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Sample records for prospective efficacy evaluation

  1. A prospective study to evaluate the efficacy of isopropyl alcohol irrigations to prevent cerumen impaction.

    PubMed

    Silverstein, Herbert; Wycherly, Benjamin J; Alameda, Yadiel; Van Ess, Mark J

    2012-03-01

    We conducted a prospective crossover study to assess the safety and efficacy of 70% isopropyl alcohol delivered from a squeezable bottle with a specially designed tip as a weekly irrigant to reduce cerumen accumulation. Twenty patients were divided into 2 groups of 10 (20 ears in each group). The patients in group 1 instilled 70% isopropyl alcohol once a week for 2 months; this was followed by 2 months of no ear cleaning. The patients in group 2 performed the opposite routine. At each visit (0, 2, and 4 mo), cerumen accumulation was graded on a scale of 0 to 4, indicating 0, 25, 50, 75, and 100% occlusion, respectively. After the accumulation was graded, a cerumenectomy was performed. At the initial evaluation, the mean occlusion scores were 3.1 for group 1 and 3.3 for group 2-not a statistically significant difference. After the first 2 months of the study, there was a significant difference in occlusion scores between groups 1 and 2 (0.75 and 1.55, respectively; p < 0.0002). At 4 months, after the crossover, the occlusion scores were 1.15 and 0.95, respectively, not a significant difference (p = 0.38). At study's end, there were also significant differences within each group between occlusion scores obtained during the treatment and nontreatment periods (group 1: p < 0.02; group 2: p < 0.01). All patients tolerated the alcohol rinse well, and there were no cases of external otitis or other complications. We conclude that weekly irrigation with 70% isopropyl alcohol is safe and reduces the accumulation of cerumen in the external auditory canal. Routine use should decrease the number of office visits for cerumen removal and hearing aid cleaning.

  2. METODO, a prospective observational study to assess the efficacy and tolerability of methadone in heroin-addicted patients undergoing a methadone maintenance treatment: preliminary results at baseline evaluation.

    PubMed

    D'Egidio, Pietro Fausto; Bignamini, Emanuele; De Vivo, Enrico; Leonardi, Claudio; Pieri, Maria Chiara; González-Saiz, Francisco; Lucchini, Alfio

    2013-12-01

    METODO (methadone efficacy therapy optimization dosage on-going) is a prospective observational study to assess the efficacy and tolerability of methadone in 500 heroin-addicted patients taking a methadone maintenance treatment, enrolled through 2010 to 2011 in five Italian sites, observed over 2 years. The Opiate Dosage Adequacy Scale has been used for the evaluation of the "adequacy" of the methadone dosage and to stratify patients in adequate and not adequate groups. The treatment efficacy has been evaluated in correlation to the dosage adequacy during the visits. Moreover, patients have been evaluated according to the retention rate and duration of retention in treatment and a series of questionnaires.

  3. Prospective study to evaluate safety and efficacy of Zotarolimus Eluting Stent (PSEZES) in patients with long coronary artery lesions

    PubMed Central

    Bahuleyan, C.G.; Krishna Kumar, V.V.; Babu, Shifas

    2015-01-01

    Background Although the safety and effectiveness of Drug-Eluting Stents (DES) has been established extensively, reports on long term clinical outcome with angiographic findings in patients with long coronary artery lesions are not many. Methods In this single-center prospective registry of 100 patients, a total of 110 denovo long lesions (>20 mm) were treated with Resolute Zotarolimus Eluting Stent (R-ZES). The patients were followed up clinically at 3, 6 and 12 months and follow up coronary angiography was performed at 9-months. The primary end point was one year rate of target lesion failure (TLF) which is a composite of cardiac death, target lesion myocardial infarction or ischemia driven target lesion revascularization (TLR). The secondary end points included definite or probable stent thrombosis, 9-month angiographic restenosis and late lumen loss. Results The mean age of patients was 58.7 ± 9.50 years with prevalence of diabetes as high as 60%. The mean lesion length was 24.67 ± 4.87 mm with a mean reference vessel diameter of 2.85 ± 0.32 mm and 67.3% were Type C lesions (ACC/AHA classification). Two patients died during follow-up, of which one was non-cardiac death. One patient had target vessel myocardial infarction and five patients (4.5%) had ischemia driven TLR. The incidence of TLF was 6.36%. Binary restenosis was seen in 7 out of 93 lesions (7.5%). Median late lumen loss at 9 month was 0.22 mm. No stent thrombosis was noted in the study. Conclusion Implantation of R-ZES in real-world patients with long coronary artery lesions is safe with comparable efficacy to what is observed in the treatment of less complex lesions. PMID:26138180

  4. Comparative Evaluation of Efficacy of Physics Forceps versus Conventional Forceps in Orthodontic Extractions: A Prospective Randomized Split Mouth Study

    PubMed Central

    Managutti, Anil M; Menat, Shailesh; Agarwal, Arvind; Shah, Dishan; Patel, Jigar

    2016-01-01

    Introduction Tooth extraction is one of the most commonly performed procedures in dentistry. It is usually a traumatic procedure often resulting in immediate destruction and loss of alveolar bone and surrounding soft tissues. Various instruments have been described to perform atraumatic extractions which can prevent damage to the paradental structures. Recently developed physics forceps is one of the instruments which is claimed to perform atraumatic extractions. Aim The aim of the present study was to compare the efficacy of physics forceps with conventional forceps in terms of operating time, prevention of marginal bone loss & soft tissue loss, postoperative pain and postoperative complications following bilateral premolar extractions for orthodontic purpose. Materials and Methods In this prospective split-mouth study, outcomes of the 2 groups (n = 42 premolars) requiring extraction of premolars for orthodontic treatment purpose using Physics forceps and Conventional forceps were compared. Clinical outcomes in form of time taken, loss of buccal soft tissue and buccal cortical plate based on extraction defect classification system, postoperative pain and other complication associated with extraction were recorded and compared. Results Statistically significant reduction in the operating time was noted in physics forceps group. Marginal bone loss and soft tissue loss was also significantly lesser in physics forceps group when compared to conventional forceps group. However, there was no statistically significant difference in severity of postoperative pain between both groups. Conclusion The results of the present study suggest that physics forceps was more efficient in reducing operating time and prevention of marginal bone loss & soft tissue loss when compared to conventional forceps in orthodontically indicated premolar extractions. PMID:27630951

  5. A prospective comparative field study to evaluate the efficacy of a traditional plant-based malaria prophylaxis

    PubMed Central

    Nagendrappa, Prakash Bangalore; Annamalai, Pradeep; Naik, Muruli; Mahajan, Vinay; Mathur, Ashwini; Susanta, Ghosh; Gay, Frederick; Venkatasubramanian, Padma

    2017-01-01

    Background: An unceasing threat of resistance of malarial parasites to available antimalarial drugs makes the development of new drugs imperative. Natural plant-based products are an alternative source for discovering new antimalarial drugs. Aim: To determine the prophylactic efficacy of a traditionally used plant-based drug on prevention of malaria in endemic villages of Odisha, India. Methods: A total of 267 healthy human volunteers of both sexes, aged 18-60 years were enrolled in Odisha, India, to receive either minimum 20 doses of aqueous extract of Traditional Plant-based Malaria Prophylactic drug 74, twice a week (experimental group), or no drug (control group) for 14 weeks. The primary criterion was the occurrence of malaria positive cases confirmed through expert microscopy during the study period. Analyses were by per-protocol (PP) and modified intention-to-treat (mITT). Results: A significant (P < 0.01) reduction (64%) of malaria incidence was observed in the experimental group compared to control group, 12.3% and 26.6%, respectively, as PP analysis. However, the reduction was nonsignificant as per mITT analysis (P = 0.22). The experimental group showed a relative risk of 0.36 compared to control group. Conclusion: This preliminary study constitutes a potential “proof of concept” for the development of malaria prophylactic drug and provide a scientific basis for the use of traditional remedy as a malaria preventive by tribal populations in India. PMID:28163958

  6. Prospective Evaluation of Cetuximab-Mediated Antibody-Dependent Cell Cytotoxicity in Metastatic Colorectal Cancer Patients Predicts Treatment Efficacy.

    PubMed

    Trotta, Anna Maria; Ottaiano, Alessandro; Romano, Carmela; Nasti, Guglielmo; Nappi, Anna; De Divitiis, Chiara; Napolitano, Maria; Zanotta, Serena; Casaretti, Rossana; D'Alterio, Crescenzo; Avallone, Antonio; Califano, Daniela; Iaffaioli, Rosario Vincenzo; Scala, Stefania

    2016-04-01

    Cetuximab is a monoclonal antibody to the EGFR that induces antibody-dependent cell cytotoxicity (ADCC) through Fcγ receptors on immune cells. Although SNPs in genes encoding Fcγ receptors are functionally relevant to cetuximab-mediated ADCC in colorectal cancer, a direct correlation between in vitro ADCC and clinical response to cetuximab is not defined. We therefore enrolled 96 consecutive metastatic colorectal cancer (mCRC) patients at diagnosis in a study that assessed FcγR status and cetuximab-mediated ADCC. Patients carrying the FcγRIIa H alleles 131H/Hand 131H/R had significantly higher ADCC compared with patients with the 131R/R alleles (P= 0.013). Patients carrying FcγRIIIa genotypes with the V alleles 158V/V and 158V/F displayed higher ADCC compared with patients carrying the 158F/F genotype (P= 0.001). Progression-free survival of patients with an FcγRIIIa 158V allele was significantly longer compared with patients carrying 158F/F (P= 0.05), whereas no significant difference was observed for overall survival. Twenty-eight of 50 mCRC patients with wild-type KRAS received cetuximab. The average ADCC-mediated killing was 30% of assay targets for patients who experienced cetuximab complete or partial response, 21% in patients with stable disease and 9% in patients with progressive disease. To characterize basal natural killer (NK) activity, cytotoxicity was evaluated in 39 of 96 mCRC patients. Patients who responded to first-line treatment had higher NK-cell cytotoxicity. Thus, although limited to this cohort of patients, in vitro cetuximab-mediated ADCC correlated with FcγR polymorphisms and predicted cetuximab responsiveness.

  7. A prospective study to evaluate the efficacy and safety of oral acetyl-L-carnitine for the treatment of chemotherapy-induced peripheral neuropathy.

    PubMed

    Sun, Yuanjue; Shu, Yongqian; Liu, Baorui; Liu, Ping; Wu, Changping; Zheng, Rongsheng; Zhang, Xiaohua; Zhuang, Zhixiang; Deng, Yongchuan; Zheng, Leizhen; Xu, Qing; Jiang, Bin; Ouyang, Xuenong; Gao, Jianfei; Xu, Nong; Li, Xiaoyi; Jiang, Su; Liang, Chaofan; Yao, Yang

    2016-12-01

    The present study aimed to evaluate the efficacy and safety of acetyl-L-carnitine (ALC) for the treatment of chemotherapy-induced peripheral neuropathy (CIPN). The study was carried out as a prospective, randomized, double-blind, placebo-controlled and paralleled clinical study. A total of 239 patients with CIPN were selected as the study subjects. Of the 239 subjects, 118 subjects received 3 g/day ALC orally for 8 weeks and 121 received a placebo. The primary endpoint was improvement of peripheral neuropathy by at least one grade. Patient status was assessed at week 4, 8 and 12 after enrollment into the study. In both the full analysis set (FAS) and the per-protocol set (PPS), peripheral sensory neuropathy was significantly ameliorated in the ALC group with 50.5 and 51.6% patients meeting the primary endpoint at week 8, compared with 24.1 and 23.1% of patients in the placebo group (P<0.001 in both sets). Secondary endpoints, such as the nerve electrophysiological examination and the Karnofsky physical score were also significantly improved in patients receiving ALC treatment, as compared with the placebo group (FAS, P=0.0463 and P=0.022; PPS, P=0.0076 and P=0.0064, respectively). Cancer-associated fatigue was significantly alleviated following ALC treatment in the PPS (P=0.0135). In the safety analysis set, the difference in adverse events incidence between the two groups was not statistically significant (P=0.3903). There were only two severe adverse events in the ALC group, which were not associated with the effect of ALC. In conclusion, the results of the present study demonstrated that in Chinese patients with cancer, oral administration of ALC is effective at ameliorating peripheral sensory neuropathy induced by chemotherapy, as well as reducing of cancer-associated fatigue and improving physical conditions.

  8. A prospective study to evaluate the efficacy and safety of oral acetyl-L-carnitine for the treatment of chemotherapy-induced peripheral neuropathy

    PubMed Central

    Sun, Yuanjue; Shu, Yongqian; Liu, Baorui; Liu, Ping; Wu, Changping; Zheng, Rongsheng; Zhang, Xiaohua; Zhuang, Zhixiang; Deng, Yongchuan; Zheng, Leizhen; Xu, Qing; Jiang, Bin; Ouyang, Xuenong; Gao, Jianfei; Xu, Nong; Li, Xiaoyi; Jiang, Su; Liang, Chaofan; Yao, Yang

    2016-01-01

    The present study aimed to evaluate the efficacy and safety of acetyl-L-carnitine (ALC) for the treatment of chemotherapy-induced peripheral neuropathy (CIPN). The study was carried out as a prospective, randomized, double-blind, placebo-controlled and paralleled clinical study. A total of 239 patients with CIPN were selected as the study subjects. Of the 239 subjects, 118 subjects received 3 g/day ALC orally for 8 weeks and 121 received a placebo. The primary endpoint was improvement of peripheral neuropathy by at least one grade. Patient status was assessed at week 4, 8 and 12 after enrollment into the study. In both the full analysis set (FAS) and the per-protocol set (PPS), peripheral sensory neuropathy was significantly ameliorated in the ALC group with 50.5 and 51.6% patients meeting the primary endpoint at week 8, compared with 24.1 and 23.1% of patients in the placebo group (P<0.001 in both sets). Secondary endpoints, such as the nerve electrophysiological examination and the Karnofsky physical score were also significantly improved in patients receiving ALC treatment, as compared with the placebo group (FAS, P=0.0463 and P=0.022; PPS, P=0.0076 and P=0.0064, respectively). Cancer-associated fatigue was significantly alleviated following ALC treatment in the PPS (P=0.0135). In the safety analysis set, the difference in adverse events incidence between the two groups was not statistically significant (P=0.3903). There were only two severe adverse events in the ALC group, which were not associated with the effect of ALC. In conclusion, the results of the present study demonstrated that in Chinese patients with cancer, oral administration of ALC is effective at ameliorating peripheral sensory neuropathy induced by chemotherapy, as well as reducing of cancer-associated fatigue and improving physical conditions. PMID:28105133

  9. Evaluation of atorvastatin efficacy and toxicity on spermatozoa, accessory glands and gonadal hormones of healthy men: a pilot prospective clinical trial

    PubMed Central

    2014-01-01

    Background Recommendations for cardiovascular disease prevention advocate lowering both cholesterol and low-density lipoprotein cholesterol systemic levels, notably by statin intake. However, statins are the subject of questions concerning their impact on male fertility. This study aimed to evaluate, by a prospective pilot assay, the efficacy and the toxicity of a decrease of cholesterol blood levels, induced by atorvastatin on semen quality and sexual hormone levels of healthy, normocholesterolaemic and normozoospermic men. Methods Atorvastatin (10 mg daily) was administrated orally during 5 months to 17 men with normal plasma lipid and standard semen parameters. Spermatozoa parameters, accessory gland markers, semen lipid levels and blood levels of gonadal hormones were assayed before statin intake, during the treatment, and 3 months after its withdrawal. Results Atorvastatin treatment significantly decreased circulating low-density lipoprotein cholesterol (LDL-C) and total cholesterol concentrations by 42% and 24% (p < 0.0001) respectively, and reached the efficacy objective of the protocol. During atorvastatin therapy and/or 3 months after its withdrawal numerous semen parameters were significantly modified, such as total number of spermatozoa (-31%, p < 0.05), vitality (-9.5%, p < 0.05), total motility (+7.5%, p < 0.05), morphology (head, neck and midpiece abnormalities, p < 0.05), and the kinetics of acrosome reaction (p < 0.05). Seminal concentrations of acid phosphatases (p < 0.01), α-glucosidase (p < 0.05) and L-carnitine (p < 0.05) were also decreased during the therapy, indicating an alteration of prostatic and epididymal functions. Moreover, we measured at least one altered semen parameter in 35% of the subjects during atorvastatin treatment, and in 65% of the subjects after withdrawal, which led us to consider that atorvastatin is unsafe in the context of our study. Conclusions Our results show for the first

  10. A prospective, open-label, single arm, multicentre study to evaluate efficacy, safety and acceptability of pericoital oral contraception using levonorgestrel 1.5 mg

    PubMed Central

    Festin, Mario P.R.; Bahamondes, Luis; Nguyen, Thi My Huong; Habib, Ndema; Thamkhantho, Manopchai; Singh, Kuldip; Gosavi, Arundhati; Bartfai, Gyorgy; Bito, Tamas; Bahamondes, M. Valeria; Kapp, Nathalie

    2016-01-01

    STUDY QUESTION Will the use of levonorgestrel (LNG) 1.5 mg taken at each day of coitus by women who have relatively infrequent sex be an efficacious, safe and acceptable contraceptive method? SUMMARY ANSWER Typical use of LNG 1.5 mg taken pericoitally, before or within 24 h of sexual intercourse, provides contraceptive efficacy of up to 11.0 pregnancies per 100 women-years (W-Y) in the primary evaluable population and 7.1 pregnancies per 100 W-Y in the evaluable population. WHAT IS KNOWN ALREADY LNG 1.5 mg is an effective emergency contraception following unprotected intercourse. Some users take it repeatedly, as their means of regular contraception. STUDY DESIGN, SIZE, DURATION This was a prospective, open-label, single-arm, multicentre Phase III trial study with women who have infrequent coitus (on up to 6 days a month). Each woman had a follow-up visit at 2.5, 4.5 and 6.5 months after admission or until pregnancy occurs if sooner, or she decided to interrupt participation. The study was conducted between 10 January 2012 and 15 November 2014. PARTICIPANTS/MATERIALS, SETTING, METHODS A total of 330 healthy fertile women aged 18–45 years at risk of pregnancy who reported sexual intercourse on up to 6 days a month, were recruited from four university centres located in Bangkok, Thailand; Campinas, Brazil; Singapore and Szeged, Hungary to use LNG 1.5 mg pericoitally (24 h before or after coitus) as their primary method of contraception. The participants were instructed to take one tablet every day she had sex, without taking more than one tablet in any 24-h period, and to maintain a paper diary for recording date and time for every coital act and ingestion of the study tablet, use of other contraceptive methods and vaginal bleeding patterns. Anaemia was assessed by haemoglobin evaluation. Pregnancy tests were performed monthly and pregnancies occurring during product use were assessed by ultrasound. At the 2.5-month and final visit at 6.5 months, acceptability

  11. Academic Self-Efficacy and Prospective ELT Teachers' Achievement

    ERIC Educational Resources Information Center

    Sariçoban, Arif; Behjoo, Bahram Mohammadi

    2016-01-01

    This study aims to scrutinize the possible relationship between academic self-efficacy beliefs and foreign language achievement among prospective ELT teachers. To do so, the data for the study were collected through a questionnaire, "College Academic Self-Efficacy Scale" adapted from Owen & Froman (1988), consisting of 33 items…

  12. Evaluation of the safety and efficacy of recombinant soluble thrombomodulin for patients with disseminated intravascular coagulation associated with acute leukemia: multicenter prospective study by the Tohoku Hematology Forum.

    PubMed

    Yokoyama, Hisayuki; Takahashi, Naoto; Katsuoka, Yuna; Inomata, Mitsue; Ito, Toshihiro; Meguro, Kuniaki; Kameoka, Yoshihiro; Tsumanuma, Riko; Murai, Kazunori; Noji, Hideyoshi; Ishizawa, Kenichi; Ito, Shigeki; Onishi, Yasushi; Harigae, Hideo

    2017-02-07

    It has been suggested that use of recombinant soluble thrombomodulin (rTM) is superior to conventional drugs in treatment of disseminated intravascular coagulation (DIC) complicating acute leukemia. However, its safety and efficacy have not been fully examined in prospective studies. Here, we performed a multicenter prospective study to examine outcomes of rTM treatment for DIC in patients with acute leukemia. Of 33 patients registered in this study, 13 had acute myeloid leukemia (AML), three had acute lymphoblastic leukemia (ALL), and 17 had acute promyelocytic leukemia (APL). The cumulative rates of DIC resolution at day 7 and day 35 were 56 and 81% in AML/ALL and 53 and 77% in APL, respectively. The median time from the initiation of rTM to DIC resolution was 4 days in AML/ALL and 6 days in APL patients. Adverse events related to hemorrhage occurred in two AML/ALL patients (13%) and three APL patients (18%). Of these, one AML/ALL patient died with intracranial hemorrhage, and two APL patients died with intracranial hemorrhage and pulmonary hemorrhage. These results suggest that rTM may improve the survival of acute leukemia patients with DIC by inhibiting early death related to hemorrhagic events, as reported previously.

  13. A Prospective, Multicentre, Open-Label Single-Arm Exploratory Study to Evaluate Efficacy and Safety of Saroglitazar on Hypertriglyceridemia in HIV Associated Lipodystrophy

    PubMed Central

    Joshi, Shashank

    2016-01-01

    Objective This study was designed to explore the efficacy and safety of saroglitazar 4 mg on hypertriglyceridemia in patients with HIV associated lipodystrophy. Methods During this 12-week prospective, multi-centric, open-label, single arm exploratory study, 50 patients were enrolled to receive saroglitazar 4 mg orally once daily in the morning before breakfast. The primary efficacy endpoint was the percent change in triglyceride (TG) levels from baseline to Week 6 and Week 12. The secondary efficacy endpoints were assessment of low-density-lipoprotein (LDL), very-low-density-lipoprotein (VLDL), high-density-lipoprotein (HDL), non-HDL cholesterol, total cholesterol, apo-lipoprotein (Apo) A1, Apo B, and C-peptide and fasting insulin for HOMA beta and HOMA IR. Safety assessment was performed during the study. Results Saroglitazar 4 mg significantly decreased the serum TG levels from baseline at Week 6 (percent change: -40.98; 95% CI: -50.82, -31.15) and Week 12 (percent change -45.11; 95% CI: -52.37, -37.86). Reduction in VLDL cholesterol (percent change: -46.33; 95% CI: -52.89, -39.76) and total cholesterol (percent change: 7.37; 95% CI: 1.96, 12.78) was observed at week 12 from baseline. Saroglitazar increased HDL cholesterol (percent change: 34.56, 95% CI: 22.22, 46.90), Apo A1 (percent change: 33.16; 95% CI: 18.69, 47.63) and Apo B (percent change: 10.55, 95% CI: 2.86, 18.25) levels at week 12 from baseline. Saroglitazar treatment led to increase in the C-peptide (percent change: 59.42, 95% CI: 48.78, 70.06), fasting insulin levels (percent change: 47.10; 95% CI: 38.63, 55.57), HOMA of beta cell function for C-peptide (percent change: 71.67; 95% CI: 39.09, 104.26) and HOMA of insulin resistance for C-peptide (percent change: 58.29, 95% CI: 46.74, 69.83) at week 12 from baseline. Saroglitazar treatment was safe and well tolerated in this study. Conclusion Overall, the observed changes in lipid profile after 12 weeks of saroglitazar treatment were in the direction

  14. [The preclinical efficacy of emergency care. A prospective study].

    PubMed

    Hennes, H J; Reinhardt, T; Otto, S; Dick, W

    1993-07-01

    Quality assurance has become an important issue in emergency medicine. At present, no prospective studies are available that quantify the efficacy of interventions performed by emergency doctors. The development and implementation of a rapid, yet simple scoring system, allowing preclinical assessment of all emergency medicine patients, is required. Once the scoring system is implemented, evaluation of the prehospital intervention, based upon objective parameters, is possible. METHODS. The Mainz Emergency Evaluation Score (MEES) is based on seven parameters: level of consciousness, heart rate, heart rhythm, arterial blood pressure, respiratory rate, partial arterial oxygen saturation and pain. A coded value is assigned to each parameter, with the normal physiological condition securing a score of 4, while a life-threatening condition receives a value of 1. For the parameter of pain there is no life-threatening condition, so the lowest value allowed is 2 (Table 2). Addition of the respective values from the seven parameters yields the MEES value, which objectively reflects the patients' condition (minimum = 8, maximum = 28). Comparing the MEES value before (MEES1) and after the intervention (MEES2) allows an objective evaluation of the efficacy of the preclinical care (delta-MEES = MEES2-MEES1). A difference of > or = +2 is considered an improvement, +1, +/- 0, -1 are rated as unchanged and < or = -2 is considered a deterioration in the patients condition. For more detailed evaluation the patients were allocated to 16 diagnosis groups (Table 3). Statistical evaluation utilized analysis of variance, the rank sum test (Wilcoxon) and the correlation coefficient (Kendall-Tau). RESULTS. In 356 patients the condition of 187 (52%) patients improved during the preclinical treatment; the condition of 156 (44%) patients did not change. In 13 patients (3%) the condition became worse (Table 5, Fig. 2). Allocation to 16 diagnosis groups revealed that the improvement in the

  15. “The ABCs of AD”: A prospective evaluation of the efficacy of an educational intervention to increase knowledge of autonomic dysreflexia management among emergency health care professionals

    PubMed Central

    Krassioukov, Andrei; Tomasone, Jennifer R.; Pak, Melissa; Craven, B. Catharine; Ghotbi, Mohammad H.; Ethans, Karen; Martin Ginis, Kathleen A.; Ford, Michael; Krassioukov-Enns, Dmitri

    2016-01-01

    Context/Objective Despite the availability of consensus-based resources, first responders and emergency room (ER) health care professionals (HCPs) have limited knowledge regarding autonomic dysreflexia (AD) recognition and treatment. The purpose of this study was to assess the efficacy of “The ABCs of AD” educational seminar for improving HCPs’ short- and long-term knowledge of AD recognition, diagnosis, and management. Design Multi-center prospective pre, post, and follow-up questionnaire study. Setting Level I trauma centers with emergency departments in British Columbia, Manitoba, and Ontario. Methods ER professionals completed measures immediately before and after (n = 108), as well as 3-months following (n = 23), attendance at “The ABCs of AD” seminar. Outcome Measures AD knowledge test; seminar feedback. Results Following the seminar, participants had higher ratings of their AD knowledge and had significantly higher AD knowledge test scores (M ± SD pre = 11.85 ± 3.88, M ± SD post = 18.95 ± 2.39, out of 22; P < 0.001, d = 2.21). Most participants believed the seminar changed their AD knowledge, and rated the seminar information as having the potential to influence and change their practice. AD knowledge test scores significantly decreased between post-seminar and 3-month follow-up (M ± SD 3mo = 17.04 ± 3.28; P = 0.004, d = –0.70); however, 3-month scores remained significantly higher than baseline. Conclusion “The ABCs of AD” seminar improves HCPs’ perceived and actual AD knowledge in the short-term. To enhance knowledge retention in both the short- and long-term, the inclusion of additional active learning strategies and follow-up activities are recommended. The seminar is being translated into an online training module to enhance the dissemination of the AD clinical practice guidelines among first responders, ER staff, and SCI practitioners. PMID:26108353

  16. Prospective multi-center registry to evaluate efficacy and safety of the newly developed diamond-like carbon-coated cobalt-chromium coronary stent system.

    PubMed

    Ando, Kenji; Ishii, Katsuhisa; Tada, Eiji; Kataoka, Kazuaki; Hirohata, Atsushi; Goto, Kenji; Kobayashi, Katsuyuki; Tsutsui, Hiroshi; Nakahama, Makoto; Nakashima, Hitoshi; Uchikawa, Shinichiroh; Kanda, Junji; Yasuda, Satoshi; Yajima, Junji; Kitabayashi, Hiroshi; Sakurai, Shumpei; Nakanishi, Keita; Inoue, Naoto; Noike, Hirofumi; Hasebe, Terumitsu; Sato, Tetsuya; Yamasaki, Masao; Kimura, Takeshi

    2016-07-22

    The purpose of this multi-center, non-randomized, and open-label clinical trial was to determine the non-inferiority of diamond-like carbon (DLC)-coated cobalt-chromium coronary stent, the MOMO DLC coronary stent, relative to commercially available bare-metal stents (MULTI-LINK VISION(®)). Nineteen centers in Japan participated. The study cohort consisted of 99 patients from 19 Japanese centers with single or double native coronary vessel disease with de novo and restenosis lesions who met the study eligibility criteria. This cohort formed the safety analysis set. The efficacy analysis set consisted of 98 patients (one case was excluded for violating the eligibility criteria). The primary endpoint was target vessel failure (TVF) rate at 9 months after stent placement. Of the 98 efficacy analysis set patients, TVF occurred in 11 patients (11.2 %, 95 % confidence interval 5.7-19.2 %) at 9 months after the index stent implantation. The upper 95 % confidence interval for TVF of the study stent was lower than that previously reported for the commercially available MULTI-LINK VISION(®) (19.6 %), demonstrating non-inferiority of the study stent to MULTI-LINK VISION(®). All the TVF cases were related to target vascular revascularization. None of the cases developed in-stent thrombosis or myocardial infarction. The average in-stent late loss and binary restenosis rate at the 6-month follow-up angiography were 0.69 mm and 10.5 %, respectively, which are lower than the reported values for commercially available bare-metal stents. In conclusion, the current pivotal clinical study evaluating the new MOMO DLC-coated coronary stent suggested its low rates of TVF and angiographic binary restenosis, and small in-stent late loss, although the data were considered preliminary considering the small sample size and single arm study design.

  17. In vitro safety and efficacy evaluations of a complex botanical mixture of Eugenia dysenterica DC. (Myrtaceae): Prospects for developing a new dermocosmetic product.

    PubMed

    Moreira, Larissa Cleres; de Ávila, Renato Ivan; Veloso, Danillo Fabrini Maciel Costa; Pedrosa, Tatiana Nascimento; Lima, Emerson Silva; do Couto, Renê Oliveira; Lima, Eliana Martins; Batista, Aline Carvalho; de Paula, José Realino; Valadares, Marize Campos

    2017-04-04

    In the context of developing a new natural product-based cosmetic, the in vitro efficacy and safety evaluations of a complex botanical mixture based on Eugenia dysenterica leaf hydroalcoholic extract (EDE) (2.5-1000μg/mL) were carried out. Chromatographic analysis demonstrated the presence of the tannin (ellagic acid) and flavonoids (quercetin and gallic acid) which characterize the EDE as a polyphenol-rich mixture. Using HFF-1 fibroblasts, it was shown that EDE promoted cell regeneration after UVA exposure. It also led to the inhibition of the collagenase, elastase and tyrosinase enzymes, which are involved in skin-related disorders. In terms of toxicological evaluation, the EDE was classified as non-phototoxic through the 3T3 Neutral Red Uptake Phototoxicity Test (OECD N° 432, 2004) and non-eye irritant by Bovine Corneal Opacity and Permeability (OECD N° 437, 2013) assay, in conjunction with corneal histomorphometric analysis. Furthermore, the EDE has no skin sensitization potential as demonstrated by a two-out-of-three prediction model [protein-binding/haptenization (OECD N° 442C, 2015), keratinocyte and dendritic cell activations]. In addition, it was shown that the EDE seems to be non-genotoxic through the cytokinesis-block micronucleus assay (OECD N° 487, 2014) using HepG2 cells. When considered together, these findings support the use of EDE botanical mixture in cosmetic/pharmaceutical products.

  18. A prospective multicentre study to evaluate the efficacy and tolerability of osmotic release oral system (OROS®) hydromorphone in opioid-naive cancer patients: Results of the Korean South West Oncology Group study

    PubMed Central

    Song, Eun-Kee; Shim, Hyunjeong; Han, Hye-Suk; Sun, DerSheng; Lee, Soon-Il; Kang, Myung Hee; Lee, KyuTaek; Cho, DoYeun; Cho, In Sung; Park, Suk Young; Kim, Samyong; Yim, Chang-Yeol

    2015-01-01

    BACKGROUND: Osmotic release oral system (OROS®) hydromorphone is a potent, long-acting opioid analgesic, effective and safe for controlling cancer pain in patients who have received other strong opioids. To date, few studies have examined the efficacy of hydromorphone for pain relief in opioid-naive cancer patients. OBJECTIVES: A prospective, open-label, multicentre trial was conducted to determine the efficacy and tolerability of OROS hydromorphone as a single and front-line opioid therapy for patients experiencing moderate to severe cancer pain. METHODS: OROS hydromorphone was administered to patients who had not previously received strong, long-acting opioids. The baseline evaluation (visit 1) was followed by two evaluations (visits 2 and 3) performed two and 14 weeks later, respectively. The starting dose of OROS hydromorphone was 4 mg/day and was increased every two days when pain control was insufficient. Immediate-release hydromorphone was the only accepted alternative strong opioid for relief of breakthrough pain. The efficacy, safety and tolerability of OROS hydromorphone, including the effects on quality of life, and patients’ and investigators’ global impressions on pain relief were evaluated. The primary end point was pain intensity difference (PID) at visit 2 relative to visit 1 (expressed as %PID). RESULTS: A total of 107 patients were enrolled in the present study. An improvement in pain intensity of >50% (≥50% PID) was observed in 51.0% of the full analysis set and 58.6% of the per-protocol set. The mean pain score, measured using a numerical rating scale, was significantly reduced after two weeks of treatment, and most adverse events were manageable. Quality of life also improved, and >70% of patients and investigators were satisfied with the treatment. CONCLUSIONS: OROS hydromorphone provided effective pain relief and improved quality of life in opioid-naive cancer patients. As a single and front-line treatment, OROS hydromorphone delivered

  19. Pre-release efficacy test of the prospective biological control agent Arytinnis hakani on the invasive weed Genista monspessulana

    Technology Transfer Automated Retrieval System (TEKTRAN)

    In weed biological control, conducting a pre-release efficacy test can help ascertain if prospective biological control agents will be capable of controlling the target plant. Currently, the phloem-feeding psyllid, Arytinnis hakani, is being evaluated as a prospective agent for the exotic invasive w...

  20. Evaluation of efficacy of amikacin for attenuation of catheter-related bladder discomfort in patients undergoing percutaneous nephrolithotomy: A prospective, randomized, placebo-controlled, double-blind study

    PubMed Central

    Verma, Ruchi; Agarwal, Anil; Singh, Prabhat Kumar; Gupta, Devendra; Shamim, Rafat

    2016-01-01

    Context: Catheter-related bladder discomfort (CRBD) is the most distressing symptom in patients due to intraoperative urinary catheterization. Amikacin significantly inhibits detrusor contraction evoked by prejunctional stimulation. Aims: The aim of this study is to evaluate the efficacy of amikacin in prevention of CRBD in patients undergoing percutaneous nephrolithotomy. Settings and Design: Study areas were operation theater and postanesthesia care unit of the Department of Anesthesiology, SGPGIMS, Lucknow. Subjects and Methods: One hundred adult patients of either sex were randomly assigned into two groups of fifty each. Patients in control group received normal saline whereas patients in amikacin group received amikacin 10 mg/kg just before induction. Grading of CRBD was done as none, mild, moderate, and severe by a blinded observer at 0, 1, 6, 12, and 24 h after surgery. Statistical Analysis Used: Data were analyzed using Student's t-test and Chi-square test among groups. Incidence of CRBD was compared with Chi-square test whereas severity was analyzed by the test of proportions (Z-test). Visual analog score was compared using Mann–Whitney U-test for surgical site pain. Results: Incidence of CRBD in control group was 66% as compared to 44% observed in amikacin group (P < 0.05). During intergroup comparison at different time points, incidence of CRBD was reduced at 1 and 6 h in the amikacin group (P < 0.05). Significant reduction in the severity of CRBD (moderate) was also observed at 1 h in the amikacin group (P < 0.05). At rest of the time points, there was no significant difference. Conclusions: Amikacin can significantly reduce the incidence and severity of CRBD in the first few hours after surgery. PMID:27746561

  1. Evaluation of the Analgesic Efficacy of Melatonin in Patients Undergoing Cesarean Section Under S pinal Anesthesia: A Prospective Randomized Double-blind Study

    PubMed Central

    Beigom Khezri, Marzieh; Delkhosh Reihany, Morteza; Oveisy, Sonia; Mohammadi, Navid

    2016-01-01

    Melatonin has been suggested as a new natural pain killer in inflammatory pain and during surgical procedures. We designed this randomized double-blind controlled study to evaluate the analgesic efficacy and also optimal preemptive dose of melatonin in patients undergoing cesarean section under spinal anesthesia . One hundred twenty patients scheduled for cesarean section under spinal anesthesia were randomly allocated to one of three groups of 40 each to receive melatonin 3 milligram (mg) (group M3), melatonin 6 mg (group M6) or placebo (group P) sublingually 20 min before the spinal anesthesia. The time to first analgesic request, analgesic requirement in the first 24 h after surgery, hemodynamic variables, anxiety scores nd the incidence of adverse events were recorded. The duration of anesthesia and analgesia didn’t show significant differences between three groups. Total analgesic request during 24 h after surgery was different among the three groups (P = 0.035). The incidence of headache in group M6 was significantly higher than others (P<0.001). However, after adjusting headache between groups of the study, we were unable to show the significant difference in the total analgesic request during 24 h after surgery among the three groups (p = 0.058). Although premedication of patients with 3 mg sublingual melatonin prolonged time to first analgesic request after cesarean delivery compared to placebo group, the difference was not statistically significant. Meanwhile increasing dose of melatonin to 6 mg failed to enhance analgesia and also increase the incidence of headache in patients undergoing cesarean section under spinal anesthesia. PMID:28243296

  2. Prospective Evaluation of Ventriculostomy Infections

    PubMed Central

    Worley, Emmagene; Astle, Sonia

    2015-01-01

    Introduction: Hospital-acquired infections associated with external drainage of ventricular cerebrospinal fluid (CSF) are a significant source of concern for the patients and the provider team alike. Traditional rates of ventriculostomy infection range from 10-17% in a time-dependent fashion. Changing physician and nursing practices fueled this concern over infections.  Objective: We sought to prospectively identify the risk factors associated with ventriculostomy infections as part of a quality assurance project.  Methods: One hundred consecutive patients were evaluated and data were collected on 91. The primary indications for ventriculostomy were subarachnoid hemorrhage (46%), intracerebral hemorrhage (24%), and trauma (22%). Variables prospectively evaluated included pre-incision antibiotics, sterile technique bundling, setting of placement (operating room versus intensive care unit), experience of operator (attending, resident, or physician assistant), catheter type (antibiotic impregnated or not), use of a post-insertion dressing, and in-dwell time of the catheter.  Results: There was only one infection in 91 patients (1.1%). This infection occurred in a patient without an antibiotic-impregnated catheter that was inserted by a resident physician. Compliance with pre-insertion antibiotics was very high, but most other variables had modest deviations in compliance. Conclusion: Infection rate related to external ventricular drainage is very low. Our data suggest that non-antibiotic impregnated catheters may be associated with infection, but that other variables thought to be critical may be of less value. PMID:26430586

  3. A prospective evaluation of the safety and efficacy of the TAXUS Element paclitaxel-eluting coronary stent system for the treatment of de novo coronary artery lesions: Design and statistical methods of the PERSEUS clinical program

    PubMed Central

    2010-01-01

    Background Paclitaxel-eluting stents decrease angiographic and clinical restenosis following percutaneous coronary intervention compared to bare metal stents. TAXUS Element is a third-generation paclitaxel-eluting stent which incorporates a novel, thinner-strut, platinum-enriched metal alloy platform. The stent is intended to have enhanced radiopacity and improved deliverability compared to other paclitaxel-eluting stents. The safety and efficacy of the TAXUS Element stent are being evaluated in the pivotal PERSEUS clinical trials. Methods/Design The PERSEUS trials include two parallel studies of the TAXUS Element stent in single, de novo coronary atherosclerotic lesions. The PERSEUS Workhorse study is a prospective, randomized (3:1), single-blind, non-inferiority trial in subjects with lesion length ≤28 mm and vessel diameter ≥2.75 mm to ≤4.0 mm which compares TAXUS Element to the TAXUS Express2 paclitaxel-eluting stent system. The Workhorse study employs a novel Bayesian statistical approach that uses prior information to limit the number of study subjects exposed to the investigational device and thus provide a safer and more efficient analysis of the TAXUS Element stent. PERSEUS Small Vessel is a prospective, single-arm, superiority trial in subjects with lesion length ≤20 mm and vessel diameter ≥2.25 mm to <2.75 mm that compares TAXUS Element with a matched historical bare metal Express stent control. Discussion The TAXUS PERSEUS clinical trial program uses a novel statistical approach to evaluate whether design and metal alloy iterations in the TAXUS Element stent platform provide comparable safety and improved procedural performance compared to the previous generation Express stent. PERSEUS trial enrollment is complete and primary endpoint data are expected in 2010. PERSEUS Workhorse and Small Vessel are registered at http://www.clinicaltrials.gov, identification numbers NCT00484315 and NCT00489541. PMID:20059766

  4. Prospective evaluation of myopic keratomileusis.

    PubMed

    Swinger, C A; Barker, B A

    1984-07-01

    The initial results of a prospective evaluation of myopic keratomileusis are reported. The procedure was attempted on 42 eyes, with an average follow-up of 10 months. The average reductions of myopia were 7.05 D and 11.59 D when measured by keratometry and refraction, respectively. Regular astigmatism increased by 0.50 D on keratometry, but there was no change in the refractive cylinder. The majority of patients had some irregular astigmatism on corneoscopy. The average percent correction, based on refraction, was 94.1 +/- 24%, and the correlation coefficient was 0.43. Visual rehabilitation was rapid. No patient followed for 1 year or more had a decrease in the best-corrected acuity, and 63% of this group had an average improvement of 1.5 lines with as much as five lines. The final refraction may take up to 6 months to stabilize. Complications consisted of epithelium and debris in the interface and focal necrosis of Bowman's membrane. The technique is difficult but may have application in the visual rehabilitation of the high myope.

  5. 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 Central

    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

    2016-01-01

    Background: 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. Methods: 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. Results: 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%). Conclusions: 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

  6. A Prospective, Multicenter, Randomized Phase II Study to Evaluate the Efficacy and Safety of Eculizumab in Patients with Guillain-Barré Syndrome (GBS): Protocol of Japanese Eculizumab Trial for GBS (JET-GBS)

    PubMed Central

    Yamaguchi, Nobuko; Sato, Yasunori; Nagashima, Kengo; Katayama, Kanako; Sekiguchi, Yukari; Iwai, Yuta; Amino, Hiroshi; Suichi, Tomoki; Yokota, Takanori; Nishida, Yoichiro; Kohara, Nobuo; Hirata, Koichi; Nishiyama, Kazutoshi; Yabe, Ichiro; Kaida, Ken-Ichi; Suzuki, Norihiro; Nodera, Hiroyuki; Tsuji, Shoji; Koike, Haruki; Kira, Jun-Ichi; Hanaoka, Hideki; Kusunoki, Susumu; Kuwabara, Satoshi

    2016-01-01

    Background Guillain-Barré syndrome (GBS) is an immune-mediated neuropathy that causes acute flaccid paralysis. Immunoglobulin and plasma exchange are established treatments for GBS; however, a substantial number of patients, particularly those with severe disease, have poor recovery and residual deficits. Recent studies suggest that complement activation plays a pivotal role in GBS-associated axonal degeneration, and eculizumab is a humanized monoclonal antibody that specifically binds to complement component 5 and potently inhibits complement activation. Objective This clinical trial aims to evaluate the efficacy and safety of eculizumab, a humanized monoclonal antibody directed against complement component 5, for treatment of GBS. Methods The Japanese Eculizumab Trial for GBS (JET-GBS) is a prospective, multicenter, placebo-controlled, double-blind, randomized phase II study conducted at 13 tertiary neurology centers and is funded by the Japan Agency for Medical Research and Development. A total of 33 GBS patients unable to walk independently within 2 weeks from symptom onset (Hughes functional grade 3-5) were randomized at a 2:1 ratio to receive either intravenous eculizumab (900 mg/day) or placebo once weekly for 4 weeks, followed by 20 weeks of follow-up. The primary endpoint for efficacy is the proportion of patients who regain their ability to walk without aid at 4 weeks after the first dose of the study treatment, while primary safety outcomes are the incidence of adverse events and serious adverse events during the trial. Results Enrollment for the trial began in August 2015. This trial is still ongoing. All participants have been enrolled, and follow-up will be completed in October 2016. Conclusions This study is the first to investigate the efficacy and safety of eculizumab for GBS. In case of a positive result, we will plan a phase III trial to investigate this issue in a larger number of patients. ClinicalTrial UMIN Clinical Trials Registry UMIN

  7. Prospective cohort study to evaluate the efficacy of taxane plus platinum and CPT-11plus platinum regimes and to identify prognostic risk factors in cervical cancer patients

    PubMed Central

    Huang, Kecheng; Li, Xiong; Yang, Ru; Shen, Jian; Chen, Zhilan; Qin, Xiaomin; Wang, Shaoshuai; Jia, Yao; Tang, Fangxu; Zhou, Hang; Sun, Haiying; Zhou, Jin; Guo, Lili; Wang, Lin; Qiao, Long; Xiong, Jiaqiang; Wang, Congyi; Ma, Ding; Li, Shuang; Hu, Ting; Wang, Shixuan

    2015-01-01

    Objective: This study was designed to evaluate the response, toxicity and survival of taxanes plus platinum (TP) and CPT-11plus platinum (CP) as neoadjuvant chemotherapies with previously untreated cervical cancer, and to identify prognostic risk factors in these patients. Methods: A cohort study was performed to evaluate the result of TP and CP regimes in the treatment of cervical cancer patients. Results: The study included 567 patients with locally advanced cervical cancer (LACC) staged as FIGO IB-IIB in our clinical departments. Clinical response was found in 76.1% and 78% of patients in the TP and CP arms, respectively, and no treatment-related deaths were reported. During the follow-up period, disease-free survival (DFS) and overall survival (OS) for the TP and CP arms were not different (P = 0.384 for DFS, P = 0.800 for OS). The CP regime showed higher survival rate for endophytic growth style (P = 0.013 for DFS, P = 0.027 for OS). The CP regime also showed higher DFS and OS for G2 tumor (P = 0.027 for DFS, P = 0.032 for OS). In multivariate cox’s proportional hazards regression model, the average death rates were much greater in the non-responder group (HR, 2.68), in the older (> 44 years) group (HR, 2.51), and in the FIGO stage II b patients (HR, 2.84). Conclusions: The CP regime showed higher survival rate for endophytic growth style or G2 tumor. Clinical response, age and FIGO stage were independent prognostic risk factors in this study for both DFS and OS. PMID:26628986

  8. Level of Self-Efficacy of Prospective Mathematics Teachers on Competencies for Planning and Organizing Instruction

    ERIC Educational Resources Information Center

    San, Ismail

    2014-01-01

    The purpose of this study was to determine the level of self-efficacy of prospective mathematics teachers (PMTs) on the competency "planning and organizing instruction" that is one of the teacher competencies identified in 2009 by Ministry of Education. The sample of this study consists of 111 total prospective teachers (PTs) study in…

  9. Internet Self-Efficacy Preferences of Internet Based Environments and Achievement of Prospective Teachers

    ERIC Educational Resources Information Center

    Ozyalcin Oskay, Ozge

    2011-01-01

    The aims of this study are to determine prospective chemistry teachers' internet self-efficacy and preferences of constructivist internet-assisted environments and to examine the relationship between their internet self-efficacy and their preferences for constructivist internet-assisted environments, the relationship between their achievement in…

  10. Stress, Self-Efficacy, Social Support, and Psychological Distress among Prospective Chinese Teachers in Hong Kong.

    ERIC Educational Resources Information Center

    Chan, David W.

    2002-01-01

    Examines teacher stress, self-efficacy, social support, and psychological distress in a sample of Chinese prospective teachers (n=83) in Hong Kong. Reports that the teachers experienced higher levels of symptoms in somatic problems followed by anxiety and dysphoria. Discusses self-efficacy and social support as protective factors for teacher…

  11. Self-Efficacy Beliefs of Prospective Primary Mathematics Teachers about Mathematical Literacy

    ERIC Educational Resources Information Center

    Yavuz, Gunes; Gunhan, Berna Canturk; Ersoy, Esen; Narli, Serkan

    2013-01-01

    The aim of this study was to examine the self-efficacy beliefs about mathematical literacy among teachers of primary school mathematics and the relationship between the self-efficacy beliefs and attitudes towards mathematics. To that end, a descriptive research study was conducted with 550 prospective teachers studying primary school mathematics…

  12. Evaluating ritual efficacy: evidence from the supernatural.

    PubMed

    Legare, Cristine H; Souza, André L

    2012-07-01

    Rituals pose a cognitive paradox: although widely used to treat problems, rituals are causally opaque (i.e., they lack a causal explanation for their effects). How is the efficacy of ritual action evaluated in the absence of causal information? To examine this question using ecologically valid content, three studies (N=162) were conducted in Brazil, a cultural context in which rituals called simpatias are used to treat a great variety of problems ranging from asthma to infidelity. Using content from existing simpatias, experimental simpatias were designed to manipulate the kinds of information that influences perceptions of efficacy. A fourth study (N=68) with identical stimuli was conducted with a US sample to assess the generalizability of the findings across two different cultural contexts. The results provide evidence that information reflecting intuitive causal principles (i.e., repetition of procedures, number of procedural steps) and transcendental influence (i.e., presence of religious icons) affects how people evaluate ritual efficacy.

  13. A Multicenter, Prospective, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Saroglitazar 2 and 4 mg Compared to Pioglitazone 45 mg in Diabetic Dyslipidemia (PRESS V).

    PubMed

    Pai, Vikas; Paneerselvam, A; Mukhopadhyay, Satinath; Bhansali, Anil; Kamath, Dinesh; Shankar, V; Gambhire, Dhiraj; Jani, Rajendrakumar H; Joshi, Shashank; Patel, Pankaj

    2014-01-01

    Dual PPARα/γ can improve both metabolic effects and minimized the side effects caused by either PPARα or PPARγ agonist. The PRESS V study was aimed to evaluate the safety, tolerability, and efficacy of saroglitazar 2 mg and 4 mg capsules (Lipaglyn™; Zydus Code: ZYH1) as compared to high dose pioglitazone in patients with diabetic dyslipidemia. In this 26-week double-blind, parallel arm, phase 3 study patients with hypertriglyceridemia with type 2 diabetes mellitus (BMI > 23 kg/m(2); hypertriglyceridemia: TG > 200 to 400 mg/dL; glycosylated hemoglobin [HbA1c] >7 to 9%) were enrolled from 14 sites in India. After 2 weeks of lifestyle modification, 122 patients were randomized double-blind to 24-week treatment with the study drugs (saroglitazar 2 mg or 4 mg or pioglitazone 45 mg once daily) in a 1:1:1 ratio. The primary end point was change in plasma triglyceride level at week 24. The secondary end points were change in lipid profile and fasting plasma glucose at week 24. Patients who received study medication and had undergone at least 1 postbaseline efficacy evaluation were included in the efficacy analysis. All randomized patients who received at least a single dose were included for safety evaluation. The efficacy analysis included 109 patients (n = 37 in saroglitazar 2 mg; n = 39 in saroglitazar 4 mg; n = 33 in pioglitazone). Saroglitazar 2 mg and 4 mg significantly reduced (P < .001) plasma triglyceride from baseline by 26.4% (absolute change ± SD: -78.2 ± 81.98 mg/dL) and 45% (absolute change ± SD -115.4 ± 68.11 mg/dL), respectively, as compared to pioglitazone -15.5% (absolute change ± SD: -33.3 ± 162.41 mg/dL) at week 24. Saroglitazar 4 mg treatment also demonstrated marked decrease in low-density lipoprotein (5%), very-low-density lipoprotein (45.5%), total cholesterol (7.7%), and apolipoprotein-B (10.9%). Saroglitazar treatment was generally safe and well tolerated. No serious adverse events were reported in saroglitazar treatment arm and no

  14. Evaluating Ritual Efficacy: Evidence from the Supernatural

    ERIC Educational Resources Information Center

    Legare, Cristine H.; Souza, Andre L.

    2012-01-01

    Rituals pose a cognitive paradox: although widely used to treat problems, rituals are causally opaque (i.e., they lack a causal explanation for their effects). How is the efficacy of ritual action evaluated in the absence of causal information? To examine this question using ecologically valid content, three studies (N=162) were conducted in…

  15. Quantitative framework for prospective motion correction evaluation

    PubMed Central

    Pannetier, Nicolas; Stavrinos, Theano; Ng, Peter; Herbst, Michael; Zaitsev, Maxim; Young, Karl; Matson, Gerald; Schuff, Norbert

    2014-01-01

    Purpose Establishing a framework to evaluate performances of prospective motion correction (PMC) MRI considering motion variability between MRI scans. Method A framework was developed to obtain quantitative comparisons between different motion correction setups, considering that varying intrinsic motion patterns between acquisitions can induce bias. Intrinsic motion was considered by replaying in a phantom experiment the recorded motion trajectories from subjects. T1-weighted MRI on five volunteers and two different marker fixations (mouth guard and nose bridge fixations) were used to test the framework. Two metrics were investigated to quantify the improvement of the image quality with PMC. Results Motion patterns vary between subjects as well as between repeated scans within a subject. This variability can be approximated by replaying the motion in a distinct phantom experiment and used as a covariate in models comparing motion corrections. We show that considering the intrinsic motion alters the statistical significance in comparing marker fixations. As an example, two marker fixations, a mouth guard and a nose bridge, were evaluated in terms of their effectiveness for PMC. A mouth guard achieved better PMC performance. Conclusion Intrinsic motion patterns can bias comparisons between PMC configurations and must be considered for robust evaluations. A framework for evaluating intrinsic motion patterns in PMC is presented. PMID:25761550

  16. Efficacy of transforaminal versus interspinous corticosteroid injectionin discal radiculalgia - a prospective, randomised, double-blind study.

    PubMed

    Thomas, E; Cyteval, C; Abiad, L; Picot, M C; Taourel, P; Blotman, F

    2003-10-01

    A prospective, randomised, double-blind study was carried out to compare the respective efficacies of transforaminal and interspinous epidural corticosteroid injections in discal radiculalgia. Thirty-one patients (18 females, 13 males) with discal radicular pain of less than 3 months' duration were consecutively randomised to receive either radio-guided transforaminal or blindly performed interspinous epidural corticosteroid injections. Post-treatment outcome was evaluated clinically at 6 and 30 days, and then at 6 months, but only by mailed questionnaire. At day 6, the between-group difference was significantly in favour of the transforaminal group with respect to Schober's index, finger-to-floor distance, daily activities, and work and leisure activities on the Dallas pain scale. At day 30, pain relief was significantly better in the transforaminal group. At month 6, answers to the mailed questionnaire still showed significantly better results for transforaminal injection concerning pain, daily activities, work and leisure activities and anxiety and depression, with a decline in the Roland-Morris score. In recent discal radiculalgia, the efficacy of radio-guided transforaminal epidural corticosteroid injections was higher than that obtained with blindly-performed interspinous injections.

  17. [Immunological surrogate endpoints to evaluate vaccine efficacy].

    PubMed

    Jin, Pengfei; Li, Jingxin; Zhou, Yang; Zhu, Fengcai

    2015-12-01

    An immunological surrogate endpoints is a vaccine-induced immune response (either humoral or cellular immune) that predicts protection against clinical endpoints (infection or disease), and can be used to evaluate vaccine efficacy in clinical vaccine trials. Compared with field efficacy trials observing clinical endpoints, immunological vaccine trials could reduce the sample size or shorten the duration of a trial, which promote the license and development of new candidate vaccines. For these reasons, establishing immunological surrogate endpoints is one of 14 Grand Challenges of Global Health of the National Institutes of Health (NIH) and the Bill and Melinda Gates Foundation. From two parts of definition and statistical methods for evaluation of surrogate endpoints, this review provides a more comprehensive description.

  18. Analysis of Social Problem Solving and Social Self-Efficacy in Prospective Teachers

    ERIC Educational Resources Information Center

    Erozkan, Atilgan

    2014-01-01

    The purpose of this study is to investigate the relationship between social problem solving and social selfefficacy and the predictive role of social problem solving skills with social self-efficacy. The sample consists of 706 prospective teachers (362 female and 344 male) who are majoring in different fields at Mugla Sitki Kocman University's…

  19. 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…

  20. Relationship of Self-Efficacy and Teacher Knowledge for Prospective Elementary Education Teachers

    ERIC Educational Resources Information Center

    Sharp, Ann C.; Brandt, Lorilynn; Tuft, Elaine A.; Jay, Sandy

    2016-01-01

    This research investigates relationships between prospective teachers' self-efficacy of literacy instruction and their growing knowledge of literacy essentials. An instrument was used that is one part self-ratings of confidence levels in teaching specific literacy skills and one part assessment of literacy knowledge required to teach those skills.…

  1. Prospective safety performance evaluation on construction sites.

    PubMed

    Wu, Xianguo; Liu, Qian; Zhang, Limao; Skibniewski, Miroslaw J; Wang, Yanhong

    2015-05-01

    This paper presents a systematic Structural Equation Modeling (SEM) based approach for Prospective Safety Performance Evaluation (PSPE) on construction sites, with causal relationships and interactions between enablers and the goals of PSPE taken into account. According to a sample of 450 valid questionnaire surveys from 30 Chinese construction enterprises, a SEM model with 26 items included for PSPE in the context of Chinese construction industry is established and then verified through the goodness-of-fit test. Three typical types of construction enterprises, namely the state-owned enterprise, private enterprise and Sino-foreign joint venture, are selected as samples to measure the level of safety performance given the enterprise scale, ownership and business strategy are different. Results provide a full understanding of safety performance practice in the construction industry, and indicate that the level of overall safety performance situation on working sites is rated at least a level of III (Fair) or above. This phenomenon can be explained that the construction industry has gradually matured with the norms, and construction enterprises should improve the level of safety performance as not to be eliminated from the government-led construction industry. The differences existing in the safety performance practice regarding different construction enterprise categories are compared and analyzed according to evaluation results. This research provides insights into cause-effect relationships among safety performance factors and goals, which, in turn, can facilitate the improvement of high safety performance in the construction industry.

  2. Comparative Study for Efficacy and Safety of Adenoidectomy according to the Surgical Method: A Prospective Multicenter Study

    PubMed Central

    Lee, Woo Hyun; Kim, Dong-Kyu; Kim, Sung Wan; Kim, Young Hyo; Nam, Jung Gwon; Park, Seok-Won; Park, Chan-Soon; Bae, Woo Yong; Yeo, Nam-Kyung; Won, Tae-Bin; Lee, Seung Hoon; Lee, Tae-Hoon; Lee, Hyoung Joo; Kim, Sang-Wook; Jeong, Sung-Wook; Choi, Jeong-Seok; Han, Doo Hee; Choi, Ji Ho

    2015-01-01

    Background/Objective There have been several operative techniques for adenoidectomy and their efficacy and morbidity are different according to the technique. This prospective multicenter study was aimed to compare the efficacy and morbidity of coblation adenoidectomy (CA) with those of power-assisted adenoidectomy. Study Design Prospective multi-institutional study. Methods Children who underwent CA, power-assisted adenoidectomy with cauterization (PAA+C) or without cauterization (PAA-C) due to adenoid hypertrophy were enrolled from 13 hospitals between July 2013 and June 2014. Mean operation time, degree of intraoperative bleeding and postoperative bleeding rate were evaluated. Results A total of 388 children (mean age ± standard deviation = 6.6 ± 2.5 years; 245 males and 143 females) were included. According to the adenoidectomy technique, the children were classified into 3 groups: (1) CA (n = 116); (2) PAA+C (n = 153); and (3) PAA-C (n = 119). Significant differences were not found in age and sex among three groups. In the CA group, mean operation time was significantly shorter (P < 0.001) and degree of intraoperative bleeding was significantly less (P < 0.001) compared to PAA+C or PAA-C group. Delayed postoperative bleeding rate of PAA-C group was significantly higher than that of CA or PAA+C group (P = 0.016). Conclusions This prospective multicenter study showed that CA was superior to PAA in terms of mean operation time and degree of intraoperative bleeding. PMID:26267337

  3. Feasibility, Efficacy, and Predictive Factors for the Technical Success of Endoscopic Nasogallbladder Drainage: A Prospective Study

    PubMed Central

    Yane, Kei; Maguchi, Hiroyuki; Katanuma, Akio; Takahashi, Kuniyuki; Osanai, Manabu; Kin, Toshifumi; Takaki, Ryo; Matsumoto, Kazuyuki; Gon, Katsushige; Matsumori, Tomoaki; Tomonari, Akiko; Nojima, Masanori

    2015-01-01

    Background/Aims Several studies have shown the usefulness of endoscopic nasogallbladder drainage (ENGBD) in patients with acute cholecystitis. However, the procedure is difficult, and factors that affect technical success have not yet been clarified. We conducted a prospective study to evaluate the technical feasibility, efficacy, and predictive factors for the technical success of ENGBD in patients with acute cholecystitis. Methods All patients with moderate or severe acute cholecystitis who were enrolled underwent ENGBD between April 2009 and April 2011. Patients with surgically altered anatomy or pancreatobiliary malignancies were excluded. The primary outcomes included technical success, clinical success, and complications. Factors that could affect the technical success were also examined. Results Of the 27 patients who underwent ENGBD during the study period, technical success was achieved in 21 (78%) and clinical improvement was achieved in 20 (95%). Early complications were encountered in four patients (15%). Gallbladder wall thickness (odds ratio [OR], 1.64; 95% confidence interval [CI], 1.08 to 2.47) and age (OR, 1.16; 95% CI, 1.00 to 1.35) were effective predictors of technical failure. Conclusions ENGBD was effective in resolving acute cholecystitis; however, this modality was technically challenging and had a limited success rate. Because of technical difficulties, ENGBD should be reserved for limited indications. PMID:25287172

  4. Contribution of Geophysical Prospecting to Geohazard Evaluation

    SciTech Connect

    Nicolich, Rinaldo

    2006-03-23

    The physical properties of the subsoil are studied using geophysical methods. These studies are always indirect, such as gravimetric, magnetometric, magnetotelluric or reflection-refraction seismic surveys and are often combined to obtain more accurate and reliable results. With these tools the oil industry commonly investigates the sedimentary basins to localize structures that may favor the accumulation of hydrocarbons. Above all, seismic prospecting allow the understanding of the underground geology, defining boundaries of the geological formations as well as mechanical and physical properties of the rocks. New cutting-edge techniques allow high quality data to be obtained in almost all geological contexts and make reflection seismic the most powerful tool in subsurface observations. The seismic method was utilized in geothermal resources investigation, research of water strategic resources, volcanic risks assessment, etc. The refraction method was the first to be used in the exploration of oil reservoirs. At present the industry employs mainly refraction seismics to study shallow formations. Conversely, university researchers have applied wide-angle reflection-refraction surveys to localize deep crustal interfaces analyzing the high amplitudes of the wide-angle reflections and the velocities obtained from the refracted signals. Moho discontinuity and velocity distribution within the crust were mapped out, indicating thickness and boundary conditions in different geological settings. The maps have been used in the analysis of geodynamical behavior and of active movements within the crust, useful for seismotectonic investigations. The further addition of the seismic reflection imaging, with deep penetration and long transects, completed multidisciplinary programs to unravel the structure of the crust with clear seismic images and models. High-resolution application of seismic has a central role in the identification and characterization of seismotectonic and

  5. The Efficacy of Neurofeedback in Patients with Major Depressive Disorder: An Open Labeled Prospective Study.

    PubMed

    Cheon, Eun-Jin; Koo, Bon-Hoon; Choi, Joong-Hyun

    2016-03-01

    The purpose of this study was to evaluate the effect of neurofeedback on depressive symptoms and electrophysiological disturbances in patients with major depressive disorder. We recruited participants suffering from depression to evaluate efficacy of left prefrontal beta with alpha/theta training. An 8-week, prospective, open-label study was undertaken. Twenty participants were recruited. The treatment protocol was twice or three times a week training of beta at F3 with alpha/theta at Pz for 8 weeks. When every visit, patients were received beta training for 30 min, and then alpha/theta training for 30 min. Baseline, 4 and 8 week scores of; the Hamilton rating scale for Depression (HAM-D), the Hamilton rating scale for Anxiety (HAM-A), the Beck Depression Inventory (BDI)-II, the Beck Anxiety Inventory (BAI), Clinical global impression-severity (CGI-S), and pre- and post-treatment resting state EEGs were compared. Interhemispheric alpha power asymmetry (A score) was computed for homologous sites F3-F4. Pre- and post-training clinical assessments revealed significant improvements in HAM-D, HAM-A, BDI, and CGI-S scores. Cumulative response rates by HAM-D were 35.0 and 75.0 % at 4 and 8 weeks, respectively, corresponding cumulative remission rates by HAM-D were 15.0 and 55.0 %, respectively. No significant differences were found between pre- and post-treatment A score. Neurofeedback treatment could improve depressive symptoms significantly. In addition, anxiety symptoms and clinical illness severity decreased significantly after neurofeedback treatment. Despite its several limitations, such as, small sample size and lack of a control group, this study suggested neurofeedback has significant effects in patients with major depressive disorder.

  6. The Relationship between Attitudes of Prospective Physical Education Teachers towards Education Technologies and Computer Self-Efficacy Beliefs

    ERIC Educational Resources Information Center

    Kalemoglu Varol, Yaprak

    2014-01-01

    The aim of research is to investigate the relationship between attitudes of prospective physical education teacher towards education technologies and their computer self-efficacy beliefs. Relational research method has been used in the study. Study group consists of 337 prospective physical education teachers ("M"[subscript age] = 21.57…

  7. 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.…

  8. The Teaching Processes of Prospective Science Teachers with Different Levels of Science-Teaching Self-Efficacy Belief

    ERIC Educational Resources Information Center

    Saka, Mehpare; Bayram, Hale; Kabapinar, Filiz

    2016-01-01

    The concept of self-efficacy, which is an important variable in the teaching process, and how it reflects on teaching have recently been the focus of attention. Therefore, this study deals with the relationship between the science-teaching self-efficacy beliefs of prospective science teachers and their teaching practices. It was conducted with…

  9. The Science Teaching Self-Efficacy of Prospective Elementary Education Majors Enrolled in Introductory Geology Lab Sections

    ERIC Educational Resources Information Center

    Baldwin, Kathryn A.

    2014-01-01

    This study examined prospective elementary education majors' science teaching self-efficacy while they were enrolled in an introductory geology lab course for elementary education majors. The Science Teaching Efficacy Belief Instrument Form B (STEBI-B) was administered during the first and last lab class sessions. Additionally, students were…

  10. Proof Construction and Evaluation Practices of Prospective Mathematics Educators

    ERIC Educational Resources Information Center

    Imamoglu, Yesim; Togrol, Aysenur Yontar

    2015-01-01

    This study was conducted with 93 freshmen and 82 senior prospective mathematicians and mathematics teachers in order to investigate how they construct and evaluate proofs and whether there are any significant differences in their proof construction (with respect to department and grade) and proof evaluation (with respect to department)…

  11. Evaluation of electrode polarity on defibrillation efficacy.

    PubMed

    Bardy, G H; Ivey, T D; Allen, M D; Johnson, G; Greene, H L

    1989-02-15

    The effect of electrode polarity on defibrillation thresholds in humans is unknown. This prospective, randomized evaluation of electrode polarity on defibrillation thresholds was performed in 21 survivors of ventricular fibrillation (VF) undergoing cardiac surgery. Defibrillation was always performed with 2 identical large rectangular, wire mesh electrodes positioned over the anterior wall of the right ventricle and the posterolateral wall of the left ventricle. The initial electrode polarity for the left ventricular (LV) electrode was chosen randomly for determination of the defibrillation threshold. Subsequently, electrode polarity was reversed. The defibrillation threshold was defined as the lowest pulse amplitude that would effectively terminate VF with a single discharge delivered 10 seconds after initiation of an episode of VF with alternating current. For each defibrillation pulse, voltage, current, resistance and delivered energy were recorded. Of the 21 patients, 15 (71%) had a lower defibrillation threshold when the LV electrode was positive, 2 patients (10%) had a lower defibrillation threshold when the LV electrode was negative and 4 patients (19%) had equal defibrillation thresholds (within 0.5 J) regardless of polarity. The mean leading edge defibrillation threshold voltage was 370 +/- 88 volts when the LV electrode was negative and 320 +/- 109 volts (14% less) when the LV electrode was positive (p = 0.014). Mean leading edge defibrillation threshold current was 9.3 +/- 3.1 amps when the LV electrode was negative compared to 7.7 +/- 3.1 amps (17% less) when the LV electrode was positive (p = 0.0033). There were no differences in resistance with the 2 configurations.(ABSTRACT TRUNCATED AT 250 WORDS)

  12. Prospective Evaluation of the Safety and Efficacy of a 1060-nm Large Spot Size, Vacuum-Assisted Hair Removal Diode Laser System in Asian/Pacific Fitzpatrick's Skin Types IV-V Patients.

    PubMed

    Tahiliani, Sushil T; Tahiliani, Harsh S

    2016-11-01

    Laser-based photoepilation of dark skin types demands a delicate combination of appropriate light wavelengths and spot size to achieve optimal epidermal-to-follicular energy absorption ratios. This prospective study assessed the axillary, arm, thigh, and back hair clearing ef cacy of the LightSheer In nity 1060 nm diode laser in 10 Fitzpatrick skin type IV-V patients. Each area was treated up to ve times, at 4-6-week intervals, after which immediate skin responses and adverse events were recorded. Hair count, color and coarseness were assessed before each treatment session, as well as 1, 3, and 6 months following the last session. Both patients and the treating physician rated the degree of improvement with time, and patients also ranked their satisfaction with the treatment outcome. Percent hair reduction from baseline gradually increased with treatment and peaked at 74.6%, 68.4%, and 65.7% for axillary, arm and thigh regions, respectively, 6 months following the last treatment session. Baseline hair growth patterns precluded effective selection of a representative area for hair counting. Patients satisfaction was consistently higher for axillary hair clearance rates, followed by thigh and arm responses. Throughout the follow-up period, the investigator rated 50-67% of the treated axillae as presenting "good" or "very good" hair clearance, and provided similar ratings for 67% of the treated thigh regions at both the 1 and 6 month follow-up sessions. Immediate responses to treatment were mild to moderate and short-lived and no incidents of brosis or scarring were reported. Taken together, the LightSheer In nity 1060 HS Handpiece provided for an ideal ef cacy-safety balance in treating dark-skinned patients, providing for long-term hair clearance with minimal downtime. J Drugs Dermatol. 2016;15(11):1427-1434.

  13. The effect of multimedia cases on science teaching self-efficacy beliefs of prospective teachers in Kenya

    NASA Astrophysics Data System (ADS)

    Nthiga, Peter Rugano

    This study examined the effects of multimedia cases on science teaching self-efficacy beliefs of prospective teachers in Kenya using mixed methods in data collection and analysis. Collaborating with two teacher educators at Central University, I designed and implemented two multimedia case-based intervention lessons, one with prospective chemistry teachers and the other with prospective physics teachers. I determined the changes in self-efficacy beliefs using a pretest and posttest with the Science Teaching Efficacy Beliefs Instrument (STEBI) for N=41 participants. I also collected data using a worksheet during the intervention lesson. When the prospective teachers went for their field practice, I sampled eight of them for in depth interviews to determine what they drew on from the intervention lesson during their classroom teaching. I used Roth McDuffie's et al. (2014) framing to categorize the comments that the prospective teachers made on the worksheet into the four lenses of teacher, students, task or power and participation. I used paired sample t-test to determine the changes in self-efficacy beliefs and then developed profiles of the prospective teachers from the in depth interviews. The results revealed that prospective teachers paid more attention to the actions of the teacher and paid less attention to students' activities. Their attention to the task was predominantly about the cognitive level of the task and almost always focused on the errors they noted. The prospective teacher noticing using the power and participation lens was not clearly delineable from the teacher lens, because most instructional activities that led to more participation were teacher actions. Science teaching efficacy beliefs has two constructs: personal science teaching efficacy (PSTE) and science teaching outcome expectancy (STOE). The PSTE scores were very high at 4.46 out of five on the pretest, and 4.41 on posttest. There was a decrease in the mean scores, but the change was

  14. Pharmacotherapy for Pediatric Generalized Anxiety Disorder: A Systematic Evaluation of Efficacy, Safety and Tolerability

    PubMed Central

    Dobson, Eric T.; Strawn, Jeffrey R.

    2016-01-01

    Background Randomized controlled trials consistently support the efficacy of antidepressants in treating youth with generalized anxiety disorder (GAD), although integrated examinations of efficacy, safety, and tolerability of psychotropic medications in GAD specifically are rare. With this in mind, we sought to describe the efficacy, safety and tolerability of psychopharmacologic interventions in youth with GAD. Methods Randomized, double-blind, placebo-controlled, prospective trials of psychopharmacologic interventions in youth with GAD were identified through a PubMed/Medline (1966–2015) search. Both authors manually reviewed trials and, to evaluate comparative efficacy and tolerability across medications, numbers needed to treat (NNT) (based on Pediatric Anxiety Rating Scale (PARS) remission criteria (PARS ≤8 [1]), and number needed to harm (NNH) for selected treatment-emergent adverse events (TEAEs) were calculated. Finally, treatment-emergent suicidality and taper-emergent/post-study adverse events are reported descriptively. Results Five trials that involved 1,186 patients and evaluated four medications were reviewed and efficacy data were extracted with regard to dimensional measures of anxiety. SSRI/SNRIs demonstrated efficacy in the reduction of anxiety symptoms with NNTs ranging from 2.8 to 9.3. TEAEs varied considerably between studies but tended to be mild and generally did not lead to discontinuation. Conclusions Data from five trials of SSRI/SNRI in youth with GAD, many of whom had co-occurring separation and social anxiety disorders, suggest superiority to placebo and favorable tolerability profiles. PMID:26660158

  15. MIOTIC study: a prospective, multicenter, randomized study to evaluate the long-term efficacy of mobile phone-based Internet of Things in the management of patients with stable COPD.

    PubMed

    Zhang, Jing; Song, Yuan-Lin; Bai, Chun-Xue

    2013-01-01

    Chronic obstructive pulmonary disease (COPD) is a common disease that leads to huge economic and social burden. Efficient and effective management of stable COPD is essential to improve quality of life and reduce medical expenditure. The Internet of Things (IoT), a recent breakthrough in communication technology, seems promising in improving health care delivery, but its potential strengths in COPD management remain poorly understood. We have developed a mobile phone-based IoT (mIoT) platform and initiated a randomized, multicenter, controlled trial entitled the 'MIOTIC study' to investigate the influence of mIoT among stable COPD patients. In the MIOTIC study, at least 600 patients with stable GOLD group C or D COPD and with a history of at least two moderate-to-severe exacerbations within the previous year will be randomly allocated to the control group, which receives routine follow-up, or the intervention group, which receives mIoT management. Endpoints of the study include (1) frequency and severity of acute exacerbation; (2) symptomatic evaluation; (3) pre- and post-bronchodilator forced expiratory volume in 1 second (FEV1) and FEV1/forced vital capacity (FVC) measurement; (4) exercise capacity; and (5) direct medical cost per year. Results from this study should provide direct evidence for the suitability of mIoT in stable COPD patient management.

  16. MIOTIC study: a prospective, multicenter, randomized study to evaluate the long-term efficacy of mobile phone-based Internet of Things in the management of patients with stable COPD

    PubMed Central

    Zhang, Jing; Song, Yuan-lin; Bai, Chun-xue

    2013-01-01

    Chronic obstructive pulmonary disease (COPD) is a common disease that leads to huge economic and social burden. Efficient and effective management of stable COPD is essential to improve quality of life and reduce medical expenditure. The Internet of Things (IoT), a recent breakthrough in communication technology, seems promising in improving health care delivery, but its potential strengths in COPD management remain poorly understood. We have developed a mobile phone-based IoT (mIoT) platform and initiated a randomized, multicenter, controlled trial entitled the ‘MIOTIC study’ to investigate the influence of mIoT among stable COPD patients. In the MIOTIC study, at least 600 patients with stable GOLD group C or D COPD and with a history of at least two moderate-to-severe exacerbations within the previous year will be randomly allocated to the control group, which receives routine follow-up, or the intervention group, which receives mIoT management. Endpoints of the study include (1) frequency and severity of acute exacerbation; (2) symptomatic evaluation; (3) pre- and post-bronchodilator forced expiratory volume in 1 second (FEV1) and FEV1/forced vital capacity (FVC) measurement; (4) exercise capacity; and (5) direct medical cost per year. Results from this study should provide direct evidence for the suitability of mIoT in stable COPD patient management. PMID:24082784

  17. Efficacy of Magnesium Trihydrate of Ursodeoxycholic Acid and Chenodeoxycholic Acid for Gallstone Dissolution: A Prospective Multicenter Trial

    PubMed Central

    Hyun, Jong Jin; Lee, Hong Sik; Kim, Chang Duck; Dong, Seok Ho; Lee, Seung-Ok; Ryu, Ji Kon; Lee, Don Haeng; Jeong, Seok; Kim, Tae Nyeun; Lee, Jin; Koh, Dong Hee; Park, Eun Taek; Lee, Inseok; Yoo, Byung Moo; Kim, Jin Hong

    2015-01-01

    Background/Aims Cholecystectomy is necessary for the treatment of symptomatic or complicated gallbladder (GB) stones, but oral litholysis with bile acids is an attractive alternative therapeutic option for asymptomatic or mildly symptomatic patients. This study was conducted to evaluate the efficacy of magnesium trihydrate of ursodeoxycholic acid (UDCA) and chenodeoxycholic acid (CDCA) on gallstone dissolution and to investigate improvements in gallstone-related symptoms. Methods A prospective, multicenter, phase 4 clinical study to determine the efficacy of orally administered magnesium trihydrate of UDCA and CDCA was performed from January 2011 to June 2013. The inclusion criteria were GB stone diameter ≤15 mm, GB ejection fraction ≥50%, radiolucency on plain X-ray, and asymptomatic/mildly symptomatic patients. The patients were prescribed one capsule of magnesium trihydrate of UDCA and CDCA at breakfast and two capsules at bedtime for 6 months. The dissolution rate, response rate, and change in symptom score were evaluated. Results A total of 237 subjects were enrolled, and 195 subjects completed the treatment. The dissolution rate was 45.1% and the response rate was 47.2% (92/195) after 6 months of administration of magnesium trihydrate of UDCA and CDCA. Only the stone diameter was significantly associated with the response rate. Both the symptom score and the number of patients with symptoms significantly decreased regardless of stone dissolution. Adverse events necessitating discontinuation of the drug, surgery, or endoscopic management occurred in 2.5% (6/237) of patients. Conclusions Magnesium trihydrate of UDCA and CDCA is a well-tolerated bile acid that showed similar efficacy for gallstone dissolution and improvement of gallstone-related symptoms as that shown in previous studies. PMID:26087862

  18. A Prospective Cohort Evaluation of a Robotic, Auto-Navigating Operating Microscope.

    PubMed

    Bohl, Michael A; Oppenlander, Mark E; Spetzler, Robert

    2016-06-30

    The unique challenges inherent to microneurosurgery demand that we stay on the forefront of new surgical technologies. Many believe the next major technological advance in neurosurgery will be the widespread application of image-guided robotics in the operating room. We evaluated a novel technology for image-guided robotic auto-navigation of the operating microscope in a prospectively enrolled cohort of patients. Twenty patients were prospectively enrolled for analysis. Data were collected on the extent of resection, operative time, estimated blood loss, time taken to set up the new software, and complications encountered. Software accuracy, reliability, and usefulness in the case were subjectively evaluated. The most commonly  treated pathologies were cavernous malformation (n = 5), arteriovenous malformation (n = 4), and meningioma (n = 4). The time to set up the new software interface before the start of the operation was <60 seconds in all cases. Subjective evaluation in each case revealed the robotic interface to be accurate, reliable, and useful. The new technology was significantly more useful in deeper lesions. The addition of image-guided robotic auto-positioning features to the operating microscope has a great potential to advance the field of neurosurgery. This study is the first prospective evaluation of such a technology in a patient cohort. The results suggest that the newest robotic auto-positioning technology has the potential to improve the neurosurgeon's efficiency and efficacy, thereby positively impacting patient safety and surgical outcomes, especially in cases involving deep-seated lesions.

  19. A Prospective Cohort Evaluation of a Robotic, Auto-Navigating Operating Microscope

    PubMed Central

    Bohl, Michael A; Oppenlander, Mark E

    2016-01-01

    The unique challenges inherent to microneurosurgery demand that we stay on the forefront of new surgical technologies. Many believe the next major technological advance in neurosurgery will be the widespread application of image-guided robotics in the operating room. We evaluated a novel technology for image-guided robotic auto-navigation of the operating microscope in a prospectively enrolled cohort of patients. Twenty patients were prospectively enrolled for analysis. Data were collected on the extent of resection, operative time, estimated blood loss, time taken to set up the new software, and complications encountered. Software accuracy, reliability, and usefulness in the case were subjectively evaluated. The most commonly  treated pathologies were cavernous malformation (n = 5), arteriovenous malformation (n = 4), and meningioma (n = 4). The time to set up the new software interface before the start of the operation was <60 seconds in all cases. Subjective evaluation in each case revealed the robotic interface to be accurate, reliable, and useful. The new technology was significantly more useful in deeper lesions. The addition of image-guided robotic auto-positioning features to the operating microscope has a great potential to advance the field of neurosurgery. This study is the first prospective evaluation of such a technology in a patient cohort. The results suggest that the newest robotic auto-positioning technology has the potential to improve the neurosurgeon's efficiency and efficacy, thereby positively impacting patient safety and surgical outcomes, especially in cases involving deep-seated lesions. PMID:27493844

  20. [Results of the multicenter prospective study of cerebrolysin safety and efficacy in acute stroke].

    PubMed

    Skwortsova, V I; Stakhovskaia, L V; Shamalov, N A; Kerbikov, O B

    2006-01-01

    The multicenter prospective study of cerebrolysin safety and efficacy included 277 patients with ischemic stroke aged 55-85 years, who received therapy within 12 h from the disease development. Cerebrolysin was used in dosage 10 ml daily along with concomitant standard basic treatment during 10 days after stroke onset in 138 patients. A control group comprised 139 patients who received basic treatment only. A quantitative analysis of the dynamics of neurological deficit revealed the accelerated improvement by NIHSS score, modified Rankin score and Barthel index in the cerebrolysin group on days 10 and 28 (p<0,05). The significant improvement of NIHSS score was observed on day 28 (p<0,05) in patients treated with cerebrolysin within the first 3h after stroke onset comparing to those treated within 6-12h. The trial demonstrated cerebrolysin safety and good tolerability in treatment of ischemic stroke in the carotid artery territory as well as its favorable clinical effect.

  1. Are Prospective Elementary School Teachers' Social Studies Teaching Efficacy Beliefs Related to Their Learning Approaches in a Social Studies Teaching Methods Course?

    ERIC Educational Resources Information Center

    Dündar, Sahin

    2015-01-01

    This study aimed to contribute to the growing literature on learning approaches and teacher self-efficacy beliefs by examining associations between prospective elementary school teachers' learning approaches in a social studies teaching methods course and their social studies teaching efficacy beliefs. One hundred ninety-two prospective elementary…

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

    SciTech Connect

    Ricke, Jens Jürgens, Julian H. W.; Deschamps, Frederic; Tselikas, Lambros; Uhde, Katja; Kosiek, Ortrud; Baere, Thierry De

    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 was 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.

  3. A Review of Relationship between Prospective Science Teachers' Attitudes towards Science Education and Their Self-Efficacy

    ERIC Educational Resources Information Center

    Türer, Betül; Kunt, Halil

    2015-01-01

    In this research, we aim to review relationship between prospective science teachers' attitudes against science education (physics, chemistry, biology, laboratory) and their self-efficacy. Population of the research constitutes 497 students studying Science Education in Department of Elementary Education in Celal Bayar University Faculty of…

  4. Burnout, Self-Efficacy, and Successful Intelligence among Chinese Prospective and In-Service School Teachers in Hong Kong

    ERIC Educational Resources Information Center

    Chan, David W.

    2007-01-01

    This study assessed the three components of burnout (emotional exhaustion, depersonalisation, and reduced personal accomplishment), perceived self-efficacy, and the three triarchic abilities (analytical, synthetic, and practical) of successful intelligence in a sample of 267 Chinese prospective and in-service teachers in Hong Kong. The aim was to…

  5. Testing the prospective evaluation of a new healthcare system

    PubMed Central

    Planitz, Birgit; Sanderson, Penelope; Freeman, Clinton; Xiao, Tania; Botea, Adi; Orihuela, Cristina Beltran

    2012-01-01

    Research into health ICT adoption suggests that the failure to understand the clinical workplace has been a major contributing factor to the failure of many computer-based clinical systems. We suggest that clinicians and administrators need methods for envisioning future use when adopting new ICT. This paper presents and evaluates a six-stage “prospective evaluation” model that clinicians can use when assessing the impact of a new electronic patient information system on a Specialist Outpatients Department (SOPD). The prospective evaluation model encompasses normative, descriptive, formative and projective approaches. We show that this combination helped health informaticians to make reasonably accurate predictions for technology adoption at the SOPD. We suggest some refinements, however, to improve the scope and accuracy of predictions. PMID:23304347

  6. Efficacy methods to evaluate health communication and marketing campaigns.

    PubMed

    Evans, W Douglas; Uhrig, Jennifer; Davis, Kevin; McCormack, Lauren

    2009-06-01

    Communication and marketing are growing areas of health research, but relatively few rigorous efficacy studies have been conducted in these fields. In this article, we review recent health communication and marketing efficacy research, present two case studies that illustrate some of the considerations in making efficacy design choices, and advocate for greater emphasis on rigorous health communication and marketing efficacy research and the development of a research agenda. Much of the outcomes research in health communication and marketing, especially mass media, utilizes effectiveness designs conducted in real time, in the media markets or communities in which messages are delivered. Such evaluations may be impractical or impossible, however, imiting opportunities to advance the state of health communication and marketing research and the knowledge base on effective campaign strategies, messages, and channels. Efficacy and effectiveness studies use similar measures of behavior change. Efficacy studies, however, offer greater opportunities for experimental control, message exposure, and testing of health communication and marketing theory. By examining the literature and two in-depth case studies, we identify advantages and limitations to efficacy studies. We also identify considerations for when to adopt efficacy and effectiveness methods, alone or in combination. Finally, we outline a research agenda to investigate issues of internal and external validity, mode of message presentation, differences between marketing and message strategies, and behavioral outcomes.

  7. Development of an Instrument to Assess Prospective Elementary Teacher Self-Efficacy Beliefs about Equitable Science Teaching and Learning (SEBEST)

    NASA Astrophysics Data System (ADS)

    Ritter, Jennifer M.; Boone, William J.; Rubba, Peter A.

    2001-06-01

    This paper presents an overview of the procedures used to develop and validate an instrument to measure the self-efficacy beliefs of prospective elementary teachers about equitable science teaching and learning. The instrument, titled the SEBEST, was based on the work of Ashton and Webb (1986a, 1986b) and Bandura (1977, 1986). It was modeled after the Science Teaching Efficacy Belief Instrument (STEBI) (Riggs, 1988) and the Science Teaching Efficacy Belief Instrument for Prospective Teachers (STEBI-B) (Enochs & Riggs, 1990). Based on the standardized development procedures used and associated evidence, the SEBEST appears to be a content and construct valid instrument, with high internal reliability qualities. "Most probable response" plots are introduced and used to bring meaning to SEBEST raw scores.

  8. The Efficacy of Stuttering Measurement Training: Evaluating Two Training Programs

    ERIC Educational Resources Information Center

    Bainbridge, Lauren A.; Stavros, Candace; Ebrahimian, Mineh; Wang, Yuedong; Ingham, Roger J.

    2015-01-01

    Purpose: Two stuttering measurement training programs currently used for training clinicians were evaluated for their efficacy in improving the accuracy of total stuttering event counting. Method: Four groups, each with 12 randomly allocated participants, completed a pretest-posttest design training study. They were evaluated by their counts of…

  9. Prospect evaluation as a function of numeracy and probability denominator.

    PubMed

    Millroth, Philip; Juslin, Peter

    2015-05-01

    This study examines how numeracy and probability denominator (a direct-ratio probability, a relative frequency with denominator 100, a relative frequency with denominator 10,000) affect the evaluation of prospects in an expected-value based pricing task. We expected that numeracy would affect the results due to differences in the linearity of number perception and the susceptibility to denominator neglect with different probability formats. An analysis with functional measurement verified that participants integrated value and probability into an expected value. However, a significant interaction between numeracy and probability format and subsequent analyses of the parameters of cumulative prospect theory showed that the manipulation of probability denominator changed participants' psychophysical response to probability and value. Standard methods in decision research may thus confound people's genuine risk attitude with their numerical capacities and the probability format used.

  10. Reinforcement magnitude: an evaluation of preference and reinforcer efficacy.

    PubMed

    Trosclair-Lasserre, Nicole M; Lerman, Dorothea C; Call, Nathan A; Addison, Laura R; Kodak, Tiffany

    2008-01-01

    Consideration of reinforcer magnitude may be important for maximizing the efficacy of treatment for problem behavior. Nonetheless, relatively little is known about children's preferences for different magnitudes of social reinforcement or the extent to which preference is related to differences in reinforcer efficacy. The purpose of the current study was to evaluate the relations among reinforcer magnitude, preference, and efficacy by drawing on the procedures and results of basic experimentation in this area. Three children who engaged in problem behavior that was maintained by social positive reinforcement (attention, access to tangible items) participated. Results indicated that preference for different magnitudes of social reinforcement may predict reinforcer efficacy and that magnitude effects may be mediated by the schedule requirement.

  11. Pethidine efficacy in achieving the ultrasound-guided oblique subcostal transversus abdominis plane block in laparoscopic cholecystectomy: A prospective study

    PubMed Central

    Breazu, Caius Mihai; Ciobanu, Lidia; Bartos, Adrian; Bodea, Raluca; Mircea, Petru Adrian; Ionescu, Daniela

    2017-01-01

    Pethidine is a synthetic opioid with local anesthetic properties. Our goal was to evaluate the analgesic efficacy of pethidine for achieving the ultrasound-guided oblique subcostal transversus abdominis plane (OSTAP) block in laparoscopic cholecystectomy. This prospective, double-blind study included 79 patients of physical status I and II according to American Society of Anesthesiologists, scheduled for elective laparoscopic cholecystectomy. The patients were randomly allocated into three groups, depending on the drug used to achieve preoperative bilateral OSTAP block: 1) OSTAP-Placebo (treated with normal saline); 2) OSTAP-Bupivacaine (treated with 0.25% bupivacaine); and 3) OSTAP-Pethidine (treated with 1% pethidine). The efficacy of pethidine in achieving the OSTAP block was analyzed using visual analog scale (VAS), intraoperative opioid dose, opioid consumption in post anesthesia care unit, and opioid consumption in the first 24 postoperative hours. The pain scores assessed by VAS at 0, 2, 4, 6, 12, and 24 hours were significantly lower in OSTAP-Pethidine than in OSTAP-Placebo group (p < 0.001). The mean intraoperative opioid consumption was significantly lower in OSTAP-Pethidine compared to OSTAP-Placebo group (150 versus 400 mg, p < 0.001), as well as the mean opioid consumption in the first 24 hours (20.4 versus 78 mg, p < 0.001). Comparing VAS assessment between OSTAP-Bupivacaine and OSTAP-Pethidine groups, statistically significant differences were observed only for the immediate postoperative pain assessment (0 hours), where lower values were observed in OSTAP-Pethidine group (p = 0.004). There were no statistically significant differences in the incidence of postoperative nausea and vomiting (p = 0.131) between the groups. The use of 1% pethidine can be an alternative to 0.25% bupivacaine in achieving OSTAP block for laparoscopic cholecystectomy. PMID:28027453

  12. Comparative efficacy of tadalafil versus tamsulosin as the medical expulsive therapy in lower ureteric stone: a prospective randomized trial

    PubMed Central

    Mylarappa, Prasad; Aggarwal, Kuldeep; Patil, Avinash; Joshi, Prarthan; Desigowda, Ramesh

    2016-01-01

    Introduction In recent years, medical expulsive therapy has been used in the management of distal ureteric stones as a supplement to conservative treatment. Therefore, we conducted a prospective randomized study to evaluate the possible role of tadalafil individually in comparison with proven tamsulosin therapy in ureteric stone expulsion. The aim of this study is to compare the safety and efficacy of a phosphodiesterase-5 inhibitor (tadalafil) and an α-1 blocker (tamsulosin) as medical expulsive therapy for distal ureteric calculi. Material and methods Between August 2014 and October 2015, 207 patients who presented with distal ureteric stones of size 5–10 mm were randomly divided into two groups: tadalafil (Group A) and tamsulosin (Group B). Therapy was given for a maximum of 4 weeks. Stone expulsion rate, time to stone expulsion, analgesic use, number of hospital visits for pain, follow-up, endoscopic treatment and adverse effects of drugs were noted. Both groups were compared for normally distributed data by percentage, analysis of variance, and T-test. All the classified and categorical data were analyzed for both groups using the chi-square test. Results A statistically significant expulsion rate of 84.0% in Group A compared with 68.0% in Group B (P value = 0.0130), and shorter stone expulsion time in Group A (14.7±3.8) in comparison to Group B (16.8 ±4.5) was observed. Statistically significant differences were noted in renal colic episodes and analgesic requirement in Group A than Group B. No serious adverse effects were noted. Conclusions Tadalafil is safe, efficacious, and well tolerated as medical expulsive therapy for distal ureteric stones. This study showed that tadalafil increases ureteric stone expulsion quite significantly along with better control of pain and significantly lower analgesic requirement. PMID:27551555

  13. A prospective randomized controlled trial assessing the efficacy of adjunctive hyperbaric oxygen therapy in the treatment of hidradenitis suppurativa.

    PubMed

    Yildiz, Hamza; Senol, Levent; Ercan, Erdinc; Bilgili, Memet Ersan; Karabudak Abuaf, Ozlem

    2016-02-01

    Hyperbaric oxygen therapy (HBOT) appears to enhance wound healing, increase bactericidal activity, and act synergistically with a number of antibiotics. The aim of this study was to evaluate the efficacy of HBOT as an adjunctive therapy in patients with hidradenitis suppurativa (HS) treated with a combination of systemic rifampicin and clindamycin. The study was a prospective, single-center, single-dose, open-label, randomized controlled clinical study of HBOT in patients with moderate to severe HS. Efficacy was measured by modified Sartorius score (SS), HS Severity Index (HSSI), Dermatology Life Quality Index (DLQI), and a visual analog scale (VAS) before treatment and after the completion of 4 and 10 weeks of treatment. Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) levels were also measured. Forty-three patients were enrolled in the study. More patients in the HBOT than in the control group showed a decrease of ≥50% from baseline parameters at week 10 for SS (100%), HSSI (100%), DLQI (95.5%), VAS (100%), ESR (100%), and CRP (72.7%). Clinically and statistically significant improvements from baseline were observed at 4 and 10 weeks in HSSI (P = 0.009 at both), SS (P = 0.021 at both), and DLQI (P = 0.044 at week 4, P = 0.009 at week 10). Adjunctive HBOT was considered to be effective in significantly improving antibiotic treatment of HS. The treatment was well tolerated, and no unexpected safety issues were identified.

  14. Efficacy and safety of moxifloxacin in community acquired pneumonia: a prospective, multicenter, observational study (CAPRIVI)

    PubMed Central

    2014-01-01

    Background Community acquired pneumonia (CAP) is a major cause of morbidity, hospitalization, and mortality worldwide. Management of CAP for many patients requires rapid initiation of empirical antibiotic treatment, based on the spectrum of activity of available antimicrobial agents and evidence on local antibiotic resistance. Few data exist on the severity profile and treatment of hospitalized CAP patients in Eastern and Central Europe and the Middle East, in particular on use of moxifloxacin (Avelox®), which is approved in these regions. Methods CAPRIVI (Community Acquired Pneumonia: tReatment wIth AVelox® in hospItalized patients) was a prospective observational study in 12 countries: Croatia, France, Hungary, Kazakhstan, Jordan, Kyrgyzstan, Lebanon, Republic of Moldova, Romania, Russia, Ukraine, and Macedonia. Patients aged >18 years were treated with moxifloxacin 400 mg daily following hospitalization with a CAP diagnosis. In addition to efficacy and safety outcomes, data were collected on patient history and disease severity measured by CRB-65 score. Results 2733 patients were enrolled. A low severity index (i.e., CRB-65 score <2) was reported in 87.5% of CAP patients assessed (n = 1847), an unexpectedly high proportion for hospitalized patients. Moxifloxacin administered for a mean of 10.0 days (range: 2.0 to 39.0 days) was highly effective: 96.7% of patients in the efficacy population (n = 2152) improved and 93.2% were cured of infection during the study. Severity of infection changed from “moderate” or “severe” in 91.8% of patients at baseline to “no infection” or “mild” in 95.5% at last visit. In the safety population (n = 2595), 127 (4.9%) patients had treatment-emergent adverse events (TEAEs) and 40 (1.54%) patients had serious TEAEs; none of these 40 patients died. The safety results were consistent with the known profile of moxifloxacin. Conclusions The efficacy and safety profiles of moxifloxacin at the recommended

  15. Treating Small Bowel Obstruction with a Manual Physical Therapy: A Prospective Efficacy Study.

    PubMed

    Rice, Amanda D; Patterson, Kimberley; Reed, Evette D; Wurn, Belinda F; Klingenberg, Bernhard; King, C Richard; Wurn, Lawrence J

    2016-01-01

    Small bowel obstructions (SBOs) caused by adhesions are a common, often life-threatening postsurgical complication with few treatment options available for patients. This study examines the efficacy of a manual physical therapy treatment regimen on the pain and quality of life of subjects with a history of bowel obstructions due to adhesions in a prospective, controlled survey based study. Changes in six domains of quality of life were measured via ratings reported before and after treatment using the validated Small Bowel Obstruction Questionnaire (SBO-Q). Improvements in the domains for pain (p = 0.0087), overall quality of life (p = 0.0016), and pain severity (p = 0.0006) were significant when average scores before treatment were compared with scores after treatment. The gastrointestinal symptoms (p = 0.0258) domain was marginally significant. There was no statistically significant improvement identified in the diet or medication domains in the SBO-Q for this population. Significant improvements in range of motion in the trunk (p ≤ 0.001), often limited by adhesions, were also observed for all measures. This study demonstrates in a small number of subjects that this manual physical therapy protocol is an effective treatment option for patients with adhesive small bowel obstructions as measured by subject reported symptoms and quality of life.

  16. Efficacy of 1% acetic acid in the treatment of chronic wounds infected with Pseudomonas aeruginosa: prospective randomised controlled clinical trial.

    PubMed

    Madhusudhan, V L

    2016-12-01

    Chronic wounds are those wounds that are persistent and do not respond to any sort of treatment. The concept of using topical antiseptics on open wounds is to prevent and treat infections. They also help to shorten the time taken to heal the wounds. The use of topical agents on wounds to prevent infection is a minimal ability to develop resistance to the microorganisms. Pseudomonas aeruginosa is a Gram-negative opportunistic pathogen with innate resistance to many antibiotics. In places that are economically backward, these problems get compounded by the inability of patients to afford newer expensive drugs. Topically applied dilute acetic acid, which is cheap and easily available, has been found to be effective in such chronic wounds. In the present study, an attempt has been made to use 1% acetic acid as the sole antimicrobial agent for the treatment of pseudomonal wound infections. A control limb was used in which the wounds were treated with normal saline. Our objective was to evaluate the efficacy of acetic acid in low concentration of 1% in chronic wounds infected with P. aeruginosa. This was a prospective study conducted over a period of 6 months.

  17. Efficacy of low dose gabapentin in acute herpes zoster for preventing postherpetic neuralgia: a prospective controlled study.

    PubMed

    Lee, Eo G; Lee, Hee J; Hyun, Dong J; Min, Kyunghoon; Kim, Dong H; Yoon, Moon S

    2016-05-01

    Postherpetic neuralgia (PHN) is a sequela of herpes zoster that adversely affects quality of life seriously. The risk factors for PHN are well known but the effective interventions that reduce the incidence of PHN are less studied. The objective of this study is to evaluate the efficacy of treatment with gabapentin in patients with acute herpes zoster for preventing PHN. We performed a prospective randomized controlled study of 120 participants diagnosed with acute herpes zoster, aged 50 and over and complaining moderate to severe pain. All patients were treated with valacyclovir and acetaminophen. Half of the participants were assigned to the gabapentin group and received gabapentin 300 mg three times a day additionally. The intensity of pain at every visit and the incidence of PHN in both groups were measured. Total 52 and 49 patients in the gabapentin group and the control group, respectively, had completed 12 weeks of follow-up period. Although the incidence of PHN was higher in the control group, the difference was not statistically significant (6.1% vs. 3.8%, p = 0.67). Our results indicate that the use of low-dose gabapentin in acute herpes zoster seems not effective in the prevention of PHN.

  18. The Prospective Associations between Self-Efficacy and Depressive Symptoms from Early to Middle Adolescence: A Cross-Lagged Model.

    PubMed

    Tak, Yuli R; Brunwasser, Steven M; Lichtwarck-Aschoff, Anna; Engels, Rutger C M E

    2017-04-01

    Over the course of adolescence, an increasing number of adolescents experience depression. In order to effectively target depression, identifying risk factors for depressive symptoms is pivotal. Since low levels of self-efficacy were associated with higher levels of depressive symptoms in previous studies, the current study investigated the bidirectional and prospective associations between depressive symptoms and academic, social and emotional self-efficacy from early to mid adolescence in a cross-lagged path model. The sample consisted of 1,341 adolescents (47 % girls) with a mean age of 14 years, SD = 0.56. Depressive symptoms and self-efficacy levels were assessed every 6 months over a period of 2.5 years. Depressive symptoms predicted subsequent levels of academic and emotional self-efficacy on all time points, and social self-efficacy on one time point. Self-efficacy did not predict subsequent levels of depressive symptoms. There was no evidence of sex differences in the cross-lagged associations between depressive symptoms and self-efficacy levels. Implications of the findings are discussed.

  19. A Psychometric Evaluation of the Self-Presentational Efficacy Scale

    ERIC Educational Resources Information Center

    Lamarche, Larkin; Gammage, Kimberley L.; Sullivan, Philip J.; Gabriel, David A.

    2013-01-01

    This study examined the psychometric properties of the Self-Presentational Efficacy Scale (SPES) developed by Gammage, Hall, and Martin Ginis (2004). University students (196 men and 269 women) completed the SPES and measures of social physique anxiety, fear of negative evaluation, and physical activity. Participants also completed the SPES a…

  20. The Efficacy of Math Coaching: An Evaluative Case Study

    ERIC Educational Resources Information Center

    Dobbins, C. Neelie

    2010-01-01

    There is a lack of implementation of instructional strategies to assist middle school teachers in improving mathematics education for their students. Coaching is one solution to this problem, but its impact on student achievement is unclear. This case study evaluated the relationship between coaching and teacher efficacy and the impact of these…

  1. Efficacy of Synbiotics in Patients with Slow Transit Constipation: A Prospective Randomized Trial

    PubMed Central

    Ding, Chao; Ge, Xiaolong; Zhang, Xueying; Tian, Hongliang; Wang, Hongkan; Gu, Lili; Gong, Jianfeng; Zhu, Weiming; Li, Ning

    2016-01-01

    Synbiotic intake may efficiently restore the balance of gut microbiota and improve gastrointestinal functions. The aim of the study was to evaluate the efficacy of a synbiotic in patients with slow transit constipation. A total of 100 patients with slow transit constipation were randomized to receive either a synbiotic or placebo twice daily for 12 weeks. The primary efficacy endpoints were the clinical remission and improvement rates at weeks 4 and 12. Stool frequency and consistency, colonic transit time (CTT), evacuation and abdominal symptoms, patient assessment of constipation symptoms, gastrointestinal quality-of-life index scores, satisfaction scores, and adverse events were also monitored. The clinical remission rates reached 37.5% at week 4 and 45.8% at week 12 in the treatment group, compared to 13.3% at week 4 and 16.7% at week 12 in the placebo group (p < 0.01 for both comparisons). Over 12 weeks, 64.6% of the patients who received the synbiotic experienced clinical improvement, compared to 29.2% of the patients in the placebo group (p < 0.01). During the intervention period, patients who were treated with the synbiotic exhibited increased stool frequency, improved stool consistency, decreased CTT, and improved constipation-related symptoms. This randomized, placebo-controlled trial suggested that dietary supplementation with a synbiotic improved evacuation-parameters-associated symptoms and colonic motility in patients with slow transit constipation (STC). PMID:27690093

  2. Efficacy of Synbiotics in Patients with Slow Transit Constipation: A Prospective Randomized Trial.

    PubMed

    Ding, Chao; Ge, Xiaolong; Zhang, Xueying; Tian, Hongliang; Wang, Hongkan; Gu, Lili; Gong, Jianfeng; Zhu, Weiming; Li, Ning

    2016-09-28

    Synbiotic intake may efficiently restore the balance of gut microbiota and improve gastrointestinal functions. The aim of the study was to evaluate the efficacy of a synbiotic in patients with slow transit constipation. A total of 100 patients with slow transit constipation were randomized to receive either a synbiotic or placebo twice daily for 12 weeks. The primary efficacy endpoints were the clinical remission and improvement rates at weeks 4 and 12. Stool frequency and consistency, colonic transit time (CTT), evacuation and abdominal symptoms, patient assessment of constipation symptoms, gastrointestinal quality-of-life index scores, satisfaction scores, and adverse events were also monitored. The clinical remission rates reached 37.5% at week 4 and 45.8% at week 12 in the treatment group, compared to 13.3% at week 4 and 16.7% at week 12 in the placebo group (p < 0.01 for both comparisons). Over 12 weeks, 64.6% of the patients who received the synbiotic experienced clinical improvement, compared to 29.2% of the patients in the placebo group (p < 0.01). During the intervention period, patients who were treated with the synbiotic exhibited increased stool frequency, improved stool consistency, decreased CTT, and improved constipation-related symptoms. This randomized, placebo-controlled trial suggested that dietary supplementation with a synbiotic improved evacuation-parameters-associated symptoms and colonic motility in patients with slow transit constipation (STC).

  3. Evaluating efficacy of an environmental policy to prevent biological invasions.

    PubMed

    Bailey, Sarah A; Deneau, Matthew G; Jean, Laurent; Wiley, Chris J; Leung, Brian; MacIsaac, Hugh J

    2011-04-01

    Enactment of any environmental policy should be followed by an evaluation of its efficacy to ensure optimal utilization of limited resources, yet measuring the success of these policies can be a challenging task owing to a dearth of data and confounding factors. We examine the efficacy of ballast water policies enacted to prevent biological invasions in the Laurentian Great Lakes. We utilize four criteria to assess the efficacy of this environmental regulation: (1) Is the prescribed management action demonstrably effective? (2) Is the management action effective under operational conditions? (3) Can compliance be achieved on a broad scale? (4) Are desired changes observed in the environment? The four lines of evidence resulting from this analysis indicate that the Great Lakes ballast water management program provides robust, but not complete, protection against ship-mediated biological invasions. Our analysis also indicates that corresponding inspection and enforcement efforts should be undertaken to ensure that environmental policies translate into increased environmental protection. Similar programs could be implemented immediately around the world to protect the biodiversity of the many freshwater ecosystems which receive ballast water discharges by international vessels. This general framework can be extended to evaluate efficacy of other environmental policies.

  4. Evaluation with evoked and spontaneous electromyography during lumbar instrumentation: a prospective study.

    PubMed

    Welch, W C; Rose, R D; Balzer, J R; Jacobs, G B

    1997-09-01

    The neuroanatomical structures that approximate the bony pedicles of the lumbar spine allow little room for technical error or compromise of the bone during pedicle screw insertion. Currently available neurophysiological monitoring techniques detect compromised bone and nerve root injury after it occurs. The purpose of this prospective study is to evaluate the reliability and efficacy of a unique neurophysiological monitoring technique. This technique provides immediate evaluation of pedicle cortical bone integrity in patients undergoing lumbar fusion with instrumentation by using electrified surgical instruments throughout the pedicle screw fusion procedure. Spontaneous electromyographic (EMG) activity was also monitored. Intraoperative evoked EMG stimulation was performed using a pedicle probe and feeler as monopolar stimulators during the insertion of 164 pedicle bone screws in 32 patients. The EMG response to subthreshold stimulation intensities indicated cortical bone compromise. Immediate and conclusive feedback via evoked EMG activity using stimulating pedicle probes in appropriate muscle groups was successful in identifying pedicle cortical bone compromise in four patients. One false-negative evoked EMG study was noted but was identified via spontaneous EMG activity. Intraoperative EMG monitoring alerted the surgeon that redirection of the pedicle probe or screw was necessary to avoid nerve root irritation or injury and served as an early warning system. Evoked EMG stimulation proved to be reliable and efficacious, especially when used in combination with spontaneous EMG. This technique may provide an added safeguard during implant placement procedures at centers where intraoperative neurophysiological monitoring is routinely performed.

  5. Antecedents and Consequences of Supplier Performance Evaluation Efficacy

    DTIC Science & Technology

    2016-04-30

    Evaluation Efficacy Timothy G. Hawkins,1 Lt Col, USAF (Ret.)—is an Assistant Professor in the Department of Marketing at Western Kentucky University in...Industrial Marketing Management, Journal of Business Ethics, Supply Chain Management: An International Journal, Journal of Marketing Channels, Air...Michael J. Gravier—is an Associate Professor of Marketing and Global Supply Chain Management at Bryant University. He received his PhD in Marketing

  6. Prospective Science Teachers' Self-Efficacy Beliefs about Teaching Science between 6-8 Terms and the Opinions on These Beliefs

    ERIC Educational Resources Information Center

    Önen, Fatma; Muslu Kaygisiz, Gülfem

    2013-01-01

    The formal educational institutions and the society have an important function in acquiring a sense of self-efficacy. Teachers play a role in the formal educational process. The purpose of the study is to examine prospective science teachers' self-efficacy belief level in the 6th to 8th terms and the differences in this process. This survey model…

  7. Turkish Prospective Middle School Mathematics Teachers' Beliefs and Perceived Self-Efficacy Beliefs Regarding the Use of Origami in Mathematics Education

    ERIC Educational Resources Information Center

    Arslan, Okan; Isiksal-Bostan, Mine

    2016-01-01

    The purpose of this study was to investigate beliefs and perceived self-efficacy beliefs of Turkish prospective elementary mathematics teachers in using origami in mathematics education. Furthermore, gender differences in their beliefs and perceived self-efficacy beliefs were investigated. Data for the current study was collected via Origami in…

  8. Anesthetic efficacy of 4% articaine versus 2% lignocaine during the surgical removal of the third molar: A comparative prospective study

    PubMed Central

    Jain, Nikil Kumar; John, Reena Rachel

    2016-01-01

    Aim: The study aimed at evaluating the clinical efficacy of articaine over lidocaine in the surgical removal of impacted mandibular third molars. Objective: The objectives were to compare the onset of anesthesia, pain during injection, during the procedure and after the procedure, compare the duration of anesthesia, and need for re-anesthesia. Materials and Methods: A prospective study was conducted on 70 subjects planned for surgical removal of mandibular third molars. Subjects were randomly administered one of two local anesthetics. The anesthetic agent used was unknown for the patient and the observer who performed the measurements. Results: The differences in latency with 4% articaine (56.57 ± 9.8 s) and with 2% lignocaine (88.26 ± 12.87 s), pain during procedure for articaine 1.31 ± 0.87 and for lignocaine 2.60 ± 1.06, pain after procedure was 0.89 ± 0.58 for articaine and 1.31 ± 1.05 for lignocaine, and mean duration of anesthetic effect for articaine was 231 ± 57.15 min and 174.80 ± 37.02 min for lignocaine, which was statistically significant. For re-anesthesia, 6 out of 35 patients needed re-anesthesia at the frequency of 8.57% for articaine and 13 out of 35 patients needed re-anesthesia at a frequency of 18.57% for lignocaine. Conclusion: The results proved that articaine had a significant faster onset of action and longer duration of action when compared to lignocaine. Hence, the pain experienced by the patients during and after the surgical procedure was significantly less. The study was concluded that articaine is a safe alternative to lignocaine, which is potent and effective in minor surgical procedures such as removal of mandibular third molars. PMID:27212774

  9. Clinical efficacy of intra-articular injections in knee osteoarthritis: a prospective randomized study comparing hyaluronic acid and betamethasone

    PubMed Central

    Trueba Davalillo, Cesáreo Ángel; Trueba Vasavilbaso, Cesáreo; Navarrete Álvarez, José Mario; Coronel Granado, Pilar; García Jiménez, Ozcar Alejandro; Gimeno del Sol, Mercedes; Gil Orbezo, Félix

    2015-01-01

    Background Osteoarthritis (OA) is the most common joint disease and leading cause of disability. Intra-articular (IA) administration of hyaluronic acid (HA) or corticosteroids (CS) have been previously studied, though using insufficient number of patients or short follow-up periods. Objective We evaluate HA and CS in patients with knee OA in terms of clinical efficacy over 12 months. Methods We used a prospective, randomized study with parallel groups. Randomized patients received IA injections of HA or betamethasone (BM). The primary outcomes were improvement in pain using Visual Analog Scale and function in the Western Ontario and McMaster University Osteoarthritis Index (Likert scale). Follow-up visits were scheduled at 3 months, 6 months, 9 months, and 12 months. Results A total of 200 patients were included. Pain was significantly reduced in both groups at the first follow-ups. At 12 months, the mean pain reduction in the HA group was 33.6% (95% CI: 31.1–36.1) compared to 8.2% (95% CI: 5.2–11.1) in BM (P<0.0001). Function improvement was higher in HA through every visit, and mean improvement at 12 months was 47.5% (95% CI: 45.6–49.3) in HA patients vs 13.2% (95% CI: 11.4–14.9) in the BM group (P<0.0001). All patients from both groups achieved the Minimal Clinically Important Improvement (MCII) for both pain and function up to 6 months. At 9 months and 12 months, the MCII figures were higher in HA group with ≥80% compared to ≤10% in BM group (P<0.0001). Adverse reactions were rare and related to the administration procedure. Conclusion Both treatments effectively controlled OA symptoms. BM showed higher short-term effectiveness, while HA showed better long-term effectiveness, maintaining clinical efficacy in a large number of patients 1 year after administration. PMID:27790040

  10. Utility of Gram's stain and efficacy of quantitative cultures for posttraumatic pneumonia: a prospective study.

    PubMed Central

    Croce, M A; Fabian, T C; Waddle-Smith, L; Melton, S M; Minard, G; Kudsk, K A; Pritchard, F E

    1998-01-01

    OBJECTIVE: This prospective trial examined the efficacy of using bronchoalveolar lavage (BAL) for the diagnosis of pneumonia (PN) and the utility of Gram's stain (GS) for dictating empiric therapy. SUMMARY BACKGROUND DATA: Posttraumatic nosocomial PN remains a significant cause of morbidity and mortality. However, its diagnosis is elusive, especially in multiply injured patients. The systemic inflammatory response syndrome of fever, leukocytosis, and a hyperdynamic state is common in trauma patients, especially patients with pulmonary contusion. Bronchoscopy with BAL with quantitative cultures of the lavage effluent may distinguish between PN and systemic inflammatory response syndrome, and GS of the lavage effluent may guide empiric therapy before quantitative culture results. METHODS: Mechanically ventilated trauma patients with a clinical diagnosis of PN (fever, leukocytosis, purulent sputum, and new or changing infiltrate on chest radiograph) underwent bronchoscopy with BAL. Effluent was sent for GS and quantitative cultures. The diagnostic threshold for PN was > or =10(5) colony-forming units (CFU)/mL, and antibiotics were continued. Antibiotics were stopped for < 10(5) CFU/mL and the diagnosis of systemic inflammatory response syndrome was made. Causative organisms for PN were compared to GS. RESULTS: Over a 2-year period, 232 patients underwent 443 bronchoscopies with BAL (71% men, 29% women; mean age, 41). The mean injury severity score was 30. Sixty percent of the patients had pulmonary contusion, and 59% were cigarette smokers. The overall incidence of PN was 39% and was no different regardless of the number of BALs a patient had. The false-negative rate of BAL was 7%. GS identified gram-positive organisms in 80% of patients with gram-positive PN and 40% of patients with gram-negative PN. GS identified gram-negative organisms in 52% of patients with gram-positive PN and 77% with gram-negative PN. The duration of the intensive care unit stay relative to

  11. G6PD Deficiency and Antimalarial Efficacy for Uncomplicated Malaria in Bangladesh: A Prospective Observational Study

    PubMed Central

    Ley, Benedikt; Alam, Mohammad Shafiul; Thriemer, Kamala; Hossain, Mohammad Sharif; Kibria, Mohammad Golam; Auburn, Sarah; Poirot, Eugenie; Price, Ric N.; Khan, Wasif Ali

    2016-01-01

    Background The Bangladeshi national treatment guidelines for uncomplicated malaria follow WHO recommendations but without G6PD testing prior to primaquine administration. A prospective observational study was conducted to assess the efficacy of the current antimalarial policy. Methods Patients with uncomplicated malaria, confirmed by microscopy, attending a health care facility in the Chittagong Hill Tracts, Bangladesh, were treated with artemether-lumefantrine (days 0–2) plus single dose primaquine (0.75mg/kg on day2) for P. falciparum infections, or with chloroquine (days 0–2) plus 14 days primaquine (3.5mg/kg total over 14 days) for P. vivax infections. Hb was measured on days 0, 2 and 9 in all patients and also on days 16 and 30 in patients with P. vivax infection. Participants were followed for 30 days. The study was registered with the clinical trials website (NCT02389374). Results Between September 2014 and February 2015 a total of 181 patients were enrolled (64% P. falciparum, 30% P. vivax and 6% mixed infections). Median parasite clearance times were 22.0 (Interquartile Range, IQR: 15.2–27.3) hours for P. falciparum, 20.0 (IQR: 9.5–22.7) hours for P. vivax and 16.6 (IQR: 10.0–46.0) hours for mixed infections. All participants were afebrile within 48 hours, two patients with P. falciparum infection remained parasitemic at 48 hours. No patient had recurrent parasitaemia within 30 days. Adjusted male median G6PD activity was 7.82U/gHb. One male participant (1/174) had severe G6PD deficiency (<10% activity), five participants (5/174) had mild G6PD deficiency (10–60% activity). The Hb nadir occurred on day 2 prior to primaquine treatment in P. falciparum and P. vivax infected patients; mean fractional fall in Hb was -8.8% (95%CI -6.7% to -11.0%) and -7.4% (95%CI: -4.5 to -10.4%) respectively. Conclusion The current antimalarial policy remains effective. The prevalence of G6PD deficiency was low. Main contribution to haemolysis in G6PD normal

  12. A prospective two-armed trial assessing the efficacy and performance of a silver dressing used postoperatively on high-risk, clean surgical wounds.

    PubMed

    Schwartz, Jamie; Goss, Selena; Facchin, Federico; Manizate, Fotini; Gendics, Cynthia; Braitman, Elissa; Lantis, John

    2014-04-01

    Surgical site infections (SSI) are a known complication of surgery. Silver-containing wound treatments are popular, despite the lack of evidence of SSI reduction. A two-armed study was conducted between July 2007 and November 2008 to evaluate the efficacy and ease of use of a postoperative silver dressing. In the first arm of the study, patients undergoing clean general, vascular, orthopedic, and neurosurgical procedures were allocated to receive a postoperative silver dressing (POSD) or a standard dressing of nonstick gauze under a fluid occlusive dressing. Outcome variables included the incidence of antibiotic initiation for SSI, clinical signs of infection, and leukocyte counts. The second arm of the study was a prospective case series designed to evaluate the performance and handling characteristics of the POSD. Onehundred- ninety-nine (199) patients (mean age 59.2 [range 21-94] years) were enrolled in the first arm of the study. Three out of 99 (3%) patients in the POSD and six out of 100 (6%) control group patients received antibiotic therapy for SSI (P = 0.498). Differences in the percentage of patients with clinical signs of infection following surgery also were not statistically significant (POSD: n = 24, 24.2%; control: n = 30, 30%; P = 0.426). In the second arm, 34 out of 36 patients rated the study dressing easy to apply in (94%), and no pain on removal was noted in 38 out of 57 (66.7%) assessments. No patients in the dressing performance cohort developed an SSI. Prospective, randomized, controlled clinical studies with large sample sizes are warranted to evaluate the efficacy and cost-effectiveness of the POSD.

  13. Efficacy of granulocyte and monocyte apheresis for antibiotic-refractory pouchitis after proctocolectomy for ulcerative colitis: an open-label, prospective, multicentre study

    PubMed Central

    Yamamoto, Takayuki; Tanaka, Toshiaki; Yokoyama, Tadashi; Shimoyama, Takahiro; Ikeuchi, Hiroki; Uchino, Motoi; Watanabe, Toshiaki

    2016-01-01

    Background: Granulocyte and monocyte apheresis (GMA) has shown therapeutic efficacy in active ulcerative colitis (UC). We thought that in patients with pouchitis after proctocolectomy for UC, GMA might produce immunological effects in the intestinal mucosa, and improve clinical symptoms. This prospective study was to evaluate the efficacy of GMA for antibiotic-refractory pouchitis after proctocolectomy for UC. Methods: A total of 13 patients with pouchitis disease activity index (PDAI) > 7 unresponsive to 2 weeks of antibiotic therapy were included. All patients received 10 GMA sessions at 2 sessions/week over 5 consecutive weeks. The primary endpoints were response (a decrease of ⩾3 points in the PDAI) and remission (PDAI < 4). Secondary endpoints included reduction of white blood cells (WBCs), C-reactive protein (CRP), faecal markers (calprotectin and lactoferrin), reduction of the PDAI endoscopic subscore, and GMA safety. Results: The median PDAI score was significantly decreased from 11 (range, 9–15) at entry to 9 (range, 6–13) after the GMA therapy (p = 0.02). A total of six patients (46%) responded to the treatment, but none achieved remission. The median endoscopic subscore (maximum: 6) was 5 (range, 4–6) at entry and 5 (range, 1–6) after the treatment (p = 0.10). None of the laboratory markers (WBCs, CRP, faecal calprotectin and lactoferrin) significantly changed during the treatment. Transient adverse events (AEs) were observed in two patients (15%), dyspnoea in one and headache in one. The AEs were not serious, and all patients completed the 10 GMA sessions. Conclusions: GMA has a good safety profile, but its efficacy appears to be limited in the management of chronic refractory pouchitis. However, a large controlled study should be conducted to evaluate the efficacy of GMA therapy in patients with pouchitis at an earlier clinical stage, before the disease has become refractory to conventional medical therapy. PMID:28203278

  14. Efficacy of 0.25% Lemongrass Oil Mouthwash: A Three Arm Prospective Parallel Clinical Study

    PubMed Central

    Mohanty, Pritam; Tangade, Pradeep; Rajput, Prashant; Batra, Manu

    2015-01-01

    Background Chlorhexidine mouthwash has earned eponym of gold standard to treat and/or prevent periodontal diseases. However, the present study was carried out to explore an alternative herbal mouthwash. Aim To compare the anti-plaque and anti-gingivitis efficacy of a 0.25% lemongrass oil mouthwash to that of 0.2% chlorhexidine mouthwash. Materials and Methods A double-blinded parallel designed clinical trial with 60 subjects was taken for the study. Baseline plaque index (PI) & gingival index (GI) score was recorded. Oral prophylaxis was done and the plaque score was set at zero. Then, subjects were randomly allocated into 3 groups (N=20 in each): 0.25% lemongrass oil mouthwash, 0.2% chlorhexidine mouthwash and oral prophylaxis only. Subjects were asked to swish with respective mouthwash twice daily for 21 days. Subjects were again re-evaluated on 14th and 21st day for GI and PI. Comparison of the mean difference among the variables was performed by parametric tests. Results Lemongrass oil mouthwash group showed highest reduction in GI & PI at both 14th and 21st day, which was statistically significant (p≤0.05). Conclusion Lemongrass oil mouthwash can also be used as a good herbal alternative to chlorhexidine mouthwash, so further studies are needed. PMID:26557608

  15. Therapeutic efficacy of artemether-lumefantrine for Plasmodium vivax infections in a prospective study in Guyana

    PubMed Central

    2012-01-01

    Background In Guyana, chloroquine + primaquine is used for the treatment of vivax malaria. A worldwide increase of chloroquine resistance in Plasmodium vivax led to questioning of the current malaria treatment guidelines. A therapeutic efficacy study was conducted using artemether-lumefantrine + primaquine against P. vivax to evaluate a treatment alternative for chloroquine. Methods From 2009 to 2010, a non-controlled study in two hospitals in Guyana was conducted. A total 61 patients with P. vivax infection were treated with artemether-lumefantrine as a six-dose regimen twice a day for three days with additional 0.25 mg/kg/d primaquine at day 0 for 14 days. Clinical and parasitological parameters were followed on days 0,1,2,3,7,14 and 28 in agreement with WHO guidelines. Plasmodium vivax DNA from eight patients was analysed for pvmdr1, molecular marker of resistance. Results Artemether-lumefantrine cleared 100% of parasites on day 1, but two patients (3%) had recurrence of parasites on day 28, suggesting relapse. No pvmdr1 Y976F polymorphism was detected. The treatment regimen was well tolerated. Conclusions In Guyana, artemether-lumefantrine represents an adequate treatment option against P. vivax when combined with primaquine. Availability of this alternative will be of great importance in case of emerging chloroquine resistance against P. vivax. PMID:23083017

  16. Self-Efficacy Perceptions of Prospective Social Studies Teachers in Relation to History Teaching

    ERIC Educational Resources Information Center

    Yilmaz, Ali

    2009-01-01

    Self-efficacy is one of the important concepts of the social cognitive theory, and can be defined as individual's perception of his or her own capabilities for organizing and successfully executing the courses of action required to attain designated types of performance. Teachers with high self-efficacy perception can contribute to creation of a…

  17. Exploring Prospective EFL Teachers' Perceived Self-Efficacy and Beliefs on English Language Learning

    ERIC Educational Resources Information Center

    Genç, Gülten; Kulusakli, Emine; Aydin, Savas

    2016-01-01

    Learners' perceived self-efficacy and beliefs on English language learning are important in education. Taking into consideration the important impact of individual variables on language learning, this study seeks to highlight the relationship between Turkish EFL learners' beliefs about language learning and their sense of self-efficacy. The…

  18. Efficacy of EZStep in the management of plantar fasciitis: a prospective, randomized study.

    PubMed

    Al-Bluwi, Mohammed T; Sadat-Ali, Mir; Al-Habdan, Ibrahim M; Azam, Mohammed Q

    2011-08-01

    Plantar fasciitis is one of the most common causes of heel pain. Despite extensive efforts foot surgeons continue to debate the best modality of treatment. Analgesics, shoe inserts, stretching exercises, steroid injection, night splints, and extracorporeal shock wave therapy have proved effective in one group but fail in others. This study evaluated the efficacy of EZStep, a new foot brace for the management of plantar fasciitis. A total of 198 patients were randomized in 2 groups; group 1 (study group) received nonsteroidal anti-inflammatory drugs (NSAIDs; 4-6 weeks) and EZStep whereas group 2 (control group) received either NSAID and physiotherapy alone (2A) or NSAID, physiotherapy, and local steroid injection (2B). None of the patients received over-the-counter insoles or strapping of plantar arch to avoid any bias in randomization. Evaluations included measurement of weight and height, visual analog scale (VAS) for pain, and Short-Form McGill Pain Questionnaire (SFMPQ). After 8 weeks, patients were reevaluated, and assessment for the VAS and SFMPQ with treatment outcome was performed. Patients with VAS scores ≤3 were considered as excellent, ≥4 as good, and ≥7 as poor. The posttreatment evaluation showed that VAS scores were in the range from 2.97 ± 1.06 to 7.64 ± 2.9 (2A), P = .001, 95% confidence interval (CI) <-4.104; for 2B P = .001, CI <-2.44, and SFMPQ was 21.7 ± 4.5 and 69.2 ± 5.8 (group 2A; P = .001, 95% CI <-46.44). Compared with group 2B the SFMPQ was 66.5 ± 4.3 (P = .001, 95% CI <-30.720). In group 1 as per VAS, 86 (73.5%) were evaluated as excellent, 15 (12.8%) as good, and 16 (13.6%) as poor. Our study shows that the regular use of EZStep with short course of NSAIDs (4-6 weeks) was effective in ameliorating symptoms in more than 85% of patients suffering from plantar fasciitis.

  19. Thrombotic complications of implanted central venous access devices: prospective evaluation.

    PubMed

    Labourey, Jean-Luc; Lacroix, Philippe; Genet, Dominique; Gobeaux, François; Martin, Jean; Venat-Bouvet, Laurence; Lavau-Denes, Sandrine; Maubon, Antoine; Tubiana-Mathieu, Nicole

    2004-05-01

    Implanted venous access devices (IVAD) are routinely used in oncologic patients. Thrombotic complication is a source of morbidity. During one year 246 patients with different solid neoplastic diseases received IVAD for chemotherapy administration. Two hundred forty-nine IVAD were placed percutaneously or by surgical cutdown. IVAD were flushed immediately after implantation with 3-5 mL of heparinized saline (100 U/mL). No monthly flush was required. A prospective evaluation of thrombotic complications was realised. in event of catheter dysfunction and/or clinical symptoms of phlebitis, a catheter opacification and/or a Doppler ultrasonography were performed. Twenty-three catheter dysfunctions were noted, corresponding to 13 catheter occlusions. Twelve patients presented clinical symptoms of phlebitis. Eleven venous thrombosis were diagnosed in this group; 10 by echo-Doppler and one by scanography. A unvaried statistic analysis using Fisher's test was performed to detect risk factors. Two factors were identified: the position of catheter tip above T4 (p < 0.001) and mediastinal or cervical lymph nodes larger than 6 cm (p < 0.001). The first increased the risk of catheter occlusion and the second increased the risk of phlebitis.

  20. Evaluation of the efficacy of two leishmanins in asymptomatic dogs.

    PubMed

    Solano-Gallego, L; Llull, J; Arboix, M; Ferrer, L; Alberola, J

    2001-12-03

    There are few studies in dogs concerning leishmanin skin test. We evaluated and compared the efficacy of two leishmanin preparations for the detection of dog Leishmania cellular-mediated immunity. Clinically healthy dogs living in an endemic area were studied. A leishmanin preparation 1 (3 x 10(8) promastigotes/ml) was superior to a leishmanin preparation 2 (5 x 10(6) promastigotes/ml), measured as the percentage of positive reactions and the diameter of the induced induration. The leishmanin skin test is a valuable tool, although the results show that the degree of response, as it has been shown in human beings, depends on the preparation used.

  1. Teacher Leadership and Teacher Efficacy: A Correlational Study Comparing Teacher Perceptions of Leadership and Efficacy and Teacher Evaluation Scores from the North Carolina Educator Evaluation System

    ERIC Educational Resources Information Center

    Guenzler, April M.

    2016-01-01

    This study sought to identify correlations between constructs of teacher leadership, teacher efficacy, and teacher evaluation. Teacher perceptual data of support of teacher leadership, perceptual data on personal teacher efficacy, and teacher self-reported scores from the North Carolina Educator Evaluation System were gathered. The relationships…

  2. SECONDARILY INFECTED NON-STRUVITE UROLITHIASIS: A PROSPECTIVE EVALUATION

    PubMed Central

    de Cógáin, Mitra R.; Lieske, John C.; Vrtiska, Terri J.; Tosh, Pritish K.; Krambeck, Amy E.

    2014-01-01

    Purpose To characterize patients who form non-struvite stones associated with infection (secondarily infected calculi) and to define the bacteria associated with these. Materials and Methods Patients undergoing percutaneous nephrolithotomy were prospectively recruited. Medical records were reviewed and stones were analyzed using microCT and infrared spectroscopy. A fragment of each stone was sent for bacterial culture. Patients were categorized by stone culture results (SC+/−) and the presence of struvite (ST+/−). Fisher’s exact test was used for comparison of proportion. Sterility of intraoperative SC was established with independently collected controls. Results In total, 125 patients were enrolled: 24 SC+/ST−, 19 SC+/ST+ and 82 SC−/ST−. Proportions of patients with prior urologic surgery, diabetes, and immunodeficiency were similar between groups. Patients with neurogenic bladder were more likely to have SC+/ST+ stones or SC+/ST− stones than SC−/ST− stones (26% vs. 8% vs. 0%, respectively, p<0.01). Among patients with metabolic evaluations, hypocitraturia was found in 31.6% (6/19) SC+/ST− patients, 46.7% (7/15) SC+/ST+ patients, and 26.0% (19/73) of SC−/ST− patients (p=0.28). Approximately 40% of cultured organisms in the secondarily infected calculi possessed urease and another 40% citrate lyase activity. Conclusions Secondarily infected stones were detected in approximately 20% of this surgical cohort and may be more common than previously appreciated. Neurogenic bladder appeared to predispose patients to either struvite or secondarily infected stones. The role of bacterial infection in stone formation is unclear, but may include alteration of urinary components, acting as a nidus for crystallization, or inducing inflammation. PMID:25306481

  3. Prospective evaluation of femoral head viability following femoral neck fracture

    SciTech Connect

    Binkert, B.; Kroop, S.A.; Nepola, I.V.; Grantham, A.S.; Alderson, P.O.

    1984-01-01

    The bone scans of 33 patients (pts) with recent subcapital fractures (fx) of the femur were evaluated prospectively to determine their value in predicting femoral head visability. Each of the 33 pts (ll men, 22 women, age range 30-92) had a pre-operative bone scan within 72 hrs of the fx (23 pts within 24 hrs). Anterior and posterior planar views of both hips and pinhole views (50% of pts) were obtained 2 hrs after administration of Tc-99m HDP. The femoral head was classified as perfused if it showed the same activity as the opposite normal side or if it showed only slightly decreased activity. Femoral heads showing absent activity were classified as nonperfused. Overall, 20 of the 33 pts showed a photopenic femoral head on the side of the fx. Only 2 pts showed increased activity at hte site of the fx. Internal fixation of the fx was performed in 23 pts, 12 of whom had one or more follow-up scans. Five of these 12 pts showed absent femoral head activity on their initial scan, but 2 showed later reperfusion. The other 7 pts showed good perfusion initially, with only 1 later showing decreased femoral head activity. The other 10 pts (7 of whom had absent femoral head activity) had immediate resection of the femoral head and insertion of a Cathcart prosthesis. The results suggest that femoral head activity seen on a bone scan in the immediate post-fx period is not always a reliable indicator of femoral head viability. Decreased femoral head activity may reflect, in part, compromised perfusion secondary to post-traumatic edema, with or without anatomic disruption of the blood supply.

  4. Evaluation of the Program Effectiveness of Research Competence Development in Prospective Elementary School Teachers

    ERIC Educational Resources Information Center

    Khan, Natalya N.; Kolumbayeva, Sholpan Zh.; Karsybayeva, Raissa K.; Nabuova, Roza A.; Kurmanbekova, Manshuk B.; Syzdykbayeva, Aigul Dzh.

    2016-01-01

    To develop research competence in prospective teachers, a system of methods for diagnostics and formation of this competence in prospective elementary school teachers in the training process is designed. To diagnose the research competence, a series of techniques were used that allow subtle evaluation of each competence research component:…

  5. Prospect evaluation of shallow I-35 reservoir of NE Malay Basin offshore, Terengganu, Malaysia

    NASA Astrophysics Data System (ADS)

    Janjua, Osama Akhtar; Wahid, Ali; Salim, Ahmed Mohamed Ahmed; Rahman, M. Nasir B. A.

    2016-02-01

    A potential accumulation of hydrocarbon that describes significant and conceivable drilling target is related to prospect. Possibility of success estimation, assuming discovery of hydrocarbons and the potential recoverable quantities range under a commercial development program are the basis of Prospect evaluation activities. The objective was to find the new shallow prospects in reservoir sandstone of I -Formation in Malay basin. The prospects in the study area are mostly consisting of faulted structures and stratigraphic channels. The methodology follows seismic interpretation and mapping, attribute analysis, evaluation of nearby well data i.e., based on well - log correlation. The petrophysical parameters analogue to nearby wells was used as an input parameter for volumetric assessment. Based on analysis of presence and effectiveness, the prospect has a complete petroleum system. Two wells have been proposed to be drilled near the major fault and stratigraphic channel in I-35 reservoir that is O-1 and O-2 prospects respectively. The probability of geological success of prospect O-1 is at 35% while for O-2 is 24%. Finally, for hydrocarbon in place volumes were calculated which concluded the best estimate volume for oil in O-1 prospect is 4.99 MMSTB and O-2 prospect is 28.70 MMSTB while for gas is 29.27 BSCF and 25.59 BSCF respectively.

  6. Prospect evaluation of shallow I-35 reservoir of NE Malay Basin offshore, Terengganu, Malaysia

    SciTech Connect

    Janjua, Osama Akhtar Wahid, Ali Salim, Ahmed Mohamed Ahmed; Rahman, M. Nasir B. A.

    2016-02-01

    A potential accumulation of hydrocarbon that describes significant and conceivable drilling target is related to prospect. Possibility of success estimation, assuming discovery of hydrocarbons and the potential recoverable quantities range under a commercial development program are the basis of Prospect evaluation activities. The objective was to find the new shallow prospects in reservoir sandstone of I –Formation in Malay basin. The prospects in the study area are mostly consisting of faulted structures and stratigraphic channels. The methodology follows seismic interpretation and mapping, attribute analysis, evaluation of nearby well data i.e., based on well – log correlation. The petrophysical parameters analogue to nearby wells was used as an input parameter for volumetric assessment. Based on analysis of presence and effectiveness, the prospect has a complete petroleum system. Two wells have been proposed to be drilled near the major fault and stratigraphic channel in I-35 reservoir that is O-1 and O-2 prospects respectively. The probability of geological success of prospect O-1 is at 35% while for O-2 is 24%. Finally, for hydrocarbon in place volumes were calculated which concluded the best estimate volume for oil in O-1 prospect is 4.99 MMSTB and O-2 prospect is 28.70 MMSTB while for gas is 29.27 BSCF and 25.59 BSCF respectively.

  7. Comparison of Clinical and Physiological Efficacies of Different Intermittent Sequential Pneumatic Compression Devices in Preventing Deep Vein Thrombosis: A Prospective Randomized Study

    PubMed Central

    Koo, Ki Hyoung; Ahn, Ji Hyun; Kwon, Jae Hyun; Cho, Keun-Tae

    2014-01-01

    Background There are few comparative studies about the optimal method of pneumatic compression to prevent deep vein thrombosis (DVT). The aim of this prospective randomized study was to compare venous hemodynamic changes and their clinical influences between two graded sequential compression groups (an alternate sequential compression device [ASCD] vs. a simultaneous sequential compression device [SSCD]). Methods In total, 34 patients (68 limbs) undergoing knee and spine operations were prospectively randomized into two device groups (ASCD vs. SSCD groups). Duplex ultrasonography examinations were performed on the 4th and 7th postoperative days for the detection of DVT and the evaluation of venous hemodynamics. Continuous data for the two groups were analyzed using a two-tailed, unpaired t-test. Relative frequencies of unpaired samples were compared using Fisher exact test. Mixed effects models that might be viewed as ANCOVA models were also considered. Results DVT developed in 7 patients (20.6%), all of whom were asymptomatic for isolated calf DVTs. Two of these patients were from the ASCD group (11.8%) and the other five were from the SSCD group (29.4%), but there was no significant difference (p = 0.331). Baseline peak velocity, mean velocity, peak volume flow, and total volume flow were enhanced significantly in both device groups (p < 0.001). However, the degrees of flow and velocity enhancement did not differ significantly between the groups. The accumulated expelled volumes for an hour were in favor of the ASCD group. Conclusions Both graded sequential compression devices showed similar results both in clinical and physiological efficacies. Further studies are required to investigate the optimal intermittent pneumatic compression method for enhanced hemodynamic efficacy and better thromboprophylaxis. PMID:25436073

  8. Evaluation of Influenza Vaccination Efficacy: A Universal Epidemic Model

    PubMed Central

    Bazhan, Sergei I.

    2016-01-01

    By means of a designed epidemic model, we evaluated the influence of seasonal vaccination coverage as well as a potential universal vaccine with differing efficacy on the aftermath of seasonal and pandemic influenza. The results of the modeling enabled us to conclude that, to control a seasonal influenza epidemic with a reproduction coefficient R0 ≤ 1.5, a 35% vaccination coverage with the current seasonal influenza vaccine formulation is sufficient, provided that other epidemiology measures are regularly implemented. Increasing R0 level of pandemic strains will obviously require stronger intervention. In addition, seasonal influenza vaccines fail to confer protection against antigenically distinct pandemic influenza strains. Therefore, the necessity of a universal influenza vaccine is clear. The model predicts that a potential universal vaccine will be able to provide sufficient reliable (90%) protection against pandemic influenza only if its efficacy is comparable with the effectiveness of modern vaccines against seasonal influenza strains (70%–80%); given that at least 40% of the population has been vaccinated in advance, ill individuals have been isolated (observed), and a quarantine has been introduced. If other antiepidemic measures are absent, a vaccination coverage of at least 80% is required. PMID:27668256

  9. Niger Delta basin oil and gas prospects evaluated

    SciTech Connect

    Not Available

    1992-09-28

    This paper reports that an ambitious project to map African oil and gas prospects has produced its first findings in a report on the Niger Delta basin. In Nigeria, 73% of discoveries are smaller than 50 million bbl, with a 42% success rate for wildcats. There are 'out of round prospects off Nigeria, too, with a number of companies currently in discussions. Petroconsultants the there are further opportunities for exploration in the Northern Onshore Fringe Belt, which has an estimated potential of 500 million bbl of reserves. Three OPLs are open.

  10. Quantized Step-up Model for Evaluation of Internship in Teaching of Prospective Science Teachers.

    ERIC Educational Resources Information Center

    Sindhu, R. S.

    2002-01-01

    Describes the quantized step-up model developed for the evaluation purposes of internship in teaching which is an analogous model of the atomic structure. Assesses prospective teachers' abilities in lesson delivery. (YDS)

  11. Evaluating the Effectiveness of College Web Sites for Prospective Students

    ERIC Educational Resources Information Center

    Ford, Wendy G.

    2011-01-01

    College Web sites are often the first structured encounter a student has with a prospective college or university. Outside of serving as a marketing tool (Williams 2000), very little literature exists on the functional purpose of a college's Web site. Almost all college sites show an informational and transactional tool for currently enrolled…

  12. Efficacy of oleuropein against UVB irradiation: preliminary evaluation.

    PubMed

    Perugini, P; Vettor, M; Rona, C; Troisi, L; Villanova, L; Genta, I; Conti, B; Pavanetto, F

    2008-04-01

    Oleuropein, a phenolic compound derived from olive leaves and oil, is known to possess several biological properties, many of which may be attributed to its antioxidant and free radical-scavenging activities. Nevertheless, up to now, the cosmetic activity of this molecule has not been extensively investigated. The aim of this work was to evaluate the cosmetic properties of oleuropein against UVB-induced erythema. To this end, an emulsion and an emulgel containing oleuropein were prepared, applied and evaluated on healthy volunteers who had undergone UVB irradiation to investigate its protective and/or lenitive activity. Protective effect was assayed by application of topical preparations before irradiation and lenitive effect was evaluated after erythema induction. Vitamin E was used as the reference compound. Our study was carried out by using noninvasive techniques to assess specific skin parameters: barrier function, skin colour and microcirculation. Results clearly showed that oleuropein formulations highlighted lenitive efficacy by reducing erythema, transepidermal water loss and blood flow of about 22%, 35% and 30% respectively. The study allowed us to point out the lenitive property of oleuropein, opening the way to further trials to deepen our specific knowledge about this natural molecule, which could be used in association with other active ingredients in cosmetics to repair UV damages.

  13. Increasing Career Self-Efficacy for Women: Evaluating a Group Intervention.

    ERIC Educational Resources Information Center

    Sullivan, Kate Roy; Mahalik, James R.

    2000-01-01

    Evaluates whether women participating in a career group designed to increase career-related self-efficacy would make gains on career decision-making self-efficacy and vocational exploration and commitment compared with women in a control group. Results indicate that women in the treatment group improved on career decision-making self-efficacy and…

  14. An Evaluation of the Self-Efficacy Theory in Agricultural Education

    ERIC Educational Resources Information Center

    McKim, Aaron J.; Velez, Jonathan J.

    2016-01-01

    This research sought to evaluate the use of the self-efficacy theory in agricultural education. A total of 30 studies, published between 1997 and 2013 using self-efficacy as a theoretical foundation were compiled and analyzed. The findings of these studies were compared to expected outcomes identified by the self-efficacy theory, specifically the…

  15. Efficacy of Atomoxetine for the Treatment of ADHD Symptoms in Patients with Pervasive Developmental Disorders: A Prospective, Open-Label Study

    ERIC Educational Resources Information Center

    Fernandez-Jaen, Alberto; Fernandez-Mayoralas, Daniel Martin; Calleja-Perez, Beatriz; Munoz-Jareno, Nuria; Campos Diaz, Maria del Rosario; Lopez-Arribas, Sonia

    2013-01-01

    Objective: Atomoxetine's tolerance and efficacy were studied in 24 patients with pervasive developmental disorder and symptoms of ADHD. Method: Prospective, open-label, 16-week study was performed, using the variables of the Clinical Global Impression Scale and the Conners' Scale, among others. Results: A significant difference was found between…

  16. A prospective randomised trial to compare the efficacy of povidone-iodine 10% and chlorhexidine 2% for skin disinfection

    PubMed Central

    Kulkarni, Atul P; Awode, Rishikesh M

    2013-01-01

    Context: Infectious complications of invasive procedures affect patient outcomes adversely. Choice of antiseptic solution at the time of insertion is one of the major factors affecting their incidence. Aims: This study was undertaken to compare efficacy of chlorhexidine 2% and povidone iodine 10% for skin disinfection prior to placement of epidural and central venous catheters (CVCs). Settings and Design: A prospective randomised trial in the operating rooms of a tertiary referral cancer centre. Methods: Sixty consecutive adult patients undergoing elective oncosurgery requiring placement of epidural and CVCs were enrolled. Paired skin swabs were collected before and after application of the antiseptic solution. The samples were incubated in McConkey's media and blood agar at 35°C for up to 24 h. Any bacterial growth was graded as: <10 colonies - poor growth, 10-50 colonies - moderate growth and >50 colonies as heavy growth. Data on demographics and antibiotic prophylaxis and costs was collected for all patients. Statistical Analysis: Student's t-test and Mann-Whitney tests were used to analyse data, P<0.05 was considered significant. Results: Demographics and antibiotic prophylaxis use was similar in both groups. Before application of antiseptic solution, a variety of micro-organisms were grown from most patients with growth ranging from none-heavy. No organism was grown after application of either antiseptic solution from any patient. Conclusions: We found no differences between 2% chlorhexidine and 10% povidone-iodine for skin disinfection in regard to costs, efficacy or side-effects. PMID:23983286

  17. The Efficacy of Stuttering Measurement Training: Evaluating Two Training Programs

    PubMed Central

    Bainbridge, Lauren A.; Stavros, Candace; Ebrahimian, Mineh; Wang, Yuedong

    2015-01-01

    Purpose Two stuttering measurement training programs currently used for training clinicians were evaluated for their efficacy in improving the accuracy of total stuttering event counting. Method Four groups, each with 12 randomly allocated participants, completed a pretest–posttest design training study. They were evaluated by their counts of stuttering events on eight 3-min audiovisual speech samples from adults and children who stutter. Stuttering judgment training involved use of either the Stuttering Measurement System (SMS), Stuttering Measurement Assessment and Training (SMAAT) programs, or no training. To test for the reliability of any training effect, SMS training was repeated with the 4th group. Results Both SMS-trained groups produced approximately 34% improvement, significantly better than no training or the SMAAT program. The SMAAT program produced a mixed result. Conclusions The SMS program was shown to produce a “medium” effect size improvement in the accuracy of stuttering event counts, and this improvement was almost perfectly replicated in a 2nd group. Half of the SMAAT judges produced a 36% improvement in accuracy, but the other half showed no improvement. Additional studies are needed to demonstrate the durability of the reported improvements, but these positive effects justify the importance of stuttering measurement training. PMID:25629956

  18. Pharmacoeconomic evaluation of new treatments: efficacy versus effectiveness studies?

    PubMed Central

    Bombardier, C; Maetzel, A

    1999-01-01

    The juxtaposition of economic and clinical evaluation raises new issues in the design of clinical trials. Recent pharmacoeconomic guidelines provide some direction, but do not deal with the appropriate timing of economic evaluations in the drug developmental process. Ideally, pharmacoeconomic data should be available at the time of the regulatory and formulary decision making. Current pivotal phase III trials do not provide these data; they are designed to test safety and efficacy (does the drug work under optimal circumstances?) and not to answer questions about the effectiveness of a drug, the more relevant question for economic analysis (does the drug work in usual care?). The use of more "naturalistic" designs for some phase III randomised trials has been suggested. These so called "effectiveness trials" more closely reflect routine clinical practice. They use a more flexible dosage regimen, and a "usual care" instead of a placebo comparator. Patients randomised are more representative of actual practice and outcomes include quality of life and utility measures. They are more suited to provide the data needed to estimate the real benefit of the treatment in actual care. When costs are applied and compared with these benefits, you can estimate the efficiency of allocating resources to this new drug. Increasing the use of effectiveness trials in phase III would decrease the need for economic modelling.

 PMID:10577979

  19. Need of UV protection and evaluation of efficacy of sunscreens.

    PubMed

    Kaur, Anoopinder; Thatai, Purva; Sapra, Bharti

    2014-01-01

    Sun exposure has been coupled with numerous types of acute and chronic reactions in skin, for example, sun burns, photoimmune suppression, photoaging, and skin cancer. In scrutiny of growing understanding of the potentially unfavorable long-term side effects of solar irradiation, there is a universal call for harmless and effective photoprotectants. Photoprotective agents are used for protection against ultraviolet (UV) radiations. In support of best photoprotective measures, now sunscreens are in great demand. Safeguard from UVB is quantified as a minimal erythema dose-based sun protection factor (SPF). UVA protection testing methods include evaluation of persistent pigment darkening (PPD) and critical wavelength. The rationale of this review is to present the contemporary information on the cutaneous pathophysiology of photooxidative stress, to study different UV filters with their UV spectrum and various commercially available sunscreens, with special emphasis on their active ingredients and SPFs. The characterization of different parameters to evaluate the efficacy of sunscreens, for example, SPF, immune suppression factor, photostability, and water resistance, have been described on the basis of findings from different researchers.

  20. Evaluating the impact of seismic prospecting on artisanal shrimp fisheries

    NASA Astrophysics Data System (ADS)

    Andriguetto-Filho, José M.; Ostrensky, Antonio; Pie, Marcio R.; Silva, Ubiratã A.; Boeger, Walter A.

    2005-09-01

    The constant need to discover new hydrocarbon deposits is causing the use of air-guns to become a very widespread method of seismic prospecting. However, there is still disagreement regarding their impact on the marine environment. This uncertainty is particularly severe in the case of shellfish, which account for a substantial share of commercial fisheries and seafood trade in many parts of the world. In this paper we report on the first study to explicitly assess the impact of seismic prospecting on shrimp resources. We measured bottom trawl yields of a nonselective commercial shrimp fishery comprising the Southern white shrimp, Litopenaeus schmitti, the Southern brown shrimp, Farfantepenaeus subtilis, and the Atlantic Seabob, Xyphopenaeus kroyeri (Decapoda: Penaeidae), before and after the use of an array of four synchronized air-guns, each with 635 in 3 of total capacity, 2.000 psi, and peak pressure of 196 dB (re 1 μPa at 1 m). Our results did not detect significant deleterious impact of seismic prospecting on the studied species, suggesting that shrimp stocks are resilient to the disturbance by air-guns under our experimental conditions.

  1. Characterization of mathematics instructional practises for prospective elementary teachers with varying levels of self-efficacy in classroom management and mathematics teaching

    NASA Astrophysics Data System (ADS)

    Lee, Carrie W.; Walkowiak, Temple A.; Nietfeld, John L.

    2017-03-01

    The purpose of this study was to investigate the relationship between prospective teachers' (PTs) instructional practises and their efficacy beliefs in classroom management and mathematics teaching. A sequential, explanatory mixed-methods design was employed. Results from efficacy surveys, implemented with 54 PTs were linked to a sample of teachers' instructional practises during the qualitative phase. In this phase, video-recorded lessons were analysed based on tasks, representations, discourse, and classroom management. Findings indicate that PTs with higher levels of mathematics teaching efficacy taught lessons characterised by tasks of higher cognitive demand, extended student explanations, student-to-student discourse, and explicit connections between representations. Classroom management efficacy seems to bear influence on the utilised grouping structures. These findings support explicit attention to PTs' mathematics teaching and classroom management efficacy throughout teacher preparation and a need for formative feedback to inform development of beliefs about teaching practises.

  2. Characterization of mathematics instructional practises for prospective elementary teachers with varying levels of self-efficacy in classroom management and mathematics teaching

    NASA Astrophysics Data System (ADS)

    Lee, Carrie W.; Walkowiak, Temple A.; Nietfeld, John L.

    2017-01-01

    The purpose of this study was to investigate the relationship between prospective teachers' (PTs) instructional practises and their efficacy beliefs in classroom management and mathematics teaching. A sequential, explanatory mixed-methods design was employed. Results from efficacy surveys, implemented with 54 PTs were linked to a sample of teachers' instructional practises during the qualitative phase. In this phase, video-recorded lessons were analysed based on tasks, representations, discourse, and classroom management. Findings indicate that PTs with higher levels of mathematics teaching efficacy taught lessons characterised by tasks of higher cognitive demand, extended student explanations, student-to-student discourse, and explicit connections between representations. Classroom management efficacy seems to bear influence on the utilised grouping structures. These findings support explicit attention to PTs' mathematics teaching and classroom management efficacy throughout teacher preparation and a need for formative feedback to inform development of beliefs about teaching practises.

  3. Reflections and Future Prospects for Evaluation in Human Resource Development

    ERIC Educational Resources Information Center

    Han, Heeyoung; Boulay, David

    2013-01-01

    Human resource development (HRD) evaluation has often been criticized for its limited function in organizational decision making. This article reviews evaluation studies to uncover the current status of HRD evaluation literature. The authors further discuss general evaluation theories in terms of value, use, and evaluator role to extend the…

  4. Efficacy and Tolerability of Solifenacin 5 mg Fixed Dose in Korean Children with Newly Diagnosed Idiopathic Overactive Bladder: a Multicenter Prospective Study

    PubMed Central

    2017-01-01

    We investigated the efficacy and tolerability of solifenacin 5 mg fixed dose in children with newly diagnosed idiopathic overactive bladder (OAB). A total of 34 children (male/female patients = 16/18) aged under 13 years (mean age: 7.2 ± 2.3; range: 5–12) who were newly diagnosed with OAB from January 2012 to September 2014 were prospectively evaluated with open-label protocol. All patients were treated with solifenacin 5 mg fixed dose once daily for at least 4 weeks. The efficacy and tolerability of solifenacin were evaluated 4, 8, and 12 weeks after the initiation of treatment. The mean voiding frequency during daytime was decreased from 9.4 ± 3.0 to 6.5 ± 2.3 times after the 12-week treatment (P < 0.001). The mean total OAB symptom score (OABSS) decreased from 7.7 ± 4.2 to 3.1 ± 3.1 after the 12-week treatment (P < 0.001). The urgency and urgency urinary incontinence (UUI) domains significantly improved from the 12-week treatment, and complete resolution of urgency occurred in 38.9% of patients and the percentage of children with UUI among urgent patients decreased from 79.4% to 57.1%. According to 3-day voiding diaries, the average bladder capacity increased from 90.4 ± 44.4 to 156.2 ± 67.3 mL (P < 0.001). Drug-induced adverse effects (AEs) were reported in 7 patients (20.6%). Our results indicate that solifenacin 5 mg fixed dose is effective against OAB symptoms, and its tolerability is acceptable without significant AEs in children with OAB. PMID:28049246

  5. Efficacy and Safety Evaluation of a Chlorine Dioxide Solution.

    PubMed

    Ma, Jui-Wen; Huang, Bin-Syuan; Hsu, Chu-Wei; Peng, Chun-Wei; Cheng, Ming-Long; Kao, Jung-Yie; Way, Tzong-Der; Yin, Hao-Chang; Wang, Shan-Shue

    2017-03-22

    In this study, a chlorine dioxide solution (UC-1) composed of chlorine dioxide was produced using an electrolytic method and subsequently purified using a membrane. UC-1 was determined to contain 2000 ppm of gaseous chlorine dioxide in water. The efficacy and safety of UC-1 were evaluated. The antimicrobial activity was more than 98.2% reduction when UC-1 concentrations were 5 and 20 ppm for bacteria and fungi, respectively. The half maximal inhibitory concentrations (IC50) of H1N1, influenza virus B/TW/71718/04, and EV71 were 84.65 ± 0.64, 95.91 ± 11.61, and 46.39 ± 1.97 ppm, respectively. A 3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) test revealed that the cell viability of mouse lung fibroblast L929 cells was 93.7% at a 200 ppm UC-1 concentration that is over that anticipated in routine use. Moreover, 50 ppm UC-1 showed no significant symptoms in a rabbit ocular irritation test. In an inhalation toxicity test, treatment with 20 ppm UC-1 for 24 h showed no abnormality and no mortality in clinical symptoms and normal functioning of the lung and other organs. A ClO₂ concentration of up to 40 ppm in drinking water did not show any toxicity in a subchronic oral toxicity test. Herein, UC-1 showed favorable disinfection activity and a higher safety profile tendency than in previous reports.

  6. Evaluating the Potential Efficacy of Invasive Lionfish (Pterois volitans) Removals

    PubMed Central

    Barbour, Andrew B.; Allen, Michael S.; Frazer, Thomas K.; Sherman, Krista D.

    2011-01-01

    The lionfish, Pterois volitans (Linnaeus) and Pterois miles (Bennett), invasion of the Western Atlantic Ocean, Caribbean Sea and Gulf of Mexico has the potential to alter aquatic communities and represents a legitimate ecological concern. Several local removal programs have been initiated to control this invasion, but it is not known whether removal efforts can substantially reduce lionfish numbers to ameliorate these concerns. We used an age-structured population model to evaluate the potential efficacy of lionfish removal programs and identified critical data gaps for future studies. We used high and low estimates for uncertain parameters including: length at 50% vulnerability to harvest (Lvul), instantaneous natural mortality (M), and the Goodyear compensation ratio (CR). The model predicted an annual exploitation rate between 35 and 65% would be required to cause recruitment overfishing on lionfish populations for our baseline parameter estimates for M and CR (0.5 and 15). Lionfish quickly recovered from high removal rates, reaching 90% of unfished biomass six years after a 50-year simulated removal program. Quantifying lionfish natural mortality and the size-selective vulnerability to harvest are the most important knowledge gaps for future research. We suggest complete eradication of lionfish through fishing is unlikely, and substantial reduction of adult abundance will require a long-term commitment and may be feasible only in small, localized areas where annual exploitation can be intense over multiple consecutive years. PMID:21572951

  7. Evaluating the potential efficacy of invasive lionfish (Pterois volitans) removals.

    PubMed

    Barbour, Andrew B; Allen, Micheal S; Allen, Michael S; Frazer, Thomas K; Sherman, Krista D

    2011-05-10

    The lionfish, Pterois volitans (Linnaeus) and Pterois miles (Bennett), invasion of the Western Atlantic Ocean, Caribbean Sea and Gulf of Mexico has the potential to alter aquatic communities and represents a legitimate ecological concern. Several local removal programs have been initiated to control this invasion, but it is not known whether removal efforts can substantially reduce lionfish numbers to ameliorate these concerns. We used an age-structured population model to evaluate the potential efficacy of lionfish removal programs and identified critical data gaps for future studies. We used high and low estimates for uncertain parameters including: length at 50% vulnerability to harvest (L(vul)), instantaneous natural mortality (M), and the Goodyear compensation ratio (CR). The model predicted an annual exploitation rate between 35 and 65% would be required to cause recruitment overfishing on lionfish populations for our baseline parameter estimates for M and CR (0.5 and 15). Lionfish quickly recovered from high removal rates, reaching 90% of unfished biomass six years after a 50-year simulated removal program. Quantifying lionfish natural mortality and the size-selective vulnerability to harvest are the most important knowledge gaps for future research. We suggest complete eradication of lionfish through fishing is unlikely, and substantial reduction of adult abundance will require a long-term commitment and may be feasible only in small, localized areas where annual exploitation can be intense over multiple consecutive years.

  8. Reinforcement Magnitude: An Evaluation of Preference and Reinforcer Efficacy

    ERIC Educational Resources Information Center

    Trosclair-Lasserre, Nicole M.; Lerman, Dorothea C.; Call, Nathan A.; Addison, Laura R.; Kodak, Tiffany

    2008-01-01

    Consideration of reinforcer magnitude may be important for maximizing the efficacy of treatment for problem behavior. Nonetheless, relatively little is known about children's preferences for different magnitudes of social reinforcement or the extent to which preference is related to differences in reinforcer efficacy. The purpose of the current…

  9. Efficacy of Epley's Maneuver in Treating BPPV Patients: A Prospective Observational Study

    PubMed Central

    Gaur, Sushil; Awasthi, Sanjeev Kumar; Bhadouriya, Sunil Kumar Singh; Saxena, Rohit; Pathak, Vivek Kumar; Bisht, Mamta

    2015-01-01

    Vertigo and balance disorders are among the most common symptoms encountered in patients who visit ENT outpatient department. This is associated with risk of falling and is compounded in elderly persons with other neurologic deficits and chronic medical problems. BPPV is the most common cause of peripheral vertigo. BPPV is a common vestibular disorder leading to significant morbidity, psychosocial impact, and medical costs. The objective of Epley's maneuver, which is noninvasive, inexpensive, and easily administered, is to move the canaliths out of the canal to the utricle where they no longer affect the canal dynamics. Our study aims to analyze the response to Epley's maneuver in a series of patients with posterior canal BPPV and compares the results with those treated exclusively by medical management alone. Even though many studies have been conducted to prove the efficacy of this maneuver, this study reinforces the validity of Epley's maneuver by comparison with the medical management. PMID:26495002

  10. Clinical Observed Performance Evaluation: A Prospective Study in Final Year Students of Surgery

    ERIC Educational Resources Information Center

    Markey, G. C.; Browne, K.; Hunter, K.; Hill, A. D.

    2011-01-01

    We report a prospective study of clinical observed performance evaluation (COPE) for 197 medical students in the pre-qualification year of clinical education. Psychometric quality was the main endpoint. Students were assessed in groups of 5 in 40-min patient encounters, with each student the focus of evaluation for 8 min. Each student had a series…

  11. Checklists for the Evaluation of Educational Software: Critical Review and Prospects.

    ERIC Educational Resources Information Center

    Tergan, Sigmar-Olaf

    1998-01-01

    Reviews strengths and weaknesses of check lists for the evaluation of computer software and outlines consequences for their practical application. Suggests an approach based on an instructional design model and a comprehensive framework to cope with problems of validity and predictive power of software evaluation. Discusses prospects of the…

  12. Predictors of opioid efficacy in patients with chronic pain: A prospective multicenter observational cohort study

    PubMed Central

    Olesen, Anne E.; Gram, Mikkel; Jonsson, Torsten; Kamp-Jensen, Michael; Andresen, Trine; Nielsen, Christian; Pozlep, Gorazd; Pfeiffer-Jensen, Mogens; Morlion, Bart; Drewes, Asbjørn M.

    2017-01-01

    Opioids are increasingly used for treatment of chronic pain. However, they are only effective in a subset of patients and have multiple side effects. Thus, studies using biomarkers for response are highly warranted. The current study prospectively examined 63 opioid-naïve patients initiating opioid use for diverse types of chronic pain at five European centers. Quantitative sensory testing, electroencephalography (EEG) recordings, and assessment of pain catastrophizing were performed prior to treatment. The co-primary outcomes were change from baseline in ratings of chronic pain and quality of life after 14 days of opioid treatment. Secondary outcomes included patient’s global impression of clinical change and side effects. Logistic regression models adjusted for age and sex were used to identify biomarkers predictive for successful treatment, defined as at least a 30% reduction in average pain intensity or an improvement in quality of life of at least 10 scale points. Fifty-nine patients (94%) completed the study. The mean age was 55 ± 16 years and 69% were females. Pain reduction was predicted by cold pain intensity (OR: 0.69; P = 0.01), pain catastrophizing (OR: 0.82; P = 0.03), relative delta (OR: 0.76; P = 0.03) and beta EEG activity (OR: 1.18; P = 0.04) induced by experimental cold pain. None of the study variables were related to improvement in quality of life. For the first time, individual pain processing characteristics have been linked to opioid response in a mixed chronic pain population. This has the potential to personalize treatment of chronic pain and restrict opioid use to patients with high likelihood for response. PMID:28158269

  13. Clinical Evaluation of Efficacy of CIA and CNA Intrusion Arches

    PubMed Central

    Vora, Sambhav; Pandey, Vinisha

    2015-01-01

    Background and Objectives Excessive overbite is one of the most common problems that confront the orthodontist. Deep bite can be due to infraocclusion of posterior teeth, supraocclusion of anterior teeth or a combination of the two. Correction of same can be carried out by extrusion of molars, intrusion of incisors or by a combination of both respectively. Various intrusion arches are recommended for correcting deep bite by true intrusion of anterior teeth, Utility arches, Segmental arch, Connecticut Intrusion Arch (CIA) and Connecticut New Arch (CNA). The purpose of this study was to evaluate clinical efficacy of CIA and CNA intrusion arches. Materials and Methods Tracings recorded from pre and post-treatment lateral cephalograms of 25 patients treated by CIA (Group I) and another 25 patients treated by CNA (Group II) intrusion arches in deep bite cases after four months of treatment were analysed and findings were recorded. Statistical Analysis Paired t-test was used to compare pre and post-treatment changes within Groups I and II and unpaired t-test was used to compare treatment changes between Group I and Group II. A P-value of < 0.05 was set for statistical significance. Results Findings of this study demonstrate that an average of 1mm of intrusion takes place with CIA intrusion arch and 1.3mm with CNA intrusion arch in a period of 4 months. Both intrusion arches do not affect the position of molar in vertical or anteroposterior plane. Interpretation & Conclusion Both CIA and CNA intrusion arches are effective in bringing about intrusion of lower incisors. PMID:26501008

  14. Efficacy and Safety Evaluation of a Chlorine Dioxide Solution

    PubMed Central

    Ma, Jui-Wen; Huang, Bin-Syuan; Hsu, Chu-Wei; Peng, Chun-Wei; Cheng, Ming-Long; Kao, Jung-Yie; Way, Tzong-Der; Yin, Hao-Chang; Wang, Shan-Shue

    2017-01-01

    In this study, a chlorine dioxide solution (UC-1) composed of chlorine dioxide was produced using an electrolytic method and subsequently purified using a membrane. UC-1 was determined to contain 2000 ppm of gaseous chlorine dioxide in water. The efficacy and safety of UC-1 were evaluated. The antimicrobial activity was more than 98.2% reduction when UC-1 concentrations were 5 and 20 ppm for bacteria and fungi, respectively. The half maximal inhibitory concentrations (IC50) of H1N1, influenza virus B/TW/71718/04, and EV71 were 84.65 ± 0.64, 95.91 ± 11.61, and 46.39 ± 1.97 ppm, respectively. A 3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) test revealed that the cell viability of mouse lung fibroblast L929 cells was 93.7% at a 200 ppm UC-1 concentration that is over that anticipated in routine use. Moreover, 50 ppm UC-1 showed no significant symptoms in a rabbit ocular irritation test. In an inhalation toxicity test, treatment with 20 ppm UC-1 for 24 h showed no abnormality and no mortality in clinical symptoms and normal functioning of the lung and other organs. A ClO2 concentration of up to 40 ppm in drinking water did not show any toxicity in a subchronic oral toxicity test. Herein, UC-1 showed favorable disinfection activity and a higher safety profile tendency than in previous reports. PMID:28327506

  15. Efficacy and safety of telbivudine treatment: an open-label, prospective study in pregnant women for the prevention of perinatal transmission of hepatitis B virus infection.

    PubMed

    Han, G-R; Jiang, H-X; Yue, X; Ding, Y; Wang, C-M; Wang, G-J; Yang, Y-F

    2015-09-01

    We evaluated the efficacy and safety of telbivudine (LdT, 600 mg/day) vs control patients (no treatment) in decreasing vertical transmission of HBV, in HBeAg-positive mothers (HBVDNA >6log(10) copies/mL). HBeAg-positive pregnant women either in the second or third trimester were recruited in a prospective, case-control, open-label study, at the Second Affiliated Hospital of the Southeast University, China (February 2008-December 2010). Efficacy (month 7: HBVDNA (+), HBsAg (+) infants) in either the overall group or the treated group and control group was analysed using student's t-test. Infants were followed for at least 1 year. 362 women received LdT (second trimester n = 257; third trimester n = 105) and 92 were untreated. Before delivery, the mean maternal HBVDNA was 2.73, 2.47, 3.34 and 7.94 log10 copies/mL in the overall, second and third trimester treated and control groups, respectively (P < 0.001). At birth, 11.8% of babies overall (43/365), 13.5% (35/259) of those treated in the second trimester, 7.5% of those treated in the third trimester (8/106) and 20.7% (19/92) of untreated infants were HBsAg positive. At month 7, none of the LdT-treated infant had detectable HBVDNA, while eight infants from control mothers were HBsAg positive. Vertical transmission was 0% in LdT treated and 9.3% (8/86) in the control groups (P < 0.001). No difference in the vertical transmission rate was found in mothers treated in the second or third trimester. LdT treatment was safe for mothers and infants, and no congenital deformities were reported.

  16. Prospective, open-label, uncontrolled pilot study to study safety and efficacy of sildenafil in systemic sclerosis-related pulmonary artery hypertension and cutaneous vascular complications.

    PubMed

    Kumar, Uma; Sankalp, Gokhale; Gokhle, Sankalp S; Sreenivas, V; Kaur, Satbir; Misra, Durgaprasanna

    2013-04-01

    Pulmonary artery hypertension (PAH) remains the leading cause of morbidity and mortality in systemic sclerosis, while Raynaud's phenomenon and digital ulcers significantly add to the morbidity in systemic sclerosis (SSc). This study was undertaken to evaluate the role of sildenafil in PAH, Raynaud's phenomenon, and digital ulcers in systemic sclerosis patients. A prospective, open-label, uncontrolled pilot study was done at a tertiary care centre in India to study the safety and efficacy of oral sildenafil in PAH, Raynaud's phenomenon, digital infarcts, and ulcers in SSc. Seventeen patients fulfilling ACR classification criteria for scleroderma and having PAH were recruited. Six-minute walk test, WHO class of dyspnoea, severity of Raynaud's phenomenon, and 2D ECHO were performed in all the study subjects at baseline and at 3 months post-treatment. All patients were treated with oral sildenafil 25 mg three times a day for a period of 3 months. The pre- and post-treatment values of mean pulmonary artery pressure (PAP), 6-min walk test, WHO class of dyspnoea, and severity of Raynaud's phenomenon were compared to look for any significant change. Sixteen patients who completed 3-month follow-up had shown statistically significant improvement in 6-min walk test, WHO class of dyspnoea, severity of Raynaud's phenomenon, and mPAP. Also, there was no occurrence of new digital infarcts or ulcers, and existing ulcers showed signs of healing. Sildenafil is highly efficacious cheaper and safe alternative to other available therapies for SSc-associated PAH, Raynaud's phenomenon, and digital infarcts/ulcers.

  17. Teaching Evaluation of Higher Education Institutions: Retrospect and Prospect

    ERIC Educational Resources Information Center

    Siping, Gao

    2009-01-01

    China started up pilot projects for the evaluation of teaching work at regular higher education institutions (HEIs) in 1994, and, beginning in 2003, the Ministry of Education (MOE) formally set up a system of cyclical teaching evaluation. Among the 592 undergraduate colleges and universities that were listed in the plan for the first round of…

  18. Safety and efficacy of the modified peroral endoscopic myotomy with shorter myotomy for achalasia patients: a prospective study.

    PubMed

    Wang, J; Tan, N; Xiao, Y; Chen, J; Chen, B; Ma, Z; Zhang, D; Chen, M; Cui, Y

    2015-01-01

    Peroral endoscopic myotomy (POEM) has been developed as a minimally invasive endoscopic treatment for achalasia for years. However, the optimal length of submucosal tunnel and myotomy of muscle bundles during procedure of POEM has not yet been determined, so we aim to assess safety and efficacy of modified POEM with shorter myotomy of muscle bundles in achalasia patients. Consecutive achalasia patients had been performed modified POEM with shorter myotomy, and assessed by symptoms, high-resolution manometry, and barium swallow examinations before and 3 months after POEM for safety and efficacy evaluation. Modified POEM with shorter submucosal tunnel (mean length 6.8 cm) and endoscopic myotomy of muscle bundles (total mean length 5.4 cm) were completed in 46 consecutive achalasia patients. During the 3-month follow up in all cases, significant improvement of symptoms (a significant drop in the Eckardt score 8.4 ± 3.2 vs. 2.7 ± 1.9; P < 0.001), decreased lower esophageal sphincter pressure (39.4 ± 10.1 vs. 24.4 ± 9.1 mmHg; P < 0.001) and integrated relaxation pressure (38.6 ± 10.4 vs. 25.7 ± 9.6 mmHg; P < 0.01), and a drop in height of esophagus barium-contrast column (5.4 ± 3.1 vs. 2.6 ± 1.8 cm; P < 0.001) were observed. The frequencies of adverse events were lower in those under endotracheal anesthesia and CO2 insufflations compared with intravenous anesthesia and air insufflations. Only three patients were found to have gastroesophageal reflux disease on follow up. Modified POEM with shorter myotomy under endotracheal anesthesia and CO2 insufflations shows its good safety and excellent short-term efficacy in the treatment of achalasia. But further studies are warranted to assess the long-term efficacy.

  19. Efficacy of Traditional Chinese Medicine in Xerostomia and Quality of Life during Radiotherapy for Head and Neck Cancer: A Prospective Pilot Study

    PubMed Central

    Tsang, Ngan-Ming; Lin, Jr-Rung; Lin, Yung-Chang; Chen, Hsing-Yu; Yang, Ching-Wei

    2016-01-01

    Xerostomia is one of the most common acute and late complications of radiotherapy for head and neck cancer, and it affects quality of life. We conducted a prospective study to evaluate the efficacy of traditional Chinese medicine (TCM) in toxicities and quality of life during radiotherapy. Head and neck cancer patients who were scheduled for radiotherapy were checked for inclusion/exclusion criteria before enrollment. Patients in the study group (inpatients) were hospitalized in a Chinese medicine ward and received concomitant TCM intervention during radiotherapy, while those in the control group (outpatients) received only conventional cancer treatments at the Western outpatient department. The primary end point was amelioration of postradiotherapy side effects. The secondary end points were quality of life during the cancer therapy and occurrence of adverse events following the TCM treatments. Thirty inpatients and 50 outpatients completed the study. Compared to the control group, those in the TCM group had decreased severity of xerostomia. There was no treatment-related impairment of renal or hepatic function among TCM group. Although better outcomes of social contact, dyspnea, physical and emotional function, and financial problems were found in the TCM group, we need further confirmation about the impact of hospitalization itself on these results. PMID:27642359

  20. Dimethyl sulfoxide with lignocaine versus eutectic mixture of local anesthetics: prospective randomized study to compare the efficacy of cutaneous anesthesia in shock wave lithotripsy.

    PubMed

    Kumar, Santosh; Kumar, Sunil; Ganesamoni, Raguram; Mandal, Arup K; Prasad, Seema; Singh, Shrawan K

    2011-06-01

    The objective of the study was to compare the efficacy of dimethyl sulfoxide (DMSO) mixed with lignocaine and eutectic mixture of local anesthetics (EMLA) cream as topically applied surface anesthetics in relieving pain during shock wave lithotripsy (SWL) in a prospective randomized study. Of the 160 patients, 80 patients received DMSO with lignocaine and 80 patients received EMLA cream, applied to the skin of the flank at the area of entry of shock waves. SWL was done with Seimens lithostar multiline lithotripter. The pain during the procedure was assessed using visual analog and verbal rating scores. The mean visual analog scale scores for the two groups were 3.03 for DMSO group and 4.43 for EMLA group. The difference of pain score on visual analog scale was statistically significant (p < 0.05). Similarly, the pain scores as rated on the verbal rating scale were also evaluated; the mean score on verbal rating scale were 2.34 for DMSO group and 3.00 for the EMLA group. The difference between the pain score on verbal rating scale was also found to be statistically significant (p < 0.05). Our study showed that DMSO with lignocaine is a better local anesthetic agent for SWL than EMLA cream. The stone fragmentation and clearance rates are also better in the DMSO group.

  1. Antianginal Efficacy and Tolerability of Ranolazine as an Add-on Drug to Concomitant Medications Primarily Metoprolol in Chronic Stable Angina Patients: A Prospective, Open-Label Study

    PubMed Central

    Khot, Anant Mahaveer; Anuradha, H. V.; Prakash, V. S.; Shivamurathy, M. C.

    2017-01-01

    Objective: To evaluate the efficacy and tolerability of ranolazine as an add-on drug in chronic stable angina patients and the impact of ranolazine on the quality of life in chronic stable angina patients receiving other antianginal medications. Materials and Methods: It was a prospective, open-label, hospital-based study involving 144 patients with chronic stable angina. First group received either metoprolol 12.5 or 25 mg/day or other antianginal medications; if the symptoms persist, the dose of metoprolol was increased to 50 mg/day, and to the second group, ranolazine 500 mg BD or 1 g OD was added along with metoprolol or others if the anginal attacks were not subsiding. The patients were followed up to 6 months with electrocardiography, treadmill test, and quality of life questionnaire. Adverse events were recorded at each visit during the study. Results: There was a statistically significant reduction in weekly anginal frequency (P < 0.001) and improvement in an exercise tolerance in both the groups, but more in the ranolazine group. Adverse events reported were mild, infrequent. Conclusion: Ranolazine is could be used as an add-on drug in chronic angina patients not improved with metoprolol or antianginal medications.

  2. Laparoscopic inguinal hernia repair: a prospective evaluation at Eastern Nepal

    PubMed Central

    Shakya, Vikal Chandra; Sood, Shasank; Bhattarai, Bal Krishna; Agrawal, Chandra Shekhar; Adhikary, Shailesh

    2014-01-01

    Introduction Inguinal hernias have been treated traditionally with open methods of herniorrhaphy or hernioplasty. But the trends have changed in the last decade with the introduction of minimal access surgery. Methods This study was a prospective descriptive study in patients presenting to Surgery Department of B. P. Koirala Institute of Health Sciences, Dharan, Nepal with reducible inguinal hernias from January 2011 to June 2012. All patients >18 years of age presenting with inguinal hernias were given the choice of laparoscopic repair or open repair. Those who opted for laparoscopic repair were included in the study. Results There were 50 patients, age ranged from 18 to 71 years with 34 being median age at presentation. In 41 patients, totally extraperitoneal repair was attempted. Of these, 2 (4%) repairs were converted to transabdominal repair and 2 to open mesh repair (4%). In 9 patients, transabdominal repair was done. The median total hospital stay was 4 days (range 3-32 days), the mean postoperative stay was 3.38±3.14 days (range 2-23 days), average time taken for full ambulation postoperatively was 2.05±1.39 days (range 1-10 days), and median time taken to return for normal activity was 5 days (range 2-50 days). One patient developed recurrence (2%). None of the patients who had laparoscopic repair completed complained of neuralgias in the follow-up. Conclusion Laparoscopic repair of inguinal hernias could be contemplated safely both via totally extra peritoneal as well as transperitoneal route even in our setup of a developing country with modifications. PMID:25170385

  3. Regression Discontinuity in Prospective Evaluations: The Case of the FFVP Evaluation

    ERIC Educational Resources Information Center

    Klerman, Jacob Alex; Olsho, Lauren E. W.; Bartlett, Susan

    2015-01-01

    While regression discontinuity has usually been applied retrospectively to secondary data, it is even more attractive when applied prospectively. In a prospective design, data collection can be focused on cases near the discontinuity, thereby improving internal validity and substantially increasing precision. Furthermore, such prospective…

  4. The development and validation of the Self-Efficacy Beliefs about Equitable Science Teaching and learning instrument for prospective elementary teachers

    NASA Astrophysics Data System (ADS)

    Ritter, Jennifer M.

    1999-12-01

    The purpose of this study was to develop, validate and establish the reliability of an instrument to assess the self-efficacy beliefs of prospective elementary teachers with regards to science teaching and learning for diverse learners. The study used Bandura's theoretical framework, in that the instrument would use the self-efficacy construct to explore the beliefs of prospective elementary science teachers with regards to science teaching and learning to diverse learners: specifically the two dimensions of self-efficacy beliefs defined by Bandura (1977): personal self-efficacy and outcome expectancy. A seven step plan was designed and followed in the process of developing the instrument, which was titled the Self-Efficacy Beliefs about Equitable Science Teaching or SEBEST. Diverse learners as recognized by Science for All Americans (1989) are "those who in the past who have largely been bypassed in science and mathematics education: ethnic and language minorities and girls" (p. xviii). That definition was extended by this researcher to include children from low socioeconomic backgrounds based on the research by Gomez and Tabachnick (1992). The SEBEST was administered to 226 prospective elementary teachers at The Pennsylvania State University. Using the results from factor analyses, Coefficient Alpha, and Chi-Square a 34 item instrument was found to achieve the greatest balance across the construct validity, reliability and item balance with the content matrix. The 34 item SEBEST was found to load purely on four factors across the content matrix thus providing evidence construct validity. The Coefficient Alpha reliability for the 34 item SEBEST was .90 and .82 for the PSE sub-scale and .78 for the OE sub-scale. A Chi-Square test (X2 = 2.7 1, df = 7, p > .05) was used to confirm that the 34 items were balanced across the Personal Self-Efficacy/Outcome Expectancy and Ethnicity/LanguageMinority/Gender Socioeconomic Status/dimensions of the content matrix. Based on

  5. Retrospective and prospective evaluation of the Carbapenem inactivation method for the detection of carbapenemase-producing Enterobacteriaceae

    PubMed Central

    Gauthier, Lauraine; Dortet, Laurent; Naas, Thierry

    2017-01-01

    Background There is an urgent need for accurate and rapid diagnostic tests to identify carbapenemase producing enterobacteria (CPE). Here, we have evaluated the Carbapenem Inactivation Method (CIM) test to detect CPEs from cultured colonies. Methods A total of 256 enterobacterial isolates were used to evaluate the performance of the CIM in comparison to Carba NP test and molecular detection used a reference method. Ninety three well-characterized isolates (including 29 non-CPE and 63 CPEs of worldwide origin) with decreased susceptibility to at least one carbapenem were used to (i) evaluate the efficacy of CIM test and (ii) to compare it to the Carba NP test. We also tested different carbapenems to determine the best substrate for this test. Finally, the CIM test was then evaluated prospectively against 164 isolates referred to the French National Reference Center (NRC) for Antimicrobial Resistance from may 2016 to july 2016. Results Based on the results of this retrospective study, sensitivity and specificity of the CIM and the Carba NP test were 92.1% and 100%, respectively. We demonstrated that the meropenem was the best substrate to perform the CIM test since sensitivity and specificity were 81.1% and 100% using ertapenem disk, and 100% and 65,6% using imipenem disk, and respectively. Taking in account the results of retrospective and prospective studies, CIM and Carba NP tests have similar sensitivity, specificity, positive predictive value and negative predictive values being 96.3%, 98.9%, 99.0% and 98.4% for the CIM test versus 96.9%, 100%, 100% and 100% for the Carba NP test. Conclusions Our results confirm that the CIM test may be a useful tool for the reliable confirmation of carbapenemase-activity in enterobacterial isolates, especially in clinical microbiological laboratories with limited resources, no trained personnel, and no specialized equipment. PMID:28158310

  6. Forecasting Emergency Department Crowding: A Prospective, Real-time Evaluation

    PubMed Central

    Hoot, Nathan R.; LeBlanc, Larry J.; Jones, Ian; Levin, Scott R.; Zhou, Chuan; Gadd, Cynthia S.; Aronsky, Dominik

    2009-01-01

    Objective Emergency department crowding threatens quality and access to health care, and a method of accurately forecasting near-future crowding should enable novel ways to alleviate the problem. The authors sought to implement and validate the previously developed ForecastED discrete event simulation for real-time forecasting of emergency department crowding. Design and Measurements The authors conducted a prospective observational study during a three-month period (5/1/07–8/1/07) in the adult emergency department of a tertiary care medical center. The authors connected the forecasting tool to existing information systems to obtain real-time forecasts of operational data, updated every 10 minutes. The outcome measures included the emergency department waiting count, waiting time, occupancy level, length of stay, boarding count, boarding time, and ambulance diversion; each forecast 2, 4, 6, and 8 hours into the future. Results The authors obtained crowding forecasts at 13,239 10-minute intervals, out of 13,248 possible (99.9%). The R2 values for predicting operational data 8 hours into the future, with 95% confidence intervals, were 0.27 (0.26, 0.29) for waiting count, 0.11 (0.10, 0.12) for waiting time, 0.57 (0.55, 0.58) for occupancy level, 0.69 (0.68, 0.70) for length of stay, 0.61 (0.59, 0.62) for boarding count, and 0.53 (0.51, 0.54) for boarding time. The area under the receiver operating characteristic curve for predicting ambulance diversion 8 hours into the future, with 95% confidence intervals, was 0.85 (0.84, 0.86). Conclusions The ForecastED tool provides accurate forecasts of several input, throughput, and output measures of crowding up to 8 hours into the future. The real-time deployment of the system should be feasible at other emergency departments that have six patient-level variables available through information systems. PMID:19261948

  7. Clinical efficacy of certain Unani herbs in knee osteoarthritis: A pretest and post-test evaluation study

    PubMed Central

    Tarannum, Asfia; Sultana, Arshiya; Ur Rahman, Khaleeq

    2016-01-01

    Objectives: This study was conducted to evaluate the efficacy of preparations of certain Unani herbs on Lequesne Algo-Functional Index of knee osteoarthritis (OA). Materials and Methods: A prospective, pre- and post test evaluation study was conducted on 20 diagnosed patients of OA recruited from the Nizamia General Hospital, Hyderabad. Internally, a combination (formula) of Unani herbs was administered, which was as follows: 3.5 g powder of Asarun (2 g), Tukhme karafs (2 g), and Filfil daraz (3 g) was administered internally twice daily. Externally, the concoction of Gule baboona (20 g) and Gule tesu (40 g) made in 1 l water was poured over the affected knee, daily once for 40 days. The primary outcome was to assess the efficacy of Unani test drugs with the modified Lequesne Algo-Functional Index for knee OA. Results: The mean percentage reduction of Lequesne Algo-Functional Index score was 71.09%. The mean and standard deviation was 10.55 (1.70) and 3.05 (2.30) before treatment and after treatment, respectively. The pre- and post test evaluation showed reduction in Lequesne Algo-Functional Index score (P < 0.0001). Conclusion: In this study, the Unani treatment module was found to be effective in reducing the severity of disease in patients with osteoarthritis of knees. PMID:27621521

  8. Evaluation of the Efficacy of Methyl Bromide in the ...

    EPA Pesticide Factsheets

    Journal Article The objective of this article is to determine the required conditions for the effective inactivation of Bacillus anthracis (B.a.) spores on materials using methyl bromide (MeBr) and to obtain comparative efficacy data with three avirulent microorganisms, to assess their potential as surrogates for B.a. Ames.

  9. Development of a Questionnaire To Evaluate Fox Valley Technical College's Marketing Communications with Prospective Student Inquiries.

    ERIC Educational Resources Information Center

    May, Susan A.

    A questionnaire was developed to evaluate the effectiveness of Fox Valley Technical College's (FVTC's) marketing communications with prospective students. The literature on customer service, marketing communications, and institutional image was reviewed, and 17 construct criteria and 7 content criteria were developed as the framework for the…

  10. Development of a Scale for Evaluating the Pedagogical Formation Program Implemented with Turkish Prospective Teachers

    ERIC Educational Resources Information Center

    Adiguzel, Oktay Cem

    2015-01-01

    The current study aims to develop a scale to evaluate the Pedagogical Formation Program implemented at a Turkish state university. Participants were 221 prospective teachers enrolled in the Pedagogical Formation Program in the 2010-2011 academic year. Exploratory factor analysis (EFA) was conducted on the scale items which revealed four factors…

  11. Pre-Service Teachers' Retrospective and Prospective Evaluations: Program, Self, and Teaching Profession

    ERIC Educational Resources Information Center

    Ulusoy, Mustafa

    2015-01-01

    This study aimed to investigate teacher candidates' retrospective and prospective evaluations about the classroom teacher education program, self, and the teaching profession. Observations, interviews, focus group interviews, and surveys were used to collect data from the 240 subjects. Teacher candidates believed that the teaching profession is…

  12. Efficacy and safety of moxifloxacin in acute exacerbations of chronic bronchitis: a prospective, multicenter, observational study (AVANTI)

    PubMed Central

    2013-01-01

    Background Acute exacerbations of chronic bronchitis (AECB), including chronic obstructive pulmonary disease (AECOPD), represent a substantial patient burden. Few data exist on outpatient antibiotic management for AECB/AECOPD in Eastern/South Eastern Europe, in particular on the use of moxifloxacin (Avelox®), although moxifloxacin is widely approved in this region based on evidence from international clinical studies. Methods AVANTI (AVelox® in Acute Exacerbations of chroNic bronchiTIs) was a prospective, observational study conducted in eight Eastern European countries in patients > 35 years with AECB/AECOPD to whom moxifloxacin was prescribed. In addition to safety and efficacy outcomes, data on risk factors and the impact of exacerbation on daily life were collected. Results In the efficacy population (N = 2536), chronic bronchitis had been prevalent for > 10 years in 31.4% of patients and 66.0% of patients had concomitant COPD. Almost half the patients had never smoked, in contrast to data from Western Europe and the USA, where only one-quarter of COPD patients are non-smokers. The mean number of exacerbations in the last 12 months was 2.7 and 26.3% of patients had been hospitalized at least once for exacerbation. Physician compliance with the recommended moxifloxacin dose (400 mg once daily) was 99.6%. The mean duration of moxifloxacin therapy for the current exacerbation (Anthonisen type I or II in 83.1%; predominantly type I) was 6.4 ± 1.9 days. Symptom improvement was reported after a mean of 3.4 ± 1.4 days. After 5 days, 93.2% of patients reported improvement and, in total, 93.5% of patients were symptom-free after 10 days. In the safety population (N = 2672), 57 (2.3%) patients had treatment-emergent adverse events (TEAEs) and 4 (0.15%) had serious TEAEs; no deaths occurred. These results are in line with the known safety profile of moxifloxacin. Conclusions A significant number of patients in this observational study had risk

  13. Efficacy and safety of deep transcranial magnetic stimulation for major depression: a prospective multicenter randomized controlled trial

    PubMed Central

    Levkovitz, Yechiel; Isserles, Moshe; Padberg, Frank; Lisanby, Sarah H; Bystritsky, Alexander; Xia, Guohua; Tendler, Aron; Daskalakis, Zafiris J; Winston, Jaron L; Dannon, Pinhas; Hafez, Hisham M; Reti, Irving M; Morales, Oscar G; Schlaepfer, Thomas E; Hollander, Eric; Berman, Joshua A; Husain, Mustafa M; Sofer, Uzi; Stein, Ahava; Adler, Shmulik; Deutsch, Lisa; Deutsch, Frederic; Roth, Yiftach; George, Mark S; Zangen, Abraham

    2015-01-01

    Major depressive disorder (MDD) is a prevalent and disabling condition, and many patients do not respond to available treatments. Deep transcranial magnetic stimulation (dTMS) is a new technology allowing non-surgical stimulation of relatively deep brain areas. This is the first double-blind randomized controlled multicenter study evaluating the efficacy and safety of dTMS in MDD. We recruited 212 MDD outpatients, aged 22–68 years, who had either failed one to four antidepressant trials or not tolerated at least two antidepressant treatments during the current episode. They were randomly assigned to monotherapy with active or sham dTMS. Twenty sessions of dTMS (18 Hz over the prefrontal cortex) were applied during 4 weeks acutely, and then biweekly for 12 weeks. Primary and secondary efficacy endpoints were the change in the Hamilton Depression Rating Scale (HDRS-21) score and response/remission rates at week 5, respectively. dTMS induced a 6.39 point improvement in HDRS-21 scores, while a 3.28 point improvement was observed in the sham group (p+0.008), resulting in a 0.76 effect size. Response and remission rates were higher in the dTMS than in the sham group (response: 38.4 vs. 21.4%, p+0.013; remission: 32.6 vs. 14.6%, p+0.005). These differences between active and sham treatment were stable during the 12-week maintenance phase. dTMS was associated with few and minor side effects apart from one seizure in a patient where a protocol violation occurred. These results suggest that dTMS constitutes a novel intervention in MDD, which is efficacious and safe in patients not responding to antidepressant medications, and whose effect remains stable over 3 months of maintenance treatment. PMID:25655160

  14. Guidance for the Efficacy Evaluation of Products with Sporicidal Claims Against Clostridium difficile (June 2014)

    EPA Pesticide Factsheets

    This document provides an update to the Agency’s interim guidance for the efficacy evaluation of antimicrobial pesticides that are labeled for treating hard non-porous surfaces in healthcare settings contaminated with spores of Clostridium difficile.

  15. [The efficacy and safety of cefixime and amoxicillin/clavulanate in the treatment of asymptomatic bacteriuria in pregnant women: a randomized, prospective, multicenter study].

    PubMed

    Rafal'skiĭ, V V; Dovgan', E V; Kozyrev, Iu V; Gustovarova, T A; Khlybova, S V; Novoselova, A V; Filippenko, N G; Likhikh, D G

    2013-01-01

    The study was aimed to the evaluation of efficacy and safety of cefixime and amoxicillin/clavulanate in the treatment of asymptomatic bacteriuria in pregnant women. A prospective, multicenter, randomized study that included 112 pregnant women with asymptomatic bacteriuria was performed. 58 women were randomized in group 1 (cefixime [suprax solutab] 400 mg 1 time a day, 7 days), 54 women were included in group 2 (amoxicillin/clavulanate [amoksiklav] 625 mg 3 times a day, 7 days). The average age of the patients in group 1 was 25.2 +/- 6.6; in group 2--26.6 +/- 5.8 years. Physical examination, evaluation of complaints, collection of data on adverse reactions, and bacteriological analysis of urine were performed after enrollment in the study at visit 2 (day 10 +/- 1) and 3 (day 35 +/- 2). Comparable effectiveness of cefixime and amoxicillin/clavulanate in the treatment of asymptomatic bacteriuria in pregnant women was found. Eradication of the pathogen and sustained bacteriological response were observed in 94.8 and 92.7% of women treated with cefixime, and in 98.2 and 92.5% of women treated with amoxicillin/clavulanate, respectively (P > 0.05). At the same time, the use of amoxicillin/clavulanate compared with cefixime significantly higher was followed by the development of adverse reactions (13% and 1.7; respectively; P = 0.02). Seven-day courses of cefixime at a dose 400 mg 1 time a day and amoxicillin/clavulanate at a dose of 625 mg 3 times a day are high-effective treatment regimens for asymptomatic bacteriuria in pregnant women in Russia. The use of amoxicillin/clavulanate is significantly more often accompanied by the development of adverse reactions compared with cefixime.

  16. Prospective Randomized Controlled Study on the Efficacy of Multimedia Informed Consent for Patients Scheduled to Undergo Green-Light High-Performance System Photoselective Vaporization of the Prostate

    PubMed Central

    Ham, Dong Yeub; Choi, Woo Suk; Song, Sang Hoon; Ahn, Young-Joon; Park, Hyoung Keun; Kim, Hyeong Gon

    2016-01-01

    Purpose The aim of this study was to evaluate the efficacy of a multimedia informed consent (IC) presentation on the understanding and satisfaction of patients who were scheduled to receive 120-W green-light high-performance system photoselective vaporization of the prostate (HPS-PVP). Materials and Methods A multimedia IC (M-IC) presentation for HPS-PVP was developed. Forty men with benign prostatic hyperplasia who were scheduled to undergo HPS-PVP were prospectively randomized to a conventional written IC group (W-IC group, n=20) or the M-IC group (n=20). The allocated IC was obtained by one certified urologist, followed by a 15-question test (maximum score, 15) to evaluate objective understanding, and questionnaires on subjective understanding (range, 0~10) and satisfaction (range, 0~10) using a visual analogue scale. Results Demographic characteristics, including age and the highest level of education, did not significantly differ between the two groups. No significant differences were found in scores reflecting the objective understanding of HPS-PVP (9.9±2.3 vs. 10.6±2.8, p=0.332) or in subjective understanding scores (7.5±2.1 vs. 8.6±1.7, p=0.122); however, the M-IC group showed higher satisfaction scores than the W-IC group (7.4±1.7 vs. 8.4±1.5, p=0.033). After adjusting for age and educational level, the M-IC group still had significantly higher satisfaction scores. Conclusions M-IC did not enhance the objective knowledge of patients regarding this surgical procedure. However, it improved the satisfaction of patients with the IC process itself. PMID:27169129

  17. Efficacy and safety of early tacrolimus conversion to sirolimus after kidney transplantation: Long-term results of a prospective randomized study

    PubMed Central

    El-Agroudy, A. E.; Alarrayed, S. M.; Al-Ghareeb, S. M.; Farid, E.; Alhelow, H.; Abdulla, S.

    2017-01-01

    We report a prospective, open-label, randomized study to evaluate the safety and efficacy of converting patients with a stable renal function from tacrolimus (Tac)-based regimen to a sirolimus (SRL)-based regimen after kidney transplantation. Fifty-eight low-risk renal allograft recipients who receiving Tac 6 months posttransplant, were randomly assigned to continue Tac (n = 29) or convert to SRL (n = 29). We evaluated the 3-year outcomes including patient and graft survival, graft function, and safety profile. Three-year patient and graft survival in SRL and Tac groups were 93.1% versus 100% (P = 0.32), and 89.7% versus 100% (P = 0.11), respectively. However, the SRL group had a significantly better renal function, from the 2nd year posttransplant until the last follow-up. Four (13.8%) patients in the SRL group and 3 (10.3%) in the Tac group (P = 0.5) developed biopsy-proven acute rejection. Mean urinary protein excretion increased significantly after SRL conversion. Diastolic blood pressure was significantly lower at the end of the study in patients who eliminated Tac (80.4 vs. 75.6 mmHg in Tac and SRL group, respectively) (P = 0.03). Mean hemoglobin concentrations decreased after SRL conversion and remained significantly lower from 12 months to 36 months (P = 0.01). The mean serum cholesterol (540 ± 44 mg/dl) and triglyceride (177 ± 27 mg/dl) increased significantly in the SRL group, compared to Tac group (487 ± 62 mg/dl) (P = 0.03) and (141 ± 26 mg/dl) (P = 0.04). Our experience demonstrates that conversion to SRL from calcineurin inhibitors-based therapy may result in better renal function and blood pressure control in renal transplant recipients without an increased risk of acute rejection. However, these benefits have not resulted in a growing advantage in graft or patient survival. PMID:28182044

  18. Prospective diagnostic performance evaluation of single-voxel 1H MRS for typing and grading of brain tumours.

    PubMed

    Julià-Sapé, Margarida; Coronel, Indira; Majós, Carles; Candiota, Ana Paula; Serrallonga, Marta; Cos, Mònica; Aguilera, Carles; Acebes, Juan José; Griffiths, John R; Arús, Carles

    2012-04-01

    The purpose of this study was to evaluate whether single-voxel (1)H MRS could add useful information to conventional MRI in the preoperative characterisation of the type and grade of brain tumours. MRI and MRS examinations from a prospective cohort of 40 consecutive patients were analysed double blind by radiologists and spectroscopists before the histological diagnosis was known. The spectroscopists had only the MR spectra, whereas the radiologists had both the MR images and basic clinical details (age, sex and presenting symptoms). Then, the radiologists and spectroscopists exchanged their predictions and re-evaluated their initial opinions, taking into account the new evidence. Spectroscopists used four different systems of analysis for (1)H MRS data, and the efficacy of each of these methods was also evaluated. Information extracted from (1)H MRS significantly improved the radiologists' MRI-based characterisation of grade IV tumours (glioblastomas, metastases, medulloblastomas and lymphomas) in the cohort [area under the curve (AUC) in the MRI re-evaluation 0.93 versus AUC in the MRI evaluation 0.85], and also of the less malignant glial tumours (AUC in the MRI re-evaluation 0.93 versus AUC in the MRI evaluation 0.81). One of the MRS analysis systems used, the INTERPRET (International Network for Pattern Recognition of Tumours Using Magnetic Resonance) decision support system, outperformed the others, as well as being better than the MRI evaluation for the characterisation of grade III astrocytomas. Thus, preoperative MRS data improve the radiologists' performance in diagnosing grade IV tumours and, for those of grade II-III, MRS data help them to recognise the glial lineage. Even in cases in which their diagnoses were not improved, the provision of MRS data to the radiologists had no negative influence on their predictions.

  19. Efficacy and durability of hyaluronic acid fillers for malar enhancement: a prospective, randomized, spilt-face clinical controlled trial.

    PubMed

    Jeong, Ki Heon; Gwak, Min Jae; Moon, Sung Kyung; Lee, Sang Jun; Shin, Min Kyung

    2017-01-31

    Various hyaluronic acid fillers can be used for facial attenuation and rejuvenation. The efficacy and durability of hyaluronic acid fillers are of major concern to dermatologists and patients. This study aimed to evaluate three dimensional morphology, tissue distribution, and changes in volume after injection of two different hyaluronic acid fillers. Ten Korean women were enrolled in this study. Each subject was injected with monophasic hyaluronic acid filler in one malar area and biphasic filler in the other. Clinical outcome was measured before and after injection, and after 2, 4, 6, 8, 12, and 24 weeks, using the Global Aesthetic Improvement Scale, photographs and Moire's topography. Facial magnetic resonance imaging (MRI) was performed twice over six months. Both products showed good results after injection and demonstrated good durability over time. MRI was a useful modality for assessing tissue distribution and volume changes. The effects and durability after injection of monophasic hyaluronic acid filler and biphasic hyaluronic acid filler are generally comparable.

  20. Measuring Practicing and Prospective Elementary Teachers' Efficacy for Classroom Management: A Preliminary Development and Validation Study

    ERIC Educational Resources Information Center

    Putman, S. Michael

    2013-01-01

    Research has shown efficacy exerts a powerful influence on behavior. Classroom management represents one vehicle for demonstrations of these behaviors, yet few instruments focus solely on the measurement of this domain-specific form of efficacy. This research explored the relationship between teacher self-efficacy and classroom management through…

  1. Prospective Evaluation of Thoracic Ultrasound in the Detection of Pneumothorax

    NASA Technical Reports Server (NTRS)

    Schwarz, K. W.; Hamilton, D. R.; Kirkpatrick, A. W.; Billica, R. D.; Williams, D. R.; Diebel, L. N.; Sargysan, A. E.; Dulchavsky, S. A.

    2000-01-01

    Introduction: Pneumothorax (PTX) occurs commonly in trauma patients and is confirmed by examination and radiography. Thoracic ultrasound (VIS) has been suggested as an alternative method for rapidly diagnosing PTX when X-ray is unavailable as in rural, military, or space flight settings; however, its accuracy and specificity are not known. Methods: We evaluated the accuracy of thoracic U/S detection of PTX compared to radiography in stable, emergency patients with a high suspicion of PTX at a Level-l trauma center over a 6-month period. Following University and NASA Institutional Review Board approval, informed consent was obtained from patients with penetrating or blunt chest trauma, or with a history consistent with PTX. Whenever possible, the presence or absence of the " lung sliding" sign or the "comet tail" artifact were determined by U/S in both hemithoraces by residents instructed in thoracic U/S before standard radiologic verification of PTX. Results were recorded on data sheets for comparison to standard radiography. Results: Thoracic VIS had a 94% sensitivity; two PTX could not be reliably diagnosed due to subcutaneous air; the true negative rate was 100%. In one patient, the VIS exam was positive while X ray did not confirm PTX; a follow-up film 1 hour later demonstrated a small PTX. The average time for bilateral thoracic VIS examination was 2 to 3 minutes. Conclusions: Thoracic ultrasound reliably diagnoses pneumothorax. Presence of the "lung sliding" sign conclusively excludes pneumothorax. Expansion of the FAST examination to include the thorax should be investigated.

  2. Evaluation of safety and efficacy of a new multipurpose disinfecting solution on silicone hydrogel contact lenses☆

    PubMed Central

    Pinto-Fraga, José; Blázquez Arauzo, Francisco; Urbano Rodríguez, Rubén; González-García, María J.

    2014-01-01

    Purpose To evaluate the safety and efficacy of a new multipurpose disinfecting solution (MPDS) with a formulation that includes aloe vera on its composition. Methods This is a prospective, randomized, double-masked clinical trial with a crossover design that included seven examinations. Two different MPDSs, Avizor Alvera® (study solution) and All Clean Soft® (control solution), each were used for 1 month. Comfilcon A silicone hydrogel contact lenses were used during the trial. The main outcome variables were corneal staining and deposits on the surfaces of the contact lenses. Other parameters including ocular surface response, contact lens wettability, user satisfaction, and adverse events, were analyzed according to the International Organization for Standardization (ISO) 11980:2010 guidance for clinical investigation. Results Twenty subjects (10 women, 10 men) (mean age, 27.7 ± 5.6 years; range, 20–41) were included. No differences between both MPDSs were found in the percentage of subjects with corneal staining >0 at day 30 (study: 35%, control: 50%; p = 0.46); neither in the percentage of subjects with deposits on the surface of the contact lens >0 at day 30 (study: 26.32%, control: 52.63%; p = 0.18). The study MPDS received higher rates in comfort (study: 8.14 ± 1.09, control: 7.94 ± 0.92; p = 0.56) and satisfaction at day 30 (study: 8.63 ± 0.91, control: 8.29 ± 0.80; p = 0.19), however the scores were not significantly different with the control MPDS. Conclusions The clinical trial showed that the study MPDS is safe, efficient, and has acceptable physiologic tolerance, according to the ISO 11980:2010 guidance for clinical investigation. PMID:25649640

  3. Efficacy of using Zaontz urethral stent in hypospadias repair by the Face, Legs, Activity, Cry, Consolability (FLACC) scale: A prospective study

    PubMed Central

    Ozcan, Serkan; Bagcioglu, Murat; Karakan, Tolga; Diri, Mehmet Akif; Demirbas, Arif

    2017-01-01

    Introduction: The developments in hypospadias surgical techniques and materials are intended to improve surgery outcomes and patient comfort. The aim of this study is to determine the effect of the Zaontz urethral stent (ZUS) (Cook Medical) on patient comfort and surgical success rates in children undergoing hypospadias surgery. Methods: A feeding tube was used to repair 46 cases of primary distal hypospadias, and ZUS (6F, 8F, and 10F in diameter) was used to repair to 31 cases of primary distal hypospadias between December 2009 and June 2011 in our clinic. ZUS was compared with the feeding tube in terms of surgical success rates and patient comfort in assessments made during postoperative periods. Results: The patients with ZUS were followed with a stent for seven days postoperatively, as were the patients with the feeding tube. There was no statistical difference between the two groups in terms of fistula formation (p>0.05). Patient comfort was evaluated by the Face, Legs, Activity, Cry, Consolability (FLACC) scale on the first and third postoperative days, and a statistically significant difference was observed in favour of ZUS on the third postoperative day (p<0.05). Conclusions: Compared with a feeding tube in hypospadias repair, ZUS does not make any contribution to the urinary fistula rates. However, ZUS may have an advantage in terms of patient comfort in the postoperative followup. On the other hand, the small number of patients and the high price of the ZUS were the most important limitations. Prospective, randomized trials are needed to assess efficacy and cost. PMID:28163807

  4. A Study on Prospective Teachers' Self-Efficacy Beliefs Regarding the Implementation of Constructivist Approach (A Case of Konya)

    ERIC Educational Resources Information Center

    Ektem, Isil Sönmez

    2016-01-01

    The purpose of this study was to reveal prospective teachers' perceptions and views about the implementation of the constructivist approach. The study was conducted on 528 prospective teachers in their 4th year at Necmettin Erbakan University Ahmet Kelesoglu Education Faculty and Selcuk University Faculty of Science and Faculty of Letters in the…

  5. Effect of Oral Premedication on the Efficacy of Inferior Alveolar Nerve Block in Patients with Symptomatic Irreversible Pulpitis: A Prospective, Double-Blind, Randomized Controlled Clinical Trial

    PubMed Central

    Saha, Suparna Ganguly; Dubey, Sandeep; Kala, Shubham; Misuriya, Abhinav; Kataria, Devendra

    2016-01-01

    Introduction It is generally accepted that achieving complete anaesthesia with an Inferior Alveolar Nerve Block (IANB) in mandibular molars with symptomatic irreversible pulpitis is more challenging than for other teeth. Therefore, administration of Non-Steroidal Anti-Inflammatory Agents (NSAIDs) 1 hour prior to anaesthetic administration has been proposed as a means to increase the efficacy of the IANB in such patients. Aim The purpose of this prospective, double-blind, randomized clinical trial was to determine the effect of administration of oral premedication with ketorolac (KETO) and diclofenac potassium (DP) on the efficacy of IANB in patients with irreversible pulpitis. Materials and Methods One hundred and fifty patients with irreversible pulpitis were evaluated preoperatively for pain using Heft Parker visual analogue scale, after which they were randomly divided into three groups. The subjects received identical tablets of ketorolac, diclofenac pottasium or cellulose powder (placebo), 1 hour prior to administration of IANB with 2% lidocaine containing 1:200 000 epinephrine. Lip numbness as well as positive and negative responses to cold test were ascertained. Additionally pain score of each patient was recorded during cavity preparation and root canal instrumentation. Success was defined as the absence of pain or mild pain based on the visual analog scale readings. The data was analysed using One-Way Anova, Post-Hoc Tukey pair wise, Paired T – Test and chi-square test. Trial Registery Number is 4722/2015 for this clinical trial study. Results There were no significant differences with respect to age (p =0.098), gender (p = 0.801) and pre-VAS score (DP-KETO p=0.645, PLAC-KETO p =0.964, PLAC-DP p = 0.801) between the three groups. All patients had subjective lip anaesthesia with the IAN blocks. Patients of all the three groups reported a significant decrease in active pain after local anaesthesia (p< 0.05). The post injection VAS Score was least in group

  6. Safety profiles and efficacy of infliximab therapy in Japanese patients with plaque psoriasis with or without psoriatic arthritis, pustular psoriasis or psoriatic erythroderma: Results from the prospective post-marketing surveillance.

    PubMed

    Torii, Hideshi; Terui, Tadashi; Matsukawa, Miyuki; Takesaki, Kazumi; Ohtsuki, Mamitaro; Nakagawa, Hidemi

    2016-07-01

    A large-scale prospective post-marketing surveillance was conducted to evaluate the safety and efficacy of infliximab in Japanese patients with plaque psoriasis, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma. This study was conducted in all psoriasis patients treated with infliximab after its Japanese regulatory approval. Infliximab was administrated at 5 mg/kg at weeks 0, 2 and 6, and every 8 weeks thereafter. Patients were serially enrolled and observed for 6 months to evaluate the safety and efficacy. The safety and efficacy were evaluated in 764 and 746 patients, respectively. Incidences of any and serious adverse drug reactions were 22.51% and 6.94%, respectively, and those of any and serious infusion reactions were 6.15% and 1.31%, respectively, which were comparable with the results in the post-marketing surveillance with 5000 rheumatoid arthritis patients in Japan. Major adverse drug reactions during the follow-up period were infections (5.10%) including pneumonia, cellulitis and herpes zoster, however, no tuberculosis was observed. The safety profiles were equivalent, regardless of the psoriasis types. No new safety problems were identified. The response rates on global improvement and median improvement rate of Psoriasis Area and Severity Index in all patients were 88.0% and 85.0%, respectively. Of note, the efficacy was equivalent for each psoriasis type as well as for each body region. Infliximab was also effective in pustular psoriasis symptoms, joint symptoms and nail psoriasis, as well as improvement of quality of life. Infliximab was confirmed to be highly effective and well tolerated in treating refractory psoriasis, including pustular psoriasis and psoriatic erythroderma.

  7. A prospective study of the efficacy of magnetic resonance spectroscopy imaging for predicting locally advanced prostate cancer

    PubMed Central

    Razi, Ali; Parizi, Mehdi Kardoust; Kazemeini, Seid Mohammad; Abedi, Akbar

    2015-01-01

    Objective: To evaluate the efficacy of magnetic resonance spectroscopy imaging (MRSI) for predicting locally advanced prostate cancer (PC). Materials and methods: Between April 2009 and July 2012, 80 consecutive patients with clinically localized PC had undergone endorectal MRSI before radical retropubic prostatectomy. Clinicopathological parameters, including age, preoperative prostate-specific antigen (PSA), Gleason score (GS) at biopsy, perinural invasion at biopsy, prostate weight at surgery, GS of surgical specimen, and pathological staging were recorded. The MRSI findings were compared with the histopathological findings of the radical prostatectomy. The diagnostic accuracy measures consisting of sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) of MRSI, and other variables in the diagnosis of locally advanced PC (Pathology Stages pT3a, pT3b, or pT4) were evaluated. Results: Sensitivity, specificity, PPV, and NPV of MRSI in detecting locally advanced PC is 42.4%, 93.6%, 82.3%, and 69.8%, respectively [area under the receiver operating characteristic (ROC) curve=0.658, p value <0.0001]. MRSI, cancer-positive core percentage at biopsy, and GS at biopsy are more accurate factors among all the predictive variables in predicting locally advanced PC. Conclusion: MRSI may be considered as a complementary diagnostic modality with high specificity and moderate sensitivity in predicting locally advanced PC. Combination of this modality with other predictive factors helps the surgeon and patient to select an appropriate treatment strategy. PMID:26328204

  8. DISTRIBUTED AND ACCUMULATED REINFORCEMENT ARRANGEMENTS: EVALUATIONS OF EFFICACY AND PREFERENCE

    PubMed Central

    DELEON, ISER G.; CHASE, JULIE A.; FRANK-CRAWFORD, MICHELLE A.; CARREAU-WEBSTER, ABBEY B.; TRIGGS, MANDY M.; BULLOCK, CHRISTOPHER E.; JENNETT, HEATHER K.

    2015-01-01

    We assessed the efficacy of, and preference for, accumulated access to reinforcers, which allows uninterrupted engagement with the reinforcers but imposes an inherent delay required to first complete the task. Experiment 1 compared rates of task completion in 4 individuals who had been diagnosed with intellectual disabilities when reinforcement was distributed (i.e., 30-s access to the reinforcer delivered immediately after each response) and accumulated (i.e., 5-min access to the reinforcer after completion of multiple consecutive responses). Accumulated reinforcement produced response rates that equaled or exceeded rates during distributed reinforcement for 3 participants. Experiment 2 used a concurrent-chains schedule to examine preferences for each arrangement. All participants preferred delayed, accumulated access when the reinforcer was an activity. Three participants also preferred accumulated access to edible reinforcers. The collective results suggest that, despite the inherent delay, accumulated reinforcement is just as effective and is often preferred by learners over distributed reinforcement. PMID:24782203

  9. Distributed and accumulated reinforcement arrangements: evaluations of efficacy and preference.

    PubMed

    DeLeon, Iser G; Chase, Julie A; Frank-Crawford, Michelle A; Carreau-Webster, Abbey B; Triggs, Mandy M; Bullock, Christopher E; Jennett, Heather K

    2014-01-01

    We assessed the efficacy of, and preference for, accumulated access to reinforcers, which allows uninterrupted engagement with the reinforcers but imposes an inherent delay required to first complete the task. Experiment 1 compared rates of task completion in 4 individuals who had been diagnosed with intellectual disabilities when reinforcement was distributed (i.e., 30-s access to the reinforcer delivered immediately after each response) and accumulated (i.e., 5-min access to the reinforcer after completion of multiple consecutive responses). Accumulated reinforcement produced response rates that equaled or exceeded rates during distributed reinforcement for 3 participants. Experiment 2 used a concurrent-chains schedule to examine preferences for each arrangement. All participants preferred delayed, accumulated access when the reinforcer was an activity. Three participants also preferred accumulated access to edible reinforcers. The collective results suggest that, despite the inherent delay, accumulated reinforcement is just as effective and is often preferred by learners over distributed reinforcement.

  10. Efficacy of IP6 + inositol in the treatment of breast cancer patients receiving chemotherapy: prospective, randomized, pilot clinical study

    PubMed Central

    2010-01-01

    Background Prospective, randomized, pilot clinical study was conducted to evaluate the beneficial effects of inositol hexaphosphate (IP6) + Inositol in breast cancer patients treated with adjuvant therapy. Patients and methods Patients with invasive ductal breast cancer where polychemotherapy was indicated were monitored in the period from 2005-2007. Fourteen patients in the same stage of ductal invasive breast cancer were involved in the study, divided in two randomized groups. One group was subjected to take IP6 + Inositol while the other group was taking placebo. In both groups of patients the same laboratory parameters were monitored. When the treatment was finished, all patients have filled questionnaires QLQ C30 and QLQ-BR23 to determine the quality of life. Results Patients receiving chemotherapy, along with IP6 + Inositol did not have cytopenia, drop in leukocyte and platelet counts. Red blood cell counts and tumor markers were unaltered in both groups. However, patients who took IP6 + Inositol had significantly better quality of life (p = 0.05) and functional status (p = 0.0003) and were able to perform their daily activities. Conclusion IP6 + Inositol as an adjunctive therapy is valuable help in ameliorating the side effects and preserving quality of life among the patients treated with chemotherapy. PMID:20152024

  11. Nubac Disc Arthroplasty: Preclinical Studies and Preliminary Safety and Efficacy Evaluations

    PubMed Central

    Songer, Matthew; Pimenta, Luis; Werner, Dieter; Reyes-Sanchez, Alejandro; Balsano, Massimo; Agrillo, Umberto; Coric, Domagoj; Davenport, Kenneth; Yuan, Hansen

    2007-01-01

    Background Disc arthroplasty is gaining popularity for treatment of low-back pain caused by degenerative disc disease (DDD). It can involve total disc replacement or partial disc or nucleus replacement (or augmentation). Compared with total disc replacement, nucleus replacement is less invasive, has less surgical risk, has faster postoperative recovery, and doesn't “burn bridges” should further surgery be required. However, nucleus replacement has a high risk of implant expulsion because the device is not fixed to the vertebrae. Nubac is the first polyetheretherketone (PEEK)-on-PEEK articulated disc arthroplasty device designed to optimally restore the lumbar anatomy and biomechanics. Methods ISO 10993 standards were used to evaluate the biocompatibility of the PEEK material. Chemical and thermal–mechanical tests and in vivo study assessed PEEK's biostability after exposure to high g irradiation and harsh oxidative conditions. Biomechanical tests to evaluate kinematic properties and anatomical restoration of the implanted lumbar motion segments and implant expulsion risk assessments were performed with a human cadaveric model. Because of the novelty of PEEK-on-PEEK as a self-mating articulating material, extensive wear tests were conducted with unidirectional and coupled motions. Static and fatigue strength also were tested. Animal study with a baboon model was conducted with gross, radiographic, biomechanical, and histological evaluations at 6 and 12 months postoperatively. Preliminary clinical data were collected through a prospective multicenter cohort study. Results PEEK demonstrated exceptional biocompatibility and biodurability. Nubac restored disc height and motion segment range of motion. The unique articulating design of the Nubac demonstrated low risk of implant expulsion in a human cadaveric model. Wear tests showed that the Nubac has minimal wear and compares favorably to other disc arthroplasty materials. The Nubac also had excellent static and

  12. Safety and Efficacy of 5-Aminolevulinic Acid for High Grade Glioma in Usual Clinical Practice: A Prospective Cohort Study

    PubMed Central

    Teixidor, Pilar; Vidal, Xavier; Montané, Eva

    2016-01-01

    Background During the last decade, the use of 5-aminolevulinic acid (5-ALA) has been steadily increasing in neurosurgery. The study's main objectives were to prospectively evaluate the effectiveness and safety of 5-ALA when used in clinical practice setting on high-grade gliomas’ patients. Methods National, multicenter and prospective observational study. Inclusion criteria: authorized conditions of use of 5-ALA. Exclusion criteria: contraindication to 5-ALA, inoperable or partial resected tumors, pregnancy and children. Epidemiological, clinical, laboratory, radiological, and safety data were collected. Effectiveness was assessed using complete resection of the tumor, and progression-free and overall survival probabilities. Results Between May 2010 and September 2014, 85 patients treated with 5-ALA were included, and 77 were suitable for the effectiveness analysis. Complete resection was achieved in 41 patients (54%). Surgeons considered suboptimal the fluorescence of 5-ALA in 40% of the patients assessed. The median duration of follow-up was 12.3 months. The progression-free survival probability at 6 months was 58%. The median duration overall survival was 14.2 months. Progression tumor risk factors were grade of glioma, age and resection degree; and death risk factors were grade of glioma and gender. No severe adverse effects were reported. At one month after surgery, new or increased neurological morbidity was 6.5%. Hepatic enzymes were frequently increased within the first month after surgery; however, they subsequently normalized, and this was found to have no clinical significance. Conclusion In clinical practice, the 5-ALA showed a good safety profile, but the benefits related to 5-ALA have not been yet clearly shown. The improved differentiation expected by fluorescence between normal and tumor cerebral tissue was suboptimal in a relevant number of patients; in addition, the expected higher degree of resection was lower than in clinical trials as well as

  13. Algorithms for detecting and predicting influenza outbreaks: metanarrative review of prospective evaluations

    PubMed Central

    Spreco, A; Timpka, T

    2016-01-01

    Objectives Reliable monitoring of influenza seasons and pandemic outbreaks is essential for response planning, but compilations of reports on detection and prediction algorithm performance in influenza control practice are largely missing. The aim of this study is to perform a metanarrative review of prospective evaluations of influenza outbreak detection and prediction algorithms restricted settings where authentic surveillance data have been used. Design The study was performed as a metanarrative review. An electronic literature search was performed, papers selected and qualitative and semiquantitative content analyses were conducted. For data extraction and interpretations, researcher triangulation was used for quality assurance. Results Eight prospective evaluations were found that used authentic surveillance data: three studies evaluating detection and five studies evaluating prediction. The methodological perspectives and experiences from the evaluations were found to have been reported in narrative formats representing biodefence informatics and health policy research, respectively. The biodefence informatics narrative having an emphasis on verification of technically and mathematically sound algorithms constituted a large part of the reporting. Four evaluations were reported as health policy research narratives, thus formulated in a manner that allows the results to qualify as policy evidence. Conclusions Awareness of the narrative format in which results are reported is essential when interpreting algorithm evaluations from an infectious disease control practice perspective. PMID:27154479

  14. Comparative clinical efficacy evaluation of three gingival displacement systems

    PubMed Central

    Shrivastava, Kirti Jajoo; Bhoyar, Anjali; Agarwal, Surendra; Shrivastava, Saurabh; Parlani, Swapnil; Murthy, Varsha

    2015-01-01

    Aim: We compared the clinical efficacy of three gingival displacement systems to accurately record intra-crevicular margins of tooth preparation. Materials and Methods: One mechanical (magic foam cord) and two chemico-mechanical (expasyl paste and retraction cord impregnated with 15% aluminum chloride) gingival displacement systems were used. This study was conducted on the maxillary central incisors of 20 patients (20-60 years old) requiring full coverage restoration. All the three gingival displacement systems were tested in three sessions at an interval of 14 days in same order. The casts were sectioned and viewed under an optical microscope, followed by quantitative measurements of the width of the pre and postretracted sulci. Results: All the three displacement systems produced highly significant horizontal gingival displacement. Retraction cord soaked in 15% aluminum chloride produced maximum displacement (0.74 mm), followed by expasyl paste (0.48 mm) whereas magic foam cord produced the least displacement (0.41 mm). Conclusions: Gingival displacement shown by each displacement system was found to be more than the accepted value necessary for elastomeric impression accuracy (0.2 mm) to record intra-crevicular margins of tooth preparation. PMID:26604620

  15. [Comparative evaluation of the antihypertensive efficacy of amlodipine versus enalapril].

    PubMed

    Alicajić, Fredi

    2009-01-01

    Goal of this study was to compare the efficacy and safety of amlodipine with enalaprile in case of patients with moderate essential arterial hypertension. Study involved 40 patients with hypertension, 22 males and 18 females, age 39-80 years. Diastolic blood pressure was from 100-120 mmHg. Patients were for two weeks without any therapy and after that were divided into two groups of 20, fortherapy with amlodipine or enalaprile. The patients received 5-10 mg of amlodipine or enalaprile once daily. Initial blood pressure, before therapy was similar in groups, 173.00/108.00 mmHg and 175.25/106.75 mmHg (mean value). After four weeks on treatment the BP was reduced in both groups, in group on amlodipine from 173.00/108.00 to 129.75/78.50 mmHg (mean value), and in the group on enalaprile from 175.25/106.75 to 133.50/81.50 mmHg. Patients did not report any side effects in either of the groups. We prove that one day therapy with small doses, 5-10 mg of amlodipine, new calcium channels blocker and enalaprile, ACE inhibitor were efficient and safe in therapy of the essential hypertension. We found that amlodipine was somewhat more efficient than enalaprile in lowering the blood pressure.

  16. Re-evaluation of ivermectin efficacy against equine gastrointestinal parasites.

    PubMed

    Klei, T R; Rehbein, S; Visser, M; Langholff, W K; Chapman, M R; French, D D; Hanson, P

    2001-07-27

    Two trials were conducted to confirm the efficacy of ivermectin paste against endoparasites of horses. In these trials, 20 ponies were treated with ivermectin oral paste at 200 mcg x kg body weight once on Day 0, and 20 ponies served as unmedicated controls. The animals carried naturally acquired parasite infections as confirmed by pretrial fecal examination. The animals were necropsied for worm recovery on Days 14, 15 or 16. Parasites recovered were identified to species. Horses treated with ivermectin had significantly (P<0.05) fewer (>99.0% reduction) adult small strongyles (Coronocyclus spp including C. coronatus, C. labiatus, C. labratus; Cyathostomum spp including C. catinatum, C. pateratum; Cylicocyclus spp including C. ashworthi, C. elongatus, C. insigne, C. leptostomum, C. nassatus, C. radiatus; Cylicodontophorus bicoronatus; Cylicostephanus spp including C. asymetricus, C. bidentatus, C. calicatus, C. goldi, C. longibursatus, C. minutus; Gyalocephalus capitatus; Parapoteriostomum spp including P. euproctus, P. mettami; Petrovinema poculatum; Poteriostomum spp including P. imparidentatum, P. ratzii) and adult large strongyles (Strongylus edentatus, S. vulgaris; Triodontophorus spp including T. brevicauda, T. serratus; Craterostomum acuticaudatum) than the controls. Ivermectin was also highly effective (94% to >99%, P<0.05-0.01) against Gasterophilus intestinalis larvae, Habronema spp., Oxyuris equi, Parascaris equorum. The data from these two trials confirm that ivermectin paste administered to horses orally at 200mcg x kg(-1) continues to be highly effective for treatment and control of a broad range of small and large strongyle species as well as other species of gastrointestinal parasites.

  17. Evaluation of adjuvant effects of fucoidan for improving vaccine efficacy.

    PubMed

    Kim, Su-Yeon; Joo, Hong-Gu

    2015-01-01

    Fucoidan is a sulfated polysaccharide derived from brown seaweed, including Fucus vesiculosus. This compound is known to have immunostimulatory effects on various types of immune cells including macrophages and dendritic cells. A recent study described the application of fucoidan as a vaccine adjuvant. Vaccination is regarded as the most efficient prophylactic method for preventing harmful or epidemic diseases. To increase vaccine efficacy, effective adjuvants are needed. In the present study, we determined whether fucoidan can function as an adjuvant using vaccine antigens. Flow cytometric analysis revealed that fucoidan increases the expression of the activation markers major histocompatibility complex class II, cluster of differentiation (CD)25, and CD69 in spleen cells. In combination with Bordetella bronchiseptica antigen, fucoidan increased the viability and tumor necrosis factor-α production of spleen cells. Furthermore, fucoidan increased the in vivo production of antigen-specific antibodies in mice inoculated with Mycoplasma hyopneumoniae antigen. Overall, this study has provided valuable information about the use of fucoidan as a vaccine adjuvant.

  18. Evaluating the Efficacy of the Cloud for Cluster Computation

    NASA Technical Reports Server (NTRS)

    Knight, David; Shams, Khawaja; Chang, George; Soderstrom, Tom

    2012-01-01

    Computing requirements vary by industry, and it follows that NASA and other research organizations have computing demands that fall outside the mainstream. While cloud computing made rapid inroads for tasks such as powering web applications, performance issues on highly distributed tasks hindered early adoption for scientific computation. One venture to address this problem is Nebula, NASA's homegrown cloud project tasked with delivering science-quality cloud computing resources. However, another industry development is Amazon's high-performance computing (HPC) instances on Elastic Cloud Compute (EC2) that promises improved performance for cluster computation. This paper presents results from a series of benchmarks run on Amazon EC2 and discusses the efficacy of current commercial cloud technology for running scientific applications across a cluster. In particular, a 240-core cluster of cloud instances achieved 2 TFLOPS on High-Performance Linpack (HPL) at 70% of theoretical computational performance. The cluster's local network also demonstrated sub-100 ?s inter-process latency with sustained inter-node throughput in excess of 8 Gbps. Beyond HPL, a real-world Hadoop image processing task from NASA's Lunar Mapping and Modeling Project (LMMP) was run on a 29 instance cluster to process lunar and Martian surface images with sizes on the order of tens of gigapixels. These results demonstrate that while not a rival of dedicated supercomputing clusters, commercial cloud technology is now a feasible option for moderately demanding scientific workloads.

  19. Efficacy and tolerability of an ectoine mouth and throat spray compared with those of saline lozenges in the treatment of acute pharyngitis and/or laryngitis: a prospective, controlled, observational clinical trial.

    PubMed

    Müller, Dörte; Lindemann, Torben; Shah-Hosseini, Kija; Scherner, Olaf; Knop, Markus; Bilstein, Andreas; Mösges, Ralph

    2016-09-01

    The aim of this observational trial was to evaluate the efficacy and tolerability of a mouth and throat spray containing ectoine in the treatment of acute pharyngitis and/or laryngitis. The outcome was compared with control treatment using saline lozenges. This study was designed as a prospective, controlled, non-randomized, observational multicenter clinical trial and was conducted in Germany. The study population consisted of 95 patients. The decision for treatment with either spray or lozenges was based on the patients' preference for pharyngeal or oral application. Investigators assessed symptoms specific to acute pharyngitis/laryngitis and determined the pharyngitis symptom score. Both patients and investigators evaluated the tolerability and efficacy of the treatment applied. Treatment with the spray showed higher efficacy, 1.95 ± 0.81 versus 1.68 ± 0.67 (investigators) and 1.97 ± 0.88 versus 1.57 ± 0.69 (patients, p < 0.05). Treatment with the spray resulted in significantly greater reduction of cervical lymph node swelling (p < 0.05), ∆ spray = 0.44 ± 0.62, ∆ lozenges = 0.21 ± 0.62. The lozenges showed some advantage in relieving cough, ∆ lozenges = 0.62 ± 0.94 versus ∆ spray = 0.44 ± 0.85. Both patients and investigators rated the tolerability of both medical devices as "good" to "very good". Adverse events of mild to moderate severity were either possibly related or not related to the medical devices used. No serious adverse events occurred. Taken together, while the tolerability was consistent in both treatment groups, the ectoine-based spray showed superior efficacy in treating acute pharyngitis and/or laryngitis.

  20. Formula to evaluate efficacy of vaccines and systemic substances against three-host ticks.

    PubMed

    Aguirre, André de Abreu Rangel; Garcia, Marcos Valério; Szabó, Matias Pablo Juan; Barros, Jacqueline Cavalcante; Andreotti, Renato

    2015-05-01

    The control of ticks with vaccines is of global interest. Experimental vaccines incorporate new technologies as soon as they are available. Historically, the main vaccine studies have focused on the one-host cattle tick Rhipicephalus microplus, and efficacy evaluations have been standardised for this tick species. On the other hand, evaluations of vaccine candidates for three-host ticks are being done somewhat arbitrarily and thus comparisons within the current literature on the efficacy of vaccines, as well as other methods of control, are difficult. We herein provide a formula for the evaluation of efficacy of a vaccine designed against three-host ticks that incorporates the whole life cycle of the tick.

  1. Evaluation of the pressure ulcers risk scales with critically ill patients: a prospective cohort study 1

    PubMed Central

    Borghardt, Andressa Tomazini; do Prado, Thiago Nascimento; de Araújo, Thiago Moura; Rogenski, Noemi Marisa Brunet; Bringuente, Maria Edla de Oliveira

    2015-01-01

    AIMS: to evaluate the accuracy of the Braden and Waterlow risk assessment scales in critically ill inpatients. METHOD: this prospective cohort study, with 55 patients in intensive care units, was performed through evaluation of sociodemographic and clinical variables, through the application of the scales (Braden and Waterlow) upon admission and every 48 hours; and through the evaluation and classification of the ulcers into categories. RESULTS: the pressure ulcer incidence was 30.9%, with the Braden and Waterlow scales presenting high sensitivity (41% and 71%) and low specificity (21% and 47%) respectively in the three evaluations. The cut off scores found in the first, second and third evaluations were 12, 12 and 11 in the Braden scale, and 16, 15 and 14 in the Waterlow scale. CONCLUSION: the Braden scale was shown to be a good screening instrument, and the Waterlow scale proved to have better predictive power. PMID:25806628

  2. A Bayesian model for evaluating influenza antiviral efficacy in household studies with asymptomatic infections.

    PubMed

    Yang, Yang; Halloran, M Elizabeth; Longini, Ira M

    2009-04-01

    Antiviral agents are an important component in mitigation/containment strategies for pandemic influenza. However, most research for mitigation/containment strategies relies on the antiviral efficacies evaluated from limited data of clinical trials. Which efficacy measures can be reliably estimated from these studies depends on the trial design, the size of the epidemics, and the statistical methods. We propose a Bayesian framework for modeling the influenza transmission dynamics within households. This Bayesian framework takes into account asymptomatic infections and is able to estimate efficacies with respect to protecting against viral infection, infection with clinical disease, and pathogenicity (the probability of disease given infection). We use the method to reanalyze 2 clinical studies of oseltamivir, an influenza antiviral agent, and compare the results with previous analyses. We found significant prophylactic efficacies in reducing the risk of viral infection and infection with disease but no prophylactic efficacy in reducing pathogenicity. We also found significant therapeutic efficacies in reducing pathogenicity and the risk of infection with disease but no therapeutic efficacy in reducing the risk of viral infection in the contacts.

  3. Evaluating the efficacy of a new flossing aid.

    PubMed

    Spolsky, V W; Perry, D A; Meng, Z; Kissel, P

    1993-08-01

    The purpose of this clinical trial was to compare the efficacy of a new flossing aid (Flosser) with finger flossing on preventing plaque and gingival inflammation. 35 adults who did not use dental floss routinely were assigned randomly to one of 2 treatment groups (Flosser or finger flossing) in a 2-period, single-blind crossover study. After prophylaxis, subjects were instructed to use the flossing aid or finger floss 1 x per day and to continue brushing for 30 days. Gingival inflammation (GI & BPI) and plaque (PI) were assessed prior to the prophylaxis and at 30 days. After a 30 day "washout" period, subjects were again reassessed for gingival inflammation and plaque, given a prophylaxis, assigned the opposite treatment (2nd treatment period) that they received the first treatment period, and assessed (GI, BPI & PI) after 30 days. Comparing the mean difference of the 30-day buccal interproximal scores between the treatment groups (flossing aid scores minus finger flossing scores) showed that the mean differences with 95% CI were: -0.013 +/- 0.067 [GI], -0.017 +/- 0.044 [BP] and 0.019 +/- 0.014 [PI]. No statistically significant differences from zero (0.05 alpha) were observed using the t-test. There was a high level of compliance (90%) with the prescribed regiment, and subjects preferred (56%) the flossing aid slightly over finger flossing. Even though there were no statistically or clinically significant differences in gingivitis and plaque scores between the 2 flossing groups, the positive inclination for the flossing aid makes it a desirable addition to the armamentarium of preventive dentistry.

  4. Safety and efficacy of vertebroplasty in the treatment of osteoporotic vertebral compression fractures: a prospective multicenter international randomized controlled study

    PubMed Central

    Leali, Paolo Tranquilli; Solla, Federico; Maestretti, Gianluca; Balsano, Massimo; Doria, Carlo

    2016-01-01

    Summary Background Vertebral compression fractures (VCFs) treated non-operatively can diminish function and quality of life, and lead to chronic health effects. The short-term safety and effectiveness of vertebroplasty for symptomatic VCFs are well-documented, but long-term follow-up is needed. Purpose The aim of this paper was to analyse a multicenter international experience of 200 compression fractures treated with percutaneous vertebroplasty (VP) and compare the results of this procedure with the result of 200 patients treated conservatively. To estimate cost-effectiveness of VP compared to conservative care in terms of: pain reduction, quality of life, complications, secondary fractures and mortality. Materials and methods 400 patients have been enrolled in a prospective randomized controlled study with painful VCFs with bone edema on MR imaging, local back pain for 6 weeks or less, osteoporosis and aged 55 years or older; after obtaining informed consent patients are included and randomized for VP or conservative care. Before treatment and at follow-up with regular intervals during 1-year period were administered to patients standard questionnaires addressing: clinical symptoms, pain medication, Visual Analogue Scale (VAS) score for pain, Oswestry Disability Index (ODI) score to evaluate functional activity. Results 200 patients treated with PV compared with 200 patients treated conservatively had significantly better VAS and used less analgesics 1 day after treatment. Twenty-four hours after VP, there was a reduction in pain scores and an improvement in physical functions, whereas remain unchanged in the patients treated conservatively. Conclusions Pain relief and improvement of mobility and function after PV is immediate and significantly better in the short term compared with non-surgical care treatment. PMID:28228788

  5. A multicenter prospective trial evaluating fetal bovine dermal graft (Xenform® Matrix) for pelvic reconstructive surgery

    PubMed Central

    2010-01-01

    Background A prospective multicenter clinical study was performed to evaluate the safety and efficacy of a bovine dermal graft (Xenform® Matrix, Boston Scientific, Natick, MA, USA) during vaginal reconstructive surgery. Methods Forty-five women with ICS stage 2 or higher pelvic organ prolapse (POP) were enrolled at 4 centers. POP-Q, pelvic floor function (PFDI-20), sexual function (PISQ-12), and patient satisfaction tools were used to assess subjects at baseline, and at 2 and 6 weeks, and 3, 6 and 12 months post surgery. The significance of symptom score changes at 6 months and 1 year were determined by the t-test for paired data. Forty-three of the 45 patients completed the 12 month study. Results The majority of the subjects had cystocele (98%) and/or rectocele (84%) defects at study entry. At 12 months, 74% of the defects had improved to a stage 0 or 1. Mean PFDI-20 scores improved by 72% (p < 0.001) at 12 months, and PISQ-12 scores were maintained during the follow-up period indicating no decline in sexual function. Three subjects experienced one serious adverse event each; one of the adverse events (constipation) was deemed by the study physician to be unrelated to Xenform®. One subject had severe pyelonephritis resulting in dialysis. This subject had a previous history of pyelonephritis, sepsis and acute renal failure. The third subject had a reported recurrent cystocele of moderate severity, possibly related to the device. No graft related erosions or pain lasting more than 30 days were reported. No subjects withdrew due to an adverse event. Conclusion This study is the first to investigate the use of Xenform® Matrix in vaginal reconstructive surgery among patients with POP. Significant improvement was maintained at 12 months utilizing both objective and subjective assessment tools, confirming the safety and efficacy of this material in vaginal surgery. Trial Registration ClinicalTrials.gov NCT01244165 PMID:21144043

  6. Efficacy and safety of rapid escalation of cabergoline in comparison to conventional regimen for macroprolactinoma: A prospective, randomized trial

    PubMed Central

    Rastogi, Ashu; Walia, Rama; Dutta, Pinaki; Bhansali, Anil

    2012-01-01

    Introduction: Cabergoline (CAB) is conventionally started at a dose of 0.25-0.5 mg once a week with dose escalation at 1to 3months intervals. Previously, we and others have shown that rapid escalation and high doses of CAB can lead to normalization of serum PRL as early as 8.2 weeks in 93% of the patients. We hypothesize that rapid escalation of CAB doses, may help in both the earlier normalization of PRL and also significant shrinkage of tumor mass. Study Design: Randomized, prospective, interventional trial. Subjects and Methods: Forty two patients (male or female) with macroprolactinoma were randomized to conventional (group A) or rapid escalation (group B) of CAB dosing. In group B, CAB was started at a dose of 0.5 mg twice a week followed by a weekly hike of 1 mg/week, based on serum PRL and then monthly. The end point of the present study was a composite of normoprolactinemia and tumor shrinkage ≥50% from baseline. PRL and visual field analysis (weekly), other hormonal work up periodically and magnetic resonance imaging (sella) was performed monthly. Results: A total of 19 patients in each group completed a minimum follow-up of 6 months. There was a reduction of 72.7 ± 26.2% in group A and 84.1 ± 15.0 in group B (P = 0.24) within a week of CAB therapy. The duration of CAB treatment to normalize PRL was 10.2 ± 9.2 week(2-36) in group A and 7.2 ± 6.2 weeks(1-24) in group B (P = 0.28). There was no difference in the tumor shrinkage in either of the groups (92.3% [46.7-100%] in group A and 90.5% [66.6-100%] reduction in group B). The composite end point was achieved in 14 patients in group A (73.6%) and 16 patients in group B (84.2%) (P = 0.69). The composite end point was achieved in 13.1 ± 9.5 weeks (group A) versus 16.5 ± 14.1 weeks (group B) (P = 0.61). Discussion: This is first head to head comparative trial showing that a rapid hike of CAB dose is not associated with earlier normalization of PRL or reduction in tumor volume as compared to

  7. Experimental evaluation of self-efficacy treatment on technical/scientific career outcomes

    NASA Astrophysics Data System (ADS)

    Dawes, Mary Ellen

    Research literature was reviewed concerning the career choices of women, whose talents and abilities continue to be underutilized in many technical and scientific fields. Based on self-efficacy theory, it has been proposed that limited experience results in low self-efficacy beliefs and career interest in technical and scientific fields among women. This study experimentally evaluated a technology education program designed to provide mastery experiences described in self-efficacy theory and predicted to improve career decision making. Seventh and eighth grade students (n=169) were stratified on grade level and randomly assigned either to a published technology education program or to control curricula. Over a 7-week period, the experimental program attempted to foster exploration and performance accomplishments in the students' choice of 3 (out of 21 possible) technical and scientific careers. Pre- and post-test instruments assessed technical/scientific self-efficacy and career interest. No treatment effects were found. However, a demand measure did show significantly greater valuing of the technology education program over the control curricula. It was also noted that students self-selected technology modules for study, and likely selected modules indicating their highest self-efficacy and career interest, which may have limited possible findings. In future research, targeting students with the greatest discrepancy between self-efficacy and performance ability might be more definitive. It should also be noted that the technology education program incorporated elements of self-efficacy theory, but did not include all components. Additional work is necessary to evaluate self-efficacy treatment in career development.

  8. Evaluation of 5 versus 10 granulocyteaphaeresis sessions in steroid-dependent ulcerative colitis: A pilot, prospective, multicenter, randomized study

    PubMed Central

    Ricart, Elena; Esteve, Maria; Andreu, Montserrat; Casellas, Francesc; Monfort, David; Sans, Miquel; Oudovenko, Natalia; Lafuente, Raúl; Panés, Julián

    2007-01-01

    AIM: To evaluate the efficacy of 5 compared to 10 granulocyteaphaeresis sessions in patients with active steroid-dependent ulcerative colitis. METHODS: In this pilot, prospective, multicenter randomized trial, 20 patients with moderately active steroid-dependent ulcerative colitis were randomized to 5 or 10 granulocyteaphaeresis sessions. The primary objective was clinical remission at wk 17. Secondary measures included endoscopic remission and steroid consumption. RESULTS: Nine patients were randomized to 5 granulocyteaphaeresis sessions (group 1) and 11 patients to 10 granulocyteaphaeresis sessions (group 2). At wk 17, 37.5% of patients in group 1 and 45.45% of patients in group 2 were in clinical remission. Clinical remission was accompanied by endoscopic remission in all cases. Eighty-six percent of patients achieving remission were steroid-free at wk 17. Daily steroid requirements were significantly lower in group 2. Eighty-nine per cent of patients remained in remission during a one year follow-up. One serious adverse event, not related to the study therapy, was reported. CONCLUSION: Granulocyteaphaeresis is safe and effective for the treatment of steroid-dependent ulcerative colitis. In this population, increasing the number of aphaeresis sessions is not associated with higher remission rates, but affords a significant steroid-sparing effect. PMID:17465500

  9. Evaluating the efficacy of a chemistry video game

    NASA Astrophysics Data System (ADS)

    Shapiro, Marina

    A quasi-experimental design pre-test/post-test intervention study utilizing a within group analysis was conducted with 45 undergraduate college chemistry students that investigated the effect of implementing a game-based learning environment into an undergraduate college chemistry course in order to learn if serious educational games (SEGs) can be used to achieve knowledge gains of complex chemistry concepts and to achieve increase in students' positive attitude toward chemistry. To evaluate if students learn chemistry concepts by participating in a chemistry game-based learning environment, a one-way repeated measures analysis of variance (ANOVA) was conducted across three time points (pre-test, post-test, delayed post-test which were chemistry content exams). Results showed that there was an increase in exam scores over time. The results of the ANOVA indicated a statistically significant time effect. To evaluate if students' attitude towards chemistry increased as a result of participating in a chemistry game-based learning environment a paired samples t-test was conducted using a chemistry attitudinal survey by Mahdi (2014) as the pre- and post-test. Results of the paired-samples t-test indicated that there was no significant difference in pre-attitudinal scores and post-attitudinal scores.

  10. Evaluation Of Shielding Efficacy Of A Ferrite Containing Ceramic Material

    SciTech Connect

    Verst, C.

    2015-10-12

    The shielding evaluation of the ferrite based Mitsuishi ceramic material has produced for several radiation sources and possible shielding sizes comparative dose attenuation measurements and simulated projections. High resolution gamma spectroscopy provided uncollided and scattered photon spectra at three energies, confirming theoretical estimates of the ceramic’s mass attenuation coefficient, μ/ρ. High level irradiation experiments were performed using Co-60, Cs-137, and Cf-252 sources to measure penetrating dose rates through steel, lead, concrete, and the provided ceramic slabs. The results were used to validate the radiation transport code MCNP6 which was then used to generate dose rate attenuation curves as a function of shielding material, thickness, and mass for photons and neutrons ranging in energy from 200 keV to 2 MeV.

  11. Efficacy of narrowband ultraviolet B phototherapy and levels of serum vitamin D3 in psoriasis: A prospective study

    PubMed Central

    Gupta, Aditi; Arora, Trilok Chand; Jindal, Ankur; Bhadoria, Ajeet Singh

    2016-01-01

    Introduction: Narrowband ultraviolet B phototherapy (NBUVB) is safe and effective treatment for psoriasis. Vitamin D plays an important role in pathogenesis of psoriasis. It is known that psoriasis patients have low serum 25(OH)D levels, which increase after NBUVB. We assessed serum 25(OH)D levels, its correlation with Psoriasis Area and Severity Index (PASI), and the effect of NBUVB on 25(OH)D levels among Indian psoriasis patients. Materials and Methods: A prospective study comprising 30 adults with psoriasis with no major comorbidities (PASI > 10 and off-therapy >4 weeks) was conducted. PASI was estimated at baseline among patients and repeated after receiving 12 weeks of NBUVB therapy. Thirty age and gender-matched healthy controls were recruited to compare 25(OH)D levels at baseline and at 12 weeks. Patient demographic parameters, treatment dose, duration, side effects, and its impact on 25(OH)D levels and PASI were serially evaluated. Results: A total of 30 patients presenting with psoriasis and 30 healthy controls were enrolled in the study. Mean baseline PASI (M: F =19:11) among patients with mean age 36.8 (±7.7) years was 20.5 (±6.3) and all patients were either 25(OH)D deficient (n = 14) or insufficient (n = 16). Their baseline 25(OH)D levels were significantly lower than controls (25.93 nmol/L vs 47.54 nmol/L; P < 0.001). After NBUVB therapy (average cumulative dose 20.76 ± 7.1 J/cm2; average treatment sessions 32.57 ± 1.9), there was a significant improvement in PASI as well as 25(OH)D (P < 0.05). There was no correlation between the mean improvement in PASI and 25(OH)D after 12 weeks of therapy. Twelve (40%) patients had therapy-related side effects [pruritus (n = 8), erythema (n = 4)], none had major side effects. Conclusion: Improvement in PASI and serum 25(OH)D levels after NBUVB in psoriasis is significant but poorly correlated with each other. Vitamin D may not be the lone mediator of the therapeutic effects of NBUVB on psoriasis. PMID

  12. Biomarker Evaluation Does Not Confirm Efficacy of Computer-Tailored Nutrition Education

    ERIC Educational Resources Information Center

    Kroeze, Willemieke; Dagnelie, Pieter C.; Heymans, Martijn W.; Oenema, Anke; Brug, Johannes

    2011-01-01

    Objective: To evaluate the efficacy of computer-tailored nutrition education with objective outcome measures. Design: A 3-group randomized, controlled trial with posttests at 1 and 6 months post-intervention. Setting: Worksites and 2 neighborhoods in the urban area of Rotterdam. Participants: A convenience sample of healthy Dutch adults (n = 442).…

  13. Core Self-Evaluations, Career Decision Self-Efficacy, and Vocational Identity among Greek Adolescents

    ERIC Educational Resources Information Center

    Koumoundourou, Georgia A.; Kounenou, Kalliopi; Siavara, Eftyxia

    2012-01-01

    This study explored the mediating role of career decision self-efficacy between core self-evaluations (CSE), a newly established construct within the personality domain, and adolescents' vocational identity. Using a sample of 200 Greek high school students, it was found that for female adolescents CSE influenced vocational identity both directly…

  14. Self-Efficacy, Self-Evaluation, and Music Performance of Secondary-Level Band Students

    ERIC Educational Resources Information Center

    Hewitt, Michael P.

    2015-01-01

    In the present study, relationships between two components of self-regulation (self-efficacy and self-evaluation) and gender, school level, instrument family, and music performance were examined. Participants were 340 middle and high school band students who participated in one of two summer music camps or who were members of a private middle…

  15. Ground-based spectral reflectance measurements for efficacy evaluation of aerially applied glyphosate treatments

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Aerial application of herbicides is a common tool in agricultural field management. The objective of this study was to evaluate the efficacy of glyphosate herbicide applied aerially with both conventional and emerging aerial nozzle technologies. A Texas A&M University Plantation weed field was set u...

  16. Ground-based spectral reflectance measurements for evaluating the efficacy of aerially-applied glyphosate treatments

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Aerial application of herbicides is a common tool in agricultural field management. The objective of this study was to evaluate the efficacy of glyphosate herbicide applied aerially with both conventional and emerging aerial nozzle technologies. A Texas A&M University Plantation weed field was set...

  17. Evaluating treatment efficacy in commercial food facilities: Insights gained from small-scale simulated warehouse experiments

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Although critical to a successful IPM program, it is challenging to evaluate treatment efficacy in commercial food facilities because of the inability to obtain absolute estimates of insect population levels. These populations are spatial fragmented and occupy cryptic habitats such as equipment, pa...

  18. Evaluating Treatment Efficacy in Commercial Food Facilities: Insights Gained from Small-Scale Simulated Warehouse Experiments

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Although critical to a successful IPM program, it is challenging to evaluate treatment efficacy in commercial food facilities because of the inability to obtain absolute estimates of insect population levels. These populations are spatially fragmented and occupy cryptic habitats, such as equipment,...

  19. Using Small-Scale Randomized Controlled Trials to Evaluate the Efficacy of New Curricular Materials

    ERIC Educational Resources Information Center

    Drits-Esser, Dina; Bass, Kristin M.; Stark, Louisa A.

    2014-01-01

    How can researchers in K-12 contexts stay true to the principles of rigorous evaluation designs within the constraints of classroom settings and limited funding? This paper explores this question by presenting a small-scale randomized controlled trial (RCT) designed to test the efficacy of curricular supplemental materials on epigenetics. The…

  20. Evaluation of the Efficacy of a Dental Plaque Control Program in Autistic Patients

    ERIC Educational Resources Information Center

    Dias, Guilherme G.; Prado, Eliane F. G. B.; Vadasz, Estevao; Siqueira, Jose Tadeu T.

    2010-01-01

    The aim of this study was to verify the efficacy of a programme for dental plaque control in autistics. Patients were evaluated on five occasions over a period of 180 days using the following instruments: OHI-S, DMF-T, the Fonnes brushing technique and diet questionnaire. Participants were divided into two groups according to level of co-operation…

  1. EVALUATING THE POTENTIAL EFFICACY OF AN ANTIMICROBIAL-CONTAINING SEALANT ON DUCT LINER AND GALVANIZED STEEL

    EPA Science Inventory

    The article gives results of an evaluation of the potential efficacy of an antimicrobial-containing sealant on fibrous-glass duct liner (FGDL) and galvanized steel (GS) as used in heating, ventilating, and air-conditioning (HVAC) systems. HVAC systems become dirty to various degr...

  2. Efficacy evaluation of selected herbicides on weed control and productivity evaluation of Bt cotton in Punjab.

    PubMed

    Singh, Kulvir; Rathore, Pankaj

    2015-07-01

    Field experiments were conducted during Kharif 2012 and 2013 to evaluate the efficacy of different herbicides for weed management in cotton. Highest seed cotton yield (3537.3 kg ha(-1)) was recorded in weed free plots followed by pendimethalin @1.0 kg a.i ha(-1) as Pre.em.+quizalofopethyl @50 g a.i ha(-1) post-em at 2-4 weed leaf stage + one hoeing (3318.9 kg ha") owing to improved number of bolls per plant and boll weight. Statistically least yield was recorded underweedy check (1435.4 kg ha(-1)). Application of pyrithiobac sodium could not express any visible toxic effect on crop indicating its selectivity for cotton, although none of the tested new chemicals i.e., pyrithiobac sodium@ 62.5g a.i ha(-1) and quizalofopethyl @50g a.i ha(-1) when applied alone could not outperform the existing recommended chemicals for weed management. Yield losses to the extent of 6.2-59.4% were recorded due to weed competition. Weed control efficiency (WCE) was highest under weed free check (86.8%) followed by pendimethalin @1.0 kg a.i ha(-1) as Pre. em.+quizalofopethyl @50g a.i ha(-1), at 2-4 weed leaf stage + one hoeing (73.7%), whereas minimum values were for weedy check (24.7%). Though net returns (r94660 ha(-1)) were highest for weed free check but higher B:C ratio (2:11) was observed for pendimethalin @1.0 kg a.i ha(-1) as Pre em.+quizalofopethyl @50 g a.i ha(-1) post-em at 2-4 weed leaf stage+one hoeing. Therefore, for reasons such as labor shortage besides their timely availability, using these herbicides in combination with cultural practices could be the practical solution foreconomically efficient and effective weed management.

  3. [Impact on evaluation of clinical efficacy of traditional Chinese medicine for level in soft targets of processing technology].

    PubMed

    Shao, Ming-Yi; Wei, Ming; Yan, Bo-Hua

    2014-04-01

    Traditional Chinese medicine (TCM) is a very practical subject, which has its unique theoretical system and clinical characteristics. In the course of clinical practice, the exact clinical efficacy is the key of existence and development. But the existing evaluation system is difficult to objectively evaluate the clinical efficacy of TCM. Therefore, how to objectively evaluate the clinical efficacy and get definitive evidence is the focus of the evaluation of clinical efficacy of TCM. Relative to modern medicine, TCM is more concerned about the changes of feelings and clinical symptoms of the patient in the course of the evolution of the disease. Soft targets mainly used for the evaluation of the clinical efficacy of symptoms and functional activity of the disease. The level in soft targets of processing technology is often used methods in clinical evaluation. But it has often produced the phenomenon which the results of the evaluation is mutual contradiction, which will ultimately affect the effect of evaluation of clinical efficacy of TCM. In order to better evaluate the clinical efficacy of TCM, in the process of adoption of soft targets, it clearly identify it's role, highlighting the characteristics of interventions on disease, and as much as possibly avoid the level in soft targets of processing technology to real assess clinical efficacy of TCM.

  4. Evaluation of Efficacy of Intraligamentary Injection Technique for Extraction of Mandibular Teeth-A Prospective Study

    PubMed Central

    Pradhan, Raunak; Kulkarni, Deepak

    2017-01-01

    Introduction Fear of dental pain is one of the most common reasons for delaying dental treatment. Local Anaesthesia (LA) is the most commonly employed technique of achieving pain control in dentistry. Pterygomandibular Nerve Block (PNB), for achieving mandibular anaesthesia has been the traditional technique used and is associated with a few set of complications which include pain, nerve injury, trismus, and rarely facial nerve palsy, and sustained soft tissue anaesthesia. These complications have resulted in a rapid need for research on alternative local anaesthetic techniques. Aim This study was undertaken with the objective to determine pain, duration, profoundness and complications associated with administration of Intraligamentary Injection Technique (ILT). Materials and Methods This study was conducted on 194 patients (male=122, female=72) who reported for dental extractions in mandibular posteriors. The ILT was administered with ligajet intraligamentary jet injector using cartridge containing lignocaine hydrochloride 2% with adrenaline 1:80000 and a 30 gauge needle at buccal (mesiobuccal), lingual, mesial and distal aspect of the mandibular molars. The data was analyzed by using statistical computer software SPSS 11.0 (Statistical package for social sciences 11.O version of SPSS Inc.). Median was derived for Pain on Injection (PI) and Pain during Procedure (PP). Mean and standard deviation was derived for Duration of Anaesthesia (DA). Results Various advantages were seen such as, localized soft tissue anaesthesia, decreased PI (SD=0.83), and minimal PP (SD=0.94). The DA (SD=4.62) and mean value of 24.06 minutes. Conclusion This study is one of its kinds where intraligamentary injection has been used for extraction of mandibular molars. It was also successfully used in patients with exaggerated gag reflex and patients suffering from trismus due to oral submucous fibrosis. The intraligamentary injection technique can thus be used effectively to anaesthetize mandibular molars, as a primary technique for extraction of mandibular posterior teeth. PMID:28274058

  5. Evaluation of breast cancer chemotherapy efficacy with multifractal spectrum analysis of magnetic resonance image.

    PubMed

    Li, Li; Hu, Wen-yong; Liu, Li-zhi; Pang, Ya-chun; Shao, Yuan-zhi

    2014-01-01

    Multifractal spectrum analysis of dynamic contrast enhanced (DCE) breast MR images was used to establish a new quantitative analysis method for solid tumor blood perfusion and to explore its applicability in evaluating efficacy of breast cancer chemotherapy. Five randomly selected patients suffering from newly diagnosed malignant breast nodule lesions were enrolled in this study, and four of them were treated with neoadjuvant chemotherapy. Their DCE breast MR images were collected before and after treatment. Chemotherapeutic efficacy was analyzed using international response evaluation criteria for solid tumors (RECIST). Sandbox method for statistical number density was employed to measure and calculate multifractal spectra of DCE breast MR images with spatiotemporal characteristics. Multifractal spectral data of malignant lesions before and after chemotherapy were compared. Multifractal spectra of malignant lesions show an asymmetric bell-shape. Chemotherapy efficacy was assessed to be partial remission (PR) for three patients and their multifractal spectral width significantly increased after chemotherapy while to be stable disease (SD) for other patient and of her changed slightly. Multifractal spectral width correlates with blood-supply condition of tumor lesion before and after chemotherapy, providing a potential suitable characteristic parameter for evaluating chemotherapeutic efficacy quantitatively.

  6. Palonosetron has superior prophylactic antiemetic efficacy compared with ondansetron or ramosetron in high-risk patients undergoing laparoscopic surgery: a prospective, randomized, double-blinded study

    PubMed Central

    Kim, Sung-Hoon; Hong, Jeong-Yeon; Kim, Won Oak; Karm, Myong-Hwan; Hwang, Jai-Hyun

    2013-01-01

    Background Postoperative nausea and vomiting (PONV) continues to be a major problem, because PONV is associated with delayed recovery and prolonged hospital stay. Although the PONV guidelines recommended the use of 5-hydroxy-tryptamine (5-HT3) receptor antagonists as the first-line prophylactic agents in patients categorized as high-risk, there are few studies comparing the efficacies of ondansetron, ramosetron, and palonosetron. The aim of present study was to compare the prophylactic antiemetic efficacies of three 5HT3 receptor antagonists in high-risk patients after laparoscopic surgery. Methods In this prospective, randomized, double-blinded trial, 109 female nonsmokers scheduled for elective laparoscopic surgery were randomized to receive intravenous 4 mg ondansetron (n = 35), 0.3 mg ramosetron (n = 38), or 75 µg palonosetron (n = 36) before anesthesia. Fentanyl-based intravenous patient-controlled analgesia was administered for 48 h after surgery. Primary antiemetic efficacy variables were the incidence and severity of nausea, the frequency of emetic episodes during the first 48 h after surgery, and the need to use a rescue antiemetic medication. Results The overall incidence of nausea/retching/vomiting was lower in the palonosetron (22.2%/11.1%/5.6%) than in the ondansetron (77.1%/48.6%/28.6%) and ramosetron (60.5%/28.9%/18.4%) groups. The rescue antiemetic therapy was required less frequently in the palonosetron group than the other groups (P < 0.001). Kaplan-Meier analysis showed that the order of prophylactic efficacy in delaying the interval to use of a rescue emetic was palonosetron, ramosetron, and ondansetron. Conclusions Single-dose palonosetron is the prophylactic antiemetics of choice in high-risk patients undergoing laparoscopic surgery. PMID:23814652

  7. A Prospective, Randomized, Masked, and Placebo-Controlled Efficacy Study of Intraarticular Allogeneic Adipose Stem Cells for the Treatment of Osteoarthritis in Dogs

    PubMed Central

    Harman, Robert; Carlson, Kim; Gaynor, Jamie; Gustafson, Scott; Dhupa, Sarit; Clement, Keith; Hoelzler, Michael; McCarthy, Tim; Schwartz, Pamela; Adams, Cheryl

    2016-01-01

    Osteoarthritis (OA) is a degenerative joint disease with a high prevalence in dogs. Mesenchymal stem cells (MSCs) have been used to treat humans, dogs, and horses with OA. This report describes a prospective, randomized, blinded, and placebo-controlled clinical efficacy study of intraarticular allogeneic adipose stem cells for the treatment of dogs with OA. Health assessments and measurements of pain and activity impairment were performed at baseline and at selected time points through day 60. The primary outcome variable was the owner Client-Specific Outcome Measurement (CSOM) and secondary measures included veterinary pain on manipulation, veterinary global score, and owner global score. The dogs were treated with either a saline placebo or a single dose of allogeneic adipose-derived MSCs in either one or two joints. Seventy-four dogs were statistically analyzed for efficacy outcomes. Success in the primary outcome variable, CSOM, was statistically improved in the treated dogs compared to the placebo dogs (79.2 versus 55.4%, p = 0.029). The veterinary pain on manipulation score (92.8 versus 50.2%, p = 0.017) and the veterinary global score (86.9 versus 30.8%, p = 0.009) were both statistically improved in treated dogs compared to placebo. There was no detected significant difference between treated and placebo dogs in the incidence of adverse events or negative health findings. Allogeneic adipose-derived stem cell treatment was shown to be efficacious compared to placebo. This large study of dogs also provides valuable animal clinical safety and efficacy outcome data to our colleagues developing human stem cell therapy. PMID:27695698

  8. Using Self-Efficacy as a Construct for Evaluating Science and Mathematics Methods Courses

    NASA Astrophysics Data System (ADS)

    Brand, Brenda R.; Wilkins, Jesse L. M.

    2007-04-01

    The focus of this study was elementary preservice teachers’ development as effective teachers of science and mathematics as influenced by their participation in elementary science and mathematics methods courses. Preservice teachers’ reports of factors that influenced their perception of their teaching abilities were analyzed according to Bandura’s (1994) 4 sources of efficacy: mastery experiences, vicarious experiences, social persuasion, and stress reduction. This investigation allowed the researchers to evaluate the courses based on these sources. The analysis indicated all 4 sources influenced preservice teachers’ teaching self-efficacy beliefs, with mastery experiences considered the most influential. Embedded within discussions of mastery experiences were references to the other sources of efficacy, which suggest an interrelationship between mastery experiences and the other sources.

  9. Searching for control: priming randomness increases the evaluation of ritual efficacy.

    PubMed

    Legare, Cristine H; Souza, André L

    2014-01-01

    Reestablishing feelings of control after experiencing uncertainty has long been considered a fundamental motive for human behavior. We propose that rituals (i.e., socially stipulated, causally opaque practices) provide a means for coping with the aversive feelings associated with randomness due to the perception of a connection between ritual action and a desired outcome. Two experiments were conducted (one in Brazil [n = 40] and another in the United States [n = 94]) to evaluate how the perceived efficacy of rituals is affected by feelings of randomness. In a between-subjects design, the Scramble Sentence Task was used as a priming procedure in three conditions (i.e., randomness, negativity, and neutral) and participants were then asked to rate the efficacy of rituals used for problem-solving purposes. The results demonstrate that priming randomness increased participants' perception of ritual efficacy relative to negativity and neutral conditions. Implications for increasing our understanding of the relationship between perceived control and ritualistic behavior are discussed.

  10. Efficacy and safety of botulinum toxin type A (Dysport) for the treatment of post-stroke arm spasticity: results of the German-Austrian open-label post-marketing surveillance prospective study.

    PubMed

    Jost, Wolfgang H; Hefter, Harald; Reissig, Andrea; Kollewe, Katja; Wissel, Joerg

    2014-02-15

    The current practice in Germany and Austria, and the safety and efficacy of botulinum toxin type A (BoNT-A; Dysport) in the treatment of patients with post-stroke arm spasticity (with no fixed upper-limb contractures), were assessed in this observational prospective non-interventional study. One treatment cycle was documented with assessments at baseline, approximately week 4 (optional), and approximately week 12. Pattern of spasticity, treatment goal, safety and efficacy were recorded. Overall response and goal achievement was rated on a 4-point scale ('no goal achievement', 'goal achievement', 'good goal achievement', 'best goal achievement'). In total, 409 patients were included and 99% assigned to one of five arm-spasticity patterns. Therapy goals included reduced muscle tone (92.6%), physiotherapy or occupational therapy support (63.8%), increased range of motion (61.8%), pain reduction (58.9%), facilitation of care or hygiene (55.7%), and functional improvement (17.0%). Goals were achieved in 84% of patients. The following factors had the most potential as predictors of treatment outcome: pre-treatment; time since onset of spasticity; pattern of arm spasticity. Mean Dysport dose was 728 U and an inverse dose-response relationship was observed. Treatment was well tolerated. 500-1000 U was a safe and effective treatment for post-stroke arm spasticity in this post-marketing evaluation.

  11. Efficacy and tolerance of repeated oral doses of tolperisone hydrochloride in the treatment of painful reflex muscle spasm: results of a prospective placebo-controlled double-blind trial.

    PubMed

    Pratzel, H G; Alken, R G; Ramm, S

    1996-10-01

    The efficacy and safety of oral tolperisone hydrochloride (Mydocalm) in the treatment of painful reflex muscle spasm was assessed in a prospective, randomized, double-blind, placebo-controlled trial. A total of 138 patients, aged between 20 and 75 years, with painful reflex muscle spasm associated with diseases of the spinal column or proximal joints were enrolled in eight rehabilitation centers. Patients were randomized to receive either 300 mg tolperisone hydrochloride or placebo for a period of 21 days. Both treatment groups recovered during the 3 weeks rehabilitation program. However, tolperisone hydrochloride proved to be significantly superior to placebo: the change score of the pressure pain threshold as the primary target parameter significantly increased during therapy with tolperisone hydrochloride (P = 0.03, valid-case-analysis) compared to the results obtained on placebo treatment. The overall assessment of efficacy by the patient also demonstrated significant differences in favor of tolperisone hydrochloride. Best results were seen in patients aged between 40 and 60 years with a history of complaints shorter than 1 year and with concomitant physical therapy. The evaluation of safety data, i.e., adverse events, biochemical and hematological laboratory parameters, demonstrated no differences between tolperisone hydrochloride and placebo. As a conclusion tolperisone hydrochloride represents an effective and safe treatment of painful reflex muscle spasm without the typical side effects of centrally active muscle relaxants.

  12. Psychosocial characteristics of candidates for the prospective evaluation of radial keratotomy (PERK) study.

    PubMed

    Bourque, L B; Rubenstein, R; Cosand, B; Waring, G O; Moffitt, S; Gelender, H; Laibson, P R; Lindstrom, R L; McDonald, M; Myers, W D

    1984-08-01

    The National Eye Institute Prospective Evaluation of Radial Keratotomy (PERK) Study is a multicenter clinical trial for the evaluation of radial keratotomy. This article describes the questionnaire data collected on PERK patients and compares them with a similar group of myopic persons studied during the Rand Health Insurance Experiment (heretofore referred to as the Rand study). The PERK patients are young, white myopes who dislike being dependent on corrective lenses but perceive themselves to be more visually impaired than do comparable Rand study myopes. Most female subjects and a plurality of the male subjects have tried contact lenses and quit wearing them mainly because use of the lenses was inconvenient or bothersome. There is no evidence that patients are psychologically or socially deviant. Both male and female subjects expressed a fear of being without vision and cited impatience with the lenses as their major motivation for wanting surgery.

  13. Long-term prospective evaluation of intestinal anastomosis using stainless steel staples in 14 dogs.

    PubMed

    Benlloch-Gonzalez, Manuel; Gomes, Eymeric; Bouvy, Bernard; Poncet, Cyrill

    2015-07-01

    This prospective clinical study evaluated the use, complications, and clinical and ultrasonographic follow-ups of end-to-end intestinal anastomoses with skin staples in naturally occurring diseases in canine small and large intestines. Intestinal anastomoses were performed in 14 dogs and pre-, peri-, and postoperative data were recorded. Postoperative clinical and ultrasound evaluations were performed at regular intervals for 1 year. The mean time taken to construct the anastomosis was 5 min. There were no intraoperative complications. Hemorrhage and colonic stricture were the main postoperative complications. Staple loss occurred in 2 cases. Absence of wall layering and focal wall thickening were observed in all cases at each ultrasonographic follow-up. Hyperechoic fat was observed in all but 1 of the cases at month 1. Nine dogs were alive with normal digestive function at the end of the study. The skin stapler technique enabled rapid construction of consistent anastomoses with inexpensive stapling material.

  14. Effects of individualized bone density feedback and educational interventions on osteoporosis knowledge and self-efficacy: a 12-yr prospective study.

    PubMed

    Wu, Feitong; Laslett, Laura L; Wills, Karen; Oldenburg, Brian; Jones, Graeme; Winzenberg, Tania

    2014-01-01

    This is 12-yr follow-up of a randomized controlled trial aimed to evaluate the long-term effects of bone density feedback and osteoporosis education on osteoporosis knowledge and self-efficacy. We examined the effects of feedback of bone density-defined fracture risk (high [T-score <0] vs normal [T-score ≥0] risk) and 2 different educational interventions (the group-based Osteoporosis Prevention and Self-Management Course [OPSMC] vs an osteoporosis leaflet) on osteoporosis knowledge and self-efficacy in women aged 25-44. Seventy-four percent (N = 347) of 470 participants at baseline participated at 12 yr. Overall, the scores were higher for osteoporosis knowledge but lower for self-efficacy at 12 yr. However, neither intervention had an effect on the change in knowledge (T-score, β = 0.4, 95% confidence interval [CI] = -0.3 to 1.1; OPSMC, β = 0.2, 95% CI = -0.5 to 0.9) or self-efficacy (T-score, β = -1.1, 95% CI = -2.5 to 0.4; OPSMC, β = -0.2, 95% CI = -1.6 to 1.3). Women in households with an unemployed main financial provider had a decrease in knowledge at 12 yr compared with those in households with an employed main financial provider in whom knowledge increased (β = -1.95, 95% CI = -3.40 to -0.50), but there were no other predictors of change identified for knowledge or self-efficacy. In conclusion, beneficial effects of both OPSMC and feedback of high fracture risk on osteoporosis knowledge seen previously at 2 yr were not sustained after 12 yr although overall knowledge was still significantly higher than at baseline. Neither intervention improved osteoporosis self-efficacy. More frequent osteoporosis education and bone density feedback may be required to maintain knowledge, and other approaches to improve self-efficacy are necessary.

  15. Data-Intensive Evaluation: The Concept, Methods, and Prospects of Higher Education Monitoring Evaluation

    ERIC Educational Resources Information Center

    Wang, Zhanjun; Qiao, Weifeng; Li, Jiangbo

    2016-01-01

    Higher education monitoring evaluation is a process that uses modern information technology to continually collect and deeply analyze relevant data, visually present the state of higher education, and provide an objective basis for value judgments and scientific decision making by diverse bodies Higher education monitoring evaluation is…

  16. Efficacy and Safety of Two Different n-Butyl-2-Cyanoacrylates for the Embolization of Varicoceles: A Prospective, Randomized, Blinded Study

    SciTech Connect

    Vanlangenhove, Peter Keukeleire, Katrien De; Everaert, Karel; Maele, Georges Van; Defreyne, Luc

    2012-06-15

    Purpose: This was a prospective, randomized, blinded comparative study of the efficacy and safety of two different n-butyl-2-cyanoacrylates (NBCAs) for embolization of varicoceles. Methods: A total of 112 insufficient spermatic veins (left-sided, n = 84; right-sided, n = 28) that were diagnosed in 83 adult males were prospectively randomized for blinded embolization with NBCA (n = 54; Histoacryl, Braun, Germany) or NBCA-MS (n = 58; Glubran2, General Enterprise Marketing, Viareggio, Lucca, Italy). Handling, embolic efficacy, and safety of both NBCAs were compared according the fulfillment of a standardized embolization plan, the occlusive effect on the spermatic vein, and the sticking to the microcatheter. Statistical analysis was performed with the Mann-Whitney U test and the Fisher's exact test. Results: Patients of both study arms were comparable for age and clinical indication. Spermatic vein characteristics were comparable for varicocele classification and embolization side. Both NBCAs were equally efficient in occluding the spermatic vein and blocking reflux (NBCA, n = 54/54, 100% vs. NBCA-MS, n = 54/57, 94.7%; P = 0.244). The embolization plan could be accomplished in an equal number of veins for both groups (NBCA, n = 45/54, 83.3% vs. NBCA-MS, n = 41/58, 70.7%; P = 0.124). Adhesiveness of the glue to the microcatheter was the same in both NBCA groups (NBCA, n = 25/54, 46.3% vs. NBCA-MS, n = 29/58, 50%; P = 0.71). No glue-related complications were noted. Conclusions: NBCA and NBCA-MS are equally efficient and safe glues for embolization of varicoceles.

  17. Transdermal scopolamine in the prevention of motion sickness - Evaluation of the time course of efficacy

    NASA Technical Reports Server (NTRS)

    Homick, J. L.; Reschke, M. F.; Degioanni, J.; Cintron-Trevino, N. M.; Kohl, R. L.

    1983-01-01

    This study evaluated the time course of efficacy of transdermal scopolamine in the prevention of motion sickness induced by exposure to coriolis stimulation in a rotating chair. We measured levels of efficacy, quantified side effects and symptoms, and determined inter- and intra-subject variability following use of transdermal scopolamine. The response to transdermal scopolamine was highly variable, although overall we recorded a 40 percent improvement in test scores 16-72 h after application of the transdermal system. This variability could not be explained solely by the levels of scopolamine present in the blood. The improvement was not due to the artifactual repression by scopolamine of selected symptoms of motion sickness. An unexpectedly high incidence of side effects was reported. It was concluded that the therapeutic use of transdermal scopolamine be evaluated individually and that individuals be cautioned that subsequent usage may not always be effective.

  18. Prospective performance evaluation of selected common virtual screening tools. Case study: Cyclooxygenase (COX) 1 and 2

    PubMed Central

    Kaserer, Teresa; Temml, Veronika; Kutil, Zsofia; Vanek, Tomas; Landa, Premysl; Schuster, Daniela

    2015-01-01

    Computational methods can be applied in drug development for the identification of novel lead candidates, but also for the prediction of pharmacokinetic properties and potential adverse effects, thereby aiding to prioritize and identify the most promising compounds. In principle, several techniques are available for this purpose, however, which one is the most suitable for a specific research objective still requires further investigation. Within this study, the performance of several programs, representing common virtual screening methods, was compared in a prospective manner. First, we selected top-ranked virtual screening hits from the three methods pharmacophore modeling, shape-based modeling, and docking. For comparison, these hits were then additionally predicted by external pharmacophore- and 2D similarity-based bioactivity profiling tools. Subsequently, the biological activities of the selected hits were assessed in vitro, which allowed for evaluating and comparing the prospective performance of the applied tools. Although all methods performed well, considerable differences were observed concerning hit rates, true positive and true negative hits, and hitlist composition. Our results suggest that a rational selection of the applied method represents a powerful strategy to maximize the success of a research project, tightly linked to its aims. We employed cyclooxygenase as application example, however, the focus of this study lied on highlighting the differences in the virtual screening tool performances and not in the identification of novel COX-inhibitors. PMID:25916906

  19. 77 FR 65698 - Prospective Grant of Exclusive Evaluation Option License: Pre-clinical Evaluation of Human...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-30

    ...: Pre- clinical Evaluation of Human Therapeutics Utilizing Ubiquitin Based Fusion Proteins With Apoptosis Modifying Proteins Such as BCL-XL AGENCY: National Institutes of Health, Public Health Service... an Extracellular BCL- x L Fusion Protein Inhibits Apoptosis'' (HHS Ref. No. E-073-...

  20. Evaluation of thyroid hormones in children receiving carbamazepine or valproate: a prospective study.

    PubMed

    Kafadar, İhsan; Kılıç, Betül Aydın; Arapoglu, Mujde; Yalçın, Koray; Dalgıç, Nazan

    2015-01-01

    The aim of this study was to determine the alterations in thyroid function during carbamazepine or valproate monotherapy in a prospective study. Forty patients treated with valproate, 33 patients treated with carbamazepine, and 36 control patients, all aged between 2 and 18 years, were enrolled in our study. Serum levels of thyroid hormones were measured before the beginning of the antiepileptic therapy and at 6 and 12 months of treatment. Carbamazepine-treated patients showed mean serum thyroid hormone levels significantly lower than baseline evaluation and the control group. Thyroid-stimulating hormone levels at 6 and 12 months were not significantly different in carbamazepine treated patients. Serum hormone levels did not change during valproate treatment. Thyroid-stimulating hormone levels were significantly higher at the 12th month of valproate treatment. Our data suggest that although carbamazepine causes significant alterations in thyroid hormone levels, these changes do not lead to clinical symptoms at the follow-up period of 12 months.

  1. Evaluating the prospects for sustainable energy development in a sample of Chinese villages.

    PubMed

    Mortimer, Nigel D; Grant, John F

    2008-04-01

    This paper describes the methods used to evaluate the potential for achieving sustainable energy development in six Chinese villages included in the Sustainable Users' Concepts for China Engaging Scientific Scenarios (SUCCESS) Project by examining energy efficiency potential and local renewable energy prospects. The approaches needed to obtain and analyse information on possible energy efficiency measures and renewable energy resources are summarised. Results are presented in terms of cumulative net savings in primary energy consumption, as an indicator of energy resource depletion, and associated carbon dioxide emissions, as an indicator of global climate change. Options for sustainable energy development are ranked in order of likely implementation and practical actions which could be considered in each village are identified.

  2. Virtual cystoscopy (pneumo-cystoscopy)—Its utility in the prospective evaluation of bladder tumor

    PubMed Central

    Singh, Iqbal; Mehrotra, Gopesh; Jaura, Maninder S.; Agarwal, Vivek; Tandon, Anupama; Joshi, Mohit

    2012-01-01

    Aim: To evaluate the role of virtual cystoscopy (VC) comparing it with cystopanendoscopy (CPE) for detecting bladder tumor(s). Material and Methods: Ethical clearance was obtained from the Institutional ethics committee. After an informed consent 30 patients fulfilling the inclusion criteria were enrolled in the prospective non-randomized clinical study and were evaluated as per protocol with VC performed by a qualified radiologist who was blinded to the findings of CPE performed by a qualified urologist. The results so obtained were analyzed using appropriate statistical tools. Results: The mean age of the patients was 56 years. Sensitivity of VC in detecting bladder lesions was 92%. However, when axial images were also interpreted along with VC, the sensitivity increased to 96% for detecting bladder lesions. The specificity of VC with axial CT was 40% in respect of detecting bladder lesions. VC with axial CT was 85.7% sensitive in identifying multiple bladder tumors. There were no complications on account of performing VC. Minor problems were encountered with VC and CPE in 16.7% and 13.3% patients respectively. Conclusions: VC with axial CT is 96% sensitive in detecting bladder lesions and 85.7% sensitive in detecting the multiplicity of the tumors. VC may be a useful complementary diagnostic tool for the workup of select patients with suspected bladder lesions. However, larger randomized controlled studies are needed to better define the precise clinical and diagnostic role of VC in routine practice. Settings and Design: Prospective Clinical Comparative Non Randomized Clinical Study. PMID:22919131

  3. Comparison of pelvic floor muscle strength evaluations in nulliparous and primiparous women: a prospective study

    PubMed Central

    Gameiro, Mônica Orsi; Sousa, Vanessa Oliveira; Gameiro, Luiz Felipe; Muchailh, Rosana Carneiro; Padovani, Carlos Roberto; Amaro, João Luiz

    2011-01-01

    OBJECTIVE: This study aimed to compare the pelvic floor muscle strength of nulliparous and primiparous women. METHODS: A total of 100 women were prospectively distributed into two groups: Group 1 (G1) (n = 50) included healthy nulliparous women, and Group 2 (G2) (n = 50) included healthy primiparous women. Pelvic floor muscle strength was subjectively evaluated using transvaginal digital palpation. Pelvic floor muscle strength was objectively assessed using a portable perineometer. All of the parameters were evaluated simultaneously in G1 and were evaluated in G2 during the 20th and 36th weeks of pregnancy and 45 days after delivery. RESULTS: In G2, 14 women were excluded because they left the study before the follow-up evaluation. The median age was 23 years in G1 and 22 years in G2; there was no significant difference between the groups. The average body mass index was 21.7 kg/m2 in G1 and 25.0 kg/m2 in G2; there was a significant difference between the groups (p = 0.0004). In G2, transvaginal digital palpation evaluation showed significant impairments of pelvic floor muscle strength at the 36th week of pregnancy (p = 0.0006) and 45 days after vaginal delivery (p = 0.0001) compared to G1. Objective evaluations of pelvic floor muscle strength in G2 revealed a significant decrease 45 days after vaginal delivery compared to nulliparous patients. CONCLUSION: Pregnancy and vaginal delivery may cause weakness of the pelvic floor muscles. PMID:21915489

  4. Evaluating Heat Pipe Performance in 1/6 g Acceleration: Problems and Prospects

    NASA Technical Reports Server (NTRS)

    Jaworske, Donald A.; McCollum, Timothy A.; Gibson, Marc A.; Sanzi, James L.; Sechkar, Edward A.

    2011-01-01

    Heat pipes composed of titanium and water are being considered for use in the heat rejection system of a fission power system option for lunar exploration. Placed vertically on the lunar surface, the heat pipes would operate as thermosyphons in the 1/6 g environment. The design of thermosyphons for such an application is determined, in part, by the flooding limit. Flooding is composed of two components, the thickness of the fluid film on the walls of the thermosyphon and the interaction of the fluid flow with the concurrent vapor counter flow. Both the fluid thickness contribution and interfacial shear contribution are inversely proportional to gravity. Hence, evaluating the performance of a thermosyphon in a 1 g environment on Earth may inadvertently lead to overestimating the performance of the same thermosyphon as experienced in the 1/6 g environment on the moon. Several concepts of varying complexity have been proposed for evaluating thermosyphon performance in reduced gravity, ranging from tilting the thermosyphons on Earth based on a cosine function, to flying heat pipes on a low-g aircraft. This paper summarizes the problems and prospects for evaluating thermosyphon performance in 1/6 g.

  5. A behavioural and neural evaluation of prospective decision-making under risk

    PubMed Central

    Symmonds, Mkael; Bossaerts, Peter; Dolan, Raymond J.

    2010-01-01

    Making the best choice when faced with a chain of decisions requires a person to judge both anticipated outcomes and future actions. Although economic decision-making models account for both risk and reward in single choice contexts there is a dearth of similar knowledge about sequential choice. Classical utility-based models assume that decision-makers select and follow an optimal pre-determined strategy, irrespective of the particular order in which options are presented. An alternative model involves continuously re-evaluating decision utilities, without prescribing a specific future set of choices. Here, using behavioral and functional magnetic resonance imaging (fMRI) data, we studied human subjects in a sequential choice task and use these data to compare alternative decision models of valuation and strategy selection. We provide evidence that subjects adopt a model of re-evaluating decision utilities, where available strategies are continuously updated and combined in assessing action values. We validate this model by using simultaneously-acquired fMRI data to show that sequential choice evokes a pattern of neural response consistent with a tracking of anticipated distribution of future reward, as expected in such a model. Thus, brain activity evoked at each decision point reflects the expected mean, variance and skewness of possible payoffs, consistent with the idea that sequential choice evokes a prospective evaluation of both available strategies and possible outcomes. PMID:20980595

  6. Prospective Evaluation of Intra-Articular Dextrose Prolotherapy for Treatment of Osteoarthritis in Dogs.

    PubMed

    Sherwood, J Matthew; Roush, James K; Armbrust, Laura J; Renberg, Walter C

    2017-03-14

    The objective of this study was to evaluate intra-articular dextrose prolotherapy for osteoarthritis of the elbow or stifle in dogs in a randomized, double-blind, placebo-controlled, prospective pilot study. Seventeen dogs were evaluated with 10 meeting inclusion criteria for this study. Evaluations included orthopedic exam, visual lameness scoring, Canine Brief Pain Inventory (CBPI), goniometry, kinetic gait analysis, and radiography. Initial lameness score, age, body weight, duration of lameness, and CBPI scores did not differ between groups. Change in CBPI pain severity score in the prolotherapy group from wk 6-12 was significantly less improved than in the placebo group, with no other significant differences in pain severity or pain interference scores between groups. Range of motion and radiographic scores did not differ between groups at any time. Mean kinetic forces improved in prolotherapy dogs but were not significantly different between treatment groups at any time. Although easily performed and well-tolerated, there were no statistically significant benefits of dextrose prolotherapy for treatment of osteoarthritis of the elbow and stifle in dogs. Post hoc power analysis of these sample means and standard deviations found that 29-106 animals per group would be necessary to demonstrate significant differences in kinetic forces, providing useful guidance for future studies.

  7. Longitudinal evaluation of the efficacy of heat treatment procedures against Legionella spp. in hospital water systems by using a flow cytometric assay.

    PubMed

    Allegra, Severine; Grattard, Florence; Girardot, Françoise; Riffard, Serge; Pozzetto, Bruno; Berthelot, Philippe

    2011-02-01

    Legionella spp. are frequently isolated in hospital water systems. Heat shock (30 min at 70°C) is recommended by the World Health Organization to control its multiplication. The aim of the study was to evaluate retrospectively the efficacy of heat treatments by using a flow cytometry assay (FCA) able to identify viable but nonculturable (VBNC) cells. The study included Legionella strains (L. pneumophila [3 clusters] and L. anisa [1 cluster]) isolated from four hot water circuits of different hospital buildings in Saint-Etienne, France, during a 20-year prospective surveillance. The strains recovered from the different circuits were not epidemiologically related, but the strains isolated within a same circuit over time exhibited an identical genotypic profile. After an in vitro treatment of 30 min at 70°C, the mean percentage of viable cells and VBNC cells varied from 4.6% to 71.7%. The in vitro differences in heat sensitivity were in agreement with the observed efficacy of preventive and corrective heating measures used to control water contamination. These results suggest that Legionella strains can become heat resistant after heating treatments for a long time and that flow cytometry could be helpful to check the efficacy of heat treatments on Legionella spp. and to optimize the decontamination processes applied to water systems for the control of Legionella proliferation.

  8. Evaluation of the biological efficacy of hydrogen peroxide vapour decontamination in wards of an Australian hospital.

    PubMed

    Chan, H-T; White, P; Sheorey, H; Cocks, J; Waters, M-J

    2011-10-01

    This study assessed the efficacy of a 'dry' hydrogen peroxide vapour decontamination in an Australian hospital via a two-armed study. The in vivo arm examined the baseline bacterial counts in high-touch zones within wards and evaluated the efficacy of cleaning with a neutral detergent followed by either hydrogen peroxide vapour decontamination, or a manual terminal clean with bleach or Det-Sol 500. The in vitro arm examined the efficacy of hydrogen peroxide vapour decontamination on a variety of different surfaces commonly found in the wards of an Australian hospital, deliberately seeded with a known concentration of vancomycin-resistant enterococci (VRE). All bacterial counts were evaluated by a protocol of contact plate method. In the in vivo arm, 33.3% of the high-touch areas assessed had aerobic bacterial count below the detection limit (i.e. no bacteria recoverable) post hydrogen peroxide decontamination, and in all circumstances the highest microbial density was ≤3 cfu/cm(2), while in the in vitro arm there was at least a reduction in bacterial load by a factor of 10 at all surfaces investigated. These results showed that dry hydrogen peroxide vapour room decontamination is highly effective on a range of surfaces, although the cleanliness data obtained by these methods cannot be easily compared among the different surfaces as recovery of organisms is affected by the nature of the surface.

  9. A Method for Evaluating Insecticide Efficacy against Bed Bug, Cimex lectularius, Eggs and First Instars.

    PubMed

    Campbell, Brittany E; Miller, Dini M

    2017-03-15

    Standard toxicity evaluations of insecticides against insect pests are primarily conducted on adult insects. Evaluations are based on a dose-response or concentration-response curve, where mortality increases as the dose or concentration of an insecticide is increased. Standard lethal concentration (LC50) and lethal dose (LD50) tests that result in 50% mortality of a test population can be challenging for evaluating toxicity of insecticides against non-adult insect life stages, such as eggs and early instar or nymphal stages. However, this information is essential for understanding insecticide efficacy in all bed bug life stages, which affects control and treatment efforts. This protocol uses a standard dipping bioassay modified for bed bug eggs and a contact insecticidal assay for treating nymphal first instars. These assays produce a concentration-response curve to further quantify LC50 values for insecticide evaluations.

  10. Rodent Preclinical Models for Developing Novel Antiarthritic Molecules: Comparative Biology and Preferred Methods for Evaluating Efficacy

    PubMed Central

    Bolon, Brad; Stolina, Marina; King, Caroline; Middleton, Scot; Gasser, Jill; Zack, Debra; Feige, Ulrich

    2011-01-01

    Rodent models of immune-mediated arthritis (RMIA) are the conventional approach to evaluating mechanisms of inflammatory joint disease and the comparative efficacy of antiarthritic agents. Rat adjuvant-induced (AIA), collagen-induced (CIA), and streptococcal cell wall-induced (SCW) arthritides are preferred models of the joint pathology that occurs in human rheumatoid arthritis (RA). Lesions of AIA are most severe and consistent; structural and immunological changes of CIA best resemble RA. Lesion extent and severity in RMIA depends on experimental methodology (inciting agent, adjuvant, etc.) and individual physiologic parameters (age, genetics, hormonal status, etc.). The effectiveness of antiarthritic molecules varies with the agent, therapeutic regimen, and choice of RMIA. All RMIA are driven by overactivity of proinflammatory pathways, but the dominant molecules differ among the models. Hence, as with the human clinical experience, the efficacy of various antiarthritic molecules differs among RMIA, especially when the agent is a specific cytokine inhibitor. PMID:21253435

  11. Neuroplasticity and second messenger pathways in antidepressant efficacy: pharmacogenetic results from a prospective trial investigating treatment resistance.

    PubMed

    Fabbri, Chiara; Crisafulli, Concetta; Calati, Raffaella; Albani, Diego; Forloni, Gianluigi; Calabrò, Marco; Martines, Rosalba; Kasper, Siegfried; Zohar, Joseph; Juven-Wetzler, Alzbeta; Souery, Daniel; Montgomery, Stuart; Mendlewicz, Julien; Serretti, Alessandro

    2017-03-04

    Genes belonging to neuroplasticity, monoamine, circadian rhythm, and transcription factor pathways were investigated as modulators of antidepressant efficacy. The present study aimed (1) to replicate previous findings in an independent sample with treatment-resistant depression (TRD), and (2) to perform a pathway analysis to investigate the possible molecular mechanisms involved. 220 patients with major depressive disorder who were non-responders to a previous antidepressant were treated with venlafaxine for 4-6 weeks and in case of non-response with escitalopram for 4-6 weeks. Symptoms were assessed using the Montgomery Asberg Depression Rating Scale. The phenotypes were response and remission to venlafaxine, non-response (TRDA) and non-remission (TRDB) to neither venlafaxine nor escitalopram. 50 tag SNPs in 14 genes belonging to the pathways of interest were tested for association with phenotypes. Molecular pathways (KEGG database) that included one or more of the genes associated with the phenotypes were investigated also in the STAR*D sample. The associations between ZNF804A rs7603001 and response, CREB1 rs2254137 and remission were replicated, as well as CHL1 rs2133402 and lower risk of TRD. Other CHL1 SNPs were potential predictors of TRD (rs1516340, rs2272522, rs1516338, rs2133402). The MAPK1 rs6928 SNP was consistently associated with all the phenotypes. The protein processing in endoplasmic reticulum pathway (hsa04141) was the best pathway that may explain the mechanisms of MAPK1 involvement in antidepressant response. Signals in genes previously associated with antidepressant efficacy were confirmed for CREB1, ZNF804A and CHL1. These genes play pivotal roles in synaptic plasticity, neural activity and connectivity.

  12. A Clinical Evaluation of Efficacy and Safety of Hyaluronan Sponge with Vitamin C Versus Placebo for Scar Reduction

    PubMed Central

    Mahedia, Monali; Shah, Nilay

    2016-01-01

    Background: Scar formation after injury or surgery is a major clinical problem. Individually, hyaluronan, or hyaluronic acid (HA), and vitamin C have been shown to reduce scarring by means of different mechanisms. The authors evaluated the efficacy and safety of an HA sponge system containing an active derivative of vitamin C to determine whether the use of this product promotes healing and reduces inflammation and scarring after surgery. Methods: This double-blind, randomized, prospective study was approved by the local institutional review board. Participants who had unilateral or bilateral surgical scars more than 1 month but less than 18 months old were enrolled. Surgical scars were randomly assigned to receive placebo or HA sponge with vitamin C. Three blinded evaluators reviewed photographs of the incision lines and assessed the scars using a visual analog scale. A patient satisfaction survey was also administered. Participants were followed up at 4 weeks, 12 weeks, and 1 year. Results: Twenty-three patients were enrolled in the study. Six patients dropped out of the study, for a total of 17 patients included in final analysis. Mean (range) age of patient was 43.5 (25–67) years. Mean (range) body mass index was 27.4 (18–36.9) kg/m2. The mean visual analog scale score for scars receiving HA sponge with vitamin C was slightly lower than the scars receiving placebo, but the difference was not statistically significant (t test; P = 0.9). The HA sponge with vitamin C was found to have significant positive findings on a patient satisfaction survey. Conclusions: The HA sponge system with vitamin C is safe to use in any scars older than 4 weeks. It has high patient satisfaction in achieving a better scar after surgery. The micro-roller used to apply the product was easy to use to potentially increase the spread of the medication in older scars. PMID:27536471

  13. Prospective Multicenter Trial Evaluating Balloon-Catheter Partial-Breast Irradiation for Ductal Carcinoma in Situ

    SciTech Connect

    Abbott, Andrea M.; Portschy, Pamela R.; Lee, Chung; Le, Chap T.; Han, Linda K.; Washington, Tara; Kinney, Michael; Bretzke, Margit; Tuttle, Todd M.

    2013-11-01

    Purpose: To determine outcomes of accelerated partial-breast irradiation (APBI) with MammoSite in the treatment of ductal carcinoma in situ (DCIS) after breast-conserving surgery. Methods and Materials: We conducted a prospective, multicenter trial between 2003 and 2009. Inclusion criteria included age >18 years, core needle biopsy diagnosis of DCIS, and no prior breast cancer history. Patients underwent breast-conserving surgery plus MammoSite placement. Radiation was given twice daily for 5 days for a total of 34 Gy. Patients were evaluated for development of toxicities, cosmetic outcome, and ipsilateral breast tumor recurrence (IBTR). Results: A total of 41 patients (42 breasts) completed treatment in the study, with a median follow up of 5.3 years. Overall, 28 patients (68.3%) experienced an adverse event. Skin changes and pain were the most common adverse events. Cosmetic outcome at 6 months was judged excellent/good by 100% of physicians and by 96.8% of patients. At 12 months, 86.7% of physicians and 92.3% of patients rated the cosmetic outcome as excellent/good. Overall, 4 patients (9.8%) developed an IBTR (all DCIS), with a 5-year actuarial rate of 11.3%. All IBTRs were outside the treatment field. Among patients with IBTRs, the mean time to recurrence was 3.2 years. Conclusions: Accelerated partial-breast irradiation using MammoSite seems to provide a safe and cosmetically acceptable outcome; however, the 9.8% IBTR rate with median follow-up of 5.3 years is concerning. Prospective randomized trials are necessary before routine use of APBI for DCIS can be recommended.

  14. Prospective Evaluation for Respiratory Pathogens in Children With Sickle Cell Disease and Acute Respiratory Illness

    PubMed Central

    Srinivasan, Ashok; Wang, Winfred C.; Gaur, Aditya; Smith, Teresa; Gu, Zhengming; Kang, Guolian; Leung, Wing; Hayden, Randall T.

    2015-01-01

    Background Human rhinovirus (HRV), human coronavirus (hCoV), human bocavirus (hBoV), and human metapneumovirus (hMPV) infections in children with sickle cell disease have not been well studied. Procedure Nasopharyngeal wash specimens were prospectively collected from 60 children with sickle cell disease and acute respiratory illness, over a 1-year period. Samples were tested with multiplexed-PCR, using an automated system for nine respiratory viruses, Chlamydophila pneumoniae, Mycoplasma pneumoniae, and Bordetella pertussis. Clinical characteristics and distribution of respiratory viruses in patients with and without acute chest syndrome (ACS) were evaluated. Results A respiratory virus was detected in 47 (78%) patients. Nine (15%) patients had ACS; a respiratory virus was detected in all of them. The demographic characteristics of patients with and without ACS were similar. HRV was the most common virus, detected in 29 of 47 (62%) patients. Logistic regression showed no association between ACS and detection of HRV, hCoV, hBoV, hMPV, and other respiratory pathogens. Co-infection with at least one additional respiratory virus was seen in 14 (30%) infected patients, and was not significantly higher in patients with ACS (P=0.10). Co-infections with more than two respiratory viruses were seen in seven patients, all in patients without ACS. Bacterial pathogens were not detected. Conclusion HRV was the most common virus detected in children with sickle cell disease and acute respiratory illness, and was not associated with increased morbidity. Larger prospective studies with asymptomatic controls are needed to study the association of these emerging respiratory viruses with ACS in children with sickle cell disease. PMID:24123899

  15. Programs for the Prevention of Youth Depression: Evaluation of Efficacy, Effectiveness, and Readiness for Dissemination.

    PubMed

    Brunwasser, Steven M; Garber, Judy

    2016-01-01

    The objective of this study was to evaluate the current state of evidence of the effectiveness of depression prevention programs for youth, assess the degree to which current evidence supports broad implementation, and outline additional steps needed to close the gap between effectiveness and dissemination. We used the Society for Prevention Research's Standards of Evidence (Flay et al., 2005 ) to evaluate the degree to which existing depression prevention programs have established intervention efficacy, effectiveness, and readiness for dissemination. We reviewed all depression prevention programs for youth that have been evaluated in at least two published, randomized controlled trials in which the intervention was compared to a no-intervention control group. A total of 37 studies evaluating 11 different programs were reviewed with regard to depressive symptoms and diagnoses at postintervention and follow-up (at least 6 months). Eight programs demonstrated significant main effects on depressive symptoms relative to controls in multiple randomized controlled trials; 5 programs had at least 1 trial with significant main effects present at least 1 year postintervention. Two programs demonstrated efficacy for both depressive symptoms and depressive episodes across multiple independent trials. Regarding effectiveness, 6 programs had at least 1 study showing significant effects when delivered by endogenous service providers; 4 programs had significant effects in studies conducted independently of the program developers. Several programs have demonstrated promise in terms of efficacy, but no depression prevention program for children or adolescents as yet has garnered sufficient evidence of effectiveness under real-world conditions to warrant widespread dissemination at this time.

  16. Programs for the Prevention of Youth Depression: Evaluation of Efficacy, Effectiveness, and Readiness for Dissemination

    PubMed Central

    Brunwasser, Steven M.; Garber, Judy

    2015-01-01

    Objective To evaluate the current state of evidence of the effectiveness of depression prevention programs for youth, assess the degree to which current evidence supports broad implementation, and outline additional steps needed to close the gap between effectiveness and dissemination. Method We used the Society for Prevention Research’s Standards of Evidence (Flay et al., 2005) to evaluate the degree to which existing depression prevention programs have established intervention efficacy, effectiveness, and readiness for dissemination. We reviewed all depression prevention programs for youth that have been evaluated in at least two published, randomized controlled trials in which the intervention was compared to a no-intervention control group. A total of 37 studies evaluating 11 different programs were reviewed with regard to depressive symptoms and diagnoses post intervention and at follow-up (at least 6 months). Results Eight programs demonstrated significant main effects on depressive symptoms relative to controls in multiple RCTs; five programs had at least one trial with significant main effects present at least one year post-intervention. Two programs demonstrated efficacy for both depressive symptoms and depressive episodes across multiple independent trials. Regarding effectiveness, six programs had at least one study showing significant effects when delivered by endogenous service providers; four programs had significant effects in studies conducted independently of the program developers. Conclusions Several programs have demonstrated promise in terms of efficacy, but no depression prevention program for children or adolescents as yet has garnered sufficient evidence of effectiveness under real-world conditions to warrant widespread dissemination at this time. PMID:25933173

  17. Exploring Instructional Strategies to Develop Prospective Elementary Teachers' Children's Literature Book Evaluation Skills for Science, Ecology and Environmental Education

    ERIC Educational Resources Information Center

    Hug, J. William

    2010-01-01

    This article is an auto-ethnographic account of the development of a children's literature book critique assignment by a science teacher educator sharing instructional dilemmas and pedagogical responses. Prospective elementary teachers enrolled in an elementary school science teaching methods course in the US selected and evaluated children's…

  18. Development of a method for evaluating carbon dioxide miscible flooding prospects. Final report

    SciTech Connect

    Green, D.W.; Swift, G.W.

    1985-03-01

    Research was undertaken to develop a method of evaluating reservoirs as prospects for carbon dioxide flooding. Evaluation was to be based on a determination of miscibility pressure and displacement efficiency under idealized conditions. To reach the objective, project work was divided into five areas: (1) conducting of phase-equilibrium studies of carbon dioxide with synthetic oils; (2) application of an equation of state to simulate the phase behavior of carbon dioxide - oil systems; (3) conducting of linear displacements of crude oils and synthetic oils by carbon dioxide in a slim-tube apparatus; (4) application of the equation of state, the phase-behavior data and slim-tube data to develop a method of screening reservoirs for carbon dioxide flooding based on determination of minimum miscibility pressure and displacement efficiency; (5) development of a one-dimensional mathematical model, based on the equation of state, for application in conjunction with the results of Parts 1 to 4. The accomplishments for these five areas are discussed in five chapters. 44 references, 90 figures, 42 tables.

  19. Prospective clinical observational study evaluating gender-associated differences of preoperative pain intensity

    PubMed Central

    Tafelski, Sascha; Kerper, Léonie F; Salz, Anna-Lena; Spies, Claudia; Reuter, Eva; Nachtigall, Irit; Schäfer, Michael; Krannich, Alexander; Krampe, Henning

    2016-01-01

    Abstract Previous studies reported conflicting results concerning different pain perceptions of men and women. Recent research found higher pain levels in men after major surgery, contrasted by women after minor procedures. This trial investigates differences in self-reported preoperative pain intensity between genders before surgery. Patients were enrolled in 2011 and 2012 presenting for preoperative evaluation at the anesthesiological assessment clinic at Charité University hospital. Out of 5102 patients completing a computer-assisted self-assessment, 3042 surgical patients with any preoperative pain were included into this prospective observational clinical study. Preoperative pain intensity (0–100 VAS, visual analog scale) was evaluated integrating psychological cofactors into analysis. Women reported higher preoperative pain intensity than men with median VAS scores of 30 (25th–75th percentiles: 10–52) versus 21 (10–46) (P < 0.001). Adjusted multiple regression analysis showed that female gender remained statistically significantly associated with higher pain intensity (P < 0.001). Gender differences were consistent across several subgroups especially with varying patterns in elderly. Women scheduled for minor and moderate surgical procedures showed largest differences in overall pain compared to men. This large clinical study observed significantly higher preoperative pain intensity in female surgical patients. This gender difference was larger in the elderly potentially contradicting the current hypothesis of a primary sex-hormone derived effect. The observed variability in specific patient subgroups may help to explain heterogeneous findings of previous studies. PMID:27399095

  20. OSSE Evaluation of Prospective Aircraft Reconnaissance Flight Patterns and their Impact on Hurricane Forecasts

    NASA Astrophysics Data System (ADS)

    Ryan, K. E.; Bucci, L. R.; Christophersen, H.; Atlas, R. M.; Murillo, S.; Dodge, P.

    2015-12-01

    Each year, NOAA/AOML's Hurricane Research Division (HRD) conducts its Hurricane field Program in which observations are collected via NOAA aircraft to improve the understanding and prediction of hurricanes. Mission experiments suggest a variety of flight patterns and sampling strategies aimed towards their respective goals described by the Intensity Forecasting Experiment (IFEX; Rogers et al., BAMS, 2006, 2013), a collaborative effort among HRD, NHC, and EMC. Evaluating the potential impact of various trade-offs in design is valuable for determining the optimal air reconnaissance flight pattern for a given prospective mission. AOML's HRD has developed a system for performing regional Observing System Simulation Experiments (OSSEs) to assess the potential impact of proposed observing systems on hurricane track and intensity forecasts and analyses. This study focuses on investigating the potential impact of proposed aircraft reconnaissance observing system designs. Aircraft instrument and flight level retrievals were simulated from a regional WRF ARW Nature Run (Nolan et al., 2013) spanning 13 days, covering the life cycle of a rapidly intensifying Atlantic tropical cyclone. The aircraft trajectories are simulated in a variety of ways and are evaluated to investigate the potential impact of aircraft reconnaissance observations on hurricane track and intensity forecasts.

  1. Association of erythrocyte methotrexate-polyglutamate levels with the efficacy and hepatotoxicity of methotrexate in patients with rheumatoid arthritis: a 76-week prospective study

    PubMed Central

    Kaneko, Yuko; Okano, Yutaka; Taguchi, Hiroaki; Oshima, Hisaji; Izumi, Keisuke; Yamaoka, Kunihiro; Takeuchi, Tsutomu

    2017-01-01

    Objective To assess the utility of erythrocyte methotrexate-polyglutamate (MTX-PG) concentrations in determining the safety and efficacy of MTX in patients with rheumatoid arthritis (RA). Methods 79 MTX-naïve patients with RA were enrolled in this prospective 76-week cohort study. MTX was initiated, and a predefined dose-escalation protocol was followed. Erythrocyte MTX-PG concentrations were measured using liquid chromatography. The associations of MTX-PG concentrations with disease activity and adverse events were analysed. Results Dose escalation of MTX resulted in increased MTX-PG concentrations and a decrease in the mean Disease Activity Score in 28 joints (DAS28). A significant association was observed between total MTX-PG concentrations and ΔDAS28 at week 12 (β=−0.013, p=0.003) and at week 24 (β=−0.014, p=0.003). The maximum MTX-PG levels were significantly higher in patients presenting with elevated transaminases (≥100 IU/L) than in those without (146 vs 106 nmol/L, p=0.009). Receiver operating characteristic curve analysis revealed that a total MTX-PG concentrations of 83 nmol/L at week 12 was the threshold for a DAS28 improvement of ≥1.2 at week 24, and 105 nmol/L was the threshold for transaminases of ≥50 IU/L and 131 nmol/L for transaminases of ≥100 IU/L. MTX-PG concentrations were strongly influenced by body mass index and a serum albumin level. Conclusions MTX-PG concentrations are a useful biomarker in MTX therapy, in terms of efficacy and safety. PMID:28123781

  2. Evaluation of safety and efficacy of telmisartan-amlodipine combination in treating hypertension.

    PubMed

    Faruqui, Arif A

    2008-09-01

    The objective of this open, non-comparative, prospective postmarketing surveillance (PMS) study was to identify, validate and quantify the safety and efficacy associated with the use of fixed dose combination (FDC) of telmisartan 40 mg + amlodipine 5 mg (T40+A5) in hypertensive patients with or without concomitant diabetes. The data was collected from 72 centres from all over India during the period of June 2007 to February 2008. A total of 251 patients of either sex and those who were newly diagnosed stage II hypertension, or those who were uncontrolled on monotherapy with or without diabetes mellitus were included in this study. Patients were prescribed with T40+A5 combination orally. Systolic BP (SBP), diastolic BP (DBP) and heart rate (HR) were measured at the start and at the end of 2, 4 and 8 weeks of treatment. Primary efficacy end points were reduction in clinical SBP/ DBP from baseline to study end and number of patients achieving JNC VII goals. Tolerability was assessed by treatment-emergent adverse events. Out of 251 patients, 208 patients had completed the study (120 males and 88 females), 42 were lost to follow-up the study and one patient was withdrawn due to adverse effects. The mean age of the patients was 54.5 +/- 0.98 years for males and 52.94 +/- 1.078 years for females. Diabetes mellitus was seen in 64.9% of cases, dyslipidaemia in 2.88%, previous IHD in 7.2% cases and chronic obstructive pulmonary disease (COPD) in 0.50% of cases. Reduction in the mean SBP was found to be 12.08%, 18.92% and 22.90% at the end of 2, 4 and 8 weeks respectively (p < 0.001). Reduction in the mean DBP was found to be 10.09%, 14.55% and 17.19% at the end of 2, 4 and 8 weeks respectively (p < 0.001). At the end of the study it was found that 86.3% of the hypertensive patients and 70% diabetic hypertensive patients achieved the JNC VII recommended goals. The overall incidence of ADRs was 7.69% with headache (1.92%) and vertigo (1.44%), as the commonest side

  3. Optimization, characterization, and efficacy evaluation of 2% chitosan scaffold for tissue engineering and wound healing

    PubMed Central

    Chhabra, Priyanka; Tyagi, Priyanka; Bhatnagar, Aseem; Mittal, Gaurav; Kumar, Amit

    2016-01-01

    Objective: To develop a chitosan-based scaffold and carry out a complete comprehensive study encompassing optimization of exact chitosan strength, product characterization, toxicity evaluation, in vitro validation in cell culture experiments, and finally in vivo efficacy in animal excision wound model. Materials and Methods: Developed chitosan scaffolds (CSs) were optimized for tissue engineering and wound healing efficacy by means of microstructure, toxicity, and biocompatibility evaluation. Results: Scanning electron microscope (SEM) studies revealed that porosity of CS decreased with increase in chitosan concentration. Chemical stability and integrity of scaffolds were confirmed by Fourier transform infrared studies. Highest swelling percentage (SP) of 500% was observed in 2%, while lowest (200%) was observed in 1% CS. Reabsorption and noncytotoxic property of optimized scaffold were established by enzymatic degradation and MTT assay. Enzymatic degradation suggested 20–45% of weight loss (WL) within 14 days of incubation. Cytotoxicity analysis showed that scaffolds were noncytotoxic against normal human dermal fibroblast human dermal fibroblast cell lines. Significant cellular adherence over the scaffold surface with normal cellular morphology was confirmed using SEM analysis. In vivo efficacy evaluation was carried out by means of reduction in wound size on Sprague-Dawley rats. Sprague-Dawley rats treated with optimized scaffold showed ~ 100% wound healing in comparison to ~80% healing in betadine-treated animals within 14 days. Histological examination depicted advance re-epithelization with better organization of collagen bundle in wound area treated with 2% CS in comparison to conventional treatment or no treatment. Conclusion: This study, thus, reveals that 2% CSs were found to have a great potential in wound healing. PMID:28216954

  4. Development of an improved vaccine evaluation protocol to compare the efficacy of Newcastle disease vaccines.

    PubMed

    Cardenas-Garcia, Stivalis; Diel, Diego G; Susta, Leonardo; Lucio-Decanini, Eduardo; Yu, Qingzhong; Brown, Corrie C; Miller, Patti J; Afonso, Claudio L

    2015-03-01

    While there is typically 100% survivability in birds challenged with vNDV under experimental conditions, either with vaccines formulated with a strain homologous or heterologous (different genotype) to the challenge virus, vaccine deficiencies are often noted in the field. We have developed an improved and more stringent protocol to experimentally evaluate live NDV vaccines, and showed for the first time under experimental conditions that a statistically significant reduction in mortality can be detected with genotype matched vaccines. Using both vaccine evaluation protocols (traditional and improved), birds were challenged with a vNDV of genotype XIII and the efficacy of live heterologous (genotype II) and homologous (genotype XIII) NDV vaccines was compared. Under traditional vaccination conditions there were no differences in survival upon challenge, but the homologous vaccine induced significantly higher levels of antibodies specific to the challenge virus. With the more stringent challenge system (multiple vaccine doses and early challenge with high titers of vNDV), the birds administered the homologous vaccine had superior humoral responses, reduced clinical signs, and reduced mortality levels than those vaccinated with the heterologous vaccine. These results provide basis for the implementation of more sensitive methods to evaluate vaccine efficacy.

  5. [Rethinking clinical significance of tear osmolarity measurement for dry eye diagnosis and therapeutic efficacy evaluation].

    PubMed

    Liang, Lingyi; Ke, Hongming; Liu, Zuguo

    2014-09-01

    Increased tear osmolarity is one of the core mechanisms of dry eye and has been considered as an important diagnostic criterion, if not"gold standard", of dry eye. However, recent studies showed the limitations of tear osmolarity measurement not only in the diagnosis, but also in the therapeutic efficacy evaluation of dry eye. The clinical significance of tear osmolarity measurement has become a hot topic of argument. Herein, we review the publications on this topic and try to find the underlying causes of such argument.

  6. Evaluating the efficacies of Maximum Tolerated Dose and metronomic chemotherapies: A mathematical approach

    NASA Astrophysics Data System (ADS)

    Guiraldello, Rafael T.; Martins, Marcelo L.; Mancera, Paulo F. A.

    2016-08-01

    We present a mathematical model based on partial differential equations that is applied to understand tumor development and its response to chemotherapy. Our primary aim is to evaluate comparatively the efficacies of two chemotherapeutic protocols, Maximum Tolerated Dose (MTD) and metronomic, as well as two methods of drug delivery. Concerning therapeutic outcomes, the metronomic protocol proves more effective in prolonging the patient's life than MTD. Moreover, a uniform drug delivery method combined with the metronomic protocol is the most efficient strategy to reduce tumor density.

  7. [The efficacy of SEMS for malignant upper gastrointestinal stenosis, evaluated by a "home index"].

    PubMed

    Yonechi, M; Sato, K; Saito, Y; Yamagiwa, T; Kikuchi, T; Kamiya, T; Saito, M; Nagase, K; Kashimura, J; Ikeya, S; Endo, T; Nakayama, H; Sugai, Y

    1999-12-01

    We used a self expandable metalic stent (SEMS) on 24 patients (average age 68.6 years, 20 males, 4 females) with malignant upper gastrointestinal stenosis from August, 1997 to March, 1999. The primary diseases of the 24 patients were gastric cancer (13 cases: 54%), esophageal cancer (10 cases: 42%) and paraesophageal lymph node metastasis of breast cancer (one case: 4%). In this study, we present a "Home Index" as an indicator to evaluate a patient's quality of life, and investigated the efficacy and problem of SEMS.

  8. Serenoa repens associated with Urtica dioica (ProstaMEV) and curcumin and quercitin (FlogMEV) extracts are able to improve the efficacy of prulifloxacin in bacterial prostatitis patients: results from a prospective randomised study.

    PubMed

    Cai, Tommaso; Mazzoli, Sandra; Bechi, Adriano; Addonisio, Patrizia; Mondaini, Nicola; Pagliai, Roberto Castricchi; Bartoletti, Riccardo

    2009-06-01

    We report the results of a prospective randomised study to evaluate the therapeutic effect of Serenoa repens, Urtica dioica (ProstaMEV), quercitin and curcumin (FlogMEV) extracts associated with prulifloxacin in patients affected by chronic bacterial prostatitis (CBP). From a whole population of 284 patients, 143 patients affected by CBP [National Institutes of Health (NIH) class II prostatitis] were enrolled. All patients received prulifloxacin 600 mg daily for 14 days, in accordance with antibiogram results. Patients were split into two groups: Group A received prulifloxacin associated with ProstaMEV and FlogMEV; Group B received only antibiotic therapy. Microbiological and clinical efficacies were tested by two follow-up visits at 1 month and 6 months, respectively. Quality of life (QoL) was measured using the NIH Chronic Prostatitis Symptom Index (CPSI) and International Prostatic Symptom Score (IPSS) questionnaires. Group A comprised 106 patients and Group B comprised 37 patients. One month after treatment, 89.6% of patients who had received prulifloxacin associated with ProstaMEV and FlogMEV did not report any symptoms related to CBP, whilst only 27% of patients who received antibiotic therapy alone were recurrence-free (P < 0.0001). Significant differences were found between groups in terms of symptoms and QoL (P < 0.0001 for both). Six months after treatment, no patients in Group A had recurrence of disease whilst two patients in Group B did. Questionnaire results demonstrated statistically significant differences between groups (all P < 0.001). The association of S. repens, U. dioica (ProstaMEV), quercitin and curcumin (FlogMEV) extracts is able to improve the clinical efficacy of prulifloxacin in patients affected by CBP.

  9. Analgesic Efficacy of Nephrostomy Tract inFiltration of Bupivacaine and Ketamine after Tubeless Percutaneous Nephrolithotomy: A Prospective Randomized Trial

    PubMed Central

    Shariat Moharari, Reza; Valizade, Ali; Najafi, Atabak; Etezadi, Farhad; Hosseini, Seyed Reza; Khashayar, Patricia; Khajavi, Mohammad Reza; Mojtahedzadeh, Mojtaba

    2016-01-01

    Background: Recently, the use of ketamine as a systemic and local analgesic drug in reducing post-operative pain is studied more frequently. Objectives: The aim of the present study was to assess the analgesic efficacy of IV ketamine injection inaddition to nephrostomy tract infiltration of ketamine-bupivacaine on postoperative pain relief after tubeless percutaneous nephrolithotomy (PCNL). Patients and Methods: Patients (n = 100), with renal stone who were candidates for PCNL were randomized to five groups with 20 cases in each: Group C, 10 mL of saline solution was infiltrated into the nephrostomy tract; Group B, 10 mL of 0.25% bupivacaine was infiltrated into the nephrostomy tract; Group BK1, 10 mL of 0.25% bupivacaine plus 0.5 mg/kg ketamine was infiltrated into the nephrostomy tract; Group BK2, 10 mL of 0.25% bupivacaine plus 1.5 mg/kg ketamine was infiltrated into the nephrostomy tract; Group K, 10 mL of saline solution containing 0.5 mg/kg ketamine was intravenously administered. Post-operative pain scores were compared between groups as the primary objective. Comparison of Sedation Scores, rescue analgesic consumption, time to the first rescue analgesics administration, hemodynamic and SpO2 values were regarded as the secondary objective. Results: Mean VAS scores in the first 30 min and total analgesic consumption in the first 24 h of post-operative period were significantly lower in groups BK1 and BK2 in comparison with the other groups (P < 0.05). Also, time to first rescue analgesics administration was longer in the same groups (P < 0.05). Conclusions: Infiltration of ketamine plus bupivacaine provides superior analgesic effects in PCNL surgery compared with other methods. PMID:27642334

  10. Efficacy and safety of DALI LDL-apheresis at high blood flow rates: a prospective multicenter study.

    PubMed

    Wendler, T; Schilling, R; Lennertz, A; Sodemann, K; Kleophas, W; Messner, H; Riechers, G; Wagner, J; Keller, C; Bosch, T

    2003-01-01

    Direct adsorption of lipids (DALI) is the first LDL-apheresis method compatible with whole blood. Usually, the blood flow rate is adjusted at 60-80 ml/min, which results in session times of about 2 hr. The present study was performed to test the safety and efficacy of low-density lipoprotein cholesterol (LDL-C) and lipoprotein (a) [Lp(a)] removal by DALI at high blood flow rates in order to reduce treatment time. Thirteen chronic DALI patients in seven centers suffering from hypercholesterolemia (LDL-C 162 +/- 42 mg/dl at baseline) and coronary artery disease were treated on a weekly or biweekly basis by DALI apheresis. The blood flow rate QB was held constant for at least two sessions, respectively, and was increased from 60 to 80, 120, 160, 200, and 240 ml/min. All patients had pre-existing av-fistulas. The anticoagulation was performed by a heparin bolus plus ACD-A at a ratio of citrate:blood ranging from 1:20 to 1:90. Clinically, the sessions were well tolerated and only 26/201 sessions (12%) of the treatments were fraught with minor adverse events. Acute LDL-C reductions (derived from LDL-C levels determined by lipoprotein electrophoresis) averaged 72/66/60/53/50/48% for QB=60/80/120/160/200/240 ml/min. Lp(a) reductions were 68/67/62/60/58/56%, whereas HDL-C losses were < or =10%. Routine blood chemistries and blood cell counts remained in the normal range. Treatment times averaged 142/83/45 min at Qb=60/120/240 ml/min. On average, DALI LDL-apheresis could be performed safely and effectively at high blood flow rates up to at least 120 ml/min in patients with good blood access, which significantly reduced treatment time from 142 to 83 min (-42%).

  11. Safety and efficacy of nivolumab in the treatment of cancers: A meta-analysis of 27 prospective clinical trials.

    PubMed

    Tie, Yan; Ma, Xuelei; Zhu, Chenjing; Mao, Ye; Shen, Kai; Wei, Xiawei; Chen, Yan; Zheng, Heng

    2017-02-15

    Immune checkpoint inhibition therapy has benefited people and shown powerful anti-tumor activity during the past several years. Nivolumab, a fully human IgG4 monoclonal antibody against PD-1, is a widely studied immune checkpoint inhibitor for the treatment of cancers. To assess the safety and efficacy of nivolumab, 27 clinical trials on nivolumab were analyzed. Results showed that the summary risks of all grade adverse effects (AEs) and grade ≥3 AEs were 0.65 and 0.12. The rate of nivolumab-related death was 0.25%. The most common any grade AEs were fatigue (25.1%), rush (13.0%), pruritus (12.5%), diarrhea (12.1%), nausea (11.8%) and asthenia (10.4%). The most common grade ≥3 AEs were hypophosphatemia (only 2.3%) and lymphopenia (only 2.1%). The pooled objective response rate (ORR), 6-month progression-free survival (PFS) rate and 1-year overall survival (OS) rate were 0.26, 0.40 and 0.52, respectively. The odds ratio of ORR between PD-L1 positive and negative was 2.34 (95% CI 1.77-3.10, p < 0.0001). The odds ratios of ORR, 6-month PFS rate and 1-year OS rate between nivolumab and chemotherapeutics were 2.77 (95% CI 1.69-4.56, p < 0.0001), 1.97 (95% CI 1.02-3.81, p = 0.04) and 1.87 (95% CI 1.46-2.40, p <0.0001), respectively. In conclusion, nivolumab has durable outcomes with tolerable AEs and drug-related deaths in cancer patients. Nivolumab monotherapy has better treatment response compared with chemotherapy, whereas chemotherapeutics have significantly higher risk of adverse effects than nivolumab.

  12. Efficacy and safety of pamidronate in Modic type 1 changes: study protocol for a prospective randomized controlled clinical trial

    PubMed Central

    2014-01-01

    Background Erosive degenerative disc disease, also known as Modic type 1 changes, is usually characterized by low back pain with an inflammatory pain pattern, as seen in spondyloarthropathies. Intravenous pamidronate has proven to be effective in patients with ankylosing spondylitis who are refractory to nonsteroidal antiinflammatory drugs, and in painful bone diseases in general, such as Paget’s disease, fibrous dysplasia or vertebral fractures. We therefore hypothesize that pamidronate would be effective in treating low back pain associated with Modic type 1 changes. Methods/Design This study, called PEPTIDE (short for the French title “Etude Prospective sur l’Efficacité et la tolérance du PamidronaTe dans les dIscopathies Degeneratives Erosives”), will be a double-blind, randomized, placebo-controlled, parallel group, phase two clinical trial. A total of 48 patients will be recruited. These patients will be randomly assigned to one of the two groups, with 24 patients in each group: one group will be given pamidronate and the other a placebo. Pamidronate will be administered at a dose of 90 mg per day for two days consecutively, and every patient, irrespective of treatment group, will be given paracetamol to maintain blinding by preventing drug-induced fever. The primary outcome measure is a between-group difference of 30 points on a 100 mm Visual Analogue Scale (VAS) at three months. Secondary outcome measures are improvement in functional status and the drug’s safety. Primary and secondary outcome measures will be assessed at each visit (inclusion, at six weeks, three months, and six months). If the primary goal is not attained, the patient will be offered a rigid or semi-rigid back brace, irrespective of the treatment group. Discussion To date, only local treatments, for example intradiscal corticosteroid therapy, lumbar arthrodesis or back braces have been studied in randomized, controlled trials, with controversial results. This trial is

  13. Efficacy of post-operative analgesia after posterior lumbar instrumented fusion for degenerative disc disease: a prospective randomized comparison of epidural catheter and intravenous administration of analgesics

    PubMed Central

    Kluba, Torsten; Hofmann, Fabian; Bredanger, Sabine; Blumenstock, Gunnar; Niemeyer, Thomas

    2010-01-01

    This prospective study aimed to compare the efficacy of epidural (EDA) versus intravenous (PCA) application of analgesics after lumbar fusion. Fifty-two patients scheduled for elective posterior instrumented lumbar fusion were randomized into two groups. EDA patients received an epidural catheter intraoperatively, and administration of ropivacain and sulfentanil was started after a normal postoperative wake-up test in the recovery room area. PCA patients received intravenous opioids in the post-operative period. Differences between EDA and PCA groups in terms of patient satisfaction with respect to pain relief were not significant. Nevertheless, EDA patients reported less pain on the third day after surgery. There were significantly more side effects in the EDA group, including complete reversible loss of sensory function and motor weakness. There were no major side effects, such as infection or persisting neurological deficits, in either group. The routine use of epidural anesthesia for lumbar spine surgery has too many risks and offers very little advantage over PCA. PMID:21808704

  14. Evaluating Long-term Outcomes of NHS Stop Smoking Services (ELONS): a prospective cohort study.

    PubMed Central

    Dobbie, Fiona; Hiscock, Rosemary; Leonardi-Bee, Jo; Murray, Susan; Shahab, Lion; Aveyard, Paul; Coleman, Tim; McEwen, Andy; McRobbie, Hayden; Purves, Richard; Bauld, Linda

    2015-01-01

    BACKGROUND NHS Stop Smoking Services (SSSs) provide free at the point of use treatment for smokers who would like to stop. Since their inception in 1999 they have evolved to offer a variety of support options. Given the changes that have happened in the provision of services and the ongoing need for evidence on effectiveness, the Evaluating Long-term Outcomes for NHS Stop Smoking Services (ELONS) study was commissioned. OBJECTIVES The main aim of the study was to explore the factors that determine longer-term abstinence from smoking following intervention by SSSs. There were also a number of additional objectives. DESIGN The ELONS study was an observational study with two main stages: secondary analysis of routine data collected by SSSs and a prospective cohort study of service clients. The prospective study had additional elements on client satisfaction, well-being and longer-term nicotine replacement therapy (NRT) use. SETTING The setting for the study was SSSs in England. For the secondary analysis, routine data from 49 services were obtained. For the prospective study and its added elements, nine services were involved. The target population was clients of these services. PARTICIPANTS There were 202,804 cases included in secondary analysis and 3075 in the prospective study. INTERVENTIONS A combination of behavioural support and stop smoking medication delivered by SSS practitioners. MAIN OUTCOME MEASURES Abstinence from smoking at 4 and 52 weeks after setting a quit date, validated by a carbon monoxide (CO) breath test. RESULTS Just over 4 in 10 smokers (41%) recruited to the prospective study were biochemically validated as abstinent from smoking at 4 weeks (which was broadly comparable with findings from the secondary analysis of routine service data, where self-reported 4-week quit rates were 48%, falling to 34% when biochemical validation had occurred). At the 1-year follow-up, 8% of prospective study clients were CO validated as abstinent from smoking

  15. Work-related upper-extremity disorders: prospective evaluation of clinical and functional outcomes.

    PubMed

    Pransky, G; Benjamin, K; Himmelstein, J; Mundt, K; Morgan, W; Feuerstein, M; Koyamatsu, K; Hill-Fotouhi, C

    1999-10-01

    The purpose of this study was to describe the demographic, vocational, medical, workplace, and psychosocial characteristics of patients treated for work-related upper-extremity disorders, to document treatment patterns in a community-practice setting, and to determine which of these factors predicts subsequent employment and functional status outcomes. A questionnaire was administered by mail or telephone to 112 patients seen at the University of Massachusetts Occupational Upper Extremities Disorders Clinic and included measures of disease-specific functional status, pain, reactions to pain, employer-employee relations, and number and type of interventions used to treat the disorder. Results were compared with baseline data obtained, on average, 16 months prior to follow-up. Of the original cohort (n = 124), 112 participated in the prospective study. Although most patients reported improvement in pain severity, fear of pain, life situation, and functional status, there was little change in employment status. Patients' self-reported intentions of return to work at baseline did not predict work status at follow-up. In general, those who were employed at baseline remained employed, had a greater reduction in symptom severity over time, and were significantly more likely to report improvement in their problem than those who were unemployed. The efficacy of various interventions was examined by type, mix, and intensity (number of different interventions undergone by the patient). No positive relationship was found between these measures and employment status, self-reported change in the problem, or self-reported improvement in functional status. Significant negative relationships were found between surgery, psychotherapeutic interventions, and outcomes. This was likely to have occurred because of a selection bias toward the more chronic and severely disabled patients for these treatments. However, the relative ineffectiveness of such intensive interventions as surgery

  16. Importance of yawning in the evaluation of excessive daytime sleepiness: a prospective clinical study.

    PubMed

    Catli, Tolgahan; Acar, Mustafa; Hanci, Deniz; Arikan, Osman Kursat; Cingi, Cemal

    2015-12-01

    As a dark and not fully understood side of human nature, yawning is believed to be a signs of various physiological or pathological behaviors of human. In this study, we aimed to investigate the importance of yawning in the evaluation of sleepiness. One hundred and twenty-nine snorers who were suspected to have obstructive sleep apnea syndrome underwent polysomnography and were asked to fill the Epworth sleepiness scale. The number of yawnings of patients was counted during the day following polysomnography. Patients were stratified into two groups: those have apnea hypopnea index <5 (n = 43, group 1) and those have apnea hypopnea index >30 (n = 86, group 2). Mean duration of sleep phases, oxygen saturations, sleep efficacies, yawning frequencies and Epworth scores of the groups were compared. Correlations of yawning frequency with Epworth scores, duration of sleep phases and mean oxygen saturations were investigated. Sleep efficacies were similar between the groups (p > 0.05). Yawning frequencies in group 1 and group 2 were 43.48 and 75.76 (mean rank), respectively (p < 0.01). Mean N1, N2, N3 phase durations and oxygen saturations were significantly lower in group 2 (p < 0.01). While there was a negative correlation between yawning frequency and duration of the non-REM phases and mean oxygen saturation (r = -0.53 and r = -0.31, respectively, p < 0.05), yawning frequency was positively correlated with Epworth scores (r = 0.46, p < 0.05). In addition to the shortened phases of sleep, increased Epworth score and decreased oxygen saturation, increased yawning frequency may indicate sleep deprivation.

  17. Ultrasound and 3D Skin Imaging: Methods to Evaluate Efficacy of Striae Distensae Treatment.

    PubMed

    Bleve, Mariella; Capra, Priscilla; Pavanetto, Franca; Perugini, Paola

    2012-01-01

    Background. Over time, the striae rubra develop into striae alba that appear white, flat, and depressed. It is very important to determine the optimum striae management. In order to evaluate the effectiveness of these therapies, objective measurement tools are necessary. Objective. The aim of this study is to evaluate if ultrasonography and PRIMOS can be used to obtain an objective assessment of stretch marks type and stage; furthermore, we aim to apply these techniques to evaluate the efficacy of a topical treatment. Methods. 20 volunteers were enrolled with a two-month study. A marketed cosmetic product was used as the active over one body area. The controlateral area with stretch marks was treated with a "placebo" formulation without active, as a control. The instrumental evaluation was carried out at the beginning of the trial (baseline values or t(0)), after 1 month (t(1)), and at the end of the study (t(2)). Results. PRIMOS was able to measure and document striae distensae maturation; furthermore, ultrasound imaging permitted to visualize and diagnose the striae. Statistical analysis of skin roughness demonstrated a statistically significant reduction of Rp value only in a treated group. In fact, the Rp value represented a maximum peak height in the area selected. These results demonstrated that after two months of treatment only the striae rubra can be treated successfully. Conclusions. This work demonstrated that the 22MHz ultrasound can diagnose stretch marks; PRIMOS device can detect and measure striae distensae type and maturation. Furthermore, the high-frequency ultrasound and the 3D image device, described in this work, can be successfully employed in order to evaluate the efficacy of a topical treatment.

  18. Ultrasound and 3D Skin Imaging: Methods to Evaluate Efficacy of Striae Distensae Treatment

    PubMed Central

    Bleve, Mariella; Capra, Priscilla; Pavanetto, Franca; Perugini, Paola

    2012-01-01

    Background. Over time, the striae rubra develop into striae alba that appear white, flat, and depressed. It is very important to determine the optimum striae management. In order to evaluate the effectiveness of these therapies, objective measurement tools are necessary. Objective. The aim of this study is to evaluate if ultrasonography and PRIMOS can be used to obtain an objective assessment of stretch marks type and stage; furthermore, we aim to apply these techniques to evaluate the efficacy of a topical treatment. Methods. 20 volunteers were enrolled with a two-month study. A marketed cosmetic product was used as the active over one body area. The controlateral area with stretch marks was treated with a “placebo” formulation without active, as a control. The instrumental evaluation was carried out at the beginning of the trial (baseline values or t0), after 1 month (t1), and at the end of the study (t2). Results. PRIMOS was able to measure and document striae distensae maturation; furthermore, ultrasound imaging permitted to visualize and diagnose the striae. Statistical analysis of skin roughness demonstrated a statistically significant reduction of Rp value only in a treated group. In fact, the Rp value represented a maximum peak height in the area selected. These results demonstrated that after two months of treatment only the striae rubra can be treated successfully. Conclusions. This work demonstrated that the 22MHz ultrasound can diagnose stretch marks; PRIMOS device can detect and measure striae distensae type and maturation. Furthermore, the high-frequency ultrasound and the 3D image device, described in this work, can be successfully employed in order to evaluate the efficacy of a topical treatment. PMID:22203840

  19. Contribution to More Patient-Friendly ART Treatment: Efficacy of Continuous Low-Dose GnRH Agonist as the Only Luteal Support—Results of a Prospective, Randomized, Comparative Study

    PubMed Central

    Pirard, Céline; Loumaye, Ernest; Wyns, Christine

    2015-01-01

    Background. The aim of this pilot study was to evaluate intranasal buserelin for luteal phase support and compare its efficacy with standard vaginal progesterone in IVF/ICSI antagonist cycles. Methods. This is a prospective, randomized, open, parallel group study. Forty patients underwent ovarian hyperstimulation with human menopausal gonadotropin under pituitary inhibition with gonadotropin-releasing hormone antagonist, while ovulation trigger and luteal support were achieved using intranasal GnRH agonist (group A). Twenty patients had their cycle downregulated with buserelin and stimulated with hMG, while ovulation trigger was achieved using 10,000 IU human chorionic gonadotropin with luteal support by intravaginal progesterone (group B). Results. No difference was observed in estradiol levels. Progesterone levels on day 5 were significantly lower in group A. However, significantly higher levels of luteinizing hormone were observed in group A during the entire luteal phase. Pregnancy rates (31.4% versus 22.2%), implantation rates (22% versus 15.4%), and clinical pregnancy rates (25.7% versus 16.7%) were not statistically different between groups, although a trend towards higher rates was observed in group A. No luteal phase lasting less than 10 days was recorded in either group. Conclusion. Intranasal administration of buserelin is effective for providing luteal phase support in IVF/ICSI antagonist protocols. PMID:25945092

  20. A prospective evaluation of obesometric parameters associated with renal stone recurrence

    PubMed Central

    Bos, Derek; Dason, Shawn; Matsumoto, Edward; Pinthus, Jehonathan; Allard, Christopher

    2016-01-01

    Introduction: Our aim was to evaluate whether obesometric serum hormones and body fat distribution are associated with renal stone recurrence. Methods: We conducted a prospective cohort study of participants undergoing renal stone (RS) intervention at a single institution from November 2009–June 2010 and followed them for a median 62 months. Obesometric parameters were measured at baseline, including body mass index (BMI), fasting serum leptin and adiponectin, and proportion of visceral adipose tissue (%VAT) averaged from three fixed axial computed tomography (CT) slices. The primary study outcome was stone recurrence. Results: A total of 110 participants were enrolled. Elevated %VAT was associated RS recurrence; participants with %VAT in the highest quartile had a five-year stone-free rate of 47.1% compared to 72.2% among other participants (p=0.004). Adjusting for gender, elevated %VAT was independently predictive of renal stone recurrence among initial stone formers (n=74; hazard ratio [HR] 4.53, 95% confidence interval [CI] 1.08–19.02), but not among recurrent stone formers (n=19; HR 0.51, 95% CI 0.054–4.72). Other obesometric factors, including leptin, adiponectin, and BMI, were not significantly predictive of recurrence. Conclusions: We report a novel association between an elevated %VAT and stone recurrence. These findings may inform patient counselling and followup regimens. The metabolic basis for these findings requires further investigation. PMID:27878041

  1. Results of the prospective evaluation of radial keratotomy (PERK) study one year after surgery.

    PubMed

    Waring, G O; Lynn, M J; Gelender, H; Laibson, P R; Lindstrom, R L; Myers, W D; Obstbaum, S A; Rowsey, J J; McDonald, M B; Schanzlin, D J

    1985-02-01

    The Prospective Evaluation of Radial Keratotomy (PERK) study is a nine-center, self-controlled clinical trial of a standardized technique of radial keratotomy in 435 patients who had physiologic myopia with a preoperative refraction between -2.00 and -8.00 diopters. The surgical technique consisted of eight incisions using a diamond micrometer knife with blade length determined by intraoperative ultrasonic pachymetry and the diameter of central clear zone determined by preoperative refraction. At one year after surgery, myopia was reduced in all eyes; 60% were within +/- 1.00 diopter of emmetropia; 30% were undercorrected and 10% were overcorrected by more than 1.00 diopter (range of refraction, -4.25 to +3.38 D). Uncorrected visual acuity was 20/40 or better in 78% of eyes. The operation was most effective in eyes with a refraction between -2.00 and -4.25 diopters. Thirteen percent of patients lost one or two Snellen lines of best corrected visual acuity. However, all but three eyes could be corrected to 20/20. Ten percent of patients increased astigmatism more than 1.00 diopter. Disabling glare was not detected with a clinical glare tester, but three patients reduced their driving at night because of glare. Between six months and one year, the refraction changed by greater than 0.50 diopters in 19% of eyes.

  2. Prospective Evaluation of Criteria for Microbiological Diagnosis of Prosthetic-Joint Infection at Revision Arthroplasty

    PubMed Central

    Atkins, Bridget L.; Athanasou, Nicholas; Deeks, Jonathan J.; Crook, Derrick W. M.; Simpson, Hamish; Peto, Timothy E. A.; McLardy-Smith, Peter; Berendt, Anthony R.; Group, The Osiris Collaborative Study

    1998-01-01

    A prospective study was performed to establish criteria for the microbiological diagnosis of prosthetic joint infection at elective revision arthroplasty. Patients were treated in a multidisciplinary unit dedicated to the management and study of musculoskeletal infection. Standard multiple samples of periprosthetic tissue were obtained at surgery, Gram stained, and cultured by direct and enrichment methods. With reference to histology as the criterion standard, sensitivities, specificities, and likelihood ratios (LRs) were calculated by using different cutoffs for the diagnosis of infection. We performed revisions on 334 patients over a 17-month period, of whom 297 were evaluable. The remaining 37 were excluded because histology results were unavailable or could not be interpreted due to underlying inflammatory joint disease. There were 41 infections, with only 65% of all samples sent from infected patients being culture positive, suggesting low numbers of bacteria in the samples taken. The isolation of an indistinguishable microorganism from three or more independent specimens was highly predictive of infection (sensitivity, 65%; specificity, 99.6%; LR, 168.6), while Gram staining was less useful (sensitivity, 12%; specificity, 98%; LR, 10). A simple mathematical model was developed to predict the performance of the diagnostic test. We recommend that five or six specimens be sent, that the cutoff for a definite diagnosis of infection be three or more operative specimens that yield an indistinguishable organism, and that because of its low level of sensitivity, Gram staining should be abandoned as a diagnostic tool at elective revision arthroplasty. PMID:9738046

  3. Metabolic Evaluation in Paediatric Urolithiasis: A 4-Year Open Prospective Study

    PubMed Central

    Gajengi, Ajay Kumar R; Tanwar, Harshwardhan V; Mhaske, Sunil; Patwardhan, Sujata K

    2016-01-01

    Introduction Children with urolithiasis are associated with considerable morbidity and commonly associated with metabolic abnormalities. By treating these abnormalities stone formation is prevented. Objectives To study the metabolic risk factors of urolithiasis in children and compare them with literature. Materials and Methods In open, prospective and observational study, 75 children were evaluated from August 2010 to June 2014. In all patients’ dietary history, water intake and results of laboratory findings were recorded. All urine samples obtained from patients were without dietary restrictions. Reference paediatric 24 hour urinary parameter was used according to western literature. Results We investigated 75 patients with urolithiasis. Low urine volume was found in 49 patients which is comparable with previous studies indicating simple intervention as to increase water intake. Low calcium intake was found in 44 patients suggesting that low calcium intake is associated with higher incidence of urolithiasis due to increased intestinal oxalate absorption. Hypocalcaemia was found in 32 patients and 24 hour urinary abnormality was found in only 16 patients’. Both these finding does not support previous literature. Stone analysis finding does not correlate with urinary finding. Conclusions Low urine volume secondary to low water intake is predominant finding. Hypocalcaemia is major metabolic abnormality in contradiction to western literature. There are no nomograms for urinary excretion of Calcium, uric acid, oxalate and citrate in Indian children. Keeping the optimum blood calcium level & increased fluid intake can prevent stone formation in children. PMID:27042515

  4. Right adrenal gland prospective evaluation through transgastric endoscopic ultrasound: an alternative approach

    PubMed Central

    Figueiredo, Pedro C.; Pinto-Marques, Pedro; Almeida, Ines; Gomes, Pedro C.; Serra, David

    2016-01-01

    Background and aims: Endoscopic ultrasound (EUS) guided right adrenal gland (RAG) evaluation is frequently unsuccessful and, when feasible, requires a cumbersome maneuver through the duodenum. In our experience, the use of a recent ultrasound platform has enabled transgastric detection of the RAG with a simple maneuver. The aim of this study was to determine the RAG transgastric EUS detection rate and identify predictive factors for failure. Methods: Consecutive patients referred to EUS in a single center were prospectively included over a 6-month period. Success was defined as RAG transgastric EUS detection within 180 seconds. Logistic regression analysis was used to assess factors associated with failure. Results: Among 100 patients, the success rate for RAG transgastric EUS detection was 75 %, with a median maneuver duration of 45 seconds [interquartile range, 25 – 70 seconds]. Two incidental RAG lesions were detected. Of possible demographic and anthropometric predictive factors for failure, only age (OR 1.04; P = 0.04) was statistically significant on multivariate analysis. Conclusions: The transgastric EUS approach for RAG detection is simple, fast and effective. PMID:27853745

  5. Bone marrow fibrosis in myelodysplastic syndromes: a prospective evaluation including mutational analysis

    PubMed Central

    Ramos, Fernando; Robledo, Cristina; Izquierdo-García, Francisco Miguel; Suárez-Vilela, Dimas; Benito, Rocío; Fuertes, Marta; Insunza, Andrés; Barragán, Eva; del Rey, Mónica; de Morales, José María García-Ruiz; Tormo, Mar; Salido, Eduardo; Zamora, Lurdes; Pedro, Carmen; Sánchez-del-Real, Javier; Díez-Campelo, María; del Cañizo, Consuelo; Sanz, Guillermo F.; Hernández-Rivas, Jesús María

    2016-01-01

    The biological and molecular events that underlie bone marrow fibrosis in patients with myelodysplastic syndromes are poorly understood, and its prognostic role in the era of the Revised International Prognostic Scoring System (IPSS-R) is not yet fully determined. We have evaluated the clinical and biological events that underlie bone marrow fibrotic changes, as well as its prognostic role, in a well-characterized prospective patient cohort (n=77) of primary MDS patients. The degree of marrow fibrosis was linked to parameters of erythropoietic failure, marrow cellularity, p53 protein accumulation, WT1 gene expression, and serum levels of CXCL9 and CXCL10, but not to other covariates including the IPSS-R score. The presence of bone marrow fibrosis grade 2 or higher was associated with the presence of mutations in cohesin complex genes (31.5% vs. 5.4%, p=0.006). By contrast, mutations in CALR, JAK2, PDGFRA, PDGFRB, and TP53 were very rare. Survival analysis showed that marrow fibrosis grade 2 or higher was a relevant significant predictor for of overall survival, and independent of age, performance status, and IPSS-R score in multivariate analysis. PMID:27127180

  6. Emergency Department redirection to primary care: a prospective evaluation of practice.

    PubMed

    Bentley, James A; Thakore, Shobhan; Morrison, William; Wang, Weijie

    2017-02-01

    Background and aim Non-urgent Emergency Department presentations contribute to overcrowding, which can adversely affect patient care. Redirecting patients to a more appropriate service is an option to help address this. We conducted a prospective evaluation of a major Scottish hospital's Emergency Department redirection policy to assess its safety. Methods and results Over two months, 620 patients triggered senior assessment for redirection with 444 (72%) redirected to primary care. Information on presentation was collected with subsequent management and outcome of redirection provided by the patient's general practitioner. Those who required admission within seven days of redirection triggered review. This was carried out independently by an Emergency Department Consultant and a GP Principal to assess the incidence of sub-optimal care or harm as a consequence of redirection. Most patients presented during daytime hours with no significant variation between days. 'Patient factors' accounted for 74% of presentations with 'convenience' (20%) cited as the most common reason. Twenty-two patients were subsequently admitted, with one case of sub-optimal care (incidence 0.23%) and no cases of harm. Conclusions Our redirection policy provides a safe and effective means of directing patients to more appropriate care. The authors believe this to be in the patient s best interest as Emergency Department clinicians are not specifically trained to manage primary care issues.

  7. Genital heat stress in men of barren couples: a prospective evaluation by means of a questionnaire.

    PubMed

    Jung, A; Schill, W-B; Schuppe, H-C

    2002-12-01

    Exposure to genital heat stress among men of barren couples was evaluated in a prospective study. Five hundred and forty-two consecutive patients referred for andrological examination were asked to complete a specific questionnaire at their first visit. For 449 patients who answered all questions, the individual score values could be calculated by scoring each answer with points. Patients with 'idiopathic' oligoasthenoteratozoospermia had significantly higher score values when compared with men showing normozoospermia (P < 0.01), 'symptomatic' oligoasthenoteratozoospermia as a result of defined andrological disorders (P < 0.01), cryptozoospermia (P < 0.01) or other pathological semen profiles (P < 0.05). These data support the hypothesis that patients with 'idiopathic' oligoasthenoteratozoospermia are more exposed to genital heat stress than normozoospermic men. Moreover, in patients with a varicocele impairment semen quality was associated with significantly higher score values compared with the subgroup of men with normal semen profiles (P < 0.05). In contrast, the score values did not significantly differ between equivalent subgroups of men with a history of a retractile testis. Our observations indicate that the questionnaire used in the present study allows an integrative assessment of genital heat stress, which is superior to single factor analysis. Notably, the group of men with 'idiopathic' oligoasthenoteratozoospermia showed the highest mean score values for 10 of the 18 questions compared with the other groups. Prolonged sitting in a vehicle represented the only single factor with significantly different score values in patients with 'idiopathic' oligoasthenoteratozoospermia and those with normozoospermia (P < 0.05).

  8. Efficacy evaluation of a commercial neem cake for control of Haematobia irritans on Nelore cattle.

    PubMed

    Chagas, Ana Carolina de Souza; Oliveira, Márcia Cristina de Sena; Giglioti, Rodrigo; Calura, Fernando Henrique; Ferrenzini, Jenifer; Forim, Moacir Rossi; Barros, Antonio Thadeu Medeiros de

    2010-01-01

    Much attention has been given to the development of botanical insecticides to provide effective natural control of cattle ectoparasites without harming animals, consumers, and environment. This study evaluated the efficacy of a commercial neem cake in controlling Haematobia irritans infestation on cattle. The study was conducted at the Embrapa Southeast Cattle Research Center (CPPSE), in São Carlos, SP, Brazil, from April to July 2008. The neem cake mixed in mineral salt in a 2% concentration was provided to 20 Nelore cows during nine weeks and had its efficacy evaluated by comparison of the infestation level against a control group. Fly infestations were recorded weekly by digital photographs of each animal from both groups and the number of flies was later counted in a computer-assisted image analyzer. Quantification of neem cake components by high-performance liquid chromatography revealed the presence of azadirachtin (421 mg.kg(-1)) and 3-tigloyl-azadirachtol (151 mg.kg(-1)) in the tested neem cake. Addition of the 2% neem cake reduced mineral salt intake in about 22%. The 2% neem cake treatment failed to reduce horn fly infestations on cattle during the 9-week study period.

  9. Evaluation of efficacy of four commercial enzyme-based cleaners of ultrafiltration systems.

    PubMed

    Smith, K E; Bradley, R L

    1987-06-01

    Use of UF and RO in the dairy industry is rapidly expanding. Because the dairy industry demands high levels of cleanliness, this new technology requires close evaluation to assure adherence to these standards. Efficacy of four commercial enzyme-based cleaners (pH 7.0 to 8.4) in UF systems was determined by microbiological evaluation and permeate flux restoration. The UF system containing two polysulfone UF membranes in parallel, was soiled by recycling 380 L of sweet whey (40 degrees C) for 2.0 h followed by concentrating whey for .5 h. The cleaning cycle consisted of acid cleaner (.5 h, 40 degrees C), followed by enzyme cleaner (10.0 h, 40 degrees C), and rinsing (2.0 h, 40 degrees C). A chlorine sanitizer was circulated (5 min, 40 degrees C) and the unit containing sanitizing solution left idle overnight. Flux was determined and swabs and rinse water samples were taken immediately after soiling, after cleaning, and the next morning to check sanitizing. The four enzyme-based cleaners were unsatisfactory when microbiological criteria were considered. Loss of sanitizer strength and problems with yeast and especially mold growth over time also indicated lack of effective cleaning. Flux, however, was restored easily and did not correlate with efficacy of cleaning based on numbers of microorganisms remaining.

  10. Safety and Efficacy Evaluation of Carnosine, An Endogenous Neuroprotective Agent for Ischemic Stroke

    PubMed Central

    Bae, Ok-Nam; Serfozo, Kelsey; Baek, Seung-Hoon; Lee, Ki Yong; Dorrance, Anne; Rumbeiha, Wilson; Fitzgerald, Scott D.; Farooq, Muhammad U; Naravelta, Bharath; Bhatt, Archit; Majid, Arshad

    2013-01-01

    Background and Purpose An urgent need exists to develop therapies for stroke which have high efficacy, long therapeutic time windows and acceptable toxicity. We undertook preclinical investigations of a novel therapeutic approach involving supplementation with carnosine, an endogenous pleiotropic dipeptide. Methods Efficacy and safety of carnosine treatment was evaluated in rat models of permanent or transient middle cerebral artery occlusion. Mechanistic studies used primary neuronal/astrocytic cultures and ex vivo brain homogenates. Results Intravenous treatment with carnosine exhibited robust cerebroprotection in a dose-dependent manner, with long clinically-relevant therapeutic time windows of 6 h and 9 h in transient and permanent models, respectively. Histological outcomes and functional improvements including motor and sensory deficits were sustained at 14 d post-stroke onset. In safety and tolerability assessments, carnosine did not exhibit any evidence of adverse effects or toxicity. Moreover, histological evaluation of organs, complete blood count, coagulation tests and the serum chemistry did not reveal any abnormalities. In primary neuronal cell cultures and ex vivo brain homogenates, carnosine exhibited robust anti-excitotoxic, antioxidant, and mitochondria protecting activity. Conclusion In both permanent and transient ischemic models, carnosine treatment exhibited significant cerebroprotection against histological and functional damage, with wide therapeutic and clinically relevant time windows. Carnosine was well tolerated and exhibited no toxicity. Mechanistic data show that it influences multiple deleterious processes. Taken together, our data suggest that this endogenous pleiotropic dipeptide is a strong candidate for further development as a stroke treatment. PMID:23250994

  11. [Serological characteristics and transfusion efficacy evaluation in 61 cases of autoimmune hemolytic anemia].

    PubMed

    Yu, Yang; Sun, Xiao-Lin; Ma, Chun-Ya; Guan, Xiao-Zhen; Zhang, Xiao-Juan; Chen, Lin-Fen; Wang, Ke; Luo, Yuan-Yuan; Wang, Yi; Li, Ming-Wei; Feng, Yan-Nan; Tong, Shan; Yu, Shuai; Yang, Lu; Wu, Yue-Qing; Zhuang, Yuan; Pan, Ji-Chun; Fen, Qian; Zhang, Ting; Wang, De-Qing

    2013-10-01

    This study was aimed to analyze the serological characteristics, efficacy and safety of incompatible RBC transfusion in patients with autoimmune hemolytic anemia (AIHA). The patients with idiopathic or secondary AIHA were analyzed retrospectively, then the serological characteristics and the incidence of adverse transfusion reactions were investigated, and the efficacy and safety of incompatible RBC transfusion were evaluated according to the different autoantibody type and infused different RBC components. The results showed that out of 61 cases of AIHA, 21 cases were idiopathic, and 40 cases were secondary. 8 cases (13.1%) had IgM cold autoantibody, 50 cases (82.0%) had IgG warm autoantibody, and 3 cases (4.9%) had IgM and IgG autoantibodies simultaneously. There were 18 cases (29.5%) combined with alloantibodies. After the exclusion of alloantibodies interference, 113 incompatible RBC transfusions were performed for 36 patients with AIHA, total efficiency rate, total partial efficiency rate and total inefficiency rate were 56.6%, 15.1% and 28.3%, respectively. Incompatible RBC transfusions were divided into non-washed RBC group and washed RBC group. The efficiency rate, partial efficiency rate and inefficiency rate in non-washed RBC group were 57.6%, 13.0% and 29.4%, respectively. The efficiency rate, partial efficiency rate and inefficiency rate in washed RBC group were 53.6%, 21.4% and 25.0%, respectively. There was no significant difference of transfusion efficacy (P > 0.05) in two groups. Incompatible RBC transfusions were also divided into IgM cold autoantibody group and IgG warm autoantibody group. The efficiency rate, partial efficiency rate and inefficiency rate in IgM cold autoantibody group were 46.2%, 30.8% and 29.4%, respectively. The efficiency rate, partial efficiency rate and inefficiency rate in IgG warm autoantibody group were 56.7%, 13.4% and 29.9%, respectively. There was no significant difference of transfusion efficacy (P > 0.05 ) in two

  12. A prospective cohort study to evaluate peridomestic infection as a determinant of dengue transmission: Protocol

    PubMed Central

    2012-01-01

    Background Vector control programs, which have focused mainly on the patient house and peridomestic areas around dengue cases, have not produced the expected impact on transmission. This project will evaluate the assumption that the endemic/epidemic transmission of dengue begins around peridomestic vicinities of the primary cases. Its objective is to assess the relationship between symptomatic dengue case exposure and peridomestic infection incidence. Methods/Design A prospective cohort study will be conducted (in Tepalcingo and Axochiapan, in the state of Morelos, Mexico), using the state surveillance system for the detection of incident cases. Paired blood specimens will be collected from both the individuals who live with the incident cases and a sample of subjects residing within a 25-meter radius of such cases (exposed cohort), in order to measure dengue-specific antibodies. Other subjects will be selected from areas which have not presented any incident cases within 200 meters, during the two months preceding the sampling (non-exposed cohort). Symptomatic/asymptomatic incident infection will be considered as the dependent variable, exposure to confirmed dengue cases, as the principal variable, and the socio-demographic, environmental and socio-cultural conditions of the subjects, as additional explanatory variables. Discussion Results indicating a high infection rate among the exposed subjects would justify the application of peridomestic control measures and call for an evaluation of alternate causes for insufficient program impact. On the other hand, a low incidence of peridomestic-infected subjects would support the hypothesis that infection occurs outside the domicile, and would thus explain why the vector control measures applied in the past have exerted such a limited impact on cases incidence rates. The results of the present study may therefore serve to reassess site selection for interventions of this type. PMID:22471857

  13. Monte Carlo fluence simulation for prospective evaluation of interstitial photodynamic therapy treatment plans

    NASA Astrophysics Data System (ADS)

    Cassidy, Jeffrey; Betz, Vaughn; Lilge, Lothar

    2015-03-01

    Photodynamic therapy (PDT) delivers a localized cytotoxic dose that is a function of tissue oxygen availability, photosensitive drug concentration, and light fluence. Providing safe and effective PDT requires an understanding of all three elements and the physiological response to the radicals generated. Interstitial PDT (IPDT) for solid tumours poses particular challenges due to complex organ geometries and the associated limitations for diffusion theory based fluence rate prediction, in addition to restricted access for light delivery and dose monitoring. As a first step towards enabling a complete prospective IPDT treatment-planning platform, we demonstrate use of our previously developed FullMonte tetrahedral Monte Carlo simulation engine for modeling of the interstitial fluence field due to intravesicular insertion of brief light sources. The goal is to enable a complete treatment planning and monitoring work flow analogous to that used in ionizing radiation therapy, including plan evaluation through dose-volume histograms and algorithmic treatment plan optimization. FullMonte is to our knowledge the fastest open-source tetrahedral MC light propagation software. Using custom hardware acceleration, we achieve 4x faster computing with 67x better power efficiency for limited-size meshes compared to the software. Ongoing work will improve the performance advantage to 16x with unlimited mesh size, enabling algorithmic plan optimization in reasonable time. Using FullMonte, we demonstrate significant new plan-evaluation capabilities including fluence field visualization, generation of organ dose-volume histograms, and rendering of isofluence surfaces for a representative bladder cancer mesh from a real patient. We also discuss the advantages of MC simulations for dose-volume histogram generation and the need for online personalized fluence-rate monitoring.

  14. Prospective evaluation of shape similarity based pose prediction method in D3R Grand Challenge 2015

    NASA Astrophysics Data System (ADS)

    Kumar, Ashutosh; Zhang, Kam Y. J.

    2016-09-01

    Evaluation of ligand three-dimensional (3D) shape similarity is one of the commonly used approaches to identify ligands similar to one or more known active compounds from a library of small molecules. Apart from using ligand shape similarity as a virtual screening tool, its role in pose prediction and pose scoring has also been reported. We have recently developed a method that utilizes ligand 3D shape similarity with known crystallographic ligands to predict binding poses of query ligands. Here, we report the prospective evaluation of our pose prediction method through the participation in drug design data resource (D3R) Grand Challenge 2015. Our pose prediction method was used to predict binding poses of heat shock protein 90 (HSP90) and mitogen activated protein kinase kinase kinase kinase (MAP4K4) ligands and it was able to predict the pose within 2 Å root mean square deviation (RMSD) either as the top pose or among the best of five poses in a majority of cases. Specifically for HSP90 protein, a median RMSD of 0.73 and 0.68 Å was obtained for the top and the best of five predictions respectively. For MAP4K4 target, although the median RMSD for our top prediction was only 2.87 Å but the median RMSD of 1.67 Å for the best of five predictions was well within the limit for successful prediction. Furthermore, the performance of our pose prediction method for HSP90 and MAP4K4 ligands was always among the top five groups. Particularly, for MAP4K4 protein our pose prediction method was ranked number one both in terms of mean and median RMSD when the best of five predictions were considered. Overall, our D3R Grand Challenge 2015 results demonstrated that ligand 3D shape similarity with the crystal ligand is sufficient to predict binding poses of new ligands with acceptable accuracy.

  15. A prospective 9-month human clinical evaluation of Laser-Assisted New Attachment Procedure (LANAP) therapy.

    PubMed

    Nevins, Marc; Kim, Soo-Woo; Camelo, Marcelo; Martin, Ignacio Sanz; Kim, David; Nevins, Myron

    2014-01-01

    This investigation was designed and implemented as a single-center, prospective study to evaluate the clinical response to the Laser-Assisted New Attachment Procedure (LANAP). Eight patients with advanced periodontitis were enrolled and treated with full-mouth LANAP therapy and monitored for 9 months. Fullmouth clinical measurements, including clinical attachment level (CAL), probing depth (PD), and recession, were provided at baseline and after 9 months of healing by a single calibrated examiner, including a total of 930 sites and 444 sites with initial PD equal to or greater than 5 mm. Clinical results for the 930 sites measured pre- and postoperatively revealed that mean PD was reduced from 4.62 ± 2.29 mm to 3.14 ± 1.48 mm after 9 months (P < .05). CAL decreased from 5.58 ± 2.76 mm to 4.66 ± 2.10 mm (P < .05) and recession increased from 0.86 ± 1.31 mm to 1.52 ± 1.62 after 9 months (P < .05). For the subset of 444 sites with initial PD greater than or equal to 5 mm, the PD decreased from 6.50 ± 2.07 mm to 3.92 ± 1.54 mm (P < .05) and CAL decreased from 7.42 ± 2.70 mm to 5.78 ± 2.06 mm (P < .05). As demonstrated by the clinical evaluation, the majority of treated sites demonstrated clinical improvement. LANAP therapy should be further investigated with long-term clinical trials to compare the stability of clinical results with conventional therapy.

  16. Prospective biomechanical evaluation of donor site morbidity after radial forearm free flap.

    PubMed

    Riecke, Björn; Kohlmeier, Carsten; Assaf, Alexandre T; Wikner, Johannes; Drabik, Anna; Catalá-Lehnen, Philip; Heiland, Max; Rendenbach, Carsten

    2016-02-01

    Although the radial forearm free flap (RFF) is a commonly-used microvascular flap for orofacial reconstruction, we are aware of few prospective biomechanical studies of the donor site. We have therefore evaluated the donor site morbidity biomechanically of 30 consecutive RFF for orofacial reconstruction preoperatively and three months postoperatively. This included the Mayo wrist score, the Disabilities of the Arm, Shoulder and Hand (DASH) score, grip strength, followed by tip pinch, key pinch, palmar pinch, and range of movement of the wrist. Primary defects were all closed with local full-thickness skin grafts from the donor site forearm, thereby circumventing the need for a second defect. Postoperative functional results showed that there was a reduction in hand strength measured by (grip strength: -24.1%, in tip pinch: -23.3%, in key pinch: -16.5, and in palmar pinch: -19.3%); and wrist movement measured by extension (active=14.3% / passive= -11.5%) and flexion = -14.8% / -8.9%), and radial (-9.8% / -9.8%) and ulnar (-11.0% / -9.3%) abduction. The Mayo wrist score was reduced by 9.4 points (-12.9%) and the DASH score increased by 16.1 points (+35.5%) compared with the same forearm preoperatively. The local skin graft resulted in a robust wound cover with a good functional result. Our results show that the reduction in hand strength and wrist movement after harvest of a RFF is objectively evaluable, and did not reflect the subjectively noticed extent and restrictions in activities of daily living. Use of a local skin graft avoids a second donor site and the disadvantages of a split-thickness skin graft.

  17. Prospective evaluation of oral gastrografin(®) in the management of postoperative adhesive small bowel obstruction.

    PubMed

    Rahmani, Nasrin; Mohammadpour, Reza Ali; Khoshnood, Peyman; Ahmadi, Amirhossein; Assadpour, Sara

    2013-06-01

    Oral Gastrografin®, a hyperosmolar water-soluble contrast medium, may have a therapeutic effect in adhesive small bowel obstruction. However, findings are still conflicting, as some authors did not find a therapeutic advantage. So, this prospective, randomized, and clinical trial study was designed to determine the value of Gastrografin in adhesive small bowel obstruction. The primary end points were the evaluation of the operative rate reduction and shortening the hospital stay after the use of Gastrografin. A total of 84 patients were randomized into two groups: the control group received conventional treatment, whereas the study group received in addition of 100 mL Gastrografin meal. Patients were followed up within 4 days after admission, and clinical and radiological (if needed) improvements were evaluated. Although the results showed that Gastrografin can decrease the need for surgical management by 14.5 %, no statistically significant differences were observed between the two groups (P = 0.07). Nevertheless, the length of hospital stay revealed a significant reduction from 4.67 ± 1.18 days to 2.69 ± 1.02 days (P = 0.00). The use of Gastrografin in adhesive small bowel obstruction is safe and reduces the length of hospital stay. As a result, the cost of hospital bed occupancy is reduced. Hence, if there was no indication of emergency surgery, administration of oral Gastrografin as a nonoperative treatment in adhesive small bowel obstruction is also recommended.

  18. Prospective evaluation of a new device for the treatment of anal fistulas

    PubMed Central

    Ratto, Carlo; Litta, Francesco; Donisi, Lorenza; Parello, Angelo

    2016-01-01

    AIM: To evaluate the safety of the implantation of a new device for the treatment of anal fistulas. The short-term clinical efficacy was also assessed. METHODS: This study took place at a tertiary care university hospital. Patients with a complex anal fistula of cryptoglandular origin were enrolled in the study and were treated with insertion of the new device. All patients were evaluated by clinical and physical examination, including an endoanal ultrasound at the baseline, and then at the 2 wk and 1, 2, 3 and 6-mo follow-up visits. RESULTS: Morbidity, continence status, and success rate were the main outcome measures. Ten patients underwent the placement of the new device. The fistulas were transphincteric in eight patients and extrasphincteric in the remaining two. The median duration of the surgical procedure was 34.5 (range, 27-42) min. Neither intra- nor postoperative complications occurred, and all patients were discharged the day after the procedure. At the 6-mo follow-up evaluation, the final success rate was 70%. Three failures were registered: a device expulsion (on the 10th postoperative day), the persistence of inflammatory tissue around the fistula tract (at the 2-mo follow up), and the persistence of serum discharge (at the 6-mo follow up). No patient experienced any change incontinence, as assessed by the Cleveland Clinic Fecal Incontinence score. CONCLUSION: The technical procedure is simple and has low risk of perioperative morbidity. The pre- and post-operative continence status did not change in any of the patients. The initial results at the 6-mo follow up seem to be promising. However, a longer follow-up period and a larger sample size are needed to confirm these preliminary results. PMID:27570429

  19. Safety and efficacy of a growth factor and cytokine-containing topical product in wound healing and incision scar management after upper eyelid blepharoplasty: a prospective split-face study

    PubMed Central

    Murdock, Jennifer; Sayed, Mohamed S; Tavakoli, Mehdi; Portaliou, Dimitra M; Lee, Wendy W

    2016-01-01

    Purpose To evaluate the efficacy and safety of a topical product containing a mixture of growth factors and cytokines on the incision scar following upper eyelid blepharoplasty. Methods This is a prospective, single-blinded, and split-face study on patients who underwent bilateral upper eyelid blepharoplasty. Two weeks after surgery, one eye of each subject was randomized to receive Lumière Bio-Restorative Eye Cream on one eyelid incision for 12 weeks and no treatment on the other eyelid. Subjects returned at the postoperative weeks 6, 10, and 14. At each visit, patients and the investigator (who was blinded to the treated eyelid) evaluated the scar through specified questionnaires. Results A total of 20 subjects with a mean age of 66.3±9.2 years completed the study. Minor side effects were noted in three subjects. At all-time points, all subjects thought eyelids treated with Lumière had a better scar and overall appearance than fellow eyelids (P<0.5); and 60% of patients strongly encouraged others to use the product. The investigator assessment of erythema and pigmentation revealed less erythema and pigmentation in treated eyes at the weeks 6 and 10, although the difference was statistically insignificant. Investigator assessment also revealed a better scar appearance at week 10 in treated eyes (P=0.04). All evaluation parameters were similar in both eyes at the last visit. Conclusion Lumière eye cream shows an excellent safety profile and minimal effects on features of the incision scar following upper lid blepharoplasty. It may hasten the wound healing process considering the higher outcomes at the first weeks of application. PMID:27418806

  20. The Evaluation of a Sexual Assault Self-Defense and Risk-Reduction Program for College Women: A Prospective Study

    ERIC Educational Resources Information Center

    Gidycz, Christine A.; Rich, Cindy L.; Orchowski, Lindsay; King, Carrie; Miller, Audrey K.

    2006-01-01

    The present study evaluated the efficacy of a sexual assault risk-reduction program that included a physical self-defense component for college women ("N"=500). Program group women significantly increased their protective behaviors over the 6-month follow-up period compared to the waiting-list control group. However, there were no significant…

  1. Evaluation of clinical safety and anthelmintic efficacy of aurixazole administed orally at 24 mg/kg in cattle.

    PubMed

    Sakamoto, Claudio Alessandro M; Lopes, Welber Daniel Zanetti; Buzzulini, Carolina; Cruz, Breno Cayeiro; Felippelli, Gustavo; Teixeira, Weslen F; Silva, Helenara Machado; Santana, Luis Fernando; Soares, Vando Edésio; Henrique, Carlos Henrique; de Oliveira, Gilson Pereira; da Costa, Alvimar José

    2014-06-01

    The current study evaluated, in vivo, the clinical safety and the anthelmintic efficacy of 24% aurixazole (24 mg/kg), administered orally, in bovines. Two experiments were conducted: the first one evaluating the clinical safety of 24% aurixazole (24 mg/kg) in cattle, and a second one evaluating the anthelmintic efficacy of aurixazole (24 mg/kg) against gastrointestinal nematodes on naturally infected cattle. Based on the results of clinical safety, no alterations on clinical and haematological signs and on the biochemical values obtained in animals treated orally with aurixazole 24 mg/kg were observed. Regarding the results of reduction or efficacy, obtained by eggs per gram of faeces (EPG) counts, the formulation of aurixazole reached values superior to 99% (arithmetic means) in all post-treatment dates. In two occasions, this formulation reached maximum efficacy (100%). Comparing these results with the reduction percentages obtained by EPG counts, it is possible to verify that the values obtained by all three formulations were compatible with the efficacy results. Aurixazole reached maximum efficacy (100%) against Haemonchus placei, Cooperia spatulata and Oesophagostomum radiatum. Against Cooperia punctata, this formulation reached an efficacy index of 99.99%. Regarding aurixazole, no specific trials were conducted on the field in order to evaluate the behaviour of this molecule against helminths that are resistant to other molecules, specially isolated levamisole and disophenolat. Due to this fact, future studies will be necessary to assess the effectiveness of aurixazole against strains of nematodes that are resistant to levamisole and disophenolat, but the results of clinical safety and efficacy described in this study allow us to conclude that the aurixazole molecule, concomitantly with other measures and orally administered formulations, can be another important tool in the control of nematodes parasitizing bovines.

  2. Field experiments to evaluate host plant specificity of prospective agents of Onopordum acanthium in Bulgaria

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Scotch thistle, Onopordum acanthium, is an invasive alien weed in North America that originates from Europe. Previous field observations in Bulgaria have confirmed the presence of prospective biological control agents including Cassida rubiginosa, Chaetostomella cylindrica, Eublemma amoena, Larinus ...

  3. First Results Of The Diagnostic Evaluation Studies And The Clinical Efficacy Evaluation In The Dutch PACS Project

    NASA Astrophysics Data System (ADS)

    Barneveld Binkhuysen, F. H.; Ottes, F. P.; ter Haar Romeny, B. M.; Klessens, P. L. M.; Vos, C. G.; Winter, L. H. L.; Calkoen, P. T.; Andriessen, J. H. T. H.

    1989-05-01

    The objective of the studies was to evaluate the diagnostic performance of the image digitizing distribution and display equipment of the installed PACS (Philips) in the Utrecht University Hospital (see also procee-dings SPIE 914, 1988). The diagnostic accuracy was evaluated by means of observer performance studies, using ROC analysis. Three series of films were used: chest phantom radiographs, clinical mammographic films, and clinical head CT's. We compared: original films versus images digitized with a video scanner, and/or original films versus images digitized with a laser scanner. Both scanners have 1024x1024x8 bits output resolution. Four radiologists scored the presence on a 5-point scale. The results of the mammographic and head CT series will be presented in this paper. The results of the diagnostic accuracy studies of the chest radiographs and their specific methodology will be presented in a companion SPIE paper. Goal of the clinical efficacy study is to see if the use of a PACS multimodality viewing station at an internal ward has clinical advantages as compared to the conventional situation. Using PACS integrated with a HIS (including a RIS) more easier and faster information is accessible to the clinicians. In this paper we will describe: the procedures which are needed to evaluate the use of the workstation installed at the internal ward, the development of the user interface with four layers of the Image Management System, and the methodology of evaluation the clinical advantages.

  4. Investigating Second Language Learner Self-Efficacy and Future Expectancy of Second Language Use for High-Stakes Program Evaluation

    ERIC Educational Resources Information Center

    Gorsuch, Greta

    2009-01-01

    As part of a larger summative evaluation of a foreign language department and a two-year foreign language core competency, the researcher investigated fourth-semester student self-efficacy (a person's belief, rooted in experience, that they can do something) and future expectancy of second language use. In effect, this was also an evaluation of…

  5. The Evaluation Self-Efficacy Scale for Assessing Progress toward CSWE Accreditation-Related Objectives: A Replication

    ERIC Educational Resources Information Center

    Holden, Gary; Barker, Kathleen; Rosenberg, Gary; Onghena, Patrick

    2008-01-01

    Objective: The Evaluation Self-Efficacy Scale (ESE) is being developed as an outcomes assessment instrument for social work courses focusing on evaluation. Method: This scale, based on social cognitive theory, was pretested, revised, and then used with a final sample of 85 master's-level students in the original study. Using a single-group,…

  6. Application of gemstone spectral imaging for efficacy evaluation in hepatocellular carcinoma after transarterial chemoembolization

    PubMed Central

    Liu, Qi-Yu; He, Chuan-Dong; Zhou, Ying; Huang, Dan; Lin, Hua; Wang, Zhong; Wang, Dong; Wang, Jin-Qiu; Liao, Li-Ping

    2016-01-01

    AIM: To assess the value of gemstone spectral imaging (GSI) in efficacy evaluation in hepatocellular cancer (HCC) after transcatheter arterial chemoembolization (TACE) treatment. METHODS: Thirty patients with HCC underwent GSI, including nonenhanced, arterial, portalvenous and delayed phase scans, after TACE treatment. Arterial phase images were acquired with GSI for reconstruction of virtual nonenhanced images and color overlay images. Digital subtraction angiography (DSA) was performed in all these patients. Two blinded and independent readers evaluated the data in two reading sessions; standard nonenhanced, arterial, portalvenous, and delayed phase images were read in session A, and the optimal monochromatic images, iodine/water based images and spectrum features were read in session B. Sensitivity and specificity were calculated with the DSA data as the reference standard. The sensitivity and specificity were compared using the χ2 test. RESULTS: DSA revealed 154 lesions in 30 patients, and 100 of them had blood supply. Overall sensitivity and specificity were 72% (72/100) and 77.8% (42/54) for session A, and 97% (97/100) and 94.4% (51/54) for session B, respectively. The sensitivity and specificity of the two reading sessions were significantly different (χ2 = 23.04, χ2 = 7.11, P < 0.05). CONCLUSION: Compared with conventional CT, GSI could significantly improve the detection of small and multiple lesions without increasing the radiation dose. Based on spectrum features, GSI could assess tumor homogeneity and more accurately identify residual tumors and recurrent or metastatic lesions during efficacy evaluation and follow-up in HCC after TACE treatment. PMID:27004002

  7. Duration of temporary catheter use for hemodialysis: an observational, prospective evaluation of renal units in Brazil

    PubMed Central

    2011-01-01

    Background For chronic hemodialysis, the ideal permanent vascular access is the arteriovenous fistula (AVF). Temporary catheters should be reserved for acute dialysis needs. The AVF is associated with lower infection rates, better clinical results, and a higher quality of life and survival when compared to temporary catheters. In Brazil, the proportion of patients with temporary catheters for more than 3 months from the beginning of therapy is used as an evaluation of the quality of renal units. The aim of this study is to evaluate factors associated with the time between the beginning of hemodialysis with temporary catheters and the placement of the first arteriovenous fistula in Brazil. Methods This is an observational, prospective non-concurrent study using national administrative registries of all patients financed by the public health system who began renal replacement therapy (RRT) between 2000 and 2004 in Brazil. Incident patients were eligible who had hemodialysis for the first time. Patients were excluded who: had hemodialysis reportedly started after the date of death (inconsistent database); were younger than 18 years old; had HIV; had no record of the first dialysis unit; and were dialyzed in units with less than twenty patients. To evaluate individual and renal unit factors associated with the event of interest, the frailty model was used (N = 55,589). Results Among the 23,824 patients (42.9%) who underwent fistula placement in the period of the study, 18.2% maintained the temporary catheter for more than three months until the fistula creation. The analysis identified five statistically significant factors associated with longer time until first fistula: higher age (Hazard-risk - HR 0.99, 95% CI 0.99-1.00); having hypertension and cardiovascular diseases (HR 0.94, 95% CI 0.9-0.98) as the cause of chronic renal disease; residing in capitals cities (HR 0.92, 95% CI 0.9-0.95) and certain regions in Brazil - South (HR 0.83, 95% CI 0.8-0.87), Midwest (HR 0

  8. Travoprost 0.004%/timolol 0.5%-fixed combination with and without benzalkonium chloride: a prospective, randomized, doubled-masked comparison of safety and efficacy

    PubMed Central

    Kitazawa, Y; Smith, P; Sasaki, N; Kotake, S; Bae, K; Iwamoto, Y

    2011-01-01

    Purpose The purpose of this study is to compare the safety and intraocular pressure (IOP)-lowering efficacy of travoprost/timolol in a benzalkonium chloride (BAK)-free fixed combination preserved with polyquaternium-1 (TRA/TIM BAK-free), with travoprost/timolol-fixed combination preserved with BAK (TRA/TIM), in patients with open-angle glaucoma or ocular hypertension. Methods In this prospective randomized controlled trial, subjects with IOP of at least 22 mm Hg in one or both eyes at 0900 h, and IOP of at least 21 mm Hg in one or both eyes at 1100 h and 1600 h at two eligibility visits were randomly assigned to receive either TRA/TIM BAK-free (n=195) or TRA/TIM (n=193), dosed once daily in the morning (0900 h) for 6 weeks. IOP was assessed at 0900 h, 1100 h, and 1600 h at each scheduled visit (baseline, 2 and 6 weeks after randomization). Results Mean IOP reduction across all visits and time points was 8.0 mm Hg in the TRA/TIM BAK-free group and 8.4 mm Hg in the TRA/TIM group (P=0.0943). The difference in mean IOP between groups ranged from 0.2 to 0.7 mm Hg across visits and time points, with a mean pooled difference of 0.4 mm Hg (95% CI: −0.1 to 0.8), demonstrating equivalence of the two formulations. The most common drug-related adverse event was hyperemia of the eye (ocular hyperemia and conjunctival hyperemia combined), occurring in 11.8% of the TRA/TIM BAK-free group and 13.0% of the TRA/TIM group. Conclusion Travoprost/timolol BAK-free demonstrated equivalence to travoprost/timolol preserved with BAK in efficacy. No clinically relevant differences in the safety profiles of travoprost/timolol BAK-free and travoprost/timolol preserved with BAK were identified. PMID:21701528

  9. Prospective evaluation of quality of life after interstitial brachytherapy for localized prostate cancer

    SciTech Connect

    Caffo, Orazio . E-mail: orazio.caffo@apss.tn.it; Fellin, Gianni; Bolner, Andrea; Coccarelli, Franco; Divan, Claudio; Frisinghelli, Michela; Mussari, Salvatore; Ziglio, Franco; Malossini, Gianni; Tomio, Luigi; Galligioni, Enzo

    2006-09-01

    Purpose: Permanent interstitial brachytherapy (IB) has become an increasingly appealing therapeutic option for localized prostate cancer (LPC) among physicians and patients because it involves short hospitalization and treatment and its postulated low degree of toxicity may reduce its impact on the patients' quality of life (QoL). The aim of this prospective study was to assess the impact of IB on the QoL of patients with LPC. Methods and Materials: A validated self-completed questionnaire was administered to the patients before and after IB and then at yearly intervals. The items allowed the identification of seven subscales exploring physical well-being (PHY), physical autonomy (POW), psychological well-being (PSY), relational life (REL), urinary function (URI), rectal function (REC), and sexual function (SEX). Results: The assessment of the QoL of 147 patients treated between May 2000 and February 2005 revealed no relevant differences in the PHY scale scores 1 month after IB or later, and the same was true of the POW, PSY, and REL scales. Urinary function significantly worsened after IB and returned to pretreatment levels only after 3 years; the impact of the treatment on the URI scale was greater in the patients with good baseline urinary function than in those presenting more urinary symptoms before IB. Rectal and sexual functions were significantly worse only at the post-IB evaluation. Conclusions: The results of the present study confirm that the impact of IB on the patients' QoL is low despite its transient negative effects on some function, and extend existing knowledge concerning QoL after IB.

  10. An evaluation of prospective motion correction (PMC) for high resolution quantitative MRI

    PubMed Central

    Callaghan, Martina F.; Josephs, Oliver; Herbst, Michael; Zaitsev, Maxim; Todd, Nick; Weiskopf, Nikolaus

    2015-01-01

    Quantitative imaging aims to provide in vivo neuroimaging biomarkers with high research and diagnostic value that are sensitive to underlying tissue microstructure. In order to use these data to examine intra-cortical differences or to define boundaries between different myelo-architectural areas, high resolution data are required. The quality of such measurements is degraded in the presence of motion hindering insight into brain microstructure. Correction schemes are therefore vital for high resolution, whole brain coverage approaches that have long acquisition times and greater sensitivity to motion. Here we evaluate the use of prospective motion correction (PMC) via an optical tracking system to counter intra-scan motion in a high resolution (800 μm isotropic) multi-parameter mapping (MPM) protocol. Data were acquired on six volunteers using a 2 × 2 factorial design permuting the following conditions: PMC on/off and motion/no motion. In the presence of head motion, PMC-based motion correction considerably improved the quality of the maps as reflected by fewer visible artifacts and improved consistency. The precision of the maps, parameterized through the coefficient of variation in cortical sub-regions, showed improvements of 11–25% in the presence of deliberate head motion. Importantly, in the absence of motion the PMC system did not introduce extraneous artifacts into the quantitative maps. The PMC system based on optical tracking offers a robust approach to minimizing motion artifacts in quantitative anatomical imaging without extending scan times. Such a robust motion correction scheme is crucial in order to achieve the ultra-high resolution required of quantitative imaging for cutting edge in vivo histology applications. PMID:25859178

  11. Clinical and radiographic evaluation of single tantalum dental implants: a prospective pilot clinical study

    PubMed Central

    DE FRANCESCO, M.; GOBBATO, E.A.; NOCE, D.; CAVALLARI, F.; FIORETTI, A.

    2016-01-01

    SUMMARY Objective The aim of this prospective pilot clinical case series report was to evaluate, through a clinical and radiographic analysis, the peri-implant bone resorption of the tantalum dental implants (TMT) (Zimmer TMT, Parsippany, NJ, USA) one year after prosthetic rehabilitation. Methods Twenty tantalum dental implants were placed in both maxillas and mandibles of 20 patients. Patients were asked to attend a radiographic and clinical follow-up and their previous clinical records and X-rays were assessed. Bone levels were calculated by digitally measuring the distance from the implant shoulder to the first bone-to-implant on periapical radiographs taken at surgery and after 6 and 12 months of functioning. The Pearson correlation analysis was performed to assess it there was a correlation between the measurement of the marginal bone loss (MBL). The Anova Test with a post-hoc analysis using Bonferroni’s test was used to compare the three group (0, 6 months and 12 months). Results The mean total MBL for the group 0 months was 0.84 mm (SD 0.21), 6 months was 0.87 mm (SD 0.22) and for 12 months was 0.89 mm (SD 0.23). The values of the Pearson’s coefficients showed that the data measurement were positively correlated. The Anova test showed a statistically significant difference between the groups. Conclusion The statistically significant difference in marginal bone loss can be considered physiological. Within the limits of this study it can be concluded that TMT implants have an excellent bone crest’s stability, however, to have most accurate information, will be necessary extend the sample. PMID:28280531

  12. Prospective evaluation of rapid antigen tests for diagnosis of respiratory syncytial virus and human metapneumovirus infections.

    PubMed

    Aslanzadeh, Jaber; Zheng, Xiaotian; Li, Haijing; Tetreault, Janice; Ratkiewicz, Irene; Meng, Shufang; Hamilton, Pamela; Tang, Yi-Wei

    2008-05-01

    Respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) are two important viral pathogens that cause respiratory tract infections in the pediatric population. The rapid detection of these agents allows the prompt isolation and treatment of infected patients. In the present prospective study, we evaluated the performances of four rapid antigen detection assays, including a rapid chromatographic immunoassay (CIA) for RSV (Directigen EZ RSV; Becton Dickinson, Sparks, MD), a direct fluorescent-antibody assay (DFA) for RSV (Bartels; Trinity Biotech, Carlsbad, CA), and two DFAs for hMPV manufactured by Diagnostic Hybrids Inc. (DHI; Athens, OH) and Imagen (Oxoid Ltd., Basingstoke, Hampshire, United Kingdom). The clinical specimens tested comprised 515 nasopharyngeal aspirates submitted to the Clinical Microbiology Laboratory at Hartford Hospital from 1 November 2006 to 21 April 2007. Compared to the results of real-time reverse transcription-PCR (RT-PCR), the CIA had a sensitivity of 79.8% and a specificity of 89.5%. The RSV DFA with Bartels reagents showed a sensitivity of 94.1% and a specificity of 96.8%. For hMPV, the sensitivity and specificity were 62.5% and 99.8%, respectively, for the DHI DFA and 63.2% and 100%, respectively, for the Imagen DFA. The hands-on and test turnaround times for CIA were 10 and 30 to 60 min, respectively, and the hands-on and test turnaround times for the RSV and hMPV DFAs were 30 and 105 min, respectively. We conclude that while the RSV CIA is user-friendly, it lacks sensitivity and specificity, especially during off-peak months. In contrast, the RSV DFA is more sensitive and specific, but interpretation of its results is subjective and it demands technical time and expertise. Similarly, both hMPV DFAs are highly specific in comparison to the results of RT-PCR, but their sensitivities await further improvements.

  13. Prospective Evaluation of Rapid Antigen Tests for Diagnosis of Respiratory Syncytial Virus and Human Metapneumovirus Infections▿

    PubMed Central

    Aslanzadeh, Jaber; Zheng, Xiaotian; Li, Haijing; Tetreault, Janice; Ratkiewicz, Irene; Meng, Shufang; Hamilton, Pamela; Tang, Yi-Wei

    2008-01-01

    Respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) are two important viral pathogens that cause respiratory tract infections in the pediatric population. The rapid detection of these agents allows the prompt isolation and treatment of infected patients. In the present prospective study, we evaluated the performances of four rapid antigen detection assays, including a rapid chromatographic immunoassay (CIA) for RSV (Directigen EZ RSV; Becton Dickinson, Sparks, MD), a direct fluorescent-antibody assay (DFA) for RSV (Bartels; Trinity Biotech, Carlsbad, CA), and two DFAs for hMPV manufactured by Diagnostic Hybrids Inc. (DHI; Athens, OH) and Imagen (Oxoid Ltd., Basingstoke, Hampshire, United Kingdom). The clinical specimens tested comprised 515 nasopharyngeal aspirates submitted to the Clinical Microbiology Laboratory at Hartford Hospital from 1 November 2006 to 21 April 2007. Compared to the results of real-time reverse transcription-PCR (RT-PCR), the CIA had a sensitivity of 79.8% and a specificity of 89.5%. The RSV DFA with Bartels reagents showed a sensitivity of 94.1% and a specificity of 96.8%. For hMPV, the sensitivity and specificity were 62.5% and 99.8%, respectively, for the DHI DFA and 63.2% and 100%, respectively, for the Imagen DFA. The hands-on and test turnaround times for CIA were 10 and 30 to 60 min, respectively, and the hands-on and test turnaround times for the RSV and hMPV DFAs were 30 and 105 min, respectively. We conclude that while the RSV CIA is user-friendly, it lacks sensitivity and specificity, especially during off-peak months. In contrast, the RSV DFA is more sensitive and specific, but interpretation of its results is subjective and it demands technical time and expertise. Similarly, both hMPV DFAs are highly specific in comparison to the results of RT-PCR, but their sensitivities await further improvements. PMID:18337386

  14. Prospective evaluation of mitotane toxicity in adrenocortical cancer patients treated adjuvantly.

    PubMed

    Daffara, Fulvia; De Francia, Silvia; Reimondo, Giuseppe; Zaggia, Barbara; Aroasio, Emiliano; Porpiglia, Francesco; Volante, Marco; Termine, Angela; Di Carlo, Francesco; Dogliotti, Luigi; Angeli, Alberto; Berruti, Alfredo; Terzolo, Massimo

    2008-12-01

    Toxicity of adjuvant mitotane treatment is poorly known; thus, our aim was to assess prospectively the unwanted effects of adjuvant mitotane treatment and correlate the findings with mitotane concentrations. Seventeen consecutive patients who were treated with mitotane after radical resection of adrenocortical cancer (ACC) from 1999 to 2005 underwent physical examination, routine laboratory evaluation, monitoring of mitotane concentrations, and a hormonal work-up at baseline and every 3 months till ACC relapse or study end (December 2007). Mitotane toxicity was graded using NCI CTCAE criteria. All biochemical measurements were performed at our center and plasma mitotane was measured by an in-house HPLC assay. All the patients reached mitotane concentrations >14 mg/l and none of them discontinued definitively mitotane for toxicity; 14 patients maintained consistently elevated mitotane concentrations despite tapering of the drug. Side effects occurred in all patients but were manageable with palliative treatment and adjustment of hormone replacement therapy. Mitotane affected adrenal steroidogenesis with a more remarkable inhibition of cortisol and DHEAS than aldosterone. Mitotane induced either perturbation of thyroid function mimicking central hypothyroidism or, in male patients, inhibition of testosterone secretion. The discrepancy between salivary and serum cortisol, as well as between total and free testosterone, is due to the mitotane-induced increase in hormone-binding proteins which complicates interpretation of hormone measurements. A low-dose monitored regimen of mitotane is tolerable and able to maintain elevated drug concentrations in the long term. Mitotane exerts a complex effect on the endocrine system that may require multiple hormone replacement therapy.

  15. Prospective evaluation of Protein C and Factor VIII in prediction of cancer-associated thrombosis

    PubMed Central

    Tafur, AJ; Dale, G; Cherry, M; Wren, JD; Mansfield, AS; Comp, P; Rathbun, S; Stoner, JA

    2015-01-01

    Venous thromboembolism (VTE) is a preventable disease, yet it is one of the leading causes of death among patients with cancer. Improving risk stratification mechanisms will allow us to personalize thromboprophylaxis strategies. We sought to evaluate Collagen and Thrombin Activated Platelets (COAT-platelets) as well as protein C and factor VIII as biomarkers predictive of cancer-associated thrombosis in a prospective cohort of patients with cancer. Protein C was selected as a candidate based on bioinformatics prediction. Blood samples were collected before chemotherapy. All specimen processing was blinded to clinical data. Surveillance and adjudication of the main outcome of VTE was performed for up to 1 year. We used Cox proportional hazard regression to measure the association of biomarkers and incident events using SAS 9.2 for all statistical analysis. Death was modeled as a competing event. Among 241 patients followed for an average of 10.4 months, 15% died and 13% developed a VTE. COAT-platelets were not predictive of VTE. Low levels of pre-chemotherapy protein C (< 118 %) (HR 2.5; 95%CI 1.1–5.5) and high baseline factor VIII (> 261 % I) (HR 3.0; 95%CI 1.1–8.0) were predictive of VTE after adjusting for age, Khorana prediction risk, metastatic disease and D dimer. In addition, low protein C was predictive of overall mortality independent of age, metastatic disease and functional status (HR 2.8; 95%CI 1.3–6.0). Addition of these biomarkers to Cancer-VTE risk prediction models may add to risk stratification and patient selection to optimize thrombo-prophylaxis. PMID:26475410

  16. Results of a prospective multicenter trial evaluating the ePTFE peritoneal onlay laparoscopic inguinal hernioplasty.

    PubMed

    Toy, F K; Moskowitz, M; Smoot, R T; Pleatman, M; Bagdasarian, A; Polito, W; Carey, S D; Schatz, R; Janes, K; Zipser, M E

    1996-12-01

    A 2.8-year prospective multicenter trial was conducted to evaluate the ePTFE peritoneal onlay laparoscopic inguinal hernioplasty. A total of 441 inguinal hernias were repaired in 351 patients (326 male; 25 female). Two hundred twenty-six of the hernias were direct, 185 indirect, 4 femoral, 26 pantaloon, 90 bilateral, and 92 recurrent. Standardized data collection forms were used and submitted for centralized data analysis. For the hernioplasty, Cooper's ligament was exposed and an 8 cm x 12 cm x 1 mm GORE-TEX Soft Tissue Patch was stapled circumferentially to Cooper's ligament and the endoabdominal fascia. Patients were followed at 1 week, 6 months, 1 year, and then annually. Three-month intervals were used as needed. There was a mean follow-up of 447 days, with 21% of the total repairs followed for more than 2 years and 56% for more than a year. The overall follow-up rate was 95.5%. The operative and postoperative complication rates were 0.45% and 8%, respectively. There were 17 recurrent hernias (3.8%). The range of experience among the investigators was 13 to 168 hernioplasties. With the completion of 25 cases per investigator, the recurrence rate fell to 0.39%. Postoperative analgesia averaged a 24-hr supply of medication; 12.2% of patients required no analgesia. Convalescence averaged 5.4 days, and return to work averaged 7.7 days. This multicenter trial demonstrates that the ePTFE laparoscopic peritoneal onlay inguinal hernioplasty is a safe and dependable repair, especially after the initial learning curve is surmounted.

  17. Prospective cross-sectional evaluation of the small membrane filtration method for diagnosis of pulmonary tuberculosis.

    PubMed

    Jones-López, Edward; Manabe, Yukari C; Palaci, Moises; Kayiza, Carol; Armstrong, Derek; Nakiyingi, Lydia; Ssengooba, Willy; Gaeddert, Mary; Kubiak, Rachel; Almeida Júnior, Pedro; Alland, David; Dietze, Reynaldo; Joloba, Moses; Ellner, Jerrold J; Dorman, Susan E

    2014-07-01

    Smear microscopy has suboptimal sensitivity, and there is a need to improve its performance since it is commonly used to diagnose tuberculosis (TB). We prospectively evaluated the diagnostic accuracy of the small membrane filtration (SMF) method, an approach that uses a vacuum manifold and is designed to concentrate bacilli onto a filter that can be examined microscopically. We enrolled hospitalized adults suspected to have pulmonary TB in Kampala, Uganda. We obtained a clinical history and three spontaneously expectorated sputum specimens for smear microscopy (direct, concentrated, and SMF), MGIT (mycobacterial growth indicator tube) 960 and Lowenstein-Jensen (LJ) cultures, and Xpert MTB/RIF testing. We performed per-specimen (primary) and per-patient analyses. From October 2012 to June 2013, we enrolled 212 patients (579 sputum specimens). The participants were mostly female (63.2%), and 81.6% were HIV infected; their median CD4 cell count was 47 cells/μl. Overall, 19.0%, 20.4%, 27.1%, 25.2%, and 25.9% of specimens tested positive by direct smear, concentrated smear, MGIT culture, LJ culture, and Xpert test, respectively. In the per-specimen analysis, the sensitivity of the SMF method (48.5%; 95% confidence interval [CI], 37.4 to 59.6) was lower than those of direct smear (60.9%; 51.4 to 70.5 [P = 0.0001]) and concentrated smear (63.3%; 53.6 to 73.1 [P < 0.0001]). Subgroup analyses showed that SMF performed poorly in specimens having a low volume or low bacterial load. The SMF method performed poorly compared to standard smear techniques and was sensitive to sample preparation techniques. The optimal laboratory SMF protocol may require striking a fine balance between sample dilution and filtration failure rate.

  18. Prospective Cross-Sectional Evaluation of the Small Membrane Filtration Method for Diagnosis of Pulmonary Tuberculosis

    PubMed Central

    Manabe, Yukari C.; Palaci, Moises; Kayiza, Carol; Armstrong, Derek; Nakiyingi, Lydia; Ssengooba, Willy; Gaeddert, Mary; Kubiak, Rachel; Almeida Júnior, Pedro; Alland, David; Dietze, Reynaldo; Joloba, Moses; Ellner, Jerrold J.; Dorman, Susan E.

    2014-01-01

    Smear microscopy has suboptimal sensitivity, and there is a need to improve its performance since it is commonly used to diagnose tuberculosis (TB). We prospectively evaluated the diagnostic accuracy of the small membrane filtration (SMF) method, an approach that uses a vacuum manifold and is designed to concentrate bacilli onto a filter that can be examined microscopically. We enrolled hospitalized adults suspected to have pulmonary TB in Kampala, Uganda. We obtained a clinical history and three spontaneously expectorated sputum specimens for smear microscopy (direct, concentrated, and SMF), MGIT (mycobacterial growth indicator tube) 960 and Lowenstein-Jensen (LJ) cultures, and Xpert MTB/RIF testing. We performed per-specimen (primary) and per-patient analyses. From October 2012 to June 2013, we enrolled 212 patients (579 sputum specimens). The participants were mostly female (63.2%), and 81.6% were HIV infected; their median CD4 cell count was 47 cells/μl. Overall, 19.0%, 20.4%, 27.1%, 25.2%, and 25.9% of specimens tested positive by direct smear, concentrated smear, MGIT culture, LJ culture, and Xpert test, respectively. In the per-specimen analysis, the sensitivity of the SMF method (48.5%; 95% confidence interval [CI], 37.4 to 59.6) was lower than those of direct smear (60.9%; 51.4 to 70.5 [P = 0.0001]) and concentrated smear (63.3%; 53.6 to 73.1 [P < 0.0001]). Subgroup analyses showed that SMF performed poorly in specimens having a low volume or low bacterial load. The SMF method performed poorly compared to standard smear techniques and was sensitive to sample preparation techniques. The optimal laboratory SMF protocol may require striking a fine balance between sample dilution and filtration failure rate. PMID:24808236

  19. The Bo-RBC-SCID mouse model for evaluating the efficacy of anti-theilerial drugs.

    PubMed

    Hagiwara, K; Tsuji, M; Ishihara, C; Tajima, M; Kurosawa, T; Iwai, H; Takahashi, K

    1993-02-01

    We have previously developed a mouse model which allowed the proliferation of Theileria sergenti in severe combined immunodeficiency (SCID) mice with circulating bovine erythrocytes (Bo-RBC). In the present study, this model was utilized to test the efficacy of anti-theilerial drugs. Bo-RBC-SCID mice were created by giving periodic transfusions of T. sergenti-free Bo-RBC, and subsequently infecting with T. sergenti. Three anti-protozoal compounds, Pamaquine (Yamanouchi Pharmaceutical Co. Ltd), Ganaseg (Japan CIBA-GEIGY Ltd) and Buparvaquone (Coopers Animal Health Ltd), were subcutaneously administered into the mice at doses recommended for cattle therapy. Blood examinations demonstrated that all three drugs significantly reduced the level of parasitemia although Ganaseg was effective only at a dose five times higher than that recommended for cattle therapy. Administration of the drugs neither caused any sign of acute toxicity nor changed the rate of Bo-RBC in the SCID mice's circulating blood cells. The results indicate that the Bo-RBC-SCID mouse model may offer a useful in vivo system for evaluating the efficacy of anti-protozoal drugs against T. sergenti.

  20. Non-interventional study evaluating efficacy and tolerability of rifaximin for treatment of uncomplicated diverticular disease.

    PubMed

    Stallinger, Sylvia; Eller, Norbert; Högenauer, Christoph

    2014-01-01

    Patients with symptomatic uncomplicated diverticular disease represent a spectrum of patients who report recurrent abdominal symptoms, however are lacking substantial colonic inflammation in contrast to patients with acute diverticulitis. This non-interventional study investigated the efficacy and tolerability of rifaximin, a broad-spectrum poorly absorbable antibiotic, in cyclic treatment of these patients. Adult patients with uncomplicated diverticular disease in care of physicians in private practice intended to be treated with rifaximin were included. Patients with acute diverticulitis and symptoms suggestive of more severe intestinal inflammation were excluded. Data of 1,003 patients treated in cycles of 7-10 days per month over a period of 3 months were evaluated. In total, 75 % of patients had more than three episodes of symptoms in the last year before inclusion in the study. However, two-third of patients did not receive any treatment before. Over the 3-month treatment period with rifaximin, all assessed symptoms of diverticular disease, such as abdominal pain, diarrhoea and flatulence, improved significantly. There was an overall good compliance to the scheme of cyclic drug administration of rifaximin. During the study, 24 adverse events in 20 patients were recorded, of which 6 adverse events showed a causal relationship to the use of rifaximin (0.6 %). We conclude that cyclic rifaximin shows good clinical efficacy and tolerability in patients with symptomatic uncomplicated diverticular disease treated in a routine private practice outpatient setting.

  1. Efficacy of tocilizumab and evaluation of clinical remission as determined by CDAI and MMP-3 level.

    PubMed

    Funahashi, Keiko; Koyano, Satoru; Miura, Takako; Hagiwara, Takafumi; Okuda, Kosuke; Matsubara, Tsukasa

    2009-01-01

    Tocilizumab, a biological agent developed in Japan, is a human anti-interleukin-6 (anti-IL-6) receptor antibody. Rheumatoid arthritis improves with its use. A remission rate of 59% is attainable, as measured by disease activity score 28 (DAS28) in the SAMURAI study. However, in tocilizumab treatment, C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) levels drop to negative values; therefore we sought to utilize a different index for measuring its efficacy. In order to evaluate the effects of tocilizumab we carried out this study using clinical disease activity index (CDAI), as it is not reliant on blood data and would also allow us to determine which markers are present in remission. Twenty-two patients under treatment with tocilizumab participated in this study. Effects of treatment as well as the remission rate were measured by CDAI and DAS28 3 months after initiation of treatment. IL-6 and matrix metalloproteinase-3 (MMP-3) levels were measured at the same time. We studied the clinical efficacy of tocilizumab using DAS28 after treatment; remission as measured by DAS28 was 57.1% at 1 year. However, the remission rate as measured by CDAI was only 19.1% at 1 year. CDAI was not only correlated with DAS28, but also other clinical variables, MMP-3, and IL-6. We conclude that CDAI is effective in measuring clinical response to tocilizumab treatment, and that MMP-3 level is as useful as IL-6 level as an indicator.

  2. Efficacy evaluation of a multifunctional cosmetic formulation: the benefits of a combination of active antioxidant substances.

    PubMed

    Gianeti, Mirela D; Maia Campos, Patrícia M B G

    2014-11-10

    This study presents the association of active antioxidants substances in a multifunctional cosmetic formulation with established efficacy against signs of aging. A multifunctional cosmetic formulation containing an association of UV filters and antioxidant substances (liposoluble vitamins A, C and E, Ginkgo biloba and Phorphyra umbilicalis extracts) was evaluated. This formulation was submitted to a clinical efficacy study using biophysics techniques and skin images analysis (digital photography imaging systems, 20 MHz ultrasound, and reflectance confocal microscopy). The volunteers applied the formulation containing the UV filters and antioxidant substances during the day and the formulation with antioxidant substances and without the UV filters at night, for 90 days. The formulation increased the hydration and protected the skin barrier function after a single application. At the long term assessment the formulation provided an improvement in skin barrier function and skin hydration to the deeper layers of the epidermis, leading to an improvement in skin appearance by reducing wrinkles and skin roughness. The multifunctional cosmetic formulation studied can be suggested to preventing signs of aging and improving skin conditions. In addition, this study presents the benefits of associating different active antioxidants substances in a single cosmetic formulation to prevent skin aging.

  3. Effect of low-dose citrate anticoagulation on the clinical safety and efficacy of direct adsorption of lipoproteins (DALI apheresis) in hypercholesterolemic patients: a prospective controlled clinical trial.

    PubMed

    Bosch, T; Heinemann, O; Duhr, C; Wendler, T; Keller, C; Fink, E; Kirschner, T; Klebert, S; Samtleben, W

    2000-10-01

    Direct adsorption of lipoproteins (DALI) is the first lipid apheresis system compatible with whole blood with the advantage of a very simple procedure. A mixture of heparin plus citrate (ACD-A) is used for the anticoagulation regimen (AR). A clinical, prospective, controlled crossover study was performed to test the safety and efficacy of low-dose citrate (LDC) anticoagulation in DALI. Five chronic DALI patients suffering from coronary heart disease and hypercholesterolemia underwent 3 DALI sessions each using the LDC anticoagulation regimen (60 IU heparin/kg body weight as initial bolus; 1:40 ACD-A: blood as perfusion). This was compared to 3 sessions per patient with the standard AR (bolus of 20 IU heparin/kg, 1:20 ACD-A as perfusion). Patient blood volumes (1.6; average of 7,040 ml) were treated with 750 ml adsorber gel per session at a blood flow rate of 60 ml/min. Mean LDL and Lp(a) reductions exceeded 60% with both AR. No clinical side effects were observed. Both AR controlled the coagulation well as evidenced by a sufficient prolongation of the partial prothrombin time (PTT) and activated clotting time as well as low thrombin-antithrombin (TAT) formation. Biocompatibility parameters exhibited favorable results (low activation of complement and cells, and only slight formation of C3a, C5a, beta-thromboglobulin, elastase, and TNF-alpha). The asymptomatic bradykinin generation was comparable in both study arms. LDC optimized the ionized calcium levels and pH in the efferent blood postadsorber. LDC anticoagulation was safe and effective, and may further improve the tolerance of DALI apheresis in hypercholesterolemic patients.

  4. Comparing the hydrosurgery system to conventional debridement techniques for the treatment of delayed healing wounds: a prospective, randomised clinical trial to investigate clinical efficacy and cost-effectiveness.

    PubMed

    Liu, Jing; Ko, Jason H; Secretov, Erwin; Huang, Eric; Chukwu, Christiana; West, Julie; Piserchia, Katherine; Galiano, Robert D

    2015-08-01

    In these uncertain times of high health care costs, clinicians are looking for cost-effective devices to employ in their everyday practices. In an effort to promote cost-effective and proper wound repair, the hydrosurgical device allows accurate debridement of only unwanted tissue while precisely conserving viable structures for eventual repair. This prospective, randomised study compared procedures using the hydrosurgery system (VERSAJET™) with conventional debridement in order to assess clinical efficacy and cost-effectiveness when treating subjects with chronic wounds. A total of 40 subjects were recruited. There was no difference in time to achieve stable wound closure between the treatment groups (P = 0·77). There were no significant differences between the two groups in terms of cost of the first operative procedure (P = 0·28), cost of surgical procedures during the study (P = 0·51), cost of study treatment (P = 0·29) or cost to achieve stable wound closure (P = 0·85). There were no differences in quantitative bacterial counts after debridement with either methods (P = 0·376). However, the time taken for the first excision procedure was significantly faster using the hydrosurgery system (VERSAJET) when compared with conventional debridement (P < 0·001). The total excision time for all procedures was significantly less for the Hydrosurgery group than for the conventional group (P = 0·005). Also, the Hydrosurgery group demonstrated significantly less intraoperative blood loss than conventional group for all procedures (P = 0·003). In this study, although there were no differences in time to stable wound closure or bacterial reduction between the two groups, the hydrosurgery system (VERSAJET) did offer advantages in terms of operative times and intraoperative blood loss and was cost-neutral, despite the handpiece cost.

  5. Evaluation of the Safety and Efficacy of the FAAH Inhibitor URB597

    DTIC Science & Technology

    2016-01-01

    Evaluation2of2the2Safety2and2Efficacy2of2the2FAAH2Inhibitor2URB597 ! ! ! PRINCIPAL!INVESTIGATOR:!!!Alexander2Neumeister! ! ! ! CONTRACTING!ORGANIZATION:!New2York2University New York, NY 10016...nyumc.org! ! ! 5f.2WORK2UNIT2NUMBER 7.2PERFORMING2ORGANIZATION2NAME(S)2AND2ADDRESS(ES)2 New York University 550 First Avenue & One Park Avenue, Room 8...225 New York, New York 10016 8.2PERFORMING2ORGANIZATION2REPORT222 2222NUMBER 9.2SPONSORING2/2MONITORING2AGENCY2NAME(S)2AND2ADDRESS(ES

  6. Detoxification of organophosphorus pesticides and nerve agents through RSDL: efficacy evaluation by (31)P NMR spectroscopy.

    PubMed

    Elsinghorst, Paul W; Worek, Franz; Koller, Marianne

    2015-03-04

    Intoxication by organophosphorus compounds, especially by pesticides, poses a considerable risk to the affected individual. Countermeasures involve both medical intervention by means of antidotes as well as external decontamination to reduce the risk of dermal absorption. One of the few decontamination options available is Reactive Skin Decontamination Lotion (RSDL), which was originally developed for military use. Here, we present a (31)P NMR spectroscopy based methodology to evaluate the detoxification efficacy of RSDL with respect to a series of organophosphorus pesticides and nerve agents. Kinetic analysis of the obtained NMR data provided degradation half-lives proving that RSDL is also reasonably effective against organophosphorus pesticides. Unexpected observations of different RSDL degradation patterns are presented in view of its reported oximate-catalyzed mechanism of action.

  7. Evaluation of antiviral efficacy against human respiratory syncytial virus using cotton rat and mouse models.

    PubMed

    Van den Berg, Joke; Kwanten, Leen; Roymans, Dirk

    2013-01-01

    Infection with human respiratory syncytial virus (hRSV) causes a wide spectrum of respiratory disease in infants, young children, and elderly persons. No vaccine is available today and hRSV treatment options are limited. As a consequence, the treatment of hRSV infection remains largely supportive and new therapeutic options are needed to treat severe lower respiratory tract hRSV disease. Several animal models have been developed to study hRSV disease and evaluate novel therapies or preventive measures such as vaccines. However, each of these models reproduces different aspects of hRSV disease, and therefore, an appropriate model should be selected on the basis of the scientific question under investigation. In this chapter, we describe how cotton rats and Balb/c mice are used in our laboratory to test the in vivo efficacy of small-molecule inhibitors against hRSV.

  8. Using a mathematical model to evaluate the efficacy of TB control measures.

    PubMed Central

    Gammaitoni, L.; Nucci, M. C.

    1997-01-01

    We evaluated the efficacy of recommended tuberculosis (TB) infection control measures by using a deterministic mathematical model for airborne contagion. We examined the percentage of purified protein derivative conversions under various exposure conditions, environmental controlstrategies, and respiratory protective devices. We conclude that environmental control cannot eliminate the risk for TB transmission during high-risk procedures; respiratory protective devices, and particularly high-efficiency particulate air masks, may provide nearly complete protection if used with air filtration or ultraviolet irradiation. Nevertheless, the efficiency of these control measures decreases as the infectivity of the source case increases. Therefore, administrative control measures (e.g., indentifying and isolating patients with infectious TB) are the most effective because they substantially reduce the rate of infection. PMID:9284378

  9. SU-F-18C-06: Prospective Patient Evaluation of Iterative Reconstruction in Radiation Oncology

    SciTech Connect

    Price, R; Vance, S; Cattaneo, R; Schultz, L; Elshaikh, M; Chetty, I; Glide-Hurst, C

    2014-06-15

    Purpose: This work incorporates iterative reconstruction (IR) into a dose reduction study to characterize image quality metrics, delineation, and dosimetric assessment, with the goal of reducing imaging dose in Radiation Oncology. Methods: Three-dimensional noise power spectrum (NPS) analysis characterized noise magnitude/texture (120 kVp, 50–200 mAs, IR levels 1–6 yielding noise reduction of 0.89–0.55 compared to filtered backprojection (FBP)). Task-specific Modulation Transfer Functions (MTFtask) were characterized across varied subject contrasts. A prospective dose reduction study (500 to 150 mAs) was conducted for 12 patients (43 inter-fraction CTs) for high-dose rate brachytherapy. Three physicians performed qualitative image assessment between full-dose FBP (FD-FBP, 500 mAs), low-dose FBP (LD-FBP, 150–250 mAs), and low-dose IRL5-6 (LD-IR) scans for image noise, cuff/bladder interface detectability, spatial resolution, texture, and segmentation confidence. Comparisons between LD-FBP and LD-IR were conducted for the following metrics: delineation (bladder and rectum evaluated via overlap indices (OI) and Dice similarity coefficients (DSC)), noise, boundary changes, dose calculation, and digitally reconstructed radiographs (DRRs). Results: NPS showed ∼50% reduction in noise magnitude and ∼0.1 1/mm spatial frequency shift with IRL6. The largest MTFtask decrease between FBP and IR was 0.08 A.U. Qualitative patient image evaluation revealed LD-IR was equivalent or slightly worse than FD-FBP, and superior to LD-FBP for all metrics except low contrast interface and texture. The largest CT number discrepancy from FBP occurred at a bone/tissue interface using IRL6 (−1.2 ± 4.9 HU (range: −17.6 – 12.5 HU)). No significant contour differences (OIs and DSCs = 0.85 – 0.95) and dose calculation discrepancy (<0.02%) were observed. DRRs preserved anatomical detail and demonstrated <2% difference in intensity between LD-FBP and LD-IRL6. Conclusion: While

  10. 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.

  11. Evaluation of Nd:YAG laser device efficacy on onychomycosis: a case series of 30 patients.

    PubMed

    Helou, J; Maatouk, I; Hajjar, M A; Moutran, R

    2016-01-01

    Until recently, pharmacologic molecules have been the only available treatments for onychomycosis. Laser treatments were introduced for recurrent or resistant cases or in patients in whom oral treatments are contra-indicated. Some devices were approved by the Food and Drug Administration (FDA). Neodymium yttrium aluminium garnet (Nd:YAG) is used for onychomycosis as a short-pulse or a long-pulse system. We aim to evaluate the efficacy of the short-pulse Nd:YAG in treating onychomycosis, its side effects, cure rates, and 12-month recurrence rates. Efficacy was evaluated based on a subjective measure of patient satisfaction on a scale from 1 to 10, and an objective measure based on the results of the mycologic cultures. Medical records of 30 patients were reviewed. Ages ranged from 22 to 85, with a mean of 44. Mycologic cure at 12 months was not achieved in 5 patients (16.67%) who had received laser treatment. None of these patients showed any signs of clinical improvement. Twenty patients (66.67%) were completely cured at 12 months, with corroborating negative mycologic cultures. The remaining five patients (16.67%) had discordance between their clinical cure status and their mycologic cultures. Side effects were reported by 7 patients out of 30 (33%): pain within 48 hours of the treatment session, burning sensation in the treated nail bed area. Our primary end point of negative mycologic cultures at 12 months was seen in 24 out of 30 (80%) of our patients. Similar culture cure rates have not been reported before, not even with systemic treatments with oral antifungals. However, few limitations should warrant us (False-negative results in fungal cultures; time limitation; sample size…). Still, we propose that this alternative should be offered for patients in whom antifungals are contraindicated or for patients previously treated, but not cured by oral antifungals, and in elderly and polymedicated patients.

  12. Evaluating the Efficacy of a Sternocleidomastoid Flap via Galvanic Skin Responses in Superficial Parotidectomy.

    PubMed

    Basut, Oguz; Noyan, Behzat; Demirci, Ugur

    2014-01-01

    In the present study, we evaluated the efficacy of flaps via measurement of galvanic skin responses (GSR) in patients who had undergone superficial parotidectomy either with or without sternocleidomastoid (SCM) muscle flaps. Retrospective study design was used. The setting included University of Uludag School of Medicine Department of Otorhinolaryngology. Eleven patients who had undergone superficial parotidectomy for benign diseases in our clinic between June 2003 and August 2006 were included in the study. SCM muscle flaps were used in four patients. The GSR of the patients were measured using a MP 30 System. The Mann-Whitney U test was used for the analysis of data. There were complaints that resembled Frey's syndrome in three patients in whom flaps had not been performed. Patients with flaps had no complaints. In patients with flaps, no significant GSR changes were observed between the control and operated sides (P > 0.05). In patients without flaps, the GSR levels were significantly higher on the operated side compared to the control side (P < 0.05). GSR values on the control side did not show any differences between patients with and without a flap. However, there were significantly higher GSR values for the operated side in patients without flaps compared to patients with flaps (P < 0.05). Application of a SCM flap is an efficient method by which to prevent Frey's syndrome, and the GSR test is beneficial both in diagnosiing and determining the severity of the disease as well as evaluating the efficacy of surgical techniques used to prevent Frey's syndrome.

  13. Evaluation of efficacy and safety of finasteride 1 mg in 3177 Japanese men with androgenetic alopecia.

    PubMed

    Sato, Akio; Takeda, Akira

    2012-01-01

    Before now, there has been no study of finasteride use exceeding 1 year in Japanese men with androgenetic alopecia (AGA) except the study subsequently conducted from the development phase. Since the launch of finasteride, no study in a larger population had been reported. Ethnic variation of the onset age, progressive nature and degree of hair loss of androgenetic alopecia are known. The therapeutic effect of oral finasteride (Propecia) was examined on androgenetic alopecia of Japanese men. The efficacy and safety of finasteride (1 mg tablet) was evaluated in Japanese men with AGA in the long term. The study enrolled 3177 men given finasteride 1 mg/day from January 2006 to June 2009 at our clinic. Efficacy was evaluated in 2561 men by the modified global photographic assessment; the photographs were assessed using the standardized 7-point rating scale. Safety data were assessed by interviews and laboratory tests in all men enrolled in the study. The overall effect of hair growth was seen in 2230 of 2561 men (87.1%), in whom hair greatly (11.1%), moderately (36.5%) and slightly (39.5%) increased. The response rate improved with increasing duration of treatment. Adverse reactions occurred in 0.7% (23/3177) of men; seven men discontinued treatment based on risk-benefit considerations. No specific safety problems associated with long-term use were observed. This study represents data collected at a single institution. Many patients did not receive follow-up examination. In Japanese men with AGA, oral finasteride used in the long-term study maintained progressive hair regrowth without recognized side-effect.

  14. Evaluation of the therapeutic efficacy of Mentha crispa in the treatment of giardiasis.

    PubMed

    Teles, Naracélia S B; Fechine, Francisco V; Viana, Fernando André C; Viana, Ismenia O L; Nascimento, Demétrius F; Leite, Ana Lourdes A S; Bezerra, Fernando Antônio Frota; Moraes, Manoel Odorico; Moraes, Maria Elisabete A

    2011-11-01

    It's estimated that around 200 million people are annually infected with Giardia lamblia, making the disease a major cause of morbidity worldwide. The current treatment of giardiasis includes the use of several drugs, among them, herbal medicines formulated with Mentha crispa. Thus, the purpose of this study was to evaluate the therapeutic efficacy of M. crispa in the treatment of giardiasis. The research consisted initially of a cross-sectional study for the selection of subjects with giardiasis. After that, there was a randomized, open, in parallel with active control study, in order to verify the therapeutic efficacy of M. crispa in the treatment of giardiasis. Coprology samples were collected from 1622 patients between May 2005 and May 2007 for a series of parasitological examinations. Ninety-six patients with G. lamblia were selected, which were then distributed randomly into two groups: Secnidazole, consisting of 50 patients treated with 2g of Secnidazole and M. crispa, containing 46 patients treated with 2g of M. crispa. After 7 days, healing was evaluated by enzyme immunoassay in a fresh fecal sample. Additionally, the subjects were questioned about possible adverse effects and answered a questionnaire covering socioeconomic and hydrosanitary issues. The analysis of the clinical trial data showed that the cure rate for the Secnidazole group (84.0%) was significantly higher (P=0.0002) as that verified in the M. crispa group (47.83%). Therefore, the study concludes that, in the dose used in this trial, the effect of M. crispa in the treatment of giardisis is less effective than that of Secnidazole.

  15. Radiofrequency ablation of benign thyroid nodules: evaluation of the treatment efficacy using ultrasonography

    PubMed Central

    2016-01-01

    Purpose: The aim of this study was to evaluate the efficacy of radiofrequency (RF) ablation for benign thyroid nodules and assess the usefulness of internal factors (ultrasonographic findings) and external factors (treatment-related findings) in prediction of treatment efficacy. Methods: We evaluated 22 benign thyroid nodules from 19 patients treated with RF ablation between March 2010 and January 2013. The internal and external factors of these nodules were retrospectively reviewed and correlated with the therapeutic success and the volume reduction ratio (VRR). The volume and size of the nodules were determined before treatment, and the VRR was calculated at 6-month and 1-year follow-up examinations after RF ablation. Therapeutic success was defined as a >50% volume reduction. Results: The mean VRRs were 66.1±18.7% at 6 months and 74.3±16.7% at 1 year. The therapeutic success rate after 6 months and 1 year was 81.8% and 90.9%, respectively. At the 1-year follow-up, the margin of the nodule correlated with therapeutic success. Most of the successfully ablated nodules showed well-defined margins on initial ultrasonography (18/20, 90%) (P=0.026). In addition, nodules with ill-defined margins showed a tendency toward having a low VRR at the 6-month and 1-year follow-up examinations. Conclusion: RF ablation was effective in decreasing the volume of benign thyroid nodules. Thyroid nodules with well-defined margins tended to show successful outcomes at the 1-year follow-up examination after RF ablation. PMID:27101983

  16. Using Small-Scale Randomized Controlled Trials to Evaluate the Efficacy of New Curricular Materials

    PubMed Central

    Bass, Kristin M.; Stark, Louisa A.

    2014-01-01

    How can researchers in K–12 contexts stay true to the principles of rigorous evaluation designs within the constraints of classroom settings and limited funding? This paper explores this question by presenting a small-scale randomized controlled trial (RCT) designed to test the efficacy of curricular supplemental materials on epigenetics. The researchers asked whether the curricular materials improved students’ understanding of the content more than an alternative set of activities. The field test was conducted in a diverse public high school setting with 145 students who were randomly assigned to a treatment or comparison condition. Findings indicate that students in the treatment condition scored significantly higher on the posttest than did students in the comparison group (effect size: Cohen's d = 0.40). The paper discusses the strengths and limitations of the RCT, the contextual factors that influenced its enactment, and recommendations for others wishing to conduct small-scale rigorous evaluations in educational settings. Our intention is for this paper to serve as a case study for university science faculty members who wish to employ scientifically rigorous evaluations in K–12 settings while limiting the scope and budget of their work. PMID:25452482

  17. Technology Efficacy in Active Prosthetic Knees for Transfemoral Amputees: A Quantitative Evaluation

    PubMed Central

    El-Sayed, Amr M.; Abu Osman, Noor Azuan

    2014-01-01

    Several studies have presented technological ensembles of active knee systems for transfemoral prosthesis. Other studies have examined the amputees' gait performance while wearing a specific active prosthesis. This paper combined both insights, that is, a technical examination of the components used, with an evaluation of how these improved the gait of respective users. This study aims to offer a quantitative understanding of the potential enhancement derived from strategic integration of core elements in developing an effective device. The study systematically discussed the current technology in active transfemoral prosthesis with respect to its functional walking performance amongst above-knee amputee users, to evaluate the system's efficacy in producing close-to-normal user performance. The performances of its actuator, sensory system, and control technique that are incorporated in each reported system were evaluated separately and numerical comparisons were conducted based on the percentage of amputees' gait deviation from normal gait profile points. The results identified particular components that contributed closest to normal gait parameters. However, the conclusion is limitedly extendable due to the small number of studies. Thus, more clinical validation of the active prosthetic knee technology is needed to better understand the extent of contribution of each component to the most functional development. PMID:25110727

  18. Development and Evaluation of Mouth Dissolving Films of Amlodipine Besylate for Enhanced Therapeutic Efficacy

    PubMed Central

    Maheswari, K. M.; Devineni, Pavan Kumar; Deekonda, Sravanthi; Shaik, Salma; Uppala, Naga Pravallika; Nalluri, Buchi N.

    2014-01-01

    The present investigation was undertaken with an objective of formulating mouth dissolving films (MDFs) of Amlodipine Besylate (AMLO) to enhance convenience and compliance of the elderly and pediatric patients for better therapeutic efficacy. Film formers like hydroxy propyl methyl cellulose (HPMC) and methyl cellulose (MC) along with film modifiers like poly vinyl pyrrolidone K30 (PVP K30), and sodium lauryl sulphate (SLS) as solubilizing agents were evaluated. The prepared MDFs were evaluated for in vitro dissolution characteristics, in vitro disintegration time, and their physicomechanical properties. All the prepared MDFs showed good mechanical properties like tensile strength, folding endurance, and % elongation. MDFs were evaluated by means of FTIR, SEM, and X-RD studies. MDFs with 7.5% (w/w) of HPMC E3 gave better dissolution properties when compared to HPMC E5, HPMC E15, and MC. MDFs with PVP K30 and SLS gave superior dissolution properties when compared to MDFs without PVP K30 and SLS. The dissolution properties of MDFs with PVP K30 were superior when compared to MDFs with SLS. In the case of F3 containing 7.5% of HPMC E3 and 0.04% of PVP K30, complete and faster release was observed within 60 sec when compared to other formulations. Release kinetics data reveals diffusion is the release mechanism. PMID:26556197

  19. Antifungal Lock Therapy with Liposomal Amphotericin B: A Prospective Trial.

    PubMed

    McGhee, William; Michaels, Marian G; Martin, Judith M; Mazariegos, George V; Green, Michael

    2016-03-01

    We conducted a prospective pilot study to evaluate the potential role of combined systemic antifungal and liposomal amphotericin B lock therapy in children with intestinal insufficiency with fungal catheter-related bloodstream infections whose central venous catheters had not been removed. Our results provide supportive evidence for the conduct of larger clinical trials to confirm the efficacy and safety of this approach.

  20. Comparative efficacy of nimesulide and ketoprofen on inflammatory events in third molar surgery: a split-mouth, prospective, randomized, double-blind study.

    PubMed

    Pouchain, E C; Costa, F W G; Bezerra, T P; Soares, E C S

    2015-07-01

    This study aimed to compare the effect of nimesulide and ketoprofen on inflammatory parameters related to the surgical removal of third molars. A split-mouth, prospective, randomized, double-blind study was conducted in patients undergoing removal of four third molars. Eighteen eligible patients were allocated to one of two groups to receive treatment two times a day with either ketoprofen 100 mg or nimesulide 100 mg for a period of 3 days. The rescue medication intake (number) and pain intensity were evaluated at 6, 12, 24, and 48 h, and at 7 days postoperatively. Swelling and maximum mouth opening were evaluated at 24 h, 72 h, and 7 days postoperatively. The peak pain score occurred at 6h after surgery in the nimesulide group and at 12h in the ketoprofen group. There was no statistically significant difference between the groups, although pain relief was observed after 48 h in the nimesulide group and after 7 days in the ketoprofen group. For each group, there was a statically significant difference in pain scores among the studied periods (P<0.0001). None of the patients required rescue medication. There was a statistically significant difference in maximum mouth opening between the preoperative and postoperative periods (P<0.0001). Ketoprofen and nimesulide were effective at controlling pain, swelling, and trismus after the surgical removal of third molars.

  1. Evaluation of factors predicting clinical pleural injury during percutaneous nephrolithotomy: a prospective study.

    PubMed

    Sharma, Kuldeep; Sankhwar, Satya Narayan; Singh, Vishwajeet; Singh, Bhupendra Pal; Dalela, Diwakar; Sinha, Rahul Janak; Kumar, Manoj; Singh, Manmeet; Goel, Apul

    2016-06-01

    The purpose of this study is to prospectively identify factors that predict the chance of pleural injury (detected clinically or on postoperative X-ray chest) during percutaneous nephrolithotomy (PCNL). All patients with renal/upper ureteric stones, undergoing PCNL between January 2013 and June 2014, were evaluated for pleural injury. An erect chest X-ray on inspiration was done within 6 h of PCNL. The patients were divided into Groups A and B depending on whether they developed or did not develop pleural injury. Patient-, stone-, renal-, and procedure-related factors were compared between the two groups. 332 patients with mean age 36.76 ± 15.01 years (range 4-80) and M:F of 172:160 fulfilled the inclusion criteria. Pleural complications occurred in 10 patients (3 %). Of 141 patients with supracostal punctures (59 had additional infracostal punctures), 4.2 % (n = 6) had pleural injury. Of 191 patients with only infracostal punctures, 4 developed pleural injuries (2 %). Patients in group A had significantly lower age (27.00 ± 11.18 vs. 37.06 ± 15.03, p = 0.03) and lower BMI (18.0 ± 1.90 vs. 21.12 ± 2.24 p = 0.002). Incidence of pleural injury was significantly higher (p = 0.001) on right side [4.0 % (7/172) vs. 1.8 %, 3/160)]. Incidence of pleural injury had no association with staghorn calculi, stone surface area (590.51 ± 313.88 for Group A vs. 593.02 ± 387.10 for Group B; p = 0.11), degree of hydronephrosis, and operative time (65.13 ± 19.45 for Group A vs. 72.21 ± 19.56 for Group B; p = 0.06). On multivariate analysis, only low BMI and mean age <27 years were associated with higher risk of pleural injury. Higher incidence of pleural injury was noted in patients with low BMI and younger age.

  2. Is Collective Efficacy Age Graded? The Development and Evaluation of a New Measure of Collective Efficacy for Older Adults

    PubMed Central

    Galinsky, Adena M.; Cagney, Kathleen A.; Browning, Christopher R.

    2012-01-01

    Objectives. Community processes are key determinants of older adults' ability to age in place, but existing scales measuring these constructs may not provide accurate, unbiased measurements among older adults because they were designed with the concerns of child-rearing respondents in mind. This study examines the properties of a new theory-based measure of collective efficacy (CE) that accounts for the perspectives of older residents. Methods. Data come from the population-based Chicago Neighborhood Organization, Aging and Health study (N = 1,151), which surveyed adults aged 65 to 95. Using descriptive statistics, correlations, and factor analysis, we explored the acceptability, reliability, and validity of the new measure. Results. Principal component analysis indicated that the new scale measures a single latent factor. It had good internal consistency reliability, was highly correlated with the original scale, and was similarly associated with neighborhood exchange and disorder, self-rated health, mobility, and loneliness. The new scale also showed less age-differentiated nonresponse compared to the original scale. Discussion. The older adult CE scale has reliability and validity equivalent to that of the existing measure but benefits from a more developed theoretical grounding and reduced likelihood of age-related differential nonresponse. PMID:22315685

  3. Prospective Evaluation of Mesopic Night Vision and Night Vision Goggle Visual Acuity After Photorefractive Keratectomy (PRK)

    DTIC Science & Technology

    2005-03-01

    DTIC) should direct requests for copies to: Defense Technical Information Center, 8725 John J. Kingman Rd., STE 0944, Ft. Belvior, VA 22060-6218. Non...770-6. 9. Verdon W, Bullimore M, Maloney RK. Visual Performance after Photorefractive Keratectomy. A Prospective Study. Arch Ophthalmol. December

  4. Safety and efficacy of intravesical alum for intractable hemorrhagic cystitis: a contemporary evaluation

    PubMed Central

    Westerman, Mary E.; Boorjian, Stephen A.; Linder, Brian J.

    2016-01-01

    ABSTRACT Introduction: Hemorrhagic cystitis (HC) represents a challenging clinical entity. While various intravesical agents have been utilized in this setting, limited data exist regarding safety or efficacy. Herein, then, we evaluated the effectiveness and complications associated with intravesical alum instillation for HC in a contemporary cohort. Materials and Methods: We identified 40 patients treated with intravesical alum for HC between 1997-2014. All patients had failed previous continuous bladder irrigation with normal saline and clot evacuation. Treatment success was defined as requiring no additional therapy beyond normal saline irrigation after alum instillation. Results: Median patient age was 76.5 years (IQR 69, 83). Pelvic radiation was the most common etiology for HC (n=38, 95%). Alum use decreased patient's transfusion requirement, with 82% (32/39) receiving a transfusion within 30 days before alum instillation (median 4 units) versus 59% (23/39) within 30 days after completing alum (median 3 units) (p=0.05). In total, 24 patients (60%) required no additional therapy prior to hospital discharge. Moreover, at a median follow-up of 17 months (IQR 5, 38.5), 13 patients (32.5%) remained without additional treatment for HC. Adverse effects were reported in 15 patients (38%), with bladder spasms representing the most common event (14/40; 35%). No clinical evidence of clinically significant systemic absorption was detected. Conclusion: Intravesical alum therapy is well-tolerated, with resolution of HC in approximately 60% of patients, and a durable response in approximately one-third. Given its favorable safety/efficacy profile, intravesical alum may be considered as a first-line treatment option for patients with HC. PMID:27509371

  5. Preclinical Evaluation of the Stability, Safety, and Efficacy of CD101, a Novel Echinocandin

    PubMed Central

    Hough, Grayson; Schlosser, Michael; Bartizal, Ken; Balkovec, James M.; James, Kenneth D.; Krishnan, B. Radha

    2016-01-01

    Fungal infections pose a significant public health burden with high morbidity and mortality. CD101 is a novel echinocandin under development for the treatment and prevention of systemic Candida infections. Preclinical studies were conducted to evaluate the metabolic stability, plasma protein binding, pharmacokinetics, toxicity, and efficacy of CD101 at various dose levels. CD101 was stable to biotransformation in rat, monkey, and human liver microsomes and rat, monkey, dog, and human hepatocytes. In vitro studies suggest minimal interaction with recombinant cytochrome P450 enzymes (50% inhibitory concentrations [IC50s] of >10 μM). Similar to anidulafungin, CD101 bound avidly (>98%) to human, mouse, rat, and primate plasma proteins. In a 2-week repeat-dose comparison study, CD101 was well tolerated in rats (no effects on body weight, hematology, coagulation, or urinalysis). In contrast, administration of anidulafungin (at comparable exposure levels) resulted in reduced body weight, decreases in red blood cell, hemoglobin, hematocrit, mean cell volume, mean corpuscular hemoglobin, platelet, and reticulocyte counts, increases in neutrophil and eosinophil counts, polychromasia, and decreased activated partial thromboplastin time. Elevated plasma transaminases, total bilirubin, cholesterol, and globulin, dark and enlarged spleens, and single-cell hepatocyte necrosis were also observed for anidulafungin but not CD101. Hepatotoxicity may be due to the inherent chemical lability of anidulafungin generating potentially reactive intermediates. A glutathione trapping experiment confirmed the formation of a reactive species from anidulafungin, whereas CD101 did not exhibit instability or reactive intermediates. CD101 showed antifungal activity against Candida and Aspergillus infections in neutropenic mice. These preclinical studies demonstrated that CD101 is chemically and metabolically stable, well tolerated with no hepatotoxicity, and efficacious as an antifungal agent

  6. Direct contact membrane inoculation of yeasts and moulds for evaluating preservative efficacy in solid cosmetics.

    PubMed

    Tran, T T; Collier, S W

    1992-08-01

    Synopsis A direct contact membrane inoculation technique for yeasts and moulds was used to evaluate the preservation efficacy and antimicrobial activity of Germall 115 and Germall II in pressed eye shadows. Test organisms on membrane filters were placed in direct contact with cosmetics at room temperature under humid conditions. Growth on membranes was removed daily, or as appropriate, and cultured on potato dextrose agar containing lecithin and Tween 80. Linear regression analysis was used to determine product preservation efficacy. Average D values of 1 and 3 days for Candida albicans American Type Culture Collection (ATCC) 10231 and 17 and 29 days for Aspergillus niger ATCC 16404 were obtained on two eye shadows we prepared (in-house eye shadows) with parabens and either Germall II or Germall 115 as preservatives. A decimal reduction time (D value) of 6-7 days was calculated for the yeast on a commercial eye shadow preserved with parabens and Germall 115. A. niger multiplied on six of seven replicates of this commercial product to attain a nearly 3 log(10) increase in 20 days. On one replicate, A. niger showed a 1 log(10) increase in the first 10 days, and then decreased linearly (r =- 0.95) to <10 colony-forming units per membrane by day 24. The method used with C. albicans and A. niger was then used with bacteria. The method was sensitive enough to differentiate the antimicrobial activity of the Germall 115 and Germall II against fungi but not against bacteria. The in-house and commercial products were preserved most effectively against the three bacteria tested and least effectively against the mould.

  7. In vivo efficacy and bioavailability of lumefantrine: Evaluating the application of Pheroid technology.

    PubMed

    du Plessis, Lissinda H; Govender, Katya; Denti, Paolo; Wiesner, Lubbe

    2015-11-01

    The oral absorption of compounds with low aqueous solubility, such as lumefantrine, is typically limited by the dissolution rate in the gastro-intestinal tract, resulting in erratic absorption and highly variable bioavailability. In previous studies we reported on the ability of Pheroid vesicles to improve the bioavailability of poorly soluble drugs. In the present study a Pro-Pheroid formulation, a modification of the previous formulation, was applied to improve the solubility of lumefantrine after oral administration and compared to lumefantrine in DMSO:water (1:9 v/v) solution (reference solution). A bioavailability study of lumefantrine was conducted in a mouse model in fed and fasted states. When using the reference solution, the bioavailability of the lumefantrine heavily depended on food intake, resulting in a 2.7 times higher bioavailability in the fed state when compared to the fasted state. It also showed large between-subject variability. When formulated using Pro-Pheroid, the bioavailability of lumefantrine was 3.5 times higher as compared to lumefantrine in the reference solution and fasting state. Pro-Pheroid also dramatically reduced the effects of food intake and the between-subject variability for bioavailability observed with the reference. In vivo antimalarial efficacy was also evaluated with lumefantrine formulated using Pro-Pheroid technology compared to the reference solution. The results indicated that lumefantrine in Pro-Pheroid formulation exhibited improved antimalarial activity in vitro by 46.8%, when compared to the reference. The results of the Peters' 4-day suppressive test indicated no significant difference in the efficacy or mean survival time of the mice in the Pro-Pheroid formulation and reference test groups when compared to the positive control, chloroquine. These findings suggest that using the Pro-Pheroid formulation improves the bioavailability of lumefantrine, eliminates the food effect associated with lumefantrine as well

  8. Sunscreens, skin photobiology, and skin cancer: the need for UVA protection and evaluation of efficacy.

    PubMed

    Gasparro, F P

    2000-03-01

    Sunscreens are ultraviolet radiation (UVR)-absorbing chemicals that attenuate the amount and nature of UVR reaching viable cells in the skin. They are selected and tested for their ability to prevent erythema. No sunscreen prevents photodamage, as it has been demonstrated that suberythemal doses of UVR cause a variety of molecular changes (including DNA damage) in these cells. Furthermore, the spectrum of UVR reaching viable cells is altered by topically applied sunscreen. In this review, the basic aspects of sunscreens and skin photobiology are reviewed briefly. Although there can be no question concerning the efficacy of sunscreens for the prevention of erythema, questions remain because of the possible cumulative effects of chronic suberythemal doses and the increased exposure of skin cells to longer UVR wavelengths. The current major issue surrounding sunscreens involves their ability to protect skin cells against the effects of UVA radiation. These UVA effects may be direct damage (base oxidations) or effects on the skin immune system, yet there is no uniformly accepted method for the evaluation of UVA protection. This review is focused primarily on the latter topic covering action spectra that implicate the need for UVA protection. In addition, in vivo and in vitro methods proposed for the evaluation of candidate sunscreen formulations of UVA protective ability are reviewed. Finally, revisions in the terminology used to describe the protection afforded by sunscreens are suggested. It is proposed that SPF ("sun" protection factor) be renamed "sunburn" protection factor and that "critical wavelength" be designated "long wave index."

  9. Recent advances in evaluation of oxime efficacy in nerve agent poisoning by in vitro analysis

    SciTech Connect

    Worek, F. . E-mail: FranzWorek@Bundeswehr.org; Eyer, P.; Aurbek, N.; Szinicz, L.; Thiermann, H.

    2007-03-15

    The availability of highly toxic organophosphorus (OP) warfare agents (nerve agents) underlines the necessity for an effective medical treatment. Acute OP toxicity is primarily caused by inhibition of acetylcholinesterase (AChE). Reactivators (oximes) of inhibited AChE are a mainstay of treatment, however, the commercially available compounds, obidoxime and pralidoxime, are considered to be rather ineffective against various nerve agents, e.g. soman and cyclosarin. This led to the synthesis and investigation of numerous oximes in the past decades. Reactivation of OP-inhibited AChE is considered to be the most important reaction of oximes. Clinical data from studies with pesticide-poisoned patients support the assumption that the various reactions between AChE, OP and oxime, i.e. inhibition, reactivation and aging, can be investigated in vitro with human AChE. In contrast to animal experiments such in vitro studies with human tissue enable the evaluation of oxime efficacy without being affected by species differences. In the past few years numerous in vitro studies were performed by different groups with a large number of oximes and methods were developed for extrapolating in vitro data to different scenarios of human nerve agent poisoning. The present status in the evaluation of new oximes as antidotes against nerve agent poisoning will be discussed.

  10. Evaluation of bacteriochlorophyll-reconstituted low-density lipoprotein nanoparticles for photodynamic therapy efficacy in vivo

    PubMed Central

    Marotta, Diane E; Cao, Weiguo; Wileyto, E Paul; Li, Hui; Corbin, Ian; Rickter, Elizabeth; Glickson, Jerry D; Chance, Britton; Zheng, Gang; Busch, Theresa M

    2011-01-01

    Aim To evaluate the novel nanoparticle reconstituted bacteriochlorin e6 bisoleate low-density lipoprotein (r-Bchl-BOA-LDL) for its efficacy as a photodynamic therapy agent delivery system in xenografts of human hepatoblastoma G2 (HepG2) tumors. Materials & methods Bchl-BOA was encapsulated in the nanoparticle low-density lipoprotein (LDL), a native particle whose receptor’s overexpression is a cancer signature for a number of neoplasms. Evaluation of r-Bchl-BOA-LDL as a potential photosensitizer was performed using a tumor response and foot response assay. Results & discussion When compared with controls, tumor regrowth was significantly delayed at injected murine doses of 2 µmole/kg r-Bchl-BOA-LDL after illumination at fluences of 125, 150 or 175 J/cm2. Foot response assays showed that although normal tissue toxicity accompanied the higher fluences it was significantly reduced at the lowest fluence tested. Conclusion This research demonstrates that r-Bchl-BOA-LDL is an effective photosensitizer and a promising candidate for further investigation. PMID:21542686

  11. Sunscreens, skin photobiology, and skin cancer: the need for UVA protection and evaluation of efficacy.

    PubMed Central

    Gasparro, F P

    2000-01-01

    Sunscreens are ultraviolet radiation (UVR)-absorbing chemicals that attenuate the amount and nature of UVR reaching viable cells in the skin. They are selected and tested for their ability to prevent erythema. No sunscreen prevents photodamage, as it has been demonstrated that suberythemal doses of UVR cause a variety of molecular changes (including DNA damage) in these cells. Furthermore, the spectrum of UVR reaching viable cells is altered by topically applied sunscreen. In this review, the basic aspects of sunscreens and skin photobiology are reviewed briefly. Although there can be no question concerning the efficacy of sunscreens for the prevention of erythema, questions remain because of the possible cumulative effects of chronic suberythemal doses and the increased exposure of skin cells to longer UVR wavelengths. The current major issue surrounding sunscreens involves their ability to protect skin cells against the effects of UVA radiation. These UVA effects may be direct damage (base oxidations) or effects on the skin immune system, yet there is no uniformly accepted method for the evaluation of UVA protection. This review is focused primarily on the latter topic covering action spectra that implicate the need for UVA protection. In addition, in vivo and in vitro methods proposed for the evaluation of candidate sunscreen formulations of UVA protective ability are reviewed. Finally, revisions in the terminology used to describe the protection afforded by sunscreens are suggested. It is proposed that SPF ("sun" protection factor) be renamed "sunburn" protection factor and that "critical wavelength" be designated "long wave index." PMID:10698724

  12. Comparative evaluation of intrathecal morphine and intrathecal dexmedetomidine in patients undergoing gynaecological surgeries under spinal anaesthesia: A prospective randomised double blind study

    PubMed Central

    Kurhekar, Pranjali; Kumar, S Madan; Sampath, D

    2016-01-01

    Background and Aims: Inrathecal opioids like morphine added to local anaesthetic agents have been found to be effective in achieving prolonged post-operative analgesia. Intrathecal dexmedetomidine may be devoid of undesirable side effects related to morphine and hence, this study was designed to evaluate analgesic efficacy, haemodynamic stability and adverse effects of both these adjuvants in patients undergoing gynaecological surgeries. Methods: This was a prospective, randomised, double blind study involving 25 patients in each group. Group M received 15 mg of 0.5% hyperbaric bupivacaine with 250 μg of morphine while Group D received 15 mg of 0.5% hyperbaric bupivacaine with 2.5 μg of dexmedetomidine. Characteristics of spinal block, time for first rescue analgesic and total dose of rescue analgesics were noted. Vital parameters and adverse effects were noted perioperatively. Data analysis was done with independent two sample t-test and Mann–Whitney U test. Results: Time for first rescue analgesic (P = 0.056) and total analgesic demand were similar in both groups. Duration of sensory (P = 0.001) and motor (P = 000) block was significantly higher in dexmedetomidine group. Itching was noticed in 36% and nausea in 52% of patients in the morphine group, either of which was not seen in dexmedetomidine group. Conclusion: Intrathecal dexmedetomidine produces prolonged motor and sensory blockade without undesirable side effects but intraoperative hypotension was more frequent in dexmedetomidine group. PMID:27330198

  13. A prospective, randomized, multicentre trial for the treatment of refractory status epilepticus; experiences from evaluating the effect of the novel drug candidate, NS1209.

    PubMed

    Sabers, Anne; Wolf, Peter; Møller, Arne; Rysgaard, Karen; Ben-Menachem, Elinor

    2013-09-01

    Refractory status epilepticus (RSE) is a life-threatening condition that requires immediate and aggressive treatment. Unfortunately, sometimes standard antiepileptic treatment is insufficient. Furthermore, alternative therapeutic options are limited by low evidence of efficacy. The primary objective of this study was to evaluate the effects of the novel drug candidate, NS1209 versus third-line standard treatment (phenytoin/valproate) for RSE. Having not reached the study end-points, the purpose of this paper is to discuss the challenges that are encountered in conducting a controlled study of RSE. This was a phase II, prospective, multicentre, single-blinded, randomized clinical trial and included patients to two separate protocols for convulsive and non-convulsive RSE (NS1209-006 and NS1209-007). In total, 28 patients were included and 14 patients were exposed to NS1209. At study conclusion, the study was insufficiently powered to detect any statistically significant difference between the two treatment groups. This was especially true for the convulsive RSE protocol. We conclude that high-quality studies in RSE are difficult to conduct owing to a number of ethical and practical problems associated with this critical illness. Challenges for further studies are discussed.

  14. Comparison of the Efficacy of the Embolic Agents Acrylamido Polyvinyl Alcohol Microspheres and Tris-Acryl Gelatin Microspheres for Uterine Artery Embolization for Leiomyomas: A Prospective Randomized Controlled Trial

    SciTech Connect

    Worthington-Kirsch, Robert L.; Chesnick, Richard

    2011-06-15

    Objective: To evaluate the efficacy of acrylamido polyvinyl alcohol microspheres (a-PVAM) as an embolic agent for uterine artery embolization (UAE) compared with Tris-acryl gelatin microspheres (TAGM).Design, Setting, ParticipantsProspective randomized double-blind noninferiority trial. Conducted at two sites both with regional UAE practices. Forty-six women with symptomatic leiomyomas.InterventionUAE procedure was performed with either of the two embolic agents. Either 700-900-{mu}m a-PVAM or 500-700-{mu}m TAGM was used.Main Outcome MeasuresChanges in leiomyoma perfusion, overall uterine volume, and dominant leiomyomas volume measured by contrast-enhanced magnetic resonance imaging at 1 week, 3 months, and 6 months after UAE by a reader blinded to the embolic agent used. Changes in Uterine Fibroid Symptoms and Quality of Life questionnaire scores were measured at 3, 6, and 12 months after UAE. Results: Forty-six patients were randomized and treated under the study protocol (a-PVAM n = 22, TAGM n = 24). There were no procedure-related complications. Two patients were excluded from analysis (one technical failure of the procedure, one withdrawal from study). Successful (>90%) leiomyoma devascularization was observed in 81% of subjects at 1 week after UAE, 97% at 3 months after UAE, and 95% at 6 months after UAE. No significant differences were observed in 14 of 15 outcome measurements, consistent with noninferiority. TAGM was slightly superior to a-PVAM on one comparison (overall quality of life at 3 months after UAE).

  15. Investigation of the clinical efficacy of 0.2% topical stannous fluoride for the treatment of canine superficial pyoderma: a prospective, randomized, double-blinded, placebo-controlled trial.

    PubMed

    Seltzer, Judith D; Flynn-Lurie, Alison K; Marsella, Rosanna; Brennan, Meghan M

    2010-06-01

    Stannous fluoride (SF) is an antibacterial compound that has been successfully used to treat gingivitis in people and dogs, and cutaneous bacterial infections in horses. The purpose of this prospective, double-blinded, placebo-controlled clinical trial was to investigate the efficacy of 0.2% SF spray (BacDerm; Emerald 3 Enterprises Inc., Camdenton, MO, USA) for the treatment of canine superficial pyoderma. Twenty-six privately owned dogs with bacterial skin infections diagnosed on clinical signs, cytology and aerobic culture were enrolled. Dogs were randomly assigned to vehicle only or active ingredient treatment groups. The product was applied topically to affected areas once daily for 28 days, with assessments at days 0, 14, 28 and 42. Clinical and cytological evaluations were performed by the same investigators at each visit. Owners scored the improvement of hair coat, odour, pruritus and overall improvement at each recheck. Linear mixed models showed significant effects of treatment (P < 0.0001) and time (P = 0.0037) for investigator's scores, and a significant time effect for owners' haircoat (P = 0.0077) and odour (P = 0.0170) improvement scores. Dogs in both placebo and SF groups showed some improvement over time, and the investigator's scores on days 0 and 28 were not significantly different between groups for both (t-test P > 0.05). Spearman's rho correlation coefficients revealed a significant negative correlation between investigator's scores and all categories of owners' assessment scores in dogs of both groups. Although some dogs improved on SF, this study does not support the use of 0.2% SF as sole therapy for canine superficial pyoderma.

  16. Efficacy, safety and pharmacokinetic of once-daily boosted saquinavir (1500/100 mg) together with 2 nucleos(t)ide reverse transcriptase inhibitors in real life: a multicentre prospective study

    PubMed Central

    2010-01-01

    Background Ritonavir-boosted saquinavir (SQVr) is nowadays regarded as an alternative antiretroviral drug probably due to several drawbacks, such as its high pill burden, twice daily dosing and the requirement of 200 mg ritonavir when given at the current standard 1000/100 mg bid dosing. Several once-daily SQVr dosing schemes have been studied with the 200 mg SQV old formulations, trying to overcome some of these disadvantages. SQV 500 mg strength tablets became available at the end of 2005, thus facilitating a once-daily regimen with fewer pills, although there is very limited experience with this formulation yet. Methods Prospective, multicentre study in which efficacy, safety and pharmacokinetics of a regimen of once-daily SQVr 1500/100 mg plus 2 NRTIs were evaluated under routine clinical care conditions in either antiretroviral-naïve patients or in those with no previous history of antiretroviral treatments and/or genotypic resistance tests suggesting SQV resistance. Plasma SQV trough levels were measured by HPLV-UV. Results Five hundred and fourteen caucasian patients were included (47.2% coinfected with hepatitis C and/or B virus; 7.8% with cirrhosis). Efficacy at 52 weeks (plasma RNA-HIV <50 copies/ml) was 67.7% (CI95: 63.6 - 71.7%) by intention-to-treat, and 92.2% (CI95: 89.8 - 94.6%) by on-treatment analysis. The reasons for failure were: dropout or loss to follow-up (18.4%), virological failure (7.8%), adverse events (3.1%), and other reasons (4.6%). The high rate of dropout may be explained by an enrollement and follow-up under routine clinical care condition, and a population with a significant number of drug users. The median SQV Cmin (n = 49) was 295 ng/ml (range, 53-2172). The only variable associated with virological failure in the multivariate analysis was adherence (OR: 3.36; CI95, 1.51-7.46, p = 0.003). Conclusions Our results suggests that SQVr (1500/100 mg) once-daily plus 2 NRTIs is an effective regimen, without severe clinical adverse

  17. Efficacy and safety of thalidomide for the treatment of severe recurrent epistaxis in hereditary hemorrhagic telangiectasia: results of a prospective phase II clinical trial

    PubMed Central

    Invernizzi, Rosangela; Quaglia, Federica; Klersy, Caherine; Pagella, Fabio; Ornati, Federica; Chu, Francesco; Matti, Elina; Spinozzi, Giuseppe; Plumitallo, Sara; Grignani, Pierangela; Olivieri, Carla; Bastia, Raffaella; Bellistri, Francesca; Danesino, Cesare; Benazzo, Marco; Balduini, Carlo L

    2016-01-01

    Summary Background Hereditary hemorrhagic telangiectasia (HHT) is a genetic disease that leads to multiregional angiodysplasia. Severe recurrent epistaxis is the most common presentation, frequently leading to severe anemia. Multiple therapeutic approaches have been tried, but they are largely palliative with variable results.We aimed to assess the efficacy of thalidomide in reducing epistaxis in patients with HHT refractory to standard therapy. Methods HHT patients with severe recurrent epistaxis refractory to mini-invasive surgical procedures were included in an open label, phase II, prospective, non-randomized, single-centre study. Thalidomide was administered at a starting dose of 50 mg/day orally. In the event of no response, thalidomide dosage was increased by 50 mg/day every four weeks until response to a maximum dose of 200 mg/day. After response achievement, patients were treated for eight to16 additional weeks. Monthly follow-up was based on the epistaxis severity score and transfusion need, with adverse events being reported (ClinicalTrials.gov Identifier: NCT01485224). Findings Thirty-one patients, mean age 62∙6 (SD 11∙1) years, were enrolled (median follow-up 15∙9 months, 25th-75th 10∙1-22∙3). Treatment induced cessation of bleeding in three cases (9∙7%) and a significant decrease in all epistaxis parameters in 28 cases (90∙3%). Twenty-five patients (80∙7%) obtained remission with 50 mg/day of thalidomide, five (16∙1%) with 100 mg/day and one (3∙2%) with 150 mg/day. Treatment significantly increased hemoglobin levels (p<0∙001), and abolished or greatly decreased the transfusion need (p<0∙001).Only nonserious, grade I, adverse effects were observed, including constipation and drowsiness. Median time to relapse after the end of therapy was 6∙4 months. No correlation was found between genetic or clinical features and response to thalidomide or toxicity. Interpretation Low-dose thalidomide is safe and very effective in reducing

  18. Infliximab therapy for intestinal, neurological, and vascular involvement in Behcet disease: Efficacy, safety, and pharmacokinetics in a multicenter, prospective, open-label, single-arm phase 3 study.

    PubMed

    Hibi, Toshifumi; Hirohata, Shunsei; Kikuchi, Hirotoshi; Tateishi, Ukihide; Sato, Noriko; Ozaki, Kunihiko; Kondo, Kazuoki; Ishigatsubo, Yoshiaki

    2016-06-01

    Behçet disease (BD) is a multisystem disease associated with a poor prognosis in cases of gastrointestinal, neurological, or vascular involvement. We conducted a multicenter, prospective, open-label, single-arm phase 3 study to determine the efficacy, safety, and pharmacokinetics of infliximab (IFX) in BD patients with these serious complications who had displayed poor response or intolerance to conventional therapy.IFX at 5 mg/kg was administered to 18 patients (11 intestinal BD, 3 neurological BD [NBD], and 4 vascular BD [VBD]) at weeks 0, 2, and 6 and every 8 weeks thereafter until week 46. In patients who showed inadequate responses to IFX after week 30, the dose was increased to 10 mg/kg. We then calculated the percentage of complete responders according to the predefined criteria depending on the symptoms and results of examinations (ileocolonoscopy, brain magnetic resonance imaging, computed tomography angiography, positron emission tomography, cerebrospinal fluid, or serum inflammatory markers), exploring the percentage of complete responders at week 30 (primary endpoint).The percentage of complete responders was 61% (11/18) at both weeks 14 and 30 and remained the same until week 54. Intestinal BD patients showed improvement in clinical symptoms along with decrease in C-reactive protein (CRP) levels after week 2. Consistently, scarring or healing of the principal ulcers was found in more than 80% of these patients after week 14. NBD patients showed improvement in clinical symptoms, imaging findings, and cerebrospinal fluid examinations. VBD patients showed improvement in clinical symptoms after week 2 with reductions in CRP levels and erythrocyte sedimentation rate. Imaging findings showed reversal of inflammatory changes in 3 of the 4 VBD patients. Irrespective of the type of BD, all patients achieved improvement in quality of life, leading to the dose reduction or withdrawal of steroids. IFX dose was increased to 10 mg/kg in 3 intestinal BD

  19. Infliximab therapy for intestinal, neurological, and vascular involvement in Behcet disease: Efficacy, safety, and pharmacokinetics in a multicenter, prospective, open-label, single-arm phase 3 study

    PubMed Central

    Hibi, Toshifumi; Hirohata, Shunsei; Kikuchi, Hirotoshi; Tateishi, Ukihide; Sato, Noriko; Ozaki, Kunihiko; Kondo, Kazuoki; Ishigatsubo, Yoshiaki

    2016-01-01

    Abstract Behçet disease (BD) is a multisystem disease associated with a poor prognosis in cases of gastrointestinal, neurological, or vascular involvement. We conducted a multicenter, prospective, open-label, single-arm phase 3 study to determine the efficacy, safety, and pharmacokinetics of infliximab (IFX) in BD patients with these serious complications who had displayed poor response or intolerance to conventional therapy. IFX at 5 mg/kg was administered to 18 patients (11 intestinal BD, 3 neurological BD [NBD], and 4 vascular BD [VBD]) at weeks 0, 2, and 6 and every 8 weeks thereafter until week 46. In patients who showed inadequate responses to IFX after week 30, the dose was increased to 10 mg/kg. We then calculated the percentage of complete responders according to the predefined criteria depending on the symptoms and results of examinations (ileocolonoscopy, brain magnetic resonance imaging, computed tomography angiography, positron emission tomography, cerebrospinal fluid, or serum inflammatory markers), exploring the percentage of complete responders at week 30 (primary endpoint). The percentage of complete responders was 61% (11/18) at both weeks 14 and 30 and remained the same until week 54. Intestinal BD patients showed improvement in clinical symptoms along with decrease in C-reactive protein (CRP) levels after week 2. Consistently, scarring or healing of the principal ulcers was found in more than 80% of these patients after week 14. NBD patients showed improvement in clinical symptoms, imaging findings, and cerebrospinal fluid examinations. VBD patients showed improvement in clinical symptoms after week 2 with reductions in CRP levels and erythrocyte sedimentation rate. Imaging findings showed reversal of inflammatory changes in 3 of the 4 VBD patients. Irrespective of the type of BD, all patients achieved improvement in quality of life, leading to the dose reduction or withdrawal of steroids. IFX dose was increased to 10 mg/kg in 3

  20. A Prospective Phase 2 Multicenter Study for the Efficacy of Radiation Therapy Following Incomplete Transarterial Chemoembolization in Unresectable Hepatocellular Carcinoma

    SciTech Connect

    Choi, Chihwan; Koom, Woong Sub; Kim, Tae Hyun; Yoon, Sang Min; Kim, Jin Hee; Lee, Hyung-Sik; Nam, Taek-Keun; Seong, Jinsil

    2014-12-01

    Purpose: The purpose of this study was to investigate the efficacy and toxicity of radiation therapy (RT) following incomplete transarterial chemoembolization (TACE) in unresectable hepatocellular carcinoma (HCC). Methods and Materials: The study was designed as a prospective phase 2 multicenter trial. Patients with unresectable HCC, who had viable tumor after TACE of no more than 3 courses, were eligible. Three-dimensional conformal RT (3D-CRT) was added for HCC treatment with incomplete uptake of iodized oil, and the interval from TACE to RT was 4 to 6 weeks. The primary endpoint of this study was the tumor response after RT following incomplete TACE in unresectable HCC. Secondary endpoints were patterns of failure, progression-free survival (PFS), time to tumor progression (TTP), overall survival (OS) rates at 2 years, and treatment-associated toxicity. Survival was calculated from the start of RT. Results: Between August 2008 and December 2010, 31 patients were enrolled. RT was delivered at a median dose of 54 Gy (range, 46-59.4 Gy) at 1.8 to 2 Gy per fraction. A best objective in-field response rate was achieved in 83.9% of patients, with complete response (CR) in 22.6% of patients and partial response in 61.3% of patients within 12 weeks post-RT. A best objective overall response rate was achieved in 64.5% of patients with CR in 19.4% of patients and PR in 45.1% of patients. The 2-year in-field PFS, PFS, TTP, and OS rates were 45.2%, 29.0%, 36.6%, and 61.3%, respectively. The Barcelona Clinic liver cancer stage was a significant independent prognostic factor for PFS (P=.023). Classic radiation-induced liver disease was not observed. There were no treatment-related deaths or hepatic failure. Conclusions: Early 3D-CRT following incomplete TACE is a safe and practical treatment option for patients with unresectable HCC.

  1. Efficacy and Safety of a Hyaluronic Acid Filler to Correct Aesthetically Detracting or Deficient Features of the Asian Nose: A Prospective, Open-Label, Long-Term Study

    PubMed Central

    Liew, Steven; Scamp, Terrence; de Maio, Mauricio; Halstead, Michael; Johnston, Nicole; Silberberg, Michael; Rogers, John D.

    2016-01-01

    Background There is increasing interest among patients and plastic surgeons for alternatives to rhinoplasty, a common surgical procedure performed in Asia. Objectives To evaluate the safety, efficacy, and longevity of a hyaluronic acid filler in the correction of aesthetically detracting or deficient features of the Asian nose. Methods Twenty-nine carefully screened Asian patients had their noses corrected with the study filler (Juvéderm VOLUMA [Allergan plc, Dublin, Ireland] with lidocaine injectable gel), reflecting individualized treatment goals and utilizing a standardized injection procedure, and were followed for over 12 months. Results A clinically meaningful correction (≥1 grade improvement on the Assessment of Aesthetic Improvement Scale) was achieved in 27 (93.1%) patients at the first follow-up visit. This was maintained in 28 (96.6%) patients at the final visit, based on the independent assessments of a central non-injecting physician and the patients. At this final visit, 23 (79.3%) patients were satisfied or very satisfied with the study filler and 25 (86.2%) would recommend it to others. In this small series of patients, there were no serious adverse events (AEs), with all treatment-related AEs being mild to moderate, transient injection site reactions, unrelated to the study filler. Conclusions Using specific eligibility criteria, individualized treatment goals, and a standardized injection procedure, the study filler corrected aesthetically detracting or deficient features of the Asian nose, with the therapeutic effects lasting for over 12 months, consistent with a high degree of patient satisfaction. This study supports the safety and efficacy of this HA filler for specific nose augmentation procedures in selected Asian patients. Level of Evidence: 3 Therapeutic PMID:27301371

  2. Efficacy of Sucralfate Mouth Wash in Prevention of 5-fluorouracil Induced Oral Mucositis: A Prospective, Randomized, Double-Blind, Controlled Trial.

    PubMed

    Ala, Shahram; Saeedi, Majid; Janbabai, Ghasem; Ganji, Reza; Azhdari, Elham; Shiva, Afshin

    2016-01-01

    Sucralfate has been used for the prevention and treatment of radiotherapy- and chemotherapy-induced stomatitis and mucositis in a number of studies, but the results are contradictory. To answer such discrepancies, the present study was designed to evaluate the efficacy of sucralfate mouthwash in prevention of 5-fluorouracil (5-FU)-induced oral mucositis in patients with gastrointestinal malignancies. Patients with gastrointestinal cancers receiving 5-FU-based chemotherapy regimens were included in this randomized, blinded, controlled trial and were randomly allocated to either sucralfate mouthwash (every 6 h) or placebo. The patients were visited at fifth and tenth day of trial; the presence and severity of oral mucositis and the intensity of pain were assessed. The patients receiving sucralfate experienced lower frequency and severity of mucositis (76% vs. 38.5%, P = 0.005 and 84 vs. 38.5%, P < 0.001, respectively) and less intense pain (2.5 ± 2.2 vs. 5.08 ± 3.82, P = 0.004 and 1.33 ± 0.86 vs. 4.12 ± 3.5, P = 0.001, respectively) compared with the placebo group both at day 5 and day 10. Within the sucralfate group, a decrease in frequency and severity of mucositis was observed throughout the trial period, while in the placebo group no such effect was observed. Sucralfate mouthwash reduced the frequency and severity of 5-FU-induced oral mucositis in patients with gastrointestinal malignancies compared with placebo, indicating its efficacy in the prevention of chemotherapy-induced mucositis.

  3. A Psychometric Evaluation of the Career Decision Self-Efficacy Scale with Korean Students: A Rasch Model Approach

    ERIC Educational Resources Information Center

    Nam, Suk Kyung; Yang, Eunjoo; Lee, Sang Min; Lee, Sang Hee; Seol, Hyunsoo

    2011-01-01

    The Career Decision Self-Efficacy Scale (CDSE) is one of the most frequently used in the field of career development and counseling. In this study, using the Rasch rating scale model analysis, the CDSE Scale was evaluated by the content, structural, and substantive aspects of validity in a sample of college students from South Korea. Overall, the…

  4. Latent Profiles of Parental Self-Efficacy and Children's Multisource-Evaluated Social Competence

    ERIC Educational Resources Information Center

    Junttila, Niina; Vauras, Marja

    2014-01-01

    Background: The interrelation between mothers' parental self-efficacy (PSE) and their school-aged children's well-being has been repeatedly proved. The lack of research in this area situates mainly on the absence of fathers, non-existent family-level studies, the paucity of independent evaluators, and the use of global PSE estimates.…

  5. Do Children Prefer Contingencies? An Evaluation of the Efficacy of and Preference for Contingent versus Noncontingent Social Reinforcement during Play

    ERIC Educational Resources Information Center

    Luczynski, Kevin C.; Hanley, Gregory P.

    2009-01-01

    Discovering whether children prefer reinforcement via a contingency or independent of their behavior is important considering the ubiquity of these programmed schedules of reinforcement. The current study evaluated the efficacy of and preference for social interaction within differential reinforcement of alternative behavior (DRA) and…

  6. Understanding Acid-Base Concepts: Evaluating the Efficacy of a Senior High School Student-Centred Instructional Program in Indonesia

    ERIC Educational Resources Information Center

    Rahayu, Sri; Chandrasegaran, A. L.; Treagust, David F.; Kita, Masakazu; Ibnu, Suhadi

    2011-01-01

    This study was a mixed quantitative-qualitative research to evaluate the efficacy of a designed student-centred instructional (DSCI) program for teaching about acids and bases. The teaching innovation was designed based on constructivist, hands-on inquiry and context-based approaches and implemented in seven 45-min lessons with a class of 36 grade…

  7. EVALUATION OF THE EFFICACY OF EXTRAPOLATION POPULATION MODELING TO PREDICT THE DYNAMICS OF AMERICAMYSIS BAHIA POPULATIONS IN THE LABORATORY

    EPA Science Inventory

    An age-classified projection matrix model has been developed to extrapolate the chronic (28-35d) demographic responses of Americamysis bahia (formerly Mysidopsis bahia) to population-level response. This study was conducted to evaluate the efficacy of this model for predicting t...

  8. The development of new oximes and the evaluation of their reactivating, therapeutic and neuroprotective efficacy against tabun.

    PubMed

    Kassa, Jiri; Kuca, Kamil; Karasova, Jana; Musilek, Kamil

    2008-10-01

    Tabun (O-ethyl-N,N-dimethyl phosphoramidocyanidate) belongs to highly toxic organophosphorus compounds misused as chemical warfare agents for military as well as terroristic purposes. The antidotal treatment of tabun acute poisonings still represents a serious problem and the development of new, more effective AChE reactivators to achieve the satisfactorily effective antidotal treatment of acute poisonings with tabun still represents very important goal. Since 2003, we have prepared around 200 new AChE reactivators. Their potency to reactivate tabun-inhibited acetylcholinesterase has been subsequently evaluated using our in vitro screening test. Afterwards, promising compounds were selected and kinetic parameters and reactivation constants were determined. Then, the best reactivators were subjected to the in vivo studies (toxicity test, the evaluation of therapeutic, reactivating and neuroprotective efficacy) and their potency to counteract the acute toxicity of tabun is compared to the therapeutic, reactivating and neuroprotective efficacy of commonly used oximes - obidoxime and the oxime HI-6. According to the results obtained, the newly synthesized oxime K075 showed the highest potency to reduce tabun-induced acute lethal toxicity while the therapeutic potency of obidoxime and the oxime HI-6 was significantly lower. The therapeutic efficacy of oximes studied corresponds to their reactivating efficacy in vivo as well as in vitro. The potency of all newly synthesized oximes to reactivate tabun-inhibited AChE is comparable with obidoxime with the exception of K074 that is significantly more efficacious in the brain. In addition, all newly synthesized oximes combined with atropine seem to be effective antidotes for a decrease in tabun-induced acute neurotoxicity. While the neuroprotective efficacy of obidoxime in combination with atropine is similar to the potency of newly synthesized oximes, the ability of the oxime HI-6 combined with atropine to counteract tabun

  9. Evaluation of the Location and Recency of Faulting Near Prospective Surface Facilities in Midway Valley, Nye County, Nevada

    USGS Publications Warehouse

    Swan, F.H.; Wesling, J.R.; Angell, M.M.; Thomas, A.P.; Whitney, J.W.; Gibson, J.D.

    2001-01-01

    Evaluation of surface faulting that may pose a hazard to prospective surface facilities is an important element of the tectonic studies for the potential Yucca Mountain high-level radioactive waste repository in southwestern Nevada. For this purpose, a program of detailed geologic mapping and trenching was done to obtain surface and near-surface geologic data that are essential for determining the location and recency of faults at a prospective surface-facilities site located east of Exile Hill in Midway Valley, near the eastern base of Yucca Mountain. The dominant tectonic features in the Midway Valley area are the north- to northeast-trending, west-dipping normal faults that bound the Midway Valley structural block-the Bow Ridge fault on the west side of Exile Hill and the Paint-brush Canyon fault on the east side of the valley. Trenching of Quaternary sediments has exposed evidence of displacements, which demonstrate that these block-bounding faults repeatedly ruptured the surface during the middle to late Quaternary. Geologic mapping, subsurface borehole and geophysical data, and the results of trenching activities indicate the presence of north- to northeast-trending faults and northwest-trending faults in Tertiary volcanic rocks beneath alluvial and colluvial sediments near the prospective surface-facilities site. North to northeast-trending faults include the Exile Hill fault along the eastern base of Exile Hill and faults to the east beneath the surficial deposits of Midway Valley. These faults have no geomorphic expression, but two north- to northeast-trending zones of fractures exposed in excavated profiles of middle to late Pleistocene deposits at the prospective surface-facilities site appear to be associated with these faults. Northwest-trending faults include the West Portal and East Portal faults, but no disruption of Quaternary deposits by these faults is evident. The western zone of fractures is associated with the Exile Hill fault. The eastern

  10. Evaluation of the location and recency of faulting near prospective surface facilities in Midway Valley, Nye County, Nevada

    SciTech Connect

    Swan, F.H.; Wesling, J.R.; Angell, M.M.; Thomas, A.P.; Whitney, J.W.; Gibson, J.D.

    2002-01-17

    Evaluation of surface faulting that may pose a hazard to prospective surface facilities is an important element of the tectonic studies for the potential Yucca Mountain high-level radioactive waste repository in southwestern Nevada. For this purpose, a program of detailed geologic mapping and trenching was done to obtain surface and near-surface geologic data that are essential for determining the location and recency of faults at a prospective surface-facilities site located east of Exile Hill in Midway Valley, near the eastern base of Yucca Mountain. The dominant tectonic features in the Midway Valley area are the north- to northeast-trending, west-dipping normal faults that bound the Midway Valley structural block-the Bow Ridge fault on the west side of Exile Hill and the Paint-brush Canyon fault on the east side of the valley. Trenching of Quaternary sediments has exposed evidence of displacements, which demonstrate that these block-bounding faults repeatedly ruptured the surface during the middle to late Quaternary. Geologic mapping, subsurface borehole and geophysical data, and the results of trenching activities indicate the presence of north- to northeast-trending faults and northwest-trending faults in Tertiary volcanic rocks beneath alluvial and colluvial sediments near the prospective surface-facilities site. North to northeast-trending faults include the Exile Hill fault along the eastern base of Exile Hill and faults to the east beneath the surficial deposits of Midway Valley. These faults have no geomorphic expression, but two north- to northeast-trending zones of fractures exposed in excavated profiles of middle to late Pleistocene deposits at the prospective surface-facilities site appear to be associated with these faults. Northwest-trending faults include the West Portal and East Portal faults, but no disruption of Quaternary deposits by these faults is evident. The western zone of fractures is associated with the Exile Hill fault. The eastern

  11. [Efficacy of zuclopenthixol acetate on psychotic anxiety evaluated in an open study].

    PubMed

    Romain, J L; Dermain, P; Greslé, P; Grignon, S; Moisan, P; Nore, D; Pech, G; Benyaya, J; Perret, I

    1996-01-01

    The first scale evaluating psychotic anxiety specifically is the "Psychotic Anxiety Scale": PAS was proposed and validated by O. Blin et al. in 1988. Zuclopenthixol acetate formulation is a both rapid and middle prolonged (2-3 days) acting neuroleptic used to start the treatment in an acute episode of the psychotic illness. It has been established as an effective drug for a broad spectrum of symptoms in schizophrenia and other psychosis, but its "angolytic" effect had never been quantified. It was interesting to study the efficacy of zuclopenthixol acetate on psychotic anxiety with PAS during the first 9 days of hospitalisation of psychotic patients. During the study, the clinical evaluation was made with the Psychotic Anxiety Scale (PAS) for the main criteria; Clinical Global Impression (CGI) and the Nordic side effect scale (UKU) for the secondary criteria. Assessments were performed at days, 0, 1, 3, 4, 6, 7 and 9. Zuclopenthixol acetate was administered at Day 0, Day 3, and Day 6. Protocol allowed an additional injection at D1 in case of insufficient efficacy. Forty six patients were included into this open non comparative multicenter study: 23 patients were male and 23 female. Their mean age (X +/- S) was 32 +/- 10 years, and according to DSM III-R, 28 of them got schizophrenia diagnosis, 13 suffered from brief psychotic disorder and 3 from schizophreniform disorder (diagnosis was missing for two subjects). The mean dosage of zuclopenthixol acetate by injection, foreseen in the protocol, was between 126 to 138 mg. Four patients were treated with high dose: more than 800 mg during the 9 days of the study and 6 patients had 5 injections or more. Between D0 and D9, the total PAS score decreased from 63 (from moderated to severe anxiety) to 25 (absence of anxiety) and the reduction of score was statistically significant from 24 hours after the first injection (p < 0.01). Various items analysis of PAS has showed a statistically significant reduction from 24 hours

  12. Planning for a smooth transition: evaluation of a succession planning program for prospective nurse unit managers.

    PubMed

    Manning, Vicki; Jones, Alan; Jones, Pamela; Fernandez, Ritin S

    2015-01-01

    The current and projected nurse workforce shortage has created significant pressure on health care organizations to examine their approach to managing talent. This includes the need for strategic development of new formal leaders. This article reports on a succession planning program for prospective nursing unit managers. Eight prospective management candidates participated in a Future Nursing Unit Managers program. The effectiveness of the program was measured through a comparison of pre- and postprogram surveys relating to participants' perception of personal managerial and leadership skills. Significant differences in scores from baseline to 6-month follow-up surveys were observed in the participants' confidence in undertaking the nursing unit manager role and in their management skills. Investment in structured programs to prepare nurses for leadership roles is strongly recommended as a management workforce strategy.

  13. Ethical problems with the mental health evaluation standards of care for adult gender variant prospective patients.

    PubMed

    Hale, C Jabob

    2007-01-01

    The World Professional Association for Transgender Health's "Standards of Care: The Hormonal and Surgical Sex Reassignment of Gender Dysphoric Persons" (SOC) set forth standards clinicians must meet to ensure ethical care of adequate quality. The SOC also set requirements gender variant prospective patients must meet to receive medical interventions to change their sexual characteristics to those more typical for the sex to which they were not assigned at birth. One such requirement is that mental health professionals must ascertain that prospective patients have met the SOC's eligibility and readiness criteria. This article raises two objections to this requirement: ethically obligatory considerations of the overall balance of potential harms and benefits tell against it, and it violates the principle of respect for autonomy. This requirement treats gender variant prospective patients who request medical intervention as different in kind, not merely degree, from other patient populations, as it constructs the very request as a phenomenon of incapacity. This is ethically indefensible in and of itself, but it is especially pernicious in a sociocultural and political context that already denies gender variant people full moral status.

  14. Efficacy of botulinum toxin type B for the treatment of primary palmar hyperhidrosis: a prospective, open, single-blind, multi-centre study.

    PubMed

    Basciani, Mario; Di Rienzo, Filomena; Bizzarrini, Massimo; Zanchi, Malvina; Copetti, Massimiliano; Intiso, Domenico

    2014-07-01

    Primary palmar hyperhidrosis is a distressing and disabling condition that can produce social, psychological and occupational problems. Although the use of botulinum toxin type A (BoNT-A) has been reported as an efficacious and safe intervention to improve palmar hyperhidrosis, only one study concerned botulinum toxin type B (BoNT-B) in this disorder. The aim of study was to evaluate the efficacy and safety of BoNT-B in treating primary palmar hyperhidrosis. Participants were injected with 5,000 IU of BoNT-B in each palm. Visual analogue test (VAS) to evaluate the intensity of decrease in sweat production, Minor's iodine starch test and measurement of paper towels' weight were used to ascertain palmar sweating at baseline, 4, 12 and 24 weeks after BoNT-B injections by a blind examiner. Thirty-two subjects (12 males, 20 females, mean age 31 ± 11) were enrolled. Significant reduction of palmar sweating was detected after BoNT-B injection: 2.9 ± 1.4, 0.3 ± 0.4, 0.9 ± 0.8, and 2.1 ± 1.5 g (p < 0.001) of paper towels' weight for the right palm at baseline, 4, 12 and 24 weeks; and 2.8 ± 1.7, 0.5 ± 0.6, 0.8 ± 0.7, and 1.8 ± 1.25 g (p < 0.001) at same time, respectively for the left palm. Significant reduction of mean VAS values were also detected after BoNT-B injections: 8.6 ± 1.1, 0.6 ± 0.8, 3.5 ± 2.5, and 7.1 ± 2.4 (p < 0.0001) at baseline, 4, 12 and 24 weeks, respectively. Mild side effects consisting in local pain and hand weakness were observed in 4 (12.5%) subjects. The findings indicated that the use of 5,000 IU BoNT-B injection in each palm was safe and significantly improved the severity of palmar hyperhidrosis.

  15. Comparative evaluation of the in vitro efficacy of lanthanum carbonate chewable tablets.

    PubMed

    Yang, Yongsheng; Bykadi, Srikant; Carlin, Alan S; Shah, Rakhi B; Yu, Lawrence X; Khan, Mansoor A

    2013-04-01

    The aims of this study were to systematically evaluate the effects of pH levels, phosphate concentrations, and tablet integrity on the phosphate binding profiles of lanthanum carbonate chewable tablets, and to compare the in vitro phosphate binding efficacy of one reference and two test products of lanthanum carbonate chewable tablets. Langmuir equation was utilized to calculate the binding constants k1 and k2 . The phosphate binding to the tablets of lanthanum carbonate product was pH dependent, with a faster binding rate at low pH. The crushed tablets bind phosphate more rapid. Compared with the whole tablets, the kinetic binding profiles from the crushed tablets were less variable under all conditions for both test and reference products. The phosphate level has a significant impact on the phosphate binding for both whole and crushed tablets under all pH conditions, with more binding at higher phosphate concentration. The phosphate binding profiles displayed significant difference among the products. For a crushed tablet, the phosphate binding to lanthanum reached equilibrium within 8 h under all conditions. The 90% confidence interval for the k2 ratio (test/reference) was well within the 80%-125% under all pH conditions. However, the k1 ratio varies from 54% to 144%. © 2013 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 102:1370-1381, 2013.

  16. Evaluation of the efficacy of paclitaxel with curcumin combination in ovarian cancer cells

    PubMed Central

    Liu, Zeng; Zhu, Yuan-Yuan; Li, Zhao-Yuan; Ning, Si-Qing

    2016-01-01

    The aim of the present study was to evaluate the efficacy of paclitaxel combined with curcumin (CUR) against drug resistance in ovarian cancer cells. PLGA-phospholipid-PEG nanoparticles were prepared using the nano precipitation method. The size and morphology of the nanoparticles were determined using a transmission electron microscope and particle size analyzer. The encapsulation efficiency of nanoparticles was determined using the ultrafiltration centrifugation method. The dialysis method was used to study the release of PLGA-phospholipid-PEG nanoparticles. ADM was used to induce the A2780 cell line (human ovarian cancer cell line) to establish the model of the multidrug-resistant (MDR) cell line, and the protein activity of P-glycoprotein (P-gp) in the A2780 cell line and A2780/ADM resistant cell line was determined using western blot analysis. The results showed that, the prepared nanoparticles were uniform in size, with a size of approximately 100 nm, and round in shape. Additionally, the nanoparticles had a more gentle and slow release than the free drug release. The results of the protein trace printing experiment showed that the P-gp content of the drug-resistant cell line was significantly reduced by the CUR nanoparticles. In conclusion, PLGA-phospholipid nanoparticles containing taxol and CUR have improved solubility and stability together with a slow release effect. In addition, CUR was able to overcome the MDR of tumor cells by elevating the paclitaxel concentration in the tumor cells to improve the antitumor activity of this combination. PMID:27895754

  17. Pharmacokinetic evaluation of a 1,3-dicyclohexylurea nanosuspension formulation to support early efficacy assessment

    NASA Astrophysics Data System (ADS)

    Wahlstrom, Jan L.; Chiang, Po-Chang; Ghosh, Sarbani; Warren, Chad J.; Wene, Steve P.; Albin, Lesley A.; Smith, Mark E.; Roberds, Steven L.

    2007-06-01

    Time and resource constraints necessitate increasingly early decisions to advance or halt pre-clinical drug discovery programs. Early discovery or “tool” compounds may be potent inhibitors of new targets, but all too often they exhibit poor pharmaceutical and pharmacokinetic properties that make early assessment of in vivo efficacy difficult. 1,3-Dicyclohexylurea, a potent and selective inhibitor of soluble epoxide hydrolase (sEH), reduces blood pressure in hypertensive preclinical animal models when administered intraperitoneally using DMSO/corn oil as a delivery vehicle. However, the poor aqueous solubility of DCU poses a challenge for in vivo dosing in a multiple dose situation. Therefore, we developed a nanosuspension formulation of DCU to support oral, intravenous bolus and intravenous infusion dosing. Use of the nanosuspension formulation maintained DCU free plasma levels above the sEH IC50 and demonstrated that the application of formulation technology can accelerate in vivo evaluation of new targets by enabling pharmacodynamic studies of poorly soluble compounds.

  18. Evaluation of physicochemical properties, and antimicrobial efficacy of monoclinic sulfur-nanocolloid

    NASA Astrophysics Data System (ADS)

    Roy Choudhury, Samrat; Mandal, Amrita; Chakravorty, Dipankar; Gopal, Madhuban; Goswami, Arunava

    2013-04-01

    Stable nanocolloids of monoclinic sulfur (β-SNPs) were prepared through `water-in-oil microemulsion technique' at room temperature after suitable modifications of the surface. The morphology (rod shaped; 50 nm in diameter) and allotropic nature (monoclinic) of the SNPs were investigated with Transmission Electron Microscopy and X-ray Diffraction technique. The surface modification, colloidal stability, and surface topology of β-SNPs were evaluated with Fourier Transform Infrared Spectroscopy, zeta potential analysis, and Atomic Force Microscopy. Thermal decomposition pattern of these nanosized particles was determined by Thermo Gravimetric Analysis (TGA). β-SNPs-colloids expressed excellent antimicrobial activities against a series of fungal and bacterial isolates with prominent deformities at their surface. In contrast, insignificant cytotoxicity was achieved against the human derived hepatoma (HepG2) cell line upon treatment with β-SNPs. A simultaneous study was performed to determine the stock concentration of β-SNP-colloids using a novel high phase liquid chromatographic method. Cumulative results of this study hence, elucidate the stabilization of nanosized monoclinic sulfur at room temperature and their potential antimicrobial efficacy over micron-sized sulfur.

  19. Evaluation of disinfectant efficacy against biofilm and suspended bacteria in a laboratory swimming pool model.

    PubMed

    Goeres, D M; Palys, T; Sandel, B B; Geiger, J

    2004-07-01

    Laboratory reactor systems designed to model specific environments enable researchers to explore environmental dynamics in a more controlled manner. This paper describes the design and operation of a reactor system built to model a swimming pool in the laboratory. The model included relevant engineering parameters such as filter loading and turn-overs per day. The water chemistry in the system's bulk water was balanced according to standard recommendations and the system was challenged with a bacterial load and synthetic bather insult, formulated to represent urine and perspiration. The laboratory model was then used to evaluate the efficacy of six chemical treatments against biofilm and planktonic bacteria. Results showed that the biofilm was able to accumulate on coupons and in the filter systems of reactors treated with either 1-3 mg/L free chlorine or 10 mg/L polyhexamethylene biguanide (PHMB). All the treatments tested resulted in at least a 4 log reduction in biofilm density when compared to the control, but shock treatments were the most effective at controlling biofilm accumulation. A once weekly shock dose of 10 mg/L free chlorine resulted in the greatest log reduction in biofilm density. The research demonstrated the importance of studying a biofilm in addition to the planktonic bacteria to assess the microbial dynamics that exist in a swimming pool model.

  20. Murine Model Imitating Chronic Wound Infections for Evaluation of Antimicrobial Photodynamic Therapy Efficacy

    PubMed Central

    Fila, Grzegorz; Kasimova, Kamola; Arenas, Yaxal; Nakonieczna, Joanna; Grinholc, Mariusz; Bielawski, Krzysztof P.; Lilge, Lothar

    2016-01-01

    It is generally acknowledged that the age of antibiotics could come to an end, due to their widespread, and inappropriate use. Particularly for chronic wounds alternatives are being thought. Antimicrobial Photodynamic Therapy (APDT) is a potential candidate, and while approved for some indications, such as periodontitis, chronic sinusitis and other niche indications, its use in chronic wounds is not established. To further facilitate the development of APDT in chronic wounds we present an easy to use animal model exhibiting the key hallmarks of chronic wounds, based on full-thickness skin wounds paired with an optically transparent cover. The moisture-retaining wound exhibited rapid expansion of pathogen colonies up to 8 days while not jeopardizing the host survival. Use of two bioluminescent pathogens; methicillin resistant Staphylococcus aureus (MRSA) and Pseudomonas aeruginosa permits real time monitoring of the pathogens. The murine model was employed to evaluate the performance of four different photosensitizers as mediators in Photodynamic Therapy. While all four photosensitizers, Rose Bengal, porphyrin TMPyP, New Methylene Blue, and TLD1411 demonstrated good to excellent antimicrobial efficacy in planktonic solutions at 1 to 50 μM concentrations, whereas in in vivo the growth delay was limited with 24–48 h delay in pathogen expansion for MRSA, and we noticed longer growth suppression of P. aeruginosa with TLD1411 mediated Photodynamic Therapy. The murine model will enable developing new strategies for enhancement of APDT for chronic wound infections. PMID:27555843

  1. Evaluation of oxime efficacy in nerve agent poisoning: Development of a kinetic-based dynamic model

    SciTech Connect

    Worek, Franz . E-mail: FranzWorek@Bundeswehr.org; Szinicz, Ladislaus; Eyer, Peter; Thiermann, Horst

    2005-12-15

    The widespread use of organophosphorus compounds (OP) as pesticides and the repeated misuse of highly toxic OP as chemical warfare agents (nerve agents) emphasize the necessity for the development of effective medical countermeasures. Standard treatment with atropine and the established acetylcholinesterase (AChE) reactivators, obidoxime and pralidoxime, is considered to be ineffective with certain nerve agents due to low oxime effectiveness. From obvious ethical reasons only animal experiments can be used to evaluate new oximes as nerve agent antidotes. However, the extrapolation of data from animal to humans is hampered by marked species differences. Since reactivation of OP-inhibited AChE is considered to be the main mechanism of action of oximes, human erythrocyte AChE can be exploited to test the efficacy of new oximes. By combining enzyme kinetics (inhibition, reactivation, aging) with OP toxicokinetics and oxime pharmacokinetics a dynamic in vitro model was developed which allows the calculation of AChE activities at different scenarios. This model was validated with data from pesticide-poisoned patients and simulations were performed for intravenous and percutaneous nerve agent exposure and intramuscular oxime treatment using published data. The model presented may serve as a tool for defining effective oxime concentrations and for optimizing oxime treatment. In addition, this model can be useful for the development of meaningful therapeutic animal models.

  2. Performance evaluation of biofil toilet waste digester technologies in Ghana: the efficacy of effluent treatment options.

    PubMed

    Amoah, Philip; Gbenatey Nartey, Eric; Schrecongost, Alyse

    2016-12-01

    The study was carried out to assess the efficacy of a standard Biofil toilet digester with regard to its effluent quality and to evaluate the performance of new effluent polishing options being developed by BiofilCom. Influent and effluent were collected from 18 standard Biofil digesters connected to full-flush toilets. Effluent from five pilot installations with improved effluent polishing options were also taken for analyses. Ten other Biofil installations were selected to assess the impact of digester effluent discharge on the surrounding soil. Pollutant concentrations in the Biofil effluent exceeded both Ghana EPA and WHO standards for discharge though pollutant removal efficiencies were high: 84% for biochemical oxygen demand, 86.1% for chemical oxygen demand and 82.4% for total suspended solids. Escherichia coli and total coliform levels were significantly reduced by 63% and 95.6%, respectively, and nutrients were the least removed from effluents. Generally, effluents from the majority of the pilot polishing options met most of the discharge standards. E. coli were present in the soil at all study sites, except one. Biofil digester effluent is discharged subsurface but comparing their effluent quality with standards for discharge into water courses is relevant especially in areas of frequent flooding and high water tables.

  3. Cognitive and physical training for the elderly: evaluating outcome efficacy by means of neurophysiological synchronization.

    PubMed

    Frantzidis, Christos A; Ladas, Aristea-Kiriaki I; Vivas, Ana B; Tsolaki, Magda; Bamidis, Panagiotis D

    2014-07-01

    Recent neuroscientific research has demonstrated that both healthy and pathological aging induces alterations in the co-operative capacity of neuronal populations in the brain. Both compensatory and neurodegenerative mechanisms contribute to neurophysiological synchronization patterns, which provide a valuable marker for age-related cognitive decline. In this study, we propose that neuroplasticity-based training may facilitate coherent interaction of distant brain regions and consequently enhance cognitive performance in elderly people. If this is true, this would make neurophysiological synchronization a valid outcome measure to assess the efficacy of non-pharmacological interventions to prevent or delay age-related cognitive decline. The present study aims at providing an objective, synchronization-based tool to assess cognitive and/or physical interventions, adopting the notion of Relative Wavelet Entropy. This mathematical model employs a robust and parameter-free synchronization metric. By using data mining techniques, a distance value was computed for all participants so as to quantify the proximity of their individual profile to the mean group synchronization increase. In support of our hypothesis, results showed a significant increase in synchronization, for four electrode pairs, in the intervention group as compared to the active control group. It is concluded that the novel introduction of neurophysiological synchronization features could be used as a valid and reliable outcome measure; while the distance-based analysis could provide a reliable means of evaluating individual benefits.

  4. Re-evaluation the immune efficacy of Newcastle disease virus vaccine in commercial laying chickens.

    PubMed

    Han, Qingsong; Gao, Xiaolong; Wu, Pengpeng; Xiao, Sa; Wang, Xinglong; Liu, Peng; Tong, Lina; Hao, Huafang; Zhang, Shuxia; Dang, Ruyi; Yang, Zengqi

    2017-04-01

    Newcastle disease virus (NDV) infection causes serious problems in laying chickens, like reducing egg production, increasing rate of abnormal eggs in spite of strict vaccination in layer farms program. A new evaluation system is needed to show complete protection of the immunization in laying chickens based on the egg-laying performance, rather than clinical signs of the disease. In this study, laying chickens with different anti-NDV HI (hemagglutination-inhibition) antibody titer after vaccination were divided into different groups. These chickens were then challenged with field isolated highly virulent NDV strains. Results showed that the chickens in low HI titers group (5log2 to 8log2) and medium HI titers group (9log2 to 11log2) had atypical symptoms, produced abnormal eggs, and shed virus. Whereas, with HI titers≥12log2, the chickens were completely protected, and did not show symptoms, or produce abnormal eggs or shed virus. Morbidity, positive viral shedding rate and abnormal egg-rate decreased with increase in pre-challenge HI antibody titer. Our result suggested that 12log2 is the threshold of the HI antibody in providing complete protection to laying chickens under field condition, and protective efficacy is correlated with HI antibody titer. This study provides a valuable reference for the vaccination and control of ND in poultry.

  5. Evaluation of the efficacy and safety of rivaroxaban using a computer model for blood coagulation.

    PubMed

    Burghaus, Rolf; Coboeken, Katrin; Gaub, Thomas; Kuepfer, Lars; Sensse, Anke; Siegmund, Hans-Ulrich; Weiss, Wolfgang; Mueck, Wolfgang; Lippert, Joerg

    2011-04-22

    Rivaroxaban is an oral, direct Factor Xa inhibitor approved in the European Union and several other countries for the prevention of venous thromboembolism in adult patients undergoing elective hip or knee replacement surgery and is in advanced clinical development for the treatment of thromboembolic disorders. Its mechanism of action is antithrombin independent and differs from that of other anticoagulants, such as warfarin (a vitamin K antagonist), enoxaparin (an indirect thrombin/Factor Xa inhibitor) and dabigatran (a direct thrombin inhibitor). A blood coagulation computer model has been developed, based on several published models and preclinical and clinical data. Unlike previous models, the current model takes into account both the intrinsic and extrinsic pathways of the coagulation cascade, and possesses some unique features, including a blood flow component and a portfolio of drug action mechanisms. This study aimed to use the model to compare the mechanism of action of rivaroxaban with that of warfarin, and to evaluate the efficacy and safety of different rivaroxaban doses with other anticoagulants included in the model. Rather than reproducing known standard clinical measurements, such as the prothrombin time and activated partial thromboplastin time clotting tests, the anticoagulant benchmarking was based on a simulation of physiologically plausible clotting scenarios. Compared with warfarin, rivaroxaban showed a favourable sensitivity for tissue factor concentration inducing clotting, and a steep concentration-effect relationship, rapidly flattening towards higher inhibitor concentrations, both suggesting a broad therapeutic window. The predicted dosing window is highly accordant with the final dose recommendation based upon extensive clinical studies.

  6. Flea-borne transmission model to evaluate vaccine efficacy against naturally acquired bubonic plague.

    PubMed

    Jarrett, Clayton O; Sebbane, Florent; Adamovicz, Jeffrey J; Andrews, Gerard P; Hinnebusch, B Joseph

    2004-04-01

    A flea-to-mouse transmission model was developed for use in testing new candidate vaccines for the ability to protect against flea-borne plague. The model was used to evaluate a recombinant fusion protein vaccine consisting of the Yersinia pestis F1 and V antigens. After one to three challenges with Y. pestis-infected fleas, 14 of 15 unvaccinated control mice developed plague, with an average septicemia level of 9.2 x 10(8) Y. pestis CFU/ml. None of 15 vaccinated mice developed the disease after similar challenges, and serological testing indicated that transmitted bacteria were eliminated by the immune system before extensive replication and systemic infection could occur. The transmission and development of disease in control mice correlated with the number of bites by blocked fleas but not with the total number of fleabites. The model provides a means to directly assess the efficacy of new vaccines to prevent naturally acquired bubonic plague and to study events at the vector-host interface that lead to dissemination and disease.

  7. Evaluation of oral tilmicosin efficacy against severe cryptosporidiosis in neonatal kids under field conditions.

    PubMed

    Paraud, C; Pors, I; Chartier, C

    2010-05-28

    Many compounds have been screened for their potential anti-cryptosporidial activity in ruminants but none of them has been totally efficient in controlling the disease. Macrolide antibiotics have demonstrated some activity against Cryptosporidium spp. in humans. Tilmicosin is a macrolide antibiotic, available in France in an oral form (Pulmotil AC, Lilly France). The preventive efficacy of tilmicosin was evaluated in a goat farm experiencing severe clinical cryptosporidiosis in kids. Twenty-two kids were separated from their dams just after birth and placed in a separated pen. They were divided into 3 groups: an untreated group (10 kids), group 1 (6 kids) receiving tilmicosin at 25mg/kg BW/day and group 2 (6 kids) receiving tilmicosin at 50mg/kg BW/day. Tilmicosin was individually given by oral route from day 2 of age for 10 days. Three times a week, individual faecal samples were performed to assess the oocyst output. Clinical data, i.e. diarrhea and mortality, were recorded. In control kids, the highest prevalence and intensity of excretion were observed between day 6 and day 16 of age and mortality reached 90%. Excretion dynamic and clinical consequences were similar in both treated kid groups. Finally, tilmicosin did not demonstrate any activity against severe kid cryptosporidiosis in field conditions.

  8. Comparative Evaluation of Antibacterial Efficacy of Six Indian Plant Extracts against Streptococcus Mutans

    PubMed Central

    Jain, Pankaj; Bisht, Dakshina; Sharma, Alosha; Srivastava, Binita; Gupta, Nidhi

    2015-01-01

    Introduction: To assess the antimicrobial efficacy of six plant extracts of Indian origin often used as traditional medicine against standard strains of Streptococcus mutans. Materials and Methods: The antimicrobial activity of six plant extracts was determined by the agar well diffusion method. The minimum inhibitory concentration (MIC) for the crude (raw), Organic solvent based, aqueous extracts was determined by the agar well diffusion method. Results: Out of all the six extracts evaluated, organic solvent based and aqueous extracts of all the extracts were found to have variable antimicrobial activities against the oral pathogen. The crude extract of Garlic was the most effective against Streptococcus mutans with the highest zone of inhibition (24.62 mm) followed by the aqueous extract of Amla (19.47mm) and organic solvent based extract of Ginger (18.76 mm). Conclusion: Despite of the fact that the extracts were not pure compounds and antimicrobial results were obtained. This recommends the potency of these extracts. The figment of the derivation of antimicrobial compounds from plants seems lucrative as it will lead to the development of a phytomedicine to act against microbes. PMID:25859526

  9. Evaluation of efficacy of probiotic (BIFILAC) on Porphyromonas gingivalis: In vitro study

    PubMed Central

    Elavarasu, Sugumari; Suthanthiran, Thangakumaran; Thangavelu, Arthiie; Kanagaraj, Shiva Shangkharii; Mohandas, Lakshmi; Sekar, Santhosh

    2016-01-01

    Background: Periodontitis is inflammation of the periodontium and causes destruction of the connective tissue attachment of the teeth and alveolar bone. Porphyromonas gingivalis is the primary pathogen for the destructive periodontal diseases. The aim of the study is to evaluate the efficacy of probiotic on P. gingivalis. Materials and Methods: An in vitro study was done to analyze the effectiveness of probiotic BIFILAC on P. gingivalis was determined using disc diffusion method. The minimum inhibitory concentration for BIFILAC lozenges was also determined using microdilution method. Results: In disc diffusion method, the antibacterial activity of BIFILAC was analyzed using various concentrations such as 2.5, 5, 10, and 20 μg/ml, of which 20 μg/ml was proved to have a maximum inhibitory zone of 22 mm. In microdilution method, concentration ranging from 7.25 to 100 μg/ml was used and 25 μg/ml was found to have the minimum inhibitory effect on P. gingivalis. Conclusion: The present in vitro study confirms that probiotic BIFILAC has an antimicrobial effect against P. gingivalis. Thus, proving that BIFILAC probiotic can be used as an adjunctive therapeutic modality in periodontitis. PMID:27829746

  10. Evaluating the ameliorative efficacy of Spirulina platensis on spermatogenesis and steroidogenesis in cadmium-intoxicated rats.

    PubMed

    Farag, Mayada R; Abd El-Aziz, R M; Ali, H A; Ahmed, Sahar A

    2016-02-01

    The present study was conducted to evaluate the ameliorative efficacy of Spirulina platensis (SP) on reproductive dysfunctions induced by cadmium chloride (CdCl2) in male rats. Rats (n = 40) were divided into five groups (eight rats/each). Group 1: served as control without any treatment. Group 2: Rats were administered SP (150 mg/kg body weight (BW)) in drinking water for 10 days. Group 3: Rats were subcutaneously injected with CdCl2 (2 mg/kg BW) daily for 10 days. Group 4: Rats were co-treated with both CdCl2 (2 mg/kg BW) and SP (150 mg/kg BW) daily for 10 days (SP prophylactic group). Group 5: Rats received CdCl2 for 10 days followed by administration of SP alone in drinking water daily for another 30 days with the same mentioned routes and doses (SP treatment group). From our findings, the administration of SP alone or co-administration with Cd significantly attenuated the harmful effects of Cd, suggesting its beneficial role in improving spermatogenesis and steroidogenesis after Cd exposure.

  11. Bio-efficacy evaluation of nanoformulations of β-cyfluthrin against Callosobruchus maculatus (Coleoptera: Bruchidae).

    PubMed

    Loha, Kumelachew Mulu; Shakil, Najam A; Kumar, Jitendra; Singh, Manish K; Srivastava, Chitra

    2012-01-01

    In the present investigation, bioefficacy of developed β-cyfluthrin formulations, utilizing laboratory synthesized poly(ethylene glycols) based amphiphilic copolymers, were evaluated against Callosobruchus maculatus (Coleoptera: Bruchidae). The bioefficacy data indicated that the formulations developed by utilizing polymers having PEG - 1500 (3c) and PEG - 2000 (3d) as the hydrophilic segment showed greater efficacy after 14 days as evident from EC(50) values (2.2 and 1.58 mg L(-1) respectively). Also, release from the commercial SC formulation was faster than developed formulations as the commercial formulation had the lowest EC(50) value on the first day (0.51 mg L(-1)). The mean EC(50) of the commercial formulation against C. maculatus was quite high as compared to those of developed formulations. The results suggest that depending upon the polymer matrix used, the application rate of β-cyfluthrin can be optimized to achieve insect control at the desired level and period. The results described in this paper are promising and provide a comparison of developed formulations with the commercial one showing an earlier degradation of β-cyfluthrin in the latter and relatively prolonged activity in the former.

  12. Quantitative evaluation of hyperbaric oxygen efficacy in experimental traumatic brain injury: an MRI study.

    PubMed

    Wei, Xiao-Er; Li, Yue-Hua; Zhao, Hui; Li, Ming-Hua; Fu, Min; Li, Wen-Bin

    2014-02-01

    To use DCE-magnetic resonance imaging (MRI) and diffusion-weighted imaging to evaluate the hyperbaric oxygen efficacy (HBO) in experimental traumatic brain injury (TBI). Forty-two rabbits were randomly divided into four groups: TBI, TBI + HBO, sham group, sham + HBO. The TBI + HBO and sham + HBO received a total of 10 HBO treatments within 7 days following TBI, and MRI was performed within a month after TBI. Functional assessments were performed pre-TBI, and at 1 and 30 days. In focal lesion area, K(trans) in TBI + HBO group was lower than TBI group at both acute and subacute phase (p < 0.05). ADC was higher in TBI + HBO group than TBI group at acute phase (p < 0.01), but lower at subacute phase (p < 0.05). In perifocal area, K(trans) were lower in TBI + HBO group than TBI group at acute phase (p < 0.01) after TBI. ADC was lower in the TBI + HBO group than in the TBI group at both acute and subacute phase (p < 0.01).The VCS was higher in TBI + HBO group than TBI group at 30 days (p < 0.05). HBO could improve the impaired BBB and cytotoxic edema after TBI and promote the recovery of neurofunction.

  13. Item Response Modeling: An Evaluation of the Children's Fruit and Vegetable Self-Efficacy Questionnaire

    ERIC Educational Resources Information Center

    Watson, Kathy; Baranowski, Tom; Thompson, Debbe

    2006-01-01

    Perceived self-efficacy (SE) for eating fruit and vegetables (FV) is a key variable mediating FV change in interventions. This study applies item response modeling (IRM) to a fruit, juice and vegetable self-efficacy questionnaire (FVSEQ) previously validated with classical test theory (CTT) procedures. The 24-item (five-point Likert scale) FVSEQ…

  14. Evaluating High School Students' Anxiety and Self-Efficacy towards Biology

    ERIC Educational Resources Information Center

    Çimen, Osman; Yilmaz, Mehmet

    2015-01-01

    Anxiety and self-efficacy are among the factors that impact students' performance in biology. The current study aims to investigate high school students' perception of biology anxiety and self-efficacy, in relation to gender, grade level, interest in biology, negative experience associated with biology classes, and teachers' approaches in the…

  15. Human Patient Simulations: Evaluation of Self-Efficacy and Anxiety in Clinical Skills Performance

    ERIC Educational Resources Information Center

    Onovo, Grace N.

    2013-01-01

    The relationship between self-efficacy (self-confidence) and anxiety levels, and the use of Human Patient Simulations (HPS) as a teaching-learning strategy, has not been sufficiently studied in the area of clinical nursing education. Despite the evidence in the literature indicating that HPS increases self-efficacy/self-confidence and decreases…

  16. Professional Development for Character Education: An Evaluation of Teachers' Sense of Efficacy for Character Education

    ERIC Educational Resources Information Center

    Ledford, Alice T.

    2011-01-01

    Today's teachers and administrators must educate students for character. But, teachers are inconsistently prepared for this challenge. This descriptive study examined teachers' sense of efficacy for character education among pre-K-12 teachers based on their type of character education training. The Character Education Efficacy Belief Instrument…

  17. The Study, Evaluation, and Improvement of University Student Self-Efficacy

    ERIC Educational Resources Information Center

    Bartimote-Aufflick, Kathryn; Bridgeman, Adam; Walker, Richard; Sharma, Manjula; Smith, Lorraine

    2016-01-01

    In this review of 64 articles published since the year 2000, a strong association between self-efficacy and student learning outcomes was apparent. Self-efficacy is also related to other factors such as value, self-regulation and metacognition, locus of control, intrinsic motivation, and strategy learning use. The review revealed that university…

  18. Evaluating Corrective Feedback Self-Efficacy Changes among Counselor Educators and Site Supervisors

    ERIC Educational Resources Information Center

    Motley, Veronica; Reese, Mary Kate; Campos, Peter

    2014-01-01

    Analysis of pretest-posttest scores on the Corrective Feedback Self-Efficacy Instrument (Page & Hulse-Killacky, [Page, B. J., 1999]) following a supervision workshop indicated a significant positive relationship between workshop training and supervisors' feedback self-efficacy in giving corrective feedback. Furthermore, the association…

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

    ERIC Educational Resources Information Center

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

    2015-01-01

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

  20. In vivo efficacy of ferrihydrite as an enterosorbent for arsenic: short-term evaluation in rodents.

    PubMed

    Taylor, John F; Robinson, Abraham; Mitchell, Nicole J; Marroquin-Cardona, Alicia; Johnson, Natalie; Elmore, Sarah E; Romoser, Amelia A; Phillips, Timothy D

    2013-01-01

    The use of dietary adsorbents to reduce arsenic (As) exposure is innovative. Ferrihydrite successfully sorbs arsenite and asenate over a wide range of pH conditions and the As-ferrihydrite complexes are stable in gastrointestinal (GIT) models. Our objectives were to (1) compare structural characteristics (using x-ray diffraction and Fourier-transform infrared [FTIR] spectroscopy) and As binding affinities of industrially produced ferrihydrite (IDF) and lab-synthesized ferrihydrite and (2) evaluate the efficacy of the material displaying the best sorption capability as an As enterosorbent in a short-term mammalian model. Lab-synthesized ferrihydrite displayed superior binding affinity for both arsenate and arsenite in vitro, which led to its use in the in vivo portion of the study. Young Sprague-Dawley male rats were fed either a control diet or a 0.5% w/w ferrihydrite feed. After 1 wk of acclimation, rats were given 0.5 ml of 500 mg/L arsenate or arsenite via gavage with or without ferrihydrite. Rats were then transferred to metabolism cages, and urine collected after 24 and 48 h was analyzed for total As. Rats were evaluated daily for signs of morbidity and mortality for up to 1 wk. Ferrihydrite reduced mean urinary As levels by 74.9% and 43.6% after 24 h and 49.1% and 39.5% after 48 h for arsenite- and arsenate-treated groups, respectively. Importantly, treatment groups receiving ferrihydrite displayed no signs of As-related toxicity. All As reductions were statistically significant except for arsenate treatments at 24 h. Data suggest that, as an enterosorbent, ferrihydrite reduces bioavailability after As exposures.

  1. Characterization of a Cynomolgus Macaque Model of Pneumonic Plague for Evaluation of Vaccine Efficacy

    PubMed Central

    Price, Jessica; Martin, Shannon; Metcalfe, Karen; Krile, Robert; Barnewall, Roy; Hart, Mary Kate; Lockman, Hank

    2015-01-01

    The efficacy of a recombinant plague vaccine (rF1V) was evaluated in cynomolgus macaques (CMs) to establish the relationship among vaccine doses, antibody titers, and survival following an aerosol challenge with a lethal dose of Yersinia pestis strain Colorado 92. CMs were vaccinated with a range of rF1V doses on a three-dose schedule (days 0, 56, and 121) to provide a range of survival outcomes. The humoral immune response following vaccination was evaluated with anti-rF1, anti-rV, and anti-rF1V bridge enzyme-linked immunosorbent assays (ELISAs). Animals were challenged via aerosol exposure on day 149. Vaccine doses and antibody responses were each significantly associated with the probability of CM survival (P < 0.0001). Vaccination also decreased signs of pneumonic plague in a dose-dependent manner. There were statistically significant correlations between the vaccine dose and the time to onset of fever (P < 0.0001), the time from onset of fever to death (P < 0.0001), the time to onset of elevated respiratory rate (P = 0.0003), and the time to onset of decreased activity (P = 0.0251) postinfection in animals exhibiting these clinical signs. Delays in the onset of these clinical signs of disease were associated with larger doses of rF1V. Immunization with ≥12 μg of rF1V resulted in 100% CM survival. Since both the vaccine dose and anti-rF1V antibody titers correlate with survival, rF1V bridge ELISA titers can be used as a correlate of protection. PMID:26224691

  2. Characterization of a Cynomolgus Macaque Model of Pneumonic Plague for Evaluation of Vaccine Efficacy.

    PubMed

    Fellows, Patricia; Price, Jessica; Martin, Shannon; Metcalfe, Karen; Krile, Robert; Barnewall, Roy; Hart, Mary Kate; Lockman, Hank

    2015-09-01

    The efficacy of a recombinant plague vaccine (rF1V) was evaluated in cynomolgus macaques (CMs) to establish the relationship among vaccine doses, antibody titers, and survival following an aerosol challenge with a lethal dose of Yersinia pestis strain Colorado 92. CMs were vaccinated with a range of rF1V doses on a three-dose schedule (days 0, 56, and 121) to provide a range of survival outcomes. The humoral immune response following vaccination was evaluated with anti-rF1, anti-rV, and anti-rF1V bridge enzyme-linked immunosorbent assays (ELISAs). Animals were challenged via aerosol exposure on day 149. Vaccine doses and antibody responses were each significantly associated with the probability of CM survival (P < 0.0001). Vaccination also decreased signs of pneumonic plague in a dose-dependent manner. There were statistically significant correlations between the vaccine dose and the time to onset of fever (P < 0.0001), the time from onset of fever to death (P < 0.0001), the time to onset of elevated respiratory rate (P = 0.0003), and the time to onset of decreased activity (P = 0.0251) postinfection in animals exhibiting these clinical signs. Delays in the onset of these clinical signs of disease were associated with larger doses of rF1V. Immunization with ≥ 12 μg of rF1V resulted in 100% CM survival. Since both the vaccine dose and anti-rF1V antibody titers correlate with survival, rF1V bridge ELISA titers can be used as a correlate of protection.

  3. Single-balloon enteroscopy efficacy and degree of concordance with noninvasive evaluation of small bowel

    PubMed Central

    Marques, Margarida; Antunes, João; Coelho, Rosa; Cardoso, Hélder; Vilas Boas, Filipe; Ribeiro, Armando; Macedo, Guilherme

    2017-01-01

    Background and study aims Clinical impact of single-balloon enteroscopy (SBE) is fairly known, as well as its diagnostic yield comparing with other small bowel gastrointestinal investigations. This study represents a contribution to better understand it and is designed to evaluate SBE efficacy and degree of concordance with previous evaluation of small bowel. Patients and methods This is a single-center retrospective study of patients that underwent SBE with suspected small bowel disease based on non-invasive imaging. Demographic, clinical, procedural and outcome data were collected for analysis. Agreement beyond positive findings was evaluated using κ-coefficient. Results A total of 197 SBEs were performed in 168 patients; mainly men (64.3 %) with mean age 53.3±17.6 years. Most SBEs (86.3 %) performed were preceded by a noninvasive evaluation: in 61.4 % (n = 119) of cases, capsule enteroscopy (CE) was performed, in 18.8 % (n = 37), computed tomography was performed, and in 6.1 % (n = 12) magnetic resonance enterography was performed. Fourty-three patients (25.6 %) underwent endoscopic treatments, mainly: argon plasma coagulation in angioectasias (53.4 %) and polypectomy (34.9 %). The most common diagnoses made with SBE were findings consistent with inflammatory small bowel disease (21.8 %) and vascular lesions (14.2 %). The diagnostic yield of SBE was of 69 %, confirming the suspicion of small bowel disease. The degree of concordance between CE and SBE for positive findings was substantial, κ-coefficient = 0.635 (P < 0.001). However, the degree of concordance between imaging examinations (CT or MR) and SBE was only moderate, κ-coefficient = 0.410 (P < 0.001). SBE had an immediate effect in 20 % of patients, changing diagnostic approaches, medical and surgical treatments. Conclusions Our study supports the idea that for suspected small bowel disease, CE and SBE have an overall good degree of

  4. Evaluation of the safety and efficacy of radiofrequency ablation for treating benign thyroid nodules

    PubMed Central

    Tang, Xiaoyin; Cui, Dan; Chi, Jiachang; Wang, Zhi; Wang, Tao; Zhai, Bo; Li, Ping

    2017-01-01

    Background: Radiofrequency ablation (RFA) is a relatively new procedure for treating benign thyroid nodules. The purpose of this study was to evaluate the safety and efficacy of RFA for treating benign thyroid nodules so as to serve as a reference for future clinical practice. Methods: This study retrospectively analyzed the clinical data of patients receiving percutaneous RFA for treating thyroid nodules from November 2014 to July 2015 in our medical center. One hundred and eight patients with a total of 380 nodules received ultrasound-guided RFA for treating thyroid nodules. Comparisons of the volume change of thyroid nodules before and after RFA treatment, post-treatment complication, and change of thyroid function, were carried out afterwards. Results: Before treatments, all patients received fine needle aspiration biopsy (FNA) which supported the diagnosis of benign tumor. There were 13 males and 95 females included in the study. Twenty-six cases (24.07%) had single nodule, and 82 cases (75.93%) had multiple nodules. Before treatments, the thyroid functions (FT3, FT4, and TSH) were normal originally or adjusted to normal range by endocrinology treatment. The preoperative nodules had minimum volume of 0.01mL, maximum volume of 70.89 mL, and mean volume of 1.02 ± 4.24mL. The volume of nodules one month and three months after RFA were 0.29 ± 0.72mL and 0.15 ± 0.87mL, respectively. In addition, volume reduction ratio (VRR) of nodules one month and three months after RFA were 64.12% and 85.54%, respectively. Both volume of nodules and VRR had statistically significant differences for pre-operative and post-operative comparison (P<0.05). Thyroid functions were in normal range after treatments, and there was no serious complications. Conclusions: Ultrasound-guided RFA treating benign thyroid nodules had the advantages of definite efficacy, safety, strong in control ability, no incision, less damage to surrounding normal tissues and no effect on thyroid function

  5. [Evaluation of safety and efficacy of tebipenem pivoxil granules for pediatric in pneumonia, otitis media and sinusitis].

    PubMed

    Kataoka, Hiroshi; Kasahara, Hiroshi; Sasagawa, Yuji; Matsumoto, Masato; Shimada, Seiya

    2016-02-01

    We conducted a postmarketing surveillance of tebipenem pivoxil granules (Orapenem® fine granules 10% for pediatric), an oral carbapenem antibacterial agent, between April 2010 and March 2013 to evaluate the safety and efficacy in patients with pneumonia or otitis media, or sinusitis Of 3,547 patients enrolled, 3,540 from whom survey forms were collected were analyzed. Of these 3,540 patients, there were a total of 3,331 patients included in the safety analysis, 2,844 in the efficacy analysis, 2,769 in the clinical efficacy analysis, and 461 in the bacteriological efficacy analysis. The incidence of adverse drug reactions (ADRs) was 9.97% (332/3,331 patients), and the major ADRs were gastrointestinal disorders including diarrhoea in 317 patients (9.52%). Diarrhoea was reported in 313 patients (316 events), which were not clinically significant and 94.9% (297/313 patients) were recovery and/or remission. The overall clinical efficacy rate was 94.0% (2,604/2,769 patients). The clinical efficacy rate by the type of infection was 95.6% (415/434 patients) for pneumonia, 93.7% (1,389/1,482 patients) for otitis media and 93.6% (659/704 patients) for sinusitis. The eradication rate of Streptococcus pneumoniae, Haemophilus influenzae and Moraxella (Branhamella) catarrhalis which are major causative organisms in pediatric infection of pneumonia, otitis media and sinusitis were 94.4% (134/142 strains), 92.2% (130/141 strains) and 97.8% (45/46 strains), respectively. The compliance was good in 83.1% of the patients (2,767/3,331 patients). Overall, Orapenem® fine granules 10% for pediatric showed good safety, efficacy, and compliance. These results indicate that Orapenem® fine granules 10% for pediatric is a useful agent in pediatrics with pneumonia or otitis media, or sinusitis.

  6. Efficacy of methylprednisolone and lignocaine on propofol injection pain: A randomised, double-blind, prospective study in adult cardiac surgical patients

    PubMed Central

    Shivanna, Shivaprakash; Priye, Shio; Singh, Dipali; Jagannath, Sathyanarayan; Mudassar, Syed; Reddy, Durga Prasad

    2016-01-01

    Background and Aims: Propofol (2, 6-di-isopropylphenol) used for the induction of anaesthesia often causes mild to severe pain or discomfort on injection. We designed this double-blind study to compare the efficacy of methylprednisolone and lignocaine in reducing the pain of propofol injection in patients scheduled for cardiac surgery. Methods: A total of 165 adult patients, scheduled for elective cardiac surgery, were divided into three groups: saline (group S, n = 55), lignocaine 20 mg (Group L, n = 55) and methylprednisolone 125 mg diluted into 2 ml of distilled water (Group MP, n = 55). Drugs were administered after tourniquet application and occlusion was released after 1 min and 1/4th of the total dose of propofol (2 mg/kg) was administered at the rate of 0.5 ml/s. Pain on propofol injection was evaluated by four-point verbal rating scale. Statistical methods used included Student's t-test and Chi-square test/Fisher's exact test. Results: The overall incidence of pain was 70.9% in the saline group, 30.9% in the lignocaine group and 36.4% in the methylprednisolone group. The intensity of pain was significantly less in patients receiving methylprednisolone and lignocaine than those receiving saline (P < 0.012). Conclusion: Pre-treatment with intravenous methylprednisolone was found to be as effective as lignocaine in reducing propofol injection-induced pain. PMID:27942060

  7. [Molecular evaluation on the efficacy of sustainable control of Monochamus alternatus by non-woven fabric fungal bands impregnated with Beauveria bassiana].

    PubMed

    Ding, De-Gui; Fan, Mei-Zhen; Meng, Yan-Qiong; Li, Zeng-Zhi; Xia, Cheng-Run

    2007-03-01

    By using molecular marker of group I intron, a field evaluation was made on the efficacy of sustainable control of Monochamus alternatus by non-woven fabric bands impregnated with Beauveria bassiana. The results showed that the control efficacy in two treated plots was 19.5% and 10.8%, and 14.2% and 11% when evaluated with conventional and molecular evaluation methods, respectively, suggesting that the conventional method which evaluated the control efficacy in terms of microbes mortality or infection rate couldn't distinguish the efficacies caused by released biocontrol agents and indigenous pathogens, while molecular method could avoid the interference of indigenous pathogens and give an objective and reasonable evaluation on the efficacy of microbial control.

  8. Evaluation of the Efficacy of ME1111 in the Topical Treatment of Dermatophytosis in a Guinea Pig Model

    PubMed Central

    Long, L.; Hager, C.

    2016-01-01

    The treatment of dermatophytoses, including onychomycosis, has come a long way over the past few decades with the introduction of oral antifungals (e.g., terbinafine and itraconazole). However, with these advancements in oral therapies come several undesirable effects, such as kidney and liver toxicity, along with drug-drug interactions. Consequently, there is a need for new topical agents that are effective against dermatophytosis. ME1111 is a topical antifungal under development. In this study, the in vivo efficacy of ME1111 was compared to that of ciclopirox in the topical treatment of dermatophytosis caused by Trichophyton mentagrophytes using a guinea pig model. Animals were treated with the topical antifungals starting at 3 days postinfection, with each agent being applied once daily for seven consecutive days. After the treatment period, the clinical and mycological efficacies were evaluated. The data showed that both antifungals demonstrated significant clinical and mycological efficacies; however, ME1111 showed clinical efficacy superior to that of ciclopirox (46.9% and 25.0%, respectively, with a P value of <0.001). The potent efficacy of ME1111 could be attributed to its properties, such as low keratin binding. PMID:26833160

  9. An Open-Label Evaluator Blinded Study of the Efficacy and Safety of a New Nutritional Supplement in Androgenetic Alopecia: A Pilot Study

    PubMed Central

    Nichols, Anna J.; Hughes, Olivia Bosshardt; Canazza, Agnese

    2017-01-01

    Objective: To evaluate the effectiveness of a novel oral supplement, Forti5®, containing green tea extract, omega 3 and 6 fatty acids, cholecalciferol, melatonin, beta-sitosterol, and soy isoflavones, and in the management of subjects with androgenetic alopecia. Design: A prospective case series of 10 subjects. Setting: Open-label, evaluator-blinded, proof-of-concept study. Participants: Ten adult subjects with androgenetic alopecia completed the study. Subjects were not allowed to use oral or topical hair growth products in the 24 weeks preceding the study or during the study. The nutritional supplement was administered at a dosage of two tablets daily for 24 weeks. Measurements: Clinical evaluations were performed at baseline and at 24 weeks. Efficacy was evaluated using hair mass index measured by cross section trichometer, terminal hair count measured with dermoscopy and Investigator Global Photography Assessment. Results: Overall 80 percent of subjects (8/10) were rated as improved after 24 weeks of supplementation (mean change of +1.4 equivalent to slightly-to-moderately increased). Forty percent of subjects (4/10) were rated as moderately improved (2+), and 10 percent (1/10) were rated as greatly improved (3+). There was a significant improvement in terminal hair count (mean increase of 5.9% or 4.2 more terminal hairs in the area examined, p=0.014) and in Hair Mass Index (mean increase of 9.5% or 4.5 higher Hair Mass Index, p=0.003). Conclusion: These preliminary results indicate that Forti5® a novel nutritional supplement that contains cholecalciferol, omega 3 and 6 fatty acids, melatonin, antioxidants, and botanical 5-alpha reductase inhibitors, may be a useful adjunct in the treatment of androgenetic alopecia. PMID:28367262

  10. Evaluation of efficacy and tolerability of glimepiride and metformin combination: a multicentric study in patients with type-2 diabetes mellitus, uncontrolled on monotherapy with sulfonylurea or metformin.

    PubMed

    Pareek, Anil; Chandurkar, Nitin B; Salkar, Harsha R; Borkar, Mangala S; Tiwari, Dharmendra

    2013-01-01

    The objectives of this study were to evaluate the efficacy and tolerability of glimepiride plus extended release metformin (MET) on glycemic control in patients with type-2 diabetes mellitus uncontrolled on monotherapy with sulfonylurea or MET. This was a prospective, open-labeled, multicentric study over 12 weeks. Patients who were diagnosed with type-2 diabetes and were uncontrolled on monotherapy with single oral hypoglycemic agents such as glimepiride or MET and characterized by glycosylated hemoglobin (HbA1c) ≥7% and ≤10% and fasting plasma glucose (FPG) ≥ 140 mg/dL were enrolled in this study. Treatment regimen was started at 1 mg of glimepiride plus 500 mg of MET once a day and was titrated to next dose level depending on the clinician's judgment, not exceeding a total daily dose of 8 mg of glimepiride and 2000 mg of MET. After 12-weektreatment, glimepiride plus MET combination showed improvement in metabolic control as assessed by changes in HbA1c, FPG, and post prandial glucose (PPG). Primary efficacy parameter, HbA1c, was significantly reduced to (7.65 ± 1.70) at the end of the treatment from the baseline value (8.35 ± 0.93) (P < 0.001). Of the patients, 65.79% showed ≥0.5% reduction in HbA1c and or HbA1c <7% at the end of the therapy. FPG and PPG were significantly reduced at the end of the therapy as compared with baseline values (P < 0.001). Moreover, the lipid profile was also improved during the treatment period. The addition of glimepiride to MET is an effective treatment for patients inadequately controlled on sulfonylurea or Met alone. A combination of glimepiride with MET achieves good glycemic control with better tolerability profile.

  11. Evaluation of Synergistic Antibacterial and Antioxidant Efficacy of Essential Oils of Spices and Herbs in Combination.

    PubMed

    Bag, Anwesa; Chattopadhyay, Rabi Ranjan

    2015-01-01

    The present study was carried out to evaluate the possible synergistic interactions on antibacterial and antioxidant efficacy of essential oils of some selected spices and herbs [bay leaf, black pepper, coriander (seed and leaf), cumin, garlic, ginger, mustard, onion and turmeric] in combination. Antibacterial combination effect was evaluated against six important food-borne bacteria (Bacillus cereus, Listeria monocytogenes, Micrococcus luteus, Staphylococcus aureus, Escherichia coli and Salmonella typhimurium) using microbroth dilution, checkerboard titration and time-kill methods. Antioxidant combination effect was assessed by DPPH free radical scavenging method. Total phenolic content was measured by Folin-Ciocalteu method. Bioactivity -guided fractionation of active essential oils for isolation of bioactive compounds was done using TLC-bioautography assay and chemical characterization (qualitative and quantitative) of bioactive compounds was performed using DART-MS and HPLC analyses. Cytotoxic potential was evaluated by brine shrimp lethality assay as well as MTT assay using human normal colon cell line. Results showed that among the possible combinations tested only coriander/cumin seed oil combination showed synergistic interactions both in antibacterial (FICI : 0.25-0.50) and antioxidant (CI : 0.79) activities. A high positive correlation between total phenolic content and antibacterial activity against most of the studied bacteria (R2 = 0.688 - 0.917) as well as antioxidant capacity (R2 = 0.828) was also observed. TLC-bioautography-guided screening and subsequent combination studies revealed that two compounds corresponding to Rf values 0.35 from coriander seed oil and 0.53 from cumin seed oil exhibited both synergistic antibacterial and antioxidant activities. The bioactive compound corresponding to Rf 0.35 from coriander seed oil was identified as linalool (68.69%) and the bioactive compound corresponding to Rf 0.53 from cumin seed oil was identified as p

  12. Evaluation of Synergistic Antibacterial and Antioxidant Efficacy of Essential Oils of Spices and Herbs in Combination

    PubMed Central

    Bag, Anwesa; Chattopadhyay, Rabi Ranjan

    2015-01-01

    The present study was carried out to evaluate the possible synergistic interactions on antibacterial and antioxidant efficacy of essential oils of some selected spices and herbs [bay leaf, black pepper, coriander (seed and leaf), cumin, garlic, ginger, mustard, onion and turmeric] in combination. Antibacterial combination effect was evaluated against six important food-borne bacteria (Bacillus cereus, Listeria monocytogenes, Micrococcus luteus, Staphylococcus aureus, Escherichia coli and Salmonella typhimurium) using microbroth dilution, checkerboard titration and time-kill methods. Antioxidant combination effect was assessed by DPPH free radical scavenging method. Total phenolic content was measured by Folin-Ciocalteu method. Bioactivity –guided fractionation of active essential oils for isolation of bioactive compounds was done using TLC-bioautography assay and chemical characterization (qualitative and quantitative) of bioactive compounds was performed using DART-MS and HPLC analyses. Cytotoxic potential was evaluated by brine shrimp lethality assay as well as MTT assay using human normal colon cell line. Results showed that among the possible combinations tested only coriander/cumin seed oil combination showed synergistic interactions both in antibacterial (FICI : 0.25-0.50) and antioxidant (CI : 0.79) activities. A high positive correlation between total phenolic content and antibacterial activity against most of the studied bacteria (R2 = 0.688 – 0.917) as well as antioxidant capacity (R2 = 0.828) was also observed. TLC-bioautography-guided screening and subsequent combination studies revealed that two compounds corresponding to Rf values 0.35 from coriander seed oil and 0.53 from cumin seed oil exhibited both synergistic antibacterial and antioxidant activities. The bioactive compound corresponding to Rf 0.35 from coriander seed oil was identified as linalool (68.69%) and the bioactive compound corresponding to Rf 0.53 from cumin seed oil was identified

  13. Evaluation of a waterless, scrubless chlorhexidine gluconate/ethanol surgical scrub for antimicrobial efficacy.

    PubMed

    Mulberrry, G; Snyder, A T; Heilman, J; Pyrek, J; Stahl, J

    2001-12-01

    A new waterless surgical hand preparation containing 1% chlorhexidine gluconate (CHG) and 61% ethyl alcohol was evaluated for antimicrobial efficacy in comparison with a standard 4% CHG surgical scrub and a 61% ethyl alcohol control. Clinical studies were based on the Tentative Final Monograph for Health-Care Antiseptic Drug Products (TFM) (proposed rule) and the Standard Test Method for Evaluation of Surgical Hand Scrub Formulations (ASTM E1115-91). Two randomized, blinded, well-controlled clinical studies involving 137 healthy subjects were conducted to evaluate the antimicrobial effectiveness of the CHG/ethanol hand preparation in producing an immediate and persistent reduction in the normal bacterial flora of the hands. The CHG/ethanol hand preparation was applied without scrubbing or the use of water, and a standard 4% CHG reference product was applied with a scrub brush in 2 traditional 3-minute surgical scrubs. In 1 study, a 61% ethanol vehicle control treatment was applied without scrubbing or use of water. During a 5-day period, each study subject performed a series of 11 surgical scrubs with 1 of the test treatments. After the first treatment on days 1, 2, and 5, surgical gloves were worn for 3 or 6 hours. Bacterial samples were taken with the glove-juice technique at 1 minute, 3 hours, and 6 hours after treatment. The immediate bactericidal effect of the CHG/ethanol hand preparation after a single application resulted in a 2.5-log reduction in normal flora. This bactericidal effect persisted throughout the studies and eventually increased to a 3.6-log reduction after the 11th scrub on day 5. The log reductions of the CHG/ethanol hand preparation proved to be significantly better (P <.05) than that of the 4% CHG product at each sampling interval on days 1 and 2 and the sampling at 6 hours on day 5 and significantly better than the 61% ethanol vehicle at all times. The combination of 1% CHG and 61% ethanol had significantly greater microbial reduction than

  14. Evaluation of efficacy of transcatheter arterial chemoembolization for hepatocellular carcinoma using magnetic resonance diffusion-weighted imaging

    PubMed Central

    Wu, Xiao-Ming; Wang, Jun-Feng; Ji, Jian-Song; Chen, Ming-Gao; Song, Jian-Gang

    2017-01-01

    Although the efficacy of transcatheter arterial chemoembolization (TACE) has been recommended as first-line therapy for nonsurgical patients with hepatocellular carcinoma (HCC), it is difficult to accurately predict the efficacy of TACE. Therefore, this study evaluated the efficacy of TACE for HCC using magnetic resonance (MR) diffusion-weighted imaging (DWI). A total of 84 HCC patients who received initial TACE were selected and assigned to the stable group (n=39) and the progressive group (n=45). Before TACE treatment, a contrast-enhanced MR scan and DWI (b=300, 600, and 800 s/mm2) were performed on all patients. The modified response evaluation criteria in solid tumors were used for evaluation of tumor response. Receiver operating characteristic curve was employed to predict the value of apparent diffusion coefficient (ADC) for TACE efficacy. The ADC values of HCC patients in the progressive group were higher than those in the stable group at different b-values (b=300, 600, and 800 s/mm2) before TACE treatment. The area under the curve of ADC values with b-values of 300, 600, and 800 s/mm2 were 0.693, 0.724, and 0.746; the threshold values were 1.94×10−3 mm2/s, 1.28×10−3 mm2/s, and 1.20×10−3 mm2/s; the sensitivity values were 55.6%, 77.8%, and 73.3%; and the specificity values were 82.1%, 61.5%, and 71.8%, respectively. Our findings indicate that the ADC values of MR-DWI may accurately predict the efficacy of TACE in the treatment of HCC patients. PMID:28352195

  15. Efficacy of cognitive behavioural therapy for sleep improvement in patients with persistent delusions and hallucinations (BEST): a prospective, assessor-blind, randomised controlled pilot trial

    PubMed Central

    Freeman, Daniel; Waite, Felicity; Startup, Helen; Myers, Elissa; Lister, Rachel; McInerney, Josephine; Harvey, Allison G; Geddes, John; Zaiwalla, Zenobia; Luengo-Fernandez, Ramon; Foster, Russell; Clifton, Lei; Yu, Ly-Mee

    2015-01-01

    Summary Background Sleep disturbance occurs in most patients with delusions or hallucinations and should be treated as a clinical problem in its own right. However, cognitive behavioural therapy (CBT)—the best evidence-based treatment for insomnia—has not been tested in this patient population. We aimed to pilot procedures for a randomised trial testing CBT for sleep problems in patients with current psychotic experiences, and to provide a preliminary assessment of potential benefit. Methods We did this prospective, assessor-blind, randomised controlled pilot trial (Better Sleep Trial [BEST]) at two mental health centres in the UK. Patients (aged 18–65 years) with persistent distressing delusions or hallucinations in the context of insomnia and a schizophrenia spectrum diagnosis were randomly assigned (1:1), via a web-based randomisation system with minimisation to balance for sex, insomnia severity, and psychotic experiences, to receive either eight sessions of CBT plus standard care (medication and contact with the local clinical team) or standard care alone. Research assessors were masked to group allocation. Assessment of outcome was done at weeks 0, 12 (post-treatment), and 24 (follow-up). The primary efficacy outcomes were insomnia assessed by the Insomnia Severity Index (ISI) and delusions and hallucinations assessed by the Psychotic Symptoms Rating Scale (PSYRATS) at week 12. We did analysis by intention to treat, with an aim to provide confidence interval estimation of treatment effects. This study is registered with ISRCTN, number 33695128. Findings Between Dec 14, 2012, and May 22, 2013, and Nov 7, 2013, and Aug 26, 2014, we randomly assigned 50 patients to receive CBT plus standard care (n=24) or standard care alone (n=26). The last assessments were completed on Feb 10, 2015. 48 (96%) patients provided follow-up data. 23 (96%) patients offered CBT took up the intervention. Compared with standard care, CBT led to reductions in insomnia in the large

  16. Laparoscopic adjustable silicone gastric banding: prospective evaluation of intragastric migration of the lap-band.

    PubMed

    Silecchia, G; Restuccia, A; Elmore, U; Polito, D; Perrotta, N; Genco, A; Bacci, V; Basso, N

    2001-08-01

    Intragastric prosthesis (Lap-Band, BioEnterics Co., Carpinteria, CA, U.S.A.) migration is one of the major long-term complications of laparoscopic adjustable silicone gastric banding. The causes, clinical signs, timing, and overall incidence of band entrapment have not been prospectively investigated in a large series. The purpose of this study was to assess prospectively the incidence of Lap-Band intragastric migration and to establish the safety and effectiveness of minimally invasive band removal. Between January 1996 and June 2000, 148 consecutive patients enrolled in a multidisciplinary bariatric program underwent laparoscopic adjustable silicone gastric banding. In the follow-up treatment, gastrointestinal endoscopy was performed routinely. One hundred twenty-three patients with a minimum follow-up period of 12 months were entered into the study group. Eleven (9.2%) patients had long-term major complications. Intragastric band migration was observed in nine (7.5%) patients. The diagnosis was established by routine endoscopy between 10 and 41 months after surgery. Five erosions occurred in the first 30 cases (learning curve period). In six patients, the band was removed by an intragastric endoscopic-assisted approach avoiding laparotomy. The remaining three patients are under endoscopic surveillance. The results of this study show that routine upper gastrointestinal endoscopy can discover asymptomatic band migrations early. Band erosion did not require emergency treatment and can be removed safely by a minimally invasive approach.

  17. Prospective audit to evaluate the potential of the coronial system to increase solid organ donation

    PubMed Central

    Twamley, Huw; Haigh, Andrew; Williment, Claire; Hudson, Cara; Whitney, Julie; Neuberger, James

    2016-01-01

    Objectives Anecdotal evidence suggests that organ donation from deceased donors referred to the Coroner/Procurator Fiscal (PF) could be increased if all followed best practice. The aim of this prospective audit was to establish how referrals affected organ donation and to develop evidence-based guidelines to ensure that organ donation can be facilitated safely without interfering in the Coroner/PF's investigative process. Design Prospective audit. Setting All acute National Health Service Hospitals in the UK where deceased organ donation was considered. Participants 1437 deceased patients who met the eligibility criteria for organ donation and were referred to Coroner/PF. Main outcome measures Number of cases where permission for transplantation was given, number of organs where permission was refused and number of organs which might have been transplanted if all had followed best practice. Results Full permission for organ retrieval was given in 87% cases and partial permission in 9%. However, if full permission had been given where no autopsy was performed or restrictions seemed unjustified, up to 77 organs (22 lungs, 22 kidneys, 9 pancreases, 9 livers, 8 hearts and 7 small bowels) could have been available for transplant. Conclusions Coroners/PFs and their officers show strong support for transplantation but improvement in practice could result in a small but significant increase in life-saving and life-enhancing transplants. PMID:27401356

  18. Evaluation of the pharmacotherapeutic efficacy of Garcinia cambogia plus Amorphophallus konjac for the treatment of obesity.

    PubMed

    Vasques, Carlos A R; Rossetto, Simone; Halmenschlager, Graziele; Linden, Rafael; Heckler, Eliane; Fernandez, Maria S Poblador; Alonso, José L Lancho

    2008-09-01

    Hydroxycitric acid (HCA), the main compound of Garcinia cambogia extract, is a competitive blocker of ATP-citrate-lyase, presenting a potential inhibition of fatty acid biosynthesis. Glucomannan fibers, abundant in Amorphophallus konjac, seem to reduce the absorption kinetics of dietary fat. Therefore, the aim of this double-blind randomized study was to evaluate the pharmacotherapeutic efficacy of standardized extracts of G. cambogia (52.4% HCA) plus A. konjac (94.9% glucomannan) in the treatment of obesity. Fifty-eight obese subjects (BMI 30.0-39.9 kg/m(2)) were assigned to the placebo group (n = 26) or the treatment group (n = 32); no dietary restrictions were applied. Over a 12-week period, subjects were given daily doses of either Garcinia (2.4 g) plus Konjac (1.5 g) or placebo prior to their main meals (3 times/day). Before the start of treatment, and every 4 weeks thereafter, the following were recorded: height, weight, circumferences and body composition, resting energy expenditure (REE), lipid profile and glucose levels. The treatment had no significant effect on anthropometric parameters, REE, triglycerides or glucose levels. However, a significant reduction was observed in total cholesterol (-32.0 +/- 35.1 mg/dL) and LDL-c levels (-28.7 +/- 32.7 mg/dL) in the treated group, the final levels being significantly lower than those of the placebo group (p = 0.008 and p = 0.020, respectively). The results obtained suggest that the treatment had a significant hypocholesterolemic effect, without influencing the anthropometric or calorimetric parameters tested.

  19. Laboratory evaluations of insecticide product efficacy for control of Cimex lectularius.

    PubMed

    Moore, David J; Miller, Dini M

    2006-12-01

    A susceptible, laboratory strain of bed bug, Cimex lectularius L., was used to determine the efficacy of insecticide products labeled or possessing a site label for bed bug control. Field strain bed bugs also were used to evaluate one insecticide product. The lethal time (LT),, values calculated for the laboratory strain bed bugs indicated that all of the pyrethroid products killed significantly faster than chlorfenapyr (0.5% [AIl; Phantom: BASF; LT50 = 10 d and 9 h). lamda-Cyhalothrin (0.03%; Demand CS; Syngenta) was the fastest acting insecticide (LT50 = 20 min), followed by bifenthrin (0.02% [AI]; Talstar One, FMC; LT50 = 53 min), deltamethrin (0.06% [AI]; Suspend SC; Bayer; LT50 = 61 min), and permethrin (0.05%; Dragnet SFR; FMC; LT50 = 88 min). The field strain bed bugs exposed to deltamethrin had an LT50 value of 14 day 8 h, indicating that the field strain was significantly less susceptible to deltamethrin than the laboratory strain. Chlorfenapyr exposure did not prevent the laboratory strain bed bugs from mating and laying eggs, nor did it prevent the eggs from hatching during the 2-wk exposure period. Surprisingly, none of the insecticides tested, including the pyrethroids, were repellent to laboratory strain bed bugs. Bed bugs rested on pyrethroid-treated panels and remained in contact with the panels until they died (2 h). Chlorfenapyr was also not repellent to bed bugs, but it caused no mortality during the 2-h test period. This study suggests that although pyrethroids were effective for controlling laboratory strain bed bugs, there is the potential for significant resistance in field strains. This study also determined that pyrethroid products were not repellent to bed bugs and would not cause bed bug aggregations to scatter or avoid treated surfaces.

  20. Evaluation of the relationship between elevated vancomycin trough concentrations and increased efficacy and/or toxicity.

    PubMed

    Ackerman, Bruce H; Guilday, Robert E; Reigart, Cynthia L; Patton, Mary L; Haith, Linwood R

    2013-01-01

    Isolation of Staphylococcus aureus with minimum inhibitory concentrations, 1 to 2 mg/L, suggests increasing vancomycin trough ranges, from 10 to 20 mg/L or even higher. Vancomycin troughs from 604 treatment courses from 560 patients with suspected or actual Gram-positive infection were analyzed with focus on potential toxicity/efficacy. Trough concentrations were required to be drawn within 15 to 45 minutes before the administration of at least the third vancomycin dose. Patients were retrospectively evaluated for their total daily dose and milligrams per kilograms per vancomycin dose. Data on the duration of vancomycin therapy, days to a normal temperature, and white blood cells were obtained. Data were stratified by trough concentration as <5, 5 to 10, and >10 mg/L to determine whether there was any relationship between response and trough concentration. Demographic data were obtained in 560 patients with 604 vancomycin treatment courses. For 361 patients with 379 separate treatment courses of vancomycin therapy no other nephrotoxic antimicrobial agent had been used. The greatest risk of vancomycin nephrotoxicity correlated with the duration of treatment. Using the log time to normal temperature, white blood cell count, heart rate, outcome from vancomycin therapy was assessed and no relationship could be demonstrated for the three vancomycin trough strata using analysis of variance (F < 2.62 for all parameters; p > .05). These data indicate that vancomycin trough elevation may not guarantee treatment success and that there may be no real benefit from higher vancomycin trough concentrations in thermal injury patients with burns <20% TBSA.

  1. Comparative efficacy evaluation of disinfectants routinely used in hospital practice: India

    PubMed Central

    Singh, Malkit; Sharma, Rahul; Gupta, Pramod K; Rana, Jatinder K; Sharma, Meera; Taneja, Neelam

    2012-01-01

    Aim: The aim of this study was to evaluate and compare practically achieved disinfection efficacy of some locally available disinfectants on surfaces and infectious microbiological hospital waste. Materials and Methods: Seven disinfectants were tested at concentrations recommended by manufacturers on rough and smooth surfaces that were contaminated experimentally by locally circulating isolates of methicillin-resistant Staphylococcus aureus, multidrug-resistant Acinetobacter baumannii, Klebsiella pneumoniae, Enterobacter aerogenes, Pseudomonas aeruginosa strains, standard isolate of Salmonella typhi and Candida albicans. Reduction in microbial counts before and after surface disinfection was expressed as log reduction. A very heavy microbial waste load was simulated by immersing culture plates with heavy microbial growth in disinfectants. Daily, a sample of disinfectant was taken and subjected to in-use test. Results: The highest average log reduction of test microbes on the rough surface was given by DesNet (5.05) and Bacillocid special (5.02). A comparable average log reduction of test microbes on a smooth steel surface was noted (5.68, 5.67, 5.50) for Lysol, Bacillocid sp. and DesNet, respectively. In the discard jars, Bacillocid special worked satisfactorily for 4 days, DesNet for 3 days and Hi-giene Germitol for 1 day. The remainder of the disinfectants failed in the in-use test on Day 1. Phenolics, although widely used in our settings, may not be as good surface disinfectants as newer formulations like DesNet and Bacillocid special. Conclusions: Newer quaternary ammonium compounds and aldehyde formulations were found to be the best disinfectants for disinfection of heavy contamination. PMID:23188950

  2. Evaluation of Polymerization Efficacy in Composite Resins via FT-IR Spectroscopy and Vickers Microhardness Test

    PubMed Central

    Jafarzadeh, Tahereh-Sadat; Erfan, Mohammad; Behroozibakhsh, Marjan; Fatemi, Mostafa; Masaeli, Reza; Rezaei, Yashar; Bagheri, Hossein; Erfan, Yasaman

    2015-01-01

    Background and aims. Polymerization efficacy affects the properties and performance of composite resin restorations.The purpose of this study was to evaluate the effectiveness of polymerization of two micro-hybrid, two nano-hybrid and one nano-filled ormocer-based composite resins, cured by two different light-curing systems, using Fourier transformation infrared (FT-IR) spectroscopy and Vickers microhardness testing at two different depths (top surface, 2 mm). Materials and methods. For FT-IR spectrometry, five cylindrical specimens (5mm in diameter × 2 mm in length) were prepared from each composite resin using Teflon molds and polymerized for 20 seconds. Then, 70-μm wafers were sectioned at the top surface and at2mm from the top surface. The degree of conversion for each sample was calculated using FT-IR spectroscopy. For Vickers micro-hardness testing, three cylindrical specimens were prepared from each composite resin and polymerized for 20 seconds. The Vickers microhardness test (Shimadzu, Type M, Japan) was performed at the top and bottom (depth=2 mm) surfaces of each specimen. Three-way ANOVA with independent variables and Tukey tests were performed at 95% significance level. Results. No significant differences were detected in degree of conversion and microhardness between LED and QTH light-curing units except for the ormocer-based specimen, CeramX, which exhibited significantly higher DC by LED. All the composite resins showed a significantly higher degree of conversion at the surface. Microhardness was not significantly affected by depth, except for Herculite XRV Ultra and CeramX, which showed higher values at the surface. Conclusion. Composite resins containing nano-particles generally exhibited more variations in degree of conversion and microhardness. PMID:26889359

  3. [THE USE OF THE MODEL MOUSE ICR--VARIOLA VIRUS FOR EVALUATION OF ANTIVIRAL DRUG EFFICACY].

    PubMed

    Titova, K A; Sergeev, Al A; Kabanov, A S; Bulychev, L E; Sergeev, Ar A; Galakhova, D O; Shishkina, L N; Zamedyanskaya, A S; Nesterov, A E; Glotov, A G; Taranov, O S; Omigov, V V; Agafonov, A P; Sergeev, A N

    2016-01-01

    Mice of the ICR outbred population were infected intranasally (i/n) with the variola virus (VARV, strain Ind-3a). Clinical signs of the disease did not appear even at the maximum possible dose of the virus 5.2 lg PFU/head (plaque-forming units per head). In this case, 50% infective dose (ID50) of VARV estimated by the presence or absence of the virus in the lungs three days after infection (p.i.) was equal to 2.7 ± 0.4 lg PFU/head. Taking into account the 10% application of the virus in the lungs during the intranasal infection of the mice, it was adequate to 1.7 lg PFU/lungs. This indicates a high infectivity of the VARV for mice comparable to its infectivity for humans. After the i/n infection of mice with the VARV at a dose 30 ID50/ head the highest concentration of the virus detected in the lungs (4.9 ± 0.0 lg PFU/ml of homogenate) and in nasal cavity tissues (4.8 ± 0.0 lg PFU/ml) were observed. The pathomorphological changes in the respiratory organs of the mice infected with the VARV appeared at 3-5 days p.i., and the VARV reproduction noted in the epithelial cells and macrophages were noticed. When the preparations ST-246 and NIOCH-14 were administered orally at a dose of 60 μg/g of mouse weight up to one day before infection, after 2 hours, 1 and 2 days p.i., the VARV reproduction in the lungs after 3 days p.i. decreased by an order of magnitude. Thus, outbred ICR mice infected with the VARV can be used as a laboratory model of the smallpox when evaluating the therapeutic and prophylactic efficacy of the antismallpox drugs.

  4. Evaluation of Polymerization Efficacy in Composite Resins via FT-IR Spectroscopy and Vickers Microhardness Test.

    PubMed

    Jafarzadeh, Tahereh-Sadat; Erfan, Mohammad; Behroozibakhsh, Marjan; Fatemi, Mostafa; Masaeli, Reza; Rezaei, Yashar; Bagheri, Hossein; Erfan, Yasaman

    2015-01-01

    Background and aims. Polymerization efficacy affects the properties and performance of composite resin restorations.The purpose of this study was to evaluate the effectiveness of polymerization of two micro-hybrid, two nano-hybrid and one nano-filled ormocer-based composite resins, cured by two different light-curing systems, using Fourier transformation infrared (FT-IR) spectroscopy and Vickers microhardness testing at two different depths (top surface, 2 mm). Materials and methods. For FT-IR spectrometry, five cylindrical specimens (5mm in diameter × 2 mm in length) were prepared from each composite resin using Teflon molds and polymerized for 20 seconds. Then, 70-μm wafers were sectioned at the top surface and at2mm from the top surface. The degree of conversion for each sample was calculated using FT-IR spectroscopy. For Vickers micro-hardness testing, three cylindrical specimens were prepared from each composite resin and polymerized for 20 seconds. The Vickers microhardness test (Shimadzu, Type M, Japan) was performed at the top and bottom (depth=2 mm) surfaces of each specimen. Three-way ANOVA with independent variables and Tukey tests were performed at 95% significance level. Results. No significant differences were detected in degree of conversion and microhardness between LED and QTH light-curing units except for the ormocer-based specimen, CeramX, which exhibited significantly higher DC by LED. All the composite resins showed a significantly higher degree of conversion at the surface. Microhardness was not significantly affected by depth, except for Herculite XRV Ultra and CeramX, which showed higher values at the surface. Conclusion. Composite resins containing nano-particles generally exhibited more variations in degree of conversion and microhardness.

  5. [Evaluating thrombolytic efficacy and thrombus targetability of RGDS-liposomes encapsulating subtilisin FS33 in vivo].

    PubMed

    Wang, Chengtao; Ji, Baoping; Cao, Yanping; Sun, Baoguo; Liu, Xudong

    2010-04-01

    A novel fibrinolytic enzyme subtilisin FS33, which exhibits much higher activity for decomposing fibrin than urokinase, was purified from Douchi, a traditional soybean-fermented food in China. In order to increase bio-utilization and thrombus targetability of subtilisin FS33 labeled by fluorescein isothiocyanate (FITC), the surface modified liposomes encapsulating subtilisin FS33 and FITC with a synthetic peptide Arg-Gly-Asp-Ser (RGDS), being putatively a specific antagonist of fibrinogen receptor on platelet membrane, were prepared and used to evaluate the therapeutic efficacy in a rat model thrombotic carotid artery. The arterial thrombosis was induced by applying two pieces of filter paper (1 x 2 cm) saturated with 10% of ferric chloride (FeCl3). The rats were infused via the jugular vein with either liposomes carrying BSA (control group) or RGDS-liposomes carrying subtilisin FS33 at doses of 2000 and 4000 U/kg. The plasma of the group infused with RGDS-liposomes showed higher antithrombotic and fibrinolytic activity than did the control group within 15-120 min after infusing. The higher the dose was gived, the higher the activity was shown. APTT(activiated partial thromboplastin time), PT (prothrombin time) and TT (thrombin time) were extended remarkably (P < 0.05, P < 0.01), and FDP (fibrinogen degradation products) also increased greatly (P < 0.01), while ELT (euglobulinlysis time) decreased obviously (P < 0.05). FITC content in heart and brain evidently increased (P < 0.05), and results of D-dimer test were all positive. In addition, the venous thrombi in brain and kidney were dissolved totally or partly as observed by patholgical section. All these indicated that subtilisin FS33 enhanced the antithrombotic and fibrinolytic activities in rat, and RGDS-liposomes improved, in a certain degree, the thrombolytic specificity for targeting to thrombus.

  6. Moxifloxacin pharmacokinetic profile and efficacy evaluation in empiric treatment of community-acquired pneumonia.

    PubMed

    Öbrink-Hansen, Kristina; Hardlei, Tore Forsingdal; Brock, Birgitte; Jensen-Fangel, Søren; Kragh Thomsen, Marianne; Petersen, Eskild; Kreilgaard, Mads

    2015-04-01

    When antimicrobials are used empirically, pathogen MICs equal to clinical breakpoints or epidemiological cutoff values must be considered. This is to ensure that the most resistant pathogen subpopulation is appropriately targeted to prevent emergence of resistance. Accordingly, we determined the pharmacokinetic (PK) profile of moxifloxacin at 400 mg/day in 18 patients treated empirically for community-acquired pneumonia. We developed a population pharmacokinetic model to assess the potential efficacy of moxifloxacin and to simulate the maximal MICs for which recommended pharmacokinetic-pharmacodynamic (PK-PD) estimates are obtained. Moxifloxacin plasma concentrations were determined the day after therapy initiation using ultra-high-performance liquid chromatography. Peak drug concentrations (Cmax) and area under the free drug concentration-time curve from 0 to 24 h (fAUC0-24) values predicted for each patient were evaluated against epidemiological cutoff MIC values for Streptococcus pneumoniae, Haemophilus influenzae, and Legionella pneumophila. PK-PD targets adopted were a Cmax/MIC of ≥12.2 for all pathogens, an fAUC0-24/MIC of >34 for S. pneumoniae, and an fAUC0-24/MIC of >75 for H. influenzae and L. pneumophila. Individual predicted estimates for Cmax/MIC and fAUC0-24/MIC as well as simulated maximal MICs resulting in target attainment for oral and intravenous administration of the drug were suitable for S. pneumoniae and H. influenzae but not for L. pneumophila. These results indicate that caution must be taken when moxifloxacin is used as monotherapy to treat community-acquired pneumonia caused by L. pneumophila. In conclusion, this report reveals key information relevant to the empirical treatment of community-acquired pneumonia while highlighting the robust and flexible nature of this population pharmacokinetic model to predict therapeutic success. (Clinical Trials Registration no. NCT01983839.).

  7. Pilot evaluation of the efficacy of shampoo treatment with ultrapure soft water for canine pruritus.

    PubMed

    Ohmori, Keitaro; Tanaka, Akane; Makita, Yuka; Takai, Masaki; Yoshinari, Yuji; Matsuda, Hiroshi

    2010-10-01

    Ultrapure soft water (UPSW) is water in which calcium and magnesium ions have been replaced with sodium ions using a cation-exchange resin. We recently demonstrated that washing with soap and UPSW reduced the clinical severity of dermatitis and improved the skin barrier function in NC/NgaTnd mice, a murine model for human atopic dermatitis. The purpose of this pilot study was to evaluate the efficacy of shampoo treatment with UPSW for dogs with pruritus. Eleven dogs with pruritus were randomly assigned to two groups depending on whether they received weekly shampoo treatment with UPSW or tap water for 4 weeks. After a washout period, the treatment protocol was switched such that each dog received both treatments. The pre-treatment and post-treatment values of the following were compared: pruritus scores assessed by the owners; dermatitis scores recorded by an investigator; and transepidermal water loss (TEWL). Shampoo treatment with UPSW significantly decreased pruritus and dermatitis scores in the dogs, whereas shampoo treatment with tap water did not. In addition, shampoo treatment with UPSW, but not with tap water, significantly reduced TEWL in the dogs. Adverse events due to the treatment were not observed in the dogs. Furthermore, we found that topical application of UPSW for barrier-disrupted skin caused by tape stripping in healthy dogs decreased TEWL more rapidly than topical application of tap water. Our findings suggest that shampoo treatment with UPSW promotes skin barrier recovery and thus could be considered as a possible therapeutic option in the management of pruritus and dermatitis in dogs.

  8. To Evaluate the Efficacy of an Innovative Irrigant on Smear Layer Removal – SEM Analysis

    PubMed Central

    Sukumaran, Vridhachalam Ganapathy; Subbiya, Arunajatesan

    2016-01-01

    Introduction The goal of endodontic therapy is to completely eliminate the microorganisms and the smear layer from the root canal in order to provide a good seal of the root filling materials. Aim The aim of this study was to find a viable alternative irrigant, which is easily available with less erosion and clinically acceptable smear layer removal by comparing the efficacy of EDTA and commercially available super-oxidized water, named Oxum, as a final rinse on smear layer removal and erosion in relation to coronal, middle and apical thirds of radicular dentin using Scanning Electron Microscope (SEM) analysis. Materials and Methods Freshly extracted 30 human lower second premolar teeth with straight roots and type I canal anatomy were selected. The root canals were cleaned and shaped using Universal Protaper Rotary System. Irrigation was performed with 1 ml of 2.5% of NaOCl solution after each instrument change. The final irrigation (5 ml) sequence was as follows: Group I- 17% EDTA, Group II – OXUM, and Group III - 0.9% saline (control) for one minute. Then, the root canals were finally irrigated with 5ml of distilled water to remove any precipitate. The roots were then gently split into two halves using a chisel and subjected to SEM analysis. Results The SEM photomicrographs were evaluated by two independent examiners and Mann Whitney results showed that there was no statistically significant difference between the two examiners. Non-parametric statistical analysis of all experimental groups showed significant difference between coronal, middle and apical third for smear layer removal with p-value<0.05. For erosion, in group II (oxum) showed statistically significant difference between coronal, middle and apical third and it showed significantly less dentine erosion when compared to EDTA. Conclusion Within the limitations of the present study, Oxum the commercially available super-oxidized water proved to be equally effective in smear layer removal with less

  9. MR Neurography and Diffusion Tensor Imaging: Origins, History & Clinical Impact of the first 50,000 cases with an Assessment of Efficacy and Utility in a Prospective 5,000 Patient Study Group

    PubMed Central

    Filler, Aaron

    2009-01-01

    Objective Methods were invented that made it possible to image peripheral nerves in the body and to image neural tracts in the brain. Over a 15 year period, these techniques – MR Neurography and Diffusion Tensor Imaging – were then deployed in the clinical and research community and applied to about 50,000 patients. Within this group, about 5,000 patients having MR Neurography were carefully tracked on a prospective basis. Method In the study group a uniform imaging methodology was applied and all images were reviewed and registered by referral source, clinical indication, efficacy of imaging and quality. Various classes of image findings were identified and subjected to a variety of small targeted prospective outcome studies. Those findings demonstrated to be clinically significant were then tracked in the larger clinical volume data set. Results MR Neurography demonstrates mechanical distortion of nerves, hyperintensity consistent with nerve irritation, nerve swelling, discontinuity, relations of nerves to masses, and image features revealing distortion of nerve at entrapment points. These findings are often clinically relevant and warrant full consideration in the diagnostic process. They result in specific pathologic diagnoses that are comparable to electrodiagnostic testing in clinical efficacy. Conclusions MR Neurography and DTI neural tract imaging have been validated as indispensable clinical diagnostic methods that provide reliable anatomical pathological information. There is no alternative diagnostic method in many situations. With the elapse of 15 years, tens of thousands of imaging studies, and hundreds of publications, these methods should no longer be considered experimental. PMID:19927075

  10. Long term follow-up concerning safety and efficacy of novel adhesion prophylactic agent for laparoscopic myomectomy in the prospective randomized ADBEE study.

    PubMed

    Cezar, Cristina; Tchartchian, Garri; Korell, Matthias; Ziegler, Nicole; Senshu, Kazuhisa; De Wilde, Maya Sophie; Herrmann, Anja; Larbig, Angelika; De Wilde, Rudy Leon

    2016-08-01

    We conducted a prospective randomized single blind - subject study in the University Clinic of Gynecology of Pius-Hospital Oldenburg. The primary objective of the ADBEE study was to assess the safety and manageability of ADBLOCK when used as an adjunct to laparoscopic surgery for the primary of myomas in women wishing to improve pregnancy outcomes. The study population included 32 women aged between 18-45 years, in good general health condition, who have not completed their family planning and who are undergoing primary ('virgin') laparoscopic myomectomy with an aim to improve pregnancy outcomes. The patients were randomized in 2 groups, ADBLOCK arm with 21 patients and surgery only arm with 11 patients. The study was single blind - subject and the investigators were blinded to treatment group assignment until completion of uterine suturing and prior to removal of the endoscope. A vigorous follow-up of subjects was organized, focusing on its two critical characteristics: completeness and duration. Completeness represented the percentage of subjects who returned to every planed follow - up appointments. The patients were evaluated in a specific period of time, which defined the duration of follow-up. Safety of the ADBLOCK was estimated after analyzing and documentation of any adverse events occurred, clinical and physical examination of patients as well as evaluation of laboratory measures. There were 25 adverse events reported in ADBLOCK treatment group and 12 events in NO-ADBLOCK group over the 24-months treatment. All adverse events in both treatment arms were not anticipated, with all events in the ADBLOCK group being resolved. At 28 days, there was no significant difference in proportion of events between the two treatments (p = 0.440). Overall, the number of events reported was low and the severity of events was generally mild with an unlikely or no relationship to treatment. There were no unanticipated device related adverse events seen in both treatment

  11. A 12-month single arm pilot study to evaluate the efficacy and safety of sirolimus in combination with tacrolimus in kidney transplant recipients at high immunologic risk.

    PubMed

    Lee, Juhan; Lee, Jung Jun; Kim, Beom Seok; Lee, Jae Geun; Huh, Kyu Ha; Park, Yongjung; Kim, Yu Seun

    2015-06-01

    The optimal immunosuppressive strategy for renal transplant recipients at high immunologic risk remains a topic of investigation. This prospective single arm pilot study was undertaken to evaluate the safety and efficacy of a combined tacrolimus and sirolimus regimen in recipients at immunological high risk and to compare outcomes with a contemporaneous control group received tacrolimus and mycophenolate mofetil. Patients that received a renal allograft between 2010 and 2011 at high risk (defined as panel reactive antibodies > 50%, 4 or more human leukocyte antigen mismatches, or retransplantation) were enrolled. All patients received basiliximab induction and corticosteroids. A total of 28 recipients treated with tacrolimus and sirolimus were enrolled in this study and 69 recipients were retrospectively reviewed as a control group. The sirolimus group showed a higher, but not statistically significant, incidence of biopsy proven acute rejection and a lower glomerular filtration rate than the control group. Furthermore, sirolimus group was associated with significant increases in BKV infection (P = 0.031), dyslipidemia (P = 0.004), and lymphocele (P = 0.020). The study was terminated prematurely due to a high incidence of adverse events. A de novo tacrolimus/sirolimus combination regimen may not be an ideal choice for recipients at high immunological risk.

  12. Evaluation of the efficacy and safety of Salvia officinalis in controlling hot flashes in prostate cancer patients treated with androgen deprivation.

    PubMed

    Vandecasteele, Katrien; Ost, Piet; Oosterlinck, Willem; Fonteyne, Valérie; Neve, Wilfried De; Meerleer, Gert De

    2012-02-01

    The purpose of this pilot study was to evaluate the efficacy and safety of Salvia officinalis in controlling hot flashes in prostate cancer patients treated with androgen deprivation therapy (ADT). Ten patients experiencing hot flashes were included in a single-centre prospective pilot study. Treatment consisted of 150 mg of Salvia officinalis extract taken orally three times daily. A diary questionnaire scoring hot flashes, subjective side effects and quality of life (QOL) had to be completed. Clinical examination was performed at every visit and the concentration of ADT-linked hormones, haemoglobin and cholesterol was measured before, during and after ending treatment. Before the start of treatment, a 1 week baseline registration was performed. An analysis of variance with time of measurement as a within-subject factor was performed. When analysing the hot flashes score, one patient was excluded due to insufficient diary notes. The mean weekly score declined from 112 (SD = 71) at baseline to 59 (SD = 54) at the end of treatment (p = 0.002). Hot flashes diminished significantly from the first week up to and including week 3. This was maintained during treatment. There was no effect on QOL. There were no side effects. It is concluded that Salvia officinalis is efficient and safe in the treatment hot flashes, without improving QOL.

  13. Psychometric evaluation of dietary self-efficacy and outcome expectation scales in female college freshmen.

    PubMed

    Kedem, Leia E; Evans, Ellen M; Chapman-Novakofski, Karen

    2014-11-01

    Lifestyle interventions commonly measure psychosocial beliefs as precursors to positive behavior change, but often overlook questionnaire validation. This can affect measurement accuracy if the survey has been developed for a different population, as differing behavioral influences may affect instrument validity. The present study aimed to explore psychometric properties of self-efficacy and outcome expectation scales-originally developed for younger children-in a population of female college freshmen (N = 268). Exploratory principal component analysis was used to investigate underlying data patterns and assess validity of previously published subscales. Composite scores for reliable subscales (Cronbach's α ≥ .70) were calculated to help characterize self-efficacy and outcome expectation beliefs in this population. The outcome expectation factor structure clearly comprised of positive (α = .81-.90) and negative outcomes (α = .63-.67). The self-efficacy factor structure included themes of motivation and effort (α = .75-.94), but items pertaining to hunger and availability cross-loaded often. Based on cross-loading patterns and low Cronbach's alpha values, respectively, self-efficacy items regarding barriers to healthy eating and negative outcome expectation items should be refined to improve reliability. Composite scores suggested that eating healthfully was associated with positive outcomes, but self-efficacy to do so was lower. Thus, dietary interventions for college students may be more successful by including skill-building activities to enhance self-efficacy and increase the likelihood of behavior change.

  14. Evaluation of efficacy and tolerability of RB Tone forte tablet in the treatment of pregnancy anaemia.

    PubMed

    Fadnavis, Rashmi; Faruqui, Arif A; Joshi, Chandrakant

    2011-02-01

    In India < 90% of anaemia cases are estimated to be due to iron deficiency, because high iron requirements during pregnancy are not easily fulfilled by dietary intake. Ferrous ascorbate is widely prescribed iron salt in India but still no trial of ferrous ascorbate in Indian patients has been published. The study is to aim the evaluation of efficacy and tolerability of RB Tone forte tablet in the treatment of pregnancy anaemia. Fifty-five pregnant women (> 18 years) with haemoglobin value between 8 and 11 g/dl in 13th week of pregnancy were included in the study. The duration of study was 6 months. Study drug RB Tone forte tablet, (Medley pharmaceutical, Mumbai) containing ferrous ascorbate equivalent to elemental iron 100 mg + folic acid 1.5 mg + elemental zinc 22.5 mg was prescribed once daily to all pregnant women from 13th week of pregnancy for a duration of 6 months. Haemoglobin was assessed at the beginning of the therapy and at the end of the trial. Study included birth weight and gestational age as outcomes because of a need for more information on the functional consequences of iron supplementation during pregnancy. Tolerability was evaluated based on the global assessment by the investigator and patients on a 3-point scale marked as excellent/good/poor. Fifty patients were included for final analysis, 5 patients lost to follow-up. Haemoglobin levels increased from the mean baseline value of 8.950 +/- 0.1422 g/dl to 11.91 +/- 0.07840 g/dl, with mean increase of 2.964 +/- 0.1624 g/dl at the end of trial (p < 0.0001). Mean birth weight of infants (n = 50) was found to be 3079 +/- 25.10 g. Mean gestational age at the time of delivery was 38 weeks. No preterm delivery was reported, As per investigators assessment about tolerability of trial drug, 48% of patients reported good, 46% excellent and 6% reported poor tolerability. As per patient's assessment about tolerability 92% of patients reported good to excellent tolerability and 8% reported poor tolerability

  15. GRS Method for Uncertainties Evaluation of Parameters in a Prospective Fast Reactor

    NASA Astrophysics Data System (ADS)

    Peregudov, A.; Andrianova, O.; Raskach, K.; Tsibulya, A.

    2014-04-01

    A number of recent studies have been devoted to the uncertainty estimation of reactor calculation parameters by the GRS (Generation Random Sampled) method. This method is based on direct sampling input data resulting in formation of random sets of input parameters which are used for multiple calculations. Once these calculations are performed, statistical processing of the calculation results is carried out to determine the mean value and the variance of each calculation parameter of interest. In our study this method is used to estimate the uncertainty of calculation parameters (keff, power density, dose rate) of a prospective sodium-cooled fast reactor. Neutron transport calculations were performed by the nodal diffusion code TRIGEX and Monte Carlo code MMK.

  16. Prospective Evaluation of Severe Skin Toxicity and Pain During Postmastectomy Radiation Therapy

    SciTech Connect

    Pignol, Jean-Philippe; Vu, Thi Trinh Thuc; Mitera, Gunita; Bosnic, Sandy; Verkooijen, Helena M.; Truong, Pauline

    2015-01-01

    Purpose: To prospectively capture acute toxicities and pain associated with postmastectomy radiation therapy (PMRT), to analyze patient and treatment risk factors for severe side effects. Methods and Materials: Women referred for PMRT were prospectively enrolled and assessed weekly during and after radiation therapy. The endpoint included severe National Cancer Institute Common Terminology Criteria for Adverse Effects grade 3 moist desquamation, other skin symptoms, and pain. Results: Of 257 patients, 73 (28.4%) experienced extensive moist desquamation, 84 (32.7%) Common Terminology Criteria for Adverse Effects skin toxicity grade 3, and 57 (22.2%) a pain impacting on daily life activities. Among symptoms only grade 3 moist desquamation was significantly associated with severe pain (P<.001). On multivariate analysis, smoking, high-energy photons, and skin bolus were significantly associated with severe moist desquamation. Skin toxicity doubled for smokers, with 40% severe pain, 48% grade 3 moist desquamation, and 64% grade 3 skin toxicity. Without skin bolus 4.2% had severe pain, none moist desquamation, and 2.1% grade 3 skin toxicity. When skin bolus was used on alternate days, the frequency increased to 15% for pain, 22% for moist desquamation, and 26% for grade 3 skin toxicity. When bolus was used daily, 32% had pain, 41% moist desquamation, and 47% grade 3 skin toxicity. Symptoms peaked 1 to 2 weeks after the end of PMRT. Conclusions: The present cohort study suggests excessive radiation toxicity after PMRT. Among factors associated with an increase of toxicity are smoking habits and the use of skin bolus.

  17. Prospective evaluation of an in-center daily hemodialysis program: results of two years of treatment.

    PubMed

    André, Mauro B; Rembold, Simone M; Pereira, Claudia M; Lugon, Jocemir R

    2002-01-01

    Short duration daily hemodialysis (DHD) emerges as a well-tolerated alternative to standard hemodialysis (SHD). In this prospective study 5 patients in SHD were recruited to participate in an in-center DHD program. The SHD consisted of 3 sessions of 4 h each per week. Nonproportional mixture machines without an ultrafiltration control device and low flow dialyzers were used. For DHD, dialysis equipment and procedures were kept the same. Dialysis sessions, however, began at 6 p.m. (from Monday to Saturday) and lasted 2 h. Data from the last 6 months on SHD of the same patients were compared with the ones from each semester on DHD. Bone biopsy was performed at start and at the end of the 2-year study period. Hypotensive episodes, hypertensive crisis, cramps and headaches became 7-10 times less frequent in daily dialysis. A significant fractional increase ( approximately 12%) was seen in mean values for hematocrit. Predialysis urea levels as well as predialysis creatinine levels declined significantly. Also lower during the daily dialysis period were the mean values for both phosphorus and CaxP product. Significant increases were found in serum bicarbonate, albumin and in dry weight. The frequency of mean blood pressure >/=110 mm Hg on arrival for dialysis was significantly lower in every semester on daily hemodialysis. A significant twofold improvement in quality of life scoring was observed. Finally, daily hemodialysis also seemed to be beneficial to low turnover bone disease and bone aluminum deposition. These beneficial effects occurred despite of an increase in the frequency of missing days. Results from the present study which prospectively addressed the role of in-center short daily hemodialysis in the management of ESRD are encouraging.

  18. Evaluation of total alloplastic temporo-mandibular joint replacement with two different types of prostheses: A three-year prospective study

    PubMed Central

    Gonzalez-Perez-Somarriba, Borja; Centeno, Gabriel; Vallellano, Carpóforo; Montes-Carmona, Jose-Francisco

    2016-01-01

    Background Temporo-Mandibular Joint (TMJ) replacement has been used clinically for years. The objective of this study was to evaluate outcomes achieved in patients with two different categories of TMJ prostheses. Material and Methods All patients who had a TMJ replacement (TMJR) implanted during the study period from 2006 through 2012 were included in this 3-year prospective study. All procedures were performed using the Biomet Microfixation TMJ Replacement System, and all involved replacing both the skull base component (glenoid fossa) and the mandibular condyle. Results Fifty-seven patients (38 females and 19 males), involving 75 TMJs with severe disease requiring reconstruction (39 unilateral, 18 bilateral) were operated on consecutively, and 68 stock prostheses and 7 custom-made prostheses were implanted. The mean age at surgery was 52.6±11.5 years in the stock group and 51.8±11.7 years in the custom-made group. In the stock group, after three years of TMJR, results showed a reduction in pain intensity from 6.4±1.4 to 1.6±1.2 (p<0.001), and an improvement in jaw opening from 2.7±0.9 cm to 4.2±0.7 cm (p<0.001). In the custom-made group, after three years of TMJR, results showed a reduction in pain intensity from 6.0±1.6 to 2.2±0.4 (p<0.001), and an improvement in jaw opening from 1.5±0.5 cm to 4.3±0.6 cm (p<0.001). No statistically significant differences between two groups were detected. Conclusions The results of this three-year prospective study support the surgical placement of TMJ prostheses (stock prosthetic, and custom-made systems), and show that the approach is efficacious and safe, reduces pain, and improves maximum mouth opening movement, with few complications. As such, TMJR represents a viable technique and a stable long-term solution for cranio-mandibular reconstruction in patients with irreversible end-stage TMJ disease. Comparing stock and custom-made groups, no statistically significant differences were detected with respect to pain

  19. Prospective Evaluation of a Model-Based Dosing Regimen for Amikacin in Preterm and Term Neonates in Clinical Practice

    PubMed Central

    De Cock, R. F. W.; Allegaert, K.; Vanhaesebrouck, S.; Danhof, M.; Knibbe, C. A. J.

    2015-01-01

    Based on a previously derived population pharmacokinetic model, a novel neonatal amikacin dosing regimen was developed. The aim of the current study was to prospectively evaluate this dosing regimen. First, early (before and after second dose) therapeutic drug monitoring (TDM) observations were evaluated for achieving target trough (<3 mg/liter) and peak (>24 mg/liter) levels. Second, all observed TDM concentrations were compared with model-predicted concentrations, whereby the results of a normalized prediction distribution error (NPDE) were considered. Subsequently, Monte Carlo simulations were performed. Finally, remaining causes limiting amikacin predictability (i.e., prescription errors and disease characteristics of outliers) were explored. In 579 neonates (median birth body weight, 2,285 [range, 420 to 4,850] g; postnatal age 2 days [range, 1 to 30 days]; gestational age, 34 weeks [range, 24 to 41 weeks]), 90.5% of the observed early peak levels reached 24 mg/liter, and 60.2% of the trough levels were <3 mg/liter (93.4% ≤5 mg/liter). Observations were accurately predicted by the model without bias, which was confirmed by the NPDE. Monte Carlo simulations showed that peak concentrations of >24 mg/liter were reached at steady state in almost all patients. Trough values of <3 mg/liter at steady state were documented in 78% to 100% and 45% to 96% of simulated cases with and without ibuprofen coadministration, respectively; suboptimal trough levels were found in patients with postnatal age <14 days and current weight of >2,000 g. Prospective evaluation of a model-based neonatal amikacin dosing regimen resulted in optimized peak and trough concentrations in almost all patients. Slightly adapted dosing for patient subgroups with suboptimal trough levels was proposed. This model-based approach improves neonatal dosing individualization. PMID:26248375

  20. Randomized noninferiority study evaluating the efficacy of 2 commercial dry cow mastitis formulations.

    PubMed

    Johnson, A P; Godden, S M; Royster, E; Zuidhof, S; Miller, B; Sorg, J

    2016-01-01

    mastitis (DC=17.0%, SM=15.3%), or on risk for removal from the herd (DC=10.7%, SM=10.3%) between dry off and 100 DIM. Finally, multivariable linear regression with repeated measures showed no overall no difference between treatments in DHIA test-day somatic cell count linear score (DC=2.19, SM=2.22), butterfat test (DC=3.84%, SM=3.86%), protein test (DC=3.02%, SM=3.02%), or 305-d mature-equivalent milk production (DC=11,817 kg, SM=11,932 kg) between calving and 100 DIM. In conclusion, DC was noninferior to SM in effecting a cure, and there was no difference in efficacy between these 2 DCT formulations as related to all other udder health or cow performance measures evaluated between dry off and 100 DIM.

  1. Efficacy and tolerability of escitalopram in treatment of major depressive disorder with anxiety symptoms: a 24-week, open-label, prospective study in Chinese population

    PubMed Central

    Jiang, Kaida; Li, Lingjiang; Wang, Xueyi; Fang, Maosheng; Shi, Jianfei; Cao, Qiuyun; He, Jincai; Wang, Jinan; Tan, Weihao; Hu, Cuili

    2017-01-01

    Background Significant anxiety symptoms are associated with poor clinical course and outcome in major depressive disorder (MDD). This single-arm, open-label study aimed to evaluate the efficacy and tolerability of escitalopram treatment in patients with MDD and anxiety symptoms. Methods Adult patients with MDD and anxiety symptoms (Montgomery–Asberg Depression Rating Scale [MADRS] ≥22 and Hamilton Anxiety Rating Scale [HAM-A] ≥14) were enrolled and received escitalopram (10–20 mg/day) treatment for 24 weeks. Symptom status was assessed by MADRS, 17-item-Hamilton Depression Rating Scale, HAM-A, and Clinical Global Impression Scale at baseline and the following visits. Quality of life was assessed by Short Form-12, and safety was evaluated by adverse events, laboratory investigations, vital signs, and physical findings. Results Overall, 200 of 318 (66.2%) enrolled patients completed the 24-week treatment. The remission (MADRS ≤10 and HAM-A ≤7) rate in the full analysis set (N=285) was 73.3% (95% confidence interval: 67.80, 78.38) at week 24. Mean (± standard deviation) MADRS total score was 33.4 (±7.13) and HAM-A score was 27.6 (±7.26) at baseline, which reduced to 6.6 (±10.18) and 6.0 (±8.39), respectively, at week 24. Patients with higher baseline depression and anxiety level took longer to achieve similar remission rates. Overall, 80 of the 302 (26.5%) patients included in the safety set reported at least 1 treatment-emergent adverse event (TEAE). Most frequently reported TEAEs (>2%) were headache (4.0%), nasopharyngitis (3.6%), nausea (3.0%), and dizziness (2.6%). Serious TEAEs were reported by 1.3% patients; no deaths were reported. Conclusion Escitalopram 10–20 mg/day was effective and well-tolerated in the long-term treatment of MDD with anxiety symptoms in adult Chinese population. PMID:28255239

  2. Is it really clean? An evaluation of the efficacy of four methods for determining hospital cleanliness.

    PubMed

    Sherlock, O; O'Connell, N; Creamer, E; Humphreys, H

    2009-06-01

    An important component of effective cleaning in hospitals involves monitoring the efficacy of the methods used. Generally the recommended tool for monitoring cleaning efficacy is visual assessments. In this study four methods to determine cleaning efficacy of hospital surfaces were compared, namely visual assessment, chemical (ATP) and microbiological methods, i.e. aerobic colony count (ACC) and the presence of meticillin-resistant Staphylococcus aureus. Respectively, 93.3%, 71.5%, 92.1% and 95.0% of visual, ATP, ACC and MRSA assessments were considered acceptable or 'clean' according to each test standard. Visual assessment alone did not always provide a meaningful measure of surface cleanliness or cleaning efficacy. The average ATP value from 120 swabs before cleaning was 612 relative light units (RLU) (range: 72-2575) and 375 RLU after cleaning (range: 106-1071); the accepted standard is 500 RLU. In a hospital setting with low microbiological counts, the use of chemical tests such as ATP may provide additional information of cleaning efficacy and ATP trends allow identification of environmental surfaces that require additional cleaning or cleaning schedule amendments.

  3. Evaluating undergraduate nursing students' self-efficacy and competence in writing: Effects of a writing intensive intervention.

    PubMed

    Miller, Louise C; Russell, Cynthia L; Cheng, An-Lin; Skarbek, Anita J

    2015-05-01

    While professional nurses are expected to communicate clearly, these skills are often not explicitly taught in undergraduate nursing education. In this research study, writing self-efficacy and writing competency were evaluated in 52 nontraditional undergraduate baccalaureate completion students in two distance-mediated 16-week capstone courses. The intervention group (n = 44) experienced various genres and modalities of written assignments set in the context of evidence-based nursing practice; the comparison group (n = 8) received usual writing undergraduate curriculum instruction. Self-efficacy, measured by the Post Secondary Writerly Self-Efficacy Scale, indicated significant improvements for all self-efficacy items (all p's = 0.00). Writing competency, assessed in the intervention group using a primary trait scoring rubric (6 + 1 Trait Writing Model(®) of Instruction and Assessment), found significant differences in competency improvement on five of seven items. This pilot study demonstrated writing skills can improve in nontraditional undergraduate students with guided instruction. Further investigation with larger, culturally diverse samples is indicated to validate these results.

  4. Evaluation of Bt Corn with Pyramided Genes on Efficacy and Insect Resistance Management for the Asian Corn Borer in China

    PubMed Central

    Bai, Shuxiong; Wang, Zhenying; He, Kanglai

    2016-01-01

    A Bt corn hybrid (AcIe) with two Bt genes (cry1Ie and cry1Ac) was derived by breeding stack from line expressing Cry1Ie and a line expressing Cry1Ac. Efficacy of this pyramided Bt corn hybrid against the Asian corn borer (ACB), Ostrinia furnacalis, was evaluated. We conducted laboratory bioassays using susceptible and resistant ACB strains fed on artificial diet or fresh plant tissues. We also conducted field trials with artificial infestations of ACB neonates at the V6 and silk stages. The toxin-diet bioassay data indicated that mixtures of Cry1Ac and Cry1Ie proteins had synergistic insecticidal efficacy. The plant tissue bioassay data indicated that Bt corn hybrids expressing either a single toxin (Cry1Ac or Cry1Ie) or two toxins had high efficacy against susceptible ACB. Damage ratings in the field trials indicated that the Bt corn hybrids could effectively protect against 1st and the 2nd generation ACB in China. The hybrid line with two Bt genes showed a higher efficacy against ACB larvae resistant to Cry1Ac or CryIe than the hybrid containing one Bt gene, and the two gene hybrid would have increased potential for managing or delaying the evolution of ACB resistance to Bt corn plants. PMID:28006032

  5. Evaluation of Antimicrobial and Antifungal Efficacy of Inter Appointment Intracanal Medicaments against Enterococcus and Candida albicans: An In Vitro Study

    PubMed Central

    Gupta, Shubh Prabhat; Bhati, Manisha; Jhajharia, Kapil; Patel, Hardik; Paliwal, Ashutosh; Franklin, Sundeep

    2015-01-01

    Background: Microorganisms and their by-products in pulpal and periapical diseases are to be considered as the primary etiological agents of the pulpal necrosis and apical periodontitis. Enterococcus faecalis, which is the most common organism isolated from failed root canals, is a Gram-positive facultative anaerobe. Yeasts can be detected in 7-18% of infected root canals. Materials and Methods: Designed to evaluate the antimicrobial and antifungal efficacy of chlorhexidine gutta-percha (CHX-GP), and calcium hydroxide GP points against E. faecalis and Candida albicans. The test materials used are divided into 3 groups; Group A - Control, Regular GP, Group B – CHX-GP, Group C - Calcium hydroxide GP. Detail Method is explained in the article. Results: There was a significant difference in the inhibition of E. faecalis, in different materials at each time interval period (P < 0.05). Similarly, the inhibition of C. albicans in the different materials at each time period was found to be statistically significant (P < 0.05). Calcium hydroxide GP did not exhibit any antimicrobial effect on any of tested microorganisms for all the time periods. Conclusion: CHX-GP had the maximum effect on the test microorganisms, with the maximum efficacy on E. faecalis followed by C. albicans. Regular GP also had a significant efficacy on test microorganisms, with the maximum efficacy on E. faecalis followed by C. albicans. Calcium hydroxide GP did not have any effect on any test microorganisms during the entire test periods. PMID:26124609

  6. Evaluation of miglustat as maintenance therapy after enzyme therapy in adults with stable type 1 Gaucher disease: a prospective, open-label non-inferiority study

    PubMed Central

    2012-01-01

    Background Previous studies have provided equivocal data on the use of miglustat as maintenance therapy in Gaucher disease type 1. We report findings from a clinical trial evaluating the effects of miglustat treatment in patients with stable type 1 Gaucher disease after enzyme therapy. Methods Adult type 1 Gaucher disease patients stabilized during at least 3 years of previous enzyme therapy were included in this 2-year, prospective, open-label non-inferiority study. The primary endpoint was percent change from baseline in liver volume. Secondary endpoints included changes in spleen volume, hemoglobin concentration and platelet count. Results Forty-two patients were enrolled (mean±SD age, 45.1±12.7 years; previous enzyme therapy duration 9.5±4.0 years). Median (range) exposure to miglustat 100 mg t.i.d. was 658 (3–765) days. Twenty-one patients discontinued treatment prematurely; 13 due to adverse events, principally gastrointestinal. The upper 95% confidence limit of mean percent change in liver volume from baseline to end of treatment was below the non-inferiority margin of 10% (–1.1%; 95%CI −6.0, 3.9%). Mean (95%CI) changes in spleen volume, hemoglobin concentration and platelet count were 102 (24,180) mL, –0.95 (−1.38, –0.53) g/dL and −44.1 (–57.6, –30.7) ×109/L, respectively. Conclusions The primary efficacy endpoint was met; overall there was no change in liver volume during 24 months of miglustat therapy. Several patients showed a gradual deterioration in some disease manifestations, suggesting that miglustat could maintain clinical stability, but not in all patients. Miglustat demonstrated a predictable profile of safety and tolerability that was consistent with that reported in previous clinical trials and experience in clinical practice. Trial registration Clinicaltrials.gov identifier NCT00319046 PMID:23270487

  7. Methods for the evaluation of the protective efficacy of sunscreen products.

    PubMed

    Vergou, T; Patzelt, A; Schanzer, S; Meinke, M C; Weigmann, H-J; Thiede, G; Sterry, W; Lademann, J; Darvin, M E

    2013-01-01

    The objective of the present investigation was to examine the utilization of optical and spectroscopic methods for the noninvasive characterization of Anthelios XL Fluide Extreme (SPF 50+), an exemplary sunscreen, concerning its homogeneity of distribution on the skin, its spectroscopic properties and its overall protective efficacy. The homogeneity of the distribution of the sunscreen on the skin was investigated with a multiphoton tomography microscope. Additionally, the sum transmission spectrum was determined using tape stripping and spectroscopic measurements. The results revealed a very homogeneous distribution of the sunscreen on the skin surface and also in the deep furrows. The sum transmission spectrum reflects a high protective efficacy of the sunscreen in both the UVA and UVB ranges. The sunscreen Anthelios XL Fluide Extreme (SPF 50+) generates a comfortable feeling on the skin and can be easily distributed. The presented optical methods have been shown to be suitable to investigate the overall protective efficacy of sunscreen products objectively, noninvasively and quickly.

  8. siRNA-loaded cationic liposomes for cancer therapy: Development, characterization and efficacy evaluation

    NASA Astrophysics Data System (ADS)

    Ying, Bo

    . Pegylated cationic liposomes (PCLs) were selected as carriers for siRNA. Based on the silencing efficiency of siRNA formulated with different PCLs, DOPC based cationic liposomes, over DOPE based nanosystems, with a modest amount of polyetheleneglycol was selected to deliver KSP siRNA to tumor-bearing mice. Efficacy studies revealed that tumor suppression was observed when KSP siRNA was delivered using PCLs, but not in mice that received naked KSP siRNA or KSP siRNA in commercially available transfecting agents. The results were further supported by MRI (magnetic resonance imaging) analysis. To evaluate the role that vasculature supply plays in the development of the tumor, we also performed tumor response studies using a tumor model consisting of tumor cells which are resistant to KSP siRNA. The results showed that a prolonged suppression of tumor growth was achieved only when a large dose (5mg/kg) KSP siRNA was administered, but not with the administration of a relatively low dose (2mg/kg) of siRNA, suggesting that a combined treatment approach containing both anti-vasculature and anti-cancer agents should be considered to achieve the best treatment outcome. Finally, it was confirmed by qRT-PCR that the tumor growth inhibition was due to the successful knock-down of KSP mRNA.

  9. Evaluation of Daptomycin Exposure and Efficacy and Safety Endpoints To Support Risk-versus-Benefit Considerations.

    PubMed

    Bhavnani, Sujata M; Ambrose, Paul G; Hammel, Jeffrey P; Rubino, Christopher M; Drusano, George L

    2015-12-28

    The choice of an antimicrobial agent must balance optimization of efficacy endpoints with the minimization of safety events. The risk versus benefit of daptomycin for patients with Staphylococcus aureus bacteremia with or without infective endocarditis receiving daptomycin at 6, 8, and 10 mg/kg of body weight/day was assessed. The relationships between the area under the concentration-time curve over 24 h (AUC)/MIC ratio and both clinical response and time to decreased susceptibility were evaluated using data from patients with such infections who received daptomycin at 6 mg/kg/day. Using these relationships, plus the previously identified relationship between the minimum concentration and an elevation in the creatine phosphokinase (CPK) concentration (CPK elevation) (S. M. Bhavnani, C. M. Rubino, P. G. Ambrose, and G. L. Drusano, Clin Infect Dis 50:1568-1574, 2010) and Monte Carlo simulation, the probability of each outcome by MIC for daptomycin at 6, 8, and 10 mg/kg/day was calculated. The function for exposure-response relationships for clinical response (P = 0.06) and time to decreased susceptibility (P = 0.01) resembled U and inverted U shapes, respectively. Multivariable analyses demonstrated AUC/MIC ratio, creatinine clearance, albumin concentration, and disease category to be predictors of clinical response. The results of simulations failed to demonstrate large improvements in the probabilities of clinical success among cohorts of simulated patients defined by the above-described predictive factors or the probability of decreased susceptibility at 30 days when the daptomycin dose was increased from 6 to 10 mg/kg/day. The probability of CPK elevation increased from 0.073 to 0.156 over this dose range. These data can be used to inform risk-versus-benefit decisions for daptomycin dose selection in patients with S. aureus bacteremia with or without infective endocarditis. The risk of CPK elevation, which is reversible, should be weighed in the context of the

  10. Open, multicenter study to evaluate the tolerability and efficacy of Echinaforce Forte tablets in athletes.

    PubMed

    Schoop, Ronald; Büechi, Samuel; Suter, Andy

    2006-01-01

    This open, multicenter study investigated the tolerability and efficacy of a new tablet formulation of Echinacea purpurea extract (Echinaforce Forte; A. Vogel, Bioforce AG, Roggwil, Switzerland) in 80 subjects actively involved in sports. Most investigators (97.5%) rated the treatment as having "very good" or "good" tolerability. About 75% of patients and investigators rated its efficacy during a common cold as "very good" or "good," and 71% of subjects were free of cold episodes. This study is the first to suggest that Echinaforce is effective in the prophylaxis, as well as the treatment, of the common cold in persons who actively participate in sports.

  11. Design and prospective evaluation of a risk-based surveillance system for shrimp grow-out farms in northeast Brazil.

    PubMed

    Marques, Ana Rita; Pereira, Marcelo; Ferreira Neto, Jose Soares; Ferreira, Fernando

    2015-12-01

    The farming of Pacific white shrimp Litopennaeus vannamei in northeast Brazil, has proven to be a promising sector. However, the farming of Pacific white shrimp in Brazil has been affected negatively by the occurrence of viral diseases, threatening this sector's expansion and sustainability. For this reason, the drafting of a surveillance system for early detection and definition of freedom from viral diseases, whose occurrence could result in high economic loses, is of the utmost importance. The stochastic model AquaVigil was implemented to prospectively evaluate different surveillance strategies to determine freedom from disease and identify the strategy with the lowest sampling efforts, making the best use of available resources through risk-based surveillance. The worked example presented was designed for regional application for the state of Ceará and can easily be applied to other Brazilian states. The AquaVigil model can analyse any risk-based surveillance system that considers a similar outline to the strategy here presented.

  12. The self-evaluation of Slovenian prospective chemistry teachers' progress during their practical pedagogical training in primary schools.

    PubMed

    Wissiak Grm, Katarina S; Savec, Vesna Ferk

    2014-01-01

    The present research deals with the self-evaluation of prospective chemistry teachers' progress during their practical pedagogical training (PPT) in primary schools. The sample consisted of 42 students from the 3rd and 4th years of the undergraduate programmes "Chemistry and Biology" or "Chemistry and Physics" at the Faculty of Education, University of Ljubljana. For the purpose of the investigation, the students completed questionnaires after each day of their practical pedagogical training, and at the end the entire training wrote reflective essays about their most significant experiences. Analysis of the results reveals that the students believe that practical pedagogical training makes a crucial contribution to their practical pedagogical education in the light of their future profession. The students also reported on their progress concerning the various skills that were developed.

  13. An Evaluation of Teachers' Attitudes and Beliefs Levels on Classroom Control in Terms of Teachers' Sense of Efficacy (The Sample of Biology Teachers in Turkey)

    ERIC Educational Resources Information Center

    Kurt, Hakan

    2014-01-01

    The aim of this study is to evaluate biology teachers' attitudes and belief levels on classroom control in terms of teachers' sense of efficacy. The screening model was used in the study. The study group was comprised of 135 biology teachers. In this study, Teachers' Sense of Efficacy Scale (TSES) and The Attitudes and Beliefs on Classroom Control…

  14. A proposed wind measurement and analysis approach for evaluating a prospective wind plant site

    NASA Astrophysics Data System (ADS)

    Wendell, L. L.; Barnard, J. C.; Morris, V. R.

    1994-05-01

    On the basis of research results, cooperative efforts with wind energy developers, and work with meteorological consultants, Pacific Northwest Laboratory (PNL) has proposed an approach for performing wind measurement assessments for prospective wind plant sites. The primary goal of this approach is to effectively balance comprehensiveness with expense. The approach begins with the acquisition of high-resolution digital terrain data for the site. These data are used in computational and visual analyses to determine the best locations for a reference tower and several satellite towers used for wind measurements. The reference tower has wind sensors at three levels: 20, 30, and 40 m. The satellite towers have one sensor at 30 m. The sensors measure the vertical wind speed as well as the horizontal speed and direction. The sampling rate must be at least 4 times per second. The data acquisition system keeps track of turbulence statistics that are saved at intervals from ten minutes to one hour. Statistics for the 30-m level at the satellite towers, as well as the reference tower, provide the mean and variance of the total speed and covariances of the component speeds. The data base produced by this approach over 1-2 years should be valuable for both routine and in-depth analyses. This approach takes advantage of some recent technological developments. It is not being proposed as a standard at this time, but as a tool to be refined with experience.

  15. Prospective evaluation of renal allograft dysfunction with 99mtechnetium-diethylenetriaminepentaacetic acid renal scans

    SciTech Connect

    McConnell, J.D.; Sagalowsky, A.I.; Lewis, S.E.; Gailiunas, P.; Helderman, J.H.; Dawidson, I.; Peters, P.C.

    1984-05-01

    A prospective, single-blinded study was done to determine the ability of serial 99mtechnetium-diethylenetriaminepentaacetic acid scans to diagnose renal allograft rejection. Among 28 transplant recipients 111 renal scans were obtained 1 day postoperatively and every 3 to 4 days thereafter for 3 weeks in all patients retaining an allograft. Computer-generated time-activity blood flow curves were analyzed semiquantitatively for the 1) interval between curve peaks of the allograft and iliac artery, 2) renal transit time and 3) renal washout of radionuclide. Excretory function was assessed by degree and interval to appearance of radionuclide in the calices and bladder. Deterioration of renal blood flow and excretion compared to the initial scan was considered rejection. Of 52 scans performed during clinical rejection 47 (90.4 per cent) were interpreted as showing rejection (sensitivity). Of 53 scans interpreted as showing rejection 47 (88.7 per cent) were positive for clinical rejection. The remaining 6 patients (initial false positive results) suffered clinical rejection within 24 to 72 hours. We conclude that 99mtechnetium-diethylenetriaminepentaacetic acid renal scans are useful in the differential diagnosis of renal allograft dysfunction.

  16. Prospective, Multi-Center Evaluation of the Beckman Coulter Prostate Health Index Using WHO Calibration

    PubMed Central

    Loeb, Stacy; Sokoll, Lori J.; Broyles, Dennis L.; Bangma, Chris H.; van Schaik, Ron H.N.; Klee, George G.; Wei, John T.; Sanda, Martin G.; Partin, Alan W.; Slawin, Kevin M.; Marks, Leonard S.; Mizrahi, Isaac A.; Shin, Sanghyuk S.; Cruz, Amabelle B.; Chan, Daniel W.; Roberts, William L.; Catalona, William J.

    2014-01-01

    Purpose Reported prostate-specific antigen (PSA) values may differ substantially between assays with the Hybritech and World Health Organization (WHO) standardization. [-2]proPSA (p2PSA) and the Beckman Coulter prostate health index (phi) are newly approved serum markers, which are associated with prostate cancer risk and aggressiveness. Our objective was to study the influence of assay standardization on these markers. Materials and Methods PSA, % free PSA (%fPSA), and p2PSA were measured using the Hybritech calibration in 892 men undergoing prostate biopsy from a prospective multicenter study. Phi was calculated as: [p2PSA/ fPSA) × (square root of PSA)]. Performance characteristics of phi for prostate cancer detection were then determined using re-calculated WHO calibration PSA values. Results The median phi was significantly higher in men with prostate cancer compared to those with negative biopsies using the WHO values (47.4 vs 39.8, p<0.001). Phi offered improved discrimination of prostate cancer detection on biopsy (AUC 0.704) compared to %fPSA or total PSA using the WHO calibration. Conclusions Phi can be calculated using Hybritech or WHO standardized assays, and significantly improved the prediction of biopsy outcome over %fPSA or PSA alone. PMID:23206426

  17. Prospective Cohort Study Evaluating the Prognostic Value of Simple EEG Parameters in Postanoxic Coma.

    PubMed

    Azabou, Eric; Fischer, Catherine; Mauguiere, François; Vaugier, Isabelle; Annane, Djillali; Sharshar, Tarek; Lofaso, Fréderic

    2016-01-01

    We prospectively studied early bedside standard EEG characteristics in 61 acute postanoxic coma patients. Five simple EEG features, namely, isoelectric, discontinuous, nonreactive to intense auditory and nociceptive stimuli, dominant delta frequency, and occurrence of paroxysms were classified yes or no. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the receiver operating characteristic curve (AUC) of each of these variables for predicting an unfavorable outcome, defined as death, persistent vegetative state, minimally conscious state, or severe neurological disability, as assessed 1 year after coma onset were computed as well as Synek's score. The outcome was unfavorable in 56 (91.8%) patients. Sensitivity, specificity, PPV, NPV, and AUC of nonreactive EEG for predicting an unfavorable outcome were 84%, 80%, 98%, 31%, and 0.82, respectively; and were all very close to the ones of Synek score>3, which were 82%, 80%, 98%, 29%, and 0.81, respectively. Specificities for predicting an unfavorable outcome were 100% for isoelectric, discontinuous, or dominant delta activity EEG. These 3 last features were constantly associated to unfavorable outcome. Absent EEG reactivity strongly predicted an unfavorable outcome in postanoxic coma, and performed as accurate as a Synek score>3. Analyzing characteristics of some simple EEG features may easily help nonneurophysiologist physicians to investigate prognostic issue of postanoxic coma patient. In this study (a) discontinuous, isoelectric, or delta-dominant EEG were constantly associated with unfavorable outcome and (b) nonreactive EEG performed prognostic as accurate as a Synek score>3.

  18. Evaluation of the efficacy of emodepside plus praziquantel topical solution against ascarid infections (Toxocara cati or Toxascaris leonina) in cats.

    PubMed

    Reinemeyer, C R; Charles, S D; Buch, J; Settje, T; Altreuther, G; Cruthers, L; McCall, J W; Young, D R; Epe, C

    2005-10-01

    Eleven controlled studies were conducted in the United States and Europe to evaluate the efficacy of a topical solution of emodepside (3 mg/kg)+praziquantel (12 mg/kg) (Profender, Bayer AG, Leverkusen, Germany) against infection with various stages of the ascarid nematodes Toxocara cati and Toxascaris leonina. Infections were induced by administration of larvated ascarid eggs, and stage-specific efficacy was evaluated by treating cats at scheduled intervals post-inoculation. All studies featured random allocation to treatment groups, placebo-treated control animals and assessment of outcome measures by masked personnel. The product (emodepside+praziquantel topical solution) was 100% effective against mature adults and immature adult T. cati. In addition, it was 96.8% effective against third stage larvae and at least 99.4% effective against fourth stage larvae of T. cati, respectively. Efficacy against mature, immature adult and L4 stages of T. leonina exceeded 93.4%, but regulatory "adequacy of infection" criteria were not met in some studies. No adverse reactions to treatment were noted in cats treated with the emodepside+praziquantel topical solution.

  19. Prospective Analysis of the Safety and Efficacy of Percutaneous Cryoablation for pT1NxMx Biopsy-Proven Renal Cell Carcinoma

    SciTech Connect

    Rodriguez, Ronald; Cizman, Ziga; Hong, Kelvin; Koliatsos, Alexandra; Georgiades, Christos

    2011-06-15

    Purpose: Our objective was to determine the efficacy and safety of image-guided, percutaneous cryoablation for American Joint Committee on Cancer pT1ANxMx and pT1BNxMx biopsy-proven renal cell carcinoma (RCC). Materials and Methods: Computed tomography (CT)-guided, percutaneous cryoablation was used to treat 117 renal lesions in 113 consecutive patients with pT1NxMx RCC. All 117 ablations were included in the safety analysis, and complications were categorized according to Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0). Eighty-one lesions were biopsy-proven RCC and were included in the efficacy analysis. Technical success was defined as the 'ice-ball' covering the entire lesion plus a minimum 5-mm margin. Efficacy was defined as complete lack of enhancement and continuous decrease in size on subsequent follow-up imaging studies. Results: Technical success was 100%, with 15% of ablations requiring air or saline injection to prevent nontarget ablation. We recorded a 7% rate of clinically significant complications (CTCAE category {>=}2) and 0% mortality. Renal function was not adversely affected. Seventy percent of patients were discharged to home on the same day. Efficacy was 98.7% for a median follow-up of 67 weeks (range 7-172). For the subgroup of patients that reached a median follow-up of 2 (n = 59) and 3 years (n = 13), efficacy was 98.3 and 92.3%, respectively. Cancer specific survival was 100%. Conclusions: CT-guided, percutaneous cryoablation has an excellent safety and efficacy profile for stage T1A and T1B RCC; however, longer follow-up is needed to compare it with other nephron-sparing surgical treatments. It is a great option for nonsurgical patients, those in whom renal function cannot be further sacrificed, and those at risk for metachronous lesions.

  20. Evaluation Models for Continuing Education Program Efficacy: How Does Athletic Training Continuing Education Measure up?

    ERIC Educational Resources Information Center

    Doherty-Restrepo, Jennifer L.; Hughes, Brian J.; Del Rossi, Gianluca; Pitney, William A.

    2009-01-01

    Objective: Although continuing education is required for athletic trainers (AT) to maintain their Board of Certification credential, little is known regarding its efficacy for advancing knowledge and improving patient care. Continuing professional education (CPE) is designed to provide professionals with important practical learning opportunities.…

  1. Safety and efficacy evaluation of gelatin-based nanoparticles associated with UV filters.

    PubMed

    de Oliveira, Camila Areias; Dario, Michelli Ferrera; Sarruf, Fernanda Daud; Mariz, Inês Fátima Afonso; Velasco, Maria Valéria Robles; Rosado, Catarina; Baby, André Rolim

    2016-04-01

    The safety and efficacy assessment of nanomaterials is a major concern of industry and academia. These materials, due to their nanoscale size, can have chemical, physical, and biological properties that differ from those of their larger counterparts. The encapsulation of natural ingredients can provide marked improvements in sun protection efficacy. This strategy promotes solubility enhancement of flavonoids and yields an improved active ingredient with innovative physical, physicochemical and functional characteristics. Rutin, a flavonoid, has chemical and functional stability in topical vehicles exerting a synergistic effect in association with ultraviolet (UV) filters. However, the solubility of rutin is a limiting factor. Additionally, this bioactive compound does not have tendency to permeate across the stratum corneum. As an alternative to common synthetic based sunscreens, rutin-entrapped gelatin nanoparticles were designed. The present study investigated the pre-clinical safety of gelatin nanoparticles (GNPs) using an in vitro method and also assessed the clinical safety and efficacy of the association of GNPs with three commonly used chemical UV filters (ethylhexyl dimethyl PABA, ethylhexyl methoxycinnamate and methoxydibenzoylmethane). The non-irritant and adequate safety profile under sun-exposed skin conditions of the nanomaterials and the emulsions qualified the products for clinical efficacy assays. The in vivo results indicated that the GNPs increased the antioxidant protection of the emulsions developed. However, the presence of rutin in the nanosized material did not enhance performance on the SPF test. In conclusion, these findings characterized the nanomaterials as an innovative platform for multifunctional bioactive sunscreens.

  2. Approaches for improving present laboratory and field methodology for evaluation efficacy of transgenic technologies

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Assessing the efficacy of transgenic plants under new environmental and management regimes is of prime importance to the companies which produce new or improved existing transgenic products, breeders which create different varieties stacked with Bt endotoxins, and growers who use them for production...

  3. Development of an improved vaccine evaluation protocol to compare the efficacy of Newcastle disease vaccines

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The failure to control and to eradicate Newcastle Disease (ND) with vaccination alone in countries where the etiological agent of the disease, virulent Newcastle Disease Virus (vNDV) is endemic underscores the need to improve the efficacy of currently available NDV vaccines and vaccination approache...

  4. Development and Psychometric Evaluation of the High School Chemistry Self-Efficacy Scale

    ERIC Educational Resources Information Center

    Aydin, Yesim Capa; Uzuntiryaki, Esen

    2009-01-01

    The aim of this study was to develop a scale assessing high school students' self-efficacy beliefs in chemistry-related tasks and to assess psychometric properties of scores on this scale. A pilot study with a sample of 150 high school students provided initial evidence for two-factor structure of 16-item scale, named High School Chemistry…

  5. Hemostatic efficacy evaluation of radiation crosslinked carboxymethyl kappa-carrageenan and chitosan with varying degrees of substitution

    NASA Astrophysics Data System (ADS)

    Tranquilan-Aranilla, Charito; Barba, Bin Jeremiah D.; Vista, Jeanina Richelle M.; Abad, Lucille V.

    2016-07-01

    Carboxymethyl derivatives of kappa-carrageenan and chitosan, with varying degrees of substitution, were synthesized by multi-step reaction technique and evaluated for hemostatic efficacy through in vitro assays. FTIR analysis confirmed the presence of carboxymethyl group while 1H NMR spectroscopy indicated degrees of substitution ranging from 1.15-1.58 and 0.45-0.51 for carboxymethyl-κ-carrageenan and carboxymethylchitosan, respectively. Derivatives formed into paste consistency (30% w/v) were successfully crosslinked by gamma irradiation at 30 kGy. The data obtained from whole blood clotting and platelet adhesion assays showed a significant increase in hemostatic capability of κ-carrageenan and chitosan as a consequence of carboxymethylation and crosslinking modifications. In addition, the level of efficacy was comparable to that of a chitosan-based commercial product. These results suggest the potential of κ-carrageenan and chitosan derivatives for development into hemostatic agents.

  6. A Drug-Target Network-Based Approach to Evaluate the Efficacy of Medicinal Plants for Type II Diabetes Mellitus

    PubMed Central

    Gu, Jiangyong; Chen, Lirong; Yuan, Gu; Xu, Xiaojie

    2013-01-01

    The use of plants as natural medicines in the treatment of type II diabetes mellitus (T2DM) has long been of special interest. In this work, we developed a docking score-weighted prediction model based on drug-target network to evaluate the efficacy of medicinal plants for T2DM. High throughput virtual screening from chemical library of natural products was adopted to calculate the binding affinity between natural products contained in medicinal plants and 33 T2DM-related proteins. The drug-target network was constructed according to the strength of the binding affinity if the molecular docking score satisfied the threshold. By linking the medicinal plant with T2DM through drug-target network, the model can predict the efficacy of natural products and medicinal plant for T2DM. Eighteen thousand nine hundred ninety-nine natural products and 1669 medicinal plants were predicted to be potentially bioactive. PMID:24223610

  7. Prospective evaluation of clinical scoring systems in infants with bronchiolitis admitted to the intensive care unit.

    PubMed

    Rödl, S; Resch, B; Hofer, N; Marschitz, I; Madler, G; Eber, E; Zobel, G

    2012-10-01

    The objective of this investigation was to compare different scoring systems to assess the severity of illness in infants with bronchiolitis admitted to a tertiary paediatric intensive care unit (PICU). Over an 18-year period (1990-2007), infants with bronchiolitis aged up to 12 months and admitted to the PICU were prospectively scored using the Pediatric Risk of Mortality III (PRISM III) score, the Organ System Failure (OSF) score and the Acute Physiologic Score for Children (APSC) within 24 h. Infants were compared as to whether or not bronchiolitis was associated with respiratory syncytial virus (RSV). There was no difference between 113 RSV-positive and 80 RSV-negative infants regarding gestational age, birth weight, rate of premature delivery or bronchopulmonary dysplasia (BPD). The PRISM III score differed significantly between RSV-positive and RSV-negative cases (3.27 ± 0.39 vs. 1.96 ± 0.44, p = 0.006), as did the OSF score (0.56 ± 0.05 vs. 0.35 ± 0.06, p = 0.049) and the APSC (5.16 ± 0.46 vs. 4.1 ± 0.53, p = 0.048). All scores were significantly higher in the subgroup with mechanical ventilation (p < 0.0001). The mean time of ventilation was significantly higher in the RSV-positive group compared to the RSV-negative group (6.39 ± 1.74 days vs. 2.4 ± 0.47 days, p < 0.001). Infants suffering from RSV-positive bronchiolitis had higher clinical scores corresponding with the severity of bronchiolitis.

  8. Use of the SONET score to evaluate Urgent Care Center overcrowding: a prospective pilot study

    PubMed Central

    Wang, Hao; Robinson, Richard D; Cowden, Chad D; Gorman, Violet A; Cook, Christopher D; Gicheru, Eugene K; Schrader, Chet D; Jayswal, Rani D; Zenarosa, Nestor R

    2015-01-01

    Objectives To derive a tool to determine Urgent Care Center (UCC) crowding and investigate the association between different levels of UCC overcrowding and negative patient care outcomes. Design Prospective pilot study. Setting Single centre study in the USA. Participants 3565 patients who registered at UCC during the 21-day study period were included. Patients who had no overcrowding statuses estimated due to incomplete collection of operational variables at the time of registration were excluded in this study. 3139 patients were enrolled in the final data analysis. Primary and secondary outcome measures A crowding estimation tool (SONET: Severely overcrowded, Overcrowded and Not overcrowded Estimation Tool) was derived using the linear regression analysis. The average length of stay (LOS) in UCC patients and the number of left without being seen (LWBS) patients were calculated and compared under the three different levels of UCC crowding. Results Four independent operational variables could affect the UCC overcrowding score including the total number of patients, the number of results pending for patients, the number of patients in the waiting room and the longest time a patient was stationed in the waiting room. In addition, UCC overcrowding was associated with longer average LOS (not overcrowded: 133±76 min, overcrowded: 169±79 min, and severely overcrowded: 196±87 min, p<0.001) and an increased number of LWBS patients (not overcrowded: 0.28±0.69 patients, overcrowded: 0.64±0.98, and severely overcrowded: 1.00±0.97). Conclusions The overcrowding estimation tool (SONET) derived in this study might be used to determine different levels of crowding in a high volume UCC setting. It also showed that UCC overcrowding might be associated with negative patient care outcomes. PMID:25872940

  9. Prospective, multicenter evaluation of balloon sinus dilation for treatment of pediatric chronic rhinosinusitis

    PubMed Central

    Rosenbloom, Jeffrey S.; Skarada, Douglas; Gutman, Michael; Hoy, Mark J.; Nguyen, Shaun A.

    2016-01-01

    Background Although balloon sinus dilation is a treatment option for adults with chronic rhinosinusitis (CRS), there have been few studies performed in pediatric patients. Methods This study was designed as a prospective, multicenter, single‐arm investigation. Children (2 to 21 years old) with CRS who had failed medical management were treated with balloon sinus dilation and followed to 6 months postprocedure. Results Fifty children were treated at 4 centers; 33 participants were 2 to 12 years old (mean ± standard deviation age: 6.6 ± 2.2 years) and 17 participants were >12 to 21 years (mean age: 15.7 ± 2.5 years). A total of 157 sinus dilations were attempted (98 maxillary, 30 frontal, and 29 sphenoid sinuses) and all were successful with no complications. Significant improvement in the Sinus and Nasal Quality of Life Survey (SN‐5) was seen for all children between baseline and 6 months (4.6 ± 1.2 vs 1.7 ± 0.8; p < 0.0001) and 92% improved by a minimal clinically important difference (MCID) of 1.0 or more. Those children aged 2 to 12 years with standalone balloon dilation also showed significant SN‐5 improvements between baseline and follow‐up (4.5 ± 1.0 vs 1.9 ± 0.8; p < 0.0001). Multivariate regression analysis showed no differences or associations of SN‐5 improvement at 6 months with the presence of allergy, asthma, or concomitant procedures. For adolescents, overall 22‐item Sino‐Nasal Outcome Test (SNOT‐22) mean scores were also significantly improved at 6 months (42.2 ± 19.2 vs 10.4 ± 9.7; p < 0.0001). Conclusion Balloon sinus dilation is safe and appears effective for children with CRS aged 2 years and older. PMID:27888649

  10. A Prospective Evaluation of Systemic Biomarkers and Cognitive Function Associated with Carotid Revascularization

    PubMed Central

    Zuniga, Mary C.; Tran, Thuy B.; Baughman, Brittanie D.; Raghuraman, Gayatri; Hitchner, Elizabeth; Rosen, Allyson; Zhou, Wei

    2017-01-01

    Objective To determine factors affecting cognition and identify predictors of long-term cognitive impairment following carotid revascularization procedures. Background Cognitive impairment is common in older patients with carotid occlusive diseases. Methods Patients undergoing carotid intervention for severe occlusive diseases were prospectively recruited. Patients received neurocognitive testing before, 1, and 6 months after carotid interventions. Plasma samples were also collected within 24 hours after carotid intervention and inflammatory cytokines were analyzed. Univariate and multivariate logistic regressions were performed to identify risk factors associated with significant cognitive deterioration (>10% decline). Results A total of 98 patients (48% symptomatic) were recruited, including 55 patients receiving carotid stenting and 43 receiving endarterectomy. Mean age was 69 (range 54–91 years). Patients had overall improvement in cognitive measures 1 month after revascularization. When compared with carotid stenting, endarterectomy patients demonstrated postoperative improvement in cognition at 1 and 6 months compared with baseline. Carotid stenting (odds ratio 6.49, P = 0.020) and age greater than 80 years (odds ratio 12.6, P = 0.023) were associated with a significant long-term cognitive impairment. Multiple inflammatory cytokines also showed significant changes after revascularization. On multivariate analysis, after controlling for procedure and age, IL-12p40 (P = 0.041) was associated with a higher risk of significant cognitive impairment at 1 month; SDF1-α (P = 0.004) and tumor necrosis factor alpha (P = 0.006) were independent predictors of cognitive impairment, whereas interleukin-6 (P = 0.019) demonstrated cognitive protective effects at 6 months after revascularization. Conclusions Carotid interventions affect cognitive function. Systemic biomarkers can be used to identify patients at risk of significant cognitive decline postprocedures that

  11. Evaluation of the safety, immunogenicity and efficacy of three capripoxvirus vaccine strains against lumpy skin disease virus.

    PubMed

    Gari, Getachew; Abie, Getnet; Gizaw, Daniel; Wubete, Alehegn; Kidane, Membere; Asgedom, Hagos; Bayissa, Berecha; Ayelet, Gelagay; Oura, Christopher A L; Roger, Francois; Tuppurainen, Eeva S M

    2015-06-22

    The safety, immunogenicity and efficacy of three commercially available vaccines against lumpy skin disease (LSD) in cattle have been evaluated using a combination of vaccine challenge experiments and the monitoring of immune responses in vaccinated animals in the field. The three vaccines evaluated in the study included two locally produced (Ethiopian) vaccines (lumpy skin disease virus (LSDV) Neethling and Kenyan sheep and goat pox (KSGP) O-180 strain vaccines) and a Gorgan goat pox (GTP) vaccine manufactured by Jordan Bio-Industries Centre (JOVAC). The latter vaccine was evaluated for the first time in cattle against LSDV. The Ethiopian Neethling and KSGPO-180 vaccines failed to provide protection in cattle against LSDV, whereas the Gorgan GTP vaccine protected all the vaccinated calves from clinical signs of LSD. There was no significant difference in protective efficacy detected between two dosage levels (P=0.2, P=0.25, and P=0.1 for KSGP, Neethling and Gorgan vaccines, respectively). Additionally, the Gorgan GTP vaccinated cattle showed stronger levels of cellular immune responses measured using Delayed-Type Hypersensitivity (DTH) reactions at the vaccination site indicating higher levels of immunogenicity produced by the GTPV vaccine in cattle, as opposed to the other two vaccines. This study indicated, for the first time, that the Gorgan GTP vaccine can effectively protect cattle against LSDV and that the Neethling and KSGP O-180 vaccine were not protective. The results emphasise the need for molecular characterization of the Neethling and KSGP O-180 vaccine seed viruses used for vaccine production in Ethiopia. In addition, the potency and efficacy testing process of the Ethiopian LSD Neethling and KSGP O-180 vaccines should be re-evaluated.

  12. The Effect of Problem Posing Oriented Analyses-II Course on the Attitudes toward Mathematics and Mathematics Self-Efficacy of Elementary Prospective Mathematics Teachers

    ERIC Educational Resources Information Center

    Akay, Hayri; Boz, Nihat

    2010-01-01

    Research on mathematics teaching and learning has recently focused on affective variables, which were found to play an essential role that influences behaviour and learning. Despite its importance, problem posing has not yet received the attention it warrants from the mathematics education community. Perceived self-efficacy beliefs have been found…

  13. Evaluation of the efficacy and safety of a standardised intracameral combination of mydriatics and anaesthetics for cataract surgery

    PubMed Central

    Labetoulle, Marc; Findl, Oliver; Malecaze, François; Alió, Jorge; Cochener, Béatrice; Lobo, Conceição; Lazreg, Sihem; Hartani, Dahbia; Colin, Joseph; Tassignon, Marie-José; Behndig, Anders

    2016-01-01

    Background/aims To compare the efficacy and safety of intracameral (IC) administration at the beginning of cataract surgery, of Mydrane, a standardised ophthalmic combination of tropicamide 0.02%, phenylephrine 0.31% and lidocaine 1%, to a standard topical regimen. Methods In this international phase III, prospective, randomised study, the selected eye of 555 patients undergoing phacoemulsification with intraocular lens (IOL) implantation received 200 μL of Mydrane (Mydrane group) just after the first incision or a topical regimen of one drop each of tropicamide 0.5% and phenylephrine 10% repeated three times (reference group). The primary efficacy variable was achievement of capsulorhexis without additional mydriatics. The non-inferiority of Mydrane to the topical regimen was tested. The main outcome measures were pupil size, patient perception of ocular discomfort and safety. Results Capsulorhexis without additional mydriatics was performed in 98.9% of patients and 94.7% in the Mydrane and reference groups, respectively. Both groups achieved adequate mydriasis (>7 mm) during capsulorhexis, phacoemulsification and IOL insertion. IOL insertion was classified as ‘routine’ in a statistically greater number of eyes in the Mydrane group compared with the reference group (p=0.047). Patients in the Mydrane group reported statistically greater comfort than the reference group before IOL insertion (p=0.034). Safety data were similar between groups. Conclusions Mydrane is an effective and safe alternative to standard eye drops for initiating and maintaining intraoperative mydriasis and analgesia. Patients who received IC Mydrane were significantly more comfortable before IOL insertion than the reference group. Surgeons found IOL insertion less technically challenging with IC Mydrane. Trial registration number NCT02101359; Results. PMID:26531052

  14. Rationale and design of the Clinical Evaluation of Magnetic Resonance Imaging in Coronary heart disease 2 trial (CE-MARC 2): A prospective, multicenter, randomized trial of diagnostic strategies in suspected coronary heart disease

    PubMed Central

    Ripley, David P.; Brown, Julia M.; Everett, Colin C.; Bijsterveld, Petra; Walker, Simon; Sculpher, Mark; McCann, Gerry P.; Berry, Colin; Plein, Sven; Greenwood, John P.

    2015-01-01

    Background A number of investigative strategies exist for the diagnosis of coronary heart disease (CHD). Despite the widespread availability of noninvasive imaging, invasive angiography is commonly used early in the diagnostic pathway. Consequently, approximately 60% of angiograms reveal no evidence of obstructive coronary disease. Reducing unnecessary angiography has potential financial savings and avoids exposing the patient to unnecessary risk. There are no large-scale comparative effectiveness trials of the different diagnostic strategies recommended in international guidelines and none that have evaluated the safety and efficacy of cardiovascular magnetic resonance. Trial Design CE-MARC 2 is a prospective, multicenter, 3-arm parallel group, randomized controlled trial of patients with suspected CHD (pretest likelihood 10%-90%) requiring further investigation. A total of 1,200 patients will be randomized on a 2:2:1 basis to receive 3.0-T cardiovascular magnetic resonance–guided care, single-photon emission computed tomography–guided care (according to American College of Cardiology/American Heart Association appropriate-use criteria), or National Institute for Health and Care Excellence guidelines–based management. The primary (efficacy) end point is the occurrence of unnecessary angiography as defined by a normal (>0.8) invasive fractional flow reserve. Safety of each strategy will be assessed by 3-year major adverse cardiovascular event rates. Cost-effectiveness and health-related quality-of-life measures will be performed. Conclusions The CE-MARC 2 trial will provide comparative efficacy and safety evidence for 3 different strategies of investigating patients with suspected CHD, with the intension of reducing unnecessary invasive angiography rates. Evaluation of these management strategies has the potential to improve patient care, health-related quality of life, and the cost-effectiveness of CHD investigation. PMID:25497243

  15. The china patient‐centered evaluative assessment of cardiac events (PEACE) prospective study of percutaneous coronary intervention: Study design

    PubMed Central

    Du, Xue; Pi, Yi; Dreyer, Rachel P.; Li, Jing; Li, Xi; Downing, Nicholas S.; Li, Li; Feng, Fang; Zhan, Lijuan; Zhang, Haibo; Guan, Wenchi; Xu, Xiao; Li, Shu‐Xia; Lin, Zhenqiu; Masoudi, Frederick A.; Spertus, John A.; Krumholz, Harlan M.

    2016-01-01

    Background The number of percutaneous coronary interventions (PCI) in China has increased more than 20‐fold over the last decade. Consequently, there is a need for national‐level information to characterize PCI indications and long‐term patient outcomes, including health status, to understand and improve evolving practice patterns. Objectives: This nationwide prospective study of patients receiving PCI is to: (1) measure long‐term clinical outcomes (including death, acute myocardial infarction [AMI], and/or revascularization), patient‐reported outcomes (PROs), cardiovascular risk factor control and adherence to medications for secondary prevention; (2) determine patient‐ and hospital‐level factors associated with care process and outcomes; and (3) assess the appropriateness of PCI procedures. Methods: The China Patient‐centered Evaluative Assessment of Cardiac Events (PEACE) Prospective Study of PCI has enrolled 5,000 consecutive patients during 2012–2014 from 34 diverse hospitals across China undergoing PCI for any indication. We abstracted details of patient's medical history, treatments, and in‐hospital outcomes from medical charts, and conducted baseline, 1‐, 6‐, and 12‐month interviews to characterize patient demographics, risk factors, clinical presentation, healthcare utilization, and health status using validated PRO measures. The primary outcome, a composite measure of death, AMI and/or revascularization, as well as PROs, medication adherence and cardiovascular risk factor control, was assessed throughout the 12‐month follow‐up. Blood and urine samples were collected at baseline and 12 months and stored for future analyses. To validate reports of coronary anatomy, 2,000 angiograms are randomly selected and read by two independent core laboratories. Hospital characteristics regarding their facilities, processes and organizational characteristics are assessed by site surveys. Conclusion: China PEACE Prospective Study of PCI will

  16. Prospective evaluation of indirect costs due to acute rotavirus gastroenteritis in Spain: the ROTACOST study

    PubMed Central

    2011-01-01

    Background The effect of rotavirus in developed countries is mainly economic. This study aimed to assess the indirect costs induced by rotavirus acute gastroenteritis (RVAGE) in Spain. Methods A prospective observational study was conducted from October 2008 to June 2009. It included 682 children up to 5 years of age with acute gastroenteritis (AGE) who attended primary care (n = 18) and emergency room/hospital settings (n = 10), covering the regions of Galicia and Asturias (North-west Spain). All non-medical expenses incurred throughout the episode were recorded in detail using personal interviews and telephone contact. Results Among the 682 enrolled children, 207 (30.4%) were rotavirus positive and 170 (25%) had received at least one dose of rotavirus vaccine. The mean (standard deviation) indirect cost caused by an episode of AGE was estimated at 135.17 (182.70) Euros. Costs were 1.74-fold higher when AGE was caused by rotavirus compared with other etiologies: 192.7 (219.8) Euros vs. 111.6 (163.5) Euros (p < .001). The costs for absenteeism were the most substantial with a mean of 91.41 (134.76) Euros per family, resulting in a loss of 2.45 (3.17) days of work. In RVAGE patients, the absenteeism cost was 120.4 (154) Euros compared with 75.8 (123) for the other etiologies (p = .002), because of loss of 3.5 (3.6) vs 1.9 (2.9) days of work (p < .001). Meals costs were 2-fold-higher (48.5 (55) vs 24.3 (46) Euros, p < .001) and travel costs were 2.6-fold-higher (32 (92) vs 12.5 (21.1) Euros, p = .005) in RVAGE patients compared with those with other etiologies. There were no differences between RVAGE and other etiologies groups regarding costs of hiring of caregivers or purchase of material. Patients with RVAGE were admitted to hospital more frequently than those with other etiologies (47.8% vs 14%, p < .001). Conclusions Rotavirus generates a significant indirect economic burden. Our data should be considered in the decision-making process of the eventual inclusion

  17. An in vitro and in vivo Evaluation of the Efficacy of Recombinant Human Liver Prolidase as a Catalytic Bioscavenger of Chemical Warfare Nerve Agents

    DTIC Science & Technology

    2015-01-01

    3. DATES COVERED (From - To) 4. TITLE AND SUBTITLE An in vitro and in vivo evaluation of the efficacy of recombinant human liver prolidase 5a...butyrylcholinesterase, catalytic bioscavenger, chemical warfare nerve agents, human liver prolidase, in vivo delivery 16. SECURITY CLASSIFICATION OF: 17...Healthcare USA, Inc. DOI: 10.3109/01480545.2014.90