A systematic review investigating the relationship between efficacy and stimulation parameters when using transcutaneous electrical nerve stimulation after knee arthroplasty.

PubMed

Beckwée, David; Bautmans, Ivan; Swinnen, Eva; Vermet, Yorick; Lefeber, Nina; Lievens, Pierre; Vaes, Peter

2014-01-01

To evaluate the clinical efficacy of transcutaneous electric nerve stimulation in the treatment of postoperative knee arthroplasty pain and to relate these results to the stimulation parameters used. PubMed, Pedro and Web of Knowledge were systematically screened for studies investigating effects of transcutaneous electric nerve stimulation on postoperative knee arthroplasty pain. Studies were screened for their methodological and therapeutical quality. We appraised the influence of the stimulation settings used and indicated whether or not a neurophysiological and/or mechanistic rationale was given for these stimulation settings. A total of 5 articles met the inclusion criteria. In total, 347 patients were investigated. The number of patients who received some form of transcutaneous electric nerve stimulation was 117, and 54 patients received sham transcutaneous electric nerve stimulation. Pain was the primary outcome in all studies. The stimulation settings used in the studies (n = 2) that reported significant effects differed from the others as they implemented a submaximal stimulation intensity. Stimulation parameters were heterogeneous, and only one study provided a rationale for them. This review reveals that an effect of transcutaneous electric nerve stimulation might have been missed due to low methodological and therapeutical quality. Justifying the choice of transcutaneous electric nerve stimulation parameters may improve therapeutical quality.

Primary School Teacher Perceived Self-Efficacy to Teach Fundamental Motor Skills

ERIC Educational Resources Information Center

Callea, Micarle B.; Spittle, Michael; O'Meara, James; Casey, Meghan

2008-01-01

Fundamental Movement Skills (FMS) are a part of the school curricula, yet many Australian primary-age children are not mastering FMS. One reason may be a lack of perceived self-efficacy of primary teachers to teach FMS. This study investigated the level of perceived self-efficacy of primary school teachers to teach FMS in Victoria, Australia. A…

Turkish Preservice Primary School Teachers' Science Teaching Efficacy Beliefs and Attitudes toward Science: The Effect of a Primary Teacher Education Program

ERIC Educational Resources Information Center

Bayraktar, Sule

2011-01-01

The main purpose of this study was to investigate the effectiveness of a primary teacher education program in improving science teaching efficacy beliefs (personal science teaching efficacy beliefs and outcome expectancy beliefs) of preservice primary school teachers. The study also investigated whether the program has an effect on student…

Comparison of Antipsychotics for Metabolic Problems (CAMP): A randomized trial examining the effectiveness of switching from olanzapine, quetiapine, or risperidone to aripiprazole to reduce metabolic risk

PubMed Central

Stroup, T. Scott; McEvoy, Joseph P.; Ring, Kimberly D.; Hamer, Robert H.; LaVange, Lisa M.; Swartz, Marvin S.; Rosenheck, Robert A.; Perkins, Diana O.; Nussbaum, Abraham M.; Lieberman, Jeffrey A.

2013-01-01

Objective We conducted a multi-site, randomized controlled trial examining the strategy of switching from olanzapine, quetiapine, or risperidone to aripiprazole to ameliorate metabolic risk factors for cardiovascular disease. Method Patients with schizophrenia or schizoaffective disorder with BMI ≥ 27 and non-HDL cholesterol (non-HDL-C) ≥ 130 mg/dl on a stable dosage of olanzapine, quetiapine, or risperidone were randomly assigned to stay on the current medication (n=106) or switch to aripiprazole (n=109) for 24 weeks. All participants were enrolled in a behaviorally oriented diet and exercise program. Raters were blinded to treatment assignment. The primary and key secondary outcomes were non-HDL-C change and efficacy failure, respectively. Results The pre-specified primary analysis included 89 switchers and 98 stayers who had at least one post-baseline non-HDL-C measurement. The least squares mean estimates of non-HDL-C decreased more for the switch than the stay groups (−20.2 vs. −10.8 mg/dl). Switching was associated with larger reductions in weight (2.9 kg) and a net reduction of serum triglycerides of 32.7 mg/dl. Twenty-two (20.6%) switchers and 18 (17.0%) stayers experienced protocol-defined efficacy failure. Forty-seven (43.9%) switchers and 26 (24.5%) stayers discontinued the assigned antipsychotic before 24 weeks. Conclusion Switching to aripiprazole led to improvement of non-HDL-C and other metabolic parameters. Rates of efficacy failure were similar between groups, but switching to aripiprazole was associated with a higher rate of treatment discontinuation. In the context of close clinical monitoring, switching from an antipsychotic with high metabolic risk to one with lower risk to improve metabolic parameters is an effective strategy. PMID:21768610

A Randomized, Crossover Trial of a Novel Sound-to-Sleep Mattress Technology in Children with Autism and Sleep Difficulties.

PubMed

Frazier, Thomas W; Krishna, Jyoti; Klingemier, Eric; Beukemann, Mary; Nawabit, Rawan; Ibrahim, Sally

2017-01-15

This preliminary study investigated the tolerability and efficacy of a novel mattress technology-the Sound-To-Sleep (STS) system-in the treatment of sleep problems in children with autism. After screening, 45 children, ages 2.5 to 12.9 years, were randomized to order of mattress technology use (On-Off vs. Off-On). Treatment conditions (On vs. Off) lasted two weeks with immediate crossover. Tolerability, including study discontinuation and parent-report of mattress tolerance and ease of use, was tracked throughout the study. Efficacy assessments were obtained at baseline, prior to crossover, and end of study and included measures of autism traits, other psychopathology symptoms, sensory abnormalities, communication difficulties, quality of life, sleep diary parameters, and single-blinded actigraphy-derived sleep parameters. Statistical analyses evaluated differences in tolerability and efficacy when the STS system was on versus off. STS system use was well tolerated (n = 2, 4.4% dropout) and resulted in parent-reported sleep quality improvements (STS off mean = 4.3, 95% CI = 4.05-4.54 vs. on mean = 4.9, 95%CI = 4.67-5.14). The technology was described by parents as very easy to use and child tolerance was rated as good. Parent-diary outcomes indicated improvements in falling asleep and reduced daytime challenging behavior. Actigraphy-derived sleep parameters indicated improved sleep duration and sleep efficiency. Improvements in child and family quality of life were identified on parent questionnaires. A future large sample phase 2 trial of the STS system is warranted and would benefit from extended study duration, an objective primary efficacy outcome, and careful attention to methodological issues that promote compliance with the intervention and study procedures. © 2017 American Academy of Sleep Medicine

Influencing Science Teaching Self-Efficacy Beliefs of Primary School Teachers: A Longitudinal Case Study

ERIC Educational Resources Information Center

McKinnon, Merryn; Lamberts, Rod

2014-01-01

The science teaching self-efficacy beliefs of primary school teachers influence teaching practice. The purpose of this research was to determine if informal education institutions, such as science centres, could provide professional development that influences the science teaching self-efficacy beliefs of pre-service and in-service primary school…

Primary School Teachers' Realization Levels of Self-Regulated Learning Practices and Sense of Efficacy

ERIC Educational Resources Information Center

Tanriseven, Isil

2013-01-01

The purpose of this study is to investigate primary school teachers' realization levels of self-regulated learning practices and sense of efficacy and the relationship between their realization levels of self-regulated learning practices and sense of efficacy. Survey research was conducted on 400 primary school teachers from 20 elementary schools…

Investigation of the electrical discharge parameters in electrodeless inductive lamps with a re-entrant coupler and magnetic core

NASA Astrophysics Data System (ADS)

Statnic, Eugen; Tanach, Valentin

2006-08-01

The inductively coupled fluorescent lamp with a cored induction coil placed in a re-entrant cavity is in fact a coaxial transformer operated in the radiofrequency range between 100 kHz and a few MHz. The magnetic coupling coefficient k between the primary coil and the plasma ring is relatively low because of the open magnetic circuit. The acting mutual inductance M enables us to quantify the interaction between the magnetic field produced by the primary coil current I1 and the opposing magnetic field produced by the powerful plasma current I2. A contra-electromotive force jωMI2 is induced in the induction coil L1, defining the primary voltage V1 = I1(R1 + jω L1) - jωMI2. The current I1 induces in the secondary conductive plasma the driving electromotive force jωMI1 supplying the secondary load consisting of the average plasma resistance R2 and the secondary inductance L2, according to the equation jωMI2 = I2(R2 + jωL2). It is the aim of this paper to find a model to determine k on the basis of the measured primary parameters V1, I1, P1, L1, R1 and finally all electrical inaccessible parameters, such as M, V2, I2, phiv2, L2, R2, in order to optimize the discharge and lamp efficacy. The complex characteristic of plasma inductance for this type of lamp is analysed and clarified. Some reflexive basic relations verifying the correctness of the inferred plasma parameters are also developed. The described experiments are related to a lamp working at about 2.6 MHz.

Nonpharmacologic treatment of chronic insomnia. An American Academy of Sleep Medicine review.

PubMed

Morin, C M; Hauri, P J; Espie, C A; Spielman, A J; Buysse, D J; Bootzin, R R

1999-12-15

This paper reviews the evidence regarding the efficacy of nonpharmacological treatments for primary chronic insomnia. It is based on a review of 48 clinical trials and two meta-analyses conducted by a task force appointed by the American Academy of Sleep Medicine to develop practice parameters on non-drug therapies for the clinical management of insomnia. The findings indicate that nonpharmacological therapies produce reliable and durable changes in several sleep parameters of chronic insomnia sufferers. The data indicate that between 70% and 80% of patients treated with nonpharmacological interventions benefit from treatment. For the typical patient with persistent primary insomnia, treatment is likely to reduce the main target symptoms of sleep onset latency and/or wake time after sleep onset below or near the 30-min criterion initially used to define insomnia severity. Sleep duration is also increased by a modest 30 minutes and sleep quality and patient's satisfaction with sleep patterns are significantly enhanced. Sleep improvements achieved with these behavioral interventions are sustained for at least 6 months after treatment completion. However, there is no clear evidence that improved sleep leads to meaningful changes in daytime well-being or performance. Three treatments meet the American Psychological Association (APA) criteria for empirically-supported psychological treatments for insomnia: Stimulus control, progressive muscle relaxation, and paradoxical intention; and three additional treatments meet APA criteria for probably efficacious treatments: Sleep restriction, biofeedback, and multifaceted cognitive-behavior therapy. Additional outcome research is needed to examine the effectiveness of treatment when it is implemented in clinical settings (primary care, family practice), by non-sleep specialists, and with insomnia patients presenting medical or psychiatric comorbidity.

Changes in Science Teaching Self-Efficacy among Primary Teacher Education Students

ERIC Educational Resources Information Center

Palmer, David; Dixon, Jeanette; Archer, Jennifer

2015-01-01

Many preservice primary teachers have low self-efficacy for science teaching. Although science methods courses have often been shown to enhance self-efficacy, science content courses have been relatively ineffective in this respect. This study investigated whether a tailored science content course would enhance self-efficacy. The participants were…

A systematic review investigating the relationship between efficacy and stimulation parameters when using transcutaneous electrical nerve stimulation after knee arthroplasty

PubMed Central

Beckwée, David; Bautmans, Ivan; Swinnen, Eva; Vermet, Yorick; Lefeber, Nina; Lievens, Pierre

2014-01-01

Objective: To evaluate the clinical efficacy of transcutaneous electric nerve stimulation in the treatment of postoperative knee arthroplasty pain and to relate these results to the stimulation parameters used. Data Sources: PubMed, Pedro and Web of Knowledge were systematically screened for studies investigating effects of transcutaneous electric nerve stimulation on postoperative knee arthroplasty pain. Review Methods: Studies were screened for their methodological and therapeutical quality. We appraised the influence of the stimulation settings used and indicated whether or not a neurophysiological and/or mechanistic rationale was given for these stimulation settings. Results: A total of 5 articles met the inclusion criteria. In total, 347 patients were investigated. The number of patients who received some form of transcutaneous electric nerve stimulation was 117, and 54 patients received sham transcutaneous electric nerve stimulation. Pain was the primary outcome in all studies. The stimulation settings used in the studies (n = 2) that reported significant effects differed from the others as they implemented a submaximal stimulation intensity. Stimulation parameters were heterogeneous, and only one study provided a rationale for them. Conclusion: This review reveals that an effect of transcutaneous electric nerve stimulation might have been missed due to low methodological and therapeutical quality. Justifying the choice of transcutaneous electric nerve stimulation parameters may improve therapeutical quality. PMID:26770730

Assessment of the anterior chamber parameters after laser iridotomy in primary angle close suspect using Pentacam and gonioscopy.

PubMed

Esmaeili, Alireza; Barazandeh, Behzad; Ahmadi, Sina; Haghi, Alireza; Ahmadi Hosseini, Seyed Mahdi; Abolbashari, Fereshteh

2013-01-01

To evaluate the changes in the anterior segment parameters of the subjects with primary angle closure suspect (PACS) before and after laser iridotomy (LI) using the Pentacam and gonioscopy. Forty-eight eyes of 48 PACS were included. Anterior chamber angle (ACA), central anterior chamber depth (ACD), anterior chamber volume (ACV) and central corneal thickness (CCT) were recorded from the Pentacam before and one month after LI. ACA was graded according to Shaffer classification using the Goldmann gonioscopy. ACA increased significantly from 25.59±4.41 to 26.46±4.33 degrees (P=0.009) and ACV changed from 85.97±16.07mm(3) to 99.25±15.83mm(3) (P=0.000). The changes in ACD, CCT and intraocular pressure were non-significant (P>0.05). Gonioscopy showed significant widening of the Shaffer angle in 4 quadrants (P<0.001). Pentacam can serve as the objective instrument in assessing the efficacy of LI.

Efficacy and safety of creatine supplementation in juvenile dermatomyositis: A randomized, double-blind, placebo-controlled crossover trial.

PubMed

Solis, Marina Yazigi; Hayashi, Ana Paula; Artioli, Guilherme Giannini; Roschel, Hamilton; Sapienza, Marcelo Tatit; Otaduy, Maria Concepción; De Sã Pinto, Ana Lucia; Silva, Clovis Artur; Sallum, Adriana Maluf Elias; Pereira, Rosa Maria R; Gualano, Bruno

2016-01-01

It has been suggested that creatine supplementation is safe and effective for treating idiopathic inflammatory myopathies, but no pediatric study has been conducted to date. The objective of this study was to examine the efficacy and safety of creatine supplementation in juvenile dermatomyositis (JDM) patients. In this study, JDM patients received placebo or creatine supplementation (0.1 g/kg/day) in a randomized, crossover, double-blind design. Subjects were assessed at baseline and after 12 weeks. The primary outcome was muscle function. Secondary outcomes included body composition, aerobic conditioning, health-related quality of life, and muscle phosphocreatine (PCr) content. Safety was assessed by laboratory parameters and kidney function measurements. Creatine supplementation did not affect muscle function, intramuscular PCr content, or any other secondary outcome. Kidney function was not affected, and no side effects were reported. Twelve weeks of creatine supplementation in JDM patients were well-tolerated and free of adverse effects, but treatment did not affect muscle function, intramuscular PCr, or any other parameter. © 2015 Wiley Periodicals, Inc.

A randomized, double-blind, placebo-controlled study to determine the safety and efficacy of cultured and expanded autologous fibroblast injections for the treatment of interdental papillary insufficiency associated with the papilla priming procedure.

PubMed

McGuire, Michael K; Scheyer, E Todd

2007-01-01

The aim of this study was to assess the efficacy and safety of using autologous fibroblast injections following a minimally invasive papilla priming procedure to augment open interproximal spaces. Twenty-one patients with open interproximal spaces were enrolled in this study, with 20 patients retained to study completion. Two primary sites were selected and randomized to receive autologous fibroblast injections or placebo injections beginning 1 week following the papilla priming procedure; two additional injections were performed 7 to 14 days following the initial injections. Up to seven additional sites could be treated per patient, and the analyses were conducted for the primary and secondary sites. The primary efficacy parameter was the percentage change in papillary height of the primary treatment areas from baseline to the 4-month visit, as measured by a periodontal probe from the base of the contact area to the tip of the interproximal papilla. Digital image analysis and diagnostic models were used to confirm clinical measurements. A visual analog scale (VAS) was used by the examiner and subject to assess the defect change from baseline to 2, 3, and 4 months. Tissue texture also was assessed by the examiner. The primary efficacy analysis failed to show a significant treatment effect at 4 months, but the treatment areas showed a statistically significant mean percentage increase from baseline in papillary height (P = 0.0067; signed-rank test) at 2 months. The difference between test and placebo sites in papillary height at 2 months approached statistical significance (P = 0.0730), suggesting that the test treatment was superior to the placebo treatment. The examiner and subject VASs were statistically significantly different from baseline for both treatment groups, and the VAS was superior for the test sites over the placebo. Based on safety data, the test treatment was deemed safe. This early-phase study using cell transplantation of autologous cultured and expanded fibroblasts following a papilla priming procedure suggests that the treatment is safe and may be efficacious for treating papillary insufficiency, especially in the early phases (2 months) of healing. The analysis of the investigator and subject VAS assessments indicates that the test treatment was superior to the placebo treatment. The finite measurement required to detect a change creates a problem that needs to be addressed in future studies.

Efficacy and safety of imidacloprid/moxidectin spot-on solution and fenbendazole in the treatment of dogs naturally infected with Angiostrongylus vasorum (Baillet, 1866).

PubMed

Willesen, J L; Kristensen, A T; Jensen, A L; Heine, J; Koch, J

2007-07-20

A randomized, blinded, controlled multicentre field trial study was conducted to evaluate the efficacy and safety of imidacloprid 10%/moxidectin 2.5% spot-on solution and fenbendazole in treating dogs naturally infected with Angiostrongylus vasorum. Dogs were randomly treated either with a single dose of 0.1 ml/kg bodyweight of imidacloprid 10%/moxidectin 2.5% spot-on solution or with 25 mg/kg bodyweight fenbendazole per os for 20 days. The study period was 42 days with dogs being examined on days 0, 7 and 42. The primary efficacy parameter was the presence of L1 larvae in faecal samples evaluated by a Baermann test from three consecutive days. Thoracic radiographs performed on each visit were being taken as a paraclinical parameter to support the results of the Baermann test. Twenty-seven dogs in the imidacloprid/moxidectin group and 23 dogs in the fenbendazole group completed the study according to protocol. The efficacies of the two treatment protocols were 85.2% (imidacloprid/moxidectin) and 91.3% (fenbendazole) with no significant difference between treatment groups. On radiographic evaluation pulmonary parenchyma showed similar improvement in each group. No serious adverse effects to treatment were recorded: most of the minor adverse effects were gastrointestinal such as diarrhea (nine dogs), vomitus (eight dogs) and salivation (three dogs). In general, these adverse effects were of short duration (1-2 days) within the first few days after treatment start and required little or no treatment. This prospective study demonstrates that both treatment protocols used are efficacious under field conditions, that treatment of mildly to moderately infected dogs with either of these protocols is safe and yields an excellent prognosis for recovering from the infection.

Teacher Training and Pre-Service Primary Teachers' Self-Efficacy for Science Teaching

ERIC Educational Resources Information Center

Velthuis, Chantal; Fisser, Petra; Pieters, Jules

2014-01-01

This study focuses on the improvement of pre-service teachers' self-efficacy for teaching science by including science courses within the teacher training program. Knowing how efficacy beliefs change over time and what factors influence the development by pre-service primary teachers of positive science teaching efficacy beliefs may be useful for…

Sources of Self-Efficacy in a Science Methods Course for Primary Teacher Education Students

ERIC Educational Resources Information Center

Palmer, D. H.

2006-01-01

Self-efficacy has been shown to be an issue of concern for primary teacher education students--many of them have low self-efficacy and this can negatively affect their future teaching of science. Previous research has identified four factors that may contribute towards self-efficacy: enactive mastery experiences, vicarious experiences, verbal…

Urine oxalate biological variation in patients with primary hyperoxaluria.

PubMed

Clifford-Mobley, Oliver; Sjögren, Anna; Lindner, Elisabeth; Rumsby, Gill

2016-08-01

Hyperoxaluria is a well-recognised risk factor for urolithiasis and patients with primary hyperoxaluria (PH) gradually build up calcium oxalate deposits leading to chronic kidney disease. Efforts to improve treatment for PH have focused on reducing urine oxalate excretion and thus decreasing lithogenesis. To determine the efficacy of treatments designed to alter a biochemical parameter it is necessary to know the biological and analytical variation of that parameter. In this study, we estimated the intra-individual biological variation of urine oxalate excretion in patients with PH, and from this determined what would constitute a significant change in the form of a reference change value (RCV). Each patient collected four 24-h urines on consecutive weeks. The intra-individual biological variation of oxalate excretion calculated from these samples ranged from 0 to 36 % with a mean of 14 %. The corresponding RCVs were 4-84 % with a mean of 32 %. This result implies that, on average, a reduction of almost one-third in urine oxalate excretion is required to prove an effect from treatment. The wide range of biological variation between individuals may reflect other, as yet unknown, determinants of oxaluria in PH, as well as inaccuracies in urine collection. The data suggest that it is more appropriate to use individual RCVs established prior to treatment to determine its efficacy: a relatively small fall in urine oxalate excretion may be outside the biological variation of some patients but not of others.

Clinician Agreement, Self-Efficacy, and Adherence with the Guidelines for the Diagnosis and Management of Asthma.

PubMed

Cloutier, Michelle M; Salo, Paivi M; Akinbami, Lara J; Cohn, Richard D; Wilkerson, Jesse C; Diette, Gregory B; Williams, Sonja; Elward, Kurtis S; Mazurek, Jacek M; Spinner, Jovonni R; Mitchell, Tracey A; Zeldin, Darryl C

The 2007 Guidelines for the Diagnosis and Management of Asthma provide evidence-based recommendations to improve asthma care. Limited national-level data are available about clinician agreement and adherence to these guidelines. To assess clinician-reported adherence with specific guideline recommendations, as well as agreement with and self-efficacy to implement guidelines. We analyzed 2012 National Asthma Survey of Physicians data for 1412 primary care clinicians and 233 asthma specialists about 4 cornerstone guideline domains: asthma control, patient education, environmental control, and pharmacologic treatment. Agreement and self-efficacy were measured using Likert scales; 2 overall indices of agreement and self-efficacy were compiled. Adherence was compared between primary care clinicians and asthma specialists. Logistic regression models assessed the association of agreement and self-efficacy indices with adherence. Asthma specialists expressed stronger agreement, higher self-efficacy, and greater adherence with guideline recommendations than did primary care clinicians. Adherence was low among both groups for specific core recommendations, including written asthma action plan (30.6% and 16.4%, respectively; P < .001); home peak flow monitoring, (12.8% and 11.2%; P = .34); spirometry testing (44.7% and 10.8%; P < .001); and repeated assessment of inhaler technique (39.7% and 16.8%; P < .001). Among primary care clinicians, greater self-efficacy was associated with greater adherence. For specialists, self-efficacy was associated only with increased odds of spirometry testing. Guideline agreement was generally not associated with adherence. Agreement with and adherence to asthma guidelines was higher for specialists than for primary care clinicians, but was low in both groups for several key recommendations. Self-efficacy was a good predictor of guideline adherence among primary care clinicians but not among specialists. Published by Elsevier Inc.

Comparison of Therapeutic Efficacies of Norethisterone, Tranexamic Acid and Levonorgestrel-Releasing Intrauterine System for the Treatment of Heavy Menstrual Bleeding: A Randomized Controlled Study.

PubMed

Kiseli, Mine; Kayikcioglu, Fulya; Evliyaoglu, Ozlem; Haberal, Ali

2016-01-01

Our aim was to compare the therapeutic efficacies of norethisterone acid (NETA), tranexamic acid and levonorgestrel-releasing intrauterine system (LNG-IUS) in treating idiopathic heavy menstrual bleeding (HMB). Women with heavy uterine bleeding were randomized to receive NETA, tranexamic acid or LNG-IUS for 6 months. The primary outcome was a decrease in menstrual bleeding as assessed by pictorial blood loss assessment charts and hematological parameters analyzed at the 1st, 3rd and 6th months. Health-related quality of life (QOL) variables were also recorded and analyzed. Twenty-eight patients were enrolled in each treatment group, but the results of only 62 were evaluated. NETA, tranexamic acid, and LNG-IUS reduced menstrual blood loss (MBL) by 53.1, 60.8, and 85.8%, respectively, at the 6th month. LNG-IUS was more effective than NETA and tranexamic acid in decreasing MBL. LNG-IUS was also more efficient than tranexamic acid in correcting anemia related to menorrhagia. Satisfaction rates were comparable among the NETA (70%), tranexamic acid (63%) and LNG-IUS (77%) groups. QOL in physical aspects increased significantly in the tranexamic acid and LNG-IUS groups. The positive effect of LNG-IUS on QOL parameters, as well as its high efficacy, makes it a first-line option for HMB. © 2016 S. Karger AG, Basel.

Efficacy and safety of oral alitretinoin in severe oral lichen planus--results of a prospective pilot study.

PubMed

Kunz, M; Urosevic-Maiwald, M; Goldinger, S M; Frauchiger, A L; Dreier, J; Belloni, B; Mangana, J; Jenni, D; Dippel, M; Cozzio, A; Guenova, E; Kamarachev, J; French, L E; Dummer, R

2016-02-01

Patients with severe oral lichen planus refractory to standard topical treatment currently have limited options of therapy suitable for long-term use. Oral alitretinoin (9-cis retinoic acid) was never systematically investigated in clinical trials, although case reports suggest its possible efficacy. To assess the efficacy and safety of oral alitretinoin taken at 30 mg once daily for up to 24 weeks in the treatment of severe oral lichen planus refractory to standard topical therapy. We conducted a prospective open-label single arm pilot study to test the efficacy and safety of 30 mg oral alitretinoin once daily for up to 24 weeks in severe oral lichen planus. Ten patients were included in the study. Primary end point was reduction in signs and symptoms measured by the Escudier severity score. Secondary parameters included pain and quality of life scores. Safety parameters were assessed during a follow-up period of 5 weeks. A substantial response at the end of treatment, i.e. >50% reduction in disease severity measured by the Escudier severity score, was apparent in 40% of patients. Therapy was well tolerated. Adverse events were mild and included headache, mucocutaneous dryness, musculoskeletal pain, increased thyroid-stimulating hormone and dyslipidaemia. Alitretinoin given at 30 mg daily reduced disease severity of severe oral lichen planus in a substantial proportion of patients refractory to standard treatment, was well tolerated and may thus represent one therapeutic option for this special group of patients. © 2015 European Academy of Dermatology and Venereology.

The impact of a disease management program (COACH) on the attainment of better cardiovascular risk control in dyslipidaemic patients at primary care centres (The DISSEMINATE Study): a randomised controlled trial

PubMed Central

2012-01-01

Background To evaluate the efficacy of Counselling and Advisory Care for Health (COACH) programme in managing dyslipidaemia among primary care practices in Malaysia. This open-label, parallel, randomised controlled trial compared the COACH programme delivered by primary care physicians alone (PCP arm) and primary care physicians assisted by nurse educators (PCP-NE arm). Methods This was a multi-centre, open label, randomised trial of a disease management programme (COACH) among dyslipidaemic patients in 21 Malaysia primary care practices. The participating centres enrolled 297 treatment naïve subjects who had the primary diagnosis of dyslipidaemia; 149 were randomised to the COACH programme delivered by primary care physicians assisted by nurse educators (PCP-NE) and 148 to care provided by primary care physicians (PCP) alone. The primary efficacy endpoint was the mean percentage change from baseline LDL-C at week 24 between the 2 study arms. Secondary endpoints included mean percentage change from baseline of lipid profile (TC, LDL-C, HDL-C, TG, TC: HDL ratio), Framingham Cardiovascular Health Risk Score and absolute risk change from baseline in blood pressure parameters at week 24. The study also assessed the sustainability of programme efficacy at week 36. Results Both study arms demonstrated improvement in LDL-C from baseline. The least squares (LS) mean change from baseline LDL-C were −30.09% and −27.54% for PCP-NE and PCP respectively. The difference in mean change between groups was 2.55% (p=0.288), with a greater change seen in the PCP-NE arm. Similar observations were made between the study groups in relation to total cholesterol change at week 24. Significant difference in percentage change from baseline of HDL-C were observed between the PCP-NE and PCP groups, 3.01%, 95% CI 0.12-5.90, p=0.041, at week 24. There was no significant difference in lipid outcomes between 2 study groups at week 36 (12 weeks after the programme had ended). Conclusion Patients who received coaching and advice from primary care physicians (with or without the assistance by nurse educators) showed improvement in LDL-cholesterol. Disease management services delivered by PCP-NE demonstrated a trend towards add-on improvements in cholesterol control compared to care delivered by physicians alone; however, the improvements were not maintained when the services were withdrawn. Trial registration National Medical Research Registration (NMRR) Number: NMRR-08-287-1442 Trial Registration Number (ClinicalTrials.gov Identifier): NCT00708370 PMID:23046818

The impact of a disease management program (COACH) on the attainment of better cardiovascular risk control in dyslipidaemic patients at primary care centres (The DISSEMINATE Study): a randomised controlled trial.

PubMed

Selvaraj, Francis Jude; Mohamed, Mafauzy; Omar, Khairani; Nanthan, Sudha; Kusiar, Zainab; Subramaniam, Selvaraj Y; Ali, Norsiah; Karanakaran, Kamalakaran; Ahmad, Fauziah; Low, Wilson H H

2012-10-10

To evaluate the efficacy of Counselling and Advisory Care for Health (COACH) programme in managing dyslipidaemia among primary care practices in Malaysia. This open-label, parallel, randomised controlled trial compared the COACH programme delivered by primary care physicians alone (PCP arm) and primary care physicians assisted by nurse educators (PCP-NE arm). This was a multi-centre, open label, randomised trial of a disease management programme (COACH) among dyslipidaemic patients in 21 Malaysia primary care practices. The participating centres enrolled 297 treatment naïve subjects who had the primary diagnosis of dyslipidaemia; 149 were randomised to the COACH programme delivered by primary care physicians assisted by nurse educators (PCP-NE) and 148 to care provided by primary care physicians (PCP) alone. The primary efficacy endpoint was the mean percentage change from baseline LDL-C at week 24 between the 2 study arms. Secondary endpoints included mean percentage change from baseline of lipid profile (TC, LDL-C, HDL-C, TG, TC: HDL ratio), Framingham Cardiovascular Health Risk Score and absolute risk change from baseline in blood pressure parameters at week 24. The study also assessed the sustainability of programme efficacy at week 36. Both study arms demonstrated improvement in LDL-C from baseline. The least squares (LS) mean change from baseline LDL-C were -30.09% and -27.54% for PCP-NE and PCP respectively. The difference in mean change between groups was 2.55% (p=0.288), with a greater change seen in the PCP-NE arm. Similar observations were made between the study groups in relation to total cholesterol change at week 24. Significant difference in percentage change from baseline of HDL-C were observed between the PCP-NE and PCP groups, 3.01%, 95% CI 0.12-5.90, p=0.041, at week 24. There was no significant difference in lipid outcomes between 2 study groups at week 36 (12 weeks after the programme had ended). Patients who received coaching and advice from primary care physicians (with or without the assistance by nurse educators) showed improvement in LDL-cholesterol. Disease management services delivered by PCP-NE demonstrated a trend towards add-on improvements in cholesterol control compared to care delivered by physicians alone; however, the improvements were not maintained when the services were withdrawn. National Medical Research Registration (NMRR) Number: NMRR-08-287-1442Trial Registration Number (ClinicalTrials.gov Identifier): NCT00708370.

Efficacy of standardized extract of Hibiscus sabdariffa L. (Malvaceae) in improving iron status of adults in malaria endemic area: A randomized controlled trial.

PubMed

Peter, Emanuel L; Rumisha, Susan F; Mashoto, Kijakazi O; Minzi, Omary Ms; Mfinanga, Sayoki

2017-09-14

Indigenous community of Mkuranga district have been using aqueous extract of H. sabdariffa L. for treating anemia. However, there have been neither safety nor efficacy studies to validate this medicinal product in anemia. The purpose of this study was to establish efficacy and safety of standardized aqueous extract of H. sabdariffa L. in anemic adults. This was a randomized controlled clinical trial in which 130 adults' men and women aged 18-50 years were involved after meeting the inclusion criteria. Initially, standardized aqueous extract of H. sabdariffa L. was prepared using optimized extraction parameters. Stratified randomization was used to randomize participants into four fixed dose groups. The first group received oral dose of 1000ml while the 2nd group was randomized to receive 1500ml orally. The last two groups were given a dose of 2000ml of extract and 200mg ferrous sulphate tablet respectively. Primary endpoint was the actual change of iron status indicators at the end of 30 days follow up period as compared to those recorded at baseline. Adverse effects were assessed at every 10th day scheduled visit. In all arms, HB and hematopoietic parameters were measured using HemoCue hemoglobinometer® (HemoCue, Ängelholm, Sweden) and hematology analyzer® respectively at the trial site. Follow up was done for 30 days. A total of 82 participants were included for analysis. A standardized aqueous extract of H. sabdariffa L. did not improve iron status in anemic adults in malaria endemic region (P>0.005). However, there was evidence to support the safety of the extract for human consumptions as herbal supplement. Iron and organic acids contents of H. sabdariffa L. extract showed the potential of improving hematopoietic parameters. Studies with bigger sample size are therefore needed to establish the efficacy of the extract when concurrently used with malaria chemoprophylaxis in malaria endemic areas. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

The safety, tolerability, and efficacy of once-daily memantine (28 mg): a multinational, randomized, double-blind, placebo-controlled trial in patients with moderate-to-severe Alzheimer's disease taking cholinesterase inhibitors.

PubMed

Grossberg, George T; Manes, Facundo; Allegri, Ricardo F; Gutiérrez-Robledo, Luis Miguel; Gloger, Sergio; Xie, Lei; Jia, X Daniel; Pejović, Vojislav; Miller, Michael L; Perhach, James L; Graham, Stephen M

2013-06-01

Immediate-release memantine (10 mg, twice daily) is approved in the USA for moderate-to-severe Alzheimer's disease (AD). This study evaluated the efficacy, safety, and tolerability of a higher-dose, once-daily, extended-release formulation in patients with moderate-to-severe AD concurrently taking cholinesterase inhibitors. In this 24-week, double-blind, multinational study (NCT00322153), outpatients with AD (Mini-Mental State Examination scores of 3-14) were randomized to receive once-daily, 28-mg, extended-release memantine or placebo. Co-primary efficacy parameters were the baseline-to-endpoint score change on the Severe Impairment Battery (SIB) and the endpoint score on the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-Plus). The secondary efficacy parameter was the baseline-to-endpoint score change on the 19-item Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL19); additional parameters included the baseline-to-endpoint score changes on the Neuropsychiatric Inventory (NPI) and verbal fluency test. Data were analyzed using a two-way analysis of covariance model, except for CIBIC-Plus (Cochran-Mantel-Haenszel test). Safety and tolerability were assessed through adverse events and physical and laboratory examinations. A total of 677 patients were randomized to receive extended-release memantine (n = 342) or placebo (n = 335); completion rates were 79.8 and 81.2 %, respectively. At endpoint (week 24, last observation carried forward), memantine-treated patients significantly outperformed placebo-treated patients on the SIB (least squares mean difference [95 % CI] 2.6 [1.0, 4.2]; p = 0.001), CIBIC-Plus (p = 0.008), NPI (p = 0.005), and verbal fluency test (p = 0.004); the effect did not achieve significance on ADCS-ADL19 (p = 0.177). Adverse events with a frequency of ≥5.0 % that were more prevalent in the memantine group were headache (5.6 vs. 5.1 %) and diarrhea (5.0 vs. 3.9 %). Extended-release memantine was efficacious, safe, and well tolerated in this population.

Citalopram and escitalopram in the treatment of major depressive disorder: a pooled analysis of 3 clinical trials.

PubMed

Li, Huafang; Li, Ting; Li, Guanjun; Luo, Jianfeng

2014-11-01

Pooled analysis is a powerful technique that is increasingly used to detect differences in efficacy between pharmacologic agents. Some studies have compared the efficacy and tolerability of citalopram and escitalopram, with contradictory results. The aim of this study was to compare the efficacy and tolerability of citalopram and escitalopram in the treatment of major depressive disorder (MDD) using pooled analyses. Data from 3 randomized, double-blind studies that compared citalopram (20 to 40 mg/d) and escitalopram (10 to 20 mg/d) were pooled and analyzed. The primary efficacy parameter was change from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D-17) total score. Efficacy assessments were made at weeks 0 (baseline), 1, 2, 4, and 6. Based on the mean change from baseline in the HAM-D-17 at weeks 1, 2, 4, and 6, the efficacy of citalopram, 20 to 40 mg/d, was equivalent to escitalopram, 10 to 20 mg/d (P > .05). Similar results were seen for severely depressed patients, with a mean treatment difference of 13.9 (SE = 7.6) vs 15.9 (SE = 7.5). Response and remission rates at week 6 were similar (response, 72.4% for citalopram, compared with 73.5% for escitalopram; remission, 52.6% vs 54.5%, respectively). The pooled analysis showed that over a 6-week treatment period, citalopram, 20 to 40 mg/d, is equivalent to escitalopram, 10 to 20 mg/d, in both efficacy and tolerability.

The efficacy and safety of amoxicillin-clavulanic acid 1000/125mg twice daily extended release (XR) tablet for the treatment of bacterial community-acquired pneumonia in adults.

PubMed

Prabhudesai, P P; Jain, Sanjay; Keshvani, Aziz; Kulkarni, K P

2011-02-01

This study was designed to demonstrate the efficacy and safety of pharmacokinetically enhanced amoxicillin/clavulanic acid 2000 mg/125 mg extended release formulation (ER), than conventional formulations against community-acquired respiratory tract pathogens, particularly Streptococcus pneumoniae, with reduced susceptibility to amoxicillin. This is an open labelled, multicentric, prospective, interventional study carried out across India from June 2008 to March 2009. The study included adult patients (>18 years), weighing between 40 to 60 kg with radiologically confirmed community-acquired pneumonia (CAP). Primary efficacy parameters were clinical response (fever, cough severity, sputum characteristics and improvement in dyspnoea grades) and laboratory parameters. Secondary efficacy parameters were radiological and bacteriological findings at the end of therapy. A total, 727 clinically and radiologically confirmed community-acquired pneumonia patients were enrolled in this study. Eighteen patients were lost to follow-up during study and 709 completed the study as per the study protocol. There was a significant improvement in clinical as well as laboratory parameters at the end of therapy. There was a significant improvement in fever, cough severity, sputum characteristic and dyspnoea grades from 101.88 +/- 1.55, 2.18 +/- 0.76, 1.75 +/- 0.77 and 1.91 +/- 1.23 to 98.14 +/- 0.87 (p < 0.0001), 0.24 +/- 0.45 (p < 0.0001), 0.14 +/- 0.39 (p < 0.0001) and 0.20 +/- 0.47 (p < 0.0001) respectively. Laboratory parameters such as total WBC count and neutrophil percentage decreased significantly from 15317 +/- 662 and 80 +/- 9 to 9067 +/- 558 (p < 0.0001) and 67 +/- 9 (p < 0.0001) respectively at the end of treatment. Bacteriological success and radiological success for amoxicillin-clavulanate 1,000/62.5 mg at the end of treatment was 94.33% (150 of 159) and 98.7% (700 of 709) respectively. Mild to moderate diarrhoea was reported in 61/709 patients (8.6%). Amoxicillin-clavulanate 1,000/62.5 mg given twice daily for ten days was shown to be clinically effective and safe in the treatment of community-acquired pneumonia in adult patients. Therapy was well tolerated. [J Indian Med Assoc 2011; 109: 124-7

A 2-night, 3-period, crossover study of ramelteon's efficacy and safety in older adults with chronic insomnia.

PubMed

Roth, Thomas; Seiden, David; Wang-Weigand, Sherry; Zhang, Jeffrey

2007-05-01

To assess the efficacy and safety of ramelteon, a selective melatonin MT1/MT2-receptor agonist, for insomnia treatment in older adults. In a randomized, 9-week, 3-period crossover trial conducted at 17 sleep centers, older adults (N = 100) with chronic primary insomnia (37 men, 63 women; mean age [range], 70.7 [65-83] years) were administered placebo, ramelteon 4 mg, and ramelteon 8 mg in three treatment phases for two consecutive nights. Each phase was separated by 5- to 12-day washout periods. Sleep was monitored via polysomnography. Subjective sleep parameters, using a Postsleep Questionnaire, were recorded, and residual pharmacologic effects were assessed. Statistically significant reductions in latency to persistent sleep were observed with both ramelteon 4 mg and 8 mg compared to placebo (28.7 min vs. 38.4 min, p < 0.001; 30.8 min vs. 38.4 min, p = 0.005, respectively). Total sleep time (p = 0.036 and p = 0.007, respectively) and sleep efficiency (p = 0.037 and p = 0.007, respectively) were also significantly improved with ramelteon 4 mg and 8 mg compared to placebo. Statistically significant reductions in subjective sleep latency on a Postsleep Questionnaire were reported with ramelteon 4 mg versus placebo (p = 0.037), but not ramelteon 8 mg (p = 0.120); no significant differences on other subjective sleep assessments were reported. A lack of power limits interpretation of self-reported sleep parameters. Incidences of adverse events considered treatment related were placebo (7%), ramelteon 4 mg (11%), and ramelteon 8 mg (5%). No residual pharmacologic effects were observed via Digit Symbol Substitution Test, memory recall tests (immediate and delayed), visual analog scales (feelings and mood), and Postsleep Questionnaire (level of alertness and ability to concentrate). In older adults with chronic primary insomnia, ramelteon produced significant reductions in latency to persistent sleep and increases in total sleep time and sleep efficacy, and showed no evidence of adverse next-day psychomotor or cognitive effects.

MiDAS ENCORE: Randomized Controlled Clinical Trial Report of 6-Month Results.

PubMed

Staats, Peter S; Benyamin, Ramsin M

2016-02-01

Patients suffering from neurogenic claudication due to lumbar spinal stenosis (LSS) often experience moderate to severe pain and significant functional disability. Neurogenic claudication results from progressive degenerative changes in the spine, and most often affects the elderly. Both the MILD® procedure and epidural steroid injections (ESIs) offer interventional pain treatment options for LSS patients experiencing neurogenic claudication refractory to more conservative therapies. MILD provides an alternative to ESIs via minimally invasive lumbar decompression. Prospective, multi-center, randomized controlled clinical trial. Twenty-six US interventional pain management centers. To compare patient outcomes following treatment with either MILD (treatment group) or ESIs (active control group) in LSS patients with neurogenic claudication and verified ligamentum flavum hypertrophy. This prospective, multi-center, randomized controlled clinical trial includes 2 study arms with a 1-to-1 randomization ratio. A total of 302 patients were enrolled, with 149 randomized to MILD and 153 to the active control. Six-month follow-up has been completed and is presented in this report. In addition, one year follow-up will be conducted for patients in both study arms, and supplementary 2 year outcome data will be collected for patients in the MILD group only. Outcomes are assessed using the Oswestry Disability Index (ODI), numeric pain rating scale (NPRS) and Zurich Claudication Questionnaire (ZCQ). Primary efficacy is the proportion of ODI responders, tested for statistical superiority of the MILD group versus the active control group. ODI responders are defined as patients achieving the validated Minimal Important Change (MIC) of =10 point improvement in ODI from baseline to follow-up. Similarly, secondary efficacy includes proportion of NPRS and ZCQ responders using validated MIC thresholds. Primary safety is the incidence of device or procedure-related adverse events in each group. At 6 months, all primary and secondary efficacy results provided statistically significant evidence that MILD is superior to the active control. For primary efficacy, the proportion of ODI responders in the MILD group (62.2%) was statistically significantly higher than for the epidural steroid group (35.7%) (P < 0.001). Further, all secondary efficacy parameters demonstrated statistical superiority of MILD versus the active control. The primary safety endpoint was achieved, demonstrating that there is no difference in safety between MILD and ESIs (P = 1.00). Limitations include lack of patient blinding due to considerable differences in treatment protocols, and a potentially higher non-responder rate for both groups versus standard-of-care due to study restrictions on adjunctive pain therapies. Six month follow-up data from this trial demonstrate that the MILD procedure is statistically superior to epidural steroids, a known active treatment for LSS patients with neurogenic claudication and verified central stenosis due to ligamentum flavum hypertrophy. The results of all primary and secondary efficacy outcome measures achieved statistically superior outcomes in the MILD group versus ESIs. Further, there were no statistically significant differences in the safety profile between study groups. This prospective, multi-center, randomized controlled clinical trial provides strong evidence of the effectiveness of MILD versus epidural steroids in this patient population. NCT02093520.

Primary Education Teachers' Self-Efficacy Beliefs for Teaching Geography Lessons

ERIC Educational Resources Information Center

Bent, Gert Jan; Bakx, Anouke; den Brok, Perry

2017-01-01

This study was carried out to investigate the primary education teachers' self-efficacy regarding geography education, their beliefs regarding the classroom learning environment, and how these beliefs were related to each other and to teachers' background characteristics. Questionnaire data were collected from 489 Dutch primary school teachers.…

A nurse-guided, basal-prandial insulin treatment protocol for achieving glycaemic control of hospitalized, non-critically ill diabetes patients, is non-inferior to physician-guided therapy: A pivotal, nurse-empowerment study.

PubMed

Segal, Gad; Karniel, Eli; Mahagna, Ahmed; Kaa'dan, Fadi; Levi, Zehava; Balik, Chaya

2015-12-01

Basal-prandial insulin is established for glycaemic control for hospitalized, type 2 diabetes patients. Empowering nurses to guide such protocols could be advantageous.The study aims to comparatively assess the efficacy and safety of glycaemic control by a nurse-guided protocol with physician-guided therapy. It also aims to assess the impact of empowerment on the nurses' sense of competence. This is a prospective, controlled, randomized, single-blinded study. Validated protocol utilizing basal-prandial insulin was used. Glycaemic control was the primary efficacy outcome, whereas hypoglycaemia and laboratory parameters were followed for safety. Assessment of nurses' psychological empowerment was done. One hundred fifty-eight treatment days of 53 patients were included. Patients were randomized to either study group (n = 27) or control group (n = 26). Glycaemia deviation from liberal range (60-300 mg/dL) was 7.4% of days for nurse-guided, basal-prandial insulin treatment protocol (NGP) and 7.84% for physician-guided therapy (PGT), P = 0.901. Rate of glycaemia deviation from the strict range (100-180 mg/dL) was 49.76% for NGP and 47.38% for PGT, P = 0.703. Mean range of daily deviation was similar (77.05 mg/dL for NGP and 76.04 mg/dL for PGT, P = 0.93). There were no significant differences in safety parameters. An empowerment questionnaire showed tendency for increased nurses' sense of competence. Nurse-guided protocol is non-inferior to physician-guided treatment in efficacy and safety parameters. Nurses' sense of competence was positively influenced. © 2014 Wiley Publishing Asia Pty Ltd.

Thalidomide combined with transcatheter artierial chemoembolzation for primary hepatocellular carcinoma: a systematic review and meta-analysis

PubMed Central

Cao, De-Dong; Xu, Hui-Lin; Liu, Liang; Zheng, Yong-Fa; Gao, Si-Fa; Xu, Xi-Ming; Ge, Wei

2017-01-01

Objective Transcatheter arterial chemoembolization (TACE) and thalidomide have been used for treating primary hepatocellular carcinoma(HCC). This study aims to evaluate the clinical efficacy and safety of thalidomide and TACE in primary HCC. Methods Randomized controlled trials(RCTs) about efficacy and safety of thalidomide combined with TACE for primary HCC were identified from the Cochrane Library, Pubmed, Embase, CNKI, and Wan Fang until August, 2016. The retrieved trials were reviewed and the data were extracted by two reviewers, independently. Combined analyses of survival rates, overall response rate(ORR), disease control rate(DCR), changes of KPS, parameters of cellular immunity and vascular endothelial growth factor(VEGF), and adverse events were performed using RevMan 5.3 software. Results A total of 23 RCTs involving 1836 patients were included. The results showed that thalidomide plus TACE was significantly superior in increasing 6-month survival rate(OR=1.79, 95% CI:1.02-3.15, P=0.04), 1-year survival rate(OR=1.76, 95% CI:1.38-2.24, P<0.0001), 1.5-year survival rate(OR=4.72, 95% CI:2.64-8.43, P<0.001), 2-year survival rate(OR=1.78, 95% CI:1.37-2.30, P<0.001), ORR(OR=1.89, 95% CI:1.48-2.42, P<0.0001), DCR(OR=2.62, 95% CI:1.90-3.63, P<0.001), improvement in cellular immunity(MD=0.63, 95% CI:0.45-0.80, P<0.0001), and reduction of VEGF(MD=-119.71, 95% CI:-135.75—103.68, P<0.0001), when compared with TACE group. The incidences of gastrointestinal reactions, myelosuppression, and liver dysfunction were similar between combination group and TACE group(P>0.05). However, compared to TACE, the combination of thalidomide and TACE had a higher incidence of drug rash(OR=6.35, 95% CI:2.75-14.68, P<0.0001). Conclusion Our findings suggest that thalidomide combined with TACE shows better clinical efficacy and tolerable adverse events in patients with primary HCC when compared with TACE alone. PMID:28402958

"I Didn't Always Perceive Myself as a "Science Person"": Examining Efficacy for Primary Science Teaching

ERIC Educational Resources Information Center

Mansfield, Caroline F.; Woods-McConney, Amanda

2012-01-01

Teacher efficacy has become an important field of research especially in subjects teachers may find challenging, such as science. This study investigates the sources of teachers' efficacy for teaching science in primary schools in the context of authentic teaching situations with a view to better understanding sources of teachers' efficacy…

Irreversible Electroporation (IRE) Fails to Demonstrate Efficacy in a Prospective Multicenter Phase II Trial on Lung Malignancies: The ALICE Trial

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ricke, Jens, E-mail: jens.ricke@med.ovgu.de; Jürgens, Julian H. W., E-mail: julian.juergens@med.ovgu.de; Deschamps, Frederic

2015-04-15

PurposeTo assess safety and efficacy of irreversible electroporation (IRE) of lung malignancies.Materials and MethodsPatients with primary and secondary lung malignancies and preserved lung function were included in this prospective single arm trial. Primary and secondary endpoints were safety and efficacy. Recruitment goal was 36 subjects in 2 centers. Patients underwent IRE under general anesthesia with probe placement performed in Fluoroscopy-CT. The IRE system employed was NanoKnife{sup ®} (Angiodynamics). System settings for the ablation procedure followed the manufacturer’s recommendations. The Mann–Whitney U test was used to evaluate the correlation of nine technical parameters with local tumor control. Median follow up wasmore » 12 months.ResultsThe expected efficacy was not met at interim analysis and the trial was stopped prematurely after inclusion of 23 patients (13/10 between both centers). The dominant tumor entity was colorectal (n = 13). The median tumor diameter was 16 mm (8–27 mm). Pneumothoraces were observed in 11 of 23 patients with chest tubes required in 8 (35 %). Frequently observed alveolar hemorrhage never led to significant hemoptysis. 14/23 showed progressive disease (61 %). Stable disease was found in 1 (4 %), partial remission in 1 (4 %) and complete remission in 7 (30 %) patients. The relative increase of the current during ablation was significantly higher in the group treated successfully as compared to the group presenting local recurrence (p < 0.05). Needle tract seeding was found in three cases (13 %).ConclusionsIRE is not effective for the treatment of lung malignancies. We hypothesize that the energy deposition with current IRE probes is highly sensitive to air exposure.« less

Safety and efficacy of a freeze-dried trivalent antivenom for snakebites in the Brazilian Amazon: An open randomized controlled phase IIb clinical trial

PubMed Central

Mendonça-da-Silva, Iran; Magela Tavares, Antônio; Sachett, Jacqueline; Sardinha, José Felipe; Zaparolli, Lilian; Gomes Santos, Maria Fátima; Lacerda, Marcus

2017-01-01

Background In tropical areas, a major concern regarding snakebites treatment effectiveness relates to the failure in liquid antivenom (AV) distribution due to the lack of an adequate cold chain in remote areas. To minimize this problem, freeze-drying has been suggested to improve AV stability. Methods and findings This study compares the safety and efficacy of a freeze-dried trivalent antivenom (FDTAV) and the standard liquid AV provided by the Brazilian Ministry of Health (SLAV) to treat Bothrops, Lachesis and Crotalus snakebites. This was a prospective, randomized, open, phase IIb trial, carried out from June 2005 to May 2008 in the Brazilian Amazon. Primary efficacy endpoints were the suppression of clinical manifestations and return of hemostasis and renal function markers to normal ranges within the first 24 hours of follow-up. Primary safety endpoint was the presence of early adverse reactions (EAR) in the first 24 hours after treatment. FDTAV thermal stability was determined by estimating AV potency over one year at 56°C. Of the patients recruited, 65 and 51 were assigned to FDTAV and SLAV groups, respectively. Only mild EARs were reported, and they were not different between groups. There were no differences in fibrinogen (p = 0.911) and clotting time (p = 0.982) recovery between FDTAV and SLAV treated groups for Bothrops snakebites. For Lachesis and Crotalus snakebites, coagulation parameters and creatine phosphokinase presented normal values 24 hours after AV therapy for both antivenoms. Conclusions/Significance Since promising results were observed for efficacy, safety and thermal stability, our results indicate that FDTAV is suitable for a larger phase III trial. Trial registration ISRCTNregistry: ISRCTN12845255; DOI: 10.1186/ISRCTN12845255 (http://www.isrctn.com/ISRCTN12845255). PMID:29176824

Safety and efficacy of a freeze-dried trivalent antivenom for snakebites in the Brazilian Amazon: An open randomized controlled phase IIb clinical trial.

PubMed

Mendonça-da-Silva, Iran; Magela Tavares, Antônio; Sachett, Jacqueline; Sardinha, José Felipe; Zaparolli, Lilian; Gomes Santos, Maria Fátima; Lacerda, Marcus; Monteiro, Wuelton Marcelo

2017-11-01

In tropical areas, a major concern regarding snakebites treatment effectiveness relates to the failure in liquid antivenom (AV) distribution due to the lack of an adequate cold chain in remote areas. To minimize this problem, freeze-drying has been suggested to improve AV stability. This study compares the safety and efficacy of a freeze-dried trivalent antivenom (FDTAV) and the standard liquid AV provided by the Brazilian Ministry of Health (SLAV) to treat Bothrops, Lachesis and Crotalus snakebites. This was a prospective, randomized, open, phase IIb trial, carried out from June 2005 to May 2008 in the Brazilian Amazon. Primary efficacy endpoints were the suppression of clinical manifestations and return of hemostasis and renal function markers to normal ranges within the first 24 hours of follow-up. Primary safety endpoint was the presence of early adverse reactions (EAR) in the first 24 hours after treatment. FDTAV thermal stability was determined by estimating AV potency over one year at 56°C. Of the patients recruited, 65 and 51 were assigned to FDTAV and SLAV groups, respectively. Only mild EARs were reported, and they were not different between groups. There were no differences in fibrinogen (p = 0.911) and clotting time (p = 0.982) recovery between FDTAV and SLAV treated groups for Bothrops snakebites. For Lachesis and Crotalus snakebites, coagulation parameters and creatine phosphokinase presented normal values 24 hours after AV therapy for both antivenoms. Since promising results were observed for efficacy, safety and thermal stability, our results indicate that FDTAV is suitable for a larger phase III trial. ISRCTNregistry: ISRCTN12845255; DOI: 10.1186/ISRCTN12845255 (http://www.isrctn.com/ISRCTN12845255).

A 3-year Randomized Therapeutic Trial of Nitisinone in Alkaptonuria

PubMed Central

Introne, Wendy J.; Perry, Monique B.; Troendle, James; Tsilou, Ekaterini; Kayser, Michael A.; Suwannarat, Pim; O’Brien, Kevin E.; Bryant, Joy; Sachdev, Vandana; Reynolds, James C.; Moylan, Elizabeth; Bernardini, Isa; Gahl, William A.

2011-01-01

Alkaptonuria is a rare, autosomal recessive disorder of tyrosine degradation due to deficiency of the third enzyme in the catabolic pathway. As a result, homogentisic acid (HGA) accumulates and is excreted in gram quantities in the urine, which turns dark upon alkalization. The first symptoms, occurring in early adulthood, involve a painful, progressively debilitating arthritis of the spine and large joints. Cardiac valvular disease and renal and prostate stones occur later. Previously suggested therapies have failed to show benefit, and management remains symptomatic. Nitisinone, a potent inhibitor of the second enzyme in the tyrosine catabolic pathway, is considered a potential therapy; proof-of-principle studies showed 95% reduction in urinary HGA. Based on those findings, a prospective, randomized clinical trial was initiated in 2005 to evaluate 40 patients over a 36-month period. The primary outcome parameter was hip total range of motion with measures of musculoskeletal function serving as secondary parameters. Biochemically, this study consistently demonstrated 95% reduction of HGA in urine and plasma over the course of 3 years. Clinically, primary and secondary parameters did not prove benefit from the medication. Side effects were infrequent. This trial illustrates the remarkable tolerability of nitisinone, its biochemical efficacy, and the need to investigate its use in younger individuals prior to development of debilitating arthritis. PMID:21620748

A 3-year randomized therapeutic trial of nitisinone in alkaptonuria.

PubMed

Introne, Wendy J; Perry, Monique B; Troendle, James; Tsilou, Ekaterini; Kayser, Michael A; Suwannarat, Pim; O'Brien, Kevin E; Bryant, Joy; Sachdev, Vandana; Reynolds, James C; Moylan, Elizabeth; Bernardini, Isa; Gahl, William A

2011-08-01

Alkaptonuria is a rare, autosomal recessive disorder of tyrosine degradation due to deficiency of the third enzyme in the catabolic pathway. As a result, homogentisic acid (HGA) accumulates and is excreted in gram quantities in the urine, which turns dark upon alkalization. The first symptoms, occurring in early adulthood, involve a painful, progressively debilitating arthritis of the spine and large joints. Cardiac valvular disease and renal and prostate stones occur later. Previously suggested therapies have failed to show benefit, and management remains symptomatic. Nitisinone, a potent inhibitor of the second enzyme in the tyrosine catabolic pathway, is considered a potential therapy; proof-of-principle studies showed 95% reduction in urinary HGA. Based on those findings, a prospective, randomized clinical trial was initiated in 2005 to evaluate 40 patients over a 36-month period. The primary outcome parameter was hip total range of motion with measures of musculoskeletal function serving as secondary parameters. Biochemically, this study consistently demonstrated 95% reduction of HGA in urine and plasma over the course of 3 years. Clinically, primary and secondary parameters did not prove benefit from the medication. Side effects were infrequent. This trial illustrates the remarkable tolerability of nitisinone, its biochemical efficacy, and the need to investigate its use in younger individuals prior to development of debilitating arthritis. Published by Elsevier Inc.

Pulse duration settings in subthalamic stimulation for Parkinson's disease

PubMed Central

Steigerwald, Frank; Timmermann, Lars; Kühn, Andrea; Schnitzler, Alfons; Reich, Martin M.; Kirsch, Anna Dalal; Barbe, Michael Thomas; Visser‐Vandewalle, Veerle; Hübl, Julius; van Riesen, Christoph; Groiss, Stefan Jun; Moldovan, Alexia‐Sabine; Lin, Sherry; Carcieri, Stephen; Manola, Ljubomir

2017-01-01

ABSTRACT Background Stimulation parameters in deep brain stimulation (DBS) of the subthalamic nucleus for Parkinson's disease (PD) are rarely tested in double‐blind conditions. Evidence‐based recommendations on optimal stimulator settings are needed. Results from the CUSTOM‐DBS study are reported, comparing 2 pulse durations. Methods A total of 15 patients were programmed using a pulse width of 30 µs (test) or 60 µs (control). Efficacy and side‐effect thresholds and unified PD rating scale (UPDRS) III were measured in meds‐off (primary outcome). The therapeutic window was the difference between patients’ efficacy and side effect thresholds. Results The therapeutic window was significantly larger at 30 µs than 60 µs (P = ·0009) and the efficacy (UPDRS III score) was noninferior (P = .00008). Interpretation Subthalamic neurostimulation at 30 µs versus 60 µs pulse width is equally effective on PD motor signs, is more energy efficient, and has less likelihood of stimulation‐related side effects. © 2017 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society. PMID:29165837

Assessments of quaternary ammonium compounds (QAC) for in-water treatment of mussel fouling in vessel internals and sea chests using an experimental seawater pipework system.

PubMed

Piola, Richard; Grandison, Clare

2017-01-01

The primary in-water emergency treatment method for mussel fouling of internal seawater systems of Royal Australian Navy vessels is to flush with a 1% detergent solution containing quaternary ammonium compounds (QAC). Parameters for application of this treatment are based on previous research; however, much of the research has been conducted at small-scales under controlled laboratory conditions. This study examined the efficacy of QAC solutions for treating mussel biofouling under realistic field conditions using experimental seawater piping systems. The efficacy of QAC solutions was highly dependent on the size of mussels present. Chemical treatments comprising 1, 2 and 5% v v -1 QAC solution were effective at killing large (50-92 mm) mussels in the pipework and sea chest of the system following 24 h exposure. In contrast, small mussels (10-30 mm) appeared resilient to the majority of treatment regimes. Differences in water temperature, DO and pH during dosing had no discernible impact on treatment efficacy.

Biosimilarity and Interchangeability: Principles and Evidence: A Systematic Review.

PubMed

McKinnon, Ross A; Cook, Matthew; Liauw, Winston; Marabani, Mona; Marschner, Ian C; Packer, Nicolle H; Prins, Johannes B

2018-02-01

The efficacy, safety and immunogenicity risk of switching between an originator biologic and a biosimilar or from one biosimilar to another are of potential concern. The aim was to conduct a systematic literature review of the outcomes of switching between biologics and their biosimilars and identify any evidence gaps. A systematic literature search was conducted in PubMed, EMBASE and Cochrane Library from inception to June 2017. Relevant societal meetings were also checked. Peer-reviewed studies reporting efficacy and/or safety data on switching between originator and biosimilar products or from one biosimilar to another were selected. Studies with fewer than 20 switched patients were excluded. Data were extracted on interventions, study population, reason for treatment switching, efficacy outcomes, safety and anti-drug antibodies. The systematic literature search identified 63 primary publications covering 57 switching studies. The reason for switching was reported as non-medical in 50 studies (23 clinical, 27 observational). Seven studies (all observational) did not report whether the reasons for switching were medical or non-medical. In 38 of the 57 studies, fewer than 100 patients were switched. Follow-up after switching went beyond 1 year in eight of the 57 studies. Of the 57 studies, 33 included statistical analysis of disease activity or patient outcomes; the majority of these studies found no statistically significant differences between groups for main efficacy parameters (based on P < 0.05 or predefined acceptance ranges), although some studies observed changes for some parameters. Most studies reported similar safety profiles between groups. There are important evidence gaps around the safety of switching between biologics and their biosimilars. Sufficiently powered and appropriately statistically analysed clinical trials and pharmacovigilance studies, with long-term follow-ups and multiple switches, are needed to support decision-making around biosimilar switching.

Are multisource levothyroxine sodium tablets marketed in Egypt interchangeable?

PubMed

Abou-Taleb, Basant A; Bondok, Maha; Nounou, Mohamed Ismail; Khalafallah, Nawal; Khalil, Saleh

2018-02-01

A clinical study was initiated in response to patients' complaints, supported by the treating physicians, of suspected differences in efficacy among multisource levothyroxine sodium tablets marketed in Egypt. The study design was a multiple dose (100μg levothyroxine sodium tablet once daily for 6 months) and involved 50 primary hypothyroidism female patients (5 equal groups). Tablets administered included five tablet batches (two brands, three origin locations) purchased from local pharmacies in Alexandria. Assessment parameters (measured on consecutive visits) included the thyroid stimulating hormone, total and free levothyroxine. Tablet dissolution rate was determined (BP/EP 2014 & USP 2014). In vitro vs in vivovs correlations were developed. Clinical and pharmaceutical data confirmed inter-brand and inter-source differences in efficacy. Correlations examined indicated potential usefulness of in vitro dissolution test in detecting poor performing levothyroxine sodium tablets during shelf life. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Teacher Self-Efficacy: A Link to Student Achievement in English Language and Mathematics in Belizean Primary Schools

ERIC Educational Resources Information Center

Alvarez-Nunez, Tanya Mae

2012-01-01

Scope and Method of Study: This quantitative, non-experimental study sought to determine if a statistically significant difference existed in student achievement on the PSE exam in Belizean primary schools for students who have teachers with varying levels of self-efficacy (high, medium and low). The Teacher Efficacy Scale (TES), which captures…

Measuring Pre-Service Teachers' Self-Efficacy in Tutoring Children in Primary Mathematics: An Instrument

ERIC Educational Resources Information Center

Bjerke, Annette Hessen; Eriksen, Elisabeta

2016-01-01

This article reports on the use of Rasch modelling to develop and validate an instrument measuring self-efficacy in tutoring children in primary mathematics (SETcPM). In response to the literature on teacher efficacy, the 20-item instrument aims to inform teacher educators, and is designed for novice pre-service teachers (nPSTs) preparing to teach…

Measuring Technological and Content Knowledge of Undergraduate Primary Teachers in Mathematics

NASA Astrophysics Data System (ADS)

Doukakis, Spyros; Chionidou-Moskofoglou, Maria; Mangina-Phelan, Eleni; Roussos, Petros

Twenty-five final-year undergraduate students of primary education who were attending a course on mathematics education participated in a research project during the 2009 spring semester. A repeated measures experimental design was used. Quantitative data on students' computer attitudes, self-efficacy in ICT, attitudes toward educational software, and self-efficacy in maths were collected. Data analysis showed a statistically non-significant improvement on participants' computer attitudes and self-efficacy in ICT and ES, but a significant improvement of self-efficacy in mathematics.

Self-Efficacy, School Resources, Job Stressors and Burnout among Spanish Primary and Secondary School Teachers: A Structural Equation Approach

ERIC Educational Resources Information Center

Betoret, Fernando Domenech

2009-01-01

This study examines the relationship between school resources, teacher self-efficacy, potential multi-level stressors and teacher burnout using structural equation modelling. The causal structure for primary and secondary school teachers was also examined. The sample was composed of 724 primary and secondary Spanish school teachers. The changes…

Safety and efficacy of a traditional herbal medicine (Throat Coat) in symptomatic temporary relief of pain in patients with acute pharyngitis: a multicenter, prospective, randomized, double-blinded, placebo-controlled study.

PubMed

Brinckmann, Josef; Sigwart, Herbert; van Houten Taylor, Leslie

2003-04-01

To investigate the safety and efficacy of Throat Coat) (Traditional Medicinals,) Sebastopol, CA), a traditional demulcent herbal tea, in comparison with a placebo tea in the symptomatic treatment of acute pharyngitis. Multicenter, prospective, randomized, double-blinded, placebo-controlled, two-armed, parallel-group clinical trial. Three primary care clinics in Duluth, MN, Madison, WI, and Middleton, WI. Patients of both genders (>or=18 years of age) with clinical diagnoses of acute pharyngitis. Patients (n = 60) were randomly assigned to receive 5-8 oz of Throat Coat (n = 30) or a placebo (n = 30), four to six times daily. The study period was 2 to 7 days with a window for the follow-up visit of 2-10 days accounting for the variable duration of sore throat symptoms. Primary efficacy parameter: sum of pain intensity differences (SPID) for pain in throat on swallowing, calculated as the area under the curve (AUC) of pain intensity difference scores (assessed at 1 minute, 5 minutes, 10 minutes, 15 minutes, 20 minutes, and 30 minutes after treatment). Secondary efficacy parameter: total pain relief (TOTPAR), calculated as the AUC from time 0 (baseline) to 30 minutes of pain relief (assessed at 1 minute, 5 minutes, 10 minutes, 15 minutes, 20 minutes, and 30 minutes). Compared to placebo, intensity of throat pain when swallowing was significantly reduced by Throat Coat in intention to treat and valid for efficacy analysis (VEA). Significant differences in change from baseline pain were observed at 5 min (p = 0.007), 10 min (p = 0.005), 15 minutes (p = 0.01), 20 minutes (p = 0.05), and 30 minutes (p = 0.04) after completion of the first dose (VEA analysis). There was a statistically significant improvement of SPID in the Throat Coat-treated group: Least square means +/- standard error of the means (SEM) of SPID were -16.5 +/- 13.9 in the placebo group and -43.8 +/- 11.9 in the Throat Coat-treated group (p = 0.012). TOTPAR was also significantly higher in the Throat Coat-treated group: Least square means +/- SEM of TOTPAR were 32.4 +/- 12.8 in the placebo group and 53.6 +/- 10.9 in the Throat Coat-treated group (p = 0.031). This study shows that Throat Coat is significantly superior to placebo and provided a rapid, temporary relief of sore throat pain in patients with pharyngitis.

Quantifying Therapeutic and Diagnostic Efficacy in 2D Microvascular Images

NASA Technical Reports Server (NTRS)

Parsons-Wingerter, Patricia; Vickerman, Mary B.; Keith, Patricia A.

2009-01-01

VESGEN is a newly automated, user-interactive program that maps and quantifies the effects of vascular therapeutics and regulators on microvascular form and function. VESGEN analyzes two-dimensional, black and white vascular images by measuring important vessel morphology parameters. This software guides the user through each required step of the analysis process via a concise graphical user interface (GUI). Primary applications of the VESGEN code are 2D vascular images acquired as clinical diagnostic images of the human retina and as experimental studies of the effects of vascular regulators and therapeutics on vessel remodeling.

Relationship between self-efficacy, self-care behaviour and glycaemic control among patients with type 2 diabetes mellitus in the Malaysian primary care setting.

PubMed

Tharek, Zahirah; Ramli, Anis Safura; Whitford, David Leonard; Ismail, Zaliha; Mohd Zulkifli, Maryam; Ahmad Sharoni, Siti Khuzaimah; Shafie, Asrul Akmal; Jayaraman, Thevaraajan

2018-03-09

Self-efficacy has been shown to be positively correlated with self-care behaviour and glycaemic control among patients with type 2 diabetes mellitus. However, such evidence is lacking in the Malaysian primary care setting. The objectives of this study were to i) determine the levels of self-efficacy, self-care behaviour and glycaemic control among patients with type 2 diabetes mellitus in the Malaysian primary care setting ii) determine the relationship between self-efficacy, self-care behaviour and glycaemic control iii) determine the factors associated with glycaemic control. This was a cross-sectional study involving patients with type 2 diabetes mellitus from two public primary care clinics in Malaysia. Self-efficacy and self-care behaviour levels were measured using previously translated and validated DMSES and SDSCA questionnaires in Malay versions, respectively. Glycaemic control was measured using HbA 1c. RESULTS: A total of 340 patients with type 2 diabetes mellitus were recruited. The total mean (±SD) of self-efficacy and self-care behaviour scores were 7.33 (±2.25) and 3.76 (±1.87), respectively. A positive relationship was found between self-efficacy and self-care behaviour (r 0.538, P < 0.001). Higher self-efficacy score was shown to be correlated with lower HbA 1c (r - 0.41, P < 0.001). Multiple linear regression analysis demonstrated that higher self-efficacy scores (b - 0.398; 95% CI: -0.024, - 0.014; P < 0.001), shorter duration of diabetes (b 0.177; 95% CI: 0.002, 0.007; P < 0.001) and smaller waist circumference (b 0.135; 95% CI: 0.006, 0.035; P = 0.006), were significantly associated with good glycaemic control. This study demonstrated that higher self-efficacy was correlated with improved self-care behaviour and better glycaemic control. Findings of this study suggest the importance of including routine use of self-efficacy measures in the management of type 2 diabetes mellitus in primary care.

Preemptive versus postoperative lumiracoxib for analgesia in ambulatory arthroscopic knee surgery

PubMed Central

Grifka, Joachim; Enz, Rudolf; Zink, Joachim; Hugot, Jean Louis; Kreiss, Andreas; Arulmani, Udayasankar; Yu, Vincent; Rebuli, Rosemary; Krammer, Gerhard

2008-01-01

We compared the efficacy and safety of preemptive vs postoperative dosing of lumiracoxib 400 mg in patients undergoing minor ambulatory arthroscopic knee surgery. Eligible patients were randomized to preemptive lumiracoxib, postoperative lumiracoxib, and placebo. The main efficacy parameter was pain intensity (PI) (0–100 mm visual analog scale) in the target knee upon movement, 2 hours after surgery. Other efficacy variables included PI in the target knee at rest and upon movement at 1, 3, 4, and 24 hours, time to first rescue medication intake. In the lumiracoxib preemptive and postoperative groups, the estimated treatment difference compared to placebo for primary endpoint was −4.0 (95% CI: −9, −1; p = 0.007) and −3.5 (95% CI: −8.5, 0; p = 0.052), respectively. There was no statistical significant difference between two active treatment groups (p = 0.602). Both preemptive and postoperative lumiracoxib resulted in significantly lower PI scores at rest and after movement at all time-points and no statistically significant difference was observed between the active treatments. Time to rescue medication intake was comparable for both active treatments. The proportion of adverse events was similar among all groups. We conclude that the efficacy of lumiracoxib 400 mg is not affected by the timing of administration (preemptive or postoperative). PMID:21197285

The Role of Practitioner Self-Efficacy, Training, Program and Workplace Factors on the Implementation of an Evidence-Based Parenting Intervention in Primary Care

ERIC Educational Resources Information Center

Turner, Karen M. T.; Nicholson, Jan M.; Sanders, Matthew R.

2011-01-01

This study examines factors affecting the implementation by primary care practitioners (nursing, education, allied health, and medical) of a brief parenting and family support intervention (the Primary Care Triple P--Positive Parenting Program) following professional training. It assesses the impact of prior experience, self-efficacy, program…

Examination of the Self-Efficacy of Primary School Teacher Candidates towards First Reading-Writing Education

ERIC Educational Resources Information Center

Bayraktar, Hatice Vatansever

2016-01-01

The aim of this study is to examine the levels of the self-efficacy of primary school teacher candidates towards first reading-writing education and whether they differentiate by various variables. The study is prepared in accordance with the screening model. The universe of this study consists of the primary school teacher candidates who receive…

From Students to Teachers: Investigating the Science Teaching Efficacy Beliefs and Experiences of Graduate Primary Teachers

NASA Astrophysics Data System (ADS)

Deehan, James; Danaia, Lena; McKinnon, David H.

2018-03-01

The science achievement of primary students, both in Australia and abroad, has been the subject of intensive research in recent decades. Consequently, much research has been conducted to investigate primary science education. Within this literature, there is a striking juxtaposition between tertiary science teaching preparation programs and the experiences and outcomes of both teachers and students alike. Whilst many tertiary science teaching programs covary with positive outcomes for preservice teachers, reports of science at the primary school level continue to be problematic. This paper begins to explore this apparent contradiction by investigating the science teaching efficacy beliefs and experiences of a cohort of graduate primary teachers who had recently transitioned from preservice to inservice status. An opportunity sample of 82 primary teachers responded to the science teaching efficacy belief instrument A (STEBI-A), and 10 graduate teachers provided semi-structured interview data. The results showed that participants' prior science teaching efficacy belief growth, which occurred during their tertiary science education, had remained durable after they had completed their teaching degrees and began their careers. Qualitative data showed that their undergraduate science education had had a positive influence on their science teaching experiences. The participants' school science culture, however, had mixed influences on their science teaching. The findings presented within this paper have implications for the direction of research in primary science education, the design and assessment of preservice primary science curriculum subjects and the role of school contexts in the development of primary science teachers.

Self Efficacy and Some Demographic Variables as Predictors of Occupational Stress among Primary School Teachers in Delta State of Nigeria

ERIC Educational Resources Information Center

Akpochafo, G. O.

2014-01-01

This study investigated self efficacy and some demographic variables as predictors of occupational stress among primary school teachers in Delta State. Three hypotheses were formulated to guide the study. The study adopted a descriptive survey design that utilized an expost-facto research type. A sample of one hundred and twenty primary school…

"It's Important to Put Yourself in Any Lesson That You Teach": Self-Efficacy in Action in the Primary Modern Foreign Languages Classroom

ERIC Educational Resources Information Center

Pattison, Elaine Margaret

2014-01-01

This article explores how Bourdieu's notion of "habitus" might be employed to shed light on the self-efficacy of primary teachers as they take on an additional specialism when modern foreign languages becomes statutory in primary schools in the new English National Curriculum in 2014. The article argues that Bandura's four principles of…

On-demand tramadol hydrochloride use in premature ejaculation treatment.

PubMed

Kaynar, Mehmet; Kilic, Ozcan; Yurdakul, Talat

2012-01-01

To determine the efficacy of tramadol in premature ejaculation (PE) treatment compared with placebo. A single-blind, placebo-controlled, crossover study was conducted with 60 lifelong (primary) patients with PE. The patients were randomized into 2 groups, each consisting of 30 patients, who took tramadol or placebo on demand. PE was defined as an intravaginal ejaculation latency time of ≤60 seconds in 90% of intercourse episodes. The efficacy of the drugs was assessed using the intravaginal ejaculation latency time, ability of ejaculation control, and sexual satisfaction scores after an 8-week treatment period. All participants completed the study voluntarily. Two groups were similar in terms of the patient demographics. Increases in the intravaginal ejaculation latency time, ability of ejaculation control, and sexual satisfaction score between the placebo and tramadol groups were compared with the baseline values in both groups. At the end of study period, the tramadol group had significantly (P<.001) greater values for all 3 parameters compared with those in the placebo group. On-demand use of low-dose tramadol is effective for lifelong PE. Currently, selective seratonin reuptake inhibitors such as dapoxetine, are a more popular treatment option for PE. However, tramadol might be considered an alternative agent for primary PE treatment. Copyright © 2012 Elsevier Inc. All rights reserved.

A randomised study of perioperative esmolol infusion for haemodynamic stability during major vascular surgery; rationale and design of DECREASE-XIII.

PubMed

Bakker, E J; Ravensbergen, N J; Voute, M T; Hoeks, S E; Chonchol, M; Klimek, M; Poldermans, D

2011-09-01

This article describes the rationale and design of the DECREASE-XIII trial, which aims to evaluate the potential of esmolol infusion, an ultra-short-acting beta-blocker, during surgery as an add-on to chronic low-dose beta-blocker therapy to maintain perioperative haemodynamic stability during major vascular surgery. A double-blind, placebo-controlled, randomised trial. A total of 260 vascular surgery patients will be randomised to esmolol or placebo as an add-on to standard medical care, including chronic low-dose beta-blockers. Esmolol is titrated to maintain a heart rate within a target window of 60-80 beats per minute for 24 h from the induction of anaesthesia. Heart rate and ischaemia are assessed by continuous 12-lead electrocardiographic monitoring for 72 h, starting 1 day prior to surgery. The primary outcome measure is duration of heart rate outside the target window during infusion of the study drug. Secondary outcome measures will be the efficacy parameters of occurrence of cardiac ischaemia, troponin T release, myocardial infarction and cardiac death within 30 days after surgery and safety parameters such as the occurrence of stroke and hypotension. This study will provide data on the efficacy of esmolol titration in chronic beta-blocker users for tight heart-rate control and reduction of ischaemia in patients undergoing vascular surgery as well as data on safety parameters. Copyright © 2011 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

Rotigotine improves restless legs syndrome: a 6-month randomized, double-blind, placebo-controlled trial in the United States.

PubMed

Hening, Wayne A; Allen, Richard P; Ondo, William G; Walters, Arthur S; Winkelman, John W; Becker, Philip; Bogan, Richard; Fry, June M; Kudrow, David B; Lesh, Kurt W; Fichtner, Andreas; Schollmayer, Erwin

2010-08-15

This randomized, double-blinded, placebo-controlled trial (NCT00135993) assessed efficacy and safety of the dopamine agonist rotigotine in the treatment of idiopathic restless legs syndrome (RLS) over a 6-month maintenance period. A total of 505 eligible participants with moderate to severe RLS (IRLS sum score >or= 15) were randomly assigned to five groups to receive either placebo or rotigotine (0.5, 1, 2, or 3 mg/24 hr) delivered by once-daily transdermal patch (fixed-dose regimen). The two co-primary efficacy parameters decreased from baseline to end of maintenance in IRLS sum score and in clinical global impressions (CGI-1) score. On both primary measures, 2 and 3 mg/24 hr rotigotine was superior to placebo (P < 0.001). Adjusted treatment differences to placebo for the IRLS sum score were -4.5 (95% CI: -6.9, -2.2) for 2 mg/24 hr rotigotine, -5.2 (95% CI: -7.5, -2.9) for 3 mg/24 hr rotigotine, and for CGI item 1 -0.65 (95% CI: -1.0, -0.3) and -0.9 (95% CI: -1.3, -0.5) for the 2 and 3 mg/24 hr doses, respectively. Skin reactions (27%) and known dopaminergic side effects such as nausea (18.1%) and headache (11.6%) were mostly mild or moderate in rotigotine subjects. Rotigotine transdermal patches releasing 2 to 3 mg/24 hr significantly reduced the severity of RLS symptoms. Treatment efficacy was maintained throughout the 6-month double-blind period.

Teachers' work ability: a study of relationships between collective efficacy and self-efficacy beliefs.

PubMed

Guidetti, Gloria; Viotti, Sara; Bruno, Andreina; Converso, Daniela

2018-01-01

Work ability constitutes one of the most studied well-being indicators related to work. Past research highlighted the relationship with work-related resources and demands, and personal resources. However, no studies highlight the role of collective and self-efficacy beliefs in sustaining work ability. The purpose of this study was to examine whether and by which mechanism work ability is linked with individual and collective efficacies in a sample of primary and middle school teachers. Using a dataset consisting of 415 primary and middle school Italian teachers, the analysis tested for the mediating role of self-efficacy between collective efficacy and work ability. Mediational analysis highlights that teachers' self-efficacy totally mediates the relationship between collective efficacy and perceived work ability. Results of this study enhance the theoretical knowledge and empirical evidence regarding the link between teachers' collective efficacy and self-efficacy, giving further emphasis to the concept of collective efficacy in school contexts. Moreover, the results contribute to the study of well-being in the teaching profession, highlighting a process that sustains and promotes levels of work ability through both collective and personal resources.

Progression-free survival: gaining on overall survival as a gold standard and accelerating drug development.

PubMed

Lebwohl, David; Kay, Andrea; Berg, William; Baladi, Jean Francois; Zheng, Ji

2009-01-01

In clinical trials of oncology drugs, overall survival (OS) is a direct measure of clinical efficacy and is considered the gold standard primary efficacy end point. The purpose of this study was to discuss the difficulties in using OS as a primary efficacy end point in the setting of evolving cancer therapies. We suggest that progression-free survival is an appropriate efficacy end point in many types of cancer, specifically those for which OS is expected to be prolonged and for which subsequent treatments are expected to affect OS.

Feasibility and Preliminary Efficacy of the Fit4Fun Intervention for Improving Physical Fitness in a Sample of Primary School Children: A Pilot Study

ERIC Educational Resources Information Center

Eather, Narelle; Morgan, Philip J.; Lubans, David R.

2013-01-01

Objective: The primary objective of this study was to evaluate the feasibility and preliminary efficacy of a school-based physical fitness intervention (Fit4Fun) on the physical fitness and physical activity (PA) levels of primary school children. Methods: A group-randomized controlled trial with a 3-month wait-list control group was conducted in…

Safety and Efficacy of Glucomannan for Weight Loss in Overweight and Moderately Obese Adults

PubMed Central

Keithley, Joyce K.; Swanson, Barbara; Mikolaitis, Susan L.; DeMeo, Mark; Zeller, Janice M.; Fogg, Lou; Adamji, Jehan

2013-01-01

Background. Few safe and effective dietary supplements are available to promote weight loss. We evaluated the safety and efficacy of glucomannan, a water-soluble fiber supplement, for achieving weight loss in overweight and moderately obese individuals consuming self-selected diets. Methods. Participants were randomly assigned to take 1.33 grams of glucomannan or identically looking placebo capsules with 236.6 mL (8 ounces) of water one hour before breakfast, lunch, and dinner for 8 weeks. The primary efficacy outcome was change in body weight after 8 weeks. Other efficacy outcomes were changes in body composition, hunger/fullness, and lipid and glucose concentrations. Safety outcomes included gastrointestinal symptoms/tolerance and serum liver enzymes and creatinine levels. Results. A total of 53 participants (18–65 years of age; BMI 25–35 kg/m2) were enrolled and randomized. The two groups did not differ with respect to baseline characteristics and compliance with the study supplement. At 8 weeks, there was no significant difference between the glucomannan and placebo groups in amount of weight loss (−.40 ± .06 and −.43 ± .07, resp.) or other efficacy outcomes or in any of the safety outcomes. Conclusions. Glucomannan supplements administered over 8 weeks were well tolerated but did not promote weight loss or significantly alter body composition, hunger/fullness, or lipid and glucose parameters. This trial is registered with NCT00613600. PMID:24490058

Topical symphytum herb concentrate cream against myalgia: a randomized controlled double-blind clinical study.

PubMed

Kucera, Miroslav; Barna, Milos; Horàcek, Ondrej; Kàlal, Jan; Kucera, Alexander; Hladìkova, Marie

2005-01-01

The effectiveness and tolerability of the topical Symphytum product Traumaplant (Harras Pharma Curarina, München, Germany) (10% active ingredient of a 2.5:1 aqueous-ethanolic pressed concentrate of freshly harvested, cultivated comfrey herb [Symphytum uplandicum Nyman], corresponding to 25 g of fresh herb per 100 g of cream) in the treatment of patients with myalgia (n=104) were tested against a 1% reference product (corresponding to 2.5 g of fresh comfrey herb in 100 g of cream; n=111). The primary efficacy parameter in this double-blind, reference- controlled, randomized, multicenter study of 215 patients with pain in the lower and upper back was pain in motion, assessed with the aid of a visual analogue scale. Secondary efficacy parameters included pain at rest, pain on palpation, and functional impairment. With high concentrations of the treatment product, amelioration of pain on active motion (P<5 x 10 -9 ), pain at rest (P<.001), and pain on palpation (P=5 x 10 -5 ) was significantly more pronounced than that attained with the reference product and was clinically highly relevant. A number needed to treat of 3.2 was calculated from the study results. Global efficacy was significantly better (P=1 x 10 -8 ) and onset of effects was faster (P=4 x 10 -7 ) with the high-concentration product. Tolerability of the highly concentrated study product was good to excellent in all patients. Study results confirm the known anti-inflammatory and analgesic effects of topical (Symphytum cream. As a new finding, applicability in certain forms of back pain can be concluded.

Duration of efficacy increases with the repetition of botulinum toxin A injections in primary palmar hyperhidrosis: a study of 28 patients.

PubMed

Lecouflet, Marie; Leux, Christophe; Fenot, Marion; Célerier, Philippe; Maillard, Hervé

2014-06-01

Intradermal injections of botulinum toxin are effective but transitory in primary palmar hyperhidrosis. These injections are repeated when the symptoms recur. We do not know how the duration of efficacy changes when injections are repeated. In this retrospective study, we aimed to investigate the change in the duration of efficacy of botulinum toxin A (Dysport, Ipsen, Boulogne-Billancourt, France) with the repetition of injections in patients with primary palmar hyperhidrosis. From May 2001 to April 2012, 28 patients were treated with a dose of 250 U of botulinum toxin A per palm. We compared the duration of efficacy of the first and last toxin injections. The median duration of efficacy was 7 months for the first injection and 9.5 months for the last, the difference being statistically significant (P = .0002). Study limitations include a relatively small number of patients treated at a single center and evaluated retrospectively. To our knowledge, this study is the first to report a significant increase in the duration of efficacy of botulinum toxin A injections with the repetition of injections in patients with primary palmar hyperhidrosis. The reasons for this effect may be linked to the mechanism of action of botulinum toxin, and may improve our understanding of its pharmacologic effects. Copyright © 2014 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

Feasibility of extended use of an electromagnetic lithotripter beyond the manufacturer's recommended maintenance schedule.

PubMed

Chen, Tony Y H; Ponsot, Yves; Brouillette, Martin; Tétrault, Jean-Píerre; Tu, Le Mai

2007-06-01

The study evaluates the effect of chronic usage, beyond the recommended maintenance schedule, on the efficacy of electromagnetic lithotripter. To our knowledge, there is no publication investigating the effect of chronic usage on the electromagnetic lithotripter, despite the maintenance schedule established by the manufacturers. Our goal is to verify if the acoustic parameters of the shock wave changed with usage, and if this change could be associated with change in clinical efficacy. This study lasted 18 months. Every 6 months the lithotripter's efficacy was evaluated in two ways: objectively and clinically. Objective efficacy was measured using a piezoelectric hydrophone and artificial stones to capture the acoustic parameters and the crater of fragmentation, respectively. Clinical efficacy data was collected by studying the rate of successful extracorporeal shock wave lithotripsy treatment in patients with urolithiasis. The changes in clinical efficacy, acoustic parameters, and craters of fragmentation were compared and analyzed with appropriate statistical methods. Five hundred twenty five patients participated in the study. The clinical efficacy remained stable throughout the three observation periods (55.7%, 66.2% and 55.5%; p = 0.11). The focal head of the lithotripter was used three times the recommended schedule. There was no obvious change in the acoustic parameters of the shock waves, and the focal zone remained stable. The clinical efficacy of the electromagnetic lithotripter appears to be stable despite usage beyond the recommended maintenance schedule. More studies are needed to validate the safety of this practice.

Prospective Primary Teachers' Self-Efficacy and Emotions in Science Teaching

ERIC Educational Resources Information Center

Brigido, Maria; Borrachero, Ana Belen; Bermejo, Maria Luisa; Mellado, Vicente

2013-01-01

The self-efficacy of prospective primary teachers was studied, considering in particular the relationship of that construct with the emotions they expect to experience as future science teachers, differentiating between when they will be teaching the content of the "nature sciences" (biology and geology) and that of the "hard…

Primary Grade Teachers' Knowledge and Perceptions of Head Lice.

ERIC Educational Resources Information Center

Kirchofer, Gregg M.; Price, James H.; Telljohann, Susan K.

2001-01-01

Surveyed primary school teachers regarding knowledge of head lice, self-efficacy in handling head lice, and preferred information sources. Teachers needed more knowledge about head lice. About half had high efficacy expectations regarding their ability to control the spread of lice. Most reported receiving information from school nurses. Knowledge…

[Therapeutic drug monitoring of levetiracetam].

PubMed

Dailly, Eric; Bouquié, Régis; Bentué-Ferrer, Danièle

2010-01-01

Levetiracetam is an anticonvulsant drug used to treat partial seizures, myoclonic seizures of juvenile myoclonic epilepsy and primary generalized tonic-clonic seizures. A review of the literature with an evidence-based medicine method highlighted parameters (age, renal failure, pregnancy, combination with other anticonvulsant drugs) which affect levetiracetam pharmacokinetics but no significant relationship between plasma concentration of levetiracetam and efficacy or toxicity. Concentrations usually observed in therapeutics is from 6 to 18 mg/L. However, the determination of an individual therapeutic concentration, associated with an effective and well tolerated therapy, could be recommended particularly before pregnancy. Consequently, therapeutic drug monitoring of levetiracetam which is not currently recommended could be possibly useful in specific clinical situations.

Safety and Efficacy of a Pharmacoinvasive Strategy in ST-Segment Elevation Myocardial Infarction: A Patient Population Study Comparing a Pharmacoinvasive Strategy With a Primary Percutaneous Coronary Intervention Strategy Within a Regional System.

PubMed

Rashid, Mohammed K; Guron, Nita; Bernick, Jordan; Wells, George A; Blondeau, Melissa; Chong, Aun-Yeong; Dick, Alexander; Froeschl, Michael P V; Glover, Chris A; Hibbert, Benjamin; Labinaz, Marino; Marquis, Jean-François; Osborne, Christina; So, Derek Y; Le May, Michel R

2016-10-10

This study investigated the safety and efficacy of a pharmacoinvasive strategy compared with a primary percutaneous coronary intervention (PCI) strategy for ST-segment elevation myocardial infarction (STEMI) in the context of a real-world system. Primary PCI continues to be the optimal reperfusion therapy; however, in areas where PCI centers are not readily available, a pharmacoinvasive strategy has been proposed. The University of Ottawa Heart Institute regional STEMI system provides a primary PCI strategy for patients presenting within a 90-km radius from the PCI center, and a pharmacoinvasive strategy for patients outside this limit. We included all confirmed STEMI patients between April 2009 and May 2011. The primary efficacy outcome was a composite of mortality, reinfarction, or stroke and the primary safety outcome was major bleeding. We identified 236 and 980 consecutive patients enrolled in pharmacoinvasive and primary PCI strategies, respectively. The median door-to-needle time was 31 min in the pharmacoinvasive group and the median door-to-balloon time was 95 min in the primary PCI group. In a multivariable model, there was no significant difference in the primary efficacy outcome (odds ratio: 1.54; p = 0.21); however, the propensity for more bleeding with a pharmacoinvasive strategy approached statistical significance (odds ratio: 2.02; p = 0.08). Within the context of a STEMI system, a pharmacoinvasive strategy was associated with similar rates of the composite of mortality, reinfarction, or stroke as compared with a primary PCI strategy; however, there was a propensity for more bleeding with a pharmacoinvasive strategy. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

A review of dopamine agonist therapy in type 2 diabetes and effects on cardio-metabolic parameters.

PubMed

Lamos, E M; Levitt, D L; Munir, K M

2016-02-01

Dopamine action appears to play a role in changes that are seen in obesity, metabolic syndrome and type 2 diabetes mellitus. Bromocriptine-QR (Quick Release), a dopamine agonist, is approved for use in treatment of type 2 diabetes. It has demonstrated modest improvement in glycemic parameters, cholesterol and weight in certain cohorts. Limited data using cabergoline, a long-acting dopamine agonist, also demonstrate glycemic efficacy. Additionally, bromocriptine-QR appears to have a favorable cardiovascular risk reduction. The direct mechanism by which bromocriptine-QR, or central dopamine agonism, achieves modest glycemic control and favorable cardio-metabolic profile is unclear. This relationship appears to be more complex than the historical explanation of "resetting" the circadian clock and may further be elucidated using data in individuals with hyperprolactinemia and prolactinoma. Copyright © 2015 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.

Bupropion for the treatment of apathy in Huntington’s disease: A multicenter, randomised, double-blind, placebo-controlled, prospective crossover trial

PubMed Central

Gelderblom, Harald; Wüstenberg, Torsten; McLean, Tim; Mütze, Lisanne; Fischer, Wilhelm; Saft, Carsten; Hoffmann, Rainer; Süssmuth, Sigurd; Schlattmann, Peter; van Duijn, Erik; Landwehrmeyer, Bernhard; Priller, Josef

2017-01-01

Objective To evaluate the efficacy and safety of bupropion in the treatment of apathy in Huntington’s disease (HD). Methods In this phase 2b multicentre, double-blind, placebo-controlled crossover trial, individuals with HD and clinical signs of apathy according to the Structured Clinical Interview for Apathy—Dementia (SCIA-D), but not depression (n = 40) were randomized to receive either bupropion 150/300mg or placebo daily for 10 weeks. The primary outcome parameter was a significant change of the Apathy Evaluation Scale (AES) score after ten weeks of treatment as judged by an informant (AES-I) living in close proximity with the study participant. The secondary outcome parameters included changes of 1. AES scores determined by the patient (AES-S) or the clinical investigator (AES-C), 2. psychiatric symptoms (NPI, HADS-SIS, UHDRS-Behavior), 3. cognitive performance (SDMT, Stroop, VFT, MMSE), 4. motor symptoms (UHDRS-Motor), 5. activities of daily function (TFC, UHDRS-Function), and 6. caregiver distress (NPI-D). In addition, we investigated the effect of bupropion on brain structure as well as brain responses and functional connectivity during reward processing in a gambling task using magnetic resonance imaging (MRI). Results At baseline, there were no significant treatment group differences in the clinical primary and secondary outcome parameters. At endpoint, there was no statistically significant difference between treatment groups for all clinical primary and secondary outcome variables. Study participation, irrespective of the intervention, lessened symptoms of apathy according to the informant and the clinical investigator. Conclusion Bupropion does not alleviate apathy in HD. However, study participation/placebo effects were observed, which document the need for carefully controlled trials when investigating therapeutic interventions for the neuropsychiatric symptoms of HD. Trial registration ClinicalTrials.gov 01914965 PMID:28323838

Short- and long-term effects of mud-bath treatment on hand osteoarthritis: a randomized clinical trial

NASA Astrophysics Data System (ADS)

Fioravanti, Antonella; Tenti, Sara; Giannitti, Chiara; Fortunati, Nicola Angelo; Galeazzi, Mauro

2014-01-01

The aim of this study was to evaluate both the short-term and the long-term effectiveness of spa therapy in patients with primary hand osteoarthritis (OA). This was a prospective randomized, single blind controlled trial. Sixty outpatients with primary bilateral hand OA were included in the study and randomized to one of two groups. One group ( n = 30) was treated with 12 daily local mud packs and generalized thermal baths with a sulfate-calcium-magnesium-fluorides mineral water added to usual treatment. The control group ( n = 30) continued regular outpatient care routine (exercise, NSAIDs and/or analgesics). Each patient was examined at baseline, after 2 weeks, and after 3, 6, 9 and 12 months. Primary outcome measures were global spontaneous hand pain on a visual analogue scale (VAS) and the functional index for hand osteoarthritis (FIHOA) score; secondary outcomes were health assessment questionnaire (HAQ), duration of morning stiffness, medical outcomes study 36-item short form (SF-36) and symptomatic drugs consumption. Our results demonstrated that the efficacy of spa therapy was significant in all the assessed parameters, both at the end of therapy and after 3 months; the values of FIHOA, HAQ and drugs consumption continued to be significantly better after 6 months in comparison with baseline. There were no significant modifications of the parameters throughout the follow-up in the control group. Differences between the two groups were significant for all parameters at the 15th day and at 3 months follow-up; regarding FIHOA, HAQ, and symptomatic drugs consumption, the difference between the two groups persisted and was significant at 6month follow-up. Tolerability of spa therapy seemed to be good. In conclusion, our results confirm that the beneficial effects of spa therapy in patients with hand OA last over time.

Management of pediatric mandibular fractures using bioresorbable plating system - Efficacy, stability, and clinical outcomes: Our experiences and literature review.

PubMed

Singh, Mahinder; Singh, R K; Passi, Deepak; Aggarwal, Mohit; Kaur, Guneet

2016-01-01

The purpose of this study was to determine the efficacy and stability of the biodegradable fixation system for treatment of mandible fractures in pediatric patients by measuring the bite force. Sixty pediatric patients with mandibular fractures (36 males, 24 females) were included in this study. The 2.5-mm resorbable plates were adapted along Champy's line of ideal osteosynthesis and secured with four 2.5 mm diameter monocortical resorbable screws, 8 mm in length. All patients were followed for 10 months. Clinical parameters, such as soft tissue infection, nonunion, malunion, implant exposure, malocclusion, nerve injury, and bite force for stability, were prospectively assessed. Adequate fixation and primary bone healing was achieved in 100% of the cases. Six minor complications (10%) were observed: 2 soft tissue infections (3%), 1 plate dehiscence (2%), 1 malocclusion (2%), and 2 paresthesia (3%). 2.5-mm resorbable plating system along Champy's line of ideal osteosynthesis is a good treatment modality for mandible fractures in pediatric patients.

Effect of Ranirestat on Sensory and Motor Nerve Function in Japanese Patients with Diabetic Polyneuropathy: A Randomized Double-Blind Placebo-Controlled Study

PubMed Central

Satoh, Jo; Kohara, Nobuo; Sekiguchi, Kenji; Yamaguchi, Yasuyuki

2016-01-01

We conducted a 26-week oral-administration study of ranirestat (an aldose reductase inhibitor) at a once-daily dose of 20 mg to evaluate its efficacy and safety in Japanese patients with diabetic polyneuropathy (DPN). The primary endpoint was summed change in sensory nerve conduction velocity (NCV) for the bilateral sural and proximal median sensory nerves. The sensory NCV was significantly (P = 0.006) improved by ranirestat. On clinical symptoms evaluated with the use of modified Toronto Clinical Neuropathy Score (mTCNS), obvious efficacy was not found in total score. However, improvement in the sensory test domain of the mTCNS was significant (P = 0.037) in a subgroup of patients diagnosed with neuropathy according to the TCNS severity classification. No clinically significant effects on safety parameters including hepatic and renal functions were observed. Our results indicate that ranirestat is effective on DPN (Japic CTI-121994). PMID:26881251

Treatment of rheumatoid arthritis with biologic DMARDS (Rituximab and Etanercept).

PubMed

Gashi, Afrim A; Rexhepi, Sylejman; Berisha, Idriz; Kryeziu, Avni; Ismaili, Jehona; Krasniqi, Gezim

2014-01-01

To determine efficacy and safety of treatment with Rituximab and Etanercept plus Methotrexate in patients with active Rheumatoid Arthritis (RA), who had an inadequate response to nonbiologic DMARDS therapies and to explore the pharmacogenetics and pharmacodynamics of Rituximab and Etanercept in our populations. Study was done at Rheumatology Clinic of University Clinical Centre in Prishtina during 2009-2011 years. We evaluated primary efficacy and safety at 24 weeks in patients enrolled in the study of long-term efficacy of Rituximab and Etanercept. Patients with active Rheumatoid Arthritis and an inadequate response to 1 or more non biologic DMARDS were randomized to receive intravenous Rituximab (1 course consisting of 2 infusions of 1.000 mg each -one group, and Etanercept 25 mg twice weekly -second group, but both groups with background MTX. The primary efficacy end point was a response on the ACR 20%, improvement criteria at 24 weeks, Secondary end points were responses on the ACR 50 and ACR 70, improvement criteria, the DAS 28, and EULAR response criteria at 24 weeks. During our investigations we treated 20 patients, 15 females and 5 males, in the treated group with RTX and 13 patients 8 females and 5 males in the treated group with ETN. Patients of group 1 and group 2 were of ages 37-69 years old and 19-69 years old (average 47-44) Most of the patients belong in 2nd and 3rd functional stage according to Steinbrocker. All ACR response parameters were significantly improved in RTX treated patients who also had clinically meaningful improvement in fatigue, disability and quality of life. Patients showed a trend less progression in radiographic end points. Most adverse events occurred with the first RTX infusion and were mild to moderate severity. At 24 weeks, a single course of RTX and ETN provided significant and clinically meaningful improvements in disease activity in patients with active, longstanding RA who had an inadequate response to 1 or more nonbiologic DMARDS.

Effects of tangible social support and depression on diabetes self-efficacy.

PubMed

Coffman, Maren J

2008-04-01

Although social support has been found to promote health and decrease depression in individuals with diabetes, little research has examined the kinds and sources of support. This descriptive correlational study examined the effects of diabetes-related tangible social support and depression on diabetes self-efficacy in Hispanic older adults. Participants were predominantly Puerto Rican, and many were depressed. Primary support needs included transportation and communication; family was the primary source of support. Variables associated with diabetes self-efficacy included tangible support and education. Understanding the relationship between diabetes tangible support, depression, and diabetes self-efficacy will help nurses adapt their care.

Humility and Forgiveness as Predictors of Teacher Self-Efficacy

ERIC Educational Resources Information Center

Sezgin, Ferudun; Erdogan, Onur

2018-01-01

This study explores the predictive influence of teachers' humility and forgiveness on their self-efficacy perceptions. The population of this research consists of teachers who work at public primary and secondary schools located in the central districts of Ankara, Turkey. The sample of the study is composed of 303 primary and secondary school…

Generalist Teachers' Self-Efficacy in Primary School Music Teaching

ERIC Educational Resources Information Center

de Vries, Peter

2013-01-01

This qualitative study focuses on the music teaching experiences of five Australian generalist primary school teachers in their third year of teaching. The aim was to identify these teachers' current practices in teaching music, in particular their self-efficacy in relation to teaching music. A narrative inquiry methodology was employed, drawing…

Improving Universal Suicide Prevention Screening in Primary Care by Reducing False Negatives

DTIC Science & Technology

2017-09-01

develop a shortened version of the Suicide Cognitions Scale (SCS) and to evaluate its efficacy as a universal suicide prevention screen for use in... Cognitions Scale (SCS) and to evaluate its efficacy as a universal suicide prevention screen for use in military primary care clinics. We propose to

Primary Pre-Service Teachers' Perceptions of Course Related Factors That Enhance Instructional Self-Efficacy

ERIC Educational Resources Information Center

Christian, Beverly J.

2017-01-01

Pre-service teachers' instructional self-efficacy, that is, their belief in their own ability to foster learning with instructional tactics, is one predictor of classroom effectiveness. This qualitative investigation used focus groups to gather data from fifty-one preservice teachers enrolled in one Bachelor of Education (Primary) degree in…

Teachers’ work ability: a study of relationships between collective efficacy and self-efficacy beliefs

PubMed Central

Guidetti, Gloria; Viotti, Sara; Bruno, Andreina; Converso, Daniela

2018-01-01

Introduction Work ability constitutes one of the most studied well-being indicators related to work. Past research highlighted the relationship with work-related resources and demands, and personal resources. However, no studies highlight the role of collective and self-efficacy beliefs in sustaining work ability. Purpose The purpose of this study was to examine whether and by which mechanism work ability is linked with individual and collective efficacies in a sample of primary and middle school teachers. Materials and methods Using a dataset consisting of 415 primary and middle school Italian teachers, the analysis tested for the mediating role of self-efficacy between collective efficacy and work ability. Results Mediational analysis highlights that teachers’ self-efficacy totally mediates the relationship between collective efficacy and perceived work ability. Conclusion Results of this study enhance the theoretical knowledge and empirical evidence regarding the link between teachers’ collective efficacy and self-efficacy, giving further emphasis to the concept of collective efficacy in school contexts. Moreover, the results contribute to the study of well-being in the teaching profession, highlighting a process that sustains and promotes levels of work ability through both collective and personal resources. PMID:29861646

Pre-Service English Language Teachers' Perceptions of Computer Self-Efficacy and General Self-Efficacy

ERIC Educational Resources Information Center

Topkaya, Ece Zehir

2010-01-01

The primary aim of this study is to investigate pre-service English language teachers' perceptions of computer self-efficacy in relation to different variables. Secondarily, the study also explores the relationship between pre-service English language teachers' perceptions of computer self-efficacy and their perceptions of general self-efficacy.…

Ciprofibrate therapy in patients with hypertriglyceridemia and low high density lipoprotein (HDL)-cholesterol: greater reduction of non-HDL cholesterol in subjects with excess body weight (The CIPROAMLAT study)

PubMed Central

Aguilar-Salinas, Carlos A; Assis-Luores-Vale, Andréia; Stockins, Benjamín; Rengifo, Hector Mario; Filho, José Dondici; Neto, Abrahão Afiune; Rabelo, Lísia Marcílio; Torres, Kerginaldo Paulo; Oliveira, José Egídio Paulo de; Machado, Carlos Alberto; Reyes, Eliana; Saavedra, Victor; Florenzano, Fernando; Hernández, Ma Victoria; Jiménez, Sergio Hernandez; Ramírez, Erika; Vazquez, Cuauhtémoc; Salinas, Saul; Hernández, Ismael; Medel, Octavio; Moreno, Ricardo; Lugo, Paula; Alvarado, Ricardo; Mehta, Roopa; Gutierrez, Victor; Gómez Pérez, Francisco J

2004-01-01

Background Hypertriglyceridemia in combination with low HDL cholesterol levels is a risk factor for cardiovascular disease. Our objective was to evaluate the efficacy of ciprofibrate for the treatment of this form of dyslipidemia and to identify factors associated with better treatment response. Methods Multicenter, international, open-label study. Four hundred and thirty seven patients were included. The plasma lipid levels at inclusion were fasting triglyceride concentrations between 1.6–3.9 mM/l and HDL cholesterol ≤ 1.05 mM/l for women and ≤ 0.9 mM/l for men. The LDL cholesterol was below 4.2 mM/l. All patients received ciprofibrate 100 mg/d. Efficacy and safety parameters were assessed at baseline and at the end of the treatment. The primary efficacy parameter of the study was percentage change in triglycerides from baseline. Results After 4 months, plasma triglyceride concentrations were decreased by 44% (p < 0.001). HDL cholesterol concentrations were increased by 10% (p < 0.001). Non-HDL cholesterol was decreased by 19%. A greater HDL cholesterol response was observed in lean patients (body mass index < 25 kg/m2) compared to the rest of the population (8.2 vs 19.7%, p < 0.001). In contrast, cases with excess body weight had a larger decrease in non-HDL cholesterol levels (-20.8 vs -10.8%, p < 0.001). There were no significant complications resulting from treatment with ciprofibrate. Conclusions Ciprofibrate is efficacious for the correction of hypertriglyceridemia / low HDL cholesterol. A greater decrease in non-HDL cholesterol was found among cases with excess body weight. The mechanism of action of ciprofibrate may be influenced by the pathophysiology of the disorder being treated. PMID:15272932

Simplified Models of Vector Control Impact upon Malaria Transmission by Zoophagic Mosquitoes

PubMed Central

Kiware, Samson S.; Chitnis, Nakul; Moore, Sarah J.; Devine, Gregor J.; Majambere, Silas; Merrill, Stephen; Killeen, Gerry F.

2012-01-01

Background High coverage of personal protection measures that kill mosquitoes dramatically reduce malaria transmission where vector populations depend upon human blood. However, most primary malaria vectors outside of sub-Saharan Africa can be classified as “very zoophagic,” meaning they feed occasionally (<10% of blood meals) upon humans, so personal protection interventions have negligible impact upon their survival. Methods and Findings We extended a published malaria transmission model to examine the relationship between transmission, control, and the baseline proportion of bloodmeals obtained from humans (human blood index). The lower limit of the human blood index enables derivation of simplified models for zoophagic vectors that (1) Rely on only three field-measurable parameters. (2) Predict immediate and delayed (with and without assuming reduced human infectivity, respectively) impacts of personal protection measures upon transmission. (3) Illustrate how appreciable indirect communal-level protection for non-users can be accrued through direct personal protection of users. (4) Suggest the coverage and efficacy thresholds required to attain epidemiological impact. The findings suggest that immediate, indirect, community-wide protection of users and non-users alike may linearly relate to the efficacy of a user’s direct personal protection, regardless of whether that is achieved by killing or repelling mosquitoes. High protective coverage and efficacy (≥80%) are important to achieve epidemiologically meaningful impact. Non-users are indirectly protected because the two most common species of human malaria are strict anthroponoses. Therefore, the small proportion of mosquitoes that are killed or diverted while attacking humans can represent a large proportion of those actually transmitting malaria. Conclusions Simplified models of malaria transmission by very zoophagic vectors may be used by control practitioners to predict intervention impact interventions using three field-measurable parameters; the proportion of human exposure to mosquitoes occurring when an intervention can be practically used, its protective efficacy when used, and the proportion of people using it. PMID:22701527

Structure-Activity Relationship of the Antimalarial Ozonide Artefenomel (OZ439).

PubMed

Dong, Yuxiang; Wang, Xiaofang; Kamaraj, Sriraghavan; Bulbule, Vivek J; Chiu, Francis C K; Chollet, Jacques; Dhanasekaran, Manickam; Hein, Christopher D; Papastogiannidis, Petros; Morizzi, Julia; Shackleford, David M; Barker, Helena; Ryan, Eileen; Scheurer, Christian; Tang, Yuanqing; Zhao, Qingjie; Zhou, Lin; White, Karen L; Urwyler, Heinrich; Charman, William N; Matile, Hugues; Wittlin, Sergio; Charman, Susan A; Vennerstrom, Jonathan L

2017-04-13

Building on insights gained from the discovery of the antimalarial ozonide arterolane (OZ277), we now describe the structure-activity relationship (SAR) of the antimalarial ozonide artefenomel (OZ439). Primary and secondary amino ozonides had higher metabolic stabilities than tertiary amino ozonides, consistent with their higher pK a and lower log D 7.4 values. For primary amino ozonides, addition of polar functional groups decreased in vivo antimalarial efficacy. For secondary amino ozonides, additional functional groups had variable effects on metabolic stability and efficacy, but the most effective members of this series also had the highest log D 7.4 values. For tertiary amino ozonides, addition of polar functional groups with H-bond donors increased metabolic stability but decreased in vivo antimalarial efficacy. Primary and tertiary amino ozonides with cycloalkyl and heterocycle substructures were superior to their acyclic counterparts. The high curative efficacy of these ozonides was most often associated with high and prolonged plasma exposure, but exposure on its own did not explain the presence or absence of either curative efficacy or in vivo toxicity.

Critical reappraisal of embryo quality as a predictive parameter for pregnancy outcome: a pilot study.

PubMed

Campo, R; Binda, M M; Van Kerkhoven, G; Frederickx, V; Serneels, A; Roziers, P; Lopes, A S; Gordts, S; Puttemans, P; Gordts, S

2010-01-01

Pilot study to analyse the efficacy and embryo morphology using a new human embryo culture medium (GM501) versus the conventional used medium (ISM1). Over a four-month period, all patients at the Leuven Institute of Fertility and Embryology (LIFE) were -randomly allocated to have their embryos cultured in either the standard sequential culture medium ISM1 (control) or in a new universal medium (GM501) (study group). Primary outcome parameters were clinical pregnancy and live birth rate. The secondary outcome parameter was the correlation of embryo fragmentation rate with pregnancy outcome. We did not observe any differences between the ISM1 control group and GM501 study group with regard to fertilization, pregnancy, implantation rates, ongoing pregnancy, and babies born. The number of embryos with a minimal fragmentation rate (less than 30%) was significantly higher in the GM501 study group. Although a significant higher embryo fragmentation rate was seen in In vitro culture of embryos in GM501, pregnancy outcome results were comparable to those of embryos cultured in ISM1. According to our results the value of embryo morphological criteria as a parameter for pregnancy outcome should be examined and discussed again.

Parental self-efficacy and its measurement - an evaluation of a parental self-efficacy measurement scale.

PubMed

Purssell, Edward; While, Alison

2013-05-01

To field test a parental self-efficacy scale regarding its acceptability and feasibility and to describe parental self-efficacy in a convenience sample of parents with children aged 6 years old or less. Self-care within families is increasingly emphasised in health policy as a means of maximising healthcare resources. This study reports the field testing of a scale designed to measure parental self-efficacy. Cross-sectional survey of parents of children aged 6 years old or less. Subjects were recruited through a parenting internet website (n = 84) and local parenting and community organisations (n = 68) and asked to complete a questionnaire containing the scale. Data collection took place between January and August 2011. The scale, previously validated with an expert panel of professionals, gathered information about parental self-efficacy when administered either directly or through an on-line data collection portal, although there were more missing data when administered via the Internet. Although convenience and self-selecting samples precluded parameter estimation, areas of concern highlighted were difficulties differentiating children with serious illnesses and the use of the Personal Child Health Record. Use of the Internet was widespread, as was use of community pharmacists and nursery staff. Although the primary purpose was not to collect specific data, the data indicated the continuing concern of parents regarding serious illness and where additional investment may be required to meet parental needs and expectations. The previously validated scale can be used to collect information about parental self-efficacy either through a paper questionnaire or the Internet. Although there was slightly more missing data from the Internet version, the ease of its administration makes this an attractive option. Parents generally reported high levels of self-efficacy and satisfaction with services; however, the scale was able to identify areas where further investment might be useful. © 2012 Blackwell Publishing Ltd.

The Relationship between Primary School Teacher Candidates' Tendency for Lifelong Learning and Their Perceptions of Computer Self-Efficacy

ERIC Educational Resources Information Center

Isik, Ayse Derya

2015-01-01

This study determines the relationship between primary school teacher candidates' lifelong learning tendency and their perceptions of computer self-efficacy. The research was carried out with 92 undergraduate teachers studying at Bartin University of Teacher Education Faculty, in 2014-2015 academic year. In this study, personal information…

Academic Optimism, Hope and Zest for Work as Predictors of Teacher Self-Efficacy and Perceived Success

ERIC Educational Resources Information Center

Sezgin, Ferudun; Erdogan, Onur

2015-01-01

This study explores the predictive influence of primary school teachers' academic optimism, hope and zest for work on perceptions of their self-efficacy and success. A total of 600 teachers were selected through stratified sampling from 27 primary schools in central districts of Ankara, Turkey, to form the research sample. Intervariable…

Mathematics Teaching Anxiety and Self-Efficacy Beliefs toward Mathematics Teaching: A Path Analysis

ERIC Educational Resources Information Center

Peker, Murat

2016-01-01

The purpose of this study was to investigate the relationship between pre-service primary school teachers' mathematics teaching anxiety and their self-efficacy beliefs toward mathematics teaching through path analysis. There were a total of 250 pre-service primary school teachers involved in this study. Of the total, 202 were female and 48 were…

Investigating the Interrelationships among Conceptions of, Approaches to, and Self-Efficacy in Learning Science

ERIC Educational Resources Information Center

Zheng, Lanqin; Dong, Yan; Huang, Ronghuai; Chang, Chun-Yen; Bhagat, Kaushal Kumar

2018-01-01

The purpose of this study was to examine the relations between primary school students' conceptions of, approaches to, and self-efficacy in learning science in Mainland China. A total of 1049 primary school students from Mainland China participated in this study. Three instruments were adapted to measure students' conceptions of learning science,…

Association of the clinical efficacy of vancomycin with the novel pharmacokinetic parameter area under the trough level (AUTL) in elderly patients with hospital-acquired pneumonia.

PubMed

Fukumori, S; Tsuji, Y; Mizoguchi, A; Kasai, H; Ishibashi, T; Iwamura, N; To, H

2016-08-01

The pharmacokinetic-pharmacodynamic parameter that best predicts the efficacy of vancomycin is the ratio of the area under the concentration versus time curve (AUC) to the minimum inhibitory concentration (MIC). A 24-h AUC (AUC24 )/MIC ratio ≥ 400 was recommended in an American consensus review, but vancomycin treatment occasionally fails despite maintenance of AUC24 /MIC ≥ 400. We evaluated the association between clinical efficacy of vancomycin and two novel pharmacokinetic parameters, the 'area under the trough level' (AUTL) and the 'area above the trough level' (AATL), in hospitalized elderly patients with methicillin-resistant Staphylococcus aureus (MRSA) pneumonia. The subjects were hospitalized elderly patients who were administered vancomycin for treatment of MRSA pneumonia between 2006 and 2012 at Sasebo Chuo Hospital (Nagasaki, Japan). Pharmacokinetic parameters of vancomycin were estimated for each patient by Bayesian analysis using population pharmacokinetic parameters for Japanese patients. Based on the patient-specific parameters thus obtained, AUC24 values were calculated as the vancomycin dosage divided by vancomycin clearance. AUTL was calculated as the trough serum concentration multiplied by 24 h, whereas AATL was calculated by subtracting AUTL from AUC24 . Logistic regression analysis demonstrated that efficacy of vancomycin was more strongly associated with AUTL than AUC24 . The optimal cut-off value of AUTL was 331 μg∙h/mL, which means that the optimal cut-off value of the trough serum concentration was 13·8 μg/mL. Efficacy of vancomycin was associated with AUTL, a novel pharmacokinetic parameter. Determining the target AUTL or trough concentration may enhance the efficacy of vancomycin therapy in elderly patients with MRSA pneumonia. Given that nephrotoxicity may increase with a Ctrough in excess of 15 μg/mL, this level should ideally not be exceeded. © 2016 John Wiley & Sons Ltd.

The efficacy of Cognitive-Behavioural Therapy (CBT) as related to sleep quality and hyperarousal level in the treatment of primary insomnia.

PubMed

Gałuszko-Węgielnik, Maria; Jakuszkowiak-Wojten, Katarzyna; Wiglusz, Mariusz Stanisław; Cubała, Wiesław Jerzy; Landowski, Jerzy

2012-09-01

Primary insomnia (PI) is a common sleep disorder affecting diurnal functioning. It may contribute to the development of several comorbidities such as major depression or arterial hypertension. It affects about 7% of the adult population. Pharmacotherapy remains the most common treatment for insomnia. However, many studies suggest CBT may be a supreme therapeutic approach resulting in a better long-term outcome. The aim of the study was to determine the efficacy of a CBT-protocol in the treatment of PI by means of sleep onset latency and the number of awakenings during night parameters along with sleep quality and the level of psychophysiological hyperarousal. The secondary outcomes were focused on CBT efficacy as determined by the predisposition to insomnia as related to higher vulnerability to stress (measured with FIRST) MATERIAL AND METHODS: Twenty-six individuals from a tertiary reference sleep disorders outpatients' clinic (22 women; mean age 41.4; 4 men; mean age 42.5) with primary insomnia (DSM-IV-TR) were included in the study. The exclusion covered other primary sleep disorders, secondary insomnia (psychiatric illness, unstable somatic illness, shift work), substance abuse/dependence, high results in HADS-M scale (score above 11). The participants were scored with HADS-M, Ford Insomnia Response to Stress Test (FIRST) at the beginning of the study. The Athens Insomnia Scale (AIS), Hyperarousal Scale, Leeds Sleep Questionnaire (LSEQ) were applied at the beginning, at the end and three months after the end of the study. The participants were also examined by 7 days actigraphic records before and after treatment. During the course of the treatment patients completed a Sleep Diary (SD). The CBT program employed was based on the Perlis protocol. Standard individual sessions of 50 minutes were provided on a weekly basis for 8-10 weeks by a board certified CBT therapist. After 3 months a follow-up session was scheduled. The significant improvement as related to the CBT treatment was present in the measures of sleep onset latency (67.2 vs. 23.4 min.; p<0.000), numbers of awakenings during night (2 vs. 0.4; p<0.000) and sleep efficiency (77.3 vs. 91%; p<0.000) - data from SD, quality of falling asleep (3.2 vs. 6; p<0.000), quality of sleep (3.3 vs. 5.8; p<0.000) and quality of morning awakening (3.2 vs. 6; p<0.000) - data from LSEQ. The improvement reached the significance level in the measure of psychophysiological arousal (52.3 vs. 42.4; p<0.000) and AIS (15.7vs. 6.8; p<0.000). No significant differences were identified between actigraphic records (light/dark ratio) before and after CBT. FIRST scores allocating patients to high and low stress vulnerability groups were non-contributory to the observed treatment efficacy. CBT is an effective treatment in primary insomnia. No relationship between CBT efficacy and predisposition to insomnia as determined by higher vulnerability to stress was identified.

Replacement of aprotinin by ε-aminocaproic acid in infants undergoing cardiac surgery: consequences for blood loss and outcome.

PubMed

Martin, K; Gertler, R; MacGuill, M; Mayr, N P; Hapfelmeier, A; Hörer, J; Vogt, M; Tassani, P; Wiesner, G

2013-04-01

Once aprotinin was no longer available for clinical use, ε-aminocaproic acid (EACA) and tranexamic acid became the only two options for antifibrinolytic therapy. We compared aprotinin and EACA with respect to their blood-sparing efficacy and other major clinical outcome criteria in infants undergoing cardiac surgery. We retrospectively analysed data from a large consecutive cohort of infants (n=227) aged 31-365 days undergoing primary cardiac surgery requiring cardiopulmonary bypass encompassing the transition from aprotinin to EACA (aprotinin n=88, EACA n=139); all other aspects including the medical team and departmental protocols remained unchanged. The primary outcome was postoperative blood loss measured as chest tube output (CTO). Secondary outcome parameters were transfusion requirements, reoperation due to bleeding, renal, vascular, and neurological complications, and in-hospital mortality. CTO was significantly higher in the EACA patients {aprotinin 18 (13-27) ml kg(-1) 24 h(-1), EACA 23 (15-37) ml kg(-1) 24 h(-1) [mean (inter-quartile range)], P=0.001}, but transfusion requirements and donor exposures were not significantly different. A sensitivity analysis strengthened our finding that the increased blood loss in the EACA group was attributable to lower efficacy of EACA. There were no significant differences in the other clinical outcome measures. CTO was lower in aprotinin-treated patients. Nonetheless, EACA remains a suitable substitute without measurable differences in other clinical outcome criteria.

Serial protocol biopsies to quantify the progression of chronic transplant nephropathy in stable renal allografts.

PubMed

Moreso, F; Lopez, M; Vallejos, A; Giordani, C; Riera, L; Fulladosa, X; Hueso, M; Alsina, J; Grinyó, J M; Serón, D

2001-05-01

To evaluate the utility of intimal thickness and interstitial width as a primary efficacy variable in the design of clinical trials aimed to modify the natural history of chronic allograft nephropathy. A donor and a 4-month protocol biopsy were evaluated in 40 stable grafts according to the Banff schema. In 27 patients, a second protocol biopsy was done at 1 yr. Arterial intimal volume fraction (Vvintima/artery) and cortical interstitial volume fraction (Vvinterstitium/cortex) were estimated with a point counting technique. Chronic Banff scores increased during follow-up, while acute scores reached its peak at 4 months. Vvintima/artery and Vvinterstitium/cortex significantly increased at 4 months, but not at 1 yr. Vvintima/artery at 4 months correlated with donor Vvintima/artery (r = 0.57, p < 0.001), histocompatibility (r = 0.38, p = 0.01) and serum cholesterol (r = 0.31, p = 0.047). Vvinterstitium/cortex at 4 months correlated with recipient body surface area (r = 0.44, p = 0.004) and delayed graft function (p = 0.016). Power calculations showed that Vvintima/artery and Vvinterstitium/cortex allow an important reduction in minimum sample size of a hypothetical trial aimed to prevent chronic allograft nephropathy. Intimal thickening and interstitial widening progresses rapidly during the first 4 months after transplantation and slowly thereafter. These parameters can be considered as a primary efficacy variable in trials aimed to prevent chronic allograft nephropathy.

PLGA nanoparticles loaded with the antileishmanial saponin β-aescin: factor influence study and in vitro efficacy evaluation.

PubMed

Van de Ven, H; Vermeersch, M; Matheeussen, A; Vandervoort, J; Weyenberg, W; Apers, S; Cos, P; Maes, L; Ludwig, A

2011-11-25

Colloidal carriers are known to improve the therapeutic index of the conventional drugs in the treatment of visceral leishmaniasis (VL) by decreasing their toxicity whilst maintaining or increasing therapeutic efficacy. This paper describes the development of poly(d,l-lactide-co-glycolide) (PLGA) nanoparticles (NPs) for the antileishmanial saponin β-aescin. NPs were prepared by the W/O/W emulsification solvent evaporation technique and the influence of five preparation parameters on the NPs' size (Z(ave)), zeta potential and entrapment efficiency (EE%) was investigated using a 2(5-2) fractional factorial design. Cytotoxicity of aescin, aescin-loaded and blank PLGA NPs was evaluated in J774 macrophages and non-phagocytic MRC-5 cells, whereas antileishmanial activity was determined in the Leishmania infantum ex vivo model. The developed PLGA NPs were monodispersed with Z(ave)<500 nm and exhibited negative zeta potentials. The process variables 'surfactant primary emulsion', 'concentration aescin' and 'solvent evaporation rate' had a positive effect on EE%. Addition of Tween 80 to the inner aqueous phase rendered the primary emulsion more stable, which in its turn led to better saponin entrapment. The selectivity index (SI) towards the supporting host macrophages increased from 4 to 18 by treating the cells with aescin-loaded NPs instead of free β-aescin. In conclusion, the in vitro results confirmed our hypothesis. Copyright © 2011 Elsevier B.V. All rights reserved.

Epidural blood patch for refractory low CSF pressure headache: a pilot study.

PubMed

Madsen, Søren Aalbæk; Fomsgaard, Jonna Storm; Jensen, Rigmor

2011-08-01

Once believed an exceedingly rare disorder, recent evidence suggests that low cerebrospinal fluid (CSF) pressure headache has to be considered an important cause of new daily persistent headaches, particularly among young and middle-aged individuals. Treatment of low CSF pressure headache consists of non-invasive/conservative measures and invasive measures with epidural blood patch providing the cornerstone of the invasive measures. In the present pilot study we therefore aimed to evaluate the treatment efficacy of epidural blood patch (EBP) in treatment-refractory low-pressure headache. Our primary effect parameter was total headache burden defined as area under the curve (AUC: intensity × duration) and as secondary effect parameters we identified: intensity (VAS 0-10), frequency (days per month), duration in hours (total hours/month) and also medication days (days on medication/month). In our primary effect parameter we found a significant reduction in AUC with more than 25% and this is considered to be clinically relevant. We found also a significant and relevant reduction at -22% in intensity. A trend towards reduction in duration was seen. We found no statistically significant reduction in frequency. An increase in days with use of medication was found. Increased awareness of low CSF pressure headache is emphasized and a controlled larger randomized study is needed to confirm the results. However the present results, allows us to conclude that EBP in treatment-refractory low CSF pressure headache can be considered as a treatment option.

[Postmarketing study of efficacy and safety of losartan during the treatment of patients with mild and moderate hypertension: LOTAR (corrected) study].

PubMed

Vasilijević, Zorana; Dimković, Nada; Lazarević, Katarina; Burmazović, Snežana; Krstić, Nebojša; Milanović, Sladjan; Zorić, Svetlana; Micić, Dragan

2013-01-01

Losartan, the angiotensin type 1 receptor blocker (ARB) exercises its main antihypertensive effect by vasodilatation of peripheral arteries. The aim of this study was to evaluate the antihypertensive effect and safety of losartan in patients with mild and moderate arterial hypertension (AH). This was an open post-marketing study with losartan as monotherapy in previously treated or untreated patients with AH. Primary efficacy parameter was the percentage of patients that achieved target blood pressure after 8-week treatment with a single daily dose of losartan of 50-100 mg. Safety parameters were assessed according to the percentage of adverse events and metabolic effects of therapy. The study included 550 patients with AH (59% female and 41% male), mean age 56.8 +/-11.4 years, BMI = 27 +/- 4 kg/m2. Losartan was applied in 31% of untreated and 69% of previously treatment-resistant patients After 8 weeks target blood pressure was achieved in 67.8% (SBP) and in 81.1% (DBP) of patients, respectively. The mean decrease was 21.8% for SBP and 21.1% for DBP (p < 0.001). Out of all, 65% of patients achieved both target SBP and DBP values. Hydrochlorothiazide was added to the therapy in 11.6% of patients. There were no significant differences in drug efficacy between the entire group and subgroups of patients with diabetes mellitus and impaired renal function (p = ns). Adverse events were rare and metabolic effect was favorable. Monotherapy with losartan in a dosage of 50-100 mg applied during 8 weeks resulted in achieving target values of blood pressure in 65% of patient with mild and moderate hypertension, also including the patients with diabetes mellitus and impaired renal function. Losartan is a safe and metabolically neutral medication.

Exploring Primary Teachers' Self-Efficacy Beliefs for Teaching Dance Education

ERIC Educational Resources Information Center

Renner, Suzanne; Pratt, Keryn

2017-01-01

The self-efficacy beliefs of 140 generalist teachers for teaching dance in the New Zealand curriculum were surveyed using an adapted version of the Teachers' Sense of Self-efficacy scale (TSES) developed by Tschannen-Moran and Woolfolk Hoy (2001). Four hypotheses were created to test relationships between the participants' self-efficacy beliefs…

Asthma management self-efficacy in parents of primary school-age children.

PubMed

Brown, Nicola; Gallagher, Robyn; Fowler, Cathrine; Wales, Sandra

2014-06-01

The aim of this study was to investigate asthma management self-efficacy in parents of primary school-age children with asthma and to explore possible associations between parent asthma management self-efficacy, parent and child characteristics, asthma task difficulty and asthma management responsibility. A cross-sectional descriptive survey of 113 parents was conducted to assess the level of parent asthma management self-efficacy, asthma task difficulty and confidence, asthma responsibility and socio-demographic characteristics. The findings indicate that parents had higher self-efficacy for attack prevention than attack management. Parents had higher self-efficacy for asthma management tasks that are simple, skills based and performed frequently such as medication administration and less confidence and greater difficulty with tasks associated with judgement and decision-making. Multivariate linear regression analysis identified English language, child asthma responsibility and parent education as predictors of higher asthma management self-efficacy, while an older child was associated with lower parent asthma management self-efficacy. The implications of these results for planning and targeting health education and self-management interventions for parents and children are discussed. © The Author(s) 2013.

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

PubMed

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.

A study protocol testing the implementation, efficacy, and cost effectiveness of the ezParent program in pediatric primary care

PubMed Central

Schoeny, Michael; Risser, Heather; Johnson, Tricia

2016-01-01

Introduction Up to 20% of children demonstrate behavior problems that interfere with relationship development and academic achievement. Parent participation in behavioral parent training programs has been shown to decrease child problem behaviors and promote positive parent-child relationships. However, attendance and parent involvement in face-to-face parent training remain low. Testing the implementation, efficacy, and cost of alternative delivery models is needed to (a) increase the reach and sustainability of parent training interventions and (b) address the barriers to parent participation and implementation of such programs, specifically in primary health care settings. The purpose of this paper is to describe the study protocol evaluating the implementation, efficacy, and cost-effectiveness of delivering the tablet-based ezParent program in pediatric primary care sites. Methods The implementation of the ezParent in four pediatric primary care sites will be evaluated using a descriptive design and cost-effectiveness analysis. The efficacy of the ezParent will be tested using a randomized controlled trial design with 312 parents of 2 to 5 year old children from pediatric primary care settings. Data on parenting and child behavior outcomes will be obtained from all participants at baseline, and 3, 6, and 12 months post baseline. Discussion Integrating and evaluating the implementation of the ezParent in pediatric primary care is an innovative opportunity to promote positive parenting with potential for universal access to the preschool population and for low cost by building on existing infrastructure in pediatric primary care. PMID:27592122

Mindfulness as a complementary intervention in the treatment of overweight and obesity in primary health care: study protocol for a randomised controlled trial.

PubMed

Salvo, Vera; Kristeller, Jean; Marin, Jesus Montero; Sanudo, Adriana; Lourenço, Bárbara Hatzlhoffer; Schveitzer, Mariana Cabral; D'Almeida, Vania; Morillo, Héctor; Gimeno, Suely Godoy Agostinho; Garcia-Campayo, Javier; Demarzo, Marcelo

2018-05-11

Mindfulness has been applied in the United States and Europe to improve physical and psychological health; however, little is known about its feasibility and efficacy in a Brazilian population. Mindfulness may also be relevant in tackling obesity and eating disorders by decreasing binge eating episodes-partly responsible for weight regain for a large number of people-and increasing awareness of emotional and other triggers for overeating. The aim of the present study protocol is to evaluate and compare the feasibility and efficacy of two mindfulness-based interventions (MBIs) addressing overweight and obesity in primary care patients: a general programme called Mindfulness-Based Health Promotion and a targeted mindful eating protocol called Mindfulness-Based Eating Awareness Training. A randomised controlled trial will be conducted to compare treatment as usual separately in primary care with both programmes (health promotion and mindful eating) added to treatment as usual. Two hundred forty adult women with overweight and obesity will be enrolled. The primary outcome will be an assessment of improvement in eating behaviour. Secondary outcomes will be (1) biochemical control; (2) anthropometric parameters, body composition, dietary intake and basal metabolism; and (3) levels of mindfulness, stress, depression, self-compassion and anxiety. At the end of each intervention, a focus group will be held to assess the programme's impact on the participants' lives, diet and health. A feasibility study on access to benefits from and importance of MBIs at primary care facilities will be conducted among primary care health care professionals and participants. Monthly maintenance sessions lasting at least 1 hour will be offered, according to each protocol, during the 3-month follow-up periods. This clinical trial will result in more effective mindfulness-based interventions as a complementary treatment in primary care for people with overweight and obesity. If the findings of this study confirm the effectiveness of mindfulness programmes in this population, it will be possible to improve quality of life and health while optimising public resources and reaching a greater number of people. In addition, on the basis of the evaluation of the feasibility of implementing this intervention in primary care facilities, we expect to be able to suggest the intervention for incorporation into public policy. ClinicalTrials.gov, NCT02893150 . Registered retrospectively on 30 March 2017.

The influence of bile salt on the chemotherapeutic response of docetaxel-loaded thermosensitive nanomicelles.

PubMed

Kim, Dong Wuk; Ramasamy, Thiruganesh; Choi, Ju Yeon; Kim, Jeong Hwan; Yong, Chul Soon; Kim, Jong Oh; Choi, Han-Gon

2014-01-01

The primary aim of this work was to investigate the potential of bile salt, sodium taurocholate (NaTC), in improving the bioavailability and anti-tumor efficacy of docetaxel (DCT) upon rectal administration. Poloxamer-based nanomicelles with thermosensitive and mucoadhesive properties were prepared using the cold method. The optimized nanomicellar formulation was evaluated in terms of physicochemical and viscoelastic parameters. Nanomicelles containing bile salt maintained sufficient gelation strength (234×10(2) mPa·s) and mucoadhesive force (17.3×10(2) dyne/cm(2)) to be retained in the upper part of the rectum. They significantly enhanced the DCT internalization across the rectal mucosa and showed a high plasma level during the first 4 hours of the study period, compared to nanomicelles with no bile salt. As a result, a slightly higher rectal bioavailability of ~33% was observed in nanomicelles containing bile salt, compared to ~28% from the latter system. The higher pharmacokinetic parameters for rectally administered DCT/P407/P188/Tween 80/NaTC (0.25%/11%/15%/10%/0.1% by weight, respectively) resulted in significant anti-tumor efficacy. However, the tumor regression rate for the NaTC group was not statistically different from that for nanomicelles without NaTC. Therefore, overall results suggest that thermosensitive nanomicelles could be a potential dosage form for improvement of the bioavailability and chemotherapeutic profile of DCT.

The influence of bile salt on the chemotherapeutic response of docetaxel-loaded thermosensitive nanomicelles

PubMed Central

Kim, Dong Wuk; Ramasamy, Thiruganesh; Choi, Ju Yeon; Kim, Jeong Hwan; Yong, Chul Soon; Kim, Jong Oh; Choi, Han-Gon

2014-01-01

The primary aim of this work was to investigate the potential of bile salt, sodium taurocholate (NaTC), in improving the bioavailability and anti-tumor efficacy of docetaxel (DCT) upon rectal administration. Poloxamer-based nanomicelles with thermosensitive and mucoadhesive properties were prepared using the cold method. The optimized nanomicellar formulation was evaluated in terms of physicochemical and viscoelastic parameters. Nanomicelles containing bile salt maintained sufficient gelation strength (234×102 mPa·s) and mucoadhesive force (17.3×102 dyne/cm2) to be retained in the upper part of the rectum. They significantly enhanced the DCT internalization across the rectal mucosa and showed a high plasma level during the first 4 hours of the study period, compared to nanomicelles with no bile salt. As a result, a slightly higher rectal bioavailability of ~33% was observed in nanomicelles containing bile salt, compared to ~28% from the latter system. The higher pharmacokinetic parameters for rectally administered DCT/P407/P188/Tween 80/NaTC (0.25%/11%/15%/10%/0.1% by weight, respectively) resulted in significant anti-tumor efficacy. However, the tumor regression rate for the NaTC group was not statistically different from that for nanomicelles without NaTC. Therefore, overall results suggest that thermosensitive nanomicelles could be a potential dosage form for improvement of the bioavailability and chemotherapeutic profile of DCT. PMID:25143730

Pirfenidone for the treatment of Hermansky-Pudlak Syndrome pulmonary fibrosis

PubMed Central

O’Brien, Kevin; Troendle, James; Gochuico, Bernadette R.; Markello, Thomas C.; Salas, Jose; Cardona, Hilda; Yao, Jianhua; Bernardini, Isa; Hess, Richard; Gahl, William A.

2013-01-01

Hermansky-Pudlak syndrome (HPS) type is a rare disorder of oculocutaneous albinism, platelet dysfunction, and in some subtypes, fatal pulmonary fibrosis. There is no effective treatment for the pulmonary fibrosis except lung transplantation, but an initial trial using pirfenidone, an anti-fibrotic agent, showed promising results. The current, randomized, placebo-controlled, prospective, double-blind trial investigated the safety and efficacy of pirfenidone for mild to moderate HPS-1 and 4 pulmonary fibrosis. Subjects were evaluated every 4 months at the National Institutes of Health Clinical Center, and the primary outcome parameter was change in forced vital capacity using repeated measures analysis with random coefficients. Thirty-five subjects with HPS-1 pulmonary fibrosis were enrolled during a 4-year interval; 23 subjects received pirfenidone and 12 received placebo. Four subjects withdrew from the trial, 3 subjects died, and 10 serious adverse events were reported. Both groups experienced similar side effects, especially gastroesophageal reflux. Interim analysis of the primary outcome parameter, performed 12 months after 30 patients were enrolled, showed no statistical difference between the placebo and pirfenidone groups, and the study was stopped due to futility. There were no significant safety concerns. Other clinical trials are indicated to identify single or multiple drug regimens that may be effective in treatment for progressive HPS-1 pulmonary fibrosis. PMID:21420888

Using Self-Efficacy to Measure Primary School Teachers' Perception of ICT: Results from Two Studies

ERIC Educational Resources Information Center

Fanni, F.; Rega, I.; Cantoni, L.

2013-01-01

The aim of this article is twofold. First, the final results of two research projects, which investigated the impact of Information and Communication Technology (ICT) on primary schools teachers in disadvantaged areas in Brazil (BET k-12) and South Africa (MELISSA), are presented and discussed. Second, the Self-Efficacy construct is proposed as a…

Perception of Teaching Efficacy by Primary and Secondary School Teachers

ERIC Educational Resources Information Center

Bedir, Gülay

2015-01-01

This research aims to identify how teaching efficacy is perceived by teachers working at state schools. Having a survey model design, this study hosts a total of 678 primary and secondary school teachers--401 females and 277 males--working in the province of Tokat during the academic year of 2013 and 2014. Research data has been collected through…

Determination of the Computer Self-Efficacy Perception of Students and Metaphors Related to "Computer Ownership"

ERIC Educational Resources Information Center

Gecer, Aynur

2013-01-01

The aim of this research is to determine the computer self-efficacy perception of second grade primary school students and their opinions regarding computer ownership through metaphors. The research applied the scanning model and was conducted during the 2011-2012 academic year among seven primary schools of the Ministry of National Education in…

An Investigation into the Perceptions of Mathematics and Information Literacy Self-Efficacy Levels of Pre-Service Primary Mathematics Teachers

ERIC Educational Resources Information Center

Dinçer, Bahar; Yilmaz, Süha

2016-01-01

The purpose of this study is to examine the relationship between perceptions of the self-efficacy levels for both mathematics literacy and information literacy in pre-service primary mathematics teachers and the factors on which the relationship depends (variables include gender, class level, hours spent reading books and computer-access…

The use of group sequential, information-based sample size re-estimation in the design of the PRIMO study of chronic kidney disease.

PubMed

Pritchett, Yili; Jemiai, Yannis; Chang, Yuchiao; Bhan, Ishir; Agarwal, Rajiv; Zoccali, Carmine; Wanner, Christoph; Lloyd-Jones, Donald; Cannata-Andía, Jorge B; Thompson, Taylor; Appelbaum, Evan; Audhya, Paul; Andress, Dennis; Zhang, Wuyan; Solomon, Scott; Manning, Warren J; Thadhani, Ravi

2011-04-01

Chronic kidney disease is associated with a marked increase in risk for left ventricular hypertrophy and cardiovascular mortality compared with the general population. Therapy with vitamin D receptor activators has been linked with reduced mortality in chronic kidney disease and an improvement in left ventricular hypertrophy in animal studies. PRIMO (Paricalcitol capsules benefits in Renal failure Induced cardia MOrbidity) is a multinational, multicenter randomized controlled trial to assess the effects of paricalcitol (a selective vitamin D receptor activator) on mild to moderate left ventricular hypertrophy in patients with chronic kidney disease. Subjects with mild-moderate chronic kidney disease are randomized to paricalcitol or placebo after confirming left ventricular hypertrophy using a cardiac echocardiogram. Cardiac magnetic resonance imaging is then used to assess left ventricular mass index at baseline, 24 and 48 weeks, which is the primary efficacy endpoint of the study. Because of limited prior data to estimate sample size, a maximum information group sequential design with sample size re-estimation is implemented to allow sample size adjustment based on the nuisance parameter estimated using the interim data. An interim efficacy analysis is planned at a pre-specified time point conditioned on the status of enrollment. The decision to increase sample size depends on the observed treatment effect. A repeated measures analysis model, using available data at Week 24 and 48 with a backup model of an ANCOVA analyzing change from baseline to the final nonmissing observation, are pre-specified to evaluate the treatment effect. Gamma-family of spending function is employed to control family-wise Type I error rate as stopping for success is planned in the interim efficacy analysis. If enrollment is slower than anticipated, the smaller sample size used in the interim efficacy analysis and the greater percent of missing week 48 data might decrease the parameter estimation accuracy, either for the nuisance parameter or for the treatment effect, which might in turn affect the interim decision-making. The application of combining a group sequential design with a sample-size re-estimation in clinical trial design has the potential to improve efficiency and to increase the probability of trial success while ensuring integrity of the study.

Long-term effect of latanoprost/timolol fixed combination in patients with glaucoma or ocular hypertension: A prospective, observational, noninterventional study

PubMed Central

2010-01-01

Background Prospective, observational studies that enroll large numbers of patients with few exclusion criteria may better reflect actual ongoing clinical experience than randomized clinical trials. Our purpose was to obtain efficacy and safety information from a cohort of subjects exposed to latanoprost/timolol fixed combination (FC) for ≥18 months using a prospective, observational design. Methods In all, 577 office-based ophthalmologists in Germany switched 2339 patients with glaucoma or ocular hypertension to latanoprost/timolol FC for medical reasons. Follow-up visits were scheduled for every 6 months over 24 months; physicians followed usual care routines. Intraocular pressure (IOP), visual field status, optic nerve head findings, and adverse events were recorded. Efficacy parameters were evaluated for the per protocol (PP) population; the safety population included subjects receiving ≥1 drop of FC. Physicians rated efficacy, tolerability, and subject compliance at month 24. Results Of the 2339 subjects switched to latanoprost/timolol FC (safety population), the primary reasons for switching were inadequate IOP reduction (78.2%) and desire to simplify treatment with once-daily dosing (29.4%; multiple reasons possible). In all, 1317 (56.3%) subjects completed the study, and 1028 (44.0%) were included in the PP population. Most discontinuations were due to loss to follow-up. Change in mean IOP from baseline to month 6 was -4.0 ± 4.31 mmHg, a reduction that was maintained throughout (P < 0.05 for change at all time points). By investigator assessments, optic disc parameters and visual field were stable over 24 months, and there was no relationship between IOP reduction over 24 months and development of a visual field defect. More than 90% of physicians rated latanoprost/timolol FC as "very good" or "good" for efficacy (PP population), tolerability, and compliance. The FC was safe and well tolerated. No change in iris color was reported by most subjects (83.1%) at month 24. Conclusions Over 24 months, latanoprost/timolol FC effectively lowers IOP levels and is well tolerated in patients with glaucoma or ocular hypertension who change from their previous ocular hypotensive therapy for medical reasons. Investigator assessments found optic disc parameters and visual field to be stable throughout 24 months of follow-up. PMID:20825668

A framework for prescription in exercise-oncology research†

PubMed Central

Sasso, John P; Eves, Neil D; Christensen, Jesper F; Koelwyn, Graeme J; Scott, Jessica; Jones, Lee W

2015-01-01

The field of exercise-oncology has increased dramatically over the past two decades, with close to 100 published studies investigating the efficacy of structured exercise training interventions in patients with cancer. Of interest, despite considerable differences in study population and primary study end point, the vast majority of studies have tested the efficacy of an exercise prescription that adhered to traditional guidelines consisting of either supervised or home-based endurance (aerobic) training or endurance training combined with resistance training, prescribed at a moderate intensity (50–75% of a predetermined physiological parameter, typically age-predicted heart rate maximum or reserve), for two to three sessions per week, for 10 to 60 min per exercise session, for 12 to 15 weeks. The use of generic exercise prescriptions may, however, be masking the full therapeutic potential of exercise treatment in the oncology setting. Against this background, this opinion paper provides an overview of the fundamental tenets of human exercise physiology known as the principles of training, with specific application of these principles in the design and conduct of clinical trials in exercise-oncology research. We contend that the application of these guidelines will ensure continued progress in the field while optimizing the safety and efficacy of exercise treatment following a cancer diagnosis. PMID:26136187

A Climate for Self-Efficacy: The Relationship between School Climate and Teacher Efficacy for Inclusion

ERIC Educational Resources Information Center

Hosford, Susan; O'Sullivan, Siobhán

2016-01-01

Teacher efficacy represents a key construct in exploring successful implementation of inclusive policy. Teachers' impression of school climate is shown to relate to teacher efficacy; however, few studies pay due deference to its context/specific conceptualisation, with a particular lacuna in research noted in an Irish mainstream primary school…

Improving Fifth Grade Students' Mathematics Self-Efficacy Calibration and Performance through Self-Regulation Training

ERIC Educational Resources Information Center

Ramdass, Darshanand H.

2009-01-01

This primary goal of this study was to investigate the effects of strategy training and self-reflection, two subprocesses of Zimmerman's cyclical model of self-regulation, on fifth grade students' mathematics performance, self-efficacy, self-evaluation, and calibration measures of self-efficacy bias, self-efficacy accuracy, self-evaluation bias,…

Advanced Practice Pharmacists: a retrospective evaluation of the efficacy and cost of ClinicaL Pharmacist PractitionErs managing ambulatory Medicare patients in North Carolina (APPLE-NC).

PubMed

Kislan, Michèle M; Bernstein, Adam T; Fearrington, Loretta R; Ives, Timothy J

2016-10-21

Clinical Pharmacist Practitioners are advanced practicing pharmacists in North Carolina that provide disease-specific management. The purpose of this retrospective cohort study was to compare the efficacy and charges from referrals to a Clinical Pharmacist Practitioner by the primary care provider, to those managed by a primary care provider alone. Patients were separated into cohorts depending if they had at least two appointments with a Clinical Pharmacist Practitioner from November 2008 to November 2011. A primary care provider saw all patients at least twice during the study period. Cohorts were then matched by age, gender, and disease states. Medicare billed data was evaluated from outpatient visits related to hypertension, diabetes mellitus, and peripheral neuropathy, as well as emergency department visits and inpatient admissions. Cost of medications was estimated using 2009 AWP data corresponding to medication histories within the electronic medical record. Efficacy was defined as ability to reach disease state goal determined using national guidelines and reduction in pain score. Efficacy was analyzed by difference-in-differences test and all other numerical data tested by paired t-tests. The Clinical Pharmacist Practitioners cohort experienced more outpatient visits (1338 vs. 858, p < 0.001), fewer emergency department visits (115 vs. 190, p < 0.05), and similar inpatient admissions (88 vs. 117, p > 0.05) than the primary care providers cohort, respectively. The Clinical Pharmacist Practitioners cohort showed changes in charges of +22.6 % for outpatient visits, -45.5 % emergency department visits, and -13.2 % inpatient admissions relative to the primary care provider cohort. There was no difference in average daily medication cost (Clinical Pharmacist Practitioners $38.52 vs. primary care providers $38.23, p = 0.97) or achievement of disease state goals. APPLE-NC demonstrated that through referrals, Clinical Pharmacist Practitioners provide services comparable in charges and efficacy to primary care providers. Consequently, the current increased need for primary care practitioners can be met in part by increasing the utilization of advanced practice pharmacists for chronic disease management. This does not apply for this retrospective cohort study.

An in vivo comparison of antimicrobial efficacy of sodium hypochlorite and Biopure MTAD™ against enterococcus faecalis in primary teeth: A qPCR study.

PubMed

Tulsani, S G; Chikkanarasaiah, N; Bethur, S

2014-01-01

Biopure MTAD™, a new root canal irrigant has shown promising results against the most common resistant microorganism, E. faecalis, in permanent teeth. However, there is lack of studies comparing its antimicrobial effectiveness with NaOCl in primary teeth. The purpose of this study was to compare the in vivo antimicrobial efficacy of NaOCl 2.5% and Biopure MTAD™ against E. faecalis in primary teeth. Forty non vital single rooted primary maxillary anterior teeth of children aged 4-8 years, were irrigated either with NaOCl 2.5% (n=15), Biopure MTAD™ (n=15) and 0.9% Saline (n=10, control group). Paper point samples were collected at baseline (S1) and after chemomechanical preparation (S2) during the pulpectomy procedure. The presence of E. faecalis in S1 & S2 was evaluated using Real time Polymerase Chain Reaction. Statistical significant difference was found in the antimicrobial efficacy of NaOCl 2.5 % and BioPure MTAD™ when compared to saline (p>0.05). However, no statistical significant difference was found between the efficacies of both the irrigants. NaOCl 2.5% and BioPure MTAD™, both irrigants are equally efficient against E. faecalis in necrotic primary anterior teeth. MTAD is a promising irrigant, however clinical studies are required to establish it as ideal root canal irrigant in clinical practice.

Gender Differences in the Efficacy and Safety of Chronic Nightly Zolpidem

PubMed Central

Roehrs, Timothy A.; Roth, Thomas

2016-01-01

Study Objectives: Studies have shown pharmacokinetic differences for hypnotics in women compared to men, but few studies have assessed either short-or long-term differences in efficacy and safety. Methods: To evaluate gender differences in the efficacy and safety of chronic nightly zolpidem (10 mg), we did a post hoc assessment of a large clinical trial. In the trial, participants with primary insomnia (n = 89), ages 23–70, meeting DSM-IV-TR criteria for primary insomnia were randomized, double blind, to nightly zolpidem, 10 mg (n = 47) or placebo (n = 42) 30 minutes before bedtime nightly for 12 months. Polysomnographic sleep on 2 nights in months 1 and 8 and likelihood of next-day sleepiness, rebound insomnia, and dose escalation were evaluated in months 1, 4, and 12. Results: Relative to placebo, zolpidem significantly increased sleep efficiency and reduced sleep latency and wake after sleep onset assessed at months 1 and 8, with no differences in efficacy between women and men and no diminution of efficacy over months. On a next-day multiple sleep latency test (MSLT), no residual sedation was observed for either women or men. No rebound insomnia or dose escalation was seen with no gender differences in either. Conclusions: In adults with primary insomnia, nightly zolpidem administration showed no gender differences in acute or chronic efficacy or in next-day sleepiness. Zolpidem remained efficacious and safe across 12 months. Clincial Trials Registration: ClinicalTrials.gov Identifier: NCT01006525; Trial Name: Safety and Efficacy of Chronic Hypnotic Use; http://clinicaltrials.gov/ct2/show/NCT01006525. Citation: Roehrs TA, Roth T. Gender differences in the efficacy and safety of chronic nightly zolpidem. J Clin Sleep Med 2016;12(3):319–325. PMID:26446253

Food Insecurity Associated with Self-Efficacy and Acculturation.

PubMed

Kamimura, Akiko; Jess, Allison; Trinh, Ha N; Aguilera, Guadalupe; Nourian, Maziar M; Assasnik, Nushean; Ashby, Jeanie

2017-02-01

Food insecurity is a significant public health issue that affects the physical and mental health of people of all ages. Higher levels of self-efficacy may reduce levels of food insecurity. In addition, acculturation is potentially an important factor for food insecurity among immigrant populations. The purpose of this study is to examine food insecurity associated with self-efficacy and acculturation among low-income primary care patients in the United States. A self-administered survey was administered in May and June 2015 to uninsured primary care patients (N = 551) utilizing a free clinic that provides free primary care services to low-income uninsured individuals and families in the United States. On average, participants reported low food security. Higher levels of self-efficacy were associated with lower levels of food insecurity. Higher levels of heritage language proficiency were related to lower levels of food insecurity. US-born English speakers, women, and unmarried individuals potentially have higher risks of food insecurity and may need interventions to meet their specific needs. Self-efficacy should be included in nutrition education programs to reduce the levels of food insecurity. Future studies should further examine why these groups have a high risk to better understand needs for interventions.

Gender Differences in the Efficacy and Safety of Chronic Nightly Zolpidem.

PubMed

Roehrs, Timothy A; Roth, Thomas

2016-03-01

Studies have shown pharmacokinetic differences for hypnotics in women compared to men, but few studies have assessed either short-or long-term differences in efficacy and safety. To evaluate gender differences in the efficacy and safety of chronic nightly zolpidem (10 mg), we did a post hoc assessment of a large clinical trial. In the trial, participants with primary insomnia (n = 89), ages 23-70, meeting DSM-IV-TR criteria for primary insomnia were randomized, double blind, to nightly zolpidem, 10 mg (n = 47) or placebo (n = 42) 30 minutes before bedtime nightly for 12 months. Polysomnographic sleep on 2 nights in months 1 and 8 and likelihood of next-day sleepiness, rebound insomnia, and dose escalation were evaluated in months 1, 4, and 12. Relative to placebo, zolpidem significantly increased sleep efficiency and reduced sleep latency and wake after sleep onset assessed at months 1 and 8, with no differences in efficacy between women and men and no diminution of efficacy over months. On a next-day multiple sleep latency test (MSLT), no residual sedation was observed for either women or men. No rebound insomnia or dose escalation was seen with no gender differences in either. In adults with primary insomnia, nightly zolpidem administration showed no gender differences in acute or chronic efficacy or in next-day sleepiness. Zolpidem remained efficacious and safe across 12 months. CLINCIAL TRIALS REGISTRATION: ClinicalTrials.gov Identifier: NCT01006525; Trial Name: Safety and Efficacy of Chronic Hypnotic Use; http://clinicaltrials.gov/ct2/show/NCT01006525. © 2016 American Academy of Sleep Medicine.

Is balneotherapy effective for fibromyalgia? Results from a 6-month double-blind randomized clinical trial.

PubMed

Fioravanti, Antonella; Manica, Patrizia; Bortolotti, Roberto; Cevenini, Gabriele; Tenti, Sara; Paolazzi, Giuseppe

2018-05-05

The aim of this study was to assess the efficacy and tolerability of balneotherapy (BT) in patients with primary fibromyalgia syndrome (FS). In a prospective, randomized, controlled, double-blind trial with a 6-month follow-up, 100 FS patients were randomized to receive a cycle of BT with highly mineralized sulfate water (BT group) or with tap water (control group). Clinical assessments were performed at screening visit, at basal time, and after treatment (2 weeks, 3 and 6 months). The primary outcome measures were the change of global pain on the Visual Analogue Scale (VAS) and Fibromyalgia Impact Questionnaire total score (FIQ-Total) from baseline to 15 days. Secondary outcomes included Widespread Pain Index, Symptom Severity Scale Score, Short Form Health Survey, State-Trait Anxiety Inventory (STAI), and Center for Epidemiologic Studies Depression Scale. We performed an intent-to-treat analysis. The Kolmogorov-Smirnov test was applied to verify the normality distribution of all quantitative variables and the Student's t test to compare sample data. In the BT group, we observed a significant improvement of VAS and FIQ-Total at the end of the treatment that persisted until 6 months, while no significant differences were found in the control group. The differences between groups were significant for primary parameters at each time point. Similar results were obtained for the other secondary outcomes except for the STAI outcome. Adverse events were reported by 10 patients in the BT group and by 22 patients in the control group. Our results support the short- and long-term therapeutic efficacy of BT in FS. NCT02548065.

Investigation of Teachers' Mathematics Teaching Self-Efficacy

ERIC Educational Resources Information Center

Nurlu, Özge

2015-01-01

The aim of this research is to investigate primary school teachers' characteristics by comparing their mathematics teaching self-efficacy beliefs. In this research, qualitative research method is used. In order to determine the participant teachers, firstly, "Self-Efficacy Beliefs toward Mathematics Teaching Scale" (Dede, 2008) was…

The Effect of Primary School Students' Writing Attitudes and Writing Self-Efficacy Beliefs on Their Summary Writing Achievement

ERIC Educational Resources Information Center

Bulut, Pinar

2017-01-01

In this study, the effect of writing attitude and writing self-efficacy beliefs on the summarization achievement of the 4th grade primary school students was examined using the structural equation modeling. The study employed the relational survey model. The study group constructed by means of simple random sampling method is comprised of 335…

Galvanostatic Intermittent Titration and Performance Based Analysis of LiNi 0.5 Co 0.2 Mn 0.3 O 2 Cathode

DOE Office of Scientific and Technical Information (OSTI.GOV)

Verma, Ankit; Smith, Kandler; Santhanagopalan, Shriram

Galvanostatic intermittent titration technique (GITT) - a popular method for characterizing kinetic and transport properties of battery electrodes - is predicated on the proper evaluation of electrode active area. LiNi 0.5044Co 0.1986Mn 0.2970O 2 (NCM523) material exhibits a complex morphology in which sub-micron primary particles aggregate to form secondary particle agglomerates. Our work proposes a new active area formulation for primary/secondary particle agglomerate materials to better mimic the morphology of NCM532 electrodes. Furthermore, this formulation is then coupled with macro-homogeneous models to simulate GITT and half-cell performance of NCM523 electrodes. Subsequently, the model results are compared against the experimental resultsmore » to refine the area formulation. A single parameter, the surface roughness factor, is proposed to mimic the change in interfacial area, diffusivity and exchange current density simultaneously and detailed modeling results are presented to provide valuable insights into the efficacy of the formulation.« less

Galvanostatic Intermittent Titration and Performance Based Analysis of LiNi 0.5Co 0.2 Mn 0.3O 2Cathode

DOE Office of Scientific and Technical Information (OSTI.GOV)

Verma, Ankit; Smith, Kandler; Santhanagopalan, Shriram

Galvanostatic intermittent titration technique (GITT) – a popular method for characterizing kinetic and transport properties of battery electrodes – is predicated on the proper evaluation of electrode active area. LiNi0.5044Co0.1986Mn0.2970O2 (NCM523) material exhibits a complex morphology in which sub-micron primary particles aggregate to form secondary particle agglomerates. This work proposes a new active area formulation for primary/secondary particle agglomerate materials to better mimic the morphology of NCM532 electrodes. This formulation is then coupled with macro-homogeneous models to simulate GITT and half-cell performance of NCM523 electrodes. Subsequently, the model results are compared against the experimental results to refine the area formulation.more » A single parameter, the surface roughness factor, is proposed to mimic the change in interfacial area, diffusivity and exchange current density simultaneously and detailed modeling results are presented to provide valuable insights into the efficacy of the formulation.« less

Galvanostatic Intermittent Titration and Performance Based Analysis of LiNi 0.5 Co 0.2 Mn 0.3 O 2 Cathode

DOE PAGES

Verma, Ankit; Smith, Kandler; Santhanagopalan, Shriram; ...

2017-11-03

Galvanostatic intermittent titration technique (GITT) - a popular method for characterizing kinetic and transport properties of battery electrodes - is predicated on the proper evaluation of electrode active area. LiNi 0.5044Co 0.1986Mn 0.2970O 2 (NCM523) material exhibits a complex morphology in which sub-micron primary particles aggregate to form secondary particle agglomerates. Our work proposes a new active area formulation for primary/secondary particle agglomerate materials to better mimic the morphology of NCM532 electrodes. Furthermore, this formulation is then coupled with macro-homogeneous models to simulate GITT and half-cell performance of NCM523 electrodes. Subsequently, the model results are compared against the experimental resultsmore » to refine the area formulation. A single parameter, the surface roughness factor, is proposed to mimic the change in interfacial area, diffusivity and exchange current density simultaneously and detailed modeling results are presented to provide valuable insights into the efficacy of the formulation.« less

The Efficacy of Mindfulness-Based Interventions in Primary Care: A Meta-Analytic Review.

PubMed

Demarzo, Marcelo M P; Montero-Marin, Jesús; Cuijpers, Pim; Zabaleta-del-Olmo, Edurne; Mahtani, Kamal R; Vellinga, Akke; Vicens, Caterina; López-del-Hoyo, Yolanda; García-Campayo, Javier

2015-11-01

Positive effects have been reported after mindfulness-based interventions (MBIs) in diverse clinical and nonclinical populations. Primary care is a key health care setting for addressing common chronic conditions, and an effective MBI designed for this setting could benefit countless people worldwide. Meta-analyses of MBIs have become popular, but little is known about their efficacy in primary care. Our aim was to investigate the application and efficacy of MBIs that address primary care patients. We performed a meta-analytic review of randomized controlled trials addressing the effect of MBIs in adult patients recruited from primary care settings. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and Cochrane guidelines were followed. Effect sizes were calculated with the Hedges g in random effects models. The meta-analyses were based on 6 trials having a total of 553 patients. The overall effect size of MBI compared with a control condition for improving general health was moderate (g = 0.48; P = .002), with moderate heterogeneity (I(2) = 59; P <.05). We found no indication of publication bias in the overall estimates. MBIs were efficacious for improving mental health (g = 0.56; P = .007), with a high heterogeneity (I(2) = 78; P <.01), and for improving quality of life (g = 0.29; P = .002), with a low heterogeneity (I(2) = 0; P >.05). Although the number of randomized controlled trials applying MBIs in primary care is still limited, our results suggest that these interventions are promising for the mental health and quality of life of primary care patients. We discuss innovative approaches for implementing MBIs, such as complex intervention and stepped care. © 2015 Annals of Family Medicine, Inc.

The Efficacy of Mindfulness-Based Interventions in Primary Care: A Meta-Analytic Review

PubMed Central

Demarzo, Marcelo M.P.; Montero-Marin, Jesús; Cuijpers, Pim; Zabaleta-del-Olmo, Edurne; Mahtani, Kamal R.; Vellinga, Akke; Vicens, Caterina; López-del-Hoyo, Yolanda; García-Campayo, Javier

2015-01-01

PURPOSE Positive effects have been reported after mindfulness-based interventions (MBIs) in diverse clinical and nonclinical populations. Primary care is a key health care setting for addressing common chronic conditions, and an effective MBI designed for this setting could benefit countless people worldwide. Meta-analyses of MBIs have become popular, but little is known about their efficacy in primary care. Our aim was to investigate the application and efficacy of MBIs that address primary care patients. METHODS We performed a meta-analytic review of randomized controlled trials addressing the effect of MBIs in adult patients recruited from primary care settings. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and Cochrane guidelines were followed. Effect sizes were calculated with the Hedges g in random effects models. RESULTS The meta-analyses were based on 6 trials having a total of 553 patients. The overall effect size of MBI compared with a control condition for improving general health was moderate (g = 0.48; P = .002), with moderate heterogeneity (I2 = 59; P <.05). We found no indication of publication bias in the overall estimates. MBIs were efficacious for improving mental health (g = 0.56; P = .007), with a high heterogeneity (I2 = 78; P <.01), and for improving quality of life (g = 0.29; P = .002), with a low heterogeneity (I2 = 0; P >.05). CONCLUSIONS Although the number of randomized controlled trials applying MBIs in primary care is still limited, our results suggest that these interventions are promising for the mental health and quality of life of primary care patients. We discuss innovative approaches for implementing MBIs, such as complex intervention and stepped care. PMID:26553897

Association of self-efficacy of parents/caregivers with childhood asthma control parameters.

PubMed

Gomes, Ana Lúcia Araújo; Lima, Kamila Ferreira; Mendes, Elizamar Regina da Rocha; Joventino, Emanuella Silva; Martins, Mariana Cavalcante; Almeida, Paulo César de; Ximenes, Lorena Barbosa

2017-01-01

Objective To verify the association between the self-efficacy of parents/caregivers and control parameters of childhood asthma. Method Cross-sectional study with parents/caregivers of asthmatic children. Data were collected through a sociodemographic questionnaire and the Self-efficacy and their child's level of asthma control scale: Brazilian version. Results Participation of 216 parents/caregivers in the study. There was a statistically significant association between self-efficacy scores and the following variables: unscheduled physician visit (p=0.001), visit to emergency department (p<0.001), hospital stays in the previous 12 months (p=0.005), physical activity limitation (p=0.003), school days missed (p<0.001), impaired sleep (p<0.001), ability to differentiate crisis medication from control medication (p=0.024), use of spacer (p=0.001), performing oral hygiene after use of inhaled corticosteroids (p=0.003), and knowledge of medication gratuity (p=0.004). Conclusion A significant relationship of the self-efficacy of parents/caregivers of asthmatic children with control parameters and training on the necessary skills to reach this control was demonstrated in the study.

Use of Heart Rate Variability and Photoplethysmograph-Derived Parameters as Assessment Signals of Radiofrequency Therapy Efficacy for Chronic Pain.

PubMed

Ye, Jing-Jhao; Chuang, Chiung-Cheng; Tai, Yu-Ting; Lee, Kuan-Ting; Hung, Kuo-Sheng

2017-09-01

Radiofrequency therapy (RFT) generates molecular motion and produces heat and electromagnetic effects on tissues, which attenuate pain sensation and thereby relieve pain. This study was to observe the altering trend of physiological parameters after RFT for chronic cervical or lumbar pain. This study recruited 66 patients with chronic cervical or lumbar pain and recorded their physiological parameters before and after RFT using heart rate variability (HRV) and photoplethysmography (PPG) to explore the feasibility of RFT efficacy assessment. The patients' visual analog scale scores significantly decreased after RFT and the HRV parameters that represented parasympathetic activity significantly changed (HR decreased, and R-R interval and low- and high-frequency power increased significantly). Meanwhile, the PPG parameters that represented sympathetic activity also increased (PPG amplitude and autonomic nervous system state significantly decreased). This study showed significant efficacy of RFT in patients with chronic cervical or lumbar pain. The changes of HRV and PPG parameters may explain part of the mechanisms of RFT. © 2016 World Institute of Pain.

A randomized, multinational, noninferiority, phase III trial to evaluate the safety and efficacy of BF-200 aminolaevulinic acid gel vs. methyl aminolaevulinate cream in the treatment of nonaggressive basal cell carcinoma with photodynamic therapy.

PubMed

Morton, C A; Dominicus, R; Radny, P; Dirschka, T; Hauschild, A; Reinhold, U; Aschoff, R; Ulrich, M; Keohane, S; Ekanayake-Bohlig, S; Ibbotson, S; Ostendorf, R; Berking, C; Gröne, D; Schulze, H J; Ockenfels, H M; Jasnoch, V; Kurzen, H; Sebastian, M; Stege, H; Staubach, P; Gupta, G; Hübinger, F; Ziabreva, I; Schmitz, B; Gertzmann, A; Lübbert, H; Szeimies, R-M

2018-02-12

Basal cell carcinoma (BCC) represents the most common nonmelanoma skin cancer worldwide, affecting mainly adult, fair-skinned individuals. The World Health Organization distinguishes aggressive and nonaggressive forms, of which prototypical variants of the latter are primary nodular and superficial BCC. To demonstrate noninferiority of BF-200 ALA (a nanoemulsion gel containing 5-aminolaevulinic acid) compared with MAL (a cream containing methyl aminolaevulinate) in the treatment of nonaggressive BCC with photodynamic therapy (PDT). Noninferiority of the primary efficacy variable (overall patient complete response 12 weeks after last PDT) would be declared if the mean response for BF-200 ALA was no worse than that for MAL, within a statistical margin of Δ = -15%. The study was a randomized, phase III trial performed in Germany and the U.K. with ongoing 5-year follow-up. Of 281 randomized patients, 138 were treated with BF-200 ALA and 143 with MAL. Patients received two PDT sessions 1 week apart. Remaining lesions 12 weeks after the second PDT were retreated. Illumination was performed with a red light source (635 nm, 37 J cm -2 ). The results shown include clinical end points and patients' reassessment 12 months after the last PDT. The study was registered with EudraCT (number 2013-003241-42). Of the BF-200 ALA-treated patients, 93·4% were complete responders compared with 91·8% in the MAL group. The difference of means was 1·6, with a one-sided 97·5% confidence interval of -6·5, establishing noninferiority (P < 0·0001). The results for secondary efficacy parameters were in line with the primary outcome. Recurrence rates 12 months after the last treatment were ≤ 10%. Treatment of nonaggressive BCC with BF-200 ALA-PDT is highly effective and well tolerated with proven noninferiority to MAL-PDT. It demonstrates low recurrence rates after 1 year of follow-up. © 2018 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.

Efficacy and Safety of Dual Antiplatelet Therapy After Complex PCI.

PubMed

Giustino, Gennaro; Chieffo, Alaide; Palmerini, Tullio; Valgimigli, Marco; Feres, Fausto; Abizaid, Alexandre; Costa, Ricardo A; Hong, Myeong-Ki; Kim, Byeong-Keuk; Jang, Yangsoo; Kim, Hyo-Soo; Park, Kyung Woo; Gilard, Martine; Morice, Marie-Claude; Sawaya, Fadi; Sardella, Gennaro; Genereux, Philippe; Redfors, Bjorn; Leon, Martin B; Bhatt, Deepak L; Stone, Gregg W; Colombo, Antonio

2016-10-25

Optimal upfront dual antiplatelet therapy (DAPT) duration after complex percutaneous coronary intervention (PCI) with drug-eluting stents (DES) remains unclear. This study investigated the efficacy and safety of long-term (≥12 months) versus short-term (3 or 6 months) DAPT with aspirin and clopidogrel according to PCI complexity. The authors pooled patient-level data from 6 randomized controlled trials investigating DAPT durations after PCI. Complex PCI was defined as having at least 1 of the following features: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, or chronic total occlusion. The primary efficacy endpoint was major adverse cardiac events (MACE), defined as the composite of cardiac death, myocardial infarction, or stent thrombosis. The primary safety endpoint was major bleeding. Intention-to-treat was the primary analytic approach. Of 9,577 patients included in the pooled dataset for whom procedural variables were available, 1,680 (17.5%) underwent complex PCI. Overall, 85% of patients received new-generation DES. At a median follow-up time of 392 days (interquartile range: 366 to 710 days), patients who underwent complex PCI had a higher risk of MACE (adjusted hazard ratio [HR]: 1.98; 95% confidence interval [CI]: 1.50 to 2.60; p < 0.0001). Compared with short-term DAPT, long-term DAPT yielded significant reductions in MACE in the complex PCI group (adjusted HR: 0.56; 95% CI: 0.35 to 0.89) versus the noncomplex PCI group (adjusted HR: 1.01; 95% CI: 0.75 to 1.35; p interaction  = 0.01). The magnitude of the benefit with long-term DAPT was progressively greater per increase in procedural complexity. Long-term DAPT was associated with increased risk for major bleeding, which was similar between groups (p interaction  = 0.96). Results were consistent by per-treatment landmark analysis. Alongside other established clinical risk factors, procedural complexity is an important parameter to take into account in tailoring upfront duration of DAPT. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Impact of power index, hydroureteronephrosis, stone size, and composition on the efficacy of in situ boosted ESWL for primary proximal ureteral calculi.

PubMed

Singh, I; Gupta, N P; Hemal, A K; Dogra, P N; Ansari, M S; Seth, A; Aron, M

2001-07-01

The efficacy, safety, feasibility, and outcome of in situ treatment applied to select proximal ureteral calculi was assessed and analyzed with a view to avoiding auxiliary interventions and providing high clearance rates in the shortest possible time. We studied the impact of several clinically important variables, including power index, degree of hydroureteronephrosis (HDUN), stone size, and composition on the efficacy of sequential in situ boosted extracorporeal shock wave lithotripsy (ESWL) in a select group. The power index requirement for the in situ boosted protocol and the impact of the stone size/composition, degree of HDUN, and clearance rates were also analyzed. An in situ (no instrumentation) boosted protocol was applied to 130 primary unimpacted proximal ureteral calculi with no prior intervention. A typical session with the Siemens Lithostar Plus comprised 3000 shock waves, in installments of 500, deployed at a power setting of 1 to 4 kV with a gradual stepwise escalation. Sequential boosted additional sessions of ESWL were administered on days 2, 7, and 14, tailored to the degree of fragmentation, clearance status, and amount of residual stone bulk. Several parameters (shock waves, kilovolts used, fluoroscopy time, number of sessions, stone size, composition, fragmentation, clearance, and HDUN) were recorded and the results analyzed statistically. The results were excellent in 83.8%, with a mean duration to complete clearance of 11.3 days. In situ ESWL failed in 7.69%, and the auxiliary intervention rate was 10.7%. Pre-ESWL HDUN was present in 78.3%, the mean power index was 184.6/session/case, and the average stone burden was 8.9 mm(2). Calcium oxalate monohydrate was the most common stone (56%). Renal colic was the most common side effect observed. The power index, fragmentation at the first session, and stone size were found to be the most favorable significant variables affecting stone clearance. The degree of HDUN, number of sessions, and stone composition did not significantly impact the clearance rates. In situ boosted ESWL should be the first-line therapeutic modality in select unimpacted primary proximal ureteral stones.

Exploring Australian Pre-Service Teachers Sense of Efficacy, Its Sources, and Some Possible Influences

ERIC Educational Resources Information Center

O'Neill, Sue; Stephenson, Jennifer

2012-01-01

Beginning teachers that possess a good sense of efficacy are less likely to suffer stress, burnout, or attrition. This study reports final-year Australian pre-service primary teachers sense of efficacy scores and the sources of information that contributed to it. Results showed that our beginning teachers had a good sense of efficacy, and…

Measuring Efficacy Sources: Development and Validation of the Sources of Teacher Efficacy Questionnaire (STEQ) for Chinese Teachers

ERIC Educational Resources Information Center

Hoi, Cathy Ka Weng; Zhou, Mingming; Teo, Timothy; Nie, Youyan

2017-01-01

The aim of the current study is to develop and validate an instrument to measure the four sources of teacher efficacy among Chinese primary school teachers. A 26-item Sources of Teacher Efficacy Questionnaire (STEQ) was proposed with four subscales: mastery experience, vicarious experience, social persuasion, and physiological arousal. The results…

Perceived efficacy of herbal remedies by users accessing primary healthcare in Trinidad

PubMed Central

Clement, Yuri N; Morton-Gittens, Jamie; Basdeo, Luke; Blades, Alexander; Francis, Marie-Joanna; Gomes, Natalie; Janjua, Meer; Singh, Adelle

2007-01-01

Background The increasing global popularity of herbal remedies requires further investigation to determine the probable factors driving this burgeoning phenomenon. We propose that the users' perception of efficacy is an important factor and assessed the perceived efficacy of herbal remedies by users accessing primary health facilities throughout Trinidad. Additionally, we determined how these users rated herbal remedies compared to conventional allopathic medicines as being less, equally or more efficacious. Methods A descriptive cross-sectional study was undertaken at 16 randomly selected primary healthcare facilities throughout Trinidad during June-August 2005. A de novo, pilot-tested questionnaire was interviewer-administered to confirmed herbal users (previous or current). Stepwise multiple regression analysis was done to determine the influence of predictor variables on perceived efficacy and comparative efficacy with conventional medicines. Results 265 herbal users entered the study and cited over 100 herbs for the promotion of health/wellness and the management of specific health concerns. Garlic was the most popular herb (in 48.3% of the sample) and was used for the common cold, cough, fever, as 'blood cleansers' and carminatives. It was also used in 20% of hypertension patients. 230 users (86.8%) indicated that herbs were efficacious and perceived that they had equal or greater efficacy than conventional allopathic medicines. Gender, ethnicity, income and years of formal education did not influence patients' perception of herb efficacy; however, age did (p = 0.036). Concomitant use of herbs and allopathic medicines was relatively high at 30%; and most users did not inform their attending physician. Conclusion Most users perceived that herbs were efficacious, and in some instances, more efficacious than conventional medicines. We suggest that this perception may be a major contributing factor influencing the sustained and increasing popularity of herbs. Evidence-based research in the form of randomized controlled clinical trials should direct the proper use of herbs to validate (or otherwise) efficacy and determine safety. In the Caribbean, most indigenous herbs are not well investigated and this points to the urgent need for biomedical investigations to assess the safety profile and efficacy of our popular medicinal herbs. PMID:17286858

Evaluation of the efficacy of rotary vs. hand files in root canal preparation of primary teeth in vitro using CBCT.

PubMed

Musale, P K; Mujawar, S A V

2014-04-01

This in vitro study aimed to evaluate the efficacy of rotary ProFile, ProTaper, Hero Shaper and K-files in shaping ability, cleaning efficacy, preparation time and instrument distortion in primary molars. Sixty extracted primary mandibular second molars were divided into four equal groups: Group I K-file, Group II ProFile, Group III ProTaper file and Group IV Hero Shaper file. The shaping ability was determined by comparing pre- and post-instrumentation CBCT scans and data analysed with SPSS program using the Chi-square test. Cleaning efficacy was evaluated by the degree of India ink removal from the canal walls under stereomicroscopy. Instrumentation times were calculated for each tooth and instrument distortion was visually checked and duly noted. The cleaning efficacy and instrumentation time were determined using ANOVA with Tukey's correction. Instrument distortion was analysed using Chi-square test. The canal taper was significantly more conical for rotary files as compared to K-files with Chi-square test (p < 0.05). Cleaning efficacy of rotary files with average scores (Groups II- 0.68, III- 0.48 and IV- 0.58) was significantly better than K-files (Group I- 0.93) (p < 0.05). Mean instrumentation time with K-file (20.7 min) was significantly higher than rotary files (Groups II 8.9, III 5.6, and IV 8.1 min) (p < 0.05). Instrument distortion was observed in Group I (4.3%), while none of the rotary files were distorted. Rotary files prepared more conical canals in primary teeth than manual instruments. Reduced preparation time with rotary files enhances patient cooperation especially in young children.

Determining tumor blood flow parameters from dynamic image measurements

NASA Astrophysics Data System (ADS)

Libertini, Jessica M.

2008-11-01

Many recent cancer treatments focus on preventing angiogenesis, the process by which a tumor promotes the growth of large and efficient capillary beds for the increased nourishment required to support the tumor's rapid growth[l]. To measure the efficacy of these treatments in a timely fashion, there is an interest in using data from dynamic sequences of contrast-enhanced medical imaging, such as MRI and CT, to measure blood flow parameters such as perfusion, permeability-surface-area product, and the relative volumes of the plasma and extracellular-extravascular space. Starting with a two compartment model presented by the radiology community[2], this work challenges the application of a simplification to this problem, which was originally developed to model capillary reuptake[3]. While the primary result of this work is the demonstration of the inaccuracy of this simplification, the remainder of the paper is dedicated to presenting alternative methods for calculating the perfusion and plasma volume coefficients. These methods are applied to model data sets based on real patient data, and preliminary results are presented.

Efficacy and safety of manual acupuncture manipulations with different frequencies on epigastric pain syndrome (EPS) in functional dyspepsia (FD) patients: study protocol for a randomized controlled trial.

PubMed

Hong, Shou-Hai; Ding, Sha-Sha; Wu, Fei; Bi, Ying; Xu, Fu; Wan, Yi-Jia; Xuan, Li-Hua

2017-03-06

Manual acupuncture (MA) manipulations are one of the key factors influencing acupuncture effects in traditional Chinese medicine theory. Different MA manipulations contain different stimulating parameters, thus generating different acupuncture responses or effects. Evidence has demonstrated that acupuncture is effective for functional dyspepsia (FD). However, the effects of different stimulating parameters of MA manipulations on FD remain unclear. This study is a randomized controlled trial with a four-arm, parallel-group structure. Patients with FD with epigastric pain syndrome (EPS) will be included and randomly allocated into four groups: three MA manipulation groups (separately treated with a frequency of 1 Hz, 2 Hz, or 3 Hz) and a control group. All groups will receive omeprazole as a basic treatment and acupuncture: in the MA manipulation groups, the needles will be manipulated manually with three different frequencies on the basis when de qi is reached, while in the control group, the needles will be inserted without any manipulation. All patients will receive acupuncture treatment of five consecutive sessions per week for 2 weeks and be followed up at 4, 8, and 12 weeks. The primary outcomes of the study include patients' response to the treatment. The secondary outcomes include dyspeptic symptoms, quality of life, mental status, fasting serum gastrin, motilin, and ghrelin concentrations, and adverse events. The protocol was approved by the Ethics committee of the First Affiliated Hospital of Zhejiang Chinese Medical University (2016-K-057-01). The aim of this study is to evaluate the efficacy and safety of MA manipulations with different stimulating parameters (different frequencies) on EPS in patients with FD. Chinese Clinical Trial Registry, ChiCTR-IOR-16008189 . Registered on 30 March 2016.

Science teaching self-efficacy in a primary school: A case study

NASA Astrophysics Data System (ADS)

de Laat, Jenny; Watters, James J.

1995-12-01

Bandura's theory of self-efficacy predicts that teachers with high, self-efficacy should persist longer, provide a greater academic focus in child-centred classrooms and exhibit different types of feedback than teachers who have lower self-efficacy. This paper reports on the science teaching self-efficacy in a group of teachers at a state primary school. The research was conducted in two stages using firstly the Science Teaching Efficacy Beliefs Instrument (STEBI-A) to identify cases, and secondly, a semistructured interview coupled with classroom observations. Thirty seven teaching staff were surveyed with the STEBI-A instrument. The five highest and five lowest scoring teachers on the personal science teaching self-efficacy subscale of the STEBI-A were interviewed. The analysis of interviews and observations indicated that teachers with high personal science teaching self-efficacy have had a long interest in science and a relatively strong background of formal science studies with opportunities for exploring out of school activities. Although they may have experienced negative science experiences in their own schooling other ameliorating factors existed which maintained their interest. Their instructional strategies in science lessons were more child-centred than those reported by teachers with lower personal science teaching self-efficacy. The implications of the results for the inservice training of teachers are discussed.

[Efficacy and safety of initial treatment with glimpeiride versus sitagliptin in type 2 diabetes].

PubMed

Tamez-Pérez, Héctor Eloy

2015-01-01

Diabetes mellitus type 2 (DM2) is a multifactorial disease that can be treated with oral antiglycemic medication or with insulin. The antiglycemic drugs glimepiride and sitagliptin have different mechanisms of action, and have not been directly compared in a Latin-American population with recent DM2 diagnostic. The primary objective in this randomized (1:1), multicentric, two arms, open study with adult patients, was to compare the efficacy of glimepiride with sitagliptin in a DM2 population naïve to treatment. Secondary objectives had been the effect on fasting and postprandial glycemia, hypoglycemia, weight modification, safety, percentage of patients quiting the trial, vital signs and laboratory results. Glimepiride and sitagliptin were equally effective in glycemic control and all other parameters, and the only difference found has been the frequency of hypoglycemic events reports, wich has been reported as higher and statistically significant in the in the glimepiride group. No fatalities where reported in either group. Glimepiride or sitagliptin monotherapy are equally effective in control of HbA1c.

Management of pediatric mandibular fractures using bioresorbable plating system – Efficacy, stability, and clinical outcomes: Our experiences and literature review

PubMed Central

Singh, Mahinder; Singh, R.K.; Passi, Deepak; Aggarwal, Mohit; Kaur, Guneet

2015-01-01

Aims The purpose of this study was to determine the efficacy and stability of the biodegradable fixation system for treatment of mandible fractures in pediatric patients by measuring the bite force. Methods Sixty pediatric patients with mandibular fractures (36 males, 24 females) were included in this study. The 2.5-mm resorbable plates were adapted along Champy's line of ideal osteosynthesis and secured with four 2.5 mm diameter monocortical resorbable screws, 8 mm in length. All patients were followed for 10 months. Clinical parameters, such as soft tissue infection, nonunion, malunion, implant exposure, malocclusion, nerve injury, and bite force for stability, were prospectively assessed. Results Adequate fixation and primary bone healing was achieved in 100% of the cases. Six minor complications (10%) were observed: 2 soft tissue infections (3%), 1 plate dehiscence (2%), 1 malocclusion (2%), and 2 paresthesia (3%). Conclusion 2.5-mm resorbable plating system along Champy's line of ideal osteosynthesis is a good treatment modality for mandible fractures in pediatric patients. PMID:27195206

The Treatment Advocacy Program: A Randomized Controlled Trial of a Peer-Led Safer Sex Intervention for HIV-Infected Men Who Have Sex with Men

ERIC Educational Resources Information Center

McKirnan, David J.; Tolou-Shams, Marina; Courtenay-Quirk, Cari

2010-01-01

Objective: Primary care may be an effective venue for delivering behavioral interventions for sexual safety among HIV-positive men who have sex with men (MSM); however, few studies show efficacy for such an approach. We tested the efficacy of the Treatment Advocacy Program (TAP), a 4-session, primary-care-based, individual counseling intervention…

Correlates of caregiver burden among family caregivers of older Korean Americans.

PubMed

Casado, Banghwa; Sacco, Paul

2012-05-01

Despite the rapid growth of older ethnic minority populations, knowledge is limited about informal caregiving among these groups. Our aim was to identify correlates of caregiver burden among family caregivers of older Korean Americans (KAs). A cross-sectional survey collected data from 146 KA caregivers. Using a modified stress-appraisal model, we examined background and context characteristics (caregiver sex, relationship to care recipient, college education, English proficiency, time in caregiving role, family support network, friend support network), a primary stressor (care recipient functional dependency), a primary appraisal (caregiving hours), and resources (family agreement, care management self-efficacy, service use self-efficacy) as potential correlates of caregiver burden. Interactions between the primary stressor, primary appraisal, and resources were also tested. Being female and the care recipient's spouse were associated with higher burden. Conversely, a larger family support network, greater family agreement, and greater care management self-efficacy were associated with lower burden. A significant interaction was detected between functional dependency and family agreement; higher levels of family agreement moderated the association between care recipient functional dependency and caregiver burden. Interventions to reduce caregiver burden in KA caregivers may be more effective if they include approaches specifically designed to build family support, improve family agreement, and increase caregivers' self-efficacy.

Contraceptive efficacy and safety of estradiol valerate/dienogest in a healthy female population: a multicenter, open-label, uncontrolled Phase III study.

PubMed

Yu, Qi; Huang, Zirong; Ren, Mulan; Chang, Qing; Zhang, Zhongqi; Parke, Susanne

2018-01-01

To investigate the efficacy and safety of a combined oral contraceptive containing estradiol valerate and dienogest (EV/DNG) in healthy Asian women. In this multicenter Phase III study, women received oral EV/DNG in a 28-day regimen for 13 cycles. The primary efficacy endpoint was the number of unintended pregnancies, measured by the Pearl Index (PI); secondary efficacy endpoints included bleeding pattern and cycle control parameters. Adverse events were monitored during the study and overall satisfaction with treatment was determined on completion of the study. A total of 954 Asian women (97.7% of subjects assigned to study medication; mean age 33.4 years) were treated. Five pregnancies were reported during EV/DNG treatment over 796.34 relevant woman-years of exposure, giving an unadjusted PI of 0.63 and a cumulative failure rate of 0.0049; 3 pregnancies during EV/DNG treatment over 760.35 relevant woman-years of exposure gave an adjusted PI of 0.39. The bleeding pattern improved during the reporting periods within the study. The proportion of women who experienced withdrawal bleeding decreased with treatment (84.9% of women during Cycle 1 vs 79.3% in Cycle 13), and the mean length of withdrawal bleeding decreased with treatment (4.2 vs 3.4 days). The number and maximum length of intracyclic bleeding/spotting episodes also decreased with EV/DNG. EV/DNG was well tolerated, and 92% of women included in the study were very satisfied or somewhat satisfied with EV/DNG. EV/DNG showed high contraceptive efficacy, was well tolerated in Asian women, and may be effectively used in this population. ClinicalTrials.gov identifier: NCT01638910.

An evaluation of 10 percent and 20 percent benzocaine gels in patients with acute toothaches: efficacy, tolerability and compliance with label dose administration directions.

PubMed

Hersh, Elliot V; Ciancio, Sebastian G; Kuperstein, Arthur S; Stoopler, Eric T; Moore, Paul A; Boynes, Sean G; Levine, Steven C; Casamassimo, Paul; Leyva, Rina; Mathew, Tanya; Shibly, Othman; Creighton, Paul; Jeffers, Gary E; Corby, Patricia M A; Turetzky, Stanley N; Papas, Athena; Wallen, Jillian; Idzik-Starr, Cynthia; Gordon, Sharon M

2013-05-01

The authors evaluated the efficacy and tolerability of 10 percent and 20 percent benzocaine gels compared with those of a vehicle (placebo) gel for the temporary relief of toothache pain. They also assessed the compliance with the label dose administration directions on the part of participants with toothache pain. Under double-masked conditions, 576 participants self-applied study gel to an open tooth cavity and surrounding oral tissues. Participants evaluated their pain intensity and pain relief for 120 minutes. The authors determined the amount of gel the participants applied. The responders' rates (the primary efficacy parameter), defined as the percentage of participants who had an improvement in pain intensity as exhibited by a pain score reduction of at least one unit on the dental pain scale from baseline for two consecutive assessments any time between the five- and 20-minute points, were 87.3 percent, 80.7 percent and 70.4 percent, respectively, for 20 percent benzocaine gel, 10 percent benzocaine gel and vehicle gel. Both benzocaine gels were significantly (P ≤ .05) better than vehicle gel; the 20 percent benzocaine gel also was significantly (P ≤ .05) better than the 10 percent benzocaine gel. The mean amount of gel applied was 235.6 milligrams, with 88.2 percent of participants applying 400 mg or less. Both 10 percent and 20 percent benzocaine gels were more efficacious than the vehicle gel, and the 20 percent benzocaine gel was more efficacious than the 10 percent benzocaine gel. All treatments were well tolerated by participants. Practical Implications. Patients can use 10 percent and 20 percent benzocaine gels to temporarily treat toothache pain safely.

Critical reappraisal of embryo quality as a predictive parameter for pregnancy outcome: a pilot study

PubMed Central

Campo, R.; Binda, M.M.; Van Kerkhoven, G.; Frederickx, V.; Serneels, A.; Roziers, P.; Lopes, A.S.; Gordts, S.; Puttemans, P.; Gordts, S.

2010-01-01

Aim of the study: Pilot study to analyse the efficacy and embryo morphology using a new human embryo culture medium (GM501) versus the conventional used medium (ISM1). Methods: Over a four-month period, all patients at the Leuven Institute of Fertility and Embryology (LIFE) were randomly allocated to have their embryos cultured in either the standard sequential culture medium ISM1 (control) or in a new universal medium (GM501) (study group). Primary outcome parameters were clinical pregnancy and live birth rate. The secondary outcome parameter was the correlation of embryo fragmentation rate with pregnancy outcome. Results: We did not observe any differences between the ISM1 control group and GM501 study group with regard to fertilization, pregnancy, implantation rates, ongoing pregnancy, and babies born. The number of embryos with a minimal fragmentation rate (less than 30%) was significantly higher in the GM501 study group. Conclusion: Although a significant higher embryo fragmentation rate was seen in In vitro culture of embryos in GM501, pregnancy outcome results were comparable to those of embryos cultured in ISM1. According to our results the value of embryo morphological criteria as a parameter for pregnancy outcome should be examined and discussed again. PMID:25009716

Gender differences in determinants of condom use among HIV clients in Uganda.

PubMed

Walusaga, Happy Annet; Kyohangirwe, Rossette; Wagner, Glenn J

2012-11-01

Little research has examined gender differences in reporting of condom use, which is the goal of our analysis. A baseline study was conducted in two urban clinics and we examined data from sexually active clients entering HIV care who enrolled in a prospective longitudinal cohort study. The primary outcome was consistent condom use and determinant variables were demographics, physical health and immune status, economic well-being, relationship characteristics, psychosocial functioning, and self-efficacy. Of 280 participants, 129 were males and 151 females, and 41.7% had at least some secondary education; 60.7% did not always use condoms. Nearly half (48.1%) of men reported always using condoms compared to 31.8% of females. In bivariate analyses, men who consistently use condoms were more likely to be working, have a primary partner who was HIV negative, to have disclosed their HIV status to their primary partner, and to have higher general self-efficacy and condom use self-efficacy compared to men who did not always use condoms. Higher general self-efficacy and condom use self-efficacy were the only variables associated with reported consistent condom use among women. In regression analysis, working in the last 7 days, general self efficacy, and condom use self-efficacy were associated with consistent condom use among men. These findings reveal low rates of consistent condom use among people living with HIV, and a gender difference with men more likely to report consistent condom use. These data suggest the need for gender sensitive prevention programs and strategies, including programs that can provide women with greater control and self-efficacy regarding use of protective methods.

Efficacy and Safety of Lacosamide in Painful Diabetic Neuropathy

PubMed Central

Ziegler, Dan; Hidvégi, Tibor; Gurieva, Irina; Bongardt, Sabine; Freynhagen, Rainer; Sen, David; Sommerville, Kenneth

2010-01-01

OBJECTIVE To evaluate efficacy and safety of lacosamide compared with placebo in painful diabetic polyneuropathy. RESEARCH DESIGN AND METHODS Diabetic patients with at least moderate neuropathic pain were randomized to placebo or lacosamide 400 (in a slow or standard titration) or 600 mg/day over 6-week titration and 12-week maintenance periods. Primary efficacy criterion was intra-individual change in average daily Numeric Pain Rating Scale score from baseline to the last 4 weeks. RESULTS For the primary end point, pain reduction was numerically but not statistically greater with lacosamide compared with placebo (400 mg/day, P = 0.12; 600 mg/day, P = 0.18). Both doses were significantly more effective compared with placebo over the titration (P = 0.03, P = 0.006), maintenance (P = 0.01, P = 0.005), and entire treatment periods (P = 0.03, P = 0.02). Safety profiles between titration schemes were similar. CONCLUSIONS Lacosamide reduced neuropathic pain and was well tolerated in diabetic patients, but the primary efficacy criterion was not met, possibly due to an increased placebo response over the last 4 weeks. PMID:20067958

Sources of Self-Efficacy: Four Professional Development Formats and Their Relationship to Self-Efficacy and Implementation of a New Teaching Strategy

ERIC Educational Resources Information Center

Tschannen-Moran, Megan; McMaster, Peggy

2009-01-01

This quasi-experimental study tested the potency of different sources of self-efficacy beliefs. Respondents were primary teachers (N = 93) in 9 schools who completed surveys of their self-efficacy beliefs and level of implementation of a new teaching strategy for beginning readers before and after participating in 1 of 4 formats of professional…

Efficacy and safety of a biodegradable polymer sirolimus-eluting stent in primary percutaneous coronary intervention: a randomized controlled trial

PubMed Central

Li, Qiang; Tong, Zichuan; Wang, Lefeng; Zhang, Jianjun; Ge, Yonggui; Wang, Hongshi; Li, Weiming; Xu, Li; Ni, Zhuhua

2013-01-01

Introduction With long-term follow-up, whether biodegradable polymer drug-eluting stents (DES) is efficient and safe in primary percutaneous coronary intervention (PCI) remains a controversial issue. This study aims to assess the long-term efficacy and safety of DES in PCI for ST-segment elevation myocardial infarction (STEMI). Material and methods A prospective, randomized single-blind study with 3-year follow-up was performed to compare biodegradable polymer DES with durable polymer DES in 332 STEMI patients treated with primary PCI. The primary end point was major adverse cardiac events (MACE) at 3 years after the procedure, defined as the composite of cardiac death, recurrent infarction, and target vessel revascularization. The secondary end points included in-segment late luminal loss (LLL) and binary restenosis at 9 months and cumulative stent thrombosis (ST) event rates up to 3 years. Results The rate of the primary end points and the secondary end points including major adverse cardiac events, in-segment late luminal loss, binary restenosis, and cumulative thrombotic event rates were comparable between biodegradable polymer DES and durable polymer DES in these 332 STEMI patients treated with primary PCI at 3 years. Conclusions Biodegradable polymer DES has similar efficacy and safety profiles at 3 years compared with durable polymer DES in STEMI patients treated with primary PCI. PMID:24482648

Efficacy of Ginger for Alleviating the Symptoms of Primary Dysmenorrhea: A Systematic Review and Meta-analysis of Randomized Clinical Trials.

PubMed

Daily, James W; Zhang, Xin; Kim, Da Sol; Park, Sunmin

2015-12-01

There has been no attempt to date to synthesize the available evidence for the efficacy of ginger for treating primary dysmenorrhea. This systematic review evaluates the current evidence for the effectiveness of ginger for treating primary dysmenorrhea. Literature searches were conducted using 12 electronic databases including PubMed, EMBASE, Cochrane Library, Korean databases, Chinese medical databases, and Indian scientific database. Search terms used were: "ginger" or "Zingiber officinale" and "dysmenorrhea" and "pain." Studies using ginger as a treatment of primary dysmenorrhea were considered for inclusion. The major outcome of primary dysmenorrhea was assessed using a pain visual analogue score (PVAS). Initial searches yielded 29 articles. Of these original results, seven met specific selection criteria. Four of the RCTs compared the therapeutic efficacy of ginger with a placebo during the first 3-4 days of the menstrual cycle and were included in the meta analysis. The meta-analysis of these data showed a significant effect of ginger in reducing PVAS in subjects having primary dysmenorrhea (risk ratio, -1.85; 95% CI of -2.87, -0.84, P = 0.0003). Six RCTs out of 7 exhibited low to moderate of risk of bias. Collectively these RCTs provide suggestive evidence for the effectiveness of 750-2000 mg ginger powder during the first 3-4 days of menstrual cycle for primary dysmenorrhea. Wiley Periodicals, Inc.

Benign Headache Management in the Emergency Department.

PubMed

Long, Brit J; Koyfman, Alex

2018-04-01

Headache is a common complaint managed in the emergency department (ED), with emergency physicians focusing on evaluation for life-threatening conditions while treating pain and nausea. This review evaluates the treatment of benign, primary headaches in the ED, with recommendations provided based on the literature. Headaches are a major cause of disability in the United States and a common condition managed in the ED. The primary objectives of emergency evaluation of these patients include evaluation for a life-threatening, secondary cause of headache, with treatment of primary headaches. Close evaluation for a secondary cause of headache include consideration of red flags and focused neurologic examination. The diagnosis of primary headaches is clinical. Literature has evaluated medication efficacy in headache treatment, with antidopaminergic medications demonstrating high rates of efficacy when used in combination with nonsteroidal inflammatory drugs or acetaminophen. Dexamethasone can be used for the reduction of headache recurrence. If dehydration is present, intravenous fluids should be provided. Diphenhydramine is not recommended for analgesia but may reduce akathisia associated with prochlorperazine. Ketamine, propofol, and nerve blocks demonstrate promise. Triptan agents are also efficacious, provided absence of contraindications. Most patients are appropriate for discharge with pain improvement. A variety of medications is available for the treatment of primary headaches in the ED. Antidopaminergic agents demonstrate the highest efficacy and should be provided with acetaminophen and nonsteroidal inflammatory drugs. Dexamethasone may reduce headache recurrence. Other treatments include ketamine, propofol, and nerve blocks. Published by Elsevier Inc.

Apatinib, a novel tyrosine kinase inhibitor, suppresses tumor growth in cervical cancer and synergizes with Paclitaxel.

PubMed

Qiu, Haifeng; Li, Jing; Liu, Qiuli; Tang, Mei; Wang, Yuan

2018-06-09

Apatinib is a novel tyrosine kinase inhibitor that targets VEGFR2 signal and exhibits potent anti-tumor effects in human cancers. In this study, we aim to investigate the efficacy of Apatinib in cervical cancer. The protein expression of VEGFR2 and its relationships with clinical parameters were investigated in a panel of cervical cancer patients. In vitro, a series of experiments were performed to detect the effects of Apatinib on the proliferation, apoptosis and cell cycle in cervical cancer cells. Both the immortalized cell lines and primary cultured tissues were used to investigate the synergy between Apatinib and chemotherapeutic drugs. The in vivo effects of Apatinib were validated in a nude mouse model. Compared to that in normal cervix, VEGFR2 protein was significantly upregulated in cervical cancer tissues (P<0.001); this was positively correlated with advanced tumor stage, lymph node metastasis, and a poor prognosis. In vitro, Apatinib markedly induced apoptosis and G1-phase arrest, suppressed cell growth, and decreased colony formation ability. We also found that primary cancer tissues with higher level of VEGFR2 were much more sensitive to Apatinib. Further, we proved that Apatinib significantly increased the sensitivity to Paclitaxel in cervical cancer cells and the mouse model. Collectively, we firstly report the anti-tumor efficacy of Apatinib in cervical cancer. Moreover, Apatinib synergized with Paclitaxel to achieve more significant suppression on tumor growth, proposing that Apatinib might be a potent drug for cervical cancer.

The novel calicheamicin-conjugated CD22 antibody inotuzumab ozogamicin (CMC-544) effectively kills primary pediatric acute lymphoblastic leukemia cells.

PubMed

de Vries, J F; Zwaan, C M; De Bie, M; Voerman, J S A; den Boer, M L; van Dongen, J J M; van der Velden, V H J

2012-02-01

We investigated whether the newly developed antibody (Ab) -targeted therapy inotuzumab ozogamicin (CMC-544), consisting of a humanized CD22 Ab linked to calicheamicin, is effective in pediatric primary B-cell precursor acute lymphoblastic leukemia (BCP-ALL) cells in vitro, and analyzed which parameters determine its efficacy. CMC-544 induced dose-dependent cell kill in the majority of BCP-ALL cells, although IC(50) values varied substantially (median 4.8 ng/ml, range 0.1-1000 ng/ml at 48 h). The efficacy of CMC-544 was highly dependent on calicheamicin sensitivity and CD22/CMC-544 internalization capacity of BCP-ALL cells, but hardly on basal and renewed CD22 expression. Although CD22 expression was essential for uptake of CMC-544, a repetitive loop of CD22 saturation, CD22/CMC-544 internalization and renewed CD22 expression was not required to achieve intracellular threshold levels of calicheamicin sufficient for efficient CMC-544-induced apoptosis in BCP-ALL cells. This is in contrast to studies with the comparable CD33 immunotoxin gemtuzumab ozogamicin (Mylotarg) in acute myeloid leukemia (AML) patients, in which complete and prolonged CD33 saturation was required for apoptosis induction. These data suggest that CMC-544 treatment may result in higher response rates in ALL compared with response rates obtained in AML with Mylotarg, and that therefore clinical studies in ALL, preferably with multiple low CMC-544 dosages, are warranted.

Testing the effectiveness of a self-efficacy based exercise intervention for inactive people with type 2 diabetes mellitus: design of a controlled clinical trial

PubMed Central

2012-01-01

Background Sufficient exercise is important for people with Type 2 Diabetes Mellitus (T2DM), as it can prevent future health problems. Despite, it is estimated that only 30-40% of people with T2DM are sufficiently active. One of the psychosocial constructs that is believed to influence physical activity behaviour, is exercise self-efficacy. The goal of this study is to evaluate a patient-tailored exercise intervention for people with T2DM that takes exercise self-efficacy into account. Methods/Design This study is conducted as a non-randomized controlled clinical trial. Patients are eligible when they are diagnosed with T2DM, exercise less than advised in the ADA guideline of 150 min/week of moderate-intensity aerobic physical activity, have an BMI >25 and are between 18 and 80 years old. Recruitment takes place at a Primary care organization of general practitioners and practice nurses in the south of the Netherlands. Participants are allocated to three groups: An advice intervention -for participants with a high exercise self-efficacy score- in which participants receive a patient-tailored exercise intervention, an intensive intervention -for participants with a low exercise self-efficacy score- in which participants receive a patient-tailored exercise intervention accomplished by a group based intervention, and a control group in which participants receive regular Dutch diabetes care. The primary outcome measure of this study is physical activity. Secondary outcome measures are health status, (symptoms of) depression, exercise self-efficacy, Body Mass Index (BMI), blood pressure and glycemic control. Discussion We aimed to design an intervention that can be implemented in Primary care, but also to design an easy accessible program. This study is innovative as it is -to our best knowledge- the first study that takes level of exercise self-efficacy of people with T2DM into account by means of giving extra support to those with the lowest exercise self-efficacy. If the program succeeds in increasing the amount of physical activity it can be implemented in regular primary care. Trial registration Dutch Trial Register NTR2734 PMID:22559322

Testing the effectiveness of a self-efficacy based exercise intervention for inactive people with type 2 diabetes mellitus: design of a controlled clinical trial.

PubMed

van der Heijden, Marion M P; Pouwer, François; Romeijnders, Arnold C; Pop, Victor J M

2012-07-04

Sufficient exercise is important for people with Type 2 Diabetes Mellitus (T2DM), as it can prevent future health problems. Despite, it is estimated that only 30-40% of people with T2DM are sufficiently active. One of the psychosocial constructs that is believed to influence physical activity behaviour, is exercise self-efficacy. The goal of this study is to evaluate a patient-tailored exercise intervention for people with T2DM that takes exercise self-efficacy into account. This study is conducted as a non-randomized controlled clinical trial. Patients are eligible when they are diagnosed with T2DM, exercise less than advised in the ADA guideline of 150 min/week of moderate-intensity aerobic physical activity, have an BMI >25 and are between 18 and 80 years old. Recruitment takes place at a Primary care organization of general practitioners and practice nurses in the south of the Netherlands.Participants are allocated to three groups: An advice intervention -for participants with a high exercise self-efficacy score- in which participants receive a patient-tailored exercise intervention, an intensive intervention -for participants with a low exercise self-efficacy score- in which participants receive a patient-tailored exercise intervention accomplished by a group based intervention, and a control group in which participants receive regular Dutch diabetes care. The primary outcome measure of this study is physical activity. Secondary outcome measures are health status, (symptoms of) depression, exercise self-efficacy, Body Mass Index (BMI), blood pressure and glycemic control. We aimed to design an intervention that can be implemented in Primary care, but also to design an easy accessible program. This study is innovative as it is -to our best knowledge- the first study that takes level of exercise self-efficacy of people with T2DM into account by means of giving extra support to those with the lowest exercise self-efficacy. If the program succeeds in increasing the amount of physical activity it can be implemented in regular primary care. Dutch Trial Register NTR2734.

Treatment of Rheumatoid Arthritis with Biologic DMARDS (Rituximab and Etanercept)

PubMed Central

Gashi, Afrim A.; Rexhepi, Sylejman; Berisha, Idriz; Kryeziu, Avni; Ismaili, Jehona; Krasniqi, Gezim

2014-01-01

ABSTRACT Goal: To determine efficacy and safety of treatment with Rituximab and Etanercept plus Methotrexate in patients with active Rheumatoid Arthritis (RA), who had an inadequate response to nonbiologic DMARDS therapies and to explore the pharmacogenetics and pharmacodynamics of Rituximab and Etanercept in our populations. Study was done at Rheumatology Clinic of University Clinical Centre in Prishtina during 2009-2011 years. Methods: We evaluated primary efficacy and safety at 24 weeks in patients enrolled in the study of long term efficacy of Rituximab and Etanercept. Patients with active Rheumatoid Arthritis and an inadequate response to 1 or more non biologic DMARDS were randomized to receive intravenous Rituximab (1 course consisting of 2 infusions of 1.000 mg each –one group, and Etanercept 25 mg twice weekly –second group, but both groups with background MTX. The primary efficacy end point was a response on the ACR 20%, improvement criteria at 24 weeks, Secondary end points were responses on the ACR 50 and ACR 70, improvement criteria, the DAS 28, and EULAR response criteria at 24 weeks. Results: During our investigations we treated 20 patients, 15 females and 5 males, in the treated group with RTX and 13 patients 8 females and 5 males in the treated group with ETN. Patients of group 1 and group 2 were of ages 37-69 years old and 19-69 years old (average 47-44) Most of the patients belong in 2nd and 3 rd functional stage according to Steinbrocker. All ACR response parameters were significantly improved in RTX treated patients who also had clinically meaningful improvement in fatigue, disability and quality of life. Patients showed a trend less progression in radiographic end points. Most adverse events occurred with the first RTX infusion and were mild to moderate severity. Conclusion: At 24 weeks, a single course of RTX and ETN provided significant and clinically meaningful improvements in disease activity in patients with active, longstanding RA who had an inadequate response to 1 or more nonbiologic DMARDS. PMID:24783914

Cognitive Behavioral Therapy vs. Tai Chi for Late Life Insomnia and Inflammatory Risk: A Randomized Controlled Comparative Efficacy Trial

PubMed Central

Irwin, Michael R.; Olmstead, Richard; Carrillo, Carmen; Sadeghi, Nina; Breen, Elizabeth C.; Witarama, Tuff; Yokomizo, Megumi; Lavretsky, Helen; Carroll, Judith E.; Motivala, Sarosh J.; Bootzin, Richard; Nicassio, Perry

2014-01-01

Study Objectives: To investigate the comparative efficacy of cognitive behavioral therapy (CBT), Tai Chi Chih (TCC), and sleep seminar education control (SS) on the primary outcome of insomnia diagnosis, and secondary outcomes of sleep quality, fatigue, depressive symptoms, and inflammation in older adults with insomnia. Design: Randomized controlled, comparative efficacy trial. Setting: Los Angeles community. Patients: 123 older adults with chronic and primary insomnia. Interventions: Random assignment to CBT, TCC, or SS for 2-hour group sessions weekly over 4 months with follow-up at 7 and 16 months. Measurements: Insomnia diagnosis, patient-reported outcomes, polysomnography (PSG), and high-sensitivity C-reactive protein (CRP) levels. Results: CBT performed better than TCC and SS in remission of clinical insomnia as ascertained by a clinician (P < 0.01), and also showed greater and more sustained improvement in sleep quality, sleep parameters, fatigue, and depressive symptoms than TCC and SS (all P values < 0.01). As compared to SS, CBT was associated with a reduced risk of high CRP levels (> 3.0 mg/L) at 16 months (odds ratio [OR], 0.26 [95% CI, 0.07–0.97] P < 0.05). Remission of insomnia was associated with lower levels of CRP (P < 0.05) at 16 months. TCC was associated with improvements in sleep quality, fatigue, and depressive symptoms as compared to SS (all P's < 0.05), but not insomnia remission. PSG measures did not change. Conclusions: Treatment of late-life insomnia is better achieved and sustained by cognitive behavioral therapies. Insomnia treatment and remission reduces a marker of inflammatory risk, which has implications for cardiovascular morbidity and diabetes observed with sleep disturbance in epidemiologic surveys. Clinical Trial Registration: ClinicalTrials.gov, NCT00280020 Citation: Irwin MR, Olmstead R, Carrillo C, Sadeghi N, Breen EC, Witarama T, Yokomizo M, Lavretsky H, Carroll JE, Motivala SJ, Bootzin R, Nicassio P. Cognitive behavioral therapy vs. Tai Chi for late life insomnia and inflammatory risk: a randomized controlled comparative efficacy trial. SLEEP 2014;37(9):1543-1552. PMID:25142571

Factors Associated with Primary School Teachers' Attitudes Towards the Inclusion of Students with Disabilities.

PubMed

Vaz, Sharmila; Wilson, Nathan; Falkmer, Marita; Sim, Angela; Scott, Melissa; Cordier, Reinie; Falkmer, Torbjörn

2015-01-01

Teachers' attitudes toward inclusion are often based on the practical implementation of inclusive education rather than a specific ideology and understanding of inclusiveness. This study aimed to identify the factors associated with primary school teachers' attitudes towards inclusion of students with all disabilities in regular schools. Seventy four primary school teachers participated in a cross-sectional survey conducted in Western Australia. Teachers' attitudes and efficacy toward integration of students with disabilities were measured using the Opinions Relative to Integration of Students with Disabilities scale and Bandura's Teacher Efficacy scale respectively. Four teacher attributes-age, gender, teaching self-efficacy and training collectively explained 42% of the variability in teachers' attitude toward including students with disabilities. The current study further contributes to the accumulation of knowledge that can unpack the complex pattern of factors that should be considered to promote positive attitudes towards inclusive schools.

Factors Associated with Primary School Teachers’ Attitudes Towards the Inclusion of Students with Disabilities

PubMed Central

Vaz, Sharmila; Wilson, Nathan; Falkmer, Marita; Sim, Angela; Scott, Melissa; Cordier, Reinie; Falkmer, Torbjörn

2015-01-01

Objective Teachers' attitudes toward inclusion are often based on the practical implementation of inclusive education rather than a specific ideology and understanding of inclusiveness. This study aimed to identify the factors associated with primary school teachers' attitudes towards inclusion of students with all disabilities in regular schools. Method Seventy four primary school teachers participated in a cross-sectional survey conducted in Western Australia. Teachers' attitudes and efficacy toward integration of students with disabilities were measured using the Opinions Relative to Integration of Students with Disabilities scale and Bandura's Teacher Efficacy scale respectively. Results Four teacher attributes—age, gender, teaching self-efficacy and training collectively explained 42% of the variability in teachers' attitude toward including students with disabilities. Conclusion The current study further contributes to the accumulation of knowledge that can unpack the complex pattern of factors that should be considered to promote positive attitudes towards inclusive schools. PMID:26317862

Design of a phase III multicenter trial to evaluate the efficacy of the RTS,S/AS01 malaria vaccine in children across diverse transmission settings in Africa

PubMed Central

2011-01-01

Background GlaxoSmithKline Biologicals and the PATH Malaria Vaccine Initiative are working in partnership to develop a malaria vaccine to protect infants and children living in malaria endemic regions of sub-Saharan Africa, which can be delivered through the Expanded Programme on Immunization. The RTS,S/AS candidate vaccine has been evaluated in multiple phase I/II studies and shown to have a favourable safety profile and to be well-tolerated in both adults and children. This paper details the design of the phase III multicentre efficacy trial of the RTS,S/AS01 malaria vaccine candidate, which is pivotal for licensure and policy decision-making. Methods The phase III trial is a randomized, controlled, multicentre, participant- and observer-blind study on-going in 11 centres associated with different malaria transmission settings in seven countries in sub-Saharan Africa. A minimum of 6,000 children in each of two age categories (6-12 weeks, 5-17 months) have been enrolled. Children were randomized 1:1:1 to one of three study groups: (1) primary vaccination with RTS,S/AS01 and booster dose of RTS,S/AS01; (2) primary vaccination with RTS,S/AS01 and a control vaccine at time of booster; (3) primary vaccination with control vaccine and a control vaccine at time of booster. Primary vaccination comprises three doses at monthly intervals; the booster dose is administered at 18 months post-primary course. Subjects will be followed to study month 32. The co-primary objectives are the evaluation of efficacy over one year post-dose 3 against clinical malaria when primary immunization is delivered at: (1) 6-12 weeks of age, with co-administration of DTPwHepB/Hib antigens and OPV; (2) 5-17 months of age. Secondary objectives include evaluation of vaccine efficacy against severe malaria, anaemia, malaria hospitalization, fatal malaria, all-cause mortality and other serious illnesses including sepsis and pneumonia. Efficacy of the vaccine against clinical malaria under different transmission settings, the evolution of efficacy over time and the potential benefit of a booster will be evaluated. In addition, the effect of RTS,S/AS01 vaccination on growth, and the safety and immunogenicity in HIV-infected and malnourished children will be assessed. Safety of the primary course of immunization and the booster dose will be documented in both age categories. Conclusions This pivotal phase III study of the RTS,S/AS01 candidate malaria vaccine in African children was designed and implemented by the Clinical Trials Partnership Committee. The study will provide efficacy and safety data to fulfil regulatory requirements, together with data on a broad range of endpoints that will facilitate the evaluation of the public health impact of the vaccine and will aid policy and implementation decisions. Trial registration Clinicaltrials.gov NCT00866619 PMID:21816029

Emotional exhaustion in primary care during early implementation of the VA's medical home transformation: Patient-aligned Care Team (PACT).

PubMed

Meredith, Lisa S; Schmidt Hackbarth, Nicole; Darling, Jill; Rodriguez, Hector P; Stockdale, Susan E; Cordasco, Kristina M; Yano, Elizabeth M; Rubenstein, Lisa V

2015-03-01

Transformation of primary care to new patient-centered models requires major changes in healthcare organizations, including interprofessional expectations and organizational policies. Emotional exhaustion (EE) among workers can accompany major organizational change, threatening its success. Yet little guidance exists about the magnitude of associations with EE during primary care transformation. We assessed EE during the initial phase of national primary care transformation in the Veterans Health Administration. Cross-sectional online surveys of primary care clinicians (PCCs) and staff in 23 primary care clinics within 5 healthcare systems in 1 veterans administration administrative region. We used descriptive, bivariate, and multivariable analyses adjusted for clinic membership and weighted for nonresponse. 515 veterans administration employees (191 PCCs and 324 other primary care staff). Outcome is the EE subscale of the Maslach Burnout Inventory. Predictors include clinic characteristics (from administrative data) and self-reported efficacy for change, experiences with transformation, and perspectives about the organization. The overall response rate was 64% (515/811). In total, 53% of PCCs and 43% of staff had high EE. PCCs (vs. other primary care staff), female (vs. male), and non-Latino (vs. Latino) respondents reported higher EE. Respondents reporting higher efficacy for change and participatory decision making had lower EE scores, adjusting for sex and race. Recognition by healthcare organizations of the potential for clinician and staff EE during primary care transformation is critical. Methods for reducing EE by increasing clinician and staff change efficacy and opportunities to participate in decision making should be considered, with attention to PCCs, and women.

A Study on the Relationship between Teacher Self Efficacy and Burnout

ERIC Educational Resources Information Center

Savas, Ahmet Cezmi; Bozgeyik, Yunus; Eser, Ismail

2014-01-01

The major purpose of the study was to examine the relationship between teacher self efficacy and burnout. In order to collect the related data, "Maslach Burnout Inventory" and "Teacher Sense of Efficacy Scale" were used. The sample of the study consisted of 163 randomly chosen teachers who worked in various primary and…

Pre-Service Teacher Self-Efficacy in Digital Technology

ERIC Educational Resources Information Center

Lemon, Narelle; Garvis, Susanne

2016-01-01

Self-efficacy is an important motivational construct for primary school teachers (teachers of children aged 5-12 years) within Australia. Teacher self-efficacy beliefs will determine the level of teacher confidence and competence to engage with a task. In this study, we explore engagement with digital technology and the associated learning and…

Use of a porcine collagen matrix as an alternative to autogenous tissue for grafting oral soft tissue defects.

PubMed

Herford, Alan S; Akin, Lee; Cicciu, Marco; Maiorana, Carlo; Boyne, Philip J

2010-07-01

Soft tissue grafting is often required to correct intraoral mucosal deficiencies. Autogenous grafts have disadvantages including an additional harvest site with its associated pain and morbidity and, sometimes, poor quality and limited amount of the graft. Porcine collagen matrices have the potential to be helpful for grafting of soft tissue defects. Thirty consecutive patients underwent intraoral grafting to re-create missing soft tissue. Defects ranged in size from 50 to 900 mm(2). Porcine collagen matrices were used to reconstruct missing tissue. Indications included preprosthetic (22), followed by tumor removal (5), trauma (2), and release of cheek ankylosis (1). The primary efficacy parameters evaluated were the degree of lateral and/or alveolar extension and the evaluation of re-epithelialization and shrinkage of the grafted area. Overall, the percentage of shrinkage of the graft was 14% (range, 5%-20%). The amount of soft tissue extension averaged 3.4 mm (range, 2-10 mm). The secondary efficacy parameters included hemostatic effect, pain evaluation, pain and discomfort, and clinical evaluation of the grafted site. All patients reported minimal pain and swelling associated with the grafted area. No infections were noted. This porcine collagen matrix provides a biocompatible surgical material as an alternative to an autogenous transplant, thus obviating the need to harvest soft tissue autogenous grafts from other areas of the oral cavity. Copyright 2010 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

Metabolic management in overweight subjects with naive impaired fasting glycaemia by means of a highly standardized extract from Cynara scolymus: a double-blind, placebo-controlled, randomized clinical trial.

PubMed

Rondanelli, Mariangela; Opizzi, Annalisa; Faliva, Milena; Sala, Patrizio; Perna, Simone; Riva, Antonella; Morazzoni, Paolo; Bombardelli, Ezio; Giacosa, Attilio

2014-01-01

The aim of this study is to evaluate the efficacy of a dietary supplementation with an extract from Cynara scolymus (Cs) on the glucose pattern in a group of patients with naïve impaired fasting glycaemia (IFG). A randomized, double-blind, placebo-controlled trial has been performed in 55 overweight subjects with IFG (fasting blood glucose [FBG]: 6.11 ± 0.56 mmol/l). These subjects were randomly assigned to supplement their diet with either an extract from Cs (600 mg/d) (26 subjects) or placebo (29 matched subjects) for 8 weeks. The decrease of FBG was the primary endpoint. The assessment of Homeostatic Metabolic Assessment (HOMA), glycosylated haemoglobin, A1c-Derived Average Glucose (ADAG), lipidic pattern and anthropometric parameters were the secondary endpoints. The within groups and percent changes from baseline were analyzed by the signed rank test. The comparison between groups was performed by Wilcoxon's two sample test. The supplemented group had significant decreases of: FBG (-9.6%), HOMA (-11.7%), glycosylated haemoglobin (-2.3%), ADAG (-3.1%) and lipidic pattern. The placebo group did not show any significant difference. Compared with the placebo, the supplemented group showed a significant difference in FBG, HOMA and lipidic pattern. These data demonstrate the efficacy of Cs extract on the reduction of glycometabolic parameters in overweight subjects with IFG. Copyright © 2013 John Wiley & Sons, Ltd.

Methodology of phase II clinical trials in metastatic elderly breast cancer: a literature review.

PubMed

Cabarrou, B; Mourey, L; Dalenc, F; Balardy, L; Kanoun, D; Roché, H; Boher, J M; Rougé-Bugat, M E; Filleron, Thomas

2017-08-01

As the incidence of invasive breast cancer will increase with age, the number of elderly patients with a diagnosis metastatic breast cancer will also rise. But the use of cytotoxic drugs in elderly metastatic breast cancer patients is not systematic and is dreaded by medical oncologists. The need for prospective oncologic data from this population seems increasingly obvious. The main objective of this review is to investigate design and characteristics of phase II trials that assess activity and feasibility of chemotherapies in elderly advanced/metastatic breast cancer patients. An electronic search in PUBMED allowed us to retrieve articles published in English language on phase II trials in elderly metastatic breast cancer between January 2002 and May 2016. Sixteen publications were finally included in this review. The primary endpoint was a simple, a composite, and a co-primary endpoints in 11, three, and two studies, respectively. Efficacy was the primary objective in 15 studies: simple (n = 10), composite (n = 3), co-primary endpoints (n = 2). Composite or co-primary endpoints combined efficacy and toxicity. Thirteen studies used multistage designs. Only five studies evaluated the feasibility, i.e., to jointly assess efficacy and tolerance to treatment (toxicity, quality of life, etc) as primary endpoint. Development of elderly specific phase III clinical trials might be challenging, it therefore seems essential to conduct phase II clinical trials evaluating jointly efficacy and toxicity in a well-defined geriatric population. Use of multistage designs that take into account heterogeneity would allow to identify a subpopulation at interim analysis and to reduce the number of patients exposed to an inefficient or a toxic treatment regimen. It is crucial to evaluate new therapies (targeted therapies, immunotherapies) using adequate methodologies (Study design, endpoint).

Rivaroxaban versus warfarin in Japanese patients with nonvalvular atrial fibrillation for the secondary prevention of stroke: a subgroup analysis of J-ROCKET AF.

PubMed

Tanahashi, Norio; Hori, Masatsugu; Matsumoto, Masayasu; Momomura, Shin-ichi; Uchiyama, Shinichiro; Goto, Shinya; Izumi, Tohru; Koretsune, Yukihiro; Kajikawa, Mariko; Kato, Masaharu; Ueda, Hitoshi; Iwamoto, Kazuya; Tajiri, Masahiro

2013-11-01

The overall analysis of the rivaroxaban versus warfarin in Japanese patients with atrial fibrillation (J-ROCKET AF) trial revealed that rivaroxaban was not inferior to warfarin with respect to the primary safety outcome. In addition, there was a strong trend for a reduction in the rate of stroke/systemic embolism with rivaroxaban compared with warfarin. In this subanalysis of the J-ROCKET AF trial, we investigated the consistency of safety and efficacy profile of rivaroxaban versus warfarin among the subgroups of patients with previous stroke, transient ischemic attack, or non-central nervous system systemic embolism (secondary prevention group) and those without (primary prevention group). Patients in the secondary prevention group were 63.6% of the overall population of J-ROCKET AF. In the secondary prevention group, the rate of the principal safety outcome (% per year) was 17.02 in rivaroxaban-treated patients and 18.26 in warfarin-treated patients (hazard ratio [HR] 0.95; 95% confidence interval [CI] 0.70-1.29), while the rate of the primary efficacy endpoint was 1.66 in rivaroxaban-treated patients and 3.25 in warfarin-treated patients (HR 0.51; 95% CI 0.23-1.14). There were no significant interactions in the principal safety and the primary efficacy endpoints of rivaroxaban compared to warfarin between the primary and secondary prevention groups (P=.090 and .776 for both interactions, respectively). The safety and efficacy profile of rivaroxaban compared with warfarin was consistent among patients in the primary prevention group and those in the secondary prevention group. Copyright © 2013 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Primary Care Residents' Knowledge, Attitudes, Self-Efficacy, and Perceived Professional Norms Regarding Obesity, Nutrition, and Physical Activity Counseling.

PubMed

Smith, Samantha; Seeholzer, Eileen L; Gullett, Heidi; Jackson, Brigid; Antognoli, Elizabeth; Krejci, Susan A; Flocke, Susan A

2015-09-01

Obesity and being overweight are both significant risk factors for multiple chronic conditions. Primary care physicians are in a position to provide health behavior counseling to the majority of US adults, yet most report insufficient training to deliver effective counseling for obesity. To assess the degree to which residents training in adult primary care programs are prepared to provide obesity, nutrition, and physical activity (ONPA) counseling. Senior residents (postgraduate year [PGY]-3 and PGY-4) from 25 Ohio family medicine, internal medicine, and obstetrics and gynecology programs were surveyed regarding their knowledge about obesity risks and effective counseling, as well as their attitudes, self-efficacy, and perceived professional norms toward ONPA counseling. We examined summary scores, and used regression analyses to assess associations with resident demographics and training program characteristics. A total of 219 residents participated (62% response rate). Mean ONPA counseling knowledge score was 50.8 (± 15.6) on a 0 to 100 scale. Specialty was associated with counseling self-efficacy (P < .001) and perceived norms (P = .002). Residents who reported having engaged in an elective rotation emphasizing ONPA counseling had significantly higher self-efficacy and more positive attitudes and professional norms scores. Our findings suggest that primary care residents' knowledge of ONPA assessment and management strategies has room for improvement. Attitudes, self-efficacy, and perceived norms also are low and vary by training program characteristics. A deeper understanding of curricula associated with improved performance in these domains could inform interventions to enhance residents' ONPA counseling skills and prevent chronic disease.

Improved photosynthetic efficacy of maize (Zea mays) plants with arbuscular mycorrhizal fungi (AMF) under high temperature stress.

PubMed

Mathur, Sonal; Sharma, Mahaveer P; Jajoo, Anjana

2018-03-01

In this study, pot experiments were performed to investigate the effects of high temperature stress (44 °C) in maize plants colonized with and without arbuscular mycorrhizal fungi (AMF). Various parameters characterizing photosynthetic activity were measured in order to estimate the photosynthetic efficiency in maize plants. It was observed that density of active reaction centers of PSII, quantum efficiency of photosystem II (PSII), linear electron transport, excitation energy trapping, performance index, net photosynthesis rate increased in AMF (+) plants at 44 °C ± 0.2 °C. Efficiency of primary photochemical reaction (represented as F v /F o ) increased in AMF (+) plants as compared to AMF (-) plants. AMF seems to have protected water splitting complex followed by enhanced primary photochemistry of PSII under high temperature. Basic morphological parameters like leaf width, plant height and cob number increased in AMF (+) plants as compared to AMF (-) plants. AMF (+) plants grew faster than AMF (-) plants due to larger root systems. Chl content increased in AMF (+) plants as compared to AMF (-) maize plants. AMF hyphae likely increased Mg uptake which in turn increased the total chlorophyll content in AMF (+) maize plants. This subsequently led to a higher production in photosynthate and biomass. Thus AMF (+) plants have shown better photosynthesis performance as compared to AMF (-) maize plants under high temperature stress. Copyright © 2018 Elsevier B.V. All rights reserved.

Efficacy and tolerability of pale sulfonated shale oil cream 4% in the treatment of mild to moderate atopic eczema in children: a multicentre, randomized vehicle-controlled trial.

PubMed

Korting, H C; Schöllmann, C; Cholcha, W; Wolff, L

2010-10-01

Reports on controlled trials on the efficacy and tolerability of sulfonated shale oils in atopic eczema are not available so far. The aim of this study was to investigate whether topically applied, specially prepared pale sulfonated shale oil (PSSO) cream is capable of improving symptoms/signs of mild to moderate atopic eczema in children more efficaciously than a corresponding vehicle cream. A total of 99 children suffering from mild to moderate atopic eczema were enrolled in this multicentre, randomized, vehicle-controlled study. Verum or vehicle cream was applied to the affected skin area three times a day over 4 weeks. As the primary outcome parameter served the reduction of the total score after 4 weeks of treatment, compared with the initial examination. Secondary outcome parameters were addressed as well. Tolerability was judged by investigators and patients/parents, and adverse events were documented. After 4 weeks of treatment, the total score declined from 13.4 ± 3.7 to 4.5 ± 7.4 score points in the verum group and from 13.0 ± 3.1 to 11.7 ± 8.6 score points in the vehicle group (P < 0.0001). The superiority of verum regarding total score was already apparent after a treatment period of 1 week (reduction by 5.6 ± 4.3 vs. 1.3 ± 5.9 score points; P < 0.0001). Tolerability was found superior at the end of the treatment in the verum when compared with the control group--both by investigators (P < 0.0001) and patients/parents (P = 0.0051). Pale sulfonated shale oil cream 4% is capable to treat mild to moderate atopic eczema in children more efficaciously than vehicle and is well tolerated. PSSO thus represents a valuable addition to our therapeutic armamentarium. PSSO should be considered in particular when valid alternatives for topical glucocorticoids are sought for. © 2010 The Authors. Journal of the European Academy of Dermatology and Venereology © 2010 European Academy of Dermatology and Venereology.

Revisiting the cost-effectiveness of universal cervical length screening: importance of progesterone efficacy.

PubMed

Jain, Siddharth; Kilgore, Meredith; Edwards, Rodney K; Owen, John

2016-07-01

Preterm birth (PTB) is a significant cause of neonatal morbidity and mortality. Studies have shown that vaginal progesterone therapy for women diagnosed with shortened cervical length can reduce the risk of PTB. However, published cost-effectiveness analyses of vaginal progesterone for short cervix have not considered an appropriate range of clinically important parameters. To evaluate the cost-effectiveness of universal cervical length screening in women without a history of spontaneous PTB, assuming that all women with shortened cervical length receive progesterone to reduce the likelihood of PTB. A decision analysis model was developed to compare universal screening and no-screening strategies. The primary outcome was the cost-effectiveness ratio of both the strategies, defined as the estimated patient cost per quality-adjusted life-year (QALY) realized by the children. One-way sensitivity analyses were performed by varying progesterone efficacy to prevent PTB. A probabilistic sensitivity analysis was performed to address uncertainties in model parameter estimates. In our base-case analysis, assuming that progesterone reduces the likelihood of PTB by 11%, the incremental cost-effectiveness ratio for screening was $158,000/QALY. Sensitivity analyses show that these results are highly sensitive to the presumed efficacy of progesterone to prevent PTB. In a 1-way sensitivity analysis, screening results in cost-saving if progesterone can reduce PTB by 36%. Additionally, for screening to be cost-effective at WTP=$60,000 in three clinical scenarios, progesterone therapy has to reduce PTB by 60%, 34% and 93%. Screening is never cost-saving in the worst-case scenario or when serial ultrasounds are employed, but could be cost-saving with a two-day hospitalization only if progesterone were 64% effective. Cervical length screening and treatment with progesterone is a not a dominant, cost-effective strategy unless progesterone is more effective than has been suggested by available data for US women. Until future trials demonstrate greater progesterone efficacy, and effectiveness studies confirm a benefit from screening and treatment, the cost-effectiveness of universal cervical length screening in the United States remains questionable. Copyright © 2016 Elsevier Inc. All rights reserved.

Role of motor cortex NMDA receptors in learning-dependent synaptic plasticity of behaving mice

PubMed Central

Hasan, Mazahir T.; Hernández-González, Samuel; Dogbevia, Godwin; Treviño, Mario; Bertocchi, Ilaria; Gruart, Agnès; Delgado-García, José M.

2013-01-01

The primary motor cortex has an important role in the precise execution of learned motor responses. During motor learning, synaptic efficacy between sensory and primary motor cortical neurons is enhanced, possibly involving long-term potentiation and N-methyl-D-aspartate (NMDA)-specific glutamate receptor function. To investigate whether NMDA receptor in the primary motor cortex can act as a coincidence detector for activity-dependent changes in synaptic strength and associative learning, here we generate mice with deletion of the Grin1 gene, encoding the essential NMDA receptor subunit 1 (GluN1), specifically in the primary motor cortex. The loss of NMDA receptor function impairs primary motor cortex long-term potentiation in vivo. Importantly, it impairs the synaptic efficacy between the primary somatosensory and primary motor cortices and significantly reduces classically conditioned eyeblink responses. Furthermore, compared with wild-type littermates, mice lacking primary motor cortex show slower learning in Skinner-box tasks. Thus, primary motor cortex NMDA receptors are necessary for activity-dependent synaptic strengthening and associative learning. PMID:23978820

Effect of Vaccine Administration Modality on Immunogenicity and Efficacy

PubMed Central

Zhang, Lu; Wang, Wei; Wang, Shixia

2016-01-01

Summary The many factors impacting the efficacy of a vaccine can be broadly divided into three categories: (1) features of the vaccine itself, including immunogen design, vaccine type, formulation, adjuvant, and dosing; (2) individual variations among vaccine recipients; and (3) vaccine administration-related parameters. While much literature exists related to vaccines, and recently systems biology has started to dissect the impact of individual subject variation on vaccine efficacy, few studies have focused on the role of vaccine administration-related parameters on vaccine efficacy. Parenteral and mucosal vaccinations are traditional approaches for licensed vaccines; novel vaccine delivery approaches, including needless injection and adjuvant formulations, are being developed to further improve vaccine safety and efficacy. This review provides a brief summary of vaccine administration-related factors, including vaccination approach, delivery route, and method of administration, to gain a better understanding of their potential impact on the safety and immunogenicity of candidate vaccines. PMID:26313239

Highly purified human-derived follicle-stimulating hormone (Bravelle®) has equivalent efficacy to follitropin-beta (Follistim ®) in infertile women undergoing in vitro fertilization

PubMed Central

Dickey, Richard P; Nichols, John E; Steinkampf, Michael P; Gocial, Benjamin; Thornton, Melvin; Webster, Bobby W; Bello, Sandra M; Crain, Jack; Marshall, Dennis C

2003-01-01

Background These data compare the efficacy and safety of highly purified human-derived follicle-stimulating hormone (Bravelle(R)) and recombinant follitropin-β (Follistim(R)) in women undergoing in vitro fertilization. Methods This report describes the pooled data from two, nearly identical, randomized, controlled, parallel-group, multicenter studies conducted in a total of 19 academic and private IVF-ET centers in the United States. Infertile premenopausal women underwent pituitary down-regulation using leuprolide acetate followed by a maximum of 12 days of subcutaneous Bravelle(R) (n = 120) or Follistim(R) (n = 118), followed by administration of human chorionic gonadotropin, oocyte retrieval and embryo transfer. The primary efficacy measure was the mean number of oocytes retrieved; secondary efficacy measures included the total dose and duration of gonadotropin treatment; peak serum estradion levels; embryo transfer and implantation rates; chemical, clinical and continuing pregnancies; and live birth rates. All adverse events were recorded and injection site pain was recorded daily using a patient, self-assessment diary. Results Similar efficacy responses were observed for all outcome parameters in the two treatment groups. Although patients receiving Bravelle(R) consistently reported a greater number of chemical, clinical and continuing pregnancies, as well as an increased rate of live birth, the data did not attain statistical significance (P > 0.05). The overall incidence of adverse events was similar in both groups, but compared to Follistim(R), injections of Bravelle(R) were reported by patients to be significantly less painful (P < 0.001). Conclusions Bravelle(R) and Follistim(R) had comparable efficacy in controlled ovarian hyperstimulation in women undergoing IVF-ET. There were no differences in the nature or number of adverse events between the treatment groups although Bravelle(R) injections were reported to be significantly less painful. PMID:14609434

Efficacy and safety of brexpiprazole for the treatment of acute schizophrenia in Japan: A 6-week, randomized, double-blind, placebo-controlled study.

PubMed

Ishigooka, Jun; Iwashita, Shuichi; Tadori, Yoshihiro

2018-05-18

This study aimed to evaluate the efficacy, safety, and tolerability of brexpiprazole compared to placebo in Japanese patients with acute schizophrenia. We conducted a 6-week, multicenter, double-blind, placebo-controlled, phase 2/3 study in Japan. Patients with acute schizophrenia were randomized (1:1:1:1) to receive brexpiprazole 1, 2, or 4 mg or placebo once a day. The primary endpoint was the change from baseline to week 6 in Positive and Negative Syndrome Scale (PANSS) total scores. In the 459 patients that were randomized, brexpiprazole 2 mg showed a significant improvement versus placebo (treatment difference: -7.32, p = 0.0124), although brexpiprazole 4 mg showed numerical improvements (treatment difference: -3.86, p = 0.1959), and brexpiprazole 1 mg showed only minimal change (treatment difference: -0.63, p = 0.8330). The treatment-emergent adverse events (TEAEs) with an incidence of ≥5% and ≥2 times the rate of placebo in the brexpiprazole groups were vomiting, elevated blood prolactin, diarrhoea, nausea, and dental caries. Most TEAEs were mild or moderate in severity. There were no clinically significant changes in electrocardiogram parameters, body weight, laboratory values, and vital signs in the brexpiprazole groups. Brexpiprazole was efficacious and well tolerated in Japanese adult patients with acute schizophrenia. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Comparison of cleaning Efficacy and Instrumentation Time between Rotary and Manual Instrumentation Techniques in Primary Teeth: An in vitro Study.

PubMed

Katge, Farhin; Chimata, Vamsi Krishna; Poojari, Manohar; Shetty, Shilpa; Rusawat, Bhavesh

2016-01-01

The aim of this study was to compare the cleaning efficacy and instrumentation time between manual Hedstrom files (H-files) and rotary Mtwo files in primary molar root canals. A total of 90 primary root canals were selected using standardized radiographs. The canals were injected with India ink with 30 gauge insulin syringe and divided into three groups. Group I-30 root canals instrumented with H-files, group II-30 root canals instrumented with Mtwo files, and group III-control group in which no canal instrumentation was done. The teeth were cleared in various solutions and then observed under a stereomicroscope. No significant difference was seen in cleaning efficacy between H-files and Mtwo files in coronal, middle, and apical thirds of the root canal. The instrumentation time recorded for H-files (3.41 ± 0.38 minutes) was significantly less than that of Mtwo files (4.81 ± 0.52). Although there was no significant difference in cleaning capacity, further studies should be carried out using the single file systems. How to cite this article: Katge F, Chimata VK, Poojari M, Shetty S, Rusawat B. Comparison of cleaning Efficacy and Instrumentation Time between Rotary and Manual Instrumentation Techniques in Primary Teeth: An in vitro Study. Int J Clin Pediatr Dent 2016;9(2):124-127.

[Prognostic criteria of efficacy of programmed laparoscopic sanitation of the abdominal cavity in peritonitis].

PubMed

Salakhov, E K; Vlasov, A P; Bolotskyh, V A

To define prognostic criteria of efficacy of programmed laparoscopic sanitation of the abdominal cavity in peritonitis. There were 32 patients after programmed laparoscopic sanitation of abdominal cavity for peritonitis due to different acute surgical diseases. Subsequently 12 of them required relaparotomy due to poor effectiveness of laparoscopic sanitation. Comprehensive clinical examination and laboratory assessment of some indexes of homeostasis and oxidative status were conducted. Prognostic clinical and laboratory criteria of efficacy of laparoscopic abdominal sanitation were suggested after analysis of intraoperative data during primary surgery and laboratory values in the 1st postoperative day. The offered prognostic criteria allow to define further management of peritonitis patients after primary laparotomy.

Application of Cox model in coagulation function in patients with primary liver cancer.

PubMed

Guo, Xuan; Chen, Mingwei; Ding, Li; Zhao, Shan; Wang, Yuefei; Kang, Qinjiong; Liu, Yi

2011-01-01

To analyze the distribution of coagulation parameters in patients with primary liver cancer; explore the relationship between clinical staging, survival, and coagulation parameters by using Coxproportional hazard model; and provide a parameter for clinical management and prognosis. Coagulation parameters were evaluated in 228 patients with primary liver cancer, 52 patients with common liver disease, and 52 normal healthy controls. The relationship between primary livercancer staging and coagulation parameters wasanalyzed. Follow-up examinations were performed. The Cox proportional hazard model was used to analyze the relationship between coagulationparameters and survival. The changes in the coagulation parameters in patients with primary liver cancer were significantly different from those in normal controls. The effect of the disease on coagulation function became more obvious as the severity of liver cancer increased (p<0.05). The levels of D-dimer, fibrinogen degradation products (FDP), fibrinogen (FIB), and platelets (PLT) were negatively correlated with the long-term survival of patients with advanced liver cancer. The stages of primary liver cancer are associated with coagulation parameters. Coagulation parameters are related to survival and risk factors. Monitoring of coagulation parameters may help ensure better surveillance and treatment for liver cancer patients.

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

PubMed

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/.

Pre-Service Teachers' Efficacy Beliefs and Concerns in Malaysia, England and New Zealand

ERIC Educational Resources Information Center

Berg, David A. G.; Smith, Lisa F.

2014-01-01

This study compared perceptions of teacher efficacy beliefs and concerns about teaching in pre-service teacher cohorts from New Zealand, Malaysia, and England. Participants were primary pre-service teachers from Malaysia (n = 53), New Zealand (n = 100), and England (n = 119), who completed the Teachers' Sense of Efficacy (long form)…

Methylphenidate Transdermal System in Adults with Past Stimulant Misuse: An Open-Label Trial

ERIC Educational Resources Information Center

McRae-Clark, Aimee L.; Brady, Kathleen T.; Hartwell, Karen J.; White, Kathleen; Carter, Rickey E.

2011-01-01

Objective: This 8-week, open-label trial assessed the efficacy of methylphenidate transdermal system (MTS) in 14 adult individuals diagnosed with ADHD and with a history of stimulant misuse, abuse, or dependence. Method: The primary efficacy endpoint was the Wender-Reimherr Adult ADHD Scale (WRAADS), and secondary efficacy endpoints included the…

Requisite to Great Undertakings: Impacts of Self-Efficacy Beliefs in College Composition Instructors

ERIC Educational Resources Information Center

Sanchez, Kendall

2017-01-01

This dissertation addresses the problem of teacher self-efficacy theory being largely absent as a concept of study in composition studies, despite the field maintaining a primary focus on issues like teacher development and effective composition pedagogy. This absence of the study of teacher self-efficacy, defined as "a [teacher's] judgment…

Predictive Power of the Sources of Primary School Students' Self-Efficacy Beliefs on Their Self-Efficacy Beliefs for Learning and Performance

ERIC Educational Resources Information Center

Arslan, Ali

2012-01-01

The purpose of this study is to reveal the extent to which the sources of 6th- 8th grade students' self-efficacy beliefs predict their self-efficacy beliefs for learning and performance. The study is correlational and was conducted on a total of 1049 students during the fall term of the educational year 2010-2011. The data of the study were…

From Efficacy to Effectiveness and Beyond: What Next for Brief Interventions in Primary Care?

PubMed Central

O’Donnell, Amy; Wallace, Paul; Kaner, Eileen

2014-01-01

Background: Robust evidence supports the effectiveness of screening and brief alcohol interventions in primary healthcare. However, lack of understanding about their “active ingredients” and concerns over the extent to which current approaches remain faithful to their original theoretical roots has led some to demand a cautious approach to future roll-out pending further research. Against this background, this paper provides a timely overview of the development of the brief alcohol intervention evidence base to assess the extent to which it has achieved the four key levels of intervention research: efficacy, effectiveness, implementation, and demonstration. Methods: Narrative overview based on (1) the results of a review of systematic reviews and meta-analyses of the effectiveness of brief alcohol intervention in primary healthcare and (2) synthesis of the findings of key additional primary studies on the improvement and evaluation of brief alcohol intervention implementation in routine primary healthcare. Results: The brief intervention field seems to constitute an almost perfect example of the evaluation of a complex intervention. Early evaluations of screening and brief intervention approaches included more tightly controlled efficacy trials and have been followed by more pragmatic trials of effectiveness in routine clinical practice. Most recently, attention has shifted to dissemination, implementation, and wider-scale roll-out. However, delivery in routine primary health remains inconsistent, with an identified knowledge gap around how to successfully embed brief alcohol intervention approaches in mainstream care, and as yet unanswered questions concerning what specific intervention component prompt the positive changes in alcohol consumption. Conclusion: Both the efficacy and effectiveness of brief alcohol interventions have been comprehensively demonstrated, and intervention effects seem replicable and stable over time, and across different study contexts. Thus, while unanswered questions remain, given the positive evidence amassed to date, research efforts should maintain a continued focus on promoting sustained implementation of screening and brief alcohol intervention approaches in primary care to ensure that those who might benefit from screening and brief alcohol interventions actually receive such support. PMID:25221524

The efficacy of topical 0.05 % cyclosporine A in patients with dry eye disease associated with Sjögren's syndrome.

PubMed

Devecı, Hülya; Kobak, Senol

2014-10-01

Sjögren's syndrome (SS) is an autoimmune epithelitis which usually presents with mouth and eye dryness. Although the place of systemic drugs in keratoconjunctivitis sicca treatment has been discussed, the efficacy of some topical drugs has also been demonstrated; however, there are contradictory results related to topical cyclosporine A. We aimed to investigate the efficacy of 0.05 % topical cyclosporine A in patients with keratoconjunctivitis sicca due to primary and secondary SS. This prospective study included 26 patients with a diagnosis of primary and secondary SS who visited our rheumatology outpatient clinic. Keratoconjunctivitis sicca was diagnosed in all patients after they were examined at the outpatient clinic. Patients were given topical 0.05 % cyclosporine A emulsions for both eyes. We used another 20 patients with SS who were treated with saline solution as a control group. Subjective symptoms reported after 1-week and 1-month follow-up were complaints of burning and pricking sensation, light sensitivity and pain. Objective signs included redness, Schirmer test and tear break-up time. A total of 26 patients (19 female) were enrolled in the study with a mean age of 47.5 years and mean disease duration of 5.2 years. In the first physical examination of patients, 23 patients had burning and pricking sensation, 24 had pain, 23 had light sensitivity, and 24 had red eyes. All subjective symptoms (burning and pricking sensation, light sensitivity and pain) were statistically significantly improved after 1-week and 1-month follow-up examinations (p = 0.0001). All objective signs (Schirmer test, tear break-up time, and redness) were statistically significantly improved after 1-week and 1-month follow-up examinations (p = 0.0001). Compared with the control group, there was significant improvement in all parameters. It is concluded that topical 0.05 % cyclosporine A is an effective treatment option for keratoconjunctivitis sicca due to SS after a 1-month follow-up period.

Evaluation of Safety and Efficacy of Qinming8631 DR Implantable Cardiac Pacemaker in Chinese Patients: A Prospective, Multicenter, Randomized Controlled Trial of the First Domestically Developed Pacemaker of China.

PubMed

Xiang, Mei-Xiang; Wang, Dong-Qi; Xu, Jing; Zhang, Zheng; Hu, Jian-Xin; Wang, Dong-Mei; Gu, Xiang; Liu, He-Ping; Guo, Tao; Yang, Xiang-Jun; Ling, Feng; Lin, Jia-Feng; Cai, Shang-Lang; Zhu, Guo-Bin; Wang, Jian-An

2016-11-20

High cost of imported pacemakers is a main obstacle for Chinese patients suffering from bradyarrhythmia, and a domestically developed pacemaker will help lower the burden. This study aimed to evaluate the safety and efficacy of Qinming8631 DR (Qinming Medical, Baoji, China), the first domestically developed dual-chamber pacemaker of China, compared with a commercially available pacemaker Talos DR (Biotronik, Berlin, Germany) in Chinese patients. A prospective randomized trial was conducted at 14 centers in China. Participants were randomized into trial (Qinming8631 DR) and control (Talos DR) groups. Parameters of the pacing systems were collected immediately after device implantation and during follow-ups. The effective pacing rate at 6-month follow-up was recorded as the primary end point. Electrical properties, magnet response, single- and double-pole polarity conversion, rate response function, and adverse events of the pacing system were analyzed. The Cochran-Mantel-Haenszel Chi-square test, paired t-test, and Wilcoxon signed-rank test were used for measuring primary qualitative outcomes and comparing normally and abnormally distributed measurement data. A total of 225 patients with a diagnosis of bradyarrhythmia and eligible for this study were randomly enrolled into the trial (n = 113) and control (n = 112) groups. They underwent successful pacemaker implantation with acceptable postoperative pacing threshold and sensitivity. Effective pacing rates of trial and control groups were comparable both in the full analysis set and the per protocol set (81.4% vs. 79.5%, P = 0.712 and 95.4% vs. 89.5%, P = 0.143, respectively). In both data sets, noninferiority of the trial group was above the predefined noninferiority limit(-9.5%). This study established the noninferiority of Qinming8631 DR to Talos DR. The safety and efficacy of Qinming8631 DR pacemaker were comparable to those of Talos DR in treating patients with cardiac bradyarrhythmia.

Efficacy and Safety of Doxepin 1 mg, 3 mg, and 6 mg in Adults with Primary Insomnia

PubMed Central

Roth, Thomas; Rogowski, Roberta; Hull, Steven; Schwartz, Howard; Koshorek, Gail; Corser, Bruce; Seiden, David; Lankford, Alan

2007-01-01

Study Objectives: To evaluate the efficacy and safety of doxepin 1, 3, and 6 mg in insomnia patients. Design: Adults (18-64 y) with chronic primary insomnia (DSM-IV) were randomly assigned to one of four sequences of 1 mg, 3 mg, and 6 mg of doxepin, and placebo in a crossover study. Treatment periods consisted of 2 polysomnographic assessment nights with a 5-day or 12-day drug-free interval between periods. Efficacy was assessed using polysomnography (PSG) and patient-reported measures. Safety analyses included measures of residual sedation and adverse events. Measurements and Results: Sixty-seven patients were randomized. Wake time during sleep, the a priori defined primary endpoint, was statistically significantly improved at the doxepin 3 mg and 6 mg doses versus placebo. All three doses had statistically significant improvements versus placebo for PSG-defined wake after sleep onset, total sleep time, and overall sleep efficiency (SE). SE in the final third-of-the-night also demonstrated statistically significant improvement at all doses. The doxepin 6 mg dose significantly reduced subjective latency to sleep onset. All three doxepin doses had a safety profile comparable to placebo. There were no statistically significant differences in next-day residual sedation, and sleep architecture was generally clinically preserved. Conclusions: In adults with primary insomnia, doxepin 1 mg, 3 mg, and 6 mg was well-tolerated and produced improvement in objective and subjective sleep maintenance and duration endpoints that persisted into the final hour of the night. The side-effect profile was comparable to placebo, with no reported anticholinergic effects, no memory impairment, and no significant hangover/next-day residual effects. These data demonstrate that doxepin 1 mg, 3 mg, and 6 mg is efficacious in improving the sleep of patients with chronic primary insomnia. Citation: Roth T; Rogowski R; Hull S; Schwartz H; Koshorek G; Corser B; Seiden D. Efficacy and safety of doxepin 1 mg, 3 mg, and 6 mg in adults with primary insomnia. SLEEP 2007;30(11):1555-1561. PMID:18041488

Model Based Targeting of IL-6-Induced Inflammatory Responses in Cultured Primary Hepatocytes to Improve Application of the JAK Inhibitor Ruxolitinib

PubMed Central

Sobotta, Svantje; Raue, Andreas; Huang, Xiaoyun; Vanlier, Joep; Jünger, Anja; Bohl, Sebastian; Albrecht, Ute; Hahnel, Maximilian J.; Wolf, Stephanie; Mueller, Nikola S.; D'Alessandro, Lorenza A.; Mueller-Bohl, Stephanie; Boehm, Martin E.; Lucarelli, Philippe; Bonefas, Sandra; Damm, Georg; Seehofer, Daniel; Lehmann, Wolf D.; Rose-John, Stefan; van der Hoeven, Frank; Gretz, Norbert; Theis, Fabian J.; Ehlting, Christian; Bode, Johannes G.; Timmer, Jens; Schilling, Marcel; Klingmüller, Ursula

2017-01-01

IL-6 is a central mediator of the immediate induction of hepatic acute phase proteins (APP) in the liver during infection and after injury, but increased IL-6 activity has been associated with multiple pathological conditions. In hepatocytes, IL-6 activates JAK1-STAT3 signaling that induces the negative feedback regulator SOCS3 and expression of APPs. While different inhibitors of IL-6-induced JAK1-STAT3-signaling have been developed, understanding their precise impact on signaling dynamics requires a systems biology approach. Here we present a mathematical model of IL-6-induced JAK1-STAT3 signaling that quantitatively links physiological IL-6 concentrations to the dynamics of IL-6-induced signal transduction and expression of target genes in hepatocytes. The mathematical model consists of coupled ordinary differential equations (ODE) and the model parameters were estimated by a maximum likelihood approach, whereas identifiability of the dynamic model parameters was ensured by the Profile Likelihood. Using model simulations coupled with experimental validation we could optimize the long-term impact of the JAK-inhibitor Ruxolitinib, a therapeutic compound that is quickly metabolized. Model-predicted doses and timing of treatments helps to improve the reduction of inflammatory APP gene expression in primary mouse hepatocytes close to levels observed during regenerative conditions. The concept of improved efficacy of the inhibitor through multiple treatments at optimized time intervals was confirmed in primary human hepatocytes. Thus, combining quantitative data generation with mathematical modeling suggests that repetitive treatment with Ruxolitinib is required to effectively target excessive inflammatory responses without exceeding doses recommended by the clinical guidelines. PMID:29062282

Model Based Targeting of IL-6-Induced Inflammatory Responses in Cultured Primary Hepatocytes to Improve Application of the JAK Inhibitor Ruxolitinib.

PubMed

Sobotta, Svantje; Raue, Andreas; Huang, Xiaoyun; Vanlier, Joep; Jünger, Anja; Bohl, Sebastian; Albrecht, Ute; Hahnel, Maximilian J; Wolf, Stephanie; Mueller, Nikola S; D'Alessandro, Lorenza A; Mueller-Bohl, Stephanie; Boehm, Martin E; Lucarelli, Philippe; Bonefas, Sandra; Damm, Georg; Seehofer, Daniel; Lehmann, Wolf D; Rose-John, Stefan; van der Hoeven, Frank; Gretz, Norbert; Theis, Fabian J; Ehlting, Christian; Bode, Johannes G; Timmer, Jens; Schilling, Marcel; Klingmüller, Ursula

2017-01-01

IL-6 is a central mediator of the immediate induction of hepatic acute phase proteins (APP) in the liver during infection and after injury, but increased IL-6 activity has been associated with multiple pathological conditions. In hepatocytes, IL-6 activates JAK1-STAT3 signaling that induces the negative feedback regulator SOCS3 and expression of APPs. While different inhibitors of IL-6-induced JAK1-STAT3-signaling have been developed, understanding their precise impact on signaling dynamics requires a systems biology approach. Here we present a mathematical model of IL-6-induced JAK1-STAT3 signaling that quantitatively links physiological IL-6 concentrations to the dynamics of IL-6-induced signal transduction and expression of target genes in hepatocytes. The mathematical model consists of coupled ordinary differential equations (ODE) and the model parameters were estimated by a maximum likelihood approach, whereas identifiability of the dynamic model parameters was ensured by the Profile Likelihood. Using model simulations coupled with experimental validation we could optimize the long-term impact of the JAK-inhibitor Ruxolitinib, a therapeutic compound that is quickly metabolized. Model-predicted doses and timing of treatments helps to improve the reduction of inflammatory APP gene expression in primary mouse hepatocytes close to levels observed during regenerative conditions. The concept of improved efficacy of the inhibitor through multiple treatments at optimized time intervals was confirmed in primary human hepatocytes. Thus, combining quantitative data generation with mathematical modeling suggests that repetitive treatment with Ruxolitinib is required to effectively target excessive inflammatory responses without exceeding doses recommended by the clinical guidelines.

A high polymerized grass pollen extract is efficacious and safe in a randomized double-blind, placebo-controlled study using a novel up-dosing cluster-protocol

PubMed Central

Klimek, L; Uhlig, J; Mösges, R; Rettig, K; Pfaar, O

2014-01-01

Background Cluster immunotherapy represents an interesting alternative to conventional up-dosing schedules because it allows achieving the maintenance dose within a shorter time interval. In this study, the efficacy and safety of cluster immunotherapy with a high polymerized allergen extract of a grass/rye pollen mixture have been evaluated in a randomized, double-blind, placebo-controlled, multicenter study. Methods In total, 121 patients with allergic rhinoconjunctivitis due to grass pollen were randomized 1 : 1 to verum or placebo group. A short cluster up-dosing schedule of only 1 week was applied to achieve the maintenance dose which was administered monthly during the study period of 1 year. Total combined symptom and medication score (TCS) was defined as primary outcome parameter. Secondary outcome parameters were individual symptom and medication scores, ‘well days,’ global improvement as well as immunological effects and nasal allergen challenge. The safety profile was evaluated based on the European academy of allergy and clinical immunology grading system. Results Significant reduction in the verum compared to the placebo group (intention-to-treat, population, verum: n = 55; placebo: n = 47) was found regarding TCS (P = 0.005), rhinoconjunctivitis total symptom score (RTSS, P = 0.006), and total rescue medication score (TRMS, P = 0.002). Additionally, secondary outcomes such as ‘well days,’ nasal challenge results, and increase of specific IgG4 were in favor of the active treatment. All systemic adverse reactions (0.8% of all injections in the verum group) were of mild intensity. No severe reactions related to the study medication were observed. Conclusion Cluster immunotherapy with high polymerized grass pollen extracts resulted in significant clinical efficacy and has been shown to be a safe treatment for grass pollen-allergic patients. PMID:25130503

A randomized, open-label trial of iron isomaltoside 1000 (Monofer®) compared with iron sucrose (Venofer®) as maintenance therapy in haemodialysis patients.

PubMed

Bhandari, Sunil; Kalra, Philip A; Kothari, Jatin; Ambühl, Patrice M; Christensen, Jeppe H; Essaian, Ashot M; Thomsen, Lars L; Macdougall, Iain C; Coyne, Daniel W

2015-09-01

Iron deficiency anaemia is common in patients with chronic kidney disease, and intravenous iron is the preferred treatment for those on haemodialysis. The aim of this trial was to compare the efficacy and safety of iron isomaltoside 1000 (Monofer®) with iron sucrose (Venofer®) in haemodialysis patients. This was an open-label, randomized, multicentre, non-inferiority trial conducted in 351 haemodialysis subjects randomized 2:1 to either iron isomaltoside 1000 (Group A) or iron sucrose (Group B). Subjects in Group A were equally divided into A1 (500 mg single bolus injection) and A2 (500 mg split dose). Group B were also treated with 500 mg split dose. The primary end point was the proportion of subjects with haemoglobin (Hb) in the target range 9.5-12.5 g/dL at 6 weeks. Secondary outcome measures included haematology parameters and safety parameters. A total of 351 subjects were enrolled. Both treatments showed similar efficacy with >82% of subjects with Hb in the target range (non-inferiority, P = 0.01). Similar results were found when comparing subgroups A1 and A2 with Group B. No statistical significant change in Hb concentration was found between any of the groups. There was a significant increase in ferritin from baseline to Weeks 1, 2 and 4 in Group A compared with Group B (Weeks 1 and 2: P < 0.001; Week 4: P = 0.002). There was a significant higher increase in reticulocyte count in Group A compared with Group B at Week 1 (P < 0.001). The frequency, type and severity of adverse events were similar. Iron isomaltoside 1000 and iron sucrose have comparative efficacy in maintaining Hb concentrations in haemodialysis subjects and both preparations were well tolerated with a similar short-term safety profile. © The Author 2015. Published by Oxford University Press on behalf of ERA-EDTA.

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

PubMed

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, P<0.001), fewer weekly nitroglycerin use (WMD=-0.98, 95%CI: -1.44 to -0.52, Z=4.19, P<0.001), longer time to 1mm ST-segment depression (WMD=0.30, 95%CI: 0.17 to 0.43, Z=4.46, P<0.001), higher total work (WMD=0.82, 95%CI: 0.44 to 1.20, Z=4.22, P<0.001) and longer exercise duration at peak exercise (WMD=49.81, 95%CI: 15.04 to 84.57, Z=6.38, P<0.001) than treatment of other anti-anginal drugs for stable angina 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.

[Actions of standardized extracts of Crataegus berries on exercise tolerance and quality of life in patients with congestive heart failure].

PubMed

Rietbrock, N; Hamel, M; Hempel, B; Mitrovic, V; Schmidt, T; Wolf, G K

2001-10-01

Standardized extracts of Crataegus leaves and blossoms are said to have positive inotropic, positive dromotropic and negative bathmotropic effects. Clinical trials produce evidence for an improvement of symptoms in patients with congestive heart failure (NYHA II). In this trial the efficacy of a standardized extract of fresh Crataegus berries (Rob 10) on exercise tolerance and quality of life was studied in 88 patients. In a three-month placebo-controlled, randomized, double-blind trial these patients were treated with Rob 10 (3 x 25 drops daily). Total exercise time in bicycle ergometry was defined as primary efficacy variable, while quality of life (Minnesota Questionnaire), Dyspnea-Fatigue Index and the assessment of dyspnea by the patient on a visual analogous scale were chosen as secondary parameters. Investigations were performed after a two week placebo run-in period as well as 6 and 12 weeks after the onset of the study. Treatment with Rob 10 led to a increase of exercise time of 38.9 s vs placebo (95% confidence interval 5.7-72.1 s). Quality of life improved accordingly in favour of Rob 10. In the Minnesota Questionnaire, the total score fell by 31% (30.6 vs 44.1) under Rob 10 vs 18% (34.6 vs 42.4) under placebo. The Dyspnea-Fatigue Index demonstrated an increase of the total score of 12% (9.41 vs 8.37) vs 8% (8.92 vs 8.26) under administration of placebo. According to findings of the assessment of dyspnea by the patient, dyspnea decreased by 11% (50.5 vs 56.6 mm) vs 4% (54.8 vs 57.3 mm) under placebo. The present study proves the efficacy and safety of a standardized extract of fresh Crataegus berries (Rob 10) in patients with congestive heart failure (NYHA II) regarding the parameters evaluated.

Long-term velaglucerase alfa treatment in children with Gaucher disease type 1 naïve to enzyme replacement therapy or previously treated with imiglucerase.

PubMed

Smith, Laurie; Rhead, William; Charrow, Joel; Shankar, Suma P; Bavdekar, Ashish; Longo, Nicola; Mardach, Rebecca; Harmatz, Paul; Hangartner, Thomas; Lee, Hak-Myung; Crombez, Eric; Pastores, Gregory M

2016-02-01

Gaucher Disease type 1 (GD1) often manifests in childhood. Early treatment with enzyme replacement therapy (ERT) may prevent disease complications. We report the assessment of velaglucerase alfa ERT in pediatric GD1 patients who participated in a long-term extension study (HGT-GCB-044, ClinicalTrials.gov Identifier NCT00635427). Safety and efficacy were evaluated in pediatric patients receiving velaglucerase alfa 30-60U/kg by intravenous infusion every other week. In addition to key hematological and visceral efficacy assessments, exploratory assessments conducted specifically in pediatric patients included evaluation of height, bone age, bone marrow burden, and Tanner stage of puberty. The study included 24 pediatric patients. Fifteen patients were naïve to ERT on entry into the preceding trials TKT032 (12-month trial) or HGT-GCB-039 (9-month trial): in the preceding trials, ten of these 15 patients received velaglucerase alfa and five patients received imiglucerase ERT. Nine patients in the study were previously treated with imiglucerase for >30months and were switched to velaglucerase alfa in the preceding trial TKT034 (12-month trial). Cumulative ERT exposure in the clinical studies ranged from 2.0 to 5.8years. Three serious adverse events, including a fatal convulsion, were reported; none were deemed related to velaglucerase alfa. One patient tested positive for anti-velaglucerase alfa antibodies. An efficacy assessment at 24months showed that velaglucerase alfa had positive effects on primary hematological and visceral parameters in treatment-naïve patients, which were maintained with longer-term treatment. Disease parameters were stable in patients switched from long-term imiglucerase ERT. Exploratory results may suggest benefits of early treatment to enable normal growth in pediatric patients. The safety profile and clinical response seen in pediatric patients are consistent with results reported in adults. Copyright © 2016 Shire Development LLC. Published by Elsevier Inc. All rights reserved.

Can Reading Self-Efficacy Be Modified? A Meta-Analysis of the Impact of Interventions on Reading Self-Efficacy

ERIC Educational Resources Information Center

Unrau, Norman J.; Rueda, Robert; Son, Elena; Polanin, Joshua R.; Lundeen, Rebecca J.; Muraszewski, Alison K.

2018-01-01

Studies of interventions' impact on reading self-efficacy have been conducted since the 1980s. The purpose of this project was to conduct a systematic review of these studies because the primary studies often yielded divergent results. Included studies entailed an intervention, addressed reading specifically, and reported explicit pre- and…

An Investigation into Prospective Science Teachers' Attitudes towards Laboratory Course and Self-Efficacy Beliefs in Laboratory Use

ERIC Educational Resources Information Center

Aka, Elvan Ince

2016-01-01

The aim of the current study is to identify the attitudes towards the laboratory course and self-efficacy beliefs in the laboratory use of prospective teachers who are attending Gazi University Gazi Education Faculty Primary Education Science Teaching program, and to investigate the relationship between the attitudes and self-efficacy beliefs.…

An Examination of Middle School Students' STEM Self-Efficacy with Relation to Interest and Perceptions of STEM

ERIC Educational Resources Information Center

Brown, Patrick L.; Concannon, James P.; Marx, Donna; Donaldson, Christopher W.; Black, Alicia

2016-01-01

The purpose of this teacher research study is to ascertain students' interest in STEM and beliefs about STEM before and after STEM specific instruction, explore possible differences in STEM self-efficacy by gender, and explore differences in STEM self-efficacy by group role. Our primary data sources include a modified attitudinal survey and…

Investigating the interrelationships among conceptions of, approaches to, and self-efficacy in learning science

NASA Astrophysics Data System (ADS)

Zheng, Lanqin; Dong, Yan; Huang, Ronghuai; Chang, Chun-Yen; Bhagat, Kaushal Kumar

2018-01-01

The purpose of this study was to examine the relations between primary school students' conceptions of, approaches to, and self-efficacy in learning science in Mainland China. A total of 1049 primary school students from Mainland China participated in this study. Three instruments were adapted to measure students' conceptions of learning science, approaches to learning science, and self-efficacy. The exploratory factor analysis and confirmatory factor analysis were adopted to validate three instruments. The path analysis was employed to understand the relationships between conceptions of learning science, approaches to learning science, and self-efficacy. The findings indicated that students' lower level conceptions of learning science positively influenced their surface approaches in learning science. Higher level conceptions of learning science had a positive influence on deep approaches and a negative influence on surface approaches to learning science. Furthermore, self-efficacy was also a hierarchical construct and can be divided into the lower level and higher level. Only students' deep approaches to learning science had a positive influence on their lower and higher level of self-efficacy in learning science. The results were discussed in the context of the implications for teachers and future studies.

DEAE-Dextran in the treatment of primary hypercholesterolemia and/or hypercholesterolemia combined with hypertriglyceridemia. A multicentric randomized study on the efficacy of DEAE-Dextran compared with Cholestyramine.

PubMed

Fedele, F

2003-01-01

This study was carried out to verify the therapeutic homogeneity between DEAE-Dextran and Cholestyramine. Blood levels of total cholesterol, HDL, LDL and triglycerides were evaluated in 202 patients affected by dyslipidemia and treated with DEAD-D at 2.5 g/day or with Cholestyramine at 12 g/day for 30 days. At the end of treatment both drugs caused significant reduction of total cholesterol, LDL and triglycerides blood levels; DEAD-D was generally more effective than Cholestyramine, in particular on triglycerides values (30.6% and 13.7% of reduction respectively), and produced also a significant increase in HDL cholesterol, differently from Cholestyramine that was ineffective on this parameter.

Performance of convolutionally encoded noncoherent MFSK modem in fading channels

NASA Technical Reports Server (NTRS)

Modestino, J. W.; Mui, S. Y.

1976-01-01

The performance of a convolutionally encoded noncoherent multiple-frequency shift-keyed (MFSK) modem utilizing Viterbi maximum-likelihood decoding and operating on a fading channel is described. Both the lognormal and classical Rician fading channels are considered for both slow and time-varying channel conditions. Primary interest is in the resulting bit error rate as a function of the ratio between the energy per transmitted information bit and noise spectral density, parameterized by both the fading channel and code parameters. Fairly general upper bounds on bit error probability are provided and compared with simulation results in the two extremes of zero and infinite channel memory. The efficacy of simple block interleaving in combatting channel memory effects are thoroughly explored. Both quantized and unquantized receiver outputs are considered.

Explaining physical activity levels from a self-efficacy perspective: the physical activity counseling trial.

PubMed

Blanchard, Chris M; Fortier, Michelle; Sweet, Shane; O'Sullivan, Tracey; Hogg, William; Reid, Robert D; Sigal, Ronald J

2007-01-01

The Physical Activity Counseling (PAC) trial compared the effects of a 13-week primary care physical activity (PA) intervention that incorporated a PA counselor into a health care practice compared to a control condition on PA over a 25-week period and showed group differences in PA were present at 6 and 13 weeks. The main purpose was to examine the mediating effect of 6-week task and barrier self-efficacy on the intervention versus control group/13-week PA relationships. A secondary purpose was to determine whether task and barrier self-efficacy were significantly related to PA throughout the trial for both groups. Participants were primarily sedentary individuals who received a 2- to 4-min PA intervention from their primary care provider, after which they were randomly assigned to the intervention (n = 61) or control condition (n = 59). Self-reported PA and task (barrier) self-efficacy measures were obtained during (i.e., baseline, 6 and 13 weeks) and after (i.e., 19 and 25 weeks) the intervention in both groups. Six-week task and barrier self-efficacy had a small mediating effect. Furthermore, barrier self-efficacy had a significant relationship with PA throughout the trial, whereas the relationship between task self-efficacy and PA became significantly weaker as the trial progressed. PAC interventions among primarily sedentary individuals should be partly based on barrier and task self-efficacy. However, the stability of the task self-efficacy/PA relationship needs further examination.

An Examination of Elementary Math Anxiety, Self-Efficacy, and Academic Achievement

ERIC Educational Resources Information Center

McMillian, Kimberley Suzanne

2017-01-01

The study aims to explore the level of suburban 5th grade students' mathematics self-efficacy, math anxiety, and academic achievement, to discover the possible interconnections between these parameters. The measures used to evaluate each included the Math Anxiety Rating Scale, the Self-Efficacy Questionnaire, and the North Carolina End of Grade…

Model for the evaluation of drug-dispensing services in primary health care

PubMed Central

Sartor, Vanessa de Bona; de Freitas, Sergio Fernando Torres

2014-01-01

OBJECTIVE To develop a model for evaluating the efficacy of drug-dispensing service in primary health care. METHODS An efficacy criterion was adopted to determine the level of achievement of the service objectives. The evaluation model was developed on the basis of a literature search and discussions with experts. The applicability test of the model was conducted in 15 primary health care units in the city of Florianópolis, state of Santa Catarina, in 2010, and data were recorded in structured and pretested questionnaires. RESULTS The model developed was evaluated using five dimensions of analysis for analysis. The model was suitable for evaluating service efficacy and helped to identify the critical points of each service dimension. CONCLUSIONS Adaptations to the data collection technique may be required to adjust for the reality and needs of each situation. The evaluation of the drug-dispensing service should promote adequate access to medications supplied through the public health system. PMID:25372174

iStart smart: a primary-care based and community partnered childhood obesity management program for Chinese-American children: feasibility study.

PubMed

Chen, Jyu-Lin; Kwan, Monica; Mac, Allison; Chin, Nai-Ching; Liu, Katrina

2013-12-01

Children who are ethnic minorities, low income and live in urban neighborhoods are at higher risk for obesity. This study examined the feasibility and efficacy of a primary care-based and community partnered obesity intervention in Chinese American children. An experimental design with a historical comparison group was used to explore the feasibility of an obesity intervention for overweight Chinese American children, ages 7-12. Data were collected on weight, height, blood pressure, waist circumference, physical activity, food intake, knowledge, and self-efficacy about diet and physical activity at baseline, 2 months, and 6 months post-baseline. Significant improvements in BMI, blood pressure, and nutrition knowledge and self-efficacy were found in the intervention group. Intervention group reduced their BMI compared to the comparison group (F = 8.65, p = .004). An obesity intervention in primary care setting is feasible and demonstrates a short-term effect on weight loss in Chinese American children.

Meperidine utilization and compliance with Agency for Health Care Policy and Research guidelines in a tertiary care hospital.

PubMed

Pellegrini, J E; Paice, J; Faut-Callahan, M

1999-11-01

The Agency for Health Care Policy and Research (AHCPR) established guidelines for the use of meperidine (demerol), a common inpatient analgesic. These guidelines define standards of care for acute and chronic cancer pain management and address many of the problems with meperidine and its metabolite, normeperidine. The purpose of this study was to determine whether meperidine was prescribed in compliance with AHCPR guidelines, whether patients exhibited any adverse reactions to meperidine, and to determine the analgesic efficacy of meperidine. Three hundred inpatient charts were reviewed and identified meperidine as the primary analgesic in 157 nonobstetric inpatients. Age, sex, weight, dosing interval, route of administration, duration of meperidine use, serum chemistry values, primary diagnosis, associated medical conditions, and medications concurrently being taken with meperidine were the parameters analyzed. An interview was conducted to ascertain medical and drug history, chronicity of pain syndromes, analgesic drug history, and analgesic efficacy. A visual analog scale for pain (range = 0 to 10) and an analgesic satisfaction survey (range = 1 to 5) were used. Of 157 patients, 124 (79.8%) were in conflict with AHCPR guidelines. The most frequent conflict was found to be suboptimal dosing regimen and treatment of chronic pain. Often concurrent analgesics were given with the meperidine to achieve adequate analgesia. Higher analgesic satisfaction scores were noted when meperidine was given with concurrent analgesics. Meperidine also was administered to patients in renal failure or with medications contraindicated with meperidine use. No significant adverse effects were noted with meperidine use in this sample population other than an increased incidence of confusion in the elderly population.

Treatment of primary hyperhidrosis with tap water iontophoresis in paediatric patients: a retrospective analysis.

PubMed

Dogruk Kacar, Seval; Ozuguz, Pinar; Eroglu, Selma; Polat, Serap; Karaca, Semsettin

2014-12-01

Primary hyperhidrosis is an under-recognized condition in children and adolescents. Iontophoresis is the second line of treatment for palmoplantar hyperhidrosis following topical treatment. The studies evaluating the efficacy of iontophoresis in children are limited. We aimed to investigate the efficacy and reliability of tap water iontophoresis in children with primary hyperhidrosis. Twenty-one patients aged under 18 years, who received iontophoresis for primary palmoplantar hyperhidrosis, were included in the study. In our clinic, tap water iontophoresis was administered at regular intervals, starting with five times per week and decreased to once a week on fifth week. Then maintenance sessions once a week for 6 weeks are recommended. The presence of excessive sweating was scored by visual analogue scale (VAS): "0" as continuation of excessive sweating and "10" as the absence of excessive sweating. The demographic and clinical data were collected from files. Also, patients fulfilled a questionnaire for efficacy on follow-up visit. Nineteen patients completed the whole 21 sessions. The mean VAS score was 5.89 ± 1.49 at the end of the 15th session and 6.36 ± 2.06 at the end of the treatment. Side effects were well tolerated. Only seven patients were still free of excessive sweating on third months after treatment. The mean satisfaction score was 4.95 ± 2.38, as measured by VAS where 0 indicated dissatisfaction and 10 indicated high satisfaction. Tap water iontophoresis is an effective method of treatment for primary palmoplantar and axillary hyperhidrosis in paediatric patients. But there are still unanswered questions about the mechanism of action, ideal session intervals and protocols for maximum efficacy.

A Field Trial to Assess a Blood-Stage Malaria Vaccine

PubMed Central

Thera, Mahamadou A.; Doumbo, Ogobara K.; Coulibaly, Drissa; Laurens, Matthew B.; Ouattara, Amed; Kone, Abdoulaye K.; Guindo, Ando B.; Traore, Karim; Traore, Idrissa; Kouriba, Bourema; Diallo, Dapa A.; Diarra, Issa; Daou, Modibo; Dolo, Amagana; Tolo, Youssouf; Sissoko, Mahamadou S.; Niangaly, Amadou; Sissoko, Mady; Takala-Harrison, Shannon; Lyke, Kirsten E.; Wu, Yukun; Blackwelder, William C.; Godeaux, Olivier; Vekemans, Johan; Dubois, Marie-Claude; Ballou, W. Ripley; Cohen, Joe; Thompson, Darby; Dube, Tina; Soisson, Lorraine; Diggs, Carter L.; House, Brent; Lanar, David E.; Dutta, Sheetij; Heppner, D. Gray; Plowe, Christopher V.

2011-01-01

BACKGROUND Blood-stage malaria vaccines are intended to prevent clinical disease. The malaria vaccine FMP2.1/AS02A, a recombinant protein based on apical membrane antigen 1 (AMA1) from the 3D7 strain of Plasmodium falciparum, has previously been shown to have immunogenicity and acceptable safety in Malian adults and children. METHODS In a double-blind, randomized trial, we immunized 400 Malian children with either the malaria vaccine or a control (rabies) vaccine and followed them for 6 months. The primary end point was clinical malaria, defined as fever and at least 2500 parasites per cubic millimeter of blood. A secondary end point was clinical malaria caused by parasites with the AMA1 DNA sequence found in the vaccine strain. RESULTS The cumulative incidence of the primary end point was 48.4% in the malaria-vaccine group and 54.4% in the control group; efficacy against the primary end point was 17.4% (hazard ratio for the primary end point, 0.83; 95% confidence interval [CI], 0.63 to 1.09; P = 0.18). Efficacy against the first and subsequent episodes of clinical malaria, as defined on the basis of various parasite-density thresholds, was approximately 20%. Efficacy against clinical malaria caused by parasites with AMA1 corresponding to that of the vaccine strain was 64.3% (hazard ratio, 0.36; 95% CI, 0.08 to 0.86; P = 0.03). Local reactions and fever after vaccination were more frequent with the malaria vaccine. CONCLUSIONS On the basis of the primary end point, the malaria vaccine did not provide significant protection against clinical malaria, but on the basis of secondary results, it may have strain-specific efficacy. If this finding is confirmed, AMA1 might be useful in a multicomponent malaria vaccine. PMID:21916638

Efficacy and safety of alternating norfloxacin and rifaximin as primary prophylaxis for spontaneous bacterial peritonitis in cirrhotic ascites: a prospective randomized open-label comparative multicenter study.

PubMed

Assem, M; Elsabaawy, M; Abdelrashed, M; Elemam, S; Khodeer, S; Hamed, W; Abdelaziz, A; El-Azab, G

2016-03-01

Primary prevention of spontaneous bacterial peritonitis (SBP) is an important strategy to reduce morbidity and mortality in cirrhotic patients with ascites. Efficacy and safety of alternating rifaximin and norfloxacin as primary prophylaxis is questionable. Three hundred thirty-four cirrhotic patients with high SAAG (≥1.1) ascites, protein level in ascitic fluid less than 1.5 g/dL with advanced liver disease (Child-Pugh score >9 points with serum bilirubin level >3 mg/dL) or renal impairment (serum creatinine level >1.2 mg/dL, blood urea nitrogen level >25 mg/dL, or serum sodium level <130 mEq/L) were included in an open-label, randomized study aimed at comparing alternating use of norfloxacin and rifaximin vs. norfloxacin or rifaximin alone as primary prophylaxis for SBP. Both intention-to-treat and per-protocol efficacy analyses were done after 6 months of treatment by assessment of ascitic fluid neutrophil count. Safety analysis was done for all intention-to-treat populations. Alternating norfloxacin and rifaximin showed superior prophylaxis by intention-to-treat (74.7 vs. 56.4% vs. 68.3%, p < 0.048). Pairwise analysis showed that alternating regimen had lower probability to develop SBP when compared to a norfloxacin-based regimen in intention-to-treat (p = 0.016) and per protocol analysis (p = 0.039). There was no difference among the studied groups regarding the incidence and severity of adverse events reported. Alternating norfloxacin- and rifaximin-based primary prophylaxis for SBP showed higher efficacy with the same safety profile when compared with monotherapy of norfloxacin.

Comparison of Antimicrobial Efficacy of Diode Laser, Triphala, and Sodium Hypochlorite in Primary Root Canals: A Randomized Controlled Trial

PubMed Central

Asokan, Sharath; John, Baby; Priya, Geetha; Kumar, S

2017-01-01

Aim To evaluate the antimicrobial efficacy of diode laser, triphala, and sodium hypochlorite (NaOCl) against Enterococc-cus faecalis contaminated primary root canals. Materials and methods Forty-nine single-rooted human primary teeth were reduced up to cemento-enamel junction and biomechanically prepared. After sterilization, five teeth were selected as negative controls and remaining teeth were inoculated with E. faecalis. The teeth were then randomly divided into four groups. The first group was irradiated with diode laser, the second group was irrigated with sodium hypochlorite, and the third group with triphala solution. The fourth group served as the positive control. The antimicrobial efficacy was tested by collecting transfer fluid saline from the canals and counting the colony forming units (CFUs) of viable E. faecalis on agar plates. The Mann-Whitney test was used to analyze the results, using Statistical Package for the Social Sciences software version 19. Results The results showed that mean bacterial CFU were 8.00 ± 7.87 for laser, 58.60 ± 16.63 for triphala, and 69.80 ± 19.57 for NaOCl. Laser group showed significant reduction in the colony count compared to the other groups. Triphala group showed better antibacterial activity than NaOCl, but the difference was not statistically significant. Conclusion Laser was most effective against E. faecalis and triphala can be used as an alternative disinfectant to NaOCl in primary root canals. How to cite this article Thomas S, Asokan S, John B, Priya G, Kumar S. Comparison of Antimicrobial Efficacy of Diode Laser, Triphala, and Sodium Hypochlorite in Primary Root Canals: A Randomized Controlled Trial. Int J Clin Pediatr Dent 2017;10(1):14-17. PMID:28377648

Are primary healthcare organizational attributes associated with patient self-efficacy for managing chronic disease?

PubMed

Lemieux, Valérie; Lévesque, Jean-Frédéric; Ehrmann-Feldman, Debbie

2011-05-01

Our objective was to explore how individual and primary healthcare (PHC) organizational attributes influence patients' ability in chronic illness self-management. We conducted a cohort study, recruiting 776 adults with chronic disease from 33 PHC settings in the province of Quebec. Organizational data on the PHC clinics were obtained from a prior study. Participants were interviewed at baseline, 6 and 12 months, responding to questionnaires on self-efficacy, health status, socio-demographics, healthcare use and experience of care. Multilevel modelling showed that 52.5% of the variance in self-efficacy occurs at the level of the individual and 4.0% at the organizational level. Controlling for diagnosis, patient factors associated with self-efficacy were self-rated health (B coeff 0.76: CI 0.60; 0.92), concurrent depression (B coeff -1.41: CI 1.96; -0.86) and satisfaction with care (B coeff 0.27: CI 0.15; 0.39). None of the organizational attributes was significantly associated with self-efficacy after adjusting for lower-level variables. Patients generally reported receiving little self-management teaching across organizations.

Are Primary Healthcare Organizational Attributes Associated with Patient Self-Efficacy for Managing Chronic Disease?

PubMed Central

Lemieux, Valérie; Lévesque, Jean-Frédéric; Ehrmann-Feldman, Debbie

2011-01-01

Our objective was to explore how individual and primary healthcare (PHC) organizational attributes influence patients' ability in chronic illness self-management. We conducted a cohort study, recruiting 776 adults with chronic disease from 33 PHC settings in the province of Quebec. Organizational data on the PHC clinics were obtained from a prior study. Participants were interviewed at baseline, 6 and 12 months, responding to questionnaires on self-efficacy, health status, socio-demographics, healthcare use and experience of care. Multilevel modelling showed that 52.5% of the variance in self-efficacy occurs at the level of the individual and 4.0% at the organizational level. Controlling for diagnosis, patient factors associated with self-efficacy were self-rated health (B coeff 0.76: CI 0.60; 0.92), concurrent depression (B coeff –1.41: CI 1.96; –0.86) and satisfaction with care (B coeff 0.27: CI 0.15; 0.39). None of the organizational attributes was significantly associated with self-efficacy after adjusting for lower-level variables. Patients generally reported receiving little self-management teaching across organizations. PMID:22548102

Dose-specific effects of transcutaneous electrical nerve stimulation (TENS) on experimental pain: a systematic review.

PubMed

Claydon, Leica S; Chesterton, Linda S; Barlas, Panos; Sim, Julius

2011-09-01

To determine the hypoalgesic effects of transcutaneous electrical nerve stimulation (TENS) parameter combinations on experimental models in healthy humans. Searches were performed using the electronic databases Ovid MEDLINE, CINAHL, AMED, and Web of Science (from inception to December 2009). Manual searches of journals and reference lists of retrieved trials were also performed. Randomized controlled trials (RCTs) were included in the review if they compared the hypoalgesic effect of TENS relative with placebo and control, using an experimental pain model in healthy human participants. Two reviewers independently selected the trials, assessed their methodologic quality and extracted data. Forty-three RCTs were eligible for inclusion. A best evidence synthesis revealed: Overall "conflicting" (inconsistent findings in multiple RCTs) evidence of TENS efficacy on experimental pain irrespective of TENS parameters used. Overall intense TENS has "moderate" evidence of efficacy (1 high-quality and 2 low-quality trials). Conventional TENS has overall conflicting evidence of efficacy, this is derived from "strong" evidence of efficacy (generally consistent findings in multiple high-quality RCTs) on pressure pain but strong evidence of inefficacy on other pain models. "Limited" evidence (positive findings from 1 RCT) of hypoalgesia exists for some novel parameters. Low-intensity, low-frequency, local TENS has strong evidence of inefficacy. Inappropriate TENS (using "barely perceptible" intensities) has moderate evidence of inefficacy. The level of hypoalgesic efficacy of TENS is clearly dependent on TENS parameter combination selection (defined in terms of intensity, frequency, and stimulation site) and experimental pain model. Future clinical RCTs may consider these TENS dose responses.

High intensity focused ultrasound ablation for patients with inoperable liver cancer.

PubMed

Chen, Lianyu; Wang, Kun; Chen, Zhen; Meng, Zhiqiang; Chen, Hao; Gao, Huifeng; Wang, Peng; Zhu, Huili; Lin, Junhua; Liu, Luming

2015-01-01

To analyses the feasibility and efficacy of high intensity focused ultrasound (HIFU) treatment in patients with inoperable liver cancer. 187 patients were treated with HIFU, of all these patients 116 cases were Primary Liver Cancer (PLC) and 71 cases were Metastatic Liver Cancer (MLC). According to some parameters, such as clinical symptoms, the basis of main organs functional tests, imaging examinations, and progression-free survival (PFS) time to assess the safety and efficacy of HIFU in the treatment of liver cancer. 55 patients (29.4%) achieved CR and 73 patients (39.0%) achieved PR, 32 patients (17.1%) had responses of SD, and 27 patients (14.4%) were PD, respectively. Response rates were 90.5% (32 CR + 6 PR/42) in left lobe cancer and 64.1% (22 CR + 62 PR/131) in right lobe cancer. The median PFS for those CR case was 7 months, of PLC was 8 months, of MLC was 5 months. HIFU is effective and feasible in the treatment of liver cancer. It offer a significant noninvasive therapy for local treatment of liver cancer. For those right lobe liver cancers or with poor ultrasonic window, increasing treatment time or repeated treatment may improve the efficiency of HIFU ablation.

Transcranial direct current stimulation for acute major depressive episodes: meta-analysis of individual patient data

PubMed Central

Brunoni, André R.; Moffa, Adriano H.; Fregni, Felipe; Palm, Ulrich; Padberg, Frank; Blumberger, Daniel M.; Daskalakis, Zafiris J.; Bennabi, Djamila; Haffen, Emmanuel; Alonzo, Angelo; Loo, Colleen K.

2016-01-01

Background Transcranial direct current stimulation (tDCS) is a non-pharmacological intervention for depression. It has mixed results, possibly caused by study heterogeneity. Aims To assess tDCS efficacy and to explore individual response predictors. Method Systematic review and individual patient data meta-analysis. Results Data were gathered from six randomised sham-controlled trials, enrolling 289 patients. Active tDCS was significantly superior to sham for response (34% v. 19% respectively, odds ratio (OR) = 2.44, 95% CI 1.38–4.32, number needed to treat (NNT) = 7), remission (23.1% v. 12.7% respectively, OR = 2.38, 95% CI 1.22–4.64, NNT = 9) and depression improvement (B coefficient 0.35, 95% CI 0.12–0.57). Mixed-effects models showed that, after adjustment for other predictors and confounders, treatment-resistant depression and higher tDCS ‘doses’ were, respectively, negatively and positively associated with tDCS efficacy. Conclusions The effect size of tDCS treatment was comparable with those reported for repetitive transcranial magnetic stimulation and antidepressant drug treatment in primary care. The most important parameters for optimisation in future trials are depression refractoriness and tDCS dose. PMID:27056623

Lorcaserin Hcl for the treatment of obesity.

PubMed

Shukla, Alpana P; Kumar, Rekha B; Aronne, Louis J

2015-01-01

Obesity is a major health priority necessitating safe and effective strategies to address the obesity epidemic. Lorcaserin is a serotonergic agonist specific to the 5HT- 2C receptor approved for chronic management of obesity in patients with a BMI ≥ 30 kg/m(2) or a BMI ≥ 27 kg/m(2) with comorbidities related to obesity. In this paper, the pharmacodynamic and pharmacokinetic properties of lorcaserin are reviewed followed by a discussion of efficacy and safety data from major clinical trials. Lorcaserin is a unique highly selective serotonergic agonist designed to mitigate the risks associated with previous agents in this class. At therapeutic doses, it is well tolerated and produces modest but clinically meaningful weight loss with significant improvement in cardiometabolic parameters. Therapeutic efficacy should be assessed at 12 weeks (≥ 5% weight loss) to identify responders who will derive maximum weight loss and metabolic benefit from long-term therapy. The results of the ongoing cardiovascular outcomes trial (CAMELLIA TIMI 61) will determine the role of lorcaserin in primary prevention of diabetes in overweight/obese individuals and its use in the high-risk population of patients with established cardiovascular disease or multiple cardiovascular risk factors.

Medicinal plants for primary dysmenorrhoea: A systematic review.

PubMed

Pellow, Janice; Nienhuis, Chantelle

2018-04-01

Primary dysmenorrhoea is a common complaint experienced by many females in their reproductive years. The use of medicinal plants in the treatment of various gynaecological conditions is on the increase, despite the limited evidence available regarding efficacy and safety of their use. The aim of this systematic review was to synthesise the most recent evidence relating to the treatment of primary dysmenorrhoea with medicinal plants. A thorough database search was conducted using defined search terms, and randomised controlled trials (RCTs) published in English between 2008 and 2016, pertaining to the use of medicinal plants (single use) for the treatment of primary dysmenorrhoea, were assessed. Studies evaluating dysmenorrhoeal pain and associated symptoms as a primary or secondary outcome were considered and assessed by two reviewers independently of each other, using the JADAD scale and the Cochrane risk of bias tool,. 22 RCTs were included in the review; 9 were placebo-controlled trials and 13 were comparative studies to pharmacological treatment or nutritional supplements. Most of the evaluated medicinal plants showed evidence of efficacy in relieving menstrual pain in at least one RCT. The low or unclear quality of the majority of these studies however warrants caution in interpreting these results. This review adds to the knowledge-base on the use of these medicinal plants in the treatment of primary dysmenorrhoea. Further research is needed before definitive conclusions can be made regarding the efficacy and safety of the use of these medicinal plants. Copyright © 2018 Elsevier Ltd. All rights reserved.

Optical methods for correction of oxygen-transport characteristics of blood and their biomedical applications

NASA Astrophysics Data System (ADS)

Zalesskaya, G. A.; Akulich, N. V.; Marochkov, A. V.; Laskina, O. V.; Mit'kovskaya, N. P.

2010-07-01

We have carried out a comprehensive analysis of the spectral characteristics of blood and blood components, gas-exchange and oximetry parameters for venous and arterial blood, central hemodynamic parameters, and the results of a complete blood count and chemistry panel before and after extracorporeal UV irradiation of the blood (UBI, ultraviolet blood irradiation) or intravenous exposure of blood to low-intensity emission from an He-Ne laser (LBI, laser blood irradiation). We have demonstrated the possibility of correcting the oxygentransport characteristics of blood by laser optical methods based on photodissociation of blood oxyhemoglobin. We have shown that the therapeutic effects initiated both by UBI and LBI are based on a single mechanism: a change in the balance between production of active oxygen species and their inhibition by antioxidants. The data obtained are of interest not only for studying the primary (molecular) mechanisms of action for photohemotherapy and their effect on processes occurring in the living body, but also can provide a basis for designing next-generation laser optical instruments and for development of not yet existing methods for assessing the therapeutic efficacy of photohemotherapy.

An improved parameter estimation scheme for image modification detection based on DCT coefficient analysis.

PubMed

Yu, Liyang; Han, Qi; Niu, Xiamu; Yiu, S M; Fang, Junbin; Zhang, Ye

2016-02-01

Most of the existing image modification detection methods which are based on DCT coefficient analysis model the distribution of DCT coefficients as a mixture of a modified and an unchanged component. To separate the two components, two parameters, which are the primary quantization step, Q1, and the portion of the modified region, α, have to be estimated, and more accurate estimations of α and Q1 lead to better detection and localization results. Existing methods estimate α and Q1 in a completely blind manner, without considering the characteristics of the mixture model and the constraints to which α should conform. In this paper, we propose a more effective scheme for estimating α and Q1, based on the observations that, the curves on the surface of the likelihood function corresponding to the mixture model is largely smooth, and α can take values only in a discrete set. We conduct extensive experiments to evaluate the proposed method, and the experimental results confirm the efficacy of our method. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Developing Primary Leadership in England: Adopting an Interpretivist Perspective

ERIC Educational Resources Information Center

Zhang, Wei; Brundrett, Mark

2011-01-01

This paper aims to investigate the perceptions of primary school leaders about the efficacy of the National College programmes. The findings from six contextually different primary schools reveal that the programmes were perceived to have exerted the least influence on school leaders' personality change and pupil outcomes because many generalised…

Motives of Cheating among Secondary Students: The Role of Self-Efficacy and Peer Influence

ERIC Educational Resources Information Center

Nora, Wong Lok Yan; Zhang, Kaili Chen

2010-01-01

A survey research study was conducted with a sample of 100 secondary students from a local secondary school about the motives of cheating. The primary focus of this study was the interplay among variables of self-efficacy, peer influence and cheating. The results showed that students with low self-efficacy were more likely to cheat than those who…

Atomoxetine and Methylphenidate Treatment in Children with ADHD: The Efficacy, Tolerability and Effects on Executive Functions

ERIC Educational Resources Information Center

Yildiz, Ozlem; Sismanlar, Sahika G.; Memik, Nursu Cakin; Karakaya, Isik; Agaoglu, Belma

2011-01-01

The aim of this study was to compare the safety, efficacy, tolerability, and the effects of atomoxetine and OROS-MPH on executive functions in children with ADHD. This study was an open-label study that only included two medication groups. Children were randomized to open-label atomoxetine or OROS-MPH for 12 weeks. Primary efficacy measures were…

Self-Efficacy of Teacher Candidates for Teaching First Reading and Writing

ERIC Educational Resources Information Center

Gündogmus, Hatice Degirmenci

2018-01-01

The purpose of this study is to determine by different variables the self-efficacy of a teacher candidate for teaching first reading and writing in their 3rd and 4th year in the department of primary school teaching. In line with the purpose of the study, the self-efficacy levels of teacher candidates for teaching first reading and writing were…

Study design of J-ELD AF: A multicenter prospective cohort study to investigate the efficacy and safety of apixaban in Japanese elderly patients.

PubMed

Akao, Masaharu; Yamashita, Takeshi; Okumura, Ken

2016-12-01

Apixaban, one of the non-vitamin K antagonist oral anticoagulants, was reported to be effective and safe in stroke prevention in patients with atrial fibrillation (AF) based on the global randomized clinical trial, but data are limited on the efficacy and safety of apixaban in Japanese elderly patients. The J-ELD AF Registry is a large-scale, contemporary observational study, continuously and prospectively registering elderly Japanese patients with AF aged 75 years or older who are currently taking apixaban or the elderly who are to receive apixaban in daily clinical practice, and accumulating the outcomes during one-year follow-up period. In addition to standard baseline characteristics, prothrombin time and anti-Xa activity will be measured to investigate the biomarker characteristics. The primary efficacy endpoints will be stroke and systemic embolism, and the primary safety endpoint will be major bleeding requiring hospitalization. The secondary endpoints in this study will be all-cause death, cardiovascular death, acute myocardial infarction, and the composite of stroke/systemic embolism, cardiovascular death, and acute myocardial infarction. As a primary analysis, the primary/secondary endpoints in the enrolled patients will be totalized for the entire group, and the incidence of events will be described by age, CHADS 2 score, HAS-BLED score, and apixaban dose (5 or 2.5mg bid). The factors that independently predict the incidence of the primary/secondary endpoints will be searched for by Cox regression. The relationship between the biomarkers and the primary/secondary endpoints will also be examined in an explorative manner. This study will provide important information on the efficacy and safety of apixaban in elderly Japanese patients aged 75 years or older, and those of low-dose administration of apixaban (2.5mg bid) for which many of the Japanese elderly are indicated. Copyright © 2016 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

Clinical interrogation and application of super-selective intracranial artery infusion chemotherapy for lung cancer patients with brain metastases.

PubMed

Rong, J; Chunhua, M; Yuan, L; Ning, M; Jinduo, L; Bin, W; Liwei, S

2015-11-01

The purpose of this study was to evaluate the clinical efficacy of super-selective intracranial artery infusion chemotherapy and to determine correlated prognostic parameters for advanced lung cancer patients with brain metastases. Fifty-four lung cancer patients with brain metastasis who had no previous treatment were enrolled for the study. These patients received super-selective intracranial artery infusion chemotherapy, as well as arterial infusion chemotherapy for primary and metastatic lesions. The procedure was performed once every 4 weeks. Patients were monitored to evaluate short-term clinical outcomes 4 weeks after the first 2 treatments, and follow-up visits performed every 4 weeks after the first 4 treatments until the appearance of disease progression or intolerable toxicity. All 54 cases were treated at least 4 times. The overall response rate was 55.56% (30/54), and the disease control rate was 85.19% (46/54). The median overall survival was 7 months, with a 95% confidence interval (CI) of 5.87-8.13 months, and the median progression-free survival was 4 months, with a 95% CI of 3.20-4.80 months. The 6-month survival rate and 1-year survival rate were 81.48% (44/54) and 18.52% (10/54), respectively. Super-selective intracranial artery infusion chemotherapy provides a clinically efficacious avenue of treatment for lung cancer patients with brain metastases. Pathological classification, Karnofsky performance status, and extracranial metastases may serve as reliable prognostic parameters in determining the clinical outcomes for lung cancer patients with brain metastases.

[Crataegus Special Extract WS 1442. Assessment of objective effectiveness in patients with heart failure (NYHA II)].

PubMed

Weikl, A; Assmus, K D; Neukum-Schmidt, A; Schmitz, J; Zapfe, G; Noh, H S; Siegrist, J

1996-08-30

In a multicenter, placebo-controlled double-blind study, the efficacy of the Crataegus-Specialextrakt WS 1442 in patients with NYHA stage II cardiac insufficiency was investigated. A total of 136 patients with this diagnosis were admitted to the study and, following a 2-week run-in phase, treated with Crataegus-Specialextract or placebo over a period of 8 weeks. The primary target parameter was the change in the difference of the pressure, heart rate product (systolic blood pressure x heart rate/100) (PHRP 50 W load vs. rest) measured at the beginning and end of treatment. On the basis of this variable, a clear improvement in the performance of the heart was shown in the group receiving the test substance, while the condition of the placebo group progressively worsened. The therapeutic difference between the groups was statistically significant. The positive result for the objective efficacy parameter was confirmed by a statistically obvious superiority of Crataegus in the patient's own assessment of improvement in the main symptoms (reduced performance, shortness of breath, ankle edema etc.). In addition, active treatment led, in comparison with placebo, to a considerably better quality of life for the patient, in particular with respect to mental well-being. The tolerability of the active substance proved to be very good-as shown by comprehensive laboratory investigations and the recording of undesirable events. All in all, the results of the present clinical investigation confirm those of previous studies showing that Crataegus-Specialextrakt WS 1442 is an effective and low-risk phytotherapeutic form of treatment in patients with NYHA II cardiac insufficiency.

An open-label dose escalation study to evaluate the safety of administration of nonviral stromal cell-derived factor-1 plasmid to treat symptomatic ischemic heart failure.

PubMed

Penn, Marc S; Mendelsohn, Farrell O; Schaer, Gary L; Sherman, Warren; Farr, Maryjane; Pastore, Joseph; Rouy, Didier; Clemens, Ruth; Aras, Rahul; Losordo, Douglas W

2013-03-01

Preclinical studies indicate that adult stem cells induce tissue repair by activating endogenous stem cells through the stromal cell-derived factor-1:chemokine receptor type 4 axis. JVS-100 is a DNA plasmid encoding human stromal cell-derived factor-1. We tested in a phase 1, open-label, dose-escalation study with 12 months of follow-up in subjects with ischemic cardiomyopathy to see if JVS-100 improves clinical parameters. Seventeen subjects with ischemic cardiomyopathy, New York Heart Association class III heart failure, with an ejection fraction ≤40% on stable medical therapy, were enrolled to receive 5, 15, or 30 mg of JVS-100 via endomyocardial injection. The primary end points for safety and efficacy were at 1 and 4 months, respectively. The primary safety end point was a major adverse cardiac event. Efficacy end points were change in quality of life, New York Heart Association class, 6-minute walk distance, single photon emission computed tomography, N-terminal pro-brain natruretic peptide, and echocardiography at 4 and 12 months. The primary safety end point was met. At 4 months, all of the cohorts demonstrated improvements in 6-minute walk distance, quality of life, and New York Heart Association class. Subjects in the 15- and 30-mg dose groups exhibited improvements in 6-minute walk distance (15 mg: median [range]: 41 minutes [3-61 minutes]; 30 mg: 31 minutes [22-74 minutes]) and quality of life (15 mg: -16 points [+1 to -32 points]; 30 mg: -24 points [+17 to -38 points]) over baseline. At 12 months, improvements in symptoms were maintained. These data highlight the importance of defining the molecular mechanisms of stem cell-based tissue repair and suggest that overexpression of stromal cell-derived factor-1 via gene therapy is a strategy for improving heart failure symptoms in patients with ischemic cardiomyopathy.

An evaluation of 10 percent and 20 percent benzocaine gels in patients with acute toothaches

PubMed Central

Hersh, Elliot V.; Ciancio, Sebastian G.; Kuperstein, Arthur S.; Stoopler, Eric T.; Moore, Paul A.; Boynes, Sean G.; Levine, Steven C.; Casamassimo, Paul; Leyva, Rina; Mathew, Tanya; Shibly, Othman; Creighton, Paul; Jeffers, Gary E.; Corby, Patricia M.A.; Turetzky, Stanley N.; Papas, Athena; Wallen, Jillian; Idzik-Starr, Cynthia; Gordon, Sharon M.

2013-01-01

Background The authors evaluated the efficacy and tolerability of 10 percent and 20 percent benzocaine gels compared with those of a vehicle (placebo) gel for the temporary relief of toothache pain. They also assessed the compliance with the label dose administration directions on the part of participants with toothache pain. Methods Under double-masked conditions, 576 participants self-applied study gel to an open tooth cavity and surrounding oral tissues. Participants evaluated their pain intensity and pain relief for 120 minutes. The authors determined the amount of gel the participants applied. Results The responders’ rates (the primary efficacy parameter), defined as the percentage of participants who had an improvement in pain intensity as exhibited by a pain score reduction of at least one unit on the dental pain scale from baseline for two consecutive assessments any time between the five- and 20-minute points, were 87.3 percent, 80.7 percent and 70.4 percent, respectively, for 20 percent benzocaine gel, 10 percent benzocaine gel and vehicle gel. Both benzocaine gels were significantly (P ≤ .05) better than vehicle gel; the 20 percent benzocaine gel also was significantly (P ≤ .05) better than the 10 percent benzocaine gel. The mean amount of gel applied was 235.6 milligrams, with 88.2 percent of participants applying 400 mg or less. Conclusions Both 10 percent and 20 percent benzocaine gels were more efficacious than the vehicle gel, and the 20 percent benzocaine gel was more efficacious than the 10 percent benzocaine gel. All treatments were well tolerated by participants. Practical Implications Patients can use 10 percent and 20 percent benzocaine gels to temporarily treat toothache pain safely. PMID:23633700

Safety and efficacy of bi-annual intra-articular LBSA0103 injections in patients with knee osteoarthritis.

PubMed

Lee, Jin Kyu; Choi, Chong-Hyuk; Oh, Kwang-Jun; Kyung, Hee-Soo; Yoo, Ju-Hyung; Ha, Chul-Won; Bin, Seong-Il; Kang, Seung-Baik; Kim, Myung Ku; Lee, Ju-Hong; Lee, Myung Chul

2017-11-01

The objective of this study is to assess the safety and efficacy of repeated intra-articular injection of high molecular weight hyaluronic acid (LBSA0103) at a 26-week interval, in patients with osteoarthritis of the knee. The study was an open-label, single arm, multicentre prospective trial conducted in patients with symptomatic knee osteoarthritis. The intervention consisted of two intra-articular injections of LBSA0103, with the second injection performed 26 weeks after the first injection. The primary outcome was the incidence of adverse drug reactions related to each injection. Assessment of efficacy of repeated injections in terms of maintenance of pain relief was a secondary objective of this study. Of the 185 patients screened, 174 patients received the first injection and 153 patients received both injections of LBSA0103. Nine adverse drug reactions occurred in seven patients (4.02%) after the first injection, while only one adverse drug reaction occurred (0.65%) after the second injection. As a secondary outcome measure, the improvements in the efficacy parameters including total WOMAC score and weight-bearing pain were all significant at both week 13 and 39 compared to the baseline value (P < 0.001), and improvements after the second injection were consistent with those after the initial injection of LBSA0103 (between week 26 and week 39, P < 0.001). Repeated intra-articular injection of LBSA0103 at a 26-week interval is safe without increased risk of adverse drug reactions. Additionally, LBSA0103 is effective in reduction of osteoarthritis knee pain and in maintenance of pain reduction for a 39-week period when a second injection is administered.

Comparison of the efficacy and safety of bilastine 20 mg vs levocetirizine 5 mg for the treatment of chronic idiopathic urticaria: a multi-centre, double-blind, randomized, placebo-controlled study.

PubMed

Zuberbier, T; Oanta, A; Bogacka, E; Medina, I; Wesel, F; Uhl, P; Antépara, I; Jáuregui, I; Valiente, R

2010-04-01

Bilastine is a novel nonsedative H(1)-receptor antagonist, which may be used for the symptomatic treatment of chronic idiopathic urticaria (CU). The aim of this study was to compare the clinical efficacy and safety of bilastine 20 mg vs levocetirizine 5 mg and placebo in CU patients with moderate-to-severe symptoms. Overall 525 male and female subjects aged 18-70 years were randomized to receive bilastine 20 mg, levocetirizine 5 mg or placebo, once daily for 28 days, in double-blind manner, in 46 centres across Europe and Argentina. Patients rated symptoms of pruritus, number of wheals, and maximum size of wheals (on predefined scales) as reflective (over past 12 h) symptoms twice daily, for assessment of change from baseline in the total symptoms scores (TSS) over 28 days as the primary efficacy measure. Changes in reflective and instantaneous symptoms scores, Dermatology Life Quality Index (DLQI), and CU-associated discomfort and sleep disturbance were assessed as secondary outcomes. Safety was assessed according to adverse events, laboratory tests and electrocardiograms. Bilastine reduced patients' mean reflective and instantaneous TSS from baseline to a significantly greater degree than placebo (P < 0.001); from day 2 onwards of treatment. The DLQI, general discomfort, and sleep disruption were also improved significantly in bilastine-treated patients as compared with placebo-treated patients (P < 0.001 for all parameters). Comparison with levocetirizine indicated both treatments to be equally efficacious as well as equally safe and well tolerated as compared with placebo. Bilastine 20 mg is a novel effective and safe treatment option for the management of CU.

Treatment of carcinoma in situ of the urinary bladder with an alpha-emitter immunoconjugate targeting the epidermal growth factor receptor: a pilot study.

PubMed

Autenrieth, Michael E; Seidl, Christof; Bruchertseifer, Frank; Horn, Thomas; Kurtz, Florian; Feuerecker, Benedikt; D'Alessandria, Calogero; Pfob, Christian; Nekolla, Stephan; Apostolidis, Christos; Mirzadeh, Saed; Gschwend, Jürgen E; Schwaiger, Markus; Scheidhauer, Klemens; Morgenstern, Alfred

2018-07-01

Patients with carcinoma in situ (CIS) of the bladder refractory to bacillus Calmette-Guérin (BCG) treatment are usually treated with cystectomy. Therefore, new treatment options with preservation of the urinary bladder are needed. The objective of the study was to investigate the feasibility, safety and efficacy of a novel targeted alpha-emitter immunotherapy for CIS after BCG treatment failure. A pilot study was conducted in 12 patients (age range 64-86 years, ten men, two women) with biopsy-proven CIS of the bladder refractory to BCG treatment. The patients were treated intravesically with a single instillation (one patient was treated twice) of the alpha-emitter 213 Bi coupled to an anti-EGFR antibody (366-821 MBq). The primary aims of the study were to determine the feasibility of treatment with the 213 Bi-immunoconjugate and evaluation of adverse effects. Therapeutic efficacy was monitored by histological mapping of the urinary bladder 8 weeks after treatment and at different time points thereafter. The study proved that intravesical instillation of the 213 Bi-immunoconjugate targeting EGFR is feasible. No adverse effects were observed and all blood and urine parameters determined remained in their normal ranges. Therapeutic efficacy was considered satisfactory, in that three of the 12 patients showed no signs of CIS 44, 30 and 3 months after treatment. Intravesical instillation of 213 Bi-anti-EGFR monoclonal antibody was well tolerated and showed therapeutic efficacy. Repeated instillation and/or instillation of higher activities of the 213 Bi-immunoconjugate might lead to better therapeutic outcomes. A phase I clinical trial is planned.

Psychological and behavioral treatment of insomnia:update of the recent evidence (1998-2004).

PubMed

Morin, Charles M; Bootzin, Richard R; Buysse, Daniel J; Edinger, Jack D; Espie, Colin A; Lichstein, Kenneth L

2006-11-01

Recognition that psychological and behavioral factors play an important role in insomnia has led to increased interest in therapies targeting these factors. A review paper published in 1999 summarized the evidence regarding the efficacy of psychological and behavioral treatments for persistent insomnia. The present review provides an update of the evidence published since the original paper. As with the original paper, this review was conducted by a task force commissioned by the American Academy of Sleep Medicine in order to update its practice parameters on psychological and behavioral therapies for insomnia. A systematic review was conducted on 37 treatment studies (N = 2246 subjects/patients) published between 1998 and 2004 inclusively and identified through Psyclnfo and Medline searches. Each study was systematically reviewed with a standard coding sheet and the following information was extracted: Study design, sample (number of participants, age, gender), diagnosis, type of treatments and controls, primary and secondary outcome measures, and main findings. Criteria for inclusion of a study were as follows: (a) the main sleep diagnosis was insomnia (primary or comorbid), (b) at least 1 treatment condition was psychological or behavioral in content, (c) the study design was a randomized controlled trial, a nonrandomized group design, a clinical case series or a single subject experimental design with a minimum of 10 subjects, and (d) the study included at least 1 of the following as dependent variables: sleep onset latency, number and/or duration of awakenings, total sleep time, sleep efficiency, or sleep quality. Psychological and behavioral therapies produced reliable changes in several sleep parameters of individuals with either primary insomnia or insomnia associated with medical and psychiatric disorders. Nine studies documented the benefits of insomnia treatment in older adults or for facilitating discontinuation of medication among chronic hypnotic users. Sleep improvements achieved with treatment were well sustained over time; however, with the exception of reduced psychological symptoms/ distress, there was limited evidence that improved sleep led to clinically meaningful changes in other indices of morbidity (e.g., daytime fatigue). Five treatments met criteria for empirically-supported psychological treatments for insomnia: Stimulus control therapy, relaxation, paradoxical intention, sleep restriction, and cognitive-behavior therapy. These updated findings provide additional evidence in support of the original review's conclusions as to the efficacy and generalizability of psychological and behavioral therapies for persistent insomnia. Nonetheless, further research is needed to develop therapies that would optimize outcomes and reduce morbidity, as would studies of treatment mechanisms, mediators, and moderators of outcomes. Effectiveness studies are also needed to validate those therapies when implemented in clinical settings (primary care), by non-sleep specialists. There is also a need to disseminate more effectively the available evidence in support of psychological and behavioral interventions to health-care practitioners working on the front line.

Evaluation of photosynthetic efficacy and CO2 removal of microalgae grown in an enriched bicarbonate medium.

PubMed

Abinandan, S; Shanthakumar, S

2016-06-01

Bicarbonate species in the aqueous phase is the primary source for CO 2 for the growth of microalgae. The potential of carbon dioxide (CO 2 ) fixation by Chlorella pyrenoidosa in enriched bicarbonate medium was evaluated. In the present study, effects of parameters such as pH, sodium bicarbonate concentration and inoculum size were assessed for the removal of CO 2 by C. pyrenoidosa under mixotrophic condition. Central composite design tool from response surface methodology was used to validate statistical methods in order to study the influence of these parameters. The obtained results reveal that the maximum removal of CO 2 was attained at pH 8 with sodium bicarbonate concentration of 3.33 g/l, and inoculum size of 30 %. The experimental results were statistically significant with R 2 value of 0.9527 and 0.960 for CO 2 removal and accumulation of chlorophyll content, respectively. Among the various interactions, interactive effects between the parameters pH and inoculum size was statistically significant (P < 0.05) for CO 2 removal and chlorophyll accumulation. Based on the studies, the application of C. pyrenoidosa as a potential source for carbon dioxide removal at alkaline pH from bicarbonate source is highlighted.

[Utility of treatment with atorvastatin 40 mg plus ezetimibe 10 mg versus atorvastatin 80 mg in reducing the levels of LDL cholesterol in patients with ischaemic stroke or transient ischaemic attack].

PubMed

Palacio, Enrique; Viadero-Cervera, Raquel; Revilla, Marián; Larrosa-Campo, Davinia; Acha-Salazar, Olga; Novo-Robledo, Francisco; Oterino, Agustín

2016-03-01

After an ischaemic stroke, to reduce LDL cholesterol (LDLc) levels decreases the risk of recurrence. The risk of recurrence is lower with more intense reductions in LDLc levels. To evaluate the efficacy and security of atorvastatin 40 mg plus ezetimibe 10 mg after ischaemic stroke or transient ischaemic attack (TIA). We retrospectively evaluated stroke or TIA patients admitted to our hospital who received atorvastatin 40 mg plus ezetimibe 10 mg (n = 34) or atorvastatin 80 mg (n = 52) at discharge. We analyzed changes in lipid parameters and established as a primary outcome LDLc <= 70 mg/dL and/or reduction in LDLc >= 50%. Furthermore, safety parameters were assessed. Predictors associated with primary outcome achievement were treatment with atorvastatin 40 mg plus ezetimibe 10 mg (odds ratio: 11.94; 95% CI: 2.82-50.64; p = 0.001) and male (odds ratio: 4.76; 95% CI: 1.35-16.67; p = 0.02). Treatment with atorvastatin 40 mg plus ezetimibe 10 mg achieved significantly greater reductions in LDLc (p < 0.001), total cholesterol (p < 0.001) and non-HDLc (p < 0.001). Both treatments were safe and well tolerated, with a low number of secondary effects. Compared with atorvastatin 80 mg, atorvastatin 40 mg plus ezetimibe 10 mg increases the likelihood of achieving LDLc goals after ischaemic stroke or transient ischaemic attack. Both treatments were safe and well tolerated.

Efficacy and safety of testosterone replacement gel for treating hypogonadism in men: Phase III open-label studies.

PubMed

Belkoff, L; Brock, G; Carrara, D; Neijber, A; Ando, M; Mitchel, J

2018-02-01

Efficacy and safety of testosterone gel 2% (TG) were evaluated in two phase 3, open-labelled, single-arm, multicentre studies (000023 and extension study 000077). Hypogonadal men having serum testosterone levels <300 ng/dl at two consecutive measurements were included. Study duration was 9 months (000023: 3 months; 000077: 6 months). Starting dose of TG (46 mg) was applied on upper arm/shoulder. The primary endpoint (000023) was responder rate (subjects with average 24-hour serum testosterone concentration 300-1050 ng/dl on Day 90). Study 000077 evaluated the safety of TG in patients rolling over from study 000023 over a period of 6 months. Of 180 subjects in 000023, 172 completed and 145 rolled over to 000077, with 127 completers. The responder rate was 85.5%. Fewer subjects in 000077 (12.7%) versus 000023 (31.8%) had maximum testosterone concentration (C max ) >1500 ng/dl, with no significant safety concerns. Significant improvements in sexual function and quality of life were noted in both studies. Subjects experienced few skin reactions without notable increases in prostate-specific antigen and haematocrit levels. TG was efficacious with an acceptable safety profile. C max >1500 ng/dl did not exhibit distinct impact on safety parameters. However, further optimisation of titration schema to reduce C max is warranted while maintaining the average steady state total testosterone concentration. © 2017 Blackwell Verlag GmbH.

Efficacy of Corneal Collagen Cross-Linking for Treatment of Keratoconus: A Meta-Analysis of Randomized Controlled Trials

PubMed Central

Lin, Xiaoti

2015-01-01

Objective To evaluate the efficacy of corneal collagen cross-linking (CXL) for the treatment of keratoconus. Methods We performed a literature search for randomized controlled trials that assessed the effect of CXL in slowing progression of keratoconus. The primary outcome measures included changes of topographic parameters, visual acuity, and refraction. Efficacy estimates were evaluated by weighted mean difference (WMD) and 95% confidence interval (CI) for absolute changes of the interested outcomes. Results Significant decrease in mean keratometry value, maximum keratometry value and minimum keratometry value were demonstrated in the CXL group compared with the control group (WMD = -1.65; 95% CI: -2.51 to -0.80; P < 0.00001; WMD = -2.05; 95% CI: -3.10 to -1.00; P < 0.00001; WMD = -1.94; 95% CI: -2.63 to -1.26; P < 0.00001; respectively). Best spectacle-corrected visual acuity improved significantly in CXL group (WMD = -0.10; 95% CI: -0.15 to -0.05; P < 0.00001), whereas uncorrected visual acuity did not differ statistically. Manifest cylinder error decreased significantly in patients undergoing CXL procedure compared with control patients in sensitivity analysis (WMD = -0.388; 95% CI: -0.757 to -0. 019; P = 0.04). The changes in central corneal thickness and intraocular pressure were not statistically significant. Conclusion CXL may be an effective option in stabilizing keratoconus. Further long-term follow-up studies will be necessary to assess the persistence of CXL. PMID:25985208

[Trimigren in stopping migraine attacks: an open prospective multicenter comparative study of rectal suppository and tablet forms of sumatriptan].

PubMed

Azimova, Iu E; Tabeeva, G R

2009-01-01

Efficacy and safety of sumatriptan in rectal suppository (50 mg) and tablet forms (50 mg) in stopping migraine attacks has been studied in 80 patients with migraine with or without aura. Dynamics of migraine pain intensity measured with the VAS 30 min, 1, 2, 6 and 24 h after the first dose of drug was a primary index of efficacy. Secondary indices were the VAS intensity of nausea, vomiting, photophobia, phonophobia, duration of each migraine attack, quality of life parameters of a patient during the migraine attack assessed with the 24-hour questionnaire, severity of migraine course on the MIDAS, percentage of patients with complete regression of migraine pain, at least in 2 out of 3 attacks. To assess drug safety, any adverse effects, data of instrumental methods (clinical and biochemical blood tests, clinical urine test), EKG were taken into account. Rectal suppository had the more rapid effect on headache reduction compared to tablets. Changes of intensity of concomitant symptoms (nausea, vomiting, photophobia, phonophobia) as well as other secondary indices of drug efficacy were similar in both groups. In the group treated with rectal suppository, 9 (22.5%) patients had 12 adverse effects. In the group treated with tablets, 22 adverse effects were noted in 15 (37.5%) patients. Adverse effects related to the cardio-vascular system were observed less often in the group treated with rectal suppository (6.6 and 32%, respectively, p=0,004).

Experimental-clinical study on the effects of hydromassage with Thermae Oasis's salsobromoiodine water in chronic venous stasis disease of the lower extremities.

PubMed

Ippolito, E; De Luca, S; Sommaruga, S; Grassellino, V; Nappi, G

2008-08-01

The aim of this study was to evaluate the efficacy of thermal therapy, in particular hydromassage therapy with the ''Ca' Rossa'' salsobromoiodic water of the Thermae Oasis (Ferrara, Italy), in patients with chronic venous insufficiency (CVI) of the inferior limbs. Fourty-four patients with primary varices of the legs were enrolled. The anamnestic symptomatologic indicators of disease were: pain, perception of heaviness or paresthesias, nocturnal cramps, ''restless leg'' syndrome, pruritus. The symptoms were evaluated for both intensity and frequency. An additional clinical indicator was the centimetric measurement of the leg diameters at 3 levels: supramalleolar, mid-calf and mid-thigh. The patients were subdivided in two groups: patients submitted to a cycle of hydromassage with salsobromoiodic water and patients treated with compressive elastic stocking (12 mmHg). At the end of the treatment cycle, symptomatologic and clinical data were reassessed, in addition to morphological and velocimetric parameters related to the function of the peripheral vascular system. The results showed in Group A (thermal water hydromassage) an improved reduction of subjective and objective symptoms as compared to the control Group B, demonstrating a superior efficacy of thermal therapy. The efficacy of hydromassage therapy is due not only to the favourable action of hydrostatic pressure upon venous flow of the inferior limbs, but also to the peculiar chemical and physical characteristics of the thermal water utilized in this study. The elevated osmotic power of hydromassage is responsible for the significant intrinsic antiedematous properties.

Prospective, multicentre, randomized, double-blind study of the efficacy of escitalopram versus citalopram in outpatient treatment of major depressive disorder.

PubMed

Moore, Nicholas; Verdoux, Hélène; Fantino, Bruno

2005-05-01

Pre-clinical studies, active-control clinical trials and meta-analyses indicate that escitalopram (S-citalopram) might be more effective than citalopram, the racemic mixture of S- and R-citalopram. The present study aimed to confirm the superior efficacy of escitalopram over citalopram. A double-blind, randomized clinical trial was performed in which general practitioners and psychiatrists compared fixed doses of escitalopram (20 mg/day) with citalopram (40 mg/day) over 8 weeks in outpatients with major depressive disorder (MDD) [baseline Montgomery-Asberg Depression Rating Scale (MADRS) score > or =30]. Primary efficacy parameter was change from baseline to last assessment in the MADRS total score. Out of 138 (aged 44.1+/-10.9 years; initial MADRS score 36.3+/-4.8) and 142 (aged 46.2+/-11.1 years; initial MADRS score 35.7+/-4.4) evaluable patients who were randomized to escitalopram and citalopram, respectively, six and 15 withdrew prematurely (P=0.05). The MADRS score decreased more in the escitalopram than in the citalopram arm (-22.4+/-12.9 versus -20.3+/-12.7; P<0.05). There were more treatment responders with escitalopram (76.1%) than with citalopram (61.3%, P<0.01). Adjusted remitter rates were 56.1% and 43.6%, respectively (P<0.05). Tolerability was similar in both groups. This randomized double-blind trial confirms that escitalopram has a superior effect to citalopram in MDD.

Comparison of the Efficacy of Dry Needling and High-Power Pain Threshold Ultrasound Therapy with Clinical Status and Sonoelastography in Myofascial Pain Syndrome.

PubMed

Aridici, Rifat; Yetisgin, Alparslan; Boyaci, Ahmet; Tutoglu, Ahmet; Bozdogan, Erol; Sen Dokumaci, Dilek; Kilicaslan, Nihat; Boyaci, Nurefsan

2016-10-01

The aim of this study was to compare the therapeutic efficacy of high-power pain threshold (HPPT) ultrasound therapy applied to the trigger points and dry needling (DN) in myofascial pain syndrome. Sixty-one patients were randomly assigned to an HPPT (n = 30) and dry needling (n = 31) groups. The primary outcome measures were the Visual Analog Scale (VAS) and Neck Pain and Disability Scale (NPDS), both at 1 week and 4 weeks after treatment. The secondary outcome measures were the number of painful trigger points, range of the tragus-acromioclavicular joint, the Short Form-36, the Beck Depression Inventory, the Beck Anxiety Inventory, and sonoelastographic tests after a 1-week treatment. More improvement was seen in anxiety in the HPPT group (P < 0.05). However, no significant differences were found between the groups with regard to other parameters (P > 0.05). A decrease in tissue stiffness was only seen in the HPPT group (P < 0.05). Significant posttreatment improvements were seen on all clinical scales in both groups (P < 0.05). After a treatment period of 4 weeks, a significant improvement was also observed on the visual analog scale and NPDS (P < 0.05). Our study favors the efficacy of both treatment methods in myofascial pain syndrome. Although a significant decrease was shown in tissue stiffness with HPPT, neither of these treatments had an apparent superiority.

Cancer survivors' self-efficacy to self-manage in the year following primary treatment.

PubMed

Foster, C; Breckons, M; Cotterell, P; Barbosa, D; Calman, L; Corner, J; Fenlon, D; Foster, R; Grimmett, C; Richardson, A; Smith, P W

2015-03-01

Cancer survivors are increasingly expected to manage the consequences of cancer and its treatment for themselves. There is evidence that self-efficacy is important for successful self-management and that this can be enhanced with support. The purpose of this study was to assess self-efficacy to manage problems in the year following primary treatment. This cross-sectional online survey included cancer survivors who had completed their treatment within the past 12 months. Self-efficacy was assessed and variables expected to be associated with self-efficacy were measured using validated scales including quality of life, well-being, illness perceptions, depression and social support. One hundred eighty-two respondents (mean age 50; 81% female) completed the survey. They had been treated for a range of cancers; most commonly breast (45%). Self-efficacy scores varied between individuals and according to the illness-related task to be managed. Respondents were least confident in managing fatigue and most confident in accessing information about their cancer. Individuals most likely to report low self-efficacy were women, those experiencing higher levels of pain and/or depression, lower well-being scores, lower socio-economic status, low levels of social support, or a more negative perception of cancer. Self-efficacy to self-manage problems faced as a consequence of cancer and its treatment can vary widely in the year following treatment. Fatigue may be particularly difficult to manage. Variations in self-efficacy highlight the importance of assessing specific problems faced and people's confidence to manage them in order to tailor appropriate self-management support.

A pilot single centre, double blind, placebo controlled, randomized, parallel study of Calmagen® dermaceutical cream and lotion for the topical treatment of tinea and onychomycosis.

PubMed

Parekh, Manoj; Ramaiah, Girisha; Pashilkar, Prachi; Ramanujam, Ranjani; Johnston, Peter; Ilag, Leodevico L

2017-09-18

Most of the current anti-fungal treatments are chemical-based, fungistatic, have low efficacy in the treatment of tinea and toxicity concerns, while onychomycosis remains recalcitrant to most antifungal therapies. The study aimed to establish the fungicidal, efficacy and safety profile of Calmagen® dermaceutical cream and lotion containing AMYCOT® as a topical treatment in patients with severe to very severe presentations of fungal skin (tinea) and nail infections (onychomycosis). A randomized, placebo-controlled, double blind, parallel, single centre study was conducted on 28 subjects with severe to very severe tinea or onychomycosis. All patients were randomized in a ratio of 1:1 for treatment or placebo group. Subjects in the treatment arm received Calmagen® cream or lotion, while subjects in the placebo arm received a similar inert topical preparation. Tinea subjects were treated with cream for four weeks, while onychomycosis subjects were treated with lotion for 12 weeks. Mycological cure, the primary endpoint, was assessed by three parameters: KOH (potassium hydroxide) smear, fungal culture and live spore count. Clinical cure was defined as Investigator Global Assessment (IGA) response of 'cleared' or 'excellent'. All three parameters constituting mycological cure were confirmed in 92.8% (13/14) of subjects in the treatment arm, while all 14 subjects in the placebo arm remained positive for KOH smear. Calmagen® cream and lotion treatment showed a significant improvement in all three parameters: KOH smear, (95% CI (Calmagen): 79.4, 100.0; 95% CI (placebo): 0.0, 0.0; p < 0.0001); fungal culture (95% CI (Calmagen); 100.0, 100.0; 95% CI (Placebo): 17.0, 100.0; p < 0.0019); and live spore count (95% CI (Calmagen): 100.0, 100.0; 95% CI (Placebo): 17.0, 100.0; p < 0.0019). Clinical cure was achieved in all subjects in the treatment arm while none in the placebo arm were clinically cured. No treatment-related adverse effects were observed in either group. The Calmagen® cream and lotion containing AMYCOT® represent a potentially safe and efficacious natural alternative in the treatment of Tinea and onychomycosis. This trial has been registered with the clinical trial registry-India (CTRI; registration number: CTRI/2012/03/002522 ).

A randomized, single-blind trial of 5% minoxidil foam once daily versus 2% minoxidil solution twice daily in the treatment of androgenetic alopecia in women.

PubMed

Blume-Peytavi, Ulrike; Hillmann, Kathrin; Dietz, Ekkehart; Canfield, Douglas; Garcia Bartels, Natalie

2011-12-01

Although twice-daily application of propylene glycol-containing 2% minoxidil topical solution (MTS) stimulates new hair growth, higher concentrations of minoxidil in a once-daily, propylene glycol-free formulation may improve efficacy and reduce unpleasant side effects. We sought to compare the efficacy, safety, and acceptability and to show noninferiority of once-daily 5% minoxidil topical foam (MTF) with twice-daily 2% MTS in women with androgenetic alopecia. A total of 113 women with androgenetic alopecia were randomized to 24 weeks of treatment with 5% MTF or 2% MTS. The primary efficacy parameter was change from baseline in nonvellus target area hair count at week 24. Secondary end points included change in nonvellus target area hair width, overall efficacy by global photographic review as assessed by treatment-blinded evaluators and the subject herself, adverse events, and participants' assessment of product aesthetics. After 24 weeks, women randomized to 5% MTF once daily showed noninferior target area hair count and target area hair width and experienced greater, but nonsignificant, improvements in target area hair count, target area hair width, and overall efficacy by global photographic review than those randomized to 2% MTS used twice daily. 5% MTF was significantly superior to 2% MTS in participants' agreement with "the treatment does not interfere with styling my hair" (P = .002). Women randomized to 5% MTF experienced significantly lower rates of local intolerance (P = .046) especially in pruritus and dandruff compared with 2% MTS. Because of differences in the formulations tested, study participants were not blinded to treatment. Once-daily 5% MTF is noninferior and as effective for stimulating hair growth as twice-daily 2% MTS in women with androgenetic alopecia and is associated with several aesthetic and practical advantages. Copyright © 2010 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

Effect of a plaster containing DHEP and heparin in acute ankle sprains with oedema: a randomized, double-blind, placebo-controlled, clinical study.

PubMed

Coudreuse, J-M; de Vathaire, F

2010-09-01

Ankle sprains are the most frequent injuries in sport and daily life, and are usually treated with anti-inflammatory drugs or compounds that have an effect on microcirculation. The efficacy and tolerability of a novel plaster containing both diclofenac epolamine (DHEP) and heparin in the treatment of acute painful ankle sprains with oedema was investigated in a randomized, double-blind, placebo-controlled study. This study, carried out in 32 French medical centres, enrolled 233 patients (148 male and 86 female, aged 18-65 years) with an ankle sprain that had occurred within the previous 48 hours. Patients were treated once daily with DHEP heparin or placebo plaster for 7 days. Reduction in ankle joint swelling measured by submalleolar circumference was the primary efficacy endpoint; secondary endpoints were pain (at rest, in active mobilization, by passive stretch and by pressure), functional disability and global judgement of efficacy and tolerability. DHEP heparin-treated patients experienced a significantly greater reduction in joint swelling compared with placebo (p = 0.005). The reduction in pain was also in favour of DHEP heparin patients, with significantly lower pain in DHEP heparin-treated than placebo-treated patients within 3 hours of the first application (p < 0.05). Only two patients in the DHEP heparin plaster group and six in the placebo group experienced minor adverse events, all of which resolved spontaneously. By design, the study was limited to a placebo-controlled comparison, and there was no test for possible selection bias (subsequently ruled out by choice of efficacy parameters and measures) that may have resulted in a baseline imbalance between patient groups. Results confirm the efficacy of DHEP heparin plaster compared with placebo for the treatment of painful ankle sprain with oedema. Prompt control of pain and oedema may shorten the time to initiation of a rehabilitation programme, thus reducing the risk of ankle disability recurrence and the development of chronic injury.

Articaine (4%) with epinephrine (1:100,000 or 1:200,000) in intraosseous injections in symptomatic irreversible pulpitis of mandibular molars: anesthetic efficacy and cardiovascular effects.

PubMed

Pereira, Leandro Augusto Pinto; Groppo, Francisco Carlos; Bergamaschi, Cristiane de Cássia; Meechan, John Gerard; Ramacciato, Juliana Cama; Motta, Rogério Heládio Lopes; Ranali, José

2013-08-01

The aim of this study was to compare the cardiovascular effects and the anesthetic efficacy of intraosseous injections of 4% articaine with 1:100,000 epinephrine (EPI100) or 4% articaine with 1:200,000 epinephrine (EPI200). In this prospective, randomized, double-blind study, 0.9 mL EPI100 and EPI200 solutions were administered for endodontic treatment of mandibular molars with symptomatic irreversible pulpitis in 60 patients. The anesthetic success and pain during anesthesia were evaluated by visual analog scale. The cardiovascular parameters evaluated were heart rate, diastolic/systolic blood pressure, pulse oximetry, and electrocardiogram changes. Both solutions provided high anesthetic efficacy (96.8% and 93.1% for EPI100 and EPI200, respectively; P > .05), and the cardiovascular parameters showed minimal incidences of significant differences throughout the clinical procedure. The epinephrine concentration did not affect the efficacy of 4% articaine, and both solutions produced a high success level of pulpal anesthesia. Intraosseous delivery by slow speed of injection did not induce significant clinical changes in cardiovascular parameters. Copyright © 2013 Elsevier Inc. All rights reserved.

Study protocol for a pragmatic randomised controlled trial evaluating efficacy of a smoking cessation e-‘Tabac Info Service’: ee-TIS trial

PubMed Central

Cambon, L; Bergman, P; Le Faou, Al; Vincent, I; Le Maitre, B; Pasquereau, A; Arwidson, P; Thomas, D; Alla, F

2017-01-01

Introduction A French national smoking cessation service, Tabac Info Service, has been developed to provide an adapted quitline and a web and mobile application involving personalised contacts (eg, questionnaires, advice, activities, messages) to support smoking cessation. This paper presents the study protocol of the evaluation of the application (e-intervention Tabac Info Service (e-TIS)). The primary objective is to assess the efficacy of e-TIS. The secondary objectives are to (1) describe efficacy variations with regard to users' characteristics, (2) analyse mechanisms and contextual conditions of e-TIS efficacy. Methods and analyses The study design is a two-arm pragmatic randomised controlled trial including a process evaluation with at least 3000 participants randomised to the intervention or to the control arm (current practices). Inclusion criteria are: aged 18 years or over, current smoker, having completed the online consent forms, possessing a mobile phone with android or apple systems and using mobile applications, wanting to stop smoking sooner or later. The primary outcome is the point prevalence abstinence of 7 days at 6 months later. Data will be analysed in intention to treat (primary) and per protocol analyses. A logistic regression will be carried out to estimate an OR (95% CI) for efficacy. A multivariate multilevel analysis will explore the influence on results of patients' characteristics (sex, age, education and socioprofessional levels, dependency, motivation, quit experiences) and contextual factors, conditions of use, behaviour change techniques. Ethics and dissemination The study protocol was reviewed by the ethical and deontological institutional review board of the French Institute for Public Health Surveillance on 18 April 2016. The findings of this study will allow us to characterise the efficacy of e-TIS and conditions of its efficacy. These findings will be disseminated through peer-reviewed articles. Trial registration number NCT02841683; Pre-results. PMID:28237958

Embellishment of Student Leadership in Learning Multiplication at Primary Level

ERIC Educational Resources Information Center

Singaravelu, G.

2006-01-01

The present study enlightens the efficacy of Student Leadership method in learning Multiplication in Mathematics at primary level. Single group experimental method was adopted for the study. Forty learners studying in Standard III in Panchayat union primary School, Muthupettai in South Tamil Nadu, India have been selected as sample for the study.…

The CoRe of the Matter: Developing Primary Teachers' Professional Knowledge in Science

ERIC Educational Resources Information Center

Hume, Anne

2016-01-01

In an educational landscape of primary teachers' underdeveloped professional knowledge and low feelings of self-efficacy around science teaching, the prospects for science losing status in the primary school curriculum seems grim. This paper reports positive findings from a New Zealand research project designed to support and enhance primary…

Developing school-pharmacist partnerships to enhance correct medication use and pain medication literacy in Taiwan.

PubMed

Chang, Fong-Ching; Chi, Hsueh-Yun; Huang, Li-Jung; Lee, Chun-Hsien; Yang, Jyun-Long; Yeh, Ming-Kung

2015-01-01

To evaluate the effectiveness of the health promoting school (HPS)-community pharmacist partnership program that promotes students' correct medication use and enhances pain medication literacy in Taiwan. Pre- and post-studies and intervention/comparison group comparisons. Primary and middle schools, along with their communities, in Taiwan. In 2013, baseline and follow-up self-administered, online surveys were received from 5,373 students enrolled in intervention primary and middle schools and from 4,643 students enrolled in comparison primary and middle schools. The level of medication literacy, including correct medication use knowledge, self-efficacy, and skills. The development and implementation of the HPS-community pharmacist partnership program in primary and middle schools significantly enhanced students' knowledge, self-efficacy, and skills in correct medication use and pain medication literacy (P <0.001). The HPS-community pharmacist partnership had a positive impact on enhancing correct medication use and pain medication literacy in Taiwan.

Does transcranial electrical stimulation enhance corticospinal excitability of the motor cortex in healthy individuals? A systematic review and meta-analysis.

PubMed

Dissanayaka, Thusharika; Zoghi, Maryam; Farrell, Michael; Egan, Gary F; Jaberzadeh, Shapour

2017-08-01

Numerous studies have explored the effects of transcranial electrical stimulation (tES) - including anodal transcranial direct current stimulation (a-tDCS), cathodal transcranial direct current stimulation (c-tDCS), transcranial alternative current stimulation (tACS), transcranial random noise stimulation (tRNS) and transcranial pulsed current stimulation (tPCS) - on corticospinal excitability (CSE) in healthy populations. However, the efficacy of these techniques and their optimal parameters for producing robust results has not been studied. Thus, the aim of this systematic review was to consolidate current knowledge about the effects of various parameters of a-tDCS, c-tDCS, tACS, tRNS and tPCS on the CSE of the primary motor cortex (M1) in healthy people. Leading electronic databases were searched for relevant studies published between January 1990 and February 2017; 126 articles were identified, and their results were extracted and analysed using RevMan software. The meta-analysis showed that a-tDCS application on the dominant side significantly increases CSE (P < 0.01) and that the efficacy of a-tDCS is dependent on current density and duration of application. Similar results were obtained for stimulation of M1 on the non-dominant side (P = 0.003). The effects of a-tDCS reduce significantly after 24 h (P = 0.006). Meta-analysis also revealed significant reduction in CSE following c-tDCS (P < 0.001) and significant increases after tRNS (P = 0.03) and tPCS (P = 0.01). However, tACS effects on CSE were only significant when the stimulation frequency was ≥140 Hz. This review provides evidence that tES has substantial effects on CSE in healthy individuals for a range of stimulus parameters. © 2017 Federation of European Neuroscience Societies and John Wiley & Sons Ltd.

Bioequivalence of HX575 (recombinant human epoetin alfa) and a comparator epoetin alfa after multiple intravenous administrations: an open-label randomised controlled trial.

PubMed

Sörgel, Fritz; Thyroff-Friesinger, Ursula; Vetter, Andrea; Vens-Cappell, Bernhard; Kinzig, Martina

2009-05-22

HX575 is a human recombinant epoetin alfa that was approved for use in Europe in 2007 under the European Medicines Agency biosimilar approval pathway. Therefore, in order to demonstrate the bioequivalence of HX575 to an existing epoetin alfa, the pharmacokinetic and pharmacodynamic response to steady state circulating concentrations of HX575 and a comparator epoetin alfa were compared following multiple intravenous administrations. An open, randomised, parallel group study was conducted in 80 healthy adult males. Subjects were randomised to multiple intravenous doses of 100 IU/kg body weight of HX575 or of the comparator epoetin alfa three-times-weekly for four weeks. Serum epoetin concentrations were measured using an enzyme-linked immunosorbent assay and pharmacokinetic parameters for the two treatments were compared. The time course and area under the effect curve ratio of haematological characteristics were used as surrogate parameters for efficacy evaluation. The haematological profiles of both treatments were similar, as determined from their population mean curves and the AUECHb ratio and 90% confidence interval (99.9% [98.5-101.2%]), the primary pharmacodynamic endpoint of this study. The pharmacokinetic parameters after the treatments showed minor differences after single dosing, but not at steady state doses. After multiple doses, HX575 was bioequivalent to the comparator with respect to the rate and extent of exposure of exogenous epoetin (AUCtau ratio and 90% confidence interval: 89.2% [82.5-96.2%]). Study medication was well tolerated with no clinically relevant differences between safety profiles of the treatments. Anti-epoetin antibodies were not detected. HX575 and the comparator epoetin alfa were bioequivalent at steady state circulating drug concentrations with respect to their pharmacokinetic profile and pharmacodynamic action. This supports the conclusion that HX575 and the comparator epoetin alfa, when administered intraveneously, will be equally efficacious and may be interchangeable as therapy.

A Leadless Intracardiac Transcatheter Pacing System.

PubMed

Reynolds, Dwight; Duray, Gabor Z; Omar, Razali; Soejima, Kyoko; Neuzil, Petr; Zhang, Shu; Narasimhan, Calambur; Steinwender, Clemens; Brugada, Josep; Lloyd, Michael; Roberts, Paul R; Sagi, Venkata; Hummel, John; Bongiorni, Maria Grazia; Knops, Reinoud E; Ellis, Christopher R; Gornick, Charles C; Bernabei, Matthew A; Laager, Verla; Stromberg, Kurt; Williams, Eric R; Hudnall, J Harrison; Ritter, Philippe

2016-02-11

A leadless intracardiac transcatheter pacing system has been designed to avoid the need for a pacemaker pocket and transvenous lead. In a prospective multicenter study without controls, a transcatheter pacemaker was implanted in patients who had guideline-based indications for ventricular pacing. The analysis of the primary end points began when 300 patients reached 6 months of follow-up. The primary safety end point was freedom from system-related or procedure-related major complications. The primary efficacy end point was the percentage of patients with low and stable pacing capture thresholds at 6 months (≤2.0 V at a pulse width of 0.24 msec and an increase of ≤1.5 V from the time of implantation). The safety and efficacy end points were evaluated against performance goals (based on historical data) of 83% and 80%, respectively. We also performed a post hoc analysis in which the rates of major complications were compared with those in a control cohort of 2667 patients with transvenous pacemakers from six previously published studies. The device was successfully implanted in 719 of 725 patients (99.2%). The Kaplan-Meier estimate of the rate of the primary safety end point was 96.0% (95% confidence interval [CI], 93.9 to 97.3; P<0.001 for the comparison with the safety performance goal of 83%); there were 28 major complications in 25 of 725 patients, and no dislodgements. The rate of the primary efficacy end point was 98.3% (95% CI, 96.1 to 99.5; P<0.001 for the comparison with the efficacy performance goal of 80%) among 292 of 297 patients with paired 6-month data. Although there were 28 major complications in 25 patients, patients with transcatheter pacemakers had significantly fewer major complications than did the control patients (hazard ratio, 0.49; 95% CI, 0.33 to 0.75; P=0.001). In this historical comparison study, the transcatheter pacemaker met the prespecified safety and efficacy goals; it had a safety profile similar to that of a transvenous system while providing low and stable pacing thresholds. (Funded by Medtronic; Micra Transcatheter Pacing Study ClinicalTrials.gov number, NCT02004873.).

School and University Partnerships: The Role of Teacher Education Institutions and Primary Schools in the Development of Preservice Teachers' Science Teaching Efficacy

ERIC Educational Resources Information Center

Petersen, Jacinta E.; Treagust, David F.

2014-01-01

Science in the Australian primary school context is in a state of renewal with the recent implementation of the Australian Curriculum: Science. Despite this curriculum renewal, the results of primary students in science have remained static. Science in Australia has been identified as one of the least taught subjects in the primary school…

A comparison of the efficacy of organic and mixed-organic polymers with polyaluminium chloride in chemically assisted primary sedimentation (CAPS).

PubMed

De Feo, G; Galasso, M; Landi, R; Donnarumma, A; De Gisi, S

2013-01-01

CAPS is the acronym for chemically assisted primary sedimentation, which consists of adding chemicals to raw urban wastewater to increase the efficacy of coagulation, flocculation and sedimentation. The principal benefits of CAPS are: upgrading of urban wastewater treatment plants; increasing efficacy of primary sedimentation; and the major production of energy from the anaerobic digestion of primary sludge. Metal coagulants are usually used because they are both effective and cheap, but they can cause damage to the biological processes of anaerobic digestion. Generally, biodegradable compounds do not have these drawbacks, but they are comparatively more expensive. Both metal coagulants and biodegradable compounds have preferential and penalizing properties in terms of CAPS application. The problem can be solved by means of a multi-criteria analysis. For this purpose, a series of tests was performed in order to compare the efficacy of several organic and mixed-organic polymers with that of polyaluminium chloride (PACl) under specific conditions. The multi-criteria analysis was carried out coupling the simple additive weighting method with the paired comparison technique as a tool to evaluate the criteria priorities. Five criteria with the following priorities were used: chemical oxygen demand (COD) removal > turbidity, SV60 > coagulant dose, and coagulant cost. The PACl was the best alternative in 70% of the cases. The CAPS process using PACl made it possible to obtain an average COD removal of 68% compared with 38% obtained, on average, with natural sedimentation and 61% obtained, on average, with the best PACl alternatives (cationic polyacrylamide, natural cationic polymer, dicyandiamide resin).

Safety and efficacy of antibiotics compared with appendicectomy for treatment of uncomplicated acute appendicitis: meta-analysis of randomised controlled trials

PubMed Central

Varadhan, Krishna K; Neal, Keith R

2012-01-01

Objective To compare the safety and efficacy of antibiotic treatment versus appendicectomy for the primary treatment of uncomplicated acute appendicitis. Design Meta-analysis of randomised controlled trials. Population Randomised controlled trials of adult patients presenting with uncomplicated acute appendicitis, diagnosed by haematological and radiological investigations. Interventions Antibiotic treatment versus appendicectomy. Outcome measures The primary outcome measure was complications. The secondary outcome measures were efficacy of treatment, length of stay, and incidence of complicated appendicitis and readmissions. Results Four randomised controlled trials with a total of 900 patients (470 antibiotic treatment, 430 appendicectomy) met the inclusion criteria. Antibiotic treatment was associated with a 63% (277/438) success rate at one year. Meta-analysis of complications showed a relative risk reduction of 31% for antibiotic treatment compared with appendicectomy (risk ratio (Mantel-Haenszel, fixed) 0.69 (95% confidence interval 0.54 to 0.89); I2=0%; P=0.004). A secondary analysis, excluding the study with crossover of patients between the two interventions after randomisation, showed a significant relative risk reduction of 39% for antibiotic therapy (risk ratio 0.61 (0.40 to 0.92); I2=0%; P=0.02). Of the 65 (20%) patients who had appendicectomy after readmission, nine had perforated appendicitis and four had gangrenous appendicitis. No significant differences were seen for treatment efficacy, length of stay, or risk of developing complicated appendicitis. Conclusion Antibiotics are both effective and safe as primary treatment for patients with uncomplicated acute appendicitis. Initial antibiotic treatment merits consideration as a primary treatment option for early uncomplicated appendicitis. PMID:22491789

High-wattage pulsed irradiation of linearly polarized near-infrared light to stellate ganglion area for burning mouth syndrome.

PubMed

Momota, Yukihiro; Kani, Koichi; Takano, Hideyuki; Matsumoto, Fumihiro; Aota, Keiko; Takegawa, Daisuke; Yamanoi, Tomoko; Kondo, Chika; Tomioka, Shigemasa; Azuma, Masayuki

2014-01-01

The purpose of this study was to apply high-wattage pulsed irradiation of linearly polarized near-infrared light to the stellate ganglion area for burning mouth syndrome (BMS) and to assess the efficacy of the stellate ganglion area irradiation (SGR) on BMS using differential time-/frequency-domain parameters (D parameters). Three patients with BMS received high-wattage pulsed SGR; the response to SGR was evaluated by visual analogue scale (VAS) representing the intensity of glossalgia and D parameters used in heart rate variability analysis. High-wattage pulsed SGR significantly decreased the mean value of VAS in all cases without any adverse event such as thermal injury. D parameters mostly correlated with clinical condition of BMS. High-wattage pulsed SGR was safe and effective for the treatment of BMS; D parameters are useful for assessing efficacy of SGR on BMS.

Affective Aspects of Language Learning: Beliefs, Attitudes, Efficacy

ERIC Educational Resources Information Center

Oliver, Rhonda; Purdie, Nola; Rochecouste, Judith

2005-01-01

The focus of this study is the relationship between language attitude, beliefs, efficacy, English language competence, and language achievement. Two hundred and eighty-five students from five metropolitan primary schools in Western Australia completed a specially designed questionnaire based on the Attitude/Motivation Test Battery (Gardner,…

CT-Guided, Ethanol Sympatholysis for Primary Axillary–Palmar Hyperhidrosis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Tsitskari, Maria, E-mail: mariadote@hotmail.com; Friehs, Gerhard, E-mail: gerhardf@amc.com.cy; Zerris, Vassilis, E-mail: vassilisz@amc.com.cy

PurposePrimary hyperhidrosis is an excessive sweating due to an overactive sympathetic system. Our objective was to test the feasibility and provide early data on the safety/efficacy of CT-guided sympatholysis, for primary hyperhidrosis.Materials and MethodsNine consecutive patients with axillary–palmar hyperhidrosis were treated between 2013 and 2015. CT-guided sympathetic block was performed in the outpatients at T-2, T-3, and T-4, bilaterally using alcohol under local anesthesia. Immediate postprocedure CT was obtained to assess the complications as per Common Terminology Criteria for Adverse Events, version 4. Technical success and clinical success were recorded. Primary and secondary efficacy were assessed by phone and clinicalmore » visits; mean follow-up was 12 months (6–26 months). Descriptive statistics was used to report the outcomes.ResultsOne procedure was aborted due to eyelid ptosis after lidocaine injection. All other eight patients (5:3, F:M) (median age 32) had immediate cessation of sweating. Two major complications (pneumothorax, one requiring a chest tube) occurred. Two patients recurred with unilateral and one with bilateral symptoms. One of the unilateral recurrence and the bilateral recurrence patients was retreated successfully. Median follow-up was 1 year. No cases of Horner’s or compensatory hyperhidrosis were observed.ConclusionsCT-guided EtOH sympatholysis for axillary/palmar primary hyperhidrosis is feasible. Technical failure rate was 11 %. Primary and secondary efficacy are 75 and 94 %, respectively, to a median follow-up of 1 year. Risk profile appears favorable. Despite a small sample size, results confirm feasibility and encourage a larger study.« less

CT-Guided, Ethanol Sympatholysis for Primary Axillary-Palmar Hyperhidrosis.

PubMed

Tsitskari, Maria; Friehs, Gerhard; Zerris, Vassilis; Georgiades, Christos

2016-12-01

Primary hyperhidrosis is an excessive sweating due to an overactive sympathetic system. Our objective was to test the feasibility and provide early data on the safety/efficacy of CT-guided sympatholysis, for primary hyperhidrosis. Nine consecutive patients with axillary-palmar hyperhidrosis were treated between 2013 and 2015. CT-guided sympathetic block was performed in the outpatients at T-2, T-3, and T-4, bilaterally using alcohol under local anesthesia. Immediate postprocedure CT was obtained to assess the complications as per Common Terminology Criteria for Adverse Events, version 4. Technical success and clinical success were recorded. Primary and secondary efficacy were assessed by phone and clinical visits; mean follow-up was 12 months (6-26 months). Descriptive statistics was used to report the outcomes. One procedure was aborted due to eyelid ptosis after lidocaine injection. All other eight patients (5:3, F:M) (median age 32) had immediate cessation of sweating. Two major complications (pneumothorax, one requiring a chest tube) occurred. Two patients recurred with unilateral and one with bilateral symptoms. One of the unilateral recurrence and the bilateral recurrence patients was retreated successfully. Median follow-up was 1 year. No cases of Horner's or compensatory hyperhidrosis were observed. CT-guided EtOH sympatholysis for axillary/palmar primary hyperhidrosis is feasible. Technical failure rate was 11 %. Primary and secondary efficacy are 75 and 94 %, respectively, to a median follow-up of 1 year. Risk profile appears favorable. Despite a small sample size, results confirm feasibility and encourage a larger study.

Employment status, employment functioning, and barriers to employment among VA primary care patients.

PubMed

Zivin, Kara; Yosef, Matheos; Levine, Debra S; Abraham, Kristen M; Miller, Erin M; Henry, Jennifer; Nelson, C Beau; Pfeiffer, Paul N; Sripada, Rebecca K; Harrod, Molly; Valenstein, Marcia

2016-03-15

Prior research found lower employment rates among working-aged patients who use the VA than among non-Veterans or Veterans who do not use the VA, with the lowest reported employment rates among VA patients with mental disorders. This study assessed employment status, employment functioning, and barriers to employment among VA patients treated in primary care settings, and examined how depression and anxiety were associated with these outcomes. The sample included 287 VA patients treated in primary care in a large Midwestern VA Medical Center. Bivariate and multivariable analyses were conducted examining associations between socio-demographic and clinical predictors of six employment domains, including: employment status, job search self-efficacy, work performance, concerns about job loss among employed Veterans, and employment barriers and likelihood of job seeking among not employed Veterans. 54% of respondents were employed, 36% were not employed, and 10% were economically inactive. In adjusted analyses, participants with depression or anxiety (43%) were less likely to be employed, had lower job search self-efficacy, had lower levels of work performance, and reported more employment barriers. Depression and anxiety were not associated with perceived likelihood of job loss among employed or likelihood of job seeking among not employed. Single VA primary care clinic; cross-sectional study. Employment rates are low among working-aged VA primary care patients, particularly those with mental health conditions. Offering primary care interventions to patients that address mental health issues, job search self-efficacy, and work performance may be important in improving health, work, and economic outcomes. Published by Elsevier B.V.

A complex behavioural change intervention to reduce the risk of diabetes and prediabetes in the pre-conception period in Malaysia: study protocol for a randomised controlled trial.

PubMed

Skau, Jutta K H; Nordin, Awatef Binti Amer; Cheah, Julius C H; Ali, Roslinah; Zainal, Ramli; Aris, Tahir; Ali, Zainudin Mohd; Matzen, Priya; Biesma, Regien; Aagaard-Hansen, Jens; Hanson, Mark A; Norris, Shane A

2016-04-27

Over the past two decades, the population of Malaysia has grown rapidly and the prevalence of diabetes mellitus in Malaysia has dramatically increased, along with the frequency of obesity, hyperlipidaemia and hypertension. Early-life influences play an important role in the development of non-communicable diseases. Indeed, maternal lifestyle and conditions such as gestational diabetes mellitus or obesity can affect the risk of diabetes in the next generation. Lifestyle changes can help to prevent the development of type 2 diabetes mellitus. This is a protocol for an unblinded, community-based, randomised controlled trial in two arms to evaluate the efficacy of a complex behavioural change intervention, combining motivational interviewing provided by a community health promoter and access to a habit formation mobile application, among young Malaysian women and their spouses prior to pregnancy. Eligible subjects will be Malaysian women in the age group 20 to 39 years, who are nulliparous, not diagnosed with diabetes and own a smartphone. With an alpha-value of 0.05, a statistical power of 90 %, 264 subjects will need to complete the study. Subjects with their spouses will be randomised to either the intervention or the control arm for an 8-month period. The primary endpoint is change in waist circumference from baseline to end of intervention period and secondary endpoints are changes in anthropometric parameters, biochemical parameters, change in health literacy level, dietary habits, physical activity and stress level. Primary endpoint and the continuous secondary endpoints will be analysed in a linear regression model, whereas secondary endpoints on an ordinal scale will be analysed by using the chi-squared test. A multivariate linear model for the primary endpoint will be undertaken to account for potential confounders. This study has been approved by the Medical Research and Ethics Committee of the Ministry of Health Malaysia (protocol number: NMRR-14-904-21963) on 21 September 2015. This study protocol describes the first community-based randomised controlled trial, to examine the efficacy of a complex intervention in improving the pre-pregnancy health of young Malaysian women and their spouses. Results from this trial will contribute to improve policy and practices regarding complex behavioural change interventions to prevent diabetes in the pre-conception period in Malaysia and other low- and middle-income country settings. This trial is registered with ClinicalTrials.gov (www.clinicaltrials.gov) on 30 November 2015, Identifier: NCT02617693 .

The primary prevention of alcohol problems: a critical review of the research literature.

PubMed

Moskowitz, J M

1989-01-01

The research evaluating the effects of programs and policies in reducing the incidence of alcohol problems is critically reviewed. Four types of preventive interventions are examined including: (1) policies affecting the physical, economic and social availability of alcohol (e.g., minimum legal drinking age, price and advertising of alcohol), (2) formal social controls on alcohol-related behavior (e.g., drinking-driving laws), (3) primary prevention programs (e.g., school-based alcohol education), and (4) environmental safety measures (e.g., automobile airbags). The research generally supports the efficacy of three alcohol-specific policies: raising the minimum legal drinking age to 21, increasing alcohol taxes and increasing the enforcement of drinking-driving laws. Also, research suggests that various environmental safety measures reduce the incidence of alcohol-related trauma. In contrast, little evidence currently exists to support the efficacy of primary prevention programs. However, a systems perspective of prevention suggests that prevention programs may become more efficacious after widespread adoption of prevention policies that lead to shifts in social norms regarding use of beverage alcohol.

School Self-Concept in Adolescents With Chronic Pain.

PubMed

Logan, Deirdre E; Gray, Laura S; Iversen, Christina N; Kim, Susan

2017-09-01

This study investigated school self-efficacy and sense of school membership (collectively "school self-concept") as potential influences on impaired school function among adolescents with chronic pain, including comparison of adolescents with primary pain to those with disease-based pain and pain-free peers. In all, 264 adolescents (12-17 years old) with primary pain conditions, juvenile idiopathic arthritis, or no pain completed measures of functional disability, school functioning, pain characteristics, and school self-concept, the Self-Efficacy Questionnaire for School Situations (SEQ-SS), and Psychological Sense of School Membership (PSSM). Both the SEQ-SS and PSSM demonstrated reliability and some validity, with the SEQ-SS more strongly supported. As a group, adolescents with primary pain conditions reported poorer school self-concept. School self-efficacy, but not school belongingness, predicted school functioning later in the school year. School self-concept, especially as assessed with the SEQ-SS, is relevant and important to assess when addressing school functioning in youth with chronic pain. © The Author 2017. Published by Oxford University Press on behalf of the Society of Pediatric Psychology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

Tofacitinib, an oral Janus kinase inhibitor, as monotherapy or with background methotrexate, in Japanese patients with rheumatoid arthritis: an open-label, long-term extension study.

PubMed

Yamanaka, Hisashi; Tanaka, Yoshiya; Takeuchi, Tsutomu; Sugiyama, Naonobu; Yuasa, Hirotoshi; Toyoizumi, Shigeyuki; Morishima, Yosuke; Hirose, Tomohiro; Zwillich, Samuel

2016-01-28

Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis. Here, tofacitinib safety and efficacy data from a long-term extension study in Japanese patients are presented. Study A3921041 was a multi-centre, open-label, long-term extension study that included Japanese patients who had participated in a prior Phase 2 or Phase 3 study of tofacitinib as monotherapy or with background methotrexate. Patients received tofacitinib 5 mg twice daily (BID) or tofacitinib 10 mg BID. Dose adjustment of tofacitinib during treatment period, and concomitant usage of disease-modifying antirheumatic drugs including methotrexate after week 12 were permitted. Primary endpoints were adverse events, laboratory parameters and vital signs. Secondary efficacy endpoints included American College of Rheumatology (ACR)20/50/70 response rates, Disease Activity Score (DAS)28-4(erythrocyte sedimentation rate (ESR))<2.6 response rate (DAS-defined remission) and Health Assessment Questionnaire-Disability Index (HAQ-DI) score. Safety and efficacy data were assessed throughout the study. A total of 486 patients were recruited and treated (1439.9 patient-years of exposure). 308 patients completed the study. Median (range) duration of treatment in this extension study was 1185 (5-2016) days. 476 patients (97.9 %) experienced adverse events; the majority of which (97.8 %) were of mild or moderate severity. The two most common treatment-emergent adverse events were nasopharyngitis (n = 293, 60.3 %) and herpes zoster (n = 94, 19.3 %). For all tofacitinib-treated patients, the incidence rate (patients with events per 100 patient-years) was 10.7 for serious adverse events, 3.3 for serious infections, 7.4 for herpes zoster (serious and non-serious) and 1.2 for malignancies (excluding non-melanoma skin cancer). Mean changes from baseline (start of the index study) in laboratory parameters were consistent with those seen in previously reported studies of tofacitinib. ACR20/50/70 response rates, DAS-defined remission rates and HAQ-DI scores were sustained through to study completion. Tofacitinib (with or without background methotrexate) demonstrated a stable safety profile and sustained efficacy in Japanese patients with active rheumatoid arthritis. The risk of herpes zoster appears to be higher in Japanese patients treated with tofacitinib than in the global population. Clinicaltrials.gov NCT00661661 . Registered 7 February 2008.

Evaluation of calibration efficacy under different levels of uncertainty

DOE PAGES

Heo, Yeonsook; Graziano, Diane J.; Guzowski, Leah; ...

2014-06-10

This study examines how calibration performs under different levels of uncertainty in model input data. It specifically assesses the efficacy of Bayesian calibration to enhance the reliability of EnergyPlus model predictions. A Bayesian approach can be used to update uncertain values of parameters, given measured energy-use data, and to quantify the associated uncertainty.We assess the efficacy of Bayesian calibration under a controlled virtual-reality setup, which enables rigorous validation of the accuracy of calibration results in terms of both calibrated parameter values and model predictions. Case studies demonstrate the performance of Bayesian calibration of base models developed from audit data withmore » differing levels of detail in building design, usage, and operation.« less

Efficacy and safety of crizotinib among Chinese EML4-ALK-positive, advanced-stage non-small cell lung cancer patients.

PubMed

Cao, Yabing; Xiao, Guangli; Qiu, Xibin; Ye, Sheng; Lin, Tongyu

2014-01-01

We report the efficacy and safety of crizotinib treatment among Chinese patients with advanced-stage NSCLC. We retrospectively analyzed patients with EML4-ALK positive advanced NSCLC who were treated with crizotinib from May 2012 to Aug 2013. Baseline clinical parameters, treatment protocol, response to therapy and survival were noted. The primary goal was to evaluate the efficacy of crizotinib in patients who were previously treated patients or who had poor ECOG performance status (PS). Forty patients were evaluable for safety and efficacy. Median age was 43 years, 100% had adenocarcinoma and stage IV disease, and 42.5% were female. Six patients received frontline treatment with crizotinib, 17 patients had 1 prior treatment, and 17 patients had more than 2 lines of prior treatment. Patients received a median of 5 cycles of treatment (range 1-15 cycles). After the first cycle, 92.5% (37/40) patients archived partial remission (PR). At the end of the follow-up period, the overall PR rate was 70% (28/40), and progression of disease (PD) occurred in 30% of patients (12/40). The median PFS was 28 weeks (95% CI 15.4 to 40.5 weeks), and median OS was 40 weeks (95% CI 38.6 to 49.3 weeks). The most frequent treatment-related AEs were vomiting (47.5%), vision disorder (27.5%) and increased ALT/AST (42%); most toxicities were Grade 1/2. Observed treatment-related Grade 3/4 AEs included increased ALT/AST (10%) and vomiting (5%). The EML4-ALK fusion rate and number of prior chemotherapy cycles did not appear to significantly affect the efficacy of crizotinib. However, PS 0-2 patients had improved PFS (50 weeks vs. 24 weeks, p = 0.015). Crizotinib was safe, well-tolerated, and effective in Chinese patients with pre-treated ALK-rearranged NSCLC. QOL was improved and PS appears to have an effect on the efficacy of crizotinib, but prior treatment and ALK fusion rate do not.

Scientific Inquiry Self-Efficacy and Computer Game Self-Efficacy as Predictors and Outcomes of Middle School Boys' and Girls' Performance in a Science Assessment in a Virtual Environment

ERIC Educational Resources Information Center

Bergey, Bradley W.; Ketelhut, Diane Jass; Liang, Senfeng; Natarajan, Uma; Karakus, Melissa

2015-01-01

The primary aim of the study was to examine whether performance on a science assessment in an immersive virtual environment was associated with changes in scientific inquiry self-efficacy. A secondary aim of the study was to examine whether performance on the science assessment was equitable for students with different levels of computer game…

The Study of Foreign Language Teachers-- Teacher Efficacy and Native Speakership

ERIC Educational Resources Information Center

Liaw, En-Chong

2009-01-01

This study aims at examining the differences between native and nonnative foreign language teachers at a major northeast university. The primary areas of investigation are "teacher efficacy" and "teacher perceptions of language teaching." The results of this study suggested that both nativeness and wide repertoire of teaching…

The Relationship between Bureaucratic School Structures and Teacher Self-Efficacy

ERIC Educational Resources Information Center

Kilinç, Ali Çagatay; Kosar, Serkan; Er, Emre; Ögdem, Zeki

2016-01-01

The purpose of this study was to examine the relationship between bureaucratic school structures and teachers' self-efficacy. Participants included 252 teachers from 15 primary schools in Ankara, Turkey. Mean, standard deviation, correlation, and regression analyses were conducted. Results indicated that bureaucratic school structures and teacher…

Self-Efficacy and Music Teaching: Five Narratives

ERIC Educational Resources Information Center

de Vries, Peter

2017-01-01

This article examines generalist primary (elementary) school teachers' self-efficacy in teaching music. Five teachers, each with five years teaching experience, were interviewed for the study. Using this interview data narratives were constructed for each of the five teachers. These narratives focused on what factors contributed to the level of…

Efficacy of a School-Based Primary Prevention Program for Coping with Exposure to Political Violence

ERIC Educational Resources Information Center

Slone, Michelle; Shoshani, Anat

2008-01-01

A paradigm conceptualizing resilience as factors moderating between political violence exposure and psychological distress administered in a 7-year research project yielded a profile of factors promoting Israeli children's coping in conflict conditions. Three factors--social support mobilization, self-efficacy, and meaning attribution--were…

The effect of the inductive electric field on ion poloidal rotation in all collisionality regimes for the primary ions in tokamaks

DOE Office of Scientific and Technical Information (OSTI.GOV)

Pan Chengkang; Wang Shaojie; Institute of Plasma Physics, Chinese Academy of Sciences, Hefei, 230031

2007-11-15

The expression for the poloidal rotation velocity of the primary ions that is caused by the parallel inductive electric field in tokamaks and valid in all collisionality regimes is derived via the Hirshman-Sigmar moment approach. Also the expression of the collisional impurity ions poloidal rotation velocity that is caused by the parallel inductive electric field in tokamaks is derived. The poloidal rotation velocities of the primary ions and the impurity ions are sensitive to the primary ion collisionality parameter and the impurity strength parameter. The poloidal rotation velocities of the primary ions and the impurity ions decrease with the primarymore » ion collisionality parameter and decrease with the impurity strength parameter.« less

Quasi-Experimental Evaluation of a National Primary School HIV Intervention in Kenya

ERIC Educational Resources Information Center

Maticka-Tyndale, Eleanor; Wildish, Janet; Gichuru, Mary

2007-01-01

This study examined the impact of a primary-school HIV education initiative on the knowledge, self-efficacy and sexual and condom use activities of upper primary-school pupils in Kenya. A quasi-experimental mixed qualitative-quantitative pre- and 18-month post-design using 40 intervention and 40 matched control schools demonstrated significant…

Addressing Adult Innumeracy via an Interventionist Approach to Mathematics Aversion in Pre-Service Primary Teachers

ERIC Educational Resources Information Center

Klinger, Christopher M.

2011-01-01

Student primary teachers tend to have pervasive and frequently severe negative attitudes, low mathematics self-efficacy beliefs, and anxiety of mathematics that are more extreme than those of any other undergraduate student group. If unaddressed, such mathematics aversion will be carried into primary school classrooms, presenting a tangible and…

The Gendered, Hierarchical Construction of Teacher Identities: Exploring the Male Primary School Teacher Voice in Hong Kong

ERIC Educational Resources Information Center

Trent, John

2015-01-01

In response to the perceived "feminisation" of primary school teaching, educational authorities in many countries have implemented policies designed to encourage more men to take up teaching positions in primary schools. While challenges to the efficacy of such policies have emerged in the literature, limited attention has been given to…

An Integrative Review of Self-Efficacy Measurement Instruments in Youth with Type 1 Diabetes (T1DM)

PubMed Central

Rasbach, Lisa; Jenkins, Carolyn; Laffel, Lori

2014-01-01

Purpose The purpose of this study is to assess the extant literature on instruments used to measure self-efficacy in youth with type 1 diabetes (T1DM) and their caregivers and to critically evaluate these measurements. Methods An integrative review (2003–2013) was conducted searching PsycINFO, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and U.S. National Library of Medicine PubMed service (PubMed) databases using key words diabetes, type 1 diabetes, and self-efficacy. The authors reviewed the resulting294 references for inclusion criteria of (a) sample of youth with T1DM or sample of caregivers of youth with T1DM, (b) description of the self-efficacy instrument as primary research, and (c) the instrument measured self-efficacy specifically related to diabetes management. Forty-five articles out of the initial 294 met criteria. Results Of the 45 articles, 10 different self-efficacy instruments were identified. The primary theoretical framework used was Bandura’s social cognitive theory and model of self-efficacy. Most participants were white middle class T1DM youth. Evaluations to assess validity often were not reported; however, a majority of studies reported high internal consistency of the instruments. Conclusions Sample homogeneity could limit the applicability of results to certain patient populations. Further psychometric analysis, including validity assessments, should be conducted in more diverse samples. Development of valid and reliable instruments for measuring self-efficacy that are sensitive to change across a wider caregiver base over time is necessary. While this review examined reliable and valid instruments used in research, future opportunities include evaluation of measuring self-efficacy in T1DM youth exposed to recent advances in diabetes management technologies. PMID:25216655

Bias in reporting of randomised clinical trials in oncology.

PubMed

Vera-Badillo, Francisco E; Napoleone, Marc; Krzyzanowska, Monika K; Alibhai, Shabbir M H; Chan, An-Wen; Ocana, Alberto; Seruga, Bostjan; Templeton, Arnoud J; Amir, Eitan; Tannock, Ian F

2016-07-01

Bias in reporting efficacy and toxicity in clinical trials may impact treatment decisions. Here, we report quality of reporting of efficacy and of toxicity in articles describing randomised controlled trials (RCTs) of cancer therapy and the association between biased reporting and study results, funding and financial relationships of the authors with the sponsor. We reviewed articles published from July 2010 to December 2012 in six high-impact journals reporting RCTs of systemic treatment for cancer. Bias in reporting of the primary end-point and toxicity were assessed. Associations between biased reporting and study results, funding source and financial ties of the author with the funding source were evaluated using logistic regression. Two hundred articles were identified. Among 107 RCTs where there was no statistically significant difference in the primary end-point between the two arms, 50 (47%) reports used biased reporting in the abstract of the paper to imply benefit of the experimental treatment. Toxicity was not reported in the abstract in 18.5% of the studies and this was associated with a positive primary end-point. Source of funding and financial ties were not associated with biased reporting. Bias in reporting of efficacy outcomes is common for studies with a negative primary end-point and can lead to off-label misuse of experimental therapies, if they are approved for other indications. Toxicity is under-reported, especially for studies with a positive primary end-point, leading to a biased view of the safety of new treatments. Copyright © 2016 Elsevier Ltd. All rights reserved.

Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence.

PubMed

Le Noury, Joanna; Nardo, John M; Healy, David; Jureidini, Jon; Raven, Melissa; Tufanaru, Catalin; Abi-Jaoude, Elia

2015-09-16

To reanalyse SmithKline Beecham's Study 329 (published by Keller and colleagues in 2001), the primary objective of which was to compare the efficacy and safety of paroxetine and imipramine with placebo in the treatment of adolescents with unipolar major depression. The reanalysis under the restoring invisible and abandoned trials (RIAT) initiative was done to see whether access to and reanalysis of a full dataset from a randomised controlled trial would have clinically relevant implications for evidence based medicine. Double blind randomised placebo controlled trial. 12 North American academic psychiatry centres, from 20 April 1994 to 15 February 1998. 275 adolescents with major depression of at least eight weeks in duration. Exclusion criteria included a range of comorbid psychiatric and medical disorders and suicidality. Participants were randomised to eight weeks double blind treatment with paroxetine (20-40 mg), imipramine (200-300 mg), or placebo. The prespecified primary efficacy variables were change from baseline to the end of the eight week acute treatment phase in total Hamilton depression scale (HAM-D) score and the proportion of responders (HAM-D score ≤8 or ≥50% reduction in baseline HAM-D) at acute endpoint. Prespecified secondary outcomes were changes from baseline to endpoint in depression items in K-SADS-L, clinical global impression, autonomous functioning checklist, self-perception profile, and sickness impact scale; predictors of response; and number of patients who relapse during the maintenance phase. Adverse experiences were to be compared primarily by using descriptive statistics. No coding dictionary was prespecified. The efficacy of paroxetine and imipramine was not statistically or clinically significantly different from placebo for any prespecified primary or secondary efficacy outcome. HAM-D scores decreased by 10.7 (least squares mean) (95% confidence interval 9.1 to 12.3), 9.0 (7.4 to 10.5), and 9.1 (7.5 to 10.7) points, respectively, for the paroxetine, imipramine and placebo groups (P=0.20). There were clinically significant increases in harms, including suicidal ideation and behaviour and other serious adverse events in the paroxetine group and cardiovascular problems in the imipramine group. Neither paroxetine nor high dose imipramine showed efficacy for major depression in adolescents, and there was an increase in harms with both drugs. Access to primary data from trials has important implications for both clinical practice and research, including that published conclusions about efficacy and safety should not be read as authoritative. The reanalysis of Study 329 illustrates the necessity of making primary trial data and protocols available to increase the rigour of the evidence base. © Le Noury et al 2015.

Update on the Management of Diarrhea-Predominant Irritable Bowel Syndrome: Focus on Rifaximin and Eluxadoline.

PubMed

Rivkin, Anastasia; Rybalov, Sergey

2016-03-01

Diarrhea-predominant irritable bowel syndrome (IBS-D) is one of the most common diagnoses made by gastroenterologists. Current pharmacologic treatments for IBS-D include fiber supplements, antidiarrheal over-the-counter medications, probiotics, antispasmodics, antidepressants, and a 5-hydroxytryptophan 3 receptor antagonist. All of these options have limited efficacy in managing IBS-D. Rifaximin, a nonabsorbable antibiotic, has been evaluated in patients with IBS-D. In two randomized, double-blind, placebo-controlled phase III trials evaluating rifaximin 550 mg by mouth 3 times/day for 14 days, the primary efficacy end point was achieved by 9% more patients randomized to the rifaximin group compared with placebo (40.7% vs 31.7%, p<0.001, number needed to treat ~11). The primary efficacy end point was defined as the proportion of patients having adequate relief of global IBS symptoms for at least 2 of the 4 weeks during the primary follow-up period (weeks 3-6). In the phase III trial examining the efficacy and safety of repeated courses of rifaximin in patients who responded to the initial 2-week course, rifaximin given for up to two additional courses provided a statistically significant incremental benefit (33% vs 25%, p=0.02). Eluxadoline is a gut-targeting μ and κ opioid receptor agonist and a δ opioid receptor antagonist. The dual mechanism of eluxadoline may explain the antidiarrheal and abdominal pain-modulating properties and lack of profound constipation. In two identically designed randomized, double-blind, placebo-controlled phase III studies, 10.3% more patients in an eluxadoline 100 mg by mouth twice/day group met the primary efficacy end point during the follow-up 1-12 week period compared with placebo (p<0.001). The primary efficacy end point was a composite response, defined as improvement in worst abdominal pain and stool consistency at the same time on most (50% or more) days during the follow-up period. This review evaluates evidence for the use of rifaximin and eluxadoline in patients with IBS-D. Rifaximin provides an additional modality for the management of IBS-D patients; it has mild to moderate efficacy similar to other currently available treatment options. Rifaximin is relatively safe, lacks significant drug-drug interactions, and can be used for up to two additional retreatment courses. This may make rifaximin a possible initial or second-line treatment option. Eluxadoline can also offer relief to patients with IBS-D. While effective, because of several limitations, including drug-drug interactions and drug disease contraindications, as well as current lack of clinical experience, it may be tried as a second- or third-line agent. © 2016 Pharmacotherapy Publications, Inc.

A clinical nutrition course to improve pharmacy students' skills and confidence in counseling patients.

PubMed

Chang, Linda; Popovich, Nicholas G; Iramaneerat, Cherdsak; Smith, Everett V; Lutfiyya, M Nawal

2008-06-15

To create, implement, and evaluate a PharmD course on primary care nutrition. A 2-credit hour elective course was offered to second- and third-year pharmacy students. It was informed by the Socratic method using a minimum number of formal lecture presentations and featured problem-based learning exercises, case-based scenarios, and scientific literature to fuel informed debate. A single group posttest design with a retrospective pretest was used to assess students' self-efficacy. There was a significant overall improvement in students' self-efficacy in their ability to practice primary care nutrition. Completion of a nutrition course improved students' confidence in providing primary care nutrition and empowered them to speak more comfortably about the role of nutrition in the prevention of chronic diseases.

Assessing Interval Estimation Methods for Hill Model Parameters in a High-Throughput Screening Context (SOT)

EPA Science Inventory

The Hill model of concentration-response is ubiquitous in toxicology, perhaps because its parameters directly relate to biologically significant metrics of toxicity such as efficacy and potency. Point estimates of these parameters obtained through least squares regression or maxi...

Assessing Interval Estimation Methods for Hill Model Parameters in a High-Throughput Screening Context (IVIVE meeting)

EPA Science Inventory

The Hill model of concentration-response is ubiquitous in toxicology, perhaps because its parameters directly relate to biologically significant metrics of toxicity such as efficacy and potency. Point estimates of these parameters obtained through least squares regression or maxi...

A Prospective, Randomized, Multicenter Clinical Trial on the Safety and Efficacy of a Ready-to-Use Fibrin Sealant as an Adjunct to Hemostasis during Vascular Surgery.

PubMed

Chetter, Ian; Stansby, Gerard; Sarralde, José Aurelio; Riambau, Vicente; Giménez-Gaibar, Antonio; MacKenzie, Kent; Acín, Francisco; Navarro-Puerto, Jordi

2017-11-01

Anastomotic or "stitch hole" bleeding is common during vascular surgery with synthetic material such as Dacron or polytetrafluoroethylene. Hemostatic adjuncts such as fibrin sealant (FS) may reduce blood loss and operating time in such circumstances. We evaluated the safety and the hemostatic effectiveness of a ready-to-use human plasma-derived FS in vascular surgery. Patients with mild/moderate suture line bleeding during elective, open, vascular surgery using synthetic grafts or patches were studied. In an initial Exploratory Study, all patients were treated with FS Grifols, and in a subsequent Primary Study were randomized in a 2:1 ratio to FS Grifols or manual compression (MC). The primary efficacy end point was time to hemostasis (TTH), assessed at defined intervals from the start of treatment application, during a 10-min observational period. Safety end points (in Exploratory + Primary Studies) included adverse events (AEs), vital signs, physical assessments, common clinical laboratory tests (coagulation, complete blood count, serum clinical chemistry parameters, microscopic urinalysis), viral markers, and immunogenicity. In the Primary Study, the proportion of patients who achieved hemostasis at the 3-min time point was higher in the FS Grifols group (46.4%, n = 51/110) than in the MC group (26.3%, n = 15/57) (P < 0.05). The benefit was maintained at successive time intervals: 69 FS Grifols patients (62.7%) and 18 MC patients (31.6%) at 4 min; 82 FS Grifols patients (74.5%) and 28 MC patients (49.1%) at 5 min. The differences between the groups persisted for TTH ≤ 7 min and TTH ≤ 10 min. Treatment failure was reported for 13 FS Grifols patients (11.8%) and 16 MC patients (28.1%). TTH was shorter after FS Grifols application than after MC application. Differences were statistically significant in favor of FS Grifols for each TTH category and for the overall comparison (P < 0.001) as well as for each TTH category (cumulative) and for treatment failure (P = 0.016). Overall, AE experience and types of AEs reported were those expected in this patient population and were similar between the 2 treatment groups. The most frequently reported AEs were procedural pain (59.9% and 69.2% of patients in the FS Grifols [n = 72 + 111] and MC [n = 57] groups, respectively) and nausea (23.5% and 19.2% of patients, respectively). FS Grifols was efficacious and safe as an adjunct to anastomotic hemostasis in patients undergoing arterial surgery using prosthetic material with mild to moderate bleeding. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

A Comparison of Robotic Versus Laparoscopic Adrenalectomy in Patients With Primary Hyperaldosteronism.

PubMed

Colvin, Jennifer; Krishnamurthy, Vikram; Jin, Judy; Shin, Joyce; Siperstein, Allan; Berber, Eren

2017-10-01

Over the last decade, robotic approaches have been described for removing adrenal tumors. Although there are reports comparing robotic and laparoscopic techniques in general, there are limited data on outcomes in patients with primary hyperaldosteronism (PHA). The aim of this study is to compare the safety and efficacy of robotic adrenalectomy (RA) versus laparoscopic adrenalectomy (LA) for PHA. The records of 20 patients who underwent RA for PHA were compared with 16 patients who underwent LA between 2000 and 2014. Data were retrospectively reviewed from a prospectively maintained, IRB-approved adrenal database. Statistical analysis was performed using t test and the Fisher exact analysis. Continuous variables are reported as mean±SEM. Demographic and clinical parameters were similar between the groups. There were no conversions to open in either group. Estimated blood loss, length of stay, and complication rates were comparable. Operative time was shorter in the robotic versus laparoscopic group (130±8.94 vs. 159±11.1 min, P=0.0487). In follow-up, the improvement in patients' blood pressure after adrenalectomy, as assessed by the reduction in the number of antihypertensive medications, was similar between the 2 groups. However, 1 patient in the RA and 1 patient in the LA group were not cured, as determined by postoperative aldosterone:renin levels. The biochemical cure rate between the groups was similar (P=0.529). To our knowledge, this is the first study comparing robotic versus laparoscopic resection of PHA. Our results show that the robotic approach was similar to laparoscopic regarding safety and efficacy. Operative time was shorter with the robotic approach, which could be related to more efficient dissection with wristed instrumentation.

Semuloparin for prevention of venous thromboembolism after major orthopedic surgery: results from three randomized clinical trials, SAVE-HIP1, SAVE-HIP2 and SAVE-KNEE.

PubMed

Lassen, M R; Fisher, W; Mouret, P; Agnelli, G; George, D; Kakkar, A; Mismetti, P; Turpie, A G G

2012-05-01

Semuloparin is a novel ultra-low-molecular-weight heparin under development for venous thromboembolism (VTE) prevention in patients at increased risk, such as surgical and cancer patients. Three Phase III studies compared semuloparin and enoxaparin after major orthopedic surgery: elective knee replacement (SAVE-KNEE), elective hip replacement (SAVE-HIP1) and hip fracture surgery (SAVE-HIP2). All studies were multinational, randomized and double-blind. Semuloparin and enoxaparin were administered for 7-10 days after surgery. Mandatory bilateral venography was to be performed between days 7 and 11. The primary efficacy endpoint was a composite of any deep vein thrombosis, non-fatal pulmonary embolism or all-cause death. Safety outcomes included major bleeding, clinically relevant non-major (CRNM) bleeding, and any clinically relevant bleeding (major bleeding plus CRNM). In total, 1150, 2326 and 1003 patients were randomized in SAVE-KNEE, SAVE-HIP1 and SAVE-HIP2, respectively. In all studies, the incidences of the primary efficacy endpoint were numerically lower in the semuloparin group vs. the enoxaparin group, but the difference was statistically significant only in SAVE-HIP1. In SAVE-HIP1, clinically relevant bleeding and major bleeding were significantly lower in the semuloparin vs. the enoxaparin group. In SAVE-KNEE and SAVE-HIP2, clinically relevant bleeding tended to be higher in the semuloparin group, but rates of major bleeding were similar in the two groups. Other safety parameters were generally similar between treatment groups. Semuloparin was superior to enoxaparin for VTE prevention after hip replacement surgery, but failed to demonstrate superiority after knee replacement surgery and hip fracture surgery. Semuloparin and enoxaparin exhibited generally similar safety profiles. © 2012 International Society on Thrombosis and Haemostasis.

A Prospective, Nonrandomized, Open-Label Study of the Efficacy and Safety of OnabotulinumtoxinA in Adolescents with Primary Axillary Hyperhidrosis.

PubMed

Glaser, Dee Anna; Pariser, David M; Hebert, Adelaide A; Landells, Ian; Somogyi, Chris; Weng, Emily; Brin, Mitchell F; Beddingfield, Frederick

2015-01-01

To evaluate the efficacy and safety of onabotulinumtoxinA in adolescents with primary axillary hyperhidrosis. This 52-week, multicenter, nonrandomized, open-label study was conducted in 141 adolescents ages 12 to 17 years with severe primary axillary hyperhidrosis. Patients could receive up to six treatments with onabotulinumtoxinA (50 U per axilla), with re-treatment occurring no sooner than 8 weeks after the prior treatment cycle and no later than 44 weeks after the initial treatment cycle. The primary efficacy measure was treatment response, based on self-assessed hyperhidrosis severity following the first two treatments using the 4-point Hyperhidrosis Disease Severity Scale (HDSS). Other efficacy measures included spontaneous resting sweat production and health outcomes. Fifty-six (38.9%) participants underwent one treatment, 59 (41.0%) underwent two, 20 (13.9%) underwent three, 6 (4.2%) underwent four, and 3 (2.1%) underwent five. OnabotulinumtoxinA significantly improved HDSS scores and decreased sweat production compared with treatment cycle baselines. Seventy-nine patients (54.9%) responded to treatment based on HDSS criteria. From 56.6% to 72.3% of patients experienced a two-grade or more improvement at 4 and 8 weeks after each of the first two treatments. The majority (79.4%-93.2%) had a 75% or greater reduction in sweat production at week 4 (treatments 1-3). The median duration of effect for responders ranged from 134 to 152 days. Using quality of life measures, health outcomes improved markedly. Eight patients (5.6%) had mild or moderate treatment-related adverse events. No unexpected safety signals were observed in this study. Neutralizing antibodies to onabotulinumtoxinA did not develop. OnabotulinumtoxinA injections provided beneficial effects in adolescents with primary axillary hyperhidrosis. © 2015 The Authors. Pediatric Dermatology Published by Wiley Periodicals, Inc.

Satisfaction With Knee Function After Primary Anterior Cruciate Ligament Reconstruction Is Associated With Self-Efficacy, Quality of Life, and Returning to the Preinjury Physical Activity.

PubMed

Ardern, Clare L; Österberg, Annika; Sonesson, Sofi; Gauffin, Håkan; Webster, Kate E; Kvist, Joanna

2016-08-01

To assess whether patient-reported outcomes (psychological factors, appraisals of knee function, and physical activity participation) were associated with satisfaction with knee function after anterior cruciate ligament (ACL) reconstruction. Participants who were aged 18 to 45 years and a minimum 12 months post primary ACL reconstruction completed a questionnaire battery evaluating knee self-efficacy, knee-related quality of life, self-reported function, and physical activity participation. Participants' responses to the question "If you were to spend the rest of your life with your knee just the way it has been in the last week, would you feel . . . (7-point ordinal scale; 1 = happy, 7 = unhappy)" were categorized as satisfied, mostly satisfied, or dissatisfied and used as the primary outcome. Ordinal regression was used to examine associations between independent variables and the primary outcome. A total of 177 participants were included at an average of 3 years after primary ACL reconstruction. At follow-up, 44% reported they would be satisfied, 28% mostly satisfied, and 28% dissatisfied with the outcome of ACL reconstruction. There were significant differences in psychological responses and appraisal of knee function between the 3 groups (P = .001), and significantly more people in the satisfied group had returned to their preinjury activity (58%) than in the mostly satisfied (28%) and dissatisfied (26%) groups (P = .001). Multivariable analysis demonstrated that the odds of being satisfied increased by a factor of 3 with higher self-efficacy, greater knee-related quality of life, and returning to the preinjury activity. People who had returned to their preinjury physical activity and who reported higher knee-related self-efficacy and quality of life were more likely to be satisfied with the outcome of ACL reconstruction. Level IV, prognostic case series. Copyright © 2016 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Improving the Efficiency and Efficacy of Glibenclamide in Limiting Progressive Hemorrhagic Necrosis Following Traumatic Spinal Cord Injury

DTIC Science & Technology

2015-02-01

diabetic drug that targets SUR1 receptors on endothelia. In an attempt to replicate primary research data showing that Glib has potent neuroprotective...high-field T1 and T2 weighted MRI imaging protocols in rat model of SCI. • Established that glibenclamide is neuroprotective across different types...glibenclamide efficacy within 24h post-SCI. • Compared the relative efficacy of glibenclamide with other neuroprotective drugs (Riluzole, systemic

Preclinical safety and efficacy of a new recombinant FIX drug product for treatment of hemophilia B.

PubMed

Dietrich, Barbara; Schiviz, Alexandra; Hoellriegl, Werner; Horling, Frank; Benamara, Karima; Rottensteiner, Hanspeter; Turecek, Peter L; Schwarz, Hans Peter; Scheiflinger, Friedrich; Muchitsch, Eva-Maria

2013-11-01

Baxter has developed a new recombinant factor IX (rFIX) drug product (BAX326) for treating patients with hemophilia B, or congenital FIX deficiency. An extensive preclinical program evaluated the pharmacokinetics, efficacy, and safety of BAX326 in different species. The efficacy of BAX326 was tested in three mouse models of primary pharmacodynamics: tail-tip bleeding, carotid occlusion, and thrombelastography. The pharmacokinetics was evaluated after a single intravenous bolus injection in mice, rats, and macaques. Toxicity was assessed in rats and macaques, safety pharmacology in rabbits and macaques, and immunogenicity in mice. BAX326 was shown to be efficacious in all three primary pharmacodynamic studies (P ≤ 0.0076). Hemostatic efficacy was dose related and similar for the three lots tested. Pharmacokinetic results showed that rFIX activity and rFIX antigen concentrations declined in a bi-phasic manner, similar to a previously licensed rFIX product. BAX326 was well tolerated in rabbits and macaques at all dose levels; no thrombogenic events and no adverse clinical, respiratory, or cardiovascular effects occurred. BAX326 was also shown to have a similar immunogenicity profile to the comparator rFIX product in mice. These results demonstrate that BAX326 has a favorable preclinical safety and efficacy profile, predictive of a comparable effect to that of the previously licensed rFIX in humans.

Antagonism of SET using OP449 enhances the efficacy of tyrosine kinase inhibitors and overcome drug resistance in myeloid leukemia

PubMed Central

Agarwal, Anupriya; MacKenzie, Ryan J.; Pippa, Raffaella; Eide, Christopher A.; Oddo, Jessica; Tyner, Jeffrey W.; Sears, Rosalie; Vitek, Michael P.; Odero, María D.; Christensen, Dale; Druker, Brian J.

2014-01-01

Purpose The SET oncoprotein, a potent inhibitor of the protein phosphatase 2A (PP2A), is overexpressed in leukemia. We evaluated the efficacy of SET antagonism in chronic myeloid leukemia (CML) and acute myeloid leukemia (AML) cell lines, a murine leukemia model, and primary patient samples using OP449, a specific, cell-penetrating peptide that antagonizes SET's inhibition of PP2A. Experimental Design In vitro cytotoxicity and specificity of OP449 in CML and AML cell lines and primary samples were measured using proliferation, apoptosis and colonogenic assays. Efficacy of target inhibition by OP449 is evaluated by immunoblotting and PP2A assay. In vivo antitumor efficacy of OP449 was measured in human HL-60 xenografted murine model. Results We observed that OP449 inhibited growth of CML cells including those from patients with blastic phase disease and patients harboring highly drug-resistant BCR-ABL1 mutations. Combined treatment with OP449 and ABL1 tyrosine kinase inhibitors was significantly more cytotoxic to K562 cells and primary CD34+ CML cells. SET protein levels remained unchanged with OP449 treatment, but BCR-ABL1-mediated downstream signaling was significantly inhibited with the degradation of key signaling molecules such as BCR-ABL1, STAT5, and AKT. Similarly, AML cell lines and primary patient samples with various genetic lesions showed inhibition of cell growth after treatment with OP449 alone or in combination with respective kinase inhibitors. Finally, OP449 reduced the tumor burden of mice xenografted with human leukemia cells. Conclusions We demonstrate a novel therapeutic paradigm of SET antagonism using OP449 in combination with tyrosine kinase inhibitors for the treatment of CML and AML. PMID:24436473

Parameters for defining efficacy in fracture healing

PubMed Central

Shisha, Tamas

2010-01-01

Complications of the bone-healing process, especially in elderly, osteoporotic patients, are cause of important medical and economical burden. At the same time, there is no clinical study today to have shown the efficacy of a pharmacological treatment to enhance fracture repair. The author analyzes the potential criteria that could be used for the evaluation of treatment efficacy to enhance fracture healing in the frame of a clinical study. PMID:22461284

The Optimal Timing of Hepatitis C Therapy in Transplant Eligible Patients With Child B and C Cirrhosis: A Cost-Effectiveness Analysis.

PubMed

Tapper, Elliot B; Hughes, Michael S; Buti, Maria; Dufour, Jean-Francois; Flamm, Steve; Firdoos, Saima; Curry, Michael P; Afdhal, Nezam H

2017-05-01

Ledipasvir (LDV)/sofosbuvir (SOF) has demonstrated high efficacy, safety, and tolerability in hepatitis C virus (HCV)-infected patients. There is limited data, however, regarding the optimal timing of therapy in the context of possible liver transplantation (LT). We compared the cost-effectiveness of 12 weeks of HCV therapy before or after LT or nontreatment using a decision analytical microsimulation state-transition model for a simulated cohort of 10 000 patients with HCV Genotype 1 or 4 with Child B or C cirrhosis. All model parameters regarding the efficacy of therapy, adverse events and the effect of therapy on changes in model for end-stage liver disease (MELD) scores were derived from the SOLAR-1 and 2 trials. The simulations were repeated with 10 000 samples from the parameter distributions. The primary outcome was cost (2014 US dollars) per quality adjusted life year. Treatment before LT yielded more quality-adjusted life year for less money than treatment after LT or nontreatment. Treatment before LT was cost-effective in 100% of samples at a willingness-to-pay threshold of US $100 000 in the base-case and when the analysis was restricted to Child B alone, Child C, or MELD > 15. Treatment before transplant was not cost-effective when MELD was 6-10. In sensitivity analyses, the MELD after which treatment before transplant was cost-effective was 13 and the maximum cost of LDV/SOF therapy at which treatment before LT is cost-effective is US $177 381. From a societal perspective, HCV therapy using LDV/SOF with ribavirin before LT is the most cost-effective strategy for patients with decompensated cirrhosis and MELD score greater than 13.

Reversal of clopidogrel-induced bleeding with rFVIIa in healthy subjects: a randomized, placebo-controlled, double-blind, exploratory study.

PubMed

Skolnick, Brett E; Shenouda, Magdy; Khutoryansky, Naum M; Pusateri, Anthony E; Gabriel, Don; Carr, Marcus E

2011-10-01

Clopidogrel (Plavix®) therapy, although effective for minimizing risk of thrombotic events, is also associated with potential bleeding risk. Recombinant activated FVII (rFVIIa, NovoSeven®) induces hemostasis in hemophilia patients with inhibitors (alloantibodies) and has been proposed as potential treatment for mitigating clopidogrel therapy-mediated bleeding. In this single-center, randomized, placebo-controlled, double-blind, dose-escalation, exploratory phase I trial, we assessed the safety and effects of rFVIIa in reversing clopidogrel-enhanced bleeding in an experimentally induced punch biopsy in healthy subjects. Efficacy assessments included the reversal of bleeding characteristics (bleed duration [BD], the primary end point and blood loss volume [BV] induced by punch biopsy, and thromboelastograph [TEG®] parameters) with rFVIIa or placebo after clopidogrel treatment. A significant number of subjects (56%) had limited response to clopidogrel (defined as ≤30% platelet aggregation inhibition) and were discontinued from study. The remaining subjects continued and had 4 biopsies. Of 40 subjects randomized, 37 were evaluated for efficacy. Clopidogrel treatment increased BD and BV compared with the baseline biopsy. Recombinant FVIIa (10 and 20 μg/kg) significantly mitigated the clopidogrel-induced effects on BV (P = 0.007 and P = 0.001, respectively). Early trial termination limited the evaluation of effects of higher rFVIIa doses. Subgroup analyses of subjects biopsied by the same physician demonstrated significant reduction of clopidogrel-induced BD with 20 μg/kg rFVIIa (P = 0.048). Ex vivo analysis of rFVIIa demonstrated clotting dynamics presented by parameters time to clot onset (TEG®-R) and clot angle (TEG®-A) (P < 0.005). In this clinical study, rFVIIa (10 and 20 μg/kg) reversed the effect of clopidogrel on blood loss.

Usefulness of Icosapent Ethyl (Eicosapentaenoic Acid Ethyl Ester) in Women to Lower Triglyceride Levels (Results from the MARINE and ANCHOR Trials).

PubMed

Mosca, Lori; Ballantyne, Christie M; Bays, Harold E; Guyton, John R; Philip, Sephy; Doyle, Ralph T; Juliano, Rebecca A

2017-02-01

There are limited data on the efficacy and safety of triglyceride (TG)-lowering agents in women. We conducted subgroup analyses of the effects of icosapent ethyl (a high-purity prescription form of the ethyl ester of the omega-3 fatty acid, eicosapentaenoic acid) on TG levels (primary efficacy variable) and other atherogenic and inflammatory parameters in a total of 215 women with a broad range of TG levels (200-2000 mg/dl) enrolled in two 12-week placebo-controlled trials: MARINE (n = 18; placebo, n = 18) and ANCHOR (n = 91; placebo, n = 88). Icosapent ethyl 4 g/day significantly reduced TG levels from baseline to week 12 versus placebo in both MARINE (-22.7%; p = 0.0327) and ANCHOR (-21.5%; p <0.0001) without increasing low-density lipoprotein cholesterol levels. Significant improvements were also observed in non-high-density lipoprotein cholesterol levels in MARINE (-15.7%; p = 0.0082) and ANCHOR (-14.2%; p <0.0001) and total cholesterol levels in MARINE (-14.9%; p = 0.0023) and ANCHOR (-12.1%; p <0.0001), along with significant increases of >500% in eicosapentaenoic acid levels in plasma and red blood cells (all p <0.001). Icosapent ethyl was well tolerated, with adverse-event profiles comparable with findings in the overall studies. In conclusion, icosapent ethyl 4 g/day significantly reduced TG levels and other atherogenic parameters in women without increasing low-density lipoprotein cholesterol levels compared with placebo; the clinical implications of these findings are being evaluated in the REDUCtion of Cardiovascular Events With Eicosapentaenoic Acid [EPA]-Intervention Trial (REDUCE-IT) cardiovascular outcomes study. Copyright © 2016 The Author(s). Published by Elsevier Inc. All rights reserved.

Asthma exacerbations after the East Japan Disaster.

PubMed

Ishiura, Yoshihisa; Fujimura, Masaki; Yamamoto, Hiroki; Shiba, Yasutaka; Ohkura, Noriyuki; Kasahara, Kazuo; Ishida, Youichi

2013-01-01

On March 11, 2011, a 9.0-magnitude earthquake struck east Japan, following tsunami. Many people are forced to live in evacuation shelters without enough life-saving drugs. Asthma control for management of health crisis is required, because asthma exacerbation is a major cause of morbidity, can need acute care and results in death. However, it remains obscure what parameter should be used in primary clinic of evacuation shelters. The objective of this study is to elucidate the practical efficacy of asthma assessment tool in primary clinic for victims of this disaster. Asthma control test (ACT), a brief and patient-based tool to evaluate asthma control, was conducted for 17 patients with asthma in evacuation shelters at Tohoku district. Total sum of ACT scores were significantly decreased after this disaster. Significant decreases were observed for the items; "Asthma keeps you from getting much done at work", "Shortness of breath", "Asthma symptoms wake you up" and "Patient rating of control". ACT, an easy and practicable tool, clearly demonstrated the asthma exacerbation in evacuation shelters without the use of lung function testing. ACT may contribute to the management of health crisis not only for this East Japan disaster but also for the other forthcoming unavoidable disasters.

Efficacy and Safety of As-Needed, Post Bedtime Dosing with Indiplon in Insomnia Patients with Chronic Difficulty Maintaining Sleep

PubMed Central

Roth, Thomas; Zammit, Gary K.; Scharf, Martin B.; Farber, Robert

2007-01-01

Objective: To evaluate the efficacy and tolerability of immediate release indiplon capsules in patients with chronic insomnia using an “as-needed” dosing strategy in response to difficulty falling back to sleep following a middle of the night, nocturnal awakening. Methods: Adult outpatients (N=264; 71% female; age, 46 years) who met DSM-IV criteria for primary insomnia, with average total sleep time (TST) <6.5 hours and >8 nights in the past month with nocturnal awakenings, were randomized to 4 weeks of double-blind treatment with 10mg or 20mg indiplon capsules, or placebo. The primary endpoint was latency to sleep onset post-dosing after a middle of the night awakening (LSOpd). Secondary endpoints included patients' subjective assessment of total sleep time (sTSTpd). Next day residual effects were evaluated by a 100mm Visual Analog Scale (VAS) rating of sleepiness. Results: Both doses of indiplon significantly reduced LSOpd at all time-points. Compared to placebo (45.2 min), the 4-week least squares (LS) mean LSOpd was 36.5 min in the indiplon 10mg group (P=0.0023) and 34.4 min in the indiplon 20mg group (P<0.0001). The 4-week LS mean sTSTpd was higher in the indiplon 10mg group (253 min) and 20mg group (278 min) compared to placebo (229 min; P<0.01 for both comparisons). There was no increase observed in VAS ratings of next-day sleepiness for either dose of indiplon when compared to placebo. Indiplon was well-tolerated at both doses. Conclusions: Patients with chronic insomnia with nocturnal awakenings achieved significant and sustained improvement in sleep parameters while utilizing an as-needed post bedtime dosing strategy with indiplon capsules. Indiplon was well-tolerated, with no self-rated, next-day residual effects. Citation: Roth T; Zammit GK; Scharf MB; Farber R. Efficacy and safety of as-needed, post bedtime dosing with indiplon in insomnia patients with chronic difficulty maintaining sleep. SLEEP 2007;30(12):1731-1738. PMID:18246982

Effect of homeopathy on analgesic intake following knee ligament reconstruction: a phase III monocentre randomized placebo controlled study

PubMed Central

Paris, A; Gonnet, N; Chaussard, C; Belon, P; Rocourt, F; Saragaglia, D; Cracowski, J L

2008-01-01

Aims The efficacy of homeopathy is still under debate. The objective of this study was to assess the efficacy of homeopathic treatment (Arnica montana 5 CH, Bryonia alba 5 CH, Hypericum perforatum 5 CH and Ruta graveolens 3 DH) on cumulated morphine intake delivered by PCA over 24 h after knee ligament reconstruction. Methods This was an add-on randomized controlled study with three parallel groups: a double-blind homeopathic or placebo arm and an open-label noninterventional control arm. Eligible patients were 18–60 years old candidates for surgery of the anterior cruciate ligament. Treatment was administered the evening before surgery and continued for 3 days. The primary end-point was cumulated morphine intake delivered by PCA during the first 24 h inferior or superior/equal to 10 mg day−1. Results One hundred and fifty-eight patients were randomized (66 in the placebo arm, 67 in the homeopathic arm and 25 in the noninterventional group). There was no difference between the treated and the placebo group for primary end-point (mean (95% CI) 48% (35.8, 56.3), and 56% (43.7, 68.3), required less than 10 mg day−1 of morphine in each group, respectively). The homeopathy treatment had no effect on morphine intake between 24 and 72 h or on the visual analogue pain scale, or on quality of life assessed by the SF-36 questionnaire. In addition, these parameters were not different in patients enrolled in the open-label noninterventional control arm. Conclusions The complex of homeopathy tested in this study was not superior to placebo in reducing 24 h morphine consumption after knee ligament reconstruction. What is already known about this subject The efficacy of homeopathy is still under debate and a recent meta-analysis recommended further randomized double-blind clinical trials to identify any clinical situation in which homeopathy might be effective. What this study adds The complex of homeopathy tested in this study (Arnica montana 5 CH, Bryonia alba 5 CH, Hypericum perforatum 5 CH and Ruta graveolens 3 DH) is not superior to placebo in reducing 24 h morphine consumption after knee ligament reconstruction. PMID:18251757

Activation and Self-Efficacy in a Randomized Trial of a Depression Self-Care Intervention

ERIC Educational Resources Information Center

McCusker, Jane; Lambert, Sylvie D.; Cole, Martin G.; Ciampi, Antonio; Strumpf, Erin; Freeman, Ellen E.; Belzile, Eric

2016-01-01

Objectives: In a sample of primary care participants with chronic physical conditions and comorbid depressive symptoms: to describe the cross-sectional and longitudinal associations of activation and self-efficacy with demographic, physical and mental health status, health behaviors, depression self-care, health care utilization, and use of…

Bully/Victim Problems and Their Association with Machiavellianism and Self-Efficacy in Greek Primary School Children

ERIC Educational Resources Information Center

Andreou, E.

2004-01-01

Background: Previous research demonstrated that Machiavellian beliefs are linked with bully/victim problems at school. However, Machiavellianism was treated as a single construct and not as multidimensional. Children's perceptions of self-efficacy in both social and academic domains have been related to conflictual peer interactions but not…

Developments in Motivation and Achievement during Primary School: A Longitudinal Study on Group-Specific Differences

ERIC Educational Resources Information Center

Hornstra, Lisette; van der Veen, Ineke; Peetsma, Thea; Volman, Monique

2013-01-01

To gain insight in developmental trajectories of motivation during upper primary school, the present study focused on how different aspects of students' motivation, i.e., task-orientation, self-efficacy, and school investment develop from grade three to six of primary school and how these developments differ for boys and girls, and students with…

HIV Model Parameter Estimates from Interruption Trial Data including Drug Efficacy and Reservoir Dynamics

PubMed Central

Luo, Rutao; Piovoso, Michael J.; Martinez-Picado, Javier; Zurakowski, Ryan

2012-01-01

Mathematical models based on ordinary differential equations (ODE) have had significant impact on understanding HIV disease dynamics and optimizing patient treatment. A model that characterizes the essential disease dynamics can be used for prediction only if the model parameters are identifiable from clinical data. Most previous parameter identification studies for HIV have used sparsely sampled data from the decay phase following the introduction of therapy. In this paper, model parameters are identified from frequently sampled viral-load data taken from ten patients enrolled in the previously published AutoVac HAART interruption study, providing between 69 and 114 viral load measurements from 3–5 phases of viral decay and rebound for each patient. This dataset is considerably larger than those used in previously published parameter estimation studies. Furthermore, the measurements come from two separate experimental conditions, which allows for the direct estimation of drug efficacy and reservoir contribution rates, two parameters that cannot be identified from decay-phase data alone. A Markov-Chain Monte-Carlo method is used to estimate the model parameter values, with initial estimates obtained using nonlinear least-squares methods. The posterior distributions of the parameter estimates are reported and compared for all patients. PMID:22815727

Limits on the maximum attainable efficiency for solid-state lighting

NASA Astrophysics Data System (ADS)

Coltrin, Michael E.; Tsao, Jeffrey Y.; Ohno, Yoshi

2008-03-01

Artificial lighting for general illumination purposes accounts for over 8% of global primary energy consumption. However, the traditional lighting technologies in use today, i.e., incandescent, fluorescent, and high-intensity discharge lamps, are not very efficient, with less than about 25% of the input power being converted to useful light. Solid-state lighting is a rapidly evolving, emerging technology whose efficiency of conversion of electricity to visible white light is likely to approach 50% within the next years. This efficiency is significantly higher than that of traditional lighting technologies, with the potential to enable a marked reduction in the rate of world energy consumption. There is no fundamental physical reason why efficiencies well beyond 50% could not be achieved, which could enable even greater world energy savings. The maximum achievable luminous efficacy for a solid-state lighting source depends on many different physical parameters, for example the color rendering quality that is required, the architecture employed to produce the component light colors that are mixed to produce white, and the efficiency of light sources producing each color component. In this article, we discuss in some detail several approaches to solid-state lighting and the maximum luminous efficacy that could be attained, given various constraints such as those listed above.

The Emerging Role for rTMS in Optimizing the Treatment of Adolescent Depression

PubMed Central

Croarkin, Paul E.; Wall, Christopher A.; McClintock, Shawn M.; Kozel, F. Andrew; Husain, Mustafa M.; Sampson, Shirlene M.

2010-01-01

Major depressive disorder (MDD) in adolescents is a common illness and significant public health problem. Treatment is challenging due to recurrences and limited modalities. Selective serotonin reuptake inhibitors (SSRIs) and Cognitive Behavioral Therapy (CBT) are considered the standard of care in severe or treatment resistant MDD in this age group. However, responses to these interventions are often suboptimal. A growing body of research supports the efficacy of repetitive transcranial magnetic stimulation for the treatment of MDD in adults. Induced seizures are a primary safety concern, although this is rare with appropriate precautions. There is, however, limited experience with rTMS as a therapeutic intervention for adolescent psychiatric disturbances. This review will summarize the rTMS efficacy and safety data in adults and describe all published experience with adolescent MDD. Applications in other adolescent psychiatric illnesses such as schizophrenia and attention-deficit/hyperactivity disorder (ADHD) are reviewed. Safety and ethical issues are paramount with investigational treatments in adolescent psychiatric illnesses. However, further research with rTMS in adolescent MDD is imperative to establish standards for optimal stimulation site, treatment parameters, and its role in treatment algorithms. These may diverge from adult data. Early intervention with neuromodulation could also hold the promise of addressing the developmental course of dysfunctional neurocircuitry. PMID:20418774

Evaluation of standardized sample collection, packaging, and ...

EPA Pesticide Factsheets

Journal Sample collection procedures and primary receptacle (sample container and bag) decontamination methods should prevent contaminant transfer between contaminated and non-contaminated surfaces and areas during bio-incident operations. Cross-contamination of personnel, equipment, or sample containers may result in the exfiltration of biological agent from the exclusion (hot) zone and have unintended negative consequences on response resources, activities and outcomes. The current study was designed to: (1) evaluate currently recommended sample collection and packaging procedures to identify procedural steps that may increase the likelihood of spore exfiltration or contaminant transfer; (2) evaluate the efficacy of currently recommended primary receptacle decontamination procedures; and (3) evaluate the efficacy of outer packaging decontamination methods. Wet- and dry-deposited fluorescent tracer powder was used in contaminant transfer tests to qualitatively evaluate the currently-recommended sample collection procedures. Bacillus atrophaeus spores, a surrogate for Bacillus anthracis, were used to evaluate the efficacy of spray- and wipe-based decontamination procedures.

Rationale, Design, and Baseline Characteristics of Beijing Prediabetes Reversion Program: A Randomized Controlled Clinical Trial to Evaluate the Efficacy of Lifestyle Intervention and/or Pioglitazone in Reversion to Normal Glucose Tolerance in Prediabetes

PubMed Central

Luo, Yingying; Paul, Sanjoy K.; Zhou, Xianghai; Chang, Cuiqing; Guo, Xiaohui; Yang, Jinkui

2017-01-01

Background. Patients with prediabetes are at high risk for diabetes and cardiovascular disease (CVD). No study has explored whether intervention could revert prediabetes to normal glycemic status as the primary outcome. Beijing Prediabetes Reversion Program (BPRP) would evaluate whether intensive lifestyle modification and/or pioglitazone could revert prediabetic state to normoglycemia and improve the risk factors of CVD as well. Methods. BPRP is a randomized, multicenter, 2 × 2 factorial design study. Participants diagnosed as prediabetes were randomized into four groups (conventional/intensive lifestyle intervention and 30 mg pioglitazone/placebo) with a three-year follow-up. The primary endpoint was conversion into normal glucose tolerance. The trial would recruit 2000 participants (500 in each arm). Results. Between March 2007 and March 2011, 1945 participants were randomized. At baseline, the individuals were 53 ± 10 years old, with median BMI 26.0 (23.9, 28.2) kg/m2 and HbA1c 5.8 (5.6, 6.1)%. 85% of the participants had IGT and 15% had IFG. Parameters relevant to glucose, lipids, blood pressure, lifestyle, and other metabolic markers were similar between conventional and intensive lifestyle intervention group at baseline. Conclusion. BPRP was the first study to determine if lifestyle modification and/or pioglitazone could revert prediabetic state to normoglycemia in Chinese population. Major baseline parameters were balanced between two lifestyle intervention groups. This trial is registered with www.chictr.org.cn: ChiCTR-PRC-06000005. PMID:28168204

Rationale, Design, and Baseline Characteristics of Beijing Prediabetes Reversion Program: A Randomized Controlled Clinical Trial to Evaluate the Efficacy of Lifestyle Intervention and/or Pioglitazone in Reversion to Normal Glucose Tolerance in Prediabetes.

PubMed

Luo, Yingying; Paul, Sanjoy K; Zhou, Xianghai; Chang, Cuiqing; Chen, Wei; Guo, Xiaohui; Yang, Jinkui; Ji, Linong; Wang, Hongyuan

2017-01-01

Background . Patients with prediabetes are at high risk for diabetes and cardiovascular disease (CVD). No study has explored whether intervention could revert prediabetes to normal glycemic status as the primary outcome. Beijing Prediabetes Reversion Program (BPRP) would evaluate whether intensive lifestyle modification and/or pioglitazone could revert prediabetic state to normoglycemia and improve the risk factors of CVD as well. Methods . BPRP is a randomized, multicenter, 2 × 2 factorial design study. Participants diagnosed as prediabetes were randomized into four groups (conventional/intensive lifestyle intervention and 30 mg pioglitazone/placebo) with a three-year follow-up. The primary endpoint was conversion into normal glucose tolerance. The trial would recruit 2000 participants (500 in each arm). Results . Between March 2007 and March 2011, 1945 participants were randomized. At baseline, the individuals were 53 ± 10 years old, with median BMI 26.0 (23.9, 28.2) kg/m 2 and HbA1c 5.8 (5.6, 6.1)%. 85% of the participants had IGT and 15% had IFG. Parameters relevant to glucose, lipids, blood pressure, lifestyle, and other metabolic markers were similar between conventional and intensive lifestyle intervention group at baseline. Conclusion . BPRP was the first study to determine if lifestyle modification and/or pioglitazone could revert prediabetic state to normoglycemia in Chinese population. Major baseline parameters were balanced between two lifestyle intervention groups. This trial is registered with www.chictr.org.cn: ChiCTR-PRC-06000005.

Simplifying "target" intraocular pressure for different stages of primary open-angle glaucoma and primary angle-closure glaucoma.

PubMed

Sihota, Ramanjit; Angmo, Dewang; Ramaswamy, Deepa; Dada, Tanuj

2018-04-01

Lowering of intraocular pressure is currently the only therapeutic measure for Glaucoma management. Many longterm, randomized trials have shown the efficacy of lowering IOP, either by a percentage of baseline, or to a specified level. This has lead to the concept of 'Target" IOP, a range of IOP on therapy, that would stabilize the Glaucoma/prevent further visual field loss, without significantly affecting a patient's quality of life. A clinical staging of Glaucoma by optic nerve head evaluation and perimetric parameters, allows a patient's eye to be categorized as having - mild, moderate or severe Glaucomatous damage. An initial attempt should be made to achieve the following IOP range for both POAG or PACG after an iridotomy. In mild glaucoma the initial target IOP range could be kept as 15-17 mmHg, for moderate glaucoma 12-15 mmHg and in the severe stage of glaucomatous damage 10-12 mmHg. Factoring in baseline IOP, age, vascular perfusion parameters, and change on perimetry or imaging during follow up, this range may be reassessed over 6 months to a year. "Target" IOP requires further lowering when the patient continues to progress or develops a systemic disease such as a TIA. Conversely, in the event of a very elderly or sick patient with stable nerve and visual field over time, the target IOP could be raised and medications reduced. An appropriate use of medications/laser/surgery to achieve such a "Target" IOP range in POAG or PACG can maintain visual fields and quality of life, preventing Glaucoma blindness.

Remotely Programmed Deep Brain Stimulation of the Bilateral Subthalamic Nucleus for the Treatment of Primary Parkinson Disease: A Randomized Controlled Trial Investigating the Safety and Efficacy of a Novel Deep Brain Stimulation System.

PubMed

Li, Dianyou; Zhang, Chencheng; Gault, Judith; Wang, Wei; Liu, Jianmin; Shao, Ming; Zhao, Yanyan; Zeljic, Kristina; Gao, Guodong; Sun, Bomin

2017-01-01

Deep brain stimulation (DBS) is the most commonly performed surgery for the debilitating symptoms of Parkinson disease (PD). However, DBS systems remain largely unaffordable to patients in developing countries, warranting the development of a safe, economically viable, and functionally comparable alternative. To investigate the efficacy and safety of wirelessly programmed DBS of bilateral subthalamic nucleus (STN) in patients with primary PD. Sixty-four patients with primary PD were randomly divided into test and control groups (1:1), where DBS was initiated at either 1 month or 3 months, respectively, after surgery. Safety and efficacy of the treatment were compared between on- and off-medication states 3 months after surgery. Outcome measures included analysis of Unified Parkinson's Disease Rating Scale (UPDRS) scores, duration of "on" periods, and daily equivalent doses of levodopa. All patients were followed up both 6 and 12 months after surgery. Three months after surgery, significant decrease in the UPDRS motor scores were observed for the test group in the off-medication state (25.08 ± 1.00) versus the control group (4.20 ± 1.99). Bilateral wireless programming STN-DBS is safe and effective for patients with primary PD in whom medical management has failed to restore motor function. © 2017 S. Karger AG, Basel.

Efficacy and safety of triptorelin 6-month formulation in patients with central precocious puberty.

PubMed

Klein, Karen; Yang, Joshua; Aisenberg, Javier; Wright, Nancy; Kaplowitz, Paul; Lahlou, Najiba; Linares, Jeannete; Lundström, Eija; Purcea, Daniela; Cassorla, Fernando

2016-11-01

Triptorelin is an established treatment for central precocious puberty (CPP) as 1- and 3-month formulations. The current triptorelin 22.5 mg 6-month formulation is approved for prostate cancer therapy. This is the first study in patients with CPP. The efficacy and safety of the triptorelin 6-month formulation in CPP were investigated. The primary objective was to evaluate the efficacy in achieving luteinizing hormone (LH) suppression to pre-pubertal levels at month 6. This was an international, non-comparative phase III study over 48 weeks. Eighteen medical centers in the US, Chile and Mexico participated. Forty-four treatment naïve patients (39 girls and five boys) aged at treatment start 2-8 years for girls and 2-9 years for boys with an advancement of bone age over chronological age ≥1 year were to be included. Triptorelin was administered im twice at an interval of 24 weeks. LH, follicle stimulating hormone (FSH) (basal and stimulated), estradiol (girls), testosterone (boys), auxological parameters, clinical signs of puberty and safety were assessed. Forty-one patients (93.2%) showed pre-pubertal LH levels (stimulated LH ≤5 IU/L) at month 6 and maintained LH suppression through month 12. The percentage of patients with LH suppression exceeded 93% at each time point and reached 97.7% at month 12. No unexpected drug-related adverse events were reported. The triptorelin 6-month formulation was safe and effective in suppressing the pituitary-gonadal axis in children with CPP. The extended injection interval may improve compliance and increase comfort in the management of CPP.

United States Department of Agriculture-Agricultural Research Service research in application technology for pest management.

PubMed

Smith, L A; Thomson, S J

2003-01-01

A research summary is presented that emphasizes ARS achievements in application technology over the past 2-3 years. Research focused on the improvement of agricultural pesticide application is important from the standpoint of crop protection as well as environmental safety. Application technology research is being actively pursued within the ARS, with a primary focus on application system development, drift management, efficacy enhancement and remote sensing. Research on application systems has included sensor-controlled hooded sprayers, new approaches to direct chemical injection, and aerial electrostatic sprayers. For aerial application, great improvements in on-board flow controllers permit accurate field application of chemicals. Aircraft parameters such as boom position and spray release height are being altered to determine their effect on drift. Other drift management research has focused on testing of low-drift nozzles, evaluation of pulsed spray technologies and evaluation of drift control adjuvants. Research on the use of air curtain sprayers in orchards, air-assist sprayers for row crops and vegetables, and air deflectors on aircraft has documented improvements in application efficacy. Research has shown that the fate of applied chemicals is influenced by soil properties, and this has implications for herbicide efficacy and dissipation in the environment. Remote sensing systems are being used to target areas in the field where pests are present so that spray can be directed to only those areas. Soil and crop conditions influence propensity for weeds and insects to proliferate in any given field area. Research has indicated distinct field patterns favorable for weed growth and insect concentration, which can provide further assistance for targeted spraying.

Efficacy of Intensity Modulated Radiation Therapy After Surgery in Early Stage of Esophageal Carcinoma;

ClinicalTrials.gov

2018-02-22

Esophageal Neoplasm; Esophageal Cancer TNM Staging Primary Tumor (T) T2; Esophageal Cancer TNM Staging Primary Tumor (T) T3; Esophageal Cancer TNM Staging Regional Lymph Nodes (N) N0; Esophageal Cancer TNM Staging Distal Metastasis (M) M0

TC > 0.05 as a Pharmacokinetic Parameter of Paclitaxel for Therapeutic Efficacy and Toxicity in Cancer Patients.

PubMed

Xin, D S; Zhou, L; Li, C Z; Zhang, S Q; Huang, H Q; Qiu, G D; Lin, L F; She, Y Q; Zheng, J T; Chen, C; Fang, L; Chen, Zhe-Sheng; Zhang, S Y

2018-03-05

Paclitaxel (PTX) has remarkable anti-tumor activity, but it causes severe toxicities. There is an urgent need to seek an appropriate pharmacokinetic parameter of PTX to improve treatment efficacy and reduce adverse effects. To evaluate the association of pharmacokinetic parameter TC>0.05 of paclitaxel (PTX) and its therapeutic efficacy and toxicity in patients with solid tumors. A total of 295 patients with ovarian cancer, esophageal cancer, breast cancer, and non-small cell lung cancer (NSCLC), who were admitted to the Tumor Hospital of Shantou University Medical College, China, were recruited for this study. Patients received 3 weeks of PTX chemotherapy. The plasma concentrations of PTX were examined using the MyPaclitaxelTM kit. The patients' PTX TC>0.05 (the time during which PTX plasma concentration exceed 0.05 μmol/L) were calculated based on pharmacokinetic analysis. The results showed that: (1) the concentrations of PTX in these 295 patients ranged from 0.0358-0.127 μmol/L; (2) the PTX TC> 0.05 ranged from 14 to 38 h with a median time of 27 h; (3) among all treatment cycles, there was a statistically significant difference in the PTX TC>0.05 between CR+PR and SD+PD; (4) with the increasing value of TC>0.05, level of leukopenia and leukopenic fever increased; (5) high PTX TC>0.05 led to the occurrence of neutropenia, neutropenic fever, severe anemia, and severe peripheral neurotoxicity. Taken together, our results indicated that the pharmacokinetic parameter PTX TC>0.05 was an effective measure of treatment efficacy and toxicity in patients with solid tumors. Maintaining PTX TC>0.05 at 26 to 30 h could improve its efficacy and reduce the incidence of leukopenia, neutropenia, anemia, and peripheral neurotoxicity in these patients. PTX TC>0.05 is a key pharmacokinetic parameter of PTX which should be monitored to optimize individual treatment in patients with solid tumors. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Fuzzy Mixed Assembly Line Sequencing and Scheduling Optimization Model Using Multiobjective Dynamic Fuzzy GA

PubMed Central

Tahriri, Farzad; Dawal, Siti Zawiah Md; Taha, Zahari

2014-01-01

A new multiobjective dynamic fuzzy genetic algorithm is applied to solve a fuzzy mixed-model assembly line sequencing problem in which the primary goals are to minimize the total make-span and minimize the setup number simultaneously. Trapezoidal fuzzy numbers are implemented for variables such as operation and travelling time in order to generate results with higher accuracy and representative of real-case data. An improved genetic algorithm called fuzzy adaptive genetic algorithm (FAGA) is proposed in order to solve this optimization model. In establishing the FAGA, five dynamic fuzzy parameter controllers are devised in which fuzzy expert experience controller (FEEC) is integrated with automatic learning dynamic fuzzy controller (ALDFC) technique. The enhanced algorithm dynamically adjusts the population size, number of generations, tournament candidate, crossover rate, and mutation rate compared with using fixed control parameters. The main idea is to improve the performance and effectiveness of existing GAs by dynamic adjustment and control of the five parameters. Verification and validation of the dynamic fuzzy GA are carried out by developing test-beds and testing using a multiobjective fuzzy mixed production assembly line sequencing optimization problem. The simulation results highlight that the performance and efficacy of the proposed novel optimization algorithm are more efficient than the performance of the standard genetic algorithm in mixed assembly line sequencing model. PMID:24982962

A Clinical Nutrition Course to Improve Pharmacy Students' Skills and Confidence in Counseling Patients

PubMed Central

Popovich, Nicholas G.; Iramaneerat, Cherdsak; Smith, Everett V.; Lutfiyya, M. Nawal

2008-01-01

Objective To create, implement, and evaluate a PharmD course on primary care nutrition. Design A 2-credit hour elective course was offered to second- and third-year pharmacy students. It was informed by the Socratic method using a minimum number of formal lecture presentations and featured problem-based learning exercises, case-based scenarios, and scientific literature to fuel informed debate. A single group posttest design with a retrospective pretest was used to assess students' self-efficacy. Assessment There was a significant overall improvement in students' self-efficacy in their ability to practice primary care nutrition. Conclusion Completion of a nutrition course improved students' confidence in providing primary care nutrition and empowered them to speak more comfortably about the role of nutrition in the prevention of chronic diseases. PMID:18698396

Rhodiola rosea therapy for major depressive disorder: a study protocol for a randomized, double-blind, placebo- controlled trial

PubMed Central

Mao, Jun J; Li, Qing S.; Soeller, Irene; Xie, Sharon X; Amsterdam, Jay D.

2014-01-01

Background Rhodiola rosea (R. rosea), a botanical of both western and traditional Chinese medicine, has been used as a folk remedy for improving stamina and reducing stress. However, few controlled clinical trials have examined the safety and efficacy of R. rosea for the treatment of major depressive disorder (MDD). This study seeks to evaluate the safety and efficacy of R. rosea in a 12-week, randomized, double-blind, placebo-controlled, parallel group study design. Methods / Design Subjects with MDD not receiving antidepressant therapy will be randomized to either R. rosea extract 340–1,360 mg daily; sertraline 50–200 mg daily, or placebo for 12 weeks. The primary outcome measure will be change over time in the mean 17-item Hamilton Depression Rating score. Secondary outcome measures will include safety and quality of life ratings. Statistical procedures will include mixed-effects models to assess efficacy for primary and secondary outcomes. Discussion This study will provide valuable preliminary information on the safety and efficacy data of R. rosea versus conventional antidepressant therapy of MDD. It will also inform additional hypotheses and study design of future, fully powered, phase III clinical trials with R. rosea to determine its safety and efficacy in MDD. PMID:25610752

A meta-analysis of the efficacy of fibromyalgia treatment according to level of care

PubMed Central

Garcia-Campayo, Javier; Magdalena, Jesus; Magallón, Rosa; Fernández-García, Esther; Salas, Montserrat; Andrés, Eva

2008-01-01

Introduction The aim of this paper was to compare the efficacy of the treatments for fibromyalgia currently available in both primary care and specialised settings. Methods Published reports of randomised controlled trials (RCTs) researching pharmacological and non-pharmacological treatments in patients with fibromyalgia were found in the MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and PsychInfo databases. The most recent electronic search was undertaken in June 2006. Results We identified a total of 594 articles. Based on titles and abstracts, 102 full articles were retrieved, 33 of which met the inclusion criteria. These RCTs assessed 120 treatment interventions in 7789 patients diagnosed with primary fibromyalgia. Of them, 4505 (57.8%) were included in the primary care group of our study and 3284 (42.2%) in the specialised intervention group. The sample was mostly made up of middle-aged women, who have had fibromyalgia for a mean period of 6 to 10 years. The mean effect size of the efficacy of the 120 treatment interventions in patients with fibromyalgia compared with controls was 0.49 (95% confidence interval [CI] = 0.39 to 0.58; p < 0.001). In the primary care group it was 0.46 (95% CI = 0.33 to 0.58) while in specialised care it was 0.53 (95% CI = 0.38 to 0.69), with no statistical significance in the differences. We analysed the efficacy of treatments by comparing primary and specialised care in the different fibromyalgia groups and there were no significant differences. The variables of the studies that affected the improvements in the efficacy of fibromyalgia treatment were low quality of the studies and a shorter duration of treatment. However, both factors were biased by the heterogeneity of the studies. Other variables that also improved outcome and were not biased by the heterogeneity of the studies, were younger age of the patients and shorter duration of the disorder. On the contrary, gender and type of treatment (pharmacological vs. psychological) did not affect outcome. Conclusion Based on this meta-analysis and despite the heterogeneity of specialised care studies and of the other limitations described in this article, treating fibromyalgia in specialised care offers no clear advantages. PMID:18627602

Study protocol for a pragmatic randomised controlled trial evaluating efficacy of a smoking cessation e-'Tabac Info Service': ee-TIS trial.

PubMed

Cambon, L; Bergman, P; Le Faou, Al; Vincent, I; Le Maitre, B; Pasquereau, A; Arwidson, P; Thomas, D; Alla, F

2017-02-24

A French national smoking cessation service, Tabac Info Service, has been developed to provide an adapted quitline and a web and mobile application involving personalised contacts (eg, questionnaires, advice, activities, messages) to support smoking cessation. This paper presents the study protocol of the evaluation of the application (e-intervention Tabac Info Service (e-TIS)). The primary objective is to assess the efficacy of e-TIS. The secondary objectives are to (1) describe efficacy variations with regard to users' characteristics, (2) analyse mechanisms and contextual conditions of e-TIS efficacy. The study design is a two-arm pragmatic randomised controlled trial including a process evaluation with at least 3000 participants randomised to the intervention or to the control arm (current practices). Inclusion criteria are: aged 18 years or over, current smoker, having completed the online consent forms, possessing a mobile phone with android or apple systems and using mobile applications, wanting to stop smoking sooner or later. The primary outcome is the point prevalence abstinence of 7 days at 6 months later. Data will be analysed in intention to treat (primary) and per protocol analyses. A logistic regression will be carried out to estimate an OR (95% CI) for efficacy. A multivariate multilevel analysis will explore the influence on results of patients' characteristics (sex, age, education and socioprofessional levels, dependency, motivation, quit experiences) and contextual factors, conditions of use, behaviour change techniques. The study protocol was reviewed by the ethical and deontological institutional review board of the French Institute for Public Health Surveillance on 18 April 2016. The findings of this study will allow us to characterise the efficacy of e-TIS and conditions of its efficacy. These findings will be disseminated through peer-reviewed articles. NCT02841683; Pre-results. 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/.

Extrapolating theoretical efficacy of inactivated influenza A/H5N1 virus vaccine from human immunogenicity studies

PubMed Central

Feldstein, Leora R.; Matrajt, Laura; Halloran, M. Elizabeth; Keitel, Wendy A.; Longini, Ira M.

2016-01-01

Influenza A virus subtype H5N1 has been a public health concern for almost 20 years due to its potential ability to become transmissible among humans. Phase I and II clinical trials have assessed safety, reactogenicity and immunogenicity of inactivated influenza A/H5N1 virus vaccines. A shortage of vaccine is likely to occur during the first months of a pandemic. Hence, determining whether to give one dose to more people or two doses to fewer people to best protect the population is essential. We use hemagglutination-inhibition antibody titers as an immune correlate for avian influenza vaccines. Using an established relationship to obtain a theoretical vaccine efficacy from immunogenicity data from thirteen arms of six phase I and phase II clinical trials of inactivated influenza A/H5N1 virus vaccines, we assessed: 1) the proportion of theoretical vaccine efficacy achieved after a single dose (defined as primary response level), and 2) whether theoretical efficacy increases after a second dose, with and without adjuvant. Participants receiving vaccine with AS03 adjuvant had higher primary response levels (range: 0.48–0.57) compared to participants receiving vaccine with MF59 adjuvant (range: 0.32–0.47), with no observed trends in primary response levels by antigen dosage. After the first and second doses, vaccine with AS03 at dosage levels 3.75, 7.5 and 15 mcg had the highest estimated theoretical vaccine efficacy: Dose 1) 45% (95%CI: 36–57%), 53% (95%CI: 42–63%) and 55% (95%CI: 44–64%), respectively and Dose 2) 93% (95%CI: 89–96%), 97% (95%CI: 95–98%) and 97% (95%CI: 96–100%), respectively. On average, the estimated theoretical vaccine efficacy of lower dose adjuvanted vaccines (AS03 and MF59) was 17% higher than that of higher dose unadjuvanted vaccines, suggesting that including an adjuvant is dose-sparing. These data indicate adjuvanted inactivated influenza A/H5N1 virus vaccine produces high theoretical efficacy after two doses to protect individuals against a potential avian influenza pandemic. PMID:27268778

A comprehensive study on regulatory requirements for development and filing of generic drugs globally

PubMed Central

Handoo, Shweta; Arora, Vandana; Khera, Deepak; Nandi, Prafulla Kumar; Sahu, Susanta Kumar

2012-01-01

The regulatory requirements of various countries of the world vary from each other. Therefore, it is challenging for the companies to develop a single drug which can be simultaneously submitted in all the countries for approval. The regulatory strategy for product development is essentially to be established before commencement of developmental work in order to avoid major surprises after submission of the application. The role of the regulatory authorities is to ensure the quality, safety, and efficacy of all medicines in circulation in their country. It not only includes the process of regulating and monitoring the drugs but also the process of manufacturing, distribution, and promotion of it. One of the primary challenges for regulatory authority is to ensure that the pharmaceutical products are developed as per the regulatory requirement of that country. This process involves the assessment of critical parameters during product development. PMID:23373001

Update on cryotherapy for localized prostate cancer.

PubMed

Ritch, Chad R; Katz, Aaron E

2009-05-01

Stage migration has led to an increased incidence of localized and low-risk prostate cancer. Intermediate-term data are emerging on the efficacy of cryotherapy, but direct comparison to other therapeutic modalities is difficult as the parameters for recurrence are not well defined. Studies using the American Society for Therapeutic Radiation and Oncology and the Phoenix (nadir plus 2) criteria for biochemical recurrence show that primary cryotherapy appears to be comparable for low-risk prostate cancer as other treatment modalities. In addition, health-related quality-of-life measures have improved with the most recent third-generation systems demonstrating low incontinence and urethrorectal fistula rates. Erectile dysfunction is high with whole gland ablation, but focal therapy may reduce these rates while still ablating unilateral cancerous tissue. Prostate cryotherapy for localized prostate cancer is an evolving but viable therapeutic option. Long-term data are still needed to establish a definitive role for cryosurgery in prostate cancer treatment.

Intra-arterial brachytherapy of hepatic malignancies: watch the flow.

PubMed

Morgan, Bruno; Kennedy, Andrew S; Lewington, Val; Jones, Bleddyn; Sharma, Ricky A

2011-02-01

Although the liver possesses a dual blood supply, arterial vessels deliver only a small proportion of blood to normal parenchyma, but they deliver the vast majority of blood to primary and secondary cancers of the liver. This anatomical discrepancy is the basis for intra-arterial brachytherapy of liver cancers using radioactive microspheres, termed radio-embolization (RE). Radioactive microspheres implant preferentially in the terminal arterioles of tumors. Although biological models of the flow dynamics and distribution of microspheres are currently in development, there is a need to improve the imaging biomarkers of flow dynamics used to plan RE. Since a direct consequence of RE is vascular disruption and necrosis, we suggest that imaging protocols sensitive to changes in vasculature are highly likely to represent useful early biomarkers for treatment efficacy. We propose dynamic contrast-enhanced CT as the most appropriate imaging modality for studying vascular parameters in clinical trials of RE treatment.

Effects of Continuous Positive Airway Pressure on Neurocognitive Function in Obstructive Sleep Apnea Patients: The Apnea Positive Pressure Long-term Efficacy Study (APPLES)

PubMed Central

Kushida, Clete A.; Nichols, Deborah A.; Holmes, Tyson H.; Quan, Stuart F.; Walsh, James K.; Gottlieb, Daniel J.; Simon, Richard D.; Guilleminault, Christian; White, David P.; Goodwin, James L.; Schweitzer, Paula K.; Leary, Eileen B.; Hyde, Pamela R.; Hirshkowitz, Max; Green, Sylvan; McEvoy, Linda K.; Chan, Cynthia; Gevins, Alan; Kay, Gary G.; Bloch, Daniel A.; Crabtree, Tami; Dement, William C.

2012-01-01

Study Objective: To determine the neurocognitive effects of continuous positive airway pressure (CPAP) therapy on patients with obstructive sleep apnea (OSA). Design, Setting, and Participants: The Apnea Positive Pressure Long-term Efficacy Study (APPLES) was a 6-month, randomized, double-blind, 2-arm, sham-controlled, multicenter trial conducted at 5 U.S. university, hospital, or private practices. Of 1,516 participants enrolled, 1,105 were randomized, and 1,098 participants diagnosed with OSA contributed to the analysis of the primary outcome measures. Intervention: Active or sham CPAP Measurements: Three neurocognitive variables, each representing a neurocognitive domain: Pathfinder Number Test-Total Time (attention and psychomotor function [A/P]), Buschke Selective Reminding Test-Sum Recall (learning and memory [L/M]), and Sustained Working Memory Test-Overall Mid-Day Score (executive and frontal-lobe function [E/F]) Results: The primary neurocognitive analyses showed a difference between groups for only the E/F variable at the 2 month CPAP visit, but no difference at the 6 month CPAP visit or for the A/P or L/M variables at either the 2 or 6 month visits. When stratified by measures of OSA severity (AHI or oxygen saturation parameters), the primary E/F variable and one secondary E/F neurocognitive variable revealed transient differences between study arms for those with the most severe OSA. Participants in the active CPAP group had a significantly greater ability to remain awake whether measured subjectively by the Epworth Sleepiness Scale or objectively by the maintenance of wakefulness test. Conclusions: CPAP treatment improved both subjectively and objectively measured sleepiness, especially in individuals with severe OSA (AHI > 30). CPAP use resulted in mild, transient improvement in the most sensitive measures of executive and frontal-lobe function for those with severe disease, which suggests the existence of a complex OSA-neurocognitive relationship. Clinical Trial Information: Registered at clinicaltrials.gov. Identifier: NCT00051363. Citation: Kushida CA; Nichols DA; Holmes TH; Quan SF; Walsh JK; Gottlieb DJ; Simon RD; Guilleminault C; White DP; Goodwin JL; Schweitzer PK; Leary EB; Hyde PR; Hirshkowitz M; Green S; McEvoy LK; Chan C; Gevins A; Kay GG; Bloch DA; Crabtree T; Demen WC. Effects of continuous positive airway pressure on neurocognitive function in obstructive sleep apnea patients: the Apnea Positive Pressure Long-term Efficacy Study (APPLES). SLEEP 2012;35(12):1593-1602. PMID:23204602

Safety and hemostatic efficacy of fibrin pad in partial nephrectomy: Results of an open-label Phase I and a randomized, standard-of-care-controlled Phase I/II study

PubMed Central

2012-01-01

Background Bleeding severity, anatomic location, tissue characteristics, and visibility are common challenges encountered while managing intraoperative bleeding, and conventional hemostatic measures (suture, ligature, and cautery) may sometimes be ineffective or impractical. While topical absorbable hemostats (TAH) are useful hemostatic adjuvants, each TAH has associated disadvantages. Methods We evaluated the safety and hemostatic efficacy of a new advanced biologic combination product―fibrin pad―to potentially address some gaps associated with TAHs. Fibrin pad was assessed as adjunctive hemostat in open partial nephrectomy in single-center, open-label, Phase I study (N = 10), and as primary hemostat in multicenter, single-blind, randomized, standard-of-care (SOC)-controlled Phase I/II study (N = 7) in Israel. It was used to control mild-to-moderate bleeding in Phase I and also spurting arterial bleeding in Phase I/II study. Phase I study assessed safety and Phase I/II study, proportion of successes at 10 min following randomization, analyzed by Fisher exact tests at 5% significance level. Results Phase I (N = 10): All patients completed the study. Hemostasis was achieved within 3–4 min (average = 3.1 min) of a single application in all patients. Fibrin pad was found to be safe for human use, with no product-related adverse events reported. Phase I/II (N = 7): Hemostatic success at 10 min (primary endpoint) was achieved in 3/4 patients treated with fibrin pad versus 0/3 patients treated with SOC. No clinically significant change in laboratory or coagulation parameters was recorded, except a case of post-procedural hemorrhage with fibrin pad, which was considered serious and related to the fibrin pad treatment, and required re-operation. Although Data Safety Monitoring Board authorized trial continuation, the sponsor decided against proceeding toward an indication for primary treatment of severe arterial hemorrhage as a replacement for sutures. The study was suspended after 7/30 planned subjects were enrolled. Conclusions The first-in-man trial of fibrin pad demonstrated its safety and efficacy as an adjunctive hemostatic technique for mild-to-moderate bleeding in partial nephrectomy. The study also suggested that the product should not replace sutures or meticulous surgical techniques for the treatment of severe arterial hemorrhage. Trial registration Phase I/II trial, NCT00598130 PMID:23137020

The Leeds Evaluation of Efficacy of Detoxification Study (LEEDS) project: an open-label pragmatic randomised control trial comparing the efficacy of differing therapeutic agents for primary care detoxification from either street heroin or methadone [ISRCTN07752728].

PubMed

Oldham, Nicola S; Wright, Nat M J; Adams, Clive E; Sheard, Laura; Tompkins, Charlotte N E

2004-04-29

Heroin is a synthetic opioid with an extensive illicit market leading to large numbers of people becoming addicted. Heroin users often present to community treatment services requesting detoxification and in the UK various agents are used to control symptoms of withdrawal. Dissatisfaction with methadone detoxification 8 has lead to the use of clonidine, lofexidine, buprenorphine and dihydrocodeine; however, there remains limited evaluative research. In Leeds, a city of 700,000 people in the North of England, dihydrocodeine is the detoxification agent of choice. Sublingual buprenorphine, however, is being introduced. The comparative value of these two drugs for helping people successfully and comfortably withdraw from heroin has never been compared in a randomised trial. Additionally, there is a paucity of research evaluating interventions among drug users in the primary care setting. This study seeks to address this by randomising drug users presenting in primary care to receive either dihydrocodeine or buprenorphine. The Leeds Evaluation of Efficacy of Detoxification Study (LEEDS) project is a pragmatic randomised trial which will compare the open use of buprenorphine with dihydrocodeine for illicit opiate detoxification, in the UK primary care setting. The LEEDS project will involve consenting adults and will be run in specialist general practice surgeries throughout Leeds. The primary outcome will be the results of a urine opiate screening at the end of the detoxification regimen. Adverse effects and limited data to three and six months will be acquired.

Preliminary examination of the efficacy and safety of a standardized chamomile extract for chronic primary insomnia: a randomized placebo-controlled pilot study.

PubMed

Zick, Suzanna M; Wright, Benjamin D; Sen, Ananda; Arnedt, J Todd

2011-09-22

Despite being the most commonly used herbal for sleep disorders, chamomile's (Matricaria recutita) efficacy and safety for treating chronic primary insomnia is unknown. We examined the preliminary efficacy and safety of chamomile for improving subjective sleep and daytime symptoms in patients with chronic insomnia. We performed a randomized, double-blind, placebo-controlled pilot trial in 34 patients aged 18-65 years with DSM-IV primary insomnia for ≥ 6-months. Patients were randomized to 270 mg of chamomile twice daily or placebo for 28-days. The primary outcomes were sleep diary measures. Secondary outcomes included daytime symptoms, safety assessments, and effect size of these measures. There were no significant differences between groups in changes in sleep diary measures, including total sleep time (TST), sleep efficiency, sleep latency, wake after sleep onset (WASO), sleep quality, and number of awakenings. Chamomile did show modest advantage on daytime functioning, although these did not reach statistical significance. Effect sizes were generally small to moderate (Cohen's d ≤ 0.20 to < 0.60) with sleep latency, night time awakenings, and Fatigue Severity Scale (FSS), having moderate effect sizes in favor of chamomile. However, TST demonstrated a moderate effect size in favor of placebo. There were no differences in adverse events reported by the chamomile group compared to placebo. Chamomile could provide modest benefits of daytime functioning and mixed benefits on sleep diary measures relative to placebo in adults with chronic primary insomnia. However, further studies in select insomnia patients would be needed to investigate these conclusions.

Nano-hydroxyapatite and calcium-enriched mixture for pulp capping of sound primary teeth: a randomized clinical trial.

PubMed

Haghgoo, Roza; Asgary, Saeed; Mashhadi Abbas, Fatemeh; Montazeri Hedeshi, Roshanak

2015-01-01

Nano-hydroxyapatite (NHA) has been used for regeneration of osseous defects. Calcium-enriched mixture (CEM) cement is also used for various dental treatments. This trial compared the efficacy of NHA and CEM cement for direct pulp capping (DPC) of sound primary teeth. In this randomized clinical trial with split-mouth design, after attaining informed consent, 20 sound primary canines scheduled for orthodontic extraction, were selected. After mechanical pulp exposure, the exposed site was capped with either NHA or CEM cement and then immediately restored with glass-ionomer and resin composite. The teeth were extracted after two months and examined histologically. Parameters of hard tissue bridge (HTB) formation, its type and quality as well as pulpal inflammation scores were compared between the two experimental groups. The data were analyzed using the Mann Whitney U and Fisher's exact test. The level of significance was set at 0.001. All CEM specimens showed inflammation score of 0 (less than 10%). However, in NHA group, inflammation scores of 0 (less than 10%), 1 (10%-30%) and 2 (30%-50%) were observed in 2 (20%), 4 (40%) and 4 (40%) specimens, respectively (P<0.001). HTB was formed in all CEM specimens while it was developed in 2 specimens of NHA (20%; P<0.001). All CEM specimens showed normal pulp; only two cases in NHA group (20%) demonstrated uninflamed normal pulp. CEM cement was superior to NHA as a DPC agent in terms of HTB formation and pulp inflammation scores. It is a suitable material for the DPC of primary teeth.

A randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of venlafaxine extended release and a long-term extension study for patients with major depressive disorder in Japan.

PubMed

Higuchi, Teruhiko; Kamijima, Kunitoshi; Nakagome, Kazuyuki; Itamura, Rio; Asami, Yuko; Kuribayashi, Kazuhiko; Imaeda, Takayuki

2016-01-01

The aim of this study was to assess antidepressant efficacy and safety of venlafaxine extended release in Japanese patients with major depressive disorder (MDD). We carried out a double-blinded, placebo-controlled, randomized study using fixed (75 mg/day) and flexible (75-225 mg/day, most patients attained to 225 mg/day) doses, followed by the long-term, open-labeled, extension study. Outpatients aged at least 20 years diagnosed with MDD were included. The primary efficacy measure was change from baseline in the Hamilton Rating Scale for Depression (HAM-D17) score at week 8; secondary efficacy measures included the Montgomery-Åsberg Depression Rating Scale, the Quick Inventory of Depressive Symptomatology self-report version, HAM-D6, and Clinical Global Impression scales in the double-blinded study. Overall, 538 patients were randomized; significant differences were observed in the primary efficacy variable in the fixed-dose group (-10.76; P=0.031), but not in the flexible-dose (-10.37; P=0.106) group compared with placebo (-9.25). However, the flexible-dose group showed significant efficacy in several secondary measures. Treatment-related adverse events in the treatment period were 51.7 and 67.8% in the fixed-dose and flexible-dose groups, respectively, versus 38.8% with placebo. Throughout the study period, no Japanese-specific adverse events were observed. Thus, venlafaxine extended release was efficacious and safe for MDD treatment in Japan.

A randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of venlafaxine extended release and a long-term extension study for patients with major depressive disorder in Japan

PubMed Central

Higuchi, Teruhiko; Kamijima, Kunitoshi; Nakagome, Kazuyuki; Asami, Yuko; Kuribayashi, Kazuhiko; Imaeda, Takayuki

2016-01-01

The aim of this study was to assess antidepressant efficacy and safety of venlafaxine extended release in Japanese patients with major depressive disorder (MDD). We carried out a double-blinded, placebo-controlled, randomized study using fixed (75 mg/day) and flexible (75–225 mg/day, most patients attained to 225 mg/day) doses, followed by the long-term, open-labeled, extension study. Outpatients aged at least 20 years diagnosed with MDD were included. The primary efficacy measure was change from baseline in the Hamilton Rating Scale for Depression (HAM-D17) score at week 8; secondary efficacy measures included the Montgomery–Åsberg Depression Rating Scale, the Quick Inventory of Depressive Symptomatology self-report version, HAM-D6, and Clinical Global Impression scales in the double-blinded study. Overall, 538 patients were randomized; significant differences were observed in the primary efficacy variable in the fixed-dose group (−10.76; P=0.031), but not in the flexible-dose (−10.37; P=0.106) group compared with placebo (−9.25). However, the flexible-dose group showed significant efficacy in several secondary measures. Treatment-related adverse events in the treatment period were 51.7 and 67.8% in the fixed-dose and flexible-dose groups, respectively, versus 38.8% with placebo. Throughout the study period, no Japanese-specific adverse events were observed. Thus, venlafaxine extended release was efficacious and safe for MDD treatment in Japan. PMID:26513202

Primary antibiotic resistance in Helicobacter pylori in the Asia-Pacific region: a systematic review and meta-analysis.

PubMed

Kuo, Yu-Ting; Liou, Jyh-Ming; El-Omar, Emad M; Wu, Jeng-Yih; Leow, Alex Hwong Ruey; Goh, Khean Lee; Das, Rajashree; Lu, Hong; Lin, Jaw-Town; Tu, Yu-Kang; Yamaoka, Yoshio; Wu, Ming-Shiang

2017-10-01

So far, a comprehensive systematic review and meta-analysis has not been done of the prevalence of primary antibiotic resistance in Helicobacter pylori in the Asia-Pacific region. We aimed to assess the trends and regional differences in primary antibiotic resistance to H pylori in the Asia-Pacific region and to examine the relation between resistance and first-line eradication. We did a systematic review and meta-analysis of primary antibiotic resistance to H pylori and the efficacy of first-line regimens in the Asia-Pacific region. We searched PubMed, Embase, and the Cochrane Library for articles published between Jan 1, 1990, and Sept 30, 2016; we also searched abstracts from international conferences. Both observational studies and randomised controlled trials were eligible for inclusion in the analysis of primary antibiotic resistance, but only randomised controlled trials were eligible for inclusion in the analysis of efficacy of first-line therapies. Meta-analysis was by the random-effects model to account for the substantial variations in resistance across the region. We did subgroup analyses by country and study period (ie, before 2000, 2001-05, 2006-10, and 2011-15) to establish country-specific prevalences of primary antibiotic resistance and first-line eradication rates. This study is registered with PROSPERO, number CRD42017057905. 176 articles from 24 countries were included in our analysis of antibiotic resistance. The overall mean prevalences of primary H pylori resistance were 17% (95% CI 15-18) for clarithromycin, 44% (95% CI 39-48) for metronidazole, 18% (95% CI 15-22) for levofloxacin, 3% (95% CI 2-5) for amoxicillin, and 4% (95% CI 2-5) for tetracycline. Prevalence of resistance to clarithromycin and levofloxacin rose significantly over time during the period investigated, whereas resistance to other antibiotics remained stable. 170 articles from 16 countries were included in analysis of efficacy of first-line therapies. We noted unsatisfactory efficacy (ie, <80%) with clarithromycin-containing regimens in countries where the clarithromycin resistance rates were higher than 20%. The prevalence of primary antibiotic resistance varied greatly among countries in the Asia-Pacific region, and thus treatment strategy should be adapted relative to country-specific resistance patterns. Clarithromycin-containing regimens should be avoided in countries where the prevalence of clarithromycin resistance is higher than 20%. Ministry of Health and Welfare of Taiwan, Ministry of Science and Technology of Taiwan, and Amity University. Copyright © 2017 Elsevier Ltd. All rights reserved.

Safety and preliminary efficacy of deep transcranial magnetic stimulation in MS-related fatigue

PubMed Central

Gaede, Gunnar; Tiede, Marina; Lorenz, Ina; Brandt, Alexander U.; Pfueller, Caspar; Dörr, Jan; Bellmann-Strobl, Judith; Piper, Sophie K.; Roth, Yiftach; Zangen, Abraham; Schippling, Sven

2017-01-01

Objective: To conduct a randomized, sham-controlled phase I/IIa study to evaluate the safety and preliminary efficacy of deep brain H-coil repetitive transcranial magnetic stimulation (rTMS) over the prefrontal cortex (PFC) and the primary motor cortex (MC) in patients with MS with fatigue or depression (NCT01106365). Methods: Thirty-three patients with MS were recruited to undergo 18 consecutive rTMS sessions over 6 weeks, followed by follow-up (FU) assessments over 6 weeks. Patients were randomized to receive high-frequency stimulation of the left PFC, MC, or sham stimulation. Primary end point was the safety of stimulation. Preliminary efficacy was assessed based on changes in Fatigue Severity Scale (FSS) and Beck Depression Inventory scores. Randomization allowed only analysis of preliminary efficacy for fatigue. Results: No serious adverse events were observed. Five patients terminated participation during treatment due to mild side effects. Treatment resulted in a significant median FSS decrease of 1.0 point (95%CI [0.45,1.65]), which was sustained during FU. Conclusions: H-coil rTMS is safe and well tolerated in patients with MS. The observed sustained reduction in fatigue after subthreshold MC stimulation warrants further investigation. ClinicalTrials.gov identifier: NCT01106365. Classification of evidence: This study provides Class III evidence that rTMS of the prefrontal or primary MC is not associated with serious adverse effects, although this study is underpowered to state this with any precision. PMID:29259998

The efficacy of cognitive behavioral therapy for Chinese people: A meta-analysis.

PubMed

Ng, Ting Kin; Wong, Daniel Fu Keung

2018-07-01

Over the past decade, cognitive behavioral therapy has been applied to an increasingly wider range of disorders and problems in Chinese societies. However, no meta-analysis has been conducted to synthesize the studies on cognitive behavioral therapy for Chinese clients. The purpose of this meta-analytic study was to examine the overall efficacy of cognitive behavioral therapy for Chinese people. A literature search was conducted using electronic databases, including Web of Science, PsycINFO and PubMed. Pooled mean effect sizes were calculated using the random-effects model. The literature search identified 55 studies with 6763 Chinese participants. The overall short-term effect of cognitive behavioral therapy on the primary outcome was medium in size. Effect sizes were medium for anxiety, depression/well-being and caregiving stress and small for psychotic symptoms and addictive behaviors. The effects of cognitive behavioral therapy on process variables, dysfunctional thoughts and coping, were in the small range. The overall longer-term effect of cognitive behavioral therapy on the primary outcome was medium in size. Moderator analyses showed that the short-term effect was stronger for culturally adapted cognitive behavioral therapy than for unadapted cognitive behavioral therapy. Type of primary outcome, type of control group, recruitment method, study design, the format of delivery and region were found to moderate the efficacy of cognitive behavioral therapy. The findings of this study provide evidence for the overall efficacy of cognitive behavioral therapy for Chinese people and the benefit of cultural adaptation of cognitive behavioral therapy to Chinese culture.

Antecedents of Mathematics Self-Efficacy Beliefs for Middle and High School Students: An Instrument Validation Study

ERIC Educational Resources Information Center

Freed, Mark R.

2013-01-01

There were three primary purposes for this study. First, I investigated the psychometric properties of the Sources of Middle School Mathematics Self-Efficacy (SMMSE) scale (Usher, 2007; Usher & Pajares, 2009) with high school students. Validation for expanded use of the SMMSE scale was achieved by assessing the instrument's psychometric…

The Effects of Positive Behavior Intervention and Supports on Teacher Self-Efficacy and Teaching Anxiety

ERIC Educational Resources Information Center

VanParys Couet, Jill M.

2014-01-01

Positive Behavior Intervention and Supports (PBIS) is a process designed to improve disruptive behavior and increase student's achievement at the primary and secondary level. Although the success of PBIS programs with student achievement is well documented, the impact of PBIS on teachers' teaching anxiety and self-efficacy levels has yet to be…

Teacher Stress, Teaching-Efficacy, and Job Satisfaction in Response to Test-Based Educational Accountability Policies

ERIC Educational Resources Information Center

von der Embse, Nathaniel P.; Sandilos, Lia E.; Pendergast, Laura; Mankin, Ariel

2016-01-01

Educator stress has been linked to decreased job satisfaction, negative instructional practices, and poor student outcomes. However, it is unknown whether educators with high teaching efficacy may better cope with the test stress. As such, the primary purpose of the present investigation was to examine the complex relationship between teacher…

Self-Efficacy of Prospective Austrian and German Primary School Teachers Regarding the Implementation of Inclusive Education

ERIC Educational Resources Information Center

Schwab, Susanne; Hellmich, Frank; Görel, Gamze

2017-01-01

This study examined the psychometric properties of the German version of the Teacher Inclusive Education Self-Efficacy Scale (TIESES). Five hundred and nineteen teacher education students from Austria and 765 teacher education students from Germany participated in the study. Results of a multiple-group confirmatory factor analysis (for the two…

Primary School Teachers' Levels of Self-Efficacy According to Various Settlement Areas

ERIC Educational Resources Information Center

Erdemir, Naki

2011-01-01

The purpose of this study was to determine how elementary teachers use computers, the Internet, and educational technology in the educational process. The purpose was also to gain information regarding the teachers' possession of technological devices and their levels of self-efficacy in using them among the different types of settlement areas.…

Efficacy of Cognitive-Behavioral Therapy for Comorbid Panic Disorder with Agoraphobia and Generalized Anxiety Disorder

ERIC Educational Resources Information Center

Labrecque, Joane; Marchand, Andre; Dugas, Michel J.; Letarte, Andree

2007-01-01

The goal of this study was to evaluate the efficacy of cognitive-behavioral therapy for comorbid panic disorder with agoraphobia (PDA) and generalized anxiety disorder (GAD) by combining treatment strategies for both disorders. A single-case, multiple-baseline design across participants was used. Three participants with primary PDA and secondary…

Cognitive-Behavioral Therapy for Comorbid Generalized Anxiety Disorder and Panic Disorder with Agoraphobia

ERIC Educational Resources Information Center

Labrecque, Joane; Dugas, Michel J.; Marchand, Andre; Letarte, Andree

2006-01-01

The goal of this study was to evaluate the efficacy of a cognitive-behavioral treatment package for comorbid generalized anxiety disorder (GAD) and panic disorder with agoraphobia (PDA). A single-case, multiple-baseline, across-subjects design was used with 3 primary GAD patients with secondary PDA. The efficacy of the treatment was evaluated with…

Preparing Preservice Teachers for Inclusive Classrooms: Does Completing Coursework on Managing Challenging Behaviours Increase Their Classroom Management Sense of Efficacy?

ERIC Educational Resources Information Center

O'Neill, Sue C.

2015-01-01

Preservice teacher education courses provide an opportunity for the development of knowledge, skills, and confidence in classroom and behaviour management. This study reports the change in classroom management sense of efficacy (CMSE) of a small cohort of Australian preservice primary teachers at 4 time points (precoursework, preprofessional…

Testing the Efficacy of "INSIGHTS" on Student Disruptive Behavior, Classroom Management, and Student Competence in Inner City Primary Grades

ERIC Educational Resources Information Center

McClowry, Sandra Graham; Snow, David L.; Tamis-LeMonda, Catherine S.; Rodriguez, Eileen T.

2010-01-01

A prevention trial tested the efficacy of "INSIGHTS into Children's Temperament" as compared to a Read Aloud attention control condition in reducing student disruptive behavior and enhancing student competence and teacher classroom management. Participants included 116 first and second grade students, their parents, and their 42 teachers…

An Investigation of Music Teaching Self-Efficacy Levels of Prospective Preschool Teachers

ERIC Educational Resources Information Center

Koca, Sehriban

2013-01-01

The aim of the study is to investigate music teaching self-efficacy levels of prospective preschool teachers. The study used survey model. Participants of the study consisted of a total of 120 prospective teachers studying at Mersin University, Faculty of Education, Department of Primary Education Preschool Teaching Program in Mersin, a City in…

Efficacy of a cognitive and behavioural psychotherapy applied by primary care psychologists in patients with mixed anxiety-depressive disorder: a research protocol.

PubMed

Jauregui, Amale; Ponte, Joaquín; Salgueiro, Monika; Unanue, Saloa; Donaire, Carmen; Gómez, Maria Cruz; Burgos-Alonso, Natalia; Grandes, Gonzalo

2015-03-20

In contrast with the recommendations of clinical practice guidelines, the most common treatment for anxiety and depressive disorders in primary care is pharmacological. The aim of this study is to assess the efficacy of a cognitive-behavioural psychological intervention, delivered by primary care psychologists in patients with mixed anxiety-depressive disorder compared to usual care. This is an open-label, multicentre, randomized, and controlled study with two parallel groups. A random sample of 246 patients will be recruited with mild-to-moderate mixed anxiety-depressive disorder, from the target population on the lists of 41 primary care doctors. Patients will be randomly assigned to the intervention group, who will receive standardised cognitive-behavioural therapy delivered by psychologists together with usual care, or to a control group, who will receive usual care alone. The cognitive-behavioural therapy intervention is composed of eight individual 60-minute face-to face sessions conducted in eight consecutive weeks. A follow-up session will be conducted over the telephone, for reinforcement or referral as appropriate, 6 months after the intervention, as required. The primary outcome variable will be the change in scores on the Short Form-36 General Health Survey. We will also measure the change in the frequency and intensity of anxiety symptoms (State-Trait Anxiety Inventory) and depression (Beck Depression Inventory) at baseline, and 3, 6 and 12 months later. Additionally, we will collect information on the use of drugs and health care services. The aim of this study is to assess the efficacy of a primary care-based cognitive-behavioural psychological intervention in patients with mixed anxiety-depressive disorder. The international scientific evidence has demonstrated the need for psychologists in primary care. However, given the differences between health policies and health services, it is important to test the effect of these psychological interventions in our geographical setting. NCT01907035 (July 22, 2013).

Functional characterization of GABAA receptor-mediated modulation of cortical neuron network activity in microelectrode array recordings.

PubMed

Bader, Benjamin M; Steder, Anne; Klein, Anders Bue; Frølund, Bente; Schroeder, Olaf H U; Jensen, Anders A

2017-01-01

The numerous γ-aminobutyric acid type A receptor (GABAAR) subtypes are differentially expressed and mediate distinct functions at neuronal level. In this study we have investigated GABAAR-mediated modulation of the spontaneous activity patterns of primary neuronal networks from murine frontal cortex by characterizing the effects induced by a wide selection of pharmacological tools at a plethora of activity parameters in microelectrode array (MEA) recordings. The basic characteristics of the primary cortical neurons used in the recordings were studied in some detail, and the expression levels of various GABAAR subunits were investigated by western blotting and RT-qPCR. In the MEA recordings, the pan-GABAAR agonist muscimol and the GABABR agonist baclofen were observed to mediate phenotypically distinct changes in cortical network activity. Selective augmentation of αβγ GABAAR signaling by diazepam and of δ-containing GABAAR (δ-GABAAR) signaling by DS1 produced pronounced changes in the majority of the activity parameters, both drugs mediating similar patterns of activity changes as muscimol. The apparent importance of δ-GABAAR signaling for network activity was largely corroborated by the effects induced by the functionally selective δ-GABAAR agonists THIP and Thio-THIP, whereas the δ-GABAAR selective potentiator DS2 only mediated modest effects on network activity, even when co-applied with low THIP concentrations. Interestingly, diazepam exhibited dramatically right-shifted concentration-response relationships at many of the activity parameters when co-applied with a trace concentration of DS1 compared to when applied alone. In contrast, the potencies and efficacies displayed by DS1 at the networks were not substantially altered by the concomitant presence of diazepam. In conclusion, the holistic nature of the information extractable from the MEA recordings offers interesting insights into the contributions of various GABAAR subtypes/subgroups to cortical network activity and the putative functional interplay between these receptors in these neurons.

Efficacy and safety of nebivolol and valsartan as fixed-dose combination in hypertension: a randomised, multicentre study.

PubMed

Giles, Thomas D; Weber, Michael A; Basile, Jan; Gradman, Alan H; Bharucha, David B; Chen, Wei; Pattathil, Manoj

2014-05-31

The fixed-dose combination of any two antihypertensive drugs from different drug classes is typically more effective in reducing blood pressure than a dose increase of component monotherapy. We assessed the efficacy and safety of a fixed-dose combination of a vasodilating β blocker (nebivolol) and an angiotensin II receptor blocker (valsartan) in adults with hypertension. We did an 8-week, phase 3, multicentre, randomised, double-blind, placebo-controlled, parallel-group trial at 401 US sites. Participants (age ≥18 years) with hypertension but with blood pressure less than 180/110 mm Hg were randomly assigned (2:2:2:2:2:2:2:1) by a 24-h interactive web response system in blocks of 15 to 4 weeks of double-blind treatment with nebivolol and valsartan fixed-dose combination (5 and 80 mg/day, 5 and 160 mg/day, or 10 and 160 mg/day), nebivolol (5 mg/day or 20 mg/day), valsartan (80 mg/day or 160 mg/day), or placebo. Doses were doubled in weeks 5-8; results are reported according to the final dose. Participants and research staff were masked to treatment allocation. The primary and key secondary endpoints were changes from baseline to week 8 in diastolic and systolic blood pressure, respectively. The primary statistical comparison was between the highest fixed-dose combination dose and the highest monotherapy doses; lower doses were then compared if this comparison was positive (Hochberg method for multiple testing). Efficacy analyses were by intention to treat. Safety assessments included monitoring of adverse events. Continuous efficacy parameters were analysed using an ANCOVA model; binary outcomes were analysed using a logistic regression model. This study is registered with ClinicalTrials.gov, NCT01508026. Between Jan 6, 2012, and March 15, 2013, 4161 patients were randomly assigned (277 to placebo and 554-555 to each active comparator group), 4118 of whom were included in the primary analysis. At week 8, the fixed-dose combination 20 and 320 mg/day group had significantly greater reductions in diastolic blood pressure from baseline than both nebivolol 40 mg/day (least-squares mean difference -1·2 mm Hg, 95% CI -2·3 to -0·1; p=0·030) and valsartan 320 mg/day (-4·4 mm Hg, -5·4 to -3·3; p<0·0001); all other comparisons were also significant, favouring the fixed-dose combinations (all p<0·0001). All systolic blood pressure comparisons were also significant (all p<0·01). At least one treatment-emergent adverse event was experienced by 30-36% of participants in each group. Nebivolol and valsartan fixed-dose combination is an effective and well-tolerated treatment option for patients with hypertension. Forest Research Institute. Copyright © 2014 Elsevier Ltd. All rights reserved.

Relationship between the clinical efficacy and AUC/MIC of intravenous ciprofloxacin in Japanese patients with intraabdominal infections.

PubMed

Ohki, Emiko; Yamagishi, Yuka; Mikamo, Hiroshige

2013-10-01

The efficacy of fluoroquinolones (FQs) correlates with the pharmacokinetic/pharmacodynamic (PK-PD) parameter, AUC/MIC. To our knowledge, however, no prospective studies have reported the relationship between FQ efficacy and PK-PD parameters in intraabdominal infection; therefore, we prospectively investigated the relationship between the efficacy of intravenous ciprofloxacin (CPFX IV) and PK-PD parameters. The study included 16 patients diagnosed with peritonitis between 2006 and 2008: 14 patients infected with a single organism and 2 patients infected with more than one organism. Each patient was treated with CPFX IV (300 mg twice daily). The response rate was 56% (9 responders and 7 non-responders). Non-responders were infected with Escherichia coli, Pseudomonas aeruginosa, and Bacteroides fragilis (6 patients were infected with a single organism and 1 with more than one organism). Plasma drug concentrations were measured 1 h and 2 or 4 h after administration of CPFX IV. AUC for 24 h (AUC(0-24))/MIC values was calculated. The range of AUC(0-24)/MIC values in responders [95.3-3628.4 (geometric mean, 521.6)] was significantly different from that in non-responders [7.0-45.2 (geometric mean, 16.5)] (p = 0.001). The target AUC/MIC value of CPFX IV would be considered to be 45-95 in patients with peritonitis.

The efficacy of calibrating hydrologic model using remotely sensed evapotranspiration and soil moisture for streamflow prediction

NASA Astrophysics Data System (ADS)

Kunnath-Poovakka, A.; Ryu, D.; Renzullo, L. J.; George, B.

2016-04-01

Calibration of spatially distributed hydrologic models is frequently limited by the availability of ground observations. Remotely sensed (RS) hydrologic information provides an alternative source of observations to inform models and extend modelling capability beyond the limits of ground observations. This study examines the capability of RS evapotranspiration (ET) and soil moisture (SM) in calibrating a hydrologic model and its efficacy to improve streamflow predictions. SM retrievals from the Advanced Microwave Scanning Radiometer-EOS (AMSR-E) and daily ET estimates from the CSIRO MODIS ReScaled potential ET (CMRSET) are used to calibrate a simplified Australian Water Resource Assessment - Landscape model (AWRA-L) for a selection of parameters. The Shuffled Complex Evolution Uncertainty Algorithm (SCE-UA) is employed for parameter estimation at eleven catchments in eastern Australia. A subset of parameters for calibration is selected based on the variance-based Sobol' sensitivity analysis. The efficacy of 15 objective functions for calibration is assessed based on streamflow predictions relative to control cases, and relative merits of each are discussed. Synthetic experiments were conducted to examine the effect of bias in RS ET observations on calibration. The objective function containing the root mean square deviation (RMSD) of ET result in best streamflow predictions and the efficacy is superior for catchments with medium to high average runoff. Synthetic experiments revealed that accurate ET product can improve the streamflow predictions in catchments with low average runoff.

Treatment of primary osteoporosis in men

PubMed Central

Giusti, Andrea; Bianchi, Gerolamo

2015-01-01

With the aging of the population worldwide, osteoporosis and osteoporotic fractures are becoming a serious health care issue in the Western world. Although less frequent than in women, osteoporosis in men is a relatively common problem. Hip and vertebral fractures are particularly relevant, being associated with significant mortality and disability. Since bone loss and fragility fractures in men have been recognized as serious medical conditions, several randomized controlled trials (RCTs) have been undertaken in males with osteoporosis to investigate the anti-fracture efficacy of the pharmacological agents commonly used to treat postmenopausal osteoporosis. Overall, treatments for osteoporosis in men are less defined than in women, mainly due to the fact that there are fewer RCTs performed in male populations, to the relatively smaller sample sizes, and to the lack of long-term extension studies. However, the key question is whether men are expected to respond differently to osteoporosis therapies than women. The pharmacological properties of bisphosphonates, teriparatide, denosumab, and strontium ranelate make such differentiation unlikely, and available clinical data support their efficacy in men with primary osteoporosis as well as in women. In a series of well-designed RCTs, alendronate, risedronate, zoledronic acid, and teriparatide were demonstrated to reduce the risk of new vertebral fractures in men presenting with primary osteoporosis (including osteoporosis associated with low testosterone levels) and to improve the bone mineral density (BMD). In preliminary studies, ibandronate, denosumab, and strontium ranelate also showed their beneficial effects on surrogate outcomes (BMD and markers of bone turnover) in men with osteoporosis. Although direct evidence about their non-vertebral anti-fracture efficacy are lacking, the effects of bisphosphonates, denosumab, teriparatide, and strontium ranelate on surrogate outcomes (BMD and markers of bone turnover) were similar to those reported in pivotal RCTs undertaken in postmenopausal women, in which vertebral and non-vertebral anti-fracture efficacy have been clearly demonstrated. In conclusion, sufficient data exist to support the use of these pharmacological agents in men with primary osteoporosis. Further RCTs are warranted to establish their long-term efficacy and safety. PMID:25565793

Behavior Intervention for Students with Externalizing Behavior Problems: Primary-Level Standard Protocol

ERIC Educational Resources Information Center

Benner, Gregory J.; Nelson, J. Ron; Sanders, Elizabeth A.; Ralston, Nicole C.

2012-01-01

This article examined the efficacy of a primary-level, standard-protocol behavior intervention for students with externalizing behavioral disorders. Elementary schools were randomly assigned to treatment (behavior intervention) or control (business as usual) conditions, and K-3 students were screened for externalizing behavior risk status. The…

Do Local Contributions Affect the Efficacy of Public Primary Schools?

ERIC Educational Resources Information Center

Jimenez, Emmanuel; Paqueo, Vicente

1996-01-01

Uses cost, financial sources, and student achievement data from Philippine primary schools (financed primarily from central sources) to discover if financial decentralization leads to more efficient schools. Schools that rely more heavily on local sources (contributions from local school boards, municipal government, parent-teacher associations,…

Correlation of human papilloma virus status with quantitative perfusion/diffusion/metabolic imaging parameters in the oral cavity and oropharyngeal squamous cell carcinoma: comparison of primary tumour sites and metastatic lymph nodes.

PubMed

Han, M; Lee, S J; Lee, D; Kim, S Y; Choi, J W

2018-05-17

To investigate the differences in perfusion/diffusion/metabolic imaging parameters according to human papilloma virus (HPV) status in the oral cavity and oropharyngeal squamous cell carcinoma (OC-OPSCC), separately in primary tumour sites and metastatic lymph nodes. This retrospective study comprised 41 patients with primary OC-OPSCCs and 29 patients with metastatic lymph nodes. The perfusion/diffusion/metabolic imaging parameters were measured at the primary tumour and the largest ipsilateral metastatic lymph node. The quantitative parameters were compared between the HPV-positive and -negative groups. The HPV-positivity was 39% (16 patients) for the primary tumours and 51.7% (15 patients) for the metastatic lymph nodes. Patients with HPV-positive tumours had a lower T stage (p=0.034). The metastatic lymph nodes for the HPV-positive patients were bulkier (p=0.016) and more frequently had cystic morphology (p=0.005). The perfusion parameters were not different, regardless of HPV status. The diffusion parameter (ADC min , p=0.011) of the metastatic lymph nodes in the HPV-positive groups was lower and metabolic parameter (metabolic tumour volume p=0.035 and total lesion glycolysis p=0.037) were higher than those in HPV-negative groups. The diffusion and metabolic parameters of metastatic lymph nodes from OC-OPSCC were different according to HPV status. The perfusion parameters did not clearly represent HPV status. Copyright © 2018 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.

Optimization of the water chemistry of the primary coolant at nuclear power plants with VVER

DOE Office of Scientific and Technical Information (OSTI.GOV)

Barmin, L. F.; Kruglova, T. K.; Sinitsyn, V. P.

2005-01-15

Results of the use of automatic hydrogen-content meter for controlling the parameter of 'hydrogen' in the primary coolant circuit of the Kola nuclear power plant are presented. It is shown that the correlation between the 'hydrogen' parameter in the coolant and the 'hydrazine' parameter in the makeup water can be used for controlling the water chemistry of the primary coolant system, which should make it possible to optimize the water chemistry at different power levels.

Design of the Intravenous Magnesium Efficacy in Acute Stroke (IMAGES) trial.

PubMed

Bradford, Andrew; Lees, Kennedy

2000-01-01

The Intravenous Magnesium Efficacy in Acute Stroke (IMAGES) trial is a multicentre,randomised, placebo-controlled trial of magnesium sulphate (MgSO4) funded by the UK Medical Research Council. When complete, it will be the largest single neuroprotective study undertaken to date. Conscious patients presenting within 12 h of acute stroke with limb weakness are eligible. The primary outcome measure is combined death and disability as measured using the Barthel Index at 90-day follow up. By randomizing 2700 patients, the study will have 84% power to detect a 5.5% absolute reduction in the primary end-point. By April 2000, 86 centres were participating, with representation in Canada, USA, Europe, South America, Singapore and Australia. So far, 1206 patients have been randomised, of whom 37% were treated within 6 h. Overall 3-month mortality was 20% and the primary outcome event rate was 43%. The study is ongoing and centres worldwide are encouraged to participate.

The efficacy of IntraFlow intraosseous injection as a primary anesthesia technique.

PubMed

Remmers, Todd; Glickman, Gerald; Spears, Robert; He, Jianing

2008-03-01

The purpose of this study was to compare the efficacy of intraosseous injection and inferior alveolar (IA) nerve block in anesthetizing mandibular posterior teeth with irreversible pulpitis. Thirty human subjects were randomly assigned to receive either intraosseous injection using the IntraFlow system (Pro-Dex Inc, Santa Ana, CA) or IA block as the primary anesthesia method. Pulpal anesthesia was evaluated via electric pulp testing at 4-minute intervals for 20 minutes. Two consecutive 80/80 readings were considered successful pulpal anesthesia. Anesthesia success or failure was recorded and groups compared. Intraosseous injection provided successful anesthesia in 13 of 15 subjects (87%). The IA block provided successful anesthesia in 9 of 15 subjects (60%). Although this difference was not statistically significant (p = 0.2148), the results of this preliminary study indicate that the IntraFlow system can be used as the primary anesthesia method in teeth with irreversible pulpitis to achieve predictable pulpal anesthesia.

Economic evaluation of pneumococcal conjugate vaccination in The Gambia.

PubMed

Kim, Sun-Young; Lee, Gene; Goldie, Sue J

2010-09-03

Gambia is the second GAVI support-eligible country to introduce the 7-valent pneumococcal conjugate vaccine (PCV7), but a country-specific cost-effectiveness analysis of the vaccine is not available. Our objective was to assess the potential impact of PCVs of different valences in The Gambia. We synthesized the best available epidemiological and cost data using a state-transition model to simulate the natural histories of various pneumococcal diseases. For the base-case, we estimated incremental cost (in 2005 US dollars) per disability-adjusted life year (DALY) averted under routine vaccination using PCV9 compared to no vaccination. We extended the base-case results for PCV9 to estimate the cost-effectiveness of PCV7, PCV10, and PCV13, each compared to no vaccination. To explore parameter uncertainty, we performed both deterministic and probabilistic sensitivity analyses. We also explored the impact of vaccine efficacy waning, herd immunity, and serotype replacement, as a part of the uncertainty analyses, by assuming alternative scenarios and extrapolating empirical results from different settings. Assuming 90% coverage, a program using a 9-valent PCV (PCV9) would prevent approximately 630 hospitalizations, 40 deaths, and 1000 DALYs, over the first 5 years of life of a birth cohort. Under base-case assumptions ($3.5 per vaccine), compared to no intervention, a PCV9 vaccination program would cost $670 per DALY averted in The Gambia. The corresponding values for PCV7, PCV10, and PCV13 were $910, $670, and $570 per DALY averted, respectively. Sensitivity analyses that explored the implications of the uncertain key parameters showed that model outcomes were most sensitive to vaccine price per dose, discount rate, case-fatality rate of primary endpoint pneumonia, and vaccine efficacy against primary endpoint pneumonia. Based on the information available now, infant PCV vaccination would be expected to reduce pneumococcal diseases caused by S. pneumoniae in The Gambia. Assuming a cost-effectiveness threshold of three times GDP per capita, all PCVs examined would be cost-effective at the tentative Advance Market Commitment (AMC) price of $3.5 per dose. Because the cost-effectiveness of a PCV program could be affected by potential serotype replacement or herd immunity effects that may not be known until after a large scale introduction, type-specific surveillance and iterative evaluation will be critical.

The first study on therapeutic efficacies of a vascular disrupting agent CA4P among primary hepatocellular carcinomas with a full spectrum of differentiation and vascularity: Correlation of MRI-microangiography-histopathology in rats.

PubMed

Liu, Yewei; De Keyzer, Frederik; Wang, Yixing; Wang, Fengna; Feng, Yuanbo; Chen, Feng; Yu, Jie; Liu, Jianjun; Song, Shaoli; Swinnen, Johan; Bormans, Guy; Oyen, Raymond; Huang, Gang; Ni, Yicheng

2018-04-29

To better inform the next clinical trials of vascular disrupting agent Combretastatin-A4-phosphate (CA4P) in patients with hepatic malignancies, this preclinical study aimed at evaluating CA4P therapeutic efficacy in rats with primary hepatocellular carcinomas (HCCs) of a full spectrum of differentiation and vascularity by magnetic resonance imaging (MRI), microangiography and histopathology. Ninety-six HCCs were raised in 25 rats by diethylnitrosamine gavage. Tumor growth was monitored by T2-/T1-weighted-MRI (T2WI, T1WI) using a 3.0T scanner. Early vascular response and later intratumoral necrosis were detected by dynamic-contrast-enhanced (DCE) MRI and diffusion-weighted-imaging (DWI) before, 1h and 12h after CA4P iv-administration. In-vivo MRI-findings were validated by postmortem-techniques. Multi-parametric MRI revealed rapid CA4P-induced tumor vascular shutdown within 1h, followed by variable intratumoral necrosis at 12h. Tumor volumes decreased by 10% at 1h (P<0.05), but resumed at 12h. Correlations of semi-quantitative DCE parameter initial-area-under-the-gadolinium-curve (IAUGC30) with histopathology proved partial vascular closure and compensational reopening (P<0.05). The higher grades of vascularity prevented those residual tumor tissues from CA4P-caused ischemic necrosis. By histopathology using a 4-scale cellular-differentiation criteria and a 4-grade tumor-vascularity classification, percentage of CA4P-induced necrosis negatively correlated with HCC differentiation (r=-0.404, P<0.001) and tumor vascularity (r=-0.370, P<0.001). Ordinal-logistic-regression helped to predict early tumor responses to CA4P in terms of tumoral differentiation and vascularity. This study demonstrated that CA4P could induce vascular shutdown in primary HCCs within 1h, resulting in various degrees of tumor necrosis at 12h. MRI as a real-time imaging biomarker may help to define tumor vascularity and differentiation and further to predict CA4P therapeutic outcomes. This article is protected by copyright. All rights reserved. © 2018 UICC.

Effect of Primary Tumor Location on Second- or Later-line Treatment Outcomes in Patients With RAS Wild-type Metastatic Colorectal Cancer and All Treatment Lines in Patients With RAS Mutations in Four Randomized Panitumumab Studies.

PubMed

Boeckx, Nele; Koukakis, Reija; Op de Beeck, Ken; Rolfo, Christian; Van Camp, Guy; Siena, Salvatore; Tabernero, Josep; Douillard, Jean-Yves; André, Thierry; Peeters, Marc

2018-03-08

The primary tumor location has a prognostic impact in metastatic colorectal cancer (mCRC). We report the results from retrospective analyses assessing the effect of tumor location on prognosis and efficacy of second- and later-line panitumumab treatment in patients with RAS wild-type (WT) mCRC and on prognosis in all lines of treatment in patients with RAS mutant (MT) mCRC. RAS WT data (n = 483) from 2 randomized phase III panitumumab trials (ClinicalTrials.gov identifiers, NCT00339183 and NCT00113763) were analyzed for treatment outcomes stratified by tumor location. The second analysis assessed the effect of tumor location in RAS MT patients (n = 1205) from 4 panitumumab studies (ClinicalTrials.gov identifiers, NCT00364013, NCT00819780, NCT00339183, and NCT00113763). Primary tumors located in the cecum to transverse colon were coded as right-sided; those located from the splenic flexure to the rectum were coded as left-sided. Of all patients, the tumor location was ascertained for 83% to 88%; 71% to 77% of patients had left-sided tumors. RAS WT patients with right-sided tumors did worse for all efficacy parameters compared with those with left-sided tumors. The patients with left-sided tumors had better outcomes with panitumumab than with the comparator treatment. Because of the low patient numbers, no conclusions could be drawn for right-sided mCRC. The prognostic effect of tumor location on survival was unclear for RAS MT patients. These retrospective analyses have confirmed that RAS WT right-sided mCRC is associated with a poor prognosis, regardless of the treatment. RAS WT patients with left-sided tumors benefitted from the addition of panitumumab in second or later treatment lines. Further research is warranted to determine the optimum management of right-sided mCRC and RAS MT tumors. Copyright © 2018 Elsevier Inc. All rights reserved.

Probiotics as beneficial agents in the management of diabetes mellitus: a systematic review.

PubMed

Razmpoosh, Elham; Javadi, Maryam; Ejtahed, Hanieh-Sadat; Mirmiran, Parvin

2016-02-01

Probiotics have been suggested to play an important role in the management of diabetes. We conducted a systematic review on the role of probiotics in modulating parameters related to diabetes in animal and human experiments. We searched Pubmed, Scopus and Cochrane central until June 2014, concerning the effects of probiotics on hyperglycemia, hyperinsulinemia and their anti-diabetic efficacies by modulating the activities of proinflammatory and antioxidant factors. Our initial search retrieved 1120 reports. After screening titles and abstracts, 72 full-text articles were reviewed for eligibility. Ultimately, 33 articles met our inclusion criteria consisting of five human and twenty eight animal reports. Lactobacillus strains were, in particular, used in all studies with or without other strains. We found that probiotics have beneficial effects on glycemic controls, as all human studies showed significant reductions in at least one of the primary outcome endpoints which were the levels of fasting plasma glucose, postprandial blood glucose, glycated haemoglobin, insulin, insulin resistance and onset of diabetes; similarly, all the animal reports, except for two, documented significant changes in these parameters. Regarding secondary outcome measures, that is, lipid profiles, pro-inflammatory and anti-oxidant factors, only one human and one animal study failed to show any significant changes in any of these parameters. This systematic review generally demonstrated beneficial effects of the probiotic administration, especially Lactobacillus sub-strains, on the management of diabetes-related blood parameters, although, more evidence, especially from human trials, is needed to confirm these effects and also to conduct a meta-analysis. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

The efficacy of the modified Atkins diet in North Sea Progressive Myoclonus Epilepsy: an observational prospective open-label study.

PubMed

van Egmond, Martje E; Weijenberg, Amerins; van Rijn, Margreet E; Elting, Jan Willem J; Gelauff, Jeannette M; Zutt, Rodi; Sival, Deborah A; Lambrechts, Roald A; Tijssen, Marina A J; Brouwer, Oebele F; de Koning, Tom J

2017-03-07

North Sea Progressive Myoclonus Epilepsy is a rare and severe disorder caused by mutations in the GOSR2 gene. It is clinically characterized by progressive myoclonus, seizures, early-onset ataxia and areflexia. As in other progressive myoclonus epilepsies, the efficacy of antiepileptic drugs is disappointingly limited in North Sea Progressive Myoclonus Epilepsy. The ketogenic diet and the less restrictive modified Atkins diet have been proven to be effective in other drug-resistant epilepsy syndromes, including those with myoclonic seizures. Our aim was to evaluate the efficacy of the modified Atkins diet in patients with North Sea Progressive Myoclonus Epilepsy. Four North Sea Progressive Myoclonus Epilepsy patients (aged 7-20 years) participated in an observational, prospective, open-label study on the efficacy of the modified Atkins diet. Several clinical parameters were assessed at baseline and again after participants had been on the diet for 3 months. The primary outcome measure was health-related quality of life, with seizure frequency and blinded rated myoclonus severity as secondary outcome measures. Ketosis was achieved within 2 weeks and all patients completed the 3 months on the modified Atkins diet. The diet was well tolerated by all four patients. Health-related quality of life improved considerably in one patient and showed sustained improvement during long-term follow-up, despite the progressive nature of the disorder. Health-related quality of life remained broadly unchanged in the other three patients and they did not continue the diet. Seizure frequency remained stable and blinded rating of their myoclonus showed improvement, albeit modest, in all patients. This observational, prospective study shows that some North Sea Progressive Myoclonus Epilepsy patients may benefit from the modified Atkins diet with sustained health-related quality of life improvement. Not all our patients continued on the diet, but nonetheless we show that the modified Atkins diet might be considered as a possible treatment in this devastating disorder.

Efficacy and safety of flavocoxid compared with naproxen in subjects with osteoarthritis of the knee- a subset analysis.

PubMed

Levy, Robert; Khokhlov, Alexander; Kopenkin, Sergey; Bart, Boris; Ermolova, Tatiana; Kantemirova, Raiasa; Mazurov, Vadim; Bell, Marjorie; Caldron, Paul; Pillai, Lakshmi; Burnett, Bruce

2010-12-01

twice-daily flavocoxid, a cyclooxygenase and 5-lipoxygenase inhibitor with potent antioxidant activity of botanical origin, was evaluated for 12 weeks in a randomized, double-blind, active-comparator study against naproxen in 220 subjects with moderate-severe osteoarthritis (OA) of the knee. As previously reported, both groups noted a significant reduction in the signs and symptoms of OA with no detectable differences in efficacy between the groups when the entire intent-to-treat population was considered. This post-hoc analysis compares the efficacy of flavocoxid to naproxen in different subsets of patients, specifically those related to age, gender, and disease severity as reported at baseline for individual response parameters. in the original randomized, double-blind study, 220 subjects were assigned to receive either flavocoxid (500 mg twice daily) or naproxen (500 mg twice daily) for 12 weeks. In this subgroup analysis, primary outcome measures including the Western Ontario and McMaster Universities OA index and subscales, timed walk, and secondary efficacy variables, including investigator global assessment for disease and global response to treatment, subject visual analog scale for discomfort, overall disease activity, global response to treatment, index joint tenderness and mobility, were evaluated for differing trends between the study groups. subset analyses revealed some statistically significant differences and some notable trends in favor of the flavocoxid group. These trends became stronger the longer the subjects continued on therapy. These observations were specifically noted in older subjects (>60 years), males and in subjects with milder disease, particularly those with lower subject global assessment of disease activity and investigator global assessment for disease and faster walking times at baseline. initial analysis of the entire intent-to-treat population revealed that flavocoxid was as effective as naproxen in managing the signs and symptoms of OA of the knee. Detailed analyses of subject subsets demonstrated distinct trends in favor of flavocoxid for specific groups of subjects.

Evaluating the safety and efficacy of dextromethorphan/quinidine in the treatment of pseudobulbar affect

PubMed Central

Schoedel, Kerri A; Morrow, Sarah A; Sellers, Edward M

2014-01-01

Pseudobulbar affect (PBA) is a common manifestation of brain pathology associated with many neurological diseases, including amyotrophic lateral sclerosis, Alzheimer’s disease, stroke, multiple sclerosis, Parkinson’s disease, and traumatic brain injury. PBA is defined by involuntary and uncontrollable expressed emotion that is exaggerated and inappropriate, and also incongruent with the underlying emotional state. Dextromethorphan/quinidine (DM/Q) is a combination product indicated for the treatment of PBA. The quinidine component of DM/Q inhibits the cytochrome P450 2D6-mediated metabolic conversion of dextromethorphan to its active metabolite dextrorphan, thereby increasing dextromethorphan systemic bioavailability and driving the pharmacology toward that of the parent drug and away from adverse effects of the dextrorphan metabolite. Three published efficacy and safety studies support the use of DM/Q in the treatment of PBA; significant effects were seen on the primary end point, the Center for Neurologic Study-Lability Scale, as well as secondary efficacy end points and quality of life. While concentration–effect relationships appear relatively weak for efficacy parameters, concentrations of DM/Q may have an impact on safety. Some special safety concerns exist with DM/Q, primarily because of the drug interaction and QT prolongation potential of the quinidine component. However, because concentrations of dextrorphan (which is responsible for many of the parent drug’s side effects) and quinidine are lower than those observed in clinical practice with these drugs administered alone, some of the perceived safety issues may not be as relevant with this low dose combination product. However, since patients with PBA have a variety of other medical problems and are on numerous other medications, they may not tolerate DM/Q adverse effects, or may be at risk for drug interactions. Some caution is warranted when initiating DM/Q treatment, particularly in patients with underlying risk factors for torsade de pointes and in those receiving medications that may interact with DM/Q. PMID:25061302

Evaluating the safety and efficacy of dextromethorphan/quinidine in the treatment of pseudobulbar affect.

PubMed

Schoedel, Kerri A; Morrow, Sarah A; Sellers, Edward M

2014-01-01

Pseudobulbar affect (PBA) is a common manifestation of brain pathology associated with many neurological diseases, including amyotrophic lateral sclerosis, Alzheimer's disease, stroke, multiple sclerosis, Parkinson's disease, and traumatic brain injury. PBA is defined by involuntary and uncontrollable expressed emotion that is exaggerated and inappropriate, and also incongruent with the underlying emotional state. Dextromethorphan/quinidine (DM/Q) is a combination product indicated for the treatment of PBA. The quinidine component of DM/Q inhibits the cytochrome P450 2D6-mediated metabolic conversion of dextromethorphan to its active metabolite dextrorphan, thereby increasing dextromethorphan systemic bioavailability and driving the pharmacology toward that of the parent drug and away from adverse effects of the dextrorphan metabolite. Three published efficacy and safety studies support the use of DM/Q in the treatment of PBA; significant effects were seen on the primary end point, the Center for Neurologic Study-Lability Scale, as well as secondary efficacy end points and quality of life. While concentration-effect relationships appear relatively weak for efficacy parameters, concentrations of DM/Q may have an impact on safety. Some special safety concerns exist with DM/Q, primarily because of the drug interaction and QT prolongation potential of the quinidine component. However, because concentrations of dextrorphan (which is responsible for many of the parent drug's side effects) and quinidine are lower than those observed in clinical practice with these drugs administered alone, some of the perceived safety issues may not be as relevant with this low dose combination product. However, since patients with PBA have a variety of other medical problems and are on numerous other medications, they may not tolerate DM/Q adverse effects, or may be at risk for drug interactions. Some caution is warranted when initiating DM/Q treatment, particularly in patients with underlying risk factors for torsade de pointes and in those receiving medications that may interact with DM/Q.

Evidence for efficacy of acute treatment of episodic tension-type headache: methodological critique of randomised trials for oral treatments.

PubMed

Moore, R Andrew; Derry, Sheena; Wiffen, Philip J; Straube, Sebastian; Bendtsen, Lars

2014-11-01

The International Headache Society (IHS) provides guidance on the conduct of trials for acute treatment of episodic tension-type headache (TTH), a common disorder with considerable disability. Electronic and other searches identified randomised, double-blind trials of oral drugs treating episodic TTH with moderate or severe pain at baseline, or that tested drugs at first pain onset. The aims were to review methods, quality, and outcomes reported (in particular the IHS-recommended primary efficacy parameter pain-free after 2 hours), and to assess efficacy by meta-analysis. We identified 58 reports: 55 from previous reviews and searches, 2 unpublished reports, and 1 clinical trial report with results. We included 40 reports of 55 randomised trials involving 12,143 patients. Reporting quality was generally good, with potential risk of bias from incomplete outcome reporting and small size; the 23 largest trials involved 82% of patients. Few trials reported IHS outcomes. The number needed to treat values for being pain-free at 2 hours compared with placebo were 8.7 (95% confidence interval [CI] 6.2 to 15) for paracetamol 1000 mg, 8.9 (95% CI 5.9 to 18) for ibuprofen 400mg, and 9.8 (95% CI 5.1 to 146) for ketoprofen 25mg. Lower (better) number needed to treat values were calculated for outcomes of mild or no pain at 2 hours, and patient global assessment. These were similar to values for these drugs in migraine. No other drugs had evaluable results for these patient-centred outcomes. There was no evidence that any one outcome was better than others. The evidence available for treatment efficacy is small in comparison to the size of the clinical problem. Copyright © 2014 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

Efficacy of Botulinum toxin A for the treatment of Bladder pain syndrome: A systematic review.

PubMed

Ochoa Vargas, D C; García Perdómo, H A

2018-04-01

To determine the efficacy and safety of BTX-A, compared with other interventions for the treatment of BPS to improve quality of life. This systematic review fulfils all the requirements of the Cochrane manual and PRISMA reporting guidelines. The PROSPERO registration number is: CRD42016039480.Clinical trials without language discrimination were included. BPS patients over 18 y/o that were treated with BTX-A were included. Studies were searched in published databases and no published literature from inception to the present day. Risk of bias analysis was done using the Cochrane risk of bias tool. 88 articles were found with the designed search strategies. After exclusions, four studies were included in the qualitative analyses. Kasyan et al., 2012 compared BTX-A with hydrodistention. Manning et al., 2014 compared the injection of BTX-A with the injection of normal saline in previously hydrodistended bladders. In both cases, primary end point was measured by the O'Leary-Sant questionnaire score. El-Bahnasy et al., 2009 compared BTX-A with BCG administration, through Global Response Assessment. Kuo et al., 2015 compared hydrodistention plus suburothelial injections of BTX-A with hydrodistension plus normal saline injections. Reduction in pain was estimated by VAS bladder pain score. A similar efficacy to their controls had been found in Kasyan and Manning studies. El-Bahnasy had found improvement in BTX-A in all parameters. Kuo el al. 2015, found a significantly reduction in pain in the BTX-A group. Regarding the risk of bias, three studies did not have adequate descriptions of selection, performance and detection bias. The study of Manning had low risk of selection, attrition and reporting bias. There is not enough evidence to conclude the efficacy of BTX-A for the treatment of interstitial cystitis to improve quality of life. Copyright © 2017 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

Efficacy and Safety of Vilazodone in Patients With Generalized Anxiety Disorder: A Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Trial.

PubMed

Durgam, Suresh; Gommoll, Carl; Forero, Giovanna; Nunez, Rene; Tang, Xiongwen; Mathews, Maju; Sheehan, David V

2016-12-01

To evaluate the efficacy, safety, and tolerability of vilazodone as an acute treatment for generalized anxiety disorder (GAD). Vilazodone is a selective serotonin reuptake inhibitor and 5-HT1A receptor partial agonist approved for the treatment of major depressive disorder in adults. This was a randomized, placebo-controlled, parallel-group, multicenter, flexible-dose study conducted from May 2013-March 2014. Adult patients (18-70 years, inclusive) who met DSM-IV-TR criteria for GAD were randomized (1:1) to placebo or vilazodone 20-40 mg/d for 8 weeks of double-blind treatment. Primary and secondary efficacy parameters were change from baseline to week 8 in the Hamilton Anxiety Rating Scale (HARS) total score and in the Sheehan Disability Scale (SDS) total score, respectively, analyzed using a mixed-effects model for repeated measures approach on a modified intent-to-treat population. Safety outcomes were summarized descriptively. Efficacy analyses were based on 400 patients (placebo = 200, vilazodone = 200); 76% completed the study (placebo = 81%, vilazodone = 71%). The least squares mean difference (95% CI) in total score change from baseline to week 8 was statistically significant for vilazodone versus placebo on the HARS (-2.20 [-3.72 to -0.68]; P = .0048) and on the SDS (-1.89 [-3.52 to -0.26]; P = .0236). Treatment-emergent adverse events reported in ≥ 5% of vilazodone patients and at least twice the rate of placebo were nausea, diarrhea, dizziness, fatigue, delayed ejaculation, and erectile dysfunction. Statistically significant differences in favor of vilazodone 20-40 mg/d versus placebo were seen on all measures of anxiety and functional impairment in patients with GAD. Vilazodone was generally well tolerated, and no new safety concerns were noted. ClinicalTrials.gov identifier: NCT01844115. © Copyright 2016 Physicians Postgraduate Press, Inc.

Comparison of topical versus intravenous tranexamic acid in primary total knee arthroplasty: a meta-analysis of randomized controlled and prospective cohort trials.

PubMed

Wang, Hao; Shen, Bin; Zeng, Yi

2014-12-01

There has been much debate and controversy about the optimal regimen of tranexamic acid in primary total knee arthroplasty. The purpose of this study was to undertake a meta-analysis to compare the efficacy of topical and intravenous regimen of tranexamic acid in primary total knee arthroplasty. A systematic review of the electronic databases PubMed, CENTRAL, Web of Science, and Embase was undertaken. All randomized controlled trials and prospective cohort studies evaluating the effectiveness of topical and intravenous tranexamic acid during primary total knee arthroplasty were included. The focus of the analysis was on the outcomes of blood loss, transfusion rate, and thromboembolic complications. Subgroup analysis was performed when possible. Of 328 papers identified, six trials were eligible for data extraction and meta-analysis comprising 679 patients (739 knees). We found no statistically significant difference between topical and intravenous administration of tranexamic acid in terms of blood loss, transfusion requirements and thromboembolic complications. Topical tranexamic acid has a similar efficacy to intravenous tranexamic acid in reducing both blood loss and transfusion rate without sacrificing safety in primary total knee arthroplasty. II. Copyright © 2014 Elsevier B.V. All rights reserved.

Physician perceptions of primary prevention: qualitative base for the conceptual shaping of a practice intervention tool

PubMed Central

Mirand, Amy L; Beehler, Gregory P; Kuo, Christina L; Mahoney, Martin C

2002-01-01

Background A practice intervention must have its basis in an understanding of the physician and practice to secure its benefit and relevancy. We used a formative process to characterize primary care physician attitudes, needs, and practice obstacles regarding primary prevention. The characterization will provide the conceptual framework for the development of a practice tool to facilitate routine delivery of primary preventive care. Methods A focus group of primary care physician Opinion Leaders was audio-taped, transcribed, and qualitatively analyzed to identify emergent themes that described physicians' perceptions of prevention in daily practice. Results The conceptual worth of primary prevention, including behavioral counseling, was high, but its practice was significantly countered by the predominant clinical emphasis on and rewards for secondary care. In addition, lack of health behavior training, perceived low self-efficacy, and patient resistance to change were key deterrents to primary prevention delivery. Also, the preventive focus in primary care is not on cancer, but on predominant chronic nonmalignant conditions. Conclusions The success of the future practice tool will be largely dependent on its ability to "fit" primary prevention into the clinical culture of diagnoses and treatment sustained by physicians, patients, and payers. The tool's message output must be formatted to facilitate physician delivery of patient-tailored behavioral counseling in an accurate, confident, and efficacious manner. Also, the tool's health behavior messages should be behavior-specific, not disease-specific, to draw on shared risk behaviors of numerous diseases and increase the likelihood of perceived salience and utility of the tool in primary care. PMID:12204096

Bully/Victim Problems among Greek Pupils with Special Educational Needs: Associations with Loneliness and Self-Efficacy for Peer Interactions

ERIC Educational Resources Information Center

Andreou, Eleni; Didaskalou, Eleni; Vlachou, Anastasia

2015-01-01

This study explores the prevalence of different types of bullying and victimisation among Greek pupils receiving special education support provision. Associations of these types with feelings of loneliness and perceived social efficacy for peer interactions are also examined. The sample consisted of 178 students of fifth and sixth primary school…

A Study of the Relationship between Multicultural Teaching Training Methods and Teacher Attitudes about Diversity in Rural Schools

ERIC Educational Resources Information Center

Gray, Russell E.

2010-01-01

The lack of research about the efficacy of the three primary methods for training teachers to work with students from diverse cultures makes it difficult for universities to provide the proper training. The following quantitative, non-experimental, causal-comparative, ex-post facto study gathered and analyzed data concerning the efficacy of the…

Precursors of Teachers' Sense of Efficacy to Address the Literacy Learning of Diverse Students

ERIC Educational Resources Information Center

Stroder, Miriam Elizabeth

2017-01-01

The purpose of this qualitative case study was to explore through the lens of culturally responsive instruction (CRI) the development of teachers' sense of efficacy, as defined by Bandura (1995), to address the literacy learning of diverse first, second, or third grade (i.e., primary grade level) students. In this process, I purposively selected…

Paroxetine Treatment in Children and Adolescents with Major Depressive Disorder: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial

ERIC Educational Resources Information Center

Emslie, Graham J.; Wagner, Karen Dineen; Kutcher, Stan; Krulewicz, Stan; Fong, Regan; Carpenter, David J.; Lipschitz, Alan; Machin, Andrea; Wilkinson, Christel

2006-01-01

Objective: To assess the efficacy and tolerability of paroxetine in pediatric major depressive disorder. Method: Subjects 7 to 17 years old with major depressive disorder received paroxetine (10-50 mg/day) or placebo for 8 weeks from 2000 to 2001. The primary efficacy measure was change from baseline in the Children's Depression Rating…

Development and Application of an Instrument to Measure Greek Primary Education Teachers' Biology Teaching Self-Efficacy Beliefs

ERIC Educational Resources Information Center

Mavrikaki, Evangelia; Athanasiou, Kyriacos

2011-01-01

The self-efficacy beliefs of in-service elementary school teachers in Greece were examined in an attempt to evaluate their biology teaching skills. For this purpose, we constructed a valid and reliable instrument consisting of a Likert-type questionnaire that was distributed to the target population and to which 202 teachers responded. Results…

Influence of Difficulty with Language of Mathematics on Perceived Self-Efficacy in Learning Mathematics among Upper Primary Students of Kerala

ERIC Educational Resources Information Center

Sarabi, M. K.; Gafoor, K. Abdul

2017-01-01

There is increasing realization that mathematics-related self-efficacy expectations are a strong predictor of an array of significant mathematics outcomes. It is also evident that the curricular practice in schools largely neglects development of a student understanding in the unique language of mathematics. Consequently, this study probes how…

Effects of Two Different Anesthetic Solutions on Injection Pain, Efficacy, and Duration of Soft-Tissue Anesthesia with Inferior Alveolar Nerve Block for Primary Molars.

PubMed

Elbay, Ülkü Şermet; Elbay, Mesut; Kaya, Emine; Yıldırım, Sinem

The purpose of the study was to compare the efficacy, injection pain, duration of soft tissue anesthesia, and postoperative complications of two different anesthetics (2% lidocaine with 1:80,000 epinephrine and 3% plain mepivacaine) in pediatric patients in inferior alveolar nerve block (IANB) administered by a computer-controlled delivery system (CCDS). The study was conducted as a randomized, controlled-crossover, double-blind clinical trial with 60 children requiring bilateral pulpotomy or extraction of primary mandibular molars. A CCDS was used to deliver 3% mepivacaine to 1 primary tooth and 2% lidocaine to the contralateral tooth with an IANB technique. Severity of pain and efficacy of anesthesia were evaluated using the Face, Legs, Activity, Cry, Consolability Scale, and comfort and side effects were assessed using a questionnaire. Data were analyzed using the Mann-Whitney U, Wilcoxon t, and Fisher exact tests. Patients receiving 2% lidocaine experienced significantly less pain during injection than those receiving 3% mepivacaine, and no significant differences were found in the pain scores during treatments or in postoperative complications between the two anesthetics. The mean durations of anesthesia for 3% mepivacaine and 2% lidocaine were 139.68 minutes and 149.10 minutes, respectively. Plain mepivacaine and 2% lidocaine were similarly effective in pulpotomy and the extraction of primary mandibular molars. Although the use of 3% mepivacaine provided a shorter duration of anesthesia than 2% lidocaine, both solutions showed similar results in terms of postoperative complications.

Risk-benefit of dexrazoxane for preventing anthracycline-related cardiotoxicity: re-evaluating the European labeling.

PubMed

Reichardt, Peter; Tabone, Marie-Dominique; Mora, Jaume; Morland, Bruce; Jones, Robin L

2018-05-11

Dexrazoxane can prevent anthracycline-associated cardiotoxicity. However, in 2011, its use in children was contraindicated by the EMA over concerns of increased risk of infection, myelosuppression and second primary malignancies, and because its efficacy in children had not then been established. We review here the evidence published since 2011, which confirms that dexrazoxane is an effective cardioprotectant in children and adolescents, is not associated with an increased risk of second primary malignancies or excess early or late mortality and does not impair chemotherapy efficacy. Based on this evidence, the contraindication for children and adolescents requiring high doses of anthracyclines and at risk for cardiotoxicity was removed from the European labeling for dexrazoxane.

Bridges to Better Health and Wellness: An Adapted Health Care Manager Intervention for Hispanics with Serious Mental Illness.

PubMed

Cabassa, Leopoldo J; Manrique, Yamira; Meyreles, Quisqueya; Camacho, David; Capitelli, Lucia; Younge, Richard; Dragatsi, Dianna; Alvarez, Juana; Lewis-Fernández, Roberto

2018-01-01

This study examined the feasibility, acceptability, and initial impact of bridges to better health and wellness (B2BHW), a culturally-adapted health care manager intervention for Hispanics with serious mental illness (SMI). Thirty-four Hispanics with SMI and at risk for cardiovascular disease were enrolled. Mixed-linear models were used to examine changes over 12-months on patient activation, self-efficacy, patient-rated quality of care, receipt of preventive primary care services, and quality of life. The majority of participants completed the intervention (85%) with high satisfaction. Significant improvements were found for patient activation, self-efficacy, patients' ratings of quality of care, and receipt of preventive primary care.

Scientific Inquiry Self-Efficacy and Computer Game Self-Efficacy as Predictors and Outcomes of Middle School Boys' and Girls' Performance in a Science Assessment in a Virtual Environment

NASA Astrophysics Data System (ADS)

Bergey, Bradley W.; Ketelhut, Diane Jass; Liang, Senfeng; Natarajan, Uma; Karakus, Melissa

2015-10-01

The primary aim of the study was to examine whether performance on a science assessment in an immersive virtual environment was associated with changes in scientific inquiry self-efficacy. A secondary aim of the study was to examine whether performance on the science assessment was equitable for students with different levels of computer game self-efficacy, including whether gender differences were observed. We examined 407 middle school students' scientific inquiry self-efficacy and computer game self-efficacy before and after completing a computer game-like assessment about a science mystery. Results from path analyses indicated that prior scientific inquiry self-efficacy predicted achievement on end-of-module questions, which in turn predicted change in scientific inquiry self-efficacy. By contrast, computer game self-efficacy was neither predictive of nor predicted by performance on the science assessment. While boys had higher computer game self-efficacy compared to girls, multi-group analyses suggested only minor gender differences in how efficacy beliefs related to performance. Implications for assessments with virtual environments and future design and research are discussed.

Comparative efficacy and safety of antipsychotics in the treatment of schizophrenia: a network meta-analysis in a Japanese population.

PubMed

Kishi, Taro; Ikuta, Toshikazu; Matsunaga, Shinji; Matsuda, Yuki; Oya, Kazuto; Iwata, Nakao

2017-01-01

The relative efficacy and tolerability of antipsychotics for schizophrenia are considerably well studied. This study aimed to examine whether previous findings could be replicated in a genetically distinct and homogenous group (ie, Japanese patients with schizophrenia) and whether previous findings could be extended to a broader range of antipsychotics with previously unclear relative efficacy and tolerability. Bayesian network meta-analysis was performed in which randomized trials comparing any of the following interventions were included: second-generation antipsychotics, haloperidol, or placebo. The primary outcomes for efficacy and acceptability were the response rate and all-cause discontinuation. The secondary outcomes included the improvement of Positive and Negative Syndrome Scale scores, discontinuation because of adverse events, and individual adverse events. Eighteen relevant studies were identified (total n=3,446; aripiprazole =267, blonanserin =285, clozapine =47, clocapramine =295, haloperidol =857, mosapramine =493, olanzapine =179, paliperidone =136, perospirone =146, placebo =138, quetiapine =212, and risperidone =338; mean study duration =8.33±1.41 weeks). In primary outcomes, olanzapine and paliperidone showed efficacy than placebo, and olanzapine and paliperidone showed superior acceptability compared with placebo. There were differences in the incidences of individual adverse events (the best antipsychotic: extrapyramidal symptoms = olanzapine, hyperprolactinemia- related symptoms = quetiapine, sedation = paliperidone, and weight change = blonanserin) among antipsychotics. Although the current analysis exclusively included Japanese patients with schizophrenia, no remarkable differences were observed in efficacy and safety compared with previous meta-analyses. Diverse hierarchies in safety outcomes also support the implication that individual risk expectations for adverse events can guide clinical decisions. However, the sample size was relatively limited. Additional efficacy and safety data are required to fully obtain a conclusive understanding.

Comparative efficacy and safety of antipsychotics in the treatment of schizophrenia: a network meta-analysis in a Japanese population

PubMed Central

Kishi, Taro; Ikuta, Toshikazu; Matsunaga, Shinji; Matsuda, Yuki; Oya, Kazuto; Iwata, Nakao

2017-01-01

Background The relative efficacy and tolerability of antipsychotics for schizophrenia are considerably well studied. This study aimed to examine whether previous findings could be replicated in a genetically distinct and homogenous group (ie, Japanese patients with schizophrenia) and whether previous findings could be extended to a broader range of antipsychotics with previously unclear relative efficacy and tolerability. Methods Bayesian network meta-analysis was performed in which randomized trials comparing any of the following interventions were included: second-generation antipsychotics, haloperidol, or placebo. The primary outcomes for efficacy and acceptability were the response rate and all-cause discontinuation. The secondary outcomes included the improvement of Positive and Negative Syndrome Scale scores, discontinuation because of adverse events, and individual adverse events. Results Eighteen relevant studies were identified (total n=3,446; aripiprazole =267, blonanserin =285, clozapine =47, clocapramine =295, haloperidol =857, mosapramine =493, olanzapine =179, paliperidone =136, perospirone =146, placebo =138, quetiapine =212, and risperidone =338; mean study duration =8.33±1.41 weeks). In primary outcomes, olanzapine and paliperidone showed efficacy than placebo, and olanzapine and paliperidone showed superior acceptability compared with placebo. There were differences in the incidences of individual adverse events (the best antipsychotic: extrapyramidal symptoms = olanzapine, hyperprolactinemia- related symptoms = quetiapine, sedation = paliperidone, and weight change = blonanserin) among antipsychotics. Conclusion Although the current analysis exclusively included Japanese patients with schizophrenia, no remarkable differences were observed in efficacy and safety compared with previous meta-analyses. Diverse hierarchies in safety outcomes also support the implication that individual risk expectations for adverse events can guide clinical decisions. However, the sample size was relatively limited. Additional efficacy and safety data are required to fully obtain a conclusive understanding. PMID:28553116

A Controlled Pilot Trial of PainTracker Self-Manager, a Web-Based Platform Combined With Patient Coaching, to Support Patients' Self-Management of Chronic Pain.

PubMed

Sullivan, Mark; Langford, Dale J; Davies, Pamela Stitzlein; Tran, Christine; Vilardaga, Roger; Cheung, Gifford; Yoo, Daisy; McReynolds, Justin; Lober, William B; Tauben, David; Vowles, Kevin E

2018-03-29

The objective of this study was to develop and pilot test a chronic pain empowerment and self-management platform, derived from acceptance and commitment therapy, in a pain specialty setting. A controlled, sequential, nonrandomized study design was used to accommodate intervention development and to test the efficacy of the PainTracker Self-Manager (PTSM) intervention (Web-based educational modules and outcome tracking combined with tailored patient coaching sessions and provider guidance). Generalized estimating equations evaluated changes over time (baseline, 3 months, 6 months) in pain self-efficacy (primary outcome), chronic pain acceptance (activity engagement and pain willingness), perceived efficacy in patient-provider interactions, pain intensity and interference, and overall satisfaction with pain treatment (secondary outcomes) between intervention (n = 48) and usual care control groups (n = 51). The full study sample (N = 99) showed greater improvements over time (significant Group × Time interactions) in pain self-efficacy and satisfaction with pain treatment. Among study completers (n = 82), greater improvement in activity engagement as well as pain intensity and interference were also observed. These preliminary findings support the efficacy of the PTSM intervention in a pain specialty setting. Further research is needed to refine and expand the PTSM intervention and to test it in a randomized trial in primary care settings. We developed a Web-based patient empowerment platform that combined acceptance and commitment therapy-based educational modules and tailored coaching sessions with longitudinal tracking of treatments and patient-reported outcomes, named PTSM. Pilot controlled trial results provide preliminary support for its efficacy in improving pain self-efficacy, activity engagement, pain intensity and interference, and satisfaction with pain treatment. Copyright © 2018 The American Pain Society. Published by Elsevier Inc. All rights reserved.

Comparison of Cleaning Efficacy and Instrumentation Time in Primary Molars: Mtwo Rotary Instruments vs. Hand K-Files.

PubMed

Ramezanali, Fatemeh; Afkhami, Farzaneh; Soleimani, Ali; Kharrazifard, Mohammad Javad; Rafiee, Farshid

2015-01-01

Pulpectomy is the preferred treatment for restorable primary teeth with symptomatic irreversible pulpitis or periradicular lesion. Considering the rather new application of rotary files for pulpectomy of primary teeth, the aim of this study was to compare the cleaning efficacy and instrumentation time of hand K-files and Mtwo rotary system for preparation of human primary molars. This experimental study was conducted on 100 extracted primary maxillary and mandibular intact molars with no resorption. Access cavities were prepared and India ink was injected into the root canal on a vibrator using an insulin syringe. Canals were then divided into 5 groups (n=20): in group I, canals were instrumented using K-files up to #25 for mesial and buccal canals and #30 for palatal and distal canals. In group II, canals were prepared using Mtwo rotary files (15/0.05, 20/0.06 and 25/0.06 for mesial and buccal canals and 15/0.05, 20/0.06, 25/0.06 and finally 30/0.05 for distal and palatal canals). In group III, root canals were only irrigated with saline. Groups IV and V were the positive and negative control groups, respectively. The time required for cleaning and preparation of the canals for each of the specimens in groups I, II and III was recorded. The mean score of cleanliness of Mtwo was not significantly different from K-file group (P>0.05). However the mean instrumentation time in Mtwo group was significantly shorter (P<0.001). Although there were no differences regarding the cleaning efficacy of either system, Mtwo rotary files were far more time efficient.

Preliminary examination of the efficacy and safety of a standardized chamomile extract for chronic primary insomnia: A randomized placebo-controlled pilot study

PubMed Central

2011-01-01

Background Despite being the most commonly used herbal for sleep disorders, chamomile's (Matricaria recutita) efficacy and safety for treating chronic primary insomnia is unknown. We examined the preliminary efficacy and safety of chamomile for improving subjective sleep and daytime symptoms in patients with chronic insomnia. Methods We performed a randomized, double-blind, placebo-controlled pilot trial in 34 patients aged 18-65 years with DSM-IV primary insomnia for ≥ 6-months. Patients were randomized to 270 mg of chamomile twice daily or placebo for 28-days. The primary outcomes were sleep diary measures. Secondary outcomes included daytime symptoms, safety assessments, and effect size of these measures. Results There were no significant differences between groups in changes in sleep diary measures, including total sleep time (TST), sleep efficiency, sleep latency, wake after sleep onset (WASO), sleep quality, and number of awakenings. Chamomile did show modest advantage on daytime functioning, although these did not reach statistical significance. Effect sizes were generally small to moderate (Cohen's d ≤ 0.20 to < 0.60) with sleep latency, night time awakenings, and Fatigue Severity Scale (FSS), having moderate effect sizes in favor of chamomile. However, TST demonstrated a moderate effect size in favor of placebo. There were no differences in adverse events reported by the chamomile group compared to placebo. Conclusion Chamomile could provide modest benefits of daytime functioning and mixed benefits on sleep diary measures relative to placebo in adults with chronic primary insomnia. However, further studies in select insomnia patients would be needed to investigate these conclusions. Trial Registration ClinicalTrials.gov Identifier NCT01286324 PMID:21939549

Long-Term Nightly Treatment with Indiplon in Adults with Primary Insomnia: Results of a Double-Blind, Placebo-Controlled, 3-Month Study

PubMed Central

Scharf, Martin B.; Black, Jed; Hull, Steven; Landin, Rick; Farber, Robert

2007-01-01

Objectives: To evaluate the efficacy and safety of indiplon in primary insomnia. Design: Randomized, double-blind, placebo-controlled, 3-month study. Setting: Multi-center outpatient setting. Patients: N=702 (61% female; mean age 46 years) who met DSM-IV criteria for primary insomnia of at least 3 months' duration. Interventions: Indiplon 10 mg (n=236), indiplon 20 mg (n=233), or placebo (n=233). Measurements: Subjective assessment of each of the following: latency to sleep onset (sLSO), total sleep time (sTST), number of awakenings after sleep onset (sNAASO), wake time after sleep onset (sWASO), sleep quality, Insomnia Severity Index (ISI), and global improvement. Results: Treatment with indiplon resulted in significant improvement relative to placebo at all time points for the primary endpoint, sLSO. Mean sLSO at Month 1 for each treatment group was: 10 mg (34.0 ± 1.3 mins), 20 mg (33.0 ± 1.3 mins), and placebo (48.7 ± 1.9 mins; P <0.0001 for both comparisons); efficacy was sustained through Month 3. Both doses of indiplon resulted in significant improvement in sleep maintenance and duration endpoints, sTST and sWASO, as well as sleep quality, ISI, and global improvement at all assessment time points. Conclusions: In patients with chronic insomnia, long-term nightly treatment with 10 mg and 20 mg doses of indiplon resulted in significant and sustained efficacy in sleep onset, maintenance, and duration, and significant associated improvement in both daytime functioning and quality of life. Citation: Scharf MB; Black J; Hull S et al. Long-term nightly treatment with indiplon in adults with primary insomnia: Results of a double-blind, placebo-controlled, 3-month study. SLEEP 2007;30(6):743-752. PMID:17580596

Use of the Dual-Antiplatelet Therapy Score to Guide Treatment Duration After Percutaneous Coronary Intervention.

PubMed

Piccolo, Raffaele; Gargiulo, Giuseppe; Franzone, Anna; Santucci, Andrea; Ariotti, Sara; Baldo, Andrea; Tumscitz, Carlo; Moschovitis, Aris; Windecker, Stephan; Valgimigli, Marco

2017-07-04

The dual-antiplatelet therapy (DAPT) score was developed to identify patients more likely to derive harm (score <2) or benefit (score ≥2) from prolonged DAPT after percutaneous coronary intervention (PCI). To evaluate the safety and efficacy of DAPT duration according to DAPT score. Retrospective assessment of DAPT score-guided treatment duration in a randomized clinical trial. (ClinicalTrials.gov: NCT00611286). PCI patients. 1970 patients undergoing PCI. DAPT (aspirin and clopidogrel) for 24 versus 6 months. Primary efficacy outcomes were death, myocardial infarction, or cerebrovascular accident. The primary safety outcome was type 3 or 5 bleeding according to the Bleeding Academic Research Consortium definition. Outcomes were assessed between 6 and 24 months. 884 patients (44.9%) had a DAPT score of at least 2, and 1086 (55.1%) had a score less than 2. The reduction in the primary efficacy outcome with 24- versus 6-month DAPT was greater in patients with high scores (risk difference [RD] for score ≥2, -2.05 percentage points [95% CI, -5.04 to 0.95 percentage points]; RD for score <2, 2.91 percentage points [CI, -0.43 to 6.25 percentage points]; P = 0.030). However, the difference by score for the primary efficacy outcome varied by stent type; prolonged DAPT with high scores was effective only in patients receiving paclitaxel-eluting stents (RD, -7.55 percentage points [CI, -12.85 to -2.25 percentage points]). The increase in the primary safety outcome with 24- versus 6-month DAPT was greater in patients with low scores (RD for score ≥2, 0.20 percentage point [CI, -1.20 to 1.60 percentage points]; RD for score <2, 2.58 percentage points [CI, 0.71 to 4.46 percentage points]; P = 0.046). Retrospective calculation of the DAPT score. Prolonged DAPT resulted in harm in patients with low DAPT scores undergoing PCI but reduced risk for ischemic events in patients with high scores receiving paclitaxel-eluting stents. Whether prolonged DAPT benefits patients with high scores treated with contemporary drug-eluting stents requires further study. None.

Survey on treatments for primary headaches in 13 specialized juvenile Headache Centers: The first multicenter Italian study.

PubMed

Toldo, Irene; Rattin, Martina; Perissinotto, Egle; De Carlo, Debora; Bolzonella, Barbara; Nosadini, Margherita; Rossi, Livia Nicoletta; Vecchio, Angelo; Simonati, Alessandro; Carotenuto, Marco; Scalas, Cinzia; Sciruicchio, Vittorio; Raieli, Vincenzo; Mazzotta, Giovanni; Tozzi, Elisabetta; Valeriani, Massimiliano; Cianchetti, Carlo; Balottin, Umberto; Guidetti, Vincenzo; Sartori, Stefano; Battistella, Pier Antonio

2017-05-01

The purpose of this retrospective multicenter study was to evaluate the use and the self-perceived efficacy and tolerability of pharmacological and non-pharmacological treatments in children and adolescents with primary headaches. Study of a cohort of children and adolescents diagnosed with primary headache, consecutively referred to 13 juvenile Italian Headache Centers. An ad hoc questionnaire was used for clinical data collection. Among 706 patients with primary headaches included in the study, 637 cases with a single type of headache (migraine 76% - with and without aura in 10% and 67% respectively; tension-type headache 24%) were selected (mean age at clinical interview: 12 years). Acetaminophen and non-steroidal anti-inflammatory drugs (in particular ibuprofen) were commonly used to treat attacks, by 76% and 46% of cases respectively. Triptans were used overall by 6% of migraineurs and by 13% of adolescents with migraine, with better efficacy than acetaminophen and non-steroidal anti-inflammatory drugs. Preventive drugs were used by 19% of migraineurs and by 3% of subjects with tension-type headache. In migraineurs, flunarizine was the most frequently used drug (18%), followed by antiepileptic drugs (7%) and pizotifen (6%), while cyproheptadine, propanolol and amitriptyline were rarely used. Pizotifen showed the best perceived efficacy and tolerability. Melatonin and nutraceuticals were used by 10% and 32% of subjects, respectively, both for migraine and tension-type headache, with good results in terms of perceived efficacy and tolerability. Non-pharmacological preventive treatments (i.e. relaxation techniques, biofeedback, cognitive-behavioral therapy, acupuncture) were used only by 10% of cases (migraine 9%, tension-type headache 15%). Non-steroidal anti-inflammatory drugs, especially ibuprofen, should be preferred to acetaminophen for acute attacks of migraine or tension-type headache, because they were usually more effective and well tolerated. Triptans could be used more frequently as first or almost second choice for treating migraine attack in adolescents. Non-pharmacological preventive treatments are recommended by some pediatric guidelines as first-line interventions for primary headaches and their use should be implemented in clinical practice. Prospective multicenter studies based on larger series are warranted to better understand the best treatment strategies for young people with primary headaches. Copyright © 2016 European Paediatric Neurology Society. Published by Elsevier Ltd. All rights reserved.

Clinical efficacy of Trigonella foenum graecum (Fenugreek) and dry cupping therapy on intensity of pain in patients with primary dysmenorrhea.

PubMed

Inanmdar, Wajida; Sultana, Arshiya; Mubeen, Umraz; Rahman, Khaleequr

2016-05-25

To determine the effificacy and safety of fenugreek seed and dry cupping on intensity of pain in primary dysmenorrhea. Sixty patients with primary dysmenorrhea were enrolled in this prospective, open-labeled, randomized, standard-controlled study, conducted in the National Institute of Unani Medicine Hospital between February 2010 and April 2011. In group A (20 cases), 3 g powder of fenugreek seed (3 capsules, 1 g each) was given orally twice daily from day 1 to 3 of menstrual cycle. Group B (20 cases) received the same dose of fenugreek seed as group A along with dry cupping therapy [two 4.2-cm and one 2.5-cm cups (internal diameter)], which was applied below the umbilicus for 15 min on day 1 and day 3 of menstrual cycle for 3 consecutive months. The control group C (20 cases) was given mefenamic acid, 500 mg twice daily, on the same protocol. The reduction in menstrual pain intensity was measured with well validated Visual Analogue Scale and safety of fenugreek seed was evaluated by clinical examination and laboratory investigations. Baseline characteristics and biochemical parameters were comparable and homogenous among all groups (P>0.05). The percentage reduction in lower abdominal pain was 66.89%, 66.49%, and 62.88% in A, B and C groups respectively at the end of the treatment. No adverse drug effects were noticed. The fenugreek seed and dry cupping are effificacious, safe, cost effective, and well tolerated.

Population pharmacokinetics and exposure-response of osimertinib in patients with non-small cell lung cancer.

PubMed

Brown, Kathryn; Comisar, Craig; Witjes, Han; Maringwa, John; de Greef, Rik; Vishwanathan, Karthick; Cantarini, Mireille; Cox, Eugène

2017-06-01

To develop a population (pop) pharmacokinetic (PK) model for osimertinib (AZD9291) and its metabolite (AZ5104) and investigate the exposure-response relationships for selected efficacy and safety parameters. PK, safety and efficacy data were collected from two non-small cell lung cancer (NSCLC) patient studies (n = 748) and one healthy volunteer study (n = 32), after single or multiple once-daily dosing of 20-240 mg osimertinib. Nonlinear mixed effects modelling was used to characterise the popPK. Individual exposure values were used to investigate the relationship with response evaluation criteria in solid tumours (RECIST 1.1) efficacy parameters and key safety parameters (rash, diarrhoea, QTcF). A popPK model that adequately described osimertinib and its metabolite AZ5104 in a joint manner was developed. Body weight, serum albumin and ethnicity were identified as significant covariates on PK in the analysis, but were not found to have a clinically relevant impact on osimertinib exposure. No relationship was identified between exposure and efficacy over the dose range studied. A linear relationship was observed between exposure and the occurrence of rash or diarrhoea, and between concentration and QTcF, with a predicted mean (upper 90% confidence interval) increase of 14.2 (15.8) ms at the maximum concentration for an 80 mg once-daily dose at steady state. PopPK and exposure-response models were developed for osimertinib and AZ5104. There was no relationship between exposure and efficacy but a linear relationship between exposure and safety endpoints (rash, diarrhoea and QTcF) was observed. © 2016 The British Pharmacological Society.

A three-parameter two-state model of receptor function that incorporates affinity, efficacy, and signal amplification.

PubMed

Buchwald, Peter

2017-06-01

A generalized model of receptor function is proposed that relies on the essential assumptions of the minimal two-state receptor theory (i.e., ligand binding followed by receptor activation), but uses a different parametrization and allows nonlinear response (transduction) for possible signal amplification. For the most general case, three parameters are used: K d , the classic equilibrium dissociation constant to characterize binding affinity; ε , an intrinsic efficacy to characterize the ability of the bound ligand to activate the receptor (ranging from 0 for an antagonist to 1 for a full agonist); and γ , a gain (amplification) parameter to characterize the nonlinearity of postactivation signal transduction (ranging from 1 for no amplification to infinity). The obtained equation, E/Emax=εγLεγ+1-εL+Kd, resembles that of the operational (Black and Leff) or minimal two-state (del Castillo-Katz) models, E/Emax=τLτ+1L+Kd, with εγ playing a role somewhat similar to that of the τ efficacy parameter of those models, but has several advantages. Its parameters are more intuitive as they are conceptually clearly related to the different steps of binding, activation, and signal transduction (amplification), and they are also better suited for optimization by nonlinear regression. It allows fitting of complex data where receptor binding and response are measured separately and the fractional occupancy and response are mismatched. Unlike the previous models, it is a true generalized model as simplified forms can be reproduced with special cases of its parameters. Such simplified forms can be used on their own to characterize partial agonism, competing partial and full agonists, or signal amplification.

Active Classroom Participation in a Group Scribbles Primary Science Classroom

ERIC Educational Resources Information Center

Chen, Wenli; Looi, Chee-Kit

2011-01-01

A key stimulus of learning efficacy for students in the classroom is active participation and engagement in the learning process. This study examines the nature of teacher-student and student-student discourse when leveraged by an interactive technology--Group Scribbles (GS) in a Primary 5 Science classroom in Singapore which supports rapid…

Project-Based Learning in Primary Schools: Effects on Pupils' Learning and Attitudes

ERIC Educational Resources Information Center

Kaldi, Stavroula; Filippatou, Diamanto; Govaris, Christos

2011-01-01

This study focuses upon the effectiveness of project-based learning on primary school pupils regarding their content knowledge and attitudes towards self-efficacy, task value, group work, teaching methods applied and peers from diverse ethnic backgrounds. A cross-curricular project was implemented within the curriculum area of environmental…

Motivation for Reading and Upper Primary School Students' Academic Achievement in Reading in Kenya

ERIC Educational Resources Information Center

Mucherah, Winnie; Herendeen, Abbey

2013-01-01

This study examined primary school students' reading motivation and performance on the standardized exam. Participants included 901 seventh and eighth grade students from Kenya. There were 468 females and 433 males. Contrary to previous studies, results showed reading challenge and aesthetics, but not efficacy, predicted reading achievement,…

Teachers' Knowledge and Confidence for Promoting Positive Mental Health in Primary School Communities

ERIC Educational Resources Information Center

Askell-Williams, Helen; Lawson, Michael J.

2013-01-01

This paper reports an investigation into Australian primary school teachers' knowledge and confidence for mental health promotion. Questionnaires were delivered to 1397 teachers. In-depth interviews were held with 37 teachers. Quantitative results showed that half to two thirds of teachers felt efficacious and knowledgeable about selected…

Electronic Portfolios in Grades One, Two and Three: A Cautionary Tale

ERIC Educational Resources Information Center

Kotsopoulos, Donna; Lee, Joanne; Cordy, Michelle; Bruyns, Susan

2015-01-01

Some electronic portfolios (EPs) developers are proposing that EPs are suitable for implementation in primary education (i.e. kindergarten to grade three). Yet, empirical research evaluating the implementation and efficacy of EPs used in primary school settings at both the teacher and the student level is scarce. In this research, the authors…

Using Quality Experts from Manufacturing to Transform Primary Care

ERIC Educational Resources Information Center

Steiner, Rose M.; Walsworth, David T.

2010-01-01

Introduction: Improving Performance in Practice (IPIP) is an initiative convened by the American Board of Medical Specialties. It investigates the efficacy of coaches in helping primary-care practices improve the care of patients with diabetes and asthma. Most IPIP states use coaches who have a health care background, and are trained in quality…

Comparison of the pattern, efficacy, and tolerability of self-medicated drugs in primary dysmenorrhea: a questionnaire based survey.

PubMed

Sugumar, Ramya; Krishnaiah, Vasundara; Channaveera, Gokul Shetty; Mruthyunjaya, Shilpa

2013-01-01

To compare the pattern, efficacy, and tolerability of self-medicated drugs and to assess the adequacy of their dose in primary dysmenorrhea (PD). A survey using a self-developed, validated, objective, and structured questionnaire as a tool was conducted among subjects with PD. Statistical analysis was carried out using Chi-square test and ANOVA with post-hoc Tuckey's test. Out of 641 respondents, 42% were self-medicated. The pattern of drugs used was: Dicyclomine, an unknown drug, mefenamic acid, mefenamic acid + dicyclomine, and metamizole by 35%, 29%, 26%, 9%, and 1% of respondents, respectively. Mefenamic acid + dicyclomine, the combination was the most efficacious in comparison to other drugs in moderate to severe dysmenorrhea. There was better tolerability with mefenamic acid + dicyclomine group compared to other drugs. Sub-therapeutic doses were used by 86% of self-medicating respondents. The prevailing self-medication practices were inappropriate in a substantial proportion of women with inadequate knowledge regarding appropriate drug choice, therapeutic doses, and their associated side effects.

Comparison of the immediate efficacy of the Spinomed® back orthosis and posture training support on walking ability in elderly people with thoracic kyphosis.

PubMed

Namdar, Nategh; Arazpour, Mokhtar; Ahmadi Bani, Monireh

2017-12-21

The effect of spinal orthoses, including the Spinomed ® and posture training support (PTS) in improving balance and reducing falls in older people has been previously evaluated. However, there is little evidence available regarding their effect on the walking ability of older individuals with thoracic hyperkyphosis. This study was therefore designed to compare the immediate effect of the Spinomed ® orthosis and PTS on specific gait parameters in this patient group. A total of 34 older volunteer subjects with thoracic hyperkyphosis participated in this study and were randomly allocated into two groups, to either walk with the Spinomed ® orthosis in situ or the PTS. The elderly mobility scale test (EMS), two-minute walk test (2-MWT), and 10-meter walk test (10-MWT) were used to evaluate their walking performance, the distance walked and their walking speed respectively. There were no significant differences in the mean age, body mass index (BMI), kyphosis angle, EMS, 2-MWT, and 10-MWT between the groups at baseline. All parameters were uniform amongst the two groups. The Spinomed ® orthosis and PTS both had a positive and significant effect on the EMS score, the 2-MWT, and the 10-MWT. No significant difference was detected between two the types of orthoses in terms of the EMS score, the 2-MWT, or the 10-MWT. The Spinomed ® and PTS were both effective in improving all the primary outcome measures, with similar improvements demonstrated by both orthoses. Implications for rehabilitations In this category, one of the approaches to treat the elderly with hyperkyphosis is the use of spinal orthoses such as Spinomed ® orthosis and posture training support (PTS). The results showed that the anti-kyphosis orthosis including Spinomed ® and PTS played effective roles in the elderly with hyperkyphosis to improve their walking function. According to the current study results, there was no significant difference between the efficacies of these orthoses in the mentioned parameters.

Systematic chemical and molecular profiling of MLL-rearranged infant acute lymphoblastic leukemia reveals efficacy of romidepsin

PubMed Central

Cruickshank, M N; Ford, J; Cheung, L C; Heng, J; Singh, S; Wells, J; Failes, T W; Arndt, G M; Smithers, N; Prinjha, R K; Anderson, D; Carter, K W; Gout, A M; Lassmann, T; O'Reilly, J; Cole, C H; Kotecha, R S; Kees, U R

2017-01-01

To address the poor prognosis of mixed lineage leukemia (MLL)-rearranged infant acute lymphoblastic leukemia (iALL), we generated a panel of cell lines from primary patient samples and investigated cytotoxic responses to contemporary and novel Food and Drug Administration-approved chemotherapeutics. To characterize representation of primary disease within cell lines, molecular features were compared using RNA-sequencing and cytogenetics. High-throughput screening revealed variable efficacy of currently used drugs, however identified consistent efficacy of three novel drug classes: proteasome inhibitors, histone deacetylase inhibitors and cyclin-dependent kinase inhibitors. Gene expression of drug targets was highly reproducible comparing iALL cell lines to matched primary specimens. Histone deacetylase inhibitors, including romidepsin (ROM), enhanced the activity of a key component of iALL therapy, cytarabine (ARAC) in vitro and combined administration of ROM and ARAC to xenografted mice further reduced leukemia burden. Molecular studies showed that ROM reduces expression of cytidine deaminase, an enzyme involved in ARAC deactivation, and enhances the DNA damage–response to ARAC. In conclusion, we present a valuable resource for drug discovery, including the first systematic analysis of transcriptome reproducibility in vitro, and have identified ROM as a promising therapeutic for MLL-rearranged iALL. PMID:27443263

Perceived benefits and barriers and self-efficacy affecting the attendance of health education programs among uninsured primary care patients.

PubMed

Kamimura, Akiko; Nourian, Maziar M; Jess, Allison; Chernenko, Alla; Assasnik, Nushean; Ashby, Jeanie

2016-12-01

Lifestyle interventions have shown to be effective in improving health status, health behaviors, and self-efficacy. However, recruiting participants to health education programs and ensuring the continuity of health education for underserved populations is often challenging. The goals of this study are: to describe the attendance of health education programs; to identify stages of change to a healthy lifestyle; to determine cues to action; and to specify factors affecting perceived benefits and barriers to healthy food choices and physical activity among uninsured primary care patients. Uninsured primary care patients utilizing a free clinic (N=621) completed a self-administered survey from September to December of 2015. US born English speakers, non-US born English speakers, and Spanish speakers reported different kinds of cues to action in attending health education programs. While self-efficacy increases perceived benefits and decreases perceived barriers for physical activity, it increases both perceived benefits and perceived barriers for healthy food choices. The participants who had attended health education programs did not believe that there were benefits for healthy food choices and physical activity. This study adds to the body of literature on health education for underserved populations. Copyright © 2016 Elsevier Ltd. All rights reserved.

Root Canal Cleaning Efficacy of Rotary and Hand Files Instrumentation in Primary Molars

PubMed Central

Nazari Moghaddam, Kiumars; Mehran, Majid; Farajian Zadeh, Hamideh

2009-01-01

INTRODUCTION: Pulpectomy of primary teeth is commonly carried out with hand files and broaches; a tricky and time consuming procedure. The purpose of this in vitro study was to compare the cleaning efficacy and time taken for instrumentation of deciduous molars using hand K-files and Flex Master rotary system. MATERIALS AND METHODS: In this study, 68 canals of 23 extracted primary molars with at least two third intact roots and 7-12 mm length were selected. After preparing an access cavity, K-file size #15 was introduced into the root canal and India ink was injected with an insulin syringe. Sixty samples were randomly divided in to experimental groups in group I (n=30), root canals were prepared with hand K-files; in group II (n=30), rotary Flex Master files were used for instrumentation, and in group III 8 remained samples were considered as negative controls. After clearing and root sectioning, the removal of India ink from cervical, middle, and apical thirds was scored. Data was analyzed using student's T-test and Mann-Whitney U test. RESULTS: There was no significant difference between experimental groups cleaning efficacy at the cervical, middle and apical root canal thirds. Only the coronal third scored higher in the hand instrumented group (P<0.001). Instrumentation with Flex Master rotary files was significantly less time consuming (P<0.001). CONCLUSION: Although there was no difference in cleanliness efficacy at the apical and middle thirds, the coronal third was more effectively cleaned with hand files. Predictably, time efficiency was a significant advantage with rotary technique. PMID:23940486

Development of an Aotus nancymaae Model for Shigella Vaccine Immunogenicity and Efficacy Studies

PubMed Central

Gregory, Michael; Lugo-Roman, Luis A.; Galvez Carrillo, Hugo; Tilley, Drake Hamilton; Baldeviano, Christian; Simons, Mark P.; Reynolds, Nathanael D.; Ranallo, Ryan T.; Suvarnapunya, Akamol E.; Venkatesan, Malabi M.; Oaks, Edwin V.

2014-01-01

Several animal models exist to evaluate the immunogenicity and protective efficacy of candidate Shigella vaccines. The two most widely used nonprimate models for vaccine development include a murine pulmonary challenge model and a guinea pig keratoconjunctivitis model. Nonhuman primate models exhibit clinical features and gross and microscopic colonic lesions that mimic those induced in human shigellosis. Challenge models for enterotoxigenic Escherichia coli (ETEC) and Campylobacter spp. have been successfully developed with Aotus nancymaae, and the addition of a Shigella-Aotus challenge model would facilitate the testing of combination vaccines. A series of experiments were designed to identify the dose of Shigella flexneri 2a strain 2457T that induces an attack rate of 75% in the Aotus monkey. After primary challenge, the dose required to induce an attack rate of 75% was calculated to be 1 × 1011 CFU. Shigella-specific immune responses were low after primary challenge and subsequently boosted upon rechallenge. However, preexisting immunity derived from the primary challenge was insufficient to protect against the homologous Shigella serotype. A successive study in A. nancymaae evaluated the ability of multiple oral immunizations with live-attenuated Shigella vaccine strain SC602 to protect against challenge. After three oral immunizations, animals were challenged with S. flexneri 2a 2457T. A 70% attack rate was demonstrated in control animals, whereas animals immunized with vaccine strain SC602 were protected from challenge (efficacy of 80%; P = 0.05). The overall study results indicate that the Shigella-Aotus nancymaae challenge model may be a valuable tool for evaluating vaccine efficacy and investigating immune correlates of protection. PMID:24595138

Obesity and hormonal contraceptive efficacy.

PubMed

Robinson, Jennifer A; Burke, Anne E

2013-09-01

Obesity is a major public health concern affecting an increasing proportion of reproductive-aged women. Avoiding unintended pregnancy is of major importance, given the increased risks associated with pregnancy, but obesity may affect the efficacy of hormonal contraceptives by altering how these drugs are absorbed, distributed, metabolized or eliminated. Limited data suggest that long-acting, reversible contraceptives maintain excellent efficacy in obese women. Some studies demonstrating altered pharmacokinetic parameters and increased failure rates with combined oral contraceptives, the contraceptive patch and emergency contraceptive pills suggest decreased efficacy of these methods. It is unclear whether bariatric surgery affects hormonal contraceptive efficacy. Obese women should be offered the full range of contraceptive options, with counseling that balances the risks and benefits of each method, including the risk of unintended pregnancy.

Improving Universal Suicide Prevention Screening in Primary Care by Reducing False Negatives

DTIC Science & Technology

2016-09-01

AWARD NUMBER: W81XWH-14-1-0272 TITLE: Improving universal suicide prevention screening in primary care by reducing false negatives PRINCIPAL...COVERED 9/1/2015-8/31/2016 4. TITLE AND SUBTITLE Improving universal suicide prevention screening in primary care by 5a. CONTRACT NUMBER reducing...proposed project is to develop a shortened version of the Suicide Cognitions Scale (SCS) and to evaluate its efficacy as a universal suicide prevention

Fluoride availability in human saliva after dentifrice use: correlation with anticaries effects in rats.

PubMed

Afflitto, J; Schmid, R; Esposito, A; Toddywala, R; Gaffar, A

1992-04-01

Studies were conducted to determine fluoride availability in saliva after dentifrice use and to relate this parameter to cariostatic efficacy in rat caries experiments. Three dentifrices--two commercial formulations (Colgate Winterfresh Gel and Crest Dentifrice with Na-Sr-polyacrylate) and an Experimental dentifrice--were compared with respect to salivary fluoride availability. All of the dentifrices tested contained 1100 ppm F as sodium fluoride. It was observed that the Experimental dentifrice and Crest dentifrice with Sr-polyacrylate exhibited low salivary fluoride availability relative to the Colgate Winterfresh Gel. Salivary fluoride availability was assessed by means of two parameters: (a) the fluoride concentration in the dentifrice saliva slurry expectorated after brushing, and (b) the area under the curve of salivary F concentration vs. time for up to two hours after dentifrice use. In two rat caries experiments, it was observed that both the Experimental dentifrice and the Sr-polyacrylate dentifrice provided less cariostatic efficacy than the clinically validated Positive Control (Colgate Winterfesh Gel). Analysis of these data provides further evidence in support of the concept that fluoride availability in saliva following dentifrice use is an important parameter related to anticaries efficacy.

Randomized, double-blind, placebo-controlled 8-week trial of the efficacy, safety, and tolerability of 5, 10, and 20 mg/day vortioxetine in adults with major depressive disorder.

PubMed

Nishimura, Akira; Aritomi, Yutaka; Sasai, Kiyofumi; Kitagawa, Tadayuki; Mahableshwarkar, Atul R

2018-02-01

This study assessed the efficacy and safety of vortioxetine in adults with major depressive disorder. In this double-blind, placebo-controlled study, 600 patients with major depressive disorder were randomly assigned (1:1:1:1) to receive vortioxetine 5, 10, or 20 mg, or placebo once daily for 8 weeks. The primary end-point was change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at week 8, evaluated by the last-observation-carried-forward method. Secondary end-points included response (≥ 50% decrease in the MADRS total score from baseline) and remission (MADRS total score ≤ 10), Clinical Global Impression Scale-Improvement, and change from baseline in Sheehan Disability Scale. Adverse events were summarized. Vortioxetine failed to show significant differences from placebo in the primary end-point. Nominally significant improvements over placebo were observed for vortioxetine doses of 10 and 20 mg when the primary end-point was evaluated using the mixed model for repeated measures as the secondary analysis, and 10 mg in secondary measures of response and patient functioning. Vortioxetine was well tolerated. Nausea, constipation, dry mouth, dizziness, and insomnia each occurred at a >twofold higher rate than placebo. Discontinuation symptom scores were comparable between all groups after 1 and 2 weeks following withdrawal of the study drug. While vortioxetine failed to meet significance versus placebo in the primary efficacy analysis, there was evidence of efficacy for the 10- and 20-mg doses in secondary analyses. Vortioxetine was safe and well tolerated. Additional studies appear warranted. © 2017 The Authors. Psychiatry and Clinical Neurosciences published by John Wiley & Sons Australia, Ltd on behalf of Japanese Society of Psychiatry and Neurology.

The Role of Self-control and Grit in Domains of School Success in Students of Primary and Secondary School

PubMed Central

Oriol, Xavier; Miranda, Rafael; Oyanedel, Juan C.; Torres, Javier

2017-01-01

Objective: Self-control and grit have become two of the most important variables that explain success in different aspects of people's daily life (Duckworth and Gross, 2014). Self-control promotes delayed gratification and directly influences thoughts, emotions, and impulses. On the other hand, grit enhances the achievement of goals through perseverance even before extreme external circumstances. Since both constructs are related, examining them together is compelling, as long as the different nuances that characterize each are taken into account. Two structural equation models (SEM) were conducted to observe the effect of self-control and grit on a more specific indicator of academic success (academic self-efficacy) and a more general indicator of school experience (satisfaction with school). Methods: The first model comprises 5,681 primary students (M = 9.05; SD = 0.79), and the second 10,017 secondary students (M = 14.20; SD = 1.04) from Lima, Peru. In both models, the influence of grit and self-control on school satisfaction was observed when taking self-efficacy as a mediator variable. Results: The results show that grit and self-control have strong associations in both primary and secondary students. When estimating the covariance of both constructs, grit is related with academic-self efficacy at both educational stages, but only to satisfaction with school in secondary students. On the contrary, self-control shows a significant relationship with school satisfaction only in primary education. In turn, self-efficacy shows a mediating effect between grit and school satisfaction. After calculating the invariance of the models, differences are observed by gender in the relationships between variables. Conclusion: The results indicate that both constructs are strongly interrelated. Regarding the associations with the indicators of academic success, a need for timely interventions specific to each educational stage is observed. PMID:29075211

The Role of Self-control and Grit in Domains of School Success in Students of Primary and Secondary School.

PubMed

Oriol, Xavier; Miranda, Rafael; Oyanedel, Juan C; Torres, Javier

2017-01-01

Objective: Self-control and grit have become two of the most important variables that explain success in different aspects of people's daily life (Duckworth and Gross, 2014). Self-control promotes delayed gratification and directly influences thoughts, emotions, and impulses. On the other hand, grit enhances the achievement of goals through perseverance even before extreme external circumstances. Since both constructs are related, examining them together is compelling, as long as the different nuances that characterize each are taken into account. Two structural equation models (SEM) were conducted to observe the effect of self-control and grit on a more specific indicator of academic success (academic self-efficacy) and a more general indicator of school experience (satisfaction with school). Methods: The first model comprises 5,681 primary students ( M = 9.05; SD = 0.79), and the second 10,017 secondary students ( M = 14.20; SD = 1.04) from Lima, Peru. In both models, the influence of grit and self-control on school satisfaction was observed when taking self-efficacy as a mediator variable. Results: The results show that grit and self-control have strong associations in both primary and secondary students. When estimating the covariance of both constructs, grit is related with academic-self efficacy at both educational stages, but only to satisfaction with school in secondary students. On the contrary, self-control shows a significant relationship with school satisfaction only in primary education. In turn, self-efficacy shows a mediating effect between grit and school satisfaction. After calculating the invariance of the models, differences are observed by gender in the relationships between variables. Conclusion: The results indicate that both constructs are strongly interrelated. Regarding the associations with the indicators of academic success, a need for timely interventions specific to each educational stage is observed.

Efficacy of Different Types of Mobilization Techniques in Patients With Primary Adhesive Capsulitis of the Shoulder: A Systematic Review.

PubMed

Noten, Suzie; Meeus, Mira; Stassijns, Gaetane; Van Glabbeek, Francis; Verborgt, Olivier; Struyf, Filip

2016-05-01

To systematically review the literature for efficacy of isolated articular mobilization techniques in patients with primary adhesive capsulitis (AC) of the shoulder. PubMed and Web of Science were searched for relevant studies published before November 2014. Additional references were identified by manual screening of the reference lists. All English language randomized controlled trials evaluating the efficacy of mobilization techniques on range of motion (ROM) and pain in adult patients with primary AC of the shoulder were included in this systematic review. Twelve randomized controlled trials involving 810 patients were included. Two reviewers independently screened the articles, scored methodologic quality, and extracted data for analysis. The review was conducted and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. All studies were assessed in duplicate for risk of bias using the Physiotherapy Evidence Database Scale for randomized controlled trials. The efficacy of 7 different types of mobilization techniques was evaluated. Angular mobilization (n=2), Cyriax approach (n=1), and Maitland technique (n=6) showed improvement in pain score and ROM. With respect to translational mobilizations (n=1), posterior glides are preferred to restore external rotation. Spine mobilizations combined with glenohumeral stretching and both angular and translational mobilization (n=1) had a superior effect on active ROM compared with sham ultrasound. High-intensity mobilization (n=1) showed less improvement in the Constant Murley Score than a neglect group. Finally, positive long-term effects of the Mulligan technique (n=1) were found on both pain and ROM. Overall, mobilization techniques have beneficial effects in patients with primary AC of the shoulder. Because of preliminary evidence for many mobilization techniques, the Maitland technique and combined mobilizations seem recommended at the moment. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Efficacy and Safety of Lubiprostone in Patients with Opioid-Induced Constipation: Phase 3 Study Results and Pooled Analysis of the Effect of Concomitant Methadone Use on Clinical Outcomes.

PubMed

Spierings, Egilius L H; Drossman, Douglas A; Cryer, Byron; Mazen Jamal, M; Losch-Beridon, Taryn; Mareya, Shadreck M; Wang, Martin

2018-06-01

The efficacy and safety of oral lubiprostone for relieving symptoms of opioid-induced constipation (OIC) in patients with chronic noncancer pain were evaluated in a randomized, double-blind, placebo-controlled study. These data were also pooled with those from two similar phase 3 studies to explore the effects of methadone on treatment response. In the primary study, adults with OIC (fewer than three spontaneous bowel movements [SBMs] per week) were randomized to receive lubiprostone 24 mcg or placebo twice daily for 12 weeks. The primary end point was a change from baseline in the frequency of SBMs at week 8 in patients without a prior dose reduction. For the pooled analysis, the efficacy of lubiprostone was compared with placebo in patients receiving methadone or nonmethadone opioids. Responders were defined as patients with nine or more weeks of nonmissing SBM data who had one or more additional SBMs per week from baseline for each week that data were available and three or more SBMs per week for nine or more weeks. In the primary study, the change from baseline at week 8 in SBM frequency was similar in the lubiprostone and placebo groups (P = 0.842). In the pooled analysis, the response rate was significantly higher with lubiprostone treatment vs placebo for patients receiving nonmethadone opioids (P = 0.002) but was similar between lubiprostone treatment and placebo in patients receiving methadone (P = 0.692). The safety profile of lubiprostone was unaffected by methadone use. The phase 3 study did not meet its primary efficacy end point. However, analysis of pooled data from all phase 3 studies in the OIC clinical development program, stratified by methadone opioid usage, confirmed that lubiprostone is effective for treatment of OIC in patients taking nonmethadone opioids; no safety concerns were identified based on the type of opioid used.

Effect of medical and surgical interventions on health-related quality of life in Parkinson's disease.

PubMed

Martinez-Martin, Pablo; Deuschl, Günther

2007-04-30

Motor-related parameters are the standard outcome parameters for treatment interventions. Nonetheless, subjective appraisals about the consequences of treatment on health-related quality of life (HRQoL) are meanwhile established and may uncover important aspects of interventions. We have reviewed the literature with a defined search strategy and collected 61 clinical trials, which have used HRQoL as a planned outcome parameter. The articles were rated similarly as for the Task Force report of the Movement Disorder Society on interventions for Parkinson's disease (PD), but the relevant outcome parameter was HRQoL. We found that unilateral pallidotomy, deep brain stimulation of the subthalamic nucleus, and rasagiline are efficacious to improve the HRQoL of PD patients. For many other interventions, the efficacy to improve HRQoL in the PD setting cannot be considered to be proven so far. HRQoL should be part of future trial designs and more research is necessary to understand the determinants of QoL in PD.

A nonrandomized, open-label study to evaluate the effect of nasal stimulation on tear production in subjects with dry eye disease.

PubMed

Friedman, Neil J; Butron, Karla; Robledo, Nora; Loudin, James; Baba, Stephanie N; Chayet, Arturo

2016-01-01

Dry eye disease (DED), a chronic disorder affecting the tear film and lacrimal functional unit, is a widely prevalent condition associated with significant burden and unmet treatment needs. Since specific neural circuits play an important role in maintaining ocular surface health, microelectrical stimulation of these pathways could present a promising new approach to treating DED. This study evaluated the efficacy and safety of nasal electrical stimulation in patients with DED. This prospective, open-label, single-arm, nonrandomized pilot study included 40 patients with mild to severe DED. After undergoing two screening visits, enrolled subjects were provided with a nasal stimulation device and instructed to use it at home four times daily (or more often as needed). Follow-up assessments were conducted up to day 180. The primary efficacy endpoint was the difference between unstimulated and stimulated tear production quantified by Schirmer scores. Additional efficacy endpoints included change from baseline in corneal and conjunctival staining, symptoms evaluated on a Visual Analog Scale, and Ocular Surface Disease Index scores. Safety parameters included adverse event (AE) rates, visual acuity, intraocular pressure, slit-lamp biomicroscopy, indirect ophthalmoscopy, and endoscopic nasal examinations. Mean stimulated Schirmer scores were significantly higher than the unstimulated scores at all visits, and corneal and conjunctival staining and symptom scores from baseline to day 180 were significantly reduced. No serious device-related AEs and nine nonserious AEs (three device-related) were reported. Intraocular pressure remained stable and most subjects showed little or no change in visual acuity at days 30 and 180. No significant findings from other clinical examinations were noted. Neurostimulation of the nasolacrimal pathway is a safe and effective means of increasing tear production and reducing symptoms of dry eye in patients with DED.

Lack of facilities rather than sociocultural factors as the primary barrier to physical activity among female Saudi university students.

PubMed

Samara, Anastasia; Nistrup, Anne; Al-Rammah, Tamader Y; Aro, Arja R

2015-01-01

The Kingdom of Saudi Arabia is experiencing a dramatic increase in physical inactivity, with women having higher levels of inactivity than men among all age groups. It is assumed that factors such as dress codes, restrictions on going outdoors, and conservative norms are the main reasons for women's low physical activity. Our aim was to explore the different parameters related to physical activity, including self-efficacy, as well as the perceived barriers to and benefits of physical activity in young Saudi females. Ninety-four first-year female Saudi university students in Riyadh, Kingdom of Saudi Arabia, participated in the present study in 2014. The students were from eight bachelor's programs in health and well-being, and each completed a questionnaire with questions divided into five parts as follows: 1) socioeconomic status, 2) physical activity, 3) self-efficacy 4) social factors, and 5) barriers and facilitators related to physical activity. The students exercised at home and alone, and there was low self-efficacy for physical activity (mean score =42±14). Among social factors, attending university was the only factor that hindered physical activity (32%). Physical activity was positively perceived overall (mean score =131±10). Students showed awareness of the benefits of physical activity for health and well-being. The most important barrier was the lack of designated areas available for physical activity. Students disagreed that family or the Islamic community were barriers to physical activity. The lack of facilities and lack of encouragement from the university, but not a lack of knowledge (a high level of knowledge is to be expected given their health and well-being studies backgrounds) and/or restrictions from families and society, seem to hinder female students' physical activity, at least young Saudi students.

Pilot study on the efficacy and safety of generic mycophenolate mofetil (Mycept) compared with Cellcept among incident low-risk primary kidney transplant recipients.

PubMed

Danguilan, R A; Lamban, A B; Luna, C A C; Bacinillo, M; Momongan, M I C

2014-01-01

The aim of this study was to establish the efficacy and safety of generic mycophenolate mofetil (Mycept) and determine the bioequivalence with Cellcept. This will provide patients an alternative cost-effective option that may improve compliance and long-term outcome. This was a comparative study between 2 nonconcurrent matched groups on Mycept and Cellcept. A total of 56 patients were included based on criteria (20 incidental patients on Mycept, matched to 20 historical patients on Cellcept, and 16 additional incidental patients on Cellcept). Patient and graft survival and safety parameters were reviewed at 6 months. Bioequivalence of Mycept with Cellcept was done by measuring area under the curve (AUC) of mycophenolic acid (MPA), maximum concentration, and time to maximum concentration for 16 patients in each group. Twenty incidental Mycept patients completed 6 months of follow-up. No significant difference was observed in survival (P = 1.0), graft function (P = .2320), and rejection episodes (P = .6250) between groups. The most common side effect of Mycept was hematologic and infectious. The MPA AUC of Mycept (37.38 ng/mL) was within the recommended MPA of 30-60 ng/mL. The maximum concentration (6.06 ng/mL) and time to maximum concentration (1.19 hours) of the 10 Mycept patients were not significantly different from the 10 Cellcept patients. There was no proven statistically significant difference between Mycept and Cellcept in efficacy and graft survival at 6 months after kidney transplantation. Hematologic side effects were noted more frequently among patients on Mycept and monitoring regularly is recommended. Copyright © 2014 Elsevier Inc. All rights reserved.

Therapeutic potential of medicinal marijuana: an educational primer for health care professionals.

PubMed

Mouhamed, Yara; Vishnyakov, Andrey; Qorri, Bessi; Sambi, Manpreet; Frank, Sm Signy; Nowierski, Catherine; Lamba, Anmol; Bhatti, Umrao; Szewczuk, Myron R

2018-01-01

With the proposed Canadian July 2018 legalization of marijuana through the Cannabis Act, a thorough critical analysis of the current trials on the efficacy of medicinal marijuana (MM) as a treatment option is necessary. This review is particularly important for primary care physicians whose patients may be interested in using MM as an alternative therapy. In response to increased interest in MM, Health Canada released a document in 2013 for general practitioners (GPs) as an educational tool on the efficacy of MM in treating some chronic and acute conditions. Although additional studies have filled in some of the gaps since the release of the Health Canada document, conflicting and inconclusive results continue to pose a challenge for physicians. This review aims to supplement the Health Canada document by providing physicians with a critical yet concise update on the recent advancements made regarding the efficacy of MM as a potential therapeutic option. An update to the literature of 2013 is important given the upcoming changes in legislation on the use of marijuana. Also, we briefly highlight the current recommendations provided by Canadian medical colleges on the parameters that need to be considered prior to authorizing MM use, routes of administration as well as a general overview of the endocannabinoid system as it pertains to cannabis. Lastly, we outline the appropriate medical conditions for which the authorization of MM may present as a practical alternative option in improving patient outcomes as well as individual considerations of which GPs should be mindful. The purpose of this paper is to offer physicians an educational tool that provides a necessary, evidence-based analysis of the therapeutic potential of MM and to ensure physicians are making decisions on the therapeutic use of MM in good faith.

Therapeutic potential of medicinal marijuana: an educational primer for health care professionals

PubMed Central

Frank, SM Signy; Nowierski, Catherine; Lamba, Anmol; Bhatti, Umrao; Szewczuk, Myron R

2018-01-01

With the proposed Canadian July 2018 legalization of marijuana through the Cannabis Act, a thorough critical analysis of the current trials on the efficacy of medicinal marijuana (MM) as a treatment option is necessary. This review is particularly important for primary care physicians whose patients may be interested in using MM as an alternative therapy. In response to increased interest in MM, Health Canada released a document in 2013 for general practitioners (GPs) as an educational tool on the efficacy of MM in treating some chronic and acute conditions. Although additional studies have filled in some of the gaps since the release of the Health Canada document, conflicting and inconclusive results continue to pose a challenge for physicians. This review aims to supplement the Health Canada document by providing physicians with a critical yet concise update on the recent advancements made regarding the efficacy of MM as a potential therapeutic option. An update to the literature of 2013 is important given the upcoming changes in legislation on the use of marijuana. Also, we briefly highlight the current recommendations provided by Canadian medical colleges on the parameters that need to be considered prior to authorizing MM use, routes of administration as well as a general overview of the endocannabinoid system as it pertains to cannabis. Lastly, we outline the appropriate medical conditions for which the authorization of MM may present as a practical alternative option in improving patient outcomes as well as individual considerations of which GPs should be mindful. The purpose of this paper is to offer physicians an educational tool that provides a necessary, evidence-based analysis of the therapeutic potential of MM and to ensure physicians are making decisions on the therapeutic use of MM in good faith. PMID:29928146

Advanced film-forming gel formula vs spring thermal water and white petrolatum as primary dressings after full-face ablative fractional CO2 laser resurfacing: a comparative split-face pilot study.

PubMed

Marini, L

2018-01-01

Aesthetically pleasing results and fast, uneventful recovery are highly desirable after rejuvenating ablative laser procedures. Wound dressings following ablative laser procedures should ideally improve and optimize the wound healing environment. The purpose of this comparative split-face, single-blinded, prospective observational study was to assess the efficacy and acceptability of two primary wound dressings immediately after a full-face fractional CO 2 laser resurfacing procedure. The assessments of an innovative film-forming dressing called Stratacel (SC) vs spring thermal water + Vaseline (V+) were conducted after a standardized, single-pass, full-face ablative fractional CO 2 laser skin resurfacing procedure. Clinical parameters, such as haemoglobin - HB; surface temperature - ST; micro-textural modifications - MT; superficial melanin - M; intrafollicular porphyrins - P, were assessed at different phases of the healing process using standardized, non-invasive technologies. Five female volunteers were enrolled in this inpatient, controlled pilot study. Most of the clinical parameters considered, including 3D surface texture analysis, revealed a better performance of SC vs. V+ during the early, more delicate phases of the healing process. This preliminary study, even if performed on a small number of volunteers, confirmed a definite advantage of the tested semipermeable film-forming formula (SC) over a more conventional postoperative skin care regime (V+). Clinical results could be explained by a better uniformity of distribution of SC over the micro-irregularities induced by ablative fractional CO 2 laser resurfacing. Its thin, semipermeable film might, in fact, act as an efficient, perfectly biocompatible, full contact, temporary skin barrier, able to protect extremely delicate healing surfaces from potential environmental irritations. © 2017 European Academy of Dermatology and Venereology.

Bioequivalence between two serum-free recombinant factor VIII preparations (N8 and ADVATE®)--an open-label, sequential dosing pharmacokinetic study in patients with severe haemophilia A.

PubMed

Martinowitz, U; Bjerre, J; Brand, B; Klamroth, R; Misgav, M; Morfini, M; Santagostino, E; Tiede, A; Viuff, D

2011-11-01

Recombinant coagulation factor VIII (rFVIII) concentrates provide a safe and efficacious replacement therapy for treatment and prevention of bleeding in patients with severe haemophilia A. The aim of this study was to compare the pharmacokinetic (PK) and safety profiles of two serum-free rFVIII products: N8, a new rFVIII manufactured by Novo Nordisk and Advate(®), a marketed product. Patients with severe haemophilia A with >150 exposure days to FVIII, without current or past inhibitors, were enrolled in an open-label, first human dose (FHD), multicentre trial. Twenty-three patients first received a single dose of 50 IU kg(-1) body weight Advate(®) followed by 50 IU kg(-1) body weight N8 at the next visit. A 4-day washout period was required prior to each dosing. Blood samples for PK and safety analyses were drawn prior to dosing and at intervals up until 48 h postdosing. The PK parameters were based on FVIII clotting activity (FVIII:C) measurements. Occurrence of adverse events was closely monitored. The mean profiles of FVIII:C and all primary and secondary parameters for Advate(®) and N8 were comparable. The 90% CI for the treatment ratio (Advate(®)/N8) for all primary endpoints (incremental recovery, t(1/2), AUC and Cl), and the secondary endpoints (AUC(last) and C(max)) were within the bioequivalence interval of 0.8-1.25. There were no safety concerns in the study and no reports of inhibitor formation in the 72-h period following exposure to a single N8 dose. In conclusion, N8 is bioequivalent to Advate(®). Furthermore, N8 is well tolerated in the FHD trial. © 2011 Blackwell Publishing Ltd.

A comparison of adverse event and fracture efficacy data for strontium ranelate in regulatory documents and the publication record

PubMed Central

Bolland, Mark J; Grey, Andrew

2014-01-01

Objective Recently, the European Medicines Agency reported that strontium ranelate increases myocardial infarction risk in postmenopausal women, 8.5 years after it was registered for use in osteoporosis. Unreported serious adverse events in clinical trials for other pharmaceuticals have been described in recent years. We assessed reporting of adverse events and fracture efficacy of strontium. Methods We compared data on adverse effects (myocardial infarction, venous thromboembolism and pulmonary embolism) and fracture efficacy of strontium in publicly available regulatory documents with data in publications retrieved from searching PubMed. Results We identified 5 regulatory documents and 9 primary publications of 7 randomised, placebo-controlled trials of strontium that reported relevant data. We identified several areas of concern in these reports: the increased risk of myocardial infarction with strontium was not identified in a pivotal phase 3 clinical trial despite specific regulatory review of cardiovascular events; data on myocardial infarction were not included in any primary publication; increased risks of venous thromboembolism and pulmonary embolism with strontium were not reported in either of the phase 3 clinical trials; data on venous thromboembolism were reported in only 5 of 9 primary publications, data on pulmonary embolism in only 2 of 9 primary publications, and either was discussed in <50% of subsequent review articles. There were differences in participant numbers, fracture cases and venous thromboembolism cases between regulatory documents and primary publications. Based on all available data from primary publications and regulatory documents, the number of fractures prevented by strontium use is similar to the number of extra cases of venous thromboembolism, pulmonary embolism and myocardial infarction caused by strontium use. Conclusions The risks of strontium use are similar to the benefits. Full disclosure of the clinical trial data and regulatory documents would allow clinicians and their patients to decide whether use of the drug is worthwhile. PMID:25293384

Short-Term Efficacy of an Innovative Mobile Phone Technology-Based Intervention for Weight Management for Overweight and Obese Adolescents: Pilot Study

PubMed Central

Guedes, Claudia M; Cooper, Bruce A; Lung, Audrey E

2017-01-01

Background In the United States, approximately one-third of adolescents are now overweight or obese, and one in six is obese. This financial cost and the larger nonfinancial costs of obesity make obesity prevention and management for adolescents imperative for the health of the nation. However, primary care visits are typically brief, and primary care providers may lack adequate resources to help overweight or obese adolescents to manage weight issues. To augment the efficacy of primary care visits for adolescent weight management, mobile phone technology can be used as an adjunct treatment that provides additional opportunities for encouraging improvement in lifestyle, attainment, and maintenance of healthy weight. Objective The purposes of this study were to (1) measure effects of an innovative mobile phone technology-based intervention for overweight and obese adolescents and to (2) examine the intervention’s feasibility for use in primary care clinics. Methods The mobile phone-based intervention had three components: use of the Fitbit Flex, participation in an online educational program, and receipt of biweekly text messages during the maintenance phase. A randomized controlled study design was utilized. Data regarding anthropometrics (body mass index [BMI] and waist-to-hip ratio), blood pressure, levels of physical and sedentary activity, diet, and self-efficacy regarding physical activity and diet were collected at baseline and at 3 and 6 months after the baseline assessment. Results A total of 40 adolescents participated in the study. At the 6-month follow-up visit, compared to participants in the control group, the mobile phone-based intervention participants had significant improvement in BMI (z=–4.37, P=.001), diastolic blood pressure (z=–3.23, P=.001), physical activity days per week (z=2.58, P=.01), TV and computer time (z=–3.34, P=.001), servings of fruits and vegetables per day (z=2.74, P=.006), servings of soda and sweetened drinks (z=–3.19, P=.001), physical activity self-efficacy (z=2.75, P=.006), and dietary self-efficacy (z=5.05, P=.001). Medium to large effect sizes were found in these outcome variables. Conclusions The use of mobile technologies may offer a practical, reliable adjunct to weight management for overweight and obese adolescents in busy primary care clinics serving adolescents. Trial Registration Clinicaltrials.gov NCT 01693250; https://clinicaltrials.gov/ct2/show/NCT01693250? term=Adolescent+ obesity+AND+mhealth&rank=5 (Archived by WebCite at ) PMID:28768612

Social Persuasions by Teachers as a Source of Student Self-Efficacy: The Moderating Role of Perceived Teacher Credibility

ERIC Educational Resources Information Center

Won, Sungjun; Lee, Sun-Young; Bong, Mimi

2017-01-01

The primary purpose of this study was to ascertain whether the degree to which Korean middle school students perceived their teachers to be credible made a difference in the effectiveness of teachers' persuasion as a source of students' academic self-efficacy. In the contexts of both general school learning and a specific subject of Korean…

The Role of Teachers' Emotional Intelligence and Self-Efficacy in Decreasing Students' Separation Anxiety Disorder

ERIC Educational Resources Information Center

Masoumparast, Shiva

2016-01-01

Background: teachers are as responsible for personal progress of children as parents are for their nurturing. The purpose of this study is to examine the role of EI and self-efficacy of teachers in reduced SAD of primary school students in Tehran. In other words, this study evaluates the effective role of teachers in reducing SAD in students.…

Effects of a School Guidance Curriculum on Postsecondary Education-Going Literacy, Postsecondary Education-Going Access Aspirations, and Career and College Readiness Self-Efficacy

ERIC Educational Resources Information Center

Martinez, Robert Richard, Jr.

2015-01-01

The primary purpose of this study was to evaluate the delivery and content of a set of classroom guidance lessons designed to enhance postsecondary education-going literacy, postsecondary education-going access aspirations, and career and college readiness self-efficacy of 9th grade students attending a high school in a southeastern rural…

Vaccine Efficacy and Affinity Maturation

NASA Astrophysics Data System (ADS)

Lee, Hayoun; Deem, Michael W.

2002-03-01

We propose macroscopic equations to describe variable vaccine efficacy between repeated vaccinee and first time vaccinee. The main ingredients are antigenic distance between epidemic strain and vaccne strain, and affinity maturation dynamics which differs in primary and second response. Increase of affinity by repeated vaccine leads to localization in immune space. This localization decreases the ability of the immune system to response to distant, but related epidemic strains.

Collaborative Curriculum Design to Increase Science Teaching Self-Efficacy: A Case Study

ERIC Educational Resources Information Center

Velthuis, Chantal; Fisser, Petra; Pieters, Jules

2015-01-01

The purpose of this study was to establish whether participation in a teacher design team (TDT) is an effective way to increase the science teaching self-efficacy of primary school teachers who vary in their levels of experience and interest in science. A TDT is a group of at least 2 teachers from the same or related subjects working together to…

Investigation of the Self-Efficacy Beliefs in Teaching Science and Attitudes towards Teaching Profession of the Candidate Teachers

ERIC Educational Resources Information Center

Uyanik, Gökhan

2016-01-01

The aim of this study is to investigate the attitudes of the primary school teacher candidates towards teaching profession and self-efficacy beliefs in teaching science. The research was conducted with a survey model. The sample of the study consisted of 182 teacher candidates who were studying at the 2015-2016 spring term from Kastamonu…

Clinical Practice Update: The Use of Per-Oral Endoscopic Myotomy in Achalasia: Expert Review and Best Practice Advice From the AGA Institute.

PubMed

Kahrilas, Peter J; Katzka, David; Richter, Joel E

2017-11-01

The purpose of this review is to describe a place for per-oral endoscopic myotomy (POEM) among the currently available robust treatments for achalasia. The recommendations outlined in this review are based on expert opinion and on relevant publications from PubMed and EMbase. The Clinical Practice Updates Committee of the American Gastroenterological Association proposes the following recommendations: 1) in determining the need for achalasia therapy, patient-specific parameters (Chicago Classification subtype, comorbidities, early vs late disease, primary or secondary causes) should be considered along with published efficacy data; 2) given the complexity of this procedure, POEM should be performed by experienced physicians in high-volume centers because an estimated 20-40 procedures are needed to achieve competence; 3) if the expertise is available, POEM should be considered as primary therapy for type III achalasia; 4) if the expertise is available, POEM should be considered as treatment option comparable with laparoscopic Heller myotomy for any of the achalasia syndromes; and 5) post-POEM patients should be considered high risk to develop reflux esophagitis and advised of the management considerations (potential indefinite proton pump inhibitor therapy and/or surveillance endoscopy) of this before undergoing the procedure. Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved.

[Pleural metastases of renal carcinoma].

PubMed

Giigoruk, O G; Lazarev, A F; Doroshenko, V S

2007-01-01

Metastases in renal carcinoma are diagnosed at initial diagnosis in 25% examinees. Traditional renal carcinoma has higher metastatic potential, is associated with worse survival of the patients compared to papillary cancer. We studied cytological characteristics of renal carcinoma metastases to the pleura in comparison with histological studies of the primary lesion using immunohistochemical findings. We examined cytologically pleural liquid in renal carcinoma metastases to the pleura in 6 patients (2.3% of carcinomatous pleuricies). High efficacy was shown by a cytocentrifuge CYTOSPIN-4. In 3 cases initial cancer was renal cell carcinoma, pleural exudation developed 2 years later, clear cell carcinoma appeared 6 years later and papillary cancer--10 years later. In the other 3 cases malignant cells were detected in new-onset cases. Renal carcinoma was diagnosed in one case. Cytological preparations were studied with identification of cytological signs typical for classic clear cell, granulocell and papillary renal cancer. Immunohistochemical examination of primary tumor lesion in the kidney discovered high proliferative activity of tumor cells by Ki-67 index to 5.28%. The tumors had solitary Bcl-2 positive cells. Expression of mutant p-53 took place in 0.93%. Her-2/neu hyperexpression was not found in the tumors of the above patients. Such immunohistochemical parameters point to poor prognosis. This is confirmed by renal carcinoma metastases to the pleura.

Efficacy of custom-made pressure clips for ear keloid treatment after surgical excision.

PubMed

Tanaydin, V; Beugels, J; Piatkowski, A; Colla, C; van den Kerckhove, E; Hugenholtz, G C G; van der Hulst, R R

2016-01-01

Mechanical pressure is increasingly applied as a means to prevent or treat keloid scars. The aim of this study is to analyze the long-term efficacy of our custom-molded pressure-adjustable earclips to prevent keloid recurrence after surgical excision. Using our custom-molded earclip, 88 patients who had undergone ear surgery for keloid scars were treated for 12 h a day for 6-18 months. The mean follow-up was 6.5 years. The primary outcome was the recurrence of keloids with patient satisfaction being the secondary outcome as assessed by Patient and Observer Scale (POSAS). Keloid scars did not recur in 70.5% of treated patients. The Fitzpatrick scale, which classifies human skin by type, was significantly different between the recurrence and nonrecurrence group. Differences in other patient characteristics were not found between both groups. All parameters mentioned in the POSAS patient scale drastically improved after therapy. There were no severe side effects observed after the therapy. Our pressure-adjustable earclip model is an effective tool in the prevention of ear keloid recurrence and is associated with high patient satisfaction. Its benefits should prompt further studies on its value as an adjuvant therapy to surgery in keloid treatment. Level III on the Evidence Rating Scale for Therapeutic Studies. Copyright © 2015 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

A randomized, double-blind, placebo-controlled, dose-ranging trial of tafenoquine for weekly prophylaxis against Plasmodium falciparum.

PubMed

Hale, Braden R; Owusu-Agyei, Seth; Fryauff, David J; Koram, Kwadwo A; Adjuik, Martin; Oduro, Abraham R; Prescott, W Roy; Baird, J Kevin; Nkrumah, Francis; Ritchie, Thomas L; Franke, Eileen D; Binka, Fred N; Horton, John; Hoffman, Stephen L

2003-03-01

Tafenoquine is a promising new 8-aminoquinoline drug that may be useful for malaria prophylaxis in nonpregnant persons with normal glucose-6-phosphate dehydrogenase (G6PD) function. A randomized, double-blind, placebo-controlled chemoprophylaxis trial was conducted with adult residents of northern Ghana to determine the minimum effective weekly dose of tafenoquine for the prevention of infection by Plasmodium falciparum. The primary end point was a positive malaria blood smear result during the 13 weeks of study drug coverage. Relative to the placebo, all 4 tafenoquine dosages demonstrated significant protection against P. falciparum infection: for 25 mg/week, protective efficacy was 32% (95% confidence interval [CI], 20%-43%); for 50 mg/week, 84% (95% CI, 75%-91%); for 100 mg/week, 87% (95% CI, 78%-93%); and for 200 mg/week, 86% (95% CI, 76%-92%). The mefloquine dosage of 250 mg/week also demonstrated significant protection against P. falciparum infection (protective efficacy, 86%; 95% CI, 72%-93%). There was little difference between study groups in the adverse events reported, and there was no evidence of a relationship between tafenoquine dosage and reports of physical complaints or the occurrence of abnormal laboratory parameters. Tafenoquine dosages of 50, 100, and 200 mg/week were safe, well tolerated, and effective against P. falciparum infection in this study population.

Clinical efficacy of crataegus extract WS 1442 in congestive heart failure NYHA class II.

PubMed

Zapfe jun, G

2001-07-01

In a randomised, placebo-controlled, double-blind clinical study the clinical efficacy and safety of Crataegus extract WS 1442, standardised to 18.75% oligomeric procyanidines, were investigated in 40 female and male outpatients suffering from congestive heart failure NYHA class II. Following a wash-out period of up to seven days, the patients were randomised to be treated for 12 weeks with either WS 1442 (3 x 1 capsule) or placebo. The primary outcome variable was exercise tolerance determined with bicycle exercise testing; as a secondary outcome variable the difference of the double product was calculated. On average, the exercise tolerance increased by 66.3 W x min (10.8%) in the WS 1442 group while in the placebo group a reduction of 105.3 W x min (16.9%) was measured. This difference between the groups was borderline statistically significant (p = 0.06). During the three month therapy the difference of the double product (heart rate x systolic blood pressure x 10(-2)) decreased by 14.4 mmHg s(-1) (26.8%) in the WS 1442 group and by 1.3 mmHg s(-1) (2.7%) in the placebo group, respectively. Recording of laboratory parameters and adverse events showed that WS 1442 was safe and well tolerated. The data show that Crataegus extract WS 1442 is clinically effective in patients with congestive heart failure corresponding to NYHA class II.

Prognosis estimation under the light of metabolic tumor parameters on initial FDG-PET/CT in patients with primary extranodal lymphoma

PubMed Central

Okuyucu, Kursat; Ozaydın, Sukru; Alagoz, Engin; Ozgur, Gokhan; Oysul, Fahrettin Guven; Ozmen, Ozlem; Tuncel, Murat; Ozturk, Mustafa; Arslan, Nuri

2016-01-01

Abstract Background Non-Hodgkin’s lymphomas arising from the tissues other than primary lymphatic organs are named primary extranodal lymphoma. Most of the studies evaluated metabolic tumor parameters in different organs and histopathologic variants of this disease generally for treatment response. We aimed to evaluate the prognostic value of metabolic tumor parameters derived from initial FDG-PET/CT in patients with a medley of primary extranodal lymphoma in this study. Patients and methods There were 67 patients with primary extranodal lymphoma for whom FDG-PET/CT was requested for primary staging. Quantitative PET/CT parameters: maximum standardized uptake value (SUVmax), average standardized uptake value (SUVmean), metabolic tumor volume (MTV) and total lesion glycolysis (TLG) were used to estimate disease-free survival and overall survival. Results SUVmean, MTV and TLG were found statistically significant after multivariate analysis. SUVmean remained significant after ROC curve analysis. Sensitivity and specificity were calculated as 88% and 64%, respectively, when the cut-off value of SUVmean was chosen as 5.15. After the investigation of primary presentation sites and histo-pathological variants according to recurrence, there is no difference amongst the variants. Primary site of extranodal lymphomas however, is statistically important (p = 0.014). Testis and central nervous system lymphomas have higher recurrence rate (62.5%, 73%, respectively). Conclusions High SUVmean, MTV and TLG values obtained from primary staging FDG-PET/CT are potential risk factors for both disease-free survival and overall survival in primary extranodal lymphoma. SUVmean is the most significant one amongst them for estimating recurrence/metastasis. PMID:27904443

Acellular vaccines for preventing whooping cough in children.

PubMed

Zhang, Linjie; Prietsch, Sílvio Om; Axelsson, Inge; Halperin, Scott A

2011-01-19

Routine use of whole-cell pertussis vaccines was suspended in some countries in the 1970s/1980s because of concerns about adverse effects. There was a resurgence of whooping cough. Acellular pertussis vaccines (containing purified or recombinant Bordetella pertussis antigens) were developed in the hope that they would be as effective but less reactogenic than the whole-cell vaccines. To assess the efficacy and safety of acellular pertussis vaccines in children. We searched the Cochrane Register of Controlled Trials (CENTRAL) (The Cochrane Library 2009, issue 2) which contains the Acute Respiratory Infections Group's Specialised Register; MEDLINE (1950 to April week 2 2009) and EMBASE (1974 to April 2009). Double-blind randomised efficacy and safety trials of acellular pertussis vaccines in children up to six years old, with active follow-up of participants and laboratory verification of pertussis cases. Two review authors independently performed data extraction and study quality assessment. Differences in trial design precluded pooling of the efficacy data. The safety data from individual trials were pooled using the Cochrane statistical package Review Manager 5. Six efficacy trials and 52 safety trials were included. The efficacy of multi-component (≥ 3) vaccines varied from 84% to 85% in preventing typical whooping cough, and from 71% to 78% in preventing mild pertussis disease. In contrast, the efficacy of one- and two-component vaccines varied from 59% to 75% against typical whooping cough, and from 13% to 54% against mild pertussis disease. Multi-component acellular vaccines is more effective than low-efficacy whole-cell vaccines, but may be less effective than the highest-efficacy whole-cell vaccines. Most systemic and local adverse events were significantly less common with acellular than with whole-cell pertussis vaccines for the primary series as well as for the booster dose. Multi-component acellular pertussis vaccines are effective, and show less adverse effects than whole-cell pertussis vaccines for the primary series as well as for booster doses.

Treating primary dysmenorrhoea with acupuncture: a narrative review of the relationship between acupuncture 'dose' and menstrual pain outcomes.

PubMed

Armour, Mike; Smith, Caroline A

2016-12-01

A number of randomised controlled trials have been performed to determine the effectiveness or efficacy of acupuncture in primary dysmenorrhoea. The objective of this review was to explore the relationship between the 'dose' of the acupuncture intervention and menstrual pain outcomes. Eight databases were systematically searched for trials examining penetrating body acupuncture for primary dysmenorrhoea published in English up to September 2015. Dose components for each trial were extracted, assessed by the two authors and categorised by neurophysiological dose (number of needles, retention time and mode of stimulation), cumulative dose (total number and frequency of treatments), needle location and treatment timing. Eleven trials were included. Components of acupuncture dose were well reported across all trials. The relationship between needle location and menstrual pain demonstrated conflicting results. Treatment before the menses appeared to produce greater reductions in pain than treatment starting at the onset of menses. A single needle during menses may provide greater pain reduction compared to multiple needles. Conversely, multiple needles before menses were superior to a single needle. Electroacupuncture may provide more rapid pain reduction compared to manual acupuncture but may not have a significantly different effect on overall menstrual pain. There appear to be relationships between treatment timing and mode of needle stimulation, and menstrual pain outcomes. Needle location, number of needles used and frequency of treatment show clear dose-response relationships with menstrual pain outcomes. Current research is insufficient to make definitive clinical recommendations regarding optimum dose parameters for treating primary dysmenorrhoea. 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/.

Oral tranexamic acid is equivalent to topical tranexamic acid without drainage in primary total hip arthroplasty: A double-blind randomized clinical trial.

PubMed

Luo, Ze-Yu; Wang, Duan; Meng, Wei-Kun; Wang, Hao-Yang; Pan, Hui; Pei, Fu-Xing; Zhou, Zong-Ke

2018-05-01

To compare the efficacy of multiple doses of oral tranexamic acid (TXA) with topical TXA administration in reducing blood loss following total hip arthroplasty (THA). In this double-blinded trial, 117 patients undergoing primary THA were randomized to receive 2 g TXA orally 2 h preoperatively, and two doses of 1 g TXA postoperatively (oral group) or 3 g of TXA topical administration in the operating room (topical group). The primary outcome was a reduction in hemoglobin concentration. Other outcomes-such as blood loss, TXA-related cost (¥), length of hospital stay (days), complications such as pulmonary thromboembolism (PE), deep vein thrombosis (DVT), and infection, blood coagulation and fibrinolysis, and hip function-were recorded. The mean reduction in hemoglobin level was similar between the oral and topical groups (3.07 g/dL compared with 3.12 g/dL; p = 0.85). Similarly, there was no significant difference in the mean total blood loss between oral and topical administration (863 mL compared with 902 mL; p = 0.62). Three patients received an allogeneic blood transfusion, including one patient in the oral group and two patients in the topical group (p = 0.55). The oral group had a significantly lower TXA-related cost than the topical group: ¥944 and ¥4359, respectively (p = 0.01). No PE, DVT, cardiac infarction or renal failure occurred during the 90-day follow-up. The coagulation and fibrinolysis parameters were similar between the two groups. Oral TXA is equivalent to topical TXA administration in the reduction of blood loss in the setting of primary THA without drainage. Copyright © 2018. Published by Elsevier Ltd.

The insertion torque-depth curve integral as a measure of implant primary stability: An in vitro study on polyurethane foam blocks.

PubMed

Di Stefano, Danilo Alessio; Arosio, Paolo; Gastaldi, Giorgio; Gherlone, Enrico

2017-07-08

Recent research has shown that dynamic parameters correlate with insertion energy-that is, the total work needed to place an implant into its site-might convey more reliable information concerning immediate implant primary stability at insertion than the commonly used insertion torque (IT), the reverse torque (RT), or the implant stability quotient (ISQ). Yet knowledge on these dynamic parameters is still limited. The purpose of this in vitro study was to evaluate whether an energy-related parameter, the torque-depth curve integral (I), could be a reliable measure of primary stability. This was done by assessing if (I) measurement was operator-independent, by investigating its correlation with other known primary stability parameters (IT, RT, or ISQ) by quantifying the (I) average error and correlating (I), IT, RT, and ISQ variations with bone density. Five operators placed 200 implants in polyurethane foam blocks of different densities using a micromotor that calculated the (I) during implant placement. Primary implant stability was assessed by measuring the ISQ, IT, and RT. ANOVA tests were used to evaluate whether measurements were operator independent (P>.05 in all cases). A correlation analysis was performed between (I) and IT, ISQ, and RT. The (I) average error was calculated and compared with that of the other parameters by ANOVA. (I)-density, IT-density, ISQ-density, and RT-density plots were drawn, and their slopes were compared by ANCOVA. The (I) measurements were operator independent and correlated with IT, ISQ, and RT. The average error of these parameters was not significantly different (P>.05 in all cases). The (I)-density, IT-density, ISQ-density, and RT-density curves were linear in the 0.16 to 0.49 g/cm³ range, with the (I)-density curves having a significantly greater slope than those regarding the other parameters (P≤.001 in all cases). The torque-depth curve integral (I) provides a reliable assessment of primary stability and shows a greater sensitivity to density variations than other known primary stability parameters. Copyright © 2017 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Safety and efficacy of low molecular weight heparins in children: a systematic review of the literature and meta-analysis of single-arm studies.

PubMed

Bidlingmaier, Christoph; Kenet, Gili; Kurnik, Karin; Mathew, Prasad; Manner, Daniela; Mitchell, Lesley; Krümpel, Anne; Nowak-Göttl, Ulrike

2011-10-01

Within the last two decades low molecular weight heparins (LMWH) have gained increasing widespread use as anticoagulants in children. The use of LMWH has been implemented into clinical care even though there is a lack of firm evidence on the efficacy and safety of LMWH in this population due to the absence of sufficiently powered randomized controlled trials. In the absence of clinical trials, we performed a meta-analysis of available single-arm studies using LMWH in children. A systematic search of electronic databases (Medline, EMBASE, OVID, Web of Science, The Cochrane Library) for studies published from 1980 to 2010 was conducted using keywords in combination both as MeSH terms and text words. Two authors independently screened citations and those meeting a priori defined inclusion criteria were retained. Data on year of publication, study design, country of origin, number of patients, ethnicity, venous thromboembolic events type, and frequency of recurrence and major bleedings were abstracted. Pooled incidence rates (IR) including 95% confidence intervals (95% CIs) on efficacy and safety data of LMWH administration on primary prophylaxis, as well as on secondary prophylaxis in children following symptomatic thromboembolism (TE) were shown. We included 2251 pediatric patients derived from 35 single-arm studies from 12 study countries who were eligible for analysis in the present systematic review. Pooled incidence rates (95% CI) to develop first TE on primary prophylaxis, further TE event on LMWH secondary prophylaxis, or a major bleeding event on LMWH were 0.047 (0.023 to 0.091), 0.052 (0.037 to 0.073) for efficacy, and 0.054 (0.039 to 0.074) for safety (treatment data only), respectively. Efficacy and safety data are comparable with adult data. The present systematic review suggests that use of LMWH in children as primary prophylaxis and in treatment of symptomatic thrombosis is effective and safe. However, properly designed randomized controlled trials are needed. © Thieme Medical Publishers.

Protective Effect of Contemporary Pertussis Vaccines: A Systematic Review and Meta-analysis.

PubMed

Fulton, T Roice; Phadke, Varun K; Orenstein, Walter A; Hinman, Alan R; Johnson, Wayne D; Omer, Saad B

2016-05-01

Acellular pertussis (aP) and whole-cell (wP) pertussis vaccines are presumed to have similar short-term (<3 years after completion of the primary series) efficacy. However, vaccine effect varies between individual pertussis vaccine formulations, and many originally studied formulations are now unavailable. An updated analysis of the short-term protective effect of pertussis vaccines limited to formulations currently on the market in developed countries is needed. We conducted a systematic review and meta-analysis of published studies that evaluated pertussis vaccine efficacy or effectiveness within 3 years after completion (>3 doses) of a primary series of a currently available aP or wP vaccine formulation. The primary outcome was based on the World Health Organization (WHO) clinical case definitions for pertussis. Study quality was assessed using the approach developed by the Child Health Epidemiology Research Group. We determined overall effect sizes using random-effects meta-analyses, stratified by vaccine (aP or wP) and study (efficacy or effectiveness) type. Meta-analysis of 2 aP vaccine efficacy studies (assessing the 3-component GlaxoSmithKline and 5-component Sanofi-Pasteur formulations) yielded an overall aP vaccine efficacy of 84% (95% confidence interval [CI], 81%-87%). Meta-analysis of 3 wP vaccine effectiveness studies (assessing the Behringwerke, Pasteur/Mérieux, and SmithKline Beecham formulations) yielded an overall wP vaccine effectiveness of 94% (95% CI, 88%-97%) (bothI(2)= 0%). Although all contemporary aP and wP formulations protect against pertussis disease, in this meta-analysis the point estimate for short-term protective effect against WHO-defined pertussis in young children was lower for currently available aP vaccines than wP vaccines. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

Correlates of Exercise Self-Efficacy in a Randomized Trial of Mind-Body Exercise in Patients with Chronic Heart Failure

PubMed Central

Yeh, Gloria Y.; Mu, Lin; Davis, Roger B.; Wayne, Peter M.

2015-01-01

Purpose Exercise self-efficacy is one of the strongest predictors of physical activity behavior. Prior literature suggests that tai chi, a mind-body exercise, may increase self-efficacy, however this is not well-studied. Little is known about the factors associated with development of exercise self-efficacy in a heart failure population. Methods We utilized data from a randomized controlled trial of 12 weeks group tai chi classes vs. education in patients with chronic heart failure (N=100). We used multivariable linear regression to explore possible correlates of change in exercise self-efficacy in the entire sample, and in the subgroup who received tai chi (N=50). Covariates included baseline quality-of-life, social support, functional parameters, physical activity, serum biomarkers, sociodemographics, and clinical HF parameters. Results Baseline 6-minute walk (β= −0.0003;SE 0.0001;p=0.02) and fatigue score (β= 0.03;SE 0.01;p=0.004) were significantly associated with change in self-efficacy, with those in the lowest tertile for 6-minute walk and higher tertiles for fatigue score having the greatest change. Intervention group was highly significant, with self-efficacy significantly improved in the tai chi group compared to the education control over 12 weeks (β= 0.39;SE: 0.11;p< 0.001). In the tai chi group alone, lower baseline oxygen consumption (β= −0.05;SE 0.01;p=0.001), decreased mood (β= −0.01;SE 0.003;p=0.004), and higher catecholamine level (epinephrine β= 0.003;SE 0.001;p=0.005) were significantly associated with improvements in self-efficacy. Conclusions In this exploratory analysis, our initial findings support the concept that interventions like tai chi may be beneficial in improving exercise self-efficacy, especially in patients with heart failure who are deconditioned, with lower functional status and mood. PMID:26959498

Correlates of Exercise Self-efficacy in a Randomized Trial of Mind-Body Exercise in Patients With Chronic Heart Failure.

PubMed

Yeh, Gloria Y; Mu, Lin; Davis, Roger B; Wayne, Peter M

2016-01-01

Exercise self-efficacy is one of the strongest predictors of physical activity behavior. Prior literature suggests that tai chi, a mind-body exercise, may increase self-efficacy; however, this is not extensively studied. Little is known about the factors associated with development of exercise self-efficacy in a population with heart failure. We utilized data from a randomized controlled trial of 12 weeks of group tai chi classes versus education in patients with chronic heart failure (n = 100). Multivariable linear regression was used to explore possible correlates of change in exercise self-efficacy in the entire sample and in the subgroup who received tai chi (n = 50). Covariates included baseline quality of life, social support, functional parameters, physical activity, serum biomarkers, sociodemographics, and clinical heart failure parameters. Baseline 6-minute walk (β=-0.0003, SE = 0.0001, P = .02) and fatigue score (β= 0.03, SE = 0.01, P = .004) were significantly associated with change in self-efficacy, with those in the lowest tertile for 6-minute walk and higher tertiles for fatigue score experiencing the greatest change. Intervention group assignment was highly significant, with self-efficacy significantly improved in the tai chi group compared to the education control over 12 weeks (β= 0.39, SE = 0.11, P < .001). In the tai chi group alone, lower baseline oxygen uptake (β=-0.05, SE = 0.01, P = .001), decreased mood (β=-0.01, SE = 0.003, P = .004), and higher catecholamine level (epinephrine β= 0.003, SE = 0.001, P = .005) were significantly associated with improvements in self-efficacy. In this exploratory analysis, our initial findings support the concept that interventions like tai chi may be beneficial in improving exercise self-efficacy, especially in patients with heart failure who are deconditioned, with lower functional status and mood.

Nonantimuscarinic treatment for overactive bladder: a systematic review.

PubMed

Olivera, Cedric K; Meriwether, Kate; El-Nashar, Sherif; Grimes, Cara L; Chen, Chi Chiung Grace; Orejuela, Francisco; Antosh, Danielle; Gleason, Jon; Kim-Fine, Shunaha; Wheeler, Thomas; McFadden, Brook; Balk, Ethan M; Murphy, Miles

2016-07-01

The purpose of the study was to determine the efficacy and safety of nonantimuscarinic treatments for overactive bladder. Medline, Cochrane, and other databases (inception to April 2, 2014) were used. We included any study design in which there were 2 arms and an n > 100, if at least 1 of the arms was a nonantimuscarinic therapy or any comparative trial, regardless of number, if at least 2 arms were nonantimuscarinic therapies for overactive bladder. Eleven reviewers double-screened citations and extracted eligible studies for study: population, intervention, outcome, effects on outcome categories, and quality. The body of evidence for categories of interventions were summarized and assessed for strength. Ninety-nine comparative studies met inclusion criteria. Interventions effective to improve subjective overactive bladder symptoms include exercise with heat and steam generating sheets (1 study), diaphragmatic (1 study), deep abdominal (1 study), and pelvic floor muscle training exercises (2 studies). Pelvic floor exercises are more effective in subjective and objective outcomes with biofeedback or verbal feedback. Weight loss with diet and exercise, caffeine reduction, 25-50% reduction in fluid intake, and pelvic floor muscle exercises with verbal instruction and or biofeedback were all efficacious. Botulinum toxin A improves urge incontinence episodes, urgency, frequency, quality of life, nocturia, and urodynamic testing parameters. Acupuncture improves quality of life and urodynamic testing parameters. Extracorporeal magnetic stimulation improves urodynamic parameters. Mirabegron improves daily incontinence episodes, nocturia, number of daily voids, and urine volume per void, whereas solabegron improves daily incontinence episodes. Short-term posterior tibial nerve stimulation is more efficacious than pelvic floor muscle training exercises and behavioral therapy for improving: urgency, urinary incontinence episodes, daily voids, volume per void, and overall quality of life. Sacral neuromodulation is more efficacious than antimuscarinic treatment for subjective improvement of overactive bladder and quality of life. Transvaginal electrical stimulation demonstrates subjective improvement in overactive bladder symptoms and urodynamic parameters. Multiple therapies, including physical therapy, behavioral therapy, botulinum toxin A, acupuncture, magnetic stimulation, mirabegron, posterior tibial nerve stimulation, sacral neuromodulation, and transvaginal electrical stimulation, are efficacious in the treatment of overactive bladder. Copyright © 2016 Elsevier Inc. All rights reserved.

The Self-Efficacy of Primary Teachers in Supporting the Inclusion of Children with Autism Spectrum Disorder

ERIC Educational Resources Information Center

Anglim, Johanna; Prendeville, Paula; Kinsella, William

2018-01-01

In the context of a trend towards inclusive practice in Irish primary schools, many teachers feel ill-equipped to cope with this new challenge. Scope exists within the Irish education system to transform mainstream schools into autistic spectrum disorder (ASD) friendly environments. Research into teacher perceptions of inclusion has found that…

Teachers' Computer Self-Efficacy and Their Use of Educational Technology

ERIC Educational Resources Information Center

Turel, Vehbi

2014-01-01

This study examined the use of educational technology by primary and subject teachers (i.e. secondary and high school teachers) in a small town in the eastern part of Turkey in the spring of 2012. The study examined the primary, secondary and high school teachers': (1) personal and computer related (demographic) characteristics; (2) their computer…

Prevention Rather than Cure? Primary or Secondary Intervention for Dealing with Media Exposure to Terrorism

ERIC Educational Resources Information Center

Slone, Michelle; Shoshani, Anat

2010-01-01

The authors examined the efficacy of primary versus secondary intervention in moderating state anxiety and state anger from media-based exposure to terrorism. Two hundred participants, allocated to a terrorism or nonterrorism media exposure and to antecedent or subsequent therapeutic or control intervention, were assessed for state anxiety and…

Effectiveness of a Career Development Course on Students' Job Search Skills and Self-Efficacy

ERIC Educational Resources Information Center

McDow, Lauren W.; Zabrucky, Karen M.

2015-01-01

In the current economic landscape, most college students' primary goal for obtaining an undergraduate degree is an increase in job opportunities and salary potential. Additionally, the average combined result of graduates' job searches is one of the primary factors in rankings of higher education institutions. In this study we assessed the…

Principals' Attitudes towards Risky Internet Use of Primary School Students: The Role of Occupational Factors

ERIC Educational Resources Information Center

Touloupis, Thanos; Athanasiades, Christina

2018-01-01

The present study aimed to investigate primary school principals' attitudes towards risky internet use of school-aged students and how occupational factors, such as work self-efficacy, job satisfaction, and burnout, may affect these attitudes especially in a context of economic crisis, which has adversely affected working conditions and duties of…

Efficacy of parent-delivered behavioral therapy for primary complex motor stereotypies.

PubMed

Specht, Matthew W; Mahone, E Mark; Kline, Tina; Waranch, Richard; Brabson, Laurel; Thompson, Carol B; Singer, Harvey S

2017-02-01

Primary complex motor stereotypies (CMS) are persistent, patterned, repetitive, rhythmic movements in young people with typical development. This study evaluated the efficacy of an instructional DVD as a home-based, parent-administered, behavioral therapy for primary CMS. Eighty-one children with primary CMS were enrolled. Primary outcome measures included the Stereotypy Severity Scale (SSS) - Motor and Impairment scores, and Stereotypy Linear Analog Scale (SLAS). Mean CMS onset was 13.4 months (SD 13.1). Eligibility required observed CMS. Psychiatric disorders were not exclusionary and a stable medication regimen was required. Intellectual disability, neurological disorder, autism spectrum disorder, and tics were exclusionary. Initial assessments were completed via REDCap before receipt of the DVD. Fifty-four of the 81 children (34 male, 20 female; mean age 8y 2mo, SD 1.42, range 7-14y) completed assessments at 1, 2, or 3 months after receiving the DVD. Reductions (baseline to last assessment) in SSS Motor, SSS Impairment, and SLAS scores (all p<0.001) represented change ratios of -15%, -24%, and a -20% respectively. Greatest relative treatment benefit was observed by younger children (ages 7-8y), and by 1 month after receipt of DVD, while a parent global assessment scale showed progressive improvement throughout the study. An instructional DVD for parent-delivered behavioral therapy was a safe, effective intervention for primary CMS. © 2016 Mac Keith Press.

Efficacy and Safety of Endovascular Intervention for the Management of Primary Entire-Inferior Vena Cava Occlusion

DOE Office of Scientific and Technical Information (OSTI.GOV)

Zhang, Qingqiao, E-mail: 1427286069@qq.com; Huang, Qianxin, E-mail: 18705206105@163.com; Shen, Bin, E-mail: 753021357@qq.com

PurposeThis study was designed to investigate the safety and efficacy of endovascular intervention for the treatment of primary entire-inferior vena cava (IVC) occlusion.MethodsEndovascular interventions were performed in six patients for the treatment of primary entire-IVC occlusion. IVC and hepatic venography were performed via the jugular and femoral veins. Balloon angioplasty was used to revascularize the hepatic vein and IVC and a stent was placed in the IVC to maintain patency. Postoperative color Doppler ultrasonography was performed at 1, 3, 6, and 12 months, and then annually, to monitor the patency of the hepatic vein and IVC.ResultsThe IVC and one or twomore » hepatic veins were successfully revascularized in five patients. Revascularization was successful in the right and left hepatic veins in one patient; however, IVC patency could not be established in this patient. Eleven Z-type, self-expanding stents were placed into the IVCs of five patients (three stents in two patients, two stents in two patients, and one stent in one patient). There were no instances of postoperative bleeding or mortality. Follow-up was conducted for 18–90 months (42.8 ± 26.5 months). None of the five patients suffered restenosis of the IVC or hepatic veins. However, there was one of the six cases of right hepatic vein restenosis at 18 months postprocedure that was revascularized after a second balloon dilatation.ConclusionsEndovascular intervention is safe and efficacious for the treatment of primary entire-IVC occlusion.« less

Efficacy and safety of fibrin sealant patch in the treatment of air leakage in thoracic surgery.

PubMed

Lopez, C; Facciolo, F; Lequaglie, C; Rendina, E A; Saita, S; Dell'Amore, D; Sollitto, F; Urciuoli, G; Loizzi, M; Cisternino, M L; Granone, P; Angelelli, A; Cardillo, G; Mucilli, F; Di Rienzo, G

2013-12-01

Air leakage represents a major problem in lung surgery. Absorbable fibrin sealant patch (AFSP), a collagen sponge coated with human fibrinogen and thrombin, can be used as an adjunct to primary stapling or suturing. This study compared the efficacy of AFSP with manual suturing after primary stapling. This was a prospective, multicenter, randomized study. Patients undergoing lobectomy, bilobectomy, anatomical segmentectomy for lung cancer or wedge resection for pulmonary metastasis with air leakage grade 1 or 2 according to Macchiarini scale after stapler suture were randomized to receive AFSP or standard surgical treatment (ST). The primary endpoint was the reduction of intraoperative air leakage intensity. Duration of postoperative air leakage and number of days until removal of last chest drain were secondary endpoints. Safety was recorded for all patients. A total of 346 patients were enrolled in 14 centres, 179 of whom received AFSP and 167 ST. Intraoperative air leak intensity was reduced in 90.5% of AFSP patients and 82% of ST patients (P=0.03). A significant reduction in postoperative air leakage duration was observed in the AFSP group (P=0.0437). The median number of days until removal of last drainage was 6 (3-37) in the AFSP group and 7 (2-27) in the ST (P=0.38). Occurrence of adverse events was comparable in both groups. AFSP was more efficacious than standard ST as an adjunct to primary stapling in reducing intraoperative air leakage intensity and duration of postoperative air leakage in patients undergoing pulmonary surgery. AFSP was well tolerated.

Improving Pain Care with Project ECHO in Community Health Centers.

PubMed

Anderson, Daren; Zlateva, Ianita; Davis, Bennet; Bifulco, Lauren; Giannotti, Tierney; Coman, Emil; Spegman, Douglas

2017-10-01

Pain is an extremely common complaint in primary care, and patient outcomes are often suboptimal. This project evaluated the impact of Project ECHO Pain videoconference case-based learning sessions on knowledge and quality of pain care in two Federally Qualified Health Centers. Quasi-experimental, pre-post intervention, with comparison group. Two large, multisite federally qualified health centers in Connecticut and Arizona. Intervention (N = 10) and comparison (N = 10) primary care providers. Primary care providers attended 48 weekly Project ECHO Pain sessions between January and December 2013, led by a multidisciplinary pain specialty team. Surveys and focus groups assessed providers' pain-related knowledge and self-efficacy. Electronic health record data were analyzed to evaluate opioid prescribing and specialty referrals. Compared with control, primary care providers in the intervention had a significantly greater increase in pain-related knowledge and self-efficacy. Providers who attended ECHO were more likely to use formal assessment tools and opioid agreements and refer to behavioral health and physical therapy compared with control providers. Opioid prescribing decreased significantly more among providers in the intervention compared with those in the control group. Pain is an extremely common and challenging problem, particularly among vulnerable patients such as those cared for at the more than 1,200 Federally Qualified Health Centers in the United States. In this study, attendance at weekly Project ECHO Pain sessions not only improved knowledge and self-efficacy, but also altered prescribing and referral patterns, suggesting that knowledge acquired during ECHO sessions translated into practice changes. © 2017 American Academy of Pain Medicine.

Efficacy of RADPAD® protection drape in reducing radiation exposure to the primary operator during Transcatheter Aortic Valve Implantation (TAVI).

PubMed

Sharma, Divyesh; Ramsewak, Adesh; Manoharan, Ganesh; Spence, Mark S

2016-02-01

The efficacy of RADPAD® (a sterile, lead-free drape) has been demonstrated to reduce the scatter radiation to the primary operator during fluoroscopic procedures. However, the use of the RADPAD® during TAVI procedures has not been studied. Transcatheter aortic valve implantation (TAVI) is now an established treatment for patients with symptomatic severe aortic stenosis who are deemed inoperable or at high risk for conventional surgical aortic valve replacement (AVR). Consequently the radiation exposure to the patient and the interventional team from this procedure has become a matter of interest and importance. Methods to reduce radiation exposure to the interventional team during this procedure should be actively investigated. In this single center prospective study, we determined the radiation dose during this procedure and the efficacy of RADPAD® in reducing the radiation dose to the primary operator. Fifty consecutive patients due to undergo elective TAVI procedures were identified. Patients were randomly assigned to undergo the procedure with or without the use of a RADPAD® drape. There were 25 patients in each group and dosimetry was performed at the left eye level of the primary operator. The dosimeter was commenced at the start of the procedure, and the dose was recorded immediately after the end of the procedure. Fluoroscopy times and DAP were also recorded prospectively. Twenty-five patients underwent transfemoral TAVI using a RADPAD® and 25 with no-RADPAD®. The mean primary operator radiation dose was significantly lower in the RADPAD group at 14.8 mSv vs. 24.3 mSv in the no-RADPAD group (P=0.008). There was no significant difference in fluoroscopy times or dose-area products between the two patient groups. The dose to the primary operator relative to fluoroscopy time (RADPAD: slope=0.325; no RADPAD: slope=1.148; analysis of covariance F=7.47, P=0.009) and dose area product (RADPAD: slope=0.0007; no RADPAD: slope=0.002; analysis of covariance F=7.38; P=0.009) was smaller in the RADPAD group compared to no-RADPAD group. Use of a RADPAD® significantly reduces radiation exposure to the primary operator during TAVI procedures.

Impact of an Interprofessional Primary Care Training on Fear of Cancer Recurrence on Clinicians' Knowledge, Self-Efficacy, Anticipated Practice Behaviors, and Attitudes Toward Survivorship Care.

PubMed

Berrett-Abebe, Julie; Cadet, Tamara; Nekhlyudov, Larissa; Vitello, Joan; Maramaldi, Peter

2018-02-10

There are an estimated 15.5 million cancer survivors in the United States, with numbers projected to increase. Many cancer survivors are receiving survivorship care in primary care settings, yet primary care providers report a need for additional training on addressing medical and psychosocial concerns of cancer survivors. This paper presents findings from a pilot study on the effectiveness of a novel training for interprofessional primary care providers on the clinically significant issue of fear of cancer recurrence. The on-site training was provided to a total of 46 participants, including physicians (61%), physician assistants (11%), nurse practitioners (7%), nurses (17%), and social workers (4%) in six different primary care practices. The average number of years of professional experience was 18.8, with standard deviation of 10.9. Results of paired-sample t tests indicated that the training increased knowledge and self-efficacy of providers in identifying and addressing FCR. The training was well-received by participants, who had high confidence in implementing practice behavior changes, although they also identified barriers. Results suggest the feasibility of a brief training for continuing education and have implications for models of care delivery in cancer survivorship.

The Efficacy of Thai Herbal Prasaplai Formula for Treatment of Primary Dysmenorrhea: A Short-Term Randomized Controlled Trial

PubMed Central

Vannabhum, Manmas; Wongwananuruk, Thanyarat; Suwannatrai, Ueamphon; Dangrat, Chongdee; Apichartvorakit, Angkana; Booranasubkajorn, Suksalin; Laohapand, Tawee; Akaraserenont, Pravit

2016-01-01

This study aims to compare the efficacy of pain relief between a specific Thai herbal Prasaplai formula (PPF) and placebo in patients with primary dysmenorrhea. Forty women with primary dysmenorrhea symptoms were randomized into two groups. The experimental group received PPF capsules 1000 mg orally three times per day before meals for three days starting from the first day of menstruation. The placebo group received placebo as the same dose and time. Average pain intensity from the first day to the third day of cycle significantly decreased in both groups (p < 0.001), but with no statistically significant difference between groups. Using a pre- and posttreatment difference in NRS of at least 2, a greater proportion of patients in PPF group experienced pain relief compared to placebo during the first and second day of period. A greater proportion of PPF group also experienced no pain compared to the placebo group on day 1 and day 3 by using multidimensional scoring. The PPF demonstrates pain relief activity when used during menstruation in primary dysmenorrhea patients, with no adverse effects. However, further studies are needed in order to assess the value of PPF as a long-term prophylaxis for primary dysmenorrhea. PMID:27829860

Efficacy and Safety of Doxepin 3 and 6 mg in a 35-day Sleep Laboratory Trial in Adults with Chronic Primary Insomnia

PubMed Central

Krystal, Andrew D.; Lankford, Alan; Durrence, H. Heith; Ludington, Elizabeth; Jochelson, Philip; Rogowski, Roberta; Roth, Thomas

2011-01-01

Study Objectives: To evaluate the efficacy and safety of doxepin (DXP) 3 mg and 6 mg in adults diagnosed with primary insomnia. Design and Methods: The study was a randomized, double-blind, parallel-group, placebo-controlled trial. Patients meeting DSM-IV-TR criteria for primary insomnia were randomized to 35 days of nightly treatment with DXP 3 mg (n = 75), DXP 6 mg (n = 73), or placebo (PBO; n = 73), followed by 2 nights of single-blind PBO to evaluate discontinuation (DC) effects. Efficacy was assessed using polysomnography (PSG) and patient reports. Efficacy data were examined for Night (N) 1, N15, and N29. Safety assessments were conducted throughout the study. Results: Compared with PBO, DXP 3 and 6 mg significantly improved wake time after sleep onset (WASO) on N1 (3 mg and 6 mg; P < 0.0001), N15 (3 mg P = 0.0025; 6 mg P = 0.0009), and N29 (3 mg P = 0.0248; 6 mg P = 0.0009), latency to persistent sleep (LPS) on N1 (3 mg P = 0.0047; 6 mg P = 0.0007), and total sleep time (TST) on N1 (3 mg and 6 mg P < 0.0001), N15 (6 mg P = 0.0035), and N29 (3 mg P = 0.0261; 6 mg P < 0.0001). In terms of early morning awakenings, DXP 3 and 6 mg demonstrated significant improvements in SE in the final quarter of the night on N1, N15, and N29, with the exception of 3 mg on N29 (P = 0.0691). Rates of discontinuation were low, and the safety profiles were comparable across the 3 treatment groups. There were no significant next-day residual effects, and there were no spontaneous reports of memory impairment, complex sleep behaviors, anticholinergic effects, weight gain, or increased appetite. Additionally, there was no evidence of rebound insomnia after DXP discontinuation. Conclusions: Five weeks of nightly administration of DXP 3 mg and 6 mg to adults with chronic primary insomnia resulted in significant and sustained improvements in sleep maintenance and early morning awakenings (with the exception of SE in the final quarter of the night on N29 for 3 mg [P = 0.0691]). These sleep improvements were not accompanied by next-day residual effects or followed by rebound insomnia or withdrawal effects upon discontinuation. These findings confirm the unique profile of sleep maintenance efficacy and safety of DXP observed in prior studies. Citation: Krystal AD; Lankford A; Durrence HH; Ludington E; Jochelson P; Rogowski R; Roth T. Efficacy and safety of doxepin 3 and 6 mg in a 35-day sleep laboratory trial in adults with chronic primary insomnia. SLEEP 2011;34(10):1433–1442. PMID:21966075

Tuning optical radiation for visual and nonvisual impact

NASA Astrophysics Data System (ADS)

Royer, Michael P.

2011-12-01

Spectral tuning---the allocation of radiant energy emitted by a lamp---is a fundamental element of illuminating engineering. Proper placement of optical radiation allows for reduced energy consumption, increased brightness perception, and improved color rendition. It can also result in lamps that have a greater impact on nonvisual human functions such as circadian rhythms, sleep, mood, and cognition. For an architectural lighting system, careful consideration must be given to all of these areas; recent advancements in understanding nonvisual photoreception must be balanced with the traditional emphasis on visual quality and energy efficiency. The three research projects described herein investigated spectral tuning by examining the effects of optical radiation or seeking ideal spectral power distributions. In all three cases, emphasis was placed on developing an architectural lighting system based on red, green, and blue (RGB) light emitting diodes (LEDs) that is capable of providing maximum stimulation to nonvisual systems while maintaining visual quality standards. In particular, the elderly were considered as a target population because they have an increased risk of developing disorders linked to illumination deficits. The three endeavors can be summarized as follows: Light Therapy for Seniors in Long-term Care AIM: To examine the effect of optical radiation on circadian rhythms, sleep, mood, and cognition for frail elderly in a long-term care environment. METHODOLOGY: A double-blind, placebo-controlled clinical trial of light therapy was conducted using circadian-effective short-wavelength (blue) optical radiation to treat a sample of residents recruited for participation without bias for existing medical diagnoses. KEY FINDINGS: Light therapy treatment improved cognitive functioning compared to placebo but no changes were detected in nighttime sleep statistics, reports of daytime sleepiness, circadian rhythms, or depression inventory parameters. Perceived Brightness of Trichromatic Light Sources AIM: To examine the effect of tuning optical radiation on brightness perception for younger (18-25 years of age) and older (50 years of age or older) observers. METHODOLOGY: Participants made forced-choice evaluations of the brightness of a full factorial of stimulus pairs selected from two groups of four metameric stimuli. The large-field stimuli were created by systematically varying either the red or the blue primary of an RGB LED mixture. KEY FINDINGS: Light stimuli of equal illuminance and chromaticity do not appear equally bright to either younger or older subjects. The rank-order of brightness is not predicted by any current model of human vision or theory of brightness perception including Scotopic to Photopic or Cirtopic to Photopic ratio theory, prime color theory, correlated color temperature, photometry, color quality metrics, linear brightness models, or color appearance models. Age may affect brightness perception when short-wavelength primaries are used, especially those with a peak wavelength shorter than 450 nm. Optimizing RGB LED Mixtures AIM: To investigate potential tradeoffs between luminous efficacy, nonvisual efficacy, and color quality of RGB LED mixtures when the peak wavelength and full with half maximum of the primaries are varied. To identify mixtures suitable for architectural lighting which provide increased circadian stimulation. METHODOLOGY: Software to calculate the properties of RGB LED mixtures matching the chromaticity of blackbody radiation was developed using Microsoft Excel and Visual Basic. Excel Solver was used to perform a series of optimization routines, identifying high-performing mixtures that were then compared to traditional lamps. KEY FINDINGS: Trichromatic mixtures suitable for architectural interiors can outperform traditional lamps when luminous efficacy, nonvisual efficacy, and color quality are considered simultaneously. However, misplacement of radiant energy can result in poor performing trichromatic systems. When radiant energy is manipulated, tradeoffs may occur between luminous efficacy, nonvisual efficacy, and color quality.

The Teachers' Research Self-Efficacy and Attitudes towards Scientific Research Based on Different Parameters: A Case Study of Agri Province

ERIC Educational Resources Information Center

Kurt, Murat

2015-01-01

The purpose of this study is to develop competencies of teachers, the coordination of the education, learning activities; in having access to innovations, developments and scientific studies in the literature. In addition, the purpose is to determine how teachers' scientific research self-efficacy and attitude towards the scientific research…

[The use and successfulness of minihygrometers for studying the ecology of house dust mites in Central Asia].

PubMed

Nazrullaeva, M F; Alekseev, A N

1991-01-01

The efficacy of minihygrometers in the study of bed microclimate (a shelter of dust ticks) has been assessed. Maximum difference between minihygrometer and August's psychrometer parameters reaches 0.5%. In all shelters of ticks humidity at night was higher than in the premises, which demonstrates the efficacy of the method used.

Efficacy and safety of biosimilar insulins compared to their reference products: A systematic review.

PubMed

Tieu, Carolyn; Lucas, Eleanor J; DePaola, Mindi; Rosman, Lori; Alexander, G Caleb

2018-01-01

For nearly a century, no generic form of insulin has been available in the United States. However, the first biosimilar insulin, Basaglar, was approved by the U.S. Food and Drug Administration in 2015, and subsequently Admelog and Lusduna in 2017. To summarize the scientific evidence comparing the safety, efficacy, pharmacokinetics, and pharmacodynamics of biosimilar and reference insulin products. We conducted a systematic review using PubMed, Cochrane, Embase, Latin America and Caribbean Health Sciences, South Asian Database of Controlled Clinical Trials, and IndiaMED from their inception through January 14, 2018. We included randomized controlled trials (RCTs) comparing safety, clinical efficacy, pharmacokinetics and pharmacodynamics of any biosimilar insulin with a reference product in adults regardless of sample size and location. Two researchers independently reviewed all titles, abstracts and text; extracted data; and performed quality assessments. Efficacy, safety, pharmacokinetics, and pharmacodynamics of biosimilar and reference insulin products. Of 6945 articles screened, 11 studies were included in the data synthesis. LY2963016, Basalog, Basalin, and MK-1293 were compared to Lantus while SAR342434 was compared to Humalog. Three trials enrolled healthy volunteers, five enrolled type 1 diabetics, and two enrolled type 2 diabetics. One study enrolled both healthy and type 1 diabetics. Of the eleven studies, six examined pharmacokinetic and/or pharmacodynamic parameters and five examined clinical efficacy and immunogenicity. All studies included adverse events. All PK and/or PD studies showed that comparable parameters of biosimilar and reference products were within the pre-specified equivalence margins. Clinical studies suggested similar clinical efficacy and immunogenicity. Adverse events were similar between the groups across all studies. Few published studies have compared biosimilar and reference insulins, though those that did suggest that the biosimilars have comparable safety and clinical efficacy as its reference product.

A comparative study of efficacy of emg bio-feedback and progressive muscular relaxation in tension headache.

PubMed

Gada, M T

1984-04-01

The aim of the present study was to find out efficacy of frontalis EMG Biofeedback therapy, deep muscular relaxation therapy and compare the efficacy of both in cases of tension headache. During two week basal-data recording period all patients were taught deep muscular relaxation by Jacobson's technique. Simultaneously patients were instructed to keep headache diary. Headache diary yielded three different parameters a) number of headache-free days per week, b) peak headache intensity (or each week and c) average daily headache activity score per week. These parameters were used to find out therapeutic efficacy of each treatment. Patients were randomly divided in two groups. EMG Biofeedback group was given frontalis EMG feedback through EMG J 33 muscle trainer of Cyborg Corporation (U.S.A.). Patients in each group were given 20 sessions (two sessions per week); each session lasting 30 minutes. Patients were instructed to practice at least one 30 minute session of relaxation at home. The data were subjected to statistical calculation. The results indicate that frontalis EMG Biofeedback therapy and deep muscle relaxation therapy are significantly effective in cases of tension headache. Both treatments are equally effective. The findings are discussed in relation to Indian situation.

A Comparison of Two Teaching Strategies on Nursing Students' Knowledge and Self-Efficacy Regarding Their Geriatric Nursing Care

ERIC Educational Resources Information Center

Diggle-Fox, B. Suzy

2013-01-01

The purpose of this study was to examine the effectiveness of the most frequently utilized teaching strategy of lecturing followed by discussion and to compare it with lecturing followed by role playing to determine how to best prepare nursing students both in terms of knowledge and self-efficacy. The primary goal of the study was to learn how to…

The Effect of Special Teaching Methods Class on the Level of Teachers' Self-Efficacy Perception of Pre-Service Teacher

ERIC Educational Resources Information Center

Gökdag Baltaoglu, Meltem

2015-01-01

The purpose of this study is to evaluate the change in the level of teachers' self-efficacy perception of primary school Social Studies pre-service teachers who take the special teaching methods class. Single group pretest-posttest model from pre-experimental patterns was applied in the research. The study group of the research consisted of 59…

Case-control study on prednisolone combined with ursodeoxycholic acid and azathioprine in pure primary biliary cirrhosis with high levels of immunoglobulin G and transaminases: efficacy and safety analysis.

PubMed

Fang, Yu-Qing; Lv, Dong-Xia; Jia, Wei; Li, Jun; Deng, Yong-Qiong; Wang, Yan; Yu, Min; Wang, Gui-Qiang

2014-10-01

To the best of our knowledge, this is the first study to address the use of glucocorticoids in the comparatively special population of pure primary biliary cirrhosis (PBC) patients who have high levels of immunoglobulin G (IgG) and transaminases but do not have PBC-autoimmune hepatitis overlap syndrome. Ursodeoxycholic acid (UDCA) is now assumed to be the standard therapy for PBC patients. However, patients treated with UDCA still have a risk of progression to cirrhosis and end-stage liver disease. The most recent European Association for the Study of the Liver guidelines of 2009 declared that further studies on glucocorticoid therapy in this disease should be a priority. Therefore, we designed this 3-year longitudinal retrospective study, which might provide deep insight into the treatment for PBC.The aim of this study was to assess whether the combination of prednisolone, UDCA, and azathioprine was superior to UDCA alone in these PBC patients.Sixty patients were enrolled in this study. Thirty-one patients underwent UDCA monotherapy, and 29 patients were treated with prednisolone, UDCA, and azathioprine. We analyzed their biochemistries, immune parameters, liver synthetic function, and noninvasive assessments of liver fibrosis, as well as treatment efficacy and adverse effects at baseline and at 1, 3, 6, 12, 24, and 36 months.Alkaline phosphatase (ALP), γ-glutamyl transpeptidase, alanine aminotransferase, and aspartate aminotransferase levels and the aspartate aminotransferase-to-platelet ratio index (APRI) and S-index improved dramatically in both groups, whereas IgG levels only decreased in the combination group (all P < 0.05). Albumin (ALB) levels decreased in the UDCA group but increased with the combination treatment at 36 months. Significant differences between the 2 groups were observed at 36 months in ALP (P = 0.005), IgG (P = 0.002), ALB (P = 0.002), APRI (P = 0.015), and S-index (P = 0.020). Prednisolone combined with UDCA and azathioprine showed a higher efficacy based on our new criteria.The combination of prednisolone, UDCA, and azathioprine is superior to UDCA alone for the treatment of pure PBC patients with high levels of IgG and transaminases. Side effects were minimal or absent.

Anesthetic efficacy of a repeated intraosseous injection following a primary intraosseous injection.

PubMed

Jensen, Joanne; Nusstein, John; Drum, Melissa; Reader, Al; Beck, Mike

2008-02-01

The purpose of this prospective, randomized, single-blinded study was to determine the anesthetic efficacy of a repeated intraosseous injection given 30 minutes after a primary intraosseous injection. Using a crossover design, 55 subjects randomly received a primary X-tip intraosseous injection (Dentsply Inc, York, PA) of 1.4 mL of 2% lidocaine with epinephrine (using the Wand; Milestone Scientific, Deerfield, IL) and a repeated intraosseous or mock injection at 30 minutes in two appointments. The first molar and adjacent teeth were pulp tested every 2 minutes for a total of 120 minutes. Success was defined as obtaining two consecutive 80 readings with the electric pulp tester. Success of the initial intraosseous injection was 100% for the first molar. The repeated intraosseous injection mimicked the initial intraosseous injection in terms of pulpal anesthesia and statistically provided another 15 minutes of pulpal anesthesia. In conclusion, using the methodology presented, repeating the intraosseous injection 30 minutes after an initial intraosseous injection will provide an additional 15 minutes of pulpal anesthesia.

Definitive fractionated re-irradiation for local recurrence following stereotactic body radiotherapy for primary lung cancer.

PubMed

Yoshitake, Tadamasa; Shioyama, Yoshiyuki; Nakamura, Katsumasa; Sasaki, Tomonari; Ohga, Saiji; Shinoto, Makoto; Terashima, Kotaro; Asai, Kaori; Matsumoto, Keiji; Hirata, Hideki; Honda, Hiroshi

2013-12-01

To retrospectively evaluate the efficacy and safety of definitive fractionated re-irradiation for local recurrence following stereotactic body radiotherapy (SBRT) for primary lung cancer. Between April 2003 and December 2011, 398 patients with primary lung tumor underwent SBRT at the Kyushu University Hospital, and 46 out of these developed local recurrence after SBRT. Definitive fractionated re-irradiation was performed for 17 out of the 46 patients. The median dose of re-irradiation was 60 Gy/ 30 fractions. Concurrent chemotherapy was given to four patients. The median follow-up duration was 12.6 months. At one year post-re-irradiation, local progression-free survival was 33.8%; progression-free survival, 30.9%; cause-specific survival, 79.3%; and overall survival, 74.7%. No severe adverse events were observed during the follow-up. Definitive fractionated re-irradiation is thought to be a safe alternative therapy for local recurrence following SBRT, although its efficacy may be not entirely satisfactory.

Efficacy and Safety of Fish Oil in Treatment of Knee Osteoarthritis.

PubMed

Peanpadungrat, Pornrawee

2015-04-01

To study efficacy and safety of fish oil in treatment of knee osteoarthritis. 75 participants had divided into three groups of 25 people to study efficacy results after taking fish oil 1,000 mg and 2,000 mg once a day for 8 weeks. 1,000 mg of fish oil have EPA 400 mg and DHA 200 mg. All participants had complete visual analog scale for measuring knee pain and knee function. They also had measured 100 meters walking velocity and three steps walking time before taking fish oil. Then they had re-measured all parameters again at 8-12 weeks after taking fish oil to compare the results. All parameters had statistically significant better differences in the group of participants who had taken fish oil when compared to the control group. The average score of patient's satisfaction was 9.06 of 10 and also by verbal response of 50 participants; everyone felt good and happy with fish oil. One participant had hematuriafrom silent CA bladder at 10th week but the other 49 participants were safe without any complications from fish oil. Fish oil 1,000-2,000 mg daily supplementation had significant efficacy to improve knee performance and also are safe in mild to moderate stages of knee osteoarthritics patients. However higher dose 2,000 mg of fish oil had not significant higher efficacy than 1,000 mg of fish oil.

Long-term efficacy and safety of safinamide as add-on therapy in early Parkinson's disease.

PubMed

Schapira, A H V; Stocchi, F; Borgohain, R; Onofrj, M; Bhatt, M; Lorenzana, P; Lucini, V; Giuliani, R; Anand, R

2013-02-01

Safinamide is an α-aminoamide with both dopaminergic and non-dopaminergic mechanisms of action in Phase III clinical development as a once-daily add-on to dopamine agonist (DA) therapy for early Parkinson's disease (PD). Study 017 was a 12-month, randomized, double-blind, placebo-controlled pre-planned extension study to the previously reported Study 015. Patients received safinamide 100 or 200 mg/day or placebo added to a single DA in early PD. The primary efficacy endpoint was the time from baseline (Study 015 randomization) to 'intervention', defined as increase in DA dose; addition of another DA, levodopa or other PD treatment; or discontinuation due to lack of efficacy. Safinamide groups were pooled for the primary efficacy endpoint analysis; post hoc analyses were performed on each separate dose group. Of the 269 patients randomized in Study 015, 227 (84%) enrolled in Study 017 and 187/227 (82%) patients completed the extension study. Median time to intervention was 559 and 466 days in the pooled safinamide and placebo groups, respectively (log-rank test; P = 0.3342). In post hoc analyses, patients receiving safinamide 100 mg/day experienced a significantly lower rate of intervention compared with placebo (25% vs. 51%, respectively) and a delay in median time to intervention of 9 days (P < 0.05; 240- to 540-day analysis). The pooled data from the safinamide groups failed to reach statistical significance for the primary endpoint of median time from baseline to additional drug intervention. Post hoc analyses indicate that safinamide 100 mg/day may be effective as add-on treatment to DA in PD. © 2012 The Author(s) European Journal of Neurology © 2012 EFNS.

Pairing motivational interviewing with a nutrition and physical activity assessment and counseling tool in pediatric clinical practice: a pilot study.

PubMed

Christison, Amy L; Daley, Brendan M; Asche, Carl V; Ren, Jinma; Aldag, Jean C; Ariza, Adolfo J; Lowry, Kelly W

2014-10-01

Recommendations to screen and counsel for lifestyle behaviors can be challenging to implement during well-child visits in the primary care setting. A practice intervention was piloted using the Family Nutrition and Physical Activity (FNPA) Screening Tool paired with a motivational interviewing (MI)-based counseling tool during well-child visits. Acceptability and feasibility of this intervention were assessed. Its impact on parent-reported obesigenic behavior change and provider efficacy in lifestyle counseling were also examined. This was an observational study in a pediatric primary care office. During well-child visits of 100 patients (ages 4-16 years), the FNPA tool was implemented and providers counseled patients in an MI-consistent manner based on its results. Duration of implementation, patient satisfaction of the intervention, and success of stated lifestyle goals were measured. Provider self-efficacy and acceptability were also surveyed. The FNPA assessment was efficient to administer, requiring minutes to complete and score. Patient acceptability was high, ranging from 4.0 to 4.8 on a 5-point scale. Provider acceptability was good, with the exception of duration of counseling; self-efficacy in assessing patient "readiness for change" was improved. Parent-reported success of primary lifestyle goal was 68% at 1 month and 46% at 6 months. The FNPA assessment with an MI-based counseling tool shows promise as an approach to identify and address obesigenic behaviors during pediatric well-child visits. It has the potential to improve provider efficacy in obesity prevention and also influence patient health behaviors, which can possibly impact childhood excessive weight gain. After refinement, this practice intervention will be used in a larger trial.

Intranasal carbetocin reduces hyperphagia in individuals with Prader-Willi syndrome.

PubMed

Dykens, Elisabeth M; Miller, Jennifer; Angulo, Moris; Roof, Elizabeth; Reidy, Michael; Hatoum, Hind T; Willey, Richard; Bolton, Guy; Korner, Paul

2018-06-21

Prader-Willi syndrome (PWS) is a genetic neurodevelopmental disorder of life-threatening hyperphagia, obesity, intellectual deficits, compulsivity, and other behavioral problems. The efficacy and safety of i.n. carbetocin, an oxytocin analog, was evaluated in a prospective, randomized, double-blinded trial in adolescents with PWS. Eligible patients aged 10-18 years with genetically confirmed PWS were randomized (1:1) to i.n. carbetocin or placebo 3 times daily for 14 days. The primary efficacy endpoint was change in parent/caregiver-rated Hyperphagia in PWS Questionnaire-Responsiveness (HPWSQ-R) total score. Secondary efficacy endpoints included HPWSQ-R behavior, drive, and severity domains; clinician-rated HPWSQ; Children's Yale-Brown Obsessive-Compulsive Severity Scale; food domain of the Reiss Profile; and Clinical Global Impression-Improvement scale. Endpoints were assessed using analysis of covariance. Relationship between primary and secondary endpoints was assessed using Pearson correlation coefficients. Safety was assessed throughout the study. Demographics and clinical characteristics were similar between treatment groups (carbetocin, n = 17; placebo, n = 20). Patients receiving carbetocin had statistically significant reductions in HPWSQ-R total score at study end (-15.6) versus patients receiving placebo (-8.9; P = 0.029); several secondary efficacy endpoints also demonstrated significant differences (P < 0.05). Treatment effects for the primary and secondary endpoints were highly correlated (P ≤ 0.0001). Incidence of adverse events (AEs) was similar between treatment groups. I.n. carbetocin was well tolerated and improved hyperphagia and behavioral symptoms of PWS. ClinicalTrials.gov: NCT01968187FUNDING. The study was funded by Ferring Pharmaceuticals. Recruitment was aided by ongoing work in PWS performed through Eunice Kennedy Shriver National Institute of Child Health and Human Development grant U54 HD083211.

Photodynamic therapy augments the efficacy of oncolytic vaccinia virus against primary and metastatic tumours in mice

PubMed Central

Gil, M; Bieniasz, M; Seshadri, M; Fisher, D; Ciesielski, M J; Chen, Y; Pandey, R K; Kozbor, D

2011-01-01

Background: Therapies targeted towards the tumour vasculature can be exploited for the purpose of improving the systemic delivery of oncolytic viruses to tumours. Photodynamic therapy (PDT) is a clinically approved treatment for cancer that is known to induce potent effects on tumour vasculature. In this study, we examined the activity of PDT in combination with oncolytic vaccinia virus (OVV) against primary and metastatic tumours in mice. Methods: The effect of 2-[1-hexyloxyethyl-]-2-devinyl pyropheophorbide-a (HPPH)-sensitised-PDT on the efficacy of oncolytic virotherapy was investigated against subcutaneously implanted syngeneic murine NXS2 neuroblastoma and human FaDu head and neck squamous cell carcinoma xenografts in nude mice. Treatment efficacy was evaluated by monitoring tumour growth and survival. The effects of combination treatment on vascular function were examined using magnetic resonance imaging (MRI) and immunohistochemistry, whereas viral replication in tumour cells was analysed by a standard plaque assay. Normal tissue phototoxicity following PDT-OV treatment was studied using the mouse foot response assay. Results: Combination of PDT with OVV resulted in inhibition of primary and metastatic tumour growth compared with either monotherapy. PDT-induced vascular disruption resulted in higher intratumoural viral titres compared with the untreated tumours. Five days after delivery of OVV, there was a loss of blood flow to the interior of tumour that was associated with infiltration of neutrophils. Administration of OVV did not result in any additional photodynamic damage to normal mouse foot tissue. Conclusion: These results provide evidence into the usefulness of PDT as a means of enhancing intratumoural replication and therapeutic efficacy of OV. PMID:21989183

Internet versus face-to-face group cognitive-behavioral therapy for fibromyalgia: A randomized control trial.

PubMed

Vallejo, Miguel A; Ortega, José; Rivera, Javier; Comeche, María I; Vallejo-Slocker, Laura

2015-09-01

The aim of this study was to explore the effectiveness of Internet-delivered cognitive-behavioral therapy (iCBT) in treating fibromyalgia (FM) compared with an identical protocol using conventional group face-to-face CBT. Sixty participants were assigned to either (a) the waiting list group, (b) the CBT group, or (c) the iCBT group. The groups were assessed at baseline, after 10 weeks of treatment, and at 3-, 6-, and 12-month follow-ups. The primary outcome measured was the impact of FM on daily functioning, as measured by the Fibromyalgia Impact Questionnaire (FIQ). The secondary outcomes were psychological distress, depression, and cognitive variables, including self-efficacy, catastrophizing, and coping strategies. In post-treatment, only the CBT group showed improvement in the primary outcome. The CBT and iCBT groups both demonstrated improvement in psychological distress, depression, catastrophizing, and utilizing relaxation as a coping strategy. The iCBT group showed an improvement in self-efficacy that was not obtained in the CBT group. CBT and iCBT were dissimilar in efficacy at follow-up. The iCBT group members improved their post-treatment scores at their 6- and 12-month follow-ups. At the 12-month follow-up, the iCBT group showed improvement over their primary outcome and catastrophizing post-treatment scores. A similar effect of CBT was expected, but the positive results observed at the post-treatment assessment were not maintained at follow-up. The results suggest that some factors, such as self-efficacy or catastrophizing, could be enhanced by iCBT. Specific characteristics of iCBT may potentiate the social support needed to improve treatment adherence. Copyright © 2015 Elsevier Ltd. All rights reserved.

Rivaroxaban for Thromboprophylaxis among Patients Recently Hospitalized for Acute Infectious Diseases: A Subgroup Analysis of the MAGELLAN Study.

PubMed

Cohoon, Kevin P; De Sanctis, Yoriko; Haskell, Lloyd; McBane, Robert D; Spiro, Theodore E

2018-05-12

Despite the well-established association between infection and venous thromboembolism (VTE), there are few data specifically assessing the efficacy and safety of the VTE prophylaxis strategies for patients hospitalized for acute infectious diseases. Estimate incidence of VTE and bleeding outcomes comparing prolonged prophylaxis with rivaroxaban 10 mg daily for 35 days with enoxaparin 40 mg daily for 10 days. A subgroup analysis of patients hospitalized for acute infectious diseases in the MAGELLAN trial was performed. The primary efficacy outcome was the composite of asymptomatic proximal or symptomatic VTE at days 10 and 35. The principal safety outcome was the composite of major or clinically relevant non-major bleeding. 3173 patients with acute infectious diseases leading to hospitalization were randomized to either rivaroxaban (n=1585) or enoxaparin/placebo (n=1588) and received at least one dose of study medication. At day 10, primary composite efficacy outcomes did not differ between prophylaxis strategies (rivaroxaban 2.7% and enoxaparin 3.7%). At day 35, VTE events were lower for rivaroxaban (4.2%) compared to enoxaparin (6.6%) (Relative risk [RR] 0.64; 95%CI, 0.45, 0.92). Patients with pulmonary infections randomized to rivaroxaban had lower incidence of VTE both at 10 days (RR 0.50, 95%CI 0.28, 0.90) and 35 days (RR 0.54, 95%CI 0.33, 0.87). Primary safety outcome events were higher for those receiving rivaroxaban (RR 2.42, 95%CI 1.60, 3.66). Prolonged rivaroxaban prophylaxis reduced VTE in patients hospitalized for acute infectious diseases particularly involving the lungs. Efficacy benefits were, in part, offset by bleeding outcomes. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Characterizing the efficacy of cancer therapeutics in patient-derived xenograft models of metastatic breast cancer.

PubMed

Turner, Tia H; Alzubi, Mohammad A; Sohal, Sahib S; Olex, Amy L; Dozmorov, Mikhail G; Harrell, J Chuck

2018-03-12

Basal-like breast cancers are aggressive and often metastasize to vital organs. Treatment is largely limited to chemotherapy. This study aims to characterize the efficacy of cancer therapeutics in vitro and in vivo within the primary tumor and metastatic setting, using patient-derived xenograft (PDX) models. We employed two basal-like, triple-negative PDX models, WHIM2 and WHIM30. PDX cells, obtained from mammary tumors grown in mice, were treated with twelve cancer therapeutics to evaluate their cytotoxicity in vitro. Four of the effective drugs-carboplatin, cyclophosphamide, bortezomib, and dacarbazine-were tested in vivo for their efficacy in treating mammary tumors, and metastases generated by intracardiac injection of tumor cells. RNA sequencing showed that global gene expression of PDX cells grown in the mammary gland was similar to those tested in culture. In vitro, carboplatin was cytotoxic to WHIM30 but not WHIM2, whereas bortezomib, dacarbazine, and cyclophosphamide were cytotoxic to both lines. Yet, these drugs were ineffective in treating both primary and metastatic WHIM2 tumors in vivo. Carboplatin and cyclophosphamide were effective in treating WHIM30 mammary tumors and reducing metastatic burden in the brain, liver, and lungs. WHIM2 and WHIM30 metastases showed distinct patterns of cytokeratin and vimentin expression, regardless of treatment, suggesting that different tumor cell subpopulations may preferentially seed in different organs. This study highlights the utility of PDX models for studying the efficacy of therapeutics in reducing metastatic burden in specific organs. The differential treatment responses between two PDX models of the same intrinsic subtype, in both the primary and metastatic setting, recapitulates the challenges faced in treating cancer patients and highlights the need for combination therapies and predictive biomarkers.

Evaluation of standardized sample collection, packaging, and decontamination procedures to assess cross-contamination potential during Bacillus anthracis incident response operations

PubMed Central

Calfee, M. Worth; Tufts, Jenia; Meyer, Kathryn; McConkey, Katrina; Mickelsen, Leroy; Rose, Laura; Dowell, Chad; Delaney, Lisa; Weber, Angela; Morse, Stephen; Chaitram, Jasmine; Gray, Marshall

2016-01-01

Sample collection procedures and primary receptacle (sample container and bag) decontamination methods should prevent contaminant transfer between contaminated and non-contaminated surfaces and areas during bio-incident operations. Cross-contamination of personnel, equipment, or sample containers may result in the exfiltration of biological agent from the exclusion (hot) zone and have unintended negative consequences on response resources, activities and outcomes. The current study was designed to: (1) evaluate currently recommended sample collection and packaging procedures to identify procedural steps that may increase the likelihood of spore exfiltration or contaminant transfer; (2) evaluate the efficacy of currently recommended primary receptacle decontamination procedures; and (3) evaluate the efficacy of outer packaging decontamination methods. Wet- and dry-deposited fluorescent tracer powder was used in contaminant transfer tests to qualitatively evaluate the currently-recommended sample collection procedures. Bacillus atrophaeus spores, a surrogate for Bacillus anthracis, were used to evaluate the efficacy of spray- and wipe-based decontamination procedures. Both decontamination procedures were quantitatively evaluated on three types of sample packaging materials (corrugated fiberboard, polystyrene foam, and polyethylene plastic), and two contamination mechanisms (wet or dry inoculums). Contaminant transfer results suggested that size-appropriate gloves should be worn by personnel, templates should not be taped to or removed from surfaces, and primary receptacles should be selected carefully. The decontamination tests indicated that wipe-based decontamination procedures may be more effective than spray-based procedures; efficacy was not influenced by material type but was affected by the inoculation method. Incomplete surface decontamination was observed in all tests with dry inoculums. This study provides a foundation for optimizing current B. anthracis response procedures to minimize contaminant exfiltration. PMID:27362274

Systematic review with meta-analysis: the efficacy of a second anti-TNF in patients with inflammatory bowel disease whose previous anti-TNF treatment has failed.

PubMed

Gisbert, J P; Marín, A C; McNicholl, A G; Chaparro, M

2015-04-01

One-third of patients with Crohn's disease (CD) or ulcerative colitis (UC) receiving anti-TNFs do not respond to treatment, and a relevant proportion experience loss of response or intolerance. To investigate the efficacy and safety of a second anti-TNF agent after primary/secondary failure or intolerance to a first drug. studies evaluating the efficacy of infliximab (IFX), adalimumab (ADA) and certolizumab-pegol (CZP) as the second anti-TNF in CD or UC. Bibliographical searches (PubMed/Embase). percentage of response/remission; the meta-analysis was performed using the inverse variance method. We included 46 studies (37 CD, 8 UC, 1 pouchitis). The CD studies comprised 32 switching IFX→ADA, 4 IFX→CZP and 1 ADA→IFX. Overall, the second anti-TNF after the failure of IFX in CD induced remission in 43% and response in 63% of patients. The remission rate was higher when the reason to withdraw the first anti-TNF was intolerance (61%) than after secondary (45%) or primary failure (30%); response rates were, respectively, 72%, 62% and 53%. All UC studies switched IFX→ADA, six of them reporting remission rates ranging from 0% to 50%. Adverse events rate ranged from 0% to 81% in CD, most of them mild (serious adverse event 0-21%, discontinuation rate <20%). The efficacy of a second anti-TNF in CD patients largely depends on the cause for switching. The remission rate is higher when the reason to withdraw the first anti-TNF is intolerance (61%), compared with secondary (45%) or primary failure (30%). Further studies of switch ADA→IFX are needed to evaluate this strategy. PROSPERO-registry-number: CRD42014012943. © 2015 John Wiley & Sons Ltd.

Evaluation of standardized sample collection, packaging, and decontamination procedures to assess cross-contamination potential during Bacillus anthracis incident response operations.

PubMed

Calfee, M Worth; Tufts, Jenia; Meyer, Kathryn; McConkey, Katrina; Mickelsen, Leroy; Rose, Laura; Dowell, Chad; Delaney, Lisa; Weber, Angela; Morse, Stephen; Chaitram, Jasmine; Gray, Marshall

2016-12-01

Sample collection procedures and primary receptacle (sample container and bag) decontamination methods should prevent contaminant transfer between contaminated and non-contaminated surfaces and areas during bio-incident operations. Cross-contamination of personnel, equipment, or sample containers may result in the exfiltration of biological agent from the exclusion (hot) zone and have unintended negative consequences on response resources, activities and outcomes. The current study was designed to: (1) evaluate currently recommended sample collection and packaging procedures to identify procedural steps that may increase the likelihood of spore exfiltration or contaminant transfer; (2) evaluate the efficacy of currently recommended primary receptacle decontamination procedures; and (3) evaluate the efficacy of outer packaging decontamination methods. Wet- and dry-deposited fluorescent tracer powder was used in contaminant transfer tests to qualitatively evaluate the currently-recommended sample collection procedures. Bacillus atrophaeus spores, a surrogate for Bacillus anthracis, were used to evaluate the efficacy of spray- and wipe-based decontamination procedures. Both decontamination procedures were quantitatively evaluated on three types of sample packaging materials (corrugated fiberboard, polystyrene foam, and polyethylene plastic), and two contamination mechanisms (wet or dry inoculums). Contaminant transfer results suggested that size-appropriate gloves should be worn by personnel, templates should not be taped to or removed from surfaces, and primary receptacles should be selected carefully. The decontamination tests indicated that wipe-based decontamination procedures may be more effective than spray-based procedures; efficacy was not influenced by material type but was affected by the inoculation method. Incomplete surface decontamination was observed in all tests with dry inoculums. This study provides a foundation for optimizing current B. anthracis response procedures to minimize contaminant exfiltration.

Dose-response relationship of a new Timothy grass pollen allergoid in comparison with a 6-grass pollen allergoid.

PubMed

Pfaar, O; Hohlfeld, J M; Al-Kadah, B; Hauswald, B; Homey, B; Hunzelmann, N; Schliemann, S; Velling, P; Worm, M; Klimek, L

2017-11-01

Subcutaneous allergen immunotherapy with grass pollen allergoids has been proven to be effective and safe in the treatment of patients with allergic rhinoconjunctivitis. Based on the extensive cross-reactivity among Pooideae species, it has been suggested that grass pollen extracts could be prepared from a single species, rather than from a multiple species mixture. To find the optimal dose of a Phleum pratense (P. pratense) allergoid preparation and compare its efficacy and safety to a 6-grass pollen allergoid preparation. In this double-blind, placebo-controlled study (EudraCT: 2011-000674-58), three doses of P. pratense allergoid (1800 therapeutic units (TU), standard-dose 6000 TU and 18 000 TU) were compared with placebo and the marketed 6-grass pollen allergoid (6000 TU). In a pre-seasonal dosing regimen, 102 patients were randomized to five treatment groups and received nine subcutaneous injections. The primary efficacy endpoint was the change in weal size (late-phase reaction [LPR]) in response to the intracutaneous testing (ICT) before and after treatment, comparing the active allergoids to placebo. Secondary outcomes were the change in Total Nasal Symptom Score (TNSS) assessed in the allergen exposure chamber (AEC), the changes in P. pratense-serum-specific IgG 4 and the incidence of adverse events (AEs). All three doses of the P. pratense and the 6-grass pollen allergoid preparations were significantly superior to placebo for the primary outcome, whereas there were no significant differences in the change in TNSS. Compared to the standard-dose, the high-dose of P. pratense did not produce any additional significant benefit, but showed a slight increase in AEs. Yet this increase in AEs was lower than for the 6-grass pollen preparation. The standard-dose of the new P. pratense allergoid was comparable to the marketed 6-grass pollen preparation at equal dose for the parameters measured. © 2017 The Authors. Clinical & Experimental Allergy Published by John Wiley & Sons Ltd.

The efficacy of modified direct lateral versus posterior approach on gait function and hip muscle strength after primary total hip arthroplasty at 12months follow-up. An explorative randomised controlled trial.

PubMed

Rosenlund, Signe; Broeng, Leif; Overgaard, Søren; Jensen, Carsten; Holsgaard-Larsen, Anders

2016-11-01

The lateral and the posterior approach are the most commonly used procedures for total hip arthroplasty. Due to the detachment of the hip abductors, lateral approach is claimed to cause reduced hip muscle strength and altered gait pattern. However, this has not been investigated in a randomised controlled trial. The aim was to compare the efficacy of total hip arthroplasty performed by lateral or posterior approach on gait function and hip muscle strength up to 12months post-operatively. We hypothesised that posterior approach would be superior to lateral approach. Forty-seven patients with primary hip osteoarthritis were randomised to total hip arthroplasty with either posterior or lateral approach and evaluated pre-operatively, 3 and 12months post-operatively using 3-dimensional gait analyses as objective measures of gait function, including Gait Deviation Index, temporo-spatial parameters and range of motion. Isometric maximal hip muscle strength in abduction, flexion and extension was also tested. Post-operatively, no between-group difference in gait function was observed. However, both hip abductor and flexor muscle strength improved more in the posterior approach group: -0.20(Nm/kg)[95%CI:-0.4 to 0.0] and -0.20(Nm/kg)[95%CI:-0.4 to 0.0], respectively. Contrary to our first hypothesis, the overall gait function in the posterior approach group did not improve more than in the lateral approach group. However, in agreement with our second hypothesis, patients in the posterior approach group improved more in hip abductor and flexor muscle strength at 12months. Further investigation of the effect of reduced maximal hip muscle strength on functional capacity is needed. ClinicalTrials.gov. No.: NCT01616667. Copyright © 2016 Elsevier Ltd. All rights reserved.

Thermal ablation of intrahepatic cholangiocarcinoma: Safety, efficacy, and factors affecting local tumor progression.

PubMed

Takahashi, Edwin A; Kinsman, Kristin A; Schmit, Grant D; Atwell, Thomas D; Schmitz, John J; Welch, Brian T; Callstrom, Matthew R; Geske, Jennifer R; Kurup, A Nicholas

2018-06-04

To evaluate the safety and oncologic efficacy of percutaneous thermal ablation of intrahepatic cholangiocarcinoma (ICC) and identify risk factors for local tumor progression (LTP). Retrospective review of an institutional tumor ablation registry demonstrated that 20 patients (9 males, 11 females; mean age 62.5 ± 15.8 years) with 50 ICCs (mean size 1.8 ± 1.3 cm) were treated with percutaneous radiofrequency ablation (RFA) or microwave ablation (MWA) between 2006 and 2015. Thirty-eight of the treated ICCs (76%) were metastases that developed after surgical resection of the primary tumor. Patient demographics, procedure technical parameters, and clinical outcomes were reviewed. A Cox proportional hazards model was used to examine the risk of LTP by ablation modality. Survival analyses were performed using the Kaplan-Meier method. Mean imaging follow-up time was 41.5 ± 42.7 months. Forty-four (88%) ICCs were treated with RFA, and 6 (12%) with MWA. Eleven (22%) cases of LTP developed in 5 (25%) patients. The median time to LTP among these 11 tumors was 7.1 months (range, 2.3-22.9 months). Risk of LTP was not significantly different for ICCs treated with MWA compared to RFA (HR 2.72; 95% CI 0.58-12.84; p = 03.21). Median disease-free survival was 8.2 months (1.1-70.4 months), and median overall survival was 23.6 months (7.4-122.5 months). No major complication occurred. Percutaneous thermal ablation is a safe and effective treatment for patients with ICCs and may be particularly valuable in unresectable patients, or those who have already undergone hepatic surgery. Tumor size and ablation modality were not associated with LTP, whereas primary tumors and superficially located tumors were more likely to subsequently recur.

A post hoc evaluation of a sample size re-estimation in the Secondary Prevention of Small Subcortical Strokes study.

PubMed

McClure, Leslie A; Szychowski, Jeff M; Benavente, Oscar; Hart, Robert G; Coffey, Christopher S

2016-10-01

The use of adaptive designs has been increasing in randomized clinical trials. Sample size re-estimation is a type of adaptation in which nuisance parameters are estimated at an interim point in the trial and the sample size re-computed based on these estimates. The Secondary Prevention of Small Subcortical Strokes study was a randomized clinical trial assessing the impact of single- versus dual-antiplatelet therapy and control of systolic blood pressure to a higher (130-149 mmHg) versus lower (<130 mmHg) target on recurrent stroke risk in a two-by-two factorial design. A sample size re-estimation was performed during the Secondary Prevention of Small Subcortical Strokes study resulting in an increase from the planned sample size of 2500-3020, and we sought to determine the impact of the sample size re-estimation on the study results. We assessed the results of the primary efficacy and safety analyses with the full 3020 patients and compared them to the results that would have been observed had randomization ended with 2500 patients. The primary efficacy outcome considered was recurrent stroke, and the primary safety outcomes were major bleeds and death. We computed incidence rates for the efficacy and safety outcomes and used Cox proportional hazards models to examine the hazard ratios for each of the two treatment interventions (i.e. the antiplatelet and blood pressure interventions). In the antiplatelet intervention, the hazard ratio was not materially modified by increasing the sample size, nor did the conclusions regarding the efficacy of mono versus dual-therapy change: there was no difference in the effect of dual- versus monotherapy on the risk of recurrent stroke hazard ratios (n = 3020 HR (95% confidence interval): 0.92 (0.72, 1.2), p = 0.48; n = 2500 HR (95% confidence interval): 1.0 (0.78, 1.3), p = 0.85). With respect to the blood pressure intervention, increasing the sample size resulted in less certainty in the results, as the hazard ratio for higher versus lower systolic blood pressure target approached, but did not achieve, statistical significance with the larger sample (n = 3020 HR (95% confidence interval): 0.81 (0.63, 1.0), p = 0.089; n = 2500 HR (95% confidence interval): 0.89 (0.68, 1.17), p = 0.40). The results from the safety analyses were similar to 3020 and 2500 patients for both study interventions. Other trial-related factors, such as contracts, finances, and study management, were impacted as well. Adaptive designs can have benefits in randomized clinical trials, but do not always result in significant findings. The impact of adaptive designs should be measured in terms of both trial results, as well as practical issues related to trial management. More post hoc analyses of study adaptations will lead to better understanding of the balance between the benefits and the costs. © The Author(s) 2016.

Seizure Control in a Computational Model Using a Reinforcement Learning Stimulation Paradigm.

PubMed

Nagaraj, Vivek; Lamperski, Andrew; Netoff, Theoden I

2017-11-01

Neuromodulation technologies such as vagus nerve stimulation and deep brain stimulation, have shown some efficacy in controlling seizures in medically intractable patients. However, inherent patient-to-patient variability of seizure disorders leads to a wide range of therapeutic efficacy. A patient specific approach to determining stimulation parameters may lead to increased therapeutic efficacy while minimizing stimulation energy and side effects. This paper presents a reinforcement learning algorithm that optimizes stimulation frequency for controlling seizures with minimum stimulation energy. We apply our method to a computational model called the epileptor. The epileptor model simulates inter-ictal and ictal local field potential data. In order to apply reinforcement learning to the Epileptor, we introduce a specialized reward function and state-space discretization. With the reward function and discretization fixed, we test the effectiveness of the temporal difference reinforcement learning algorithm (TD(0)). For periodic pulsatile stimulation, we derive a relation that describes, for any stimulation frequency, the minimal pulse amplitude required to suppress seizures. The TD(0) algorithm is able to identify parameters that control seizures quickly. Additionally, our results show that the TD(0) algorithm refines the stimulation frequency to minimize stimulation energy thereby converging to optimal parameters reliably. An advantage of the TD(0) algorithm is that it is adaptive so that the parameters necessary to control the seizures can change over time. We show that the algorithm can converge on the optimal solution in simulation with slow and fast inter-seizure intervals.

Pragmatic, Randomized Controlled Trials of the Girls on the Go! Program to Improve Self-Esteem in Girls.

PubMed

Tirlea, Loredana; Truby, Helen; Haines, Terry P

2016-03-01

To test the effectiveness of an intervention delivered by health professionals outside the school environment to girls identified with issues such as poor body image, low self-esteem, low self-confidence, nonparticipation in sports, or being overweight or underweight. The study's design was a stepped-wedge randomized controlled trial to test the efficacy of an intervention on self-esteem, impairment induced by eating disorders, self-efficacy, body satisfaction, and dieting behaviors. The study took place at the community health center located in a culturally diverse area of Melbourne, Victoria, Australia. Participants were 122 primary and secondary school girls between 10 and 16 years of age. Girls on the Go! is a 10-week program designed to improve self-esteem, body image, and confidence, using an empowerment model that involved interactive and experiential learning approaches. Weekly themes included body image and self-esteem, safety and assertiveness, a healthy mind, physical activity, healthy eating, trust and confidence, and connections. Measurements were made using Rosenberg Self-Esteem Scale, clinical interview assessment, health self-efficacy (included mental health and physical health self-efficacy scales), body esteem scale, and the Dutch Eating Behavior Questionnaire for Children. A linear mixed model was used. The intervention led to a significant increase (p < .05) in self-esteem and self-efficacy (mental and physical health self-efficacy subscales), for both primary and secondary school-aged participants and reduced dieting behaviors (secondary school participants). These gains were retained after 6 months of follow-up. This group-based, low-dose intervention, which, although targeting girls with a range of psychological issues and including both overweight and underweight participants, is a successful means of improving self-esteem among girls from diverse cultural backgrounds. © The Author(s) 2016.

Introduction of a closed-system cell processor for red blood cell washing: postimplementation monitoring of safety and efficacy.

PubMed

Acker, Jason P; Hansen, Adele L; Yi, Qi-Long; Sondi, Nayana; Cserti-Gazdewich, Christine; Pendergrast, Jacob; Hannach, Barbara

2016-01-01

After introduction of a closed-system cell processor, the effect of this product change on safety, efficacy, and utilization of washed red blood cells (RBCs) was assessed. This study was a pre-/postimplementation observational study. Efficacy data were collected from sequentially transfused washed RBCs received as prophylactic therapy by β-thalassemia patients during a 3-month period before and after implementation of the Haemonetics ACP 215 closed-system processor. Before implementation, an open system (TerumoBCT COBE 2991) was used to wash RBCs. The primary endpoint for efficacy was a change in hemoglobin (Hb) concentration corrected for the duration between transfusions. The primary endpoint for safety was the frequency of adverse transfusion reactions (ATRs) in all washed RBCs provided by Canadian Blood Services to the transfusion service for 12 months before and after implementation. Data were analyzed from more than 300 RBCs transfused to 31 recipients before implementation and 29 recipients after implementation. The number of units transfused per episode reduced significantly after implementation, from a mean of 3.5 units to a mean of 3.1 units (p < 0.005). The corrected change in Hb concentration was not significantly different before and after implementation. ATRs occurred in 0.15% of transfusions both before and after implementation. Safety and efficacy of washed RBCs were not affected after introduction of a closed-system cell processor. The ACP 215 allowed for an extended expiry time, improving inventory management and overall utilization of washed RBCs. Transfusion of fewer RBCs per episode reduced exposure of recipients to allogeneic blood products while maintaining efficacy. © 2015 AABB.