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Sample records for prospective efficacy evaluation

  1. 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.

  2. Safety and efficacy evaluation of Ayurvedic treatment (Arjuna powder and Arogyavardhini Vati) in dyslipidemia patients: A pilot prospective cohort clinical study

    PubMed Central

    Kumar, Gajendra; Srivastava, Amita; Sharma, Surinder Kumar; Gupta, Yogendra Kumar

    2012-01-01

    Cardiovascular disease has multifaceted in which dyslipidemia, inflammation, and immunity play an important role. Arjuna powder and Arogyavardhini Vati used for centuries has potential for combating these factors. Therefore, the objective of this study was to evaluate the safety and efficacy of Ayurvedic treatment (Arjuna powder and Arogyavardhini Vati) for dyslipidemia patients. Total of 108 patients were screened at CGHS Ayurvedic Hospital, New Delhi. Ninety-six patients satisfied inclusion criteria, and signed informed consent and detailed medical history was recorded. Arjuna powder (5 g, BD) for 3 weeks and then Arogyavardhini Vati (500 mg, BD) for 4 weeks were prescribed to the patients. The primary efficacy endpoint was reduction in serum total cholesterol, LDL, triglycerides, and increased HDL levels. Secondary endpoints included reduction in serum C-Reactive Protein (CRP) and blood glucose levels. Safety assessments included hepatic function (aminotransferase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), bilirubin, and β2 microglobulin), renal function (urea and creatinine and NGAL) tests, and urine mercury level. The study was completed by 87 patients. The male and female patients were 65.5% (57/87) and 34.5% (30/87), respectively. There was a significant reduction in total cholesterol, LDL, triglycerides, CRP, and blood glucose. However, raised HDL level was also observed. Safety assessment results showed no significant change in serum ALT, AST, ALP and bilirubin, urea, creatinine β2 microglobulin, and NGAL levels at the end of study as compared to the baseline levels. In conclusion, the results of the present prospective cohort study showed that Ayurvedic treatment (Arjuna powder and Arogyavardhini Vati) is safe and effective for dyslipidemia. PMID:23559790

  3. 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 betweenin vitroADCC 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 FcγRIIaHalleles 131H/Hand 131H/Rhad significantly higher ADCC compared with patients with the 131R/Ralleles (P= 0.013). Patients carrying FcγRIIIa genotypes with theValleles 158V/Vand 158V/Fdisplayed higher ADCC compared with patients carrying the 158F/Fgenotype (P= 0.001). Progression-free survival of patients with an FcγRIIIa 158Vallele 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 vitrocetuximab-mediated ADCC correlated with FcγR polymorphisms and predicted cetuximab responsiveness.Cancer Immunol Res; 4(4); 366-74. ©2016 AACR. PMID:26817995

  4. 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

  5. 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

  6. 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

  7. Differentiated Instruction: Hong Kong Prospective Teachers' Teaching Efficacy and Beliefs

    ERIC Educational Resources Information Center

    Wan, Sally Wai-Yan

    2016-01-01

    Catering for learner diversity is one of the key areas in the recent educational reform in Hong Kong. Pre-service teacher education acts as a fundamental way to equip pre-service teachers ready for accommodating diverse learning needs and to build up pre-service teachers' self-efficacy. The purpose of the study is to examine prospective teachers'…

  8. 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...

  9. 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

  10. A Prospective, Comparative, Evaluator-blind Clinical Study Investigating Efficacy and Safety of Two Injection Techniques with Radiesse® for the Correction of Skin Changes in Aging Hands

    PubMed Central

    Gubanova, Elena I; Starovatova, Polina A

    2015-01-01

    Background: Dermal fillers are used to correct age-related changes in hands. Aims: Assess efficacy and safety of two injection techniques to treat age-related changes in the hands using calcium hydroxylapatite filler, Radiesse®. Settings and Design: This was a prospective, comparative, evaluator-blind, single-center study. Materials and Methods: Radiesse® (0.8 mL/0.2 mL 2% lidocaine) was injected subdermally on Day (D)01, using a needle multipoint technique in one hand (N) and a fan-like cannula technique in the other (C). Assessments were made pre-injection, on D14, Month (M)02, M03 and M05 using the Merz Aesthetics Hand Grading Scale (MAS) and Global Aesthetic Improvement Scale (GAIS). Participants completed questionnaires on satisfaction, pain and adverse events (AEs). Statistical Analysis Used: Data distribution was tested with the Shapiro-Wilk and Levene's tests. The Wilcoxon signed-rank and Chi-square tests were employed to evaluate quantitative and qualitative data, respectively. Results: All 10 participants completed the study, four opted for a M03 touch-up (0.8 mL Radiesse®). Evaluator-assessed mean GAIS scores were between 2 (significant improvement but not complete correction) and 3 (optimal cosmetic result) at each time point. The MAS score improved from D01 to M05 (N: 2.60 to 1.40; C: 2.20 to 1.30). Following treatment, participants reported skin was softer, more elastic, more youthful and less wrinkled. Other than less noticeable veins and tendons on the C hand, no differences in participant satisfaction were noted. All AEs were mild, with no serious AEs reported. Conclusions: Both injection techniques (needle and cannula) demonstrated equivalent clinical efficacy with a comparable safety profile for the correction of age-related changes in hands with Radiesse®. PMID:26644738

  11. 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

  12. [Prospective evaluation of antidepressant discontinuation].

    PubMed

    Mourad, I; Lejoyeux, M; Adès, J

    1998-01-01

    The authors prospectively assessed symptoms induced by the interruption of antidepressants in 16 patients (11 women and 5 men), aged from 33 to 85 years (mean = 52.4 +/- 16.4), treated with antidepressants since at least two weeks. All patients were free of alcohol abuse or dependence disorder and of other dependence to psychoactive substances. None of them presented medical illness. Diagnosis were made by separate evaluations by two authors and confirmed with a semistructered assessment instrument: the Schedule for Affective Disorders and Schizophrenia (Lifetime Version). All patients were submitted to a brutal discontinuation of their antidepressant agent. Patients were assessed twice, before the interruption of the antidepressant, and 72 hours later. Effects of antidepressant interruption were assessed by several means. Modification of anxiety and depression were evaluated using the Montgomery Asberg Depression Rating Scale (MADRS) and the Hamilton Anxiety Scale. Symptoms of withdrawal were assessed with Cassano and al.'s scale SESSH including an evaluation of anxiety, agitation, irritability, anergy, difficulty on concentrating, depersonalization, sleep and appetite disorders, muscle pains, nausea, tremor, sweating, altered taste, hyperosmia, paresthesias, photophobia, motor incoordination, dizziness, hyperacousia pain, delirium. Fourteen of the 16 patients (87.5%) presented modifications of their somatic or psychic state 3 days after the interruption of the antidepressant treatment. Most frequent symptoms were: increase in anxiety (31%), increase in irritability (25%), sleep disorders (19%), decrease of anergia and fatigue (19%). Mean scores of anxiety and depression were not significantly modified by the withdrawal. Following TCAs interruption (7 patients) most frequent symptoms were sleep disorders; increase in anxiety, nausea. Among patients withdrawn from SSRIs (6 patients), most frequent symptoms were increase in anxiety, increase in irritability

  13. 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

  14. Prospects for Public Library Evaluation.

    ERIC Educational Resources Information Center

    Van House, Nancy A.; Childers, Thomas

    1991-01-01

    Discusses methods of evaluation that can be used to measure public library effectiveness, based on a conference sponsored by the Council on Library Resources. Topics discussed include the Public Library Effectiveness Study (PLES), quantitative and qualitative evaluation, using evaluative information for resource acquisition and resource…

  15. An Investigation of Music Teaching Self-Efficacy Levels of Prospective Preschool Teachers

    ERIC Educational Resources Information Center

    Koca, Sehriban

    2013-01-01

    The aim of the study is to investigate music teaching self-efficacy levels of prospective preschool teachers. The study used survey model. Participants of the study consisted of a total of 120 prospective teachers studying at Mersin University, Faculty of Education, Department of Primary Education Preschool Teaching Program in Mersin, a City in…

  16. 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…

  17. 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…

  18. 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…

  19. Perceived Efficacy Beliefs of Prospective Nigerian Science Teachers

    ERIC Educational Resources Information Center

    Arigbabu, Abayomi A.; Oludipe, Daniel I.

    2010-01-01

    The purpose of this study was to assess differences between Nigerian junior and senior preservice teachers' science teaching efficacy beliefs. Data in this study were collected from a total number of 221 preservice teachers enrolled in junior and senior secondary science teacher education programs in Nigeria using Science Teaching Efficacy Belief…

  20. Retrospect and Prospect of Studies of Teacher Efficacy in China

    ERIC Educational Resources Information Center

    He, Ning; Miao, Danmin

    2006-01-01

    Teacher efficacy is a powerful variable in educational and psychological studies. And it aroused much attention and interest from Chinese scholars in the past decade, which led to an accumulation of documents in this field. Following an introduction of efficacy studies in the west, the article reviews the brief history of those in China,…

  1. A randomised, multi-centre, prospective, double blind pilot-study to evaluate safety and efficacy of the non-absorbable Optilene® Mesh Elastic versus the partly absorbable Ultrapro® Mesh for incisional hernia repair

    PubMed Central

    2010-01-01

    Background Randomised controlled trials with a long term follow-up (3 to 10 years) have demonstrated that mesh repair is superior to suture closure of incisional hernia with lower recurrence rates (5 to 20% versus 20 to 63%). Yet, the ideal size and material of the mesh are not defined. So far, there are few prospective studies that evaluate the influence of the mesh texture on patient's satisfaction, recurrence and complication rate. The aim of this study is to evaluate, if a non-absorbable mesh (Optilene® Mesh Elastic) will result in better health outcomes compared to a partly absorbable mesh (Ultrapro® Mesh). Methods/Design In this prospective, randomised, double blind study, eighty patients with incisional hernia after a midline laparotomy will be included. Primary objective of this study is to investigate differences in the physical functioning score from the SF-36 questionnaire 21 days after mesh insertion. Secondary objectives include the evaluation of the patients' daily activity, pain, wound complication and other surgical complications (hematomas, seromas), and safety within six months after intervention. Discussion This study investigates mainly from the patient perspective differences between meshes for treatment of incisional hernias. Whether partly absorbable meshes improve quality of life better than non-absorbable meshes is unclear and therefore, this trial will generate further evidence for a better treatment of patients. Trial registration NCT00646334 PMID:20624273

  2. 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…

  3. A historically controlled, single-arm, multi-centre, prospective trial to evaluate the safety and efficacy of MonoMax® suture material for abdominal wall closure after primary midline laparotomy. ISSAAC-Trial [NCT005725079

    PubMed Central

    Fischer, Lars; Baumann, Petra; Hüsing, Johannes; Seidlmayer, Christoph; Albertsmeier, Markus; Franck, Annette; Luntz, Steffen; Seiler, Christoph M; Knaebel, Hanns-Peter

    2008-01-01

    Background Several randomized controlled trials have compared different suture materials and techniques for abdominal wall closure with respect to the incidence of incisional hernias after midline laparotomy and shown that it remains, irrespective of the methods used, considerably high, ranging from 9% to 20%. The development of improved suture materials which would reduce postoperative complications may help to lower its frequency. Design This is a historically controlled, single-arm, multi-centre, prospective trial to evaluate the safety of MonoMax® suture material for abdominal wall closure in 150 patients with primary elective midline incisions. INSECT patients who underwent abdominal closure using Monoplus® and PDS® will serve as historical control group. The incidences of wound infections and of burst abdomen are defined as composite primary endpoints. Secondary endpoints are the frequency of incisional hernias within one year after operation and safety. To ensure adequate comparability in surgical performance and recruitment, the 4 largest centres of the INSECT-Trial will participate. After hospital discharge, the investigators will examine the enrolled patients again at 30 days and at 12 ± 1 months after surgery. Conclusion This historically controlled, single-arm, multi-centre, prospective ISSAAC trial aims to assess whether the use of an ultra-long-lasting absorbable monofilament suture material is safe and efficient. Trial registration NCT005725079 PMID:18644124

  4. 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. PMID:14579160

  5. [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. PMID:26887309

  6. 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…

  7. 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 sciences" (physics…

  8. Effects of perceived efficacy and prospect of success on detection in the Guilty Actions Test.

    PubMed

    Zvi, Lisa; Nachson, Israel; Elaad, Eitan

    2015-01-01

    Two experiments were conducted in order to examine factors that might influence the motivation of guilty and informed innocent examinees to either cope or cooperate with the Guilty Actions Test. Guilty participants committed a mock-crime and informed innocent participants handled the critical items of the crime in an innocent context. In Experiment 1 the participants were led to believe that the prospects of being found innocent on the test were either high or low. In Experiment 2 the participants were led to believe that the test was either highly accurate or of questionable validity. Results indicated that for both guilty and informed innocent participants low prospects of success and low detection efficacy of the test were associated with enhanced physiological responses to the critical information, whereas high prospects of success and high detection efficacy were associated with attenuated physiological responses. Theoretical and practical implications of the results are discussed. PMID:25543067

  9. A prospective study comparing the efficacy and safety of two sublingual birch allergen preparations

    PubMed Central

    2014-01-01

    Background SUBLIVAC FIX Birch (SUB-B) is a liquid oral preparation of Betula verrucosa pollen extract for the treatment of allergic rhinitis/rhinoconjuctivitis induced by birch pollen. The major allergen content of SUB-B and Staloral Birch (Stal-B) have been shown to be comparable. In order to compare the clinical efficacy and safety of both products, the present study was designed to investigate efficacy of treatment with SUB-B compared to Stal-B by means of reduction in allergy symptoms assessed by a titrated nasal provocation test (TNPT) in subjects suffering from IgE mediated allergy complaints triggered by birch pollen. Methods A prospective, randomized, open, blinded endpoint (PROBE), controlled, single-centre study in 74 birch allergic adults was performed. Treatment consisted of either SUB-B (10,000 AUN/ml) or Stal-B (initial phase 10 I.R./ml and maintenance phase 300 I.R./ml) for 16–20 weeks at maintenance dose. The primary efficacy outcome was defined by the difference in change of the TNPT-threshold dose between the two treatment groups at baseline and after completion of treatment. Secondary outcomes included determination of birch pollen specific IgE and IgG levels, safety lab and ECG. During the first 30 days of treatment, subjects were requested to fill out a diary concerning compliance with study medication, occurrence of AEs and the use of concomitant medication. Results Analysis of the primary efficacy parameter showed that the percentage of subjects showing a beneficial treatment effect was similar in both treatment groups, 33.3% for SUB-B vs. 31.4% for Stal-B in the intention to treat population. Evaluation of the immunologic response, showed that treatment with SUB-B and Stal-B induced similar increases (approximately 2 times) in IgE, IgG and IgG4 specific for Bet v 1. In total, 143 related adverse events (AEs) were reported. The majority of the AEs was of mild intensity. The same pattern of AEs was observed for both products. No clinically

  10. Comparison of the efficacy and safety of rosuvastatin 10 mg and atorvastatin 20 mg in high-risk patients with hypercholesterolemia – Prospective study to evaluate the Use of Low doses of the Statins Atorvastatin and Rosuvastatin (PULSAR)

    PubMed Central

    Clearfield, Michael B; Amerena, John; Bassand, Jean-Pierre; García, Hugo R Hernández; Miller, Sam S; Sosef, Froukje FM; Palmer, Michael K; Bryzinski, Brian S

    2006-01-01

    Background Many patients at high risk of cardiovascular disease do not achieve recommended low-density lipoprotein cholesterol (LDL-C) goals. This study compared the efficacy and safety of low doses of rosuvastatin (10 mg) and atorvastatin (20 mg) in high-risk patients with hypercholesterolemia. Methods A total of 996 patients with hypercholesterolemia (LDL-C ≥ 3.4 and < 5.7 mmol/L [130 and 220 mg/dL]) and coronary heart disease (CHD), atherosclerosis, or a CHD-risk equivalent were randomized to once-daily rosuvastatin 10 mg or atorvastatin 20 mg. The primary endpoint was the percentage change from baseline in LDL-C levels at 6 weeks. Secondary endpoints included LDL-C goal achievement (National Cholesterol Education Program Adult Treatment Panel III [NCEP ATP III] goal < 100 mg/dL; 2003 European goal < 2.5 mmol/L for patients with atherosclerotic disease, type 2 diabetes, or at high risk of cardiovascular events, as assessed by a Systematic COronary Risk Evaluation (SCORE) risk ≥ 5% or 3.0 mmol/L for all other patients), changes in other lipids and lipoproteins, cost-effectiveness, and safety. Results Rosuvastatin 10 mg reduced LDL-C levels significantly more than atorvastatin 20 mg at week 6 (44.6% vs. 42.7%, p < 0.05). Significantly more patients achieved NCEP ATP III and 2003 European LDL-C goals with rosuvastatin 10 mg compared with atorvastatin 20 mg (68.8% vs. 62.5%, p < 0.05; 68.0% vs. 63.3%, p < 0.05, respectively). High-density lipoprotein cholesterol was increased significantly with rosuvastatin 10 mg versus atorvastatin 20 mg (6.4% vs. 3.1%, p < 0.001). Lipid ratios and levels of apolipoprotein A-I also improved more with rosuvastatin 10 mg than with atorvastatin 20 mg. The use of rosuvastatin 10 mg was also cost-effective compared with atorvastatin 20 mg in both a US and a UK setting. Both treatments were well tolerated, with a similar incidence of adverse events (rosuvastatin 10 mg, 27.5%; atorvastatin 20 mg, 26.1%). No cases of rhabdomyolysis

  11. Evaluation of the Efficacy of Methylprednisolone, Etoricoxib and a Combination of the Two Substances to Attenuate Postoperative Pain and PONV in Patients Undergoing Laparoscopic Cholecystectomy: A Prospective, Randomized, Placebo-controlled Trial

    PubMed Central

    Agarwal, Amita; Das, Pravin Kumar; Agarwal, Anil; Kumar, Sanjay; Khuba, Sandeep

    2014-01-01

    Background Establishment of laparoscopic cholecystectomy as an outpatient procedure has accentuated the clinical importance of reducing early postoperative pain, as well as postoperative nausea and vomiting (PONV). We therefore planned to evaluate the role of a multimodal approach in attenuating these problems. Methods One hundred and twenty adult patients of ASA physical status I and II and undergoing elective laparoscopic cholecystectomy were included in this prospective, randomized, placebo-controlled study. Patients were divided into four groups of 30 each to receive methylprednisolone 125 mg intravenously or etoricoxib 120 mg orally or a combination of methylprednisolone 125 mg intravenously and etoricoxib 120 mg orally or a placebo 1 hr prior to surgery. Patients were observed for postoperative pain, fentanyl consumption, PONV, fatigue and sedation, and respiratory depression. Results were analyzed by the ANOVA, a Chi square test, the Mann Whitney U test and by Fisher's exact test. P values of less than 0.05 were considered to be significant. Results Postoperative pain and fentanyl consumption were significantly reduced by methylprednisolone, etoricoxib and their combination when compared with placebo (P<0.05). The methylprednisolone + etoricoxib combination caused a significant reduction in postoperative pain and fentanyl consumption as compared to methylprednisolone or etoricoxib alone (P<0.05); however, there was no significant difference between the methylprednisolone and etoricoxib groups (P>0.05). The methylprednisolone and methylprednisolone + etoricoxib combination significantly reduced the incidence and severity of PONV and fatigue as well as the total number of patients requiring an antiemetic treatment compared to the placebo and etoricoxib (P<0.05). Conclusions A preoperative single-dose administration of a combination of methylprednisolone and etoricoxib reduces postoperative pain along with fentanyl consumption, PONV, antiemetic requirements and

  12. 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. PMID:25746166

  13. 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. PMID:26392114

  14. Efficacy of electroconvulsive therapy in treatment-resistant schizophrenia: a prospective open trial.

    PubMed

    Tang, Wai-Kwong; Ungvari, Gabor S

    2003-05-01

    There is a lack of controlled trials examining the effectiveness of electroconvulsive therapy (ECT) combined with olanzapine or risperidone in treatment-resistant schizophrenia (TRS). The authors conducted a prospective, open, controlled trial of ECT in TRS in a long-term psychiatric rehabilitation unit in Hong Kong. Thirty patients with TRS from an inpatient psychiatric rehabilitation unit participated in this study. All subjects were resistant to a host of antipsychotic medications given singly or in different combinations. In addition, they were also resistant to or they refused clozapine treatment. Fifteen patients completed a course of ECT consisting of 8-20 sessions. Fifteen patients who refused ECT formed the control Subjects were assessed at baseline, 1 week, 1 month, and 2 months after their last ECT. Assessment instruments included the Brief Psychiatric Rating Scale (BPRS), Hamilton Depression Rating Scale (HDRS), Scale for the Assessment of Negative Symptoms (SANS), Global Assessment Scale (GAS), Clinical Global Impression (CGI), CGI Severity of Illness [CGI(SOI)], CGI Global Improvement [CGI(GI)], Nurses' Observation Scale for Inpatient Evaluation (NOSIE-30), and occupational therapists' rating of the subjects' functioning with respect to work (OT-W), social (OT-S), and leisure (OT-L) activities. In comparison with the control group, the ECT group showed statistically significant improvement only in the GAS and CGI at each posttreatment evaluation. There was a trend for ECT to reduce positive and negative symptoms, although the rate of improvement did not reach statistically significant levels. ECT augmentation of risperidone and olanzapine is of marginal efficacy compared to reports of the greater augmentation of these antipsychotics with other agents. PMID:12691772

  15. 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…

  16. A prospective, randomized, controlled, clinical study to evaluate the efficacy of high-frequency ultrasound in the treatment of Stage II and Stage III pressure ulcers in geriatric patients.

    PubMed

    Polak, Anna; Franek, Andrzej; Blaszczak, Edward; Nawrat-Szoltysik, Agnieszka; Taradaj, Jakub; Wiercigroch, Lidia; Dolibog, Pawel; Stania, Magdalena; Juras, Grzegorz

    2014-08-01

    International guidelines recommend high-frequency ultrasound (HFUS; MHz) for treating infected pressure ulcers (PUs). A 2-year, prospective, randomized, controlled study was conducted to evaluate how HFUS affects PU healing among 42 geriatric patients treated in four nursing and care centers in Silesia, Poland. Participants (age range 71-95 years,) all with wounds that did not respond to previous treatment for at least 4 weeks, were randomly assigned to the treatment group (TG) (20 with 21 PUs, mean age 83.60 ± 5.04 years) or control group (CG) (22 with 23 PUs, mean age 82.59 ± 6.65 years). All patients received standard wound care (SWC); the TG additionally was provided HFUS (1 MHz, 0.5 W/ cm2, duty cycle of 20%, 1-3 minutes/cm2; one session per day, 5 days a week). Patients were monitored for 6 weeks or until wounds closed. Percent change in wound surface area (WSA), the Gilman's parameter, the weekly rate of change in WSA, and the percentage of PUs that improved (ie, decreased in size by at least 50% or closed) were used to compare differences. Data were analyzed using Fisher's exact test, the Wilcoxon matched pairs test, and the Mann-Whitney U test (P <0.05). Mean baseline WSA and the pretreatment duration of PUs were 15.38 ± 12.92 cm2 and 1.64 ± 0.73 months and 11.08 ± 7.52 cm2 and 2.26 ± 1.42 months in the TG and CG groups, respectively. After 6 weeks of treatment, the WSA of PUs decreased significantly in both groups (P = 0.000069 in the TG and P = 0.0062 in the CG) with significantly greater improvement in the TG (an average of 68.80% ± 37.23% compared with 37.24% ± 57.84%; P = 0.047). The value of the Gilman's parameter was greater in the TG than in the CG (0.88 ± 0.62 and 0.43 ± 0.50, respectively; P = 0.018). The mean weekly change of WSA was greater in the TG than in the CG but only for Stage II PUs (3.09 ± 2.93 cm2/week and 1.08 ± 1.43 cm2/week; P = 0.045). More Stage II PUs in the TG decreased by at least 50% (11 of 14 = 78.57%) than in

  17. An Extension Analysis on the Self-Efficacy Beliefs about Equitable Science Teaching and Learning Instrument for Prospective Elementary Teachers.

    ERIC Educational Resources Information Center

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

    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 regard to science teaching and learning for diverse learners. The study builds upon the work of Ashton, Webb, and Bandura. The Self-Efficacy Beliefs about Equitable Science…

  18. 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…

  19. Efficacy of first-line tocilizumab therapy in early polymyalgia rheumatica: a prospective longitudinal study

    PubMed Central

    Devauchelle-Pensec, Valérie; Berthelot, Jean Marie; Cornec, Divi; Marhadour, Thierry; Jousse-Joulin, Sandrine; Querellou, Solène; Garrigues, Florent; De Bandt, Michel; Gouillou, Maelenn; Saraux, Alain

    2016-01-01

    Background Glucocorticoids are the cornerstone treatment of polymyalgia rheumatica (PMR) but induce adverse events. Objectives To evaluate the efficacy and safety of first-line tocilizumab in PMR. Methods In a prospective open-label study (ClinicalTrials.gov: NCT01713842), 20 glucocorticoid-free patients fulfilling Chuang's PMR criteria, with symptom onset within the last 12 months and a PMR activity score (PMR-AS) >10, each received three tocilizumab infusions at 4-week intervals, without glucocorticoids, followed by oral prednisone from weeks 12 to 24 (0.15 mg/kg if PMR-AS ≤10 and 0.30 mg/kg otherwise). The primary end point was the proportion of patients with PMR-AS≤10 at week 12. Results Baseline median PMR-AS was 36.6 (IQR 30.4–43.8). At week 12, all patients had PMR-AS≤10 and received the low prednisone dosage. Median PMR-AS at weeks 12 and 24 was 4.5 (3.2–6.8) and 0.95 (IQR 0.4–2), respectively (p<0.001 vs baseline for both time points). No patient required rescue treatment. Positron emission tomography-CT showed significant improvements. The most common adverse events were transient neutropenia (n=3) and leucopenia (n=5); in one patient, the second tocilizumab infusion was omitted due to leucopenia. Conclusions Tocilizumab monotherapy is effective in recent-onset PMR. Randomised controlled trials are warranted. Trial registration number NCT01713842. PMID:26929219

  20. Contribution of Geophysical Prospecting to Geohazard Evaluation

    NASA Astrophysics Data System (ADS)

    Nicolich, Rinaldo

    2006-03-01

    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

  1. 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

  2. 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

  3. Effect of Pitavastatin Treatment on ApoB-48 and Lp-PLA2 in Patients with Metabolic Syndrome: Substudy of PROspective Comparative Clinical Study Evaluating the Efficacy and Safety of PITavastatin in Patients with Metabolic Syndrome

    PubMed Central

    Lee, Hyo-Sun; Jung, Chang Hee; Kim, Sung Rae; Jang, Hak Chul

    2016-01-01

    Background Apolipoprotein (Apo) B-48 is an intestinally derived lipoprotein that is expected to be a marker for cardiovascular disease (CVD). Lipoprotein-associated phospholipase A2 (Lp-PLA2) is a vascular-specific inflammatory marker and important risk predictor of CVD. The aim of this study was to explore the effect of pitavastatin treatment and life style modification (LSM) on ApoB-48 and Lp-PLA2 levels in metabolic syndrome (MS) patients at relatively low risk for CVD, as a sub-analysis of a previous multi-center prospective study. Methods We enrolled 75 patients with MS from the PROPIT study and randomized them into two treatment groups: 2 mg pitavastatin daily+intensive LSM or intensive LSM only. We measured the change of lipid profiles, ApoB-48 and Lp-PLA2 for 48 weeks. Results Total cholesterol, low density lipoprotein cholesterol, non-high density lipoprotein cholesterol, and ApoB-100/A1 ratio were significantly improved in the pitavastatin+LSM group compared to the LSM only group (P≤0.001). Pitavastatin+LSM did not change the level of ApoB-48 in subjects overall, but the level of ApoB-48 was significantly lower in the higher mean baseline value group of ApoB-48. The change in Lp-PLA2 was not significant after intervention in either group after treatment with pitavastatin for 1 year. Conclusion Pitavastatin treatment and LSM significantly improved lipid profiles, ApoB-100/A1 ratio, and reduced ApoB-48 levels in the higher mean baseline value group of ApoB-48, but did not significantly alter the Lp-PLA2 levels. PMID:26754586

  4. Self-Efficacy, Self-Evaluation, and Social Loafing.

    ERIC Educational Resources Information Center

    Susman, Ellen B.; Sanna, Lawrence J.

    This study examined the effect of efficacy expectancy and valence of expected evaluation on social loafing (the tendency to put forth less effort when working collectively than when working individually) among 120 undergraduate students. Participants completed the Remote Associates Test. Efficacy expectancies were manipulated by varying…

  5. 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

  6. 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)…

  7. 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. PMID:24082784

  8. 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

  9. 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…

  10. 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.

  11. 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. PMID:19466645

  12. 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…

  13. 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…

  14. 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…

  15. 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.

  16. 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

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

    PubMed

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

    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

  18. Testing the prospective evaluation of a new healthcare system.

    PubMed

    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

  19. Excellent uricosuric efficacy of benzbromarone in cyclosporin-A-treated renal transplant patients: a prospective study.

    PubMed

    Zürcher, R M; Bock, H A; Thiel, G

    1994-01-01

    Patients on cyclosporin A (CsA) often develop hyperuricaemia and gout. In transplant patients the use of uricosuric drugs for treating hyperuricaemia may be preferable to allopurinol because of the known interaction of the latter with azathioprine. We therefore prospectively studied the uricosuric efficacy of 100 mg benzbromarone (Bbr;Desuric) daily in 25 CsA-treated renal transplant patients with stable graft function and hyperuricaemia (> 359 mumol/l for females, > 491 mumol/l for males). Benzbromarone decreased plasma uric acid from 579 + 18 mumol/l to 313 +/- 24 mumol/l (mean +/- SEM; P < 0.0001) and thereby normalized plasma uric acid in 21 of 25 patients. The remaining four patients had creatinine clearances between 21 and 25 ml/min, the lowest of the entire study group. Mean fractional clearance of uric acid increased from 5.4 +/- 0.4% to 17.2 +/- 1.0% (P < 0.001). The relative decrease of plasma uric acid closely correlated with baseline creatinine clearance (r = 0.67; P < 0.001). CsA trough values were not influenced. None of the patients experienced any significant side-effects. As an unexpected find-ing, urinary uric acid excretion increased from 2082 +/- 175 mumol/24 h to 3233 +/- 232 mumol/24 h after 4 weeks' treatment with benzbromarone. In conclusion, benzbromarone normalized plasma uric acid in all CsA-treated renal transplant recipients with a creatinine clearance > 25 ml/min. Due to its excellent efficacy and lack of significant side-effects, benzbromarone appears to be preferable to allopurinol in CsA-treated renal transplant recipients with a creatinine clearance over 25 ml/min. PMID:8090336

  20. Efficacy of a separate informed consent for anesthesia services: A prospective study from the Caribbean

    PubMed Central

    Rampersad, Kavi; Chen, Deryk; Hariharan, Seetharaman

    2016-01-01

    Background and Aims: This study aimed to determine whether a separate written consent form improved the efficacy of the informed consent process for anesthesia in adult patients undergoing elective surgery at a tertiary care teaching hospital. Material and Methods: We randomized patients into two groups prospectively. The first group (Group A) signed the hospital's standard Consent for Operation form only while the second group (Group B) signed a separate Consent for Anesthesia form additionally. Patients were interviewed postoperatively with an eight-item questionnaire with responses in a 5-point Likert scale. A composite adequacy of consent index was generated from the responses and analyzed. Results: Two hundred patients (100 in each group) were studied. All patients indicated that the anesthesiologist(s) had their permission to proceed with their anesthesia care. The mean adequacy of consent index score in Group B was higher than that of Group A (30.6 ± 4.6 [standard deviation (SD)] vs. 27.9 ± 5.2 [SD]) (P < 0.001). The separate written consent had a positive impact on the patients’ understanding of the nature and purpose of the intended anesthesia procedures (P = 0.04), satisfaction with the adequacy of information provided about common side effects (P < 0.001) and rare but serious complications (P = 0.008). Conclusions: A separate written consent for anesthesia improved the efficacy of the informed consent process with respect to better information about the nature and purpose of anesthesia, common side effects, and rare but serious complications. PMID:27006535

  1. 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. PMID:26267600

  2. 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

  3. 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

  4. 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…

  5. Evaluation of Efficacy of Preventive Measures under Hypokinesia.

    ERIC Educational Resources Information Center

    Zorbas, Yan G.; Matveyev, Ivan O.

    1987-01-01

    The study evaluated the efficacy of physical exercise alone and in combination with other preventive measures with 24 adult male subjects kept under a bed rest regime. It was concluded that physical exercise was the most reliable measure in counteracting neuromuscular system disorders under diminished muscular activity conditions. (Author/DB)

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

    PubMed Central

    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. PMID:26989690

  7. Efficacy and safety of propofol sedation during urgent upper gastrointestinal endoscopy--a prospective study.

    PubMed

    Ljubicić, Neven; Supanc, Vladimir; Roić, Goran; Sharma, Mirella

    2003-06-01

    The aim of this study was to investigate both the efficacy and safety of sedation with propofol during urgent therapeutic gastroscopy in patients with upper gastrointestinal bleeding. This prospective study included a total of 110 patients. Propofol was administered intravenously at the starting dose of 1 mg/kg body weight and was followed by repeated doses. Oxygen saturation and heart rate were monitored by pulse oxymetry. The mean dose of propofol administered was 161 +/- 49 mg. Urgent upper GI endoscopy under propofol sedation was successful in 98% of cases. Endoscopists rated the sedation as good in 83.6%, satisfactory in 14.5%, and poor in 1.8% of patients. Potentially harmful drop in oxygen saturation below 85% was observed in 5.5% of patients, whereas a temporary drop in heart rate below 50 beats/min was observed in 11.8%, not requiring any intervention. Almost 93% of patients could not remember the beginning or the end of the intervention. This data demonstrates that sedation with propofol is suitable for use in patients with upper gastrointestinal bleeding undergoing urgent endoscopy. PMID:12974146

  8. Diagnostic efficacy of color Doppler ultrasound in evaluation of cervical lymphadenopathy

    PubMed Central

    Misra, Deepankar; Panjwani, Sapna; Rai, Shalu; Misra, Akansha; Prabhat, Mukul; Gupta, Prashant; Talukder, Subrata K.

    2016-01-01

    Background: To evaluate the efficacy of color Doppler ultrasound (CDUS) in differentiating benign and malignant cervical lymph nodes by detecting differences in blood flow patterns. Materials and Methods: In this cross-sectional prospective study, 25 untreated patients with clinical evidence of cervical lymphadenopathy were evaluated. CDUS was performed for 80 cervical lymph nodes. The gray scale parameters of the lymph node and intranodal perfusion sites were the key CDUS features used to differentiate between reactive and metastatic lymph nodes. Histopathological confirmations were obtained and compared with the results of CDUS. Results: Initially, 53 cervical lymph nodes were evaluated by clinical examination. Twenty-seven additional lymph nodes (53 + 27 = 80) were discovered by CDUS evaluation. Gray scale parameters for lymph nodes such as size of lymph node, shape of lymph node, and presence or absence of hilum revealed highly significant results (P < 0.0001). Color Doppler flow signals revealed that central/hilar flow was characteristic for benign nodes whereas peripheral/mixed flow was characteristic for malignant nodes, the findings were highly significant (P < 0.0001). Gray scale and color Doppler features are used to differentiate benign and malignant nodes. Conclusion: Within the limitations of this study, CDUS evaluation was found to be highly significant with a high sensitivity and specificity over clinical evaluation CDUS examination provides a prospect to reduce the need for biopsy/fine needle aspiration cytology in reactive nodes. PMID:27274341

  9. Intravenous Versus Oral Antibiotic Prophylaxis Efficacy for Elective Laparoscopic Cholecystectomies: a Prospective Randomized Controlled Trial.

    PubMed

    Karaca, A Serdar; Gündoğdu, Haldun; Özdoğan, Mehmet; Ersoy, Eren

    2015-12-01

    The aim of the present prospective randomized controlled trial is to compare the effectiveness of intravenous and oral antibiotic prophylaxis for cost and surgical site infection in elective laparoscopic cholecystectomy. Three hundred twenty patients were split into two groups as to include 160 patients in each, and they were evaluated in a prospective and randomized fashion. While one group was subjected to 1 g cefazolin via intravenous route during anesthesia induction, other group received 1 g cephalexin monohydrate via oral route 1 h prior to the operation. Demographic findings and operation results of the patients were compared by analyses. Our 320 patients (278 females and 42 males) received elective cholecystectomy and were followed up for a period of 6-26 months. Each group had 160 patients. Both groups were similar with regard to demographic characteristics and inclusion criteria. Among all, only five (1.5 %) cases demonstrated postoperative surgical site infection. Surgical site infection at postoperative period was determined in three (1.8 %) cases of intravenous prophylaxis group and two (1.2 %) cases of oral prophylaxis group. There was no statistically significant difference between the groups in terms of surgical site infection. Oral antibiotic prophylaxis can be used in elective laparoscopic cholecystectomy prophylaxis due to its cost-effective, reliable nature, and low surgical site infection rate. PMID:26730079

  10. Efficacy evaluations on five chlorhexidine teat dip formulations.

    PubMed

    Drechsler, P A; O'Neil, J K; Murdough, P A; Lafayette, A R; Wildman, E E; Pankey, J W

    1993-09-01

    Three developmental postmilking teat dip formulations containing chlorhexidine digluconate were evaluated against Staphylococcus aureus and Streptococcus agalactiae in sequential experimental exposure trials. Two additional commercial chlorhexidine digluconate teat dip products were evaluated in natural exposure trials. Under conditions of experimental challenge, the developmental formulations were efficacious against Staph. aureus but did not significantly reduce incidence of new IMI by Strep. agalactiae. None of the three formulations of a conventional germicide used as teat sanitizers effectively reduced incidence of new Strep. agalactiae IMI under experimental challenge conditions. In the natural exposure trials with negative controls, a .35% chlorhexidine teat sanitizer had efficacy of 88.7% against Staph. aureus and 51.4% against Strep. agalactiae. The .5% chlorhexidine product reduced Staph. aureus and Strep. agalactiae IMI by 86 and 56%, respectively. PMID:8227681

  11. 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…

  12. 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…

  13. 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

  14. 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

  15. The Effect of Prospective Teachers' Problem Solving Beliefs on Self-Efficacy Beliefs about Mathematical Literacy

    ERIC Educational Resources Information Center

    Memnun, Dilek Sezgin; Akkaya, Recai; Haciomeroglu, Guney

    2012-01-01

    This study examines prospective teachers' beliefs in their own abilities and effectiveness to impart mathematical literacy to their students, their beliefs about mathematical problem solving, and the relationship between these two belief systems. A total of 567 prospective teachers, majoring in mathematics, science and elementary teacher education…

  16. A randomized prospective study to assess the efficacy of two cold-therapy treatments following carpal tunnel release.

    PubMed

    Hochberg, J

    2001-01-01

    A prospective randomized study was performed comparing the efficacy of controlled cold therapy (CCT) with the efficacy of ice therapy in the postoperative treatment of 72 patients with carpal tunnel syndrome. Immediately after surgery, patients applied either a temperature-controlled cooling blanket (CCT) or a standard ice pack over their surgical dressings. Pain was assessed by visual analog scale and swelling by wrist circumference preoperatively, immediately after surgery, and on postoperative day 3. Patients kept log books of daily treatment times. Narcotic use (of Vicodin ES) was determined by pill count at day 3 and by daily log book recordings. Patients who used CCT showed significantly greater reduction in pain, edema (wrist circumference), and narcotic use at postoperative day 3 than did those using ice therapy. This study indicates that after carpal tunnel surgery, the use of CCT, compared with traditional ice therapy, provides patients with greater comfort and lessens the need for narcotics. PMID:11511016

  17. Changes in Self-Efficacy of Prospective Special and General Education Teachers: Implication for Inclusive Education

    ERIC Educational Resources Information Center

    Leyser, Yona; Zeiger, Tali; Romi, Shlomo

    2011-01-01

    The impact of three variables on the self-efficacy of 992 general and special education preservice teachers was examined. These variables were years of preservice education, experience with children with special educational needs, and training in inclusion or exceptional education. All participants responded to a teacher self-efficacy scale that…

  18. 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…

  19. Comparative Analysis of Expectancies of Efficacy in In-Service and Prospective Teachers

    ERIC Educational Resources Information Center

    de la Torre Cruz, Manuel J.; Casanova Arias, Pedro F.

    2007-01-01

    This study examines the beliefs about effective teaching in student teachers and inservice teachers. We constructed a measurement composed of an adaptation in Spanish of the Gibson and Dembo's (1984. Teacher efficacy: A construct validation. "Journal of Educational Psychology", 76, 569-582). Teacher Efficacy Scale and of the items included in…

  20. 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…

  1. 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

  2. Healthy-eater identity and self-efficacy predict healthy eating behavior: a prospective view.

    PubMed

    Strachan, Shaelyn M; Brawley, Lawrence R

    2009-07-01

    Identity and Self-efficacy Theories were used to examine the relationship between healthy-eater identity, self-efficacy for healthy eating and healthy eating. Measures of healthy-eater identity, perception of healthy eating, nutrition knowledge, self-efficacy for both intake of fruits and vegetables and foods of low nutritional value were completed by 101 university students and staff. Two weeks later, participants recalled recent consumption of (a) fruits and vegetables and (b) foods of low nutritional value. For both eating outcomes, healthy-eater identity was a significant predictor after controlling for nutrition knowledge. The addition of self-efficacy improved prediction in the case of both eating outcomes. PMID:19515684

  3. Efficacy of Clopidogrel and Clinical Outcome When Clopidogrel Is Coadministered With Atorvastatin and Lansoprazole: A Prospective, Randomized, Controlled Trial.

    PubMed

    Zhang, Jian-rong; Wang, Di-qing; Du, Jun; Qu, Guang-su; Du, Jian-lin; Deng, Song-bai; Liu, Ya-jie; Cai, Jin-xi; She, Qiang

    2015-12-01

    This prospective, randomized, nonblind, controlled trial evaluated the effects of clopidogrel on platelet function upon coadministration with atorvastatin and lansoprazole. One hundred four adult patients with non-ST-segment elevated acute coronary syndrome (NSTE-ACS) who underwent percutaneous coronary intervention (PCI) with drug-eluting stent implantation were included. All patients were treated with standard dual antiplatelet therapy (DAPT) plus rosuvastatin 10  mg daily after the operation. On the sixth day after PCI, patients were randomly divided into 4 groups, Group A: DAPT + atorvastatin 20  mg daily (a change from rosuvastatin to atorvastatin) + lansoprazole 30  mg daily, Group B: DAPT + atorvastatin 20  mg daily (a change from rosuvastatin to atorvastatin), Group C: DAPT + lansoprazole 30  mg daily (continuing to take rosuvastatin), Group D is the control group. Additional drugs were used according to the situation of patients. Platelet function and concentrations of platelet activation markers (granular membrane protein 140 (P-selectin), thromboxane B2 (TXB2), and human soluble cluster of differentiation 40 ligand (sCD40L)) were assessed before randomization and at 15- and 30-day follow-up visits. All patients were maintained on treatment for 6 months and observed for bleeding and ischemic events. A total of 104 patients were enrolled, 27 patients in group A, 26 patients in Group B/C, 25 patients in Group D separately, and all the patients were analyzed. There were no differences in platelet function and the levels of platelet activation markers (P-selectin, TXB2, and sCD40L) among or within the 4 groups at the 3 time points of interest (P > 0.05). In the subsequent 6 months, no significant bleeding events occurred, and 12 patients experienced ischemic events, these results were also not significantly different among the groups (P > 0.05). In patients diagnosed with NSTE-ACS who have had drug-eluting stent implantation

  4. Prospective evaluation of syndesmotic ankle sprains without diastasis.

    PubMed

    Nussbaum, E D; Hosea, T M; Sieler, S D; Incremona, B R; Kessler, D E

    2001-01-01

    Sixty consecutive collegiate athletes with "high" ankle symptoms were prospectively evaluated over a 3-year period in an effort to better define this debilitating ankle injury. All athletes included in this study had tenderness over the distal anterior tibiofibular ligament, tenderness proximally along the interosseous membrane, and functional disability. No study subject had a fracture or frank tibia-fibula diastasis. The severity of the sprain was quantified using the interosseous "tenderness length." A standard rehabilitation protocol was followed by all patients. Athletes returned to competition when they could perform all functional testing without difficulty. Time to return to full competitive activity averaged 13.4 days. The number of days missed from competition was statistically related to the interosseous tenderness length (P = 0.0001) and to positive results on the squeeze test (P = 0.03). Fifty-three of the 60 injured athletes were evaluated at least 6 months after injury. Patients rated their outcomes as good or excellent. Six of the patients experienced occasional ankle pain and stiffness, four patients reported recurrent ankle sprains, and one patient had heterotopic ossification formation. PMID:11206253

  5. A prospective evaluation of outcomes of two tapered implant systems.

    PubMed

    Andreasi Bassi, M; Lopez, M A; Confalone, L; Gaudio, R M; Lombardo, L; Lauritano, D

    2016-01-01

    The purpose of this prospective clinical study was to evaluate survival rate (SVR - i.e. fixtures still in place at the end of the observation period) and success rate (SCR - i.e. bone resorption around the implant neck) of two tapered implant systems. Both systems were equipped with a tapered connection, one requiring bone-level (BL) placement, while the other required soft-tissue-level (STL) placement. In the period between January 1996 and October 2011, 133 fixtures were inserted, 90 in females and 43 in males, with a mean age of 60±11 years. The mean post-surgical follow-up was 64±38 months. Several clinical parameters were evaluated as potential outcome conditioners. An SPSS program was used for statistical analysis and a Cox analysis was performed. The SVR was 100% since no fixtures were lost. SCR, expressed through the mean marginal bone loss, was 88%. No significant differences were found, for most of the variables investigated with the exception of bone grafting and implant type: STL implants showed a better clinical outcome than BL implants when bone grafting was performed simultaneously with implant placement. Tapered implants are reliable devices for oral rehabilitation of jaws. PMID:27469541

  6. Rationale and design of a clinical trial of a low-molecular-weight heparin in preventing clinically important venous thromboembolism in medical patients: the prospective evaluation of dalteparin efficacy for prevention of venous thromboembolism in immobilized patients trial (the PREVENT study).

    PubMed

    Vaitkus, Paul T; Leizorovicz, A; Goldhaber, S Z

    2002-01-01

    The utility of low-molecular-weight heparin (LMWH) in the prophylaxis of venous thromboembolic disease has been examined using the surrogate endpoint of venographically identified thrombi. The largest portion of these thrombi were asymptomatic calf-vein thrombi. The clinical relevance of this observation is a matter of debate. The present study is designed to evaluate the impact of an LMWH on clinically important endpoints. The current study is a randomized, prospective, double-blinded, multicenter, multinational, controlled clinical trial comparing dalteparin with placebo in moderately high-risk hospitalized medical patients. A total of 3300 patients will be randomized to receive either 5,000 IU per day of dalteparin or placebo for 14 days. Patients will undergo appropriate evaluation for any symptomatic episodes and all patients will undergo a bilateral compression ultrasound (CUS) on day 21 to search for asymptomatic proximal thrombi. The primary endpoint is the combination of objectively confirmed symptomatic deep vein thrombi (DVT), fatal or non-fatal pulmonary emboli, all proximal DVT, and sudden death. This study will be the first study to examine clinically important endpoints in evaluating the effect of a LMWH in hospitalized medical patients. This study also is the first study to use CUS rather than venography in concordance with contemporary medical practice. This trial is thus designed to address this important question in a clinically relevant manner. PMID:12710842

  7. Efficacy Evaluation of an Inactivated Duck Tembusu Virus Vaccine.

    PubMed

    Lin, Jian; Liu, Yuehuan; Wang, Xiuqing; Yang, Baoshou; He, Pingyou; Yang, Zhiyuan; Duan, Huijuan; Xie, Jia; Zou, Lihong; Zhao, Jicheng; Pan, Jie

    2015-06-01

    To evaluate the potential use of an inactivated virus-based vaccine for the control and prevention of the newly emerged duck Tembusu virus infection in China, a duck Tembusu virus isolate, Tembusu-HB, was propagated in 12-day-old duck embryos and inactivated by treatment with formaldehyde. The inactivated viral antigen was emulsified with mineral oil, and five batches of the vaccine were manufactured. The immunogenicity and protection efficacy of the vaccine were evaluated in Beijing ducks and Beijing white geese. Results showed that more than 80% of immunized ducks were protected against virulent virus challenge after two intramuscular or subcutaneous injections of the inactivated vaccine, as evidenced by the negative virus isolation results. The protection is also correlated with a positive virus-specific antibody response as detected by ELISA. In contrast, none of the control ducks and geese had any detectable antibody response. Virus was isolated from all control ducks and geese after virulent virus challenge. Interestingly, a variable level of protection (20%-80%) was observed in Beijing white geese immunized twice with the same batches of vaccine, suggesting a species-specific effect of the vaccine. Overall, the results clearly suggest that the inactivated duck Tembusu virus vaccine is immunogenic and provides protection against virulent virus challenge. PMID:26473674

  8. 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

  9. 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…

  10. Evaluation and outcome of antenatal hydronephrosis: a prospective study.

    PubMed

    Gökaslan, Filiz; Yalçınkaya, Fatoş; Fitöz, Suat; Özçakar, Z Birsin

    2012-01-01

    Antenatal hydronephrosis (AHN), defined as dilatation of renal pelvis and/or calyces, is the most frequently detected antenatal abnormality. However, postnatal management of AHN is controversial. The purpose of this study was to describe the clinical outcomes of infants with AHN and to contribute to the definition of the postnatal evaluation of these patients. One hundred and thirty-six infants with AHN were prospectively followed up to 18 months. Patients were divided into two groups according to the degree of sonographic hydronephrosis (HN) on days 5-7: group I (n = 87, 64%) included patients who had grades 1 and 2 (64%) and group II (n = 49, 36%) included patients who had grade 3 and above HN. The grade of HN was found to be correlated with the increased risk of urologic pathologies. Frequency of vesicoureteral reflux was found to be significantly lower in patients with mild HN (6%) as compared to patients with severe AHN (29%) (p = 0.005). In addition, the risk of urinary tract infection increases with increasing grades of HN (10% vs. 29%, p = 0.006). The frequency of spontaneous resolution in patients with mild AHN (64%) was also significantly higher than in patients with severe HN (29%) (p < 0.001). The degree of AHN can be used for making decision about further diagnostic imaging and treatment. Our results strongly suggest that low-grade HN is a relatively self-limited condition and needs minimal investigation. In contrast, the outcome of more severe degrees of AHN needs clarification. PMID:22506510

  11. Specialized Pediatric Palliative Home Care: A Prospective Evaluation

    PubMed Central

    Borasio, Gian Domenico; Nickolay, Carla; Bender, Hans-Ulrich; von Lüttichau, Irene; Führer, Monika

    2013-01-01

    Abstract Objectives: In Germany since 2007 children with advanced life-limiting diseases are eligible for Pediatric Palliative Home Care (PPHC), which is provided by newly established specialized PPHC teams. The objective of this study was to evaluate the acceptance and effectiveness of PPHC as perceived by the parents. Methods: Parents of children treated by the PPHC team based at the Munich University Hospital were eligible for this prospective nonrandomized study. The main topics of the two surveys (before and after involvement of the PPHC team) were the assessment of symptom control and quality of life (QoL) in children; and the parents' satisfaction with care, burden of patient care (Häusliche Pflegeskala, home care scale, HPS), anxiety and depression (Hospital Anxiety and Depression Scale, HADS), and QoL (Quality of Life in Life-Threatening Illness–Family Carer Version, QOLLTI-F). Results: Of 43 families newly admitted to PPHC between April 2011 and June 2012, 40 were included in the study. The median interval between the first and second interview was 8.0 weeks. The involvement of the PPHC team led to a significant improvement of children's symptoms and QoL (P<0.001) as perceived by the parents; and the parents' own QoL and burden relief significantly increased (QOLLTI-F, P<0.001; 7-point change on a 10-point scale), while their psychological distress and burden significantly decreased (HADS, P<0.001; HPS, P<0.001). Conclusions: The involvement of specialized PPHC appears to lead to a substantial improvement in QoL of children and their parents, as experienced by the parents, and to lower the burden of home care for the parents of severely ill children. PMID:24168349

  12. 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

  13. A Professional Development Program Evaluation: Teacher Efficacy, Learning, and Transfer

    ERIC Educational Resources Information Center

    Tomonari, Dana Anne Miyuki

    2012-01-01

    Although professional development is an important means of improving both teachers' skills and student outcomes, there is a dearth of high quality empirical research on the efficacy of such efforts. The efficacy of the Challenging Behavior Process was assessed using a mixed method approach which included the use of pre-, post-, and follow-up…

  14. 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…

  15. 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

  16. 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

    2011-01-01

    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 (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. PMID:21572951

  17. 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.

  18. The HIV Medication Taking Self-Efficacy Scale: Psychometric Evaluation

    PubMed Central

    Erlen, Judith A.; Cha, EunSeok; Kim, Kevin H.; Caruthers, Donna; Sereika, Susan M.

    2010-01-01

    Aim This paper is a report of an examination of the psychometric properties of the HIV Medication Taking Self-efficacy Scale. Background Self-efficacy is a critically important component of strategies to improve HIV medication-taking; however, valid and reliable tools for assessing HIV medication-taking self-efficacy are limited. Method We used a cross-sectional, correlational design. Between 2003 and 2007, 326 participants were recruited from sites in Pennsylvania and Ohio in the United States of America. Six self-report questionnaires administered at baseline and 12 weeks later during “Improving Adherence to Antiretroviral Therapy” were used to examine the variables of interest. Means and variances, reliability, criterion, and construct validity of the HIV Medication Taking Self-efficacy Scale were assessed. Findings Participants reported high self-confidence in their ability to carry out specific medication-related tasks (mean=8.31) and in the medication’s ability to effect good outcomes (mean=8.56). The HIV Medication Taking Self-efficacy Scale and subscales showed excellent reliability (α = .93 ~ .94). Criterion validity was well-established by examining the relationships between the HIV Medication Taking Self-efficacy Scale and selected physiological and psychological factors, and self-reported medication adherence (r = −.20 ~ .58). A two-factor model with a correlation between self-efficacy belief and outcome expectancy fitted the data well (model χ2 = 3871.95, df = 325, p<001; CFA =.96; RMSEA =.046). Conclusion The HIV Medication Taking Self-efficacy Scale is a psychometrically sound measure of medication-taking self-efficacy for use by researchers and clinicians with people with HIV. The findings offer insight into the development of interventions to promote self-efficacy and medication adherence in persons with HIV. PMID:20722799

  19. 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

  20. 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.

  1. 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)

  2. 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

  3. Evaluating Prospects: The Criteria Used to Hire New Teachers

    ERIC Educational Resources Information Center

    Cranston, Jerome

    2012-01-01

    Teacher hiring decisions have far-reaching effects. Accordingly, it is important that prospective teachers be scrutinized carefully. The process that yields new teacher hires also deserves careful analysis. This article reports on key findings derived from a larger study that examined the overall organization of the hiring process and how criteria…

  4. Efficacy and safety of hydrostatic balloon dilatation of ileocolonic Crohn's strictures: a prospective longterm analysis.

    PubMed Central

    Couckuyt, H; Gevers, A M; Coremans, G; Hiele, M; Rutgeerts, P

    1995-01-01

    Preliminary reports have suggested that dilatation using hydrostatic through the scope balloons may be useful for the treatment of Crohn's strictures, A prospective longterm follow up (mean (SD) 33.6 (11.2) months) was carried out in 55 Crohn's patients with 59 ileocolonic strictures submitted to 78 dilatation procedures. Hydrostatic balloons were used (Rigiflator, Microvasive) with a diameter of 18 mm on inflation. As soon as the balloons became available dilatation up to a diameter of 20 and 25 mm was attempted. The dilatations were performed under general anaesthesia using propofol (Diprivan). The patients were kept for one night in the hospital after dilatation. Seventy (90%) procedures were technically successful and passage of the stricture with a 13.6 mm diameter colonoscope was possible after 73% of the dilatations. Complications occurred in six patients (11%; 8% of procedures), including sealed perforations (n = 2), retroperitoneal perforations (n = 2), and intraperitoneal perforations (n = 2). Two of the patients were treated surgically with a one stage resection of the stricture and recovered uneventfully. Four patients were treated conservatively with intravenous fluids and antibiotics. There was no mortality. Dilatation completely relieved obstructive symptoms in 20 patients after one procedure, in another 14 patients after two (n = 13) or three (n = 1) dilatations. Total longterm success rate was 34 of 55 patients (62%). Nineteen patients (38%) were operated on because of persistent obstructive symptoms. The data show that endoscopic dilatation using the through the scope hydrostatic balloon system relieves obstructive symptoms resulting from ileocolonic Crohn's strictures. The procedure, however, carries a definite risk of perforation. PMID:7737567

  5. Efficacy and safety of hydrostatic balloon dilatation of ileocolonic Crohn's strictures: a prospective longterm analysis.

    PubMed

    Couckuyt, H; Gevers, A M; Coremans, G; Hiele, M; Rutgeerts, P

    1995-04-01

    Preliminary reports have suggested that dilatation using hydrostatic through the scope balloons may be useful for the treatment of Crohn's strictures, A prospective longterm follow up (mean (SD) 33.6 (11.2) months) was carried out in 55 Crohn's patients with 59 ileocolonic strictures submitted to 78 dilatation procedures. Hydrostatic balloons were used (Rigiflator, Microvasive) with a diameter of 18 mm on inflation. As soon as the balloons became available dilatation up to a diameter of 20 and 25 mm was attempted. The dilatations were performed under general anaesthesia using propofol (Diprivan). The patients were kept for one night in the hospital after dilatation. Seventy (90%) procedures were technically successful and passage of the stricture with a 13.6 mm diameter colonoscope was possible after 73% of the dilatations. Complications occurred in six patients (11%; 8% of procedures), including sealed perforations (n = 2), retroperitoneal perforations (n = 2), and intraperitoneal perforations (n = 2). Two of the patients were treated surgically with a one stage resection of the stricture and recovered uneventfully. Four patients were treated conservatively with intravenous fluids and antibiotics. There was no mortality. Dilatation completely relieved obstructive symptoms in 20 patients after one procedure, in another 14 patients after two (n = 13) or three (n = 1) dilatations. Total longterm success rate was 34 of 55 patients (62%). Nineteen patients (38%) were operated on because of persistent obstructive symptoms. The data show that endoscopic dilatation using the through the scope hydrostatic balloon system relieves obstructive symptoms resulting from ileocolonic Crohn's strictures. The procedure, however, carries a definite risk of perforation. PMID:7737567

  6. 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. PMID:25641421

  7. Efficacy and safety of flupirtine maleate and tramadol hydrochloride in postoperative pain management--a prospective randomised double blinded study.

    PubMed

    Naser, Syed Mohammed; Sarkar, Niladri; Biswas, Arunava; Kamal, Firdaus; Prakash, Raghu; Rahaman, Q M; Das, Anup Kumar

    2012-03-01

    The study was conducted to evaluate the efficacy and safety of flupirtine maleate 100 mg thrice daily compared to tramadol hydrochloride 50 mg thrice daily as postoperative pain management for 5 days. A total of 113 postoperative patients were recruited for the study. Those who met the inclusion criteria (n = 104) were randomised into two treatment groups. One of the groups received flupirtine maleate and the other tramadol hydrochloride both orally. The pain intensity was assessed by visual analogue scale. Patients were informed to report any adverse effect encountered during the study period. The overall effect of the drug (global assessment of the study medication) on pain and side-effects was assessed by the patients at the end of the trial on a categorical scale. There was significant reduction in pain score (p < 0.001) in the flupirtine group with almost equal efficacy to that of tramadol group but the incidence of adverse effects were much less (7.4%) and didn't need discontinuation of the study. All drugs were assessed as good. Therefore it can be concluded that oral flupirtine can deliver the same analgesic efficacy as oral tramadol for postoperative pain relief, which might be beneficial for avoiding the adverse effects ofopioids and non-steroidal anti-inflammatory drug therapy. PMID:23029946

  8. A prospective multicenter clinical trial to assess safety and efficacy of Menicon SF-P RGP lenses for extended wear.

    PubMed

    MacKeen, D L; Sachdev, M; Ballou, V; Cavanagh, H D

    1992-07-01

    A prospective, multicenter, national clinical trial was undertaken to assess the safety and efficacy of Menicon SF-P (melafocon A) rigid gas permeable (RGP) contact lenses for extended wear in healthy human eyes. Ten investigators enrolled 167 patients (334 eyes), of which 143 (286 eyes) were initially fit with lenses for the 12-month study. Most subjects were reexamined at 18 months or more, with findings essentially unchanged from those noted at 1 year. Two hundred-two eyes (71%) completed the study. Seventy-two eyes (25%) discontinued, and 12 (4%) elected to continue extended wear. During the study, no significant adverse clinical reaction attributable to the lens was observed. Surface irritation, occasional punctate staining, and lens binding were very rare. The average wearing time was 6.2 days, mandated partially by FDA restrictions as well as patient response. As expected, keratometric shifts were principally vertical: less than 0.99 D (69%), 1.00-1.99 D (28%), and 2.00-2.99 D (4%). The majority of changes observed were toward sphericity. Two hundred lens replacements were required, 24% for adjustments in power/base curve. Only 16 lenses were replaced for warpage, and none for discoloration or crazing. Of those completing the study, 76% rated overall lens comfort and satisfaction to be very good. These results suggest that RGP lens extended wear can be safe and effective and offer patients an acceptable alternative to extended wear of disposable hydrogel lenses. PMID:1499126

  9. Anti-inflammatory efficacy of low-dose cyclosporin A in psoriatic arthritis. A prospective multicentre study.

    PubMed

    Mahrle, G; Schulze, H J; Bräutigam, M; Mischer, P; Schopf, R; Jung, E G; Weidinger, G; Färber, L

    1996-11-01

    Fifty-five patients with psoriatic arthritis were treated with a low dose of cyclosporin A (CyA) (mean dose 2.7 mg/kg per day) for a period of 6 months to investigate the efficacy of CyA on disease parameters. Significant improvement in the joint complaints and inflammation parameters was observed including a decrease in the number of painful (-46%) and swollen (-45%) joints, tenderness (Ritchie Index: -50%) and degree of swelling (-46%), patient's assessment of pain (-35%), the duration of morning joint stiffness (-37%), as well as a decrease in C-reactive protein (-52%). A 50% reduction of joint complaints required a total of 24 weeks, whereas a 50% reduction of skin involvement was achieved after 5-6 weeks of treatment. Four patients left the study due to adverse events: creatinine level increase in two patients, hypertension in one patient and gastroenteritis in the fourth patient. Joint scintigraphy in 18 patients indicated an improvement or stable condition in 61% of cases after a mean follow-up of approximately 8 months. The results of this prospective study show that low-dose CyA effectively improves not only skin lesions, but also joint complaints in psoriatic arthritis. PMID:8977676

  10. 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. PMID:25214469

  11. EVOLVE (nebivolol evaluation for efficacy and safety in the treatment of hypertension) postmarketing surveillance study.

    PubMed

    Faruqui, Arif A

    2007-05-01

    The objective of EVOLVE [nebivolol (nevol) evaluation for efficacy and safety in the treatment of hypertension], a postmarketing surveillance (PMS) study is to identify, validate and quantify the safety and efficacy associated with the use of nebivolol. EVOLVE study was an open-label, non-comparative, prospective, one month follow-up study of 301 patients of either sex with stage 1 hypertension, as defined by the JNC VII guidelines. The data was collected from 27 centres from all over India during the period August, 2006 to December, 2006. Nebivolol (2.5-5 mg/day) was given for 1 month. Clinical assessment was done at the start of the treatment and at 15th day and 30th day follow-ups. Concomitant medications administered were also recorded. Baseline mean systolic blood pressure (SBP) was 157.73 +/- 14.16 mm Hg which dropped to 135.13 +/- 11.15 mm Hg at the end of the study. At the end of 1 month treatment the change in mean SBP was 22.6 mm Hg ie, 14.32% reduction from baseline which was statistically significant (p < 0.001). Also the baseline mean diastolic blood pressure (DBP) was 97.21 +/- 8.25 mm Hg that dropped to 83.69 +/- 6.63 mm Hg at the end of the study. At the end of one month treatment the change in mean DBP was 13.52 mmHg ie, 13.9% reduction from baseline which was significant (p < 0.001). The heart rate in this study showed a significant decrease from 86.13 +/- 9.35 at basal to 75.09 +/- 7.42 at the end of the study (p < 0.001). It was observed that at the end of one month of treatment, majority of the patients ie, 97.75% of total cases showed good to excellent response to nebivolol. EVOLVE PMS study showed that nebivolol hydrochloride is very safe and only 8.2% of cases (n = 22) reported adverse effects, the commonest being dizziness (3.28%). Less than 1% patients reported nausea, constipation, headache, weakness, tiredness and pedal oedema; 99.25% of patients reported good to excellent tolerability; 82.33% patients achieved the goals recommended by

  12. Efficacy and safety of subcutaneous vivaglobin® replacement therapy in previously untreated patients with primary immunodeficiency: a prospective, multicenter study.

    PubMed

    Borte, Michael; Quinti, Isabella; Soresina, Annarosa; Fernández-Cruz, Eduardo; Ritchie, Bruce; Schmidt, Dirk S; McCusker, Christine

    2011-12-01

    Treatment of primary immunodeficiency (PI) is typically initiated with intravenous immunoglobulin (IVIG) loading and then continued with IVIG or subcutaneous IgG (SCIG). This prospective, open-label, multicenter, 6-month study evaluated a new regimen of initiating IgG therapy with SCIG in 18 previously untreated patients. In the loading phase, SCIG 100 mg/kg was administered for five consecutive days (total loading dose 500 mg/kg). During the maintenance phase, patients self-infused SCIG 100 mg/kg/week at home. The primary efficacy endpoint of IgG levels ≥5 g/L on day 12 was achieved in 17 patients (94.4%; 95% CI 0.727, 0.999). The rate of infections was 3.95 episodes/patient/year. Improvement was found in many subscales of the health-related quality of life questionnaires. SCIG treatment was well tolerated, with no related serious adverse events (AEs). Nine (50%) patients experienced related AEs, including local reactions (rate 0.105 events/infusion). The results suggest that therapy of newly diagnosed patients with PI can be initiated directly with SCIG. PMID:21932110

  13. The Efficacy and Safety of Jaungo, a Traditional Medicinal Ointment, in Preventing Radiation Dermatitis in Patients with Breast Cancer: A Prospective, Single-Blinded, Randomized Pilot Study

    PubMed Central

    Kong, Moonkyoo; Hwang, Deok-Sang; Lee, Jee Young; Yoon, Seong Woo

    2016-01-01

    Purpose. This study was performed to evaluate the efficacy and safety of Jaungo in preventing radiation dermatitis in patients with breast cancer. Methods. Thirty patients were prospectively enrolled and randomly assigned to receive Jaungo or general supportive skin care. Radiation dermatitis and pain were examined at daily intervals from the start of radiotherapy until 4 weeks after its completion. The primary endpoint of this study was the incidence of radiation dermatitis. The secondary endpoints were time to onset of radiation dermatitis, duration of radiation dermatitis, and maximum pain score. Results. Jaungo reduced the incidence of grade ≥2 (46.7% versus 78.6%) and grade 3 radiation dermatitis (20.0% versus 50.0%) in comparison with general supportive skin care. Jaungo also delayed the onset of grade 2 dermatitis (35 days versus 30 days). In terms of time to onset of grade 3 dermatitis, duration of dermatitis, and maximum pain score, Jaungo showed results comparable to those achieved with general supportive skin care. No patients experienced adverse effects caused by Jaungo administration. Conclusions. Jaungo minimized radiation dermatitis in patients with breast cancer without causing adverse effects. Further randomized studies with a larger sample size are required to assess clinical use of Jaungo. PMID:27066103

  14. 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…

  15. Efficacy and safety of finasteride therapy for benign prostatic hyperplasia: results of a 2-year randomized controlled trial (the PROSPECT study). PROscar Safety Plus Efficacy Canadian Two year Study.

    PubMed Central

    Nickel, J C; Fradet, Y; Boake, R C; Pommerville, P J; Perreault, J P; Afridi, S K; Elhilali, M M

    1996-01-01

    OBJECTIVE: To evaluate the efficacy and safety of 2 years' treatment of moderate benign prostatic hyperplasia (BPH) with finasteride. DESIGN: Double-blind, parallel-group, placebo-controlled, multicentre, prospective randomized study. SETTING: Outpatient care in 28 centres across Canada. PARTICIPANTS: Men aged 45 to 80, in good health, with moderate BPH and no evidence of prostate cancer. A total of 613 men were entered into the study; 472 completed the 2 years of treatment. INTERVENTION: After 1 month of receiving a placebo (run-in period), patients were given either finasteride (5 mg/d) or a placebo for 2 years. OUTCOME MEASURES: Efficacy: changes from baseline in BPH symptom scores, maximum urinary flow rates and prostate volume. Safety: onset, course and resolution of all adverse events during the treatment period. RESULTS: In the efficacy analyses the mean BPH symptom scores decreased 2.1 points (from 15.8 to 13.7) in the finasteride group, as compared with a decrease of 0.7 points (from 16.6 to 15.9) in the placebo group (P < or = 0.01). The maximum urinary flow rate increased by a mean of 1.4 mL/s (from 11.1 to 12.5 mL/s) in the finasteride group, as compared with an increase of 0.3 mL/s (from 10.9 to 11.2 mL/s) in the placebo group (p < or = 0.01). The mean prostate volume decreased by 21% (from a mean volume of 44.1 cm3 at baseline) in the treatment group; it increased by 8.4% (from a mean volume of 45.8 cm3 at baseline) in the placebo group (p < or = 0.01). In the safety analysis, the proportion of patients who experienced any adverse event was similar in the two groups (81.0% in the treatment group and 81.2% in the placebo group). However, the incidence of adverse events related to sexual dysfunction were significantly higher in the finasteride group than in the placebo group (ejaculation disorder 7.7% v. 1.7% and impotence 15.8% v. 6.3%; p < or = 0.01 for both parameters). CONCLUSION: Finasteride is a well-tolerated and effective alternative to watchful

  16. Multiple Sclerosis Therapy With Disease-Modifying Treatments in Germany: The PEARL (ProspEctive phArmacoeconomic cohoRt evaluation) Noninterventional Study Protocol

    PubMed Central

    Vormfelde, Stefan Viktor; Ortler, Sonja

    2016-01-01

    Background Patients with multiple sclerosis (MS) require long-term therapy and have a wide variety of needs for health-related support. The efficacy and safety of MS therapy, as assessed by both clinicians and patients, are important parameters that need to be considered. However, few studies combine data on efficacy and safety outcomes with pharmacoeconomic data. Objective Here, we present the study design of the ProspEctive phArmacoeconomic cohoRt evaluation (PEARL), a prospective, multicenter, noninterventional cohort study on patients with relapsing-remitting MS (RRMS) treated with disease-modifying treatments (DMTs). Methods During a prospective observational phase of 24 months per patient, PEARL evaluated clinical and patient-perceived efficacy and safety measures, as well as pharmacoeconomic data on RRMS patients treated with DMTs—interferon beta and glatiramer acetate. Measurements of the patients' perceptions included the assessment of patient-reported quality of life, treatment satisfaction, and compliance. The study was planned to include 1800 outpatients from 180 German neurological practices who had continuously been treated with an approved DMT for at least 30 days. The primary statistical analyses of the PEARL study will be descriptive. Particular focus will be on specific subgroups, such as patients who switched DMTs during therapy and patients with disease worsening or disease activity. Subgroups will be compared using stratified analyses. Results Data collection for PEARL started in September 2010 and ended in July 2013. As of July 2015, the study is completed and is currently being analyzed and written up. Conclusions PEARL is evaluating both the health status and resource utilization of RRMS patients treated with DMTs in Germany. The combination of pharmacoeconomic data with clinical and patients' self-perceived efficacy and safety outcomes will add useful information to the currently incomplete picture of the overall RRMS burden in Germany

  17. 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

  18. 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

  19. Long-term Efficacy of Trabeculectomy on Chinese Patients with Pigmentary Glaucoma: A Prospective Case Series Observational Study

    PubMed Central

    Qing, Guo-Ping; Wang, Ning-Li; Wang, Tao; Chen, Hong; Mou, Da-Peng

    2016-01-01

    Background: Though trabeculectomy is often performed on patients with medically refractive pigmentary glaucoma (PG), the clinical outcomes of surgical treatment on PG remain unknown. The aim of this study was to summarize the long-term efficacy and safety of trabeculectomy on PG. Methods: This was a prospective case series observational study. Eighteen consecutive PG patients were followed up for 8 years after trabeculectomy from May 2006 to April 2007. Visual acuity (VA), best-corrected visual acuity (BCVA), slit lamp biomicroscopy, intraocular pressure (IOP) measurement, Humphrey visual field analysis (VFA), and stereoscopic funduscopy were performed on admission and every 6 months after the surgery. Postoperative IOP, VA, BCVA, VFA, adjunctive anti-glaucoma medication, treatment-related side-effects, changes in blebs, and main clinical findings in the anterior segment of PG were recorded and compared with the baseline. Results: Eighteen PG eyes from 18 patients, with average preoperative IOP of 34.5 ± 4.7 mmHg (range: 21–47 mmHg, 1 mmHg=0.133 kPa) were enrolled in this study. All enrolled patients completed the follow-up visits and required examinations. Eight years after trabeculectomy, all surgical eyes (18/18) had satisfactory IOP control with an average of 13.7 ± 2.5 mmHg (range: 9–19 mmHg), which was significantly lower than baseline (P = 0.001). Majority (15/18) of the PG eyes had stable VA, BCVA, VFA, and optic disc cupping parameters. Functional blebs still existed in 12/18 of the PG eyes at the last follow-up visit. Unanimously, pigmentation in the anterior segment attenuated with time after surgical treatment. No severe side-effects were recorded in any of the surgical eyes. Conclusions: All surgical PG eyes in this study had satisfactory IOP control 8 years after the surgery with well-preserved visual function. The long-term efficacy and safety of trabeculectomy are promising in PG patients. PMID:27231161

  20. 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

  1. 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

  2. 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…

  3. Therapy of Hypoparathyroidism with PTH(1–84): A Prospective Four-Year Investigation of Efficacy and Safety

    PubMed Central

    Cusano, Natalie E.; Rubin, Mishaela R.; McMahon, Donald J.; Zhang, Chiyuan; Ives, Rebecca; Tulley, Amanda; Sliney, James; Cremers, Serge C.

    2013-01-01

    Context: PTH may be an effective treatment option for hypoparathyroidism, but long-term data are not available. Objective: We studied the effect of 4 yr of PTH(1–84) treatment in hypoparathyroidism. Design: Twenty-seven subjects were treated with PTH(1–84) for 4 yr, with prospective monitoring of calcium and vitamin D requirements, serum and urinary calcium, serum phosphorus, bone turnover markers, and bone mineral density (BMD). Results: Treatment with PTH(1–84) reduced supplemental calcium requirements by 37% (P = 0.006) and 1,25-dihydroxyvitamin D requirements by 45% (P = 0.008). Seven subjects (26%) were able to stop 1,25-dihydroxyvitamin D completely. Serum calcium concentration remained stable, and urinary calcium and phosphorus excretion fell. Lumbar spine BMD increased by 5.5 ± 9% at 4 yr (P < 0.0001). Femoral neck and total hip BMD remained stable. At 4 yr, distal radius BMD was not different from baseline. Bone turnover markers increased significantly, reaching a 3-fold peak from baseline values at 6–12 months (P < 0.05 for all), subsequently declining to steady-state levels at 30 months. Hypercalcemia was uncommon (11 episodes in eight subjects over 4 yr; 1.9% of all values), with most episodes occurring within the first 6 months and resolving with adjustment of supplemental calcium and vitamin D. Conclusions: PTH(1–84) treatment of hypoparathyroidism for up to 4 yr maintains the serum calcium concentration, while significantly reducing supplemental calcium and 1,25-dihydroxyvitamin D requirements. Lumbar spine BMD increases without significant changes at other sites. These data provide support for the safety and efficacy of PTH(1–84) therapy in hypoparathyroidism for up to 4 yr. PMID:23162103

  4. Clinical performance of the Nevisense system in cutaneous melanoma detection: an international, multicentre, prospective and blinded clinical trial on efficacy and safety

    PubMed Central

    Malvehy, J; Hauschild, A; Curiel-Lewandrowski, C; Mohr, P; Hofmann-Wellenhof, R; Motley, R; Berking, C; Grossman, D; Paoli, J; Loquai, C; Olah, J; Reinhold, U; Wenger, H; Dirschka, T; Davis, S; Henderson, C; Rabinovitz, H; Welzel, J; Schadendorf, D; Birgersson, U

    2014-01-01

    Summary Background Even though progress has been made, the detection of melanoma still poses a challenge. In light of this situation, the Nevisense electrical impedance spectroscopy (EIS) system (SciBase AB, Stockholm, Sweden) was designed and shown to have the potential to be used as an adjunct diagnostic tool for melanoma detection. Objectives To assess the effectiveness and safety of the Nevisense system in the distinction of benign lesions of the skin from melanoma with electrical impedance spectroscopy. Methods This multicentre, prospective, and blinded clinical study was conducted at five American and 17 European investigational sites. All eligible skin lesions in the study were examined with the EIS-based Nevisense system, photographed, removed by excisional biopsy and subjected to histopathological evaluation. A postprocedure clinical follow-up was conducted at 7 ± 3 days from the initial measurement. A total of 1951 patients with 2416 lesions were enrolled into the study; 1943 lesions were eligible and evaluable for the primary efficacy end point, including 265 melanomas – 112 in situ and 153 invasive melanomas with a median Breslow thickness of 0·57 mm [48 basal cell carcinomas (BCCs) and seven squamous cell carcinomas (SCCs)]. Results The observed sensitivity of Nevisense was 96·6% (256 of 265 melanomas) with an exact one-sided 95% lower confidence bound estimated at 94·2% and an observed specificity of 34·4%, and an exact two-sided 95% confidence bound estimated at 32·0–36·9%. The positive and negative predictive values of Nevisense were 21·1% and 98·2%, respectively. The observed sensitivity for nonmelanoma skin cancer was 100% (55 of 48 BCCs and seven SCCs) with an exact two-sided 95% confidence bound estimated at 93·5–100·0%. Conclusions Nevisense is an accurate and safe device to support clinicians in the detection of cutaneous melanoma. What's already known about this topic? Although progress has been made in the detection of

  5. 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

  6. 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…

  7. 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

  8. Efficacy of electroconvulsive therapy combined with antipsychotic medication in treatment-resistant schizophrenia: a prospective, open trial.

    PubMed

    Tang, Wai Kwong; Ungvari, Gabor S

    2002-06-01

    This study examined the short-term efficacy of electroconvulsive therapy (ECT) combined with antipsychotic medication in treatment-resistant schizophrenia (TRS). Fifteen patients with TRS from an in-patient psychiatric rehabilitation unit participated. Patients completed a course of ECT consisting of 8 to 20 sessions, while their antipsychotic medications were continued throughout the study. Patients were assessed at baseline, 1 week, 1 month, and 2 months after their last ECT session. Assessment instruments included the Brief Psychiatric Rating Scale (BPRS), Hamilton Depression Rating Scale, Scale for the Assessment of Negative Symptoms (SANS), Global Assessment Scale (GAS), Clinical Global Impression (CGI), Nurses' Observation Scale for In-Patient Evaluation, and occupational therapists' rating of the patients' functioning with respect to work, social, and leisure activities. Compared with the baseline assessment, at each posttreatment evaluation, patients showed statistically significant improvement in the GAS and CGI. In addition, they were significantly better in terms of BPRS and SANS scores, as well as work performance and social functioning at the 2-month post-ECT evaluation. PMID:12195137

  9. Prospective evaluation of outcome measures in free-flap surgery.

    PubMed

    Kelly, John L; Eadie, Patricia A; Orr, David; Al-Rawi, Mogdad; O'Donnell, Margaret; Lawlor, Denis

    2004-08-01

    Free-flap failure is usually caused by venous or arterial thrombosis. In many cases, lack of experience and surgical delay also contribute to flap loss. The authors prospectively analyzed the outcome of 57 free flaps over a 28-month period (January, 1999 to April, 2001). The setting was a university hospital tertiary referral center. Anastomotic technique, ischemia time, choice of anticoagulant, and the grade of surgeon were recorded. The type of flap, medications, and co-morbidities, including preoperative radiotherapy, were also documented. Ten flaps were re-explored (17 percent). There were four cases of complete flap failure (6.7 percent) and five cases of partial failure (8.5 percent). In patients who received perioperative systemic heparin or dextran, there was no evidence of flap failure (p = .08). The mean ischemia time was similar in flaps that failed (95 +/- 29 min) and in those that survived (92 +/- 34 min). Also, the number of anastomoses performed by trainees in flaps that failed (22 percent), was similar to the number in flaps that survived (28 percent). Nine patients received preoperative radiotherapy, and there was complete flap survival in each case. This study reveals that closely supervised anastomoses performed by trainees may have a similar outcome to those performed by more senior surgeons. There was no adverse effect from radiotherapy or increased ischemia time on flap survival. PMID:15356760

  10. 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

  11. 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. PMID:24782203

  12. 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. PMID:26704926

  13. Prospective Evaluation of Hot Flashes during Pregnancy and Postpartum

    PubMed Central

    Thurston, Rebecca C.; Luther, James F.; Wisniewski, Stephen R.; Eng, Heather; Wisner, Katherine L.

    2014-01-01

    Objective To determine the prevalence, course, and risk factors for hot flashes during pregnancy and postpartum. Study Design Women (N=429) were assessed prospectively during pregnancy (weeks 20, 30, 36) and up to a year after delivery (weeks 2, 12, 26, 52). A clinical interview, physical measurements, and questionnaires were administered at each visit. Results Thirty-five percent of women reported hot flashes during pregnancy and 29% reported hot flashes after delivery. In multivariable binomial mixed effects models, women who were younger (per year: OR(95%CI): 0.94(0.88–0.99)), had a higher pre-pregnancy body mass index (BMI; per unit increase: OR(95%CI): 1.05(1.01–1.10)), and had less than a college education (OR(95%CI): 2.58(1.19–5.60); vs. college) were more likely to report hot flashes during pregnancy. Higher depressive symptoms were associated with hot flashes during pregnancy (per unit increase: OR(95%CI): 1.08(1.04–1.13)) and after birth (OR(95%CI): 1.19(1.14–1.25), multivariable models). Conclusion Hot flashes, typically considered a menopausal symptom, were reported by over a third of women during pregnancy and/or postpartum. Predictors of hot flashes during this reproductive transition, including depressive symptoms, low education, and higher BMI are similar to those experienced during menopause. Future work should investigate the role of hormonal and affective factors in hot flashes during pregnancy and postpartum. PMID:24035604

  14. Making hard choices easier: a prospective, multicentre study to assess the efficacy of a fertility-related decision aid in young women with early-stage breast cancer

    PubMed Central

    Peate, M; Meiser, B; Cheah, B C; Saunders, C; Butow, P; Thewes, B; Hart, R; Phillips, K-A; Hickey, M; Friedlander, M

    2012-01-01

    Background: Fertility is a priority for many young women with breast cancer. Women need to be informed about interventions to retain fertility before chemotherapy so as to make good quality decisions. This study aimed to prospectively evaluate the efficacy of a fertility-related decision aid (DA). Methods: A total of 120 newly diagnosed early-stage breast cancer patients from 19 Australian oncology clinics, aged 18–40 years and desired future fertility, were assessed on decisional conflict, knowledge, decision regret, and satisfaction about fertility-related treatment decisions. These were measured at baseline, 1 and 12 months, and were examined using linear mixed effects models. Results: Compared with usual care, women who received the DA had reduced decisional conflict (β=−1.51; 95%CI: −2.54 to 0.48; P=0.004) and improved knowledge (β=0.09; 95%CI: 0.01–0.16; P=0.02), after adjusting for education, desire for children and baseline uncertainty. The DA was associated with reduced decisional regret at 1 year (β=−3.73; 95%CI: −7.12 to −0.35; P=0.031), after adjusting for education. Women who received the DA were more satisfied with the information received on the impact of cancer treatment on fertility (P<0.001), fertility options (P=0.005), and rated it more helpful (P=0.002), than those who received standard care. Conclusion: These findings support widespread use of this DA shortly after diagnosis (before chemotherapy) among younger breast cancer patients who have not completed their families. PMID:22415294

  15. Is the intraosseous access route fast and efficacious compared to conventional central venous catheterization in adult patients under resuscitation in the emergency department? A prospective observational pilot study

    PubMed Central

    Leidel, Bernd A; Kirchhoff, Chlodwig; Bogner, Viktoria; Stegmaier, Julia; Mutschler, Wolf; Kanz, Karl-Georg; Braunstein, Volker

    2009-01-01

    Background For patients' safety reasons, current American Heart Association and European Resuscitation Council guidelines recommend intraosseous (IO) vascular access as an alternative in cases of emergency, if prompt venous catheterization is impossible. The purpose of this study was to compare the IO access as a bridging procedure versus central venous catheterization (CVC) for in-hospital adult emergency patients under resuscitation with impossible peripheral intravenous (IV) access. We hypothesised, that CVC is faster and more efficacious compared to IO access. Methods A prospective observational study comparing success rates and procedure times of IO access (EZ-IO, Vidacare Corporation) versus CVC in adult (≥18 years of age) patients under trauma and medical resuscitation admitted to our emergency department with impossible peripheral IV catheterization was conducted. Procedure time was defined from preparation and insertion of vascular access type until first drug or infusion solution administration. Success rate on first attempt and procedure time for each access route was evaluated and statistically tested. Results Ten consecutive adult patients under resuscitation, each receiving IO access and CVC, were analyzed. IO access was performed with 10 tibial or humeral insertions, CVC in 10 internal jugular or subclavian veins. The success rate on first attempt was 90% for IO insertion versus 60% for CVC. Mean procedure time was significantly lower for IO cannulation (2.3 min ± 0.8) compared to CVC (9.9 min ± 3.7) (p < 0.001). As for complications, failure of IO access was observed in one patient, while two or more attempts of CVC were necessary in four patients. No other relevant complications, like infection, bleeding or pneumothorax were observed. Conclusion Preliminary data demonstrate that IO access is a reliable bridging method to gain vascular access for in-hospital adult emergency patients under trauma or medical resuscitation with impossible

  16. 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

  17. Evaluation of anesthesia management, feasibility and efficacy of peroral endoscopic myotomy (POEM) for achalasia performed in the endoscopy unit

    PubMed Central

    Yang, Dennis; Pannu, Davinderbir; Zhang, Qing; White, Jeffrey D.; Draganov, Peter V.

    2015-01-01

    Introduction: Data on anesthesia management and outcomes associated with peroral endoscopic myotomy (POEM) performed exclusively in the endoscopy unit are limited. In this prospective study, we evaluated the safety of anesthesia management, and the feasibility and efficacy of POEM performed exclusively in the endoscopy unit. Methods: A single-center prospective study of consecutive patients with achalasia treated with POEM in an endoscopy unit was performed. Safety of anesthesia management and POEM were determined by procedure-related adverse events. Feasibility was assessed by completion rate. Short-term efficacy was established by clinical success (Eckardt score ≤ 3) and by comparing Eckardt and dysphagia scores before and after POEM. Results: Patients (n = 52) underwent POEM under general anesthesia with endotracheal intubation and positive pressure ventilation. Aspiration was prevented by keeping patients on a clear liquid diet before the procedure without requiring a prior esophagogastroduodenoscopy for esophageal content clearance. POEM completion rate was 96 % (50/52 patients). There was no post-POEM bleeding. Postprocedure leak was observed in one patient (3 %). Four patients (7.7 %) experienced mucosal injury, three of them were treated uneventfully endoscopically and one required laparoscopic repair. Clinical success was achieved in 88 % of patients. There was a significant decrease in the mean Eckardt score (8.1 to 1.4) and dysphagia score (2.4 to 0.4) (P < 0.0001) at the one month follow up after POEM. Conclusion: Anesthesia management of POEM is safe in the endoscopy unit and aspiration can be prevented without requiring prior esophagogastroduodenoscopy for esophageal content clearance. Overall, POEM performed by a gastroenterologist in the endoscopy unit was feasible and effective for the treatment of achalasia. PMID:26357672

  18. 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

  19. 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…

  20. 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…

  1. Prospective Evaluation of Operating Characteristics of Prostate Cancer Detection Biomarkers

    PubMed Central

    Liang, Yuanyuan; Ankerst, Donna P.; Ketchum, Norma S.; Ercole, Barbara; Shah, Girish; Shaughnessy, John D.; Leach, Robin J.; Thompson, Ian M.

    2016-01-01

    Purpose We assessed the independent predictive values of the serum markers free prostate specific antigen, proenzyme prostate specific antigen, neuroendocrine marker and Dickkopf-1 compared to serum prostate specific antigen and other standard risk factors for early prostate cancer detection. Materials and Methods From the prospectively collected SABOR cohort 250 prostate cancer cases, and 250 mean age matched and proportion of African-American race/ethnicity matched controls were selected who had a prior available prostate specific antigen and digital rectal examination. Serum samples were obtained, and free prostate specific antigen, [−2]proenzyme prostate specific antigen, Dickkopf-1 and neuroendocrine marker were measured. AUC, sensitivities and specificities were calculated, and multivariable logistic regression was used to assess the independent predictive value compared to prostate specific antigen, digital rectal examination, family history, prior biopsy history, race/ethnicity and age. Results The AUCs (95% CI) were 0.76 (0.71, 0.8) for free prostate specific antigen, 0.72 (0.67, 0.76) for [−2]proenzyme prostate specific antigen, 0.76 (0.72, 0.8) for %free prostate specific antigen, 0.61 (0.56, 0.66) for %[−2]proenzyme prostate specific antigen, 0.73 (0.68, 0.77) for prostate health index, 0.53 (0.48, 0.58) for Dickkopf-1 and 0.53 (0.48, 0.59) for neuroendocrine marker. In the 2 to 10 ng/ml prostate specific antigen range the AUCs (95% CI) were 0.58 (0.49, 0.67) for free prostate specific antigen, 0.53 (0.44, 0.62) for [−2]proenzyme prostate specific antigen, 0.67 (0.59, 0.75) for %free prostate specific antigen, 0.57 (0.49, 0.65) for %[−2]proenzyme prostate specific antigen and 0.59 (0.51, 0.67) for phi. Only %free prostate specific antigen retained independent predictive value compared to the traditional risk factors. Conclusions Free prostate specific antigen retained independent diagnostic usefulness for prostate cancers detected through

  2. Conceptual Paradigms and Empirical Investigations for Evaluating INTELSAT's Past Performance and Future Prospects.

    ERIC Educational Resources Information Center

    Snow, Marcellus S.

    This paper summarizes the results of a recent study of the past performance and future prospects of the International Telecommunications Satellite (INTELSAT) Organization. First, an overview of INTELSAT's history is provided and major policy issues are detailed. Five alternative paradigms are then presented through which to evaluate INTELSAT's…

  3. 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…

  4. 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…

  5. AGRONOMIC EVALUATION OF SMOOTH ROOT RELEASES AND PROSPECTIVE RELEASES - 2001

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Performance evaluations for standard agronomic parameters as well as root suture prominence score were conducted on 10 experimental and two standard commercial hybrids. Recoverable White Sugar per Acre (RWSA) was the most useful yield measurement. It was apparent that gains have been made in increas...

  6. 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.

  7. 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

  8. 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. PMID:25549218

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

    PubMed Central

    Kim, Su-Yeon

    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. PMID:25549218

  10. 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. PMID:11423189

  11. 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

  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. What Predicts the Trajectory of Rumination?: A Prospective Evaluation

    PubMed Central

    Grant, DeMond M.; Beck, J. Gayle

    2010-01-01

    The current report aimed to document individual differences that predict the trajectory of post-event rumination following an evaluative event. In this study, 127 undergraduate students were assessed over a 5-day period preceding and following a midterm exam. Participants completed measures of anticipatory processing, trait test anxiety, trait tendency to ruminate, negative affect, and post-event rumination. Hierarchical linear modeling was used to examine predictors of post-evaluative rumination. Results suggested that individuals who reported high levels of anticipatory processing and trait test anxiety tended to experience prolonged amounts of rumination following the exam, even when controlling for negative affect, relative to those who scored low on these measures. These results suggest that specific individual difference factors impact the amount and trajectory of rumination beyond levels of general negative affect. Implications for understanding risk factors for heightened rumination are discussed, with particular attention to the larger rumination literature. PMID:20381304

  14. 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. PMID:25765624

  15. 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. PMID:8354723

  16. 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. PMID:27126336

  17. Efficacy and safety of flexibly dosed paliperidone palmitate in Chinese patients with acute schizophrenia: an open-label, single-arm, prospective, interventional study

    PubMed Central

    Si, Tianmei; Zhang, Kerang; Tang, Jisheng; Fang, Maosheng; Li, Keqing; Zhuo, Jianmin; Feng, Yu

    2015-01-01

    This open-label, single-arm, multicenter, 13-week, prospective study explored the efficacy, safety, and tolerability of paliperidone palmitate (150 milligram equivalents [mg eq] [day 1], 100 mg eq [day 8], both deltoid injections; 75–150 mg eq, deltoid/gluteal injection) in Chinese patients with acute schizophrenia (Positive and Negative Syndrome Scale [PANSS] total score ≥70), who previously had unsatisfactory therapeutic effect following oral antipsychotic treatment (without washout period). Primary efficacy endpoint was percentage of patients with ≥30% improvement in the PANSS total score at the end of 13 weeks. Secondary efficacy endpoints included change from baseline to end of week 13 in PANSS total score, PANSS subscale scores, Marder factor scores, Clinical Global Impressions–Severity score, and Personal and Social Performance Scale scores. Overall, 477/610 enrolled patients (full analysis set, 78.2%) completed the study (men: 55.1%; women: 44.9%; mean age: 31.5 years). Total, 443/610 (72.6%, full analysis set) patients achieved primary endpoint (mean [standard deviation] change from baseline: –30.9 [19.51]). All secondary endpoints demonstrated significant improvement at the end of 13 weeks. One death occurred during this acute phase. The most common (>5%) treatment-emergent adverse events were extrapyramidal disorders (8.4%). The efficacy and safety data are consistent with other short-term, placebo-controlled studies of paliperidone palmitate conducted in similar populations. PMID:26150719

  18. 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.

  19. Function Self-Efficacy Scale-FSES: Development, Evaluation, and Contribution to Well-Being.

    PubMed

    Tovel, Hava; Carmel, Sara

    2016-08-01

    This article describes the development and validation of the Function Self-Efficacy Scale (FSES) for assessing the degree of confidence in self-functioning while facing decline in health and function (DHF). The FSES was evaluated in two studies of older Israelis, aged 75+ years. Data were collected by structured home interviews. Exploratory factor analyses conducted in both studies clearly revealed two underlying factors: emotion self-efficacy and action self-efficacy. Confirmatory factor analyses resulted in acceptable model fit criteria. The shortened final 13-item FSES had good internal consistency and satisfactory criterion and convergent validity. Multiple regression analyses, conducted to predict subjective well-being in each of the studies, showed that function self-efficacy had a positive and significant contribution to the explanation of well-being, while controlling for general self-efficacy, self-rated health, and sociodemographic variables. We propose that appropriate interventions can strengthen function self-efficacy, thus improving the well-being of elderly persons and their ability to cope with DHF. PMID:26239228

  20. 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.

  1. 21 CFR 201.200 - Disclosure of drug efficacy study evaluations in labeling and advertising.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Disclosure of drug efficacy study evaluations in labeling and advertising. 201.200 Section 201.200 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... Commissioner of Food and Drugs from the National Academy of Sciences (1969).” As the report notes, this...

  2. 21 CFR 201.200 - Disclosure of drug efficacy study evaluations in labeling and advertising.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Disclosure of drug efficacy study evaluations in labeling and advertising. 201.200 Section 201.200 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... Commissioner of Food and Drugs from the National Academy of Sciences (1969).” As the report notes, this...

  3. 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...

  4. 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…

  5. 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,...

  6. 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).…

  7. 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...

  8. 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...

  9. 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…

  10. 21 CFR 201.200 - Disclosure of drug efficacy study evaluations in labeling and advertising.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Disclosure of drug efficacy study evaluations in labeling and advertising. 201.200 Section 201.200 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... Commissioner of Food and Drugs from the National Academy of Sciences (1969).” As the report notes, this...

  11. 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…

  12. 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…

  13. An Interactive Web-Based Program for Stepfamilies: Development and Evaluation of Efficacy

    ERIC Educational Resources Information Center

    Gelatt, Vicky A.; Adler-Baeder, Francesca; Seeley, John R.

    2010-01-01

    This study evaluated the efficacy of a family life education program for stepfamilies that is self-administered, interactive, and web-based. The program uses behavior-modeling videos to demonstrate effective couple, parenting, and stepparenting practices. A diverse sample of 300 parents/stepparents of a child aged 11-15 years were randomized into…

  14. 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...

  15. Prospective evaluation of the cause of acute pancreatitis, with special attention to medicines

    PubMed Central

    Rashidi, Mitra; Røkke, Ola

    2016-01-01

    AIM: To investigate the cause of acute pancreatitis (AP) by conducting a thorough investigation of drugs and their possible etiological role. METHODS: We investigated the cause of AP in a large retrospective cohort of 613 adult patients admitted with AP at the Akershus University Hospital, Norway, from 2000 until 2009, who were evaluated with standard ward investigations. This group was compared with a prospectively evaluated group (n = 57) admitted from January 2010 until September 2010 who investigated more extensively using medical history and radiological assessment. RESULTS: The groups were comparable with regards to gender, age, comorbidity and severity. The most common etiology was bile stones and alcohol, occurring in 60% in both groups. The prospective group was examined more thoroughly with regards to the use of alcohol and medicines. An increased number of radiological investigations during hospital stay and at follow-up were also performed. A more extensive use of radiological evaluation did not increase the detection frequency of bile stones. In the prospective group, more than half of the patients had two or more possible causes of pancreatitis, being mostly a combination of bile stones and drugs. No possible cause was found in only 3.5% of these patients, compared with 29.7% in the retrospective group. CONCLUSION: A detailed medical history and extensive radiological evaluation may determine a possible etiology in almost all cases of AP. Many patients have several possible risk factors, and uncertainty remains in establishing the definitive etiology. PMID:26877614

  16. Clinical and serological efficacy of topical calcineurin inhibitors in oral lichen planus: a prospective randomized controlled trial.

    PubMed

    Vohra, Suruchi; Singal, Archana; Sharma, Suman Bala

    2016-01-01

    Oral lichen planus (OLP) is a T-cell-mediated disease characterized by immune-mediated basal cell degeneration releasing interleukins (ILs) such as IL-6 and IL-8 into the circulation. Their serum levels reportedly reflect disease activity. Although many therapeutic options are available, none are curative. We compared the efficacy of tacrolimus 0.1% ointment and pimecrolimus 1% cream in OLP and correlated with serum IL-6 and IL-8 levels before and after treatment. Forty patients with symptomatic OLP were randomized into two groups, to receive either topical tacrolimus 0.1% ointment or pimecrolimus 1% cream (twice daily for 8 weeks). Patients were assessed at 2, 4, 8, and 12 weeks. At each visit, objective improvement in the net clinical score (NCS), drug tolerability, and side effects were evaluated. Serum IL-6 and IL-8 levels were measured at baseline and at eight weeks. Baseline characteristics were comparable between the groups. The mean NCS declined from 10.9 ± 4.5 and 9.9 ± 4.6 at baseline to 5.4 ± 3.5 and 5.3 ± 4.2 at 12 weeks for tacrolimus and pimecrolimus group, respectively. At each visit, in both groups, the decline in mean NCS from baseline was statistically significant (P < 0.05) and so was the decline in mean serum IL-6 and IL-8 levels pre- and post-treatment. Pimecrolimus 1% cream seems to be as effective as tacrolimus 0.1% ointment. Serum IL-6 and IL-8 may act as markers of disease activity. However, future efforts are needed to objectify the use of serum interleukin levels in the disease severity index. PMID:26147635

  17. A Multicenter, Prospective Study of a Novel Nasal EPAP Device in the Treatment of Obstructive Sleep Apnea: Efficacy and 30-Day Adherence

    PubMed Central

    Rosenthal, Leon; Massie, Clifford A.; Dolan, Diana C.; Loomas, Bryan; Kram, Jerrold; Hart, Robert W.

    2009-01-01

    Study Objectives: Evaluate the efficacy of a novel device placed in the nares that imposes an expiratory resistance for the treatment of obstructive sleep apnea (OSA) and evaluate adherence to the device over a 30-day in-home trial period. Design: One diagnostic and 3 treatment polysomnograms were administered in a Latin-square design to identify the optimal expiratory resistance to be used during the 30-day in-home trial. Subjects had repeat polysomnography with the prescribed device at the end of the 30-day trial. Setting: Multicenter study. Participants: Participants (N = 34; age 27 to 67) with a baseline apnea-hypopnea index (AHI) ≥ 5. Measurements and Results: The AHI was reduced from 24.5 ± 23.6 (mean ± SD) to an average of 13.5 ± 18.7 (p < 0.001) across initial treatment nights. The AHI was 15.5 ± 18.9 (p = 0.001) for the prescribed device at the end of the 30-day trial. Of 24 subjects with an AHI > 10 at baseline, 13 achieved an AHI ≤ 10 on the initial treatment nights; 10 had a similar response on the final treatment night. Percent of the night snoring decreased from 27.5 ± 23.2 to 11.6 ± 13.7 (p < 0.001) on initial treatment nights and 14.6 ± 20.6 (p = 0.013) at the end of the trial; Epworth Sleepiness scores decreased from 8.7 ± 4.0 at baseline to 6.9 ± 4.4 (p < 0.001) at the end of the trial; the Pittsburgh Sleep Quality Index improved from 7.4 ± 3.3 to 6.5 ± 3.6 (p = 0.042). Mean oxygen saturation increased from 94.8 ± 2.0 to 95.2 ± 1.9 (p = 0.023) on initial treatment nights and 95.3 ± 1.9 (p = 0.003) at the end of the trial. Sleep architecture was not affected. Participants reported using the device all night long for 94% of nights during the in-home trial. Conclusions: Treatment with this novel device was well tolerated and accepted by the participants. An overall reduction in AHI was documented; however, therapeutic response was variable among the participants. Further research is required to identify the ideal candidates for this

  18. Cholecystitis: prospective evaluation of sonography and /sup 99m/ Tc-HIDA cholescintigraphy

    SciTech Connect

    Worthen, N.J.; Uszler, J.M.; Funamura, J.L.

    1981-11-01

    Major and minor criteria are determined for sonographic diagnosis of acute and chronic cholecystitis. A prospective study of 113 cases was performed on patients with suspected acute cholecystitis who were evaluated by cholesonography and /sup 99m/Tc-HIDA cholescintigraphy. Data support the use of sonography as the intial imaging procedure for the patient with suspected acute cholecystitis. /sup 99m/Tc-HIDA is useful in those cases without stones which exhibit minor criteria for gallbladder abnormality.

  19. 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

  20. 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. PMID:26364480

  1. Evaluation of a Geothermal Prospect Using a Stochastic Joint Inversion Algorithm

    NASA Astrophysics Data System (ADS)

    Tompson, A. F.; Mellors, R. J.; Ramirez, A.; Dyer, K.; Yang, X.; Trainor-Guitton, W.; Wagoner, J. L.

    2013-12-01

    A stochastic joint inverse algorithm to analyze diverse geophysical and hydrologic data for a geothermal prospect is developed. The purpose is to improve prospect evaluation by finding an ensemble of hydrothermal flow models that are most consistent with multiple types of data sets. The staged approach combines Bayesian inference within a Markov Chain Monte Carlo (MCMC) global search algorithm. The method is highly flexible and capable of accommodating multiple and diverse datasets as a means to maximize the utility of all available data to understand system behavior. An initial application is made at a geothermal prospect located near Superstition Mountain in the western Salton Trough in California. Readily available data include three thermal gradient exploration boreholes, borehole resistivity logs, magnetotelluric and gravity geophysical surveys, surface heat flux measurements, and other nearby hydrologic and geologic information. Initial estimates of uncertainty in structural or parametric characteristics of the prospect are used to drive large numbers of simulations of hydrothermal fluid flow and related geophysical processes using random realizations of the conceptual geothermal system. Uncertainty in the results is represented within a ranked subset of model realizations that best match all available data within a specified norm or tolerance. Statistical (posterior) characteristics of these solutions reflect reductions in the perceived (prior) uncertainties. This work was performed under the auspices of the U.S. Department of Energy by Lawrence Livermore National Laboratory under Contract DE-AC52-07NA27344. LLNL-ABS-641792.

  2. 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.

  3. Efficacy of thrombomodulin for acute exacerbation of idiopathic pulmonary fibrosis and nonspecific interstitial pneumonia: a nonrandomized prospective study

    PubMed Central

    Abe, Mitsuhiro; Tsushima, Kenji; Matsumura, Takuma; Ishiwata, Tsukasa; Ichimura, Yasunori; Ikari, Jun; Terada, Jiro; Tada, Yuji; Sakao, Seiichirou; Tanabe, Nobuhiro; Tatsumi, Koichiro

    2015-01-01

    Purpose Acute exacerbation (AE) is an important outcome of idiopathic pulmonary fibrosis (IPF) and nonspecific interstitial pneumonia (NSIP). Recombinant human soluble thrombomodulin (rhTM) is a new drug for the treatment of disseminated intravascular coagulation in Japan. The objective of this study was to evaluate the efficacy of rhTM for AE of IPF/NSIP. Methods Twenty-two patients with AE-idiopathic interstitial pneumonia (16 patients with IPF and six patients with NSIP) were enrolled in our study. Among them, eleven patients were treated with rhTM (rhTM group), and eleven patients were treated without rhTM (non-rhTM group). Patients admitted to our hospital prior to December 2013 were treated with rhTM, while those admitted after January 2014 were treated without rhTM. The primary endpoint was mortality at 90 days after AE treatment. The secondary endpoint was the safety of rhTM for AE-IPF/AE-NSIP. In addition, we examined prognostic factors of AE-IPF/AE-NSIP. Results The mortality rate was significantly lower in the rhTM group than in the non-rhTM group (mortality rate at 90 days: 36% vs 90%, P=0.023; median survival time: not reached vs 15.0 days, P=0.019). A univariate analysis revealed the respiratory rate (hazard ratio [HR] 1.09, 95% confidence interval [CI] 1.00–1.18, P=0.039) and rhTM administration (HR 0.21, 95% CI 0.06–0.77, P=0.013) as predictors of mortality at 90 days, and a multivariate analysis identified rhTM administration (HR 0.025, 95% CI 0.0006–0.94, P=0.046) as an independent predictor of mortality at 90 days. No serious adverse events were observed. Conclusion The administration of rhTM is associated with reductions in mortality in patients with AE-IPF/NSIP, without causing adverse events. PMID:26566367

  4. 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

  5. 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

  6. Evaluation of the sterilization efficacy of domestic electric drills used in orthopaedic surgeries

    PubMed Central

    Goveia, Vania Regina; Pinto, Flavia Morais Gomes; Machoshvili, Irene Alexeevna; Penna, Thereza Christina Vessoni; Graziano, Kazuko Uchikawa

    2009-01-01

    It is estimated that electric drills (ED) have been used in orthopaedic surgeries for bone drilling for more than 50 years in Brazilian hospitals. It is an electric, thermosensitive equipment, not indicated for surgical use, which has not been previously evaluated regarding the sterilization efficacy, being suspect of infection risk. This study evaluated the efficacy of sterilization by ethylene oxide (EtO) of new drills that were intentionally contaminated with Bacillus atrophaeus spores. An experimental, laboratory, randomized applied research was developed, where 16 electric drills were analyzed, in addition to positive and negative controls. All the previously cleaned and sterilized equipment were submitted to contamination by spores. The experimental group was submitted to cleaning and sterilization by EtO and test of sterility by filtration through a 0.45 >m membrane. The membranes were cultivated and Gram and Wirtz-Conklin staining were carried out in positive results for spore visualization. An efficacy of 99.99999881% of the process of sterilization by EtO was confirmed, with a probability of survival of 1.19 x 10 -8. Under the development conditions of the experiment, the efficacy of the sterilization of ED by EtO was confirmed. PMID:24031397

  7. Development and evaluation of the Marijuana Reduction Strategies Self-Efficacy Scale.

    PubMed

    Davis, Alan K; Osborn, Lawrence A; Leith, Jaclyn; Rosenberg, Harold; Ashrafioun, Lisham; Hawley, Anna; Bannon, Erin E; Jesse, Samantha; Kraus, Shane; Kryszak, Elizabeth; Cross, Nicole; Carhart, Victoria; Baik, Kyoung-deok

    2014-06-01

    To evaluate several psychometric properties of a questionnaire designed to assess college students' self-efficacy to employ 21 cognitive-behavioral strategies intended to reduce the amount and/or frequency with which they consume marijuana, we recruited 273 marijuana-using students to rate their confidence that they could employ each of the strategies. Examination of frequency counts for each item, principal components analysis, internal consistency reliability, and mean interitem correlation supported retaining all 21 items in a single scale. In support of criterion validity, marijuana use-reduction self-efficacy scores were significantly positively correlated with cross-situational confidence to abstain from marijuana, and significantly negatively correlated with quantity and frequency of marijuana use and marijuana-related problems. In addition, compared with respondents whose use of marijuana either increased or remained stable, self-efficacy was significantly higher among those who had decreased their use of marijuana over the past year. This relatively short and easily administered questionnaire could be used to identify college students who have low self-efficacy to employ specific marijuana reduction strategies and as an outcome measure to evaluate educational and skill-training interventions. PMID:24955675

  8. Anti-pruritic Effect of Sertaconazole 2% Cream in Atopic Dermatitis Subjects: A Prospective, Randomized, Double-blind, Vehicle-controlled, Multi-centre Clinical Trial of Efficacy, Safety and Local Tolerability.

    PubMed

    Ständer, Sonja; Metz, Martin; Ramos F, Mac H; Maurer, Marcus; Schoepke, Nicole; Tsianakas, Athanasios; Zeidler, Claudia; Luger, Thomas A

    2016-08-23

    This study was a prospective, parallel-group, randomized, double-blind, vehicle-controlled, multi-centre clinical trial to compare the efficacy of topical sertaconazole 2% cream with vehicle in reducing chronic pruritus in subjects with atopic dermatitis, and to assess its safety and local tolerability. A total of 70 subjects applied either of the 2 treatments twice daily for a period of 4 weeks on affected, itchy skin areas. Treatment efficacy was evaluated primarily considering the item itch intensity on a 5-point verbal rating scale. Insomnia, state of atopic dermatitis (Scoring Atopic Dermatitis; SCORAD), quality of life and therapy benefit were also assessed. No significant difference between active treatment and vehicle was found at any of the time-points for any of the investigated parameters. Under the experimental conditions of the study, sertaconazole 2% cream did not exert anti-pruritic effects that were better than vehicle in subjects with atopic dermatitis who had chronic pruritus. Trial registration ClinicalTrials.gov #NCT01792713. PMID:26527564

  9. 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.

  10. In vitro evaluation of the disinfection efficacy on Eimeria tenella unsporulated oocysts isolated from broilers.

    PubMed

    Guimarães, José S; Bogado, Alexey L Gomel; da Cunha, Thiago Cezar B; Garcia, João Luis

    2007-01-01

    The objective of this study was to evaluate in vitro the action of eight chemical principles by disinfection efficacy (DE) of Eimeria tenella oocysts. Disinfection efficacy was evaluated by either destruction or sporulation inhibition of the oocysts. Eight treatments were performed: T1 (Glutaraldehyde 42.5 g + Benzalkonium Chloride 7.5 g); T2 (Benzalkonium chloride + quaternary ammonium salt); T3 (formol 37% + Sodium Dodecylbenzene Sulfonate 12%); T4 (sodium hypochlorite 2%); T5 (Orthodichlorobenzene 60% + Xylene 30%); T6 (Polyoctyl polyamino ethyl glycine + Polyoxyethylene alkylphenol ether + Sodium Chloride); T7 (Chloramine T) and finally T8 (free iodine 2.25% + Phosphoric acid 15 g). The control test was carried out with distilled water (T9). The best DE were observed, respectively, in T3 (79.49%), T5 (75.60%) and T4 (65.56%) treatments. PMID:17706006

  11. The Impact of Type 2 Diabetes on the Efficacy of ADP Receptor Blockers in Patients with Acute ST Elevation Myocardial Infarction: A Pilot Prospective Study

    PubMed Central

    Fedor, Marián; Kovář, František; Galajda, Peter; Bolek, Tomáš; Stančiaková, Lucia; Fedorová, Jana; Staško, Ján; Kubisz, Peter; Mokáň, Marián

    2016-01-01

    Background. The aim of this study was to validate the impact of type 2 diabetes (T2D) on the platelet reactivity in patients with acute ST elevation myocardial infarction (STEMI) treated with adenosine diphosphate (ADP) receptor blockers. Methods. A pilot prospective study was performed. Totally 67 patients were enrolled. 21 patients had T2D. Among all study population, 33 patients received clopidogrel and 34 patients received prasugrel. The efficacy of ADP receptor blocker therapy had been tested in two time intervals using light transmission aggregometry with specific inducer and vasodilator-stimulated phosphoprotein phosphorylation (VASP-P) flow cytometry assay. Results. There were no significant differences in platelet aggregability among T2D and nondiabetic (ND) group. The platelet reactivity index of VASP-P did not differ significantly between T2D and ND group (59.4 ± 30.9% versus 60.0 ± 25.2% and 33.9 ± 25.3% versus 38.6 ± 29.3% in second testing). The number of ADP receptor blocker nonresponders did not differ significantly between T2D and ND patients. The time interval from ADP receptor blocker loading dosing to the blood sampling was similar in T2D and ND patients in both examinations. Conclusion. This prospective study did not confirm the higher platelet reactivity and higher prevalence of ADP receptor blocker nonresponders in T2D acute STEMI patients. PMID:27493970

  12. Efficacy of high frequency ultrasound in postoperative evaluation of carpal tunnel syndrome treatment

    PubMed Central

    Urbanik, Andrzej

    2016-01-01

    Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy and a frequent cause of sick leave because of work-related hand overload. The main treatment is operation. Aim The aim of the study is to assess the usefulness of high frequency ultrasound in the postoperative evaluation of CTS treatment efficacy. Material and methods Sixty-two patients (50 women and 12 men aged 28–70, mean age 55.2) underwent surgical treatment of CTS. Ultrasound examinations of the wrist in all carpal tunnel sufferers were performed 3 months after the procedure with the use of a high frequency broadband linear array transducer (6–18 MHz, using 18 MHz band) of MyLab 70/Esaote. On the basis of the collected data, the author has performed multiple analyses to confirm the usefulness of ultrasound imaging for postoperative evaluation of CTS treatment efficacy. Results Among all 62 patients, 3 months after surgical median nerve decompression: in 40 patients, CTS symptoms subsided completely, and sonographic evaluation did not show median nerve entrapment signs; in 9 patients, CTS symptoms persisted or exacerbated, and ultrasound proved nerve compression revealing preserved flexor retinaculum fibers; in 13 patients, scar tissue symptoms occurred, and in 5 of them CTS did not subside completely (although ultrasound showed no signs of compression). Conclusions Ultrasound imaging with the use of a high frequency transducer is a valuable diagnostic tool for postoperative assessment of CTS treatment efficacy. PMID:27103999

  13. [Efficacy of naftopidil in patients with overactive bladder associated with benign prostatic hyperplasia: prospective randomized controlled study to compare differences in efficacy between morning and evening medication].

    PubMed

    Sakai, Hideki; Igawa, Tsukasa; Onita, Toru; Furukawa, Masataka; Hakariya, Tomoaki; Hayashi, Mikio; Matsuya, Fukuzo; Shida, Yohei; Nishimura, Naoki; Yogi, Yasuo; Tsurusaki, Toshifumi; Takehara, Kousuke; Nomata, Koichiro; Shiraishi, Kazutaka; Shono, Takefumi; Aoki, Daiyu; Kanetake, Hiroshi

    2011-01-01

    A total of 100 patients with benign prostatic hyperplasia (BPH) and overactive bladder (OAB) symptoms (BPH/OAB), enrolled between June 2006 to March 2008, were randomly divided into 2 groups of morning medication (M) and evening medication (E) groups, then 50 mg of naftopidil was given once a day after breakfast or supper for 8 weeks. Data were available for efficacy analysis on 80 patients (M group ; 43, E group ; 37). Naftopidil significantly improved the overall international prostatic symptom score ; from 19.2±7.9 to 11.7±5.8 in the M group and from 19.4±6.4 to 12.3±6.8 in the E group (p<0.0001), QOL score from 4.9±0.8 to 3.2±1.4 in the M group and from 5.0±0.8 to 3.6±1.3 in the E group (p<0.0001), and OAB symptom score from 7.8±2.6 to 5.0±2.5 in the M group (p<0.0001) and from 8.6±2.9 to 5.8± 3.3 in the E group (p<0.0001). There was no significant difference in the incidence of adverse effects between the M group (6.1%) and E group (2.2%). These results suggest that naftopidil improves storage symptoms as well as voiding symptoms regardless of timing of administration. PMID:21304253

  14. Efficacy and safety of hydrostatic balloon dilation of ileocolonic Crohn's strictures. A prospective long-term analysis.

    PubMed

    Gevers, A M; Couckuyt, H; Coremans, G; Hiele, M; Rutgeerts, P

    1994-01-01

    Gastro-intestinal stricture frequently is a complication in Crohn's disease and often recurs after surgical resection. Stenosis with acute inflammation can be treated by anti-inflammatory medication. A conservative approach of sclerotic strictures has been possible since the introduction of Gruentzig balloon catheters for dilating stenosis in different parts of the gastro-intestinal tract. We present a prospective follow-up study in 55 patients, on the long-term results and safety of hydrostatic balloon dilations of ileo-colonic Crohn's strictures. PMID:7709702

  15. A randomized double-blind prospective study of the efficacy of pulsed electromagnetic fields for interbody lumbar fusions

    SciTech Connect

    Mooney, V. )

    1990-07-01

    A randomized double-blind prospective study of pulsed electromagnetic fields for lumbar interbody fusions was performed on 195 subjects. There were 98 subjects in the active group and 97 subjects in the placebo group. A brace containing equipment to induce an electromagnetic field was applied to patients undergoing interbody fusion in the active group, and a sham brace was used in the control group. In the active group there was a 92% success rate, while the control group had a 65% success rate (P greater than 0.005). The effectiveness of bone graft stimulation with the device is thus established.

  16. Improved BVDV1b challenge model for evaluating efficacy of protection against clinical signs following acute infection

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Introduction: Efficacy of bovine viral diarrhea virus (BVDV) vaccines in preventing acute infections is evaluated based on reduction of clinical disease. While high virulence BVDV2 strains are used in U.S. vaccine efficacy studies, the BVDV1 strain, NY-1, made available by the USDA as a challenge ...

  17. Applying fluorescence lifetime imaging microscopy to evaluate the efficacy of anticancer drugs

    NASA Astrophysics Data System (ADS)

    Kawanabe, Satoshi; Araki, Yoshie; Uchimura, Tomohiro; Imasaka, Totaro

    2015-06-01

    Fluorescence lifetime imaging microscopy was applied to evaluate the efficacy of anticancer drugs. A decrease in the fluorescence lifetime of the nucleus in apoptotic cancer cells stained by SYTO 13 dye was detected after treatment with antitumor antibiotics such as doxorubicin or epirubicin. It was confirmed that the change in fluorescence lifetime occurred earlier than morphological changes in the cells. We found that the fluorescence lifetime of the nucleus in the cells treated with epirubicin decreased more rapidly than that of the cells treated with doxorubicin. This implies that epirubicin was more efficacious than doxorubicin in the treatment of cancer cells. The change in fluorescence lifetime was, however, not indicated when the cells were treated with cyclophosphamide. The decrease in fluorescence lifetime was associated with the processes involving caspase activation and chromatin condensation. Therefore, this technique would provide useful information about apoptotic cells, particularly in the early stages.

  18. Efficacy of evaluation of rooster sperm morphology using different staining methods.

    PubMed

    Lukaszewicz, E; Jerysz, A; Partyka, A; Siudzińska, A

    2008-12-01

    This work focused on inexpensive methods of evaluation fowl sperm morphology, based on eosin-nigrosin smears, which can determine disorders in spermatogenesis and can be recommended for evaluating the fertilising potency and selecting males in flocks reproduced by artificial insemination. Four fowl breeds (Black Minorca, Italian Partridge, Forwerk and Greenleg Partridge) were used to determine the efficacy of sperm morphology evaluation using four eosin-nigrosin staining methods (according to Blom, Bakst and Cecil, Morisson, Jaśkowski) and three examiners of different experience (high, medium, novice). There were significant (P< or = 0.01) differences in sperm morphology between Blom's staining method and those of Bakst and Cecil, Morisson or Jaśkowski, irrespective of fowl breed and examiners experience. Blom stain caused sperm head swelling and showed a drastic reduction in the proportion of live spermatozoa with normal morphology. The staining method had a greater influence on sperm morphology evaluation than the experience of the examiners. PMID:18486956

  19. [Continuous nebulization with terbutaline sulfate under tent inhalation. Evaluation of the efficacy in children 2 to 5 years of age in asthmatic crises].

    PubMed

    Lotufo, J P; Ejzenberg, B; Vieira, S; Mukai, L; Macedo, H; Yamashita, C; Ventura, G; Baldacci, E R; Okay, Y

    1998-06-01

    This study investigated the efficacy of a system for continuous nebulization of terbutaline sulphate in the treatment of acute asthmatic crises in children. The equipment consisted of a condensation nebulizer attached to a 40 liter acrylic tent placed around the patient's head. A prospective, randomized and open clinical trial was conducted. Twenty eight children, 2 to 5 year-old, in acute asthmatic crises were selected. Fourteen were nebulized with terbutaline sulphate while in the control group the aerosolization was proceeded only with half diluted physiologic serum. All patients were administered aminophyline intravenously. The parameter used to evaluate the efficacy of the terbutaline sulphate nebulizing system was clinical improvement measured by the Wood-Downes Score. Two additional parameters indicating terbutaline sulphate absorption were used: reduction of potassium seric levels and positive chronotropic effect. The group treated with terbutaline sulphate showed greater clinical improvement than control group at the 12 hour protocol evaluation as well as lower seric potassium level. A positive chronotropic effect was also observed at the final protocol evaluation. The data showed, preliminarily, that (a) the system for continuous nebulization of terbutaline sulphate was effective in treatment of children's acute asthmatic crises, and (b) there was evidence attesting to the absorption of terbutaline sulphate by the children treatment with it. PMID:9677633

  20. 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

  1. Quantitative Methods for Evaluating the Efficacy of Thalamic Deep Brain Stimulation in Patients with Essential Tremor

    PubMed Central

    Wastensson, Gunilla; Holmberg, Björn; Johnels, Bo; Barregard, Lars

    2013-01-01

    Background Deep brain stimulation (DBS) of the thalamus is a safe and efficient method for treatment of disabling tremor in patient with essential tremor (ET). However, successful tremor suppression after surgery requires careful selection of stimulus parameters. Our aim was to examine the possible use of certain quantitative methods for evaluating the efficacy of thalamic DBS in ET patients in clinical practice, and to compare these methods with traditional clinical tests. Methods We examined 22 patients using the Essential Tremor Rating Scale (ETRS) and quantitative assessment of tremor with the stimulator both activated and deactivated. We used an accelerometer (CATSYS tremor Pen) for quantitative measurement of postural tremor, and a eurythmokinesimeter (EKM) to evaluate kinetic tremor in a rapid pointing task. Results The efficacy of DBS on tremor suppression was prominent irrespective of the method used. The agreement between clinical rating of postural tremor and tremor intensity as measured by the CATSYS tremor pen was relatively high (rs = 0.74). The agreement between kinetic tremor as assessed by the ETRS and the main outcome variable from the EKM test was low (rs = 0.34). The lack of agreement indicates that the EKM test is not comparable with the clinical test. Discussion Quantitative methods, such as the CATSYS tremor pen, could be a useful complement to clinical tremor assessment in evaluating the efficacy of DBS in clinical practice. Future studies should evaluate the precision of these methods and long-term impact on tremor suppression, activities of daily living (ADL) function and quality of life. PMID:24255800

  2. Prospective evaluation of /sup 99m/Tc-IDA cholescintigraphy and gray-scale ultrasound in the diagnosis of acute cholecystitis

    SciTech Connect

    Ralls, P.W.; Colletti, P.M.; Halls, J.M.; Siemsen, J.K.

    1982-07-01

    Prospective analysis of the efficacy of /sup 99m/Tc-IDA cholescintigraphy and cholecystosonography showed that both are excellent techniques for assessing patients with suspected acute cholecystitis (accuracy 84.7% and 88.1% respectively). Consequently, the choice of tests selected to evaluate patients with suspected acute cholecystitis depends on several factors including; (a.) quality of equipment available; (b.) capability of the technologist performing the examination; (c.) relative experience of the physician supervising the examination; and (d.) willingness of the surgical consultant to accept a positive examination as sufficient evidence to perform emergency surgery. The authors feel that cholecystosonography should be used to assess the presence of acute cholecystitis in jaundiced patients because of its capability in the assessment of bile duct dilatation, and because of the lower reliability of cholescintigraphy when bile duct obstruction is possible (i.e., in jaundice). Ancillary findings in cholecystosonography and cholescintigraphy can aid in the differential diagnosis of acute right upper quandrant pain syndromes.

  3. 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. PMID:26130833

  4. Prospective evaluation of skin surface electropotentials in Japanese patients with suspicious breast lesions.

    PubMed

    Fukuda, M; Shimizu, K; Okamoto, N; Arimura, T; Ohta, T; Yamaguchi, S; Faupel, M L

    1996-10-01

    The biofield breast examination (BBE) is a new, noninvasive and cost-effective method for diagnosing breast lesions currently undergoing multicenter evaluation in the USA and Europe. The test analyzes subtle differences in electrical potential caused by dysregulated epithelial proliferation. This report summarizes a prospective evaluation of BBE in a population of 101 patients with suspicious breast lesions scheduled either for open surgical biopsy or fine needle aspiration biopsy. Of the 101 patients included in the study, 49 were found to have a breast malignancy and 52 were found to have a benign breast lesion. BBE correctly identified 44 of 49 biopsy-proven cancers (sensitivity=90%) and correctly indicated no cancer in 31 of 52 biopsy-proven benign cases (specificity=60%). Sensitivity increased to 95% for cancers less than 2.5 cm in size. These results indicate that BBE may be an effective adjunctive test to help to resolve abnormalities discovered by physical examination or other screening methods. PMID:8957069

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

    PubMed Central

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

    2015-01-01

    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. PMID:26130833

  6. A prospective multicenter study evaluating skin tolerance to standard hand hygiene techniques.

    PubMed

    Chamorey, Emmanuel; Marcy, Pierre-Yves; Dandine, Marc; Veyres, Patricia; Negrin, Nadine; Vandenbos, Frederic; Duval, Marie-Josée; Lambert, Sylvain; Mazzoni, Laëtitia; Chapuis, Viviane; Bodokh, Isaac; Sacleux, Paul

    2011-02-01

    We performed a prospective multicenter study to assess the dryness and irritation of the hands in health care facilities, and to evaluate whether that disinfection with an alcohol-based hand rub (ABHR) is better tolerated than classic handwashing with mild soap and water. Our study was conducted in 9 sites in the summer and winter. A team of investigators evaluated dryness and irritation. This study takes into account most of the individual and environmental risk factors (age, sex, use of a protective agent, constitutional factors, personal factors, external factors, institution, function, and number of consecutive working days). The results from the 1932 assessments collected show that traditional handwashing is a risk factor for dryness and irritation, whereas the use of ABHR causes no skin deterioration and might have a protective effect, particularly in intensive use. These results provide a strong argument to counter the rear-guard resistance to the use of ABHRs. PMID:20650547

  7. Laboratory evaluation of the predation efficacy of native Australian fish on Culex annulirostris (Diptera: Culicidae).

    PubMed

    Hurst, Timothy P; Brown, Michael D; Kay, Brian H

    2004-09-01

    The introduction and establishment of fish populations can provide long-term, cost-effective mosquito control in habitats such as constructed wetlands and ornamental lakes. The predation efficacy of 7 native Brisbane freshwater fish on 1st and 4th instars of the freshwater arbovirus vector Culex annulirostris was evaluated in a series of 24-h laboratory trials. The trials were conducted in 30-liter plastic carboys at 25+/-1 degrees C under a light:dark cycle of 14:10 h. The predation efficacy of native crimson-spotted rainbowfish Melanotaenia duboulayi (Melanotaeniidae), Australian smelt Retropinna semoni (Retropinnadae), Pacific blue-eye Pseudomugil signifer (Atherinidae), fly-specked hardyhead Craterocephalus stercusmuscarum (Atherinidae), firetail gudgeon Hypseleotris galii (Eleotridae), empire gudgeon Hypseleotris compressa (Eleotridae), and estuary perchlet Ambassis marianus (Ambassidae) was compared with the exotic eastern mosquitofish Gambusia holbrooki (Poeciliidae). This environmentally damaging exotic has been disseminated worldwide and has been declared noxious in Queensland. Melanotaenia duboulayi was found to consume the greatest numbers of both 1st and 4th instars of Cx. annulirostris. The predation efficacy of the remaining Australian native species was comparable with that of the exotic G. holbrooki. With the exception of A. marianus, the maximum predation rates of these native species were not statistically different whether tested individually or in a school of 6. Based on these data, M. duboulayi, H. compressa, and A. marianus warrant further investigation as biological control agents in pilot field trials. PMID:15532929

  8. 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. PMID:23941272

  9. 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. PMID:25511007

  10. [A comparative evaluation of the efficacy of magneto- and laser therapy in patients with osteoarthrosis deformans].

    PubMed

    Selivonenko, V G; Syvolap, V D; Porada, L V; Medvedeva, V N; Boev, S S; Morozov, A I; Slin'ko, V G; Berest, S M; Garbuz, L N; Sholokh, S G

    1997-01-01

    A comparative evaluation of efficacy of magneto- and laser therapy was carried out in 82 patients with osteoarthrosis deformans. The magnetic field and laser irradiation dispelled the pain syndrome and synovitis manifestations. It is recommendable that the multiple-modality therapy of patients with osteoarthrosis deformans should involve magneto- and laser therapy (15 to 20 procedures per one course) that improve results of the treatment being received and allow the time of hospitalization to be reduced at an average by 5 bed-days. Laser appeared to be a very effective mode of treatment. No unfavourable side effects were recordable. PMID:9491734

  11. 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.

  12. Safety and Efficacy of Dihydroartemisinin-Piperaquine in Falciparum Malaria: A Prospective Multi-Centre Individual Patient Data Analysis

    PubMed Central

    Zwang, Julien; Ashley, Elizabeth A.; Karema, Corine; D'Alessandro, Umberto; Smithuis, Frank; Dorsey, Grant; Janssens, Bart; Mayxay, Mayfong; Newton, Paul; Singhasivanon, Pratap; Stepniewska, Kasia; White, Nicholas J.; Nosten, François

    2009-01-01

    Background The fixed dose antimalarial combination of dihydroartemisinin-piperaquine (DP) is a promising new artemisinin-based combination therapy (ACT). We present an individual patient data analysis of efficacy and tolerability in acute uncomplicated falciparum malaria, from seven published randomized clinical trials conducted in Africa and South East Asia using a predefined in-vivo protocol. Comparator drugs were mefloquine-artesunate (MAS3) in Thailand, Myanmar, Laos and Cambodia; artemether-lumefantrine in Uganda; and amodiaquine+sulfadoxine-pyrimethamine and artesunate+amodiaquine in Rwanda. Methods and Findings In total 3,547 patients were enrolled: 1,814 patients (32% children under five years) received DP and 1,733 received a comparator antimalarial at 12 different sites and were followed for 28–63 days. There was no significant heterogeneity between trials. DP was well tolerated with 1.7% early vomiting. There were less adverse events with DP in children and adults compared to MAS3 except for diarrhea; ORs (95%CI) 2.74 (2.13 to 3.51) and 3.11 (2.31 to 4.18), respectively. DP treatment resulted in a rapid clearance of fever and parasitaemia. The PCR genotype corrected efficacy at Day 28 of DP assessed by survival analysis was 98.7% (95%CI 97.6–99.8). DP was superior to the comparator drugs in protecting against both P.falciparum recurrence and recrudescence (P = 0.001, weighted by site). There was no difference between DP and MAS3 in treating P. vivax co-infections and in suppressing the first relapse (median interval to P. vivax recurrence: 6 weeks). Children under 5 y were at higher risk of recurrence for both infections. The proportion of patients developing gametocytaemia (P = 0.002, weighted by site) and the subsequent gametocyte carriage rates were higher with DP (11/1000 person gametocyte week, PGW) than MAS3 (6/1000 PGW, P = 0.001, weighted by site). Conclusions DP proved a safe, well tolerated, and highly effective treatment of P

  13. Efficacy and Safety of Corneal Transplantation Using Corneas from Foreign Donors versus Domestic Donors: A Prospective, Randomized, Controlled Trial

    PubMed Central

    Chen, Yingxin; Liao, Congling; Gao, Minghong; Belin, Michael Wellington; Wang, Mingwu; Yu, Hai; Yu, Jing

    2015-01-01

    Purpose. To assess the efficacy and safety of corneal transplantation using corneas from foreign donors. Methods. One hundred and eight patients needing therapeutic penetrating keratoplasty were randomly divided into 2 groups (54 cases/group): foreign group using foreign donor corneas and domestic group using domestic donor corneas. Clinical outcome and incidence of postoperative complications were compared between groups. Results. No significant difference with respect to the therapeutic outcome and postoperative Best Corrected Visual Acuity (BCVA) and neovascularization by final follow-up was observed between the two groups. The graft thickness in the foreign group was statistically higher than the domestic group at 1 month postoperatively, but not at 3, 6, and 12 months postoperatively. Corneal endothelial cell density in the domestic group was statistically higher than in the foreign group at 3, 6, and 12 months postoperatively. Corneal epithelial abnormalities in the foreign group were significantly higher than that in domestic group. The primary graft failure, incidence of graft survival, and postoperative complications such as immunologic rejection, graft infection, and secondary glaucoma were not significantly different between the two groups. Conclusions. Corneal transplantations using foreign donor corneas are as effective and safe as those using domestic donor corneas. PMID:25694823

  14. The efficacy of peritubal analgesic infiltration in postoperative pain following percutaneous nephrolithotomy – A prospective randomized controlled study

    PubMed Central

    Lojanapiwat, Bannakij; Chureemas, Tanarit; Kittirattarakarn, Pruit

    2015-01-01

    ABSTRACT Objective: To study the efficacy of peritubal infiltration in postoperative pain following percutaneous nephrolithotomy in general PCNL patients and PCNL patients with supracostal renal access. Patients and Methods: A total of 105 PCNL patients were randomized into two groups, 53 patients receiving peritubal analgesic infiltration (study group) and 52 patients as the control group. Of these patients, supracostal access was performed in 22 patients of study group and 23 patients of control group. The study group received peritubal injection with 10mL of bupivacain. Postoperative pain as the primary outcome was assessed by using visual analogue scale at 1, 4, 12, 24 and 48 hours postoperatively. The secondary outcomes were the total postoperative morphine usage in 24 hours and time of the first analgesic demand. Results: The average VAS pain at 1 and 4 hours after the operation in the study group were significant lower in the control group (P≤0.001 and 0.026). Doses of morphine usage for controlling postoperative pain and the first analgesic demand were significantly lower and longer in study group. Among patients submitted to supracostal access, the average VAS pain at 1 hour after operation in the study group was lower (P=0.018). Doses of morphine usage for controlling postoperative pain also was lower in the study group (P=0.012). Conclusion: The peritubal local anesthetic infiltration is effective in alleviating immediate postoperative pain after percutaneous nephrolithotomy even with supracostal access. PMID:26689520

  15. 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

  16. 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

  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. PMID:22203840

  18. Safety and Efficacy of Botulinum Toxin to Preserve Gland Function after Radiotherapy in Patients with Head and Neck Cancer: A Prospective, Randomized, Placebo-Controlled, Double-Blinded Phase I Clinical Trial

    PubMed Central

    Teymoortash, Afshin; Pfestroff, Andreas; Wittig, Andrea; Franke, Nora; Hoch, Stephan; Harnisch, Susanne; Schade-Brittinger, Carmen; Hoeffken, Helmut; Engenhart-Cabillic, Rita; Brugger, Markus; Strauch, Konstantin

    2016-01-01

    This prospective, randomized, placebo-controlled, double-blinded phase I clinical trial investigates safety and efficacy of botulinum toxin (BoNT) to preserve gland function after radiotherapy in patients with head and neck cancer. Twelve patients with advanced head and neck cancer were injected with BoNT into the submandibular glands prior to primary radiochemotherapy. Six patients received BoNT/A and 6 patients BoNT/A and B, half of each subgroup into their left and the other half into their right gland. As an internal control, sodium chloride was injected into the respective contralateral gland (placebo). For the evaluation of the salivary gland function, technetium pertechnetate salivary gland scintigraphy was performed before and after the end of radiotherapy. BoNT/A and B were well tolerated. Analysis of the scintigraphic data revealed no statistically significant difference between BoNT and placebo regarding the scintigraphic uptake difference (pBoNT/A = 0.84 and pBoNT/A-B = 0.56 for BoNT/A vs. placebo and BoNT/A-B vs. placebo, respectively). We also found no significant difference in treatment between BoNT and placebo in terms of salivary excretion fraction (pBoNT/A = 0.44; pBoNT/A-B = 0.44). This study demonstrates that BoNT can be safely combined with radiochemotherapy. Dosing and timing of BoNT injection should be further investigated for efficacy analysis. Trial Registration German Registry for Clinical Trails DRKS00004595 PMID:26991494

  19. Efficacy of orally disintegrating film of ondansetron versus intravenous ondansetron in prophylaxis of postoperative nausea and vomiting in patients undergoing elective gynaecological laparoscopic procedures: A prospective randomised, double-blind placebo-controlled study

    PubMed Central

    Hegde, Harihar V; Yaliwal, Vijay G; Annigeri, Rashmi V; Sunilkumar, KS; Rameshkumar, R; Rao, P Raghavendra

    2014-01-01

    Background and Aims: Ondansetron is one of the most widely used drugs for postoperative nausea and vomiting (PONV) prophylaxis. Orally disintegrating film (ODF) formulations are relatively recent innovations. We evaluated the efficacy of ODF of ondansetron for the prophylaxis of PONV. Methods: One hundred and eighty American Society of Anaesthesiologists-I or II women, in the age group 18-65 years, scheduled for elective gynaecological laparoscopic procedures were studied in a prospective randomised, double-blind, placebo-controlled trial. The patients were randomised into four groups: Placebo, intravenous (IV) ondansetron 4 mg, ODF of ondansetron 4 mg (ODF4) and 8 mg (ODF8) groups. PONV was assessed in two epochs of 0-6 and 7-24 h. Primary outcome measure was the incidence of PONV and secondary outcome measures were severity of nausea, need for rescue anti-emetic, analgesic consumption, time to oral intake, overall patient satisfaction and side effects such as headache and dizziness. PONV was compared using analysis of variance or Mann–Whitney U-test as applicable. Results: Data of 173 patients were analysed. The incidence of postoperative nausea was significantly lower (P = 0.04) only during the 0-6 h in the ODF8 group when compared with the placebo group. During the 0-6 h interval postoperatively, the ODF8 group had a significantly lower incidence of vomiting when compared with the placebo (P = 0.002) and the IV group (P = 0.044). During the 0-24 h interval postoperatively, ODF4 (P = 0.01) and ODF8 (P = 0.002) groups had a significantly lower incidence of vomiting compared to the placebo group. Conclusions: Orally disintegrating film of ondansetron is an efficacious, novel, convenient and may be a cost-effective option for the prophylaxis of PONV. PMID:25197110

  20. Efficacy and safety of once-monthly injection of paliperidone palmitate in hospitalized Asian patients with acute exacerbated schizophrenia: an open-label, prospective, noncomparative study

    PubMed Central

    Li, HuaFang; Turkoz, Ibrahim; Zhang, Fan

    2016-01-01

    Introduction This single-group, open-label, prospective, noncomparative, multicenter, Phase IV study explored the efficacy and tolerability of paliperidone palmitate (PP) in hospitalized patients with acute exacerbation of schizophrenia. Methods Asian patients of either sex, between 18 and 65 years of age, diagnosed with schizophrenia (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) with acute exacerbations within the previous 4 weeks, were enrolled. Intramuscular PP was initiated at doses of 150 milligram equivalent (mg eq) (day 1) and 100 mg eq (day 8), followed by a monthly maintenance dose between 75 mg eq and 150 mg eq (days 36 and 64). Primary efficacy endpoint was the change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score (last-observation-carried-forward) at week 13. Results Of the 212 enrolled patients, 152 (71.7%) completed the 13-week treatment; withdrawal of consent (24 [11.3%] patients) was the most common reason for study discontinuation. Mean (standard deviation) PANSS total score from baseline (90.0 [17.41]) improved significantly at day 4 (−6.1 [9.27]; 95% confidence interval: −7.38, −4.85; P<0.001) and week 13 endpoint (−23.9 [23.24]; 95% confidence interval: −27.10, −20.78; P<0.001). Similarly, the secondary endpoints (Clinical Global Impression-Severity, Physical and Social Performance, each PANSS subscale, and Marder factor scores) improved significantly from baseline to week 13 endpoint (P<0.001 for all). At week 13, 112/210 (53.3%) patients had a 40% improvement in the PANSS total score (responder rate), and 133/212 (62.7%) patients were ready for hospital discharge. Overall, 139 (65.6%) patients experienced at least one treatment-emergent adverse event (TEAE). Most common (>5%) TEAEs were hyperprolactinemia, constipation, nasopharyngitis, insomnia, increased weight, and tremor. Worsening of schizophrenia (3.3%) and sinus bradycardia (2.0%) were serious TEAEs; no deaths were

  1. 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

  2. Evaluating efficacy of bacteriophage therapy against Staphylococcus aureus infections using a silkworm larval infection model.

    PubMed

    Takemura-Uchiyama, Iyo; Uchiyama, Jumpei; Kato, Shin-ichiro; Inoue, Tetsuyoshi; Ujihara, Takako; Ohara, Naoya; Daibata, Masanori; Matsuzaki, Shigenobu

    2013-10-01

    Silkworm larva has recently been recognized as an alternative model animal for higher mammals to evaluate the effects of antibiotics. In this study, we examined the efficacy of the bacteriophage (phage) therapy, which harnesses phages as antibacterial agents, against Staphylococcus aureus infections, using the silkworm larval infection model. Two newly isolated staphylococcal phages, S25-3 and S13', were used as therapeutic phage candidates. They were assigned to two different lytic phage genera, Twort-like and AHJD-like viruses, based on their morphologies and the N-terminal amino acid sequences of the major capsid proteins. Both had a broad host range and strong lytic activity and showed preservative quality. Administration of these phages alone caused no adverse effects in the silkworm larvae. Moreover, the viruses showed life-prolonging effects in the silkworm larval infection model 10 min, 6 h, 12 h, and 24 h following infection. Such phage effects in the silkworm larval model were almost paralleled to the therapeutic efficacies in mouse models. These results suggest that phages S25-3 and S13' are eligible as therapeutic candidates and that the silkworm larval model is valid for the evaluation of phage therapy as well as mouse models. PMID:23869440

  3. Evaluation of the therapeutic efficacy of different levothyroxine preparations in the treatment of human thyroid disease.

    PubMed

    Klein, Irwin; Danzi, Sara

    2003-12-01

    At the present time, optimal therapy for hypothyroidism requires replacement of the deficiency in thyroid hormone with synthetic levothyroxine. Precise titration of this narrow therapeutic index drug is necessary to return the patient to a chemically and clinically euthyroid state. Seven levothyroxine formulations are Food and Drug Administration (FDA)-approved and four are available to the physician. Proper dosage is established based on thyrotropin (TSH) testing and clinical evaluation. Each levothyroxine preparation must comply with FDA standards for bioavailability but may vary with respect to its dissolution and absorption properties and are not interchangeable. This equivalence testing is done on normal volunteers and requires a suprapharmacologic dose of levothyroxine in order to make the determination of bioavailability. In this review we discuss the various methods to evaluate therapeutic efficacy and bioequivalence of levothyroxine preparations in the treatment of thyroid disease. These are relevant to the physician and patient because small differences in the efficacy can produce unwanted effects of either underreplacement or overreplacement. PMID:14751033

  4. Randomized, prospective, three-arm study to confirm the auditory safety and efficacy of artemether-lumefantrine in Colombian patients with uncomplicated Plasmodium falciparum malaria.

    PubMed

    Carrasquilla, Gabriel; Barón, Clemencia; Monsell, Edwin M; Cousin, Marc; Walter, Verena; Lefèvre, Gilbert; Sander, Oliver; Fisher, Laurel M

    2012-01-01

    The safety of artemether-lumefantrine in patients with acute, uncomplicated Plasmodium falciparum malaria was investigated prospectively using the auditory brainstem response (ABR) and pure-tone thresholds. Secondary outcomes included polymerase chain reaction-corrected cure rates. Patients were randomly assigned in a 3:1:1 ratio to either artemether-lumefantrine (N = 159), atovaquone-proguanil (N = 53), or artesunate-mefloquine (N = 53). The null hypothesis (primary outcome), claiming that the percentage of patients with a baseline to Day-7 ABR Wave III latency increase of > 0.30 msec is ≥ 15% after administration of artemether-lumefantrine, was rejected; 2.6% of patients (95% confidence interval: 0.7-6.6) exceeded 0.30 msec, i.e., significantly below 15% (P < 0.0001). A model-based analysis found no apparent relationship between drug exposure and ABR change. In all three groups, average improvements (2-4 dB) in pure-tone thresholds were observed, and polymerase chain reaction-corrected cure rates were > 95% to Day 42. The results support the continued safe and efficacious use of artemether-lumefantrine in uncomplicated falciparum malaria. PMID:22232454

  5. The efficacy of music therapy protocols for decreasing pain, anxiety, and muscle tension levels during burn dressing changes: a prospective randomized crossover trial.

    PubMed

    Tan, Xueli; Yowler, Charles J; Super, Dennis M; Fratianne, Richard B

    2010-01-01

    The purpose of this study was to explore the efficacy of two music therapy protocols on pain, anxiety, and muscle tension levels during dressing changes in burn patients. Twenty-nine inpatients participated in this prospective, crossover randomized controlled trial. On two consecutive days, patients were randomized to receive music therapy services either on the first or second day of the study. On control days, they received no music. On music days, patients practiced music-based imagery (MBI), a form of music-assisted relaxation with patient-specific mental imagery before and after dressing changes. Also, on music days during dressing changes, the patients engaged in music alternate engagement (MAE), which consisted of active participation in music making. The dependent variables were the patients' subjective ratings of their pain and anxiety levels and the research nurse's objective ratings of their muscle tension levels. Two sets of data were collected before, three sets during, and another two sets after dressing changes. The results showed significant decrease in pain levels before (P < .025), during (P < .05), and after (P < .025) dressing changes on days the patients received music therapy in contrast to control days. Music therapy was also associated with a decrease in anxiety and muscle tension levels during the dressing changes (P < .05) followed by a reduction in muscle tension levels after dressing changes (P < .025). Music therapy significantly decreases the acute procedural pain, anxiety, and muscle tension levels associated with daily burn care. PMID:20498613

  6. Randomized, Prospective, Three-Arm Study to Confirm the Auditory Safety and Efficacy of Artemether-Lumefantrine in Colombian Patients with Uncomplicated Plasmodium falciparum Malaria

    PubMed Central

    Carrasquilla, Gabriel; Barón, Clemencia; Monsell, Edwin M.; Cousin, Marc; Walter, Verena; Lefèvre, Gilbert; Sander, Oliver; Fisher, Laurel M.

    2012-01-01

    The safety of artemether-lumefantrine in patients with acute, uncomplicated Plasmodium falciparum malaria was investigated prospectively using the auditory brainstem response (ABR) and pure-tone thresholds. Secondary outcomes included polymerase chain reaction-corrected cure rates. Patients were randomly assigned in a 3:1:1 ratio to either artemether-lumefantrine (N = 159), atovaquone-proguanil (N = 53), or artesunate-mefloquine (N = 53). The null hypothesis (primary outcome), claiming that the percentage of patients with a baseline to Day-7 ABR Wave III latency increase of > 0.30 msec is ≥ 15% after administration of artemether-lumefantrine, was rejected; 2.6% of patients (95% confidence interval: 0.7–6.6) exceeded 0.30 msec, i.e., significantly below 15% (P < 0.0001). A model-based analysis found no apparent relationship between drug exposure and ABR change. In all three groups, average improvements (2–4 dB) in pure-tone thresholds were observed, and polymerase chain reaction-corrected cure rates were > 95% to Day 42. The results support the continued safe and efficacious use of artemether-lumefantrine in uncomplicated falciparum malaria. PMID:22232454

  7. 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

  8. 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

    Pirard, Céline; Loumaye, Ernest; Laurent, Pascale; 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

  9. Clinical evaluation of neutron beam therapy. Current results and prospects, 1983

    SciTech Connect

    Cohen, L.; Hendrickson, F.R.; Kurup, P.D.; Mansell, J.A.; Awschalom, M.; Rosenberg, I.; Ten Haken, R.K.

    1985-01-01

    Some 9000 patients throughout the world have been treated by some form of neutron beam therapy. These include patients with advanced nonresectable tumors in many different sites treated with a variety of neutron beam generators varying widely in beam energy. Protocols were largely nonrandomized and included both mixed beam studies (neutrons + photons) and neutrons alone in varying doses. In spite of wide variation in equipment, treatment technique, and philosophy, some consistent trends have been identified: (1) in general, the neutron results have been at least as good as those of the photon controls measured in terms of local control, although the incidence of significant side effects have been higher; (2) in none of the randomized studies conducted so far, largely comprising epidermoid carcinomas of the head and neck, has a clear survival advantage for neutrons over photon controls been demonstrated at a statistically significant level; (3) results with mixed beam studies have been uniformly equivocal, with marginally significant differences in favor of the experimental groups compared with the photon controls; (4) adenocarcinomas of the gastrointestinal tract (GI) tract, including tumors of the salivary gland, pancreas, stomach, and bowel, appear to be responsive to high linear energy transfer (LET) radiation; (5) nonepidermoid, radioresistant tumors (sarcoma of bone and soft tissue and melanoma) yield a consistantly high local control rate, with neutron irradiation strikingly superior to those reported with photon therapy; and (6) in the central nervous system, both normal tissues and tumors appear to be exceptionally sensitive to neutron irradiation, therapeutic ratios are small, and the prospect of cure remains remote. It is concluded that neutrons are efficacious for certain specific tumor types, but that essentially new study designs, based on nonrandomized matched case comparisons, will be required to prove the merit of the new modality.

  10. 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

  11. Efficacy of mesotherapy in facial rejuvenation: a histological and immunohistochemical evaluation

    PubMed Central

    El-Domyati, Moetaz; El-Ammawi, Tarek S.; Moawad, Osama; El-Fakahany, Hasan; Medhat, Walid; Mahoney, Mỹ G.; Uitto, Jouni

    2012-01-01

    Background Mesotherapy, commonly known as “biorejuvenation” or “biorevitalization”, is a technique used to rejuvenate the skin by means of a transdermal injection of a multivitamin solution and natural plant extracts that are thought to improve the signs of skin aging. Objectives This prospective study aimed to evaluate the clinical effect of mesotherapy applied to periorbital wrinkles and to quantitatively evaluate histological changes in the skin occurring in response to the same treatment. Methods Six volunteers with Fitzpatrick skin types III or IV and Glogau class I–III wrinkles were subjected to a three-month course of mesotherapy injections in the periocular area (six sessions administered at two-week intervals). Standard photographs and skin biopsies were obtained from the treatment area at baseline, at the end of treatment, and at three months post-treatment. Quantitative evaluation of collagen types I, III, and VII, newly synthesized collagen, total elastin, and tropoelastin was performed using a computerized morphometric analysis. Results The clinical evaluation of volunteers at baseline, end of treatment, and three months post-treatment revealed no significant differences. Histological and immunostaining analysis of collagen types I, III, and VII, newly synthesized collagen, total elastin, and tropoelastin showed no statistically significant changes (P > 0.05) after mesotherapy injection. Conclusions The present study indicates that mesotherapy for skin rejuvenation does not result in statistically significant histological changes or clinical improvement. PMID:22788806

  12. 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.

  13. Evaluation of efficacy of enamel matrix derivative in the treatment of intrabony defects: a 24-month multicenter study.

    PubMed

    Francetti, Luca; Trombelli, Leonardo; Lombardo, Giorgio; Guida, Luigi; Cafiero, Carlo; Roccuzzo, Mario; Carusi, Giorgio; Del Fabbro, Massimo

    2005-10-01

    The aim of this prospective multicenter controlled clinical study was to evaluate the efficacy of Emdogain (Biora), an enamel matrix derivative (EMD), when combined with surgical treatment of periodontal angular defects, as compared to surgery alone, for up to 24 months of follow-up. The study was performed at six Italian universities and 11 private practices. Patients with one-, two-, or three-wall angular defects were enrolled if intrabony defect depth (IBD) was 4 mm or more and probing pocket depth (PPD) was at least 6 mm. They were randomly allocated to either test or control groups. The test group was treated by the simplified papilla preservation (SPP) flap plus Emdogain after root conditioning with ethylenediaminetetraacetic acid. The control group was treated by SPP alone. Plaque Index, Gingival Index, PPD, and periodontal attachment level (PAL) at surgical sites were assessed at the presurgical examination (baseline). IBD was measured intraoperatively after debridement. IBD was also evaluated with a computer-aided technique, from periapical radiographs. Plaque Index, Gingival Index, PPD, PAL, and IBD were assessed at 12 and 24 months postsurgery. Data were further divided in two subgroups according to baseline IBD (6 mm or less and more than 6 mm). The differences between each follow-up and baseline, and between groups at each follow-up, for the above parameters were evaluated by standard statistical methods. One hundred fifty-three patients were recruited, accounting for 195 intrabony defects: 83 patients (108 defects) and 70 patients (87 defects) were allocated to the test and control groups, respectively. All parameters were improved at both 12 and 24 months, compared to baseline in both groups. In the test group, IBD, PPD, and PAL at 12 months were significantly better than these parameters in the control group. The test subgroup with IBD of more than 6 mm at baseline displayed a better outcome when compared to the 6 mm or less IBD subgroup. No

  14. 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

  15. The Efficiency and Efficacy of the Evaluation Practices of the Illinois Division of Vocational and Technical Education--Final Report.

    ERIC Educational Resources Information Center

    Norton, Daniel P.; Watley, Donivan J.

    A study of the "efficiency and efficacy" of evaluation practices of the Illinois Division of Vocational and Technical Education as conducted by Educational Testing Service is reported on. The study was directed toward understanding how evaluation practices of the Division, with largest emphasis upon the performance of the Three Phase System used…

  16. 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

  17. Evaluating the Efficacy of Endoscopic Thoracic Sympathectomy for Generalized Social Anxiety Disorder with Blushing Complaints

    PubMed Central

    Súarez, Claudio; Palacios, Estela; Palacios, Fernanda; Matus, Patricia

    2011-01-01

    Objective: No study has yet compared the efficacy of endoscopic thoracic sympathectomy for treating facial blushing with other treatment or no treatment. We conducted a prospective, observational, open-label, clinical study to compare endoscopic thoracic sympathectomy for blushing with generalized social anxiety disorder versus sertraline treatment and no treatment. Method: Three-hundred and thirty consecutive patients seeking treatment for their blushing were assessed by psychiatric interview and patient-rated scales. The Brief Social Phobia Scale was the primary outcome measure. Patients meeting Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition criteria for generalized social anxiety disorder, scoring 20 points or more in the Brief Social Phobia Scale and 19 points or more in the Social Phobia Inventory were considered eligible and followed up for a mean of 11 months (range 1–64) after endoscopic thoracic sympathectomy or initiation of sertraline. Results: At baseline, 97 percent of the endoscopic thoracic sympathectomy-treated group, 87 percent of the sertraline-treated group, and 78 percent of the nontreated group rated their blushing as being “severe” or “extreme.” At follow up, 16 percent of endoscopic thoracic sympathectomy-treated patients, 32 percent of sertraline-treated patients, and 57 percent of untreated patients reported this degree of blushing. At endpoint, Brief Social Phobia Scale total scores exhibited a greater decline with either treatment than with no treatment. Nonetheless, in comparison to no treatment, only the results obtained with endoscopic thoracic sympathectomy achieved statistical significance (p=0.003). Compensatory sweating occurred in 99 percent of patients who underwent endoscopic thoracic sympathectomy. High degrees of satisfaction with treatment were reported by 89 percent of patients undergoing endoscopic thoracic sympathectomy and by 59 percent of patients taking medication. Conclusion

  18. 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. PMID:24240607

  19. A Critical Approach to Evaluating Clinical Efficacy, Adverse Events and Drug Interactions of Herbal Remedies.

    PubMed

    Izzo, Angelo A; Hoon-Kim, Sung; Radhakrishnan, Rajan; Williamson, Elizabeth M

    2016-05-01

    Systematic reviews and meta-analyses represent the uppermost ladders in the hierarchy of evidence. Systematic reviews/meta-analyses suggest preliminary or satisfactory clinical evidence for agnus castus (Vitex agnus castus) for premenstrual complaints, flaxseed (Linum usitatissimum) for hypertension, feverfew (Tanacetum partenium) for migraine prevention, ginger (Zingiber officinalis) for pregnancy-induced nausea, ginseng (Panax ginseng) for improving fasting glucose levels as well as phytoestrogens and St John's wort (Hypericum perforatum) for the relief of some symptoms in menopause. However, firm conclusions of efficacy cannot be generally drawn. On the other hand, inconclusive evidence of efficacy or contradictory results have been reported for Aloe vera in the treatment of psoriasis, cranberry (Vaccinium macrocarpon) in cystitis prevention, ginkgo (Ginkgo biloba) for tinnitus and intermittent claudication, echinacea (Echinacea spp.) for the prevention of common cold and pomegranate (Punica granatum) for the prevention/treatment of cardiovascular diseases. A critical evaluation of the clinical data regarding the adverse effects has shown that herbal remedies are generally better tolerated than synthetic medications. Nevertheless, potentially serious adverse events, including herb-drug interactions, have been described. This suggests the need to be vigilant when using herbal remedies, particularly in specific conditions, such as during pregnancy and in the paediatric population. Copyright © 2016 John Wiley & Sons, Ltd. PMID:26887532

  20. Comparative efficacy evaluation of moxidectin gel and ivermectin paste against internal parasites of equines in Brazil.

    PubMed

    Costa, A J; Barbosa, O F; Moraes, F R; Acuña, A H; Rocha, U F; Soares, V E; Paullilo, A C; Sanches, A

    1998-12-15

    A total of 24 male and female equines of mixed breed, 10-20 months of age and naturally infected with internal parasites was utilized in a controlled test to evaluate the efficacy of a moxidectin 2% gel formulation at the dosage of 0.4 mg moxidectin per kg of live weight and an ivermectin 1.87% commercial paste formulation at the dosage 0.2 mg ivermectin per kg applied orally. Animals were allocated into three groups of eight horses each based on pre-treatment eggs per gram (EPG) counts and treatments were randomized among the groups. One group was kept as untreated controls. One animal in the moxidectin-treated group died before the end of the trial from a cause unrelated to treatment leaving a total of seven animals in this group. Fecal egg counts were performed three times post-treatment and the number of parasites remaining in each animal was determined. Statistical analyses using geometric means were performed at the 1% level of significance. Both moxidectin and ivermectin preparations reduced initial EPG from a mean of 1600 to 0 on Days 5, 7 and at the end of the trial on Day 14. Efficacy percentages of moxidectin and ivermectin against immature and adult nematodes were as follows: Trichostrongylus axei, Parascaris equorum, Strongylus edentatus, S. vulgaris, Triodontophorus spp. and Gyalocephalus capitatus, 100% for both products; Habronema muscae 99.5 and 99.6%, respectively, Strongyloides westeri, 100 and 99.2%, respectively; Oxyuris equi, 99.6 and 100%, respectively; small strongyles, 99.7% for both products. Of the latter, the most numerous were: Cylicocyclus insigne, Cylicostephanus longibursatus and Cyathostomum catinatum. No Gasterophilus nasalis were found in horses from either treated group, while two of eight control horses had infections with thisparasite. Moxidectin showed greater efficacy (84.9%) than ivermectin (67.8%) against Strongylus vulgaris larvae found in the mesenteric artery aneurisms, but the difference was not statistically

  1. 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.

  2. A PROSPECTIVE EVALUATION OF THE DIRECTIONALITY OF THE DEPRESSION-INFLAMMATION RELATIONSHIP

    PubMed Central

    Stewart, Jesse C.; Rand, Kevin L.; Muldoon, Matthew F.; Kamarck, Thomas W.

    2009-01-01

    Cross-sectional studies have found that individuals with depressive disorders or symptoms have elevated levels of inflammatory markers predictive of coronary artery disease, including interleukin-6 (IL-6) and C-reactive protein (CRP). Due to the paucity of prospective studies, however, the directionality of the depression-inflammation relationship is unclear. We evaluated the longitudinal associations between depressive symptoms and both IL-6 and CRP among 263 healthy, older men and women enrolled in the Pittsburgh Healthy Heart Project, a 6-year prospective cohort study. During the baseline and follow-up visits, participants completed the Beck Depression Inventory-II (BDI-II) to assess depressive symptoms and underwent blood draws to quantify serum IL-6 and CRP. Path analyses revealed that baseline BDI-II (β=.18, p <.01, ΔR2 =.02) was a predictor of 6-year change in IL-6, even after adjustment for demographic, biomedical, and behavioral factors as well as other negative emotions. Of all the factors examined, only body-mass index was a stronger predictor of IL-6 change than depressive symptoms. In contrast to these results, baseline IL-6 did not predict 6-year change in BDI-II. Evidence of a weak bidirectional relationship between BDI-II and CRP was also observed; however, neither of these longitudinal associations was significant. The present findings indicate that depressive symptoms may precede and augment some inflammatory processes relevant to coronary artery disease among healthy, older adults. Therefore, our results imply that depression may lead to inflammation and that inflammation may be one of the mechanisms through which depression contributes to cardiovascular risk. PMID:19416750

  3. 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…

  4. Technological Culture and the Human Prospect: An Evaluation of a New Undergraduate Interdisciplinary Team-Taught Course.

    ERIC Educational Resources Information Center

    Counelis, James Steve

    An evaluation of an undergraduate interdisciplinary team-taught course entitled "Technological Culture and the Human Prospect" is presented. The pilot course attempts to deal with (1) the need for curricular innovation, (2) the need for faculty development, (3) the need to build flexible curricula with greater sensitivity for student motivation…

  5. 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

  6. 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

  7. Evaluation of prenatal-onset osteochondrodysplasias by ultrasonography: a retrospective and prospective analysis.

    PubMed

    Krakow, Deborah; Alanay, Yasemin; Rimoin, Lauren P; Lin, Victoria; Wilcox, William R; Lachman, Ralph S; Rimoin, David L

    2008-08-01

    The osteochondrodysplasias or skeletal dysplasias are a heterogenous group of over 350 distinct disorders of skeletogenesis. Many manifest in the prenatal period, making them amenable to ultrasound prenatal diagnosis. A retrospective analysis evaluated 1,500 cases referred to the International Skeletal Dysplasia Registry (ISDR) to determine the relative frequency of specific osteochondrodysplasias and correlation of ultrasound versus radiographic diagnoses for these disorders. Within the retrospective cohort of 1,500 cases, 85% of the referred cases represented well-defined skeletal dysplasias, and the other 15% of cases were a mixture of genetic syndromes and probable early-onset intrauterine growth restriction. The three most common prenatal-onset skeletal dysplasias were osteogenesis imperfecta type 2, thanatophoric dysplasia and achondrogenesis 2, accounting for almost 40% of the cases. In a prospective analysis of 500 cases using a standardized ultrasound approach to the evaluation of these disorders, the relative frequencies of osteogenesis imperfecta type 2, thanatophoric dysplasia and achondrogenesis 2 were similar to the retrospective analysis. This study details the relative frequencies of specific prenatal-onset osteochondrodysplasias, their heterogeneity of prenatal-onset skeletal disorders and provides a standardized prenatal ultrasound approach to these disorders which should aid in the prenatal diagnosis of fetuses suspected of manifesting skeletal dysplasias. PMID:18627037

  8. 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.

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

    PubMed

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

    2015-03-01

    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. PMID:25597861

  10. The efficacy of minimally invasive discectomy compared with open discectomy: a meta-analysis of prospective randomized controlled trials

    PubMed Central

    Dasenbrock, Hormuzdiyar H.; Juraschek, Stephen P.; Schultz, Lonni R.; Witham, Timothy F.; Sciubba, Daniel M.; Wolinsky, Jean-Paul; Gokaslan, Ziya L.; Bydon, Ali

    2013-01-01

    Object Advocates of minimally invasive discectomy (MID) have promoted this operation as an alternative to open discectomy (OD), arguing that there may be less injury to the paraspinal muscles, decreased postoperative pain, and a faster recovery time. However, a recently published large randomized controlled trial (RCT) comparing these approaches reported inferior relief of leg pain in patients undergoing MID. The authors conducted a meta-analysis to evaluate complications and improvement in leg pain in patients with radiculopathy enrolled in RCTs comparing OD to MID. Methods The authors performed a literature search using Medline and EMBASE of studies indexed between January 1990 and January 2011. Predetermined RCT eligibility included the usage of tubular retractors during MID, a minimum follow-up duration of 1 year, and quantification of pain with the visual analog scale (VAS). Trials that only evaluated patients with recurrent disc herniation were excluded. Data on operative parameters, complications, and VAS scores of leg pain were extracted by 2 investigators. A meta-analysis was performed assuming random effects to determine the difference in mean change for continuous outcomes and the risk ratio for binary outcomes. Results Six trials comprising 837 patients (of whom 388 were randomized to MID and 449 were randomized to OD) were included. The mean operative time was 49 minutes during MID and 44 minutes during OD; this difference was not statistically significant. Incidental durotomies occurred significantly more frequently during MID (5.67% compared with 2.90% for OD; RR 2.05, 95% CI 1.05–3.98). Intraoperative complications (incidental durotomies and nerve root injuries) were also significantly more common in patients undergoing MID (RR 2.01, 95% CI 1.07–3.77). The mean preoperative VAS score for leg pain was 6.9 in patients randomized to MID and 7.2 in those randomized to OD. With long-term follow-up (1–2 years postoperatively), the mean VAS score

  11. The safety and efficacy of irreversible electroporation for the ablation of prostate cancer: a multicentre prospective human in vivo pilot study protocol

    PubMed Central

    van den Bos, W; de Bruin, D M; Muller, B G; Varkarakis, I M; Karagiannis, A A; Zondervan, P J; Laguna Pes, M P; Veelo, D P; Savci Heijink, C D; Engelbrecht, M R W; Wijkstra, H; de Reijke, T M; de la Rosette, J J M C H

    2014-01-01

    Introduction Current surgical and ablative treatment options for prostate cancer have a relatively high incidence of side effects, which may diminish the quality of life. The side effects are a consequence of procedure-related damage of the blood vessels, bowel, urethra or neurovascular bundle. Ablation with irreversible electroporation (IRE) has shown to be effective in destroying tumour cells and harbours the advantage of sparing surrounding tissue and vital structures. The aim of the study is to evaluate the safety and efficacy and to acquire data on patient experience of minimally invasive, transperineally image-guided IRE for the focal ablation of prostate cancer. Methods and analysis In this multicentre pilot study, 16 patients with prostate cancer who are scheduled for a radical prostatectomy will undergo an IRE procedure, approximately 30 days prior to the radical prostatectomy. Data as adverse events, side effects, functional outcomes, pain and quality of life will be collected and patients will be controlled at 1 and 2 weeks post-IRE, 1 day preprostatectomy and postprostatectomy. Prior to the IRE procedure and the radical prostatectomy, all patients will undergo a multiparametric MRI and contrast-enhanced ultrasound of the prostate. The efficacy of ablation will be determined by whole mount histopathological examination, which will be correlated with the imaging of the ablation zone. Ethics and dissemination The protocol is approved by the ethics committee at the coordinating centre (Academic Medical Center (AMC) Amsterdam) and by the local Institutional Review Board at the participating centres. Data will be presented at international conferences and published in peer-reviewed journals. Conclusions This pilot study will determine the safety and efficacy of IRE in the prostate. It will show the radiological and histopathological effects of IRE ablations and it will provide data to construct an accurate treatment planning tool for IRE in prostate

  12. Students as Evaluators in Practicum: Examining Peer/Self Assessment and Self-Efficacy.

    ERIC Educational Resources Information Center

    Fitzpatrick, Corine

    This study explores peer assessment and self-efficacy in a counseling practicum. Data was gathered on the perceptions of practicum students, in their second year of a master's program, with regard to the counseling competencies of their peers and themselves. Counselor self-efficacy was measured using the Counselor Self-Efficacy Rating Scale.…

  13. 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. PMID:26537779

  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. PMID:21872682

  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. Usefulness and problems of the urinary tract infection criteria for evaluating drug efficacy for complicated urinary tract infections.

    PubMed

    Arakawa, Soichi; Tanaka, Kazushi; Miura, Tetsuya; Shigemura, Katsumi; Takenaka, Atsushi; Matsui, Takashi; Kamidono, Sadao; Nakano, Yuzo; Fujisawa, Masato

    2007-10-01

    We aimed to reveal the usefulness of and problematic points with the Criteria for evaluation of clinical efficacy of antimicrobial agents on urinary tract infection (draft fourth edition) proposed by the UTI Subcommittee of the Clinical Evaluation Guidelines Committee, Japan Society of Chemotherapy, for evaluating antimicrobial agents for complicated urinary tract infections. We conducted a multicenter trial involving 159 patients with complicated urinary tract infections without indwelling urinary catheters. The antimicrobial agents used were cefcapene pivoxil and levofloxacin. "Early evaluation" took place the day after completion of 7 days of therapy; "late evaluation" took place 5-9 days after the end of treatment, and "follow-up evaluation" was done 4-6 weeks after treatment. In the early evaluation, overall clinical efficacy was judged as excellent in 52.9% of the patients, moderate in 26.1%, and poor in 21.0%, and the bacteriological response was judged as "eradicated" for 86.4% of the 198 bacterial strains isolated. Of 96 patients included in the "late evaluation" category in accordance with the draft fourth edition, the clinical outcome was judged as "cured" in 68.4% and the microbiological outcome was judged as "eradicated" in 59.4%. These rates may be low, because 25 patients in whom clinical efficacy was evaluated as "poor" at the end of treatment were separately classified as "failed" at the late evaluation. Of the 49 patients with an excellent clinical response at the end of treatment, symptoms were exacerbated in 18 at the follow-up evaluation. Overall, the draft fourth edition, with some modifications of the third edition criteria, such as the addition of a follow-up evaluation 7 days after the cessation of drug administration, has the potential to play a role in the international standards for evaluating antimicrobial drug efficacy for complicated urinary tract infections. PMID:17982714

  17. A Sequential Phase 2b Trial Design for Evaluating Vaccine Efficacy and Immune Correlates for Multiple HIV Vaccine Regimens

    PubMed Central

    Gilbert, Peter B.; Grove, Douglas; Gabriel, Erin; Huang, Ying; Gray, Glenda; Hammer, Scott M.; Buchbinder, Susan P.; Kublin, James; Corey, Lawrence; Self, Steven G.

    2012-01-01

    Five preventative HIV vaccine efficacy trials have been conducted over the last 12 years, all of which evaluated vaccine efficacy (VE) to prevent HIV infection for a single vaccine regimen versus placebo. Now that one of these trials has supported partial VE of a prime-boost vaccine regimen, there is interest in conducting efficacy trials that simultaneously evaluate multiple prime-boost vaccine regimens against a shared placebo group in the same geographic region, for accelerating the pace of vaccine development. This article proposes such a design, which has main objectives (1) to evaluate VE of each regimen versus placebo against HIV exposures occurring near the time of the immunizations; (2) to evaluate durability of VE for each vaccine regimen showing reliable evidence for positive VE; (3) to expeditiously evaluate the immune correlates of protection if any vaccine regimen shows reliable evidence for positive VE; and (4) to compare VE among the vaccine regimens. The design uses sequential monitoring for the events of vaccine harm, non-efficacy, and high efficacy, selected to weed out poor vaccines as rapidly as possible while guarding against prematurely weeding out a vaccine that does not confer efficacy until most of the immunizations are received. The evaluation of the design shows that testing multiple vaccine regimens is important for providing a well-powered assessment of the correlation of vaccine-induced immune responses with HIV infection, and is critically important for providing a reasonably powered assessment of the value of identified correlates as surrogate endpoints for HIV infection. PMID:23181167

  18. A prospective study to assess the efficacy and safety of oral propranolol as first-line treatment for infantile superficial hemangioma

    PubMed Central

    Yun, Yeong Ju; Gyon, Yun Hee; Yang, Sohyoung; Lee, Youn Kyung; Park, Joohyun

    2015-01-01

    Purpose To determine the efficacy and safety of oral propranolol as a first-line treatment for superficially located infantile hemangioma (IH) and propose an assessment tool to measure treatment response. Methods Patients with superficial IH under 1 year of age were prospectively recruited between May 2012 and December 2013 at the Department of Pediatrics of Chungbuk National University Hospital. Propranolol was administered to 12 infants (median age, 3.8 months) while monitoring cardiovascular and adverse metabolic effects. If a patient showed no adverse events, the dosage was gradually increased up to 3 mg/kg/day and maintained for 1 year. We used our own scoring system to assess treatment response using parameters like change in color, and longest diameter, and thickness of the IH. Results Eleven out of 12 patients completed the protocol with consistent improvement of hemangiomas during therapy. Patients on propranolol showed a more than 50% involution in the first 3 months, with additional steady involution until 1 year. Patients with the highest scores at 1 month maintained their score and showed better responses until treatment termination. The patient with the lowest score at 1 month did not show any further regression and stopped propranolol treatment 4 months after initiation. In two children with recurrences after successful therapeutic regression, propranolol was effective after being reintroduced. Propranolol treatment was not interrupted in any patient due to adverse events. Conclusion Oral propranolol at 3 mg/kg/day showed a consistent, rapid, and therapeutic effect on superficial IHs without significant adverse events. PMID:26770224

  19. Efficacy and safety during formulation switch of a pasteurized VWF/FVIII concentrate: results from an Italian prospective observational study in patients with von Willebrand disease.

    PubMed

    Castaman, G; Coppola, A; Zanon, E; Boeri, E; Musso, M; Siragusa, S; Federici, A B; Mancuso, G; Barillari, G; Biasoli, C; Feola, G; Franchini, M; Moratelli, S; Gamba, G; Schinco, P; Valdrè, L; Dragani, A; Mazzucconi, G; Tagliaferri, A; Morfini, M

    2013-01-01

    Von Willebrand disease (VWD) is an inherited bleeding disorder caused by the quantitative or qualitative deficiency of von Willebrand factor (VWF). Replacement therapy with plasma-derived VWF/factor VIII (FVIII) concentrates is required in patients unresponsive to desmopressin. To assess the efficacy, safety and ease of use of a new, volume-reduced (VR) formulation of VWF/FVIII concentrate Haemate(®) P in patients requiring treatment for bleeding or prophylaxis for recurrent bleeding or for invasive procedures. Pharmacoeconomic variables were also recorded. Data were analysed using descriptive statistics. This was a multicentre, prospective, observational study. Consecutively enrolled patients received Haemate(®) P VR according to their needs, and were followed for 24 months. Of the 121 patients enrolled, 25.6% had type 3 VWD and more than 40% had severe disease. All patients were followed for 2 years, for a total of 521 visits. On-demand treatment was given to 61.9% of patients, secondary long-term prophylaxis to 25.6% and prophylaxis for surgery, dental or invasive procedures to 45.5%. The response to treatment was rated as good to excellent in >93-99% of interventions. The new formulation was well tolerated by all patients with no report of drug-related adverse events. The switch to volume-reduced Haemate(®) P was easy to perform and infusion duration was decreased twofold compared with the previous formulation. Volume-reduced Haemate(®) P was at least as effective and well-tolerated as the previous formulation. PMID:22957493

  20. Development and Evaluation of Mouth Dissolving Films of Amlodipine Besylate for Enhanced Therapeutic Efficacy.

    PubMed

    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

  1. 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

  2. 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

  3. Technology efficacy in active prosthetic knees for transfemoral amputees: a quantitative evaluation.

    PubMed

    El-Sayed, Amr M; Hamzaid, Nur Azah; 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

  4. 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

  5. Evaluating the efficacy of a mental models approach for improving occupational chemical risk protection.

    PubMed

    Niewöhner, Jörg; Cox, Patrick; Gerrard, Simon; Pidgeon, Nick

    2004-04-01

    Chemical risk protection in the workplace relies partly on informing workers about possible risks using material safety data sheets (MSDS). This article reports on phase 2 of a project (phase 1 reported in Cox et al.), which employed a mental models approach to improve on data sheets as communicative interventions for perchloroethylene in dry cleaning and rosin-based solder flux in the electronics industry within small businesses in the United Kingdom (small enterprises (SEs) < 25 employees in the workplace). It focuses on the efficacy of a multimethod evaluation strategy to assess (1) the capacity of a mental models approach to yield contextually relevant data for intervention design and (2) the effectiveness of the strategy itself in validating the mental models data. The evaluation was conducted using postal questionnaires and semi-structured verbal protocols to provide responses to the alternative intervention content and to prioritize risk messages. User discussion groups were then employed, particularly as a means of establishing whether contextual information could be obtained that would differ qualitatively from the kind elicited through individual (semi) structured methods. We conclude that the mental models approach as part of an iterative process including systematic multimethod evaluation is successful in supporting the design of relevant communications to the users of chemicals. The overall viability of communicative interventions in the context of health and safety in small businesses remains in question. Future research might aim to develop a more holistic approach to interventions in complex occupational contexts. PMID:15078306

  6. Teachers' Source Evaluation Self-Efficacy Predicts Their Use of Relevant Source Features When Evaluating the Trustworthiness of Web Sources on Special Education

    ERIC Educational Resources Information Center

    Andreassen, Rune; Bråten, Ivar

    2013-01-01

    Building on prior research and theory concerning source evaluation and the role of self-efficacy in the context of online learning, this study investigated the relationship between teachers' beliefs about their capability to evaluate the trustworthiness of sources and their reliance on relevant source features when judging the trustworthiness…

  7. In-hospital resuscitation evaluated by in situ simulation: a prospective simulation study

    PubMed Central

    2011-01-01

    Background Interruption in chest compressions during cardiopulmonary resuscitation can be characterized as no flow ratio (NFR) and the importance of minimizing these pauses in chest compression has been highlighted recently. Further, documentation of resuscitation performance has been reported to be insufficient and there is a lack of identification of important issues where future efforts might be beneficial. By implementing in situ simulation we created a model to evaluate resuscitation performance. The aims of the study were to evaluate the feasibility of the applied method, and to examine differences in the resuscitation performance between the first responders and the cardiac arrest team. Methods A prospective observational study of 16 unannounced simulated cardiopulmonary arrest scenarios was conducted. The participants of the study involved all health care personel on duty who responded to a cardiac arrest. We measured NFR and time to detection of initial rhythm on defibrillator and performed a comparison between the first responders and the cardiac arrest team. Results Data from 13 out of 16 simulations was used to evaluate the ability of generating resuscitation performance data in simulated cardiac arrest. The defibrillator arrived after median 214 seconds (180-254) and detected initial rhythm after median 311 seconds (283-349). A significant difference in no flow ratio (NFR) was observed between the first responders, median NFR 38% (32-46), and the resuscitation teams, median NFR 25% (19-29), p < 0.001. The difference was significant even after adjusting for pulse and rhythm check and shock delivery. Conclusion The main finding of this study was a significant difference between the first responders and the cardiac arrest team with the latter performing more adequate cardiopulmonary resuscitation with regards to NFR. Future research should focus on the educational potential for in-situ simulation in terms of improving skills of hospital staff and patient

  8. The self-tapping and ICE 3i implants: a prospective 3-year multicenter evaluation.

    PubMed

    Davarpanah, M; Martinez, H; Tecucianu, J F; Alcoforado, G; Etienne, D; Celletti, R

    2001-01-01

    This multicenter prospective clinical evaluation was undertaken to determine the therapeutic success and marginal bone level stability of 3i's self-tapping and ICE implants after 3 years of prosthetic loading. Between July 1995 and June 1996, 189 completely or partially edentulous patients were treated with 614 machined-surface screw-type commercially pure titanium implants (self-tapping or ICE). Two hundred seventy-seven self-tapping implants were placed in 85 patients (average age of 56 years), and 337 ICE implants were placed in 104 patients (average age of 61 years). A total of 360 implants (58.6%) were placed in posterior segments. Easier placement was reported with the ICE implant in normal or dense bone. For the self-tapping implants, survival rates of 92.9% and 91.6% were noted after 1 and 3 years of prosthetic loading, respectively. Survival rates of 95.4% and 93.8% were obtained with the ICE implant for the same periods. Late failures (after loading) were more common than early failures (before loading) for both types of implants. The marginal bone level of 238 self-tapping implants (85.9%) and of 307 ICE implants (91%) was radiographically evaluated at 3 years. Marginal bone level was at the first thread for 95.1% of implants. A loss of marginal bone level of 2 to 4 threads was noted for 4.9% of the evaluated implants. No implant showed bone loss greater than the fourth thread. Overall survival rates of 94.3% and 92.9% were obtained after 1 and 3 years of prosthetic loading, respectively, for 596 and 588 implants. PMID:11280362

  9. The Evaluation of Community Service-Learning Course in Terms of Prospective Teachers' and Instructors' Opinions

    ERIC Educational Resources Information Center

    Kesten, Alper

    2012-01-01

    In this study, development of THU in the world and in Turkey was briefly mentioned and THU was assessed with respect to the views of prospective teachers and instructors about this course, which has been launched in Turkey in the 2008-2009 academic year. The sample in this study consists of five prospective teachers who are students of the College…

  10. Evaluation of the Patriotic Attitudes of the Prospective Teachers According to Various Variables

    ERIC Educational Resources Information Center

    Tonga, Deniz; Aksoy, Bulent

    2014-01-01

    This study deals with the investigation of the patriotic attitudes of the prospective teachers seeking the answer of the question "what are the levels of the patriotic attitudes of the prospective teachers?" For this purpose a descriptive survey model of patriotism scale developed by Schatz, Staub and Lavine and adapted to Turkish by…

  11. Method for evaluation of the efficacy of antimicrobial preservatives in cosmetic wet wipes.

    PubMed

    Crémieux, A; Cupferman, S; Lens, C

    2005-08-01

    Many cosmetic formulations are now available in the form of wet wipes packaged in sealed sachets or packets. Like the majority of cosmetic products having an aqueous phase, wipes are susceptible to microbial contamination and require the addition of preservatives. The efficacy of such preservatives can be evaluated using a standard challenge test performed on the wetting liquid but this test cannot be regarded as representative for this new type of formulation. The method presented here evaluates the efficacy of preservatives used in wet wipes kept in their original packaging. Dried inoculums were prepared by membrane filtration followed by drying in an incubator. The method is applicable to bacteria (Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus and Enterococcus faecalis), Bacillus cereus spores and fungi (Candida albicans and Aspergillus niger). These inoculated carriers were inserted between two wipes in the original package, which was then re-sealed immediately. The test requires one dry inoculum per packet and one packet for each control or test. After incubation at 22.5 degrees C for 1, 2, 7, 14 or 28 days and, for the control, immediately after insertion of the membrane (time 0), microorganism counts were performed on the germ-carrier membranes as well as on adjacent wipes, after transfer into a suitable neutralizing agent. The membranes were shaken in the presence of glass beads and microorganisms were dissociated from the wipes by means of a Stomacher. The supernatants recovered after being left to stand for 20 min are counted by pour plate method or membrane filtration. The feasibility of the method was demonstrated for each of the seven above-mentioned strains. The repeatability and reproducibility of the results obtained is similar to that obtained for preservative efficacy tests in the Pharmacopoeias. The lethal rate of microorganisms during the preparation of dry inoculums ranges from 50 to 90% depending on the strain and the test

  12. 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…

  13. Evaluation of tocolytic efficacy of selective beta2 adrenoceptor agonists on buffalo uterus.

    PubMed

    Garg, Satish K; Garg, K M; Sabir, M

    2004-09-01

    Present study was conducted on prostaglandin F2alpha (PGF2alpha), oxytocin, (OT), potassium chloride (KCI) and barium chloride (BaCl2) pre-contracted perimetrial uterine strips of dioestrus and pregnant buffaloes to evaluate the tocolytic efficacy of selective beta2 adrenoceptor agonists-albuterol (salbutamol) and terbutaline. Cumulative concentration-response curves of both the beta2 adrenoceptor agonists were constructed and the mean effective concentration (EC50) values determined and compared statistically. Based on the comparative EC50 values in relaxing the pre-contracted uterine strips with different spasmogens, the rank order potency of albuterol was found to be--PGF2alpha > BaCl2 > OT > KCl on uterine strips from dioestrus animals, while OT> BaCl2> PGF2alpha >KCl on the uterine strips of pregnant buffaloes. The rank order potency of terbutaline on uterine strips from dioestrus stage animals was- BaCl2 > OT > KCl > PGF2alpha, while BaCl2 > PGF2alpha > KCl > OT on uterine tissues of pregnant animals. Thus, irrespective of the state of uterus, whether gravid or non-gravid, KCl-depolarized uterine tissues required comparatively higher concentrations of albuterol or terbutaline to produce tocolytic effect. High concentrations of K+ in biophase may have interfered with the beta2 adrenoceptor agonists-induced outward K+ current and hyperpolarization. From the results of present study, it was evident that selective beta2 adrenergic agonists had good tocolytic efficacy on the uterus of buffaloes. Further, indirectly the possibility of existence and activation of K(Ca) channels by selective beta2 adrenoceptor agonists in mediating tocolysis of buffalo myometrium can not be ruled out, however, detailed studies using specific K(Ca) channel blockers are required for characterizing the nature of such channels in buffalo uterus. PMID:15462186

  14. Potential medications for the treatment of alcohol use disorder: An evaluation of clinical efficacy and safety.

    PubMed

    Litten, Raye Z; Wilford, Bonnie B; Falk, Daniel E; Ryan, Megan L; Fertig, Joanne B

    2016-01-01

    Alcohol use disorder (AUD), as currently defined in the Diagnostic and Statistical Manual, 5th Edition (DSM-5), is a heterogeneous disorder stemming from a complex interaction of neurobiological, genetic, and environmental factors. As a result of this heterogeneity, there is no one treatment for AUD that will work for everyone. During the past 2 decades, efforts have been made to develop a menu of medications to give patients and clinicians more choices when seeking a therapy that is both effective and which has limited side effects. To date, 3 medications have been approved by the US Food and Drug Administration (FDA) to treat alcohol dependence: disulfiram, naltrexone, and acamprosate. In addition to these approved medications, researchers have identified new therapeutic targets and, as a result, a number of alternative medications are now being evaluated for treatment of AUD in human studies. Although not approved by the FDA for the treatment of AUD, in some cases, these alternative medications are being used off-label by clinicians for this purpose. These potential medications are reviewed here. They include nalmefene, varenicline, gabapentin, topiramate, zonisamide, baclofen, ondansetron, levetiracetam, quetiapine, aripiprazole, and serotonin reuptake inhibitors. The effectiveness of these medications has been mixed-some show good efficacy with side effects that are mild to moderate in intensity; others have mixed or promising results but are awaiting findings from ongoing studies; and still others show poor efficacy, despite promising preliminary results. Medications development remains a high priority. Key initiatives for the National Institute on Alcohol Abuse and Alcoholism (NIAAA) include supporting the discovery and development of more effective and safer medications, advancing the field of personalized medicine, and forging public and private partnerships to investigate new and more effective compounds. PMID:26928397

  15. Discovery and preclinical antitumor efficacy evaluations of LY32262 and LY33169.

    PubMed

    Corbett, Thomas H; White, Kathryn; Polin, Lisa; Kushner, Juiwanna; Paluch, Jennifer; Shih, Chuan; Grossman, Cora Sue

    2003-02-01

    The discoveries of a new antitumor agent (LY32262) (N-[2,4-dichlorobenzoyl]phenylsulfonamide) and a close analog (LY33169) are described. For this discovery, a disk-diffusion-soft-agar-colony-formation-assay was used to screen a portion of the Eli Lilly inventory, with the evaluation of each agent against normal cells, leukemic cells and several solid tumors, including a multidrug-resistant solid tumor (with marked selective cytotoxicity for Colon-38 and Human-Colon-15/MDR compared to normal fibroblasts and L1210 leukemic cells characterizing the discovery). In mice, LY32262 and/or LY33169 had curative activity against Colon Adenocarcinoma-38, Human Colon-116, Human Prostate LNCaP, and Human Breast WSU-Br-1. In addition, many other tumors were highly sensitive: Panc-03 = 2.4 log kill (LK); Panc-02 = 2.9-4.1 LK; Squamous Lung LC-12 = 2.1 LK; Colon-26 = 2.2 LK; AML1498 = 2.7 LK; Human Sm Cell Lung DMS-273 = 6.3 LK; Human Squamous Lung 165 = 3.7 LK; Human Ovarian BG-1 = 3.7 LK; Human Colon CX-1 (H29) = 1.6 LK; Human Colon-15/MDR (a p-glycoprotein positive multidrug resistant tumor) = 2.3 LK; Human CNS-gliosarcoma-SF295 = 3.8 LK. Several tumors were only marginally responsive or totally unresponsive: Mammary Adenocarcinoma-16/C = 0.6 LK; Mammary Adenocarcinoma-17 = no kill; Colon Adenocarcinoma-11 = no kill; L1210 leukemia = 1.3 LK; Human Prostate PC-3 = 0.5 LK; Human Adenosquamous Lung H125 = no kill; and Human Breast Adenocarcinoma MX-1 = 0.9 LK. There was no absolute tissue of origin correlation with antitumor efficacy, although colon tumors were most responsive and mammary tumors least responsive. The cause of the "hit and miss" efficacy has not been determined. PMID:12795528

  16. Evaluation of efficacy and safety of conjugated estrogens/bazedoxifene in a Latin American population.

    PubMed

    Palacios, S; Arias, L; Lavenberg, J; Pan, K; Mirkin, S; Komm, B S

    2016-06-01

    Introduction Conjugated estrogens/bazedoxifene (CE/BZA) relieves menopausal symptoms and increases bone mineral density (BMD). Objective To evaluate CE/BZA in a Latin American subpopulation from randomized, double-blind, phase-3, multinational trials. Methods Safety data were pooled from three trials from non-hysterectomized postmenopausal Latin American women assigned to CE 0.45 mg/BZA 20 mg (n = 227), CE 0.625 mg/BZA 20 mg (n = 222), or placebo (n = 193). Efficacy outcomes from one study included changes in hot flush frequency at week 12 in women with at least seven moderate/severe hot flushes/day or 50/week at baseline (n = 39), and from baseline to month 12 for BMD (n = 381) and genitourinary syndrome of menopause (GSM) (women with baseline GSM; n = 189). Results At week 12, women taking CE/BZA had four to five fewer moderate/severe hot flushes/day vs. placebo. At month 12, percentage changes in BMD with CE 0.45 mg/BZA 20 mg, CE 0.625 mg/BZA 20 mg, and placebo were 1.2%, 1.6%, and -1.1% for lumbar spine and 1.1%, 1.2%, and -0.3% for total hip. GSM improved with treatment (percentage superficial cells: 4.5, 7.4, vs. 2.0; percentage parabasal cells: -9.3, -27.8 vs. 2.8). There were no new/unexpected safety trends. Conclusion CE/BZA improved vasomotor symptoms, GSM, and BMD in Latin American women, with efficacy/safety similar to the global population. PMID:26940720

  17. Synthesis, characterization, and in vivo efficacy evaluation of PGG–docetaxel conjugate for potential cancer chemotherapy

    PubMed Central

    Yang, Danbo; Van, Sang; Shu, Yingyi; Liu, Xiaoqing; Ge, Yangfeng; Jiang, Xinguo; Jin, Yi; Yu, Lei

    2012-01-01

    Aim This work is intended to develop and evaluate a biopolymeric poly(L-γ-glutamylglutamine) (PGG)–docetaxel (DTX) conjugate that can spontaneously self-assemble in aqueous solutions to become nanoparticles. Methods DTX was covalently attached to hydrophilic PGG by direct esterification, and the conjugate was characterized by proton nuclear magnetic resonance spectroscopy, molecular weight gel permeation chromatography, solubility, size distribution and morphology, and hemolysis. Conjugated DTX was found to have 2000 times improved water solubility compared with free DTX. Dynamic light scattering, transmission electron microscopy, and atomic force microscopy revealed the particle size, distribution and morphology of the PGG–DTX conjugate. In addition, the conjugate was further tested for in vitro cytotoxicity and in vivo antitumor efficacy on the human non-small cell lung cancer cell line NCI-H460. Results Conjugated DTX was found to have 2000 times improved water solubility compared with free DTX. The conjugate formed nanoparticles with an average diameter of 30 nm in spherical shape and unimodal particle size distribution. The conjugate exhibited about 2% hemolysis at 10 mg/mL, compared with 56% for Tween 80® at 0.4 mg/mL, and 33% for Cremophor EL® at 10 mg/mL. In addition, the conjugate was further tested for in vitro cytotoxicity and in vivo antitumor efficacy on the human non-small cell lung cancer cell line NCI-H460. As expected, conjugated DTX exhibited lower cytotoxicity compared to that of free DTX, in concentration-dependent manner. However, PGG–DTX showed better antitumor activity in NCI-H460 lung cancer-bearing mice with minimal weight loss compared to that of free DTX. Conclusion The PGG–DTX conjugate may be considered as an attractive and promising polymeric DTX conjugate for non-small cell lung cancer treatment. PMID:22334784

  18. Effects of contraceptive method on the vaginal microbial flora: a prospective evaluation.

    PubMed

    Gupta, K; Hillier, S L; Hooton, T M; Roberts, P L; Stamm, W E

    2000-02-01

    A prospective evaluation of 331 university women who were initiating use of oral contraceptive pills (OCPs), a cervical cap, diaphragm-spermicide, or other spermicidal methods was done to assess the effects of commonly used contraceptive methods on the vaginal flora. Vaginal introital cultures were performed at baseline and then weekly for 1 month. The prevalence of Escherichia coli vaginal colonization and of abnormal vaginal Gram stain scores (Nugent criteria) increased significantly among women using a cervical cap or diaphragm-spermicide but not among women using OCPs. Women with E. coli colonization were significantly more likely to have an abnormal Nugent score and an absence of lactobacilli. In a multivariate model, use of spermicidal contraception in the preceding week was associated with an abnormal Nugent score and with colonization with E. coli, Enterococcus species, and anaerobic gram-negative rods. Thus, spermicidal methods of contraception are associated with alterations of the vaginal microflora that consequently may predispose women to genitourinary infections. PMID:10669343

  19. Evaluating outcomes of the child and adolescent psychiatric unit: A prospective study

    PubMed Central

    2011-01-01

    Background The aims of this prospective study are to clarify the outcomes of child psychiatric inpatient treatment and to identify factors associated with patient improvement. Methods The attending psychiatrist used the Children's Global Assessment Scale (CGAS) to assess youths at admission to and discharge from a child and adolescent psychiatric unit in Japan(N = 126, mean age = 12.8, SD = 1.9). Hospital records gathered sociodemographic and clinical variables. In addition, youths and their primary caregivers assessed themselves using the Youth Self Report (YSR) and the Child Behavior Checklist (CBCL), respectively. Longitudinal analyses compared each scales' baseline and discharge scores. We also examined factors associated with changes in functioning (CGAS). Results Longitudinal comparisons revealed that CGAS, CBCL and YSR scores showed improvement over time (CGAS: t = -14.40, p = 0.00; CBCL: t = 3.80, p = 0.00; YSR: t = 2.40, p = 0.02). Linear regressions determined that the factors associated with improvement in CGAS included age, lower CGAS scores at admission, frequency of group therapy and psychiatric diagnosis. Conclusions This evaluation of children and adolescents in an inpatient unit demonstrated clinical improvement over time and identified factors associated with said improvement. PMID:21453481

  20. Temporary abdominal closure: a prospective evaluation of its effects on renal and respiratory physiology.

    PubMed

    Sugrue, M; Jones, F; Janjua, K J; Deane, S A; Bristow, P; Hillman, K

    1998-11-01

    This study prospectively analyzed outcomes in 49 consecutive patients undergoing temporary abdominal closure (TAC) between 1993 and 1996 at a single university hospital. There were 37 males and 12 females, mean age was 57 years (range, 25-79 years), mean Acute Physiology and Chronic Health Evaluation score was 27 (+7.8 SD), and mean Simplified Acute Physiology II score was 53.0 (+/-15.4). The reason for TAC was decompression in 22 patients, inability to close the abdomen in 10 patients, to facilitate reexploration for sepsis in 8 patients, and multifactorial in 9 patients. After TAC, there was a significant reduction in intra-abdominal pressure from 24.2+/-9.3 to 14.1+/-5.5 mm Hg and improvement in lung dynamic compliance from 24.1+/-7.9 to 27.6+/-9.4 mL/cm H2O (p < 0.05). Although 10 patients experienced brisk diuresis, there was no significant improvement in renal function; in fact, serum creatinine increased. The median length of stay was 35 days (range, 1-232 days). The mean number of abdominal operations after mesh insertion was 2.6+/-2.4. There were 21 deaths, for a standardized mortality rate of 0.80. Although it achieved significant reductions in abdominal pressures and improved lung dynamic compliance, TAC did not result in improved renal function or patient oxygenation. PMID:9820703

  1. Prospective evaluation of radionuclide scanning in detection of intestinal necrosis in neonatal necrotizing enterocolitis.

    PubMed

    Haase, G M; Sfakianakis, G N; Lobe, T E; Boles, E T

    1981-06-01

    The ability of external imaging to demonstrate intestinal infarction in neonatal necrotizing enterocolitis (NEC) was prospectively evaluated. The radiopharmaceutical technetium--99m diphosphonate was injected intravenously and the patients subsequently underwent abdominal scanning. Clinical patient care and interpretation of the images were entirely independent throughout the study. Of 33 studies, 7 were positive, 4 were suspicious, and 22 were negative. One false positive study detected ischemia without transmural infarction. The second false positive scan occurred postoperatively and was due to misinterpretation of the hyperactivity along the surgical incision. None of the suspicious cases had damaged bowel. The two false negative studies clearly failed to demonstrate frank intestinal necrosis. The presence of very small areas of infarction, errors in technical settings, subjective interpretation of scans and delayed clearance of the radionuclide in a critically ill neonate may all limit the accuracy of external abdominal scanning. However, in spite of an error rate of 12%, it is likely that this technique will enhance the present clinical, laboratory, and radiologic parameters of patient management in NEC. PMID:7019410

  2. Evaluation of 1/f noise in prospective IR imaging thin films

    NASA Astrophysics Data System (ADS)

    Basantani, Hitesh A.; Saint John, David B.; Podraza, Nikolas J.; Jackson, Thomas N.; Horn, Mark W.

    2014-06-01

    Vanadium oxide (VOx) and hydrogenated silicon germanium (SixGe1-x) are the two predominant thin film material systems used as the active layer in resistive infrared imaging. Thin films of VOx used in microbolometers have a resistivity typically between 0.1 and 1 Ω-cm with a temperature coefficient of resistance, |TCR| between 1.4%/K to 2.4%/K, while SixGe1-x:H thin films have a resistivity between 200-4,000 Ω-cm with a |TCR| between 2.9%/K to 3.9%/K. Future devices may require higher TCR materials, however, higher TCR is loosely associated with higher resistivity and therefore also with high noise. This work compares 1/f noise of high resistivity VOx and Ge:H thin films having |TCR| < 3.6%/K. The high TCR thin films of VOx were found to be amorphous while, depending on the deposition conditions, the Ge:H thin films were either amorphous or mixed phase of amorphous + nanocrystalline. Evaluation of these VOx and Ge:H thin films indicates a prospects for a superior process-property relation of 1/f noise in Ge:H thin films in comparison with thin films of VOx.

  3. An integrated approach to evaluate gas hydrate prospects in SW Barents Sea

    NASA Astrophysics Data System (ADS)

    Chand, Shyam; Knies, Jochen; Jensen, Henning; Baranwal, Soma; Klug, Martin

    2014-05-01

    The SW Barents Sea subsurface has undergone large changes in geomorphology due to the impact of glaciations on its surface and subsurface. Glacial erosion during Plio-Pleistocene removed large thickness of sediments from the seabed and opened up the faults causing basin wide spillage of hydrocarbon fluids. Pockmarks are widely distributed in the SW Barents Sea. Regional fault complexes such as the Ringvassøy Loppa Fault Complex are reported to be open pathways for fluids with the observation of large acoustic gas flares in the water column. We analysed selected gravity cores from Veslemøy high based on subsurface seismic amplitude anomalies and structural controls of fluid flow towards the seafloor. The subsurface fluid flow at Veslemøy high is observed to be controlled by the evolution history of the region. This includes 1) the morphology and orientation of regional faults, structural highs and basins, 2) the presence of lithological boundaries linked to the palaeo morphology of the region, 3) glacial and post glacial sediment thickness. Estimates of extractable organic matter and foraminifera influenced by microseeps at different levels of the post glacial sediments are related to fluid flow governed by the subsurface architecture of the sedimentary units. The fluid flow model is compared to other provinces of Barents Sea to evaluate the gas hydrate prospects of SW Barents Sea.

  4. Evaluation of WHO criteria for diagnosis of polycythemia vera: a prospective analysis.

    PubMed

    Silver, Richard T; Chow, William; Orazi, Attilio; Arles, Stephen P; Goldsmith, Stanley J

    2013-09-12

    We prospectively evaluated the accuracy of the 2007 World Health Organization (WHO) criteria for diagnosing polycythemia vera (PV), especially in "early-stage" patients. A total of 28 of 30 patients were diagnosed as PV owing to an elevated Cr-51 red cell mass (RCM), JAK2 positivity, and at least 1 minor criterion. A total of 18 PV patients did not meet the WHO criterion for an increased hemoglobin value and 8 did not meet the WHO criterion for an increased hematocrit value. Bone marrow morphology was very valuable for diagnosis. Low serum erythropoietin (EPO) values were specific for PV, but normal EPO values were found at presentation (20%). We recommend revision of the WHO criteria, especially to distinguish early-stage PV from essential thrombocythemia. Major criteria remain JAK2 positivity and increased red cell volume, but Cr-51 RCM is mandatory for patients who do not meet the defined elevated hemoglobin or hematocrit value (>18.5 g/dL and 60% in men and >16.5 g/dL and 56% in women, respectively). Minor criteria remain bone marrow histology or a low serum EPO value. For patients with a normal EPO value, marrow examination is mandatory for diagnostic confirmation. Because the therapies for myeloproliferative disorders differ, our data have major clinical implications. PMID:23900239

  5. The Utility of Blood Culture Fluid for the Molecular Diagnosis of Leptospira: A Prospective Evaluation

    PubMed Central

    Dittrich, Sabine; Rudgard, William E.; Woods, Kate L.; Silisouk, Joy; Phuklia, Weerawat; Davong, Viengmon; Vongsouvath, Manivanh; Phommasone, Koukeo; Rattanavong, Sayaphet; Knappik, Michael; Craig, Scott B.; Weier, Steven L.; Tulsiani, Suhella M.; Dance, David A. B.; Newton, Paul N.

    2016-01-01

    Leptospirosis is an important zoonosis worldwide, with infections occurring after exposure to contaminated water. Despite being a global problem, laboratory diagnosis remains difficult with culture results taking up to 3 months, serology being retrospective by nature, and polymerase chain reaction showing limited sensitivity. Leptospira have been shown to survive and multiply in blood culture media, and we hypothesized that extracting DNA from incubated blood culture fluid (BCF), followed by quantitative real-time polymerase chain reaction (qPCR) could improve the accuracy and speed of leptospira diagnosis. We assessed this retrospectively, using preincubated BCF of Leptospira spp. positive (N = 109) and negative (N = 63) febrile patients in Vientiane, Lao PDR. The final method showed promising sensitivities of 66% (95% confidence interval [CI]: 55–76) and 59% (95% CI: 49–68) compared with direct or direct and indirect testing combined, as the respective reference standards (specificities > 95%). Despite these promising diagnostic parameters, a subsequent prospective evaluation in a Lao hospital population (N = 352) showed that the sensitivity was very low (∼30%) compared with qPCR on venous blood samples. The disappointingly low sensitivity does suggest that venous blood samples are preferable for the clinical microbiology laboratory, although BCF might be an alternative if leptospirosis is only suspected postadmission after antibiotics have been used. PMID:26880775

  6. The Utility of Blood Culture Fluid for the Molecular Diagnosis of Leptospira: A Prospective Evaluation.

    PubMed

    Dittrich, Sabine; Rudgard, William E; Woods, Kate L; Silisouk, Joy; Phuklia, Weerawat; Davong, Viengmon; Vongsouvath, Manivanh; Phommasone, Koukeo; Rattanavong, Sayaphet; Knappik, Michael; Craig, Scott B; Weier, Steven L; Tulsiani, Suhella M; Dance, David A B; Newton, Paul N

    2016-04-01

    Leptospirosis is an important zoonosis worldwide, with infections occurring after exposure to contaminated water. Despite being a global problem, laboratory diagnosis remains difficult with culture results taking up to 3 months, serology being retrospective by nature, and polymerase chain reaction showing limited sensitivity. Leptospira have been shown to survive and multiply in blood culture media, and we hypothesized that extracting DNA from incubated blood culture fluid (BCF), followed by quantitative real-time polymerase chain reaction (qPCR) could improve the accuracy and speed of leptospira diagnosis. We assessed this retrospectively, using preincubated BCF of Leptospira spp. positive (N= 109) and negative (N= 63) febrile patients in Vientiane, Lao PDR. The final method showed promising sensitivities of 66% (95% confidence interval [CI]: 55-76) and 59% (95% CI: 49-68) compared with direct or direct and indirect testing combined, as the respective reference standards (specificities > 95%). Despite these promising diagnostic parameters, a subsequent prospective evaluation in a Lao hospital population (N= 352) showed that the sensitivity was very low (∼30%) compared with qPCR on venous blood samples. The disappointingly low sensitivity does suggest that venous blood samples are preferable for the clinical microbiology laboratory, although BCF might be an alternative if leptospirosis is only suspected postadmission after antibiotics have been used. PMID:26880775

  7. Prospective Evaluation of Cases of Discharge against Medical Advice in Abuja, Nigeria

    PubMed Central

    Anthonia, Obalim-Chris; Chinwe, Igwilo; Oluwafemi, Adewumi; Ganiyu, Aremu; Haroun, Adamu; Chinwe, Eziechila; Joshua, Aiyekomogbon

    2015-01-01

    Background. Discharge against medical advice (DAMA) is a global clinical phenomenon contributing significantly to adverse patients' outcome. Literatures abound on self-discharges in specific medical subpopulations. However, multidisciplinary studies on this subject in our region are few. Aim. To prospectively evaluate cases of DAMA in a wholesale multidisciplinary perspective at Federal Staff Medical Centre, Abuja, and suggest strategies to reduce it. Patients and Methods. All consecutive patients who DAMA from our medical centre between June 2013 and May 2014 were included in the study. Data harvested from the standard proforma were analyzed using IBM SPSS version 19.0. Results. We recorded an overall DAMA rate of 2.1%. The majority of the patients were paediatric cases (n = 63, 44.6%) while closed long bone fractures represented the leading diagnosis (n = 35, 24.8%). The most commonly cited reasons for leaving the hospital were financial constraints (n = 46, 32.6%) and seeking alternative therapy (n = 25, 17.7%). Conclusion. The DAMA rate in our study is comparable to some urban hospitals elsewhere. However, the leading reasons for this phenomenon are unacceptable in the current medical best practice. Thus, strengthening the Health Insurance Scheme, strict control of traditional medical practices, and focused health education are recommended strategies to reduce DAMA. PMID:25821850

  8. Efficacy and Safety Evaluation on Arterial Thrombolysis in Treating Acute Cerebral Infarction.

    PubMed

    Shen, Baozhong; Liu, Qingan; Gu, Yingli; Wang, Yan; Zhang, Zhuobo

    2015-11-01

    The objective of this study was to evaluate the efficacy and safety of intra-arterial thrombolysis in treating acute cerebral infarction and further discuss the indications of acute cerebral infarction treatment, in order to enhance the therapeutic effects of arterial thrombolysis. The data of 164 patients with acute cerebral infarction who accepted intra-arterial thrombolysis treatment by using rt-PA or reteplase between 2009 and 2014 at the Department of Neurology of our hospital, were collected, including patients' medical history, characteristics of the onset procedure, intervals between onset and intra-arterial thrombolysis, bleeding or death, and the changing process of patient's main neurologic function after the treatment. The neurological functions including muscle strength, speech, and level of consciousness were chosen for evaluation. Through a review of cerebral angiography, we collected the digital subtraction angiography (DSA) morphological changes of blood vessels before and after arterial thrombolysis to evaluate whether those blood vessels had been reperfused. Thereafter, we analyzed and statistically processed above-mentioned data. The mean time of arterial thrombolysis was 5.7 h. DSA results were as follows: 22 patients had complete internal carotid artery (ICA) occlusion; 49 patients middle cerebral artery's (MCA's) Ml or M2 segment occlusion; 6 patients anterior cerebral artery (ACA) occlusion; 58 patients reperfusion after thrombolysis, and the recanalization rate was 76 %. Based on vertebral-basilar artery (VBA) system, 18 patients had complete occlusion, 11 patients had reperfusion after thrombolysis, and the recanalization rate was 61 %. A total of 63 patients had severe stenosis, and they had significantly improved after thrombolysis. The clinical symptoms of patients were improved: 79 out of 164 patients with paralysis had partially recovered their limb muscle strength after operation, while 33 patients had completely recovered, and

  9. 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

  10. 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.

  11. Two bacterial infection models in tree shrew for evaluating the efficacy of antimicrobial agents.

    PubMed

    Li, Sheng-An; Lee, Wen-Hui; Zhang, Yun

    2012-02-01

    Animal models are essential for the development of new anti-infectious drugs. Although some bacterial infection models have been established in rodents, small primate models are rare. Here, we report on two bacterial infection models established in tree shrew (Tupaia belangeri chinensis). A burnt skin infection model was induced by dropping 5×10(6) CFU of Staphylococcus aureus on the surface of a wound after a third degree burn. This dose of S. aureus caused persistent infection for 7 days and obvious inflammatory response was observed 4 days after inoculation. A Dacron graft infection model, 2×10(6) CFU of Pseudomonas aeruginosa also caused persistent infection for 6 days, with large amounts of pus observed 3 days after inoculation. These models were used to evaluate the efficacy of levofloxacin (LEV) and cefoperazone (CPZ), which reduced the viable bacteria in skin to 4log10 and 5log10 CFU/100 mg tissue, respectively. The number of bacteria in graft was significantly reduced by 4log10 CFU/mL treatment compared to the untreated group (P<0.05). These results suggest that two bacterial infection models were successfully established in tree shrew using P. aeruginosa and S. aureus. In addition, tree shrew was susceptible to P. aeruginosa and S. aureus, thus making it an ideal bacterial infection animal model for the evaluation of new antimicrobials. PMID:22345001

  12. Evaluation of the In Vitro Efficacy of Sevelamer Hydrochloride and Sevelamer Carbonate.

    PubMed

    Yang, Yongsheng; Mohammad, Adil; Berendt, Robert T; Carlin, Alan; Khan, Mansoor A; Faustino, Patrick J

    2016-02-01

    The objective of this project is to develop an in vitro approach that can be used to determine the phosphate binding capacity of sevelamer hydrochloride and carbonate for both drug products and active pharmaceutical ingredients (APIs). A simple and efficient inductively coupled plasma spectrometer method for analysis of phosphate at physiologically relevant pH conditions has been developed and validated. The method addresses each of the analytical validation characteristics such as linearity, accuracy, precision, stability, and selectivity, and meets the acceptance criteria defined in the United States Food and Drug Administration guidance (Food and Drug Administration, Center for Drug Evaluation and Research. 2001. Guidance for industry-Bioanalytical method validation, May). The in vitro phosphate binding efficacies were systematically evaluated and compared for two drug products and two APIs. The phosphate binding profiles appeared similar between the drug products. Under all conditions, the sevelamer-phosphate binding reached equilibrium at 6 h. The 90% confidence interval for the k2 ratio (sevelamer carbonate vs. sevelamer hydrochloride) was well within 80%-125% under all pH conditions. However, the k1 ratio varied, indicating that there exists difference in the binding affinity. Our findings will be useful in assisting with "in vivo" biowaiver for the approval of generic sevelamer drug products. PMID:26219932

  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 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. PMID:26708799

  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. PMID:24396837

  16. Performance evaluation of a new rapid urine test for chlamydia in men: prospective cohort study

    PubMed Central

    Nadala, Elpidio-Cesar; Goh, Beng T; Magbanua, Jose-Paolo; Barber, Penelope; Swain, Alison; Alexander, Sarah; Laitila, Vivian; Michel, Claude-Edouard; Mahilum-Tapay, Lourdes; Ushiro-Lumb, Ines; Ison, Catherine

    2009-01-01

    Objective To evaluate the performance of a rapid test for chlamydia with first void male urine samples as a potential tool for diagnosis and screening of chlamydial infection in men. Design Evaluation of test performance in prospective cohort study. Settings A young people’s sexual health centre (site 1) and a genitourinary medicine clinic (site 2) in the United Kingdom. Participants 1211 men aged 16-73 attending either of the two sites. Main outcome measures Sensitivity, specificity, positive predictive value, and negative predictive value of the Chlamydia Rapid Test versus polymerase chain reaction assay. Relation between the visual signal of the Chlamydia Rapid Test and organism load. Results Detection rates for Chlamydia trachomatis infection with polymerase chain reaction were 4.4% (20/454) at site 1 and 11.9% (90/757) at site 2. Compared with polymerase chain reaction assay, the resolved sensitivity, specificity, positive predictive value, and negative predictive value of the Chlamydia Rapid Test was 82.6% (90/109), 98.5% (1085/1102), 84.1% (90/107), and 98.3% (1085/1104), respectively. The organism load in first void urine samples that were positive for chlamydia ranged from 7.28×102 to 6.93×106 plasmids/ml and correlated significantly with the visual signal of the Chlamydia Rapid Test (r=0.7897, P<0.001). Conclusions The performance of the new Chlamydia Rapid Test with first void male urine samples indicates that it would be an effective diagnostic tool for chlamydial infection in men. The availability of test results within an hour allows for immediate treatment and contact tracing, potentially reducing the risks of persistent infection and onward transmission. The test could also provide a simple and reliable alternative to nucleic acid amplification assays for testing of male urine in chlamydial screening programmes in high prevalence settings. PMID:19638650

  17. 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

  18. Prospective Comparison of CAPR MRA with CTA for Evaluation of Below the Knee Runoff

    PubMed Central

    Young, Phillip M.; Mostardi, Petrice M.; Glockner, James F.; Vrtiska, Terri R.; Macedo, Thanila; Haider, Clifton R.; Riederer, Stephen J.

    2013-01-01

    Purpose To prospectively compare the assessment of stenosis and radiologist confidence in the evaluation of below the knee lower extremity runoff vessels between computed tomographic angiography (CTA) and contrast enhanced magnetic resonance angiography (MRA) in a cohort of 19 clinical patients. Materials and Methods Our study was HIPAA compliant and IRB-approved. 19 consecutive patients with known or suspected peripheral arterial disease were imaged with both CTA and a recently developed MRA technique performed within 24 hours of each other and prior to any therapeutic intervention. Resulting images were randomized and interpreted in blinded fashion by four board certified radiologists with expertise in CTA and MRA. Vasculature of the lower leg was apportioned into 22 segments, 11 for each leg. For each segment, degree of stenosis and confidence of diagnosis were each determined using a three-point scale. Differences between CTA and MRA were assessed for significance using pooled histograms which were analyzed using the Wilcoxon signed rank test. Results For assessment of stenosis, there was no difference in CTA vs. MRA for 20/22 segments. For confidence of diagnosis, assessment of popliteal arteries was superior on CTA compared to MRA (p<0.05). Confidence in assessment of both tibioperoneal trunks and the left proximal anterior tibial artery was not significantly different between CTA and MRA. Confidence in assessment of all other 17 segments was superior with MRA than CTA (p<0.02). Conclusion MRA using the method described here is a promising technique for evaluating lower extremity arterial runoff. MRA had an overall superior performance in radiologist confidence when compared to CTA for imaging runoff vessels below the knee. PMID:23433414

  19. Results of a prospective randomized trial evaluating surgery versus thrombolysis for ischemia of the lower extremity. The STILE trial.

    PubMed Central

    1994-01-01

    PURPOSE: This study was designed to evaluate intra-arterial thrombolytic therapy as part of a treatment strategy for patients requiring revascularization for lower limb ischemia caused by nonembolic arterial and graft occlusion. MATERIALS AND METHODS: Patients with native arterial or bypass graft occlusion were randomized prospectively to either optimal surgical procedure or intra-arterial, catheter-directed thrombolysis with recombinant tissue plasminogen activator (rt-PA) or urokinase (UK). Thrombolysis patients required successful catheter placement into the occlusion before infusion of either rt-PA at 0.05 mg/kg/hr for up to 12 hours or UK of 250,000 units bolus followed by 4000 units/min x 4 hours, then 2000 units/min for up to 36 hours. A composite clinical outcome of death, ongoing/recurrent ischemia, major amputation, and major morbidity was the primary endpoint. Additional endpoints were reduction in surgical procedure, clinical outcome classification, length of hospitalization, and outcome by duration of ischemia. RESULTS: Randomization was terminated at 393 patients because a significant primary endpoint occurred by the first interim analysis. Failure of catheter placement occurred in 28% of patients who were randomized to lysis, and thus, were considered treatment failures. Thirty-day outcomes demonstrated significant benefit to surgical therapy compared with thrombolysis (p < 0.001), primarily because of a reduction in ongoing/recurrent ischemia (p < 0.001). However, clinical outcome classification at 30 days was similar. Stratification by duration of ischemia indicated that patients with ischemic deterioration of 0 to 14 days had lower amputation rates with thrombolysis (p = 0.052) and shorter hospital stays (p < 0.04). Patients with ischemic deterioration of > 14 days who who were treated surgically had less ongoing/recurrent ischemia (p < 0.001) and trends toward lower morbidity (p = 0.1). At 6-month follow-up, there was improved amputation

  20. A phase III trial to evaluate the efficacy, fabric integrity and community acceptance of Netprotect® using a recommended long-lasting insecticidal net as positive control

    PubMed Central

    2014-01-01

    Background The evaluation of new long-lasting insecticidal bed nets (LLINs) is coordinated by the WHO Pesticide Evaluation Scheme (WHOPES). In 2007, Netprotect® was granted WHOPES interim recommendation after Phase I and II evaluations. Present study evaluates Netprotect® in a Phase III trial in rural Cambodia. Methods A randomized, prospective longitudinal study design was used to assess the performance of Netprotect® over a period of three years, using conventionally-treated nets and a WHOPES recommended LLIN (PermaNet® 2.0) as positive controls. The primary outcomes were the physical integrity, insecticide content and cone bioassay performance using. Results The baseline deltamethrin concentration of 43% of Netprotect® nets were below the tolerance limit while 27% of PermaNet® 2.0 nets were above the target dose limits. By 36 months Netprotect® retained 35% while PermaNet® 2.0 retained 49% of baseline insecticide dose. Moreover the proportion of the inactive deltamethrin R-alpha isomer in the Netprotect® nets was 33% at the baseline and increased to 69% after three years while it was low and almost constant for PermaNet® 2.0 (3-7%). Only 71% of Netprotect® met the WHO criteria for bio-efficacy after three years while at least 80% is required. Moreover Netprotect® nets failed for the WHOPES criteria after 12 and 24 months. The reference LLIN met the WHOPES criteria throughout the study. Over the entire three years the reference LLIN did obtain significant higher mosquito mortality than Netprotect®. The physical integrity was based on the proportionate hole index and after three years, 25% of Netprotect® and 30% of PermaNet® 2.0 were in a mediocre or poor state. Conclusion Netprotect® did not meet the minimum WHO criteria for bio-efficacy after 12, 24 and 36 months. The use of a reference LLIN as positive control was helpful for data interpretation. However, for future three-year studies, it is essential that before initiating any study nets

  1. 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…

  2. The Efficacy of Supportive Learning Environments for Returning Women: An Empirical Evaluation. Research Report No. 10-76.

    ERIC Educational Resources Information Center

    Berman, Marilyn R.; And Others

    Two studies conducted at the University of Maryland during the 1973-74 academic year evaluated the efficacy of programs designed to meet the needs of women and sought to determine whether the provision of a supportive learning environment, rather than individual or group counseling, would influence women's life styles. In the first study 36…

  3. Applying Strategies of Self-Regulation and Self-Efficacy to the Design and Evaluation of Online Learning Programs

    ERIC Educational Resources Information Center

    Yang, Yong-Chil; Park, Eunmi

    2012-01-01

    This study is designed to address aspects of self-regulation and self-efficacy as they relate to critical issues in the design and evaluation of online learning programs. It begins with a discussion of the rapid growth of distance learning programs at all levels and across virtually all disciplines of educational programming. Much of this…

  4. The Science and Technology Pre-Service Teachers' Self-Efficacy Levels and Opinions about Alternative Assessment and Evaluation Approaches

    ERIC Educational Resources Information Center

    Sasmaz Oren, Fatma; Ormanci, Ummuhan; Evrekli, Ertug

    2011-01-01

    The present study aims to determine the science and technology pre-service teachers' self-efficacy levels and their opinions about alternative assessment and evaluation approaches. The study was carried out with the participation of 53 science and technology pre-service teachers studying in the Faculty of Education at Celal Bayar University. As…

  5. Improving IRT Parameter Estimates with Small Sample Sizes: Evaluating the Efficacy of a New Data Augmentation Technique

    ERIC Educational Resources Information Center

    Foley, Brett Patrick

    2010-01-01

    The 3PL model is a flexible and widely used tool in assessment. However, it suffers from limitations due to its need for large sample sizes. This study introduces and evaluates the efficacy of a new sample size augmentation technique called Duplicate, Erase, and Replace (DupER) Augmentation through a simulation study. Data are augmented using…

  6. Self-Efficacy as an Evaluation Measure for Programs in Support of Online Learning Literacies for Undergraduates

    ERIC Educational Resources Information Center

    Fletcher, K. Martin

    2005-01-01

    This study evaluated an intervention for building undergraduates' technological literacies for higher education in support of use of the learning management system and desktop applications. Self-efficacy scores between a control group and a treatment group were compared. Relationships between scores and demographic/experiential variables were also…

  7. 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…

  8. An Evaluation of the Relative Efficacy of and Children's Preferences for Teaching Strategies that Differ in Amount of Teacher Directedness

    ERIC Educational Resources Information Center

    Heal, Nicole A.; Hanley, Gregory P.; Layer, Stacy A.

    2009-01-01

    The manner in which teachers mediate children's learning varies across early childhood classrooms. In this study, we used a multi-element design to evaluate the efficacy of three commonly implemented strategies that varied in teacher directedness for teaching color- and object-name relations. Strategy 1 consisted of brief exposure to the target…

  9. 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. PMID:26908494

  10. Evaluation of safety and efficacy of zonisamide in adult patients with partial, generalized, and combined seizures: an open labeled, noncomparative, observational Indian study.

    PubMed

    Dash, Amitabh; Ravat, Sangeeta; Srinivasan, Avathvadi Venkatesan; Shetty, Ashutosh; Kumar, Vivek; Achtani, Renu; Mathur, Vivek Narain; Maramattom, Boby Varkey; Bajpai, Veeresh; Manjunath, Nanjappa C; Narayana, Randhi Venkata; Mehta, Suyog

    2016-01-01

    A prospective, multicentric, noncomparative open-label observational study was conducted to evaluate the safety and efficacy zonisamide in Indian adult patients for the treatment of partial, generalized, or combined seizures. A total of 655 adult patients with partial, generalized, or combined seizures from 30 centers across India were recruited after initial screening. Patients received 100 mg zonisamide as initiating dose as monotherapy/adjunctive therapy for 24 weeks, with titration of 100 mg every 2 weeks if required. Adverse events, responder rates, and seizure freedom were observed every 4 weeks. Efficacy and safety were also assessed using Clinicians Global Assessment of Response to Therapy and Patients Global Assessment of Tolerability to Therapy, respectively. Follow-up was conducted for a period of 24 weeks after treatment initiation. A total of 655 patients were enrolled and received the treatment and 563 completed the evaluation phase. A total of 20.92% of patients received zonisamide as monotherapy or alternative monotherapy and 59.85% patients received zonisamide as first adjunctive therapy. Compared with baseline, 41.22% of patients achieved seizure freedom and 78.6% as responder rate at the end of 24 week study. Most commonly reported adverse events were loss of appetite, weight loss, sedation, and dizziness, but discontinuation due to adverse events of drug was seen in 0.92% of patients. This open label real-world study suggests that zonisamide is an effective and well-tolerated antiepileptic drug in Indian adults for treatment of partial, generalized as well as combined seizures type. No new safety signals were observed. PMID:27013882

  11. Evaluation of safety and efficacy of zonisamide in adult patients with partial, generalized, and combined seizures: an open labeled, noncomparative, observational Indian study

    PubMed Central

    Dash, Amitabh; Ravat, Sangeeta; Srinivasan, Avathvadi Venkatesan; Shetty, Ashutosh; Kumar, Vivek; Achtani, Renu; Mathur, Vivek Narain; Maramattom, Boby Varkey; Bajpai, Veeresh; Manjunath, Nanjappa C; Narayana, Randhi Venkata; Mehta, Suyog

    2016-01-01

    A prospective, multicentric, noncomparative open-label observational study was conducted to evaluate the safety and efficacy zonisamide in Indian adult patients for the treatment of partial, generalized, or combined seizures. A total of 655 adult patients with partial, generalized, or combined seizures from 30 centers across India were recruited after initial screening. Patients received 100 mg zonisamide as initiating dose as monotherapy/adjunctive therapy for 24 weeks, with titration of 100 mg every 2 weeks if required. Adverse events, responder rates, and seizure freedom were observed every 4 weeks. Efficacy and safety were also assessed using Clinicians Global Assessment of Response to Therapy and Patients Global Assessment of Tolerability to Therapy, respectively. Follow-up was conducted for a period of 24 weeks after treatment initiation. A total of 655 patients were enrolled and received the treatment and 563 completed the evaluation phase. A total of 20.92% of patients received zonisamide as monotherapy or alternative monotherapy and 59.85% patients received zonisamide as first adjunctive therapy. Compared with baseline, 41.22% of patients achieved seizure freedom and 78.6% as responder rate at the end of 24 week study. Most commonly reported adverse events were loss of appetite, weight loss, sedation, and dizziness, but discontinuation due to adverse events of drug was seen in 0.92% of patients. This open label real-world study suggests that zonisamide is an effective and well-tolerated antiepileptic drug in Indian adults for treatment of partial, generalized as well as combined seizures type. No new safety signals were observed. PMID:27013882

  12. Evaluation of efficacy of regional and local anesthesia techniques in arteriovenous fistula criation for dialysis.

    PubMed

    Shoshiashvili, V; Tataradze, A; Beglarishvili, L; Managadze, L; Chkhotua, A

    2014-11-01

    Both, regional and local anesthesia are used for dialysis arterio-venous fistula (AVF) formation in end-stage renal disease patients. There are no prospective, randomized clinical trials comparing effectiveness of these types of anesthesia in these patients. It was a prospective, randomized study. 103 patients with ESRD underwent dialysis AVF operations on upper limb. The patients have been randomly divided in two groups. Group I: 49 patients in whom the operations have been done under the local anesthesia; and Group II: 54 patients in whom the operation has been performed under the vertical infraclavicular block. Radio-Cefalic, Brachio-Cefalic and Brachio-Basilic(I stage transposition) fistulas have been created in all patients.Influence of the type of anesthesia on intra- and postoperative pain has been evaluated and compared between the groups. The mean follow-up was 359.5 days in Group I and 340.5 days in Group II (p-NS).The mean patients age was 59.7±13.1 years and 60.1±14 years in local and regional anesthesia groups, respectively (p=NS). For the whole group, significantly less number of patients with regional anesthesia required additional perioperative analgesics as compared with the local anesthesia group (p=0.0363). Time to postoperative pain initiation was significantly higher in Group II (2.3 hours) as compared with the Group I (1.7 hours, p=0.0477). The need for postoperative pain killers was significantly less in regional as compared with the local anesthesia (p=0.0318). Duration of operation was significantly less in regional (67.5 min.) as compared with local anesthesia (134.7 min. p=0.0007) group. This difference has been detected in Brachio-Cefalic and Brachio-Basilic fistulas (p=0.0257 and 0.001, respectively) but not in Radio-Cefalic one. No anesthesia related complications have been detected. Insufficiency of regional anesthesia has been identified in 3 cases (5.5%).In 5 patients from regional anesthesia group (9.4%) as a result of

  13. 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. PMID:20230586

  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. 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 ...

  16. 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

    2016-04-01

    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. PMID:27007594

  17. 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

  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. 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.

  20. 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

  1. Evaluation of 5-Year Trends in Knee Society Scores Stratified by Comorbidities: A Prospective, Longitudinal Study.

    PubMed

    Jauregui, Julio J; Issa, Kimona; Cherian, Jeffrey J; Harwin, Steven F; Given, Kristin; Mont, Michael A

    2016-01-01

    Total knee arthroplasties (TKAs) are reliable procedures for treating end-stage knee osteoarthritis with excellent long-term outcomes. The purpose of this study was to longitudinally evaluate temporal trends of Knee Society Scores (KSS) after TKA and to identify potential demographic and comorbid factors that affect these outcomes. This prospective study evaluated 281 patients (108 men and 173 women) with a mean age of 66 years (range, 39-80 years) who underwent primary TKA (minimum follow-up 5 years). During each follow-up visit, KS objective, function, and total scores were evaluated. The effects of different demographics and comorbidities on outcomes were further analyzed using multivariate regression analysis. Following TKA, peak mean KSS were observed at 1-year follow-up (mean, 92 points), after which there was no significant difference in scores at 5 years compared with 1-year follow-up (mean, 92 points). KS function scores were observed to be unchanged from preoperative levels (mean, 53 points) and at 6 weeks (mean, 56 points). These were significantly higher at 3 months (mean, 78 points) and reached a maximum mean peak at 1 year (mean, 85 points). KS objective scores increased earlier than function scores. The demographic variables and comorbidities that demonstrated a significantly negative impact in KS function scores were increased age, female gender, higher body mass index, and several medical comorbidities including immunological and neurological disease, and neoplasm. Race was the only variable that significantly decreased the KS objective scores. KSS after TKA follow temporal trends with scores initially unchanged from preoperative levels for the objective component, but the scores increased for the functional component. All components demonstrated higher levels compared with preoperative scores by 3 months and peaked at 1-year follow-up. At 5-year follow-up, all mean KSS were unchanged relative to peak scores seen at 1 year. Various patient

  2. 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…

  3. 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…

  4. 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…

  5. Item response modeling: an evaluation of the children's fruit and vegetable self-efficacy questionnaire

    Technology Transfer Automated Retrieval System (TEKTRAN)

    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) procedur...

  6. 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…

  7. A Psychometric Evaluation of the Parent Self-Efficacy in Managing the Transition to School Scale

    ERIC Educational Resources Information Center

    Giallo, Rebecca; Kienhuis, Mandy; Treyvaud, Karli; Matthews, Jan

    2008-01-01

    The psychometric properties of the Parent Self-efficacy in Managing the Transition to School Scale (PSMTSS) were investigated with a sample of 763 mothers whose children were starting primary school in Australia. Exploratory factor analysis identified two factors, Efficacy and Worry, accounting for 56.6% of the total variance in parent…

  8. 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…

  9. 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. PMID:24472698

  10. Evaluation of the efficacy of Alka-Seltzer Effervescent in gastric acid neutralization.

    PubMed

    Chen, C T; Toung, T J; Haupt, H M; Hutchins, G M; Cameron, J L

    1984-03-01

    A commercially available antacid, a mixture of sodium and potassium bicarbonates and citric acid (Alka-Seltzer Effervescent), was evaluated experimentally and clinically for its efficacy in neutralizing 0.1 N HCl and gastric contents. In an in vitro titration study, Alka-Seltzer Effervescent buffered 5-30 times the volume of HCl with a pH between 1.0 and 2.0 to above a pH of 2.5. In an isolated canine pulmonary lobe model, aspiration of the antacid or acid-antacid mixture caused only a mild increase in lobe weight and did not increase intrapulmonary shunting. In the clinical study, when the antacid was given 5-40 min before administration of general anesthesia in a group of patients for emergency surgery, the pH of the gastric contents in each patient was increased to above 4.0. This contrasts with the control group of patients, which showed 50% (P less than 0.05) of the patients were at risk when no antacid was administered. Preoperative administration of Alka-Seltzer effectively increases the pH of the gastric contents in patients undergoing emergency surgery. PMID:6703349

  11. Intrathoracic tracheal reconstruction with a collagen-conjugated prosthesis: evaluation of the efficacy of omental wrapping.

    PubMed

    Teramachi, M; Okumura, N; Nakamura, T; Yamamoto, Y; Kiyotani, T; Takimoto, Y; Matsuda, S; Ikada, Y; Shimizu, Y

    1997-04-01

    Reconstructions of the intrathoracic trachea in 24 dogs were done with the use of 50 mm long collagen-conjugated tracheal prostheses. Omental wrapping was also done in 14 of the dogs (omentopexy group) to evaluate the efficacy of this option in comparison with results in the other 10 dogs (control group). All 24 dogs had uneventful postoperative courses and were killed at 4 weeks or 3, 6, or 12 months after the operation. Better epithelialization and fewer complications, such as mesh exposure and luminal stenosis, were observed in the omentopexy group than in the control group. Angiography and analysis of regenerated blood vessels revealed that vessel ingrowth had started within 4 weeks and that vessel formation reached its maximal point within 6 to 12 months in the omentopexy group. In contrast, revascularization of the subepithelial region in the control group was poor even after 3 months, and vessel formation continued for as long as 12 months. The differences between the two groups were considered to be mainly a result of the speed of blood vessel ingrowth into the regenerated mucosa. We conclude that our prosthesis can be used safely for intrathoracic tracheal reconstruction and that omental wrapping is a useful supplementary method that reduces the occurrence of complications. PMID:9104979

  12. Evaluation of efficacy and safety of glycopyrrolate - xylazine - propofol anesthesia in buffalo calves

    PubMed Central

    Potliya, Sandeep; Kumar, Ashok; Kumar, Sandeep; Singh, Sukhbir; Kumar, Sarvan

    2015-01-01

    Aim: To evaluate the efficacy and safety of glycopyrrolate - xylazine - propofol anesthesia in buffalo calves. Materials and Methods: The study was conducted on six clinically healthy male buffalo calves, 6-12 months of age, and weighing between 130 and 170 kg. In all the animals; glycopyrrolate (0.01 mg/kg, IM), xylazine (0.1 mg/kg, IM) and 1% propofol as single bolus (1.5 mg/kg, intravenous), were administered. The parameters observed included behavioral changes, physiological; hematological and blood biochemical parameters. Results: Muzzle and nostrils became dry in all the animals after glycopyrrolate administration. A decrease in spontaneous activity and mild cutaneous analgesia was noticed after xylazine administration. After administration of propofol, loss of swallowing reflex, palpebral reflex, corneal reflexes, periosteal reflex and complete analgesia was observed. There was no significant change in rectal temperature and heart rate. However, heart rate remained elevated during anesthesia. Respiratory rate decreased significantly after propofol administration. There was a significant increase in plasma glucose after the xylazine and propofol administration which remained elevated till recovery. A significant decrease in chloride level was seen after propofol administration. Conclusions: Glycopyrrolate - xylazine - propofol anesthetic combination may safely be used for short duration anesthesia in buffalo calves. PMID:27047082

  13. 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.

  14. Evaluating the efficacy of restoration plantings through DNA barcoding of frugivorous bird diets.

    PubMed

    Galimberti, A; Spinelli, S; Bruno, A; Mezzasalma, V; De Mattia, F; Cortis, P; Labra, M

    2016-08-01

    Frugivores are critical components of restoration programs because they are seed dispersers. Thus, knowledge about bird-plant trophic relationships is essential in the evaluation of the efficacy of restoration processes. Traditionally, the diet of frugivores is characterized by microscopically identifying plant residues in droppings, which is time-consuming, requires botanical knowledge, and cannot be used for fragments lacking detectable morphological characteristics (e.g., fragmented seeds and skins). We examined whether DNA barcoding can be used as a universal tool to rapidly characterize the diet of a frugivorous bird, Eurasian blackcap (Sylvia atricapilla). We used the DNA barcoding results to assess restoration efforts and monitor the diversity of potentially dispersed plants in a protected area in northern Italy. We collected 642 Eurasian Blackcap droppings at the restored site during the autumn migration over 3 years. Intact seeds and fragmented plant material were analyzed at 2 plastidial barcode loci (rbcL and trnH-psbA), and the resulting plant identifications were validated by comparison with a reference molecular data set of local flora. At least 17 plant species, including 7 of the 11 newly transplanted taxa, were found. Our results demonstrate the potential for DNA barcoding to be used to monitor the effectiveness of restoration plantings and to obtain information about fruit consumption and dispersal of invasive or unexpected plant species. Such an approach provides valuable information that could be used to study local plant biodiversity and to survey its evolution over time. PMID:26864475

  15. Evaluation of Methyl Bromide Alternatives Efficacy against Soil-Borne Pathogens, Nematodes and Soil Microbial Community

    PubMed Central

    Xie, Hongwei; Yan, Dongdong; Mao, Liangang; Wang, Qiuxia; Li, Yuan; Ouyang, Canbin; Guo, Meixia; Cao, Aocheng

    2015-01-01

    Methyl bromide (MB) and other alternatives were evaluated for suppression of Fusarium spp., Phytophthora spp., and Meloidogyne spp. and their influence on soil microbial communities. Both Fusarium spp. and Phytophthora spp. were significantly reduced by the MB (30.74 mg kg-1), methyl iodide (MI: 45.58 mg kg-1), metham sodium (MS: 53.92 mg kg-1) treatments. MS exhibited comparable effectiveness to MB in controlling Meloidogyne spp. and total nematodes, followed by MI at the tested rate. By contrast, sulfuryl fluoride (SF: 33.04 mg kg-1) and chloroform (CF: 23.68 mg kg-1) showed low efficacy in controlling Fusarium spp., Phytophthora spp., and Meloidogyne spp. MB, MI and MS significantly lowered the abundance of different microbial populations and microbial biomass in soil, whereas SF and CF had limited influence on them compared with the control. Diversity indices in Biolog studies decreased in response to fumigation, but no significant difference was found among treatments in PLFA studies. Principal component and cluster analyses of Biolog and PLFA data sets revealed that MB and MI treatments greatly influenced the soil microbial community functional and structural diversity compared with SF treatment. These results suggest that fumigants with high effectiveness in suppressing soil-borne disease could significantly influence soil microbial community. PMID:25723395

  16. 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

  17. 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. PMID:23334989

  18. Murine Model Imitating Chronic Wound Infections for Evaluation of Antimicrobial Photodynamic Therapy Efficacy.

    PubMed

    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

  19. 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

  20. 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. PMID:26423278

  1. Results of a prospective study evaluating the effects of mantle irradiation on pulmonary function

    SciTech Connect

    Smith, L.M.; Mendenhall, N.P.; Cicale, M.J.; Block, E.R.; Carter, R.L.; Million, R.R.

    1989-01-01

    Thirty patients with Stages I-III Hodgkin's disease receiving mantle irradiation were prospectively evaluated prior to therapy with spirometry, lung volumes, and tests of diffusing capacity (DLCO). Follow-up examinations were performed at 3, 6, and 12 months and then yearly. Sixteen patients had Hodgkin's disease involving the mediastinum at presentation, 10 were smokers, and 16 received either preirradiation or postirradiation chemotherapy. Mantle doses ranged between 2300 cGy and 4000 cGy (mode of 3750 cGy) given at 150 cGy to 170 cGy tumor dose per day with split-course technique. Twenty patients have been tested greater than or equal to 4 years after treatment with a median time from treatment to last pulmonary function test of 8 years. Changes over time in spirometry included an early, mild decrease in both forced vital capacity (FVC) and forced expiratory volume at 1 second (FEV1), which returned to baseline by 2 years and then gradually decreased to a 10-15% deficit as compared with predicted values at 6-10 years. Additionally, there was a very slight decrease in FEV1/FVC beginning at 1 year and gradually increasing to an 8% deficit at 6-10 years. Changes over time in lung volumes included a mild nadir of total lung capacity (TLC) and functional residual capacity (FRC) at 6 months to a year, which returned to baseline at 2-4 years and then gradually dropped to a 5-10% deficit at 6-10 years. Mean DLCO for the study group was 20% below predicted values prior to treatment and dropped to a low of 30% below predicted at 6 months following treatment, then gradually returned to baseline by 4 years and showed continued improvement to an overall deficit of approximately 10% at 6-10 years.

  2. Prospective Evaluation of Three Rapid Diagnostic Tests for Diagnosis of Human Leptospirosis

    PubMed Central

    Goris, Marga G. A.; Leeflang, Mariska M. G.; Loden, Martin; Wagenaar, Jiri F. P.; Klatser, Paul R.; Hartskeerl, Rudy A.; Boer, Kimberly R.

    2013-01-01

    Background Diagnosis of leptospirosis by the microscopic agglutination test (MAT) or by culture is confined to specialized laboratories. Although ELISA techniques are more common, they still require laboratory facilities. Rapid Diagnostic Tests (RDTs) can be used for easy point-of-care diagnosis. This study aims to evaluate the diagnostic performance of the RDTs LeptoTek Dri Dot, LeptoTek Lateral Flow, and Leptocheck-WB, prospectively. Methodology During 2001 to 2012, one or two of the RDTs at the same time have been applied prior to routine diagnostics (MAT, ELISA and culture) on serum specimens from participants sent in for leptospirosis diagnosis. The case definition was based on MAT, ELISA and culture results. Participants not fulfilling the case definition were considered not to have leptospirosis. The diagnostic accuracy was determined based on the 1st submitted sample and paired samples, either in an overall analysis or stratified according to days post onset of illness. Results The overall sensitivity and specificity for the LeptoTek Dri Dot was 75% respectively 96%, for the LeptoTek Lateral Flow 78% respectively 95%, and for the Leptocheck-WB 78% respectively 98%. Based on the 1st submitted sample the sensitivity was low (51% for LeptoTek Dri Dot, 69% for LeptoTek Lateral Flow, and 55% for Leptocheck-WB), but substantially increased when the results of paired samples were combined, although accompanied by a lower specificity (82% respectively 91% for LeptoTek Dri Dot, 86% respectively 84% for LeptoTek Lateral Flow, and 80% respectively 93% for Leptocheck-WB). Conclusions All three tests present antibody tests contributing to the diagnosis of leptospirosis, thus supporting clinical suspicion and contributing to awareness. Since the overall sensitivity of the tested RDTs did not exceed 80%, one should be cautious to rely only on an RDT result, and confirmation by reference tests is strongly recommended. PMID:23875034

  3. 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. PMID:24808236

  4. 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

  5. Prospective evaluation of healthy Ragdoll cats for chronic kidney disease by routine laboratory parameters and ultrasonography.

    PubMed

    Paepe, Dominique; Bavegems, Valérie; Combes, Anaïs; Saunders, Jimmy H; Daminet, Sylvie

    2013-10-01

    Ragdoll breeder organisations often forewarn Ragdoll cat owners that renal problems may develop as a result of polycystic kidney disease (PKD), chronic interstitial nephritis, familial renal dysplasia or nephrocalcinosis. Healthy Ragdoll and non-Ragdoll cats were prospectively evaluated by measuring serum creatinine and urea concentrations, routine urinalysis and abdominal ultrasonography. All Ragdoll cats also underwent genetic PKD testing. One hundred and thirty-three Ragdoll and 62 control cats were included. Ragdoll cats had significantly lower serum urea concentrations and higher urinary specific gravity. However, median creatinine concentration, median urinary protein-to-creatinine ratio, and the proportion of cats with serum creatinine or urea concentration exceeding the reference interval did not differ. One or more renal ultrasonographical changes were detected in 66/133 (49.6%) Ragdoll and in 25/62 (40%) control cats. Ragdoll cats showed significantly more frequent segmental cortical lesions (7.5% versus 0%), abnormal renal capsule (19.5% versus 8%) and echogenic urine (51.9% versus 25.8%). Chronic kidney disease (CKD) was ultrasonographically suspected in 7/133 (5.3%) Ragdoll and in none of the control cats, which approached significance. Laboratory parameters confirmed kidney dysfunction only in 1/7 of these Ragdoll cats. All Ragdoll cats were PKD negative. In conclusion, first, breed-specific serum creatinine reference intervals are not likely required for Ragdoll cats. Second, renal ultrasonographical abnormalities are common, both in Ragdoll and non-Ragdoll cats. Third, healthy young Ragdoll cats are uncommonly affected by PKD and CKD, but an increased susceptibility of Ragdoll cats to develop CKD cannot be excluded. Finally, Ragdoll cats are predisposed to segmental cortical lesions, which may indicate renal infarction or cortical scarring. PMID:23413268

  6. 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.

  7. [Prostate cancer-the role of docetaxel on castration-resistant prostate cancer: evaluation of efficacy and subsequent treatment].

    PubMed

    Suzuki, Kazuhiro

    2012-10-01

    Docetaxel is used as a standard therapy for castration-resistant prostate cancer(CRPC). A recent report on the safety and efficacy of decetaxel, based on post-marketing surveillance in Japan, showed similar profiles of PSA response and adverse events. For the determination of efficacy, PSA 30% or 50% response, and an imaging examination are evaluated. One most understand the specific patterns of PSA levels, ie, PSA flare, the transient increase of PSA, and PSA stabilization. Docetaxel would be discontinued based on treatment efficacy, further treatment modalities, adverse events, etc. Now that new hormonal and cytotoxic agents are under development, we must accumulate clinical features of patients treated with docetaxel to construct a better future treatment strategy for CRPC. PMID:23064057

  8. 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

  9. Evaluation of the efficacy of orange roughy (Hoplostetbus atlanticus) oil in subjects with dry skin.

    PubMed

    Domoto, N; Koriyama, T; Chu, B-S; Tsuji, T

    2012-08-01

    Moisturizers have beneficial effects in treating dry skin. The objective of this study was to evaluate the effect of orange roughy (Hoplostethus atlanticus) oil, a marine-derived wax ester, on skin dryness in comparison with a reference commercially available petrolatum-based moisturizer (Vaseline) and untreated control. Subjects (n = 24) with moderate to severe skin dryness at the lower limb of legs (Study 1) and with certain degree of skin dryness on the face and the forearms (n = 22, Study 2) were treated twice a day for 42 consecutive days with the test products in randomized clinical trials. Transepidermal water loss (TEWL) was measured at the beginning and the end of Study 1, whereas skin hydration was measured at the beginning, after 3 and 6 weeks of the application (the end of the study) in Study 2. Changes in the skin dryness were assessed by a dermatologist using a video microscopy. In Study 1, the dryness score of skin applied with orange roughy oil improved significantly (P < 0.01) in 6 weeks. The skin looked smooth with no or little dry scaly skin. Orange roughy oil was evaluated with a 60% efficacy in treating skin dryness by the expert, which comparable to that of petrolatum (68%). No significant change in TEWL was found either in orange roughy oil or petrolatum treatment, although the values showed a tendency to improve in both cases. Similarly, the results of the skin capacitance in Study 2 showed a significant improvement of the skin symptoms after 3 and 6 weeks. These results showed that the performance of orange roughy oil in treating skin dryness was comparable to that of petrolatum. PMID:22554123

  10. Resveratrol-procyanidin blend: nutraceutical and antiaging efficacy evaluated in a placebocontrolled, double-blind study

    PubMed Central

    Buonocore, Daniela; Lazzeretti, Angelo; Tocabens, Pedro; Nobile, Vincenzo; Cestone, Enza; Santin, Giada; Bottone, Maria G; Marzatico, Fulvio

    2012-01-01

    Background Skin is constantly exposed to pro-oxidant environmental stress from several sources, including air pollutants, ultraviolet solar light, and chemical oxidants. Reactive oxygen species have been implicated in age-related skin disorders. Dietary bioactive antioxidant compounds, such as polyphenols, have beneficial effects on skin health. The advantage of a nutritional administration route is that blood delivers nutraceutical bioactive compounds continuously to all skin compartments, ie, the epidermis, dermis, and subcutaneous fat. The purpose of this study was to evaluate the topical and systemic effects of a dietary supplement containing resveratrol and procyanidin on age-related alterations to the skin, the skin antioxidant pool, and systemic oxidative stress levels. Methods An instrumental study was performed in 50 subjects (25 treated with supplements and 25 with placebo) to identify clinical features induced by chronoaging or photoaging. Product efficacy was evaluated after 60 days of treatment in terms of in vivo and in situ skin hydration, elasticity, and skin roughness levels, systemic oxidative stress levels by plasmatic derivatives of reactive oxygen metabolites and oxyadsorbent tests, and extent of the skin antioxidant pool. Results After 60 days of treatment, values for systemic oxidative stress, plasmatic antioxidant capacity, and skin antioxidant power had increased significantly. Additionally, skin moisturization and elasticity had improved, while skin roughness and depth of wrinkles had diminished. Intensity of age spots had significantly decreased, as evidenced by improvement in the individual typological angle. Conclusion Nutraceutical and pharmacological intervention with a supplement characterized by a specific blend of resveratrol and procyanidin may be a promising strategy to support treatments for the reduction of skin wrinkling, as well as reducing systemic and skin oxidative stress. PMID:23071399

  11. Development and psychometric evaluation of an information literacy self-efficacy survey and an information literacy knowledge test*

    PubMed Central

    Tepe, Rodger; Tepe, Chabha

    2015-01-01

    Objective To develop and psychometrically evaluate an information literacy (IL) self-efficacy survey and an IL knowledge test. Methods In this test–retest reliability study, a 25-item IL self-efficacy survey and a 50-item IL knowledge test were developed and administered to a convenience sample of 53 chiropractic students. Item analyses were performed on all questions. Results The IL self-efficacy survey demonstrated good reliability (test–retest correlation = 0.81) and good/very good internal consistency (mean κ = .56 and Cronbach's α = .92). A total of 25 questions with the best item analysis characteristics were chosen from the 50-item IL knowledge test, resulting in a 25-item IL knowledge test that demonstrated good reliability (test–retest correlation = 0.87), very good internal consistency (mean κ = .69, KR20 = 0.85), and good item discrimination (mean point-biserial = 0.48). Conclusions This study resulted in the development of three instruments: a 25-item IL self-efficacy survey, a 50-item IL knowledge test, and a 25-item IL knowledge test. The information literacy self-efficacy survey and the 25-item version of the information literacy knowledge test have shown preliminary evidence of adequate reliability and validity to justify continuing study with these instruments. PMID:25517736

  12. Testing sustainability by prospective and retrospective demographic analyses: evaluation for palm leaf harvest.

    PubMed

    Zuidema, Pieter A; De Kroon, Hans; Werger, Marinus J A

    2007-01-01

    Harvesting nontimber forest products (NTFPs) is a major economic activity in tropical forests. As many NTFPs are overexploited, sustainability analyses are required to set harvest guidelines. Here we introduce and apply a new approach to evaluating sustainability, which combines prospective (elasticity) and retrospective (Life Table Response Experiments [LTRE]) demographic analyses of matrix population models. We relate the elasticity of vital rates (representing their importance for population growth rate, lamda) to their contribution to harvest-induced change in lamda ("LTRE contribution"). When high-elasticity vital rates have a low LTRE contribution, exploitation is potentially sustainable as negative effects for population growth are buffered. If the reverse is found, there is little scope for sustainability because crucial vital rates are affected. Our approach is less sensitive to chance fluctuations than the commonly used sustainability criterion of lamda = 1.0, as it does not depend on the absolute value of lamda. We applied this analysis to Geonoma deversa, a clustered forest understory palm. We studied three experimentally defoliated and control populations in a Bolivian rainforest during two years. Cutting all leaves of large ramets did not change mortality but strongly affected growth and reproduction. In spite of severe changes in some vital rates, population growth rate was not significantly reduced after defoliation. A literature review revealed that six other understory palms species responded very similarly to defoliation. The combination of LTRE contributions and elasticity analyses showed that low-elasticity vital rates were mainly responsible for the defoliation-induced change in lamda for Geonoma deversa. For two other understory palms (Astrocaryum mexicanum and Chamaedorea radicalis) new demographic analyses yielded very similar results. For Geonoma, the LTRE contribution-elasticity relation strongly changed when we mimicked harvest damage

  13. 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

  14. Prospective Evaluation of Low-Dose Ketoconazole Plus Hydrocortisone (HC) in Docetaxel Pre-treated Castration-Resistant Prostate Cancer (CRPC) Patients

    PubMed Central

    Lo, Ernest N.; Beckett, Laurel A.; Pan, Chong-Xian; Robles, Daniel; Suga, Jennifer M.; Sands, Jacob M.; Lara, Primo N.

    2015-01-01

    Background Ketoconazole is a well-known CYP-17-targeted systemic treatment for castration-resistant prostate cancer (CRPC). However, most of the published data has been in the pre-chemotherapy setting; its efficacy in the post-chemotherapy setting has not been as widely described. Chemotherapy-naïve patients treated with attenuated doses of ketoconazole (200-300 mg three times daily) had prostate specific antigen (PSA) response rate (greater than 50% decline) of 21% to 62%. We hypothesized that low-dose ketoconazole would likewise possess efficacy and tolerability in the CRPC post-chemotherapy state. Methods Men with CRPC and performance status (PS) 0-3, adequate organ function and who had received prior docetaxel were treated with low-dose ketoconazole (200 mg PO three times daily) and hydrocortisone (20 mg PO qAM and 10 mg PO qPM) until disease progression. Primary endpoint was PSA response rate (greater than 50% reduction from baseline) where a PSA response rate of 25% was to be considered promising for further study (versus a null rate of less than 5%); 25 patients were required. Secondary endpoints included PSA response greater than 30% from baseline, progression-free survival (PFS), duration of stable disease, and evaluation of adverse events (AEs). Results Thirty patients were accrued with median age of 72 years (range 55-86) and median pre-treatment PSA of 73 ng/ml (range 7-11,420). Twenty-nine patients were evaluable for response and toxicity. PSA response (>50% reduction) was seen in 48% of patients; PSA response (>30% reduction) was seen in 59%. Median PFS was 138 days; median duration of stable disease was 123 days. Twelve patients experienced grade 3 or 4 AEs. Of the 17 grade 3 AEs, only 3 were attributed to treatment. None of the 2 grade 4 AEs was considered related to treatment. Conclusions In docetaxel pre-treated CRPC patients, low-dose ketoconazole and hydrocortisone is a well-tolerated, relatively inexpensive and clinically active treatment

  15. Prospective study of the hemodynamic behavior of ophthalmic arteries in postpartum preeclamptic women: A doppler evaluation.

    PubMed

    Alves Borges, José Hilário; Goes, Daniela A; de Araújo, Lúcio Borges; Dos Santos, Maria Célia; Debs Diniz, Angélica Lemos

    2016-02-01

    The aim of this study was to evaluate the hemodynamic behavior of the ophthalmic artery by means of the Doppler ultrasound, in postpartum preeclamptic women. It was an observational prospective study with 44 postpartum preeclamptic women (group 1) and 49 postpartum normal women with normal blood pressure and with no previous illnesses known (group 2). All the pregnant women had a Doppler ultrasound exam of the ophthalmic artery in the immediate puerperium, that is, 10 days for the delivery (time 1). Group 1 was then followed prospectively, 26 patients of which returned to the last test in the remote puerperium in 45 days (time 2) and 29 patients returned to the last test in the remote puerperium in 90 days (time 3). All these women had preeclampsia before the delivery. The resistance index (RI), pulsatility index (PI), peak systolic velocity (PSV), end diastolic flow velocity (EDV), second peak of systolic velocity (P2), and the peak ratio (PR) were calculated. The data obtained are expressed in average and standard deviation, by using the Lilliefors test for normality. The average of the Doppler indexes in groups 1 and 2 was compared by means of test t of the student. Group 1 was analyzed separately, comparing the three times, using the test of ANOVA for repetitive measures and Tukey post-hoc range test. In the "Results" section, the statically meaningful differences in RI, PI, P2, RPV, and EDV (p < 0.0001, p < 0.0001, p < 0.0009, p < 0.0001, p < 0.0028) were found in the immediate puerperium of group 1 in relation to group 2, indicating the persistence of hyperperfusion and orbital vasodilatation in the immediate postpartum period in patients who had complicated pregnancies previously due to preeclampsia. In the evolutionary analysis of group 1, comparing the Doppler indexes between the immediate and late puerperium, statistically relevant differences between the rates of RI, P2, and PR (p < 0,01) were observed, showing a raise of RI and reduction of P2 and PR

  16. Psychometric evaluations of the efficacy expectations and Outcome Expectations for Exercise Scales in African American women.

    PubMed

    Murrock, Carolyn J; Gary, Faye

    2014-01-01

    This secondary analysis tested the reliability and validity of the Self-Efficacy for Exercise (SEE) and the Outcome Expectations for Exercise (OEE) scales in 126 community dwelling, middle aged African American women. Social Cognitive Theory postulates self-efficacy is behavior age, gender and culture specific. Therefore, it is important to determine ifself-efficacy scales developed and tested in older Caucasian female adults are reliable and valid in middle aged, minority women. Cronbach's alpha and construct validity using hypothesis testing and confirmatory factor analysis supported the reliability and validity of the SEE and OEE scales in community dwelling, middle aged African American women. PMID:25612395

  17. Roosevelt Hot Springs/hot-dry-rock prospect and evaluation of the Acord 1-26 well

    SciTech Connect

    Shannon, S.S. Jr.; Goff, F.; Rowley, J.C.; Pettitt, R.A.; Vuataz, F.D.

    1983-01-01

    Previous hot, dry rock (HDR) geothermal resource evaluation efforts have identified the Roosevelt Hot Springs KGRA as a prime HDR target. The size of the HDR resource is estimated to be at least eight times larger than the adjacent hydrothermal resource. Further research activities to evaluate this HDR resource have involved review of data from the Acord hot dry well, the seismic structure of the area, fluid geochemistry, and hydrology of a shallow aquifer. These recent results are summarized and the most likely HDR prospect area is identified.

  18. 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

  19. 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

  20. 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

  1. Prospective evaluation of /sup 99//sup m/Tc-IDA cholescintigraphy and Gray-scale ultrasound in the diagnosis of acute cholecystitis

    SciTech Connect

    Ralls, P.W.; Colletti, P.M.; Halls, J.M.; Siemsen, J.K.

    1982-07-01

    Prospective analysis of the efficacy of /sup 99//sup m/Tc-IDA cholescintigraphy and cholecystosonography showed that both are excellent techniques for assessing patients with suspected acute cholecystitis (accuracy 84.7% and 88.1% respectively). Consequently, the choice of tests selected to evaluate patients with suspected acute cholecystitis depends on several factors, including; (a.) quality of equipment available; (b.) capability of the technologist performing the examination; (c.) relative experience of the physician supervising the examination; and (d.) willingness of the surgical consultant to accept a positive examination as sufficient evidence to perform emergency surgery. The authors feel that cholecystosonography should be used to asses the presence of acute cholecystitis in jaundiced patients because of its capability in the assessment of bile duct dilation, and because of the lower reliability of cholescintigraphy when bile duct obstruction is possible (i.e., in jaundice). Ancillary findings in cholecystosonography and cholescintigraphy can aid in the differential diagnosis of acute right upper quadrant pain syndromes.

  2. 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

  3. Comparison and Efficacy of Low-Dose and Standard-Dose Tamsulosin and Alfuzosin in Medical Expulsive Therapy for Lower Ureteral Calculi: Prospective, Randomized, Comparative Study

    PubMed Central

    Cha, Woo Heon; Choi, Jae Duck; Seo, Young Jin; Lee, Kyungseop

    2012-01-01

    Purpose Typically in Korea, for a standard dose (0.4 mg) of tamsulosin, two low doses (0.2 mg) are administered. The aim of this study was to evaluate and compare the efficacy of tamsulosin (0.2 mg and 0.4 mg) and alfuzosin (10 mg) in the treatment of lower ureteral stones. Materials and Methods A total of 141 patients presenting with a single 4- to 10-mm sized lower ureteral stone were randomly assigned to 4 groups. Patients in group 1 (n=41) and group 2 (n=30) received an oral dose of 0.2 mg tamsulosin once and twice daily, respectively, and patients in group 3 (n=36) received a daily oral dose of 10 mg alfuzosin. Patients in group 4 (n=34) received trospium chloride only. The spontaneous passage of stones, the stone expulsion time, and adverse effects were evaluated. Results There were no significant differences in patient background, including age, sex, BMI, stone size, stone side, and symptom duration. The spontaneous stone passage rate through the ureter was higher and the stone expulsion time was faster in groups 1, 2, and 3 than in group 4. There were no statistically different changes in groups 1, 2, and 3. The adverse effects observed in all groups were comparable and were mild. Conclusions Tamsulosin at 0.2 mg and 0.4 mg and alfuzosin (10 mg) proved to be safe and effective. A first cycle of medical expulsive therapy with tamsulosin 0.2 mg could be considered as an option in the management of single lower ureteral stone. PMID:22670195

  4. Moxifloxacin Pharmacokinetic Profile and Efficacy Evaluation in Empiric Treatment of Community-Acquired Pneumonia

    PubMed Central

    Hardlei, Tore Forsingdal; Brock, Birgitte; Jensen-Fangel, Søren; Kragh Thomsen, Marianne; Petersen, Eskild; Kreilgaard, Mads

    2015-01-01

    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.) PMID:25666151

  5. Evaluation of the efficacy of 2% curcumin gel in the treatment of experimental periodontitis

    PubMed Central

    Hosadurga, Rajesh Ramesh; Rao, S. N.; Jose, Jobin; Rompicharla, Narayana Charyulu; Shakil, Moidin; Shashidhara, R.

    2014-01-01

    Context: Local drug delivery (LDD) systems have been proposed for the treatment of periodontitis. Curcumin could be a suitable agent as LDD for the treatment of periodontitis. Aim: To formulate, evaluate the anti-inflammatory activity and to assess the duration of the action and the efficacy of 2% curcumin gel in the treatment of experimental periodontitis in Wistar albino rat model. Settings and Design: Twenty-one Wistar albino rats were randomly assigned to three groups. Periodontitis was induced using ligature model. Group 1: Control; group 2: Plain gel, and group 3: 2% curcumin gel. Materials and Methods: About 2% curcumin gel was prepared. The anti-inflammatory activity and duration of action was assessed. Silk ligature 5-0 was used to induce periodontitis. Gingival index (GI) and probing pocket depth (PPD) were measured. Treatment was done. The rats were sacrificed. Morphometric analysis was performed using stereomicroscope and ImageJ software. Statistical Analysis Used: Analysis of variance followed by Bonferroni's test, Wilcoxon's test for inter-group comparison, Mann–Whitney test for P value computation was used. The observations are mean ± standard deviation and standard error of the mean. P < 0.01 when compared to control was considered as statistically significant. Results: About 2% curcumin gel showed 42.98% inhibition of edema and peak activity was noted at 24 h. There was statistically significant change in the GI and PPD. Morphometric analysis did not show any significant difference between groups. No toxic effects were seen on oral administration of 2000 mg/kg of curcumin. Conclusions: About 2% curcumin gel was effective in the treatment of experimental periodontitis. PMID:25276071

  6. 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

  7. [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. PMID:27451500

  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. 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. PMID:26889359

  10. 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

  11. Role of contrast-enhanced ultrasonography in percutaneous radiofrequency ablation of liver metastases and efficacy evaluation

    PubMed Central

    Wu, Jie; Yang, Wei; Yin, Shanshan; Wu, Jinyu; Wu, Wei; Yan, Kun

    2013-01-01

    Objective To retrospectively investigate the role of contrast-enhanced ultrasonography (CEUS) in percutaneous radiofrequency ablation (RFA) in patients with liver metastases and evaluate the therapeutic efficacy of RFA assisted by CEUS. Methods From May 2004 to September 2010, 136 patients with 219 liver metastatic lesions received CEUS examination 1 h before RFA (CEUS group), and other 126 patients with 216 lesions without CEUS examination in the earlier period were served as a historical control group. The mean tumor size was 3.2 cm and the mean tumor number was 1.6 in the CEUS group, while 3.4 cm and 1.7 in the control group, respectively (P>0.05). The clinical characteristics, recurrence results and survival outcomes were compared between two groups. Results In the CEUS group, two isoechoic tumors were not demonstrated on unenhanced ultrasonography (US), and 63 (47%) of 134 tumors examined with CEUS were 0.3 cm larger than with unenhanced US. Furthermore, in 18.4% of 136 patients, additional 1-3 tumors were detected on CEUS. The CEUS group showed higher early tumor necrosis and lower intrahepatic recurrence than the control group. The 3-year overall survival (OS) rate and the 3-year local recurrence-free survival (LRFS) rate in the CEUS group were 50.1% and 38.3%, in contrast to 25.3% and 19.3% in the control group, respectively (P=0.002 and P<0.001). Conclusions CEUS provides important information for RFA treatment in patients with liver metastases and better therapeutic effect could be attained. PMID:23592894

  12. Evaluation of the efficacy of 2% Ocimum sanctum gel in the treatment of experimental periodontitis

    PubMed Central

    Hosadurga, Rajesh Ramesh; Rao, Sudarshan Narayan; Edavanputhalath, Rejeesh; Jose, Jobin; Rompicharla, Narayana Charyulu; Shakil, Moidin; Raju, Shashidhara

    2015-01-01

    Introduction: One of the options for the treatment of periodontitis is local drug delivery systems (LDD). Tulsi (Ocimum sanctum), a traditional herb, has many uses in medicine. It could be a suitable agent as LDD for the treatment of periodontitis. Aim: The aim was to formulate, evaluate the anti-inflammatory activity; assess duration of the action and the efficacy of 2% tulsi (O. sanctum) gel in the treatment of experimental periodontitis in Wistar Albino rat model. Settings and Design: Thirty six Wistar albino rats were randomly assigned to 3 groups. Periodontitis was induced using ligature model. Group 1-control; Group 2-Plain gel and Group 3-2% tulsi (O. sanctum) gel. Materials and Methods: 2% tulsi (O. sanctum) gel were prepared. The anti-inflammatory activity and duration of action were assessed. Silk ligature 5-0 was used to induce periodontitis. Gingival index (GI) and probing pocket depth were measured. Treatment was done. The rats were sacrificed. Morphometric analysis was done using Stereomicroscope and ImageJ software. Statistical Analysis Used: ANOVA followed by Bonferroni's test, Wilcoxon's test for intergroup comparison, Mann-Whitney test for P value computation was used. The observations are mean ± standard deviation and standard error of the mean. P < 0.01 as compared to control was considered as statistically significant. Results: 2% tulsi (O. sanctum) gel showed 33.66% inhibition of edema and peak activity was noted at 24 h. There was statistically significant change in the GI and probing pocket depth. Morphometric analysis did not show any significant difference between groups. No toxic effects were seen on oral administration of 2000 mg/kg of Tulsi extract. Conclusions: 2% tulsi (O. sanctum) gel was effective in the treatment of experimental periodontitis. PMID:25599031

  13. Prospective Evaluation of Ultrasonic Surgical Dissectors in Hepatic Resection: A Cooperative Multicenter Study

    PubMed Central

    Millat, Bertrand; Hay, Jean-Marie; Descottes, Bernard; Fagniez, Pierre-Louis

    1992-01-01

    Blood loss is the major cause of postoperative mortality and morbidity associated with hepatic resection. A prospective multicenter study was conducted to determine if ultrasonic dissectors (USD) were useful in hepatic resection and could reduce this hemorrhagic risk. Forty-seven hepatic resections were performed in 42 consecutive patients during a two month period in 11 public, surgical centers. Twenty-one patients had primary or secondary malignancies, six had benign tumors, two had biliary cysts, one had cholangiocarcinoma, one had Caroli’s disease, and 11 had hydatid cysts of the liver. Two different USD devices were evaluated (CUSA System-Lasersonics and NIIC-DX 101 T). The hepatic resections tested included a wide range of procedures. Each surgeon had the possibility of choosing between the USD and his own usual technique for each operative step and according to local conditions. The average volume of blood infused, irrespective of the underlying pathology or the procedure performed, was 1.0 L (range 0-4.8 L). Fourteen patients required no transfusions. No operative or immediate postoperative deaths were recorded. Five major complications, all unrelated to the use of the USD, developed in three patients. Access to intra and extraparenchymal arterial and venous tributaries and particularly the control of the hepatic veins were facilitated by USD. While transection of hepatic parenchyma was neither easier nor faster than with conventional techniques, it was found to be less hemorrhagic. Overall appraisal was expressed on an analog scale; the USD was found to be helpful or very helpful in 75 percent of all resections. With regard to the pathology being treated, total or partial excision of hydatid cysts was greatly enhanced by the use of the USD while this benefit was not found for wedge resections of other hepatic lesions. With regard to user friendliness and maintenance, the NIIC-DX 101 T device was preferred. We conclude that the USD facilitates formal

  14. 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. PMID:26362476

  15. A phase III trial evaluating the efficacy and tolerability of nimesulide 1% spray in patients with soft-tissue injuries

    PubMed Central

    Khan, Mazharuddin Ali; Rao, Madhusudhan; Reddy, Madan M.; Tamloorker, Datta; Gumdal, Vishesh; Latha, Moodahadu S.; Krishnankutty, Binny

    2013-01-01

    Aim: To evaluate the efficacy and safety of nimesulide 1% w/w spray in minor soft-tissue injuries in adult Indians through a multicentric, open-labeled, phase III trial. Materials and Methods: 125 eligible patients, who met the selection criteria and gave written informed consent, were screened, enrolled, and treated with nimesulide 1% spray for seven days. Patients were assessed at baseline, day 1, day 4, and day 8 for efficacy and safety. Primary efficacy variable pain intensity, was measured using a NRS 1-100 mm (numerical rating scale). Secondary efficacy variables were degree of inflammation and edema and degree of functional impairment; overall assessment of efficacy was done by patient (patient global assessment – PGA) and by investigator (investigator global assessment – IGA) on days 4 and 8. Result: There was a statistically significant reduction in the NRS score, degree of pain, edema (inflammation), and improvement in functional impairment on days 4 and 8 and in serum creatine kinase levels on day 8 in comparison with baseline. Global assessment of efficacy on day 8 was rated as “very good (21%),” “good (67.70%),” and “fair (11.30%)” by investigators and “very good (25%),” “good (58.90%),” and “fair (16.1%)” by patients. Two mild adverse events were reported in two patients, which resolved without any intervention. One (local irritation) was reported as not related, while the other (itching sensation) was probably related to the study drug. Conclusion: Nimesulide 1% spray was effective with a good safety profile and can be considered is a good alternative to oral analgesic therapy in minor soft-tissue injuries. PMID:23724380

  16. Evaluation of the efficacy and safety of intravenous ciprofloxacin versus meropenem in the treatment of postoperative infection.

    PubMed

    Kusachi, Shinya; Sumiyama, Yoshinobu; Takahashi, Yoshiki; Kato, Komei; Mashita, Keiji; Takeyama, Hiromitsu; Oda, Shigeto; Kobayashi, Shinichi

    2012-04-01

    Therapeutic options for postoperative infection in gastrointestinal surgery are limited. To identify new treatment alternatives, the Japan Society for Surgical Infection conducted a multicenter prospective, randomized, controlled clinical trial comparing the efficacy of intravenous ciprofloxacin (CIP IV) and intravenous meropenem (MEM IV). Between July 2005 and May 2008, the trial recruited patients who developed postoperative infection or had suspected infectious systemic inflammatory response syndrome after elective clean-contaminated gastrointestinal surgery. All patients had received prophylactic postoperative antibiotic treatment. Patients received either intravenous CIP IV 300 mg b.i.d. or MEM IV 500 mg b.i.d. A total of 205 patients from 31 institutions were enrolled. Of these, 101 were randomized to CIP IV and 104 to MEM IV. There were 100 and 102 in the intent-to-treat (ITT)/safety population and 75 and 77 in the per-protocol (PP) population. There was no significant difference between CIP IV and MEM IV in terms of clinical efficacy, bacteriological efficacy, incidence of adverse drug reactions, duration of antimicrobial treatment, or relapse/reactivation. Overall clinical success PP population) was high in both treatment groups: 85.3% (64/75) for CIP IV and 89.6% (69/77) for MEM IV, although the non-inferiority of CIP IV was not demonstrated (difference -4.3%, 95% CI -14.8, 6.2). In patients who had undergone upper gastrointestinal surgery, success was 88.5% (23/26) for CIP IV and 85.2% (23/27) for MEM IV. Intravenous ciprofloxacin is as effective as intravenous meropenem in the empiric therapy of postoperative infection after gastrointestinal surgery. PMID:22009525

  17. 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

  18. Portfolios: An Effective Tool Used by Prospective Teachers To Encourage Self-Evaluation and Improvement.

    ERIC Educational Resources Information Center

    Morin, Joy Ann

    In an effort to provide prospective teachers with chances to reflect on their professional competence, and to demonstrate their teaching effectiveness and growth, the teacher education program at California State University, Los Angeles, decided to require students to develop portfolios. All students were introduced to the portfolio format during…

  19. A Prospective, Multicenter, Phase I Matched-Comparison Group Trial of Safety, Pharmacokinetics, and Preliminary Efficacy of Riluzole in Patients with Traumatic Spinal Cord Injury

    PubMed Central

    Fehlings, Michael G.; Frankowski, Ralph F.; Burau, Keith D.; Chow, Diana S.L.; Tator, Charles; Teng, Angela; Toups, Elizabeth G.; Harrop, James S.; Aarabi, Bizhan; Shaffrey, Christopher I.; Johnson, Michele M.; Harkema, Susan J.; Boakye, Maxwell; Guest, James D.; Wilson, Jefferson R.

    2014-01-01

    Abstract A prospective, multicenter phase I trial was undertaken by the North American Clinical Trials Network (NACTN) to investigate the pharmacokinetics and safety of, as well as obtain pilot data on, the effects of riluzole on neurological outcome in acute spinal cord injury (SCI). Thirty-six patients, with ASIA impairment grades A–C (28 cervical and 8 thoracic) were enrolled at 6 NACTN sites between April 2010 and June 2011. Patients received 50 mg of riluzole PO/NG twice-daily, within 12 h of SCI, for 14 days. Peak and trough plasma concentrations were quantified on days 3 and 14. Peak plasma concentration (Cmax) and systemic exposure to riluzole varied significantly between patients. On the same dose basis, Cmax did not reach levels comparable to those in patients with amyotrophic lateral sclerosis. Riluzole plasma levels were significantly higher on day 3 than on day 14, resulting from a lower clearance and a smaller volume of distribution on day 3. Rates of medical complications, adverse events, and progression of neurological status were evaluated by comparison with matched patients in the NACTN SCI Registry. Medical complications in riluzole-treated patients occurred with incidences similar to those in patients in the comparison group. Mild-to-moderate increase in liver enzyme and bilirubin levels were found in 14–70% of patients for different enzymes. Three patients had borderline severe elevations of enzymes. No patient had elevated bilirubin on day 14 of administration of riluzole. There were no serious adverse events related to riluzole and no deaths. The mean motor score of 24 cervical injury riluzole-treated patients gained 31.2 points from admission to 90 days, compared to 15.7 points for 26 registry patients, a 15.5-point difference (p=0.021). Patients with cervical injuries treated with riluzole had more-robust conversions of impairment grades to higher grades than the comparison group. PMID:23859435

  20. Evaluation of efficacy and safety of botulinum toxin type A injection in patients requiring temporary tarsorrhaphy to improve corneal epithelial defects

    PubMed Central

    Kasaee, Abolfazl; Musavi, Mohammad Reza; Tabatabaie, Syed Ziaeddin; Hashemian, Mohammad Nasser; Mohebbi, Shahrzad; Khodabandeh, Alireza; Taher Rajabi, Mohammad

    2010-01-01

    AIM To evaluate the efficacy and safety of botulinum toxin type A (Dysport, (Ipsen Biopharm Ltd, Wrexham, UK)) injection in patients requiring temporary tarsorrhaphy to improve corneal epithelial defects. METHODS Thirty patients were enrolled into the prospective study between March 2007 and September 2009. Doses of 15 and 30U of Dysport were injected into the levator palpebrae superioris muscle through the eyelid. The patients were followed daily until completion of ptosis and then 1-2 weekly until complete resolution of levator function and improvement of corneal condition. RESULTS Ptosis took 2.64±1.85 days to be completed (range 1-9 days) and lasted for 12±2.19 weeks. For patients with seventh nerve palsy, 30U Dysport was appropriate to produce sufficient ptosis whereas in other patients 15U of toxin was sufficient. In 83.3% of patients ptosis was sufficient for complete recovery of corneal epithelium and 16.7% required a second procedure (Amniotic membrane transplantation, conjunctival flap). There was a direct correlation between age and duration of ptosis. In patients with seventh nerve palsy, the amount of resultant ptosis was significantly lower than that of other patients. The only adverse effects of injection were superior rectus underaction (33.3%) and diplopia (16.7%) which resolved in all patients without any intervention. CONCLUSION Dysport injection is a safe and effective substitute for surgical tasorrhaphy with fewer complications. PMID:22553562

  1. Evaluation of the efficacy and safety of oral nicardipine in treatment of urgent hypertension: a multicenter, randomized, double-blind, parallel, placebo-controlled clinical trial.

    PubMed

    Habib, G B; Dunbar, L M; Rodrigues, R; Neale, A C; Friday, K J

    1995-05-01

    This study was a prospective, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety and efficacy of oral nicardipine for the treatment of urgent hypertension in the emergency department. Of 57 patients with urgent hypertension 53 patients were enrolled: 36 men and 17 women, 43 black and 10 white, age range 48 +/- 11 years, and diastolic blood pressure 128 +/- 7 mm Hg. Patients were randomly assigned to receive 30 mg nicardipine or placebo in blind fashion followed by 30 mg open-label nicardipine in nonresponders. Responders to one or two doses of nicardipine received 30 or 40 mg nicardipine three times a day for 1 week after discharge from the emergency department. Adequate blood pressure reduction, defined as a reduction of diastolic blood pressure to less than 100 mm Hg or by at least 20 mm Hg, was achieved in 65% and 22% of patients who received 30 mg nicardipine or placebo (p = 0.002). Adequate blood pressure reduction after administration of open-label nicardipine occurred in 76% of the nonresponders to placebo. Blood pressure reductions were maintained at 1 week after discharge. The drug was well tolerated, and no significant adverse events occurred. We conclude that oral nicardipine is a safe and effective drug for the initial treatment of urgent hypertension. PMID:7732981

  2. Evaluation of the efficacy and safety of levalbuterol in subjects with COPD.

    PubMed

    Donohue, James F; Parsey, Merdad V; Andrews, Charles; D'Urzo, Tony; Sharma, Satyendra; Schaefer, Kendyl; Claus, Raymond; Baumgartner, Rudolf A

    2006-08-01

    The efficacy and safety of nebulized levalbuterol in adults with chronic obstructive pulmonary disease (COPD) was evaluated in this multicenter, randomized, double-blind, parallel design study. Randomized subjects (n = 209) received levalbuterol (LEV) 0.63 mg or 1.25 mg, racemic albuterol (RAC) 2.5 mg, or placebo (PBO) TID for 6 weeks. Serial spirometry was completed in-clinic after study drug alone (weeks 0, 2, and 6) or in combination with ipratropium bromide 0.5 mg (week 4). The primary endpoint was the averaged FEV1 AUC(0-8 hrs) over weeks 0, 2 and 6 compared with placebo. Other endpoints included rescue medication use, safety parameters, COPD exacerbations, and global evaluations. All active treatments demonstrated improvements in the percent change in FEV1 AUC(0-8 hrs) over the double-blind period and at each visit vs PBO (p < 0.05). Rescue medication use vs. baseline (doses/day) changed over time: PBO +0.38 +/- 3.3; LEV 0.63 mg +0.07 +/- 3.3; LEV 1.25 mg -0.84 +/- 3.8 (p = 0.02 vs. RAC); RAC +0.97 +/- 2.5. The overall rate of adverse events was PBO 56.4%, LEV 0.63 mg 56.6%, LEV 1.25 mg 67.3%, and RAC 65.4%. Protocol-defined COPD exacerbations occurred in all groups (PBO 12.7%, LEV 0.63 mg 11.3%; LEV 1.25 mg 18.4%; RAC 21.2%). Withdrawals due to COPD exacerbations were significantly higher in the RAC group compared with PBO (PBO 0%; LEV 0.63 mg 1.9%; LEV 1.25 mg 4.1%; RAC 9.6% p = 0.01 vs. PBO). In this study, levalbuterol treatment in subjects with COPD was generally well tolerated, produced significant bronchodilation compared with PBO, and improved clinical control of COPD as evidenced by reductions in rescue medication use compared with PBO and/or RAC. PMID:17240614

  3. Evaluation of Sexual Dimorphism in the Efficacy and Safety of Simvastatin/Atorvastatin Therapy in a Southern Brazilian Cohort

    PubMed Central

    Smiderle, Lisiane; Lima, Luciana O.; Hutz, Mara Helena; der Sand, Cézar Roberto Van; der Sand, Luiz Carlos Van; Ferreira, Maria Elvira Wagner; Pires, Renan Canibal; Almeida, Silvana; Fiegenbaum, Marilu

    2014-01-01

    Background Dyslipidemia is the primary risk factor for cardiovascular disease, and statins have been effective in controlling lipid levels. Sex differences in the pharmacokinetics and pharmacodynamics of statins contribute to interindividual variations in drug efficacy and toxicity. Objective To evaluate the presence of sexual dimorphism in the efficacy and safety of simvastatin/atorvastatin treatment. Methods Lipid levels of 495 patients (331 women and 164 men) were measured at baseline and after 6 ± 3 months of simvastatin/atorvastatin treatment to assess the efficacy and safety profiles of both drugs. Results Women had higher baseline levels of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) compared with men (p < 0.0001). After treatment, women exhibited a greater decrease in plasma TC and LDL-C levels compared with men. After adjustment for covariates, baseline levels of TC and LDL-C influenced more than 30% of the efficacy of lipid-lowering therapy (p < 0.001), regardless of sex. Myalgia [with or without changes in creatine phosphokinase (CPK) levels] occurred more frequently in women (25.9%; p = 0.002), whereas an increase in CPK and/or abnormal liver function was more frequent in in men (17.9%; p = 0.017). Conclusions Our results show that baseline TC and LDL-C levels are the main predictors of simvastatin/atorvastatin therapy efficacy, regardless of sex. In addition, they suggest the presence of sexual dimorphism in the safety of simvastatin/atorvastatin. The effect of sex differences on receptors, transporter proteins, and gene expression pathways needs to be better evaluated and characterized to confirm these observations. PMID:25120083

  4. 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

  5. [Evaluation of the efficacy of colistin/sulbactam combination on carbapenem-resistant Acinetobacter baumannii strains].

    PubMed

    Çetinkol, Yeliz; Telli, Murat; Altunçekiç Yıldırım, Arzu; Çalgın, Mustafa Kerem

    2016-07-01

    (6%) were positive for OXA-24. Among MBLs, OXA-58, OXA-48, IPM, SPM, SIM, GIM, VIM and NDM-1 genes were not detected. In the evaluation of PFGE results it was found that the clonal distribution of the strains, except one, were all pulsotype A. In the assessment of in vitro efficacy of the colistin-sulbactam combination against A.baumannii strains with multidrug resistance, antagonistic effect was observed in all strains. In the resistance and clonal analysis it was determined that the strains belonged to the same clone, and they had the same resistance genes and therefore the result of the in vitro activity was considered to have similar effect among all strains. It was decided that especially in units where critical patients are monitored and where resistant strains that are difficult to treat are isolated, performing synergy studies may be beneficial for the selection of combination treatment and the determination of the treatment combination to be chosen specifically for the hospital or even the unit. PMID:27525401

  6. 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. PMID:26585471

  7. [Evaluation of efficacy and tolerance of amisulpride in treatment of schizophrenic psychoses].

    PubMed

    Chabannes, J P; Pelissolo, A; Farah, S; Gerard, D

    1998-01-01

    Amisulpride is a benzamide derivative atypical antipsychotic characterized by selective blockade of dopamine D3 and D2 receptors, limbic selectivity and preferential blockade of dopamine autoreceptors at low doses. Its efficacy on predominant negative symptoms of schizophrenia at low doses, and on the positive symptoms at doses from 400 to 1,200 mg/day has been demonstrated in several controlled studies. The aim of our study was to assess the use in psychiatric clinical practice under naturalistic conditions, efficacy and safety of amisulpride and patient's ability to cope with social skills during a 3-month period of treatment with a follow-up at 6 months. A total of 445 patients (293 men and 152 women), between 18 and 45 years of age, were included in the study DSM III-R criteria of schizophrenia, paranoid type (295.3), or schizophreniform disorder (295.4) were required for inclusion. The patients received amisulpride with flexible dosage between 600 and 1,200 mg/d during a 3-month period (792 mg/d +/- 318). Evaluation was based on the Brief Psychiatric Rating Scale (BPRS), on the Positive And Negative Symptoms Scale (PANSS), and on Clinical Global Improvement scale, completed at D0, D14, D28, D60 and D90. Safety was also assessed with a comprehensive statement of adverse events and with the Simpson-Angus scale of extra pyramidal symptoms. A scale of social adaptation (Echelle d'Adaptation PsychoSociale) was completed at D0, D90 and D180. During the 3-month period of treatment, 124 patients (27.9%) dropped out the trial, including 24 cases of inefficacy and 27 cases of concomitant events. Intent-to-treat analysis showed a significant improvement of BPRS scores (40.2 vs 67.6; p < 0.0001), of positive PANSS scores (13.9 vs 27.7; p < 0.0001), and negative PANSS scores (17.45 vs 28.3; p < 0.0001) between D0 and D90. CGI results confirmed these figures. Follow-up assessment at D180 showed a sustained response on BPRS ans PANSS scores. Amisulpride was well tolerated in

  8. Evaluation of the efficacy of pyrantel-oxantel for the treatment of soil-transmitted nematode infections.

    PubMed

    Albonico, Marco; Bickle, Quentin; Haji, Hamad J; Ramsan, Mahdi; Khatib, Khatib J; Montresor, Antonio; Savioli, Lorenzo; Taylor, Martin

    2002-01-01

    A randomized controlled trial comparing the efficacy of pyrantel-oxantel (10 mg/kg) with mebendazole (500 mg) was performed on 1329 schoolchildren aged 6-9 years on Pemba Island in September-October 2000 to evaluate alternative single-dose drugs for regular treatment of intestinal nematode infections. Both mebendazole and pyrantel-oxantel were very effective in eliminating Ascaris lumbricoides infection, inducing cure rates of more than 96% and reducing the mean egg counts by more than 95%. Both drugs had a moderate efficacy against Trichuris trichiura infection, but pyrantel-oxantel had a higher cure rate (31.5% vs. 23.3%, P < 0.01), though the reductions in egg counts did not differ significantly and were more than 80%. Pyrantel-oxantel and mebendazole had a similar, poor efficacy in curing hookworm infections and had a moderate effect in reducing the egg counts by 67% and 68%, respectively. Pyrantel-oxantel (10 mg/kg) offers a valuable alternative to mebendazole as a single-dose treatment for the control of intestinal nematode infections in children in endemic areas of sub-Saharan Africa, due to its comparable efficacy, its low cost and its suitability for use in young children. PMID:12625151

  9. The field evaluation of albendazole and triclabendazole efficacy against Fasciola hepatica by coproantigen ELISA in naturally infected sheep.

    PubMed

    Novobilský, Adam; Averpil, Helen Björk; Höglund, Johan

    2012-11-23

    Albendazole (ABZ) has been used for control of ovine fasciolosis in Sweden for several decades. However, increasing prevalence of Fasciola hepatica in Sweden requires attention to diagnostic tools and current control strategies. The coproantigen reduction test (CRT) using commercial Bio-X K201 Fasciola coproantigen ELISA (Bio-X Diagnostics, Jemelle, Belgium) was recently suggested as a novel method for diagnosis of patent F. hepatica infection. The aim of this study was to compare the efficacy of albendazole and triclabendazole (TCBZ) treatment against F. hepatica in naturally infected sheep in south-western Sweden by CRT, and also to evaluate the usefulness of this test as a diagnostic marker for anthelmintic efficacy following treatment with ABZ. Three weeks after housing, 24 serologically positive ewes on a commercial farm in Sweden were randomly allocated into three groups, which were either dewormed with 5mg/kg ABZ, 10mg/ml TCBZ or left untreated. Twenty-six days after initial administration of these anthelmintics, all of the sheep in the ABZ group and untreated control groups were treated with 10mg/kg TCBZ. While TCBZ caused elimination of coproantigen and eggs in faeces 7 days after application, ABZ treatment failed completely. Neither anthelmintic resistance, underdosing, nor lack of efficacy due to the presence of immature flukes can be out ruled as possible causes. Despite some deviations in conformity between coproantigen levels and presence of fluke eggs, the CRT was a useful tool for measuring treatment efficacies. PMID:22818198

  10. 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. PMID:25726136

  11. Evaluation of the Efficacy of ME1111 in the Topical Treatment of Dermatophytosis in a Guinea Pig Model.

    PubMed

    Long, L; Hager, C; Ghannoum, M

    2016-04-01

    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, thein vivoefficacy of ME1111 was compared to that of ciclopirox in the topical treatment of dermatophytosis caused byTrichophyton mentagrophytesusing 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 aPvalue of <0.001). The potent efficacy of ME1111 could be attributed to its properties, such as low keratin binding. PMID:26833160

  12. 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

  13. 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

  14. 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. PMID:17142219

  15. 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. PMID:25474668

  16. 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.

  17. 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

    2016-03-01

    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

  18. Preventive Analgesic Efficacy of Nefopam in Acute and Chronic Pain After Breast Cancer Surgery: A Prospective, Double-Blind, and Randomized Trial.

    PubMed

    Na, Hyo-Seok; Oh, Ah-Young; Koo, Bon-Wook; Lim, Dae-Jin; Ryu, Jung-Hee; Han, Ji-Won

    2016-05-01

    Breast cancer surgery is known to cause severe acute postoperative pain, which can persist for a long time. We administered nefopam preventively to patients undergoing lumpectomy with axillary lymph node dissection or sentinel lymph node biopsy, and evaluated its efficacy on acute and chronic postoperative pain.Enrolled patients were assigned to the nefopam (n = 41) or the control (n = 42) group. Before initiating the operation, 20 mg of nefopam was given to the patients of the nefopam group, and normal saline was used in the control group. Ketorolac was given at the end of surgery, and meloxicam was prescribed in the postoperative period to all patients in both groups. Pain was assessed using a numerical rating scale (NRS), and the rescue analgesic drug was given when the NRS was >5. Implementation of postoperative chemotherapy, radiotherapy (RT), or hormone therapy was evaluated.The NRS of postoperative pain was significantly lower in the nefopam than in the control group in the postanesthetic care unit (4.5 ± 2.2 vs 5.7 ± 1.5, respectively; P = 0.01), at postoperative 6 h (3.0 ± 1.6 vs 4.5 ± 1.3, respectively; P < 0.001), and at postoperative 24 h (3.1 ± 1.1 vs 3.8 ± 1.5, respectively; P = 0.01) with reduced use of rescue analgesic drugs. Significantly fewer patients suffered from chronic postoperative pain in the nefopam than in the control group at postoperative 3 months (36.6% vs 59.5%, P = 0.04). Considering only the cohort without postoperative adjuvant RT, the difference in the proportion of patients reporting chronic pain increased (23.5% in the nefopam group vs 61.5% in the control group, P = 0.04).Preventive nefopam was helpful in reducing the acute postoperative pain, with reduced use of rescue analgesic drugs, and it contributed to reduced occurrence of chronic pain at postoperative 3 months after breast cancer surgery. PMID:27196485

  19. Evaluation of the efficacy and safety of biapenem against pneumonia in the elderly and a study on its pharmacokinetics.

    PubMed

    Karino, Fumi; Deguchi, Naoko; Kanda, Hibiki; Ohe, Miki; Kondo, Keiichi; Tada, Mitsuhiro; Kuraki, Takashige; Nishimura, Nobuhiro; Moriyama, Hidehiko; Ikawa, Kazuro; Morikawa, Norifumi; Isobe, Takeshi

    2013-02-01

    Although biapenem is used in the treatment of pneumonia, the clinical data on elderly patients are yet insufficient. Therefore, the purpose of this study was evaluating the efficacy and safety of biapenem against pneumonia in the elderly and its pharmacokinetics. The subjects were patients 65 years of age or older with pneumonia. Biapenem (300 mg) was administered once to three times per day. For some cases, the drug concentrations in plasma were measured chronologically. The clinical efficacy was evaluated in reference to the improvement in subjective symptoms and objective opinion. The primary outcome was efficacy rate at the end of treatment. Biapenem was effective in 17 of 20 subject cases (85.0 %). Regarding safety, although 4 cases experienced hepatic dysfunction and 1 case had nausea, these effects were not severe in all cases and administration was continued. There was no deterioration of renal function associated with biapenem. In 13 cases in which the trough value of biapenem was measured, there were no unacceptable side effects and the trough values were generally low. It is believed that biapenem (300 mg once to three times a day), even when taken by elderly people, does not accumulate and that the dosage is safe and appropriate. The changes in the predicted concentrations calculated with the pharmacokinetic-pharmacodynamic (PK-PD) software, which is based on previously reported population pharmacokinetic parameters, and those in the measured concentrations approximately matched. It is useful to plan biapenem administration using the PK-PD software when performing antibiotic chemical treatment. PMID:22926665

  20. Evaluating the Turkish Version of the Discipline Efficacy Scale (DES): Translation Adequacy and Factor Structure

    ERIC Educational Resources Information Center

    Kurt, Hakan; Ekici, Gulay

    2013-01-01

    The aim of this study is to adapt the discipline efficacy scale to Turkish language, and conduct the validity and reliability analysis of the adapted scale. The scale was applied to 157 teacher candidates. Exploratory and confirmatory factor analyses were conducted to reveal the construct validity of the scale. The results of the exploratory…

  1. 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...

  2. 21 CFR 201.200 - Disclosure of drug efficacy study evaluations in labeling and advertising.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) The National Academy of Sciences—National Research Council, Drug Efficacy Study Group, has completed... Commissioner of Food and Drugs from the National Academy of Sciences (1969).” As the report notes, this review... as other than “effective” by a panel of the National Academy of Sciences—National Research...

  3. 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. PMID:26613861

  4. Efficacy, Outcomes, and Empowerment Evaluation of a School District NET Project, Part III: Theoretical Model.

    ERIC Educational Resources Information Center

    Miller-Whitehead, Marie; Abbott, Gypsy

    The efficacy and outcomes of a U.S. Department of Agriculture Nutrition Education Training (NET) project designed to increase awareness of health risk and wellness factors for grade 9 students were studied. This paper comments on results from a survey of 125 ninth graders about the NET curriculum and results from a study of program impact on…

  5. 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.…

  6. Efficacy, Outcomes, and Empowerment Evaluation of a School District NET Project. Research Brief.

    ERIC Educational Resources Information Center

    Miller-Whitehead, Marie

    This study addressed the efficacy and outcomes of a U.S. Department of Agriculture Nutrition Education Training (NET) project designed to increase awareness of health risk and wellness factors for grade 9 high school students. The study also considered the empowerment fostered by the program and measured changes in the health and nutrition…

  7. Evaluating Sixth Graders' Self-Efficacy in Response to the Use of Educational Technology

    ERIC Educational Resources Information Center

    Castagnaro, Anne V.

    2012-01-01

    Sixth grade is a pivotal time in school, as students culminate their elementary school years and anticipate junior high school. At this age, students become more involved in trends, especially technological trends. When students can utilize the same type of technology inside and outside of school, their self-efficacy may increase. Hypothetically,…

  8. 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…

  9. 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...

  10. Efficacy of two low-dose oral tylosin regimens in controlling the relapse of diarrhea in dogs with tylosin-responsive diarrhea: a prospective, single-blinded, two-arm parallel, clinical field trial

    PubMed Central

    2014-01-01

    Background Despite its wide acceptance as a treatment for canine chronic enteropathies, the macrolide antibiotic tylosin lacks official oral dosage recommendations. Not even textbooks share consensus about the dose; daily recommendations vary from 25 to 80 mg/kg and dosing intervals from one to three times daily. The objective of this prospective, single-blinded, two-arm parallel, clinical field trial was to determine whether doses of 5 mg/kg or 15 mg/kg tylosin administered orally once daily for seven days would have a similar effect on fecal consistency in diarrhea relapses to that of a 25 mg/kg dose of tylosin administered once daily for seven days, a dosage that has proved effective in controlling canine tylosin-responsive diarrhea (TRD). A further objective was to compare the efficacy of the 5 mg/kg and 15 mg/kg tylosin dosages. Fifteen client-owned dogs diagnosed with TRD that had responded to a dose of 25 mg/kg tylosin once daily for seven days were enrolled in the study. After a relapse of diarrhea the dogs were allocated into two groups receiving tylosin orally in doses of either 5 mg/kg or 15 mg/kg once daily for seven days. The owners were blinded to the dosage. The elimination of diarrhea was the main criterion in assessing treatment success. The mean fecal consistency score of the last three treatment days for all dosages, including 25 mg/kg, as evaluated by the owners according to a standardized fecal scoring system, served as the primary outcome measures. Results All eight dogs responded to the 5 mg/kg dose, and six of seven dogs responded to the 15 mg/kg dose. The mean fecal consistency scores at the 25 mg/kg tylosin dosage were no significantly different from scores at the 5 mg/kg or 15 mg/kg tylosin dosages (P = 0.672, P = 0.345). Conclusions Interestingly, 14/15 (93%) of the dogs responding to a dose of 25 mg/kg tylosin once daily for seven days also responded to the lower dosages at diarrhea relapse. The data indicate

  11. 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.

  12. 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

  13. A novel bioassay for evaluating the efficacy of biocides to inhibit settling and early establishment of marine biofilms.

    PubMed

    Arrhenius, Åsa; Backhaus, Thomas; Hilvarsson, Annelie; Wendt, Ida; Zgrundo, Aleksandra; Blanck, Hans

    2014-10-15

    This paper presents a novel assay that allows a quick and robust assessment of the effects of biocides on the initial settling and establishment of marine photoautotrophic biofilms including the multitude of indigenous fouling organisms. Briefly, biofilms are established in the field, sampled, comminuted and re-settled on clean surfaces, after 72h chlorophyll a is measured as an integrating endpoint to reflect both settling and growth. Eight antifoulants were used to evaluate the assay. Efficacy ranking, based on EC98 values from most to least efficacious compound is: copper pyrithione>TPBP>DCOIT>tolylfluanid>zinc pyrithione>medetomidine>copper (Cu(2+)), while ecotoxicological ranking (based on EC10 values) is irgarol, copper pyrithione>zinc pyrithione>TPBP>tolylfluanid>DCOIT>copper (Cu(2+))>medetomidine. The algaecide irgarol did not cause full inhibition. Instead the inhibition leveled out at 95% effect at 30 nmoll(-)(1), a concentration that was clearly lower than for any other of the tested biocides. PMID:25150894

  14. 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.

  15. 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. PMID:26056063

  16. In vitro and in vivo evaluation of potassium permanganate treatment efficacy for the control of acute experimental infection of flavobacterium columnare in channel catfish

    Technology Transfer Automated Retrieval System (TEKTRAN)

    An experimental trial was performed to evaluate the efficacy of potassium permanganate against an acute and systemic experimental infection of Flavobacterium columnare in channel catfish, Ictalurus punctatus. The infection was produced by waterborne exposure to the bacteria after mechanical cutaneo...

  17. Importance of Diffusion Weighted Magnetic Resonance Imaging in Evaluation of the Treatment Efficacy in Multiple Sclerosis Patients with Acute Attacks

    PubMed Central

    Sahin, Tuna; Bozgeyik, Zülküf; Menzilcioglu, Mehmet Sait; Citil, Serdal; Erbay, Mehmet Fatih

    2015-01-01

    Summary Background We planned to investigate contribution of DWMR to the treatment efficacy with ADC values which were measured in acute and chronic plaque before and after MS treatment. ADC changes in normal appearing white matter (NAWM) in patients with MS and healthy volunteers were also evaluated in this study. Material/Methods 25 patients with MS and 30 healthy subjects with normal brain MR findings were included to our study. Contrast enhancement in plaque was evaluated as an acute, and non-contrast enhancement in plaque was evaluated as a chronic. Also, ADC measurements were performed using the same parameters in NAWM in plaque neighborhood and volunteers. Results were compared with appropriate statistical methods. Results ADC values in acute and chronic plaques were decreased after the treatment, and these reductions were statistically significant for acute plaqus in b500 and for chronic plaques in b500 and b1000. The mean ADC values were measured as 1.53±0.49×10−3 and 1.43±0.58×10−3 in acute plaques and 1.40±0.35×10−3 and 1.34±0.36×10−3 mm2/sec in chronic plaques before and after the treatment. Conclusions We think that DWMR have important role due to quantitative measurement ability in the evaluation of the treatment efficacy of the MS patients with acute attack in addition to contrast-enhanced MR sequence. PMID:26740826

  18. Efficacy of Adjunctive Subconjunctival Bevacizumab on the Outcomes of Primary Trabeculectomy With Mitomycin C: A Prospective Randomized Placebo-controlled Trial

    PubMed Central

    Orapiriyakul, Lachaya; Kittigoonpaisan, Kaneungnit; Tantisarasart, Thawat; Wangsupadilok, Boonchai

    2015-01-01

    Purpose: To evaluate the efficacy of subconjunctival bevacizumab (ScB) as adjuvant therapy to primary trabeculectomy with mitomycin C (MMC) in primary open-angle glaucoma. Materials and Methods: Forty-six eyes of primary open-angle glaucoma patients were randomized to receive ScB (1.25 mg/0.05 mL) injections (the MMC+ScB group) at the end of the operations, or sham-treated controls (the MMC group). Intraocular pressure (IOP) was the primary outcome and secondary outcomes included bleb appearance, visual acuity, number of medications, complications, and proportion of eyes achieving successful outcomes at the 12-month follow-up. Results: Of 39 eyes, 20 eyes from the MMC+ScB group, and 19 eyes from the MMC group completed the follow-up. The mean postoperative IOP was 15.5±4.1 mm Hg in the MMC+ScB group (P<0.01; 40% reduction), and 14.7±4.3 mm Hg in the MMC group (P<0.01; 44% reduction). The differences in IOPs, at all follow-up visits, were not significant (P>0.05). The mean bleb vascularity score, at 1 month, in the MMC+ScB group was lower than the MMC group (1.55±0.51 vs. 2.26±0.6, respectively, P=0.01), but was not retained at follow-ups. The success rates at 12 months after surgery were 85% in the MMC+ScB group and 89.5% in the MMC group (P=0.53). The cumulative probabilities of surgical success were 80% and 73.7% in the MMC+ScB and in the MMC group, respectively (P=0.52). Conclusion: Single adjunctive ScB injection did not appear to have an additive benefit on outcomes of MMC trabeculectomy, in terms of IOPs and success rates. PMID:25393038

  19. Prospective, randomized, and active controlled study of the efficacy of alginic acid and antacid in the treatment of patients with endoscopy-negative reflux disease

    PubMed Central

    Lai, I-Rue; Wu, Ming-Shiang; Lin, Jaw-Town

    2006-01-01

    AIM: To assess the efficacy and safety of a compound containing alginic acid plus antacid (Topaal®) compared to equal-strength antacid (Nacid®) in patients with endoscopy-negative reflux disease (ENRD). METHODS: A total of 121 patients with ENRD were randomized to receive Topaal® (65 patients) or Nacid® (56 patients) for 6 weeks, with a consultation every 3 weeks. The primary end-point assessment was the change in the severity of heartburn as evaluated using a visual analog scale (VAS) at 6 weeks. The secondary end-point assessments were the VAS at 3 weeks, the change of frequency of the reflux symptom, the change of quality of life and the adverse effects. RESULTS: Demographics of randomized subjects in each treatment group were comparable except that the Topaal® group included more males. The baseline characteristics between the groups were similar. After 6 weeks of treatment, the reduction of VAS of heartburn was more prominent in the Topaal® group (-6.29 cm vs -4.11 cm). At the 3rd week, Topaal® group showed greater reduction of VAS for heartburn (P = 0.0016), regurgitation (P = 0.0006), vomiting (P  = 0.0373), and belching (P  <0.0001). The patients of the Topaal® group had lower frequency of heartburn (P  = 0.0015) and pain (P   = 0.0163) at the end of the 6-week treatment period. From the doctor’s point of view, the Topaal® group also showed significant reduction in the severity of heartburn (P   = 0.0020), regurgitation (P   = 0.0081), vomiting (P  = 0.0182), and belching (P   = 0.0018) at the end of the treatment. The improvement of the quality of life was more remarkable in the Topaal® group at the end of the 6-week treatment period (P  < 0.0001). For the adverse effect, there was no difference in both the groups. CONCLUSION: Topaal® is more effective than Nacid® for the treatment of symptoms presented by patients with ENRD. PMID:16521188

  20. 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

  1. Efficacy of combination therapy for systolic blood pressure in patients with severe systolic hypertension: the Systolic Evaluation of Lotrel Efficacy and Comparative Therapies (SELECT) study.

    PubMed

    Neutel, Joel M; Smith, David H G; Weber, Michael A; Schofield, Lesley; Purkayastha, Das; Gatlin, Marjorie

    2005-11-01

    Systolic hypertension is predominant among patients over 50 years of age, is a more important cardiovascular risk factor than diastolic blood pressure, and is more difficult to control than diastolic blood pressure. Consequently, the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) recommends combination therapy as first-line treatment for patients with stage 2 hypertension. In the Systolic Evaluation of Lotrel Efficacy and Comparative Therapies (SELECT) study, 24-hour ambulatory blood pressure monitoring was used to identify patients with systolic hypertension and to determine the impact of 8 weeks of treatment with either amlodipine besylate/benazepril HCl 5/20 mg combination therapy (n=149), amlodipine besylate 5 mg (n=146), or benazepril HCl 20 mg (n=148). Combination therapy was significantly more effective in reducing systolic blood pressure and pulse pressure than either monotherapy (p<0.0001). Significantly greater percentages of patients in the combination group compared with either monotherapy achieved blood pressure control (p<0.0001). Adverse events were low in all three treatment arms, with less peripheral edema in the combination group than in the amlodipine-treated group. The combination of amlodipine besylate/benazepril HCl given to patients with stage 2 systolic hypertension resulted in significantly greater reductions in blood pressure and pulse pressure than those seen with monotherapy and was at least as well tolerated as the separate components. This data supports the recommendation of the JNC 7 for the use of combination therapy in patients with stage 2 hypertension. PMID:16278521

  2. Retrospective survey to evaluate the safety and efficacy of Japanese botulinum antitoxin therapy in Japan.

    PubMed

    Mottate, Keita; Yokote, Hiroyuki; Mori, Shigemi; Horita, Akira; Miyatsu, Yoshinobu; Torii, Yasushi; Kozaki, Shunji; Iwaki, Masaaki; Takahashi, Motohide; Ginnaga, Akihiro

    2016-02-01

    Japanese botulinum antitoxins have been used for more than 50 years; however, their safety and therapeutic efficacy are not clear. In order to analyze the available data on botulinum antitoxin therapy in Japan, we surveyed published reports about botulism cases in which botulinum antitoxins were used, and retrospectively analyzed the safety and efficacy of the therapy. A total of 134 patients administered botulinum antitoxins were identified from published reports. Two cases of side effects (1.5%) were detected after antitoxin administration, both not fatal. The fatality rate was 9.4%, and more than 70% of the patients showed improvement in their symptoms and better clinical conditions than those not treated with antitoxins. These data suggest that the therapy with Japanese antitoxins is safe and highly effective. PMID:26615088

  3. Efficacy evaluation of some antibiotics against syrian brucella spp isolates, in vitro

    PubMed Central

    Safi, Mazen; Al-Mariri, Ayman

    2012-01-01

    Brucellosis is an endemic zoonosis in Syria, affecting large numbers of animals and there are an increasing number of cases in humans. The aim of this study is to investigate the in vitro efficacy of various traditional and new antibiotics against 89 Brucella isolates (isolated from domestic animals) collected from different Syrian regions. Minimum inhibitory concentrations (MICs) of seventeen antibiotics were determined. Ciprofloxacin and ofloxacin were the most effective antibiotics, whereas sparfloxacin, levofloxacin, doxycycline and tetracycline had a moderate activity. In contrast, moxifloxacin and rifampicin had a low activity, while streptomycin, spiramycin and cephalosporines were ineffective. As a result, we come to the conclusion that a combination between one effective quinolone and doxycycline has a good efficacy against Brucella. Further in vivo studies are necessary to support this suggestion. PMID:24031952

  4. Primary pneumonic plague in the African Green monkey as a model for treatment efficacy evaluation

    PubMed Central

    Layton, R. Colby; Brasel, Trevor; Gigliotti, Andrew; Barr, Edward; Storch, Steven; Myers, Leslie; Hobbs, Charles; Koster, Frederick

    2010-01-01

    Background Primary pneumonic plague is rare among humans but treatment efficacy may be tested in appropriate animal models under the FDA ‘Animal Rule’. Methods Ten African Green monkeys (AGM) inhaled 44 to 255 LD50 doses of aerosolized Y. pestis strain CO92. Continuous telemetry, arterial blood gases, chest radiography, blood culture, and clinical pathology monitored disease progression. Results Onset of fever, >39°C detected by continuous telemetry, 52 to 80 h post-exposure Was the first sign of systemic disease and provides a distinct signal for treatment initiation. Secondary endpoints of disease severity include tachypnea, measured by telemetry, bacteremia, extent of pneumonia imaged by chest x-ray, and serum lactate dehydrogenase enzyme levels. Conclusions Inhaled Y. pestis in the AGM results in a rapidly progressive and uniformly fatal disease with fever and multifocal pneumonia, serving as a rigorous test model for antibiotic efficacy studies. PMID:20722770

  5. Evaluation of the efficacy and safety of sobrerol granules in patients suffering from chronic rhinosinusitis.

    PubMed

    Bellussi, L; Manini, G; Buccella, M G; Cacchi, R

    1990-01-01

    In a double-blind, randomized, placebo-controlled clinical trial, the safety and efficacy of 900 mg/day sobrerol granules given for up to 10 days was assessed in 40 patients with chronic catarrhal rhinosinusitis. At the beginning of treatment a total of six patients had a fever, whereas body temperature was normal in all patients at the end of the treatment. Treatment with sobrerol significantly (P less than 0.01) reduced frontal headache and rhinorrhoea, efficacy being confirmed by rhinomanometry. Patients treated with placebo experienced an improvement in frontal headache, rhinorrhoea,and overall rhinomanometry scores. Treatment with sobrerol was well tolerated but two patients treated with placebo reported adverse reactions (stomach pain and cutaneous rash). These preliminary data suggest that sobrerol could be useful if administered with an anti-inflammatory drug for the treatment of chronic catarrhal rhinosinusitis. PMID:2292326

  6. The burden of research on trauma for respondents: a prospective and comparative study on respondents evaluations and predictors.

    PubMed

    van der Velden, Peter G; Bosmans, Mark W G; Scherpenzeel, Annette C

    2013-01-01

    The possible burden of participating in trauma research is an important topic for Ethical Committees (EC's), Review Boards (RB's) and researchers. However, to what extent research on trauma is more burdensome than non-trauma research is unknown. Little is known about which factors explain respondents evaluations on the burden: to what extent are they trauma-related or dependent on other factors such as personality and how respondents evaluate research in general? Data of a large probability based multi-wave internet panel, with surveys on politics and values, personality and health in 2009 and 2011, and a survey on trauma in 2012 provided the unique opportunity to address these questions. Results among respondents confronted with these events in the past 2 years (N = 950) showed that questions on trauma were significantly and systematically evaluated as less pleasant (enjoyed less), more difficult, but also stimulated respondents to think about things more than almost all previous non-trauma surveys. Yet, the computed effect sizes indicated that the differences were (very) small and often meaningless. No differences were found between users and non-users of mental services, in contrast to posttraumatic stress symptoms. Evaluations of the burden of previous surveys in 2011 on politics and values, personality and health most strongly, systematically and independently predicted the burden of questions on trauma, and not posttraumatic stress symptoms, event-related coping self-efficacy and personality factors. For instance, multiple linear regression analyses showed that 30% of the variance of how (un)pleasant questions on trauma and life-events were evaluated, was explained by how (un)pleasant the 3 surveys in 2011 were evaluated, in contrast to posttraumatic stress symptoms (not significant) and coping self-efficacy (5%). Findings question why EC's, RB's and researchers should be more critical of the possible burden of trauma research than of the possible burden of

  7. An evaluation of choice on instructional efficacy and individual preferences among children with autism.

    PubMed

    Toussaint, Karen A; Kodak, Tiffany; Vladescu, Jason C

    2016-03-01

    The current study compared the differential effects of choice and no-choice reinforcement conditions on skill acquisition. In addition, we assessed preference for choice-making opportunities with 3 children with autism, using a modified concurrent-chains procedure. We replicated the experiment with 2 participants. The results indicated that choice-making opportunities increased treatment efficacy for 2 of the 3 participants, and all 3 participants demonstrated a preference for choice-making opportunities. PMID:26510978

  8. Evaluating the efficacy of therapeutic HIV vaccines through analytical treatment interruptions

    PubMed Central

    Graziani, Gina M; Angel, Jonathan B

    2015-01-01

    Introduction The development of an effective therapeutic HIV vaccine that induces immunologic control of viral replication, thereby eliminating or reducing the need for antiretroviral therapy (ART), would be of great value. Besides the obvious challenges of developing a therapeutic vaccine that would generate effective, sustained anti-HIV immunity in infected individuals is the issue of how to best assess the efficacy of vaccine candidates. Discussion This review discusses the various outcome measures assessed in therapeutic HIV vaccine clinical trials involving individuals receiving suppressive ART, with a particular focus on the role of analytical treatment interruption (ATI) as a way to assess the virologic control induced by an immunotherapy. This strategy is critical given that there are otherwise no readily available measures to determine the ability of a vaccine-induced immune response to effectively control HIV replication. The various outcome measures that have been used to assess vaccine efficacy in published therapeutic HIV vaccine clinical trials will also be discussed. Outcome measures have included the kinetics of viral rebound, the new viral set point and changes in the size of the viral reservoir. Clinically relevant outcomes such as the CD4 decline, the time to resume therapy or the time to meet the criterion to resume therapy, the proportion of participants who resume therapy and/or the development of clinical symptoms such as acute retroviral syndrome are also measures of vaccine efficacy. Conclusions Given the lack of consistency between therapeutic HIV vaccine trials in how efficacy is assessed, comparing vaccines has been difficult. It would, therefore, be beneficial to determine the most clinically relevant measure for use in future studies. Other recommendations for future clinical trials also include studying compartments in addition to blood and replacing ATIs with single-copy assays in situations in which the use of an ATI is not ideal

  9. Efficacy and toxicity evaluation of new amphotericin B micelle systems for brain fungal infections.

    PubMed

    Moreno-Rodríguez, Ana C; Torrado-Durán, Susana; Molero, G; García-Rodríguez, Juan José; Torrado-Santiago, Santiago

    2015-10-15

    The aim of this work is to study the micelle systems of amphotericin B (AmB) and surfactant sodium deoxycholate (NaDC) as possible formulations to treat brain fungal infections. Fungizone(®) and Ambisome(®) were used as AmB references. The particle size, aggregation state, toxicity and efficacy of AmB:NaDC micelles were studied with increasing proportions of NaDC. Differences in the size and aggregation state of the reference formulations and micellar NaDC formulations might explain the differences in their distribution and therefore in their toxicity and efficacy. AmB:NaDC 1:0.8 and 1:1.5 nano-sized micelle systems showed a poly-aggregated form of AmB and small mean particle size (450-750 nm). The AmB:NaDC 1:0.8 and AmB:NaDC 1:1.5 micelle systems studied showed an 8-fold lower toxicity than Fungizone(®). Efficacy was examined in a murine candidiasis model by determining the survival rate and tissue burden reduction in kidneys and brain. The AmB:NaDC 1:1.5 micellar system at 5mg/kg of AmB and the highest amount of NaDC (7.5 mg/kg) presented a good survival rate, and induced a major clearance of brain infection. The new AmB:NaDC 1:1.5 nano-sized micelle system is a promising formulation with a good efficacy/toxicity ratio, which can be attributed to its particle size, AmB aggregation state and NaDC content. PMID:26256151

  10. Examination of the Self-Efficacy Beliefs of Prospective Chemistry Teachers in Terms of Different Variables (the Sample of Dokuz Eylul University)

    ERIC Educational Resources Information Center

    Akkuzu, Nalan; Akcay, Husamettin

    2012-01-01

    This research was conducted to adapt the chemistry self efficacy belief (CSEB) scale using Confirmatory Factor Analysis (CFI) and to examine pre service teachers' CSEB in terms of some demographic features. This descriptive study was carried out Dokuz Eylul University in 2008-2010 academic years. Firstly, for validity and reliability, the scale…

  11. Field evaluation of the efficacy of fenbendazole in captive wild ruminants.

    PubMed

    Goossens, E; Dorny, P; Vercammen, F; Vercruysse, J

    2005-11-01

    The efficacy of in-feed fenbendazole at a dose rate of 7.5 mg/kg bodyweight for three consecutive days was assessed in five Arabian oryx (Oryx leucoryx), six scimitar-horned oryx (Oryx dammah), 14 slender-horned gazelles (Gazella leptoceros), eight Soay sheep (Ovis aries aries soay), 13 alpine ibex (Capra ibex ibex), six red deer (Cervus elaphus hippelaphus) and 11 Nelson's elk (Cervus elaphus nelsoni) kept in five herds in a zoo. The efficacy was assessed by means of repeated faecal egg count reduction (fecr) tests and in vitro egg hatch assays. Fenbendazole was highly effective against nematodes in five of the seven species, consistently reducing egg shedding by more than 90 per cent. In the egg hatch assays of the five herds, 50 per cent inhibition of hatching (ld50) was observed at a concentration of thiabendazole below 0.1 microg/ml. In the Arabian oryx and alpine ibex the efficacy of fenbendazole was less than 90 per cent, and the ld50 in the egg hatch assays was between 0.1 and 0.2 microg/ml thiabendazole. PMID:16272545

  12. 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

  13. A prospective evaluation of the transthyretin Ile122 allele frequency in an African-American population.

    PubMed

    Yamashita, Taro; Hamidi Asl, Kamran; Yazaki, Masahide; Benson, Merrill D

    2005-06-01

    Transthyretin Val122Ile is one of greater than 80 mutations in transthyretin (TTR) that are associated with hereditary amyloidosis. Retrospective studies have shown a prevalence of this mutation as high as 3.9% in African-Americans. The present study was undertaken to determine in a prospective fashion the prevalence of the TTR Val122Ile allele in African-Americans in a Midwestern American city. DNA was isolated from cord bloods collected at the time of birth in the County hospital of Indianapolis, Indiana. Samples were identified only as to ethnic origin of the mother. Analysis was performed by PCR amplification of TTR exon 4 followed by SSCP and RFLP. Cord bloods from 1,973 children born at the County hospital were analyzed. Thirty of 1,000 DNA samples from African-American newborns were positive for TTR Val122Ile (3%). Two of 453 DNA samples from Caucasian newborns were positive (0.44%). Zero of 490 DNA samples from newborns of Hispanic mothers and 0 of 30 from newborns with mothers classified as other (including Asian) were positive. This prospective study demonstrates that 3% of newborns of African-American women in an urban population have the TTR Val122Ile mutation which is associated with late-onset cardiomyopathy. The degree of penetrance of this mutation at the clinical level has not yet been determined. PMID:16011990

  14. Evaluation of changes induced by temperature, contact time, and surface in the efficacies of disinfectants against avian influenza virus.

    PubMed

    Jang, Yangho; Lee, Joongbok; So, Byungjae; Lee, Kwangjick; Yun, Seonjong; Lee, Myoungheon; Choe, Nonghoon

    2014-01-01

    Avian influenza viruses (AIV) are highly susceptible to all disinfectants because they are enveloped viruses. Disinfectants effective against AIV have optimum efficacies at temperatures above 20°C. Very few studies on effective disinfectants at low temperatures have been done. Disinfectants were investigated at 4 different temperatures (25, 4, 0, and -10°C) and 2 contact times (1 and 5 min) with suspension tests. Virucidal activity of the disinfectants was evaluated by carrier tests (wood and stainless steel) at 25 and -10°C. The concentration of each disinfectant for efficient disinfection within a short time (<1 min) at 25 and -10°C was also reestablished. The results from the suspension test indicated that low temperatures inhibited the virucidal efficacy of citric acid (CA) and CA + quaternary ammonium compounds (CA+ QAC) for 1 and 5 min, whereas the remaining disinfectants were effective, regardless of the short contact times and low temperatures. The carrier test results suggested that dried virus on wood was more difficult to inactivate compared with that on stainless steel. However, sodium dichloroisocyanurate and glutaraldehyde could inactivate AIV on both wood and stainless steel at -10°C. Citric acid-based agents could not sufficiently inactivate AIV at -10°C; however, the limitation due to low temperatures was overcome by adjusting disinfectant concentration. For a successful disinfection during winter, the disinfectants that could have short contact times with optimum efficacy against the target organism should be selected. PMID:24570425

  15. Therapeutic efficacy evaluation of 111in-VNB-liposome on human colorectal adenocarcinoma HT-29/ luc mouse xenografts

    NASA Astrophysics Data System (ADS)

    Lee, Wan-Chi; Hwang, Jeng-Jong; Tseng, Yun-Long; Wang, Hsin-Ell; Chang, Ya-Fang; Lu, Yi-Ching; Ting, Gann; Whang-Peng, Jaqueline; Wang, Shyh-Jen

    2006-12-01

    The purpose of this study is to evaluate the therapeutic efficacy of the liposome encaged with vinorelbine (VNB) and 111In-oxine on human colorectal adenocarcinoma (HT-29) using HT-29/ luc mouse xenografts. HT-29 cells stably transfected with plasmid vectors containing luciferase gene ( luc) were transplanted subcutaneously into the male NOD/SCID mice. Biodistribution of the drug was performed when tumor size reached 500-600 mm 3. The uptakes of 111In-VNB-liposome in tumor and normal tissues/organs at various time points postinjection were assayed. Multimodalities, including gamma scintigraphy, bioluminescence imaging (BLI) and whole-body autoradiography (WBAR), were applied for evaluating the therapeutic efficacy when tumor size was about 100 mm 3. The tumor/blood ratios of 111In-VNB-liposome were 0.044, 0.058, 2.690, 20.628 and 24.327, respectively, at 1, 4, 24, 48 and 72 h postinjection. Gamma scinitigraphy showed that the tumor/muscle ratios were 2.04, 2.25 and 4.39, respectively, at 0, 5 and 10 mg/kg VNB. BLI showed that significant tumor control was achieved in the group of 10 mg/kg VNB ( 111In-VNB-liposome). WBAR also confirmed this result. In this study, we have demonstrated a non-invasive imaging technique with a luciferase reporter gene and BLI for evaluation of tumor treatment efficacy in vivo. The SCID mice bearing HT-29/ luc xenografts treated with 111In-VNB-liposome were shown with tumor reduction by this technique.

  16. Clinical efficacy and scintigraphic evaluation of post-coronary bypass patients undergoing percutaneous transluminal coronary angioplasty for recurrent angina pectoris

    SciTech Connect

    Reed, D.C.; Beller, G.A.; Nygaard, T.W.; Tedesco, C.; Watson, D.D.; Burwell, L.R.

    1989-01-01

    The efficacy of percutaneous transluminal angioplasty in improving recurrent anginal symptoms and myocardial perfusion after coronary artery bypass graft surgery was assessed prospectively in 55 patients, of whom 50 had an initial angiographic and clinical success. Although 80% of those successfully dilated were initially free of angina at 23 +/- 11 months of follow-up, one half of these patients had recurrent angina. Although only 48% of the patient cohort had complete relief of angina, 94% had less angina than before dilatation and 86% were able to decrease antianginal medications. Fifteen patients with persistent or recurrent angina had from one to five repeat dilatations. After angioplasty, lung thallium uptake, the extent of abnormal scan segments, and the magnitude of redistribution in dilated lesions were significantly reduced (n = 24 patients). Redistribution defects were seen in 38% of patients on postangioplasty scans. All were associated with subsequent angina. Of various clinical, angiographic, exercise, and thallium-201 scan variables, only the presence of delayed redistribution was an independent predictor of recurrent angina. Restenosis was the most common underlying cause for this exercise-induced perfusion defect. Thus percutaneous coronary angioplasty performed as primary therapy for recurrent angina after bypass surgery is moderately successful in long-term follow-up for the amelioration of symptoms and enhancement of regional myocardial perfusion.

  17. Over-the-counter fish oil use in a county hospital: Medication use evaluation and efficacy analysis

    PubMed Central

    Tatachar, Amulya; Pio, Margaret; Yeung, Denise; Moss, Elizabeth; Chow, Diem; Boatright, Steven; Quinones, Marissa; Mathew, Annie; Hulstein, Jeffrey; Adams-Huet, Beverley; Ahmad, Zahid

    2016-01-01

    BACKGROUND Little is known about the use and effectiveness of over-the-counter (OTC) fish oil supplements for triglyceride (TG) lowering. OBJECTIVES To (1) perform a medication-use evaluation (MUE) and (2) assess the efficacy of OTC fish oil. METHODS Retrospective, observational cohort study using electronic medical records and the pharmacy database from Parkland Health and Hospital System in Dallas, Texas. Parkland is a tax-supported county institution that provides patients with single-brand OTC fish oil. Two separate analyses were conducted. Six hundred seventeen patients (prescribed fish oil between July 1, 2012, and August 31, 2012) were included in the MUE analysis and 235 patients (109 fish oil, 72 fenofibrate, and 54 gemfibrozil, prescribed between January 1, 2012, and July 31, 2013) were included in the efficacy analysis. The main outcome measure for the MUE was fish oil prescribing habits including dosages and patient adherence, as defined by medication possession ratio. The main outcome measure for the efficacy analysis was change in lipids measured using the last value before fish oil treatment and the first value after fish oil treatment. RESULTS MUE: 617 patients received prescriptions for OTC fish oil. Sixty-four percent were prescribed a total daily dose of 2000 mg. Only 25% of patients were adherent. Efficacy analysis: despite being prescribed suboptimal doses, fish oil reduced TGs by 29% (95% confidence interval, 34.3–22.7). Compared with fish oil therapy, fibrate therapy resulted in a greater TG reduction: 48.5% (55.1–41.0) with fenofibrate and 49.8% (57.6–40.5) with gemfibrozil (P < 0001, both medications compared with fish oil). CONCLUSIONS Health care providers prescribe suboptimal doses of fish oil, and adherence is poor. Even at low doses (2 g/d), though, fish oil lowers TGs by 29%. PMID:26073390

  18. Evaluation of the efficacy of a nurse practitioner-led home-based congestive heart failure clinical pathway.

    PubMed

    Moore, Jo-Ann Mary

    2016-01-01

    Frequent exacerbations of symptoms and financial penalties for 30-day hospital readmissions of patients with congestive heart failure (CHF) have led to new disease management approaches. A nurse practitioner (NP)-led interdisciplinary program for CHF management that included home telemonitoring and early NP assessments and interventions was piloted by a home health agency. A 4-month evaluation of the efficacy of a clinical pathway for CHF patients resulted in the enrollment of 22 CHF patients in the program. Two clients were readmitted within 30 days. The new program was effective in reducing 30-day readmission rates to 9% compared to the national average of 23%. PMID:27064361

  19. Peptide Fingerprinting of Alzheimer's Disease in Cerebrospinal Fluid: Identification and Prospective Evaluation of New Synaptic Biomarkers

    PubMed Central

    Zürbig, Petra; Raedler, Thomas J.; Arlt, Sönke; Kellmann, Markus; Mullen, William; Eichenlaub, Martin; Mischak, Harald; Wiedemann, Klaus

    2011-01-01

    Background Today, dementias are diagnosed late in the course of disease. Future treatments have to start earlier in the disease process to avoid disability requiring new diagnostic tools. The objective of this study is to develop a new method for the differential diagnosis and identification of new biomarkers of Alzheimer's disease (AD) using capillary-electrophoresis coupled to mass-spectrometry (CE-MS) and to assess the potential of early diagnosis of AD. Methods and Findings Cerebrospinal fluid (CSF) of 159 out-patients of a memory-clinic at a University Hospital suffering from neurodegenerative disorders and 17 cognitively-healthy controls was used to create differential peptide pattern for dementias and prospective blinded-comparison of sensitivity and specificity for AD diagnosis against the Criterion standard in a naturalistic prospective sample of patients. Sensitivity and specificity of the new method compared to standard diagnostic procedures and identification of new putative biomarkers for AD was the main outcome measure. CE-MS was used to reliably detect 1104 low-molecular-weight peptides in CSF. Training-sets of patients with clinically secured sporadic Alzheimer's disease, frontotemporal dementia, and cognitively healthy controls allowed establishing discriminative biomarker pattern for diagnosis of AD. This pattern was already detectable in patients with mild cognitive impairment (MCI). The AD-pattern was tested in a prospective sample of patients (n = 100) and AD was diagnosed with a sensitivity of 87% and a specificity of 83%. Using CSF measurements of beta-amyloid1-42, total-tau, and phospho181-tau, AD-diagnosis had a sensitivity of 88% and a specificity of 67% in the same sample. Sequence analysis of the discriminating biomarkers identified fragments of synaptic proteins like proSAAS, apolipoprotein J, neurosecretory protein VGF, phospholemman, and chromogranin A. Conclusions The method may allow early differential diagnosis of various

  20. Prospective phase II trial to evaluate the complications and kinetics of chimerism induction following allogeneic hematopoietic stem cell transplantation with fludarabine and busulfan.

    PubMed

    Saito, Akiko M; Kami, Masahiro; Mori, Shin-Ichiro; Kanda, Yoshinobu; Suzuki, Ritsuro; Mineishi, Shin; Takami, Akiyoshi; Taniguchi, Shuichi; Takemoto, Yoshinobu; Hara, Masamichi; Yamaguchi, Masaki; Hino, Masayuki; Yoshida, Takashi; Kim, Sung-Won; Hori, Akiko; Ohashi, Yasuo; Takaue, Yoichi

    2007-10-01

    This prospective trial assessed the safety and efficacy of allogeneic hematopoietic stem cell transplantation from a HLA-matched donor with a reduced-intensity regimen (RIST) consisting of iv fludarabine 30 mg/m(2) for 6 days and oral busulfan 4 mg/kg/day for 2 days in patients older than 50 years with hematological malignancies. Cyclosporine alone or cyclosporine with short-term methotrexate was randomized for graft-versus-host disease prophylaxis. After 30 patients had been enrolled, an interim analysis was performed, and this report focuses on a precise evaluation of the toxicity profile and chimerism kinetics. Sustained engraftment in all patients, no severe regimen-related toxicity (RRT) within 20 days, and no transplant-related mortality through Day 100 were observed. T-cell (CD3+) full-donor (over 90%) chimerism was observed in 22 of the 30 patients, while the remaining eight had mixed-donor chimerism over 77% on Day 90. Thereafter, five subsequently converted to full-donor chimerism without donor lymphocyte infusion by day 120 (n = 4) or Day 180 (n = 1). Two showed persistent mixed chimerism without relapse through Day 180. Grade III-IV acute graft-versus-host disease and extensive chronic graft-versus-host disease occurred in 10% and 73%, respectively. With a median follow-up of 1.5 years, overall survival and disease-free survival at 1 year was 83% and 62%, respectively. Seven patients hematologically relapsed overall, and five of them had myelodysplastic syndrome with poor prognostic factors. In older patients, RIST with fludarabine and busulfan was associated with acceptable toxicities and a satisfactory antileukemia effect, regardless of the early chimerism status. PMID:17570513

  1. Prospective Study Evaluating Postoperative Radiotherapy Plus 2-Year Androgen Suppression for Post-Radical Prostatectomy Patients With Pathologic T3 Disease and/or Positive Surgical Margins

    SciTech Connect

    Choo, Richard Danjoux, Cyril; Gardner, Sandra; Morton, Gerard; Szumacher, Ewa; Loblaw, D. Andrew; Cheung, Patrick; Pearse, Maria

    2009-10-01

    Purpose: To determine the efficacy of a combined approach of postoperative radiotherapy (RT) plus 2-year androgen suppression (AS) for patients with pathologic T3 disease (pT3) and/or positive surgical margins (PSM) after radical prostatectomy (RP). Methods and Materials: A total of 78 patients with pT3 and/or PSM after RP were treated with RT plus 2-year AS, as per a pilot, prospective study. Androgen suppression started within 1 month after the completion of RT and consisted of nilutamide for 4 weeks and buserelin acetate depot subcutaneously every 2 months for 2 years. Relapse-free rate, including freedom from prostate-specific antigen (PSA) relapse, was estimated using the Kaplan-Meier method. A Cox regression analysis was performed to evaluate prognostic factors for relapse. Prostate-specific antigen relapse was defined as a PSA rise above 0.2 ng/mL, with two consecutive increases over a minimum of 3 months. Results: The median age was 61 years at the time of RP. The median interval between RP and postoperative RT was 4.2 months. Forty-nine patients had undetectable PSA (<0.2 ng/mL), and 29 had persistently detectable postoperative PSA at the time of the protocol treatment. Median follow-up from RT was 6.4 years. Relapse-free rates at 5 and 7 years were 94.4% and 86.3%, respectively. Survival rates were 96% at 5 years and 93.1% at 7 years. On Cox regression analysis, persistently detectable postoperative PSA and pT3b-T4 were significant predictors for relapse. Conclusion: The combined treatment of postoperative RT plus 2-year AS yielded encouraging results for patients with pT3 and/or PSM and warrants a confirmatory study.

  2. 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

  3. 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.

  4. Prospective Evaluation of Ultrasound Accuracy in the Detection of Pelvic Carcinomatosis in Patients with Ovarian Cancer.

    PubMed

    Weinberger, Vit; Fischerova, Daniela; Semeradova, Ivana; Slama, Jiri; Dundr, Pavel; Dusek, Ladislav; Cibula, David; Zikan, Michal

    2016-09-01

    We analyzed the accuracy of transvaginal sonography in detection of pelvic carcinomatosis in ovarian cancer patients and factors (age, body mass index, performance status, ascites, stage, histotype, tumor grade) influencing the performance of ultrasound. In this prospective study, all 191 consecutively included patients underwent a pre-operative ultrasound staging examination according to institutional protocol. Peritoneal spread was assessed on the basis of peri-operative findings or histology. The area under the receiver operating characteristic curve for the detection of carcinomatosis was 0.90 (0.84-0.93); the sensitivity was 84% (95% confidence interval [CI]: 75%-%90), specificity 96% (95% CI: 89%-99%), positive predictive value 96% (95% CI: 89%-99%), negative predictive value 83% (95% CI: 74%-90%) and overall accuracy 89% (95% CI: 84%-93%). We report that transvaginal sonography is clinically useful in the detection of pelvic carcinomatosis. PMID:27365257

  5. Complications of continuous renal replacement therapy in critically ill children: a prospective observational evaluation study

    PubMed Central

    2009-01-01

    Introduction Continuous renal replacement therapy (CRRT) frequently gives rise to complications in critically ill children. However, no studies have analyzed these complications prospectively. The purpose of this study was to analyze the complications of CRRT in children and to study the associated risk factors. Methods A prospective, single-centre, observational study was performed in all critically ill children treated using CRRT in order to determine the incidence of complications related to the technique (problems of catheterization, hypotension at the time of connection to the CRRT, hemorrhage, electrolyte disturbances) and their relationship with patient characteristics, clinical severity, need for vasoactive drugs and mechanical ventilation, and the characteristics of the filtration techniques. Results Of 174 children treated with CRRT, 13 (7.4%) presented problems of venous catheterization; this complication was significantly more common in children under 12 months of age and in those weighing less than 10 kg. Hypotension on connection to CRRT was detected in 53 patients (30.4%). Hypotension was not associated with any patient or CRRT characteristics. Clinically significant hemorrhage occurred in 18 patients (10.3%); this complication was not related to any of the variables studied. The sodium, chloride, and phosphate levels fell during the first 72 hours of CRRT; the changes in electrolyte levels during the course of treatment were not found to be related to any of the variables analyzed, nor were they associated with mortality. Conclusions CRRT-related complications are common in children and some are potentially serious. The most common are hypotension at the time of connection and electrolyte disturbances. Strict control and continuous monitoring of the technique are therefore necessary in children on CRRT. PMID:19925648

  6. 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.

  7. 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

  8. China Patient-centered Evaluative Assessment of Cardiac Events Prospective Study of Acute Myocardial Infarction: Study Design

    PubMed Central

    Li, Jing; Dreyer, Rachel P; Li, Xi; Du, Xue; Downing, Nicholas S; Li, Li; Zhang, Hai-Bo; Feng, Fang; Guan, Wen-Chi; Xu, Xiao; Li, Shu-Xia; Lin, Zhen-Qiu; Masoudi, Frederick A; Spertus, John A; Krumholz, Harlan M; Jiang, Li-Xin

    2016-01-01

    Background: Despite the rapid growth in the incidence of acute myocardial infarction (AMI) in China, there is limited information about patients’ experiences after AMI hospitalization, especially on long-term adverse events and patient-reported outcomes (PROs). Methods: The China Patient-centered Evaluative Assessment of Cardiac Events (PEACE)-Prospective AMI Study will enroll 4000 consecutive AMI patients from 53 diverse hospitals across China and follow them longitudinally for 12 months to document their treatment, recovery, and outcomes. Details of patients’ medical history, treatment, and in-hospital outcomes are abstracted from medical charts. Comprehensive baseline interviews are being conducted to characterize patient demographics, risk factors, presentation, and healthcare utilization. As part of these interviews, validated instruments are administered to measure PROs, including quality of life, symptoms, mood, cognition, and sexual activity. Follow-up interviews, measuring PROs, medication adherence, risk factor control, and collecting hospitalization events are conducted at 1, 6, and 12 months after discharge. Supporting documents for potential outcomes are collected for adjudication by clinicians at the National Coordinating Center. Blood and urine samples are also obtained at baseline, 1- and 12-month follow-up. In addition, we are conducting a survey of participating hospitals to characterize their organizational characteristics. Conclusion: The China PEACE-Prospective AMI study will be uniquely positioned to generate new information regarding patient's experiences and outcomes after AMI in China and serve as a foundation for quality improvement activities. PMID:26712436

  9. A prospective evaluation of short-term health-related quality of life in patients undergoing anterior skull base surgery.

    PubMed

    Abergel, Abraham; Fliss, Dan M; Margalit, Nevo; Gil, Ziv

    2010-01-01

    We evaluated the health-related quality of life (QOL) of patients undergoing anterior skull base tumor resection. The Anterior Skull Base Surgery QOL questionnaire, a disease-specific multidimensional instrument dedicated to this population, was used to collect and prospectively analyze demographic, medical, and QOL data on 48 patients. Thirty-nine patients completed the questionnaire preoperatively and at 6 and 12 months postoperatively. Seventeen patients (44%) had malignant histology and 22 (56%) had benign tumors. The overall QOL score decreased significantly at 6 months postoperatively (p < 0.05) and improved significantly at 12 months postoperatively (p < 0.04). The emotional domain improved significantly at 12 months postoperatively compared with the preoperative scores (p < 0.03). Patients with malignant tumors had lower scores at 6 months postoperatively compared with patients with benign lesions (p < 0.002), although the scores for both groups at 12 months postoperatively were similar. Adjuvant radiation therapy was associated with a poor QOL (p < 0.005). The results of this prospective study show that the overall deteriorated QOL of patients after anterior skull base tumor resection returns to baseline by 1 year after surgery. Histology and radiotherapy are significant predictors of health-related QOL in this population. PMID:20592855

  10. The Efficacy and Safety of Icotinib in Patients with Advanced Non-Small Cell Lung Cancer Previously Treated with Chemotherapy: A Single-Arm, Multi-Center, Prospective Study

    PubMed Central

    Shi, Yuankai; Zhou, Caicun; Liu, Xiaoqing; Wang, Dong; Song, Yong; Li, Qiang; Feng, Jifeng; Qin, Shukui; Xv, Nong; Zhou, Jianying; Zhang, Li; Hu, Chunhong; Zhang, Shucai; Luo, Rongcheng; Wang, Jie; Tan, Fenlai; Wang, Yinxiang; Ding, Lieming; Sun, Yan

    2015-01-01

    Background Icotinib is a small molecule targeting epidermal growth factor receptor tyrosine kinase, which shows non-inferior efficacy and better safety comparing to gefitinib in previous phase III trial. The present study was designed to further evaluate the efficacy and safety of icotinib in patients with advanced non-small-cell lung cancer (NSCLC) previously treated with platinum-based chemotherapy. Methods Patients with NSCLC progressing after one or two lines of chemotherapy were enrolled to receive oral icotinib (125mg tablet, three times per day). The primary endpoint was progression-free survival. The secondary endpoints included overall survival, objective response rate, time to progression, quality of life and safety. Results From March 16, 2010 to October 9, 2011, 128 patients from 15 centers nationwide were enrolled, in which 124 patients were available for efficacy evaluation and 127 patients were evaluable for safety. The median progression-free survival and time to progression were 5.0 months (95%CI 2.9–6.6 m) and 5.4 months (95%CI 3.1–7.9 m), respectively. The objective response rate and disease control rate were 25.8% and 67.7% respectively. Median overall survival exceeded 17.6 months (95%CI 14.2 m-NA) according to censored data. Further follow-up of overall survival is ongoing. The most frequent treatment-related adverse events were rash (26%, 33/127), diarrhea (12.6%, 16/127) and elevation of transaminase (15.7%, 20/127). Conclusions In general, this study showed similar efficacy and numerically better safety when compared with that in ICOGEN trial, further confirming the efficacy and safety of icotinib in treating patients with advanced NSCLC previously treated with chemotherapy. Trial Registration ClinicalTrials.gov NCT02486354 PMID:26599904

  11. Evaluation of a Cognitive Rehabilitation Protocol in HIV Patients with Associated Neurocognitive Disorders: Efficacy and Stability Over Time

    PubMed Central

    Livelli, Alessandro; Orofino, Gian Carlo; Calcagno, Andrea; Farenga, Mariana; Penoncelli, Donatella; Guastavigna, Marta; Carosella, Sinibaldo; Caramello, Pietro; Pia, Lorenzo

    2015-01-01

    The primary aim of the present study was to evaluate the efficacy and stability over time of a cognitive rehabilitation protocol (restorative and compensatory approach) in HIV/AIDS patients with HIV-associated Neurocognitive Disorder (HAND). At baseline, 32 HIV/AIDS patients (16 with and 16 without HAND) were assessed with a neuropsychological battery (i.e., pre-assessment) consisting of 22 tests covering eight cognitive domains. Then, the experimental group was administered over 4 months a cognitive rehabilitation protocol aimed at improving four cognitive domains by means of eight paper and pencil/computer-based exercises. The control group received guideline-adherent clinical care (i.e., standard of care). At the end of the cognitive treatment, both groups were re-administered the neuropsychological battery (i.e., post-assessment). Additionally, 6 months after post-assessment, the experimental group was given the same neuropsychological battery (i.e., follow up-assessment). In order to test the efficacy of the cognitive rehabilitation protocol, we compared between groups the results of the neuropsychological battery at the pre- and post-assessments. In order to evaluate the stability over time, the effects of the cognitive rehabilitation protocol was examined comparing within the experimental group the results of the neuropsychological battery at post- and follow up-assessments. Our results show that the two groups did not differ at the pre-assessment, but differed at post-assessment. Specifically, the experimental group showed a significant improvement in five domains (Learning and memory, Abstraction/executive functioning, Verbal fluency, Attention/working memory, and Functional), whereas the control group significantly worsened in the same domains. The improvement of the experimental group did not change in the follow up-assessment in two domains (Abstraction/executive functioning, Attention/working memory, and Functional). Overall, these findings support the

  12. Development and preliminary validation of an integrated efficacy-tolerability composite measure for the evaluation of analgesics.

    PubMed

    Katz, Nathaniel P; Mou, Joy; Trudeau, Jeremiah; Xiang, Jim; Vorsanger, Gary; Orman, Camille; Kim, Myoung

    2015-07-01

    The goal of this analysis was to develop and evaluate integrated measures of benefit and tolerability of analgesic drugs in clinical trials. We evaluated an efficacy-tolerability composite (ETC) measure combining different cutoff values for daily pain reduction (≥20%, ≥30%, or ≥50% pain reduction) and adverse events (AEs) (no AE, no or mild AEs, no or mild drug-related AEs). Nine ETC cutoff values (3 × 3) were tested using data from a randomized double-blind trial comparing tapentadol extended release (ER) (n = 310), oxycodone controlled release (CR) (n = 322), and placebo (n = 314) in subjects with chronic low back pain. Efficacy-tolerability composite scores were calculated as the mean number of days a subject met the ETC criterion divided by the number of days the subject was expected to be in study; ETC scores were then averaged in each treatment group. For all 9 ETC measures, validity was demonstrated by significant correlation of ETC scores with patients' Global Impression of change and with change from baseline in pain scores. Tapentadol ER ETC scores were statistically significantly higher than oxycodone CR ETC scores for 4 of the ETC measures. "No/mild drug-related AE and ≥20% pain reduction" demonstrated the best overall validity (correlation with patients' global impression of change) and responsiveness (discrimination between treatment groups), yielding a higher standardized effect size for tapentadol ER compared with placebo (0.19 [95% confidence interval: 0.031-0.346]) and with oxycodone CR (0.23 [95% confidence interval: 0.070-0.383]) than other cutoff values. Thus, we have identified herein a composite measure that seems to be a valid and responsive measure of the overall efficacy and tolerability of analgesics in clinical trials. PMID:25867124

  13. Efficacy of a smoking cessation program in a population of adolescent smokers in vocational schools: a public health evaluative controlled study

    PubMed Central

    2013-01-01

    Background To evaluate the public health efficacy of a community-based smoking cessation program (TABADO) among vocational school trainees (15 to 20 years old). Methods This prospective, controlled, quasi-experimental study was conducted in eight vocational training centres (VTC) in France. The intervention group underwent the TABADO program, which included a general information session for all students and small-group sessions plus individual counselling and nicotine therapy, if needed, for volunteers in an enhanced program. The control group received no specific intervention other than the educational services usually available. The primary outcome was 30-day point prevalence abstinence at 12 months. Results The mean age of the 1,814 students included was 16.9 years (SD = 1.0); 84.7% were males. At baseline, 52% were smokers and 5.7% ex-smokers. In the intervention group, 24.6% of smokers volunteered for the enhanced program and 18.1% could be included. By 12-month follow-up, with participants lost to follow-up considered non-abstinent, 10.6% of smokers in the intervention group had become abstinent versus 7.4% in the control group (adjusted p = 0.03; odds ratio [OR] = 1.8; 95% confidence interval [CI] = 1.05–3.0); considering lost to follow-up as missing data, 17% of intervention group participants were abstinent versus 11.9% in the control group (univariate p = 0.08; adjusted p = 0.008; OR = 2.1; 95% CI = 1.2–3.6). Conclusion The TABADO program, targeting teenagers in vocational schools, was effective in producing a higher 12-month abstinence rate among all smokers in the intervention group. Trial registration Clinical trial identification number is NTC00973570. PMID:23418994

  14. A Comparative Study to Evaluate the Efficacy of Vaginal vs Oral Prostaglandin E1 Analogue (Misoprostol) in Management of First Trimester Missed Abortion

    PubMed Central

    Gupta, Supriya; Batra, Neera Parothi; Bhasin, Vidhu; Sarna, Veena; Kaur, Nirlep

    2016-01-01

    Introduction Missed miscarriages, occurring in upto 15% of all clinically recognized pregnancies are a cause of concern for the patients. Though many researchers in the past have compared the surgical and medical approaches in management of such patients, only a few have executed an appraisal of two routes of misoprostol at equal dosages in treatment of first trimester missed miscarriages. Aim To compare the efficacy of misoprostol by vaginal and oral route, for the management of first trimester missed abortion; and to recognize the utility of misoprostol for cervical dilation prior to any surgical termination of pregnancy. Materials and Methods A randomized prospective trial, comparing the efficacy of misoprostol, by vaginal and oral routes, for termination of first trimester missed abortion was conducted in the Department of Obstetrics and Gynecology, Government Multi-Specialty Hospital, Chandigarh over one year. Hundred subjects satisfying the inclusion criteria from 213 consecutive women presenting to the institute with first trimester missed abortion were hospitalized. The study participants were randomly assigned to one of the two treatment groups, using sequentially numbered envelopes, to receive 400mcg misoprostol vaginally or orally to a maximum of three doses six hours apart, and outcome documented. Patients were followed up on Day 14 and 6 weeks after discharge. Primary outcome evaluated was drug-induced complete expulsion of Products of Conception (POCs). Secondary outcomes measured were induction expulsion interval, number of doses required, classification of failures, cervical canal permeability in women requiring surgical evacuation, side effects, hemoglobin drop, duration and amount of post-abortal bleeding, time of resumption of menses, experience with side effects, patient satisfaction and acceptability to treatment. Results Both routes were highly effective (vaginal=92%, oral= 74%, p=0.032), safe and acceptable with tolerable side effects. The

  15. Differentiated Evaluation of Extract-Specific Evidence on Cimicifuga racemosa's Efficacy and Safety for Climacteric Complaints.

    PubMed

    Beer, A-M; Neff, A

    2013-01-01

    Past reviews on Cimicifuga racemosa (CR) without differentiation between extracts, quality, and indication altogether led to inconsistent data. Therefore, for the first time, we meet the requirements of the system's logic of evidence-based phytotherapy by taking into consideration extracts, pharmaceutical quality (reflected in a regulatory status as medicinal product), and indication. A literature search for clinical studies examining CR's efficacy and safety for menopausal complaints was conducted. The results were sorted by type of extract, regulatory status, and indication. Accordingly, Oxford Levels of Evidence (LOE) and Grades of Recommendation (GR) were determined. CR extracts demonstrated a good to very good safety in general, on estrogen-sensitive organs and the liver. However, only registered CR medicinal products were able to prove their efficacy. Best evidence was provided by the isopropanolic CR extract (iCR): the multitude of studies including more than 11,000 patients demonstrated consistent confirmatory evidence of LOE 1b (LOE 1a for safety) leading to GR A. The studies on the ethanolic extract BNO 1055 including more than 500 patients showed exploratory evidence of LOE 2b resulting in GR B. A positive benefit-risk profile is stated and limited to Cimicifuga racemosa products holding a marketing authorisation for treating climacteric complaints. PMID:24062793

  16. Evaluation of Nitazoxanide and Oxfendazole Efficacy against Cystic Echinococcosis in Naturally Infected Sheep

    PubMed Central

    Gavidia, Cesar M.; Gonzalez, Armando E.; Lopera, Luis; Jayashi, Cesar; Angelats, Roxana; Barron, Eduardo A.; Ninaquispe, Berenice; Villarreal, Lucia; Garcia, Hector H.; Verastegui, Manuela R.; Gilman, Robert H.

    2009-01-01

    Cystic echinococosis (CE) is a public health problem caused by Echinococcus granulosus. We aimed to determine the efficacy of nitazoxanide (NTZ) and oxfendazole (OXF) against CE in naturally infected sheep. A total of 151 ewes were assigned to the following groups: 15 mg/kg of NTZ weekly for five weeks (NTZ5); two rounds of 15 mg/kg of NTZ a day for five days (NTZ5×2) two weeks apart; 30 mg/kg of OXF a week for 11 weeks (OXF11); 30 mg/kg of OXF plus 15 mg/kg of NTZ a week for 11 weeks (OXF/NTZ); and the control group. OXF11 and OXF/NTZ decreased the number of fertile cysts, increased the number of degenerated cysts, and were more efficacious (49.6–61.2%) against lung cysts and liver cysts (91.8–100%) than any other treatment group. OXF might be an additional strategy for control programs and an optional treatment of human CE after it is licensed. PMID:19270283

  17. Evaluation of the efficacy of tulathromycin as a metaphylactic antimicrobial in feedlot calves.

    PubMed

    Booker, Calvin W; Abutarbush, Sameeh M; Schunicht, Oliver C; Jim, G Kee; Perrett, Tye; Wildman, Brian K; Guichon, P Timothy; Pittman, Tom J; Jones, Corey; Pollock, Colleen M

    2007-01-01

    The purpose of this study was to determine the efficacy and cost-effectiveness of tulathromycin (DRAX) versus tilmicosin (MIC) or oxytetracycline (TET) as a metaphylactic antimicrobial in feedlot calves. Calves that received DRAX had significantly (P<.05) lower initial undifferentiated fever (UF) treatment and relapse rates; lower overall chronicity, overall mortality, and cause-specific mortality rates; higher average daily gains; and improved quality grades. However, calves that received DRAX also had poorer (P<.05) yield grades compared with calves that received MIC or TET and worse feed conversion compared with calves that received MIC. Net advantages in the DRAX group were 3.79CanDollars/animal and 16.96CanDollars/animal compared with the MIC and TET groups, respectively. Based on these results, DRAX is a more efficacious and cost-effective metaphylactic antimicrobial than MIC or TET in feedlot calves at ultra-high risk of developing UF. In addition, this study presents a comparison between two methods ("deads out" and "deads in") of calculating feedlot performance variables. PMID:17926304

  18. Comparative evaluation of the aphrodisiac efficacy of sildenafil and Carpolobia lutea root extract in male rabbits

    PubMed Central

    Dare, Ayobami; Salami, Shakiru Ademola; Kunle-Alabi, Olufadekemi Tolulope; Akindele, Opeyemi Oreofe; Raji, Yinusa

    2015-01-01

    Aims: In spite of the folkloric use of the root of Carpolobia lutea as a sexual stimulant in man, there has been limited scientific proof of its efficacy. This study compares the efficacy of methanol extract of C. lutea root (MECLR) and sildenafil on the sexual activity of male rabbits. Methods: 20 adult male rabbits were grouped into four of five rabbits each. Groups 1-4 were treated orally for 28 days with 2 ml/kg 1% Tween-20 (vehicle), 40 mg/kg MECLR, 80 mg/kg MECLR, and 0.5 mg/kg sildenafil citrate (SC), respectively. Sexual activities of males from each group were assessed by cohabiting them with sexually receptive female at estrus on days 0, 1, 3, and 5 using digital camera mounted on mating arena. Serum testosterone and nitric oxide concentration of the corpora cavernosa homogenates were also determined. Results: MECLR caused a dose-dependent significant increase in mount frequency, intromission frequency and ejaculatory latency (EL) while it reduced mount latency, intromission latency and post EL (similar to SC) when compared with the control. MECLR also caused significant increase in nitric oxide concentration in corpora cavernosa but no change in serum testosterone concentration. Conclusions: Results suggest that MECLR enhances male sexual activity possibly by augmenting nitric oxide concentration. This study thus provides a novel scientific rationale for the use of C. lutea in the management of penile erectile dysfunction and impaired libido. PMID:26649235

  19. Differentiated Evaluation of Extract-Specific Evidence on Cimicifuga racemosa's Efficacy and Safety for Climacteric Complaints

    PubMed Central

    Beer, A.-M.; Neff, A.

    2013-01-01

    Past reviews on Cimicifuga racemosa (CR) without differentiation between extracts, quality, and indication altogether led to inconsistent data. Therefore, for the first time, we meet the requirements of the system's logic of evidence-based phytotherapy by taking into consideration extracts, pharmaceutical quality (reflected in a regulatory status as medicinal product), and indication. A literature search for clinical studies examining CR's efficacy and safety for menopausal complaints was conducted. The results were sorted by type of extract, regulatory status, and indication. Accordingly, Oxford Levels of Evidence (LOE) and Grades of Recommendation (GR) were determined. CR extracts demonstrated a good to very good safety in general, on estrogen-sensitive organs and the liver. However, only registered CR medicinal products were able to prove their efficacy. Best evidence was provided by the isopropanolic CR extract (iCR): the multitude of studies including more than 11,000 patients demonstrated consistent confirmatory evidence of LOE 1b (LOE 1a for safety) leading to GR A. The studies on the ethanolic extract BNO 1055 including more than 500 patients showed exploratory evidence of LOE 2b resulting in GR B. A positive benefit-risk profile is stated and limited to Cimicifuga racemosa products holding a marketing authorisation for treating climacteric complaints. PMID:24062793

  20. Evaluation of disinfection efficacy and chemical formation using MPUV ballast water treatment system (GloEn-Patrol).

    PubMed

    Jung, Yeon Jung; Yoon, Yeojoon; Pyo, Tae Sung; Lee, Soo-Tae; Shin, Kyoungsoon; Kang, Joon-Wun

    2012-09-01

    This study was undertaken to evaluate the efficacy of inactivation of several indigenous marine species and the formation of oxidants and other by-products using medium-pressure ultraviolet (MPUV) ballast water treatment. The ballast water treatment system (BWTS) used in this study was composed of filtration modules as a pretreatment process, followed by a UV irradiation process equipped with a polychromatic MPUV lamp. The experiments were performed on seawater (Busan, >32 PSU) and brackish water (Nakdong River, 20-22 PSU) with flow rates of 50 and 250 m(3)/h. The disinfection efficacy of the system was evaluated using indigenous species (>50 microm and 10-50 microm) and surrogate microorganisms (E. coli and Enterococci group). The test results successfully met the D-2 regulation of the IMO (International Marine Organization). In addition, oxidants, such as H202, total residual oxidants (TRO) and OH radicals, and potential halogenated by-products, such as haloacetic acids, trihalomethanes and total organic halides, that had potentially formed after MPUV treatment, were measured. In conclusion, the ballast water treatment system employing the MPUV physical process not only effectively eliminated indigenous species in ballast water but also generated no harmful by-products. PMID:23240188

  1. Utility of Greater Wax Moth Larva (Galleria mellonella) for Evaluating the Toxicity and Efficacy of New Antimicrobial Agents.

    PubMed

    Desbois, Andrew P; Coote, Peter J

    2012-01-01

    There is an urgent need for new antimicrobial agents to combat infections caused by drug-resistant pathogens. Once a compound is shown to be effective in vitro, it is necessary to evaluate its efficacy in an animal infection model. Typically, this is achieved using a mammalian model, but such experiments are costly, time consuming, and require full ethical consideration. Hence, cheaper and ethically more acceptable invertebrate models of infection have been introduced, including the larvae of the greater wax moth Galleria mellonella. Invertebrates have an immune system that is functionally similar to the innate immune system of mammals, and often identical virulence and pathogenicity factors are used by human pathogenic microbes to infect wax moth larvae and mammals. Moreover, the virulence of many human pathogens is comparable in wax moth larvae and mammals. Using key examples from the literature, this chapter highlights the benefits of using the wax moth larva model to provide a rapid, inexpensive, and reliable evaluation of the toxicity and efficacy of new antimicrobial agents in vivo and prior to the use of more expensive mammalian models. This simple insect model can bridge the gap between in vitro studies and mammalian experimentation by screening out compounds with a low likelihood of success, while providing greater justification for further studies in mammalian systems. Thus, broader implementation of the wax moth larva model into anti-infective drug discovery and development programs could reduce the use of mammals during preclinical assessments and the overall cost of drug development. PMID:22305092

  2. [Susceptibility of clinically-isolated bacteria strains to respiratory quinolones and evaluation of antimicrobial agent efficacy by Monte Carlo simulation].

    PubMed

    Kosaka, Tadashi; Yamada, Yukiji; Kimura, Takeshi; Kodama, Mai; Fujitomo, Yumiko; Masaki, Nakanishi; Toshiaki, Komori; Keisuke, Shikata; Fujita, Naohisa

    2016-02-01

    Respiratory quinolones (RQs) are broad-spectrum antimicrobial agents used for the treatment of a wide variety of community-acquired and nosocomial infections. However, bacterial resistance to quinolones has been on the increase. In this study, we investigated the predicted efficacy of RQs for various strains of 9 bacterial species clinically isolated at our university hospital using the Monte Carlo simulation (MCS) method based on pharmacokinetics/pharmacodynamics modeling. In addition, the influence of the patients' renal function on the efficacy of RQs was evaluated. We surveyed antimicrobial susceptibility testing of 9 bacterial species (n = number of strains) [Streptococcus pneumoniae (n = 15), Streptococcus pyogenes (n = 14), Streptococcus agalactiae (n = 19), methicillin-susceptible Staphylococcus aureus (MSSA) (n = 24), Escherichia coli (n = 35), Haemophilus influenzae (n = 17), Klebsiella pneumoniae (n = 14), Pseudomonas aeruginosa (n = 31), and Moraxella catarrhalis (n = 11)] to 4 RQs [garenoxacin (GRNX), levofloxacin (LVFX), sitafloxacin (STFX), and moxifloxacin (MFLX)]. We found that compared with the other RQs, Gram-positive cocci was most resistant to LVFX, and that the minimum inhibitory concentration (MIC₉₀) values for S. pneumoniae, S. pyogenes, S. agalactiae, and MSSA were high (2, 16, > 16, and 8 µg/mL, respectively). In regard to Gram-negative rods, the susceptibility of E. coli to RQs was found to be decreased, with the MIC₉₀ values of GRNX, LVFX, STFX, and MFLX being > 16, 16, 1, and 16 µg/mL, respectively. MCS revealed that the target attainment rate of the area under the unbound concentration-time curve divided by the MIC₉₀ (ƒ · AUC/MIC ratio), against S. pneumoniae was 86.9-100%, but against E. coli was low (52.1-66.2%). The ƒ · AUC/MIC target attainment rate of LVFX against S. pneumoniae, S. pyogenes, and S. agalactiae tended to decrease due to increased creatinine clearance, and that of LVFX and STFX against MSSA also

  3. Development and psychometric validation of the REFlective evaLuation of psoriasis Efficacy of Treatment and Severity (REFLETS) questionnaire: a common measure of plaque-type psoriasis severity and treatment efficacy for patients and clinicians

    PubMed Central

    Gilet, H; Roborel de Climens, A; Arnould, B; Bachelez, H; Bagot, M; Beaulieu, P; Joly, P; Jullien, D; Le Maître, M; Ortonne, JP; Paul, C; Thibout, E

    2015-01-01

    Background To date, there is no global consensus on the definition of the severity of psoriasis. The REFlective evaLuation of psoriasis Efficacy of Treatment and Severity (REFLETS) questionnaire has recently been developed to provide a better understanding of plaque-type psoriasis severity and treatment efficacy from both patient and clinician perspectives. Objective This study aimed to develop and psychometrically validate the new REFLETS questionnaire to evaluate patient and clinician perceptions of plaque-type psoriasis severity and treatment efficacy. Methods Two similar versions of the REFLETS questionnaire were developed following a rigorous methodology for clinicians and patients, referring to ‘the psoriasis of your patient' or to ‘your psoriasis’, respectively. An observational, longitudinal, multicentre study was conducted in France with 34 dermatologists and 430 mild to severe plaque-type psoriasis patients to finalize the questionnaire and evaluate its psychometric properties. Results Two dimensions were defined – severity and treatment efficacy – with three subdimensions within severity (impact of psoriasis, symptoms and disease course), and two individual items on joint pain. The questionnaire was well accepted by clinicians and patients. Excellent internal consistency (Cronbach's alpha = 0.66–0.98) and test–retest reliability (intraclass correlation coefficients = 0.83–0.94) were demonstrated. REFLETS scores were moderately to highly correlated to Psoriasis Area and Severity Index (r = 0.35–0.70), Skindex-29 (r = 0.46–0.82) and DLQI scores (r = 0.36–0.82). Patients with decreased psoriasis severity and those with increased treatment efficacy, according to patient global evaluations, had lower severity and higher treatment efficacy REFLETS scores, respectively. Conclusion REFlective evaLuation of psoriasis Efficacy of Treatment and Severity is a promising tool for assessing plaque-type psoriasis severity and treatment

  4. Prospective Evaluation of Pharmacogenomics and Metabolite Measurements upon Azathioprine Therapy in Inflammatory Bowel Disease

    PubMed Central

    Fangbin, Zhang; Xiang, Gao; Liang, Ding; Hui, Liu; Xueding, Wang; Baili, Chen; Huichang, Bi; Yinglian, Xiao; Peng, Cheng; Lizi, Zhao; Yanjun, Chu; Feng, Xu; Minhu, Chen; Min, Huang; Pinjin, Hu

    2016-01-01

    Abstract Up to approximately 40% to 50% of patients discontinue thiopurine therapy during the course of inflammatory bowel disease (IBD). We investigated the role of the metabolite thiopurine in IBD treatment. This was a prospective study. IBD patients receiving azathioprine (AZA) were prospectively included. Thiopurine methyltransferase (TPMT) genotypes were examined before therapy, and thiopurine metabolite levels were examined at weeks 2, 4, 8, 12, 24, and 48. In total, 132 patients were included. The frequency of leucopenia increased at 6-thioguanine nucleotide (6-TGN) levels ≥420 pmol/8 × 108 RBC (odds ratio [OR] = 7.9; 95% confidence interval (95%CI): 3.5–18.0; P < 0.001) and increased more during the initial 12 weeks of thiopurine therapy (OR = 16.0; 95%CI: 5.7–44.9; P < 0.001). The patients with 6-TGN levels ≥420 pmol/8 × 108 RBC at weeks 4, 8, and 12 had an increased likelihood of leucopenia. Clinical response increased at 6-TGN levels ≥225 pmol/8 × 108 RBC (OR = 13.5; 95% CI: 3.7–48.9; P < 0.001) in Crohn disease (CD) patients. The CD patients with 6-TGN levels ≥225 pmol/8 × 108 RBC at weeks 8, 12, and 24 had an increased likelihood of successful clinical response. TPMT∗3C had a specificity of 100%, but a sensitivity of 8% for predicting leucopenia. A 6-TGN level between 225 and 420 pmol/8 × 108 RBC could be a therapeutic window in patients receiving AZA therapy, and it could likely predict leucopenia in the initial 12 weeks of AZA therapy and a reasonable chance of successful clinical response in CD patients. The value of TPMT genotyping before thiopurine therapy is limited in Chinese patients with IBD, considering the low sensitivity of predicting leucopenia. PMID:27082580

  5. Efficacy and safety of combined prolonged-release oxycodone and naloxone in the management of moderate/severe chronic non-malignant pain: results of a prospectively designed pooled analysis of two randomised, double-blind clinical trials

    PubMed Central

    2010-01-01

    Background Two randomised 12-week, double-blind, parallel-group, multicenter studies comparing oxycodone PR/naloxone PR and oxycodone PR alone on symptoms of opioid-induced bowel dysfunction in patients with moderate/severe non-malignant pain have been conducted. Methods These studies were prospectively designed to be pooled and the primary outcome measure of the pooled data analysis was to demonstrate non-inferiority in 12-week analgesic efficacy of oxycodone PR/naloxone PR versus oxycodone PR alone. Patients with opioid-induced constipation were switched to oxycodone PR and then randomised to fixed doses of oxycodone PR/naloxone PR (n = 292) or oxycodone PR (n = 295) for 12 weeks (20-80 mg/day). Results No statistically significant differences in analgesic efficacy were observed for the two treatments (p = 0.3197; non-inferiority p < 0.0001; 95% CI -0.07, 0.23) and there was no statistically significant difference in frequency of analgesic rescue medication use. Improvements in Bowel Function Index score were observed for oxycodone PR/naloxone PR by Week 1 and at every subsequent time point (-15.1; p < 0.0001; 95% CI -17.3, -13.0). AE incidence was similar for both groups (61.0% and 57.3% of patients with oxycodone PR/naloxone PR and oxycodone PR alone, respectively). Conclusions Results of this pooled analysis confirm that oxycodone PR/naloxone PR provides effective analgesia and suggest that oxycodone PR/naloxone PR improves bowel function without compromising analgesic efficacy. Trial registration numbers ClinicalTrials.gov identifier: NCT00412100 and NCT00412152 PMID:20920236

  6. Evaluation of Control Points in Youngstock and Adult Dairy Cow Management to Control Transmission of Mycobacterium avium subsp. paratuberculosis

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Complete a series of prospective controlled on-farm trials to critically evaluate the efficacy and cost-benefit of commonly recommended management practices for reducing the transmission of Mycobacterium avium subsp. paratuberculosis (Map) in youngstock in infected herds....

  7. Efficacy Evaluation of a New Hyaluronan Derivative HYADD® 4-G to Maintain Cartilage Integrity in a Rabbit Model of Osteoarthritis

    PubMed Central

    Schiavinato, Antonella; Ganster, Murielle Marie

    2013-01-01

    Objective: To test the efficacy of a hyaluronan derivative (HYADD®4-G) in a model of osteoarthritis (anterior cruciate ligament [ACLT]) and to compare its efficacy with the injection of growth factors. Design: In a first experimental set-up, specially selected for treatment scheme with published studies on hyaluronan or growth factor efficacy in osteoarthritis, saline, HYADD®4-G, rh-BMP-7, and the treatments of rh-BMP-7 or rh-BMP-2 with HYADD®4-G were injected after ACLT, for five times starting 3 weeks after ACLT. Euthanasia was at day 70. The knees were evaluated by gross morphological observation, x-ray, and histology (Study A). In a second experimental set-up selected to evaluate the efficacy of three viscosupplement injections, starting 4 weeks after ACTL, HYADD®4-G was compared to saline (Study B). Results: (A) X-ray analysis showed more damage in the saline group than all other treatment groups (2.67 ± 0.61 for saline, 0.83 ± 0.26 for HYADD®4-G, 1.67 ± 0.82 for HYADD®4-G with rh-BMP-2, 0.75 ± 0.76 for HYADD®4-G with rh-BMP-7, and 1.58 ± 0.49 for rh-BMP-7), P < 0.05. In the femoral condyle, the Mankin’s score for HYADD®4-G with rh-BMP-2, HYADD®4-G with rh-BMP-7, and rh-BMP7 alone was statistically lower compared to saline in the medial part; in the lateral part a significant lower value was observed in the HYADD®4-G with the rh-BMP-2 group. (B) The Kellgren and Lawrence score and Mankin’s score was lower in the HYADD®4-G group than in the saline group (P < 0.002 and P = 0.0031). Conclusions: These two studies suggest that HYADD®4-G delayed the cartilage degeneration and that the association of HYADD®4-G with growth factors is synergistic. PMID:23550192

  8. Developing Efficacy in School Leaders

    ERIC Educational Resources Information Center

    Abusham, Jaymi

    2010-01-01

    Many new school leaders will be needed in the coming years, and the demands placed upon them are increasingly complex. Research has shown that leaders need a strong sense of self-efficacy in order to succeed. This study examined the relationship between the leadership readiness beliefs of prospective school leaders and the efficacy-building…

  9. 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.

  10. Prospective Evaluation of the Effect of an Anxiety Sensitivity Intervention on Suicidality among Smokers

    PubMed Central

    Capron, Daniel W.; Norr, Aaron M.; Zvolensky, Michael J.; Schmidt, Norman B.

    2013-01-01

    Recent empirical work has revealed a significant relationship between anxiety sensitivity (AS), particularly the AS cognitive concerns subfactor, and suicidality among cigarette smokers. The current study prospectively tested whether an intervention targeting AS (i.e. an AS augmented smoking cessation program) would predict lower suicidality in a population known to be at increased risk for death by suicide (i.e. cigarette smokers). Participants (N = 169) were randomly assigned to a standard cognitive-behavioral smoking intervention or a cognitive-behavioral smoking intervention with an AS reduction component. Findings indicate the participants who received the AS augmented intervention had lower suicidality compared to those in the standard intervention, even accounting for baseline suicidality, substance use disorder diagnosis, current depression, current anxiety and current smoking status. As the first examination of the effect of an AS reduction program on suicidality, this study provides initial support for the hypothesis that reducing AS may lead to lower suicidality. Future work should include testing an AS intervention in a sample with elevated suicidality, as well as specifically targeting AS cognitive concerns, which has a stronger and more consistent relationship with suicidality than global AS. PMID:23767786

  11. Prospective multi-arm evaluation of surgical treatments for vocal fold scar and pathologic sulcus vocalis

    PubMed Central

    Welham, Nathan V.; Choi, Seong Hee; Dailey, Seth H.; Ford, Charles N.; Jiang, Jack J.; Bless, Diane M.

    2011-01-01

    Objectives/Hypothesis The purpose of this study was to compare the clinical effectiveness of type I thyroplasty, injection laryngoplasty and graft implantation for the treatment of vocal fold scar and pathologic sulcus vocalis. Study Design Prospective, multi-arm, quasi-experimental research design. Methods Twenty-eight patients with newly diagnosed vocal fold scar and/or pathologic sulcus vocalis were assigned to one of three treatment modalities: Type I thyroplasty (n = 9), injection laryngoplasty (n = 9) and graft implantation (n = 10). Psychosocial, auditory-perceptual, acoustic, aerodynamic and videostroboscopic data were collected pre-treatment and at 1, 6, 12 and 18 months post-treatment. Results Type I thyroplasty and graft implantation both resulted in reduced voice handicap with no concomitant improvement in auditory-perceptual, acoustic, aerodynamic or vocal fold physiologic performance. Injection laryngoplasty resulted in no improvement on any vocal function index. Patients who underwent graft implantation exhibited the slowest improvement trajectory across the 18 month follow-up period. Conclusions A persistent challenge in this area is that no single treatment modality is successful for the majority of patients, and there is no evidence-based decision algorithm for matching a given treatment to a given patient. Progress therefore requires the identification and categorization of predictive clinical features that can drive evidence-based treatment assignment. PMID:21557241

  12. 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. PMID:26545818

  13. A prospective study evaluating utility of Mannheim peritonitis index in predicting prognosis of perforation peritonitis

    PubMed Central

    Sharma, Rajesh; Ranjan, Vikrant; Jain, Suraj; Joshi, Tulika; Tyagi, Anurag; Chaphekar, Rohan

    2015-01-01

    Aims: We aimed to validate Mannheim peritonitis index (MPI) for prediction of outcome in patients with perforation peritonitis. Materials and Methods: A prospective study involving 100 subjects operated for perforation peritonitis over the period of 2 years was designed. Postevaluation of predesigned performa, MPI score was calculated and analyzed for each patient with death being the main outcome measure. The MPI scores were divided into three categories; scores <15 (category 1), 16-25 (category 2), and >25 (category 3). Results: Our study consisted of 82 males and 18 females (male:female ratio 4.56:1), with the mean patients age of 37.96 ± 17.49 years. 47, 26, and 27 cases belonged to MPI score categories 1, 2, and 3, respectively. The most common origin of sepsis was ileal with small intestine dominating the source of perforation. When the individual parameters of MPI score were assessed against the mortality only, age >50 years (P = 0.015), organ failure (P = 0.0001), noncolonic origin of sepsis (P = 0.002), and generalized peritonitis (P = 0.0001) significantly associated with mortality. The sensitivity of MPI was 92% with a specificity of 78% in receiver operating characteristic curves. Conclusion: MPI is an effective tool for prediction of mortality in cases of perforation peritonitis. PMID:26604619

  14. Prospective evaluation of the effect of an anxiety sensitivity intervention on suicidality among smokers.

    PubMed

    Capron, Daniel W; Norr, Aaron M; Zvolensky, Michael J; Schmidt, Norman B

    2014-01-01

    Recent empirical work has revealed a significant relationship between anxiety sensitivity (AS), particularly the AS cognitive concerns subfactor, and suicidality among cigarette smokers. The current study prospectively tested whether an intervention targeting AS (i.e. an AS-augmented smoking cessation program) would predict lower suicidality in a population known to be at increased risk for death by suicide (i.e. cigarette smokers). Participants (N = 169) were randomly assigned to a standard cognitive behavioral smoking intervention or a cognitive behavioral smoking intervention with an AS reduction component. Findings indicate that the participants who received the AS-augmented intervention had lower suicidality compared to those in the standard intervention, even accounting for baseline suicidality, substance use disorder diagnosis, current depression, current anxiety, and current smoking status. As the first examination of the effect of an AS reduction program on suicidality, this study provides initial support for the hypothesis that reducing AS may lead to lower suicidality. Future work should include testing an AS intervention in a sample with elevated suicidality, as well as specifically targeting AS cognitive concerns, which has a stronger and more consistent relationship with suicidality than global AS. PMID:23767786

  15. Prospective evaluation of small bowel preparation with bisacodyl and sodium phosphate for capsule endoscopy

    PubMed Central

    Franke, Andreas; Hummel, Frank; Knebel, Phillip; Antoni, Christoph; Böcker, Ulrich; Singer, Manfred V; Löhr, Matthias

    2008-01-01

    AIM: To determine the effect of Prepacol®, a combination of sodium phosphate and bisacodyl, on transit and quality of capsule endoscopy (CE). METHODS: Fivety two consecutive patients were included in this prospective study. CE was performed following a 12 h fasting period. Twenty six patients were randomized for additional preparation with Prepacol®. The quality of CE was assessed separately for the proximal and the distal small bowel by 3 experienced endoscopists on the basis of a graduation which was initially developed with 20 previous CE. RESULTS: Preparation with Prepacol® accelerated small bowel transit time (262 ± 55 min vs 287 ± 97 min), but had no effect on the quality of CE. Visibility was significantly reduced in the distal compared to the proximal small bowel. CONCLUSION: The significantly reduced visibility of CE in the distal small bowel allocates the need for a good preparation. Since Prepacol® has no beneficial effect on CE the modality of preparation and the ideal time of application remains unclear. Further standardized examinations are necessary to identify sufficient preparation procedures and to determine the impact of the volume of the preparation solution. PMID:18395907

  16. A Prospective, Neurophysiologic Comparative Study to Assess the Efficacy and Duration of Effect of IncobotulinumtoxinA and AbobotulinumtoxinA in the Treatment of Crow's Feet.

    PubMed

    Saybel, Anastasia; Artemenko, Ada; Nikitin, Sergei; Kurenkov, Alexei

    2015-11-01

    This randomized, rater-blind, split-face study compared the safety and efficacy of incobotulinumtoxinA and abobotulinumtoxinA for the treatment of crow's feet. Nine units of incobotulinumtoxinA were administered to the lateral periorbital region of one side of the face and 27 units of abobotulinumtoxinA to the other in healthy subjects (aged 35-55 years) with moderate-to-severe crow's feet at rest (2-3 points on the 5-point Merz Aesthetics Scale [MAS]). Investigators assessed efficacy using the MAS, while subjects assessed using a 9-point global assessment scale. Secondary objectives included electromyography to assess muscle activity before injection and at 2 weeks, 4 months, and 6 months afterwards. Twenty women were enrolled and 18 completed the study. At rest and maximum smile, at each time point, the mean wrinkle scores were significantly lower (P ≤ 0.05) than baseline for both treatments. No differences were noted between treatments. Responder (≥ 1-point improvement from baseline) rates for both products were 100% and 83% at 2 weeks and 4 months post-treatment, respectively. At 6 months post-treatment, responder rates were 67% and 61% for incobotulinumtoxinA and abobotulinumtoxinA, respectively. For both, the maximum changes in electromyography parameters were observed 2 weeks post-treatment. A response was maintained for 6 months (P ≤ 0.05 vs baseline). Both treatments were well tolerated; only mild adverse events were reported. In conclusion, for treatment of crow's feet, incobotulinumtoxinA and abobotulinumtoxinA (1:3 dose) demonstrated comparable efficacy in terms of magnitude and longevity of effect. Both products demonstrated a high responder rate, with the response being maintained for 6 months in the majority. PMID:26580879

  17. Evaluating the efficacy of remediation for struggling readers in high school.

    PubMed

    Lovett, Maureen W; Lacerenza, Léa; De Palma, Maria; Frijters, Jan C

    2012-01-01

    Preliminary efficacy data are reported for a research-based reading intervention designed for struggling readers in high school. PHAST PACES teaches (a) word identification strategies, (b) knowledge of text structures, and (c) reading comprehension strategies. In a quasi-experimental design, 268 intervention and 83 waiting list control students meeting criteria for reading disability were assessed before and after their semester. After 60 to 70 hours of PHAST PACES instruction, struggling readers demonstrated significant gains on standardized tests of word attack, word reading, and passage comprehension and on experimental measures of letter-sound knowledge and multisyllabic word identification relative to control students. An average effect size of .68 was revealed across these outcome measures. One year follow-up data on 197 PHAST PACES students revealed an average trend to decelerated growth after the intervention, except for passage comprehension outcomes that demonstrated continued growth over follow-up. PMID:22183192

  18. Biomaterial constructs for delivery of multiple therapeutic genes: a spatiotemporal evaluation of efficacy using molecular beacons.

    PubMed

    Alexander, Jennifer C; Browne, Shane; Pandit, Abhay; Rochev, Yury

    2013-01-01

    Gene therapy is emerging as a potential therapeutic approach for cardiovascular pathogenesis. An appropriate therapy may require multiple genes to enhance therapeutic outcome by modulating inflammatory response and angiogenesis in a controlled and time-dependent manner. Thus, the aim of this research was to assess the spatiotemporal efficacy of a dual-gene therapy model based on 3D collagen scaffolds loaded with the therapeutic genes interleukin 10 (IL-10), a potent anti-inflammatory cytokine, and endothelial nitric oxide synthase (eNOS), a promoter of angiogenesis. A collagen-based scaffold loaded with plasmid IL-10 polyplexes and plasmid eNOS polyplexes encapsulated into microspheres was used to transfect HUVECs and HMSCs cells.The therapeutic efficacy of the system was monitored at 2, 7 and 14 days for eNOS and IL-10 mRNA expression using RT-PCR and live cell imaging molecular beacon technology. The dual gene releasing collagen-based scaffold provided both sustained and delayed release of functional polyplexes in vitro over a 14 day period which was corroborated with variation in expression levels seen using RT-PCR and MB imaging. Maximum fold increases in IL-10 mRNA and eNOS mRNA expression levels occurred at day 7 in HMSCs and HUVECs. However, IL-10 mRNA expression levels seemed dependent on frequency of media changes and/or ease of transfection of the cell type. It was demonstrated that molecular beacons are able to monitor changes in mRNA levels at various time points, in the presence of a 3D scaffolding gene carrier system and the results complemented those of RT-PCR. PMID:23755278

  19. Evaluation of Efficacy of Herbal Intrauterine Infusion Uterofix Liquid in Treatment of Various Reproductive Disorders in Cows: A Field Study

    PubMed Central

    Verma, Satinder; Choudhary, Adarsh; Maini, Shivi; Ravikanth, K.

    2016-01-01

    Objective: To evaluate the efficacy of herbal intrauterine infusion Uterofix liquid in the treatment of various reproductive disorders in cows. Materials and Methods: Based on symptoms of endometritis, anestrous, metritis, and repeat breeders, 28 cows were selected to study the efficacy of herbal intrauterine infusion Uterofix liquid (M/S Ayurvet Limited) in uterine infections study. Group T0 (n = 8) cows served as control group, no treatment was given to this group, Group T1 (n = 5) repeat breeder cows, Group T2 (n = 5) endometritis effected cows, Group T3 (n = 5) anoestrus cows, and Group T4 (n = 5) metritis suffered cows were treated with Uterofix liquid (25 ml as intrauterine infusion once a day for 3–5 days). Total observational period was 60 days. Number of treatments needed, nature of discharge in first posttreatment estrus (physical examination), after treatment number of animal showing heat/estrus out of total treated, and posttreatment conception rate were used as criteria to judge the success or failure of treatment. Results: Results revealed that 18 out of 20 animals (90%) showed signs of heat with clear discharge, recovered completely without causing any irritation, or severe irritation/sloughing of genital mucous membrane after Uterofix liquid treatment. Conclusion: Herbal intrauterine infusion Uterofix liquid significantly treated the uterine infections in cows. SUMMARY Uterine infection is a major problem in reproductive management. A wide variety of genital tract diseases of female domestic animals are known to produce significant losses and responsible for poor fertility. Amongst these highly prevalent are metritis and repeat breeding in high-producing dairy cows which if remains untreated are associated with low conception rate per artificial insemination (AI), extended interval to pregnancy, increased culling, and economic losses. As herbal remedy the Uterofix liquid (Ayurvet Limited, India) was highly efficacious as an intrauterine infusion

  20. In vivo biodistribution, biocompatibility, and efficacy of sorafenib-loaded lipid-based nanosuspensions evaluated experimentally in cancer

    PubMed Central

    Yang, Shaomei; Zhang, Bo; Gong, Xiaowei; Wang, Tianqi; Liu, Yongjun; Zhang, Na

    2016-01-01

    Hepatocellular carcinoma (HCC) is one of the most common malignant tumors worldwide. In this study, sorafenib-loaded lipid-based nanosuspensions (sorafenib-LNS) were first developed as an intravenous injectable formulation to increase the efficacy of sorafenib against HCC. LNS were used as nanocarriers for sorafenib owing to their desired features in increasing the solubility and dissolution velocity, improving the bioavailability of sorafenib. Sorafenib-LNS were prepared by nanoprecipitation and consisted of spherical particles with a uniform size distribution (164.5 nm, polydispersity index =0.202) and negative zeta potential (−11.0 mV). The drug loading (DL) was 10.55%±0.16%. Sorafenib-LNS showed higher in vitro cytotoxicity than sorafenib against HepG2 cells (P<0.05) and Bel-7402 cells (P<0.05). The in vivo biodistribution, biocompatibility, and antitumor efficacy of sorafenib-LNS were evaluated in H22-bearing liver cancer xenograft murine model. The results showed that sorafenib-LNS (9 mg/kg) exhibited significantly higher antitumor efficacy by reducing the tumor volume compared with the sorafenib oral group (18 mg/kg, P<0.05) and sorafenib injection group (9 mg/kg, P<0.05). Furthermore, the results of the in vivo biodistribution experiments demonstrated that sorafenib-LNS injected into H22 tumor-bearing mice exhibited increased accumulation in the tumor tissue, which was confirmed by in vivo imaging. In the current experimental conditions, sorafenib-LNS did not show significant toxicity both in vitro and in vivo. These results suggest that sorafenib-LNS are a promising nanomedicine for treating HCC. PMID:27307733

  1. Exploring of Primate Models of Tick-Borne Flaviviruses Infection for Evaluation of Vaccines and Drugs Efficacy

    PubMed Central

    Pripuzova, Natalia S.; Gmyl, Larissa V.; Romanova, Lidiya Iu.; Tereshkina, Natalia V.; Rogova, Yulia V.; Terekhina, Liubov L.; Kozlovskaya, Liubov I.; Vorovitch, Mikhail F.; Grishina, Karina G.; Timofeev, Andrey V.; Karganova, Galina G.

    2013-01-01

    Tick-borne encephalitis virus (TBEV) is one of the most prevalent and medically important tick-borne arboviruses in Eurasia. There are overlapping foci of two flaviviruses: TBEV and Omsk hemorrhagic fever virus (OHFV) in Russia. Inactivated vaccines exist only against TBE. There are no antiviral drugs for treatment of both diseases. Optimal animal models are necessary to study efficacy of novel vaccines and treatment preparations against TBE and relative flaviviruses. The models for TBE and OHF using subcutaneous inoculation were tested in Cercopithecus aethiops and Macaca fascicularis monkeys with or without prior immunization with inactivated TBE vaccine. No visible clinical signs or severe pathomorphological lesions were observed in any monkey infected with TBEV or OHFV. C. aethiops challenged with OHFV showed massive hemolytic syndrome and thrombocytopenia. Infectious virus or viral RNA was revealed in visceral organs and CNS of C. aethiops infected with both viruses; however, viremia was low. Inactivated TBE vaccines induced high antibody titers against both viruses and expressed booster after challenge. The protective efficacy against TBE was shown by the absence of virus in spleen, lymph nodes and CNS of immunized animals after challenge. Despite the absence of expressed hemolytic syndrome in immunized C. aethiops TBE vaccine did not prevent the reproduction of OHFV in CNS and visceral organs. Subcutaneous inoculation of M. fascicularis with two TBEV strains led to a febrile disease with well expressed viremia, fever, and virus reproduction in spleen, lymph nodes and CNS. The optimal terms for estimation of th