection to maximize clinical efficacy.

  6. Free online otolaryngology educational modules: a pilot study.

    Cabrera-Muffly, Cristina; Bryson, Paul C; Sykes, Kevin J; Shnayder, Yelizaveta


    Otolaryngology residents need concise, easily accessible modules to expand educational opportunities between surgical cases. These modules should be inexpensive to create and improve learning outcomes. The purpose of this pilot study was to assess whether otolaryngology residents at multiple institutions used online video modules to supplement their studying for the Otolaryngology Training Exam, whether the modules had any effect on their Otolaryngology Training Examination Scores, and to obtain survey feedback about the modules. This randomized trial was conducted in 3 academic departments of otolaryngology in the United States among 37 residents enrolled in 3 otolaryngology residency programs. Residents were randomized into 2 groups, one with access to the educational modules and the other with no access. Otolaryngology training examination scores were obtained from the year prior to the intervention (2012) and the year following module access (2013). Residents with access to the modules were also surveyed to assess use and obtain feedback about the modules. Otolaryngology training examination scores improved significantly from 2012 to 2013 among both residents who had access to the modules and those who did not in the sections of head and neck, laryngology, and sleep medicine. However, scores in the sections of pediatric otolaryngology (8% increase, P = .03), otology (7% increase, P = .02), and facial plastic surgery (10% increase, P = .02) improved from 2012 to 2013 only among residents with access to the modules. All respondents rated the videos as very helpful, with a rating of 4 of 5 on a Likert scale. Online otolaryngology educational modules are an inexpensive way to expand resident learning opportunities. Despite the lack of quantifiable improvement in otolaryngology training examination scores in this study, use of online modules sends a message to otolaryngology residents that their education is a priority; self-study outside the hospital

  7. Verneuil's disease, innate immunity and vitamin D: a pilot study.

    Guillet, A; Brocard, A; Bach Ngohou, K; Graveline, N; Leloup, A-G; Ali, D; Nguyen, J-M; Loirat, M-J; Chevalier, C; Khammari, A; Dreno, B


    Verneuil's disease is a chronic inflammatory skin disease of the follicles in apocrine glands rich area of the skin (axillary, inguinal, anogenital) and is associated with a deficient skin innate immunity. It is characterized by the occurrence of nodules, abscesses, fistulas, scars. Recently, vitamin D has been shown to stimulate skin innate immunity. The primary objective of the study was to assess whether Verneuil's disease was associated with vitamin D deficiency. The secondary objective was to determine whether vitamin D supplementation could improve inflammatory lesions. First, 25(OH) vitamin D3 serum levels in patients with Verneuil's disease followed at Nantes University Hospital were compared to those of healthy donors from the French Blood Bank. Then, a pilot study was conducted in 14 patients supplemented with vitamin D according to their vitamin D level at baseline at months 3 and 6. The endpoints at 6 months were decreased by at least 20% in the number of nodules and in the frequency of flare-ups. Twenty-two patients (100%) had vitamin D deficiency (level vitamin D deficiency (91%) of whom 14% were severely deficient. In 14 patients, the supplementation significantly decreased the number of nodules at 6 months (P = 0.01133), and the endpoints were achieved in 79% of these patients. A correlation between the therapeutic success and the importance of the increase in vitamin D level after supplementation was observed (P = 0.01099). Our study shows that Verneuil's disease is associated with a major vitamin D deficiency, correlated with the disease severity. It suggests that vitamin D could significantly improve the inflammatory nodules, probably by stimulating the skin innate immunity. A larger randomized study is needed to confirm these findings. © 2014 European Academy of Dermatology and Venereology.

  8. Probabilistic assessment of fire related events in CWPH (Pilot study)

    Chatterjee, D.; Maity, S.C.; Guptan, Rajee; Mohan, Nalini; Ghadge, S.G.; Bajaj, S.S.


    As a part of Fire PSA for KAPS, a pilot study has been taken up identifying CWPH as the important zone vulnerable to fire. As the CWPH houses pumps belonging to all important cooling (APWC, FFW, NAHPPW, NALPW, etc.) of both the units, a single fire leads to failure of multiple safety/safety support system cooling affecting the safety of the plant. The objective of this study is as follows: Familiarising with the various published Fire-PSA study, comparing and finalisation of the computer code amongst various codes available with DAE, identifying and sequencing different activities involved for carrying out Fire PSA, i.e. Zoning and Sub-Zoning of Fire Source Area, Fire vulnerability of System and Component surrounding Fire Source, etc., finalization of report format and documentation. Computer Code FDS is used to carry out Fire Hazard Analysis. FDS is the latest state-of the-art software package extensively used for Fire Hazard Analysis. It develops a 3D scenario for any given fire giving credit to actual physical location of fire load and ventilation. It gives the time dependent of any fire in a specific zone crediting the time required by operator to take necessary preventive action which helps in quantifying the probability of error for any particular operator's for PSA study. To identify the most vulnerable sub-zone in CWPH, a walk down was organized and physical location of each load; their separation, fire barrier, ventilator in the room, arrangement of fire protection/fighting system, localized operator's room were reviewed. Fire in the middle diesel tank with pump is considered as initiating event in the sub-zone of CWPH. The Event Tree for this initiating event for CWPH was developed. Event Tree end states are identified as large fire i.e. fire which is failed to be detected by both means, i.e. early and late and failure in fighting by both means i.e. early and late. (author)

  9. Probabilistic Tsunami Hazard Assessment: the Seaside, Oregon Pilot Study

    Gonzalez, F. I.; Geist, E. L.; Synolakis, C.; Titov, V. V.


    A pilot study of Seaside, Oregon is underway, to develop methodologies for probabilistic tsunami hazard assessments that can be incorporated into Flood Insurance Rate Maps (FIRMs) developed by FEMA's National Flood Insurance Program (NFIP). Current NFIP guidelines for tsunami hazard assessment rely on the science, technology and methodologies developed in the 1970s; although generally regarded as groundbreaking and state-of-the-art for its time, this approach is now superseded by modern methods that reflect substantial advances in tsunami research achieved in the last two decades. In particular, post-1990 technical advances include: improvements in tsunami source specification; improved tsunami inundation models; better computational grids by virtue of improved bathymetric and topographic databases; a larger database of long-term paleoseismic and paleotsunami records and short-term, historical earthquake and tsunami records that can be exploited to develop improved probabilistic methodologies; better understanding of earthquake recurrence and probability models. The NOAA-led U.S. National Tsunami Hazard Mitigation Program (NTHMP), in partnership with FEMA, USGS, NSF and Emergency Management and Geotechnical agencies of the five Pacific States, incorporates these advances into site-specific tsunami hazard assessments for coastal communities in Alaska, California, Hawaii, Oregon and Washington. NTHMP hazard assessment efforts currently focus on developing deterministic, "credible worst-case" scenarios that provide valuable guidance for hazard mitigation and emergency management. The NFIP focus, on the other hand, is on actuarial needs that require probabilistic hazard assessments such as those that characterize 100- and 500-year flooding events. There are clearly overlaps in NFIP and NTHMP objectives. NTHMP worst-case scenario assessments that include an estimated probability of occurrence could benefit the NFIP; NFIP probabilistic assessments of 100- and 500-yr

  10. Study of the CMS Phase 1 Pixel Pilot Blade Reconstruction

    CMS Collaboration


    The silicon pixel detector is the innermost component of the CMS tracking system. It was replaced in March 2017 with an upgraded one, called the Phase 1 upgrade detector. During Long Shutdown 1, a third disk was inserted into the present forward pixel detector with eight prototype blades constructed using a new digital read-out chip architecture and a prototype readout chain. Testing the performance of these pilot modules enabled us to gain experience with the Phase 1 upgrade modules. In this document, the data reconstruction with the pilot system is presented. The hit finding efficiency and residual of these new modules is also shown, and how these observables were used to adjust the timing of the pilot blades.

  11. Ziprasidone versus olanzapine, risperidone or quetiapine in patients with chronic schizophrenia: a 12-week open-label, multicentre clinical trial

    Lublin, Henrik; Haug, Hans-Joachim; Koponen, Hannu


    The efficacy, safety and tolerability of ziprasidone versus the comparators olanzapine, risperidone or quetiapine were investigated in adult patients with chronic schizophrenia, schizoaffective and schizophreniform disorders, with lack of efficacy or intolerance to their previous antipsychotic tr...

  12. Reversal of olanzapine-induced weight gain in a patient with schizophrenia by switching to asenapine: a case report

    Okazaki K


    Full Text Available Kosuke Okazaki, Kazuhiko Yamamuro, Toshifumi Kishimoto Department of Psychiatry, Nara Medical University School of Medicine, Kashihara, Japan Aims: Antipsychotics are effective for treating schizophrenia, but atypical antipsychotics can cause several adverse side effects including weight gain, hyperprolactinemia, and extrapyramidal symptoms. Moreover, weight gain increases the risk of metabolic diseases.Methods: We treated a case of olanzapine-induced weight gain in a 41-year-old man with schizophrenia by switching his medication from olanzapine to asenapine.Results: The weight gain improved after switching the medication, from 80.3 to 75.0 kg, a weight loss of 6.6%, and there was no significant worsening of psychological symptoms or other adverse effects.Conclusions: Asenapine might be effective for treating patients with schizophrenia who experience olanzapine-induced weight gain. Keywords: olanzapine, weight gain, schizophrenia, asenapine

  13. Predictors and correlates for weight changes in patients co-treated with olanzapine and weight mitigating agents; a post-hoc analysis

    Heinloth Alexandra N


    Full Text Available Abstract Background This study focuses on exploring the relationship between changes in appetite or eating behaviors and subsequent weight change for adult patients with schizophrenia or bipolar disorder treated with olanzapine and adjunctive potential weight mitigating pharmacotherapy. The aim is not to compare different weight mitigating agents, but to evaluate patients' characteristics and changes in their eating behaviors during treatment. Identification of patient subgroups with different degrees of susceptibility to the effect of weight mitigating agents during olanzapine treatment may aid clinicians in treatment decisions. Methods Data were obtained from 3 randomized, double-blind, placebo-controlled, 16-week clinical trials. Included were 158 patients with schizophrenia or bipolar disorder and a body mass index (BMI ≥ 25 kg/m2 who had received olanzapine treatment in combination with nizatidine (n = 68, sibutramine (n = 42, or amantadine (n = 48. Individual patients were analyzed for categorical weight loss ≥ 2 kg and weight gain ≥ 1 kg. Variables that were evaluated as potential predictors of weight outcomes included baseline patient characteristics, factors of the Eating Inventory, individual items of the Eating Behavior Assessment, and the Visual Analog Scale. Results Predictors/correlates of weight loss ≥ 2 kg included: high baseline BMI, low baseline interest in food, and a decrease from baseline to endpoint in appetite, hunger, or cravings for carbohydrates. Reduced cognitive restraint, increase in hunger, and increased overeating were associated with a higher probability of weight gain ≥ 1 kg. Conclusion The association between weight gain and lack of cognitive restraint in the presence of increased appetite suggests potential benefit of psychoeducational counseling in conjunction with adjunctive pharmacotherapeutic agents in limiting weight gain during antipsychotic drug therapy. Trial Registration This analysis was not

  14. Predictors and correlates for weight changes in patients co-treated with olanzapine and weight mitigating agents; a post-hoc analysis.

    Stauffer, Virginia L; Lipkovich, Ilya; Hoffmann, Vicki Poole; Heinloth, Alexandra N; McGregor, H Scott; Kinon, Bruce J


    This study focuses on exploring the relationship between changes in appetite or eating behaviors and subsequent weight change for adult patients with schizophrenia or bipolar disorder treated with olanzapine and adjunctive potential weight mitigating pharmacotherapy. The aim is not to compare different weight mitigating agents, but to evaluate patients' characteristics and changes in their eating behaviors during treatment. Identification of patient subgroups with different degrees of susceptibility to the effect of weight mitigating agents during olanzapine treatment may aid clinicians in treatment decisions. Data were obtained from 3 randomized, double-blind, placebo-controlled, 16-week clinical trials. Included were 158 patients with schizophrenia or bipolar disorder and a body mass index (BMI) > or = 25 kg/m2 who had received olanzapine treatment in combination with nizatidine (n = 68), sibutramine (n = 42), or amantadine (n = 48). Individual patients were analyzed for categorical weight loss > or= 2 kg and weight gain > or = 1 kg. Variables that were evaluated as potential predictors of weight outcomes included baseline patient characteristics, factors of the Eating Inventory, individual items of the Eating Behavior Assessment, and the Visual Analog Scale. Predictors/correlates of weight loss > or = 2 kg included: high baseline BMI, low baseline interest in food, and a decrease from baseline to endpoint in appetite, hunger, or cravings for carbohydrates. Reduced cognitive restraint, increase in hunger, and increased overeating were associated with a higher probability of weight gain > or = 1 kg. The association between weight gain and lack of cognitive restraint in the presence of increased appetite suggests potential benefit of psychoeducational counseling in conjunction with adjunctive pharmacotherapeutic agents in limiting weight gain during antipsychotic drug therapy. This analysis was not a clinical trial and did not involve any medical intervention.

  15. Treatment of Hallux Valgus with Hyaluronic Acid: A Pilot Study

    Ižlhan Sezer


    Full Text Available Aim: Hallux valgus is the deformity of the first metatarsophalangeal (MTP joint with abduction and valgus rotation of the great toe, combined with a medially prominent first metatarsal head. Hyaluronic acid injection has been used in the treatment of degenerative disorders of several joints successfully. In this research, we aimed to investigate the effectiveness of hyaluronic acid injection in patients with hallux valgus. Material and Method: Eleven female and two male patients with hallux valgus were included in this pilot study. Only patients with mild and moderate hallux valgus were included in the study. 1 cc hyaluronic acid was injected into the affected MTF joint three times, at one-week intervals. Visual analogue scale(VAS score, walking time without pain, walking distance, and daily analgesic needs of the patients were recorded. All clinical outcomes were assessed before, and then one and three months after the first injection. Results:The mean VAS score was 83.08±4.58. One month after the first injection, VAS scores of patients had decreased significantly (30±4.38, P: 0.001. Also, increased walking time and distance and decreased daily analgesic need were observed at the first month of postinjection follow-up (P: 0.001. After 3 months, the positive outcomes remained significant compared to preinjection evaluations. Discussion: According to our preliminary results, we suggest thathyaluronic acid injectionsmay be effective in reducing pain and increasing walking time and distance in patients with hallux valgus.Future studies are needed to clarify the beneficial effects of hyaluronic acid injection in patients with hallux valgus.

  16. Pilot Evaluation Study of the Life Skills Program REBOUND

    Henrik Jungaberle


    Full Text Available The main aim of the study is pilot evaluation of the life skills program REBOUND in a school context focusing on substance use, risk perception, and knowledge about psychoactive substances ( n IG + CG = 723 students in five schools and 46 classes, Mage = 14.8, range 14-18 for the total sample and in the subgroups gender, age, and school type. Main goal of the study is collecting evidence for program optimization. A controlled study was carried out with repeated measurement before and after the intervention (4-6 months. Multilevel analyses, ANCOVA, and logistic regression analyses were applied to measure the effects. Overall, significantly lower incidence rates of drunkenness (odds ratio [OR] = .55; p = .033, improved knowledge about psychoactive substances (p = .006, lower personal (p = .013 and general tobacco risk perception among users (p = .002, and lower general tobacco (p = .018 and cannabis (p = .000 risk perception in non-users were found in the total intervention group. In subgroups, significantly lower rates for the incidence of drunkenness can be shown for males (p = .008 and for younger participants (p = .004. Students at academic high school (German Gymnasium showed a decrease in 30-day prevalence for alcohol (p = .017 and cannabis (p = .014, and they improved in their knowledge about psychoactive substances (p = .000. In vocational high school classes (German Realschule, there was an increase in the relative alcohol risk perception of the students (p = .019. REBOUND contributes to a controlled use of alcohol and increases knowledge about psychoactive substances. REBOUND has various effects on the examined subgroups age, gender, and school type: Males, younger students, and students in academic high school benefitted more from the course regarding consumption-related criteria. We suggest a program optimization specific to school form and age, inclusion of a tobacco intervention, and the use of more gender-segregated interventions.

  17. Aspirating and Nonaspirating Swallow Sounds in Children: A Pilot Study.

    Frakking, Thuy; Chang, Anne; O'Grady, Kerry; David, Michael; Weir, Kelly


    Cervical auscultation (CA) may be used to complement feeding/swallowing evaluations when assessing for aspiration. There are no published pediatric studies that compare the properties of sounds between aspirating and nonaspirating swallows. To establish acoustic and perceptual profiles of aspirating and nonaspirating swallow sounds and determine if a difference exists between these 2 swallowing types. Aspiration sound clips were obtained from recordings using CA simultaneously undertaken with videofluoroscopic swallow study. Aspiration was determined using the Penetration-Aspiration Scale. The presence of perceptual swallow/breath parameters was rated by 2 speech pathologists who were blinded to the type of swallow. Acoustic data between groups were compared using Mann Whitney U-tests, while perceptual differences were determined by a test of 2 proportions. Combinations of perceptual parameters of 50 swallows (27 aspiration, 23 no aspiration) from 47 children (57% male) were statistically analyzed using area under a receiver operating characteristic (aROC), sensitivity, specificity, and positive and negative predictive values to determine predictors of aspirating swallows. The combination of post-swallow presence of wet breathing and wheeze and absence of GRS and normal breathing was the best predictor of aspiration (aROC = 0.82, 95% CI, 0.70-0.94). There were no significant differences between these 2 swallow types for peak frequency, duration, and peak amplitude. Our pilot study has shown that certain characteristics of swallow obtained using CA may be useful in the prediction of aspiration. However, further research comparing the acoustic swallowing sound profiles of normal children to children with dysphagia (who are aspirating) on a larger scale is required. © The Author(s) 2016.

  18. Diet and polycystic kidney disease: A pilot intervention study.

    Taylor, Jacob M; Hamilton-Reeves, Jill M; Sullivan, Debra K; Gibson, Cheryl A; Creed, Catherine; Carlson, Susan E; Wesson, Donald E; Grantham, Jared J


    Dietary sodium, protein, acid precursors, and water have been linked to cyst growth in polycystic kidney disease; yet, no studies in patients have examined the feasibility of using a dietary intervention that controls all of these factors. The aim of this study was to determine if a diet, appropriate for persons of most ages, reduces the excretion of sodium, urea, acid, and decreases mean urine osmolality while gaining acceptance by patients with autosomal dominant polycystic kidney disease (ADPKD). Twelve adults with ADPKD enrolled in a pre-post pilot feasibility study and served as their own controls. Individuals consumed their usual diet for one week then for four weeks followed an isocaloric diet lower in sodium and protein and higher in fruits, vegetables, and water. Three-day diet records and two 24-h urine samples were collected at baseline, week 2, and week 4 visits; blood pressure, weight, and serum were obtained at all three visits. A modified nutrition hassles questionnaire was completed on the last visit. During the dietary intervention, subjects (n = 11) consumed less sodium, protein, and dietary acid precursors 36%, 28%, and 99%, respectively, and increased fluid intake by 42%. Urinary sodium, urea, net acid excretion, osmoles, and osmolality decreased 20%, 28%, 20%, 37%, and 15%, respectively; volume increased 35%. Urine changes were in accord with the diet record. Ninety-one percent of participants reported that none of the hassles were worse than "somewhat severe", and most participants felt "somewhat confident" or "very confident" that they could manage the new diet. A majority of adult patients with ADPKD successfully prepared and followed a composite diet prescription with decreased sodium, protein, acid precursors, and increased fluid intake. This trail was registered at (NCT01810614). Copyright © 2016 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  19. A pilot study examining density of suppression measurement in strabismus.

    Piano, Marianne; Newsham, David


    Establish whether the Sbisa bar, Bagolini filter (BF) bar, and neutral density filter (NDF) bar, used to measure density of suppression, are equivalent and possess test-retest reliability. Determine whether density of suppression is altered when measurement equipment/testing conditions are changed. Our pilot study had 10 subjects aged ≥18 years with childhood-onset strabismus, no ocular pathologies, and no binocular vision when manifest. Density of suppression upon repeated testing, with clinic lights on/off, and using a full/reduced intensity light source, was investigated. Results were analysed for test-retest reliability, equivalence, and changes with alteration of testing conditions. Test-retest reliability issues were present for the BF bar (median 6 filter change from first to final test, p = 0.021) and NDF bar (median 5 filter change from first to final test, p = 0.002). Density of suppression was unaffected by environmental illumination or fixation light intensity variations. Density of suppression measurements were higher when measured with the NDF bar (e.g. NDF bar = 1.5, medium suppression, vs BF bar = 6.5, light suppression). Test-retest reliability issues may be present for the two filter bars currently still under manufacture. Changes in testing conditions do not significantly affect test results, provided the same filter bar is used consistently for testing. Further studies in children with strabismus having active amblyopia treatment would be of benefit. Despite extensive use of these tests in the UK, this is to our knowledge the first study evaluating filter bar equivalence/reliability.

  20. Introducing Namaste Care to the hospital environment: a pilot study.

    St John, Kimberley; Koffman, Jonathan


    The rising prevalence of dementia is impacting on acute hospitals and placing increased expectations on health and social care professionals to improve the support and services they are delivering. It has been recommended that good practice in dementia care relies on adopting a palliative approach to care and meeting people's physical, psychological, social and spiritual needs. Increased dementia training for staff that includes initiatives that promote dignity; enhancing communication skills and recognizing that a person with dementia may be approaching the end of their lives are needed. Our study aim was to explore whether Namaste Care is an acceptable and effective service for people with advanced dementia being cared for on an acute hospital ward. This was an exploratory qualitative interview, pilot study. Individual, semi-structured, face-to-face interviews were conducted with hospital healthcare staff working in an area of the hospital where Namaste Care had been implemented. Data were analysed using the framework approach. Eight interviews were completed with members of the multidisciplinary ward team. Two themes were identified: (I) difficulties establishing relationships with people with dementia in hospital (subthemes: lack of time and resources, lack of confidence leading to fear and anxiety); (II) the benefits of a Namaste Care service in an acute hospital setting (subthemes: a reduction in agitated behavior; connecting and communicating with patients with dementia using the senses; a way of showing people with dementia they are cared for and valued). This small-scale study indicates that Namaste Case has the potential to improve the quality of life of people with advanced dementia being cared for in an acute hospital setting. However, further research is required to explore more specifically its benefits in terms of improved symptom management and wellbeing of people with dementia on acute hospitals wards.

  1. Managing ethical issues in sexual violence research using a pilot study

    S.E. Duma


    Full Text Available Conducting research in the area of sexual violence has complex ethical and practical challenges for the researcher. Managing ethical issues in sexual violence is important and can be achieved through the use of pilot studies. The primary purpose of the pilot study was to identify and manage potential ethical and practical problems that could jeopardise the main study or violate the ethical and human rights of participants in the main study on women’s journey of recovery from sexual assault. The secondary purpose was to collect preliminary data in order to determine the human, financial and time resources needed for a planned study. The methods and processes used in conducting the pilot study in the study on women’s journey of recovery are discussed according to each of the objectives of the pilot study, methods used to achieve the objective, observations or findings made during the pilot study, and implications for the main study. This article aims to demonstrate how a pilot study was used to manage identified potential ethical and practical research issues during the recruitment of participants and data collection for the research that was conducted by the first author to investigate women’s journey of recovery from sexual assault trauma within the first week following sexual assault.

  2. What is a pilot or feasibility study? A review of current practice and editorial policy

    Cooper Cindy L; Campbell Michael J; Arain Mubashir; Lancaster Gillian A


    Abstract Background In 2004, a review of pilot studies published in seven major medical journals during 2000-01 recommended that the statistical analysis of such studies should be either mainly descriptive or focus on sample size estimation, while results from hypothesis testing must be interpreted with caution. We revisited these journals to see whether the subsequent recommendations have changed the practice of reporting pilot studies. We also conducted a survey to identify the methodologic...

  3. Negative effects of chronic oral chlorpromazine and olanzapine treatment on the performance of tasks designed to assess spatial learning and working memory in rats.

    Terry, A V; Warner, S E; Vandenhuerk, L; Pillai, A; Mahadik, S P; Zhang, G; Bartlett, M G


    Learning potential and memory capacity are factors that strongly predict the level of rehabilitation and the long-term functional outcome in patients with schizophrenia. Unfortunately, however, the effects of antipsychotic drugs (i.e. the primary treatments for schizophrenia) on these components of cognition are unclear, particularly when they are administered chronically (i.e. a standard clinical practice). In this rodent study we evaluated the effects of different time periods (ranging from 2 weeks to 6 months) of oral treatment with the first generation antipsychotic chlorpromazine (10.0 mg/kg/day), or the second generation antipsychotic olanzapine (10.0 mg/kg/day) on the repeated acquisition of a water maze task (i.e. a method of assessing spatial learning potential in a repeated testing format). We assessed locomotor function (in an open field) and employed a radial arm maze (RAM) task to assess antipsychotic effects (5.0 and 10.0 mg/kg/day doses) on spatial working memory during the treatment period between 15 days and 2 months. Finally, we conducted experiments using liquid chromatography/tandem mass spectrometry (LC-MS/MS) to evaluate the therapeutic relevance of our method of drug delivery (oral administration in drinking water). In the water maze experiments, both antipsychotics were associated with impairments in acquisition in the earlier test sessions that could eventually be overcome with repeated testing while olanzapine also impaired retention in probe trials. Both antipsychotics were also associated with impairments in delayed non-match-to-position trials in the RAM and some impairments of motor function (especially in the case of olanzapine) as indicated by slightly reduced swim speeds in the water maze and decreased activity in some components of the open field assessment. Finally, LC-MS/MS studies indicated that the method of antipsychotic administration generated clinically relevant plasma levels in the rat. These animal data indicate that

  4. Endometrial Histology of Depomedroxyprogesterone Acetate Users: A Pilot Study


    Full Text Available Objective. To obtain pilot data on the endometrial histology of Depomedroxyprogesterone acetate (Depo-Provera, DMPA users experiencing breakthrough bleeding (BTB versus users with amenorrhea. To compare the endometrial histology of patients who used DMPA continuously for 3–12 months versus those who used it for 13 months or more. Methods. Cross-sectional study. Endometrial biopsy was obtained from all consenting patients who used DMPA for at least 3 months. Patients were divided into those with BTB in the last 3 months versus those with amenorrhea for at least 3 months. Histology results and duration of therapy were compared. Results. The proportion of women with chronic endometritis, uterine polyps, atrophic, proliferative, or progesterone-dominant endometrium did not differ between those DMPA users with BTB versus those with amenorrhea. Duration of therapy did not correlate with symptoms of BTB or endometrial histology. Chronic endometritis was the most common histologic finding (10/40, 25% and occurred more often in women experiencing BTB (35% versus 15% (RR 1.62 CI 0.91–2.87. Moreover, 45% of women with BTB had received DMPA for more than 12 months. Conclusions. BTB was more common than previously reported in women using DMPA for more than 12 months. Chronic endometritis, which may indicate an underlying infectious or intracavitary anatomic etiology, has not been previously reported as a frequent finding in DMPA users, and may be related to ethnic or other sociodemographic characteristics of our patient population. Further study to elucidate the etiology of chronic endometritis in these patients is warranted.

  5. Retinoid Expression in Onchocercal Skin Disease: Pilot Study.

    Mawson, Anthony R; Makunde, Williams H; Penman, Alan D; Hernandez Morales, Veronica de Los Angeles; Kalinga, Akili K; Francis, Filbert; Rubinchik, Semyon; Kibweja, Addow


    Based on the observation that the parasite Onchocerca volvulus selectively absorbs vitamin A from the host, and the known toxicity of vitamin A in higher concentration, it was hypothesized that dying microfilariae (mf) release their stores of vitamin A (retinoids) into the host circulation in toxic concentrations, inducing the signs and symptoms of onchocerciasis. We conducted a pilot study to test the hypothesis in Songea communities in Southern Tanzania, where mass drug administration with ivermectin had not been implemented by the time of the survey. The specific aim was to evaluate the correlation between the diagnosis of onchocerciasis and increased levels of retinoic acid at infection sites. The analysis was performed by determining copy numbers of a genome of O volvulus present in skin snip samples of persons with onchocerciacis, and correlating these numbers with expression levels of retinoic acid receptor-α (RAR-α), which is inducible by retinoic acid. Total DNA and RNA were extracted from each of 25 mf-positive and 25 mf-negative skin samples and evaluated using quantitative polymerase chain reaction with appropriate negative controls. Analysis of the samples, adjusted with glyceraldehyde 3-phosphate dehydrogenase gene levels, revealed that most samples with detectable RAR-α transcripts had higher levels of RAR-α expression than the assay control. However, the quality and number of samples were insufficient for statistical analysis. Fold data on the expression levels of both O volvulus DNA and RAR RNA suggested a possible trend toward higher relative RAR-α expression in samples with higher levels of O volvulus DNA ( r 2  = 0.25, P  = .079). Evidence of a contribution of vitamin A to the pathology of onchocerciasis thus remains elusive. Future studies on the role of retinoids in onchocerciasis will require larger groups of participants as well as careful monitoring of the cold chain and tissue storage procedures in view of the sensitivity of

  6. Rare variants in ischemic stroke: an exome pilot study.

    John W Cole

    Full Text Available The genetic architecture of ischemic stroke is complex and is likely to include rare or low frequency variants with high penetrance and large effect sizes. Such variants are likely to provide important insights into disease pathogenesis compared to common variants with small effect sizes. Because a significant portion of human functional variation may derive from the protein-coding portion of genes we undertook a pilot study to identify variation across the human exome (i.e., the coding exons across the entire human genome in 10 ischemic stroke cases. Our efforts focused on evaluating the feasibility and identifying the difficulties in this type of research as it applies to ischemic stroke. The cases included 8 African-Americans and 2 Caucasians selected on the basis of similar stroke subtypes and by implementing a case selection algorithm that emphasized the genetic contribution of stroke risk. Following construction of paired-end sequencing libraries, all predicted human exons in each sample were captured and sequenced. Sequencing generated an average of 25.5 million read pairs (75 bp×2 and 3.8 Gbp per sample. After passing quality filters, screening the exomes against dbSNP demonstrated an average of 2839 novel SNPs among African-Americans and 1105 among Caucasians. In an aggregate analysis, 48 genes were identified to have at least one rare variant across all stroke cases. One gene, CSN3, identified by screening our prior GWAS results in conjunction with our exome results, was found to contain an interesting coding polymorphism as well as containing excess rare variation as compared with the other genes evaluated. In conclusion, while rare coding variants may predispose to the risk of ischemic stroke, this fact has yet to be definitively proven. Our study demonstrates the complexities of such research and highlights that while exome data can be obtained, the optimal analytical methods have yet to be determined.

  7. Leading teams during simulated pediatric emergencies: a pilot study

    Coolen EH


    Full Text Available Ester H Coolen,1 Jos M Draaisma,2 Sabien den Hamer,3 Jan L Loeffen2 1Department of Pediatric Surgery, Amalia Children’s Hospital, Radboud University Medical Center, 2Department of Pediatrics, Amalia Children’s Hospital, Radboud University Medical Center, 3Department of Communication Science, Radboud University, Nijmegen, the Netherlands Purpose: Leadership has been identified as a key variable for the functioning of teams and as one of the main reasons for success or failure of team-based work systems. Pediatricians often function as team leaders in the resuscitation of a critically ill child. However, pediatric residents often report having little opportunity to perform in the role of team leader during residency. In order to gain more insight into leadership skills and behaviors, we classified leadership styles of pediatric residents during simulated emergencies. Methods: We conducted a prospective quantitative study to investigate leadership styles used by pediatric residents during simulated emergencies with clinical deterioration of a child at a pediatric ward. Using videotaped scenarios of 48 simulated critical events among 12 residents, we were able to classify verbal and nonverbal communication into different leadership styles according to the situational leadership theory. Results: The coaching style (mean 54.5%, SD 7.8 is the most frequently applied by residents, followed by the directing style (mean 35.6%, SD 4.1. This pattern conforms to the task- and role-related requirements in our scenarios and it also conforms to the concept of situational leadership. We did not find any significant differences in leadership style according to the postgraduate year or scenario content. Conclusion: The model used in this pilot study helps us to gain a better understanding of the development of effective leadership behavior and supports the applicability of situational leadership theory in training leadership skills during residency. Keywords

  8. Prioritization strategies in clinical practice guidelines development: a pilot study

    Torres Marcela


    Full Text Available Abstract Objective Few methodological studies address the prioritization of clinical topics for the development of Clinical Practice Guidelines (CPGs. The aim of this study was to validate a methodology for Priority Determination of Topics (PDT of CPGs. Methods and results Firstly, we developed an instrument for PDT with 41 criteria that were grouped under 10 domains, based on a comprehensive systematic search. Secondly, we performed a survey of stakeholders involved in CPGs development, and end users of guidelines, using the instrument. Thirdly, a pilot testing of the PDT procedure was performed in order to choose 10 guideline topics among 34 proposed projects; using a multi-criteria analysis approach, we validated a mechanism that followed five stages: determination of the composition of groups, item/domain scoring, weights determination, quality of the information used to support judgments, and finally, topic selection. Participants first scored the importance of each domain, after which four different weighting procedures were calculated (including the survey results. The process of weighting was determined by correlating the data between them. We also reported the quality of evidence used for PDT. Finally, we provided a qualitative analysis of the process. The main domains used to support judgement, having higher quality scores and weightings, were feasibility, disease burden, implementation and information needs. Other important domains such as user preferences, adverse events, potential for health promotion, social effects, and economic impact had lower relevance for clinicians. Criteria for prioritization were mainly judged through professional experience, while good quality information was only used in 15% of cases. Conclusion The main advantages of the proposed methodology are supported by the use of a systematic approach to identify, score and weight guideline topics selection, limiting or exposing the influence of personal biases

  9. Effect of Piroxicam on ART Outcome: A Pilot Study

    Farnaz Sohrabvand


    Full Text Available Background: One of the most important factors affecting success rates in assisted reproductive techniques (ART besides the number of oocytes retrieved and high quality embryos derived from them is the technical aspects of embryo transfer. It seems that pretreatement with uterine relaxants can be helpful in preventing unpleasant cramps which can have an adverse effect on ART outcome. In this respect, some drugs such as prostaglandin inhibitors or sedatives have been evaluated but not confirmed yet remain controversial. This study was performed in order to assess the effect of administrating Piroxicam prior to embryo transfer on pregnancy rates in ART cycles. Materials and Methods: This pilot study was performed from August 2010 through December 2011 on 50 infertile women in ART cycles. Recombinant follicle stimulating hormone (rFSH with a long gonadotropin releasing hormone (GnRH analogue protocol were used for controlled ovarian hyperstimulation. The subjects were randomly allocated into two groups of 25 patients after obtaining written consent. Group A received a 10 mg Piroxicam capsule 30 minutes before embryo transfer and group B was the control group with no treatment. Data were analyzed by Chi-square and analysis of variance (ANOVA. Results: Pregnancy rate was 34% (n=17 totally, with 32% (n=8 in group A and 36% (n=9 in group B (p=0.75. Uterine cramps were experienced by 4 women (16% in group B, while none were reported by women in group A (p=0.037. Conclusion: It seems that Piroxicam administration 30 minutes prior to embryo transfer cannot increase pregnancy rates, but can prevent or reduce uterine cramps after the procedure.

  10. Feasibility of the Dutch ICF Activity Inventory: a pilot study

    van Nispen Ruth MA


    Full Text Available Abstract Background Demographic ageing will lead to increasing pressure on visual rehabilitation services, which need to be efficiently organised in the near future. The Dutch ICF Activity Inventory (D-AI was developed to assess the rehabilitation needs of visually impaired persons. This pilot study tests the feasibility of the D-AI using a computer-assisted telephone interview. Methods In addition to the regular intake, the first version of the D-AI was assessed in 20 patients. Subsequently, patients and intake assessors were asked to fill in an evaluation form. Based on these evaluations, a new version of the D-AI was developed. Results Mean administration time of the D-AI was 88.8 (± 41.0 minutes. Overall, patients and assessors were positive about the D-AI assessment. However, professionals and 60% of the patients found the administration time to be too long. All included items were considered relevant and only minor adjustments were recommended. Conclusion The systematic character of the revised D-AI will prevent topics from being overlooked and indicate which needs have the highest priority from a patient-centred perspective. Moreover, ongoing assessment of the D-AI will enhance evaluation of the rehabilitation process. To decrease administration time, in the revised D-AI only the top priority goals will be fully assessed. Using the D-AI, a rehabilitation plan based on individual needs can be developed for each patient. Moreover, it enables better evaluation of the effects of rehabilitation. A larger validation study is planned.

  11. Handwriting difficulties in juvenile idiopathic arthritis: a pilot study.

    Haberfehlner, Helga; Visser, Bart; Daffertshofer, Andreas; van Rossum, Marion Aj; Roorda, Leo D; van der Leeden, Marike; Dekker, Joost; Hoeksma, Agnes F


    The aim of the present study was to describe handwriting difficulties of primary school children with juvenile idiopathic arthritis (JIA), and to investigate possible correlations with hand function and writing performance. In a cross-sectional approach, 15 children with JIA and reported handwriting difficulties were included together with 15 healthy matched controls. Impairments (signs of arthritis or tenosynovitis, reduced grip force and limited range of motion of the wrist (wrist-ROM)), activity limitations (reduced quality and speed of handwriting, pain during handwriting), and participation restrictions (perceived handwriting difficulties at school) were assessed and analysed. Although selected by the presence of handwriting difficulties, the majority of the JIA children (73%) had no active arthritis of the writing hand, and only minor hand impairments were found. Overall, the JIA children performed well during the short handwriting test, but the number of letters they wrote per minute decreased significantly during the 5-minute test, compared to the healthy controls. JIA patients had significantly higher pain scores on a 100 mm Visual Analogue Scale, compared to the healthy controls. The actual presence of arthritis, and limitation in grip force and wrist-ROM did not correlate with reported participation restrictions with regard to handwriting at school. The JIA children reported pain during handwriting, and inability to sustain handwriting for a longer period of time. The results of this pilot study show that JIA children with handwriting difficulties, experience their restrictions mainly through pain and the inability to sustain handwriting for a longer period of time. No correlations could be found with impairments.

  12. Doping control container for urine stabilization: a pilot study.

    Tsivou, Maria; Giannadaki, Evangelia; Hooghe, Fiona; Roels, Kris; Van Gansbeke, Wim; Garribba, Flaminia; Lyris, Emmanouil; Deventer, Koen; Mazzarino, Monica; Donati, Francesco; Georgakopoulos, Dimitrios G; Van Eenoo, Peter; Georgakopoulos, Costas G; de la Torre, Xavier; Botrè, Francesco


    Urine collection containers used in the doping control collection procedure do not provide a protective environment for urine, against degradation by microorganisms and proteolytic enzymes. An in-house chemical stabilization mixture was developed to tackle urine degradation problems encountered in human sport samples, in cases of microbial contamination or proteolytic activity. The mixture consists of antimicrobial substances and protease inhibitors for the simultaneous inactivation of a wide range of proteolytic enzymes. It has already been tested in lab-scale, as part of World Anti-Doping Agency's (WADA) funded research project, in terms of efficiency against microbial and proteolytic activity. The present work, funded also by WADA, is a follow-up study on the improvement of chemical stabilization mixture composition, application mode and limitation of interferences, using pilot urine collection containers, spray-coated in their internal surface with the chemical stabilization mixture. Urine in plastic stabilized collection containers have been gone through various incubation cycles to test for stabilization efficiency and analytical matrix interferences by three WADA accredited Laboratories (Athens, Ghent, and Rome). The spray-coated chemical stabilization mixture was tested against microorganism elimination and steroid glucuronide degradation, as well as enzymatic breakdown of proteins, such as intact hCG, recombinant erythropoietin and small peptides (GHRPs, ipamorelin), induced by proteolytic enzymes. Potential analytical interferences, observed in the presence of spray-coated chemical stabilization mixture, were recorded using routine screening procedures. The results of the current study support the application of the spray-coated plastic urine container, in the doping control collection procedure. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  13. Pilot Feasibility Study of an Oncology Financial Navigation Program.

    Shankaran, Veena; Leahy, Tony; Steelquist, Jordan; Watabayashi, Kate; Linden, Hannah; Ramsey, Scott; Schwartz, Naomi; Kreizenbeck, Karma; Nelson, Judy; Balch, Alan; Singleton, Erin; Gallagher, Kathleen; Overstreet, Karen


    Few studies have reported on interventions to alleviate financial toxicity in patients with cancer. We developed a financial navigation program in collaboration with our partners, Consumer Education and Training Services (CENTS) and Patient Advocate Foundation (PAF), to improve patient knowledge about treatment costs, provide financial counseling, and to help manage out-of-pocket expenses. We conducted a pilot study to assess the feasibility and impact of this program. Patients with cancer received a financial education course followed by monthly contact with a CENTS financial counselor and a PAF case manager for 6 months. We measured program adherence, self-reported financial burden and anxiety, program satisfaction, and type of assistance provided. Thirty-four patients (median age, 60.5 years) were consented (85% white and 50% commercially insured). Debt, income declines, and loans were reported by 55%, 55%, and 30% of patients, respectively. CENTS counselors assisted most often with budgeting, retirement planning, and medical bill questions. PAF case managers assisted with applications for appropriate insurance coverage, cost of living issues (eg, housing, transportation), and disability applications. High financial burden and anxiety about costs (4 or 5 on a Likert scale) were reported at baseline by 37% and 47% of patients, respectively. Anxiety about costs decreased over time in 33% of patients, whereas self-reported financial burden did not substantially change. Implementing an oncology financial navigation program is feasible, provides concrete assistance in navigating the cost of care, and mitigates anxiety about costs in a subset of patients. Future work will focus on measuring the program's impact on financial and clinical outcomes.

  14. Development and Pilot Testing of Daily Interactive Voice Response (IVR) Calls to Support Antiretroviral Adherence in India: A Mixed-Methods Pilot Study.

    Swendeman, Dallas; Jana, Smarajit; Ray, Protim; Mindry, Deborah; Das, Madhushree; Bhakta, Bhumi


    This two-phase pilot study aimed to design, pilot, and refine an automated interactive voice response (IVR) intervention to support antiretroviral adherence for people living with HIV (PLH), in Kolkata, India. Mixed-methods formative research included a community advisory board for IVR message development, 1-month pre-post pilot, post-pilot focus groups, and further message development. Two IVR calls are made daily, timed to patients' dosing schedules, with brief messages (pilot results (n = 46, 80 % women, 60 % sex workers) found significant increases in self-reported ART adherence, both within past three days (p = 0.05) and time since missed last dose (p = 0.015). Depression was common. Messaging content and assessment domains were expanded for testing in a randomized trial currently underway.

  15. Analysis of the Air Force ISO 14001 Pilot Study Conducted by DoD

    Harris, Rodney


    The Department of Defense (DoD) conducted an ISO 14001 pilot study with the primary goal of determining how ISO 14001 could help DoD organizations reduce risks, improve compliance with environmental regulations, enhance stewardship...

  16. Practical Implications of Metacognitively Oriented Psychotherapy in Psychosis : Findings From a Pilot Study

    de Jong, Steven; van Donkersgoed, Rozanne J. M.; Aleman, Andre; van der Gaag, Mark; Wunderink, Lex; Arends, Johan; Lysaker, Paul H.; Pijnenborg, Marieke

    In preparation for a multicenter randomized controlled trial, a pilot study was conducted investigating the feasibility and acceptance of a shortened version (12 vs. 40 sessions) of an individual metacognitive psychotherapy (Metacognitive Reflection and Insight Therapy [MERIT]). Twelve participants

  17. Longitudinal Study of the Health Status of U.S. Navy Combat Pilots.


    included such diagnoses as helminthiasis , amoebiasis, avitaminoses, and dermatophytosis. In examining long-term health effects, results of the study of...consisted of ancylostomiasis, other intestinal helminthiasis , intestinal parasitism, and other infective- parasitic disease. These pilots also had higher

  18. Evaluation of potential particulate/colloidal TEP foulants on a pilot scale SWRO desalination study

    Li, Sheng; Sinha, Shahnawaz; Leiknes, TorOve; Amy, Gary L.; Ghaffour, NorEddine


    This pilot study investigated the variation of potential foulants and different fractions of transparent exopolymer particles (TEP), along the treatment scheme under different conditions. The objectives are to provide a comprehensive understanding

  19. a pilot study of the diagnostic accuracy of fine needle aspirate cytol


    Jun 2, 2018 ... Fibroadenoma of the breast in a South African population -a pilot study of the ... Keywords: Fibroadenoma, diagnosis, breast ultrasonography, fine needle ..... breast cancer among Sudanese patients with breast palpa-.

  20. A pilot study into measurements of markers of atherosclerosis in periodontitis

    Leivadaros, E; van der Velden, U; Bizzarro, S; ten Heggeler, JMAG; Gerdes, VEA; Hoek, FJ; Nagy, TOM; Scholma, J; Bakker, SJL; Gans, ROB; ten Cate, H; Loos, BG

    Background: Periodontitis may be a possible risk factor for atherosclerosis. The current pilot study explored arterial wall thickness and other variables associated with atherosclerosis in healthy subjects with and without periodontitis. Methods: Patients with moderate (N = 34) and severe

  1. Research Note-Testing for Gerontological Competencies: A Pilot Study

    Galambos, Colleen; Curl, Angela L.; Woodbury, Karen


    This article reports on the pilot delivery of an evaluation method to gauge student learning of gerontological competencies. Using a pretest and posttest design, data were collected on 46 students over 3 classes. Results indicated significant improvement in how students rated or perceived their competencies skill level between pretest and posttest…

  2. Electroosmotically enhanced sludge dewatering-pilot-plant study

    Smollen, M


    Full Text Available role in determining the ease or difficulty of phase separation. It seems that the inefficiency of dewatering applied to gelatinous and fine-particle sludges can be overcome by mechanical dewatering enhanced by electroosmosis. A prototype pilot-plant...

  3. Family Planning for Inner-City Adolescent Males: Pilot Study.

    Reis, Janet; And Others


    Describes a pilot family planning program in an inner-city pediatric practice. Male adolescents were more likely to accept contraceptives if the provider first raised the topic of birth control to them. Identified a desire for anonymity/confidentiality and embarrassment or discomfort as the key reasons for not seeking contraceptives. Emphasizes…

  4. Neuromuscular training in construction workers: a longitudinal controlled pilot study.

    Faude, Oliver; Donath, Lars; Bopp, Micha; Hofmann, Sara; Erlacher, Daniel; Zahner, Lukas


    Many accidents at construction sites are due to falls. An exercise-based workplace intervention may improve intrinsic fall risk factors. In this pilot study, we aimed at evaluating the effects of neuromuscular exercise on static and functional balance performance as well as on lower limb explosive power in construction workers. Healthy middle-aged construction workers were non-randomly assigned to an intervention [N = 20, age = 40.3 (SD 8.3) years] or a control group [N = 20, age = 41.8 (9.9) years]. The intervention group performed static and dynamic balance and strength exercises (13 weeks, 15 min each day). Before and after the intervention and after an 8-week follow-up, unilateral postural sway, backward balancing (on 3- and 4.5-cm-wide beams) as well as vertical jump height were assessed. We observed a group × time interaction for postural sway (p = 0.002) with a reduction in the intervention group and no relevant change in the control group. Similarly, the number of successful steps while walking backwards on the 3-cm beam increased only in the intervention group (p = 0.047). These effects were likely to most likely practically beneficial from pretest to posttest and to follow-up test for postural sway (+12%, standardized mean difference (SMD) = 0.65 and 17%, SMD = 0.92) and backward balancing on the 3-cm beam (+58%, SMD = 0.59 and 37%, SMD = 0.40). Fifteen minutes of neuromuscular training each day can improve balance performance in construction workers and, thus, may contribute to a decreased fall risk.

  5. Statin use and peripheral sensory perception: a pilot study.

    West, Brenton; Williams, Cylie M; Jilbert, Elise; James, Alicia M; Haines, Terry P


    Peripheral sensory neuropathy is a neurological deficit resulting in decreased detection of sensation through the peripheral nervous system. Peripheral sensory neuropathy is commonly diagnosed with the use of a monofilament and either a tuning fork or neurothesiometer. Statins are a widely used medication and there has been some debate of association with their use and peripheral sensory neuropathy. This pilot study aimed to test the sensory perception of participants with long-term statin use and compare these results to their peers who were not taking statins. Thirty participants were recruited and equally divided into a statin and non-statin group. Healthy participants were screened by their medical and medication history, Australian Type 2 Diabetes Risk assessment, and random blood glucose level. An assessor who was blinded to the participant group conducted sensory assessments using a 10 g monofilament and neurothesiometer. There was no difference in monofilament testing results between the groups. The statin group was less sensate at the styloid process (p = 0.031) and medial malleolus (p = 0.003) than the control group. Results at the hallux were not statistically significant (p = 0.183). This result is suggestive of a potential association between long-term statin use and a decrease in peripheral sensory perception. This may be because of peripheral sensory neuropathy. Limitations such as consideration of participant height, participant numbers, and inability to analyze results against statin groups are reported. As statins are a life-saving medication, careful consideration should be applied to these results and further research be conducted to determine if these results are applicable to larger populations.

  6. Environmental accounts and trade - a Swedish pilot study

    Wadeskog, A.


    Environmental accounts are supposed to register environmental impacts of economic activities performed by residents on a national basis. However, the international division of labour is not explicitly addressed. A small, open, economy like Sweden use resources, and thereby cause emissions, in other countries due to what is imported for intermediate or final use. On the other hand, the things we export to other countries cause emissions in Sweden. This means that there is an environmental balance of trade that is not explicitly addressed in the accounts. There are however possibilities to estimate these effects. Through input-output analysis it is possible to analyse the value added chain of the different goods and service that make up the final demand, i.e. a form of cradle-to-grave analysis. Environmental trade can be estimated in several ways. One method is to assume that emissions follow the pattern of the trade balance and equal out over time, i.e. ignore the problem. Another method is to calculate the effect of differences in volume and composition in exports and imports. In most cases this is done using the domestic input-output tables and emission coefficients, i.e. assuming that all trading partners have identical resource use, technology and economic structure. A pilot study of the environmental trade balance for Sweden, using different aggregated emissions data for our trading partners and the Swedish input-output table, show that the results calculated with these methods will underestimate external emissions considerably for carbon dioxides and sulphur dioxides. However, for nitrogen oxides emission these methods seem to suffice

  7. Ethical values in emergency medical services: A pilot study.

    Bremer, Anders; Herrera, María Jiménez; Axelsson, Christer; Martí, Dolors Burjalés; Sandman, Lars; Casali, Gian Luca


    Ambulance professionals often address conflicts between ethical values. As individuals' values represent basic convictions of what is right or good and motivate behaviour, research is needed to understand their value profiles. To translate and adapt the Managerial Values Profile to Spanish and Swedish, and measure the presence of utilitarianism, moral rights and/or social justice in ambulance professionals' value profiles in Spain and Sweden. The instrument was translated and culturally adapted. A content validity index was calculated. Pilot tests were carried out with 46 participants. This study conforms to the ethical principles for research involving human subjects and adheres to national laws and regulations concerning informed consent and confidentiality. Spanish professionals favoured justice and Swedish professionals' rights in their ambulance organizations. Both countries favoured utilitarianism least. Gender differences across countries showed that males favoured rights. Spanish female professionals favoured justice most strongly of all. Swedes favour rights while Spaniards favour justice. Both contexts scored low on utilitarianism focusing on total population effect, preferring the opposite, individualized approach of the rights and justice perspectives. Organizational investment in a utilitarian perspective might jeopardize ambulance professionals' moral right to make individual assessments based on the needs of the patient at hand. Utilitarianism and a caring ethos appear as stark opposites. However, a caring ethos in its turn might well involve unreasonable demands on the individual carer's professional role. Since both the justice and rights perspectives portrayed in the survey mainly concern relationship to the organization and peers within the organization, this relationship might at worst be given priority over the equal treatment and moral rights of the patient. A balanced view on ethical perspectives is needed to make professionals observant and

  8. Health Care Delivery Meets Hospitality: A Pilot Study in Radiology.

    Steele, Joseph Rodgers; Jones, A Kyle; Clarke, Ryan K; Shoemaker, Stowe


    The patient experience has moved to the forefront of health care-delivery research. The University of Texas MD Anderson Cancer Center Department of Diagnostic Radiology began collaborating in 2011 with the University of Houston Conrad N. Hilton College of Hotel and Restaurant Management, and in 2013 with the University of Nevada, Las Vegas, William F. Harrah College of Hotel Administration, to explore the application of service science to improving the patient experience. A collaborative pilot study was undertaken by these 3 institutions to identify and rank the specific needs and expectations of patients undergoing imaging procedures in the MD Anderson Department of Diagnostic Radiology. We first conducted interviews with patients, providers, and staff to identify factors perceived to affect the patient experience. Next, to confirm these factors and determine their relative importance, we surveyed more than 6,000 patients by e-mail. All factors considered important in the interviews were confirmed as important in the surveys. The surveys showed that the most important factors were acknowledgment of the patient's concerns, being treated with respect, and being treated like a person, not a "number"; these factors were more important than privacy, short waiting times, being able to meet with a radiologist, and being approached by a staff member versus having one's name called out in the waiting room. Our work shows that it is possible to identify and rank factors affecting patient satisfaction using techniques employed by the hospitality industry. Such factors can be used to measure and improve the patient experience. Copyright © 2015 American College of Radiology. Published by Elsevier Inc. All rights reserved.

  9. Interactive value-based curriculum: a pilot study.

    Bowman Peterson, Jill M; Duffy, Briar; Duran, Alisa; Gladding, Sophia P


    Current health care costs are unsustainable, with a large percentage of waste attributed to doctor practices. Medical educators are developing curricula to address value-based care (VBC) in education. There is, however, a paucity of curricula and assessments addressing levels higher than 'knows' at the base of Miller's pyramid of assessment. Our objective was to: (1) teach residents the principles of VBC using active learning strategies; and (2) develop and pilot a tool to assess residents' ability to apply principles of VBC at the higher level of 'knows how' on Miller's pyramid. Residents in medicine, medicine-paediatrics and medicine-dermatology participated in a 5-week VBC morning report curriculum using active learning techniques. Early sessions targeted knowledge and later sessions emphasised the application of VBC principles. Medical educators are developing curricula to address value-based care in education RESULTS: Thirty residents attended at least one session and completed both pre- and post-intervention tests, using a newly developed case-based assessment tool featuring a 'waste score' balanced with 'standard of care'. Residents, on average, reduced their waste score from pre-intervention to post-intervention [mean 8.8 (SD 6.3) versus mean 4.7 (SD 4.6), p = 0.001]. For those who reduced their waste score, most maintained or improved their standard of care. Our results suggest that residents may be able to decrease health care waste, with the majority maintaining or improving their management of care in a case-based assessment after participation in the curriculum. We are working to further incorporate VBC principles into more morning reports, and to develop further interventions and assessments to evaluate our residents at higher levels on Miller's pyramid of assessment. © 2018 John Wiley & Sons Ltd and The Association for the Study of Medical Education.

  10. Development of a Falls Registry: A Pilot Study.

    Berg, Gina M; Carlson, Tara; Fairchild, Joanne; Edwards, Courtney; Sorell, Ryan

    Each year approximately 1 in 4 healthy older adults aged 65+ years and 1 in 2 aged 80+ years living in the community will fall. Fall-related injuries are the leading cause of death and disability and cost the United States approximately $31 billion annually. Currently, no repository of scene data exists that informs prevention programs regarding circumstances that contribute to older adult falls. This was a multicenter (4 sites: Kansas, Maryland, Oregon, and Texas) pilot study consisting of interviews of older (55+ years) patients who had been admitted to a trauma center with fall-related injuries. Questions included information regarding environment, behaviors, injuries, and demographics. Additional information was abstracted from patient medical record: comorbidities, medications, and discharge information. Data are presented descriptively. Forty-nine patients were interviewed: average age was 78 years; White (93.9%); female (53.1%); and most (63.3%) had fallen before. The most commonly reported fall factors and injuries included those occurring at home without agency services (65.0%), on hard flooring (51.1%), with laced shoes (44.2%), and with walkers (36.7%) and contained contusion/open wound of head (61.2%). Survey time was anecdotally estimated at 10-15 min. Preliminary data suggest that prevention efforts should emphasize on educating older adults to focus on ambulation, body position, and use of assistive devices in their daily activities. The development of a systematic and organized registry that documents scene data would inform public health agencies to develop fall prevention programs that promote older adult safety. Furthermore, it would provide a large sample size to test factor associations with injury severity.

  11. Medication coaching program for patients with minor stroke or TIA: A pilot study

    Sides, Elizabeth G; Zimmer, Louise O; Wilson, Leslie; Pan, Wenqin; Olson, DaiWai M; Peterson, Eric D; Bushnell, Cheryl


    Abstract Background Patients who are hospitalized with a first or recurrent stroke often are discharged with new medications or adjustment to the doses of pre-admission medications, which can be confusing and pose safety issues if misunderstood. The purpose of this pilot study was to assess the feasibility of medication coaching via telephone after discharge in patients with stroke. Methods Two-arm pilot study of a medication coaching program with 30 patients (20 intervention, 10 control). Co...

  12. Cross-sectional study of neck pain and cervical sagittal alignment in air force pilots.

    Moon, Bong Ju; Choi, Kyong Ho; Yun, Chul; Ha, Yoon


    There is a high prevalence of neck pain in air force pilots; however, the causes are not clear and are considered work-related. Kyphotic changes in the cervical spine have been known to cause neck pain. In this study, we investigated the association between neck pain and cervical kyphosis in air force pilots. This is a cross-sectional study of 63 Republic of South Korea Air Force pilots. We examined the C2-7 absolute rotation angle (ARA) using the posterior tangent method and other radiologic parameters on whole spine lateral radiographs. We divided the participants into a neck pain group (N = 32) and no neck pain group (N = 31), and subsequently analyzed the difference in radiographic parameters and clinical data between the two groups. There were no significant differences found in age, body mass index, total flight time, or aerobic or anaerobic exercise between the neck pain and control groups. The fighter pilots had higher 1-yr prevalence of neck pain than nonfighter pilots (84.4% vs. 15.6%). The lower C2-7 ARA (OR = 0.91, 95% CI 0.846, 0.979) and fighter type aircrafts (OR = 3.93, 95% CI 1.104, 13.989) were associated with neck pain. Fighter pilots experienced neck pain more frequently than the nonfighter pilots. Those fighter pilots suffering from neck pain were shown to have more kyphotic changes in the cervical spine than control pilots through evaluation of whole spine lateral radiographs using the posterior tangent method. These key findings suggest that the forces involved in flying a fighter type aircraft may affect cervical alignment and neck pain.

  13. Contextual and behavioral control of antipsychotic sensitization induced by haloperidol and olanzapine.

    Zhang, Chen; Li, Ming


    Repeated administration of haloperidol (HAL) and olanzapine (OLZ) causes a progressively enhanced disruption of the conditioned avoidance response (CAR) and a progressively enhanced inhibition of phencyclidine (PCP)-induced hyperlocomotion in rats (termed antipsychotic sensitization). Both actions are thought to reflect intrinsic antipsychotic activity. The present study examined the extent to which antipsychotic-induced sensitization in one model (e.g. CAR) can be transferred or maintained in another (e.g. PCP hyperlocomotion) as a means of investigating the contextual and behavioral controls of antipsychotic sensitization. Well-trained male Sprague-Dawley rats were first repeatedly tested in the CAR or the PCP (3.2 mg/kg, subcutaneously) hyperlocomotion model under HAL or OLZ for 5 consecutive days. Then they were switched to the other model and tested for the expression of sensitization. Finally, all rats were switched back to the original model and retested for the expression of sensitization. Repeated HAL or OLZ treatment progressively disrupted avoidance responding and decreased PCP-induced hyperlocomotion, indicating a robust sensitization. When tested in a different model, rats previously treated with HAL or OLZ did not show a stronger inhibition of CAR-induced or PCP-induced hyperlocomotion than those treated with these drugs for the first time; however, they did show such an effect when tested in the original model in which they received repeated antipsychotic treatment. These findings suggest that the expression of antipsychotic sensitization is strongly influenced by the testing environment and/or selected behavioral response under certain experimental conditions. Distinct contextual cues and behavioral responses may develop an association with unconditional drug effects through a Pavlovian conditioning process. They may also serve as occasion setters to modulate the expression of sensitized responses. As antipsychotic sensitization mimics the clinical

  14. ITRAP - an international pilot study on border monitoring systems

    Beck, P.; Duftschmid, K.E.


    The paper describes the design and preliminary results of an extended pilot study of commercially available monitoring systems for the detection of nuclear and other radioactive materials at borders. The study consists of a laboratory test phase and field tests at the Austrian/Hungarian border and the Vienna airport, each for a duration of one year. The results will be used to derive realistic performance requirements for border control systems in view of optimized technical and economic conditions as well as to propose an 'investigation level'. The ITRAP study consists of three phases. In the first phase equipment currently available on the market is subjected to laboratory testing at the Austrian Research Centres Seibersdorf. The instrument categories include hand-held, portable, and fixed-installed equipment. The test criteria defined as minimum requirements have been established together with the manufacturers. The laboratory tests started in May 1998 and will last until end of this year. During the second phase, the field study, equipment passing the laboratory tests will be installed at a major Austrian-Hungarian border crossing (Nickelsdorf) for monitoring of cars, trucks and trains, as well as at the Vienna airport for pedestrians, luggage and cargo. In this phase the results gained from the lab tests about the 'fitness for use' will be verified in practice, in close co-operation with the law enforcement officers at the borders. Also training issues and questions of maintenance and support shall be evaluated. In the third phase, realistic specifications and performance requirements shall be derived with the help of international experts and selected specialists from the users and manufacturers. The results of the field study will focus not only on the technical aspects of monitoring equipment (e.g. detection threshold and rate of false alarms) but also on the operational (e.g. ease of use, reliability, training requirements, field support) and economic

  15. Involving Medical Students in Informed Consent: A Pilot Study.

    Chiapponi, Costanza; Meyer, Frank; Jannasch, Olof; Arndt, Stephan; Stübs, Patrick; Bruns, Christiane J


    students taking part in this teaching unit found that this exercise represents a significant improvement of clinical teaching and recommended to introduce this teaching unit as a standard on the normal wards. Students teaching patients (SteP) appears to be an easy and cost-efficient tool to improve patients' education and students' learning. Students become aware of how difficult it is to explain surgical procedures and complications to patients and patients are better informed about their treatment. We plan to (i) introduce the STeP protocol as a standard teaching project in daily clinical routine and (ii) continue the pilot study to reach representative student and patient numbers for a possible final statement and derived recommendation.

  16. Using Smartphones to Monitor Bipolar Disorder Symptoms: A Pilot Study.

    Beiwinkel, Till; Kindermann, Sally; Maier, Andreas; Kerl, Christopher; Moock, Jörn; Barbian, Guido; Rössler, Wulf


    Relapse prevention in bipolar disorder can be improved by monitoring symptoms in patients' daily life. Smartphone apps are easy-to-use, low-cost tools that can be used to assess this information. To date, few studies have examined the usefulness of smartphone data for monitoring symptoms in bipolar disorder. We present results from a pilot test of a smartphone-based monitoring system, Social Information Monitoring for Patients with Bipolar Affective Disorder (SIMBA), that tracked daily mood, physical activity, and social communication in 13 patients. The objective of this study was to investigate whether smartphone measurements predicted clinical symptoms levels and clinical symptom change. The hypotheses that smartphone measurements are (1) negatively related to clinical depressive symptoms and (2) positively related to clinical manic symptoms were tested. Clinical rating scales were administered to assess clinical depressive and manic symptoms. Patients used a smartphone with the monitoring app for up to 12 months. Random-coefficient multilevel models were computed to analyze the relationship between smartphone data and externally rated manic and depressive symptoms. Overall clinical symptom levels and clinical symptom changes were predicted by separating between-patient and within-patient effects. Using established clinical thresholds from the literature, marginal effect plots displayed clinical relevance of smartphone data. Overall symptom levels and change in clinical symptoms were related to smartphone measures. Higher overall levels of clinical depressive symptoms were predicted by lower self-reported mood measured by the smartphone (beta=-.56, Psmartphone (ie, cell tower movements: beta=-.11, P=.03). Higher overall levels of clinical manic symptoms were predicted by lower physical activity on the smartphone (ie, distance travelled: beta=-.37, Psmartphone (beta=-.17, Psmartphone measurements, but not all smartphone measures predicted the occurrence of

  17. Bilingual Text4Walking Food Service Employee Intervention Pilot Study.

    Buchholz, Susan Weber; Ingram, Diana; Wilbur, JoEllen; Fogg, Louis; Sandi, Giselle; Moss, Angela; Ocampo, Edith V


    Half of all adults in the United States do not meet the level of recommended aerobic physical activity. Physical activity interventions are now being conducted in the workplace. Accessible technology, in the form of widespread usage of cell phones and text messaging, is available for promoting physical activity. The purposes of this study, which was conducted in the workplace, were to determine (1) the feasibility of implementing a bilingual 12-week Text4Walking intervention and (2) the effect of the Text4Walking intervention on change in physical activity and health status in a food service employee population. Before conducting the study reported here, the Text4Walking research team developed a database of motivational physical activity text messages in English. Because Hispanic or Latino adults compose one-quarter of all adults employed in the food service industry, the Text4Walking team translated the physical activity text messages into Spanish. This pilot study was guided by the Physical Activity Health Promotion Framework and used a 1-group 12-week pre- and posttest design with food service employees who self-reported as being sedentary. The aim of the study was to increase the number of daily steps over the baseline by 3000 steps. Three physical activity text messages were delivered weekly. In addition, participants received 3 motivational calls during the study. SPSS version 19.0 and R 3.0 were used to perform the data analysis. There were 33 employees who participated in the study (57.6% female), with a mean age of 43.7 years (SD 8.4). The study included 11 Hispanic or Latino participants, 8 of whom requested that the study be delivered in Spanish. There was a 100% retention rate in the study. At baseline, the participants walked 102 (SD 138) minutes/day (per self-report). This rate increased significantly (P=.008) to 182 (SD 219) minutes/day over the course of the study. The participants had a baseline mean of 10,416 (SD 5097) steps, which also increased

  18. Pre-feasibility study template for nZEB pilot projects development

    Crespo Sánchez, Eva


    This document corresponds to Task 5.2 NZEB pilot projects development, Deliverable 5.2 Basic project conceptual design with feasibility analysis for eight pilot project of the SUSTAINCO project and should present a structure of pre-feasibility studies for eight NZEB projects implementation. It aims to give an overview of how SUSTAINCO project implementation is to be prepared and which technical and financial parameters to concern.

  19. Hand Robotic Therapy in Children with Hemiparesis: A Pilot Study.

    Bishop, Lauri; Gordon, Andrew M; Kim, Heakyung


    The aim of this study was to understand the impact of training with a hand robotic device on hand paresis and function in a population of children with hemiparesis. Twelve children with hemiparesis (mean age, 9 [SD, 3.64] years) completed participation in this prospective, experimental, pilot study. Participants underwent clinical assessments at baseline and again 6 weeks later with instructions to not initiate new therapies. After these assessments, participants received 6 weeks of training with a hand robotic device, consisting of 1-hour sessions, 3 times weekly. Assessments were repeated on completion of training. Results showed significant improvements after training on the Assisting Hand Assessment (mean difference, 2.0 Assisting Hand Assessment units; P = 0.011) and on the upper-extremity component of the Fugl-Meyer scale (raw score mean difference, 4.334; P = 0.001). No significant improvements between pretest and posttest were noted on the Jebsen-Taylor Test of Hand Function, the Quality of Upper Extremity Skills Test, or the Pediatric Evaluation of Disability Inventory after intervention. Total active mobility of digits and grip strength also failed to demonstrate significant changes after training. Participants tolerated training with the hand robotic device, and significant improvements in bimanual hand use, as well as impairment-based scales, were noted. Improvements were carried over into bimanual skills during play. Complete the self-assessment activity and evaluation online at CME OBJECTIVES: Upon completion of this article, the reader should be able to: (1) Understand key components of neuroplasticity; (2) Discuss the benefits of robotic therapy in the recovery of hand function in pediatric patients with hemiplegia; and (3) Appropriately incorporate robotic therapy into the treatment plan of pediatric patients with hemiplegia. Advanced ACCREDITATION: The Association of Academic Physiatrists is accredited by the

  20. Schizophrenia relapse after stopping olanzapine treatment during pregnancy: a case report

    Ifteni P


    Full Text Available Petru Ifteni,1,2 Marius A Moga,1 Victoria Burtea,1,2 Christoph U Correll3,4 1Faculty of Medicine, Transilvania University, Brasov, Romania; 2Psychiatry and Neurology Hospital, Brasov, Romania; 3Department of Psychiatry, The Zucker Hillside Hospital, North Shore-Long Island Jewish (LIJ Health System, New York, NY, USA; 4Hofstra North Shore-LIJ School of Medicine, New York, NY, USA Abstract: Women with schizophrenia have a high risk for symptom exacerbation or relapse during pregnancy and thereafter. Relapses are more frequent when antipsychotics are discontinued. This paper describes the case of a 28-year old woman with schizophrenia who continued treatment with olanzapine during the first trimester. Olanzapine, a second-generation antipsychotic, was administered at a therapeutic dose from week 1 of gestation until week 13 when she reported the pregnancy to her psychiatrist. Despite the psychiatrist’s recommendation to continue treatment, the patient stopped olanzapine at 20 weeks. She was hospitalized at week 36 for a schizophrenia relapse and was transferred to the obstetrics department where she gave birth by Cesarean section to a normal child. This case is important, illustrating the perils of unplanned pregnancy during antipsychotic treatment and abrupt discontinuation. Ultimately, clinical decisions should be made on a case-by-case basis, weighing the risks to the mother in terms of symptom exacerbation and relapse if antipsychotic treatment is discontinued, and the potential risk to the fetus regarding possible teratogenic effects of continued antipsychotic treatment. Keywords: relapse, pregnancy, schizophrenia, olanzapine

  1. Study on designing a complete pilot plant for processing sandstone ores in Palua-Parong area

    Le Quang Thai; Tran Van Son; Tran The Dinh; Trinh Nguyen Quynh; Vu Khac Tuan


    Design work is the first step of the construction and operation of pilot plant. Thus, the project Study on designing a complete pilot plant for processing sandstone ores in Palua - Parong area was conducted to design a pilot plant for testing entire technological process to obtain yellowcake. Based on a literature review of uranium ore processing technology in the world, information of ore and previous research results of uranium ore in PaLua - PaRong area at the Institute for Technology of Radioactive and Rare Elements, a suitable technological flowsheet for processing this ore has been selected. The size, location of the pilot plant and planed experiments has been selected during the implementation of this project, in which basic parameters, designed system of equipment, buildings, ect. were also calculated. (author)

  2. Coal resources available for development; a methodology and pilot study

    Eggleston, Jane R.; Carter, M. Devereux; Cobb, James C.


    Coal accounts for a major portion of our Nation's energy supply in projections for the future. A demonstrated reserve base of more than 475 billion short tons, as the Department of Energy currently estimates, indicates that, on the basis of today's rate of consumption, the United States has enough coal to meet projected energy needs for almost 200 years. However, the traditional procedures used for estimating the demonstrated reserve base do not account for many environmental and technological restrictions placed on coal mining. A new methodology has been developed to determine the quantity of coal that might actually be available for mining under current and foreseeable conditions. This methodology is unique in its approach, because it applies restrictions to the coal resource before it is mined. Previous methodologies incorporated restrictions into the recovery factor (a percentage), which was then globally applied to the reserve (minable coal) tonnage to derive a recoverable coal tonnage. None of the previous methodologies define the restrictions and their area and amount of impact specifically. Because these restrictions and their impacts are defined in this new methodology, it is possible to achieve more accurate and specific assessments of available resources. This methodology has been tested in a cooperative project between the U.S. Geological Survey and the Kentucky Geological Survey on the Matewan 7.5-minute quadrangle in eastern Kentucky. Pertinent geologic, mining, land-use, and technological data were collected, assimilated, and plotted. The National Coal Resources Data System was used as the repository for data, and its geographic information system software was applied to these data to eliminate restricted coal and quantify that which is available for mining. This methodology does not consider recovery factors or the economic factors that would be considered by a company before mining. Results of the pilot study indicate that, of the estimated

  3. Can Subclinical Rickets Cause SCFE? A Prospective, Pilot Study.

    Arkader, Alexandre; Woon, Regina P; Gilsanz, Vicente


    Slipped capital femoral epiphysis (SCFE) is a common disorder of the growing hip; however, its etiology remains unknown. Vitamin D (25-OH) is a major regulator of bone homeostasis and calcium metabolism. Vitamin D deficiency is one of the major causes of rickets, and rickets has been associated with SCFE. Increased body mass index (BMI) has been linked to SCFE and obese children are known to have lower vitamin D levels. Therefore, we hypothesize that children who develop SCFE may have subclinical rickets predisposing them to the development of physeal disease. This was a pilot, prospective study designed to determine the relationship between vitamin D, bone, muscle, and fat in patients with SCFE. We enrolled 20 consecutive patients with idiopathic SCFE aged 9 to 14 years. Upon diagnosis, vitamin D, PTH, T4, and thyroid-stimulating hormone blood levels were obtained. A single-slice computed tomography was used to measure cortical bone density (CBD) of the femur. Demographics, BMI, and the results obtained were compared to generate a relationship between vitamin D levels and SCFE. Twenty patients were enrolled, 13 males and 7 females, at an average age of 12 years (range, 9 to 14 y), and mean BMI% was 93.9 (range, 81.3 to 99.5). There were 15 stable and 5 unstable SCFE. Overall, mean and SD values for vitamin D, 25-OH were within the normal range (43.9 ± 13.5). We found no difference in values in vitamin D between nonobese (BMI < 95%) and obese (BMI ≥ 95%) subjects (34.8 ± 16.8 vs. 51.6 ± 22.4, P = 0.144). Moreover, we found no difference in CBD between these 2 groups (1126 ± 33.1 vs. 1147 ± 41.2, P = 0.333). There was no relation between blood values of vitamin D and measures of CBD. Although obese children are known to have lower levels of vitamin D and a higher prevalence of SCFE, we found no correlation between low vitamin D and the development of SCFE in this subset of patients.

  4. Olanzapine-Induced Diabetic Ketoacidosis and Neuroleptic Malignant Syndrome with Rhabdomyolysis: A Case Report

    Young Kyoung Sa


    Full Text Available Atypical antipsychotics have replaced conventional antipsychotics in the treatment of schizophrenia because they have less of a propensity to cause undesirable neurologic adverse events including extrapyramidal symptoms, tardive dyskinesia, and neuroleptic malignant syndrome (NMS. However, atypical antipsychotics have been known to result in various metabolic complications such as impaired glucose tolerance, diabetes and even diabetic ketoacidosis (DKA. In addition, a number of NMS cases have been reported in patients treated with atypical antipsychotics, although the absolute incidence of neurologic side effects is currently significantly low. Here, we report a patient who simultaneously developed DKA, acute renal failure and NMS with rhabdomyolysis after olanzapine treatment. Olanzapine-induced metabolic complications and NMS were dramatically improved with cessation of the olanzapine treatment and initiation of supportive management including fluid therapy, hemodialysis, and intensive glycemic control using insulin. At short-term follow-up, insulin secretion was markedly recovered as evidenced by a restoration of serum C-peptide level, and the patient no longer required any hypoglycemic medications. Despite the dramatic increase in the use of atypical antipsychotics treatment, individualized treatments along with careful monitoring may be prudent for high risk or vulnerable patients in order to avoid the development of metabolic side effects.

  5. Does participation in a weight control program also improve clinical and functional outcomes for Chinese patients with schizophrenia treated with olanzapine?

    Montgomery W


    Full Text Available William Montgomery,1 Tamas Treuer,2 Wenyu Ye,3 Hai Bo Xue,4 Sheng Hu Wu,4 Li Liu,4 Zbigniew Kadziola,5 Michael D Stensland,6 Haya Ascher-Svanum7 1Global Health Outcomes Eli Lilly Australia Pty Ltd, West Ryde, NSW, Australia; 2Neuroscience Research, Eli Lilly and Company, Budapest, Hungary; 3Global Statistical Sciences, Lilly Suzhou Pharmaceutical Company, Ltd, Shanghai, People's Republic of China; 4Medical Department, Lilly Suzhou Pharmaceutical Company, Ltd, Shanghai, People's Republic of China; 5Global Statistical Sciences, Eli Lilly GmbH, Vienna, Republic of Austria; 6Agile Outcomes Research, Inc., Rochester, MN, USA; 7Global Health Outcomes, Eli Lilly and Company, Indianapolis, IN, USA Objectives: This study examined whether participation in a weight control program (WCP by patients with schizophrenia treated with olanzapine was also associated with improvements in clinical and functional outcomes. Methods: A post-hoc analysis was conducted using data from the Chinese subgroup (n=330 of a multi-country, 6-month, prospective, observational study of outpatients with schizophrenia who initiated or switched to oral olanzapine. At study entry and monthly visits, participants were assessed with the Clinical Global Impression of Severity, and measures of patient insight, social activities, and work impairment. The primary comparison was between the 153 patients who participated in a WCP at study entry (n=93 or during the study (n=60 and the 177 patients who did not participate in a weight control program (non-WCP. Mixed Models for Repeated Measures with baseline covariates were used to compare outcomes over time. Kaplan–Meier survival analysis was used to assess time to response. Results: Participants had a mean age of 29.0 years and 29.3 years, and 51.0% and 57.6% were female for WCP and non-WCP groups, respectively. Average initiated daily dose for olanzapine was 9.5±5.4 mg. WCP participants gained less weight than non-participants (3.9 kg vs

  6. [Functional Neuroimaging Pilot Study of Borderline Personality Disorder in Adolescents].

    LeBoeuf, Amélie; Guilé, Jean-Marc; Labelle, Réal; Luck, David

    Borderline personality disorder (BPD) is being increasingly recognized by clinicians working with adolescents, and the reliability and validity of the diagnosis have been established in the adolescent population. Adolescence is known to be a period of high risk for BPD development as most patients identify the onset of their symptoms to be in the adolescent period. As with other mental health disorders, personality disorder, are thought to result from the interaction between biological and environmental factors. Functional neuroimaging studies are reporting an increasing amount of data on abnormal neuronal functions in BPD adult patients. However, no functional neuroimaging studies have been conducted in adolescents with BPD.Objectives This pilot project aims to evaluate the feasibility of a functional magnetic resonance imaging (fMRI) study coupled with clinical and psychological measures in adolescent girls with a diagnosis of BPD. It also aims to identify neuronal regions of interest (ROI) for the study of BPD in adolescent girls.Method Six female adolescents meeting DSM-IV criteria for BPD and 6 female adolescents without psychiatric disorder were recruited. Both groups were evaluated for BPD symptoms, depressive symptoms, impulsivity, affective lability, and other potential psychiatric comorbidities. We used fMRI to compare patterns of regional brain activation between these two groups as they viewed 20 positive, 20 negative and 20 neutral emotion-inducing pictures, which were presented in random order.Results Participants were recruited over a period of 22 months. The protocol was well tolerated by participants. Mean age of the BPD group and control group was 15.8 ± 0.9 years-old and 15.5 ± 1.2 years-old respectively. Psychiatric comorbidity and use of medication was common among participants in the BPD group. This group showed higher impulsivity and affective lability scores. For the fMRI task, BPD patients demonstrated greater differences in activation

  7. Evaluating priority setting success in healthcare: a pilot study

    Upshur Ross


    Full Text Available Abstract Background In healthcare today, decisions are made in the face of serious resource constraints. Healthcare managers are struggling to provide high quality care, manage resources effectively, and meet changing patient needs. Healthcare managers who are constantly making difficult resource decisions desire a way to improve their priority setting processes. Despite the wealth of existing priority setting literature (for example, program budgeting and marginal analysis, accountability for reasonableness, the 'describe-evaluate-improve' strategy there are still no tools to evaluate how healthcare resources are prioritised. This paper describes the development and piloting of a process to evaluate priority setting in health institutions. The evaluation process was designed to examine the procedural and substantive dimensions of priority setting using a multi-methods approach, including a staff survey, decision-maker interviews, and document analysis. Methods The evaluation process was piloted in a mid-size community hospital in Ontario, Canada while its leaders worked through their annual budgeting process. Both qualitative and quantitative methods were used to analyze the data. Results The evaluation process was both applicable to the context and it captured the budgeting process. In general, the pilot test provided support for our evaluation process and our definition of success, (i.e., our conceptual framework. Conclusions The purpose of the evaluation process is to provide a simple, practical way for an organization to better understand what it means to achieve success in its priority setting activities and identify areas for improvement. In order for the process to be used by healthcare managers today, modification and contextualization of the process are anticipated. As the evaluation process is applied in more health care organizations or applied repeatedly in an organization, it may become more streamlined.

  8. Feasibility and Pilot Studies in Palliative Care Research: A Systematic Review.

    Jones, Terry A; Olds, Timothy S; Currow, David C; Williams, Marie T


    Feasibility and pilot study designs are common in palliative care research. Finding standard guidelines on the structure and reporting of these study types is difficult. In feasibility and pilot studies in palliative care research, to determine 1) how commonly a priori feasibility are criteria reported and whether results are subsequently reported against these criteria? and 2) how commonly are participants' views on acceptability of burden of the study protocol assessed? Four databases (OVID Medline, EMBASE, CINAHL, and PubMed via were searched. Search terms included palliative care, terminal care, advance care planning, hospice, pilot, feasibility, with a publication date between January 1, 2012 and December 31, 2013. Articles were selected and appraised by two independent reviewers. Fifty-six feasibility and/or pilot studies were included in this review. Only three studies had clear a priori criteria to measure success. Sixteen studies reported participant acceptability or burden with measures. Forty-eight studies concluded feasibility. The terms "feasibility" and "pilot" are used synonymously in palliative care research when describing studies that test for feasibility. Few studies in palliative care research outline clear criteria for success. The assessment of participant acceptability and burden is uncommon. A gold standard for feasibility study design in palliative care research that includes both clear criteria for success and testing of the study protocol for participant acceptability and burden is needed. Such a standard would assist with consistency in the design, conduct and reporting of feasibility and pilot studies. Copyright © 2017 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

  9. Early evaluation of patient risk for substantial weight gain during olanzapine treatment for schizophrenia, schizophreniform, or schizoaffective disorder

    Hardy Thomas A


    Full Text Available Abstract Background To make well informed treatment decisions for their patients, clinicians need credible information about potential risk for substantial weight gain. We therefore conducted a post-hoc analysis of clinical trial data, examining early weight gain as a predictor of later substantial weight gain. Methods Data from 669 (Study 1 and 102 (Study 2 olanzapine-treated patients diagnosed with schizophrenia, schizophreniform, or schizoaffective disorder were analyzed to identify and validate weight gain cut-offs at Weeks 1–4 that were predictive of substantial weight gain (defined as an increase of ≥ 5, 7, 10 kg or 7% of baseline weight after approximately 30 weeks of treatment. Baseline characteristics alone, baseline characteristics plus weight change from baseline to Weeks 1, 2, 3 or 4, and weight change from baseline to Weeks 1, 2, 3, or 4 alone were evaluated as predictors of substantial weight gain. Similar analyses were performed to determine BMI increase cut-offs at Weeks 1–4 of treatment that were predictive of substantial increase in BMI (1, 2 or 3 kg/m2 increase from baseline. Results At Weeks 1 and 2, predictions based on early weight gain plus baseline characteristics were more robust than those based on early weight gain alone. However, by Weeks 3 and 4, there was little difference between the operating characteristics associated with these two sets of predictors. The positive predictive values ranged from 30.1% to 73.5%, while the negative predictive values ranged from 58.1% to 89.0%. Predictions based on early BMI increase plus baseline characteristics were not uniformly more robust at any time compared to those based on early BMI increase alone. The positive predictive values ranged from 38.3% to 83.5%, while negative predictive values ranged from 42.1% to 84.7%. For analyses of both early weight gain and early BMI increase, results for the validation dataset were similar to those observed in the primary dataset

  10. Interprofessional Collaborative Practice to Improve Patient Outcomes: A Pilot Study

    Jennifer Styron


    Full Text Available This project focused on a pilot project implemented during the 2013-2014 academic year. The overall purpose was to facilitate interprofessional collaborative practice innovations through the development of leadership, core competencies, and the use of technology, especially among nurses. Nursing, medicine, and physician assistant students were educated on the IOM competencies for interprofessional teams and the core competencies identified by the Interprofessional Education Collaborative Expert Panel [1] to develop knowledge, skills, and attitudes needed to practice in the collaborative practice environments. The project addressed four goals: Develop faculty expertise and leadership in interprofessional collaborative practice to provide a current, high quality education to nursing, physician assistant, and medical students; Implement a culturally responsive and respectful collaborative interprofessional practice curriculum to prepare nurses, physician assistants, and medical students to deliver high quality, efficient, team-based care in a dynamically evolving environment; Focus interprofessional collaborative practice education on models and practices that lead to improvement in patient outcomes; and Evaluate the program and disseminate best practices. Findings from this pilot include strategies to engage different health professions' students and faculty, partnering with community agencies, building an effective interprofessional team to guide the project, and seeking funding for extension and expansion of the offerings.

  11. A Pilot Study on the effects of Music Therapy on Frontotemporal Dementia - developing a research protocol

    Ridder, Hanne Mette Ochsner; Wigram, Tony; Ottesen, Anne Marie


    , and pharmacological treatment of the psychiatric symptoms is difficult, requiring specialist proficiency in the field. Pilot study: As there is not yet sufficient research that examines the effects of non-pharmacologic treatment with this group there is a need to develop valid and reliable research protocols....... As an example of a non-pharmacologic treatment procedure music therapy was investigated. With the focus to develop a research protocol for a future larger population study a pilot study was carried out. In two case studies a combination of data collection methods were examined with the overall goal to document...... changes in intersubjectivity. In this pilot testing there was a specific interest in selecting a relevant and manageable dementia specific instrument for measuring quality of life and relating it with other instruments. Following three instruments were tested: the Altzheimers Disease-Related Quality...

  12. Pilot Study of Flow and Meaningfulness as Psychological Learning Concepts in Patient Education: A Short Report

    Nicic, Sara; Nørby, Karina; Bruun Johansen, Clea


    of this study was to investigate the applicability of these concepts of positive psychological theory in a patient education setting. Methods: This pilot study combines participating observation of group based patient education and 8 qualitative interviews with 4 patients with type 2 diabetes. Meaning......Abstract Background: The aim of this pilot study was to explore patient experiences of meaningfulness and flow related to group based patient education in type 2 diabetes. Meaningfulness and flow are underexposed as psychological learning concepts in patient education, and the ambition...

  13. Pilot non dialysis chronic renal insufficiency study (P-ND-CRIS): a pilot study of an open prospective hospital-based French cohort.

    Massol, Jacques; Janin, Gérard; Bachot, Camille; Gousset, Christophe; Deville, Geoffroy Sainte-Claire; Chalopin, Jean-Marc


    Before establishing a prospective cohort, an initial pilot study is recommended. However, there are no precise guidelines on this subject. This paper reports the findings of a French regional pilot study carried out in three nephrology departments, before realizing a major prospective Non Dialysis Chronic Renal Insufficiency study (ND-CRIS). We carried out an internal pilot study. The objectives of this pilot study were to validate the feasibility (regulatory approval, providing patients with information, availability of variables, refusal rate of eligible patients) and quality criteria (missing data, rate of patients lost to follow-up, characteristics of the patients included and non-included eligible patients, quality control of the data gathered) and estimate the human resources necessary (number of clinical research associates required). The authorizations obtained (CCTIRS - CNIL) and the contracts signed with hospitals have fulfilled the regulatory requirements. After validating the information on the study provided to patients, 1849 of them were included in three centres (university hospital, intercommunal hospital, town hospital) between April 2012 and September 2015. The low refusal rate (51 patients) and the characteristics of non-included patients have confirmed the benefit for patients of participating in the study and provide evidence of the feasibility and representativeness of the population studied. The lack of missing data on the variables studied, the quality of the data analyzed and the low number of patients lost to follow-up are evidence of the quality of the study. By taking into account the time spent by CRAs to enter data and to travel, as well as the annual patient numbers in each hospital, we estimate that five CRAs will be required in total. With no specific guidelines on how to realize a pilot study before implementing a major prospective cohort, we considered it pertinent to report our experience of P-ND-CRIS. This experience confirms

  14. Use of digital devices in coaching of patients – a pilot study

    Thybo Pihl, Gitte; Ammentorp, Jette

    that it could optimise the treatment and improve health of the patient. The idea was to empower the patient by: developing an easy method of collecting patient related data. Teach and motivate the patient to change life style on basis of chosen goals and collected data. Methods: A pilot study has been conducted...... was to describe the first experiences from a pilot study, and to discuss the new questions and perspectives in communication research....... in 2016 with the aim of developing the intervention when it comes to individual adjustment of the mobile app and wearables, and form and standard of coaching. Two patients with chronic diseases were included in the pilot study. One patient with prostate cancer and one patient with urolithiasis...

  15. [Fear of falling in a fall clinic for geriatric patients: a pilot study

    Dautzenberg, P.LJ.; Buurman, B.H.; Loonen, A.J.; Wouters, C.J.; Olde Rikkert, M.G.M.


    OBJECTIVE: In this pilot study we want to determine how often fear of falling occurs in geriatric patients visiting a fall clinic and to study the characteristics of fear of falling and its consequences. DESIGN: Retrospective study of patient's records. METHOD: A random sample of 100 medical records

  16. Study of the CMS Phase-1 Pixel Pilot Blade Reconstruction

    Vami, Tamas Almos


    The Compact Muon Solenoid (CMS) detector is one of two general-purpose detectors that measure the products of high energy particle interactions in the Large Hadron Collider (LHC) at CERN. The silicon pixel detector is the innermost component of the CMS tracking system. The detector which was in operation between 2009 and 2016 has now been replaced with an upgraded one in the beginning of 2017. During the previous shutdown period of the LHC, a prototype readout system and a third disk was inserted into the old forward pixel detector with eight prototype blades constructed using the new digital read-out chips. Testing the performance of these pilot modules enabled us to gain operational experience with the upgraded detector. In this paper, the reconstruction and analysis of the data taken with the new modules are presented including information on the calibration of the reconstruction software. The hit finding efficiency and track-hit residual distributions are also shown.

  17. Medical symptoms among pilots associated with work and home environments: a 3-year cohort study.

    Fu, Xi; Lindgren, Torsten; Norbäck, Dan


    To study associations between the cockpit environment, psychosocial work environment, home environment, and medical symptoms in a cohort of commercial pilots followed over 3 yr. A standardized questionnaire was mailed in February-March 1997 to all Stockholm-based pilots on duty in a Scandinavian flight company (N = 622); 577 (93%) participated. During this time smoking was allowed on long haul flights, but not on shorter flights. Smoking was prohibited on all flights after September 1997. The same questionnaire was sent to the cohort of 577 pilots in February-March 2000; 436 participated (76%). The questionnaire contained questions on symptoms, the psychosocial work environment, and the home environment. Associations were investigated using multiple logistic and ordinal regression. Symptoms were common, especially eye symptoms (38.5%), nose symptoms (39.9%), and tiredness (29.9%). Pilots exposed to environmental tobacco smoke (ETS) on long haul flights had more eye symptoms (odds ratio = 1.91) and tiredness (odds ratio = 2.73). These symptoms were reduced when no longer exposed to ETS. Those who started working on long haul flights developed more nose symptoms. Pilots reporting increased work demands developed more nose and dermal symptoms and tiredness and those with decreased work control developed more eye symptoms. Pilots living in new houses, multifamily houses, and in recently painted homes reported more symptoms. Eliminating ETS exposure on board reduced medical symptoms. Further work to reduce ETS exposure globally is needed. Psychosocial aspects of the work environment for commercial pilots should be considered, as well as the home environment.

  18. Promoting childbirth companions in South Africa: a randomised pilot study

    Smith Helen


    Full Text Available Abstract Background Most women delivering in South African State Maternity Hospitals do not have a childbirth companion; in addition, the quality of care could be better, and at times women are treated inhumanely. We piloted a multi-faceted intervention to encourage uptake of childbirth companions in state hospitals, and hypothesised that lay carers would improve the behaviour of health professionals. Methods We conducted a pilot randomised controlled trial of an intervention to promote childbirth companions in hospital deliveries. We promoted evidence-based information for maternity staff at 10 hospitals through access to the World Health Organization Reproductive Health Library (RHL, computer hardware and training to all ten hospitals. We surveyed 200 women at each site, measuring companionship, and indicators of good obstetric practice and humanity of care. Five hospitals were then randomly allocated to receive an educational intervention to promote childbirth companions, and we surveyed all hospitals again at eight months through a repeat survey of postnatal women. Changes in median values between intervention and control hospitals were examined. Results At baseline, the majority of hospitals did not allow a companion, or access to food or fluids. A third of women were given an episiotomy. Some women were shouted at (17.7%, N = 2085, and a few reported being slapped or struck (4.3%, N = 2080. Despite an initial positive response from staff to the childbirth companion intervention, we detected no difference between intervention and control hospitals in relation to whether a companion was allowed by nursing staff, good obstetric practice or humanity of care. Conclusion The quality and humanity of care in these state hospitals needs to improve. Introducing childbirth companions was more difficult than we anticipated, particularly in under-resourced health care systems with frequent staff changes. We were unable to determine whether the presence

  19. Promoting childbirth companions in South Africa: a randomised pilot study

    Brown, Heather; Hofmeyr, G Justus; Nikodem, V Cheryl; Smith, Helen; Garner, Paul


    Background Most women delivering in South African State Maternity Hospitals do not have a childbirth companion; in addition, the quality of care could be better, and at times women are treated inhumanely. We piloted a multi-faceted intervention to encourage uptake of childbirth companions in state hospitals, and hypothesised that lay carers would improve the behaviour of health professionals. Methods We conducted a pilot randomised controlled trial of an intervention to promote childbirth companions in hospital deliveries. We promoted evidence-based information for maternity staff at 10 hospitals through access to the World Health Organization Reproductive Health Library (RHL), computer hardware and training to all ten hospitals. We surveyed 200 women at each site, measuring companionship, and indicators of good obstetric practice and humanity of care. Five hospitals were then randomly allocated to receive an educational intervention to promote childbirth companions, and we surveyed all hospitals again at eight months through a repeat survey of postnatal women. Changes in median values between intervention and control hospitals were examined. Results At baseline, the majority of hospitals did not allow a companion, or access to food or fluids. A third of women were given an episiotomy. Some women were shouted at (17.7%, N = 2085), and a few reported being slapped or struck (4.3%, N = 2080). Despite an initial positive response from staff to the childbirth companion intervention, we detected no difference between intervention and control hospitals in relation to whether a companion was allowed by nursing staff, good obstetric practice or humanity of care. Conclusion The quality and humanity of care in these state hospitals needs to improve. Introducing childbirth companions was more difficult than we anticipated, particularly in under-resourced health care systems with frequent staff changes. We were unable to determine whether the presence of a lay carer impacted

  20. Mission X: Train Like an Astronaut Pilot Study

    Lloyd, Charles W.; Olivotto, C.; Boese, A.; Spiero, F.; Galoforo, G.; Niihori, M.


    Mission X: Train Like an Astronaut is an international educational challenge focusing on fitness and nutrition as we encourage students to "train like an astronaut." Teams of students (aged 8-12) learn principles of healthy eating and exercise, compete for points by finishing training modules, and get excited about their future as "fit explorers." The 18 core exercises (targeting strength, endurance, coordination, balance, spatial awareness, and more) involve the same types of skills that astronauts learn in their training and use in spaceflight. This first-of-its-kind cooperative outreach program has allowed 14 space agencies and various partner institutions to work together to address quality health/fitness education, challenge students to be more physically active, increase awareness of the importance of lifelong health and fitness, teach students how fitness plays a vital role in human performance for exploration, and inspire and motivate students to pursue careers in STEM fields. The project was initiated in 2009 in response to a request by the International Space Life Sciences Working Group. USA, Netherlands, Italy, France, Germany, Austria, Colombia, Spain, and United Kingdom hosted teams for the pilot this past spring, and Japan held a modified version of the challenge. Several more agencies provided input into the preparations. Competing on 131 teams, more than 3700 students from 40 cities worldwide participated in the first round of Mission X. OUTCOMES AND BEST PRACTICES Members of the Mission X core team will highlight the outcomes of this international educational outreach pilot project, show video highlights of the challenge, provide the working group s initial assessment of the project and discuss the future potential of the effort. The team will also discuss ideas and best practices for international partnership in education outreach efforts from various agency perspectives and experiences

  1. Integrating Virtual Worlds with Tangible User Interfaces for Teaching Mathematics: A Pilot Study.

    Guerrero, Graciela; Ayala, Andrés; Mateu, Juan; Casades, Laura; Alamán, Xavier


    This article presents a pilot study of the use of two new tangible interfaces and virtual worlds for teaching geometry in a secondary school. The first tangible device allows the user to control a virtual object in six degrees of freedom. The second tangible device is used to modify virtual objects, changing attributes such as position, size, rotation and color. A pilot study on using these devices was carried out at the "Florida Secundaria" high school. A virtual world was built where students used the tangible interfaces to manipulate geometrical figures in order to learn different geometrical concepts. The pilot experiment results suggest that the use of tangible interfaces and virtual worlds allowed a more meaningful learning (concepts learnt were more durable).

  2. Integrating Virtual Worlds with Tangible User Interfaces for Teaching Mathematics: A Pilot Study

    Graciela Guerrero


    Full Text Available This article presents a pilot study of the use of two new tangible interfaces and virtual worlds for teaching geometry in a secondary school. The first tangible device allows the user to control a virtual object in six degrees of freedom. The second tangible device is used to modify virtual objects, changing attributes such as position, size, rotation and color. A pilot study on using these devices was carried out at the “Florida Secundaria” high school. A virtual world was built where students used the tangible interfaces to manipulate geometrical figures in order to learn different geometrical concepts. The pilot experiment results suggest that the use of tangible interfaces and virtual worlds allowed a more meaningful learning (concepts learnt were more durable.

  3. Final Report on Pilot Studies / Final Report on Classroom Research with STEM and TESL Assessment

    Biel, Carmen; Wake, Jo Dugstad; Hesse, Friedrich

    This Deliverable is the final report on pilot studies within the NEXT-TELL project (D6.7) and furthermore comprises the Deliverable on Classroom Research with STEM and TESL Assessment (D2.9) in order to avoid redundancies between those two Deliverables.......This Deliverable is the final report on pilot studies within the NEXT-TELL project (D6.7) and furthermore comprises the Deliverable on Classroom Research with STEM and TESL Assessment (D2.9) in order to avoid redundancies between those two Deliverables....

  4. A pilot study to determine the effect of radiographer training on radiostereometric analysis imaging technique

    Muharemovic, O; Troelsen, A; Thomsen, M G


    INTRODUCTION: Producing x-ray images for radiostereometric analysis (RSA) is a demanding technique. Suboptimal examinations result in a high percentage of exposure repetition. The aim of this pilot study was to use an experiential training approach to sharpen the skills of radiographers in acquir......INTRODUCTION: Producing x-ray images for radiostereometric analysis (RSA) is a demanding technique. Suboptimal examinations result in a high percentage of exposure repetition. The aim of this pilot study was to use an experiential training approach to sharpen the skills of radiographers...

  5. Case studies of energy efficiency financing in the original five pilot states, 1993-1996

    Farhar, B C; Collins, N E; Walsh, R W


    The purpose of this report is to document progress in state-level programs in energy efficiency financing programs that are linked with home energy rating systems. Case studies are presented of programs in five states using a federal pilot program to amortize the costs of home energy improvements. The case studies present background information, describe the states` program, list preliminary evaluation data and findings, and discuss problems and solution encountered in the programs. A comparison of experiences in pilot states will be used to provide guidelines for program implementers, federal agencies, and Congress. 5 refs.

  6. Resource Allocation Support System (RASS): Summary report of the 1992 pilot study

    Buehring, W.A.; Whitfield, R.G.; Wolsko, T.D.; Kier, P.H.; Absil, M.J.G.; Jusko, M.J.; Sapinski, P.F.


    The Resource Allocation Support System (RASS) is a decision-aiding system being developed to assist the US Department of Energy's (DOE's) Office of Waste Management in program and budget decision making. Four pilot studies were conducted at DOE field offices in summer 1992 to evaluate and improve the RASS design. This report summarizes the combined results of the individual field office pilot studies. Results are presented from different perspectives to illustrate the type of information that would be available from RASS. Lessons learned and directions for future RASS developments are also presented

  7. Olanzapine-induced neuroleptic malignant syndrome in a patient with bipolar affective disorder: Does quetiapine holds the solution?

    Praveen Tripathi


    Full Text Available Neuroleptic Malignant Syndrome (NMS is a rare, severe and life threatening condition induced by antipsychotic medications. It is commonly encountered with the use of first generation antipsychotics, however cases of NMS have been reported with the use of second generation antipsychotics like Olanzapine, Risperidone, Paliperidone, Aripiprazole, Ziprasidone, Amisulpride, Quetiapine and Clozapine, though the incidence of such reports is rare. Due to decreased use of first generation antipsychotics, NMS is reported less frequently now a days. In this case report- we highlight the management issues of a patient suffering from bipolar affective disorder, who had developed NMS following intramuscular injection of haloperidol, which was withdrawn and olanzapine was given later on. The patient had again developed NMS with olanzapine. Finally the patient was managed with modified electroconvulsive therapy and discharged on Lithium carbonate and Quetiapine.

  8. Introducing Preschool Children to Novel Fruits and Vegetables: A Pilot Study

    Tande, D. L.; Niemeier, B. S.; Hwang, J. H.; Stastny, S.; Bezbaruah, N.; Hektner, J. M.; Habedank, D.


    Purpose/Objectives: The purpose of this pilot study was to compare changes in preschool children's identification, preferences, and beliefs related to fruits and vegetables introduced to a child care center's menu before and after a nutrition education and food exposure intervention. The study also sought to determine how these changes were…

  9. A pilot study of flipped cardiopulmonary resuscitation training : Which items can be self-trained?

    Van Raemdonck, Veerle; Aerenhouts, Dirk; Monsieurs, Koen; De Martelaer, Kristine


    Objective: This study evaluated self-trained basic life support (BLS) skills acquired from an e-learning platform to design a complementary in-class training approach. Design: In total, 41 students (15–17 years, 29 men) participated in a pilot study on self-training in BLS. After 6 weeks, a

  10. Pilot Study of Community-Based Cognitive Behavioral Group Therapy for Adolescents with Social Phobia.

    Baer, Susan; Garland, E. Jane


    Objective: A pilot study to evaluate the efficacy of a cognitive-behavioral group therapy program for adolescents with social phobia, simplified both in terms of time and labor intensity from a previously studied program (Social Effectiveness Therapy for Children and Adolescents) to be more appropriate for a community outpatient psychiatric…

  11. Cellular Phone Use in Class: Implications for Teaching and Learning a Pilot Study

    Burns, Shari M.; Lohenry, Kevin


    Students equipped with the cell phones enter college classrooms daily. Realizing the impact of technology on fellow learners and faculty represents an area of concern. A pilot study was conducted to determine student and faculty perception regarding cellular phone use in the classroom. A quantitative descriptive study examined the perception of…

  12. A Pilot Study of Flipped Cardiopulmonary Resuscitation Training: Which Items Can Be Self-Trained?

    Van Raemdonck, Veerle; Aerenhouts, Dirk; Monsieurs, Koen; De Martelaer, Kristine


    Objective: This study evaluated self-trained basic life support (BLS) skills acquired from an e-learning platform to design a complementary in-class training approach. Design: In total, 41 students (15-17 years, 29 men) participated in a pilot study on self-training in BLS. After 6 weeks, a compression-only cardiopulmonary resuscitation (CPR) test…

  13. Engaging Struggling Early Readers to Promote Reading Success: A Pilot Study of Reading by Design

    Mendez, Linda M. Raffaele; Pelzmann, Catherine A.; Frank, Michael J.


    In this study, we piloted a Tier 2 intervention designed to improve reading skills among struggling early readers using an intervention that included SRA Reading Mastery, listening-while-reading activities, strategies to increase motivation and engagement in reading, and parent involvement in reading homework. The study included 6 students in…

  14. Parental Co-Viewing and Susceptibility for Smoking and Drinking in Adolescents: An Experimental Pilot Study

    Leeuw, R.N.H. de; Blom, H.C.; Engels, R.C.M.E.


    Background and Objectives: The current pilot study is the first experiment to examine whether parents are able to diminish the adverse influences of smoking and drinking depicted in movies through co-viewing. Methods: For this study, 99 adolescents (M - 12.82 years old; SD = .95; 38.8% boys) watched

  15. Measuring BDNF in saliva using commercial ELISA : Results from a small pilot study

    Vrijen, Charlotte; Schenk, Hendrika M.; Hartman, Catharina A.; Oldehinkel, Albertine J.

    Brain-derived neurotrophic factor (BDNF) is a protein often studied in psychiatric populations. Commercial ELISA kits have been validated for measuring BDNF in blood plasma and serum, but blood collection is an invasive method which cannot always be used. The aim of this pilot study was to explore

  16. Road surface erosion on the Jackson Demonstration State Forest: results of a pilot study

    Brian Barrett; Rosemary Kosaka; David. Tomberlin


    This paper presents results of a 3 year pilot study of surface erosion on forest roads in the Jackson Demonstration State Forest in California’s coastal redwood region. Ten road segments representing a range of surface, grade, and ditch conditions were selected for the study. At each segment, settling basins with tipping buckets were installed to measure...

  17. Developing Emotional Literacy through Individual Dance Movement Therapy: A Pilot Study

    Meekums, Bonnie


    This paper reports a pragmatic mixed methods pilot study of teacher perceptions regarding a school-based Dance Movement therapy (DMT) service for six children aged four to seven in a North of England primary school. No previous studies have systematically evaluated DMT in terms of the development of Emotional Literacy (EL), though theoretical…

  18. A Pilot Study of Motor Disturbances in Children with ADHD Belonging to Chilean Schools

    Ancatén González, Carlos; Montes, Rodrigo; Gutiérrez-Rojas, Cristian


    The present pilot study aimed to determine motor control alterations in children with ADHD belonging to public schools, using Da Fonseca's Psychomotor Battery (BPM). This was a descriptive cross-sectional comparative study. The sample consisted of two groups, each group composed of 15 children between 7 and 9 years old belonging to public…

  19. Brief Report: Prevalence of Pervasive Developmental Disorder in Brazil--A Pilot Study

    Paula, Cristiane S.; Ribeiro, Sabrina H.; Fombonne, Eric; Mercadante, Marcos T.


    This pilot study presents preliminary results concerning the prevalence of Pervasive Developmental Disorder (PDD) in South America. It was a three-phase study conducted in a typical town in Southeast Brazil. Case definition was based in a combination of standardized instruments and clinical evaluations by experts. The prevalence of PDD was…

  20. Managing Ethical Problems in Qualitative Research Involving Vulnerable Populations, Using a Pilot Study

    Evalina van Wijk RN, PhD


    Full Text Available The purpose of the researcher's study was to examine the meaning that intimate partners of female rape victims attached to their lived experiences after the rape. The conduct of qualitative research concerning non-offending partners of female rape victims, however, often involves multifaceted ethical and practical challenges, which can be managed through the use of pilot studies. The pilot study described in this report had three objectives. The first was to pretest and refine the proposed method for locating, accessing, and recruiting intimate partners of female rape victims, within the first two weeks after the rape, for participation in a six-month longitudinal study. The second objective was to identify and prevent all possible risk factors in the proposed recruitment and data collection methods that could harm the participants' safety during the main study. The third objective was to determine the feasibility of the main study, in terms of the limited financial and human resources available. The pilot phase was valuable in identifying ethical and methodological problems during the recruitment of participants and collection of data. It allowed for methodological adjustments prior to the main study and confirmed the feasibility of the overall research design. A pilot, pretesting phase is therefore seen as an essential component of a qualitative study involving a vulnerable population.

  1. Online Activities of Urban Malaysian Adolescents: Report of a Pilot Study

    Tan, Kok Eng; Yen Abdullah, Melissa Ng Lee; Guan Saw, Kim


    The literacy practices of many communities today show new ways of meaning making in the contemporary, technological and digital culture. A number of Malaysian adolescents belong to this culture. This pilot study reports the preliminary findings of a larger study aimed at describing the online activities of Malaysian adolescents. Fifty-four…

  2. A novel, online social cognitive training program for young adults with schizophrenia: A pilot study

    Mor Nahum


    Conclusion: This study provides an initial proof of concept for online social cognition training in schizophrenia. This form of training demonstrated feasibility and resulted in within-subject gains in social functioning and motivation. This pilot study represents a first step towards validating this training approach; randomized controlled trials, now underway, are designed to confirm and extend these findings.

  3. Balancing Direction and Independence in Second Language Vocabulary Learning: A Gesture Pilot Study

    Mathison, Lake


    This pilot study looks at the effect of learning second language vocabulary with gesture. Specifically, this current study asks whether researcher-instructed or student-constructed gestures are more effective. Depth of processing theories (Craik and Lockhart 1972) as well as more recent educational frameworks like ICAP ("Interactive,"…

  4. Principals Reflecting on Their Leadership Learning with an Heuristic: A Pilot Study

    Dempster, Neil; Fluckiger, Bev; Lovett, Susan


    The purpose of this paper is to report on a small pilot study in which an heuristic was used to enable principals to reflect on the confidence they have in their existing leadership knowledge and how they might add to that knowledge in the future. The motivation for the study arose from a literature review of strategies for leadership development…

  5. Emerging Literacy in Spanish among Hispanic Heritage Language University Students in the USA: A Pilot Study

    Fairclough, Marta; Belpoliti, Flavia


    This pilot study identifies some lexical aspects of the emerging writing skills in Spanish among receptive English/Spanish bilingual students with little or no exposure to formal study of the home language upon entering a Spanish Heritage Language Program at a large public university in the Southwestern United States. The 200+ essays analyzed in…

  6. 5-fluorocytosine-related bone-marrow depression and conversion to fluorouracil: a pilot study

    Vermes, András; Guchelaar, Henk-Jan; van Kuilenburg, Andre B. P.; Dankert, Jacob


    The aim of this study is to investigate whether fluorouracil (5-FU) could be responsible for bone-marrow depression occurring in fluorocytosine 5-FC) treated patients. Six 5-FC treated patients were included in this pilot study. Toxicity was monitored by means of thrombocyte and leucocyte counts.

  7. Teaching and Learning Simplification Strategies in a Philippine Classroom: A Pilot Study.

    Sibayan, Bonifacio P.; And Others

    This paper discusses the use of English as the main language of instruction in higher education in many developing nations, and reports on a pilot study of learning and teaching strategies used in Filipino- and English-language classrooms at De La Salle University in Manila, The Philippines. The study examined the "teacher talk" and…

  8. An in vitro analysis of disintegration times of different formulations of olanzapine orodispersible tablet: a preliminary report.

    Hobbs, David; Karagianis, Jamie; Treuer, Tamas; Raskin, Joel


    Orodispersible tablets (ODTs) are tablet or wafer forms of medication that disintegrate in the mouth, aided only by saliva. ODTs rely on different fast dissolve/disintegration manufacturing technologies. Disintegration time differences for several olanzapine ODT forms were investigated. Risperdal M-Tab(®) was included as a non-olanzapine ODT comparator. Eleven olanzapine ODT examples and orodispersible risperidone strengths were evaluated in vitro for formulation composition, manufacturing method, disintegration and dissolution characteristics, and formulation differences in comparison with freeze dried Zydis(®) ODT. Automated dissolution test equipment captured ODT dissolution rates by measuring real-time release of active ingredient. A high-speed video camera was used to capture tablet disintegration times in warm simulated saliva. The main outcome measure was the disintegration and dissolution characteristics of the ODT formulations. The ODT manufacturing method was associated with time to disintegrate; the fastest were freeze dried tablets, followed by soft compressed tablets and then hard/dense tablets. Olanzapine Zydis(®) was the only ODT that completely disintegrated in less than 4 s for all strengths (5, 10, 15, and 20 mg), followed by 5-mg Prolanz FAST(®) (12 s) and then risperidone ODT 4 mg (40 s). Reasons for slow dissolution of the olanzapine generics may include low product potency, excipient binding, excipient solubility, active ingredient particle size and incomplete disintegration. Differences in the formulation and manufacturing process of olanzapine ODTs appear to have a strong influence on the disintegration time of the active compound; differences that may potentially impact their use in clinical practice.

  9. Study on Combustion Oscillation of Premixed Flame with Pilot Fuel at Elevated Pressures

    Ohtsuka, Masaya; Yoshida, Shohei; Hirata, Yoshitaka; Kobayashi, Nariyoshi

    Acoustically-coupled combustion oscillation is studied for premixed flame with pilot fuel to be used in gas turbine combustors. Premixed gas is passed through swirl vanes and burnt with the centrally injected pilot fuel. The dependencies of pressure, fuel to air ratio, premixed fuel rate, inlet velocity and air temperature on the combustion oscillation are investigated. Two kinds of oscillation modes of ˜100Hz and ˜350Hz are activated according to inlet velocities. Fluctuating pressures are amplified when the premixed fuel rate is over ˜80% at elevated pressures. The fluctuating pressure peak moves to a higher premixed fuel ratio region with increased pressure or fuel to air ratio for the Helmholz type mode. Combustion oscillation occurs when the pilot fuel velocity is changed proportionally with the flame length.

  10. Efficacy of olanzapine in symptom relief and quality of life in gastric cancer patients receiving chemotherapy

    Novin Nikbakhsh


    Full Text Available Background: Considering the incidence and prevalence rates of gastric cancer in Mazandaran Province of Iran, this research was performed to evaluate the efficacy and safety of olanzapine in symptom relief and quality of life (QOL improvement of gastric patients receiving chemotherapy. Materials and Methods: This clinical trial was conducted on thirty new cases of gastric cancer patients whose treatment protocol was planned on chemotherapy and were allocated into two groups by simple random sampling. Intervention group (15 patients received olanzapine tablets (2.5–10 mg/day a day before the beginning of chemotherapy; in the 1st day of chemotherapy to 8 weeks after chemotherapy, besides the routine treatment regimens. The control group received only the routine treatment regimens. The patients were followed for 8 weeks after intervention. All of the patients were assessed with Hospital Anxiety and Depression Scale (HADS and WHO-QOL-BREF questionnaires; further, Rhodes index was used to evaluate nausea and vomiting (N/V status. Results: All the recruited patients continued the allocated interventions (no lost to follow-up. N/V decreased in the case group, but the difference was not statistically significant (P = 0.438. The patients' appetite and body mass index increased (P = 0.006. Anxiety and depression subscales of HADS had significant differences between the two groups (P 0.05. No significant increase was observed in fasting and 2-h postprandial blood glucose and lipid profile (P > 0.05. Conclusion: Olanzapine can be considered as an effective drug to increase appetite and decrease anxiety and depression in patients with gastric cancer.

  11. Voluntariness of consent to HIV clinical research: A conceptual and empirical pilot study.

    Mamotte, Nicole; Wassenaar, Douglas


    Obtaining voluntary informed consent for research participation is an ethical imperative, yet there appears to be little consensus regarding what constitutes a voluntary consent decision. An instrument to assess influences on participants' consent decision and perceived voluntariness was developed and piloted in two South African HIV clinical trials. The pilot study found high levels of perceived voluntariness. The feeling of having no choice but to participate was significantly associated with lower perceived voluntariness. Overall the data suggest that it is possible to obtain voluntary and valid consent for research participants in ethically complex HIV clinical trials in a developing country context.

  12. Scaling the quality of clinical audit projects: a pilot study.

    Millard, A D


    To pilot the development of a scale measuring the quality of audit projects through audit project reports. Statements about clinical audit projects were selected from existing instruments, assessing the quality of clinical audit projects, to form a Likert scale. The audit facilitators were based in Scottish health boards and trusts. The participants were audit facilitators known to have over 2 years experience of supporting clinical audit. The response at first test was 11 out of 14 and at the second test it was 27 out of 46. The draft scale was tested by 27 audit facilitators who expressed their strength of agreement or disagreement with each statement for three reports. Validity was assessed by test-re-test, item-total, and total-global indicator correlations. Of the 20 statements, 15 had satisfactory correlations with scale totals. Scale totals had good correlations with global indicators. Test-re-test correlation was modest. The wide range of responses means further research is needed to measure the consistency of audit facilitators' interpretations, perhaps comparing a trained group with an untrained group. There may be a need for a separate scale for reaudits. Educational impact is distinct from project impact generally. It may be more meaningful to treat the selection of projects and aims, methodology and impact separately as subscales and take a project profiling approach rather than attempting to produce a global quality index.

  13. A pilot study to evaluate runoff quantity from green roofs.

    Lee, Ju Young; Lee, Min Jung; Han, Mooyoung


    The use of green roofs is gaining increased recognition in many countries as a solution that can be used to improve environmental quality and reduce runoff quantity. To achieve these goals, pilot-scale green roof assemblies have been constructed and operated in an urban setting. From a stormwater management perspective, green roofs are 42.8-60.8% effective in reducing runoff for 200 mm soil depth and 13.8-34.4% effective in reducing runoff for 150 mm soil depth. By using Spearman rank correlation analysis, high rainfall intensity was shown to have a negative relationship with delayed occurrence time, demonstrating that the soil media in green roofs do not efficiently retain rainwater. Increasing the number of antecedent dry days can help to improve water retention capacity and delay occurrence time. From the viewpoint of runoff water quality, green roofs are regarded as the best management practice by filtration and adsorption through growth media (soil). Copyright © 2015 Elsevier Ltd. All rights reserved.

  14. Fertility after intrauterine device removal: a pilot study.

    Stoddard, Amy M; Xu, Hanna; Madden, Tessa; Allsworth, Jenifer E; Peipert, Jeffrey F


    Despite high efficacy, only 7.7% of women in the United States currently using contraception use an IUD. There is little published contemporary data about fertility rates after IUD use, especially in nulliparous women and women using the hormonal IUD. We recruited sexually active women 18 to 35 years of age enrolled in the Contraceptive CHOICE Project who had discontinued a contraceptive method and desired pregnancy. In this pilot project, we enrolled 69 former IUD users (19 copper and 50 levonorgestrel) and 42 former non-IUD users. Pregnancy rates at 12 months were similar between the two groups; 81% of IUD users became pregnant compared to 70% of non-IUD users (p = 0.18). In the Cox model, there was no difference in the time to pregnancy in IUD users compared to non-IUD users (HRadj 1.19, 95% CI 0.74-1.92). African American race was the only variable associated with reduced fertility (HRadj 0.40, 95% CI 0.24-0.67). We found no difference in 12-month pregnancy rates or time to pregnancy between former IUD users and users of other contraceptive methods. However, there was a clinically and statistically significant reduction in fertility in African American women.

  15. Pulsed Electromagnetic Field Assisted in vitro Electroporation: A Pilot Study

    Novickij, Vitalij; Grainys, Audrius; Lastauskienė, Eglė; Kananavičiūtė, Rūta; Pamedytytė, Dovilė; Kalėdienė, Lilija; Novickij, Jurij; Miklavčič, Damijan


    Electroporation is a phenomenon occurring due to exposure of cells to Pulsed Electric Fields (PEF) which leads to increase of membrane permeability. Electroporation is used in medicine, biotechnology, and food processing. Recently, as an alternative to electroporation by PEF, Pulsed ElectroMagnetic Fields (PEMF) application causing similar biological effects was suggested. Since induced electric field in PEMF however is 2-3 magnitudes lower than in PEF electroporation, the membrane permeabilization mechanism remains hypothetical. We have designed pilot experiments where Saccharomyces cerevisiae and Candida lusitaniae cells were subjected to single 100-250 μs electrical pulse of 800 V with and without concomitant delivery of magnetic pulse (3, 6 and 9 T). As expected, after the PEF pulses only the number of Propidium Iodide (PI) fluorescent cells has increased, indicative of membrane permeabilization. We further show that single sub-millisecond magnetic field pulse did not cause detectable poration of yeast. Concomitant exposure of cells to pulsed electric (PEF) and magnetic field (PMF) however resulted in the increased number PI fluorescent cells and reduced viability. Our results show increased membrane permeability by PEF when combined with magnetic field pulse, which can explain electroporation at considerably lower electric field strengths induced by PEMF compared to classical electroporation.

  16. Genetic screening in the Persian Jewish community: A pilot study.

    Kaback, Michael; Lopatequi, Jean; Portuges, Amin Riley; Quindipan, Cathy; Pariani, Mitchel; Salimpour-Davidov, Nilou; Rimoin, David L


    Israeli investigators have identified several relatively frequent disorders due to founder point mutations in Persian (Iranian) Jews, who, for nearly three centuries up to the Islamic Revolution of 1979, were completely isolated reproductively. Using a community-based model previously employed with Tay-Sachs disease prevention, we developed a pilot program for the Persian Jewish community of greater Los Angeles. We screened for mutations responsible for four relatively frequent autosomal recessive conditions in Persian Jews in which effective interventions are available for each: Pseudocholinesterase deficiency (butyryl cholinesterase deficiency); Congenital hypoaldosteronism (corticosterone methyl oxidase II); Autoimmune polyendocrinopathy (autoimmune regulatory element); and Hereditary Inclusion Body myopathy. One thousand individuals volunteered. Mutations were assessed in saliva-derived DNA and were positive for 121/1000 butyryl cholinesterase deficiency; 92/1000 Hereditary Inclusion Body myopathy; 38/1000 corticosterone methyl oxidase II; and 37/1000 autoimmune regulatory element. Ten homozygous individuals (9 butyryl cholinesterase deficiency and 1 Hereditary Inclusion Body myopathy) and 10 "at-risk" couples (seven for butyryl cholinesterase deficiency and one each for the other three disorders) were identified. These frequencies are comparable with those in Israel and indicate an extraordinary level of inbreeding, as anticipated. A carefully planned effort can be delivered to an "increased risk" community if detailed attention is given to planning and organization. However, availability of an effective intervention for those found to be "at-risk" or possibly affected, is essential before embarking.

  17. Use of a Data-Linked Weather Information Display and Effects on Pilot Navigation Decision Making in a Piloted Simulation Study

    Yuchnovicz, Daniel E.; Novacek, Paul F.; Burgess, Malcolm A.; Heck, Michael L.; Stokes, Alan F.


    This study provides recommendations to the FAA and to prospective manufacturers based on an exploration of the effects of data link weather displays upon pilot decision performance. An experiment was conducted with twenty-four current instrument rated pilots who were divided into two equal groups and presented with a challenging but realistic flight scenario involving weather containing significant embedded convective activity. All flights were flown in a full-mission simulation facility within instrument meteorological conditions. The inflight weather display depicted NexRad images, graphical METARs and textual METARs. The objective was to investigate the potential for misuse of a weather display, and incorporate recommendations for the design and use of these displays. The primary conclusion of the study found that the inflight weather display did not improve weather avoidance decision making. Some of the reasons to support this finding include: the pilot's inability to easily perceive their proximity to the storms, increased workload and difficulty in deciphering METAR textual data. The compelling nature of a graphical weather display caused many pilots to reduce their reliance on corroborating weather information from other sources. Minor changes to the weather display could improve the ability of a pilot to make better decisions on hazard avoidance.

  18. Mesoporous hydroxyapatite as a carrier of olanzapine for long-acting antidepression treatment in rats with induced depression.

    Shyong, Yan-Jye; Wang, Mao-Hsien; Kuo, Li-Wei; Su, Chang-Fu; Kuo, Wei-Ting; Chang, Kuo-Chi; Lin, Feng-Huei


    An antidepressant carrier, mesoporous hydroxyapatite olanzapine (mesoHAP-OLZ), was designed to maintain 3weeks of constant medication release. The carrier was intramuscularly (IM) injected, where cellular activity played a role in achieving the goal of constant release. The efficiency of the treatment was evaluated from 3 perspectives in in vivo studies: locomotor activities, biomarkers, and learning and memory ability. MesoHAP-OLZ can increase the locomotor activity in rats with induced depression determined by open field test (OFT) and forced swim test (FST). Serotonin (5-HT), one of the most important biomarker in depression can also be increased by mesoHAP-OLZ, leading to increased hippocampus activity as measured by functional magnetic resonance imaging (fMRI). MesoHAP-OLZ can also improve learning and memory ability in rats with induced depression during Morris water maze (MWM) test. Our findings further show that mesoHAP-OLZ can provide long-term drug release with a single IM injection, helping to solve the problem of non-adherent medication intake that often occurs in antidepressant therapy. Copyright © 2017 Elsevier B.V. All rights reserved.

  19. Application of a ketogenic diet in children with autistic behavior: pilot study.

    Evangeliou, A.; Vlachonikolis, I.; Mihailidou, H.; Spilioti, M.; Skarpalezou, A.; Makaronas, N.; Prokopiou, A.; Christodoulou, P.; Liapi-Adamidou, G.; Helidonis, E.; Sbyrakis, S.; Smeitink, J.A.M.


    A pilot prospective follow-up study of the role of the ketogenic diet was carried out on 30 children, aged between 4 and 10 years, with autistic behavior. The diet was applied for 6 months, with continuous administration for 4 weeks, interrupted by 2-week diet-free intervals. Seven patients could

  20. A Pilot Study Applying Social Cognitive Theory to Predict HPV Vaccination Intentions of Unvaccinated College Women

    Catalano, Hannah Priest; Knowlden, Adam P.; Sharma, Manoj; Franzidis, Alexia


    Although college-aged women are at high risk for human papillomavirus (HPV) infection, many college women remain unvaccinated against HPV. Testing health behavior theory can assist sexuality educators in identifying behavioral antecedents to promote behavior change within an intervention. The purpose of this pilot study was to utilize social…

  1. A Pilot Study of Problems and Practices in the Induction of Beginning Teachers.

    Bouchard, John B.; Hull, Ronald E.

    A pilot study was designed to test the practicality of gathering data through interviews and to provide tentative information on induction problems and practices encountered by beginning teachers in the Cattaraugus-Chautauqua County area of New York. Fifty-three elementary self-contained classroom teachers and secondary academic subject-matter…

  2. Pilot Testing for Feasibility in a Study of Student Retention and Attrition in Online Undergraduate Programs

    Fraser, Joy; Fahlman, Dorothy; Arscott, Jane; Guillot, Isabelle


    Prior to undertaking a descriptive study on attrition and retention of students in two online undergraduate health administration and human service programs, a pilot test was conducted to assess the procedures for participant recruitment, usability of the survey questionnaire, and data collection processes. A retention model provided the…

  3. Using CALMERSS to Enhance Teacher Well-Being: A Pilot Study

    Taylor, Mark J.


    Prior research has shown that cognitive behavioural therapy, relaxation, mindfulness, exercise and positive psychology interventions, when conducted as single interventions, have a useful effect on depression and also increasing well-being. The purpose of this study was to conduct a pilot programme to determine the efficacy of a multi-modal…

  4. The Effects of Modified Melodic Intonation Therapy on Nonfluent Aphasia: A Pilot Study

    Conklyn, Dwyer; Novak, Eric; Boissy, Adrienne; Bethoux, Francois; Chemali, Kamal


    Objective: Positive results have been reported with melodic intonation therapy (MIT) in nonfluent aphasia patients with damage to their left-brain speech processes, using the patient's intact ability to sing to promote functional language. This pilot study sought to determine the immediate effects of introducing modified melodic intonation therapy…

  5. Patterns of feelings in face to face negotiation: a Sino-Dutch pilot study

    Ulijn, J.M.; Rutkowski, A.F.; Kumar, Rajesh; Zhu, Y.


    We conducted a pilot study to compare the emotions experienced by Dutch and Chinese students during a face-to-face negotiation role play. Emotions play an important role in negotiations because they influence the behaviour and judgments of negotiators The Data Printer case developed by Greenhalgh

  6. The SunWise Policy Intervention for School-Based Sun Protection: A Pilot Study

    Emmons, Karen M.; Geller, Alan C.; Viswanath, Vish; Rutsch, Linda; Zwirn, Jodie; Gorham, Sue; Puleo, Elaine


    Skin cancer is highly preventable, but clearly there is a critical need to focus on better ways to disseminate information about known skin cancer prevention. The U.S. Environmental Protection Agency's (EPA) SunWise Program is one channel for reaching children, teachers, and school nurses. In a pilot study designed to increase adoption of…

  7. Practical and Scholarly Implications of Information Behaviour Research: A Pilot Study of Research Literature

    Koh, Kyungwon; Rubenstein, Ellen; White, Kelvin


    Introduction: This pilot study examined how current information behaviour research addresses the implications and potential impacts of its findings. The goal was to understand what implications and contributions the field has made and how effectively authors communicate implications of their findings. Methods: We conducted a content analysis of 30…

  8. A five-day inpatient EMDR treatment programme for PTSD: pilot study

    Zepeda Méndez, Mayaris; Nijdam, Mirjam J.; ter Heide, F. Jackie June; van der Aa, Niels; Olff, Miranda


    Conclusions: The majority of patients in our pilot study experienced symptom reduction consistent with reliable changes in this five-day inpatient treatment with EMDR and yoga. Randomized controlled trials - with longer follow up periods - are needed to properly determine efficacy and efficiency of

  9. The Effects of Sensory Processing and Behavior of Toddlers on Parent Participation: A Pilot Study

    DaLomba, Elaina; Baxter, Mary Frances; Fingerhut, Patricia; O'Donnell, Anne


    Occupational therapists treat children with sensory processing and behavioral concerns, however, little information exists on how these issues affect parent participation. This pilot study examined the sensory processing and behaviors of toddlers with developmental delays and correlated these with parents' perceived ability to participate in…

  10. Social and Emotional Education with Australian Year 7 and 8 Middle School Students: A Pilot Study

    Midford, Richard; Cahill, Helen; Geng, Gretchen; Leckning, Bernard; Robinson, Gary; Te Ava, Aue


    Objective: This pilot study sought to better understand what can be achieved by an evidence-based classroom social and emotional education programme. Design and Methods: A 10-lesson, classroom-based programme that taught about emotional literacy, personal strengths, coping and problem-solving strategies, stress management, emotional regulation and…

  11. A Pilot Study of a Kindergarten Summer School Reading Program in High-Poverty Urban Schools

    Denton, Carolyn A.; Solari, Emily J.; Ciancio, Dennis J.; Hecht, Steven A.; Swank, Paul R.


    This pilot study examined an implementation of a kindergarten summer school reading program in 4 high-poverty urban schools. The program targeted both basic reading skills and oral language development. Students were randomly assigned to a treatment group (n = 25) or a typical practice comparison group (n = 28) within each school; however,…

  12. Behavioral determinants of play in a stag-hunt coordination game – a pilot study

    Maciej Kos


    Full Text Available The aim of this pilot study is to investigate relationships between various riskattitude measures and players’ behavior in the first-round of a repeated stag hunt game. This research report presents preliminary findings that the first-round behavior cannot be explained by any of the commonly used risk-elicitation instruments and describes relationships between those instruments.

  13. Gaming and conventional exercises for improvement of arm function after stroke: a randomised controlled pilot study

    Kottink, A.I.R.; Prange, Grada Berendina; Krabben, T.; Rietman, Johan Swanik; Buurke, Jaap


    Objective: The use of new technologies in rehabilitation, such as virtual reality and/or computerized gaming exercises, may be useful to enable patients to practice intensively in a motivating way. The objective of the present randomized controlled pilot study was to compare the effect of reach

  14. How Newspaper Advertising Sales Managers Spend Their Time: A Pilot Study.

    Hudson, Jerry C.; Saathoff, Roger C.

    A pilot study examined how newspaper advertising sales managers in five southwestern states spend their time during a typical work day. Of the 360 questionnaires mailed, 176 responses were received. The largest number of responses (93) came from retail sales managers of newspapers in markets with less than 50,000 population. The questionnaire…

  15. Fear of Negative Evaluation Influences Eye Gaze in Adolescents with Autism Spectrum Disorder: A Pilot Study

    White, Susan W.; Maddox, Brenna B.; Panneton, Robin K.


    Social anxiety is common among adolescents with Autism Spectrum Disorder (ASD). In this modest-sized pilot study, we examined the relationship between social worries and gaze patterns to static social stimuli in adolescents with ASD (n = 15) and gender-matched adolescents without ASD (control; n = 18). Among cognitively unimpaired adolescents with…

  16. The Internet as a Source of Academic Research Information: Findings of Two Pilot Studies.

    Kibirige, Harry M.; DePalo, Lisa


    Discussion of information available on the Internet focuses on two pilot studies that investigated how academic users perceive search engines and subject-oriented databases as sources of topical information. Highlights include information seeking behavior of academic users; undergraduate users; graduate users; faculty; and implications for…

  17. Illuminating the "Boy Problem" from Children's and Teachers' Perspectives: A Pilot Study

    Hamilton, Paula Louise; Jones, Louise


    The apparent educational underperformance of boys has received phenomenal attention worldwide for many years. In the UK, it has led to various government reports and policies aimed at raising boys' achievement. This small-scale qualitative-interpretive pilot study, undertaken in one urban primary school in North Wales, reports the findings from…

  18. Effectiveness of neuromotor task training for children with developmental coordination disorder : a pilot study

    Schoemaker, M.M.; Niemeijer, A.S.; Reynders, K.; Smits-Engelsman, B.C.


    The aim of this pilot study was to evaluate the effectiveness of a Neuromotor Task Training (NTT), recently developed for the treatment of children with Developmental Coordination Disorder (DCD) by pediatric physical therapists in the Netherlands. NTT is a task-oriented treatment program based upon

  19. Multilingual and Multicultural Task-Based Learning Scenarios: A Pilot Study from the MAGICC Project

    Álvarez, Inma; Pérez-Cavana, María Luisa


    In this article we report on the results of a pilot study on the use of task-based multilingual and multicultural professional scenarios for higher education teachers and learners at BA and MA level. The scenarios reflect new learning outcomes and assessment criteria for the presently under-conceptualised domain of communication in multilingual…

  20. Excessive Use of Massively Multi-Player Online Role-Playing Games: A Pilot Study

    Hussain, Zaheer; Griffiths, Mark D.


    Massively multiplayer online role-playing games (MMORPGs) are one of the most interesting innovations in the area of online computer gaming. This pilot study set out to examine the psychological and social effects of online gaming using an online questionnaire with particular reference to excessive and "dependent" online gaming. A self-selecting…