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Sample records for high clinical efficacy

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

    DEFF Research Database (Denmark)

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

    2011-01-01

    To cite this article: Howarth P, Malling H-J, Molimard M, Devillier P. Analysis of allergen immunotherapy studies shows increased clinical efficacy in highly symptomatic patients. Allergy 2012; 67: 321-327. ABSTRACT: Background:  The assessment of allergen immunotherapy (AIT) efficacy...... in the treatment for seasonal allergic rhinoconjunctivitis (SAR) symptoms is challenging. Allergen immunotherapy differs from symptomatic therapy in that while symptomatic therapy treats patients after symptoms appear and aims to reduce symptoms, AIT is administered before symptoms are present and aims to prevent...... them. Thus, clinical studies of AIT can neither establish baseline symptom levels nor limit the enrolment of patients to those with the most severe symptoms. Allergen immunotherapy treatment effects are therefore diluted by patients with low symptoms for a particular pollen season. The objective...

  2. Clinical Efficacy of Toric Orthokeratology in Myopic Ado-lescent with Moderate to High Astigmatism

    Institute of Scientific and Technical Information of China (English)

    Ming Luo; Shengsheng Ma; Na Liang

    2014-01-01

    Purpose:.To observe the efficacy of toric design orthokera-tology.(ortho-k).for correcting myopia and astigmatism in my-opic adolescents with moderate to high astigmatism. Methods:.This was a self-controlled clinical study..Twenty-four subjects(42 eyes).aged 9 to 16 years with myopia of 2.50-6.00 D complicated with rule astigmatism of 1.50-3.50 D were fitted with Lucid Night Toric Ortho-k Lenses (LUCID,KO-REA)..The changes in uncorrected visual acuity (UCVA), spherical degree, refraction, axial length (AL),.and corneal status were assessed at baseline, 1 night, 1 week, 1 month, 3 months, 6 months, and 1 year after the commencement of or-tho-k lens wear. Results: The success rate of the first lens fit was 92.8%. The UCVA after ortho-k wearing was improved significantly com-pared to the baseline during each visit (all P0.05)..Grade 1 corneal staining was observed at 1 week (23.8%),.1 month (21.4%), and 1 year (16.7%) fol-lowing lens wear, and was improved by lens cleaning,.discon-tinuing lens wear, and moistening the cornea with eye drops. No severe adverse events were reported. Conclusion: The toric ortho-k lens was effective and safe for correction of low to moderate myopia in children with moder-ate to high astigmatism..The lens also effectively controlled axial length elongation during 1 year of observation..However, the long-term efficacy remains to be elucidated.

  3. High levels of self-efficacy in patients with type 2 diabetes attending a tertiary level clinic

    Directory of Open Access Journals (Sweden)

    K. Mostert Wentzel

    2008-02-01

    Full Text Available Self-management is a vital element in the care of type 2diabetes patients.  In turn, self-efficacy plays a major role in patients’ self-management. Self-efficacy is the patient’s personal judgement of his/herconfidence in performing aspects of diabetes self-management.  This study investigated the level of self-efficacy of patients attending the Pretoria Academic Hospital Diabetes Clinic, in the light of high levels ofre-admission due to complications, suggesting low self-efficacy levels. Eighty type 2 diabetes patients, mean age of 59 years, completed thepublished IDEA LL baseline questionnaire, to establish a self-efficacyscore.  Relationships between self-efficacy and demographic factors wereinvestigated using the chi-square test. The mean self-efficacy level of thesample population is excellent (mean = 85.44%.A lthough self-reported self-efficacy levels are excellent, in comparison to the Sarkar study (2006 in which participants only scored “fair”, it is speculated that self-efficacy is not transferred to self-management behaviour in thispopulation.  Afrikaans and English speaking participants score significantly better than those from other language categories. There is a positive relationship between self-efficacy and level of education and employment status (tendedtowards significance with p values of 0.06 and 0.07 respectively. A lthough self-efficacy scores of clients at this tertiary level outpatient clinic are excellent, further research is necessary to quantify self-management strategies andto correlate these with self-efficacy levels.

  4. Clinical efficacy of entecavir combined with adefovir in chronic hepatitis B patients with high viral load

    Directory of Open Access Journals (Sweden)

    ZHANG Wen

    2014-11-01

    Full Text Available ObjectiveTo investigate the efficacy and safety of entecavir (ETV combined with adefovir (ADV in chronic hepatitis B (CHB patients with high viral load. MethodsEighty CHB patients with high viral load who were admitted to our hospital from December 2008 to December 2011 were equally and randomly divided into observation group and control group. The control group was given ETV, while the observation group was treated with ETV combined with ADV. HBV DNA load, HBsAg or HBeAg seroconversion, alanine aminotransferase (ALT normalization, and adverse reactions before and after 3, 6, 12, and 24 months of treatment were evaluated. Comparison of continuous data between the two groups was made by independent-samples t test, and comparison of categorical data was made by chi-square test. ResultsCompared with the control group, the observation group had significantly lower HBV DNA load after 6, 12, and 24 months of treatment (3.7±0.3 vs 3.4±0.4 log copies/ml, t=3.339, P<0.05; 2.9±0.4 vs 2.6±0.3 log copies/ml, t=5.657, P<0.05; 1.6±0.7 vs 1.2±0.4 log copies/ml, t=2.806, P<0.05. The HBV DNA clearance rate and HBeAg clearance rate in observation group were significantly higher than those in control group after 12 months of treatment (87.5% vs 70.0%, P<0.05; 80.0% vs 55.0%, P<0.05 and 24 months of treatment (95.0% vs 77.5%, P<0.05; 90.0% vs 70.0%, P<0.05. The observation group had significantly higher HBeAg seroconversion rate and ALT normalization rate than the control group after 24 months of treatment (77.5% vs 50.0%, P<0.05; 82.5% vs 55.0% P<005. During the treatment, there was no significant difference in the incidence of adverse reactions between the two groups (P>0.05, but the observation group had a significantly lower viral breakthrough rate than the control group (0 vs 10.0%, P<0.05. ConclusionFor CHB patients with high viral load, ETV combined with ADV has strong antiviral activity, reduces drug resistance and poor

  5. Efficacy of standard vs. extended intramammary cefquinome treatment of clinical mastitis in cows with persistent high somatic cell counts

    NARCIS (Netherlands)

    Swinkels, Jantijn M.; Krömker, Volker; Lam, Theo J G M

    2014-01-01

    Extended duration of clinical mastitis (CM) treatment has been advocated, although results showing its higher efficacy compared with standard treatment are difficult to compare and seem conflicting. In a non-blinded, positively controlled clinical trial with systematic allocation, the efficacy of a

  6. EVALUATION OF THE THERAPEUTIC EFFICACY OF HIGH-INTENSITY PULSED-PERIODIC LASER RADIATION (CLINICAL AND EXPERIMENTAL OBSERVATIONS

    Directory of Open Access Journals (Sweden)

    V. V. Sokolov

    2016-01-01

    Full Text Available From the experience of clinical observations, we have shown a high therapeutic effectiveness of the medical laser KULON-MED in: cosmetics, non-cancer inflammatory diseases of the gastrointestinal tract and cancer (cancer of the stomach and colon as at different wavelengths, and with different types of photosensitizers. In the area of anti-tumor photodynamic therapy (PDT, based on experimental studies, we have showed the high antitumor (sarcoma S‑37 effectiveness of the laser (with the inhibition of tumor growth of up to 100% for repetitively pulsed irradiation mode, and for mode fractionation doses laser radiation. In addition, significant differences are shown in the effectiveness of anticancer PDT methods in the application of high-intensity lasers, continuous and pulsed caused fundamental properties of laser radiation characteristics – time structure of the radiation pulses. Thus, for the first time we have shown that the time of high-intensity laser pulses structure significantly affects therapeutic efficacy laser system, and hence on the mechanisms of interaction of laser radiation with biological tissue.

  7. Increasing the clinical efficacy of NK and antibody-mediated cancer immunotherapy: potential predictors of successful clinical outcome observed in high-risk neuroblastoma

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    Tony A. Koehn

    2012-05-01

    Full Text Available Disease recurrence is frequent in high-risk neuroblastoma (NBL patients even after multimodality aggressive treatment [a combination of chemotherapy, surgical resection, local radiation therapy, autologous stem cell transplantation (ASCT and cis-retinoic acid (CRA]. Recent clinical studies have explored the use of monoclonal antibodies (mAbs that bind to disialoganglioside (GD2, highly expressed in NBL, as a means to enable immune effector cells to destroy NBL cells via antibody-dependent cell-mediated cytotoxicity (ADCC. Preclinical data indicate that ADCC can be more effective when appropriate effector cells are activated by cytokines. Clinical studies have pursued this by administering anti-GD2 mAb in combination with ADCC-enhancing cytokines (IL2 and GM-CSF, a regimen that has demonstrated improved cancer-free survival. More recently, early clinical studies have used a fusion protein that consists of the anti-GD2 mAb directly linked to IL2, and antitumor responses were seen in the Phase II setting. Analyses of genes that code for receptors that influence ADCC activity and Natural Killer (NK cell function [Fc Receptor (FcR, Killer Immunoglublin-like Receptor (KIR, and KIR-ligand (KIR-L] suggest patients with antitumor activity are more likely to have certain genotype profiles. Further analyses will need to be conducted to determine whether these genotypes can be used as predictive markers for favorable therapeutic outcome, thus potentially increasing the efficacy of mAb-mediated NK cell-based cancer immunotherapy.

  8. Clinical efficacy of photodynamic therapy

    Science.gov (United States)

    Park, Ye-Kyu

    2016-01-01

    Objective The management of cervical intraepithelial neoplasia (CIN) and early invasive cancer of the uterine cervix is very difficult to approach, especially in case of young woman who wants to preserve her fertility. Conization of the cervix may have various kinds of disadvantage. The objective of this clinical retrospective study is to investigate the therapeutic effects and clinical efficacy of photodynamic therapy (PDT) including combined chemo-photodynamic therapy in patients with pre-malignant CIN and malignant invasive cervical cancer. Methods Total number of PDT trial case was 50 cases and total number of patient was 22 patients who registered to PDT clinic. We used photogem sensitizer and 632 nm diode laser in early two cases. After then we performed PDT using photofrin sensitizer and 630 nm diode laser in other cases. We used flat-cut, microlens, cylindrical diffuser, and interstitial type optic fibers in order to irradiate the lesions. 240 J/cm2 energy was irradiated to the lesions. Results CIN 2 were 4 cases (18.2%) and CIN 3 were 15 (68.2%) and invasive cervical cancer were 3 (13.6%). Complete remission (CR) was found in 20 patients (91%). One case of 19 patients with CIN lesion recurred at 18 months after PDT treatment. CR was found in 18 cases in the patients with CIN lesions (95%). CR was found in 2 cases in the patients with invasive cervical cancer (67%). Conclusion Our data showed that CR rate was fantastic in CIN group (95%). This study suggests that PDT can be recommended as new optimistic management modality on the patients with pre-malignant CIN lesions including carcinoma in situ and relatively early invasive cancer of the uterine cervix. Combined chemo-photodynamic therapy is essential in case of invasive cervical cancer. For the young age group who desperately want to preserve their fertility and have a healthy baby, PDT can be a beacon of hope. PMID:27896250

  9. Clinical efficacy of photodynamic therapy.

    Science.gov (United States)

    Park, Ye-Kyu; Park, Choong-Hak

    2016-11-01

    The management of cervical intraepithelial neoplasia (CIN) and early invasive cancer of the uterine cervix is very difficult to approach, especially in case of young woman who wants to preserve her fertility. Conization of the cervix may have various kinds of disadvantage. The objective of this clinical retrospective study is to investigate the therapeutic effects and clinical efficacy of photodynamic therapy (PDT) including combined chemo-photodynamic therapy in patients with pre-malignant CIN and malignant invasive cervical cancer. Total number of PDT trial case was 50 cases and total number of patient was 22 patients who registered to PDT clinic. We used photogem sensitizer and 632 nm diode laser in early two cases. After then we performed PDT using photofrin sensitizer and 630 nm diode laser in other cases. We used flat-cut, microlens, cylindrical diffuser, and interstitial type optic fibers in order to irradiate the lesions. 240 J/cm(2) energy was irradiated to the lesions. CIN 2 were 4 cases (18.2%) and CIN 3 were 15 (68.2%) and invasive cervical cancer were 3 (13.6%). Complete remission (CR) was found in 20 patients (91%). One case of 19 patients with CIN lesion recurred at 18 months after PDT treatment. CR was found in 18 cases in the patients with CIN lesions (95%). CR was found in 2 cases in the patients with invasive cervical cancer (67%). Our data showed that CR rate was fantastic in CIN group (95%). This study suggests that PDT can be recommended as new optimistic management modality on the patients with pre-malignant CIN lesions including carcinoma in situ and relatively early invasive cancer of the uterine cervix. Combined chemo-photodynamic therapy is essential in case of invasive cervical cancer. For the young age group who desperately want to preserve their fertility and have a healthy baby, PDT can be a beacon of hope.

  10. Oxytocin efficacy is modulated by dosage and oxytocin receptor genotype in young adults with high-functioning autism: a 24-week randomized clinical trial

    Science.gov (United States)

    Kosaka, H; Okamoto, Y; Munesue, T; Yamasue, H; Inohara, K; Fujioka, T; Anme, T; Orisaka, M; Ishitobi, M; Jung, M; Fujisawa, T X; Tanaka, S; Arai, S; Asano, M; Saito, D N; Sadato, N; Tomoda, A; Omori, M; Sato, M; Okazawa, H; Higashida, H; Wada, Y

    2016-01-01

    Recent studies have suggested that long-term oxytocin administration can alleviate the symptoms of autism spectrum disorder (ASD); however, factors influencing its efficacy are still unclear. We conducted a single-center phase 2, pilot, randomized, double-blind, placebo-controlled, parallel-group, clinical trial in young adults with high-functioning ASD, to determine whether oxytocin dosage and genetic background of the oxytocin receptor affects oxytocin efficacy. This trial consisted of double-blind (12 weeks), open-label (12 weeks) and follow-up phases (8 weeks). To examine dose dependency, 60 participants were randomly assigned to high-dose (32 IU per day) or low-dose intranasal oxytocin (16 IU per day), or placebo groups during the double-blind phase. Next, we measured single-nucleotide polymorphisms (SNPs) in the oxytocin receptor gene (OXTR). In the intention-to-treat population, no outcomes were improved after oxytocin administration. However, in male participants, Clinical Global Impression-Improvement (CGI-I) scores in the high-dose group, but not the low-dose group, were significantly higher than in the placebo group. Furthermore, we examined whether oxytocin efficacy, reflected in the CGI-I scores, is influenced by estimated daily dosage and OXTR polymorphisms in male participants. We found that >21 IU per day oxytocin was more effective than ⩽21 IU per day, and that a SNP in OXTR (rs6791619) predicted CGI-I scores for ⩽21 IU per day oxytocin treatment. No severe adverse events occurred. These results suggest that efficacy of long-term oxytocin administration in young men with high-functioning ASD depends on the oxytocin dosage and genetic background of the oxytocin receptor, which contributes to the effectiveness of oxytocin treatment of ASD. PMID:27552585

  11. EVALUATION OF THE THERAPEUTIC EFFICACY OF HIGH-INTENSITY PULSED-PERIODIC LASER RADIATION (CLINICAL AND EXPERIMENTAL OBSERVATIONS)

    OpenAIRE

    2016-01-01

    From the experience of clinical observations, we have shown a high therapeutic effectiveness of the medical laser KULON-MED in: cosmetics, non-cancer inflammatory diseases of the gastrointestinal tract and cancer (cancer of the stomach and colon) as at different wavelengths, and with different types of photosensitizers. In the area of anti-tumor photodynamic therapy (PDT), based on experimental studies, we have showed the high antitumor (sarcoma S‑37) effectiveness of the laser (with the inhi...

  12. Effects of high-fidelity patient simulation led clinical reasoning course: Focused on nursing core competencies, problem solving, and academic self-efficacy.

    Science.gov (United States)

    Lee, JuHee; Lee, Yoonju; Lee, Senah; Bae, Juyeon

    2016-01-01

    To examine the effects of high-fidelity patient simulation (HFPS) led clinical reasoning course among undergraduate nursing students. A quasi-experimental study of non-equivalent control group pretest-post test design was applied. A total of 49 senior nursing students participated in this study. The experimental group consisted of the students who took the "clinical reasoning" course (n = 23) while the control group consisted of students who did not (n = 26). Self-administered scales including the nursing core competencies, problem solving, academic self-efficacy, and Kolb learning style inventory were analyzed quantitatively using SPSS version 20.0. Data analysis was conducted using one-way ancova due to a significant difference in nursing core competencies between the experimental group and control group. There was a significant improvement in nursing core competencies in the experimental group (F = 7.747, P = 0.008). The scores of problem solving and academic self-efficacy were higher in the experimental group after the HFPS led clinical reasoning course without statistical difference. There is a need for the development of effective instructional methods to improve learning outcomes in nursing education. Future research is needed related to simulation education as well as management strategies so that learning outcomes can be achieved within different students' learning style. © 2015 The Authors. Japan Journal of Nursing Science © 2015 Japan Academy of Nursing Science.

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

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    Pilar Teixidor

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

  14. Efficacy of High-volume Evacuator in Aerosol Reduction: Truth or Myth? A Clinical and Microbiological Study

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    Hitesh Desarda

    2014-09-01

    Full Text Available Background and aims. Basic periodontal treatment aims at eliminating supra- and sub-gingival plaque and establishing conditions which will allow effective self-performed plaque control. This aim is primarily achieved with sonic and ultrasonic scalers. However, generation of bacterial aerosols during these procedures is of great concern to patients, the dentist and the dental assistant. The aim of this study was to compare the reduction in aerosol with and without high-volume evacuator through a microbiological study. Materials and methods. For this clinical study a fumigated closed operatory was selected. Maxillary incisors and canines were selected as an area for scaling. Piezoelectric ultrasonic scaling was performed in the absence and in the presence of a high-volume evacuator at 12 and 20 inches from the patient's oral cavity. In both groups scaling was carried out for 10 minutes. Nutrient agar plates were exposed for a total of 20 minutes. After this procedure, nutrient agar plates were incubated in an incubator at 37°C for 24 hours. The next day the nutrient agar plates were examined for colony forming units by a single microbiologist. Results. The results showed no statistically significant differences in colony forming units (CFU with and without the use of a high-volume evacuator either at 12 or 20 inches from the patient’s oral cavity. Conclusion. It was concluded that high-volume evacuator, when used as a separate unit without any modification, is not effective in reducing aerosol counts and environmental contamination.

  15. [Comparison of clinical efficacy between decitabine combined with CAG regimen and CAG regimen alone in patients with intermediate to high-risk myelodysplastic syndromes].

    Science.gov (United States)

    Zhang, Yun-Ping; Wu, Wen-Zhong; Cui, Guo-Xing

    2014-10-01

    This study was purposed to compare the clinical efficacy and adverse reactions of low-dose decitabine combined with CAG regimen (aclarubicin, Ara-C, and G-CSF) and CAG regimen alone in intermediate to high-risk myelodysplastic syndromes (MDS), and evaluate the validity and efficacy of the former regimen as new treatment method of intermediate to high-risk myelodysplastic syndromes. A total of 12 patients with intermediate (IR) to high-risk (HR) MDS treated by low-dose decitabine combined with CAG regimen and 10 patients with IR to HR MDS treated by CAG regimen alone were evaluated after treatment of 1 cycle and at least after 2 cycles. The complete remission (CR) after 1 cycle, overall remission rate (ORR), progression free survival (PFS) and overall survival (OS) between them were analyzed. The results showed that 9 patients treated by low-dose decitabine combined with CAG regimen achieved complete remission after 1 cycle, 2 patients achieved partial remission, 1 patient did not show reaction. The complete remission rate was 75.0% and overall response rate was 91.7%. The median time of disease free survival was 9 months (0-27 months). The median overall survival time was 16 months (3-28 months). 4 patients suffered from pulmonary infection after treatment and then were all cured after treatment with anti-infective therapy. The 5 patients treated by CAG regimen alone achieved complete remission,3 patients achieved partial remission, 2 patients showed non-reaction. The complete remission rate was 50.0% and overall response rate was 80.0%. The median time of disease free survival was 6 months(0-18 months). The median overall survival time was 13 months(3-31 months), 4 patients suffered from pulmonary infection, 1 patient suffered from enteric infection and 1 patient suffered from Escherichia coli septicemia after treatment, all of them becomed better after active treatment. Two groups of patients all had no serious adverse reactions, All patients could tolerate, no

  16. Treatment of hyperlipoidemia by Xiaozhi capsule: a clinical efficacy research

    Institute of Scientific and Technical Information of China (English)

    王建平

    2013-01-01

    Objective To observe the clinical effect and efficacy of Xiaozhi Capsule (XZC) ,a Chinese medicine preparation for tonifying Gan-Shen,invigorating Pi to dissipate dampness (TGSIPDD) on total cholesterol (TC) ,triglyceride (TG) ,high-density lipoprotein cholesterol (HDLC) ,low-density lipoprotein cholesterol (LDL-C) ,and

  17. Preclinical pharmacology, efficacy, and safety of varenicline in smoking cessation and clinical utility in high risk patients

    Directory of Open Access Journals (Sweden)

    Zheng-Xiong Xi

    2010-04-01

    Full Text Available Zheng-Xiong XiNational Institute on Drug Abuse, Intramural Research Program, Baltimore, MD, USAAbstract: Smoking is still the most prominent cause of preventable premature death in the United States and an increasing cause of morbidity and mortality throughout the world. Although the current treatments such as nicotine replacement therapy (NRT and bupropion are effective, long-term abstinence rates are low. Mechanism studies suggest that the pleasurable effects of smoking are mediated predominantly by nicotine, which activates the brain reward system by activation of brain α4β2 nicotinic acetylcholine receptors (nAChRs. Varenicline is a novel α4β2 nAChR partial agonist and has been found to be even more effective than NRT or bupropion in attenuating smoking satisfaction and in relieving craving and withdrawal symptoms after abstinence. Thus, varenicline has been recently approved to be a first-line medication for smoking cessation in the United States and European countries. Varenicline is generally well tolerated in healthy adult smokers, with the most commonly reported adverse effects being nausea, insomnia, and headache. However, growing postmarketing data has linked varenicline to an increase in neuropsychiatric symptoms such as seizures, suicidal attempts, depression, and psychosis as well as serious injuries potentially relating to unconsciousness, dizziness, visual disturbances, or movement disorders. Therefore, new safety warnings are issued to certain high risk populations, such as patients with mental illness and operators of commercial vehicles and heavy machinery. In particular, pilots, air traffic controllers, truck and bus drivers have been banned from taking varenicline.Keywords: nicotine, varenicline, α4β2 nicotinic acetylcholine receptor, nAChRs, partial agonist, smoking cessation

  18. Effectiveness of Harpagophytum extracts and clinical efficacy.

    Science.gov (United States)

    Chrubasik, Sigrun; Conradt, Christian; Roufogalis, Basil D

    2004-02-01

    Various preparations from Harpagophytum procumbens are used for the treatment of pain in the joints and lower back. Studies published in peer reviewed journals were examined for their clinical evidence. The studies offering preparations with 50-60 mg harpagoside in the daily dosage are of better quality and provide more reliable evidence on efficacy than a proprietary ethanol extract with half the amount of harpagoside per day. However, confirmatory studies are required for all extracts before they can gain a place in treatment guidelines.

  19. Chronic obstructive pulmonary disease treated with inhaled medium- or high-dose corticosteroids: a prospective and randomized study focusing on clinical efficacy and the risk of pneumonia

    Directory of Open Access Journals (Sweden)

    Cheng SL

    2014-05-01

    Full Text Available Shih-Lung Cheng,1,2 Kang-Cheng Su,3 Hao-Chien Wang,4,* Diahn-Warng Perng,3,* Pan-Chyr Yang4 1Department of Internal Medicine, Far Eastern Memorial Hospital, New Taipei City, 2Department of Chemical Engineering and Materials Science, Yuan Ze University, Zhongli City, Taoyuan County, 3Department of Chest Medicine, Taipei Veterans General Hospital, Taipei, 4Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan *These authors contributed equally to this work Purpose: Complications of pneumonia development in patients with chronic obstructive pulmonary disease (COPD receiving inhaled corticosteroid (ICS therapy have been documented. The aim of this study was to focus on clinical efficacy and the incidence of pneumonia between COPD patients receiving medium and high doses of ICS. Patients and methods: This prospective, randomized study included COPD patients identified from three tertiary medical centers from 2010 to 2012. The patients were randomized into two groups: high dose (HD; fluticasone 1,000 µg + salmeterol 100 µg/day and medium dose (MD; fluticasone 500 µg + salmeterol 100 µg/day. Lung function with forced expiratory volume in 1 second (FEV1, forced vital capacity, and COPD-assessment test (CAT were checked every 2 months. The frequency of acute exacerbations and number of pneumonia events were measured. The duration of the study period was 1 year. Results: In total, 237 COPD patients were randomized into the two treatment arms (115 in the HD group, 122 in the MD group. The FEV1 level was significantly improved in the patients in the HD group compared with those in the MD group (HD 103.9±26.6 mL versus MD 51.4±19.7 mL, P<0.01 at the end of the study. CAT scores were markedly improved in patients using an HD compared to those using an MD (HD 13±5 versus MD 16±7, P=0.05. There was a significant difference in the percentage of annual rates in acute exacerbations (HD 0.16 versus MD 0.34, P<0.01 between the

  20. Comparison of therapeutic efficacy and clinical parameters between recombinant human thyroid stimulating hormone and thyroid hormone withdrawal in high-dose radioiodine treatment with differentiated thyroid cancer

    Energy Technology Data Exchange (ETDEWEB)

    Choi, Se Hun; Na, Chang Ju; Kim, Jeong Hun; Han, Yeon Hee; KIm, Hee Kwon; Jeong, Hwan Jeong; Sohn, Myung Hee; Lim, Seok Tae [Dept. of Nuclear Medicine, Chonbuk National University Medical School and Hospital, Jeonju (Korea, Republic of)

    2015-06-15

    High-dose radioiodine treatment (HD-RIT) after injection of recombinant human thyroid stimulating hormone (rh-TSH) has become widely used. This study compared the therapeutic efficacy of HD-RIT and clinical parameters between rh-TSH supplement and thyroid hormone withdrawal (THW) after total thyroidectomy in patients with differentiated thyroid cancer. We retrospectively reviewed 266 patients (47 male and 219 female; age, 49.0 ± 10.9 years) with differentiated thyroid cancer detected from September 2011 to September 2012. Patients comprised THW (217, 81.6 %) and rh-TSH (49, 18.4 %). Inclusion criteria were: first HD-RIT; any TN stage; absence of distant metastasis. To evaluate the complete ablation of the remnant thyroid tissue or metastasis, we reviewed stimulated serum thyroglobulin (sTg), I-123 whole-body scan (RxWBS) on T4 off-state, and thyroid ultrasonography (US) or [F-18]-fluorodeoxyglucose positron emission tomography/computed tomography (F-18 FDG PET/CT) 6–8 months after HD-RIT. We defined a complete ablation state when all three of the follow-up conditions were satisfied; <2.0 ng/ml of the sTg, I-123 RxWBS (−), and thyroid US or F-18 FDG PET/CT (−). If one of the three was positive, ablation was considered incomplete. We also compared various clinical biomarkers (body weight, body mass index, liver and kidney function) between THW and rh-TSH groups. The rates of complete ablation were 73.7 % (160/217) for the THW group and 73.5 % (36/49) for the rh-TSH group. There was no significant difference between the two groups (p = 0.970). The follow-up aspartate transaminase (p = 0.001) and alanine transaminase (p = 0.001) were significantly higher in the THW group. The renal function parameters of blood urea nitrogen (p = 0.001) and creatinine (p = 0.005) tended to increase in the THW group. The change of body weight was + Δ0.96 (±1.9) kg for the THW group and was decreased by -Δ1.39 (±1.5) kg for the rh-TSH group. The change

  1. Efficacy of clinical gait analysis: A systematic review.

    Science.gov (United States)

    Wren, Tishya A L; Gorton, George E; Ounpuu, Sylvia; Tucker, Carole A

    2011-06-01

    The aim of this systematic review was to evaluate and summarize the current evidence base related to the clinical efficacy of gait analysis. A literature review was conducted to identify references related to human gait analysis published between January 2000 and September 2009 plus relevant older references. The references were assessed independently by four reviewers using a hierarchical model of efficacy adapted for gait analysis, and final scores were agreed upon by at least three of the four reviewers. 1528 references were identified relating to human instrumented gait analysis. Of these, 116 original articles addressed technical accuracy efficacy, 89 addressed diagnostic accuracy efficacy, 11 addressed diagnostic thinking and treatment efficacy, seven addressed patient outcomes efficacy, and one addressed societal efficacy, with some of the articles addressing multiple levels of efficacy. This body of literature provides strong evidence for the technical, diagnostic accuracy, diagnostic thinking and treatment efficacy of gait analysis. The existing evidence also indicates efficacy at the higher levels of patient outcomes and societal cost-effectiveness, but this evidence is more sparse and does not include any randomized controlled trials. Thus, the current evidence supports the clinical efficacy of gait analysis, particularly at the lower levels of efficacy, but additional research is needed to strengthen the evidence base at the higher levels of efficacy.

  2. Identification and Pharmacological Analysis of High Efficacy Small Molecule Inhibitors of EGF-EGFR Interactions in Clinical Treatment of Non-Small Cell Lung Carcinoma: a Computational Approach.

    Science.gov (United States)

    Gudala, Suresh; Khan, Uzma; Kanungo, Niteesh; Bandaru, Srinivas; Hussain, Tajamul; Parihar, Ms; Nayarisseri, Anuraj; Mundluru, Hema Prasad

    2015-01-01

    Inhibition of EGFR-EGF interactions forms an important therapeutic rationale in treatment of non-small cell lung carcinoma. Established inhibitors have been successful in reducing proliferative processes observed in NSCLC, however patients suffer serious side effects. Considering the narrow therapeutic window of present EGFR inhibitors, the present study centred on identifying high efficacy EGFR inhibitors through structure based virtual screening strategies. Established inhibitors - Afatinib, Dacomitinib, Erlotinib, Lapatinib, Rociletinib formed parent compounds to retrieve similar compounds by linear fingerprint based tanimoto search with a threshold of 90%. The compounds (parents and respective similars) were docked at the EGF binding cleft of EGFR. Patch dock supervised protein-protein interactions were established between EGF and ligand (query and similar) bound and free states of EGFR. Compounds ADS103317, AKOS024836912, AGN-PC-0MXVWT, GNF-Pf-3539, SCHEMBL15205939 were retrieved respectively similar to Afatinib, Dacomitinib, Erlotinib, Lapatinib, Rociletinib. Compound- AGN-PC-0MXVWT akin to Erlotinib showed highest affinity against EGFR amongst all the compounds (parent and similar) assessed in the study. Further, AGN-PC-0MXVWT brought about significant blocking of EGFR-EGF interactions in addition showed appreciable ADMET properties and pharmacophoric features. In the study, we report AGN-PC-0MXVWT to be an efficient and high efficacy inhibitor of EGFR-EGF interactions identified through computational approaches.

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

    African Journals Online (AJOL)

    Purpose: To assess the clinical efficacy and side effects of radiotherapy combined with sodium glycididazole in ... effect in the treatment of recurrent oesophageal carcinoma than radiotherapy alone. Keywords: ..... Chen J, Zhou ZR. Research ...

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

    African Journals Online (AJOL)

    A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety and Cost Effectiveness of ... Log in or Register to get access to full text downloads. ... Pharmacological control of pain is the mainstay of management of osteoarthritis.

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

    Science.gov (United States)

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

    2016-10-01

    The aim of this study was to compare the therapeutic efficacy of high-power pain threshold (HPPT) ultrasound therapy applied to the trigger points and dry needling (DN) in myofascial pain syndrome. Sixty-one patients were randomly assigned to an HPPT (n = 30) and dry needling (n = 31) groups. The primary outcome measures were the Visual Analog Scale (VAS) and Neck Pain and Disability Scale (NPDS), both at 1 week and 4 weeks after treatment. The secondary outcome measures were the number of painful trigger points, range of the tragus-acromioclavicular joint, the Short Form-36, the Beck Depression Inventory, the Beck Anxiety Inventory, and sonoelastographic tests after a 1-week treatment. More improvement was seen in anxiety in the HPPT group (P 0.05). A decrease in tissue stiffness was only seen in the HPPT group (P myofascial pain syndrome. Although a significant decrease was shown in tissue stiffness with HPPT, neither of these treatments had an apparent superiority.

  6. Two-week extrinsic stain removal efficacy of a sodium fluoride dentifrice with high cleaning silica: results from two randomized, controlled clinical trials.

    Science.gov (United States)

    Ni, LongXing; Li, Jie; He, Tao; Chang, JinLan; Sun, Lily

    2012-08-01

    To evaluate a stannous-containing sodium fluoride dentifrice with high cleaning silica and polychelation technology (test dentifrice) compared to a currently marketed whitening dentifrice, which carries the ADA Seal of Acceptance for whitening, for its efficacy in removing existing natural stain over a 2-week period. Two independent, randomized, positive-controlled, 2-treatment, parallel group, double-blind, 2-week studies with identical protocols were conducted in China. At baseline, subjects received an oral soft tissue (OST) examination followed by a Lobene stain examination. In each study, approximately 60 subjects having a Lobene stain composite score above 1 were randomized to one of two dentifrice products: the test dentifrice or the positive control. Subjects were instructed to brush twice daily for at least 1 minute with their assigned product. Lobene stain and OST examinations were conducted again after 2 weeks of use. In both studies, the test dentifrice and the positive control dentifrice demonstrated statistically significant reductions in Lobene composite (P0.12).

  7. Application of self-efficacy theory in dental clinical practice.

    Science.gov (United States)

    Kakudate, N; Morita, M; Fukuhara, S; Sugai, M; Nagayama, M; Kawanami, M; Chiba, I

    2010-11-01

    In clinical practice, self-efficacy refers to how certain a patient feels about his or her ability to take the necessary action to improve the indicators and maintenance of health. It is assumed that the prognosis for patient behaviour can be improved by assessing the proficiency of their self-efficacy through providing psychoeducational instructions adapted for individual patients, and promoting behavioural change for self-care. Therefore, accurate assessment of self-efficacy is an important key in daily clinical preventive care. The previous research showed that the self-efficacy scale scores predicted patient behaviour in periodontal patients and mother's behaviour in paediatric dental practice. Self-efficacy belief is constructed from four principal sources of information: enactive mastery experience, vicarious experience, verbal persuasion, and physiological and affective states. Thus, self-efficacy can be enhanced by the intervention exploiting these sources. The previous studies revealed that behavioural interventions to enhance self-efficacy improved oral-care behaviour of patients. Therefore, assessment and enhancement of oral-care specific self-efficacy is important to promote behaviour modification in clinical dental practice. However, more researches are needed to evaluate the suitability of the intervention method.

  8. Safety profile, efficacy, and biodistribution of a bicistronic high-capacity adenovirus vector encoding a combined immunostimulation and cytotoxic gene therapy as a prelude to a phase I clinical trial for glioblastoma

    Energy Technology Data Exchange (ETDEWEB)

    Puntel, Mariana [Department of Neurosurgery, The University of Michigan School of Medicine, MSRB II, RM 4570C, 1150 West Medical Center Drive, Ann Arbor, MI 48109-5689 (United States); Department of Cell and Developmental Biology, The University of Michigan School of Medicine, MSRB II, RM 4570C, 1150 West Medical Center Drive, Ann Arbor, MI 48109-5689 (United States); Gene Therapeutics Research Institute, Cedars-Sinai Medical Center, Los Angeles, CA 90048 (United States); Ghulam, Muhammad A.K.M. [Gene Therapeutics Research Institute, Cedars-Sinai Medical Center, Los Angeles, CA 90048 (United States); Farrokhi, Catherine [Department of Psychiatry and Behavioral Neurosciences, Cedars Sinai Medical Center, Los Angeles, CA 90048 (United States); VanderVeen, Nathan; Paran, Christopher; Appelhans, Ashley [Department of Neurosurgery, The University of Michigan School of Medicine, MSRB II, RM 4570C, 1150 West Medical Center Drive, Ann Arbor, MI 48109-5689 (United States); Department of Cell and Developmental Biology, The University of Michigan School of Medicine, MSRB II, RM 4570C, 1150 West Medical Center Drive, Ann Arbor, MI 48109-5689 (United States); Kroeger, Kurt M.; Salem, Alireza [Gene Therapeutics Research Institute, Cedars-Sinai Medical Center, Los Angeles, CA 90048 (United States); Lacayo, Liliana [Department of Psychiatry and Behavioral Neurosciences, Cedars Sinai Medical Center, Los Angeles, CA 90048 (United States); Pechnick, Robert N. [Department of Psychiatry and Behavioral Neurosciences, Cedars Sinai Medical Center, Los Angeles, CA 90048 (United States); Department of Psychiatry and Behavioral Neurosciences, David Geffen School of Medicine, University of California, Los Angeles, CA (United States); Kelson, Kyle R.; Kaur, Sukhpreet; Kennedy, Sean [Gene Therapeutics Research Institute, Cedars-Sinai Medical Center, Los Angeles, CA 90048 (United States); Palmer, Donna; Ng, Philip [Department of Molecular and Human Genetics, Baylor College of Medicine, Houston, TX 77030 (United States); and others

    2013-05-01

    Adenoviral vectors (Ads) are promising gene delivery vehicles due to their high transduction efficiency; however, their clinical usefulness has been hampered by their immunogenicity and the presence of anti-Ad immunity in humans. We reported the efficacy of a gene therapy approach for glioma consisting of intratumoral injection of Ads encoding conditionally cytotoxic herpes simplex type 1 thymidine kinase (Ad-TK) and the immunostimulatory cytokine fms-like tyrosine kinase ligand 3 (Ad-Flt3L). Herein, we report the biodistribution, efficacy, and neurological and systemic effects of a bicistronic high-capacity Ad, i.e., HC-Ad-TK/TetOn-Flt3L. HC-Ads elicit sustained transgene expression, even in the presence of anti-Ad immunity, and can encode large therapeutic cassettes, including regulatory elements to enable turning gene expression “on” or “off” according to clinical need. The inclusion of two therapeutic transgenes within a single vector enables a reduction of the total vector load without adversely impacting efficacy. Because clinically the vectors will be delivered into the surgical cavity, normal regions of the brain parenchyma are likely to be transduced. Thus, we assessed any potential toxicities elicited by escalating doses of HC-Ad-TK/TetOn-Flt3L (1 × 10{sup 8}, 1 × 10{sup 9}, or 1 × 10{sup 10} viral particles [vp]) delivered into the rat brain parenchyma. We assessed neuropathology, biodistribution, transgene expression, systemic toxicity, and behavioral impact at acute and chronic time points. The results indicate that doses up to 1 × 10{sup 9} vp of HC-Ad-TK/TetOn-Flt3L can be safely delivered into the normal rat brain and underpin further developments for its implementation in a phase I clinical trial for glioma. - Highlights: ► High capacity Ad vectors elicit sustained therapeutic gene expression in the brain. ► HC-Ad-TK/TetOn-Flt3L encodes two therapeutic genes and a transcriptional switch. ► We performed a dose escalation study at

  9. [Pulmonary rehabilitation: pathophysiology, indications, and clinical efficacy].

    Science.gov (United States)

    Riario Sforza, G G; Incorvaia, C

    2010-01-01

    Pulmonary rehabilitation (PR) is a non pharmacologic treatment of demonstrated efficacy indicated for symptomatic patients with chronic lung diseases. In the pulmonary rehabilitation programs (PRPs), exercise training is a cornerstone component, recommended for improving muscle function. Its aim is to address the disability, intended as the reduction in functional performance and quality of life, derived from muscle deconditioning caused by physical inactivity due to chronic breathlessness, fatigue, and impairment of daily activities claimed by patients with chronic pulmonary diseases. Other components of PRPs are educational, psychosocial and nutritional interventions. Moreover, any PRP should include an outcome assessment, needed for an objective evaluation of program effectiveness, and of patient progress through the time. Although its pivotal role is now accepted worldwide, this was not the prevailing thought during the 1980's and the 1990's, when the pathophysiologic rationale of PR was still not demonstrated, condemning it to be an ancillary treatment to add to standard COPD treatment. The following ascent of PR was mainly due to the number of studies providing its effectiveness, overcoming skepticism and convincing physicians and institutions about its efficacy. Today PR clearly improves exercise tolerance, dyspnea, and quality of life, but despite such demonstration, it is mostly overlooked by health professionals, and only about 2% of patients with COPD undergo to PRPs. A proper consideration of the capability of PR is warranted to ensure optimal management of COPD when the disease causes symptoms and a decrease in physical capacity.

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

    Science.gov (United States)

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

    2006-09-01

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

  11. Efficacy and safety of linagliptin in type 2 diabetes subjects at high risk for renal and cardiovascular disease: a pooled analysis of six phase III clinical trials.

    Science.gov (United States)

    von Eynatten, Maximilian; Gong, Yan; Emser, Angela; Woerle, Hans-Juergen

    2013-04-09

    In patients with type 2 diabetes mellitus (T2DM), hypertension and microalbuminuria are predictive markers for increased renal and cardiovascular risk. This post hoc analysis of data from a global development program aimed to evaluate the efficacy and safety of linagliptin in a population with joint prevalence of these two vascular risk factors. Data for patients with baseline microalbuminuria (urine albumin-to-creatinine ratio 30-300 mg/g) and hypertension (systolic blood pressure ≥ 140 mm Hg and/or diastolic blood pressure ≥ 90 mm Hg and/or a history of hypertension; and/or an antihypertensive treatment at baseline) who participated in any of six randomized, placebo-controlled, phase III trials were analyzed. Participants received linagliptin 5 mg daily (alone or in combination with other oral antidiabetic drugs) or placebo for 18 to 24 weeks. Of 3,119 patients, 512 had both microalbuminuria and hypertension (linagliptin, 366; placebo, 146). Baseline mean (SD) HbA1c was 8.3 (0.9)% and 8.4 (0.9)%; median (range) urine albumin-to-creatinine ratio was 60 (30-292) mg/g and 64 (30-298) mg/g; mean (SD) systolic blood pressure was 138 (15) mm Hg and 135 (16) mm Hg; and mean (SD) diastolic blood pressure was 81 (10) mm Hg and 81 (10) mm Hg, for linagliptin and placebo, respectively. Placebo-corrected mean change in HbA1c from baseline to week 18 and week 24 was -0.57% (95% CI: -0.75, -0.39; P blood pressure, cholesterol and triglyceride levels were similar between linagliptin and placebo. In T2DM patients with the two common vascular risk factors of hypertension and microalbuminuria, linagliptin achieved significant improvements in glycemic control. In this vulnerable patient population at high risk for micro- and macrovascular complications, linagliptin was well tolerated.

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

    Directory of Open Access Journals (Sweden)

    Shahla Mohamadirizi

    2015-12-01

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

  13. Lipid formulations of amphotericin B: clinical efficacy and toxicities.

    Science.gov (United States)

    Wong-Beringer, A; Jacobs, R A; Guglielmo, B J

    1998-09-01

    Commercially available lipid formulations of amphotericin B (Abelcet, Amphotec, and AmBisome) represent a significant advance in drug delivery technology. Differences in biochemical, pharmacokinetic, and pharmacodynamic properties among the lipid products have been shown in in vitro and in vivo models. Clinical experience with these products has been primarily in patients either refractory to or intolerant of conventional amphotericin B deoxycholate (AmBd). None of the lipid-based products demonstrates superior efficacy when prospectively compared with AmBd in the treatment of documented infections. When used for the empirical treatment of febrile neutropenia, AmBisome significantly reduced the incidence of proven emergent fungal infections but did not improve short-term survival rates, in comparison with AmBd. Acute infusion-related adverse events vary, whereas nephrotoxicity is reduced with all three lipid formulations. Until superior efficacy is clearly shown (for documented infections) or pharmacoeconomic analyses document the value of these drugs, use of such expensive agents should be highly restricted to those who are intolerant of or refractory to AmBd.

  14. Clinical Efficacy of Psychoeducational Interventions with Family Caregivers

    Science.gov (United States)

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

    2016-01-01

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

  15. World Antimalarial Resistance Network I: Clinical efficacy of antimalarial drugs

    Directory of Open Access Journals (Sweden)

    Olliaro Piero

    2007-09-01

    Full Text Available Abstract The proliferation of antimalarial drug trials in the last ten years provides the opportunity to launch a concerted global surveillance effort to monitor antimalarial drug efficacy. The diversity of clinical study designs and analytical methods undermines the current ability to achieve this. The proposed World Antimalarial Resistance Network (WARN aims to establish a comprehensive clinical database from which standardised estimates of antimalarial efficacy can be derived and monitored over time from diverse geographical and endemic regions. The emphasis of this initiative is on five key variables which define the therapeutic response. Ensuring that these data are collected at the individual patient level in a consistent format will facilitate better data management and analytical practices, and ensure that clinical data can be readily collated and made amenable for pooled analyses. Such an approach, if widely adopted will permit accurate and timely recognition of trends in drug efficacy. This will guide not only appropriate interventions to deal with established multidrug resistant strains of malaria, but also facilitate prompt action when new strains of drug resistant plasmodia first emerge. A comprehensive global database incorporating the key determinants of the clinical response with in vitro, molecular and pharmacokinetic parameters will bring together relevant data on host, drug and parasite factors that are fundamental contributors to treatment efficacy. This resource will help guide rational drug policies that optimize antimalarial drug use, in the hope that the emergence and spread of resistance to new drugs can be, if not prevented, at least delayed.

  16. Clinical efficacy of cyclophosphamide in treatment of primary sclerosing cholangitis

    Institute of Scientific and Technical Information of China (English)

    程鹏

    2014-01-01

    Objective To investigate the clinical efficacy of cy-clophosphamide in the treatment of primary sclerosing cholangitis(PSC).Methods Twenty-four patients with PSC who received treatment in the department of gastroenterology in our hospital from January 2004 to December2012 were selected as subjects and divided into observation group(n=13)and control

  17. Clinical efficacy of endoscopic high-frequency electrocoagulation combined with PPI in treatment of short-segment Barrett's esophagus%内镜下高频电凝加PPI治疗短段Barrett食管的临床研究

    Institute of Scientific and Technical Information of China (English)

    何远琴; 侯俊; 李静娴; 赖敏莉

    2014-01-01

    目的:探讨内镜下高频电凝加PPI治疗短段Barrett食管(SSBE)疗效及安全性。方法经内镜及病理检查确诊的60例舌型及岛型SSBE患者分为两组,治疗组30例行内镜下高频电凝加口服雷贝拉唑20 mg,2次/日,维持抑酸治疗4周;对照组30例单纯给予口服雷贝拉唑20 mg,2次/日,治疗4周,后减量至20 mg,1次/日,维持治疗1年;分别于治疗后3、6、12、18及24个月复查胃镜并取活组织送病理检查。治疗组中复查胃镜未达显效的患者,再次行内镜下高频电凝治疗并予口服PPI治疗4周。结果治疗组平均显效率为87.0%,总有效率为100%,与对照组(8.1%,27.8%)相比,差异有统计学意义(P<均0.01);治疗组未出现出血、穿孔及食管狭窄等并发症。结论内镜下高频电凝加PPI治疗SSBE疗效明显,安全,并发症少。%Objective To study the clinical efficacy of endoscopic high-frequency electrocoagulation combined with proton pump inhibitor (PPI)in the treatment of tongue-and island-type SSBE. Methods Sixty patients pathologically diagnosed with tongue-and island-type SSBE were divided into the treatment (n=30 ) and control groups (n =30 ). In the treatment group,patients were treated with endoscopic high-frequency electrocoagulation combined with 20 mg of rabeprazole twice daily for 4 consecutive weeks,while the counter-parts in the control group were treated with 20 mg of rabeprazole twice daily for 4 consecutive weeks,and the dose was reduced to 20 mg of rabeprazole once daily and the maintenance therapy was delivered for 1 year. All patients underwent gastroscopy and biopsy samples were collected for pathological examination at 3,6,12,18 and 24 months after treatment beginning. The patients in the treatment group achieved no significant efficacy repeatedly received endoscopic high-frequency electrocoagulation and rabeprazole administration for another 4 weeks

  18. Clinical trial: a novel high-dose 1 g mesalamine suppository (Salofalk) once daily is as efficacious as a 500-mg suppository thrice daily in active ulcerative proctitis.

    Science.gov (United States)

    Andus, Tilo; Kocjan, Andreas; Müser, Moritz; Baranovsky, Andrey; Mikhailova, Tatyana L; Zvyagintseva, Tatyana D; Dorofeyev, Andrey E; Lozynskyy, Yurii S; Cascorbi, Ingolf; Stolte, Manfred; Vieth, Michael; Dilger, Karin; Mohrbacher, Ralf; Greinwald, Roland

    2010-11-01

    Mesalamine suppositories are first-line therapy in active ulcerative proctitis; the standard regime still recommends multiple doses per day. The primary objective of this study was to show the noninferiority of once-daily administration of a novel 1 g mesalamine suppository versus thrice-daily administration of the 0.5 g mesalamine suppository. This was a single-blind (investigator-blinded), randomized, multicenter, comparative, Phase III clinical trial. Patients with mild to moderately active ulcerative proctitis inserted either one mesalamine 1 g suppository at bedtime or one mesalamine 0.5 g suppository thrice daily over a 6-week period. The primary endpoint was rate of remission (Disease Activity Index below 4). In all, 354 patients were evaluable for safety and per-protocol analysis. The new regimen demonstrated noninferiority: The percentage of patients with remission was 87.9% for the once-daily 1 g mesalamine suppository and 90.7% for the thrice-daily 0.5 g mesalamine suppository. Each regimen resulted in prompt cessation of clinical symptoms (e.g., median time to ≤3 stools per day (all without blood): 5 days in the 1 g mesalamine once-daily and 7 days in the 0.5 g mesalamine thrice-daily group). Patients preferred applying suppositories once a day. In active ulcerative proctitis the once-daily administration of a 1 g mesalamine suppository is as effective and safe, yet considerably more convenient, than the standard thrice-daily administration of a 0.5 g mesalamine suppository.

  19. [Clinical efficacy of decitabine plus improved CAG chemotherapy and haplo-identical donor peripheral lymphocyte infusion regimen on elderly patients with high risk myelodysplastic syndrome and acute myeloid leukemia].

    Science.gov (United States)

    Dou, Li-Ping; Jing, Yu; Wang, Quan-Shun; Mei, Jun-Hui; Yu, Li

    2013-06-01

    This study was aimed to observe the clinical efficacy and adverse effects of decitabine plus improved CAG chemotherapy and haploid-identical donor peripheral lymphocyte infusion regimen on elderly patients with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). Five elderly patients with MDS and AML were treated with decitabine plus improved CAG chemotherapy and donor peripheral lymphocyte infusion regimen. Examinations on liver and renal function, electrocardiogram and bone marrow analysis were performed before and after treatment, and adverse effects were observed. The results indicated that after a course of treatment by decitabine plus improved CAG chemotherapy and haplo-identical donor peripheral lymphocyte infusion regimen, the total effective rate was 100%, and 4 patients (80%) achieved complete remission, 1 patient achieved partial remission. The dominant clinical adverse effect was bone marrow depression, the median time of neutrophil>0.5×10(9)/L and platelet>20×10(9)/L was 15 d and 16 d respectively for patients without previous MDS. It is concluded that decitabine plus improved CAG chemotherapy and haploid-identical donor peripheral lymphocyte infusion regimen may be effective with less adverse effects for elderly primary AML and high risk MDS patients, it is a promising therapeutic methods and worthy to deeply study.

  20. Clinical Self-Efficacy in Senior Nursing Students: A Mixed- Methods Study

    OpenAIRE

    Abdal; Masoudi Alavi; Adib-Hajbaghery

    2015-01-01

    Background Clinical education has a basic role in nursing education, and effective clinical training establishes a sense of clinical self-efficacy in senior nursing students. Self-efficacy is a key component for acting independently in the nursing profession. Objectives This study was designed to outline senior nursing students’ views about clinical self-efficacy and to determine its level in nursing students. ...

  1. Suction blister grafting for vitiligo: efficacy and clinical predictive factors.

    Science.gov (United States)

    Gou, Darlene; Currimbhoy, Sharif; Pandya, Amit G

    2015-05-01

    Suction blister epidermal grafting (SBEG) is a well-established treatment modality for vitiligo, but predictive factors for outcomes are not well characterized. To determine the efficacy and predictive variables for response to SBEG in patients with vitiligo. A retrospective single-center review of all cases treated with SBEG was performed. Repigmentation was assessed by 2 independent reviewers by assessing pigment spread of grafts during the postoperative period. Repigmentation rates were then compared with patient demographics and transplant location. A total of 28 patients were enrolled in this study. The total number of grafts was 129, of which 86.8% (112/129) survived. Highest rate of graft survival was seen in patients younger than 20 years (100%) and the lowest in patients older than 40 years (75%-78%). Repigmentation was seen in 68% of patients. The highest degree of pigment spread was on the neck (283%) and face (231%), whereas the hands and feet had the least response (119%). Blister grafting is successful in most patients with vitiligo, with a high graft survival rate; however, the degree of pigment spread is variable and depends on clinical characteristics of the patient and graft site.

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

    OpenAIRE

    V. N. Chodyrev; N I Znaisheva; G M Lobanova; L M Ridnyak

    2003-01-01

    Objective. To assess alflutop clinical efficacy and safety during long-term course treatment of knee osteoarthritis. Methods. 51 pts with definite knee osteoarthritis of I-III stage according to Kellgren-Lawrence classification were included in an open controlled study. 20 pts received 6 intra-articular injections of alflutop 2 ml with subsequent intramuscular treatment during 3 months. Such courses were repeated 6 months apart for 2 years. 31 pts of control group received nonsteroidal anti-i...

  3. [Acupuncture clinical trials published in high impact factor journals].

    Science.gov (United States)

    Hu, Min; Liu, Jian-Ping; Wu, Xiao-Ke

    2014-12-01

    Acupuncture clinical trials are designed to provide reliable evidence of clinical efficacy, and SCI papers is one of the high-quality clinical efficacy of acupuncture research. To analyze these papers published in high impact factor journals on acupuncture clinical trials, we can study clinical trials from design to implementation, the efficacy of prevention and cure, combined with international standard practices to evaluate the effectiveness and safety of acupuncture. That is the core of acupuncture clinical trials, as well as a prerequisite for outstanding academic output. A scientific and complete acupuncture clinical trial should be topically novel, designed innovative, logically clear, linguistically refining, and the most important point lies in a great discovery and solving the pragmatic problem. All of these are critical points of papers to be published in high impact factor journal, and directly affect international evaluation and promotion of acupuncture.

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

    Directory of Open Access Journals (Sweden)

    V. N. Chodyrev

    2003-01-01

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

  5. Pentamycin shows high efficacy against Trichomonas vaginalis.

    Science.gov (United States)

    Kranzler, Markus; Syrowatka, Michael; Leitsch, David; Winnips, Cornelis; Walochnik, Julia

    2015-04-01

    Trichomonas vaginalis is the causative agent of the venereal disease trichomoniasis, which is the most frequent non-viral sexually transmitted disease worldwide. Since the 1960s, metronidazole has been the standard treatment, however an increasing number of cases with metronidazole-resistant strains is being reported. In this study, pentamycin, a polyene antibiotic, was tested for its in vitro efficacy against T. vaginalis using four strains with different metronidazole susceptibilities. It was shown that pentamycin is highly active against T. vaginalis and that the effect is prompt and independent of underlying metronidazole resistance. The effective concentrations (EC values) after 1 h of treatment were in the range 1.74-2.62 μg/mL (EC50) and 4.91-6.51 μg/mL (EC90). Total eradication of trichomonads (EC100) was achieved in all strains by treatment with 15 μg/mL (22 μM) for 1 h or with ≥1 μg/mL (≥1.5 μM) for 24 h. Long-term cultivation (12 months) under permanent drug pressure did not induce stable resistance against pentamycin in any of the strains tested. Pentamycin has been approved for intravaginal use and is a promising candidate for the topical treatment of trichomoniasis.

  6. Clinical pearls: factors affecting reported contraceptive efficacy rates in clinical studies.

    Science.gov (United States)

    Burkman, Ronald T

    2002-01-01

    Current combination oral contraceptives (OCs) are among the most popular, safe, and effective methods of reversible contraception. There are, however, many factors that can affect contraceptive failure rates as reported in clinical trials, including subject characteristics, factors related to study methodology and data analysis, and publication biases. The variability of these factors among clinical trials makes meaningful comparisons of contraceptive efficacy data across studies difficult, if not misleading or erroneous. It is even more difficult to reconcile the differences between clinical trial efficacy rates and everyday use rates; for instance, the National Survey of Family Growth reported that the rate of OC failure is close to 8% in the United States, which is higher than rates reported in clinical trials. Thus, it is important for the clinician to consider the many factors that can influence reporting of contraceptive failure rates in clinical trials and be aware of the limitations in differentiating OCs on the basis of contraceptive efficacy derived from clinical trial data. Furthermore, clinical trial data may not accurately predict contraceptive efficacy in everyday use.

  7. The effect of clinical nursing instructors on student self-efficacy.

    Science.gov (United States)

    Rowbotham, Melodie; Owen, Rachel M

    2015-11-01

    Clinical practicum experiences for nursing students provides the students an opportunity to apply concepts learned in class, practice skills learned in lab, and interact with patients, families, and other nurses. Although students look forward to these experiences, they often feel intimated and anxious about them. Clinical instructors play an important role in this experience and can either help or hinder student learning and self-efficacy. Using Bandura's Social Learning Theory as foundation, this descriptive study examined the relationship between perceived instructor effectiveness and student self-efficacy. Data were collected from a BSN school of nursing at a Midwestern USA comprehensive masters university. The instruments used were the Nursing Clinical Teacher Effectiveness Inventory (NCTEI) and the student self-efficacy (SSE) questionnaire. Participants (n = 236) were from a traditional nursing program with 86% female and 14% male. Data was analyzed using Pearson's correlation and MANCOVA. Results indicated: Out of the five areas of attributes, one area showed significant (p teacher behaviors within the Evaluation category. Students with high self-efficacy reported faculty who suggested ways to improve, identified strengths and weaknesses, observed frequently, communicated expectations, gives positive reinforcement ad corrects without belittling. This can help faculty develop behaviors that increases student learning and student self-efficacy.

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

    Energy Technology Data Exchange (ETDEWEB)

    Schulte-Altedorneburg, G.; Gebhard, M.; Wohlgemuth, W.A.; Fischer, W.; Zentner, J.; Bohndorf, K. [Department of Radiology, Klinikum Augsburg, Stenglinstrasse 2, 86156 Augsburg (Germany); Wegener, R.; Balzer, T. [Clinical Development Diagnostics and Radiopharmaceuticals II, Schering AG, Berlin (Germany)

    2003-01-01

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

  9. Impact of Simulation and Clinical Experience on Self-efficacy in Nursing Students: Intervention Study.

    Science.gov (United States)

    Kimhi, Einat; Reishtein, Judith L; Cohen, Miri; Friger, Michael; Hurvitz, Nancy; Avraham, Rinat

    2016-01-01

    This study compared the effect of simulation and clinical experience timing on self-confidence/self-efficacy for the nursing process. Using a randomized, double-crossover design, self-efficacy was measured 3 times. Although self-efficacy was significantly higher at time 1 for students who had clinical experience, there was no difference between the groups at the end of the course (time 2). Thus, simulation increased self-confidence/self-efficacy equivalently if placed either before or after clinical experience.

  10. Efficacy and Safety of Saffron Supplementation: Current Clinical Findings.

    Science.gov (United States)

    Broadhead, G K; Chang, A; Grigg, J; McCluskey, P

    2016-12-09

    Saffron (Crocus savitus) is a Middle-Eastern herb with strong antioxidant properties. Its major constituents, safranal, crocin, and crocetin, are also antioxidants and bear structural similarities to other well-known natural antixodant substances, such as zeaxanthin. Given the role of oxidative stress in many diseases, considerable interest has been shown into the potential role of saffron supplementation as a treatment for a range of diseases. In vitro and animal studies have provided evidence that saffron and its constituents may be potent therapies for a range of pathologies, including Alzheimer's disease, age-related macular degeneration (AMD) and cardiac ischemia. Whether these findings translate into clinical efficacy, however, has as of yet been incompletely assessed. This makes assessing the role of saffron supplementation in these diseases difficult. Here, we review the current human clinical evidence supporting saffron supplementation as a treatment for a range of pathologies and the underlying science supporting its use.

  11. Lessons Learned from HIV Vaccine Clinical Efficacy Trials

    Science.gov (United States)

    Day, Tracey A.; Kublin, James G.

    2014-01-01

    The past few years have witnessed many promising advances in HIV prevention strategies involving pre-exposure prophylaxis approaches. Some may now wonder whether an HIV vaccine is still needed, and whether developing one is even possible. The partial efficacy reported in the RV144 trial and the encouraging results of the accompanying immune correlates analysis suggest that an effective HIV vaccine is achievable. These successes have provided a large impetus and guidance for conducting more HIV vaccine trials. A key lesson learned from RV144 is that assessment of HIV acquisition is now a feasible and valuable primary objective for HIV preventive vaccine trials. In this article we review how RV144 and other HIV vaccine efficacy trials have instructed the field and highlight some of the HIV vaccine concepts in clinical development. After a long and significant investment, HIV vaccine clinical research is paying off in the form of valuable lessons that, if applied effectively, will accelerate the path toward a safe and effective vaccine. Together with other HIV prevention approaches, preventive and therapeutic HIV vaccines will be invaluable tools in bringing the epidemic to an end. PMID:24033299

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

    Science.gov (United States)

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

    2016-11-01

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

  13. Immunogenicity and Clinical Efficacy of Influenza Vaccination In Pregnancy

    Directory of Open Access Journals (Sweden)

    Alexander W Kay

    2015-06-01

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

  14. Clinical Governance: Efficacy of Establishment in Mashhad Hospital

    Directory of Open Access Journals (Sweden)

    Davoodi R

    2014-01-01

    Full Text Available Objectives: Clinical governance is a framework in which the organizations providing clinical services are responsible in exchange for the permanent improvement of quality and preserving the service’s high standard. It relies on the responsibility to maintain current levels of care and on clinical governance pillars to improve the quality of future care. Also, it is a concept that attempts to integrate the previous methods and tools in measuring and improving quality of care. Materials and Methods: This descriptive-analytic-interventional study was conducted to evaluate the hospitals of Mashhad before and after the establishment of clinical governance in 2011. Data were collected by both questionnaires and observation. Results: Comparing the range of clinical governance’s pillars obtained, from the selected hospitals, showed a significant improvement in all studied axes following the establishment of clinical governance. The highest effectiveness was related to clinical audit, staff management and training axes, whereas the least effective part was the interaction with patients, their relatives and the community. Conclusion: Regarding the significant difference in the obtained results after the establishment of clinical governance in this study, it could be concluded that the establishment of clinical governance and its performance could remarkably improve the quality of health services.

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

    Directory of Open Access Journals (Sweden)

    David Gonçalves Nordon

    2013-06-01

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

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

    Science.gov (United States)

    Hübner, N-O; Kramer, A

    2010-01-01

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

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

    Science.gov (United States)

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

    2016-04-01

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

  18. 保留括约肌虚挂线法治疗高位肛周脓肿%Clinical Efficacy of Sphincter-retaining and Loose-seton Therapy in Treating Patients with High Perianal Abscess

    Institute of Scientific and Technical Information of China (English)

    伍静; 刘洪; 杨春梅; 何洪波

    2012-01-01

    Objective To investigate the clinical efficacy of sphincter-retaining and loose-seton therapy in treating high perianal abscess. Methods Using randomized controlled trial, 52 patients with high perianal abscess were randomly assigned to treatment group (n=26) treated with sphincter-retaining and loose-seton therapy and the control group (n=26) treated with perianal abscess radical surgery. The incidence of anal fistula 6 months after the treatment, healing time of incision, V AS scores of night pain 1 to 15 day s after treatment, and sequelae of anal function 6 months later were observed and compared. Results Six months after treatment, the incidences of anal fistula of the treatment group and the control group were respectively 4.0% and 3.8% (P > 0.05). The healing time of incision and night pain score of the surgery day and the 14 days after operation in the treatment group were shorter or slighter compared with those in the control group (P < 0.05). After six-month follow-up, the anal function of treatment group was normal, and the control group had a 12.0% incidence of complications, the difference of which was of statistical significance (P < 0.05). Conclusion The sphincter-retaining and loose-seton therapy on high perianal abscess is better than radical surgery in terms of postoperative pain, healing time of incision and protection of anal function.%目的 探讨保留括约肌虚挂线法治疗高位肛周脓肿的临床疗效.方法 2009年10月-2010年10月采用随机对照试验,对52例高位肛周脓肿患者施行手术治疗,其中保留括约肌虚挂线法(治疗组)26例,切开挂线引流法(对照组)26例.对两组患者术后6个月肛瘘发生率、切口愈合时间、术后1~15d每晚疼痛视觉模拟评分(VAS)和术后6个月痊愈患者肛门功能后遗症发生率进行比较.结果 术后6个月,治疗组和对照组肛瘘发生率分别为4.0%和3.8%,差异无统计学意义(P>0.05).术后7~15d治疗组VAS评分均低于

  19. Clinical efficacy of entecavir in treatment of hepatogenous diabetes

    Directory of Open Access Journals (Sweden)

    GOU Wei

    2013-06-01

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

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

    Directory of Open Access Journals (Sweden)

    V N Hodyrev

    2005-01-01

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

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

    Energy Technology Data Exchange (ETDEWEB)

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

    1999-09-01

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

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

    Directory of Open Access Journals (Sweden)

    F. Ashrafzadeh

    2004-07-01

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

  3. Clinical efficacy of lidocaine, mepivacaine, and articaine for local infiltration.

    Science.gov (United States)

    Srisurang, Suttapreyasri; Narit, Leepong; Prisana, Pripatnanont

    2011-02-01

      To assess and compare the efficacy of single buccal and palatal infiltration of lidocaine, mepivacaine, or articaine with 1:100 000 epinephrine by maxillary anesthetic injection.   A double-blinded, randomized, clinical trial was conducted with 33 patients undergoing upper premolar extraction. The patients were randomly allocated into one of three groups, according to the local anesthetic agent used: 2% lidocaine, 2% mepivacaine, or 4% articaine, all with 1:100 000 epinephrine, and were blinded to the anesthetic used. The extent of anesthetization, pulpal anesthetization in adjacent teeth, pain on injection, and adverse effects of the anesthetic agents were assessed.   The extent of anesthetization produced by 4% articaine (42 mm) was statistically more significant (P ≤ 0.05) than 2% lidocaine (33 mm) and 2% mepivacaine (32.5 mm). The successful anesthetization of adjacent teeth occurred more often in the articaine group than in the lidocaine and mepivacine groups, although not to a statistically-significant extent. The pain scores for the injections were comparable between the three groups.   Local anesthetization using 4% articaine with 1:100 000 epinephrine covers a wider area of soft tissue and adjacent teeth than 2% lidocaine or 2% mepivacaine with 1:100 000 epinephrine, which is sufficient for the extraction of one or two teeth. © 2010 Blackwell Publishing Asia Pty Ltd.

  4. Clinical high risk for psychosis

    DEFF Research Database (Denmark)

    van der Steen, Y; Gimpel-Drees, J; Lataster, T

    2017-01-01

    OBJECTIVE: The aim of this study was to assess associations between momentary stress and both affective and psychotic symptoms in everyday life of individuals at clinical high risk (CHR), compared to chronic psychotic patients and healthy controls, in search for evidence of early stress sensitiza...

  5. Exploring the Relationship between Teaching Efficacy and Cultural Efficacy of Novice Science Teachers in High-Needs Schools

    Science.gov (United States)

    Moseley, Christine; Bilica, Kimberly; Wandless, Ana; Gdovin, Ralph

    2014-01-01

    This qualitative case study sought to investigate what relationship exists between teaching efficacy and cultural efficacy of novice science teachers in high-needs, high-minority urban schools. One major theme--the importance of establishing positive teacher-student relationships--surrounding teaching efficacy in the context of cultural efficacy…

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

    DEFF Research Database (Denmark)

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

    2004-01-01

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

  7. Fesoterodine in randomised clinical trials: an updated systematic clinical review of efficacy and safety.

    Science.gov (United States)

    Dell'Utri, Chiara; Digesu, G Alessandro; Bhide, Alka; Khullar, Vik

    2012-10-01

    This is a systematic review of clinical data assessing the safety, efficacy and tolerability of fesoterodine in randomised control trials (RCTs) in the treatment of overactive bladder (OAB). We performed a MEDLINE literature search of articles published between 2005 and 2010 regarding the efficacy and safety of fesoterodine. The US Food and Drug Administration Web site was also searched for RCTs. Two studies demonstrated significant improvement of OAB symptoms with fesoterodine compared with placebo. Two phase III studies showed both doses of fesoterodine to be more effective than placebo for most symptoms. Another phase III trial confirmed the superiority of 8 mg fesoterodine compared with tolterodine ER 4 mg. Dry mouth was the commonest side effect. Fesoterodine is effective for treating OAB symptoms. Its once-daily dosing regime and the flexibility to increase the dose are appealing factors.

  8. Fabrication of high efficacy selective solar absorbers

    CSIR Research Space (South Africa)

    Tile, N

    2012-03-01

    Full Text Available High efficiency tandem selective solar absorber materials of carbon in nickel oxide (C-NiO) composite were fabricated on an aluminium substrate using a simple and cost effective sol-gel process. The process involved preparation of carbon and nickel...

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

    Science.gov (United States)

    Iyer, Nageshwar; Chandna, Shalu; Dhindsa, Abhishek; Damle, Dhanashree; Loomba, Ashish

    2016-01-01

    Aim: The aim of this clinical study was to confirm the plaque removal efficacy of the Colgate 360 Whole Mouth Clean Toothbrush. Study Design: This was a single-center, monadic, case–controlled study with the 7 days duration. Materials and Methods: A total of eighty participants (56 male and 24 female) aged between 18 and 45 years with a minimum of 20 permanent teeth (excluding the third molars) without any prosthetic crowns and an initial plaque score of minimum 1.5 as determined by Modified Quigley-Hein Plaque Index (1970) participated in the study. There were two dropouts during the study duration, one male and one female. The participants were instructed to brush for 1 min, after which plaque index was recorded again. They were then instructed to brush their teeth twice a day for 1 min with the assigned toothbrush (Colgate 360 Whole Mouth Clean Toothbrush) and a commercially available fluoride toothpaste for the next 7 days. On the 7th day, all the participants were recalled for follow-up and plaque examination. The plaque index scores (pre- and post-brushing) were recorded, tabulated, and analyzed statistically. Results: The mean plaque indices reduced after brushing both on day 1 and day 7. There was also a reduction in mean plaque indices from day 1 to day 7. All these reductions were statistically significant (P < 0.001). The reduction in plaque scores was independent of the gender of the participants however female participants showed lower scores as compared to male participants (P < 0.001). Conclusion: The present study demonstrated a significant reduction in plaque scores with the use of Colgate 360 Whole Mouth Clean Soft Toothbrush throughout the study period. Continued use resulted in a further significant reduction in plaque scores irrespective of the gender of participants. PMID:27630494

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

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1998-05-01

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

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

    Directory of Open Access Journals (Sweden)

    Nageshwar Iyer

    2016-01-01

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

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

    Science.gov (United States)

    Kim, Eun-Kyeung; Shin, Sujin

    2017-07-01

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

  13. Fecal microbiota transplantation: current clinical efficacy and future prospects.

    Science.gov (United States)

    Bowman, Kathryn A; Broussard, Elizabeth K; Surawicz, Christina M

    2015-01-01

    Fecal microbiota transplantation (FMT) has gained mainstream attention with its remarkable efficacy in treating recurrent Clostridium difficile infection (RCDI) when there are no other effective therapies. Methods of selecting donors and routes of administration vary among studies, but there are now randomized controlled trials showing efficacy of FMT in treating RCDI. Ongoing trials of FMT for other disease such as inflammatory bowel disease are underway; this therapy should not be used for these conditions unless there is strong evidence for efficacy. Long-term safety data are sorely needed, as well as clarification of regulatory concerns.

  14. Clinical efficacy of radiation synovectomy in digital joint osteoarthritis

    Energy Technology Data Exchange (ETDEWEB)

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

    2005-04-01

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

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

    Science.gov (United States)

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

    2016-01-01

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

  16. 多环黏膜切除术治疗食管高级别上皮内瘤变的临床疗效%Clinical efficacy of multi-band mucosectomy for high-grade esophageal intraepithelial neoplasia

    Institute of Scientific and Technical Information of China (English)

    王慧超; 葛相栓; 钱峰; 刘小玲; 李建平; 赵作静; 王瑞

    2014-01-01

    Objective To investigate the efficacy and safety of multi-band mucosectomy (MBM) for the treatment of high-grade intraepithelial neoplasia.Methods The clinical data of 24 patients with high-grade esophageal intraepithelial neoplasia who were admitted to the Henan Honliv Hospital from April 2011 to October 2012 were retrospectively analyzed.All the 24 patients received MBM,and the operation time,resection of the lesion and complications were observed.All the patients were followed up with gastroscopy at postoperative 1,3,6,12 months.The follow-up was ended in April 2013.Results A total of 26 lesions in 24 patients were resected successfully by MBM (2 patients received MBM twice).The mean operation time was 42 minutes.The mean length of the lesions was 3.1 cm (range,0.8-6.0 cm),and it occupied 3/4 of the circumference of the esophagus to the maximum.The mean number of the band used was 4 (range,1-6).During the operation,bleeding was occurred in 4 patients,and they were cured by hot biopsy forceps.No perforation of the esophagus was detected.The results of post-MBM pathological examination showed that 22 patients were with severe atypical hyperplasia,and 2 were with carcinoma in situ.During the follow-up of 6-24 months,22 patients were cured,and esophageal stricture occurred in 1 patient at post-MBM 1 month,and the symptoms were successfully relieved by endoscopic balloon dilatation.Neoplasia recurrence was observed in 1 patient (2 lesions were resected twice) at post-MBM 3 months,and he received surgical treatment.Histopathological diagnosis showed that he had esophageal squamous cell carcinoma.No stricture or neoplasia was detected by gastroscopy at postoperative month 12.Conclusions MBM is a relatively safe and effective endoscopic technique for the treatment of high-grade esophageal intraepithelial neoplasia.The resection range should not be blindly extended.For patients whose lesions are beyond 3/4 of the circumference of the esophagus in width or with multiple

  17. Neuroimaging in Alzheimer's disease: preclinical challenges toward clinical efficacy.

    Science.gov (United States)

    Dustin, Derek; Hall, Benjamin M; Annapragada, Ananth; Pautler, Robia G

    2016-09-01

    The scope of this review focuses on recent applications in preclinical and clinical magnetic resonance imaging (MRI) toward accomplishing the goals of early detection and responses to therapy in animal models of Alzheimer's disease (AD). Driven by the outstanding efforts of the Alzheimer's Disease Neuroimaging Initiative (ADNI), a truly invaluable resource, the initial use of MRI in AD imaging has been to assess changes in brain anatomy, specifically assessing brain shrinkage and regional changes in white matter tractography using diffusion tensor imaging. However, advances in MRI have led to multiple efforts toward imaging amyloid beta plaques first without and then with the use of MRI contrast agents. These technological advancements have met with limited success and are not yet appropriate for the clinic. Recent developments in molecular imaging inclusive of high-power liposomal-based MRI contrast agents as well as fluorine 19 ((19)F) MRI and manganese enhanced MRI have begun to propel promising advances toward not only plaque imaging but also using MRI to detect perturbations in subcellular processes occurring within the neuron. This review concludes with a discussion about the necessity for the development of novel preclinical models of AD that better recapitulate human AD for the imaging to truly be meaningful and for substantive progress to be made toward understanding and effectively treating AD. Furthermore, the continued support of outstanding programs such as ADNI as well as the development of novel molecular imaging agents and MRI fast scanning sequences will also be requisite to effectively translate preclinical findings to the clinic.

  18. Pre-clinical properties of the alpha 4 beta 2 nicotinic acetylcholine receptor partial agonists varenicline, cytisine and dianicline translate to clinical efficacy for nicotine dependence

    NARCIS (Netherlands)

    Rollema, H.; Shrikhande, A.; Ward, K. M.; Tingley, F. D.; Coe, J. W.; O'Neill, B. T.; Tseng, E.; Wang, E. Q.; Mather, R. J.; Hurst, R. S.; Williams, K. E.; de Vries, M.; Cremers, T.; Bertrand, S.; Bertrand, D.

    2010-01-01

    Background and purpose: Smoking cessation trials with three high-affinity partial agonists of alpha 4 beta 2 neuronal nicotinic acetylcholine receptors (nAChRs) have demonstrated differences in their clinical efficacy. This work examines the origin of the differences by taking into account brain exp

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

    Science.gov (United States)

    Bhusal, Santosh; Diomampo, Sherilyn; Magrey, Marina N

    2016-01-01

    Fibromyalgia is a chronic debilitating medical syndrome with limited therapeutic options. Pregabalin, an anticonvulsant and α-2-Δ subunit receptor ligand, is one of the anchor drugs approved by the US Food and Drug Administration for the treatment of fibromyalgia. The drug has shown clinically meaningful benefits across multiple symptom domains of fibromyalgia. Efficacy of pregabalin in fibromyalgia pain has been evaluated in at least five high-quality randomized trials, two long-term extension studies, a meta-analysis, a Cochrane database systematic review, and several post hoc analyses. These studies also hint towards a meaningful benefit on sleep, functioning, quality of life, and work productivity. Side effects of pregabalin, although common, are mild to moderate in intensity. They are noted early during therapy, improve or disappear with dose reduction, and are not usually life- or organ threatening. In most patients, tolerance develops to the most common side effects, dizziness, and somnolence, with time. With close clinical monitoring at initiation or dose titration, pregabalin can be effectively used in primary care setting. Pregabalin is cost saving with long-term use and its cost-effectiveness profile is comparable, if not better, to that of other drugs used in fibromyalgia. In the present era of limited therapeutic options, pregabalin undoubtedly retains its role as one of cardinal drugs used in the treatment of fibromyalgia. This review intends to discuss the clinical utility of pregabalin in the management of fibromyalgia with a focus on efficacy, safety, and cost-effectiveness. PMID:26937205

  20. Fecal microbiota transplantation: current clinical efficacy and future prospects

    Directory of Open Access Journals (Sweden)

    Bowman KA

    2015-10-01

    Full Text Available Kathryn A Bowman,1 Elizabeth K Broussard,2 Christina M Surawicz2 1Department of Medicine, 2Division of Gastroenterology, University of Washington School of Medicine, Seattle, WA, USA Abstract: Fecal microbiota transplantation (FMT has gained mainstream attention with its remarkable efficacy in treating recurrent Clostridium difficile infection (RCDI when there are no other effective therapies. Methods of selecting donors and routes of administration vary among studies, but there are now randomized controlled trials showing efficacy of FMT in treating RCDI. Ongoing trials of FMT for other disease such as inflammatory bowel disease are underway; this therapy should not be used for these conditions unless there is strong evidence for efficacy. Long-term safety data are sorely needed, as well as clarification of regulatory concerns. Keywords: fecal microbiota transplant, recurrent Clostridium difficile infection, Clostridium difficile infection, microbiome, inflammatory bowel disease

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

    Directory of Open Access Journals (Sweden)

    Zou C

    2013-11-01

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

  2. Evidence of clinically relevant efficacy for dietary supplements and nutraceuticals.

    Science.gov (United States)

    Cicero, Arrigo F G; Borghi, Claudio

    2013-06-01

    Beyond the well-known effects on blood pressure (BP) of the DASH and the Mediterranean diets, a large number of studies have investigated the possible a BP-lowering effect from different dietary supplements and nutraceuticals, mostly antioxidant agents with a high tolerability and safety profile. In particular, a relatively large body of evidence support the use of potassium, L-arginine, vitamin C, cocoa flavonoids, coenzyme Q10, controlled-release melatonin, and aged garlic extract. However there is a need for data about the long-term safety of a large part of these products. Moreover, further clinical research is advisable to identify between the available active nutraceuticals and those with the best cost-effectiveness and risk-benefit ratio for widespread use in a general population with low added cardiovascular risk related to uncomplicated hypertension.

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

    Directory of Open Access Journals (Sweden)

    Ščuka Leon

    2005-01-01

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

  4. Cryolipolysis for noninvasive body contouring: clinical efficacy and patient satisfaction

    Directory of Open Access Journals (Sweden)

    Krueger N

    2014-06-01

    Full Text Available Nils Krueger,1 Sophia V Mai,2 Stefanie Luebberding,1 Neil S Sadick3 1Rosenpark Research, Darmstadt, Germany; 2Department of Dermatology, Louisiana State University, New Orleans, LA, 3Department of Dermatology, Weill Cornell Medical College, New York, NY, USA Abstract: In recent years, a number of modalities have become available for the noninvasive reduction of adipose tissue, including cryolipolysis, radiofrequency, low-level laser, and high-intensity focused ultrasound. Each technology employs a different mechanism of action to cause apoptosis or necrosis of the targeted adipocytes. Among these technologies, cryolipolysis has not only been commercially available for the longest time, but has also been best researched including in vitro and animal models and randomized controlled clinical trials in humans. The principle behind cryolipolysis exploits the premise that adipocytes are more susceptible to cooling than other skin cells. The precise application of cold temperatures triggers apoptosis of the adipocytes, which invokes an inflammatory response and leads to slow digestion by surrounding macrophages. In clinical studies, cryolipolysis was shown to reduce subcutaneous fat at the treatment site by up to 25% after one treatment. Improvements were seen in 86% of treated subjects. At 73%, the patient satisfaction rate is higher than with other technologies used for noninvasive lipolysis. Cryolipolysis has been proven to be a very safe method for body contouring, and is accomplished with only minimal discomfort. Expected side effects are temporary erythema, bruising, and transient numbness that usually resolve within 14 days after treatment. With a prevalence of 0.1%, the most common complaint is late-onset pain, occurring 2 weeks post-procedure, which resolves without intervention. Although no procedure has been accepted as the gold standard for noninvasive body contouring as yet, cryolipolysis is considered to be both safe and efficient with a

  5. Clinical efficacy of a chlorhexidine-delivering toothbrush

    NARCIS (Netherlands)

    Van Strydonck, D.A.C.; Timmerman, M.F.; van der Velden, U.; van der Weijden, G.A.

    2008-01-01

    Objectives: Evaluate the efficacy and safety of an experimental toothbrush with a slow-release system of chlorhexidine (CHX) and determine its ability to inhibit plaque, bleeding, staining and oral tissue abnormalities during 6 weeks of use. Material and Methods: One hundred and fifty healthy volunt

  6. Clinical efficacy and safety of catheter ablation for atrial fibrillation in elderly patients

    Institute of Scientific and Technical Information of China (English)

    董静

    2013-01-01

    Objective To evaluate the clinical efficacy and safty of catheter ablation for atrial fibrillation in elderly patients.Methods From September 2008 to October 2011,a total of 420 consecutive patients undergoing cathete rablation

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

    Directory of Open Access Journals (Sweden)

    Yo Han Ahn

    2014-06-01

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

  8. Computerized Neuropsychological Assessment in Aging: Testing Efficacy and Clinical Ecology of Different Interfaces

    Directory of Open Access Journals (Sweden)

    Matteo Canini

    2014-01-01

    Full Text Available Digital technologies have opened new opportunities for psychological testing, allowing new computerized testing tools to be developed and/or paper and pencil testing tools to be translated to new computerized devices. The question that rises is whether these implementations may introduce some technology-specific effects to be considered in neuropsychological evaluations. Two core aspects have been investigated in this work: the efficacy of tests and the clinical ecology of their administration (the ability to measure real-world test performance, specifically (1 the testing efficacy of a computerized test when response to stimuli is measured using a touch-screen compared to a conventional mouse-control response device; (2 the testing efficacy of a computerized test with respect to different input modalities (visual versus verbal; and (3 the ecology of two computerized assessment modalities (touch-screen and mouse-control, including preference measurements of participants. Our results suggest that (1 touch-screen devices are suitable for administering experimental tasks requiring precise timings for detection, (2 intrinsic nature of neuropsychological tests should always be respected in terms of stimuli presentation when translated to new digitalized environment, and (3 touch-screen devices result in ecological instruments being proposed for the computerized administration of neuropsychological tests with a high level of preference from elderly people.

  9. Efficacy of a single high oxfendazole dose against gastrointestinal nematodes in naturally infected pigs.

    Science.gov (United States)

    Alvarez, Luis; Saumell, Carlos; Fusé, Luis; Moreno, Laura; Ceballos, Laura; Domingue, Gilbert; Donadeu, Meritxell; Dungu, Baptiste; Lanusse, Carlos

    2013-05-01

    The goal of the current experiment was to assess the clinical efficacy of oxfendazole (OFZ) administered as a single oral dose (30 mg/kg) to pigs naturally parasitized with Ascaris suum, Oesophagostomum spp., Metastrongylus spp. and Trichuris suis. Thirty-six local ecotype piglets were divided into three independent experiments, named I, II and III (n=12 each), respectively. Each experiment involved two different groups (n=6): Untreated Control and OFZ treated. Animals were naturally parasitized with A. suum (Experiments I, II and III), Oesophagostomum spp. (Experiments I and II), T. suis (Experiments II and III) and Metastrongylus spp. (Experiment I). Pigs in the treated group received OFZ (Synanthic(®), Merial Ltd., 9.06% suspension) orally at 30 mg/kg dose. At five (5) days post-treatment, animals were sacrificed and the clinical efficacy of the OFZ treatment was established following the currently available WAAVP guidelines for a controlled efficacy test. None of the animals involved in this experiment showed any adverse events during the study. OFZ treatment given as a single 30 mg/kg oral dose showed a 100% efficacy against all the nematode parasites present in the three experiments. In conclusion, under the current experimental conditions, OFZ orally administered to naturally parasitized piglets at a single dose of 30 mg/kg was safe and highly efficacious (100%) against adult stages of A. suum, Oesophagostomum spp., T. suis and Metastrongylus spp.

  10. The impact of clinical simulation on learner self-efficacy in pre-registration nursing education.

    Science.gov (United States)

    Pike, Tamsin; O'Donnell, Victoria

    2010-07-01

    Clinical simulation is becoming increasingly popular in pre-registration nursing education. Incorporating teaching and learning strategies that enhance learner self-efficacy will theoretically improve clinical competence (Bandura, 1986, 1997). This paper presents the findings of a study that aimed to explore the impact of clinical simulation on self-efficacy beliefs amongst pre-registration nurses. A preliminary study (Pike, 2008) used a pre- and post-test design to measure learner self-efficacy before and after a clinical simulation session. Qualitative responses to questions on the post-test questionnaire provided themes to explore in a focus group interview with a convenience sample of nine participants. Thematic content analysis of the interview highlighted two principal findings. Firstly, students described low levels of self-efficacy with regards to communication skills, an area identified as a priority within pre-registration nursing education (NMC, 2007a). Second, students highlighted the need for learning experiences within clinical simulation to be more authentic, to improve the theory to practice gap. It is argued by incorporating strategies within clinical simulation that enhance learner self-efficacy, overall clinical competence will be improved. Suggestions for how pedagogical approaches may be developed within clinical simulation are discussed, whilst acknowledging the limitations of the small scale nature of the study.

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2017-03-15

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

  12. Fecal microbiota transplantation: current clinical efficacy and future prospects

    OpenAIRE

    Bowman KA; Broussard EK; Surawicz CM

    2015-01-01

    Kathryn A Bowman,1 Elizabeth K Broussard,2 Christina M Surawicz2 1Department of Medicine, 2Division of Gastroenterology, University of Washington School of Medicine, Seattle, WA, USA Abstract: Fecal microbiota transplantation (FMT) has gained mainstream attention with its remarkable efficacy in treating recurrent Clostridium difficile infection (RCDI) when there are no other effective therapies. Methods of selecting donors and routes of administration vary among studies, but there are now ra...

  13. Clinical efficacy of combined therapy for perianal eczema caused by anal diseases in 160 cases

    Directory of Open Access Journals (Sweden)

    Zhi-Chao LIU

    2007-01-01

    Full Text Available Perianal eczema is a kind of inflammatory dermatosis on the perianal skin and mucosa. The aim of the study was to evaluate the clinical efficacy of the combined therapy of medicine and operation for the perianal eczema caused by the anal diseases such as hemorrhoids, fissures and fistulas. One hundred and sixty patients with perianal eczema were involved in this study. They were randomly divided into four groups and treated by different therapies for four weeks respectively. Group A (40 patients was only treated with medicine, Group B (40 patients only with operation, Group C (40 patients firstly with medicine and then with operation and Group D (40 patients firstly with operation and then with medicine. The efficacy was determined as reduction of lesion size relative to initial size. The cure rate was 22.50%, 32.50%, 57.50% and 45.00% in Group A, B, C and D, respectively. The effective rate was 40.00%, 52.50%, 85.00% and 75.00%, respectively. The efficacy was significantly different (H=20.8689, g = 3, P value =0.0001. The results of group comparison showed that there were significant difference between Group C and Group A, Group C and Group B, Group D and Group A (all P values, < 0.05. It was concluded that the combined therapy of medicine and operation is optimal choice for the perianal eczema caused by the anal diseases such as hemorrhoids, fissures, and fistula. It highly improves the cure rate and efficacy rate.

  14. New medicinal products for chronic heart failure: advances in clinical trial design and efficacy assessment.

    Science.gov (United States)

    Cowie, Martin R; Filippatos, Gerasimos S; Alonso Garcia, Maria de Los Angeles; Anker, Stefan D; Baczynska, Anna; Bloomfield, Daniel M; Borentain, Maria; Bruins Slot, Karsten; Cronin, Maureen; Doevendans, Pieter A; El-Gazayerly, Amany; Gimpelewicz, Claudio; Honarpour, Narimon; Janmohamed, Salim; Janssen, Heidi; Kim, Albert M; Lautsch, Dominik; Laws, Ian; Lefkowitz, Martin; Lopez-Sendon, Jose; Lyon, Alexander R; Malik, Fady I; McMurray, John J V; Metra, Marco; Figueroa Perez, Santiago; Pfeffer, Marc A; Pocock, Stuart J; Ponikowski, Piotr; Prasad, Krishna; Richard-Lordereau, Isabelle; Roessig, Lothar; Rosano, Giuseppe M C; Sherman, Warren; Stough, Wendy Gattis; Swedberg, Karl; Tyl, Benoit; Zannad, Faiez; Boulton, Caroline; De Graeff, Pieter

    2017-06-01

    Despite the availability of a number of different classes of therapeutic agents with proven efficacy in heart failure, the clinical course of heart failure patients is characterized by a reduction in life expectancy, a progressive decline in health-related quality of life and functional status, as well as a high risk of hospitalization. New approaches are needed to address the unmet medical needs of this patient population. The European Medicines Agency (EMA) is undertaking a revision of its Guideline on Clinical Investigation of Medicinal Products for the Treatment of Chronic Heart Failure. The draft version of the Guideline was released for public consultation in January 2016. The Cardiovascular Round Table of the European Society of Cardiology (ESC), in partnership with the Heart Failure Association of the ESC, convened a dedicated two-day workshop to discuss three main topic areas of major interest in the field and addressed in this draft EMA guideline: (i) assessment of efficacy (i.e. endpoint selection and statistical analysis); (ii) clinical trial design (i.e. issues pertaining to patient population, optimal medical therapy, run-in period); and (iii) research approaches for testing novel therapeutic principles (i.e. cell therapy). This paper summarizes the key outputs from the workshop, reviews areas of expert consensus, and identifies gaps that require further research or discussion. Collaboration between regulators, industry, clinical trialists, cardiologists, health technology assessment bodies, payers, and patient organizations is critical to address the ongoing challenge of heart failure and to ensure the development and market access of new therapeutics in a scientifically robust, practical and safe way. © 2017 The Authors. European Journal of Heart Failure © 2017 European Society of Cardiology.

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

    Science.gov (United States)

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

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

  16. Efficacy of extended cefquinome treatment of clinical Staphylococcus aureus mastitis

    NARCIS (Netherlands)

    Swinkels, J. M.; Cox, P.; Schukken, Y. H.; Lam, T. J G M

    2013-01-01

    Clinical Staphylococcus aureus mastitis is difficult to cure. Extended antimicrobial treatment is often advocated as a practical approach to improve cure rates; however, scientific evidence of this hypothesis is lacking. A multi-centered, nonblinded, randomized, positive-controlled clinical trial wa

  17. CLINICAL EFFICACY OF CENTPORPAZINE-A NEW ANTIDEPRESSANT

    Science.gov (United States)

    Srivastava, J.S.; Gupta, P.P.; Asthana, O.P.; Nityanand, S.; Devi, S.; Doongaji, D.R.; Sethi, B.B.; Singh, Gurmeet; Srimal, R.C.; Dhawan, B.N.

    1992-01-01

    Efficacy of centpropazine, a new antidepressant, has been evaluated in forty two patients of endogenous depression. The 4 week open trial was carried out in a dose-range of 40 to 120mg per day. A significant lowering of Hamilton Depression Rating Scale (HDRS) score was observed in 34 patient. The antidepressant effect could be detected in 9 patients within one week, in 28 cases in two weeks and in all the 34 patients by third week. Giddiness, headache, dryness of mouth and weakness were reported by 11 patients. PMID:21776129

  18. [A clinical study on the efficacy of ceftazidime and aspoxicillin in chorioamnionitis. Abdominal Infections Research Group].

    Science.gov (United States)

    Chimura, T; Hirayama, T; Oda, T; Saito, N; Sato, S; Numazaki, M

    1994-09-01

    Chorioamnionitis as a complication of threatened abortion and preterm labor and preterm PROM were treated with ceftazidime (CAZ) and aspoxicillin (ASPC) as a primary therapy. The following results were obtained. 1. Cases of threatened abortion and preterm labor (n = 25) and preterm PROM (n = 5) were treated with 2-4 g CAZ/day alone (n = 14) or in combination with 4 g ASPC/day (n = 16) along with a uterine contraction inhibitor (ritodrine hydrochloride etc. n = 28) and clinical evaluation was made. 2. In the cases of threatened abortion and preterm labor the efficacy ratio was 24/25 (96%). In the cases of preterm PROM, the latent period-delaying effect was observed in five out of the five patients. Upon analysis of the tocolysis index in the group of threatened abortion and preterm labor, the index values > or = 5 were observed in 12 out of 25 (60%), and the delivery incidence before the 35th week of gestation was 4/25 (16%). In all patients, the incidence of delivery after the 36th week of gestation was 24/30 (80%). 3. Bacteriological examinations showed a high detection rate for Gram-positive bacteria, and the combination effect between ASPC and CAZ was demonstrated against all 9 isolates examined. The above results indicated a high efficacy as well as safety of the combination of CAZ and ASPC as a primary therapeutic means against chorioamnionitis.

  19. The Efficacy of High-Intensity Focused Ultrasound (HIFU) in Advanced Pancreatic Cancer

    Institute of Scientific and Technical Information of China (English)

    Bo Xie; Jiajun Ling; Weiming Zhang; Xueqin Huang; Jihua Zhen; Yanzhe Huang

    2008-01-01

    OBJECTIVE To observe the efficacy of high-intensity focused ultrasound (HIFU)in the treatment of late-stage pancreatic cancer.METHODS Sixteen patients with advanced pancreatic cancer received HIFU therapy.Evaluation of efficacy was made on the basis of changes in clinical symptoms and variations in the tumor echo and size.RESULTS Clinical symptoms such as pain were significantly alleviated,echo of the tumor was enhanced with B-US and the quality of life such as eating,sleeping and mental status was markedly improved;no serious complications were observed.CONCLUSION The use of HIFU in the treatment of advanced pancreatic cancer is feasible and safe.It is effective in killing the carcinoma cells and alleviaring pain.This technique may offer non-invasive therapy for the treatment of patients with late-stage pancreatic cancer.

  20. 生石膏治疗小儿发高烧114例临床疗效观察%Clinical efficacy observation on treating 114 cases of high fever in children with gypsum

    Institute of Scientific and Technical Information of China (English)

    王艳霞

    2013-01-01

    Objective:To research the clinical effect of gypsum on treating high fever in children. Methods:With contrast treatment method, children with high fever admitted to our hospital were taken 1∶1 in proportion divided into experimental group and control group. The experimental group patients were given gypsum treatment; patients in the control group only received routine nursing. After the experimental period, the patient’s therapeutic effects were compared. Results: The experimental group had 20 cases bring down a fever within 24h, accounted for 35%, bring down a fever within 48h have 36 cases, accounted for 63.1%, bring down a fever after 48h 1 case, accounting for 1.7%, 48h bring down a fever rate was 98.3%. Conclusion: The effect of gypsum on treating high fever in children compared with conventional methods has fewer side effects, worthy of a wide clinical application.%目的:研究生石膏对于小儿高烧病患的临床治疗效果。方法:采用对比治疗的方法,将我院收治的小儿高烧病患按照1∶1的人数比例分为实验组和对照组,对实验组病患给予生石膏治疗,对照组病患仅给予常规护理,实验期结束后,比较两组病患的治疗效果。结果:实验组病患24h以内退烧人数20例,占比35.0%,48h以内退烧人数36例,占比63.1%,48h以后退烧人数1例,占比1.7%,48h退烧率为98.3%。结论:生石膏治疗小儿高烧相较于常规方法效果好,副作用少,经济方便明智的临床推广。

  1. Clinical Strategies to Enhance the Efficacy of Nicotine Replacement Therapy for Smoking Cessation: A Review of the Literature

    Science.gov (United States)

    Carpenter, Matthew J.; Jardin, Bianca F.; Burris, Jessica L.; Mathew, Amanda R.; Schnoll, Robert A.; Rigotti, Nancy A.; Cummings, K. Michael

    2013-01-01

    A number of smoking cessation pharmacotherapies have led to increases in quitting and thus to significant benefits to public health. Among existing medications, nicotine replacement therapy (NRT) has been available the longest, has the largest literature base in support, and is the only option for over-the-counter access. While the short term efficacy of NRT is well documented in clinical trials, long term abstinence rates associated with using NRT are modest, as most smokers will relapse. This literature review examines emerging clinical strategies to improve NRT efficacy. After an initial overview of NRT and its FDA-approved indications for use, we review randomized trials in which clinical delivery of NRT was manipulated and tested, in an attempt to enhance efficacy, through a) duration of use (pre-quit and extended use), b) amount of use (high dose and combination NRT), c) tailoring to specific smoker groups (genotype and phenotype), or d) use of NRT for novel purposes (relapse prevention, temporary abstinence, cessation induction). Outcomes vary within and across topic area, and we highlight areas that offer stronger promise. Combination NRT likely represents the most promising strategy moving forward; other clinical strategies offer conflicting evidence but deserve further testing (pre-quit NRT or tailored treatment), or offer potential utility but are in need of further, direct tests. Some areas, though based on a limited set of studies, do not offer great promise (high dose and extended treatment NRT). We conclude with a brief discussion of emergent NRT products (e.g., oral nicotine spray, among others), which may ultimately offer greater efficacy than current formulations. In order to further lower the prevalence of smoking, novel strategies designed to optimize NRT efficacy are needed. PMID:23572407

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

    Directory of Open Access Journals (Sweden)

    Bhusal S

    2016-02-01

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

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

    DEFF Research Database (Denmark)

    Nørgaard, Birgitte; Draborg, Eva; Vestergaard, Erik

    2013-01-01

    and competences to engage in fruitful interprofessional teamwork. The aim of this study was to assess the impact of an interprofessional training program on students’ self-efficacy in interprofessional collaboration. Methods: The study was designed as a quasi-experiment with an intervention group (239 students...... completed before and after the students’ clinical training. Results: In the simple statistical analysis, all four self-efficacy scores for the ICS group improved over time although one score (Q4) change did not reach statistical significance (p=0.08). After adjustment for profession, gender, baseline...... difference between the two groups and the score change for the comparison group, the ICS group’s self-efficacy score gain remained statistically significant. Conclusion: The study showed that interprofessional training improved students’ perception of self-efficacy more than traditional clinical training....

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

    Science.gov (United States)

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

    2014-06-16

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

  5. Caprine herpesvirus 1 (CpHV-1) vaginal infection of goats: clinical efficacy of fig latex.

    Science.gov (United States)

    Camero, Michele; Marinaro, Mariarosaria; Losurdo, Michele; Larocca, Vittorio; Bodnar, Livia; Patruno, Giovanni; Buonavoglia, Canio; Tempesta, Maria

    2016-01-01

    The latex of Ficus carica Linn. (Moraceae) has been shown to interfere with the replication of caprine herpesvirus (CpHV)-1 in vitro. The present study was undertaken to determine the efficacy of vaginal administration of fig latex in goats experimentally infected with CpHV-1. The fig latex reduced the clinical signs of the herpetic disease although it slightly influenced the titres of CpHV-1 shed. Thus, the fig latex maintained a partial efficacy in vivo.

  6. CLINICAL AND IMMUNOPATHOLOGIC CHARACTERISTICS OF EARLY NEONATAL SEPSIS IN INFANTS OF DIFFERENT GESTATIONAL AGE AND CLINICAL AND ECONOMICAL EVALUATION OF IMMUNOSUPPORTIVE THERAPY EFFICACY

    Directory of Open Access Journals (Sweden)

    I.G. Soldatova

    2011-01-01

    Full Text Available Study objective — to study clinical and immunopathologic characteristics of early neonatal sepsis in infants of different gestational age and to perform clinical and economical evaluation of immunosupportive therapy with Pentaglobin efficacy in complex treatment of this disease. 79 infants diagnosed with neonatal sepsis were included into prospective study. These patients were divided into 3 subgroups in order to evaluate clinical and economical efficacy of immunosupportive therapy: subgroup A (n = 38 — patients receiving. Pentaglobin as part of basic complex treatment from 3–6 days of life; subgroup B (n = 27 — from 7–10 days of life; subgroup C  (n = 27 — patients treated without Pentaglobin. Proven high clinical and economical efficacy of immunoglobulin preparations as a part of complex treatment of neonatal sepsis allows to recommend this type of therapy for a wide application in neonatology as a part of neonatal sepsis treatment.Key words: early neonatal sepsis, prematurity, extremely low body mass, immunosupportive therapy, intravenous immunoglobines, clinical and economical analysis, neonatal sepsis. (Voprosy sovremennoi pediatrii — Current Pediatrics. — 2011; 10 (6: 52–61

  7. Joint modeling of clinical efficacy and safety with an application to diabetes studies.

    Science.gov (United States)

    Zhao, Yang; Shen, Wei; Fu, Haoda

    2013-01-01

    The purpose of drug development is to evaluate a drug's efficacy and safety profile. For a personalized medicine, it is important for patients and health care providers to understand the efficacy and safety trade-off when selecting a dose for a patient. In this article, we propose three different methods for jointly modeling the clinical safety and efficacy endpoints. These three methods model the correlation relationship in three different ways: modeling the joint distribution by a copula method, modeling conditional distributions, and modeling their correlations through individual means by a hierarchical model. We compare these three methods through simulations and apply these methods to a data set from a diabetes study.

  8. Efficacy of a family practice-based lifestyle intervention program to increase physical activity and reduce clinical and physiological markers of vascular health in patients with high normal blood pressure and/or high normal blood glucose (SNAC: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Overend Tom

    2011-02-01

    Full Text Available Abstract Background Previous interventions to increase physical activity and reduce cardiovascular risk factors have been targeted at individuals with established disease; less attention has been given to intervention among individuals with high risk for disease nor has there been determination of the influence of setting in which the intervention is provided. In particular, family practice represents an ideal setting for the provision and long-term maintenance of lifestyle interventions for patients at risk (ie high-normal blood pressure or impaired glucose tolerance. Methods/design The Staged Nutrition and Activity Counseling (SNAC study is a randomized clustered design clinical trial that will investigate the effectiveness and efficacy of a multi-component lifestyle intervention on cardiovascular disease risk factors and vascular function in patients at risk in primary care. Patients will be randomized by practice to either a standard of care lifestyle intervention or a behaviourally-based, matched prescriptive physical activity and diet change program. The primary goal is to increase physical activity and improve dietary intake according to Canada's Guides to Physical Activity Healthy Eating over 24 months. The primary intention to treat analysis will compare behavioral, physiological and metabolic outcomes at 6, 12 and 24 months post-randomization including estimation of incident hypertension and/or diabetes. Discussion The design features of our trial, and the practical problems (and solutions associated with implementing these design features, particularly those that result in potential delay between recruitment, baseline data collection, randomization, intervention, and assessment will be discussed. Results of the SNAC trial will provide scientific rationale for the implementation of this lifestyle intervention in primary care. Trial registration ISRCTN: ISRCTN:42921300

  9. Does rectal indomethacin eliminate the need for prophylactic pancreatic stent placement in patients undergoing high-risk ERCP? Post hoc efficacy and cost-benefit analyses using prospective clinical trial data.

    Science.gov (United States)

    Elmunzer, B Joseph; Higgins, Peter D R; Saini, Sameer D; Scheiman, James M; Parker, Robert A; Chak, Amitabh; Romagnuolo, Joseph; Mosler, Patrick; Hayward, Rodney A; Elta, Grace H; Korsnes, Sheryl J; Schmidt, Suzette E; Sherman, Stuart; Lehman, Glen A; Fogel, Evan L

    2013-03-01

    A recent large-scale randomized controlled trial (RCT) demonstrated that rectal indomethacin administration is effective in addition to pancreatic stent placement (PSP) for preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in high-risk cases. We performed a post hoc analysis of this RCT to explore whether rectal indomethacin can replace PSP in the prevention of PEP and to estimate the potential cost savings of such an approach. We retrospectively classified RCT subjects into four prevention groups: (1) no prophylaxis, (2) PSP alone, (3) rectal indomethacin alone, and (4) the combination of PSP and indomethacin. Multivariable logistic regression was used to adjust for imbalances in the prevalence of risk factors for PEP between the groups. Based on these adjusted PEP rates, we conducted an economic analysis comparing the costs associated with PEP prevention strategies employing rectal indomethacin alone, PSP alone, or the combination of both. After adjusting for risk using two different logistic regression models, rectal indomethacin alone appeared to be more effective for preventing PEP than no prophylaxis, PSP alone, and the combination of indomethacin and PSP. Economic analysis revealed that indomethacin alone was a cost-saving strategy in 96% of Monte Carlo trials. A prevention strategy employing rectal indomethacin alone could save approximately $150 million annually in the United States compared with a strategy of PSP alone, and $85 million compared with a strategy of indomethacin and PSP. This hypothesis-generating study suggests that prophylactic rectal indomethacin could replace PSP in patients undergoing high-risk ERCP, potentially improving clinical outcomes and reducing healthcare costs. A RCT comparing rectal indomethacin alone vs. indomethacin plus PSP is needed.

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

    Science.gov (United States)

    Calik, Michael W

    2017-01-01

    Narcolepsy is a neurological disease that affects 1 in 2,000 individuals and is characterized by excessive daytime sleepiness (EDS). In 60–70% of individuals with narcolepsy, it is also characterized by cataplexy or a sudden loss of muscle tone that is triggered by positive or negative emotions. Narcolepsy decreases the quality of life of the afflicted individuals. Currently used drugs treat EDS alone (modafinil/armodafinil, methylphenidate, and amphetamine), cataplexy alone (“off-label” use of antidepressants), or both EDS and cataplexy (sodium oxybate). These drugs have abuse, tolerability, and adherence issues. A greater diversity of drug options is needed to treat narcolepsy. The small molecule drug, pitolisant, acts as an inverse agonist/antagonist at the H3 receptor, thus increasing histaminergic tone in the wake promoting system of the brain. Pitolisant has been studied in animal models of narcolepsy and used in clinical trials as a treatment for narcolepsy. A comprehensive search of online databases (eg, Medline, PubMed, EMBASE, the Cochrane Library Database, Ovid MEDLINE, Europe PubMed Central, EBSCOhost CINAHL, ProQuest Research Library, Google Scholar, and ClinicalTrials.gov) was performed. Nonrandomized and randomized studies were included. This review focuses on the outcomes of four clinical trials of pitolisant to treat narcolepsy. These four trials show that pitolisant is an effective drug to treat EDS and cataplexy in narcolepsy. PMID:28490912

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

    Science.gov (United States)

    Calik, Michael W

    2017-01-01

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

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

    Science.gov (United States)

    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.

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

    Directory of Open Access Journals (Sweden)

    Calik MW

    2017-04-01

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

  14. Mediating effect of self-efficacy in relationship between emotional intelligence and clinical communication competency of nurses

    OpenAIRE

    B. Zhu; C.-R. Chen; Z.-Y. Shi; H.-X. Liang; Liu, B.

    2016-01-01

    Objective: This study investigates the emotional intelligence (EI), self-efficacy, and clinical communication ability of clinical nurses to explore the correlation among these three variables, and verify the mediating effect of self-efficacy on relationship between EI and communication skills. Methods: A total of 865 nurses were recruited and investigated using Wong and Law's Emotional Intelligence Scale, General Self-Efficacy Scale, and nurse clinical communication scale. Results: The ...

  15. The influence of clinical terminology on self-efficacy for voice.

    Science.gov (United States)

    Gillespie, Amanda I; Abbott, Katherine Verdolini

    2011-10-01

    Self-efficacy is defined as one's belief in one's ability to carry out a specific behavior successfully. The current study's objective is to obtain initial evidence in support of the hypothesis that the terms 'vocal abuse/misuse' have the potential to harm self-efficacy for voice and may impact adherence with therapeutic directives. Teachers with voice problems were exposed to the terms 'abuse/misuse' or 'phonotrauma/muscle tension' as describing the origin of common voice problems. Pre- and post-exposures, subjects completed a Voice Self-Efficacy Questionnaire that was specially designed for the study. Results provide preliminary support for the hypothesis that clinical exposure to 'abuse/misuse' terminology may harm normal increases in self-efficacy for voice that are generally expected following education about medical conditions.

  16. Ten years' clinical experience with biosimilar human growth hormone: a review of efficacy data.

    Science.gov (United States)

    López-Siguero, Juan Pedro; Pfäffle, Roland; Chanson, Philippe; Szalecki, Mieczyslaw; Höbel, Nadja; Zabransky, Markus

    2017-01-01

    In 2006, the European Medicines Agency (EMA) approved Omnitrope(®) as a biosimilar recombinant human growth hormone (rhGH), on the basis of comparable quality, safety, and efficacy to the reference medicine (Genotropin(®), Pfizer). Data continue to be collected on the long-term efficacy of biosimilar rhGH from several on-going postapproval studies. Particular topics of interest include efficacy in indications granted on the basis of extrapolation, and whether efficacy of growth hormone treatment is affected when patients are changed to biosimilar rhGH from other rhGH products. Data from clinical development studies and 10 years of postapproval experience affirm the clinical efficacy and effectiveness of biosimilar rhGH across all approved indications. In addition, the decade of experience with biosimilar rhGH since it was approved in Europe confirms the scientific validity of the biosimilar pathway and the approval process. Concerns about clinical effect in extrapolated indications, and also about the impact of changing from other rhGH preparations, have been alleviated. Biosimilar rhGH is an effective treatment option for children who require therapy with rhGH.

  17. Examination of Urban High School Dropouts with High Self-Efficacy: A Phenomenological Study

    Science.gov (United States)

    Bayles, Ronald

    2012-01-01

    The purpose of this study was to explore the lived experience of urban students in Central Alabama with high self-efficacy who have dropped out of school to pursue a GED. This study: (a) provided a platform that gave voice to students to share their lived experience as they made the decision to drop out of high school, (b) identified the character…

  18. Comparative analysis of therapeutic efficacy of 131I in different clinical stages postoperative patients with papillary thyroid carcinoma

    Institute of Scientific and Technical Information of China (English)

    Li Zhao; Shuyao Zuo; Guoming Wang

    2012-01-01

    Objective: The aim of this study was to compare the effect of 131I therapy of different clinical stages in postopera-tive patients with papillary thyroid carcinoma (PTC). Methods: Eighty-seven PTC patients after surgery ablated with high doses of 131I from 2004 to 2010 were retrospectively reviewed. The efficacy of 131I therapy was assessed by three diagnostics that serum thyroglobulin (Tg) was normal or significantly reduced, 131I whole body scan (131I-WBS) was negative or the metas-tases shrank or the number of them decreased and new metastases was not found in cervical ultrasound examination. The χ2 test was used to analyze 3 factors which might affect the therapeutic efficacy of 131I in patients of different clinical period, including different surgical ways (total or subtotal thyroidectomy along with half or double sides neck lymph node dissection), age ( 0.25, P < 0.005, P < 0.01). The effective rate was 91.67% (44) in 48 cases undergoing total thyroidectomy; the effective rate was 53.85% (21) in 39 patients undergoing subtotal thyroidectomy. There was a significant difference between the two groups above by χ2 test (χ2 = 16.291; P < 0.005). Conclusion: The efficacy of 131I ablation of stage I and stage III in postoperative PTC patients was almost alike, while the efficacy of stage IV descended markedly. The results was mainly determined by residual thyroid tissue size because of different surgical modus.

  19. Clinical Efficacy of Pulsed Radiofrequency Neuromodulation for Intractable Meralgia Paresthetica.

    Science.gov (United States)

    Lee, Jae Jun; Sohn, Jong Hee; Choi, Hyuk Jai; Yang, Jin Seo; Lee, Kwang Ho; Do, Hye Jin; Lee, Sung Ho; Cho, Yong Jun

    2016-03-01

    Meralgia paresthetica (MP) is a neurologic disorder of the lateral femoral cutaneous nerve (LFCN), which is characterized by a localized area of paresthesia and numbness on the anterolateral aspect of the thigh. In most patients with MP, symptoms can be successfully managed with conservative treatment. However, in a small group of MP patients who are refractory to medical treatment, more aggressive low-risk treatment should be considered. The objective of this study was to evaluate clinical outcomes of pulsed radiofrequency (PRF) neuromodulation of the LFCN in MP patients refractory to conservative treatment. Retrospective evaluation. We retrospectively reviewed the clinical data of 11 patients with medically intractable MP who underwent PRF neuromodulation of the LFCN. These patients with MP underwent a diagnostic LFCN block using 2.0% lidocaine. Temporary pain relief > 50% was considered to be a positive response to the diagnostic nerve block. Following a positive response to the diagnostic nerve block, patients underwent PRF neuromodulation at 42 degrees for 2 minutes. Patient pain was evaluated using a 10-cm visual analog scale (VAS). In MP patients who received PRF, we statistically evaluated VAS scores and the presence of any complications for 6 or more months after the procedure. The mean initial patient VAS score was 6.4 ± 0.97 cm. This score was decreased to 0.91 ± 0.70 cm, 0.82 ± 0.75 cm, and 0.63 ± 0.90 cm at the one-, 3-, and 6- month follow-ups, respectively (P < 0.001). Sixty-three point six percent of patients achieved complete pain relief (pain-free) in the last follow-up, whereas 27.3% of patients achieved successful pain relief (= 50% reduction in pain as determined by the VAS score). Furthermore, we did not observe any complications after the procedure. PRF neuromodulation of the LFCN provides immediate and long-lasting pain relief without complications. Therefore, PRF of the LCFN can be used as an alternative treatment in patients with MP

  20. Linagliptin: a thorough characterization beyond its clinical efficacy

    Directory of Open Access Journals (Sweden)

    Maria Angela eSortino

    2013-02-01

    Full Text Available Linagliptin, one of the five dipeptidyl peptidase-4 inhibitors available, has recently entered the market both in US and in most European countries for the treatment of type 2 diabetes mellitus. It presents a xanthine-based structure, and is characterized by unique pharmacokinetics, with non-linear profile, long terminal half-life allowing prolonged exposure to the drug. It is eliminated predominately through the intestinal tract and only minimally into urine, so that it can be administered, without any dose adjustment, in conditions of renal impairment. Linagliptin is effective in modifying all parameters of hyperglycemia either in monotherapy, or as add-on therapy, together with metformin or a sulphonylurea. It exhibits also a good tolerability profile with the appearance of few side effects, absence (when used in monotherapy or low risk (when in combination with a sulphonylurea of hypoglycemia. More importantly it has a neutral weight gain effect. A comprehensive report of the literature on linagliptin is provided, paying attention in particular to pre-clinical studies, interactions with other drugs, safety and tolerability and results obtained in animal models that highlight properties of linagliptin suggestive of potential additional uses. Particularly promising appear in fact data demonstrating a positive effect of linagliptin on metabolic dysfunction and renal and/or cardiovascular damage together with the more recently reported effects of linagliptin on tissue repair and neuroprotection.

  1. [Clinical efficacy and pharmacokinetics of cefpiramide in children].

    Science.gov (United States)

    Fujita, K; Sakata, H; Murono, K; Mukai, N; Yoshioka, H; Maruyama, S; Sanae, N; Tsuchida, A; Suzuki, Y

    1983-08-01

    Thirty-six febrile patients were administered cefpiramide (CPM) of 20 approximately 75 mg/kg/day for 3 approximately 11 days, and the clinical and side effects were evaluated. Among children with bacterial infections, including pneumonia, urinary tract infection, sepsis, pharyngitis and bronchitis, the results were excellent in 9, good in 13, and fair in 3 patients. Out of 36 patients, adverse reactions were observed in 9 cases, i.e. vascular pain at one shot intravenous injection in 4, diarrhea in 2, eosinophilia in 2, and diarrhea and eosinophilia in 1 case. One shot intravenous administration of CPM of 10 mg/kg to 4 patients yielded mean serum level of 100 micrograms/ml at 15 minutes and mean serum half-life of 2.5 hours, and administration of 20 mg/kg to 3 patients yielded mean serum level of 200 micrograms/ml at 15 minutes and mean serum half-life of 3.5 hours. The half-life in 1 patient with slight liver lesion was 5.36 hours. The rates of urinary recovery within 8 approximately 12 hours were 7.2 to 28.0% in 5 patients, 45.1% in a patient with nephrotic syndrome, and 50.9% in a patient with slight liver lesion.

  2. Hepatogenic Efficacy of Boerhaavia Diffusa (Punarnava on Clinical Cases of Liver Disorders in Dogs

    Directory of Open Access Journals (Sweden)

    Agrawal P

    2013-05-01

    Full Text Available The present study was aimed to investigate the hepatogenic efficacy of Boerhaavia diffusa (Punarnavaon clinical cases of liver disorders in dogs referred to Teaching Veterinary Clinical Service Complex(T.V.C.S.C. Polyclinic, Veterinary College, Jabalpur. Afore-mentioned treatment with Boerhaaviadiffusa showed hepatogenic activity causing altered histological changes returning to normalarchitecture of the liver. Hence Boerhaavia diffusa (punarnava may be used as a hepatogenic agent inclinical cases of liver disorders in dogs.

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

    Science.gov (United States)

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

    2013-01-01

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

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

    Science.gov (United States)

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

    2012-01-01

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

  5. The Relationship between Emotional Intelligence, Self-Efficacy, and Clinical Performance in Associate Degree Nursing Students

    Science.gov (United States)

    Rice, Eileen W.

    2013-01-01

    The purpose of this study was to explore self-efficacy, an individual's beliefs about his or her ability to perform a series of tasks, and emotional intelligence, an individual's ability to perceive, use, understand, and manage emotions, as predictors for successful clinical performance in nursing students. The participants were 49 female and 7…

  6. Pharmacokinetics and clinical efficacy of long-term epidural ropivacaine infusion in children

    DEFF Research Database (Denmark)

    Hansen, Tom Giedsing; Ilett, K F; Lim, S I;

    2000-01-01

    The clinical efficacy and pharmacokinetics of long-term epidural ropivacaine infusion were investigated in 18 postoperative children aged between 0.3 and 7.3 yr. A lumbar or thoracic epidural catheter was inserted after the anaesthetic induction. Sixty minutes following a bolus dose of ropivacaine...

  7. New medicinal products for chronic heart failure : Advances in clinical trial design and efficacy assessment

    NARCIS (Netherlands)

    Cowie, Martin R.; Filippatos, Gerasimos S.; Garcia, Maria de los Angeles Alonso; Anker, Stefan D.; Baczynska, Anna; Bloomfield, Daniel M.; Borentain, Maria; Slot, Karsten Bruins; Cronin, Maureen; Doevendans, Pieter A.; El-Gazayerly, Amany; Gimpelewicz, Claudio; Honarpour, Narimon; Janmohamed, Salim; Janssen, Heidi; Kim, Albert M.; Lautsch, Dominik; Laws, Ian; Lefkowitz, Martin; Lopez-Sendon, Jose; Lyon, Alexander R.; Malik, Fady I.; McMurray, John J. V.; Metra, Marco; Perez, Santiago Figueroa; Pfeffer, Marc A.; Pocock, Stuart J.; Ponikowski, Piotr; Prasad, Krishna; Richard-Lordereau, Isabelle; Roessig, Lothar; Rosano, Giuseppe M. C.; Sherman, Warren; Stough, Wendy Gattis; Swedberg, Karl; Tyl, Benoit; Zannad, Faiez; Boulton, Caroline; De Graeff, Pieter

    Despite the availability of a number of different classes of therapeutic agents with proven efficacy in heart failure, the clinical course of heart failure patients is characterized by a reduction in life expectancy, a progressive decline in health-related quality of life and functional status, as

  8. The Efficacy of the BCG Vaccine against Newly Emerging Clinical Strains of Mycobacterium tuberculosis.

    Directory of Open Access Journals (Sweden)

    Marcela Henao-Tamayo

    Full Text Available To date, most new vaccines against Mycobacterium tuberculosis, including new recombinant versions of the current BCG vaccine, have usually been screened against the laboratory strains H37Rv or Erdman. In this study we took advantage of our recent work in characterizing an increasingly large panel of newly emerging clinical isolates [from the United States or from the Western Cape region of South Africa], to determine to what extent vaccines would protect against these [mostly high virulence] strains. We show here that both BCG Pasteur and recombinant BCG Aeras-422 [used here as a good example of the new generation BCG vaccines] protected well in both mouse and guinea pig low dose aerosol infection models against the majority of clinical isolates tested. However, Aeras-422 was not effective in a long term survival assay compared to BCG Pasteur. Protection was very strongly expressed against all of the Western Cape strains tested, reinforcing our viewpoint that any attempt at boosting BCG would be very difficult to achieve statistically. This observation is discussed in the context of the growing argument made by others that the failure of a recent vaccine trial disqualifies the further use of animal models to predict vaccine efficacy. This viewpoint is in our opinion completely erroneous, and that it is the fitness of prevalent strains in the trial site area that is the centrally important factor, an issue that is not being addressed by the field.

  9. Clinical pharmacology and efficacy of sugammadex in the reversal of neuromuscular blockade.

    Science.gov (United States)

    Schaller, Stefan Josef; Lewald, Heidrun

    2016-09-01

    Sugammadex is the first clinical representative of a class of drugs called steroidal muscle relaxant encapsulators. Due to its 1:1 binding of rocuronium or vecuronium, sugammadex can reverse any depth of neuromuscular block and has therefore revolutionized the way anesthetists think about drug reversal. This review gives an overview of the clinical pharmacology and efficacy of sugammadex in healthy patients as well as in patients with pre-existing diseases. After approval in Europe in 2008 and Asia in 2010, sugammadex has recently been approved in the USA and Canada. This will open the field for further research especially for the use in special patient populations and specific diseases. Due to its pharmacodynamic profile, sugammadex in combination with rocuronium might have the potential to displace succinylcholine as the gold standard muscle relaxant for rapid sequence inductions. The use of rocuronium or vecuronium with the potential to reverse its action with sugammadex seems to be safe in patients with impaired neuromuscular transmission, i.e. (neuro)muscular diseases including myasthenia gravis. Data from long-term use of sugammadex is not yet available. Evidence towards an economic advantage of using sugammadex, justifying the relatively high costs for an anesthesia-related drug, is missing.

  10. [Clinical efficacy of subtalar joint arthrodesis with percutaneous opposite parallel cannulated screws].

    Science.gov (United States)

    Yuan, Cheng-song; Tang, Kang-lai; Chen, Cheng; Hu, Chao; Zhou, Bing-hua; Xu, Jian-zhong

    2013-06-04

    To explore the clinical efficacy of subtalar joint arthrodesis with percutaneous opposite parallel cannulated screws for severe subtalar joint arthritis. A total of 88 patients with 90 feet underwent subtalar joint fusion under four different incisions from April 2008 to April 2012. There were 56 males and 32 females with a mean age of 43.7 (15-74) years. All of them were evaluated by radiography or computed tomography (CT) scan and assessed by the rating scores of visual analog scale (VAS) and American Orthopedic Foot and Ankle Society (AOFAS). Among them, 68 cases were followed up for an average of 18.5 (6-48) months. Fusion was confirmed on radiography or CT in 67 cases with a fusion rate of 98.5%. The mean duration of fusion was 13.8 (6-28) weeks, the mean VAS score decreased from 6.00 to 1.03 points (P < 0.05) and the mean AOFAS score improved from 57.0 to 80.6 points (P < 0.05) with a good-and-excellent rate of 80.8%. Subtalar joint arthrodesis with percutaneous opposite parallel cannulated screws is recommend for severe subtalar joint arthritis. Such a procedure has a high fusion rate, excellent clinical outcomes and fewer complications.

  11. Safety and efficacy assessment of two new leprosy skin test antigens: randomized double blind clinical study.

    Directory of Open Access Journals (Sweden)

    Becky L Rivoire

    Full Text Available New tools are required for the diagnosis of pre-symptomatic leprosy towards further reduction of disease burden and its associated reactions. To address this need, two new skin test antigens were developed to assess safety and efficacy in human trials.A Phase I safety trial was first conducted in a non-endemic region for leprosy (U.S.A.. Healthy non-exposed subjects (n = 10 received three titrated doses (2.5 µg, 1.0 µg and 0.1 µg of MLSA-LAM (n = 5 or MLCwA (n = 5 and control antigens [Rees MLSA (1.0 µg and saline]. A randomized double blind Phase II safety and efficacy trial followed in an endemic region for leprosy (Nepal, but involved only the 1.0 µg (high dose and 0.1 µg (low dose of each antigen; Tuberculin PPD served as a control antigen. This Phase II safety and efficacy trial consisted of three Stages: Stage A and B studies were an expansion of Phase I involving 10 and 90 subjects respectively, and Stage C was then conducted in two parts (high dose and low dose, each enrolling 80 participants: 20 borderline lepromatous/lepromatous (BL/LL leprosy patients, 20 borderline tuberculoid/tuberculoid (BT/TT leprosy patients, 20 household contacts of leprosy patients (HC, and 20 tuberculosis (TB patients. The primary outcome measure for the skin test was delayed type hypersensitivity induration.In the small Phase I safety trial, reactions were primarily against the 2.5 µg dose of both antigens and Rees control antigen, which were then excluded from subsequent studies. In the Phase II, Stage A/B ramped-up safety study, 26% of subjects (13 of 50 showed induration against the high dose of each antigen, and 4% (2 of 50 reacted to the low dose of MLSA-LAM. Phase II, Stage C safety and initial efficacy trial showed that both antigens at the low dose exhibited low sensitivity at 20% and 25% in BT/TT leprosy patients, but high specificity at 100% and 95% compared to TB patients. The high dose of both antigens showed lower specificity (70% and 60

  12. Safety and Efficacy Assessment of Two New Leprosy Skin Test Antigens: Randomized Double Blind Clinical Study

    Science.gov (United States)

    Rivoire, Becky L.; Groathouse, Nathan A.; TerLouw, Stephen; Neupane, Kapil Dev; Ranjit, Chaman; Sapkota, Bishwa Raj; Khadge, Saraswoti; Kunwar, Chatra B.; Macdonald, Murdo; Hawksworth, Rachel; Thapa, Min B.; Hagge, Deanna A.; Tibbals, Melinda; Smith, Carol; Dube, Tina; She, Dewei; Wolff, Mark; Zhou, Eric; Makhene, Mamodikoe; Mason, Robin; Sizemore, Christine; Brennan, Patrick J.

    2014-01-01

    Background New tools are required for the diagnosis of pre-symptomatic leprosy towards further reduction of disease burden and its associated reactions. To address this need, two new skin test antigens were developed to assess safety and efficacy in human trials. Methods A Phase I safety trial was first conducted in a non-endemic region for leprosy (U.S.A.). Healthy non-exposed subjects (n = 10) received three titrated doses (2.5 µg, 1.0 µg and 0.1 µg) of MLSA-LAM (n = 5) or MLCwA (n = 5) and control antigens [Rees MLSA (1.0 µg) and saline]. A randomized double blind Phase II safety and efficacy trial followed in an endemic region for leprosy (Nepal), but involved only the 1.0 µg (high dose) and 0.1 µg (low dose) of each antigen; Tuberculin PPD served as a control antigen. This Phase II safety and efficacy trial consisted of three Stages: Stage A and B studies were an expansion of Phase I involving 10 and 90 subjects respectively, and Stage C was then conducted in two parts (high dose and low dose), each enrolling 80 participants: 20 borderline lepromatous/lepromatous (BL/LL) leprosy patients, 20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients, 20 household contacts of leprosy patients (HC), and 20 tuberculosis (TB) patients. The primary outcome measure for the skin test was delayed type hypersensitivity induration. Findings In the small Phase I safety trial, reactions were primarily against the 2.5 µg dose of both antigens and Rees control antigen, which were then excluded from subsequent studies. In the Phase II, Stage A/B ramped-up safety study, 26% of subjects (13 of 50) showed induration against the high dose of each antigen, and 4% (2 of 50) reacted to the low dose of MLSA-LAM. Phase II, Stage C safety and initial efficacy trial showed that both antigens at the low dose exhibited low sensitivity at 20% and 25% in BT/TT leprosy patients, but high specificity at 100% and 95% compared to TB patients. The high dose of both antigens

  13. CAG方案治疗中高危骨髓增生异常综合征和急性髓系白血病疗效观察%Clinical observation of the efficacy of CAG regimen for the treatment of intermediate or high risk myelodysplastic syndrome and acute myeloid leukemia

    Institute of Scientific and Technical Information of China (English)

    侯先锋; 刘琼; 苏贵珍; 孙海英

    2014-01-01

    Objective To observe the efficacy and adverse reactions of CAG regimen ( cytarabine and aclarubicin in combination with granulocyte colony -stimulating factor ) for treatment of intermediate or high risk myelodysplastic syn-drome (MDS) and acute myeloid leukemia (AML).Methods Twenty-eight MDS patients and twenty AML patients received CAG regimen .Then, the resulting efficacy was evaluated after one course of treatment , in which those with posi-tive response was given another course of treatment .Results MDS patients presented 53%of clinical effectiveness , in-cluding 15 cases (53%) with completely remission (CR).AML patients presented 65%of clinical effectiveness, inclu-ding 10 cases (50%) with CR and 3 cases (15%) with partial remission (PR).Most patients reported slight/mild ad-verse events, mainly myelosuppression , which was tolerable .Conclusion CAG regimen is safe and effective to treat in-termediate or high risk MDS and AML with poor prognosis , and its long-term efficacy requires further observation .%目的:观察阿糖胞苷、阿克拉霉素和粒细胞集落刺激因子联合方案( CAG方案)治疗中、高危骨髓增生异常综合征( MDS)和初治急性髓系白血病( AML)的临床疗效及不良反应。方法应用CAG方案治疗中高危MDS 28例和AML 20例,完成1个疗程后评估疗效,治疗失败患者退出观察,有效者继续接受1个疗程治疗,并进行评估。结果28例MDS临床总有效率53%,其中完全缓解15例(53%),部分缓解0例。 AML临床总有效13例(65%),其中完全缓解10例(50%),部分缓解3例(15%)。大部分患者出现了可以耐受的轻微不良反应,主要表现为骨髓抑制。结论 CAG治疗中、高危MDS和预后差的AML安全有效,长期疗效需进一步观察。

  14. What efficacy measures are clinically relevant and should be used in Cochrane Reviews of acute migraine trials?

    DEFF Research Database (Denmark)

    Tfelt-Hansen, Peer

    2015-01-01

    : The following EMs were used: pain free at two hours (30%), headache relief at two hours (60%), sustained pain free for 24 hours (19%) and sustained headache relief for 24 hours (39%). These EMs were also used in four other Cochrane reviews of acute migraine treatment. Of these EMs sustained headache relief...... for 24 h is not judged clinically relevant. CONCLUSION: Pain free and sustained pain free are clinically relevant, but the responses are rather low, demonstrating that there is a need for improvement of acute drug treatment in migraine.......BACKGROUND: Cochrane Reviews are methodologically of high quality but the clinical relevance of analysed efficacy measures (EMs) should also be assessed. METHODS: The clinical relevance of EMs used in one systematic Cochrane review of oral zolmitriptan for migraine headache was evaluated. RESULTS...

  15. Calcium phosphopeptides -- mechanisms of action and evidence for clinical efficacy.

    Science.gov (United States)

    Cochrane, N J; Reynolds, E C

    2012-09-01

    Phosphoproteins/phosphopeptides with clusters of acidic residues are found throughout nature, where they aid in the prevention of unwanted precipitation of solid calcium phosphates. The acidic residues, particularly phosphoserine, interact with calcium and stabilize clusters of calcium and phosphate. Saliva and milk are two examples of biological fluids that contain such phosphoprotein/phosphopeptide-stabilized calcium phosphates, and both share a similar evolutionary pathway. Saliva has been shown to have remineralization potential and is of critical importance in maintaining the mineral content of teeth in the oral environment. Milk can be enzymatically modified to release casein phosphopeptides that contain the clusters of residues that allow milk to stabilize high concentrations of calcium and phosphate. These casein phosphopeptide-stabilized amorphous calcium phosphate nanocomplexes (CPP-ACP) can stabilize even higher concentrations of calcium and phosphate than milk and can be considered a salivary biomimetic, since they share many similarities to statherin. The mechanisms of action and the growing body of scientific evidence that supports the use of CPP-ACP to augment fluoride in inhibiting demineralization and enhancing the remineralization of white-spot lesions are reviewed.

  16. Efficacy of surface disinfectant cleaners against emerging highly resistant gram-negative bacteria.

    Science.gov (United States)

    Reichel, Mirja; Schlicht, Anastasija; Ostermeyer, Christiane; Kampf, Günter

    2014-05-28

    Worldwide, the emergence of multidrug-resistant gram-negative bacteria is a clinical problem. Surface disinfectant cleaners (SDCs) that are effective against these bacteria are needed for use in high risk areas around patients and on multi-touch surfaces. We determined the efficacy of several SDCs against clinically relevant bacterial species with and without common types of multidrug resistance. Bacteria species used were ATCC strains; clinical isolates classified as antibiotic-susceptible; and multi-resistant clinical isolates from Klebsiella oxytoca, Klebsiella pneumoniae, and Serratia marcescens (all OXA-48 and KPC-2); Acinetobacter baumannii (OXA-23); Pseudomonas aeruginosa (VIM-1); and Achromobacter xylosoxidans (ATCC strain). Experiments were carried out according to EN 13727:2012 in quadruplicate under dirty conditions. The five evaluated SDCs were based on alcohol and an amphoteric substance (AAS), an oxygen-releaser (OR), surface-active substances (SAS), or surface-active-substances plus aldehydes (SASA; two formulations). Bactericidal concentrations of SDCs were determined at two different contact times. Efficacy was defined as a log10 ≥ 5 reduction in bacterial cell count. SDCs based on AAS, OR, and SAS were effective against all six species irrespective of the degree of multi-resistance. The SASA formulations were effective against the bacteria irrespective of degree of multi-resistance except for one of the four P. aeruginosa isolates (VIM-1). We found no general correlation between SDC efficacy and degree of antibiotic resistance. SDCs were generally effective against gram-negative bacteria with and without multidrug resistance. SDCs are therefore suitable for surface disinfection in the immediate proximity of patients. Single bacterial isolates, however, might have reduced susceptibility to selected biocidal agents.

  17. Pre-clinical properties of the α4β2 nicotinic acetylcholine receptor partial agonists varenicline, cytisine and dianicline translate to clinical efficacy for nicotine dependence

    Science.gov (United States)

    Rollema, H; Shrikhande, A; Ward, KM; Tingley, FD; Coe, JW; O'Neill, BT; Tseng, E; Wang, EQ; Mather, RJ; Hurst, RS; Williams, KE; de Vries, M; Cremers, T; Bertrand, S; Bertrand, D

    2010-01-01

    Background and purpose: Smoking cessation trials with three high-affinity partial agonists of α4β2 neuronal nicotinic acetylcholine receptors (nAChRs) have demonstrated differences in their clinical efficacy. This work examines the origin of the differences by taking into account brain exposure and pharmacological effects at human α4β2 nAChRs. Experimental approach: Rat plasma and brain pharmacokinetics were characterized and used to predict human steady-state plasma and brain concentrations following recommended doses of each of the three compounds. The pharmacological characterization included in vitro affinities at different nAChR subtypes, functional efficacies and potencies at the human α4β2 nAChR, as well as in vivo effects on rat mesolimbic dopamine turn-over. Key results: A comparison of predicted human brain concentrations following therapeutic doses demonstrated that varenicline and nicotine, but not dianicline and cytisine, can extensively desensitize and, to a lesser extent, activate α4β2 nAChRs. The limited clinical efficacy of dianicline may be accounted for by a combination of weak functional potency at α4β2 nAChRs and moderate brain penetration, while recommended doses of cytisine, despite its high in vitro potency, are predicted to result in brain concentrations that are insufficient to affect α4β2 nAChRs. Conclusions and implications: The data provide a plausible explanation for the higher abstinence rate in smoking cessation trials following treatment with varenicline than with the two other α4β2 nAChR partial agonists. In addition, this retrospective analysis demonstrates the usefulness of combining in vitro and in vivo parameters with estimated therapeutic human brain concentrations for translation to clinical efficacy. PMID:20331614

  18. EFFICACY OF FIXED COMBINATION OF VALSARTAN, AMLODIPINE AND HYDROCHLOROTHIAZIDE IN COMPLEX THERAPY OF THE PATIENT OF VERY HIGH CARDIOVASCULAR RISK

    Directory of Open Access Journals (Sweden)

    I. M. Sokolov

    2012-01-01

    Full Text Available The high prevalence of arterial hypertension in association with high and very high cardiovascular risk requires widespread use of combined therapy. Current approaches to selection of combination components of antihypertensive drugs are based the efficacy of these drugs proven in multicenter randomized clinical trials. The triple combination of calcium antagonist, angiotensin II receptor blocker and thiazide diuretic is regarded as the best option for combined therapy in patients with arterial hypertension and ischemic heart disease to reduce cardiovascular risk.

  19. Sources of Writing Self-Efficacy Beliefs of Elementary, Middle, and High School Students

    Science.gov (United States)

    Pajares, Frank; Johnson, Margaret J.; Usher, Ellen L.

    2007-01-01

    The purpose of this study was to examine the influence of Albert Bandura's four hypothesized sources of self-efficacy on students' writing self-efficacy beliefs (N = 1256) and to explore how these sources differ as a function of gender and academic level (elementary, middle, high). Consistent with the tenets of self-efficacy theory, each of the…

  20. Clinical efficacy of dressings for treatment of heavily exuding chronic wounds

    Directory of Open Access Journals (Sweden)

    Wieg

    2015-06-01

    Full Text Available Cornelia Wiegand, Jörg Tittelbach, Uta-Christina Hipler, Peter Elsner Department of Dermatology, University Hospital Jena, Jena, Germany Abstract: The treatment of chronic ulcers is a complex issue and presents an increasing problem for caregivers everywhere. This is especially true in Germany, where more than 4 million chronic wounds are treated each year. Therapeutic decisions must be patient-centered and reflect wound etiology, localization, and healing status. The practice of using the same wound dressing during the entire healing period is no longer reasonable. Instead, multiple types of dressings may be needed for a single wound over its healing trajectory. Selection of the most appropriate dressing should be based on wound phase, depth, signs of infection, and level of exudate. Moisture balance is critical in wound care; dryness will hamper epithelial cell migration while excessive generation of fluid causes maceration at the wound margins. Hence, exudate management is a key issue in chronic wound therapy, particularly given that exudate from chronic wounds has a composition different from that of acute wound fluid. Several studies have shown that exudates from non-healing wounds contain significantly elevated levels of protease activity, increased formation of free radicals, and abundant amounts of proinflammatory cytokines, while concentrations of growth factors and protease inhibitors are markedly decreased. Application of dressings that remove and sequester excess amounts of wound fluid may not only help in restoring the correct balance of moisture, but also support the wound healing process by preventing tissue deterioration caused by abundant protease activity. Several types of dressings, such as hydrogels, hydrocolloids, alginates, hydrofibers, foams, and superabsorbent dressings, are reviewed here and evaluated with regard to their efficacy for highly exuding wounds. Keywords: chronic wounds, exuding, dressings, clinical efficacy 

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

    DEFF Research Database (Denmark)

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

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

  2. Clinical efficacy of Toric intraocular lens implantation for cataract patients with corneal astigmatism

    Directory of Open Access Journals (Sweden)

    Guo-Hua Deng

    2015-11-01

    Full Text Available AIM: To investigate the clinical efficacy of Toric intraocular lens(IOLimplantation for cataract patients with corneal astigmatism.METHODS: Thirty-eight patients(46 eyeswith corneal astigmatism undergone phacoemulsification and IOL implantation in our hospital from June 2013 to July 2014 were observed. Twenty cases(24 eyesreceived Toric IOL, 18 cases(22 eyesgot Acrysof IQ IOL. The clinical efficacy of the two groups was analyzed.RESULTS:The difference on visual acuity after surgery between the two groups was statistically significant(F=5.783, PPt=5.248, 2.573, 2.782; all PF=5.482, PPt=6.591, 3.287, 2.167; all PCONCLUSION: Phacoemulsification associated with Toric IOL implantation has good correction effect and prediction for cataract and corneal astigmatism patients, and can improve the visual activity significantly, so it is worthy of clinical application.

  3. Perceived sources and levels of stress, general self-efficacy and coping strategies in clinical dental students.

    Science.gov (United States)

    Ersan, Nilüfer; Fişekçioğlu, Erdoğan; Dölekoğlu, Semanur; Oktay, İnci; İlgüy, Dilhan

    2017-02-06

    The aims of this study were to identify sources of stress among clinical students and to evaluate the students' perceived levels of stress, general self-efficacy and effective coping strategies in a private dental school environment. The study group consisted of 130 undergraduate clinical dental students in a Turkish private dental school, during the academic year 2014-2015. The students were surveyed using modified version of the dental environment stress (DES) survey, the perceived stress scale, the general self-efficacy scale (G-SES) and the brief coping scale. Age, sex, year of study, history of psychiatric treatment and factors that affected the choice of dentistry were also recorded. Final year and female clinical dental students, who were found to be the most stressful students, had moderate to high perceived stress scores. Total and 'Faculty and administration' related DES scores increased with the year of study. Stressors related to 'Workload' and 'Clinical training' affected females more than males. G-SES scores were higher in male students and students, who had no history of psychiatric treatment. The most and the least common coping strategies were 'Planning' and 'Substance abuse', respectively. 'Religion' was found to be one of the main coping strategies. Stress factors affecting Turkish clinical dental students studying at private dental school differed from the previously reported stress factors affecting students studying at a governmental dental school. Advanced year and female students experienced more stress than the other students.

  4. A highly efficacious pediculicide based on dimeticone: Randomized observer blinded comparative trial

    Directory of Open Access Journals (Sweden)

    Oliveira Fabíola A

    2008-09-01

    Full Text Available Abstract Background Infestation with the human head louse (Pediculus humanus capitis occurs worldwide. Existing treatment options are limited, and reports of resistance to commonly used pediculicides have been increasing. In this trial we assessed the efficacy of a product containing a high (92% concentration of the silicone oil dimeticone (identical in composition to NYDA®, as compared to a 1% permethrin lotion. Methods Randomized, controlled, observer blinded clinical trial. Participants were recruited from a poor urban neighbourhood in Brazil where pediculosis capitis was highly prevalent. To minimize reinfestation during the trial, participants (145 children aged 5–15 years with head lice infestations were transferred to a holiday resort outside the endemic area for a period of 9 days. Two applications of dimeticone or 1% permethrin were done, seven days apart. Outcome measures were defined as cure (absence of vital head lice after first application and before and after second applications, degree of itching, cosmetic acceptability, and clinical pathology. Results Overall cure rates were: day 2 – dimeticone 94.5% (95% CI: 86.6% – 98.5% and permethrin 66.7% (95% CI: 54.6% – 77.3%; p Conclusion The dimeticone product is a safe and highly efficacious pediculicide. Due to its physical mode of action (interruption of the lice's oxygen supply of the central nervous system, development of resistance is unlikely. Trial registration Current Controlled Trials ISRCTN15117709.

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

    Directory of Open Access Journals (Sweden)

    Jung Wan Han

    2015-01-01

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

  6. Clinical efficacy and safety in relapsed/refractory mantle cell lymphoma: a systematic literature review.

    Science.gov (United States)

    Njue, Annete; Colosia, Ann; Trask, Peter C; Olivares, Robert; Khan, Shahnaz; Abbe, Adeline; Police, Rachel; Wang, Jianmin; Ruiz-Soto, Rodrigo; Kaye, James A; Awan, Farrukh

    2015-01-01

    A systematic literature review was performed to collect and review information on the clinical efficacy and safety of treatments for relapsed/refractory (R/R) mantle cell lymphoma (MCL), with a meta-analysis, if possible. PubMed, Embase, and the Cochrane Library were searched for studies published in English from January 1, 1997, to August 2, 2012. Conference proceedings, bibliographic reference lists of included articles, recent reviews, and ClinicalTrials.gov were searched for phase II to IV studies displaying results. Studies were included if they reported on patients with R/R MCL who were ineligible to receive high-dose chemotherapy with stem cell transplant. Studies of patients with several non-Hodgkin lymphoma subtypes were only included if they reported MCL outcomes separately. We identified 59 studies in R/R MCL. Forty distinct treatment regimens were evaluated. Thirty studies included more than 15 patients with R/R MCL. Six studies were comparative (including 5 randomized controlled trials [RCTs]); 53 were single-arm. There were no common treatments among the RCTs; therefore, a meta-analysis was not feasible. Thirty-one of 59 studies reported baseline data for patients with R/R MCL. Of the 30 studies with > 15 patients with R/R MCL, 30 reported overall response rate data, 14 reported progression-free survival (PFS), and 12 reported overall survival (OS). The small number of RCTs in R/R MCL precludes identifying an optimal treatment. Small sample sizes, infrequent reporting of OS and PFS, and limited information on patient characteristics made a comparison of results difficult. High-quality comparative studies of novel therapies that have the potential to demonstrate OS advantages in R/R MCL are needed.

  7. Theory-based analysis of clinical efficacy of triptans using receptor occupancy

    Science.gov (United States)

    2014-01-01

    Background Triptans, serotonin 5-HT1B/1D receptor agonists, exert their action by targeting serotonin 5-HT1B/1D receptors, are used for treatment of migraine attack. Presently, 5 different triptans, namely sumatriptan, zolmitriptan, eletriptan, rizatriptan, and naratriptan, are marketed in Japan. In the present study, we retrospectively analyzed the relationships of clinical efficacy (headache relief) in Japanese and 5-HT1B/1D receptor occupancy (Φ1B and Φ1D). Receptor occupancies were calculated from both the pharmacokinetic and pharmacodynamic data of triptans. Methods To evaluate the total amount of exposure to drug, we calculated the area under the plasma concentration-time curve (AUCcp) and the areas under the time curves for Ф1B and Ф1D (AUCФ1B and AUCФ1D). Moreover, parameters expressing drug transfer and binding rates (A cp , A Ф 1B , A Ф 1D ) were calculated. Results Our calculations showed that Фmax1B and Фmax1D were relatively high at 32.0-89.4% and 68.4-96.2%, respectively, suggesting that it is likely that a high occupancy is necessary to attain the clinical effect. In addition, the relationships between therapeutic effect and AUCcp, AUCΦ1B, AUCΦ1D, and A cp  · AUCcp differed with each drug and administered form, whereas a significant relationship was found between the therapeutic effect and A Φ 1B  · AUCΦ1B or A Φ 1D  · AUCΦ1D that was not affected by the drug and the form of administration. Conclusions These results suggest that receptor occupancy can be used as a parameter for a common index to evaluate the therapeutic effect. We considered that the present findings provide useful information to support the proper use of triptans. PMID:25488888

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

    DEFF Research Database (Denmark)

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

    2013-01-01

    Background: Interprofessional collaboration potentially enhances patient safety and satisfaction, and reduces tensions and conflicts among health professionals. However, health professionals often lack sufficient knowledge of other professional roles and competences to engage in interprofessional...... teamwork. The aim of this study was to assess the impact of an interprofessional training programme on students' perceived self-efficacy. Methods: A quasi-experimental study with an intervention group (239 students) and a control group (405 students). The intervention was an interprofessional clinical...... study (ICS) unit including students from nursing, medicine, physiotherapy, occupational therapy, laboratory technology and radiography. Data on students' perceived self-efficacy were collected through web-based questionnaires. Aspects of self-efficacy measured were: (1) collaboration with other...

  9. Clinical research and diagnostic efficacy studies in the oral and maxillofacial radiology literature: 1996–2005

    Science.gov (United States)

    Kim, IH; Patel, MJ; Hirt, SL; Kantor, ML

    2011-01-01

    Objectives The aim of this study was to determine the level of evidence that is published in the oral and maxillofacial radiology (OMR) literature. Methods OMR papers published in Dentomaxillofacial Radiology and Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology and Endodontology between 1996 and 2005 were classified using epidemiological study design and diagnostic efficacy hierarchies. The country of origin and number of authors were noted. Results Of the 725 articles, 384 could be classified with the epidemiological study design hierarchy: 155 (40%) case reports/series and 207 (54%) cross-sectional studies. The distribution of study designs was not statistically significant across time (Fisher's exact test, P = 0.06) or regions (P = 0.89). The diagnostic efficacy hierarchy was applicable to 246 articles: 71 (29%) technical efficacy and 166 (67%) diagnostic accuracy studies. The distribution of efficacy levels was not statistically significant across time (P = 0.22) but was significant across regions (P < 0.01). Authors from Japan produced 26% of the papers with a mean ± standard deviation of 5.78 ± 1.98 authors per paper (APP); American authors, 23% (3.78 ± 1.72 APP); and all others, 51% (3.76 ± 1.51 APP). Conclusion The OMR literature consisted mostly of case reports/series, cross-sectional, technical efficacy and diagnostic accuracy studies. Such studies do not provide strong evidence for clinical decision making nor do they address the impact of diagnostic imaging on patient care. More studies at the higher end of the study design and efficacy hierarchies are needed in order to make wise choices regarding clinical decisions and resource allocations. PMID:21697152

  10. Clinical efficacy and safety of olmesartan/hydrochlorothiazide combination therapy in patients with essential hypertension

    Directory of Open Access Journals (Sweden)

    Luis M Ruilope

    2008-12-01

    Full Text Available Luis M RuilopeUnidad de Hipertensión, Hospital 12 de Octubre, Madrid, SpainAbstract: Hypertension is a major risk factor for cardiovascular disease that contributes to the premature death of millions of people each year, and identification and treatment of hypertension continues to be a challenge. Guidelines recommend that many patients will require two or more antihypertensive agents from different classes. Combining an angiotensin II receptor blocker (ARB with hydrochlorothiazide (HCTZ has been shown in clinical studies to increase the antihypertensive efficacy of both agents compared with either agent alone. This review covers several clinical trials and aims to examine several aspects of the efficacy of the combination of olmesartan and HCTZ, including dose-responsiveness, long-term efficacy, goal rate achievement, and efficacy in patients with moderate to severe hypertension. The results presented here demonstrate that olmesartan is effective when added to HCTZ monotherapy or when HCTZ is added to olmesartan monotherapy, both over the short and long term. Moderate to severe hypertension responds well to olmesartan/HCTZ combination therapy, and the great majority of patients are able to achieve recommended blood pressure targets. Thus olmesartan/HCTZ is a well-tolerated option for patients who fail to respond to monotherapy and as initial therapy in those who require large reductions in diastolic blood pressure or systolic blood pressure to achieve goal blood pressure.Keywords: hypertension, olmesartan medoxomil; hydrochlorothiazide, angiotensin II receptor blocker, thiazide diuretic

  11. Clinical efficacy and safety of olmesartan/hydrochlorothiazide combination therapy in patients with essential hypertension

    Science.gov (United States)

    Ruilope, Luis M

    2008-01-01

    Hypertension is a major risk factor for cardiovascular disease that contributes to the premature death of millions of people each year, and identification and treatment of hypertension continues to be a challenge. Guidelines recommend that many patients will require two or more antihypertensive agents from different classes. Combining an angiotensin II receptor blocker (ARB) with hydrochlorothiazide (HCTZ) has been shown in clinical studies to increase the antihypertensive efficacy of both agents compared with either agent alone. This review covers several clinical trials and aims to examine several aspects of the efficacy of the combination of olmesartan and HCTZ, including dose-responsiveness, long-term efficacy, goal rate achievement, and efficacy in patients with moderate to severe hypertension. The results presented here demonstrate that olmesartan is effective when added to HCTZ monotherapy or when HCTZ is added to olmesartan monotherapy, both over the short and long term. Moderate to severe hypertension responds well to olmesartan/HCTZ combination therapy, and the great majority of patients are able to achieve recommended blood pressure targets. Thus olmesartan/HCTZ is a well-tolerated option for patients who fail to respond to monotherapy and as initial therapy in those who require large reductions in diastolic blood pressure or systolic blood pressure to achieve goal blood pressure. PMID:19337537

  12. Efficacy of flavonoids in the management of high blood pressure.

    Science.gov (United States)

    Clark, Jaime L; Zahradka, Peter; Taylor, Carla G

    2015-12-01

    Plant compounds such as flavonoids have been reported to exert beneficial effects in cardiovascular disease, including hypertension. Information on the effects of isolated individual flavonoids for management of high blood pressure, however, is more limited. This review is focused on the flavonoids, as isolated outside of the food matrix, from the 5 main subgroups consumed in the Western diet (flavones, flavonols, flavanones, flavan-3-ols, and anthocyanins), along with their effects on hypertension, including the potential mechanisms for regulating blood pressure. Flavonoids from all 5 subgroups have been shown to attenuate a rise in or to reduce blood pressure during several pathological conditions (hypertension, metabolic syndrome, and diabetes mellitus). Flavones, flavonols, flavanones, and flavanols were able to modulate blood pressure by restoring endothelial function, either directly, by affecting nitric oxide levels, or indirectly, through other pathways. Quercetin had the most consistent blood pressure-lowering effect in animal and human studies, irrespective of dose, duration, or disease status. However, further research on the safety and efficacy of the flavonoids is required before any of them can be used by humans, presumably in supplement form, at the doses required for therapeutic benefit.

  13. Clinical efficacy and safety of topical versus oral ivermectin in treatment of uncomplicated scabies.

    Science.gov (United States)

    Ahmad, Hesham M; Abdel-Azim, Eman S; Abdel-Aziz, Rasha T

    2016-01-01

    Many medications are available for scabies treatment including oral and topical ivermectin. However, studies comparing these two forms as a scabies treatment are few. This study compares efficacy and safety of topical versus oral ivermectin as scabies treatment. The study included 62 confirmed uncomplicated scabies patients, divided into: Group I (32 patients, received topical ivermectin) and Group II (30 patients, received oral ivermectin). Patients were assessed, clinically and by KOH smear at 1, 2 and 4 weeks. Treatment was repeated after one week in patients with persistent infection. Adverse events were recorded. Most patients (87.5% and 73.5% in group I and group II respectively) were symptom free after a single treatment. A second treatment was required in 4 patients of group I and 8 patients of group II. However, 2 weeks after treatment symptoms and signs completely resolved in all cases with no recurrence at 4 weeks. This study suggests that both topical and oral ivermectin are safe and equally effective in treatment of uncomplicated scabies. Single treatment, whether topical or oral, is associated with high cure rate in a week post treatment. However, repeating treatment after one week may be required to achieve 100% cure.

  14. Study on docetaxel-loaded nanoparticles with high antitumor efficacy against malignant melanoma

    Institute of Scientific and Technical Information of China (English)

    Donghui Zheng; Xiaolin Li; Huae Xu; Xiaowei Lu; Yong Hu; Weixin Fan

    2009-01-01

    Docetaxel (Doc) has extraordinary activities against a variety of solid tumors.However,the clinical efficacy of Doc is limited due to its poor solubility,low selective dis-tribution,fast elimination in vivo,etc.In the present study,Doc was incorporated into the core-shell structure of nanoparticles prepared based on our previous work.The obtained docetaxel-loaded nanoparticles (DOCNP) were characterized with various biophysical method-ologies,and its antitumor efficacy against malignant mel-anoma was evaluated both in vitro and in vivo.Our results indicated that Doc could be incorporated into the nanoparticles with high encapsulation efficiency (>90%).The incorporated Doc can be released from DOCNP in a sustained manner.In vitro cytotoxicity studies indicated that DOCNP could effectively kill B16 cells and show a dose- and time-dependent efficacy.Furthermore,intratu-moral administration revealed that DOCNP has signifi-cantly higher antitumor effect and lower toxicity to normal cells and tissues than free Doc.These results suggest that DOCNP may be a promising drug delivery system in therapy for malignant melanoma.

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

    DEFF Research Database (Denmark)

    Zarchi, K.; Jemec, G.B.

    2012-01-01

    Over the last decade, maggot debridement therapy (MDT) has been recognized by many clinicians as a potential adjunct to conventional therapy, and many patients with non healing, chronic ulcers have been treated. Numerous case reports and case series have described the successful use of MDT...... in a variety of ulcers. However, comparative clinical trials and in particular randomized controlled trials investigating the efficacy of MDT are sparse. A systematic search in the literature showed three randomized clinical trials and five non randomized studies evaluating the efficacy of sterile Lucilia...... sericata applied on ulcers with various aetiologies. Of these, seven studies had debridement and/or healing as an outcome variable. When evaluating maggots as debriding agents, the studies report MDT as being significantly more effective than hydrogel or a mixture of conventional therapy modalities...

  16. Effect of Compound Sulfadiazine Suspension on Growth Performance of Broiler in Clinical Efficacy Trial

    Directory of Open Access Journals (Sweden)

    Leilei Wang

    2014-04-01

    Full Text Available Compound Sulfadiazine suspension is used mainly to prevent and cure E. coli, Salmonella infection of chicken in veterinary clinical application. Effect of compound Sulfadiazine suspension on growth performance of broiler in clinical efficacy trial was studied in the study. One hundred eighty 15-day-old broilers were divided randomly into six groups, blank control group, negative control group, Trisulmixos gavage group, Trisulmixos drinking group, Sufuning gavage group and Sufuning drinking group, respectively. There were three repeating treatments in each group and ten broilers in each treatment. Results showed that compound Sulfadiazine suspension can promote the feed conversion rate of broiler when curing E. coli, Salmonella infection of chicken. Both from the perspective of efficacy and from the perspective of growth performance, giving drug by gavage were more effective than giving by drinking. When two products of Compound Sulfadiazine suspension were compared, the indicators of Sufuning were a little better Trisulmixos.

  17. Clinical efficacy of eribulin mesylate for the treatment of metastatic soft tissue sarcoma.

    Science.gov (United States)

    Emambux, Sheik; Italiano, Antoine

    2017-06-01

    Metastatic soft tissue sarcoma, a devastating disease, has a median overall survival of only 12-18 months. Treatment options remain scarce. However, eribulin mesylate, a first-in-class halichondrin B-based microtubule dynamics inhibitor, has recently been approved for the management of patients with advanced liposarcoma. Areas covered: Based on a review of the literature between 2005 and 2017, we present a summary of eribulin mesylate's mechanism of action and the studies showing its clinical efficacy in locally advanced or metastatic sarcomas. Expert commentary: Future development includes the definition of a biomarker signature related to patient outcome with eribulin. Further investigation via controlled clinical trials is needed to identify combination regimens that can optimize the efficacy of eribulin while providing an acceptable safety profile in sarcoma patients.

  18. HIGH SCHOOL STUDENTS' COGNITIVE FLEXIBILITY IS PREDICTED BY SELF-EFFICACY AND ACHIEVEMENT

    OpenAIRE

    Binnaz Kiran Esen; H. Duygu Özcan; Mehtap Sezgin

    2017-01-01

    In this research, the prediction cognitive flexibility obtained by general self-efficacy, academic self-efficacy, social self-efficacy, emotional self-efficacy and achievement is examined. This study is executed in 2014- 2015 academic year on 760 high school students who are between ages 15 and 18. Cognitive flexibility Scale is developed by Bilgin (2009b) is used for defining cognitive flexibility, Self-Efficacy Scale is developed by Çelikkaleli, Gündoğdu ve Kıran-Esen (2006) is used for def...

  19. CLINICAL EFFICACY OF THE ROBOT-ASSISTED LAPAROSCOPIC MYOMECTOMY (A REVIEW OF THE LITERATURE

    Directory of Open Access Journals (Sweden)

    V. A. Gudebskaya

    2016-01-01

    Full Text Available Rationale: One of the most complicated and unresolved problems in clinical medicine is the choice of an optimal method for organ-preservation treatment of uterine fibroids in women of childbearing age. Aim: To assess clinical efficacy of robot-assisted laparoscopic myomectomy. Materials and methods: The search was performed in PubMed, Embase, Trip, Cochrane, DocMe databases by keywords: “fibroids”, “robot”, “da Vinci”, “robotic myomectomy”, “robot-assisted myomectomy”. Results: We found 25 publications on robot-assisted laparoscopic myomectomy, including 6  papers on its reproductive outcomes (levels of evidence II–IV. Duration of robot-assisted surgery ranged from 132 to 261 minutes, intraoperative blood loss was in the range from 50 to 387 mL, postoperative hospital stay ranged from 1 to  3.9  days. There was a  lower percentage of intra- and postoperative complications after the robot-assisted interventions, compared to abdominal or classic laparoscopic access, as well as a lower percentage of conversion laparotomies compared to laparoscopy. Pregnancy rates after robotic myomectomy ranged from 16.7 to 69%. Only one case of uterine rupture after robot-assisted laparoscopic myomectomy has been described in the literature. Conclusion: Due to high cost of the method, the number of conducted studies is insufficient to evaluate the role of robotic technologies in the organ-preservation approach to uterine fibroids. Nevertheless, they suggest that robot-assisted laparoscopic myomectomy is justified in women of childbearing age who are planning pregnancy, with big centripetally growing intramural nodes and deformation of the uterine cavity. This technique on its own is an independent method for fertility restoration and could be the first step before the use of assisted reproductive technology.

  20. [Pharmaceutical analysis and clinical efficacy of Kampo medicine, maoto, extract suppository against pediatric febrile symptoms].

    Science.gov (United States)

    Nishimura, Nobuhiro; Doi, Norio; Uemura, Tomochika; Taketani, Takeshi; Hayashi, George; Kasai, Takeshi; Kanai, Rie; Yamaguchi, Seiji; Iwamoto, Kikuo; Naora, Kohji

    2009-06-01

    A traditional Chinese herbal medicine, Kampo medicine, maoto, has been widely used in the treatment of febrile symptoms caused by viral infection. This herbal extract granule for oral use, however, is not well accepted by infants or young children due to its unpleasant taste and odor. Therefore, we prepared Kampo medicine, maoto, suppository and investigated the pharmaceutical and clinical efficacy of the suppository. Kampo medicine, maoto, granules were micro-pulverized and homogeneously dispersed into Hosco-H15 to prepare suppositories containing 0.25 to 1.0 g herbal extract by the conventional fusion method. Content of l-ephedrine, an index compound of Kampo medicine, maoto, in the extract granules and suppositories was determined by using a high performance liquid chromatographic method. Physicochemical experiments revealed that the suppository containing 0.5 g herbal extract had the most suitable melting point of 34 degrees C. Contents of l-ephedrine in the suppository were constant, 93-96% of those in the same amount of the extract granules in different three lots. Upper and lower portions of the suppository had the same content of l-ephedrine. The suppository maintained more than 95% of l-ephedrine content through 6 months at 4 degrees C, room temperature and 40 degrees C, although maldistribution of the extract constituent was observed after storage at 40 degrees C. The suppository was administered to 21 pediatric febrile patients at a dose of 1/3 to 2 full pieces depending on their body weight and physical status. Significant reduction (psuppository was found to satisfy the physicochemical quality and quantity standards as well as to be clinically applicable to neonates, infants and children with viral febrile symptoms without any adverse effects.

  1. Immediate and long-term efficacy and safety of photodynamic therapy with Photolon (Fotolon): a seven-year clinical experience

    Science.gov (United States)

    Istomin, Yuri P.; Kaplan, Michael A.; Shliakhtsin, Siarhei V.; Lapzevich, Tatsiana P.; Cerkovsky, Dmitriy A.; Marchanka, Ludmila N.; Fedulov, Alexander S.; Trukhachova, Tatsiana V.

    2009-06-01

    The purpose of the present study was to summarize data on the long-term efficacy of photodynamic therapy (PDT) with Photolon in patients with malignant tumors of various types and localizations. The data obtained show that PDT with Photolon is a highly effective therapeutic modality for the treatment of skin tumors, cervical intraepithelial neoplasias, lung cancers, disseminated forms of melanoma, primary and metastatic brain tumors, several ophthalmologic diseases. This paper provides a review of most illustrative studies of the application of PDT with Photolon for the treatment of different oncological and non-oncological diseases performed in leading clinical centers of the Republic of Belarus and Russia.

  2. 内镜下HFEC术对比APC术治疗大肠息肉的疗效探究%Clinical efficacy of endoscopic high frequency electric coagulation and argon plasma coagulation for colorectal polyps

    Institute of Scientific and Technical Information of China (English)

    刘伟

    2015-01-01

    目的 探究内镜下高频电凝切除术(High frequency electric coagulation,HFEC)与氩离子凝固术(Argon plasma coagulation,APC)在大肠息肉(Colorectal polyps,CP)治疗中的价值,为临床上CP治疗方式的选择提供依据.方法选择2009年3月-2014年3月在杭州师范大学附属医院接受治疗的CP患者980例,随机分成HFEC组490例(息肉653枚)和APC组490例(息肉688枚),HFEC组患者采用HFEC切除治疗,APC组则采用APC术治疗.治疗后,统计2组患者一次清除率和并发症发生率,据此评价两种术式对CP治疗的价值.结果采用SPSS19.0进行统计学分析,行x2检验,以P<0.05为差异具有统计学意义.结果 APC组一次切除息肉635枚,两次及以上切除53枚,一次切除率为92.3%,而HFEC组一次切除息肉562枚,两次及以上切除91枚,一次切除率为86.1%,2组一次切除率比较,差异具有统计学意义(x2 =13.58,P<0.05);APC组发生腹胀22例,腹痛13例,穿孔1例,出血2例,并发症率为7.8%;HFEC组发生腹胀34例,腹痛21例,穿孔6例,出血9例,并发症率为14.3%,2组并发症率比较,差异具有统计学意义(x2=10.66,P<0.05).结论 APC术治疗CP一次切除率高,且并发症低,安全可靠,是CP患者较佳的治疗方式.

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

    Science.gov (United States)

    Dybowski, Christoph; Sehner, Susanne; Harendza, Sigrid

    2017-05-08

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

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

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    Jaiberth Antonio Cardona-Arias

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

  5. Academic self-efficacy for high school scale: search for psychometrics evidence

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    Soely Polydoro

    2015-05-01

    Full Text Available This article aims to present the adaptation and the search for psychometrics evidence of an academic self-efficacy scale. High school students (N = 453 participated of the research (mean age 15.93; SD 1.2. The Academic Self-efficacy Scale for High School is an adapted scale composed of 16 items and organized into three factors: self-efficacy for learning, self-efficacy to act in school life, and self-efficacy for the career decision. Through exploratory factor analysis, a KMO = 0.90 was verified, and 56.57% of the variance was explained. The internal consistency was 0.88. The scale demonstrated good conditions to identify academic self-efficacy of high school students.

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

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    Peter Joseph Jongen

    2015-01-01

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

  7. Clinical trials of artesunate plus sulfadoxine-pyrimethamine for Plasmodium falciparum malaria in Afghanistan: maintained efficacy a decade after introduction.

    Science.gov (United States)

    Awab, Ghulam Rahim; Imwong, Mallika; Pukrittayakamee, Sasithon; Alim, Fazel; Hanpithakpong, Warunee; Tarning, Joel; Dondorp, Arjen M; Day, Nicholas P J; White, Nicholas J; Woodrow, Charles J

    2016-02-25

    Combination therapy with artesunate plus sulfadoxine-pyrimethamine (SP) was adopted as recommended treatment for Plasmodium falciparum infection in Afghanistan in 2003. A series of prospective clinical studies examining the efficacy of artesunate plus sulfadoxine-pyrimethamine (AS + SP) against P. falciparum were undertaken in sentinel sites in Afghanistan from 2007 to 2014, accompanied by relevant molecular studies. The first study was a randomized trial of AS + SP versus dihydroartemisinin-piperaquine, while two subsequent studies were standard therapeutic efficacy studies of AS + SP. Three hundred and three patients were enrolled across four provinces in the north and east of the country. Curative efficacy was high in all the trials, with an adequate clinical and parasitological response (ACPR) of more than 95 % in all groups and trial stages. Genotyping for drug-resistance alleles at dhfr indicated fixation of the S108 N mutation and a prevalence of the C59R mutation of approximately 95 % across all sites. Other mutations in dhfr and dhps remained rare or absent entirely, although five isolates from the first trial carried the dhps triple mutant SGEGA haplotype. In the last study undertaken in 2012-2014 the K13 artemisinin resistance marker was examined; only two of 60 successfully sequenced samples carried a K13-propeller mutation. These data confirm maintained efficacy 10 years after introduction of artesunate plus SP as combination treatment of P. falciparum in Afghanistan. The molecular data indicate that despite a substantial fall in incidence, resistance has not developed to artemisinins, or intensified to the ACT partner drug components. Trial Registration http://www.clinicaltrials.gov/ct NCT00682578, NCT01115439 and NCT01707199.

  8. Efficacy and safety of once daily low molecular weight heparin (tinzaparin sodium) in high risk pregnancy.

    LENUS (Irish Health Repository)

    Ní Ainle, Fionnuala

    2008-10-01

    Low molecular weight heparin (LMWH) is widely regarded as the anticoagulant treatment of choice for the prevention and treatment of venous thromboembolism during pregnancy. However, previous studies have demonstrated that the pharmacokinetic profiles of LMWH vary significantly with increasing gestation. Consequently, it remains unclear whether LMWH regimens recommended for use in nonpregnant individuals can be safely extrapolated to pregnant women. The aims of this study were to assess the safety and the efficacy of tinzaparin sodium (Innohep) administered only once daily during pregnancy. A systematic retrospective review identified a cohort of 37 high-risk pregnancies which had been managed using tinzaparin 175 IU\\/kg once daily. In 26 cases, the index pregnancy had been complicated by development of an acute venous thromboembolism (17 deep vein thrombosis and nine pulmonary embolism). For each individual, case notes were examined and data extracted using a predetermined questionnaire. No episodes of recurrent venous thromboembolism were identified amongst this cohort of pregnancies managed using once daily LMWH administration. However, two unusual thrombotic complications were observed, including a parietal infarct in one patient, and a postpartum cerebral venous thrombosis in another. Once daily tinzaparin was well tolerated, with no cases of heparin-induced thrombocytopaenia, symptomatic osteoporosis, or foetal malformations. Tinzaparin dose modification based upon peak anti-Xa levels occurred in 45% of the cases examined. The present study is the largest study to have examined the clinical efficacy of once daily LMWH for use in pregnant women at high risk of venous thromboembolism. Our data support the safety and efficacy of antenatal tinzaparin at a dose of 175 IU\\/kg. In order to determine whether this once daily regimen provides equivalent (or indeed greater) thromboprophylaxis to twice daily LMWH regimens during pregnancy will require highly powered

  9. Highly Resistant Salmonella enterica Serovar Typhi with a Novel gyrA Mutation Raises Questions about the Long-Term Efficacy of Older Fluoroquinolones for Treating Typhoid Fever

    Science.gov (United States)

    Koirala, Kanika Deshpande; Thanh, Duy Pham; Thapa, Sudeep Dhoj; Arjyal, Amit; Karkey, Abhilasha; Dongol, Sabina; Shrestha, Upendra Man; Farrar, Jeremy J.; Baker, Stephen

    2012-01-01

    As a consequence of multidrug resistance, clinicians are highly dependent on fluoroquinolones for treating the serious systemic infection typhoid fever. While reduced susceptibility to fluoroquinolones, which lessens clinical efficacy, is becoming ubiquitous, comprehensive resistance is exceptional. Here we report ofloxacin treatment failure in typhoidal patient infected with a novel, highly fluoroquinolone-resistant isolate of Salmonella enterica serovar Typhi. The isolation of this organism has serious implications for the long-term efficacy of ciprofloxacin and ofloxacin for typhoid treatment. PMID:22371897

  10. Clinical efficacy of perampanel for partial-onset and primary generalized tonic-clonic seizures

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    Besag FM

    2016-05-01

    Full Text Available Frank MC Besag,1–3 Philip N Patsalos4,51East London Foundation NHS Trust, 2Institute of Psychiatry, Psychology and Neuroscience, 3UCL School of Pharmacy, 4Department of Clinical and Experimental Epilepsy, UCL Institute of Neurology, NIHR University College London Hospitals Biomedical Research Centre, London, 5Epilepsy Society, Chalfont Centre for Epilepsy, Chalfont St Peter, UKBackground and purpose: Perampanel, a selective noncompetitive antagonist at the α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA receptor, is highly effective in a wide range of experimental models. Although initially licensed as adjunctive therapy for partial seizures with or without secondary generalization in patients aged 12 years or older, the US Food and Drug Administration has recently approved its use in the treatment of primary generalized tonic–clonic seizures (PGTCS. This paper reviews the pharmacokinetics, efficacy, and tolerability of perampanel as an antiepileptic drug.Results: After oral ingestion, perampanel is rapidly absorbed (Tmax, 0.5–2.5 hours, has a bioavailability of ~100%, and is highly protein bound (~95% in plasma. It undergoes extensive (>90% hepatic metabolism, primarily via cytochrome P450 3A4 (CYP3A4, with a half-life of 48 hours. Carbamazepine and other antiepileptic drugs can enhance its metabolism via induction of CYP3A4. Efficacy of perampanel in focal seizures has been extensively evaluated in Phase II and randomized, placebo-controlled Phase III trials. The efficacy in PGTCS has been reported in one class I study. In the treatment of focal seizures, perampanel showed significant dose-dependent median seizure reductions: 4 mg/d, 23%; 8 mg/d, 26%–31%; 12 mg/d, 18%–35%; and placebo, 10%–21%. The 50% responder rates were 15%–26%, 29%, 33%–38%, and 34%–36% for placebo, 4 mg/d, 8 mg/d, and 12 mg/d perampanel, respectively. Freedom from seizures was recorded in 0%–1.7% of the placebo group, 1.9% of the 2

  11. [Clinical efficacy and safety of mifepristone in the treatment of abortive remnants of induced abortion].

    Science.gov (United States)

    Zhuge, Ting; Li, Bin; Huang, Zi-rong

    2012-01-03

    To evaluate the efficacy and safety of treating abortive remnants of induced abortion with different doses of mifepristone. A total of 101 women undergoing post-abortion treatment at our family planning clinic from October 2009 to February 2011 were recruited and divided randomly into 4 groups. They were diagnosed as abortive remnants by ultrasound and blood level of β-HCG (human chorionic gonadotrophin). Three test groups received different doses of mifepristone and one group as control. The efficacy and safety of four groups were evaluated by clinical observations, ultrasonic examinations and blood level of β-HCG. The effective rates of mifepristone test and control groups were 61.60% and 21.40% respectively. And there were statistical significances between two groups (P ultrasound were better than those of the control group. And there were significant statistical differences (P 0.05). There was statistical significance in pairwise comparison on reduction of residual size tested by ultrasound among test groups (P 0.05). Mifepristone is effective in the treatment of induced incomplete abortion. And a short-term large dose offers a better efficacy.

  12. Computer Self-Efficacy among Senior High School Teachers in Ghana and the Functionality of Demographic Variables on Their Computer Self-Efficacy

    Science.gov (United States)

    Sarfo, Frederick Kwaku; Amankwah, Francis; Konin, Daniel

    2017-01-01

    The study is aimed at investigating 1) the level of computer self-efficacy among public senior high school (SHS) teachers in Ghana and 2) the functionality of teachers' age, gender, and computer experiences on their computer self-efficacy. Four hundred and Seven (407) SHS teachers were used for the study. The "Computer Self-Efficacy"…

  13. Randomised Clinical Efficacy Trial of Topiramate and Nitrazepam in Treatment of Infantile Spasms

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    Razieh FALLAH

    2013-12-01

    Full Text Available Abstract How to Cite This Article: Fallah R, Salor F, Akhavan Karbasi S, Motaghipisheh H. Randomised Clinical Efficacy Trial of Topiramate and Nitrazepam in Treatment of Infantile Spasms. Iran J Child Neurol. 2014 Winter; 8(1:12-19. Objective Infantile spasms (IS are among the most catastrophic epileptic syndromes of infancy. The purpose of this study was to compare efficacy and safety of topiramate (TPM and nitrazepam (NZP as first-line drugs in the treatment of IS. Materials & Methods In a parallel single-blinded randomized clinical trial, 50 patients with IS referred to Pediatric Neurology Clinic of Shahid Sadoughi University of Medical Sciences, Yazd, Iran, were evaluated from September 2008 to March 2010. Patients were randomly assigned to two groups to be treated with TPM or with NZP for 6 months. The primary endpoint was efficacy in cessation of all spasms or reduction of more than 50% in weekly seizure frequency, which was evaluated before and 6 months after the drug use. Secondary outcome was clinical sideeffects of the drugs. Results Twenty boys (40% and 30 girls (60% with the mean age of 9.4±3.8 months were evaluated. Cessation of all spasms occurred in 12 (48% infants in TPM group and 4(16% in NZP group. Eight (32% children in TPM group and 7 (28% in NZP group had more than 50% reduction in spasms frequency. So, TPM was more effective. Side effects were seen in 32% of TPM and in 36% of NZP groups. Conclusion Topiramate is an effective and safe drug, which might be considered as the firstline drug for the treatment of ISs.

  14. Clinical efficacy of a new ciclopiroxolamine/zinc pyrithione shampoo in scalp seborrheic dermatitis treatment.

    Science.gov (United States)

    Lorette, Gérard; Ermosilla, Valérie

    2006-01-01

    Ciclopiroxolamine (CPO) and Zinc Pirythione (ZP) antifungals are efficient at treating scalp seborrheic dermatitis. This multicentre, single-blind, clinical study was conducted to evaluate the efficacy of a shampoo containing the 1.5% CPO/1% ZP association compared to the vehicle shampoo and to 2% ketoconazole foaming gel in the treatment of seborrheic dermatitis. In 189 patients randomised to apply 1 of the 3 products twice a week for 28 days, the global lesional score, erythema, pruritus, global efficacy, quality of life (SF12 and DLQI questionnaires) and tolerance were measured at 0, 7, 14 and 28 days. The 3 products reduced lesional score, erythema and pruritus from day 7 (p shampoo was more efficient in reducing pruritus than ketoconazole gel and vehicle (p = 0.032 and p shampoo improved all DLQI questionnaire dimensions. The CPO/ZP shampoo was as rapid and efficient as ketoconazole gel in SD treatment.

  15. A comparison of five approaches to decision-making for a first clinical trial of efficacy.

    Science.gov (United States)

    Kirby, Simon; Chuang-Stein, Christy

    2017-01-01

    The first trial of clinical efficacy is an important step in the development of a compound. Such a trial gives the first indication of whether a compound is likely to have the efficacy needed to be successful. Good decisions dictate that good compounds have a large probability of being progressed and poor compounds have a large probability of being stopped. In this paper, we consider and contrast five approaches to decision-making that have been used. To illustrate the use of the five approaches, we conduct a comparison for two plausible scenarios with associated assumptions for sample sizing. The comparison shows some large differences in performance characteristics of the different procedures. Which decision-making procedures and associated performance characteristics are preferred will depend on the focus of interest and the decision maker's attitude to risk. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

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

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    Adalatkhah H

    2015-08-01

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

  17. Efficacy and acceptability of early mifepristone-misoprostol medical abortion in Ukraine: results of two clinical trials.

    Science.gov (United States)

    Raghavan, Sheila; Maistruk, Galina; Shochet, Tara; Bannikov, Vladimir; Posohova, Svetlana; Zhuk, Svetlana; Lishchuk, Vladimir; Winikoff, Beverly

    2013-04-01

    Abortion services are legally available in Ukraine although there are issues in quality and access. Two studies were conducted in Ukraine to expand options for women, and to determine the efficacy and acceptability of medical abortion. Two open-label clinical trials were conducted at six clinics in Ukraine. Women were given 200 mg mifepristone followed after 48 hours by 400 μg oral misoprostol (Study One) and mifepristone followed after 24 hours by 400 μg sublingual misoprostol (Study Two). Follow-up visits were scheduled for two weeks after mifepristone administration to assess whether complete uterine evacuation had occurred. Success rates were 97% in the first study and 98% in the second one. The vast majority of participants were satisfied or very satisfied with their abortion method (Study One: 94%; Study Two: 98%). The two studies demonstrate high rates of success and acceptability of early medical abortion in Ukraine.

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

    LENUS (Irish Health Repository)

    Reyad, A

    2009-06-01

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

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

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    John F. Flynn

    2009-01-01

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

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

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    Yoshiki Matsuda

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

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

    Science.gov (United States)

    Matsuda, Yoshiki; Sugiura, Keita; Hashimoto, Takashi; Ueda, Akane; Konno, Yoshihiro; Tatsumi, Yoshiyuki

    2016-01-01

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

  2. Clinical efficacy of Amalaki Rasayana in the management of Pandu (Iron deficiency anemia)

    Science.gov (United States)

    Layeeq, Shaizi; Thakar, Anup B.

    2015-01-01

    Introduction: Iron deficiency anemia (IDA) is one of the most common nutritional deficiencies worldwide, which can be correlated to Pandu described in ayurvedic classics. Poor absorption of iron is one of the main reasons of IDA. Amalaki (Phyllanthus emblica L.) has Tridoshahara, especially Pittashamaka (pacifying Pitta) and Rasayana (rejuvenative) properties, thus nourishes the Dhatus and is also known to enhance the absorption of iron. Aims: To evaluate the efficacy of Amalaki Rasayana in the management of Pandu w.s.r. IDA. Materials and Methods: A randomized controlled open clinical trial was conducted at Institute for Post Graduate Teaching and Research in Ayurveda, Jamnagar. Iron deficient anemic patients (n = 25) having Hb <12g% in females and 13g% in males and S.Iron <50mg/dl were selected and divided into two groups. Group A was given 2 g of Amalaki Rasayana thrice a day with unequal quantity of honey and ghee for 45 days, while Group B was given 150 mg ferrous fumarate + 1500 mcg folic acid (standard control) once a day with water for 45 days. Assessment was done on the basis of relief in cardinal symptoms of Pandu and hematological parameters. Results and Conclusion: The formulation showed highly significant relief in Panduta (pallor), Daurbalya (weakness), Shirahshoola (headache), Shrama (fatigue), and Gaurava (heaviness) while statistically significant relief in Aruchi (anorexia) and Pindikodweshtan (leg cramps) was reported. On hematological parameters statistically significant increase was found in mean corpuscular volume and mean corpuscular hemoglobin while on biochemical markers statistically significant decrease was found in total iron binding capacity only. However the formulation was not found as effective as standard control. PMID:27313416

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

    Science.gov (United States)

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

    2015-09-01

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

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2013-02-15

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

  5. Extracorporeal shock wave therapy (ESWT) for wound healing: technology, mechanisms, and clinical efficacy.

    Science.gov (United States)

    Mittermayr, Rainer; Antonic, Vlado; Hartinger, Joachim; Kaufmann, Hanna; Redl, Heinz; Téot, Luc; Stojadinovic, Alexander; Schaden, Wolfgang

    2012-01-01

    For almost 30 years, extracorporeal shock wave therapy has been clinically implemented as an effective treatment to disintegrate urinary stones. This technology has also emerged as an effective noninvasive treatment modality for several orthopedic and traumatic indications including problematic soft tissue wounds. Delayed/nonhealing or chronic wounds constitute a burden for each patient affected, significantly impairing quality of life. Intensive wound care is required, and this places an enormous burden on society in terms of lost productivity and healthcare costs. Therefore, cost-effective, noninvasive, and efficacious treatments are imperative to achieve both (accelerated and complete) healing of problematic wounds and reduce treatment-related costs. Several experimental and clinical studies show efficacy for extracorporeal shock wave therapy as means to accelerate tissue repair and regeneration in various wounds. However, the biomolecular mechanism by which this treatment modality exerts its therapeutic effects remains unclear. Potential mechanisms, which are discussed herein, include initial neovascularization with ensuing durable and functional angiogenesis. Furthermore, recruitment of mesenchymal stem cells, stimulated cell proliferation and differentiation, and anti-inflammatory and antimicrobial effects as well as suppression of nociception are considered important facets of the biological responses to therapeutic shock waves. This review aims to provide an overview of shock wave therapy, its history and development as well as its current place in clinical practice. Recent research advances are discussed emphasizing the role of extracorporeal shock wave therapy in soft tissue wound healing.

  6. Clinical and in vitro efficacy of amoxicillin against bacteria associated with feline skin wounds and abscesses.

    Science.gov (United States)

    Roy, Josée; Messier, Serge; Labrecque, Olivia; Cox, William R

    2007-06-01

    A clinical trial involving 122 cats with infected skin wounds or abscesses presented to 10 veterinary clinics was conducted to evaluate the efficacy of 2 oral amoxicillin drug products (a paste and a suspension). A 2nd objective of the study was to identify bacteria involved in such infections and verify their in vitro sensitivity to amoxicillin. Samples of wound exudate were harvested at the time of presentation and submitted for aerobic and anaerobic culture. The sensitivity to amoxicillin of isolates thought to be infecting agents was tested, using a standard minimum inhibitory concentration method. Pasteuralla multocida and obligate anaerobes of the genera Prevotella, Fusobacterium, and Porphyromonas were the most frequently isolated pathogens. Overall, their in vitro susceptibility to amoxicillin was very good. Both drug products were clinically efficacious with a global success rate of 95.1% for cats administered oral amoxicillin at 11-22 mg/kg bodyweight (mean 13.8 mg/kg bodyweight) twice daily for 7 to 10 days.

  7. Efficacy Outcome Measures for Procedural Sedation Clinical Trials in Adults: An ACTTION Systematic Review.

    Science.gov (United States)

    Williams, Mark R; McKeown, Andrew; Dexter, Franklin; Miner, James R; Sessler, Daniel I; Vargo, John; Turk, Dennis C; Dworkin, Robert H

    2016-01-01

    Successful procedural sedation represents a spectrum of patient- and clinician-related goals. The absence of a gold-standard measure of the efficacy of procedural sedation has led to a variety of outcomes being used in clinical trials, with the consequent lack of consistency among measures, making comparisons among trials and meta-analyses challenging. We evaluated which existing measures have undergone psychometric analysis in a procedural sedation setting and whether the validity of any of these measures support their use across the range of procedures for which sedation is indicated. Numerous measures were found to have been used in clinical research on procedural sedation across a wide range of procedures. However, reliability and validity have been evaluated for only a limited number of sedation scales, observer-rated pain/discomfort scales, and satisfaction measures in only a few categories of procedures. Typically, studies only examined 1 or 2 aspects of scale validity. The results are likely unique to the specific clinical settings they were tested in. Certain scales, for example, those requiring motor stimulation, are unsuitable to evaluate sedation for procedures where movement is prohibited (e.g., magnetic resonance imaging scans). Further work is required to evaluate existing measures for procedures for which they were not developed. Depending on the outcomes of these efforts, it might ultimately be necessary to consider measures of sedation efficacy to be procedure specific.

  8. Impact of critical thinking disposition, general self-efficacy, and leadership on clinical competence in nursing students.

    Science.gov (United States)

    Park, Jee Won; Kim, Chun Ja; Kim, Yong Soon; Yoo, Moon Sook; Yoo, Hyera; Chae, Sun Mi; Ahn, Jeong Ah

    2012-09-01

    The purpose of this study was to evaluate the relationships among critical thinking disposition, general self-efficacy, leadership and clinical competence, and identify the factors influencing clinical competence in nursing students. In this descriptive study, 153 nursing students (from 2nd to 4th school year) of a university in South Korea were enrolled in December 2010. The instruments for this study were the Korean versions of the Critical Thinking Disposition Scale, General Self-Efficacy Scale, Leadership Inventory, and Clinical Competence Scale. Data were analyzed by descriptive statistics, t-test, MANOVA, Pearson correlation, and multiple linear regression with PASW 18.0 software. The mean scores (ranging from 1 to 5) in nursing students for critical thinking disposition, general self-efficacy, leadership, and clinical competence were 3.44, 3.51, 3.55, and 3.42, respectively. Positive correlations were found for clinical competence with critical thinking disposition, general self-efficacy, and leadership. The strongest predictor of clinical competence was leadership. In addition, leadership, nursing school year, and subjective academic achievement accounted for 34.5% of variance in clinical competence. This study revealed that developing leadership, critical thinking disposition, and self-efficacy in undergraduate nursing education is important to improve clinical competence of nursing students.

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

    Institute of Scientific and Technical Information of China (English)

    Ya-Ting Shao; Xin-Liang Huang; Tiao Bai

    2016-01-01

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

  10. The impact of collective teacher efficacy on student achievement in high school science

    Science.gov (United States)

    Burcham, Mark W.

    This dissertation was designed to examine the impact of collective teacher efficacy on high school science achievement by looking at relationships among collective teacher efficacy, its two constructs, group competence and group task analysis, and high school science achievement scores at four rural high schools in Northwestern North Carolina. The researcher gathered historical test data from the testing coordinator from the school system and then administered the Collective Teacher Efficacy Instrument, developed by Goddard, Hoy, and Woolfolk Hoy (2000), to 24 science teachers from the four high schools. Using this information, the researcher conducted statistical analyses to determine the relationships among collective teacher efficacy, group competence, and group task analysis as compared with the tested science curriculum (physical science, biology, chemistry, and physics). The researcher also examined which construct was the most contributing factor and examined differences in efficacy levels and student achievement levels at each high school. Analysis of the data from this study indicated collective teacher efficacy, as well as its two constructs, group competence and group task analysis, does have a positive impact on student achievement in high school science. Analysis of the data revealed group competence is the major contributing factor for student achievement in biology and group task analysis is the major contributing factor for student achievement in physical science, chemistry, and physics. Further analysis of the data in this study, also revealed that the two high schools with the highest levels of collective teacher efficacy had the highest levels of student achievement.

  11. Evaluating High School Students' Anxiety and Self-Efficacy towards Biology

    Science.gov (United States)

    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…

  12. Achievement, School Integration, and Self-Efficacy in Single-Sex and Coeducational Parochial High Schools

    Science.gov (United States)

    Micucci, Kara Hanson

    2014-01-01

    A structural model for prior achievement, school integration, and self-efficacy was developed using Tinto's theory of student attrition and Bandura's self-efficacy theory. The model was tested and revised using a sample of 1,452 males and females from single-sex and coeducational parochial high schools. Results indicated that the theoretically…

  13. Rural High School Teachers' Self-Efficacy in Student Engagement, Instructional Strategies, and Classroom Management

    Science.gov (United States)

    Shoulders, Tori L.; Krei, Melinda Scott

    2015-01-01

    The purpose of this study was to compare the differences in rural high school teachers' (n = 256) self-efficacy in student engagement, instructional practices, and classroom management using selected teacher characteristics. Analysis of variance showed significant mean differences between different levels of education in self-efficacy for…

  14. Evaluating High School Students' Anxiety and Self-Efficacy towards Biology

    Science.gov (United States)

    Çimen, Osman; Yilmaz, Mehmet

    2015-01-01

    Anxiety and self-efficacy are among the factors that impact students' performance in biology. The current study aims to investigate high school students' perception of biology anxiety and self-efficacy, in relation to gender, grade level, interest in biology, negative experience associated with biology classes, and teachers' approaches in the…

  15. Measuring University Students' Perceived Self-Efficacy in Science Communication in Middle and High Schools

    Science.gov (United States)

    Chi, Shaohui; Liu, Xiufeng; Gardella, Joseph A.

    2016-01-01

    Service learning typically involves university students in teaching and learning activities for middle and high school students, however, measurement of university students' self-efficacy in science communication is still lacking. In this study, an instrument to measure university students' perceived self-efficacy in communicating science to…

  16. Special Education Teachers' Self-Efficacy Beliefs in a Large Urban High School

    Science.gov (United States)

    Seebeck, Kelly A.

    2016-01-01

    The purpose of this study was to identify if special education teachers' self-efficacy beliefs are impacted by student engagement, instructional strategies, and classroom management. Specifically, this study focused on the self-efficacy of high school special education teachers in an urban setting. This was a correlational quantitative design…

  17. Rural High School Teachers' Self-Efficacy in Student Engagement, Instructional Strategies, and Classroom Management

    Science.gov (United States)

    Shoulders, Tori L.; Krei, Melinda Scott

    2015-01-01

    The purpose of this study was to compare the differences in rural high school teachers' (n = 256) self-efficacy in student engagement, instructional practices, and classroom management using selected teacher characteristics. Analysis of variance showed significant mean differences between different levels of education in self-efficacy for…

  18. Randomized Clinical Trial: Efficacy of a New Synbiotic in Adults with Metabolic Syndrome

    Directory of Open Access Journals (Sweden)

    Almagul Kushugulova

    2014-01-01

    Full Text Available Introduction: Metabolic syndrome is a lifestyle disease and is a frequent problem among the adult population. Human gut microbiota plays a key role in the development of metabolic syndrome. Recently, the gut microbiota has emerged as an important contributor to the development of obesity and metabolic disorders through its interactions with environmental (e.g. diet and genetic factors. The aim of this study was to research the effects of synbiotic on the gut microbiota and host metabolism. Methods: We conducted a double-blind, randomized, placebo-controlled trial. Our sample included 180 adults (ages 30-89 with symptoms of metabolic syndrome, who were allocated to either placebo or synbiotic group. The main inclusion criteria were: blood pressure of around 130/90 mmHg; raised fasting plasma glucose (FPG >100 mg/dL (5.6 mmol/L, previous diagnosis of type 2 diabetes, dyslipidemia triglycerides (TG of 1.70 mmol/L, a high-density lipoprotein cholesterol (HDL-C of 0.90 mmol/L in males and 1.0 mmol/L in females, and central obesity with a waist/hip ratio > 0.90 in males or > 0.85 in females or a body mass index > 30 kg/m2. Results: We enrolled 90 adults in the placebo group and 90 in the synbiotic group. The two groups had similar demographic and clinical characteristics. Consent was signed by all patients. All patients underwent clinical and laboratory evaluation, including complete blood tests, glucose test, glycosylated  hemoglobin, total cholesterol and triglycerides, cholesterol, LDL, HDL plasma, immunogram, and coprogram. All patients were interviewed with a questionnaire that included 200 questions related to diet, lifestyle, and health. Synbiotic were used by patients in a dose of 200 grams twice a day. The duration of applying of the synbiotic was 90 days. To study the composition of the intestinal microbiota, stool samples were collected before and after applying the synbiotic. The microbial composition will be determined by analyzing the

  19. The Effects of Triggers’ Modifying on Adolescent Self-Efficacy with Asthma: A Randomized Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    Leila Valizadeh

    2014-06-01

    Full Text Available Introduction: The management of asthma during adolescence has specific challenges and is likely influenced, to some extent, by the patient's belief in their ability to affect change, their self-efficacy. Bolstering self-efficacy could potentially improve an adolescent’s ability to self-manage their asthma. The aim of this study was to examine the effects of a triggers’ educational-modifying intervention on self-efficacy among adolescents diagnosed with asthma living in Iran. Methods: Sixty adolescents, aged 12 to 18 years, diagnosed with asthma participated in this randomized clinical trial. Participants randomly assigned to the control group received standard care while those assigned to the experimental group participated in a 5 week, nurse led, triggers modifying educational intervention in specialized clinics of lung in Tabriz, Iran. The self-efficacy scale developed by Bursh et al., was used for data collection. Results: The level of self- efficacy in two groups before intervention was not statistically significant, while the post intervention measures were statistically significant. Intervention was effective in improving adolescents’ self-efficacy. Conclusion: Since this type of intervention has the potential to improve Self- efficacy in adolescents with asthma, it is suggested that adolescence directly education about asthma triggers along with modulating triggers will be of value and parent‐centered could be diminished. The need for such interventions emphasizes in clinic and outpatient clinics.

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

    Directory of Open Access Journals (Sweden)

    Ismail Simsek

    2010-09-01

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

  1. Comparative antiplaque and antigingivitis efficacy of three antiseptic mouthrinses: a two week randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Pejmon Amini

    2009-09-01

    Full Text Available The objective of this randomized, examiner blind, parallel group, controlled clinical trial was to compare the antiplaque and antigingivitis efficacy of an essential oil-containing mouthrinse (EO to two mouthrinses containing 0.05% Cetylpyridinium Chloride (CPC, one with alcohol and one alcohol-free, using a two-week experimental gingivitis validated-model with a 5% hydroalcohol rinse serving as the negative control. One hundred and fifty-nine subjects, 56 males and 103 females; ranging in age from 18 to 58 years in good general health were assigned to one of the four treatment groups: EO (n = 40, 0.05% CPC with alcohol (CPCa, n = 39, 0.05% CPC alcohol-free (CPCna, n = 40, and 5% hydroalcohol negative control (n = 40. The Mean Turesky Modification of the Quigley-Hein Plaque Index (PI and the Mean Modified Gingival Index (MGI were the primary efficacy endpoints and were evaluated at baseline and at two weeks. Following baseline examinations, subjects received a complete dental prophylaxis and began supervised rinsing with their assigned mouthrinse twice daily for two weeks, as their sole oral hygiene measure; 151 subjects completed the trial. Two weeks after baseline the EO adjusted mean PI and MGI scores were significantly lower than those of both CPC rinses and negative control (p < 0.001. In conclusion, the EO mouthrinse demonstrated significantly greater antiplaque and antigingivitis efficacy than both CPC-containing mouthrinses and the negative control.

  2. Clinical efficacy of intravenous administration of marbofloxacin in a Staphylococcus aureus infection in tissue cages in ponies.

    Science.gov (United States)

    Voermans, M; van Soest, J M; van Duijkeren, E; Ensink, J M

    2006-12-01

    Tissue cages (TC), implanted subcutaneously in the neck in eight ponies, were inoculated with Staphylococcus aureus (S. aureus) to determine the clinical efficacy of marbofloxacin in the treatment of this infection. From 21 h after inoculation, marbofloxacin (6 mg/kg) was administered intravenously (i.v.) once daily for 7 days. Samples of the tissue cage fluid (TCF) were taken to determine marbofloxacin concentrations (days 1, 3 and 7), using high-pressure liquid chromatography, and numbers of viable bacteria [colony forming units (CFU)] (days 1, 3, 7, 14 and 21). Statistical analysis was used to compare CFU before and after treatment. Clinical signs and CFU were used to evaluate the efficacy of treatment. Although, there was a slight decrease in CFU in all TC initially, the infection was not eliminated by marbofloxacin treatment in any of the ponies and abscesses formed. As the MIC (0.25 microg/mL) did not change during treatment and the concentration of marbofloxacin during treatment (mean concentration in TCF was 0.89 microg/mL on day 1, 0.80 microg/mL on day 3 and 2.77 microg/mL on day 7) was above MIC, we consider that the treatment failure might be attributable to the formation of a biofilm by S. aureus. Based on the present results, i.v. administration of marbofloxacin alone is not suitable for the elimination of S. aureus infections from secluded sites.

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

    Directory of Open Access Journals (Sweden)

    Jaung-Geng Lin

    2013-01-01

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

  4. A clinical study to assess the anticalculus efficacy of a new dentifrice containing a special grade of silica (Colgate Total Plus Whitening Toothpaste): a clinical trial on adults.

    Science.gov (United States)

    Sowinski, Joseph A; Battista, Guido W; Petrone, Dolores M; Petrone, Margaret E; DeVizio, William; Volpe, Anthony R

    2002-01-01

    The objective of this double-blind clinical study, conducted using the Volpe-Manhold design for studies of dental calculus, was to confirm the supragingival anticalculus efficacy of a formulation variant of a commercially available anticalculus dentifrice. The commercially available dentifrice (Colgate Total Toothpaste) contains 0.3% triclosan and 2.0% PVM/MA copolymer in a 0.243% sodium fluoride/silica base. The new formulation variant contains those same ingredients, of which 10% of the silica is a high cleaning grade (Colgate Total Plus Whitening Toothpaste). In this study, the dentifrice formulation variant was tested for anticalculus efficacy against a negative control dentifrice containing 0.243% sodium fluoride/silica. Adult male and female subjects from the northern New Jersey area were entered into the study based on a pre-test (baseline) Volpe-Manhold Calculus Index score of 7.0 or greater, provided a full oral prophylaxis, and stratified into two treatment groups which were balanced for age, sex, and baseline calculus scores. Subjects were instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned dentifrice, using a soft-bristled toothbrush. Examinations for dental calculus were again performed after eight weeks' use of the study dentifrices. Sixty-three (63) subjects complied with the protocol and completed the entire study. At the eight-week examination, subjects in the Colgate Total Plus Whitening Toothpaste group exhibited a statistically significant 34.13% reduction in mean Volpe-Manhold Calculus Index score as compared to the negative control dentifrice group. Thus, the results of this clinical study support the conclusion that a new dentifrice formulation variant containing a special grade of silica (Colgate Total Plus Whitening Toothpaste) is efficacious for the control of the formation of supragingival calculus.

  5. [Clinical efficacy of mecobalamin in the treatment of oligozoospermia--results of double-blind comparative clinical study].

    Science.gov (United States)

    Kumamoto, Y; Maruta, H; Ishigami, J; Kamidono, S; Orikasa, S; Kimura, M; Yamanaka, H; Kurihara, H; Koiso, K; Okada, K

    1988-06-01

    The clinical efficacy of mecobalamin in the treatment of male infertility was investigated by means of a multicenter collaborative study with 25 participating institutions. The study was carried out as a double-blind, comparative trial using three administration groups: 6,000 micrograms of mecobalamin per day, 1,500 micrograms of mecobalamin per day and a placebo group for 12 wk. The following results were obtained. 1. The total number of evaluated subjects was 375, consisting of 125 in the 6,000 micrograms/day mecobalamin group, 124 in the 1,500 micrograms/day mecobalamin group and 126 in the placebo group. There were no significant differences among the three administration groups in terms of the patient's background factors. 2. When all of the patients were analyzed, there were no statistically significant differences among the three administration groups in terms of the efficacy in relation to the sperm count or the motility rate. 3. However, it was decided to perform a more detailed analysis of the therapeutic efficacy in patients whose pretreatment sperm counts were 20 x 10(6)/ml or less. The reasons for this decision were two-fold: 1) There was a large degree of fluctuation in patients whose pretreatment sperm counts showed a mean value of more than 20 x 10(6)/ml for two or more determinations, and it was surmised that this fluctuation might have masked any therapeutic effect in those cases. 2) The WHO definition of oligozoospermia was recently decided as a sperm count of 20 x 10(6)/ml or less.(ABSTRACT TRUNCATED AT 250 WORDS)

  6. Suprofen: the pharmacology and clinical efficacy of a new non-narcotic peripheral analgesic.

    Science.gov (United States)

    Tolman, E L; Rosenthale, M E; Capetola, R J; McGuire, J L

    1984-08-01

    Suprofen is a potent, peripherally-acting, non-narcotic analgesic agent. The mechanism of action of the compound involves inhibition of prostaglandin biosynthesis and, perhaps, direct antagonism of the peripheral, pain inducing actions of prostaglandins, bradykinin and other pain mediators. Suprofen at a dose of 200 mg appears to be equal or greater in efficacy as an analgesic modality than those of ibuprofen, propoxyphene, naproxen and diflunisal or a combination of 650 mg aspirin plus 60 mg codeine. Its clinical utility has been amply demonstrated in the treatment of a number of types of pain including general and orthopedic surgery, episiotomy, post-partum pain, dysmenorrhea, dental pain and musculoskeletal disorders. Suprofen represents a new class of orally effective nonnarcotic analgesics with potential for effective clinical use in the treatment of pain.

  7. [Analyses of clinical features and efficacy of sudden deafness with vertigo and dizziness].

    Science.gov (United States)

    Liu, Bo; Han, Demin; Zhang, Yi; Li, Yongxin; Gong, Shusheng; Chen, Xiuwu; Meng, Xixi; Tang, Junxiang; Xiang, Jie; Jiang, Xuejun; Yang, Ning; Tian, Ying; Hui, Lian; Feng, Shuai

    2015-06-01

    To investigate the clinical characteristics and the effect of drug treatment for sudden hearing loss with vertigo or dizziness. In a prospective, randomized, single blinded randomized multicenter clinical study, patients with sudden deafness, ranging in age from 18 to 65 years old, with a duration less than 2 weeks, and with no any medical treatments were collected. In accordance with the hearing curve, those patients were divided into four types, i.e., low and intermediate frequency descent type; high frequency descent type; fall flat type; and total deafness type. Each type was treated by four different treatment options, according to the unified design of the random table, and randomly selected one of the options for treatment. The efficacy of the patients with sudden deafness with vertigo and dizziness was analyzed statistically after the follow-up for 4 weeks. SPSS 13.0 software was used to analyze the data. In August 2007 to October 2011, 33 hospitals in the country included 1 024 patients with sudden deafness in line with the inclusion criteria, of whom 296 (28.91%) were accompanied by vertigo/dizziness symptoms, 126 were males and 170 were females, with an average age of (41.2 ± 13.5) years old. types of the different audiometric curves of sudden deafness, the occurrence of complete deafness with vertigo/dizziness was the highest (44.93%), followed by flat down type (25.87%), high frequency descent type (21.28%) and low intermediate frequency descent type (18.54%). After the standard treatment, the vertigo and dizziness symptoms of the sudden deafness patients could disappear, and the hearing in each group was obviously improved. The hearing curative effect on patients accompanied by vertigo/dizziness of low frequency and intermediate frequency descent type was the best, and the total efficiency can reach up to 94.74%, with the cure rate of 68.42%; followed by flat type, in which the total effective rate was 80.76%, with the recovery rate of 22.12%; and

  8. Role expansion on interprofessional primary care teams: Barriers of role self-efficacy among clinical associates.

    Science.gov (United States)

    Giannitrapani, Karleen F; Soban, Lynn; Hamilton, Alison B; Rodriguez, Hector; Huynh, Alexis; Stockdale, Susan; Yano, Elizabeth M; Rubenstein, Lisa V

    2016-12-01

    Interprofessional team-based models of primary care that expand the role of clinical associates (CAs) are increasingly adopted in primary care practices. In this study we query team members of a newly implemented patient centered medical home (PCMH) to identify facilitators and barriers of occupational role self-efficacy, a belief of possessing the capacity to execute their new team based role effectively. 79 key informants, members of primary care teams at six Veterans Health Administration (VA) clinics, were interviewed to assess their experiences with implementing expanded roles for CAs. All sites had implemented Patient Aligned Care Teams, the VA's version of PCMH. Three themes that produced the self-efficacy necessary for successful role expansion of CAs were identified: (1) role training (2) time and resources for roles and (3) cross-disciplinary role agreement. Sub-themes emerged around role challenges. Training sub themes included incomplete or limited training, inconsistencies in trainings within a site, and not receiving training with team members. Insufficient resources sub-themes included limited time for expanded tasks, inadequate space, low staffing, and poor task mix. Cross-disciplinary agreement failed to occur specifically when there was insufficient coordination between medicine and nursing leadership about staff roles, poor primary care provider (PCPs) knowledge of the boundaries of staff roles, and lack of synchronicity between staff roles and what PCPs would like staff roles to include. These identified themes have implications for healthcare professionals working in interprofessional teams in a variety of settings and indicate the need for interdisciplinary leadership based solutions. Clarifying the factors that impact self-efficacy for the role expansion of PACT staff can inform strategies for role transformation for enhanced primary care delivery. Published by Elsevier Inc.

  9. Randomized clinical efficacy of superficial peeling with 85% lactic acid versus 70% glycolic acid*

    Science.gov (United States)

    Prestes, Paula Souza; de Oliveira, Márcia Motta Maia; Leonardi, Gislaine Ricci

    2013-01-01

    BACKGROUND: Peeling is a procedure which aims to accelerate the process of skin exfoliation. OBJECTIVES Development of formulations containing lactic acid at 85% or glycolic acid at 70% and the evaluation of these formulations on clinical efficacy in reduction of fine wrinkles. METHODS Preliminary stability tests were carried out and an in vivo study was performed with three groups with 9 representatives each. One was the control group, which used only sunscreen; another one used lactic acid+sunscreen, and the last group used acid glycolic+sunscreen. Clinical efficacy was assessed with a CCD color microscope, through the digitization of images before and after treatment. The applications were carried out by a dermatologist, once a mont h every 30 days, during 3 months. The area with wrinkles was calculated by planimetry point counting, in accordance with Mandarin-de-Lacerda. RESULTS The formulations were stable in the visual and Ph evaluation. There was no improvement in the control group; for lactic acid, there was significant improvement after the second peeling application on the outer lateral area of the right eye and after the third application on the outer lateral area of the left eye. For the glycolic acid group, there was significant improvement in the outer lateral area of the left eye after the first application, and of the right eye region, after three applications. The formulations used must be kept under refrigeration and should be manipulated every 30 days. CONCLUSIONS Both peelings were effective in reducing fine wrinkles of the outer lateral eye area after three applications (p≤0.05%). It was observed that peeling efficacy in the external-lateral region of one eye might be different compared with that in skin of the external-lateral region of the other eye, relative to the speed of skin improvement. PMID:24474097

  10. Randomized clinical efficacy of superficial peeling with 85% lactic acid versus 70% glycolic acid.

    Science.gov (United States)

    Prestes, Paula Souza; Oliveira, Márcia Motta Maia de; Leonardi, Gislaine Ricci

    2013-01-01

    Peeling is a procedure which aims to accelerate the process of skin exfoliation. Development of formulations containing lactic acid at 85% or glycolic acid at 70% and the evaluation of these formulations on clinical efficacy in reduction of fine wrinkles. Preliminary stability tests were carried out and an in vivo study was performed with three groups with 9 representatives each. One was the control group, which used only sunscreen; another one used lactic acid+sunscreen, and the last group used acid glycolic+sunscreen. Clinical efficacy was assessed with a CCD color microscope, through the digitization of images before and after treatment. The applications were carried out by a dermatologist, once a mont h every 30 days, during 3 months. The area with wrinkles was calculated by planimetry point counting, in accordance with Mandarin-de-Lacerda. The formulations were stable in the visual and Ph evaluation. There was no improvement in the control group; for lactic acid, there was significant improvement after the second peeling application on the outer lateral area of the right eye and after the third application on the outer lateral area of the left eye. For the glycolic acid group, there was significant improvement in the outer lateral area of the left eye after the first application, and of the right eye region, after three applications. The formulations used must be kept under refrigeration and should be manipulated every 30 days. Both peelings were effective in reducing fine wrinkles of the outer lateral eye area after three applications (p ≤ 0.05%). It was observed that peeling efficacy in the external-lateral region of one eye might be different compared with that in skin of the external-lateral region of the other eye, relative to the speed of skin improvement.

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

    Science.gov (United States)

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

    2017-01-01

    The comparative efficacy and safety profiles of selected daily 1000 IU, weekly 7000 IU and monthly 30,000 IU vitamin D 3-not previously investigated-will be evaluated. Here, a prospective, randomized clinical trial, comparing efficacy and safety of a daily single dose of 1000 IU (group A) to a once-weekly 7000 IU dose (group B), or monthly 30,000 IU dose (group C) of vitamin D3. The present study is a controlled, randomized, open-label, multicenter clinical trial, 3  months in duration. Sixty-four adult subjects with vitamin D deficiency (25OHD<20 ng/ml), were included according to the inclusion and exclusion criteria. Dose-responses for increases in serum vitamin 25OHD were statistically equivalent for each of the three groups: A, B and C. Outcomes were 13.0 ± 1.5; 12.6 ± 1.1 and 12.9 ± 0.9 ng/ml increases in serum 25OHD per 1000 IU, daily, weekly and monthly, respectively. The treatment of subjects with selected doses restored 25OHD values to levels above 20 ng/ml in all groups. Treatment with distinct administration frequency of vitamin D3 did not exhibit any differences in safety parameters. The daily, weekly and monthly administrations of daily equivalent of 1000 IU of vitamin D3 provide equal efficacy and safety profiles.

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

    Directory of Open Access Journals (Sweden)

    Natalie E. Nieuwenhuizen

    2017-09-01

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

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

    Science.gov (United States)

    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.

  14. Randomised clinical efficacy trial of potassium oxalate mouthrinse in relieving dentinal sensitivity.

    Science.gov (United States)

    Sharma, Deepak; McGuire, James A; Gallob, John T; Amini, Pejmon

    2013-07-01

    The study aimed to determine the efficacy in relieving dentinal sensitivity of 4 weeks' treatment with an alcohol-free mouthrinse comprising 1.4% potassium oxalate (KO) (Listerine® Advanced Defence Sensitive; LADS), compared with negative and positive controls. Subjects were randomised to one of three treatments: LADS mouthrinse - twice-daily toothbrushing with Crest® Cavity Protection Regular toothpaste, rinsing with water and then 10 mL LADS mouthrinse, followed by expectoration; negative control (twice-daily brushing with Crest Cavity Protection Regular toothpaste); or positive control (twice-daily brushing with Sensodyne® Original desensitising toothpaste). Dentine sensitivity was assessed at baseline and after 2 and 4 weeks by Yeaple probe (tactile pressure; patient-reported discomfort by visual analogue scale [VAS]), air blast (VAS) and global subjective sensitivity (VAS). Oral tolerance was monitored throughout the study. At 2 weeks, subjects treated with the positive control and LADS mouthrinse showed significant reductions (pSensodyne Original) significantly reduced sensitivity compared with the negative control (Crest toothpaste alone), thus validating the study. The LADS mouthrinse (1.4% KO mouthrinse) significantly reduced sensitivity compared with the negative control, suggesting that LADS mouthrinse was responsible for the clinical effect observed. The treatments were well tolerated. To our knowledge, this is the first randomised clinical study to demonstrate the efficacy of a KO-containing mouthrinse (LADS) in relieving dentinal sensitivity. Copyright © 2013 Elsevier Ltd. All rights reserved.

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

    Directory of Open Access Journals (Sweden)

    Gajofatto A

    2015-12-01

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

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

    Directory of Open Access Journals (Sweden)

    Zhi-Hua Peng

    2013-08-01

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

  17. Impact of acute otitis media pathogen shifts on the clinical efficacy of several antibiotics: a therapeutic outcomes model.

    Science.gov (United States)

    Canut, A; Martin-Herrero, J E; Maortua, H; Labora, A; Isla, A; Rodriguez-Gascon, A

    2009-08-01

    The aim of this study was to predict the clinical efficacy of different antimicrobials in the treatment of patients with acute otitis media (AOM), before and after the change in the proportion of middle ear pathogens observed after the introduction of the new conjugated heptavalent penumococcal vaccine (pPCV-7). The therapeutic Outcomes model was used to predict the likelihood of clinical success. According to this mathematical model the obtained rank order of predicted clinical efficacy was similar in the pre-PVC7 period and the post-PVC period. The results suggest that ceftriaxone and amoxicillin/clavulanate are the antibiotics with the highest predicted clinical efficacy, whereas cefaclor, azithromycin, erythromycin and clarithromycin are those with the lowest predicted clinical efficacy. The differences between antibiotics with good and those with low antibacterial activity were greater when only cases of bacterial AOM were considered. Antibiotics for which the highest clinical efficacy was predicted should maximize the likelihood of cure in outpatient antibiotic treatment of AOM.

  18. Efficacy and utility of phone call follow-up after pediatric general surgery versus traditional clinic follow-up.

    Science.gov (United States)

    Fischer, Kevin; Hogan, Virginia; Jager, Alesha; von Allmen, Daniel

    2015-01-01

    Typical follow-up for surgical procedures consists of an interim history and brief focused physical examination. These appointments occupy clinic resources, require a time investment by the family, and rarely identify problems. Previous studies have demonstrated the safety of a postoperative phone call. Compare a traditional in-person clinic postoperative visit with postoperative phone call follow-up regarding patient satisfaction, rate of successful follow-up, and clinic resource utilization in a large academic practice. A retrospective review of charts of patients who underwent select surgical procedures, along with a review of the clinic schedule for the same time period. Efficacy, patient/family satisfaction, and impact on the clinic. Families were contacted by telephone two weeks after select surgical procedures to assess for complications and questions. Cohorts of patients six months before and six months after implementation were assessed for main outcome measures. Before implementation, 55.5% of patients (427/769) who had one of the select surgical procedures were seen in the clinic postoperatively, and 62.6% (435/695) had a successful postoperative phone call follow-up. There were also 1090 overall scheduled postoperative appointments. Six months after implementation, overall postoperative appointments decreased 35.5% to 703. Overall, postoperative-scheduled visits decreased by 6% compared with new visits and other general follow-up visits, which each increased by 3%. A satisfaction survey revealed that 93% of patients (n = 231) were highly satisfied with the process. A hospital cost analysis suggested an 89% cost savings ($101.75 per patient for clinic visit vs $12.50 per patient for phone call follow-up). Postoperative phone call follow-up is an effective tool that improves patient and physician efficiency and satisfaction.

  19. Clinical Efficacy of Artemether-Lumefantrine in Congolese Children with Acute Uncomplicated Falciparum Malaria in Brazzaville

    Directory of Open Access Journals (Sweden)

    Mathieu Ndounga

    2012-01-01

    Full Text Available The Republic of the Congo adopted artemisinin-based combination therapies (ACTs in 2006: artesunate-amodiaquine and artemether-lumefantrine as the first-line and second-line drugs, respectively. The baseline efficacy of artemether-lumefantrine was evaluated between March and July 2006 in Brazzaville, the capital city of Congo. Seventy-seven children aged between 6 months and 10 years were enrolled in a nonrandomized study. The children were treated under supervision with 6 doses of artemether-lumefantrine and followed up for 28 days in accordance with the 2003 World Health Organization guideline. Pretreatment (i.e., day 0 and recrudescent Plasmodium falciparum isolates between day 14 and day 28 were compared by the polymerase chain reaction to distinguish between true recrudescence and reinfection. The overall cure rate on day 28 was 96.9% after PCR correction. Reported adverse effects included pruritus and dizziness. Artemether-lumefantrine was highly efficacious in Brazzaville.

  20. Clinical efficacy and safety of Chinese herbal medicine for Wilson's disease: a systematic review of 9 randomized controlled trials.

    Science.gov (United States)

    Wang, Yan; Xie, Cheng-long; Fu, Deng-lei; Lu, Lin; Lin, Yan; Dong, Qi-qian; Wang, Xiao-tong; Zheng, Guo-qing

    2012-06-01

    Wilson's disease is an autosomal recessive disorder of copper metabolism. Despite being treatable, there is no universally accepted treatment regimen. Currently, various Chinese herbal medicines (CHMs) are widely used in the treatment of Wilson's disease in China, but there is a lack of reliable scientific evidence for the effectiveness of such therapies. The objective of this systematic review is to assess the clinical efficacy and safety of CHM as an alternative or/and adjuvant therapy for Wilson's disease. A systematic literature search in different medical databases was performed to identify randomized controlled trials comparing CHM as monotherapy or CHM as adjuvant therapy with western conventional medical therapy in the treatment of Wilson's disease. A total of 687 participants were included in nine eligible studies. The main findings are that CHM as monotherapy or adjuvant therapy for Wilson's disease may be able to improve the clinical symptoms, to promote the urinary copper excretion, to ameliorate liver function and/or liver cirrhosis, and has fewer adverse effects in comparison with western conventional medication. Furthermore, CHM generally appeared to be safe and well tolerated in patients with Wilson's disease. However, the evidence presented in this review are insufficient to warrant a clinical recommendation due to the generally low methodological quality of the included studies. In conclusion, CHM seems to be beneficial and safe for Wilson's disease, but high-quality evidences are still needed to further evaluate this therapy. Therefore, additional well-designed, randomized, placebo-controlled clinical trials are needed.

  1. To evaluate the efficacy of ultrasonography compared to clinical diagnosis, radiography and histopathological findings in the diagnosis of maxillofacial swellings

    Energy Technology Data Exchange (ETDEWEB)

    Pallagatti, Shambulingappa, E-mail: dr.shambulingappa@gmail.com [Department of Oral Medicine and Radiology, M.M. College of Dental Sciences and Research, Mullana, Ambala, Haryana (India); Sheikh, Soheyl; Puri, Nidhi; Mittal, Amit; Singh, Balwinder [Department of Oral Medicine and Radiology, M.M. College of Dental Sciences and Research, Mullana, Ambala, Haryana (India)

    2012-08-15

    Aim: To evaluate the efficacy of Ultrasonography compared to clinical diagnosis, radiography and histopathological findings in the diagnosis of maxillofacial swellings. Material and methods: The study was conducted on forty-five patients with maxillofacial swellings. The clinical diagnosis, radiographic diagnosis and ultrasonographic diagnosis were made which was compared to the histopathological diagnosis. The maxillofacial swellings included cystic lesions, benign swellings, malignant swellings, lymphadenopathies and abscesses and space infections. Results: The diagnostic accuracy and contingency coefficient was evaluated considering histopathology as gold standard. The diagnostic accuracy of ultrasound was found to be 92.30% in the diagnosis of cystic lesions, 87.5% in benign tumors, 81.8% in malignant tumors, 100% in lymphadenopathies and 90% in space infections and abscesses. The contingency coefficient of 0.934 was obtained when ultrasonography was compared to the histopathology, which was highly significant. Similar significant results were obtained comparing ultrasonography with clinical diagnosis (0.895) and radiographic diagnosis (0.889). Conclusion: Ultrasonography provides accurate imaging of the head and neck region and provides information about the nature of the lesion, its extent, and relationship with the surrounding structures. As the conventional and digital radiography enable the diagnosis of the presence of the disease, but do not give any indication of its nature. So, together with clinical and histopathological examinations, real time ultrasound imaging works out as a valuable adjunct in the diagnosis of orofacial swellings.

  2. Science self-efficacy in tenth grade Hispanic female high school students

    Science.gov (United States)

    Miller, Maria Decanio

    Historical data have demonstrated an underrepresentation of females and minorities in science, technology, engineering, and mathematics (STEM) professions. The purpose of the study considered the variables of gender and ethnicity collectively in relationship to tenth grade Hispanic females' perception of their self-efficacy in science. The correlation of science self-efficacy to science academic achievement was also studied. Possible interventions for use with female Hispanic minority populations might help increase participation in STEM field preparation during the high school career. A population of 272 students was chosen through convenience sampling methods, including 80 Hispanic females. Students were administered a 27-item questionnaire taken directly from the Smist (1993) Science Self-efficacy Questionnaire (SSEQ). Three science self-efficacy factors were successfully extracted and included Academic Engagement Self-efficacy (M=42.57), Laboratory Self-efficacy (M=25.44), and Biology Self-efficacy ( M=19.35). Each factor showed a significant positive correlation ( pself-efficacy perceptions. Asian/Pacific and Native American females had higher self-efficacy mean scores as compared to White, Black and Hispanic females on all three extracted science self-efficacy factors. Asian/Pacific females had the highest mean scores. No statistically significant correlations were found between science-self-efficacy and a measure of science achievement. Two high-ability and two low-ability Hispanic females were randomly chosen to participate in a brief structured interview. Three general themes emerged. Classroom Variables, Outside School Variables, and Personal Variables were subsequently divided into sub themes influenced by participants' views of science. It was concluded that Hispanic female science self-efficacy was among the subgroups which self-scored the lowest. Asian/Pacific and Native American females fared better than White, Black, and Hispanic female counterparts

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

    NARCIS (Netherlands)

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

    2008-01-01

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

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

    NARCIS (Netherlands)

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

    2008-01-01

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

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

    NARCIS (Netherlands)

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

    2008-01-01

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

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

    NARCIS (Netherlands)

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

    2008-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Shuo Zhang

    2013-01-01

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

  8. Is deqi an indicator of clinical efficacy of acupuncture? A systematic review.

    Science.gov (United States)

    Zhang, Shuo; Mu, Wei; Xiao, Lu; Zheng, Wen-Ke; Liu, Chun-Xiang; Zhang, Li; Shang, Hong-Cai

    2013-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Safieh Mohebitabar

    2017-04-01

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

  10. Clinical Models to Compare the Safety and Efficacy of Inhaled Corticosteroids in Patients with Asthma

    Directory of Open Access Journals (Sweden)

    Krishnan Parameswaran

    2003-01-01

    Full Text Available There is no consensus on the methods to compare the clinical efficacy of different inhaled corticosteroids. A comparison needs to be made in terms of relative potency, and studies should include two-, or preferably, three-dose comparisons. A number of clinical models and outcomes are available; they have their relative advantages and disadvantages. While measurements of symptoms and spirometry are easy and readily available, they show a flat dose-response relationship. Measurements of bronchial hyper-responsiveness to exercise and adenosine monophosphate, allergen-induced airway responses, and measurements of inflammation in sputum and exhaled air show steep dose-response relationships, particularly to low doses of inhaled steroids. An uncontrolled asthma model followed by stabilization with a short course of additional steroid, with measurements of airway responsiveness and airway inflammation, in a crossover study seems more promising than the other models. Drug deposition studies and mathematical modelling of drug pharmacokinetics in the airway may provide complementary information to clinical drug relative potency studies. Fine particle dose and emitted doses, rather than the nominal dose, should be considered in the estimation of clinical and systemic effects, respectively. When a second entry (generic drug is being evaluated in comparison with the innovator drug (same compound and same device, it may be appropriate to consider accepting a generic as bioequivalent if it satisfies pharmaceutical equivalence.

  11. Leading Public Service Organisations: How to obtain high employee self-efficacy and organisational performance

    DEFF Research Database (Denmark)

    Jacobsen, Christian Bøtcher; Andersen, Lotte Bøgh

    2016-01-01

    Concerns are sometimes raised that transactional leadership harms public organisations’ performance, because demands thwart employees’ self-efficacy. However, the opposite may be argued – conditional rewards strengthen feelings of competence because they provide positive feedback on performance. We...... study ninety-two high school principals’ reported use of contingent rewards and sanctions and self-efficacy among their 1,932 teachers. The results indicate that contingent rewards strengthen self-efficacy, and that sanctions are not negatively related with self-efficacy or performance. Furthermore......, the teachers’ self-efficacy can be linked positively to organisational performance. This suggests that rewards can be an important tool for managers in the public sector....

  12. Leading public service organizations: How to obtain high employee self-efficacy and organizational performance

    DEFF Research Database (Denmark)

    Jacobsen, Christian Bøtcher; Andersen, Lotte Bøgh

    2017-01-01

    Concerns are sometimes raised that transactional leadership harms public organisations’ performance, because demands thwart employees’ self-efficacy. However, the opposite may be argued – conditional rewards strengthen feelings of competence because they provide positive feedback on performance. We...... study ninety-two high school principals’ reported use of contingent rewards and sanctions and self-efficacy among their 1,932 teachers. The results indicate that contingent rewards strengthen self-efficacy, and that sanctions are not negatively related with self-efficacy or performance. Furthermore......, the teachers’ self-efficacy can be linked positively to organisational performance. This suggests that rewards can be an important tool for managers in the public sector....

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

    Directory of Open Access Journals (Sweden)

    Natesan SK

    2016-12-01

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

  14. Clinical efficacy and safety of parenteral nutrition in adolescent girls with anorexia nervosa.

    Science.gov (United States)

    Diamanti, A; Basso, M S; Castro, M; Bianco, G; Ciacco, E; Calce, A; Caramadre, A M; Noto, C; Gambarara, M

    2008-02-01

    Anorexia nervosa (AN) is a common chronic disorder characterized by severe malnutrition and psychological disturbances. Parenteral nutrition (PN) is not usually used in nutritional rehabilitation of AN. The aim of our study was to retrospectively evaluate the indications, clinical efficacy, and safety of PN as assessed by short- and long-term outcomes in AN inpatient girls. During the last 10 years a total of 198 inpatients were included in our study: 104 (53%) received oral and parenteral refeeding (group A) and 94 (47%) oral refeeding alone (group B). For each nutritional treatment, clinical efficacy was evaluated by short- and long-term outcomes, and safety was assessed by complication rate. Short-term outcome assessment indicated weekly weight gain and maximum caloric intake to be higher in PN-treated patients. Long-term outcome evaluation showed rehospitalization and recovery rate to be similar in the two groups, but failure of first nutritional rehabilitation requiring PN significantly greater in group B (17.5%) than in group A (3%) (p = .01). The number of complications was significantly higher in group A than in group B (p = .004), although all complications resolved. Among all nutritional rehabilitation strategies, PN offers an alternative and safe way to successfully treat AN patients. Presence of clinical complications and reduced compliance with individual, group, and family therapy seem to be the main indications for PN, as it promptly improves nutritional status. At pediatric and adolescent ages, psychological disturbances can also contraindicate the use of enteral nutrition, and therefore represent an additional indication for PN.

  15. Clinical efficacy of lamotrigien in combined with valproic acid in the treatment of epilepsy

    Institute of Scientific and Technical Information of China (English)

    Yu-Mei Wen; Xiu-Juan Liu; Xiao-Yu Liu; Ming-Xia Xu

    2016-01-01

    Objective:To observe the clinical efficacy of lamotrigien (LTG) in combined with valproic acid (VAP) in the treatment of epilepsy and their effects on lipid metabolism indicators and recognition function.Methods:A total of 80 patients with epilepsy who were admitted in our hospital from January, 2014 to January, 2015 were included in the study and randomized into the observation group and the control group with 30 cases in each group. The patients in the observation group were given LTG in combined with VAP, while the patients in the control group were only given VAP. The clinical efficacy in the two groups was compared. Changes of various lipid indicators and recognition function in the two groups were detected.Results:The total effective rate in the observation group was significantly higher than that in the control group. The attentiveness, memory delay, and MOCA score after treatment in the observation group were significantly elevated when compared with before treatment, and were significantly higher than those in the control group. The comparison of implementing competence before and after treatment in the observation group was not statistically significant . The levels of TC, TG, LDL-C, and HDL-C after treatment in the observation group were not significantly different from those before treatment. The levels of TC, TG, and LDL-C after treatment in the control group were significantly elevated when compared with before treatment and were significantly higher than those in the observation group in the same period.Conclusions:LTG in combined with VAP can effectively control the seizure frequency in patients with epilepsy with a small effect on lipid metabolism, and significantly improve the cognition ability; therefore, it deserves to be widely recommended in the clinic.

  16. Clinical efficacy of entecavir in HBeAg-negative chronic hepatitis B with compensated cirrhosis

    Directory of Open Access Journals (Sweden)

    HAN Benli

    2016-08-01

    Full Text Available ObjectiveTo investigate the clinical efficacy of 96-week entecavir (ETV treatment for HBeAg-negative chronic hepatitis B patients with compensated cirrhosis, as well as its effect on patients with different HBV DNA loads. MethodsA total of 118 chronic hepatitis B patients with compensated cirrhosis who visited Xiangyang Hospital of Traditional Chinese Medicine from January 2009 to June 2013 were enrolled and all had Child-Pugh class A cirrhosis. According to HBV DNA load, these patients were divided into high-load group (group A, HBV DNA≥105 copies/ml and low-load group (group B, HBV DNA<105 copies/ml. All the patients were treated with ETV 0.5 mg/d for 96 weeks. Child-Pugh score was used to evaluate liver function before and after treatment, and the changes in alanine aminotransferase (ALT, albumin (Alb, and total bilirubin (TBil after treatment were observed. Hyaluronic acid (HA, α2-macroglobulin, and liver stiffness measurement (LSM were used to evaluate liver fibrosis. The t-test was used for comparison between groups, and a repeated-measures analysis of variance was used for comparison within one group and between groups at different time points. Chisquare test was applied for comparison of categorical data between the two groups. ResultsThe two groups showed significant reductions in ALT, Alb, and TBil at weeks 12 and 24 of treatment (all P<0.05, and the ALT normalization rate and HBV DNA clearance rate at weeks 24 and 48 of treatment showed significantly differences between the two groups (χ2=9.241,6.428,11.134,5.139,all P<0.05. Both groups showed significant reductions in HA, α2-macroglobulin, and LSM after treatment (t=2.648,1.921,4.018,3.166,2.136,3.461,all P<0.05. The incidence rates of complications such as variceal bleeding, ascites, and hepatocellular carcinoma showed no significant differences between the two groups (all P>0.05. ConclusionIn HBeAg-negative chronic hepatitis B patients with

  17. Efficacy of a grapefruit extract on head lice: a clinical trial.

    Science.gov (United States)

    Abdel-Ghaffar, Fathy; Semmler, Margit; Al-Rasheid, Khaled; Klimpel, Sven; Mehlhorn, Heinz

    2010-01-01

    Twenty children aging 2-9 years old--four boys with short hair and 16 girls with long hair--were included in a clinical test on the efficacy of a product against head lice (Pediculus humanus capitis). Their hair were exposed to Licatack, which is a recently developed new anti-louse medicinal product containing extracts of grapefruits besides high quality shampoo components. Prior to this field trial, the product Licatack was tested dermatologically to be skin safe receiving the grade "very good". The children's mothers combed the kids prior to the start of the test in order to confirm that they were all lice-infested. The obtained lice were used for in vitro tests. All children were heavily infested. After combing and preservation of the living lice, the hair was wet with tap water. Then, 50 ml of the Licatack shampoo was placed onto the top of each child's head. Then, the mothers distributed the rather fluid product all over the hair thoroughly from their base at the skin until the free end. During this process, a type of massage, the product became foamy and it was easily recognized where the product covered the hair, thus, avoiding untreated spots. The hair of half of the treated children were washed with tap water after 10 min of exposition; while in the other half of the children, the exposition period was prolonged to 20 min before washing. When combing the kids with a metal louse comb after the washing, the lice were found immobile and they did not recover during the following observation period of 4 h. Only two lice from the group with an exposition time of only 10 min showed some slight leg movements after they had been combed off, but they died within the next 2 h. Thus, this new anti-louse medicinal product has a very quick and efficient activity besides its advantages of being non-inflammable, skin safe, and nice smelling. None of the kids claimed any burning at the skin or other side effects, although the skin showed, prior to treatment, lots of scars

  18. Meta-analysis of clinical and preclinical studies comparing the anticancer efficacy of liposomal versus conventional non-liposomal doxorubicin.

    Science.gov (United States)

    Petersen, Grant H; Alzghari, Saeed K; Chee, Wayne; Sankari, Sana S; La-Beck, Ninh M

    2016-06-28

    While liposome-mediated delivery of cytotoxic chemotherapy has been shown to significantly enhance drug tolerability in patients as compared to the conventional formulation, the fundamental question remains whether they also improve anticancer efficacy. Thus, we performed a systematic literature search for randomized clinical trials directly comparing efficacy of liposomal cytotoxic chemotherapy versus their equivalent conventional formulation. The search yielded 14 clinical trials (8 anthracycline, 4 cisplatin, 1 paclitaxel, 1 irinotecan) that meet inclusion criteria, with a total of 2589 patients. We found that efficacy in patients was not different between liposomal and conventional chemotherapy as assessed by objective response (odds ratio 1.03; 95% confidence interval [CI] 0.82-1.30), overall survival (hazard ratio [HR] 1.05; 95% CI 0.95-1.17), and progression free survival rates (HR 1.01; 95% CI, 0.92-1.11). Subgroup analyses of only the anthracycline trials also did not show any efficacy advantage for the liposomal formulation. Since pegylated liposomal doxorubicin (PLD) was the most prevalent formulation in these clinical trials, we also performed a meta-analysis of 11 preclinical studies comparing efficacy of PLD and conventional doxorubicin in tumor-bearing mice. In contrast with clinical results, animal studies showed significantly increased survival in mice treated with PLD compared to conventional doxorubicin (HR 0.39; 95% CI 0.27-0.56). We discuss the possible reasons why the pharmacological advantages of carrier-mediated chemotherapy did not translate into enhanced clinical efficacy including the role of the enhanced permeability and retention (EPR) effect and the tumor microenvironment, the optimal dosing regimen for carrier-mediated agents, and the lack of standardization in the conduct and reporting of preclinical studies evaluating anticancer efficacy of these agents. Our study shows that the full clinical potential of carrier-mediated drugs

  19. [Efficacy of high-frequency cinematography in diagnosis of dysphagia].

    Science.gov (United States)

    Oelerich, M; Mai, R; Müller-Miny, H; Peters, P E

    1995-10-01

    Dysphagia is a common symptom in clinical practice. Due to the broad spectrum of underlying diseases many disciplines are involved in the therapy and diagnosis of dysphagia, where radiology plays a central role. The radiologist is confronted with different diagnostic problems and has to choose the most appropriate type of investigation. In many cases no organic disorder can be demonstrated by clinical examination, endoscopy or conventional radiological techniques. In this setting cineradiography is an outstanding tool for finding functional or structural changes in the swallowing chain. This study underlines the efficiency of cineradiography in the diagnosis of dysphagia.

  20. From a Traditional Medicinal Plant to a Rational Drug: Understanding the Clinically Proven Wound Healing Efficacy of Birch Bark Extract

    Science.gov (United States)

    Ebeling, Sandra; Naumann, Katrin; Pollok, Simone; Wardecki, Tina; Vidal-y-Sy, Sabine; Nascimento, Juliana M.; Boerries, Melanie; Schmidt, Gudula; Brandner, Johanna M.; Merfort, Irmgard

    2014-01-01

    Background Birch bark has a long lasting history as a traditional medicinal remedy to accelerate wound healing. Recently, the efficacy of birch bark preparations has also been proven clinically. As active principle pentacyclic triterpenes are generally accepted. Here, we report a comprehensive study on the underlying molecular mechanisms of the wound healing properties of a well-defined birch bark preparation named as TE (triterpene extract) as well as the isolated single triterpenes in human primary keratinocytes and porcine ex-vivo wound healing models. Methodology/Principal Findings We show positive wound healing effects of TE and betulin in scratch assay experiments with primary human keratinocytes and in a porcine ex-vivo wound healing model (WHM). Mechanistical studies elucidate that TE and betulin transiently upregulate pro-inflammatory cytokines, chemokines and cyclooxygenase-2 on gene and protein level. For COX-2 and IL-6 this increase of mRNA is due to an mRNA stabilizing effect of TE and betulin, a process in which p38 MAPK and HuR are involved. TE promotes keratinocyte migration, putatively by increasing the formation of actin filopodia, lamellipodia and stress fibers. Detailed analyses show that the TE components betulin, lupeol and erythrodiol exert this effect even in nanomolar concentrations. Targeting the actin cytoskeleton is dependent on the activation of Rho GTPases. Conclusion/Significance Our results provide insights to understand the molecular mechanism of the clinically proven wound healing effect of birch bark. TE and betulin address the inflammatory phase of wound healing by transient up-regulation of several pro-inflammatory mediators. Further, they enhance migration of keratinocytes, which is essential in the second phase of wound healing. Our results, together with the clinically proven efficacy, identify birch bark as the first medical plant with a high potential to improve wound healing, a field which urgently needs effective remedies

  1. Efficacy of Two Streptokinase Formulations in Acute Myocardial Infarction: A Double-Blind Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Navid Paydari

    2009-03-01

    Full Text Available Background: We sought to evaluate the efficacy and safety of the different trade forms of streptokinase available in our country, namely Heberkinasa (Heberbiotec, Havana, Cuba and Streptase (Aventis Behring GmbH, Marburg, Germany. Methods: We conducted a double-blind randomized clinical trial to compare the two streptokinase formulations, i.e. Heberkinasa (HBK or Streptase (STP, in patients with acute myocardial infarction who needed thrombolysis. Thrombolysis success was evaluated angiographically and/or clinically. Clinical follow-up was done 30 days after thrombolysis. Results: We randomly allocated 221 patients with a mean age of 56.9±10.8 years (males: 88.2% to HBK (n=119 and STP (n=102 groups. Baseline clinical and demographic characteristics were similar between the two groups, and the two groups were not significantly different in terms of door-to-needle and pain-to-needle intervals. The rate of complications was not significantly different between the groups (44.1% [HBK] vs. 42% [STP]. Angiography was done for 158 (71.5 % patients in the first 24 hours (9% and in the first 72 hours (38.8% after thrombolysis. Lesion morphology and lesion/patient ratio were not significantly different between the two groups (1.87[HBK] vs. 1.67[STP]. The two groups were similar with respect to angiographic patency rate (67.5% [HBK] vs. 67.6% [STP]. The study groups were also similar as regards clinical outcome and complications of both streptokinase formulations. Conclusion: The present study demonstrated that Heberkinasa is as effective and as safe as a standard streptokinase, namely Streptase, in a clinical setting.

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

    Science.gov (United States)

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

    2016-02-01

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

  3. Self-Efficacy as a Predictor of High School Students’ Subjective Well-Being

    Directory of Open Access Journals (Sweden)

    Bülent Baki TELEF

    2013-07-01

    Full Text Available The purpose of this study is to determine whether subjective well-being of high school students is predicted by their academic, social, and emotional self-efficacy. The sample of this study consisted of 311 high school students of whom 64% (n= 199 were girls and 36% (n= 112 were boys. Data were collected by the Self-Efficacy Scale for Children, the Positive and Negative Experience Scale, and the Life Satisfaction Scale and analyzed through multiple regression analysis. Results showed that high school students’ academic, social, and emotional self-efficacy explained 19% of variance in their subjective well-being and predicted their subjective well-being. Activities performed by school counselors to increase students’ academic, social, and emotional self-efficacy levels are thought to contribute to their subjective well-being.

  4. Investigations of efficacy of intramammary applied antimicrobials and glucocorticosteroides in the treatment of subclinical and clinical mastitis in cows

    Directory of Open Access Journals (Sweden)

    Vakanjac Slobodanka

    2013-01-01

    Full Text Available Inflammation of the mammary gland, mastitis in cows, presents one of the most acute problems in intensive dairy production, inflicting huge economic losses. In the course of one year, 80 samples were taken at investigated farms from udder quarters of cows with clinical mastitis and 160 samples from udder quarters of cows with subclinical mastitis. The efficacy of three preparations, A, B, and C, was examined in the treatment of clinical and subclinical mastitis in cows. The investigations indicate that antibiotic preparation A (neomycin, polimixine B, oleandomycin and prednisolone exhibited a greater efficacy in the treatment of clinical mastitis caused by Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus uberis and Micrococcus sp., but a smaller efficacy in the treatment of subclinical mastitis caused by Staphylococcus aureus. Preparation B (amoxicillin, clavulanic acid and prednisolone exhibited a higher efficacy in the treatment of clinical mastitis caused by Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus uberis and Micrococcus, but a weaker effect in the treatment of subclinical mastitis caused by Staphylococcus aureus. Preparation C (procaine penicillin G, streptomycin, neomycin sulfate and prednisolone acetate exihibited efficacy in the treatment of clinical and subclinical mastitis caused by Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus uberis, Micrococcus, Staphylococcus aureus and Esherichie coli. [Projekat Ministarstva nauke Republike Srbije, br. III 46002: Molekularno-genetička i ekofiziološka istraživanja u zaštiti autohtonih animalnih genetičkih resursa, očuvanju dobrobiti, zdravlja i reprodukcije gajenih životinja i proizvodnji bezbedne hrane

  5. Relationships Between Clinical Decision-Making Patterns and Self-Efficacy and Nursing Professionalism in Korean Pediatric Nurses.

    Science.gov (United States)

    Choi, Miyoung; Kim, Jisoo

    2015-01-01

    As pediatric nurses must make decisions on a regular basis when caring for hospitalized children, clinical decision-making abilities are necessary in this profession. In the present study, we explored clinical decision-making patterns and their association with self-efficacy and nursing professionalism in pediatric nurses. We surveyed 173 pediatric nurses and analyzed the relationships between their clinical decision-making patterns and self-efficacy and nursing professionalism. Factor analysis identified 5 clinical decision-making patterns: patient-family-nurse collaborative (PNC), individual patient-oriented (IP), nurse model-oriented (NM), pattern-oriented intuitive (PI), and nursing knowledge-oriented (NK). The most frequently observed clinical decision-making pattern was the PNC. The self-efficacy and nursing professionalism were found to be higher in pediatric nurses using the IP and NM, and were lower for those using the PNC. Thus, the present results suggest that pediatric nurses' clinical decision-making patterns are influenced by nursing professionalism and self-efficacy. Therefore, intervention programs focusing on these variables might improve clinical decision-making in pediatric nurses. Copyright © 2015 Elsevier Inc. All rights reserved.

  6. Clinical and bacteriological efficacies of sitafloxacin against community-acquired pneumonia caused by Streptococcus pneumoniae: nested cohort within a multicenter clinical trial.

    Science.gov (United States)

    Fujita, Jiro; Niki, Yoshihito; Kadota, Jun-Ichi; Yanagihara, Katsunori; Kaku, Mitsuo; Watanabe, Akira; Aoki, Nobuki; Hori, Seiji; Tanigawara, Yusuke; Cash, Haley L; Kohno, Shigeru

    2013-06-01

    We evaluated the clinical and bacteriological efficacy of oral sitafloxacin (STFX) in clinically diagnosed community-acquired pneumonia (CAP) caused by Streptococcus pneumoniae. Additionally, we cultured these patient samples to test the minimal inhibitory concentrations (MICs) of levofloxacin (LVFX), moxifloxacin (MFLX), STFX, and penicillin G (PCG), as well as identified mutations in the quinolone resistance determinant regions (QRDRs) in LVFX-resistant strains. This study is a nested cohort from a prospective, multicenter clinical trial consisting of 139 patients with community-acquired pneumonia (CAP), from which 72 were included in this study. After diagnosis of CAP caused by S. pneumoniae, STFX (50 mg twice daily, or 100 mg once daily) was orally administered for 7 days. Sixty-five patient sputum samples were then cultured for MIC analysis. In a LVFX-resistant strain that was identified, mutations in the QRDRs of the gyrA, gyrB, parC, and parE genes were examined. Of 72 patients eligible for this study, S. pneumoniae was successfully cultured from the sputum of 65 patients, and only 7 patients were diagnosed by urinary antigen only. Clinical improvement of CAP was obtained in 65 of the 69 clinically evaluable patients (65/69, 94.2 %). Eradication of S. pneumoniae was observed in 62 patients of the 65 bacteriologically evaluable patients (62/65, 95.4 %). Additionally, STFX showed the lowest MIC distribution compared with LVFX, MFLX, and PCG, and no major adverse reactions were observed. STFX treatment in patients with CAP caused by S. pneumoniae was found to be highly effective both clinically (94.2 %) and bacteriologically (95.4 %).

  7. Amphotericin B and its new formulations: pharmacologic characteristics, clinical efficacy, and tolerability.

    Science.gov (United States)

    Tiphine, M; Letscher-Bru, V; Herbrecht, R

    1999-12-01

    candidiasis. Several comparative studies have confirmed that this formulation has similar or superior efficacy relative to amB in various fungal infections and also in the empirical treatment of febrile neutropenia. Renal and general tolerability is excellent. The optimal dosing remains unclear but is generally between 3 and 5 mg/kg/day. A double-blind trial comparing the tolerance of liposomal amB and ABLC demonstrated that both infusion-related events and nephrotoxicity were significantly lower for liposomal amB. In sum, the new lipid formulations of amB are effective in various invasive fungal infections. The three formulations exhibit reduced nephrotoxicity compared with conventional amB. Large-scale comparative clinical trials may clarify issues of relative efficacy in various forms of mycotic infections.

  8. Comparison of the efficacy of chemicomechanical caries removal with conventional methods - a clinical study.

    Science.gov (United States)

    Goomer, Pallvi; Jain, R L; Kaur, Harsimrat; Sood, Rahul

    2013-06-01

    There has been considerable interest in developing alternative methods of cavity preparation and caries removal due to disadvantages of using traditional rotating instruments which can result in heat, pressure ,dentin dessication, vibration and pain. Hence, the aim of this study was to compare different methods of caries removal in terms of efficacy, time taken and pain during caries removal. A total of 150 carious teeth were selected among 80 children of 6-10 years of age, following Radiovisiography (RVG) according to specific inclusion criteria and caries removal was done by hand instruments ,air rotor and carisolv respectively. The efficacy, time taken and pain threshold were evaluated during caries removal by Ericson D et al scale, Time scale (Raber H et al), visual analogue scale (Nayak R et al) and verbal pain scale (Cinzia Brunelli et al) respectively. Data was collected and statistically analysed. Mean value of time taken for removal of caries by carisolv group (580.26 sec) was found to be significantly higher as compared to conventional hand excavation and air rotor. Air rotor was found to be the most efficient method (mean value 1.20). Mean value of pain perception was significantly less with carisolv (0.82) as compared to air rotor and hand instrument. It was concluded that chemicomechanical removal of caries with Carisolv was found to be effective measure of caries removal and could be considered as viable alternatives to painful procedures like airotor in management of dental caries especially in children. How to cite this article: Goomer P, Jain R L, Kaur H, Sood R. Comparison of the Efficacy of Chemicomechanical Caries Removal with Conventional Methods - A Clinical Study. J Int Oral Health 2013; 5(3):42-47.

  9. [Clinical efficacy on peripheral facial paralysis at acute stage treated with opposing needling technique].

    Science.gov (United States)

    Li, Ying; Zhang, Zhongyi; Chen, Yuelai; Zong, Lei; Li, Jing; Tao, Ying; Zeng, Liang; Hou, Wenguang

    2015-01-01

    To compare the differences in clinical efficacy on peripheral facial paralysis at acute stage between the opposing needling technique and routine acupuncture at the affected side so as to provide the evidence on the acupuncture treatment for peripheral facial paralysis at acute stage. Forty patients were rando- mized into an opposing needling technique group (19 cases) and an affected side needling technique group (21 cases). The basic medication was same in the two groups. The acupoints were Fengchi (GB 20), Yangbai (GB 14) to Yuyao (EX-HN 4) (penetrating needling method), Jingming (BL 1), Chengqi (ST 1), Xiaguan (ST 7), Jiache (ST 6) to Dicang (ST 4), Hegu (LI 4) and Zusanli (ST 36). In supplementation, in the opposing needling technique group, the acupoints were stimulated on the face of healthy side. In the affected side needling technique group, the acupoints were stimulated on the face of the affected side. The treatment was given three times a week, for 4 weeks. House-Brackmann (H-B) facial nerve function assessment was used to evaluate facial nerve function before and after treatment in the patients of the two groups. The efficacy was compared between the two groups. The facial nerve function was recovered in the two groups and the total effective rate was 100.0% in the two groups (P>0.05). The curative rate was 68.4% (13/19) in the opposing needling technique group and better than 47.6% (10/21) in the affected side needling technique group (Pfacial nerve function in peripheral facial paralysis at acute stage and apparently shortens the curative time. The efficacy is better than that in acupuncture on the affect- ed side of the face.

  10. Analysis of clinical efficacy, side effects, and laboratory changes among patients with acne vulgaris receiving single versus twice daily dose of oral isotretinoin.

    Science.gov (United States)

    Ahmad, Hesham M

    2015-01-01

    Acne vulgaris is a debilitating disorder and requires proper treatment. This work evaluates the clinical efficacy, side effects, and laboratory changes of serum lipids and liver function during oral isotretinoin therapy for acne vulgaris, comparing single versus twice daily dose. Fifty-eight patients with acne vulgaris were included and randomized into group I (26 patients), who received once daily dose, and group II (32 patients), who received twice daily dose of oral isotretinoin. Global acne scoring system was used to evaluate acne severity and post-treatment improvement. Both regimens resulted in highly significant clinical improvement of acne with no significant difference. However, side effects were significantly more common among patients of group I. Both regimens caused mild rise of serum cholesterol, alanine transaminase (ALT), and aspartate aminotransferase (AST) with more prominent rise of triglycerides especially with twice daily dose. Oral isotretinoin is a very effective treatment for acne vulgaris with no statistically significant difference in clinical efficacy between once and twice daily doses. However, dividing dose to twice per day might cause fewer incidence of side effects without reducing clinical efficacy. The drug causes mild clinically insignificant rise of serum cholesterol, triglycerides, AST, and ALT.

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

    OpenAIRE

    Yoshiki Matsuda; Keita Sugiura; Takashi Hashimoto; Akane Ueda; Yoshihiro Konno; Yoshiyuki Tatsumi

    2016-01-01

    Onychomycosis is difficult to treat topically due to the deep location of the infection under the densely keratinized nail plate. In order to obtain an in vitro index that is relevant to the clinical efficacy of topical anti-onychomycosis drugs, we profiled five topical drugs: amorolfine, ciclopirox, efinaconazole, luliconazole, and terbinafine, for their nail permeabilities, keratin affinities, and anti-dermatophytic activities in the presence of keratin. Efinaconazole and ciclopirox permeat...

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

    OpenAIRE

    Yoshiki Matsuda; Keita Sugiura; Takashi Hashimoto; Akane Ueda; Yoshihiro Konno; Yoshiyuki Tatsumi

    2016-01-01

    Onychomycosis is difficult to treat topically due to the deep location of the infection under the densely keratinized nail plate. In order to obtain an in vitro index that is relevant to the clinical efficacy of topical anti-onychomycosis drugs, we profiled five topical drugs: amorolfine, ciclopirox, efinaconazole, luliconazole, and terbinafine, for their nail permeabilities, keratin affinities, and anti-dermatophytic activities in the presence of keratin. Efinaconazole and ciclopirox permeat...

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

    Directory of Open Access Journals (Sweden)

    Harini P

    2010-09-01

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

  14. Efficacy of topical atorvastatin for the treatment of pressure ulcers: a randomized clinical trial.

    Science.gov (United States)

    Farsaei, Shadi; Khalili, Hossein; Farboud, Effat Sadat; Karimzadeh, Iman; Beigmohammadi, Mohammad Taghi

    2014-01-01

    To evaluate the effects of topical atorvastatin on the healing process of pressure ulcers in critically ill patients. Randomized, double-blind, placebo-controlled clinical trial. Medical-surgical intensive care unit of a university-affiliated teaching hospital in Tehran, Iran. One hundred four patients with stage I or II pressure ulcers, graded according to the 2-digit Stirling Pressure Sore Severity Scale. Patients were randomized to receive topical atorvastatin 1% ointment (51 patients [atorvastatin group]) or placebo ointment (53 patients [control group]) applied once/day to pressure ulcers for 14 days in addition to standard care for pressure ulcers. The efficacy of each treatment was assessed on days 7 and 14. Efficacy was determined based on the degree of healing of the existing pressure ulcer by using the 2-digit Stirling scale. The baseline stage of the pressure ulcers did not differ significantly between the control and atorvastatin groups. However, the mean ± SD stage of pressure ulcers significantly decreased in the atorvastatin group compared with the control group on day 7 (0.97 ± 0.76 vs 1.74 ± 0.75, pulcers in the atorvastatin group were significantly declined compared with the control group after 7 days (5.55 ± 4.55 vs 9.41 ± 5.03 cm², ppressure ulcers in critically ill patients. © 2013 Pharmacotherapy Publications, Inc.

  15. Examination of the clinical efficacy of eribulin and trastuzumab in HER2-positive recurrent breast cancer.

    Science.gov (United States)

    Kiba, Takayoshi; Morii, Nao; Takahashi, Hirotoshi; Ozaki, Shinji; Atsumi, Misao; Masumoto, Fumi; Shitakubo, Yoshimi; Yamashiro, Hiroyasu

    2016-01-01

    There are limited studies reported that describe the efficacy of eribulin and trastuzumab in the treatment of recurrent breast cancer. The present study examined the therapeutic efficacy of eribulin and trastuzumab in the treatment of recurrent breast cancer. Between October 2011 and August 2013, 5 recurrent breast cancer patients who were treated with eribulin and trastuzumab were included in the study. The cancer stages in the 5 women who received this regimen were stage IIIB in 1 (20%) and stage IV in 4 (80%). The sites of recurrence were the lung in 3 patients, liver in 2, bone in 1, brain in 1, supraclavicular lymph nodes in 1, infraclavicular lymph nodes in 1 and mediastinal lymph nodes in 1. The median number of prior treatment regimens was 5 (range, 5-11). Complete response was achieved in 0 patients, 1 achieved partial response, 3 had stable disease, and 1 had progressive disease. The overall response rate was 20%, and the clinical benefit rate was 80%. Patients also reported grade 3/4 neutropenia (80.0%). However, hematological toxicity was reversible and manageable. The most common grade 3/4 nonhematological toxicities were fatigue (20.0%), peripheral neuropathy (20.0%) and appetite loss (20.0%). No patients withdrew from treatment, and favorable compliance was achieved in the study. The results indicated that eribulin and trastuzumab have the potential to be one of the drugs for treatment of recurrent breast cancer.

  16. Clinical trials with allergen products: in search of biological markers of efficacy.

    Science.gov (United States)

    Moingeon, Philippe

    2006-01-01

    I discuss herein our efforts to identify biological markers of efficacy in support of the development of sublingual allergy vaccines. Biomarkers are of major interest to facilitate clinical development, for example by predicting safety and efficacy of candidate vaccines or their components (e.g. adjuvants and formulations) on the basis of immunogenicity evaluated in humans. They will be mandatory in the future to evaluate customized recombinant allergy vaccines designed upon component-resolved diagnosis. In this regard, they must ideally be both qualitative and quantitative. Such markers would also be useful to confirm foreseen mechanisms of action potentially associated with successful immunotherapy (e.g. the Treg hypothesis). The recent availability of sophisticated technologies (referred here as the technology push) to assess in details both humoral and cellular arms of the immune system provides new opportunities to identify such markers. In this regard, documenting natural immune responses, most particularly allergen-specific T cell responses in healthy persons, is critical to identify immunological correlates of protection, and thus to design optimal allergy vaccines.

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

    Science.gov (United States)

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

    2014-12-20

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

  18. Clinical efficacy of rizatriptan for patients with migraine: efficacy of drug therapy for migraine accompanied by tension headache-like symptoms, focusing on neck stiffness.

    Science.gov (United States)

    Okuma, Hirohisa; Kitagawa, Yasuhisa; Takagi, Shigeharu

    2005-12-01

    According to an epidemiological study in Japan, there are as many as 22 million patients with tension headache and 8.4 million with migraine. Furthermore, patients suffering from both types of headache concurrently are estimated to account for more than 50% of headache patients. We studied the efficacy of drug therapy for migraine accompanied by tension headache-like symptoms, focusing principally on neck stiffness. We evaluated the efficacy of rizatriptan by comparison of findings before and after therapy in 34 migraine patients, consisting of 16 without neck stiffness (migraine without neck factor: WONF) and 18 with it (migraine with neck factor: WNF), who received treatment at our neurology/internal medicine department from 1 March 2004 to 31 May 2005. In the study, all the patients were asked to keep a record of their migraine status. The severity of migraine was classified by physicians according to the International Headache Society diagnostic criteria, based on which drug efficacy was evaluated. We selected rizatriptan for migraine treatment in our study based on Dr. Ferrari's report. In the efficacy study of rizatriptan, in the group of 34 migraine patients, the pain relief rate (79.4%) and pain-free rate (41.2%) at two hours after treatment were as high as those reported in the meta-analysis performed by Ferrari et al., indicating high efficacy of rizatriptan. In the efficacy comparison between the WONF and WNF groups, the painfree rates were 56.3% and 27.8%, and cumulative pain relief rates were 100% and 61.1%, respectively, with better results in the WONF group. A test result was also significantly better (p=0.0076) in the WONF group. Rizatriptan was proved effective in treating migraine patients accompanied by tension headache-like symptoms. Comparison of efficacy rates between patient groups with and without tension headache-like symptoms showed that the pain relief rate in the group without neck stiffness was higher.

  19. Efficacy of ethanol-based hand foams using clinically relevant amounts: a cross-over controlled study among healthy volunteers

    Directory of Open Access Journals (Sweden)

    Marschall Sigunde

    2010-03-01

    Full Text Available Abstract Background Foams containing 62% ethanol are used for hand decontamination in many countries. A long drying time may reduce the compliance of healthcare workers in applying the recommended amount of foam. Therefore, we have investigated the correlation between the applied amount and drying time, and the bactericidal efficacy of ethanol foams. Methods In a first part of tests, four foams (Alcare plus, Avagard Foam, Bode test foam, Purell Instant Hand Sanitizer containing 62% ethanol, which is commonly used in U.S. hospitals, were applied to 14 volunteers in a total of seven variations, to measure drying times. In a second part of tests, the efficacy of the established amount of foam for a 30 s application time of two foams (Alcare plus, Purell Instant Hand Sanitizer and water was compared to the EN 1500 standard of 2 × 3 mL applications of 2-propanol 60% (v/v, on hands artificially contaminated with Escherichia coli. Each application used a cross-over design against the reference alcohol with 15 volunteers. Results The mean weight of the applied foam varied between 1.78 and 3.09 g, and the mean duration to dryness was between 37 s and 103 s. The correlation between the amount of foam applied and time until hands felt dry was highly significant (p 10-reduction: 3.05 ± 0.45 and Alcare plus (3.58 ± 0.71 was significantly less effective than the reference disinfection (4.83 ± 0.89 and 4.60 ± 0.59, respectively; p 10-reduction of 2.39 ± 0.57. Conclusions When using 62% ethanol foams, the time required for dryness often exceeds the recommended 30 s. Therefore, only a small volume is likely to be applied in clinical practice. Small amounts, however, failed to meet the efficacy requirements of EN 1500 and were only somewhat more effective than water.

  20. Analgesic efficacy of diazepam and placebo in patients with temporomandibular disorders: A double blind randomized clinical trial

    Directory of Open Access Journals (Sweden)

    G V Pramod

    2011-01-01

    Full Text Available Aim: The aim of the study was to evaluate and compare the analgesic efficacy of placebo and diazepam in patients with temporomandibular disorder. Materials and Methods: Thirty-five patients were recruited with a diagnosis of temporomandibular disorder based on standard clinical diagnostic criteria for temporomandibular disorder. The patients were put in to one of the two groups: placebo or diazepam at random. The average pain intensity was recorded with visual analog scale (VAS at pretreatment, at weekly interval till the completion of a three-week trial and at post-treatment visit on the eighth week from baseline. The secondary outcome measures were changes in masticatory muscle tenderness, viz. massater muscle, lateral pterygoid muscle, medial pterygoid muscle and temporalis muscle and changes in mouth opening. Statistical Analysis: Intra-group comparison for analgesic efficacy and mouth opening was carried out by Wilcoxon′s signed ranked test. Inter-group comparison for analgesic efficacy was also carried out using Mann-Whitney′s test. Results: A statistically significant (P<0.01 decrease in temporomandibular disorder pain in the placebo group (65% and statistically highly significant (P<0.001 decrease in the diazepam group (72% were observed on VAS after three weeks of treatment. The inter-group comparison demonstrated no statistically significant difference between the groups. Conclusion: This study suggests that the placebo can give near similar results as diazepam can. So the role of placebo should also be considered as one of the important management strategies. In the short term, reduction in the masticatory muscle tenderness and significant improvement in the mouth opening in both the groups were observed.

  1. Efficacy and safety of liposomal anthracyclines in phase I/II clinical trials.

    Science.gov (United States)

    Alberts, David S; Muggia, Franco M; Carmichael, James; Winer, Eric P; Jahanzeb, Mohammad; Venook, Alan P; Skubitz, Keith M; Rivera, Edgardo; Sparano, Joseph A; DiBella, Nicholas J; Stewart, Simon J; Kavanagh, John J; Gabizon, Alberto A

    2004-12-01

    Preclinical studies have established the pharmacologic advantages of liposomal anthracyclines, including pharmacokinetic profiles after bolus dosing that resemble continuous infusion of conventional anthracyclines, increased drug concentrations in tumor cells compared with the surrounding tissues, and reduced toxicity relative to conventional anthracycline treatment. Based on these studies, many phase I and phase II clinical trials were conducted to assess the safety and potential activity of liposomal anthracyclines in the management of both solid and hematologic tumors. These studies provided valuable insight into the safety of pegylated liposomal doxorubicin (Doxil/Caelyx [PLD]), nonpegylated liposomal doxorubicin (Myocet [NPLD]), and liposomal daunorubicin (DaunoXome [DNX]) over a range of doses, either as single-agent therapy or in combination with other cytotoxic agents. Other liposomal anthracyclines in development may be well tolerated but their activity remains to be elucidated by clinical trials. The available data also suggest that liposomal anthracyclines have activity not only against tumor types with known sensitivity to conventional anthracyclines, but also potentially for tumors that are typically anthracycline-resistant. Despite the availability of clinical data from a wide variety of tumor types and patient populations, further studies of liposomal anthracycline therapy are needed to fully establish their safety, efficacy, and dosing in the treatment of these patients.

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

    Science.gov (United States)

    Natesan, Suganthini Krishnan; Chandrasekar, Pranatharthi H

    2016-01-01

    The majority of invasive mold infections diagnosed in immunocompromised cancer patients include invasive aspergillosis (IA) and mucormycosis. Despite timely and effective therapy, mortality remains considerable. Antifungal agents currently available for the management of these serious infections include triazoles, polyenes, and echinocandins. Until recently, posaconazole has been the only triazole with a broad spectrum of anti-mold activity against both Aspergillus sp. and mucorales. Other clinically available triazoles voriconazole and itraconazole, with poor activity against mucorales, have significant drug interactions in addition to a side effect profile inherent for all triazoles. Polyenes including lipid formulations pose a problem with infusion-related side effects, electrolyte imbalance, and nephrotoxicity. Echinocandins are ineffective against mucorales and are approved as salvage therapy for refractory IA. Given that all available antifungal agents have limitations, there has been an unmet need for a broad-spectrum anti-mold agent with a favorable profile. Following phase III clinical trials that started in 2006, isavuconazole (ISZ) seems to fit this profile. It is the first novel triazole agent recently approved by the United States Food and Drug Administration (FDA) for the treatment of both IA and mucormycosis. This review provides a brief overview of the salient features of ISZ, its favorable profile with regard to spectrum of antifungal activity, pharmacokinetic and pharmacodynamic parameters, drug interactions and tolerability, clinical efficacy, and side effects. PMID:27994475

  3. Safety and efficacy of roxatidine acetate. Evidence from pharmacodynamic and clinical trials.

    Science.gov (United States)

    Merki, H S; Bender, W; Labs, R

    1989-01-01

    The effects of a new H2-receptor antagonist, roxatidine acetate, have been investigated in both clinical and pharmacodynamic trials in Europe and the United States. A series of four double-blind randomized studies are reviewed, reporting the effects of different dose regimens of roxatidine acetate compared with ranitidine and placebo in healthy volunteers using continuous intragastric pH monitoring. These pharmacodynamic studies clearly demonstrate that roxatidine acetate is an effective gastric antisecretory agent, which is up to twice as potent as ranitidine. The results of several clinical studies of roxatidine acetate in patients with gastric as well as duodenal ulcer conducted in Europe, Japan, and the United States are also reviewed. These studies show that roxatidine acetate is comparable to other potent H2-receptor antagonists in terms of cumulative healing rates, pain relief, and safety. Overall, the pharmacodynamic and clinical data indicate that the efficacy of roxatidine acetate 75 mg twice-daily (b.i.d.) does not differ significantly from ranitidine 150 mg b.i.d. Roxatidine acetate is equally effective in the treatment of peptic disease including gastric ulcer, duodenal ulcer, and reflux esophagitis.

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

    Directory of Open Access Journals (Sweden)

    J Carlos Flores-González

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

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

    Science.gov (United States)

    Flores-González, J Carlos; Matamala-Morillo, Miguel A; Rodríguez-Campoy, Patricia; Pérez-Guerrero, Juan J; Serrano-Moyano, Belén; Comino-Vazquez, Paloma; Palma-Zambrano, Encarnación; Bulo-Concellón, Rocio; Santos-Sánchez, Vanessa; Lechuga-Sancho, Alfonso M

    2015-01-01

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

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

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

    2007-06-15

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

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

    Energy Technology Data Exchange (ETDEWEB)

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

    1988-07-01

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

  8. CLINICAL EFFICACY OF CRUX SYRUP IN THE MANAGEMENT OF COUGH DUE TO VARIOUS ETIOLOGICAL CONDITIONS

    Directory of Open Access Journals (Sweden)

    Patel Girish

    2013-10-01

    Full Text Available Cough associated with acute and chronic respiratory conditions is common in patients of all ages. The objective of this study was to determine the clinical efficacy of CRUX syrup, a proprietary mixture of herbal ingredients in the management of cough of various etiological conditions in open label, uncontrolled, prospective cohort study. 55 Patients aged 9 - 64 years with cough of more than 1 day but less than 14 days duration was recruited. They were prescribed dose of CRUX syrup according to severity of cough for three days. Treatment results were assessed on the basis of Investigator’s evaluation. At the end of three days prescribed treatment, evaluator’s assessment shown that 29 % patient gave excellent, 55 % patient gave good, 11 % patient gave fair and 5 % patient gave poor response to treatment. The results demonstrate that CRUX treatment has significant decrease in the frequency and severity of cough without any significant side effect in patients of all ages.

  9. Efficacy and safety of midazolam for sedation in pediatric dentistry: a controlled clinical trial.

    Science.gov (United States)

    Azevedo, Isabelita Duarte; Ferreira, Maria Angela Fernandes; da Costa, Anna Paula Serejo; Bosco, Vera Lúcia; Moritz, Rachel Duarte

    2013-01-01

    Pharmacological management of uncooperative children is becoming increasingly common in the dental setting. The purpose of this study was to determine the efficacy and safety of 3 different doses of midazolam for sedation in 2- to 4- year-old children with multiple dental needs and negative behavior. Ten children participated in this crossover, controlled, double-blinded clinical trial, which evaluated their behavior, appointment length and patient response after administration of 3 different doses of midazolam or placebo. Oxygen saturation, heart rate, respiratory rate, and blood pressure were monitored in all sessions. Sedated children exhibited a more positive behavior compared to the placebo group, both at the beginning of the appointment (sitting in the chair) and during administration of local anesthesia (P=.008 and Ppediatric sedation in the dosages studied.

  10. Impact of CYP2D6 polymorphisms on clinical efficacy and tolerability of metoprolol tartrate.

    Science.gov (United States)

    Hamadeh, I S; Langaee, T Y; Dwivedi, R; Garcia, S; Burkley, B M; Skaar, T C; Chapman, A B; Gums, J G; Turner, S T; Gong, Y; Cooper-DeHoff, R M; Johnson, J A

    2014-08-01

    Metoprolol is a selective β-1 adrenergic receptor blocker that undergoes extensive metabolism by the polymorphic enzyme cytochrome P450 2D6 (CYP2D6). Our objective was to investigate the influence of CYP2D6 polymorphisms on the efficacy and tolerability of metoprolol tartrate. Two hundred and eighty-one participants with uncomplicated hypertension received 50 mg of metoprolol twice daily followed by response-guided titration to 100 mg twice daily. Phenotypes were assigned based on results of CYP2D6 genotyping and copy number variation assays. Clinical response to metoprolol and adverse effect rates were analyzed in relation to CYP2D6 phenotypes using appropriate statistical tests. Heart rate response differed significantly by CYP2D6 phenotype (P metoprolol response or tolerability.

  11. Clinical Efficacy of Oral Ganciclovir for Prophylaxis and Treatment of Recurrent Herpes Simplex Keratitis

    Directory of Open Access Journals (Sweden)

    Xin Wang

    2015-01-01

    Full Text Available Background: Herpes simplex keratitis (HSK caused by herpes simplex virus 1 (HSV-1, which has high recurrent rate and incidence of severe vision loss, is the leading cause of infectious blindness in the world. The aim was to explore the clinical efficacy of oral ganciclovir (GCV in the prevention of recurrent HSK. Methods: A multicenter, prospective, randomized, single-blind, and controlled clinical trial was conducted from April 2010 to June 2013. One hundred seventy-three patients (173 eyes involved who were diagnosed as recurrent HSK definitely, including stromal keratitis and corneal endotheliitis, were divided into three groups randomly: negative control (placebo group was topically administered with 0.15% GCV ophthalmic gel, 4 times per day and 0.1% fluorometholone eye drops, 3 times per day until resolution of HSK; positive control acyclovir (ACV group was topically adopted the same ophthalmic gel and eye drops and additionally received oral ACV 400 mg 5 times a day for 10 weeks and followed by 400 mg 2 times per day for 6 months; test GCV group was topically adopted the same treatment as negative control group and additionally received oral GCV 1000 mg 3 times per day for 8 weeks. The symptoms and signs were evaluated before and after the therapy 1 st week, 2 nd week and then followed up every 2 weeks until recovery. Furthermore, we followed up recurrence of HSK for every 3 months after recovery and then assessed the cure time, recurrent rate and adverse reactions. Results: One hundred and seventy-three patients were followed up 7-48 months (mean 32.1 ± 12.3 months, but 34 patients were failed to follow-up. The cure time was 12.1 ± 4.3, 11.9 ± 4.0 weeks in negative control (placebo group and positive control ACV group respectively (P = 0.991, which was longer than that in test GCV group (8.6 ± 2.8 weeks and there was a significant difference between test GCV group and negative control (placebo group or positive control ACV group (P

  12. College and Academic Self-Efficacy as Antecedents for High School Dual-Credit Enrollment

    Science.gov (United States)

    Ozmun, Cliff D.

    2013-01-01

    Do high school students who are predisposed to enroll in dual-credit courses already possess high levels of motivation or college and academic self-efficacy? Students in this study reported being academically motivated, but they did not report high levels of confidence in their ability to perform certain college-associated tasks. Of 52 items…

  13. Efficacy of a clinical decision-support system in an HIV practice: a randomized trial.

    Science.gov (United States)

    Robbins, Gregory K; Lester, William; Johnson, Kristin L; Chang, Yuchiao; Estey, Gregory; Surrao, Dominic; Zachary, Kimon; Lammert, Sara M; Chueh, Henry C; Meigs, James B; Freedberg, Kenneth A

    2012-12-04

    Data to support improved patient outcomes from clinical decision-support systems (CDSSs) are lacking in HIV care. To test the efficacy of a CDSS in improving HIV outcomes in an outpatient clinic. Randomized, controlled trial. (ClinicalTrials.gov registration number: NCT00678600) Massachusetts General Hospital HIV Clinic. HIV care providers and their patients. Computer alerts were generated for virologic failure (HIV RNA level >400 copies/mL after a previous HIV RNA level ≤400 copies/mL), evidence of suboptimal follow-up, and 11 abnormal laboratory test results. Providers received interactive computer alerts, facilitating appointment rescheduling and repeated laboratory testing, for half of their patients and static alerts for the other half. The primary end point was change in CD4 cell count. Other end points included time to clinical event, 6-month suboptimal follow-up, and severe laboratory toxicity. Thirty-three HIV care providers followed 1011 patients with HIV. In the intervention group, the mean increase in CD4 cell count was greater (0.0053 vs. 0.0032 × 109 cells/L per month; difference, 0.0021 × 109 cells/L per month [95% CI, 0.0001 to 0.004]; P = 0.040) and the rate of 6-month suboptimal follow-up was lower (20.6 vs. 30.1 events per 100 patient-years; P = 0.022) than those in the control group. Median time to next scheduled appointment was shorter in the intervention group than in the control group after a suboptimal follow-up alert (1.71 vs. 3.48 months; P 6 months; P = 0.072). More than 90% of providers supported adopting the CDSS as part of standard care. This was a 1-year informatics study conducted at a single hospital subspecialty clinic. A CDSS using interactive provider alerts improved CD4 cell counts and clinic follow-up for patients with HIV. Wider implementation of such systems can provide important clinical benefits. National Institute of Allergy and Infectious Diseases.

  14. Safety and clinical efficacy of granulocyte and monocyte adsorptive apheresis therapy for ulcerative colitis

    Institute of Scientific and Technical Information of China (English)

    Takayuki Yamamoto; Satoru Umegae; Koichi Matsumoto

    2006-01-01

    Active ulcerative colitis (UC) is frequently associated with infiltration of a large number of leukocytes into the bowel mucosa. Therefore, removal of activated circulating leukocytes by apheresis has the potential for improving UC. In Japan, since April 2000, leukocytapheresis using Adacolumn has been approved as the treatment for active UC by the Ministry of Health and Welfare. The Adacolumn is an extracorporeal leukocyte apheresis device filled with cellulose acetate beads, and selectively adsorbs granulocytes and monocytes/macrophages. To assess the safety and clinical efficacy of granulocyte and monocyte adsorptive apheresis (GMCAP) for UC, we reviewed 10 open trials of the use of GMCAP to treat UC. One apheresis session (session time, 60 min) per week for five consecutive weeks (a total of five apheresis sessions) has been a standard protocol. Several studies used modified protocols with two sessions per week, with 90-min session, or with a total of 10 apheresis sessions.Typical adverse reactions were dizziness, nausea,headache, flushing, and fever. No serious adverse effects were reported during and after GMCAP therapy, and almost all the patients could complete the treatment course. GMCAP is safe and well-tolerated. In the majority of patients, GMCAP therapy achieved clinical remission or improvement. GMCAP is a useful alternative therapy for patients with steroid-refractory or -dependent UC.GMCAP should have the potential to allow tapering the dose of steroids, and is useful for shortening the time to remission and avoiding re-administration of steroids at the time of relapse. Furthermore, GMCAP may have efficacy as the first-line therapy for steroid-naive patients or patients who have the first attack of UC. However,most of the previous studies were uncontrolled trials. To assess a definite efficacy of GMCAP, randomized, doubleblind, sham-controlled trials are necessary. A seriousproblem with GMCAP is cost; a single session costs (¥)145 000 ($1 300

  15. Clinical Observationon on the Short-term Clinical Efficacy and Safety of Temozolomide Combined with Radiotherapy for High Grade Gliomas%替莫唑胺联合调强放疗治疗高级别胶质瘤的近期疗效和不良反应的临床观察

    Institute of Scientific and Technical Information of China (English)

    黄蕾; 陈诚; 吴俚蓉; 吴建峰

    2013-01-01

    Objective To investigate the short-term clinical efifcacy and safety of postoperative radiotherapy combined with temozolomide chemotherapy in treating high-grade gliomas. Methods Forty-eight patients with high-grade gliomas who had accepted resection were divided into two groups:control group(n=24)and combination treatment group(n=24). Both groups were given intensity modulated radiotherapy with total dose of 60 Gy and the control group was given additional Temozolomide chemotherapy.The complete blood count,hepatic and renal function of all patients in both group were monitored. Results The total effective rate in the combination treatment group was 79.17%(19/24),which was 41.67%(10/24)in the control group.The total effective rates were significantly different between the two groups(P<0.05).There were more adverse reactions in the combination treatment group than in the control group. Adverse effects could be relieved after symptomatic treatment. Conclusion Intensity modulated radiotherapy combined with Temozolomide chemotherapy for high-grade gliomas can improve curative effects,is safe and reliable.%目的:观察替莫唑胺联合调强放疗治疗高级别胶质瘤的近期临床疗效,评估治疗的安全性。方法对48例高级别脑胶质瘤术后患者进行回顾性研究,分为对照组(n=25)、联合治疗组(n=24)。对照组患者术后行调强放疗,总剂量60Gy;联合治疗组患者行调强放疗的同时口服替莫唑胺75mg/(m2•d)。两组患者治疗过程中每周监测血常规、肝功能及肾功能。结果49例高级别脑胶质瘤术后患者放化疗结束后随访12个月,联合治疗组的总有效率为79.17%(19/24),对照组的总有效率为41.67%(10/24),两组比较,差异有统计学意义(P<0.05)。联合治疗组患者不良反应较对照组多见,但经对症治疗,可获得缓解,患者能耐受。结论替莫唑胺联合调强放疗治疗术后高级别胶质瘤脑胶

  16. Influencing risk behavior of sexually transmitted infection clinic visitors: efficacy of a new methodology of motivational preventive counseling.

    Science.gov (United States)

    Kuyper, Lisette; de Wit, John; Heijman, Titia; Fennema, Han; van Bergen, Jan; Vanwesenbeeck, Ine

    2009-06-01

    A quasi-experimental study was conducted at a Dutch sexually transmitted infection (STI) clinic to compare the effects of educational counseling and motivational interviewing (MI)-based HIV/STI counseling on determinants of condom use and partner notification at 6-month follow-up. It also examined the feasibility of MI-based counseling in a busy real-life clinic. The counseling approaches were historically compared: respondents in the control condition were recruited between April and July 2005, those in the experimental condition between September and December 2005. The study involved 428 participants. These were all high-risk clients of the STI clinic. Their mean age was 33.7 years, and 39.6% were female. The study showed that MI-based counseling had a more positive effect on self-efficacy, intentions to use condoms with casual partners, and long-term condom use with steady partners. It had no adversarial outcomes on other social cognitions or behaviors compared to educational counseling. Furthermore, MI-based counseling is experienced as a more respectful and structured way of counseling. MI-based counseling was relatively easily implemented into the current clinic procedures. In addition to the implementation of the training, neither specialized staff nor additional or longer client visits were needed. However, some nurses indicated that the new method required more personal investment and effort. Limitations of the current study are the low response rates, the high educational level of most participants, and the small sample size regarding partner notification. Nonetheless, we conclude that MI-based counseling was a more effective approach to preventive counseling compared to educational counseling and feasible in the busy real-life setting.

  17. Evaluation of the Efficacy of Highly Hydrophilic Polyurethane Foam Dressing in Treating a Diabetic Foot Ulcer.

    Science.gov (United States)

    Jung, Jae-A; Yoo, Ki-Hyun; Han, Seung-Kyu; Dhong, Eun-Sang; Kim, Woo-Kyung

    2016-12-01

    To demonstrate the efficacy of a highly hydrophilic polyurethane foam dressing in the treatment of diabetic ulcers. Diabetic foot ulcers often pose a difficult treatment problem. Polyurethane foam dressings have been used worldwide to accelerate wound healing, but only a few clinical studies demonstrate the effect of foam dressing on the healing of diabetic ulcers. Medical records of 1342 patients with diabetic ulcers who were admitted and treated at the authors' institution were reviewed. A total of 208 patients met the study's inclusion criteria. Of these 208 patients, 137 were treated with a highly hydrophilic polyurethane foam dressing, and 71 were treated with saline gauze (control group). Except for the application of polyurethane foam dressing, the treatment method was identical for patients in both groups. The wound healing outcomes of the 2 groups were compared. Complete wound healing occurred in 87 patients (63.5%) in the polyurethane foam dressing group and in 28 patients (39.4%) in the control group within 12 weeks (P polyurethane foam dressing and control groups, respectively (P polyurethane foam dressing may provide an effective treatment strategy for diabetic foot ulcers.

  18. Therapeutic efficacy of artemether-lumefantrine against uncomplicated Plasmodium falciparum malaria in a high-transmission area in northwest Ethiopia.

    Science.gov (United States)

    Teklemariam, Michael; Assefa, Ashenafi; Kassa, Moges; Mohammed, Hussien; Mamo, Hassen

    2017-01-01

    Malaria, particularly due to Plasmodium falciparum, remains a major public health threat in Ethiopia. Artemether-lumefantine (AL) has been the first-line antimalarial drug against uncomplicated P. falciparum malaria in the country since 2004. Regular monitoring of antimalarial drugs is recommended by the World Health Organization (WHO) to help early detection of drug resistant strains of the parasite and contain their rapid spread. The objective of this study was to assess the therapeutic efficacy of AL in a high-transmission setting in Ethiopia. The study site was Setit Humera, northwest Ethiopia. Single-arm prospective study of a 28-day follow-up was conducted from October 2014 to January 2015 according to the revised WHO 2009 drug efficacy study protocol. Study end-points were classified into primary end-point and secondary end-point. While the primary end-point was the day-28 adequate clinical and parasitological response the secondary end-points were clinical and parasitological evaluations (parasite, fever and gametocyte clearance rate, incidence of drug adverse events) and the relative increment in hemoglobin (Hb) level from baseline to day (D) 14 and D28. A total of 92 patients were enrolled and 79 had completed the 28-day follow-up period. The overall cure rate was 98.8% with 95% confidence interval of 0.915-0.998 without polymerase chain reaction correction. The parasite clearance rate was high with fast resolution of clinical symptoms; 100% of the study participants cleared parasitaemia and fever on D3. Gametocyte carriage was reduced from 7% on D0 to 1% on D3 and complete clearance was achieved on D14. Mean Hb concentration significantly increased on D28 compared to that on D14. There was no serious adverse event. AL was efficacious and safe in a high-transmission setting for treatment of uncomplicated falciparum malaria.

  19. A synthetic estimator for the efficacy of clinical trials with all-or-nothing compliance.

    Science.gov (United States)

    Antonelli, Joseph; Han, Bing; Cefalu, Matthew

    2017-08-18

    A critical issue in the analysis of clinical trials is patients' noncompliance to assigned treatments. In the context of a binary treatment with all or nothing compliance, the intent-to-treat analysis is a straightforward approach to estimating the effectiveness of the trial. In contrast, there exist 3 commonly used estimators with varying statistical properties for the efficacy of the trial, formally known as the complier-average causal effect. The instrumental variable estimator may be unbiased but can be extremely variable in many settings. The as treated and per protocol estimators are usually more efficient than the instrumental variable estimator, but they may suffer from selection bias. We propose a synthetic approach that incorporates all 3 estimators in a data-driven manner. The synthetic estimator is a linear convex combination of the instrumental variable, per protocol, and as treated estimators, resembling the popular model-averaging approach in the statistical literature. However, our synthetic approach is nonparametric; thus, it is applicable to a variety of outcome types without specific distributional assumptions. We also discuss the construction of the synthetic estimator using an analytic form derived from a simple normal mixture distribution. We apply the synthetic approach to a clinical trial for post-traumatic stress disorder. Copyright © 2017 John Wiley & Sons, Ltd.

  20. Clinical efficacy of intravitreal Ranibizumab in idiopathic choroid neovascularization type Ⅰand type Ⅱ

    Directory of Open Access Journals (Sweden)

    Yue-Ming Sun

    2015-07-01

    Full Text Available AIM: To evaluate the efficacy of intravitreal ranibizumab in idiopathic choroid neovascularization(ICNV, compare the difference of the curative effect between type Ⅰand Ⅱof ICNV by optical coherence tomography(OCT, further provide evidence of the to effectiveness of ranibizumab in the treatment of choroidal neovascularization to guide clinical treatment. METHODS: A retrospective analysis on the clinical data who were diagnosed as ICNV between October 2013 and June 2014 in our hospital were carried out. Totally 31 cases(9 cases of type Ⅰ and 22 cases of type Ⅱaccepted ranibizumab injection voluntarily.All of the patients were evaluated by ophthalmic examination, funduscopy and OCT before and after the injection, classificated according to OCT results. The best-corrected visual acuity(BCVAand maximum of edema thickness after ranibizumab treatment at 3mo follow-up were compared. RESULTS: After statistically analyzed, BCVA and maximum thickness of the retinal lesions of 31 patients(type Ⅰ9 cases, type Ⅱ 22 casesbefore and 1, 3mo after treatment had statistical significance. In different types of retinal ICNV patients, BCVA and maximum thickness of the retinal lesions before and after treatment had no statistical significance. It was said that ranibizumab intravitreal injection had effectiveness for ICNV, however, there were no significant effectiveness for typeⅠ andⅡ ICNV. CONCLUSION: Ranibizumab intravitreal injection has obvious effectiveness for ICNV. However, it has no effect on typeⅠ andⅡ ICNV. Its safety and long-term complications need for further study.

  1. Different angiotensin-converting enzyme inhibitors have similar clinical efficacy after myocardial infarction

    DEFF Research Database (Denmark)

    Hansen, Morten L; Gislason, Gunnar H; Køber, Lars

    2008-01-01

    regression analysis demonstrated no differences in risk for all-cause mortality, but patients using captopril had higher risk of reinfarction (hazard ratio 1.18, 95% confidence interval 1.05, 1.34). However, following adjustment for differences in used dosages, all ACE inhibitors had similar clinical...... efficacy. Risk of all-cause mortality: trandolapril (reference) 1.00, ramipril 0.97 (0.89, 1.05), enalapril 1.04 (0.95, 1.150), captopril 0.95 (0.83, 1.08), perindopril 0.98 (0.84, 1.15) and other ACE inhibitors or angiotensin II receptor blockers (ARB) 1.06 (0.94, 1.19). Reinfarction: trandolapril...... (reference) 1.00, ramipril 0.98 (0.89, 1.08), enalapril 1.04 (0.92, 1.17), captopril 1.05 (0.89, 1.25), perindopril 0.96 (0.81, 1.14) and other ACE inhibitors or ARB 0.99 (0.86, 1.14). Furthermore, the association between ARBs and clinical events was similar to ACE inhibitors (trandolapril reference): all...

  2. Comparing Clinical Efficacy of Hyg and Ionic Toothbrushes in Removing Plaque from the Teeth

    Directory of Open Access Journals (Sweden)

    S Alaiee

    2013-08-01

    Full Text Available Introduction: Mechanical plaque control is the main way to prevent caries and periodontal diseases. Among the mechanical methods, daily use of toothbrush is considered as the best way to achieve oral health. Therefore, the purpose of this study was to evaluate clinical and microbiological efficacy of Hygenic toothbrushes in plaque removal. Methods: In this randomized clinical trial, 40 volunteers were selected. Patients were randomly divided into two groups, one group received toothbrushes with battery and the other group received toothbrushes without the battery. At the beginning of the study plaque score was measured and recorded. Patients brushed for a week and plaque was measured again. Then in both groups the first toothbrush was taken and the second brush was received by the volunteers in a cross over manner. In this regard, the mirobiological samples (colony forming units were determined before and after brushing. Data was analyzed by means of T- tests using the spss software. Results: The results showed that toothbrushes with and without battery reduced plaque score (respectively 98/22% and 26/19%. Colony forming units was reduced for both toothbrushes with battery (6/24% and without battery (9/5%. This indicates that toothbrushes with battery significantly reduced plaque compared to the ordinary toothbrushes. Conclusion: Hygenic toothbrushes reduce plaque score and microbial counts more effectively than ordinary toothbrushes.

  3. Percutaneous left atrial appendage closure devices: safety, efficacy, and clinical utility

    Directory of Open Access Journals (Sweden)

    Swaans MJ

    2016-09-01

    Full Text Available Martin J Swaans, Lisette IS Wintgens, Arash Alipour,  Benno JWM Rensing, Lucas VA Boersma Department of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands Abstract: Atrial fibrillation (AF is the most common arrhythmia treated in the clinical practice. One of the major complications of AF is a thromboembolic cerebral ischemic event. Up to 20% of all strokes are caused by AF. Thromboembolic cerebral ischemic event in patients with AF occurs due to atrial thrombi, mainly from the left atrial appendage (LAA. Prevention of clot formation with antiplatelet agents and especially oral anticoagulants (­vitamin K antagonists or newer oral anticoagulants has been shown to be effective in reducing the stroke risk in patients with AF but has several drawbacks with (major bleedings as the most important disadvantage. Therefore, physical elimination of the LAA, which excludes the site of clot formation by surgical or percutaneous techniques, might be a good alternative. In this review, we discuss the safety, efficacy, and clinical utility of the Watchman™ LAA closure device. Keywords: stroke, left atrial appendage, prevention, atrial fibrillation

  4. Clinical efficacy of blue light full body irradiation as treatment option for severe atopic dermatitis.

    Directory of Open Access Journals (Sweden)

    Detlef Becker

    Full Text Available BACKGROUND: Therapy of atopic dermatitis (AD relies on immunosuppression and/or UV irradiation. Here, we assessed clinical efficacy and histopathological alterations induced by blue light-treatment of AD within an observational, non-interventional study. METHODOLOGY/PRINCIPAL FINDINGS: 36 patients with severe, chronic AD resisting long term disease control with local corticosteroids were included. Treatment consisted of one cycle of 5 consecutive blue light-irradiations (28.9 J/cm(2. Patients were instructed to ask for treatment upon disease exacerbation despite interval therapy with topical corticosteroids. The majority of patients noted first improvements after 2-3 cycles. The EASI score was improved by 41% and 54% after 3 and 6 months, respectively (p≤0.005, and p≤0.002. Significant improvement of pruritus, sleep and life quality was noted especially after 6 months. Also, frequency and intensity of disease exacerbations and the usage of topical corticosteroids was reduced. Finally, immunohistochemistry of skin biopsies obtained at baseline and after 5 and 15 days revealed that, unlike UV light, blue light-treatment did not induce Langerhans cell or T cell depletion from skin. CONCLUSIONS/SIGNIFICANCE: Blue light-irradiation may represent a suitable treatment option for AD providing long term control of disease. Future studies with larger patient cohorts within a randomized, placebo-controlled clinical trial are required to confirm this observation.

  5. Bryophyllum pinnatum and Related Species Used in Anthroposophic Medicine: Constituents, Pharmacological Activities, and Clinical Efficacy.

    Science.gov (United States)

    Fürer, Karin; Simões-Wüst, Ana Paula; von Mandach, Ursula; Hamburger, Matthias; Potterat, Olivier

    2016-07-01

    Bryophyllum pinnatum (syn. Kalanchoe pinnata) is a succulent perennial plant native to Madagascar that was introduced in anthroposophic medicine in the early 20th century. In recent years, we conducted a large collaborative project to provide reliable data on the chemical composition, pharmacological properties, and clinical efficacy of Bryophyllum. Here, we comprehensively review the phytochemistry, as well as the pharmacological and clinical data. As to the pharmacology, special emphasis is given to properties related to the use in anthroposophic medicine as a treatment for "hyperactivity diseases", such as preterm labor, restlessness, and sleep disorders. Studies suggesting that B. pinnatum may become a new treatment option for overactive bladder syndrome are also reviewed. Tolerability is addressed, and toxicological data are discussed in conjunction with the presence of potentially toxic bufadienolides in Bryophyllum species. The few data available on two related species with medicinal uses, Bryophyllum daigremontianum and Bryophyllum delagoense, have also been included. Taken together, current data support the use of B. pinnatum for the mentioned indications, but further studies are needed to fully understand the modes of action, and to identify the pharmacologically active constituents.

  6. Clinical trials documenting the efficacy of low-dose glucocorticoids in rheumatoid arthritis.

    Science.gov (United States)

    Pincus, Theodore; Cutolo, Maurizio

    2015-01-01

    Twelve clinical trials have documented that prednisone or prednisolone in doses of 10 mg/day or less is efficacious to improve function, maintain status and/or slow radiographic progression in patients with rheumatoid arthritis (RA). An early trial reported by de Andrade et al. [Ann Rheum Dis 1964;23:158-162] in 1964 indicated that 5 mg of prednisolone at night was preferred to 5 mg of prednisone in the morning. Harris et al. [J Rheumatol 1983;10:713-721] documented the efficacy of 5 mg/day of prednisone in a non-double-blind trial in 1983. Two important trials in the 1990s by Kirwan [N Engl J Med 1995;333:142-146] using 7.5 mg/day, and the COBRA study by Boers et al. [Lancet 1997;350:309-318] with step-down from 60 mg rapidly tapered to 5 mg/day led to strong advocacy of low-dose glucocorticoids. In 2002, the first Utrecht Study [Ann Intern Med 2002;136:1-12] indicated that 10 mg/day prednisone slowed radiographic progression, a finding confirmed and extended in 2005 by Svensson et al. [Arthritis Rheum 2005;52:3360-3370] with 7.5 mg/day, and Wassenberg et al. [Arthritis Rheum 2005;52:3371-3380] with 5 mg/day of prednisolone. In 2008, Buttgereit et al. [Lancet 2008;371:205-214] reported CAPRA-1, which documented that modified-release prednisone or prednisolone taken at bedtime led to lower morning stiffness and IL-6 levels compared to usual morning prednisone. In 2009, Pincus et al. [Ann Rheum Dis 2009;68:1715-1720] reported a withdrawal clinical trial, in which patients who took 3 mg/day were gradually withdrawn to placebo, and dropped out at a significantly higher rate than control patients who were 'withdrawn' to prednisone. In 2012, a second Utrecht Study [Ann Intern Med 2012;156:329-339], CAMERA-II, documented that 10 mg of prednisone added to a 'treat-to-target' strategy with methotrexate provided incremental slowing of radiographic progression. An Italian study of patients with early RA who received step-up disease-modifying antirheumatic drug therapy over 2

  7. PRE-MARKET CLINICAL EVALUATIONS OF INNOVATIVE HIGH-RISK MEDICAL DEVICES IN EUROPE

    DEFF Research Database (Denmark)

    Hulstaert, F.; Neyt, M.; Vinck, I.

    2012-01-01

    Objectives: High-quality clinical evidence is most often lacking when novel high-risk devices enter the European market. At the same time, a randomized controlled trial (RCT) is often initiated as a requirement for obtaining market access in the US. Should coverage in Europe be postponed until RCT...... Bodies, Ethics Committees, and HTA agencies were consulted. We also discuss patient safety and the transparency of information. Results: In contrast to the US, there is no requirement in Europe to demonstrate the clinical efficacy of high-risk devices in the premarket phase. Patients in Europe can thus...

  8. Omega-3 fatty acids and inflammation: a perspective on the challenges of evaluating efficacy in clinical research.

    Science.gov (United States)

    Skulas-Ray, Ann C

    2015-01-01

    Chronic inflammation is a common underpinning of many diseases. There is a strong pre-clinical evidence base demonstrating the efficacy of omega-3 fatty acids for ameliorating inflammation and thereby reducing disease burden. Clinically, C-reactive protein (CRP) serves as both a reliable marker for monitoring inflammation and a modifiable endpoint for studies of anti-inflammatory pharmaceuticals. However, clinical omega-3 fatty acid supplementation trials have not replicated pre-clinical findings in terms of consistent CRP reductions. Methodological differences present numerous challenges in translating pre-clinical evidence to clinical results. It is crucial that future clinical nutrition research clearly distinguish between the reversal of established inflammation and preventing the development of inflammation. Future clinical studies evaluating the ability of omega-3 fatty acids to attenuate an excessive inflammatory response, may be advanced by employing new statistical approaches and utilizing models of induced inflammation, such as low-dose human endotoxemia.

  9. High reinforcing efficacy of nicotine in non-human primates.

    Directory of Open Access Journals (Sweden)

    Bernard Le Foll

    Full Text Available Although tobacco appears highly addictive in humans, there has been persistent controversy about the ability of its psychoactive ingredient nicotine to induce self-administration behavior in laboratory animals, bringing into question nicotine's role in reinforcing tobacco smoking. Because of ethical difficulties in inducing nicotine dependence in naïve human subjects, we explored reinforcing effects of nicotine in experimentally-naive non-human primates given access to nicotine for periods of time up to two years. Five squirrel monkeys with no experimental history were allowed to intravenously self-administer nicotine by pressing one of two levers. The number of presses on the active lever needed to obtain each injection was fixed (fixed-ratio schedule or increased progressively with successive injections during the session (progressive-ratio schedule, allowing evaluation of both reinforcing and motivational effects of nicotine under conditions of increasing response cost. Over time, a progressive shift toward high rates of responding on the active lever, but not the inactive lever, developed. The monkeys' behavior was clearly directed toward nicotine self-administration, rather than presentation of environmental stimuli associated with nicotine injection. Both schedules of reinforcement revealed a high motivation to self-administer nicotine, with monkeys continuing to press the lever when up to 600 lever-presses were needed for each injection of nicotine. Thus, nicotine, by itself, in the absence of behavioral or drug-exposure history, is a robust and highly effective reinforcer of drug-taking behavior in a non-human primate model predictive of human behavior. This supports the use of nicotinic ligands for the treatment of smokers, and this novel preclinical model offers opportunities to test future medications for the treatment of nicotine dependence.

  10. INFLUENCE OF STUDENT ENGLISH UTILITY AND TEACHER EFFICACY ON ENGLISH PROFICIENCY OF HIGH SCHOOL STUDENTS

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    Ruth A. ORTEGA-DELA CRUZ

    2016-12-01

    Full Text Available Learning second language considers a number of factors that influence the manner in which the language is taught. Understanding of the learners’ goals and motivation for learning is one. Using descriptive-correlational research design, this study determined the influence of student English utility and teacher efficacy on the students’ English proficiency. A total of 101 students from first year to fourth year level served as the respondents of the study. The study quantified the students’ perception towards English utility and their evaluation of English teacher efficacy which employed a researcher-made survey questionnaire. Results revealed high positive perceptions of students towards English utility. Analysis of variance revealed significant differences in the perceptions of high school students on the efficacy of their English teachers. Correlation coefficients indicated a positive linear relationship among the given variables. The p-value revealed significant relationship of teacher efficacy (r = .691, p-value = .000 and English utility (r = .467, p-value = .000 to students’ English proficiency. Results of regression statistics revealed that English utility has no significant influence on the student English proficiency. Therefore, the main factor that must still be considered then should be the teacher. Finally, there is an explicit indication that high level of teachers’ efficacy performing in teaching has much powerful influence on the English proficiency of high school students. Thus improving the methods of teaching English provides a better way of motivating students to achieve higher levels of proficiency in the future.

  11. Efficacy of Cinnarizine and Sodium Valproate in migraine prophylaxis: a clinical trial

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    M. Togha

    2006-07-01

    Full Text Available Background: Calcium-antagonists (CA are heterogeneous group of drugs with different efficacy in migraine prophylaxis. Several studies have firmly demonstrated flunarizine (FLU, and verapamil as the proven calcium-antagonists for migraine prophylaxis. Cinnarizine (CIN, is another CA with less complications and less antihistaminic action. There is very few studies to show the effect of this drug on migraine. The current study evaluates the efficacy and safety of cinnarizine on migraine in comparison to sodium valproate, an acceptable drug in migraine prophylaxis. Methods: The current study is a randomized double blind clinical trial on 133 participants with intractable migraine headache to evaluate the positive effect of cinnarizine in comparison to sodium valproate. The data was collected and analized by SPSS software. Results: The mean age of cases was 34.3±10 years in Cinnarizine group and 33.4±11 in Sodium Valproate users. The headache frequency decreased to about 50% and its severity to about 30% in both groups. Although the effect of Cinnarizine was started earlier than sodium valproate , there was no significant difference between two groups of cases in improvement of headache attacks. Statistically significant difference was noted in drug’s complication led to discontinuation of treatment, 5.2% in Cinnarizine users in respect to 14% in valproate group. Conclusion: The patients who received Cinnarizine, similar to the patients on sodium valprote showed significant improvement in headache attacks, frequency, duration and severity. Cinnarizine such as sodium valproate is an effective drug in migraine prophylaxis even in intractable headache, but with lesser severe complication.

  12. The efficacy of high-dose penicillin for community-acquired pneumonia diagnosed by pneumococcal urine antigen test.

    Science.gov (United States)

    Oka, Hideaki; Ueda, Atsuhisa; Watanuki, Yuji; Tsukiji, Jun; Kuroda, Hideyo; Akashi, Syunsuke; Hirai, Yoshihiro; Fuyuki, Toshiharu; Kaneko, Takeshi; Ishigatsubo, Yoshiaki

    2009-04-01

    We analyzed the efficacy of both the Streptococcus pneumoniae urine antigen test as a quick diagnostic tool and the administration of high-dose penicillin in response to a positive S. pneumoniae urine antigen test. We conducted a retrospective analysis of 48 cases of pneumococcal pneumonia, in which the patients were treated with high-dose penicillin. All the cases were diagnosed by a positive urine antigen test. Treatment with high-dose penicillin was effective in 43 of the 48 patients. This treatment was also effective in 12 of 16 culture-confirmed cases with low susceptibility to penicillin. Eleven patients who were positive for the S. pneumoniae urine antigen test but culture-negative showed clinical improvement with high-dose penicillin. Pneumonia caused by S. pneumoniae appeared to be treated safely and effectively with high-dose penicillin based on positive results of the urine antigen test, as penicillin resistance was unlikely to be a problem.

  13. Efficacy of beta-carotene topical application in melasma: An open clinical trial

    Directory of Open Access Journals (Sweden)

    Kar H

    2002-11-01

    Full Text Available b-carotene, a structural analogue of vitamin A, works as an agonist of this vitamin, by reversibly sticking the chemical mechanism of melanogenesis by saturating the nuclear receptors of melanocytes and/or binding protein. To study the safety and efficacy of b-carotene lotion on topical application in melasma, clinically diagnosed 31 adults (26F and 5M with melasma were included in this trial. All of them applied b-carotene lotion daily, morning and evening to the affected areas. Twenty six of them completed regular 8 weeks treatment. Nine of them continued same treatment for 16 more weeks. All cases were evaluated clinically using melasma intensity (MPi index (Grade I, II, III and size of the lesion. Clinical photograph was taken for each case at 0 week, 8′h week and 24th week. Initial 8 weeks treatment revealed that the single case with grade-I pigmentation included in this study recovered completely. Two out of 13 cases with grade-II pigmentation, showed no change, in 10 cases, pigmentation became lighter to grade-I (76. 9% and one case recovered completely. Out of 12 grade-III cases, one did not show any change, 10(83. 3% converted to grade-II and one to grade-I. At the end of 24 weeks, all the nine cases (2 grade-II and 7 grade III showed further clearing of the pigmentation to the next lower grade. Side-effects like mild erythema and local irritation were observed in two cases each, who were advised to discontinue treatment as per the protocol. In conclusion, topical application of b-carotene lotion appears to bean effective and safe for melosma. Longer duration of application is associated with better result.

  14. Clinical efficacy of levonorgestrel and norethisterone for the treatment of chronic abnormal uterine bleeding.

    Science.gov (United States)

    Ashraf, Muhammad Nadeem; Habib-Ur-Rehman, Agha; Shehzad, Zahid; AlSharari, Shakir DakheelAllah; Murtaza, Ghulam

    2017-09-01

    To compare the clinical efficacy of levonorgestrel intrauterine system with oral norethisterone for the treatment of idiopathic chronic abnormal uterine bleeding. This cross-sectional study was conducted at Bahawal Victoria Hospital, Jubilee Female Hospital, Civil Hospital and private clinics of consultant gynaecologists in Bahawalpur, Pakistan, from March to August 2014, and comprised patients presenting with abnormal uterine bleeding. The patients were equally and randomly divided into two groups, i.e. intrauterine levonorgestrel administered (group A) and norethisterone administered (group B). Mean age, duration of the disease and parity were determined using a predesigned questionnaire. The primary outcomes of the treatments, i.e. reduction in menstrual blood loss assessed by the pictorial blood assessment chart score, were recorded before the initiation of therapy, at 3 months and at 6months of the study. SPSS 16 was used for data analysis. There were 76 subjects; 38(50%) in each group. In group A, the mean age and mean duration of the disease was 34.16±6.327 years and 6.18±2.415 years compared to 34.21±3.595 years and 6.21±2.418 years in group B. The reduction in menstrual blood loss did not differ significantly between the groups after 3 months (p= 0.321). However, levonorgestrel intrauterine system was found more effective in reducing menstrual blood loss in 36(94.73%) patients, compared to norethisterone-treated patients 28(73.68%) after 6 months of the treatment (p=0.041). The response of both the treatments was found independent of patient's age, parity and chronicity of the disease. The levonorgestrel intrauterine system was better than norethisterone with marked clinical benefit of profound reduction in menstrual blood loss.

  15. Clinical, endoscopical and morphological efficacy of mesalazine in patients with irritable bowel syndrome

    Directory of Open Access Journals (Sweden)

    Dorofeyev AE

    2011-06-01

    Full Text Available Andrey E Dorofeyev1, Elena A Kiriyan2, Inna V Vasilenko1, Olga A Rassokhina1, Andrey F Elin11National Medical University, Donetsk, Ukraine; 2Gastroenterological Center of Poltava Hospital Clinic, Poltava, UkraineObjectives: The aim of this study was to analyze the clinical efficacy and cytomorphologic changes of colon mucosa following the treatment of patients suffering from irritable bowel syndrome (IBS with mesalazine (5-aminosalicylic acid [5-ASA].Methods: In this controlled, randomized, blind clinical trial, a total of 360 patients with varying subtypes of IBS were randomly treated with 500 mg of mesalazine qid or by standard therapy without mesalazine for a period of 28 days. Pre- and post-treatment pain intensity, pain duration, meteorism, stool abnormalities and endoscopic parameters were monitored, and biopsies or brush biopsies were examined histologically.Results: Treatment of IBS patients with mesalazine significantly reduced intensity and duration of pain in all subtypes of IBS, except for duration of pain in the subtype “undifferentiated”, where the difference was not significant. In addition, in patients with diarrhea type and undifferentiated type of IBS, mesalazine also significantly reduced the abnormal stool pattern. In comparison to the control group, administration of mesalazine reduced the incidence of endoscopic and cytomorphologic changes of the bowel mucosa, including changes in colon mucus, mucus production, cytologic or histologic parameters, epithelial cell degeneration, appearance of leukocytes and macrophages and cell infiltrations.Conclusion: Mesalazine was effective in reducing several symptoms characteristic of IBS. It significantly reduced pain intensity and duration and improved cytohistologic parameters of the bowel mucosa.Keywords: 5-amino salicylic acid, 5-ASA, abdominal pain, irritable bowel syndrome, IBS, meteorism, stool abnormalities

  16. Efficacy and safety of telavancin in clinical trials: a systematic review and meta-analysis.

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    Konstantinos A Polyzos

    Full Text Available INTRODUCTION: The epidemiology and antibiotic resistance of Staphylococcus aureus have evolved, underscoring the need for novel antibiotics, particularly against methicillin-resistant S. aureus (MRSA. Telavancin is a bactericidal lipoglycopeptide with potent activity against Gram-positive pathogens. OBJECTIVE: To systematically review and synthesize the available evidence from randomized controlled trials (RCTs evaluating telavancin in the treatment of patients with infections due to Gram-positive organisms with the methodology of meta-analysis. RESULTS: Six RCTs comparing telavancin with vancomycin were included; 4 (2229 patients referred to complicated skin and soft tissue infections (cSSTIs and 2 (1503 patients to hospital-acquired pneumonia (HAP. Regarding cSSTIs, telavancin and vancomycin showed comparable efficacy in clinically evaluable patients (odds ratio [OR] =1.10 [95% confidence intervals: 0.82-1.48]. Among patients with MRSA infection, telavancin showed higher eradication rates (OR=1.71 [1.08-2.70] and a trend towards better clinical response (OR=1.55 [0.93-2.58]. Regarding HAP, telavancin was non-inferior to vancomycin in terms of clinical response in two Phase III RCTs; mortality rates for the pooled trials were comparable with telavancin (20% and vancomycin (18.6%. Pooled data from cSSTIs and HAP studies on telavancin 10 mg/kg indicated higher rates of serum creatinine increases (OR=2.22 [1.38-3.57], serious adverse events (OR=1.53 [1.05-2.24], and adverse event-related withdrawals (OR=1.49 [1.14-1.95] among telavancin recipients. CONCLUSION: Telavancin might be an alternative to vancomycin in cases of difficult-to-treat MRSA infections. The potent antistaphylococcal activity of telavancin should be weighted against the potential for nephrotoxicity.

  17. Clinical efficacy and pharmacokinetics of levothyroxine suppository in patients with hypothyroidism.

    Science.gov (United States)

    Kashiwagura, Yasuharu; Uchida, Shinya; Tanaka, Shimako; Watanabe, Hiroshi; Masuzawa, Masahiro; Sasaki, Tadanori; Namiki, Noriyuki

    2014-01-01

    This study aimed to elucidate the clinical efficacy and pharmacokinetics of levothyroxine (LT4) suppository, thus, we examined the pharmacokinetics of thyroxine (T4) after the administration of the suppository in thyroidectomized rats and examined dose and the levels of free T4 (FT4) in patients with hypothyroidism receiving suppositories. Thyroidectomized rats were administered with LT4 solution and LT4 suppository (30 µg/kg), and plasma T4 concentrations were measured using LC/MS. The AUC0-168 of T4 after rectal administration of the LT4 suppository was 64% lower than these values after oral administration. To evaluate clinical effect of LT4 suppository, we enrolled 6 Japanese patients with hypothyroidism (2 men and 4 women; age, 68.2±13.5 years) who were administered LT4 suppository at Kameda Medical Center from 2007 to 2013 in this case series. The FT4 level during the administration of suppositories was significantly lower than that during the administration of tablets (0.657±0.183 ng/dL vs. 1.25±0.51 ng/dL, p=0.034). The FT4/dose ratio for the suppository was significantly 44% lower than that for the tablet (p=0.020). In conclusion, although the bioavailability of LT4 is lower after administration of the suppository than after the oral formulation, it was suggested that T4 levels can be maintained in patients with hypothyroidism by administering LT4 suppositories at a dose 1.8 times higher than that of the tablet. Thus, the administration of LT4 suppository can be an alternative for treatment with oral medication in clinical practice.

  18. Effectiveness of group cognitive–behavioral treatment for childhood anxiety disorders in community clinics: benchmarking against an efficacy trial at a university clinic

    DEFF Research Database (Denmark)

    Jónsson, Hjalti; Arendt, Kristian Bech; Jørgensen, Lisbeth

    Background: The efficacy of a group cognitive behavioural therapy program (Cool Kids) of childhood anxiety has been demonstrated in a university-clinic setting in Australia (Hudson et al., 2009) and findings from a randomized controlled trial (RCT) at a University-clinic supports its efficacy...... Service in Denmark. Method: Psychologists and psychiatrists from three Child and Adolescent Psychiatry clinics and four community bases School Counselling Services are trained and supervised in a manualized group CBT treatment program (Cool Kids) for Childhood anxiety. Ninety-six children with anxiety...... disorders aged between 7 - 14 are expected to be included, equally divided between Psychiatric clinics (n = 48) and School Counselling services (n =48). The treatment consists of 10 2-hour group sessions with 5-6 children and their parents. Results are measured by independent diagnostic interviews...

  19. Patterns of analgesic use, pain and self-efficacy: a cross-sectional study of patients attending a hospital rheumatology clinic

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    Greenfield Sheila

    2009-11-01

    Full Text Available Abstract Background Many people attending rheumatology clinics use analgesics and non-steroidal anti-inflammatories for persistent musculoskeletal pain. Guidelines for pain management recommend regular and pre-emptive use of analgesics to reduce the impact of pain. Clinical experience indicates that analgesics are often not used in this way. Studies exploring use of analgesics in arthritis have historically measured adherence to such medication. Here we examine patterns of analgesic use and their relationships to pain, self-efficacy and demographic factors. Methods Consecutive patients were approached in a hospital rheumatology out-patient clinic. Pattern of analgesic use was assessed by response to statements such as 'I always take my tablets every day.' Pain and self-efficacy (SE were measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC and Arthritis Self-Efficacy Scale (ASES. Influence of factors on pain level and regularity of analgesic use were investigated using linear regression. Differences in pain between those agreeing and disagreeing with statements regarding analgesic use were assessed using t-tests. Results 218 patients (85% of attendees completed the study. Six (2.8% patients reported no current pain, 26 (12.3% slight, 100 (47.4% moderate, 62 (29.4% severe and 17 (8.1% extreme pain. In multiple linear regression self efficacy and regularity of analgesic use were significant (p Low SE was associated with greater pain: 40 (41.7% people with low SE reported severe pain versus 22 (18.3% people with high SE, p Conclusion Our study confirms that there is a strong inverse relationship between self-efficacy and pain severity. Analgesics are often used irregularly by people with arthritis, including some reporting severe pain.

  20. 地西他滨联合改良CAG及单倍体相合外周血淋巴细胞回输治疗老年高危恶性血液病%Clinical Efficacy of Decitabine plus Improved CAG Chemotherapy and Haplo-identical Donor Peripheral Lymphocyte Infusion Regimen on Elderly Patients with High Risk Myelodysplastic Syndrome and Acute Myeloid Leukemia

    Institute of Scientific and Technical Information of China (English)

    窦立萍; 靖琙; 王全顺; 梅俊辉; 于力

    2013-01-01

    本研究旨在观察地西他滨联合改良CAG及单倍体相合外周血淋巴细胞回输免疫治疗新方案,作为初治老年高危骨髓增生异常综合征(MDS)和急性髓系白血病(AML)的诱导缓解方案的初步疗效及其不良反应.对2012年4月至2012年7月在本院血液科应用地西他滨联合改良CAG及HLA半相合外周血淋巴细胞回输免疫治疗新方案治疗的5例老年高危MDS和AML患者进行前瞻性研究,观察完全缓解率及副反应.结果表明:5例初治老年患者治疗总有效率100%,4例达到完全缓解,1例患者达到部分缓解.既往无MDS病史患者,中性粒细胞数恢复至0.5×109/L的中位时间为15d,血小板数恢复至20×109/L的中位时间为16 d.主要副作用为IV度骨髓抑制,全部患者治疗中无新发肺部感染等严重并发症.结论:地西他滨联合改良CAG及外周血淋巴细胞回输免疫治疗新方案,治疗老年MDS和AML患者安全有效,值得进一步研究.%This study was aimed to observe the clinical efficacy and adverse effects of decitabine plus improved CAG chemotherapy and haploid-identical donor peripheral lymphocyte infusion regimen on elderly patients with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML).Five elderly patients with MDS and AML were treated with decitabine plus improved CAG chemotherapy and donor peripheral lymphocyte infusion regimen.Examinations on liver and renal function,electrocardiogram and bone marrow analysis were performed before and after treatment,and adverse effects were observed.The results indicated that after a course of treatment by decitabine plus improved CAG chemotherapy and haplo-identical donor peripheral lymphocyte infusion regimen,the total effective rate was 100%,and 4 patients (80%) achived complete remission,1 patient achived partial remission.The dominant clinical adverse effect was bone marrow depression,the median time of neutrophil >0.5 × 109/L and platelet >20 × 109/L was

  1. Observation of the clinical efficacy of Shenfuyishen Capsule in the treatment of diabetic nephropathy in high altitude regions%参附益肾胶囊治疗高海拔地区糖尿病肾病的临床观察

    Institute of Scientific and Technical Information of China (English)

    王文娟; 邓鑫

    2015-01-01

    目的:观察参附益肾胶囊治疗高海拔地区阳虚血瘀型糖尿病性肾病的临床疗效。方法将53例患者随机分为2组,治疗组31例,对照组22例。对照组西医常规治疗;治疗组在对照组基础上给予参附益肾胶囊,观察两组的临床疗效及患者血生化改变情况,如血肌酐(creatinine,SCr)、谷氨酸转氨酶(alanine aminotransferase,ALT)、血尿酸(uric acid,UA)、尿微量蛋白(urinary microalbumin,MALB)、肾小球滤过率(glomerular filtration rate,GFR)等指标。结果治疗组总有效率90.32%,对照组81.82%,两组比较,有显著性差异(P <0.05)。两组治疗后主要症状均有不同程度改善,与治疗前比较,有显著性差异(P <0.05)。治疗组治疗前后 ALT 无差异,治疗前后两组的 CR、UA、MALB、GFR 有差异,且治疗组改善更为显著,与对照组比较,有显著性差异(P <0.05)。结论参附益肾胶囊具有改善主要临床症状,降低糖尿病肾病患者 CR、GFR、UA、MALB 水平,从而保护肾功能,延缓糖尿病性肾病进程的作用。%Objective To observe the clinical efficacy of Shenfuyishen Capsule in the treatment of diabetic nephropathy of yangxuxueyu type in high- altitude regions.Methods We divided 53 patients randomly into two groups:31 in the observation group and 22 in the control group.Patients in the control group were treated with conventional regime of Western Medicine.Those in treatment group were given extra treatment with Shenfuyishen Capsule.Then we tested serum creatinine (Scr ),uric acid (UA),urinary microalbumin (MALB )and GFR. Results The total efficiency was 90.32% and 81.82% in the treatment group and the control group,which was significantly different (P < 0.05 ).Major symptoms improved after treatment in both groups,which differed significantly compared with those before treatment (P <0.05).ALT in the treatment group was not different after treatment.CR,UA,MALB and GFR significantly differed before and after treatment in

  2. COMPARATIVE EVALUATION OF CLINICAL EFFICACY AND SA FETY OF SALBUTAMOL AND LEVOSALBUTAMOL MDI IN PATIENTS OF BRONCHIAL ASTHMA

    Directory of Open Access Journals (Sweden)

    Hitender

    2013-02-01

    Full Text Available PURPOSE: Salbutamol is the most common β2-agonist being cur rently used in the treatment of asthma. It was only available as a racemate, a 50:5 0 mixture of the dextro [(S-salbutamol] and levo [(R-salbutamol] rotatory forms. Regular and e xcessive use of racemate can induce paradoxical reactions in some subjects with asthma. The present study, compared MDI Salbutamol with levo [(R-salbutamol] isomer over 8 weeks in terms of clinical efficacy and safety. METHODS: A prospective, parallel design, comparative study last ing eight weeks, involving 80 patient of either sex after taking thei r informed consent. Patients were randomly divided into 2 groups, A and B of 40 patients each. P atients in Group A and Group B were administered Salbutamol MDI two puffs 100 mcg per puf f four times daily and Levosalbutamol MDI two puffs each containing 50 mcg four times dail y respectively. Rescue dose two or more puffs was allowed as required and the number of addi tional doses were counted by patients. Observations were made and analyzed at 0, 4 and 8 w eeks for FEV1, FVC, and PEFR and side effects. RESULTS: Highly significant (p < 0.001 mean percent change in FEV1, FVC and PEFR at 4 and 8 weeks of Group B (Levosalbutamol patients as compared to mean percent change in FEV1 of Group A (Salbutamol patients at 4 weeks and 8 weeks. CONCLUSION: High therapeutic efficacy was observed with the use of the Levosalbu tamol MDI with lesser side effects.

  3. CLINICAL EVALUATION OF EFFICACY OF SERTACONAZOLE 2% CREAM IN TREATMENT OF PITYRIASIS VERSICOLOR AND A COMPARISION WITH THAT OF CLOTRIMAZOLE 1% CREAM

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    Lakshmi Tatavarthi

    2015-04-01

    Full Text Available BACKGROUND: Pityriasis versicolor is a mild superficial, chronic recurrent fungal infection. Many topical agents have been used with varying degree of success and high recurrence rate. The current study was conducted to clinically evaluate the efficacy of sertaconazole 2% in treating and preventing recurrences of pityriasis versicolor as compared to clotrimazole1%cream. AIMS: Clinical evaluation of the efficacy of sertaconazole 2% cream in the treatment of pityriasis versicolor and its comparison with that of clotrimazole 1% cream. MATERIALS & METHODS: 110 patients who were diagnosed clinically and microscopically as pityriasis versicolor and fulfilling the criteria were enrolled, of which 55 were treated with 2% sertaconazole cream and 55 with 1% clotrimazole cream twice daily for 4 weeks. At the end of fourth week patients were examined both clinically and mycologically. Follow up was done at 6 weeks to note any relapse clinically and mycologically. RESULTS : Out of 110 patients 4 patients using sertaconazole, 6 patients using clotri mazole were lost for follow - up and excluded from the study. Global assessment was done at the end of treatment i.e., 4 weeks with clinical and mycological cure rate, revealed that 42(82.3% of the sertaconazole group, 30(61.2% of the clotrimazole group we re improved clinically. Mycological examination at the same time was negative in 44(86.3%, 33(67.4% respectively. 7(13.7% of sertaconazole group, 12(24.48% of clotrimazole group show no significant change. 4(8.16% patients using clotrimazole complaine d of deterioration of symptoms but none using sertaconazole. CONCLUSION : Comparing the results obtained in this trial showed that sertaconazole was more efficacious than clotrimazole in the treatment of pityriasis versicolor because of its direct membrane damaging effect. But in terms of pigmentary resolution sertaconazole is not comparable to clotrimazole cream due to persistent effect of azelic acid.

  4. Clinical Comparative Study: Efficacy and Tolerability of Tolperisone and Thiocolchicoside in Acute Low Back Pain and Spinal Muscle Spasticity

    OpenAIRE

    Rao, Rajeev; Panghate, Atul; Chandanwale, Ajay; Sardar, Indrajeet; Ghosh, Mriganka; Roy, Modan; Banerjee, Bireswar; Goswami, Ankur; Kotwal, Prakash P

    2012-01-01

    Study Design We performed a multicentric, randomized, comparative clinical trial. Eligible patients were randomly assigned to receive 150 mg of Tolperisone thrice daily or 8 mg of Thiocolchicoside twice daily for 7 days. Purpose To assess the efficacy and tolerability of Tolperisone in comparison with Thiocolchicoside in the treatment of acute low back pain with spasm of spinal muscles. Overview of Literature No head on clinical trial of Tolperisone with Thiocolchicoside is available and so t...

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

    Science.gov (United States)

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

    2008-01-01

    Child-focused and family-focused cognitive-behavioral therapy (CBT) for 128 children with clinical anxiety disorders and their parents were compared in terms of efficacy and partial effectiveness. Results indicate that 53% of the children under the child CBT became free of anxiety disorders at posttreamtent compared to only 28% under family CBT.…

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

    Science.gov (United States)

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

    2008-01-01

    Child-focused and family-focused cognitive-behavioral therapy (CBT) for 128 children with clinical anxiety disorders and their parents were compared in terms of efficacy and partial effectiveness. Results indicate that 53% of the children under the child CBT became free of anxiety disorders at posttreamtent compared to only 28% under family CBT.…

  7. Clinical efficacy of zanolimumab (HuMax-CD4): two phase 2 studies in refractory cutaneous T-cell lymphoma

    DEFF Research Database (Denmark)

    Kim, Youn H; Duvic, Madeleine; Obitz, Erik

    2007-01-01

    The efficacy and safety of zanolimumab in patients with refractory cutaneous T-cell lymphoma (CTCL) have been assessed in two phase 2, multicenter, prospective, open-label, uncontrolled clinical studies. Patients with treatment refractory CD4(+) CTCL (mycosis fungoides [MF], n = 38; Sézary syndrome...

  8. The Efficacy of Thermotherapy and Cryotherapy on Pain Relief in Patients with Acute Low Back Pain, A Clinical Trial Study

    OpenAIRE

    DEHGHAN, MORTEZA; Farahbod, Farinaz

    2014-01-01

    Introduction: Acute low back pain is one of the most common health problems especially in industrialized countries where 75 per cent of the population develop it at least once during their life. This study examined the efficacy of thermotherapy and cryotherapy, alongside a routine pharmacologic treatment, on pain relief in patients with acute low back pain referring an orthopedic clinic in Shahrekord, Iran.

  9. Clinical characteristics of high grade foveal hypoplasia.

    Science.gov (United States)

    Park, Kyung-Ah; Oh, Sei Yeul

    2013-02-01

    To report clinical characteristics of high grade foveal hypoplasia. Patients with foveal hypoplasia of grade 3 or 4 on spectral domain optical coherence tomography according to a previously published scheme were enrolled. All patients underwent a full ophthalmologic assessment including visual acuity testing, slit lamp biomicroscopy, fundus examination, and evaluation of ocular alignment. The underlying causes of foveal hypoplasia were identified as albinism in five patients and aniridia in six patients. The mean logMAR visual acuity was 0.57 ± 0.24 (range 0.22-1.00) in the right eyes and 0.58 ± 0.21 (range 0.30-1.00) in the left eyes. On fundus examination in patients with albinism, two patients showed marked transparency, one patient showed moderate transparency, and two patients showed minimal transparency. Among six patients with aniridia, five patients showed normal macular pigmentation without macular reflex and one patient showed decreased macular pigmentation with no macular reflex. Patients with high grade macular hypoplasia tended to have poor visual acuities; however, the range of visual acuity was quite variable. Other factors associated with underlying disease could be the reason of this variability. Therefore, careful consideration should be given when assessing visual prognosis in foveal hypoplasia using optical coherence tomography.

  10. Randomised Clinical Efficacy Trial of Topiramate and Nitrazepam in Treatment of Infantile Spasms

    Directory of Open Access Journals (Sweden)

    Razieh FALLAH

    2014-01-01

    Full Text Available How to Cite This Article: Fallah R, Salor F, Akhavan Karbasi S, Motaghipisheh H. Randomised Clinical Efficacy Trial of Topiramate and Nitrazepam in Treatment of Infantile Spasms. Iran J Child Neurol. 2014 Winter; 8(1:12-19.ObjectiveInfantile spasms (IS are among the most catastrophic epileptic syndromes of infancy. The purpose of this study was to compare efficacy and safety of topiramate (TPM and nitrazepam (NZP as first-line drugs in the treatment ofIS.Materials & MethodsIn a parallel single-blinded randomized clinical trial, 50 patients with IS referred to Pediatric Neurology Clinic of Shahid Sadoughi University of Medical Sciences, Yazd, Iran, were evaluated from September 2008 to March 2010.Patients were randomly assigned to two groups to be treated with TPM or with NZP for 6 months. The primary endpoint was efficacy in cessation of all spasms or reduction of more than 50% in weekly seizure frequency, which was evaluatedbefore and 6 months after the drug use. Secondary outcome was clinical sideeffects of the drugs.ResultsTwenty boys (40% and 30 girls (60% with the mean age of 9.4±3.8 months were evaluated. Cessation of all spasms occurred in 12 (48% infants in TPM group and 4(16% in NZP group. Eight (32% children in TPM group and 7 (28% in NZP group had more than 50% reduction in spasms frequency. So,TPM was more effective. Side effects were seen in 32% of TPM and in 36% of NZP groups.ConclusionTopiramate is an effective and safe drug, which might be considered as the firstline drug for the treatment of ISs.References:Watemberg N. Infantile spasms: treatment challenges. Curr Treat Options Neurol 2012;14(4:322-31.Tsao CY. Current trends in the treatment of infantile spasms. Neuropsychiatr Dis Treat 2009;5:289-99.Sankar R, Koh S, Wu J, Menkes JH. Paroxysmal disorders. In: Menkes JH, Sarnat HB, Maria BL, editors Child Neurology,7th ed. Philadelphia: Lippincott; 2006.p. 877.Engel J Jr. International League against Epilepsy (ILAE

  11. Differences in the dynamics of serotonin reuptake transporter occupancy may explain superior clinical efficacy of escitalopram versus citalopram.

    Science.gov (United States)

    Kasper, Siegfried; Sacher, Julia; Klein, Nikolas; Mossaheb, Nilufar; Attarbaschi-Steiner, Trawat; Lanzenberger, Rupert; Spindelegger, Christoph; Asenbaum, Susanne; Holik, Alexander; Dudczak, Robert

    2009-05-01

    Escitalopram the S-enantiomer of the racemate citalopram, is clinically more effective than citalopram in the treatment of major depressive disorder. However, the precise mechanism by which escitalopram achieves superiority over citalopram is yet to be determined. It has been hypothesized that the therapeutically inactive R-enantiomer competes with the serotonin-enhancing S-enantiomer at a low-affinity allosteric site on serotonin reuptake transporters (SERTs), and reduces the effectiveness of the S-enantiomer at the primary, high-affinity serotonin-binding site. This study summarizes the results of two recent single-photon emission computerized tomography studies measuring SERT occupancy in citalopram-treated and escitalopram-treated healthy volunteers, after a single dose and multiple doses (i.e. under steady-state conditions). The single-dose study showed no attenuating effect of R-citalopram. After multiple dosing, however, SERT occupancy was significantly reduced in the presence of R-citalopram. Under steady-state conditions, R-enantiomer concentrations were greater than for the S-enantiomer because of slower clearance of R-citalopram. A pooled analysis suggests that build-up of the R-enantiomer after repeated citalopram dosing may lead to increased inhibition of S-enantiomer occupancy of SERT. This review adds to the growing body of evidence regarding differences in the dynamics of SERT occupancy, that is, molecular mechanisms underlying the often-observed superior clinical efficacy of escitalopram compared with citalopram in major depressive disorder.

  12. Clinical efficacy of diclofenac sodium and flunixin meglumine as adjuncts to antibacterial treatment of respiratory disease of calves.

    Science.gov (United States)

    Guzel, M; Karakurum, M C; Durgut, R; Mamak, N

    2010-06-01

    To compare the efficacy of the non-steroidal antiinflammatory drugs, diclofenac sodium and flunixin meglumine as adjuncts to the antibiotic treatment of bovine respiratory disease (BRD). We randomly allocated 80 Holstein calves with BRD to three groups. All the calves received a dose of 2.5 mg/kg tulathromycin by single subcutaneous injection and two of the groups received, in addition, either 2.5 mg/kg diclofenac sodium as a single intramuscular injection (diclofenac group, n = 30) or 2.2 mg/kg flunixin meglumine as an intravenous injection on the first three consecutive days after tulathromycin administration (flunixin group, n = 30). All calves were given a clinical score prior to initial treatment (day 0) and after treatment (days 1, 2, 3, 7 and 14) by observing appetite, demeanour, rectal temperature, the rate and type of respiration, presence or absence of coughing, and nasal discharge. During the first 48 h, improvement of adverse signs of respiratory disease, such as pyrexia and elevated respiratory rate, and of a high clinical index score was significant in the two adjunct groups compared with the calves receiving antibiotic alone. The reduction in pyrexia was greatest in the diclofenac group. There were no statically significant differences between treatment groups with regard to eventual perceived recovery from respiratory disease in 14 days. In this trial, a single intramuscular dose of diclofenac sodium was equally effective as three intravenous injections of flunixin meglumine given on consecutive days as adjunctive therapy for BRD.

  13. 'Pink eye' or 'zere oogjes' or keratoconjunctivitis infectiosa ovis (KIO). Clinical efficacy of a number of antimicrobial therapies.

    Science.gov (United States)

    König, C D

    1983-07-01

    In a comparative study the clinical efficacy of five different treatments of keratoconjunctivitis infectiosa ovis (KIO) were tested, namely an intramuscular injection of chloramphenicol base (dosage 15 mg/kg), spiramycin base (Suanovil dosages 10 to 25 mg/kg), oxytetracycline (Engemycine Forte, Terramycin LA, dosages respectively 5 and 10 mg/kg), tiamulin (Dynamutulin, dosage 10 mg/kg) and subcutaneous injection of procaine penicillin G, benzathine penicillin G. and dihydrostreptomycin in the lower eyelid. It appeared from these field trials that spiramycin base, oxytetracycline and tiamulin had a clearly positive effect on the clinical course of 'pink eye', although with tiamulin there was only a temporary effect (high percentage of relapses). In view of the field data the following dosage schemes are, for the time being, advised: spiramycin base (Suanovil), and oxytetracycline (formulation with a good biological availability) both 20 to 30 mg/kg and, if necessary, to be repeated on days 5 and 10 after the first intramuscular injection. The dosage scheme advised for tiamulin is 20-30 mg/kg to be repeated on day 3 and if necessary on days 6 and 9 after the intramuscular injection. In mild cases it is sufficient to rub the eyes with for example oxytetracycline eye-ointment, a few times a day.

  14. Exploring the Self-efficacy Beliefs among the High Achievers in Writing

    Directory of Open Access Journals (Sweden)

    Ilyana Jalaluddin

    2014-01-01

    Full Text Available Learners form their self-efficacy beliefs by interpreting information primarily from four sources namely performance accomplishments, vicarious experiences, verbal persuasion, and emotional arousal. It is important to recognize the four cognitive nature of self-efficacy because the cognitive appraisal of information from the four sources will influence self-efficacy and it cannot be evaluated based on one source per se (Lane, Jones & Stevens 2002. This article explores the four sources of self-efficacy among the high achievers in writing course. In analysing the finding, Z-scores were derived from each self-efficacy component score based on the aggregate mean and the standard deviation of the class. Findings show high frequency of negative z-value reported for Specific Progress (SPR and Social Feedback (SF. Meanwhile, high frequency of positive z-value is found in the General Progress (GPR and Physiological States (PS components. Based on the finding, pedagogical implications, limitations and directions for further research are presented.

  15. Telmisartan in daily clinical practice: Factors affecting efficacy in treatment of primary arterial hypertension

    Directory of Open Access Journals (Sweden)

    Bergovac M

    2009-01-01

    Full Text Available Background: Telmisartan provides effective treatment of hypertension in a broad spectrum of patients. Aims: To evaluate factors affecting the efficacy of telmisartan in daily clinical practice. Setting and Design: Prospective practice-based 12-week uncontrolled cohort study. Materials and Methods: Consecutive incident/prevalent outpatients with mild to moderate essential hypertension were started on telmisartan 40 mg/day with optional up-titration to 80 mg/day in order to achieve seated systolic (SSBP and diastolic (SDBP blood pressure < 140/90 mm Hg. Intent-to-treat (ITT, N=282 and per protocol (PP, N=275 efficacy assessment was based on SSBP/SDBP reduction and delivered doses. Results: SSBP/SDBP decreased (165.2±13.1 / 98.3±6.7 mm Hg to 137.9±13.2 / 82.6±7.3 mm Hg, whilst telmisartan was up-titrated in 40.5% of patients during the study. Multivariate (practically identical ITT and PP analysis indicated poorer response in obese vs. non-obese patients: lesser SDBP reduction (by around 2.2-2.3 mm Hg, P < 0.05 with higher odds of dose up-titration (odds ratio, OR around 1.90, P < 0.05; and better response in: a patients started on telmisartan monotherapy than when added to a preexisting treatment: greater SSBP/SDBP reduction (by around 4.0 and 3.0 mm Hg, respectively, P < 0.05 with comparable odds of up-titration; b diabetics vs. non-diabetics: greater SDBP reduction (by around 3.6-3.7 mm Hg, P < 0.05 with comparable odds of up-titration; c men vs. women: slightly greater SDBP reduction (by around 1.2 mm Hg, 0.05 P < 0.1 with lower odds of up-titration (OR around 0.51, P < 0.05. Conclusion: Previous unsuccessful treatment, obesity, diabetes and gender should be considered in order to optimize the use of telmisartan for mild to moderate essential hypertension in daily clinical practice.

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

    Science.gov (United States)

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

    2015-09-01

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

  17. Virological efficacy of PI monotherapy for HIV-1 in clinical practice

    Science.gov (United States)

    El Bouzidi, Kate; Collier, Dami; Nastouli, Eleni; Copas, Andrew J.; Miller, Robert F.; Gupta, Ravindra K.

    2016-01-01

    Background Clinical trials of PI monotherapy indicate that most participants maintain viral suppression and emergent protease resistance is rare. However, outcomes among patients receiving PI monotherapy for clinical reasons, such as toxicity or adherence issues, are less well studied. Methods An observational study of patients attending an HIV treatment centre in London, UK, who had received PI monotherapy between 2004 and 2013, was conducted using prospectively collected clinical data and genotypic resistance reports. Survival analysis techniques were used to examine the times to virological failure and treatment discontinuation. Results Ninety-five patients had PI monotherapy treatment for a median duration of 126 weeks. Virological failure occurred during 64% of episodes and 8% of patients developed emergent protease mutations. We estimate failure occurs in half of episodes within 2 years following initiation. Where PI monotherapy was continued following virological failure, 68% of patients achieved viral re-suppression. Despite a high incidence of virological failure, many patients continued PI monotherapy and 79% of episodes were ongoing at the end of the study. The type of PI used, the presence of baseline protease mutations and the plasma HIV RNA at initiation did not have a significant impact on treatment outcomes. Conclusions There was a higher incidence of virological failure and emerging resistance in our UK clinical setting than described in PI monotherapy clinical trials and other European observational studies. Despite this, many patients continued PI monotherapy and regained viral suppression, indicating this strategy remains a viable option in certain individuals following careful clinical evaluation. PMID:27402006

  18. High-dose rate brachytherapy as monotherapy in prostate cancer: A systematic review of its safety and efficacy.

    Science.gov (United States)

    Sánchez-Gómez, L M; Polo-deSantos, M; Rodríguez-Melcón, J I; Angulo, J C; Luengo-Matos, S

    2017-03-01

    High-dose rate brachytherapy (HDR-BT) is an increasingly popular treatment for patients with localised prostate cancer (PC). To assess the safety and efficacy of HDR-BT as monotherapy in PC. A systematic literature review was conducted through searches on MEDLINE (PubMed), Cochrane Library, CDR, ClinicalTrials and EuroScan. We assessed safety and efficacy indicators. We selected 2 reviews and 12 uncontrolled studies, included in these 2 reviews. In terms of efficacy, local control in 6 studies was 97-100%. The biochemical progression-free survival varied as follows: 85-100% for low risk and 79-92% for high risk. Survival free of metastases was >95% at 8 years, except in one study where the survival rate was 87% at 5 years. The overall survival was ≥95% in 8 studies. In terms of safety, most of the studies recorded acute and long-term genitourinary and gastrointestinal complications, especially grade ≥2. Only 3 studies found grade 4 complications. All studies, except for one without complications, observed genitourinary complications that were more frequent and severe than the gastrointestinal complications. Two studies assessed the quality of life and showed an initial reduction in various domains and subsequent partial or total recovery, except in the sexual domain. HDR-BT is effective as monotherapy, especially in cases of low to intermediate risk. There is insufficient information on high-risk patients. The short to medium-term toxicity was acceptable. Further research needs to be funded to provide more information on the long-term safety and efficacy of this treatment. Copyright © 2016 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

  19. 高剂量腺苷在急性ST段抬高心肌梗死直接经皮冠状动脉介入治疗中的应用效果评价%Clinical efficacy evaluation of the high dose adenosine through percutaneous coronary intervention in the treatment of the acute ST segment elevation myocardial infarction

    Institute of Scientific and Technical Information of China (English)

    马广隆; 苏伟青; 林振; 吴阿兰

    2016-01-01

    Objective:To evaluate the clinical efficacy of high dose adenosine through percutaneous coronary intervention in the treatment of the acute ST segment elevation myocardial infarction. Methods:Eighty-two patients with acute ST segment elevation myocardial infarction were randomly divided into the study group and control group(42 cases each group). All patients were treated with percutaneous coronary intervention( PCI) . The study group and control group were treated with 600μg of adenosine combined with 10 mL of saline and 300 μg of adenosine combined with 10 mL of saline for 1 min,respectively,then two groups were additionally treated with stenting. Coronary flow of infarction related artery ( IRA ) was assessed after treatment. The serum levels of creatine kinase, isoenzyme of creatine kinase and cardiac troponin I,drop rate of ST segment elevation and left ventricular ejection fraction between two groups were compared after operation. Results:The biochemical and ECG indexes in study group were significantly better than those in control group after treatment(P0. 05). The TIMI rating in study group at the end of operation was better than that in control group(P0. 05). Conclusions:The treatment of the acute ST segment elevation myocardial infarction with the high dose of adenosine through percutaneous coronary intervention is safe and effective, which has certain application value.%目的::评价高剂量腺苷在急性ST段抬高心肌梗死直接经皮冠状动脉介入治疗中的应用效果。方法:ST段抬高心肌梗死患者84例,随机分为研究组和对照组各42例。所有患者均直接进行经皮冠状动脉介入治疗,研究组即刻给予腺苷600μg+0.9%氯化钠注射液10 mL,对照组即刻给予腺苷300μg+0.9%氯化钠注射液10 mL,均持续冠状动脉内注射1 min再给予支架,术毕进行再通后血流评价,并比较肌酸激酶、肌酸激酶同工酶、肌钙蛋白I等生化指标和术后心电图ST段抬高回落率

  20. High efficacy of gemifloxacin-containing therapy in Helicobacter Pylori eradication

    Science.gov (United States)

    Mahmoudi, Laleh; Farshad, Shohreh; Seddigh, Mehrdad; Mahmoudi, Paria; Ejtehadi, Fardad; Niknam, Ramin

    2016-01-01

    Abstract Background: Helicobacter pylori (H pylori) is a common gastric pathogen which is associated with chronic gastritis, peptic ulcer, and gastric cancer. It has worldwide distribution with higher incidence in developing countries. Gemifloxacin is a fluoroquinolone antibiotic with documented in vitro activity against H pylori. Considering that there is no clinical data to verify gemifloxacin efficacy in H pylori eradication, this pilot clinical trial was designed. Methods: This prospective pilot study was performed during February 2014 to February 2015. A regimen of gemifloxacin (320 mg single dose) plus twice daily doses of amoxicillin1g, bismuth 240 mg, and omeprazole 20 mg for 14 days were prescribed for H pylori infected patients in whom a first-line standard quadruple therapy (clarithromycin–amoxicillin–bismuth–omeprazole) had failed. To confirm H pylori eradication a 13C-urea breath test was performed 4 weeks after treatment. Compliance and incidence of adverse effects were evaluated by questionnaires. Results: A total of 120 patients were enrolled consecutively; out of which 106 patients achieved H pylori eradication; per-protocol and intention-to-treat eradication rates were 91.4% (95% CI: 85.5–97.6) and 88.3% (95% CI: 75.4–92.4) respectively. Three patients (2.5%) failed to take at least 80% of the drugs and excluded from the final analysis. Adverse effects were reported in 42% of patients, most commonly including nausea (15%) and diarrhea (13.3%), which was intense in 1 patient and led to the discontinuation of treatment. In total, 96.7% (116/120) of the patients took the medications correctly. Conclusion: This study revealed that gemifloxacin-containing quadruple therapy provides high H pylori eradication rate (≥90% PP cure rate), and this agent can be included in the list of second-line H pylori therapeutic regimens. PMID:27759625

  1. Clinical factors influencing the efficacy of lung recruitment maneuver with high-level PEEP in patients with 2009 influenza A (H1N1)-associated acute respiratory distress syndrome%影响甲型H1N1流感病毒性肺炎所致ARDS患者肺复张效果的因素探讨

    Institute of Scientific and Technical Information of China (English)

    刘晓伟; 靳妍; 刘志

    2014-01-01

    Objective To investigate the clinical factors dominant in the efficacy of lung recruitment maneuver (RM) with high-level positive end-expiratory pressure (PEEP) under pressure control ventilation in patients with 2009 influenza A (H1N1)-associated acute respiratory distress syndrome (ARDS) by analyzing the clinical data of 24 patients treated with mechanical ventilation.Methods A retrospective study was carried out in a 16-bed capacity emergency intensive care unit (EICU) of the First Affiliated Hospital of China Medical University from October 2009 to January 2010.Twenty-four patients with influenza-associated ARDS were included.During pressure control ventilation,when SpO2 persisted lower than 88% for more than 30 min,RM with high-level PEEP was initiated to normalize lung volume at 30 cmH2O for 60 s.The RM was responded as SpO2 increased more than 3% within 15 min; otherwise,the increase below 3% in SpO2 would be considered non-responded.Variations in respiratory mechanics,oxygen metabolism and hemodynamic parameters were measured before and after RM.Results Of 24 patients with influenza-associated ARDS,16 survived and 8 deceased.The median duration of mechanical ventilation (DMV) in EICU was 5.5 days (range from 3.5 to 12.0 days).During the entire study period,a total of 158 RMs with high-level PEEP were done,including 76 (48.1%) responded RMs (the responded group) and 82 (51.9%) non-responded RMs (the non-responded group).In survivor group,the ratio of effective RM was higher than in nonsurvivors group (66.2% vs.33.3%,P < 0.01).Compared with the data before RM,HR was increased (92.6 ± 11.8) vs.(73.0 ± 12.6),P =0.038 and MAP was decreased (66.1 ±9.3) mmHg vs.(73.9 ± 11.4) mmHg,P=0.049 during RM,and these difference were not statistically significant at 3 min after RM.The decrease in SpO2 after 134 procedures of RMs in 85.9% patients,and the minimum value of SpO2 occurred at (2.1 ±0.6) min after RM.In the responded group,the maximum SpO2

  2. A randomized controlled clinical study evaluating the efficacy of two desensitizing dentifrices.

    Science.gov (United States)

    Salian, Sowmya; Thakur, Srinath; Kulkarni, Sudhindra; LaTorre, Guy

    2010-01-01

    The primary aim of this study was to compare the in vivo efficacy and safety of dentifrices containing either 5% NovaMin or 5% potassium nitrate, and a non-desensitizing dentifrice, on dentin hypersensitivity in a four-week, double-blind clinical study among a population in south India. In addition, a companion scanning electron microscopy evaluation was performed to demonstrate whether or not the test products occlude open dentin tubules in vitro. Thirty volunteers with tooth sensitivity were recruited, and a double-blind, randomized, parallel, controlled clinical trial was conducted in a hospital setting. Clinical evaluation for dentin hypersensitivity was done using tactile, air blast, and cold water methods. Following baseline measures, subjects were randomly divided into three groups and treated as follows: Group A--dentifrice containing 5% potassium nitrate; Group B--dentifrice containing 5% NovaMin; and Group C--dentifrice containing no desensitizing ingredients. Clinical evaluations were repeated after two and four weeks of product use. Compared to baseline, there was a significant decrease in dentin hypersensitivity in Groups A and B following four weeks' use of the dentifrice containing 5% potassium nitrate and the dentifrice containing 5% calcium sodium phosphosilicate (NovaMin), respectively. There was a statistically greater reduction in hypersensitivity at both two and four weeks following use of the dentifrice containing NovaMin compared with the use of a non-desensitizing dentifrice, as well as the dentifrice containing potassium nitrate. Air and cold water scores were significantly lower following four weeks' use of the potassium nitrate dentifrice compared to the non-desensitizing dentifrice. Tubule occlusion was observed in the companion in vitro study following treatment with 5% NovaMin, but not after treatment with the 5% potassium nitrate or non-desensitizing dentifrices. The results suggest that the dentifrice containing 5% NovaMin occludes

  3. Clinical and Radiographic Assessment of the Efficacy of Calcium Silicate Indirect Pulp Capping

    Science.gov (United States)

    Hashem, D.; Mannocci, F.; Patel, S.; Manoharan, A.; Brown, J.E.; Watson, T.F.

    2015-01-01

    The aims of this study were to assess the effectiveness of calcium silicate cement (Biodentine) versus glass ionomer cement (GIC; control group) as indirect pulp capping materials in patients with reversible pulpitis and to compare the effectiveness of cone beam computed tomography (CBCT) versus periapical (PA) radiographs in detecting PA changes at baseline (T0) and at 12 mo (T12) postoperatively. Seventy-two restorations (36 Biodentine, 36 Fuji IX) were placed randomly in 53 patients. CBCT/PA radiographs were taken at T0 and T12. Two calibrated examiners assessed the presence/absence and increase/decrease in the size of existing PA radiolucencies under standardized conditions. The Kappa coefficient evaluated statistically the effectiveness of CBCT versus PA radiographs in detecting PA changes. Chi-square/Mann-Whitney tests were used to evaluate the association between PA changes in CBCT with various clinical measures. Significance was predetermined at α = 0.05. Clinical success rates for Biodentine and Fuji IX GIC were 83.3%. CBCT was significantly more effective in detecting PA radiolucencies compared with radiographs (P = 0.0069). Of the teeth, 65.4% and 90.4% were deemed healthy using CBCT and PA radiographs, respectively, at T12. Healing/healed rates were 17.3%/0%, while new/progressed radiolucency were 30.8%/9.6% with CBCT/PA radiographs, respectively. Seventy-one percent of healed lesions had received Biodentine; 88% of new/progressed lesions received Fuji IX GIC. Teeth presenting with an initial CBCT PA lesion had a failure rate of 63%, whereas teeth with no initial lesion had a failure rate of 16%. Although no statistically significant difference was detected in the clinical efficacy of Biodentine/Fuji IX when used as indirect pulp capping materials in patients with reversible pulpitis, CBCT showed a significant difference in that most healed CBCT lesions had received Biodentine while most that did not heal received Fuji IX. Longer-term follow-up is

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

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    Rodolfo Augusto Matteo Ambiel

    2016-01-01

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

  5. Selective Embolization for Post-Endoscopic Sphincterotomy Bleeding: Technical Aspects and Clinical Efficacy

    Energy Technology Data Exchange (ETDEWEB)

    So, Young Ho; Choi, Young Ho [Seoul National University Boramae Medical Center, Seoul (Korea, Republic of); Chung, Jin Wook; Jae, Hwan Jun; Park, Jae Hyung [Seoul National University Hospital, Seoul (Korea, Republic of); Song, Soon Young [Hanyang University Hospital, Seoul (Korea, Republic of)

    2012-01-15

    The objective of this study was to evaluate the technical aspects and clinical efficacy of selective embolization for post-endoscopic sphincterotomy bleeding. We reviewed the records of 10 patients (3%; M:F 6:4; mean age, 63.3 years) that underwent selective embolization for post-endoscopic sphincterotomy bleeding among 344 patients who received arteriography for nonvariceal upper gastrointestinal bleeding from 2000 to 2009. We analyzed the endoscopic procedure, onset of bleeding, underlying clinical condition, angiographic findings, interventional procedure, and outcomes in these patients. Among the 12 bleeding branches, primary success of hemostasis was achieved in 10 bleeding branches (83%). Secondary success occurred in two additional bleeding branches (100%) after repeated embolization. In 10 patients, post-endoscopic sphincterotomy bleedings were detected during the endoscopic procedure (n = 2, 20%) or later (n = 8, 80%), and the delay was from one to eight days (mean, 2.9 days; {+-} 2.3). Coagulopathy was observed in three patients. Eight patients had a single bleeding branch, whereas two patients had two branches. On the selective arteriography, bleeding branches originated from the posterior pancreaticoduodenal artery (n = 8, 67%) and anterior pancreaticoduodenal artery (n = 4, 33%), respectively. Superselection was achieved in four branches and the embolization was performed with n-butyl cyanoacrylate. The eight branches were embolized by combined use of coil, n-butyl cyanoacrylate, or Gelfoam. After the last embolization, there was no rebleeding or complication related to embolization. Selective embolization is technically feasible and an effective procedure for post-endoscopic sphincterotomy bleeding. In addition, the posterior pancreaticoduodenal artery is the main origin of the causative vessels of post-endoscopic sphincterotomy bleeding.

  6. Efficacy of the Dynamic Interspinous Assisted Motion system in clinical treatment of degenerative lumbar disease

    Institute of Scientific and Technical Information of China (English)

    ZHAO Yu; WANG Yi-peng; QIU Gui-xing; ZHAO Hong; ZHANG Jian-guo; ZHOU Xi

    2010-01-01

    Background The Dynamic Interspinous Assisted Motion (DIAM) system was designed to stabilize degenerative spinal segments without fusion surgery, maintain segment motion and prevent adjacent segment degeneration. The aim of thisstudy was to investigate clinical efficacy of the DIAM system in treatment of degenerative lumbar disease in China.Methods Eight cases of lumbar vertebral instability were treated with the DIAM system at Peking Union MedicalCollege Hospital from June 2006 to January 2008. There were 6 female and 2 male subjects with a mean age of 46.9years and a range of 40-52 years. Radiographs and scores on outcome measures included the visual analogue scale (VAS) for pain and the Oswestry disability index (ODI). These scores were recorded before surgery and after surgery at intervals of 3-month, 6-month, 1-year and the final follow-up visit.Results The follow-up time ranged from 12-31 months, with an average of 20.6 months. There were significant differences between preoperative and postoperative scores at each follow-up evaluation (P <0.05). However, there was no significant difference between each postoperative follow-up score (P >0.05). There were significant differences between preoperative and postoperative L4-5 segment activity at each time interval (P <0.05), but no obvious difference was found within each postoperative follow-up evaluation (P >0.05). The ODI and VAS score improvements were directly correlated with segment activity (r >0.7, P <0.05).Conclusions The DIAM system appears to be a useful and effective treatment in the surgical management of degenerative lumbar disease in certain patients. However, long-term follow-up is needed to evaluate the clinical outcomes of the device.

  7. Pharmacokinetics and clinical efficacy of phenobarbital in asphyxiated newborns treated with hypothermia: a thermopharmacological approach.

    Science.gov (United States)

    van den Broek, M P H; Groenendaal, F; Toet, M C; van Straaten, H L M; van Hasselt, J G C; Huitema, A D R; de Vries, L S; Egberts, A C G; Rademaker, C M A

    2012-10-01

    Therapeutic hypothermia can influence the pharmacokinetics and pharmacodynamics of drugs, the discipline which is called thermopharmacology. We studied the effect of therapeutic hypothermia on the pharmacokinetics of phenobarbital in asphyxiated neonates, and the clinical efficacy and the effect of phenobarbital on the continuous amplitude-integrated electroencephalography (aEEG) in a prospective study. Data were obtained from the prospective SHIVER study, performed in two of the ten Dutch level III neonatal intensive care units. Phenobarbital data were collected between 2008 and 2010. Newborns were eligible for inclusion if they had a gestational age of at least 36 weeks and presented with perinatal asphyxia and encephalopathy. According to protocol in both hospitals an intravenous (repeated) loading dose of phenobarbital 20 mg/kg divided in 1-2 doses was administered if seizures occurred or were suspected before or during the hypothermic phase. Phenobarbital plasma concentrations were measured in plasma using a fluorescence polarization immunoassay. aEEG was monitored continuously. A one-compartmental population pharmacokinetic/pharmacodynamic model was developed using a multi-level Markov transition model. No (clinically relevant) effect of moderate therapeutic hypothermia on phenobarbital pharmacokinetics could be identified. The observed responsiveness was 66%. While we still advise an initial loading dose of 20 mg/kg, clinicians should not be reluctant to administer an additional dose of 10-20 mg/kg. An additional dose should be given before switching to a second-line anticonvulsant drug. Based on our pharmacokinetic/pharmacodynamic model, administration of phenobarbital under hypothermia seems to reduce the transition rate from a continuous normal voltage (CNV) to discontinuous normal voltage aEEG background level in hypothermic asphyxiated newborns, which may be attributed to the additional neuroprotection of phenobarbital in infants with a CNV pattern.

  8. Clinical efficacy of transumbilical single-port laparoscopic cholecystectomy in treatment of acute cholecystitis

    Directory of Open Access Journals (Sweden)

    LIU Chao

    2015-10-01

    Full Text Available ObjectiveTo evaluate the clinical efficacy of transumbilical single-port laparoscopic cholecystectomy in patients with acute cholecystitis and the effect of this surgical procedure on the postoperative recovery of gastrointestinal function. MethodsThis study enrolled 74 patients who were diagnosed with acute cholecystitis at Yanan University Affiliated Hospital, Shaanxi Province, China, from January 2013 to February 2014. The patients received either transumbilical laparoscopic surgery (treatment group or conventional laparoscopic treatment (control group. Differences in operative time, intraoperative blood loss, rate of postoperative complications, time to first bowel sound, time to first flatus, time to ambulation, and hospital costs were compared between the two groups. Categorical data were compared using the χ2 test and continuous data were compared using the t test. ResultsNo significant difference was noted between the treatment group and the control group in terms of operative time (P>0.05. However, the treatment group had significantly lower blood loss (10.5±1.5 L, rate of postoperative complications (10.8%, and hospital costs (8218±389 yuan and significantly less time to first bowel sound (2.5±0.3 h, time to first flatus (1.6±4.1 h, and time to ambulation (9.7±5.8 h than the control group (all P<0.05. ConclusionTransumbilical single-port laparoscopic cholecystectomy is a safe and feasible procedure for the treatment of acute cholecystitis as it offers minimal trauma and fast recovery of gastrointestinal function after surgery, which warrants its greater use in clinical practice.

  9. Comparative efficacy of two treatment modalities for dentinal hypersensitivity: A clinical trial

    Directory of Open Access Journals (Sweden)

    Aparna S

    2010-01-01

    Full Text Available Background: Dentin hypersensitivity is a recurrent condition causing discomfort and sometimes pain to the patient, which also deters him from maintaining adequate oral hygiene. Home care and office measures are used for treatment of this malady. Aim: To evaluate and compare the efficacy of 2 treatment modalities for dentinal hypersensitivity, iontophoresis with acidulated phosphate gel (APF gel, and dentin-bonding agent application. Materials and Methods: This split mouth randomized clinical study recruited subjects with a history of hypersensitivity with at least 2 teeth, verified by a light stroke with a dental explorer along the cervical third of the teeth. The patients were subjected to a 1-s air blast and cold water stimuli and their responses were recorded on a verbal rating scale. A total of 30 sites from 15 patients were divided into Group A-1.23% APF gel iontophoresis; and Group B-aqueous solution of hydroxyl-ethyl-methacrylate and glutaraldehyde. The teeth were evaluated immediately after the treatment and at the end of 2 weeks. In case of failure, the tooth was retreated with the same agent as before. Results: The results were statistically analyzed using Kruskal-Wallis analysis of variance and Mann-Whitney U tests. There was no statistically significant difference between the groups at the end of 2 weeks. However, Group A was more effective clinically, with fewer number of failures compared with Group B. Conclusion: Both the agents showed a statistically significant reduction in sensitivity compared with baseline; however, APF gel iontophoresis was more effective in reducing hypersensitivity over a longer time period.

  10. Efficacy of current guidelines for the treatment of spontaneous bacterial peritonitis in the clinical practice

    Institute of Scientific and Technical Information of China (English)

    Stefania Angeloni; Cinzia Leboffe; Antonella Parente; Mario Venditti; Alessandra Giordano; Manuela Merli; Oliviero Riggio

    2008-01-01

    AIM:To verify the validity of the International Ascites Club guidelines for treatment of spontaneous bacterial peritonitis (SBP) in clinical practice.METHODS:All SBP episodes occurring in a group of consecutive cirrhotics were managed accordingly and included in the study.SBP was diagnosed when the ascitic fluid polymorphonuclear (PMN) cell count was>250 cells/mm3,and empirically treated with cefotaxime.RESULTS:Thirty-eight SBP episodes occurred in 32 cirrhotics (22 men/10 women;mean age:58.6±11.2 years).Prevalence of SBP,in our population,was 17%.Ascitic fluid culture was positive in nine (24%)cases only.Eleven episodes were nosocomial and 71%community-acquired.Treatment with cefotaxime was successful in 59% of cases,while 41% of episodes required a modification of the initial antibiotic therapy because of a less-than 25% decrease in ascitic PMN count at 48 h.Change of antibiotic therapy led to the resolution of infection in 87% of episodes.Among the cases with positive culture,the initial antibiotic therapy with cefotaxime failed at a percentage (44%) similar to that of the whole series.In these cases,the isolated organisms were either resistant or with an inherent insufficient susceptibility to cefotaxime.CONCLUSIOM:In clinical practice,ascitic PMN count is a valid tool for starting a prompt antibiotic treatment and evaluating its efficacy.The initial treatment with cefotaxime failed more frequently than expected.An increase in healthcare-related infections with antibiotic-resistant pathogens may explain this finding.A different first-line antibiotic treatment should be investigated.

  11. Clinical efficacy of rosuvastatin in lipid management in Chinese patients in Hong Kong

    Institute of Scientific and Technical Information of China (English)

    Vivian W.Y. Lee; T.S. Chau; Vice P.H. Leung; Kenneth K.C. Lee; Brian Tomlinson

    2009-01-01

    Background Rosuvastatin has been claimed to be more potent than other statins in its ability to lower the low-density lipoprotein (LDL) cholesterol levels. This study aimed to investigate the clinical efficacy of rosuvastatin in LDL cholesterol lowering therapy for new or switched hyperlipidaemic Chinese patients.Methods This study was a retrospective one in patients who took rosuvastatin in the outpatient clinics of Prince of Wales Hospital during the period of July 1,2004 to June 30, 2005. The prescribing pattern, the utilization pattern and the side effect profile were recorded. Attainment of lipid goals for each patient was assessed according to the National Cholesterol Education Program Adult Treatment Panel (NCEPATP) III guidelines.Results A total of 261 Chinese patients (mean age (64.8±12) years; 55.6% male) were recruited into the study. The mean LDL-cholesterol level was (3.50±1.29) mmol/L prior to Rosuvastatin and (2.30±1.73) mmol/L after Rosuvastatin treatment (P<0.0001). Rosuvastatin raised the LDL-cholesterol goal achievement rate from 28.0% to 74.3% in all patients combined (P<0.0001) and from 11.0% to 79.0% for statin naive patients (P<0.0001). Approximately 4% of patients developed side effects including myalgia, elevated liver enzymes, and dizziness.Conclusion Rosuvastatin was effective in improving LDL-cholesterol goal attainment and lowering LDL-cholesterol and triglyceride (TG) levels in either newly started or switched patients.

  12. Comparative Antibacterial Efficacy of Vitellaria paradoxa (Shea Butter Tree Extracts Against Some Clinical Bacterial Isolates

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    Kamoldeen Abiodun AJIJOLAKEWU

    2015-09-01

    Full Text Available The antibacterial activities of the ethanolic extracts of seed, leaf and stem bark of Vitellaria paradoxa were investigated. The extracts were tested against three clinical bacterial pathogens, Staphylococcus aureus, Escherichia coli and Klebsiella pneumoniae using the agar diffusion and the broth dilution techniques. Ethanolic extracts of the plant parts showed activity against all the bacterial pathogens tested. At the highest extract concentration (200 mg/ml, the leaf extract exhibited the highest antimicrobial activity, while no activity was detected at the lowest concentration (3.13 mg/ml against the tested isolates. Escherichia coli and Staphylococcus aureus were more susceptible to all extracts of V. paradoxa, while Klebsiella pneumoniae showed the least sensitivity. The efficacy of ethanolic extracts of Vitellaria paradoxa was compared to a commercial antibiotic streptomycin. There were differences in the minimum inhibitory concentration (MIC of all the Vitellaria paradoxa ethanolic extracts with respect to the type of organism. All extracts exhibited bacteriostatic effects against the tested organisms at the experimented concentrations. Qualitative phytochemical screening of the extracts revealed the presence of saponins, tannins and alkaloids as the active principles of Vitellaria paradoxa's antimicrobial activity. V. paradoxa could be used as a potential source of antibiotic substance for a drug development.

  13. Clinical efficacy of Ayurveda treatment regimen on Subfertility with Poly Cystic Ovarian Syndrome (PCOS).

    Science.gov (United States)

    Dayani Siriwardene, S A; Karunathilaka, L P A; Kodituwakku, N D; Karunarathne, Y A U D

    2010-01-01

    Poly Cystic Ovarian Syndrome (PCOS) is the most common endocrinopathy in women of reproductive age, resulting from insulin resistance and the compensatory hyperinsulinemia. This results in adverse effect on multiple organ systems and may result in alteration in serum lipids, anovulation, abnormal uterine bleeding and infertility. According to Ayurvedic view PCOS can be correlated with Aarthava Kshaya. It was revealed that most of subfertility patients who were presented Osuki Ayurveda Centre suffered from the PCOS. Therefore the present study was carried out for the clinical evaluation of the efficacy of Ayurveda treatment regimen on subfertility with PCOS. Total 40 patients were selected by using purposive sampling method. According to the Ayurveda theories of Shodhana, Shamana and Tarpana, the treatment was conducted in 3 stages for the duration of 6 months. The response to the treatment was recorded and therapeutic effects were evaluated by symptomatic relief and through Trans Vaginal Scan and LH, FSH hormone levels. The results revealed that, subfertility due to PCOS can be cured successfully by using this Ayurveda treatment regimen.

  14. Efficacy of an Unani Formulation in Reducing Post Inflammatory Acne Hyperpigmentation Marks- A Clinical Study

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    Shabiya Sultana

    2015-10-01

    Full Text Available There is no single malady which causes supplementary psychic disturbance and more general insecurity and feeling of inferiority than acne vulgaris with post inflammatory acne pigmentation marks does. It is strongly associated with depression and anxiety. In addition to individuals with little objective evidence acne with post inflammatory acne hyperpigmentation marks may endure severe subjective impairment, greatly affecting their health related quality of life. Unani System of Medicine contains treatise of basic and compound formulations that can be administered orally and locally in improving post inflammatory acne hyperpigmentation marks. To evaluate the efficacy of a poly herbal Unani formulation in improving post inflammatory acne hyperpigmentation marks. The study was observational self-comparison before and after treatment on 32 female patients. The separate powders of drugs; Shūnīz, Būra Armanī, Naushādar sieved and mixed with Sirka (vinegar and prepared a Unani formulation and were applied topically. All the patients were assessed for change in pigmentation marks of face by using “Visual arbitrary scale for acne hyperpigmentation marks”. In present study out of 32 acne patients 20 (62.5% reported decrease in acne hyperpigmentation marks. The effect of drug was significant (p<0.01 statistically and clinically both. In the present study it was concluded that the used Unani formulation was much effective in improving post inflammatory acne hyperpigmentation marks.

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

    Science.gov (United States)

    Ammari, Michelle Mikhael; Moliterno, Luiz Flávio Martins; Hirata Júnior, Raphael; Séllos, Mariana Canano; Soviero, Vera Mendes; Coutinho Filho, Wagner Pereira

    2014-01-01

    The aim of this study was to compare the efficacy of chemochemical methods (Carisolv™ and Papacárie®) versus the manual method (excavators) in reducing the cariogenic microbiota in dentine caries of primary teeth. Forty-six healthy children (5 to 9 years old) having at least one primary tooth with a cavitated dentine carious lesion were included in the study. The teeth presented no clinical or radiographic signs of pulpal involvement. The sample of 74 teeth was randomly divided into three different groups: Papacárie® (n = 25), Carisolv™ (n = 27) and Manual (n = 22). Samples of carious and sound dentine were collected with sterile excavators before and after caries removal in the three groups. The dentine samples were transferred to glass tubes containing a 1mL thioglycollate medium used as a carrier and enriched for microbiological detection of mutans streptococci and Lactobacillus spp, after incubation for 6h at room temperature. The minimum detection value for colony forming units (CFU) was 3.3 x 102 CFU/ml, and the results were converted into scores from 0 to 4. A significant difference was observed in relation to the microbiological scores before and after caries removal for all methods (Wilcoxon test; p chemomechanical methods for caries removal did not improve the reduction of cariogenic microorganisms in dentine caries lesions, in comparison with manual excavation.

  16. Self-assessed efficacy of a clinical musculoskeletal anatomy workshop: A preliminary survey.

    Science.gov (United States)

    Saavedra, Miguel Ángel; Navarro-Zarza, José E; Alvarez-Nemegyei, José; Canoso, Juan J; Kalish, Robert A; Villaseñor-Ovies, Pablo; Hernández-Díaz, Cristina

    2015-01-01

    To survey the efficacy of a practical workshop on clinical musculoskeletal anatomy held in five American countries. A self-assessment competence questionnaire sent to participants 1-3 months after the workshop. Results were compared to the results of a practical, instructor-assessed, pre-workshop test. The response rate of participants was 76.4%. The overall, self-assessed competence score for anatomical items that had been included in the pre-test was 76.9 (scale 0-100) as compared to an overall score of 48.1 in the practical, pre-workshop test (p<0.001). For items that were addressed in the workshop, but not included in the pre-test, self-assessed competence was rated at 62.9. Differences in anatomical knowledge between individuals from different countries and professional groups noted in the practical pre-test were no longer present in the post-test self-assessment. From this preliminary data and supporting evidence from the literature we believe that our anatomy workshop provides an effective didactic tool for increasing competence in musculoskeletal anatomy. Copyright © 2014 Elsevier España, S.L.U. All rights reserved.

  17. Efficacy of ozonized olive oil in the management of oral lesions and conditions: A clinical trial

    Directory of Open Access Journals (Sweden)

    Tarun Kumar

    2016-01-01

    Full Text Available The oral cavity is an open ecosystem that shows a dynamic balance between the entrance of microorganisms (bacterial, viral or fungal, colonization modalities, nutritional balance, and host defenses against their removal. The oral lesions including aphthous ulcerations, herpes labialis, oral candidiasis, oral lichen planus, and angular cheilitis some of the common entities encountered in the clinical practice. A variety of treatment options is available in the literature for all of these lesions and conditions. Topical ozone therapy is a minimally invasive technique that can be used for these conditions without any side effects. Aim and Objectives: To evaluate the efficacy of ozonized olive oil in the treatment of oral lesions and conditions. Materials and Methods: A longitudinal study was carried out on 50 patients (aphthous ulcerations, herpes labialis, oral candidiasis, oral lichen planus, and angular cheilitis. The ozonized olive oil was applied twice daily until the lesion regresses for a maximum of 6 months. Results: All the lesions regress in patients with aphthous ulcerations, herpes labialis, oral candidiasis and angular cheilitis or showed improvement in the signs and symptoms in oral lichen planus patients. No toxicity or side effect was observed in any of the patients. Conclusion: Ozone therapy though requires a gaseous form to be more effective, but topical form can also bring out the positive results without any toxicity or side effect. Hence, it can be considered as a minimally invasive therapy for the oral infective and immunological conditions.

  18. Intravenous immunoglobulin in neurology--mode of action and clinical efficacy.

    Science.gov (United States)

    Lünemann, Jan D; Nimmerjahn, Falk; Dalakas, Marinos C

    2015-02-01

    Intravenous immunoglobulin (IVIg)-a preparation of polyclonal serum IgG pooled from thousands of blood donors-has been used for nearly three decades, and is proving to be an efficient anti-inflammatory and immunomodulatory treatment for a growing number of neurological diseases. Evidence from controlled clinical trials has established IVIg as a first-line therapy for Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy and multifocal motor neuropathy. IVIg is also an effective rescue therapy in some patients with worsening myasthenia gravis, and is beneficial as a second-line therapy for dermatomyositis and stiff-person syndrome. IVIg has been tested in some neurodegenerative disorders, but a controlled study in Alzheimer disease yielded disappointing results. Despite its widespread use and therapeutic success, the mechanisms of action of IVIg are poorly understood. Several hypotheses, based on the function of either the variable or constant IgG fragments, have been proposed to explain IVIg's immunomodulatory activity. This Review highlights emerging data on the mechanisms of action of IVIg related to its anti-inflammatory activity, especially that involving the cellular Fcγ receptors and Fc glycosylation. We also summarize recent trials in neurological diseases, discuss potential biomarkers of efficacy, offer practical guidelines on administration, and provide a rationale for experimental trials in neuroinflammatory disorders.

  19. Pharmacokinetics and clinical efficacy of indomethacin in premature infants with patent ductus arteriosus.

    Science.gov (United States)

    Regazzi, M B; Rondanelli, R; Vidale, E; Chirico, G; Rondini, G; Chiara, A; Piccolo, A

    1984-01-01

    Despite a considerable amount of investigation, controversy continues concerning the use of indomethacin in inducing the closure of patent ductus arteriosus. This controversy may be attributable to differences in dosage, route of administration, postnatal age at treatment and the variable pharmacokinetics of the drug in premature infants. The pharmacokinetics and clinical efficacy of i.v. administered indomethacin in five premature infants with PDA were evaluated. There was considerable intersubject variability in the half life of elimination (63.1 +/- 38 h). This variability was mainly due to clearance (0.0086 +/- 0.0069 l/h/kg) rather than to distribution volume variability (0.54 +/- 0.27 l/kg). A reduction of half life was observed after the second dose, probably due to a maturation process. A permanent closure of the ductus was obtained in two patients after the first dose and in two patients after the second dose. The side-effects observed in our infants were transient and no long-term complication was attributable to this drug.

  20. Efficacy of ozonized olive oil in the management of oral lesions and conditions: A clinical trial

    Science.gov (United States)

    Kumar, Tarun; Arora, Neha; Puri, Gagan; Aravinda, Konidena; Dixit, Avani; Jatti, Deepa

    2016-01-01

    The oral cavity is an open ecosystem that shows a dynamic balance between the entrance of microorganisms (bacterial, viral or fungal), colonization modalities, nutritional balance, and host defenses against their removal. The oral lesions including aphthous ulcerations, herpes labialis, oral candidiasis, oral lichen planus, and angular cheilitis some of the common entities encountered in the clinical practice. A variety of treatment options is available in the literature for all of these lesions and conditions. Topical ozone therapy is a minimally invasive technique that can be used for these conditions without any side effects. Aim and Objectives: To evaluate the efficacy of ozonized olive oil in the treatment of oral lesions and conditions. Materials and Methods: A longitudinal study was carried out on 50 patients (aphthous ulcerations, herpes labialis, oral candidiasis, oral lichen planus, and angular cheilitis). The ozonized olive oil was applied twice daily until the lesion regresses for a maximum of 6 months. Results: All the lesions regress in patients with aphthous ulcerations, herpes labialis, oral candidiasis and angular cheilitis or showed improvement in the signs and symptoms in oral lichen planus patients. No toxicity or side effect was observed in any of the patients. Conclusion: Ozone therapy though requires a gaseous form to be more effective, but topical form can also bring out the positive results without any toxicity or side effect. Hence, it can be considered as a minimally invasive therapy for the oral infective and immunological conditions. PMID:27041901

  1. Clinical efficacy and drug resistance of anti-epidermalgrowth factor receptor therapy in colorectal cancer

    Institute of Scientific and Technical Information of China (English)

    2016-01-01

    Colorectal cancer (CRC) ranked third in cancer relateddeath and its incidence has been increasing worldwide.In recent decades important therapeutic advances havebeen developed in treatment of metastatic CRC (mCRC),such as monoclonal antibodies against epidermal growthfactor receptor (anti-EGFR), which provided additionalclinical benefits in mCRC. However, anti-EGFR therapieshave limited usage due to approximately 95% ofpatients with KRAS mutated mCRC do not response toanti-EGFR treatment. Thus, KRAS mutation is predictiveof nonresponse to anti-EGFR therapies but it alone is nota sufficient basis to decide who should not be receivedsuch therapies because; approximately fifty percent(40%-60%) of CRC patients with wild-type KRASmutation also have poor response to anti-EGFR basedtreatment. This fact leads us to suspect that there mustbe other molecular determinants of response to anti-EGFR therapies which have not been identified yet. Currentarticle summarizes the clinical efficacy of anti-EGFRtherapies and also evaluates its resistance mechanisms.

  2. Clinical and Microbiologic Efficacy of a Water Filter Program in a Rural Honduran Community

    Directory of Open Access Journals (Sweden)

    Jaclyn Arquiette

    2014-01-01

    Full Text Available Water purification in the rural Honduras is a focus of the nonprofit organization Honduras Outreach Medical Brigade Relief Effort (HOMBRE. We assessed water filter use and tested filter microbiologic and clinical efficacy. A 22-item questionnaire assessed water sources, obtainment/storage, purification, and incidence of gastrointestinal disease. Samples from home clay-based filters in La Hicaca were obtained and paired with surveys from the same home. We counted bacterial colonies of four bacterial classifications from each sample. Sixty-five surveys were completed. Forty-five (69% individuals used a filter. Fifteen respondents reported diarrhea in their home in the last 30 days; this incidence was higher in homes not using a filter. Thirty-three paired water samples and surveys were available. Twenty-eight samples (85% demonstrated bacterial growth. A control sample was obtained from the local river, the principal water source; number and bacterial colony types were innumerable within 24 hours. Access to clean water, the use of filters, and other treatment methods differed within a geographically proximal region. Although the majority of the water samples failed to achieve bacterial eradication, water filters may sufficiently reduce bacterial coliform counts to levels below infectious inoculation. Clay water filters may be sustainable water treatment measures in resource poor settings.

  3. [Clinical efficacy of mouse nerve growth factor in the treatment of sudden deafness].

    Science.gov (United States)

    Xu, Ting; Xiao, Dajiang; Wu, Sihai; Yuan, Yuan

    2014-05-01

    To study the clinical efficacy of mouse nerve growth factor (NGF) in the treatment of sudden deafness. A retrospective analysis was performed on 115 cases of hospitalized patients who were suffered from sudden deafness. Patients were divided into two groups according to treatment medicine. Control group: patients were treated with intravenous vasodilators, energy mixture, steroid pulse therapy, and methylcobalamin neurotrophic therapy. NGF group: intramuscular NGF treatment was added on the basis of conventional therapy mentioned above. Both treatments lasted 14 days, the total efficiency were compared. Patients were further divided into sub-groups according to age, duration and the level of pre-treatment PTA, and the treatment efficiency was further compared. By SPSS 11.0 statistical analysis, a P 60 dBHL, the efficiency of NGF therapy was not superior to the traditional treatment. NGF can significantly improve the symptom of patients with short duration or low PTA. For this kind of patients, NGF adjuvant therapy should be recommended. For the patients with longer duration and higher level of PTA, NGF therapy is not advocated. NGF treatment should not be in consideration of the age.

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

    Directory of Open Access Journals (Sweden)

    Michelle Mikhael AMMARI

    2014-08-01

    Full Text Available The aim of this study was to compare the efficacy of chemochemical methods (Carisolv™ and Papacárie® versus the manual method (excavators in reducing the cariogenic microbiota in dentine caries of primary teeth. Forty-six healthy children (5 to 9 years old having at least one primary tooth with a cavitated dentine carious lesion were included in the study. The teeth presented no clinical or radiographic signs of pulpal involvement. The sample of 74 teeth was randomly divided into three different groups: Papacárie® (n = 25, Carisolv™ (n = 27 and Manual (n = 22. Samples of carious and sound dentine were collected with sterile excavators before and after caries removal in the three groups. The dentine samples were transferred to glass tubes containing a 1mL thioglycollate medium used as a carrier and enriched for microbiological detection of mutans streptococci and Lactobacillus spp, after incubation for 6h at room temperature. The minimum detection value for colony forming units (CFU was 3.3 x 102 CFU/ml, and the results were converted into scores from 0 to 4. A significant difference was observed in relation to the microbiological scores before and after caries removal for all methods (Wilcoxon test; p < 0.001. The use of chemomechanical methods for caries removal did not improve the reduction of cariogenic microorganisms in dentine caries lesions, in comparison with manual excavation.

  5. Orthogonal NGS for High Throughput Clinical Diagnostics.

    Science.gov (United States)

    Chennagiri, Niru; White, Eric J; Frieden, Alexander; Lopez, Edgardo; Lieber, Daniel S; Nikiforov, Anastasia; Ross, Tristen; Batorsky, Rebecca; Hansen, Sherry; Lip, Va; Luquette, Lovelace J; Mauceli, Evan; Margulies, David; Milos, Patrice M; Napolitano, Nichole; Nizzari, Marcia M; Yu, Timothy; Thompson, John F

    2016-04-19

    Next generation sequencing is a transformative technology for discovering and diagnosing genetic disorders. However, high-throughput sequencing remains error-prone, necessitating variant confirmation in order to meet the exacting demands of clinical diagnostic sequencing. To address this, we devised an orthogonal, dual platform approach employing complementary target capture and sequencing chemistries to improve speed and accuracy of variant calls at a genomic scale. We combined DNA selection by bait-based hybridization followed by Illumina NextSeq reversible terminator sequencing with DNA selection by amplification followed by Ion Proton semiconductor sequencing. This approach yields genomic scale orthogonal confirmation of ~95% of exome variants. Overall variant sensitivity improves as each method covers thousands of coding exons missed by the other. We conclude that orthogonal NGS offers improvements in variant calling sensitivity when two platforms are used, better specificity for variants identified on both platforms, and greatly reduces the time and expense of Sanger follow-up, thus enabling physicians to act on genomic results more quickly.

  6. Association between self-efficacy, career interest and rural career intent in Australian medical students with rural clinical school experience

    Science.gov (United States)

    Isaac, Vivian; Walters, Lucie; McLachlan, Craig S

    2015-01-01

    Objectives To investigate medical student's self-efficacy at the time of finishing their rural clinical school (RCS) placement and factors associated with self-efficacy. Secondary aims are to explore whether interest levels or self-efficacy are associated with rural or remote career intentions. Design, setting and participants A cross-sectional study of medical students who had completed their RCS term in 17 Australian universities. Data were derived from the 2013 Federation of Rural Australian Medical Educators (FRAME) evaluation survey. Questionnaire responses were analysed from 653 medical students from regional Australia. All 732 students who completed their RCS term in 2013 were invited to participate. Primary and secondary outcome measures Rural self-efficacy: Six questions to measure self-efficacy beliefs in rural medical practice, based on the sources of self-efficacy described by Bandura. Rural career intention: Students were asked to identify their preferred location for future practice. The options were, Capital or Major City; Inner regional city or large town; Smaller town and very remote area. Results Questionnaire responses were analysed from 653 medical students from regional Australia (response rate 89.2%). 83.8% of all students recalled an increase in their interest levels for rural medicine as a result of their RCS experience. Actual career intention to work in a regional area or rural area was 60.2%. Bivariate analyses showed female gender (p=0.003), rural background (prural medicine (OR 1.4 (95% CI 1.3 to 1.5)) and rural career intent (OR 1.2 (95% CI 1.1 to 1.3)). (Model included gender, rural background, preference for RCS, generalist intent, rural practice interest and self-efficacy). Conclusions Self-efficacy is associated with increased interest levels for rural medicine and rural medical career intent. PMID:26671960

  7. EFFICACY OF JOSHANDA ZEEQUNNAFAS AND HABBE HINDI ZEEQI IN ZEEQUNNAFAS (BRONCHIAL ASTHMA - AN OBSERVATIONAL OPEN CLINICAL TRIAL

    Directory of Open Access Journals (Sweden)

    Juned Ahmad

    2014-12-01

    Full Text Available Background: Bronchial asthma is a major public health concern, affecting 100-150 million people worldwide and accounts for an estimated 1,80,000 deaths per year. Its incidence is swiftly escalating in India. Unani medicine is augment with many single and compound drugs, which own potential effects to cure the disease, but these formulations are not proof scientifically. Objective: To evaluate the efficacy of Joshanda Zeequnnafas and Habbe Hindi Zeeqi in the treatment of Zeequnnafas to provide safe and effective treatment for asthma. Methods: The clinical trial to assess the efficacy of Joshanda Zeequnnafas and Habbe Hindi Zeeqi in the management of asthma. 50 patients were screened and out of them 30 patients were selected for study. Joshanda Zeequnnafas and Habbe Hindi Zeeqi were administered orally 50 ml (as decoction twice a day and 125 mg (as tablet form twice a day for 45 days. Subjective and objective parameters follow up before and after treatment on 0, 15th, 30th, and 45th day of the treatment. In subjective parameter, paroxysmal dyspnoea and wheeze was analysed using paired proportion test. Objective parameter was assessed by the help of Spirometry in terms of ESR, Eosinophilia, FEV1, FEV1/FVC% and PEF and student paired t test was applied to get the results. Safety parameters included complete blood count, SGOT, SGPT, Blood urea, S. Creatinine, RBS, and Urine routine and microscopic; and were assessed on student paired t test. Results: The overall result was highly significant in terms of subjective and objective parameters specially FEV1and PEF (P0.178, 0.785, and 0.220 respectively. Conclusion: The study results suggest that the trials formulations are quite effective in the management of Zeequnnafas. No adverse effects were noted during the complete course of the study trial. Hence it infers that trial drugs are safe, and effective in the treatment of Zeequnnafas (bronchial asthma.

  8. The study of perceived stress, coping strategy and self-efficacy of Chinese undergraduate nursing students in clinical practice.

    Science.gov (United States)

    Zhao, Fang-Fang; Lei, Xiao-Ling; He, Wei; Gu, Yan-Hong; Li, Dong-Wen

    2015-08-01

    The aim of the study was to explore the coping strategy and the effects of self-efficacy of Chinese undergraduate nursing students when they face the stress in clinical practice. Convenience sampling was used to recruit undergraduate nursing students in Mainland China who have practiced 3 months in hospitals in their final college year. Self-report questionnaires including demographics, Perceived Stress Scale, coping behaviour inventory and Generalized Self-Efficacy Scale were collected. The results showed that during clinical practice, assignments and workload were the most common stress to students; transference was the most frequently used coping strategy by students. Self-efficacy not only had a positive main effect in predicting the frequency of use of staying optimistic and problem solving strategies but also moderated the effects of stress from taking care of patients on transference strategy, as well as stress from assignments and workload on problem solving strategy. It is essential to bolster the students' self-efficacy to reduce stress and adopt positively the coping strategies during clinical practice.

  9. Development and validation of a self-efficacy questionnaire (SE-12) measuring the clinical communication skills of health care professionals

    DEFF Research Database (Denmark)

    Axboe, Mette K; Christensen, Kaj S; Kofoed, Poul-Erik

    2016-01-01

    . We consider the questionnaire useful for self-evaluation of clinical communication skills; the SE-12 is user-friendly and can be administered as an electronic questionnaire. However, future research should explore potential needs for adjustments to reduce the identified ceiling effect. Keyword...... Communication skills training Self-efficacy Self-assessment Calgary-Cambridge Guide Questionnaire Validity Reliability......Background The outcome of communication training is widely measured by self-efficacy ratings, and different questionnaires have been used. Nevertheless, none of these questionnaires have been formally validated through systematic measurement of assessment properties. Consequently, we decided...

  10. Clinical efficacy and safety in relapsed/refractory diffuse large B-cell lymphoma: a systematic literature review.

    Science.gov (United States)

    Colosia, Ann; Njue, Annete; Trask, Peter C; Olivares, Robert; Khan, Shahnaz; Abbe, Adeline; Police, Rachel; Wang, Jianmin; Ruiz-Soto, Rodrigo; Kaye, James A; Awan, Farrukh

    2014-10-01

    This systematic literature review was designed to assess information on the clinical efficacy and safety of interventions used in the treatment of refractory or relapsed diffuse large B-cell lymphoma (R/R DLBCL) and to perform a meta-analysis if possible. We searched databases (PubMed, EMBASE, and Cochrane Library for articles from 1997 to August 2, 2012 reported in English), conference abstracts, bibliographic reference lists, and the ClinicalTrials.gov database for phase II to IV studies with results. Studies had to report on patients with R/R DLBCL who were not eligible to receive high-dose therapy (HDT) with stem cell transplantation (SCT) (autologous or allogeneic). Mixed-type non-Hodgkin lymphoma (NHL) studies were required to report R/R DLBCL outcomes separately. We identified 55 studies that presented outcomes data separately for patients with R/R DLBCL. Of 7 comparative studies, only 4 were randomized controlled trials (RCTs). In the 2 RCTs with a common regimen, the patient populations differed too greatly to perform a valid meta-analysis. The 48 single-arm studies identified were typically small (n < 50 in most), with 31% reporting median progression-free survival (PFS) or overall survival (OS) specifically for the R/R DLBCL population. In these studies, median OS ranged from 4 to 13 months. The small number of RCTs in R/R DLBCL precludes identifying optimal treatments. Small sample size, infrequent reporting of OS and PFS separated by histologic type, and limited information on patient characteristics also hinder comparison of results. Randomized studies are needed to demonstrate which current therapies have advantages for improving survival and other important clinical outcomes in patients with R/R DLBCL.

  11. Goals and intentions mediate efficacy beliefs and declining physical activity in high school girls.

    Science.gov (United States)

    Dishman, Rod K; Saunders, Ruth P; Felton, Gwen; Ward, Dianne S; Dowda, Marsha; Pate, Russ R

    2006-12-01

    According to theory, girls who set goals about increasing their physical activity and who are dissatisfied with their current activity level are likely to form intentions to be active and to carry out those intentions, especially if they have high efficacy and control beliefs about being physically active. We tested those ideas while observing naturally occurring change during high school. A cohort of 431 black and white girls was tested at the end of their 9th- and 12th-grade academic years. Confirmatory factor analysis established the structural invariance of the measures across the 3-year study period. Structural equation modeling and panel analysis were used to determine whether changes in goal setting and satisfaction would mediate relations of self-efficacy and perceived behavioral control with changes in intention and physical activity. Testing occurred between February and May in 1999 and 2004. Data were analyzed in 2006. Goal setting and intention mediated the indirect relation between self-efficacy and change in physical activity. Perceived behavioral control and physical activity change were related directly and also indirectly by a path mediated through satisfaction and intention. Black girls had lower self-efficacy, but changes in other variables were unrelated to race. These observations of longitudinal relations elaborate application of self-efficacy theory and the theory of planned behavior to physical activity by showing that goal setting and satisfaction mediate the relations of self-efficacy and perceived behavioral control with changes in intention and physical activity. The results encourage additional research to identify the sources and development of physical activity goals, and their attainment, among girls, and whether experimental manipulation of goals and intentions can mitigate the decline in girls' physical activity during high school.

  12. The Efficacy of a Three-Week Stress Management Unit for High School Students.

    Science.gov (United States)

    Richardson, Glenn E.; And Others

    1983-01-01

    A study used psychometric information to determine the efficacy of a stress management unit in a high school health class. Students who took the unit showed improvement in knowledge, attitudes, and the ability to relax, as demonstrated on tests of heart rate and muscular tension. (PP)

  13. Personality Traits' Effects on Self-Efficacy and Outcome Expectations for High School Major Choice

    Science.gov (United States)

    Brown, Dikla; Cinamon, Rachel Gali

    2016-01-01

    The current study focuses on the contribution of the Big Five personality traits to the development of self-efficacy and outcome expectations regarding selection of a high school major among 368 Israeli adolescents (Mage = 16.07, SD = 0.41). Structural equation analyses showed that higher levels of conscientiousness and extraversion and lower…

  14. Modeling the Relationship between High School Students' Chemistry Self-Efficacy and Metacognitive Awareness

    Science.gov (United States)

    Kirbulut, Zubeyde Demet

    2014-01-01

    In this study, the relationship between students' chemistry self-efficacy beliefs and metacognitive awareness was investigated utilizing a path model. There were 268 chemistry high school students (59% 10th grade and 41% 11th grade) participated in the study. The students took two-hour chemistry course in the 9th and 10th grade and three-hour…

  15. Cancer stem cell-driven efficacy of trastuzumab (Herceptin): towards a reclassification of clinically HER2-positive breast carcinomas.

    Science.gov (United States)

    Martin-Castillo, Begoña; Lopez-Bonet, Eugeni; Cuyàs, Elisabet; Viñas, Gemma; Pernas, Sonia; Dorca, Joan; Menendez, Javier A

    2015-10-20

    Clinically HER2+ (cHER2+) breast cancer (BC) can no longer be considered a single BC disease entity in terms of trastuzumab responsiveness. Here we propose a framework for predicting the response of cHER2+ to trastuzumab that integrates the molecular distinctions of intrinsic BC subtypes with recent knowledge on cancer stem cell (CSC) biology. First, we consider that two interchangeable populations of epithelial-like, aldehyde dehydrogenase (ALDH)-expressing and mesenchymal-like, CD44+CD24-/low CSCs can be found in significantly different proportions across all intrinsic BC subtypes. Second, we overlap all the intrinsic subtypes across cHER2+ BC to obtain a continuum of mixed phenotypes in which one extreme exhibits a high identity with ALDH+ CSCs and the other extreme exhibits a high preponderance of CD44+CD24-/low CSCs. The differential enrichment of trastuzumab-responsive ALDH+ CSCs versus trastuzumab-refractory CD44+CD24-/low CSCs can explain both the clinical behavior and the primary efficacy of trastuzumab in each molecular subtype of cHER2+ (i.e., HER2-enriched/cHER2+, luminal A/cHER2+, luminal B/cHER2+, basal/cHER2+, and claudin-low/cHER2+). The intrinsic plasticity determining the epigenetic ability of cHER2+ tumors to switch between epithelial and mesenchymal CSC states will vary across the continuum of mixed phenotypes, thus dictating their intratumoral heterogeneity and, hence, their evolutionary response to trastuzumab. Because CD44+CD24-/low mesenchymal-like CSCs distinctively possess a highly endocytic activity, the otherwise irrelevant HER2 can open the door to a type of "Trojan horse" approach by employing antibody-drug conjugates such as T-DM1, which will allow a rapid and CSC-targeted delivery of cytotoxic drugs to therapeutically manage trastuzumab-unresponsive basal/cHER2+ BC. Contrary to the current dichotomous model used clinically, our model proposes that a reclassification of cHER2+ tumors based on the spectrum of molecular BC subtypes

  16. Efficacy of a Maternal Depression Prevention Strategy in Head Start: A Randomized Clinical Trial.

    Science.gov (United States)

    Silverstein, Michael; Diaz-Linhart, Yaminette; Cabral, Howard; Beardslee, William; Hegel, Mark; Haile, Winta; Sander, Jenna; Patts, Gregory; Feinberg, Emily

    2017-08-01

    Low-income and minority mothers experience a disproportionate incidence of depression and lack access to treatment services. Development of prevention strategies in accessible community-based venues is a potentially important public health strategy. To determine the efficacy of a depression prevention strategy embedded in Head Start. This randomized clinical trial was performed from February 15, 2011, through May 9, 2016, at 6 Head Start agencies serving families at or below the federal poverty level. Participants included mothers with depressed mood, anhedonia, or depression history but who were not in a current major depressive episode. Participants were followed up for 12 months with masked outcome assessments. Final follow-up was completed on May 9, 2016. Participants were randomized to a problem-solving education (PSE) intervention (n = 111) or usual Head Start services (n = 119). Primary outcomes were problem-solving skills and depressive symptoms. To capture the chronicity and intensity of symptoms, the Quick Inventory of Depressive Symptoms was administered bimonthly, and rates of clinically significant symptom elevations were compared across groups. Secondarily, the presence of a major depressive episode was assessed using the Structured Clinical Interview for DSM-IV Axis I Disorders. Among the 230 participants, 152 (66.1%) were Hispanic, with a mean (SD) age of 31.4 (7.3) years. An intention-to-treat analysis among 223 participants contributing follow-up data found no differences in problem-solving skills across groups. The mean (SD) number of depressive symptom elevations among the PSE participants was 0.84 (1.39) compared with 1.12 (1.47) among the usual service participants (adjusted incident rate ratio [aIRR], 0.60; 95% CI, 0.41-0.90). In analyses stratified according to baseline depressive symptoms, PSE exerted a preventive effect among those with lower-level baseline symptoms, with a mean (SD) of 0.39 (0.84) elevations among PSE participants

  17. Clinical and Laboratory Evaluation of Anti-Microbial Efficacy of Photocatalysts

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    Serdar Günaydın

    2011-05-01

    Full Text Available Aim: This study aims at investigating and testing the tentative antimicrobial efficacy; in vitro and in- hospital applications of apatite coated ferrum titanate which is one of the new generation photocatalysts. Material and Methods: 30 sterile petri dishes were kept under florescent light for 4 days following the application of 20 ppm apatite coated ferrum titanate aerosol. 0.5 McFarland (1.5X108 CFU/mL -CFU=colony forming unit Pseudomonas aeruginosa and 0.5 McFarland Acinetobacter baumannii were cultured on 10 separate dishes. 10 unprocessed dishes were used as controls. Samples were evaluated for bacterial survival rate (CFUX100/CFU after application. In the second step, same photocatalyst aerosol was applied as 0.012 L/m2 with the specific kit on the surfaces of different units within the hospital. Particle count was measured and  compared before and one-month after the photocatalyst application by lumimeter. Results: Bacterial survival rate was significantly lower on photocatalyst applied surfaces versus control for Pseudomonas aeruginosa after second day of application (p<0.001 (60±8% / 95±9%. This difference continued up to the 4th day gradually (3. day: 35±5% / 90±9%; 4. day:22±5% / 85±8%. Bacterial survival rate was significantly lower on photocatalyst applied surfaces versus control for Acinetobacter baumannii after the second day of application (55±7% / 87±8% (p<0.01. This difference continued up to the 4th day gradually (3. day:40±5% / 80±8%; 4. day:15±5% / 78±7%. Particle count on photocatalyst applied surfaces diminished 97.15% in operating room, 95.61% in ICU, 98.30 in physicians’ room, 94.13% in wards and 97.04% in hospital kitchen. Conclusions: As a result of our pioneering study on the evaluation of photocatalyst, we think that it may be one of the economic and safe alternative methods of hospital sterilization based on bactericidal and bacteriostatic efficacy confirmed in both laboratory and clinical

  18. Clinical efficacy of high-dose induction therapy by maintenance with recombinant human erythropoietin (rhEPO) in intestinal fistula patients complicated with intra-abdominal infection with anemia%rhEPO大剂量冲击维持疗法治疗肠瘘合并腹腔感染病人贫血的临床研究

    Institute of Scientific and Technical Information of China (English)

    洪之武; 任建安; 刘颂; 顾国胜; 袁玉杰; 周波; 闫冬升; 黎介寿

    2012-01-01

    目的 探讨重组人红细胞生成素(recombinant human erythropoietin,rhEPO)大剂量冲击维持疗法治疗肠瘘合并腹腔感染病人贫血的临床价值.方法 选择2010年9月至2011年12月南京军区南京总医院肠瘘治疗病区114例肠瘘致腹腔感染伴贫血且资料完整的病例,按照机体含铁量情况分为机体铁含量正常组和机体铁缺乏组,同时铁含量正常组再次随机分为单纯营养支持治疗(enteral nutrition/parenteral nutrition,EN/PN)组和EN/PN联合大剂量rhEPO冲击维持治疗组(各30例);铁缺乏组分为EN/PN联合铁剂(iron)组和EN/PN联合iron、大剂量rhEPO冲击维持治疗组(各27例).入组病例全部给予足量EN/PN、rhEPO和(或)蔗糖铁注射剂治疗并进行疗效观察.结果 两组病人治疗前后血红蛋白(Hb)比较,治疗前Hb差异无统计学意义(P>0.05).体内含铁量正常病人,在rhEPO治疗组2周后Hb明显高于未实施rhEPO干预组(P<0.05);体内含铁缺乏病人,铁剂联合rhEPO治疗组2周后Hb明显高于未实施rhEPO治疗组(P<0.05).大多数病人耐受良好.结论 肠瘘致腹腔感染伴贫血病人给予皮下注射rhEPO大剂量冲击维持疗法可有效快速提高病人的红细胞(RBC)及Hb水平,改善病人的贫血状况.该疗法耐受性较好,值得进一步扩大临床研究.%Objective To study clinical efficacy of recombinant human erythropoietin (rhEPO) in intestinal fistula patients complicated with intra-abdominal infection with anemia. Methods One hundred and fourteen patients with intestinal fistula complicated with intra-abdominal infection with anemia admitted from September 2010 to December 2011 in General Hospital of Nanjing Military Command were enrolled. In accordance with the iron content of the body the patients were divided into the group with the normal iron content in the body and the group with the deficient iron content. The normal iron content group was randomly divided into nutrition support

  19. Efficacy of ethanol-based hand foams using clinically relevant amounts: a cross-over controlled study among healthy volunteers.

    Science.gov (United States)

    Kampf, Günter; Marschall, Sigunde; Eggerstedt, Sven; Ostermeyer, Christiane

    2010-03-26

    Foams containing 62% ethanol are used for hand decontamination in many countries. A long drying time may reduce the compliance of healthcare workers in applying the recommended amount of foam. Therefore, we have investigated the correlation between the applied amount and drying time, and the bactericidal efficacy of ethanol foams. In a first part of tests, four foams (Alcare plus, Avagard Foam, Bode test foam, Purell Instant Hand Sanitizer) containing 62% ethanol, which is commonly used in U.S. hospitals, were applied to 14 volunteers in a total of seven variations, to measure drying times. In a second part of tests, the efficacy of the established amount of foam for a 30 s application time of two foams (Alcare plus, Purell Instant Hand Sanitizer) and water was compared to the EN 1500 standard of 2 x 3 mL applications of 2-propanol 60% (v/v), on hands artificially contaminated with Escherichia coli. Each application used a cross-over design against the reference alcohol with 15 volunteers. The mean weight of the applied foam varied between 1.78 and 3.09 g, and the mean duration to dryness was between 37 s and 103 s. The correlation between the amount of foam applied and time until hands felt dry was highly significant (p < 0.001; Pearson's correlation coefficient: 0.724; 95% confidence interval: 0.52-0.93). By linear correlation, 1.6 g gave an intercept of a 30 s application time. Application of 1.6 g of Purell Instant Hand Sanitizer (mean log10-reduction: 3.05 +/- 0.45) and Alcare plus (3.58 +/- 0.71) was significantly less effective than the reference disinfection (4.83 +/- 0.89 and 4.60 +/- 0.59, respectively; p < 0.001). Application of 1.6 g of water gave a mean log10-reduction of 2.39 +/- 0.57. When using 62% ethanol foams, the time required for dryness often exceeds the recommended 30 s. Therefore, only a small volume is likely to be applied in clinical practice. Small amounts, however, failed to meet the efficacy requirements of EN 1500 and were only

  20. Efficacy of beta-carotene topical application in melasma - An open clinical trial

    Directory of Open Access Journals (Sweden)

    Kar H

    2003-03-01

    Full Text Available Beta-carotene, a structural analogue of vitamin A, works as an agonist of this vitamin, by reversibly sticking the chemical mechanism of melanogenesis by saturating the nuclear receptors of melanocytes and /or binding protein. To study the safety and efficacy of Beta-carotene lotion on topical application in melasma, clinically diagnosed 31 adults (26Fand 5M with melasma were included in this trial. All of them applied Beta-carotene lotion daily, morning and evening to the affected areas. Twenty six of them, completed regular 8 weeks treatment. Nine of them continued same treatment for 16 more weeks. All cases were evaluated clinically using melasma intensity (MPI index (Grade I, II, III and size of the lesion. Clinical photograph was taken for each case at 0 week, 8th week and 24th week. Initial 8 weeks treatment revealed that the single case with grade-I pigmentation included in this study recovered completely. Two out of 13 cases with grade-II pigmentation, showed no change, in 10 cases, pigmentation became lighter to grade-I (76.9% and one case recovered completely. Out of 12 grade-III cases, one did not show any change, 10(83.3% converted to grade-II and one to grade-I. At the end of 24 weeks, all the nine cases (2 grade-II and 7 grade-III showed further clearing of the pigmentation to the next lower grade. Side effects like mild erythemo and local irritation were observed in two cases each, who were advised to discontinue treatment as per the protocol. In control group, out of 12 (two with grade -II, six in grade - II, and four in grade-III cases 11 showed no improvement, only one case with grade-II melasma revealed reduction of pigmentation to grade-I. One case developed local irritation. In conclusion, topical application of Beta-carotene lotion appears to be an effective and safe for melasma. Longer duration of application is associated with better result.

  1. High luminous efficacy green light-emitting diodes with AlGaN cap layer.

    Science.gov (United States)

    Alhassan, Abdullah I; Farrell, Robert M; Saifaddin, Burhan; Mughal, Asad; Wu, Feng; DenBaars, Steven P; Nakamura, Shuji; Speck, James S

    2016-08-01

    We demonstrate very high luminous efficacy green light-emitting diodes employing Al0.30Ga0.70N cap layer grown on patterned sapphire substrates by metal organic chemical vapor deposition. The peak external quantum efficiency and luminous efficacies were 44.3% and 239 lm/w, respectively. At 20 mA (20 A/cm2) the light output power was 14.3 mW, the forward voltage was 3.5 V, the emission wavelength was 526.6 nm, and the external quantum efficiency was 30.2%. These results are among the highest reported luminous efficacy values for InGaN based green light-emitting diodes.

  2. Collective efficacy in a high-fidelity simulation of an airline operations center

    Science.gov (United States)

    Jinkerson, Shanna

    This study investigated the relationships between collective efficacy, teamwork, and team performance. Participants were placed into teams, where they worked together in a high-fidelity simulation of an airline operations center. Each individual was assigned a different role to represent different jobs within an airline (Flight Operations Coordinator, Crew Scheduling, Maintenance, Weather, Flight Scheduling, or Flight Planning.) Participants completed a total of three simulations with an After Action Review between each. Within this setting, both team performance and teamwork behaviors were shown to be positively related to expectations for subsequent performance (collective efficacy). Additionally, teamwork and collective efficacy were not shown to be concomitantly related to subsequent team performance. A chi-square test was used to evaluate existence of performance spirals, and they were not supported. The results of this study were likely impacted by lack of power, as well as a lack of consistency across the three simulations.

  3. Efficacy of intravenous ketamine for treatment of chronic posttraumatic stress disorder : A randomized clinical trial

    NARCIS (Netherlands)

    Feder, Adriana; Parides, Michael K.; Murrough, James W.; Perez, Andrew M.; Morgan, Julia E.; Saxena, Shireen; Kirkwood, Katherine; Aan Het Rot, Marije; Lapidus, Kyle A.B.; Wan, Le-Ben; Iosifescu, Dan; Charney, Dennis S.

    2014-01-01

    IMPORTANCE Few pharmacotherapies have demonstrated sufficient efficacy in the treatment of posttraumatic stress disorder (PTSD), a chronic and disabling condition. OBJECTIVE To test the efficacy and safety of a single intravenous subanesthetic dose of ketamine for the treatment of PTSD and associate

  4. Predicting In Vivo Anti-Hepatofibrotic Drug Efficacy Based on In Vitro High-Content Analysis

    Science.gov (United States)

    Zheng, Baixue; Tan, Looling; Mo, Xuejun; Yu, Weimiao; Wang, Yan; Tucker-Kellogg, Lisa; Welsch, Roy E.; So, Peter T. C.; Yu, Hanry

    2011-01-01

    Background/Aims Many anti-fibrotic drugs with high in vitro efficacies fail to produce significant effects in vivo. The aim of this work is to use a statistical approach to design a numerical predictor that correlates better with in vivo outcomes. Methods High-content analysis (HCA) was performed with 49 drugs on hepatic stellate cells (HSCs) LX-2 stained with 10 fibrotic markers. ∼0.3 billion feature values from all cells in >150,000 images were quantified to reflect the drug effects. A systematic literature search on the in vivo effects of all 49 drugs on hepatofibrotic rats yields 28 papers with histological scores. The in vivo and in vitro datasets were used to compute a single efficacy predictor (Epredict). Results We used in vivo data from one context (CCl4 rats with drug treatments) to optimize the computation of Epredict. This optimized relationship was independently validated using in vivo data from two different contexts (treatment of DMN rats and prevention of CCl4 induction). A linear in vitro-in vivo correlation was consistently observed in all the three contexts. We used Epredict values to cluster drugs according to efficacy; and found that high-efficacy drugs tended to target proliferation, apoptosis and contractility of HSCs. Conclusions The Epredict statistic, based on a prioritized combination of in vitro features, provides a better correlation between in vitro and in vivo drug response than any of the traditional in vitro markers considered. PMID:22073152

  5. Clinical and immunological efficacy of combination therapy of children with measles

    Directory of Open Access Journals (Sweden)

    V. N. Timchenko

    2016-01-01

    Full Text Available The aim of the study was to assess the clinical and immunological efficacy of recombinant interferon Alfa-2b. Examined 34 children aged from 1 year to 7 years carrying medium to heavy degree of measles. All patients were not vaccinated against measles. In the treatment of 18 people (Control group were used only basic therapy (pathogenic, symptomatic. At 16 people (Study group used a combination therapy (basic + Viferon. As an antiviral agent used and immunotropic preparation of human recombinant interferon alfa-2b in the form of rectal suppositories – Viferon (OOO «Feron», Russia. Immunological patient survey was conducted in the dynamics of the disease – during the height (in 1-6 days the rash and in convalescence period (10-16 days rash. Indicators of cellular immunity (leukocytes, lymphocytes, CD3 +, CD3 + CD (16 + 56 +, CD3 + CD4 +, CD3 + CD8 +, CD4 + CD8 +, CD3-CD8 +, CD3-CD (16 + 56, CD19 +, CD25 +, CD3 + HLA DR +, CD (16 + 56 + HLA DR +, HLA DR +, CD95 + were evaluated by flow cytometry. To assess the production of IFN-α and IFN-γ in the samples of peripheral blood were cultured in the CO2 incubator for 18 hours at 37 C and 4% CO2. The supernatants of cell culture were investigated with the purpose of studying spontaneous and induced production of interferon alpha and gamma. The concentrations of interferon α and γ (IFNα, IFNγ in the blood serum, as well as levels of spontaneous and induced cytokine production data of blood cells of sick children was determined by ELISA. All the children at the peak of the disease found a dramatic inhibition of cellular immunity and the production of cytokines, which is consistent with the concept of «measles anergy» accepted in the scientific literature. The period of convalescence oppression immunity indices remained, but it was less pronounced in the group of children treated with the drug of human recombinant interferon alfa-2b -Viferon. Clinical efficacy

  6. Dose titration of the clinical efficacy of intravenously administered flunixin meglumine in a reversible model of equine foot lameness.

    Science.gov (United States)

    Foreman, J H; Bergstrom, B E; Golden, K S; Roark, J J; Coren, D S; Foreman, C R; Schumacher, S A

    2012-12-01

    There are no refereed controlled documentations of the skeletal analgesic efficacy of different dosages of flunixin meglumine (FM). The objective of this experiment was to compare the efficacy of various dosages of FM with a negative control. The hypothesis was that higher doses would result in improved efficacy in a dose-dependent manner when tested in a reversible model of foot lameness. Ten horses shod with adjustable heart bar shoes had weekly modified AAEP grade 4.0/5.0 lameness induced by tightening a set screw against the heart bar. Heart rate (HR) and lameness score (LS) were monitored by one double-blinded investigator at rest; every 20 min after lameness induction for 5 h and hourly for another 8 h. One hour after lameness induction, treatments were administered i.v. in a randomised order: negative control (isotonic saline: SAL) or FM at 0.55 (half-dose), 1.1 (single-dose) or 2.2 (double-dose) mg/kg bwt. Results were compared using RM ANOVA and Student-Newman-Keul's test with the level of significance set at P Flunixin meglumine administration affected dependent variables in a dose-dependent manner with half-dose FM clinically effective for a shorter period. Higher dosages did not perform differently from one another. Practitioners must be aware that half-doses of FM are less efficacious than single doses but double doses are not more efficacious and yet are potentially more toxic.

  7. Efficacy and safety of N-acetylcysteine in prevention of noise induced hearing loss: a randomized clinical trial.

    Science.gov (United States)

    Kopke, Richard; Slade, Martin D; Jackson, Ronald; Hammill, Tanisha; Fausti, Stephen; Lonsbury-Martin, Brenda; Sanderson, Alicia; Dreisbach, Laura; Rabinowitz, Peter; Torre, Peter; Balough, Ben

    2015-05-01

    Despite a robust hearing conservation program, military personnel continue to be at high risk for noise induced hearing loss (NIHL). For more than a decade, a number of laboratories have investigated the use of antioxidants as a safe and effective adjunct to hearing conservation programs. Of the antioxidants that have been investigated, N-acetylcysteine (NAC) has consistently reduced permanent NIHL in the laboratory, but its clinical efficacy is still controversial. This study provides a prospective, randomized, double-blinded, placebo-controlled clinical trial investigating the safety profile and the efficacy of NAC to prevent hearing loss in a military population after weapons training. Of the 566 total study subjects, 277 received NAC while 289 were given placebo. The null hypothesis for the rate of STS was not rejected based on the measured results. While no significant differences were found for the primary outcome, rate of threshold shifts, the right ear threshold shift rate difference did approach significance (p = 0.0562). No significant difference was found in the second primary outcome, percentage of subjects experiencing an adverse event between placebo and NAC groups (26.7% and 27.4%, respectively, p = 0.4465). Results for the secondary outcome, STS rate in the trigger hand ear, did show a significant difference (34.98% for placebo-treated, 27.14% for NAC-treated, p-value = 0.0288). Additionally, post-hoc analysis showed significant differences in threshold shift rates when handedness was taken into account. While the secondary outcomes and post-hoc analysis suggest that NAC treatment is superior to the placebo, the present study design failed to confirm this. The lack of significant differences in overall hearing loss between the treatment and placebo groups may be due to a number of factors, including suboptimal dosing, premature post-exposure audiograms, or differences in risk between ears or subjects. Based on secondary outcomes and post hoc

  8. CLINICAL EFFICACY OF GLYCOSAMINOGLYCANS IN PATIENTS WITH DIABETES MELLITUS AND ISCHEMIC HEART DISEASE

    Directory of Open Access Journals (Sweden)

    L. V. Kozlova

    2011-01-01

    Full Text Available Aim. To study sulodexide clinical efficacy in patients with type 2 diabetes mellitus (DM and ischemic heart disease (IHD in prevention of contrast induced nephropathy (CIN. Material and мethods. Patients with type 2 DM and IHD who undergone X-Ray contrast intervention. The patients were randomized into 2 groups: 56 patients of the main group were i/v administered sulodexide (Vessel Due F , “Alfa Wassermann”, Italy according to standard procedure; 56 patients of the control group were treated with unfractionated heparin. Results. The incidence of CIN in the main and control groups was, respectively , 16% and 42% (p<0.01. Reduction of microalbuminuria (MAU was found in 89.3% of the sulodexide group patients. MAU dynamics in patients of control group was not observed. There were no deteriorations in echocardiography characteristics in patients of both groups. The reduction in  low density cholesterol and triglyceride plasma levels was observed in the main group. Sulodexide induced a lengthening of the activated partial thromboplastin time (from 30±0.6 to 34±0.5 s, without altering fibrinogen level. There were no thrombotic and hemorrhagic complications of endovascular intervention in sulodexide group. No one case of thrombocytopenia was observed. Higher risk of CIN in patients without sulodexide treatment compared with this in sulodexide treated patients was associated with multiple lesions of coronary arteries, diuretic intake in periprocedural period, contrast agent dose, duration of hospitalization, seriousness of intervention. Conclusion. Sulodexide therapy in patients with 2 type DM and IHD undergone X-Ray contrast intervention prevents renal dysfunction, providing antiproteinuric effect and correcting lipid metabolism and coagulation system disturbances.

  9. Safety and efficacy of iron sucrose in patients sensitive to iron dextran: North American clinical trial.

    Science.gov (United States)

    Van Wyck, D B; Cavallo, G; Spinowitz, B S; Adhikarla, R; Gagnon, S; Charytan, C; Levin, N

    2000-07-01

    Sensitivity to iron dextran is a potent obstacle to maintaining optimum iron status in patients with dialysis-associated anemia. As part of the North American clinical trials for iron sucrose injection, we examined the effect of intravenous (IV) iron sucrose in 23 hemodialysis patients with documented sensitivity to iron dextran, ongoing epoetin alfa therapy, and below-target-range hemoglobin (Hgb) levels (iron dextran were judged to be mild (n = 16; group A) or severe (n = 7; group B). We prospectively examined adverse events and vital signs after administering 100 mg of IV iron sucrose in each of 10 consecutive dialysis treatment sessions and compared results with those recorded in each of three consecutive dialysis sessions without iron treatment. We administered iron sucrose by IV push over 5 minutes to group A patients and by IV push over 5 minutes or IV infusion over 15 to 30 minutes to group B patients. We did not administer a test dose. Results showed no serious adverse drug reactions after a total of 223 doses of iron sucrose (184 doses by IV push, 39 doses by IV infusion). Intradialytic blood pressure changes after IV iron sucrose injection did not differ from those recorded during dialysis sessions without treatment. An increase in values for Hgb, hematocrit, transferrin saturation, and ferritin, coupled with no significant change in epoetin dose and a decrease in total iron-binding capacity, confirmed the efficacy of iron sucrose injection in managing anemia. We conclude that iron sucrose injection is safe and effective in the management of anemia in patients sensitive to iron dextran and can be administered without a test dose by IV push or infusion.

  10. Cost-efficacy analysis of darunavir/r monotherapy in clinical practice

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    M Pérez Elías

    2012-11-01

    Full Text Available Purpose of the study: To evaluate the economic impact of a swiching strategy to DRV/r mx in clinical practice using Spanish prices. Methods: Multicenter retrospective study of four tertiary hospitals in Spain. The analysis includes 147 patients switching to DRV/r mx mainly due to toxicity or simplification from March 2009 to June 2011. The Spanish costs (ex-factory price+VAT per patient with HIV RNA<50 copies/ml were calculated, accounting for additional/ switch antiretroviral taken after initial treatment failure and management of adverse events. Cost of adverse events were based on a Spanish publication [1] (updated by the inflation rate until april 2012 The horizon of the analysis was of 48 weeks. Summary of results: Baseline characteristics were: women (30.6%, median age (49 yr, IDU (45%, AIDS stage (32%, HCV coinfected (48%, 40% with advanced fibrosis, length of HIV-RNA<1.7 before DRV/rtv mtx 67.6. Most frequent reasons for switching to DRVr mx were toxicity (62.6% and simplification (23.8%. If a hospital with 600 patients in ART treatment, switched from 10% to 20% of its patients to DRV/r mx, there is a potential to save up to 448,000€/year. Conclusions: Switching to DRV/r mx is a cost-effective strategy that allows more patients to be treated for a fixed budget. Higher cost saving is expected when toxicity is the reason for switching. 48 Weeks Cost-Efficacy analysis: Simplification strategy to DRV/r monotherapy Hospital Budget Impact Analysis: assuming that 10%–20% of 600 patients in ARV treatment simplifies to DRV/r monotherapy

  11. Real-world efficacy, toxicity and clinical management of ipilimumab treatment in metastatic melanoma.

    Science.gov (United States)

    Khoja, Leila; Atenafu, Eshetu G; Ye, Qian; Gedye, Craig; Chappell, Maryanne; Hogg, David; Butler, Marcus O; Joshua, Anthony M

    2016-02-01

    Approved by the Food and Drug Administration in 2011, the anti-cytotoxic T-lymphocyte-associated protein 4 checkpoint inhibitor ipilimumab has delivered a survival benefit of ≥3 years in a subset of metastatic melanoma patients. After participating in the registration trial, patients were treated with this agent in routine practice. Toxicity and efficacy of agents in "real world" settings may differ from trials. The present study aimed to evaluate, with respect to toxicity and outcome, all patients treated with ipilimumab to date at the Princess Margaret Hospital (Toronto, Canada). Patients treated with ipilimumab between 2008 and 2013 were identified, and patient characteristics (age, gender, tumour burden, oncogenic mutation status, number of treatments received and toxicities from treatment) were collected. Progression-free survival (PFS) and overall survival (OS) were calculated from the commencement of ipilimumab treatment. Associations between clinical characteristics and outcome or toxicity were assessed. Between 2008 and 2013, 129 patients with metastatic cutaneous melanoma were treated. Since, during this period, ipilimumab was approved in the second line setting, ipilimumab was delivered in the second or subsequent line in all patients, and 70% did not receive any further anticancer therapy. Immune-related toxicities were observed, the onset of which varied from 1 to 162 days. The majority resolved within 6 weeks of the final treatment, with the exception of endocrinopathies and bowel related toxicity. The median PFS and OS were 2.83 and 8.44 months, respectively. No pre-treatment factor independently predicted toxicity. The number of infusions (4 vs. ≤3) and presence of toxicity were significantly associated with superior survival. The onset of toxicity secondary to ipilimumab could occur later than previously reported. Toxicities were manageable, but required long-term vigilance.

  12. Efficacy of different strategies to treat anemia in children: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    García Olga P

    2010-09-01

    Full Text Available Abstract Background Anemia continues to be a major public health problem among children in many regions of the world, and it is still not clear which strategy to treat it is most effective. Objective To evaluate the efficacy and children's acceptance of several recognized strategies to treat anemia. Methods Non-breastfed children (n = 577, 6 to 43 mo of age, were screened for the trial; 267 were anemic (hemoglobin Results All treatments significantly increased Hb and total iron concentration; ferritin did not change significantly. Groups MMS, IS and IFS increased Hb (g/dL [1.50 (95%CI: 1.17, 1.83, 1.48 [(1.18, 1.78 and 1.57 (1.26, 1.88, respectively] and total iron ((μg/dL [0.15 (0.01, 0.29, 0.19 (0.06, 0.31 and 0.12(-0.01, 0.25, respectively] significantly more than FCF [0.92 (0.64, 1.20] but not to FW group [0.14 (0.04, 0.24]. The prevalence of anemia was reduced to a greater extent in the MMS and IFS groups (72% and 69%, respectively than in the FCF group (45% (p Conclusion The three supplements IS, ISF and MMS increased Hb more than the FCF; the supplements that contained micronutrients (IFS and MMS were more effective for reducing the prevalence of anemia. In general, fortified foods were better accepted by the study participants than supplements. ClinicalTrial.gov Identifier NCT00822380

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

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    Vinay K Hazarey

    2015-01-01

    Full Text Available Introduction: Oral submucous fibrosis (OSF is a chronic, insidious disease that is associated with significant functional morbidity and an increased risk for malignancy. Turmeric and its active ingredient "curcumin′′ are being studied upon as chemopreventive agents in various diseases. The present study aims to determine the efficacy of curcumin in the treatment of OSF. Materials and Methods: Thirty clinically diagnosed OSF patients were divided into two groups, 15 patients in each group from the Outpatient Department. Test group patients were treated with Longvida (curcumin lozenges and control group with Tenovate ointment (clobetasol propionate (0.05%. The treatment was given for 3 months duration and follow-up was done for 6 months. Both the groups were advised for physiotherapy exercises by mouth exercise device. The baseline and follow-up results were compared for IIO (interincisal distance on maximum mouth opening, Visual Analogue Scale (VAS for normal food and VAS for spicy food. Results: The test group showed 5.93 (±2.37 mm increase in mouth opening compared to 2.66 (±1.76 mm of the control group. In relation to VAS scale with spicy and normal food the average reduction was 64 (42-73 and 77 (70.5-82 as compared to 34 (14.5-64.5 and 64 (46-75.5 respectively in control group. The test group results achieved in the treatment span was sustained in the follow-up (P < 0.05 compared to control group which showed statistically significant (P < 0.05 relapse. Conclusion: It can be concluded that combination strategies for the management of OSF which include the stoppage of causative ill habits, appropriate medicinal and physiotherapy management is more efficient than single therapeutic modality. It is evident from the study that curcumin holds good promise in the treatment of OSF in future.

  14. Acceptability, efficacy and safety of two treatment protocols for dental fluorosis: a randomized clinical trial.

    Science.gov (United States)

    Castro, Kaline Silva; Ferreira, Ana Cláudia de Araújo; Duarte, Rosângela Marques; Sampaio, Fábio Correia; Meireles, Sônia Saeger

    2014-08-01

    This parallel randomized clinical trial evaluated the efficacy of two treatments for removing fluorosis stains. Seventy individuals living in an area endemic for fluorosis, with at least four maxillary anterior teeth presenting fluorosis with a Thylstrup and Fejerskov index from 1 to 7, were randomized into two treatment groups (n=35): GI - enamel microabrasion or GII - microabrasion associated with at-home bleaching. Microabrasion was performed using 37% phosphoric acid and pumice and, at-home tooth bleaching was performed with 10% carbamide peroxide. Areas of enamel opacities were recorded by digital camera at baseline and 1-month (1M) after treatment. Two blinded examiners evaluated the reduction in the area (mm(2)) of opacity using software. Two visual analogue scales were used: one for recording tooth sensitivity and/or gingival irritation ranging from 1 (none) to 5 (severe) and the other to evaluate participant satisfaction with the treatment used ranging from 1 (no improvement) to 7 (exceptional improvement). 1M after treatment, both groups showed a significant reduction in the area of enamel opacity (p=0.0001) and there was no difference between groups (p=0.1). Most of the participants from both treatment groups reported no or mild tooth sensitivity and gingival irritation (p>0.05). Participants reported that they were happy with the improvement in dental appearance, however, individuals from GII reported that they were happier than those from GI (p=0.004). Both treatment protocols were effective in reducing fluoride stains, however, when home bleaching was associated to enamel microabrasion, patients reported a major satisfaction with dental appearance. Copyright © 2014 Elsevier Ltd. All rights reserved.

  15. Randomized Clinical Trial to Assess the Efficacy of Radiotherapy in Primary Mediastinal Large B-Lymphoma

    Energy Technology Data Exchange (ETDEWEB)

    Aviles, Agustin, E-mail: agustin.aviles@imss.gob.mx [Oncology Research Unit, Oncology Hospital, National Medical Center, IMSS, Mexico, D. F. (Mexico); Neri, Natividad [Department of Hematology, Oncology Hospital, National Medical Center, IMSS, Mexico, D. F. (Mexico); Fernandez, Raul [Department of Radiation Therapy, Oncology Hospital, National Medical Center, IMSS, Mexico, D. F. (Mexico); Huerta-Guzman, Judith; Nambo, Maria J. [Department of Hematology, Oncology Hospital, National Medical Center, IMSS, Mexico, D. F. (Mexico)

    2012-07-15

    Purpose: We developed a controlled clinical trial to assess the efficacy and toxicity of adjuvant-involved field radiotherapy (IFRT) in patients with primary mediastinal B-cell lymphoma that achieved complete response after the patients were treated with cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab (R-CHOP-14). Methods and Materials: Between January 2001 and June 2004, 124 consecutive patients who were in complete remission after dose dense chemotherapy and rituximab administration (R-CHOP14) were randomly assigned to received IFRT (30 Gy). Sixty-three patients received IFR, and 61 patients did not (control group). Results: The study aimed to include 182 patients in each arm but was closed prematurely because in a security analysis (June 2004), progression and early relapse were more frequent in patients that did not received IFRT. Patients were followed until March 2009, at which point actuarial curves at 10 years showed that progression free-survival was 72% in patients who received IFR and 20% in the control group (p < 0.001), overall survival was 72% and 31%, respectively (p < 0.001). Acute toxicity was mild and well tolerated. Discussion: Adjuvant radiotherapy to sites of bulky disease was the only difference to have an improvement in outcome in our patients; the use of rituximab during induction did not improve complete response rates and did affect overall survival; patients who received rituximab but not IFRT had a worse prognosis. Conclusions: The use of IFRT in patients with primary mediastinal B-cell lymphoma who achieved complete response remain as the best treatment available, even in patients that received rituximab during induction.

  16. Percutaneous Transportal Sclerotherapy with N-Butyl-2-Cyanoacrylate for Gastric Varices: Technique and Clinical Efficacy

    Energy Technology Data Exchange (ETDEWEB)

    Kwak, Hyo Sung; Han, Young Min [Chonbuk National University Medical School and Hospital, Jeonju (Korea, Republic of)

    2008-12-15

    This study was deigned to evaluate the technique and clinical efficacy of the use of percutaneous transportal sclerotherapy with N-butyl-2-cyanoacrylate (NBCA) for patients with gastric varices. Seven patients were treated by transportal sclerotherapy with the use of NBCA. For transportal sclerotherapy, portal vein catheterization was performed with a 6-Fr sheath by the transhepatic approach. A 5-Fr catheter was introduced into the afferent gastric vein and a microcatheter was advanced through the 5-Fr catheter into the varices. NBCA was injected through the microcatheter in the varices by use of the continuous single-column injection technique. After the procedure, postcontrast computed tomography (CT) was performed on the next day and then every six months. Gastroendoscopy was performed at one week, three months, and then every six months after the procedure. The technical success rate of the procedure was 88%. In six patients, gastric varices were successfully obliterated with 1-8 mL (mean, 5.4 mL) of a NBCA-Lipiodol mixture injected via a microcatheter. No complications related to the procedure were encountered. As seen on the follow-up endoscopy and CT imaging performed after six months, the presence of gastric varcies was not seen in any of the patients after treatment with the NBCA-Lipiodol mixture and the use of microcoils. Recurrence of gastric varices was not observed during the followup period. Worsening of esophageal varices occurred in four patients after transportal sclerotherapy. The serum albumin level increased, the ammonia level decreased and the prothrombin time increased at six months after the procedure (p < 0.05). Percutaneous transportal sclerotherapy with NBCA is useful to obliterate gastric varices if it is not possible to perform balloon-occluded retrograde transvenous obliteration.

  17. Clinical Observation on the Efficacy of Xiaoshui Decoction Combined with Intrapleural Perfusion of Cisplatin in Treating Malignant Pleural Effusion

    Institute of Scientific and Technical Information of China (English)

    SHI Zhan; HE Qing-yong; HUA Bao-jin

    2008-01-01

    Objective: To observe the clinical efficacy of Xiaoshui decoction (XSD, 消水方) combined with intrapleural perfusion of cisplatin in the treatment of malignant pleural effusion. Methods: Fifty-one patients with malignant pleural effusion were randomly assigned to two groups. The treated group (26 patients) received oral administration of XSD combined with intrapleural perfusion of cisplatin, and the control group (25 patients) was only treated with intrapleural perfusion of cisplatin. The effects of the short-term efficacy, quality of life scores and clinical symptom scores of malignant pleural effusion were evaluated. Results: The short-term efficacy in the treated group and the control group was 72.0% and 58.3%, respectively, and no significant difference was found (P>0.05). In contrast, the quality of life in the treated group was significantly improved compared to that of the control group (P<0.05), and so was the symptom remission (P<0.05). Conclusions: The combined therapy of XSD and intrapleural perfusion of cisplatin did not show obvious improvement in short-term efficacy, but the therapy remarkably alleviated the symptoms and improved the quality of life of patients.

  18. Adherence to treatment with denosumab, its efficacy and safety in women with postmenopausal osteoporosis in clinical practice

    Directory of Open Access Journals (Sweden)

    N. V. Toroptsova

    2015-01-01

    Full Text Available Adherence to treatment with antiosteoporotic drugs is one of the most important factors contributing to their efficacy during longterm therapy. The adherence is assessed by two main lines: firstly, how long a drug is taken and, secondly, whether its dosage regimen is adhered.Subjects and methods. The paper gives the data of a 12-month prospective follow-up study of 40 women with postmenopausal osteoporosis (OP who initiated treatment with the biological agent denosumab.Results and discussion. After the 12-month follow-up, the significant bone mineral density increase was 4.9% in the lumbar spine, 3.2% in the femoral neck, and 3.0% in the total hip. The previous administration of other antiosteoporotic drugs did not lower the efficiency of denosumab therapy. There were no cases of osteoporotic fractures during 1-year follow-up. 95% of the patients received two denosumab injections (an annual cycle; moreover, 90% of the women were noted to adhere to the dosage regimen. Age, marital status, level of education, time taken to reach the clinic, parental femoral fractures, a history of fractures, duration of OP, and previous therapy had no impact on treatment adherence during 12 months.Conclusion. The one-year prospective follow-up study of the outpatients demonstrated that denosumab was an effective and safe agent for the treatment of patients with postmenopausal OP and its dosage regimen implying its rare subcutaneous administration (twice yearly ensured the high patient adherence to therapy.

  19. Clinical Efficacy of Azithromycin in Typhoid and Paratyphoid Fever in Children

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    Md Atiqul Islam

    2015-01-01

    Full Text Available Background: Azithromycin sensitivity cannot precisely identify the strains of typhoid and paratyphoid fever for successful treatment. Most of the studies show that azithromycin is highly effective in uncomplicated typhoid fever. Very few studies have been carried out in Bangladesh to see the effectiveness and sensitivity of azithromycin in children with uncomplicated typhoid fever. Objective: To assess the clinical response of azithromycin in uncomplicated typhoid fever. Materials and Methods: This randomized clinical trial was conducted in Dhaka Shishu (children Hospital from January to December 2009. Children between 2–12 years of age with characteristic clinical presentation of uncomplicated typhoid fever with positive blood culture for S. typhi or S. paratyphi were included in this study. Patients were treated with oral azithromycin 20 mg/kg/day for 7 days in one group and intravenous ceftriaxone 100 mg/kg/day in another group. Effectiveness and sensitivity pattern were documented and compared. Results: Fifty patients were allocated randomly with azithromycin and 48 with ceftriaxone. Twenty two percent of the subjects were below 5 years and 78% above 5 years. Average time of defervescence was 4.44 ± 1.25 days in azithromycin group and 4.38 ± 1.21 days in ceftriaxone group. Response to treatment in both groups was excellent: 94% in azithromycin and 97.9% in ceftriaxone groups. The occurrence of complication was very low in both groups. Eighteen percent showed resistance to azithromycin and 2.1% to ceftriaxone. In azithromycin sensitive group 97.6% showed improvement and in resistant group 77.8% showed improvement. A good percentage of patients who were resistant to azithromycin showed clinical improvement following treatment with this drug. Conclusion: Current study recommends that azithromycin is effective in the treatment of enteric fever in children. The study also shows that some patients resistant to azithromycin showed clinical

  20. Lack of prophylactic efficacy of oral maraviroc in macaques despite high drug concentrations in rectal tissues.

    Science.gov (United States)

    Massud, Ivana; Aung, Wutyi; Martin, Amy; Bachman, Shanon; Mitchell, James; Aubert, Rachael; Solomon Tsegaye, Theodros; Kersh, Ellen; Pau, Chou-Pong; Heneine, Walid; García-Lerma, J Gerardo

    2013-08-01

    Maraviroc (MVC) is a potent CCR5 coreceptor antagonist that is in clinical testing for daily oral pre-exposure prophylaxis (PrEP) for HIV prevention. We used a macaque model consisting of weekly SHIV162p3 exposures to evaluate the efficacy of oral MVC in preventing rectal SHIV transmission. MVC dosing was informed by the pharmacokinetic profile seen in blood and rectal tissues and consisted of a human-equivalent dose given 24 h before virus exposure, followed by a booster postexposure dose. In rectal secretions, MVC peaked at 24 h (10,242 ng/ml) with concentrations at 48 h that were about 40 times those required to block SHIV infection of peripheral blood mononuclear cells (PBMCs) in vitro. Median MVC concentrations in rectal tissues at 24 h (1,404 ng/g) were 30 and 10 times those achieved in vaginal or lymphoid tissues, respectively. MVC significantly reduced macrophage inflammatory protein 1β-induced CCR5 internalization in rectal mononuclear cells, an indication of efficient binding to CCR5 in rectal lymphocytes. The half-life of CCR5-bound MVC in PBMCs was 2.6 days. Despite this favorable profile, 5/6 treated macaques were infected during five rectal SHIV exposures as were 3/4 controls. MVC treatment was associated with a significant increase in the percentage of CD3(+)/CCR5(+) cells in blood. We show that high and durable MVC concentrations in rectal tissues are not sufficient to prevent SHIV infection in macaques. The increases in CD3(+)/CCR5(+) cells seen during MVC treatment point to unique immunological effects of CCR5 inhibition by MVC. The implications of these immunological effects on PrEP with MVC require further evaluation.

  1. Nootropic efficacy of Satvavajaya Chikitsa and Ayurvedic drug therapy: A comparative clinical exposition.

    Science.gov (United States)

    Amin, Hetal; Sharma, Rohit

    2015-01-01

    Ayurveda is known for philosophical basis, and its approach to psychological ailments is quite different from conventional system of management. Satvavajaya Chikitsa (Ayurvedic psychotherapy) is a nonpharmacological approach aimed at control of mind and restraining it from unwholesome Artha (objects) or stressors. Withdrawal of the mind from unwholesome objects is known as Sattvavajaya Chikitsa or it is a treatment by Self Control. Charaka defines it as a mind controlling therapy in which a stress has been laid on restraining of mind from unwholesome objects. Thus, it includes all the methods of Manonigraha and Astanga Yoga (Yogic techniques) too. Indian philosophy portrays Astanga Yoga as a primary tool to control mind; hence it can be used as Satvavajaya Chikitsa. To evaluate efficacy of Satvavajaya Chikitsa and Aushadhiya Medhya Chikitsa for improving Smriti in young healthy volunteers. Totally, 102 physically healthy volunteers between age group 16 and 25 years were divided into two groups. In Group A, Satvavajaya Chikitsa was adopted in form of Yogic procedures such as Asana, Pranayama, Chanting etc., with counseling and placebo. Group B was Shankhapushpi tablets made with whole part of Shankhpushpi plant was used as standard control. The Weschler's memory scale (WMS) was adopted to collect data before and after intervention period of 2 months. Paired and Unpaired t-test were used for analysis the data in Sigmastat Software. Group A (Satvavajaya + placebo) with counseling showed statistically highly significant result (P WMS.

  2. Clinical Efficacy of Fluoride Varnish and Low-Level Laser Radiation in Treating Dentin Hypersensitivity.

    Science.gov (United States)

    Dantas, Euler Maciel; Amorim, Fernanda Kyarelly de Oliveira; Nóbrega, Fernando José de Oliveira; Dantas, Poliana Medeiros Cunha; Vasconcelos, Rodrigo Gadelha; Queiroz, Lélia Maria Guedes

    2016-01-01

    The objective of this study was to compare the efficacy of fluoride varnish (Fluorniz(r)) and irradiation with a gallium-arsenide-aluminum diode laser in the treatment of cervical dentin hypersensitivity. Cervical dentin hypersensitivity (CDH) is a painful condition that is highly prevalent in the world's adult population, with one in six patients presenting this symptom. Eighty-six teeth were divided into two groups: Group 1, teeth treated with Fluorniz; Group 2, teeth irradiated with a GaAlAs laser at a 4 J/cm2 dose. The two treatments were applied to the buccal cervical region in four sessions, at intervals of 72 to 96 h. The response of the patient to tactile and thermal-evaporative stimuli was rated on a visual analog scale. The results showed a reduction of hypersensitivity in response to tactile and thermal-evaporative stimulation at the end of treatment in both groups. In conclusion, short-term treatment with Fluorniz was found to be more effective than low-level laser radiation in reducing cervical dentin hypersensitivity.

  3. Micronised fenofibrate: a review of its pharmacodynamic properties and clinical efficacy in the management of dyslipidaemia.

    Science.gov (United States)

    Adkins, J C; Faulds, D

    1997-10-01

    Micronised fenofibrate is a new formulation of the fibric acid derivative fenofibrate. It is indicated for the treatment of patients with type IIa, IIb, III or IV dyslipidaemia who have failed to respond to dietary control or other nonpharmacological interventions. Micronised fenofibrate has improved absorption characteristics compared with the standard preparation, allowing a lower daily dosage and once-daily administration. The lipid-modifying profile of micronised fenofibrate is characterised by a decrease in low density lipoprotein (LDL) and total cholesterol levels, a marked reduction in elevated plasma triglyceride levels and an increase in high density lipoprotein (HDL) cholesterol levels. Consistent with the standard formulation, which is administered as 300mg daily in divided doses, the micronised preparation has demonstrated efficacy in the treatment of type IIa, IIb and IV primary dyslipidaemias but at a lower daily dosage of 200mg once daily. Because of its significant triglyceride-lowering effect, micronised fenofibrate appears to be of greatest benefit in patients with hypertriglyceridaemia (with or without hypercholesterolaemia), including patients with type 2 (non-insulin-dependent) diabetes mellitus and dyslipidaemia. In the comparisons available, micronised fenofibrate 200mg once daily was of similar efficacy to or less effective than the HMG-CoA reductase inhibitors simvastatin 20mg daily and pravastatin 20mg daily at reducing LDL and total cholesterol levels. However micronised fenofibrate produced greater improvements in triglyceride and, generally, HDL cholesterol levels than both simvastatin and pravastatin. Data on the long term tolerability of micronised fenofibrate are limited. However, data from a large short term (3-month) study have indicated that gastrointestinal disorders are the most frequent adverse events associated with therapy. Elevations in serum transaminase and creatine phosphokinase levels have been reported rarely with

  4. Cefditoren versus levofloxacin in patients with exacerbations of chronic bronchitis: serum inflammatory biomarkers, clinical efficacy, and microbiological eradication

    OpenAIRE

    Blasi F; Tarsia P; Mantero M; Morlacchi LC; Piffer F

    2013-01-01

    Francesco Blasi, Paolo Tarsia, Marco Mantero, Letizia C Morlacchi, Federico PifferDepartment of Pathophysiology and Transplantation, University of Milan, IRCCS Fondazione Cà Granda Ospedale Maggiore Policlinico, Milan, ItalyBackground: The aim of this open-label, randomized, parallel-group pilot study was to evaluate the efficacy of cefditoren pivoxil and levofloxacin in terms of speed of reduction in inflammatory parameters, clinical recovery, and microbiological eradication.Metho...

  5. Methodology and lessons-learned from the efficacy clinical trial of the pentavalent rotavirus vaccine in Bangladesh.

    Science.gov (United States)

    Zaman, K; Yunus, M; El Arifeen, Shams; Azim, Tasnim; Faruque, A S G; Huq, Ehsanul; Hossain, Ilias; Luby, Stephen P; Victor, John C; Dallas, Michael J; Lewis, Kristen D C; Rivers, Stephen B; Steele, A Duncan; Neuzil, Kathleen M; Ciarlet, Max; Sack, David A

    2012-04-27

    An efficacy clinical trial with pentavalent rotavirus vaccine (PRV), RotaTeq(®), was conducted at Matlab field site of ICDDR,B, Bangladesh from March 2007 to March 2009. The methodology, including operation logistics, and lessons-learned are described in this report. Vaccination was organized at 41 fixed-site clinics twice/month. A total of 1136 infants were randomized 1:1 to receive 3 doses of PRV/placebo at approximately 6-, 10-, and 14-weeks of age with routine vaccines of the Expanded Programme on Immunization (EPI) schedule. Twelve field-workers routinely visited study participants for safety and efficacy follow-up. The study was conducted following good clinical practices and maintaining cold-chain requirements. There were no temperature deviations of clinical vaccine supplies. Data entry was done using the source documents to a central database developed by the sponsor which was linked to web. Among enrolled infants, 1128 (99.3%) received 3 doses of PRV/placebo and efficacy follow-up was conducted for a median of 554 days. For the evaluation of immunogenicity, blood samples were collected from 150 participants predose 1 and from 147 (98%) of the same participants post dose 3. Stool samples were collected from 778 (99.9%) acute gastroenteritis episodes among children who reported to diarrhoea treatment centres. Thirty-nine serious adverse events, including 6 deaths, occurred among study participants. The efficacy of PRV against severe rotavirus gastroenteritis was 42.7% through the entire follow-up period; serum anti-rotavirus IgA response was 78.1%. Inclement weather, difficult transportation, and movement of study participants were some of the challenges identified. This is the first vaccine trial in rural Bangladesh with online data entry. The study was well accepted in the community and was completed successfully. Copyright © 2011 Elsevier Ltd. All rights reserved.

  6. Efficacy of mouth rinses on dental plaque and gingivitis: A randomized, double-blind, placebo-controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Arun Shyam

    2014-01-01

    Full Text Available Introduction: Over the years chlorhexidine (CHX, triclosan and sodium fluoride (NaF mouth rinses are used alone or combined in the prevention of dental diseases. However, at present little is known about the combined effects of NaF + triclosan and CHX + NaF + triclosan mouth rinses on reducing dental plaque and gingivitis. Aim: The aim was to determine the efficacy of mouth rinses used as adjuncts to regular oral hygiene measures on reducing dental plaque and gingivitis. Materials and Methods: A randomized, placebo-controlled, double-blind, parallel-group study was conducted for 6-month, among 12-15 years old school children in Nellore, India. Eligible subjects (n = 210 with consent were randomly allocated to four groups and were provided with a mouth rinse (Group A = 0.2% CHX; Group B = 0.05% sodium fluoride + 0.03% triclosan; Group C = 0.2% CHX + 0.05% sodium fluoride + 0.03% triclosan; Group D = Placebo. All subjects used 10 ml of mouth rinse, once daily for 60 s. The clinical parameters evaluated were plaque index (PlI and gingival Index (GI. Statistical significance within and between four groups was tested using one-way analysis of variance (ANOVA, repeated measures ANOVA with post-hoc and paired t-test. Results: At the end of clinical trial, the three test groups showed statistically significant (P < 0.001 reduction in PlI and GI scores compared with placebo group. Conclusion: The active agents demonstrated highly potent antiplaque and antigingivitis properties when compared to placebo.

  7. Clinical efficacy of hypofractionated high-dose radiotherapy combined with gefitinib for the elderly non-small cell lung cancer%低分割放疗联合吉非替尼治疗老年非小细胞肺癌疗效观察

    Institute of Scientific and Technical Information of China (English)

    李小龙; 党亚正; 陆婉玲

    2013-01-01

    Objective To investigate the efficacy and toxicity of three-dimensional conformal radiotherapy combined with gefitinib in elderly NSCLC.Methods 27 cases of elderly NSCLC patients were analyzed.Results The efficacy rate was 66.7%.1-year survival rates were 63.0%.The incidence of radiation pneumonitis was 25.9%.The incidence of radiation esophagitis was 29.6%.The incidence of rash was 37.0%,and the incidence of diarrhea was 22.2%.Conclusion The three-dimensional conformal Hypofractionated high-dose radiotherapy combined with gefitinib for elderly non-small cell lung cancer is safely and definitely.%目的 探讨三维适形低分割放疗联合吉非替尼治疗老年非小细胞肺癌(NSCLC)的疗效及不良反应.方法 对27例老年NSCLC患者实施低分割放疗联合吉非替尼治疗,分割方案:2.5Gy/d、5f/w,总剂量:35~55Gy;口服吉非替尼250mg,1次/日.结果 3个月近期有效率(CR+PR)66.7%,1年生存率63.0%;放射性肺炎发生率25.9%,放射性食管炎发生率29.6%,皮疹发生率37.0%,腹泻发生率22.2%.结论 三维适形低分割放疗联合吉非替尼治疗安全有效,不良反应未见明显增加.

  8. Efficacy of Corticosteroids in Community-acquired Pneumonia A Randomized Double-Blinded Clinical Trial

    NARCIS (Netherlands)

    Snijders, Dominic; Daniels, Johannes M. A.; de Graaff, Casper S.; van der Werf, Tjip S.; Boersma, Wim G.

    2010-01-01

    Rationale: Some studies have shown a beneficial effect of corticosteroids in patients with community-acquired pneumonia (CAP), possibly by diminishing local and systemic antiinflammatory host response. Objectives: To assess the efficacy of adjunctive prednisolone treatment in patients hospitalized w

  9. The efficacy and safety of high-dose arbekacin sulfate therapy (once-daily treatment) in patients with MRSA infection.

    Science.gov (United States)

    Yamamoto, Yoshihiro; Izumikawa, Koichi; Hashiguchi, Koji; Fukuda, Yuichi; Kobayashi, Tsutomu; Kondo, Akira; Inoue, Yuichi; Morinaga, Yoshitomo; Nakamura, Shigeki; Imamura, Yoshifumi; Miyazaki, Taiga; Kakeya, Hiroshi; Yanagihara, Katsunori; Kohno, Shigeru

    2012-04-01

    The efficacy and safety of once-daily high-dose arbekacin sulfate therapy for methicillin-resistant Staphylococcus aureus (MRSA) infection were evaluated, with analysis of their relationship to blood drug levels. The study was conducted in patients with pneumonia or sepsis, the cause of which was suspected to be MRSA, who were admitted to the Nagasaki University Hospital or its affiliated hospitals between January 2009 and December 2010. The initial drug dose was set at a level expected to yield the goal peak of 20 μg/ml and a trough level of less than 2 μg/ml, using the Habekacin Therapeutic Drug Monitoring analysis software. Thirteen patients were enrolled: 10 patients had pneumonia and 3 patients had sepsis. Patient mean age was 72.0 years; mean initial drug dose was 269.2 mg. Clinical efficacy at completion of treatment and bacterial eradication-reduction were achieved in 66.7% (6/9) and 62.5% (5/8) of patients, respectively. Incidence of adverse reactions was 38.5% (5/13). In analysis of efficacy in relationship to serum drug levels, the peak drug level was 22.7 ± 5.50 μg/ml, on average, and 15 μg/ml or higher in all 6 responders. Also, in patients with renal dysfunction, it seemed to be essential to ensure a certain peak drug level and to control the trough level appropriately. Although the number of patients was limited, once-daily high-dose arbekacin sulfate therapy may be highly effective, without posing any major safety problems. Further larger-scale studies are needed.

  10. Meta-analysis of efficacy and safety of intravenous ferric carboxymaltose (Ferinject from clinical trial reports and published trial data

    Directory of Open Access Journals (Sweden)

    Gaskell Helen

    2011-09-01

    Full Text Available Abstract Background Recommendations given for intravenous iron treatment are typically not supported by a high level of evidence. This meta-analysis addressed this by summarising the available date from clinical trials of ferric carboxymaltose using clinical trial reports and published reports. Methods Clinical trial reports were supplemented by electronic literature searches comparing ferric carboxymaltose with active comparators or placebo. Various outcomes were sought for efficacy (attainment of normal haemoglobin (Hb, increase of Hb by a defined amount, for example, together with measures of harm, including serious adverse events and deaths. Results Fourteen studies were identified with 2,348 randomised patients exposed to ferric carboxymaltose, 832 to oral iron, 762 to placebo, and 384 to intravenous iron sucrose. Additional data were available from cohort studies. Intravenous ferric carboxymaltose was given up to the calculated iron deficit (up to 1,000 mg in one week for iron deficiency anaemia secondary to chronic kidney disease, blood loss in obstetric and gynaecological conditions, gastrointestinal disease, and other conditions like heart failure. The most common comparator was oral iron, and trials lasted 1 to 24 weeks. Intravenous ferric carboxymaltose improved mean Hb, serum ferritin, and transferrin saturation levels; the mean end-of-trial increase over oral iron was, for Hb 4.8 (95% confidence interval 3.3 to 6.3 g/L, for ferritin 163 (153 to 173 μg/L, and for transferrin saturation 5.3% (3.7 to 6.8%. Ferric carboxymaltose was significantly better than comparator in achievement of target Hb increase (number needed to treat (NNT 6.8; 5.3 to 9.7 and target Hb NNT (5.9; 4.7 to 8.1. Serious adverse events and deaths were similar in incidence in ferric carboxymaltose and comparators; rates of constipation, diarrhoea, and nausea or vomiting were lower than with oral iron. Conclusions This review examined the available trials of

  11. An intervention for reducing secondary traumatization and improving professional self-efficacy in well baby clinic nurses following war and terror: a random control group trial.

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    Berger, Rony; Gelkopf, Marc

    2011-05-01

    Due to the terror and war-related situation in Israel, well baby clinic nurses dealing with a large number of traumatized and highly distressed infants, toddlers and their parents have become overwhelmed. (1) Assess the level of secondary traumatization, including lack of compassion satisfaction, burnout and compassion fatigue of well baby clinic nurses living under chronic threat of war and terror. (2) Assess the efficacy of an intervention aimed at providing well baby clinic nurses with psycho-educational knowledge pertaining to stress and trauma in infants, young children and parents. This intervention provides the nurses with screening tools for identifying children and parents at risk of developing stress-related problems and equips them with stress management techniques. Quasi-random control trial. The intervention took place in Israel, in war (North) and terror (South) affected areas. Ninety well baby clinic nurses from the most war and terror affected areas in Israel were approached, 42 were randomly assigned the experimental intervention and 38 served as a waiting list group. The intervention was comprised of 12 weekly 6-h sessions. Each session included theoretical knowledge, experiential exercises based on the nurses' work or personal life experience, and the learning of skills accompanied by homework assignments. Participants were assessed on self-report measures of secondary traumatization, professional self-efficacy, hope, sense of mastery and self-esteem before and after the intervention. (1) Well baby clinic nurses were found to have elevated secondary traumatization levels. (2) Compared to the waiting list group, the intervention group improved significantly on the professional self-efficacy measure as well as reducing the level of secondary traumatization. Furthermore, improvement on all secondary traumatization measures covaried with the improvement on the professional self-efficacy assessments. Based on additional informal reports, the

  12. Fesoterodine clinical efficacy and safety for the treatment of overactive bladder in relation to patient profiles: a systematic review.

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    Chapple, Christopher; Oelke, Matthias; Kaplan, Steven A; Scholfield, David; Arumi, Daniel; Wagg, Adrian S

    2015-06-01

    To summarize published evidence on the pharmacology, efficacy, and safety of fesoterodine for the treatment of overactive bladder (OAB) symptoms in relation to patient clinical and demographic profiles. A systematic review of published articles on fesoterodine was conducted via a PubMed search. Articles were identified using the search term fesoterodine, with limits of human species and abstract available. Review and meta-analysis articles, validation studies, articles focused on treatment compliance/adherence, meeting abstracts, and articles not focused on oral fesoterodine administration in human subjects were excluded. Data from retained articles were summarized descriptively. Of 137 articles identified, 61 (15 articles on the pharmacology and 46 articles on the efficacy and/or safety of fesoterodine) met inclusion criteria. Superiority trials demonstrated the additional efficacy of fesoterodine 8 mg versus fesoterodine 4 mg and tolterodine extended release 4 mg in treating OAB. Prospective trials in specific patient populations indicated beneficial effects of fesoterodine in elderly patients, vulnerable elderly patients, patients dissatisfied with or with a suboptimal response to previous antimuscarinic therapy, patients with urge urinary incontinence (UUI) or nocturnal urgency, and men with persistent LUTS during alpha-blocker treatment. With two effective doses, the fesoterodine dose can be adjusted to achieve optimal efficacy and tolerability in individual patients. The most common adverse events during fesoterodine treatment are dry mouth and constipation. Extensive evidence demonstrates the efficacy and safety of fesoterodine in relieving OAB symptoms, including urgency, urinary frequency, UUI, and nocturnal urgency, in patients with various clinical and demographic profiles. Trial results provide valuable information on fesoterodine treatment in specific patient populations, including both elderly and vulnerable elderly patients. Potential

  13. Efficacy of Crest Herbal Toothpaste in “Clearing Internal Heat”: A Randomized, Double-Blind Clinical Study

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    Jia-Xu Chen

    2013-01-01

    Full Text Available Objective. Evaluation of the efficacy of Crest Herbal Crystal Toothpaste in “clearing internal heat.” Methods. This was a randomized, double-blind, controlled parallel design clinical test of a product that was already on the market. 72 subjects were randomly assigned to control group (group A with Colgate Herbal Salty Toothpaste or treatment group (group B with Crest Herbal Crystal Toothpaste with ratio of 1 : 2. Subjects were instructed to brush with 1g toothpaste for 2 minutes each time, 2 times per day in a 4-aweek test period; measurement with the rating scale on the efficacy of “clearing internal heat” for the herbal toothpaste was done at baseline, 2 weeks, and 4 weeks of toothpaste usage. Results. The rating scale on efficacy of “clearing internal heat” for the herbal toothpaste reveals that the primitive points of 72-case intention-to-treat (ITT analysis and 67-case per-protocol (PP analysis for subjects in group A and subjects in group B were found to be reduced progressively with statistical significance (P<0.05. The overall effective rates for group A and group B were, respectively, 62.50%, 56.25% (ITT and 62.50%, 60.64% (PP. The statistical results indicated that the symptoms of fire-heat for both groups of subjects have been improved after application of toothpaste. Conclusion. The efficacy of Crest Herbal Crystal Toothpaste in “clearing internal heat” was confirmed by the trial as compared to Colgate Herbal Salty Toothpaste. And its efficacy was objectively evaluated by the rating scale on efficacy of “clearing internal heat.”

  14. Relationship between viscoelastic properties of soft denture liners and clinical efficacy

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    Hiroshi Murata

    2008-10-01

    Full Text Available Soft denture liners are applied for denture wearers who cannot tolerate a hard-based denture due to a thin and non-resilient oral mucosa and/or severe alveolar resorption. This material distributes and absorbs masticatory forces by means of the cushioning effect. Clinical success of the materials depends both on their viscoelastic properties and on durability. Acrylic resins and silicones are mainly available for permanent soft liners. The acrylic permanent soft liners demonstrate viscoelastic behavior while silicone permanent soft liners demonstrate elastic behavior. The improvement in masticatory function is greater in dentures lined with the acrylic materials than in those lined with silicone products. However, the acrylic materials exhibit a more marked change in viscoelastic properties and loss of cushioning effect over time than silicones. From the standpoint of durability, the silicones are preferred. It is important to understand viscoelastic properties and durability of each soft denture liner and to select the material according to the clinical situations and purposes. The ideal permanent soft liners have a relatively high value of loss tangent and storage modulus, and high durability. Further research is necessary to develop the ideal soft denture liner.

  15. A clinical investigation of the efficacy of two dentifrices for the reduction of supragingival calculus formation.

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    Schiff, Thomas; Delgado, Evaristo; DeVizio, William; Proskin, Howard M

    2008-01-01

    The objective of this double-blind clinical study, conducted in harmony with Volpe-Manhold design for studies of dental calculus, was to compare the efficacy of a dentifrice containing 0.3% triclosan/2.0% polyvinylmethyl ether/maleic acid (PVM/MA) copolymer/0.243% sodium fluoride in a 17% dual silica base (Colgate Total Advanced Toothpaste) to that of a commercially available dentifrice containing 0.243% sodium fluoride in a silica base (Crest Cavity Protection Toothpaste) with respect to the reduction of supragingival calculus formation. Adult male and female subjects from the San Francisco area were entered into the eight-week pre-test phase of the study. Subjects received an evaluation of oral soft and hard tissues and were given a complete oral prophylaxis. They were provided with a non-tartar control placebo dentifrice and a soft-bristled adult toothbrush, and were instructed to brush their teeth twice daily (morning and evening) for one minute. After eight weeks of using the placebo dentifrice, subjects were examined for baseline supragingival calculus formation using the Volpe-Manhold Calculus Index. Qualifying subjects were randomized into two treatment groups which were balanced for gender and baseline calculus scores. All subjects entered into the twelve-week test phase were given a complete oral prophylaxis, and were provided with their assigned dentifrice and a soft-bristled adult toothbrush for home use. Subjects were instructed to brush their teeth for one minute twice daily (in the morning and evening). Prior to each study visit, subjects refrained from brushing their teeth and eating and drinking for four hours. Seventy-seven (77) subjects complied with the protocol and completed the study. At the twelve-week examination, the Test Dentifrice group presented a mean Volpe-Manhold Calculus Index score of 13.22 and the Control Dentifrice group presented a score of 20.29. After twelve weeks of product use, the Test Dentifrice group exhibited 34.8% less

  16. Systematic Evaluation on Clinical Efficacy of External Application of Traditional Chinese Medicine in Treatment of Breast Hyperplasia

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    Yan-hong Lyu

    2015-12-01

    Full Text Available Abstract Objective: To evaluate the clinical efficacy of external application of traditional Chinese medicine (TCM in the treatment of breast hyperplasia. Methods: Randomized controlled clinical trial literatures on external application of TCM in the treatment of breast hyperplasia published in PubMed, Excerpta Medica Database (EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL , China National Knowledge Infrastructure Database (CNKI and Chinese Biomedical Abstract Database (CBM from January 2000 to August 2015 were retrieved, and screened by researchers to data extraction. RevMan 5.3 was applied for Meta analysis. Results: A total of 15 clinical trials with 2 107 patients with breast hyperplasia were included, in which 1 151 were divided into treatment group treated with external application of TCM while 956 into control group. Meta analysis indicated that the clinical response rate and clinical symptom score improvement (lump size as well as serum levels of estradiol (E2, progesterone (P and prolactin (PRL in treatment group were superior to the control group and the differences were statistically significant (P<0.05. Although external application of TCM had a tendency of alleviating clinical symptom (lump pain, hardness and range as well as complicated symptoms, there was no statistically significant difference between two groups (P>0.05. Conclusion: External application of TCM, to some extent, can improve the clinical efficacy in the treatment of breast hyperplasia, and it is necessary to carry out higher-quality, multicenter, large-scale, prospective and double-blind clinical experiments for further validation.

  17. Clinical efficacy and safety of Tevagrastim® (XM02, a biosimilar recombinant human granulocyte colony-stimulating factor

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    Bagalagel A

    2013-08-01

    Full Text Available Alaa Bagalagel,1,2 Abdulaziz Mohammed,1,2 Karen MacDonald,3 Ivo Abraham1,3–5 1Center for Health Outcomes and PharmacoEconomic Research, University of Arizona, Tucson, AZ, USA; 2College of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia; 3Matrix45, Tucson, AZ, USA; 4Department of Pharmacy Practice and Science, University of Arizona, Tucson, AZ, USA; 5Department of Family and Community Medicine, College of Medicine, University of Arizona, Tucson, AZ, USA Abstract: Since the expiration of the patent for filgrastim in Europe in 2006, the European Medicines Agency has approved three biosimilar granulocyte colony-stimulating factors, while the US Food and Drug Administration has approved one of these agents. Using the European Medicines Agency’s and the Food and Drug Administration’s regulatory reports and scientific publications, we review the evidence about the clinical efficacy and safety of XM02 (Tevagrastim® relative to the originator product filgrastim (Neupogen®. Clinical efficacy is assessed in terms of equivalence of XM02 and Neupogen®, while safety is evaluated in terms of immunogenicity, bone pain, splenomegaly, allergic reactions, acute respiratory distress syndrome, and mortality. Three Phase III studies in breast cancer patients treated with docetaxel/doxorubicin chemotherapy, lung cancer patients receiving platinum-based chemotherapy, and non-Hodgkin’s lymphoma receiving chemotherapy are reviewed. Also included is a postapproval, single-center experience study on peripheral blood stem mobilization. Based on the available therapeutic equivalence and safety data, the clinical and safety outcomes of XM02 are likely to be similar to those of Neupogen®. XM02 and Neupogen® can be considered interchangeable in the approved indications. Patients previously on Neupogen® and converted to XM02 can be expected to show similar efficacy and safety outcomes. Keywords: biosimilars, biosimilar pharmaceuticals, efficacy, safety

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

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    Katarzyna Kapuścińska

    2016-03-01

    Full Text Available 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.

  19. Nootropic efficacy of Satvavajaya Chikitsaand Ayurvedic drug therapy: A comparative clinical exposition

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    Hetal Amin

    2015-01-01

    Full Text Available Introduction: Ayurveda is known for philosophical basis, and its approach to psychological ailments is quite different from conventional system of management. Satvavajaya Chikitsa (Ayurvedic psychotherapy is a nonpharmacological approach aimed at control of mind and restraining it from unwholesome Artha (objects or stressors. Withdrawal of the mind from unwholesome objects is known as Sattvavajaya Chikitsa or it is a treatment by Self Control. Charaka defines it as a mind controlling therapy in which a stress has been laid on restraining of mind from unwholesome objects. Thus, it includes all the methods of Manonigraha and Astanga Yoga (Yogic techniques too. Indian philosophy portrays Astanga Yoga as a primary tool to control mind; hence it can be used as Satvavajaya Chikitsa. Aims and Objectives: To evaluate efficacy of Satvavajaya Chikitsa and Aushadhiya Medhya Chikitsa for improving Smriti in young healthy volunteers. Materials and Methods: Totally, 102 physically healthy volunteers between age group 16 and 25 years were divided into two groups. In Group A, Satvavajaya Chikitsa was adopted in form of Yogic procedures such as Asana, Pranayama, Chanting etc., with counseling and placebo. Group B was Shankhapushpi tablets made with whole part of Shankhpushpi plant was used as standard control. The Weschler′s memory scale (WMS was adopted to collect data before and after intervention period of 2 months. Paired and Unpaired t-test were used for analysis the data in Sigmastat Software. Results: Group A (Satvavajaya + placebo with counseling showed statistically highly significant result (P < 0.001 in verbal retention for similar pair, verbal retention for dissimilar pair and visual immediate tests; while Group B (Shankhapushpi tablets showed significant result (P < 0.01 in auditory delayed, visual delayed, auditory recognition and visual recognition tests. Conclusion: Satvavajaya Chikitsa shows better results in immediate recollection in terms of

  20. Clinical efficacy, safety, and tolerability of once-daily fesoterodine in subjects with overactive bladder.

    Science.gov (United States)

    Chapple, Christopher; Van Kerrebroeck, Philip; Tubaro, Andrea; Haag-Molkenteller, Cornelia; Forst, Hans-Theo; Massow, Ute; Wang, Joseph; Brodsky, Marina

    2007-10-01

    To determine the efficacy, tolerability, and safety of fesoterodine in subjects with overactive bladder (OAB). This was a multicentre, randomised, double-blind, placebo- and active-controlled trial with tolterodine extended release (ER) to assess the efficacy and safety of fesoterodine. Eligible subjects (> or =18 yr) with increased micturition frequency and urgency and/or urgency urinary incontinence (UUI) were randomised to placebo, fesoterodine 4 mg, fesoterodine 8 mg, or tolterodine ER 4 mg for 12 wk. The primary efficacy variable was a change from baseline to week 12 in micturitions per 24 h. Co-primary end points included change from baseline to week 12 in UUI episodes per 24 h and Treatment Response ("yes" or "no," based on four-point treatment benefit scale). Secondary efficacy variables included mean volume voided per micturition, continent days per week, and number of urgency episodes. At the end of treatment, subjects taking fesoterodine 4 and 8 mg had significant (pfesoterodine 8 mg at most end points. Both doses of fesoterodine were significantly better than placebo in improving the symptoms of OAB and produced a significantly greater Treatment Response versus placebo. Efficacy was more pronounced with fesoterodine 8 mg compared with the other treatments. Active treatments were well tolerated.

  1. [A prospective multicenter randomized controlled clinical study on the efficacy and safety of Guaifenesin compound pseudoephedrine hydrochloride oral solution].

    Science.gov (United States)

    Lu, Quan

    2010-03-01

    To evaluate efficacy and safety of Guaifenesin compound pseudoephedrine hydrochloride oral solution for the treatment of cough, expectoration, nasal congestion and runny nose in children. This was a prospective multicenter randomized single-blind, parallel-controlled clinical study. A total of 10 centers participated in this study, the actual number of cases in line with the program was 412, of whom 205 cases in trial group were treated with Guaifenesin compound pseudoephedrine hydrochloride oral solution, and 207 cases in control group with ambroxol hydrochloride oral solution, treatment of both groups persisted for 7 days. The improvement rate of each single symptom and the combined symptoms and the overall effective rate were compared between the two groups. The adverse drug reactions and compliance were assessed as well. The treatment of both groups showed efficacy. Except sputum stickiness, the improvement of all symptoms in trial group was superior to that in the control group on the 3rd day after treatment (P Guaifenesin compound pseudoephedrine hydrochloride oral solution was 82.9% and the overall efficacy rate was 89.3%. Guaifenesin compound Pseudoephedrine hydrochloride oral solution had higher compliance and its adverse event rate was merely 0.92%. Guaifenesin compound pseudoephedrine hydrochloride oral solution showed significant efficacy and safety in children for treatment of cough, expectoration, nasal congestion and runny nose caused by common cold or acute tracheobronchitis.

  2. Clinical relevance of the ROC and free-response paradigms for comparing imaging system efficacies.

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    Chakraborty, D P

    2010-01-01

    Observer performance studies are widely used to assess medical imaging systems. Unlike technical/engineering measurements observer performance include the entire imaging chain and the radiologist. However, the widely used receiver operating characteristic (ROC) method ignores lesion localisation information. The free-response ROC (FROC) method uses the location information to appropriately reward or penalise correct or incorrect localisations, respectively. This paper describes a method for improving the clinical relevance of FROC studies. The method consists of assigning appropriate risk values to the different lesions that may be present on a single image. A high-risk lesion is one that is critical to detect and act upon, and is assigned a higher risk value than a low-risk lesion, one that is relatively innocuous. Instead of simply counting the number of lesions that are detected, as is done in conventional FROC analysis, a risk-weighted count is used. This has the advantage of rewarding detections of high-risk lesions commensurately more than detections of lower risk lesions. Simulations were used to demonstrate that the new method, termed case-based analysis, results in a higher figure of merit for an expert who detects more high-risk lesions than a naive observer who detects more low-risk lesions, even though both detect the same total number of lesions. Conventional free-response analysis is unable to distinguish between the two types of observers. This paper also comments on the issue of clinical relevance of ROC analysis vs. FROC for tasks that involve lesion localisation.

  3. A multifunctional drug combination shows highly potent therapeutic efficacy against human cancer xenografts in athymic mice.

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    Xiu-Jun Liu

    Full Text Available The tumor microenvironment plays a crucial role during tumor development. Integrated combination of drugs that target tumor microenvironment is a promising approach to anticancer therapy. Here, we report a multifunctional combination of low-cytotoxic drugs composed of dipyridamole, bestatin and dexamethasone (DBDx which mainly acts on the tumor microenvironment shows highly potent antitumor efficacy in vivo. In mouse hepatoma H22 model, the triple drug combination showed synergistic and highly potent antitumor efficacy. The combination indices of various combinations of the triple drugs were between 0.2 and 0.5. DBDx inhibited the growth of a panel of human tumor xenografts and showed no obvious systemic toxicity. At tolerated doses, DBDx suppressed the growth of human hepatocellular carcinoma BEL-7402, HepG2, and lung adenocarcinoma A549 xenografts by 94.5%, 93.7% and 96.9%, respectively. Clonogenic assay demonstrated that DBDx showed weak cytotoxicity. Western blot showed that Flk1 and Nos3 were down-regulated in the DBDx-treated group. Proteomic analysis showed that DBDx mainly affected the metabolic process and immune system process; in addition, the angiogenesis and VEGF signaling pathway were also affected. Conclusively, DBDx, a multifunctional drug combination of three low-cytotoxic drugs, shows synergistic and highly potent antitumor efficacy evidently mediated by the modulation of tumor microenvironment. Based on its low-cytotoxic attributes and its broad-spectrum antitumor therapeutic efficacy, this multifunctional combination might be useful in the treatment of cancers, especially those refractory to conventional chemotherapeutics.

  4. Predicting in vivo anti-hepatofibrotic drug efficacy based on in vitro high-content analysis.

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    Baixue Zheng

    Full Text Available BACKGROUND/AIMS: Many anti-fibrotic drugs with high in vitro efficacies fail to produce significant effects in vivo. The aim of this work is to use a statistical approach to design a numerical predictor that correlates better with in vivo outcomes. METHODS: High-content analysis (HCA was performed with 49 drugs on hepatic stellate cells (HSCs LX-2 stained with 10 fibrotic markers. ~0.3 billion feature values from all cells in >150,000 images were quantified to reflect the drug effects. A systematic literature search on the in vivo effects of all 49 drugs on hepatofibrotic rats yields 28 papers with histological scores. The in vivo and in vitro datasets were used to compute a single efficacy predictor (E(predict. RESULTS: We used in vivo data from one context (CCl(4 rats with drug treatments to optimize the computation of E(predict. This optimized relationship was independently validated using in vivo data from two different contexts (treatment of DMN rats and prevention of CCl(4 induction. A linear in vitro-in vivo correlation was consistently observed in all the three contexts. We used E(predict values to cluster drugs according to efficacy; and found that high-efficacy drugs tended to target proliferation, apoptosis and contractility of HSCs. CONCLUSIONS: The E(predict statistic, based on a prioritized combination of in vitro features, provides a better correlation between in vitro and in vivo drug response than any of the traditional in vitro markers considered.

  5. Acamprosate for treatment of alcohol dependence: mechanisms, efficacy, and clinical utility

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    Witkiewitz K

    2012-02-01

    Full Text Available Katie Witkiewitz, Kimber Saville, Kacie HamreusDepartment of Psychology, Washington State University Vancouver, Vancouver, WA, USAAbstract: Acamprosate, or N-acetyl homotaurine, is an N-methyl-D-aspartate receptor modulator approved by the Food and Drug Administration (FDA as a pharmacological treatment for alcohol dependence. The exact mechanism of action of acamprosate is still under investigation, but the drug appears to work by promoting a balance between the excitatory and inhibitory neurotransmitters, glutamate and gamma-aminobutyric acid, respectively, and it may help individuals with alcohol dependence by reducing withdrawal-associated distress. Acamprosate has low bioavailability, but also has an excellent tolerability and safety profile. In comparison with naltrexone and disulfiram, which are the other FDA-approved treatments for alcohol dependence, acamprosate is unique in that it is not metabolized by the liver and is also not impacted by alcohol use, so can be administered to patients with hepatitis or liver disease (a common comorbid condition among individuals with alcohol dependence and to patients who continue drinking alcohol. Acamprosate has demonstrated its efficacy in more than 25 placebo-controlled, double-blind trials for individuals with alcohol dependence, and has generally been found to be more efficacious than placebo in significantly reducing the risk of returning to any drinking and increasing the cumulative duration of abstinence. However, acamprosate appears to be no more efficacious than placebo in reducing heavy drinking days. Numerous trials have found that acamprosate is not significantly more efficacious than naltrexone or disulfiram, and the efficacy of acamprosate does not appear to be improved by combining acamprosate with other active medications (eg, naltrexone or with psychosocial treatment (eg, cognitive-behavioral therapy. In this review, we present the data on acamprosate, including its pharmacology

  6. Efficacy of Acupuncture in Itch: A Systematic Review and Meta-Analysis of Clinical Randomized Controlled Trials

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    Chi Yu

    2015-01-01

    Full Text Available Background. Itch (pruritus is a sensitive state that provokes the desire to scratch. It is not only a common symptom of skin diseases but it also occurs in some systemic diseases. Clinical studies on the efficacy of the acupuncture therapy in alleviating itch are increasing, while systematic reviews assessing the efficacy of acupuncture therapy are still lacking. Objective. This systematic review aims to assess the effectiveness of acupuncture therapy for itch. Materials and Methods. A comprehensive literature search of eight databases was performed up to June 2014, and randomized controlled trials which compared acupuncture therapy and placebo acupuncture or no treatment group were identified. Accordingly, a meta-analysis was conducted. Results. This review included three articles of randomized controlled trials (RCTs from a total of 2530 articles. The results of Meta-analysis showed that acupuncture therapy was effective to alleviate itch compared with placebo acupuncture and no treatment group. Conclusion. Based on the findings of this systematic review, we cautiously suggest that acupuncture therapy could improve the clinical efficacy of itch. However, this conclusion needs more studies on various ethnic samples to confirm our final conclusion.

  7. Clinical efficacy and safety of HX575, a biosimilar recombinant human erythropoietin, in the management of anemia

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    Abraham I

    2012-09-01

    Full Text Available Ivo Abraham,1,2,3 Karen MacDonald21Department of Pharmacy Practice and Science, and Center for Health Outcomes and PharmoEconomic Research, University of Arizona, Tucson, Arizona; 2Department of Family and Community Medicine, University of Arizona, Tucson, Arizona; 3Matrix45, Tucson, Arizona, USAAbstract: Since the expiration of the patent for epoetin alfa in Europe in 2004, the European Medicines Agency has approved three biosimilar erythropoietins. Using the European Medicines Agency’s European Public Assessment Reports and scientific publications, we review the evidence regarding the clinical efficacy and safety of HX575 (Sandoz/Novartis relative to the originator product Eprex/Erypo (Johnson & Johnson. Clinical efficacy is assessed as a function of therapeutic equivalence of a biosimilar and originator product, while safety is evaluated in terms of immunogenicity, venous thromboembolism, and mortality. Five studies that examined chronic renal failure and oncology populations are reviewed. In the renal setting, these studies include a randomized controlled trial on Hb maintenance in patients receiving long-term hemodialysis, a randomized safety trial in patients with chronic kidney disease not yet requiring renal replacement therapy, and a post-approval saftey commitment study. Studies in the cancer setting include a clinical validation study in patients with solid tumors receiving antineoplastic chemotherapy and a retrospective clinical audit of Binocrit in routine clinical practice. Based on available therapeutic equivalence and safety data, the clinical and safety outcomes of treatment with HX575 are likely to be similar to those of the originator product Eprex/Erypo. Both products can be considered interchangeable in the management of anemia in the approved indications, and patients transferred from the reference product to the biosimilar product are expected to show the same efficacy and safety outcomes. There is no evidence of the

  8. Microleakage, adaptation ability and clinical efficacy of two fluoride releasing fissure sealants

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    Marković Dejan

    2012-01-01

    Full Text Available Background/Aim. Retention of fissure sealants and good adaptation to enamel are essential for their success. Fluoride releasing resin-based materials are widely accepted for pit and fissure sealing, but newly designed glass ionomers can serve as a good alternative. The aim of this study was to evaluate microleakage and sealing ability in vitro, and to clinically assess two fluoride releasing fissure sealants. Methods. The sample for experimental study consisted of 20 freshly extracted intact human third molars, divided in two experimental groups according to the sealing material: fluoride releasing resin-based (Heliosel F and glass ionomer (Fuji Triage material. Digital images and scanning electron microscope were used to assess microleakage and adaptation ability. Sample for clinical study consisted of 60 children, aged 6-8 years, with high caries risk, divided in two groups according to the sealant material. Fissure sealant was applied to all erupted, caries-free first permanent molars. Sealants were evaluated after 3, 6 and 12 months using modified Ryge criteria for retention, marginal adaptation, colour match, surface smoothness and caries. Results. Microleakage was detected in more than half of the specimen, without significant differences between the two groups (p > 0.05. Both materials exhibited acceptable sealing ability. Complete retention at the end of the observation period was 81.8% for resin-based, and 21.1% for glass-ionomer fissure sealant (p < 0.001. The presence of caries in sealed molars has been detected in one patient in both groups. During the 12-month observation period, Helioseal F demonstrated better retention, marginal adaptation and surface smoothness (p < 0.001. There were no differences between the two materials regarding caries and color match (p > 0.05. Conclusion. Both tested materials demonstrate satisfactory clinical and caries prophylactic characteristics that justify their use in contemporary preventive

  9. The Cannabis Dilemma: A Review of Its Associated Risks and Clinical Efficacy

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    Melvyn Weibin Zhang

    2015-01-01

    Full Text Available Cannabis, also known as marijuana, has 9-tetrahydrocannabinol as the main constituent. There has been strict legislation governing the utilization of cannabis locally and worldwide. However, there has been an increasing push to make cannabis legalized, in view of its potential medical and therapeutic effects, for various medical disorders ranging from development disorders to cancer treatment, and being an adjunctive medication for various neurological conditions. It is the aim of this review paper to explore the evidence base for its proposed therapeutic efficacy and to compare the evidence base supporting its proposed therapeutic efficacy with its known and well-researched medical and psychiatric side effects.

  10. Significance of Evidence-based Medicine in the Assessment of Chinese Medicine Clinical Efficacy

    Institute of Scientific and Technical Information of China (English)

    WANG Ji-yao

    2010-01-01

    @@ Evidence-based medicine (EBM) requires the integration of the best research evidence with our clinical expertise and our patient's unique values and circumstances.The best evidence is valid and clinically relevant,especially from patient-centered clinical research.The clinical expertise means the ability to use our clinical skills and past experiences to rapidly identify each patient's unique health state and diagnosis,their individual risks,and the benefits of interventions (1)..

  11. Efficacy of brief interventions in clinical care settings for persons living with HIV.

    Science.gov (United States)

    Lightfoot, Marguerita; Rotheram-Borus, Mary Jane; Comulada, W Scott; Reddy, Vanessa S; Duan, Naihua

    2010-03-01

    Prevention of HIV transmission from patients living with HIV (PLH) is a high national priority and strategies that are easy to implement and sustain to eliminate sexual transmission acts among PLH are needed. We evaluated a brief intervention that focused primarily on the enhancing motivations and encouraging PLH to act in accordance with their values without providing the intensity of the existing evidence-based programs for PLH. Using a quasiexperimental design, six medical clinics in Los Angeles County, CA, were evaluated across three intervention conditions: 1) computerized delivery; 2) provider delivery; or 3) standard care. We examined longitudinal changes in patients' reports of the number of HIV-negative (HIV-) or serostatus-unknown sexual partners and the number of unprotected vaginal and anal sex acts. Among 566 PLH, PLH in the computerized delivery condition reported a significant decrease in the number of HIV-/unknown sexual partners compared with the provider delivery and standard care conditions and a significant decrease in the number of unprotected sex acts in comparison to the standard care condition. Computerized motivational interventions delivered in waiting rooms at medical clinics may be an efficient strategy to reduce unprotected sex acts among PLH.

  12. Investigation of critical inter-related factors affecting the efficacy of pulsed light for inactivating clinically relevant bacterial pathogens.

    Science.gov (United States)

    Farrell, H P; Garvey, M; Cormican, M; Laffey, J G; Rowan, N J

    2010-05-01

    To investigate critical electrical and biological factors governing the efficacy of pulsed light (PL) for the in vitro inactivation of bacteria isolated from the clinical environment. Development of this alternative PL decontamination approach is timely, as the incidence of health care-related infections remains unacceptably high. Predetermined cell numbers of clinically relevant Gram-positive and Gram-negative bacteria were inoculated separately on agar plates and were flashed with pulses of broad-spectrum light under varying operating conditions, and their inactivation measured. Significant differences in inactivation largely occurred depending on the level of the applied lamp discharge energy (range 3.2-20 J per pulse), the amount of pulsing applied (range 0-60 pulses) and the distance between light source and treatment surface (range 8-20 cm) used. Greater decontamination levels were achieved using a combination of higher lamp discharge energies, increased number of pulses and shorter distances between treatment surface and the xenon light source. Levels of microbial sensitivity also varied depending on the population type, size and age of cultures treated. Production of pigment pyocynanin and alginate slime in mucoid strains of Pseudomonas aeruginosa afforded some protection against lethal action of PL; however, this was evident only by using a combination of reduced amount of pulsing at the lower lamp discharge energies tested. A clear pattern was observed where Gram-positive bacterial pathogens were more resistant to cidal effects of PL compared to Gram negatives. While negligible photoreactivation of PL-treated bacterial strains occurred after full pulsing regimes at the different lamp discharge energies tested, some repair was evident when using a combination of reduced pulsing at the lower lamp discharge energies. Strains harbouring genes for multiple resistances to antibiotics were not significantly more resistant to PL treatments. Slight temperature

  13. [Efficacy of early combined high-dose steroid + PGE1 treatment for sudden deafness].

    Science.gov (United States)

    Kubota, Toshinori; Watanabe, Tomoo; Yokota, Masashi; Ito, Tsukasa; Aoyagi, Masaru

    2012-05-01

    The efficacy of combined high-dose steroid and PGE1 treatment initiated immediately after the onset of sudden deafness was analyzed with the outcome of 174 patients begun on treatment within 7 days of the onset of sudden deafness. Four potential prognostic factors (days from onset to treatment, age, initial hearing level, presence of vertigo) and hearing outcome were examined with a multiple logistic regression analysis. Days from onset to treatment and age significantly correlated with hearing improvement. The efficacy of the treatment of patients begun on treatment within 3 days of the onset was significantly better than that of patients on treatment 4-7 days after the onset (p sudden deafness, and started within 3 days of the onset of sudden deafness in patients 50 years old and older.

  14. A survey of diet self-efficacy and food intake in students with high and low perceived stress.

    Science.gov (United States)

    Nastaskin, Robyn S; Fiocco, Alexandra J

    2015-04-23

    Given the rise in obesity and obesity-related disorders, understanding the relationship between stress, self-efficacy and food choice in young adulthood may have implications for preventing negative health outcomes later in life that stem from poor eating habits. The current study examined whether stress levels and diet self-efficacy may be associated with unhealthy eating habits in young adults. Male and female undergraduate students (N = 136) completed questionnaires that tap into diet self-efficacy (DSE), perceived stress (PS), sodium, and fat intake. Sex differences in choice of food were predicted, and low levels of perceived stress and high diet self-efficacy were expected to be associated with lower fat and sodium intake. Findings indicate an interaction between perceived stress and diet self-efficacy on fat intake and a main effect for diet self-efficacy on sodium intake in this population. As expected, low levels of perceived stress and high diet self-efficacy were associated with the lowest levels of fat and sodium intake in students. Findings were driven by females. This study provides preliminary evidence that diet self-efficacy and perceived stress levels relate to nutrient intake in young adult females, and that increasing diet self-efficacy and reducing perceived stress in young adult females may lead to reductions in fat and sodium intake, leading to healthier eating habits.

  15. Mathematics: Self-Efficacy, Identity, and Achievement among African American Males from the High School Longitudinal Study

    Science.gov (United States)

    Briggs, Calvin

    2014-01-01

    The purpose of this study was to determine if a relationship existed between mathematics self-efficacy and mathematics identity to mathematics achievement among African American males from High School Longitudinal Study of 2009 (HSLS:09). Subsequently, the extent to which mathematics self-efficacy and mathematics identity accounted for low and…

  16. Influence of maternal immunity on vaccine efficacy and susceptibility of commercial broilers against highly pathogenic avian influenza virus

    Science.gov (United States)

    Maternal antibodies provide early protection from disease, but may interfere with the vaccination efficacy in short-lived broilers. This study seeks to assess how maternal immunity can interfere with vaccine efficacy against clade 2.3.4.4 H5N2 highly pathogenic avian influenza virus (HPAIV) and how ...

  17. CLINICAL AND PHARMACOECONOMIC EFFICACY OF NATIONAL LACTOBACILLUS-BASED PROBIOTICS IN COMPLEX THERAPY FOR ACUTE ENTERIC INFECTIONS IN CHILDREN

    Directory of Open Access Journals (Sweden)

    N.V. Gonchar

    2010-01-01

    Full Text Available Active use of probiotic medications in children with acute enteric infections (AEI does not always result in noticeable improvement of therapy results, which triggers the need for a study of pharmacoeconomic efficacy of using probiotics. The results of complex therapy for AEI in infants using lactobacillus-based prebiotics and conventional therapy were compared. Key clinical criteria of therapy for AEI were: reduction in inflammatory intestine modifications, elimination of Klebsiella pneumoniae, restoration of indigenous microflora. The results of the conducted study helped identify antagonism of Vitaflora against K. pneumoniae, a positive influence on colitis syndrome progress, as well as identify Biobacton’s impact on the restoration of intestine microbiocenosis.Key words: Acute enteric infections, children, infancy, therapy, prebiotics, pharmacoeconomic efficacy. (Pediatric Pharmacology. – 2010; 7(6:10-15

  18. Clinical comparison between the bleaching efficacy of light-emitting diode and diode laser with sodium perborate.

    Science.gov (United States)

    Koçak, Sibel; Koçak, Mustafa Murat; Sağlam, Baran Can

    2014-04-01

    The aim of this clinical study was to test the efficacy of a light-emitting diode (LED) light and a diode laser, when bleaching with sodium perborate. Thirty volunteers were selected to participate in the study. The patients were randomly divided into two groups. The initial colour of each tooth to be bleached was quantified with a spectrophotometer. In group A, sodium perborate and distilled water were mixed and placed into the pulp chamber, and the LED light was source applied. In group B, the same mixture was used, and the 810 nm diode laser was applied. The final colour of each tooth was quantified with the same spectrophotometer. Initial and final spectrophotometer values were recorded. Mann-Whitney U-test and Wicoxon tests were used to test differences between both groups. Both devices successfully whitened the teeth. No statistical difference was found between the efficacy of the LED light and the diode laser.

  19. A comparison of the efficacy of powered and manual toothbrushes in controlling plaque and gingivitis: a clinical study

    Directory of Open Access Journals (Sweden)

    Jain Y

    2013-02-01

    Full Text Available Yashika JainDepartment of Periodontology and Implantology, SGT Dental College and Research Institute, Gurgaon (Haryana, IndiaBackground: Plaque is intimately related to the production and progress of dental caries and inflammatory gingival and periodontal diseases. Good plaque control facilitates the return to health for patients with gingival and periodontal diseases. Daily use of a toothbrush and other oral hygiene aids is the most dependable way to achieve oral health benefits for all patients.Methods: A randomized clinical trial was conducted to compare the efficacy of a powered toothbrush with a manual toothbrush in controlling plaque and gingivitis over a 6-week period. The sample consisted of 60 dental students of both sexes, with ages ranging from 18 to 28 years. The samples were stratified and randomly divided into two groups of 30 by a second examiner using the coin toss method; one group used a manual toothbrush and the other group used a powered toothbrush. Each participant’s gingival index, plaque index and oral hygiene index were assessed on the seventh, 14th, and 45th days on the basis of the assigned toothbrush. Collected data were analyzed and different subgroups were compared using Student’s t-test.Results: A paired t-test revealed a highly significant reduction in the gingival, plaque, and oral hygiene index scores of the manual and powered groups at the first, second, and sixth weeks (P-value < 0.0001. An unpaired t-test revealed a significant reduction between the plaque index scores of the manual and powered groups at the second week (P-value < 0.05. Another unpaired t-test revealed a highly significant reduction between the plaque index scores of the manual and powered groups at the sixth week (P-value < 0.0001.Conclusion: The subject group using the powered toothbrush demonstrated clinical and statistical improvement in overall plaque scores. Powered toothbrushes offer an individual the ability to brush the teeth in a

  20. Predicting In Vivo Anti-Hepatofibrotic Drug Efficacy Based on In Vitro High-Content Analysis

    OpenAIRE

    2011-01-01

    BACKGROUND/AIMS: Many anti-fibrotic drugs with high in vitro efficacies fail to produce significant effects in vivo. The aim of this work is to use a statistical approach to design a numerical predictor that correlates better with in vivo outcomes. METHODS: High-content analysis (HCA) was performed with 49 drugs on hepatic stellate cells (HSCs) LX-2 stained with 10 fibrotic markers. ~0.3 billion feature values from all cells in >150,000 images were quantified to reflect the drug effects. A sy...

  1. Treatment of cerebral palsy children by integrative medical sequential method:a clinical efficacy observation

    Institute of Scientific and Technical Information of China (English)

    王丽芳

    2014-01-01

    Objective To observe the efficacy of integrative medical sequential method in treating cerebral palsy(CP)children’s intelligence development,muscular tension,serum interleukin 6(IL-6),and tumor necrosisfactorα(TNF-α).Methods Totally 111 CP children were randomly assigned to the control group(50 cases)and the treatment group(61 cases).All patients received

  2. Efficacy of strategy training in left hemisphere stroke patients with apraxia : A randomised clinical trial

    NARCIS (Netherlands)

    Donkervoort, M; Dekker, J; Stehmann-Saris, FC; Deellman, BG

    2001-01-01

    The objective of the present study was to determine in a controlled study the efficacy of strategy training in left hemisphere stroke patients with apraxia. A total of 113 left hemisphere stroke patients with apraxia were randomly assigned to two treatment groups; (1) strategy training integrated in

  3. Efficacy of strategy training in left hemisphere stroke patients with apraxia: a randomised clinical trial.

    NARCIS (Netherlands)

    Donkervoort, M.; Dekker, J.; Stehmann-Saris, F.C.; Deelman, B.G.

    2001-01-01

    The objective of the present study was to determine in a controlled study the efficacy of strategy training in left hemisphere stroke patients with apraxia. A total of 113 left hemisphere stroke patients with apraxia were randomly assigned to two treatment groups; (1) strategy training integrated in

  4. Efficacy of strategy training in left hemisphere stroke patients with apraxia: a randomized clinical trial.

    NARCIS (Netherlands)

    Dekker, J.; Donkervoort, M.; Stehman, F.C.; Deelman, B.G.

    2001-01-01

    The objective of the present study was to determine in a controlled study the efficacy of strategy training in left hemisphere stroke patients with apraxia. 113 Left hemisphere assigned to two treatment groups: i) strategy training integrated into usual occupational therapy and ii) usual occupationa

  5. Efficacy of a trauma-focused treatment approach for dental phobia: a randomized clinical trial

    NARCIS (Netherlands)

    Doering, S.; Ohlmeier, M.C.; de Jongh, A.; Hofmann, A.; Bisping, V.

    2013-01-01

    It has been hypothesized that treatment specifically focused on resolving memories of negative dental events might be efficacious for the alleviation of anxiety in patients with dental phobia. Thirty-one medication-free patients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-

  6. Efficacy of strategy training in left hemisphere stroke patients with apraxia : A randomised clinical trial

    NARCIS (Netherlands)

    Donkervoort, M; Dekker, J; Stehmann-Saris, FC; Deellman, BG

    2001-01-01

    The objective of the present study was to determine in a controlled study the efficacy of strategy training in left hemisphere stroke patients with apraxia. A total of 113 left hemisphere stroke patients with apraxia were randomly assigned to two treatment groups; (1) strategy training integrated

  7. Clinical Efficacy and Safety of Liquid Pelargonium sidoides Preparation (EPs 7630 in Children with Acute Non-Streptococcal Tonsillopharyngitis

    Directory of Open Access Journals (Sweden)

    V. Berezhnoi

    2016-11-01

    Full Text Available Background Acute tonsillopharyngitis is amongst the most common reasons for children, adolescents and young adults to consult with a physician. Despite extensive prescription, antibiotic therapy is indicated in less than one-fifth of these cases. New treatment strategies for patients with non-group-A-streptococcal acute tonsillopharyngitis are therefore required. Objectives EPs 7630 is an extract from the roots of Pelargonium sidoides DC. After positive clinical study results in children with acute bronchitis, the present study was conducted to demonstrate the efficacy of EPs 7630 in the treatment of acute tonsillopharyngitis in children. Methods In this double-blind placebo-controlled clinical trial with a group sequential design, the efficacy and tolerability of EPs 7630 were investigated in 6- to 10-year-old patients with acute tonsillopharyngitis, who showed no evidence of group A β-hemolytic streptococcus. Treatment duration was 6 days. Primary efficacy variable was change in the sum score of the tonsillitis severity score (TSS on day 4 compared to baseline. Results Overall, data on the change of the TSS measured for the EPs 7630 and placebo group were available for 60 and 64 children, respectively. After 4 days of treatment, the TSS had decreased from 9.6 ± 1.2 to 2.8 ± 2.6 points in the active medication group and from 9.5 ± 1.3 to 6.1 ± 4.1 points in the placebo group (P < 0.001, indicating superiority of EPs 7630 over placebo. Conclusions EPs 7630 was found to be efficacious in the treatment of acute tonsillopharyngitis in children and was very well tolerated.

  8. Evaluation of the Clinical Efficacy of Qingqiao Capsule (清窍胶囊) in Treating Patients with Secretory Otitis Media

    Institute of Scientific and Technical Information of China (English)

    SUN Yong-dong; CHEN Long-hui; HU Wen-jian; JIANG Yu-liang; CHEN Xiao-lin; ZHANG Shi-bo

    2005-01-01

    Objective: To ooserve the clinical efficacy of Qingqiao Capsule (清窍胶囊, QQC) in treating patients with secretory otitis media (SOM). Methods: A total of 90 patients were randomly assigned into the treated group (n=45 ) and the control group (n =45). Patients in the treated group were administrated with QQC, 5 capsules each time, 3 times a day for totally 10-14 days, and those in the control group were given per os cefaclor capsules 0.5g each time for adult, 3 times a day, or 20mg/(kg· d) for children, for 10-14 days. The therapeutic efficacy of treatment on the patients was observed and compared after treatment and followed up for 3-6 months. Results: (1) The clinical efficacy in the treated group was superior to that in the control group with significant statistical difference ( P<0.01 ); (2) Comparison of the efficacies in patients of three different TCM syndrome types (the external pathogenic wind invasion caused auditory orifice stuffiness type, the Gan-Dan damp-heat steaming up auditory orifice type and the Pi-deficiency dysfunction induced dirty dampness blocking ear type) showed no statistically significant difference(P>0.05); (3) The vanishing rate and time needed of the main symptoms and signs in the treated group were superior to those in the control group on ear muffle, tinnitus, hearing impairment, hydrotypanum, pure tone threshold and abnormal tongue figure, and the difference was statistically significant ( P<0.05 or P<0.01), only those of earache,otopiesis and abnornal pulse figure were insignificantly different between the two groups ( P>0.05). Conclusion: QQC is an effective Chinese composite medicine on patients with SOM, and shows no obvious adverse reaction.

  9. [Clinical efficacy of vitamin support in lung adenocarcinoma patients treated with pemetrexed second-line chemotherapy].

    Science.gov (United States)

    Zeng, Xiaoyuan; Zhou, Chengzhi; Ouyang, Ming; Qin, Yinyin; Yang, Hongzhong; Peng, Yiqiang; Liu, Shenggang

    2015-11-01

    To analyze the clinical efficacy and toxicity of vitamin support in lung adenocarcinoma patients treated with pemetrexed second-line chemotherapy. Two hundred and eighty-three patients with stage 3/4 lung adenocarcinoma treated at our hospital from August 2010 to August 2013 were included in this study. The lung adenocarcinomas in all the 283 patients were confirmed by pathology or cytology, all were EGFR-negative, and all patients received pemetrexed second line chemotherapy. The 283 patients were randomly divided into two groups: the improved treatment group (142 cases) and the conventional treatment group (141 cases). The patients of conventional treatment group received 400 µg folic acid per os daily for 7 days before the first dose of pemetrexed, and continued until 21 days after the last dose of pemetrexed. Besides, they received 1000 µg vitamin B12 injection at 7 days before the first dose of pemetrexed, and once per cycle of pemetrexed for 3 cycles after the last dose of pemetrexed. The patients of the improved treatment group took 400 µg folic acid daily per os from the day before the first dose to 21 days after the last dose of pemetrexed. They also received 500 µg vitamin B12 by injection one day before the first dose, and one day before each therapy cycle of pemetrexed therapy. The mean number of cycles of pemetrexed chemotherapy was 4 in both groups. In the 142 patients of improved treatment group, complete response (CR) was observed in two cases, partial remission (PR) in 28, stable disease (SD) in 21, and progressive disease (PD) in 91 cases, with a total effective rate of 21.1%. While in the conventional treatment group, CR was observed in one case, PR in 27 cases, SD in 23 cases, and PD in 90 cases, with a total effective rate of 19.9%. The median progression-free survival (PFS) was 3.8 months in the improved treatment group and 4.2 months in the conventional treatment group (P=0.143). The toxicity of chemotherapy was mild in both groups, with

  10. Thoracic bone remodeling after minimally invasive repair for pectus excavatum in adults and its clinical efficacy

    Directory of Open Access Journals (Sweden)

    Ji-fu LIU

    2012-04-01

    Full Text Available Objective To study thoracic bone remodeling after minimally invasive corrective surgery for pectus excavatum (PE in adults and ascertain its clinical efficacy. Methods A total of 82 patients aged 18 to 57 (23.5±6.1 were enrolled in this study. There were 67 male patients and 15 female patients. The symmetric type (Ⅰ type composed of 37 cases, whereas the nonsymmetric type (Ⅱ type comprised 45 cases. Haller index (HI was 3.2 to 11.8. Under general anesthesia, incisions located on looth sides of the mid-axillary line were made in all patients. The prepared supporting bar was inserted behind the sternum by videoassisted thoracoscopic monitoring (one bar for 60 patients and two bars for 22 patients. All patients were checked by chest CT scan pre-operation and 1 week post-operation to create a three-dimensional reconstruction thoracic image. In the sagittal plane, the center line of the body of the thoracic vertebrae was regarded as the incision line. The distance was measured between the sternum and the frontal edge of the body of the thoracic vertebrae. The condition of the displacement of the heart was also observed. Results When one bar was used, the middle and the inferior extremity of the mid-sternum was moved forward for 8.69 and 15.69mm, respectively, after correction. There was significant difference compared with that of the pre-operation (P < 0.01. However, the upper extremity of the mid-sternum and upper and inferior extremities of the manubrium were moved forward to 2.39, -2.38, and 1.44mm, which did not exhibit obvious difference compared with the values taken before the operation. When two bars were used for the patients, the inferior extremity of the manubrium and each of upper, middle, and inferior extremities of the mid-sternum showed a forward displacement for 10.8, 12.45, 17.61, and 20.62mm, respectively. There was significant difference compared with the pre-operative values (P < 0.001. The upper extremity of the

  11. [Ceftriaxone in neonates and young infants; clinical efficacy, pharmacokinetic evaluation and effect on intestinal bacterial flora].

    Science.gov (United States)

    Fujita, K; Murono, K; Sakata, H; Kakehashi, H; Oka, T; Kaeriyama, M; Yoshioka, H; Maruyama, S; Sanae, N; Inyaku, F

    1988-02-01

    Twenty-two newborn and young infants, including 13 premature infants, were treated with ceftriaxone (CTRX) and the clinical efficacy and side effects were evaluated. Ages of the patients ranged from 0 to 106 days, and their body weights from 1.19 to 3.92 kg. Dose levels were 15 to 23 mg/kg every 12 to 24 hours for 2 to 13.5 days. Eighteen infants with sepsis and 1 infant with purulent coxitis were considered to have responded to the CTRX treatment. The results were excellent in 13 and good in 6 patients. The drug was well tolerated, although diarrhea occurred in 2 patients, eosinophilia in 6 patients, slightly elevated serum concentrations of transaminases in 2 patients and thrombocytosis in 1 among the 22 patients. The pharmacokinetic studies on CTRX were done in 8 patients including 3 premature infants. The ages ranged from 3 to 50 days, and body weight from 2.20 to 3.94 kg. Plasma concentrations 30 minutes after single 10 mg/kg intravenous bolus injection in two 4- to 5-day-old premature neonates were 48.4 and 50.0 micrograms/ml and those at 6 hours were 22.7 and 23.4 micrograms/ml, respectively. In 2 mature neonates, plasma levels were 42.2 and 39.1 micrograms/ml at 30 minutes and 23.4 and 26.6 micrograms/ml at 6 hours after single 20 mg/kg doses. In four 12- to 50-day-old patients, plasma concentrations ranged from 35.9 to 175.0 micrograms/ml at 30 minutes and from 21.9 to 32.8 micrograms/ml at 6 hours after multiple doses of 20 mg/kg intravenous bolus injection. The plasma half-lives of the drug ranged from 6.6 to 16.8 hours in these 8 patients. Excretion rates of this drug into urine within 12 hours were 21.4 to 63.4% in 7 patients. Urine concentrations of the drug in 34 samples collected at various times from the 7 patients ranged from 28.3 to 469.0 micrograms/ml. The cerebrospinal fluid level at 2 hours after a dose was 3.33 micrograms/ml on the 5th day of treatment in 1 patient with sepsis receiving 18 mg/kg of the drug every 12 hours. Its level at 3

  12. Spectral and luminous efficacy change of high-power LEDs under different dimming methods

    Science.gov (United States)

    Gu, Yimin; Narendran, Nadarajah; Dong, Tianming; Wu, Huiying

    2006-08-01

    Dimming is an important and necessary feature for light sources used in general lighting applications. An experimental study was conducted to quantify the spectral and luminous efficacy change of high-power colored and pc-white LEDs under continuous current reduction (CCR) and pulse-width modulation (PWM) dimming schemes. For InGaN-based blue, green, and pc-white LEDs, the peak wavelength shifts were in opposite directions for the two dimming schemes. The peak wavelength showed a blue shift with increased current, most likely due to band filling and QCSE dominated effects. InGaN LEDs exhibited red shifts with increased duty cycle, which is dominated by junction heat. AlInGaP red LEDs show mainly thermal-induced red shift with increased current or duty cycle. In addition, the luminous efficacy was always higher for the CCR dimming scheme at dimmed levels, irrespective of the LED type. Keywords: Light-emitting diodes (LEDs), white LEDs, mixed-color white LEDs, pulse-width modulation (PWM), continuous current reduction (CCR), peak wavelength shift, luminous efficacy

  13. Clinical and Radiographic Assessment of the Efficacy of a Collagen Membrane in Regenerative Endodontics: A Randomized, Controlled Clinical Trial.

    Science.gov (United States)

    Jiang, Xijun; Liu, He; Peng, Chufang

    2017-09-01

    Recent reviews confirm a general lack of randomized, controlled clinical studies on the efficacy of regenerative endodontics in immature teeth affected by pulp and periapical diseases. Moreover, we have no evidence of the curative efficacy of collagen membranes used as scaffolds in regenerative endodontics. Here, we evaluated whether a Bio-Gide collagen membrane (Geistlich Pharma AG, Wolhusen, Switzerland) has efficacy in promoting dentin formation in regenerative endodontics. Forty-three patients yielding a total of 46 nonvital immature teeth were divided randomly into 2 groups. Subsequent to chemomechanical preparation, regenerative endodontics with (the experimental group) and without (the control group) Bio-Gide were performed. All cases were followed up clinically and radiographically every 3 months for at least 6 months. Quantitative analyses using an imaging program yielded percentage changes in root dimensions based on a comparison between preoperative and recall radiographs. The results of 40 patients (43 teeth) were included in the final analyses. All patients from both groups showed clinical success with complete resolution of signs and symptoms. Radiographically, the thickness of the dentin wall at the middle third of the root was higher for the experimental group than the control group. However, other indicators were comparable between both groups. The use of the Bio-Gide collagen membrane promoted the development of the dentin wall in the middle third of the root in patients undergoing regenerative endodontic procedures. The convenience of operation and the assured positioning of the sealing material make the Bio-Gide collagen membrane especially suitable for handling wide root canals. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  14. Efficacy of Selected Electrical Therapies on Chronic Low Back Pain: A Comparative Clinical Pilot Study

    Science.gov (United States)

    Rajfur, Joanna; Pasternok, Małgorzata; Rajfur, Katarzyna; Walewicz, Karolina; Fras, Beata; Bolach, Bartosz; Dymarek, Robert; Rosinczuk, Joanna; Halski, Tomasz; Taradaj, Jakub

    2017-01-01

    Background In the currently available research publications on electrical therapy of low back pain, generally no control groups or detailed randomization were used, and such studies were often conducted with relatively small groups of patients, based solely on subjective questionnaires and pain assessment scales (lacking measurement methods to objectify the therapeutic progress). The available literature also lacks a comprehensive and large-scale clinical study. The purpose of this study was to assess the effects of treating low back pain using selected electrotherapy methods. The study assesses the influence of individual electrotherapeutic treatments on reduction of pain, improvement of the range of movement in lower section of the spine, and improvement of motor functions and mobility. Material/Methods The 127 patients qualified for the therapy (ultimately, 123 patients completed the study) and assigned to 6 comparison groups: A – conventional TENS, B – acupuncture-like TENS, C – high-voltage electrical stimulation, D – interferential current stimulation, E – diadynamic current, and F – control group. Results The research showed that using electrical stimulation with interferential current penetrating deeper into the tissues results in a significant and more efficient elimination of pain, and an improvement of functional ability of patients suffering from low back pain on the basis of an analysis of both subjective and objective parameters. The TENS currents and high voltage were helpful, but not as effective. The use of diadynamic currents appears to be useless. Conclusions Selected electrical therapies (interferential current, TENS, and high voltage) appear to be effective in treating chronic low back pain. PMID:28062862

  15. Building Self-Efficacy for Exercise among Rural High School Students: It Takes Ongoing Practice

    Science.gov (United States)

    Hortz, Brian; Petosa, R. Lingyak; Grim, Melissa L.; Stevens, Emily

    2015-01-01

    Background: Self-efficacy has been associated with adolescent exercise. Previous studies have revealed that self-efficacy is relatively resistant to change. Effective strategies to build self-efficacy among adolescents are needed. Purpose: To describe the changes in self-efficacy and leisure time exercise produced by the "Planning to be…

  16. “即查即治”处理宫颈高度鳞状上皮内病变的临床价值%Clinical efficacy of “see-and-treat”strategy in the management of high-grade squamous intraepithelial lesion

    Institute of Scientific and Technical Information of China (English)

    谭露; 储丽萍; 邓继红; 安红梅; 马丽莎

    2014-01-01

    目的:探讨“即查即治”方法对宫颈细胞学为高度鳞状上皮内病变(high-grade squamous intraepithelial le-sion, HSIL)妇女的诊治价值,为临床提供有价值的诊疗手段。方法:收集2010年1月-2013年1月,年龄25~83岁,宫颈细胞学筛查为HSIL的妇女200例,按随机化的方法分为实验组(即查即治)和对照组(传统三阶梯诊断程序方法)。比较两组的宫颈电环切术后并发症发生率及最终病理结果。结果:实验组与对照组在宫颈电环切术后并发症发生率差异无统计学意义(P>0.05)。实验组宫颈上皮内瘤样病变(cervical intraepithelial neoplasia,CIN)病理符合率98%(98/100),对照组为97%(97/100),以病理结果≤CIN 1作为过度治疗评判标准,实验组和对照组过度治疗率分别为9%(9/100)、11%(11/100),两组病理结果及过度治疗率差异无统计学意义(P>0.05)。结论:“即查即治”策略处理宫颈细胞学为HSIL是安全、经济和有效的诊疗手段。%Objective: To investigate the safety and efficacy of see-and-treat strategy in the management of high-grade squamous intraepithelial lesion(HSIL),so that to provide a valuable diagnosis and treatment method for HSIL. Methods: 200 non-pregnant women,aged 22-63 years old, recruited as HSIL from January 2010 to January 2013 were randomized into 2 groups:A see-and-treat strategy group,B traditional method of three steps group. The therapeutic efficacy and over-treatment rate of 2 groups were evaluated and compared. Results: There was no significant difference in postoperative complications in the LEEP and colposcopy score between two groups (P>0.05). Histological diagnosis of cervical intraepithelial neoplasia(CIN) was confirmed in 98%(98/100) patients in see & treat group and 97%(97/100) in control group (P>0.05). Using histological diagnosis≤CIN 1 as overtreatment, the overtreatment rate was 9%(9/100) and 11%(11/100) in “see-and-treat” group

  17. Advances in stent technologies and their effect on clinical efficacy and safety

    Directory of Open Access Journals (Sweden)

    Nikam N

    2014-06-01

    Full Text Available Navin Nikam, Toby B Steinberg, Daniel H SteinbergDivision of Cardiology, Medical University of South Carolina, Charleston, SC, USAAbstract: The introduction of intracoronary stents represented a major advance in interventional cardiology. While bare metal stents set the benchmark for improved safety over angioplasty, intimal hyperplasia and subsequent restenosis were important limitations. First-generation drug-eluting stents demonstrated significant improvements in efficacy, but not necessarily safety, and further technologic developments have focused on optimizing both. Current advances and understanding in stent design continue to improve on these concepts. This review summarizes past and present technology with particular emphasis on the principles underlying the efficacy and safety of drug-eluting stents, and offers a glimpse into the next generations of stents aimed at treating symptomatic coronary artery disease.Keywords: drug-eluting stents percutaneous coronary intervention, coronary artery disease, bioabsorbable polymers, bioabsorbable struts, polymer free

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

    Science.gov (United States)

    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%.

  19. Efficacy of 8- and 4-Session Mindfulness-Based Interventions in a Non-clinical Population: A Controlled Study

    Science.gov (United States)

    Demarzo, Marcelo; Montero-Marin, Jesus; Puebla-Guedea, Marta; Navarro-Gil, Mayte; Herrera-Mercadal, Paola; Moreno-González, Sergio; Calvo-Carrión, Sandra; Bafaluy-Franch, Laura; Garcia-Campayo, Javier

    2017-01-01

    Background: Many attempts have been made to abbreviate mindfulness programmes in order to make them more accessible for general and clinical populations while maintaining their therapeutic components and efficacy. The aim of this study was to assess the efficacy of an 8-week mindfulness-based intervention (MBI) programme and a 4-week abbreviated version for the improvement of well-being in a non-clinical population. Method: A quasi-experimental, controlled, pilot study was conducted with pre-post and 6-month follow-up measurements and three study conditions (8- and 4-session MBI programmes and a matched no-treatment control group, with a sample of 48, 46, and 47 participants in each condition, respectively). Undergraduate students were recruited, and mindfulness, positive and negative affect, self-compassion, resilience, anxiety, and depression were assessed. Mixed-effects multi-level analyses for repeated measures were performed. Results: The intervention groups showed significant improvements compared to controls in mindfulness and positive affect at the 2- and 6-month follow-ups, with no differences between 8- vs. 4-session programmes. The only difference between the abbreviated MBI vs. the standard MBI was found in self-kindness at 6 months, favoring the standard MBI. There were marginal differences in anxiety between the controls vs. the abbreviated MBI, but there were differences between the controls vs. the standard MBI at 2- and 6-months, with higher levels in the controls. There were no differences in depression between the controls vs. the abbreviated MBI, but differences were found between the controls vs. the standard MBI at 2- and 6-months, favoring the standard MBI. There were no differences with regard to negative affect and resilience. Conclusion: To our knowledge, this is the first study to directly investigate the efficacy of a standard 8-week MBI and a 4-week abbreviated protocol in the same population. Based on our findings, both programmes

  20. CLINICAL EVALUATION OF EFFICACY AND SAFETY OF DEXMEDETOMEDINE AS AN ADJUNCT TO CAUDAL ROPIVACAINE IN PEDIATRIC INFRAUMBILICAL SURGERIES

    Directory of Open Access Journals (Sweden)

    Urmila

    2014-05-01

    Full Text Available BACKGROUND: Caudal epidural is one of the most popular reliable & safe technique mainly used for intra and post-op analgesia in pediatric patients undergoing infra umbilical surgeries. To prolong the duration of analgesia various adjuvants like epinephrine, opioids, ketamine, midazolam, tramadol, clonidine, were added to local anesthetic. The aim of this study was to evaluate the clinical efficacy and safety of CAUDAL administration of plain Ropivacaine 0.2% (1miligram/kilogram body weight with and without dexmedetomedine (2 microgram/kilogram body weight in children undergoing infraumbilical surgeries; in terms of quality of surgical anesthesia and the duration of post-operative analgesia.

  1. Efficacy of 8- and 4-Session Mindfulness-Based Interventions in a Non-clinical Population: A Controlled Study.

    Science.gov (United States)

    Demarzo, Marcelo; Montero-Marin, Jesus; Puebla-Guedea, Marta; Navarro-Gil, Mayte; Herrera-Mercadal, Paola; Moreno-González, Sergio; Calvo-Carrión, Sandra; Bafaluy-Franch, Laura; Garcia-Campayo, Javier

    2017-01-01

    Background: Many attempts have been made to abbreviate mindfulness programmes in order to make them more accessible for general and clinical populations while maintaining their therapeutic components and efficacy. The aim of this study was to assess the efficacy of an 8-week mindfulness-based intervention (MBI) programme and a 4-week abbreviated version for the improvement of well-being in a non-clinical population. Method: A quasi-experimental, controlled, pilot study was conducted with pre-post and 6-month follow-up measurements and three study conditions (8- and 4-session MBI programmes and a matched no-treatment control group, with a sample of 48, 46, and 47 participants in each condition, respectively). Undergraduate students were recruited, and mindfulness, positive and negative affect, self-compassion, resilience, anxiety, and depression were assessed. Mixed-effects multi-level analyses for repeated measures were performed. Results: The intervention groups showed significant improvements compared to controls in mindfulness and positive affect at the 2- and 6-month follow-ups, with no differences between 8- vs. 4-session programmes. The only difference between the abbreviated MBI vs. the standard MBI was found in self-kindness at 6 months, favoring the standard MBI. There were marginal differences in anxiety between the controls vs. the abbreviated MBI, but there were differences between the controls vs. the standard MBI at 2- and 6-months, with higher levels in the controls. There were no differences in depression between the controls vs. the abbreviated MBI, but differences were found between the controls vs. the standard MBI at 2- and 6-months, favoring the standard MBI. There were no differences with regard to negative affect and resilience. Conclusion: To our knowledge, this is the first study to directly investigate the efficacy of a standard 8-week MBI and a 4-week abbreviated protocol in the same population. Based on our findings, both programmes

  2. Efficacy of afoxolaner in a clinical field study in dogs naturally infested with Sarcoptes scabiei

    Directory of Open Access Journals (Sweden)

    Beugnet Frédéric

    2016-01-01

    Full Text Available The acaricidal efficacy of afoxolaner (NexGard®, Merial was evaluated against Sarcoptes scabiei var. canis in a field efficacy study, when administered orally at a minimum dose of 2.5 mg/kg to dogs naturally infested with the mites. Twenty mixed-breed dogs of either sex (6 males and 14 females, aged over 6 months and weighing 4–18 kg, were studied in this randomised controlled field efficacy trial. Dogs, naturally infested with Sarcoptes scabiei var. canis confirmed by skin scrapings collected prior to allocation, were randomly divided into two equal groups. Dogs in Group 1 were not treated. Dogs in Group 2 were treated on Days 0 and 28. On Days 0 (pre-treatment, 28 (pre-treatment and 56, five skin scrapings of similar size were taken from different sites with lesions suggestive of sarcoptic mange. The extent of lesions was also recorded on Days 0, 28 and 56, and photographs were taken. Dogs treated orally with afoxolaner had significantly (p < 0.001 lower mite counts than untreated control animals at Days 28 and 56 with no mites recovered from treated dogs at these times (100% efficacy based on mite counts. In addition, dogs treated with NexGard had significantly (p < 0.05 better lesion resolution at Day 56 than Day 0; no treated dog showed pruritus compared to 7/10 dogs in the control group, 1/9 treated dogs had crusts compared to 5/10 controls and 8/9 dogs recovered 90% of hairs on lesions compared to 0/10 control dogs.

  3. Efficacy of afoxolaner in a clinical field study in dogs naturally infested with Sarcoptes scabiei.

    Science.gov (United States)

    Beugnet, Frédéric; de Vos, Christa; Liebenberg, Julian; Halos, Lénaïg; Larsen, Diane; Fourie, Josephus

    2016-01-01

    The acaricidal efficacy of afoxolaner (NexGard(®), Merial) was evaluated against Sarcoptes scabiei var. canis in a field efficacy study, when administered orally at a minimum dose of 2.5 mg/kg to dogs naturally infested with the mites. Twenty mixed-breed dogs of either sex (6 males and 14 females), aged over 6 months and weighing 4-18 kg, were studied in this randomised controlled field efficacy trial. Dogs, naturally infested with Sarcoptes scabiei var. canis confirmed by skin scrapings collected prior to allocation, were randomly divided into two equal groups. Dogs in Group 1 were not treated. Dogs in Group 2 were treated on Days 0 and 28. On Days 0 (pre-treatment), 28 (pre-treatment) and 56, five skin scrapings of similar size were taken from different sites with lesions suggestive of sarcoptic mange. The extent of lesions was also recorded on Days 0, 28 and 56, and photographs were taken. Dogs treated orally with afoxolaner had significantly (p < 0.001) lower mite counts than untreated control animals at Days 28 and 56 with no mites recovered from treated dogs at these times (100% efficacy based on mite counts). In addition, dogs treated with NexGard had significantly (p < 0.05) better lesion resolution at Day 56 than Day 0; no treated dog showed pruritus compared to 7/10 dogs in the control group, 1/9 treated dogs had crusts compared to 5/10 controls and 8/9 dogs recovered 90% of hairs on lesions compared to 0/10 control dogs.

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

    DEFF Research Database (Denmark)

    Nørgaard, Birgitte; Draborg, Eva; Vestergaard, Erik

    2013-01-01

    and competences to engage in fruitful interprofessional teamwork. The aim of this study was to assess the impact of an interprofessional training program on students’ self-efficacy in interprofessional collaboration. Methods: The study was designed as a quasi-experiment with an intervention group (239 students......Background: Interprofessional collaboration potentially enhances patient safety and satisfaction, and reduces tensions and conflicts among health care professionals. Such collaboration is challenging, however, because health care professionals lack sufficient knowledge of other professional roles...

  5. A clinical study of the efficacy of topical corticosteroids on dry eye

    OpenAIRE

    Yang, Chong-qing; Sun, Wen; Gu, Yang-Shun

    2006-01-01

    Objective: To evaluate the effect of topical corticosteroid for treatment of moderate or severe dry eye. Methods: Sixty eyes of 30 patients with moderate or severe dry eye, who were not sensitive to artificial tears, were treated with 0.1% fluorometholone eye drops. Subjective symptom and objective tests were used to evaluate the efficacy of treatment before and after application of 0.1% fluorometholone eye drops for 1 week and 1 month. Side effects were also evaluated. Results: After 1 week ...

  6. Efficacy and toxicity differences in lung cancer populations in the era of clinical trials globalization: the 'common arm' approach.

    Science.gov (United States)

    Mack, Philip C; Gandara, David R; Lara, Primo N

    2012-12-01

    Historically, notable variability has been observed in clinical trial outcomes between different regions and populations worldwide, even when employing the same cytotoxic regimen in lung cancer. These divergent results underscore the inherent challenges in interpreting trials conducted abroad and raise questions regarding the general applicability of transnational clinical trials. Various reasons have been postulated to account for these differences in efficacy and toxicity, including trial design, eligibility criteria, patient demographics and, perhaps most intriguingly, population-related pharmacogenomics. However, without methodology to control for such variables, these hypotheses remain largely untested. The authors previously developed the 'common arm' approach in order to directly compare efficacy and toxicity results of trials simultaneously performed in different countries. By standardizing clinical trial-associated variables such as treatment regimens (dose, schedule, and so on), eligibility, staging, response and toxicity criteria, this approach has the potential to determine the underlying reasons for divergences in trial outcomes across countries, and whether population-associated polymorphisms contribute to these differences. In the past decade, Japanese and US investigators have applied the common arm analytic method to trials in both extensive-stage small-cell lung cancer (SCLC) and advanced nonSCLC. In the SCLC analysis, a comparison of the cisplatin/irinotecan arms from both trials revealed significant differences in response rates and overall survival. Significant differences were also observed in the distribution of gender and performance status. The common arm analysis in nonSCLC included two trials from Japan and one from the USA, each containing a 'common' carboplatin/paclitaxel arm. Clinical results were similar in the two Japanese trials, but were significantly different from the US trial with regard to survival, neutropenia, febrile

  7. A randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of neramexane in patients with moderate to severe subjective tinnitus

    Directory of Open Access Journals (Sweden)

    Jastreboff Pawel J

    2011-01-01

    Full Text Available Abstract Background Neramexane is a new substance that exhibits antagonistic properties at α9α10 cholinergic nicotinic receptors and N-methyl-D-aspartate receptors, suggesting potential efficacy in the treatment of tinnitus. Methods A total of 431 outpatients with moderate to severe subjective tinnitus (onset 3-18 months before screening were assigned randomly to receive either placebo or neramexane mesylate (25 mg/day, 50 mg/day and 75 mg/day for 16 weeks, with assessment at 4-week intervals. The primary (intention-to-treat efficacy analysis was based on the change from baseline in Week 16 in the total score of the adapted German short version of the validated Tinnitus Handicap Inventory questionnaire (THI-12. Results Compared with placebo, the largest improvement was achieved in the 50 mg/d neramexane group, followed by the 75 mg/d neramexane group. This treatment difference did not reach statistical significance at the pre-defined endpoint in Week 16 (p = 0.098 for 50 mg/d; p = 0.289 for 75 mg/d neramexane, but consistent numerical superiority of both neramexane groups compared with placebo was observed. Four weeks after the end of treatment, THI-12 scores in the 50 mg/d group were significantly better than those of the controls. Secondary efficacy variables supported this trend, with p values of Conclusions This study demonstrated the safety and tolerability of neramexane treatment in patients with moderate to severe tinnitus. The primary efficacy variable showed a trend towards improvement of tinnitus suffering in the medium- and high-dose neramexane groups. This finding is in line with consistent beneficial effects observed in secondary assessment variables. These results allow appropriate dose selection for further studies. Trial Registration ClinicalTrials.gov NCT00405886

  8. Accuracy of Clinical Diagnosis of Dengue Episodes in the RV144 HIV Vaccine Efficacy Trial in Thailand.

    Directory of Open Access Journals (Sweden)

    Punnee Pitisuttithum

    Full Text Available RV144 was a community-based HIV vaccine efficacy trial conducted in HIV-uninfected adults in Thailand, where dengue virus continues to cause a large number of infections every year. We attempted to document the accuracy of clinically diagnosed dengue episodes reported as serious adverse events (SAEs and adverse events (AEs and examine whether dengue serology would support the clinical diagnosis. Subjects without a clinical dengue diagnosis but with an infection or idiopathic fever were selected as a control population. Dengue serology was performed by hemagglutination inhibition on plasma samples. A total of 124 clinical dengue episodes were reported (103 SAEs and 21 AEs. Overall 82.6% of the clinically diagnosed dengue episodes were supported by a positive dengue serology: 71.4% of the AEs and 85.0% of the SAEs. Of the 100 subjects with both clinical dengue and positive serology, all presented with fever, 83% with leucopenia, 54% with thrombocytopenia, and 27% with hemorrhagic symptoms. All episodes resolved spontaneously without sequellae. Only two of 15 subjects with a negative serology presented with fever. The sensitivity and specificity of clinical dengue diagnosis were 90.9% and 74.4%, respectively, when compared to the control population, and with a positive predictive value of 82.6% and negative predictive value of 84.7% when compared to dengue serology. Clinical diagnosis of dengue is an accurate method of dengue diagnosis in adults in Thailand. Large-scale clinical trials offer the opportunity to systematically study infectious diseases such as dengue and other infections that may occur during the trial.

  9. High efficacy of intravesical treatment of metformin on bladder cancer in preclinical model.

    Science.gov (United States)

    Peng, Mei; Su, Qiongli; Zeng, Qing; Li, Le; Liu, Zhihong; Xue, Lei; Cheng, Yan; Huang, Yanjun; Tao, Ting; Lv, Hongwei; Li, Xiaohui; Tao, Xiaojun; Guo, Peng; Chen, Alex F; Yang, Xiaoping

    2016-02-23

    Anticancer potential of metformin has been extensively studied. However, its anticancer clinical use remains yet to be approved since sufficient concentration on target organs could not be achieved via conventional administration. To overcome this drawback, we aim to examine the efficiency of novel intravesical treatment of metformin on syngeneic orthotopic preclinical model. Three human and one murine bladder cancer cell lines were tested in vitro for inhibitory sensitivity by MTT and cologenic assays. AMPK pathway including AKT, Erk and S6K was examined by western blot and further explored by regulating activated levels using specific inhibitors. In vivo efficacy was determined by Kaplan-Meier survival curves and measurements of body and bladder weights plus tumor biomarkers. Lactic acid and metformin levels of plasma were measured by standard procedures. The results demonstrated that metformin activated AMPK and decreased phosphorylation of Akt and Erk. Furthermore, combinations of metformin with either Akt or Erk inhibitors synergistically diminished cancer proliferation, suggesting the involvement of Akt- and Erk- related pathways. Intravesical metformin 26 and 104 mg/kg, twice per week demonstrated a rapid elimination of the implanted tumor without any evidence of toxicity. In contrast, oral treatment at a dose of 800mg/kg/d exhibited little efficacy whereas severe toxicity existed if the dosage is higher. Collectively, intravesical metformin displays potent inhibition on bladder cancer in vitro and this preclinical study reveals the profound therapeutic application of metformin with durable tolerance via intravesical administration route.

  10. Double-blind randomized placebo-controlled multicenter clinical trial (phase IIa) on diindolylmethane's efficacy and safety in the treatment of CIN: implications for cervical cancer prevention.

    Science.gov (United States)

    Ashrafian, Levon; Sukhikh, Gennady; Kiselev, Vsevolod; Paltsev, Mikhail; Drukh, Vadim; Kuznetsov, Igor; Muyzhnek, Ekaterina; Apolikhina, Inna; Andrianova, Evgeniya

    2015-01-01

    The article presents the results of a clinical trial on the efficacy and safety of a novel pharmaceutical composition in the form of vaginal suppositories containing diindolylmethane in the course of cervical intraepithelial neoplasia (CIN) I-II conservative treatment. It offers an attractive drug therapy for more personalized prevention of cervical cancer. A total of 78 women of reproductive age were included. This was a multicenter, randomized, placebo-controlled, double-blind, parallel-group trial with efficacy determined by histological evaluation of cervical biopsies. The efficacy of active drug treatment (100 and 200 mg/day) in both treatment groups was significantly higher in comparison with the placebo group, according to the primary efficacy end point (proportion of patients with complete CIN regression after 90-180 days of the study drug treatment). The efficacies were 100.0 % (confidence interval (CI) 95 %: 82.35-100.00 %), 90.5 % (CI 95 %: 69.62-98.83 %), and 61.1 % (CI 95 %: 35.75-82.70 %), for the high dose, low does, and placebo, respectively. Adverse events in the placebo group were reported in 22 % of patients (CI 95 %: 7.5-43.7 %); in the first treatment group (100 mg/day), adverse events were reported in 40.0 % of patients (CI 95 %: 21.1-61.3 %); in the second treatment group (200 mg/day), adverse events were reported in 42.0 % of patients (CI 95 %: 22.1-63.4 %). The differences in side effects between treatment groups treated with the active drug and placebo were statistically significant. No serious adverse events were reported in any of the groups. Thus, the use of diindolylmethane in the form of intravaginal suppositories can be effective in patients with CIN I-II and is not accompanied by clinically significant side effects. This approach could be a better option for young women with CIN I-II as it takes in attention their reproductive plans. ID: ChiCTR-INR-15007497 (2 December 2015).

  11. Role of quetiapine beyond its clinical efficacy in bipolar disorder: From neuroprotection to the treatment of psychiatric disorders (Review).