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Sample records for prospective efficacy evaluation

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

    PubMed

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

    2013-12-01

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

  2. [Application and prospect of scale measurement and appraisal in the assessment in TCM therapeutic efficacy evaluation].

    PubMed

    Liu, Feng-Bin

    2007-12-01

    The assessing contents of the health related quality of life (HRQOL) and the patient reported outcomes (PRO) are identical with the inquiry of traditional Chinese medicine (TCM), which are uniformly soft indicators which could be evaluated with the scales for instruments. The assessing method for the soft indicator in the HRQOL and PRO was gradually accepted by TCM practitioners and applied in evaluating the curative effect of TCM. The applying scale in the assessment of curative effect of TCM and the developing scale with the TCM features just started in the TCM field. There was much inadequacy in the scale study, such as no penetrating understanding of the theory and connotation of the scale in the HRQOL and PRO, on scale system for TCM, no direction in selecting scale, not standardizing in the design of the study with scale in the practice. So, it is necessary that the international guideline of developing scale applied for worldwide should be carried out in the study for developing scale. Meanwhile, it must also be under the guidance of TCM theory in the whole course. It will promote the normalization development of applying scale in the assessment of curative effect in the TCM practice.

  3. 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.

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

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

    2016-01-01

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

  6. Efficacy & safety evaluation of Ayurvedic treatment (Ashwagandha powder & Sidh Makardhwaj) in rheumatoid arthritis patients: a pilot prospective study

    PubMed Central

    Kumar, Gajendra; Srivastava, Amita; Sharma, Surinder Kumar; Rao, T. Divakara; Gupta, Yogendra Kumar

    2015-01-01

    Background & objectives: In the traditional system of medicine in India Ashwagandha powder and Sidh Makardhwaj have been used for the treatment of rheumatoid arthritis. However, safety and efficacy of this treatment have not been evaluated. Therefore, the present study was carried out to evaluate the efficacy and safety of Ayurvedic treatment (Ashwagandha powder and Sidh Makardhwaj) in patients with rheumatoid arthritis. Methods: One hundred and twenty five patients with joint pain were screened at an Ayurvedic hospital in New Delhi, India. Eighty six patients satisfied inclusion criteria and were included in the study. Detailed medical history and physical examination were recorded. Patients took 5g of Ashwagandha powder twice a day for three weeks with lukewarm water or milk. Sidh Makardhwaj (100 mg) with honey was administered daily for the next four weeks. The follow up of patients was carried out every two weeks. The primary efficacy end point was based on American College of Rheumatology (ACR) 20 response. Secondary end points were ACR50, ACR70 responses, change from baseline in disease activity score (DAS) 28 score and ACR parameters. Safety assessments were hepatic function [alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), bilirubin and ß2 microglobulin], renal function (urea and creatinine and NGAL) tests and urine mercury level. Results: The study was completed by 90.7 per cent (78/86) patients. Patients with moderate and high disease activity were 57.7 per cent (45/78) and 42.3 per cent (33/78), respectively. All patients were tested positive for rheumatoid factor and increased ESR level. Ashwagandha and Sidh Makardhwaj treatment decreased RA factor. A significant change in post-treatment scores of tender joint counts, swollen joint counts, physician global assessment score, patient global assessment score, pain assessment score, patient self assessed disability index score and ESR level were observed as

  7. 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

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

    ERIC Educational Resources Information Center

    Sariçoban, Arif; Behjoo, Bahram Mohammadi

    2016-01-01

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

  9. 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

  10. 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

  11. 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'…

  12. 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

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

    PubMed Central

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

    2016-01-01

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

  14. 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

  15. Prospective Evaluation of Ventriculostomy Infections

    PubMed Central

    Worley, Emmagene; Astle, Sonia

    2015-01-01

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

  16. 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

  17. [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

  18. A Multicenter, Prospective, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Saroglitazar 2 and 4 mg Compared with Placebo in Type 2 Diabetes Mellitus Patients Having Hypertriglyceridemia Not Controlled with Atorvastatin Therapy (PRESS VI)

    PubMed Central

    Pai, Vikas; Jha, Pramod; Jariwala, Gunjan; Mukhopadhyay, Satinath; Bhansali, Anil; Joshi, Shashank

    2014-01-01

    Abstract Background: Dyslipidemia due to diabetes is characterized by hypertriglyceridemia and reduced levels of high-density lipoprotein cholesterol (HDL-C) and elevated or normal levels of low-density lipoprotein cholesterol (LDL-C) in type 2 diabetes mellitus (T2DM). The objectives of this Phase III study were to evaluate the safety, tolerability, and efficacy of saroglitazar (ZYH1) 2-mg and 4-mg tablets (Lipaglyn™; Zydus Cadila, Ahmedabad, India) compared with placebo in patients with diabetic dyslipidemia who are not controlled with atorvastatin 10 mg therapy. Subjects and Methods: This was a 16-week prospective, multicenter, randomized, double-blind, placebo controlled, three-arm Phase III study in subjects with hypertriglyceridemia (>200 and <500 mg/dL) with T2DM not controlled with atorvastatin 10 mg. The study consisted of a run-in period of 4 weeks of life-style modification followed by 12 weeks of treatment with saroglitazar (2-mg or 4-mg) or placebo tablets. The primary end point was the change in plasma triglyceride level compared with baseline and the placebo arm at the end of Week 12. The secondary exploratory end points were change in lipid profile and fasting plasma glucose at Week 12. In total, 302 subjects were randomized to receive one of the treatments, saroglitazar 2 mg (n=101) or saroglitazar 4 mg (n=99), or matching placebo (n=102). Patients who received study medication and had undergone at least one post baseline efficacy evaluation were included in the efficacy analysis. Results: At Week 12, saroglitazar 2-mg and 4-mg tablets significantly reduced mean plasma triglyceride levels by −45.5±3.03% and −46.7±3.02% (mean±SE), respectively, and the difference was significant (P<0.001) compared with placebo. Saroglitazar 2 mg demonstrated significant decrease in levels of non-HDL-C, very LDL-C, total cholesterol, and fasting plasma glucose. Additionally, saroglitazar 4 mg also significantly reduced LDL-C and apolipoprotein

  19. 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…

  20. 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…

  1. 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…

  2. 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

  3. 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,…

  4. Perceived Efficacy Beliefs of Prospective Nigerian Science Teachers

    NASA Astrophysics Data System (ADS)

    Arigbabu, Abayomi A.; Oludipe, Daniel I.

    2010-02-01

    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 Instrument (STEB-B) (Enoch and Riggs in Sci Educ 74:625-638 1990). Results indicated that junior secondary preservice teachers were as efficacious as their senior secondary preservice teachers on the two dimensions of STEB-B. In addition, analyses did not reveal any significant gender differences on the two dimensions of STEB-B.

  5. 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…

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

    PubMed Central

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

    2014-01-01

    Dual PPARα/γ can improve both metabolic effects and minimized the side effects caused by either PPARα or PPARγ agonist. The PRESS V study was aimed to evaluate the safety, tolerability, and efficacy of saroglitazar 2 mg and 4 mg capsules (Lipaglyn™; Zydus Code: ZYH1) as compared to high dose pioglitazone in patients with diabetic dyslipidemia. In this 26-week double-blind, parallel arm, phase 3 study patients with hypertriglyceridemia with type 2 diabetes mellitus (BMI > 23 kg/m2; hypertriglyceridemia: TG > 200 to 400 mg/dL; glycosylated hemoglobin [HbA1c] >7 to 9%) were enrolled from 14 sites in India. After 2 weeks of lifestyle modification, 122 patients were randomized double-blind to 24-week treatment with the study drugs (saroglitazar 2 mg or 4 mg or pioglitazone 45 mg once daily) in a 1:1:1 ratio. The primary end point was change in plasma triglyceride level at week 24. The secondary end points were change in lipid profile and fasting plasma glucose at week 24. Patients who received study medication and had undergone at least 1 postbaseline efficacy evaluation were included in the efficacy analysis. All randomized patients who received at least a single dose were included for safety evaluation. The efficacy analysis included 109 patients (n = 37 in saroglitazar 2 mg; n = 39 in saroglitazar 4 mg; n = 33 in pioglitazone). Saroglitazar 2 mg and 4 mg significantly reduced (P < .001) plasma triglyceride from baseline by 26.4% (absolute change ± SD: −78.2 ± 81.98 mg/dL) and 45% (absolute change ± SD −115.4 ± 68.11 mg/dL), respectively, as compared to pioglitazone -15.5% (absolute change ± SD: −33.3 ± 162.41 mg/dL) at week 24. Saroglitazar 4 mg treatment also demonstrated marked decrease in low-density lipoprotein (5%), very-low-density lipoprotein (45.5%), total cholesterol (7.7%), and apolipoprotein-B (10.9%). Saroglitazar treatment was generally safe and well tolerated. No serious adverse events were reported in saroglitazar treatment arm and no

  7. 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

  8. [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

  9. A Prospective Evaluation of Helical Tomotherapy

    SciTech Connect

    Bauman, Glenn ||. E-mail: glenn.bauman@lhsc.on.ca; Yartsev, Slav; Rodrigues, George ||; Lewis, Craig; Hammond, Alex; Perera, Francisco; Ash, Robert, Dar, A. Rashid |; Venkatesan, Varagur M. |; Yu, Edward; Lock, Michael; Battista, Jerry; Van Dyk, Jake ||; Baily, Laura; Coad, Terry C; Trenka, Kris C.; Warr, Barbara; Kron, Tomas

    2007-06-01

    Purpose: To report results from two clinical trials evaluating helical tomotherapy (HT). Methods and Materials: Patients were enrolled in one of two prospective trials of HT (one for palliative and one for radical treatment). Both an HT plan and a companion three-dimensional conformal radiotherapy (3D-CRT) plan were generated. Pretreatment megavoltage computed tomography was used for daily image guidance. Results: From September 2004 to January 2006, a total of 61 sites in 60 patients were treated. In all but one case, a clinically acceptable tomotherapy plan for treatment was generated. Helical tomotherapy plans were subjectively equivalent or superior to 3D-CRT in 95% of plans. Helical tomotherapy was deemed equivalent or superior in two thirds of dose-volume point comparisons. In cases of inferiority, differences were either clinically insignificant and/or reflected deliberate tradeoffs to optimize the HT plan. Overall imaging and treatment time (median) was 27 min (range, 16-91 min). According to a patient questionnaire, 78% of patients were satisfied to very satisfied with the treatment process. Conclusions: Helical tomotherapy demonstrated clear advantages over conventional 3D-CRT in this diverse patient group. The prospective trials were helpful in deploying this technology in a busy clinical setting.

  10. 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…

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

    ERIC Educational Resources Information Center

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

    2016-01-01

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

  12. 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…

  13. 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

  14. An evaluation of the efficacy of different doses of ketamine for treatment of catheter-related bladder discomfort in patients underwent urologic surgery: A prospective, randomized, placebo-controlled, double-blind study

    PubMed Central

    Safavi, Mohammadreza; Honarmand, Azim; Atari, Mohammadali; Chehrodi, Shirin; Amoushahi, Mahsa

    2014-01-01

    Background: Urinary catheterization might have catheter-related bladder discomfort (CRBD). We evaluated the efficacy of different doses of ketamine in comparison to placebo as a treatment of CRBD. Materials and Methods: One hundred twenty patients who were candidate for urological surgery requiring catheterization of the urinary bladder were randomly divided into four groups including 30 patients in each. Group I received normal saline, Group II received ketamine 150 μg/kg/iv, Group III received ketamine 200 μg/kg/iv, and Group IV received 250 μg/kg/iv in the equal volume of 2 mL. The patients were observed for each 15 min in the recovery room and in the 1 h, 2 h, 6 h, 12 h, and 24 h after discharging from it for severity of CRBD and pain, levels of sedation, and post-operative nausea and vomiting. Results: The severity of CRBD at the recovery room was significantly reduced in Group III and Group IV after 24 h compared with Group I and Group II (P < 0.05). There was no significant difference between Group III and Group IV in this respect. The median sedation level was significantly lower in 15 min and 30 min after arrival to the recovery in Group III and Group IV compared with Group I and Group II (P < 0.05). There was no significant difference between Group III and Group IV in this regard. Conclusions: Ketamine 200 μg/kg/iv had similar efficacy with ketamine 250 μg/kg/iv in reducing the severity of CRBD without occurring significant side effect. PMID:24669123

  15. 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.

  16. 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

  17. 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

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

    PubMed Central

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

    2015-01-01

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

  19. Prospective study of vaginal dilator use adherence and efficacy following radiotherapy

    PubMed Central

    Law, Ethel; Kelvin, Joanne F.; Thom, Bridgette; Riedel, Elyn; Tom, Ashlyn; Carter, Jeanne; Alektiar, Kaled; Goodman, Karyn A.

    2016-01-01

    Background and purpose Vaginal stenosis (VS) after pelvic radiotherapy can impair long-term quality of life. We prospectively assessed adherence and efficacy of VD use as the primary and secondary objectives, respectively. Material and methods Women with gastrointestinal (n=63) and gynecologic (n=46) cancers self-reported use and VD size in monthly diaries for 12 months after radiotherapy. Adherence was measured as actual VD use out of recommended times over 12 months (3×/week × 52 weeks = 156). Results Among 109 participants, aged 28–81 years (median, 58 years), mean percent adherence over 12 months was 42% (95% confidence interval [CI], 36%–48%). Adherence was highest in the first quarter (56%), but fell to 25% by the fourth. Disease type, treatment sequence, and chemotherapy were predictors of adherence (all P<.05). Eighty-two percent maintained pre-RT VD size at 12 months; of 49% with decrease in VD size at 1 month post-RT, 71% returned to pre-RT VD size at 12 months. Disease type, younger age, and increased adherence at 6 months were associated with maintaining or returning to pre-RT size at 12 months (all P≤.05). Conclusions VD use is effective in minimizing VS, but adherence at 12 months was poor. Studies evaluating methods of improving adherence and determining the optimal frequency and duration of use are needed. PMID:26164775

  20. 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

  1. 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…

  2. Rufinamide efficacy and safety as adjunctive treatment in children with focal drug resistant epilepsy: the first Italian prospective study.

    PubMed

    Moavero, Romina; Cusmai, Raffaella; Specchio, Nicola; Fusco, Lucia; Capuano, Alessandro; Curatolo, Paolo; Vigevano, Federico

    2012-11-01

    Rufinamide is a new antiepileptic drug approved as add-on treatment in Lennox-Gastaut syndrome from the age of 4 years, and for the treatment of focal seizures in adults and adolescents. The aim of this prospective study was to evaluate the safety and efficacy of add-on Rufinamide in the treatment of childhood focal drug resistant epilepsy. We recruited 70 patients for a prospective, add-on, open-label study. Inclusion criteria were: 3 years of age or more; focal drug resistant epilepsy despite the use of three previous AEDs; use of at least one other AED, but no more than three at baseline; more than one seizure per month in the previous 6 months. Rufinamide efficacy was observed up to 12 months of follow-up, with a total responder rate of 38.57%. We found the best results in focal epilepsies due to structural/metabolic etiology (42.6%). The responder rate was similar for focal seizures with secondary generalization, simple focal seizures other than myoclonic jerks, and complex partial seizures. Response to Rufinamide was not related to the age. Our experience suggests that Rufinamide can be effective in reducing focal seizure frequency in children with drug resistant epilepsy, and that it can be considered as a safe drug. PMID:22677424

  3. 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…

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

    ERIC Educational Resources Information Center

    Aka, Elvan Ince

    2016-01-01

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

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

    ERIC Educational Resources Information Center

    Saka, Mehpare; Bayram, Hale; Kabapinar, Filiz

    2016-01-01

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

  6. 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…

  7. Self-efficacy, symptoms and physical activity in patients with an anterior cruciate ligament injury: a prospective study.

    PubMed

    Thomeé, P; Währborg, P; Börjesson, M; Thomeé, R; Eriksson, B I; Karlsson, J

    2007-06-01

    Self-efficacy belief may be of major importance for the outcome of rehabilitation after sports-related injuries. A new instrument, the Knee Self-Efficacy Scale (K-SES), was used to evaluate the role of perceived self-efficacy in patients with an anterior cruciate ligament (ACL) injury. The purpose of this prospective exploratory study was to describe the patients' perceived self-efficacy at various times post-injury and surgery, respectively, for responsiveness of the K-SES and to correlate the K-SES score with the patients' subjective symptoms. The purpose was also to describe the influence of gender, age and physical activity on the patients' perceived self-efficacy. Thirty recently injured patients with an ACL-deficient knee and 33 patients who had undergone ACL reconstruction reported their physical activity level and their perceived self-efficacy on four test occasions during a 1-year period. The patients' subjective knee symptoms were documented on two of the test occasions. A significant increase in the K-SES score was seen after injury as well as after surgery, during the course of rehabilitation. Pre-operatively, men's perceived self-efficacy was significantly (P=0.013) higher compared with women's self-efficacy. Patients with a high baseline (pre-injury) physical activity level (Tegner 7-10) perceived their self-efficacy as being significantly (P=0.005) higher pre-operatively compared with patients with a low baseline activity level (Tegner 3-6). "Younger" (age 17-29), recently injured patients, perceived their self-efficacy as being significantly (P=0.034) higher compared with "older" patients (age 30-54). At the 12-month test, 15 of 30 patients with an ACL-deficient knee and 15 of 33 patients who had undergone ACL reconstruction reported that they had returned or nearly returned to their baseline physical activity level. The subjective knee outcome score, as measured by the Knee Injury and Osteoarthritis Outcome Score (KOOS), improved significantly (P<0

  8. 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

  9. 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

  10. Efficacy of coblation annuloplasty in discogenic low back pain: a prospective observational study.

    PubMed

    He, Liangliang; Hu, Xiangyu; Tang, Yuanzhang; Li, Xiuhua; Zheng, Shuyue; Ni, Jiaxiang

    2015-05-01

    In degenerative disc, the innervated outer annulus is confirmed to the major origin resulted in discogenic pain. To alleviate the discogenic pain, annuloplasty with electrothermal technology was proved to be effective, which mainly involves the thermal heating of the annulus to denature collagen fibers and denervate posterior annular nerve fibers. However, little is known that efficacy of annuloplasty with coblation technology in treating discogenic pain through directly interrupting nerves in outer annulus.The purpose of this study was to evaluate the clinical outcomes of coblation annuloplasty for the treatment of discogenic low back pain.In a clinical prospective observational study, 17 consecutive patients with discogenic low back pain underwent coblation annuloplasty under local anesthesia. Pain visual analogue scale (VAS) scores, patient responses stating significant (≥50%) pain relief, and modified MacNab criteria were adopted to evaluate the pain intensity, degree of pain relief, and functional status after 6 months of follow-up.The preoperative pain VAS score was 6.5 ± 0.8(95% confidence interval [CI] 6.1-6.9) and the pain VAS score decreased to 2.9 ± 1.6 (95% CI 2.1-3.8), 2.9 ± 1.7 (95% CI 2.1-3.8), 3.2 ± 1.6 (95% CI 2.4-4.1), 3.2 ± 1.7 (95% CI 2.4-4.2) at 1 week and 1, 3 and 6 month postoperatively, respectively. 12 (70.6%), 11 (64.7%), 10 (58.8%) and 10 (58.8%) of patients reported significant pain relief at 1 week and 1, 3 and 6 months postoperatively. At 1, 3, and 6 months postoperatively, the numbers of patients with "excellent" or "good" ratings were 13 (76.5%), 11 (64.7%), and 10 (58.8%) according to the modified MacNab criteria. No serious complications were observed.The finds show that coblation annuloplasty is an effective, safe, and less uncomfortable procedure in managing discogenic low back pain.

  11. 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)…

  12. Multicenter, prospective, comparative cohort study evaluating the efficacy and safety of alfuzosin 10 mg with regard to blood pressure in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia with or without antihypertensive medications

    PubMed Central

    Zhang, Li Tao; Lee, Sung Won; Park, Kwangsung; Chung, Woo Sik; Kim, Sae Woong; Hyun, Jae Seog; Moon, Doo Geon; Yang, Sang-Kuk; Ryu, Ji Kan; Yang, Dae Yul; Moon, Ki Hak; Min, Kweon Sik; Park, Jong Kwan

    2015-01-01

    Background The objective of this study was to assess the efficacy and safety of alfuzosin 10 mg monotherapy or combined antihypertensive medication on blood pressure (BP) in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH/LUTS) with or without antihypertensive medication. Methods This was a 3-month, multicenter, randomized, open-label study in 335 patients aged ≥45 years with a clinical diagnosis of BPH/LUTS by medical history and clinical examination, a total International Prostatic Symptom Score (IPSS) ≥8 points, a maximum flow rate >5 mL/sec and ≤15 mL/sec, and a voided volume ≥120 mL. Eligible subjects were randomized to receive alfuzosin 10 mg as monotherapy (group 1) or alfuzosin 10 mg + antihypertensive combination therapy (group 2). Based on baseline BP and hypertensive history with or without antihypertensive medications at first medical examination, group 1 was divided into two subgroups of normotensive and untreated hypertensive patients, and group 2 into two subgroups of controlled hypertensive and uncontrolled hypertensive patients. The primary study outcomes were change in IPSS, BP, and heart rate from baseline. Secondary outcomes were change in IPSS-quality of life score, maximum flow rate, average flow rate, voided volume, and post-voided volume. Results The overall BP change was not significantly different between groups 1 and 2 (systolic BP, P=0.825; diastolic BP, P>0.999). In patients with uncontrolled or untreated hypertension, alfuzosin 10 mg alone or combined with antihypertensive therapy significantly decreased systolic and diastolic BP. The mean difference in total IPSS and IPSS-quality of life scores from baseline between groups 1 and 2 was 0.45 (95% CI: −1.26, 2.16) and 0.12 (95% CI: −0.21, 0.45), respectively (both P>0.05). Maximum flow rate, average flow rate, voided volume, and post-voided volume at endpoint were numerically, but not significantly, changed from baseline (all P>0

  13. 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

  14. 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.

  15. 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

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

    PubMed

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

    2006-01-01

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

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

    PubMed

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

    2016-06-30

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

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

    PubMed Central

    Bohl, Michael A; Oppenlander, Mark E

    2016-01-01

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

  20. 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…

  1. 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.

  2. Emotional Intelligence, Self-Efficacy, and Coping among Chinese Prospective and In-Service Teachers in Hong Kong

    ERIC Educational Resources Information Center

    Chan, David W.

    2008-01-01

    Emotional intelligence (intrapersonal and interpersonal) and general teacher self-efficacy were assessed to represent personal resources facilitating active and passive coping in a sample of 273 Chinese prospective and in-service teachers in Hong Kong. Intrapersonal emotional intelligence and interpersonal emotional intelligence were found to…

  3. 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…

  4. 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…

  5. 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

  6. 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…

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

    PubMed Central

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

    2008-01-01

    Consideration of reinforcer magnitude may be important for maximizing the efficacy of treatment for problem behavior. Nonetheless, relatively little is known about children's preferences for different magnitudes of social reinforcement or the extent to which preference is related to differences in reinforcer efficacy. The purpose of the current study was to evaluate the relations among reinforcer magnitude, preference, and efficacy by drawing on the procedures and results of basic experimentation in this area. Three children who engaged in problem behavior that was maintained by social positive reinforcement (attention, access to tangible items) participated. Results indicated that preference for different magnitudes of social reinforcement may predict reinforcer efficacy and that magnitude effects may be mediated by the schedule requirement. PMID:18595284

  8. Evaluating the Efficacy of Reading Fluency Education

    ERIC Educational Resources Information Center

    Harris, Eileen

    2010-01-01

    Students with weak reading skills are at risk for school difficulty. Among the indicators of reading difficulty, reading fluency is a strong predictor of overall reading problems. A multiple baseline design across small groups of students was used to evaluate the effects of explicit oral reading fluency instruction. Based on universal screening…

  9. 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

  10. 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.

  11. 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

  12. 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

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

    PubMed

    Millroth, Philip; Juslin, Peter

    2015-05-01

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

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

    PubMed

    Millroth, Philip; Juslin, Peter

    2015-05-01

    This study examines how numeracy and probability denominator (a direct-ratio probability, a relative frequency with denominator 100, a relative frequency with denominator 10,000) affect the evaluation of prospects in an expected-value based pricing task. We expected that numeracy would affect the results due to differences in the linearity of number perception and the susceptibility to denominator neglect with different probability formats. An analysis with functional measurement verified that participants integrated value and probability into an expected value. However, a significant interaction between numeracy and probability format and subsequent analyses of the parameters of cumulative prospect theory showed that the manipulation of probability denominator changed participants' psychophysical response to probability and value. Standard methods in decision research may thus confound people's genuine risk attitude with their numerical capacities and the probability format used. PMID:25704578

  15. 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…

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

    ERIC Educational Resources Information Center

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

    2013-01-01

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

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

    PubMed

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

    2016-05-01

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

  18. Treatment Efficacy of Electromyography versus Fiberscopy-Guided Botulinum Toxin Injection in Adductor Spasmodic Dysphonia Patients: A Prospective Comparative Study

    PubMed Central

    Kim, Jae Wook; Park, Jae Hong; Park, Ki Nam; Lee, Seung Won

    2014-01-01

    Introduction. This study prospectively evaluates and compares the treatment efficacy of botulinum toxin injection under electromyography guidance (EMG group) and percutaneous botulinum toxin injection under flexible fiberscopic guidance (fiberscopy group). Methods. Thirty patients with adductor spasmodic dysphonia (ADSD), who had never received treatment, were randomly allocated into EMG- or fiberscopy-guided botulinum toxin injections between March 2008 and February 2010. We assessed acoustic and aerodynamic voice parameters, and the voice handicap index (VHI) before injection and at 1, 3, and 6 months after injection. Results. The mean total dosage of botulinum toxin was similar for both groups: 1.7 ± 0.5 U for the EMG group and 1.8 ± 0.4 U for the fiberscopy group (P > 0.05). There were no significant differences in outcomes between the two groups in either the duration of effectiveness or complications such as breathy voice and aspiration. Conclusion. Botulinum toxin injection under fiberscopic guidance is a viable alternative to EMG-guided botulinum toxin injection for the treatment of adductor spasmodic dysphonia when EMG equipment is unavailable. PMID:25383369

  19. 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

  20. Efficacy Beliefs, Background Variables, and Differentiated Instruction of Israeli Prospective Teachers.

    ERIC Educational Resources Information Center

    Wertheim, Cheruta; Leyser, Yona

    2002-01-01

    Examined efficacy beliefs and choices of differentiated instructional strategies needed for effective teaching in inclusive classrooms. Israeli preservice teachers completed teacher efficacy scale and instructional strategy scales. Overall, personal teaching efficacy related to choice of instruction, but teaching efficacy did not. Participants…

  1. 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

  2. Evaluation of the Efficacy of Targeted Imaging Agents.

    PubMed

    Graham, Michael M; Weber, Wolfgang A

    2016-04-01

    This paper presents our adaptation of Fryback and Thornbury's hierarchical scheme for modeling the efficacy of diagnostic imaging systems. The original scheme was designed to evaluate new medical imaging systems but is less successful when applied to evaluate new radiopharmaceuticals. The proposed adaptation, which is specifically directed toward evaluating targeted imaging agents, has 6 levels: in vitro characterization, in vivo animal studies, initial human studies, impact on clinical care (change in management), impact on patient outcome, and societal efficacy. These levels, particularly the first four, implicitly define the sequence of studies needed to move an agent from the radiochemistry synthesis laboratory to the clinic. Completion of level 4 (impact on clinical care) should be sufficient for initial approval and reimbursement. We hope that the adapted scheme will help streamline the process and assist in bringing new targeted radiopharmaceuticals to approval over the next few years. PMID:26769867

  3. Evaluation of treatment efficacy in sleep apnea hypopnea syndrome.

    PubMed

    Sériès, F

    1996-11-01

    The evaluation of treatment efficacy consists in evaluating their efficacy to normalize sleep-related breathing disorders and neuropsychological consequences and witness complaints, patients' compliance, and the risk or side effects to benefits ratio. Polysomnographic studies are the gold standard for assessing the effects of treatments on nocturnal breathing the sleep characteristics, but the timing of control sleep studies must take into account the possible changes in treatment efficacy with time. Determining the effective positive pressure level during split nights or with a multifactorial regression model may be helpful but can result in an underestimation of the pressure setting. The utility of unassisted home sleep recordings during CPAP therapy is limited by the number of signals recorded and the absence of sleep recording. The evaluation of neuropsychological improvements has to be multifactorial to evaluate the subjective and objective effects of SAHS treatments. The compliance to CPAP therapy must be evaluated by pressure counter or time counter measurements rather than on the reported use. CPAP observance can be reliably estimated after the first month of therapy is linked to improvement in diurnal symptoms. As for any disease, SAHS treatment must be adapted to the individual characteristics of the patient and of his or her disease. Therefore, the choice between weight loss, pharyngeal or maxillomandibular surgery, anterior mandibular positioners or tongue retaining devices, nasal CPAP, BiPAP, and tracheostomy depends on the patient's complaints and morbidity risk factors and on the respective side effects to benefits ratio of these therapeutic procedures.

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

    PubMed

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

    2011-04-01

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

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

    PubMed Central

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

    2016-01-01

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

  6. 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

  7. Confirmatory Factor Analysis of the Teacher Efficacy Scale for Prospective Teachers

    ERIC Educational Resources Information Center

    Denzine, Gypsy M.; Cooney, John B.; McKenzie, Rita

    2005-01-01

    Background: Research on teacher self-efficacy has revealed substantive problems concerning the validity of instruments used to measure teacher self-efficacy beliefs. Although claims about the influence of teachers' self-efficacy beliefs on student achievement, success with curriculum innovation, and so on, may be true statements, one cannot make…

  8. 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…

  9. 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…

  10. 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

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

    PubMed Central

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

    2015-01-01

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

  12. 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

  13. Prospective evaluation of Foley catheter as a replacement gastrostomy tube.

    PubMed

    Kadakia, S C; Cassaday, M; Shaffer, R T

    1992-11-01

    Percutaneous endoscopic gastrostomy provides a nonsurgical alternative to enteral feeding. However, the percutaneous endoscopic gastrostomy tube may deteriorate, malfunction, or be accidentally expelled from the stomach, requiring replacement. This prospective study was performed to evaluate the use of an all silicone Foley catheter (Foley) as a replacement feeding gastrostomy in 28 patients requiring replacement gastrostomy. A plastic ring and a retention disc were always placed over the Foley prior to replacement. Foley functioned well without replacement in 19 (68%) patients for a mean of 167 days. It needed to be replaced in nine (32%) patients due to malfunction after a mean of 138 days. Lack of migration of Foley was the most striking finding of our study, in contrast to case reports in the literature. These data suggest that Foley can be safely used as replacement gastrostomy tube. A randomized controlled trial comparing the Foley catheter as a replacement tube with other commercially available devices is needed.

  14. 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…

  15. 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…

  16. 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…

  17. 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

  18. Safety and efficacy of long-term combination therapy with bezafibrate and ezetimibe in patients with dyslipidemia in the prospective, observational J-COMPATIBLE study

    PubMed Central

    2013-01-01

    Background There are numerous reports describing the efficacy of fenofibrate in combination with ezetimibe for treating dyslipidemia. In contrast, a study combining bezafibrate and ezetimibe has not yet been conducted. In this study, we examined the safety, including the risk of gallstone formation, and the efficacy of long-term combination therapy with bezafibrate and ezetimibe for treating dyslipidemia. Methods Dyslipidemic patients treated with 400 mg/day bezafibrate in combination with 10 mg/day ezetimibe for the first time were eligible. We selected 157 institutions in Japan and conducted a 12-month prospective observational study, with patients enrolled on the day they started combination therapy. Safety of the combination was examined in terms of the type, onset, and severity of adverse drug reactions (ADRs). Efficacy was evaluated in terms of the changes in low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C), triglyceride (TG), and non-HDL cholesterol (non-HDL-C) levels from the start of combination therapy (baseline) to the last observation carried forward (LOCF). Lipid levels were assessed at 1, 3, 6, and 12 months after starting combination therapy. Results We enrolled 665 patients in this observational study. Safety was evaluated in 659, and ADRs occurred in 42 patients (6.4%). The most frequent ADRs were blood creatine phosphokinase increase (1.5%) and myalgia (0.8%). Asymptomatic gallstones were observed in four patients (0.6%). Effectiveness was evaluated in 622 patients. LDL-C, HDL-C, TG, and non-HDL-C levels improved significantly from baseline to LOCF by −17.4%, 8.8%, –40.5%, and −21.6%, respectively (all, p < 0.001). Lipid levels also improved from baseline to each evaluation time-point. Conclusions Bezafibrate in combination with ezetimibe is safe and effective, and is potentially useful for comprehensive management of dyslipidemia. PMID:24195788

  19. 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

  20. 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.

  1. Safety and efficacy of laparoscopic cholecystectomy. A prospective analysis of 100 initial patients.

    PubMed

    Peters, J H; Ellison, E C; Innes, J T; Liss, J L; Nichols, K E; Lomano, J M; Roby, S R; Front, M E; Carey, L C

    1991-01-01

    Laparoscopic cholecystectomy quickly emerged as an alternative to open cholecystectomy. However its safety, efficacy, and morbidity have yet to be fully evaluated. During the first 6 months of 1990, we performed 100 consecutive laparoscopic cholecystectomies with no deaths and a morbidity rate of 8% (8 of 100 patients; 4 major, 4 minor). There were 81 women and 19 men, with a mean age of 46.1 years (range, 17 to 84 years). All patients had a preoperative history consistent with symptomatic biliary tract disease, and most had proved gallstones by sonography. This included four patients with acute cholecystitis. Mean operating time improved significantly from month 1 to month 6 (122 +/- 45.4 minutes versus 78.5 +/- 30 minutes, respectively), indicating a rapid learning curve. Mean hospital stay was 27.6 hours, reflecting a policy of overnight stay. Postoperative narcotic requirements were limited to oral or no medications in more than 70% of patients. A regular diet was tolerated by 83% of the patients by the morning following the procedure. Median time of return to full activity was 12.8 +/- 6.8 days after operation. In addition analysis of the hospital costs of these 100 cases demonstrates a modest cost advantage over standard open cholecystectomy (n = 58) (mean, $3620.25 +/- $1005.00 versus $4251.76 +/- $988.00). There was one minor bile duct injury requiring laparotomy and t-tube insertion, two postoperative bile collections, and one clinical diagnosis of a retained stone that passed spontaneously. Four patients required conversion to open cholecystectomy because of technical difficulties with the dissection. Although there is a significant learning curve, laparoscopic cholecystectomy is a safe and effective procedure that can be performed with minimal risk. Laparoscopic cholecystectomy should be performed by surgeons who are trained in biliary surgery and knowledgeable in biliary anatomy, and, as with all operations, it should be performed with meticulous

  2. Longitudinal interplay between posttraumatic stress symptoms and coping self-efficacy: A four-wave prospective study.

    PubMed

    Bosmans, Mark W G; van der Velden, Peter G

    2015-06-01

    Trauma-related coping self-efficacy (CSE), the perceived capability to manage one's personal functioning and the myriad environmental demands of the aftermath of potentially traumatic events (PTE), has been shown to affect psychological outcomes after these events. Aim of the present four-wave study was to examine the cross-lagged relationships between CSE and posttraumatic stress disorder (PTSD) symptoms following PTEs in order to examine direction of influence. Levels of CSE and PTSD symptoms were measured with 4-month intervals. In addition, prospectively assessed personality traits and general self-efficacy perceptions as well as peritraumatic distress were entered in the analyses. The study sample consists of adult respondents of a representative internet panel who experienced PTE in the six months before T1, and did not experience any new PTE or life event between T1 and T3 (N = 400). Respondents were administered the coping self-efficacy scale (CSE-7), impact of event scale (IES) and arousal items of IES-R at each wave (T1 through T3), as well as questions on peritraumatic stress and prospectively measured personality traits (T0). Results of structural equation modeling showed that the effect of CSE on subsequent PTSD symptom levels was dominant. CSE significantly predicted subsequent symptoms, over and above earlier symptom levels, with higher CSE associated with lower PTSD. Symptoms in turn, did not predict subsequent levels of CSE. Higher peritraumatic distress was associated with both higher initial PTSD symptoms and lower initial CSE levels. Higher levels of the personality traits of emotional stability and agreeableness were associated with higher initial CSE levels. This supports a model in which CSE perceptions play an important role in recovery from trauma.

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

    PubMed Central

    Bazhan, Sergei I.

    2016-01-01

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

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

    PubMed Central

    Bazhan, Sergei I.

    2016-01-01

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

  5. Adalimumab clinical efficacy is associated with rheumatoid factor and anti-cyclic citrullinated peptide antibody titer reduction: a one-year prospective study

    PubMed Central

    Atzeni, Fabiola; Sarzi-Puttini, Piercarlo; Dell' Acqua, Donata; de Portu, Simona; Cecchini, Germana; Cruini, Carola; Carrabba, Mario; Meroni, Pier Luigi

    2006-01-01

    Studies on autoantibody production in patients treated with tumor necrosis factor-α (TNF-α) inhibitors reported contradictory results. We investigated in a prospective study the efficacy of a treatment with human monoclonal anti-TNF-α antibody (adalimumab) in patients with rheumatoid arthritis (RA) and we evaluated the relationship between treatment efficacy and the incidence and titers of disease-associated and non-organ-specific autoantibodies. Fifty-seven patients with RA not responsive to methotrexate and treated with adalimumab were enrolled. Antinuclear, anti-double-stranded(ds)DNA, anti-extractable nuclear antigens, anti-cardiolipin (aCL), anti-β2 glycoprotein I (anti-β2GPI) autoantibodies, rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) autoantibodies were investigated at baseline and after 6 and 12 months of follow-up. Comparable parameters were evaluated in a further 55 patients treated with methotrexate only. Treatment with adalimumab induced a significant decrease in RF and anti-CCP serum levels, and the decrease in antibody titers correlated with the clinical response to the therapy. A significant induction of antinuclear autoantibodies (ANA) and IgG/IgM anti-dsDNA autoantibodies were also found in 28% and 14.6% patients, respectively, whereas aCL and anti-β2GPI autoantibodies were not detected in significant quantities. No association between ANA, anti-dsDNA, aCL and anti-β2GPI autoantibodies and clinical manifestations was found. Clinical efficacy of adalimumab is associated with the decrease in RF and anti-CCP serum levels that was detected after 24 weeks and remained stable until the 48th week of treatment. Antinuclear and anti-dsDNA autoantibodies, but not anti-phospholipid autoantibodies, can be induced by adalimumab but to a lower extent than in studies with other anti-TNF blocking agents. PMID:16356192

  6. Are Self-Efficacy Instruments Comparable to Knowledge and Skills Tests in Training Evaluation Settings?

    ERIC Educational Resources Information Center

    Lanigan, Mary L.

    2008-01-01

    Researchers have linked self-efficacy to performance, but they have not investigated the relationship between self-efficacy and knowledge and skills tests within a training evaluation setting, which is the main purpose of this study. Additionally, researchers have acknowledged self-efficacy scores may be distorted as a result of assessors…

  7. 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

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

    SciTech Connect

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

    1984-01-01

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

  9. 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.

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

    PubMed Central

    Bombardier, C; Maetzel, A

    1999-01-01

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

 PMID:10577979

  11. 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…

  12. 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)

  13. 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…

  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

    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

  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.

  17. 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

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

    PubMed

    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

  19. 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…

  20. 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

  1. [Thinking on the efficacy evaluation of TCM for treatment of heart failure].

    PubMed

    Wang, Yong-xia; Zhu, Ming-jun

    2008-12-01

    Through dissertating the current status and trend in efficacy evaluation of traditional and Western medicine for treatment of heart failure, aiming at the difference between TCM and Western medicine in efficacy evaluation and existent problems for diagnosis and treatment of heart failure. The authors proposed to establish a method for evaluating TCM clinical studies, a systematic method and thinking of indexes rating, depending upon the guidance of clinical methodologies of systematology, clinical epidemiology and evidence-based medicine, to make the efficacy evaluation founded upon the superiority of TCM and meeting to the international requisition, thus to facilitate the goingahead of TCM to the world.

  2. Efficacy of two gingival retraction systems on lateral gingival displacement: A prospective clinical study

    PubMed Central

    Anupam, Purwar; Namratha, N.; Vibha, Shetty; Anandakrishna, G.N.; Shally, Khanna; Singh, Amit

    2013-01-01

    Purpose Gingival management is a substantive procedure in fixed dental prosthesis treatment. Various new retraction cord systems are available and used. This study aimed to compare the efficacy of a new retraction cord (Stay-Put, Coltene Whaledent AG) and a conventional retraction cord (Ultrapak, Ultradent Products Inc., South Jordan, Utah) on lateral gingival displacement in continuation with the treatment protocol of the subjects fixed dental prosthesis for various partial edentulous conditions requiring fixed dental prosthesis. Method Thirty subjects were selected who needed bilateral fixed dental restoration. In selected subjects both gingival retraction cords were placed bilaterally buccolingually by simple randomization method. After removing the cords, impressions were made and undamaged definitive casts were retrieved. The abutment teeth were sectioned buccolingually at the buccal ridge followed by decimal measurement of the width (in millimeter) of the retracted gingival sulcus, under a traveling microscope. Results Data was analyzed using SPSS version. Paired "t" test was used to compare the difference between the displaced gingival width in two retraction group (p > 0.05). Conclusion Although mean gingival retraction in Stay-Put system (0.528 ± 0.12 mm) was higher as compared to that in Ultrapak (0.487 ± 0.10 mm), the difference between the two systems (0.041 ± 0.11) was not significant statistically (p = 0.057). PMID:25737887

  3. 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.

  4. Comparison of the efficacy of a subcutaneous array electrode with a subcutaneous patch electrode, a prospective randomized study.

    PubMed

    Kühlkamp, V; Dörnberger, V; Mewis, C; Seipel, L

    2001-05-01

    The patch electrode and the array electrode are the two types of subcutaneous leads available as an adjunct to a transvenous lead system in patients with high defibrillation thresholds. A prospective randomized study was conducted in 30 consecutive patients comparing the efficacy and the long-term performance of a patch electrode with an array electrode. After determination of the defibrillation threshold for the transvenous lead alone, a subcutaneous patch or an array electrode was implanted in random order. Adding a patch electrode decreased the defibrillation threshold in seven out of 15 patients (47%) from 13.2+/-6.6 to 10.5+/-5.1 J (P<0.05). In 13 out of 15 patients (87%), the implantation of an array electrode caused a significant lowering of the defibrillation threshold from 15.4+/-6.6 to 8.2+/-5.0 J (P<0.0001). The array electrode was significantly more effective in lowering the defibrillation threshold than the patch electrode (P<0.01). Complications during follow-up associated with the subcutaneous patch electrode were observed in four patients whereas no complications were associated with the array electrode (P<0.01). The additional implantation of an array electrode is more effective and associated with fewer complications compared to a patch electrode.

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

    PubMed

    Hsu, Pei-Yu; Yang, Sien-Hung; Tsang, Ngan-Ming; Fan, Kang-Hsing; Hsieh, Chia-Hsun; Lin, Jr-Rung; Hong, Ji-Hong; Lin, Yung-Chang; Chen, Hsing-Yu; Yang, Cheng-Tao; Yang, Ching-Wei; Chen, Jiun-Liang

    2016-01-01

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

  6. 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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed Central

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

    2016-01-01

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

  9. 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

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

    ERIC Educational Resources Information Center

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

    2011-01-01

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

  11. Self-Efficacy for Reading and Writing: Influence of Modeling, Goal Setting, and Self-Evaluation.

    ERIC Educational Resources Information Center

    Schunk, Dale H.

    2003-01-01

    Discusses theory, research, and applications relevant to one type of personal belief: perceived self-efficacy. Presents research evidence showing how social models, goal setting, and self-evaluation affect self-efficacy, motivation, and learning. Concludes with implications of the theory and research for educational practice. (SG)

  12. 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

  13. 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

  14. Evaluating Child Welfare Training in Public Agencies: Status and Prospects

    ERIC Educational Resources Information Center

    Collins, Mary Elizabeth

    2008-01-01

    Although staff training in public child welfare agencies is thought to be a critical component of effective practice, little is known about the delivery and effectiveness of training interventions. Few evaluations are published in the literature and it is uncertain how much evaluation activity is being conducted and utilized. This study collected…

  15. 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

  16. 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

  17. Digital venous angiography. A prospective evaluation in peripheral arterial trauma.

    PubMed Central

    Fabian, T C; Reiter, C B; Gold, R E; Pate, J W

    1984-01-01

    Digital venous angiography (DVA), a new radiographic technique, was prospectively compared to conventional intra-arterial angiography (CA) in a group of 153 patients with trauma and suspected peripheral arterial injury ( PAI ). Criteria for entry included: large hematoma, proximity to a major vessel, shotgun wounds, blunt injury of the extremities, and fractures or dislocations of areas with high risk of arterial injury. Patients with unequivocal clinical evidence of PAI were excluded. Study patients had both DVA and CA. Sixteen injuries were diagnosed: lacerations (9), transection (1), AV fistulae (2), thromboses (2) and minute intimal flaps (2). All patients with abnormal studies were surgically explored; there were no false-positives. There were no known false-negatives with CA. The intimal flaps were not recognized initially on DVA and their clinical significance is questioned. DVA, compared to CA in PAI , had decreased patient discomfort, cost, and morbidity. It has the potential for study of multiple areas of the body from a single I.V. catheter. DVA can probably replace CA for civilian penetrating wounds. CA may remain the standard for blunt and high velocity injuries. Images Fig. 1. Fig. 2. Fig. 3. Fig. 4. PMID:6375594

  18. 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

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

    PubMed

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

    2013-01-01

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

  20. 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

  1. Efficacy of the Revised NIOSH Lifting Equation to Predict Risk of Low-Back Pain Associated With Manual Lifting: A One-Year Prospective Study

    PubMed Central

    Lu, Ming-Lun; Waters, Thomas R.; Krieg, Edward; Werren, Dwight

    2015-01-01

    Objective The objective was to evaluate the efficacy of the Revised National Institute for Occupational Safety and Health (NIOSH) lifting equation (RNLE) to predict risk of low-back pain (LBP). Background In 1993, NIOSH published the RNLE as a risk assessment method for LBP associated with manual lifting. To date, there has been little research evaluating the RNLE as a predictor of the risk of LBP using a prospective design. Methods A total of 78 healthy industrial workers' baseline LBP risk exposures and self-reported LBP at one-year follow-up were investigated. The composite lifting index (CLI), the outcome measure of the RNLE for analyzing multiple lifting tasks, was used as the main risk predictor. The risk was estimated using the mean and maximum CLI variables at baseline and self-reported LBP during the follow-up. Odds ratios (ORs) were calculated using a logistic regression analysis adjusted for covariates that included personal factors, physical activities outside of work, job factors, and work-related psychosocial characteristics. Results The one-year self-reported LBP incidence was 32.1%. After controlling for history of prior LBP, supervisory support, and job strain, the categorical mean and maximum CLI above 2 had a significant relationship (OR = 5.1–6.5) with self-reported LBP, as compared with the CLI below or equal to 1. The correlation between the continuous CLI variables and LBP was unclear. Conclusions The CLI > 2 threshold may be useful for predicting self-reported LBP. Research with a larger sample size is needed to clarify the exposure–response relationship between the CLI and LBP. PMID:24669544

  2. Prospective evaluation of prognostic factors in operable breast cancer.

    PubMed Central

    Hawkins, R. A.; Tesdale, A. L.; Killen, M. E.; Jack, W. J.; Chetty, U.; Dixon, J. M.; Hulme, M. J.; Prescott, R. J.; McIntyre, M. A.; Miller, W. R.

    1996-01-01

    In 215 patients with operable breast cancer (T1-T3, N0-1, M0) and no other or previous cancer, presenting to a single breast unit, sufficient tumour was available for the prospective determination of four putative biochemical markers of prognosis: oestrogen receptor (ER) activity, cathepsin D (cath D), epidermal growth factor receptor (EGFR) activity and cyclic AMP-binding proteins (c-AMP-b). There were significant inter-relationships between ER and EGFR (r = -0.26), c-AMP-b and cath D (r = +0.32) and ER and c-AMP-b (r = +0.14). After follow-up (median 36.2 months), a total of 55 recurrences (18 locoregional only) and 35 deaths were recorded. By univariate analysis, up to 10 of 18 biochemical, clinical and histopathological variables of potential prognostic value were significantly related to disease-free interval or death, but by multivariate analysis only oestrogen receptor concentration and node status contributed significantly to risk of both distant recurrence/death; in addition, tumour size made a small contribution to the risk for a distant recurrence only. Only two parameters, tumour grade and ER concentration, were significantly related to risk of locoregional recurrence by univariate analysis, but by multivariate analysis, only tumour grade was important. It is concluded that tumour ER concentration, axillary nodal status and tumour grade remain as the most important prognostic factors in the early years after presentation of operable breast cancer, with a minor influence of tumour size. At this time, the prognostic significance of quantitative measurements of ER concentration, carefully controlled for the quality of both assay and tumour specimen, is probably greater than is generally appreciated. We have yet to identify other factors, which add significantly to the short-term prognostic value of these key features. PMID:8912547

  3. 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

  4. 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…

  5. 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

  6. Clinical Evaluation of Predictive Data for Prospective Home Economics Teachers.

    ERIC Educational Resources Information Center

    Gilbert, Ardyce Lucile

    This investigation, part of a longitudinal study of homemaking teacher effectiveness, was designed to explore the usefulness of clinical judgments to predict teacher success. Clinical judgment is defined as involving the ability to make sound decisions after gathering and evaluating all the pertinent evidence, weighing possible alternatives in…

  7. 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…

  8. 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…

  9. 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…

  10. 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

  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.

  12. 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

  13. 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

  14. 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

  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. 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…

  17. Prospective evaluation of mental health training for occupational health practitioners

    PubMed Central

    2013-01-01

    Background Occupational health (OH) practitioners need to be confident in identifying and managing mental health problems in the workforce. Aims To evaluate the effectiveness of a one-day workshop in improving the knowledge, attitude and confidence of OH practitioners in detecting and managing depression, anxiety, suicide risk, alcohol misuse and drug abuse. Methods Interactive mental health workshops for 164 OH practitioners held in five regions in England were evaluated by self-administered questionnaire. Data were collected immediately prior to the workshop (T1), immediately after the workshop (T2) and 4 months following the workshop (T3). Results At T1, the response rate was 97% (159/164), 90% at T2 and 63% at T3. The mean improvement in participants’ knowledge was 8% (95% CI 6–10) at T2 compared with T1. The biggest improvement was in participants with no previous training in the management of common mental health problems in the workplace, mean improvement 9% (95% CI 6–12). Participants’ confidence improved in all areas assessed at T2, and the improvement in confidence compared with that at baseline was sustained at 4 months (T3). Participants reported using the knowledge gained in clinical practice in all topic areas covered. Use of knowledge gained at the workshop was significantly higher in those who had had previous training in managing common mental health disorders. Conclusions This one-day interactive workshop was a feasible and effective method of improving OH professionals’ confidence, knowledge and application of skills in practice in key areas of mental health. PMID:23447034

  18. HIV prevention in Mexican schools: prospective randomised evaluation of intervention

    PubMed Central

    Walker, Dilys; Gutierrez, Juan Pablo; Torres, Pilar; Bertozzi, Stefano M

    2006-01-01

    Objective To assess effects on condom use and other sexual behaviour of an HIV prevention programme at school that promotes the use of condoms with and without emergency contraception. Design Cluster randomised controlled trial. Setting 40 public high schools in the state of Morelos, Mexico. Participants 10 954 first year high school students. Intervention Schools were randomised to one of three arms: an HIV prevention course that promoted condom use, the same course with emergency contraception as back-up, or the existing sex education course. Self administered anonymous questionnaires were completed at baseline, four months, and 16 months. Students at intervention schools received a 30 hour course (over 15 weeks) on HIV prevention and life skills, designed in accordance with guidelines of the joint United Nations programme on HIV/AIDS. Two extra hours of education on emergency contraception were given to students in the condom promotion with contraception arm. Main outcome measures Primary outcome measure was reported condom use. Other outcomes were reported sexual activity; knowledge and attitudes about HIV and emergency contraception; and attitudes and confidence about condom use. Results Intervention did not affect reported condom use. Knowledge of HIV improved in both intervention arms and knowledge of emergency contraception improved in the condom promotion with contraception arm. Reported sexual behaviour was similar in the intervention arms and the control group. Conclusion A rigorously designed, implemented, and evaluated HIV education course based in public high schools did not reduce risk behaviour, so such courses need to be redesigned and evaluated. Addition of emergency contraception did not decrease reported condom use or increase risky sexual behaviour but did increase reported use of emergency contraception. PMID:16682420

  19. 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

  20. 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.

  1. 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

  2. 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.

  3. 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

  4. 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.

  5. Nefazodone in psychotic unipolar and bipolar depression: a retrospective chart analysis and open prospective study on its efficacy and safety versus combined treatment with amitriptyline and haloperidol.

    PubMed

    Grunze, Heinz; Marcuse, Alain; Schärer, Lars O; Born, Christoph; Walden, Jörg

    2002-01-01

    Although atypical antipsychotics are on the rise, traditional treatment of psychotic (or delusional) depression mostly includes the addition of classical antipsychotics to antidepressants. As there are only few data supporting this approach compared with antidepressant monotherapy, and almost no data comparing it with antidepressants of the latest generation, we conducted a retrospective chart analysis and a prospective, randomized open study on the efficacy and tolerability of nefazodone monotherapy versus combined treatment with amitriptyline and haloperidol in psychotic depression. The results suggest that the addition of classical antipsychotics should be reserved for those with very severe psychotic symptoms, but may not be needed in milder forms.

  6. A laboratory hot tub model for disinfectant efficacy evaluation.

    PubMed

    Goeres, Darla M; Loetterle, Linda R; Hamilton, Martin A

    2007-01-01

    This paper describes a novel laboratory hot tub (LHT) apparatus and associated standard operating procedure (SOP) designed to reproduce the key biological, chemical, and engineering parameters associated with recreational and therapeutic hot tubs. Efficacy, as measured quantitatively by log reduction values, was determined against both biofilm and planktonic bacteria. When the LHT was run according to the SOP, with no antimicrobial treatment, a consistent level of bacterial contamination occurred. The means of log10 viable cell densities (+/- the repeatability standard deviation of log densities) were 7.2 (+/-0.31) for the bulk water (density in units of cfu ml-1), 5.3 (+/-0.56) for the coupons (density in units of cfu cm-2), and 6.6 (+/-0.50) for the filters (density in units of cfu cm-2). When control and chlorine treated LHTs were run in parallel, the log reduction increased significantly with chlorine concentration for samples of planktonic bacteria in the bulk water (p=0.016), biofilm bacteria on the coupons (p=0.09) and biofilm bacteria on the filter (p=0.005), indicating that the method was sensitive to chlorine concentration. The method also displayed sensitivity by differentiating between chlorine and bromine treatments; in every case, chlorine produced a greater log reduction than did the same concentration of bromine. The model and SOP were shown to be rugged with respect to slight changes in fluid mixing intensity, water chemistry (saturation index), inoculum size, and organic loading. The LHT and associated SOP provide a reliable second tier in a three-tiered testing process, in which the first tier is a suspension test and the final tier is a field test.

  7. 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

  8. 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.

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

    PubMed

    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.

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

    NASA Astrophysics Data System (ADS)

    Dawes, Mary Ellen

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

  11. Molecular Imaging to Plan Radiotherapy and Evaluate Its Efficacy.

    PubMed

    Jeraj, Robert; Bradshaw, Tyler; Simončič, Urban

    2015-11-01

    Molecular imaging plays a central role in the management of radiation oncology patients. Specific uses of imaging, particularly to plan radiotherapy and assess its efficacy, require an additional level of reproducibility and image quality beyond what is required for diagnostic imaging. Specific requirements include proper patient preparation, adequate technologist training, careful imaging protocol design, reliable scanner technology, reproducible software algorithms, and reliable data analysis methods. As uncertainty in target definition is arguably the greatest challenge facing radiation oncology, the greatest impact that molecular imaging can have may be in the reduction of interobserver variability in target volume delineation and in providing greater conformity between target volume boundaries and true tumor boundaries. Several automatic and semiautomatic contouring methods based on molecular imaging are available but still need sufficient validation to be widely adopted. Biologically conformal radiotherapy (dose painting) based on molecular imaging-assessed tumor heterogeneity is being investigated, but many challenges remain to fully exploring its potential. Molecular imaging also plays increasingly important roles in both early (during treatment) and late (after treatment) response assessment as both a predictive and a prognostic tool. Because of potentially confounding effects of radiation-induced inflammation, treatment response assessment requires careful interpretation. Although molecular imaging is already strongly embedded in radiotherapy, the path to widespread and all-inclusive use is still long. The lack of solid clinical evidence is the main impediment to broader use. Recommendations for practicing physicians are still rather scarce. (18)F-FDG PET/CT remains the main molecular imaging modality in radiation oncology applications. Although other molecular imaging options (e.g., proliferation imaging) are becoming more common, their widespread use is

  12. Hierarchical model for evaluating pyrantel efficacy against strongyle parasites in horses.

    PubMed

    Nielsen, M K; Vidyashankar, A N; Hanlon, B M; Diao, G; Petersen, S L; Kaplan, R M

    2013-11-01

    Anthelmintic resistance is an increasing challenge for the control of equine parasites. The fecal egg count reduction test (FECRT) is the practical gold standard method for evaluating reduction in anthelmintic efficacy, but the interpretation is complicated due to high levels of variability. A hierarchical statistical model was described for analysis of FECRT data from multiple farms to evaluate the role of biological factors in determining the strongyle efficacy of pyrantel pamoate in a study performed in Denmark. The model was then used to describe two notions of farm efficacy, namely conditional and marginal efficacy. The median of the lower prediction limits was used to describe a robust classification rule. The performance of the methodology was evaluated using Monte Carlo simulations. The field study was performed on 64 Danish horse farms of different breeds. Of 1644 horses, 614 had egg counts ≥ 200 eggs per gram (EPG) and were treated. Individual coprocultures were performed for identification of Strongylus vulgaris from all horses pre-treatment. Thirty-one farms (48.4%) were positive for S. vulgaris, but pyrantel efficacy was unaffected by the presence of this parasite in the statistical model. Further, there were no significant effects of age, gender, or interactions between these, while the pre-treatment egg count was negatively associated with the egg count reduction. The statistical model classified 81.3%, 10.9%, and 7.8% of farms as no signs of resistance (NR), suspect resistance (SR), and resistance (RE), respectively. In comparison, arithmetic calculations classified 68.8%, 17.2%, and 14.1% in the same categories. Using 10,000 simulated data sets, the methodology provided a classification of farms into different efficacy categories with a false discovery of reduced farm efficacy rate equaling 8.74%. In addition, model-classification was unaffected by presence of single outlier horses in a separate simulation study.

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

    PubMed Central

    Spreco, A; Timpka, T

    2016-01-01

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

  14. 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.

  15. 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.

  16. 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…

  17. Experimental Evaluation of Self-Efficacy Treatment on Technical/Scientific Career Outcomes.

    ERIC Educational Resources Information Center

    Dawes, Mary E.; Horan, John J.; Hackett, Gail

    A study evaluated experimentally a technology education program designed to provide mastery experiences described in Bandura's self-efficacy theory (1986) and predicted to improve career decision making. Seventh graders (n=97) and eighth graders (n=72) were stratified on grade level and randomly assigned either to a commercially published…

  18. Evaluating the Efficacy of Mathematics, Science and Technology Teacher Preparation Academies in Texas

    ERIC Educational Resources Information Center

    Brown, Danielle Bairrington; Alford, Beverly L.; Rollins, Kayla Braziel; Stillisano, Jacqueline R.; Waxman, Hersh C.

    2013-01-01

    The purpose of this mixed-methods study was to evaluate the efficacy of 14 Mathematics, Science and Technology Teacher Preparation (MSTTP) academies located across the state of Texas. The aim of the academies was to increase the number of highly qualified mathematics, science and technology teachers, while also improving the quality of certified…

  19. 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…

  20. 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…

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Commissioner of Food and Drugs from the National Academy of Sciences (1969).” As the report notes, this review... or submission or existence of adequate data), such qualification is not necessary. When the Food and... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Disclosure of drug efficacy study evaluations...

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Commissioner of Food and Drugs from the National Academy of Sciences (1969).” As the report notes, this review... or submission or existence of adequate data), such qualification is not necessary. When the Food and... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Disclosure of drug efficacy study evaluations...

  3. 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...

  4. 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).…

  5. 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…

  6. 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…

  7. Evaluation of the clinical efficacy of embryo cryopreservation.

    PubMed

    Schnorr, J A; Muasher, S J; Jones, H W

    2000-11-27

    To fully evaluate the advantages of a cryopreservation program a method needs to be established to express the additional patients pregnant from cryopreservation. The patient specific method considers cryopreservation as augmentation only among patients without a pregnancy from the fresh transfer, or from previously transferred frozen material from the same harvest. In an analysis of the pregnancy rate at the Jones Institute between January 1996 and December 1998 we found a fresh pregnancy rate of 40.8% in the good responders and 28.8% in poor responders. The patient specific pregnancy rate in the same cycles was 53.4% in good responders and 32.3% in poor responders. Good responders less than 35 years of age with ten or more mature eggs at retrieval had a fresh pregnancy rate of 40.2% and a patient specific pregnancy rate of 57.9%. It is exceedingly important for the physician and patient to understand and comprehend the potential in cryopreserved material.

  8. 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

  9. [Treatment of puerperal endometritis. Evaluation of the efficacy and safety of clindamycin + gentamycin vs. penicillin + chloramphenicol + gentamycin].

    PubMed

    Gutiérrez, C; Carrillo, C; Escudero, F; Caciano, S; García Hjarles, M

    1994-11-01

    This was a prospective, single-blind, comparative study in patients with diagnosis of puerperal endometritis, carried out at the Loayza Hospital in Lima, Peru. The objective of this study was to evaluate the efficacy and safety of clindamycin and gentamicin in the management of endometritis vs. penicillin, chloramphenicol and gentamicin for 10 days. Sixty-five patients were enrolled and 62 were evaluable for efficacy. Both treatment groups were comparable in the pre-treatment period in terms of age, history of pregnancies, controls by gynecologist, days of disease and fever, clinical symptoms like fever, pelvic pain, pulse, uterine size and in laboratory, in hematocrit and leukocytes count. In the culture of endometrium tissue, 27/32 patients (84.4%) in Group A (penicillin + CAF + gentamicin) and 27/30 patients (90%) in Group B (clindamycin + gentamicin) had positive cultures at baseline; 18 and 22 patients showed anaerobes; 8 and 4 patients showed anaerobes plus aerobes and, one patient in each treatment group showed aerobes only. Peptostreptococcus and Bacteroides fragilis were the most frequently isolated pathogens. Improvement in lochia fetidity was more rapid in Group B, it turned transparent and not fetid since day 3. Complete cure was significantly better in Group B 24/30 (80%) in comparison with Group A 16/32 (50%) (p = 0.02). Partial response was found in 15 patients (43.3%) in Group A and 5 patients (16.6%) in Group B. Only one case was considered as bacteriological failure in Group A and only one patient in Group B was considered as failure and required an additional operation due to residual abscess.(ABSTRACT TRUNCATED AT 250 WORDS) PMID:7821833

  10. 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.

  11. 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

  12. Analysis of blood pressure rhythms for drug efficacy evaluation.

    PubMed

    Germanò, G; Federico, L; Angotti, S; Codispoti, P; Muscolo, M; Bravo, S; Damiani, S

    1996-08-15

    This study analyzes some methods of evaluating the effects of antihypertensive drugs on blood pressure circadian rhythm. We reviewed four different approaches: hourly averages, trough-to-peak ratio, cosinor method, and Fourier series applied to the same data to prove the time course of the effects of isradipine administered once daily. A total of 141 patients of both sexes (mean age 53 years, range 30-76) with mild to moderate essential hypertension were enrolled in this multicenter trial after a 2-week placebo run-in. Treatment with isradipine SRO 5 mg/day administered between 8 and 9 AM was started. Each patient underwent ambulatory BP monitoring at the time of entry and after 6 weeks of treatment. Calculation of hourly averages showed decreases after 4 AM, and from about 8-9 AM, when the drug was administered, and the decreases practically did not vary until about 10 PM. Subsequently, the decreases became smaller and indicated reduced drug activity. However, this hypothesis no longer held after 4 AM. The trough-to-peak ratio was calculated including hourly averages after the dose divided by the lowest hourly average. Both systolic and diastolic blood pressure showed constant reduction from 3 PM (time of peak) to 11 PM. However, after 11 PM, higher trough-to-peak ratios paradoxically occurred due to a major reduction obtained with placebo, and the negative percentages just before the next dose cannot be attributed to treatment. Applying the cosinor method, maximal values were greatly underestimated, nocturnal values were overestimated, and the absolute maximum occurred in proximity to the minimum relating to postprandial dip. The generalized cosinor model, known as Fourier partial series, was always curtailed to the third harmonic. Fourier analysis was able to describe the daily trend of BP both before and after isradipine administration. We used statistical tests to determine if the differences described by the models were significant. The tests indicated

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

    PubMed

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

    2014-04-01

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

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

    PubMed

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

    2014-01-01

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

  15. 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.

  16. 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.

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed Central

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

    2016-01-01

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

  19. 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

  20. 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

  1. 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.

  2. 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

  3. Clinical evaluation of pediculicidal and ovicidal efficacy of two pyrethrin-piperonyl-butoxide formulations.

    PubMed

    Cordero, C; Zaias, N

    1987-01-01

    The pediculicidal and ovicidal efficacy of two pyrethrin-piperonyl-butoxide agents was evaluated in 40 children infested with head lice. Both commercial products, a lotion and a shampoo, had similar formulations. Specifically, the shampoo vehicle was tested to determine whether its surface-tension-lowering action made it more effective as an ovicidal agent than the lotion. Results of the study indicate that the shampoo is 49% more effective than the lotion as an ovicide.

  4. 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

  5. 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.

  6. Efficacy of CBT for benzodiazepine discontinuation in patients with panic disorder: Further evaluation.

    PubMed

    Otto, Michael W; McHugh, R Kathryn; Simon, Naomi M; Farach, Frank J; Worthington, John J; Pollack, Mark H

    2010-08-01

    Despite its acute efficacy for the treatment of panic disorder, benzodiazepines (BZs) are associated with a withdrawal syndrome that closely mimics anxiety sensations, leading to difficulty with treatment discontinuation and often disorder relapse. An exposure-based cognitive-behavioral treatment for BZ discontinuation, Panic Control Treatment for BZ Discontinuation (CBT) targets the fear of these sensations and has demonstrated efficacy in preventing disorder relapse and facilitating successful BZ discontinuation among patients with panic disorder. In this randomized controlled trial, CBT was compared to taper alone and a taper plus a relaxation condition to control for the effect of therapist contact and support among 47 patients with panic disorder seeking taper from BZs. Based on the primary outcome of successful discontinuation of BZ use, results indicate that adjunctive CBT provided additive benefits above both taper alone and taper plus relaxation, with consistently medium and large effect sizes over time that reached significance at the six month follow-up evaluation. The efficacy of CBT relative to either of the other taper conditions reflected very large and significant effect sizes at that time. These findings suggest that CBT provides specific efficacy for the successful discontinuation from BZs, even when controlling for therapist contact and relaxation training.

  7. 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

  8. 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

  9. 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.

  10. Prospective evaluation of analgesic use and risk of renal cell cancer

    PubMed Central

    Cho, Eunyoung; Curhan, Gary; Hankinson, Susan E.; Kantoff, Philip; Atkins, Michael B.; Stampfer, Meir; Choueiri, Toni K.

    2013-01-01

    Background Epidemiologic data suggest that analgesic use increases the risk of renal cell cancer (RCC), but few prospective studies exist. We investigated the association between analgesic use and RCC in two large prospective studies. Methods We examined the relation between analgesic use and RCC risk in the Nurses’ Health Study and the Health Professionals Follow-up Study. Use of aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs), and acetaminophen was ascertained in 1990 in the NHS and 1986 in the HPFS and every 2 years thereafter. We evaluated baseline and duration of use of analgesics. Results During follow-up of 16 years among 77,525 women and 20 years among 49,403 men, we documented 333 RCC cases. Aspirin and acetaminophen use were not associated with RCC risk. However, regular use of non-aspirin NSAIDs was associated with an increased RCC risk; the pooled multivariable relative risk (RR) was 1.51 (95% confidence interval [CI] 1.12–2.04) for the use at baseline. The absolute risk differences for the users vs. non-users of non-aspirin NSAIDs were 9.16/100,000 person-years in women and 10.92/100,000 person-years in men. There was a dose-response relation between duration of non-aspirin NSAIDs use and RCC risk; compared with non-regular users, the pooled multivariable RRs were 0.81 (95% CI 0.59–1.11) for use under 4 years, 1.36 (95% CI 0.98–1.89) for use 4–10 years, and 2.92 (95% CI 1.71–5.01) for use 10+ years (P for trend <0.001). Conclusions Our prospective data suggest that longer duration of use of non-aspirin NSAIDs may increase the risk of RCC. PMID:21911634

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

    PubMed

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

    2011-10-01

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

  12. Evaluation of antimicrobial efficacy of Aloe vera and its effectiveness in decontaminating gutta percha cones

    PubMed Central

    Athiban, Prakash P; Borthakur, Bikash Jyoti; Ganesan, S; Swathika, B

    2012-01-01

    Aim: The aim of this study was to evaluate the antimicrobial efficacy of Aloe vera and to determine its effectiveness in decontaminating gutta percha cones. Materials and Methods: A concentrated extract of Aloe vera was used to check for the antimicrobial efficacy using the agar well diffusion method. Presence of zones’ of diffusion was identified against three common GP contaminants namely, E.coli, E.faecalis and Staph. aureus. New GP Cones, freshly taken out of the packet were then decontaminated for 1minute using Aloe vera gel and then placed in thioglycolate broth to check for the presence of turbidity. Results: The zones of inhibition on the agar plate were measured as 24mm,21mm and 24mm respectively. The broth remained clear even after 48 hours of incubation. Conclusion: We conclude that Aloe vera is indeed effective as a GP decontaminant and it holds a promising future as a medium for storage of GP cones. PMID:22876011

  13. 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.

  14. [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

  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. 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

  17. A prospective evaluation of a novel implant designed for immediate loading.

    PubMed

    Amato, Francesco; Polara, Giorgio

    2014-01-01

    This prospective study evaluated the survival rate of immediately loaded anatomically tapered implants with a dual acid-etched, microtextured surface. Patients in a private practice were recruited for placement of 3i T3 tapered implants in single, multiple, and full-arch applications in the mandible and maxilla, in both fresh extraction and healed placement sites. Ninety patients were treated, and 240 implants were placed and immediately loaded: 124 in the maxilla and 116 in the mandible. One hundred twelve definitive prostheses were delivered between 4 and 6 months after implant placement. Over the course of 2 to 12 months of follow-up (mean: 4.8 months), five implants failed in the maxilla and no implants failed in the mandible, a survival rate of 96% for the maxilla and 100% for the mandible. The cumulative survival rate was 98%. PMID:24956090

  18. Antimicrobial stewardship: a review of prospective audit and feedback systems and an objective evaluation of outcomes.

    PubMed

    Chung, Gladys W; Wu, Jia En; Yeo, Chay Leng; Chan, Douglas; Hsu, Li Yang

    2013-02-15

    Antimicrobial stewardship is an emerging field currently defined by a series of strategies and interventions aimed toward improving appropriate prescription of antibiotics in humans in all healthcare settings. The ultimate goal is the preservation of current and future antibiotics against the threat of antimicrobial resistance, although improving patient safety and reducing healthcare costs are important concurrent aims. Prospective audit and feedback interventions are probably the most widely practiced of all antimicrobial stewardship strategies. Although labor-intensive, they are more easily accepted by physicians compared with formulary restriction and preauthorization strategies and have a higher potential for educational opportunities. Objective evaluation of antimicrobial stewardship is critical for determining the success of such programs. Nonetheless, there is controversy over which outcomes to measure and there is a pressing need for novel study designs that can objectively assess antimicrobial stewardship interventions despite the limitations inherent in the structure of most such programs.

  19. The chronic kidney disease self-efficacy (CKD-SE) instrument: development and psychometric evaluation

    PubMed Central

    Lin, Chiu-Chu; Wu, Chia-Chen; Anderson, Robert M.; Chang, Chao-Sung; Chang, Shu-Chen; Hwang, Shang-Jyh; Chen, Hung-Chun

    2012-01-01

    Background Self-management has been associated with positive health outcomes among adults with chronic kidney disease (CKD). Perceived disease-related self-efficacy (DSE) is considered a critical component in the successful self-management of chronic disease. A valid and reliable instrument for measuring CKD patients' self-efficacy is needed. This study aims to develop and test a new instrument to measure the DSE of patients with early stage CKD. Methods A total of 594 Taiwanese patients with early stage CKD recruited from two medical centers and one regional hospital in southern Taiwan completed the questionnaire. The CKD self-efficacy (CKD-SE) was evaluated using exploratory factor analyses (EFA) and measures of reliability. Results EFA identified four distinct factors with loadings ranging from 0.557 to 0.970: autonomy, self-integration, problem solving and seeking social support, accounting for 64.348% of the total variance. Cronbach's alpha coefficients for the subscales ranged from 0.843 to 0.901. Conclusion This promising 25-item CKD-SE instrument can be used for the early identification of patients with low DSE, thus allowing the development of interventions to help these patients attain an appropriate level of DSE. PMID:22344776

  20. 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

  1. Daily dosing prophylaxis for haemophilia: a randomized crossover pilot study evaluating feasibility and efficacy.

    PubMed

    Lindvall, K; Astermark, J; Björkman, S; Ljung, R; Carlsson, K S; Persson, S; Berntorp, E

    2012-11-01

    Regular replacement therapy (prophylaxis) for haemophilia has been shown to prevent development of disabling arthropathy and to provide a better quality of life compared to treatment on demand; however, at a substantially higher cost. Calculations based on pharmacokinetic principles have shown that shortening dose intervals may reduce cost. The aim of this prospective, randomized, crossover pilot study was to address whether daily dosing is feasible, if it reduces concentrate consumption and is as effective in preventing bleeding as the standard prophylactic dosing regimen. In a 12+12 month crossover study, 13 patients were randomized to start either their own previously prescribed standard dose, or daily dosing adjusted to maintain at least the same trough levels as obtained with the standard dose. Ten patients completed the study. A 30% reduction in cost of factor concentrates was achieved with daily prophylaxis. However, the number of bleeding events increased in some patients in the daily dosing arm and patients reported decreased quality of life during daily prophylaxis. Daily treatment had a greater impact on daily life, and the patients found it more stressful.Prophylaxis with daily dosing may be feasible and efficacious in some patients. A substantial reduction of factor consumption and costs can be realized, but larger studies are needed before the introduction of daily prophylaxis into clinical routine can be recommended.

  2. 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.

  3. Raman spectroscopic evaluation of efficacy of current paraffin wax section dewaxing agents.

    PubMed

    Faoláin, Eoghan O; Hunter, Mary B; Byrne, Joe M; Kelehan, Peter; Lambkin, Helen A; Byrne, Hugh J; Lyng, Fiona M

    2005-01-01

    During a spectroscopic study to identify biochemical changes in cervical tissue with the onset of carcinogenesis, residual paraffin wax contributions were observed on almost all dewaxed formalin-fixed paraffin-processed (FFPP) tissue sections examined. Subsequently, the present study was formulated to evaluate the efficacy of current dewaxing agents using Raman spectroscopy. Three cervical FFPP sections were subjected to each of the protocols. Sections were dewaxed using four common dewaxing protocols, namely, xylene, Histoclear, heat-mediated antigen retrieval (HMAR) using xylene and citrate buffer, and Trilogy (combined deparaffinization and unmasking of antigens). The potential for hexane as a dewaxing agent was also evaluated. Sections were dewaxed in multiple dewaxing cycles using xylene, Histoclear, and hexane. Residual paraffin wax contributions remained at 1062 cm(-1), 1296 cm(-1), and 1441 cm(-1). HMAR using xylene and citrate buffer, and HMAR using Trilogy, showed a similar efficacy, resulting in incomplete removal of wax. Hexane was shown to be the most effective dewaxing agent, resulting in almost complete removal of wax. Immunohistochemistry was carried out on dewaxed slides, and those dewaxed with hexane displayed a stronger positivity (approximately 28%). Implications for histopathology and immunohistochemistry are considered, as well as problems that residual wax poses for spectroscopic evaluation of dewaxed FFPP sections with a view to disease diagnosis.

  4. 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

  5. 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.

  6. Extracorporeal shock wave therapy for chronic painful heel syndrome: a prospective, double blind, randomized trial assessing the efficacy of a new electromagnetic shock wave device.

    PubMed

    Gollwitzer, Hans; Diehl, Peter; von Korff, Alexej; Rahlfs, Volker W; Gerdesmeyer, Ludger

    2007-01-01

    Published data describing the efficacy of extracorporeal shock wave therapy for the treatment of plantar heel pain provide conflicting results, and optimal treatment guidelines are yet to be determined. To assess the efficacy and safety of extracorporeal shockwave therapy compared with placebo in the treatment of chronic painful heel syndrome with a new electromagnetic device, we undertook a prospective, double-blind, randomized, placebo-controlled trial conducted among 40 participants who were randomly allocated to either active, focused extracorporeal shockwave therapy (0.25 mJ/mm(2)) or sham shockwave therapy. Both groups received 3 applications of 2000 shockwave impulses, each session 1 week apart. The primary outcome was the change in composite heel pain (morning pain, pain with activities of daily living, and pain upon application of pressure with a focal force meter) as quantified using a visual analog pain scale at 12 weeks after completion of the interventions compared with baseline. Secondary endpoints included changes in morning pain, pain with activities of daily living, and pain upon application of pressure with a focal force meter, as measured on a visual analog pain scale, as well as the change in the Roles and Maudsley score, at 12 weeks after the baseline measurement. Active extracorporeal shockwave therapy resulted in a 73.2% reduction in composite heel pain, and this was a 32.7% greater reduction than that achieved with placebo. The difference was not statistically significant (1-tailed Wilcoxon Mann-Whitney U test, P =.0302), but reached clinical relevance (Mann-Whitney effect size = 0.6737). In regard to the secondary outcomes, active extracorporeal shockwave therapy displayed relative superiority in comparison with the sham intervention. No relevant adverse events occurred in either intervention group. The results of the present study support the use of electromagnetically generated extracorporeal shockwave therapy for the treatment of

  7. Safety and efficacy of vardenafil versus sertraline in the treatment of premature ejaculation: a randomised, prospective and crossover study.

    PubMed

    Mathers, M J; Klotz, T; Roth, S; Lümmen, G; Sommer, F

    2009-06-01

    We investigated safety and efficacy of vardenafil and sertraline in premature ejaculation (PE). Seventy-two men graded their primary PE on a scale of 0-8 (0 = almost never, 8 = almost always). Intravaginal ejaculatory latency time (IELT) was measured. Patients were included if they scored their PE as 4 or greater and their IELTs were less than 1.30 min. After 6 weeks of behavioural psychosexual therapy, 49 patients still had a PE of 4 or greater and an IELT less than 1.30 min and they were randomised: 6 weeks vardenafil (10 mg) or sertraline (50 mg). After a wash-out phase for 1 week, medication was changed in a cross-over design. Initially, all 72 men with PE received behavioural therapy. Twenty-three men were satisfied with treatment and excluded. The remaining 49 men graded their PE as 5.94 +/- 1.6 and IELT was 0.59 min and patients were randomised. Four men discontinued the study. Vardenafil improved PE grading: 2.7 +/- 2.1 (P < 0.01) and IELT increased to 5.01 +/- 3.69 (P < 0.001). PE grading improved 1.92 +/- 1.32, (P < 0.01) and IELT 3.12 +/- 1.89 (P < 0.001) with sertraline. It is concluded that vardenafil and sertraline are useful agents in the pharmacological treatment of PE.

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

    PubMed

    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.

  9. 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

  10. Safety and efficacy of vardenafil versus sertraline in the treatment of premature ejaculation: a randomised, prospective and crossover study.

    PubMed

    Mathers, M J; Klotz, T; Roth, S; Lümmen, G; Sommer, F

    2009-06-01

    We investigated safety and efficacy of vardenafil and sertraline in premature ejaculation (PE). Seventy-two men graded their primary PE on a scale of 0-8 (0 = almost never, 8 = almost always). Intravaginal ejaculatory latency time (IELT) was measured. Patients were included if they scored their PE as 4 or greater and their IELTs were less than 1.30 min. After 6 weeks of behavioural psychosexual therapy, 49 patients still had a PE of 4 or greater and an IELT less than 1.30 min and they were randomised: 6 weeks vardenafil (10 mg) or sertraline (50 mg). After a wash-out phase for 1 week, medication was changed in a cross-over design. Initially, all 72 men with PE received behavioural therapy. Twenty-three men were satisfied with treatment and excluded. The remaining 49 men graded their PE as 5.94 +/- 1.6 and IELT was 0.59 min and patients were randomised. Four men discontinued the study. Vardenafil improved PE grading: 2.7 +/- 2.1 (P < 0.01) and IELT increased to 5.01 +/- 3.69 (P < 0.001). PE grading improved 1.92 +/- 1.32, (P < 0.01) and IELT 3.12 +/- 1.89 (P < 0.001) with sertraline. It is concluded that vardenafil and sertraline are useful agents in the pharmacological treatment of PE. PMID:19400851

  11. 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

  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. 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

  14. Clinical evaluation of the efficacy of methylnaltrexone in resolving constipation induced by different opioid subtypes combined with laboratory analysis of immunomodulatory and antiangiogenic effects of methylnaltrexone

    PubMed Central

    2014-01-01

    Background Opioid-induced constipation (OIC) is one of the major symptoms in palliative care with a prevalence of 30-50%. Methylnaltrexone for the treatment of OIC is significantly more effective than placebo, but only in about fifty percent of the patients regardless of dose increase. Dose increases cause increased toxicity without additional efficacy, and are therefore not recommended. While methylnaltrexone is a μ-receptor antagonist, only a few opioids are solely μ-receptor agonists. Therefore, the response to methylnaltrexone may be determined by the receptor-profile of a specific opioid. In addition, methylnaltrexone may also affect the immune system and angiogenesis as was found in pre-clinical studies. Primary aim of this study is to determine differences in the efficacy of methylnaltrexone prescribed to resolve opioid induced constipation between three commonly used opioid subtypes: morphine sulphate, oxycodone and fentanyl. Secondary aim is to explore potential immunomodulatory and antiangiogenic effects of methylnaltrexone. Methods In this multi-center, prospective, parallel group trial we will evaluate the efficacy of methylnaltrexone in resolving OIC occurring as a side effect of the most common opioid subtypes: morphine, oxycodone and fentanyl. In total 195 patients with OIC despite prophylactic laxatives will receive methylnaltrexone every other day up to fourteen days. Patients will report its effect in a laxation diary. Group allocation is based on the opioid type the patient is using. At the start and end of the study period patients complete the Bowel Function Index questionnaire. A subgroup of the patients will donate blood for analysis of immunomodulatory- and anti-angiogenic effects of methylnaltrexone. Discussion In this study we aim to determine the efficacy of methylnaltrexone per opioid subtype to reduce constipation. We expect that the outcome of this study will improve the clinical use of methylnaltraxone. Trial registration This trial

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

    PubMed Central

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

    2016-01-01

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

  16. Efficacy and tolerability of 1- and 3-month leuprorelin acetate depot formulations (Eligard®/Depo-Eligard®) for advanced prostate cancer in daily practice: a Belgian prospective non-interventional study

    PubMed Central

    Michielsen, Dirk

    2014-01-01

    Introduction The 1-, 3- and 6- month biodegradable polymer matrix depot formulations of leuprorelin acetate (Eligard®/Depo-Eligard®, Astellas Pharma Inc/BV) were shown to reduce testosterone and prostate-specific antigen levels and to be well tolerated in patients with advanced prostate cancer in several clinical trials. This study aimed at evaluating the efficacy, safety and tolerability of the 1- and 3-month leuprorelin acetate depot formulations in daily clinical practice. Material and methods A prospective, open-label, non-interventional, phase IV study (MANTA) was conducted in 243 Belgian prostate cancer patients who had been prescribed the 1-month (7.5 mg) or 3-month (22.5 mg) leuprorelin acetate depot formulation. Patients were followed for at least 3 months. Results Median serum prostate-specific antigen levels were reduced by 95% from 12.0 ng/ml at baseline to 0.60 ng/ml after a median follow-up time of 132 days, while median testosterone levels were reduced by 94% from 360 ng/dl to 20 ng/dl. Partial or complete treatment response was observed in 83% of patients at the final visit (according to the physician's assessment). Ninety-two patients (37.86%) experienced treatment-emergent adverse events, with injection site-related reactions, hot flushes and tumor flare being the most common ones. Overall safety and tolerability of the leuprorelin acetate depot formulation were rated as good or excellent by 90% of physicians. Conclusions These data are consistent with efficacy and tolerability results from clinical trials. They confirm that the 1- and 3-month leuprorelin acetate depot formulations are well tolerated and reliably lower serum prostate-specific antigen and testosterone levels in routine clinical practice. PMID:25097577

  17. 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

    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.

  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 and safety of escitalopram versus desvenlafaxine in the treatment of major depression: A preliminary 1-year prospective randomized open label comparative trial

    PubMed Central

    Gupta, Brij Mohan; Zargar, Samir H.; Arora, Manu; Tandon, Vishal R.

    2016-01-01

    Aim and Objective: To compare efficacy and safety of escitalopram with desvenlafaxine in the treatment of major depression. Materials and Methods: A total of 60 patients of depression were randomized into two groups after meeting inclusion criterion. In the first 3 weeks, escitalopram 10 mg/day was given and then 20 mg/day for the next 3 weeks in group 1 (n = 30). Desvenlafaxine in the first 3 weeks was given 50 mg/day and 100 mg/day for the next 3 weeks in group 2 (n = 30). The parameters evaluated during the study were efficacy assessments byHamilton Scale of Rating Depression (HAM-D), Hamilton Rating Scale of Anxiety (HAM-A), and Clinical Global Impression (CGI). Safety assessments were done by UKU-scale. Results: Escitalopram and desvenlafaxine significantly (P < 0.001), reduced HAM-D, HAM-A, and CGI scores from their respective base lines. However, on comparison failed show any statistical difference at 3 and 6 weeks of treatment. Escitalopram and desvenlafaxine were both found to be safe and well-tolerated and there was not much difference between the two groups as evident from UKU Scale and their effect on various biochemical parameters. Conclusion: The present study demonstrated similar efficacy and safety in reducing depression and anxiety with both escitalopram and desvenlafaxine, but clinical superiority of one drug over the other cannot be concluded due to limitations of the small sample size. PMID:26955576

  20. Comparative efficacy and tolerability of Ketomousse (ketoconazole foam 1%) and ketoconazole cream 2% in the treatment of pityriasis versicolor: results of a prospective, multicentre, randomised study.

    PubMed

    Di Fonzo, E M; Martini, P; Mazzatenta, C; Lotti, L; Alvino, S

    2008-11-01

    Ketomousse (K), a new thermophobic formulation (ketoconazole 1%), has proven its efficacy in the treatment of dandruff, caused by the same agent as pityriasis versicolor (PV). The objective of this study was to compare the efficacy and tolerability of K thermophobic foam vs. ketoconazole cream 2% (N) in the treatment of PV. Forty-six patients (22 in K and 24 in N group) with PV involving no more than 15% of the total trunk surface were randomly assigned for treatment either with K or N once daily for 14 days. Three weeks after the completion of treatment, improvement rate and side-effects were evaluated by clinical and mycological examination (Wood's light). Follow-up was available for 81% of subjects. Complete resolution was observed in five patients (29%) in K group and in nine (47%) in N group (P = 0.291). One patient in the N group reported urticaria while no adverse events were reported for K. Both products were cosmetically acceptable with respect to feasibility of application and formulation with a preference for K. Ketomousse (1% ketoconazole) provides an equal efficacy and tolerability compared to ketoconazole cream 2%. Therefore, Ketomousse could be considered an excellent therapeutic option in the treatment of PV. PMID:18422916

  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. 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.

  3. The efficacy and safety of nivolumab in previously treated advanced non-small-cell lung cancer: a meta-analysis of prospective clinical trials

    PubMed Central

    Huang, Jiaxing; Zhang, Yaxiong; Sheng, Jin; Zhang, Hongyu; Fang, Wenfeng; Zhan, Jianhua; Zhou, Ting; Chen, Ying; Liu, Lin; Zhang, Li

    2016-01-01

    Background Nivolumab (BMS-936558/ONO-4538) was the first monoclonal antibody targeting programmed death (PD)-1. So far, a number of clinical trials on nivolumab have showed satisfactory efficacy in treating non-small-cell lung cancer (NSCLC). Herein, we present a meta-analysis evaluating the efficacy and safety of nivolumab for previously treated advanced NSCLC patients. Methods Electronic databases were searched for eligible literature. Data of objective response rate (ORR), disease control rate, overall survival, progression-free survival, and adverse effects (AEs) were extracted and pooled. Outcomes analyzed and presented in this study were according to the original data from nivolumab 3 mg/kg. Results In general, nine trials with 817 patients were included in this meta-analysis. The pooled ORR, disease control rate, 1-year overall survival rate, and 1-year progression-free survival rate were 20% (95% confidence interval [CI]: 17%–23%), 36% (95% CI: 22%–51%), 47% (95% CI: 40%–53%), 21% (95% CI: 18%–24%), respectively. In addition, the rate of grade 3–4 AEs was only 8% (95% CI: 6%–12%). Subgroup analysis showed no significant difference in terms of ORR between squamous and non-squamous NSCLC (odds ratio 1.23, 95% CI: 0.63–2.39, P=0.51). However, significantly greater ORR was presented in programmed cell death ligand 1 (PD-L1) positive cohort (ORR 31%, 95% CI: 24%–38%), compared to PD-L1 negative cohort (ORR 12%, 95% CI: 9%–17%). The odds ratio for objective response to nivolumab in PD-L1 positive cases relative to negative cases was 3.08 (95% CI: 1.87–5.08, P<0.0001). Conclusion In conclusion, nivolumab is a promising second-line agent for previously treated advanced NSCLC with manageable AEs. Both squamous and non-squamous NSCLC patients showed similar efficacy. In addition, patients with positive PD-L1 expression had better response from nivolumab. Microabstract We present a meta-analysis evaluating the efficacy and safety of nivolumab for

  4. 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…

  5. 78 FR 42532 - Prospective Grant of Start-Up Exclusive Evaluation Option License: Methods of Treating Giardiasis...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-16

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Start-Up Exclusive Evaluation Option License: Methods of Treating Giardiasis Using Available Compounds AGENCY: National Institutes of...

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

    PubMed

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

    2013-10-01

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

  7. Evaluation of anti-cellulite efficacy: a topical cosmetic treatment for cellulite blemishes - a multifunctional formulation.

    PubMed

    Sparavigna, Adele; Guglielmini, Giancarlo; Togni, Stefano; Cristoni, Aldo; Maramaldi, Giada

    2011-01-01

    Cellulite is thought to affect 80-90% of postpubertal women, and is considered much of a cosmetic concern by the large majority of them. In this study, the objective was to assess the efficacy of a topical cosmetic product containing various active ingredients of botanical origin on cellulite blemishes on female volunteers affected by fat accumulations, as well as by slight-to-moderate cellulite in the lower limbs. The assessment was performed by means of various objective evaluations, including contact thermography, morphometric measures of thigh circumference, and microcirculation evaluation. The obtained results indicate that the use of synergistic botanical standardized extracts, through the exploitation of different mechanisms of action and acting on different biological targets, provides visible and measurable results in the improvement of cellulite signs and symptoms.

  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 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

  9. 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.

  10. Prospective evaluation of the learning curve of fertiloscopy with and without ovarian drilling.

    PubMed

    Franz, M; Ott, J; Watrelot, A; Küssel, L; Husslein, H

    2015-04-01

    Fertiloscopy represents an alternative to laparoscopy in the diagnostic evaluation of unexplained infertility or for the purpose of ovarian drilling. The learning curve of fertiloscopy in an experienced laparoscopic surgeon was evaluated in a prospective multicentre observational trial. A total of 110 fertiloscopies were carried out. At Centre 1, a beginner, and at Centre 2, an expert in fertiloscopy, performed the procedures. In three cases in Centre 1, and in 0 cases in Centre 2, the procedure was converted to transabdominal laparoscopy owing to intraoperative complications. Median operating time was longer at Centre 1 during the first 40 procedures (P < 0.001) and equal thereafter. Analyzing fertiloscopies with and without ovarian drilling separately, operating time was only longer for the first 20 procedures in each group (P < 0.001 and P = 0.002). In a multivariate analysis, intraoperative complications and fertiloscopy with ovarian drilling (compared with diagnostic fertiloscopy) were associated with longer duration of surgery (P < 0.001 for both parameters). An increasing consecutive number of fertiloscopies was associated with shorter duration of surgery (P < 0.001). Experienced laparoscopists should consider a transition towards fertiloscopy in the diagnostic workup of unexplained infertility or for the purpose of ovarian drilling.

  11. 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

  12. Prospective evaluation of an internet-linked handheld computer critical care knowledge access system

    PubMed Central

    Lapinsky, Stephen E; Wax, Randy; Showalter, Randy; Martinez-Motta, J Carlos; Hallett, David; Mehta, Sangeeta; Burry, Lisa; Stewart, Thomas E

    2004-01-01

    Introduction Critical care physicians may benefit from immediate access to medical reference material. We evaluated the feasibility and potential benefits of a handheld computer based knowledge access system linking a central academic intensive care unit (ICU) to multiple community-based ICUs. Methods Four community hospital ICUs with 17 physicians participated in this prospective interventional study. Following training in the use of an internet-linked, updateable handheld computer knowledge access system, the physicians used the handheld devices in their clinical environment for a 12-month intervention period. Feasibility of the system was evaluated by tracking use of the handheld computer and by conducting surveys and focus group discussions. Before and after the intervention period, participants underwent simulated patient care scenarios designed to evaluate the information sources they accessed, as well as the speed and quality of their decision making. Participants generated admission orders during each scenario, which were scored by blinded evaluators. Results Ten physicians (59%) used the system regularly, predominantly for nonmedical applications (median 32.8/month, interquartile range [IQR] 28.3–126.8), with medical software accessed less often (median 9/month, IQR 3.7–13.7). Eight out of 13 physicians (62%) who completed the final scenarios chose to use the handheld computer for information access. The median time to access information on the handheld handheld computer was 19 s (IQR 15–40 s). This group exhibited a significant improvement in admission order score as compared with those who used other resources (P = 0.018). Benefits and barriers to use of this technology were identified. Conclusion An updateable handheld computer system is feasible as a means of point-of-care access to medical reference material and may improve clinical decision making. However, during the study, acceptance of the system was variable. Improved training and new

  13. 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

  14. Laboratory evaluations of a toothbrush with diamond-shaped filaments for stiffness and efficacy.

    PubMed

    Yankell, S L; Shi, X; Emling, R C; Loudin, S; Homan, G; Nelson, C F

    2001-01-01

    The purpose of these studies was to evaluate four toothbrushes with a similar flat profile for stiffness and efficacy in removing artificial plaque deposits from interproximal areas, or depth of removal from broad tooth surfaces, and to relate these findings to bristle stiffness. The test toothbrush had 5-mil diameter, elongated diamond-shaped bristles (D). Three toothbrushes contained 5-mil (5), 6-mil (6), or 7-mil (7) diameter round bristles. Stiffness studies were performed using the ISO 8627 method. In the efficacy studies, toothbrushing was conducted with a vertical or horizontal brushing motion on simulated anterior or posterior teeth using a brushing weight of 250 g. The bristles were placed at a 90 degrees angle to the tooth surface, and brushing was performed for 15 seconds at two strokes per second with 50 mm strokes. Each of the toothbrush designs was tested 24 times. Interproximal access efficacy (IAE) was recorded as the maximum width of simulated plaque deposit removed. Depth of deposit removal (DDR) was determined using a color comparative scale, where 0 = no deposit change and 4 = maximum removal. The averages of wet and dry stiffness measurements were found to be 7 > D > 6 > 5; all values were in the range accepted as soft texture. The means for total IAE were ranked D > 5 > 6 > 7, and total DDR mean rankings were D > 7 > 6 > 5. For the round bristles, stiffness was inversely related to IAE and paralleled the DDR rankings. Using ANOVA, the D and 5-mil toothbrushes had significantly higher (p < 0.05) IAE means compared to the 6- or 7-mil products. The D toothbrush had significantly higher (p < 0.05) DDR means than the 5-mil product. The diamond-shaped bristles in these flat profile products resulted in improved depth of deposit removal compared to the same design with 5-mil round bristles.

  15. 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

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

    PubMed

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

    2015-12-01

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

  17. 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…

  18. 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…

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

    PubMed Central

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

    2015-01-01

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

  20. Evaluation of the protective efficacy of Vibrio cholerae ghost (VCG) candidate vaccines in rabbits.

    PubMed

    Eko, Francis O; Schukovskaya, Tatiana; Lotzmanova, E Y; Firstova, V V; Emalyanova, N V; Klueva, S N; Kravtzov, A L; Livanova, L F; Kutyrev, Vladimir V; Igietseme, Joseph U; Lubitz, Werner

    2003-09-01

    An effective Vibrio cholerae vaccine is needed to reduce the morbidity and mortality caused by this pathogen. Despite the availability of current oral vaccines with measurable efficacy, there is need for more effective vaccines with broad-spectrum efficacy in target populations. Recent studies have shown that bacterial ghosts, produced by the expression of cloned lysis gene E, possess adjuvant properties and are immunogenic. In this study, ghosts were prepared from V. cholerae O1 or O139 and evaluated as vaccines in the reversible intestinal tie adult rabbit diarrhea (RITARD) model. Rabbits were orally immunized with different doses of V. cholerae ghost (VCG) formulations. The vaccine formulations elicited high levels of serum vibriocidal titers against indicator strains. The magnitude of the response was measured as the geometric mean titer (GMT) increase for all rabbits in relation to prevaccination titers. The induction of cross protection was evidenced by the ability of serum from VCG-immunized rabbits to mediate complement-dependent killing of both the homologous and the heterologous strains. Immunized rabbits were protected against intraduodenal challenge 30 days after primary immunization. Protective immunity against challenge appeared to be dose dependent and was associated with marked inhibition of colonization. These results indicate that VCGs represent a novel approach to cholera vaccine development and constitute an effective vaccine delivery vehicle. PMID:12922096

  1. 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

  2. Field evaluation of the protective efficacy of Mycobacterium bovis BCG vaccine against bovine tuberculosis.

    PubMed

    Lopez-Valencia, G; Renteria-Evangelista, T; Williams, J de Jesús; Licea-Navarro, A; Mora-Valle, A De la; Medina-Basulto, G

    2010-02-01

    The protective efficacy of Mycobacterium bovis BCG (1 x 10(6) single dose) was evaluated under field conditions. A total of 140 male Holstein Friesian calves, one to two week-old were selected. Two groups of 70 each were formed, one group was vaccinated and the other was injected with a placebo during their second week of age and followed until 12 months of age. The study considered a positive case of tuberculosis to be an animal that had a positive reaction to the three following tests in a row: tuberculin, IFNgamma PPD-B and IFNgamma ESAT6-CFP10 during the 12 months of exposure. The results showed a 59.4% efficacy (IC95%: 47.64-71.16). The non-vaccinated calves were 2.4 times more at risk of becoming infected (IC95%: 1.07-5.68) compared to vaccinated animals. As a complementary test a PCR test was performed using nasal exudates in some animals from both groups using a Mycobacterium complex detection kit. All the positive PCR reactions (5/44) were found in the non-vaccinated animals. These findings suggest that the use of the BCG vaccine, even though it is not capable of protecting 100%, does prevent TB vaccinated animals from excreting bacilli in their nasal secretions at their first year of age.

  3. Randomised prospective study compares efficacy of five different stomach tubes for rumen fluid sampling in dairy cows.

    PubMed

    Steiner, S; Neidl, A; Linhart, N; Tichy, A; Gasteiner, J; Gallob, K; Baumgartner, W; Wittek, T

    2015-01-10

    The objective of the study was to compare the performance of five types of stomach tubes for rumen fluid sampling. Rumen fluid was sampled in rumen fistulated cows assigned to a 5×5 Latin square study design. The pH values of samples taken by stomach tubes and via fistulas were measured; the results were compared with indwelling sensor measurements. The practicability of the stomach tubes for regular use was tested in the field. Rumen fluid samples were obtained rapidly. Volumes for transfaunation could be obtained. The pH-values of samples taken with the four out of the five tubes (Dirksen, Geishauser, tube 4 and a simple water hose used with a gag) did not show significant differences to samples taken via rumen fistulas. Mean differences ranged between -0.02 and +0.09. Samples taken with tube 4 and the water hose showed also no significant differences to pH-sensor measurements. This study demonstrates that stomach tubes are suitable for rumen fluid sampling. Tube 4 seems to be the best probe for work in the field. It was well tolerated by the animals, saliva contamination is negligible. We, therefore, conclude that the evaluation of rumen acid base status in the field is possible.

  4. Visual function after penetrating keratoplasty for keratoconus: a prospective longitudinal evaluation

    PubMed Central

    Brahma, A.; Ennis, F.; Harper, R.; Ridgway, A.; Tullo, A.

    2000-01-01

    AIMS—To evaluate visual function and vision specific health status in patients undergoing penetrating keratoplasty for keratoconus.
METHODS—A prospective longitudinal study measuring logMAR visual acuity, contrast sensitivity, disability glare, binocular visual field, stereoacuity, and subjective visual function (VF-14) was conducted on 18 patients with keratoconus undergoing penetrating keratoplasty (PK), including six patients who had already had PK in the fellow eye. Data were collected preoperatively and at 3, 9, and 18 months after surgery.
RESULTS—Within 3 months of surgery there was significant improvement in aided visual acuity, contrast sensitivity, and stereoacuity (p<0.05); disability glare (p<0.05) no longer had a significant detrimental effect on these variables. VF-14 score improved significantly throughout the postoperative period (p<0.05). There was significant correlation of the VF-14 score with aided visual acuity, binocular visual field, and stereoacuity. Postoperative astigmatism (<4D v >4D) did not affect the VF-14 score significantly.
CONCLUSIONS—There is substantial and rapid improvement in visual function and vision specific health status in keratoconic patients as a result of uncomplicated penetrating keratoplasty.

 PMID:10611101

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2016-05-24

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

  9. 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

  10. 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

  11. 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.

  12. 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

  13. Evaluation of the efficacy of a specific hyperimmune serum in experimental influenza infection in mice.

    PubMed

    Marinescu, Bogdan; Coman, Cristin; Iancu, Adina Daniela; Stavaru, Crina; Lupulescu, Emilia; Onu, Adrian; Radu, Dorel Lucian

    2009-01-01

    Serotherapy still remains a way of treatment in some diseases, and it could be consider superior to any other mode of action because the protecting substances of the body are the products of the organism itself. The aim of the study was to establish an "in vivo" method for testing the efficacy of therapeutic serum. Hyperimmune serum for influenza A/PR8/34 viral strain, was prepared in sheep, and tested for inhibition of haemagglutination and microneutralisation. Seroprotection was evaluated in mice one day after being challenged with a lethal dose of the same virus. Our study shows that protection occurred in all mice treated with undiluted hyperimmune serum one day post infection (no clinical signs, faster recovery of the body weight after the first three days of the infection, all mice survived).

  14. A Prospective Evaluation of Survivorship of Asymptomatic Degenerative Rotator Cuff Tears

    PubMed Central

    Keener, Jay D.; Galatz, Leesa M.; Teefey, Sharlene A.; Middleton, William D.; Steger-May, Karen; Stobbs-Cucchi, Georgia; Patton, Rebecca; Yamaguchi, Ken

    2015-01-01

    Background: The purpose of this prospective study was to report the long-term risks of rotator cuff tear enlargement and symptom progression associated with degenerative asymptomatic tears. Methods: Subjects with an asymptomatic rotator cuff tear in one shoulder and pain due to rotator cuff disease in the contralateral shoulder enrolled as part of a prospective longitudinal study. Two hundred and twenty-four subjects (118 initial full-thickness tears, fifty-six initial partial-thickness tears, and fifty controls) were followed for a median of 5.1 years. Validated functional shoulder scores were calculated (visual analog pain scale, American Shoulder and Elbow Surgeons [ASES], and simple shoulder test [SST] scores). Subjects were followed annually with shoulder ultrasonography and clinical evaluations. Results: Tear enlargement was seen in 49% of the shoulders, and the median time to enlargement was 2.8 years. The occurrence of tear-enlargement events was influenced by the severity of the final tear type, with enlargement of 61% of the full-thickness tears, 44% of the partial-thickness tears, and 14% of the controls (p < 0.05). Subject age and sex were not related to tear enlargement. One hundred subjects (46%) developed new pain. The final tear type was associated with a greater risk of pain development, with the new pain developing in 28% of the controls, 46% of the shoulders with a partial-thickness tear, and 50% of those with a full-thickness tear (p < 0.05). The presence of tear enlargement was associated with the onset of new pain (p < 0.05). Progressive degenerative changes of the supraspinatus muscle were associated with tear enlargement, with supraspinatus muscle degeneration increasing in 4% of the shoulders with a stable tear compared with 30% of the shoulders with tear enlargement (p < 0.05). Nine percent of the shoulders with a stable tear showed increased infraspinatus muscle degeneration compared with 28% of those in which the tear had enlarged (p = 0

  15. 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

  16. Safety and efficacy of botulinum toxin type B for treatment of sialorrhea in Parkinson's disease: a prospective double-blind trial.

    PubMed

    Chinnapongse, Robert; Gullo, Kristen; Nemeth, Paul; Zhang, Yuxin; Griggs, Lynn

    2012-02-01

    Sialorrhea (drooling) is a common symptom of Parkinson's disease (PD) that can significantly impair a patient's health and quality of life. Fifty-four PD subjects with troublesome sialorrhea were enrolled using a multicenter, randomized, double-blind, sequential-dose escalation design in which subjects received a single intraglandular treatment with botulinum toxin type B (doses of 1,500 Units [0.3 mL]; 2,500 Units [0.5 ml]; or 3,500 Units [0.7 ml]) or placebo. Postinjection, subjects were followed acutely for 4 weeks and long-term for up to 20 weeks. Safety/tolerability, as assessed by adverse events, was the primary outcome measure. Efficacy, as assessed by the Drooling Frequency and Severity Scale and unstimulated salivary flow rate, was secondary. Gastrointestinal-related adverse events occurred more frequently in the active groups versus placebo group (31% vs 7%), with dry mouth being most common (15%). There were no serious adverse events attributed to botulinum toxin type B or discontinuations due to adverse events from treatment. At 4 weeks postinjection, Drooling Frequency and Severity Scale scores significantly improved versus placebo (-1.3 ± 1.3) in a dose-related manner (-2.1 ± 1.2, P = 0.0191; -3.3 ± 1.4, P < 0.0001; -3.5 ± 1.1, P < 0.0001, respectively) and unstimulated salivary flow rates significantly decreased in all active groups versus placebo (P ≤ 0.0009). Furthermore, treated subjects appeared to have more sustained improvement in sialorrhea than placebo subjects. We conclude that intraglandular injection of botulinum toxin type B was safe, tolerable, and efficacious in treating sialorrhea in PD patients. Additional studies are warranted to further confirm the drug's robust efficacy, as well as evaluate its effect with repeated dosing.

  17. 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

  18. 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

  19. 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.

  20. 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.

  1. 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

  2. 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…

  3. Laboratory evaluations of two battery-powered toothbrushes and a manual toothbrush for efficacy and safety.

    PubMed

    Yankell, Samuel L; Shi, Xiuren; Emling, Robert C; Blatz, Beverly; Biesbrock, Aaron R

    2002-01-01

    Two laboratory testing procedures, predictive of clinical efficacy and safety, have been used to evaluate two battery-powered toothbrushes (a new prototype, Crest SpinBrush Pro and a commercially available product, Crest SpinBrush) and a standard manual toothbrush (Oral-B Indicator). Interproximal access efficacy (IAE) and depth of deposit removal (DDR) have been evaluated in laboratory methods using pressure-sensitive paper placed around simulated anterior and posterior teeth at a brushing pressure of 250 g with horizontal or vertical brushing motions. Twenty-four tests on each toothbrush design were conducted, and results were statistically analyzed using ANOVA and the post hoc Tukey test. Both of the battery-powered toothbrushes had a significantly (p < 0.001) higher mean overall IAE value compared to the Oral-B Indicator product. The Crest SpinBrush Pro was significantly statistically higher (p < 0.05) compared to the Crest SpinBrush for mean overall IAE (access to interproximal spaces). On overall DDR, both of the powered toothbrushes had a significantly (p < 0.05-0.001) lower mean overall value compared to the Oral-B Indicator toothbrush (higher mean indicates higher irritation potential). Based on these results, both the new prototype Crest SpinBrush Pro and the commercially available Crest SpinBrush are predicted to be more effective clinically for plaque removal, and at least as safe on hard and soft intraoral tissues as the standard manual toothbrush (Oral-B Indicator) tested. In addition, the results support that the new prototype Crest SpinBrush Pro is more effective than the Crest SpinBrush with respect to IAE and predicted plaque removal.

  4. 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

  5. Evaluating and monitoring the efficacy of recombinant activated factor VIIa in patients with haemophilia and inhibitors.

    PubMed

    Qi, Xue; Zhao, Yongqiang; Li, Kuixing; Fan, Liankai; Hua, Baolai

    2014-10-01

    Although the use of bypassing agents has dramatically improved the management of haemophilia in patients with inhibitors, questions remain regarding optimal dosing regimens and methodology for monitoring their clinical effectiveness. In this study, we evaluated the efficacy and safety of two different doses of recombinant activated factor VIIa (rFVIIa) in patients with haemophilia and inhibitors and assessed the feasibility of using thromboelastography (TEG) and thrombin generation assays (TGA) for monitoring the response to rFVIIa. Six patients aged 9-49 years with congenital or acquired haemophilia with inhibitors who experienced a total of nine bleeding episodes were included. Seven episodes were treated with conventional rFVIIa dosing (72.7-109.1 μg/kg), and two episodes were treated with a single high-dose regimen (254.6-264.0 μg/kg). Clinical and haemostatic responses were evaluated. Haemostasis was assessed by prothrombin time (PT), activated partial thromboplastin time (aPTT), factor VII coagulant activity (FVII:C), TEG, and TGA. Six out of seven (85.7%) bleeding episodes responded to conventional rFVIIa dosing, and half (50%) responded to the high-dose regimen. No relationships between PT, aPTT, and FVII:C levels and clinical outcome were observed. However, changes in TEG and TGA parameters tended to correspond to clinical response, although large inter-individual variation in rFVIIa efficacy was noted. A good response was seen with rFVIIa in treating acute bleeding episodes in patients with haemophilia and inhibitors. Because changes in TEG and TGA may correlate with clinical outcomes of rFVIIa, TEG and TGA may be useful for monitoring rFVIIa activity in inhibitor-positive haemophilia.

  6. 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

  7. A Prospective Randomized Double Blind Placebo Controlled Trial on the Efficacy of Ethanol Celiac Plexus Neurolysis in Patients with Operable Pancreatic and Periampullary Adenocarcinoma

    PubMed Central

    Lavu, Harish; Lengel, Harry B; Sell, Naomi M; Baiocco, Joseph A; Kennedy, Eugene P; Yeo, Theresa P; Burrell, Sherry A; Winter, Jordan M; Hegarty, Sarah; Leiby, Benjamin E.; Yeo, Charles J

    2015-01-01

    Background Ethanol celiac plexus neurolysis (ECPN) has been shown to be effective in reducing cancer-related pain in patients with locally advanced pancreatic and periampullary adenocarcinoma (PPA). This study examined its efficacy in patients undergoing PPA resection. Study Design 485 patients participated in this prospective, randomized, double blind placebo controlled trial. Patients were stratified by preoperative pain and disease resectability. They received either ECPN (50% ethanol) or 0.9% normal saline placebo control. The primary endpoint was short and long-term pain and secondary endpoints included postoperative morbidity, QOL and overall survival. Results Data from 467 patients were analyzed. The primary endpoint, the percentage of PPA patients experiencing a worsening of pain compared to preoperative baseline for resectable patients, was not different between the ethanol and saline groups in either the resectable/pain stratum (22% vs 18%, RR 1.23 (0.34, 4.46)), or the resectable/no pain stratum (37% vs 34%, RR 1.10 (0.67, 1.81)). On multivariable analysis of resected pancreatic ductal adenocarcinoma (PDA) patients, there was a significant reduction in pain in the resectable/pain group, suggesting that surgical resection of the malignancy alone (independent of ECPN) decrements pain to a significant degree. Conclusions In this study, we have demonstrated a significant reduction in pain following surgical resection of PPA. However the addition of ECPN did not synergize to result in a further reduction in pain, and in fact its effect may have been masked by surgical resection. Given this, we cannot recommend the use of ECPN to mitigate cancer related pain in resectable PPA patients. PMID:25667135

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

    PubMed

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

    2015-08-01

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

  9. A prospective randomized trial of the antiemetic efficacy and cost-effectiveness of intravenous and orally disintegrating tablet of ondansetron in children with cancer.

    PubMed

    Corapçioglu, Funda; Sarper, Nazan

    2005-03-01

    Orally disintegrating tablet (ODT) of ondansetron is a new formulation, which instantaneously disintegrates and disperses in the saliva without need for ingestion of a liquid. This makes the formulation suitable for administration in children. The objective of this study was to compare the relative efficacy and cost of ODT and intravenous (IV) formulation of ondansetron in controlling nausea and vomiting in children receiving chemotherapy regimens without cisplatin. This prospective randomized trial was performed in a single institution to compare ODT and IV formulation of ondansetron for the prevention of acute emesis in a group of 22 children. Study agents were administered 30 min before chemotherapy and 12 hourly after chemotherapy (5 mg/m2 IV or 4-8 mg oral according to body surface area in 56 and 39 courses, respectively). After randomization, IV formulation was administered to some children instead of ODT due to unavailability of this formulation. Complete and major control of emesis was obtained in 92% of patients in the IV group and 93% of patients in the ODT group. In 56 courses with grade III-IV emetogenicity, complete response rates were not different between the two treatment arms. In the courses without corticosteroids complete response rates were not also different between the two arms. The mean costs per successfully controlled courses were 121.3 USD for the IV formulation whereas 63.2 USD for the ODT formulation. The results of this study confirmed that ODT formulation of ondansetron is a safe, well-tolerated, and cost-effective antiemetic for children during non-cisplatin-containing moderately and highly emetogenic chemotherapy.

  10. 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.…

  11. 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

  12. 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

  13. 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

  14. 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…

  15. 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

  16. 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 ...

  17. Is Collective Efficacy Age Graded? The Development and Evaluation of a New Measure of Collective Efficacy for Older Adults

    PubMed Central

    Galinsky, Adena M.; Cagney, Kathleen A.; Browning, Christopher R.

    2012-01-01

    Objectives. Community processes are key determinants of older adults' ability to age in place, but existing scales measuring these constructs may not provide accurate, unbiased measurements among older adults because they were designed with the concerns of child-rearing respondents in mind. This study examines the properties of a new theory-based measure of collective efficacy (CE) that accounts for the perspectives of older residents. Methods. Data come from the population-based Chicago Neighborhood Organization, Aging and Health study (N = 1,151), which surveyed adults aged 65 to 95. Using descriptive statistics, correlations, and factor analysis, we explored the acceptability, reliability, and validity of the new measure. Results. Principal component analysis indicated that the new scale measures a single latent factor. It had good internal consistency reliability, was highly correlated with the original scale, and was similarly associated with neighborhood exchange and disorder, self-rated health, mobility, and loneliness. The new scale also showed less age-differentiated nonresponse compared to the original scale. Discussion. The older adult CE scale has reliability and validity equivalent to that of the existing measure but benefits from a more developed theoretical grounding and reduced likelihood of age-related differential nonresponse. PMID:22315685

  18. 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

  19. 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.

  20. Prospective evaluation of serum glial fibrillary acidic protein (GFAP) as a diagnostic marker for glioblastoma.

    PubMed

    Tichy, Julia; Spechtmeyer, Sabrina; Mittelbronn, Michel; Hattingen, Elke; Rieger, Johannes; Senft, Christian; Foerch, Christian

    2016-01-01

    Glioblastoma (GBM) is the most common malignant primary brain tumor. Although clinical presentation and brain imaging might be suggestive, histopathological evaluation by means of a brain biopsy is routinely performed to establish the diagnosis. A serum marker indicative of GBM may simplify the diagnostic work-up of patients suspected to having a brain tumor. We prospectively examined 113 patients with newly diagnosed single supratentorial or infratentorial space-occupying brain lesions. Glial fibrillary acidic protein (GFAP) levels were determined from venous blood samples via a prototype ELISA assay prior to any invasive procedures. Serum levels of GFAP were correlated with histopathological findings and MRI parameters. GFAP values were significantly higher in GBM patients (n = 33) compared to all other tumors (p < 0.001). A GFAP serum concentration of ≥0.01 µg/L revealed a sensitivity of 85 % and a specificity of 70 % for differentiating GBM from other entities. By applying a GFAP cut-off point of 0.20 µg/L, specificity was maximized (99 %), but sensitivity dropped to 27 %. In GBM patients, serum GFAP values were significantly correlated with tumor volume. GBM patients with high GFAP levels showed more in vivo GFAP expression as well as more necrosis and perilesional edema compared to GBM patients having low or non-detectable GFAP levels. GFAP serum concentrations differentiated between patients with GBM and patients with cerebral mass lesions of other entities with a moderate diagnostic accuracy. Serum GFAP levels in GBM patients were positively correlated with tumor volume and histopathological tumor characteristics.

  1. 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.

  2. 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.

  3. 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.

  4. Neuroendocrine function following traumatic brain injury and subsequent intensive care treatment: a prospective longitudinal evaluation.

    PubMed

    Kleindienst, Andrea; Brabant, Georg; Bock, Christoph; Maser-Gluth, Christiane; Buchfelder, Michael

    2009-09-01

    Neuroendocrine dysfunction following traumatic brain injury (TBI) has been described extensively. However, few studies are longitudinal and most lack subtle radiological, clinical, and repetitive endocrine assessment in the acute phase. Accordingly, we prospectively assessed neuroendocrine function in 71 patients after TBI. Injury was documented by a computed tomography (CT). During the first week, critical clinical data (Glasgow Coma Score, APACHE score), treatment variables such as duration of analgosedation for mechanical ventilation, were related to basal pituitary function. More than 2 years later, a subgroup of patients was re-evaluated using dynamic testing with ACTH and GHRH-arginine tests. The Pearson's correlation analysis and Mann-Whitney rank sum test for group differences were used for statistical analysis. None of the CT findings predicted neuroendocrine dysfunction following TBI. The adaptive response to critical illness with significantly elevated cortisol levels on admission and decreased levels thereafter in patients ventilated for more than 24 h (p < 0.05) was attenuated following severe TBI (p < 0.05). However, the coincidence of low serum cortisol and increased urinary excretion of glucocorticoid metabolites in about 80% of patients challenges the relevance of basal hormone measurements. In ventilated patients, total T3 and free T4 were decreased (p < 0.05), TSH was low on day 3 (p < 0.05), and a gonadotropic insufficiency was present (p < 0.05). The thyrotropic and gonadotropic system recovered completely within the follow-up period. With regard to the somatotropic system, neither brain injury severity nor mechanical ventilation was associated with an insufficiency during the acute phase post-injury. However, initially low GH levels predicted a persistent deficiency (r = 0.731, p < 0.001). We conclude that both severe TBI and prolonged mechanical ventilation result in hormonal disturbances early after injury, suggesting a pathophysiological

  5. 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

  6. 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

  7. In vivo efficacy and bioavailability of lumefantrine: Evaluating the application of Pheroid technology.

    PubMed

    du Plessis, Lissinda H; Govender, Katya; Denti, Paolo; Wiesner, Lubbe

    2015-11-01

    The oral absorption of compounds with low aqueous solubility, such as lumefantrine, is typically limited by the dissolution rate in the gastro-intestinal tract, resulting in erratic absorption and highly variable bioavailability. In previous studies we reported on the ability of Pheroid vesicles to improve the bioavailability of poorly soluble drugs. In the present study a Pro-Pheroid formulation, a modification of the previous formulation, was applied to improve the solubility of lumefantrine after oral administration and compared to lumefantrine in DMSO:water (1:9 v/v) solution (reference solution). A bioavailability study of lumefantrine was conducted in a mouse model in fed and fasted states. When using the reference solution, the bioavailability of the lumefantrine heavily depended on food intake, resulting in a 2.7 times higher bioavailability in the fed state when compared to the fasted state. It also showed large between-subject variability. When formulated using Pro-Pheroid, the bioavailability of lumefantrine was 3.5 times higher as compared to lumefantrine in the reference solution and fasting state. Pro-Pheroid also dramatically reduced the effects of food intake and the between-subject variability for bioavailability observed with the reference. In vivo antimalarial efficacy was also evaluated with lumefantrine formulated using Pro-Pheroid technology compared to the reference solution. The results indicated that lumefantrine in Pro-Pheroid formulation exhibited improved antimalarial activity in vitro by 46.8%, when compared to the reference. The results of the Peters' 4-day suppressive test indicated no significant difference in the efficacy or mean survival time of the mice in the Pro-Pheroid formulation and reference test groups when compared to the positive control, chloroquine. These findings suggest that using the Pro-Pheroid formulation improves the bioavailability of lumefantrine, eliminates the food effect associated with lumefantrine as well

  8. 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.

  9. 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

  10. Comparative efficacy of nimesulide and ketoprofen on inflammatory events in third molar surgery: a split-mouth, prospective, randomized, double-blind study.

    PubMed

    Pouchain, E C; Costa, F W G; Bezerra, T P; Soares, E C S

    2015-07-01

    This study aimed to compare the effect of nimesulide and ketoprofen on inflammatory parameters related to the surgical removal of third molars. A split-mouth, prospective, randomized, double-blind study was conducted in patients undergoing removal of four third molars. Eighteen eligible patients were allocated to one of two groups to receive treatment two times a day with either ketoprofen 100 mg or nimesulide 100 mg for a period of 3 days. The rescue medication intake (number) and pain intensity were evaluated at 6, 12, 24, and 48 h, and at 7 days postoperatively. Swelling and maximum mouth opening were evaluated at 24 h, 72 h, and 7 days postoperatively. The peak pain score occurred at 6h after surgery in the nimesulide group and at 12h in the ketoprofen group. There was no statistically significant difference between the groups, although pain relief was observed after 48 h in the nimesulide group and after 7 days in the ketoprofen group. For each group, there was a statically significant difference in pain scores among the studied periods (P<0.0001). None of the patients required rescue medication. There was a statistically significant difference in maximum mouth opening between the preoperative and postoperative periods (P<0.0001). Ketoprofen and nimesulide were effective at controlling pain, swelling, and trismus after the surgical removal of third molars.

  11. 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

  12. 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.

  13. Sunscreens, skin photobiology, and skin cancer: the need for UVA protection and evaluation of efficacy.

    PubMed Central

    Gasparro, F P

    2000-01-01

    Sunscreens are ultraviolet radiation (UVR)-absorbing chemicals that attenuate the amount and nature of UVR reaching viable cells in the skin. They are selected and tested for their ability to prevent erythema. No sunscreen prevents photodamage, as it has been demonstrated that suberythemal doses of UVR cause a variety of molecular changes (including DNA damage) in these cells. Furthermore, the spectrum of UVR reaching viable cells is altered by topically applied sunscreen. In this review, the basic aspects of sunscreens and skin photobiology are reviewed briefly. Although there can be no question concerning the efficacy of sunscreens for the prevention of erythema, questions remain because of the possible cumulative effects of chronic suberythemal doses and the increased exposure of skin cells to longer UVR wavelengths. The current major issue surrounding sunscreens involves their ability to protect skin cells against the effects of UVA radiation. These UVA effects may be direct damage (base oxidations) or effects on the skin immune system, yet there is no uniformly accepted method for the evaluation of UVA protection. This review is focused primarily on the latter topic covering action spectra that implicate the need for UVA protection. In addition, in vivo and in vitro methods proposed for the evaluation of candidate sunscreen formulations of UVA protective ability are reviewed. Finally, revisions in the terminology used to describe the protection afforded by sunscreens are suggested. It is proposed that SPF ("sun" protection factor) be renamed "sunburn" protection factor and that "critical wavelength" be designated "long wave index." PMID:10698724

  14. 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

  15. 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…

  16. 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…

  17. Latent Profiles of Parental Self-Efficacy and Children's Multisource-Evaluated Social Competence

    ERIC Educational Resources Information Center

    Junttila, Niina; Vauras, Marja

    2014-01-01

    Background: The interrelation between mothers' parental self-efficacy (PSE) and their school-aged children's well-being has been repeatedly proved. The lack of research in this area situates mainly on the absence of fathers, non-existent family-level studies, the paucity of independent evaluators, and the use of global PSE estimates.…

  18. 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…

  19. 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…

  20. A Psychometric Evaluation of the Career Decision Self-Efficacy Scale with Korean Students: A Rasch Model Approach

    ERIC Educational Resources Information Center

    Nam, Suk Kyung; Yang, Eunjoo; Lee, Sang Min; Lee, Sang Hee; Seol, Hyunsoo

    2011-01-01

    The Career Decision Self-Efficacy Scale (CDSE) is one of the most frequently used in the field of career development and counseling. In this study, using the Rasch rating scale model analysis, the CDSE Scale was evaluated by the content, structural, and substantive aspects of validity in a sample of college students from South Korea. Overall, the…

  1. 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…

  2. 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…

  3. Use of cotton rats to evaluate the efficacy of antivirals in treatment of measles virus infections.

    PubMed

    Wyde, P R; Moore-Poveda, D K; De Clercq, E; Neyts, J; Matsuda, A; Minakawa, N; Guzman, E; Gilbert, B E

    2000-05-01

    No practical animal models for the testing of chemotherapeutic or biologic agents identified in cell culture assays as being active against measles virus (MV) are currently available. Cotton rats may serve this purpose. To evaluate this possibility, 5-ethynyl-1-beta-D-ribofuranosylimidazole-4-carboxamide (EICAR) and poly(acrylamidomethyl propanesulfonate) (PAMPS), two compounds that have been reported to inhibit MV in vitro, and ribavirin, an established antiviral drug with MV-inhibitory activity, were evaluated for their antiviral activities against MV and respiratory syncytial virus (RSV) in tissue culture and in hispid cotton rats. A single administration of PAMPS markedly inhibited pulmonary RSV or MV replication (>3 log(10) reduction in pulmonary titer compared to that for controls), but only if this compound was administered intranasally at about the time of virus inoculation. Both EICAR and ribavirin exhibited therapeutic activity against RSV and MV in cotton rats when they were administered parenterally. However, both of these compounds were less effective against MV. On the basis of the pulmonary virus titers on day 4 after virus inoculation, the minimal efficacious dose of EICAR against MV (120 mg/kg of body weight/day when delivered intraperitoneally twice daily) appeared to be three times lower against this virus than that of ribavirin delivered at a similar dose (i.e., 360 mg/kg/day). These findings correlated with those obtained in vitro. The data obtained suggest that cotton rats may indeed be useful for the initial evaluation of the activities of antiviral agents against MV.

  4. 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).

  5. 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

  6. [Thinking and methods concerning applying data-mining technique in clinical efficacy evaluation of TCM treatment for child's pneumonia].

    PubMed

    Wang, Xue-feng; Dong, Dan; Liang, Mao-xin

    2007-10-01

    TCM syndrome differentiation system (TCM-SDS) possesses a complex nonlinear characteristic, which determines the falt that the evaluation of TCM efficacy should not be simplified to a causal or linear relationship. Previous selected indexes and methods for evaluating curative effect of Child's pneumonia have their limitations. This paper mainly introduces several thoughts and methods formed in the exploratory researches, employing data mining technology in this field. We believe that efficacy evaluation research of Child's pneumonia on the basis of standardized study of TCM-SDS is a scientific work. Applying data mining method in processing enormous and multilayer information of TCM differentiation has strong advantages in screening evaluating indexes of Child's pneumonia. Meanwhile, some major concerning technical categorizations and implementing strategies for the research are also introduced.

  7. Efficacy, safety and pharmacokinetic of once-daily boosted saquinavir (1500/100 mg) together with 2 nucleos(t)ide reverse transcriptase inhibitors in real life: a multicentre prospective study

    PubMed Central

    2010-01-01

    Background Ritonavir-boosted saquinavir (SQVr) is nowadays regarded as an alternative antiretroviral drug probably due to several drawbacks, such as its high pill burden, twice daily dosing and the requirement of 200 mg ritonavir when given at the current standard 1000/100 mg bid dosing. Several once-daily SQVr dosing schemes have been studied with the 200 mg SQV old formulations, trying to overcome some of these disadvantages. SQV 500 mg strength tablets became available at the end of 2005, thus facilitating a once-daily regimen with fewer pills, although there is very limited experience with this formulation yet. Methods Prospective, multicentre study in which efficacy, safety and pharmacokinetics of a regimen of once-daily SQVr 1500/100 mg plus 2 NRTIs were evaluated under routine clinical care conditions in either antiretroviral-naïve patients or in those with no previous history of antiretroviral treatments and/or genotypic resistance tests suggesting SQV resistance. Plasma SQV trough levels were measured by HPLV-UV. Results Five hundred and fourteen caucasian patients were included (47.2% coinfected with hepatitis C and/or B virus; 7.8% with cirrhosis). Efficacy at 52 weeks (plasma RNA-HIV <50 copies/ml) was 67.7% (CI95: 63.6 - 71.7%) by intention-to-treat, and 92.2% (CI95: 89.8 - 94.6%) by on-treatment analysis. The reasons for failure were: dropout or loss to follow-up (18.4%), virological failure (7.8%), adverse events (3.1%), and other reasons (4.6%). The high rate of dropout may be explained by an enrollement and follow-up under routine clinical care condition, and a population with a significant number of drug users. The median SQV Cmin (n = 49) was 295 ng/ml (range, 53-2172). The only variable associated with virological failure in the multivariate analysis was adherence (OR: 3.36; CI95, 1.51-7.46, p = 0.003). Conclusions Our results suggests that SQVr (1500/100 mg) once-daily plus 2 NRTIs is an effective regimen, without severe clinical adverse

  8. 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

  9. 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.

  10. Efficacy and safety of thalidomide for the treatment of severe recurrent epistaxis in hereditary hemorrhagic telangiectasia: results of a prospective phase II clinical trial

    PubMed Central

    Invernizzi, Rosangela; Quaglia, Federica; Klersy, Caherine; Pagella, Fabio; Ornati, Federica; Chu, Francesco; Matti, Elina; Spinozzi, Giuseppe; Plumitallo, Sara; Grignani, Pierangela; Olivieri, Carla; Bastia, Raffaella; Bellistri, Francesca; Danesino, Cesare; Benazzo, Marco; Balduini, Carlo L

    2016-01-01

    Summary Background Hereditary hemorrhagic telangiectasia (HHT) is a genetic disease that leads to multiregional angiodysplasia. Severe recurrent epistaxis is the most common presentation, frequently leading to severe anemia. Multiple therapeutic approaches have been tried, but they are largely palliative with variable results.We aimed to assess the efficacy of thalidomide in reducing epistaxis in patients with HHT refractory to standard therapy. Methods HHT patients with severe recurrent epistaxis refractory to mini-invasive surgical procedures were included in an open label, phase II, prospective, non-randomized, single-centre study. Thalidomide was administered at a starting dose of 50 mg/day orally. In the event of no response, thalidomide dosage was increased by 50 mg/day every four weeks until response to a maximum dose of 200 mg/day. After response achievement, patients were treated for eight to16 additional weeks. Monthly follow-up was based on the epistaxis severity score and transfusion need, with adverse events being reported (ClinicalTrials.gov Identifier: NCT01485224). Findings Thirty-one patients, mean age 62∙6 (SD 11∙1) years, were enrolled (median follow-up 15∙9 months, 25th-75th 10∙1-22∙3). Treatment induced cessation of bleeding in three cases (9∙7%) and a significant decrease in all epistaxis parameters in 28 cases (90∙3%). Twenty-five patients (80∙7%) obtained remission with 50 mg/day of thalidomide, five (16∙1%) with 100 mg/day and one (3∙2%) with 150 mg/day. Treatment significantly increased hemoglobin levels (p<0∙001), and abolished or greatly decreased the transfusion need (p<0∙001).Only nonserious, grade I, adverse effects were observed, including constipation and drowsiness. Median time to relapse after the end of therapy was 6∙4 months. No correlation was found between genetic or clinical features and response to thalidomide or toxicity. Interpretation Low-dose thalidomide is safe and very effective in reducing

  11. Infliximab therapy for intestinal, neurological, and vascular involvement in Behcet disease: Efficacy, safety, and pharmacokinetics in a multicenter, prospective, open-label, single-arm phase 3 study

    PubMed Central

    Hibi, Toshifumi; Hirohata, Shunsei; Kikuchi, Hirotoshi; Tateishi, Ukihide; Sato, Noriko; Ozaki, Kunihiko; Kondo, Kazuoki; Ishigatsubo, Yoshiaki

    2016-01-01

    Abstract Behçet disease (BD) is a multisystem disease associated with a poor prognosis in cases of gastrointestinal, neurological, or vascular involvement. We conducted a multicenter, prospective, open-label, single-arm phase 3 study to determine the efficacy, safety, and pharmacokinetics of infliximab (IFX) in BD patients with these serious complications who had displayed poor response or intolerance to conventional therapy. IFX at 5 mg/kg was administered to 18 patients (11 intestinal BD, 3 neurological BD [NBD], and 4 vascular BD [VBD]) at weeks 0, 2, and 6 and every 8 weeks thereafter until week 46. In patients who showed inadequate responses to IFX after week 30, the dose was increased to 10 mg/kg. We then calculated the percentage of complete responders according to the predefined criteria depending on the symptoms and results of examinations (ileocolonoscopy, brain magnetic resonance imaging, computed tomography angiography, positron emission tomography, cerebrospinal fluid, or serum inflammatory markers), exploring the percentage of complete responders at week 30 (primary endpoint). The percentage of complete responders was 61% (11/18) at both weeks 14 and 30 and remained the same until week 54. Intestinal BD patients showed improvement in clinical symptoms along with decrease in C-reactive protein (CRP) levels after week 2. Consistently, scarring or healing of the principal ulcers was found in more than 80% of these patients after week 14. NBD patients showed improvement in clinical symptoms, imaging findings, and cerebrospinal fluid examinations. VBD patients showed improvement in clinical symptoms after week 2 with reductions in CRP levels and erythrocyte sedimentation rate. Imaging findings showed reversal of inflammatory changes in 3 of the 4 VBD patients. Irrespective of the type of BD, all patients achieved improvement in quality of life, leading to the dose reduction or withdrawal of steroids. IFX dose was increased to 10 mg/kg in 3

  12. 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

  13. 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…

  14. 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...

  15. 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…

  16. 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…

  17. 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…

  18. 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…

  19. 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.

  20. Pharmacokinetic evaluation of a 1,3-dicyclohexylurea nanosuspension formulation to support early efficacy assessment

    NASA Astrophysics Data System (ADS)

    Wahlstrom, Jan L.; Chiang, Po-Chang; Ghosh, Sarbani; Warren, Chad J.; Wene, Steve P.; Albin, Lesley A.; Smith, Mark E.; Roberds, Steven L.

    2007-06-01

    Time and resource constraints necessitate increasingly early decisions to advance or halt pre-clinical drug discovery programs. Early discovery or “tool” compounds may be potent inhibitors of new targets, but all too often they exhibit poor pharmaceutical and pharmacokinetic properties that make early assessment of in vivo efficacy difficult. 1,3-Dicyclohexylurea, a potent and selective inhibitor of soluble epoxide hydrolase (sEH), reduces blood pressure in hypertensive preclinical animal models when administered intraperitoneally using DMSO/corn oil as a delivery vehicle. However, the poor aqueous solubility of DCU poses a challenge for in vivo dosing in a multiple dose situation. Therefore, we developed a nanosuspension formulation of DCU to support oral, intravenous bolus and intravenous infusion dosing. Use of the nanosuspension formulation maintained DCU free plasma levels above the sEH IC50 and demonstrated that the application of formulation technology can accelerate in vivo evaluation of new targets by enabling pharmacodynamic studies of poorly soluble compounds.

  1. Performance evaluation of biofil toilet waste digester technologies in Ghana: the efficacy of effluent treatment options.

    PubMed

    Amoah, Philip; Gbenatey Nartey, Eric; Schrecongost, Alyse

    2016-12-01

    The study was carried out to assess the efficacy of a standard Biofil toilet digester with regard to its effluent quality and to evaluate the performance of new effluent polishing options being developed by BiofilCom. Influent and effluent were collected from 18 standard Biofil digesters connected to full-flush toilets. Effluent from five pilot installations with improved effluent polishing options were also taken for analyses. Ten other Biofil installations were selected to assess the impact of digester effluent discharge on the surrounding soil. Pollutant concentrations in the Biofil effluent exceeded both Ghana EPA and WHO standards for discharge though pollutant removal efficiencies were high: 84% for biochemical oxygen demand, 86.1% for chemical oxygen demand and 82.4% for total suspended solids. Escherichia coli and total coliform levels were significantly reduced by 63% and 95.6%, respectively, and nutrients were the least removed from effluents. Generally, effluents from the majority of the pilot polishing options met most of the discharge standards. E. coli were present in the soil at all study sites, except one. Biofil digester effluent is discharged subsurface but comparing their effluent quality with standards for discharge into water courses is relevant especially in areas of frequent flooding and high water tables.

  2. 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

  3. Biomimetic urothelial tissue models for the in vitro evaluation of barrier physiology and bladder drug efficacy.

    PubMed

    Baker, Simon C; Shabir, Saqib; Southgate, Jennifer

    2014-07-01

    The bladder is an important tissue in which to evaluate xenobiotic drug interactions and toxicities due to the concentration of parent drug and hepatic/enteric-derived metabolites in the urine as a result of renal excretion. Breaching of the barrier provided by the bladder epithelial lining (the urothelium) can expose the underlying tissues to urine and cause harmful effects (e.g., cystitis or cancer). Human urothelium is most commonly represented in vitro as immortalized or established cancer-derived cell lines, but the compromised ability of such cells to undergo differentiation and barrier formation means that nonimmortalized, normal human urothelial (NHU) cells provide a more relevant cell culture system. The impressive capacity for urothelial self-renewal in vivo can be harnessed in vitro to generate experimentally-useful quantities of NHU cells, which can subsequently be differentiated to form a functional or "biomimetic" urothelium. When seeded onto permeable membranes, these barrier-forming human urothelial tissue models enable the modeling of serum and luminal (intravesical) exposure to drugs and metabolites, thus supporting efficacy/toxicity assessments. Biomimetic human urothelial constructs provide a potential step along the preclinical trail and may support the extrapolation from rodent in vivo data to determine human relevance. Early evidence is beginning to demonstrate that human urothelium in vitro can provide information that supersedes conventional rodent studies, but further validation is needed to support widespread adoption.

  4. 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

  5. Pilot-scale evaluation of UV reactors' efficacy against in vitro infectivity of Cryptosporidium parvum oocysts.

    PubMed

    Entrala, Emilio; Garin, Yves J F; Meneceur, Pascale; Hayat, Maud; Scherpereel, Guillaume; Savin, Cyril; Féliers, Cédric; Derouin, Francis

    2007-12-01

    An experimental protocol was developed to assess the efficacy of two UV reactors (medium-pressure UVaster), and a low-pressure reactor) on the infectivity of Cryptosporidium parvum oocysts under conditions mimicking small- or medium-size water distribution units. The protocol included purification of large amounts of viable oocysts from experimentally infected calf feces, pilot spiking, sample concentration and purification after UV radiation, oocyst quantification and in vitro evaluation of oocyst infectivity on HCT-8 cells. Water samples were collected at intervals upstream and downstream from the UV reactor after spiking. Oocysts were concentrated by centrifugation, purified by immunomagnetic capture and quantified using laser-scanning cytometry. An enhanced in vitro infectivity test on HCT-8 cells was developed, where oocysts were pretreated in order to obtain maximized in vitro infectivity, and infectious foci were enumerated after immunofluorescence staining after 3 days of culture. This method was superior to viability measured by excystation for assessing oocyst infectivity. The infectivity rate of untreated oocysts ranged between 9% and 30% in replicate experiments. The method allowed us to determine inactivation rates >4.92 (log) with UVaster and >4.82 with the LP reactor after exposition of oocysts to an effective dose of 400 J m(-2) at flow rates of 15 and 42 m(3) h(-1), respectively.

  6. 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

  7. Evaluation of the Efficacy and Safety of Rivaroxaban Using a Computer Model for Blood Coagulation

    PubMed Central

    Burghaus, Rolf; Coboeken, Katrin; Gaub, Thomas; Kuepfer, Lars; Sensse, Anke; Siegmund, Hans-Ulrich; Weiss, Wolfgang; Mueck, Wolfgang; Lippert, Joerg

    2011-01-01

    Rivaroxaban is an oral, direct Factor Xa inhibitor approved in the European Union and several other countries for the prevention of venous thromboembolism in adult patients undergoing elective hip or knee replacement surgery and is in advanced clinical development for the treatment of thromboembolic disorders. Its mechanism of action is antithrombin independent and differs from that of other anticoagulants, such as warfarin (a vitamin K antagonist), enoxaparin (an indirect thrombin/Factor Xa inhibitor) and dabigatran (a direct thrombin inhibitor). A blood coagulation computer model has been developed, based on several published models and preclinical and clinical data. Unlike previous models, the current model takes into account both the intrinsic and extrinsic pathways of the coagulation cascade, and possesses some unique features, including a blood flow component and a portfolio of drug action mechanisms. This study aimed to use the model to compare the mechanism of action of rivaroxaban with that of warfarin, and to evaluate the efficacy and safety of different rivaroxaban doses with other anticoagulants included in the model. Rather than reproducing known standard clinical measurements, such as the prothrombin time and activated partial thromboplastin time clotting tests, the anticoagulant benchmarking was based on a simulation of physiologically plausible clotting scenarios. Compared with warfarin, rivaroxaban showed a favourable sensitivity for tissue factor concentration inducing clotting, and a steep concentration–effect relationship, rapidly flattening towards higher inhibitor concentrations, both suggesting a broad therapeutic window. The predicted dosing window is highly accordant with the final dose recommendation based upon extensive clinical studies. PMID:21526168

  8. Efficacy of a hypotonic treatment for peritoneal dissemination from gastric cancer cells: an in vivo evaluation.

    PubMed

    Shiozaki, Atsushi; Ichikawa, Daisuke; Takemoto, Kenichi; Nako, Yoshito; Nakashima, Shingo; Shimizu, Hiroki; Kitagawa, Maki; Kosuga, Toshiyuki; Konishi, Hirotaka; Komatsu, Shuhei; Fujiwara, Hitoshi; Okamoto, Kazuma; Marunaka, Yoshinori; Otsuji, Eigo

    2014-01-01

    The aim of the present study was to determine the efficacy of a hypotonic treatment for peritoneal dissemination from gastric cancer cells using an in vivo model. We firstly evaluated the toxicity of a peritoneal injection of distilled water (DW) (2 mL for 3 days) in mice. Macroscopic and microscopic examinations revealed that the peritoneal injection of DW did not severely damage the abdominal organs of these mice. MKN45 gastric cancer cells preincubated with NaCl buffer or DW for 20 minutes in vitro were then intraperitoneally injected into nude mice, and the development of dissemination nodules was analyzed. The total number, weight, and volume of the dissemination nodules were significantly decreased by the DW preincubation. We then determined whether the peritoneal injection of DW inhibited the establishment of peritoneal dissemination. After a peritoneal injection of MKN45 cells into nude mice, NaCl buffer or DW was injected into the abdominal cavity for 3 days. The total volume of dissemination nodules was significantly lower in DW-injected mice than in NaCl-injected mice. In conclusion, we demonstrated the safeness of a peritoneal injection of DW. Furthermore, the development of dissemination nodules from gastric cancer cells was prevented by a preincubation with or peritoneal injection of DW. PMID:25093178

  9. 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

  10. 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

  11. Evaluation of oral tilmicosin efficacy against severe cryptosporidiosis in neonatal kids under field conditions.

    PubMed

    Paraud, C; Pors, I; Chartier, C

    2010-05-28

    Many compounds have been screened for their potential anti-cryptosporidial activity in ruminants but none of them has been totally efficient in controlling the disease. Macrolide antibiotics have demonstrated some activity against Cryptosporidium spp. in humans. Tilmicosin is a macrolide antibiotic, available in France in an oral form (Pulmotil AC, Lilly France). The preventive efficacy of tilmicosin was evaluated in a goat farm experiencing severe clinical cryptosporidiosis in kids. Twenty-two kids were separated from their dams just after birth and placed in a separated pen. They were divided into 3 groups: an untreated group (10 kids), group 1 (6 kids) receiving tilmicosin at 25mg/kg BW/day and group 2 (6 kids) receiving tilmicosin at 50mg/kg BW/day. Tilmicosin was individually given by oral route from day 2 of age for 10 days. Three times a week, individual faecal samples were performed to assess the oocyst output. Clinical data, i.e. diarrhea and mortality, were recorded. In control kids, the highest prevalence and intensity of excretion were observed between day 6 and day 16 of age and mortality reached 90%. Excretion dynamic and clinical consequences were similar in both treated kid groups. Finally, tilmicosin did not demonstrate any activity against severe kid cryptosporidiosis in field conditions.

  12. 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

  13. Evaluation of the efficacy and safety of rivaroxaban using a computer model for blood coagulation.

    PubMed

    Burghaus, Rolf; Coboeken, Katrin; Gaub, Thomas; Kuepfer, Lars; Sensse, Anke; Siegmund, Hans-Ulrich; Weiss, Wolfgang; Mueck, Wolfgang; Lippert, Joerg

    2011-01-01

    Rivaroxaban is an oral, direct Factor Xa inhibitor approved in the European Union and several other countries for the prevention of venous thromboembolism in adult patients undergoing elective hip or knee replacement surgery and is in advanced clinical development for the treatment of thromboembolic disorders. Its mechanism of action is antithrombin independent and differs from that of other anticoagulants, such as warfarin (a vitamin K antagonist), enoxaparin (an indirect thrombin/Factor Xa inhibitor) and dabigatran (a direct thrombin inhibitor). A blood coagulation computer model has been developed, based on several published models and preclinical and clinical data. Unlike previous models, the current model takes into account both the intrinsic and extrinsic pathways of the coagulation cascade, and possesses some unique features, including a blood flow component and a portfolio of drug action mechanisms. This study aimed to use the model to compare the mechanism of action of rivaroxaban with that of warfarin, and to evaluate the efficacy and safety of different rivaroxaban doses with other anticoagulants included in the model. Rather than reproducing known standard clinical measurements, such as the prothrombin time and activated partial thromboplastin time clotting tests, the anticoagulant benchmarking was based on a simulation of physiologically plausible clotting scenarios. Compared with warfarin, rivaroxaban showed a favourable sensitivity for tissue factor concentration inducing clotting, and a steep concentration-effect relationship, rapidly flattening towards higher inhibitor concentrations, both suggesting a broad therapeutic window. The predicted dosing window is highly accordant with the final dose recommendation based upon extensive clinical studies. PMID:21526168

  14. 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

  15. 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.

  16. 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

  17. Characterization of a Cynomolgus Macaque Model of Pneumonic Plague for Evaluation of Vaccine Efficacy.

    PubMed

    Fellows, Patricia; Price, Jessica; Martin, Shannon; Metcalfe, Karen; Krile, Robert; Barnewall, Roy; Hart, Mary Kate; Lockman, Hank

    2015-09-01

    The efficacy of a recombinant plague vaccine (rF1V) was evaluated in cynomolgus macaques (CMs) to establish the relationship among vaccine doses, antibody titers, and survival following an aerosol challenge with a lethal dose of Yersinia pestis strain Colorado 92. CMs were vaccinated with a range of rF1V doses on a three-dose schedule (days 0, 56, and 121) to provide a range of survival outcomes. The humoral immune response following vaccination was evaluated with anti-rF1, anti-rV, and anti-rF1V bridge enzyme-linked immunosorbent assays (ELISAs). Animals were challenged via aerosol exposure on day 149. Vaccine doses and antibody responses were each significantly associated with the probability of CM survival (P < 0.0001). Vaccination also decreased signs of pneumonic plague in a dose-dependent manner. There were statistically significant correlations between the vaccine dose and the time to onset of fever (P < 0.0001), the time from onset of fever to death (P < 0.0001), the time to onset of elevated respiratory rate (P = 0.0003), and the time to onset of decreased activity (P = 0.0251) postinfection in animals exhibiting these clinical signs. Delays in the onset of these clinical signs of disease were associated with larger doses of rF1V. Immunization with ≥ 12 μg of rF1V resulted in 100% CM survival. Since both the vaccine dose and anti-rF1V antibody titers correlate with survival, rF1V bridge ELISA titers can be used as a correlate of protection.

  18. Efficacy of botulinum toxin type B for the treatment of primary palmar hyperhidrosis: a prospective, open, single-blind, multi-centre study.

    PubMed

    Basciani, Mario; Di Rienzo, Filomena; Bizzarrini, Massimo; Zanchi, Malvina; Copetti, Massimiliano; Intiso, Domenico

    2014-07-01

    Primary palmar hyperhidrosis is a distressing and disabling condition that can produce social, psychological and occupational problems. Although the use of botulinum toxin type A (BoNT-A) has been reported as an efficacious and safe intervention to improve palmar hyperhidrosis, only one study concerned botulinum toxin type B (BoNT-B) in this disorder. The aim of study was to evaluate the efficacy and safety of BoNT-B in treating primary palmar hyperhidrosis. Participants were injected with 5,000 IU of BoNT-B in each palm. Visual analogue test (VAS) to evaluate the intensity of decrease in sweat production, Minor's iodine starch test and measurement of paper towels' weight were used to ascertain palmar sweating at baseline, 4, 12 and 24 weeks after BoNT-B injections by a blind examiner. Thirty-two subjects (12 males, 20 females, mean age 31 ± 11) were enrolled. Significant reduction of palmar sweating was detected after BoNT-B injection: 2.9 ± 1.4, 0.3 ± 0.4, 0.9 ± 0.8, and 2.1 ± 1.5 g (p < 0.001) of paper towels' weight for the right palm at baseline, 4, 12 and 24 weeks; and 2.8 ± 1.7, 0.5 ± 0.6, 0.8 ± 0.7, and 1.8 ± 1.25 g (p < 0.001) at same time, respectively for the left palm. Significant reduction of mean VAS values were also detected after BoNT-B injections: 8.6 ± 1.1, 0.6 ± 0.8, 3.5 ± 2.5, and 7.1 ± 2.4 (p < 0.0001) at baseline, 4, 12 and 24 weeks, respectively. Mild side effects consisting in local pain and hand weakness were observed in 4 (12.5%) subjects. The findings indicated that the use of 5,000 IU BoNT-B injection in each palm was safe and significantly improved the severity of palmar hyperhidrosis. PMID:24522897

  19. Efficacy of botulinum toxin type B for the treatment of primary palmar hyperhidrosis: a prospective, open, single-blind, multi-centre study.

    PubMed

    Basciani, Mario; Di Rienzo, Filomena; Bizzarrini, Massimo; Zanchi, Malvina; Copetti, Massimiliano; Intiso, Domenico

    2014-07-01

    Primary palmar hyperhidrosis is a distressing and disabling condition that can produce social, psychological and occupational problems. Although the use of botulinum toxin type A (BoNT-A) has been reported as an efficacious and safe intervention to improve palmar hyperhidrosis, only one study concerned botulinum toxin type B (BoNT-B) in this disorder. The aim of study was to evaluate the efficacy and safety of BoNT-B in treating primary palmar hyperhidrosis. Participants were injected with 5,000 IU of BoNT-B in each palm. Visual analogue test (VAS) to evaluate the intensity of decrease in sweat production, Minor's iodine starch test and measurement of paper towels' weight were used to ascertain palmar sweating at baseline, 4, 12 and 24 weeks after BoNT-B injections by a blind examiner. Thirty-two subjects (12 males, 20 females, mean age 31 ± 11) were enrolled. Significant reduction of palmar sweating was detected after BoNT-B injection: 2.9 ± 1.4, 0.3 ± 0.4, 0.9 ± 0.8, and 2.1 ± 1.5 g (p < 0.001) of paper towels' weight for the right palm at baseline, 4, 12 and 24 weeks; and 2.8 ± 1.7, 0.5 ± 0.6, 0.8 ± 0.7, and 1.8 ± 1.25 g (p < 0.001) at same time, respectively for the left palm. Significant reduction of mean VAS values were also detected after BoNT-B injections: 8.6 ± 1.1, 0.6 ± 0.8, 3.5 ± 2.5, and 7.1 ± 2.4 (p < 0.0001) at baseline, 4, 12 and 24 weeks, respectively. Mild side effects consisting in local pain and hand weakness were observed in 4 (12.5%) subjects. The findings indicated that the use of 5,000 IU BoNT-B injection in each palm was safe and significantly improved the severity of palmar hyperhidrosis.

  20. Evaluation of the functional efficacy of an antioxidative probiotic in healthy volunteers

    PubMed Central

    Songisepp, Epp; Kals, Jaak; Kullisaar, Tiiu; Mändar, Reet; Hütt, Pirje; Zilmer, Mihkel; Mikelsaar, Marika

    2005-01-01

    Background In persons without clinical symptom it is difficult to assess an impact of probiotics regarding its effect on health. We evaluated the functional efficacy of the probiotic Lactobacillus fermentum ME-3 in healthy volunteers by measuring the influence of two different formulations on intestinal lactoflora, fecal recovery of the probiotic strain and oxidative stress markers of blood and urine after 3 weeks consumption. Methods Two 3-week healthy volunteer trials were performed. Open placebo controlled (OPC) study participants (n = 21) consumed either goat milk or by L. fermentum ME-3 fermented goat milk (daily dose 11.8 log CFU (Colony Forming Units). Double blind randomised placebo controlled (DBRP) study participants (n = 24) received either capsules with L. fermentum ME-3 (daily of dose 9.2 CFU) or placebo capsules. The faecal lactoflora composition, faecal ME-3 recovery, effect of the consumption on intestinal lactoflora, and oxidative stress markers of blood (total antioxidative activity; total antioxidative status and glutathione red-ox ratio) was measured. Results ME-3 was well tolerated and a significant increase in total faecal lactobacilli yet no predominance of ME-3 was detected in all study groups. Faecal recovery of ME-3 was documented by molecular methods only in fermented milk group, however the significant improvement of blood TAA (Total Antioxidative Activity) and TAS (Total Antioxidative Status) indices was seen both in case of fermented goat milk and capsules", yet glutathione re-ox ratio values decreased only in case of fermented by ME-3 goat milk. Conclusion The functional efficacy of both consumed formulations of an antioxidative probiotic L. fermentum ME-3 is proved by the increase of the intestinal lactobacilli counts providing putative defence against enteric infections and by reduction of the oxidative stress indices of blood and urine of healthy volunteers. In non-diseased host the probiotic health claims can be assessed by

  1. [Efficacy of probiotic feed additives: guidelines for the evaluation of the efficiency of microorganisms in dogs, cats, and horses].

    PubMed

    Lahrssen, M; Zentek, J

    2002-01-01

    Probiotic microorganisms are frequently in use as feed additives for farm and pet animals. For admission for the common market products have to be tested according to the feed additive directive 70/524/EC. The dossier for admission has to comprise data of efficiency as laid down in the directive 87/153/EC. During the last years it became obvious after the evaluation of several dossiers, that no definitive criteria for the assessment of efficacy were available for dogs, cats and horses (84/153/EC). Aspects like the promotion of animal production are not relevant in this context. Therefore, the European commission launched the directive for the evaluation of efficacy of microorganisms for dogs, cats and horses, that supports the evaluation of microbial feed additives and which is described in this paper. PMID:11838292

  2. 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

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

    PubMed Central

    Long, L.; Hager, C.

    2016-01-01

    The treatment of dermatophytoses, including onychomycosis, has come a long way over the past few decades with the introduction of oral antifungals (e.g., terbinafine and itraconazole). However, with these advancements in oral therapies come several undesirable effects, such as kidney and liver toxicity, along with drug-drug interactions. Consequently, there is a need for new topical agents that are effective against dermatophytosis. ME1111 is a topical antifungal under development. In this study, the in vivo efficacy of ME1111 was compared to that of ciclopirox in the topical treatment of dermatophytosis caused by Trichophyton mentagrophytes using a guinea pig model. Animals were treated with the topical antifungals starting at 3 days postinfection, with each agent being applied once daily for seven consecutive days. After the treatment period, the clinical and mycological efficacies were evaluated. The data showed that both antifungals demonstrated significant clinical and mycological efficacies; however, ME1111 showed clinical efficacy superior to that of ciclopirox (46.9% and 25.0%, respectively, with a P value of <0.001). The potent efficacy of ME1111 could be attributed to its properties, such as low keratin binding. PMID:26833160

  4. A Network Pharmacology Approach to Evaluating the Efficacy of Chinese Medicine Using Genome-Wide Transcriptional Expression Data

    PubMed Central

    Wu, Leihong; Wang, Yi; Nie, Jing; Cheng, Yiyu

    2013-01-01

    The research of multicomponent drugs, such as in Chinese Medicine, on both mechanism dissection and drug discovery is challenging, especially the approaches to systematically evaluating the efficacy at a molecular level. Here, we presented a network pharmacology-based approach to evaluating the efficacy of multicomponent drugs by genome-wide transcriptional expression data and applied it to Shenmai injection (SHENMAI), a widely used Chinese Medicine composed of red ginseng (RG) and Radix Ophiopogonis (RO) in clinically treating myocardial ischemia (MI) diseases. The disease network, MI network in this case, was constructed by combining the protein-protein interactions (PPI) involved in the MI enriched pathways. The therapeutic efficacy of SHENMAI, RG, and RO was therefore evaluated by a network parameter, namely, network recovery index (NRI), which quantitatively evaluates the overall recovery rate in MI network. The NRI of SHENMAI, RG, and RO were 0.876, 0.494, and 0.269 respectively, which indicated SHENMAI exerts protective effects and the synergistic effect of RG and RO on treating myocardial ischemia disease. The successful application of SHENMAI implied that the proposed network pharmacology-based approach could help researchers to better evaluate a multicomponent drug on a systematic and molecular level. PMID:23737854

  5. 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

  6. 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

  7. Laboratory evaluations of elmex inter X toothbrushes for interproximal access efficacy and posterior tooth surface cleaning.

    PubMed

    Yankell, S L; Shi, X; Emling, R C

    2002-01-01

    Laboratory methods have been developed to evaluate the ability of toothbrush bristles to remove artificial plaque deposits at interproximal sites (Interproximal Access Efficacy; IAE) and on distal tooth surfaces (Posterior Tooth Surface Cleaning; PTSC). In the testing performed for this study, six toothbrushes were evaluated. These were: elmex inter X Sensitive; elmex inter X Sensitive Short Head; elmex inter X medium; elmex inter X Medium Short Head; Oral-B Cross Action 40 medium; and the ADA reference standard toothbrush. Six toothbrushes of each design were tested four times under wet brushing conditions in all assays. In the IAE studies, toothbrushing was conducted using a vertical or horizontal brushing motion, simulated anterior or posterior teeth, and a brushing weight of 250 g. The bristles were placed at a 90 degree angle to the tooth surface, and brushing was performed for 15 seconds at two strokes per second with 50 mm strokes. IAE was recorded as the maximum width of simulated plaque deposit removed. For the PTSC evaluations, a horizontal brushing motion was used on posterior tooth shapes, with a 250 g brushing pressure for ten seconds. PTSC was determined as the maximum measurement of artificial plaque deposit removed from the mid-facial area to the maximum post-distal area of the most posterior simulated tooth shape. All data were assessed with ANOVA and the post hoc Tukey test. In the individual IAE tests, with vertical or horizontal brushing on anterior and posterior simulated teeth, and on overall IAE mean values, the four elmex inter X toothbrushes were significantly higher (p < 0.01-0.001) than the ADA reference standard and the Oral-B Cross Action 40 toothbrushes. The mean PTSC values for all toothbrushes were significantly higher (p < 0.01-0.001) compared to the ADA Reference Standard toothbrush mean PTSC. All elmex inter X brushes were statistically significantly higher (p < 0.01-0.001) compared to the Oral-B Cross Action 40 product. The elmex

  8. 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

  9. 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

  10. 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

  11. 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

  12. Evaluation of efficacy and tolerability of glimepiride and metformin combination: a multicentric study in patients with type-2 diabetes mellitus, uncontrolled on monotherapy with sulfonylurea or metformin.

    PubMed

    Pareek, Anil; Chandurkar, Nitin B; Salkar, Harsha R; Borkar, Mangala S; Tiwari, Dharmendra

    2013-01-01

    The objectives of this study were to evaluate the efficacy and tolerability of glimepiride plus extended release metformin (MET) on glycemic control in patients with type-2 diabetes mellitus uncontrolled on monotherapy with sulfonylurea or MET. This was a prospective, open-labeled, multicentric study over 12 weeks. Patients who were diagnosed with type-2 diabetes and were uncontrolled on monotherapy with single oral hypoglycemic agents such as glimepiride or MET and characterized by glycosylated hemoglobin (HbA1c) ≥7% and ≤10% and fasting plasma glucose (FPG) ≥ 140 mg/dL were enrolled in this study. Treatment regimen was started at 1 mg of glimepiride plus 500 mg of MET once a day and was titrated to next dose level depending on the clinician's judgment, not exceeding a total daily dose of 8 mg of glimepiride and 2000 mg of MET. After 12-weektreatment, glimepiride plus MET combination showed improvement in metabolic control as assessed by changes in HbA1c, FPG, and post prandial glucose (PPG). Primary efficacy parameter, HbA1c, was significantly reduced to (7.65 ± 1.70) at the end of the treatment from the baseline value (8.35 ± 0.93) (P < 0.001). Of the patients, 65.79% showed ≥0.5% reduction in HbA1c and or HbA1c <7% at the end of the therapy. FPG and PPG were significantly reduced at the end of the therapy as compared with baseline values (P < 0.001). Moreover, the lipid profile was also improved during the treatment period. The addition of glimepiride to MET is an effective treatment for patients inadequately controlled on sulfonylurea or Met alone. A combination of glimepiride with MET achieves good glycemic control with better tolerability profile. PMID:21326082

  13. 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

  14. 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.

  15. Ethical problems with the mental health evaluation standards of care for adult gender variant prospective patients.

    PubMed

    Hale, C Jabob

    2007-01-01

    The World Professional Association for Transgender Health's "Standards of Care: The Hormonal and Surgical Sex Reassignment of Gender Dysphoric Persons" (SOC) set forth standards clinicians must meet to ensure ethical care of adequate quality. The SOC also set requirements gender variant prospective patients must meet to receive medical interventions to change their sexual characteristics to those more typical for the sex to which they were not assigned at birth. One such requirement is that mental health professionals must ascertain that prospective patients have met the SOC's eligibility and readiness criteria. This article raises two objections to this requirement: ethically obligatory considerations of the overall balance of potential harms and benefits tell against it, and it violates the principle of respect for autonomy. This requirement treats gender variant prospective patients who request medical intervention as different in kind, not merely degree, from other patient populations, as it constructs the very request as a phenomenon of incapacity. This is ethically indefensible in and of itself, but it is especially pernicious in a sociocultural and political context that already denies gender variant people full moral status. PMID:17951884

  16. [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

  17. Evaluation of the pharmacotherapeutic efficacy of Garcinia cambogia plus Amorphophallus konjac for the treatment of obesity.

    PubMed

    Vasques, Carlos A R; Rossetto, Simone; Halmenschlager, Graziele; Linden, Rafael; Heckler, Eliane; Fernandez, Maria S Poblador; Alonso, José L Lancho

    2008-09-01

    Hydroxycitric acid (HCA), the main compound of Garcinia cambogia extract, is a competitive blocker of ATP-citrate-lyase, presenting a potential inhibition of fatty acid biosynthesis. Glucomannan fibers, abundant in Amorphophallus konjac, seem to reduce the absorption kinetics of dietary fat. Therefore, the aim of this double-blind randomized study was to evaluate the pharmacotherapeutic efficacy of standardized extracts of G. cambogia (52.4% HCA) plus A. konjac (94.9% glucomannan) in the treatment of obesity. Fifty-eight obese subjects (BMI 30.0-39.9 kg/m(2)) were assigned to the placebo group (n = 26) or the treatment group (n = 32); no dietary restrictions were applied. Over a 12-week period, subjects were given daily doses of either Garcinia (2.4 g) plus Konjac (1.5 g) or placebo prior to their main meals (3 times/day). Before the start of treatment, and every 4 weeks thereafter, the following were recorded: height, weight, circumferences and body composition, resting energy expenditure (REE), lipid profile and glucose levels. The treatment had no significant effect on anthropometric parameters, REE, triglycerides or glucose levels. However, a significant reduction was observed in total cholesterol (-32.0 +/- 35.1 mg/dL) and LDL-c levels (-28.7 +/- 32.7 mg/dL) in the treated group, the final levels being significantly lower than those of the placebo group (p = 0.008 and p = 0.020, respectively). The results obtained suggest that the treatment had a significant hypocholesterolemic effect, without influencing the anthropometric or calorimetric parameters tested. PMID:18729243

  18. 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

  19. [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.

  20. 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

  1. 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

  2. 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

  3. 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

  4. Pilot evaluation of the efficacy of shampoo treatment with ultrapure soft water for canine pruritus.

    PubMed

    Ohmori, Keitaro; Tanaka, Akane; Makita, Yuka; Takai, Masaki; Yoshinari, Yuji; Matsuda, Hiroshi

    2010-10-01

    Ultrapure soft water (UPSW) is water in which calcium and magnesium ions have been replaced with sodium ions using a cation-exchange resin. We recently demonstrated that washing with soap and UPSW reduced the clinical severity of dermatitis and improved the skin barrier function in NC/NgaTnd mice, a murine model for human atopic dermatitis. The purpose of this pilot study was to evaluate the efficacy of shampoo treatment with UPSW for dogs with pruritus. Eleven dogs with pruritus were randomly assigned to two groups depending on whether they received weekly shampoo treatment with UPSW or tap water for 4 weeks. After a washout period, the treatment protocol was switched such that each dog received both treatments. The pre-treatment and post-treatment values of the following were compared: pruritus scores assessed by the owners; dermatitis scores recorded by an investigator; and transepidermal water loss (TEWL). Shampoo treatment with UPSW significantly decreased pruritus and dermatitis scores in the dogs, whereas shampoo treatment with tap water did not. In addition, shampoo treatment with UPSW, but not with tap water, significantly reduced TEWL in the dogs. Adverse events due to the treatment were not observed in the dogs. Furthermore, we found that topical application of UPSW for barrier-disrupted skin caused by tape stripping in healthy dogs decreased TEWL more rapidly than topical application of tap water. Our findings suggest that shampoo treatment with UPSW promotes skin barrier recovery and thus could be considered as a possible therapeutic option in the management of pruritus and dermatitis in dogs.

  5. Efficacy of inpatient treatment for atopic dermatitis evaluated by changes in serum cortisol levels.

    PubMed

    Fukuda, Hidetsugu; Suzuki, Taku; Saotome, Atsuko; Sode, Eri; Mukai, Hideki

    2013-01-01

    When dealing with patients with severe atopic dermatitis (AD), inpatient treatment is useful for alleviating skin symptoms in short periods of time. We previously found that many severe AD patients had low serum cortisol levels at admission. The present study was undertaken to evaluate the efficacy of inpatient treatment in 29 adults with AD through comparisons of serum cortisol, plasma adrenocorticotropic hormone (ACTH), serum thymus and activation-regulated chemokine (TARC), and serum lactate dehydrogenase (LDH) levels at admission with those at the time of discharge. Serum cortisol and plasma ACTH levels were significantly higher at discharge. On the other hand, serum TARC and serum LDH were significantly lower at discharge. We examined whether the suppression of hypothalamic-pituitary-adrenocortical function that was seen at admission was attributable to disturbed circadian rhythms due to sleep disorders by analyzing hypothalamic-pituitary-adrenocortical function in relation to the presence/absence of sleep disorders, serum cortisol levels and daily urinary free cortisol. Of the 17 patients with low serum cortisol levels upon admission, 15 (88.2%) had sleep disorders upon admission. However, the daily urinary free cortisol increased significantly from 8.0 ± 5.5 μg/day (at admission) to 18.5 ± 17.2 μg/day (at discharge). These results suggested that the suppression of endocrine function seen at admission was not attributable to disturbed circadian rhythms due to sleep disorders but represented true suppression of the endocrine system. These results indicated that inpatient care was useful for treating patients with severe AD, enabling efficient improvement of the skin condition and recovery from suppressed endocrine function.

  6. Evaluating efficacy of various operative procedures done in anterior urethral stricture using urethral stricture score

    PubMed Central

    Mathur, Rajkumar; Patil, Lukesh A.; Khan, Fareed

    2016-01-01

    Context: Scoring systems have been an important tool of clinical decision making in medicine. As scoring systems like Glasgow Coma scale have made a revolutionary change in stratifying the patient, in particular, clinical scenario. Wiegand et al. in 2012 proposed UREThRAL Score a novel method to quantify anterior urethral stricture. Aims: The aim was to validate urethral stricture score (USS) for evaluating the efficacy of operative procedures. Settings and Design: Study was done in a retrospective manner and includes patients operated for anterior urethral stricture by a single surgeon in tertiary care center over the period of 2008–2014. Subjects and Methods: A total of 57 cases were included in this study who met the inclusion criteria, of these cases 7 underwent excision and primary anastomosis (EPA), 20 underwent preputial flap urethroplasty (PFUP), 22 underwent tunica albuginea urethroplasty (TAU), and rest 8 underwent scrotal flap urethroplasty (SFUP). Procedures were assigned different complexity level, and USS was compared with the particular procedure to see the relation between both. Statistical Analysis Used: Data were analyzed using ANOVA on SPSS software. Results: Mean USS for EPA, PFUP, TAU, and SFUP in our study group was found to be 6.57, 8.95, 9.00, and 10.00, respectively, with an overall USS of 9.03, with a standard deviation of 1.56. USS was significantly associated with complexity. Conclusions: Mean USS increased with increase in surgical complexity indicating that higher USS correlates with more complex surgery. Strongest association between complexity and the individual parameter was found with location and length. PMID:26834400

  7. Psychometric evaluation of dietary self-efficacy and outcome expectation scales in female college freshmen.

    PubMed

    Kedem, Leia E; Evans, Ellen M; Chapman-Novakofski, Karen

    2014-11-01

    Lifestyle interventions commonly measure psychosocial beliefs as precursors to positive behavior change, but often overlook questionnaire validation. This can affect measurement accuracy if the survey has been developed for a different population, as differing behavioral influences may affect instrument validity. The present study aimed to explore psychometric properties of self-efficacy and outcome expectation scales-originally developed for younger children-in a population of female college freshmen (N = 268). Exploratory principal component analysis was used to investigate underlying data patterns and assess validity of previously published subscales. Composite scores for reliable subscales (Cronbach's α ≥ .70) were calculated to help characterize self-efficacy and outcome expectation beliefs in this population. The outcome expectation factor structure clearly comprised of positive (α = .81-.90) and negative outcomes (α = .63-.67). The self-efficacy factor structure included themes of motivation and effort (α = .75-.94), but items pertaining to hunger and availability cross-loaded often. Based on cross-loading patterns and low Cronbach's alpha values, respectively, self-efficacy items regarding barriers to healthy eating and negative outcome expectation items should be refined to improve reliability. Composite scores suggested that eating healthfully was associated with positive outcomes, but self-efficacy to do so was lower. Thus, dietary interventions for college students may be more successful by including skill-building activities to enhance self-efficacy and increase the likelihood of behavior change.

  8. 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

  9. 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

    Grossman, Robert G; 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

    2014-02-01

    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.

  10. 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

  11. Evaluation of the efficacy and safety of Salvia officinalis in controlling hot flashes in prostate cancer patients treated with androgen deprivation.

    PubMed

    Vandecasteele, Katrien; Ost, Piet; Oosterlinck, Willem; Fonteyne, Valérie; Neve, Wilfried De; Meerleer, Gert De

    2012-02-01

    The purpose of this pilot study was to evaluate the efficacy and safety of Salvia officinalis in controlling hot flashes in prostate cancer patients treated with androgen deprivation therapy (ADT). Ten patients experiencing hot flashes were included in a single-centre prospective pilot study. Treatment consisted of 150 mg of Salvia officinalis extract taken orally three times daily. A diary questionnaire scoring hot flashes, subjective side effects and quality of life (QOL) had to be completed. Clinical examination was performed at every visit and the concentration of ADT-linked hormones, haemoglobin and cholesterol was measured before, during and after ending treatment. Before the start of treatment, a 1 week baseline registration was performed. An analysis of variance with time of measurement as a within-subject factor was performed. When analysing the hot flashes score, one patient was excluded due to insufficient diary notes. The mean weekly score declined from 112 (SD = 71) at baseline to 59 (SD = 54) at the end of treatment (p = 0.002). Hot flashes diminished significantly from the first week up to and including week 3. This was maintained during treatment. There was no effect on QOL. There were no side effects. It is concluded that Salvia officinalis is efficient and safe in the treatment hot flashes, without improving QOL.

  12. 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

  13. 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

  14. Long term follow-up concerning safety and efficacy of novel adhesion prophylactic agent for laparoscopic myomectomy in the prospective randomized ADBEE study.

    PubMed

    Cezar, Cristina; Tchartchian, Garri; Korell, Matthias; Ziegler, Nicole; Senshu, Kazuhisa; De Wilde, Maya Sophie; Herrmann, Anja; Larbig, Angelika; De Wilde, Rudy Leon

    2016-08-01

    We conducted a prospective randomized single blind - subject study in the University Clinic of Gynecology of Pius-Hospital Oldenburg. The primary objective of the ADBEE study was to assess the safety and manageability of ADBLOCK when used as an adjunct to laparoscopic surgery for the primary of myomas in women wishing to improve pregnancy outcomes. The study population included 32 women aged between 18-45 years, in good general health condition, who have not completed their family planning and who are undergoing primary ('virgin') laparoscopic myomectomy with an aim to improve pregnancy outcomes. The patients were randomized in 2 groups, ADBLOCK arm with 21 patients and surgery only arm with 11 patients. The study was single blind - subject and the investigators were blinded to treatment group assignment until completion of uterine suturing and prior to removal of the endoscope. A vigorous follow-up of subjects was organized, focusing on its two critical characteristics: completeness and duration. Completeness represented the percentage of subjects who returned to every planed follow - up appointments. The patients were evaluated in a specific period of time, which defined the duration of follow-up. Safety of the ADBLOCK was estimated after analyzing and documentation of any adverse events occurred, clinical and physical examination of patients as well as evaluation of laboratory measures. There were 25 adverse events reported in ADBLOCK treatment group and 12 events in NO-ADBLOCK group over the 24-months treatment. All adverse events in both treatment arms were not anticipated, with all events in the ADBLOCK group being resolved. At 28 days, there was no significant difference in proportion of events between the two treatments (p = 0.440). Overall, the number of events reported was low and the severity of events was generally mild with an unlikely or no relationship to treatment. There were no unanticipated device related adverse events seen in both treatment

  15. The Community as Client: Improving the Prospects for Useful Evaluation Findings.

    ERIC Educational Resources Information Center

    Telfair, Joseph; Leviton, Laura C.

    1999-01-01

    Presents the perspectives on commissioning and using evaluations of community-based agency leaders through interviews with four such leaders. Discusses respondents' needs and experiences in commissioning and using evaluations and their ideas about ideal evaluation products. (Author/SLD)

  16. [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

  17. Clinical Evaluation of Eye Movements in Spinocerebellar Ataxias: A Prospective Multicenter Study

    PubMed Central

    Moscovich, M.; Okun, Michael S.; Favilla, Chris; Figueroa, Karla P.; Pulst, Stefan M.; Perlman, Susan; Wilmot, George; Gomez, Christopher; Schmahmann, Jeremy; Paulson, Henry; Shakkottai, Vikram; Ying, Sarah; Zesiewicz, Theresa; Kuo, S. H.; Mazzoni, P.; Bushara, Khalaf; Xia, Guangbin; Ashizawa, Tetsuo; Subramony, S. H.

    2015-01-01

    Background Ocular motor abnormalities reflect the varied neuropathology of spinocerebellar ataxias (SCAs) and may serve to clinically distinguish the different SCAs. We analyzed the various eye movement abnormalities detected prospectively at the baseline visit during a large multicenter natural history study of SCAs 1, 2, 3, and 6. Methods The data were prospectively collected from 12 centers in the United States in patients with SCAs 1, 2, 3, and 6, as part of the Clinical Research Consortium for Spinocerebellar Ataxias (NIH-CRC-SCA). Patient characteristics, ataxia rating scales, the Unified Huntington Disease Rating Scale functional examination, and clinical staging were used. Eye movement abnormalities including nystagmus, disorders of saccades and pursuit, and ophthalmoparesis were recorded, and factors influencing their occurrence were examined. Results A total of 301 patients participated in this study, including 52 patients with SCA 1, 64 with SCA 2, 117 with SCA 3, and 68 with SCA 6. Although no specific ocular motor abnormality was pathognomonic to any SCA, significant differences were noted in their occurrence among different disorders. SCA 6 was characterized by frequent occurrence of nystagmus and abnormal pursuit and rarity of slow saccades and ophthalmoparesis and SCA 2 by the frequent occurrence of slow saccades and infrequent nystagmus and dysmetric saccades. SCA 1 and SCA 3 subjects had a more even distribution of eye movement abnormalities. Conclusions Prospective data from a large cohort of patients with SCAs 1, 2, 3, and 6 provide statistical validation that the SCAs exhibit distinct eye movement abnormalities that are useful in identifying the genotypes. Many of the abnormalities correlate with greater disease severity measures. PMID:25259863

  18. Best methods for evaluating educational impact: a comparison of the efficacy of commonly used measures of library instruction

    PubMed Central

    Schilling, Katherine; Applegate, Rachel

    2012-01-01

    Objectives and Background: Libraries are increasingly called upon to demonstrate student learning outcomes and the tangible benefits of library educational programs. This study reviewed and compared the efficacy of traditionally used measures for assessing library instruction, examining the benefits and drawbacks of assessment measures and exploring the extent to which knowledge, attitudes, and behaviors actually paralleled demonstrated skill levels. Methods: An overview of recent literature on the evaluation of information literacy education addressed these questions: (1) What evaluation measures are commonly used for evaluating library instruction? (2) What are the pros and cons of popular evaluation measures? (3) What are the relationships between measures of skills versus measures of attitudes and behavior? Research outcomes were used to identify relationships between measures of attitudes, behaviors, and skills, which are typically gathered via attitudinal surveys, written skills tests, or graded exercises. Results and Conclusions: Results provide useful information about the efficacy of instructional evaluation methods, including showing significant disparities between attitudes, skills, and information usage behaviors. This information can be used by librarians to implement the most appropriate evaluation methods for measuring important variables that accurately demonstrate students' attitudes, behaviors, or skills. PMID:23133325

  19. Evaluation of Antimicrobial and Antifungal Efficacy of Inter Appointment Intracanal Medicaments against Enterococcus and Candida albicans: An In Vitro Study

    PubMed Central

    Gupta, Shubh Prabhat; Bhati, Manisha; Jhajharia, Kapil; Patel, Hardik; Paliwal, Ashutosh; Franklin, Sundeep

    2015-01-01

    Background: Microorganisms and their by-products in pulpal and periapical diseases are to be considered as the primary etiological agents of the pulpal necrosis and apical periodontitis. Enterococcus faecalis, which is the most common organism isolated from failed root canals, is a Gram-positive facultative anaerobe. Yeasts can be detected in 7-18% of infected root canals. Materials and Methods: Designed to evaluate the antimicrobial and antifungal efficacy of chlorhexidine gutta-percha (CHX-GP), and calcium hydroxide GP points against E. faecalis and Candida albicans. The test materials used are divided into 3 groups; Group A - Control, Regular GP, Group B – CHX-GP, Group C - Calcium hydroxide GP. Detail Method is explained in the article. Results: There was a significant difference in the inhibition of E. faecalis, in different materials at each time interval period (P < 0.05). Similarly, the inhibition of C. albicans in the different materials at each time period was found to be statistically significant (P < 0.05). Calcium hydroxide GP did not exhibit any antimicrobial effect on any of tested microorganisms for all the time periods. Conclusion: CHX-GP had the maximum effect on the test microorganisms, with the maximum efficacy on E. faecalis followed by C. albicans. Regular GP also had a significant efficacy on test microorganisms, with the maximum efficacy on E. faecalis followed by C. albicans. Calcium hydroxide GP did not have any effect on any test microorganisms during the entire test periods. PMID:26124609

  20. 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.

  1. 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.

  2. A prospective, multi-center clinical and radiographic outcomes evaluation of ChronOS strip for lumbar spine fusion.

    PubMed

    Kanter, Adam S; Gandhoke, Gurpreet S; Welch, William C; Arnold, Paul M; Cheng, Joseph S; Okonkwo, David O

    2016-03-01

    This prospective clinical study evaluated the use of a composite bone void filler (ChronOS Strip, DePuy Synthes, West Chester, PA, USA), combined with bone marrow aspirate plus local autologous bone, in a series of patients undergoing instrumented posterolateral spinal fusion with interbody support. Seventy-six patients were enrolled and treated per protocol at 13 clinical sites. At 24 months, 55/76 patients (72%) were evaluated, with 49/76 (65%) having sufficient data to determine the primary endpoint. The primary endpoint, posterolateral fusion success, was achieved in 48/54 (88.9%) patients at 12 months and in 45/49 (91.8%) patients at 24 months. At all follow-up time points, statistically significant improvements were observed when compared to baseline in back and leg pain and functional status as measured by visual analog scale, Oswestry Disability Index and 12-Item Short Form health surveys. This prospective multi-center series provides evidence that the composite bone void filler, when applied posterolaterally with instrumentation, bone marrow aspirate and/or local autologous bone and concomitant interbody support, can be used to achieve a successful posterolateral fusion, resulting in improvements in clinical outcomes in patients with degenerative disc disease.

  3. Methods for the evaluation of the protective efficacy of sunscreen products.

    PubMed

    Vergou, T; Patzelt, A; Schanzer, S; Meinke, M C; Weigmann, H-J; Thiede, G; Sterry, W; Lademann, J; Darvin, M E

    2013-01-01

    The objective of the present investigation was to examine the utilization of optical and spectroscopic methods for the noninvasive characterization of Anthelios XL Fluide Extreme (SPF 50+), an exemplary sunscreen, concerning its homogeneity of distribution on the skin, its spectroscopic properties and its overall protective efficacy. The homogeneity of the distribution of the sunscreen on the skin was investigated with a multiphoton tomography microscope. Additionally, the sum transmission spectrum was determined using tape stripping and spectroscopic measurements. The results revealed a very homogeneous distribution of the sunscreen on the skin surface and also in the deep furrows. The sum transmission spectrum reflects a high protective efficacy of the sunscreen in both the UVA and UVB ranges. The sunscreen Anthelios XL Fluide Extreme (SPF 50+) generates a comfortable feeling on the skin and can be easily distributed. The presented optical methods have been shown to be suitable to investigate the overall protective efficacy of sunscreen products objectively, noninvasively and quickly.

  4. Examining Values, Use, and Role in Evaluation: Prospects for a Broadened View

    ERIC Educational Resources Information Center

    Boulay, David A.; Han, Heeyoung

    2008-01-01

    This article reviews evaluation studies published in the HRD (human resource development) field. The authors further discuss general evaluation theories in terms of value, use, and evaluator role. The comparison of this literature suggests that evaluation in HRD has been limited by narrow perspectives. The authors attribute this narrow notion of…

  5. 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.

  6. 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

  7. 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.

  8. 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

  9. Evaluation of the efficacy of yeast extract in reducing intestinal Clostridium perfringens levels in broiler chickens.

    PubMed

    Thanissery, R; McReynolds, J L; Conner, D E; Macklin, K S; Curtis, P A; Fasina, Y O

    2010-11-01

    The etiological agent of necrotic enteritis is Clostridium perfringens. Traditionally, necrotic enteritis is controlled with in-feed antibiotics. However, increasing consumer demand for drug-free poultry has fostered the search for nonantibiotic alternatives. Yeast extract contain nucleotides that are immunomodulatory and also essential for cellular functions. An experiment was conducted to evaluate the efficacy of NuPro yeast extract (Alltech Inc., Nicholasville, KY) in reducing intestinal C. perfringens levels in broiler chickens. One hundred ninety-two 1-d-old male broiler chicks were obtained and randomly assigned to 6 treatments in a battery cage trial. Treatment 1 consisted of chicks fed a corn-soybean meal basal diet (BD) without added bacitracin methylene disalicylate or NuPro. Treatment 2 consisted of chicks fed BD into which bacitracin methylene disalicylate was added at 0.055 g/kg. Treatment 3 consisted of chicks fed BD supplemented with NuPro at a 2% level for the first 10 d of the experiment. Treatments 4 (PX), 5, and 6 (PN) consisted of chicks that were challenged with 3 mL of the C. perfringens inoculum (~10(7) cfu/mL) on d 14, 15, and 16 of the experiment and fed diets similar to treatments 1, 2, and 3, respectively. On d 1 and 7 postchallenge, intestinal C. perfringens levels, lesion scores, and alkaline phosphatase activity were assessed. On d 1 postchallenge, C. perfringens level in treatment 5 (2.09 log(10) cfu/g) was lower (P < 0.05) compared with the PX treatment (4.71 log(10) cfu/g) but similar to the PN treatment (2.98 log(10) cfu/g). A similar trend was observed on d 7 postchallenge. NuPro supplementation enhanced alkaline phosphatase activity (P < 0.05) in C. perfringens-challenged chicks and appeared to reduce intestinal lesion scores. Although dietary supplementation of NuPro in the PN treatment reduced C. perfringens levels by 1.73 and 0.68 log(10) cfu/g compared with the PX treatment on d 1 and 7 postchallenge, respectively, these

  10. Preparation of bupleurum nasal spray and evaluation on its safety and efficacy.

    PubMed

    Xie, Yueling; Lu, Wei; Cao, Shilei; Jiang, Xinguo; Yin, Ming; Tang, Wenlu

    2006-01-01

    Radix Bupleuri is widely used in traditional medicine for the treatment of fever, pain, and inflammation associated with influenza or the common cold. The essential oil extracted from the herb is generally claimed to play the major role in the efficacious treatment of fever. The purpose of the present study was to formulate an intranasal delivery system for the essential oil in an aqueous solution used in the form of nasal spray. From 450 g Radix Bupleuri was extracted the essential oil in the amount of about 0.2 ml, which was slightly water-soluble and viscous with low-fluidity. In order to dissolve the essential oil evenly in the aqueous solution, tween-80 (TW-80, used in 10% (w/v) solution), propylene glycol (PG) and diethylene glycol monoethyl ether (TC) were selected as the favorable solubilizing agents, whose amount was respectively determined by L16(4(5)) orthogonal design. An aqueous solution with clarity and no ciliotoxicity was prepared when TW-80 8% (v/v), PG 14.4% (v/v) and TC 14.4% (v/v) were added. Employed to evaluate the acute toxicity, the rats grew well and were kept active and healthy within 14 d after an intranasal administration of this preparation at the dose of oil from 10 g Bupleuri/kg (50-fold higher than the clinical dose), indicating that there would be no serious toxicity at the normal dose. Intranasal administration of this preparation to 2 kg rabbits with fever induced by subcutaneous injection of turpentine decreased body temperature markedly (0.5, 0.8 and 1.0 degrees C respectively at the dose of oil from 1, 2 and 4 g Bupleuri/body). In addition, the administration significantly reduced fever in 200 g rats induced by intramuscular injection of colicine suspension (0.6 degrees C at the dose of oil from 0.8 g Bupleuri/body). The results suggest that the formulation of nasal spray for the essential oil from Radix Bupleuri can be potentially effective in the treatment of fever. PMID:16394548

  11. Evaluation of efficacy of four pediculicides against head louse (Pediculus capitis) infestation.

    PubMed

    Fan, P C; Chung, W C; Kuo, C L; Lin, C Y; Hsu, H M; Chuang, C H; Chow, C Y

    1992-05-01

    To evaluate the efficacy and to determine the minimum effective dosage of four pediculicides against head louse infestation, as well as to select a safe, effective, practical, and cheap agent, 1,657 infested school children in 25 primary schools in Szu-Hu, Kou-Hu, and Ku-Keng Districts of Yunlin County were treated and 1,611 of them were examined. The overall cure rate was 73% and the rate for boys (84%) was higher than that for girls (71%). The cure rate of Nix (permethrin 1%) cream rinse was 81%. The cure rate for single dosages of 1, 2, 3 and 4 cases/tube (56 gm/tube) was 87%, 83%, 81% and 71%, respectively. The cure rate of Para aerosol (bioallethrine 0.66%) was 78%. The cure rate for single dosages of 30 and 40 cases/tube (90 gm/tube) was 87% and 70%, respectively. The cure rate of Prioderm (malathion 1%) cream shampoo was 64%. The cure rate for single dosages of 10, 15 and 20 cases/tube (40 gm/tube) was 74%, 71% and 52%, respectively. The cure rate of Delice (1% gamma benzene hexachloride) was 71%. The cure rate for single dosages of 5 and 10 ml/case was 64% and 76%, respectively. Of the 226 infested girls, 181 (80%) were found to be infested with 1-10 head lice, 33 (15%) with 11-50 lice, 7(3%) with 51-100 lice and 5 (2%) with over 100 lice. Of the 2,160 head lice collected, 1,788 (83%) were nymphs, 284 (13%) females, and 88 (4%) males. The mean number of head lice in each infested girl was 10 (range 1-137). The low cure rates obtained in the present study may be due to the fact that many school girl & have long hair. In comparison, Nix had the highest cure rate (81%) but the highest price (NT$ 120/case). The cure rate and price of Para aerosol (78%, NT$ 7.2/case) and Delice (71%, NT$ 16.7/case) came next. Prioderm (64%, NT$ 10.0/case) had the lowest rate and a slight offensive smell. Preliminary trials show that based on the cost-effectiveness, Para aerosol is best in head louse infestation control.

  12. 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…

  13. 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

  14. 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,…

  15. 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.…

  16. 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…

  17. 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…

  18. Evaluating the Efficacy of Photodynamic Therapy with 20% Aminolevulinic Acid and Microdermabrasion as a Combination Treatment Regimen for Acne Scarring

    PubMed Central

    Jim On, Shelbi; Haddican, Madelaine; Singer, Giselle; Shim-Chang, Helen

    2014-01-01

    Acne scarring is a consequence of abnormal resolution of wound healing after damage that occurs in the sebaceous follicle during acne inflammation. No trial to date has evaluated the efficacy of the combination of microdermabrasion and photodynamic therapy for acne scarring. This single-center, double-blinded pilot study enrolled subjects with moderate-to-severe acne scarring who were randomly assigned in a blinded fashion to use aminolevulinic acid and vehicle in a split-face fashion after full-face treatment with microdermabrasion. On average, 80 percent of the patients displayed more improvement in scarring on the aminolevulinic acid split face versus the vehicle split face after five treatments. Using two different noninvasive mechanisms of targeting acne scarring provided for a safe treatment regimen characterized by more efficacious results with respect to higher rates of scarring improvement. PMID:24847407

  19. 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

  20. 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.

  1. A prospective evaluation of 2 different pain management protocols for total hip arthroplasty.

    PubMed

    Post, Zachary D; Restrepo, Camilo; Kahl, Lauren K; van de Leur, Tim; Purtill, James J; Hozack, William J

    2010-04-01

    Pain management after total hip arthroplasty has improved dramatically in the past decade. However, most protocols use opioid medications for pain control. In the current study, 100 patients were prospectively selected to receive a traditional narcotic-based patient-controlled analgesia protocol or a nonnarcotic oral protocol for pain management after primary total hip arthroplasty. Therapy programs were similar for both groups. Postoperatively, patients were followed daily for opioid use, medication adverse effects, pain control, and overall satisfaction. The nonnarcotic oral group showed lower mean pain scores during the first 24 hours after surgery. The satisfaction rate was high in both groups. Both protocols provided adequate pain control after total hip arthroplasty; the nonnarcotic pain management protocol resulted in significantly decreased opioid consumption and fewer adverse effects.

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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

  7. 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

  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 multicenter, prospective evaluation of quality of care and mortality in Japan based on the Surviving Sepsis Campaign guidelines.

    PubMed

    Fujishima, Seitaro; Gando, Satoshi; Saitoh, Daizoh; Mayumi, Toshihiko; Kushimoto, Shigeki; Shiraishi, Shin-Ichiro; Ogura, Hiroshi; Takuma, Kiyotsugu; Kotani, Joji; Ikeda, Hiroto; Yamashita, Norio; Suzuki, Koichiro; Tsuruta, Ryosuke; Takeyama, Naoshi; Araki, Tsunetoshi; Suzuki, Yasushi; Miki, Yasuo; Yamaguchi, Yoshihiro; Aikawa, Naoki

    2014-02-01

    To elucidate the standard Surviving Sepsis Campaign (SSC) guidelines-based quality of care and mortality related to severe sepsis in Japan, we conducted a multicenter, prospective, observational study using a new web-based database between June 1, 2010, and December 31, 2011. A total of 1104 patients with severe sepsis were enrolled from 39 Japanese emergency and critical care centers. All-cause hospital mortality was 29.3% in patients with severe sepsis and 40.7% in patients with septic shock. Pulmonary, renal, hepatic, and hematological dysfunctions were associated with significantly higher mortality, and hematological dysfunction, especially coagulopathy, was associated with the highest odds ratio for mortality. Compliance with severe sepsis bundles in our study was generally low compared with that in a previous international sepsis registry study, and glycemic control was associated with lowest odds ratio for mortality. Despite higher complication rates of multiple organ dysfunction syndrome and low compliance with severe sepsis bundles on the whole, mortality in our study was similar to that in the international sepsis registry study. From these results, we concluded that our prospective multicenter study was successful in evaluating SSC guidelines-based standard quality of care and mortality related to severe sepsis in Japan. Although mortality in Japan was equivalent to that reported worldwide in the above-mentioned international sepsis registry study, compliance with severe sepsis bundles was low. Thus, there is scope for improvement in the initial treatment of severe sepsis and septic shock in Japanese emergency and critical care centers.

  10. 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

  11. 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

  12. 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.

  13. 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

  14. 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

  15. The Effect of Problem Posing Oriented Analyses-II Course on the Attitudes toward Mathematics and Mathematics Self-Efficacy of Elementary Prospective Mathematics Teachers

    ERIC Educational Resources Information Center

    Akay, Hayri; Boz, Nihat

    2010-01-01

    Research on mathematics teaching and learning has recently focused on affective variables, which were found to play an essential role that influences behaviour and learning. Despite its importance, problem posing has not yet received the attention it warrants from the mathematics education community. Perceived self-efficacy beliefs have been found…

  16. 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

  17. Comparative Studies Evaluating Mouse Models Used for Efficacy Testing of Experimental Drugs against Mycobacterium tuberculosis▿

    PubMed Central

    De Groote, Mary A.; Gilliland, Janet C.; Wells, Colby L.; Brooks, Elizabeth J.; Woolhiser, Lisa K.; Gruppo, Veronica; Peloquin, Charles A.; Orme, Ian M.; Lenaerts, Anne J.

    2011-01-01

    Methodologies for preclinical animal model testing of drugs against Mycobacterium tuberculosis vary from laboratory to laboratory; however, it is unknown if these variations result in different outcomes. Thus, a series of head-to-head comparisons of drug regimens in three commonly used mouse models (intravenous, a low-dose aerosol, and a high-dose aerosol infection model) and in two strains of mice are reported here. Treatment with standard tuberculosis (TB) drugs resulted in similar efficacies in two mouse species after a low-dose aerosol infection. When comparing the three different infection models, the efficacies in mice of rifampin and pyrazinamide were similar when administered with either isoniazid or moxifloxacin. Relapse studies revealed that the standard drug regimen showed a significantly higher relapse rate than the moxifloxacin-containing regimen. In fact, 4 months of the moxifloxacin-containing combination regimen showed similar relapse rates as 6 months of the standard regimen. The intravenous model showed slower bactericidal killing kinetics with the combination regimens tested and a higher relapse of infection than either aerosol infection models. All three models showed similar outcomes for in vivo efficacy and relapse of infection for the drug combinations tested, regardless of the mouse infection model used. Efficacy data for the drug combinations used also showed similar results, regardless of the formulation used for rifampin or timing of the drugs administered in combination. In all three infection models, the dual combination of rifampin and pyrazinamide was less sterilizing than the standard three-drug regimen, and therefore the results do not support the previously reported antagonism between standard TB agents. PMID:21135176

  18. 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

  19. 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

  20. 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

  1. Design and prospective evaluation of a risk-based surveillance system for shrimp grow-out farms in northeast Brazil.

    PubMed

    Marques, Ana Rita; Pereira, Marcelo; Ferreira Neto, Jose Soares; Ferreira, Fernando

    2015-12-01

    The farming of Pacific white shrimp Litopennaeus vannamei in northeast Brazil, has proven to be a promising sector. However, the farming of Pacific white shrimp in Brazil has been affected negatively by the occurrence of viral diseases, threatening this sector's expansion and sustainability. For this reason, the drafting of a surveillance system for early detection and definition of freedom from viral diseases, whose occurrence could result in high economic loses, is of the utmost importance. The stochastic model AquaVigil was implemented to prospectively evaluate different surveillance strategies to determine freedom from disease and identify the strategy with the lowest sampling efforts, making the best use of available resources through risk-based surveillance. The worked example presented was designed for regional application for the state of Ceará and can easily be applied to other Brazilian states. The AquaVigil model can analyse any risk-based surveillance system that considers a similar outline to the strategy here presented.

  2. 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

  3. 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.

  4. 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.

  5. Evaluation of noninvasive tests for the preoperative staging of carcinoma of the esophagus: a prospective study

    SciTech Connect

    Inculet, R.I.; Keller, S.M.; Dwyer, A.; Roth, J.A.

    1985-12-01

    A prospective study was undertaken to define the usefulness of conventional full-lung linear tomography, radionuclide liver plus spleen and bone scans, and thoracic and abdominal computed tomography for the preoperative staging of carcinoma of the esophagus. Thirty-three patients with carcinoma of the esophagus were studied. The computed tomographic (CT) scan of the thorax and upper abdomen was the single most accurate noninvasive study. With computed tomography, the relationship of the tumor to the tracheobronchial tree was the feature most useful in predicting local resectability. In all patients with the finding of tracheobronchial compression by the tumor, the tumor could not be resected completely. The predictive value of this CT finding in patients with locally unresectable tumor was high (0.83), indicating its usefulness in assessing unresectability. The CT finding of visible separation between tumor mass and tracheobronchial tree was present in 10 of 14 patients with locally resectable tumor (predictive value, 0.63). However, tumor abutting the tracheobronchial tree without compression was a poor predictor of unresectability (predictive value, 0.36). The radionuclide bone scan was the only other noninvasive study to demonstrate a metastasis not evident by CT scan. The combination of chest and abdominal CT scan, bone scan, and bronchoscopy before operation will accurately stage the majority of patients with esophageal cancer but no noninvasive test is of sufficient reliability to exclude patients from operative resection if otherwise indicated.

  6. 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.

  7. Preliminary geological and geophysical evaluation of the Castle Dome HDR geothermal prospect, Southwestern Arizona

    SciTech Connect

    Gutmann, J.T.; Aiken, C.L.V.; Ander, M.E.; Laney, R.T.

    1980-01-01

    The Castle Dome HDR geothermal prospect is located in Yuma County, Arizona, in a region centered about 80 km north of Yuma along US Rte. 95. The area of interest is broadly defined by a negative residual Bouguer gravity anomaly which is about 45 km across, steep-sided in many places, and as much as 30 mgals in magnitude. The geology of this Basin and Range area is poorly known, but the few published reports and current Los Alamos Scientific Laboratory (LASL) field studies indicate that the Castle Dome Mountains and adjacent ranges are chiefly a thick pile of welded ash-flow tuffs of probable mid-Tertiary age. The tuffs rest unconformably on Mesozoic metasedimentary rocks exposed only outside steep edges of the gravity low. This gravity anomaly may reflect the presence of a large caldera. A regional magnetotelluric study now in progress will define the depths to electrical conductors within the crust and upper mantle and contribute to understanding of crustal structure, the gravity anomaly, and the Hot Dry Rock (HDR) geothermal potential of the Castle Dome area.

  8. 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

  9. Acute bleeding varices: a five-year prospective evaluation of tamponade and sclerotherapy.

    PubMed Central

    Terblanche, J; Yakoob, H I; Bornman, P C; Stiegmann, G V; Bane, R; Jonker, M; Wright, J; Kirsch, R

    1981-01-01

    In a five-year study of massive upper gastrointestinal hemorrhage, 143 patients had esophageal varices diagnosed on emergency endoscopic examination. Seventy-one patients had active bleeding from varices and required Sengstaken tube tamponade during at least one hospital admission. The remaining patients included 33 with variceal bleeding which had stopped and 39 who were bleeding from another source. Sixty-six of the former group of 71 patients were referred for emergency injection sclerotherapy. These 66 patients were followed prospectively to August 1980, and had 137 episodes of endoscopically proven variceal bleeding requiring Sengstaken tube control followed by injection sclerotherapy during 93 separate hospital admissions. Definitive control of hemorrhage was achieved in 95% the patients admitted to the hospital (single injection 70%; two or three injections 22%). The death rate per hospital admission was 28%. No patient died of continued variceal bleeding, and exsanguinating variceal hemorrhage no longer poses a major problem at our hospital. The combined use of initial Sengstaken tube tamponade followed by injection sclerotherapy has simplified emergency treatment in the group of patients who continue to bleed actively from esophageal varices, despite initial conservative treatment. Images Fig. 1. PMID:7025770

  10. 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.

  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. A DOUBLE-BLIND, CONTROLLED EVALUATION OF THE EFFICACY AND ADVERSE EFFECT PROFILE OF SUSTAINED-RELEASE ALPRAZOLAM

    PubMed Central

    Andrade, Chittaranjan; Aswath, Anitha; Chaturvedi, S.K.; Raguram, R.; Bhide, Ajit

    2000-01-01

    In a double-blind, prospective study, 40 patients diagnosed with DSM-IV generalized anxiety disorder and stabilized on alprazolam therapy were randomized to receive the same dose of either conventional or sustained-released alprazolam for two weeks, followed by the other formulation of alprazolam in an identical dose for a further two weeks. Conventional alprazolam was administered thrice daily while the sustained-release formulation was administered once-daily, in the morning. Thirty four patients completed the study. Recruitment into the study was associated with a significant decrease in all measures of illness severity; however, no efficacy differences between the two forms of alprazolam were observed. Adverse effects, specifically insomnia, were reported more with the sustained-release formulation. It is concluded that once-daily sustained-release alprazolam is as effective as the conventional form of the drug, and may be preferable because of a wide range of advantages; in this study, the higher incidence of adverse effects with the sustained-release drug was probably an artefact of the experimental design, which fostered a (nighttime) state of partial drug withdrawal. PMID:21407961

  13. 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.

  14. A prospective fMRI-based technique for localising the epileptogenic zone in presurgical evaluation of epilepsy.

    PubMed

    Hunyadi, Borbála; Tousseyn, Simon; Dupont, Patrick; Van Huffel, Sabine; De Vos, Maarten; Van Paesschen, Wim

    2015-06-01

    There is growing evidence for the benefits of simultaneous EEG-fMRI as a non-invasive localising tool in the presurgical evaluation of epilepsy. However, many EEG-fMRI studies fail due to the absence of interictal epileptic discharges (IEDs) on EEG. Here we present an algorithm which makes use of fMRI as sole modality to localise the epileptogenic zone (EZ). Recent studies using various model-based or data-driven fMRI analysis techniques showed that it is feasible to find activation maps which are helpful in the detection of the EZ. However, there is lack of evidence that these techniques can be used prospectively, due to (a) their low specificity, (b) selecting multiple activation maps, or (c) a widespread epileptic network indicated by the selected maps. In the current study we present a method based on independent component analysis and a cascade of classifiers that exclusively detects a single map related to interictal epileptic brain activity. In order to establish the sensitivity and specificity of the proposed method, it was evaluated on a group of 18 EEG-negative patients with a single well-defined EZ and 13 healthy controls. The results show that our method provides maps which correctly indicate the EZ in several (N=4) EEG-negative cases but at the same time maintaining a high specificity (92%). We conclude that our fMRI-based approach can be used in a prospective manner, and can extend the applicability of fMRI to EEG-negative cases.

  15. 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%.

  16. Evaluating the safety and efficacy of dextromethorphan/quinidine in the treatment of pseudobulbar affect

    PubMed Central

    Schoedel, Kerri A; Morrow, Sarah A; Sellers, Edward M

    2014-01-01

    Pseudobulbar affect (PBA) is a common manifestation of brain pathology associated with many neurological diseases, including amyotrophic lateral sclerosis, Alzheimer’s disease, stroke, multiple sclerosis, Parkinson’s disease, and traumatic brain injury. PBA is defined by involuntary and uncontrollable expressed emotion that is exaggerated and inappropriate, and also incongruent with the underlying emotional state. Dextromethorphan/quinidine (DM/Q) is a combination product indicated for the treatment of PBA. The quinidine component of DM/Q inhibits the cytochrome P450 2D6-mediated metabolic conversion of dextromethorphan to its active metabolite dextrorphan, thereby increasing dextromethorphan systemic bioavailability and driving the pharmacology toward that of the parent drug and away from adverse effects of the dextrorphan metabolite. Three published efficacy and safety studies support the use of DM/Q in the treatment of PBA; significant effects were seen on the primary end point, the Center for Neurologic Study-Lability Scale, as well as secondary efficacy end points and quality of life. While concentration–effect relationships appear relatively weak for efficacy parameters, concentrations of DM/Q may have an impact on safety. Some special safety concerns exist with DM/Q, primarily because of the drug interaction and QT prolongation potential of the quinidine component. However, because concentrations of dextrorphan (which is responsible for many of the parent drug’s side effects) and quinidine are lower than those observed in clinical practice with these drugs administered alone, some of the perceived safety issues may not be as relevant with this low dose combination product. However, since patients with PBA have a variety of other medical problems and are on numerous other medications, they may not tolerate DM/Q adverse effects, or may be at risk for drug interactions. Some caution is warranted when initiating DM/Q treatment, particularly in patients

  17. Prospective evaluation of methylated SEPT9 in plasma for detection of asymptomatic colorectal cancer

    PubMed Central

    Church, Timothy Robert; Wandell, Michael; Lofton-Day, Catherine; Mongin, Steven J; Burger, Matthias; Payne, Shannon R; Castaños-Vélez, Esmeralda; Blumenstein, Brent A; Rösch, Thomas; Osborn, Neal; Snover, Dale; Day, Robert W; Ransohoff, David F

    2014-01-01

    Background As screening methods for colorectal cancer (CRC) are limited by uptake and adherence, further options are sought. A blood test might increase both, but none has yet been tested in a screening setting. Objective We prospectively assessed the accuracy of circulating methylated SEPT9 DNA (mSEPT9) for detecting CRC in a screening population. Design Asymptomatic individuals ≥50 years old scheduled for screening colonoscopy at 32 US and German clinics voluntarily gave blood plasma samples before colon preparation. Using a commercially available assay, three independent blinded laboratories assayed plasma DNA of all CRC cases and a stratified random sample of other subjects in duplicate real time PCRs. The primary outcomes measures were standardised for overall sensitivity and specificity estimates. Results 7941 men (45%) and women (55%), mean age 60 years, enrolled. Results from 53 CRC cases and from 1457 subjects without CRC yielded a standardised sensitivity of 48.2% (95% CI 32.4% to 63.6%; crude rate 50.9%); for CRC stages I–IV, values were 35.0%, 63.0%, 46.0% and 77.4%, respectively. Specificity was 91.5% (95% CI 89.7% to 93.1%; crude rate 91.4%). Sensitivity for advanced adenomas was low (11.2%). Conclusions Our study using the blood based mSEPT9 test showed that CRC signal in blood can be detected in asymptomatic average risk individuals undergoing screening. However, the utility of the test for population screening for CRC will require improved sensitivity for detection of early cancers and advanced adenomas. Clinical Trial Registration Number: NCT00855348 PMID:23408352

  18. PROspective Multicenter Imaging Study for Evaluation of Chest Pain: Rationale and Design of the PROMISE Trial

    PubMed Central

    Douglas, Pamela S.; Hoffmann, Udo; Lee, Kerry L.; Mark, Daniel B.; Al-Khalidi, Hussein R.; Anstrom, Kevin; Dolor, Rowena J.; Kosinski, Andrzej; Krucoff, Mitchell W.; Mudrick, Daniel W.; Patel, Manesh R.; Picard, Michael H.; Udelson, James E.; Velazquez, Eric J.; Cooper, Lawton

    2014-01-01

    Background Suspected coronary artery disease (CAD) is one of the most common, potentially life threatening diagnostic problems clinicians encounter. However, no large outcome-based randomized trials have been performed to guide the selection of diagnostic strategies for these patients. Methods The PROMISE study is a prospective, randomized trial comparing the effectiveness of two initial diagnostic strategies in patients with symptoms suspicious for CAD. Patients are randomized to either: 1) functional testing (exercise electrocardiogram, stress nuclear imaging, or stress echocardiogram); or 2) anatomic testing with >=64 slice multidetector coronary computed tomographic angiography. Tests are interpreted locally in real time by subspecialty certified physicians and all subsequent care decisions are made by the clinical care team. Sites are provided results of central core lab quality and completeness assessment. All subjects are followed for ≥1 year. The primary end-point is the time to occurrence of the composite of death, myocardial infarction, major procedural complications (stroke, major bleeding, anaphylaxis and renal failure) or hospitalization for unstable angina. Results Over 10,000 symptomatic subjects were randomized in 3.2 years at 193 US and Canadian cardiology, radiology, primary care, urgent care and anesthesiology sites. Conclusion Multi-specialty community practice enrollment into a large pragmatic trial of diagnostic testing strategies is both feasible and efficient. PROMISE will compare the clinical effectiveness of an initial strategy of functional testing against an initial strategy of anatomic testing in symptomatic patients with suspected CAD. Quality of life, resource use, cost effectiveness and radiation exposure will be assessed. Clinical trials.gov identifier NCT01174550 PMID:24890527

  19. Prospective study of Campylobacter jejuni infection in Chilean infants evaluated by culture and serology.

    PubMed

    Figueroa, G; Galeno, H; Troncoso, M; Toledo, S; Soto, V

    1989-05-01

    A prospective study of Campylobacter jejuni infection was performed during a 6-month period in a cohort of 198 Chilean infants. Surveillance was based on biweekly home visits by a team of trained nurses. C. jejuni colonization was studied by culturing stool samples from diarrheal episodes and paired asymptomatic controls and by performing an enzyme-linked immunosorbent assay developed to measure C. jejuni outer membrane protein polyvalent antibodies in a representative group of infants. C. jejuni was isolated from 30 of 299 diarrheal episodes (10%) and from 17 of 304 samples from asymptomatic infants (6%). Significantly higher (P less than 0.05) C. jejuni illness/infection ratios were found in infants less than 9 months old. Polyvalent antibodies to C. jejuni were found in 27 of 89 serum samples (30%). The lowest prevalence (4%) was observed among infants less than 9 months old, and the highest was found in patients older than 15 months (63%; P less than 0.01). Data obtained by analysis of paired serum samples revealed a significant increase in the number of seropositive individuals, from 8% on admission to 50% at the end of the protocol (P less than 0.001). The change in the immune status of these infants was associated with symptomatic infection in 9 of 18 cases. The antibody rise found in the remaining nine infants suggested the presence of asymptomatic C. jejuni infections. This inference was documented by the isolation of C. jejuni from stools of two of these infants when the infants were randomly studied while asymptomatic. This study points out the impact of C. jejuni-associated diarrheal episodes and the high frequency with which asymptomatic infections elicit specific antibodies in infants living in areas such as Chile.

  20. Evaluation of the Insecticidal Efficacy of Wild Type and Recombinant Baculoviruses.

    PubMed

    Popham, Holly J R; Ellersieck, Mark R; Li, Huarong; Bonning, Bryony C

    2016-01-01

    A considerable amount of work has been undertaken to genetically enhance the efficacy of baculovirus insecticides. Following construction of a genetically altered baculovirus, laboratory bioassays are used to quantify various parameters of insecticidal activity such as the median lethal concentration (or dose) required to kill 50 % of infected larvae (LC50 or LD50), median survival of larvae infected (ST50), and feeding damage incurred by infected larvae. In this chapter, protocols are described for a variety of bioassays and the corresponding data analyses for assessment of the insecticidal activity of baculovirus insecticides.

  1. 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.

  2. A phase II study evaluating the toxicity and efficacy of single-agent temsirolimus in chemotherapy-naïve castration-resistant prostate cancer

    PubMed Central

    Kruczek, K; Ratterman, M; Tolzien, K; Sulo, S; Lestingi, T M; Nabhan, C

    2013-01-01

    Background: The mammalian target of rapamycin (mTOR) pathway is deregulated in castration-resistant prostate cancer (CRPC). We investigated the efficacy and toxicity of temsirolimus, an mTOR inhibitor, in chemotherapy-naïve CRPC. Methods: In this phase II open label study, eligible patients received IV temsirolimus at 25 mg weekly until objective disease progression, unacceptable toxicity or investigator's discretion. Toxicity was assessed every 4 weeks and responses every 8 weeks. Primary end point was calculating the overall response (OR) rate as well as measuring stable disease (SD) to assess the overall clinical benefit calculated as OR+SD. Secondary end points included prostatic-specific antigen (PSA) changes and time to progression biochemically and radiographically. Correlative studies included prospective assessment of quality of life (QoL) using two previously validated scales. Results: Although the sponsor halted the study early, 21 patients were enrolled of which, 15 were evaluable for efficacy and OR. Median age was 74 (range: 57–89), median PSA was 237.5 ng ml−1 (range: 8.2–2360), visceral disease present in 11 patients (52%), and 17 patients (81%) patients had Gleason score (7–10). Two patients had a partial response (PR) and eight had SD. The OR was 13% (2/15) and the overall clinical benefit (OR+SD) was 67% (10/15). Median time to radiographic disease progression was 2 months (range 2–10 months). Biochemical response assessment was available for 14/15 patients. Any PSA decline was observed in four patients (28.5% 4/14) with one patient (7%) having >50% PSA decline. Median time to progression by PSA was 2 months (range 1–10 months). With a median follow-up of 32 months, median overall survival (OS) was 13 months (range: 2–37) and three patients remain alive at the data cutoff (5/2013) for an OS of 14% at 4 years on an intent-to-treat analysis. Major non-haematologic toxicities included fatigue (19%) and pneumonia (14%). Main

  3. 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

  4. Evaluation of nitazoxanide and oxfendazole efficacy against cystic echinococcosis in naturally infected sheep.

    PubMed

    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

    2009-03-01

    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 (NTZ5x2) 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.

  5. 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

  6. 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

  7. 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

  8. 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

  9. Efficacy evaluations of the use of oral tilmicosin in pneumonic calves.

    PubMed

    Fodor, L; Reeve-Johnson, L; Hodge, A; Varga, J

    2000-03-01

    The therapeutic effect of oral tilmicosin was compared with enrofloxacin, and the efficacy of three doses of the drug was examined in two fully randomized blinded field trials. Pneumonic milk-fed calves between 3 days and 2.5 months of age were allocated into two groups in trial 1 (50 animals) and into three groups in trial 2 (69 calves). In the first trial, the animals were treated with 25 mg/kg/day tilmicosin or 2.5 mg/kg/day enrofloxacin in milk for 5 days. In the second trial, the calves received either 25 mg/kg/day tilmicosin for 5 days or 3 days, or else 12.5 mg/kg tilmicosin for 5 days. All calves were clinically examined for 10 days. In the first trial, oral tilmicosin at a dose of 25 mg/kg/day for 5 days proved to be effective for the treatment of endemic pasteurellosis of milk-fed calves. The efficacy was the same as that of enrofloxacin. All three doses in the second trial were effective and were statistically equivalent to the original dose tested.

  10. Microbiological evaluation of the efficacy of two new biodetergents on multidrug-resistant nosocomial pathogens

    PubMed Central

    2009-01-01

    Background In the last few years, several outbreaks of nosocomial infections caused by multidrug-resistant pathogenic agents have been observed, and various biocides products were developed in order to control this phenomenon. We investigated the efficacy of two natural biodetergents composed of plants and kelps extracts, BATT1 and BATT2, against multidrug-resistant strains. Methods In-vitro antibacterial efficacy of BATT1 and BATT2 against nosocomial multidrug-resistant isolates was assessed using a suspension-inhibition test, with and without bovine serum albumin (BSA). The test was also carried out on glass surfaces with and without BSA. Results In vitro tests with both biocidal disinfectants at 25% concentration demonstrated an overall drop in bacterial, mould and yeast counts after 10 min of contact with or without organic substances. For Pseudomonas aeruginosa, it was necessary to use undiluted disinfectants with and without an organic substance. The same results were obtained in tests carried out on glass surfaces for all strains. Conclusions The natural products BATT1 and BATT2 behave like good biocides even in presence of organic substances. The use of both disinfectants may be beneficial for reducing hospital-acquired pathogens that are not susceptible to disinfectants. However, it has to be stressed that all these experiments were carried out in vitro and they still require validation from use in clinical practice. PMID:20015394

  11. 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.

  12. Evaluation of the Efficacy And Toxicity of RNAs Targeting HIV-1 Production for Use in Gene or Drug Therapy.

    PubMed

    Scarborough, Robert J; Adams, Kelsey L; Del Corpo, Olivier; Daher, Aïcha; Gatignol, Anne

    2016-01-01

    Small RNA therapies targeting post-integration steps in the HIV-1 replication cycle are among the top candidates for gene therapy and have the potential to be used as drug therapies for HIV-1 infection. Post-integration inhibitors include ribozymes, short hairpin (sh) RNAs, small interfering (si) RNAs, U1 interference (U1i) RNAs and RNA aptamers. Many of these have been identified using transient co-transfection assays with an HIV-1 expression plasmid and some have advanced to clinical trials. In addition to measures of efficacy, small RNAs have been evaluated for their potential to affect the expression of human RNAs, alter cell growth and/or differentiation, and elicit innate immune responses. In the protocols described here, a set of transient transfection assays designed to evaluate the efficacy and toxicity of RNA molecules targeting post-integration steps in the HIV-1 replication cycle are described. We have used these assays to identify new ribozymes and optimize the format of shRNAs and siRNAs targeting HIV-1 RNA. The methods provide a quick set of assays that are useful for screening new anti-HIV-1 RNAs and could be adapted to screen other post-integration inhibitors of HIV-1 replication. PMID:27684275

  13. Prospective evaluation of indirect costs due to acute rotavirus gastroenteritis in Spain: the ROTACOST study

    PubMed Central

    2011-01-01

    Background The effect of rotavirus in developed countries is mainly economic. This study aimed to assess the indirect costs induced by rotavirus acute gastroenteritis (RVAGE) in Spain. Methods A prospective observational study was conducted from October 2008 to June 2009. It included 682 children up to 5 years of age with acute gastroenteritis (AGE) who attended primary care (n = 18) and emergency room/hospital settings (n = 10), covering the regions of Galicia and Asturias (North-west Spain). All non-medical expenses incurred throughout the episode were recorded in detail using personal interviews and telephone contact. Results Among the 682 enrolled children, 207 (30.4%) were rotavirus positive and 170 (25%) had received at least one dose of rotavirus vaccine. The mean (standard deviation) indirect cost caused by an episode of AGE was estimated at 135.17 (182.70) Euros. Costs were 1.74-fold higher when AGE was caused by rotavirus compared with other etiologies: 192.7 (219.8) Euros vs. 111.6 (163.5) Euros (p < .001). The costs for absenteeism were the most substantial with a mean of 91.41 (134.76) Euros per family, resulting in a loss of 2.45 (3.17) days of work. In RVAGE patients, the absenteeism cost was 120.4 (154) Euros compared with 75.8 (123) for the other etiologies (p = .002), because of loss of 3.5 (3.6) vs 1.9 (2.9) days of work (p < .001). Meals costs were 2-fold-higher (48.5 (55) vs 24.3 (46) Euros, p < .001) and travel costs were 2.6-fold-higher (32 (92) vs 12.5 (21.1) Euros, p = .005) in RVAGE patients compared with those with other etiologies. There were no differences between RVAGE and other etiologies groups regarding costs of hiring of caregivers or purchase of material. Patients with RVAGE were admitted to hospital more frequently than those with other etiologies (47.8% vs 14%, p < .001). Conclusions Rotavirus generates a significant indirect economic burden. Our data should be considered in the decision-making process of the eventual inclusion

  14. Four-year prospective evaluation of the relationship between meaning in life and smoking status

    PubMed Central

    2013-01-01

    Background To date, all investigations on the relationship between smoking and perceived level of meaning in life have used cross-sectional designs. Therefore, the purpose of the present prospective study, conducted with a four-year time lag, was to test the predictive power of the life meaning construct concerning changes in smoking status. Methods The data of 4,294 respondents (40.3% male, Mage = 54.7 ± 16.5 yrs) from the Hungarian Epidemiological Panel Survey were analyzed using the Kruskal-Wallis and Mann–Whitney U-test and structural equation modeling (SEM) with a nominal outcome variable. Gender, age, and educational level were included in the study as covariates. Results On the bivariate level, results showed that both baseline and follow-up meaning in life scores were higher in stable non-smokers when compared to stable smokers. However, quitters and starters differed from stable non-smokers in their baseline but not in follow-up life meaning scores. The other relationships (stable smokers vs. quitters; stable smokers vs. starters, starters vs. quitters) were non-significant in both time points. According to the SEM-analysis, a higher sense of meaning in life measured at baseline and follow-up is associated with a lower likelihood (OR = 0.54, z = 2.80, p = 0.005; OR = 0.64, z = 2.88, p = 0.004, respectively) of being a stable smoker compared to being a stable non-smoker, confirming the expected relationship between smoking and decreased level of meaning in life. However, neither baseline nor follow-up life meaning scores predicted significantly quitting and uptake of smoking. Conclusions If future research from other cultures verifies the protective role of a higher level of meaning in life against smoking, then smoking prevention and cessation programs will also have to include such components that help individuals experience more meaning in their lives. PMID:23433067

  15. [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

  16. Prospective Evaluation of Radiotherapy With Concurrent and Adjuvant Temozolomide in Children With Newly Diagnosed Diffuse Intrinsic Pontine Glioma

    SciTech Connect

    Jalali, Rakesh; Raut, Nirmal; Arora, Brijesh; Gupta, Tejpal; Dutta, Debnarayan; Munshi, Anusheel; Sarin, Rajiv; Kurkure, Purna

    2010-05-01

    Purpose: To present outcome data in a prospective study of radiotherapy (RT) with concurrent and adjuvant temozolomide (TMZ) in children with diffuse intrinsic pontine gliomas (DIPGs). Methods and Materials: Pediatric patients with newly diagnosed DIPGs were prospectively treated with focal RT to a dose of 54 Gy in 30 fractions along with concurrent daily TMZ (75 mg/m{sup 2}, Days 1-42). Four weeks after completing the initial RT-TMZ schedule, adjuvant TMZ (200 mg/m{sup 2}, Days 1-5) was given every 28 days to a maximum of 12 cycles. Response was evaluated clinically and radiologically with magnetic resonance imaging and positron emission tomography scans. Results: Between March 2005 and November 2006, 20 children (mean age, 8.3 years) were accrued. Eighteen patients have died from disease progression, one patient is alive with progressive disease, and one patient is alive with stable disease. Median overall survival and progression-free survival were 9.15 months and 6.9 months, respectively. Grade III/IV toxicity during the concurrent RT-TMZ phase included thrombocytopenia in 3 patients, leucopenia in 2, and vomiting in 7. Transient Grade II skin toxicity developed in the irradiated fields in 18 patients. During the adjuvant TMZ phase, Grade III/IV leucopenia developed in 2 patients and Grade IV thrombocytopenia in 1 patient. Patients with magnetic resonance imaging diagnosis of a high-grade tumor had worse survival than those with a low-grade tumor (p = 0.001). Patients with neurologic improvement after RT-TMZ had significantly better survival than those who did not (p = 0.048). Conclusions: TMZ with RT has not yielded any improvement in the outcome of DIPG compared with RT alone. Further clinical trials should explore novel treatment modalities.

  17. Prospective Evaluation of Visual Acuity Assessment: A Comparison of Snellen Versus ETDRS Charts in Clinical Practice (An AOS Thesis)

    PubMed Central

    Kaiser, Peter K.

    2009-01-01

    Purpose: The purpose of this study was twofold: first, to prospectively compare visual acuity (VA) scores obtained with Snellen charts versus Early Treatment Diabetic Retinopathy Study (ETDRS) charts in a “real world” retinal practice, and second, to see if there was a difference in visual acuity measurements obtained with ETDRS charts starting at 4 or 2 meters. Methods: Prospective, consecutive evaluation of patients who underwent best-corrected visual acuity testing of their right eye performed at a single seating by the same experienced, certified vision examiner in the same room with standardized low light conditions using a projected Snellen chart at 20 feet, and two different back-illuminated ETDRS charts placed 4 and 2 meters from the patient. Results: One hundred sixty-three eyes were included in the study. The mean Snellen VA was 0.67 logMAR (20/94), ETDRS VA at 4 meters was 0.54 logMAR (~20/69), and ETDRS VA at 2 meters was 0.51 logMAR (~20/65). The mean difference was 6.5 letters better on the ETDRS chart (P=.000000001). As the VA worsened, there was increased variability between the charts and the mean discrepancy between charts also increased. Subgroup analysis revealed the greatest difference between charts was in the poor vision subgroup (<20/200) with a difference of 0.2 logMAR (10 letters; P=.0000002). Patients with exudative age-related macular degeneration (AMD) had the greatest disparity on vision testing, but patients with dry AMD and diabetic retinopathy also exhibited significant differences. Conclusions: Visual acuity scores were significantly better on ETDRS charts compared to Snellen charts. The difference was greatest with poor visual acuity (<20/200) and in patients with exudative AMD. Thus, caution should be exercised when comparing data using the different charts. PMID:20126505

  18. 78 FR 21131 - Prospective Grant of An Exclusive Evaluation Option License: Pre-clinical Evaluation of Anti...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-09

    ... license, SPEED will have the right to execute an exclusive patent commercialization license which will... development plan at the time of conversion. DATES: Only written comments and/or applications for a license... exclusive evaluation option license, and a subsequent exclusive patent commercialization license, may...

  19. Do children prefer contingencies? An evaluation of the efficacy of and preference for contingent versus noncontingent social reinforcement during play.

    PubMed

    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 noncontingent reinforcement (NCR) schedules with typically developing children. Results showed that 7 of the 8 children preferred the DRA schedule; 1 child was indifferent. We also demonstrated a high degree of procedural fidelity, which suggested that preference is influenced by the presence of a contingency under which reinforcement can be obtained. These findings are discussed in terms of (a) the selection of reinforcement schedules in practice, (b) variables that influence children's preferences for contexts, and (c) the selection of experimental control procedures when evaluating the effects of reinforcement.

  20. An Evaluation of Attributes Sought by Prospective Business Majors at Private Colleges.

    ERIC Educational Resources Information Center

    Massad, Victor J.; Tucker, Joanne M.

    2000-01-01

    Discusses how much of the criticism toward the use of marketing theory in strategic planning for higher education is predicated on the idea that students are unqualified to evaluate the complex and long-term nuances of educational services. A survey of 157 high school seniors finds that students ranked academically related attributes higher in…

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