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Sample records for predicts clinical efficacy

  1. Endovascular Treatment of Malignant Superior Vena Cava Syndrome: Results and Predictive Factors of Clinical Efficacy

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    Fagedet, Dorothee, E-mail: DFagedet@chu-grenoble.fr [CHU de Grenoble, Clinique universitaire de medecine interne, Pole Pluridisciplinaire de Medecine (France); Thony, Frederic, E-mail: FThony@chu-grenoble.fr [CHU de Grenoble, Clinique universitaire de radiologie et imagerie medicale, Pole d' Imagerie (France); Timsit, Jean-Francois, E-mail: JFTimsit@chu-grenoble.fr [CHU de Grenoble, Clinique universitaire de reanimation, Pole Medecine Aiguee Communautaire (France); Rodiere, Mathieu, E-mail: MRodiere@chu-grenoble.fr [CHU de Grenoble, Clinique universitaire de radiologie et imagerie medicale, Pole d' Imagerie (France); Monnin-Bares, Valerie, E-mail: v-monnin@chu-montpellier.fr [CHRU Arnaud de Villeneuve, Imagerie Medicale Thoracique Cardiovasculaire (France); Ferretti, Gilbert R., E-mail: GFerretti@chu-grenoble.fr [CHU de Grenoble, Clinique universitaire de radiologie et imagerie medicale, Pole d' Imagerie (France); Vesin, Aurelien; Moro-Sibilot, Denis, E-mail: DMoro.pneumo@chu-grenoble.fr [University Grenoble 1 e Albert Bonniot Institute, Inserm U823 (France)

    2013-02-15

    To demonstrate the effectiveness of endovascular treatment (EVT) with self-expandable bare stents for malignant superior vena cava syndrome (SVCS) and to analyze predictive factors of EVT efficacy. Retrospective review of the 164 patients with malignant SVCS treated with EVT in our hospital from August 1992 to December 2007 and followed until February 2009. Endovascular treatment includes angioplasty before and after stent placement. We used self-expandable bare stents. We studied results of this treatment and looked for predictive factors of clinical efficacy, recurrence, and complications by statistical analysis. Endovascular treatment was clinically successful in 95% of cases, with an acceptable rate of early mortality (2.4%). Thrombosis of the superior vena cava was the only independent factor for EVT failure. The use of stents over 16 mm in diameter was a predictive factor for complications (P = 0.008). Twenty-one complications (12.8%) occurred during the follow-up period. Relapse occurred in 36 patients (21.9%), with effective restenting in 75% of cases. Recurrence of SVCS was significantly increased in cases of occlusion (P = 0.01), initial associated thrombosis (P = 0.006), or use of steel stents (P = 0.004). Long-term anticoagulant therapy did not influence the risk of recurrence or complications. In malignancy, EVT with self-expandable bare stents is an effective SVCS therapy. These results prompt us to propose treatment with stents earlier in the clinical course of patients with SVCS and to avoid dilatation greater than 16 mm.

  2. Endovascular Treatment of Malignant Superior Vena Cava Syndrome: Results and Predictive Factors of Clinical Efficacy

    International Nuclear Information System (INIS)

    Fagedet, Dorothée; Thony, Frederic; Timsit, Jean-François; Rodiere, Mathieu; Monnin-Bares, Valérie; Ferretti, Gilbert R.; Vesin, Aurélien; Moro-Sibilot, Denis

    2013-01-01

    To demonstrate the effectiveness of endovascular treatment (EVT) with self-expandable bare stents for malignant superior vena cava syndrome (SVCS) and to analyze predictive factors of EVT efficacy. Retrospective review of the 164 patients with malignant SVCS treated with EVT in our hospital from August 1992 to December 2007 and followed until February 2009. Endovascular treatment includes angioplasty before and after stent placement. We used self-expandable bare stents. We studied results of this treatment and looked for predictive factors of clinical efficacy, recurrence, and complications by statistical analysis. Endovascular treatment was clinically successful in 95% of cases, with an acceptable rate of early mortality (2.4%). Thrombosis of the superior vena cava was the only independent factor for EVT failure. The use of stents over 16 mm in diameter was a predictive factor for complications (P = 0.008). Twenty-one complications (12.8%) occurred during the follow-up period. Relapse occurred in 36 patients (21.9%), with effective restenting in 75% of cases. Recurrence of SVCS was significantly increased in cases of occlusion (P = 0.01), initial associated thrombosis (P = 0.006), or use of steel stents (P = 0.004). Long-term anticoagulant therapy did not influence the risk of recurrence or complications. In malignancy, EVT with self-expandable bare stents is an effective SVCS therapy. These results prompt us to propose treatment with stents earlier in the clinical course of patients with SVCS and to avoid dilatation greater than 16 mm.

  3. Efficacy and predictive value of clinical stage in non-surgical patients with esophageal cancer

    International Nuclear Information System (INIS)

    Liu Xiao; Wang Guiqi; He Shun

    2014-01-01

    Objective: To investigate the efficacy and predictive value of clinical stage in non-surgical patients with esophageal cancer (EC). Methods: A retrospective study was conducted in 358 EC patients who underwent radical surgery in our hospital from April 2003 to October 2010 and who had preoperative work-up including endoscopic esophageal ultrasound (EUS), esophagoscopy, thoracic CT scans,and contrast esophagography and had detailed information on postoperative pathological stages. The predictive value of preoperative clinical T/N stage based on EUS + CT for postoperative pathological stage was analyzed. The disease free survival (DFS) and overall survival (OS) were analyzed according to the UICC TNM classification (2002/ 2009) and the clinical stage based on imaging findings. Results: The median follow-up was 47 months.A total of 305 (85.2%) of all patients were analyzed by clinical stage based on EUS + CT.Among them, the predictive value of clinical T stage for pathological T stage was 0-88.6%, highest (88.6%) for T1 stage and lowest for T4 stage. The predictive value of clinical N stage (N 0 /N1) was 62.5-100%. The significant differences in OS and DFS rates based on both 2002 and 2009 UICC TNM classifications were noted (P=0.000 and 0.000). There were significant differences in OS between stage groups, except the comparison between two stage Ⅳ patients and other groups, according to 2002 UICC TNM classification. There were usually insignificant differences in OS between stage groups, according to 2009 UICC TNM classification. For the 305 patients staged clinically based on EUS and CT according to 2002 UICC TNM classification, significant differences in OS and DFS rates were noted (P=0.000 and 0.000). Conclusions: Imaging modalities show good predictive value for N stage (N0/N1),even though they cannot accurately provide the number of metastatic lymph nodes. The clinical stage based on EUS + CT can effectively predict the prognosis of non-surgical EC patients

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

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    Jin-Sun Chang

    2013-02-01

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

  5. Efficacy Coefficients Determined Using Nail Permeability and Antifungal Activity in Keratin-Containing Media Are Useful for Predicting Clinical Efficacies of Topical Drugs for Onychomycosis.

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    Yoshiki Matsuda

    Full Text Available Onychomycosis is difficult to treat topically due to the deep location of the infection under the densely keratinized nail plate. In order to obtain an in vitro index that is relevant to the clinical efficacy of topical anti-onychomycosis drugs, we profiled five topical drugs: amorolfine, ciclopirox, efinaconazole, luliconazole, and terbinafine, for their nail permeabilities, keratin affinities, and anti-dermatophytic activities in the presence of keratin. Efinaconazole and ciclopirox permeated full-thickness human nails more deeply than luliconazole. Amorolfine and terbinafine did not show any detectable permeation. The free-drug concentration of efinaconazole in a 5% human nail keratin suspension was 24.9%, which was significantly higher than those of the other drugs (1.1-3.9%. Additionally, efinaconazole was released from human nail keratin at a greater proportion than the other drugs. The MICs of the five drugs for Trichophyton rubrum were determined at various concentrations of keratin (0-20% in RPMI 1640 medium. The MICs of ciclopirox were not affected by keratin, whereas those of efinaconazole were slightly increased and those of luliconazole and terbinafine were markedly increased in the presence of 20% keratin. Efficacy coefficients were calculated using the nail permeation flux and MIC in media without or with keratin. Efinaconazole showed the highest efficacy coefficient, which was determined using MIC in media with keratin. The order of efficacy coefficients determined using MIC in keratin-containing media rather than keratin-free media was consistent with that of complete cure rates in previously reported clinical trials. The present study revealed that efficacy coefficients determined using MIC in keratin-containing media are useful for predicting the clinical efficacies of topical drugs. In order to be more effective, topical drugs have to possess higher efficacy coefficients.

  6. The role of religiosity, coping strategies, self-efficacy and personality dimensions in the prediction of Iranian undergraduate rehabilitation interns' satisfaction with their clinical experience.

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    Mirsaleh, Y R; Rezai, H; Kivi, S R; Ghorbani, R

    2010-12-01

    to investigate the relationship between religiosity, coping styles, self-efficacy and personality dimensions as predictors of satisfaction with clinical experience in rehabilitation interns during transition from academic study to clinical internship. a cross-sectional survey design. five rehabilitation faculties. three hundred and eighteen undergraduate rehabilitation interns, including physical therapy, occupational therapy and speech and language pathology students. Islamic Religiosity Scale, Ways of Coping Questionnaire, General Self-efficacy Scale, NEO Five Factor Inventory, and Satisfaction with Clinical Experiences Questionnaire. religiosity, problem-focused coping and general self-efficacy had significant positive correlation with satisfaction with clinical internship in rehabilitation students. Among personality dimensions, openness, agreement and consciousness had significant positive correlation with satisfaction with clinical experience and neuroticism had significant negative correlation with satisfaction with clinical experience. The results of regression analysis demonstrated that religiosity and self-efficacy had important roles in the prediction of satisfaction with clinical experience in all the rehabilitation intern students of three disciplines (physical therapy, occupational therapy, and speech and language pathology). religiosity, problem-focused coping and general self-efficacy seem to be good predictors of satisfaction with clinical internship in rehabilitation students.

  7. Z-LASIK and Trans-PRK for correction of high-grade myopia: safety, efficacy, predictability and clinical outcomes.

    Science.gov (United States)

    Gershoni, Assaf; Mimouni, Michael; Livny, Eitan; Bahar, Irit

    2018-03-12

    The aim of the study was to examine the outcomes of transepithelial photorefractive keratectomy (Trans-PRK) and Femtosecond Laser-assisted in situ keratomileusis (Z-LASIK) for the correction of high myopia. A retrospective cohort study design was used. The study group included 792 eyes with high-grade myopia (- 6.0 diopters or higher) or high-grade myopia with astigmatism that were treated with Z-LASIK or Trans-PRK in 2013 through 2014 in an optical outpatient clinic of a large private medical service. The Trans-PRK group comprised of 674 eyes with a spherical equivalent (SE) of - 7.87 ± 1.46 and the Z-LASIK group comprised of 118 eyes with a SE of - 7.19 ± 0.81 (P PRK group was - 0.06 and - 0.02 in the Z-LASIK group (P = 0.545). Efficacy index values were 0.92 in the Trans-PRK group and 0.95 in the Z-LASIK group (P = 0.083), and corresponding safety index values were 0.95 and 0.97 (P = 0.056). An UCVA of 20/40 or better was achieved in 94.20% of eyes in the Trans-PRK group, and 98.31% in the Z-LASIK group (P = 0.063). The majority of eyes in both the Trans-PRK and Z-LASIK groups were within ± 0.5D of attempted correction: 59.35 and 64.71%, respectively (P = 0.271). Both Trans-PRK and Z-LASIK demonstrated excellent efficacy, safety and predictability profiles, with results comparable and in some cases superior to the current literature. Results of Z-LASIK were slightly better than those of Trans-PRK, though the preoperative SE of the latter was higher.

  8. The Cynomolgus Macaque Natural History Model of Pneumonic Tularemia for Predicting Clinical Efficacy Under the Animal Rule

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    Guina, Tina; Lanning, Lynda L.; Omland, Kristian S.; Williams, Mark S.; Wolfraim, Larry A.; Heyse, Stephen P.; Houchens, Christopher R.; Sanz, Patrick; Hewitt, Judith A.

    2018-01-01

    Francisella tularensis is a highly infectious Gram-negative bacterium that is the etiologic agent of tularemia in animals and humans and a Tier 1 select agent. The natural incidence of pneumonic tularemia worldwide is very low; therefore, it is not feasible to conduct clinical efficacy testing of tularemia medical countermeasures (MCM) in human populations. Development and licensure of tularemia therapeutics and vaccines need to occur under the Food and Drug Administration's (FDA's) Animal Rule under which efficacy studies are conducted in well-characterized animal models that reflect the pathophysiology of human disease. The Tularemia Animal Model Qualification (AMQ) Working Group is seeking qualification of the cynomolgus macaque (Macaca fascicularis) model of pneumonic tularemia under Drug Development Tools Qualification Programs with the FDA based upon the results of studies described in this manuscript. Analysis of data on survival, average time to death, average time to fever onset, average interval between fever and death, and bacteremia; together with summaries of clinical signs, necropsy findings, and histopathology from the animals exposed to aerosolized F. tularensis Schu S4 in five natural history studies and one antibiotic efficacy study form the basis for the proposed cynomolgus macaque model. Results support the conclusion that signs of pneumonic tularemia in cynomolgus macaques exposed to 300–3,000 colony forming units (cfu) aerosolized F. tularensis Schu S4, under the conditions described herein, and human pneumonic tularemia cases are highly similar. Animal age, weight, and sex of animals challenged with 300–3,000 cfu Schu S4 did not impact fever onset in studies described herein. This study summarizes critical parameters and endpoints of a well-characterized cynomolgus macaque model of pneumonic tularemia and demonstrates this model is appropriate for qualification, and for testing efficacy of tularemia therapeutics under Animal Rule. PMID

  9. Four-hour quantitative real-time polymerase chain reaction-based comprehensive chromosome screening and accumulating evidence of accuracy, safety, predictive value, and clinical efficacy.

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    Treff, Nathan R; Scott, Richard T

    2013-03-15

    Embryonic comprehensive chromosomal euploidy may represent a powerful biomarker to improve the success of IVF. However, there are a number of aneuploidy screening strategies to consider, including different technologic platforms with which to interrogate the embryonic DNA, and different embryonic developmental stages from which DNA can be analyzed. Although there are advantages and disadvantages associated with each strategy, a series of experiments producing evidence of accuracy, safety, clinical predictive value, and clinical efficacy indicate that trophectoderm biopsy and quantitative real-time polymerase chain reaction (qPCR)-based comprehensive chromosome screening (CCS) may represent a useful strategy to improve the success of IVF. This Biomarkers in Reproductive Medicine special issue review summarizes the accumulated experience with the development and clinical application of a 4-hour blastocyst qPCR-based CCS technology. Copyright © 2013 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  10. Conditioned pain modulation predicts duloxetine efficacy in painful diabetic neuropathy.

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    Yarnitsky, David; Granot, Michal; Nahman-Averbuch, Hadas; Khamaisi, Mogher; Granovsky, Yelena

    2012-06-01

    This study aims to individualize the selection of drugs for neuropathic pain by examining the potential coupling of a given drug's mechanism of action with the patient's pain modulation pattern. The latter is assessed by the conditioned pain modulation (CPM) and temporal summation (TS) protocols. We hypothesized that patients with a malfunctioning pain modulation pattern, such as less efficient CPM, would benefit more from drugs augmenting descending inhibitory pain control than would patients with a normal modulation pattern of efficient CPM. Thirty patients with painful diabetic neuropathy received 1 week of placebo, 1 week of 30 mg/d duloxetine, and 4 weeks of 60 mg/d duloxetine. Pain modulation was assessed psychophysically, both before and at the end of treatment. Patient assessment of drug efficacy, assessed weekly, was the study's primary outcome. Baseline CPM was found to be correlated with duloxetine efficacy (r=0.628, P<.001, efficient CPM is marked negative), such that less efficient CPM predicted efficacious use of duloxetine. Regression analysis (R(2)=0.673; P=.012) showed that drug efficacy was predicted only by CPM (P=.001) and not by pretreatment pain levels, neuropathy severity, depression level, or patient assessment of improvement by placebo. Furthermore, beyond its predictive value, the treatment-induced improvement in CPM was correlated with drug efficacy (r=-0.411, P=.033). However, this improvement occurred only in patients with less efficient CPM (16.8±16.0 to -1.1±15.5, P<.050). No predictive role was found for TS. In conclusion, the coupling of CPM and duloxetine efficacy highlights the importance of pain pathophysiology in the clinical decision-making process. This evaluative approach promotes personalized pain therapy. Copyright © 2012 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

  11. Prediction of Short- and Medium-term Efficacy of Biosimilar Infliximab Therapy. Do Trough Levels and Antidrug Antibody Levels or Clinical And Biochemical Markers Play the More Important Role?

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    Gonczi, Lorant; Vegh, Zsuzsanna; Golovics, Petra Anna; Rutka, Mariann; Gecse, Krisztina Barbara; Bor, Renata; Farkas, Klaudia; Szamosi, Tamás; Bene, László; Gasztonyi, Beáta; Kristóf, Tünde; Lakatos, László; Miheller, Pál; Palatka, Károly; Papp, Mária; Patai, Árpád; Salamon, Ágnes; Tóth, Gábor Tamás; Vincze, Áron; Biro, Edina; Lovasz, Barbara Dorottya; Kurti, Zsuzsanna; Szepes, Zoltan; Molnár, Tamás; Lakatos, Péter L

    2017-06-01

    Biosimilar infliximab CT-P13 received European Medicines Agency [EMA] approval in June 2013 for all indications of the originator product. In the present study, we aimed to evaluate the predictors of short- and medium-term clinical outcome in patients treated with the biosimilar infliximab at the participating inflammatory bowel disease [IBD] centres in Hungary. Demographic data were collected and a harmonised monitoring strategy was applied. Clinical and biochemical activities were evaluated at Weeks 14, 30, and 54. Trough level [TL] and anti-drug antibody [ADA] concentrations were measured by enzyme-linked immunosorbent assay [ELISA] [LT-005, Theradiag, France] at baseline at 14, 30 and 54 weeks and in two centres at Weeks 2 and 6. A total of 291 consecutive IBD patients (184 Crohn's disease [CD] and 107 ulcerative colitis [UC]) were included. In UC, TLs at Week 2 predicted both clinical response and remission at Weeks 14 and 30 (clinical response/remission at Week 14: area under the curve [AUC] = 0.81, p < 0.001, cut-off: 11.5 μg/ml/AUC = 0.79, p < 0.001, cut-off: 15.3μg/ml; clinical response/remission at Week 30: AUC = 0.79, p = 0.002, cut-off: 11.5 μg/ml/AUC = 0.74, p = 0.006, cut-off: 14.5 μg/ml), whereas ADA positivity at Week 14 was inversely associated with clinical response at Week 30 [58.3% vs 84.8% ,p = 0.04]. Previous anti-tumour necrosis factor [TNF] exposure was inversely associated with short-term clinical remission [Week 2: 18.8% vs 47.8%, p = 0.03, at Week 6: 38.9% vs 69.7%, p = 0.013, at Week 14: 37.5% vs 2.5%, p = 0.06]. In CD, TLs at Week 2 predicted short-term [Week 14 response/remission, AUCTLweek2 = 0.715-0.721, p = 0.05/0.005] but not medium-term clinical efficacy. In addition, early ADA status by Week 14 [p = 0.04-0.05 for Weeks 14 and 30], early clinical response [p < 0.001 for Weeks 30/54] and normal C-reactive protein [CRP] at Week 14 [p = 0.005-0.0001] and previous anti-TNF exposure [p = 0.03-0.0001 for Weeks 14, 30, and 54] were

  12. The Clinical Prediction of Dangerousness.

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    1985-05-01

    8217 8 ings. Szasz (1963) has argued persuasively that clinical predictions of future dangerous behavior are unfairly focused on the mentally ill...Persons labeled paranoid, Szasz states, are readily commitable, while highly dangerous drunken drivers are not. Indeed, dangerousness such as that...Psychology, 31, 492-494. Szasz , T. (1963). Law, liberty and psychiatry. New York: Macmillan. Taft, R. (1955). The ability to judge people. Psychological

  13. Does the aldosterone: renin ratio predict the efficacy of spironolactone over bendroflumethiazide in hypertension? A clinical trial protocol for RENALDO (RENin-ALDOsterone study

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    McInnes Gordon T

    2007-05-01

    Full Text Available Abstract Background High blood pressure is an important determinant of cardiovascular disease risk. Treated hypertensives do not attain a risk level equivalent to normotensives. This may be a consequence of suboptimal blood pressure control to which indiscriminate use of antihypertensive drugs may contribute. Indeed the recent ALLHAT1study suggests that thiazides should be given first to virtually all hypertensives. Whether this is correct or whether different antihypertensive therapies should be targeted towards different patients is a major unresolved issue, which we address in this study. The measurement of the ratio of aldosterone: renin is used to identify hypertensive subjects who may respond well to treatment with the aldosterone antagonist spironolactone. It is not known if subjects with a high ratio have aldosteronism or aldosterone-sensitive hypertension is debated but it is important to know whether spironolactone is superior to other diuretics such as bendroflumethiazide in this setting. Methods/design The study is a double-blind, randomised, crossover, controlled trial that will randomise 120 hypertensive subjects to 12 weeks treatment with spironolactone 50 mg once daily and 12 weeks treatment with bendroflumethiazide 2.5 mg once daily. The 2 treatment periods are separated by a 2-week washout period. Randomisation is stratified by aldosterone: renin ratio to include equal numbers of subjects with high and low aldosterone: renin ratios. Primary Objective – To test the hypothesis that the aldosterone: renin ratio predicts the antihypertensive response to spironolactone, specifically that the effect of spironolactone 50 mg is greater than that of bendroflumethiazide 2.5 mg in hypertensive subjects with high aldosterone: renin ratios. Secondary Objectives – To determine whether bendroflumethiazide induces adverse metabolic abnormalities, especially in subjects with high aldosterone: renin ratios and if baseline renin measurement

  14. The importance of exercise self-efficacy for clinical outcomes in pulmonary rehabilitation.

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    Selzler, Anne-Marie; Rodgers, Wendy M; Berry, Tanya R; Stickland, Michael K

    2016-11-01

    Pulmonary rehabilitation (PR) improves functional exercise capacity and health status in people with chronic obstructive pulmonary disease (COPD), although these outcomes are often not maintained following PR. Self-efficacy is a precursor to outcomes achievement, yet few studies have examined the importance of self-efficacy to outcome improvement during PR, or how it develops over time. Further, the contribution of exercise-specific self-efficacy to outcomes in PR is unknown. The aims of this study were to determine (a) whether baseline exercise self-efficacy predicts PR attendance and change in functional exercise capacity and health status over PR, and (b) if exercise self-efficacy changes with PR. Fifty-eight out of 64 patients with COPD completed PR and assessments of exercise self-efficacy (task, coping, scheduling), the 6-minute walk test (6MWT), and St. George's Respiratory Questionnaire (SGRQ) at the beginning and end of PR. Analyses were conducted to predict attendance, and change in 6MWT and SGRQ, while controlling for baseline demographic and clinical indicators. Change in 6MWT, SGRQ, and self-efficacy with PR was also examined. Clinically significant increases in the 6MWT and SGRQ were achieved with PR. Stronger task self-efficacy predicted better attendance, while stronger coping self-efficacy predicted greater 6MWT improvement. No variables predicted SGRQ change. Scheduling self-efficacy significantly improved with PR, whereas task and coping self-efficacy did not. Baseline exercise self-efficacy appears to be a determinant of rehabilitation attendance and functional exercise improvement with PR. Clinicians should evaluate and target exercise self-efficacy to maximize adherence and health outcome improvement with PR. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

  15. Predictive markers of efficacy for an angiopoietin-2 targeting therapeutic in xenograft models.

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    Gallen Triana-Baltzer

    Full Text Available The clinical efficacy of anti-angiogenic therapies has been difficult to predict, and biomarkers that can predict responsiveness are sorely needed in this era of personalized medicine. CVX-060 is an angiopoietin-2 (Ang2 targeting therapeutic, consisting of two peptides that bind Ang2 with high affinity and specificity, covalently fused to a scaffold antibody. In order to optimize the use of this compound in the clinic the construction of a predictive model is described, based on the efficacy of CVX-060 in 13 cell line and 2 patient-derived xenograft models. Pretreatment size tumors from each of the models were profiled for the levels of 27 protein markers of angiogenesis, SNP haplotype in 5 angiogenesis genes, and somatic mutation status for 11 genes implicated in tumor growth and/or vascularization. CVX-060 efficacy was determined as tumor growth inhibition (TGI% at termination of each study. A predictive statistical model was constructed based on the correlation of these efficacy data with the marker profiles, and the model was subsequently tested by prospective analysis in 11 additional models. The results reveal a range of CVX-060 efficacy in xenograft models of diverse tissue types (0-64% TGI, median = 27% and define a subset of 3 proteins (Ang1, EGF, Emmprin, the levels of which may be predictive of TGI by Ang2 blockade. The direction of the associations is such that better efficacy correlates with high levels of target and low levels of compensatory/antagonizing molecules. This effort has revealed a set of candidate predictive markers for CVX-060 efficacy that will be further evaluated in ongoing clinical trials.

  16. Efficacy beliefs predict collaborative practice among intensive care unit nurses

    NARCIS (Netherlands)

    Le Blanc, Pascale M.; Schaufeli, Wilmar B.; Salanova, Marisa; Llorens, Susana; Nap, Raoul E.

    P>Aim. This paper is a report of an investigation of whether intensive care nurses' efficacy beliefs predict future collaborative practice, and to test the potential mediating role of team commitment in this relationship. Background. Recent empirical studies in the field of work and organizational

  17. The job self-efficacy and job involvement of clinical nursing teachers.

    Science.gov (United States)

    Yang, Hui-Ling; Kao, Yu-Hsiu; Huang, Yi-Ching

    2006-09-01

    This paper explored the present status of self-efficacy and job involvement of clinical nursing teachers and investigated the predictive power of teachers' personal background variables on such, as well as the relationship between self-efficacy and job involvement. A total of 419 participants in the survey sample were chosen among clinical nursing teachers at 19 public and private institutes of technology and junior colleges in Taiwan in 2004. The self-developed structural questionnaire was categorized into three sections, including personal background data, job self-efficacy related to the clinical teaching inventory and job involvement related to clinical teaching inventory. Of the total 419 questionnaires distributed for this cross-sectional survey, 266 valid copies were registered, at a recovery rate of 63%. Findings indicated that both the job self-efficacy and job involvement of clinical nursing teachers are at a medium to high level and that significant differences exist in job self-efficacy and job involvement based on differences in age, marital status, teaching seniority, teacher qualifications, and job satisfaction. Second, samples have significantly different performance in self-efficacy due to differences in education level attained and the medical institution to which nursing teachers had been assigned. Self-efficacy and job involvement are significantly positively correlated. These results can serve as a reference for the cultivation of nursing teachers and reform of clinical nursing education in the future.

  18. Prostate Cancer Predictive Simulation Modelling, Assessing the Risk Technique (PCP-SMART): Introduction and Initial Clinical Efficacy Evaluation Data Presentation of a Simple Novel Mathematical Simulation Modelling Method, Devised to Predict the Outcome of Prostate Biopsy on an Individual Basis.

    Science.gov (United States)

    Spyropoulos, Evangelos; Kotsiris, Dimitrios; Spyropoulos, Katherine; Panagopoulos, Aggelos; Galanakis, Ioannis; Mavrikos, Stamatios

    2017-02-01

    We developed a mathematical "prostate cancer (PCa) conditions simulating" predictive model (PCP-SMART), from which we derived a novel PCa predictor (prostate cancer risk determinator [PCRD] index) and a PCa risk equation. We used these to estimate the probability of finding PCa on prostate biopsy, on an individual basis. A total of 371 men who had undergone transrectal ultrasound-guided prostate biopsy were enrolled in the present study. Given that PCa risk relates to the total prostate-specific antigen (tPSA) level, age, prostate volume, free PSA (fPSA), fPSA/tPSA ratio, and PSA density and that tPSA ≥ 50 ng/mL has a 98.5% positive predictive value for a PCa diagnosis, we hypothesized that correlating 2 variables composed of 3 ratios (1, tPSA/age; 2, tPSA/prostate volume; and 3, fPSA/tPSA; 1 variable including the patient's tPSA and the other, a tPSA value of 50 ng/mL) could operate as a PCa conditions imitating/simulating model. Linear regression analysis was used to derive the coefficient of determination (R 2 ), termed the PCRD index. To estimate the PCRD index's predictive validity, we used the χ 2 test, multiple logistic regression analysis with PCa risk equation formation, calculation of test performance characteristics, and area under the receiver operating characteristic curve analysis using SPSS, version 22 (P regression revealed the PCRD index as an independent PCa predictor, and the formulated risk equation was 91% accurate in predicting the probability of finding PCa. On the receiver operating characteristic analysis, the PCRD index (area under the curve, 0.926) significantly (P < .001) outperformed other, established PCa predictors. The PCRD index effectively predicted the prostate biopsy outcome, correctly identifying 9 of 10 men who were eventually diagnosed with PCa and correctly ruling out PCa for 9 of 10 men who did not have PCa. Its predictive power significantly outperformed established PCa predictors, and the formulated risk equation

  19. Profiled support vector machines for antisense oligonucleotide efficacy prediction

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    Martín-Guerrero José D

    2004-09-01

    Full Text Available Abstract Background This paper presents the use of Support Vector Machines (SVMs for prediction and analysis of antisense oligonucleotide (AO efficacy. The collected database comprises 315 AO molecules including 68 features each, inducing a problem well-suited to SVMs. The task of feature selection is crucial given the presence of noisy or redundant features, and the well-known problem of the curse of dimensionality. We propose a two-stage strategy to develop an optimal model: (1 feature selection using correlation analysis, mutual information, and SVM-based recursive feature elimination (SVM-RFE, and (2 AO prediction using standard and profiled SVM formulations. A profiled SVM gives different weights to different parts of the training data to focus the training on the most important regions. Results In the first stage, the SVM-RFE technique was most efficient and robust in the presence of low number of samples and high input space dimension. This method yielded an optimal subset of 14 representative features, which were all related to energy and sequence motifs. The second stage evaluated the performance of the predictors (overall correlation coefficient between observed and predicted efficacy, r; mean error, ME; and root-mean-square-error, RMSE using 8-fold and minus-one-RNA cross-validation methods. The profiled SVM produced the best results (r = 0.44, ME = 0.022, and RMSE= 0.278 and predicted high (>75% inhibition of gene expression and low efficacy (http://aosvm.cgb.ki.se/. Conclusions The SVM approach is well suited to the AO prediction problem, and yields a prediction accuracy superior to previous methods. The profiled SVM was found to perform better than the standard SVM, suggesting that it could lead to improvements in other prediction problems as well.

  20. Clinical studies of biomarkers in suicide prediction

    OpenAIRE

    Jokinen, Jussi

    2007-01-01

    Suicide is a major clinical problem in psychiatry and suicidal behaviours can be seen as a nosological entity per se. Predicting suicide is difficult due to its low base-rate and the limited specificity of clinical predictors. Prospective biological studies suggest that dysfunctions in the hypothalamo pituitary adrenal (HPA) axis and the serotonergic system have predictive power for suicide in mood disorders. Suicide attempt is the most robust clinical predictor making suici...

  1. The Relationship between Clinical Competence and Clinical Self-efficacy among Nursing and Midwifery Students

    Directory of Open Access Journals (Sweden)

    Shahla Mohamadirizi

    2015-12-01

    Full Text Available Introduction  Self-efficacy in clinical performance had an important role in applying competencies; also competencies and self-efficacy in clinical performance influenced to quality care of nursing and midwifery students. So the present study aimed to define the relationship between clinical competencies and clinical self-efficacy among nursing and midwifery students. Materials and Methods  This is a cross-sectional study conducted on 150 of nursing and midwifery students in Isfahan University of Medical Science, selected through two stage sampling in 2014. The participant completed questionnaires about personal/ educational characteristics and nursing competencies questionnaire (18 items and clinical self-efficacy scale (37 items. The data were analyzed by, Pearson statistical test, t-test, variance analysis through SPSS version16. Results The results showed that 50% (n=75 and 37.4% (n=56 of nursing and midwifery students had good clinical competence and clinical Self-Efficacy, respectively. Also the mean competencies and self-efficacy in clinical performance scores were 35.05± 1.2 and 76.03± 0.4 respectively. Pearson correlation coefficient showed that there was a positive linear correlation between the score of clinical competence and clinical self-efficacy (P

  2. Modeling clinical efficacy of the S1P receptor modulator ponesimod in psoriasis.

    Science.gov (United States)

    Krause, Andreas; D'Ambrosio, Daniele; Dingemanse, Jasper

    2018-02-01

    Ponesimod is currently the only S1P receptor modulator studied in psoriasis. In a dose-finding study, the active doses showed similar efficacy. Prediction of efficacy at lower doses to aid clinical phase 3 planning with respect to dose selection, duration of treatment, and patient inclusion criteria based on pharma-co-kinetic/pharmacodynamic (PK/PD) modeling and simulation. The dose-finding study treated 326 patients (67 on placebo, 126 on 20mg, and 133 on 40mg) over 16 weeks. PK/PD modeling of steady-state trough concentrations and longitudinal PASI scores was employed to characterize data and simulate scenarios. PASI score continually decreased with time on ponesimod treatment, reaching a plateau at 16 weeks. Absolute and relative (percent) PASI score change was larger in patients with higher PASI score at baseline. Doses below 10mg were predicted to show lower efficacy than doses of 10mg and higher. Concentration-response modeling was able to predict the efficacy of doses that were not studied. In psoriasis patients, a dose of 10mg (not administered in the study) was predicted to show efficacy similar to 20mg. Disease status (PASI score at baseline) as study inclusion criterion has pronounced influence on study outcome. Copyright © 2017 Japanese Society for Investigative Dermatology. Published by Elsevier B.V. All rights reserved.

  3. Clinical efficacy of radiotherapy combined with sodium glycididazole ...

    African Journals Online (AJOL)

    Purpose: To assess the clinical efficacy and side effects of radiotherapy combined with sodium glycididazole in the treatment of recurrent esophageal carcinoma. Methods: Ninety patients with locally recurrent oesophageal carcinoma who were admitted to the Oncology Department at Taian City Central Hospital, Shandong, ...

  4. Clinical efficacy and safety of edaravone therapy in acute cerebral ...

    African Journals Online (AJOL)

    Purpose: To evaluate the clinical efficacy and safety of edaravone in the treatment of acute cerebral haemorrhage (ACH). Methods: This study recruited 120 patients who developed ACH. The patients were divided into control and treatment groups with 60 patients per group. The control group underwent conventional ...

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

    African Journals Online (AJOL)

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

  6. Clinical efficacy of a tea-bag formulation of Cryptolepis ...

    African Journals Online (AJOL)

    Objective: To evaluate the clinical efficacy and safety of a tea bag formulation of the root of C. sanguinolenta. Design: This is a prospective descriptive open trial. Setting: Patients were recruited from Korle-Bu, Mamprobi and Dansoman Polyclinics. Subjects: Forty-four subjects with uncomplicated malaria were recruited for ...

  7. A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety ...

    African Journals Online (AJOL)

    A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety and Cost Effectiveness of Lornoxicam with Diclofenac Sodium in Patients of Osteoarthritis Knee. ... All patients were assessed with visual analogue scale and 100 meter walking test before starting of therapy, at 15 days and at 1, 2 and 3 months of therapy.

  8. Clinical Efficacy of Psychoeducational Interventions with Family Caregivers

    Science.gov (United States)

    Limiñana-Gras, Rosa M.; Colodro-Conde, Lucía; Cuéllar-Flores, Isabel; Sánchez-López, M. Pilar

    2016-01-01

    The goal of this study is to investigate the efficacy of psychoeducational interventions geared to reducing psychological distress for caregivers in a sample of 90 family caregivers of elderly dependent (78 women and 12 men). We conducted an analysis of the statistical and clinical significance of the changes observed in psychological health…

  9. Clinical efficacy of bromocriptine and the influence of serum ...

    African Journals Online (AJOL)

    Nouran Abdelaziz AbouKhedr

    2013-05-18

    May 18, 2013 ... Clinical efficacy of bromocriptine and the influence of serum prolactin levels on disease severity in patients with chronic plaque-type psoriasis. Nouran Abdelaziz AbouKhedr, Amira Abulfotooh Eid *. Department of Dermatology, Venereology and Andrology, Faculty of Medicine, University of Alexandria, ...

  10. Clinical efficacy of bromocriptine and the influence of serum ...

    African Journals Online (AJOL)

    Background: Psoriasis is a T-cell mediated hyperproliferative cutaneous disease of multifactorial etiology. Prolactin (PRL) has been implicated in the pathogenesis of psoriasis and several studies have pointed to a potential therapeutic role of bromocriptine in psoriasis. Aim: To assess the clinical efficacy of bromocriptine ...

  11. Clinical Prediction Models for Cardiovascular Disease: Tufts Predictive Analytics and Comparative Effectiveness Clinical Prediction Model Database.

    Science.gov (United States)

    Wessler, Benjamin S; Lai Yh, Lana; Kramer, Whitney; Cangelosi, Michael; Raman, Gowri; Lutz, Jennifer S; Kent, David M

    2015-07-01

    Clinical prediction models (CPMs) estimate the probability of clinical outcomes and hold the potential to improve decision making and individualize care. For patients with cardiovascular disease, there are numerous CPMs available although the extent of this literature is not well described. We conducted a systematic review for articles containing CPMs for cardiovascular disease published between January 1990 and May 2012. Cardiovascular disease includes coronary heart disease, heart failure, arrhythmias, stroke, venous thromboembolism, and peripheral vascular disease. We created a novel database and characterized CPMs based on the stage of development, population under study, performance, covariates, and predicted outcomes. There are 796 models included in this database. The number of CPMs published each year is increasing steadily over time. Seven hundred seventeen (90%) are de novo CPMs, 21 (3%) are CPM recalibrations, and 58 (7%) are CPM adaptations. This database contains CPMs for 31 index conditions, including 215 CPMs for patients with coronary artery disease, 168 CPMs for population samples, and 79 models for patients with heart failure. There are 77 distinct index/outcome pairings. Of the de novo models in this database, 450 (63%) report a c-statistic and 259 (36%) report some information on calibration. There is an abundance of CPMs available for a wide assortment of cardiovascular disease conditions, with substantial redundancy in the literature. The comparative performance of these models, the consistency of effects and risk estimates across models and the actual and potential clinical impact of this body of literature is poorly understood. © 2015 American Heart Association, Inc.

  12. Does Self-Efficacy Affect Cognitive Performance in Persons with Clinically Isolated Syndrome and Early Relapsing Remitting Multiple Sclerosis?

    Directory of Open Access Journals (Sweden)

    Peter Joseph Jongen

    2015-01-01

    Full Text Available In persons with multiple sclerosis (MS a lowered self-efficacy negatively affects physical activities. Against this background we studied the relationship between self-efficacy and cognitive performance in the early stages of MS. Thirty-three patients with Clinically Isolated Syndrome (CIS and early Relapsing Remitting MS (eRRMS were assessed for self-efficacy (MSSES-18, cognition (CDR System, fatigue (MFIS-5, depressive symptoms (BDI, disease impact (MSIS-29, and disability (EDSS. Correlative analyses were performed between self-efficacy and cognitive scores, and stepwise regression analyses identified predictors of cognition and self-efficacy. Good correlations existed between total self-efficacy and Power of Attention (r= 0.65; P< 0.001, Reaction Time Variability (r= 0.57; P< 0.001, and Speed of Memory (r= 0.53; P< 0.01, and between control self-efficacy and Reaction Time Variability (r= 0.55; P< 0.01. Total self-efficacy predicted 40% of Power of Attention, 34% of Reaction Time Variability, and 40% of Speed of Memory variabilities. Disease impact predicted 65% of total self-efficacy and 58% of control self-efficacy variabilities. The findings may suggest that in persons with CIS and eRRMS self-efficacy may positively affect cognitive performance and that prevention of disease activity may preserve self-efficacy.

  13. WHAT DOES PROVIDE A CLINICAL EFFICACY OF METOPROLOL?

    Directory of Open Access Journals (Sweden)

    E. V. Kuleshova

    2010-01-01

    Full Text Available Relationship of metoprolol clinical efficacy with its different salts (tartrate, succinate, fumarate as well as its presentations (tablets with immediate, controlled or sustained release is analyzed. It is highlighted that pharmacodynamic properties depend on metoprolol molecule only. These properties do not change after modification of drug presentation or metoprolol plasma concentration which depends on velocity of drug release from the tablet. Data of randomized clinical trials are discussed in regard to development of evidence base for use of different metoprolol presentations in treatment of patients with arterial hypertension, unstable angina, myocardial infarction, heart failure. Indications for tartrate and succinate salts of metoprolol are presented. Results of clinical studies on efficacy of metoprolol tartrate in long-acting drug presentations are analyzed.

  14. Radiogenomics: predicting clinical normal tissue radiosensitivity

    DEFF Research Database (Denmark)

    Alsner, Jan

    2006-01-01

    Studies on the genetic basis of normal tissue radiosensitivity, or  'radiogenomics', aims at predicting clinical radiosensitivity and optimize treatment from individual genetic profiles. Several studies have now reported links between variations in certain genes related to the biological response...... to radiation injury and risk of normal tissue morbidity in cancer patients treated with radiotherapy. However, after these initial association studies including few genes, we are still far from being able to predict clinical radiosensitivity on an individual level. Recent data from our own studies on risk...

  15. What predicts performance during clinical psychology training?

    OpenAIRE

    Scior, Katrina; Bradley, Caroline E; Potts, Henry W W; Woolf, Katherine; de C Williams, Amanda C

    2013-01-01

    Objectives While the question of who is likely to be selected for clinical psychology training has been studied, evidence on performance during training is scant. This study explored data from seven consecutive intakes of the UK's largest clinical psychology training course, aiming to identify what factors predict better or poorer outcomes. Design Longitudinal cross-sectional study using prospective and retrospective data. Method Characteristics at application were analysed in relation to a r...

  16. [Clinical efficacy of flomoxef in the field of pediatrics].

    Science.gov (United States)

    Ogura, H; Kubota, H; Murakami, N; Tomoda, T; Hamada, F; Matsumoto, K; Araki, K; Ogura, Y; Kurashige, T; Kitamura, I

    1987-08-01

    A new oxacephem antibiotic, flomoxef sodium (FMOX, 6315-S), was studied for its clinical efficacy in the field of pediatrics. The treated patients were infants and children ranging from 6 months to 14 years old suffering from bacterial pneumonia in 3 cases, acute tonsillitis in 2 cases, acute enterocolitis in 2 cases, and cellulitis and urinary tract infection in 1 case each, a total of 9 cases. FMOX was administered at (levels of) 57-150 mg/kg in daily dose with durations of treatment ranging from 5 to 18 days. Clinical efficacies of good or excellent results were obtained in all cases (excellent in 4, good in 5). As an adverse reaction, eosinophilia was observed in 1 patient. This elevation is, however, normalized with the cessation of the treatment.

  17. Physiotherapy clinical educators' perceptions and experiences of clinical prediction rules.

    Science.gov (United States)

    Knox, Grahame M; Snodgrass, Suzanne J; Rivett, Darren A

    2015-12-01

    Clinical prediction rules (CPRs) are widely used in medicine, but their application to physiotherapy practice is more recent and less widespread, and their implementation in physiotherapy clinical education has not been investigated. This study aimed to determine the experiences and perceptions of physiotherapy clinical educators regarding CPRs, and whether they are teaching CPRs to students on clinical placement. Cross-sectional observational survey using a modified Dillman method. Clinical educators (n=211, response rate 81%) supervising physiotherapy students from 10 universities across 5 states and territories in Australia. Half (48%) of respondents had never heard of CPRs, and a further 25% had never used CPRs. Only 27% reported using CPRs, and of these half (51%) were rarely if ever teaching CPRs to students in the clinical setting. However most respondents (81%) believed CPRs assisted in the development of clinical reasoning skills and few (9%) were opposed to teaching CPRs to students. Users of CPRs were more likely to be male (pphysiotherapy (pStudents are unlikely to be learning about CPRs on clinical placement, as few clinical educators use them. Clinical educators will require training in CPRs and assistance in teaching them if students are to better learn about implementing CPRs in physiotherapy clinical practice. Copyright © 2015 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

  18. Alflutop clinical efficacy assessment in osteoarthritis (two-years study

    Directory of Open Access Journals (Sweden)

    V. N. Chodyrev

    2003-01-01

    Full Text Available Objective. To assess alflutop clinical efficacy and safety during long-term course treatment of knee osteoarthritis. Methods. 51 pts with definite knee osteoarthritis of I-III stage according to Kellgren-Lawrence classification were included in an open controlled study. 20 pts received 6 intra-articular injections of alflutop 2 ml with subsequent intramuscular treatment during 3 months. Such courses were repeated 6 months apart for 2 years. 31 pts of control group received nonsteroidal anti-inflammatory drugs (NSAID only. Pain on visual analog scale, Leken functional score, changes of NSAID treatment and radiological picture were used for assessment of efficacy. Clinical examination was performed before and after every treatment course and 3 months after the last course. Results. Every alflutop treatment course provided significant stepwise decrease of pain with improvement of mobility, reduction of NSAID requirement and absence of osteoarthritis radiological progression. Doctor and pts clinical efficacy and safety assessment coincided. Conclusion. Alflutop is an effective drug for knee osteoarthritis treatment. It has anti-inflammatory and probably chondroprotective activity with good safety.

  19. Mathematical modeling of efficacy and safety for anticancer drugs clinical development.

    Science.gov (United States)

    Lavezzi, Silvia Maria; Borella, Elisa; Carrara, Letizia; De Nicolao, Giuseppe; Magni, Paolo; Poggesi, Italo

    2018-01-01

    Drug attrition in oncology clinical development is higher than in other therapeutic areas. In this context, pharmacometric modeling represents a useful tool to explore drug efficacy in earlier phases of clinical development, anticipating overall survival using quantitative model-based metrics. Furthermore, modeling approaches can be used to characterize earlier the safety and tolerability profile of drug candidates, and, thus, the risk-benefit ratio and the therapeutic index, supporting the design of optimal treatment regimens and accelerating the whole process of clinical drug development. Areas covered: Herein, the most relevant mathematical models used in clinical anticancer drug development during the last decade are described. Less recent models were considered in the review if they represent a standard for the analysis of certain types of efficacy or safety measures. Expert opinion: Several mathematical models have been proposed to predict overall survival from earlier endpoints and validate their surrogacy in demonstrating drug efficacy in place of overall survival. An increasing number of mathematical models have also been developed to describe the safety findings. Modeling has been extensively used in anticancer drug development to individualize dosing strategies based on patient characteristics, and design optimal dosing regimens balancing efficacy and safety.

  20. A linear programming computational framework integrates phosphor-proteomics and prior knowledge to predict drug efficacy.

    Science.gov (United States)

    Ji, Zhiwei; Wang, Bing; Yan, Ke; Dong, Ligang; Meng, Guanmin; Shi, Lei

    2017-12-21

    In recent years, the integration of 'omics' technologies, high performance computation, and mathematical modeling of biological processes marks that the systems biology has started to fundamentally impact the way of approaching drug discovery. The LINCS public data warehouse provides detailed information about cell responses with various genetic and environmental stressors. It can be greatly helpful in developing new drugs and therapeutics, as well as improving the situations of lacking effective drugs, drug resistance and relapse in cancer therapies, etc. In this study, we developed a Ternary status based Integer Linear Programming (TILP) method to infer cell-specific signaling pathway network and predict compounds' treatment efficacy. The novelty of our study is that phosphor-proteomic data and prior knowledge are combined for modeling and optimizing the signaling network. To test the power of our approach, a generic pathway network was constructed for a human breast cancer cell line MCF7; and the TILP model was used to infer MCF7-specific pathways with a set of phosphor-proteomic data collected from ten representative small molecule chemical compounds (most of them were studied in breast cancer treatment). Cross-validation indicated that the MCF7-specific pathway network inferred by TILP were reliable predicting a compound's efficacy. Finally, we applied TILP to re-optimize the inferred cell-specific pathways and predict the outcomes of five small compounds (carmustine, doxorubicin, GW-8510, daunorubicin, and verapamil), which were rarely used in clinic for breast cancer. In the simulation, the proposed approach facilitates us to identify a compound's treatment efficacy qualitatively and quantitatively, and the cross validation analysis indicated good accuracy in predicting effects of five compounds. In summary, the TILP model is useful for discovering new drugs for clinic use, and also elucidating the potential mechanisms of a compound to targets.

  1. Predictive efficacy of radioisotope voiding cystography for renal outcome

    International Nuclear Information System (INIS)

    Kim, Seok Ki; Lee, Dong Soo; Kim, Kwang Myeung; Choi, Whang; Chung, June Key; Lee, Myung Chul

    2000-01-01

    As vesicoureteral reflux (VUR) could lead to renal functional deterioration when combined with urinary tract infection, we need to decide whether operative anti-reflux treatment should be performed at the time of diagnosis of VUR. Predictive value of radioisotope voiding cystography (RIVCG) for renal outcome was tested. In 35 children (18 males, 17 females), radiologic voiding cystoure-thrography (VCU), RIVCG and DMSA scan were performed. Change in renal function was evaluated using the follow-up DMSA scan, ultrasonography, and clinical information. Discriminant analysis was performed using individual or integrated variables such as reflux amount and extent at each phase of voiding on RIVCG, in addition to age, gender and cortical defect on DMSA scan at the time of diagnosis. Discriminant function was composed and its performance was examined. Reflux extent at the filling phase and reflux amount and extent at postvoiding phase had a significant prognostic value. Total reflux amount was a composite variable to predict prognosis. Discriminant function composed of reflux extent at the filling phase and reflux amount and extent at postvoiding phase showed better positive predictive value and specificity than conventional reflux grading. RIVCG could predict renal outcome by disclosing characteristic reflux pattern during various voiding phases.=20

  2. [Clinical efficacy of flomoxef in neonatal bacterial infection].

    Science.gov (United States)

    Sakata, H; Hirano, Y; Maruyama, S

    1993-03-01

    One hundred and seventy one neonates were treated with flomoxef (FMOX) and the clinical efficacy and safety were evaluated. The ages of the patients ranged from 0 to 28 days, and their body weights from 450 to 4300 g. Dose levels were 12.4 to 24.9 mg/kg every 8 or 12 hours for 1 to 10 days. Fifty two patients who responded to the FMOX treatment included 5 neonates with sepsis, 17 with suspected sepsis, 9 with urinary tract infections, 12 with pneumonia, 8 with intrauterine infections, and 1 with omphalitis. The other neonates could not be retrospectively diagnosed as bacterial infections. Of 52 patients, clinical results were excellent in 15, good in 34, fair in 1, and poor in 2. And the FMOX treatment was effective in 13 out of 14 patients in which causative bacteria were identified. The drug was well tolerated, but 6 neonates out of 33 over 5 days old had diarrhea. From these results, empiric treatment with FMOX against neonatal bacterial infection was as clinically useful as that of combination with ampicillin and gentamicin or cefotaxime and ampicillin in our neonatal intensive care unit. But, as this study did not include neonate with meningitis, efficacy to meningitis was not evaluated.

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

    International Nuclear Information System (INIS)

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

    2003-01-01

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

  4. Illness severity and self-efficacy as course predictors of DSM-IV alcohol dependence in a multisite clinical sample.

    Science.gov (United States)

    Langenbucher, J; Sulesund, D; Chung, T; Morgenstern, J

    1996-01-01

    Illness severity and self-efficacy are two constructs of growing interest as predictors of clinical response in alcoholism. Using alternative measures of illness severity (DSM-IV symptom count, Alcohol Dependence Scale, and Addiction Severity Index) and self-efficacy (brief version of the Situational Confidence Questionnaire) rigorously controlled for theoretically important background variables, we studied their unique contribution to multiple indices of relapse, relapse latency, and use of alternative coping behaviors in a large, heterogeneous clinical sample. The Alcohol Dependence Scale contributed to the prediction of 4 of 5 relapse indicators. The SCQ failed to predict relapse behavior or its precursor, coping response. The findings emphasize the predictive validity of severity of dependence as a course specifier and underline the need for more sensitive and externally valid measures of cognitive processes such as self-efficacy for application in future studies of posttreatment behavior.

  5. Teacher' Interpersonal Self-Efficacy: Evaluation and Predictive Capacity of Teacher Burnout

    Science.gov (United States)

    García-Ros, Rafael; Fuentes, María C.; Fernández, Basilio

    2015-01-01

    Introduction: This study analyzed the predictive capacity and incremental validity of teachers' interpersonal self-efficacy on their levels of burnout. First, it presents the validation process of a Spanish adaptation of the Teacher Interpersonal Self-Efficacy Scale--TISES--(Browers & Tomic, 1999, 2001). Second, the predictive capacity of…

  6. Spinal Cord Stimulation: Clinical Efficacy and Potential Mechanisms.

    Science.gov (United States)

    Sdrulla, Andrei D; Guan, Yun; Raja, Srinivasa N

    2018-03-11

    Spinal cord stimulation (SCS) is a minimally invasive therapy used for the treatment of chronic neuropathic pain. SCS is a safe and effective alternative to medications such as opioids, and multiple randomized controlled studies have demonstrated efficacy for difficult-to-treat neuropathic conditions such as failed back surgery syndrome. Conventional SCS is believed mediate pain relief via activation of dorsal column Aβ fibers, resulting in variable effects on sensory and pain thresholds, and measurable alterations in higher order cortical processing. Although potentiation of inhibition, as suggested by Wall and Melzack's gate control theory, continues to be the leading explanatory model, other segmental and supraspinal mechanisms have been described. Novel, non-standard, stimulation waveforms such as high-frequency and burst have been shown in some studies to be clinically superior to conventional SCS, however their mechanisms of action remain to be determined. Additional studies are needed, both mechanistic and clinical, to better understand optimal stimulation strategies for different neuropathic conditions, improve patient selection and optimize efficacy. © 2018 World Institute of Pain.

  7. Time-dependent efficacy of longitudinal biomarker for clinical endpoint.

    Science.gov (United States)

    Kolamunnage-Dona, Ruwanthi; Williamson, Paula R

    2018-06-01

    Joint modelling of longitudinal biomarker and event-time processes has gained its popularity in recent years as they yield more accurate and precise estimates. Considering this modelling framework, a new methodology for evaluating the time-dependent efficacy of a longitudinal biomarker for clinical endpoint is proposed in this article. In particular, the proposed model assesses how well longitudinally repeated measurements of a biomarker over various time periods (0,t) distinguish between individuals who developed the disease by time t and individuals who remain disease-free beyond time t. The receiver operating characteristic curve is used to provide the corresponding efficacy summaries at various t based on the association between longitudinal biomarker trajectory and risk of clinical endpoint prior to each time point. The model also allows detecting the time period over which a biomarker should be monitored for its best discriminatory value. The proposed approach is evaluated through simulation and illustrated on the motivating dataset from a prospective observational study of biomarkers to diagnose the onset of sepsis.

  8. e-Consultation Improves Efficacy in Thoracic Surgery Outpatient Clinics.

    Science.gov (United States)

    Novoa, Nuria M; Gómez, Maria Teresa; Rodríguez, María; Jiménez López, Marcelo F; Aranda, Jose L; Bollo de Miguel, Elena; Diez, Florentino; Hernández Hernández, Jesús; Varela, Gonzalo

    2016-11-01

    The aim of this study is analysing the impact of the systematic versus occasional videoconferencing discussion of patients with two respiratory referral units along 6 years of time over the efficiency of the in-person outpatient clinics of a thoracic surgery service. Retrospective and comparative study of the evaluated patients through videoconferencing and in-person first visits during two equivalents periods of time: Group A (occasional discussion of cases) between 2008-2010 and Group B (weekly regular discussion) 2011-2013. Data were obtained from two prospective and electronic data bases. The number of cases discussed using e-consultation, in-person outpatient clinics evaluation and finally operated on under general anaesthesia in each period of time are presented. For efficiency criteria, the index: number of operated on cases/number of first visit outpatient clinic patients is created. Non-parametric Wilcoxon test is used for comparison. The mean number of patients evaluated at the outpatient clinics/year on group A was 563 versus 464 on group B. The median number of cases discussed using videoconferencing/year was 42 for group A versus 136 for group B. The mean number of operated cases/first visit at the outpatient clinics was 0.7 versus 0.87 in group B (P=.04). The systematic regular discussion of cases using videoconferencing has a positive impact on the efficacy of the outpatient clinics of a Thoracic Surgery Service measured in terms of operated cases/first outpatient clinics visit. Copyright © 2016 SEPAR. Publicado por Elsevier España, S.L.U. All rights reserved.

  9. Diagnostic efficacy and therapeutic impact of computed tomography in the evaluation of clinically suspected otosclerosis

    International Nuclear Information System (INIS)

    Dudau, Cristina; Salim, Fakhruddin; Jiang, Dan; Connor, Steve E.J.

    2017-01-01

    To assess the diagnostic efficacy and therapeutic impact of CT in evaluating patients with clinically suspected otosclerosis. CT scans performed over a 5-year period for clinically suspected otosclerosis were retrospectively reviewed. CT diagnoses were correlated with subsequent surgical management. For otosclerosis positive cases, clinically significant extensions of otosclerosis were correlated with audiometry and the diagnosis was correlated with surgical findings. Of 259 CT studies, 46 % of patients were positive, 49 % negative and 5 % equivocal for otosclerosis. A relevant alternative CT diagnosis was evident in 33 % of the negative studies. One targeted surgery was performed for every four CT studies. CT outcome influenced the decision to perform stapedectomy in 41 % CT-positive versus 4 % CT-negative patients. CT-positive ears for otosclerosis could not be predicted from baseline clinical or audiometric criteria. Those with endosteal extension demonstrated lower bone conduction thresholds presurgically. The positive predictive value of CT diagnosis of otosclerosis was 100 %. CT demonstrated a high rate of clinically relevant diagnoses in both CT-positive and -negative for otosclerosis patients, and this frequently influenced surgical management. CT also added value by demonstrating relevant extensions of the otosclerotic foci, some of which were predictive of audiometric parameters. (orig.)

  10. Diagnostic efficacy and therapeutic impact of computed tomography in the evaluation of clinically suspected otosclerosis

    Energy Technology Data Exchange (ETDEWEB)

    Dudau, Cristina [King' s College Hospital NHS Foundation Trust, Department of Neuroradiology, London (United Kingdom); Salim, Fakhruddin; Jiang, Dan [Department of Otolaryngology, Head and Neck Surgery, Auditory Implantation Centre, London (United Kingdom); Connor, Steve E.J. [Department of Radiology, Guy' s and St Thomas' NHS Foundation Trust, London (United Kingdom)

    2017-03-15

    To assess the diagnostic efficacy and therapeutic impact of CT in evaluating patients with clinically suspected otosclerosis. CT scans performed over a 5-year period for clinically suspected otosclerosis were retrospectively reviewed. CT diagnoses were correlated with subsequent surgical management. For otosclerosis positive cases, clinically significant extensions of otosclerosis were correlated with audiometry and the diagnosis was correlated with surgical findings. Of 259 CT studies, 46 % of patients were positive, 49 % negative and 5 % equivocal for otosclerosis. A relevant alternative CT diagnosis was evident in 33 % of the negative studies. One targeted surgery was performed for every four CT studies. CT outcome influenced the decision to perform stapedectomy in 41 % CT-positive versus 4 % CT-negative patients. CT-positive ears for otosclerosis could not be predicted from baseline clinical or audiometric criteria. Those with endosteal extension demonstrated lower bone conduction thresholds presurgically. The positive predictive value of CT diagnosis of otosclerosis was 100 %. CT demonstrated a high rate of clinically relevant diagnoses in both CT-positive and -negative for otosclerosis patients, and this frequently influenced surgical management. CT also added value by demonstrating relevant extensions of the otosclerotic foci, some of which were predictive of audiometric parameters. (orig.)

  11. [Clinical efficacy of Viagra with behavior therapy against premature ejaculation].

    Science.gov (United States)

    Tang, Wenhao; Ma, Lulin; Zhao, Lianming; Liu, Yuqing; Chen, Zhenwen

    2004-05-01

    To study the efficacy of Viagra combined with behavior therapy against premature ejaculation (PE). Sixty PE patients were divided into two groups randomly: control group (behavior therapy alone) and the group of Viagra combined with behavior therapy. Intra-vaginal ejaculation latency time (IELT) and the coitus satisfaction of the patient and the partner were recorded before and after treatment. The IELTs of the two groups were 0.80 +/- 0.20 and 0.73 +/- 0.24 minutes respectively before treatment, and 1.82 +/- 0.54 and 3.63 +/- 0.55 minutes respectively after treatment. As for IELT and satisfaction degree, Viagra produced better result than behavior therapy. During this clinical trial, Viagra combined with behavior therapy prolonged IELT, which suggests that Viagra may be helpful for the treatment of premature ejaculation.

  12. Efficacy of clinical supervision: influence on job satisfaction, burnout and quality of care.

    Science.gov (United States)

    Hyrkäs, Kristiina; Appelqvist-Schmidlechner, Kaija; Haataja, Riina

    2006-08-01

    This paper reports a study to determine how supervisees' backgrounds and surrounding infrastructure predict the efficacy of clinical supervision among Finnish nursing staff, their job satisfaction, levels of burnout and perceptions of the quality of care. Several studies have described the effects of clinical supervision, but few have focused on evaluating it. Until recently, no studies have examined how clinical supervision evaluations are related to supervisees' backgrounds, surrounding infrastructure or respondents' levels of burnout, job satisfaction and perceptions of the quality of care. The survey involved supervisees completing a range of standardized and validated evaluation measures. The respondents were identified from 12 regional, central and university hospitals across Finland (n = 799). The data collection took place from October 2000 to February 2001. The evaluations varied statistically significantly and were associated with statistically significant variations in the respondents' backgrounds. Clinical supervision infrastructure was also strongly related to evaluation scores. Supervisees' age, education, gender, employment status, area of specialty, working hours, work experience and experience as a supervisor were statistically significant predictors for evaluations of the efficacy of clinical supervision. These evaluations of clinical supervision were also found to predict the respondents' job satisfaction, levels of burnout and assessments of good nursing. Nursing staff, especially those who have over 10 years' work experience, work in general care, have a nursing diploma, are non-tenured, work part-time and work 24-hour rotating shifts can benefit from clinical supervision. However, resources need to be invested in supervisor education and nursing staff need to be encouraged to start working in both supervisor and supervisee roles because of the positive effects on job satisfaction and quality of care.

  13. Prediction of the Pharmacokinetics, Pharmacodynamics, and Efficacy of a Monoclonal Antibody, Using a Physiologically Based Pharmacokinetic FcRn Model

    Science.gov (United States)

    Chetty, Manoranjenni; Li, Linzhong; Rose, Rachel; Machavaram, Krishna; Jamei, Masoud; Rostami-Hodjegan, Amin; Gardner, Iain

    2015-01-01

    Although advantages of physiologically based pharmacokinetic models (PBPK) are now well established, PBPK models that are linked to pharmacodynamic (PD) models to predict pharmacokinetics (PK), PD, and efficacy of monoclonal antibodies (mAbs) in humans are uncommon. The aim of this study was to develop a PD model that could be linked to a physiologically based mechanistic FcRn model to predict PK, PD, and efficacy of efalizumab. The mechanistic FcRn model for mAbs with target-mediated drug disposition within the Simcyp population-based simulator was used to simulate the pharmacokinetic profiles for three different single doses and two multiple doses of efalizumab administered to virtual Caucasian healthy volunteers. The elimination of efalizumab was modeled with both a target-mediated component (specific) and catabolism in the endosome (non-specific). This model accounted for the binding between neonatal Fc receptor (FcRn) and efalizumab (protective against elimination) and for changes in CD11a target concentration. An integrated response model was then developed to predict the changes in mean Psoriasis Area and Severity Index (PASI) scores that were measured in a clinical study as an efficacy marker for efalizumab treatment. PASI scores were approximated as continuous and following a first-order asymptotic progression model. The reported steady state asymptote (Y ss) and baseline score [Y (0)] was applied and parameter estimation was used to determine the half-life of progression (Tp) of psoriasis. Results suggested that simulations using this model were able to recover the changes in PASI scores (indicating efficacy) observed during clinical studies. Simulations of both single dose and multiple doses of efalizumab concentration-time profiles as well as suppression of CD11a concentrations recovered clinical data reasonably well. It can be concluded that the developed PBPK FcRn model linked to a PD model adequately predicted PK, PD, and efficacy of efalizumab. PMID

  14. Can We Predict the Efficacy of Anti-TNF-α Agents?

    Science.gov (United States)

    Lopetuso, Loris Riccardo; Gerardi, Viviana; Papa, Valerio; Scaldaferri, Franco; Rapaccini, Gian Lodovico; Gasbarrini, Antonio; Papa, Alfredo

    2017-09-14

    The use of biologic agents, particularly anti-tumor necrosis factor (TNF)-α, has revolutionized the treatment of inflammatory bowel diseases (IBD), modifying their natural history. Several data on the efficacy of these agents in inducing and maintaining clinical remission have been accumulated over the past two decades: their use avoid the need for steroids therapy, promote mucosal healing, reduce hospitalizations and surgeries and therefore dramatically improve the quality of life of IBD patients. However, primary non-response to these agents or loss of response over time mainly due to immunogenicity or treatment-related side-effects are a frequent concern in IBD patients. Thus, the identification of predicting factors of efficacy is crucial to allow clinicians to efficiently use these therapies, avoiding them when they are ineffective and eventually shifting towards alternative biological therapies with the end goal of optimizing the cost-effectiveness ratio. In this review, we aim to identify the predictive factors of short- and long-term benefits of anti-TNF-α therapy in IBD patients. In particular, multiple patient-, disease- and treatment-related factors have been evaluated.

  15. Influence of motivation, self-efficacy and situational factors on the teaching quality of clinical educators.

    Science.gov (United States)

    Dybowski, Christoph; Sehner, Susanne; Harendza, Sigrid

    2017-05-08

    Being exposed to good teachers has been shown to enhance students' knowledge and their clinical performance, but little is known about the underlying psychological mechanisms that provide the basis for being an excellent medical teacher. Self-Determination Theory (SDT) postulates that more self-regulated types of motivation are associated with higher performance. Social Cognitive Theory (SCT) focuses on self-efficacy that has been shown to be positively associated with performance. To investigate the influences of different types of teaching motivation, teaching self-efficacy, and teachers' perceptions of students' skills, competencies and motivation on teaching quality. Before the winter semester 2014, physicians involved in bedside teaching in internal medicine at the University Medical Center Hamburg-Eppendorf completed a questionnaire with sociodemographic items and instruments measuring different dimensions of teaching motivation as well as teaching self-efficacy. During the semester, physicians rated their perceptions of the participating students who rated the teaching quality after each lesson. We performed a random intercept mixed-effects linear regression with students' ratings of teaching quality as the dependent variable and students' general interest in a subject as covariate. We explored potential associations between teachers' dispositions and their perceptions of students' competencies in a mixed-effects random intercept logistic regression. 94 lessons given by 55 teachers with 500 student ratings were analyzed. Neither teaching motivation nor teaching self-efficacy were directly associated with students' rating of teaching quality. Teachers' perceptions of students' competencies and students' general interest in the lesson's subject were positively associated with students' rating of teaching quality. Physicians' perceptions of their students' competencies were significantly positively predicted by their teaching self-efficacy. Teaching quality

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

    Directory of Open Access Journals (Sweden)

    David Gonçalves Nordon

    2013-06-01

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

  17. Clinical efficacy of ampicillin in treatment of acute odontogenic abscess

    Directory of Open Access Journals (Sweden)

    Matijević Stevo

    2009-01-01

    Full Text Available Background/Aim. Antibiotics choice and the duration of their application in the therapy of acute odontogenic abscess is considered to be controversial. The aim of this study was to investigate the clinical efficacy of ampicillin in treatment of acute odontogenic abscess and to assess the antimicrobial susceptibility of the isolated bacteria in early phase of abscess development. Methods. This study included 60 patients with acute odontogenic abscess who were surgically treated (extraction of teeth and/or abscess incision divided into two groups, ampicillin group and surgical group (without antibiotic treatment. Results. In the ampicillin group of patients treatment lasted on the average 4.67 days, while in the surgical group 6.17 days. A total of 78 bacterial strains were isolated from 60 patients. The most often bacteria were found to be Gram-positive facultative anaerobs (68/78. The most common bacteria isolated were Viridans streptococci (43/78. Susceptibility of isolated bacteria to ampicillin were 70.5%. Conclusion. Peroral use of ampicillin, after surgical treatment in an early phase of dentoalveolar abscess development, statistically significantly reduced the time of clinical symptoms of acute odontogenic abscess in comparison to surgical treatment only. The isolated bacterial strains in an early phase of dentoalveolar abscess development showed a high sensitivity to ampicillin.

  18. Efficacy of clinical diagnostic procedures utilized in nuclear medicine. Nine month progress report

    Energy Technology Data Exchange (ETDEWEB)

    None

    1978-01-01

    This study is designed to determine the efficacy of nuclear medicine procedures in clinical practice. Several methods of determining efficacy will be evaluated to determine those most suitable. Nuclear medicine methods will be confined to the study of lung diseases by pulmonary perfusion and ventilation. In addition to evaluating the above methods data will be obtained to determine the sensitivity, specificity, predictive value and efficiency of the test under consideration. These values, corrected for prevalence of the disease processes under consideration will then be compared to the values obtained by the MACRO and MICRO methods and will help to bound the clinical reliability of the diagnostic method depending on the degree to which the several methods trend together. Depending on the practicality of these two methods, in addition to the determination of efficacy, cost effectiveness factors and benefit-risk estimates which are used to apply to radiation effects will be determined for nuclear medicine studies of the brain, bone, heart, liver and thyroid subsequently. The measurement techniques will then be utilized to establish guidelines for the most useful applications of the given procedure so that clinicians will be able to obtain a pretest estimate of the utility of the nuclear medicine test.

  19. Self Efficacy, Self Esteem, and Gender as Factors Predicting ...

    African Journals Online (AJOL)

    For most new students, adjusting to an unfamiliar academic setting can induce homesickness. While most studies have investigated homesickness as a negative outcome of relocation, the present study extended the literature by examining the influence of self esteem, self efficacy, and gender on homesickness among ...

  20. Teachers' Self-Efficacy vs. Parental Involvement: Prediction and Implementation

    Science.gov (United States)

    Fisher, Yael; Kostelitz, Yifat

    2015-01-01

    This research examines the influence of teachers' views regarding parental involvement on their perception of self-efficacy. Data were collected from a sample of 319 Israeli elementary schools teachers. A path analysis procedure was employed to test the mediating effect of personal background and organizational variables and perceived parental…

  1. Research Design and the Predictive Power of Measures of Self-Efficacy

    Science.gov (United States)

    Moriarty, Beverley

    2014-01-01

    The purpose of this enquiry was to examine how research design impacts on the predictive power of measures of self-efficacy. Three cautions for designing research into self-efficacy drawn from the seminal work of Albert Bandura (1986) and a further caution proposed by the current author together form the analytical framework for this enquiry. For…

  2. Ideal Teacher Behaviors: Student Motivation and Self-Efficacy Predict Preferences

    Science.gov (United States)

    Komarraju, Meera

    2013-01-01

    Differences in students' academic self-efficacy and motivation were examined in predicting preferred teacher traits. Undergraduates (261) completed the Teaching Behavior Checklist, Academic Self-Concept scale, and Academic Motivation scale. Hierarchical regression analyses indicated that academic self-efficacy and extrinsic motivation explained…

  3. Imaging drugs with and without clinical analgesic efficacy.

    Science.gov (United States)

    Upadhyay, Jaymin; Anderson, Julie; Schwarz, Adam J; Coimbra, Alexandre; Baumgartner, Richard; Pendse, G; George, Edward; Nutile, Lauren; Wallin, Diana; Bishop, James; Neni, Saujanya; Maier, Gary; Iyengar, Smriti; Evelhoch, Jeffery L; Bleakman, David; Hargreaves, Richard; Becerra, Lino; Borsook, David

    2011-12-01

    The behavioral response to pain is driven by sensory and affective components, each of which is mediated by the CNS. Subjective pain ratings are used as readouts when appraising potential analgesics; however, pain ratings alone cannot enable a characterization of CNS pain circuitry during pain processing or how this circuitry is modulated pharmacologically. Having a more objective readout of potential analgesic effects may allow improved understanding and detection of pharmacological efficacy for pain. The pharmacological/functional magnetic resonance imaging (phMRI/fMRI) methodology can be used to objectively evaluate drug action on the CNS. In this context, we aimed to evaluate two drugs that had been developed as analgesics: one that is efficacious for pain (buprenorphine (BUP)) and one that failed as an analgesic in clinical trials aprepitant (APREP). Using phMRI, we observed that activation induced solely by BUP was present in regions with μ-opioid receptors, whereas APREP-induced activation was seen in regions expressing NK(1) receptors. However, significant pharmacological modulation of functional connectivity in pain-processing pathways was only observed following BUP administration. By implementing an evoked pain fMRI paradigm, these drugs could also be differentiated by comparing the respective fMRI signals in CNS circuits mediating sensory and affective components of pain. We report a correlation of functional connectivity and evoked pain fMRI measures with pain ratings as well as peak drug concentration. This investigation demonstrates how CNS-acting drugs can be compared, and how the phMRI/fMRI methodology may be used with conventional measures to better evaluate candidate analgesics in small subject cohorts.

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

    Directory of Open Access Journals (Sweden)

    Klein P

    2018-01-01

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

  5. Clinical efficacy of pranoprofen and sodium hyaluronate for dry eye

    Directory of Open Access Journals (Sweden)

    Hong-Chao Hou

    2016-01-01

    Full Text Available AIM:To observe the clinical efficacy of pranoprofen and sodium hyaluronate for dry eye, and to provide the reference for clinical treatment of dry eye. METHODS: From January 2012 to January 2015 inour hospital, 106 patients with dry eye were tested and observed. In accordance with the number table, patients were divided into observation group and control group, 53 patients in the control group using conventional treatment plus single sodium hyaluronate eye drops, observation group using pranoprofen combined sodium hyaluronate eye drops, besides conventional treatment. Clinical outcomes between the two groups before and after treatments, dry eye score, fluorescein staining score, Schirmer I test and tear film break up time(BUTwere observed and analyzed. RESULTS:The effective rates of the two groups were 94.3%(50/53and 84.9%(45/53. Dry eye score of observation group before and after treatment were 3.24±0.52 and 0.32±0.06points, those of the control group were 3.26±0.48 and 0.75±0.24points. BUT of the experimental group before and after treatments were 5.67±3.052 and 12.95±2.865s, those of the control group were 6.23±2.985 and 9.85±2.714s.The differences between the two groups on the indicators above were statistically significant(PCONCLUSION: The combination of pranoprofen and sodium hyaluronate for the treatment of dry eye is effective, with high security and water holding capacity, which can improve the symptoms of dry eye and the patients' life quality.

  6. Combined baseline and one-month changes in big endothelin-1 and brain natriuretic peptide plasma concentrations predict clinical outcomes in patients with left ventricular dysfunction after acute myocardial infarction: Insights from the Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study (EPHESUS) study.

    Science.gov (United States)

    Olivier, A; Girerd, N; Michel, J B; Ketelslegers, J M; Fay, R; Vincent, J; Bramlage, P; Pitt, B; Zannad, F; Rossignol, P

    2017-08-15

    Increased levels of neuro-hormonal biomarkers predict poor prognosis in patients with acute myocardial infarction (AMI) complicated by left ventricular systolic dysfunction (LVSD). The predictive value of repeated (one-month interval) brain natriuretic peptides (BNP) and big-endothelin 1 (BigET-1) measurements were investigated in patients with LVSD after AMI. In a sub-study of the Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study (EPHESUS trial), BNP and BigET-1 were measured at baseline and at 1month in 476 patients. When included in the same Cox regression model, baseline BNP (p=0.0003) and BigET-1 (p=0.026) as well as the relative changes (after 1month) from baseline in BNP (p=0.049) and BigET-1 (p=0.045) were predictive of the composite of cardiovascular death or hospitalization for worsening heart failure. Adding baseline and changes in BigET-1 to baseline and changes in BNP led to a significant increase in prognostic reclassification as assessed by integrated discrimination improvement index (5.0%, p=0.01 for the primary endpoint). Both increased baseline and changes after one month in BigET-1 concentrations were shown to be associated with adverse clinical outcomes, independently from BNP baseline levels and one month changes, in patients after recent AMI complicated with LVSD. This novel result may be of clinical interest since such combined biomarker assessment could improve risk stratification and open new avenues for biomarker-guided targeted therapies. In the present study, we report for the first time in a population of patients with reduced LVEF after AMI and signs or symptoms of congestive HF, that increased baseline values of BNP and BigET-1 as well as a further rise of these markers over the first month after AMI, were independently predictive of future cardiovascular events. This approach may therefore be of clinical interest with the potential of improving risk stratification after AMI with reduced LVEF while

  7. Nanoreporter PET predicts the efficacy of anti-cancer nanotherapy

    NARCIS (Netherlands)

    Pérez-Medina, Carlos; Abdel-Atti, Dalya; Tang, Jun; Zhao, Yiming; Fayad, Zahi A.; Lewis, Jason S.; Mulder, Willem J. M.; Reiner, Thomas

    2016-01-01

    The application of nanoparticle drug formulations, such as nanoliposomal doxorubicin (Doxil), is increasingly integrated in clinical cancer care. Despite nanomedicine's remarkable potential and growth over the last three decades, its clinical benefits for cancer patients vary. Here we report a

  8. Using the knowledge-and-appraisal personality architecture to predict self-efficacy within individual persons.

    Science.gov (United States)

    Wise, James B

    2008-10-01

    The knowledge-and-appraisal personality architecture has potential as a theoretical framework for understanding the formation of self-efficacy in individuals. Two patterns were observed within 14 of 17 individual persons: a pattern of strong self-efficacy was displayed across outdoor recreation activities for which a self-descriptive attribute was viewed as an asset to successful performances, and a pattern of relatively weak self-efficacy was observed across outdoor recreation activities for which the same attribute was considered a hindrance to performances. Although the theory predicts self-efficacy within individuals, more research is needed to assess why the theory is not accurate in all cases.

  9. Uterine arterial embolization for uterine leiomyoma: efficacy and clinical outcome

    International Nuclear Information System (INIS)

    Park, Jeong Seon; Lee, Do Yon; Kim, Yong Tae; Park, Ki Hyun; Park, Yong Won; Cho, Jae Sung; Kim, Myung Jun; Won, Je Hwan; Kang, Byung Chul

    1999-01-01

    To determine the efficacy and clinical outcome of uterine arterial embolization as a new approach to the management of uterine leiomyomas. Uterine arterial embolization was performed in 21 patients aged 26-62(mean, 42) years. Twenty of these had menorrhagia, dysmenorrhea, and mass-related symptoms (low abdominal discomfort, backache, urinary frequency, etc.) and one was diagnosed incidentally. Bilateral uterine arteries were selected individually and polyvinyl alcohol and/or gelfoam was used as an embolic material. Nineteen patients were followed up after embolization. Seventeen (89.5 %)reported satisfactory improvement of symptoms and follow-up sonography three months later showed a 58.5 % reduction in mean myoma volume. In 17 patients (89.5 %), the menstrual cycle returned to normal. All patients experienced pain after the procedure and other complications were vaginal bleeding (26.3 %) and fever (23.8 %). Uterine arterial embolization represents a new approach to the management of uterine leiomyoma-related symptoms. Further investigations and long-term follow-up are, however, enquired

  10. Uterine arterial embolization for uterine leiomyoma: efficacy and clinical outcome

    Energy Technology Data Exchange (ETDEWEB)

    Park, Jeong Seon; Lee, Do Yon; Kim, Yong Tae; Park, Ki Hyun; Park, Yong Won; Cho, Jae Sung; Kim, Myung Jun [Yonsei Univ. College of Medicine, Seoul (Korea, Republic of); Won, Je Hwan [Ajou Univ. College of Medicine, Suwon (Korea, Republic of); Kang, Byung Chul [Ewha Womans Univ. College of Medicine, Seoul (Korea, Republic of)

    1999-09-01

    To determine the efficacy and clinical outcome of uterine arterial embolization as a new approach to the management of uterine leiomyomas. Uterine arterial embolization was performed in 21 patients aged 26-62(mean, 42) years. Twenty of these had menorrhagia, dysmenorrhea, and mass-related symptoms (low abdominal discomfort, backache, urinary frequency, etc.) and one was diagnosed incidentally. Bilateral uterine arteries were selected individually and polyvinyl alcohol and/or gelfoam was used as an embolic material. Nineteen patients were followed up after embolization. Seventeen (89.5 %)reported satisfactory improvement of symptoms and follow-up sonography three months later showed a 58.5 % reduction in mean myoma volume. In 17 patients (89.5 %), the menstrual cycle returned to normal. All patients experienced pain after the procedure and other complications were vaginal bleeding (26.3 %) and fever (23.8 %). Uterine arterial embolization represents a new approach to the management of uterine leiomyoma-related symptoms. Further investigations and long-term follow-up are, however, enquired.

  11. Physical stability and clinical efficacy of Crocodylus niloticus oil lotion

    Directory of Open Access Journals (Sweden)

    Telanie Venter

    Full Text Available ABSTRACT The stability and the anti-ageing, skin hydrating and anti-erythema effects of a commercialized Crocodylus niloticus Laurenti, 1768, Crocodylidae, oil lotion was determined. The lotion was stored at controlled conditions over six months during which several stability tests were performed. For the clinical efficacy studies lotion was applied on volar forearm skin (female volunteers and compared to a liquid paraffin-containing reference product. Skin hydrating and anti-ageing effects were determined with a Corneometer®, Cutometer® and Visioscan®, following single (3 h and multiple applications (12 weeks. The Vapometer® and Mexameter® were utilized to determine this lotion's anti-erythema effects on sodium lauryl sulfate irritated skin. The lotion demonstrated good stability over 6 months. The reference product increased skin hydration and decreased skin wrinkles to a larger extent than the C. niloticus lotion after a single application, whereas the C. niloticus lotion decreased skin scaliness better than the reference product. During the long-term study, the reference product overall increased skin hydration more than the C. niloticus lotion, whereas C. niloticus lotion increased skin elasticity to a larger extent than the reference product. C. niloticus lotion increased skin wrinkles and decreased skin scaliness over 12 weeks. Compared to non-treated, irritated skin, C. niloticus lotion demonstrated some potential anti-inflammatory characteristics.

  12. Gabapentin enacarbil – clinical efficacy in restless legs syndrome

    Directory of Open Access Journals (Sweden)

    Pinky Agarwal

    2010-04-01

    Full Text Available Pinky Agarwal1, Alida Griffith1, Henry R Costantino2, Narendra Vaish31Booth Gardner Parkinson’s Center, Kirkland, WA, USA; 2Costantino Consulting, Woodinville, WA, USA; 3Kirkland, WA, USAAbstract: Restless legs syndrome (RLS is a sleep-related movement disorder commonly involving an unpleasant urge to move the limbs, typically the legs. Dopaminergic agents represent the first-line therapy for RLS; however, long-term use of such drugs results in worsening symptoms due to “augmentation” or other adverse events. Gabapentin, an analog of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA, is an anticonvulsant/analgesic agent. Gabapentin is only mildly effective in relieving RLS symptoms, perhaps a result of its poor absorption from the gastrointestinal (GI tract. Gabapentin enacarbil is a prodrug of gabapentin specifically designed to enhance absorption via the GI tract, and hence provide improved circulating levels of gabapentin on metabolism. Clinical trials to date have demonstrated favorable safety and (compared to traditional gabapentin improved pharmacokinetics and efficacy in treating RLS symptoms. Thus, gabapentin enacarbil may prove to be a useful drug in treating RLS. An application of gabapentin enacarbil for treatment of RLS is currently pending with FDA for approval.Keywords: restless legs syndrome, gabapentin enacarbil, movement disorder

  13. Clinical Efficacy of Piracetam on Breath Holding Spells in Children

    Directory of Open Access Journals (Sweden)

    F. Ashrafzadeh

    2004-07-01

    Full Text Available Breath holding spells (BHS is a type of syncope in children , most commonly encontered in the early years of life. Although these athacks don't damage the brain , if these are frequent or prolonged cause , parents frighten , so physician should intervent. In this study we evaluated clinical efficacy of piracetam on B.H.S of children in Mashhad Ghaem Hospital during 2001-2002.In this double blind placebo control study , piracetam or placebo on a randomized basis was administered to children with 40 mg/kg/day in 2 divided doses for 2 months. From the 41 children that were enrolled , 21 cases received piracetam and 20 cases received placebo. Parents denoted the numbers of spells two months before and two months after taking drug. Control of breath holding spells were observed in 90.5% of patients in the group taking piracetam as compared with 40% in the group taking placebo (P = 0.002. Of the all patients 10 cases had iron deficiency anemia so they had taken elemental Fe too. The side effects were the same in these two groups. The results of this study indicated that piracetam was efficient for the treatment of children with B.H.S without greater incidence adverse effects than placebo.

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

    Directory of Open Access Journals (Sweden)

    Seithikurippu R. Pandi-Perumal

    2011-01-01

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

  15. Clinical efficacy of entecavir in treatment of hepatogenous diabetes

    Directory of Open Access Journals (Sweden)

    GOU Wei

    2013-06-01

    Full Text Available ObjectiveTo observe the clinical efficacy of entecavir in the treatment of hepatogenous diabetes (HD. MethodsA retrospective analysis was performed on the clinical data of 72 HD patients, who were divided into treatment group (n=36 and control group (n=36. Both groups were given diabetic diet and received liver-protecting treatment, symptomatic treatment, and supportive treatment. In addition, the treatment group received oral entecavir (0.5 mg once daily. The therapeutic effect was assessed after 52 weeks of treatment; the serum hepatitis B virus (HBV DNA level, liver function (alanine aminotransferase, aspartate aminotransferase, total bilirubin, and albumin, blood glucose, and glycosylated hemoglobin were measured before and after treatment. The two groups were compared by t test (for measurement data and chi-square test (for numeration data. ResultsAfter 52 weeks of treatment, 29 (80.56% of the patients in treatment group had virological response, versus 7 (19.44% of those in control group (χ2 = 18.00, P<0.01; 26 (72.22% of the patients in treatment group had liver function recovery and controlled diabetes, versus 16 (44.44% of those in control group (χ2=5.774, P<0.05. The treatment group showed significant improvements in liver function and blood glucose after treatment (P<0.05; the treatment group had significantly lower glycosylated hemoglobin and fasting blood glucose than the control group (P<0.01. ConclusionIn the treatment of HBV DNA-positive hepatitis B cirrhosis with HD, entecavir not only can effectively inhibit the replication of viral DNA and promote the recovery of liver function, but also can effectively control HD.

  16. Alflutop clinical efficacy in vertebral osteochondrosis (12-mohth study

    Directory of Open Access Journals (Sweden)

    V N Hodyrev

    2005-01-01

    Full Text Available Objective. To study clinical efficacy of aiflutop (A in lumbar osteochondrosis (LO with chronic back pain syndrome. Material and Methods. 32 pts with LO were included. 14 from them (group 1 during a year received 2 courses of A intramuscular injections (I ml/day, 30 ml total and nonsteroidal anti-inflammatory drugs (NSAIDs if necessary. 18 pts (group 2 received NSAIDs only. Clinical examination of pts was performed at the stert of the study, before and after each A course and in 3 months after the last course. Results. Pain in the spine at rest and forward bending significantly decreased in group 1 pts (p<0,05 after each A course. Full pain disappearance after the first A course was achieved in 7,1% and after the second course - in 35,7% of group I pts and was not shown in control group. Significant stepped decrease of Thomayer's test value (p<0,00l was also shown in group 1: 3,6 times decrease in comparison with baseline was achieved in 3 months after completion of treatment with A. During treatment period these pts showed 2-2,5 times increase of static and dynamic spine load (according to Vxdel chronic inability index. 42,9% of group I pts stopped NSAIDs after A treatment completion. Only 5,6% of control group pts stopped NSAIDs during follow up. A tolerability was good. It can be combined with any other medications the pts received due to comorbid diseases.

  17. Connecting clinical and actuarial prediction with rule-based methods

    NARCIS (Netherlands)

    Fokkema, M.; Smits, N.; Kelderman, H.; Penninx, B.W.J.H.

    2015-01-01

    Meta-analyses comparing the accuracy of clinical versus actuarial prediction have shown actuarial methods to outperform clinical methods, on average. However, actuarial methods are still not widely used in clinical practice, and there has been a call for the development of actuarial prediction

  18. Clinical efficacy of sublingual and subcutaneous birch pollen allergen-specific immunotherapy

    DEFF Research Database (Denmark)

    Khinchi, M S; Poulsen, Lars K.; Carat, F

    2004-01-01

    Both sublingual allergen-specific immunotherapy (SLIT) and subcutaneous immunotherapy (SCIT) have a documented clinical efficacy, but only few comparative studies have been performed.......Both sublingual allergen-specific immunotherapy (SLIT) and subcutaneous immunotherapy (SCIT) have a documented clinical efficacy, but only few comparative studies have been performed....

  19. Does the Social Working Environment Predict Beginning Teachers' Self-Efficacy and Feelings of Depression?

    Science.gov (United States)

    Devos, Christelle; Dupriez, Vincent; Paquay, Leopold

    2012-01-01

    We investigate how the social working environment predicts beginning teachers' self-efficacy and feelings of depression. Two quantitative studies are presented. The results show that the goal structure of the school culture (mastery or performance orientation) predicts both outcomes. Frequent collaborative interactions with colleagues are related…

  20. Role of Alexithymia, Anxiety, and Depression in Predicting Self-Efficacy in Academic Students

    Directory of Open Access Journals (Sweden)

    Mahbobeh Faramarzi

    2017-01-01

    Full Text Available Objective. Little research is available on the predictive factors of self-efficacy in college students. The aim of the present study is to examine the role of alexithymia, anxiety, and depression in predicting self-efficacy in academic students. Design. In a cross-sectional study, a total of 133 students at Babol University of Medical Sciences (Medicine, Dentistry, and Paramedicine participated in the study between 2014 and 2015. All participants completed the Toronto Alexithymia Scale (TAS-20, College Academic Self-Efficacy Scale (CASES, and 14 items on anxiety and depression derived from the 28 items of the General Health Questionnaire (28-GHQ. Results. Pearson correlation coefficients revealed negative significant relationships between alexithymia and the three subscales with student self-efficacy. There was no significant correlation between anxiety/depression symptoms and student self-efficacy. A backward multiple regression analysis revealed that alexithymia was a negative significant predictor of self-efficacy in academic students (B=-0.512, P<0.001. The prevalence of alexithymia was 21.8% in students. Multiple backward logistic analysis regression revealed that number of passed semesters, gender, mother’s education, father’s education, and doctoral level did not accurately predict alexithymia in college students. Conclusion. As alexithymia is prevalent in college students and affects self-efficacy and academic functioning, we suggest it should be routinely evaluated by mental physicians at universities.

  1. Role of Alexithymia, Anxiety, and Depression in Predicting Self-Efficacy in Academic Students

    Science.gov (United States)

    2017-01-01

    Objective. Little research is available on the predictive factors of self-efficacy in college students. The aim of the present study is to examine the role of alexithymia, anxiety, and depression in predicting self-efficacy in academic students. Design. In a cross-sectional study, a total of 133 students at Babol University of Medical Sciences (Medicine, Dentistry, and Paramedicine) participated in the study between 2014 and 2015. All participants completed the Toronto Alexithymia Scale (TAS-20), College Academic Self-Efficacy Scale (CASES), and 14 items on anxiety and depression derived from the 28 items of the General Health Questionnaire (28-GHQ). Results. Pearson correlation coefficients revealed negative significant relationships between alexithymia and the three subscales with student self-efficacy. There was no significant correlation between anxiety/depression symptoms and student self-efficacy. A backward multiple regression analysis revealed that alexithymia was a negative significant predictor of self-efficacy in academic students (B = −0.512, P students. Multiple backward logistic analysis regression revealed that number of passed semesters, gender, mother's education, father's education, and doctoral level did not accurately predict alexithymia in college students. Conclusion. As alexithymia is prevalent in college students and affects self-efficacy and academic functioning, we suggest it should be routinely evaluated by mental physicians at universities. PMID:28154839

  2. [Pharmacokinetics and clinical efficacy of flomoxef in neonates].

    Science.gov (United States)

    Azagami, S; Isohata, E; Takeda, S; Kin, Y; Oikawa, T; Osano, M; Shiro, H

    1991-11-01

    Clinical pharmacology and efficacy of flomoxef (FMOX) in neonates were investigated. And the following results were obtained. 1. Mean serum concentrations of FMOX at 30 minutes after administration were 24.3 micrograms/ml, 47.6 micrograms/ml, and 85.8 micrograms/ml at doses of 10 mg/kg, 20 mg/kg, and 40 mg/kg administered, respectively. 2. Mean serum half-lives of FMOX were 3.4 hours in 0-3 day-old neonates, and 2.6 hours in 4 day-old or older subjects. 3. A dose response was evident among different dose groups given 10 mg/kg, 20 mg/kg, and 40 mg/kg. 4. Urinary recovery rates of FMOX in the first 6 hours after administration ranged between 12.8 and 51.1%. 5. FMOX was effective in 7 out of 8 cases in which causative pathogens were identified. 6. Diarrhea was observed in 1 case as a side effect of the drug, but the symptom was relieved soon after the completion of the treatment. There was no case in which any abnormal laboratory results were observed. 7. FMOX has a broad spectrum of activities against Gram-positive and Gram-negative aerobes and anaerobes. It is stable against most of beta-lactamases. It was demonstrated to be highly effective in our study, and yet without any serious side effects. FMOX is therefore considered to be one of the useful agents of the first choice for the treatment of bacterial infections such as sepsis and urinary tract infections in neonates and infants.

  3. Estimation of clinical efficacy for scintigraphic images of liver, 1

    International Nuclear Information System (INIS)

    Matsumoto, Toru; Iinuma, Takeshi; Tateno, Yukio; Machida, Kikuo.

    1982-01-01

    In this study, the clinical efficacy No. 1 (diagnostic accuracy) of liver images on various liver diseases is investigated. From 8 different medical institutions the liver images of 406 cases most of which were imaged with 99mTc-phytate and confirmed for its final diagnosis by the autopsy, surgery and other techniques excluding the liver scintigraphy were collected. In order to evaluate the results of image reading, an input sheet for computer was designed to describe the confirmed diagnosis of each case. The liver images were read by 11 physicians from the 8 institutions that presented the cases and the results of reading were recorded on the work sheet for computer input. The work sheet includes abnormality in shape, size and position of the liver, position and number of SOL, and diagnosis of liver diseases, etc. By comparing the record of confirmed diagnosis and the results of image reading for individual case, various programs of analysis are being undertaken. The accuracy in detecting the SOL by means of receiver operating characteristic (ROC) analysis is presented here. The results of analysis are as follows. (1) ROC curves are rather similar in all physicians and average ROC points are TPR = 71, 80, 91%, FPR = 5, 15, 27%, respectively. (2) The SOL of size larger than 3 cm are detected more easily than those of size less than 3 cm, although number of SOL less than 3 cm is only nine cases and so variation of TPR between physicians is large. It is found that the ROC curve for many SOL of small size is almost identical to that of SOL larger than 3 cm. As to the detection of SOL larger than 3 cm, Anger camera and scanner are found to have an identical capability. (author)

  4. MRI assessment program. Consensus statement on clinical efficacy of MRI

    International Nuclear Information System (INIS)

    1998-05-01

    This consensus statement is largely based on the experience gained at the MRI units at the four hospitals which have operated scanners in the MRI program. It reflects the considered opinion of the radiologists responsible for the MRI services at those hospitals. Account has also been taken of relevant overseas data. This collection of opinion relates particularly to comparison with other imaging modalities. The specific comments will require further consideration as technical developments with MRI become available, additional experience is gained with gadolinium contrast material and additional data are obtained on the influence of MRI on patient management. MRI, at present, is used either to improve diagnostic accuracy when other tests are negative or equivocal, when there is strong clinical suspicion of disease, or to improve surgical or other management planning when the diagnosis known. In some situations (eg syringomyelia, congenital spinal disease, posterior fossa/cerebello-pontine angle tumours) it may entirely replace other tests (eg myelography, air contrast, CT) which are substantially less accurate and/or more invasive. In other situations (eg hemispheric brain tumours, lumbar disc protrusions) when other tests, such as CT, can be as accurate, MRI is not usually or initially indicated because it is currently more expensive and of limited availability. However, balanced against this is the fact that it does not expose the patient to potentially harmful ionising radiation. It is also stressed that MRI images depend on complex, widely variable and, as yet, incompletely understood parameters. There is concern that this may result in false positive diagnoses, especially where MRI is used alone as a screening test, or used as the initial test. For several reasons (availability, cost, medical and diagnostic efficacy), the specific comments on indications for MRI presented are based upon the assumption that MRI is a tertiary and complementary imaging examination

  5. Plaque removal efficacy of Colgate 360 toothbrush: A clinical study

    Directory of Open Access Journals (Sweden)

    Nageshwar Iyer

    2016-01-01

    Full Text Available Aim: The aim of this clinical study was to confirm the plaque removal efficacy of the Colgate 360 Whole Mouth Clean Toothbrush. Study Design: This was a single-center, monadic, case-controlled study with the 7 days duration. Materials and Methods: A total of eighty participants (56 male and 24 female aged between 18 and 45 years with a minimum of 20 permanent teeth (excluding the third molars without any prosthetic crowns and an initial plaque score of minimum 1.5 as determined by Modified Quigley-Hein Plaque Index (1970 participated in the study. There were two dropouts during the study duration, one male and one female. The participants were instructed to brush for 1 min, after which plaque index was recorded again. They were then instructed to brush their teeth twice a day for 1 min with the assigned toothbrush (Colgate 360 Whole Mouth Clean Toothbrush and a commercially available fluoride toothpaste for the next 7 days. On the 7 th day, all the participants were recalled for follow-up and plaque examination. The plaque index scores (pre- and post-brushing were recorded, tabulated, and analyzed statistically. Results: The mean plaque indices reduced after brushing both on day 1 and day 7. There was also a reduction in mean plaque indices from day 1 to day 7. All these reductions were statistically significant (P < 0.001. The reduction in plaque scores was independent of the gender of the participants however female participants showed lower scores as compared to male participants (P < 0.001. Conclusion: The present study demonstrated a significant reduction in plaque scores with the use of Colgate 360 Whole Mouth Clean Soft Toothbrush throughout the study period. Continued use resulted in a further significant reduction in plaque scores irrespective of the gender of participants.

  6. Quantitative sensory testing predicts pregabalin efficacy in painful chronic pancreatitis

    NARCIS (Netherlands)

    Olesen, S.S.; Graversen, C.; Bouwense, S.A.W.; Goor, H. van; Wilder-Smith, O.H.G.; Drewes, A.M.

    2013-01-01

    BACKGROUND: A major problem in pain medicine is the lack of knowledge about which treatment suits a specific patient. We tested the ability of quantitative sensory testing to predict the analgesic effect of pregabalin and placebo in patients with chronic pancreatitis. METHODS: Sixty-four patients

  7. Profiling persistent tubercule bacilli from patient sputa during therapy predicts early drug efficacy.

    Science.gov (United States)

    Honeyborne, Isobella; McHugh, Timothy D; Kuittinen, Iitu; Cichonska, Anna; Evangelopoulos, Dimitrios; Ronacher, Katharina; van Helden, Paul D; Gillespie, Stephen H; Fernandez-Reyes, Delmiro; Walzl, Gerhard; Rousu, Juho; Butcher, Philip D; Waddell, Simon J

    2016-04-07

    New treatment options are needed to maintain and improve therapy for tuberculosis, which caused the death of 1.5 million people in 2013 despite potential for an 86 % treatment success rate. A greater understanding of Mycobacterium tuberculosis (M.tb) bacilli that persist through drug therapy will aid drug development programs. Predictive biomarkers for treatment efficacy are also a research priority. Genome-wide transcriptional profiling was used to map the mRNA signatures of M.tb from the sputa of 15 patients before and 3, 7 and 14 days after the start of standard regimen drug treatment. The mRNA profiles of bacilli through the first 2 weeks of therapy reflected drug activity at 3 days with transcriptional signatures at days 7 and 14 consistent with reduced M.tb metabolic activity similar to the profile of pre-chemotherapy bacilli. These results suggest that a pre-existing drug-tolerant M.tb population dominates sputum before and after early drug treatment, and that the mRNA signature at day 3 marks the killing of a drug-sensitive sub-population of bacilli. Modelling patient indices of disease severity with bacterial gene expression patterns demonstrated that both microbiological and clinical parameters were reflected in the divergent M.tb responses and provided evidence that factors such as bacterial load and disease pathology influence the host-pathogen interplay and the phenotypic state of bacilli. Transcriptional signatures were also defined that predicted measures of early treatment success (rate of decline in bacterial load over 3 days, TB test positivity at 2 months, and bacterial load at 2 months). This study defines the transcriptional signature of M.tb bacilli that have been expectorated in sputum after two weeks of drug therapy, characterizing the phenotypic state of bacilli that persist through treatment. We demonstrate that variability in clinical manifestations of disease are detectable in bacterial sputa signatures, and that the changing M.tb m

  8. Clinical impact of concomitant immunomodulators on biologic therapy: Pharmacokinetics, immunogenicity, efficacy and safety.

    Science.gov (United States)

    Xu, Zhenhua; Davis, Hugh M; Zhou, Honghui

    2015-03-01

    Immune-mediated inflammatory diseases encompass a variety of different clinical syndromes, manifesting as either common diseases such as rheumatoid arthritis (RA), inflammatory bowel disease (IBD) and psoriasis, or rare diseases such as cryopyrin-associated periodic syndromes. The therapy for these diseases often involves the use of a wide range of drugs including nonsteroidal anti-inflammatory drugs (NSAIDs), glucocorticoids, immunomodulators, and biologic therapies. Due to the abundance of relevant clinical data, this article provides a general overview on the clinical impact of the concomitant use of immunomodulators and biologic therapies, with a focus on anti-tumor necrosis factor-α agents (anti-TNFα), for the treatment of RA and Crohn's disease (CD). Compared to biologic monotherapy, concomitant use of immunomodulators (methotrexate, azathioprine, and 6-mercaptopurine) often increases the systemic exposure of the anti-TNFα agent and decreases the formation of antibodies to the anti-TNFα agent, consequently enhancing clinical efficacy. Nevertheless, long-term combination therapy with immunomodulators and anti-TNFα agents may be associated with increased risks of serious infections and malignancies. Therefore, the determination whether combination therapy is suitable for a patient should always be based on an individualized benefit-risk evaluation. More research should be undertaken to identify and validate prognostic markers for predicting patients who would benefit the most and those who are at greater risk from combination therapy with immunomodulators and anti-TNFα agents. © 2015, The American College of Clinical Pharmacology.

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

    Science.gov (United States)

    Kim, Eun-Kyeung; Shin, Sujin

    2017-07-01

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

  10. Efficacy of a clinical stroke score in monitoring complications in ...

    African Journals Online (AJOL)

    Background: Presence of medical complications in stroke patients has been established. The efficacy of ... inpatient stroke rehabilitation have been reported .... Lancet. 1975;1:480-44. 12. Langfitt TW. Measuring outcomes from head injuries. J.

  11. Economic demand predicts addiction-like behavior and therapeutic efficacy of oxytocin in the rat

    Science.gov (United States)

    Bentzley, Brandon S.; Jhou, Thomas C.; Aston-Jones, Gary

    2014-01-01

    Development of new treatments for drug addiction will depend on high-throughput screening in animal models. However, an addiction biomarker fit for rapid testing, and useful in both humans and animals, is not currently available. Economic models are promising candidates. They offer a structured quantitative approach to modeling behavior that is mathematically identical across species, and accruing evidence indicates economic-based descriptors of human behavior may be particularly useful biomarkers of addiction severity. However, economic demand has not yet been established as a biomarker of addiction-like behavior in animals, an essential final step in linking animal and human studies of addiction through economic models. We recently developed a mathematical approach for rapidly modeling economic demand in rats trained to self-administer cocaine. We show here that economic demand, as both a spontaneous trait and induced state, predicts addiction-like behavior, including relapse propensity, drug seeking in abstinence, and compulsive (punished) drug taking. These findings confirm economic demand as a biomarker of addiction-like behavior in rats. They also support the view that excessive motivation plays an important role in addiction while extending the idea that drug dependence represents a shift from initially recreational to compulsive drug use. Finally, we found that economic demand for cocaine predicted the efficacy of a promising pharmacotherapy (oxytocin) in attenuating cocaine-seeking behaviors across individuals, demonstrating that economic measures may be used to rapidly identify the clinical utility of prospective addiction treatments. PMID:25071176

  12. Predicted Interval Plots (PIPS): A Graphical Tool for Data Monitoring of Clinical Trials.

    Science.gov (United States)

    Li, Lingling; Evans, Scott R; Uno, Hajime; Wei, L J

    2009-11-01

    Group sequential designs are often used in clinical trials to evaluate efficacy and/or futility. Many methods have been developed for different types of endpoints and scenarios. However, few of these methods convey information regarding effect sizes (e.g., treatment differences) and none uses prediction to convey information regarding potential effect size estimates and associated precision, with trial continuation. To address these limitations, Evans et al. (2007) proposed to use prediction and predicted intervals as a flexible and practical tool for quantitative monitoring of clinical trials. In this article, we reaffirm the importance and usefulness of this innovative approach and introduce a graphical summary, predicted interval plots (PIPS), to display the information obtained in the prediction process in a straightforward yet comprehensive manner. We outline the construction of PIPS and apply this method in two examples. The results and the interpretations of the PIPS are discussed.

  13. Interprofessional clinical training improves self-efficacy of health care students

    DEFF Research Database (Denmark)

    Nørgaard, Birgitte; Draborg, Eva; Vestergaard, Poul Erik

    2013-01-01

    study (ICS) unit including students from nursing, medicine, physiotherapy, occupational therapy, laboratory technology and radiography. Data on students' perceived self-efficacy were collected through web-based questionnaires. Aspects of self-efficacy measured were: (1) collaboration with other...... teamwork. The aim of this study was to assess the impact of an interprofessional training programme on students' perceived self-efficacy. Methods: A quasi-experimental study with an intervention group (239 students) and a control group (405 students). The intervention was an interprofessional clinical...... students' perception of self-efficacy more than traditional clinical training....

  14. Self-efficacy, pain, and quadriceps capacity at baseline predict changes in mobility performance over 2 years in women with knee osteoarthritis.

    Science.gov (United States)

    Brisson, Nicholas M; Gatti, Anthony A; Stratford, Paul W; Maly, Monica R

    2018-02-01

    This study examined the extent to which baseline measures of quadriceps strength, quadriceps power, knee pain and self-efficacy for functional tasks, and their interactions, predicted 2-year changes in mobility performance (walking, stair ascent, stair descent) in women with knee osteoarthritis. We hypothesized that lesser strength, power and self-efficacy, and higher pain at baseline would each be independently associated with reduced mobility over 2 years, and each of pain and self-efficacy would interact with strength and power in predicting 2-year change in stair-climbing performance. This was a longitudinal, observational study of women with clinical knee osteoarthritis. At baseline and follow-up, mobility was assessed with the Six-Minute Walk Test, and stair ascent and descent tasks. Quadriceps strength and power, knee pain, and self-efficacy for functional tasks were also collected at baseline. Multiple linear regression examined the extent to which 2-year changes in mobility performances were predicted by baseline strength, power, pain, and self-efficacy, after adjusting for covariates. Data were analyzed for 37 women with knee osteoarthritis over 2 years. Lower baseline self-efficacy predicted decreased walking (β = 1.783; p = 0.030) and stair ascent (β = -0.054; p baseline pain intensity/frequency predicted decreased walking performance (β = 1.526; p = 0.002). Lower quadriceps strength (β = 0.051; p = 0.015) and power (β = 0.022; p = 0.022) interacted with lesser self-efficacy to predict worsening stair ascent performance. Strategies to sustain or improve mobility in women with knee osteoarthritis must focus on controlling pain and boosting self-efficacy. In those with worse self-efficacy, developing knee muscle capacity is an important target.

  15. Quantifying the Impact of Natural Immunity on Rotavirus Vaccine Efficacy Estimates: A Clinical Trial in Dhaka, Bangladesh (PROVIDE) and a Simulation Study.

    Science.gov (United States)

    Rogawski, Elizabeth T; Platts-Mills, James A; Colgate, E Ross; Haque, Rashidul; Zaman, K; Petri, William A; Kirkpatrick, Beth D

    2018-03-05

    The low efficacy of rotavirus vaccines in clinical trials performed in low-resource settings may be partially explained by acquired immunity from natural exposure, especially in settings with high disease incidence. In a clinical trial of monovalent rotavirus vaccine in Bangladesh, we compared the original per-protocol efficacy estimate to efficacy derived from a recurrent events survival model in which children were considered naturally exposed and potentially immune after their first rotavirus diarrhea (RVD) episode. We then simulated trial cohorts to estimate the expected impact of prior exposure on efficacy estimates for varying rotavirus incidence rates and vaccine efficacies. Accounting for natural immunity increased the per-protocol vaccine efficacy estimate against severe RVD from 63.1% (95% confidence interval [CI], 33.0%-79.7%) to 70.2% (95% CI, 44.5%-84.0%) in the postvaccination period, and original year 2 efficacy was underestimated by 14%. The simulations demonstrated that this expected impact increases linearly with RVD incidence, will be greatest for vaccine efficacies near 50%, and can reach 20% in settings with high incidence and low efficacy. High rotavirus incidence leads to predictably lower vaccine efficacy estimates due to the acquisition of natural immunity in unvaccinated children, and this phenomenon should be considered when comparing efficacy estimates across settings. NCT01375647.

  16. Dark Triad Personality and Wisdom in Prediction of Students' Academic Self-Efficacy

    Directory of Open Access Journals (Sweden)

    Sajjad Saadat

    2018-01-01

    Full Text Available Introduction: A number of studies have argued that students' academic self-efficacy is affected by various factors. This study investigates the role of the dark triad personality and wisdom on the Iranian students' academic self-efficacy. Methods: In this correlational study, 177 (84 female and 93 male students of the University of Isfahan aged 18-54 years old (M = 23.1, SD = 4.9 were selected. Total academic mean range of the participants was 10 to 20 (M = 16.4, SD = 1.6. Participants completed the College Academic Self-Efficacy Scale, The Dark Triad Dirty Dozen, and Three-dimensional wisdom scales. Results: Results showed that there was a negative relationship between the variables of Machiavellianism and psychopathy and academic self-efficacy; inversely, there was a positive relationship between variables of cognitive and reflective wisdom and academic self-efficacy. Reflective wisdom, narcissism, and Machiavellianism predicted 0.17% of the self-efficacy. Conclusion: The results of the present study supported the importance of the dark triad personality and wisdom, as the variables, which were able to predict the academic self-efficacy of the students.

  17. Allopregnanolone preclinical acute pharmacokinetic and pharmacodynamic studies to predict tolerability and efficacy for Alzheimer's disease.

    Directory of Open Access Journals (Sweden)

    Ronald W Irwin

    /kg. The predicted MTD in human female is 0.37mg/kg. In male rats the NOAEL and MTD were less than those determined for female. Outcomes of these PK/PD studies predict a safe and efficacious dose range for initial clinical trials of allopregnanolone for Alzheimer's disease. These findings have translational relevance to multiple neurodegenerative conditions.

  18. Improved nucleic acid descriptors for siRNA efficacy prediction.

    Science.gov (United States)

    Sciabola, Simone; Cao, Qing; Orozco, Modesto; Faustino, Ignacio; Stanton, Robert V

    2013-02-01

    Although considerable progress has been made recently in understanding how gene silencing is mediated by the RNAi pathway, the rational design of effective sequences is still a challenging task. In this article, we demonstrate that including three-dimensional descriptors improved the discrimination between active and inactive small interfering RNAs (siRNAs) in a statistical model. Five descriptor types were used: (i) nucleotide position along the siRNA sequence, (ii) nucleotide composition in terms of presence/absence of specific combinations of di- and trinucleotides, (iii) nucleotide interactions by means of a modified auto- and cross-covariance function, (iv) nucleotide thermodynamic stability derived by the nearest neighbor model representation and (v) nucleic acid structure flexibility. The duplex flexibility descriptors are derived from extended molecular dynamics simulations, which are able to describe the sequence-dependent elastic properties of RNA duplexes, even for non-standard oligonucleotides. The matrix of descriptors was analysed using three statistical packages in R (partial least squares, random forest, and support vector machine), and the most predictive model was implemented in a modeling tool we have made publicly available through SourceForge. Our implementation of new RNA descriptors coupled with appropriate statistical algorithms resulted in improved model performance for the selection of siRNA candidates when compared with publicly available siRNA prediction tools and previously published test sets. Additional validation studies based on in-house RNA interference projects confirmed the robustness of the scoring procedure in prospective studies.

  19. [Anatomic rationale for clinical efficacy of intraosseous mental nerve anesthesia].

    Science.gov (United States)

    Rabinovich, S A; Vasil'ev, Yu L; Kuzin, A N

    2018-01-01

    The aim of the study was to prove the anatomical and clinical effectiveness of the modified anesthesia of mental nerve. The effectiveness of conductive anesthesia near the mental foramen was objectively evaluated using the electric pulp test (EPT) in 100 volunteers of both sexes, aged 35-43 years. Wet anterior mandible preparations obtained from 350 cadavers aged 18-74 years were also studied. EPT value after local mental anesthesia conducted according to Malamed C. using 4% articain solution of local anesthetic with vasoconstrictor concentration of 1:200.000 after 2 minutes was 93±0.82 mA, after 4 minutes - 188±1.26 mA. Yield variability indicators of intraosseous mental nerve anesthesia was slightly higher varying from 94.11 mA to 96.61 mA after 2 minutes and from 197.4 to 199.92 mA after 4 minutes survey. The study showed the efficiency and predictability of intraosseous anesthesia of the mental nerve.

  20. Clinical Predictive Modeling Development and Deployment through FHIR Web Services.

    Science.gov (United States)

    Khalilia, Mohammed; Choi, Myung; Henderson, Amelia; Iyengar, Sneha; Braunstein, Mark; Sun, Jimeng

    2015-01-01

    Clinical predictive modeling involves two challenging tasks: model development and model deployment. In this paper we demonstrate a software architecture for developing and deploying clinical predictive models using web services via the Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR) standard. The services enable model development using electronic health records (EHRs) stored in OMOP CDM databases and model deployment for scoring individual patients through FHIR resources. The MIMIC2 ICU dataset and a synthetic outpatient dataset were transformed into OMOP CDM databases for predictive model development. The resulting predictive models are deployed as FHIR resources, which receive requests of patient information, perform prediction against the deployed predictive model and respond with prediction scores. To assess the practicality of this approach we evaluated the response and prediction time of the FHIR modeling web services. We found the system to be reasonably fast with one second total response time per patient prediction.

  1. Open Access Platforms in Spinal Cord Injury: Existing Clinical Trial Data to Predict and Improve Outcomes.

    Science.gov (United States)

    Kramer, John L K; Geisler, Fred; Ramer, Leanne; Plunet, Ward; Cragg, Jacquelyn J

    2017-05-01

    Recovery from acute spinal cord injury (SCI) is characterized by extensive heterogeneity, resulting in uncertain prognosis. Reliable prediction of recovery in the acute phase benefits patients and their families directly, as well as improves the likelihood of detecting efficacy in clinical trials. This issue of heterogeneity is not unique to SCI. In fields such as traumatic brain injury, Parkinson's disease, and amyotrophic lateral sclerosis, one approach to understand variability in recovery has been to make clinical trial data widely available to the greater research community. We contend that the SCI community should adopt a similar approach in providing open access clinical trial data.

  2. [Usefulness of clinical prediction rules for ruling out deep vein thrombosis in a hospital emergency department].

    Science.gov (United States)

    Rosa-Jiménez, Francisco; Rosa-Jiménez, Ascensión; Lozano-Rodríguez, Aquiles; Santoro-Martínez, María Del Carmen; Duro-López, María Del Carmen; Carreras-Álvarez de Cienfuegos, Amelia

    2015-01-01

    To compare the efficacy of the most familiar clinical prediction rules in combination with D-dimer testing to rule out a diagnosis of deep vein thrombosis (DVT) in a hospital emergency department. Retrospective cross-sectional analysis of the case records of all patients attending a hospital emergency department with suspected lower-limb DVT between 1998 and 2002. Ten clinical prediction scores were calculated and D-dimer levels were available for all patients. The gold standard was ultrasound diagnosis of DVT by an independent radiologist who was blinded to clinical records. For each prediction rule, we analyzed the effectiveness of the prediction strategy defined by "low clinical probability and negative D-dimer level" against the ultrasound diagnosis. A total of 861 case records were reviewed and 577 cases were selected; the mean (SD) age was 66.7 (14.2) years. DVT was diagnosed in 145 patients (25.1%). Only the Wells clinical prediction rule and 4 other models had a false negative rate under 2%. The Wells criteria and the score published by Johanning and colleagues identified higher percentages of cases (15.6% and 11.6%, respectively). This study shows that several clinical prediction rules can be safely used in the emergency department, although none of them have proven more effective than the Wells criteria.

  3. Bridging the Gap Between Science and Clinical Efficacy: Physiology, Imaging, and Modeling of Aerosols in the Lung.

    Science.gov (United States)

    Darquenne, Chantal; Fleming, John S; Katz, Ira; Martin, Andrew R; Schroeter, Jeffry; Usmani, Omar S; Venegas, Jose; Schmid, Otmar

    2016-04-01

    Development of a new drug for the treatment of lung disease is a complex and time consuming process involving numerous disciplines of basic and applied sciences. During the 2015 Congress of the International Society for Aerosols in Medicine, a group of experts including aerosol scientists, physiologists, modelers, imagers, and clinicians participated in a workshop aiming at bridging the gap between basic research and clinical efficacy of inhaled drugs. This publication summarizes the current consensus on the topic. It begins with a short description of basic concepts of aerosol transport and a discussion on targeting strategies of inhaled aerosols to the lungs. It is followed by a description of both computational and biological lung models, and the use of imaging techniques to determine aerosol deposition distribution (ADD) in the lung. Finally, the importance of ADD to clinical efficacy is discussed. Several gaps were identified between basic science and clinical efficacy. One gap between scientific research aimed at predicting, controlling, and measuring ADD and the clinical use of inhaled aerosols is the considerable challenge of obtaining, in a single study, accurate information describing the optimal lung regions to be targeted, the effectiveness of targeting determined from ADD, and some measure of the drug's effectiveness. Other identified gaps were the language and methodology barriers that exist among disciplines, along with the significant regulatory hurdles that need to be overcome for novel drugs and/or therapies to reach the marketplace and benefit the patient. Despite these gaps, much progress has been made in recent years to improve clinical efficacy of inhaled drugs. Also, the recent efforts by many funding agencies and industry to support multidisciplinary networks including basic science researchers, R&D scientists, and clinicians will go a long way to further reduce the gap between science and clinical efficacy.

  4. Neither Basic Life Support knowledge nor self-efficacy are predictive of skills among dental students.

    Science.gov (United States)

    Mac Giolla Phadraig, C; Ho, J D; Guerin, S; Yeoh, Y L; Mohamed Medhat, M; Doody, K; Hwang, S; Hania, M; Boggs, S; Nolan, A; Nunn, J

    2017-08-01

    Basic life support (BLS) is considered a core competence for the graduating dentist. This study aimed to measure BLS knowledge, self-efficacy and skills of undergraduate dental students in Dublin. This study consisted of a cross-sectional survey measuring BLS knowledge and self-efficacy, accompanied by a directly observed BLS skills assessment in a subsample of respondents. Data were collected in January 2014. Bivariate correlations between descriptive and outcome variables (knowledge, self-efficacy and skills) were tested using Pearson's chi-square. We included knowledge and self-efficacy as predictor variables, along with other variables showing association, into a binary logistic regression model with BLS skills as the outcome measure. One hundred and thirty-five students participated. Almost all (n = 133, 98.5%) participants had BLS training within the last 2 years. One hundred and four (77%) felt that they were capable of providing effective BLS (self-efficacy), whilst only 46 (34.1%) scored >80% of knowledge items correct. Amongst the skills (n = 85) subsample, 38.8% (n = 33) were found to pass the BLS skills assessment. Controlling for gender, age and skills assessor, the regression model did not identify a predictive relationship between knowledge or self-efficacy and BLS skills. Neither knowledge nor self-efficacy was predictive of BLS skills. Dental students had low levels of knowledge and skills in BLS. Despite this, their confidence in their ability to perform BLS was high and did not predict actual competence. There is a need for additional hands-on training, focusing on self-efficacy and BLS skills, particularly the use of AED. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  5. Gemcitabine-Based Chemotherapy in Adrenocortical Carcinoma: A Multicenter Study of Efficacy and Predictive Factors.

    Science.gov (United States)

    Henning, Judith E K; Deutschbein, Timo; Altieri, Barbara; Steinhauer, Sonja; Kircher, Stefan; Sbiera, Silviu; Wild, Vanessa; Schlötelburg, Wiebke; Kroiss, Matthias; Perotti, Paola; Rosenwald, Andreas; Berruti, Alfredo; Fassnacht, Martin; Ronchi, Cristina L

    2017-11-01

    Adrenocortical carcinoma (ACC) is rare and confers an unfavorable prognosis in advanced stages. Other than combination chemotherapy with cisplatin, etoposide, doxorubicin, and mitotane, the second- and third-line regimens are not well-established. Gemcitabine (GEM)-based chemotherapy was suggested in a phase 2 clinical trial with 28 patients. In other solid tumors, human equilibrative nucleoside transporter type 1 (hENT1) and/or ribonucleotide reductase catalytic subunit M1 (RRM1) expression have been associated with resistance to GEM. To assess the efficacy of GEM-based chemotherapy in ACC in a real-world setting and the predictive role of molecular parameters. Retrospective multicenter study. Referral centers of university hospitals. A total of 145 patients with advanced ACC were treated with GEM-based chemotherapy (132 with concomitant capecitabine). Formalin-fixed paraffin-embedded tumor material was available for 70 patients for immunohistochemistry. The main outcome measures were progression-free survival (PFS) and an objective response to GEM-based chemotherapy. The secondary objective was the predictive role of hENT1 and RRM1. The median PFS for the patient population was 12 weeks (range, 1 to 94). A partial response or stable disease was achieved in 4.9% and 25.0% of cases, with a median duration of 26.8 weeks. Treatment was generally well tolerated, with adverse events of grade 3 or 4 occurring in 11.0% of cases. No substantial effect of hENT1 and/or RRM1 expression was observed in response to GEM-based chemotherapy. GEM-based chemotherapy is a well-tolerated, but modestly active, regimen against advanced ACC. No reliable molecular predictive factors could be identified. Owing to the scarce alternative therapeutic options, GEM-based chemotherapy remains an important option for salvage treatment for advanced ACC. Copyright © 2017 Endocrine Society

  6. Clinical abdominal palpation for predicting oligohydramnios in ...

    African Journals Online (AJOL)

    with normal AFV being reassuring for expectant management, and reduced AFV a trigger for labour induction.[3] According to textbooks, clinical evidence of reduced AFV (oligohydramnios) includes ... [11,12] AFI was used as the reference.

  7. Generic substitution comparing the clinical efficacy of a generic ...

    African Journals Online (AJOL)

    Long-acting neuroleptics have become the mainstay of the long-term treatment of schizophrenia, improving compliance and thus preventing relapse. Since schizophrenia is a common condition and ... Concerns about the quality and efficacy of these drugs should be investigated. In this study, no significant differences in the ...

  8. Clinical efficacy of Rifampicin and Streptomycin in combination ...

    African Journals Online (AJOL)

    Buruli ulcer (BU) is a cutaneous neglected tropical disease caused by Mycobacterium ulcerans. Synthesizing the evidence on their efficacy of antibiotic in the management of BU can help to better define their roles, identify weaknesses and inform clinicians on relevant measures than can be used to control BU.

  9. Efficacy of the motile sperm organelle morphology examination (MSOME in predicting pregnancy after intrauterine insemination

    Directory of Open Access Journals (Sweden)

    Mauri Ana L

    2011-08-01

    Full Text Available Abstract Background Although the motile sperm organelle morphology examination (MSOME was developed merely as a selection criterion, its application as a method for classifying sperm morphology may represent an improvement in the evaluation of semen quality. The aim of this study was to determine the prognostic value of normal sperm morphology using MSOME with regard to clinical pregnancy (CP after intrauterine insemination (IUI. Methods A total of 156 IUI cycles that were performed in 111 couples were prospectively analysed. Each subject received 75 IU of recombinant FSH every second day from the third day of the cycle. Beginning on the 10th day of the cycle, follicular development was monitored by vaginal ultrasound. When one or two follicles measuring at least 17 mm were observed, recombinant hCG was administered, and IUI was performed 12-14 h and 36-40 h after hCG treatment. Prior to the IUI procedure, sperm samples were analysed by MSOME at 8400× magnification using an inverted microscope that was equipped with DIC/Nomarski differential interference contrast optics. A minimum of 200 motile spermatozoa per semen sample were evaluated, and the percentage of normal spermatozoa in each sample was determined. Results Pregnancy occurred in 34 IUI cycles (CP rate per cycle: 21.8%, per patient: 30.6%. Based on the MSOME criteria, a significantly higher percentage of normal spermatozoa was found in the group of men in which the IUI cycles resulted in pregnancy (2.6+/-3.1% compared to the group that did not achieve pregnancy (1.2+/-1.7%; P = 0.019. Logistic regression showed that the percentage of normal cells in the MSOME was a determining factor for the likelihood of clinical pregnancy (OR: 1.28; 95% CI: 1.08 to 1.51; P = 0.003. The ROC curve revealed an area under the curve of 0.63 and an optimum cut-off point of 2% of normal sperm morphology. At this cut-off threshold, using the percentage of normal sperm morphology by MSOME to predict pregnancy

  10. Clinical abdominal palpation for predicting oligohydramnios in ...

    African Journals Online (AJOL)

    Objective. In view of the scarcity of ultrasound in low-resource settings, to evaluate abdominal palpation for prediction of oligohydramnios in suspected prolonged pregnancy, using the ultrasound-obtained amniotic fluid index (AFI) as a gold standard, taking into account maternal and fetal factors that may affect amniotic fluid ...

  11. Role of Alexithymia, Anxiety, and Depression in Predicting Self-Efficacy in Academic Students.

    Science.gov (United States)

    Faramarzi, Mahbobeh; Khafri, Soraya

    2017-01-01

    Objective . Little research is available on the predictive factors of self-efficacy in college students. The aim of the present study is to examine the role of alexithymia, anxiety, and depression in predicting self-efficacy in academic students. Design . In a cross-sectional study, a total of 133 students at Babol University of Medical Sciences (Medicine, Dentistry, and Paramedicine) participated in the study between 2014 and 2015. All participants completed the Toronto Alexithymia Scale (TAS-20), College Academic Self-Efficacy Scale (CASES), and 14 items on anxiety and depression derived from the 28 items of the General Health Questionnaire (28-GHQ). Results . Pearson correlation coefficients revealed negative significant relationships between alexithymia and the three subscales with student self-efficacy. There was no significant correlation between anxiety/depression symptoms and student self-efficacy. A backward multiple regression analysis revealed that alexithymia was a negative significant predictor of self-efficacy in academic students ( B = -0.512, P academic functioning, we suggest it should be routinely evaluated by mental physicians at universities.

  12. Social support and moment-to-moment changes in treatment self-efficacy in men living with HIV: Psychosocial moderators and clinical outcomes

    Science.gov (United States)

    Turan, Bulent; Fazeli, Pariya; Raper, James L.; Mugavero, Michael J.; Johnson, Mallory O.

    2016-01-01

    Objective For people living with HIV, treatment adherence self-efficacy is an important predictor of treatment adherence and therefore of clinical outcomes. Using experience sampling method (ESM), this study aimed to examine: (1) the within-person association between moment-to-moment changes in social support and HIV treatment self-efficacy; (2) the moderators of this within-person association, (3) the concordance between questionnaire and ESM measurement of treatment self-efficacy; and (4) the utility of each approach (ESM and questionnaire) in predicting adherence to medication, adherence to clinic visits, CD4 counts, and viral load. Methods 109 men living with HIV responded to the same set of ESM questions 3 times a day for 7 days via a smart phone given to them for the study. They also completed cross-sectional questionnaires and their clinic data was extracted from medical records in order to examine predictors and consequences of state and trait treatment self-efficacy. Results In within-person hierarchical linear modeling (HLM) analyses, receipt of recent social support predicted higher current ESM treatment self-efficacy. This association was stronger for individuals reporting higher avoidance coping with HIV. The correlation between ESM and questionnaire measures of treatment self-efficacy was r = .37. ESM measure of average treatment self-efficacy predicted medication adherence, visit adherence, CD4 counts, and viral load, while questionnaire-based self-efficacy did not predict these outcomes. Conclusion Interventions aimed at improving treatment adherence may target social support processes, which may improve treatment self-efficacy and adherence. PMID:27089459

  13. Efficacy and Safety of Rituximab in Children with Refractory Nephrotic Syndrome; A Multicenter Clinical Trial

    Directory of Open Access Journals (Sweden)

    Yo Han Ahn

    2014-06-01

    Conclusions: In this interim analysis of clinical trial to evaluate the efficacy and safety of RTX in children with refractory NS, RTX treatment for refractory NS was safe and effective, especially in patients with DNS.

  14. Pharmacokinetics, efficacy prediction indexes and residue depletion of antibacterial drugs.

    Directory of Open Access Journals (Sweden)

    Arturo Anadón

    2016-06-01

    Full Text Available Pharmacokinetics behaviour of the antibacterial in food producing animals, provides information on the rates of absorption and elimination, half-life in plasma and tissue, elimination pathways and metabolism. The dose and the dosing interval of the antimicrobial can be justified by considering the pharmacokinetic/pharmacodynamic (PK/PD relationship, if established, as well as the severity of the disease, whereas the number of administrations should be in line with the nature of the disease. The target population for therapy should be well defined and possible to identify under field conditions. Based on in vitro susceptibility data, and target animal PK data, an analysis for the PK/PD relationship may be used to support dose regimen selection and interpretation criteria for a clinical breakpoint. Therefore, for all antibacterials with systemic activity, the MIC data collected should be compared with the concentration of the compound at the relevant biophase following administration at the assumed therapeutic dose as recorded in the pharmacokinetic studies. Currently, the most frequently used parameters to express the PK/PD relationship are Cmax/MIC (maximum serum concentration/MIC, %T > MIC (fraction of time in which concentration exceeds MIC and AUC/MIC (area under the inhibitory concentration– time curve/MIC. Furthermore, the pharmacokinetic parameters provide the first indication of the potential for persistent residues and the tissues in which they may occur. The information on residue depletion in food-producing animals, provides the data on which MRL recommendations will be based. A critical factor in the antibacterial medication of all food-producing animals is the mandatory withdrawal period, defined as the time during which drug must not be administered prior to the slaughter of the animal for consumption. The withdrawal period is an integral part of the regulatory authorities’ approval process and is designed to ensure that no

  15. The Roles of Life Satisfaction, Teaching Efficacy, and Self-Esteem in Predicting Teachers' Job Satisfaction

    Science.gov (United States)

    Çevik, Gülsen Büyüksahin

    2017-01-01

    The current research aims to find out the extent to which high school teachers' life satisfaction, teaching efficacy, and self-esteem predict their job satisfaction. Research participants included a total of 358 teachers (age = 38.82; Ss = 6.73; range, 22-58), 222 males (62%) and 136 females (38%), employed in 21 public high schools in the city…

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

    Directory of Open Access Journals (Sweden)

    Tat'yana Ivanovna Romantsova

    2015-11-01

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

  17. Pharmacokinetics in Drug Discovery: An Exposure-Centred Approach to Optimising and Predicting Drug Efficacy and Safety.

    Science.gov (United States)

    Reichel, Andreas; Lienau, Philip

    2016-01-01

    The role of pharmacokinetics (PK) in drug discovery is to support the optimisation of the absorption, distribution, metabolism and excretion (ADME) properties of lead compounds with the ultimate goal to attain a clinical candidate which achieves a concentration-time profile in the body that is adequate for the desired efficacy and safety profile. A thorough characterisation of the lead compounds aiming at the identification of the inherent PK liabilities also includes an early generation of PK/PD relationships linking in vitro potency and target exposure/engagement with expression of pharmacological activity (mode-of-action) and efficacy in animal studies. The chapter describes an exposure-centred approach to lead generation, lead optimisation and candidate selection and profiling that focuses on a stepwise generation of an understanding between PK/exposure and PD/efficacy relationships by capturing target exposure or surrogates thereof and cellular mode-of-action readouts in vivo. Once robust PK/PD relationship in animal PD models has been constructed, it is translated to anticipate the pharmacologically active plasma concentrations in patients and the human therapeutic dose and dosing schedule which is also based on the prediction of the PK behaviour in human as described herein. The chapter outlines how the level of confidence in the predictions increases with the level of understanding of both the PK and the PK/PD of the new chemical entities (NCE) in relation to the disease hypothesis and the ability to propose safe and efficacious doses and dosing schedules in responsive patient populations. A sound identification of potential drug metabolism and pharmacokinetics (DMPK)-related development risks allows proposing of an effective de-risking strategy for the progression of the project that is able to reduce uncertainties and to increase the probability of success during preclinical and clinical development.

  18. A clinical prediction rule for histological chorioamnionitis in preterm newborns.

    Directory of Open Access Journals (Sweden)

    Jasper V Been

    Full Text Available BACKGROUND: Histological chorioamnionitis (HC is an intrauterine inflammatory process highly associated with preterm birth and adverse neonatal outcome. HC is often clinically silent and diagnosed postnatally by placental histology. Earlier identification could facilitate treatment individualisation to improve outcome in preterm newborns. AIM: Develop a clinical prediction rule at birth for HC and HC with fetal involvement (HCF in preterm newborns. METHODS: Clinical data and placental pathology were obtained from singleton preterm newborns (gestational age ≤ 32.0 weeks born at Erasmus UMC Rotterdam from 2001 to 2003 (derivation cohort; n = 216 or Máxima MC Veldhoven from 2009 to 2010 (validation cohort; n = 206. HC and HCF prediction rules were developed with preference for high sensitivity using clinical variables available at birth. RESULTS: HC and HCF were present in 39% and 24% in the derivation cohort and in 44% and 22% in the validation cohort, respectively. HC was predicted with 87% accuracy, yielding an area under ROC curve of 0.95 (95%CI = 0.92-0.98, a positive predictive value of 80% (95%CI = 74-84%, and a negative predictive value of 93% (95%CI = 88-96%. Corresponding figures for HCF were: accuracy 83%, area under ROC curve 0.92 (95%CI = 0.88-0.96, positive predictive value 59% (95%CI = 52-62%, and negative predictive value 97% (95%CI = 93-99%. External validation expectedly resulted in some loss of test performance, preferentially affecting positive predictive rather than negative predictive values. CONCLUSION: Using a clinical prediction rule composed of clinical variables available at birth, HC and HCF could be predicted with good test characteristics in preterm newborns. Further studies should evaluate the clinical value of these rules to guide early treatment individualisation.

  19. New and Accurate Predictive Model for the Efficacy of Extracorporeal Shock Wave Therapy in Managing Patients With Chronic Plantar Fasciitis.

    Science.gov (United States)

    Yin, Mengchen; Chen, Ni; Huang, Quan; Marla, Anastasia Sulindro; Ma, Junming; Ye, Jie; Mo, Wen

    2017-12-01

    To identify factors for the outcome of a minimum clinically successful therapy and to establish a predictive model of extracorporeal shock wave therapy (ESWT) in managing patients with chronic plantar fasciitis. Randomized, controlled, prospective study. Outpatient of local medical center settings. Patients treated for symptomatic chronic plantar fasciitis between 2014 and 2016 (N=278). ESWT was performed by the principal authors to treat chronic plantar fasciitis. ESWT was administered in 3 sessions, with an interval of 2 weeks (±4d). In the low-, moderate-, and high-intensity groups, 2400 impulses total of ESWT with an energy flux density of 0.2, 0.4, and 0.6mJ/mm 2 , respectively (a rate of 8 impulses per second), were applied. The independent variables were patient age, sex, body mass index, affected side, duration of symptoms, Roles and Maudsley score, visual analog scale (VAS) score when taking first steps in the morning, edema, bone spurs, and intensity grade of ESWT. A minimal reduction of 50% in the VAS score was considered as minimum clinically successful therapy. The correlations between the achievement of minimum clinically successful therapy and independent variables were analyzed. The statistically significant factors identified were further analyzed by multivariate logistic regression, and the predictive model was established. The success rate of ESWT was 66.9%. Univariate analysis found that VAS score when taking first steps in the morning, edema, and the presence of heel spur in radiograph significantly affected the outcome of the treatment. Logistic regression drew the equation: minimum clinically successful therapy=(1+e [.011+42.807×heel spur+.109×edema+5.395×VAS score] ) -1 .The sensitivity of the predictive factors was 96.77%, 87.63%, and 86.02%, respectively. The specificity of the predictive factors was 45.65%, 42.39%, and 85.87%, respectively. The area under the curve of the predictive factors was .751, .650, and .859, respectively. The

  20. PRRT genomic signature in blood for prediction of 177Lu-octreotate efficacy.

    Science.gov (United States)

    Bodei, Lisa; Kidd, Mark S; Singh, Aviral; van der Zwan, Wouter A; Severi, Stefano; Drozdov, Ignat A; Cwikla, Jaroslaw; Baum, Richard P; Kwekkeboom, Dik J; Paganelli, Giovanni; Krenning, Eric P; Modlin, Irvin M

    2018-07-01

    Peptide receptor radionuclide therapy (PRRT) utilizes somatostatin receptor (SSR) overexpression on neuroendocrine tumors (NET) to deliver targeted radiotherapy. Intensity of uptake at imaging is considered related to efficacy but has low sensitivity. A pretreatment strategy to determine individual PRRT response remains a key unmet need. NET transcript expression in blood integrated with tumor grade provides a PRRT predictive quotient (PPQ) which stratifies PRRT "responders" from "non-responders". This study clinically validates the utility of the PPQ in NETs. The development and validation of the PPQ was undertaken in three independent 177 Lu-PRRT treated cohorts. Specificity was tested in two separate somatostatin analog-treated cohorts. Prognostic value of the marker was defined in a cohort of untreated patients. The developmental cohort included lung and gastroenteropancreatic [GEP] NETs (n = 72) from IRST Meldola, Italy. The majority were GEP (71%) and low grade (86% G1-G2). Prospective validation cohorts were from Zentralklinik Bad Berka, Germany (n = 44), and Erasmus Medical Center, Rotterdam, Netherlands (n = 42). Each cohort included predominantly well differentiated, low grade (86-95%) lung and GEP-NETs. The non-PRRT comparator cohorts included SSA cohort I, n = 28 (100% low grade, 100% GEP-NET); SSA cohort II, n = 51 (98% low grade; 76% GEP-NET); and an untreated cohort, n = 44 (64% low grade; 91% GEP-NET). Baseline evaluations included clinical information (disease status, grade, SSR) and biomarker (CgA). NET blood gene transcripts (n = 8: growth factor signaling and metabolism) were measured pre-therapy and integrated with tumor Ki67 using a logistic regression model. This provided a binary output: "predicted responder" (PPQ+); "predicted non-responder" (PPQ-). Treatment response was evaluated using RECIST criteria [Responder (stable, partial and complete response) vs Non-Responder)]. Sample measurement and analyses were

  1. Predictive Factors Related to the Efficacy of Golimumab in Patients with Rheumatoid Arthritis

    Directory of Open Access Journals (Sweden)

    Katsuaki Kanbe

    2015-01-01

    Full Text Available In order to investigate the predictive factors related to clinical efficacy and radiographic progression at 24 weeks by looking at the serum levels of tumor necrosis factor (TNF-α and interleukin (IL-6 including baseline characteristics in patients with rheumatoid arthritis (RA treated with golimumab, serum concentrations of TNF-α and IL-6 were analyzed every 4 weeks up to 24 weeks in 47 patients treated with golimumab. Baseline levels of the Disease Activity Score 28 C-reactive protein (DAS28-CRP and Simplified Disease Activity Index (SDAI scores were also assessed. Radiographic progression using the van der Heijde-modified Sharp (vdH-S score was assessed in 29 patients. Multiple regression analyses related to the DAS28-CRP score and delta total sharp score at 24 weeks was undertaken using the baseline characteristics of patients and serum concentrations of matrix metalloproteinase (MMP-3, TNF-α, and IL–6. The DAS28-CRP score and SDAI decreased significantly at 4 weeks up to 24 weeks compared with baseline. Serum levels of TNF-α were not changed significantly up to 24 weeks compared with baseline, but those of IL-6 decreased significantly at 4 weeks up to 8 weeks. Multiple regression analyses showed that disease duration and serum levels of MMP-3 were related significantly to the DAS28-CRP score at 24 weeks. Radiographic progression was related significantly to disease duration with regard to joint space narrowing and bone erosion. However, serum levels of TNF-α and IL-6 were not correlated significantly with the DAS28-CRP score and radiographic progression. These data suggest that decreasing serum levels of IL-6 significantly, MMP-3, and disease duration are predictive factors for RA activity in patients taking golimumab.

  2. Parental Attachment Anxiety and Avoidance Predicting Child's Anxiety and Academic Efficacy in Middle Childhood

    Directory of Open Access Journals (Sweden)

    Nebi Sümer

    2015-04-01

    Full Text Available Previous work has documented that attachment security is systematically linked with child adjustment and academic competence. This study aims to examine the associations between parents' own report of anxious and avoidant attachment and their children's report of trait anxiety and academic self-efficacy in math and Turkish literature courses. Mothers (N=1539 and fathers (N=1436 from four cities in Turkey, separately completed the measures of attachment orientations, and their children (N=1877, attending 4th and 5th grades, completed the measures of trait anxiety and academic self-concept on math and literature courses in their school. Regression analyses showed that whereas mother attachment anxiety predicted boys' trait anxiety, father attachment avoidance predicted girls' anxiety. In predicting academic self-efficacy, mother attachment avoidance predicted their son's and father attachment anxiety predicted their daughter's academic self-efficacy in both math and literature courses. Our results confirmed the importance of having a warm and secure romantic attachment between spouses in marriage, not only for their relationship satisfaction and happiness, but also for their children's emotional adjustment and academic competence.

  3. Predictive probability methods for interim monitoring in clinical trials with longitudinal outcomes.

    Science.gov (United States)

    Zhou, Ming; Tang, Qi; Lang, Lixin; Xing, Jun; Tatsuoka, Kay

    2018-04-17

    In clinical research and development, interim monitoring is critical for better decision-making and minimizing the risk of exposing patients to possible ineffective therapies. For interim futility or efficacy monitoring, predictive probability methods are widely adopted in practice. Those methods have been well studied for univariate variables. However, for longitudinal studies, predictive probability methods using univariate information from only completers may not be most efficient, and data from on-going subjects can be utilized to improve efficiency. On the other hand, leveraging information from on-going subjects could allow an interim analysis to be potentially conducted once a sufficient number of subjects reach an earlier time point. For longitudinal outcomes, we derive closed-form formulas for predictive probabilities, including Bayesian predictive probability, predictive power, and conditional power and also give closed-form solutions for predictive probability of success in a future trial and the predictive probability of success of the best dose. When predictive probabilities are used for interim monitoring, we study their distributions and discuss their analytical cutoff values or stopping boundaries that have desired operating characteristics. We show that predictive probabilities utilizing all longitudinal information are more efficient for interim monitoring than that using information from completers only. To illustrate their practical application for longitudinal data, we analyze 2 real data examples from clinical trials. Copyright © 2018 John Wiley & Sons, Ltd.

  4. Immunogenicity and Clinical Efficacy of Influenza Vaccination In Pregnancy

    Directory of Open Access Journals (Sweden)

    Alexander W Kay

    2015-06-01

    Full Text Available Pregnant women are at high risk from influenza due to disproportionate morbidity, mortality, and adverse pregnancy outcomes following infection. As such, they are classified as a high priority group for vaccination. However, changes in the maternal immune system required to accommodate the allogeneic fetus may alter the immunogenicity of influenza vaccines. A large number of studies have evaluated the safety of the influenza vaccine. Here, we will review available studies on the immunogenicity and efficacy of the influenza vaccine during pregnancy, focusing on both humoral and cellular immunity.

  5. Clinical Evaluation of the Efficacy of Arthocare Forte, A Chondro ...

    African Journals Online (AJOL)

    Aim: The aim was to assess the clinical response of bacterial plaque.induced generalized chronic periodontitis to arthocare medication, and the relationship of age and gender to the prevalence of chronic periodontal disease. Subjects and. Methods: This study was done at the Dental Surgery Clinic of the University of ...

  6. Predictive genomics: A cancer hallmark network framework for predicting tumor clinical phenotypes using genome sequencing data

    OpenAIRE

    Wang, Edwin; Zaman, Naif; Mcgee, Shauna; Milanese, Jean-Sébastien; Masoudi-Nejad, Ali; O'Connor, Maureen

    2014-01-01

    We discuss a cancer hallmark network framework for modelling genome-sequencing data to predict cancer clonal evolution and associated clinical phenotypes. Strategies of using this framework in conjunction with genome sequencing data in an attempt to predict personalized drug targets, drug resistance, and metastasis for a cancer patient, as well as cancer risks for a healthy individual are discussed. Accurate prediction of cancer clonal evolution and clinical phenotypes will have substantial i...

  7. Statistical model based gender prediction for targeted NGS clinical panels

    Directory of Open Access Journals (Sweden)

    Palani Kannan Kandavel

    2017-12-01

    The reference test dataset are being used to test the model. The sensitivity on predicting the gender has been increased from the current “genotype composition in ChrX” based approach. In addition, the prediction score given by the model can be used to evaluate the quality of clinical dataset. The higher prediction score towards its respective gender indicates the higher quality of sequenced data.

  8. Predicting the safety and efficacy of buffer therapy to raise tumour pHe: an integrative modelling study

    Science.gov (United States)

    Martin, N K; Robey, I F; Gaffney, E A; Gillies, R J; Gatenby, R A; Maini, P K

    2012-01-01

    Background: Clinical positron emission tomography imaging has demonstrated the vast majority of human cancers exhibit significantly increased glucose metabolism when compared with adjacent normal tissue, resulting in an acidic tumour microenvironment. Recent studies demonstrated reducing this acidity through systemic buffers significantly inhibits development and growth of metastases in mouse xenografts. Methods: We apply and extend a previously developed mathematical model of blood and tumour buffering to examine the impact of oral administration of bicarbonate buffer in mice, and the potential impact in humans. We recapitulate the experimentally observed tumour pHe effect of buffer therapy, testing a model prediction in vivo in mice. We parameterise the model to humans to determine the translational safety and efficacy, and predict patient subgroups who could have enhanced treatment response, and the most promising combination or alternative buffer therapies. Results: The model predicts a previously unseen potentially dangerous elevation in blood pHe resulting from bicarbonate therapy in mice, which is confirmed by our in vivo experiments. Simulations predict limited efficacy of bicarbonate, especially in humans with more aggressive cancers. We predict buffer therapy would be most effectual: in elderly patients or individuals with renal impairments; in combination with proton production inhibitors (such as dichloroacetate), renal glomular filtration rate inhibitors (such as non-steroidal anti-inflammatory drugs and angiotensin-converting enzyme inhibitors), or with an alternative buffer reagent possessing an optimal pK of 7.1–7.2. Conclusion: Our mathematical model confirms bicarbonate acts as an effective agent to raise tumour pHe, but potentially induces metabolic alkalosis at the high doses necessary for tumour pHe normalisation. We predict use in elderly patients or in combination with proton production inhibitors or buffers with a pK of 7.1–7.2 is most

  9. Predicting the safety and efficacy of buffer therapy to raise tumour pHe: an integrative modelling study.

    Science.gov (United States)

    Martin, N K; Robey, I F; Gaffney, E A; Gillies, R J; Gatenby, R A; Maini, P K

    2012-03-27

    Clinical positron emission tomography imaging has demonstrated the vast majority of human cancers exhibit significantly increased glucose metabolism when compared with adjacent normal tissue, resulting in an acidic tumour microenvironment. Recent studies demonstrated reducing this acidity through systemic buffers significantly inhibits development and growth of metastases in mouse xenografts. We apply and extend a previously developed mathematical model of blood and tumour buffering to examine the impact of oral administration of bicarbonate buffer in mice, and the potential impact in humans. We recapitulate the experimentally observed tumour pHe effect of buffer therapy, testing a model prediction in vivo in mice. We parameterise the model to humans to determine the translational safety and efficacy, and predict patient subgroups who could have enhanced treatment response, and the most promising combination or alternative buffer therapies. The model predicts a previously unseen potentially dangerous elevation in blood pHe resulting from bicarbonate therapy in mice, which is confirmed by our in vivo experiments. Simulations predict limited efficacy of bicarbonate, especially in humans with more aggressive cancers. We predict buffer therapy would be most effectual: in elderly patients or individuals with renal impairments; in combination with proton production inhibitors (such as dichloroacetate), renal glomular filtration rate inhibitors (such as non-steroidal anti-inflammatory drugs and angiotensin-converting enzyme inhibitors), or with an alternative buffer reagent possessing an optimal pK of 7.1-7.2. Our mathematical model confirms bicarbonate acts as an effective agent to raise tumour pHe, but potentially induces metabolic alkalosis at the high doses necessary for tumour pHe normalisation. We predict use in elderly patients or in combination with proton production inhibitors or buffers with a pK of 7.1-7.2 is most promising.

  10. Pharmacogenetics-based area-under-curve model can predict efficacy and adverse events from axitinib in individual patients with advanced renal cell carcinoma.

    Science.gov (United States)

    Yamamoto, Yoshiaki; Tsunedomi, Ryouichi; Fujita, Yusuke; Otori, Toru; Ohba, Mitsuyoshi; Kawai, Yoshihisa; Hirata, Hiroshi; Matsumoto, Hiroaki; Haginaka, Jun; Suzuki, Shigeo; Dahiya, Rajvir; Hamamoto, Yoshihiko; Matsuyama, Kenji; Hazama, Shoichi; Nagano, Hiroaki; Matsuyama, Hideyasu

    2018-03-30

    We investigated the relationship between axitinib pharmacogenetics and clinical efficacy/adverse events in advanced renal cell carcinoma (RCC) and established a model to predict clinical efficacy and adverse events using pharmacokinetic and gene polymorphisms related to drug metabolism and efflux in a phase II trial. We prospectively evaluated the area under the plasma concentration-time curve (AUC) of axitinib, objective response rate, and adverse events in 44 consecutive advanced RCC patients treated with axitinib. To establish a model for predicting clinical efficacy and adverse events, polymorphisms in genes including ABC transporters ( ABCB1 and ABCG2 ), UGT1A , and OR2B11 were analyzed by whole-exome sequencing, Sanger sequencing, and DNA microarray. To validate this prediction model, calculated AUC by 6 gene polymorphisms was compared with actual AUC in 16 additional consecutive patients prospectively. Actual AUC significantly correlated with the objective response rate ( P = 0.0002) and adverse events (hand-foot syndrome, P = 0.0055; and hypothyroidism, P = 0.0381). Calculated AUC significantly correlated with actual AUC ( P treatment precisely predicted actual AUC after axitinib treatment ( P = 0.0066). Our pharmacogenetics-based AUC prediction model may determine the optimal initial dose of axitinib, and thus facilitate better treatment of patients with advanced RCC.

  11. Clinical efficacy of turmeric use in gingivitis: A comprehensive review.

    Science.gov (United States)

    Stoyell, Karissa A; Mappus, Jennifer L; Gandhi, Mona A

    2016-11-01

    Gingivitis affects an estimated 80% of the population, and is characterized as the world's most predominant inflammatory periodontal disease. Without intervention, gingivitis can advance to alveolar bone loss. Therefore, the primary goal in patients suffering with gingivitis is to control plaque buildup and soft tissue inflammation. Current guidelines consider chlorhexidine as the gold standard in the prevention and treatment of gingivitis. However, negative side effects of chlorhexidine, including oral mucosal erosion, discoloration of teeth, and bitter taste, provide an opportunity for alternative medications. Turmeric, a commonly used herb, possesses anti-inflammatory, antioxidant, antibacterial, antiviral, and antifungal properties. By virtue of these properties, multiple controlled trials have been performed to investigate the efficacy of turmeric in gingivitis. The aim of this comprehensive review is to summarize and evaluate the evidence on the efficacy of turmeric as compared to chlorhexidine in the prevention and treatment of gingivitis. PubMed, MedLine (Web of Science), and EBSCO (academic search complete) were utilized as primary literature search tools. The following search strategy was used: ((turmeric OR curcumin OR curcuma) AND (gingivitis OR "gum inflammation")). Five reviewed studies show that both turmeric and chlorhexidine significantly decrease plaque index (PI) and gingival index (GI), and can therefore be used in the prevention and treatment of gingivitis. Both chlorhexidine and turmeric can be used as an adjunct to mechanical means in preventing and treating gingivitis. However, trials longer than 21 days with a greater number of patients are necessary to further evaluate the comparison between turmeric and chlorhexidine. Copyright © 2016 Elsevier Ltd. All rights reserved.

  12. Combining clinical variables to optimize prediction of antidepressant treatment outcomes.

    Science.gov (United States)

    Iniesta, Raquel; Malki, Karim; Maier, Wolfgang; Rietschel, Marcella; Mors, Ole; Hauser, Joanna; Henigsberg, Neven; Dernovsek, Mojca Zvezdana; Souery, Daniel; Stahl, Daniel; Dobson, Richard; Aitchison, Katherine J; Farmer, Anne; Lewis, Cathryn M; McGuffin, Peter; Uher, Rudolf

    2016-07-01

    The outcome of treatment with antidepressants varies markedly across people with the same diagnosis. A clinically significant prediction of outcomes could spare the frustration of trial and error approach and improve the outcomes of major depressive disorder through individualized treatment selection. It is likely that a combination of multiple predictors is needed to achieve such prediction. We used elastic net regularized regression to optimize prediction of symptom improvement and remission during treatment with escitalopram or nortriptyline and to identify contributing predictors from a range of demographic and clinical variables in 793 adults with major depressive disorder. A combination of demographic and clinical variables, with strong contributions from symptoms of depressed mood, reduced interest, decreased activity, indecisiveness, pessimism and anxiety significantly predicted treatment outcomes, explaining 5-10% of variance in symptom improvement with escitalopram. Similar combinations of variables predicted remission with area under the curve 0.72, explaining approximately 15% of variance (pseudo R(2)) in who achieves remission, with strong contributions from body mass index, appetite, interest-activity symptom dimension and anxious-somatizing depression subtype. Escitalopram-specific outcome prediction was more accurate than generic outcome prediction, and reached effect sizes that were near or above a previously established benchmark for clinical significance. Outcome prediction on the nortriptyline arm did not significantly differ from chance. These results suggest that easily obtained demographic and clinical variables can predict therapeutic response to escitalopram with clinically meaningful accuracy, suggesting a potential for individualized prescription of this antidepressant drug. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

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

    Directory of Open Access Journals (Sweden)

    Jem D. Lane

    2017-11-01

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

  14. Memory self-efficacy predicts responsiveness to inductive reasoning training in older adults.

    Science.gov (United States)

    Payne, Brennan R; Jackson, Joshua J; Hill, Patrick L; Gao, Xuefei; Roberts, Brent W; Stine-Morrow, Elizabeth A L

    2012-01-01

    In the current study, we assessed the relationship between memory self-efficacy at pretest and responsiveness to inductive reasoning training in a sample of older adults. Participants completed a measure of self-efficacy assessing beliefs about memory capacity. Participants were then randomly assigned to a waitlist control group or an inductive reasoning training intervention. Latent change score models were used to examine the moderators of change in inductive reasoning. Inductive reasoning showed clear improvements in the training group compared with the control. Within the training group, initial memory capacity beliefs significantly predicted change in inductive reasoning such that those with higher levels of capacity beliefs showed greater responsiveness to the intervention. Further analyses revealed that self-efficacy had effects on how trainees allocated time to the training materials over the course of the intervention. Results indicate that self-referential beliefs about cognitive potential may be an important factor contributing to plasticity in adulthood.

  15. Quality of Acute Psychedelic Experience Predicts Therapeutic Efficacy of Psilocybin for Treatment-Resistant Depression.

    Science.gov (United States)

    Roseman, Leor; Nutt, David J; Carhart-Harris, Robin L

    2017-01-01

    Introduction: It is a basic principle of the "psychedelic" treatment model that the quality of the acute experience mediates long-term improvements in mental health. In the present paper we sought to test this using data from a clinical trial assessing psilocybin for treatment-resistant depression (TRD). In line with previous reports, we hypothesized that the occurrence and magnitude of Oceanic Boundlessness (OBN) (sharing features with mystical-type experience) and Dread of Ego Dissolution (DED) (similar to anxiety) would predict long-term positive outcomes, whereas sensory perceptual effects would have negligible predictive value. Materials and Methods: Twenty patients with treatment resistant depression underwent treatment with psilocybin (two separate sessions: 10 and 25 mg psilocybin). The Altered States of Consciousness (ASC) questionnaire was used to assess the quality of experiences in the 25 mg psilocybin session. From the ASC, the dimensions OBN and DED were used to measure the mystical-type and challenging experiences, respectively. The Self-Reported Quick Inventory of Depressive Symptoms (QIDS-SR) at 5 weeks served as the endpoint clinical outcome measure, as in later time points some of the subjects had gone on to receive new treatments, thus confounding inferences. In a repeated measure ANOVA, Time was the within-subject factor (independent variable), with QIDS-SR as the within-subject dependent variable in baseline, 1-day, 1-week, 5-weeks. OBN and DED were independent variables. OBN-by-Time and DED-by-Time interactions were the primary outcomes of interest. Results: For the interaction of OBN and DED with Time (QIDS-SR as dependent variable), the main effect and the effects at each time point compared to baseline were all significant ( p = 0.002 and p = 0.003, respectively, for main effects), confirming our main hypothesis. Furthermore, Pearson's correlation of OBN with QIDS-SR (5 weeks) was specific compared to perceptual dimensions of the ASC ( p

  16. Quality of Acute Psychedelic Experience Predicts Therapeutic Efficacy of Psilocybin for Treatment-Resistant Depression

    Directory of Open Access Journals (Sweden)

    Leor Roseman

    2018-01-01

    Full Text Available Introduction: It is a basic principle of the “psychedelic” treatment model that the quality of the acute experience mediates long-term improvements in mental health. In the present paper we sought to test this using data from a clinical trial assessing psilocybin for treatment-resistant depression (TRD. In line with previous reports, we hypothesized that the occurrence and magnitude of Oceanic Boundlessness (OBN (sharing features with mystical-type experience and Dread of Ego Dissolution (DED (similar to anxiety would predict long-term positive outcomes, whereas sensory perceptual effects would have negligible predictive value.Materials and Methods: Twenty patients with treatment resistant depression underwent treatment with psilocybin (two separate sessions: 10 and 25 mg psilocybin. The Altered States of Consciousness (ASC questionnaire was used to assess the quality of experiences in the 25 mg psilocybin session. From the ASC, the dimensions OBN and DED were used to measure the mystical-type and challenging experiences, respectively. The Self-Reported Quick Inventory of Depressive Symptoms (QIDS-SR at 5 weeks served as the endpoint clinical outcome measure, as in later time points some of the subjects had gone on to receive new treatments, thus confounding inferences. In a repeated measure ANOVA, Time was the within-subject factor (independent variable, with QIDS-SR as the within-subject dependent variable in baseline, 1-day, 1-week, 5-weeks. OBN and DED were independent variables. OBN-by-Time and DED-by-Time interactions were the primary outcomes of interest.Results: For the interaction of OBN and DED with Time (QIDS-SR as dependent variable, the main effect and the effects at each time point compared to baseline were all significant (p = 0.002 and p = 0.003, respectively, for main effects, confirming our main hypothesis. Furthermore, Pearson's correlation of OBN with QIDS-SR (5 weeks was specific compared to perceptual dimensions of the

  17. Professional choice self-efficacy: predicting traits and personality profiles in high school students

    Directory of Open Access Journals (Sweden)

    Rodolfo Augusto Matteo Ambiel

    2016-01-01

    Full Text Available Abstract This study aimed to verify the predictive capacity of the Big Five personality factors related to professional choice self-efficacy, as well as to draw a personality profile of people with diverse self-efficacy levels. There were 308 high school students participating, from three different grades (57.5 % women, from public and private schools, average 26.64 years of age. Students completed two instruments, Escala de Autoeficácia para Escolha Profissional (Professional Choice Self-efficacy Scale and Bateria Fatorial de Personalidade (Factorial Personality Battery. Results were obtained using multiple regression analysis, analysis of variance with repeated measures profile and Cohen’s d to estimate the effect size of differences. Results showed that Extraversion, Agreeableness and Conscientiousness were the main predictors of self-efficacy. Differences from medium to large were observed between extreme groups, and Extraversion and Conscientiousness were the personality factors that better distinguish people with low and high levels of self-efficacy. Theses results partially corroborate with the hypothesis. Results were discussed based on literature and on the practical implications of the results. New studies are proposed.

  18. Clinical efficacy of radiation synovectomy in digital joint osteoarthritis

    International Nuclear Information System (INIS)

    Kampen, Willm Uwe; Hellweg, Leif; Massoudi-Nickel, Schirin; Czech, Norbert; Henze, Eberhard; Brenner, Winfried

    2005-01-01

    Radiation synovectomy was developed for local treatment of rheumatoid arthritis. In this study, the long-term efficacy of radiation synovectomy was retrospectively evaluated in patients with osteoarthritis (activated arthrosis) of the digital joints using an algofunctional score. Fifty-three digital joints in 29 patients (mean age 64.8 years) were treated by intra-articular injection of 169 Er citrate. All joints were painful despite pharmacotherapy and showed an elevated blood pool pattern in a pretherapeutic three-phase bone scan, indicative for local synovitis. The patients were asked to classify their complaints with respect to different daily manual activities on a ten-step pain scale from 1 (total disability) to 10 (lack of any impairment) prior to and after treatment, with a mean follow-up of 41 months. Local signs of osteoarthritis such as joint swelling or pain were additionally evaluated and were scored from progression of complaints to excellent improvement based on patient self-evaluation. All patients reported a pronounced improvement in their manual activities. The mean total score of 4.73±0.58 for all activities prior to treatment increased significantly to 6.79±0.47 after radiation synovectomy (p<0.05). The best results were obtained in the thumb base joints, whereas distal interphalangeal joints were frequently resistant to therapy. Radiation synovectomy is highly effective in digital joint osteoarthritis with concomitant local synovitis. (orig.)

  19. Anesthetic Efficacy in Irreversible Pulpitis: A Randomized Clinical Trial.

    Science.gov (United States)

    Allegretti, Carlos E; Sampaio, Roberta M; Horliana, Anna C R T; Armonia, Paschoal L; Rocha, Rodney G; Tortamano, Isabel Peixoto

    2016-01-01

    Inferior alveolar nerve block has a high failure rate in the treatment of mandibular posterior teeth with irreversible pulpitis. The aim of this study was to compare the anesthetic efficacy of 4% articaine, 2% lidocaine and 2% mepivacaine, all in combination with 1:100,000 epinephrine, in patients with irreversible pulpitis of permanent mandibular molars during a pulpectomy procedure. Sixty-six volunteers from the Emergency Center of the School of Dentistry, University of São Paulo, randomly received 3.6 mL of local anesthetic as a conventional inferior alveolar nerve block (IANB). The subjective signal of lip numbness, pulpal anesthesia and absence of pain during the pulpectomy procedure were evaluated respectively, by questioning the patient, stimulation using an electric pulp tester and a verbal analogue scale. All patients reported the subjective signal of lip numbness. Regarding pulpal anesthesia success as measured with the pulp tester, the success rate was respectively 68.2% for mepivacaine, 63.6% for articaine and 63.6% for lidocaine. Regarding patients who reported no pain or mild pain during the pulpectomy, the success rate was, respectively 72.7% for mepivacaine, 63.6% for articaine and 54.5% for lidocaine. These differences were not statistically significant. Neither of the solutions resulted in 100% anesthetic success in patients with irreversible pulpitis of mandibular molars.

  20. Clinical efficacy of radiation synovectomy in digital joint osteoarthritis

    Energy Technology Data Exchange (ETDEWEB)

    Kampen, Willm Uwe; Hellweg, Leif; Massoudi-Nickel, Schirin; Czech, Norbert; Henze, Eberhard [University Hospital Schleswig-Holstein, Clinic of Nuclear Medicine, Kiel (Germany); Brenner, Winfried [University Hospital Hamburg-Eppendorf, Department of Nuclear Medicine (Germany)

    2005-04-01

    Radiation synovectomy was developed for local treatment of rheumatoid arthritis. In this study, the long-term efficacy of radiation synovectomy was retrospectively evaluated in patients with osteoarthritis (activated arthrosis) of the digital joints using an algofunctional score. Fifty-three digital joints in 29 patients (mean age 64.8 years) were treated by intra-articular injection of{sup 169}Er citrate. All joints were painful despite pharmacotherapy and showed an elevated blood pool pattern in a pretherapeutic three-phase bone scan, indicative for local synovitis. The patients were asked to classify their complaints with respect to different daily manual activities on a ten-step pain scale from 1 (total disability) to 10 (lack of any impairment) prior to and after treatment, with a mean follow-up of 41 months. Local signs of osteoarthritis such as joint swelling or pain were additionally evaluated and were scored from progression of complaints to excellent improvement based on patient self-evaluation. All patients reported a pronounced improvement in their manual activities. The mean total score of 4.73{+-}0.58 for all activities prior to treatment increased significantly to 6.79{+-}0.47 after radiation synovectomy (p<0.05). The best results were obtained in the thumb base joints, whereas distal interphalangeal joints were frequently resistant to therapy. Radiation synovectomy is highly effective in digital joint osteoarthritis with concomitant local synovitis. (orig.)

  1. Preliminary study for predicting better methotrexate efficacy in Japanese patients with rheumatoid arthritis

    OpenAIRE

    Hashiguchi, Masayuki; Tsuru, Tomomi; Miyawaki, Kumika; Suzaki, Midori; Hakamata, Jun; Shimizu, Mikiko; Irie, Shin; Mochizuki, Mayumi

    2016-01-01

    Background Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by systemic inflammatory status, joint destruction, disability, and pain. Methotrexate (MTX) has been confirmed to reduce disease activity and delay or stabilize the development of bone erosions. However, major drawbacks are that patients show great interindividual variability in response to MTX and the unpredictable occurrence of side effects. A strategy for personalized MTX treatment to predict its efficacy a...

  2. Evaluation of the efficacy of six nutritional screening tools to predict malnutrition in the elderly.

    Science.gov (United States)

    Poulia, Kalliopi-Anna; Yannakoulia, Mary; Karageorgou, Dimitra; Gamaletsou, Maria; Panagiotakos, Demosthenes B; Sipsas, Nikolaos V; Zampelas, Antonis

    2012-06-01

    Malnutrition in the elderly is a multifactorial problem, more prevalent in hospitals and care homes. The absence of a gold standard in evaluating nutritional risk led us to evaluate the efficacy of six nutritional screening tools used in the elderly. Two hundred forty eight elderly patients (129 men, 119 female women, aged 75.2 ± 8.5 years) were examined. Nutritional screening was performed on admission using the following tools: Nutritional Risk Index (NRI), Geriatric Nutritional Risk Index (GNRI), Subjective Global Assessment (SGA), Mini Nutritional Assessment - Screening Form (MNA-SF), Malnutrition Universal Screening Tool (MUST) and Nutritional Risk Screening 2002 (NRS 2002). A combined index for malnutrition was also calculated. Nutritional risk and/or malnutrition varied greatly, ranging from 47.2 to 97.6%, depending on the nutritional screening tool used. MUST was the most valid screening tool (validity coefficient = 0.766, CI 95%: 0.690-0.841), while SGA was in better agreement with the combined index (κ = 0.707, p = 0.000). NRS 2002 although was the highest in sensitivity (99.4%), it was the lowest in specificity (6.1%) and positive predictive value (68.2%). MUST seem to be the most valid in the evaluation of the risk for malnutrition in the elderly upon admission to the hospital. NRS 2002 was found to overestimate nutritional risk in the elderly. Copyright © 2011 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  3. Analysis of the clinical experience with perampanel in the Moscow Region: Efficacy, tolerability, individual choice priorities

    Directory of Open Access Journals (Sweden)

    I. G. Rudakova

    2017-01-01

    Full Text Available Objective: to analyze our clinical experience with perampanel (PER, by evaluating the efficacy, tolerability, and individual choice priorities.Patients and methods. The investigation enrolled 28 patients with drug-resistant focal epilepsy; the patients' mean age was 38.3±10.7 years. The proportion of men was 46.4%; the disease duration was 8 to 33 years (mean 20.2 years. Antiepileptic drugs (AEDs were changed 7–10 times in 66% of the patients and 5–6 times in 23%. The efficacy and tolerability of AEDs and the electroclinical features of epilepsy were compared in two groups: responders and non-responders.Results and discussion. The responder and non-responder groups had a substantial preponderance of patients with frontal lobe epilepsy and diffuse epileptiform electroencephalographic (EEG patterns (80%:46% and 80%:38%, respectively; p = 0.0001, but those with temporal lobe epilepsy and isolated regional EEG patterns were 2–3 times fewer (20%: 53.8% and 20%:61.5%; p = 0.0001. Only one of 10 combinations of carbamazepine (CBM and PER was successful. Aggression, fear, and psychosis, which occurred in 5 (17.8% patients taking PER 2–6 mg/day, were the most common adverse reactions associated with its discontinuation. PER is an effective agent to overcome of drug resistance in epilepsy. The benefit of the drug is that it may be used in undifferentiated antiepileptic therapy regimens. When predicting the effects of PER, preliminary switch from CBZ to oxcarbazepine or eslicarbazepine is reasonable. 

  4. Clinical outcomes and efficacy of transforaminal lumbar endoscopic discectomy

    Directory of Open Access Journals (Sweden)

    Cezmi Çagri Türk

    2015-01-01

    Full Text Available Background: Transforaminal lumbar endoscopic discectomy (TLED is a minimally invasive procedure for removing lumbar disc herniations. This technique was initially reserved for herniations in the foraminal or extraforaminal region. This study concentrated on our experience regarding the outcomes and efficacy of TLED. Materials and Methods: A total of 105 patients were included in the study. The patients were retrospectively evaluated for demographic features, lesion levels, numbers of affected levels, visual analog scores (VASs, Oswestry disability questionnaire scale scores and MacNab pain relief scores. Results: A total of 48 female and 57 male patients aged between 25 and 64 years (mean: 41.8 years underwent TLED procedures. The majority (83% of the cases were operated on at the levels of L4-5 and L5-S1. Five patients had herniations at two levels. There were significant decreases between the preoperative VAS scores collected postoperatively at 6 months (2.3 and those collected after 1-year (2.5. Two patients were referred for microdiscectomy after TLED due to unsatisfactory pain relief on the 1 st postoperative day. The overall success rate with respect to pain relief was 90.4% (95/105. Seven patients with previous histories of open discectomy at the same level reported fair pain relief after TLED. Conclusions: Transforaminal lumbar endoscopic discectomy is a safe and effective alternative to microdiscectomy that is associated with minor tissue trauma. Herniations that involved single levels and foraminal/extraforaminal localizations were associated with better responses to TLED.

  5. CorVue algorithm efficacy to predict heart failure in real life: Unnecessary and potentially misleading information?

    Science.gov (United States)

    Palfy, Julia Anna; Benezet-Mazuecos, Juan; Milla, Juan Martinez; Iglesias, Jose Antonio; de la Vieja, Juan Jose; Sanchez-Borque, Pepa; Miracle, Angel; Rubio, Jose Manuel

    2018-06-01

    Heart failure (HF) hospitalizations have a negative impact on quality of life and imply important costs. Intrathoracic impedance (ITI) variations detected by cardiac devices have been hypothesized to predict HF hospitalizations. Although Optivol™ algorithm (Medtronic) has been widely studied, CorVue™ algorithm (St. Jude Medical) long term efficacy has not been systematically evaluated in a "real life" cohort. CorVue™ was activated in ICD/CRT-D patients to store information about ITI measures. Clinical events (new episodes of HF requiring treatment and hospitalizations) and CorVue™ data were recorded every three months. Appropriate CorVue™ detection for HF was considered if it occurred in the four prior weeks to the clinical event. 53 ICD/CRT-D (26 ICD and 27 CRT-D) patients (67±1 years-old, 79% male) were included. Device position was subcutaneous in 28 patients. At inclusion, mean LVEF was 25±7% and 27 patients (51%) were in NYHA class I, 18 (34%) class II and 8 (15%) class III. After a mean follow-up of 17±9 months, 105 ITI drops alarms were detected in 32 patients (60%). Only six alarms were appropriate (true positive) and required hospitalization. Eighteen patients (34%) presented 25 clinical episodes (12 hospitalizations and 13 ER/ambulatory treatment modifications). Nineteen of these clinical episodes (76%) remained undetected by the CorVue™ (false negative). Sensitivity of CorVue™ resulted in 24%, specificity was 70%, positive predictive value of 6% and negative predictive value of 93%. CorVue™ showed a low sensitivity to predict HF events. Therefore, routinely activation of this algorithm could generate misleading information. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  6. Update on the treatment of narcolepsy: clinical efficacy of pitolisant

    Directory of Open Access Journals (Sweden)

    Calik MW

    2017-04-01

    Full Text Available Michael W Calik1,2 1Department of Biobehavioral Health Science, 2Center for Narcolepsy, Sleep and Health Research, University of Illinois at Chicago, Chicago, IL, United States Abstract: Narcolepsy is a neurological disease that affects 1 in 2,000 individuals and is characterized by excessive daytime sleepiness (EDS. In 60–70% of individuals with narcolepsy, it is also characterized by cataplexy or a sudden loss of muscle tone that is triggered by positive or negative emotions. Narcolepsy decreases the quality of life of the afflicted individuals. Currently used drugs treat EDS alone (modafinil/armodafinil, methylphenidate, and amphetamine, cataplexy alone (“off-label” use of antidepressants, or both EDS and cataplexy (sodium oxybate. These drugs have abuse, tolerability, and adherence issues. A greater diversity of drug options is needed to treat narcolepsy. The small molecule drug, pitolisant, acts as an inverse agonist/antagonist at the H3 receptor, thus increasing histaminergic tone in the wake promoting system of the brain. Pitolisant has been studied in animal models of narcolepsy and used in clinical trials as a treatment for narcolepsy. A comprehensive search of online databases (eg, Medline, PubMed, EMBASE, the Cochrane Library Database, Ovid MEDLINE, Europe PubMed Central, EBSCOhost CINAHL, ProQuest Research Library, Google Scholar, and ClinicalTrials.gov was performed. Nonrandomized and randomized studies were included. This review focuses on the outcomes of four clinical trials of pitolisant to treat narcolepsy. These four trials show that pitolisant is an effective drug to treat EDS and cataplexy in narcolepsy. Keywords: narcolepsy, pitolisant, histamine

  7. [Immunological and clinical study on therapeutic efficacy of inosine pranobex].

    Science.gov (United States)

    Gołebiowska-Wawrzyniak, Maria; Markiewicz, Katarzyna; Kozar, Agata; Derentowicz, Piotr; Czerwińska-Kartowicz, Iwona; Jastrzebska-Janas, Krystyna; Wacławek, Jolanta; Wawrzyniak, Zbigniew M; Siwińska-Gołebiowska, Henryka

    2005-09-01

    Many studies in vitro and in vivo have shown immunomodulating and antiviral activities of inosine pranobex. The object of this research was to examine the potential beneficial effects of inosine pranobex (Groprinosin) on immune system in children with cellular immunodeficiency as a prophylaxis of recurrent infections, mainly of viral origin. 50 mg/kg b.w/day of inosine pranobex in divided doses was given to the group of 30 children aged 3-15 years for 10 days in 3 following months. Clinical and immunological investigations were done before and after the treatment. Statistically significant rise of CD3T lymphocytes number (p = 0.02) and in this CD4T lymphocytes number (p = 0.02) as well as statistically significant improvement of their function (p = 0.005) evaluated with blastic transformation method were found. These laboratory findings were parallel to clinical benefits. Control study was performed in the group of children completed by randomization and treated in the same way with garlic (Alliofil).

  8. Clinical and biochemical efficacy of diltiazem in hyperthyroidism

    International Nuclear Information System (INIS)

    Marwat, M.A.

    2008-01-01

    To evaluate the effect of diltiazem on the adrenergic manifestations of hyperthyroidism and thyroid function tests. This prospective, interventional study included 19 newly diagnosed patients (16 females, 3 males with mean age of 35.31+-0.36 years) of hyperthyroidism attending the out patient department of Institute of Radiotherapy and Nuclear Medicine, Peshawar. All patients took diltiazem 30 mg three times a day for 6 weeks. Clinical assessment was done before starting therapy and then serially after 1, 2, 4 and 6 weeks (+-3 days) using Standardized and modified hyperthyroid symptom score. Serum free T/sub 4/ measurements were done before starting diltiazem and then serially after 2, 4 and 6 weeks (+-3 days) of therapy. Following therapy with diltiazem the hyperthyroid systems core decreased significantly at 1, 2, 4 and 6 weeks of therapy. With individual values dropping from 14.42 to 12.89 pmol/L after 1 week (P 0.05). Diltiazem effectively controls the clinical manifestation of hyperthyroidism. It also causes some decline in free thyroxine levels. (author)

  9. Predictive Factors for Efficacy of Dipeptidyl Peptidase-4 Inhibitors in Patients with Type 2 Diabetes Mellitus

    Directory of Open Access Journals (Sweden)

    Shusuke Yagi

    2015-08-01

    Full Text Available BackgroundPredictive factors for the efficacy of dipeptidyl peptidase-4 (DPP-4 inhibitors for lowering glycosylated hemoglobin (HbA1c remain unclear in patients with type 2 diabetes mellitus. The aim of this study is therefore to clarify predictive factors of the efficacy of DPP-4 inhibitors for lowering HbA1c after 12 months of treatment.MethodsA total of 191 consecutive type 2 diabetic patients (male sex 55%, mean age, 68.3±35.8 years, who had been treated with DPP-4 inhibitors for 12 months, were enrolled in this study and evaluated retrospectively.ResultsAfter 12 months of DPP-4 inhibitor treatment, random blood glucose level, and HbA1c level, decreased from 167±63 to 151±49 mg/dL (P<0.01, and from 7.5%±1.3% to 6.9%±0.9% (P<0.01 respectively, without severe side effects. Multiple regression analysis showed that predictors of DPP-4 inhibitor treatment efficacy in lowering HbA1c level after 12 months were a decrease in HbA1c level after 3 months of treatment, a high baseline HbA1c level, a low baseline body mass index, and the absence of coronary artery disease.ConclusionMost suitable candidates for treatment with DPP-4 inhibitors are diabetics who are not obese and do not have coronary artery disease. In addition, long-term efficacy of DPP-4 inhibitors can be predicted by decrement of HbA1c after 3 months of treatment.

  10. The efficacy of maggot debridement therapy - a review of comparative clinical trials

    DEFF Research Database (Denmark)

    Zarchi, K.; Jemec, G.B.

    2012-01-01

    in a variety of ulcers. However, comparative clinical trials and in particular randomized controlled trials investigating the efficacy of MDT are sparse. A systematic search in the literature showed three randomized clinical trials and five non randomized studies evaluating the efficacy of sterile Lucilia......, including hydrocolloid, hydrogel and saline moistened gauze. However, the design of the studies was suboptimal, with important differences in the use of other therapies, such as compression, that may influence both debridement and healing between the compared groups, as well as inappropriately short follow...

  11. Clinical time series prediction: Toward a hierarchical dynamical system framework.

    Science.gov (United States)

    Liu, Zitao; Hauskrecht, Milos

    2015-09-01

    Developing machine learning and data mining algorithms for building temporal models of clinical time series is important for understanding of the patient condition, the dynamics of a disease, effect of various patient management interventions and clinical decision making. In this work, we propose and develop a novel hierarchical framework for modeling clinical time series data of varied length and with irregularly sampled observations. Our hierarchical dynamical system framework for modeling clinical time series combines advantages of the two temporal modeling approaches: the linear dynamical system and the Gaussian process. We model the irregularly sampled clinical time series by using multiple Gaussian process sequences in the lower level of our hierarchical framework and capture the transitions between Gaussian processes by utilizing the linear dynamical system. The experiments are conducted on the complete blood count (CBC) panel data of 1000 post-surgical cardiac patients during their hospitalization. Our framework is evaluated and compared to multiple baseline approaches in terms of the mean absolute prediction error and the absolute percentage error. We tested our framework by first learning the time series model from data for the patients in the training set, and then using it to predict future time series values for the patients in the test set. We show that our model outperforms multiple existing models in terms of its predictive accuracy. Our method achieved a 3.13% average prediction accuracy improvement on ten CBC lab time series when it was compared against the best performing baseline. A 5.25% average accuracy improvement was observed when only short-term predictions were considered. A new hierarchical dynamical system framework that lets us model irregularly sampled time series data is a promising new direction for modeling clinical time series and for improving their predictive performance. Copyright © 2014 Elsevier B.V. All rights reserved.

  12. Clinical time series prediction: towards a hierarchical dynamical system framework

    Science.gov (United States)

    Liu, Zitao; Hauskrecht, Milos

    2014-01-01

    Objective Developing machine learning and data mining algorithms for building temporal models of clinical time series is important for understanding of the patient condition, the dynamics of a disease, effect of various patient management interventions and clinical decision making. In this work, we propose and develop a novel hierarchical framework for modeling clinical time series data of varied length and with irregularly sampled observations. Materials and methods Our hierarchical dynamical system framework for modeling clinical time series combines advantages of the two temporal modeling approaches: the linear dynamical system and the Gaussian process. We model the irregularly sampled clinical time series by using multiple Gaussian process sequences in the lower level of our hierarchical framework and capture the transitions between Gaussian processes by utilizing the linear dynamical system. The experiments are conducted on the complete blood count (CBC) panel data of 1000 post-surgical cardiac patients during their hospitalization. Our framework is evaluated and compared to multiple baseline approaches in terms of the mean absolute prediction error and the absolute percentage error. Results We tested our framework by first learning the time series model from data for the patient in the training set, and then applying the model in order to predict future time series values on the patients in the test set. We show that our model outperforms multiple existing models in terms of its predictive accuracy. Our method achieved a 3.13% average prediction accuracy improvement on ten CBC lab time series when it was compared against the best performing baseline. A 5.25% average accuracy improvement was observed when only short-term predictions were considered. Conclusion A new hierarchical dynamical system framework that lets us model irregularly sampled time series data is a promising new direction for modeling clinical time series and for improving their predictive

  13. [Predictive methods versus clinical titration for the initiation of lithium therapy. A systematic review].

    Science.gov (United States)

    Geeraerts, I; Sienaert, P

    2013-01-01

    When lithium is administered, the clinician needs to know when the lithium in the patient’s blood has reached a therapeutic level. At the initiation of treatment the level is usually achieved gradually through the application of the titration method. In order to increase the efficacy of this procedure several methods for dosing lithium and for predicting lithium levels have been developed. To conduct a systematic review of the publications relating to the various methods for dosing lithium or predicting lithium levels at the initiation of therapy. We searched Medline systematically for articles published in English, French or Dutch between 1966 and April 2012 which described or studied a method for dosing lithium or for predicting the lithium level reached following a specific dosage. We screened the reference lists of relevant articles in order to locate additional papers. We found 38 lithium prediction methods, in addition to the clinical titration method. These methods can be divided into two categories: the ‘a priori’ methods and the ‘test-dose’ methods, the latter requiring the administration of a test dose of lithium. The lithium prediction methods generally achieve a therapeutic blood level faster than the clinical titration method, but none of the methods achieves convincing results. On the basis of our review, we propose that the titration method should be used as the standard method in clinical practice.

  14. Predictive value of EGFR overexpression and gene amplification on icotinib efficacy in patients with advanced esophageal squamous cell carcinoma.

    Science.gov (United States)

    Wang, Xi; Niu, Haitao; Fan, Qingxia; Lu, Ping; Ma, Changwu; Liu, Wei; Liu, Ying; Li, Weiwei; Hu, Shaoxuan; Ling, Yun; Guo, Lei; Ying, Jianming; Huang, Jing

    2016-04-26

    This study aimed to search for a molecular marker for targeted epithelial growth factor receptor (EGFR) inhibitor Icotinib by analyzing protein expression and amplification of EGFR proto-oncogene in esophageal squamous cell carcinoma (ESCC) patients.Immunohistochemistry and fluorescence in situ hybridization (FISH) was used to assess EGFR expression and gene amplification status in 193 patients with ESCC. We also examined the association between EGFR overexpression and the efficacy of a novel EGFR TKI, icotinib, in 62 ESCC patients.Of the 193 patients, 95 (49.2%) patients showed EGFR overexpression (3+), and 47(24.4%) patients harbored EGFR FISH positivity. EGFR overexpression was significantly correlated with clinical stage and lymph node metastasis (picotinib, the response rate was 17.6% for patients with high EGFR-expressing tumors, which was markedly higher than the rate (0%) for patients with low to moderate EGFR-expressing tumors (p=0.341). Furthermore, all cases responded to icotinib showed EGFR overexpression.In conclusion, our study suggests that EGFR overexpression might potentially be used in predicting the efficacy in patients treated with Icotinib. These data have implications for both clinical trial design and therapeutic strategies.

  15. The dark and bright sides of self-efficacy in predicting learning, innovative and risky performances.

    Science.gov (United States)

    Salanova, Marisa; Lorente, Laura; Martínez, Isabel M

    2012-11-01

    The objective of this study is to analyze the different role that efficacy beliefs play in the prediction of learning, innovative and risky performances. We hypothesize that high levels of efficacy beliefs in learning and innovative performances have positive consequences (i.e., better academic and innovative performance, respectively), whereas in risky performances they have negative consequences (i.e., less safety performance). To achieve this objective, three studies were conducted, 1) a two-wave longitudinal field study among 527 undergraduate students (learning setting), 2) a three-wave longitudinal lab study among 165 participants performing innovative group tasks (innovative setting), and 3) a field study among 228 construction workers (risky setting). As expected, high levels of efficacy beliefs have positive or negative consequences on performance depending on the specific settings. Unexpectedly, however, we found no time x self-efficacy interaction effect over time in learning and innovative settings. Theoretical and practical implications within the social cognitive theory of A. Bandura framework are discussed.

  16. In vitro efficacy of fosfomycin against clinical strains

    Directory of Open Access Journals (Sweden)

    Adil Karadağ

    2014-06-01

    Full Text Available Objective: Fosfomycin is an alternative drug for treatment of uncomplicated urinary tract infections. This study aimed to investigate in vitro activity of fosfomycin against ethicillinresistant Staphylococcus aureus (MRSA, methicillinresistant coagulase negative staphylococci (MRCoNS, vancomycin-resistant Enterococcus faecium (VR E. faecium, Escherichia coli, Klebsiella pneumoniae, and Enterobacter isolates Methods: Clinical isolates of MRSA, MRCoNS, E. coli, K. pneumoniae and Enterobacter spp. and VRE isolates which were isolated from rectal swaps were identified with Vitek 2 Compact (Biomeriux, France and BD Phoenix (BD USA automated systems. The Kirby-Bauer disc diffusion method was used to determine the susceptibility to fosfomycin. Results: All the MRSA (n=40, MRCoNS (n=40, and VR E. faecium (n=62 isolates were susceptible to fosfomycin. The fosfomycin susceptibility rates for E. coli, K. pneumoniae, and Enterobacter spp. were 97.5% (39 of 40, 97.3% (36 of 37, and 86.9% (20 of 23, respectively. One (2.7% isolate of K. pneumoniae and three (13.1% isolates of Enterobacter spp. showed intermediate susceptibility to fosfomycin. Resistance to fosfomycin was detected in only one (2.5% isolate of E. coli. Conclusion:Based on the results of our study, fosfomycin is highly active against a collection of several gram-positive and gram-negative bacteria, including multidrug resistant isolates, and is an alternative drug in the treatment option.J Microbiol Infect Dis 2014;4(2: 55-58

  17. Are traditional cognitive tests useful in predicting clinical success?

    Science.gov (United States)

    Gray, Sarah A; Deem, Lisa P; Straja, Sorin R

    2002-11-01

    The purpose of this research was to determine the predictive value of the Dental Admission Test (DAT) for clinical success using Ackerman's theory of ability determinants of skilled performance. The Ackerman theory is a valid, reliable schema in the applied psychology literature used to predict complex skill acquisition. Inconsistent stimulus-response skill acquisition depends primarily on determinants of cognitive ability. Consistent information-processing tasks have been described as "automatic," in which stimuli and responses are mapped in a manner that allows for complete certainty once the relationships have been learned. It is theorized that the skills necessary for success in the clinical component of dental schools involve a significant amount of automatic processing demands and, as such, student performance in the clinics should begin to converge as task practice is realized and tasks become more consistent. Subtest scores of the DAT of four classes were correlated with final grades in nine clinical courses. Results showed that the DAT subtest scores played virtually no role with regard to the final clinical grades. Based on this information, the DAT scores were determined to be of no predictive value in clinical achievement.

  18. Persistent grief in the aftermath of mass violence: the predictive roles of posttraumatic stress symptoms, self-efficacy, and disrupted worldview.

    Science.gov (United States)

    Smith, Andrew J; Abeyta, Andrew A; Hughes, Michael; Jones, Russell T

    2015-03-01

    This study tested a conceptual model merging anxiety buffer disruption and social-cognitive theories to predict persistent grief severity among students who lost a close friend, significant other, and/or professor/teacher in tragic university campus shootings. A regression-based path model tested posttraumatic stress (PTS) symptom severity 3 to 4 months postshooting (Time 1) as a predictor of grief severity 1 year postshootings (Time 2), both directly and indirectly through cognitive processes (self-efficacy and disrupted worldview). Results revealed a model that predicted 61% of the variance in Time 2 grief severity. Hypotheses were supported, demonstrating that Time 1 PTS severity indirectly, positively predicted Time 2 grief severity through undermining self-efficacy and more severely disrupting worldview. Findings and theoretical interpretation yield important insights for future research and clinical application. (PsycINFO Database Record (c) 2015 APA, all rights reserved).

  19. Clinical efficacy of a new barium sulfate for abdominal CT

    International Nuclear Information System (INIS)

    Yamada, Tatuya; Kohno, Mitio; Uematsu, Sadao; Nisitani, Hiromu; Tanaka, Takao.

    1988-01-01

    Computed Tomography of the abdomen requires that the intestines are filled with contrast medium so that the gut is not misinterpreted as a pathologic process. Besides, normal structures may be difficult to delimit in patients with scanty intra-abdominal fat. In Japan, up to date, only a single contrast medium has been available for this purpose, Gastrografin and thus identical with the intravasculaly used Urografin or Angiografin. A new Barium Sulfate suspention (Fusimi Seiyaku, Kagawa) for computed tomographic use has been dilute solution (4.77 %) and with suspending agents that prevent a rapid sedimentation of the Barium Sulfate. The aim of this investigation was to compare Gastrografin with a new barium regarding patients tolerance, side effects and diagnostic information. The investigation comprised 146 patients who were reffered for abdominal CT and was carried out by 5 facilities; National Cancer Center, Kobe University, Chiba University, Kyushu University and Juntendo University. Diagnostic information was judged with respect to the filling of the stomach and intestines, the presence of imaging artifacts and finally clinical estimation. Patients tolerance was investigated as regards taste and side effects. Good filling of the stomach and intestines was obtained in this investigation. However, imaging artifacts occured in only a few cases. The imaging artifacts appeared almost exclusively to arise in the boundary layer between the bowel gas and contrast medium, and were most common in the stomach. However, the contrasting effect of this medium did not in itself appear to cause any imaging artifacts. Fushimi's new barium seems to be preffered because of its lesser tendency to arise artifacts and better tendency to make good filling of the stomach and intestines. Moreover, this investigation did not have any side effects. (J.P.N.)

  20. Predictive value of work-related self-efficacy change on RTW for employees with common mental disorders.

    Science.gov (United States)

    Lagerveld, Suzanne E; Brenninkmeijer, Veerle; Blonk, Roland W B; Twisk, Jos; Schaufeli, Wilmar B

    2017-05-01

    To improve interventions that aim to promote return to work (RTW) of workers with common mental disorders (CMD), insight into modifiable predictors of RTW is needed. This study tested the predictive value of self-efficacy change for RTW in addition to preintervention levels of self-efficacy. RTW self-efficacy was measured 5 times within 9 months among 168 clients of a mental healthcare organisation who were on sick leave due to CMD. Self-efficacy parameters were modelled with multilevel analyses and added as predictors into a Cox regression analysis. Results showed that both high baseline self-efficacy and self-efficacy increase until full RTW were predictive of a shorter duration until full RTW. Both self-efficacy parameters remained significant predictors of RTW when controlled for several relevant covariates and within subgroups of employees with either high or low preintervention self-efficacy levels. This is the first study that demonstrated the prognostic value of self-efficacy change, over and above the influence of psychological symptoms, for RTW among employees with CMD. By showing that RTW self-efficacy increase predicted a shorter duration until full RTW, this study points to the relevance of enhancing RTW self-efficacy in occupational or mental health interventions for employees with CMD. Efforts to improve self-efficacy appear valuable both for people with relatively low and high baseline self-efficacy. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  1. Genotype-based ancestral background consistently predicts efficacy and side effects across treatments in CATIE and STAR*D.

    Directory of Open Access Journals (Sweden)

    Daniel E Adkins

    Full Text Available Only a subset of patients will typically respond to any given prescribed drug. The time it takes clinicians to declare a treatment ineffective leaves the patient in an impaired state and at unnecessary risk for adverse drug effects. Thus, diagnostic tests robustly predicting the most effective and safe medication for each patient prior to starting pharmacotherapy would have tremendous clinical value. In this article, we evaluated the use of genetic markers to estimate ancestry as a predictive component of such diagnostic tests. We first estimated each patient's unique mosaic of ancestral backgrounds using genome-wide SNP data collected in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE (n = 765 and the Sequenced Treatment Alternatives to Relieve Depression (STAR*D (n = 1892. Next, we performed multiple regression analyses to estimate the predictive power of these ancestral dimensions. For 136/89 treatment-outcome combinations tested in CATIE/STAR*D, results indicated 1.67/1.84 times higher median test statistics than expected under the null hypothesis assuming no predictive power (p<0.01, both samples. Thus, ancestry showed robust and pervasive correlations with drug efficacy and side effects in both CATIE and STAR*D. Comparison of the marginal predictive power of MDS ancestral dimensions and self-reported race indicated significant improvements to model fit with the inclusion of MDS dimensions, but mixed evidence for self-reported race. Knowledge of each patient's unique mosaic of ancestral backgrounds provides a potent immediate starting point for developing algorithms identifying the most effective and safe medication for a wide variety of drug-treatment response combinations. As relatively few new psychiatric drugs are currently under development, such personalized medicine offers a promising approach toward optimizing pharmacotherapy for psychiatric conditions.

  2. Efficacy, Safety and Cost of Regorafenib in Patients with Metastatic Colorectal Cancer in French Clinical Practice.

    Science.gov (United States)

    Calcagno, Fabien; Lenoble, Sabrina; Lakkis, Zaher; Nguyen, Thierry; Limat, Samuel; Borg, Christophe; Jary, Marine; Kim, Stefano; Nerich, Virginie

    2016-01-01

    Regorafenib is an orally administered multikinase inhibitor that has been approved for patients with chemotherapy-refractory metastatic colorectal cancer (mCRC). Even though regorafenib significantly improved survival in two international phase 3 trials (CORRECT and CONCUR), a high rate of treatment-related toxic effects and dose modifications were observed with a modest benefit. The aim of this study was to provide information concerning the efficacy, safety, and cost of regorafenib in patients with mCRC in clinical practice. We retrospectively reviewed patients treated with regorafenib monotherapy for unresectable mCRC in five Franche-Comté cancer hospitals (France). The primary end point was overall survival. Secondary end points were safety and descriptive cost analyses of patients treated with regorafenib in clinical practice. Another aim of this study was to assess the impact of regorafenib prescription on the risk of hospitalization in real-life practice. From January 2014 to August 2014, 29 consecutive patients were enrolled. Patients were heavily pretreated and were refractory to standard chemotherapies. The primary tumor sites were the colon and the rectum for 55% and 45% of patients, respectively. Fifteen patients (51%) harbored an RAS mutation. Eastern Cooperative Oncology Group - Performance Status (PS) was 0-1 for 86% of patients and 2 for 14% of patients. Nineteen patients (66%) initially received reduced doses of 120 or 80 mg/day. The median duration of treatment was 2.5 months (range, 0.13-11.4 months). Treatment-related adverse events occurred in 86% of patients. The most frequent adverse events of any grade were fatigue (35%), diarrhea (20%), and hand-foot skin reaction (20%). Grade 3 or 4 treatment-related adverse events occurred in 10 patients (35%). Three patients (10%) were admitted to hospital due to drug-related severe adverse events. The mean cost of patient management with regorafenib for the duration of treatment was 9908 ± 8191

  3. Enhanced clinical pharmacy service targeting tools: risk-predictive algorithms.

    Science.gov (United States)

    El Hajji, Feras W D; Scullin, Claire; Scott, Michael G; McElnay, James C

    2015-04-01

    This study aimed to determine the value of using a mix of clinical pharmacy data and routine hospital admission spell data in the development of predictive algorithms. Exploration of risk factors in hospitalized patients, together with the targeting strategies devised, will enable the prioritization of clinical pharmacy services to optimize patient outcomes. Predictive algorithms were developed using a number of detailed steps using a 75% sample of integrated medicines management (IMM) patients, and validated using the remaining 25%. IMM patients receive targeted clinical pharmacy input throughout their hospital stay. The algorithms were applied to the validation sample, and predicted risk probability was generated for each patient from the coefficients. Risk threshold for the algorithms were determined by identifying the cut-off points of risk scores at which the algorithm would have the highest discriminative performance. Clinical pharmacy staffing levels were obtained from the pharmacy department staffing database. Numbers of previous emergency admissions and admission medicines together with age-adjusted co-morbidity and diuretic receipt formed a 12-month post-discharge and/or readmission risk algorithm. Age-adjusted co-morbidity proved to be the best index to predict mortality. Increased numbers of clinical pharmacy staff at ward level was correlated with a reduction in risk-adjusted mortality index (RAMI). Algorithms created were valid in predicting risk of in-hospital and post-discharge mortality and risk of hospital readmission 3, 6 and 12 months post-discharge. The provision of ward-based clinical pharmacy services is a key component to reducing RAMI and enabling the full benefits of pharmacy input to patient care to be realized. © 2014 John Wiley & Sons, Ltd.

  4. Neonatal Pulmonary MRI of Bronchopulmonary Dysplasia Predicts Short-term Clinical Outcomes.

    Science.gov (United States)

    Higano, Nara S; Spielberg, David R; Fleck, Robert J; Schapiro, Andrew H; Walkup, Laura L; Hahn, Andrew D; Tkach, Jean A; Kingma, Paul S; Merhar, Stephanie L; Fain, Sean B; Woods, Jason C

    2018-05-23

    Bronchopulmonary dysplasia (BPD) is a serious neonatal pulmonary condition associated with premature birth, but the underlying parenchymal disease and trajectory are poorly characterized. The current NICHD/NHLBI definition of BPD severity is based on degree of prematurity and extent of oxygen requirement. However, no clear link exists between initial diagnosis and clinical outcomes. We hypothesized that magnetic resonance imaging (MRI) of structural parenchymal abnormalities will correlate with NICHD-defined BPD disease severity and predict short-term respiratory outcomes. Forty-two neonates (20 severe BPD, 6 moderate, 7 mild, 9 non-BPD controls; 40±3 weeks post-menstrual age) underwent quiet-breathing structural pulmonary MRI (ultrashort echo-time and gradient echo) in a NICU-sited, neonatal-sized 1.5T scanner, without sedation or respiratory support unless already clinically prescribed. Disease severity was scored independently by two radiologists. Mean scores were compared to clinical severity and short-term respiratory outcomes. Outcomes were predicted using univariate and multivariable models including clinical data and scores. MRI scores significantly correlated with severities and predicted respiratory support at NICU discharge (P<0.0001). In multivariable models, MRI scores were by far the strongest predictor of respiratory support duration over clinical data, including birth weight and gestational age. Notably, NICHD severity level was not predictive of discharge support. Quiet-breathing neonatal pulmonary MRI can independently assess structural abnormalities of BPD, describe disease severity, and predict short-term outcomes more accurately than any individual standard clinical measure. Importantly, this non-ionizing technique can be implemented to phenotype disease and has potential to serially assess efficacy of individualized therapies.

  5. Predictive value of work-related self-efficacy change on RTW for employees with common mental disorders

    NARCIS (Netherlands)

    Lagerveld, S.E.; Brenninkmeijer, V.; Blonk, R.W.B.; Twisk, J.; Schaufeli, W.

    2017-01-01

    To improve interventions that aim to promote return to work (RTW) of workers with common mental disorders (CMD), insight into modifiable predictors of RTW is needed. This study tested the predictive value of self-efficacy change for RTW in addition to preintervention levels of self-efficacy. RTW

  6. Predictive value of work-related self-efficacy change on RTW for employees with common mental disorders

    NARCIS (Netherlands)

    Lagerveld, S.E.; Brenninkmeijer, V.; Blonk, R.W.B.; Twisk, J.W.R.; Schaufeli, W.B.

    To improve interventions that aim to promote return to work (RTW) of workers with common mental disorders (CMD), insight into modifiable predictors of RTW is needed. This study tested the predictive value of self-efficacy change for RTW in addition to preintervention levels of self-efficacy. RTW

  7. Imbalanced target prediction with pattern discovery on clinical data repositories.

    Science.gov (United States)

    Chan, Tak-Ming; Li, Yuxi; Chiau, Choo-Chiap; Zhu, Jane; Jiang, Jie; Huo, Yong

    2017-04-20

    Clinical data repositories (CDR) have great potential to improve outcome prediction and risk modeling. However, most clinical studies require careful study design, dedicated data collection efforts, and sophisticated modeling techniques before a hypothesis can be tested. We aim to bridge this gap, so that clinical domain users can perform first-hand prediction on existing repository data without complicated handling, and obtain insightful patterns of imbalanced targets for a formal study before it is conducted. We specifically target for interpretability for domain users where the model can be conveniently explained and applied in clinical practice. We propose an interpretable pattern model which is noise (missing) tolerant for practice data. To address the challenge of imbalanced targets of interest in clinical research, e.g., deaths less than a few percent, the geometric mean of sensitivity and specificity (G-mean) optimization criterion is employed, with which a simple but effective heuristic algorithm is developed. We compared pattern discovery to clinically interpretable methods on two retrospective clinical datasets. They contain 14.9% deaths in 1 year in the thoracic dataset and 9.1% deaths in the cardiac dataset, respectively. In spite of the imbalance challenge shown on other methods, pattern discovery consistently shows competitive cross-validated prediction performance. Compared to logistic regression, Naïve Bayes, and decision tree, pattern discovery achieves statistically significant (p-values repositories with imbalance and noise. The prediction results and interpretable patterns can provide insights in an agile and inexpensive way for the potential formal studies.

  8. Biomarkers for Monitoring Clinical Efficacy of Allergen Immunotherapy for Allergic Rhinoconjunctivitis and Allergic Asthma

    DEFF Research Database (Denmark)

    Shamji, M H; Kappen, J H; Akdis, M

    2017-01-01

    be administered either subcutaneously (SCIT) or sublingually (SLIT) (3-12). Although AIT is effective, the degree of remission strongly varies depending on the complex interaction between patient, allergy, symptomatology and vaccines used for AIT (3-9). Clinical management of patients receiving AIT and efficacy...... medicine (18). This article is protected by copyright. All rights reserved....

  9. The efficacy of chiropractic manipulation for back pain : Blinded review of relevant randomized clinical trials

    NARCIS (Netherlands)

    Assendelft, W. J J; Koes, B. W.; Van der Heijden, G. J M G; Bouter, L. M.

    1992-01-01

    Objective: To assess the efficacy of chiropractic for patients with back pain. Data Sources: Randomized clinical trials (RCTs) on spinal manipulation were identified with a Medline search (1966-1990), by citation tracking, and by manual examination of the relevant chiropractic reference systems

  10. Bullying Behaviors and Self Efficacy among Nursing Students at Clinical Settings: Comparative Study

    Science.gov (United States)

    Kassem, Awatef Hassan

    2015-01-01

    Background: Nursing students who experienced bullying behaviors feel anger and missing their concentration, their capability to achieve a desired outcome. Also self-efficacy, often referred to as self-confidence, is essential to nursing students' ability and performance in the clinical setting. Aim: Study aimed to examine relation between bullying…

  11. Promoting Assessment Efficacy through an Integrated System for Online Clinical Assessment of Practical Skills

    Science.gov (United States)

    Hay, Peter J.; Engstrom, Craig; Green, Anita; Friis, Peter; Dickens, Sue; Macdonald, Doune

    2013-01-01

    This paper presents evaluation outcomes from an externally funded research project involving the online clinical assessment of practical skills (eCAPS) using web-based video technologies within a university medical programme. eCAPS was implemented to trial this web-based approach for promoting the efficacy of "practical" skills…

  12. Moving from Efficacy to Effectiveness in Cognitive Behavioral Therapy for Psychosis: A Randomized Clinical Practice Trial

    Science.gov (United States)

    Lincoln, Tania M.; Ziegler, Michael; Mehl, Stephanie; Kesting, Marie-Luise; Lullmann, Eva; Westermann, Stefan; Rief, Winfried

    2012-01-01

    Objective: Randomized controlled trials have attested the efficacy of cognitive behavioral therapy (CBT) in reducing psychotic symptoms. Now, studies are needed to investigate its effectiveness in routine clinical practice settings. Method: Eighty patients with schizophrenia spectrum disorders who were seeking outpatient treatment were randomized…

  13. Connecting clinical and actuarial prediction with rule-based methods.

    Science.gov (United States)

    Fokkema, Marjolein; Smits, Niels; Kelderman, Henk; Penninx, Brenda W J H

    2015-06-01

    Meta-analyses comparing the accuracy of clinical versus actuarial prediction have shown actuarial methods to outperform clinical methods, on average. However, actuarial methods are still not widely used in clinical practice, and there has been a call for the development of actuarial prediction methods for clinical practice. We argue that rule-based methods may be more useful than the linear main effect models usually employed in prediction studies, from a data and decision analytic as well as a practical perspective. In addition, decision rules derived with rule-based methods can be represented as fast and frugal trees, which, unlike main effects models, can be used in a sequential fashion, reducing the number of cues that have to be evaluated before making a prediction. We illustrate the usability of rule-based methods by applying RuleFit, an algorithm for deriving decision rules for classification and regression problems, to a dataset on prediction of the course of depressive and anxiety disorders from Penninx et al. (2011). The RuleFit algorithm provided a model consisting of 2 simple decision rules, requiring evaluation of only 2 to 4 cues. Predictive accuracy of the 2-rule model was very similar to that of a logistic regression model incorporating 20 predictor variables, originally applied to the dataset. In addition, the 2-rule model required, on average, evaluation of only 3 cues. Therefore, the RuleFit algorithm appears to be a promising method for creating decision tools that are less time consuming and easier to apply in psychological practice, and with accuracy comparable to traditional actuarial methods. (c) 2015 APA, all rights reserved).

  14. New in vitro system to predict chemotherapeutic efficacy of drug combinations in fresh tumor samples

    Directory of Open Access Journals (Sweden)

    Frank Christian Kischkel

    2017-03-01

    Full Text Available Background To find the best individual chemotherapy for cancer patients, the efficacy of different chemotherapeutic drugs can be predicted by pretesting tumor samples in vitro via the chemotherapy-resistance (CTR-Test®. Although drug combinations are widely used among cancer therapy, so far only single drugs are tested by this and other tests. However, several first line chemotherapies are combining two or more chemotherapeutics, leading to the necessity of drug combination testing methods. Methods We established a system to measure and predict the efficacy of chemotherapeutic drug combinations with the help of the Loewe additivity concept in combination with the CTR-test. A combination is measured by using half of the monotherapy’s concentration of both drugs simultaneously. With this method, the efficacy of a combination can also be calculated based on single drug measurements. Results The established system was tested on a data set of ovarian carcinoma samples using the combination carboplatin and paclitaxel and confirmed by using other tumor species and chemotherapeutics. Comparing the measured and the calculated values of the combination testings revealed a high correlation. Additionally, in 70% of the cases the measured and the calculated values lead to the same chemotherapeutic resistance category of the tumor. Conclusion Our data suggest that the best drug combination consists of the most efficient single drugs and the worst drug combination of the least efficient single drugs. Our results showed that single measurements are sufficient to predict combinations in specific cases but there are exceptions in which it is necessary to measure combinations, which is possible with the presented system.

  15. Three-phase Bone Scintigraphy Can Predict the Analgesic Efficacy of Ketamine Therapy in CRPS.

    Science.gov (United States)

    Sorel, Marc; Beatrix, Jacques-Christian; Locko, Blanche; Armessen, Catherine; Domec, Anne-Marie; Lecompte, Otilia; Boucheneb, Sofiane; Harache, Benoit; Robert, Jacques; Lefaucheur, Jean-Pascal

    2018-03-13

    The efficacy of ketamine in relieving complex regional pain syndrome (CRPS) lacks predictive factors. The value of three-phase bone scintigraphy (TPBS) was assessed or this purpose. TPBS was performed in 105 patients with unilateral, focal CRPS of type 1 before 5 days of ketamine infusions. Tracer uptake was measured in the region of interest concerned by CRPS and the contralateral homologous region. For the three scintigraphic phases (vascular, tissular, and bone phases), an asymmetry ratio of fixation was calculated between the affected and the unaffected sides (VPr, TPr, and BPr). Ketamine efficacy was assessed on pain intensity scores. Ketamine-induced pain relief did not correlate with VPr, TPr, and BPr, but with the ratios of these ratios: BPr/TPr (r=0.32, P=0.009), BPr/VPr (r=0.34, P=0.005), and TPr/VPr (r=0.23, P=0.02). The optimum cut-off value for predicting the response to ketamine therapy was >1.125 for BPr/TPr, >1.075 for BPr/VPr, and >0.935 for TPr/VPr. The combination of increased values of BPr/TPr, BPr/VPr, and TPr/VPr was extremely significantly associated with ketamine therapy outcome. The relative hyperfixation of the radioactive tracer in the limb region concerned by CRPS in phases 2 and 3 versus phase 1 of TPBS correlated positively to the analgesic efficacy of ketamine. This study shows for the first time the potential predictive value of TPBS regarding ketamine therapy outcome. In addition, these results suggest that the analgesic action of ketamine is not restricted to "central" mechanisms, but may also involve "peripheral" mechanisms related to tissue inflammation and bone remodeling.

  16. Some uses of predictive probability of success in clinical drug development

    Directory of Open Access Journals (Sweden)

    Mauro Gasparini

    2013-03-01

    Full Text Available Predictive probability of success is a (subjective Bayesian evaluation of the prob- ability of a future successful event in a given state of information. In the context of pharmaceutical clinical drug development, successful events relate to the accrual of positive evidence on the therapy which is being developed, like demonstration of su- perior efficacy or ascertainment of safety. Positive evidence will usually be obtained via standard frequentist tools, according to the regulations imposed in the world of pharmaceutical development.Within a single trial, predictive probability of success can be identified with expected power, i.e. the evaluation of the success probability of the trial. Success means, for example, obtaining a significant result of a standard superiority test.Across trials, predictive probability of success can be the probability of a successful completion of an entire part of clinical development, for example a successful phase III development in the presence of phase II data.Calculations of predictive probability of success in the presence of normal data with known variance will be illustrated, both for within-trial and across-trial predictions.

  17. Efficacy of cryotherapy for the treatment of cutaneous leishmaniasis: meta-analyses of clinical trials.

    Science.gov (United States)

    López-Carvajal, Liliana; Cardona-Arias, Jaiberth Antonio; Zapata-Cardona, María Isabel; Sánchez-Giraldo, Vanesa; Vélez, Iván Darío

    2016-07-26

    Cryotherapy is a local treatment for cutaneous leishmaniasis with variable efficacy and greater safety than conventional treatment. The objective of this study is to evaluate the efficacy and safety of cryotherapy for the treatment of cutaneous leishmaniasis and to compare it with pentavalent antimonials. A meta-analysis based on a search of nine databases with eight strategies was conducted. Inclusion and exclusion criteria were applied, the methodological quality of each article was evaluated, and the reproducibility of the study selection and information extraction from each clinical trial was assured. The per lesion and per patient efficacy was calculated, and a meta-analysis of relative risks with the random effects model and the Dersimonian and Laird's, Begg, and Egger tests, along with a sensitivity analysis, were performed. A meta-regression based on the methodological quality of the trials included was also performed. Eight studies were included in which respective per lesion efficacies of 67.3 % and 67.7 % were reported for cryotherapy and pentavalent antimonials. In 271 patients treated with cryotherapy and in 199 with pentavalent antimonials, respective per protocol and intent to treat efficacies of 63.6 % and 54.2 % were found in the first group, and per protocol and intent to treat efficacies of 74.7 % and 68.3 % were found in the second group. The relative risk for the comparison of efficacy in the two groups was 0.73 (0.42-1.29). The results of the sensitivity analysis and the meta-regression analysis of relative risks were statistically equal to the overall results. This investigation provides evidence in favor of the use of cryotherapy given that its efficacy is similar to that of pentavalent antimonials.

  18. Dietary self-efficacy predicts AHEI diet quality in women with previous gestational diabetes.

    Science.gov (United States)

    Ferranti, Erin Poe; Narayan, K M Venkat; Reilly, Carolyn M; Foster, Jennifer; McCullough, Marjorie; Ziegler, Thomas R; Guo, Ying; Dunbar, Sandra B

    2014-01-01

    The purpose of this study was to examine the association of intrapersonal influences of diet quality as defined by the Health Belief Model constructs in women with recent histories of gestational diabetes. A descriptive, correlational, cross-sectional design was used to analyze relationships between diet quality and intrapersonal variables, including perceptions of threat of type 2 diabetes mellitus development, benefits and barriers of healthy eating, and dietary self-efficacy, in a convenience sample of 75 community-dwelling women (55% minority; mean age, 35.5 years; SD, 5.5 years) with previous gestational diabetes mellitus. Diet quality was defined by the Alternative Healthy Eating Index (AHEI). Multiple regression was used to identify predictors of AHEI diet quality. Women had moderate AHEI diet quality (mean score, 47.6; SD, 14.3). Only higher levels of education and self-efficacy significantly predicted better AHEI diet quality, controlling for other contributing variables. There is a significant opportunity to improve diet quality in women with previous gestational diabetes mellitus. Improving self-efficacy may be an important component to include in nutrition interventions. In addition to identifying other important individual components, future studies of diet quality in women with previous gestational diabetes mellitus are needed to investigate the scope of influence beyond the individual to potential family, social, and environmental factors. © 2014 The Author(s).

  19. Clinical Efficacy of Proton Pump Inhibitor versus Prompt Endoscopy for Management of People with Dyspepsia

    DEFF Research Database (Denmark)

    Kjeldsen, Hans Christian; Lauritzen, Torsten; Christensen, Bo

      Title:   Clinical Efficacy of Proton Pump Inhibitor versus Prompt Endoscopy for Management of People with Dyspepsia: A Randomized Clinical Trial in General Practice.     Purpose: To compare the clinical efficacy of two strategies for management of dyspepsia in general practice in a RCT design.......   Setting: June 2000 to August 2002, 41 GPs, Aarhus County, Denmark   Methods: 368 people with dyspepsia (epigastric pain/discomfort, no alarm symptoms) were randomly assigned to treatment with omeprazol 40 mg/day for two weeks (PPI group, n:185) or endoscopy (endoscopy group, n:183). Due to migration......, dyspeptic contacts to GP or patients' satisfaction. Conclusions: Prompt endoscopy was superior to proton pump inhibitor concerning symptom improvement in management of dyspepsia in general practice when pain/discomfort was the primary symptom. There were no differences between the two strategies in respect...

  20. Should academic medical centers conduct clinical trials of the efficacy of intercessory prayer?

    Science.gov (United States)

    Halperin, E C

    2001-08-01

    Intercessory prayers for health or healing are requests to an object of worship for the preservation or restoration of health. There has been a recent proliferation of clinical trials that compare the health outcome of a group of prayed-for patients with that of controls, to test the efficacy of intercessory prayer. In this essay, the author defines the concept of intercessory prayer, contrasts it with other forms of prayer, and reviews the literature concerning clinical trials of its efficacy. The arguments put forward in favor of conducting such trials and those against are described and the reader is invited to consider their relative merits. The author concludes by discussing the potential power of faith in healing, reviewing the philosophical basis and pitfalls of clinical trials of intercessory prayer, and urging readers to weigh the arguments for and against such trials in academic medicine.

  1. The prediction of parental self-efficacy and hyper-anxiety symptoms based on the components of mindfulness in women with multiple sclerosis

    Directory of Open Access Journals (Sweden)

    Mohammad Mohammadi Pour

    2017-08-01

    Full Text Available Introduction: The present study aimed to predict parental self-efficacy and hyper-anxiety symptoms based on the components of mindfulness in women with multiple sclerosis (MS. Materials and Methods: The statistical population of this descriptive-correlational study included all women with MS in Mashhad during March-Jun 2016 who referred for treatment to clinics, neurologists and psychological centers. The statistical sample consisted of 105 women with MS who were selected using convenient sampling method. In order to collect data, Parental Self-Efficacy Questionnaire, Beck Anxiety Inventory (BIA and Mindfulness Questionnaire were used. Data were analyzed using multivariate regression method. Results: The results revealed that the components of mindfulness, judgment and non-reactivity can reduce anxiety significantly in women with MS. In addition, action with awareness, judgment and non-reactivity can increase parental self-efficacy (P

  2. Clinical gestalt and the prediction of massive transfusion after trauma.

    Science.gov (United States)

    Pommerening, Matthew J; Goodman, Michael D; Holcomb, John B; Wade, Charles E; Fox, Erin E; Del Junco, Deborah J; Brasel, Karen J; Bulger, Eileen M; Cohen, Mitch J; Alarcon, Louis H; Schreiber, Martin A; Myers, John G; Phelan, Herb A; Muskat, Peter; Rahbar, Mohammad; Cotton, Bryan A

    2015-05-01

    Early recognition and treatment of trauma patients requiring massive transfusion (MT) has been shown to reduce mortality. While many risk factors predicting MT have been demonstrated, there is no universally accepted method or algorithm to identify these patients. We hypothesised that even among experienced trauma surgeons, the clinical gestalt of identifying patients who will require MT is unreliable. Transfusion and mortality outcomes after trauma were observed at 10 U.S. Level-1 trauma centres in patients who survived ≥ 30 min after admission and received ≥ 1 unit of RBC within 6h of arrival. Subjects who received ≥ 10 units within 24h of admission were classified as MT patients. Trauma surgeons were asked the clinical gestalt question "Is the patient likely to be massively transfused?" 10 min after the patients arrival. The performance of clinical gestalt to predict MT was assessed using chi-square tests and ROC analysis to compare gestalt to previously described scoring systems. Of the 1245 patients enrolled, 966 met inclusion criteria and 221 (23%) patients received MT. 415 (43%) were predicted to have a MT and 551(57%) were predicted to not have MT. Patients predicted to have MT were younger, more often sustained penetrating trauma, had higher ISS scores, higher heart rates, and lower systolic blood pressures (all pGestalt sensitivity was 65.6% and specificity was 63.8%. PPV and NPV were 34.9% and 86.2% respectively. Data from this large multicenter trial demonstrates that predicting the need for MT continues to be a challenge. Because of the increased mortality associated with delayed therapy, a more reliable algorithm is needed to identify and treat these severely injured patients earlier. Copyright © 2015 Elsevier Ltd. All rights reserved.

  3. Clinical Efficacy of Various Diagnostic Tests for Small Bowel Tumors and Clinical Features of Tumors Missed by Capsule Endoscopy

    Directory of Open Access Journals (Sweden)

    Jung Wan Han

    2015-01-01

    Full Text Available Background. We aimed to evaluate the efficacy of various diagnostic tools such as computerized tomography (CT, small bowel follow-through (SBFT, and capsule endoscopy (CE in diagnosing small bowel tumors (SBTs. Additionally, we aimed to evaluate the clinical features of SBTs missed by CE. Methods. We retrospectively studied 79 patients with histologically proven SBT. Clinical data were analyzed with particular attention to the efficacy of CT, SBFT, and CE in detecting SBT preoperatively. We also analyzed the clinical features of SBTs missed by CE. Results. The most common symptoms of SBT were bleeding (43% and abdominal pain (13.9%. Diagnostic yields were as follows: CT detected 55.8% of proven SBTs; SBFT, 46.1%; and CE, 83.3%. The sensitivity for detecting SBTs was 40.4% for CT, 43.9% for SBFT, and 79.6% for CE. Two patients with nondiagnostic but suspicious findings on CE and seven patients with negative findings on CE were eventually found to have SBT. These nine patients were eventually diagnosed with gastrointestinal stromal tumor (4, small polyps (3, inflammatory fibroid polyp (1, and adenocarcinoma (1. These tumors were located in the proximal jejunum (5, middle jejunum (1, distal jejunum (1, and proximal ileum (1. Conclusion. CE is more efficacious than CT or SBFT for detecting SBTs. However, significant tumors may go undetected with CE, particularly when located in the proximal jejunum.

  4. A predictive approach to selecting the size of a clinical trial, based on subjective clinical opinion.

    Science.gov (United States)

    Spiegelhalter, D J; Freedman, L S

    1986-01-01

    The 'textbook' approach to determining sample size in a clinical trial has some fundamental weaknesses which we discuss. We describe a new predictive method which takes account of prior clinical opinion about the treatment difference. The method adopts the point of clinical equivalence (determined by interviewing the clinical participants) as the null hypothesis. Decision rules at the end of the study are based on whether the interval estimate of the treatment difference (classical or Bayesian) includes the null hypothesis. The prior distribution is used to predict the probabilities of making the decisions to use one or other treatment or to reserve final judgement. It is recommended that sample size be chosen to control the predicted probability of the last of these decisions. An example is given from a multi-centre trial of superficial bladder cancer.

  5. Relative contributions of self-efficacy, self-regulation, and self-handicapping in predicting student procrastination.

    Science.gov (United States)

    Strunk, Kamden K; Steele, Misty R

    2011-12-01

    The relative contributions of self-efficacy, self-regulation, and self-handicapping student procrastination were explored. College undergraduate participants (N = 138; 40 men, 97 women, one not reporting sex) filled out the Procrastination Scale, the Self-Handicapping Scale-Short Form, and the Self-regulation and Self-handicapping scales of the Motivated Strategies for Learning Questionnaire. A hierarchical regression of the above measures indicated that self-efficacy, self-regulation, and self-handicapping all predicted scores on the Procrastination Scale, but self-regulation fully accounted for the predictive power of self-efficacy. The results suggested self-regulation and self-handicapping predict procrastination independently. These findings are discussed in relation to the literature on the concept of "self-efficacy for self-regulation" and its use in the field of procrastination research.

  6. Tumor Necrosis Factor Inhibitor Primary Failure Predicts Decreased Ustekinumab Efficacy in Psoriasis Patients.

    Science.gov (United States)

    Sorensen, Eric P; Fanucci, Kristina A; Saraiya, Ami; Volf, Eva; Au, Shiu-chung; Argobi, Yahya; Mansfield, Ryan; Gottlieb, Alice B

    2015-08-01

    Additional studies are needed to examine the efficacy of ustekinumab in psoriasis patients who have previously been exposed to tumor necrosis factor inhibitors (TNFi). To examine the predictive effect of TNFi primary failure and the number of TNFi exposures on the efficacy of ustekinumab in psoriasis treatment. This retrospective study examined 44 psoriasis patients treated at the Tufts Medical Center Department of Dermatology between January 2008 and July 2014. Patients were selected if they were treated with ustekinumab and had ≥ 1 previous TNFi exposure. The following subgroups were compared: patients with vs without a previous TNFi primary failure, and patients with one vs multiple previous TNFi exposures. The efficacy measure used was the previously validated Simple Measure for Assessing Psoriasis Activity (S-MAPA), which is calculated by the product of the body surface area and physician global assessment. The primary outcome was the percentage improvement S-MAPA from course baseline at week 12 of ustekinumab treatment. Secondary outcomes were the psoriasis clearance, primary failure, and secondary failure rates with ustekinumab treatment. Patients with a previous TNFi primary failure had a significantly lower percentage improvement in S-MAPA score at week 12 of ustekinumab treatment compared with patients without TNFi primary failure (36.2% vs 61.1%, P=.027). Multivariate analysis demonstrated that this relationship was independent of patient demographics and medical comorbidities. Patients with multiple TNFi exposures had a non-statistically significant lower percentage S-MAPA improvement at week 12 (40.5% vs 52.9%, P=.294) of ustekinumab treatment compared with patients with a single TNFi exposure. Among psoriasis patients previously exposed to TNFi, a history of a previous TNFi primary failure predicts a decreased response to ustekinumab independent of patient demographics and medical comorbidities.

  7. Visumax femtolasik versus Moria M2 microkeratome in mild to moderate myopia: efficacy, safety, predictability, aberrometric changes and flap thickness predictability.

    Science.gov (United States)

    Torky, Magda A; Al Zafiri, Yousif A; Khattab, Abeer M; Farag, Rania K; Awad, Eman A

    2017-07-17

    This is an interventional prospective clinical study which was conducted to evaluate the efficacy, safety, predictability, ocular aberrations, and flap thickness predictability of Visumax femtosecond laser (FSL) compared to Moria M2 microkeratome (MK) in mild to moderate myopia. This study included 60 eyes who were divided into two groups. Thirty eyes in group (I) in which the flap was created with Visumax FSL, while in group II (30 eyes) the Moria M2 MK was used. Keratometric, refractive, and aberrometric measurements were compared preoperatively and 3 months postoperatively. The intraoperative subtraction pachymetry (the SP 100 Handy pachymeter (Tomey, Nagoya, Japan) was used for preoperative pachymetry and flap thickness measurement. No significant difference was found between the two groups in regards to postoperative manifest sphere, spherical equivalent, astigmatism, safety indices nor ocular aberrations. Twenty six eyes (86.6%) in group I and 23 eyes in group II (76.6%) were within ±0.5D of the intended correction and 23 eyes (76.6%) in group I and 15 eyes in group II (50%) were within ±0.25D of the intended correction. In group I, the mean postoperative actual flap thickness was 100.12 ± 16.1 μm (81 to 122 μm), while in group II, it was 104.6 ± 20.1 μm (62 to 155 μm). The difference was statistically significant (p = 0.001). Both Visumax and Moria M2 MK are safe and effective in treating myopia with no statistically significant difference in induction of ocular aberrations but with potential advantage for Visumax regarding predictability. More accurate flap thickness is achieved with Visumax femtolasik. This study was retrospectively registered on 19/6/2017. Trial registration number NCT03193411 , clinicalTrials.gov .

  8. A Clinical Indications Prediction Scale Based on TWIST1 for Human Mesenchymal Stem Cells

    Directory of Open Access Journals (Sweden)

    Siddaraju V. Boregowda

    2016-02-01

    Full Text Available In addition to their stem/progenitor properties, mesenchymal stem cells (MSCs also exhibit potent effector (angiogenic, antiinflammatory, immuno-modulatory functions that are largely paracrine in nature. It is widely believed that effector functions underlie most of the therapeutic potential of MSCs and are independent of their stem/progenitor properties. Here we demonstrate that stem/progenitor and effector functions are coordinately regulated at the cellular level by the transcription factor Twist1 and specified within populations according to a hierarchical model. We further show that manipulation of Twist1 levels by genetic approaches or by exposure to widely used culture supplements including fibroblast growth factor 2 (Ffg2 and interferon gamma (IFN-gamma alters MSC efficacy in cell-based and in vivo assays in a predictable manner. Thus, by mechanistically linking stem/progenitor and effector functions our studies provide a unifying framework in the form of an MSC hierarchy that models the functional complexity of populations. Using this framework, we developed a CLinical Indications Prediction (CLIP scale that predicts how donor-to-donor heterogeneity and culture conditions impact the therapeutic efficacy of MSC populations for different disease indications.

  9. Physiotherapy students' perceptions and experiences of clinical prediction rules.

    Science.gov (United States)

    Knox, Grahame M; Snodgrass, Suzanne J; Stanton, Tasha R; Kelly, David H; Vicenzino, Bill; Wand, Benedict M; Rivett, Darren A

    2017-09-01

    Clinical reasoning can be difficult to teach to pre-professional physiotherapy students due to their lack of clinical experience. It may be that tools such as clinical prediction rules (CPRs) could aid the process, but there has been little investigation into their use in physiotherapy clinical education. This study aimed to determine the perceptions and experiences of physiotherapy students regarding CPRs, and whether they are learning about CPRs on clinical placement. Cross-sectional survey using a paper-based questionnaire. Final year pre-professional physiotherapy students (n=371, response rate 77%) from five universities across five states of Australia. Sixty percent of respondents had not heard of CPRs, and a further 19% had not clinically used CPRs. Only 21% reported using CPRs, and of these nearly three-quarters were rarely, if ever, learning about CPRs in the clinical setting. However most of those who used CPRs (78%) believed CPRs assisted in the development of clinical reasoning skills and none (0%) was opposed to the teaching of CPRs to students. The CPRs most commonly recognised and used by students were those for determining the need for an X-ray following injuries to the ankle and foot (67%), and for identifying deep venous thrombosis (63%). The large majority of students in this sample knew little, if anything, about CPRs and few had learned about, experienced or practiced them on clinical placement. However, students who were aware of CPRs found them helpful for their clinical reasoning and were in favour of learning more about them. Copyright © 2016 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

  10. Clinical and functional criteria for predicting asthma in infants

    OpenAIRE

    Yu. L. Mizemitskiy; V. A. Pavlenko; I. M. Melnikova

    2015-01-01

    Objective: to determine clinical and functional criteria for predicting asthma in children who have sustained acute obstructive bronchitis in infancy. Subjects and methods. A total of 125 infants aged 2 to 36 months who had experienced 1 -2 episodes of acute obstructive bronchitis and treated at hospital were examined when bronchial obstruction syndrome was being relieved. In addition to physical examination, functional studies (computerized bronchophonography and heart rate variability asses...

  11. Genetic Counseling Supervisors' Self-Efficacy for Select Clinical Supervision Competencies.

    Science.gov (United States)

    Finley, Sabra Ledare; Veach, Pat McCarthy; MacFarlane, Ian M; LeRoy, Bonnie S; Callanan, Nancy

    2016-04-01

    Supervision is a primary instructional vehicle for genetic counseling student clinical training. Approximately two-thirds of genetic counselors report teaching and education roles, which include supervisory roles. Recently, Eubanks Higgins and colleagues published the first comprehensive list of empirically-derived genetic counseling supervisor competencies. Studies have yet to evaluate whether supervisors possess these competencies and whether their competencies differ as a function of experience. This study investigated three research questions: (1) What are genetic counselor supervisors' perceptions of their capabilities (self-efficacy) for a select group of supervisor competencies?, (2) Are there differences in self-efficacy as a function of their supervision experience or their genetic counseling experience, and 3) What training methods do they use and prefer to develop supervision skills? One-hundred thirty-one genetic counselor supervisors completed an anonymous online survey assessing demographics, self-efficacy (self-perceived capability) for 12 goal setting and 16 feedback competencies (Scale: 0-100), competencies that are personally challenging, and supervision training experiences and preferences (open-ended). A MANOVA revealed significant positive effects of supervision experience but not genetic counseling experience on participants' self-efficacy. Although mean self-efficacy ratings were high (>83.7), participant comments revealed several challenging competencies (e.g., incorporating student's report of feedback from previous supervisors into goal setting, and providing feedback about student behavior rather than personal traits). Commonly preferred supervision training methods included consultation with colleagues, peer discussion, and workshops/seminars.

  12. Clinical and functional criteria for predicting asthma in infants

    Directory of Open Access Journals (Sweden)

    Yu. L. Mizemitskiy

    2015-01-01

    Full Text Available Objective: to determine clinical and functional criteria for predicting asthma in children who have sustained acute obstructive bronchitis in infancy. Subjects and methods. A total of 125 infants aged 2 to 36 months who had experienced 1 -2 episodes of acute obstructive bronchitis and treated at hospital were examined when bronchial obstruction syndrome was being relieved. In addition to physical examination, functional studies (computerized bronchophonography and heart rate variability assessment were used. Immunological examination included determination of the serum levels of immunoglobulin E and interleuMn-17A. The infants who had sustained acute obstructive bronchitis were followed up for 12-36 months. Results. The infants who had sustained acute obstructive bronchitis in the presence of mild perinatal CNS damage caused by hypoxia were typified by high respiratory morbidity; early-onset bronchial obstruction; long-term bronchial obstruction relief; high incidence of grade 2 respiratory failure in acute obstructive bronchitis. These patients developed asthma more often than twice and repeated episodes of bronchial obstruction. ROC analysis was used to elaborate clinical and functional criteria for predicting the development of asthma in infants. Conclusion. The proposed additional clinical and functional criteria characterizing external respiratory dysfunction and autonomic homeostatic changes contribute to the early diagnosis of asthma and substantially increase the validity of prediction of its development in children younger than 3 years, which is of great importance for goal-oriented preventive measures.

  13. [Efficacy and Safety Evaluation of Bushen Shuji Granule in Treating Ankylosing Spondylitis Patients: a Clinical Study].

    Science.gov (United States)

    Kong, Wei-ping; Tao, Qing-wen; Zhang, Ying-ze; Yang, Shu; Xu, Yuan; Zhu, Xiao-xia; Jin, Yue; Yang, Wen-xue; Yan, Xiao-ping

    2015-06-01

    To evaluate the short-term efficacy and safety of Bushen Shuji Granule (BSG) in treating ankylosing spondylitis (AS) patients. A prospective randomized controlled clinical trial was carried out in 62 active stage AS patients with Shen deficiency Du-channel cold syndrome (SDDCS), who were randomly assigned to the BSG group (treated with BSG) and the control group (treated with Celecoxib Capsule). Twelve weeks consisted of one therapeutic course. Therapeutic effects were evaluated by ASAS20 and ASAS40 (set by Assessments in Ankylosing Spondylitis working group) , BASDA150, Chinese medical (CM) syndrome efficacy evaluation standards. BASDAI, the Bath Ankylosing Spondylitis Functional Index (BASFI), the Bath AS Metrology Index (BASMI), scores for spine pain, scores for pain at night, patient global assessment (PGA) , erythrocyte sedimentation rate (ESR) , and C reactive protein (CRP) were observed before and after treatment. After three-month treatment by BSG, ASAS20 standard rate was 63. 33% (19/30 cases) in the BSG group and 66.67% (20/30 cases) in the control group with no significant difference between the two groups (χ2 = 0.073, P > 0.05). The efficacy for CM syndromes was 70.00% (21/30 cases) in the BSG group, higher than that in the control group [40.00% (12/30 cases), χ2 = 5.455, P channel strengthening, blood activating, and channels dredging method had good short-term clinical efficacy and safety in treating AS.

  14. Enhanced chemoprophylactic and clinical efficacy of albendazole formulated as solid dispersions in experimental cystic echinococcosis.

    Science.gov (United States)

    Pensel, Patricia E; Castro, Silvina; Allemandi, Daniel; Bruni, Sergio Sánchez; Palma, Santiago D; Elissondo, María Celina

    2014-06-16

    Cystic echinococcosis is a chronic, complex, and still neglected disease. Although albendazole has demonstrated efficacy, only about one-third of patients experience complete remission or cure and 30-50% of treated patients develop some evidence of a therapeutic response. Different strategies have been developed in order to improve the albendazole water solubility and dissolution rate. The aim of the current work was to investigate the chemoprophylactic and clinical efficacy of an albendazole:poloxamer 188 solid dispersion formulation on mice infected with Echinococcus granulosus metacestodes. Albendazole formulated as solid dispersion had greater chemoprophylactic and clinical efficacy than albendazole alone. The improved in therapeutic efficacy could be a consequence of the increase in the systemic availability of albendazole sulfoxide. The work reported here demonstrates that in vivo treatment with albendazole:poloxamer 188 impairs the development of the hydatid cysts. This new pharmacotechnically based strategy could be a suitable alternative for treating cystic echinococcosis in humans. Copyright © 2014 Elsevier B.V. All rights reserved.

  15. Clinical efficacy of gene-modified stem cells in adenosine deaminase-deficient immunodeficiency.

    Science.gov (United States)

    Shaw, Kit L; Garabedian, Elizabeth; Mishra, Suparna; Barman, Provaboti; Davila, Alejandra; Carbonaro, Denise; Shupien, Sally; Silvin, Christopher; Geiger, Sabine; Nowicki, Barbara; Smogorzewska, E Monika; Brown, Berkley; Wang, Xiaoyan; de Oliveira, Satiro; Choi, Yeong; Ikeda, Alan; Terrazas, Dayna; Fu, Pei-Yu; Yu, Allen; Fernandez, Beatriz Campo; Cooper, Aaron R; Engel, Barbara; Podsakoff, Greg; Balamurugan, Arumugam; Anderson, Stacie; Muul, Linda; Jagadeesh, G Jayashree; Kapoor, Neena; Tse, John; Moore, Theodore B; Purdy, Ken; Rishi, Radha; Mohan, Kathey; Skoda-Smith, Suzanne; Buchbinder, David; Abraham, Roshini S; Scharenberg, Andrew; Yang, Otto O; Cornetta, Kenneth; Gjertson, David; Hershfield, Michael; Sokolic, Rob; Candotti, Fabio; Kohn, Donald B

    2017-05-01

    Autologous hematopoietic stem cell transplantation (HSCT) of gene-modified cells is an alternative to enzyme replacement therapy (ERT) and allogeneic HSCT that has shown clinical benefit for adenosine deaminase-deficient (ADA-deficient) SCID when combined with reduced intensity conditioning (RIC) and ERT cessation. Clinical safety and therapeutic efficacy were evaluated in a phase II study. Ten subjects with confirmed ADA-deficient SCID and no available matched sibling or family donor were enrolled between 2009 and 2012 and received transplantation with autologous hematopoietic CD34+ cells that were modified with the human ADA cDNA (MND-ADA) γ-retroviral vector after conditioning with busulfan (90 mg/m2) and ERT cessation. Subjects were followed from 33 to 84 months at the time of data analysis. Safety of the procedure was assessed by recording the number of adverse events. Efficacy was assessed by measuring engraftment of gene-modified hematopoietic stem/progenitor cells, ADA gene expression, and immune reconstitution. With the exception of the oldest subject (15 years old at enrollment), all subjects remained off ERT with normalized peripheral blood mononuclear cell (PBMC) ADA activity, improved lymphocyte numbers, and normal proliferative responses to mitogens. Three of nine subjects were able to discontinue intravenous immunoglobulin replacement therapy. The MND-ADA vector was persistently detected in PBMCs (vector copy number [VCN] = 0.1-2.6) and granulocytes (VCN = 0.01-0.3) through the most recent visits at the time of this writing. No patient has developed a leukoproliferative disorder or other vector-related clinical complication since transplant. These results demonstrate clinical therapeutic efficacy from gene therapy for ADA-deficient SCID, with an excellent clinical safety profile. ClinicalTrials.gov NCT00794508. Food and Drug Administration Office of Orphan Product Development award, RO1 FD003005; NHLBI awards, PO1 HL73104 and Z01 HG000122; UCLA

  16. Efficacy of curcumin in the treatment for oral submucous fibrosis - A randomized clinical trial

    OpenAIRE

    Hazarey, Vinay K; Sakrikar, Aditee R; Ganvir, Sindhu M

    2015-01-01

    Introduction: Oral submucous fibrosis (OSF) is a chronic, insidious disease that is associated with significant functional morbidity and an increased risk for malignancy. Turmeric and its active ingredient "curcumin′′ are being studied upon as chemopreventive agents in various diseases. The present study aims to determine the efficacy of curcumin in the treatment of OSF. Materials and Methods: Thirty clinically diagnosed OSF patients were divided into two groups, 15 patients in each group fro...

  17. Clinical efficacy of melittin in the treatment of cats infected with the feline immunodeficiency virus.

    Science.gov (United States)

    Hartmann, Anja D; Wilhelm, Natalie; Erfle, Volker; Hartmann, Katrin

    2016-12-05

    The bee venom melittin shows an antiviral efficacy against the human immunodeficiency virus in cell culture. It was shown to be non-toxic for cats. Aim of this pilot study was to investigate the clinical efficacy and side-effects of melittin in cats naturally infected with feline immunodeficiency virus (FIV). The study was performed as a prospective, placebo-controlled double-blinded trial. Twenty cats were included, of which 10 cats each were treated with either melittin (500 µg/kg body weight) or phosphate-buffered saline (placebo) subcutaneously twice per week. During the treatment period of 6 weeks, the cats' general health status, determined by the Karnofsky's score, and the severity of clinical signs (conjunctivitis and stomatitis) using a clinical scoring system were evaluated. Haematology, biochemistry profiles, lymphocyte subpopulations, CD4/CD8 ratio, and pterines (biopterine, 7-xanthopterine) as surrogate parameters were also compared. The general health status and the clinical scores for conjunctivitis and stomatitis improved in cats treated with melittin. A statistically significant improvement however could only be detected for conjunctivitis in cats treated with melittin compared to cats treated with placebo which was likely due to different scores between both groups at the beginning. No influence on the lymphocyte subpopulations, CD4/CD8 ratio, and pterine concentrations was observed. No side effects occurred in this study. In the protocol used in the present study, no significant efficacy of melittin could be detected. However, efficacy of melittin, especially if applied in a higher dosage as in the present study or for a longer period, could be evaluated in further studies. Synergistic effects if used in combination with classic antiretroviral drugs could be an interesting future approach.

  18. Suppression of TIM-1 predicates clinical efficacy of sublingual immunotherapy for allergic rhinitis in children.

    Science.gov (United States)

    Lin, Zhibin; Zhou, Lifeng; Luo, Xi; Xia, Wentong; Chen, Dehua; Xu, Rui; Wang, Jie; Luo, Renzhong; Xu, Geng; Li, Huabin

    2013-08-01

    To evaluate the clinical efficacy of sublingual immunotherapy (SLIT) with house-dust mite (HDM) extract and to examine the change of biomarkers (TIM-1, IL-5 and IL-10) after 6-month SLIT in children with allergic rhinitis (AR). One hundred and sixteen HDM-sensitized children with persistent AR were enrolled to assess the clinical efficacy of SLIT by determining the individual nasal symptom score (INSS) and total nasal symptom scores (TNSS) after 6-month SLIT. Moreover, the mRNA expression of TIM-1, IL-5 and IL-10 in peripheral blood mononuclear cells (PBMCs) was examined in 16 well-controlled and 12 uncontrolled AR patients using quantitative reverse transcription polymerase chain reaction (qRT-PCR). After 6-month SLIT, both TNSS and INSS scores were significantly decreased compared with the baseline value (p < 0.01). The rates for well-controlled, partly controlled and uncontrolled children were 43.1%, 32.8% and 24.1%, respectively. Accordingly, the mRNA levels of TIM-1 and IL-5 decreased significantly and IL-10 mRNA level increased significantly compared with the baseline value in well-controlled children (p < 0.05). Our findings suggest SLIT with HDM extract is effective and safe for AR children and TIM-1 may be considered as an indicator for evaluating the clinical efficacy of SLIT. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  19. Comparing 2 Whiplash Grading Systems to Predict Clinical Outcomes.

    Science.gov (United States)

    Croft, Arthur C; Bagherian, Alireza; Mickelsen, Patrick K; Wagner, Stephen

    2016-06-01

    Two whiplash severity grading systems have been developed: Quebec Task Force on Whiplash-Associated Disorders (QTF-WAD) and the Croft grading system. The majority of clinical studies to date have used the modified grading system published by the QTF-WAD in 1995 and have demonstrated some ability to predict outcome. But most studies include only injuries of lower severity (grades 1 and 2), preventing a broader interpretation. The purpose of this study was assess the ability of these grading systems to predict clinical outcome within the context of a broader injury spectrum. This study evaluated both grading systems for their ability to predict the bivalent outcome, recovery, within a sample of 118 whiplash patients who were part of a previous case-control designed study. Of these, 36% (controls) had recovered, and 64% (cases) had not recovered. The discrete bivariate distribution between recovery status and whiplash grade was analyzed using the 2-tailed cross-tabulation statistics. Applying the criteria of the original 1993 Croft grading system, the subset comprised 1 grade 1 injury, 32 grade 2 injuries, 53 grade 3 injuries, and 32 grade 4 injuries. Applying the criteria of the modified (QTF-WAD) grading system, there were 1 grade 1 injury, 89 grade 2 injuries, and 28 grade 3 injuries. Both whiplash grading systems correlated negatively with recovery; that is, higher severity grades predicted a lower probability of recovery, and statistically significant correlations were observed in both, but the Croft grading system substantially outperformed the QTF-WAD system on this measure. The Croft grading system for whiplash injury severity showed a better predictive measure for recovery status from whiplash injuries as compared with the QTF-WAD grading system.

  20. Review on the efficacy, safety and clinical applications of polihexanide, a modern wound antiseptic.

    Science.gov (United States)

    Hübner, N-O; Kramer, A

    2010-01-01

    Infected wounds are still one of the great challenges in medicine. In the last decade, it has become increasingly clear that antimicrobial chemotherapy is limited by the spread of antimicrobial resistance. Fortunately, new, highly effective antiseptic substances with a broad antimicrobial spectrum are available, so local treatment is expected to get increasingly more important in wound therapy. This paper reviews the antiseptic agent polihexanide (polyhexamethylene biguanide, PHMB), one of the most promising substances available today, from a clinical point of view, focusing on efficacy, safety and clinical applications. Copyright © 2010 S. Karger AG, Basel.

  1. Loss of Efficacy to Spinal Cord Stimulator Therapy: Clinical Evidence and Possible Causes.

    Science.gov (United States)

    Aiudi, Christopher M; Dunn, Roger Y; Burns, Sara M; Roth, Sarah A; Opalacz, Arissa; Zhang, Yi; Chen, Lucy; Mao, Jianren; Ahmed, Shihab U

    2017-11-01

    Although spinal cord stimulation (SCS) therapy has been shown to be efficacious in various pain conditions, the ability for SCS therapy to maintain long-term efficacy has been questioned. The purpose of this study was to investigate whether a loss of efficacy (LOE) phenomenon exists with SCS therapy and to investigate if this phenomenon is more apparent in any specific patient population. A retrospective, observation chart review was conducted to evaluate the patient response to SCS therapy over time. Massachusetts General Hospital, Boston, Massachusetts. Patients who received a SCS at the Massachusetts General Hospital, between January 1, 2002 and December 31, 2012, were invited to participate. A total of 62 patients were included in this study. Various models were created to analyze pain score changes over time using 2-tailed statistical analysis. Additionally, one-way ANOVA and Pearson's chi-square tests were used to determine if certain patient characteristics were associated with LOE. Compared to the visual analog scale (VAS) score at one month after device implantation, pain scores increased 1.95 points after 2 years (95% CI: 1.06 to 2.84, P = patient characteristic that helped predict LOE. However, patients who have significant baseline response to therapy may be more likely to experience LOE. Spinal cord stimulation, chronic pain, retrospective study, low frequency electrical stimulation, efficacy, chronic pain therapy.

  2. Efficacy of thermotherapy to treat cutaneous leishmaniasis: a meta-analysis of controlled clinical trials.

    Directory of Open Access Journals (Sweden)

    Jaiberth Antonio Cardona-Arias

    Full Text Available The efficacy of thermotherapy for the treatment of cutaneous leishmaniasis presents diverse results with low statistical power.To evaluate the efficacy of thermotherapy to treat cutaneous leishmaniasis.A meta-analysis of controlled clinical trials in 12 databases based on the implementation of a research protocol with inclusion and exclusion criteria and an assessment of methodological quality. The reproducibility and completeness were guaranteed in the information search and extraction. Heterogeneity, sensitivity and publication bias were assessed by graphical methods (Galbraith, L'Abblé, funnel plot, Egger plot, and influence plot and analytical methods (DerSimonian-Laird, Begg and Egger. Random-effects forest plots were constructed, and a cumulative meta-analysis was performed.Eight studies were included with 622 patients who underwent thermotherapy, with an efficacy of 73.2% (95% confidence interval (CI = 69.6-76.7%, and with 667 patients who underwent systemic treatment, with an efficacy of 70.6% (95% CI=67.1-74.1%. Heterogeneity between studies, good sensitivity for the combined measure, and no publication bias were observed. The relative risk for comparison of the efficacy of treatment was 1.02 (95%CI=0.91, 1.15, showing that the effectiveness of thermotherapy is equal to that of pentavalent antimonial drugs.Due to its efficacy, greater safety and lower cost, thermotherapy should be the first treatment option for cutaneous leishmaniasis in areas where the prevalence of the mucocutaneous form is low and in patients with contraindications to systemic treatment, such as kidney, liver and heart diseases, as well as in pregnant women, infants, and patients with human immunodeficiency virus infection/acquired immune deficiency syndrome.

  3. Reliability of diagnosis and clinical efficacy of visceral osteopathy: a systematic review.

    Science.gov (United States)

    Guillaud, Albin; Darbois, Nelly; Monvoisin, Richard; Pinsault, Nicolas

    2018-02-17

    In 2010, the World Health Organization published benchmarks for training in osteopathy in which osteopathic visceral techniques are included. The purpose of this study was to identify and critically appraise the scientific literature concerning the reliability of diagnosis and the clinical efficacy of techniques used in visceral osteopathy. Databases MEDLINE, OSTMED.DR, the Cochrane Library, Osteopathic Research Web, Google Scholar, Journal of American Osteopathic Association (JAOA) website, International Journal of Osteopathic Medicine (IJOM) website, and the catalog of Académie d'ostéopathie de France website were searched through December 2017. Only inter-rater reliability studies including at least two raters or the intra-rater reliability studies including at least two assessments by the same rater were included. For efficacy studies, only randomized-controlled-trials (RCT) or crossover studies on unhealthy subjects (any condition, duration and outcome) were included. Risk of bias was determined using a modified version of the quality appraisal tool for studies of diagnostic reliability (QAREL) in reliability studies. For the efficacy studies, the Cochrane risk of bias tool was used to assess their methodological design. Two authors performed data extraction and analysis. Eight reliability studies and six efficacy studies were included. The analysis of reliability studies shows that the diagnostic techniques used in visceral osteopathy are unreliable. Regarding efficacy studies, the least biased study shows no significant difference for the main outcome. The main risks of bias found in the included studies were due to the absence of blinding of the examiners, an unsuitable statistical method or an absence of primary study outcome. The results of the systematic review lead us to conclude that well-conducted and sound evidence on the reliability and the efficacy of techniques in visceral osteopathy is absent. The review is registered PROSPERO 12th of December

  4. Predicting HIV-1 transmission and antibody neutralization efficacy in vivo from stoichiometric parameters.

    Directory of Open Access Journals (Sweden)

    Oliver F Brandenberg

    2017-05-01

    Full Text Available The potential of broadly neutralizing antibodies targeting the HIV-1 envelope trimer to prevent HIV-1 transmission has opened new avenues for therapies and vaccines. However, their implementation remains challenging and would profit from a deepened mechanistic understanding of HIV-antibody interactions and the mucosal transmission process. In this study we experimentally determined stoichiometric parameters of the HIV-1 trimer-antibody interaction, confirming that binding of one antibody is sufficient for trimer neutralization. This defines numerical requirements for HIV-1 virion neutralization and thereby enables mathematical modelling of in vitro and in vivo antibody neutralization efficacy. The model we developed accurately predicts antibody efficacy in animal passive immunization studies and provides estimates for protective mucosal antibody concentrations. Furthermore, we derive estimates of the probability for a single virion to start host infection and the risks of male-to-female HIV-1 transmission per sexual intercourse. Our work thereby delivers comprehensive quantitative insights into both the molecular principles governing HIV-antibody interactions and the initial steps of mucosal HIV-1 transmission. These insights, alongside the underlying, adaptable modelling framework presented here, will be valuable for supporting in silico pre-trial planning and post-hoc evaluation of HIV-1 vaccination or antibody treatment trials.

  5. Variables that Predict Serve Efficacy in Elite Men's Volleyball with Different Quality of Opposition Sets.

    Science.gov (United States)

    Valhondo, Álvaro; Fernández-Echeverría, Carmen; González-Silva, Jara; Claver, Fernando; Moreno, M Perla

    2018-03-01

    The objective of this study was to determine the variables that predicted serve efficacy in elite men's volleyball, in sets with different quality of opposition. 3292 serve actions were analysed, of which 2254 were carried out in high quality of opposition sets and 1038 actions were in low quality of opposition sets, corresponding to a total of 24 matches played during the Men's European Volleyball Championships held in 2011. The independent variables considered in this study were the serve zone, serve type, serving player, serve direction, reception zone, receiving player and reception type; the dependent variable was serve efficacy and the situational variable was quality of opposition sets. The variables that acted as predictors in both high and low quality of opposition sets were the serving player, reception zone and reception type. The serve type variable only acted as a predictor in high quality of opposition sets, while the serve zone variable only acted as a predictor in low quality of opposition sets. These results may provide important guidance in men's volleyball training processes.

  6. Clinical comparison and complete cure rates of Terbinafine efficacy in affected onychomycotic toenails.

    Science.gov (United States)

    Shemer, A; Sakka, N; Baran, R; Scher, R; Amichai, B; Norman, L; Farhi, R; Magun, R; Brazilai, A; Daniel, R

    2015-03-01

    Clinical studies regarding complete cure rate of onychomycosis using oral Terbinafine have a very broad range (14-90%) based solely on response to treatment on the big toenail. To evaluate the efficacy of Terbinafine in all affected onychomycotic toenails and, furthermore, to evaluate differences in mycological, clinical and complete cure rate between affected onychomycotic toenails. Inclusion criteria are as follows: distolateralsubungual onychomycotic involvement of the hallux and additional involvement of at least two more toenails of the same foot. Exclusion criteria are as follows: patients with nail traumata and hypersensitivity to Terbinafine. Patients were treated with oral Terbinafine 250 mg/day for 16 weeks. Mycological analysis was performed using direct microscopy and culture. Clinical improvement was assessed using digital photography. Statistically significant difference was found in clinical improvement between the great toenail and all other involved toenails. The rate of complete cure (100% clinical cure and mycological cure) of the big toenail was lower (23%) as compared to the second (65%), third (51%) and the fourth toenail (67%). This is a case series study that was based on a single-centre cohort. Our results support findings that efficacy of Terbinafine should be based on all involved onychomycotic toenails; the big toenail is not superior in response compared to other affected toenails. © 2014 European Academy of Dermatology and Venereology.

  7. Clinical Relevance of Prognostic and Predictive Molecular Markers in Gliomas.

    Science.gov (United States)

    Siegal, Tali

    2016-01-01

    Sorting and grading of glial tumors by the WHO classification provide clinicians with guidance as to the predicted course of the disease and choice of treatment. Nonetheless, histologically identical tumors may have very different outcome and response to treatment. Molecular markers that carry both diagnostic and prognostic information add useful tools to traditional classification by redefining tumor subtypes within each WHO category. Therefore, molecular markers have become an integral part of tumor assessment in modern neuro-oncology and biomarker status now guides clinical decisions in some subtypes of gliomas. The routine assessment of IDH status improves histological diagnostic accuracy by differentiating diffuse glioma from reactive gliosis. It carries a favorable prognostic implication for all glial tumors and it is predictive for chemotherapeutic response in anaplastic oligodendrogliomas with codeletion of 1p/19q chromosomes. Glial tumors that contain chromosomal codeletion of 1p/19q are defined as tumors of oligodendroglial lineage and have favorable prognosis. MGMT promoter methylation is a favorable prognostic marker in astrocytic high-grade gliomas and it is predictive for chemotherapeutic response in anaplastic gliomas with wild-type IDH1/2 and in glioblastoma of the elderly. The clinical implication of other molecular markers of gliomas like mutations of EGFR and ATRX genes and BRAF fusion or point mutation is highlighted. The potential of molecular biomarker-based classification to guide future therapeutic approach is discussed and accentuated.

  8. Readmission prediction via deep contextual embedding of clinical concepts.

    Science.gov (United States)

    Xiao, Cao; Ma, Tengfei; Dieng, Adji B; Blei, David M; Wang, Fei

    2018-01-01

    Hospital readmission costs a lot of money every year. Many hospital readmissions are avoidable, and excessive hospital readmissions could also be harmful to the patients. Accurate prediction of hospital readmission can effectively help reduce the readmission risk. However, the complex relationship between readmission and potential risk factors makes readmission prediction a difficult task. The main goal of this paper is to explore deep learning models to distill such complex relationships and make accurate predictions. We propose CONTENT, a deep model that predicts hospital readmissions via learning interpretable patient representations by capturing both local and global contexts from patient Electronic Health Records (EHR) through a hybrid Topic Recurrent Neural Network (TopicRNN) model. The experiment was conducted using the EHR of a real world Congestive Heart Failure (CHF) cohort of 5,393 patients. The proposed model outperforms state-of-the-art methods in readmission prediction (e.g. 0.6103 ± 0.0130 vs. second best 0.5998 ± 0.0124 in terms of ROC-AUC). The derived patient representations were further utilized for patient phenotyping. The learned phenotypes provide more precise understanding of readmission risks. Embedding both local and global context in patient representation not only improves prediction performance, but also brings interpretable insights of understanding readmission risks for heterogeneous chronic clinical conditions. This is the first of its kind model that integrates the power of both conventional deep neural network and the probabilistic generative models for highly interpretable deep patient representation learning. Experimental results and case studies demonstrate the improved performance and interpretability of the model.

  9. Clinical efficacy of composite versus ceramic inlays and onlays: a systematic review.

    Science.gov (United States)

    Fron Chabouis, Hélène; Smail Faugeron, Violaine; Attal, Jean-Pierre

    2013-12-01

    Large tooth substance losses are frequent in posterior teeth because of primary caries or aging restorations. Inlays and onlays are often the minimal invasive solution in such cases, but the efficacy of the composite and ceramic materials used is unknown. We performed a systematic review of randomized controlled trials comparing the efficacy of composite and ceramic inlays or onlays. MEDLINE, Embase and the Cochrane Central Register of Controlled Trials were searched without any restriction on date or language, as were references of eligible studies and ClinicalTrials.gov. Eligible studies were randomized trials comparing the clinical efficacy of composite to ceramic inlays or onlays in adults with any clinical outcome for at least 6 months. From 172 records identified, we examined reports of 2 randomized controlled trials involving 138 inlays (no onlays evaluated) in 80 patients and exhibiting a high-risk of bias. Outcomes were clinical scores and major failures. The 3-year overall failure risk ratio was 2 [0.38-10.55] in favor of ceramic inlays although not statistically significant. The reported clinical scores (United States Public Health Services and Californian Dental Association) showed considerable heterogeneity between trials and could not be combined. We have very limited evidence that ceramics perform better than composite material for inlays in the short term. However, this result may not be valid in the long term, and other trials are needed. Trials should follow Fédération dentaire internationale recommendations and enhance their methodology. Trials comparing composite and ceramic onlays are needed. Copyright © 2013 Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

  10. Closing the antidepressant efficacy gap between clinical trials and real patient populations.

    Science.gov (United States)

    Wade, Alan G

    2006-01-01

    Overall, patient outcomes in the primary care of depression are seldom as good as those achieved in clinical trials - the "efficacy gap". Many factors contribute to this, including poor patient compliance, poor family and social support and negative media reporting of antidepressants. Indeed, negative media reporting has had far more impact on physicians' prescribing of antidepressants than have regulatory agencies, partly as a result of changing public attitudes. Negative media reports linking SSRIs to increased child suicide rates have also resulted in a decline in the prescribing of SSRIs to this age group, but with no concomitant increase in the prescribing of fluoxetine, the only antidepressant recommended for the treatment of children. There are also inadequacies in the guidelines available to primary care givers that might contribute to the efficacy gap. Guidelines can be too specific for clinical practice - especially where depression coexists with anxiety disorders - and too passive, resulting in delayed or inadequate intervention. Evidence suggests that many physicians prefer to be more proactive. In the recent AHEAD survey, physicians identified faster resolution of symptoms as the property most desirable for improving antidepressant therapy. There is recent evidence that structured long-term therapy and easily-implemented measurement-based care procedures can improve remission rates and help bridge the efficacy gap. If these can be allied with greater public/media understanding of depression and its treatment, along with improved guidelines, then significant progress can be anticipated in the management of mood disorders.

  11. Pharmacokinetics, pharmacodynamics and clinical efficacy of omalizumab for the treatment of asthma.

    Science.gov (United States)

    Luu, Maxime; Bardou, Marc; Bonniaud, Philippe; Goirand, Françoise

    2016-12-01

    Omalizumab is a subcutaneously administrated monoclonal anti-IgE antibody indicated in adults, adolescents and children 6 years of age and older with moderate to severe allergic asthma uncontrolled by conventional pharmacological treatments and sensitization to at least one perennial allergen. Area covered: This drug evaluation summarizes published data on pharmacokinetic and pharmacodynamic properties of omalizumab, on clinical efficacy and safety, including real-world evidence, and provides a medico-economic evaluation of the drug. Expert opinion: Omalizumab represents an efficient therapeutic option for the management of patients with uncontrolled moderate/severe allergic asthma. It provides a significant reduction in the asthma exacerbation rate with a steroid-sparing effect, an improvement in quality of life in adults and adolescents, despite a lack of evidence about its efficacy specifically in severe allergic asthma. Clinical trials have demonstrated its efficacy in the pediatric population but further real-life evidence is expected to better characterize long-term effects in this population. There is still some debate about the optimal treatment duration but, to date, it is recommended not to stop the treatment as cessation has resulted in symptom recurrence. Omalizumab is an expensive treatment, but a key therapeutic option when used for uncontrolled severe allergic asthma.

  12. Clinical chemistry in higher dimensions: Machine-learning and enhanced prediction from routine clinical chemistry data.

    Science.gov (United States)

    Richardson, Alice; Signor, Ben M; Lidbury, Brett A; Badrick, Tony

    2016-11-01

    Big Data is having an impact on many areas of research, not the least of which is biomedical science. In this review paper, big data and machine learning are defined in terms accessible to the clinical chemistry community. Seven myths associated with machine learning and big data are then presented, with the aim of managing expectation of machine learning amongst clinical chemists. The myths are illustrated with four examples investigating the relationship between biomarkers in liver function tests, enhanced laboratory prediction of hepatitis virus infection, the relationship between bilirubin and white cell count, and the relationship between red cell distribution width and laboratory prediction of anaemia. Copyright © 2016 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  13. The first clinical experience on efficacy of topical flutamide on melasma compared with topical hydroquinone: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Adalatkhah H

    2015-08-01

    Full Text Available Hassan Adalatkhah,1 Homayoun Sadeghi-Bazargani2,3 1Department of Dermatology, Ardabil University of Medical Sciences, Ardabil, Iran; 2Road Traffic Injury Research Center, Department of Statistics and Epidemiology, Tabriz University of Medical Sciences, Tabriz, Iran; 3Department of Public Health Sciences, Karolinska Institute, Stockholm, Sweden Background: Treatment of melasma is unsatisfactory most of the times. Hormonal role is shown to exist in pathogenesis of the melasma, and sex-hormone related drugs may have an effect on melasma.Aim: To investigate efficacy of 1% flutamide cream versus 4% hydroquinone cream on melasma.Methods: In a parallel randomized clinical trial, 74 women with melasma were allocated to receive a sunscreen along with 4% hydroquinone cream or 1% flutamide cream. Melasma Area and Severity Index (MASI, mexameter melanin assay, and patient satisfaction were investigated.Results: Mean age of the participants was 33.8 years. Mean length of time suffering from Melasma was 96.3 months. The subjects reported in average 1.1 hours per day of exposure to sunlight. Mean standardized total patient satisfaction score was 28.8 (standard deviation [SD] 17.2 in flutamide group patients versus 18 (SD 15.5 in control group (P<0.01. Regardless of treatment group, the skin darkness assessed upon MASI scales was reduced over the treatment course (P<0.001. Using mixed effects, longitudinal modeling showed better treatment efficacy based on MASI scale for flutamide group compared to the hydroquinone group (P<0.05. However, longitudinal analysis of mexameter scores did not reveal any significant difference in melanin measurements between flutamide and hydroquinone.Conclusion: Topical flutamide appeared as effective as topical hydroquinone in treating melasma using mexameter assessment but with a better MASI improvement trend and higher patient satisfaction in flutamide treatment versus topical hydroquinone. As the present study is possibly the

  14. An audit on virological efficacy of anti-retroviral therapy in a specialist infectious disease clinic.

    LENUS (Irish Health Repository)

    Reyad, A

    2009-06-01

    We have assessed the efficacy of anti retroviral therapy (ART) using undetectable viral load (VL) (<50 RNA copies\\/ml) as a marker of virological success, in patients who have Human Immunodeficiency Virus (HIV) attending the Department of Infectious Disease. A cross-sectional review of patients\\' case notes was used to obtain their demographics and treatment details. 79% (253) of the hospital case notes of clinic population was available for analysis, which represents 90% of those receiving ART in the clinic. 166\\/253 of the cohort were receiving treatment at the time of this study and 95% (157\\/166) of these were on treatment for greater than 6 months. The total virological success rate is 93%, which is comparable to other centres and are as good as those from published clinical trials. 56% of those on therapy who have virological failure were Intravenous Drug Users (IVDUs). Case by case investigation for those with treatment failure is warranted.

  15. Randomized, controlled clinical trial evaluating the efficacy of pulsed signal therapy in dogs with osteoarthritis.

    Science.gov (United States)

    Sullivan, Meghan O; Gordon-Evans, Wanda J; Knap, Kim E; Evans, Richard B

    2013-04-01

    To evaluate the efficacy of pulsed signal therapy (PST) in reducing pain and increasing function in dogs with osteoarthritis (OA) using a randomized, blinded, controlled clinical trial. Randomized, controlled, blinded clinical trial. Adult dogs (n = 60) with moderate-to-severe clinical signs of OA. Dogs were randomized by age into 2 groups: dogs ≥ 9 years and dogs Goniometry and gait analysis were performed, and the Canine Brief Pain Inventory (CBPI) questionnaire was given to the owners to fill out without supervision. Outcome measures were repeated at the end of treatment (Day 11) and 6 weeks after beginning treatment (Day 42). The PST group performed significantly better than the control group as measured by the CBPI Severity and Interference scores (P Veterinary Surgeons.

  16. Anti-EGFR Therapy: Mechanism and Advances in Clinical Efficacy in Breast Cancer

    Directory of Open Access Journals (Sweden)

    John F. Flynn

    2009-01-01

    Full Text Available This review will focus on recent advances in the application of antiepidermal growth factor receptor (anti-EGFR for the treatment of breast cancer. The choice of EGFR, a member of the ErbB tyrosine kinase receptor family, stems from evidence pinpointing its role in various anti-EGFR therapies. Therefore, an increase in our understanding of EGFR mechanism and signaling might reveal novel targets amenable to intervention in the clinic. This knowledge base might also improve existing medical treatment options and identify research gaps in the design of new therapeutic agents. While the approved use of drugs like the dual kinase inhibitor Lapatinib represents significant advances in the clinical management of breast cancer, confirmatory studies must be considered to foster the use of anti-EGFR therapies including safety, pharmacokinetics, and clinical efficacy.

  17. Predictive genomics: a cancer hallmark network framework for predicting tumor clinical phenotypes using genome sequencing data.

    Science.gov (United States)

    Wang, Edwin; Zaman, Naif; Mcgee, Shauna; Milanese, Jean-Sébastien; Masoudi-Nejad, Ali; O'Connor-McCourt, Maureen

    2015-02-01

    Tumor genome sequencing leads to documenting thousands of DNA mutations and other genomic alterations. At present, these data cannot be analyzed adequately to aid in the understanding of tumorigenesis and its evolution. Moreover, we have little insight into how to use these data to predict clinical phenotypes and tumor progression to better design patient treatment. To meet these challenges, we discuss a cancer hallmark network framework for modeling genome sequencing data to predict cancer clonal evolution and associated clinical phenotypes. The framework includes: (1) cancer hallmarks that can be represented by a few molecular/signaling networks. 'Network operational signatures' which represent gene regulatory logics/strengths enable to quantify state transitions and measures of hallmark traits. Thus, sets of genomic alterations which are associated with network operational signatures could be linked to the state/measure of hallmark traits. The network operational signature transforms genotypic data (i.e., genomic alterations) to regulatory phenotypic profiles (i.e., regulatory logics/strengths), to cellular phenotypic profiles (i.e., hallmark traits) which lead to clinical phenotypic profiles (i.e., a collection of hallmark traits). Furthermore, the framework considers regulatory logics of the hallmark networks under tumor evolutionary dynamics and therefore also includes: (2) a self-promoting positive feedback loop that is dominated by a genomic instability network and a cell survival/proliferation network is the main driver of tumor clonal evolution. Surrounding tumor stroma and its host immune systems shape the evolutionary paths; (3) cell motility initiating metastasis is a byproduct of the above self-promoting loop activity during tumorigenesis; (4) an emerging hallmark network which triggers genome duplication dominates a feed-forward loop which in turn could act as a rate-limiting step for tumor formation; (5) mutations and other genomic alterations have

  18. Predictive Factors of Clinical Response of Infliximab Therapy in Active Nonradiographic Axial Spondyloarthritis Patients

    Directory of Open Access Journals (Sweden)

    Zhiming Lin

    2015-01-01

    Full Text Available Objectives. To evaluate the efficiency and the predictive factors of clinical response of infliximab in active nonradiographic axial spondyloarthritis patients. Methods. Active nonradiographic patients fulfilling ESSG criteria for SpA but not fulfilling modified New York criteria were included. All patients received infliximab treatment for 24 weeks. The primary endpoint was ASAS20 response at weeks 12 and 24. The abilities of baseline parameters and response at week 2 to predict ASAS20 response at weeks 12 and 24 were assessed using ROC curve and logistic regression analysis, respectively. Results. Of 70 axial SpA patients included, the proportions of patients achieving an ASAS20 response at weeks 2, 6, 12, and 24 were 85.7%, 88.6%, 87.1%, and 84.3%, respectively. Baseline MRI sacroiliitis score (AUC = 0.791; P=0.005, CRP (AUC = 0.75; P=0.017, and ASDAS (AUC = 0.778, P=0.007 significantly predicted ASAS20 response at week 12. However, only ASDAS (AUC = 0.696, P=0.040 significantly predicted ASAS20 response at week 24. Achievement of ASAS20 response after the first infliximab infusion was a significant predictor of subsequent ASAS20 response at weeks 12 and 24 (wald χ2=6.87, P=0.009, and wald χ2=5.171, P=0.023. Conclusions. Infliximab shows efficiency in active nonradiographic axial spondyloarthritis patients. ASDAS score and first-dose response could help predicting clinical efficacy of infliximab therapy in these patients.

  19. Prediction of higher cost of antiretroviral therapy (ART) according to clinical complexity. A validated clinical index.

    Science.gov (United States)

    Velasco, Cesar; Pérez, Inaki; Podzamczer, Daniel; Llibre, Josep Maria; Domingo, Pere; González-García, Juan; Puig, Inma; Ayala, Pilar; Martín, Mayte; Trilla, Antoni; Lázaro, Pablo; Gatell, Josep Maria

    2016-03-01

    The financing of antiretroviral therapy (ART) is generally determined by the cost incurred in the previous year, the number of patients on treatment, and the evidence-based recommendations, but not the clinical characteristics of the population. To establish a score relating the cost of ART and patient clinical complexity in order to understand the costing differences between hospitals in the region that could be explained by the clinical complexity of their population. Retrospective analysis of patients receiving ART in a tertiary hospital between 2009 and 2011. Factors potentially associated with a higher cost of ART were assessed by bivariate and multivariate analysis. Two predictive models of "high-cost" were developed. The normalized estimated (adjusted for the complexity scores) costs were calculated and compared with the normalized real costs. In the Hospital Index, 631 (16.8%) of the 3758 patients receiving ART were responsible for a "high-cost" subgroup, defined as the highest 25% of spending on ART. Baseline variables that were significant predictors of high cost in the Clinic-B model in the multivariate analysis were: route of transmission of HIV, AIDS criteria, Spanish nationality, year of initiation of ART, CD4+ lymphocyte count nadir, and number of hospital admissions. The Clinic-B score ranged from 0 to 13, and the mean value (5.97) was lower than the overall mean value of the four hospitals (6.16). The clinical complexity of the HIV patient influences the cost of ART. The Clinic-B and Clinic-BF scores predicted patients with high cost of ART and could be used to compare and allocate costs corrected for the patient clinical complexity. Copyright © 2015 Elsevier España, S.L.U. y Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

  20. The clinical efficacy of dietary fat restriction in treatment of dogs with intestinal lymphangiectasia.

    Science.gov (United States)

    Okanishi, H; Yoshioka, R; Kagawa, Y; Watari, T

    2014-01-01

    Intestinal lymphangiectasia (IL), a type of protein-losing enteropathy (PLE), is a dilatation of lymphatic vessels within the gastrointestinal tract. Dietary fat restriction previously has been proposed as an effective treatment for dogs with PLE, but limited objective clinical data are available on the efficacy of this treatment. To investigate the clinical efficacy of dietary fat restriction in dogs with IL that were unresponsive to prednisolone treatment or showed relapse of clinical signs and hypoalbuminemia when the prednisolone dosage was decreased. Twenty-four dogs with IL. Retrospective study. Body weight, clinical activity score, and hematologic and biochemical variables were compared before and 1 and 2 months after treatment. Furthermore, the data were compared between the group fed only an ultra low-fat (ULF) diet and the group fed ULF and a low-fat (LF) diet. Nineteen of 24 (79%) dogs responded satisfactorily to dietary fat restriction, and the prednisolone dosage could be decreased. Clinical activity score was significantly decreased after dietary treatment compared with before treatment. In addition, albumin (ALB), total protein (TP), and blood urea nitrogen (BUN) concentration were significantly increased after dietary fat restriction. At 2 months posttreatment, the ALB concentrations in the ULF group were significantly higher than that of the ULF + LF group. Dietary fat restriction appears to be an effective treatment in dogs with IL that are unresponsive to prednisolone treatment or that have recurrent clinical signs and hypoalbuminemia when the dosage of prednisolone is decreased. © 2014 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of American College of Veterinary Internal Medicine.

  1. Incorporating Experiential Learning Techniques to Improve Self-Efficacy in Clinical Special Care Dentistry Education.

    Science.gov (United States)

    Watters, Amber L; Stabulas-Savage, Jeanine; Toppin, James D; Janal, Malvin N; Robbins, Miriam R

    2015-09-01

    The New York University College of Dentistry has introduced a clinical rotation for fourth-year dental students that focuses on treating people with special health care needs (PSN). The aim of this study was to investigate the hypothesis that clinical experience in treating patients with special health care needs during predoctoral education is associated with increased self-assessed student ability and comfort and therefore self-efficacy. The study also investigated whether other characteristics, such as prior personal or volunteer experience with this population, service-mindedness, and/or the inclination to treat underserved populations, were associated with comfort in treating PSN. A survey was used to assess changes in students' perceived knowledge, beliefs, and attitudes regarding treating PSN before and after the clinical experience for July 2012-June 2013. The survey included questions about students' service-mindedness, comfort, perceptions of abilities of PSN and educational importance of learning to treat PSN, desire for clinical experience, and future intent or interest in treating PSN. Out of 364 students invited to participate, 127 surveys were returned, for a response rate of 34.9%. The results showed statistically significant increases on six items following training: impressions about the importance of oral health among PSN, comfort in treating people with cognitive disabilities and with medical complexities, intent to treat PSN in future practice, interest in including PSN in postgraduate training, and belief that PSN could be treated in the private practice setting. These students reported preferring to learn in the clinical setting over didactic instruction. This clinical experience was associated with improved self-efficacy in treating PSN and increased intentions to treat this population in future practice. Improvements were particularly evident among those with the least prior experience with PSN and were independent of other aspects of the

  2. Comparison of Efficacy and Threat Perception Processes in Predicting Smoking among University Students Based on Extended Parallel Process Model

    Directory of Open Access Journals (Sweden)

    S. Bashirian

    2014-04-01

    Full Text Available Introduction & Objective: The survey of smoking as the most toxic, common and cheapest ad-diction, and its psychological and demographic variables especially among the youth who are efficient and constructive individuals of the society is of great importance. This study was performed to compare efficacy and threat perception in predicting cigarette smoking among university students based on Expended Parallel Process Model (EPPM. Material & Methods: This cross sectional descriptive study was carried out on 700 college stu-dents of Hamadan recruited with a stratified sampling method. The participants completed a self-administered questionnaire including demographic characteristics, smoking status and EPPM Data analysis was done with the SPSS software (version 16, using t-test, one way ANOVA, Pierson correlation and logistic regression methods. Results: The average scores of threat and efficacy perception were 39.7 and 38.6, respectively. The prevalence of cigarette smoking among participants was 27.1 percent. Also, there were significant differences between the average score of efficacy perception and age, gender, his-tory of drug abuse and dwelling of students (P<0.05. Efficacy and threat perception both predicted student cigarette smoking. Conclusions: Cognitive mediating process of threat perception was a more powerful predictor of cigarette smoking as an unsafe behavior. Therefore, increasing self efficacy and response efficacy of university students aimed at facilitating the acceptance of safe behavior could be note-worthy as a principle in education. (Sci J Hamadan Univ Med Sci 2014; 21 (1:58-65

  3. Comparing student clinical self-efficacy and team process outcomes for a DEU, blended, and traditional clinical setting: A quasi-experimental research study.

    Science.gov (United States)

    Plemmons, Christina; Clark, Michele; Feng, Du

    2018-03-01

    Clinical education is vital to both the development of clinical self-efficacy and the integration of future nurses into health care teams. The dedicated education unit clinical teaching model is an innovative clinical partnership, which promotes skill development, professional growth, clinical self-efficacy, and integration as a team member. Blended clinical teaching models are combining features of the dedicated education unit and traditional clinical model. The aims of this study are to explore how each of three clinical teaching models (dedicated education unit, blended, traditional) affects clinical self-efficacy and attitude toward team process, and to compare the dedicated education unit model and blended model to traditional clinical. A nonequivalent control-group quasi-experimental design was utilized. The convenience sample of 272 entry-level baccalaureate nursing students included 84 students participating in a dedicated education unit model treatment group, 66 students participating in a blended model treatment group, and 122 students participating in a traditional model control group. Perceived clinical self-efficacy was evaluated by the pretest/posttest scores obtained on the General Self-Efficacy scale. Attitude toward team process was evaluated by the pretest/posttest scores obtained on the TeamSTEPPS® Teamwork Attitude Questionnaire. All three clinical teaching models resulted in significant increases in both clinical self-efficacy (p=0.04) and attitude toward team process (p=0.003). Students participating in the dedicated education unit model (p=0.016) and students participating in the blended model (pteam process among entry-level baccalaureate nursing students. Copyright © 2017 Elsevier Ltd. All rights reserved.

  4. Efficacy of clinical diagnostic procedures utilized in nuclear medicine. Final report, August 1977-November 30, 1983

    International Nuclear Information System (INIS)

    Saenger, E.L.

    1986-06-01

    This report describes a study of 2023 patients comparing two methods of evaluating the efficacy of lung scanning in patients suspected of having pulmonary embolism (PE). Only the referring physicians determined the probability of the most important (MI) and most likely (ML) diagnoses, and management, before and after lung scanning. A logistic regression model was developed for the probability of a signout diagnosis of PE. Equal patient groups tested the validity of the regression equations for the probability of PE both before and after the lung scan. The models developed on half the data (Group I) were then tested on the second half of the data set (Group II) to determine their ability to predict with similar results. This shows that the lung scan classifies PE and NOT PE patients well. Entropy minimax pattern detection (EMPD) attempts to predict the diagnosis and management from prior patient attributes. In 2023 cases, attributes alone could not iminate the use of lung scans for all patients. Comparing the two analytic methods, the predictive value, sensitivity, specificity and accuracy of each method are similar. However, EMPD predicts on a relatively small percent of cases (40% prior and 715 post scan) while logistic regression equations predict on 100% of cases. 29 refs., 2 figs., 16 tabs

  5. Clinical efficacy of gene-modified stem cells in adenosine deaminase–deficient immunodeficiency

    Science.gov (United States)

    Shaw, Kit L.; Garabedian, Elizabeth; Mishra, Suparna; Barman, Provaboti; Davila, Alejandra; Carbonaro, Denise; Shupien, Sally; Silvin, Christopher; Geiger, Sabine; Nowicki, Barbara; Smogorzewska, E. Monika; Brown, Berkley; Wang, Xiaoyan; de Oliveira, Satiro; Choi, Yeong; Ikeda, Alan; Terrazas, Dayna; Fu, Pei-Yu; Yu, Allen; Fernandez, Beatriz Campo; Cooper, Aaron R.; Engel, Barbara; Podsakoff, Greg; Balamurugan, Arumugam; Anderson, Stacie; Muul, Linda; Jagadeesh, G. Jayashree; Kapoor, Neena; Tse, John; Moore, Theodore B.; Purdy, Ken; Rishi, Radha; Mohan, Kathey; Skoda-Smith, Suzanne; Buchbinder, David; Abraham, Roshini S.; Scharenberg, Andrew; Yang, Otto O.; Cornetta, Kenneth; Gjertson, David; Hershfield, Michael; Sokolic, Rob; Candotti, Fabio

    2017-01-01

    BACKGROUND. Autologous hematopoietic stem cell transplantation (HSCT) of gene-modified cells is an alternative to enzyme replacement therapy (ERT) and allogeneic HSCT that has shown clinical benefit for adenosine deaminase–deficient (ADA-deficient) SCID when combined with reduced intensity conditioning (RIC) and ERT cessation. Clinical safety and therapeutic efficacy were evaluated in a phase II study. METHODS. Ten subjects with confirmed ADA-deficient SCID and no available matched sibling or family donor were enrolled between 2009 and 2012 and received transplantation with autologous hematopoietic CD34+ cells that were modified with the human ADA cDNA (MND-ADA) γ-retroviral vector after conditioning with busulfan (90 mg/m2) and ERT cessation. Subjects were followed from 33 to 84 months at the time of data analysis. Safety of the procedure was assessed by recording the number of adverse events. Efficacy was assessed by measuring engraftment of gene-modified hematopoietic stem/progenitor cells, ADA gene expression, and immune reconstitution. RESULTS. With the exception of the oldest subject (15 years old at enrollment), all subjects remained off ERT with normalized peripheral blood mononuclear cell (PBMC) ADA activity, improved lymphocyte numbers, and normal proliferative responses to mitogens. Three of nine subjects were able to discontinue intravenous immunoglobulin replacement therapy. The MND-ADA vector was persistently detected in PBMCs (vector copy number [VCN] = 0.1–2.6) and granulocytes (VCN = 0.01–0.3) through the most recent visits at the time of this writing. No patient has developed a leukoproliferative disorder or other vector-related clinical complication since transplant. CONCLUSION. These results demonstrate clinical therapeutic efficacy from gene therapy for ADA-deficient SCID, with an excellent clinical safety profile. TRIAL REGISTRATION. ClinicalTrials.gov NCT00794508. FUNDING. Food and Drug Administration Office of Orphan Product

  6. Clinical Efficacy of Acupuncture on Rheumatoid Arthritis and Associated Mechanisms: A Systemic Review

    Directory of Open Access Journals (Sweden)

    Pei-Chi Chou

    2018-01-01

    Full Text Available Objective. The objective of this review is to investigate the detailed existing scientific information about the clinical efficacy of acupuncture on rheumatoid arthritis (RA conditions and to reveal the proposed mechanisms. Methods. We searched the PubMed, EMBASE, Cochrane, AMED (Allied and Complementary Medicine, NCCAM (The National Center for Complementary and Alternative Medicine, and CNKI (China National Knowledge Infrastructure databases to identify relevant monographs and related references from 1974 to 2018. Chinese journals and theses/dissertations were hand searched. Results. 43 studies were recruited. Each research was analyzed for study design, subject characteristics, intervention, selected acupoints, assessment parameters, proposed mechanisms, and results/conclusions. Conclusions. In our review, we concluded that acupuncture alone or combined with other treatment modalities is beneficial to the clinical conditions of RA without adverse effects reported and can improve function and quality of life and is worth trying. Several important possible mechanisms were summarized including anti-inflammatory effect, antioxidative effect, and regulation of immune system function. However, there is still inconsistency regarding the clinical efficacy and lack of well-designed human/animal double-blinded RCTs. Future discussion for further agreement on taking traditional Chinese medicine (TCM theory into consideration as much as possible is a top priority.

  7. Comparison of clinical efficacy and side effects for bitemporal and bifrontal electrode placement in electroconvulsive therapy.

    Science.gov (United States)

    Bakewell, Catherine J; Russo, Joan; Tanner, Craig; Avery, David H; Neumaier, John F

    2004-09-01

    Bifrontal (BF) placement of electrodes in electroconvulsive therapy (ECT) has become a popular alternative to bitemporal (BT) placement. This study compares the clinical efficacy, side effects, and rehospitalization rates of BT and BF electrode placement in a community hospital setting. Charts from 76 patients receiving ECT treatments at Harborview Medical Center from 1994 to 2000 were reviewed to extract data on the characteristics of the course of ECT, clinical response, total headaches, narcotic and nonsteroidal anti-inflammatory drug doses, as well as documentation of confusion, disorientation, memory loss, and treatment emergent need for assistance with activities of daily living. The BT patients experienced more clinical improvement during their stay (a 7-point greater change in Psychiatric Symptom Assessment Scale score, P < 0.05) and were significantly less likely to be rehospitalized within a 1-year time frame (odds ratio = 4.9, P = <0.05), even after controlling for relevant covariates. Although the two patient groups had equal rates of headache and analgesic administration, the BT placement caused significantly more cognitive impairment. This study suggests that BT electrode placement offers better efficacy but modestly greater cognitive impairment than BF electrode placement.

  8. Management of advanced pancreatic cancer with gemcitabine plus erlotinib: efficacy and safety results in clinical practice.

    Science.gov (United States)

    Diaz Beveridge, Robert; Alcolea, Vicent; Aparicio, Jorge; Segura, Ángel; García, Jose; Corbellas, Miguel; Fonfría, María; Giménez, Alejandra; Montalar, Joaquin

    2014-01-10

    The combination of gemcitabine and erlotinib is a standard first-line treatment for unresectable, locally advanced or metastatic pancreatic cancer. We reviewed our single centre experience to assess its efficacy and toxicity in clinical practice. Clinical records of patients with unresectable, locally advanced or metastatic pancreatic cancer who were treated with the combination of gemcitabine and erlotinib were reviewed. Univariate survival analysis and multivariate analysis were carried out to indentify independent predictors factors of overall survival. Our series included 55 patients. Overall disease control rate was 47%: 5% of patients presented complete response, 20% partial response and 22% stable disease. Median overall survival was 8.3 months). Cox regression analysis indicated that performance status and locally advanced versus metastatic disease were independent factors of overall survival. Patients who developed acne-like rash toxicity, related to erlotinib administration, presented a higher survival than those patients who did not develop this toxicity. Gemcitabine plus erlotinib doublet is active in our series of patients with advanced pancreatic cancer. This study provides efficacy and safety results similar to those of the pivotal phase III clinical trial that tested the same combination.

  9. Clinical efficacy of Ranibizumab in the treatment of wet age-related macular degeneration

    Directory of Open Access Journals (Sweden)

    Ling-Jun Wei

    2017-12-01

    Full Text Available AIM:To analyze the clinical efficacy of Ranibizumab in the treatment of wet age-related macular degeneration(ARMD.METHODS: Clinical data of patients with wet age-related macular degeneration received treatment of ranibizumab at our hospital from 2015 to 2017 were analyzed. At 1mo after treatment, the clinical efficacy, ocular hemodynamics and ocular inflammation were evaluated. RESULTS: A total of 41 patients were analyzed. After treatment, patients got significantly increased in LogMAR(0.651±0.067 vs 0.321±0.049; t=25.460, Pvs 452.9±69.8μm; t=15.740, Pvs 16.1±3.5ng/L; t=3.563, Pvs 13.8±2.5ng/L; t=3.467, PP>0.05. CONCLUSION: In the treatment of wet age-related macular degeneration, the ranibizumab shows a good therapeutic effect without serious adverse drug reactions.

  10. Clinical efficacy of valsartan combined with hydrochlorothiazide in treatment of elderly hypertension

    Directory of Open Access Journals (Sweden)

    Ya-Ting Shao

    2016-06-01

    Full Text Available Objective: To explore the clinical efficacy of valsartan combined with hydrochlorothiazide in the treatment of elderly hypertension. Methods: A total of 150 elderly patients with primary hypertension who were admitted in our hospital from January, 2015 to January, 2016 were included in the study and randomized into the observation group and the control group. The patients in the control group were given valsartan, 80 mg/time, 1 time/d. On this basis, the patients in the observation group were given additional hydrochlorothiazide 12.5 mg/time, 1 time/d. The patients in the two groups were administered with drugs in the morning. Six-month treatment was regarded as one course. The change of 24 h ambulatory blood pressure before and after treatment was detected, and the efficacy was evaluated. The heart color ultrasound was used to detect LVM and LVMI before and after treatment in the two groups. Results: The total effective rate in the observation group (90.7% was significantly superior to that in the control group (70.7% (P<0.05. The mean SBP and DBP 24h after treatment in the two groups were significantly reduced when compared with before treatment (P<0.05, and those in the observation group were significantly superior to those in the control group (P<0.05. LVM and LVMI after treatment in the two groups were significantly reduced when compared with before treatment (P<0.05, and those in the observation group were significantly superior to those in the control group (P<0.05. Conclusions: The combination of valsartan and hydrochlorothiazide in the treatment of elderly hypertension can effectively enhance the clinical efficacy, and effectively control the blood pressure. It is superior to that by a single drug; therefore, and deserves to be widely recommended in the clinic.

  11. Clinical evaluation of the efficacy of removing microorganisms to disinfect patient-derived dental impressions.

    Science.gov (United States)

    Egusa, Hiroshi; Watamoto, Takao; Matsumoto, Takuya; Abe, Keiko; Kobayashi, Munemasa; Akashi, Yoshihiro; Yatani, Hirofumi

    2008-01-01

    Disinfection of dental impressions is an indispensable procedure for the control of cross-contamination; however, there is limited information on the efficacy of disinfection under clinical conditions. The objective of this study was to clinically evaluate the disinfection efficacy of commercially available agents in removing oral pathogens from patient-derived impressions. Impressions from 54 patients were divided into groups and either left undisinfected or underwent 1 of 5 disinfection treatments: (1) 2% glutaraldehyde (GA), (2) 1% sodium hypochlorite (SH), (3) 0.25% benzalkonium chloride (BC), (4) 1 ppm ozonated water (OW), or (5) the Hygojet/MD520 system (HJ). An impression culture technique using a brain heart infusion agar medium was used to visualize the microbial contamination on the surface of the impression cultures. The persistent presence of oral pathogens on the impression cultures was examined using selective isolation agar plates. The isolation frequencies of streptococci, staphylococci, Candida, methicillin-resistant Staphylococcus aureus, and Pseudomonas aeruginosa species from undisinfected impressions were 100%, 55.6%, 25.9%, 25.9% and 5.6%, respectively. Disinfection with HJ and BC removed the microorganisms with the greatest efficacy, followed by GA, SH, and OW. Potential bacterial contamination could be detected even after disinfection had been performed. Combined use of BC plus GA or SH removed oral pathogens almost completely from dental impressions. This investigation showed that potential contaminants are still present, even after general disinfection procedures. Therefore, either HJ or the combined use of BC with GA or SH is recommended for clinical and laboratory use.

  12. Florfenicol - pharmacodynamic, pharmacokinetics and clinical efficacy of oral formulations in domestic animals: A systematic review

    Directory of Open Access Journals (Sweden)

    Ščuka Leon

    2005-01-01

    Full Text Available Porcine respiratory disease complex (PRDC is a major economic problem for swine producers world-wide. Pharmacodynamic, pharmacokinetics and clinical efficacy of florfenicol oral formulations in domestic animals were evaluated. For this purpose the systematic review and meta-analysis were done. In vitro efficacy of florfenicol showed that this drug is highly effective against most important respiratory pathogens. All these facts are shown in our survey. Three studies in pigs were relevant to include in the meta-analysis, which showed that results in the florfenicol group were better than in comparative control groups in all observed parameters: clinical signs, lung lesions and resolution of Actinobacillus pleuropneumoniae (P<0,001. A second meta-analysis with 7 studies showed that the usage of florfenicol reduces mortality in pig herds with PRDC (P<0.05. Other field trials in pigs using florfenicol oral forms where reviewed. After treatment with florfenicol oral solution there was a significant drop of mortality in both groups of pigs (P<0.01; eg. one using florfenicol oral solution in treating PRDC (n=85 and another mixed pneumoenteric infection (n=54. Analysis of data when using premix in pigs (n=118 also suggests that a medicated premix has a favorable anti-infectious effect on pigs, irrespective of the group of animals or the evolution stage of the disease. Finally, favorable effect of florfenicol in treating swine ileitis was also presented. Regarding their pharmacokinetics, in vitro and clinical efficacy of florfenicol oral forms, they should be considered as a powerful tool for combating complex infections that are frequently met in intensive animal production.

  13. Do Urinary Cystine Parameters Predict Clinical Stone Activity?

    Science.gov (United States)

    Friedlander, Justin I; Antonelli, Jodi A; Canvasser, Noah E; Morgan, Monica S C; Mollengarden, Daniel; Best, Sara; Pearle, Margaret S

    2018-02-01

    An accurate urinary predictor of stone recurrence would be clinically advantageous for patients with cystinuria. A proprietary assay (Litholink, Chicago, Illinois) measures cystine capacity as a potentially more reliable estimate of stone forming propensity. The recommended capacity level to prevent stone formation, which is greater than 150 mg/l, has not been directly correlated with clinical stone activity. We investigated the relationship between urinary cystine parameters and clinical stone activity. We prospectively followed 48 patients with cystinuria using 24-hour urine collections and serial imaging, and recorded stone activity. We compared cystine urinary parameters at times of stone activity with those obtained during periods of stone quiescence. We then performed correlation and ROC analysis to evaluate the performance of cystine parameters to predict stone activity. During a median followup of 70.6 months (range 2.2 to 274.6) 85 stone events occurred which could be linked to a recent urine collection. Cystine capacity was significantly greater for quiescent urine than for stone event urine (mean ± SD 48 ± 107 vs -38 ± 163 mg/l, p stone activity (r = -0.29, p r = -0.88, p r = -0.87, p stone quiescence. Decreasing the cutoff to 90 mg/l or greater improved sensitivity to 25.2% while maintaining specificity at 90.9%. Our results suggest that the target for capacity should be lower than previously advised. Copyright © 2018 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

  14. Efficacy of chemomechanical caries removal in reducing cariogenic microbiota: a randomized clinical trial

    OpenAIRE

    AMMARI, Michelle Mikhael; MOLITERNO, Luiz Flávio Martins; HIRATA JÚNIOR, Raphael; SÉLLOS, Mariana Canano; SOVIERO, Vera Mendes; COUTINHO FILHO, Wagner Pereira

    2014-01-01

    The aim of this study was to compare the efficacy of chemochemical methods (Carisolv™ and Papacárie®) versus the manual method (excavators) in reducing the cariogenic microbiota in dentine caries of primary teeth. Forty-six healthy children (5 to 9 years old) having at least one primary tooth with a cavitated dentine carious lesion were included in the study. The teeth presented no clinical or radiographic signs of pulpal involvement. The sample of 74 teeth was randomly divided into thr...

  15. The roles of self-efficacy and motivation in the prediction of short- and long-term adherence to exercise among patients with coronary heart disease.

    Science.gov (United States)

    Slovinec D'Angelo, Monika E; Pelletier, Luc G; Reid, Robert D; Huta, Veronika

    2014-11-01

    Poor adherence to regular exercise is a documented challenge among people with heart disease. Identifying key determinants of exercise adherence and distinguishing between the processes driving short- and long-term adherence to regular exercise is a valuable endeavor. The purpose of the present study was to test a model of exercise behavior change, which incorporates motivational orientations and self-efficacy for exercise behavior, in the prediction of short- and long-term exercise adherence. Male and female patients (N = 801) hospitalized for coronary heart disease were recruited from 3 tertiary care cardiac centers and followed for a period of 1 year after hospital discharge. A prospective, longitudinal design was used to examine the roles of motivation and self-efficacy (measured at recruitment and at 2 and 6 months after discharge) in the prediction of exercise behavior at 6 and 12 months. Baseline measures of exercise and clinical and demographic covariates were included in the analyses. Structural equation modeling showed that both autonomous motivation and self-efficacy were important determinants of short-term (6-month) exercise behavior regulation, but that only autonomous motivation remained a significant predictor of long-term (12-month) exercise behavior. Self-efficacy partially mediated the relationship between motivation for exercise and 6-month exercise behavior. This research confirmed the roles of autonomous motivation and self-efficacy in the health behavior change process and emphasized the key function of autonomous motivation in exercise maintenance. Theoretical and cardiac rehabilitation program applications of this research are discussed. PsycINFO Database Record (c) 2014 APA, all rights reserved.

  16. Clinical efficacy and safety of fluoxetine in generalized anxiety disorder in Chinese patients

    Directory of Open Access Journals (Sweden)

    Zou C

    2013-11-01

    Full Text Available Chuan Zou,1 Xiang Ding,1 Joseph H Flaherty,2 Birong Dong1 1The Center of Gerontology and Geriatrics, West China Hospital, Sichuan University, Chengdu, People's Republic of China; 2St Louis University, St Louis, MO, USA Background: Generalized anxiety disorder (GAD is a prevalent, disabling disease and is highly comorbid with other psychiatric disorders both in Western countries and the People's Republic of China. Fluoxetine, a selective inhibitor of serotonin reuptake (SSRI, is widely utilized in the management of GAD in clinical practice despite the lack of strong evidence. This article reviews fluoxetine trials to investigate fluoxetine's efficacy and tolerability in Chinese patients with GAD. Methods: A literature review was conducted using the following databases up to and including April 2013: Chinese BioMedical Literature, China National Knowledge Infrastructure, EMBASE, MEDLINE, and PsycINFO. We selected clinical studies that utilized fluoxetine for GAD in which all participants were Chinese. Results: Fifteen open-label, non-placebo trials were identified and analyzed; eleven anxiolytics were compared with fluoxetine separately. Short-term efficacy of fluoxetine had been established in these open-label, head-to-head controlled trials. Fluoxetine had rapid onset of action (approximately 1–2 weeks and seemed to be effective in maintenance treatment. Fluoxetine was generally well-tolerated with the most common side effect of dry month and nausea. Compared to other anxiolytic agents, fluoxetine was equivalent with all of the comparative anxiolytics in terms of efficacy except mirtazapine which showed conflicting results with fluoxetine in two studies. In terms of side effects, fluoxetine was better tolerated than diazepam, doxepine, and amitriptyline, less tolerated than escitalopram, and had similar tolerability with duloxetine as well as alprazolam. Conclusion: Given the high risk of bias of the included studies, the overall small sample

  17. Predicting Sense of Efficacy and Teachers' Job Satisfaction of Teachers from Their Perceptions of the Decision Participation

    Science.gov (United States)

    Van Dat, Tran

    2016-01-01

    This study examines the hypothesis that teachers' perceptions of the decision participation may predict their teaching efficacy and job satisfaction. It examines data obtained from 197 secondary school teachers from 6 secondary schools to identify how teachers' perception of the decision participation varies, and the extent to which this predict…

  18. Analysis of Academic Self-Efficacy, Self-Esteem and Coping with Stress Skills Predictive Power on Academic Procrastination

    Science.gov (United States)

    Kandemir, Mehmet; Ilhan, Tahsin; Ozpolat, Ahmed Ragip; Palanci, Mehmet

    2014-01-01

    The goal of this research is to analyze the predictive power level of academic self-efficacy, self-esteem and coping with stress on academic procrastination behavior. Relational screening model is used in the research whose research group is made of 374 students in Kirikkale University, Education Faculty in Turkey. Students in the research group…

  19. Sensitivity Analysis of Per-Protocol Time-to-Event Treatment Efficacy in Randomized Clinical Trials

    Science.gov (United States)

    Gilbert, Peter B.; Shepherd, Bryan E.; Hudgens, Michael G.

    2013-01-01

    Summary Assessing per-protocol treatment effcacy on a time-to-event endpoint is a common objective of randomized clinical trials. The typical analysis uses the same method employed for the intention-to-treat analysis (e.g., standard survival analysis) applied to the subgroup meeting protocol adherence criteria. However, due to potential post-randomization selection bias, this analysis may mislead about treatment efficacy. Moreover, while there is extensive literature on methods for assessing causal treatment effects in compliers, these methods do not apply to a common class of trials where a) the primary objective compares survival curves, b) it is inconceivable to assign participants to be adherent and event-free before adherence is measured, and c) the exclusion restriction assumption fails to hold. HIV vaccine efficacy trials including the recent RV144 trial exemplify this class, because many primary endpoints (e.g., HIV infections) occur before adherence is measured, and nonadherent subjects who receive some of the planned immunizations may be partially protected. Therefore, we develop methods for assessing per-protocol treatment efficacy for this problem class, considering three causal estimands of interest. Because these estimands are not identifiable from the observable data, we develop nonparametric bounds and semiparametric sensitivity analysis methods that yield estimated ignorance and uncertainty intervals. The methods are applied to RV144. PMID:24187408

  20. Safety and clinical efficacy of golimumab in the treatment of arthritides

    Directory of Open Access Journals (Sweden)

    Ismail Simsek

    2010-09-01

    Full Text Available Ismail Simsek, Yusuf YaziciNew York University School of Medicine, NYU Hospital for Joint Diseases, New York, USAAbstract: Golimumab is a human anti-tumor necrosis factor (TNF-alpha monoclonal antibody that was recently approved for the treatment of patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. This review covers the published clinical trial data on the use of golimumab for the approved indications mentioned above with respect to efficacy and safety. The various ongoing trials for golimumab have yielded promising results in terms of efficacy and safety in methotrexate-naive and -resistant patients with rheumatoid arthritis, as well as in patients who were previously treated with other anti-TNF agents. In addition, the efficacy of golimumab in psoriatic arthritis and ankylosing spondylitis has also been demonstrated. The real safety information will be available only once the drug has been used in many more patients, who frequently have comorbid conditions.Keywords: arthritis, rheumatoid, psoriatic arthritis, ankylosing spondylitis

  1. The pharmacokinetics and clinical efficacy of AVP-825: a potential advancement for acute treatment of migraine.

    Science.gov (United States)

    Cady, Roger

    2015-01-01

    Oral triptans have dominated the prescription market for acute treatment of migraine for nearly 25 years. Today, patients often express dissatisfaction with prescribed acute treatment in part because they do not have confidence that the therapy will provide consistent efficacy over time. Major limitations to sustained successful use of oral triptans are their relatively slow onset of meaningful clinical benefit and variable absorption/efficacy due to impaired gastrointestinal function during migraine. AVP-825, a new intranasal delivery system for sumatriptan , may be an effective alternative to oral triptans. This article reviews AVP-825, which deposits low-dose sumatriptan powder deep into the vascular mucosa of the posterior nose, allowing rapid absorption of drug into the systemic circulation. Studies suggest that AVP-825 is a highly effective, well-tolerated acute treatment for episodic migraine. Oral triptans are limited in providing effective patient-centered outcomes to migraine patients. Failed or suboptimal abortive treatment of migraine is a major driver of migraine chronification and increases in healthcare costs. AVP-825 is an easy to use, novel, breath-powered intranasal delivery system that provides early onset of efficacy with low systemic drug exposure and few triptan-associated adverse events. AVP-825 will be a welcomed therapeutic tool for the acute treatment of migraine.

  2. Short Sleep Times Predict Obesity in Internal Medicine Clinic Patients

    Science.gov (United States)

    Buscemi, Dolores; Kumar, Ashwani; Nugent, Rebecca; Nugent, Kenneth

    2007-01-01

    Study Objectives: Epidemiological studies have demonstrated an association between short sleep times and obesity as defined by body mass index (BMI). We wanted to determine whether this association occurs in patients with chronic medical diagnoses since the number of confounding factors is likely higher in patients than the general population. Methods: Two hundred patients attending internal medicine clinics completed a survey regarding sleep habits, lifestyle characteristics, and medical diagnoses. An independent surveyor collected the information on the questionnaires and reviewed the medical records. Height and weight were measured by clinic personnel. Data were analyzed with multivariate logistic regression. Results: Subjects with short sleep times (< 7 hours) had an increased likelihood of obesity as defined by a BMI ≥ 30 kg/m2 when compared to the reference group of (8, 9] hours (odds ratio 2.93; 95% confidence interval, 1.06–8.09). There was a U-shaped relationship between obesity and sleep time in women but not in men. Young age (18 to 49 years), not smoking, drinking alcohol, hypertension, diabetes, and sleep apnea were also associated with obesity in the overall model. Conclusions: This study demonstrates an association between short sleep times and obesity in undifferentiated patients attending an internal medicine clinic using models adjusting for age, lifestyle characteristics, and some medical diagnoses. The U-shaped relationship in women suggests that sleep patterns may have gender specific associations. These observations provide the background for therapeutic trials in weight loss in patients with established medical problems. Citation: Buscemi D; Kumar A; Nugent R; Nugent K. Short sleep times predict obesity in internal medicine clinic patients. J Clin Sleep Med 2007;3(7):681–688. PMID:18198800

  3. Clinical formulas, mother's opinion and ultrasound in predicting birth weight

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    Maria Regina Torloni

    Full Text Available CONTEXT AND OBJECTIVE: Accurate fetal weight estimation is important for labor and delivery management. So far, there has not been any conclusive evidence to indicate that any technique for fetal weight estimation is superior to any other. Clinical formulas for fetal weight estimation are easy to use but have not been extensively studied in the literature. This study aimed to evaluate the accuracy of clinical formulas for fetal weight estimation compared to maternal and ultrasound estimates. DESIGN AND SETTING: Prospective study involving 100 full-term, cephalic, singleton pregnancies delivered within three days of fetal weight estimation. The setting was a tertiary public teaching hospital in São Paulo, Brazil. METHODS: Upon admission, the mother's opinion about fetal weight was recorded. Symphyseal-fundal height and abdominal girth were measured and two formulas were used to calculate fetal weight. An ultrasound scan was then performed by a specialist to estimate fetal weight. The four estimates were compared with the birth weight. The accuracy of the estimates was assessed by calculating the percentage that was within 10% of actual birth weight for each method. The chi-squared test was used for comparisons and p < 0.05 was considered significant. RESULTS: The birth weight was correctly estimated (± 10% in 59%, 57%, 61%, and 65% of the cases using the mother's estimate, two clinical formulas, and ultrasound estimate, respectively. The accuracy of the four methods did not differ significantly. CONCLUSION: Clinical formulas for fetal weight prediction are as accurate as maternal and ultrasound estimates.

  4. Clinical efficacy of raltegravir against B and non-B subtype HIV-1 in phase III clinical studies.

    Science.gov (United States)

    Rockstroh, Jürgen K; Teppler, Hedy; Zhao, Jing; Sklar, Peter; Miller, Michael D; Harvey, Charlotte M; Strohmaier, Kim M; Leavitt, Randi Y; Nguyen, Bach-Yen T

    2011-07-17

    We evaluated the long-term efficacy of raltegravir according to HIV-1 subtype (B and non-B) using data from three phase III studies in treatment-experienced (BENCHMRK-1 and 2) and treatment-naive (STARTMRK) HIV-infected patients. HIV-1 subtypes were identified from baseline plasma specimens using genotypic data of the PhenoSense GT test (Monogram Biosciences, South San Francisco, California, USA). Non-B subtypes were combined for the current analyses due to small numbers of each specific subtype. An observed failure approach was used (only discontinuations due to lack of efficacy were treated as failures). Resistance evaluation was performed in patients with documented virologic failure. Seven hundred and forty-three patients received raltegravir and 519 received comparator (efavirenz in STARTMRK; optimized background therapy in BENCHMRK). Non-B subtype virus (A, A/C, A/D, A/G, A1, AE, AG, B/G, BF, C, D, D/F, F, F1, G, and complex) was isolated at baseline in 98 (13%) raltegravir recipients and 62 (12%) comparator recipients. Subtypes AE and C were most common, isolated in 41 and 43 patients, respectively. The proportion of raltegravir recipients achieving HIV RNA less than 50 copies/ml was similar between non-B and B subtypes (STARTMRK: 94.5 vs. 88.7%; BENCHMRK-1 and 2: 66.7 vs. 60.7%); change in CD4 cell count also was similar between non-B and B subtypes (STARTMRK: 243 vs. 221 cells/μl; BENCHMRK-1 and 2: 121 vs. 144 cells/μl). Phenotypic resistance to raltegravir in non-B virus was associated with integrase mutations observed previously in subtype B virus. In phase III studies in treatment-naive and treatment-experienced patients, raltegravir showed comparable and potent clinical efficacy against B and non-B HIV-1 subtypes.

  5. How well does Invisalign work? A prospective clinical study evaluating the efficacy of tooth movement with Invisalign.

    Science.gov (United States)

    Kravitz, Neal D; Kusnoto, Budi; BeGole, Ellen; Obrez, Ales; Agran, Brent

    2009-01-01

    The purpose of this prospective clinical study was to evaluate the efficacy of tooth movement with removable polyurethane aligners (Invisalign, Align Technology, Santa Clara, Calif). The study sample included 37 patients treated with Anterior Invisalign. Four hundred one anterior teeth (198 maxillary and 203 mandibular) were measured on the virtual Treat models. The virtual model of the predicted tooth position was superimposed over the virtual model of the achieved tooth position, created from the posttreatment impression, and the 2 models were superimposed over their stationary posterior teeth by using ToothMeasure, Invisalign's proprietary superimposition software. The amount of tooth movement predicted was compared with the amount achieved after treatment. The types of movements studied were expansion, constriction, intrusion, extrusion, mesiodistal tip, labiolingual tip, and rotation. The mean accuracy of tooth movement with Invisalign was 41%. The most accurate movement was lingual constriction (47.1%), and the least accurate movement was extrusion (29.6%)- specifically, extrusion of the maxillary (18.3%) and mandibular (24.5%) central incisors, followed by mesiodistal tipping of the mandibular canines (26.9%). The accuracy of canine rotation was significantly lower than that of all other teeth, with the exception of the maxillary lateral incisors. At rotational movements greater than 15 degrees, the accuracy of rotation for the maxillary canines fell significantly. Lingual crown tip was significantly more accurate than labial crown tip, particularly for the maxillary incisors. There was no statistical difference in accuracy between maxillary and mandibular teeth of the same tooth type for any movements studied. We still have much to learn regarding the biomechanics and efficacy of the Invisalign system. A better understanding of Invisalign's ability to move teeth might help the clinician select suitable patients for treatment, guide the proper sequencing of

  6. Review article. Predicting disease onset in clinically healthy people

    Directory of Open Access Journals (Sweden)

    Zeliger . Harold I.

    2016-06-01

    Full Text Available Virtually all human disease is induced by oxidative stress. Oxidative stress, which is caused by toxic environmental exposure, the presence of disease, lifestyle choices, stress, chronic inflammation or combinations of these, is responsible for most disease. Oxidative stress from all sources is additive and it is the total oxidative stress from all sources that induces the onset of most disease. Oxidative stress leads to lipid peroxidation, which in turn produces Malondialdehyde. Serum malondialdehyde level is an additive parameter resulting from all sources of oxidative stress and, therefore, is a reliable indicator of total oxidative stress which can be used to predict the onset of disease in clinically asymptomatic individuals and to suggest the need for treatment that can prevent much human disease.

  7. A clinical tool for predicting survival in ALS.

    Science.gov (United States)

    Knibb, Jonathan A; Keren, Noa; Kulka, Anna; Leigh, P Nigel; Martin, Sarah; Shaw, Christopher E; Tsuda, Miho; Al-Chalabi, Ammar

    2016-12-01

    Amyotrophic lateral sclerosis (ALS) is a progressive and usually fatal neurodegenerative disease. Survival from diagnosis varies considerably. Several prognostic factors are known, including site of onset (bulbar or limb), age at symptom onset, delay from onset to diagnosis and the use of riluzole and non-invasive ventilation (NIV). Clinicians and patients would benefit from a practical way of using these factors to provide an individualised prognosis. 575 consecutive patients with incident ALS from a population-based registry in South-East England register for ALS (SEALS) were studied. Their survival was modelled as a two-step process: the time from diagnosis to respiratory muscle involvement, followed by the time from respiratory involvement to death. The effects of predictor variables were assessed separately for each time interval. Younger age at symptom onset, longer delay from onset to diagnosis and riluzole use were associated with slower progression to respiratory involvement, and NIV use was associated with lower mortality after respiratory involvement, each with a clinically significant effect size. Riluzole may have a greater effect in younger patients and those with longer delay to diagnosis. A patient's survival time has a roughly 50% chance of falling between half and twice the predicted median. A simple and clinically applicable graphical method of predicting an individual patient's survival from diagnosis is presented. The model should be validated in an independent cohort, and extended to include other important prognostic factors. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  8. Prediction of Canopy Heights over a Large Region Using Heterogeneous Lidar Datasets: Efficacy and Challenges

    Directory of Open Access Journals (Sweden)

    Ranjith Gopalakrishnan

    2015-08-01

    Full Text Available Generating accurate and unbiased wall-to-wall canopy height maps from airborne lidar data for large regions is useful to forest scientists and natural resource managers. However, mapping large areas often involves using lidar data from different projects, with varying acquisition parameters. In this work, we address the important question of whether one can accurately model canopy heights over large areas of the Southeastern US using a very heterogeneous dataset of small-footprint, discrete-return airborne lidar data (with 76 separate lidar projects. A unique aspect of this effort is the use of nationally uniform and extensive field data (~1800 forested plots from the Forest Inventory and Analysis (FIA program of the US Forest Service. Preliminary results are quite promising: Over all lidar projects, we observe a good correlation between the 85th percentile of lidar heights and field-measured height (r = 0.85. We construct a linear regression model to predict subplot-level dominant tree heights from distributional lidar metrics (R2 = 0.74, RMSE = 3.0 m, n = 1755. We also identify and quantify the importance of several factors (like heterogeneity of vegetation, point density, the predominance of hardwoods or softwoods, the average height of the forest stand, slope of the plot, and average scan angle of lidar acquisition that influence the efficacy of predicting canopy heights from lidar data. For example, a subset of plots (coefficient of variation of vegetation heights <0.2 significantly reduces the RMSE of our model from 3.0–2.4 m (~20% reduction. We conclude that when all these elements are factored into consideration, combining data from disparate lidar projects does not preclude robust estimation of canopy heights.

  9. Safety and clinical efficacy of tenvermectin, a novel antiparasitic 16-membered macrocyclic lactone antibiotics.

    Science.gov (United States)

    Fei, Chenzhong; She, Rufeng; Li, Guiyu; Zhang, Lifang; Fan, Wushun; Xia, Suhan; Xue, Feiqun

    2018-05-30

    Tenvermectin (TVM) is a novel 16-membered macrocyclic lactone antibiotics, which contains component TVM A and TVM B. However there is not any report on safety and clinical efficacy of TVM for developing as a potential drug. In order to understand the part of safety and clinical efficacy of TVM, we conducted the acute toxicity test, the standard bacterial reverse mutation (Ames) test and the clinical deworming test. In the acute toxicity studies, TVM, TVM A and ivermectin (IVM) were administrated once by oral gavage to mice and rats. Results showed that the oral LD 50 values of TVM, TVM A and IVM in mice were 74.41, 106.95 and 53.06 mg/kg respectively. The oral LD 50 values of TVM and TVM A in rats were determined to be 164.22 and 749.34 mg/kg respectively. TVM and IVM are moderately toxic substances, meanwhile the TVM A belongs to low toxic compounds, implying that the acute toxicity is highly related to the length of side chain of TVM at position C25. In the Ames test, results showed that TVM did not induce mutagenicity in Salmonella typhimurium TA97a, TA98, TA100, TA102 and TA1535 with and without metabolic activation system, speculating that the mutagenicity is probably not related to the side chain at position C25 of 16-membered macrocyclic lactone antibiotics. In the efficacy trail of TVM against swine nematodes, growing pigs natural infection of Ascaris suum and Trichuris suis were treated with a single subcutaneous injection 0.3 mg/kg b.w.. Results showed that TVM and IVM had excellent effect in expelling Ascaris suum, and TVM had potential efficacy against Trichuris suis, however IVM had no effect on Trichuris suis. This study suggests that the side chain of TVM at position C25 may have important biological functions, which is one of the key sites of the studies on structure-activity relationship of 16-membered macrocyclic lactone compounds. TVM is a new compound exhibited some advantages worthy of developing. Copyright © 2018 Elsevier B.V. All

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

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    Maier Anca

    2016-11-01

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

  11. An Exploration of the Needling Depth in Acupuncture: The Safe Needling Depth and the Needling Depth of Clinical Efficacy

    Directory of Open Access Journals (Sweden)

    Jaung-Geng Lin

    2013-01-01

    Full Text Available Objective. To explore the existing scientific information regarding safe needling depth of acupuncture points and the needling depth of clinical efficacy. Methods. We searched the PubMed, EMBASE, Cochrane, Allied and Complementary Medicine (AMED, The National Center for Complementary and Alternative Medicine (NCCAM, and China National Knowledge Infrastructure (CNKI databases to identify relevant monographs and related references from 1991 to 2013. Chinese journals and theses/dissertations were hand searched. Results. 47 studies were recruited and divided into 6 groups by measuring tools, that is, MRI, in vivo evaluation, CT, ultrasound, dissected specimen of cadavers, and another group with clinical efficacy. Each research was analyzed for study design, definition of safe depth, and factors that would affect the measured depths. Depths of clinical efficacy were discussed from the perspective of de-qi and other clinical observations. Conclusions. Great inconsistency in depth of each point measured from different subject groups and tools exists. The definition of safe depth should be established through standardization. There is also lack of researches to compare the clinical efficacy. A well-designed clinical trial selecting proper measuring tools to decide the actual and advisable needling depth for each point, to avoid adverse effects or complications and promote optimal clinical efficacy, is a top priority.

  12. Strategies to design clinical studies to identify predictive biomarkers in cancer research.

    Science.gov (United States)

    Perez-Gracia, Jose Luis; Sanmamed, Miguel F; Bosch, Ana; Patiño-Garcia, Ana; Schalper, Kurt A; Segura, Victor; Bellmunt, Joaquim; Tabernero, Josep; Sweeney, Christopher J; Choueiri, Toni K; Martín, Miguel; Fusco, Juan Pablo; Rodriguez-Ruiz, Maria Esperanza; Calvo, Alfonso; Prior, Celia; Paz-Ares, Luis; Pio, Ruben; Gonzalez-Billalabeitia, Enrique; Gonzalez Hernandez, Alvaro; Páez, David; Piulats, Jose María; Gurpide, Alfonso; Andueza, Mapi; de Velasco, Guillermo; Pazo, Roberto; Grande, Enrique; Nicolas, Pilar; Abad-Santos, Francisco; Garcia-Donas, Jesus; Castellano, Daniel; Pajares, María J; Suarez, Cristina; Colomer, Ramon; Montuenga, Luis M; Melero, Ignacio

    2017-02-01

    The discovery of reliable biomarkers to predict efficacy and toxicity of anticancer drugs remains one of the key challenges in cancer research. Despite its relevance, no efficient study designs to identify promising candidate biomarkers have been established. This has led to the proliferation of a myriad of exploratory studies using dissimilar strategies, most of which fail to identify any promising targets and are seldom validated. The lack of a proper methodology also determines that many anti-cancer drugs are developed below their potential, due to failure to identify predictive biomarkers. While some drugs will be systematically administered to many patients who will not benefit from them, leading to unnecessary toxicities and costs, others will never reach registration due to our inability to identify the specific patient population in which they are active. Despite these drawbacks, a limited number of outstanding predictive biomarkers have been successfully identified and validated, and have changed the standard practice of oncology. In this manuscript, a multidisciplinary panel reviews how those key biomarkers were identified and, based on those experiences, proposes a methodological framework-the DESIGN guidelines-to standardize the clinical design of biomarker identification studies and to develop future research in this pivotal field. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  13. The periodontal abscess (II). Short-term clinical and microbiological efficacy of 2 systemic antibiotic regimes.

    Science.gov (United States)

    Herrera, D; Roldán, S; O'Connor, A; Sanz, M

    2000-06-01

    The aim of this short-term open parallel longitudinal clinical study was to compare the clinical and microbiological efficacy of 2 different antibiotic regimes in the treatment of acute periodontal abscesses. After patient selection, a clinical examination was carried out recording the following variables: pain, edema, redness, swelling, bleeding on probing, suppuration, tooth mobility, lymphadenopathy, and probing pocket depth. Microbiological samples were taken from the lesion and the patient was randomly assigned to one of two antibiotic regimes: azithromycin or amoxicillin/clavulanate. Clinical variables were recorded, and microbiological samples were taken, at 3-5 days, 10-12 days and 30 days. Additional mechanical treatment (debridement and scaling) was performed in the third visit (10-12 days). Blood and urine samples were collected at baseline and after 10-12 days. Microbiological samples were processed by anaerobic culturing, and isolated periodontal pathogens were tested for antibiotic susceptibility by means of the spiral gradient endpoint methodology. 15 patients took azithromycin, and 14 amoxicillin/clavulanate. Subjective clinical variables demonstrated statistically significant improvements with both antibiotic regimes, which lasted for at least 1 month (pperiodontal abscesses in periodontitis patients.

  14. Safety, efficacy, predictability and stability of laser in situ keratomileusis (LASIK) with a 1000-Hz scanning spot excimer laser.

    Science.gov (United States)

    Khoramnia, Ramin; Salgado, Josefina P; Wuellner, Christian; Donitzky, Christof; Lohmann, Chris P; Winkler von Mohrenfels, Christoph

    2012-09-01

    To evaluate the safety, efficacy, predictability and stability of laser in situ keratomileusis (LASIK) with a 1000-Hz scanning spot excimer laser (Concept System 1000; WaveLight GmbH, Erlangen, Germany). LASIK was performed on twenty eyes with myopia or myopic astigmatism (mean spherical equivalent refraction: -3.97±1.72 dioptres (D); mean cylinder: -0.84±0.77 D) using a microkeratome for flap creation and the Concept System 1000 for photoablation. Patients were examined preoperatively as well as 1, 3 and 6 months after the treatment. Manifest sphere and cylinder, uncorrected (UCDVA) and best corrected (BCDVA) distance visual acuity, corneal topography and pachymetry were analysed. We observed no adverse events that might have been associated with the use of a repetition rate of 1000 Hz. All eyes maintained or had improved BCDVA at 6 months after treatment when compared to preoperative values. Six months after LASIK, UCDVA was 20/20 or better in 85% and 20/25 or better in 100% of the eyes. The spherical equivalent refraction was within ±0.50 D in 95% of the eyes at 6 months after surgery. The refraction stayed stable over time; 95% of the eyes changedLASIK with the prototype 1000-Hz excimer laser was safe, efficient and predictable. The postoperative refraction was stable over time. There were no specific clinical side-effects that might be associated with the use of such a high repetition rate. © 2011 The Authors. Acta Ophthalmologica © 2011 Acta Ophthalmologica Scandinavica Foundation.

  15. The Efficacy of Self-Report Measures in Predicting Social Phobia in African American Adults.

    Science.gov (United States)

    Chapman, L Kevin; Petrie, Jenny M; Richards, Allyn

    2015-03-01

    Empirical literature pertaining to anxiety in African Americans has been relatively sparse. More recent studies indicate that the construct of social fear is different in African Americans than in non-Hispanic Whites. Although some of these studies have examined factor structure utilizing self-report measures of anxiety in African American samples, none to date have examined the clinical utility of these measures in predicting anxiety diagnoses, particularly social phobia. A total of sixty-five African American adults from the community completed the Fear Survey Schedule-Second Edition (FSS-II), Social Anxiety Interaction Scale (SIAS), Social Phobia Scale (SPS), and Albany Panic and Phobia Questionnaire (APPQ). The Anxiety Disorder Interview Schedule-Fourth Edition (ADIS-IV) was administered to all participants to specify differential diagnoses of anxiety and related disorders. Twenty-three African American adults were diagnosed with social phobia leaving 42 diagnostic controls. Results suggest that the social anxiety factors were highly predictive of a social phobia diagnosis (AUC=.84 to .90; CI .73-.98, p<.01) and sensitivity and specificity rates revealed optimal cutoff scores for each measure. The optimal cutoff scores reveal the clinical utility of the social fear factor from these measures in screening for social phobia in African Americans. Future direction and implications are discussed. Psychinfo, PubMed, Medline. © 2015 National Medical Association. Published by Elsevier Inc. All rights reserved.

  16. Randomized clinical trial to comparing efficacy of daily, weekly and monthly administration of vitamin D3.

    Science.gov (United States)

    Takács, István; Tóth, Béla E; Szekeres, László; Szabó, Boglárka; Bakos, Bence; Lakatos, Péter

    2017-01-01

    The comparative efficacy and safety profiles of selected daily 1000 IU, weekly 7000 IU and monthly 30,000 IU vitamin D 3 -not previously investigated-will be evaluated. Here, a prospective, randomized clinical trial, comparing efficacy and safety of a daily single dose of 1000 IU (group A) to a once-weekly 7000 IU dose (group B), or monthly 30,000 IU dose (group C) of vitamin D 3 . The present study is a controlled, randomized, open-label, multicenter clinical trial, 3  months in duration. Sixty-four adult subjects with vitamin D deficiency (25OHD<20 ng/ml), were included according to the inclusion and exclusion criteria. Dose-responses for increases in serum vitamin 25OHD were statistically equivalent for each of the three groups: A, B and C. Outcomes were 13.0 ± 1.5; 12.6 ± 1.1 and 12.9 ± 0.9 ng/ml increases in serum 25OHD per 1000 IU, daily, weekly and monthly, respectively. The treatment of subjects with selected doses restored 25OHD values to levels above 20 ng/ml in all groups. Treatment with distinct administration frequency of vitamin D 3 did not exhibit any differences in safety parameters. The daily, weekly and monthly administrations of daily equivalent of 1000 IU of vitamin D 3 provide equal efficacy and safety profiles.

  17. Clinical efficacy, safety, and tolerability of fingolimod for the treatment of relapsing-remitting multiple sclerosis

    Directory of Open Access Journals (Sweden)

    Gajofatto A

    2015-12-01

    Full Text Available Alberto Gajofatto,1,2 Marco Turatti,2 Salvatore Monaco,1,2 Maria Donata Benedetti2 1Department of Neurological, Biomedical and Movement Sciences, University of Verona, Verona, Italy; 2Division of Neurology B, Verona University Hospital, Verona, Italy Abstract: Fingolimod is a selective immunosuppressive agent approved worldwide for the treatment of relapsing-remitting multiple sclerosis (MS, a chronic and potentially disabling neurological condition. Randomized double-blind clinical trials have shown that fingolimod significantly reduces relapse rate and ameliorates a number of brain MRI measures, including cerebral atrophy, compared to both placebo and intramuscular interferon-1a. The effect on disability progression remains controversial, since one Phase III trial showed a significant benefit of treatment while two others did not. Although fingolimod has a very convenient daily oral dosing, the possibility of serious cardiac, ocular, infectious, and other rare adverse events justified the decision of the European Medicines Agency to approve the drug as a second-line treatment for MS patients not responsive to first-line therapy, or those with rapidly evolving course. In the United States, fingolimod is instead authorized as a first-line treatment. The aim of this review is to describe and discuss the characteristics of fingolimod concerning its efficacy, safety, and tolerability in the clinical context of multiple sclerosis management. Keywords: multiple sclerosis, fingolimod, safety, tolerability, efficacy

  18. Safety and clinical efficacy of some radiation-sterilized medical products and pharmaceuticals

    International Nuclear Information System (INIS)

    Kulkarni, R.D.; Gopal, N.G.S.

    1975-01-01

    Medical products and pharmaceuticals must conform to certain minimum physico-chemical microbiological and biological requirements. The biological requirements comprise principally testing for toxicity, safety, and pyrogens. Besides the above-mentioned criteria, there are two other important characteristics, viz. clinical efficacy and tolerance in animal and/or human beings. These latter requirements, expected from the final product released for general human use, are not carried out routinely. In the present-day pharmaceutical and medical technology, numerous mew products are appearing, many of them requiring radiation sterilization as they are not stable towards the other conventional methods of sterilization. While the post-irradiation physicochemical changes in a product may not be significant, the bio-availability or biological activity of the product may be affected to a more significant extent. Some evidence of this has recently been reported. Hence, it is desirable to carry out studies on safety as well as clinical efficacy on irradiated products. This paper describes some studies on plastic-based medical products, a pharmaceutical raw material, a typical infusion fluid such as normal saline, antibiotics and their ointments. (author)

  19. Observation of clinical efficacy of pattern scan laser photocoagulation on diabetic retinopathy

    Directory of Open Access Journals (Sweden)

    Zhi-Hua Peng

    2013-08-01

    Full Text Available AIM: To evaluate the clinical efficacy of pattern scan laser photocoagulation(Pascalon proliferative diabetic retinopathy(PDR.METHODS: A total of 93 patients with retinopathy(186 eyeswere randomly divided into treatment group(96 eyes of 48 patientswho treated with panretinal photocoagulation(PRPusing Pascal at one time and control group(90 eyes of 45 patientswho treated with PRP using multi-wavelength krypton laser in 4-5 times. The visual acuity, FFA, OCT, visual field will be evaluated of each patient before and after the treatment.RESULTS: The visual acuity findings were stated as below: the overall effective rate of visual acuity in treatment group is 85.4% while it is 82.2% in control group. The overall effective rate in two groups has no significant difference. The retinal sensitivity has no significant decrease in the treatment group while which decreased significantly in the control group.CONCLUSION: The clinical efficacy of Pascal on treating the PDR is better than which of the regular argon laser. The field of vision has no significant narrowed after the Pascal treatment which can efficiently shorten the length of treatment and reduce the pain sensation.

  20. Randomized controlled clinical trial on the efficacy of fosfomycin trometamol for uncomplicated gonococcal urethritis in men.

    Science.gov (United States)

    Yuan, Z; He, C; Yan, S; Ke, Y; Tang, W

    2016-06-01

    We assessed the efficacy of fosfomycin trometamol in treating uncomplicated gonococcal urethritis in men. We conducted an open randomized controlled trial in 152 consecutive men with any main complaints suggestive of uncomplicated gonococcal urethritis in Dujiangyan Medical Center between 1 September 2013 and 31 August 2015. In total, 126 patients completed all aspects of this study. Sixty were provided therapy with fosfomycin trometamol 3 g orally on days 1, 3 and 5 in the intervention group; the other 61 were provided ceftriaxone 250 mg intramuscularly plus azithromycin 1 g orally simultaneously as a single dose in the control group. The primary outcomes involved clinical and microbiologic cure on days 7 and 14 after receipt of all the study medications. At the day 7 follow-up visit, all the 121 participants had complete resolution of clinical symptoms and signs. In addition, five patients (two in the intervention group and three in the control group) discontinued intervention because of unsuccessful treatment. After receipt of all the study medications, these five patients still had urethral purulent discharge and were switched to other unknown treatment regimens by other doctors. The bacterial smears and cultures of urethral or urine specimens in the 121 patients who completed all aspects of the study were negative on a test-of-cure visit. In the per-protocol analysis, both clinical and microbiologic cure were experienced by 96.8% (60/62 patients) in the intervention group and 95.3% (61/64 patients) in the control group. There were no recurrences at the day 14 test-of-cure visit. This trial indicates that fosfomycin trometamol exhibits excellent efficacy for treatment of uncomplicated gonococcal urethritis in men. Serious adverse effects are rare. Copyright © 2016 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  1. The Recombinant Bacille Calmette–Guérin Vaccine VPM1002: Ready for Clinical Efficacy Testing

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    Natalie E. Nieuwenhuizen

    2017-09-01

    Full Text Available The only licensed vaccine against tuberculosis (TB, bacille Calmette–Guérin (BCG, protects against severe extrapulmonary forms of TB but is virtually ineffective against the most prevalent form of the disease, pulmonary TB. BCG was genetically modified at the Max Planck Institute for Infection Biology to improve its immunogenicity by replacing the urease C encoding gene with the listeriolysin encoding gene from Listeria monocytogenes. Listeriolysin perturbates the phagosomal membrane at acidic pH. Urease C is involved in neutralization of the phagosome harboring BCG. Its depletion allows for rapid phagosome acidification and promotes phagolysosome fusion. As a result, BCGΔureC::hly (VPM1002 promotes apoptosis and autophagy and facilitates release of mycobacterial antigens into the cytosol. In preclinical studies, VPM1002 has been far more efficacious and safer than BCG. The vaccine was licensed to Vakzine Projekt Management and later sublicensed to the Serum Institute of India Pvt. Ltd., the largest vaccine producer in the world. The vaccine has passed phase I clinical trials in Germany and South Africa, demonstrating its safety and immunogenicity in young adults. It was also successfully tested in a phase IIa randomized clinical trial in healthy South African newborns and is currently undergoing a phase IIb study in HIV exposed and unexposed newborns. A phase II/III clinical trial will commence in India in 2017 to assess efficacy against recurrence of TB. The target indications for VPM1002 are newborn immunization to prevent TB as well as post-exposure immunization in adults to prevent TB recurrence. In addition, a Phase I trial in non-muscle invasive bladder cancer patients has been completed, and phase II trials are ongoing. This review describes the development of VPM1002 from the drawing board to its clinical assessment.

  2. Two-year efficacy of tocilizumab in patients with active rheumatoid arthritis in clinical practice.

    Science.gov (United States)

    Notario Ferreira, Irene; Ferrer González, Miguel Angel; Morales Garrido, Pilar; González Utrilla, Alfonso; García Sanchez, Antonio; Soto Pino, María José; Suero Rosario, Evelyn; Caro Hernández, Cristina; Añón Oñate, Isabel; Pérez Albaladejo, Lorena; Cáliz Cáliz, Rafael

    To evaluate the efficacy of tocilizumab (TCZ) in patients with rheumatoid arthritis (RA) in clinical practice, retention rates of the drug and predictors of response. We performed a descriptive, prospective, longitudinal, open-label study in patients receiving TCZ (8mg/kg/4 weeks) in a clinical practice setting. The clinical responses were evaluated using the European League Against Rheumatism (EULAR) response criteria, and the low activity and remission rates according to the Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR) and the Clinical Disease Activity Index (CDAI). The EULAR response rate was 86.63% and the DAS28 remission rate was 53.7% after 6 months of treatment; rates of low disease activity were 52.9% on CDAI and 47.1% on DAS28 at month 24. There were no statistically significant differences in EULAR response, rates of low activity and remission on DAS28 between patients receiving TCZ alone and those receiving TCZ in combination therapy, or between patients positive or negative for rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide (anti-CCP) antibodies. The naïve biological therapy patients showed better remission and low activity rates after 6 months of treatment. The retention rate was 61% at month 24. Adverse events were among the most frequent causes of discontinuation. Tocilizumab is effective in RA, has a similar efficacy when used alone or in combination with synthetic disease-modifying antirheumatic drugs (DMARDs) and shows high retention rates. Copyright © 2016 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.

  3. Methylphenidate dose optimization for ADHD treatment: review of safety, efficacy, and clinical necessity

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    Huss M

    2017-07-01

    Full Text Available Michael Huss,1 Praveen Duhan,2 Preetam Gandhi,3 Chien-Wei Chen,4 Carsten Spannhuth,3 Vinod Kumar5 1Child and Adolescent Psychiatry, University Medicine, Mainz, Germany; 2Global Medical Affairs, Novartis Healthcare Pvt. Ltd., Hyderabad, India; 3Development Franchise, Established Medicine Neuroscience, Novartis Pharma AG, Basel, Switzerland; 4Biostatistics Cardio-Metabolic & Established Medicine, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA; 5Established Medicines, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA Abstract: Attention-deficit/hyperactivity disorder (ADHD is a chronic psychiatric disorder characterized by hyperactivity and/or inattention and is often associated with a substantial impact on psychosocial functioning. Methylphenidate (MPH, a central nervous system stimulant, is commonly used for pharmacological treatment of adults and children with ADHD. Current practice guidelines recommend optimizing MPH dosage to individual patient needs; however, the clinical benefits of individual dose optimization compared with fixed-dose regimens remain unclear. Here we review the available literature on MPH dose optimization from clinical trials and real-world experience on ADHD management. In addition, we report safety and efficacy data from the largest MPH modified-release long-acting Phase III clinical trial conducted to examine benefits of dose optimization in adults with ADHD. Overall, MPH is an effective ADHD treatment with a good safety profile; data suggest that dose optimization may enhance the safety and efficacy of treatment. Further research is required to establish the extent to which short-term clinical benefits of MPH dose optimization translate into improved long-term outcomes for patients with ADHD. Keywords: methylphenidate, dose optimization, attention-deficit/hyperactivity disorder, ADHD

  4. Improving Clinical Prediction of Bipolar Spectrum Disorders in Youth

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    Thomas W. Frazier

    2014-03-01

    Full Text Available This report evaluates whether classification tree algorithms (CTA may improve the identification of individuals at risk for bipolar spectrum disorders (BPSD. Analyses used the Longitudinal Assessment of Manic Symptoms (LAMS cohort (629 youth, 148 with BPSD and 481 without BPSD. Parent ratings of mania symptoms, stressful life events, parenting stress, and parental history of mania were included as risk factors. Comparable overall accuracy was observed for CTA (75.4% relative to logistic regression (77.6%. However, CTA showed increased sensitivity (0.28 vs. 0.18 at the expense of slightly decreased specificity and positive predictive power. The advantage of CTA algorithms for clinical decision making is demonstrated by the combinations of predictors most useful for altering the probability of BPSD. The 24% sample probability of BPSD was substantially decreased in youth with low screening and baseline parent ratings of mania, negative parental history of mania, and low levels of stressful life events (2%. High screening plus high baseline parent-rated mania nearly doubled the BPSD probability (46%. Future work will benefit from examining additional, powerful predictors, such as alternative data sources (e.g., clinician ratings, neurocognitive test data; these may increase the clinical utility of CTA models further.

  5. Prediction of clinical course of glioblastomas by MRI during radiotherapy

    International Nuclear Information System (INIS)

    Leitzen, Christina; Schild, Hans H.; Bungart, Birgitta; Luetter, Christiana; Muedder, Thomas; Wilhelm-Buchstab, Timo; Schueller, Heinrich; Herrlinger, Ulrich

    2010-01-01

    Purpose: Determine the value of MR studies in patients undergoing radiotherapy for glioblastomas pre and during radiotherapy to predict the clinical course. Patients and Methods: MR follow-up studies were performed in 33 patients with glioblastomas before radiotherapy, after 30 Gy, after 60 Gy, and in the treatment follow-up. Findings on MR were categorized into: definite progress, questionable progress, status idem. Patients were followed clinically (median for 11 months). Results: After 30 Gy 23/33 (70%) of the MR examination showed status idem. 10/33 (30%) demonstrated definite (n = 6) or questionable (n = 4) progress. Further tumor progress was faster in these patients and patients succumb to their disease earlier (9 vs. 22 months). The 60 Gy study showed definite (n = 8) and questionable (n = 6) progress in 14/33 (42%) cases. All these tumors were progressing faster and were associated with a comparatively reduced life expectancy. Conclusion: MR follow-up studies after 30 Gy in patients undergoing radiotherapy for glioblastomas allow for prognostic appraisal, and potentially early modification of treatment. (orig.)

  6. Urate predicts rate of clinical decline in Parkinson disease

    Science.gov (United States)

    Ascherio, Alberto; LeWitt, Peter A.; Xu, Kui; Eberly, Shirley; Watts, Arthur; Matson, Wayne R.; Marras, Connie; Kieburtz, Karl; Rudolph, Alice; Bogdanov, Mikhail B.; Schwid, Steven R.; Tennis, Marsha; Tanner, Caroline M.; Beal, M. Flint; Lang, Anthony E.; Oakes, David; Fahn, Stanley; Shoulson, Ira; Schwarzschild, Michael A.

    2009-01-01

    Context The risk of Parkinson disease (PD) and its rate of progression may decline with increasing blood urate, a major antioxidant. Objective To determine whether serum and cerebrospinal fluid (CSF) concentrations of urate predict clinical progression in patients with PD. Design, Setting, and Participants 800 subjects with early PD enrolled in the DATATOP trial. Pre-treatment urate was measured in serum for 774 subjects and in CSF for 713. Main Outcome Measures Treatment-, age- and sex-adjusted hazard ratios (HRs) for clinical disability requiring levodopa therapy, the pre-specified primary endpoint. Results The HR of progressing to endpoint decreased with increasing serum urate (HR for 1 standard deviation increase = 0.82; 95% CI = 0.73 to 0.93). In analyses stratified by α-tocopherol treatment (2,000 IU/day), a decrease in the HR for the primary endpoint was seen only among subjects not treated with α-tocopherol (HR = 0.75; 95% CI = 0.62 to 0.89, versus those treated HR = 0.90; 95% CI = 0.75 to 1.08). Results were similar for the rate of change in the United Parkinson Disease Rating Scale (UPDRS). CSF urate was also inversely related to both the primary endpoint (HR for highest versus lowest quintile = 0.65; 95% CI: 0.54 to 0.96) and to the rate of change in UPDRS. As with serum urate, these associations were present only among subjects not treated with α-tocopherol. Conclusion Higher serum and CSF urate at baseline were associated with slower rates of clinical decline. The findings strengthen the link between urate and PD and the rationale for considering CNS urate elevation as a potential strategy to slow PD progression. PMID:19822770

  7. Efficacy of the clinical agent VT-1161 against fluconazole-sensitive and -resistant Candida albicans in a murine model of vaginal candidiasis.

    Science.gov (United States)

    Garvey, E P; Hoekstra, W J; Schotzinger, R J; Sobel, J D; Lilly, E A; Fidel, P L

    2015-09-01

    Vulvovaginal candidiasis (VVC) and recurrent VVC (RVVC) remain major health problems for women. VT-1161, a novel fungal CYP51 inhibitor which has potent antifungal activity against fluconazole-sensitive Candida albicans, retained its in vitro potency (MIC50 of ≤0.015 and MIC90 of 0.12 μg/ml) against 10 clinical isolates from VVC or RVVC patients resistant to fluconazole (MIC50 of 8 and MIC90 of 64 μg/ml). VT-1161 pharmacokinetics in mice displayed a high volume of distribution (1.4 liters/kg), high oral absorption (73%), and a long half-life (>48 h) and showed rapid penetration into vaginal tissue. In a murine model of vaginal candidiasis using fluconazole-sensitive yeast, oral doses as low as 4 mg/kg VT-1161 significantly reduced the fungal burden 1 and 4 days posttreatment (P < 0.0001). Similar VT-1161 efficacy was measured when an isolate highly resistant to fluconazole (MIC of 64 μg/ml) but fully sensitive in vitro to VT-1161 was used. When an isolate partially sensitive to VT-1161 (MIC of 0.12 μg/ml) and moderately resistant to fluconazole (MIC of 8 μg/ml) was used, VT-1161 remained efficacious, whereas fluconazole was efficacious on day 1 but did not sustain efficacy 4 days posttreatment. Both agents were inactive in treating an infection with an isolate that demonstrated weaker potency (MICs of 2 and 64 μg/ml for VT-1161 and fluconazole, respectively). Finally, the plasma concentrations of free VT-1161 were predictive of efficacy when in excess of the in vitro MIC values. These data support the clinical development of VT-1161 as a potentially more efficacious treatment for VVC and RVVC. Copyright © 2015, American Society for Microbiology. All Rights Reserved.

  8. Patient-prosthesis mismatch in patients treated with transcatheter aortic valve implantation – predictors, incidence and impact on clinical efficacy. A preliminary study

    Directory of Open Access Journals (Sweden)

    Karol Zbroński

    2017-11-01

    Full Text Available Introduction : Patient-prosthesis mismatch (PPM is relatively frequent after surgical aortic valve replacement (SAVR and negatively impacts prognosis. Aim : We sought to determine the frequency and clinical effects of PPM after transcatheter aortic valve implantation (TAVI. Material and methods : Overall, 238 patients who underwent TAVI were screened. Moderate PPM was defined as indexed effective orifice area (EOAi between 0.65 and 0.85 cm2/m2, and severe PPM as < 0.65 cm2/m2. All-cause mortality and the Valve Academic Research Consortium 2 (VARC-2 defined composite of clinical efficacy at 1 year were the primary endpoints. Results : Finally, 201 patients were included (mean age: 79.6 ±7.4 years, 52% females. The femoral artery served as the delivery route in 79% and most of the prostheses were self-expanding (68%. Any PPM was present in 48 (24% subjects, and only 7 (3.5% had severe PPM. Body surface area (BSA independently predicted any PPM (OR = 16.9, p 20 mm Hg. Conclusions : Severe PPM after TAVI is rare, can be predicted by larger BSA and does not seem to affect mid-term mortality or composite clinical outcome. Larger studies are needed to find different independent predictors of PPM and elucidate its impact in terms of device durability and long-term clinical efficacy.

  9. Therapeutic efficacy of rose oil: A comprehensive review of clinical evidence

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    Safieh Mohebitabar

    2017-04-01

    Full Text Available Objective: Rose oil is obtained from the petals of difference Rosa species especially Rosa centifolia L. and Rosa damascena Mill. Various pharmacological properties have been attributed to rose oil. The aim of the present study was to review the rose oil therapeutic effects which had been clinically evaluated in trial studies. Materials and Methods: Google scholar, PubMed, Cochrane Library, and Scopus were searched for human studies which have evaluated the therapeutic effects of rose oil and published in English language until August 2015. Results: Thirteen clinical trials (772 participants were included in this review. Rose oil was administered via inhalation or used topically. Most of the studies (five trials evaluated the analgesic effect of rose oil. Five studies evaluated the physiological relaxation effect of rose oil. Anti-depressant, psychological relaxation, improving sexual dysfunction, and anti-anxiety effects were the other clinical properties reported for rose oil. Conclusion: Numerous studies on the pharmacological properties of rose oil have been done in animals, but studies in humans are few.  In this study, it was observed that rose oil had physiological and psychological relaxation, analgesic and anti-anxiety effects. To obtain conclusive results on the efficacy and safety of rose oil, further clinical trials with larger sample size and better designation are required.

  10. Is Deqi an Indicator of Clinical Efficacy of Acupuncture? A Systematic Review

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    Shuo Zhang

    2013-01-01

    Full Text Available Objective. Despite the systematic literature review of the current evidence, we aim to answer the question “ is Deqi an indicator of clinical effects in acupuncture treatment?” Methods. We systematically searched CNKI, VIP, Wanfang Data, PubMed, Embase, and the CENTRAL for three types of study: (1 empirical research probing into the role of Deqi in acupuncture; (2 mechanism studies examining the effect of Deqi on physiological parameters in animal models and human subjects; (3 clinical studies that compared the outcome of acupuncture with Deqi with that of acupuncture without Deqi. Two reviewers independently extracted data, undertook qualitative or quantitative analysis, and summarized findings. Results. The ancient Chinese acupuncturists valued the role of Deqi as a diagnostic tool, a prognosis predictor, and a necessary part of the therapeutic procedure. Findings from modern experimental research provided preliminary evidence for the physiological mechanism that produced Deqi. Few clinical studies generated conflicting evidence of the comparative effectiveness of acupuncture with Deqi versus acupuncture without Deqi for a variety of conditions. Conclusion. The current evidence base is not solid enough to draw any conclusion regarding the predicative value of natural Deqi for clinical efficacy or the therapeutic value of manipulation-facilitated Deqi.

  11. Can a physician predict the clinical response to first-line immunomodulatory treatment in relapsing–remitting multiple sclerosis?

    Directory of Open Access Journals (Sweden)

    Mezei Z

    2012-10-01

    Full Text Available Zsolt Mezei,1 Daniel Bereczki,1,2 Lilla Racz,1 Laszlo Csiba,1 Tunde Csepany11Department of Neurology, University of Debrecen, Debrecen, Hungary; 2Department of Neurology, Semmelweis University, Budapest, HungaryBackground: Decreased relapse rate and slower disease progression have been reported with long-term use of immunomodulatory treatments (IMTs, interferon beta or glatiramer acetate in relapsing–remitting multiple sclerosis. There are, however, patients who do not respond to such treatments, and they can be potential candidates for alternative therapeutic approaches.Objective: To identify clinical factors as possible predictors of poor long-term response.Methods: A 9-year prospective, continuous follow-up at a single center in Hungary to assess clinical efficacy of IMT.Results: In a patient group of 81 subjects with mean IMT duration of 54 ± 33 months, treatment efficacy expressed as annual relapse rate and change in clinical severity from baseline did not depend on the specific IMT (any of the interferon betas or glatiramer acetate, and on mono- or multifocal features of the initial appearance of the disease. Responders had shorter disease duration and milder clinical signs at the initiation of treatment. Relapse-rate reduction in the initial 2 years of treatment predicted clinical efficacy in subsequent years.Conclusion: Based on these observations, we suggest that a 2-year trial period is sufficient to decide on the efficacy of a specific IMT. For those with insufficient relapse reduction in the first 2 years of treatment, a different IMT or other therapeutic approaches should be recommended.Keywords: multiple sclerosis, immunomodulatory, EDSS, relapse, response

  12. Child versus family cognitive-behavioral therapy in clinically anxious youth : An efficacy and partial effectiveness study

    NARCIS (Netherlands)

    Bodden, Denise H. M.; Bogels, Susan M.; Nauta, Maaike H.; De Haan, Else; Ringrose, Jaap; Appelboom, Carla; Brinkman, Andries G.; Appelboom-Geerts, Karen C. M. M. J.

    2008-01-01

    Objective: The efficacy and partial effectiveness of child-focused versus family-focused cognitive-behavioral therapy (CBT) for clinically anxious youths was evaluated, in particular in relation to parental anxiety disorders and child's age. Method: Clinically referred children with anxiety

  13. Child Versus Family Cognitive-Behavioral Therapy in Clinically Anxious Youth: An Efficacy and Partial Effectiveness Study

    NARCIS (Netherlands)

    Bodden, D.H.M.; Bögels, S.M.; Nauta, M.H.; Haan, E. de; Ringrose, J.; Appelboom, C.; Brinkman, A.G.; Appelboom-Geerts, K.C.M.M.J.

    2008-01-01

    Objective: The efficacy and partial effectiveness of child-focused versus family-focused cognitive-behavioral therapy (CBT) for clinically anxious youths was evaluated, in particular in relation to parental anxiety disorders and child's age. Method: Clinically referred children with anxiety

  14. Traditional and new composite endpoints in heart failure clinical trials : facilitating comprehensive efficacy assessments and improving trial efficiency

    NARCIS (Netherlands)

    Anker, Stefan D. t; Schroeder, Stefan; Atar, Dan; Bax, Jeroen J.; Ceconi, Claudio; Cowie, Martin R.; AdamCrisp,; Dominjon, Fabienne; Ford, Ian; Ghofrani, Hossein-Ardeschir; Gropper, Savion; Hindricks, Gerhard; Hlatky, Mark A.; Holcomb, Richard; Honarpour, Narimon; Jukema, J. Wouter; Kim, Albert M.; Kunz, Michael; Lefkowitz, Martin; Le Floch, Chantal; Landmesser, Ulf; McDonagh, Theresa A.; McMurray, John J.; Merkely, Bela; Packer, Milton; Prasad, Krishna; Revkin, James; Rosano, Giuseppe M. C.; Somaratne, Ransi; Stough, Wendy Gattis; Voors, Adriaan A.; Ruschitzka, Frank

    Composite endpoints are commonly used as the primary measure of efficacy in heart failure clinical trials to assess the overall treatment effect and to increase the efficiency of trials. Clinical trials still must enrol large numbers of patients to accrue a sufficient number of outcome events and

  15. Measurement of circulating transcripts and gene cluster analysis predicts and defines therapeutic efficacy of peptide receptor radionuclide therapy (PRRT) in neuroendocrine tumors

    International Nuclear Information System (INIS)

    Bodei, L.; Kidd, M.; Modlin, I.M.; Severi, S.; Nicolini, S.; Paganelli, G.; Drozdov, I.; Kwekkeboom, D.J.; Krenning, E.P.; Baum, R.P.

    2016-01-01

    Peptide receptor radionuclide therapy (PRRT) is an effective method for treating neuroendocrine tumors (NETs). It is limited, however, in the prediction of individual tumor response and the precise and early identification of changes in tumor size. Currently, response prediction is based on somatostatin receptor expression and efficacy by morphological imaging and/or chromogranin A (CgA) measurement. The aim of this study was to assess the accuracy of circulating NET transcripts as a measure of PRRT efficacy, and moreover to identify prognostic gene clusters in pretreatment blood that could be interpolated with relevant clinical features in order to define a biological index for the tumor and a predictive quotient for PRRT efficacy. NET patients (n = 54), M: F 37:17, median age 66, bronchial: n = 13, GEP-NET: n = 35, CUP: n = 6 were treated with 177 Lu-based-PRRT (cumulative activity: 6.5-27.8 GBq, median 18.5). At baseline: 47/54 low-grade (G1/G2; bronchial typical/atypical), 31/49 18 FDG positive and 39/54 progressive. Disease status was assessed by RECIST1.1. Transcripts were measured by real-time quantitative reverse transcription PCR (qRT-PCR) and multianalyte algorithmic analysis (NETest); CgA by enzyme-linked immunosorbent assay (ELISA). Gene cluster (GC) derivations: regulatory network, protein:protein interactome analyses. Statistical analyses: chi-square, non-parametric measurements, multiple regression, receiver operating characteristic and Kaplan-Meier survival. The disease control rate was 72 %. Median PFS was not achieved (follow-up: 1-33 months, median: 16). Only grading was associated with response (p < 0.01). At baseline, 94 % of patients were NETest-positive, while CgA was elevated in 59 %. NETest accurately (89 %, χ 2 = 27.4; p = 1.2 x 10 -7 ) correlated with treatment response, while CgA was 24 % accurate. Gene cluster expression (growth-factor signalome and metabolome) had an AUC of 0.74 ± 0.08 (z-statistic = 2.92, p < 0.004) for predicting

  16. Measurement of circulating transcripts and gene cluster analysis predicts and defines therapeutic efficacy of peptide receptor radionuclide therapy (PRRT) in neuroendocrine tumors

    Energy Technology Data Exchange (ETDEWEB)

    Bodei, L. [European Institute of Oncology, Division of Nuclear Medicine, Milan (Italy); LuGenIum Consortium, Milan, Rotterdam, Bad Berka, London, Italy, Netherlands, Germany (Country Unknown); Kidd, M. [Wren Laboratories, Branford, CT (United States); Modlin, I.M. [LuGenIum Consortium, Milan, Rotterdam, Bad Berka, London, Italy, Netherlands, Germany (Country Unknown); Yale School of Medicine, New Haven, CT (United States); Severi, S.; Nicolini, S.; Paganelli, G. [Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Nuclear Medicine and Radiometabolic Units, Meldola (Italy); Drozdov, I. [Bering Limited, London (United Kingdom); Kwekkeboom, D.J.; Krenning, E.P. [LuGenIum Consortium, Milan, Rotterdam, Bad Berka, London, Italy, Netherlands, Germany (Country Unknown); Erasmus Medical Center, Nuclear Medicine Department, Rotterdam (Netherlands); Baum, R.P. [LuGenIum Consortium, Milan, Rotterdam, Bad Berka, London, Italy, Netherlands, Germany (Country Unknown); Zentralklinik Bad Berka, Theranostics Center for Molecular Radiotherapy and Imaging, Bad Berka (Germany)

    2016-05-15

    Peptide receptor radionuclide therapy (PRRT) is an effective method for treating neuroendocrine tumors (NETs). It is limited, however, in the prediction of individual tumor response and the precise and early identification of changes in tumor size. Currently, response prediction is based on somatostatin receptor expression and efficacy by morphological imaging and/or chromogranin A (CgA) measurement. The aim of this study was to assess the accuracy of circulating NET transcripts as a measure of PRRT efficacy, and moreover to identify prognostic gene clusters in pretreatment blood that could be interpolated with relevant clinical features in order to define a biological index for the tumor and a predictive quotient for PRRT efficacy. NET patients (n = 54), M: F 37:17, median age 66, bronchial: n = 13, GEP-NET: n = 35, CUP: n = 6 were treated with {sup 177}Lu-based-PRRT (cumulative activity: 6.5-27.8 GBq, median 18.5). At baseline: 47/54 low-grade (G1/G2; bronchial typical/atypical), 31/49 {sup 18}FDG positive and 39/54 progressive. Disease status was assessed by RECIST1.1. Transcripts were measured by real-time quantitative reverse transcription PCR (qRT-PCR) and multianalyte algorithmic analysis (NETest); CgA by enzyme-linked immunosorbent assay (ELISA). Gene cluster (GC) derivations: regulatory network, protein:protein interactome analyses. Statistical analyses: chi-square, non-parametric measurements, multiple regression, receiver operating characteristic and Kaplan-Meier survival. The disease control rate was 72 %. Median PFS was not achieved (follow-up: 1-33 months, median: 16). Only grading was associated with response (p < 0.01). At baseline, 94 % of patients were NETest-positive, while CgA was elevated in 59 %. NETest accurately (89 %, χ{sup 2} = 27.4; p = 1.2 x 10{sup -7}) correlated with treatment response, while CgA was 24 % accurate. Gene cluster expression (growth-factor signalome and metabolome) had an AUC of 0.74 ± 0.08 (z-statistic = 2.92, p < 0

  17. Clinical utility, safety, and efficacy of pregabalin in the treatment of fibromyalgia

    Directory of Open Access Journals (Sweden)

    Bhusal S

    2016-02-01

    Full Text Available Santosh Bhusal,1 Sherilyn Diomampo,1 Marina N Magrey2 1Division of Rheumatology, Metrohealth Medical Center, 2Case Western Reserve University School of Medicine at Metrohealth Medical Center, Cleveland OH, USA Abstract: Fibromyalgia is a chronic debilitating medical syndrome with limited therapeutic options. Pregabalin, an anticonvulsant and α-2-Δ subunit receptor ligand, is one of the anchor drugs approved by the US Food and Drug Administration for the treatment of fibromyalgia. The drug has shown clinically meaningful benefits across multiple symptom domains of fibromyalgia. Efficacy of pregabalin in fibromyalgia pain has been evaluated in at least five high-quality randomized trials, two long-term extension studies, a meta-analysis, a Cochrane database systematic review, and several post hoc analyses. These studies also hint towards a meaningful benefit on sleep, functioning, quality of life, and work productivity. Side effects of pregabalin, although common, are mild to moderate in intensity. They are noted early during therapy, improve or disappear with dose reduction, and are not usually life- or organ threatening. In most patients, tolerance develops to the most common side effects, dizziness, and somnolence, with time. With close clinical monitoring at initiation or dose titration, pregabalin can be effectively used in primary care setting. Pregabalin is cost saving with long-term use and its cost-effectiveness profile is comparable, if not better, to that of other drugs used in fibromyalgia. In the present era of limited therapeutic options, pregabalin undoubtedly retains its role as one of cardinal drugs used in the treatment of fibromyalgia. This review intends to discuss the clinical utility of pregabalin in the management of fibromyalgia with a focus on efficacy, safety, and cost-effectiveness. Keywords: fibrositis, myofascial pain, diffuse pain syndrome, lyrica

  18. Isavuconazole for the treatment of invasive aspergillosis and mucormycosis: current evidence, safety, efficacy, and clinical recommendations

    Directory of Open Access Journals (Sweden)

    Natesan SK

    2016-12-01

    Full Text Available Suganthini Krishnan Natesan,1,2 Pranatharthi H Chandrasekar1 1Division of Infectious Diseases, Department of Internal Medicine, Wayne State University, 2John D Dingell VA Medical Center, Detroit, MI, USA Abstract: The majority of invasive mold infections diagnosed in immunocompromised cancer patients include invasive aspergillosis (IA and mucormycosis. Despite timely and effective therapy, mortality remains considerable. Antifungal agents currently available for the management of these serious infections include triazoles, polyenes, and echinocandins. Until recently, posaconazole has been the only triazole with a broad spectrum of anti-mold activity against both Aspergillus sp. and mucorales. Other clinically available triazoles voriconazole and itraconazole, with poor activity against mucorales, have significant drug interactions in addition to a side effect profile inherent for all triazoles. Polyenes including lipid formulations pose a problem with infusion-related side effects, electrolyte imbalance, and nephrotoxicity. Echinocandins are ineffective against mucorales and are approved as salvage therapy for refractory IA. Given that all available antifungal agents have limitations, there has been an unmet need for a broad-spectrum anti-mold agent with a favorable profile. Following phase III clinical trials that started in 2006, isavuconazole (ISZ seems to fit this profile. It is the first novel triazole agent recently approved by the United States Food and Drug Administration (FDA for the treatment of both IA and mucormycosis. This review provides a brief overview of the salient features of ISZ, its favorable profile with regard to spectrum of antifungal activity, pharmacokinetic and pharmacodynamic parameters, drug interactions and tolerability, clinical efficacy, and side effects. Keywords: isavuconazole, aspergillosis, mucormycosis, efficacy, antifungal therapy, novel azole, tolerability, drug interactions

  19. Mindfulness predicts student nurses' communication self-efficacy: A cross-national comparative study.

    Science.gov (United States)

    Sundling, Vibeke; Sundler, Annelie J; Holmström, Inger K; Kristensen, Dorte Vesterager; Eide, Hilde

    2017-08-01

    The aim of this study was to compare student nurses' communication self-efficacy, empathy, and mindfulness across two countries, and to analyse the relationship between these qualities. The study had a cross-sectional design. Data was collected from final year student nurses in Norway and Sweden. Communication self-efficacy, empathy, and mindfulness were reported by questionnaires; Clear-cut communication with patients, Jefferson Scale of Empathy, and Langer 14 items mindfulness scale. The study included 156 student nurses, 94 (60%) were Swedish. The mean communication self-efficacy score was 119 (95% CI 116-122), empathy score 115 (95% CI 113-117) and mindfulness score 79 (95% CI 78-81). A Mann-Whitney test showed that Swedish students scored significantly higher on communication self-efficacy, empathy, and mindfulness than Norwegian students did. When adjusted for age, gender, and country in a multiple linear regression, mindfulness was the only independent predictor of communication self-efficacy. The Swedish student nurses in this study scored higher on communication self-efficacy, empathy, and mindfulness than Norwegian students did. Student nurses scoring high on mindfulness rated their communication self-efficacy higher. A mindful learning approach may improve communication self-efficacy and possibly the effect of communication skills training. Copyright © 2017 Elsevier B.V. All rights reserved.

  20. Reading Self-Efficacy Predicts Word Reading But Not Comprehension in Both Girls and Boys.

    Science.gov (United States)

    Carroll, Julia M; Fox, Amy C

    2016-01-01

    The relationship between cognitive skills and reading has been well-established. However, the role of motivational factors such as self-efficacy in reading progress is less clear. In particular, it is not clear how self-efficacy relates to word level reading versus comprehension, and whether this differs in boys and girls. This study examines the relationship between self-efficacy, word reading and reading comprehension across the range of reading abilities after controlling for reading-related cognitive factors. One hundred and seventy nine children (86 males and 93 females) between 8 and 11 years old completed a self-report measure of reading self-efficacy together with measures of reading comprehension and word reading, working memory, auditory short-term memory, phonological awareness, and vocabulary. Boys and girls showed similar levels of attainment and reading self-efficacy. Reading self-efficacy was associated with word reading, but not with reading comprehension in either boys or girls. It is argued that this may reflect important differences between reading self-efficacy and more general measures of reading motivation and engagement. Reading self-efficacy is an element of reading motivation that is closely associated with a child's perceived attainments in reading and is less susceptible to the gender differences seen in broader measures.

  1. Reading Self-Efficacy Predicts Word Reading But Not Comprehension in Both Girls and Boys

    Science.gov (United States)

    Carroll, Julia M.; Fox, Amy C.

    2017-01-01

    The relationship between cognitive skills and reading has been well-established. However, the role of motivational factors such as self-efficacy in reading progress is less clear. In particular, it is not clear how self-efficacy relates to word level reading versus comprehension, and whether this differs in boys and girls. This study examines the relationship between self-efficacy, word reading and reading comprehension across the range of reading abilities after controlling for reading-related cognitive factors. One hundred and seventy nine children (86 males and 93 females) between 8 and 11 years old completed a self-report measure of reading self-efficacy together with measures of reading comprehension and word reading, working memory, auditory short-term memory, phonological awareness, and vocabulary. Boys and girls showed similar levels of attainment and reading self-efficacy. Reading self-efficacy was associated with word reading, but not with reading comprehension in either boys or girls. It is argued that this may reflect important differences between reading self-efficacy and more general measures of reading motivation and engagement. Reading self-efficacy is an element of reading motivation that is closely associated with a child’s perceived attainments in reading and is less susceptible to the gender differences seen in broader measures. PMID:28144223

  2. Morning self-efficacy predicts physical activity throughout the day in knee osteoarthritis.

    Science.gov (United States)

    Zhaoyang, Ruixue; Martire, Lynn M; Sliwinski, Martin J

    2017-06-01

    The purpose of this study was to examine the within-day and cross-day prospective effects of knee osteoarthritis (OA) patients' self-efficacy to engage in physical activity despite the pain on their subsequent physical activity assessed objectively in their natural environment. Over 22 days, 135 older adults with knee OA reported their morning self-efficacy for being physically active throughout the day using a handheld computer and wore an accelerometer to measure moderate activity and steps. Morning self-efficacy had a significant positive effect on steps and moderate-intensity activity throughout that day, above and beyond the effects of demographic background and other psychosocial factors as well as spouses' support and social control. The lagged effect of morning self-efficacy on the next day's physical activity and the reciprocal lagged effect of physical activity on the next day's self-efficacy were not significant. Positive between-person effects of self-efficacy on physical activity were found. Future research should aim to better understand the mechanisms underlying fluctuations in patients' daily self-efficacy, and target patients' daily self-efficacy as a modifiable psychological mechanism for promoting physical activity. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  3. Predicting Physics Achievement: Attitude towards Physics, Self-Efficacy of Learning Physics, and Mathematics Achievement

    Science.gov (United States)

    Kapucu, Serkan

    2017-01-01

    This study aims to explore the relationships among Turkish high school students' attitude towards physics, self-efficacy of learning physics, mathematics achievement, and physics achievement. To investigate the relationships, a unique questionnaire that identifies the attitude, self-efficacy and achievements were delivered to a total of 301 high…

  4. Predicting the efficacy of radiotherapy in individual glioblastoma patients in vivo: a mathematical modeling approach

    International Nuclear Information System (INIS)

    Rockne, R; Alvord, E C Jr; Swanson, K R; Rockhill, J K; Kalet, I; Hendrickson, K; Mrugala, M; Spence, A M; Lai, A; Cloughesy, T

    2010-01-01

    Glioblastoma multiforme (GBM) is the most malignant form of primary brain tumors known as gliomas. They proliferate and invade extensively and yield short life expectancies despite aggressive treatment. Response to treatment is usually measured in terms of the survival of groups of patients treated similarly, but this statistical approach misses the subgroups that may have responded to or may have been injured by treatment. Such statistics offer scant reassurance to individual patients who have suffered through these treatments. Furthermore, current imaging-based treatment response metrics in individual patients ignore patient-specific differences in tumor growth kinetics, which have been shown to vary widely across patients even within the same histological diagnosis and, unfortunately, these metrics have shown only minimal success in predicting patient outcome. We consider nine newly diagnosed GBM patients receiving diagnostic biopsy followed by standard-of-care external beam radiation therapy (XRT). We present and apply a patient-specific, biologically based mathematical model for glioma growth that quantifies response to XRT in individual patients in vivo. The mathematical model uses net rates of proliferation and migration of malignant tumor cells to characterize the tumor's growth and invasion along with the linear-quadratic model for the response to radiation therapy. Using only routinely available pre-treatment MRIs to inform the patient-specific bio-mathematical model simulations, we find that radiation response in these patients, quantified by both clinical and model-generated measures, could have been predicted prior to treatment with high accuracy. Specifically, we find that the net proliferation rate is correlated with the radiation response parameter (r = 0.89, p = 0.0007), resulting in a predictive relationship that is tested with a leave-one-out cross-validation technique. This relationship predicts the tumor size post-therapy to within inter

  5. Clinical efficacy of CT-guided 125I seed implantation therapy for advanced pancreatic cancer

    International Nuclear Information System (INIS)

    Wang Zhongmin; Lu Jian; Gong Ju; Zheng Yunfeng; Zhang Liyun; Huang Gang; Chen Kemin

    2009-01-01

    Objective: To discuss the clinical efficacy of CT-guided radioactive 125 I seed implantation treatment for unresectable pancreatic cancer. Methods: Forty patients with inoperable pancreatic cancer were enrolled in this study, including 25 males and 15 females with an median age of 69 years (38-89 years). Treatment planning system (TPS) was used to reconstruct 3-dimensional images of pancreatic tumor and to define the quantity and distribution of 125 I seeds. The radioactivity of 125 I seeds was 0.5 - 0.8 mCi / seed. The seeds were implanted into pancreatic tumor under CT guidance at intervals of 1 cm and were kept away from vessels, pancreatic duct and other adjacent important organs. The tumor matched peripheral dose (MPD) was 60-140 Gy. The median amount of implanted 125 I seeds was 36 (18-68) in number. CT scan was performed immediately after the procedure to check the quality of the seeds. In addition, 10 patients received concurrent chemotherapy with arterial infusion of gemcitabin and 5-fluororacil (5-Fu) for 3 to 4 therapeutic courses. Results: The median diameter of the tumors was 4.9 cm. The follow-up period was 2 to 28 months. After the treatment the refractory pain was significantly relieved (P 125 I seed implantation is a safe, effective and minimally-invasive brachytherapy for unresectable pancreatic cancer with reliable short-term efficacy. It has an excellent anti-pain effect. The curative results can be further improved when chemotherapy is employed together. However, its long-term efficacy needs to be observed. (authors)

  6. Depressive symptoms, perceived stress, self-efficacy, and outcome expectations: Predict fitness among adolescents with obesity.

    Science.gov (United States)

    Tulloch, Heather; Heenan, Adam; Sweet, Shane; Goldfield, Gary S; Kenny, Glen P; Alberga, Angela S; Sigal, Ronald J

    2017-10-01

    The objective of the present study was to test if outcome expectancy mediated the relationship between fitness and self-efficacy, perceived stress, and depressive symptoms.Adolescents with obesity ( n = 228) completed measures of perceived stress and depressive symptoms at baseline, self-efficacy and outcome expectancy at baseline and 3 months, and fitness at baseline and 6 months. Structural equation modeling was used to analyze the data. Results showed that self-efficacy was positively associated with fitness via outcome expectancies. For females, fewer depressive symptoms were linked to fitness via self-efficacy and outcome expectancies. Exercise interventions that enhance exercise self-efficacy, outcome expectancy, and reduce depressive symptoms may increase fitness.

  7. The Meta-Analysis of Clinical Judgment Project: Fifty-Six Years of Accumulated Research on Clinical Versus Statistical Prediction

    Science.gov (United States)

    Aegisdottir, Stefania; White, Michael J.; Spengler, Paul M.; Maugherman, Alan S.; Anderson, Linda A.; Cook, Robert S.; Nichols, Cassandra N.; Lampropoulos, Georgios K.; Walker, Blain S.; Cohen, Genna; Rush, Jeffrey D.

    2006-01-01

    Clinical predictions made by mental health practitioners are compared with those using statistical approaches. Sixty-seven studies were identified from a comprehensive search of 56 years of research; 92 effect sizes were derived from these studies. The overall effect of clinical versus statistical prediction showed a somewhat greater accuracy for…

  8. Nurse-Administered, Gut-Directed Hypnotherapy in IBS: Efficacy and Factors Predicting a Positive Response.

    Science.gov (United States)

    Lövdahl, Jenny; Ringström, Gisela; Agerforz, Pia; Törnblom, Hans; Simrén, Magnus

    2015-07-01

    Hypnotherapy is an effective treatment in irritable bowel syndrome (IBS). It is often delivered by a psychotherapist and is costly and time consuming. Nurse-administered hypnotherapy could increase availability and reduce costs. In this study the authors evaluate the effectiveness of nurse-administered, gut-directed hypnotherapy and identify factors predicting treatment outcome. Eighty-five patients were included in the study. Participants received hypnotherapy by a nurse once/week for 12 weeks. Patients reported marked improvement in gastrointestinal (GI) and extra-colonic symptoms after treatment, as well as a reduction in GI-specific anxiety, general anxiety, and depression. Fifty-eight percent were responders after the 12 weeks treatment period, and of these 82% had a favorable clinical response already at week 6. Women were more likely than men to respond favorably to the treatment. Nurse-administered hypnotherapy is an effective treatment for IBS. Being female and reporting a favorable response to treatment by week 6 predicted a positive treatment response at the end of the 12 weeks treatment period.

  9. Clinical efficacy of terlipressin in treatment of type II hepatorenal syndrome

    Directory of Open Access Journals (Sweden)

    DING Xiaohong

    2015-05-01

    Full Text Available ObjectiveTo investigate the clinical efficacy of domestic terlipressin in the treatment of type II hepatorenal syndrome (HRS-II. MethodsA total of 25 HRS-II patients admitted to our hospital from November 2011 to June 2014 were recruited into the treatment group, and 28 HRS-II patients treated with dopamine before 2011 were recruited into the control group. Patients in the treatment group were randomly divided into two subgroups: one subgroup (n=12 was given terlipressin once every 8 h, and the other subgroup (n=13 was given terlipressin once every 12 h. Both groups received albumin (Alb infusion to expand the blood volume before treatment with terlipressin or dopamine, and the course of treatment was 7 days. The improvement in clinical symptoms, levels of blood urea nitrogen (BUN, serum creatinine and electrolytes, urine volume, changes in liver function, and ascites disappearance in the two groups before and after treatment were compared. Comparison of categorical data between the two groups was made by χ2 test, and comparison of continuous data was made by t test. ResultsPatients in the control group showed no obvious symptom relief, but those in the treatment group had varying degrees of improvement in clinical symptoms. Neither group had significant changes in liver function and serum sodium level after treatment. The treatment group had significantly more patients whose ascites volume had decreased from large to medium than the control group (χ2=5.705, P<0.05. There was a slight but not significant decrease in the levels of BUN and serum creatinine in the control group after treatment with dopamine (all P>0.05, whereas the urine volume showed significant difference after the treatment (t=15.534, P<0.01. The treatment group showed significant differences in the levels of BUN and serum creatinine and urine volume after terlipressin treatment (t=11.535, 9.941, and 19.685, respectively; all P<0.01, and significant differences in

  10. Clinical efficacy and effectiveness of 3D printing: a systematic review.

    Science.gov (United States)

    Diment, Laura E; Thompson, Mark S; Bergmann, Jeroen H M

    2017-12-21

    To evaluate the clinical efficacy and effectiveness of using 3D printing to develop medical devices across all medical fields. Systematic review compliant with Preferred Reporting Items for Systematic Reviews and Meta-Analyses. PubMed, Web of Science, OVID, IEEE Xplore and Google Scholar. A double-blinded review method was used to select all abstracts up to January 2017 that reported on clinical trials of a three-dimensional (3D)-printed medical device. The studies were ranked according to their level of evidence, divided into medical fields based on the International Classification of Diseases chapter divisions and categorised into whether they were used for preoperative planning, aiding surgery or therapy. The Downs and Black Quality Index critical appraisal tool was used to assess the quality of reporting, external validity, risk of bias, risk of confounding and power of each study. Of the 3084 abstracts screened, 350 studies met the inclusion criteria. Oral and maxillofacial surgery contained 58.3% of studies, and 23.7% covered the musculoskeletal system. Only 21 studies were randomised controlled trials (RCTs), and all fitted within these two fields. The majority of RCTs were 3D-printed anatomical models for preoperative planning and guides for aiding surgery. The main benefits of these devices were decreased surgical operation times and increased surgical accuracy. All medical fields that assessed 3D-printed devices concluded that they were clinically effective. The fields that most rigorously assessed 3D-printed devices were oral and maxillofacial surgery and the musculoskeletal system, both of which concluded that the 3D-printed devices outperformed their conventional comparators. However, the efficacy and effectiveness of 3D-printed devices remain undetermined for the majority of medical fields. 3D-printed devices can play an important role in healthcare, but more rigorous and long-term assessments are needed to determine if 3D-printed devices are

  11. Improved Clinical Efficacy with Wound Support Network Between Hospital and Home Care Service.

    Science.gov (United States)

    Bergersen, Tone Kristin; Storheim, Elisabeth; Gundersen, Stina; Kleven, Linn; Johnson, Maria; Sandvik, Leiv; Kvaerner, Kari Jorunn; Ørjasæter, Nils-Otto

    2016-11-01

    The aim of this study was to test the efficacy of a wound support network model between the primary home care service and the hospital. The impact on wound healing rate, cost benefit, and transfer of knowledge was investigated. The intervention group was exposed to a wound support network (n = 32), and the control group continued standard organization of treatment (n = 21). Nonrandomized controlled study; observations were made before (baseline) and after the implementation of the intervention (12 weeks). Patients with chronic wounds (lasting >6 weeks and with wound area >1 cm) in Oslo, Norway. Closure of the observation wound; wound size; total number of wounds; presence of eczema, edema, and pain; number of dressings per week; time spent per dressing; and number of control appointments at the hospital. The economic impact is calculated for the hospital and for the community of Oslo, Norway. The number of control appointments (t = 3.80, P home care service and the hospital is cost-effective, improves clinical efficacy of the home care services' work, and reduces the need for consultations at the hospital.

  12. The efficacy of trimetazidine on stable angina pectoris: a meta-analysis of randomized clinical trials.

    Science.gov (United States)

    Peng, Song; Zhao, Min; Wan, Jing; Fang, Qi; Fang, Dong; Li, Kaiyong

    2014-12-20

    This meta-analysis aimed to evaluate the efficacy of trimetazidine in combination with other anti-anginal drugs versus other anti-anginal drugs in the treatment of stable angina pectoris (SAP). Randomized controlled trials (RCTs) published in English and Chinese were retrieved from computerized databases: Embase, PubMed, and CNKI. Primary outcomes consist of clinical parameters (numbers of weekly angina attacks and nitroglycerin use) and ergometric parameters (time to 1mm ST-segment depression, and total work (in Mets) and exercise duration (in seconds) at peak exercise) in stable angina pectoris treated by trimetazidine or not. The quality of studies was evaluated using Jadad score. Data analysis of 13 studies was performed using Stata 12.0 software. Results showed that treatment of trimetazidine and other anti-anginal drugs was associated with a smaller weekly mean number of angina attacks (WMD=-0.95, 95%CI: -1.30 to -0.61, Z=5.39, Pangina pectoris. Sensitivity analysis was performed. Sub-group analysis showed that treatment duration was not a significant moderator and patients treated within 8 weeks and above 12 weeks had no difference in the outcomes addressed in this meta-analysis. No publish bias was detected. This meta-analysis confirms the efficacy of trimetazidine in the treatment of stable angina pectoris, in comparison with conventional antianginal agents, regardless of treatment duration. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  13. Predation Efficacy of Bdellovibrio bacteriovorus on Multidrug-Resistant Clinical Pathogens and Their Corresponding Biofilms.

    Science.gov (United States)

    Sun, Yao; Ye, Jianzhong; Hou, Yuanbo; Chen, Huale; Cao, Jianming; Zhou, Tieli

    2017-09-25

    The aim of the present study was to evaluate the predation efficacy of Bdellovibrio bacteriovorus on multidrug-resistant (MDR) or extensive drug resistant (XDR) gram-negative pathogens and their corresponding biofilms. In this study, we examined the ability of B. bacteriovorus to prey on MDR and XDR gram-negative clinical bacteria, including Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Acinetobacter baumannii. Results showed that B. bacteriovorus was able to prey on all planktonic cultures, among which the most efficient predation was observed for drug-resistant E. coli, with a 3.11 log10 reduction in viability. Furthermore, B. bacteriovorus demonstrated promising efficacy in preventing biofilm formation and dispersing the established biofilm. Reductions in biofilm formation of E. coli, K. pneumoniae, P. aeruginosa, and A. baumannii co-cultured with B. bacteriovorus were 65.2%, 37.1%, 44.7%, and 36.8%, respectively. Meanwhile, the established biofilms of E. coli, K. pneumoniae, P. aeruginosa, and A. baumannii were significantly reduced by 83.4%, 81.8%, 83.1%, and 79.9%, respectively. A visual analysis supported by scanning electron microscopy demonstrated the role of B. bacteriovorus in removing the established biofilms. This study highlights the potential use of B. bacteriovorus as a biological control agent with the capability to prey on MDR/XDR gram-negative pathogens and eradicate biofilms.

  14. Efficacy of a probiotic and chlorhexidine mouth rinses: A short-term clinical study

    Directory of Open Access Journals (Sweden)

    Harini P

    2010-09-01

    Full Text Available Introduction: Probiotic technology represents a breakthrough approach to maintaining oral health by utilizing natural beneficial bacteria commonly found in healthy mouths to provide a natural defense against those bacteria thought to be harmful to teeth and gums. However, data are still sparse on the probiotic action in the oral cavity. The review article on probiotics in children published by Twetman and Stecksen- Blicks in 2008 showed only one study of dental interest on probiotics in children. Aim and Objectives: The present study evaluated clinically the efficacy of a probiotic and chlorhexidine mouth rinses on plaque and gingival accumulation in children. The trial design is a double-blind parallel group, 14 days comparative study between a probiotic mouth rinse and a chlorhexidine mouth rinse, which included 45 healthy children in the age group of 6-8 years. Results: The Probiotic and Chlorhexidine groups had less plaque accumulations compared with the Control group at the end of 14 years (P < 0.001 and P < 0.001, respectively. But, unlike the plaque score, there was a significant difference in the Gingival Index between the Probiotic and the Chlorhexidine groups (P = 0.009, Probiotic group being better than the Chlorhexidine group (mean = 0.2300 and 0.6805, respectively. Conclusion: The Probiotic mouth rinse was found effective in reducing plaque accumulation and gingival inflammation. Therefore, probiotic mouth rinse obviously has a potential therapeutic value and further long-term study is recommended to determine its efficacy.

  15. A clinical tool to predict Plasmodium vivax recurrence in Malaysia.

    Science.gov (United States)

    Mat Ariffin, Norliza; Islahudin, Farida; Kumolosasi, Endang; Makmor-Bakry, Mohd

    2017-12-08

    Recurrence rates of Plasmodium vivax infections differ across various geographic regions. Interestingly, South-East Asia and the Asia-Pacific region are documented to exhibit the most frequent recurrence incidences. Identifying patients at a higher risk for recurrences gives valuable information in strengthening the efforts to control P. vivax infections. The aim of the study was to develop a tool to identify P. vivax- infected patients that are at a higher risk of recurrence in Malaysia. Patient data was obtained retrospectively through the Ministry of Health, Malaysia, from 2011 to 2016. Patients with incomplete data were excluded. A total of 2044 clinical P. vivax malaria cases treated with primaquine were included. Data collected were patient, disease, and treatment characteristics. Two-thirds of the cases (n = 1362) were used to develop a clinical risk score, while the remaining third (n = 682) was used for validation. Using multivariate analysis, age (p = 0.03), gametocyte sexual count (p = 0.04), indigenous transmission (p = 0.04), type of treatment (p = 0.12), and incomplete primaquine treatment (p = 0.14) were found to be predictors of recurrence after controlling for other confounding factors; these predictors were then used in developing the final model. The beta-coefficient values were used to develop a clinical scoring tool to predict possible recurrence. The total scores ranged between 0 and 8. A higher score indicated a higher risk for recurrence (odds ratio [OR]: 1.971; 95% confidence interval [CI]: 1.562-2.487; p ≤ 0.001). The area under the receiver operating characteristic (ROC) curve of the developed (n = 1362) and validated model (n = 682) was of good accuracy (ROC: 0.728, 95% CI: 0.670-0.785, p value useful tool in targeting patients at a higher risk for recurrence for closer monitoring during follow-up, after treatment with primaquine.

  16. Can we Predict Disease Course with Clinical Factors?

    Science.gov (United States)

    Vegh, Zsuzsanna; Kurti, Zsuzsanna; Golovics, Petra A; Lakatos, Peter L

    2018-01-01

    The disease phenotype at diagnosis and the disease course of Crohn's disease (CD) and ulcerative colitis (UC) show remarkable heterogeneity across patients. This review aims to summarize the currently available evidence on clinical and some environmental predictive factors, which clinicians should evaluate in the everyday practice together with other laboratory and imaging data to prevent disease progression, enable a more personalized therapy, and avoid negative disease outcomes. In recent population-based epidemiological and referral cohort studies, the evolution of disease phenotype of CD and UC varied significantly. Most CD and severe UC patients still require hospitalization or surgery/colectomy during follow-up. A change in the natural history of inflammatory bowel diseases (IBD) with improved outcomes in parallel with tailored positioning of aggressive immunomodulator and biological therapy has been suspected. According to the currently available literature, it is of major importance to refer IBD cases at risk for adverse disease outcomes as early during the disease course as possible. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  17. Comparison of efficacy, safety, and predictability of laser in situ keratomileusis using two laser suites

    Directory of Open Access Journals (Sweden)

    Meidani A

    2016-08-01

    Full Text Available Alexandra Meidani,1–3 Chara Tzavara3 1Hypervision Laser Centre, 2Eye Day Clinic, 3Department of Hygiene, University of Athens Medical School, Centre for Health Services Research, Epidemiology and Medical Statistics, Athens, Greece Purpose: The main aim of this study was to compare the efficacy, safety, and predictability of femtosecond laser-assisted in situ keratomileusis performed by two different laser suites in the treatment of myopia for up to 6 months.Methods: In this two-site retrospective nonrandomized study, myopic eyes that underwent laser-assisted in situ keratomileusis using IntraLase FS 60 kHz formed group 1 and those using WaveLight FS200 femtosecond laser system formed group 2. Ablation was performed with Visx Star S4 IR and WaveLight EX500 Excimer lasers, respectively, in groups 1 and 2. Both groups were well matched for age, sex, and mean level of preoperative refractive spherical equivalent (MRSE. Uncorrected distance visual acuity, corrected distance visual acuity, and MRSE were evaluated preoperatively and at 1 week, 1 month, and 6 months after treatment.Results: Fifty-six eyes of 28 patients were included in the study. At 6-month follow-up postop, 78.6% of eyes in group 1 and 92.8% of eyes in group 2 achieved an uncorrected distance visual acuity of 20/20 or better (P=0.252. 35.7% and 50% in group 1 and group 2, respectively, gained one line (P=0.179. No eye lost lines of corrected distance visual acuity. Twenty-five eyes in group 1 (92.7% and 27 eyes in group 2 (96.3% had MRSE within ±0.5 D in the 6-month follow-up (P>0.999. The mean efficacy index at 6 months was similar in group 1 and group 2 (mean 1.10±0.12 [standard deviation] vs 1.10±0.1 (P=0.799. The mean safety index was similar in group 1 and group 2 (mean 1.10±0.10 [standard deviation] vs 1.10±0.09 (P=0.407.Conclusion: The outcomes were excellent between the two laser suites. There were no significant differences at 6-month follow-up postop between the two

  18. Clinical efficacy of dexmedetomidine in the diminution of fentanyl dosage in pediatric cardiac surgery.

    Science.gov (United States)

    Sun, Yingying; Ye, Hongwu; Xia, Yin; Li, Yuanhai; Yuan, Xianren; Wang, Xing

    2017-06-01

    This study aims to explore the clinical efficacy of dexmedetomidine (DEX) in the diminution of fentanyl dosage in pediatric cardiac surgery based on some clinical and biochemical parameters. Fifty pediatric patients (American Society of Anesthesiologists II), 1-6 years old, were randomly allocated into two groups: group F (control group), in which patients received normal saline and high dosage of fentanyl (30 μg/kg), and group D, in which patients were given DEX and low dosage of fentanyl (15 μg/kg). Some hemodynamic and clinical parameters of the two groups were recorded. Furthermore, stress hormone (serum cortisol, norepinephrine, blood glucose) levels and cytokine (interleukin 6, tumor necrosis factor alpha) levels in the two groups were compared with each other. Stress hormone levels, cytokine levels, hemodynamic parameters and the consumption of sevoflurane did not differ between the two groups. Meanwhile, the extubation time was significantly shorter in Group D than F (Pfentanyl supplemented with DEX almost had the same anesthesia effects and inflammation extent compared with high dose of fentanyl, which suggested that infusion DEX might decrease fentanyl consumption in pediatric cardiac surgery.

  19. Education as prescription for patients with type 2 diabetes mellitus: compliance and efficacy in clinical practice.

    Science.gov (United States)

    Kim, Mi Yeon; Suh, Sunghwan; Jin, Sang-Man; Kim, Se Won; Bae, Ji Cheol; Hur, Kyu Yeon; Kim, Sung Hye; Rha, Mi Yong; Cho, Young Yun; Lee, Myung-Shik; Lee, Moon Kyu; Kim, Kwang-Won; Kim, Jae Hyeon

    2012-12-01

    Diabetes self-management education has an important role in diabetes management. The efficacy of education has been proven in several randomized trials. However, the status of diabetes education programs in real Korean clinical practice has not yet been evaluated in terms of patient compliance with the education prescription. We retrospectively analyzed clinical and laboratory data from all patients who were ordered to undergo diabetes education during 2009 at Samsung Medical Center, Seoul, Korea (n=2,291). After excluding ineligible subjects, 588 patients were included in the analysis. Among the 588 patients, 433 received education. The overall compliance rate was 73.6%, which was significantly higher in the subjects with a short duration or living in a rural area compared to those with a long duration (85.0% vs. 65.1%, respectively; Ppatients refuse to get education despite having a prescription from their physician. This refusal rate was higher in the patients with long-standing diabetes or in urban residence. Furthermore, education was more effective in patients with a short duration of diabetes in clinical practice.

  20. Epinephrine Improves the Efficacy of Nebulized Hypertonic Saline in Moderate Bronchiolitis: A Randomised Clinical Trial.

    Directory of Open Access Journals (Sweden)

    J Carlos Flores-González

    Full Text Available There is no evidence that the epinephrine-3% hypertonic saline combination is more effective than 3% hypertonic saline alone for treating infants hospitalized with acute bronchiolitis. We evaluated the efficacy of nebulized epinephrine in 3% hypertonic saline.We performed a randomized, double-blind, placebo-controlled clinical trial in 208 infants hospitalized with acute moderate bronchiolitis. Infants were randomly assigned to receive nebulized 3% hypertonic saline with either 3 mL of epinephrine or 3 mL of placebo, administered every four hours. The primary outcome measure was the length of hospital stay.A total of 185 infants were analyzed: 94 in the epinephrine plus 3% hypertonic saline group and 91 in the placebo plus 3% hypertonic saline group. Baseline demographic and clinical characteristics were similar in both groups. Length of hospital stay was significantly reduced in the epinephrine group as compared with the placebo group (3.94 ±1.88 days vs. 4.82 ±2.30 days, P = 0.011. Disease severity also decreased significantly earlier in the epinephrine group (P = 0.029 and P = 0.036 on days 3 and 5, respectively.In our setting, nebulized epinephrine in 3% hypertonic saline significantly shortens hospital stay in hospitalized infants with acute moderate bronchiolitis compared to 3% hypertonic saline alone, and improves the clinical scores of severity from the third day of treatment, but not before.EudraCT 2009-016042-57.

  1. Platelet-Rich Plasma in Bone Regeneration: Engineering the Delivery for Improved Clinical Efficacy

    Directory of Open Access Journals (Sweden)

    Isaac A. Rodriguez

    2014-01-01

    Full Text Available Human bone is a tissue with a fairly remarkable inherent capacity for regeneration; however, this regenerative capacity has its limitations, and defects larger than a critical size lack the ability to spontaneously heal. As such, the development and clinical translation of effective bone regeneration modalities are paramount. One regenerative medicine approach that is beginning to gain momentum in the clinical setting is the use of platelet-rich plasma (PRP. PRP therapy is essentially a method for concentrating platelets and their intrinsic growth factors to stimulate and accelerate a healing response. While PRP has shown some efficacy in both in vitro and in vivo scenarios, to date its use and delivery have not been optimized for bone regeneration. Issues remain with the effective delivery of the platelet-derived growth factors to a localized site of injury, the activation and temporal release of the growth factors, and the rate of growth factor clearance. This review will briefly describe the physiological principles behind PRP use and then discuss how engineering its method of delivery may ultimately impact its ability to successfully translate to widespread clinical use.

  2. Evaluation of clinical efficacy of transrectal sonography and computed tomography for prostatic diseases

    Energy Technology Data Exchange (ETDEWEB)

    Watanabe, Hiroki; Ohe, Hiroshi; Tanahashi, Toshikatsu and others

    1988-07-01

    Receiver operating characteristics (ROC) analysis was performed to evaluate the clinical efficacy of transrectal sonography (US) and computed tomography (CT) for prostatic diseases. One hundred US and CT images of prostatic diseases collected from 10 medical institutions, including 33 cases of prostatic cancer, 29 of benign prostatic hypertrophy, 7 of prostatitis, 2 of prostatic stone and 29 of normal finding, were read by 21 urologists. As the results, US was found to be more useful than CT for both the detection of prostatic diseases and the differentiation between prostatic cancer and benign prostatic hypertrophy. The sensitivity of US for the diagnosis of prostatic cancer was 64.2 % on average of all the urologists. However, the sensitivity was 80.0 % on average of 5 urologists who have read more than 3,000 US images and 59.5 % on average of 16 doctors who have read within 3,000 US images.

  3. Analysis of allergen immunotherapy studies shows increased clinical efficacy in highly symptomatic patients

    DEFF Research Database (Denmark)

    Howarth, P; Malling, Hans-Jørgen; Molimard, M

    2011-01-01

    them. Thus, clinical studies of AIT can neither establish baseline symptom levels nor limit the enrolment of patients to those with the most severe symptoms. Allergen immunotherapy treatment effects are therefore diluted by patients with low symptoms for a particular pollen season. The objective...... tertiles). The difference observed in the average score in each tertile in active vs placebo-treated patients was assessed. This allowed an estimation of the efficacy that could be achieved in patients from sites where symptoms were high during the pollen season. Results:  An increased treatment effect...... of this analysis was to assess the effect possible to achieve with AIT in the groups of patients presenting the most severe allergic symptoms. Methods:  Study centres were grouped into tertiles categorized according to symptom severity scores observed in the placebo patients in each centre (low, middle and high...

  4. Efficacy of panoramic radiography as a screening procedure in dental examination compared with clinical evaluation

    International Nuclear Information System (INIS)

    An, Seo Young; An, Chang Hyeon; Choi, Karp Shik

    2007-01-01

    To evaluate the efficacy of panoramic radiography by comparing the results of clinical examination with radiographic findings. We studied 190 patients (20 men and 170 women; mean age, 40 years; range, 22 to 68 years) who visited the health promotion center of Korea Medical Science Institute and were examined both clinically and by panoramic radiography. We compared results from both examinations. Treatment options by clinical examination were described as 'no treatment indicated', 'treatment of dental caries', 'removal of calculus', 'treatment of periodontal disease'. 'prothodonic treatment' and 'extraction of the third molar'. Findings taken from the panoramic radiography were: dental caries, peroapical lesion, alveolar bone loss, calculus deposition, retained root, impaction of the third molar, disease of maxillary sinus, bony change of mandibular condyle, etc. The prevalence of panoramic findings were: 37.9% of dental caries, 17.4% of periapical lesions, 44.7% of alveolar bone losses, 62.6% of calculi deposition. 7.9% of retained roots, 26.8% of third molar impactions, 6.3% of disease of maxillary sinus, 2.1% of bony changes of mandibular condlye and 35.8% of miscellaneous lesions. Abnormal conditions revealed by panoramic radiography which had not been discovered on clinical examination were: 24.2% of the patients had dental caries, 17.4% had periapical lesions, 7.4% had calculi deposition, 5.3% had retained roots, 15.3% had third molar impactions. The opposite cases were: 5.2% had dental caries, 12.6% had calculi deposition, and 9.5% had third molar impactions. The use of panoramic radiography as a supplement to the clinical examination might be a valuable screening technique

  5. Efficacy of panoramic radiography as a screening procedure in dental examination compared with clinical evaluation

    Energy Technology Data Exchange (ETDEWEB)

    An, Seo Young; An, Chang Hyeon; Choi, Karp Shik [Kyungpook National Univ. School of Dentistry, Daegu (Korea, Republic of)

    2007-06-15

    To evaluate the efficacy of panoramic radiography by comparing the results of clinical examination with radiographic findings. We studied 190 patients (20 men and 170 women; mean age, 40 years; range, 22 to 68 years) who visited the health promotion center of Korea Medical Science Institute and were examined both clinically and by panoramic radiography. We compared results from both examinations. Treatment options by clinical examination were described as 'no treatment indicated', 'treatment of dental caries', 'removal of calculus', 'treatment of periodontal disease'. 'prothodonic treatment' and 'extraction of the third molar'. Findings taken from the panoramic radiography were: dental caries, peroapical lesion, alveolar bone loss, calculus deposition, retained root, impaction of the third molar, disease of maxillary sinus, bony change of mandibular condyle, etc. The prevalence of panoramic findings were: 37.9% of dental caries, 17.4% of periapical lesions, 44.7% of alveolar bone losses, 62.6% of calculi deposition. 7.9% of retained roots, 26.8% of third molar impactions, 6.3% of disease of maxillary sinus, 2.1% of bony changes of mandibular condlye and 35.8% of miscellaneous lesions. Abnormal conditions revealed by panoramic radiography which had not been discovered on clinical examination were: 24.2% of the patients had dental caries, 17.4% had periapical lesions, 7.4% had calculi deposition, 5.3% had retained roots, 15.3% had third molar impactions. The opposite cases were: 5.2% had dental caries, 12.6% had calculi deposition, and 9.5% had third molar impactions. The use of panoramic radiography as a supplement to the clinical examination might be a valuable screening technique.

  6. Timing of delivery in a high-risk obstetric population: a clinical prediction model.

    Science.gov (United States)

    De Silva, Dane A; Lisonkova, Sarka; von Dadelszen, Peter; Synnes, Anne R; Magee, Laura A

    2017-06-29

    The efficacy of antenatal corticosteroid treatment for women with threatened preterm birth depends on timely administration within 7 days before delivery. We modelled the probability of delivery within 7 days of admission to hospital among women presenting with threatened preterm birth, using routinely collected clinical characteristics. Data from the Canadian Perinatal Network (CPN) were used, 2005-11, including women admitted to hospital with preterm labour, preterm pre-labour rupture of membranes, short cervix without contractions, or dilated cervix or prolapsed membranes without contractions at preterm gestation. Women with fetal anomaly, intrauterine fetal demise, twin-to-twin transfusion syndrome, and quadruplets were excluded. Logistic regression was undertaken to create a predictive model that was assessed for its calibration capacity, stratification ability, and classification accuracy (ROC curve). We included 3012 women admitted at 24-28 weeks gestation, or readmitted at up to 34 weeks gestation, to 16 tertiary-care CPN hospitals. Of these, 1473 (48.9%) delivered within 7 days of admission. Significant predictors of early delivery included maternal age, parity, gestational age at admission, smoking, preterm labour, prolapsed membranes, preterm pre-labour rupture of membranes, and antepartum haemorrhage. The area under the ROC curve was 0.724 (95% CI 0.706-0.742). We propose a useful tool to improve prediction of delivery within 7 days after admission among women with threatened preterm birth. This information is important for optimal corticosteroid treatment.

  7. Comparing clinical efficacy of Symbicort versus Pulmicort in reducing asthma symptom and improving its control

    Directory of Open Access Journals (Sweden)

    Mohammad Emami

    2014-01-01

    Full Text Available Background: Recently, higher efficacy of the combination of long-acting beta2-adrenoceptor agonist and inhaled corticosteroids on controlling asthma symptoms has been hypothesized. This study aimed to examine the clinical effects of the combination of Budesonide with formoterol (Symbicort and Budesonide (Pulmicort alone in persistent asthma. Materials and Methods: In a randomized double-blinded clinical trial, 76 patients with definite diagnosis of moderate-to-severe asthma were randomized to receive Pulmicort 180 mcg/inhalation two puffs twice daily, or receive Symbicort 80/4.5 mg/inhalation two puffs twice daily, or receive Symbicort 160/4.5 mg/inhalation two puffs twice daily for 3 months. All participants were initially evaluated by spirometry for assessing respiratory parameters and also the level of asthma control was assessed by Asthma Control Test (ACT. Results: More significant improvement in spirometry parameters, including forced expiratory volume in 1 second (FEV1, forced vital capacity (FVC, FEV1/FVC ratio, as well as in peak expiratory flow (PEF in both groups of Symbicort with the regimens 80/4.5 mg/inhalation or 160/4.5 mg/inhalation 2 puffs twice daily compared with Pulmicort group, ACT score was significantly improved in Symbicort group with the regimens 160/4.5 mg/inhalation compared with both Symbicort groups with lower dosage and Pulmicort group . Response to treatment in PEF parameter and also in ACT level was significantly more in those who received Symbicort with the regimens 160/4.5 mg/inhalation compared with other two interventional groups adjusted for gender and age. Conclusion: Symbicort with the regimens 160/4.5 mg/inhalation has higher efficacy in reducing asthma symptom and improving its control compared with low doses of this drug and with Pulmicort.

  8. A report on the clinical efficacy of a new Bougie-internal urethrectomy.

    Science.gov (United States)

    Hyn, Choe Sung; Jong, Kim Han; Chol, Choe Un

    2015-01-01

    We compare the clinical efficacy of the new bougie-internal urethrectomy (BIU) with internal urethrotomy and urethroplasty to treat urethral stricture disease. We prospectively studied 186 people with urethral stricture disease. Of these, 84 were identified for urethroplasty and 102 for internal urethrotomy (endoscopic urethrotomy). Among the 84 identified for urethroplasty, 52 received BIU (Group 1) and the remaining 32 received urethroplasty. Among the 102 identified for internal urethrotomy, 58 received BIU (Group 2) and the remaining 44 received the internal urethrotomy. After surgery, we evaluated the clinical efficacy of the BIU (operative invasions, voiding flow rates, complications, sequelae) compared with the endoscopic treatment and urethroplasty. Patient age ranged from 20 to 70 years. The follow-up period was 2 years. In the BIU Group 1, the BIU Group 2, and the internal urethrotomy (endoscopic treatment), the length of strictures were 2.9 ± 1.5, 2.8 ± 1.3, 1.6 ± 0.7, and 1.5 ± 0.6, respectively. In the BIU Group 1, the urethroplasty, the BIU Group 2, and the internal urethrotomy (endoscopic treatment), the amount of bleeding was 34.1 ± 17.1, 172.2 ± 29.8, 28.5 ± 9.8, and 49.7 ± 13.6 mL, respectively. In the BIU Group 1, the urethroplasty, the BIU Group 2, and the internal urethrotomy, the recurrence rates were 5.8%, 86%, 6.8% and 25%, and the average flow rates were 18.1 ± 4.8, 13.1 ± 3.9, 18.2 ± 3.6, 10.1 ± 3.1 mL/s, respectively. There was no sequealae (sexual dysfunction, penile change) in both BIU groups. The new BIU could be considered first-line treatment in all patients with indications for visual internal urethrotomy and urethroplasty.

  9. The clinical efficacy evaluation of transcatheter hardening treatment for varicose veins of lower extremity

    International Nuclear Information System (INIS)

    Chen Junhui; Ren Yi; He Ping; Xiong Hongli; Wang Li; Zhou Xianbo

    2007-01-01

    Objective: To explore the clinical efficacy and safety of transcatheter absolute ethanol injection treatment on varicose veins of lower extremity. Methods: twenty-there patients with 25 varicose veins of lower extremity were treated by puncture of great saphenous vein above 1-2 cm of complicated inner ankle, perforating catheter to the point below the 3-4 cm of the conjunction of great saphenous vein and Femoral vein and pressing the conjunction of these two veins. Under the monitor of DSA, inject the absolute ethanol slowly while retrieve the catheter little by little (one limb with varicose veins injected total volume 15-20 mi), in the mean time, using contrast agent to monitor the level of embolism until the formation of total embolism in the all great saphenous veins. Results: All the cases were retrospectively followed up with CDFI examination after 3-12 months of the surgery, No blood flow were seen in the 25 embolismic great saphenous vein. Clinical symptom were alleviated obviously after 2-3 weeks of treatment; varicose veins were collapse after 3 to 7 days. Two cases of leg ulceration were healed after 4 to 6 weeks of operation. 20 limbs were found mild swelling in the 2 day after the surgery. However, all the cases were disappeared after 1 to 2 weeks; 4 treated limbs developed delayed paresthesia in the 3 day after the surgery, and recovered totally in the 2 weeks. No complications of deep vein thrombosis, lung thrombosis etc al, were found after operation. Conclusions: Using transcatheter injection of absolute ethanol to treat varicose veins of lower extremity has the advantage of less invasion, more safety and low appearance of complications. The short term efficacy is solid while the long term effect needs further evaluation. (authors)

  10. Induction of labour: clinical predictive factors for success and failure.

    Science.gov (United States)

    Batinelli, Laura; Serafini, Andrea; Nante, Nicola; Petraglia, Felice; Severi, Filiberto Maria; Messina, Gabriele

    2018-04-01

    literature that 'multiparity' and 'Bishop score' are linked with the success of IOL and adds that 'maternal age' and 'foetal birth weight' are significant risk factors for the population of uncomplicated post term pregnancies induced with prostaglandins. What the implications are of these findings for clinical practice and/or further research: Our results agreed with the existing literature regarding parity and Bishop score but not for maternal age and birth weight. This adds new precious data to the literature which could be used for systematic reviews and for implementing IOL guidelines and protocols, nationally and internationally. Our findings could be also used for guiding future research in this field. It will be interesting to investigate the existence of not just specific factors but also any combination of variables which could predict the success of the procedure. At the moment these information cannot be used in terms of decision making for healthcare professionals as no variable is 100% predictive but once further research will be added, we may be able to know when is best time to start the IOL, how to facilitate the success of the procedure and how to best support the woman throughout the whole experience.

  11. Clinical Evaluation of Efficacy and Performance of All-Poly Tibial Freedom® Total Knee System for Treating Osteoarthritis Patients: Three-Year Follow Up Study.

    Science.gov (United States)

    Singh, Avatar; Singh, Kanwar Kulwinder

    2017-09-01

    Advancement in technology in terms of design and building materials has made Total Knee Replacement (TKR) a highly effective, safe, and predictable orthopedic procedure. To review the clinical outcomes for efficacy and performance of Freedom Total Knee System for the management of Osteoarthritis (OA), at a minimum of three years follow up. For this retrospective, post-marketing study, clinical data of patients treated with Freedom Total Knee System was retrieved from the clinical records after approval from the Institutional Ethics Committee . All the patients above the age of 18 years who completed at least three years after TKR were observed for the study purpose. Patients treated for OA were included while the patients who received the implant for treatment of rheumatoid arthritis and traumatic injury were excluded. Factors such as aseptic loosening, implant failure, and need for revision surgery were observed to evaluate implant performance. Cases were recruited for clinical assessment of primary efficacy endpoint in terms of post-surgery maximun range of motion. Secondary efficacy endpoint was to determine the clinical and social quality of life as per the American Knee Society Score (AKSS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and stiffness scores. A total of 158 patients who had 191 TKR were observed for performance. The mean age of the patients was 67.67 years; mean BMI was 28.97±3.33, and the group comprised of 43% men and 57% women. Telephonic follow up at three years of 158 patients identified that none of them required revision surgery or had aseptic loosening suggesting excellent performance. Final clinical follow up at three years was available for only 35 patients (41 knee implants). The range of motion significantly improved from preoperative 104°±5.67° (range, 85°-119°) to 119.8°±11.05° (98°-123°) at follow-up (ppain, and improved functionality.

  12. Clinical Efficacy and Residue Depletion of 10% Enrofloxacin Enteric-Coated Granules in Pigs.

    Science.gov (United States)

    Lei, Zhixin; Liu, Qianying; Yang, Bing; Xiong, Jincheng; Li, Kun; Ahmed, Saeed; Hong, Liping; Chen, Pin; He, Qigai; Cao, Jiyue

    2017-01-01

    A new, more palatable formulation of 10% enrofloxacin enteric-coated granules was investigated to evaluate the pharmacokinetic effect in plasma, the residue elimination in tissues and the clinical efficacy against Actinobacillus pleuropneumonia (APP) and Mycoplasam suis (MS) in pigs. In this study, the enrofloxacin concentrations in plasma and tissues were detected using high-performance liquid chromatography with phosphate buffer (pH = 3) and acetonitrile. The pharmacokinetics and elimination of enrofloxacin enteric-coated granules were performed after oral administration at a single dose of 10 mg/kg body weight (bw) and 5 mg/kg twice per day for 5 consecutive days, respectively. The in vivo antibacterial efficacy and clinical effectiveness of enrofloxacin enteric-coated granules against APP and MS were assayed at 2.5, 5, 10 mg/kg, compared with tiamulin (8 mg/kg) based on establishment of APP and MS infection models. 56 APP strains were selected and tested for in vitro antibacterial activity of enrofloxacin enteric-coated granules. The main parameters of elimination half-life (t 1/2β ), T max , and area under the curve (AUC) were 14.99 ± 4.19, 3.99 ± 0.10, and 38.93 ± 1.52 μg h/ml, respectively, revealing that the enrofloxacin concentration remained high and with a sustainable distribution in plasma. Moreover, the analysis on the evaluation of enrofloxacin and ciprofloxacin in muscle, fat, liver and kidney showed that the recovery were more than 84% recovery in accordance with the veterinary drug residue guidelines of United States pharmacopeia, and the withdrawal periods were 4.28, 3.81, 4.84, and 3.51 days, respectively, suggesting that the withdrawal period was 5 d after oral administration of 5 mg/kg twice per day. The optimal dosage of enrofloxacin enteric-coated granules against APP and MS was 5 mg/kg, with over 90% efficacy, which was significantly different ( p enrofloxacin enteric-coated granules had significant potential for treating APP and MS

  13. A novel and well tolerated mite allergoid subcutaneous immunotherapy: evidence of clinical and immunologic efficacy

    Science.gov (United States)

    Roger, Albert; Depreux, Nathalie; Jurgens, Yani; Heath, Matthew D; Garcia, Gloria; Skinner, Murray A

    2014-01-01

    Allergy to house dust mite is one of the most common causes of allergic rhinitis. A novel tyrosine-adsorbed, modified allergen product, Acarovac Plus, developed for the treatment of perennial mite allergy seeks to address the underlying cause of allergic rhinitis in this instance. One of two dosing regimens may be used, either the Conventional Regimen or the Cluster Regimen. We sought to compare the efficacy and safety of a specific immunotherapy, developed for the treatment of perennial mite allergy, administered under a Conventional and Clustered dosing schedule in patients with persistent allergic rhinitis. Thirty adult patients, between 18 and 65 years old, with allergic rhinitis and/or asthma secondary to hypersensitivity to Dermatophagoides pteronyssinus were administered with either conventional or cluster initial regime, with a final visit one week after the last dose administration. The efficacy to the Conventional and Cluster regimens was measured using a Nasal Challenge Test monitoring clinical symptoms and peak nasal inspiratory flow. Total IgE, serum-specific inmunoglobulins (IgE and IgG4) to Dermatophagoides pteronyssinus and relevant cytokines (IFN-γ, IL-4, IL-5, IL-10 and IL-13) were assessed. A Satisfaction Questionnaire (TSQM) was completed after each patient's final visit. The tolerability of the vaccine was assessed monitoring adverse reactions. No adverse events were recorded in either conventional or cluster regime. The specific Nasal Challenge Test led to a decrease in symptom scores and a significant decrease in mean nasal peak inspiratory flow drop was recorded in both dosing regimen groups. A significant increase in IgG4-specific antibody titres was assessed. No significant changes were observed in concentrations of total IgE, specific IgE or cytokines (IFN-γ, IL-4, IL-5, IL-10 and IL-13). Patients declared themselves most satisfied in relation to “Secondary effects”, with high overall satisfaction in both groups. Cluster and

  14. Clinical Efficacy and Residue Depletion of 10% Enrofloxacin Enteric-Coated Granules in Pigs

    Directory of Open Access Journals (Sweden)

    Zhixin Lei

    2017-05-01

    Full Text Available A new, more palatable formulation of 10% enrofloxacin enteric-coated granules was investigated to evaluate the pharmacokinetic effect in plasma, the residue elimination in tissues and the clinical efficacy against Actinobacillus pleuropneumonia (APP and Mycoplasam suis (MS in pigs. In this study, the enrofloxacin concentrations in plasma and tissues were detected using high-performance liquid chromatography with phosphate buffer (pH = 3 and acetonitrile. The pharmacokinetics and elimination of enrofloxacin enteric-coated granules were performed after oral administration at a single dose of 10 mg/kg body weight (bw and 5 mg/kg twice per day for 5 consecutive days, respectively. The in vivo antibacterial efficacy and clinical effectiveness of enrofloxacin enteric-coated granules against APP and MS were assayed at 2.5, 5, 10 mg/kg, compared with tiamulin (8 mg/kg based on establishment of APP and MS infection models. 56 APP strains were selected and tested for in vitro antibacterial activity of enrofloxacin enteric-coated granules. The main parameters of elimination half-life (t1/2β, Tmax, and area under the curve (AUC were 14.99 ± 4.19, 3.99 ± 0.10, and 38.93 ± 1.52 μg h/ml, respectively, revealing that the enrofloxacin concentration remained high and with a sustainable distribution in plasma. Moreover, the analysis on the evaluation of enrofloxacin and ciprofloxacin in muscle, fat, liver and kidney showed that the recovery were more than 84% recovery in accordance with the veterinary drug residue guidelines of United States pharmacopeia, and the withdrawal periods were 4.28, 3.81, 4.84, and 3.51 days, respectively, suggesting that the withdrawal period was 5 d after oral administration of 5 mg/kg twice per day. The optimal dosage of enrofloxacin enteric-coated granules against APP and MS was 5 mg/kg, with over 90% efficacy, which was significantly different (p < 0.05 to the 2.5 mg/kg group, but not to the 10 mg/kg group or the positive

  15. Using PEGylated magnetic nanoparticles to describe the EPR effect in tumor for predicting therapeutic efficacy of micelle drugs.

    Science.gov (United States)

    Chen, Ling; Zang, Fengchao; Wu, Haoan; Li, Jianzhong; Xie, Jun; Ma, Ming; Gu, Ning; Zhang, Yu

    2018-01-25

    Micelle drugs based on a polymeric platform offer great advantages over liposomal drugs for tumor treatment. Although nearly all of the nanomedicines approved in the clinical use can passively target to the tumor tissues on the basis of an enhanced permeability and retention (EPR) effect, the nanodrugs have shown heterogenous responses in the patients. This phenomenon may be traced back to the EPR effect of tumor, which is extremely variable in the individuals from extensive studies. Nevertheless, there is a lack of experimental data describing the EPR effect and predicting its impact on therapeutic efficacy of nanoagents. Herein, we developed 32 nm magnetic iron oxide nanoparticles (MION) as a T 2 -weighted contrast agent to describe the EPR effect of each tumor by in vivo magnetic resonance imaging (MRI). The MION were synthesized by a thermal decomposition method and modified with DSPE-PEG2000 for biological applications. The PEGylated MION (Fe 3 O 4 @PEG) exhibited high r 2 of 571 mM -1 s -1 and saturation magnetization (M s ) of 94 emu g -1 Fe as well as long stability and favorable biocompatibility through the in vitro studies. The enhancement intensities of the tumor tissue from the MR images were quantitatively measured as TNR (Tumor/Normal tissue signal Ratio) values, which were correlated with the delay of tumor growth after intravenous administration of the PLA-PEG/PTX micelle drug. The results demonstrated that the group with the smallest TNR values (TNR EPR effect in patients for accurate medication guidance of micelle drugs in the future treatment of tumors.

  16. Predictive value of age for coping: the role of self-efficacy, social support satisfaction and perceived stress.

    Science.gov (United States)

    Trouillet, Raphaël; Gana, Kamel; Lourel, Marcel; Fort, Isabelle

    2009-05-01

    The present study was prompted by the lack of agreement on how coping changes with age. We postulate that the effect of age on coping is mediated by coping resources, such as self-efficacy, perceived stress and social support satisfaction. The participants in the study were community dwelling and aged between 22 and 88 years old. Data were collected using the General Self Efficacy Scale, the Social Support Questionnaire, the Perceived Stress Scale, the Geriatric Depression Scale, the Social Readjustment Rating Scale (life-events) and the Way of Coping Checklist. We performed path analyses for two competitive structural models: M1 (age does not directly affect coping processes) and M2 (age directly affects coping processes). Our results supported a modified version of M2. Age was not found to predict either of two coping strategies: problem-focused coping is predicted by self-efficacy and social support satisfaction; emotion-focused coping is predicted by social support satisfaction and perceived stress. Changes in coping over the lifespan reflect the effectiveness with which a person's adaptive processes deal with age-associated changes in self-referred beliefs and environment perception.

  17. Predictive power of task orientation, general self-efficacy and self-determined motivation on fun and boredom

    Directory of Open Access Journals (Sweden)

    Lorena Ruiz-González

    2015-12-01

    Full Text Available Abstract The aim of this study was to test the predictive power of dispositional orientations, general self-efficacy and self-determined motivation on fun and boredom in physical education classes, with a sample of 459 adolescents between 13 and 18 with a mean age of 15 years (SD = 0.88. The adolescents responded to four Likert scales: Perceptions of Success Questionnaire, General Self-Efficacy Scale, Sport Motivation Scale and Intrinsic Satisfaction Questionnaire in Sport. The results showed the structural regression model showed that task orientation and general self-efficacy positively predicted self-determined motivation and this in turn positively predicted more fun and less boredom in physical education classes. Consequently, the promotion of an educational task-oriented environment where learners perceive their progress and make them feel more competent, will allow them to overcome the intrinsically motivated tasks, and therefore they will have more fun. Pedagogical implications for less boredom and more fun in physical education classes are discussed.

  18. Using protection motivation theory to predict condom usage and assess HIV health communication efficacy in Singapore.

    Science.gov (United States)

    Lwin, May O; Stanaland, Andrea J S; Chan, Desmond

    2010-01-01

    The number of individuals infected with HIV/AIDS continues to rise in Asia. Condom use is considered to be the first line of defense against AIDS (UNAIDS, 2006). Using protection motivation theory (Rogers, 1983), this research aims to first understand the factors affecting condom usage intention among homosexual and heterosexual men in Singapore, and then to utilize those findings to assess the efficacy of HIV-directed health communications. We collected survey data from 484 men and analyzed the data using hierarchical regression and structural equation modeling. We found self-efficacy to be a significant predictor for both groups of men, together with perceived severity for homosexuals and response efficacy for heterosexuals. Next, we analyzed HIV-directed condom usage communication materials and found that the use of threat appeal themes is more common than themes promoting self-efficacy. Implications for health communications and policy are discussed.

  19. Predicting of perceived self efficacy in the amount of macronutrients intake in women with metabolic syndrome - 2012.

    Science.gov (United States)

    Mohebi, Siamak; Azadbakht, Leila; Feizi, Avat; Sharifirad, Gholamreza; Hozori, Mohammad

    2014-01-01

    Metabolic syndrome is a collection of metabolic disorders, which can increase the mortality rates from 20% to 80%. One of strategies to control the disease is the attention to the dietary habits. Compliance with proper diet is one of the major challenges in the management of this syndrome. Due to this fact, that the patient is responsible for the adjustment of the daily diet, it is important to identify the factors affecting the adoption of nutritional self-care. Besides, self-efficacy is considered as an important pre-requisite for this behavior because it acts as an independent part of the basic skills. This study was carried out with the purpose of determining the predictive role of perceived self-efficacy on macronutrients intake in women with metabolic syndrome. In this descriptive study with correlational nature in 2012, there were 329 patients with the metabolic syndrome. The patients were covered by Isfahan oil industry medical centers and selected by a systematic method. In order to gather information on perceived self-efficacy, the questionnaires constructed by the researchers were used and the validity and reliability had been confirmed by the calculation of content validity indexand content validity ratio values and the indices of internal consistency and stability of the tool. The 24-h dietary recall questionnaire was also used for 3 days in order to investigate the nutritional behavior. The obtained data from the dietary recall questionnaire were analyzed by the N4 nutritional software. In this study, AMOS software version 16 was used for the structural model fitting by using the generalized least squares method besides the SPSS statistical software version 16. THESE AVERAGES OBTAINED FROM THE RESULTS: 2512.37 kcal energy intake, 70.95 g protein, 420 g carbohydrates and 61.61 g of fat per day. The mean of perceived self-efficacy score was 47.89. The Pearson correlation coefficient was indicated a significant inverse relationship between the perceived

  20. ECG dispersion mapping predicts clinical deterioration, measured by increase in the Simple Clinical Score.

    LENUS (Irish Health Repository)

    Kellett, J

    2012-01-01

    Objective: ECG dispersion mapping (ECG-DM) is a novel technique that reports abnormal ECG microalternations. We report the ability of ECG-DM to predict clinical deterioration of acutely ill medical patients, as measured by an increase in the Simple Clinical Score (SCS) the day after admission to hospital. Methods: 453 acutely ill medical patients (mean age 69.7 +\\/- 14.0 years) had the SCS recorded and ECGDM performed immediately after admission to hospital. Results: 46 patients had an SCS increase 20.8 +\\/- 7.6 hours after admission. Abnormal micro-alternations during left ventricular re-polarization had the highest association with SCS increase (p=0.0005). Logistic regression showed that only nursing home residence and abnormal micro-alternations during re-polarization of the left ventricle were independent predictors of SCS increase with an odds ratio of 2.84 and 3.01, respectively. Conclusion: ECG-DM changes during left ventricular re-polarization are independent predictors of clinical deterioration the day after hospital admission.

  1. An oracle: antituberculosis pharmacokinetics-pharmacodynamics, clinical correlation, and clinical trial simulations to predict the future.

    Science.gov (United States)

    Pasipanodya, Jotam; Gumbo, Tawanda

    2011-01-01

    Antimicrobial pharmacokinetic-pharmacodynamic (PK/PD) science and clinical trial simulations have not been adequately applied to the design of doses and dose schedules of antituberculosis regimens because many researchers are skeptical about their clinical applicability. We compared findings of preclinical PK/PD studies of current first-line antituberculosis drugs to findings from several clinical publications that included microbiologic outcome and pharmacokinetic data or had a dose-scheduling design. Without exception, the antimicrobial PK/PD parameters linked to optimal effect were similar in preclinical models and in tuberculosis patients. Thus, exposure-effect relationships derived in the preclinical models can be used in the design of optimal antituberculosis doses, by incorporating population pharmacokinetics of the drugs and MIC distributions in Monte Carlo simulations. When this has been performed, doses and dose schedules of rifampin, isoniazid, pyrazinamide, and moxifloxacin with the potential to shorten antituberculosis therapy have been identified. In addition, different susceptibility breakpoints than those in current use have been identified. These steps outline a more rational approach than that of current methods for designing regimens and predicting outcome so that both new and older antituberculosis agents can shorten therapy duration.

  2. External validation of a clinical prediction rule to predict full recovery and ongoing moderate/severe disability following acute whiplash injury.

    Science.gov (United States)

    Ritchie, Carrie; Hendrikz, Joan; Jull, Gwendolen; Elliott, James; Sterling, Michele

    2015-04-01

    Retrospective secondary analysis of data. To investigate the external validity of the whiplash clinical prediction rule (CPR). We recently derived a whiplash CPR to consolidate previously established prognostic factors for poor recovery from a whiplash injury and predicted 2 recovery pathways. Prognostic factors for full recovery were being less than 35 years of age and having an initial Neck Disability Index (NDI) score of 32% or less. Prognostic factors for ongoing moderate/severe pain and disability were being 35 years of age or older, having an initial NDI score of 40% or more, and the presence of hyperarousal symptoms. Validation is required to confirm the reproducibility and accuracy of this CPR. Clinician feedback on the usefulness of the CPR is also important to gauge acceptability. A secondary analysis of data from 101 individuals with acute whiplash-associated disorder who had previously participated in either a randomized controlled clinical trial or prospective cohort study was performed using accuracy statistics. Full recovery was defined as NDI score at 6 months of 10% or less, and ongoing moderate/severe pain and disability were defined as an NDI score at 6 months of 30% or greater. In addition, a small sample of physical therapists completed an anonymous survey on the clinical acceptability and usability of the tool. Results The positive predictive value of ongoing moderate/severe pain and disability was 90.9% in the validation cohort, and the positive predictive value of full recovery was 80.0%. Surveyed physical therapists reported that the whiplash CPR was simple, understandable, would be easy to use, and was an acceptable prognostic tool. External validation of the whiplash CPR confirmed the reproducibility and accuracy of this dual-pathway tool for individuals with acute whiplash-associated disorder. Further research is needed to assess prospective validation, the impact of inclusion on practice, and to examine the efficacy of linking treatment

  3. A comparative clinical study of efficacy of microimmuno assay with WIDAL-test in enteric fever in children

    Directory of Open Access Journals (Sweden)

    Gandarajapura Nagaraj Madhu

    2014-01-01

    Full Text Available The diagnosis of typhoid fever in young children is also a dilemma because of its manifestations and typical presentation may not be seen in all cases. Antibodies to Salmonella typhi antigen are developed in the human body, which can be detected as a diagnostic test for the enteric fever. Objective: This study was undertaken to compare the efficacy of WIDAL-test with micro-immunoassay (dot enzyme immunosorbent assay. Method: 40 cases of clinically suspected enteric fever cases were included in this study. Result: In the present study, nearly 92% were positive for micro immunoassay (dot-enzyme immunosorbent assay by Enterocheck-WB kit, 80% were positive for WIDAL and only 15% were culture positive. Immunoassay positive, but WIDAL negative cases were 20%, whereas WIDAL positive and immunoassay negative cases were only 7.5%. The positive predictivity of micro-immunoassay in diagnosing enteric fever is better than WIDAL both in 1st and 2nd week of illness. Micro-immunoassay done in the study was rapid in diagnosing the case. Conclusion: It is concluded from the present study that the micro-immunoassay (Enterocheck-WB is better than WIDAL-test in the diagnosis of enteric fever in children.

  4. Clinical efficacy of puerarin combined with compound ammonium glycyrrhetate S in treatment of alcoholic hepatitis

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    JI Huichun

    2014-10-01

    Full Text Available ObjectiveTo investigate the clinical efficacy of puerarin combined with compound ammonium glycyrrhetate S in the treatment of alcoholic hepatitis. MethodsA total of 92 patients with alcoholic hepatitis who were admitted to our hospital from February 2011 to February 2014 were recruited in this study and randomly divided into two groups. The control group (n=46 was treated with conventional therapy combined with compound ammonium glycyrrhetate S. The test group (n=46 was treated with puerarin in addition to the regimen used in the control group. After 20 days of treatment, the levels of total bilirubin (TBil, alanine aminotransferase (ALT, aspartate aminotransferase (AST, glutamyl transpeptidase (GGT, albumin (Alb, Glasgow alcoholic hepatitis score (GAHS, and abdominal ultrasound were measured and compared with the results before the treatment in both groups. The clinical efficacy and adverse reactions in the two groups were also compared. ResultsAfter the treatment, the GAHSs and levels of TBil, ALT, AST, and GGT in the two groups were all significantly lower than those before the treatment (all P<0.05. In the test group after the treatment, the levels of TBil (20.96±6.85 μmol/L, ALT (33.72±14.18 U/L, and AST (38.69±6.38 U/L were all significantly lower than those in the control group (all P<0.05. The marked response rate, overall response rate, and rate of improvement in abdominal ultrasound in the test group were 63.04%, 93.48%, and 44.44%, respectively, all significantly higher than those in the control group (all P<0.05. There was no significant difference in adverse reactions between the two groups (P>0.05. ConclusionFor patients with alcoholic hepatitis, the combined therapy with puerarin and compound ammonium glycyrrhetate S can improve the treatment outcome and protect the liver function, and it has high safety and holds promise for clinical application.

  5. Systematic review of efficacy of nutraceuticals to alleviate clinical signs of osteoarthritis.

    Science.gov (United States)

    Vandeweerd, J-M; Coisnon, C; Clegg, P; Cambier, C; Pierson, A; Hontoir, F; Saegerman, C; Gustin, P; Buczinski, S

    2012-01-01

    Various treatments of osteoarthritis (OA) have been described, including use of nutraceuticals. To review systematically the literature about the effects of nutraceuticals on clinical signs of pain or abnormal locomotion in horses, dogs, and cats, and to discuss methodological aspects of trials and systematic reviews. A systematic search of controlled trials evaluating the impact of nutraceuticals on OA in horses, dogs, and cats was performed, using Medline, CAB Abstracts, and Google Scholar. Scientific evidence was evaluated by means of criteria proposed by the Food and Drug Administration (FDA), and a scoring system adapted from both the CONsolidated Standards of Reporting Trials (CONSORT) statement and recommendations for assessing trials by the Center of Evidence Based Medicine of Oxford. Twenty-two papers were selected and reviewed, with 5 studies performed in horses, 16 in dogs, and 1 in cats. The strength of evidence was low for all nutraceuticals except for omega-3 fatty acid in dogs. There were limited numbers of rigorous randomized controlled trials and of participants in clinical trials. The evidence of efficacy of nutraceuticals is poor, with the exception of diets supplemented with omega-3 fatty acids in dogs. Greater access to systematic reviews must be part of the objectives of the veterinary science in the future. Their reporting would be improved by internationally agreed-upon criteria for standards and guidelines. Copyright © 2012 by the American College of Veterinary Internal Medicine.

  6. Pharmacokinetics and clinical efficacy of long-term epidural ropivacaine infusion in children

    DEFF Research Database (Denmark)

    Hansen, Tom Giedsing; Ilett, K F; Lim, S I

    2000-01-01

    The clinical efficacy and pharmacokinetics of long-term epidural ropivacaine infusion were investigated in 18 postoperative children aged between 0.3 and 7.3 yr. A lumbar or thoracic epidural catheter was inserted after the anaesthetic induction. Sixty minutes following a bolus dose of ropivacaine...... 1 mg kg-1, 0.2% ropivacaine was infused at a fixed rate of 0.4 mg kg-1 h-1 for a mean of 61.3 h (range 36-96 h). Clinical evaluation comprised hourly recording of pain, sedation, motor block, nausea/vomiting, pruritus-scores, SpO2, pulse and respiratory rates, and recording of non-invasive arterial......) and free (10-56 micrograms litre-1) ropivacaine concentrations were within the range reported to be 'safe' in previous studies in adults. Mean (95% CI) volume of distribution was 3.1 litre kg-1 (2.1-4.2 litre kg-1), total clearance was 8.5 ml kg-1 min-1 (5.8-11.1 ml kg-1 min-1), free clearance was 220 ml...

  7. [Clinical efficacy of mouse nerve growth factor in treatment of occupational hand-arm vibration disease].

    Science.gov (United States)

    Fan, Chunyue; Wang, Yanyan; Zhang, Ying; Lang, Li; Deng, Xiaofeng; Cheng, Ying

    2014-12-01

    To investigate the efficacy of mouse nerve growth factor (mNGF) in treating occupational hand-arm vibration disease (HAVD). Sixty-four patients with HAVD were equally and randomly divided into treatment group and control group. The control group was given Salvia miltiorrhiza Bunge and deproteinized extract of calf blood to improve circulation, and also given methylcobalamin tablets and vitamin B6 for neurotrophic treatment. In addition to the above treatments for the control group, the treatment group was also given 30 µg/d mNGF by intramuscular injection for two courses (4 weeks for each course) with a 15-day interval. Both the treatment group and the control group showed significant improvements in clinical symptoms and signs (hand numbness and pain, and reduced senses of touch, pain, and vibration), cold water loading test (CWLT), and electroneuromyography (ENMG) after treatments (P hand numbness and pain, reduced senses of touch, pain, and vibration, CWLT, and ENMG, so it has better clinical effect and safety in treating HAVD. Early diagnosis and treatment can improve the outcome of patients with HAVD.

  8. Clinical efficacy and safety of limited internal fixation combined with external fixation for Pilon fracture: A systematic review and meta-analysis

    OpenAIRE

    Zhang, Shaobo; Zhang, Yibao; Wang, Shenghong; Zhang, Hua; Liu, Peng; Zhang, Wei; Ma, Jing-Lin; Wang, Jing

    2017-01-01

    Purpose: To compare the clinical efficacy and complications of limited internal fixation combined with external fixation (LIFEF) and open reduction and internal fixation (ORIF) in the treatment of Pilon fracture. Methods: We searched databases including Pubmed, Embase, Web of science, Cochrane Library and China Biology Medicine disc for the studies comparing clinical efficacy and complications of LIFEF and ORIF in the treatment of Pilon fracture. The clinical efficacy was evaluated by the ...

  9. Efficacy of Various Scoring Systems for Predicting the 28-Day Survival Rate among Patients with Acute Exacerbation of Chronic Obstructive Pulmonary Disease Requiring Emergency Intensive Care

    Directory of Open Access Journals (Sweden)

    Zhihong Feng

    2017-01-01

    Full Text Available We aimed to investigate the efficacy of four severity-of-disease scoring systems in predicting the 28-day survival rate among patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD requiring emergency care. Clinical data of patients with AECOPD who required emergency care were recorded over 2 years. APACHE II, SAPS II, SOFA, and MEDS scores were calculated from severity-of-disease indicators recorded at admission and compared between patients who died within 28 days of admission (death group; 46 patients and those who did not (survival group; 336 patients. Compared to the survival group, the death group had a significantly higher GCS score, frequency of comorbidities including hypertension and heart failure, and age (P<0.05 for all. With all four systems, scores of age, gender, renal inadequacy, hypertension, coronary heart disease, heart failure, arrhythmia, anemia, fracture leading to bedridden status, tumor, and the GCS were significantly higher in the death group than the survival group. The prediction efficacy of the APACHE II and SAPS II scores was 88.4%. The survival rates did not differ significantly between APACHE II and SAPS II (P=1.519. Our results may guide triage for early identification of critically ill patients with AECOPD in the emergency department.

  10. Is the Efficacy of Milnacipran in Fibromyalgia Predictable? A Data-Mining Analysis of Baseline and Outcome Variables

    OpenAIRE

    Abtroun, Lilia; Bunouf, Pierre; Gendreau, Roger M.; Vitton, Olivier

    2016-01-01

    Objectives: Minalcipran has been approved for the treatment of fibromyalgia in several countries including Australia. Australian agency considered that the overall efficacy is moderate, although clinically significant, and could be translated into a real and strong improvement in some patients. The determination of the characteristics of patients who could benefit the most from milnacipran (MLN) is the primary objective of this manuscript. Materials and Methods: Data from the 3 pivotal phase ...

  11. Final Results of the Telaprevir Access Program: FibroScan Values Predict Safety and Efficacy in Hepatitis C Patients with Advanced Fibrosis or Cirrhosis.

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    Antonia Lepida

    Full Text Available Liver stiffness determined by transient elastography is correlated with hepatic fibrosis stage and has high accuracy for detecting severe fibrosis and cirrhosis in chronic hepatitis C patients. We evaluated the clinical value of baseline FibroScan values for the prediction of safety and efficacy of telaprevir-based therapy in patients with advanced fibrosis and cirrhosis in the telaprevir Early Access Program HEP3002.1,772 patients with HCV-1 and bridging fibrosis or cirrhosis were treated with telaprevir plus pegylated interferon-α and ribavirin (PR for 12 weeks followed by PR alone, the total treatment duration depending on virological response and previous response type. Liver fibrosis stage was determined either by liver biopsy or by non-invasive markers. 1,282 patients (72% had disease stage assessed by FibroScan; among those 46% were classified as Metavir F3 at baseline and 54% as F4.Overall, 1,139 patients (64% achieved a sustained virological response (SVR by intention-to-treat analysis. Baseline FibroScan values were tested for association with SVR and the occurrence of adverse events. By univariate analysis, higher baseline FibroScan values were predictive of lower sustained virological response rates and treatment-related anemia. By multivariate analysis, FibroScan was no longer statistically significant as an independent predictor, but higher FibroScan values were correlated with the occurrence of infections and serious adverse events.FibroScan has a limited utility as a predictor of safety and efficacy in patients treated with telaprevir-based triple therapy. Nevertheless it can be used in association with other clinical and biological parameters to help determine patients who will benefit from the triple regiments.ClinicalTrials.gov NCT01508286.

  12. Do self-efficacy and depression predict oral impacts on daily performances across time? A 2-yr follow-up of students in Tanzania.

    Science.gov (United States)

    Åstrøm, Anne N; Lie, Stein A; Mbawalla, Hawa

    2016-08-01

    This study aimed to assess the longitudinal validity of the oral impacts on daily performance (OIDP) and to identify psychosocial determinants, in terms of self-efficacy and depressive symptoms, of the OIDP across time. Following conceptual frameworks of oral health, it was hypothesized that sociodemographic, clinical, and psychosocial factors predict oral impacts across time at both population- averaged and person-specific levels. Whether the effects of sociodemographic and clinical factors were accounted for, totally or in part, by psychosocial factors were also investigated. Self administered questionnaires and oral clinical examinations at baseline (2009) and follow-up (2011) were completed by 1,714 and 727 secondary school students, respectively. Generalized equalized equations and a random intercept model were used to account for the dependency in repeated observations. Mean OIDP change scores were negative (worsened) among those who reported worsened self-reported oral health. Psychosocial, clinical, and sociodemographic factors were independently associated with oral impacts at the population-averaged and person-specific levels. Mediation of sociodemographic and clinical variables according to psychosocial variables was not observed. Satisfactory longitudinal evaluative properties of the OIDP, and independent effects of psychosocial factors on oral impacts across time, were confirmed among secondary school students in Tanzania. © 2016 Eur J Oral Sci.

  13. Clinical spectrum of seizures and efficacy of anticonvulsive treatment in children

    International Nuclear Information System (INIS)

    Mahmud, S.; Zman, S.Q.

    2017-01-01

    Objective: To study the clinical spectrum of seizures and efficacy of anticonvulsive treatment in children. Study Design: A descriptive study. Place and Duration of Study: Military Hospital (MH) Rawalpindi from October 2011 to March 2012. Material and Methods: One hundred children of either gender aged 1 month to 12 years presenting with seizures at Military Hospital Rawalpindi were evaluated and consented to participate in the study. All children with a febrile seizures were evaluated. The seizures were classified according to international league against epilepsy guidelines. Antiepileptic treatment regimen was evaluated in terms of number of drugs, correct dosage and efficacy in control of seizures. Results: It was observed that generalized seizures were (58 percent) followed by focal seizures (32 percent) in children. Valproic acid was prescribed in (51 percent) cases. Epilepsy was diagnosed in (56 percent) followed by cerebral palsy (20 percent), post meningoencephalitis sequalae (11 percent), intracranial hemorrhage (7 percent) and leukodystrophies (3 percnet) as underlying cause of seizures. Statistically significant association was seen between age groups and diagnosis (p value=0.001); age groups and types of seizures (p value=0.046); correct dosage of antiepileptics and control of seizures (p value=0.007); compliance to treatment and control of seizures (p value=0.007). Conclusion: Generalized seizures are the commonest form followed by focal seizures. Epilepsy was the common etiology of seizures in all age groups in children. Cerebral palsy was the second leading cause of seizures in children followed by post meningoencephalitis, stroke and leukodystrophies. Valproic acid was the most commonly prescribed antiepileptic. Normal delivery with delayed cry was the major risk factor for cerebral palsy. Prescription of appropriate antiepileptics according to diagnosis in optimum dosage and compliance to treatment affect control of seizures in children. (author)

  14. Clinical efficacy of basic fibroblast growth factor (bFGF) for diabetic ulcer.

    Science.gov (United States)

    UCHI, Hiroshi; IGARASHI, Atsuyuki; URABE, Kazunori; KOGA, Tetsuya; NAKAYAMA, Juichiro; KAWAMORI, Ryuzo; TAMAKI, Kunihiko; HIRAKATA, Hideki; OHURA, Takehiko; FURUE, Masutaka

    2009-01-01

    Basic fibroblast growth factor (bFGF) has been shown to promote wound healing. The present trial evaluated the clinical efficacy of bFGF for diabetic ulcer, a type of refractory skin ulcer, and the dose-response relationship. This was designed as a randomized, double-blind, dose-ranging, placebo-controlled trial. A total of 150 patients with non-ischaemic diabetic ulcers measuring 900 mm2 or less were randomized into a placebo group (n = 51), a 0.001% bFGF group (n = 49) and a 0.01% bFGF group (n = 50), and 148 of these patients received treatment for 8 weeks or less. The efficacy evaluation was carried out on 139 patients who met the protocol in this trial. The primary outcome was the percentage of patients showing 75% or greater reductions in the area of ulcer. The area of ulcer decreased by 75% or more in 57.5% (27/47), 72.3% (34/47), and 82.2% (37/45) in the placebo, 0.001% bFGF and 0.01% bFGF groups, respectively, and differences were significant between the 0.01% bFGF and placebo groups (p = 0.025). The cure rate was 46.8% (22/47), 57.4% (27/47), and 66.7% (30/45) in the placebo, 0.001% bFGF and 0.01% bFGF groups, respectively. The findings obtained in this trial showed wound healing accelerating effects of bFGF on diabetic ulcers.

  15. [Epidemiologic and therapeutic study on gonococcal infections--clinical efficacy of cefetamet pivoxil].

    Science.gov (United States)

    Nishimura, M; Kumamoto, Y; Hirose, T; Hayashi, K; Tsukamoto, T; Gohro, T; Ikegaki, S; Kamito, H; Inoke, T; Henmi, I

    1990-07-01

    We studied the epidemiology of 109 cases of gonococcal infections (105 males with urethritis and 4 females with cervicitis), together with the basic and clinical effects of cefetamet pivoxil in the cases. The peak of age distribution of the male patients was in the younger half of their twenties, and all of the 4 female cases were between 20 and 39 years old. The major source of infections in the males younger than 25 years old was their girl friends or so-called pick-up friends, and that of the males older than 25 years old workers serving at an amusement center, for example, bars and so-called special massage parlor, which accounted for about three fourths of the male cases between 35 and 44 years old. The distribution of the MIC (inoculum size; 10(6) CFU/ml) of Cefetamet against beta-lactamase non penicillinase producing Neisseria gonorrhoeae (non-PPNG) ranged from 0.025 to 0.1 microgram/ml and that against beta-lactamase producing Neisseria gonorrhoeae ranged from 0.025 to 0.05 microgram/ml. The isolation rate of PPNG was 10.2% (9/88). In male patients with gonococcal urethritis, the efficacy rate was 100% on days 3 and 7 for 1,000 mg single dose and 7-day treatment and 500 mg single dose treatment. One of the cases treated with 250 mg single dose therapy was unchanged at 3, but the efficacy rate of the remaining cases was 100% at day 7. Complicated urethritis with C. trachomatis was noticed in 25.7% (5/105) of the male urethritis and in 25.0% (1/4) of the female cervicitis cases. The only side effect was diarrhea observed in 1 of the 124 case (0.8%).

  16. Clinical efficacy, safety and tolerance of the Kerawort (imiquimod cream used for treatment of anogenital warts

    Directory of Open Access Journals (Sweden)

    M. R. Rakhmatulina

    2015-01-01

    Full Text Available Goal of the study. To assess the efficacy and safety of Kerawort (Imiquimod, 5% cream for topical administration vs. placebo used for treatment of anogenital warts. Methods and materials. The single-blind comparative placebo-controlled study involved 90 patients (44 female and 46 male with anogenital warts. The patients were randomized into two groups: the main group (n = 45 receiving treatment with Kerawort (Imiquimod, 5% cream and the control group (n = 45 receiving placebo. The diagnosis was confirmed by the identification of human papillomavirus by the polymerase chain reaction method. The patients received treatment three times a week until clinical signs disappeared but for not more than 16 weeks. Results. In 95.6% of patients from the main group and 8.9% of patients from the control group, anogenital warts disappeared completely or the quantity/area of pathological eruptions reduced at least by 70% as compared to the baseline. No relapses occurred during the treatment and follow-up period (28 days after the completion of treatment in patients from the main group. An increase in the size and/or area of anogenital warts and/or development of new eruptions on the skin and mucous membrane of the genitals were recorded in 11.1% of patients from the control group. No serious adverse events were revealed during the study. Conclusion. Higher efficacy (р < 0.0000001 and comparable safety of Kerawort (Imiquimod, 5% cream for topical administration used for treatment of anogenital warts vs. placebo were reliably established.

  17. Assessment of the clinical efficacy of the heart spectrum blood pressure monitor for diagnosis of atrial fibrillation: An unblinded clinical trial.

    Science.gov (United States)

    Kao, Wei-Fong; Hou, Sen-Kuang; Huang, Chun-Yao; Chao, Chun-Chieh; Cheng, Chung-Chih; Chen, Yi-Jung

    2018-01-01

    Atrial fibrillation (AF) is the most common arrhythmia. The most common diagnostic method, 12-lead electrocardiogram (ECG), can record episodes of arrhythmia from which the type and severity can be determined. The Heart Spectrum Blood Pressure Monitor (P2; OSTAR Meditech Corp., New Taipei City, Taiwan) is used to measure cardiovascular pressure change with fast Fourier transform (FFT) analysis to obtain heart rate frequency variability and accurate blood pressure data. We compared the diagnostic efficacy of the Heart Spectrum Blood Pressure Monitor to a 12-lead ECG (gold standard) for patients with AF. Three measurement methods were used in this study to analyze the heart index and compare the results with simultaneous 12-lead ECG: blood pressure; mean arterial pressure, which was calculated from individual blood pressure as a constant pressure; and a constant pressure of 60 mmHg. The physician used a 12-lead ECG and the Heart Spectrum Blood Pressure Monitor simultaneously. The Heart Spectrum Blood Pressure Monitor used FFT analysis to diagnose AF, and the findings were compared to the 12-lead ECG readings. This unblinded clinical trial was conducted in the emergency department of Taipei Medical University Hospital. Twenty-nine subjects with AF and 33 without AF aged 25 to 97 y (mean, 63.5 y) were included. Subjects who were exposed to high-frequency surgical equipment during testing, those with cardiac pacemakers or implantable defibrillators, and pregnant women were excluded. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were 97%, 97%, 97%, and 97%, respectively, for method 1; 90%, 100%, 100%, and 91%, respectively, for method 2; and 100%, 94%, 94%, and 100%, respectively, for method 3. The sensitivity, specificity, PPV, and NPV for both methods ranged between 90% and 100%, indicating that the Heart Spectrum Blood Pressure Monitor can be effectively applied for AF detection.

  18. Multi-task learning for cross-platform siRNA efficacy prediction: an in-silico study.

    Science.gov (United States)

    Liu, Qi; Xu, Qian; Zheng, Vincent W; Xue, Hong; Cao, Zhiwei; Yang, Qiang

    2010-04-10

    Gene silencing using exogenous small interfering RNAs (siRNAs) is now a widespread molecular tool for gene functional study and new-drug target identification. The key mechanism in this technique is to design efficient siRNAs that incorporated into the RNA-induced silencing complexes (RISC) to bind and interact with the mRNA targets to repress their translations to proteins. Although considerable progress has been made in the computational analysis of siRNA binding efficacy, few joint analysis of different RNAi experiments conducted under different experimental scenarios has been done in research so far, while the joint analysis is an important issue in cross-platform siRNA efficacy prediction. A collective analysis of RNAi mechanisms for different datasets and experimental conditions can often provide new clues on the design of potent siRNAs. An elegant multi-task learning paradigm for cross-platform siRNA efficacy prediction is proposed. Experimental studies were performed on a large dataset of siRNA sequences which encompass several RNAi experiments recently conducted by different research groups. By using our multi-task learning method, the synergy among different experiments is exploited and an efficient multi-task predictor for siRNA efficacy prediction is obtained. The 19 most popular biological features for siRNA according to their jointly importance in multi-task learning were ranked. Furthermore, the hypothesis is validated out that the siRNA binding efficacy on different messenger RNAs(mRNAs) have different conditional distribution, thus the multi-task learning can be conducted by viewing tasks at an "mRNA"-level rather than at the "experiment"-level. Such distribution diversity derived from siRNAs bound to different mRNAs help indicate that the properties of target mRNA have important implications on the siRNA binding efficacy. The knowledge gained from our study provides useful insights on how to analyze various cross-platform RNAi data for uncovering

  19. Multi-task learning for cross-platform siRNA efficacy prediction: an in-silico study

    Directory of Open Access Journals (Sweden)

    Xue Hong

    2010-04-01

    Full Text Available Abstract Background Gene silencing using exogenous small interfering RNAs (siRNAs is now a widespread molecular tool for gene functional study and new-drug target identification. The key mechanism in this technique is to design efficient siRNAs that incorporated into the RNA-induced silencing complexes (RISC to bind and interact with the mRNA targets to repress their translations to proteins. Although considerable progress has been made in the computational analysis of siRNA binding efficacy, few joint analysis of different RNAi experiments conducted under different experimental scenarios has been done in research so far, while the joint analysis is an important issue in cross-platform siRNA efficacy prediction. A collective analysis of RNAi mechanisms for different datasets and experimental conditions can often provide new clues on the design of potent siRNAs. Results An elegant multi-task learning paradigm for cross-platform siRNA efficacy prediction is proposed. Experimental studies were performed on a large dataset of siRNA sequences which encompass several RNAi experiments recently conducted by different research groups. By using our multi-task learning method, the synergy among different experiments is exploited and an efficient multi-task predictor for siRNA efficacy prediction is obtained. The 19 most popular biological features for siRNA according to their jointly importance in multi-task learning were ranked. Furthermore, the hypothesis is validated out that the siRNA binding efficacy on different messenger RNAs(mRNAs have different conditional distribution, thus the multi-task learning can be conducted by viewing tasks at an "mRNA"-level rather than at the "experiment"-level. Such distribution diversity derived from siRNAs bound to different mRNAs help indicate that the properties of target mRNA have important implications on the siRNA binding efficacy. Conclusions The knowledge gained from our study provides useful insights on how to

  20. Clinical, endoscopical and morphological efficacy of mesalazine in patients with irritable bowel syndrome

    Directory of Open Access Journals (Sweden)

    Dorofeyev AE

    2011-06-01

    Full Text Available Andrey E Dorofeyev1, Elena A Kiriyan2, Inna V Vasilenko1, Olga A Rassokhina1, Andrey F Elin11National Medical University, Donetsk, Ukraine; 2Gastroenterological Center of Poltava Hospital Clinic, Poltava, UkraineObjectives: The aim of this study was to analyze the clinical efficacy and cytomorphologic changes of colon mucosa following the treatment of patients suffering from irritable bowel syndrome (IBS with mesalazine (5-aminosalicylic acid [5-ASA].Methods: In this controlled, randomized, blind clinical trial, a total of 360 patients with varying subtypes of IBS were randomly treated with 500 mg of mesalazine qid or by standard therapy without mesalazine for a period of 28 days. Pre- and post-treatment pain intensity, pain duration, meteorism, stool abnormalities and endoscopic parameters were monitored, and biopsies or brush biopsies were examined histologically.Results: Treatment of IBS patients with mesalazine significantly reduced intensity and duration of pain in all subtypes of IBS, except for duration of pain in the subtype “undifferentiated”, where the difference was not significant. In addition, in patients with diarrhea type and undifferentiated type of IBS, mesalazine also significantly reduced the abnormal stool pattern. In comparison to the control group, administration of mesalazine reduced the incidence of endoscopic and cytomorphologic changes of the bowel mucosa, including changes in colon mucus, mucus production, cytologic or histologic parameters, epithelial cell degeneration, appearance of leukocytes and macrophages and cell infiltrations.Conclusion: Mesalazine was effective in reducing several symptoms characteristic of IBS. It significantly reduced pain intensity and duration and improved cytohistologic parameters of the bowel mucosa.Keywords: 5-amino salicylic acid, 5-ASA, abdominal pain, irritable bowel syndrome, IBS, meteorism, stool abnormalities

  1. Education as Prescription for Patients with Type 2 Diabetes Mellitus: Compliance and Efficacy in Clinical Practice

    Directory of Open Access Journals (Sweden)

    Mi Yeon Kim

    2012-12-01

    Full Text Available BackgroundDiabetes self-management education has an important role in diabetes management. The efficacy of education has been proven in several randomized trials. However, the status of diabetes education programs in real Korean clinical practice has not yet been evaluated in terms of patient compliance with the education prescription.MethodsWe retrospectively analyzed clinical and laboratory data from all patients who were ordered to undergo diabetes education during 2009 at Samsung Medical Center, Seoul, Korea (n=2,291. After excluding ineligible subjects, 588 patients were included in the analysis.ResultsAmong the 588 patients, 433 received education. The overall compliance rate was 73.6%, which was significantly higher in the subjects with a short duration or living in a rural area compared to those with a long duration (85.0% vs. 65.1%, respectively; P<0.001 or living in an urban area (78.2% vs. 70.4%, respectively; P=0.037. The hemoglobin A1c decreased greater in the compliant group (from 7.84±1.54 at baseline to 6.79±1.06 at 3 months and 6.97±1.20 at 12 months after prescription in the compliant group vs. from 7.74±1.25 to 7.14±1.02 and 7.24±1.24 in the non-compliant group; P=0.001. The decrease in hemoglobin A1c was greater in the subjects with a short duration (P=0.032.ConclusionIn our study a large percent of patients refuse to get education despite having a prescription from their physician. This refusal rate was higher in the patients with long-standing diabetes or in urban residence. Furthermore, education was more effective in patients with a short duration of diabetes in clinical practice.

  2. Clinical efficacy of Saccharomyces boulardii or metronidazole in symptomatic children with Blastocystis hominis infection.

    Science.gov (United States)

    Dinleyici, Ener Cagri; Eren, Makbule; Dogan, Nihal; Reyhanioglu, Serap; Yargic, Zeynel Abidin; Vandenplas, Yvan

    2011-03-01

    Although many Blastocystis infections remain asymptomatic, recent data suggest it also causes frequent symptoms. Therapy should be limited to patients with persistent symptoms and a complete workup for alternative etiologies. The goal of this study was to compare the natural evolution (no treatment) to the efficacy of Saccharomyces boulardii (S. boulardii) or metronidazole for the duration of diarrhea and the duration of colonization in children with gastrointestinal symptoms and positive stool examination for Blastocystis hominis. This randomized single-blinded clinical trial included children presenting with gastrointestinal symptoms (abdominal pain, diarrhea, nausea-vomiting, flatulence) more than 2 weeks and confirmed B. hominis by stool examination (B. hominis cysts in the stool with microscopic examination of the fresh stool). The primary end points were clinical evaluation and result of microscopic stool examination at day 15. Secondary end points were the same end points at day 30. Randomization was performed by alternating inclusion: group A, S. boulardii (250 mg twice a day, Reflor®) during 10 days; group B, metronidazole (30 mg/kg twice daily) for 10 days; group C, no treatment. At day 15 and 30 after inclusion, the patients were re-evaluated, and stool samples were examined microscopically. On day 15, children that were still symptomatic and/or were still B. hominis-infected in group C were treated with metronidazole for 10 days. There was no statistically significant difference between the three study groups for age, gender, and the presence of diarrhea and abdominal pain. On day 15, clinical cure was observed in 77.7% in group A (n, 18); in 66.6% in group B (n, 15); and 40% in group C (n:15) (p boulardii has potential beneficial effects in B. hominis infection (symptoms, presence of parasites). These findings challenge the actual guidelines.

  3. "In this together": Social identification predicts health outcomes (via self-efficacy) in a chronic disease self-management program.

    Science.gov (United States)

    Cameron, James E; Voth, Jennifer; Jaglal, Susan B; Guilcher, Sara J T; Hawker, Gillian; Salbach, Nancy M

    2018-03-05

    Self-management programs are an established approach to helping people cope with the challenges of chronic disease, but the psychological mechanisms underlying their effectiveness are not fully understood. A key assumption of self-management interventions is that enhancing people's self-efficacy (e.g., via the development of relevant skills and behaviours) encourages adaptive health-related behaviors and improved health outcomes. However, the group-based nature of the programs allows for the possibility that identification with other program members is itself a social psychological platform for positive changes in illness-related confidence (i.e., group-derived efficacy) and physical and mental health. The researchers evaluated this hypothesis in a telehealth version of a chronic disease self-management program delivered in 13 rural and remote communities in northern Ontario, Canada (September 2007 to June 2008). Participants were 213 individuals with a self-reported physician diagnosis of chronic lung disease, heart disease, stroke, or arthritis. Measures of social identification, group-derived efficacy, and individual efficacy were administered seven weeks after baseline, and mental and physical health outcomes (health distress, psychological well-being, depression, vitality, pain, role limits, and disability) were assessed at four months. Structural equation modeling indicated that social identification was a positive predictor of group-derived efficacy and (in turn) individual self-efficacy (controlling for baseline), which was significantly associated with better physical and mental health outcomes. The results are consistent with growing evidence of the value of a social identity-based approach in various health and clinical settings. The success of chronic disease self-management programs could be enhanced by attending to and augmenting group identification during and after the program. Copyright © 2018 Elsevier Ltd. All rights reserved.

  4. Clinical prediction of 5-year survival in systemic sclerosis

    DEFF Research Database (Denmark)

    Fransen, Julie Munk; Popa-Diaconu, D; Hesselstrand, R

    2011-01-01

    Systemic sclerosis (SSc) is associated with a significant reduction in life expectancy. A simple prognostic model to predict 5-year survival in SSc was developed in 1999 in 280 patients, but it has not been validated in other patients. The predictions of a prognostic model are usually less accura...

  5. Efficacy of clinical diagnostic procedures utilized in nuclear medicine. Technical progress report, 1 December 1981-30 November 1982

    International Nuclear Information System (INIS)

    Saenger, E.L.

    1982-07-01

    The efficacy of nuclear medicine diagnostic procedures was measured. Three levels of efficacy were defined. However, two different methods of evaluating efficacy itself were first compared. Using two methods, logistic regression and entropy-minimax pattern detection, substantial agreement was found between them in several clinical observations. (1) There are no attributes that indicate that any grouping of symptoms, signs, and laboratory findings is capable of suggesting that a patient does or does not have a pulmonary embolus. (2) The lung scan test is the only reliable method which indicates that a patient may have a pulmonary embolus or does not have a pulmonary embolus. (3) The validity of these conclusions and the ability to apply them widely to ongoing clinical practice is based on the prospective design of the Study which included an appropriate distribution of institutions by type, size, and geographic location. Also, the only judgement samples was that of the referring physician

  6. The role of attitudes and self-efficacy in predicting condom use and purchase intentions.

    Science.gov (United States)

    Gabler, Joanna; Kropp, Fredric; Silvera, David H; Lavack, Anne M

    2004-01-01

    This study examines the condom purchasing and use habits of 256 college students in Norway and English-speaking Canada, and develops a structural equation model to explain condom purchase and use. In the model, intention to purchase condoms is influenced by self-efficacy in condom purchasing, as well as by intention to use condoms. Intention to use condoms is influenced by having a positive attitude toward condom usage and by self-efficacy in persuading a partner to use condoms. The implications for health promotion and social marketing campaigns are discussed.

  7. Can clinical prediction tools predict the need for computed tomography in blunt abdominal? A systematic review.

    Science.gov (United States)

    Sharples, Alistair; Brohi, Karim

    2016-08-01

    Blunt abdominal trauma is a common reason for admission to the Emergency Department. Early detection of injuries is an important goal but is often not straightforward as physical examination alone is not a good predictor of serious injury. Computed tomography (CT) has become the primary method for assessing the stable trauma patient. It has high sensitivity and specificity but there remains concern regarding the long term consequences of high doses of radiation. Therefore an accurate and reliable method of assessing which patients are at higher risk of injury and hence require a CT would be clinically useful. We perform a systematic review to investigate the use of clinical prediction tools (CPTs) for the identification of abdominal injuries in patients suffering blunt trauma. A literature search was performed using Medline, Embase, The Cochrane Library and NHS Evidence up to August 2014. English language, prospective and retrospective studies were included if they derived, validated or assessed a CPT, aimed at identifying intra-abdominal injuries or the need for intervention to treat an intra-abdominal after blunt trauma. Methodological quality was assessed using a 14 point scale. Performance was assessed predominantly by sensitivity. Seven relevant studies were identified. All studies were derivative studies and no CPT was validated in a separate study. There were large differences in the study design, composition of the CPTs, the outcomes analysed and the methodological quality of the included studies. Sensitivities ranged from 86 to 100%. The highest performing CPT had a lower limit of the 95% CI of 95.8% and was of high methodological quality (11 of 14). Had this rule been applied to the population then 25.1% of patients would have avoided a CT scan. Seven CPTs were identified of varying designs and methodological quality. All demonstrate relatively high sensitivity with some achieving very high sensitivity whilst still managing to reduce the number of CTs

  8. Treg depletion inhibits efficacy of cancer immunotherapy: implications for clinical trials.

    Directory of Open Access Journals (Sweden)

    James F Curtin

    2008-04-01

    Full Text Available Regulatory T lymphocytes (Treg infiltrate human glioblastoma (GBM; are involved in tumor progression and correlate with tumor grade. Transient elimination of Tregs using CD25 depleting antibodies (PC61 has been found to mediate GBM regression in preclinical models of brain tumors. Clinical trials that combine Treg depletion with tumor vaccination are underway to determine whether transient Treg depletion can enhance anti-tumor immune responses and improve long term survival in cancer patients.Using a syngeneic intracrabial glioblastoma (GBM mouse model we show that systemic depletion of Tregs 15 days after tumor implantation using PC61 resulted in a decrease in Tregs present in tumors, draining lymph nodes and spleen and improved long-term survival (50% of mice survived >150 days. No improvement in survival was observed when Tregs were depleted 24 days after tumor implantation, suggesting that tumor burden is an important factor for determining efficacy of Treg depletion in clinical trials. In a T cell dependent model of brain tumor regression elicited by intratumoral delivery of adenoviral vectors (Ad expressing Fms-like Tyrosine Kinase 3 ligand (Flt3L and Herpes Simplex Type 1-Thymidine Kinase (TK with ganciclovir (GCV, we demonstrate that administration of PC61 24 days after tumor implantation (7 days after treatment inhibited T cell dependent tumor regression and long term survival. Further, depletion with PC61 completely inhibited clonal expansion of tumor antigen-specific T lymphocytes in response to the treatment.Our data demonstrate for the first time, that although Treg depletion inhibits the progression/eliminates GBM tumors, its efficacy is dependent on tumor burden. We conclude that this approach will be useful in a setting of minimal residual disease. Further, we also demonstrate that Treg depletion, using PC61 in combination with immunotherapy, inhibits clonal expansion of tumor antigen-specific T cells, suggesting that new, more

  9. Telmisartan in daily clinical practice: Factors affecting efficacy in treatment of primary arterial hypertension

    Directory of Open Access Journals (Sweden)

    Bergovac M

    2009-01-01

    Full Text Available Background: Telmisartan provides effective treatment of hypertension in a broad spectrum of patients. Aims: To evaluate factors affecting the efficacy of telmisartan in daily clinical practice. Setting and Design: Prospective practice-based 12-week uncontrolled cohort study. Materials and Methods: Consecutive incident/prevalent outpatients with mild to moderate essential hypertension were started on telmisartan 40 mg/day with optional up-titration to 80 mg/day in order to achieve seated systolic (SSBP and diastolic (SDBP blood pressure < 140/90 mm Hg. Intent-to-treat (ITT, N=282 and per protocol (PP, N=275 efficacy assessment was based on SSBP/SDBP reduction and delivered doses. Results: SSBP/SDBP decreased (165.2±13.1 / 98.3±6.7 mm Hg to 137.9±13.2 / 82.6±7.3 mm Hg, whilst telmisartan was up-titrated in 40.5% of patients during the study. Multivariate (practically identical ITT and PP analysis indicated poorer response in obese vs. non-obese patients: lesser SDBP reduction (by around 2.2-2.3 mm Hg, P < 0.05 with higher odds of dose up-titration (odds ratio, OR around 1.90, P < 0.05; and better response in: a patients started on telmisartan monotherapy than when added to a preexisting treatment: greater SSBP/SDBP reduction (by around 4.0 and 3.0 mm Hg, respectively, P < 0.05 with comparable odds of up-titration; b diabetics vs. non-diabetics: greater SDBP reduction (by around 3.6-3.7 mm Hg, P < 0.05 with comparable odds of up-titration; c men vs. women: slightly greater SDBP reduction (by around 1.2 mm Hg, 0.05 P < 0.1 with lower odds of up-titration (OR around 0.51, P < 0.05. Conclusion: Previous unsuccessful treatment, obesity, diabetes and gender should be considered in order to optimize the use of telmisartan for mild to moderate essential hypertension in daily clinical practice.

  10. Child versus Family Cognitive-Behavioral Therapy in Clinically Anxious Youth: An Efficacy and Partial Effectiveness Study

    Science.gov (United States)

    Bodden, Denise H. M.; Bogels, Susan M.; Nauta, Maaike H.; De Hann, Else; Ringrose, Jaap; Appelboom, Carla; Brinkman, Andries G.; Appelboom-Geerts, Karen C. M. M. J.

    2008-01-01

    Child-focused and family-focused cognitive-behavioral therapy (CBT) for 128 children with clinical anxiety disorders and their parents were compared in terms of efficacy and partial effectiveness. Results indicate that 53% of the children under the child CBT became free of anxiety disorders at posttreamtent compared to only 28% under family CBT.…

  11. Hyperbaric oxygen therapy for wound healing in diabetic rats: Varying efficacy after a clinically-based protocol

    NARCIS (Netherlands)

    J.W. van Neck (Han); B. Tuk (Bastiaan); E.M.G. Fijneman (Esther ); Redeker, J.J. (Jonathan J.); Talahatu, E.M. (Edwin M.); M. Tong (Miao)

    2017-01-01

    textabstractHyperbaric oxygen therapy (HBOT) is a clinical treatment in which a patient breathes pure oxygen for a limited period of time at an increased pressure. Although this therapy has been used for decades to assist wound healing, its efficacy for many conditions is unproven and its mechanism

  12. Investigations of efficacy of intramammary applied antimicrobials and glucocorticosteroides in the treatment of subclinical and clinical mastitis in cows

    OpenAIRE

    Vakanjac, Slobodanka; Pavlović, Vojislav; Magaš, Vladimir; Pavlović, Miloš; Đurić, Miloje; Maletić, Milan; Nedić, Svetlana; Sočo, Ivan

    2013-01-01

    Inflammation of the mammary gland, mastitis in cows, presents one of the most acute problems in intensive dairy production, inflicting huge economic losses. In the course of one year, 80 samples were taken at investigated farms from udder quarters of cows with clinical mastitis and 160 samples from udder quarters of cows with subclinical mastitis. The efficacy of three preparations, A, B, and C, was examined in the treatment of clinical and subclinical mast...

  13. Internet Self-Efficacy Does Not Predict Student Use of Internet-Mediated Educational Technology

    Science.gov (United States)

    Buchanan, Tom; Joban, Sanjay; Porter, Alan

    2014-01-01

    Two studies tested the hypothesis that use of learning technologies among undergraduate psychology students was associated with higher Internet self-efficacy (ISE). In Study 1, the ISE scores of 86 students were found not to be associated with either attitudes towards, or measured use of, blogs and wikis as part of an IT skills course. ISE was…

  14. The Relationship between Vocational Interests, Self-Efficacy, and Achievement in the Prediction of Educational Pathways

    Science.gov (United States)

    Patrick, Lyn; Care, Esther; Ainley, Mary

    2011-01-01

    The influence of vocational interest, self-efficacy beliefs, and academic achievement on choice of educational pathway is described for a cohort of Australian students. Participants were 189 students aged 14-15 years, who were considering either academic or applied learning pathways and subject choices for the final 3 years of secondary school.…

  15. Preliminary Evidence that Self-Efficacy Predicts Physical Activity in Multiple Sclerosis

    Science.gov (United States)

    Motl, Robert W.; McAuley, Edward; Doerksen, Shawna; Hu, Liang; Morris, Katherine S.

    2009-01-01

    Individuals with multiple sclerosis (MS) are less physically active than nondiseased people. One method for increasing physical activity levels involves the identification of factors that correlate with physical activity and that are modifiable by a well designed intervention. This study examined two types of self-efficacy as cross-sectional and…

  16. Parenting Self-Efficacy Predicts Perceptions of Infant Negative Temperament Characteristics, Not Vice Versa

    NARCIS (Netherlands)

    Verhage, M.L.; Oosterman, M.; Schuengel, C.

    2013-01-01

    Infant temperamental characteristics have been found associated with decreasing parenting self-efficacy(PSE) during the first year after birth, which has been generally interpreted as a child effect on the parent.To test direction of effects, PSE was assessed during the third trimester of pregnancy

  17. Gender Differences in the Importance of Personality Traits in Predicting Leadership Self-Efficacy

    Science.gov (United States)

    Huszczo, Gregory; Endres, Megan Lee

    2017-01-01

    Our goal in this study was to investigate antecedents to formation of leadership self-efficacy (LSE) for men versus women. We used a relative importance analysis, which allows more precise identification of important predictors without concern of multicollinearity effects on R[superscript 2]. Using a sample of 325 business students, we found that…

  18. Clinical predictive factors for endometriosis in a Portuguese infertile population

    NARCIS (Netherlands)

    Calhaz-Jorge, C.; Mol, Ben W.; Nunes, J.; Costa, A. P.

    2004-01-01

    BACKGROUND: Endometriosis is an important clinical situation associated with subfertility. It would be very useful to identify patients at increased risk for endometriosis prior to laparoscopy. In the present study, we evaluate the demographic and clinical characteristics in a cohort of Portuguese

  19. Clinical and Radiographic Assessment of the Efficacy of Calcium Silicate Indirect Pulp Capping

    Science.gov (United States)

    Hashem, D.; Mannocci, F.; Patel, S.; Manoharan, A.; Brown, J.E.; Watson, T.F.

    2015-01-01

    The aims of this study were to assess the effectiveness of calcium silicate cement (Biodentine) versus glass ionomer cement (GIC; control group) as indirect pulp capping materials in patients with reversible pulpitis and to compare the effectiveness of cone beam computed tomography (CBCT) versus periapical (PA) radiographs in detecting PA changes at baseline (T0) and at 12 mo (T12) postoperatively. Seventy-two restorations (36 Biodentine, 36 Fuji IX) were placed randomly in 53 patients. CBCT/PA radiographs were taken at T0 and T12. Two calibrated examiners assessed the presence/absence and increase/decrease in the size of existing PA radiolucencies under standardized conditions. The Kappa coefficient evaluated statistically the effectiveness of CBCT versus PA radiographs in detecting PA changes. Chi-square/Mann-Whitney tests were used to evaluate the association between PA changes in CBCT with various clinical measures. Significance was predetermined at α = 0.05. Clinical success rates for Biodentine and Fuji IX GIC were 83.3%. CBCT was significantly more effective in detecting PA radiolucencies compared with radiographs (P = 0.0069). Of the teeth, 65.4% and 90.4% were deemed healthy using CBCT and PA radiographs, respectively, at T12. Healing/healed rates were 17.3%/0%, while new/progressed radiolucency were 30.8%/9.6% with CBCT/PA radiographs, respectively. Seventy-one percent of healed lesions had received Biodentine; 88% of new/progressed lesions received Fuji IX GIC. Teeth presenting with an initial CBCT PA lesion had a failure rate of 63%, whereas teeth with no initial lesion had a failure rate of 16%. Although no statistically significant difference was detected in the clinical efficacy of Biodentine/Fuji IX when used as indirect pulp capping materials in patients with reversible pulpitis, CBCT showed a significant difference in that most healed CBCT lesions had received Biodentine while most that did not heal received Fuji IX. Longer-term follow-up is

  20. Comparative Antibacterial Efficacy of Vitellaria paradoxa (Shea Butter Tree Extracts Against Some Clinical Bacterial Isolates

    Directory of Open Access Journals (Sweden)

    Kamoldeen Abiodun AJIJOLAKEWU

    2015-09-01

    Full Text Available The antibacterial activities of the ethanolic extracts of seed, leaf and stem bark of Vitellaria paradoxa were investigated. The extracts were tested against three clinical bacterial pathogens, Staphylococcus aureus, Escherichia coli and Klebsiella pneumoniae using the agar diffusion and the broth dilution techniques. Ethanolic extracts of the plant parts showed activity against all the bacterial pathogens tested. At the highest extract concentration (200 mg/ml, the leaf extract exhibited the highest antimicrobial activity, while no activity was detected at the lowest concentration (3.13 mg/ml against the tested isolates. Escherichia coli and Staphylococcus aureus were more susceptible to all extracts of V. paradoxa, while Klebsiella pneumoniae showed the least sensitivity. The efficacy of ethanolic extracts of Vitellaria paradoxa was compared to a commercial antibiotic streptomycin. There were differences in the minimum inhibitory concentration (MIC of all the Vitellaria paradoxa ethanolic extracts with respect to the type of organism. All extracts exhibited bacteriostatic effects against the tested organisms at the experimented concentrations. Qualitative phytochemical screening of the extracts revealed the presence of saponins, tannins and alkaloids as the active principles of Vitellaria paradoxa's antimicrobial activity. V. paradoxa could be used as a potential source of antibiotic substance for a drug development.

  1. A Double Blind Clinical Trial on the Efficacy of Honey Drop in Vernal Keratoconjunctivitis

    Directory of Open Access Journals (Sweden)

    Ali Salehi

    2014-01-01

    Full Text Available Purpose. This trial was designed to evaluate the efficacy and safety of topical honey eye drops in patients with diagnosed VKC. Methods. This clinical trial was conducted on 60 patients with diagnosed VKC. The patients were selected and randomly allocated between two groups of 30. Patients in two groups received honey eye drop (60% in artificial tear or placebo, other than cromolyn and fluorometholone 1% eye drops, to be used topically in each eye, four times per day. The patients were examined with slit lamp and torch at baseline and the follow-up visits on the 1st, 3rd, and 6th months of the study for redness, limbal papillae, and intraocular pressure. Results. Out of 60 patients who completed the study, 19 patients (31.7% were female. There was significant increase in eye pressure and reduction in redness as well as limbal papillae, following the consumption of the honey drop in honey group compared to placebo control group (P<0.05. At the end of trial, one patient in honey group and 7 ones in placebo group had limbal papillae (P<0.05. Conclusion. Topical honey eye drops, when used along with Cromolyn and Fluorometholone eye drops, might be beneficial for the treatment of VKC.

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

    Directory of Open Access Journals (Sweden)

    Guo-Ning Ye

    2018-02-01

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

  3. The capsular group B meningococcal vaccine, 4CMenB : clinical experience and potential efficacy.

    Science.gov (United States)

    Rollier, Christine S; Dold, Christina; Marsay, Leanne; Sadarangani, Manish; Pollard, Andrew J

    2015-01-01

    Capsular group B meningococcal disease is a leading cause of childhood meningitis and septicaemia. Up to 10% of sufferers die, and sequelae remain in > 30% of survivors. A vaccine, four component meningococcal group B ( 4CMenB ), designed with the aim to induce broad coverage against this highly variable bacterium, has been licensed in countries including in the European Union, Canada and Australia. Immunogenicity and safety data, published in peer-reviewed literature between 2004 and 2014, are presented in the context of the recent recommendation for the use of the vaccine in infants in the UK. 4CMenB induces significant reactogenicity when administered with routine infant vaccines, in particular with respect to fever rates. Fevers can be somewhat reduced using paracetamol. The efficacy of the vaccine is unknown but has been extrapolated from effectiveness data obtained from use of one of its components in New Zealand, immunogenicity data from clinical trials and estimation of coverage from in vitro studies. These data suggest that the vaccine will prevent a proportion of invasive meningococcal disease cases in infants and young children. Implementation and well-planned post-marketing surveillance will address uncertainties over field effectiveness.

  4. Clinical efficacy of edaravone for the treatment of amyotrophic lateral sclerosis.

    Science.gov (United States)

    Sawada, Hideyuki

    2017-05-01

    Amyotrophic lateral sclerosis (ALS) is a progressive, fatal, neurodegenerative disease. Although the pathogenesis remains unresolved, oxidative stress is known to play a pivotal role. Edaravone works in the central nervous system as a potent scavenger of oxygen radicals. In ALS mouse models, edaravone suppresses motor functional decline and nitration of tyrosine residues in the cerebrospinal fluid. Areas covered: Three clinical trials, one phase II open-label trial, and two phase III placebo-control randomized trials were reviewed. In all trials, the primary outcome measure was the changes in scores on the revised ALS functional rating scale (ALSFRS-R) to evaluate motor function of patients. Expert opinion: The phase II open label trial suggested that edaravone is safe and effective in ALS, markedly reducing 3-nitrotyrosine levels in the cerebrospinal fluid. One of the two randomized controlled trials showed beneficial effects in ALSFRS-R, although the differences were not significant. The last trial demonstrated that edaravone provided significant efficacy in ALSFRS-R scores over 24 weeks where concomitant use of riluzole was permitted. Eligibility was restricted to patients with a relatively short disease duration and preserved vital capacity. Therefore, combination therapy with edaravone and riluzole should be considered earlier.

  5. Alpha lipoic acid efficacy in burning mouth syndrome. A controlled clinical trial

    Science.gov (United States)

    Palacios-Sánchez, Begoña; Cerero-Lapiedra, Rocío; Llamas-Martínez, Silvia; Esparza-Gómez, Germán

    2015-01-01

    Background A double-blind placebo-controlled trial was conducted in order to evaluate the efficacy of alpha lipoic acid (ALA) and determine the statistical significance of the outcome variables. Burning mouth syndrome (BMS) is defined as an oral burning sensation in the absence of clinical signs which could justify the syndrome. Recent studies suggest the existence of neurological factors as a possible cause of the disease. Material and Methods 60 patients with BMS, in two groups: case group with 600 mg/day and placebo as control group; with follow up of 2 months. Results 64% of ALA patients reported some level of improvement, with a level of maintenance of 68.75% one month after treatment. 27.6% of the placebo group also demonstrated some reduction in BMS symptoms. Conclusions Long-term evolution and the intensity of symptoms are variables that reduce the probability of improvement with ALA treatment. Key words: Burning mouth syndrome, neuropathy, alpha lipoic acid. PMID:26034927

  6. Efficacy of chemomechanical caries removal in reducing cariogenic microbiota: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Michelle Mikhael AMMARI

    2014-08-01

    Full Text Available The aim of this study was to compare the efficacy of chemochemical methods (Carisolv™ and Papacárie® versus the manual method (excavators in reducing the cariogenic microbiota in dentine caries of primary teeth. Forty-six healthy children (5 to 9 years old having at least one primary tooth with a cavitated dentine carious lesion were included in the study. The teeth presented no clinical or radiographic signs of pulpal involvement. The sample of 74 teeth was randomly divided into three different groups: Papacárie® (n = 25, Carisolv™ (n = 27 and Manual (n = 22. Samples of carious and sound dentine were collected with sterile excavators before and after caries removal in the three groups. The dentine samples were transferred to glass tubes containing a 1mL thioglycollate medium used as a carrier and enriched for microbiological detection of mutans streptococci and Lactobacillus spp, after incubation for 6h at room temperature. The minimum detection value for colony forming units (CFU was 3.3 x 102 CFU/ml, and the results were converted into scores from 0 to 4. A significant difference was observed in relation to the microbiological scores before and after caries removal for all methods (Wilcoxon test; p < 0.001. The use of chemomechanical methods for caries removal did not improve the reduction of cariogenic microorganisms in dentine caries lesions, in comparison with manual excavation.

  7. A clinical comparison of safety and efficacy in phacoemulsification with versus without ophthalmic viscoelastic device.

    Science.gov (United States)

    Kugu, Suleyman; Erdogan, Gurkan; Sahin Sevim, M; Ozerturk, Yusuf

    2015-03-01

    To evaluate in a comparative manner the safety and efficacy of 1.0% sodium-Hyaluronate used during capsulorhexis and intraocular lens (IOL) implantation in phacoemulsification surgery. 1.0% sodium-Hyaluronate, which is commonly used as one of the ophthalmic viscoelastic devices, was compared to intraocular irrigating solution, which can bring up these effects. In addition, the effect of both methods on occurring corneal endothelial cell (CEC) loss was investigated. Each group comprised 19 eyes. The mean preoperative CEC density was 2525.68 ± 181.85 in Group H and 2514.16 ± 174.59 in Group V; no statistically significant difference was found between the groups (p > 0.05). Preoperative and postoperative first and twelfth week CEC densities were 2438.21 ± 198.12 (p  0.05). Although it was found that there was no statistically difference in terms of preventing CEC loss between 1.0% sodium-Hyaluronate and the irrigation method during phacoemulsification, it was observed clinically that 1.0% sodium-hyaluronate can make the procedure easy, safer, very helpful, especially for understanding phacoemulsification.

  8. Contraceptive efficacy and clinical performance of Nestorone implants in postpartum women.

    Science.gov (United States)

    Massai, M R; Díaz, S; Quinteros, E; Reyes, M V; Herreros, C; Zepeda, A; Croxatto, H B; Moo-Young, A J

    2001-12-01

    The objective of this study was to evaluate the contraceptive efficacy and clinical performance of a Nestorone subdermal implant (NES) in the postpartum period. NES (n = 100) and Copper T intrauterine device (T-Cu; n = 100) acceptors initiated contraception at 8 weeks postpartum and were followed at monthly intervals during the first year and at 3-month intervals thereafter. Pregnancy rates, breastfeeding performance, infant growth, bleeding pattern, and side effects were assessed. Blood and milk NES concentration were measured. No pregnancy occurred in 2195 and 2145 woman-months of NES implant and T-Cu use, respectively. No effect of NES on lactation and infant growth and no serious adverse events were observed. Lactational amenorrhea was significantly longer in NES users (353 +/- 20 days) than in T-Cu users (201 +/- 11 days). More NES users (55.8%) experienced prolonged bleedings than did T-Cu users (36.2%). Concentrations of NES in breast milk ranged between 54-135 pmol/liter. The Nestorone implant is a highly effective contraceptive, safe for breastfed infants because the steroid is inactive by the oral route.

  9. Clinical comparative study of efficacy of epley manoeuvre and semont manoeuvre in benign paroxysmal positional vertigo

    International Nuclear Information System (INIS)

    Majeed, M.A.; Haq, A.U.

    2015-01-01

    To compare the efficacy of Epley manoeuvre and Semont manoeuvre in the management of benign paroxysmal positional vertigo. Study Design: Randomized controlled trials. Place and Duration of Study: ENT Department Combined Military Hospital (CMH) Kharian and Gilgit from March 2005 to February 2010. Material and Methods: Hundred cases of benign paroxysmal positional vertigo (BPPV) were selected on Dix-Hallpike test by non probability convenient sampling technique and randomly divided into two groups of 50 cases each. Patients in group-1 were treated by Epley manoeuvre and patients in group-2 were treated by Semont manoeuvre. The patients were examined on first day, 3rd day, 7th day and after 01 month and clinical results were observed. Results: In group-1, 68% cases showed immediate resolution of symptoms, 74% cases on 3rd day, 80% cases on 7th day and total 82% cases recovered completely after one month. In group-2, 62% cases showed immediate resolution of symptoms, 68% cases on 3rd day, 74% cases on 7th day and total 78% cases showed complete recovery after 1 month. There was insignificant difference between the two groups regarding recovery at different follow ups. Conclusion: It was concluded that Epley and Semont manoeuvres are equally effective in the management of BPPV. (author)

  10. Clinical and Microbiologic Efficacy of a Water Filter Program in a Rural Honduran Community

    Directory of Open Access Journals (Sweden)

    Jaclyn Arquiette

    2014-01-01

    Full Text Available Water purification in the rural Honduras is a focus of the nonprofit organization Honduras Outreach Medical Brigade Relief Effort (HOMBRE. We assessed water filter use and tested filter microbiologic and clinical efficacy. A 22-item questionnaire assessed water sources, obtainment/storage, purification, and incidence of gastrointestinal disease. Samples from home clay-based filters in La Hicaca were obtained and paired with surveys from the same home. We counted bacterial colonies of four bacterial classifications from each sample. Sixty-five surveys were completed. Forty-five (69% individuals used a filter. Fifteen respondents reported diarrhea in their home in the last 30 days; this incidence was higher in homes not using a filter. Thirty-three paired water samples and surveys were available. Twenty-eight samples (85% demonstrated bacterial growth. A control sample was obtained from the local river, the principal water source; number and bacterial colony types were innumerable within 24 hours. Access to clean water, the use of filters, and other treatment methods differed within a geographically proximal region. Although the majority of the water samples failed to achieve bacterial eradication, water filters may sufficiently reduce bacterial coliform counts to levels below infectious inoculation. Clay water filters may be sustainable water treatment measures in resource poor settings.

  11. Efficacy of ozonized olive oil in the management of oral lesions and conditions: A clinical trial

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    Tarun Kumar

    2016-01-01

    Full Text Available The oral cavity is an open ecosystem that shows a dynamic balance between the entrance of microorganisms (bacterial, viral or fungal, colonization modalities, nutritional balance, and host defenses against their removal. The oral lesions including aphthous ulcerations, herpes labialis, oral candidiasis, oral lichen planus, and angular cheilitis some of the common entities encountered in the clinical practice. A variety of treatment options is available in the literature for all of these lesions and conditions. Topical ozone therapy is a minimally invasive technique that can be used for these conditions without any side effects. Aim and Objectives: To evaluate the efficacy of ozonized olive oil in the treatment of oral lesions and conditions. Materials and Methods: A longitudinal study was carried out on 50 patients (aphthous ulcerations, herpes labialis, oral candidiasis, oral lichen planus, and angular cheilitis. The ozonized olive oil was applied twice daily until the lesion regresses for a maximum of 6 months. Results: All the lesions regress in patients with aphthous ulcerations, herpes labialis, oral candidiasis and angular cheilitis or showed improvement in the signs and symptoms in oral lichen planus patients. No toxicity or side effect was observed in any of the patients. Conclusion: Ozone therapy though requires a gaseous form to be more effective, but topical form can also bring out the positive results without any toxicity or side effect. Hence, it can be considered as a minimally invasive therapy for the oral infective and immunological conditions.

  12. Current understanding on pharmacokinetics, clinical efficacy and safety of progestins for treating pain associated to endometriosis.

    Science.gov (United States)

    Barra, Fabio; Scala, Carolina; Ferrero, Simone

    2018-04-01

    Endometriosis is a chronic estrogen and progestogen responsive inflammatory disease associated with pain symptoms and infertility. The medical therapy of endometriosis aims to induce decidualization within the hormonally dependent ectopic endometrium, and it is often administered to ameliorate women' pain symptoms or to prevent post-surgical disease recurrence. A variety of progestins have been used in monotherapy for the medical management of women with endometriosis. Areas covered: This review aims to offer the reader a complete overview of pharmacokinetic (PK) and clinical efficacy of progestins for the treatment of endometriosis. Expert opinion: Each progestin has a distinct PK parameters and pharmacodynamics affinity not only for progesterone receptor, but also for other steroid receptors, such as estrogen, androgen, and glucocorticoid. Moreover, progestins can also be delivered in different formulations. All these characteristics influence their final biological effect. Randomized, controlled, non-blinded studies support the use of oral progestin-only treatment for pelvic pain associated with endometriosis. Currently, the only two progestins approved by Food and Drug Administration (FDA) for the treatment of endometriosis are norethindrone acetate (NETA) and depot medroxyprogesterone acetate (DMPA).

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

    Science.gov (United States)

    Levy, Jerrold H

    2005-09-15

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

  14. Interventional treatment of renal artery stenosis: a mid-term evaluation of clinical efficacy

    International Nuclear Information System (INIS)

    Liu Jing; Zhang Xitong

    2009-01-01

    Objective: To assess the clinical efficacy of interventional management for the treatment of renal artery stenosis. Methods: Percutaneous transluminal balloon renal angioplasty and / or percutaneous transluminal renal artery stenting were performed in 47 patients with renal artery stenosis (55 stenosed arteries in total). A follow-up study on the blood pressure and renal function was conducted and the results were statistically analyzed. Results: Fifty-four stenosed renal arteries were successfully reopened, of which only percutaneous transluminal balloon angioplasty was adopted in 17 and percutaneous transluminal renal artery stenting in 37. One patient died during the procedure. A follow-up for a mean period of (2.5 ± 0.6) years was carried out. The blood pressure determined at one (n = 46), 6 (n = 46), 12 (n = 33) and 24 (n = 29) months after the treatment was significantly decreased when compared to that determined before the treatment (P < 0.01). The clinical effective rate was 89.13% (41 / 46), 72.73% (24 / 33) and 62.07% (18 / 29), respectively. After the therapy,the renal function was improved in 5, remained unchanged in 33 and became worse in 3 patients. The comparison of the post-operative renograms (obtained within 2 months) with the pre-operative ones showed that in eight patients there was an increase in renal blood flow with an improvement in renal function impairment, which took a turn from severe degree to mild or moderate degree. Nevertheless, severe impairment in renal blood flow remained in 3 patients. Conclusion: Percutaneous transluminal balloon renal angioplasty and percutaneous transluminal renal artery stenting are safe and effective treatments for the renal artery stenosis, which also has a beneficial effect on the related renal hypertension and renal insufficiency. (authors)

  15. Clinical efficacy of different artificial tears for patients with xerophthalmia after phacoemulsification

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    Bing Wang

    2017-12-01

    Full Text Available AIM: To compare and analyze the clinical efficacy of different artificial tears for patients with xerophthalmia after phacoemulsification. METHODS: Retrospective analysis on the clinical data of 150 cases(150 eyestreated by phacoemulsification in our hospital from March 2014 to April 2017. And according to the artificial tears used, they were divided into Group A(control groupand B(application of sodium hyaluronate eye drops, Group C(used carbomer gel eye drops,50 cases 50 eyes in every group. We compared and analyzed the BUT, FL, SⅠt findings, OSDI scores preoperatively and 1wk, 1 and 3mo postoperatively, and visual acuity before and 3mo after operation in the three groups. RESULTS: There were no differences in BUT, FL, SⅠt and OSDI scores between the three groups before and at 1wk after the operation(P>0.05. At 1mo after operation, the levels of BUT and SⅠt in Group B and Group C were higher than those in Group A, and the scores of OSDI and FL were lower than those in Group A(PP>0.05. After 3mo, the levels of BUT and SⅠt in the Group B and Group C were higher than that in the Group A, and the FL level and OSDI score were lower than those in the Group A(PPPP>0.05. CONCLUSION: different types of artificial tear can improve the symptoms of dry eyes in patients age-related cataract after phacoemulsification, in which carbomer eye drops or lipid containing artificial tears improve postoperative dry eye symptoms and signs, and will not affect the recovery of visual acuity.

  16. CLINICAL EFFICACY OF THE ROBOT-ASSISTED LAPAROSCOPIC MYOMECTOMY (A REVIEW OF THE LITERATURE

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    V. A. Gudebskaya

    2016-01-01

    Full Text Available Rationale: One of the most complicated and unresolved problems in clinical medicine is the choice of an optimal method for organ-preservation treatment of uterine fibroids in women of childbearing age. Aim: To assess clinical efficacy of robot-assisted laparoscopic myomectomy. Materials and methods: The search was performed in PubMed, Embase, Trip, Cochrane, DocMe databases by keywords: “fibroids”, “robot”, “da Vinci”, “robotic myomectomy”, “robot-assisted myomectomy”. Results: We found 25 publications on robot-assisted laparoscopic myomectomy, including 6  papers on its reproductive outcomes (levels of evidence II–IV. Duration of robot-assisted surgery ranged from 132 to 261 minutes, intraoperative blood loss was in the range from 50 to 387 mL, postoperative hospital stay ranged from 1 to  3.9  days. There was a  lower percentage of intra- and postoperative complications after the robot-assisted interventions, compared to abdominal or classic laparoscopic access, as well as a lower percentage of conversion laparotomies compared to laparoscopy. Pregnancy rates after robotic myomectomy ranged from 16.7 to 69%. Only one case of uterine rupture after robot-assisted laparoscopic myomectomy has been described in the literature. Conclusion: Due to high cost of the method, the number of conducted studies is insufficient to evaluate the role of robotic technologies in the organ-preservation approach to uterine fibroids. Nevertheless, they suggest that robot-assisted laparoscopic myomectomy is justified in women of childbearing age who are planning pregnancy, with big centripetally growing intramural nodes and deformation of the uterine cavity. This technique on its own is an independent method for fertility restoration and could be the first step before the use of assisted reproductive technology.

  17. Plumbagin improves the efficacy of androgen deprivation therapy in prostate cancer: A pre-clinical study.

    Science.gov (United States)

    Abedinpour, Parisa; Baron, Véronique T; Chrastina, Adrian; Rondeau, Gaelle; Pelayo, Jennifer; Welsh, John; Borgström, Per

    2017-12-01

    Plumbagin is a candidate drug for the treatment of prostate cancer. Previous observations indicated that it may improve the efficacy of androgen deprivation therapy (ADT). This study evaluates the effectiveness of treatment with combinations of plumbagin and alternative strategies for ADT in mouse models of prostate cancer to support its clinical use. Plumbagin was administered per oral in a new sesame oil formulation. Standard toxicology studies were performed in rats. For tumor growth studies, mouse prostate cancer cell spheroids were placed on top of grafted prostate tissue in a dorsal chamber and allowed to form tumors. Mice were separated in various treatment groups and tumor size was measured over time by intra-vital microscopy. Survival studies were done in mice after injection of prostate cancer cells in the prostate of male animals. Androgen receptor (AR) levels were analyzed by Western blot from prostate cancer cells treated with plumbagin. Plumbagin caused a decrease in AR levels in vitro. In mice, plumbagin at 1 mg/kg in sesame oil displayed low toxicity and caused a 50% tumor regression when combined with castration. The combination of plumbagin with various forms of chemical ADT including treatment with a GnRH receptor agonist, a GnRH receptor antagonist, or CYP17A1 inhibitors, outperformed ADT alone, increasing mouse survival compared to the standard regimen of castration alone. In contrast, the combination of plumbagin with AR antagonists, such as bicalutamide and enzalutamide, showed no improvement over AR antagonists alone. Thus, plumbagin is effective in combination with drugs that prevent the synthesis of testosterone or its conversion to dihydrotestosterone, but not with drugs that bind to AR. Plumbagin significantly improves the effect of ADT drugs currently used in the clinic, with few side effects in mice. © 2017 Wiley Periodicals, Inc.

  18. Pharmacokinetics and clinical efficacy of phenobarbital in asphyxiated newborns treated with hypothermia: a thermopharmacological approach.

    Science.gov (United States)

    van den Broek, M P H; Groenendaal, F; Toet, M C; van Straaten, H L M; van Hasselt, J G C; Huitema, A D R; de Vries, L S; Egberts, A C G; Rademaker, C M A

    2012-10-01

    Therapeutic hypothermia can influence the pharmacokinetics and pharmacodynamics of drugs, the discipline which is called thermopharmacology. We studied the effect of therapeutic hypothermia on the pharmacokinetics of phenobarbital in asphyxiated neonates, and the clinical efficacy and the effect of phenobarbital on the continuous amplitude-integrated electroencephalography (aEEG) in a prospective study. Data were obtained from the prospective SHIVER study, performed in two of the ten Dutch level III neonatal intensive care units. Phenobarbital data were collected between 2008 and 2010. Newborns were eligible for inclusion if they had a gestational age of at least 36 weeks and presented with perinatal asphyxia and encephalopathy. According to protocol in both hospitals an intravenous (repeated) loading dose of phenobarbital 20 mg/kg divided in 1-2 doses was administered if seizures occurred or were suspected before or during the hypothermic phase. Phenobarbital plasma concentrations were measured in plasma using a fluorescence polarization immunoassay. aEEG was monitored continuously. A one-compartmental population pharmacokinetic/pharmacodynamic model was developed using a multi-level Markov transition model. No (clinically relevant) effect of moderate therapeutic hypothermia on phenobarbital pharmacokinetics could be identified. The observed responsiveness was 66%. While we still advise an initial loading dose of 20 mg/kg, clinicians should not be reluctant to administer an additional dose of 10-20 mg/kg. An additional dose should be given before switching to a second-line anticonvulsant drug. Based on our pharmacokinetic/pharmacodynamic model, administration of phenobarbital under hypothermia seems to reduce the transition rate from a continuous normal voltage (CNV) to discontinuous normal voltage aEEG background level in hypothermic asphyxiated newborns, which may be attributed to the additional neuroprotection of phenobarbital in infants with a CNV pattern.

  19. Selective Embolization for Post-Endoscopic Sphincterotomy Bleeding: Technical Aspects and Clinical Efficacy

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    So, Young Ho; Choi, Young Ho [Seoul National University Boramae Medical Center, Seoul (Korea, Republic of); Chung, Jin Wook; Jae, Hwan Jun; Park, Jae Hyung [Seoul National University Hospital, Seoul (Korea, Republic of); Song, Soon Young [Hanyang University Hospital, Seoul (Korea, Republic of)

    2012-01-15

    The objective of this study was to evaluate the technical aspects and clinical efficacy of selective embolization for post-endoscopic sphincterotomy bleeding. We reviewed the records of 10 patients (3%; M:F 6:4; mean age, 63.3 years) that underwent selective embolization for post-endoscopic sphincterotomy bleeding among 344 patients who received arteriography for nonvariceal upper gastrointestinal bleeding from 2000 to 2009. We analyzed the endoscopic procedure, onset of bleeding, underlying clinical condition, angiographic findings, interventional procedure, and outcomes in these patients. Among the 12 bleeding branches, primary success of hemostasis was achieved in 10 bleeding branches (83%). Secondary success occurred in two additional bleeding branches (100%) after repeated embolization. In 10 patients, post-endoscopic sphincterotomy bleedings were detected during the endoscopic procedure (n = 2, 20%) or later (n = 8, 80%), and the delay was from one to eight days (mean, 2.9 days; {+-} 2.3). Coagulopathy was observed in three patients. Eight patients had a single bleeding branch, whereas two patients had two branches. On the selective arteriography, bleeding branches originated from the posterior pancreaticoduodenal artery (n = 8, 67%) and anterior pancreaticoduodenal artery (n = 4, 33%), respectively. Superselection was achieved in four branches and the embolization was performed with n-butyl cyanoacrylate. The eight branches were embolized by combined use of coil, n-butyl cyanoacrylate, or Gelfoam. After the last embolization, there was no rebleeding or complication related to embolization. Selective embolization is technically feasible and an effective procedure for post-endoscopic sphincterotomy bleeding. In addition, the posterior pancreaticoduodenal artery is the main origin of the causative vessels of post-endoscopic sphincterotomy bleeding.

  20. Selective Embolization for Post-Endoscopic Sphincterotomy Bleeding: Technical Aspects and Clinical Efficacy

    International Nuclear Information System (INIS)

    So, Young Ho; Choi, Young Ho; Chung, Jin Wook; Jae, Hwan Jun; Park, Jae Hyung; Song, Soon Young

    2012-01-01

    The objective of this study was to evaluate the technical aspects and clinical efficacy of selective embolization for post-endoscopic sphincterotomy bleeding. We reviewed the records of 10 patients (3%; M:F 6:4; mean age, 63.3 years) that underwent selective embolization for post-endoscopic sphincterotomy bleeding among 344 patients who received arteriography for nonvariceal upper gastrointestinal bleeding from 2000 to 2009. We analyzed the endoscopic procedure, onset of bleeding, underlying clinical condition, angiographic findings, interventional procedure, and outcomes in these patients. Among the 12 bleeding branches, primary success of hemostasis was achieved in 10 bleeding branches (83%). Secondary success occurred in two additional bleeding branches (100%) after repeated embolization. In 10 patients, post-endoscopic sphincterotomy bleedings were detected during the endoscopic procedure (n = 2, 20%) or later (n = 8, 80%), and the delay was from one to eight days (mean, 2.9 days; ± 2.3). Coagulopathy was observed in three patients. Eight patients had a single bleeding branch, whereas two patients had two branches. On the selective arteriography, bleeding branches originated from the posterior pancreaticoduodenal artery (n = 8, 67%) and anterior pancreaticoduodenal artery (n = 4, 33%), respectively. Superselection was achieved in four branches and the embolization was performed with n-butyl cyanoacrylate. The eight branches were embolized by combined use of coil, n-butyl cyanoacrylate, or Gelfoam. After the last embolization, there was no rebleeding or complication related to embolization. Selective embolization is technically feasible and an effective procedure for post-endoscopic sphincterotomy bleeding. In addition, the posterior pancreaticoduodenal artery is the main origin of the causative vessels of post-endoscopic sphincterotomy bleeding.

  1. Smokers' responses toward cigarette pack warning labels in predicting quit intention, stage of change, and self-efficacy.

    Science.gov (United States)

    Fathelrahman, Ahmed I; Omar, Maizurah; Awang, Rahmat; Borland, Ron; Fong, Geoffrey T; Hammond, David; Zain, Zarihah

    2009-03-01

    This paper is concerned with the effects of cigarette pack warning labels on quitting intentions. We examined whether different responses among smokers toward cigarette pack warning labels could predict quit intentions and self-efficacy in quitting. Variables studied were "noticing warning labels during last month," "reading or looking closely at warning labels," "avoiding looking at labels during last month," "thinking about health risks of smoking because of the warning labels, "more likely to quit because of the warning labels," and "stopping from having a cigarette when about to smoke one because of the labels." A total of 2,006 adult smokers in Malaysia were surveyed in face-to-face interviews using a standardized questionnaire. Of those, 1,919 male smokers were included in the analyses. The responses "more likely to quit because of the warning labels" and "stopped from having a cigarette when about to smoke one" significantly predicted all stages of change and self-efficacy, independent of the other measures. In addition, thinking about the health risks and reading the warnings more often added extra predictive capacity but only in the early stages of contemplating change. Less intense processing of the information may be important in initiating thoughts, but cognitions about quitting and foregoing cigarettes are the key mechanisms by which warnings stimulate quitting intentions and help smokers feel capable of succeeding. Malaysian smokers appear to respond to warnings in ways comparable with those from developed countries.

  2. Oxytocin efficacy is modulated by dosage and oxytocin receptor genotype in young adults with high-functioning autism: a 24-week randomized clinical trial.

    Science.gov (United States)

    Kosaka, H; Okamoto, Y; Munesue, T; Yamasue, H; Inohara, K; Fujioka, T; Anme, T; Orisaka, M; Ishitobi, M; Jung, M; Fujisawa, T X; Tanaka, S; Arai, S; Asano, M; Saito, D N; Sadato, N; Tomoda, A; Omori, M; Sato, M; Okazawa, H; Higashida, H; Wada, Y

    2016-08-23

    Recent studies have suggested that long-term oxytocin administration can alleviate the symptoms of autism spectrum disorder (ASD); however, factors influencing its efficacy are still unclear. We conducted a single-center phase 2, pilot, randomized, double-blind, placebo-controlled, parallel-group, clinical trial in young adults with high-functioning ASD, to determine whether oxytocin dosage and genetic background of the oxytocin receptor affects oxytocin efficacy. This trial consisted of double-blind (12 weeks), open-label (12 weeks) and follow-up phases (8 weeks). To examine dose dependency, 60 participants were randomly assigned to high-dose (32 IU per day) or low-dose intranasal oxytocin (16 IU per day), or placebo groups during the double-blind phase. Next, we measured single-nucleotide polymorphisms (SNPs) in the oxytocin receptor gene (OXTR). In the intention-to-treat population, no outcomes were improved after oxytocin administration. However, in male participants, Clinical Global Impression-Improvement (CGI-I) scores in the high-dose group, but not the low-dose group, were significantly higher than in the placebo group. Furthermore, we examined whether oxytocin efficacy, reflected in the CGI-I scores, is influenced by estimated daily dosage and OXTR polymorphisms in male participants. We found that >21 IU per day oxytocin was more effective than ⩽21 IU per day, and that a SNP in OXTR (rs6791619) predicted CGI-I scores for ⩽21 IU per day oxytocin treatment. No severe adverse events occurred. These results suggest that efficacy of long-term oxytocin administration in young men with high-functioning ASD depends on the oxytocin dosage and genetic background of the oxytocin receptor, which contributes to the effectiveness of oxytocin treatment of ASD.

  3. CLINICAL AND IMMUNOPATHOLOGIC CHARACTERISTICS OF EARLY NEONATAL SEPSIS IN INFANTS OF DIFFERENT GESTATIONAL AGE AND CLINICAL AND ECONOMICAL EVALUATION OF IMMUNOSUPPORTIVE THERAPY EFFICACY

    Directory of Open Access Journals (Sweden)

    I.G. Soldatova

    2011-01-01

    Full Text Available Study objective — to study clinical and immunopathologic characteristics of early neonatal sepsis in infants of different gestational age and to perform clinical and economical evaluation of immunosupportive therapy with Pentaglobin efficacy in complex treatment of this disease. 79 infants diagnosed with neonatal sepsis were included into prospective study. These patients were divided into 3 subgroups in order to evaluate clinical and economical efficacy of immunosupportive therapy: subgroup A (n = 38 — patients receiving. Pentaglobin as part of basic complex treatment from 3–6 days of life; subgroup B (n = 27 — from 7–10 days of life; subgroup C  (n = 27 — patients treated without Pentaglobin. Proven high clinical and economical efficacy of immunoglobulin preparations as a part of complex treatment of neonatal sepsis allows to recommend this type of therapy for a wide application in neonatology as a part of neonatal sepsis treatment.Key words: early neonatal sepsis, prematurity, extremely low body mass, immunosupportive therapy, intravenous immunoglobines, clinical and economical analysis, neonatal sepsis. (Voprosy sovremennoi pediatrii — Current Pediatrics. — 2011; 10 (6: 52–61

  4. Genetic tests for predicting the toxicity and efficacy of anticancer chemotherapy.

    Science.gov (United States)

    Mladosievicova, B; Carter, A; Kristova, V

    2007-01-01

    The standard anticancer therapy based "on one size fits all" modality has been determined to be ineffective or to be the cause of adverse drug reactions in many oncologic patients. Most pharmacogenetic and pharmacogenomic studies so far have been focused on toxicity of anticancer drugs such as 6-mercaptopurine, thioguanine, irinotecan, methotrexate, 5-fluorouracil (5-FU). Variation in genes are known to influence not only toxicity, but also efficacy of chemotherapeutics such as platinum analogues, 5-FU and irinotecan. The majority of current pharmacogenetic studies focus on single enzyme deficiencies as predictors of drug effects; however effects of most anticancer drugs are determined by the interplay of several gene products. These effects are polygenic in nature. This review briefly describes genetic variations that may impact efficacy and toxicity of drugs used in cancer chemotherapy.

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

    Science.gov (United States)

    McClellan, K J; Spencer, C M

    1998-04-01

    volunteers. Modafinil reduced the impairment of cognitive performance induced by sleep deprivation in volunteers, suppressed microsleeps and reduced the length of recovery sleep required. However, volunteers treated with modafinil reported recovery sleep patterns which were similar to those of placebo recipients. Studies in volunteers indicate that modafinil has less abuse potential than dexamphetamine or methylphenidate. Peak plasma concentrations of modafinil (mean 4.82 mg/L) were reached 2.3 hours after a single 200mg oral dose in healthy volunteers. Over the dose range 200 to 600mg, the pharmacokinetics of modafinil were linear and dose dependent. Orally administered modafinil is extensively biotransformed in the liver to the inactive metabolites modafinil acid and modafinil sulphone, before being eliminated primarily in the urine (elimination half-life 9 to 14 hours). The pharmacokinetics of modafinil are not affected to a clinically significant extent by volunteer age or food intake, but both the maximum plasma concentration and the elimination half-life of the drug are increased in patients with hepatic or renal impairment. The efficacy of modafinil 200 or 400 mg/day was rated as good or excellent (using a 4-point scale) in 84 of 131 evaluable patients (64%) with excessive daytime sleepiness treated for 1 to 114 months in a noncomparative study. 53 patients withdrew from the study (43 because of loss of efficacy). In another study, 1 or 2 months' treatment with modafinil reduced or eliminated symptoms of excessive daytime sleepiness in 17 of 24 patients with narcolepsy. Modafinil 200 or 400 mg/day for 9 weeks significantly increased daytime sleep latency and reduced daytime sleepiness compared with placebo in patients with narcolepsy, but did not suppress cataplexy. It tended to improve psychomotor performance, although this effect was variable. Importantly, modafinil did not affect patients' nocturnal sleep parameters, ability to nap when necessary or feelings on

  6. Antiremodelling Efficacy and Clinical Safety of Zofenopril in Patients with Grade 1and 2 Hypertension

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    Guzal J. Abdullaeva

    2015-12-01

    Full Text Available Objective: to estimate the antihypertensive, antiremodelling efficacy and clinical tolerability of the monotherapy with Zofenopril in patients with Grade 1 and 2 hypertension (HT 1 and 2 Materials and Methods: The study included 30 patients aged from 30 to 60 years with HT 1 and 2 (ESH/ESC, 2013 without severe comorbidities and cardiovascular complications. Zofenopril was prescribed as monotherapy to HT patients who had never been treated before or patients after one week of lavage from previous antihypertensive therapy, who did not reach target levels of BP. Before and during treatment all patients were checked on office BP using Korotkov’s method and ambulatory blood pressure monitoring (ABPM. Echocardiography and Doppler sonography were carried out by standard methods using the recommendations of the American Society of Echocardiography. Intima-media thickness (IMT of the carotid artery and brachial artery was measured by a 7.5MHz high-resolution ultrasound. Assessment of flow-mediated dilation (FMD of the brachial artery was used as a method of determining endothelial function. Results: A 12-week monotherapy with Zofenopril in average daily dose of 36.0±19.54 mg showed a high antihypertensive efficacy and a good safety profile without side effects. We noted a reliable decrease in systolic BP (SBP, diastolic BP (DBP, mean BP, and pulse pressure (PP by -19.53±5.93%, -18.64±7.18%, BP -19.05±6.14%, and -20.65±12.07%, respectively. Target SBP, DBP, and SBP+DBP were reached in 90%, 86.6%, and 83.3% of patients, respectively. We found a significant regression of LVH, significant improvement in volume indicators of LV echogeometry and parameters of FMD of the brachial artery, as well as a decrease in IMT of carotid and brachial arteries. Monotherapy with Zofenopril showed metabolic neutrality regarding the lipid and carbohydrate metabolism, a good safety profile without the side effects and undesired events.

  7. High-Level Disinfection of Otorhinolaryngology Clinical Instruments: An Evaluation of the Efficacy and Cost-effectiveness of Instrument Storage.

    Science.gov (United States)

    Yalamanchi, Pratyusha; Yu, Jason; Chandler, Laura; Mirza, Natasha

    2018-01-01

    Objectives Despite increasing interest in individual instrument storage, risk of bacterial cross-contamination of otorhinolaryngology clinic instruments has not been assessed. This study is the first to determine the clinical efficacy and cost-effectiveness of standard high-level disinfection and clinic instrument storage. Methods To assess for cross-contamination, surveillance cultures of otorhinolaryngology clinic instruments subject to standard high-level disinfection and storage were obtained at the start and end of the outpatient clinical workday. Rate of microorganism recovery was compared with cultures of instruments stored in individual peel packs and control cultures of contaminated instruments. Based on historical clinic data, the direct allocation method of cost accounting was used to determine aggregate raw material cost and additional labor hours required to process and restock peel-packed instruments. Results Among 150 cultures of standard high-level disinfected and co-located clinic instruments, 3 positive bacterial cultures occurred; 100% of control cultures were positive for bacterial species ( P cost of individual semicritical instrument storage at $97,852.50 per year. Discussion With in vitro inoculation of >200 otorhinolaryngology clinic instruments, this study demonstrates that standard high-level disinfection and storage are equally efficacious to more time-consuming and expensive individual instrument storage protocols, such as peel packing, with regard to bacterial contamination. Implications for Practice Standard high-level disinfection and storage are equally effective to labor-intensive and costly individual instrument storage protocols.

  8. Comparison of statistical and clinical predictions of functional outcome after ischemic stroke.

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    Douglas D Thompson

    Full Text Available To determine whether the predictions of functional outcome after ischemic stroke made at the bedside using a doctor's clinical experience were more or less accurate than the predictions made by clinical prediction models (CPMs.A prospective cohort study of nine hundred and thirty one ischemic stroke patients recruited consecutively at the outpatient, inpatient and emergency departments of the Western General Hospital, Edinburgh between 2002 and 2005. Doctors made informal predictions of six month functional outcome on the Oxford Handicap Scale (OHS. Patients were followed up at six months with a validated postal questionnaire. For each patient we calculated the absolute predicted risk of death or dependence (OHS≥3 using five previously described CPMs. The specificity of a doctor's informal predictions of OHS≥3 at six months was good 0.96 (95% CI: 0.94 to 0.97 and similar to CPMs (range 0.94 to 0.96; however the sensitivity of both informal clinical predictions 0.44 (95% CI: 0.39 to 0.49 and clinical prediction models (range 0.38 to 0.45 was poor. The prediction of the level of disability after stroke was similar for informal clinical predictions (ordinal c-statistic 0.74 with 95% CI 0.72 to 0.76 and CPMs (range 0.69 to 0.75. No patient or clinician characteristic affected the accuracy of informal predictions, though predictions were more accurate in outpatients.CPMs are at least as good as informal clinical predictions in discriminating between good and bad functional outcome after ischemic stroke. The place of these models in clinical practice has yet to be determined.

  9. The Efficacy of Violence Prediction: A Meta-Analytic Comparison of Nine Risk Assessment Tools

    Science.gov (United States)

    Yang, Min; Wong, Stephen C. P.; Coid, Jeremy

    2010-01-01

    Actuarial risk assessment tools are used extensively to predict future violence, but previous studies comparing their predictive accuracies have produced inconsistent findings as a result of various methodological issues. We conducted meta-analyses of the effect sizes of 9 commonly used risk assessment tools and their subscales to compare their…

  10. Analysis of Factors that Predict Clinical Performance in Medical School

    Science.gov (United States)

    White, Casey B.; Dey, Eric L.; Fantone, Joseph C.

    2009-01-01

    Academic achievement indices including GPAs and MCAT scores are used to predict the spectrum of medical student academic performance types. However, use of these measures ignores two changes influencing medical school admissions: student diversity and affirmative action, and an increased focus on communication skills. To determine if GPA and MCAT…

  11. Predicting activities after stroke : what is clinically relevant?

    NARCIS (Netherlands)

    Kwakkel, G.; Kollen, B. J.

    Knowledge about factors that determine the final outcome after stroke is important for early stroke management, rehabilitation goals, and discharge planning. This narrative review provides an overview of current knowledge about the prediction of activities after stroke. We reviewed the pattern of

  12. predicted peak expiratory flow in human and the clinical implication ...

    African Journals Online (AJOL)

    DR. AMINU

    predicted PEF varied widely across formulae and choice of a particular formula may alter guideline- base care. This work has therefore accepted a recently published population-base equation proposed as the reference standard for future asthma guidelines. Keywords: Peak expiratory flow, Asthma, Practice guidelines, ...

  13. Assessing Discriminative Performance at External Validation of Clinical Prediction Models.

    Directory of Open Access Journals (Sweden)

    Daan Nieboer

    Full Text Available External validation studies are essential to study the generalizability of prediction models. Recently a permutation test, focusing on discrimination as quantified by the c-statistic, was proposed to judge whether a prediction model is transportable to a new setting. We aimed to evaluate this test and compare it to previously proposed procedures to judge any changes in c-statistic from development to external validation setting.We compared the use of the permutation test to the use of benchmark values of the c-statistic following from a previously proposed framework to judge transportability of a prediction model. In a simulation study we developed a prediction model with logistic regression on a development set and validated them in the validation set. We concentrated on two scenarios: 1 the case-mix was more heterogeneous and predictor effects were weaker in the validation set compared to the development set, and 2 the case-mix was less heterogeneous in the validation set and predictor effects were identical in the validation and development set. Furthermore we illustrated the methods in a case study using 15 datasets of patients suffering from traumatic brain injury.The permutation test indicated that the validation and development set were homogenous in scenario 1 (in almost all simulated samples and heterogeneous in scenario 2 (in 17%-39% of simulated samples. Previously proposed benchmark values of the c-statistic and the standard deviation of the linear predictors correctly pointed at the more heterogeneous case-mix in scenario 1 and the less heterogeneous case-mix in scenario 2.The recently proposed permutation test may provide misleading results when externally validating prediction models in the presence of case-mix differences between the development and validation population. To correctly interpret the c-statistic found at external validation it is crucial to disentangle case-mix differences from incorrect regression coefficients.

  14. Correlation of clinical predictions and surgical results in maxillary superior repositioning.

    Science.gov (United States)

    Tabrizi, Reza; Zamiri, Barbad; Kazemi, Hamidreza

    2014-05-01

    This is a prospective study to evaluate the accuracy of clinical predictions related to surgical results in subjects who underwent maxillary superior repositioning without anterior-posterior movement. Surgeons' predictions according to clinical (tooth show at rest and at the maximum smile) and cephalometric evaluation were documented for the amount of maxillary superior repositioning. Overcorrection or undercorrection was documented for every subject 1 year after the operations. Receiver operating characteristic curve test was used to find a cutoff point in prediction errors and to determine positive predictive value (PPV) and negative predictive value. Forty subjects (14 males and 26 females) were studied. Results showed a significant difference between changes in the tooth show at rest and at the maximum smile line before and after surgery. Analysis of the data demonstrated no correlation between the predictive data and the surgical results. The incidence of undercorrection (25%) was more common than overcorrection (7.5%). The cutoff point for errors in predictions was 5 mm for tooth show at rest and 15 mm at the maximum smile. When the amount of the presurgical tooth show at rest was more than 5 mm, 50.5% of clinical predictions did not match the clinical results (PPV), and 75% of clinical predictions showed the same results when the tooth show was less than 5 mm (negative predictive value). When the amount of presurgical tooth shown in the maximum smile line was more than 15 mm, 75% of clinical predictions did not match with clinical results (PPV), and 25% of the predictions had the same results because the tooth show at the maximum smile was lower than 15 mm. Clinical predictions according to the tooth show at rest and at the maximum smile have a poor correlation with clinical results in maxillary superior repositioning for vertical maxillary excess. The risk of errors in predictions increased when the amount of superior repositioning of the maxilla increased

  15. Clinical and immunological efficacy of combination therapy of children with measles

    Directory of Open Access Journals (Sweden)

    V. N. Timchenko

    2016-01-01

    Full Text Available The aim of the study was to assess the clinical and immunological efficacy of recombinant interferon Alfa-2b. Examined 34 children aged from 1 year to 7 years carrying medium to heavy degree of measles. All patients were not vaccinated against measles. In the treatment of 18 people (Control group were used only basic therapy (pathogenic, symptomatic. At 16 people (Study group used a combination therapy (basic + Viferon. As an antiviral agent used and immunotropic preparation of human recombinant interferon alfa-2b in the form of rectal suppositories – Viferon (OOO «Feron», Russia. Immunological patient survey was conducted in the dynamics of the disease – during the height (in 1-6 days the rash and in convalescence period (10-16 days rash. Indicators of cellular immunity (leukocytes, lymphocytes, CD3 +, CD3 + CD (16 + 56 +, CD3 + CD4 +, CD3 + CD8 +, CD4 + CD8 +, CD3-CD8 +, CD3-CD (16 + 56, CD19 +, CD25 +, CD3 + HLA DR +, CD (16 + 56 + HLA DR +, HLA DR +, CD95 + were evaluated by flow cytometry. To assess the production of IFN-α and IFN-γ in the samples of peripheral blood were cultured in the CO2 incubator for 18 hours at 37 C and 4% CO2. The supernatants of cell culture were investigated with the purpose of studying spontaneous and induced production of interferon alpha and gamma. The concentrations of interferon α and γ (IFNα, IFNγ in the blood serum, as well as levels of spontaneous and induced cytokine production data of blood cells of sick children was determined by ELISA. All the children at the peak of the disease found a dramatic inhibition of cellular immunity and the production of cytokines, which is consistent with the concept of «measles anergy» accepted in the scientific literature. The period of convalescence oppression immunity indices remained, but it was less pronounced in the group of children treated with the drug of human recombinant interferon alfa-2b -Viferon. Clinical efficacy

  16. Prediction of renal mass aggressiveness using clinical and radiographic features: a global, multicentre prospective study

    NARCIS (Netherlands)

    Golan, Shay; Eggener, Scott; Subotic, Svetozar; Barret, Eric; Cormio, Luigi; Naito, Seiji; Tefekli, Ahmet; Pilar Laguna Pes, M.

    2016-01-01

    To examine the ability of preoperative clinical characteristics to predict histological features of renal masses (RMs). Data from consecutive patients with clinical stage I RMs treated surgically between 2010 and 2011 in the Clinical Research Office of Endourology Society (CROES) Renal Mass Registry

  17. Pressure Ulcers in Adults: Prediction and Prevention. Clinical Practice Guideline Number 3.

    Science.gov (United States)

    Agency for Health Care Policy and Research (DHHS/PHS), Rockville, MD.

    This package includes a clinical practice guideline, quick reference guide for clinicians, and patient's guide to predicting and preventing pressure ulcers in adults. The clinical practice guideline includes the following: overview of the incidence and prevalence of pressure ulcers; clinical practice guideline (introduction, risk assessment tools…

  18. A framework for multiple kernel support vector regression and its applications to siRNA efficacy prediction.

    Science.gov (United States)

    Qiu, Shibin; Lane, Terran

    2009-01-01

    The cell defense mechanism of RNA interference has applications in gene function analysis and promising potentials in human disease therapy. To effectively silence a target gene, it is desirable to select appropriate initiator siRNA molecules having satisfactory silencing capabilities. Computational prediction for silencing efficacy of siRNAs can assist this screening process before using them in biological experiments. String kernel functions, which operate directly on the string objects representing siRNAs and target mRNAs, have been applied to support vector regression for the prediction and improved accuracy over numerical kernels in multidimensional vector spaces constructed from descriptors of siRNA design rules. To fully utilize information provided by string and numerical data, we propose to unify the two in a kernel feature space by devising a multiple kernel regression framework where a linear combination of the kernels is used. We formulate the multiple kernel learning into a quadratically constrained quadratic programming (QCQP) problem, which although yields global optimal solution, is computationally demanding and requires a commercial solver package. We further propose three heuristics based on the principle of kernel-target alignment and predictive accuracy. Empirical results demonstrate that multiple kernel regression can improve accuracy, decrease model complexity by reducing the number of support vectors, and speed up computational performance dramatically. In addition, multiple kernel regression evaluates the importance of constituent kernels, which for the siRNA efficacy prediction problem, compares the relative significance of the design rules. Finally, we give insights into the multiple kernel regression mechanism and point out possible extensions.

  19. Efficacy of curcumin in the treatment for oral submucous fibrosis - A randomized clinical trial.

    Science.gov (United States)

    Hazarey, Vinay K; Sakrikar, Aditee R; Ganvir, Sindhu M

    2015-01-01

    Oral submucous fibrosis (OSF) is a chronic, insidious disease that is associated with significant functional morbidity and an increased risk for malignancy. Turmeric and its active ingredient "curcumin" are being studied upon as chemopreventive agents in various diseases. The present study aims to determine the efficacy of curcumin in the treatment of OSF. Thirty clinically diagnosed OSF patients were divided into two groups, 15 patients in each group from the Outpatient Department. Test group patients were treated with Longvida (curcumin) lozenges and control group with Tenovate ointment (clobetasol propionate (0.05%). The treatment was given for 3 months duration and follow-up was done for 6 months. Both the groups were advised for physiotherapy exercises by mouth exercise device. The baseline and follow-up results were compared for IIO (interincisal distance on maximum mouth opening), Visual Analogue Scale (VAS) for normal food and VAS for spicy food. The test group showed 5.93 (±2.37) mm increase in mouth opening compared to 2.66 (±1.76) mm of the control group. In relation to VAS scale with spicy and normal food the average reduction was 64 (42-73) and 77 (70.5-82) as compared to 34 (14.5-64.5) and 64 (46-75.5) respectively in control group. The test group results achieved in the treatment span was sustained in the follow-up (P < 0.05) compared to control group which showed statistically significant (P < 0.05) relapse. It can be concluded that combination strategies for the management of OSF which include the stoppage of causative ill habits, appropriate medicinal and physiotherapy management is more efficient than single therapeutic modality. It is evident from the study that curcumin holds good promise in the treatment of OSF in future.

  20. Randomized Clinical Trial to Assess the Efficacy of Radiotherapy in Primary Mediastinal Large B-Lymphoma

    Energy Technology Data Exchange (ETDEWEB)

    Aviles, Agustin, E-mail: agustin.aviles@imss.gob.mx [Oncology Research Unit, Oncology Hospital, National Medical Center, IMSS, Mexico, D. F. (Mexico); Neri, Natividad [Department of Hematology, Oncology Hospital, National Medical Center, IMSS, Mexico, D. F. (Mexico); Fernandez, Raul [Department of Radiation Therapy, Oncology Hospital, National Medical Center, IMSS, Mexico, D. F. (Mexico); Huerta-Guzman, Judith; Nambo, Maria J. [Department of Hematology, Oncology Hospital, National Medical Center, IMSS, Mexico, D. F. (Mexico)

    2012-07-15

    Purpose: We developed a controlled clinical trial to assess the efficacy and toxicity of adjuvant-involved field radiotherapy (IFRT) in patients with primary mediastinal B-cell lymphoma that achieved complete response after the patients were treated with cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab (R-CHOP-14). Methods and Materials: Between January 2001 and June 2004, 124 consecutive patients who were in complete remission after dose dense chemotherapy and rituximab administration (R-CHOP14) were randomly assigned to received IFRT (30 Gy). Sixty-three patients received IFR, and 61 patients did not (control group). Results: The study aimed to include 182 patients in each arm but was closed prematurely because in a security analysis (June 2004), progression and early relapse were more frequent in patients that did not received IFRT. Patients were followed until March 2009, at which point actuarial curves at 10 years showed that progression free-survival was 72% in patients who received IFR and 20% in the control group (p < 0.001), overall survival was 72% and 31%, respectively (p < 0.001). Acute toxicity was mild and well tolerated. Discussion: Adjuvant radiotherapy to sites of bulky disease was the only difference to have an improvement in outcome in our patients; the use of rituximab during induction did not improve complete response rates and did affect overall survival; patients who received rituximab but not IFRT had a worse prognosis. Conclusions: The use of IFRT in patients with primary mediastinal B-cell lymphoma who achieved complete response remain as the best treatment available, even in patients that received rituximab during induction.

  1. Randomized Clinical Trial to Assess the Efficacy of Radiotherapy in Primary Mediastinal Large B-Lymphoma

    International Nuclear Information System (INIS)

    Avilés, Agustin; Neri, Natividad; Fernández, Raúl; Huerta-Guzmán, Judith; Nambo, María J.

    2012-01-01

    Purpose: We developed a controlled clinical trial to assess the efficacy and toxicity of adjuvant-involved field radiotherapy (IFRT) in patients with primary mediastinal B-cell lymphoma that achieved complete response after the patients were treated with cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab (R-CHOP-14). Methods and Materials: Between January 2001 and June 2004, 124 consecutive patients who were in complete remission after dose dense chemotherapy and rituximab administration (R-CHOP14) were randomly assigned to received IFRT (30 Gy). Sixty-three patients received IFR, and 61 patients did not (control group). Results: The study aimed to include 182 patients in each arm but was closed prematurely because in a security analysis (June 2004), progression and early relapse were more frequent in patients that did not received IFRT. Patients were followed until March 2009, at which point actuarial curves at 10 years showed that progression free-survival was 72% in patients who received IFR and 20% in the control group (p < 0.001), overall survival was 72% and 31%, respectively (p < 0.001). Acute toxicity was mild and well tolerated. Discussion: Adjuvant radiotherapy to sites of bulky disease was the only difference to have an improvement in outcome in our patients; the use of rituximab during induction did not improve complete response rates and did affect overall survival; patients who received rituximab but not IFRT had a worse prognosis. Conclusions: The use of IFRT in patients with primary mediastinal B-cell lymphoma who achieved complete response remain as the best treatment available, even in patients that received rituximab during induction.

  2. [Pharmaceutical analysis and clinical efficacy of Kampo medicine, maoto, extract suppository against pediatric febrile symptoms].

    Science.gov (United States)

    Nishimura, Nobuhiro; Doi, Norio; Uemura, Tomochika; Taketani, Takeshi; Hayashi, George; Kasai, Takeshi; Kanai, Rie; Yamaguchi, Seiji; Iwamoto, Kikuo; Naora, Kohji

    2009-06-01

    A traditional Chinese herbal medicine, Kampo medicine, maoto, has been widely used in the treatment of febrile symptoms caused by viral infection. This herbal extract granule for oral use, however, is not well accepted by infants or young children due to its unpleasant taste and odor. Therefore, we prepared Kampo medicine, maoto, suppository and investigated the pharmaceutical and clinical efficacy of the suppository. Kampo medicine, maoto, granules were micro-pulverized and homogeneously dispersed into Hosco-H15 to prepare suppositories containing 0.25 to 1.0 g herbal extract by the conventional fusion method. Content of l-ephedrine, an index compound of Kampo medicine, maoto, in the extract granules and suppositories was determined by using a high performance liquid chromatographic method. Physicochemical experiments revealed that the suppository containing 0.5 g herbal extract had the most suitable melting point of 34 degrees C. Contents of l-ephedrine in the suppository were constant, 93-96% of those in the same amount of the extract granules in different three lots. Upper and lower portions of the suppository had the same content of l-ephedrine. The suppository maintained more than 95% of l-ephedrine content through 6 months at 4 degrees C, room temperature and 40 degrees C, although maldistribution of the extract constituent was observed after storage at 40 degrees C. The suppository was administered to 21 pediatric febrile patients at a dose of 1/3 to 2 full pieces depending on their body weight and physical status. Significant reduction (pchildren with viral febrile symptoms without any adverse effects.

  3. Clinical efficacy of local targeted chemotherapy for triple-negative breast cancer

    International Nuclear Information System (INIS)

    He, Jinsong; Wang, Xianming; Guan, Hong; Chen, Weicai; Wang, Ming; Wu, Huisheng; Wang, Zun; Zhou, Ruming; Qiu, Shuibo

    2011-01-01

    The aim of the study was to evaluate the clinical efficacy of superselective intra-arterial targeted neo-adjuvant chemotherapy in the treatment of estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and human epidermal growth factor receptor 2 (HER2)-negative (triple-negative) breast cancer. A total of 47 triple-negative breast cancer patients (29 at stage II, 13 at stage III and 5 at stage IV) were randomly assigned to two groups: targeted chemotherapy group (n=24) and control group (n=23). Patients in the targeted chemotherapy group received preoperative superselective intra-arterial chemotherapy with CEF regimen (C: cyclophosphamide [600 mg/m 2 ]; E: epirubicin [90 mg/m 2 ]; F: 5-fluorouracil [600 mg/m 2 ]), and those in the control group received routine neoadjuvant chemotherapy with CEF. The duration of the treatment, changes in lesions and the prognosis were determined. The average course of the treatment was 15 days in the targeted chemotherapy group which was significantly shorter than that in the control group (31 days) (P<0.01). The remission rate of lesions was 91.6% in the targeted chemotherapy group and 60.9% in the control group, respectively. Among these patients, 9 died within two years, including 2 (both at IV stage) in the targeted chemotherapy group and 7 (2 at stage II, 4 at stage III and 1 at stage IV) in the control group. As an neoadjuvant therapy, the superselective intra-arterial chemotherapy is effective for triple-negative breast cancer, with advantages of the short treatment course and favourable remission rates as well as prognoses

  4. CLINICAL EFFICACY OF GLYCOSAMINOGLYCANS IN PATIENTS WITH DIABETES MELLITUS AND ISCHEMIC HEART DISEASE

    Directory of Open Access Journals (Sweden)

    L. V. Kozlova

    2011-01-01

    Full Text Available Aim. To study sulodexide clinical efficacy in patients with type 2 diabetes mellitus (DM and ischemic heart disease (IHD in prevention of contrast induced nephropathy (CIN. Material and мethods. Patients with type 2 DM and IHD who undergone X-Ray contrast intervention. The patients were randomized into 2 groups: 56 patients of the main group were i/v administered sulodexide (Vessel Due F , “Alfa Wassermann”, Italy according to standard procedure; 56 patients of the control group were treated with unfractionated heparin. Results. The incidence of CIN in the main and control groups was, respectively , 16% and 42% (p<0.01. Reduction of microalbuminuria (MAU was found in 89.3% of the sulodexide group patients. MAU dynamics in patients of control group was not observed. There were no deteriorations in echocardiography characteristics in patients of both groups. The reduction in  low density cholesterol and triglyceride plasma levels was observed in the main group. Sulodexide induced a lengthening of the activated partial thromboplastin time (from 30±0.6 to 34±0.5 s, without altering fibrinogen level. There were no thrombotic and hemorrhagic complications of endovascular intervention in sulodexide group. No one case of thrombocytopenia was observed. Higher risk of CIN in patients without sulodexide treatment compared with this in sulodexide treated patients was associated with multiple lesions of coronary arteries, diuretic intake in periprocedural period, contrast agent dose, duration of hospitalization, seriousness of intervention. Conclusion. Sulodexide therapy in patients with 2 type DM and IHD undergone X-Ray contrast intervention prevents renal dysfunction, providing antiproteinuric effect and correcting lipid metabolism and coagulation system disturbances.

  5. Ruptured corpus luteal cyst: Prediction of clinical outcomes with CT

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Myoung Seok; Moon, Min Hoan; Woo, Hyun Sik; Sung, Chang Kyu; Jeon, Hye Won; Lee, Taek Sang [SMG-SNU Boramae Medical Center, Seoul National University College of Medicine, Seoul (Korea, Republic of)

    2017-08-01

    To evaluate the determinant pretreatment CT findings that can predict surgical intervention for patients suffering from corpus luteal cyst rupture with hemoperitoneum. From January 2009 to December 2014, a total of 106 female patients (mean age, 26.1 years; range, 17–44 years) who visited the emergency room of our institute for acute abdominal pain and were subsequently diagnosed with ruptured corpus luteal cyst with hemoperitoneum were included in the retrospective study. The analysis of CT findings included cyst size, cyst shape, sentinel clot sign, ring of fire sign, hemoperitoneum depth, active bleeding in portal phase and attenuation of hemoperitoneum. The comparison of CT findings between the surgery and conservative management groups was performed with the Mann-Whitney U test or chi-square test. Logistic regression analysis was used to determine significant CT findings in predicting surgical intervention for a ruptured cyst. Comparative analysis revealed that the presence of active bleeding and the hemoperitoneum depth were significantly different between the surgery and conservative management groups and were confirmed as significant CT findings for predicting surgery, with adjusted odds ratio (ORs) of 3.773 and 1.318, respectively (p < 0.01). On the receiver-operating characteristic curve analysis for hemoperitoneum depth, the optimal cut-off value was 5.8 cm with 73.7% sensitivity and 58.6% specificity (Az = 0.711, p = 0.004). In cases with a hemoperitoneum depth > 5.8 cm and concurrent active bleeding, the OR for surgery increased to 5.786. The presence of active bleeding and the hemoperitoneum depth on a pretreatment CT scan can be predictive warning signs of surgery for a patient with a ruptured corpus luteal cyst with hemoperitoneum.

  6. Somatic cell count distributions during lactation predict clinical mastitis

    NARCIS (Netherlands)

    Green, M.J.; Green, L.E.; Schukken, Y.H.; Bradley, A.J.; Peeler, E.J.; Barkema, H.W.; Haas, de Y.; Collis, V.J.; Medley, G.F.

    2004-01-01

    This research investigated somatic cell count (SCC) records during lactation, with the purpose of identifying distribution characteristics (mean and measures of variation) that were most closely associated with clinical mastitis. Three separate data sets were used, one containing quarter SCC (n =

  7. Predicting malaria in an highly endemic country using clinical and ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    Kate Zinszer

    evaluate statistical models that integrate environmental and clinical data to .... was to identify and assess forecasting methods used to forecast malaria, and ...... 3Children's Hospital Informatics Program at the Harvard-MIT Division of Health Sciences and ...... Sachs J, Malaney P. The economic and social burden of malaria.

  8. THE ROLE OF SELF-EFFICACY IN PREDICTING USE OF DISTANCE EDUCATION TOOLS AND LEARNING MANAGEMENT SYSTEMS

    Directory of Open Access Journals (Sweden)

    Ibrahim ARPACI

    2017-01-01

    Full Text Available This study aims to investigate the role of self-efficacy in predicting students’ use of distance education tools and learning management systems (LMSs. A total of 124 undergraduate students who enrolled in a course on Distance Education and selected using convenience sampling willingly participated in the study. The participants had little prior knowledge about distance education tools and LMSs. Therefore, they received instructions from the researcher over the course of a semester. The study proposed a research model based on the Technology Acceptance Model that has been widely used to predict user acceptance and use. Structural equation modelling was used to test the research model against the data collected through questionnaire surveys. Pretest-posttest results suggested that the students had significant learning by participating in the instruction. The results of the main analysis also suggested that self-efficacy positively affects perceived ease of use, while usefulness and ease of use perceptions positively affect attitudes toward using distance education tools and systems. Implications are provided along with limitations of the study discussed.

  9. Why Do I Feel More Confident? Bandura's Sources Predict Preservice Teachers' Latent Changes in Teacher Self-Efficacy

    Science.gov (United States)

    Pfitzner-Eden, Franziska

    2016-01-01

    Teacher self-efficacy (TSE) is associated with a multitude of positive outcomes for teachers and students. However, the development of TSE is an under-researched area. Bandura (1997) proposed four sources of self-efficacy: mastery experiences, vicarious experiences, verbal persuasion, and physiological and affective states. This study introduces a first instrument to assess the four sources for TSE in line with Bandura's conception. Gathering evidence of convergent validity, the contribution that each source made to the development of TSE during a practicum at a school was explored for two samples of German preservice teachers. The first sample (N = 359) were beginning preservice teachers who completed an observation practicum. The second sample (N = 395) were advanced preservice teachers who completed a teaching practicum. The source measure showed good reliability, construct validity, and convergent validity. Latent true change modeling was applied to explore how the sources predicted changes in TSE. Three different models were compared. As expected, results showed that TSE changes in both groups were significantly predicted by mastery experiences, with a stronger relationship in the advanced group. Further, the results indicated that mastery experiences were largely informed by the other three sources to varying degrees depending on the type of practicum. Implications for the practice of teacher education are discussed in light of the results. PMID:27807422

  10. Predicting efficacy of robot-aided rehabilitation in chronic stroke patients using an MRI-compatible robotic device.

    Science.gov (United States)

    Sergi, Fabrizio; Krebs, Hermano Igo; Groissier, Benjamin; Rykman, Avrielle; Guglielmelli, Eugenio; Volpe, Bruce T; Schaechter, Judith D

    2011-01-01

    We are investigating the neural correlates of motor recovery promoted by robot-mediated therapy in chronic stroke. This pilot study asked whether efficacy of robot-aided motor rehabilitation in chronic stroke could be predicted by a change in functional connectivity within the sensorimotor network in response to a bout of motor rehabilitation. To address this question, two stroke patients participated in a functional connectivity MRI study pre and post a 12-week robot-aided motor rehabilitation program. Functional connectivity was evaluated during three consecutive scans before the rehabilitation program: resting-state; point-to-point reaching movements executed by the paretic upper extremity (UE) using a newly developed MRI-compatible sensorized passive manipulandum; resting-state. A single resting-state scan was conducted after the rehabilitation program. Before the program, UE movement reduced functional connectivity between the ipsilesional and contralesional primary motor cortex. Reduced interhemispheric functional connectivity persisted during the second resting-state scan relative to the first and during the resting-state scan after the rehabilitation program. Greater reduction in interhemispheric functional connectivity during the resting-state was associated with greater gains in UE motor function induced by the 12-week robotic therapy program. These findings suggest that greater reduction in interhemispheric functional connectivity in response to a bout of motor rehabilitation may predict greater efficacy of the full rehabilitation program.

  11. Immunoprotective efficacy of Acinetobacter baumannii outer membrane protein, FilF, predicted in silico as a potential vaccine candidate

    Directory of Open Access Journals (Sweden)

    Ravinder eSingh

    2016-02-01

    Full Text Available Acinetobacter baumannii is emerging as a serious nosocomial pathogen with multidrug resistance that has made it difficult to cure and development of efficacious treatment against this pathogen is direly needed. This has led to investigate vaccine approach to prevent and treat A. baumannii infections. In this work, an outer membrane putative pilus assembly protein, FilF, was predicted as vaccine candidate by in silico analysis of A. baumannii proteome and was found to be conserved among the A. baumannii strains. It was cloned and expressed in E. coli BL21(DE3 and purified by Ni-NTA chromatography. Immunization with FilF generated high antibody titer (>64000 and provided 50% protection against a standardized lethal dose (10*8 CFU of A. baumannii in murine pneumonia model. FilF immunization reduced the bacterial load in lungs by 2 and 4 log cycles, 12 and 24 h post infection as compared to adjuvant control; reduced the levels of pro-inflammatory cytokines TNF-α, IL-6, IL-33, IFN-γ and IL-1β significantly and histology of lung tissue supported the data by showing considerably reduced damage and infiltration of neutrophils in lungs. These results demonstrate the in vivo validation of immunoprotective efficacy of a protein predicted as a vaccine candidate by in silico proteomic analysis and open the possibilities for exploration of a large array of uncharacterized proteins.

  12. Predicting reattendance at a high-risk breast cancer clinic.

    Science.gov (United States)

    Ormseth, Sarah R; Wellisch, David K; Aréchiga, Adam E; Draper, Taylor L

    2015-10-01

    The research about follow-up patterns of women attending high-risk breast-cancer clinics is sparse. This study sought to profile daughters of breast-cancer patients who are likely to return versus those unlikely to return for follow-up care in a high-risk clinic. Our investigation included 131 patients attending the UCLA Revlon Breast Center High Risk Clinic. Predictor variables included age, computed breast-cancer risk, participants' perceived personal risk, clinically significant depressive symptomatology (CES-D score ≥ 16), current level of anxiety (State-Trait Anxiety Inventory), and survival status of participants' mothers (survived or passed away from breast cancer). A greater likelihood of reattendance was associated with older age (adjusted odds ratio [AOR] = 1.07, p = 0.004), computed breast-cancer risk (AOR = 1.10, p = 0.017), absence of depressive symptomatology (AOR = 0.25, p = 0.009), past psychiatric diagnosis (AOR = 3.14, p = 0.029), and maternal loss to breast cancer (AOR = 2.59, p = 0.034). Also, an interaction was found between mother's survival and perceived risk (p = 0.019), such that reattendance was associated with higher perceived risk among participants whose mothers survived (AOR = 1.04, p = 0.002), but not those whose mothers died (AOR = 0.99, p = 0.685). Furthermore, a nonlinear inverted "U" relationship was observed between state anxiety and reattendance (p = 0.037); participants with moderate anxiety were more likely to reattend than those with low or high anxiety levels. Demographic, medical, and psychosocial factors were found to be independently associated with reattendance to a high-risk breast-cancer clinic. Explication of the profiles of women who may or may not reattend may serve to inform the development and implementation of interventions to increase the likelihood of follow-up care.

  13. Efficacy and safety at 24 weeks of daily clinical use of tofacitinib in patients with rheumatoid arthritis.

    Science.gov (United States)

    Iwamoto, Naoki; Tsuji, Sosuke; Takatani, Ayuko; Shimizu, Toshimasa; Fukui, Shoichi; Umeda, Masataka; Nishino, Ayako; Horai, Yoshiro; Koga, Tomohiro; Kawashiri, Shin-Ya; Aramaki, Toshiyuki; Ichinose, Kunihiro; Hirai, Yasuko; Tamai, Mami; Nakamura, Hideki; Terada, Kaoru; Origuchi, Tomoki; Eguchi, Katsumi; Ueki, Yukitaka; Kawakami, Atsushi

    2017-01-01

    We evaluated the efficacy and safety of tofacitinib in patients with rheumatoid arthritis (RA) in a real-world setting. Seventy consecutive patients, for whom tofacitinib was initiated between November 2013 and May 2016, were enrolled. All patients fulfilled the 2010 ACR/EULAR classification criteria for RA. All patients received 5 mg of tofacitinib twice daily and were followed for 24 weeks. Clinical disease activity indicated by disease activity score (DAS)28-ESR, the simplified disease activity index, and the clinical disease activity index as well as adverse events (AEs) were evaluated. Statistical analysis was performed to determine which baseline variables influenced the efficacy of tofacitinib at 24 weeks. Fifty-eight patients (82.9%) continued tofacitinib at 24 weeks. Clinical disease activity rapidly and significantly decreased, and this efficacy continued throughout the 24 weeks: i.e., DAS28-ESR decreased from 5.04 ± 1.33 at baseline to 3.83 ± 1.11 at 4 weeks and 3.53 ± 1.17 at 24 weeks (Ptofacitinib treatment. The efficacy of tofacitinib was not changed in patients without concomitant use of methotrexate (MTX) or patients whose treatment with tocilizumab (TCZ) failed. Multivariable logistic analysis showed that the number of biologic DMARDs (bDMARDs) previously used was independently associated with achievement of DAS-low disease activity. Our present study suggests that tofacitinib is effective in real-world settings even without concomitant MTX use or after switching from TCZ. Our results also suggest that its efficacy diminishes if started after use of multiple bDMARDs.

  14. Efficacy and safety at 24 weeks of daily clinical use of tofacitinib in patients with rheumatoid arthritis.

    Directory of Open Access Journals (Sweden)

    Naoki Iwamoto

    Full Text Available We evaluated the efficacy and safety of tofacitinib in patients with rheumatoid arthritis (RA in a real-world setting.Seventy consecutive patients, for whom tofacitinib was initiated between November 2013 and May 2016, were enrolled. All patients fulfilled the 2010 ACR/EULAR classification criteria for RA. All patients received 5 mg of tofacitinib twice daily and were followed for 24 weeks. Clinical disease activity indicated by disease activity score (DAS28-ESR, the simplified disease activity index, and the clinical disease activity index as well as adverse events (AEs were evaluated. Statistical analysis was performed to determine which baseline variables influenced the efficacy of tofacitinib at 24 weeks.Fifty-eight patients (82.9% continued tofacitinib at 24 weeks. Clinical disease activity rapidly and significantly decreased, and this efficacy continued throughout the 24 weeks: i.e., DAS28-ESR decreased from 5.04 ± 1.33 at baseline to 3.83 ± 1.11 at 4 weeks and 3.53 ± 1.17 at 24 weeks (P<0.0001, vs. baseline. 15 AEs including 5 herpes zoster infection occurred during tofacitinib treatment. The efficacy of tofacitinib was not changed in patients without concomitant use of methotrexate (MTX or patients whose treatment with tocilizumab (TCZ failed. Multivariable logistic analysis showed that the number of biologic DMARDs (bDMARDs previously used was independently associated with achievement of DAS-low disease activity.Our present study suggests that tofacitinib is effective in real-world settings even without concomitant MTX use or after switching from TCZ. Our results also suggest that its efficacy diminishes if started after use of multiple bDMARDs.

  15. Personalizing oncology treatments by predicting drug efficacy, side-effects, and improved therapy: mathematics, statistics, and their integration.

    Science.gov (United States)

    Agur, Zvia; Elishmereni, Moran; Kheifetz, Yuri

    2014-01-01

    Despite its great promise, personalized oncology still faces many hurdles, and it is increasingly clear that targeted drugs and molecular biomarkers alone yield only modest clinical benefit. One reason is the complex relationships between biomarkers and the patient's response to drugs, obscuring the true weight of the biomarkers in the overall patient's response. This complexity can be disentangled by computational models that integrate the effects of personal biomarkers into a simulator of drug-patient dynamic interactions, for predicting the clinical outcomes. Several computational tools have been developed for personalized oncology, notably evidence-based tools for simulating pharmacokinetics, Bayesian-estimated tools for predicting survival, etc. We describe representative statistical and mathematical tools, and discuss their merits, shortcomings and preliminary clinical validation attesting to their potential. Yet, the individualization power of mathematical models alone, or statistical models alone, is limited. More accurate and versatile personalization tools can be constructed by a new application of the statistical/mathematical nonlinear mixed effects modeling (NLMEM) approach, which until recently has been used only in drug development. Using these advanced tools, clinical data from patient populations can be integrated with mechanistic models of disease and physiology, for generating personal mathematical models. Upon a more substantial validation in the clinic, this approach will hopefully be applied in personalized clinical trials, P-trials, hence aiding the establishment of personalized medicine within the main stream of clinical oncology. © 2014 Wiley Periodicals, Inc.

  16. Schizophrenia and the efficacy of qEEG-guided neurofeedback treatment: a clinical case series.

    Science.gov (United States)

    Surmeli, Tanju; Ertem, Ayben; Eralp, Emin; Kos, Ismet H

    2012-04-01

    Schizophrenia is sometimes considered one of the most devastating of mental illnesses because its onset is early in a patient's life and its symptoms can be destructive to the patient, the family, and friends. Schizophrenia affects 1 in 100 people at some point during their lives, and while there is no cure, it is treatable with antipsychotic medications. According to the Clinical Antipsychotic Trials for Interventions Effectiveness (CATIE), about 74% of the patients who have discontinued the first medication prescribed within a year will have a relapse afterward. This shows an enormous need for developing better treatment methods and better ways to manage the disease, since current therapies do not have sufficient impact on negative symptoms, cognitive dysfunction, and compliance to treatment. In this clinical case series, we investigate the efficacy of quantitative electroencephalography (qEEG)-guided neurofeedback (NF) treatment in this population, and whether this method has an effect on concurrent medical treatment and on the patients. Fifty-one participants (25 males and 26 females) ranging from 17 to 54 years of age (mean: 28.82 years and SD: 7.94 years) were included. Signed consent was received from all patients. Most of the participants were previously diagnosed with chronic schizophrenia, and their symptoms did not improve with medication. All 51 patients were evaluated using qEEG, which was recorded at baseline and following treatment. Before recording the qEEG, participants were washed out for up to 7 half-lives of the medication. After Food and Drug Administration (FDA)-approved Nx-Link Neurometric analysis, qEEGs suggested a diagnosis of chronic schizophrenia for all participants. This was consistent with the clinical judgment of the authors. The participants' symptoms were assessed by means of the Positive and Negative Syndrome Scale (PANSS). Besides the PANSS, 33 out of 51 participants were also evaluated by the Minnesota Multiphasic Personality

  17. Clinical Efficacy Comparison of Saccharomyces Boulardii and Lactic Acid as Probiotics in Acute Pediatric Diarrhea.

    Science.gov (United States)

    Asmat, Shakila; Shaukat, Fouzia; Asmat, Raheela; Bakhat, Hafiz Faiq Siddique Gul; Asmat, Tauseef M

    2018-03-01

    To compare the efficacy of Saccharomyces boulardii and lactic acid producing probiotics in addition to usual treatment regimen to cure diarrhea among children (6 months to 5 years of age). Randomized controlled trial. Department of Pediatrics, Sheikh Zayed Hospital, Lahore, from February to July 2015. Children suffering from acute diarrhea were orally administered Saccharomyces boulardii and lactic acid producing probiotics for 5 days. The efficacy of administered probiotics was monitored. Patients were given Saccharomyces boulardii and lactic acid producing probiotics randomly to remove the bias. Two hundred patients randomly selected for trials; out of which, 100 were treated with Saccharomyces boulardii while the other 100 were supplemented with lactic acid concomitantly along with conventional diarrhea treatment. Results indicated that Saccharomyces boulardii treatment group has significantly higher efficacy rate (45%) compared to lactic acid producing probiotics (26%). This study concluded that Saccharomyces boulardii has a better efficacy compared to lactic acid and may be adopted as a probiotic of choice.

  18. Safety, Efficacy, Predictability and Stability Indices of Photorefractive Keratectomy for Correction of Myopic Astigmatism with Plano-Scan and Tissue-Saving Algorithms

    Directory of Open Access Journals (Sweden)

    Mehrdad Mohammadpour

    2013-10-01

    Full Text Available Purpose: To assess the safety, efficacy and predictability of photorefractive keratectomy (PRK [Tissue-saving (TS versus Plano-scan (PS ablation algorithms] of Technolas 217z excimer laser for correction of myopic astigmatismMethods: In this retrospective study one hundred and seventy eyes of 85 patients (107 eyes (62.9% with PS and 63 eyes (37.1% with TS algorithm were included. TS algorithm was applied for those with central corneal thickness less than 500 µm or estimated residual stromal thickness less than 420 µm. Mitomycin C (MMC was applied for 120 eyes (70.6%; in case of an ablation depth more than 60 μm and/or astigmatic correction more than one diopter (D. Mean sphere, cylinder, spherical equivalent (SE refraction, uncorrected visual acuity (UCVA, best corrected visual acuity (BCVA were measured preoperatively, and 4 weeks,12 weeks and 24 weeks postoperatively.Results: One, three and six months postoperatively, 60%, 92.9%, 97.5% of eyes had UCVA of 20/20 or better, respectively. Mean preoperative and 1, 3, 6 months postoperative SE were -3.48±1.28 D (-1.00 to -8.75, -0.08±0.62D, -0.02±0.57 and -0.004± 0.29, respectively. And also, 87.6%, 94.1% and 100% were within ±1.0 D of emmetropia and 68.2, 75.3, 95% were within ±0.5 of emmetropia. The safety and efficacy indices were 0.99 and 0.99 at 12 weeks and 1.009 and 0.99 at 24 weeks, respectively. There was no clinically or statistically significant difference between the outcomes of PS or TS algorithms or between those with or without MMC in either group in terms of safety, efficacy, predictability or stability. Dividing the eyes with subjective SE≤4 D and SE≥4 D postoperatively, there was no significant difference between the predictability of the two groups. There was no intra- or postoperative complication.Conclusion: Outcomes of PRK for correction of myopic astigmatism showed great promise with both PS and TS algorithms.

  19. Violence risk prediction. Clinical and actuarial measures and the role of the Psychopathy Checklist.

    Science.gov (United States)

    Dolan, M; Doyle, M

    2000-10-01

    Violence risk prediction is a priority issue for clinicians working with mentally disordered offenders. To review the current status of violence risk prediction research. Literature search (Medline). Key words: violence, risk prediction, mental disorder. Systematic/structured risk assessment approaches may enhance the accuracy of clinical prediction of violent outcomes. Data on the predictive validity of available clinical risk assessment tools are based largely on American and North American studies and further validation is required in British samples. The Psychopathy Checklist appears to be a key predictor of violent recidivism in a variety of settings. Violence risk prediction is an inexact science and as such will continue to provoke debate. Clinicians clearly need to be able to demonstrate the rationale behind their decisions on violence risk and much can be learned from recent developments in research on violence risk prediction.

  20. Determination of Efficacy of Reflexology in Managing Patients with Diabetic Neuropathy: A Randomized Controlled Clinical Trial

    OpenAIRE

    Dalal, Krishna; Maran, V. Bharathi; Pandey, Ravindra M.; Tripathi, Manjari

    2014-01-01

    Background. The restricted usage of existing pharmacological methods which do not seem to provide the treatment of diabetic neuropathy may lead to exploring the efficacy of a complementary therapy. In this context, this paper was devoted to evaluate the efficacy of foot reflexology. This health science works on the hypothesis that the dysfunctional states of body parts could be identified by observing certain skin features and be rectified by stimulating certain specific areas mapped on feet....

  1. A proposed framework for evaluating and comparing efficacy estimates in clinical trials of new rotavirus vaccines.

    Science.gov (United States)

    Neuzil, Kathleen M; Zaman, K; Victor, John C

    2014-08-11

    Oral rotavirus vaccines have yielded different point estimates of efficacy when tested in different populations. While population and environmental factors may account for these differences, study design characteristics should also be considered. We review the study design elements of rotavirus vaccine trials that may affect point estimates of efficacy, and propose a framework for evaluating new rotavirus vaccines. Copyright © 2014. Published by Elsevier Ltd.

  2. A clinical prediction rule for detecting major depressive disorder in primary care : the PREDICT-NL study

    NARCIS (Netherlands)

    Zuithoff, Nicolaas P A; Vergouwe, Yvonne; King, Michael; Nazareth, Irwin; Hak, Eelko; Moons, Karel G M; Geerlings, Mirjam I

    BACKGROUND: Major depressive disorder often remains unrecognized in primary care. OBJECTIVE: Development of a clinical prediction rule using easily obtainable predictors for major depressive disorder in primary care patients. METHODS: A total of 1046 subjects, aged 18-65 years, were included from

  3. Enhancing predicted efficacy of tumor treating fields therapy of glioblastoma using targeted surgical craniectomy: A computer modeling study

    DEFF Research Database (Denmark)

    Korshoej, Anders Rosendal; Saturnino, Guilherme Bicalho; Rasmussen, Line Kirkegaard

    2016-01-01

    the potential of the intervention to improve the clinical efficacy of TTFields therapy of brain cancer. Methods: We used finite element analysis to calculate the electrical field distribution in realistic head models based on MRI data from two patients: One with left cortical/subcortical glioblastoma and one......Objective: The present work proposes a new clinical approach to TTFields therapy of glioblastoma. The approach combines targeted surgical skull removal (craniectomy) with TTFields therapy to enhance the induced electrical field in the underlying tumor tissue. Using computer simulations, we explore...... with deeply seated right thalamic anaplastic astrocytoma. Field strength was assessed in the tumor regions before and after virtual removal of bone areas of varying shape and size (10 to 100 mm) immediately above the tumor. Field strength was evaluated before and after tumor resection to assess realistic...

  4. Efficacy of a novel, biologically active food supplement in type 2 diabetes mellitus: a patient-blinded, prospective, clinical trial

    OpenAIRE

    Podichetty, Vinod; Weshler,; Schlosser,

    2011-01-01

    Vinod K Podichetty1, Mishel Weshler2, John Schlosser31Research Practice Partners Inc., Miramar, Florida, USA; 2Weshler and Weshler Clinic, Nazareth Illit, Israel; 3Rockland Endocrine and Diabetic Services, Suffern, New York, USAAbstract: Despite significant achievements in the prevention and management of diabetes, its prevalence has risen exponentially, creating a paramount need for alternative therapies. The purpose of the study was to investigate the safety and efficacy of two novel, biolo...

  5. Methodology and lessons-learned from the efficacy clinical trial of the pentavalent rotavirus vaccine in Bangladesh.

    Science.gov (United States)

    Zaman, K; Yunus, M; El Arifeen, Shams; Azim, Tasnim; Faruque, A S G; Huq, Ehsanul; Hossain, Ilias; Luby, Stephen P; Victor, John C; Dallas, Michael J; Lewis, Kristen D C; Rivers, Stephen B; Steele, A Duncan; Neuzil, Kathleen M; Ciarlet, Max; Sack, David A

    2012-04-27

    An efficacy clinical trial with pentavalent rotavirus vaccine (PRV), RotaTeq(®), was conducted at Matlab field site of ICDDR,B, Bangladesh from March 2007 to March 2009. The methodology, including operation logistics, and lessons-learned are described in this report. Vaccination was organized at 41 fixed-site clinics twice/month. A total of 1136 infants were randomized 1:1 to receive 3 doses of PRV/placebo at approximately 6-, 10-, and 14-weeks of age with routine vaccines of the Expanded Programme on Immunization (EPI) schedule. Twelve field-workers routinely visited study participants for safety and efficacy follow-up. The study was conducted following good clinical practices and maintaining cold-chain requirements. There were no temperature deviations of clinical vaccine supplies. Data entry was done using the source documents to a central database developed by the sponsor which was linked to web. Among enrolled infants, 1128 (99.3%) received 3 doses of PRV/placebo and efficacy follow-up was conducted for a median of 554 days. For the evaluation of immunogenicity, blood samples were collected from 150 participants predose 1 and from 147 (98%) of the same participants post dose 3. Stool samples were collected from 778 (99.9%) acute gastroenteritis episodes among children who reported to diarrhoea treatment centres. Thirty-nine serious adverse events, including 6 deaths, occurred among study participants. The efficacy of PRV against severe rotavirus gastroenteritis was 42.7% through the entire follow-up period; serum anti-rotavirus IgA response was 78.1%. Inclement weather, difficult transportation, and movement of study participants were some of the challenges identified. This is the first vaccine trial in rural Bangladesh with online data entry. The study was well accepted in the community and was completed successfully. Copyright © 2011 Elsevier Ltd. All rights reserved.

  6. Automated interpretable computational biology in the clinic: a framework to predict disease severity and stratify patients from clinical data

    Directory of Open Access Journals (Sweden)

    Soumya Banerjee

    2017-10-01

    Full Text Available We outline an automated computational and machine learning framework that predicts disease severity and stratifies patients. We apply our framework to available clinical data. Our algorithm automatically generates insights and predicts disease severity with minimal operator intervention. The computational framework presented here can be used to stratify patients, predict disease severity and propose novel biomarkers for disease. Insights from machine learning algorithms coupled with clinical data may help guide therapy, personalize treatment and help clinicians understand the change in disease over time. Computational techniques like these can be used in translational medicine in close collaboration with clinicians and healthcare providers. Our models are also interpretable, allowing clinicians with minimal machine learning experience to engage in model building. This work is a step towards automated machine learning in the clinic.

  7. A biomarker profile for predicting efficacy of cisplatin-vinorelbine therapy in malignant pleural mesothelioma

    DEFF Research Database (Denmark)

    Zimling, Zarah Glad; Sørensen, Jens Benn; Gerds, Thomas Alexander

    2012-01-01

    Malignant pleural mesothelioma (MPM) has a dismal prognosis. Treatment results may be improved by biomarker-directed therapy. We investigated the baseline expression and impact on outcome of predictive biomarkers ERCC1, BRCA1, and class III β-tubulin in a cohort of MPM patients treated with cispl......Malignant pleural mesothelioma (MPM) has a dismal prognosis. Treatment results may be improved by biomarker-directed therapy. We investigated the baseline expression and impact on outcome of predictive biomarkers ERCC1, BRCA1, and class III β-tubulin in a cohort of MPM patients treated...

  8. Predictive efficacy of low burden EGFR mutation detected by next-generation sequencing on response to EGFR tyrosine kinase inhibitors in non-small-cell lung carcinoma.

    Directory of Open Access Journals (Sweden)

    Hye Sook Kim

    Full Text Available Direct sequencing remains the most widely used method for the detection of epidermal growth factor receptor (EGFR mutations in lung cancer; however, its relatively low sensitivity limits its clinical use. The objective of this study was to investigate the sensitivity of detecting an epidermal growth factor receptor (EGFR mutation from peptide nucleic acid-locked nucleic acid polymerase chain reaction (PNA-LNA PCR clamp and Ion Torrent Personal Genome Machine (PGM techniques compared to that by direct sequencing. Furthermore, the predictive efficacy of EGFR mutations detected by PNA-LNA PCR clamp was evaluated. EGFR mutational status was assessed by direct sequencing, PNA-LNA PCR clamp, and Ion Torrent PGM in 57 patients with non-small cell lung cancer (NSCLC. We evaluated the predictive efficacy of PNA-LNA PCR clamp on the EGFR-TKI treatment in 36 patients with advanced NSCLC retrospectively. Compared to direct sequencing (16/57, 28.1%, PNA-LNA PCR clamp (27/57, 47.4% and Ion Torrent PGM (26/57, 45.6% detected more EGFR mutations. EGFR mutant patients had significantly longer progressive free survival (14.31 vs. 21.61 months, P = 0.003 than that of EGFR wild patients when tested with PNA-LNA PCR clamp. However, no difference in response rate to EGFR TKIs (75.0% vs. 82.4%, P = 0.195 or overall survival (34.39 vs. 44.10 months, P = 0.422 was observed between the EGFR mutations by direct sequencing or PNA-LNA PCR clamp. Our results demonstrate firstly that patients with EGFR mutations were detected more frequently by PNA-LNA PCR clamp and Ion Torrent PGM than those by direct sequencing. EGFR mutations detected by PNA-LNA PCR clamp may be as a predicative factor for EGFR TKI response in patients with NSCLC.

  9. Efficacy of specific gravity as a tool for prediction of biodiesel-petroleum diesel blend ratio

    Science.gov (United States)

    Prediction of volumetric biodiesel/petrodiesel blend ratio (VBD) from specific gravity (SG) data was the subject of the current investigation. Fatty acid methyl esters obtained from soybean, palm, and rapeseed oils along with chicken fat (SME-1, SME-2, PME, RME, and CFME) were blended (0 to 20 volum...

  10. Predicting South Korean University Students' Happiness through Social Support and Efficacy Beliefs

    Science.gov (United States)

    Lee, Diane Sookyoung; Padilla, Amado M.

    2016-01-01

    This study investigated the adversity and coping experiences of 198 South Korean university students and takes a cultural lens in understanding how social and individual factors shape their happiness. Hierarchical linear regression analyses suggest that Korean students' perceptions of social support significantly predicted their happiness,…

  11. Locus heterogeneity for Waardenburg syndrome is predictive of clinical subtypes.

    Science.gov (United States)

    Farrer, L A; Arnos, K S; Asher, J H; Baldwin, C T; Diehl, S R; Friedman, T B; Greenberg, J; Grundfast, K M; Hoth, C; Lalwani, A K

    1994-10-01

    Waardenburg syndrome (WS) is a dominantly inherited and clinically variable syndrome of deafness, pigmentary changes, and distinctive facial features. Clinically, WS type I (WS1) is differentiated from WS type II (WS2) by the high frequency of dystopia canthorum in the family. In some families, WS is caused by mutations in the PAX3 gene on chromosome 2q. We have typed microsatellite markers within and flanking PAX3 in 41 WS1 kindreds and 26 WS2 kindreds in order to estimate the proportion of families with probable mutations in PAX3 and to study the relationship between phenotypic and genotypic heterogeneity. Evaluation of heterogeneity in location scores obtained by multilocus analysis indicated that WS is linked to PAX3 in 60% of all WS families and in 100% of WS1 families. None of the WS2 families were linked. In those families in which equivocal lod scores (between -2 and +1) were found, PAX3 mutations have been identified in 5 of the 15 WS1 families but in none of the 4 WS2 families. Although preliminary studies do not suggest any association between the phenotype and the molecular pathology in 20 families with known PAX3 mutations and in four patients with chromosomal abnormalities in the vicinity of PAX3, the presence of dystopia in multiple family members is a reliable indicator for identifying families likely to have a defect in PAX3.

  12. Efficacy of a grapefruit extract on head lice: a clinical trial.

    Science.gov (United States)

    Abdel-Ghaffar, Fathy; Semmler, Margit; Al-Rasheid, Khaled; Klimpel, Sven; Mehlhorn, Heinz

    2010-01-01

    Twenty children aging 2-9 years old--four boys with short hair and 16 girls with long hair--were included in a clinical test on the efficacy of a product against head lice (Pediculus humanus capitis). Their hair were exposed to Licatack, which is a recently developed new anti-louse medicinal product containing extracts of grapefruits besides high quality shampoo components. Prior to this field trial, the product Licatack was tested dermatologically to be skin safe receiving the grade "very good". The children's mothers combed the kids prior to the start of the test in order to confirm that they were all lice-infested. The obtained lice were used for in vitro tests. All children were heavily infested. After combing and preservation of the living lice, the hair was wet with tap water. Then, 50 ml of the Licatack shampoo was placed onto the top of each child's head. Then, the mothers distributed the rather fluid product all over the hair thoroughly from their base at the skin until the free end. During this process, a type of massage, the product became foamy and it was easily recognized where the product covered the hair, thus, avoiding untreated spots. The hair of half of the treated children were washed with tap water after 10 min of exposition; while in the other half of the children, the exposition period was prolonged to 20 min before washing. When combing the kids with a metal louse comb after the washing, the lice were found immobile and they did not recover during the following observation period of 4 h. Only two lice from the group with an exposition time of only 10 min showed some slight leg movements after they had been combed off, but they died within the next 2 h. Thus, this new anti-louse medicinal product has a very quick and efficient activity besides its advantages of being non-inflammable, skin safe, and nice smelling. None of the kids claimed any burning at the skin or other side effects, although the skin showed, prior to treatment, lots of scars

  13. [Clinical efficacy and safety of uterine artery chemoembolization in abnormal placental implantation complicated with postpartum hemorrhage].

    Science.gov (United States)

    Chen, Yao-ting; Xu, Lin-feng; Sun, Hong-liang; Li, Hui-qing; Hu, Ren-mei; Tan, Qi-yin

    2010-04-01

    To investigate the safety and clinical efficacy of uterime artery chemoembolization in postpartum hemorrhage (PPH) caused by abnormal placental implantation. Between December 2006 and September 2009, there were 23 cases of abnormal placental implantation with PPH in our hospital, among which 9 presented with continuous small amount of vaginal bleeding and 14 with acute excessive bleeding. The average bleeding time was (8+/-6) d and the mean blood loss was (980+/-660) ml. Abnormal placental implantation was confirmed by color Doppler ultrasound (CD-US) in all cases, the internal iliac artery angiography was performed to identify the uterine artery and bilateral uterine artery chemoembolization (UACE) with methotrexate (MTX) and gelfoam particles to the distal end of uterine artery was conducted after. CD-US rechecked all patients within 48 h after UACE and those patients with blurred margins between placenta and uterus and abnormal blood flow (>1 cmx1 cm) received ultrasonic-guided per vagina MTX multipoint injections. All cases were followed up for 3-26 months (average 12 months) to observe vaginal bleeding, placenta tissue discharge, serum human chorionic gonadotropin (hCG), uterine involution, menses, and side-effects or complications. (1) Curative effect: These 23 cases underwent 24 procedures of UACE successfully and vaginal bleeding ceased at an average of (3.5+/-1.3) min after UACE. Reduced blood flow in the placental implantation area was detected under CD-US after UACE. Among the 23 patients, wterine curettage was required in 16 cases due to retained placenta tissues with the mean blood loss of (40+/-28) ml during the operation, 2 underwent subtotal hysterectomy and confirmed to be placenta percreta by pathology examination, and placenta tissues were spontaneously discharged completely in 5 cases. Totally, 91% of the patients (21/23) reserved their uterus. (2) FOLLOW-UP: the serum hCG reduced to normal within 1-13 d after the placenta tissue were evacuated

  14. Surgical and clinical efficacy of sacroiliac joint fusion: a systematic review of the literature.

    Science.gov (United States)

    Zaidi, Hasan A; Montoure, Andrew J; Dickman, Curtis A

    2015-07-01

    The sacroiliac joint (SIJ) and surgical intervention for treating SIJ pain or dysfunction has been a topic of much debate in recent years. There has been a resurgence in the implication of this joint as the pain generator for many patients experiencing low-back pain, and new surgical methods are gaining popularity within both the orthopedic and neurosurgical fields. There is no universally accepted gold standard for diagnosing or surgically treating SIJ pain. The authors systematically reviewed studies on SIJ fusion in the neurosurgical and orthopedic literature to investigate whether sufficient evidence exists to support its use. A literature search was performed using MEDLINE, Google Scholar, and OvidSP-Wolters Kluwer Health for all articles regarding SIJ fusion published from 2000 to 2014. Original, peer-reviewed, prospective or retrospective scientific papers with at least 2 patients were included in the study. Exclusion criteria included follow-up shorter than 1-year, nonsurgical treatment, inadequate clinical data as determined by 2 independent reviewers, non-English manuscripts, and nonhuman subjects. A total of 16 peer-reviewed journal articles met the inclusion criteria: 5 consecutive case series, 8 retrospective studies, and 3 prospective cohort studies. A total of 430 patients were included, of whom 131 underwent open surgery and 299 underwent minimally invasive surgery (MIS) for SIJ fusion. The mean duration of follow-up was 60 months for open surgery and 21 months for MIS. SIJ degeneration/arthrosis was the most common pathology among patients undergoing surgical intervention (present in 257 patients [59.8%]), followed by SIJ dysfunction (79 [18.4%]), postpartum instability (31 [7.2%]), posttraumatic (28 [6.5%]), idiopathic (25 [5.8%]), pathological fractures (6 [1.4%]), and HLA-B27+/rheumatoid arthritis (4 [0.9%]). Radiographically confirmed fusion rates were 20%-90% for open surgery and 13%-100% for MIS. Rates of excellent satisfaction, determined by

  15. Significance of tissue edema patterns following angioocclusion: Predictability of therapeutic efficacy with MR imaging

    International Nuclear Information System (INIS)

    Kauffman, G.W.; Richter, G.M.; Roeren, T.; Friedburg, H.G.; Wenz, W.

    1987-01-01

    In an experimental and clinical study the authors assessed the potential of MR imaging to demonstrate tissue edema after central and capillary embolization. Thirty Wistar rats underwent either central or capillary Ethibloc embolization. MR imaging revealed that tissue edema after capillary embolization started sooner, laster longer, was more intense, and was much more homogeneous than after central occlusion. In addition, total necrosis was found microscopically only after capillary embolization. In six clinical cases of renal tumor embolization with Ethibloc, MR imaging similarly demonstrated a rapidly developing and homogeneous edema that decreased when tumor shrinkage was found. In all these patients complete tumor necrosis was proved with CT

  16. Ethics and epistemology of accurate prediction in clinical research.

    Science.gov (United States)

    Hey, Spencer Phillips

    2015-07-01

    All major research ethics policies assert that the ethical review of clinical trial protocols should include a systematic assessment of risks and benefits. But despite this policy, protocols do not typically contain explicit probability statements about the likely risks or benefits involved in the proposed research. In this essay, I articulate a range of ethical and epistemic advantages that explicit forecasting would offer to the health research enterprise. I then consider how some particular confidence levels may come into conflict with the principles of ethical research. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  17. Comparative prediction of nonepileptic events using MMPI-2 clinical scales, Harris Lingoes subscales, and restructured clinical scales.

    Science.gov (United States)

    Yamout, Karim Z; Heinrichs, Robin J; Baade, Lyle E; Soetaert, Dana K; Liow, Kore K

    2017-03-01

    The Minnesota Multiphasic Personality Inventory-2 (MMPI-2) is a psychological testing tool used to measure psychological and personality constructs. The MMPI-2 has proven helpful in identifying individuals with nonepileptic events/nonepileptic seizures. However, the MMPI-2 has had some updates that enhanced its original scales. The aim of this article was to test the utility of updated MMPI-2 scales in predicting the likelihood of non-epileptic seizures in individuals admitted to an EEG video monitoring unit. We compared sensitivity, specificity, and likelihood ratios of traditional MMPI-2 Clinical Scales against more homogenous MMPI-2 Harris-Lingoes subscales and the newer Restructured Clinical (RC) scales. Our results showed that the Restructured Scales did not show significant improvement over the original Clinical scales. However, one Harris-Lingoes subscale (HL4 of Clinical Scale 3) did show improved predictive utility over the original Clinical scales as well as over the newer Restructured Clinical scales. Our study suggests that the predictive utility of the MMPI-2 can be improved using already existing scales. This is particularly useful for those practitioners who are not invested in switching over to the newly developed MMPI-2 Restructured Form (MMPI-2 RF). Copyright © 2016 Elsevier Inc. All rights reserved.

  18. Development of a rotavirus vaccine: clinical safety, immunogenicity, and efficacy of the pentavalent rotavirus vaccine, RotaTeq.

    Science.gov (United States)

    Ciarlet, Max; Schödel, Florian

    2009-12-30

    Initial approaches for rotavirus vaccines were based on the classical "Jennerian" approach and utilized simian and bovine rotavirus strains, which provided cross-protection against human rotavirus strains but did not cause illness in infants and young children because of their species-specific tropism. The demonstrated efficacy of these vaccines was not consistent across studies. Thus, human-animal reassortants containing an animal rotavirus backbone with human rotavirus surface G and/or P proteins were developed, which demonstrated more consistent efficacy than that observed with the non-reassortant rotavirus strains. The pentavalent rotavirus vaccine, RotaTeq, contains 5 human-bovine reassortant rotaviruses consisting of a bovine (WC3) backbone with human rotavirus surface proteins representative of the most common G (G1, G2, G3, G4) or P (P1A[8]) types worldwide. The present review focuses on the development of the pentavalent rotavirus vaccine RotaTeq. Results of a large-scale Phase III clinical study showed that three doses of RotaTeq were immunogenic, efficacious, and well tolerated with no increased clinical risk of intussusception. RotaTeq was efficacious against rotavirus gastroenteritis of any severity (74%) and severe disease (98-100%), using a validated clinical scoring system. Reductions in rotavirus-associated hospitalizations and emergency department (ED) visits, for up to 2 years post-vaccination, were 95% in Europe, 97% in the United States, and 90% in the Latin American/Caribbean regions. RotaTeq was recently shown to be up to 100% effective in routine use in the US in reducing hospitalizations and ED visits and 96% effective in reducing physician visits. Additional studies in 8 different locations in the US have shown 85-95% reduction in rotavirus-associated hospitalizations and/or ED visits in the first 2-2.5 years of routine use.

  19. Clinical efficacy and safety of polyethylene glycol 3350 versus liquid paraffin in the treatment of pediatric functional constipation.

    Science.gov (United States)

    Rafati, Mr; Karami, H; Salehifar, E; Karimzadeh, A

    2011-01-01

    Functional constipation is prevalent in children. Recently polyethylene glycol has been introduced as an effective and safe drug to treat chronic constipation. There are only a few clinical trials on comparison of PEG and liquid paraffin in childhood constipation. The purpose of this study was to evaluate clinical efficacy and safety of PEG 3350 solution and liquid paraffin in the treatment of children with functional constipation in Sari Toba clinic during the period of 2008-2009. Children with a history of functional constipation were subjects of this study. One hundred and sixty children of 2-12 years old with functional constipation were randomized in two PEG and paraffin treatment groups. Patients received either 1.0-1.5 g/kg/day PEG 3350 or 1.0-1.5 ml/kg/day liquid paraffin for 4 months. Clinical efficacy was evaluated by stool and encopresis frequency/week and overall treatment success rate was compared in two groups. Compared with the baseline, defecation frequency/ week increased significantly and encopresis frequency meaningfully decreased in two groups during the period of the study. Patients using PEG 3350 had more success rate (mean: 95.3%±3.7) compared with the patients in paraffin group (mean: 87.2%±7.1) (p=0.087). Administration of PEG 3350 were associated with less adverse events than liquid paraffin. In conclusion in treatment of pediatric functional constipation, regarding clinical efficacy and safety, PEG 3350 were at least as effective as liquid paraffin and but less adverse drug events.

  20. Clinical efficacy and safety of polyethylene glycol 3350 versus liquid paraffin in the treatment of pediatric functional constipation

    Directory of Open Access Journals (Sweden)

    E Salehifar

    2011-05-01

    Full Text Available "nBackground and the purpose of the study: Functional constipation is prevalent in children. Recently has been introduced as an effective and safe drug to treat chronic constipation. There are only a few clinical trials on comparison of PEG and liquid paraffin in childhood constipation. The purpose of this study was to evaluate clinical efficacy and safety of PEG 3350 solution and liquid paraffin in the treatment of children with functional constipation in Sari Toba clinic during the period of 2008-2009. "nMethods: Children with a history of functional constipation were subjects of this study. One hundred and sixty children of 2-12 years old with functional constipation were randomized in two PEG and paraffin treatment groups. Patients received either 1.0-1.5 g/kg/day PEG 3350 or 1.0-1.5 ml/kg/day liquid paraffin for 4 months. Clinical efficacy was evaluated by stool and encopresis frequency/week and overall treatment success rate was compared in two groups. "nResults and major conclusion: Compared with the baseline, defecation frequency/ week increased significantly and encopresis frequency meaningfully decreased in two groups during the period of the study. Patients using PEG 3350 had more success rate (mean: 95.3%±3.7 compared with the patients in paraffin group (mean: 87.2%±7.1 (p=0.087. Administration of PEG 3350 was associated with less adverse events than liquid paraffin. In conclusion in treatment of pediatric functional constipation , regarding clinical efficacy and safety, PEG 3350 were at least as effective as liquid paraffin and but less adverse drug events.

  1. Clinical efficacy and safety of polyethylene glycol 3350 versus liquid paraffin in the treatment of pediatric functional constipation

    Science.gov (United States)

    Rafati, MR.; Karami, H.; Salehifar, E.; Karimzadeh, A.

    2011-01-01

    Background and the purpose of the study Functional constipation is prevalent in children. Recently polyethylene glycol has been introduced as an effective and safe drug to treat chronic constipation. There are only a few clinical trials on comparison of PEG and liquid paraffin in childhood constipation. The purpose of this study was to evaluate clinical efficacy and safety of PEG 3350 solution and liquid paraffin in the treatment of children with functional constipation in Sari Toba clinic during the period of 2008–2009. Methods Children with a history of functional constipation were subjects of this study. One hundred and sixty children of 2–12 years old with functional constipation were randomized in two PEG and paraffin treatment groups. Patients received either 1.0–1.5 g/kg/day PEG 3350 or 1.0–1.5 ml/kg/day liquid paraffin for 4 months. Clinical efficacy was evaluated by stool and encopresis frequency/week and overall treatment success rate was compared in two groups. Results and major conclusion Compared with the baseline, defecation frequency/ week increased significantly and encopresis frequency meaningfully decreased in two groups during the period of the study. Patients using PEG 3350 had more success rate (mean: 95.3%±3.7) compared with the patients in paraffin group (mean: 87.2%±7.1) (p=0.087). Administration of PEG 3350 were associated with less adverse events than liquid paraffin. In conclusion in treatment of pediatric functional constipation, regarding clinical efficacy and safety, PEG 3350 were at least as effective as liquid paraffin and but less adverse drug events. PMID:22615652

  2. Clinical Efficacy of Oral Ganciclovir for Prophylaxis and Treatment of Recurrent Herpes Simplex Keratitis

    Directory of Open Access Journals (Sweden)

    Xin Wang

    2015-01-01

    Full Text Available Background: Herpes simplex keratitis (HSK caused by herpes simplex virus 1 (HSV-1, which has high recurrent rate and incidence of severe vision loss, is the leading cause of infectious blindness in the world. The aim was to explore the clinical efficacy of oral ganciclovir (GCV in the prevention of recurrent HSK. Methods: A multicenter, prospective, randomized, single-blind, and controlled clinical trial was conducted from April 2010 to June 2013. One hundred seventy-three patients (173 eyes involved who were diagnosed as recurrent HSK definitely, including stromal keratitis and corneal endotheliitis, were divided into three groups randomly: negative control (placebo group was topically administered with 0.15% GCV ophthalmic gel, 4 times per day and 0.1% fluorometholone eye drops, 3 times per day until resolution of HSK; positive control acyclovir (ACV group was topically adopted the same ophthalmic gel and eye drops and additionally received oral ACV 400 mg 5 times a day for 10 weeks and followed by 400 mg 2 times per day for 6 months; test GCV group was topically adopted the same treatment as negative control group and additionally received oral GCV 1000 mg 3 times per day for 8 weeks. The symptoms and signs were evaluated before and after the therapy 1 st week, 2 nd week and then followed up every 2 weeks until recovery. Furthermore, we followed up recurrence of HSK for every 3 months after recovery and then assessed the cure time, recurrent rate and adverse reactions. Results: One hundred and seventy-three patients were followed up 7-48 months (mean 32.1 ± 12.3 months, but 34 patients were failed to follow-up. The cure time was 12.1 ± 4.3, 11.9 ± 4.0 weeks in negative control (placebo group and positive control ACV group respectively (P = 0.991, which was longer than that in test GCV group (8.6 ± 2.8 weeks and there was a significant difference between test GCV group and negative control (placebo group or positive control ACV group (P

  3. [Analyses of clinical features and efficacy of sudden deafness with vertigo and dizziness].

    Science.gov (United States)

    Liu, Bo; Han, Demin; Zhang, Yi; Li, Yongxin; Gong, Shusheng; Chen, Xiuwu; Meng, Xixi; Tang, Junxiang; Xiang, Jie; Jiang, Xuejun; Yang, Ning; Tian, Ying; Hui, Lian; Feng, Shuai

    2015-06-01

    To investigate the clinical characteristics and the effect of drug treatment for sudden hearing loss with vertigo or dizziness. In a prospective, randomized, single blinded randomized multicenter clinical study, patients with sudden deafness, ranging in age from 18 to 65 years old, with a duration less than 2 weeks, and with no any medical treatments were collected. In accordance with the hearing curve, those patients were divided into four types, i.e., low and intermediate frequency descent type; high frequency descent type; fall flat type; and total deafness type. Each type was treated by four different treatment options, according to the unified design of the random table, and randomly selected one of the options for treatment. The efficacy of the patients with sudden deafness with vertigo and dizziness was analyzed statistically after the follow-up for 4 weeks. SPSS 13.0 software was used to analyze the data. In August 2007 to October 2011, 33 hospitals in the country included 1 024 patients with sudden deafness in line with the inclusion criteria, of whom 296 (28.91%) were accompanied by vertigo/dizziness symptoms, 126 were males and 170 were females, with an average age of (41.2 ± 13.5) years old. types of the different audiometric curves of sudden deafness, the occurrence of complete deafness with vertigo/dizziness was the highest (44.93%), followed by flat down type (25.87%), high frequency descent type (21.28%) and low intermediate frequency descent type (18.54%). After the standard treatment, the vertigo and dizziness symptoms of the sudden deafness patients could disappear, and the hearing in each group was obviously improved. The hearing curative effect on patients accompanied by vertigo/dizziness of low frequency and intermediate frequency descent type was the best, and the total efficiency can reach up to 94.74%, with the cure rate of 68.42%; followed by flat type, in which the total effective rate was 80.76%, with the recovery rate of 22.12%; and

  4. Does self-efficacy predict return-to-work after sickness absence? A prospective study among 930 employees with sickness absence for three weeks or more

    DEFF Research Database (Denmark)

    Labriola, Merete; Lund, Thomas; Christensen, Karl B

    2007-01-01

    follows a cohort of 5357 working employees and 106 long-term sickness absent employees in Denmark. They were interviewed in 2000 regarding self-efficacy and various co-variates, and followed for 78 weeks in a national sickness absence register. Cox regression analysis was performed in order to assess...... or with Return-to-Work. CONCLUSION: The results may suggest that lower self-efficacy among employees with sickness absence is a result of the sickness absence itself rather than a precursor of it. This indicates a need to investigate the potential change in self-efficacy in relation to the employee's change......AIM: To compare levels of self-efficacy among the general working population and employees with sickness absence from work, and to examine if general self-efficacy measured before occurrence of sickness absence predicted subsequent onset of sickness absence and Return-to-Work. METHODS: The study...

  5. Acamprosate for treatment of alcohol dependence: mechanisms, efficacy, and clinical utility

    Directory of Open Access Journals (Sweden)

    Witkiewitz K

    2012-02-01

    Full Text Available Katie Witkiewitz, Kimber Saville, Kacie HamreusDepartment of Psychology, Washington State University Vancouver, Vancouver, WA, USAAbstract: Acamprosate, or N-acetyl homotaurine, is an N-methyl-D-aspartate receptor modulator approved by the Food and Drug Administration (FDA as a pharmacological treatment for alcohol dependence. The exact mechanism of action of acamprosate is still under investigation, but the drug appears to work by promoting a balance between the excitatory and inhibitory neurotransmitters, glutamate and gamma-aminobutyric acid, respectively, and it may help individuals with alcohol dependence by reducing withdrawal-associated distress. Acamprosate has low bioavailability, but also has an excellent tolerability and safety profile. In comparison with naltrexone and disulfiram, which are the other FDA-approved treatments for alcohol dependence, acamprosate is unique in that it is not metabolized by the liver and is also not impacted by alcohol use, so can be administered to patients with hepatitis or liver disease (a common comorbid condition among individuals with alcohol dependence and to patients who continue drinking alcohol. Acamprosate has demonstrated its efficacy in more than 25 placebo-controlled, double-blind trials for individuals with alcohol dependence, and has generally been found to be more efficacious than placebo in significantly reducing the risk of returning to any drinking and increasing the cumulative duration of abstinence. However, acamprosate appears to be no more efficacious than placebo in reducing heavy drinking days. Numerous trials have found that acamprosate is not significantly more efficacious than naltrexone or disulfiram, and the efficacy of acamprosate does not appear to be improved by combining acamprosate with other active medications (eg, naltrexone or with psychosocial treatment (eg, cognitive-behavioral therapy. In this review, we present the data on acamprosate, including its pharmacology

  6. Experimental models in predicting topical antifungal efficacy: practical aspects and challenges.

    Science.gov (United States)

    Lai, J; Maibach, H I

    2009-01-01

    What are efficient screening models for improved topical antifungals? The use of minimum inhibitory concentrations (MICs) as one such parameter is discussed; we focus on the use of animal membranes for in vitro testing while highlighting the pros and cons of each model, exploring alternatives and discussing the importance of data transferability to humans and the influence of penetration kinetics in topical antifungal efficacy. Ultimately, the gold standard of testing is in vivo in humans; however, initiating with human testing, especially for novel topical antifungal agents, may be impractical, which is why we seek the ideal experimental model that most closely mimics human skin. We conclude that the pig may be an appropriate model membrane for topical antifungal testing based on its similarities in anatomical structure, physiology and permeation to human skin. Most importantly, pig and human skins appear equally permeable to several antifungals in prior in vitro and in vivo work. We do not discuss all prior work but highlight important issues in designing the protocol and parameters of the ideal experimental model for topical antifungals. Copyright 2009 S. Karger AG, Basel.

  7. Efficacy of duplex ultrasound surveillance after infrainguinal vein bypass may be enhanced by identification of characteristics predictive of graft stenosis development.

    Science.gov (United States)

    Tinder, Chelsey N; Chavanpun, Joe P; Bandyk, Dennis F; Armstrong, Paul A; Back, Martin R; Johnson, Brad L; Shames, Murray L

    2008-09-01

    Controversy regarding the efficacy of duplex ultrasound surveillance after infrainguinal vein bypass led to an analysis of patient and bypass graft characteristics predictive for development of graft stenosis and a decision of secondary intervention. Retrospective analysis of a contemporary, consecutive series of 353 clinically successful infrainguinal vein bypasses performed in 329 patients for critical (n = 284; 80%) or noncritical (n = 69; 20%) limb ischemia enrolled in a surveillance program to identify and repair duplex-detected graft stenosis. Variables correlated with graft stenosis and bypass repair included: procedure indication, conduit type (saphenous vs nonsaphenous vein; reversed vs nonreversed orientation), prior bypass graft failure, postoperative ankle-brachial index (ABI) < 0.85, and interpretation of the first duplex surveillance study as "normal" or "abnormal" based on peak systolic velocity (PSV) and velocity ratio (Vr) criteria. Overall, 126 (36%) of the 353 infrainguinal bypasses had 174 secondary interventions (endovascular, 100; surgery, 74) based on duplex surveillance; resulting in 3-year Kaplan-Meier primary (46%), assisted-primary (80%), and secondary (81%) patency rates. Characteristics predictive of duplex-detected stenosis leading to intervention (PSV: 443 +/- 94 cm/s; Vr: 8.6 +/- 9) were: "abnormal" initial duplex testing indicating moderate (PSV: 180-300 cm/s, Vr: 2-3.5) stenosis (P < .0001), non-single segment saphenous vein conduit (P < .01), warfarin drug therapy (P < .01), and redo bypass grafting (P < .001). Procedure indication, postoperative ABI level, statin drug therapy, and vein conduit orientation were not predictive of graft revision. The natural history of 141 (40%) bypasses with an abnormal first duplex scan differed from "normal" grafts by more frequent (51% vs 24%, P < .001) and earlier (7 months vs 11 months) graft revision for severe stenosis and a lower 3-year assisted primary patency (68% vs 87%; P < .001). In 52

  8. Usefulness of Clinical Prediction Rules, D-dimer, and Arterial Blood Gas Analysis to Predict Pulmonary Embolism in Cancer Patients

    Directory of Open Access Journals (Sweden)

    Shazia Awan

    2017-03-01

    Full Text Available Objectives: Pulmonary embolism (PE is seven times more common in cancer patients than non-cancer patients. Since the existing clinical prediction rules (CPRs were validated predominantly in a non-cancer population, we decided to look at the utility of arterial blood gas (ABG analysis and D-dimer in predicting PE in cancer patients. Methods: Electronic medical records were reviewed between December 2005 and November 2010. A total of 177 computed tomography pulmonary angiograms (CTPAs were performed. We selected 104 individuals based on completeness of laboratory and clinical data. Patients were divided into two groups, CTPA positive (patients with PE and CTPA negative (PE excluded. Wells score, Geneva score, and modified Geneva score were calculated for each patient. Primary outcomes of interest were the sensitivities, specificities, positive, and negative predictive values for all three CPRs. Results: Of the total of 104 individuals who had CTPAs, 33 (31.7% were positive for PE and 71 (68.3% were negative. There was no difference in basic demographics between the two groups. Laboratory parameters were compared and partial pressure of oxygen was significantly lower in patients with PE (68.1 mmHg vs. 71 mmHg, p = 0.030. Clinical prediction rules showed good sensitivities (88−100% and negative predictive values (93−100%. An alveolar-arterial (A-a gradient > 20 had 100% sensitivity and negative predictive values. Conclusions: CPRs and a low A-a gradient were useful in excluding PE in cancer patients. There is a need for prospective trials to validate these results.

  9. Variables that Predict Serve Efficacy in Elite Men’s Volleyball with Different Quality of Opposition Sets

    Science.gov (United States)

    Valhondo, Álvaro; Fernández-Echeverría, Carmen; González-Silva, Jara; Claver, Fernando; Moreno, M. Perla

    2018-01-01

    Abstract The objective of this study was to determine the variables that predicted serve efficacy in elite men’s volleyball, in sets with different quality of opposition. 3292 serve actions were analysed, of which 2254 were carried out in high quality of opposition sets and 1038 actions were in low quality of opposition sets, corresponding to a total of 24 matches played during the Men’s European Volleyball Championships held in 2011. The independent variables considered in this study were the serve zone, serve type, serving player, serve direction, reception zone, receiving player and reception type; the dependent variable was serve efficacy and the situational variable was quality of opposition sets. The variables that acted as predictors in both high and low quality of opposition sets were the serving player, reception zone and reception type. The serve type variable only acted as a predictor in high quality of opposition sets, while the serve zone variable only acted as a predictor in low quality of opposition sets. These results may provide important guidance in men’s volleyball training processes. PMID:29599869

  10. A quantitative structure-activity relationship to predict efficacy of granular activated carbon adsorption to control emerging contaminants.

    Science.gov (United States)

    Kennicutt, A R; Morkowchuk, L; Krein, M; Breneman, C M; Kilduff, J E

    2016-08-01

    A quantitative structure-activity relationship was developed to predict the efficacy of carbon adsorption as a control technology for endocrine-disrupting compounds, pharmaceuticals, and components of personal care products, as a tool for water quality professionals to protect public health. Here, we expand previous work to investigate a broad spectrum of molecular descriptors including subdivided surface areas, adjacency and distance matrix descriptors, electrostatic partial charges, potential energy descriptors, conformation-dependent charge descriptors, and Transferable Atom Equivalent (TAE) descriptors that characterize the regional electronic properties of molecules. We compare the efficacy of linear (Partial Least Squares) and non-linear (Support Vector Machine) machine learning methods to describe a broad chemical space and produce a user-friendly model. We employ cross-validation, y-scrambling, and external validation for quality control. The recommended Support Vector Machine model trained on 95 compounds having 23 descriptors offered a good balance between good performance statistics, low error, and low probability of over-fitting while describing a wide range of chemical features. The cross-validated model using a log-uptake (qe) response calculated at an aqueous equilibrium concentration (Ce) of 1 μM described the training dataset with an r(2) of 0.932, had a cross-validated r(2) of 0.833, and an average residual of 0.14 log units.

  11. Clinical parameters predictive of malignancy of thyroid follicular neoplasms

    International Nuclear Information System (INIS)

    Davis, N.L.; Gordon, M.; Germann, E.; Robins, R.E.; McGregor, G.I.

    1991-01-01

    Needle aspiration biopsy is commonly employed in the evaluation of thyroid nodules. Unfortunately, the cytologic finding of a 'follicular neoplasm' does not distinguish between a thyroid adenoma and a follicular cancer. The purpose of this study was to identify clinical parameters that characterize patients with an increased risk of having a thyroid follicular cancer who preoperatively have a 'follicular neoplasm' identified by needle aspiration biopsy. A total of 395 patients initially treated at Vancouver General Hospital and the British Columbia Cancer Agency between the years of 1965 and 1985 were identified and their data were entered into a computer database. Patients with thyroid adenomas were compared to patients with follicular cancer using the chi-square test and Student's t-test. Statistically significant parameters that distinguished patients at risk of having a thyroid cancer (p less than 0.05) included age greater than 50 years, nodule size greater than 3 cm, and a history of neck irradiation. Sex, family history of goiter or neoplasm, alcohol and tobacco use, and use of exogenous estrogen were not significant parameters. Patients can be identified preoperatively to be at an increased risk of having a follicular cancer and accordingly appropriate surgical resection can be planned

  12. The Cannabis Dilemma: A Review of Its Associated Risks and Clinical Efficacy.

    Science.gov (United States)

    Zhang, Melvyn Weibin; Ho, Roger C M

    2015-01-01

    Cannabis, also known as marijuana, has 9-tetrahydrocannabinol as the main constituent. There has been strict legislation governing the utilization of cannabis locally and worldwide. However, there has been an increasing push to make cannabis legalized, in view of its potential medical and therapeutic effects, for various medical disorders ranging from development disorders to cancer treatment, and being an adjunctive medication for various neurological conditions. It is the aim of this review paper to explore the evidence base for its proposed therapeutic efficacy and to compare the evidence base supporting its proposed therapeutic efficacy with its known and well-researched medical and psychiatric side effects.

  13. The Cannabis Dilemma: A Review of Its Associated Risks and Clinical Efficacy

    Directory of Open Access Journals (Sweden)

    Melvyn Weibin Zhang

    2015-01-01

    Full Text Available Cannabis, also known as marijuana, has 9-tetrahydrocannabinol as the main constituent. There has been strict legislation governing the utilization of cannabis locally and worldwide. However, there has been an increasing push to make cannabis legalized, in view of its potential medical and therapeutic effects, for various medical disorders ranging from development disorders to cancer treatment, and being an adjunctive medication for various neurological conditions. It is the aim of this review paper to explore the evidence base for its proposed therapeutic efficacy and to compare the evidence base supporting its proposed therapeutic efficacy with its known and well-researched medical and psychiatric side effects.

  14. Multigene expression profile for predicting efficacy of cisplatin and vinorelbine in non-small cell lung cancer

    DEFF Research Database (Denmark)

    Buhl, I. K.; Christensen, I. J.; Santoni-Rugiu, E.

    2016-01-01

    Background: There is a need for biomarkers to predict efficacy of adjuvant chemotherapy in resected non-small cell lung cancer (NSCLC). Presented is a combined cisplatin and vinorelbine marker from a previously validated model system [1] tested in two cohorts. Methods: The profiles consist...... and vinorelbine (ACT) and 62 patients who had no adjuvant treatment (OBS) [2] and 2) 95 stage Ib-IIIb completely resected NSCLC patients who all received adjuvant cisplatin and vinorelbine [3]. Endpoint is cancer specific survival. Results: The combined cisplatin and vinorelbine profiles scored as a continuous...... of correlated in vitro cytotoxicity of cisplatin and vinorelbine and mRNA expressions. Then each profile is correlated to mRNA expression of 3500 tumors. The cohorts are 1) a publically available dataset with 133 completely resected stage Ib-II NSCLC patients, 71 of whom received adjuvant cisplatin...

  15. miR-125b-1 and miR-378a are predictive biomarkers for the efficacy of vaccine treatment against colorectal cancer.

    Science.gov (United States)

    Tanaka, Hironori; Hazama, Shoichi; Iida, Michihisa; Tsunedomi, Ryouichi; Takenouchi, Hiroko; Nakajima, Masao; Tokumitsu, Yukio; Kanekiyo, Shinsuke; Shindo, Yoshitaro; Tomochika, Shinobu; Tokuhisa, Yoshihiro; Sakamoto, Kazuhiko; Suzuki, Nobuaki; Takeda, Shigeru; Yamamoto, Shigeru; Yoshino, Shigefumi; Ueno, Tomio; Hamamoto, Yoshihiko; Fujita, Yusuke; Tanaka, Hiroaki; Tahara, Ko; Shimizu, Ryoichi; Okuno, Kiyotaka; Fujita, Koji; Kuroda, Masahiko; Nakamura, Yusuke; Nagano, Hiroaki

    2017-11-01

    Many clinical trials of peptide vaccines have been conducted. However, these vaccines have provided clinical benefits in only a small fraction of patients. The purpose of the present study was to explore microRNAs (miRNAs) as novel predictive biomarkers for the efficacy of vaccine treatment against colorectal cancer. First, we carried out microarray analysis of pretreatment cancer tissues in a phase I study, in which peptide vaccines alone were given. Candidate miRNAs were selected by comparison of the better prognosis group with the poorer prognosis group. Next, we conducted microarray analysis of cancer tissues in a phase II study, in which peptide vaccines combined with chemotherapy were given. Candidate miRNAs were further selected by a similar comparison of prognosis. Subsequently, we carried out reverse-transcription PCR analysis of phase II cases, separating cancer tissues into cancer cells and stromal tissue using laser capture microdissection. Treatment effect in relation to overall survival (OS) and miRNA expression was analyzed. Three miRNA predictors were negatively associated with OS: miR-125b-1 in cancer cells (P = 0.040), and miR-378a in both cancer cells (P = 0.009) and stromal cells (P colorectal cancer. © 2017 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.

  16. Locus of control, self-efficacy