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Sample records for randomized comparison study

  1. Randomly and Non-Randomly Missing Renal Function Data in the Strong Heart Study: A Comparison of Imputation Methods.

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    Nawar Shara

    Full Text Available Kidney and cardiovascular disease are widespread among populations with high prevalence of diabetes, such as American Indians participating in the Strong Heart Study (SHS. Studying these conditions simultaneously in longitudinal studies is challenging, because the morbidity and mortality associated with these diseases result in missing data, and these data are likely not missing at random. When such data are merely excluded, study findings may be compromised. In this article, a subset of 2264 participants with complete renal function data from Strong Heart Exams 1 (1989-1991, 2 (1993-1995, and 3 (1998-1999 was used to examine the performance of five methods used to impute missing data: listwise deletion, mean of serial measures, adjacent value, multiple imputation, and pattern-mixture. Three missing at random models and one non-missing at random model were used to compare the performance of the imputation techniques on randomly and non-randomly missing data. The pattern-mixture method was found to perform best for imputing renal function data that were not missing at random. Determining whether data are missing at random or not can help in choosing the imputation method that will provide the most accurate results.

  2. A comparison of two stretching programs for hamstring muscles: A randomized controlled assessor-blinded study.

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    Demoulin, Christophe; Wolfs, Sébastien; Chevalier, Madeline; Granado, Caroline; Grosdent, Stéphanie; Depas, Yannick; Roussel, Nathalie; Hage, Renaud; Vanderthommen, Marc

    2016-01-01

    Most parameters regarding hamstring flexibility training programs have been investigated; however, the joint (i.e. hip or knee) on which the stretching should preferentially be focused needs to be further explored. This randomized controlled assessor-blinded study aimed to investigate the influence of this parameter. We randomly assigned 111 asymptomatic participants with tight hamstring muscles in three groups: a control group and two groups following a different home-based 8-week (five 10-minute sessions per week) hamstring stretching program (i.e. stretching performed by flexing the hip while keeping the knee extended [SH] or by first flexing the hip with a flexed knee and then extending the knee [SK]). Range of motion (ROM) of hip flexion and knee extension were measured before and after the stretching program by means of the straight leg raising test and the passive knee extension angle test, respectively. Eighty-nine participants completed the study. A significant increase in ROM was observed at post-test. Analyses showed significant group-by-time interactions for changes regarding all outcomes. Whereas the increase in hip flexion and knee extension ROM was higher in the stretching groups than in the CG (especially for the SH group p 0.05). In conclusion, the fact that both stretching programs resulted in similar results suggests no influence of the joint at which the stretching is focused upon, as assessed by the straight leg raising and knee extension angle tests.

  3. Comparison of Levetiracetam and sodium Valproate in migraine prophylaxis: A randomized placebo-controlled study

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    Homa Sadeghian

    2015-01-01

    Full Text Available Background: Migraine is a chronic and disabling disorder. Treatment of migraine often comprises of symptomatic (abortive and preventive (prophylactic treatment. The current drugs used in migraine prophylaxis include antidepressant drugs (Serotonin Reuptake Inhibitors, Tricyclic antidepressants, and anti-epileptic drugs (valproate, gabapentin, etc. Objective: The objective of our study was to assess the efficacy and tolerability of levetiracetam in adult migraine prophylaxis, compared to valproate and placebo. Materials and Methods: We conducted a prospective, randomized, placebo-controlled study. A total of 85 patients were randomized to receive levetiracetam 500 mg/d (n = 27, valproate 500 mg/d (n = 32 or placebo (n = 26. The patients were evaluated for treatment efficacy after 6 months. Efficacy was assessed as a more than 50% decrease in headache frequency. Results: In levetiracetam group, 17 (63.0% patients experienced a more than 50% decrease in headache frequency, while this efficacy number was 21 (65.6% for valproate group and 4 (15.4% for placebo group. The difference was not statistically significant between levetiracetam and valproate, while it was significant when comparing either levetiracetam or valproate to placebo. Conclusion: Compared to placebo, levetiracetam offers improvement in headache frequency in patients with migraine. The efficacy of levetiracetam in migraine prophylaxis is comparable to currently used drugs such as valproate.

  4. Comparison of antiemetic efficacy of granisetron and ondansetron in Oriental patients: a randomized crossover study.

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    Poon, R. T.; Chow, L. W.

    1998-01-01

    A double-blind randomized crossover trial was performed to compare the antiemetic efficacy of two 5-HT3 receptor antagonists, granisetron and ondansetron, in Chinese patients receiving adjuvant chemotherapy (cyclophosphamide, methotrexate and 5-fluorouracil) for breast cancer. Twenty patients were randomized to receive chemotherapy with either granisetron on day 1 and ondansetron on day 8 of the first cycle followed by the reverse order in the second cycle, or vice versa. The number of vomiting episodes and the severity of nausea in the first 24 h (acute vomiting/nausea) and the following 7 days (delayed vomiting/nausea) were studied. Acute vomiting was completely prevented in 29 (72.5%) cycles with granisetron and 27 (67.5%) cycles with ondansetron, and treatment failure (>5 vomiting episodes) occurred in two (5%) cycles with each agent (P = NS). Acute nausea was completely controlled in 15 (37.5%) cycles with granisetron and 14 (35%) cycles with ondansetron, whereas severe acute nausea occurred in four (10%) cycles with each agent (P = NS). However, complete response for delayed vomiting was observed in only 21 (52.5%) cycles with granisetron and 22 (55%) cycles with ondansetron (P = NS), and delayed nausea was completely controlled in only 11 (27.5%) and ten (25%) cycles respectively (P = NS). In conclusion, both granisetron and ondansetron are effective in controlling acute nausea and vomiting in Chinese patients, with equivalent antiemetic efficacy. Control of delayed nausea and vomiting is less satisfactory. PMID:9635849

  5. Meta-analytic comparison of randomized and nonrandomized studies of breast cancer surgery.

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    Edwards, Janet P; Kelly, Elizabeth J; Lin, Yongtao; Lenders, Taryn; Ghali, William A; Graham, Andrew J

    2012-06-01

    Randomized controlled trials (RCTs) are thought to provide the most accurate estimation of "true" treatment effect. The relative quality of effect estimates derived from nonrandomized studies (nRCTs) remains unclear, particularly in surgery, where the obstacles to performing high-quality RCTs are compounded. We performed a meta-analysis of effect estimates of RCTs comparing surgical procedures for breast cancer relative to those of corresponding nRCTs. English-language RCTs of breast cancer treatment in human patients published from 2003 to 2008 were identified in MEDLINE, EMBASE and Cochrane databases. We identified nRCTs using the National Library of Medicine's "related articles" function and reference lists. Two reviewers conducted all steps of study selection. We included studies comparing 2 surgical arms for the treatment of breast cancer. Information on treatment efficacy estimates, expressed as relative risk (RR) for outcomes of interest in both the RCTs and nRCTs was extracted. We identified 12 RCTs representing 10 topic/outcome combinations with comparable nRCTs. On visual inspection, 4 of 10 outcomes showed substantial differences in summary RR. The pooled RR estimates for RCTs versus nRCTs differed more than 2-fold in 2 of 10 outcomes and failed to demonstrate consistency of statistical differences in 3 of 10 cases. A statistically significant difference, as assessed by the z score, was not detected for any of the outcomes. Randomized controlled trials comparing surgical procedures for breast cancer may demonstrate clinically relevant differences in effect estimates in 20%-40% of cases relative to those generated by nRCTs, depending on which metric is used.

  6. A Comparison of Online versus On-site Training in Health Research Methodology: A Randomized Study

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    Kanchanaraksa Sukon

    2011-06-01

    Full Text Available Abstract Background Distance learning may be useful for building health research capacity. However, evidence that it can improve knowledge and skills in health research, particularly in resource-poor settings, is limited. We compared the impact and acceptability of teaching two distinct content areas, Biostatistics and Research Ethics, through either on-line distance learning format or traditional on-site training, in a randomized study in India. Our objective was to determine whether on-line courses in Biostatistics and Research Ethics could achieve similar improvements in knowledge, as traditional on-site, classroom-based courses. Methods Subjects: Volunteer Indian scientists were randomly assigned to one of two arms. Intervention: Students in Arm 1 attended a 3.5-day on-site course in Biostatistics and completed a 3.5-week on-line course in Research Ethics. Students in Arm 2 attended a 3.5-week on-line course in Biostatistics and 3.5-day on-site course in Research Ethics. For the two course formats, learning objectives, course contents and knowledge tests were identical. Main Outcome Measures: Improvement in knowledge immediately and 3-months after course completion, compared to baseline. Results Baseline characteristics were similar in both arms (n = 29 each. Median knowledge score for Biostatistics increased from a baseline of 49% to 64% (p Conclusion On-line and on-site training formats led to marked and similar improvements of knowledge in Biostatistics and Research Ethics. This, combined with logistical and cost advantages of on-line training, may make on-line courses particularly useful for expanding health research capacity in resource-limited settings.

  7. Comparison of intravenous versus topical tranexamic acid in total knee arthroplasty: a prospective randomized study.

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    Patel, Jay N; Spanyer, Jonathon M; Smith, Langan S; Huang, Jiapeng; Yakkanti, Madhusudhan R; Malkani, Arthur L

    2014-08-01

    The purpose of this study was to compare the efficacy of topical Tranexamic Acid (TXA) versus Intravenous (IV) Tranexamic Acid for reduction of blood loss following primary total knee arthroplasty (TKA). This prospective randomized study involved 89 patients comparing topical administration of 2.0g TXA, versus IV administration of 10mg/kg. There were no differences between the two groups with regard to patient demographics or perioperative function. The primary outcome measure, perioperative change in hemoglobin level, showed a decrease of 3.06 ± 1.02 in the IV group and 3.42 ± 1.07 in the topical group (P = 0.108). There were no statistical differences between the groups in preoperative hemoglobin level, lowest postoperative hemoglobin level, or total drain output. One patient in the topical group required blood transfusion (P = 0.342). Based on our study, topical Tranexamic Acid has similar efficacy to IV Tranexamic Acid for TKA patients. Copyright © 2014 Elsevier Inc. All rights reserved.

  8. Comparison of natural drainage group and negative drainage groups after total thyroidectomy: prospective randomized controlled study.

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    Woo, Seung Hoon; Kim, Jin Pyeong; Park, Jung Je; Shim, Hyun Seok; Lee, Sang Ha; Lee, Ho Joong; Won, Seong Jun; Son, Hee Young; Kim, Rock Bum; Son, Young-Ik

    2013-01-01

    The aim of this study was to compare a negative pressure drain with a natural drain in order to determine whether a negative pressure drainage tube causes an increase in the drainage volume. Sixty-two patients who underwent total thyroidectomy for papillary thyroid carcinoma (PTC) were enrolled in the study between March 2010 and August 2010 at Gyeongsang National University Hospital. The patients were prospectively and randomly assigned to two groups, a negative pressure drainage group (n=32) and natural drainage group (n=30). Every 3 hours, the volume of drainage was checked in the two groups until the tube was removed. The amount of drainage during the first 24 hours postoperatively was 41.68 ± 3.93 mL in the negative drain group and 25.3 ± 2.68 mL in the natural drain group (pdrain group was 35.19 ± 4.26 mL and natural drain groups 21.53 ± 2.90 mL (pdrain may increase the amount of drainage during the first 24-48 hours postoperatively. Therefore, it is not necessary to place a closed suction drain when only a total thyroidectomy is done.

  9. Comparison of education and balneotherapy efficacy in patients with fibromyalgia syndrome: A randomized, controlled clinical study.

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    Koçyiğit, Burhan Fatih; Gür, Ali; Altındağ, Özlem; Akyol, Ahmet; Gürsoy, Savaş

    2016-04-01

    Fibromyalgia is a disease characterized by chronic, widespread pain. Pharmacological and non-pharmacological treatment methods are used. The aim of the present study was to determine the effect of balneotherapy on treatment of fibromyalgia syndrome, compared with education alone. A total of 66 patients diagnosed with fibromyalgia syndrome were randomly separated into balneotherapy and control groups. Patients in both groups were informed about fibromyalgia syndrome. In addition, the balneotherapy group received 21 sessions of spa treatment with 34.8 °C thermomineral water, attending the spa 5 days a week. Patients were evaluated by visual analogue scale, tender point count, fibromyalgia impact questioning, and modified fatigue impact scale at initiation of treatment on the 15th day, 1st month, 3rd month, and 6th month. Evaluations were performed by the same doctor. Statistically significant improvement was detected in all parameters, compared to starting evaluation, in both groups. Most improved results among all parameters were observed in the balneotherapy group on the first 3-month follow-up. In addition, all parameters beyond tender point count and modified fatigue impact were improved on 6-month follow-up. It was concluded that addition of balneotherapy to patient education has both short- and long-term beneficial effects on female patients with fibromyalgia.

  10. Comparison of minimalist footwear strategies for simulating barefoot running: a randomized crossover study.

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    Karsten Hollander

    Full Text Available Possible benefits of barefoot running have been widely discussed in recent years. Uncertainty exists about which footwear strategy adequately simulates barefoot running kinematics. The objective of this study was to investigate the effects of athletic footwear with different minimalist strategies on running kinematics. Thirty-five distance runners (22 males, 13 females, 27.9 ± 6.2 years, 179.2 ± 8.4 cm, 73.4 ± 12.1 kg, 24.9 ± 10.9 km x week(-1 performed a treadmill protocol at three running velocities (2.22, 2.78 and 3.33 m x s(-1 using four footwear conditions: barefoot, uncushioned minimalist shoes, cushioned minimalist shoes, and standard running shoes. 3D kinematic analysis was performed to determine ankle and knee angles at initial foot-ground contact, rate of rear-foot strikes, stride frequency and step length. Ankle angle at foot strike, step length and stride frequency were significantly influenced by footwear conditions (p<0.001 at all running velocities. Posthoc pairwise comparisons showed significant differences (p<0.001 between running barefoot and all shod situations as well as between the uncushioned minimalistic shoe and both cushioned shoe conditions. The rate of rear-foot strikes was lowest during barefoot running (58.6% at 3.33 m x s(-1, followed by running with uncushioned minimalist shoes (62.9%, cushioned minimalist (88.6% and standard shoes (94.3%. Aside from showing the influence of shod conditions on running kinematics, this study helps to elucidate differences between footwear marked as minimalist shoes and their ability to mimic barefoot running adequately. These findings have implications on the use of footwear applied in future research debating the topic of barefoot or minimalist shoe running.

  11. Comparison of minimalist footwear strategies for simulating barefoot running: a randomized crossover study.

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    Hollander, Karsten; Argubi-Wollesen, Andreas; Reer, Rüdiger; Zech, Astrid

    2015-01-01

    Possible benefits of barefoot running have been widely discussed in recent years. Uncertainty exists about which footwear strategy adequately simulates barefoot running kinematics. The objective of this study was to investigate the effects of athletic footwear with different minimalist strategies on running kinematics. Thirty-five distance runners (22 males, 13 females, 27.9 ± 6.2 years, 179.2 ± 8.4 cm, 73.4 ± 12.1 kg, 24.9 ± 10.9 km x week(-1)) performed a treadmill protocol at three running velocities (2.22, 2.78 and 3.33 m x s(-1)) using four footwear conditions: barefoot, uncushioned minimalist shoes, cushioned minimalist shoes, and standard running shoes. 3D kinematic analysis was performed to determine ankle and knee angles at initial foot-ground contact, rate of rear-foot strikes, stride frequency and step length. Ankle angle at foot strike, step length and stride frequency were significantly influenced by footwear conditions (prunning velocities. Posthoc pairwise comparisons showed significant differences (prunning barefoot and all shod situations as well as between the uncushioned minimalistic shoe and both cushioned shoe conditions. The rate of rear-foot strikes was lowest during barefoot running (58.6% at 3.33 m x s(-1)), followed by running with uncushioned minimalist shoes (62.9%), cushioned minimalist (88.6%) and standard shoes (94.3%). Aside from showing the influence of shod conditions on running kinematics, this study helps to elucidate differences between footwear marked as minimalist shoes and their ability to mimic barefoot running adequately. These findings have implications on the use of footwear applied in future research debating the topic of barefoot or minimalist shoe running.

  12. Topiramate versus fluvoxamine in the treatment of pathological gambling: a randomized, blind-rater comparison study.

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    Dannon, Pinhas N; Lowengrub, Katherine; Gonopolski, Yehudit; Musin, Ernest; Kotler, Moshe

    2005-01-01

    Pathologic gambling (PG) is a highly prevalent and disabling impulse control disorder. Recent studies have demonstrated that PG patients respond well to treatment with SSRIs, mood stabilizers, and opioid antagonists. These findings support the idea that PG and other disorders of impulse control may be conceptualized as part of the obsessive-compulsive spectrum disorders. Pilot studies have shown topiramate to be effective in the treatment of specific disorders of impulse control. The aim of the study is to compare the effectiveness of topiramate versus fluvoxamine in the treatment of PG. Thirty-one male PGs were assigned in a randomized fashion to receive either topiramate (15/31) or fluvoxamine (16/31) pharmacotherapy for 12 weeks. A comprehensive psychiatric diagnostic evaluation was performed on all patients, and all patients were evaluated for symptoms of gambling, depression, and anxiety using the South Oaks Gambling Screen, the Hamilton Depression Rating Scale, the Hamilton Anxiety Rating Scale, the Yale-Brown Obsessive Compulsive Symptoms Scale, and the Clinical Global Impression-Improvement Scale. The rating scales were administered at baseline and at the 12-week endpoint. In addition, the patients completed self-report questionnaires about their demographic status. Twelve of the 15 patients from the topiramate group completed the 12-week treatment. Nine of the 12 topiramate completers reported full remission of gambling behavior, and 3 completers had a partial remission. The CGI-improvement score was significantly better for the topiramate group at the 12-week visit as compared with baseline (F = 10.5, P < 0.01, df = 2.31). In the fluvoxamine treatment group 8/16 patients completed the study, and 6/8 fluvoxamine completers reported a full remission, and the remaining 2/8 fluvoxamine completers reported a partial remission. The fluvoxamine group showed improvement in the CGI-improvement score at week 12, although this difference was not significant (F = 3

  13. Comparison of early surgical alternatives in the management of open abdomen: a randomized controlled study.

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    Rencüzoğulları, Ahmet; Dalcı, Kubilay; Eray, İsmail Cem; Yalav, Orçun; Okoh, Alexis Kofi; Akcam, Tolga; Ülkü, Abdullah; Sakman, Gürhan; Parsak, Cem P

    2015-05-01

    Abdominal compartment syndrome (ACS) is a clinical syndrome characterized by progressive intraabdominal organ dysfunction resulting from an acute increase in intra-abdominal pressure (IAP). In the absence of prompt treatment, ACS can lead to lethal organ failure. Treatment of ACS is achieved by immediate decompression of the abdominal cavity. As to how and when decompression laparotomy should be performed depends on the clinical condition of the patients. There is limited data regarding outcomes of abdominal closure techiques. The present study aimed to investigate two different temporary closure methods, the vacuum assisted closure (VAC) and Bogota bag techniques, in 40 patients who underwent decompressive laparotomy as part of the management of ACS. The study included 40 patients who developed ACS during follow-up or following trauma and abdominal surgery. As part of the treatment for ACS, these patients underwent decompressive laparotomy at the Cukurova University Medical Faculty, General Surgery Department and followed up in the Intensive Care Unit of the same hospital. VAC and Bogota bag procedures were performed as temporary closure methods for the treatment of ACS. Patients were randomly assigned to each of the two groups according to the temporary closure method performed. Clinical, laboratory, mortality and morbidity results of the patients in both groups were compared. Demographic features of the patients (age, sex, body mass index, co-morbidities) were similar between the two groups. The most common reason of ACS was gastrointestinal perforation in 12 (30%) patients. Decrease in incision width was significantly faster in the VAC group than in the Bogota group. Primary closure of fascia was considered appropriate in 16.9 days in the VAC group and 20.5 days in the Bogota bag group. The decrease in abdominal pressure was similar between the two groups on days 1, 4 and 7 but appeared to be significantly lower on day 14 in the VAC group. 12 patients (30

  14. Comparison of granisetron and lidocaine on reducing injection pain of etomidate: a controlled randomized study

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    Alireza Saliminia

    Full Text Available Abstract Background and objectives Reducing pain on injection of anesthetic drugs is of importance to every anesthesiologist. In this study we pursued to define if pretreatment by granisetron reduces the pain on injection of etomidate similar to lidocaine. Methods Thirty patients aged between 18 and 50 years of American Society of Anesthesiologists physical status class I or II, whom were candidates for elective laparoscopic cholecystectomy surgery were enrolled in this study. Two 20 gauge cannulas were inserted into the veins on the dorsum of both hands and 100 mL of normal saline was administered during a 10 min period from each cannula. Using an elastic band as a tourniquet, venous drainage of both hands was occluded. 2 mL of granisetron was administered into one hand and 2 mL of lidocaine 2% at the same time into the other hand. One minute later the elastic band was opened and 2 mL of etomidate was administered to each hand with equal rates. The patients were asked to give a score from 0 to 10 (0 = no pain, 10 = severe pain to each the pain sensed in each hand. Results Two patients were deeply sedated after injection of etomidate and unable to answer any questions. The mean numerical rating score for injection pain of intravenously administered etomidate after intravenous granisetron was 2.3 ± 1.7, which was lower when compared with pain sensed due to intravenously administered etomidate after administration of lidocaine 2% (4.6 ± 1.8, p < 0.05. Conclusion The result of this study demonstrated that, granisetron reduces pain on injection of etomidate more efficiently than lidocaine.

  15. Comparison of granisetron and lidocaine on reducing injection pain of etomidate: a controlled randomized study

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    Alireza Saliminia

    2017-11-01

    Full Text Available Background and objectives: Reducing pain on injection of anesthetic drugs is of importance to every anesthesiologist. In this study we pursued to define if pretreatment by granisetron reduces the pain on injection of etomidate similar to lidocaine. Methods: Thirty patients aged between 18 and 50 years of American Society of Anesthesiologists physical status class I or II, whom were candidates for elective laparoscopic cholecystectomy surgery were enrolled in this study. Two 20 gauge cannulas were inserted into the veins on the dorsum of both hands and 100 mL of normal saline was administered during a 10 min period from each cannula. Using an elastic band as a tourniquet, venous drainage of both hands was occluded. 2 mL of granisetron was administered into one hand and 2 mL of lidocaine 2% at the same time into the other hand. One minute later the elastic band was opened and 2 mL of etomidate was administered to each hand with equal rates. The patients were asked to give a score from 0 to 10 (0 = no pain, 10 = severe pain to each the pain sensed in each hand. Results: Two patients were deeply sedated after injection of etomidate and unable to answer any questions. The mean numerical rating score for injection pain of intravenously administered etomidate after intravenous granisetron was 2.3 ± 1.7, which was lower when compared with pain sensed due to intravenously administered etomidate after administration of lidocaine 2% (4.6 ± 1.8, p < 0.05. Conclusion: The result of this study demonstrated that, granisetron reduces pain on injection of etomidate more efficiently than lidocaine. Resumo: Justificativa e objetivos: A redução da dor causada pela injeção de anestésicos é importante para todos os anestesiologistas. Neste estudo buscamos definir se o pré-tratamento com granisetrona reduz a dor causada pela injeção de etomidato de forma semelhante à lidocaína. Métodos: Trinta pacientes com idades entre 18 e 50 anos

  16. Comparison between three option, four option and five option multiple choice question tests for quality parameters: A randomized study.

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    Vegada, Bhavisha; Shukla, Apexa; Khilnani, Ajeetkumar; Charan, Jaykaran; Desai, Chetna

    2016-01-01

    Most of the academic teachers use four or five options per item of multiple choice question (MCQ) test as formative and summative assessment. Optimal number of options in MCQ item is a matter of considerable debate among academic teachers of various educational fields. There is a scarcity of the published literature regarding the optimum number of option in each item of MCQ in the field of medical education. To compare three options, four options, and five options MCQs test for the quality parameters - reliability, validity, item analysis, distracter analysis, and time analysis. Participants were 3 rd semester M.B.B.S. students. Students were divided randomly into three groups. Each group was given one set of MCQ test out of three options, four options, and five option randomly. Following the marking of the multiple choice tests, the participants' option selections were analyzed and comparisons were conducted of the mean marks, mean time, validity, reliability and facility value, discrimination index, point biserial value, distracter analysis of three different option formats. Students score more ( P = 0.000) and took less time ( P = 0.009) for the completion of three options as compared to four options and five options groups. Facility value was more ( P = 0.004) in three options group as compared to four and five options groups. There was no significant difference between three groups for the validity, reliability, and item discrimination. Nonfunctioning distracters were more in the four and five options group as compared to three option group. Assessment based on three option MCQs is can be preferred over four option and five option MCQs.

  17. Comparison of microdose flare-up and antagonist multiple-dose protocols for poor-responder patients: a randomized study.

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    Demirol, Aygul; Gurgan, Timur

    2009-08-01

    To compare the efficacy of the microdose flare-up and multiple-dose antagonist protocols for poor-responder patients in intracytoplasmic sperm injection-ET cycles. A randomized, prospective study. Center for assisted reproductive technology in Turkey. Ninety patients with poor ovarian response in a minimum of two previous IVF cycles. All women were prospectively randomized into two groups by computer-assisted randomization. The patients in group 1 were stimulated according to the microdose flare-up protocol (n = 45), while the patients in group 2 were stimulated according to antagonist multiple-dose protocol (n = 45). The mean number of mature oocytes retrieved was the primary outcome measure, and fertilization rate, implantation rate per embryo, and clinical pregnancy rates were secondary outcome measures. The mean age of the women, the mean duration of infertility, basal FSH level, and the number of previous IVF cycles were similar in both groups. The total gonadotropin dose used was significantly higher in group 2, while the number of oocytes retrieved was significantly greater in group 1. Although the fertilization and clinical pregnancy rates were nonsignificantly higher in group 1 compared with group 2, the implantation rate was significantly higher in the microdose flare-up group than in the multiple-dose antagonist group (22% vs. 11%). The microdose flare-up protocol seems to have a better outcome in poor-responder patients, with a significantly higher mean number of mature oocytes retrieved and higher implantation rate.

  18. Comparison of olanzapine and risperidone in the EMBLEM Study: translation of randomized controlled trial findings into clinical practice.

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    Novick, Diego; Reed, Catherine; Haro, Josep Maria; Gonzalez-Pinto, Ana; Perrin, Elena; Aguado, Jaume; Tohen, Mauricio

    2010-09-01

    Data from the EMBLEM Study, a 2-year, prospective, observational study of health outcomes associated with acute treatment of patients experiencing a manic/mixed episode of bipolar disorder, was used to compare the effectiveness of olanzapine monotherapy versus risperidone monotherapy, and to investigate whether the treatment effects were similar to those reported in a 3-week, randomized controlled trial assessing the same treatments. Symptom severity measures included the Young Mania Rating Scale (YMRS), the 5-item Hamilton Depression Rating Scale, and the Clinical Global Impression-Bipolar Disorder Scale. A total of 245 EMBLEM inpatients were analyzed with YMRS >or=20: olanzapine (n=209), risperidone (n=36). Both the treatment groups had similar improvements in YMRS from baseline to 6 weeks, but there was a significantly greater improvement in 5-item Hamilton Depression Rating Scale in the olanzapine group. There was a similar improvement in Clinical Global Impression-Bipolar Disorder Scale in both the groups and the occurrence of treatment-emergent adverse events and weight gain did not differ between the treatment groups. The EMBLEM results partly support those of the randomized controlled trial, which suggests olanzapine and risperidone have similar improvements in mania but that olanzapine monotherapy may be more effective than risperidone monotherapy in the treatment of depressive symptoms associated with mania. Limitations include differences in study design, patient population, and length of follow-up.

  19. Renal denervation in comparison with intensified pharmacotherapy in true resistant hypertension: 2-year outcomes of randomized PRAGUE-15 study.

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    Rosa, Ján; Widimský, Petr; Waldauf, Petr; Zelinka, Tomáš; Petrák, Ondřej; Táborský, Miloš; Branny, Marian; Toušek, Petr; Čurila, Karol; Lambert, Lukáš; Bednář, František; Holaj, Robert; Štrauch, Branislav; Václavík, Jan; Kociánová, Eva; Nykl, Igor; Jiravský, Otakar; Rappová, Gabriela; Indra, Tomáš; Krátká, Zuzana; Widimský, Jiří

    2017-05-01

    The randomized, multicentre study compared the efficacy of renal denervation (RDN) versus spironolactone addition in patients with true resistant hypertension. We present the 24-month data. A total of 106 patients with true resistant hypertension were enrolled in this study: 52 patients were randomized to RDN and 54 patients to the spironolactone addition, with baseline SBP of 159 ± 17 and 155 ± 17 mmHg and average number of drugs 5.1 and 5.4, respectively. Two-year data are available in 86 patients. Spironolactone addition, as crossover after 1 year, was performed in 23 patients after RDN, and spironolactone addition followed by RDN was performed in five patients. Similar and comparable reduction of 24-h SBP after RDN or spironolactone addition after randomization was observed, 9.1 mmHg (P = 0.001) and 10.9 mmHg (P = 0.001), respectively. Similar decrease of office blood pressure (BP) was observed, 17.7 mmHg (P efficacy of spironolactone addition in 24-h SBP and office SBP reduction than RDN (3.7 mmHg, P = 0.27 and 4.6 mmHg, P = 0.28 in favour of spironolactone addition, respectively). Meanwhile, the number of antihypertensive drugs was significantly increased after spironolactone addition (+0.7, P = 0.001). In the settings of true resistant hypertension, spironolactone addition (if tolerated) seems to be of better efficacy than RDN in BP reduction over a period of 24 months. However, by contrast to the 12-month results, BP changes were not significantly greater.

  20. Comparison of Tension-Band Wiring With the Cable Pin System in Patella Fractures: A Randomized Prospective Study.

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    Tian, Qing-xian; Hai, Yong; Du, Xin-ru; Xu, Zi-yu; Lu, Tie; Shan, Lei; Liu, Yang; Zhou, Jun-lin

    2015-12-01

    To compare the outcome of tension-band wiring (TBW) with the cable pin system (CPS) for transverse fractures of the patella. Randomized prospective study. Academic Level I trauma center. From February 2008 to December 2011, 73 consecutive patients with transverse fractures of the patella were prospectively enrolled in this study. The patients were randomly divided into 2 groups: one group was treated using the CPS, and the other group was treated using the modified TBW. The clinical outcome assessment included analyses of the radiographic images, the modified Hospital for Special Surgery scoring system, and complications. The follow-up time ranged from 12 to 29 months. All fractures healed, with a union rate of 100%. The fracture healing time was significantly shorter in the CPS group (8.51 ± 2.59 weeks, n = 34) compared with the TBW group (11.79 ± 3.04 weeks, n = 39). Postoperative complications in the CPS and TBW groups were observed in 1 and 9 patients, respectively, a difference that was statistically significant. The mean Hospital for Special Surgery score for the CPS group (90.53 ± 5.19 points) was significantly higher than that for the TBW group (81.36 ± 12.71 points). The CPS is a viable option for transverse fractures of the patella and is associated with a shorter healing time, fewer complications, and better function than TBW. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

  1. PONV in Ambulatory surgery: A comparison between Ramosetron and Ondansetron: a prospective, double-blinded, and randomized controlled study

    Directory of Open Access Journals (Sweden)

    Debasis Banerjee

    2014-01-01

    Full Text Available Background: postoperative nausea and vomiting (PONV frequently hampers implementation of ambulatory surgery in spite of so many antiemetic drugs and regimens. Aims: the study was carried out to compare the efficacy of Ramosetron and Ondansetron in preventing PONV after ambulatory surgery. Setting and Design: it was a prospective, double blinded, and randomized controlled study. Methods: 124 adult patients of either sex, aged 25-55, of ASA physical status I and II, scheduled for day care surgery, were randomly allocated into Group A [(n=62 receiving (IV Ondansetron (4 mg] and Group B [(n=62 receiving IV Ramosetron (0.3 mg] prior to the induction of general anesthesia in a double-blind manner. Episodes of PONV were noted at 0.5, 1, 2, 4 h, 6 , 12, and 18 h postoperatively. Statistical Analysis and Results: statistically significant difference between Groups A and B (P <0.05 was found showing that Ramosetron was superior to Ondansetron as antiemetic both regarding frequency and severity. Conclusion: it was evident that preoperative prophylactic administration of single dose IV Ramosetron (0.3 mg has better efficacy than single dose IV Ondansetron (4 mg in reducing the episodes of PONV over 18 h postoperatively in patients undergoing day-care surgery under general anesthesia.

  2. Comparison of escalating, constant, and reduction energy output in ESWL for renal stones: multi-arm prospective randomized study.

    Science.gov (United States)

    Rabah, Danny M; Mabrouki, Mohamed S; Farhat, Karim H; Seida, Mohamed A; Arafa, Mostafa A; Talic, Riyadh F

    2017-06-01

    This study was designed to find out the optimized energy delivery strategy in Shock Wave Lithotripsy (SWL) that yield to the best stone-free rate (SFR). In this clinical trial, 150 consecutive patients were randomized into three groups: (a) Dose escalation, 1500 SW at 18 kV, followed by 1500 SW at 20 kV then 1500 SW at 22 kV. (b) Constant dose, 4500 SW at 20 kV. All patients undergo plain X-ray film of the urinary tract at day 1, 14, and 90 to assess stone-free rate (SFR) which was defined as no stones or painless fragments less than 4 mm. (c) Dose reduction, 1500 SW at 22 kV, followed by 1500 SW at 20 kV and then 1500 SW at 18 kV. The three treatment groups were comparable in terms of age, sex, stone size and distribution of the kidneys, and the need for Double J stent use. On day 90, the SFR achieved was 82, 90, and 84 % in the escalating, constant, and reduction energy groups, respectively. However, this rate was not statistically significant (x 2  = 1.38, p level = 0.28). At a slow rate of 60 shocks, there was no difference in stone-free rate between different voltages at 1, 14, and 90 days. Our randomized clinical trial showed no statistically significant difference in SFR between the three groups while using the slow SWL rate. Our trial is the first randomized trial comparing the three strategies. As such, a dose adjustment strategy while delivering SWL in slow rate was not recommended.

  3. Comparison of the effectiveness of resistance training in women with chronic computer-related neck pain: a randomized controlled study.

    Science.gov (United States)

    Li, Xiao; Lin, Caina; Liu, Cuicui; Ke, Songjian; Wan, Qing; Luo, Haijie; Huang, Zhuxi; Xin, Wenjun; Ma, Chao; Wu, Shaoling

    2017-10-01

    Chronic computer-related neck pain is common among office workers. Studies have proposed neck strengthening exercise as a therapy to pain relieving and function improvement. The aim of this study was to compare the efficacy of different loading resistance trainings and we hypothesized that women with work-related neck pain could benefit more from progressive resistance training for pain and function recovery. A randomized controlled trial was conducted and subjects characterized by monotonous jobs were recruited. One hundred and nine employed women with chronic neck pain were randomly allocated into three groups, namely, progressive resistance training (PRT), fixed resistance training (FRT), and control group (CG). In PRT and FRT, four exercises for neck muscles with an elastic rubber band were performed on regular basis for 6 weeks. The therapeutic effectiveness was then evaluated at pretreatment, 2, 4, and 6 weeks during training period, and 3-month posttreatment. Assessment tools included visual analog scale (VAS), Neck Disability Index (NDI), pressure pain threshold (PPT), and maximal isometric neck strength. The outcomes were significantly better in PRT and FRT than those in CG at 6-week timepoint and 3-month follow-up (p = 0.000), in terms of VAS, NDI, PPT, and neck muscle strength. Besides, there were statistically significant decreases observed in VAS scores of PRT group compared with those in FRT at 4-, 6-week timepoints, and 3-month follow-up (p training was an effective method for pain relieving, mobility improving, pain threshold, and neck muscle strength enhancing in women with chronic computer-related neck pain. Thus, our study provided evidence that women with work-related neck pain might benefit more from PRT, which may have important implications for future clinical practice. The study was qualified and registered in the Chinese Clinical Trial Registry as ChiCTR-TRC-12002723.

  4. Randomized, double blind comparison of brand and generic antibiotic suspensions: II. A study of taste and compliance in children.

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    El-Chaar, G M; Mardy, G; Wehlou, K; Rubin, L G

    1996-01-01

    The taste of oral liquid medications influences compliance in children. Generic preparations are prescribed to reduce cost and may taste worse than brand name products. This was a prospective, randomized, double blind, crossover trial of the differences in taste and compliance between brand and generic antibiotic suspensions in children 3 to 14 years of age. Verbal and visual assessment methods were used to assess taste, and compliance was measured by the amount of drug returned after use. Ten children in each of the cephalexin and erythromycin-sulfisoxazole groups did not report that the brand and generic formulations tasted differently. Fifteen children thought that brand trimethoprim-sulfamethoxazole tasted better than the generic preparation. Brand name oral liquid antibiotics do not necessarily taste better than their generic counterparts. Despite preference for the taste of brand trimethoprim-sulfamethoxazole, all of the children in this study were compliant with both brand and generic medications.

  5. Comparison of two school-based programmes for health behaviour change: the Belo Horizonte Heart Study randomized trial.

    Science.gov (United States)

    Ribeiro, Robespierre Q C; Alves, Luciana

    2014-06-01

    To assess the efficacy of two school-based programmes to promote students' willingness to engage in lifestyle changes related to eating habits and physical activity behaviours. Elementary school-based health promotion intervention, designed as a multicomponent experimental study, based on a behavioural epidemiological model. Nine intervention and eight comparative public and private elementary schools. The goal was to determine the impact on the longitudinally assessed outcomes of two programmes that addressed healthy nutrition and active living in a cohort of 2038 children. The evaluations used pre-intervention and follow-up student surveys that were based on the Transtheoretical Model of the stages of behaviour change. In the intervention group, there were significant (P motivated teachers. The comparison group did not show significant differences between the pre- and post-intervention times for any of the stages of behaviour. The intervention programme encouraged the students to make healthy lifestyle choices related to eating habits and physical activity behaviours.

  6. Comparison between group and personal rehabilitation for dementia in a geriatric health service facility: single-blinded randomized controlled study.

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    Tanaka, Shigeya; Honda, Shin; Nakano, Hajime; Sato, Yuko; Araya, Kazufumi; Yamaguchi, Haruyasu

    2017-05-01

    The aim of this study was to compare the effects of rehabilitation involving group and personal sessions on demented participants. This single-blinded randomized controlled trial included 60 elderly participants with dementia in a geriatric health service facility, or R oken. Staff members, who did not participate in the intervention, examined cognitive function, mood, communication ability, severity of dementia, objective quality of life, vitality, and daily behaviour. After a baseline assessment, participants were randomly divided into three groups: (i) group intervention; (ii) personal intervention; and (iii) control. The 1-h group intervention (3-5 subjects) and 20-min personal intervention (one staff member per participant) were performed twice a week for 12 weeks (24 total sessions). The cognitive rehabilitation programme consisted of reminiscence, reality orientation, and physical exercise, and it was based on five principles of brain-activating rehabilitation; (i) pleasant atmosphere; (ii) communication; (iii) social roles; (iv) praising; and (v) errorless support. Data were analyzed after the second assessment. Outcome measures were analyzed in 43 participants-14 in the control group, 13 in group intervention, and 16 in personal intervention. Repeated measure ancova showed a significant interaction for cognitive function score (Mini-Mental State Examination) between group intervention and controls ( F  = 5.535, P = 0.029). In the post-hoc analysis, group intervention showed significant improvement (P = 0.016). Global severity of dementia tended to improve (P = 0.094) in group intervention compared to control (Mann-Whitney U -test). There were no significant interactions or improvements for other measurements. Group rehabilitation for dementia is more effective for improving cognitive function and global severity of dementia than personal rehabilitation in Roken. © 2016 Japanese Psychogeriatric Society.

  7. Bobath or motor relearning programme? A comparison of two different approaches of physiotherapy in stroke rehabilitation: a randomized controlled study.

    Science.gov (United States)

    Langhammer, B; Stanghelle, J K

    2000-08-01

    To examine whether two different physiotherapy regimes caused any differences in outcome in rehabilitation after acute stroke. A double-blind study of patients with acute first-ever stroke. Sixty-one patients were consecutively included, block randomized into two groups, and stratified according to gender and hemiplegic site. Group 1 (33 patients) and group 2 (28 patients) had physiotherapy according to Motor Relearning Programme (MRP) and Bobath, respectively. The supplemental treatment did not differ in the two groups. The Motor Assessment Scale (MAS), the Sødring Motor Evaluation Scale (SMES), the Barthel ADL Index and the Nottingham Health Profile (NHP) were used. The following parameters were also registered: length of stay in the hospital, use of assistive devices for mobility, and the patient's accommodation after discharge from the hospital. Patients treated according to MRP stayed fewer days in hospital than those treated according to Bobath (mean 21 days versus 34 days, p = 0.008). Both groups improved in MAS and SMES, but the improvement in motor function was significantly better in the MRP group. The two groups improved in Barthel ADL Index without significant differences between the groups. However, women treated by MRP improved more in ADL than women treated by Bobath. There were no differences between the groups in the life quality test (NHP), use of assistive devices or accommodation after discharge from the hospital. The present study indicates that physiotherapy treatment using the MRP is preferable to that using the Bobath programme in the acute rehabilitation of stroke patients.

  8. Comparison of two picosecond lasers to a nanosecond laser for treating tattoos: a prospective randomized study on 49 patients.

    Science.gov (United States)

    Lorgeou, A; Perrillat, Y; Gral, N; Lagrange, S; Lacour, J-P; Passeron, T

    2018-02-01

    Q-switched nanosecond lasers demonstrated their efficacy in treating most types of tattoos, but complete disappearance is not always achieved even after performing numerous laser sessions. Picosecond lasers are supposed to be more efficient in clearing tattoos than nanosecond lasers, but prospective comparative data remain limited. To compare on different types of tattoos the efficacy of a nanosecond laser with two types of picosecond lasers. We conducted a prospective randomized study performed from December 2014 to June 2016 on adult patients with all types of tattoos. The tattoos were divided into two halves of equal size. After randomization, half of the tattoo was treated with a picosecond laser and the other half with a nanosecond laser. The evaluation was performed on standardized pictures performed before treatment and 2 months after the last session, by two physicians, not involved in the treatment, blinded on the type of treatments received. The main end point was a clearance above 75% of the tattoos. A total of 49 patients were included. Professional tattoos represented 85.7%, permanent make-up 8.2% and non-professional tattoo 6.1%. The majority were black or blue and 10.2% were polychromatic. No patient was lost during follow-up. A reduction of 75% or more of the colour intensity was obtained for 33% of the tattoos treated with the picosecond lasers compared to 14% with the nanosecond laser (P = 0.008). An improvement superior to 75% was obtained in 34% monochromic black or blue tattoos with the picosecond lasers compared to 9% for the nanosecond laser. Only one of the five polychromic tattoos achieved more than 75% of improvement with the two types of laser. Our results show a statistically significant superiority of the picosecond lasers compared to the nanosecond laser for tattoo clearance. However, they do not show better efficacy for polychromic tattoos and the difference in terms of side-effects was also minimal with a tendency of picosecond

  9. Comparison between Simulation-based Training and Lecture-based Education in Teaching Situation Awareness. A Randomized Controlled Study.

    Science.gov (United States)

    Lee Chang, Alfredo; Dym, Andrew A; Venegas-Borsellino, Carla; Bangar, Maneesha; Kazzi, Massoud; Lisenenkov, Dmitry; Qadir, Nida; Keene, Adam; Eisen, Lewis Ari

    2017-04-01

    Situation awareness has been defined as the perception of the elements in the environment within volumes of time and space, the comprehension of their meaning, and the projection of their status in the near future. Intensivists often make time-sensitive critical decisions, and loss of situation awareness can lead to errors. It has been shown that simulation-based training is superior to lecture-based training for some critical scenarios. Because the methods of training to improve situation awareness have not been well studied in the medical field, we compared the impact of simulation vs. lecture training using the Situation Awareness Global Assessment Technique (SAGAT) score. To identify an effective method for teaching situation awareness. We randomly assigned 17 critical care fellows to simulation vs. lecture training. Training consisted of eight cases on airway management, including topics such as elevated intracranial pressure, difficult airway, arrhythmia, and shock. During the testing scenario, at random times between 4 and 6 minutes into the simulation, the scenario was frozen, and the screens were blanked. Respondents then completed the 28 questions on the SAGAT scale. Sample items were categorized as Perception, Projection, and Comprehension of the situation. Results were analyzed using SPSS Version 21. Eight fellows from the simulation group and nine from the lecture group underwent simulation testing. Sixty-four SAGAT scores were recorded for the simulation group and 48 scores were recorded for the lecture group. The mean simulation vs. lecture group SAGAT score was 64.3 ± 10.1 (SD) vs. 59.7 ± 10.8 (SD) (P = 0.02). There was also a difference in the median Perception ability between the simulation vs. lecture groups (61.1 vs. 55.5, P = 0.01). There was no difference in the median Projection and Comprehension scores between the two groups (50.0 vs. 50.0, P = 0.92, and 83.3 vs. 83.3, P = 0.27). We found a significant, albeit

  10. Comparison of two extracorporeal shock wave therapy techniques for the treatment of painful subcalcaneal spur. A randomized controlled study.

    Science.gov (United States)

    Tornese, Davide; Mattei, Enrico; Lucchesi, Giampaolo; Bandi, Marco; Ricci, Gabriele; Melegati, Gianluca

    2008-09-01

    To describe and compare two extracorporeal shock wave therapy techniques for the treatment of painful subcalcaneal spur. Random assignment to two groups of treatment with two and eight months follow-up. The data were collected in outpatients. Forty-five subjects with a history of at least six months of heel pain were studied. Each subject received a three-session ultrasound-guided extracorporeal shock wave therapy (performed weekly). Perpendicular technique was used in group A (n=22, mean age 59.3 +/- 12 years) and tangential technique was used in group B (n= 23, mean age 58.8 +/- 12.3 years). Mayo Clinical Scoring System was used to evaluate each subject before the treatment and at two and eight months follow-up. Mayo Clinical Scoring System pretreatment scores were homogeneous between the groups (group A 55.2 +/-18.7; group B 53.5 +/- 20; P>0.05). In both groups there was a significant (Pwave therapy. The tangential technique was found to be better tolerated as regards treatment-induced pain, allowing higher energy dosages to be used.

  11. A Randomized, Double-Blind Pilot Study of Dose Comparison of Ramosetron to Prevent Chemotherapy-Induced Nausea and Vomiting

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    Ka-Rham Kim

    2015-01-01

    Full Text Available Purpose. This study was conducted to determine the optimal dose titration of ramosetron to prevent the Rhodes Index of Nausea, Vomiting, and Retching (RINVR. Methods. Patients treated with folic acid, 5-fluorouracil, and oxaliplatin were randomized into three groups (0.3 mg, 0.45 mg, and 0.6 mg ramosetron before chemotherapy. The pharmacokinetics and pharmacodynamics using RINVR were evaluated. Results. Seventeen, 15, and 18 patients received ramosetron at doses of 0.3 mg, 0.45 mg, and 0.6 mg, respectively. Tmax (h, Cmax (ng/mL, and AUClast (ng·h/mL were associated with dose escalation significantly, showing a reverse correlation with the RINVR during chemotherapy. Acute CINV was observed in four patients (22.2%, two patients (14.3%, and one (5.6% patient and a delayed CINV on day 7 was found in eight (47%, three (21.4%, and five (27.8% patients in each group. The complete response rate was increased with dose escalation (35.3%, 50.0%, and 72.2% in each group and also showed the tendency for decreasing moderate-to-severe CINV. Conclusions. This study shows a trend regarding the dose-response relationship for ramosetron to prevent CINV, including delayed emesis. It suggested that dose escalation should be considered in patients with CINV in a subsequent cycle of chemotherapy, and an individual approach using RINVR could be useful to monitor CINV.

  12. Comparison of granisetron and metoclopramide in the treatment of pain and emesis in migraine patients: A randomized controlled trial study

    Directory of Open Access Journals (Sweden)

    Hassan Amiri

    2017-06-01

    Full Text Available Objectives: One of the irritating features of migraine is emesis that can compromise taking oral medications. We designed this study to compare the effectiveness of granisetron and metoclopramide in reducing pain and treating emesis in migraine patients. Methods: We included a total of 148 patients with migraine headache presenting to two referral hospitals in a prospective, double-blinded randomized controlled trial. We compared the effect of granisetron (2 mg intravenous with metoclopramide (10 mg intravenous. Pain intensity and emesis episodes were recorded before drug administration, one, two and four 4 h after drug administration. Results: Of the 148 patients, 47 were male and 101 were female. 75 patients received granisetron and 73 metoclopramide. Mean pain intensity before the administration of the medications was 7.67 ± 1.30 in granisetron group and 7.68 ± 1.13 in metoclopramide group with an insignificant difference. Mean pain intensity at one, two, and 4 h after drug administration was 3.20 ± 1.37, 2.39 ± 1.28, and 1.31 ± 0.52 in granisetron group and 5.04 ± 1.77, 4.1 ± 1.8, and 1.56 ± 0.68 in metoclopramide group (P = 0.03. Mean emesis episodes before drug administration were 1.85 ± 0.81 and 1.80 ± 0.77 in granisetron and metoclopramide groups, respectively. These episodes were 1.33 ± 0.66, 0.25 ± 0.49, and 0.04 ± 0.19 in granisetron group and 1.38 ± 0.73, 0.21 ± 0.47, and 0.41 ± 0.19 in metoclopramide group at one, two, and 4 h after the drug administration (P = 0.7. Conclusion: To came in conclusion, compared to metoclopramide, granisetron is a better choice in acute migraine ATTACK because it decreases the patients' pain as well as their emesis. Keywords: Migraine, Headache, Granisetron, Metoclopramide, Pain

  13. Randomized comparison of the clinical outcome of single versus multiple arterial grafts: the ROMA trial-rationale and study protocol.

    Science.gov (United States)

    Gaudino, Mario; Alexander, John H; Bakaeen, Faisal G; Ballman, Karla; Barili, Fabio; Calafiore, Antonio Maria; Davierwala, Piroze; Goldman, Steven; Kappetein, Peter; Lorusso, Roberto; Mylotte, Darren; Pagano, Domenico; Ruel, Marc; Schwann, Thomas; Suma, Hisayoshi; Taggart, David P; Tranbaugh, Robert F; Fremes, Stephen

    2017-12-01

    The primary hypothesis of the ROMA trial is that in patients undergoing primary isolated non-emergent coronary artery bypass grafting, the use of 2 or more arterial grafts compared with a single arterial graft (SAG) is associated with a reduction in the composite outcome of death from any cause, any stroke, post-discharge myocardial infarction and/or repeat revascularization. The secondary hypothesis is that in these patients, the use of 2 or more arterial grafts compared with a SAG is associated with improved survival. The ROMA trial is a prospective, unblinded, randomized event-driven multicentre trial comprising at least 4300 subjects. Patients younger than 70 years with left main and/or multivessel disease will be randomized to a SAG or multiple arterial grafts to the left coronary system in a 1:1 fashion. Permuted block randomization stratified by the centre and the type of second arterial graft will be used. The primary outcome will be a composite of death from any cause, any stroke, post-discharge myocardial infarction and/or repeat revascularization. The secondary outcome will be all-cause mortality. The primary safety outcome will be a composite of death from any cause, any stroke and any myocardial infarction. In all patients, 1 internal thoracic artery will be anastomosed to the left anterior descending coronary artery. For patients randomized to the SAG group, saphenous vein grafts will be used for all non-left anterior descending target vessels. For patients randomized to the multiple arterial graft group, the main target vessel of the lateral wall will be grafted with either a radial artery or a second internal thoracic artery. Additional grafts for the multiple arterial graft group can be saphenous veins or supplemental arterial conduits. To detect a 20% relative reduction in the primary outcome, with 90% power at 5% alpha and assuming a time-to-event analysis, the sample size must include 845 events (and 3650 patients). To detect a 20% relative

  14. A comparison of random walks in dependent random environments

    NARCIS (Netherlands)

    Scheinhardt, Willem R.W.; Kroese, Dirk

    We provide exact computations for the drift of random walks in dependent random environments, including $k$-dependent and moving average environments. We show how the drift can be characterized and evaluated using Perron–Frobenius theory. Comparing random walks in various dependent environments, we

  15. Influence of Ventilation Strategies and Anesthetic Techniques on Regional Cerebral Oximetry in the Beach Chair Position: A Prospective Interventional Study with a Randomized Comparison of Two Anesthetics.

    Science.gov (United States)

    Picton, Paul; Dering, Andrew; Alexander, Amir; Neff, Mary; Miller, Bruce S; Shanks, Amy; Housey, Michelle; Mashour, George A

    2015-10-01

    Beach chair positioning during general anesthesia is associated with cerebral oxygen desaturation. Changes in cerebral oxygenation resulting from the interaction of inspired oxygen fraction (FIO2), end-tidal carbon dioxide (PETCO2), and anesthetic choice have not been fully evaluated in anesthetized patients in the beach chair position. This is a prospective interventional within-group study of patients undergoing shoulder surgery in the beach chair position that incorporated a randomized comparison between two anesthetics. Fifty-six patients were randomized to receive desflurane or total intravenous anesthesia with propofol. Following induction of anesthesia and positioning, FIO2 and minute ventilation were sequentially adjusted for all patients. Regional cerebral oxygenation (rSO2) was the primary outcome and was recorded at each of five set points. While maintaining FIO2 at 0.3 and PETCO2 at 30 mmHg, there was a decrease in rSO2 from 68% (SD, 12) to 61% (SD, 12) (P positioning. The combined interventions of increasing FIO2 to 1.0 and increasing PETCO2 to 45 mmHg resulted in a 14% point improvement in rSO2 to 75% (SD, 12) (P position. There was no significant interaction effect of the anesthetic at the study intervention points. Increasing FIO2 and PETCO2 resulted in a significant increase in rSO2 that overcomes desaturation in patients anesthetized in the beach chair position and that appears independent of anesthetic choice.

  16. Comparison of Treatment Effects and Allergic responses to stiff neck between Sweet Bee Venom and Bee Venom Pharmacopuncture (A pilot study, Double blind, Randomized Controlled Clinical Trail

    Directory of Open Access Journals (Sweden)

    Kyoung-hee Lee

    2008-12-01

    Full Text Available Objective : The purpose of this study is to investigate the difference of treatment effects and allergic responses to stiff neck between Bee Venom Pharmacopuncture and Sweet Bee Venom Pharmacopuncture. Methods : Forty one patients who felt stiff neck were randomly divided into two groups, a Bee Venom Pharmacopuncture group(group Ⅰ and a Sweet Bee Venom Pharmacopuncture group(group Ⅱ. Evaluations of the treatment effects were made before and after a treatment using Visual Analog Scale(VAS, Neck Disability Index(NDI, Clinical Evaluation Grade(CEG. The comparison of allergic responses was measured with VAS. The obtained data were analyzed and compared with SPSS. Results : The group Ⅰ and group Ⅱ showed significant improvement(p<0.05 according to the VAS, NDI, CEG. And the differences between the two groups were insignificant according to VAS, NDI, CEG. But allergic responses such as localized edema, localized itching were significantly lower in group Ⅱ than group Ⅰ. Conclusions : It seems that there are no big different treatment effects between the two groups. Sweet Bee Venom Pharmacopuncture appears to be more effective measurement against allergic reactions than the Bee Venom Pharmacopuncture. Further studies are needed for the comparison of Bee Venom Pharmacopuncture and Sweet Bee Venom Pharmacopuncture.

  17. A Comparison of Web-based and Small-Group Palliative and End-of-Life Care Curricula: A Quasi-Randomized Controlled Study at One Institution

    Science.gov (United States)

    Day, Frank C.; Srinivasan, Malathi; Der-Martirosian, Claudia; Griffin, Erin; Hoffman, Jerome R.; Wilkes, Michael S.

    2014-01-01

    Purpose Few studies have compared the effect of web-based eLearning versus small-group learning on medical student outcomes. Palliative and end-of-life (PEOL) education is ideal for this comparison, given uneven access to PEOL experts and content nationally. Method In 2010, the authors enrolled all third-year medical students at the University of California, Davis School of Medicine into a quasi-randomized controlled trial of web-based interactive education (eDoctoring) compared to small-group education (Doctoring) on PEOL clinical content over two months. All students participated in three 3-hour PEOL sessions with similar content. Outcomes included a 24-item PEOL-specific self-efficacy scale with three domains (diagnosis/treatment [Cronbach’s alpha = 0.92, CI: 0.91–0.93], communication/prognosis [alpha = 0.95; CI: 0.93–0.96], and social impact/self-care [alpha = 0.91; CI: 0.88–0.92]); eight knowledge items; ten curricular advantage/disadvantages, and curricular satisfaction (both students and faculty). Results Students were randomly assigned to web-based eDoctoring (n = 48) or small-group Doctoring (n = 71) curricula. Self-efficacy and knowledge improved equivalently between groups: e.g., prognosis self-efficacy, 19%; knowledge, 10–42%. Student and faculty ratings of the web-based eDoctoring curriculum and the small group Doctoring curriculum were equivalent for most goals, and overall satisfaction was equivalent for each, with a trend towards decreased eDoctoring student satisfaction. Conclusions Findings showed equivalent gains in self-efficacy and knowledge between students participating in a web-based PEOL curriculum, in comparison to students learning similar content in a small-group format. Web-based curricula can standardize content presentation when local teaching expertise is limited, but may lead to decreased user satisfaction. PMID:25539518

  18. A comparison of random walks in dependent random environments

    NARCIS (Netherlands)

    Scheinhardt, Willem R.W.; Kroese, Dirk

    2015-01-01

    Although the theoretical behavior of one-dimensional random walks in random environments is well understood, the actual evaluation of various characteristics of such processes has received relatively little attention. This paper develops new methodology for the exact computation of the drift in such

  19. Comparison of Bupivacaine Plus Magnesium Sulfate and Ropivacaine Plus Magnesium Sulfate Infiltration for Postoperative Analgesia in Patients Undergoing Lumbar Laminectomy: A Randomized Double-blinded Study.

    Science.gov (United States)

    Hazarika, Rajib; Parua, Samit; Choudhury, Dipika; Barooah, Rajesh Kumar

    2017-01-01

    The objective of this study was to assess and compare the analgesic duration of local infiltration of bupivacaine plus magnesium sulfate and ropivacaine plus magnesium sulfate for postoperative analgesia in patients undergoing lumbar laminectomy. A randomized, prospective, double-blinded single hospital, comparative study. Sixty adult patients of the American Society of Anesthesiologists physical Status I and II were randomly allocated into two Groups BM and RM, comprising 30 and 31 patients. Postlumbar laminectomy, the study drug was locally infiltrated into the paravertebral muscles on either side before skin closure. Group BM was given 20 ml of 0.25% bupivacaine combined with 500 mg of magnesium sulfate (constituted with normal saline [NS]), and Group RM was given 20 ml of 0.25% ropivacaine combined with 500 mg of magnesium sulfate (constituted with NS). Postoperative visual analog scale pain score was assessed hourly for the first 24 h postoperatively. Duration of postoperative analgesia, rescue analgesia consumption and side effects were also recorded. Comparison of data between the groups was done with SPSS 21.0© using independent t -test, Chi-square test, and Mann-Whitney U-test accordingly. P <0.05 was considered statistically significant. Time to first analgesic consumption was significantly longer in Group BM (7.3 ± 0.46 h) compared to Group RM (6.6 ± 0.69 h) ( P < 0.05). The consumption of nalbuphine rescue analgesic was significantly higher in Group RM (15.33 ± 5.07 mg) compared to Group BM (12 ± 4.07 mg) ( P < 0.05). Wound infiltration with bupivacaine and magnesium sulfate compared to ropivacaine and magnesium sulfate provided longer duration of postoperative analgesia and significantly reduced postoperative opioid consumption in patients undergoing lumbar laminectomy.

  20. A direct comparison of efficacy between desloratadine and rupatadine in seasonal allergic rhinoconjunctivitis: a randomized, double-blind, placebo-controlled study.

    Science.gov (United States)

    Lukat, Kf; Rivas, P; Roger, A; Kowalski, Ml; Botzen, U; Wessel, F; Sanquer, F; Agache, I; Izquierdo, I

    2013-01-01

    H1-antihistamines are recommended as the first-line symptomatic treatment of allergic rhinitis. The objective of this study was to evaluate the effects of rupatadine (RUP) versus desloratadine (DES) in subjects with seasonal allergic rhinitis (SAR). To assess the efficacy and safety of RUP in SAR in comparison with placebo (PL) and DES. A randomized, double-blind, multicenter, international, and PL-controlled study was carried out. The main selection criteria included SAR patients over 12 years old with a positive prick test to a relevant seasonal allergen for the geographic area. Symptomatic patients at screening with a nasal symptom sum score of ≥6 points (nasal discharge, nasal obstruction, sneezing, and nasal pruritus), a non-nasal score of ≥3 points (ocular pruritus, ocular redness, and tearing eyes), and a rhinorrhea score of ≥2 points with laboratory test results and electrocardiography within acceptable limits were included in the study. Change from baseline in the total symptom-score (T7SS) over the 4-week treatment period (reflective evaluation) was considered the primary efficacy variable. Secondary efficacy measures included total nasal symptom score (T4NSS) and conjunctival symptom score (T3NNSS), both of which are reflective and instantaneous evaluations. Furthermore questions related to quality of life (eg, sleep disturbances or impairment of daily activities) have also been evaluated. Safety was assessed according to adverse events reported, as well as laboratory and electrocardiography controls. A total of 379 patients were randomized, of which 356 were included and allocated to PL (n = 122), RUP (n = 117), or DES (n = 117). Mean change of T7SS over the 4-week treatment period was significantly reduced in the RUP (-46.1%, P = 0.03) and DES (-48.9%, P = 0.01) groups, compared with PL. Similarly, RUP and DES were comparable and significantly superior to PL for all secondary endpoints, including nasal and conjunctival symptoms and patients' and

  1. Comparison of Sleep Latency and Number of SOREMPs in the Home and Hospital With a Modified Multiple Sleep Latency Test: A Randomized Crossover Study.

    Science.gov (United States)

    Beiske, Kornelia K; Sand, Trond; Rugland, Eyvind; Stavem, Knut

    2017-05-01

    Comparison of mean sleep latencies and number of sleep-onset rapid eye movement periods (SOREMPs) between modified multiple sleep latency test (MSLT) performed in the unattended home and in-hospital laboratory setting. A randomized crossover single-blinded design. Thirty-four subjects referred to MSLT for suspected hypersomnia or narcolepsy were included. Participants were randomized to perform modified MSLT in the unattended home or in the hospital first. Scores in the two settings were compared using Wilcoxon signed-rank test or exact McNemar test. Agreement between home and hospital categorized mean sleep latency and number of SOREMPs was assessed using simple kappa (κ) and proportion agreement. Agreement between home and hospital mean sleep latency was assessed using a Bland-Altman plot and an intraclass correlation coefficient. There was no difference between home and hospital assessment of mean sleep latency (P = 0.86). Two or more SOREMPs were found more frequently on modified MSLTs performed at home compared with those at the hospital (7 and 2, respectively; P = 0.025). Agreement was moderate for categorized sleep latency (κ = 0.53) and fair for categorized SOREMPs (κ = 0.39) in the 2 settings. Analysis of mean sleep latency using intraclass correlation coefficient showed a very good agreement between the two settings. Group mean sleep latency for home modified MSLTs seems to be reliable compared with that for the attended sleep-laboratory setting. Higher rate of SOREMP in the unattended home suggests that napping in a familiar environment facilitates the transition into REM sleep. Further studies are needed to assess the normal limit, sensitivity, and specificity for SOREMP at home before the clinical utility of home-based napping can be determined.

  2. Effects and safety of daily ingestion of plum extract on blood pressure: randomized, double-blinded, placebo-controlledparallelgroup comparison study

    Directory of Open Access Journals (Sweden)

    Mie Nishimura

    2017-11-01

    Full Text Available Background: Hypertension is an increasing health issue in Japan. Plums are widely consumed in Japan and are reported to have various health benefits, including improvements to blood flow. However, clinical trials investigating the effects of plum extract on blood pressure have not yet been conducted. Therefore, we evaluated the effects and safety of plum extract on blood pressure in this randomized, double-blinded, and placebo-controlled parallel group comparison study. Methods: Seventy-four healthy Japanese subjects with systolic blood pressure (SBP ≥130 and <160 mmHg were randomly divided into test and placebo groups. Subjects were given either plum extract-processed food (3.0 g of plum extract, containing 30 mg of mumefural and 1.119 g of citric acid or placebo food daily for 12 weeks. Physical examinations, blood measurements, and medical interviews were performed at weeks 0, 4, 8, and 12 and at 2 weeks after the intake period. Results: SBP and diastolic blood pressure (DBP did not significantly differ between the groups. However, in subjects with grade I hypertension, DBP was significantly lower in the active test food group than in the placebo food group at week 12 and at 2 weeks after the intake period. An exploratory subgroup analysis revealed that plum extract improved DBP in subjects with normal to high obesity/class I obesity at week 12. Moreover, plum extract had positive effects on fatigue and bowel movements as determined by visual analog scale questionnaire evaluation. No abnormal changes or severe adverse events were observed in the physical examinations, blood measurements, or medical interviews in this trial. Conclusion: These results suggest that plum extract is safe for long-term intake and improves DBP in subjects with grade I hypertension.

  3. Comparison of Early Results and Complications between Multi-and Single-Port Sleeve Gastrectomy: A Randomized Clinical Study

    Directory of Open Access Journals (Sweden)

    Seyed Vahid Hosseini

    2017-05-01

    Full Text Available Background: In recent years, laparoscopic sleeve gastrectomy (LSG has become more acceptable for obese patients. Single-port sleeve gastrectomy (SPSG is more popular since each abdominal incision carries the risk of bleeding, hernia, and internal organ injury as well as exponentially affecting cosmesis. This cross-sectional study aimed at comparing multi-port sleeve gastrectomy (MPSG and SPSG in terms of their early results and complications. Methods: Out of129 obese patients candidated for LSG, 102 patients were assigned to 2 groups of SPSG and MPSG. Complications and demographic data such as body mass index (BMI, age, gender, operation time, and hospital stay were measured. All surgeries were carried out between2013 and 2015 in Shiraz, Iran. Data analysis was performed using SPSS, version 16 for Windows (SPSS Inc., Chicago, IL. The continuous and categorical variables were compared using the Student t-test and the Chi-square test or the Fisher exact test, respectively. Results: The patients’ data from both groups were similar in terms of age, intraoperative and postoperative bleeding volume, and length of hospital stay. Mean BMI was 42.8±0.7 in the SPSG group and 45.3±1.2 in the MPSG group. Duration of surgery was significantly lower in the SPSG group (P<0.001. Only 1 patient from the SPSG group and 5 patients from the MPSG group had bleeding as an early complication. Conclusion: The differences in each complication between the groups were not statistically significant. SPSG seems to be safe and is the same as MPSG in terms of major postoperative complications. Trial Registration Number: IRCT201512229936N12

  4. Comparison of the effects of magnesium sulphate and dexmedetomidine on surgical vision quality in endoscopic sinus surgery: randomized clinical study

    Directory of Open Access Journals (Sweden)

    Akcan Akkaya

    2014-12-01

    Full Text Available Background and objectives: Even a small amount of bleeding during endoscopic sinus surgery can corrupt the endoscopic field and complicate the procedure. Various techniques, including induced hypotension, can minimize bleeding during endoscopic sinus surgery. The aim of this study was to compare the surgical vision quality, haemodynamic parameters, postoperative pain, and other effects of magnesium, a hypotensive agent, with that of dexmedetomidine, which was initially developed for short-term sedation in the intensive care unit but also is an alpha 2 agonist sedative. Method: 60 patients between the ages of 18 and 45 years were divided into either the magnesium group (Group M or the dexmedetomidine group (Group D. In Group M, magnesium sulphate was given at a pre-induction loading dose of 50 mg kg−1 over 10 min and maintained at 15 mg kg−1 h−1; in Group D, dexmedetomidine was given at 1 mcg kg−1 10 min before induction and maintained at 0.6 mcg kg−1 h−1. Intraoperatively, the haemodynamic and respiratory parameters and 6-point intraoperative surgical field evaluation scale were recorded. During the postoperative period, an 11-point numerical pain scale, the Ramsay sedation scale, the nausea/vomiting scale, the adverse effects profile, and itching parameters were noted. Results: Group D showed a significant decrease in intraoperative surgical field evaluation scale scale score and heart rate. The average operation time was 50 min, and Group M had a higher number of prolonged surgeries. No significant difference was found in the other parameters. Conclusions: Due to its reduction of bleeding and heart rate in endoscopic sinus surgery and its positive impacts on the duration of surgery, we consider dexmedetomidine to be a good alternative to magnesium.

  5. Experimental comparison of support vector machines with random ...

    Indian Academy of Sciences (India)

    dient method, support vector machines, and random forests to improve producer accuracy and overall classification accuracy. The performance comparison of these classifiers is valuable for a decision maker ... ping, surveillance system, resource management, tracking ... rocks, water bodies, and anthropogenic elements,.

  6. Comparison of the effectiveness of orthotic intervention, kinesiotaping, and paraffin treatments in patients with carpal tunnel syndrome: A single-blind and randomized controlled study.

    Science.gov (United States)

    Mansiz Kaplan, Basak; Akyuz, Gulseren; Kokar, Serdar; Yagci, Ilker

    2018-02-17

    The aim of the study was to compare different conservative treatments in patients with carpal tunnel syndrome (CTS). A single-blind randomized controlled study. Patients (n = 169) diagnosed with mild or moderate CTS were screened; 110 met study requirements. The patients were randomized into 3 groups. The control (CON) comparison provided to all patients was a fabricated night orthotic which held the wrist in a neutral position. The second group received adjunctive kinesiotaping (KIN) and the third group received paraffin (PARA). All patients were evaluated clinically, electrophysiologically, and ultrasonographically before treatment and at 3 weeks, 3 months, and 6 months. There were 36 patients in CON, 37 in KIN, and 37 in PARA. Pain reduction in KIN was better than the other groups at 3 weeks (mean difference [MD] in CON 2.4 ± 2.5, KIN 3.7 ± 2.0, PARA 2.7 ± 2.3; P < .01) and 6 months (MD in CON 3.4 ± 3.0, KIN 4.9 ± 3.1, PARA 3.7 ± 2.9; P < .05). KIN pain reduction was better than CON at 3 months (MD in CON 3.8 ± 2.8, KIN 5.0 ± 2.5; P < .05). Reduction of the cross-sectional area of median nerve at the level of radioulnar joint was greater for KIN than CON at 3 weeks (MD in CON 0.0 ± 0.5, KIN 0.3 ± 0.7; P < .01) than PARA at 3 months (MD in KIN 0.3 ± 0.8, PARA 0.0 ± 0.8; P < .05) and both groups at 6 months (MD in CON 0.1 ± 0.8, KIN 0.5 ± 0.9, PARA 0.0 ± 1.0 P < .05). Adding KIN to night use of an orthotic was more effective in achieving symptomatic and structural improvements than either the orthotic alone or adjunctive use of paraffin in patients with mild and moderate CTS. Copyright © 2018 Hanley & Belfus. Published by Elsevier Inc. All rights reserved.

  7. An experimental comparison of triggered and random pulse train uncertainties

    International Nuclear Information System (INIS)

    Henzlova, Daniela; Menlove, Howard O.; Swinhoe, Martyn T.

    2010-01-01

    response) have used only one of the two analysis methods for the nuclear material assay. The aim of this study is to provide a systematic comparison of the precision of the measured S, D, T rates and 240 Pu effective mass obtained using the above mentioned pulse train sampling techniques. In order to perform this task, a LANL developed list mode based data acquisition system is used, where the entire pulse train is recorded and subsequently analyzed. The list mode acquisition brings an essential advantage for this type of comparison, since the very same pulse train can be analyzed using signal-triggered as well as randomly triggered counting gates. The aim of this study is not only to compare the precision of signal-triggered versus random triggered sampling techniques, but also to investigate the influence of fast accidental sampling on the precision of signal-triggered results. In addition the different random sampling techniques used in safeguards are investigated. For this purpose we implement two types of random sampling - non-overlapping gates (Feynrnan approach) and periodic overlapping gates (fast accidentals). In the following sections the equations utilized in the pulse train analysis are described, experimental setup and measurement techniques are discussed and finally the results are summarized and discussed.

  8. Comparison of Address-based Sampling and Random-digit Dialing Methods for Recruiting Young Men as Controls in a Case-Control Study of Testicular Cancer Susceptibility

    OpenAIRE

    Clagett, Bartholt; Nathanson, Katherine L.; Ciosek, Stephanie L.; McDermoth, Monique; Vaughn, David J.; Mitra, Nandita; Weiss, Andrew; Martonik, Rachel; Kanetsky, Peter A.

    2013-01-01

    Random-digit dialing (RDD) using landline telephone numbers is the historical gold standard for control recruitment in population-based epidemiologic research. However, increasing cell-phone usage and diminishing response rates suggest that the effectiveness of RDD in recruiting a random sample of the general population, particularly for younger target populations, is decreasing. In this study, we compared landline RDD with alternative methods of control recruitment, including RDD using cell-...

  9. Comparison of the Effects of Daily Single-Dose Use of Flurbiprofen, Diclofenac Sodium, and Tenoxicam on Postoperative Pain, Swelling, and Trismus: A Randomized Double-Blind Study.

    Science.gov (United States)

    Kaplan, Volkan; Eroğlu, Cennet Neslihan

    2016-10-01

    The aim of the present study was to compare the effects of daily single-dose use of flurbiprofen, diclofenac sodium, and tenoxicam on pain, swelling, and trismus that occur after surgical extraction of impacted wisdom teeth using local anesthesia. The present study included 3 groups with 30 patients in each group. Those volunteering to participate in this double-blind randomized study (n = 90) were selected from a patient population with an indication for extraction of impacted wisdom teeth. Group 1 patients received 200 mg flurbiprofen, group 2 patients received 100 mg diclofenac sodium, and group 3 patients received 20 mg tenoxicam. All doses were once a day, starting preoperatively. Pain was evaluated postoperatively at 1, 2, 3, 6, 8, and 24 hours and at 2 and 7 days using a visual analog scale (VAS). For comparison with the preoperative measurements, the patients were invited to postoperative follow-up visits 2 and 7 days after extraction to evaluate for swelling and trismus. The statistical analysis was performed using descriptive statistics in SAS, version 9.4 (SAS Institute, Cary, NC), software. Statistical analysis of the pain, swelling, and trismus data was performed using the Kruskal-Wallis, Dunn, and Wilcoxon-Mann-Whitney U tests. The statistical level of significance was accepted at P = .05 and power of 0.80. Clinically, tenoxicam showed better analgesic and anti-inflammatory efficacy compared with diclofenac sodium and, in particular, flurbiprofen. Although the VAS scores in the evaluation of pain showed statistically significant differences at 2 days, no statistically significant difference was found for swelling and trismus. Our study evaluated the analgesic and anti-inflammatory effects with a daily single dose of flurbiprofen, diclofenac sodium, and tenoxicam. Daily 20 mg tenoxicam can be accepted as an adequate and safe option for patients after a surgical procedure. Copyright © 2016 American Association of Oral and Maxillofacial

  10. A comparison of Percutaneous femoral access in Endovascular Repair versus Open femoral access (PiERO): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Vierhout, Bastiaan P; Saleem, Ben R; Ott, Alewijn; van Dijl, Jan Maarten; de Kempenaer, Ties D van Andringa; Pierie, Maurice E N; Bottema, Jan T; Zeebregts, Clark J

    2015-09-14

    Access for endovascular repair of abdominal aortic aneurysms (EVAR) is obtained through surgical cutdown or percutaneously. The only devices suitable for percutaneous closure of the 20 French arteriotomies of the common femoral artery (CFA) are the Prostar(™) and Proglide(™) devices (Abbott Vascular). Positive effects of these devices seem to consist of a lower infection rate, and shorter operation time and hospital stay. This conclusion was published in previous reports comparing techniques in patients in two different groups (cohort or randomized). Access techniques were never compared in one and the same patient; this research simplifies comparison because patient characteristics will be similar in both groups. Percutaneous access of the CFA is compared to surgical cutdown in a single patient; in EVAR surgery, access is necessary in both groins in each patient. Randomization is performed on the introduction site of the larger main device of the endoprosthesis. The contralateral device of the endoprosthesis is smaller. When we use this type of randomization, both groups will contain a similar number of main and contralateral devices. Preoperative nose cultures and perineal cultures are obtained, to compare colonization with postoperative wound cultures (in case of a surgical site infection). Furthermore, patient comfort will be considered, using VAS-scores (Visual analog scale). Punch biopsies of the groin will be harvested to retrospectively compare skin of patients who suffered a surgical site infection (SSI) to patients who did not have an SSI. The PiERO trial is a multicenter randomized controlled clinical trial designed to show the consequences of using percutaneous access in EVAR surgery and focuses on the occurrence of surgical site infections. NTR4257 10 November 2013, NL44578.042.13.

  11. Prospective Randomized Controlled Comparison of Caudal ...

    African Journals Online (AJOL)

    Background: Bupivacaine and ropivacaine are commonly used agents for caudal anesthesia in pediatric patients. Several studies have shown different motor and cardiovascular effects of two drugs. Aim: The primary objective of this study was to evaluate the efficacy of both drugs and secondary objective was to compare ...

  12. Comparison of topical ropivacaine with and without ketamine on post-surgical pain in children undergoing tonsillectomy: a randomized controlled double-blind study.

    Science.gov (United States)

    Hong, Boohwi; Lim, Chae Seong; Kim, Yoon-Hee; Lee, Jung Un; Kim, Yong Min; Jung, Choonho; Jo, Yumin

    2017-08-01

    Tonsillectomy in pediatric patients may cause severe postoperative pain. Topical local anesthetics are an easy and safe way to control post-tonsillectomy pain, but there is no benefit during the early postoperative stage. Topical ketamine shows a good effect on early stage postoperative pain. We compared the effect of topical ropivacaine with and without ketamine on post-tonsillectomy pain. Patients aged 3-7 years undergoing tonsillectomy were selected to participate in the study. Our study was performed in a randomized, placebo-controlled, double-blind manner. Patients were randomly assigned to one of two groups using computer-generated random numbers. The researchers who assessed the pain score, the caregivers, and the patient were blinded to group assignment. One group received topical ropivacaine with saline (RS group) and the other group received topical ropivacaine with 20 mg ketamine (RK group) on the tonsillar bed. Pain scores using the modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS) at 15 min and 30 min, and at 1, 2, 4, 8, 16 and 24 h were recorded. Rescue analgesic requirement and complications were also recorded. A total of 66 patients were randomly assigned to the RS group (n = 33) and the RK group (n = 33). The mCHEOPS scores were significantly lower in the RK group at 15 min (P = 0.046). The mCHEOPS scores of the two groups decreased with time, but there was no intergroup interaction. The RS group received more analgesics until 1 h after surgery and the RK group received more analgesics during 1-24 h after surgery. There were no differences in adverse outcomes. Topical ropivacaine with ketamine can reduce immediate postoperative pain and analgesic requirement better than ropivacaine alone.

  13. A Comparison of Radiofrequency-Based Microtenotomy and Arthroscopic Release of the Extensor Carpi Radialis Brevis Tendon in Recalcitrant Lateral Epicondylitis: A Prospective Randomized Controlled Study.

    Science.gov (United States)

    Lee, Jae-Hoo; Park, In; Hyun, Hwan-Sub; Shin, Sang-Jin

    2018-01-20

    To compare the clinical effects of radiofrequency (RF)-based microtenotomy and arthroscopic release of the extensor carpi radialis brevis (ECRB) tendon in patients with recalcitrant lateral epicondylitis through a prospective randomized controlled study. A total of 46 patients were randomly assigned to receive arthroscopic release (group A, 24 patients) or RF-based microtenotomy (group B, 22 patients). The visual analog scale (VAS) score for pain, flexion-extension arc, operation time, Disabilities of the Arm, Shoulder, and Hand questionnaire (DASH), Mayo Elbow Performance Score (MEPS), and grip power of groups A and B were compared during the recovery phases for up to 2 postoperative years. Both groups showed statistically significant functional improvement compared with their preoperative grip strength and DASH, VAS, and MEPS scores at 2 years after surgery (P lateral epicondylitis provided clinical outcomes comparable with those from arthroscopic release of ECRB tendon during the recovery phase. RF-based microtenotomy is considered as one of the surgical procedures for treating recalcitrant lateral epicondylitis, with the advantages of reliable elbow functional restoration and significantly shorter operation time. Level I, prospective randomized trial. Copyright © 2017 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

  14. The efficacy of electroacupuncture for the treatment of simple female stress urinary incontinence - comparison with pelvic floor muscle training: study protocol for a multicenter randomized controlled trial.

    Science.gov (United States)

    Su, Tongsheng; Zhou, Jing; Liu, Zhishun; Chen, Yuelai; Zhang, Wei; Chu, Haoran; Luo, Qiong; Lu, Jin; An, Junming; Liu, Baoyan

    2015-02-08

    Previous research has shown that electroacupuncture therapy has a potential therapeutic effect for simple female stress urinary incontinence. In this study, pelvic floor muscle training, the first-line treatment for stress urinary incontinence in women based on meta-analysis of numerous randomized control trials and recommended by international clinical practice, is used as a control group to demonstrate whether electroacupuncture therapy is a better method for female stress urinary incontinence. A randomized controlled trial has been designed to evaluate the therapeutic benefit of electroacupuncture for female stress urinary incontinence compared with pelvic floor muscle training. The safety of electroacupuncture and patient compliance will also be evaluated. Untoward reaction to the electroacupuncture, including a broken needle, fainting on acupuncture, or pain during acupuncture, will be recorded and the therapy will be stopped if an untoward reaction occurs. After we have received full ethical approval and patient consent, participants will be randomized to receive a series of 24 electroacupuncture or pelvic floor muscle training interventions. The frequency and amount of leakage will be measured as the primary outcome parameters. Secondary outcome parameters include the 1-hour pad test, the short-form of the International Consultation on Incontinence Questionnaire, patient subjective effectiveness evaluation, weekly usage of pad, and usage of specialty therapy for female stress urinary incontinence. This trial will help to determine whether electroacupuncture is a more effective treatment than pelvic floor muscle training for patients with female stress urinary incontinence. ClinicalTrials.gov NCT01940432 (12 September 2013).

  15. Comparison of group-based outpatient physiotherapy with usual care after total knee replacement: a feasibility study for a randomized controlled trial.

    Science.gov (United States)

    Artz, Neil; Dixon, Samantha; Wylde, Vikki; Marques, Elsa; Beswick, Andrew D; Lenguerrand, Erik; Blom, Ashley W; Gooberman-Hill, Rachael

    2017-04-01

    To evaluate the feasibility of conducting a randomized controlled trial comparing group-based outpatient physiotherapy with usual care in patients following total knee replacement. A feasibility study for a randomized controlled trial. One secondary-care hospital orthopaedic centre, Bristol, UK. A total of 46 participants undergoing primary total knee replacement. The intervention group were offered six group-based exercise sessions after surgery. The usual care group received standard postoperative care. Participants were not blinded to group allocation. Feasibility was assessed by recruitment, reasons for non-participation, attendance, and completion rates of study questionnaires that included the Lower Extremity Functional Scale and Knee Injury and Osteoarthritis Outcome Score. Recruitment rate was 37%. Five patients withdrew or were no longer eligible to participate. Intervention attendance was high (73%) and 84% of group participants reported they were 'very satisfied' with the exercises. Return of study questionnaires at six months was lower in the usual care (75%) than in the intervention group (100%). Mean (standard deviation) Lower Extremity Functional Scale scores at six months were 45.0 (20.8) in the usual care and 57.8 (15.2) in the intervention groups. Recruitment and retention of participants in this feasibility study was good. Group-based physiotherapy was acceptable to participants. Questionnaire return rates were lower in the usual care group, but might be enhanced by telephone follow-up. The Lower Extremity Functional Scale had high responsiveness and completion rates. Using this outcome measure, 256 participants would be required in a full-scale randomized controlled trial.

  16. Comparison of analgesic efficacy of levobupivacaine, levobupivacaine and clonidine, and levobupivacaine and dexmedetomidine in wound infiltration technique for abdominal surgeries: A prospective randomized controlled study

    Directory of Open Access Journals (Sweden)

    B Jyothi

    2017-01-01

    Full Text Available Background: This study was designed to evaluate the postoperative analgesic efficacy of levobupivacaine (L alone and its combination with clonidine (C or dexmedetomidine (D in wound infiltration technique for abdominal surgeries. Materials and Methods: After ethical committee approval, a double-blind randomized controlled study was conducted on 90 patients (power of study 80%, physical status American Society of Anesthesiologists Grade I and II, aged 18–60 years scheduled for abdominal surgeries over 1 year duration. A standard general anesthetic technique was used. Patients were randomly allocated into three groups, by computer-generated random number table. Patients received wound infiltration during wound closure. Group L received 29 ml of 0.25% levobupivacaine plus 1 ml 0.9% normal saline, Group LC received 29 ml of 0.25% levobupivacaine with 1 ml (3 mcg/kg clonidine, and Group LD received 29 ml of 0.25% levobupivacaine with 1 ml (2 mcg/kg dexmedetomidine. Postoperative rescue analgesia was provided with injection tramadol. Statistical analysis for duration of analgesia was determined by one-way analysis of variance and side effects by Chi-square test. Results: The total duration of analgesia in LD group was 23.4 h, when compared to LC group 20.9 h and L group 11.65 h (P = 0.0001 with excellent to good quality of analgesia in adjuvant group (P < 0.001 and incidence of minimal side effects such as sedation, nausea, and vomiting. Conclusion: Clonidine and dexmedetomidine were the effective adjuvants to levobupivacaine for single shot wound infiltration analgesic technique; however, dexmedetomidine was found to be superior to clonidine.

  17. Comparison of treatment effect estimates of non-vitamin K antagonist oral anticoagulants versus warfarin between observational studies using propensity score methods and randomized controlled trials

    International Nuclear Information System (INIS)

    Li, Guowei; Holbrook, Anne; Jin, Yanling; Zhang, Yonghong; Levine, Mitchell A. H.; Mbuagbaw, Lawrence; Witt, Daniel M.; Crowther, Mark; Connolly, Stuart; Chai-Adisaksopha, Chatree; Wan, Zhongxiao; Cheng, Ji; Thabane, Lehana

    2016-01-01

    Emerging observational studies using propensity score (PS) methods assessed real-world comparative effectiveness of non-vitamin K antagonist oral anticoagulants (NOACs) versus warfarin in patients with non-valvular atrial fibrillation (AF). We aimed to compare treatment effect estimates of NOACs between PS studies and randomized controlled trials (RCTs). Electronic databases and conference proceedings were searched systematically. Primary outcomes included stroke or systemic embolism (SE) and major bleeding. A random-effects meta-analysis was performed to synthesize the data by pooling the PS- and RCT-derived hazard ratios (HRs) separately. The ratio of HRs (RHR) from the ratio of PS-derived HRs relative to RCT-derived HRs was used to determine whether there was a difference between estimates from PS studies and RCTs. There were 10 PS studies and 5 RCTs included for analysis. No significant difference of treatment effect estimates between the PS studies and RCTs was observed: RHR 1.11, 95 % CI 0.98–1.23 for stroke or SE; RHR 1.07, 95 % CI 0.87–1.34 for major bleeding. A significant association between NOACs and risk of stroke or SE was observed: HR 0.88, 95 % CI 0.83–0.94 for the PS studies; HR 0.79, 95 % CI 0.72–0.87 for the RCTs. However, no relationship between NOACs and risk of major bleeding was found: HR 0.91, 95 % CI 0.79–1.05 for the PS studies; HR 0.85, 95 % CI 0.73–1.00 for the RCTs. In this study, treatment effect estimates of NOACs versus warfarin in patients with non-valvular AF from PS studies are found to be in agreement with those from RCTs.

  18. The comparison between limited open carpal tunnel release using direct vision and tunneling technique and standard open carpal tunnel release: a randomized controlled trial study.

    Science.gov (United States)

    Suppaphol, Sorasak; Worathanarat, Patarawan; Kawinwongkovit, Viroj; Pittayawutwinit, Preecha

    2012-04-01

    To compare the operative outcome of carpal tunnel release between limited open carpal tunnel release using direct vision and tunneling technique (group A) with standard open carpal tunnel release (group B). Twenty-eight patients were enrolled in the present study. A single blind randomized control trial study was conducted to compare the postoperative results between group A and B. The study parameters were Levine's symptom severity and functional score, grip and pinch strength, and average two-point discrimination. The postoperative results between two groups were comparable with no statistical significance. Only grip strength at three months follow up was significantly greater in group A than in group B. The limited open carpal tunnel release in the present study is effective comparable to the standard open carpal tunnel release. The others advantage of this technique are better cosmesis and improvement in grip strength at the three months postoperative period.

  19. Comparison of frovatriptan plus dexketoprofen (25 mg or 37.5 mg) with frovatriptan alone in the treatment of migraine attacks with or without aura: a randomized study.

    Science.gov (United States)

    Tullo, Vincenzo; Valguarnera, Fabio; Barbanti, Piero; Cortelli, Pietro; Sette, Giuliano; Allais, Gianni; d'Onofrio, Florindo; Curone, Marcella; Zava, Dario; Pezzola, Deborha; Benedetto, Chiara; Frediani, Fabio; Bussone, Gennaro

    2014-05-01

    Drugs for migraine attacks include triptans and NSAIDs; their combination could provide greater symptom relief. A total of 314 subjects with history of migraine, with or without aura, were randomized to frovatriptan 2.5 mg alone (Frova), frovatriptan 2.5 mg + dexketoprofen 25 mg (FroDex25) or frovatriptan 2.5 mg + dexketoprofen 37.5 mg (FroDex37.5) and treated at least one migraine attack. This was a multicenter, randomized, double-blind, parallel-group study. The primary end point was the proportion of pain free (PF) at two hours. Secondary end points were PF at one and four hours, pain relief (PR) at one, two, four hours, sustained PF (SPF) at 24 and 48 hours, recurrence at 48 hours, resolution of nausea, photophobia and phonophobia at two and four hours, the use of rescue medication and the judgment of the treatment. The results were assessed in the full analysis set (FAS) population, which included all subjects randomized and treated for whom at least one post-dose intensity of headache was recorded. The proportions of subjects PF at two hours (primary end point) were 29% (27/93) with Frova compared with 51% (48/95 FroDex25 and 46/91 FroDex37.5) with each combination therapies ( P dexketoprofen. FroDex improved initial efficacy at two hours compared to Frova whilst maintaining efficacy at 48 hours in this study. Tolerability profiles were comparable. Intrinsic pharmacokinetic properties of the two single drugs contribute to this improved efficacy profile.

  20. Double-blind, placebo-controlled, randomized study of chlorhexidine prophylaxis for 5-fluorouracil-based chemotherapy-induced oral mucositis with nonblinded randomized comparison to oral cooling (cryotherapy) in gastrointestinal malignancies.

    Science.gov (United States)

    Sorensen, Jens Benn; Skovsgaard, Torben; Bork, Ellen; Damstrup, Lars; Ingeberg, Sten

    2008-04-01

    The purpose was to evaluate prevention of oral mucositis (OM) using chlorhexidine compared with placebo and with oral cooling (cryotherapy) during fluorouracil (5-FU)-based chemotherapy in gastrointestinal (GI) cancer. Patients with previously untreated GI cancer receiving bolus 5-FU/leucovorin chemotherapy were randomized to chlorhexidine mouthrinse 3 times a day for 3 weeks (Arm A), double-blind placebo (normal saline) with the same dose and frequency (Arm B), or cryotherapy with crushed ice 45 minutes during chemotherapy (Arm C). Patients self-reported on severity (CTC-grading) and duration of OM. Among 225 patients randomized, 206 answered the questionnaire (70, 64, and 63 patients in Arms A, B, and C, respectively) and were well balanced with respect to diagnoses, stage, age, sex, smoking habits, and performance status. Mucositis grade 3-4 occurred more frequently in Arm B (33%) than in A (13%, Pcryotherapy. The latter is easy and inexpensive but has limited use, as it is drug- and schedule-dependent. The current study is the first double-blind randomized evaluation of prophylactic chlorhexidine in a large adult patient population with solid tumors receiving highly OM-inducing chemotherapy. A role for chlorhexidine in the prevention of OM is suggested, which should be evaluated further.

  1. Comparison of tamsulosin and silodosin in the management of acute urinary retention secondary to benign prostatic hyperplasia in patients planned for trial without catheter. A prospective randomized study.

    Science.gov (United States)

    Patil, Siddangouda B; Ranka, Kshitiz; Kundargi, Vinay S; Guru, Nilesh

    2017-01-01

    We present a prospective randomized study to compare the efficacy of tamsulosin and silodosin in patients suffering from acute urinary retention caused by benign prostatic hyperplasia, planned for trial without catheter. Patients with acute urinary retention secondary to benign prostatic hyperplasia (total 160) were catheterized and randomized into two groups: Group A: tamsulosin 0.4 mg (80 patients) and Group B: silodosin 8 mg (80 patients). After three days, the catheter was removed, and patients were put on trial without catheter. Patients with a successful trial without catheter were followed up after two weeks and one month, taking into account the international prostate symptom score (IPSS), post void residual volume (PVR), and peak flow rate (PFR). Statistical analysis of the data was performed. Both group A (tamsulosin) and group B (silodosin) had similar results of trial without catheter (group A: 67.50%, group: B 60%). In follow up, three patients in group A and four patients in group B had retention of urine, requiring recatheterization. These patients were withdrawn from the study. No significant differences were present between group A and group B patients in regard with IPSS, PVR and PFR measured at the time of successful trial without catheter and during follow up at two weeks and one month. Efficacy for trial without catheter of tamsulosin was slightly higher than silodosin, but comparable. No statistical difference between tamsulosin & silodosin treated groups were found in regard with IPSS, PVR and PFR.

  2. Comparison of address-based sampling and random-digit dialing methods for recruiting young men as controls in a case-control study of testicular cancer susceptibility.

    Science.gov (United States)

    Clagett, Bartholt; Nathanson, Katherine L; Ciosek, Stephanie L; McDermoth, Monique; Vaughn, David J; Mitra, Nandita; Weiss, Andrew; Martonik, Rachel; Kanetsky, Peter A

    2013-12-01

    Random-digit dialing (RDD) using landline telephone numbers is the historical gold standard for control recruitment in population-based epidemiologic research. However, increasing cell-phone usage and diminishing response rates suggest that the effectiveness of RDD in recruiting a random sample of the general population, particularly for younger target populations, is decreasing. In this study, we compared landline RDD with alternative methods of control recruitment, including RDD using cell-phone numbers and address-based sampling (ABS), to recruit primarily white men aged 18-55 years into a study of testicular cancer susceptibility conducted in the Philadelphia, Pennsylvania, metropolitan area between 2009 and 2012. With few exceptions, eligible and enrolled controls recruited by means of RDD and ABS were similar with regard to characteristics for which data were collected on the screening survey. While we find ABS to be a comparably effective method of recruiting young males compared with landline RDD, we acknowledge the potential impact that selection bias may have had on our results because of poor overall response rates, which ranged from 11.4% for landline RDD to 1.7% for ABS.

  3. A RANDOMIZED TRIAL TO STUDY THE COMPARISON OF TRIGGER POINT DRY NEEDLING VERSUS KINESIO TAPING TECHNIQUE IN MYOFASCIAL PAIN SYNDROME DURING A 3-MONTH FOLLOW UP

    Directory of Open Access Journals (Sweden)

    Emrullah Hayta

    2016-10-01

    Full Text Available Background: Managemen of myofascial pain syndrome (MPS is a current research subject since there is a small number of randomized studies comparing different management techniques. Multiple studies attempted to assess various treatment options including trigger point dry needling and kinesiotaping. We compared the effects of trigger point dry needling and kinesiotaping in the management of myofascial pain syndome during a 3-month follow-up period. Methods: In this prospective randomized studyin MPS patients with upper trapezius muscle trigger points, the effects of dry needling (n=28 and kinesiotaping (n=27 was compared with regard to the visual analog scale (VAS, neck disability index (NDI, and Nottingham health profile (NHP scores measured at the weeks 0, 4, and 12. Results: Both dry needling and kinesiotaping comparably reduced VAS scores measured at the weeks 4 and 12 and their efficacies were more remarkable at the week 12 (p<0.05. These interventions significantly reduced the NDI and NHP score and their effects were also more remarkable at the week 12; however, dry needling was found more effective (p<0.05. Conclusion: Overall, in current clinical settings, during the management of MPS, pain can be reduced comparably by both dry needling and kinesiotaping; however, restriction in the range of motionin neck region and quality of life are more remarkably reduced by dry needling. Both dry needling and kinesiotaping can provide an increasing effectiveness up to 12 weeks.

  4. A randomized, prospective, comparison study of polyethylene glycol 3350 without electrolytes and milk of magnesia for children with constipation and fecal incontinence.

    Science.gov (United States)

    Loening-Baucke, Vera; Pashankar, Dinesh S

    2006-08-01

    Our aim was to compare 2 laxatives, namely, polyethylene glycol 3350 without electrolytes and milk of magnesia, evaluating the efficacy, safety, acceptance, and 1-year outcomes. Seventy-nine children with chronic constipation and fecal incontinence were assigned randomly to receive polyethylene glycol or milk of magnesia and were treated for 12 months in tertiary care pediatric clinics. Children were counted as improved or recovered depending on resolution of constipation, fecal incontinence, and abdominal pain after 1, 3, 6, and 12 months. An intent-to-treat analysis was used. Safety was assessed with evaluation of clinical adverse effects and blood tests. Thirty-nine children were assigned randomly to receive polyethylene glycol and 40 to receive milk of magnesia. At each follow-up visit, significant improvement was seen in both groups, with significant increases in the frequency of bowel movements, decreases in the frequency of incontinence episodes, and resolution of abdominal pain. Compliance rates were 95% for polyethylene glycol and 65% for milk of magnesia. After 12 months, 62% of polyethylene glycol-treated children and 43% of milk of magnesia-treated children exhibited improvement, and 33% of polyethylene glycol-treated children and 23% of milk of magnesia-treated children had recovered. Polyethylene glycol and milk of magnesia did not cause clinically significant side effects or blood abnormalities, except that 1 child was allergic to polyethylene glycol. In this randomized study, polyethylene glycol and milk of magnesia were equally effective in the long-term treatment of children with constipation and fecal incontinence. Polyethylene glycol was safe for the long-term treatment of these children and was better accepted by the children than milk of magnesia.

  5. Comparison of the effects of magnesium and ketamine on postoperative pain and morphine consumption. A double-blind randomized controlled clinical study.

    Science.gov (United States)

    Arıkan, Müge; Aslan, Bilge; Arıkan, Osman; Horasanlı, Eyüp; But, Abdulkadir

    2016-01-01

    To compare the effects of magnesium sulfate and ketamine on postoperative pain and total morphine consumption in a placebo-controlled design. One hundred and twenty women scheduled for total abdominal hysterectomy were included in this prospective, randomized, double-blind study. Postoperatively, when the Numeric Pain Rating Scale (NPRS) was four or more, IV-PCA morphine was applied to all patients. The patients were randomized into three groups: Group K ketamine, Group M magnesium, and Group C saline received as infusion. Total morphine consumption for 48h, pain scores, adverse effects, and patients' satisfaction were evaluated. Total morphine consumption was significantly lower in Group K (32.6±9.2 mg) than in Group M (58.9±6.5 mg) and in Group C (65.7±8.2 mg). The satisfaction level of patients in Group K was higher than the other two groups (petamine to IV-PCA morphine reduces the total consumption of morphine without psychotic effects; however, magnesium did not influence morphine consumption.

  6. Comparison between IV immune globulin (IVIG) and anti-D globulin for treatment of immune thrombocytopenia: a randomized open-label study.

    Science.gov (United States)

    Eghbali, Aziz; Azadmanesh, Peyman; Bagheri, Bahador; Taherahmadi, Hasan; Sadeghi Sedeh, Bahman

    2016-08-01

    To compare the effect of IV immune globulin (IVIG) and anti-D globulin (anti-D) for treatment of immune thrombocytopenia (ITP) in children. A randomized, open-label, single-center clinical trial was carried out in Amir-Kabir Hospital (Arak, Iran). The study was performed on 60 children with acute and chronic ITP, aged from 1 to 15 years. Patients were randomly assigned (1:1) to 50 μg/kg anti-D or 1 g/kg IVIG. Platelet counting was performed at baseline and at 3, 7, and 14 days after treatment termination. Safety assessment was performed in all patients. Anti-D caused a quicker response on the 3rd day of treatment (P anti-D had lower rate of side effects including fever (P anti-D was associated with rapid rise of platelets compared to IVIG. In addition, anti-D treatment had acceptable safety profile. © 2016 Société Française de Pharmacologie et de Thérapeutique.

  7. Comparison of error-based and errorless learning for people with severe traumatic brain injury: study protocol for a randomized control trial.

    Science.gov (United States)

    Ownsworth, Tamara; Fleming, Jennifer; Tate, Robyn; Shum, David H K; Griffin, Janelle; Schmidt, Julia; Lane-Brown, Amanda; Kendall, Melissa; Chevignard, Mathilde

    2013-11-05

    Poor skills generalization poses a major barrier to successful outcomes of rehabilitation after traumatic brain injury (TBI). Error-based learning (EBL) is a relatively new intervention approach that aims to promote skills generalization by teaching people internal self-regulation skills, or how to anticipate, monitor and correct their own errors. This paper describes the protocol of a study that aims to compare the efficacy of EBL and errorless learning (ELL) for improving error self-regulation, behavioral competency, awareness of deficits and long-term outcomes after TBI. This randomized, controlled trial (RCT) has two arms (EBL and ELL); each arm entails 8 × 2 h training sessions conducted within the participants' homes. The first four sessions involve a meal preparation activity, and the final four sessions incorporate a multitasking errand activity. Based on a sample size estimate, 135 participants with severe TBI will be randomized into either the EBL or ELL condition. The primary outcome measure assesses error self-regulation skills on a task related to but distinct from training. Secondary outcomes include measures of self-monitoring and self-regulation, behavioral competency, awareness of deficits, role participation and supportive care needs. Assessments will be conducted at pre-intervention, post-intervention, and at 6-months post-intervention. This study seeks to determine the efficacy and long-term impact of EBL for training internal self-regulation strategies following severe TBI. In doing so, the study will advance theoretical understanding of the role of errors in task learning and skills generalization. EBL has the potential to reduce the length and costs of rehabilitation and lifestyle support because the techniques could enhance generalization success and lifelong application of strategies after TBI. ACTRN12613000585729.

  8. Comparison of population-averaged and cluster-specific models for the analysis of cluster randomized trials with missing binary outcomes: a simulation study

    Directory of Open Access Journals (Sweden)

    Ma Jinhui

    2013-01-01

    Full Text Available Abstracts Background The objective of this simulation study is to compare the accuracy and efficiency of population-averaged (i.e. generalized estimating equations (GEE and cluster-specific (i.e. random-effects logistic regression (RELR models for analyzing data from cluster randomized trials (CRTs with missing binary responses. Methods In this simulation study, clustered responses were generated from a beta-binomial distribution. The number of clusters per trial arm, the number of subjects per cluster, intra-cluster correlation coefficient, and the percentage of missing data were allowed to vary. Under the assumption of covariate dependent missingness, missing outcomes were handled by complete case analysis, standard multiple imputation (MI and within-cluster MI strategies. Data were analyzed using GEE and RELR. Performance of the methods was assessed using standardized bias, empirical standard error, root mean squared error (RMSE, and coverage probability. Results GEE performs well on all four measures — provided the downward bias of the standard error (when the number of clusters per arm is small is adjusted appropriately — under the following scenarios: complete case analysis for CRTs with a small amount of missing data; standard MI for CRTs with variance inflation factor (VIF 50. RELR performs well only when a small amount of data was missing, and complete case analysis was applied. Conclusion GEE performs well as long as appropriate missing data strategies are adopted based on the design of CRTs and the percentage of missing data. In contrast, RELR does not perform well when either standard or within-cluster MI strategy is applied prior to the analysis.

  9. A randomized comparison study regarding the impact of short-duration, high-intensity exercise and traditional exercise on anthropometric and body composition measurement changes in post-menopausal women--A pilot study.

    Science.gov (United States)

    Grossman, Joan A Cebrick; Payne, Ellen K

    2016-03-01

    The mode and duration of exercise necessary to change body composition and reduce weight remains debatable. Menopause results in hormonal changes that preclude weight loss. This randomized pilot study compared the effects of short-duration, high-intensity interval training and traditional exercise on anthropometric and body composition measurement changes in post-menopausal women. To compare the effects of short-duration, high-intensity interval training and traditional methods of exercise (walking) on anthropometric, body composition and body weight change over a 12-week period. Subjects (N = 18) were post-menopausal, sedentary female volunteers, randomly assigned into one of two exercise groups. Both groups exercised five out of seven days for 12 weeks. The resistance group (n = 8) (54.3 ± 7.3 years; BMI = 28.0 ± 2.1 kg/m(2); mean ± SD) exercised for 15.0 ± 3.5 min, which consisted of five different exercise routines including upper and lower extremity, a cardio segment, yoga and abdominal exercises. The walkers (n = 10) (56.6 ± 5.2 years; BMI = 29.2 ± 2.6 kg/m(2); mean ± SD) exercised for 40.0 ± 5.0 min at 65% of their age-predicted maximum heart rate. Relative (%) body fat was measured via DEXA scan, along with five anthropometric measurements, all of which were taken prior to and after 12 weeks. Independent sample t-tests were probed for differences, p ≤ 0.05. No statistically significant changes were determined between the groups for pre-and post-measurements. The outcomes of this study provide a foundation for future comparisons of short-duration high-intensity interval training exercise and traditional exercise, or walking, on anthropometric and body composition measurement changes in sedentary, overweight, post-menopausal females over a 12-week period. © The Author(s) 2016.

  10. A comparison of low-dose risperidone to paroxetine in the treatment of panic attacks: a randomized, single-blind study

    Directory of Open Access Journals (Sweden)

    Galynker Igor I

    2009-05-01

    Full Text Available Abstract Background Because a large proportion of patients with panic attacks receiving approved pharmacotherapy do not respond or respond poorly to medication, it is important to identify additional therapeutic strategies for the management of panic symptoms. This article describes a randomized, rater-blind study comparing low-dose risperidone to standard-of-care paroxetine for the treatment of panic attacks. Methods Fifty six subjects with a history of panic attacks were randomized to receive either risperidone or paroxetine. The subjects were then followed for eight weeks. Outcome measures included the Panic Disorder Severity Scale (PDSS, the Hamilton Anxiety Scale (Ham-A, the Hamilton Depression Rating Scale (Ham-D, the Sheehan Panic Anxiety Scale-Patient (SPAS-P, and the Clinical Global Impression scale (CGI. Results All subjects demonstrated a reduction in both the frequency and severity of panic attacks regardless of treatment received. Statistically significant improvements in rating scale scores for both groups were identified for the PDSS, the Ham-A, the Ham-D, and the CGI. There was no difference between treatment groups in the improvement in scores on the measures PDSS, Ham-A, Ham-D, and CGI. Post hoc tests suggest that subjects receiving risperidone may have a quicker clinical response than subjects receiving paroxetine. Conclusion We can identify no difference in the efficacy of paroxetine and low-dose risperidone in the treatment of panic attacks. Low-dose risperidone appears to be tolerated equally well as paroxetine. Low-dose risperidone may be an effective treatment for anxiety disorders in which panic attacks are a significant component. Trial Registration ClinicalTrials.gov Identifier: NCT100457106

  11. Comparison of Continuous Femoral Nerve Block with and Without Combined Sciatic Nerve Block after Total Hip Arthroplasty: A Prospective Randomized Study.

    Science.gov (United States)

    Nishio, Shoji; Fukunishi, Shigeo; Fukui, Tomokazu; Fujihara, Yuki; Okahisa, Shohei; Takeda, Yu; Yoshiya, Shinichi

    2017-06-23

    In association with the growing interests in pain management, several modalities to control postoperative pain have been proposed and examined for the efficacy in the recent studies. Various modes of peripheral nerve block have been proposed and the effectiveness and safety have been examined for each of those techniques. We have described our clinical experiences, showing that continuous femoral nerve block could provide a satisfactory analgesic effect after total hip arthroplasty (THA) procedure. In this study, we compared the effectiveness and safety of continuous femoral nerve block with and without sciatic nerve blockade on pain control after THA. Forty patients scheduled for THA were included in the study and randomly divided into 2 groups. Postoperative analgesic measure was continuous femoral nerve block alone, while the identical regimen of continuous femoral nerve block was combined with sciatic nerve block. The amount of postoperative pain was evaluated in the immediate postoperative period, 6 hours, and 12 hours after surgery. Moreover, postoperative complications as well as requirement of supplemental analgesics during the initial 12 hours after surgery were reviewed in the patient record. The obtained study results showed that the supplemental sciatic nerve blockade provided no significant effect on arrival at the postoperative recovery room, while the NRS pain score was significantly reduced by the combined application of sciatic nerve blockade at 6 and 12 hours after surgery. In the investigation of postoperative analgesiarelated complications, no major complication was encountered without significant difference in complication rate between the groups.

  12. a randomized, placebo- controlled study

    OpenAIRE

    Hall, Franziska van

    2012-01-01

    Introduction: Repetitive transcranial magnetic stimulation (rTMS) is a well-tolerated non-invasive method, which has also been proved to have mild antidepressant effects and is used as “add-on“-therapy in treating pharmaco-resistant major depression. Objective: The efficacy of an escitalopram plus rTMS-combination-treatment was evaluated and compared to escitalopram plus sham rTMS. Methods: We designed a four week-, randomized, rater-blinded, and controlled add-on study with two trea...

  13. Comparison of three problem-based learning conditions (real patients, digital and paper) with lecture-based learning in a dermatology course: a prospective randomized study from China.

    Science.gov (United States)

    Li, Jie; Li, Qing Ling; Li, Ji; Chen, Ming Liang; Xie, Hong Fu; Li, Ya Ping; Chen, Xiang

    2013-01-01

    The precise effect and the quality of different cases used in dermatology problem-based learning (PBL) curricula are yet unclear. To prospectively compare the impact of real patients, digital, paper PBL (PPBL) and traditional lecture-based learning (LBL) on academic results and student perceptions. A total of 120 students were randomly allocated into either real-patients PBL (RPBL) group studied via real-patient cases, digital PBL (DPBL) group studied via digital-form cases, PPBL group studied via paper-form cases, or conventional group who received didactic lectures. Academic results were assessed through review of written examination, objective structured clinical examination and student performance scores. A five-point Likert scale questionnaire was used to evaluate student perceptions. Compared to those receiving lectures only, all PBL participants had better results for written examination, clinical examination and overall performance. Students in RPBL group exhibited better overall performance than those in the other two PBL groups. Real-patient cases were more effective in helping develop students' self-directed learning skills, improving their confidence in future patient encounters and encouraging them to learn more about the discussed condition, compared to digital and paper cases. Both real patient and digital triggers are helpful in improving students' clinical problem-handling skills. However, real patients provide greater benefits to students.

  14. Comparison of two theory-based, fully automated telephone interventions designed to maintain dietary change in healthy adults: study protocol of a three-arm randomized controlled trial.

    Science.gov (United States)

    Wright, Julie A; Quintiliani, Lisa M; Turner-McGrievy, Gabrielle M; Migneault, Jeffrey P; Heeren, Timothy; Friedman, Robert H

    2014-11-10

    Health behavior change interventions have focused on obtaining short-term intervention effects; few studies have evaluated mid-term and long-term outcomes, and even fewer have evaluated interventions that are designed to maintain and enhance initial intervention effects. Moreover, behavior theory has not been developed for maintenance or applied to maintenance intervention design to the degree that it has for behavior change initiation. The objective of this paper is to describe a study that compared two theory-based interventions (social cognitive theory [SCT] vs goal systems theory [GST]) designed to maintain previously achieved improvements in fruit and vegetable (F&V) consumption. The interventions used tailored, interactive conversations delivered by a fully automated telephony system (Telephone-Linked Care [TLC]) over a 6-month period. TLC maintenance intervention based on SCT used a skills-based approach to build self-efficacy. It assessed confidence in and barriers to eating F&V, provided feedback on how to overcome barriers, plan ahead, and set goals. The TLC maintenance intervention based on GST used a cognitive-based approach. Conversations trained participants in goal management to help them integrate their newly acquired dietary behavior into their hierarchical system of goals. Content included goal facilitation, conflict, shielding, and redundancy, and reflection on personal goals and priorities. To evaluate and compare the two approaches, a sample of adults whose F&V consumption was below public health goal levels were recruited from a large urban area to participate in a fully automated telephony intervention (TLC-EAT) for 3-6 months. Participants who increase their daily intake of F&V by ≥1 serving/day will be eligible for the three-arm randomized controlled trial. A sample of 405 participants will be randomized to one of three arms: (1) an assessment-only control, (2) TLC-SCT, and (3) TLC-GST. The maintenance interventions are 6 months. All 405

  15. A systematic literature review on the efficacy–effectiveness gap: comparison of randomized controlled trials and observational studies of glucose-lowering drugs

    Directory of Open Access Journals (Sweden)

    Ankarfeldt MZ

    2017-01-01

    Full Text Available Mikkel Z Ankarfeldt,1,2 Erpur Adalsteinsson,1 Rolf HH Groenwold,2,3 M Sanni Ali,2,3,4 Olaf H Klungel,2,3 On behalf of GetReal Work Package 2 1Novo Nordisk A/S, 2Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, 3Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, University of Utrecht, Utrecht, the Netherlands; 4Nuffield Department of Orthopaedics, Rheumatology, Musculoskeletal Sciences, University of Oxford, Oxford, UK Aim: To identify a potential efficacy–effectiveness gap and possible explanations (drivers of effectiveness for differences between results of randomized controlled trials (RCTs and observational studies investigating glucose-lowering drugs. Methods: A systematic literature review was conducted in English language articles published between 1 January, 2000 and 31 January, 2015 describing either RCTs or observational studies comparing glucagon-like peptide-1 analogs (GLP-1 with insulin or comparing dipeptidyl peptidase-4 inhibitors (DPP-4i with sulfonylurea, all with change in glycated hemoglobin (HbA1c as outcome. Medline, Embase, Current Content, and Biosis were searched. Information on effect estimates, baseline characteristics of the study population, publication year, study duration, and number of patients, and for observational studies, characteristics related to confounding adjustment and selection- and information bias were extracted. Results: From 312 hits, 11 RCTs and 7 observational studies comparing GLP-1 with insulin, and from 474 hits, 16 RCTs and 4 observational studies comparing DPP-4i with sulfonylurea were finally included. No differences were observed in baseline characteristics of the study populations (age, sex, body mass index, time since diagnosis of type 2 diabetes mellitus, and HbA1c or effect sizes across study designs. Mean effect sizes ranged from −0.43 to 0.91 and from −0.80 to 1.13 in RCTs and

  16. Prospective randomized comparison of rotational angiography with three-dimensional reconstruction and computed tomography merged with electro-anatomical mapping: a two center atrial fibrillation ablation study.

    Science.gov (United States)

    Anand, Rishi; Gorev, Maxim V; Poghosyan, Hermine; Pothier, Lindsay; Matkins, John; Kotler, Gregory; Moroz, Sarah; Armstrong, James; Nemtsov, Sergei V; Orlov, Michael V

    2016-08-01

    To compare the efficacy and accuracy of rotational angiography with three-dimensional reconstruction (3DATG) image merged with electro-anatomical mapping (EAM) vs. CT-EAM. A prospective, randomized, parallel, two-center study conducted in 36 patients (25 men, age 65 ± 10 years) undergoing AF ablation (33 % paroxysmal, 67 % persistent) guided by 3DATG (group 1) vs. CT (group 2) image fusion with EAM. 3DATG was performed on the Philips Allura Xper FD 10 system. Procedural characteristics including time, radiation exposure, outcome, and navigation accuracy were compared between two groups. There was no significant difference between the groups in total procedure duration or time spent for various procedural steps. Minor differences in procedural characteristics were present between two centers. Segmentation and fusion time for 3DATG or CT-EAM was short and similar between both centers. Accuracy of navigation guided by either method was high and did not depend on left atrial size. Maintenance of sinus rhythm between the two groups was no different up to 24 months of follow-up. This study did not find superiority of 3DATG-EAM image merge to guide AF ablation when compared to CT-EAM fusion. Both merging techniques result in similar navigation accuracy.

  17. Comparison of antianginal efficacy of nifedipine and isosorbide dinitrate in chronic stable angina: a long-term, randomized, double-blind, crossover study

    International Nuclear Information System (INIS)

    Liang, C.S.; Coplin, B.; Wellington, K.

    1985-01-01

    Using a double-blind, crossover design, the comparative efficacy and safety of nifedipine and isosorbide dinitrate in the treatment of stable angina were studied in 34 patients. The study included a 2-week placebo washout period and two 6-week periods during which patients were randomized to either nifedipine or isosorbide dinitrate. The doses were titrated for each patient, and mean doses of the 2 drugs were comparable. A time-limited thallium treadmill test was performed at the end of each phase. Ischemic zone count rates were normalized to those of the nonischemic zone, and the change in this ratio with redistribution was calculated as reversible thallium defect. Two patients were discontinued from the study within 1 week after initiation of isosorbide dinitrate because of severe, intolerable headache. Two patients were withdrawn while receiving nifedipine: one had new congestive heart failure and the other had increasing angina. Of the remaining 30 patients who tolerated both drugs for at least 1 week, 4 patients from the isosorbide dinitrate group were either prematurely crossed over or discontinued from the study because of headache. One patient suffered headache from both drugs and was discontinued from the study. In the 30 patients, only nifedipine significantly reduced resting arterial pressure compared with baseline. Further, only nifedipine therapy resulted in significant decreases in the rate-pressure product and systolic pressure at a given workload. However, significant decreases in angina frequency, nitroglycerin consumption and exercise-induced maximum ST-segment depression and reversible thallium perfusion defect were produced by both nifedipine and isosorbide dinitrate

  18. Comparison of the urinary excretion of quercetin glycosides from red onion and aglycone from dietary supplements in healthy subjects: a randomized, single-blinded, cross-over study.

    Science.gov (United States)

    Shi, Yuanlu; Williamson, Gary

    2015-05-01

    Some intervention studies have shown that quercetin supplementation can regulate certain biomarkers, but it is not clear how the doses given relate to dietary quercetin (e.g. from onion). We conducted a two-period, two-sequence crossover study to compare the bioavailability of quercetin when administered in the form of a fresh red onion meal (naturally glycosylated quercetin) or dietary supplement (aglycone quercetin) under fasting conditions. Six healthy, non-smoking, adult males with BMI 22.7 ± 4.0 kg m(-2) and age 35.3 ± 12.3 y were grouped to take the two study meals in random order. In each of the 2 study periods, one serving of onion soup (made from 100 g fresh red onion, providing 156.3 ± 3.4 μmol (47 mg) quercetin) or a single dose of a quercetin dihydrate tablet (1800 ± 150 μmol (544 mg) of quercetin) were administered following 3 d washout. Urine samples were collected up to 24 h, and after enzyme deconjugation, quercetin was quantified by LC-MS. The 24 h urinary excretion of quercetin (1.69 ± 0.79 μmol) from red onion in soup was not significantly different to that (1.17 ± 0.44 μmol) for the quercetin supplement tablet (P = 0.065, paired t-test). This means that, in practice, 166 mg of quercetin supplement would be comparable to about 10 mg of quercetin aglycone equivalents from onion. These data allow intervention studies on quercetin giving either food or supplements to be more effectively compared.

  19. Comparison of tamsulosin plus serenoa repens with tamsulosin in the treatment of benign prostatic hyperplasia in Korean men: 1-year randomized open label study.

    Science.gov (United States)

    Ryu, Young Woo; Lim, Song Won; Kim, Jung Hoon; Ahn, Seung Hyun; Choi, Jae Duck

    2015-01-01

    In Korea, increasing attention has recently been given to the use of phytotherapeutic agents to alleviate the symptoms of BPH. Serenoa repens has been shown to have an equivalent efficacy to Finasteride or Tamsulosin in the treatment of BPH in previous studies. The present study was designed to compare the efficacy and safety of Serenoa repens plus tamsulosin with tamsulosin only over 12 months in men with LUTS secondary to BPH. One hundred forty men with symptomatic BPH (IPSS≥10) were recruited in our hospital for a 12-month, open-label, randomized trial. Patients were randomly assigned to either tamsulosin 0.2 mg/day plus Serenoa repens 320 mg/day (n=60) or tamsulosin 0.2 mg/day only (n=60). Prostate volume and PSA were measured at baseline and at end-point, whereas total IPSS, and its storage and voiding subscores, LUTS-related QoL, Qmax, and PVR were evaluated at baseline and later every 6 months. Total 103 patients were finally available: 50 in the TAM+SR group and 53 in the TAM group. At 12 months, total IPSS decreased by 5.8 with TAM+SR and 5.5 with TAM (p=0.693); the storage symptoms improved significantly more with TAM+SR (-1.7 vs. -0.8 with TAM, p=0.024). This benefit with regard to storage symptom in the TAM+SR group lasts at 12 months (-1.9 vs. -0.9, p=0.024). The changes of voiding subscore, LUTS-related QoL, Qmax, PVR, PSA, and prostate volume showed no significant differences between the TAM+SR and TAM groups. During the treatment period, 8 patients (16.9%) with TAM and 10 (20%) with TAM+SR had drug-related adverse reactions, which included ejaculatory disorders, postural hypotension, dizziness, headache, gastro-intestinal disorders, rhinitis, fatigue and asthenia. The combination treatment of Serenoa repens and tamsulosin was shown to be more effective than tamsulosin monotherapy in reducing storage symptoms in BPH patients after 6 months and up to 12 months of treatment. © 2015 S. Karger AG, Basel.

  20. Comparison of a fractional microplasma radio frequency technology and carbon dioxide fractional laser for the treatment of atrophic acne scars: a randomized split-face clinical study.

    Science.gov (United States)

    Zhang, Zhen; Fei, Ye; Chen, Xiangdong; Lu, Wenli; Chen, Jinan

    2013-04-01

    No studies have compared fractional microplasma radio frequency (RF) technology with the carbon dioxide fractional laser system (CO2 FS) in the treatment of atrophic acne scars in the same patient. To compare the efficacy and safety of fractional microplasma RF with CO2 FS in the treatment of atrophic acne scars. Thirty-three Asian patients received three sessions of a randomized split-face treatment of fractional microplasma RF or CO2 FS. Both modalities had a roughly equivalent effect. Échelle d'Évaluation Clinique Des Cicatrices d'Acné scores were significantly lower after fractional microplasma RF (from 51.1 ± 14.2 to 22.3 ± 8.6, 56.4% improvement) and CO2 FS (from 48.8 ± 15.1 to 19.9 ± 7.9, 59.2% improvement) treatments. There was no statistically significant difference between the two therapies. Twelve subjects (36.4%) experienced postinflammatory hyperpigmentation (PIH) after 30 of 99 treatment sessions (30.3%) on the CO2 FS side and no PIH was observed on the fractional microplasma RF sides. Both modalities have good effects on treating atrophic scars. PIH was not seen with the fractional microplasma RF, which might make it a better choice for patients with darker skin. © 2013 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, Inc.

  1. Comparison of surgical conditions following premedication with oral clonidine versus oral diazepam for endoscopic sinus surgery: A randomized, double-blinded study

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    Rohini V Bhat Pai

    2016-01-01

    Full Text Available Background and Aims: Endoscopic sinus surgery (ESS provides a challenge and an opportunity to the anesthesiologists to prove their mettle and give the surgeons a surgical field which can make their delicate surgery safer,more precise and faster. The aim of the study was to evaluate the surgical field and the rate of blood loss in patients premedicated with oral clonidine versus oral diazepam for endoscopic sinus surgery. Material and Methods: ASA I or II patients who were scheduled to undergo ESS were randomly allocated to group D (n = 30 or group C (n = 30. The patients′ vital parameters, propofol infusion rate, and rate of blood loss were observed and calculated. The surgeon, who was blinded, rated the visibility of the surgical field from grade 0-5. Results: In the clonidine group, the rate of blood loss, the surgical time, propofol infusion rate was found to be statistically lower as compared to the diazepam group. Also a higher number of patients in the clonidine group had a better surgical score (better surgical field than the diazepam group and vice versa. Conclusions: Premedication with clonidine as compared to diazepam, provides a better surgical field with less blood loss in patients undergoing ESS.

  2. Hepatic and vascular enhancement at dual-phase helical CT: comparison of Iobitridol 300 and Iohexol 300 in a prospective randomized study

    International Nuclear Information System (INIS)

    Legmann, P.; Vignaux, O.; Bahurel, H.; Oudjit, A.; Coste, J.

    2001-01-01

    The purpose of this study was to determine hepatic and vascular enhancement, clinical tolerance, and iconographic quality of Iobitridol (300 mg/ml) at dual-phase helical CT and to compare it with Iohexol (300 mg/ml). One hundred forty-six patients were randomly divided into two groups. Each group received 120 ml of Iohexol (group A) or Iobitridol (group B). Mean enhancement of liver, aorta and portal vein was obtained at the arterial phase and at the portal-venous phase. Overall image quality was assessed by two independent blinded investigators. Adverse reactions were recorded. There were no significant differences in demographic characteristics and distribution of patient intrinsic parameters between the two groups, except for blood pressure but without statistical correlation between the difference in blood pressure and the impact on enhancement measurements. There was no significant difference in clinical tolerance and image quality. Mean liver as well as aortic and portal vein enhancement measurements did not show any significant difference. Iobitridol compares favorably with Iohexol. Both products have similar safety, tolerance, and efficacy. Both contrast media have equivalent blood pool concentration and interstitial compartment diffusion. (orig.)

  3. Hepatic and vascular enhancement at dual-phase helical CT: comparison of Iobitridol 300 and Iohexol 300 in a prospective randomized study

    Energy Technology Data Exchange (ETDEWEB)

    Legmann, P.; Vignaux, O.; Bahurel, H.; Oudjit, A. [Dept. of Radiology, Universite Rene Descartes, Paris (France); Coste, J. [Dept. of Biostatistics and Epidemiology, Universite Rene Descartes, Paris (France)

    2001-11-01

    The purpose of this study was to determine hepatic and vascular enhancement, clinical tolerance, and iconographic quality of Iobitridol (300 mg/ml) at dual-phase helical CT and to compare it with Iohexol (300 mg/ml). One hundred forty-six patients were randomly divided into two groups. Each group received 120 ml of Iohexol (group A) or Iobitridol (group B). Mean enhancement of liver, aorta and portal vein was obtained at the arterial phase and at the portal-venous phase. Overall image quality was assessed by two independent blinded investigators. Adverse reactions were recorded. There were no significant differences in demographic characteristics and distribution of patient intrinsic parameters between the two groups, except for blood pressure but without statistical correlation between the difference in blood pressure and the impact on enhancement measurements. There was no significant difference in clinical tolerance and image quality. Mean liver as well as aortic and portal vein enhancement measurements did not show any significant difference. Iobitridol compares favorably with Iohexol. Both products have similar safety, tolerance, and efficacy. Both contrast media have equivalent blood pool concentration and interstitial compartment diffusion. (orig.)

  4. Comparison of low back mobility and stability exercises from Pilates in non-specific low back pain: A study protocol of a randomized controlled trial.

    Science.gov (United States)

    Miranda, Iã Ferreira; Souza, Catiane; Schneider, Alexandre Tavares; Chagas, Leandro Campos; Loss, Jefferson Fagundes

    2018-05-01

    There is some evidence in the literature about the effectiveness of the Pilates methods in the low back pain. Moreover, Pilates focus on exercises that empathizes the stability and/or mobility of the spine. Therefore, it is discussed in the literature whether higher levels of stability or mobility of the lumbar spine generates better results, both in performance and rehabilitation for low back pain. Compare the effects of the low back mobility and stability exercises from Pilates Method on low back pain, disability and movement functionality in individuals with non-specific chronic low back pain. 28 participants will be randomized into two exercise protocol from Pilates methods, one focusing on low back stability and other on low back mobility. Low back pain (visual analogic scale), low back disability (Oswestry) and movement functionality (7 functional movement tasks) will be evaluated before and after 10 sessions of Pilates exercise by the same trained assessor. A mixed designed ANOVA with two factors will be used. This study is the first to compare these outcomes for chronic low back pain participants with two exercises protocol focusing on low back mobility and stability and the results will evaluate what to prioritize with Pilates exercises to give better results for that population. Copyright © 2017 Elsevier Ltd. All rights reserved.

  5. Comparison of Dry Needling versus Orthopedic Manual Therapy in Patients with Myofascial Chronic Neck Pain: A Single-Blind, Randomized Pilot Study

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    Irene Campa-Moran

    2015-01-01

    Full Text Available Objective. The aim of this study was to compare the efficacy of three interventions for the treatment of myofascial chronic neck pain. Methods. Thirty-six patients were randomly assigned to one of three intervention groups: orthopedic manual therapy (OMT, dry needling and stretching (DN-S, and soft tissue techniques (STT. All groups received two treatment sessions with a 48 h time interval. Outcome measures included neck pain intensity measured using a visual analogue scale, cervical range of motion (ROM, pressure pain threshold for measuring mechanical hyperalgesia, and two self-reported questionnaires (neck disability index and pain catastrophizing scale. Results. The ANOVA revealed significant differences for the group × time interaction for neck disability, neck pain intensity, and pain catastrophizing. The DN-S and OMT groups reduced neck disability. Only the OMT group showed decreases in mechanical hyperalgesia and pain catastrophizing. The cervical ROM increased in OMT (i.e., flexion, side-bending, and rotation and DN-S (i.e., side-bending and rotation groups. Conclusions. The three interventions are all effective in reducing pain intensity. Reduction in mechanical hyperalgesia and pain catastrophizing was only observed in the OMT group. Cervical ROM improved in the DN-S and OMT groups and also neck disability being only clinically relevant for OMT group.

  6. Comparison of titanium and polyetheretherketone (PEEK) cages in the surgical treatment of multilevel cervical spondylotic myelopathy: a prospective, randomized, control study with over 7-year follow-up.

    Science.gov (United States)

    Chen, Yu; Wang, Xinwei; Lu, Xuhua; Yang, Lili; Yang, Haisong; Yuan, Wen; Chen, Deyu

    2013-07-01

    Anterior cervical discectomy and fusion (ACDF) with titanium- or polyetheretherketone (PEEK)-cage reconstruction is widely used in the treatment of cervical spondylotic myelopathy (CSM). This study was to compare outcomes of titanium and PEEK cages in the treatment of multilevel CSM. Between November 2002 and December 2004, a total of 80 patients with 3-level CSM were randomized in a 1:1 ratio to titanium group and PEEK group. The overall follow-up period of the patients ranged from 86 to 116 months (average 99.7 months). Clinical and radiological results were compared between titanium group and PEEK group. At the final follow-up, the clinical outcomes including JOA score, NDI score, and the excellent and good rates of clinical outcomes in the PEEK group were better than those in the titanium group. More loss of the Cobb angles and the intervertebral height was observed in the titanium group, resulting in the radiological parameters in the titanium group becoming inferior to the PEEK group at the final follow-up. Cage subsidence rates were 34.5 and 5.4% in the titanium and PEEK groups, respectively. Fusion was observed in all patients of two groups at the final follow-up. Two patients presented with cage dislocation without clinical symptoms in the titanium group. In surgical treatment of multilevel CSM, PEEK cage is superior to titanium cage in maintenance of intervertebral height and cervical lordosis, resulting in better clinical outcomes in the long-term follow-up.

  7. Distance learning strategies for weight management utilizing social media: A comparison of phone conference call versus social media platform. Rationale and design for a randomized study.

    Science.gov (United States)

    Willis, Erik A; Szabo-Reed, Amanda N; Ptomey, Lauren T; Steger, Felicia L; Honas, Jeffery J; Al-Hihi, Eyad M; Lee, Robert; Vansaghi, Lisa; Washburn, Richard A; Donnelly, Joseph E

    2016-03-01

    Management of obesity in the context of the primary care physician visit is of limited efficacy in part because of limited ability to engage participants in sustained behavior change between physician visits. Therefore, healthcare systems must find methods to address obesity that reach beyond the walls of clinics and hospitals and address the issues of lifestyle modification in a cost-conscious way. The dramatic increase in technology and online social networks may present healthcare providers with innovative ways to deliver weight management programs that could have an impact on health care at the population level. A randomized study will be conducted on 70 obese adults (BMI 30.0-45.0 kg/m(2)) to determine if weight loss (6 months) is equivalent between weight management interventions utilizing behavioral strategies by either a conference call or social media approach. The primary outcome, body weight, will be assessed at baseline and 6 months. Secondary outcomes including waist circumference, energy and macronutrient intake, and physical activity will be assessed on the same schedule. In addition, a cost analysis and process evaluation will be completed. Copyright © 2016 Elsevier Inc. All rights reserved.

  8. Comparison of clinical effects of beclomethasone dipropionate & budesonide in treatment of children with mild persistent asthma: A double-blind, randomized, controlled study

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    Anju Singh

    2016-01-01

    Full Text Available Background & objectives: Various inhaled corticosteroids (ICSs are available to control the symptoms of asthma. Although beclomethasone dipropionate (BDP and budesonide (BUD are one of the oldest ICSs, their wide availability and low cost make them attractive options in developing countries. Due to lack of consensus on which of the two drugs is better for controlling mild persistent asthma, we undertook this study to compare the efficacy of these two drugs by measuring the change in percentage predicted forced expiratory volume in one second (FEV 1 from baseline in children with mild persistent asthma. Methods: A double-blind, randomized, parallel group study was conducted in children 7-15 yr of age with newly diagnosed asthma. Of the 85 cases of mild persistent asthma, 42 received BUD while 43 received BDP at a dose of 400 µg/day using pressurized metered-dose inhaler with valved spacer for two months. The outcomes measured were change in FEV 1 , symptom scores and side effects. Results: There was a significant (P < 0.05 improvement in FEV 1 in BUD group (98.43 ± 4.63% than in BDP group (95.65 ± 5.66% at the end of two months of treatment. The mean symptom scores in BUD group (0.28 ± 1.22 and BDP group (0.43 ± 1.52 were comparable after two months. No side effects were seen in either group. Interpretation & conclusions: FEV 1 was significantly greater in BUD group than BDP group. Improvement in symptoms and incidence of side effects were similar. Our findings indicate that both BDP and BUD can be used effectively in the management of children with mild persistent asthma. [CTRI No: CTRI/2013/03/003495].

  9. Comparison of the Effects of pH-Dependent Peppermint Oil and Synbiotic Lactol (Bacillus coagulans + Fructooligosaccharides) on Childhood Functional Abdominal Pain: A Randomized Placebo-Controlled Study.

    Science.gov (United States)

    Asgarshirazi, Masoumeh; Shariat, Mamak; Dalili, Hosein

    2015-04-01

    Still there is no consensus on the best treatment for abdominal pain-related functional Gastrointestinal Disorders (FGIDs). The purpose of this study was to compare the effects of a synbiotic Lactol (Bacillus coagulans + fructooligosaccharide (FOS)), peppermint oil (Colpermin) and placebo (folic acid) on abdominal pain-related FGIDs except for abdominal migraine. This placebo-controlled study was conducted on 120 children aged 4 - 13 years to compare the efficacy of pH-dependent peppermint oil (Colpermin) versus synbiotic Lactol (Bacillus coagulans + fructooligosaccharids (FOS)) in decreasing duration, severity and frequency of functional abdominal pain. The patients were randomly allocated into three equal groups (n = 40 in each group) and each group received Colpermin or Lactol or placebo. Eighty-eight out of 120 enrolled patients completed a one-month protocol and analyses were performed on 88 patients' data. Analyses showed that improvement in pain duration, frequency and severity in the Colpermin group was better than the placebo group (P = 0.0001, P = 0.0001 and P = 0.001, respectively). Moreover, pain duration and frequency were decreased in the Lactol group more than the placebo (P = 0.012 and P = 0.0001, respectively), but changes in pain severity were not significant (P = 0.373). Colpermin was superior to Lactol in decreasing pain duration and severity (P = 0.040 and P = 0.013, respectively). No known side effects or intolerance were seen with Colpermin or Lactol. The pH-dependent peppermint oil capsule and Lactol tablet (Bacillus coagulans+ FOS) as synbiotics seem to be superior to placebo in decreasing the severity, duration and frequency of pain in abdominal pain-related functional GI disorders.

  10. Randomized controlled study of MONARC® vs. tension-free vaginal tape obturator (TVT-O®) in the treatment of female urinary incontinence: comparison of 3-year cure rates.

    Science.gov (United States)

    Park, Yoo Jun; Kim, Duk Yoon

    2012-04-01

    Transobturator approaches to midurethral sling surgery are one of the most commonly performed operations for female stress urinary incontinence throughout the world. However, very few results of randomized clinical trials of transobturator midurethral sling surgery (MONARC vs. TVT-O) for the treatment of female urinary incontinence have been reported. In this study, we compared the 3-year follow-up cure rates of these two procedures. From July 2006 to June 2008, 74 patients who had undergone MONARC (35 patients) or TVT-O (39 patients) were included in the study and were analyzed prospectively. The mean follow-up duration of both groups was 39.2 months. Preoperative and postoperative evaluations included physical examination, uroflowmetry and postvoid residual measurement, involuntary urine loss with physical activity, and urinary symptoms. Cure of female urinary incontinence was defined as patient report of no loss of urine upon physical activity. The patients' satisfaction after treatment was rated as very satisfied, satisfied, equivocal, and unsatisfied. Very satisfied and satisfied were considered as the satisfied rate. There were no significant differences in preoperative patient characteristics, postoperative complications, or success rate between the two groups. The cure rate of the MONARC and TVT-O groups was 85.7% and 84.6%, respectively. The patient satisfaction (very satisfied, satisfied) rate of the MONARC and TVT-O groups was 82.8% and 82.1%, respectively. The MONARC and TVT-O procedures were equally efficient for the treatment of female urinary incontinence, with maintenance of high cure rates for 3 years. Longer follow-up is needed to confirm these results.

  11. Comparison of toxin removal outcomes in online hemodiafiltration and intra-dialytic exercise in high-flux hemodialysis: A prospective randomized open-label clinical study protocol

    Directory of Open Access Journals (Sweden)

    Maheshwari Vaibhav

    2012-11-01

    Full Text Available Abstract Background Maintenance hemodialysis (HD patients universally suffer from excess toxin load. Hemodiafiltration (HDF has shown its potential in better removal of small as well as large sized toxins, but its efficacy is restricted by inter-compartmental clearance. Intra-dialytic exercise on the other hand is also found to be effective for removal of toxins; the augmented removal is apparently obtained by better perfusion of skeletal muscles and decreased inter-compartmental resistance. The aim of this trial is to compare the toxin removal outcome associated with intra-dialytic exercise in HD and with post-dilution HDF. Methods/design The main hypothesis of this study is that intra-dialytic exercise enhances toxin removal by decreasing the inter-compartmental resistance, a major impediment for toxin removal. To compare the HDF and HD with exercise, the toxin rebound for urea, creatinine, phosphate, and β2-microglobulin will be calculated after 2 hours of dialysis. Spent dialysate will also be collected to calculate the removed toxin mass. To quantify the decrease in inter-compartmental resistance, the recently developed regional blood flow model will be employed. The study will be single center, randomized, self-control, open-label prospective clinical research where 15 study subjects will undergo three dialysis protocols (a high flux HD, (b post-dilution HDF, (c high flux HD with exercise. Multiple blood samples during each study session will be collected to estimate the unknown model parameters. Discussion This will be the first study to investigate the exercise induced physiological change(s responsible for enhanced toxin removal, and compare the toxin removal outcome both for small and middle sized toxins in HD with exercise and HDF. Successful completion of this clinical research will give important insights into exercise effect on factors responsible for enhanced toxin removal. The knowledge will give confidence for implementing

  12. Comparison of Epidural Analgesia with Transversus Abdominis Plane Analgesia for Postoperative Pain Relief in Patients Undergoing Lower Abdominal Surgery: A Prospective Randomized Study.

    Science.gov (United States)

    Iyer, Sadasivan Shankar; Bavishi, Harshit; Mohan, Chadalavada Venkataram; Kaur, Navdeep

    2017-01-01

    Anesthesiologists play an important role in postoperative pain management. For analgesia after lower abdominal surgery, epidural analgesia and ultrasound-guided transversus abdominis plane (TAP) block are suitable options. The study aims to compare the analgesic efficacy of both techniques. Seventy-two patients undergoing lower abdominal surgery under spinal anesthesia were randomized to postoperatively receive lumbar epidural catheter (Group E) or ultrasound-guided TAP block (Group T) through intravenous cannulas placed bilaterally. Group E received 10 ml 0.125% bupivacaine stat and 10 ml 8 th hourly for 48 h. Group T received 20 ml 0.125% bupivacaine bilaterally stat and 20 ml bilaterally 8 th hourly for 48 h. Pain at rest and on coughing, total paracetamol and tramadol consumption were recorded. Analgesia at rest was comparable between the groups in the first 16 h. At 24 and 48 h, Group E had significantly better analgesia at rest ( P = 0.001 and 0.004 respectively). Patients in Group E had significantly higher number of patients with nil or mild pain on coughing at all times. Paracetamol consumption was comparable in both groups, but tramadol consumption was significantly higher in Group T at the end of 48 h ( P = 0.001). For lower abdominal surgeries, analgesia provided by intermittent boluses of 0.125% is comparable for first 16 h between epidural and TAP catheters. However, the quality of analgesia provided by the epidural catheter is superior to that provided by TAP catheters beyond that both at rest and on coughing with reduced opioid consumption.

  13. Comparison Between Ultrasound-Guided Supraclavicular and Interscalene Brachial Plexus Blocks in Patients Undergoing Arthroscopic Shoulder Surgery: A Prospective, Randomized, Parallel Study.

    Science.gov (United States)

    Ryu, Taeha; Kil, Byung Tae; Kim, Jong Hae

    2015-10-01

    Although supraclavicular brachial plexus block (SCBPB) was repopularized by the introduction of ultrasound, its usefulness in shoulder surgery has not been widely reported. The objective of this study was to compare motor and sensory blockades, the incidence of side effects, and intraoperative opioid analgesic requirements between SCBPB and interscalene brachial plexus block (ISBPB) in patients undergoing arthroscopic shoulder surgery. Patients were randomly assigned to 1 of 2 groups (ISBPB group: n = 47; SCBPB group: n = 46). The side effects of the brachial plexus block (Horner's syndrome, hoarseness, and subjective dyspnea), the sensory block score (graded from 0 [no cold sensation] to 100 [intact sensation] using an alcohol swab) for each of the 5 dermatomes (C5-C8 and T1), and the motor block score (graded from 0 [complete paralysis] to 6 [normal muscle force]) for muscle forces corresponding to the radial, ulnar, median, and musculocutaneous nerves were evaluated 20 min after the brachial plexus block. Fentanyl was administered in 50 μg increments when the patients complained of pain that was not relieved by the brachial plexus block. There were no conversions to general anesthesia due to a failed brachial plexus block. The sensory block scores for the C5 to C8 dermatomes were significantly lower in the ISBPB group. However, the percentage of patients who received fentanyl was comparable between the 2 groups (27.7% [ISBPB group] and 30.4% [SCBPB group], P = 0.77). SCBPB produced significantly lower motor block scores for the radial, ulnar, and median nerves than did ISBPB. A significantly higher incidence of Horner's syndrome was observed in the ISBPB group (59.6% [ISBPB group] and 19.6% [SCBPB group], P shoulder surgery under both brachial plexus blocks. However, SCBPB produces a better motor blockade and a lower incidence of Horner's syndrome than ISBPB.

  14. A randomized, double-blind comparison study of EMLA and ELA-Max for topical anesthesia in children undergoing intravenous insertion.

    Science.gov (United States)

    Koh, Jeffrey L; Harrison, Dale; Myers, Robert; Dembinski, Robert; Turner, Helen; McGraw, Terrence

    2004-12-01

    Topical anesthetics may help reduce discomfort associated with procedures involving needle-puncture, such as intravenous (i.v.) insertions, in children. EMLA cream has become a common, noninvasive therapy for topical anesthesia in children. ELA-Max is a recently introduced topical anesthetic cream marketed as being as effective in producing topical anesthesia after a 30-min application as EMLA is after a 60-min application. The purpose of this research was to compare ELA-Max at 30 min with EMLA at 60 min for providing topical anesthesia for i.v. insertions in children. Sixty children, ages 8-17 years, requiring an i.v. were randomized to receive either the 30 min application of ELA-Max (n = 30) or the 60 min application of EMLA (n = 30). Children rated any pain associated with the i.v. insertion using a 100-mm Visual Analog Scale (VAS). The anesthesiologist assessed the presence of blanching at the site and rated the difficulty of placing the i.v. There was no clinically or statistically significant difference in pain ratings (P = 0.87) between the ELA-Max (mean = 25.7) and the EMLA (mean = 26.8) groups. ELA-Max caused significantly (P = 0.04) less blanching than EMLA, however there was no difference in the anesthesiologists' rating of the difficulty of the i.v. placement between the groups (P = 0.73). Results from this study support the claim that a 30-min application of ELA-Max (with occlusion) is as effective as a 60-min application of EMLA (with occlusion) for producing topical anesthesia for i.v. insertion in children.

  15. Comparison between Steroid Injection and Stretching Exercise on the Scalene of Patients with Upper Extremity Paresthesia: Randomized Cross-Over Study.

    Science.gov (United States)

    Kim, Yong Wook; Yoon, Seo Yeon; Park, Yongbum; Chang, Won Hyuk; Lee, Sang Chul

    2016-03-01

    To compare the therapeutic effects on upper extremity paresthesia of intra-muscular steroid injections into the scalene muscle with those of stretching exercise only. Twenty patients with upper extremity paresthesia who met the criteria were recruited to participate in this single-blind, crossover study. Fourteen of 20 patients were female. The average age was 45.0 ± 10.5 years and duration of symptom was 12.2 ± 8.7 months. Each participant completed one injection and daily exercise program for 2 weeks. After randomization, half of all patients received ultrasound-guided injection of scalene muscles before exercise, while the other was invested for the other patients. After two weeks, there was a significant decrease of the visual analog scale score of treatment effect compared with baseline in both groups (6.90 to 2.85 after injection and 5.65 to 4.05 after stretching exercise, p50% reduction in post-treatment visual analog scale, was 18 of 20 (90.0%) after injection, compared to 5 of 20 (25.0%) after stretching exercise. There were no cases of unintended brachial plexus block after injection. Ultrasound-guided steroid injection or stretching exercise of scalene muscles led to reduced upper extremity paresthesia in patients who present with localized tenderness in the scalene muscle without electrodiagnostic test abnormalities, although injection treatment resulted in more improvements. The results suggest that symptoms relief might result from injection into the muscle alone not related to blockade of the brachial plexus.

  16. Comparison of the Laryngeal Mask Airway (CTrachTM and Direct Coupled Interface-Video Laryngoscope for Endotracheal Intubation: a Prospective, Randomized, Clinical Study

    Directory of Open Access Journals (Sweden)

    Kamil Toker

    2012-09-01

    Full Text Available Objective: Video laryngoscopy was developed to facilitate tracheal intubation of difficult airways. We aimed to compare the efficacy of CTrach™ (CT and Direct Coupled Interface-Videolaryngoscope (DCI-VL in patients with normal airways. Material and Methods: Sixty ASA I–II (American Society of Anesthesiologists adult patients admitted for elective surgery were enrolled in this prospective study. The patients were randomly assigned to two groups, where intubation was performed via CT or DCI-VL. Time to obtain a good glottic view, total intubation time, success rates and the number of patients who required maneuvers for a good glottic view were recorded.Results: The mean time to obtaining a good glottic view was significantly longer with CT than with DCI-VL (29.4±20.3 seconds vs. 12.8±1.9 seconds, respectively; p=0.01. Intubation was achieved on the first attempt in 28 patients in the CT group (93.3% and in 24 in the DCI-VL group (80% (p=0.77. The total intubation time for CT was significantly longer compared to DCI-VL (99.9±36.0 seconds vs. 39.2±21.4 seconds, respectively; p=0.01. Optimization maneuvers were required in eight and two patients in the CT and DCI-VL groups, respectively (p=0.03.Conclusion: Although the normal airway endotracheal intubation success rates were similar in both groups, the time to obtain a good glottic view and the total intubation time were significantly shorter with DCI-VL.

  17. Efficacy of a comfrey root extract ointment in comparison to a diclofenac gel in the treatment of ankle distortions: results of an observer-blind, randomized, multicenter study.

    Science.gov (United States)

    Predel, H G; Giannetti, B; Koll, R; Bulitta, M; Staiger, C

    2005-11-01

    In the treatment of minor blunt injuries several topical drugs are known to have anti-inflammatory and analgesic properties. They represent, however, two fundamentally different major pharmacological therapy approaches: the "chemical-synthetical" and the "phytotherapeutical" approach. The main objective of this trial (CODEC_2004) was to compare the efficacy and tolerability of an ointment of Comfrey extract (Extr. Rad. Symphyti) with that of a Diclofenac gel in the treatment of acute unilateral ankle sprain (distortion). In a single-blind, controlled, randomized, parallel-group, multicenter and confirmatory clinical trial outpatients with acute unilateral ankle sprains (n=164, mean age 29.0 years, 47.6% female) received either a 6 cm long ointment layer of Kytta-Salbe f (Comfrey extract) (n=82) or of Diclofenac gel containing 1.16 g of diclofenac diethylamine salt (n=82) for 7 +/- 1 days, four times a day. Primary variable was the area-under-the-curve (AUC) of the pain reaction to pressure on the injured area measured by a calibrated caliper (tonometer). Secondary variables were the circumference of the joint (swelling; figure-of-eight method), the individual spontaneous pain sensation at rest and at movement according to a Visual Analogue Scale (VAS), the judgment of impaired movements of the injured joint by the method of "neutral-zero", consumption of rescue medication (paracetamol), as well as the global efficacy evaluation and the global assessment of tolerability (both by physician and patient, 4 ranks). In this study the primary variable was also to be validated prospectively. It was confirmatorily shown that Comfrey extract is non-inferior to diclofenac. The 95% confidence interval for the AUC (Comfrey extract minus Diclofenac gel) was 19.01-103.09h*N/cm2 and was completely above the margin of non-inferiority. Moreover, the results of the primary and secondary variables indicate that Comfrey extract may be superior to Diclofenac gel.

  18. Comparison of two doses of heparin on outcome in off-pump coronary artery bypass surgery patients: A prospective randomized control study

    Directory of Open Access Journals (Sweden)

    Murali Chakravarthy

    2017-01-01

    Full Text Available Introduction: While off pump coronary artery bypass surgery is practiced with an intention to reduce the morbidity associated with cardiopulmonary bypass, the resultant ′hypercoagulability′ needs to be addressed. Complications such as cavitary thrombus possibly due to the hyper coagulability after off pump coronary artery bypass surgery have been described. Many clinicians use higher doses of heparin - up to 5 mg/kg in order to thwart this fear. Overall, there appears to be no consensus on the dose of heparin in off pump coronary artery bypass surgeries. Aim of the Study: The aim of the study was understand the differences in outcome of such as transfusion requirement, myocardial ischemia, and morbidity when two different doses were used for systemic heparinization. Methods: Elective patients scheduled for off pump coronary artery bypass surgery were included. Ongoing anti platelet medication was not an exclusion criteria, however, anti platelet medications were ceased about a week prior to surgery when possible. Thoracic epidural anesthesia was administered as an adjunct in patients who qualified for it. By computer generated randomization chart, patients were chosen to receive either 2 or 3 mg/kg of intravenous unfractioned heparin to achieve systemic heparinization with activated clotting time targeted at >240 secs. Intraoperative blood loss, postoperative blood loss, myocardial ischemic episodes, requirement of intraaortic balloon counter pulsation and transfusion requirement were analyzed. Results: Sixty two patients participated in the study. There was one conversion to cardiopulmonary bypass. The groups had comparable ACT at baseline (138.8 vs. 146.64 seconds, P = 0.12; 3 mg/kg group had significantly higher values after heparin, as expected. But after reversal with protamine, ACT and need for additional protamine was similar among the groups. Intraoperative (685.56 ± 241.42 ml vs. 675.15 ± 251.86 ml, P = 0.82 and postoperative

  19. Comparison of High-Flexion Fixed-Bearing and High-Flexion Mobile-Bearing Total Knee Arthroplasties-A Prospective Randomized Study.

    Science.gov (United States)

    Kim, Young-Hoo; Park, Jang-Won; Kim, Jun-Shik

    2018-01-01

    There is none, to our knowledge, about comparison of high-flexion fixed-bearing and high-flexion mobile-bearing total knee arthroplasties (TKAs) in the same patients. The purpose of this study was to determine whether clinical results; radiographic and computed tomographic scan results; and the survival rate of a high-flexion mobile-bearing TKA is better than that of a high-flexion fixed-bearing TKA. The present study consisted of 92 patients (184 knees) who underwent same-day bilateral TKA. Of those, 17 were men and 75 were women. The mean age at the time of index arthroplasty was 61.5 ± 8.3 years (range 52-65 years). The mean body mass index was 26.2 ± 3.3 kg/m 2 (range 23-34 kg/m 2 ). The mean follow-up was 11.2 years (range 10-12 years). The Knee Society knee scores (93 vs 92 points; P = .531) and function scores (80 vs 80 points; P = 1.000), WOMAC scores (14 vs 15 points; P = .972), and UCLA activity scores (6 vs 6 points; P = 1.000) were not different between the 2 groups at 12 years follow-up. There were no differences in any radiographic and CT scan parameters between the 2 groups. Kaplan-Meier survivorship of the TKA component was 98% (95% confidence interval, 93-100) in the high-flexion fixed-bearing TKA group and 99% (95% confidence interval, 94-100) in the high-flexion mobile-bearing TKA group 12 years after the operation. We found no benefit to mobile-bearing TKA in terms of pain, function, radiographic and CT scan results, and survivorship. Longer-term follow-up is necessary to prove the benefit of the high-flexion mobile-bearing TKA over the high-flexion fixed-bearing TKA. Copyright © 2017 Elsevier Inc. All rights reserved.

  20. Comparison of Postoperative Pain Following Laser-assisted Subepithelial Keratectomy and Transepithelial Photorefrac-tive Keratectomy:a Prospective,Random Paired Bilateral Eye Study

    Institute of Scientific and Technical Information of China (English)

    Dongmei Wang; Guangsheng Chen; Liusong Tang; Qiaoling Li

    2014-01-01

    Purpose:.To compare postoperative pain following laser-as-sisted subepithelial keratectomy (LASEK) and transepithelial photorefractive keratectomy (T-PRK, two-step surgery) and alleviate postoperative subjective pain.Methods:.Thirty patients (60 eyes) with myopia or myopic astigmatism were consecutively recruited into this prospective, randomized paired study..Patients underwent LASEK in one eye,and T-PRK in the other. The degree of pain was rated on a scale of 0-10 on postoperative days 1,2 and 3..Uncorrected visual acuity (UCVA) and subepithelial corneal haze were as-sessed at postoperative 1 and 3 months.Results:.The pain was relieved on the 4th postoperative day in all patients,.healing of corneal epithelium was observed at 4-5 days after surgery and contact lenses were removed promptly.At postoperative 1 day,.the mean subjective pain score in the LASEK group was 3.2±1.88 and 4.43±1.61 in T-PRK group (P=0.008).No significant difference was found be-tween two groups on postoperative 2 and 3 days. At postoper-ative 3 months, the percentage of UCVA ≥0.8 in the LASEK group was 100% and 96.7% in the T-PRK group. (P=0.24), 93.3% of patients in the LASEK with UCVA ≥1.0 and 90%in the T-PRK group(P=0.64). In the LASEK group, the value of corneal haze was 0.26±0.21 and 0.27±0.25 in the T-PRK group(P=0.877).Conclusion:.Good visual acuity was obtained in both groups at postoperative 3 months. Compared with those in the T-PRK group, patients undergoing had less discomfort in the LASEK group, which may be associated with corneal epithelial activ-ity. The changing curve of subjective pain in the T-PRK group was relatively flat and stable at postoperative 3 days. (Eye Science 2014; 29:155-159)

  1. Comparison of secure messaging application (WhatsApp) and standard telephone usage for consultations on Length of Stay in the ED. A prospective randomized controlled study.

    Science.gov (United States)

    Gulacti, Umut; Lok, Ugur

    2017-07-19

    Consultation, the process of an Emergency Physician seeking an opinion from other specialties, occurs frequently in the Emergency Department (ED). The aim of this study was to determine the effect of secure messaging application (WhatsApp) usage for medical consultations on Emergency Department Length of Stay (ED LOS) and consult time. We conducted a prospective, randomized controlled trial in the ED using allocation concealment over three months. Consultations requested in the ED were allocated into two groups: consultations requested via the secure messaging application and consultations requested by telephone as verbal. A total of 439 consultations requested in the ED were assessed for eligibility and 345 were included in the final analysis: 173 consultations were conducted using secure messaging application and 172 consultations were conducted using standard telephone communications. The median ED LOS was 240 minutes (IQR:230-270, 95% CI:240 to 255.2) for patients in the secure messaging application group and 277 minutes (IQR:270-287.8, 95% CI:277 to 279) for patients in the telephone group. The median total ED LOS was significantly lower among consults conducted using Secure messaging application relative to consults conducted by telephone (median dif: -30, 95%CI:-37to-25, p<0.0001). The median consult time was 158 minutes (IQR:133 to 177.25, 95% CI:150 to 169) for patients in the Secure messaging application group and 170 minutes (IQR:165 to 188.5, 95% CI:170-171) for patients in the Telephone group (median dif: -12, 95%CI:-19 to-7,p<0.0001). Consultations completed without ED arrival was 61.8% in the secure messaging group and 33.1% in the Telephone group (dif: 28.7, 95% CI:48.3 to 66, p<0.001). Use of secure messaging application for consultations in the ED reduces the total ED LOS and consultation time. Consultation with secure messaging application eliminated more than half of in-person ED consultation visits.

  2. Video-based versus Medical Personnel-led Training for the Knowledge on Condom Use, Partner Notification and Sexually Transmitted Infections in Rural Communities in Thailand: A Randomized Comparison Pilot Study

    Directory of Open Access Journals (Sweden)

    Nut Kittipongphat

    2017-09-01

    Full Text Available Objective: To compare the knowledge regarding partner notification (PN, condom use (CU and sexually transmitted infections (STIs after video-based or medical personnel-led training. Methods: From December 2016 to January 2017, we conducted an opened-label randomized study in four communities (20 participants/ community in Bangsaphannoi district, Prachuabkirikhan province. In each community, the participants were randomly allocated into Group A (medical personnel-led training or Group B (video-based training. Both trainings covered similar contents which included knowledge about STIs (5 minutes; how to safely notify their partners (10 minutes and techniques of correct condom use (10 minutes. Participants’ knowledge was assessed by five one-best questions for each topic before and after the training. Comparison of scores within group and between groups was done by using Wilcoxon rank sum test and Wilcoxon signed rank test. P <0.05 was considered statistically significant. Results: From 160 eligible participants, 148 could complete the study (74 in Group A and 74 in Group B. Between two groups, there was no difference of participants’ characteristics, including age, education, employment, sex debut, STIs and number of partners. Both training techniques significantly improved participants’ knowledge and there was no difference between them. The lowest median score and least improvement of knowledge were found in PN. Conclusion: At the community level, both video-based training and medical personnel-led training improve the knowledge on PN, CU and STIs with comparable results.

  3. Comparison of single-use and reusable metal laryngoscope blades for orotracheal intubation during rapid sequence induction of anesthesia: a multicenter cluster randomized study.

    Science.gov (United States)

    Amour, Julien; Le Manach, Yannick Le; Borel, Marie; Lenfant, François; Nicolas-Robin, Armelle; Carillion, Aude; Ripart, Jacques; Riou, Bruno; Langeron, Olivier

    2010-02-01

    Single-use metal laryngoscope blades are cheaper and carry a lower risk of infection than reusable metal blades. The authors compared single-use and reusable metal blades during rapid sequence induction of anesthesia in a multicenter cluster randomized trial. One thousand seventy-two adult patients undergoing general anesthesia under emergency conditions and requiring rapid sequence induction were randomly assigned on a weekly basis to either single-use or reusable metal blades (cluster randomization). After induction, a 60-s period was allowed to complete intubation. In the case of failed intubation, a second attempt was performed using the opposite type of blade. The primary endpoint was the rate of failed intubation, and the secondary endpoints were the incidence of complications (oxygen desaturation, lung aspiration, and/or oropharynx trauma) and the Cormack and Lehane score. Both groups were similar in their main characteristics, including the risk factors for difficult intubation. The rate of failed intubation was significantly decreased with single-use metal blades at the first attempt compared with reusable blades (2.8 vs. 5.4%, P < 0.05). In addition, the proportion of grades III and IV in Cormack and Lehane score were also significantly decreased with single-use metal blades (6 vs. 10%, P < 0.05). The global complication rate did not reach statistical significance, although the same trend was noted (6.8% vs. 11.5%, P = not significant). An investigator survey and a measure of illumination pointed that illumination might have been responsible for this result. The single-use metal blade was more efficient than a reusable metal blade in rapid sequence induction of anesthesia.

  4. Randomized comparison of renal denervation versus intensified pharmacotherapy including spironolactone in true-resistant hypertension: six-month results from the Prague-15 study.

    Science.gov (United States)

    Rosa, Ján; Widimský, Petr; Toušek, Petr; Petrák, Ondřej; Čurila, Karol; Waldauf, Petr; Bednář, František; Zelinka, Tomáš; Holaj, Robert; Štrauch, Branislav; Šomlóová, Zuzana; Táborský, Miloš; Václavík, Jan; Kociánová, Eva; Branny, Marian; Nykl, Igor; Jiravský, Otakar; Widimský, Jiří

    2015-02-01

    This prospective, randomized, open-label multicenter trial evaluated the efficacy of catheter-based renal denervation (Symplicity, Medtronic) versus intensified pharmacological treatment including spironolactone (if tolerated) in patients with true-resistant hypertension. This was confirmed by 24-hour ambulatory blood pressure monitoring after excluding secondary hypertension and confirmation of adherence to therapy by measurement of plasma antihypertensive drug levels before enrollment. One-hundred six patients were randomized to renal denervation (n=52), or intensified pharmacological treatment (n=54) with baseline systolic blood pressure of 159±17 and 155±17 mm Hg and average number of drugs 5.1 and 5.4, respectively. A significant reduction in 24-hour average systolic blood pressure after 6 months (-8.6 [95% cofidence interval: -11.8, -5.3] mm Hg; Pblood pressure (-12.4 [95% cofidence interval: -17.0, -7.8] mm Hg; Pblood pressure comparable with intensified pharmacotherapy. © 2014 American Heart Association, Inc.

  5. [Comparison of benazepril monotherapy to amlodipine plus benazepril in the treatment of patients with mild and moderate hypertension: a multicentre, randomized, double-blind, parallel-controlled study].

    Science.gov (United States)

    Fan, Chao-mei; Yan, Li-rong; Tao, Yong-kang; Wang, Li; Li, Yu-qing; Gao, Ming-ming; Wang, Yan-ni; Li, Cheng-xiang; Wang, Xiao-wan; Lu, Xiao-lei; Pang, Hui-min; Li, Yi-shi

    2011-01-01

    To evaluate the efficacy and tolerability of the fixed combination of amlodipine 5 mg/benazepril 10 mg once-daily therapy, compared with benazepril, 10 mg, monotherapy in patients with mild and moderate hypertension, and to evaluate the 24 h antihypertensive efficacy and the duration of action by ambulatory blood pressure monitoring. In a multicenter, randomized, double-blind, parallel controlled trial, 356 cases of hypertensive patients after 2 weeks wash-out, and then given 4 weeks of benazepril 10 mg monotherapy, 220 patients with mean seated diastolic blood pressure (SeDBP) remained ≥ 90 mm Hg (1 mm Hg = 0.133 kPa) were randomly divided into benazepril 10 mg/amlodipine 5 mg (BZ10/AML5) fixed-dose combination therapy group (once a day, n = 113), and benazepril monotherapy group (daily 20 mg, n = 107). In the two groups the patients with SeDBP ≥ 90 mm Hg were doubled the dosage of the initial regimen at the end of 4-week treatment for additional 4 weeks, and the patients with SeDBP benazepril/amlodipine (10 mg/5 mg) and benazepril (20 mg) alone were 83.1%/76.0% and 85.8%/79.5%, respectively. Adverse events rates were 16.8% in the combination therapy group and 35.5% in the monotherapy group (P benazepril/amlodipine was superior to benazepril monotherapy and was well tolerated in patients with essential hypertension and allowing a satisfactory BP control for 24 hours.

  6. Comparison of clonidine versus fentanyl as an adjuvant to intrathecal ropivacaine for major lower limb surgeries: A randomized double-blind prospective study

    Directory of Open Access Journals (Sweden)

    Anita R Chhabra

    2013-01-01

    Full Text Available Background: Ropivacaine is a newer local anesthetic, proven to have a better safety margin than bupivacaine and lignocaine. While maintaining this advantage and improving the intraoperative quality of anesthesia, the use of analgesic adjuvants has been proven to be valuable. Aim: To compare the efficacy of clonidine and fentanyl as adjuvants to intrathecal isobaric ropivacaine for major lower limb surgeries. Settings and Designs: Randomized double-blind control trial. Materials and Methods: Seventy patients were randomly divided in two groups. Ropivacaine-Clonidine group (RC received 60 mcg of clonidine with 15 mg of 0.5% isobaric ropivacaine, Ropivacaine Fentanyl group (RF received 25 mcg of fentanyl with 15 mg of 0.5% isobaric ropivacaine intrathecally. The onset and duration of sensory-motor block were recorded. The total analgesia time, sedation score, hemodynamic parameters, and side-effects were noted. Statistical Analysis: SPSS statistical package was used for statistical analysis. Paired and unpaired t-test, analysis of variance and chi-square test were used for statistical calculation. Result: The duration of sensory block in RC (329.42 ± 33.86, RF (226 ± 46.98, and motor block in RC (248.51 ± 55, RF (212.60 ± 43.52 out lasted the duration of surgery (125.61 + 64.46. In clonidine group, there was significant prolongation of sensory block (P < 0.001, motor block (P < 0.01 and the total analgesia time (P < 0.001. Hypotension and bradycardia occurred in 8.6% patients in clonidine group, whereas pruritus was experienced by 8.6% patients in fentanyl group. Conclusion: Ropivacaine when combined with clonidine or fentanyl provided adequate subarachnoid block for major surgeries, wherein clonidine has advantage over fentanyl as it increased the duration of subarachnoid block and prolonged the postoperative analgesia.

  7. Double-blind, placebo-controlled, randomized study of chlorhexidine prophylaxis for 5-fluorouracil-based chemotherapy-induced oral mucositis with nonblinded randomized comparison to oral cooling (cryotherapy) in gastrointestinal malignancies

    DEFF Research Database (Denmark)

    Skovsgaard, T.; Bork, E.; Damstrup, L.

    2008-01-01

    BACKGROUND: The purpose was to evaluate prevention of oral mucositis (OM) using chlorhexidine compared with placebo and with oral cooling (cryotherapy) during fluorouracil (5-FU)-based chemotherapy in gastrointestinal (GI) cancer. METHODS: Patients with previously untreated GI cancer receiving...... bolus 5-FU/leucovorin chemotherapy were randomized to chlorhexidine mouthrinse 3 times a day for 3 weeks (Arm A), double-blind placebo (normal saline) with the same dose and frequency (Arm B), or cryotherapy with crushed ice 45 minutes during chemotherapy (Arm C). Patients self-reported on severity (CTC...... (33%) than in A (13%, Pcryotherapy. The latter is easy and inexpensive but has...

  8. Energy Contents of Frequently Ordered Restaurant Meals and Comparison with Human Energy Requirements and US Department of Agriculture Database Information: A Multisite Randomized Study

    Science.gov (United States)

    Urban, Lorien E.; Weber, Judith L.; Heyman, Melvin B.; Schichtl, Rachel L.; Verstraete, Sofia; Lowery, Nina S.; Das, Sai Krupa; Schleicher, Molly M.; Rogers, Gail; Economos, Christina; Masters, William A.; Roberts, Susan B.

    2017-01-01

    Background Excess energy intake from meals consumed away from home is implicated as a major contributor to obesity, and ~50% of US restaurants are individual or small-chain (non–chain) establishments that do not provide nutrition information. Objective To measure the energy content of frequently ordered meals in non–chain restaurants in three US locations, and compare with the energy content of meals from large-chain restaurants, energy requirements, and food database information. Design A multisite random-sampling protocol was used to measure the energy contents of the most frequently ordered meals from the most popular cuisines in non–chain restaurants, together with equivalent meals from large-chain restaurants. Setting Meals were obtained from restaurants in San Francisco, CA; Boston, MA; and Little Rock, AR, between 2011 and 2014. Main outcome measures Meal energy content determined by bomb calorimetry. Statistical analysis performed Regional and cuisine differences were assessed using a mixed model with restaurant nested within region×cuisine as the random factor. Paired t tests were used to evaluate differences between non–chain and chain meals, human energy requirements, and food database values. Results Meals from non–chain restaurants contained 1,205±465 kcal/meal, amounts that were not significantly different from equivalent meals from large-chain restaurants (+5.1%; P=0.41). There was a significant effect of cuisine on non–chain meal energy, and three of the four most popular cuisines (American, Italian, and Chinese) had the highest mean energy (1,495 kcal/meal). Ninety-two percent of meals exceeded typical energy requirements for a single eating occasion. Conclusions Non–chain restaurants lacking nutrition information serve amounts of energy that are typically far in excess of human energy requirements for single eating occasions, and are equivalent to amounts served by the large-chain restaurants that have previously been criticized

  9. Energy Contents of Frequently Ordered Restaurant Meals and Comparison with Human Energy Requirements and U.S. Department of Agriculture Database Information: A Multisite Randomized Study.

    Science.gov (United States)

    Urban, Lorien E; Weber, Judith L; Heyman, Melvin B; Schichtl, Rachel L; Verstraete, Sofia; Lowery, Nina S; Das, Sai Krupa; Schleicher, Molly M; Rogers, Gail; Economos, Christina; Masters, William A; Roberts, Susan B

    2016-04-01

    Excess energy intake from meals consumed away from home is implicated as a major contributor to obesity, and ∼50% of US restaurants are individual or small-chain (non-chain) establishments that do not provide nutrition information. To measure the energy content of frequently ordered meals in non-chain restaurants in three US locations, and compare with the energy content of meals from large-chain restaurants, energy requirements, and food database information. A multisite random-sampling protocol was used to measure the energy contents of the most frequently ordered meals from the most popular cuisines in non-chain restaurants, together with equivalent meals from large-chain restaurants. Meals were obtained from restaurants in San Francisco, CA; Boston, MA; and Little Rock, AR, between 2011 and 2014. Meal energy content determined by bomb calorimetry. Regional and cuisine differences were assessed using a mixed model with restaurant nested within region×cuisine as the random factor. Paired t tests were used to evaluate differences between non-chain and chain meals, human energy requirements, and food database values. Meals from non-chain restaurants contained 1,205±465 kcal/meal, amounts that were not significantly different from equivalent meals from large-chain restaurants (+5.1%; P=0.41). There was a significant effect of cuisine on non-chain meal energy, and three of the four most popular cuisines (American, Italian, and Chinese) had the highest mean energy (1,495 kcal/meal). Ninety-two percent of meals exceeded typical energy requirements for a single eating occasion. Non-chain restaurants lacking nutrition information serve amounts of energy that are typically far in excess of human energy requirements for single eating occasions, and are equivalent to amounts served by the large-chain restaurants that have previously been criticized for providing excess energy. Restaurants in general, rather than specific categories of restaurant, expose patrons to

  10. Randomized, interventional, prospective, comparative study to ...

    African Journals Online (AJOL)

    Randomized, interventional, prospective, comparative study to evaluate the antihypertensive efficacy and tolerability of ramipril versus telmisartan in stage 1 hypertensive patients with diabetes mellitus.

  11. Comparison of intra-articular injections of Hyaluronic Acid and Corticosteroid in the treatment of Osteoarthritis of the hip in comparison with intra-articular injections of Bupivacaine. Design of a prospective, randomized, controlled study with blinding of the patients and outcome assessors

    Directory of Open Access Journals (Sweden)

    Bellemans Johan

    2010-11-01

    Full Text Available Abstract Background Although intra-articular hyaluronic acid is well established as a treatment for osteoarthritis of the knee, its use in hip osteoarthritis is not based on large randomized controlled trials. There is a need for more rigorously designed studies on hip osteoarthritis treatment as this subject is still very much under debate. Methods/Design Randomized, controlled trial with a three-armed, parallel-group design. Approximately 315 patients complying with the inclusion and exclusion criteria will be randomized into one of the following treatment groups: infiltration of the hip joint with hyaluronic acid, with a corticosteroid or with 0.125% bupivacaine. The following outcome measure instruments will be assessed at baseline, i.e. before the intra-articular injection of one of the study products, and then again at six weeks, 3 and 6 months after the initial injection: Pain (100 mm VAS, Harris Hip Score and HOOS, patient assessment of their clinical status (worse, stable or better then at the time of enrollment and intake of pain rescue medication (number per week. In addition patients will be asked if they have complications/adverse events. The six-month follow-up period for all patients will begin on the date the first injection is administered. Discussion This randomized, controlled, three-arm study will hopefully provide robust information on two of the intra-articular treatments used in hip osteoarthritis, in comparison to bupivacaine. Trial registration NCT01079455

  12. Random comparison study of the clinical response to 153Sm-EDTMP 1.0 mCi/kg and 1.5 mCi/kg

    International Nuclear Information System (INIS)

    Pan, Z.; Zhu, S.

    2001-01-01

    Sixty-seven patient with painful bone metastases were randomized to two groups. Group 1 (n=34) received 1.0 mCi/kg of 153 Sm-EDTMP and group II (n=33) received 1.5 mCi/kg. All of them met inclusion criteria and there was no significantly difference between the basic conditions of two groups. After receiving 153 Sm-EDTMP intravenously, all patients were kept in close follow-up weekly with blood counting, physician visiting and collecting patient's self-filling-in diary including pain score, Karnofsky performance scale and analgesic consumption. The follow-up duration was six weeks. The final overall condition assessed by physician were graded into no change (including worse), slight relief, significant relief and complete relief. Only significant relief and complete relief were considered as effectiveness for pain relief. Haematological toxicity grade was evaluated based on the nadir of WBC ad PLT counts. The results indicated that the higher dosage group had a higher effectiveness rate (75.76%) compared to the lower dosage group (67.65%), but without statistic significance (x 2 =0.5365, 0.25 153 Sm-EDTMP could be used for those patients with better haematological function and 1.0 mCi/kg used for those patients with poorer haematological function. (author)

  13. Comparison of efficacy of low-carbohydrate and low-fat diet education programs in non-alcoholic fatty liver disease: A randomized controlled study.

    Science.gov (United States)

    Jang, Eun Chul; Jun, Dae Won; Lee, Seung Min; Cho, Yong Kyun; Ahn, Sang Bong

    2018-02-01

    Composition of macronutrients is important in non-alcoholic fatty liver disease (NAFLD). Diet education programs that mainly emphasize reducing fat consumption have been used for NAFLD patients. We compared the efficacy of conventional low-fat diet education with low-carbohydrate diet education in Korean NAFLD patients. One hundred and six NAFLD patients were randomly allocated to low-fat diet education or low-carbohydrate education groups for 8 weeks. Liver chemistry, liver / spleen ratio, and visceral fat using abdominal tomography were measured. Intrahepatic fat accumulation decreased significantly in the low-carbohydrate group compared to low-fat group (liver/spleen 0.85 vs. 0.92, P low-carbohydrate and 16.7% for the low-fat group (P = 0.016). Not only liver enzyme, but also low density lipoprotein cholesterol and blood pressure levels significantly decreased in the low-carbohydrate group. Total energy intake was also further decreased in the low-carbohydrate group compared to the low-fat group. Although body weight changes were not different between the two groups, the carbohydrate group had a lower total abdominal fat amount. A low-carbohydrate diet program is more realistic and effective in reducing total energy intake and hepatic fat content in Korean NAFLD patients. This trial is registered with the National Research Institute of Health: KCT0000970 (https://cris.nih.go.kr/cris/index.jsp). © 2017 The Japan Society of Hepatology.

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

    Science.gov (United States)

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

    2016-01-01

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

  15. Clinical Efficacy Comparison of Saccharomyces boulardii and Yogurt Fluid in Acute Non-Bloody Diarrhea in Children: A Randomized, Controlled, Open Label Study

    Science.gov (United States)

    Eren, Makbule; Dinleyici, Ener C.; Vandenplas, Yvan

    2010-01-01

    The purpose of this trial is to evaluate the clinical efficacy and cost/effectiveness of Saccharomyces boulardii compared with yogurt fluid (YF) in acute non-bloody diarrhea in children. This randomized, prospective open-label clinical trial includes 55 children (36 boys, 19 girls; mean age 21.2 ± 28.2 months). Group A (N = 28) received lyophilized S. boulardii and group B (N = 27) received YF. The duration of diarrhea was shorter with S. boulardii but the hospital stay was reduced with YF, although these differences were not significant. However, diarrhea had resolved in significantly more children on day 3 in the S. boulardii group (48.5% versus 25.5%; P < 0.05). In outpatient cases, yogurt treatment was cheaper than S. boulardii whereas in hospitalized patients, treatment cost was similar. In conclusion, the effect of daily freshly prepared YF was comparable to S. boulardii in the treatment of acute non-bloody diarrhea in children. The duration of diarrhea was shorter in the S. boulardii group, expressed as a significantly higher number of patients with normal stools on day 3. PMID:20207879

  16. Clinical efficacy comparison of Saccharomyces boulardii and yogurt fluid in acute non-bloody diarrhea in children: a randomized, controlled, open label study.

    Science.gov (United States)

    Eren, Makbule; Dinleyici, Ener C; Vandenplas, Yvan

    2010-03-01

    The purpose of this trial is to evaluate the clinical efficacy and cost/effectiveness of Saccharomyces boulardii compared with yogurt fluid (YF) in acute non-bloody diarrhea in children. This randomized, prospective open-label clinical trial includes 55 children (36 boys, 19 girls; mean age 21.2 +/- 28.2 months). Group A (N = 28) received lyophilized S. boulardii and group B (N = 27) received YF. The duration of diarrhea was shorter with S. boulardii but the hospital stay was reduced with YF, although these differences were not significant. However, diarrhea had resolved in significantly more children on day 3 in the S. boulardii group (48.5% versus 25.5%; P boulardii whereas in hospitalized patients, treatment cost was similar. In conclusion, the effect of daily freshly prepared YF was comparable to S. boulardii in the treatment of acute non-bloody diarrhea in children. The duration of diarrhea was shorter in the S. boulardii group, expressed as a significantly higher number of patients with normal stools on day 3.

  17. Comparison of New Technology Integrated and Nonintegrated Arterial Filters Used in Cardiopulmonary Bypass Surgery: A Randomized, Prospective, and Single Blind Study

    Directory of Open Access Journals (Sweden)

    Özgür Gürsu

    2013-01-01

    Full Text Available Background. Innovative cardiopulmonary bypass (CPB settings have been developed in order to integrate the concepts of “surface-coating,” “blood-filtration,” and “miniaturization.” Objectives. To compare integrated and nonintegrated arterial line filters in terms of peri- and postoperative clinical variables, inflammatory response, and transfusion needs. Material and Methods. Thirty-six patients who underwent coronary bypass surgery were randomized into integrated (Group In and nonintegrated arterial line filter (Group NIn groups. Arterial blood samples for the assessments of complete hemogram, biochemical screening, interleukin-6, interleukin-2R, and C-reactive protein were analyzed before and after surgery. Need for postoperative dialysis, inotropic therapy and transfusion, in addition to extubation time, total amount of drainage (mL, length of intensive care unit, and hospital stay, and mortality rates was also recorded for each patient. Results. Prime volume was significantly higher and mean intraoperative hematocrit value was lower in Group NIn, but need for erythrocyte transfusion was significantly higher in Group NIn. C-reactive protein values did not differ significantly except for postoperative second day's results, which were found significantly lower in Group In than in Group NIn. Conclusion. Intraoperative hematocrit levels were higher and need for postoperative erythrocyte transfusion was decreased in Group In.

  18. Systematic versus random sampling in stereological studies.

    Science.gov (United States)

    West, Mark J

    2012-12-01

    The sampling that takes place at all levels of an experimental design must be random if the estimate is to be unbiased in a statistical sense. There are two fundamental ways by which one can make a random sample of the sections and positions to be probed on the sections. Using a card-sampling analogy, one can pick any card at all out of a deck of cards. This is referred to as independent random sampling because the sampling of any one card is made without reference to the position of the other cards. The other approach to obtaining a random sample would be to pick a card within a set number of cards and others at equal intervals within the deck. Systematic sampling along one axis of many biological structures is more efficient than random sampling, because most biological structures are not randomly organized. This article discusses the merits of systematic versus random sampling in stereological studies.

  19. Comparison of Cardiopulmonary Resuscitation Quality Between Standard Versus Telephone-Basic Life Support Training Program in Middle-Aged and Elderly Housewives: A Randomized Simulation Study.

    Science.gov (United States)

    Kim, Tae Han; Lee, Yu Jin; Lee, Eui Jung; Ro, Young Sun; Lee, KyungWon; Lee, Hyeona; Jang, Dayea Beatrice; Song, Kyoung Jun; Shin, Sang Do; Myklebust, Helge; Birkenes, Tonje Søraas

    2018-02-01

    For cardiac arrests witnessed at home, the witness is usually a middle-aged or older housewife. We compared the quality of cardiopulmonary resuscitation (CPR) performance of bystanders trained with the newly developed telephone-basic life support (T-BLS) program and those trained with standard BLS (S-BLS) training programs. Twenty-four middle-aged and older housewives without previous CPR education were enrolled and randomized into two groups of BLS training programs. The T-BLS training program included concepts and current instruction protocols for telephone-assisted CPR, whereas the S-BLS training program provided training for BLS. After each training course, the participants simulated CPR and were assisted by a dispatcher via telephone. Cardiopulmonary resuscitation quality was measured and recorded using a mannequin simulator. The primary outcome was total no-flow time (>1.5 seconds without chest compression) during simulation. Among 24 participants, two (8.3%) who experienced mechanical failure of simulation mannequin and one (4.2%) who violated simulation protocols were excluded at initial simulation, and two (8.3%) refused follow-up after 6 months. The median (interquartile range) total no-flow time during initial simulation was 79.6 (66.4-96.9) seconds for the T-BLS training group and 147.6 (122.5-184.0) seconds for the S-BLS training group (P trained with the T-BLS training program showed shorter no-flow time and fewer interruptions during bystander CPR simulation assisted by a dispatcher.

  20. Comparison of the efficacy of 4- and 8-week lansoprazole treatment for ESD-induced gastric ulcers: a randomized, prospective, controlled study.

    Science.gov (United States)

    Park, Ji Hoon; Baek, Eun Kyung; Choi, Chang Hwan; Lee, Kyung Hun; Kim, Beom Jin; Kim, Jeong Wook; Kim, Jae Gyu; Chang, Sae Kyung

    2014-01-01

    Although endoscopic submucosal dissection (ESD) is widely used to treat gastric neoplasms, there is no consensus for the optimal treatment for ESD-induced ulcers. We compared efficacy between 4 and 8 weeks of lansoprazole treatment for iatrogenic gastric ulcers that developed after ESD. Eighty-four patients who were diagnosed with gastric adenoma or early gastric cancer were enrolled and randomly assigned to treatment with lansoprazole (30 mg/day) for 4 or 8 weeks. Eight weeks after ESD, we conducted follow-up endoscopy to compare ulcer stage and ulcer reduction ratio (dividing the ulcer dimension at 8 weeks by the initial ulcer dimension) between the two groups. From the 84 patients, 69 patients were included in the final analysis, with 34 in the 4-week group and 35 in the 8-week group. Eight weeks after ESD, there were no significant difference observed between the two groups in terms of the ulcer stage (68 % in the scar stage in the 4-week group vs. 69 % in the 8-week group, P = 0.93) or the ulcer reduction ratio (0.0081 ± 0.015 in the 4-week group vs. 0.0037 ± 0.008 in the 8-week group, P = 0.15). Also, in the subgroup analysis among the patients with large ulcers (>30 mm), those parameters were not different. For ESD-induced gastric ulcers, treatment with lansoprazole for 4 weeks was as effective as treatment for 8 weeks. Considering cost-effectiveness, proton pump inhibitor therapy for 4 weeks may be sufficient for ESD-induced gastric ulcers.

  1. Comparison of the effects of linagliptin and voglibose on endothelial function in patients with type 2 diabetes and coronary artery disease: a prospective, randomized, pilot study (EFFORT).

    Science.gov (United States)

    Koyama, Taku; Tanaka, Atsushi; Yoshida, Hisako; Oyama, Jun-Ichi; Toyoda, Shigeru; Sakuma, Masashi; Inoue, Teruo; Otsuka, Yoritaka; Node, Koichi

    2018-02-09

    Endothelial dysfunction contributes to poor cardiovascular prognosis in patients with type 2 diabetes mellitus (T2DM) and coronary artery disease (CAD). The effect of dipeptidyl peptidase-4 inhibitors on endothelial function remains controversial. We sought to compare the effects of linagliptin and voglibose on endothelial function, as assessed by reactive hyperemia-peripheral arterial tonometry (RH-PAT). Sixteen patients with newly diagnosed T2DM and CAD were randomized 1:1 to linagliptin (5 mg, once-daily) or voglibose (0.9 mg, thrice-daily). The RH-PAT and laboratory parameters, including 75 g oral glucose tolerance test, were measured at baseline and 3 months. Linagliptin increased serum levels of active glucagon-like peptide-1 and high-molecular-weight adiponectin. Age-, sex-, and baseline-adjusted changes in logarithmic RH-PAT index (LnRHI) after 3 months were significant between groups (linagliptin, 0.135 ± 0.097; voglibose, - 0.124 ± 0.091; P = 0.047). In the linagliptin group, change in LnRHI was positively correlated with change in high-density lipoprotein cholesterol and negatively correlated with changes in both urine albumin-to-creatinine ratio and high-sensitivity C-reactive protein. Furthermore, linagliptin treatment for 3 months reduced serum levels of both glucose and insulin at 2 h, relative to voglibose, in the age-, sex-, and baseline-adjusted model. Linagliptin improved endothelial function relative to voglibose, accompanied by amelioration of glycemic, renal, and cardiometabolic parameters, in patients with newly diagnosed T2DM and CAD.Trial registration Unique Trial Number, UMIN 000029169 ( https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012442 ).

  2. A Comparison of Macintosh and Airtraq Laryngoscopes for Endotracheal Intubation in Adult Patients With Cervical Spine Immobilization Using Manual In Line Axial Stabilization: A Prospective Randomized Study.

    Science.gov (United States)

    Vijayakumar, Vinodhadevi; Rao, Shwethapriya; Shetty, Nanda

    2016-10-01

    During cervical spine immobilization using Manual In Line Axial Stabilization (MILS), it is difficult to visualize the larynx by aligning the oropharyngeolaryngeal axes using Macintosh laryngoscope. Theoretically, Airtraq an anatomically shaped blade with endotracheal tube guide channel offers advantage over Macintosh. We hypothesized that intubation would be easier and faster with Airtraq compared with Macintosh laryngoscope. Ninety anesthetized adult patients with normal airways were intubated by experienced anesthesiologists after cervical immobilization with MILS either with Macintosh or Airtraq. Primary outcomes compared were successful intubation, and degree of difficulty of intubation as assessed by Intubation Difficulty Scale (IDS) score. Secondary outcomes compared were duration of laryngoscopy and intubation, degree of difficulty of intubation as assessed by Numerical Rating Scale score, soft tissue, and dental trauma. All 90 patients were successfully intubated in the first attempt. Intubation as assessed by IDS score was easier in Airtraq (84.44%) in contrast to slight difficulty in the Macintosh (77.78%) group; Numerical Rating Scale score was easy in both the groups (Airtraq-91.12%; Macintosh-93.34%). The median (interquartile range [IQR]) time for laryngoscopy, (12 s [IQR, 8 to 17.5) vs. 8 s [IQR, 6 to 12]); total duration for intubation (25 s [IQR, 20-33] vs. 22 s [IQR, 18-27.5]) were prolonged in Airtraq group in comparison to Macintosh group. In anesthetized adult patients with MILS compared with Macintosh, Airtraq provides equal success rate of intubation, statistically significant (although clinically insignificant) longer duration for laryngoscopy and intubation. Intubation with Airtraq was significantly easier than Macintosh as assessed by the IDS score.

  3. Comparison of flax (Linum usitatissimum) and Salba-chia (Salvia hispanica L.) seeds on postprandial glycemia and satiety in healthy individuals: a randomized, controlled, crossover study.

    Science.gov (United States)

    Vuksan, V; Choleva, L; Jovanovski, E; Jenkins, A L; Au-Yeung, F; Dias, A G; Ho, H V T; Zurbau, A; Duvnjak, L

    2017-02-01

    Flax and Salba-chia seeds have risen in popularity owing to their favorable nutrient composition, including a high fiber content. Despite having comparable nutritional profiles, preliminary observations suggest differences in gelling properties, an attribute that may alter the kinetics of food digestion. Thus, we compared the effect of two seeds on postprandial glycemia and satiety scores. Fifteen healthy participants (M/F: 5/10; age: 23.9±3 years; BMI: 22.2±0.8 kg/m 2 ) were randomized to receive a 50 g glucose challenge, alone or supplemented with either 25 g ground Salba-chia or 31.5 g flax, on three separate occasions. Blood glucose samples and satiety ratings were collected at fasting and over 2-h postprandially. In addition, in vitro viscosity of the beverages was assessed utilizing standard rheological methodology. Both Salba-chia and flax reduced blood glucose area under the curve over 120 min by 82.5±19.7 mmol/l (P<0.001) and 60.0±19.7 mmol/l (P=0.014), respectively, relative to a glucose control. Salba-chia reduced peak glucose (-0.64±0.24 mmol/l; P=0.030) and increased time to peak (11.3±3.8 min; P=0.015) compared with flax. Salba-chia significantly reduced the mean ratings of desire to eat (-7±2 mm; P=0.005), prospective consumption (-7±2 mm; P=0.010) and overall appetite score (-6±2 mm; P=0.012), when compared with flax. The viscosity of Salba-chia, flax and control was 49.9, 2.5, and 0.002 Pa·s, respectively. Despite the similarities in nutritional composition, Salba-chia appears to have the ability to convert glucose into a slow-release carbohydrate and affect satiety to a greater extent than flax, possibly due to the higher fiber viscosity. Incorporation of either flax or Salba-chia into the diet may be beneficial, although use of Salba-chia may confer additional benefit.

  4. Randomized controlled study of CBT in bronchial asthma

    Directory of Open Access Journals (Sweden)

    Grover Naveen

    2007-01-01

    Full Text Available The aim of the present study was to find out efficacy of cognitive behavior therapy, as an adjunct to standard pharmacotherapy, in bronchial asthma. In a random-ized two-group design with pre-and post assessments, forty asthma patients were randomly allotted to two groups: self management group and cognitive behavior therapy group. Both groups were exposed to 6-8 weeks of intervention, asthma self management program and cognitive behavior therapy. Assessment measures used were-Semi structured interview schedule, Asthma Symptom Checklist, Asthma di-ary, Asthma Bother Profile, Hospital Anxiety & Depression Scale, AQLQ and Peak Expiratory Flow Rate. Within group comparison showed significant improvement in both groups at the post assessment. Between group comparisons showed that CBT group reported significantly greater change than that of SM group. Cognitive behavior therapy helps in improving the managment of asthma.

  5. Comparison of participants and non-participants in a randomized study of prevention of depression in patients with acute coronary syndrome

    DEFF Research Database (Denmark)

    Hansen, Baiba; Hanash, Jamal A.; Rasmussen, Alice

    2011-01-01

    Background: The prevalence of depression and anxiety in patients after acute coronary syndrome (ACS) is higher than in the general population. In a study on prevention of post-ACS depression, more than half of eligible patients declined participation. Aims: The aim of this study was to evaluate...

  6. A comparison of generalized multinomial logit, random parameters logit, wtp-space and latent class models to studying consumers' preferences for animal welfare

    OpenAIRE

    Kallas, Zein; Borrisser-Pairó,, Francesc; Martínez, Beatriz; Vieira, Ceferina; Panella-Riera, Nuria; Olivar, Maria Angels; Gil Roig, José María

    2016-01-01

    The European societies are requiring that animals to be raised as closely as possible to their natural conditions. The growing concerns about animal welfare is resulting in continuous modifications of regulations and policies that led to ban of a number of intensive farming methods. The European authorities consider the pig welfare as a priority issue. They are studying to ban surgical pig castration by 2018, which may seriously affect markets and consumers due to boar tainted-meat. This stud...

  7. A Comparison of the Number of Men Who Have Sex with Men among Rural-To-Urban Migrants with Non-Migrant Rural and Urban Residents in Wuhan, China: A GIS/GPS-Assisted Random Sample Survey Study

    Science.gov (United States)

    Chen, Xinguang; Yu, Bin; Zhou, Dunjin; Zhou, Wang; Gong, Jie; Li, Shiyue; Stanton, Bonita

    2015-01-01

    Background Mobile populations and men who have sex with men (MSM) play an increasing role in the current HIV epidemic in China and across the globe. While considerable research has addressed both of these at-risk populations, more effective HIV control requires accurate data on the number of MSM at the population level, particularly MSM among migrant populations. Methods Survey data from a random sample of male rural-to-urban migrants (aged 18-45, n=572) in Wuhan, China were analyzed and compared with those of randomly selected non-migrant urban (n=566) and rural counterparts (580). The GIS/GPS technologies were used for sampling and the survey estimation method was used for data analysis. Results HIV-related risk behaviors among rural-to-urban migrants were similar to those among the two comparison groups. The estimated proportion of MSM among migrants [95% CI] was 5.8% [4.7, 6.8], higher than 2.8% [1.2, 4.5] for rural residents and 1.0% [0.0, 2.4] for urban residents, respectively. Among these migrants, the MSM were more likely than non-MSM to be older in age, married, and migrated to more cities. They were also more likely to co-habit with others in rental properties located in new town and neighborhoods with fewer old acquaintances and more entertainment establishments. In addition, they were more likely to engage in commercial sex and less likely to consistently use condoms. Conclusion Findings of this study indicate that compared to rural and urban populations, the migrant population in Wuhan consists of a higher proportion of MSM who also exhibit higher levels of HIV-related risk behaviors. More effective interventions should target this population with a focus on neighborhood factors, social capital and collective efficacy for risk reduction. PMID:26241900

  8. Reversal of neuromuscular block with sugammadex: a comparison of the corrugator supercilii and adductor pollicis muscles in a randomized dose-response study.

    Science.gov (United States)

    Yamamoto, S; Yamamoto, Y; Kitajima, O; Maeda, T; Suzuki, T

    2015-08-01

    Neuromuscular monitoring using the corrugator supercilii muscle is associated with a number of challenges. The aim of this study was to assess reversal of a rocuronium-induced neuromuscular blockade with sugammadex according to monitoring either using the corrugator supercilii muscle or the adductor pollicis muscle. We hypothesized that a larger dose of sugammadex would be required to obtain a train-of-four (TOF) ratio of 1.0 with the corrugator supercilii muscle than with the adductor pollicis muscle. Forty patients aged 20-60 years and 40 patients aged ≥ 70 years were enrolled. After induction of anesthesia, we recorded the corrugator supercilii muscle response to facial nerve stimulation and the adductor pollicis muscle response to ulnar nerve stimulation using acceleromyography. All patients received 1 mg/kg rocuronium. When the first twitch (T1) of TOF recovered to 10% of control values at the corrugator supercilii, rocuronium infusion was commenced to maintain a T1 of 10% of the control at the corrugator supercilii. Immediately after discontinuation of rocuronium infusion, 2 mg/kg or 4 mg/kg of sugammadex was administered. The time for recovery to a TOF ratio of 1.0 and the number of patients not reaching a TOF ratio of 1.0 by 5 min at each dose and muscle was recorded. When neuromuscular block at the corrugator supercilii was maintained at a T1 of 10% of control, that at the adductor pollicis was deep (post-tetanic count ≤ 5). Sugammadex 4 mg/kg completely antagonized neuromuscular block at both muscles within 5 min. The time to a TOF ratio of 1.0 at the adductor pollicis was significantly longer in the group ≥ 70 years than the group 20-60 years (mean (SD): 178 (42.8) s vs. 120 (9.4) s, P sugammadex reversed neuromuscular blockade at the corrugator supercilii but not at the adductor pollicis, with 10 patients in the group 20-60 years and 8 patients in the group ≥ 70 years requiring an additional sugammadex (P

  9. Ultra low-dose chest CT using filtered back projection: Comparison of 80-, 100- and 120 kVp protocols in a prospective randomized study

    Energy Technology Data Exchange (ETDEWEB)

    Khawaja, Ranish Deedar Ali, E-mail: rkhawaja@mgh.harvard.edu [Division of Thoracic Radiology, MGH Imaging, Massachusetts General Hospital and Harvard Medical School, Boston (United States); Singh, Sarabjeet [Division of Thoracic Radiology, MGH Imaging, Massachusetts General Hospital and Harvard Medical School, Boston (United States); Madan, Rachna [Division of Thoracic Radiology, Brigham and Women' s Hospital and Harvard Medical School, Boston (United States); Sharma, Amita; Padole, Atul; Pourjabbar, Sarvenaz; Digumarthy, Subba; Shepard, Jo-Anne; Kalra, Mannudeep K. [Division of Thoracic Radiology, MGH Imaging, Massachusetts General Hospital and Harvard Medical School, Boston (United States)

    2014-10-15

    Highlights: • Filtered back projection technique enables acceptable image quality for chest CT examinations at 0.9 mGy (estimated effective dose of 0.5 mSv) for selected sizes of patients. • Lesion detection (such as solid non-calcified lung nodules) in lung parenchyma is optimal at 0.9 mGy, with limited visualization of thyroid nodules in FBP images. • Further dose reduction down to 0.4 mGy is possible for most patients undergoing follow-up chest CT for evaluation of larger lung nodules and GGOs. • Our results may help set the reference ALARA dose for chest CT examinations reconstructed with filtered back projection technique using the minimum possible radiation dose with acceptable image quality and lesion detection. - Abstract: Purpose: To assess lesion detection and diagnostic image quality of filtered back projection (FBP) reconstruction technique in ultra low-dose chest CT examinations. Methods and materials: In this IRB-approved ongoing prospective clinical study, 116 CT-image-series at four different radiation-doses were performed for 29 patients (age, 57–87 years; F:M – 15:12; BMI 16–32 kg/m{sup 2}). All patients provided written-informed-consent for the acquisitions of additional ultra low-dose (ULD) series on a 256-slice MDCT (iCT, Philips Healthcare). In-addition to their clinical standard-dose chest CT (SD, 120 kV mean CTDI{sub vol}, 6 ± 1 mGy), ULD-CT was subsequently performed at three-dose-levels (0.9 mGy [120 kV]; 0.5 mGy [100 kV] and 0.2 mGy [80 kV]). Images were reconstructed with FBP (2.5 mm * 1.25 mm) resulting into four-stacks: SD-FBP (reference-standard), FBP{sub 0.9}, FBP{sub 0.5}, and FBP{sub 0.2}. Four thoracic-radiologists from two-teaching-hospitals independently-evaluated data for lesion-detection and visibility-of-small-structures. Friedman's-non-parametric-test with post hoc Dunn's-test was used for data-analysis. Results: Interobserver-agreement was substantial between radiologists (k = 0.6–0.8). With

  10. Recovery of muscle function after deep neuromuscular block by means of diaphragm ultrasonography and adductor of pollicis acceleromyography with comparison of neostigmine vs. sugammadex as reversal drugs: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Cappellini, Iacopo; Picciafuochi, Fabio; Ostento, Daniele; Danti, Ginevra; De Gaudio, Angelo Raffaele; Adembri, Chiara

    2018-02-21

    The extensive use of neuromuscular blocking agents (NMBAs) during surgical procedures still leads to potential residual paralyzing effects in the postoperative period. Indeed, neuromuscular monitoring in an intra-operative setting is strongly advocated. Acetylcholinesterase inhibitors can reverse muscle block, but their short half-life may lead to residual curarization in the ward, especially when intermediate or long-acting NMBAs have been administered. Sugammadex is the first selective reversal drug for steroidal NMBAs; it has been shown to give full and rapid recovery of muscle strength, thus minimizing the occurrence of residual curarization. Acceleromyography of the adductor pollicis is the gold standard for detecting residual curarization, but it cannot be carried out on conscious patients. Ultrasonography of diaphragm thickness may reveal residual effects of NMBAs in conscious patients. This prospective, double-blind, single-center randomized controlled study will enroll patients (of American Society of Anesthesiologists physical status I-II, aged 18-80 years) who will be scheduled to undergo deep neuromuscular block with rocuronium for ear, nose, or throat surgery. The study's primary objective will be to compare the effects of neostigmine and sugammadex on postoperative residual curarization using two different tools: diaphragm ultrasonography and acceleromyography of the adductor pollicis. Patients will be extubated when the train-of-four ratio is > 0.9. Diaphragm ultrasonography will be used to evaluate the thickening fraction, which is the difference between the end expiratory thickness and the end inspiratory thickness, normalized to the end expiratory thickness. Ultrasonography will be performed before the initiation of general anesthesia, before extubation, and 10 and 30 min after discharging patients from the operating room. The secondary objective will be to compare the incidence of postoperative complications due to residual neuromuscular

  11. Interactive informed consent: randomized comparison with paper consents.

    Directory of Open Access Journals (Sweden)

    Michael C Rowbotham

    Full Text Available Informed consent is the cornerstone of human research subject protection. Many subjects sign consent documents without understanding the study purpose, procedures, risks, benefits, and their rights. Proof of comprehension is not required and rarely obtained. Understanding might improve by using an interactive system with multiple options for hearing, viewing and reading about the study and the consent form at the subject's own pace with testing and immediate feedback. This prospective randomized study compared the IRB-approved paper ICF for an actual clinical research study with an interactive presentation of the same study and its associated consent form using an iPad device in two populations: clinical research professionals, and patients drawn from a variety of outpatient practice settings. Of the 90 participants, 69 completed the online test and survey questions the day after the session (maximum 36 hours post-session. Among research professionals (n = 14, there was a trend (p = .07 in the direction of iPad subjects testing better on the online test (mean correct  =  77% compared with paper subjects (mean correct = 57%. Among patients (n = 55, iPad subjects had significantly higher test scores than standard paper consent subjects (mean correct = 75% vs 58%, p < .001. For all subjects, the total time spent reviewing the paper consent was 13.2 minutes, significantly less than the average of 22.7 minutes total on the three components to be reviewed using the iPad (introductory video, consent form, interactive quiz. Overall satisfaction and overall enjoyment slightly favored the interactive iPad presentation. This study demonstrates that combining an introductory video, standard consent language, and an interactive quiz on a tablet-based system improves comprehension of research study procedures and risks.

  12. Comparison of Preoperative Oral Ketorolac on Anesthetic Efficacy of Inferior Alveolar Nerve Block and Buccal and Lingual Infiltration with Articaine and Lidocaine in Patients with Irreversible Pulpitis: A Prospective, Randomized, Controlled, Double-blind Study.

    Science.gov (United States)

    Yadav, Meetu; Grewal, Mandeep S; Grewal, Stutee; Deshwal, Parul

    2015-11-01

    Irreversible pulpitis (IP) commonly results in decreased anesthetic efficacy of the inferior alveolar nerve block (IANB) for mandibular molar. It has been shown that supplementary buccal and/or lingual infiltration as well as premedication with ketorolac result in improved efficacy of the IANB. One hundred fifty emergency patients who had their lower first or/and second molar diagnosed with IP participated in the study. All patients were randomly divided into 2 major IANB groups: 1 group received 4% articaine with 1:100,000 epinephrine, and the other group received 2% lidocaine with 1:80,000 epinephrine. Each group was further divided into 3 subgroups of 25 each: (1) buccal and lingual infiltration with articaine and lidocaine, respectively; (2) preoperative oral medication of ketorolac; and (3) preoperative oral medication of ketorolac followed by buccal and lingual infiltration with articaine and lidocaine, respectively. Endodontic access was initiated 15 minutes after solution deposition, and all patients were required to have profound lip numbness. Success of the anesthetic was defined as none or mild pain on endodontic access and initial instrumentation. Statistical analysis was performed using multiple-comparison analysis of variance (Kruskal-Wallis) and t tests. Articaine IANB with infiltrations plus oral ketorolac premedication significantly increased the success rate to 76%. The success rate after the administration of an articaine IANB with infiltration injections was 64%, whereas with lidocaine it was 32% (P < .05). Premedication with ketorolac significantly increases the anesthetic efficacy of articaine IANB plus infiltration in mandibular molars with IP. Copyright © 2015 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  13. In vivo social comparison to a thin-ideal peer promotes body dissatisfaction: a randomized experiment.

    Science.gov (United States)

    Krones, Pamela G; Stice, Eric; Batres, Carla; Orjada, Kendra

    2005-09-01

    Although social comparison with media-portrayed thin-ideal images has been found to increase body dissatisfaction and negative affect, research has not yet tested whether social comparison with attractive peers in the real world produces similar effects. We randomly assigned 119 young women to interact either with a confederate who conformed to the thin ideal or one who conformed to the average body dimensions of women, within the context of an ostensive dating study. Exposure to the thin-ideal confederate resulted in an increase in body dissatisfaction but not negative affect or heart rate. Initial thin-ideal internalization, perceived sociocultural pressure, self-esteem, and observer-rated attractiveness did not moderate these effects. Results suggest that social comparative pressure to be thin fosters body dissatisfaction but may not promote negative affect. 2005 by Wiley Periodicals, Inc.

  14. The High/Scope Perry Preschool Study: A Case Study in Random Assignment.

    Science.gov (United States)

    Schweinhart, Lawrence J.

    2000-01-01

    Studied the long-term benefits of preschool programs for young children living in poverty in the High/Scope Perry Preschool Study, which examined the lives of 123 African Americans randomly divided into a preschool treatment group and a no-preschool comparison group. Cost-benefit analyses of data on these students to age 27 show beneficial effects…

  15. Network meta-analysis incorporating randomized controlled trials and non-randomized comparative cohort studies for assessing the safety and effectiveness of medical treatments: challenges and opportunities

    OpenAIRE

    Cameron, Chris; Fireman, Bruce; Hutton, Brian; Clifford, Tammy; Coyle, Doug; Wells, George; Dormuth, Colin R.; Platt, Robert; Toh, Sengwee

    2015-01-01

    Network meta-analysis is increasingly used to allow comparison of multiple treatment alternatives simultaneously, some of which may not have been compared directly in primary research studies. The majority of network meta-analyses published to date have incorporated data from randomized controlled trials (RCTs) only; however, inclusion of non-randomized studies may sometimes be considered. Non-randomized studies can complement RCTs or address some of their limitations, such as short follow-up...

  16. Comparison of a Simple Angiographic Approach With a Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery Score-Based Approach for Left Main Coronary Artery Stenting: A Pooled Analysis of Serial PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease) Studies.

    Science.gov (United States)

    Lee, Pil Hyung; Lee, Jong-Young; Lee, Cheol Whan; Kim, Seon-Ok; Ahn, Jung-Min; Park, Duk-Woo; Kang, Soo-Jin; Lee, Seung-Whan; Kim, Young-Hak; Park, Seong-Wook; Park, Seung-Jung

    2018-01-01

    The applicability of Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery scores to left main coronary artery disease (CAD) has been questioned. A simplified alternative is needed for guiding decision making. We evaluated the prognostic value of a simplified angiographic classification in comparison with a Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery score-based approach for patients with left main CAD undergoing drug-eluting stent implantation. The proposed approach classified left main CAD as either extensive (n=819), defined as left main bifurcation lesions with an involvement of ostial left circumflex artery or as any left main lesion plus multivessel CAD, or limited (n=453), defined as ostial/midshaft lesions or left main bifurcation lesions without an involvement of ostium of left circumflex artery, alone or plus 1-vessel disease. The databases from 4 prospective Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease studies were pooled, and the primary outcome was a major adverse cardiac event, defined as death, myocardial infarction, or repeat revascularization. During follow-up (median 38 months; interquartile range, 36-61 months), the risk for major adverse cardiac event was significantly higher with extensive than with limited left main CAD (adjusted hazard ratio, 2.13; 95% confidence interval, 1.54-2.94; P Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery score tertiles did not effectively stratify these 2 outcome measures. Compared with Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery scores, the simpler angiographic approach provided better discrimination for future cardiovascular events in patients with left main CAD undergoing drug-eluting stent implantation. © 2018 American Heart Association, Inc.

  17. Comparison of efficacy and tolerance between combination therapy and monotherapy as first-line chemotherapy in elderly patients with advanced gastric cancer: Study protocol for a randomized controlled trial.

    Science.gov (United States)

    Lee, Keun-Wook; Zang, Dae Young; Ryu, Min-Hee; Kim, Ki Hyang; Kim, Mi-Jung; Han, Hye Sook; Koh, Sung Ae; Park, Jin Hyun; Kim, Jin Won; Nam, Byung-Ho; Choi, In Sil

    2017-12-01

    The combination of a fluoropyrimidine [5-fluorouracil (5-FU), capecitabine, or S-1] with a platinum analog (cisplatin or oxaliplatin) is the most widely accepted first-line chemotherapy regimen for metastatic or recurrent advanced gastric cancer (AGC), based on the results of clinical trials. However, there is little evidence to guide chemotherapy for elderly patients with AGC because of under-representation of this age group in clinical trials. Thus, the aim of this study is to determine the optimal chemotherapy regimen for elderly patients with AGC by comparing the efficacies and safeties of combination therapy versus monotherapy as first-line chemotherapy. This study is a randomized, controlled, multicenter, phase III trial. A total of 246 elderly patients (≥70 years old) with metastatic or recurrent AGC who have not received previous palliative chemotherapy will be randomly allocated to a combination therapy group or a monotherapy group. Patients randomized to the combination therapy group will receive fluoropyrimidine plus platinum combination chemotherapy (capecitabine/cisplatin, S-1/cisplatin, capecitabine/oxaliplatin, or 5-FU/oxaliplatin), and those randomized to the monotherapy group will receive fluoropyrimidine monotherapy (capecitabine, S-1, or 5-FU). The primary outcome is the overall survival of patients in each treatment group. The secondary outcomes include progression-free survival, response rate, quality of life, and safety. We are conducting this pragmatic trial to determine whether elderly patients with AGC will obtain the same benefit from chemotherapy as younger patients. We expect that this study will help guide decision-making for the optimal treatment of elderly patients with AGC.

  18. A comparison of the conditional inference survival forest model to random survival forests based on a simulation study as well as on two applications with time-to-event data.

    Science.gov (United States)

    Nasejje, Justine B; Mwambi, Henry; Dheda, Keertan; Lesosky, Maia

    2017-07-28

    Random survival forest (RSF) models have been identified as alternative methods to the Cox proportional hazards model in analysing time-to-event data. These methods, however, have been criticised for the bias that results from favouring covariates with many split-points and hence conditional inference forests for time-to-event data have been suggested. Conditional inference forests (CIF) are known to correct the bias in RSF models by separating the procedure for the best covariate to split on from that of the best split point search for the selected covariate. In this study, we compare the random survival forest model to the conditional inference model (CIF) using twenty-two simulated time-to-event datasets. We also analysed two real time-to-event datasets. The first dataset is based on the survival of children under-five years of age in Uganda and it consists of categorical covariates with most of them having more than two levels (many split-points). The second dataset is based on the survival of patients with extremely drug resistant tuberculosis (XDR TB) which consists of mainly categorical covariates with two levels (few split-points). The study findings indicate that the conditional inference forest model is superior to random survival forest models in analysing time-to-event data that consists of covariates with many split-points based on the values of the bootstrap cross-validated estimates for integrated Brier scores. However, conditional inference forests perform comparably similar to random survival forests models in analysing time-to-event data consisting of covariates with fewer split-points. Although survival forests are promising methods in analysing time-to-event data, it is important to identify the best forest model for analysis based on the nature of covariates of the dataset in question.

  19. A comparison of the conditional inference survival forest model to random survival forests based on a simulation study as well as on two applications with time-to-event data

    Directory of Open Access Journals (Sweden)

    Justine B. Nasejje

    2017-07-01

    Full Text Available Abstract Background Random survival forest (RSF models have been identified as alternative methods to the Cox proportional hazards model in analysing time-to-event data. These methods, however, have been criticised for the bias that results from favouring covariates with many split-points and hence conditional inference forests for time-to-event data have been suggested. Conditional inference forests (CIF are known to correct the bias in RSF models by separating the procedure for the best covariate to split on from that of the best split point search for the selected covariate. Methods In this study, we compare the random survival forest model to the conditional inference model (CIF using twenty-two simulated time-to-event datasets. We also analysed two real time-to-event datasets. The first dataset is based on the survival of children under-five years of age in Uganda and it consists of categorical covariates with most of them having more than two levels (many split-points. The second dataset is based on the survival of patients with extremely drug resistant tuberculosis (XDR TB which consists of mainly categorical covariates with two levels (few split-points. Results The study findings indicate that the conditional inference forest model is superior to random survival forest models in analysing time-to-event data that consists of covariates with many split-points based on the values of the bootstrap cross-validated estimates for integrated Brier scores. However, conditional inference forests perform comparably similar to random survival forests models in analysing time-to-event data consisting of covariates with fewer split-points. Conclusion Although survival forests are promising methods in analysing time-to-event data, it is important to identify the best forest model for analysis based on the nature of covariates of the dataset in question.

  20. Comparison of torsional and microburst longitudinal phacoemulsification: a prospective, randomized, masked clinical trial.

    Science.gov (United States)

    Vasavada, Abhay R; Raj, Shetal M; Patel, Udayan; Vasavada, Vaishali; Vasavada, Viraj

    2010-01-01

    To compare intraoperative performance and postoperative outcome of three phacoemulsification technologies in patients undergoing microcoaxial phacoemulsification through 2.2-mm corneal incisions. The prospective, randomized, single-masked study included 360 eyes randomly assigned to torsional (Infiniti Vision System; Alcon Laboratories, Fort Worth, TX), microburst with longitudinal (Infiniti), or microburst with longitudinal (Legacy Everest, Alcon Laboratories) ultrasound. Assessments included surgical clock time, fluid volume, and intraoperative complications, central corneal thickness on day 1 and months 1 and 3 postoperatively, and endothelial cell density at 3 months postoperatively. Comparisons among groups were conducted. Torsional ultrasound required significantly less surgical clock time and fluid volume than the other groups. There were no intraoperative complications. Change in central corneal thickness and endothelial cell loss was significantly lower in the torsional ultrasound group at all postoperative visits (P < .001, Kruskal-Wallis test) compared to microburst longitudinal ultrasound modalities. Torsional ultrasound demonstrated quantitatively superior intraoperative performance and showed less increase in corneal thickness and less endothelial cell loss compared to microburst longitudinal ultrasound. Copyright 2010, SLACK Incorporated.

  1. Operating characteristics of a partial-block randomized crossover bioequivalence study for dutasteride, a drug with a long half-life: investigation through simulation and comparison with final results.

    Science.gov (United States)

    Cai, Gengqian; Thiessen, Jake J; Baidoo, Charlotte A; Fossler, Michael J

    2010-10-01

    Studies to establish bioequivalence (BE) of a drug are important elements in support of drug applications. A typical BE study is conducted as a single dose, randomized, 2-period crossover design. For drugs with long half lives (≥ 48 hours) and evaluation of multiple BE objectives in 1 trial, this design may not be adequate. A parallel design may then be a more appropriate choice. However, parallel designs require increased sample size, which can become substantial. One option that is a compromise between the complete randomized block design and the parallel design is a partial-block crossover design. This approach came about during the development of a combination of dutasteride and tamsulosin. Previous experience with performing single-dose dutasteride studies suggested that 28 days of washout is needed between treatments because of its half-life of 7-9 days. Simulations were performed to assess the operating characteristics of this design using a previously developed PK model. Four scenarios were developed, and each scenario was simulated 500 times. The results showed that this design demonstrated acceptable consumer and producer risk. Partial-block crossover designs should be considered for studies when the half-life of the drug is long and there are more than 2 periods.

  2. A randomized, prospective, comparison study of a mixture of acacia fiber, psyllium fiber, and fructose vs polyethylene glycol 3350 with electrolytes for the treatment of chronic functional constipation in childhood.

    Science.gov (United States)

    Quitadamo, Paolo; Coccorullo, Paola; Giannetti, Eleonora; Romano, Claudio; Chiaro, Andrea; Campanozzi, Angelo; Poli, Emanuela; Cucchiara, Salvatore; Di Nardo, Giovanni; Staiano, Annamaria

    2012-10-01

    To compare the effectiveness of a mixture of acacia fiber, psyllium fiber, and fructose (AFPFF) with polyethylene glycol 3350 combined with electrolytes (PEG+E) in the treatment of children with chronic functional constipation (CFC); and to evaluate the safety and effectiveness of AFPFF in the treatment of children with CFC. This was a randomized, open label, prospective, controlled, parallel-group study involving 100 children (M/F: 38/62; mean age ± SD: 6.5 ± 2.7 years) who were diagnosed with CFC according to the Rome III Criteria. Children were randomly divided into 2 groups: 50 children received AFPFF (16.8 g daily) and 50 children received PEG+E (0.5 g/kg daily) for 8 weeks. Primary outcome measures were frequency of bowel movements, stool consistency, fecal incontinence, and improvement of other associated gastrointestinal symptoms. Safety was assessed with evaluation of clinical adverse effects and growth measurements. Compliance rates were 72% for AFPFF and 96% for PEG+E. A significant improvement of constipation was seen in both groups. After 8 weeks, 77.8% of children treated with AFPFF and 83% of children treated with PEG+E had improved (P = .788). Neither PEG+E nor AFPFF caused any clinically significant side effects during the entire course of the study period. In this randomized study, we did not find any significant difference between the efficacy of AFPFF and PEG+E in the treatment of children with CFC. Both medications were proved to be safe for CFC treatment, but PEG+E was better accepted by children. Copyright © 2012 Mosby, Inc. All rights reserved.

  3. Statistical power in parallel group point exposure studies with time-to-event outcomes: an empirical comparison of the performance of randomized controlled trials and the inverse probability of treatment weighting (IPTW) approach.

    Science.gov (United States)

    Austin, Peter C; Schuster, Tibor; Platt, Robert W

    2015-10-15

    Estimating statistical power is an important component of the design of both randomized controlled trials (RCTs) and observational studies. Methods for estimating statistical power in RCTs have been well described and can be implemented simply. In observational studies, statistical methods must be used to remove the effects of confounding that can occur due to non-random treatment assignment. Inverse probability of treatment weighting (IPTW) using the propensity score is an attractive method for estimating the effects of treatment using observational data. However, sample size and power calculations have not been adequately described for these methods. We used an extensive series of Monte Carlo simulations to compare the statistical power of an IPTW analysis of an observational study with time-to-event outcomes with that of an analysis of a similarly-structured RCT. We examined the impact of four factors on the statistical power function: number of observed events, prevalence of treatment, the marginal hazard ratio, and the strength of the treatment-selection process. We found that, on average, an IPTW analysis had lower statistical power compared to an analysis of a similarly-structured RCT. The difference in statistical power increased as the magnitude of the treatment-selection model increased. The statistical power of an IPTW analysis tended to be lower than the statistical power of a similarly-structured RCT.

  4. Comparison of efficacy of transversus abdominis plane block and iliohypogastric/ilioinguinal nerve block for postoperative pain management in patients undergoing inguinal herniorrhaphy with spinal anesthesia: a prospective randomized controlled open-label study.

    Science.gov (United States)

    Okur, Onur; Tekgul, Zeki Tuncel; Erkan, Nazif

    2017-10-01

    The purpose of this study was to compare the effects of lateral abdominal transversus abdominis plane block (TAP block) and iliohypogastric/ilioinguinal nerve block (IHINB) under ultrasound guidance for postoperative pain management of inguinal hernia repair. Secondary purposes were to compare the complication rates of the two techniques and to examine the effects of TAP block and IHINB on chronic postoperative pain. This was a prospective randomized controlled open-label study. After approval of the Research Ethics Board, a total of 90 patients were allocated to three groups of 30 by simple randomized sampling as determined with a priori power analysis. Peripheral nerve blocks (TAP block or IHINB) were administered to patients following subarachnoid block according to their allocated group. Patient pain scores, additional analgesic requirements and complication rates were recorded periodically and compared. Pain scores were significantly lower in the study groups (p block group [GT] 266.6 ± 119.7 min; IHINB group [GI] 247.2 ± 128.7 min; and control group [GC] 79.1 ± 66.2 min; p block or IHINB for patients undergoing inguinal herniorrhaphy reduces the intensity of both acute and chronic postoperative pain and additional analgesic requirements.

  5. Comparison of Effect of Oral Premedication with Ibuprofen or Dexamethasone on Anesthetic Efficacy of Inferior Alveolar Nerve Block in Patients with Irreversible Pulpitis: A Prospective, Randomized, Controlled, Double-blind Study.

    Science.gov (United States)

    Bidar, Maryam; Mortazavi, Soheil; Forghani, Maryam; Akhlaghi, Saeed

    2017-01-01

    The purpose of this prospective, randomized, double-blind, placebo-controlled study was to determine the effect of preoperative oral administration of ibuprofen or dexamethasone on the success rate of inferior alveolar nerve block (IANB) in patients with symptomatic irreversible pulpitis. Seventy-eight patients with irreversible pulpitis were randomly divided into 3 groups (26 per group) and given one of the following at 1 hr prior to performing local anesthesia: a placebo; 400 mg ibuprofen; or 4 mg dexamethasone. Each patient recorded their pain level on a visual analog scale before taking the medication or placebo, at 15 min after completion of IANB, and during treatment if pain occurred. The success of the anesthesia was defined as no or mild pain at any stage during the endodontic procedure. The success rate of the IANB was 38.5, 73.1, and 80.8% with the placebo, ibuprofen, and dexamethasone, respectively. Both ibuprofen and dexamethasone were significantly more effective than the placebo. No significant difference was observed, however, between the two experimental medications in terms of effectiveness. The results of the present study suggest that premedication with ibuprofen or dexamethasone increases the success rate of an IANB in patients with symptomatic irreversible pulpitis in the mandibular molars.

  6. Comparison of the effectiveness of three manual physical therapy techniques in a subgroup of patients with low back pain who satisfy a clinical prediction rule: Study protocol of a randomized clinical trial [NCT00257998

    Directory of Open Access Journals (Sweden)

    Childs John D

    2006-02-01

    Full Text Available Abstract Background Recently a clinical prediction rule (CPR has been developed and validated that accurately identifies patients with low back pain (LBP that are likely to benefit from a lumbo-pelvic thrust manipulation. The studies that developed and validated the rule used the identical manipulation procedure. However, recent evidence suggests that different manual therapy techniques may result similar outcomes. The purpose of this study is to investigate the effectiveness of three different manual therapy techniques in a subgroup of patient with low back pain that satisfy the CPR. Methods/Design Consecutive patients with LBP referred to physical therapy clinics in one of four geographical locations who satisfy the CPR will be invited to participate in this randomized clinical trial. Subjects who agree to participate will undergo a standard evaluation and complete a number of patient self-report questionnaires including the Oswestry Disability Index (OSW, which will serve as the primary outcome measure. Following the baseline examination patients will be randomly assigned to receive the lumbopelvic manipulation used in the development of the CPR, an alternative lumbar manipulation technique, or non-thrust lumbar mobilization technique for the first 2 visits. Beginning on visit 3, all 3 groups will receive an identical standard exercise program for 3 visits (visits 3,4,5. Outcomes of interest will be captured by a therapist blind to group assignment at 1 week (3rd visit, 4 weeks (6th visit and at a 6-month follow-up. The primary aim of the study will be tested with analysis of variance (ANOVA using the change in OSW score from baseline to 4-weeks (OSWBaseline – OSW4-weeks as the dependent variable. The independent variable will be treatment with three levels (lumbo-pelvic manipulation, alternative lumbar manipulation, lumbar mobilization. Discussion This trial will be the first to investigate the effectiveness of various manual therapy

  7. Comparison of latanoprost with fixed-combination dorzolamide and timolol in adult patients with elevated intraocular pressure: an eight-week, randomized, open-label, parallel-group, multicenter study in Latin America.

    Science.gov (United States)

    Susanna, Remo; Sussana, Remo; Sheu, Wang-Pui

    2004-05-01

    The newer ocular hypotensive agents available to treat glaucoma and ocular hypertension (OHT) include latanoprost, a prostaglandin F(2alpha) analogue, and the fixed combination of dorzolamide hydrochloride, a carbonic anhydrase inhibitor, and timolol maleate, a beta-blocker. The aim of this study was to compare the efficacy and tolerability of latanoprost with that of the fixed combination of dorzolamide and timolol over 8 weeks. This interventional, 8-week, randomized, open-label, parallel-group study was conducted at 18 centers in 6 Latin American countries. Patients with unilateral or bilateral primary open-angle, pigmentary, or exfoliative glaucoma or OHT were randomized to receive latanoprost, 1 drop in the affected eye QD (evening), or fixed-combination dorzolamide/timolol, 1 drop in the affected eye BID (morning and evening). Medications were self-administered, 1 drop per affected eye. At baseline and week 8, intraocular pressure (IOP) was measured 3 times each at 8:30 am, 10:00 am, 2:00 pm, and 5:00 pm and after the water-drinking test, which estimates the IOP peak of diurnal tension curve, performed following the 5:00 pm IOP assessment. The primary efficacy outcome was change in diurnal IOP (the mean of IOP measurements) from baseline to week 8. Adverse effect (AE) data were recorded at each visit. A total of 229 patients were randomized (latanoprost, n = 112; dorzolamide/timolol, n = 117). Mean baseline diurnal IOP values were similar between the 2 groups. Mean (SD) diurnal IOP reductions at week 8 before the water-drinking test were 6.9 (3.0) mm Hg for the latanoprost group and 6.4 (3.2) mm Hg for the dorzolamide/timolol group. Mean IOP values were similar at all time points except at 5:00 pm, when levels were significantly lower in latanoprost-treated patients (P = 0.025). After the water-drinking test, the increase in IOP values was similar between groups at baseline but lower in latanoprost-treated patients at week 8 (adjusted difference, 1.08 mm Hg

  8. Comparison of the safety and immunogenicity of live attenuated and inactivated hepatitis A vaccine in healthy Chinese children aged 18 months to 16 years: results from a randomized, parallel controlled, phase IV study.

    Science.gov (United States)

    Ma, F; Yang, J; Kang, G; Sun, Q; Lu, P; Zhao, Y; Wang, Z; Luo, J; Wang, Z

    2016-09-01

    For large-scale immunization of children with hepatitis A (HA) vaccines in China, accurately designed studies comparing the safety and immunogenicity of the live attenuated HA vaccine (HA-L) and inactivated HA vaccine (HA-I) are necessary. A randomized, parallel controlled, phase IV clinical trial was conducted with 6000 healthy children aged 18 months to 16 years. HA-L or HA-I was administered at a ratio of 1: 1 to randomized selected participants. The safety and immunogenicity were evaluated. Both HA-L and HA-I were well tolerated by all participants. The immunogenicity results showed that the seroconversion rates (HA-L versus HA-I: 98.0% versus 100%, respectively, p >0.05), and geometric mean concentrations in participants negative for antibodies against HA virus IgG (anti-HAV IgG) before vaccination did not differ significantly between the two types of vaccines (HA-L versus HA-I first dose: 898.9 versus 886.2 mIU/mL, respectively, p >0.05). After administration of the booster dose of HA-I, the geometric mean concentrations of anti-HAV IgG (HA-I booster dose: 2591.2 mIU/mL) was higher than that after the first dose (p children. The effects of long-term immunogenicity after natural exposure to wild-type HA virus and the possibility of mutational shifts of the live vaccine virus in the field need to be studied in more detail. Copyright © 2016. Published by Elsevier Ltd.

  9. Comparison of the Effects of Religious Cognitive Behavioral Therapy (RCBT), Cognitive Behavioral Therapy (CBT), and Sertraline on Depression and Anxiety in Patients after Coronary Artery Bypass Graft Surgery: Study Protocol for a Randomized Controlled Trial.

    Science.gov (United States)

    Hosseini, Seyed Hamzeh; Rafiei, Alireza; Gaemian, Ali; Tirgari, Abdolhakim; Zakavi, Aliasghar; Yazdani, Jamshid; Bolhari, Jafar; Golzari, Mahmood; Esmaeili Douki, Zahra; Vaezzadeh, Nazanin

    2017-07-01

    Objective: The present study aimed at comparing the effects of Religious Cognitive Behavioral Therapy (RCBT), Cognitive Behavioral Therapy (CBT), and sertraline on depression, anxiety, biomarker levels, and quality of life in patients after coronary artery bypass graft (CABG) surgery. Method: This was a randomized controlled trial with parallel groups. A total of 160 patients after CABG surgery will be screened for anxiety and depression according to clinical interviews based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria and Hospital Anxiety Depression Scale (HADS) scores (≥ 8). To assess religious attitude, Golriz and Baraheni's Religious Attitude questionnaire will be used. Participants will be randomly allocated to 4 groups of 40 including 3 intervention groups (RCBT, CBT, and sertraline) and 1 control group (usual care). RCBT and CBT programs will consist of 12 one-hour weekly sessions. The participants in the pharmacological intervention group will receive 25-200 mg/d of sertraline for 3 months. The Short Form-36 Health Survey (SF-36) will be administered to assess the patients' quality of life. Blood samples will be taken and biomarker levels will be determined using the enzyme-linked immunosorbent assay (ELISA). The primary outcome will be reduction in anxiety and depression scores after the interventions. The secondary outcomes will be increase in quality of life scores and normalized biomarker levels after the interventions. Discussion: If RCBT is found to be more effective than the other methods; it can be used to improve patients' health status after CABG surgery. Irct ID: IRCT201404122898N5.

  10. Comparison of preoperative nepafenac (0.1%) and flurbiprofen (0.03%) eye drops in maintaining mydriasis during small incision cataract surgery in patients with senile cataract: A randomized, double-blind study.

    Science.gov (United States)

    Sarkar, Saumya; Mondal, Kanchan Kumar; Roy, Sukalyan Saha; Gayen, Sharmistha; Ghosh, Abhishek; De, Radha Raman

    2015-01-01

    This study compared the effectiveness of prophylactic administration of topical flurbiprofen 0.03% and nepafenac 0.1% in maintaining mydriasis during small incision cataract surgery (SICS). This study was a prospective, randomized, double-blind comparative study in adult cataract patients given topical flurbiprofen or nepafenac prior to SICS and capsular bag intraocular lens (IOL) implantation at a tertiary care hospital. Horizontal and vertical diameters of pupil were measured at the beginning and end of surgery, and the mean values were compared across the two groups. Unpaired t-test and Fisher's exact test were used to analyse the results. A total of 70 eyes of cataract surgery patients, 33 males and 37 females, with a mean age of 58.5 ± 11.24 years, were included in the study. The mean horizontal and vertical diameters of the two groups were similar at the start of surgery. Significant differences were seen after IOL implantation, with the nepafenac group having the larger mean diameters in both horizontal (P = 0.03) and vertical (P = 0.04) pupillary measurements. Topical nepafenac has been shown to be a more effective inhibitor of meiosis during SICS and provides a more stable mydriatic effect compared to topical flurbiprofen.

  11. Randomized comparison of total laparoscopic, laparoscopically assisted vaginal and vaginal hysterectomies for myomatous uteri.

    Science.gov (United States)

    Sesti, Francesco; Cosi, Veronica; Calonzi, Francesca; Ruggeri, Velia; Pietropolli, Adalgisa; Di Francesco, Lucia; Piccione, Emilio

    2014-09-01

    To compare the operative data and early postoperative outcomes of total laparoscopic hysterectomy (TLH), laparoscopically assisted vaginal hysterectomy (LAVH) and vaginal hysterectomy (VH). One hundred and eight women requiring hysterectomy for enlarged myomatous uterus were randomly allocated into three treatment arms: TLH (n = 36); LAVH (n = 36); VH (n = 36). Randomization procedure was based on a computer-generated list. The primary outcome was the discharge time comparison. The secondary outcomes were operating time, blood loss, paralytic ileus time, intraoperative complications, postoperative pain, and early postoperative complications. The mean discharge time was shorter after VH than after LAVH and TLH (P = 0.001). Operating time significantly influenced the discharge time, considered as a dependent variable in general linear model analysis (P = 0.006). In contrast, blood loss did not influence the discharge time (P = 0.55).The mean operating time was significantly shorter in VH than in TLH and LAVH groups (P = 0.000).The intraoperative blood loss was greater during LAVH than during TLH and VH (P = 0.000).Paralytic ileus time was shorter after VH than after TLH and LAVH (P = 0.000). No intraoperative complications or conversion to laparotomy occurred. VH was the faster operative technique with smaller blood loss and shorter discharge time compared with the others two techniques. So, VH should be considered the preferred approach in patients with enlarged myomatous uteri. When VH is not feasible or salpingo-oophorectomy is required, LAVH or TLH should be considered as valid alternatives. It is necessary to continue prospective comparative studies between the various surgical options to identify the best approach for hysterectomy in each single woman.

  12. [Comparison on Endoscopic Hemoclip and Hemoclip Combination Therapy in Non-variceal Upper Gastrointestinal Bleeding Patients Based on Clinical Practice Data: Is There Difference between Prospective Cohort Study and Randomized Study?].

    Science.gov (United States)

    Lee, Su Hyun; Jung, Jin Tae; Lee, Dong Wook; Ha, Chang Yoon; Park, Kyung Sik; Lee, Si Hyung; Yang, Chang Heon; Park, Youn Sun; Jeon, Seong Woo

    2015-08-01

    Endoscopic hemoclip application is an effective and safe method of endoscopic hemostasis. We conducted a multicenter retrospective study on hemoclip and hemoclip combination therapy based on prospective cohort database in terms of hemostatic efficacy not in clinical trial but in real clinical practice. Data on endoscopic hemostasis for non-variceal upper gastrointestinal bleeding (NVUGIB) were prospectively collected from February 2011 to December 2013. Among 1,584 patients with NVUGIB, 186 patients treated with hemoclip were enrolled in this study. Subjects were divided into three groups: Group 1 (n = 62), hemoclipping only; group 2 (n = 88), hemoclipping plus epinephrine injection; and group 3 (n = 36), hemocliping and epinephrine injection plus other endoscopic hemostatic modalities. Primary outcomes included rebleeding, other therapeutic management, hospitalization period, fasting period and mortality. Secondary outcomes were bleeding associated mortality and overall mortality. Active bleeding and peptic ulcer bleeding were more common in group 3 than in group 1 and in group 2 (p bleeding associated mortality and total mortality) were not different among groups. Combination therapy of epinephrine injection and other modalities with hemoclips did not show advantage over hemoclipping alone in this prospective cohort study. However, there is a tendency to perform combination therapy in active bleeding which resulted in equivalent hemostatic success rate, and this reflects the role of combination therapy in clinical practice.

  13. A randomized comparison between league tables and funnel plots to inform health care decision-making.

    Science.gov (United States)

    Anell, Anders; Hagberg, Oskar; Liedberg, Fredrik; Ryden, Stefan

    2016-12-01

    Comparison of provider performance is commonly used to inform health care decision-making. Little attention has been paid to how data presentations influence decisions. This study analyzes differences in suggested actions by decision-makers informed by league tables or funnel plots. Decision-makers were invited to a survey and randomized to compare hospital performance using either league tables or funnel plots for four different measures within the area of cancer care. For each measure, decision-makers were asked to suggest actions towards 12-16 hospitals (no action, ask for more information, intervene) and provide feedback related to whether the information provided had been useful. Swedish health care. Two hundred and twenty-one decision-makers at administrative and clinical levels. Data presentations in the form of league tables or funnel plots. Number of actions suggested by participants. Proportion of appropriate actions. For all four measures, decision-makers tended to suggest more actions based on the information provided in league tables compared to funnel plots (44% vs. 21%, P decision-makers more often missed to react even when appropriate. The form of data presentation had an influence on decision-making. With league tables, decision-makers tended to suggest more actions compared to funnel plots. A difference in sensitivity and specificity conditioned by the form of presentation could also be identified, with different implications depending on the purpose of comparisons. Explanations and visualization aids are needed to support appropriate actions. © The Author 2016. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  14. A robust random number generator based on differential comparison of chaotic laser signals.

    Science.gov (United States)

    Zhang, Jianzhong; Wang, Yuncai; Liu, Ming; Xue, Lugang; Li, Pu; Wang, Anbang; Zhang, Mingjiang

    2012-03-26

    We experimentally realize a robust real-time random number generator by differentially comparing the signal from a chaotic semiconductor laser and its delayed signal through a 1-bit analog-to-digital converter. The probability density distribution of the output chaotic signal based on the differential comparison method possesses an extremely small coefficient of Pearson's median skewness (1.5 × 10⁻⁶), which can yield a balanced random sequence much easily than the previously reported method that compares the signal from the chaotic laser with a certain threshold value. Moveover, we experimently demonstrate that our method can stably generate good random numbers at rates of 1.44 Gbit/s with excellent immunity from external perturbations while the previously reported method fails.

  15. Comparison of insulin lispro mix 25 with insulin lispro mix 50 as insulin starter in Chinese patients with type 2 diabetes mellitus (CLASSIFY study): Subgroup analysis of a Phase 4 open-label randomized trial.

    Science.gov (United States)

    Su, Qing; Liu, Chao; Zheng, Hongting; Zhu, Jun; Li, Peng Fei; Qian, Lei; Yang, Wen Ying

    2017-06-01

    Premixed insulins are recommended starter insulins in Chinese patients after oral antihyperglycemic medication (OAM) failure. In the present study, we compared the efficacy and safety of insulin lispro mix 25 (LM25) twice daily (b.i.d.) and insulin lispro mix 50 (LM50) b.i.d. as a starter insulin regimen in Chinese patients with type 2 diabetes mellitus (T2DM) who had inadequate glycemic control with OAMs. The primary efficacy outcome in the present open-label parallel randomized clinical trial was change in HbA1c from baseline to 26 weeks. Patients were randomized in a ratio of 1:  1 to LM25 (n = 80) or LM50 (n = 76). A mixed-effects model with repeated measures was used to analyze continuous variables. The Cochran-Mantel-Haenszel test with stratification factor was used to analyze categorical variables. At the end of the study, LM50 was more efficacious than LM25 in reducing mean HbA1c levels (least-squares [LS] mean difference 0.48; 95 % confidence interval [CI] 0.22, 0.74; P 1). More subjects in the LM50 than LM25 group achieved HbA1c targets of 1) or ≤6.5 % (52.6 % vs 20.0 %; P 1). Furthermore, LM50 was more effective than LM25 at reducing HbA1c in patients with baseline HbA1c, blood glucose excursion, and postprandial glucose greater than or equal to median levels (P ≤ 0.001). The rate and incidence of hypoglycemic episodes and increase in weight at the end of the study were similar between treatment groups. In Chinese patients with T2DM, LM50 was more efficacious than LM25 as a starter insulin. © 2016 The Authors. Journal of Diabetes published by John Wiley & Sons Australia, Ltd and Ruijin Hospital, Shanghai Jiaotong University School of Medicine.

  16. Comparison of two modes of vitamin B12 supplementation on neuroconduction and cognitive function among older people living in Santiago, Chile: a cluster randomized controlled trial. a study protocol [ISRCTN 02694183

    Directory of Open Access Journals (Sweden)

    Brito Alex

    2011-09-01

    Full Text Available Abstract Background Older people have a high risk of vitamin B12 deficiency; this can lead to varying degrees of cognitive and neurological impairment. CBL deficiency may present as macrocytic anemia, subacute combined degeneration of the spinal cord, or as neuropathy, but is often asymptomatic in older people. Less is known about subclinical vitamin B12 deficiency and concurrent neuroconduction and cognitive impairment. A Programme of Complementary Feeding for the Older Population (PACAM in Chile delivers 2 complementary fortified foods that provide approximately 1.4 μg/day of vitamin B12 (2.4 μg/day elderly RDA. The aim of the present study is to assess whether supplementation with vitamin B12 will improve neuroconduction and cognitive function in older people who have biochemical evidence of vitamin B12 insufficiency in the absence of clinical deficiency. Methods We designed a cluster double-blind placebo-controlled trial involving community dwelling people aged 70-79 living in Santiago, Chile. We randomized 15 clusters (health centers involving 300 people (20 per cluster. Each cluster will be randomly assigned to one of three arms: a a 1 mg vitamin B12 pill taken daily and a routine PACAM food; b a placebo pill and the milk-PACAM food fortified to provide 1 mg of vitamin B12; c the routine PACAM food and a placebo pill. The study has been designed as an 18 month follow up period. The primary outcomes assessed at baseline, 4, 9 and 18 months will be: serum levels of vitamin B12, neuroconduction and cognitive function. Conclusions In view of the high prevalence of vitamin B12 deficiency in later life, the present study has potential public health interest because since it will measure the impact of the existing program of complementary feeding as compared to two options that provide higher vitamin B12 intakes that might potentially may contribute in preserving neurophysiologic and cognitive function and thus improve quality of life for older

  17. Experimental percolation studies of random networks

    Science.gov (United States)

    Feinerman, A.; Weddell, J.

    2017-06-01

    This report establishes an experimental method of studying electrically percolating networks at a higher resolution than previously implemented. This method measures the current across a conductive sheet as a function of time as elliptical pores are cut into the sheet. This is done utilizing a Universal Laser System X2-600 100 W CO2 laser system with a 76 × 46 cm2 field and 394 dpc (dots/cm) resolution. This laser can cut a random system of elliptical pores into a conductive sheet with a potential voltage applied across it and measures the current versus time. This allows for experimental verification of a percolation threshold as a function of the ellipse's aspect ratio (minor/major diameter). We show that as an ellipse's aspect ratio approaches zero, the percolation threshold approaches one. The benefit of this method is that it can experimentally measure the effect of removing small pores, as well as pores with complex geometries, such as an asterisk from a conductive sheet.

  18. Numerical study of microphase separation in gels and random media

    International Nuclear Information System (INIS)

    Uchida, Nariya

    2004-01-01

    Microphase separation in gels and random media is numerically studied using a Ginzburg-Landau model. A random field destroys long-range orientational (lamellar) order and gives rise to a disordered bicontinuous morphology. The dependence of the correlation length on the field strength is distinct from that of random-field magnets

  19. Comparisons of the Pentax-AWS, Glidescope, and Macintosh Laryngoscopes for Intubation Performance during Mechanical Chest Compressions in Left Lateral Tilt: A Randomized Simulation Study of Maternal Cardiopulmonary Resuscitation

    Directory of Open Access Journals (Sweden)

    Sanghyun Lee

    2015-01-01

    Full Text Available Purpose. Rapid advanced airway management is important in maternal cardiopulmonary resuscitation (CPR. This study aimed to compare intubation performances among Pentax-AWS (AWS, Glidescope (GVL, and Macintosh laryngoscope (MCL during mechanical chest compression in 15° and 30° left lateral tilt. Methods. In 19 emergency physicians, a prospective randomized crossover study was conducted to examine the three laryngoscopes. Primary outcomes were the intubation time and the success rate for intubation. Results. The median intubation time using AWS was shorter than that of GVL and MCL in both tilt degrees. The time to visualize the glottic view in GVL and AWS was significantly lower than that of MCL (all P<0.05, whereas there was no significant difference between the two video laryngoscopes (in 15° tilt, P=1; in 30° tilt, P=0.71. The progression of tracheal tube using AWS was faster than that of MCL and GVL in both degrees (all P<0.001. Intubations using AWS and GVL showed higher success rate than that of Macintosh laryngoscopes. Conclusions. The AWS could be an appropriate laryngoscope for airway management of pregnant women in tilt CPR considering intubation time and success rate.

  20. Comparison of liraglutide plus basal insulin and basal-bolus insulin therapy (BBIT) for glycemic control, body weight stability, and treatment satisfaction in patients treated using BBIT for type 2 diabetes without severe insulin deficiency: A randomized prospective pilot study.

    Science.gov (United States)

    Yamamoto, Saki; Hayashi, Toshiyuki; Ohara, Makoto; Goto, Satoshi; Sato, Jun; Nagaike, Hiroe; Fukase, Ayako; Sato, Nobuko; Hiromura, Munenori; Tomoyasu, Masako; Nakanishi, Noriko; Lee, Soushou; Osamura, Anna; Yamamoto, Takeshi; Fukui, Tomoyasu; Hirano, Tsutomu

    2018-03-26

    We examined whether 0.9 mg/day liraglutide plus basal insulin (Lira-basal) is superior to basal-bolus insulin therapy (BBIT) for type 2 diabetes (T2DM) without severe insulin deficiency as determined by glucagon stimulation. Fifty patients receiving BBIT were enrolled in this 24-week, prospective, randomized, open-labeled study. After excluding subjects with fasting C-peptide immunoreactivity (CPR) basal (n = 12) or continued BBIT (n = 13). Primary endpoint was change in HbA1c. Secondary endpoints were changes in body weight (BW), 7-point self-monitored blood glucose (SMBG), and Diabetes Treatment Satisfaction Questionnaire status (DTSQs) scores. The Lira-basal group demonstrated reduced HbA1c, whereas the BBIT group showed no change. BW was reduced in the Lira-basal group but increased in the BBIT group. The Lira-basal group also exhibited significantly reduced pre-breakfast and pre-lunch SMBG. DTSQs scores improved in the Lira-basal group but not the BBIT group. Plasma lipids, liver function, and kidney function were not significantly changed in either group. Lira-basal therapy is superior to BBIT for T2DM without severe insulin deficiency. This study was registered with UMIN Clinical Trials Registry (UMIN000028313). Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.

  1. Comparison of ultrasound-guided posterior transversus abdominis plane block and lateral transversus abdominis plane block for postoperative pain management in patients undergoing cesarean section: a randomized double-blind clinical trial study.

    Science.gov (United States)

    Faiz, Seyed Hamid Reza; Alebouyeh, Mahmoud Reza; Derakhshan, Pooya; Imani, Farnad; Rahimzadeh, Poupak; Ghaderi Ashtiani, Maryam

    2018-01-01

    Due to the importance of pain control after abdominal surgery, several methods such as transversus abdominis plane (TAP) block are used to reduce the pain after surgery. TAP blocks can be performed using various ultrasound-guided approaches. Two important approaches to do this are ultrasound-guided lateral and posterior approaches. This study aimed to compare the two approaches of ultrasound-guided lateral and posterior TAP blocks to control pain after cesarean section. In this double-blind clinical trial study, 76 patients scheduled for elective cesarean section were selected and randomly divided into two groups of 38 and underwent spinal anesthesia. For pain management after the surgery, one group underwent lateral TAP block and the other group underwent posterior TAP block using 20cc of ropivacaine 0.2% on both sides. Pain intensity was evaluated based on Numerical Analog Scale (NAS) at rest and when coughing, 2, 4, 6, 12, 24 and 36 hours after surgery. The pain at rest in the posterior group at all hours post surgery was lower than the lateral group, especially at 6, 12 and 24 hours after the surgery and the difference was statistically significant ( p =0.03, p block compared with the lateral TAP block was more effective in pain control after cesarean section.

  2. [Randomized parallel group study of 0.0015% tafluprost ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension (comparison with 0.005% latanoprost ophthalmic solution)].

    Science.gov (United States)

    Ge, Jian; Li, Xiaoxin; Sun, Xinghuai; He, Xiangge; Zhang, Hong

    2015-02-01

    To confirm the non-inferiority of the IOP-lowering effect of the 0.0015% Tafluprost ophthalmic solution to the 0.005% Latanoprost ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension.Safety was also compared between two groups. This study was conducted from August 2008 to December 2009, at five clinical trial sites in China. Patients of this study population was diagnosed with primary open-angle glaucoma or ocular hypertension in both eyes.Subjects were randomized into 0.0015% Tafluprost group or 0.005% Latanoprost group.Intraocular pressure (IOP) measurement by Goldmann applanation tonometer, slit-lamp microscopy, Gonioscopy, Fundascopy, Visual acuity test, Perimetry, Blood pressure and pulse rate, Subjective symptoms were compered between two groups at Week 0, Week 2 and Week 4.For main effectiveness evaluation index adopt the bad effect evaluation, safety evaluation index by Fisher's exact test probability method. The 246 subjects/246 eyes were randomized (Tafluprost group:122 subjects/122 eyes, Latanoprost group:124 subjects/ 124 eyes). Change in the IOP at 17:00 of Week 2 is (8.8 ± 3.8) mmHg and (8.9 ± 4.4) mmHg (1 mmHg = 0.133 kPa) in Tafluprost group and Latanoprost group. Percent change in the IOP at 17:00 of Week 2 is (33.2 ± 12.8)% and (34.4 ± 14.1)% in Tafluprost group and Latanoprost group. Change in the IOP at 17:00 at the end of treatment is (9.8 ± 4.0) mmHg and (9.2 ± 4.1) mmHg in Tafluprost group and Latanoprost group. Percent change in the IOP at 17:00 at the end of treatment is 37.2% ± 13.4% group and 35.7% ± 13.0% in Tafluprost and Latanoprost group.In addition, distribution of subjects with percentage decrease of IOP > 30% was 72.5% in Tafluprost group higher than 63.8% in Latanoprost group. The major adverse reactions were conjunctival hyperemia, eye irritation, eye pain and foreign body sensation. The incidence of adverse reactions is 31.7% in Tafluprost group and 20.8% in Latanoprost group. The inter

  3. Comparison of randomization techniques for clinical trials with data from the HOMERUS-trial

    NARCIS (Netherlands)

    Verberk, W. J.; Kroon, A. A.; Kessels, A. G. H.; Nelemans, P. J.; van Ree, J. W.; Lenders, J. W. M.; Thien, T.; Bakx, J. C.; van Montfrans, G. A.; Smit, A. J.; Beltman, F. W.; de Leeuw, P. W.

    2005-01-01

    Background. Several methods of randomization are available to create comparable intervention groups in a study. In the HOMERUS-trial, we compared the minimization procedure with a stratified and a non-stratified method of randomization in order to test which one is most appropriate for use in

  4. Comparison of randomization techniques for clinical trials with data from the HOMERUS-trial.

    NARCIS (Netherlands)

    Verberk, W.J.; Kroon, A.A.; Kessels, A.G.H.; Nelemans, P.J.; Ree, J.W. van; Lenders, J.W.M.; Thien, Th.; Bakx, J.C.; Montfrans, G.A. van; Smit, A.J.; Beltman, F.W.; Leeuw, P.W. de

    2005-01-01

    BACKGROUND: Several methods of randomization are available to create comparable intervention groups in a study. In the HOMERUS-trial, we compared the minimization procedure with a stratified and a non-stratified method of randomization in order to test which one is most appropriate for use in

  5. A Comparison between Decision Tree and Random Forest in Determining the Risk Factors Associated with Type 2 Diabetes.

    Science.gov (United States)

    Esmaily, Habibollah; Tayefi, Maryam; Doosti, Hassan; Ghayour-Mobarhan, Majid; Nezami, Hossein; Amirabadizadeh, Alireza

    2018-04-24

    We aimed to identify the associated risk factors of type 2 diabetes mellitus (T2DM) using data mining approach, decision tree and random forest techniques using the Mashhad Stroke and Heart Atherosclerotic Disorders (MASHAD) Study program. A cross-sectional study. The MASHAD study started in 2010 and will continue until 2020. Two data mining tools, namely decision trees, and random forests, are used for predicting T2DM when some other characteristics are observed on 9528 subjects recruited from MASHAD database. This paper makes a comparison between these two models in terms of accuracy, sensitivity, specificity and the area under ROC curve. The prevalence rate of T2DM was 14% among these subjects. The decision tree model has 64.9% accuracy, 64.5% sensitivity, 66.8% specificity, and area under the ROC curve measuring 68.6%, while the random forest model has 71.1% accuracy, 71.3% sensitivity, 69.9% specificity, and area under the ROC curve measuring 77.3% respectively. The random forest model, when used with demographic, clinical, and anthropometric and biochemical measurements, can provide a simple tool to identify associated risk factors for type 2 diabetes. Such identification can substantially use for managing the health policy to reduce the number of subjects with T2DM .

  6. Comparison of the effects of oxycodone versus fentanyl on airway reflex to tracheal extubation and postoperative pain during anesthesia recovery after laparoscopic cholecystectomy: A double-blind, randomized clinical consort study.

    Science.gov (United States)

    Choi, Eun Kyung; Kwon, Nyeongkeon; Park, Sang-Jin

    2018-03-01

    Fentanyl has been suggested to be effective for controlling airway and hemodynamic responses to tracheal extubation. This study was performed to compare the effects of oxycodone and fentanyl on airway and hemodynamic responses and postoperative pain during the recovery period in patients undergoing laparoscopic cholecystectomy. Ninety patients aged 18 to 65 years were randomly allocated to 1 of 3 groups: fentanyl, oxycodone, and control. Coughing responses (incidence and severity), hemodynamic responses during the recovery period, and acute postoperative pain were assessed. The incidence of cough was decreased in the fentanyl and oxycodone groups compared with that in the control group at the points of awareness and extubation, and no significant difference was observed between the 2 treatment groups. Severe cough response was decreased in the fentanyl and oxycodone groups compared with that in the control group at the point of extubation, and no significant change was observed in cough severity between the 2 treatment groups. Postoperative pain scores were lower in the fentanyl and oxycodone groups than those in the control group at 5 and 30 minutes postoperatively, and no significant difference was observed between the 2 treatment groups. Hemodynamic responses did not differ among the 3 groups during the recovery period. Oxycodone treatment before tracheal extubation reduced cough response and was as effective as fentanyl treatment for improving extubation quality. Furthermore, single boluses of fentanyl and oxycodone showed equal effectiveness in attenuating acute postoperative pain in patients undergoing laparoscopic cholecystectomy.

  7. Comparison of gut-directed hypnotherapy and unspecific hypnotherapy as self-help format in children and adolescents with functional abdominal pain or irritable bowel syndrome: a randomized pilot study.

    Science.gov (United States)

    Gulewitsch, Marco D; Schlarb, Angelika A

    2017-12-01

    Psychosocial treatments for chronic abdominal pain in childhood or adolescence are effective, but time consuming and hardly available. In the present study, gut-directed hypnotherapy (GDHT) and unspecific hypnotherapy (UHT) were compared to evaluate the feasibility and efficacy of a hypnotherapeutic self-help intervention. Children/adolescents between 6 and 17 years of age with chronic abdominal pain were randomized to GDHT or UHT. The treatment period was 12 weeks each. Measurements were performed before and after treatment. The primary outcome was a pain diary. Analysis was carried out as per protocol. Of 45 participants included, 13 were lost to follow-up. Thirty-two participants (14 GHDT, 18 UHT) were analyzed. Dropouts had higher pain severity. Completers in both conditions showed good adherence and a similar decrease in days with pain and pain duration. Pain intensity decreased only in the UHT condition. Eleven participants (two GDHT, nine UHT) achieved clinical remission (>80% improvement) and 13 participants (seven GDHT, six UHT) improved significantly (30-80%). Results suggest a high efficacy of standardized home-based hypnotherapy for children/adolescents with abdominal pain. Children/adolescents with high pain severity are at risk of dropping out. The UHT condition showed slight evidence of superiority, but conditions were equivalent on most outcomes. Taken together, self-help approaches based on hypnotherapy could close a treatment gap and prevent chronification.

  8. Comparison of intra-articular injections of Hyaluronic Acid and Corticosteroid in the treatment of Osteoarthritis of the hip in comparison with intra-articular injections of Bupivacaine. Design of a prospective, randomized, controlled study with blinding of the patients and outcome assessors

    NARCIS (Netherlands)

    Colen, S.; van den Bekerom, M.P.J.; Bellemans, J.; Mulier, M.

    2010-01-01

    Background: Although intra-articular hyaluronic acid is well established as a treatment for osteoarthritis of the knee, its use in hip osteoarthritis is not based on large randomized controlled trials. There is a need for more rigorously designed studies on hip osteoarthritis treatment as this

  9. Comparison of intra-articular injections of hyaluronic acid and corticosteroid in the treatment of osteoarthritis of the hip in comparison with intra-articular injections of bupivacaine. Design of a prospective, randomized, controlled study with blinding of the patients and outcome assessors

    NARCIS (Netherlands)

    Colen, Sascha; van den Bekerom, Michel P. J.; Bellemans, Johan; Mulier, Michiel

    2010-01-01

    Although intra-articular hyaluronic acid is well established as a treatment for osteoarthritis of the knee, its use in hip osteoarthritis is not based on large randomized controlled trials. There is a need for more rigorously designed studies on hip osteoarthritis treatment as this subject is still

  10. Benefits of preparing for childbirth with mindfulness training: a randomized controlled trial with active comparison.

    Science.gov (United States)

    Duncan, Larissa G; Cohn, Michael A; Chao, Maria T; Cook, Joseph G; Riccobono, Jane; Bardacke, Nancy

    2017-05-12

    Childbirth fear is linked with lower labor pain tolerance and worse postpartum adjustment. Empirically validated childbirth preparation options are lacking for pregnant women facing this problem. Mindfulness approaches, now widely disseminated, can alleviate symptoms of both chronic and acute pain and improve psychological adjustment, suggesting potential benefit when applied to childbirth education. This study, the Prenatal Education About Reducing Labor Stress (PEARLS) study, is a randomized controlled trial (RCT; n = 30) of a short, time-intensive, 2.5-day mindfulness-based childbirth preparation course offered as a weekend workshop, the Mind in Labor (MIL): Working with Pain in Childbirth, based on Mindfulness-Based Childbirth and Parenting (MBCP) education. First-time mothers in the late 3rd trimester of pregnancy were randomized to attend either the MIL course or a standard childbirth preparation course with no mind-body focus. Participants completed self-report assessments pre-intervention, post-intervention, and post-birth, and medical record data were collected. In a demographically diverse sample, this small RCT demonstrated mindfulness-based childbirth education improved women's childbirth-related appraisals and psychological functioning in comparison to standard childbirth education. MIL program participants showed greater childbirth self-efficacy and mindful body awareness (but no changes in dispositional mindfulness), lower post-course depression symptoms that were maintained through postpartum follow-up, and a trend toward a lower rate of opioid analgesia use in labor. They did not, however, retrospectively report lower perceived labor pain or use epidural less frequently than controls. This study suggests mindfulness training carefully tailored to address fear and pain of childbirth may lead to important maternal mental health benefits, including improvements in childbirth-related appraisals and the prevention of postpartum

  11. A comparison between diuretics and angiotensin-receptor blocker agents in patients with stage I hypertension (PREVER-treatment trial: study protocol for a randomized double-blind controlled trial

    Directory of Open Access Journals (Sweden)

    Figueiredo Neto José A

    2011-02-01

    Full Text Available Abstract Background Cardiovascular disease is the leading cause of death in Brazil, and hypertension is its major risk factor. The benefit of its drug treatment to prevent major cardiovascular events was consistently demonstrated. Angiotensin-receptor blockers (ARB have been the preferential drugs in the management of hypertension worldwide, despite the absence of any consistent evidence of advantage over older agents, and the concern that they may be associated with lower renal protection and risk for cancer. Diuretics are as efficacious as other agents, are well tolerated, have longer duration of action and low cost, but have been scarcely compared with ARBs. A study comparing diuretic and ARB is therefore warranted. Methods/design This is a randomized, double-blind, clinical trial, comparing the association of chlorthalidone and amiloride with losartan as first drug option in patients aged 30 to 70 years, with stage I hypertension. The primary outcomes will be variation of blood pressure by time, adverse events and development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG. The secondary outcomes will be fatal or non-fatal cardiovascular events: myocardial infarction, stroke, heart failure, evidence of new subclinical atherosclerosis and sudden death. The study will last 18 months. The sample size will be of 1200 participants for group in order to confer enough power to test for all primary outcomes. The project was approved by the Ethics committee of each participating institution. Discussion The putative pleiotropic effects of ARB agents, particularly renal protection, have been disputed, and they have been scarcely compared with diuretics in large clinical trials, despite that they have been at least as efficacious as newer agents in managing hypertension. Even if the null hypothesis is not rejected, the information will be useful for health care policy to treat hypertension in Brazil. Clinical trials

  12. A randomized study of the immunogenicity and safety of Japanese encephalitis chimeric virus vaccine (JE-CV) in comparison with SA14-14-2 vaccine in children in the Republic of Korea.

    Science.gov (United States)

    Kim, Dong Soo; Houillon, Guy; Jang, Gwang Cheon; Cha, Sung-Ho; Choi, Soo-Han; Lee, Jin; Kim, Hwang Min; Kim, Ji Hong; Kang, Jin Han; Kim, Jong-Hyun; Kim, Ki Hwan; Kim, Hee Soo; Bang, Joon; Naimi, Zulaikha; Bosch-Castells, Valérie; Boaz, Mark; Bouckenooghe, Alain

    2014-01-01

    A new live attenuated Japanese encephalitis chimeric virus vaccine (JE-CV) has been developed based on innovative technology to give protection against JE with an improved immunogenicity and safety profile. In this phase 3, observer-blind study, 274 children aged 12-24 months were randomized 1:1 to receive one dose of JE-CV (Group JE-CV) or the SA14-14-2 vaccine currently used to vaccinate against JE in the Republic of Korea (Group SA14-14-2). JE neutralizing antibody titers were assessed using PRNT50 before and 28 days after vaccination. The primary endpoint of non-inferiority of seroconversion rates on D28 was demonstrated in the Per Protocol analysis set as the difference between Group JE-CV and Group SA14-14-2 was 0.9 percentage points (95% confidence interval [CI]: -2.35; 4.68), which was above the required -10%. Seroconversion and seroprotection rates 28 days after administration of a single vaccine dose were 100% in Group JE-CV and 99.1% in Group SA14-14-2; all children except one (Group SA14-14-2) were seroprotected. Geometric mean titers (GMTs) increased in both groups from D0 to D28; GM of titer ratios were slightly higher in Group JE-CV (182 [95% CI: 131; 251]) than Group SA14-14-2 (116 [95% CI: 85.5, 157]). A single dose of JE-CV was well tolerated and no safety concerns were identified. In conclusion, a single dose of JE-CV or SA14-14-2 vaccine elicited a comparable immune response with a good safety profile. Results obtained in healthy Korean children aged 12-24 months vaccinated with JE-CV are consistent with those obtained in previous studies conducted with JE-CV in toddlers.

  13. Comparison of the efficacy of Neethling lumpy skin disease virus and x10RM65 sheep-pox live attenuated vaccines for the prevention of lumpy skin disease - The results of a randomized controlled field study.

    Science.gov (United States)

    Ben-Gera, J; Klement, E; Khinich, E; Stram, Y; Shpigel, N Y

    2015-09-11

    Lumpy skin disease (LSD) is a viral disease of cattle and buffalo, caused by a Capripox virus. A field study was performed during an LSD epidemic which occurred in 2012-2013 in Israel, in order to assess the efficacy of two commercial vaccines for protection against LSD. Fifteen dairy herds, vaccinated 2-5 months prior to study onset with a single dose of 10(2.5) TCID50 of RM65 attenuated sheep-pox vaccine, and not affected previously, were enrolled in the study. 4694 cows were randomized to be either vaccinated with a 10(3.5) TCID50/dose of RM65 vaccine (x10RM65) or with a same dose of an attenuated Neethling LSD virus vaccine. A case of LSD was defined as the appearance of at least 5 lesions typical to LSD and a severe case was defined if this sign was accompanied by either fever (>39.5°C) or/and a 20% reduction in milk production. Deep lesion biopsies and blood samples were collected from 64.5% of the cases in an attempt to detect DNA of LSD virus by PCR and to differentiate between the wild strain and the vaccine Neethling strain. Seventy-six cows were affected by LSD in 8 herds with an incidence of 0.3-5.7%. Mantel-Haenszel relative risk (RRMH) for LSD morbidity at least 15 days after vaccination in x10RM65 vs. Neethling was 2.635 (CI95%=1.44-4.82) and 11.2 (2.3-54.7) for severe morbidity. RRMH for laboratory confirmed cases was 4.28 (1.59-11.53). An incidence of 0.38% (9/2356) of Neethling associated disease was observed among Neethling vaccinated cows while no such disease occurred in x10RM65 vaccinated cows. We conclude that the Neethling vaccine is significantly more effective than x10RM65 in preventing LSD morbidity, though it might cause a low incidence of Neethling associated disease. No transmission of the Neethling strain to non-Neethling vaccinated cows was observed in this study. Copyright © 2015 Elsevier Ltd. All rights reserved.

  14. Pharmacokinetic comparison of controlled-release and immediate-release oral formulations of simvastatin in healthy Korean subjects: a randomized, open-label, parallel-group, single- and multiple-dose study.

    Science.gov (United States)

    Jang, Seong Bok; Lee, Yoon Jung; Lim, Lay Ahyoung; Park, Kyung-Mi; Kwon, Bong-Ju; Woo, Jong Soo; Kim, Yong-Il; Park, Min Soo; Kim, Kyung Hwan; Park, Kyungsoo

    2010-01-01

    A controlled-release (CR) formulation of simvastatin was recently developed in Korea. The formulation is expected to yield a lower C(max) and similar AUC values compared with the immediate-release (IR) formulation. The goal of this study was to compare the pharmacokinetics of the new CR formulation and an IR formulation of simvastatin after single- and multiple-dose administration in healthy Korean subjects. This study was developed as part of a product development project at the request of the Korean regulatory agency. This was a randomized, open-label, parallelgroup, 2-part study. Eligible subjects were healthy male or female volunteers between the ages of 19 and 55 years and within 20% of their ideal weight. In part I, each subject received a single dose of the CR or IR formulation of simvastatin 40 mg orally (20 mg x 2 tablets) after fasting. In part II, each subject received the same dose of the CR or IR formulation for 8 consecutive days. Blood samples were obtained for 48 hours after the dose in part I and after the first and the last dose in part II. Pharmacokinetic parameters were determined for both simvastatin (the inactive prodrug) and simvastatin acid (the active moiety). An adverse event (AE) was defined as any unfavorable sign (including an abnormal laboratory finding) or symptom, regardless of whether it had a causal relationship with the study medication. Serious AEs were defined as any events that are considered life threatening, require hospitalization or prolongation of existing hospitalization, cause persistent or significant disability or incapacity, or result in congenital abnormality, birth defect, or death. AEs were determined based on patient interviews and physical examinations. Twenty-four healthy subjects (17 men, 7 women; mean [SD] age, 29 [7] years; age range, 22-50 years) were enrolled in part I, and 29 subjects (17 men, 12 women; mean age, 33 [9] years; age range, 19-55 years) were enrolled in part II. For simvastatin acid, C

  15. Continuous spinal analgesia with levobupivacaine for postoperative pain management: Comparison of 0.125% versus 0.0625% in elective total knee and hip replacement: A double-blind randomized study

    Directory of Open Access Journals (Sweden)

    Alessandro D′Ambrosio

    2015-01-01

    Full Text Available Background and Aims: Continuous spinal anesthesia (CSA has not been widely used for postoperative analgesia, mainly to avoid complications from the subarachnoid injection. Recently, the introduction of low caliber CSA catheters (Spinocath ® , has allowed to decrease anesthetics doses and volumes with good analgesia and reduced complications. The aim of this present study was to compare two concentrations of levobupivacaine administered through CSA for postoperative pain management after major orthopedic surgery. Secondary outcomes were adverse events associated with CSA. Material and Methods: Thirty-two patients were randomized to receive sufentanil 1 mcg/h plus levobupivacaine 0.125%-1 ml/h (Group A 0.125 or 0.0625%-2 ml/h (Group B 0.0625 for postoperative analgesia through CSA catheter, connected to the elastomeric pump over 48 h. The quality of analgesia was assessed based on pain intensity by Visual Analogic Scale (VAS. Sensory and motor function, hemodynamic, and respiratory parameters were recorded for 96 h after surgery, after which the catheter was removed. In addition, joint mobility was assessed, and any side effects were noted. Results: VAS score was ≤30 mm in 25 patients. Three patients in Group A 0.125 and 4 in Group B 0.0625 (NS, received a rescue dose of levobupivacaine. Median VAS in Group A 0.125 was lower than in Group B 0.0625 on T 1 h (8 ± 11 vs 16 ± 11; P < 0.05, and on T 4 h (11 ± 8 vs 18 ± 1; P < 0.05. All patients remained hemodynamically stable. There were no significant differences between groups for postoperative joints mobility. Conclusion: Levobupivacaine at a dose of 1.25 mg/h administered by CSA provides good quality analgesia independent of concentration and solution volume in patients undergoing total knee and hip replacement.

  16. Comparison of patient-controlled intravenous analgesia with sufentanil versus tramadol in post-cesarean section pain management and lactation after general anesthesia - a prospective, randomized, double-blind, controlled study.

    Science.gov (United States)

    Chi, Xiaohui; Li, Man; Mei, Wei; Liao, Mingfeng

    2017-01-01

    Acute pain is a common complication following cesarean section under general anesthesia. Post-cesarean section pain management is important for both the mother and the newborn. This study compared the effects of patient-controlled intravenous analgesia (PCIA) using sufentanil or tramadol on postoperative pain control and initiation time of lactation in patients who underwent cesarean section under general anesthesia. Primiparas (n=146) scheduled for cesarean section under general anesthesia were randomized to receive PCIA with sufentanil or tramadol. Movement-evoked and rest-pain intensity were assessed by the Numerical Rating Scale (NRS) postoperatively. The number of PCIA attempts, amount of drug consumed, initiation time of lactation, and Quality of Recovery Score 40 (QoR-40) were recorded at 4, 8, 12, and 24 h postoperatively. Pre- and postoperative serum prolactin levels were recorded. No between-group difference existed in the NRS at rest at any time point postoperatively. Patients on sufentanil had more movement-evoked pain and a higher sedation score at 4, 8, and 12 h postoperatively, as compared with the tramadol group. At 24 h, the QoR-40 was higher in the tramadol group compared with the sufentanil group. No significant between-group differences were present in patient satisfaction and nausea/vomiting scores. Postpartum prolactin levels were significantly higher in the tramadol group versus the sufentanil group, corresponding with a significant delay in initiation of lactation in the latter. PCIA with tramadol may be preferred due to lower movement-evoked pain, higher quality of recovery, and earlier lactation in patients following cesarean section under general anesthesia.

  17. Flood damage estimation of companies: A comparison of Stage-Damage-Functions and Random Forests

    Science.gov (United States)

    Sieg, Tobias; Kreibich, Heidi; Vogel, Kristin; Merz, Bruno

    2017-04-01

    The development of appropriate flood damage models plays an important role not only for the damage assessment after an event but also to develop adaptation and risk mitigation strategies. So called Stage-Damage-Functions (SDFs) are often applied as a standard approach to estimate flood damage. These functions assign a certain damage to the water depth depending on the use or other characteristics of the exposed objects. Recent studies apply machine learning algorithms like Random Forests (RFs) to model flood damage. These algorithms usually consider more influencing variables and promise to depict a more detailed insight into the damage processes. In addition they provide an inherent validation scheme. Our study focuses on direct, tangible damage of single companies. The objective is to model and validate the flood damage suffered by single companies with SDFs and RFs. The data sets used are taken from two surveys conducted after the floods in the Elbe and Danube catchments in the years 2002 and 2013 in Germany. Damage to buildings (n = 430), equipment (n = 651) as well as goods and stock (n = 530) are taken into account. The model outputs are validated via a comparison with the actual flood damage acquired by the surveys and subsequently compared with each other. This study investigates the gain in model performance with the use of additional data and the advantages and disadvantages of the RFs compared to SDFs. RFs show an increase in model performance with an increasing amount of data records over a comparatively large range, while the model performance of the SDFs is already saturated for a small set of records. In addition, the RFs are able to identify damage influencing variables, which improves the understanding of damage processes. Hence, RFs can slightly improve flood damage predictions and provide additional insight into the underlying mechanisms compared to SDFs.

  18. A comprehensive comparison of random forests and support vector machines for microarray-based cancer classification

    Directory of Open Access Journals (Sweden)

    Wang Lily

    2008-07-01

    Full Text Available Abstract Background Cancer diagnosis and clinical outcome prediction are among the most important emerging applications of gene expression microarray technology with several molecular signatures on their way toward clinical deployment. Use of the most accurate classification algorithms available for microarray gene expression data is a critical ingredient in order to develop the best possible molecular signatures for patient care. As suggested by a large body of literature to date, support vector machines can be considered "best of class" algorithms for classification of such data. Recent work, however, suggests that random forest classifiers may outperform support vector machines in this domain. Results In the present paper we identify methodological biases of prior work comparing random forests and support vector machines and conduct a new rigorous evaluation of the two algorithms that corrects these limitations. Our experiments use 22 diagnostic and prognostic datasets and show that support vector machines outperform random forests, often by a large margin. Our data also underlines the importance of sound research design in benchmarking and comparison of bioinformatics algorithms. Conclusion We found that both on average and in the majority of microarray datasets, random forests are outperformed by support vector machines both in the settings when no gene selection is performed and when several popular gene selection methods are used.

  19. Estimators of the Relations of Equivalence, Tolerance and Preference Based on Pairwise Comparisons with Random Errors

    Directory of Open Access Journals (Sweden)

    Leszek Klukowski

    2012-01-01

    Full Text Available This paper presents a review of results of the author in the area of estimation of the relations of equivalence, tolerance and preference within a finite set based on multiple, independent (in a stochastic way pairwise comparisons with random errors, in binary and multivalent forms. These estimators require weaker assumptions than those used in the literature on the subject. Estimates of the relations are obtained based on solutions to problems from discrete optimization. They allow application of both types of comparisons - binary and multivalent (this fact relates to the tolerance and preference relations. The estimates can be verified in a statistical way; in particular, it is possible to verify the type of the relation. The estimates have been applied by the author to problems regarding forecasting, financial engineering and bio-cybernetics. (original abstract

  20. Pharmacokinetic comparison of sustained- and immediate-release oral formulations of cilostazol in healthy Korean subjects: a randomized, open-label, 3-part, sequential, 2-period, crossover, single-dose, food-effect, and multiple-dose study.

    Science.gov (United States)

    Lee, Donghwan; Lim, Lay Ahyoung; Jang, Seong Bok; Lee, Yoon Jung; Chung, Jae Yong; Choi, Jong Rak; Kim, Kiyoon; Park, Jin Woo; Yoon, Hosang; Lee, Jaeyong; Park, Min Soo; Park, Kyungsoo

    2011-12-01

    A sustained-release (SR) formulation of cilostazol was recently developed in Korea and was expected to yield a lower C(max) and a similar AUC to the immediate-release (IR) formulation. The goal of the present study was to compare the pharmacokinetic profiles of a newly developed SR formulation and an IR formulation of cilostazol after single- and multiple-dose administration and to evaluate the influence of food in healthy Korean subjects. This study was developed as part of a product development project at the request of the Korean regulatory agency. This was a randomized, 3-part, sequential, open-label, 2-period crossover study. Each part consisted of different subjects between the ages of 19 and 55 years. In part 1, each subject received a single dose of SR (200 mg × 1 tablet, once daily) and IR (100 mg × 2 tablets, BID) formulations of cilostazol orally 7 days apart in a fasted state. In part 2, each subject received a single dose of the SR (200 mg × 1 tablet, once daily) formulation of cilostazol 7 days apart in a fasted and a fed state. In part 3, each subject received multiple doses of the 2 formulations for 8 consecutive days 21 days apart. Blood samples were taken for 72 hours after the dose. Cilostazol pharmacokinetics were determined for both the parent drug and its metabolites (OPC-13015 and OPC-13213). Adverse events were evaluated through interviews and physical examinations. Among the 92 enrolled subjects (66 men, 26 women; part 1, n = 26; part 2, n = 26; part 3, n = 40), 87 completed the study. In part 1, all the primary pharmacokinetic parameters satisfied the criterion for assumed bioequivalence both in cilostazol and its metabolites, yielding 90% CI ratios of 0.9624 to 1.2323, 0.8873 to 1.1208, and 0.8919 to 1.1283 for C(max) and 0.8370 to 1.0134, 0.8204 to 0.9807, and 0.8134 to 0.9699 for AUC(0-last) of cilostazol, OPC-13015, and OPC-13213, respectively. In part 2, food intake increased C(max) and AUC significantly (P food and 23 with a high

  1. Post-operative analgesia following total knee arthroplasty: comparison of low-dose intrathecal morphine and single-shot ultrasound-guided femoral nerve block: a randomized, single blinded, controlled study.

    Science.gov (United States)

    Frassanito, L; Vergari, A; Zanghi, F; Messina, A; Bitondo, M; Antonelli, M

    2010-07-01

    Total knee arthroplasty often results in marked postoperative pain. A recent meta-analysis supports the use of femoral nerve block or alternatively spinal injection of morphine plus local anaesthetic for post-operative analgesia. On the other hand, the use of intrathecal morphine may be associated with a large number of distressing side effects (itching, urinary retention, nausea and vomiting, delayed respiratory depression). The aim of this study was to compare the effectiveness of femoral nerve block and low dose intrathecal morphine in post-operative analgesia after primary unilateral total knee arthroplasty. Fifty-two consecutive patients scheduled for primary unilateral total knee arthroplasty were allocated to the intrathecal morphine group (ITM group) or to the femoral nerve block group (FNB group). In ITM group a subarachnoid puncture was performed at the L3-L4 inter-vertebral space with hyperbaric bupivacaine 15 mg plus 100 mcg of preservative-free morphine. Patients allocated to the FNB group received a single-injection ultrasound-assisted femoral nerve block with ropivacaine 0.75% 25 ml before the spinal injection of hyperbaric bupivacaine 15 mg. All patients received postoperative patient-controlled-analgesia (PCA) morphine, using a 1-mg bolus and a 5-minute lockout period. Data were analyzed using Student t test or two-way analysis of variance (ANOVA) for repeated measures with time and treatment as the 2 factors. Post hoc comparisons were performed by Bonferroni test. Statistical significance for all test was a p value < 0.05. Patient characteristics were similar between the 2 groups. We found a statistically significant differences in postoperative pain between the two groups: ITM group had the lower visual analogic pain score (VAS) values. Morphine consumption was lower in the ITM group: average consumption within the first 6 hours was 0.9 mg in IT group compared to 3.1 mg in FNB group; at 12 h 4.2 mg vs 6.3 mg; at 24 h 6.9 mg vs 10.3 mg; at 48 h 9

  2. A randomized, crossover, head-to-head comparison of eicosapentaenoic acid and docosahexaenoic acid supplementation to reduce inflammation markers in men and women: the Comparing EPA to DHA (ComparED) Study.

    Science.gov (United States)

    Allaire, Janie; Couture, Patrick; Leclerc, Myriam; Charest, Amélie; Marin, Johanne; Lépine, Marie-Claude; Talbot, Denis; Tchernof, André; Lamarche, Benoît

    2016-08-01

    To date, most studies on the anti-inflammatory effects of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in humans have used a mixture of the 2 fatty acids in various forms and proportions. We compared the effects of EPA supplementation with those of DHA supplementation (re-esterified triacylglycerol; 90% pure) on inflammation markers (primary outcome) and blood lipids (secondary outcome) in men and women at risk of cardiovascular disease. In a double-blind, randomized, crossover, controlled study, healthy men (n = 48) and women (n = 106) with abdominal obesity and low-grade systemic inflammation consumed 3 g/d of the following supplements for periods of 10 wk: 1) EPA (2.7 g/d), 2) DHA (2.7 g/d), and 3) corn oil as a control with each supplementation separated by a 9-wk washout period. Primary analyses assessed the difference in cardiometabolic outcomes between EPA and DHA. Supplementation with DHA compared with supplementation with EPA led to a greater reduction in interleukin-18 (IL-18) (-7.0% ± 2.8% compared with -0.5% ± 3.0%, respectively; P = 0.01) and a greater increase in adiponectin (3.1% ± 1.6% compared with -1.2% ± 1.7%, respectively; P DHA and EPA, changes in CRP (-7.9% ± 5.0% compared with -1.8% ± 6.5%, respectively; P = 0.25), IL-6 (-12.0% ± 7.0% compared with -13.4% ± 7.0%, respectively; P = 0.86), and tumor necrosis factor-α (-14.8% ± 5.1% compared with -7.6% ± 10.2%, respectively; P = 0.63) were NS. DHA compared with EPA led to more pronounced reductions in triglycerides (-13.3% ± 2.3% compared with -11.9% ± 2.2%, respectively; P = 0.005) and the cholesterol:HDL-cholesterol ratio (-2.5% ± 1.3% compared with 0.3% ± 1.1%, respectively; P = 0.006) and greater increases in HDL cholesterol (7.6% ± 1.4% compared with -0.7% ± 1.1%, respectively; P DHA compared with EPA was significant in men but not in women (P-treatment × sex interaction = 0.046). DHA is more effective than EPA in modulating specific markers of inflammation

  3. Evolutionary dynamics of adult stem cells: Comparison of random and immortal strand segregation mechanisms

    OpenAIRE

    Tannenbaum, Emmanuel; Sherley, James L.; Shakhnovich, Eugene I.

    2004-01-01

    This paper develops a point-mutation model describing the evolutionary dynamics of a population of adult stem cells. Such a model may prove useful for quantitative studies of tissue aging and the emergence of cancer. We consider two modes of chromosome segregation: (1) Random segregation, where the daughter chromosomes of a given parent chromosome segregate randomly into the stem cell and its differentiating sister cell. (2) ``Immortal DNA strand'' co-segregation, for which the stem cell reta...

  4. A randomized multicenter comparison of hybrid sirolimus-eluting stents with bioresorbable polymer versus everolimus-eluting stents with durable polymer in total coronary occlusion: rationale and design of the Primary Stenting of Occluded Native Coronary Arteries IV study

    Directory of Open Access Journals (Sweden)

    Teeuwen Koen

    2012-12-01

    Full Text Available Abstract Background Percutaneous recanalization of total coronary occlusion (TCO was historically hampered by high rates of restenosis and reocclusions. The PRISON II trial demonstrated a significant restenosis reduction in patients treated with sirolimus-eluting stents compared with bare metal stents for TCO. Similar reductions in restenosis were observed with the second-generation zotarolimus-eluting stent and everolimus-eluting stent. Despite favorable anti-restenotic efficacy, safety concerns evolved after identifying an increased rate of very late stent thrombosis (VLST with drug-eluting stents (DES for the treatment of TCO. Late malapposition caused by hypersensitivity reactions and chronic inflammation was suggested as a probable cause of these VLST. New DES with bioresorbable polymer coatings were developed to address these safety concerns. No randomized trials have evaluated the efficacy and safety of the new-generation DES with bioresorbable polymers in patients treated for TCO. Methods/Design The prospective, randomized, single-blinded, multicenter, non-inferiority PRISON IV trial was designed to evaluate the safety, efficacy, and angiographic outcome of hybrid sirolimus-eluting stents with bioresorbable polymers (Orsiro; Biotronik, Berlin, Germany compared with everolimus-eluting stents with durable polymers (Xience Prime/Xpedition; Abbott Vascular, Santa Clara, CA, USA in patients with successfully recanalized TCOs. In total, 330 patients have been randomly allocated to each treatment arm. Patients are eligible with estimated duration of TCO ≥4 weeks with evidence of ischemia in the supply area of the TCO. The primary endpoint is in-segment late luminal loss at 9-month follow-up angiography. Secondary angiographic endpoints include in-stent late luminal loss, minimal luminal diameter, percentage of diameter stenosis, in-stent and in-segment binary restenosis and reocclusions at 9-month follow-up. Additionally, optical coherence

  5. Trimethoprim-sulfamethoxazole in children with chronic otitis media: a randomized comparison of costs and effects.

    NARCIS (Netherlands)

    Boonacker, C.W.; Veen, E.L. van der; Wilt, G.J. van der; Schilder, A.G.M.; Rovers, M.M.

    2008-01-01

    OBJECTIVE: To study the cost-effectiveness of a 6- to 12-week course of high-dose oral trimethoprim-sulfamethoxazole in children with chronic active otitis media (COM). STUDY DESIGN: Cost-effectiveness study including both direct and indirect costs alongside a randomized placebo-controlled trial.

  6. Microbiota-based Signature of Gingivitis Treatments: A Randomized Study.

    Science.gov (United States)

    Huang, Shi; Li, Zhen; He, Tao; Bo, Cunpei; Chang, Jinlan; Li, Lin; He, Yanyan; Liu, Jiquan; Charbonneau, Duane; Li, Rui; Xu, Jian

    2016-04-20

    Plaque-induced gingivitis can be alleviated by various treatment regimens. To probe the impacts of various anti-gingivitis treatments on plaque microflora, here a double blinded, randomized controlled trial of 91 adults with moderate gingivitis was designed with two anti-gingivitis regimens: the brush-alone treatment and the brush-plus-rinse treatment. In the later group, more reduction in both Plaque Index (TMQHI) and Gingival Index (mean MGI) at Day 3, Day 11 and Day 27 was evident, and more dramatic changes were found between baseline and other time points for both supragingival plaque microbiota structure and salivary metabonomic profiles. A comparison of plaque microbiota changes was also performed between these two treatments and a third dataset where 50 subjects received regimen of dental scaling. Only Actinobaculum, TM7 and Leptotrichia were consistently reduced by all the three treatments, whereas the different microbial signatures of the three treatments during gingivitis relieve indicate distinct mechanisms of action. Our study suggests that microbiota based signatures can serve as a valuable approach for understanding and potentially comparing the modes of action for clinical treatments and oral-care products in the future.

  7. TVT versus TOT, 2-year prospective randomized study.

    Science.gov (United States)

    Wadie, Bassem S; El-Hefnawy, Ahmed S; Elhefnawy, Ahmed S

    2013-06-01

    To evaluate in a comprehensive way TVT in comparison with TOT, the results of a single-center RCT are presented. Many studies addressed efficacy and safety of TVT and TOT. Women included were adults having predominant SUI with positive stress test. They were randomized to get either TVT (Gynecare(®)) or TOT (Aris(®)). All women were seen 1 week, 3, 6, 12, 18, and 24 months. Seventy-one women completed 2-year follow-up. Median age was 47 (range 33-60 years). Mean ± SD BMI in TVT group was 34 ± 5 while in TOT group was 32 ± 5 kg/m(2). POP of any degree was seen in 50 % (35 women). At 1 year, pad test-negative women were 31 and 29 for TVT and TOT, respectively. At 2 years, figures became 28 in TVT group and 27 in TOT. At 1 year, UDI 6 and IIQ 7 decreased by 78.5 and 81 % for TVT and by 69 % and 75 % for TOT group. At 2 year, comparable percentages were 73 and 79 % for TVT and 69 and 82 % for TOT. Fifteen unique patients had adverse events, 10 of them had TOT. Both tapes have similar efficacy, regarding cure of incontinence. TVT is more effective, albeit insignificantly, than TOT at 2 years. However, serious adverse events were more frequent with TVT, yet TOT has more unique adverse events.

  8. Effects of psychological therapies in randomized trials and practice-based studies.

    Science.gov (United States)

    Barkham, Michael; Stiles, William B; Connell, Janice; Twigg, Elspeth; Leach, Chris; Lucock, Mike; Mellor-Clark, John; Bower, Peter; King, Michael; Shapiro, David A; Hardy, Gillian E; Greenberg, Leslie; Angus, Lynne

    2008-11-01

    Randomized trials of the effects of psychological therapies seek internal validity via homogeneous samples and standardized treatment protocols. In contrast, practice-based studies aim for clinical realism and external validity via heterogeneous samples of clients treated under routine practice conditions. We compared indices of treatment effects in these two types of studies. Using published transformation formulas, the Beck Depression Inventory (BDI) scores from five randomized trials of depression (N = 477 clients) were transformed into Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) scores and compared with CORE-OM data collected in four practice-based studies (N = 4,196 clients). Conversely, the practice-based studies' CORE-OM scores were transformed into BDI scores and compared with randomized trial data. Randomized trials showed a modest advantage over practice-based studies in amount of pre-post improvement. This difference was compressed or exaggerated depending on the direction of the transformation but averaged about 12%. There was a similarly sized advantage to randomized trials in rates of reliable and clinically significant improvement (RCSI). The largest difference was yielded by comparisons of effect sizes which suggested an advantage more than twice as large, reflecting narrower pre-treatment distributions in the randomized trials. Outcomes of completed treatments for depression in randomized trials appeared to be modestly greater than those in routine care settings. The size of the difference may be distorted depending on the method for calculating degree of change. Transforming BDI scores into CORE-OM scores and vice versa may be a preferable alternative to effect sizes for comparisons of studies using these measures.

  9. Comparison of the Effects of Religious Cognitive Behavioral Therapy (RCBT, Cognitive Behavioral Therapy (CBT, and Sertraline on Depression and Anxiety in Patients after Coronary Artery Bypass Graft Surgery: A Study Protocol for a Randomized Controlled T

    Directory of Open Access Journals (Sweden)

    Nazanin Vaezzadeh

    2017-06-01

    Full Text Available Objectives: Our objective is to compare the effects of RCBT, CBT, and sertraline on depression, anxiety, biomarker levels, and the quality of life in patients after coronary artery bypass graft (CABG surgery.Method/Design: This is a randomized controlled trial with parallel groups. A total of 160 patients after CABG surgery will be screened for anxiety and depression according to clinical interviews based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV criteria and Hospital  Anxiety Depression Scale (HADS scores (≥ 8. To assess religious attitude, Golriz and Baraheni’s religious attitude questionnaire will be used. Participants will be randomly allocated to four groups of 40 including three intervention groups (RCBT, CBT, and sertraline and one control group (usual care. RCBT and CBT programs will consist of 12 one-hour weekly sessions. The participants in the pharmacological intervention group will receive 25-200 mg/d of sertraline for three months. The (SF-36 will be administered to assess the patients’ quality of life. Blood samples will be taken and biomarker levels will be determined using the enzyme-linked immunosorbent assay (ELISA. The primary outcome will be the reduction in anxiety and depression scores after the interventions. The secondary outcomes will be increases in quality of life scores and normalized biomarker levels after the interventions.Discussion: If RCBT is found to be more effective than the other methods, it can be used to improve patients’ health status after CABG surgery.Irct ID: IRCT201404122898N5

  10. Celiac Patients: A Randomized, Controlled Clinical Study

    Directory of Open Access Journals (Sweden)

    Giuseppe Mazzarella

    2012-01-01

    Full Text Available A lifelong gluten-free diet (GFD is mandatory for celiac disease (CD but has poor compliance, justifying novel strategies. We found that wheat flour transamidation inhibited IFN-γ secretion by intestinal T cells from CD patients. Herein, the primary endpoint was to evaluate the ability of transamidated gluten to maintain GFD CD patients in clinical remission. Secondary endpoints were efficacy in prevention of the inflammatory response and safety at the kidney level, where reaction products are metabolized. In a randomized single blinded, controlled 90-day trial, 47 GFD CD patients received 3.7 g/day of gluten from nontransamidated (12 or transamidated (35 flour. On day 15, 75% and 37% of patients in the control and experimental groups, respectively, showed clinical relapse (=0.04 whereas intestinal permeability was mainly altered in the control group (50% versus 20%, =0.06. On day 90, 0 controls and 14 patients in the experimental group completed the challenge with no variation of antitransglutaminase IgA (=0.63, Marsh-Oberhuber grading (=0.08, or intestinal IFN-γ mRNA (>0.05. Creatinine clearance did not vary after 90 days of treatment (=0.46. In conclusion, transamidated gluten reduced the number of clinical relapses in challenged patients with no changes of baseline values for serological/mucosal CD markers and an unaltered kidney function.

  11. Comparison of a long-pulse Nd:YAG laser and a combined 585/1,064-nm laser for the treatment of acne scars: a randomized split-face clinical study.

    Science.gov (United States)

    Min, Seong U K; Choi, Yu Sung; Lee, Dong Hun; Yoon, Mi Young; Suh, Dae Hun

    2009-11-01

    Nonablative laser is gaining popularity because of the low risk of complications, especially in patients with darker skin. To compare the efficacy and safety of a long-pulse neodymium-doped yttrium aluminium garnet (Nd:YAG) laser and a combined 585/1,064-nm laser for the treatment of acne scars. Nineteen patients with mild to moderate atrophic acne scars received four long-pulse Nd:YAG laser or combined 585/1,064-nm laser treatment sessions at fortnightly intervals. Treatments were administered randomly in a split-face manner. Acne scars showed mild to moderate improvement, with significant Echelle d'évaluation clinique des cicatrices d'acné (ECCA) score reductions, after both treatments. Although intermodality differences were not significant, combined 585/1,064-nm laser was more effective for deep boxcar scars. In patients with combined 585/1,064-nm laser-treated sides that improved more than long-pulse Nd:YAG laser-treated sides, ECCA scores were significantly lower for combined 585/1,064-nm laser treatment. Histologic evaluations revealed significantly greater collagen deposition, although there was no significant difference between the two modalities. Patient satisfaction scores concurred with physicians' evaluations. Both lasers ameliorated acne scarring with minimal downtime. In light of this finding, optimal outcomes might be achieved when laser treatment types are chosen after considering individual scar type and response.

  12. A randomized direct comparison of the pharmacokinetics and pharmacodynamics of apixaban and rivaroxaban

    Directory of Open Access Journals (Sweden)

    Frost C

    2014-11-01

    Full Text Available Charles Frost,1 Yan Song,1 Yu Chen Barrett,1 Jessie Wang,2 Janice Pursley,3 Rebecca A Boyd,4 Frank LaCreta1 1Exploratory Clinical and Translational Research, 2Exploratory Development Global Biometric Sciences, 3Analytical and Bioanalytical Development, Bristol-Myers Squibb Company, Princeton, NJ, USA; 4Global Innovative Pharma Business Clinical Pharmacology, Pfizer Inc., Groton, CT, USA Background: Currently, there are no direct comparisons of apixaban and rivaroxaban, two new oral direct factor Xa inhibitors approved for management of thromboembolic disorders. Objective: Compare the pharmacokinetics and anti-factor Xa activity (AXA of apixaban and rivaroxaban. Methods: In this randomized, open-label, two-period, two-treatment crossover study, healthy subjects (N=14 received apixaban 2.5 mg twice daily (BID and rivaroxaban 10 mg once daily (QD for 4 days with a ≥4.5-day washout. Plasma samples were obtained for pharmacokinetic and AXA assessments; parameters were calculated using noncompartmental methods. Results: Median time-to-maximum concentration was 2 hours for both compounds, and the mean half-life was 8.7 and 7.9 hours for apixaban and rivaroxaban, respectively. Daily exposure, the area under the curve (AUC(0–24, appeared similar for rivaroxaban (1,094 ng · h/mL and apixaban (935 ng · h/mL, whereas mean peak-to-trough plasma concentration ratio was 3.6-fold greater for rivaroxaban (16.9 than apixaban (4.7. Coefficient of variation for exposure parameters (AUC0–24, Cmax, Cmin was 20%–24% for apixaban versus 29%–46% for rivaroxaban. Peak AXA, AXA AUC(0–24, and AXA fluctuation were ~2.5-, 1.3-, and 3.5-fold higher for rivaroxaban than apixaban, respectively. Trough concentrations and AXA were lower for rivaroxaban (10 ng/mL and 0.17 IU/mL vs 17 ng/mL and 0.24 IU/mL for apixaban, respectively. Rivaroxaban exhibited a steeper concentration–AXA response (slope: 0.0172 IU/ng vs 0.0134 IU/ng for apixaban, P<0.0001. Conclusion

  13. Comparison of granulocyte-macrophage colony-stimulating factor and sucralfate mouthwashes in the prevention of radiation-induced mucositis: a double-blind prospective randomized phase III study

    International Nuclear Information System (INIS)

    Saarilahti, Kauko; Kajanti, Mikael; Joensuu, Timo; Kouri, Mauri; Joensuu, Heikki

    2002-01-01

    Purpose: To compare granulocyte-macrophage colony-stimulating factor (GM-CSF) mouthwashes with sucralfate mouthwashes in the prevention of radiation-induced mucositis. Methods and Materials: Forty patients with radically operated head-and-neck cancer were randomly allocated to use either GM-CSF (n=21) or sucralfate (n=19) mouthwashes during postoperative radiotherapy (RT). All patients received conventionally fractionated RT to a total dose of 50-60 Gy in 2-Gy daily fractions during 5-6 weeks to the primary site and regional lymphatics. A minimum of 50% of the oral cavity and oropharyngeal mucosa was included in the clinical target volume. GM-CSF mouthwashes consisted of 37.5 μg GM-CSF and sucralfate mouthwashes of 1.0 g of sucralfate distilled in water. Both washes were used 4 times daily, beginning after the first week of RT and continued to the end of the RT course. Symptoms related to radiation mucositis and body weight, serum prealbumin level, and blood cell counts were monitored weekly. Results: Oral mucositis tended to be less severe in the GM-CSF group (p=0.072). Complete (n=1) or partial (n=4) healing of mucositis occurred during the RT course in 5 patients (24%) in the GM-CSF group and in none of the patients in the sucralfate group (p=0.049). Patients who received GM-CSF had less mucosal pain (p=0.058) and were less often prescribed opioids for pain (p=0.042). Three patients in the sucralfate group needed hospitalization for mucositis during RT compared with none in the GM-CSF group. Four patients (21%) in the sucralfate group and none in the GM-CSF group required an interruption in the RT course (p=0.042). No significant differences in weight, prealbumin level, or blood cell count were found between the groups, and both mouthwashes were well tolerated. Conclusion: GM-CSF mouthwashes may be moderately more effective than sucralfate mouthwashes in preventing radiation-induced mucositis and mucositis-related pain, and their use may lead to less frequent

  14. Comparison of a novel porous titanium construct (Regenerex®) to a well proven porous coated tibial surface in cementless total knee arthroplasty - A prospective randomized RSA study with two-year follow-up

    DEFF Research Database (Denmark)

    Winther, Nikolaj Sebastian; Jensen, Claus Lindkær; Jensen, Claus Munk

    2016-01-01

    BACKGROUND: Regenerex is a novel porous titanium construct with a three-dimensional porous structure and biomechanical characteristics close to that of normal trabecular bone. The aim of this study was to compare this novel construct to a well-proven porous plasma sprayed tibial (PPS) implant aft...

  15. Randomized, Prospective Comparison of Ursodeoxycholic Acid for the Prevention of Gallstones after Sleeve Gastrectomy.

    Science.gov (United States)

    Adams, Lindsay B; Chang, Craig; Pope, Janet; Kim, Yeonsoo; Liu, Pei; Yates, Amy

    2016-05-01

    Several studies have examined the role of ursodeoxycholic acid (UDCA) for the prevention of cholelithiasis (gallstones) following rapid weight loss from restrictive diets, vertical band gastroplasty, and Roux-en-Y gastric bypass. However, to date, there have been no prospective, controlled studies examining the role of UDCA for the prevention of gallstones following sleeve gastrectomy (SG). This study was conducted to identify the effectiveness of UDCA for prevention of gallstones after SG. Following SG, eligible patients were randomized to a control group who did not receive UDCA treatment or to a group who were prescribed 300 mg UDCA twice daily for 6 months. Gallbladder ultrasounds were performed preoperatively and at 6 and 12 months postoperatively. Patients with positive findings preoperatively were excluded from the study. Compliance with UDCA was assessed. Between December 2011 and April 2013, 37 patients were randomized to the UDCA treatment arm and 38 patients were randomized to no treatment. At baseline, the two groups were similar. At 6 months, the UDCA group had a statistically significant lower incidence of gallstones (p = 0.032). Analysis revealed no significant difference in gallstones between the two groups at 1 year (p = 0.553 and p = 0.962, respectively). The overall gallstone formation rate was 29.8%. The incidence of gallstones is higher than previously estimated in SG patients. UDCA significantly lowers the gallstone formation rate at 6 months postoperatively.

  16. COMPARISON OF ASTYM THERAPY AND KINESIOTAPING FOR ROTATOR CUFF TENDINOPATHY IN DIABETIC PATIENTS: RANDOMIZED CONTROLLED TRIAL

    OpenAIRE

    Azza Atya; Mahmoud Nasser; Aisha Hagag

    2017-01-01

    Background: Rotator cuff tendinopathy is a significant problem among diabetics that frequently restricts patient’s activity in terms of pain and disability. The purpose of this study was to compare between the effect of Astym therapy and kinesiotaping in treating diabetic patients with chronic rotator cuff tendinopathy. Methods: 56 diabetic patients diagnosed with chronic rotator cuff tendinopathy were randomly assigned into Astym therapy group (n=28) or kinesiotaping group (n= 28). All pa...

  17. Randomized double-blind comparison of metoprolol, nifedipine, and their combination in chronic stable angina

    DEFF Research Database (Denmark)

    Egstrup, K

    1988-01-01

    In a randomized double-blind study, treatment with either metoprolol, nifedipine, or their combination was compared for effects on ischemic variables and heart rate obtained during ambulatory monitoring in 42 patients with chronic stable angina. All patients had severe chronic stable angina...... could be detected during nifedipine monotherapy. It is concluded that metoprolol monotherapy, as well as its combination with nifedipine, effectively reduces total ischemic activity compared with placebo and nifedipine monotherapy. Control of ischemic activity in chronic stable angina may have...

  18. The Effects of Improvisational Music Therapy on Joint Attention Behaviors in Autistic Children: A Randomized Controlled Study

    Science.gov (United States)

    Kim, Jinah; Wigram, Tony; Gold, Christian

    2008-01-01

    The purpose of this study was to investigate the effects of improvisational music therapy on joint attention behaviors in pre-school children with autism. It was a randomized controlled study employing a single subject comparison design in two different conditions, improvisational music therapy and play sessions with toys, and using standardized…

  19. COMPARISON BETWEEN POST ISOMETRIC RELAXATION AND RECIPROCAL INHIBITION MANUEVERS ON HAMSTRING FLEXIBILITY IN YOUNG HEALTHY ADULTS: RANDOMIZED CLINICAL TRIAL

    Directory of Open Access Journals (Sweden)

    Agrawal Sonal S

    2016-01-01

    Full Text Available Background & Purpose: Variations in the application of muscle energy technique (MET for increasing the extensibility of muscles have been advocated, but little evidence exists to support the relative merit of a particular approach. This study investigated two types of muscle energy techniques that have been advocated in the osteopathic literature that differ primarily in the muscle group targeted. Aim: To compare the efficacy of Post Isometric Relaxation (PIR and Reciprocal Inhibition (RI on hamstring length in young healthy adults Methodology: Randomized clinical trial 100 college students aged between 18-25 years were included. The subjects were randomly assigned to PIR and RI group. Each group consisted of 50 subjects (25 male, 25 female. Knee extension limitation was measured by using active knee extension test (AKET pre & post-intervention, i.e. after 3 weeks of stretching regimen, with the help of universal full circle goniometer. Results: There was significant improvement in hamstrings flexibility (p=0.000 in both PIR and RI groups. Statistical comparison of the results of both the technique showed that PIR group had greater improvement than the RI group (p=0.000 Conclusion: PIR and RI were both found to be effective in improving hamstring flexibility but, PIR is more effective therapeutic maneuver.

  20. Sexuality and Body Image After Uterine Artery Embolization and Hysterectomy in the Treatment of Uterine Fibroids: A Randomized Comparison

    International Nuclear Information System (INIS)

    Hehenkamp, Wouter J. K.; Volkers, Nicole A.; Bartholomeus, Wouter; Blok, Sjoerd de; Birnie, Erwin; Reekers, Jim A.; Ankum, Willem M.

    2007-01-01

    In this paper the effect of uterine artery embolization (UAE) on sexual functioning and body image is investigated in a randomized comparison to hysterectomy for symptomatic uterine fibroids. The EMbolization versus hysterectoMY (EMMY) trial is a randomized controlled study, conducted at 28 Dutch hospitals. Patients were allocated hysterectomy (n = 89) or UAE (n 88). Two validated questionnaires (the Sexual Activity Questionnaire [SAQ] and the Body Image Scale [BIS]) were completed by all patients at baseline, 6 weeks, and 6, 12, 18, and 24 months after treatment. Repeated measurements on SAQ scores revealed no differences between the groups. There was a trend toward improved sexual function in both groups at 2 years, although this failed to reach statistical significance except for the dimensions discomfort and habit in the UAE arm. Overall quality of sexual life deteriorated in a minority of cases at all time points, with no significant differences between the groups (at 24 months: UAE, 29.3%, versus hysterectomy, 23.5%; p = 0.32). At 24 months the BIS score had improved in both groups compared to baseline, but the change was only significant in the UAE group (p = 0.009). In conclusion, at 24 months no differences in sexuality and body image were observed between the UAE and the hysterectomy group. On average, both after UAE and hysterectomy sexual functioning and body image scores improved, but significantly so only after UAE

  1. Comparison of clinical efficacy and safety of thermotherapy versus cryotherapy in treatment of skin warts: A randomized controlled trial.

    Science.gov (United States)

    Izadi Firouzabadi, Leila; Khamesipour, Ali; Ghandi, Narges; Hosseini, Hamed; Teymourpour, Amir; Firooz, Alireza

    2018-01-01

    The effect of thermotherapy in the treatment of skin warts in comparison to cryotherapy, as the standard conventional method, has remained uncertain. This study aimed to assess the clinical efficacy and safety of thermotherapy and cryotherapy in removing skin warts. This randomized controlled trial was conducted on 52 patients aged 18 years and over with ≤ 10 skin warts. The participants were randomly assigned into two groups to receive cryotherapy (every 2 to 3 weeks up to six sessions if required) or thermotherapy (one session). The patients in both groups were followed every 2 to 3 weeks for the first three months, and then three months after the last treatment session. The clearance rate was 79.2% in the thermotherapy group and 58.3% in the cryotherapy group with no significant difference (p = 0.212). The rate of scarring in the thermotherapy group was 20% (p = .018). A higher clearance rate was achieved in the thermotherapy group. However, this result was not statistically significant. There were some minimal post-treatment complications. Patients needed only one session of thermotherapy. Due to the risk of scarring, we suggest thermotherapy only as a suitable treatment method for palmoplantar warts. © 2017 Wiley Periodicals, Inc.

  2. Comparison of vildagliptin as an add-on therapy and sulfonylurea dose-increasing therapy in patients with inadequately controlled type 2 diabetes using metformin and sulfonylurea (VISUAL study): A randomized trial.

    Science.gov (United States)

    Hong, A Ram; Lee, Jeun; Ku, Eu Jeong; Hwangbo, Yul; Kim, Kyoung Min; Moon, Jae Hoon; Choi, Sung Hee; Jang, Hak Chul; Lim, Soo

    2015-07-01

    The aim of present study is to compare the efficacy and safety of adding vildagliptin with sulfonylurea dose-increasing as an active comparator in patients who had inadequately controlled type 2 diabetes mellitus (T2DM) using metformin plus sulfonylurea in real clinical practice. Patients using metformin plus sulfonylurea were assigned to either vildagliptin add-on (50 mg twice a day, n=172) or sulfonylurea dose-increasing by 50% (n=172) treatment groups. The primary endpoint was a change in HbA(1c) after 24 weeks. The secondary endpoints were patients achieving HbA(1c)≤7.0% (53 mmol/mol) and changes in the fasting plasma glucose (FPG), 2-h postprandial glucose (2pp), lipid profiles, and urine albumin-to-creatinine ratio. Body weight and hypoglycemia were also investigated. The mean HbA(1c) at baseline was 8.6% (70 mmol/mol) in both groups. At week 24, the adjusted mean HbA(1c) levels decreased by -1.19% (-13.09 mmol/mol) with vildagliptin add-on and -0.46% (-5.06 mmol/mol) with sulfonylurea (Pvildagliptin add-on patients achieved HbA(1c)≤7.0% (53 mmol/mol) than did sulfonylurea patients (40.1% vs. 7.9%; Pvildagliptin add-on than with sulfonylurea (Pvildagliptin add-on group exhibited no clinically relevant weight gain and had a lower incidence of hypoglycemia compared with the sulfonylurea group. Vildagliptin add-on therapy might be a suitable option for patients with T2DM that is controlled inadequately by metformin and sulfonylurea, based on its greater glucose control and better safety profile (ClinicalTrial.gov: NCT01099137). Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  3. Comparison of a GPS needle-tracking system, multiplanar imaging and 2D imaging for real-time ultrasound-guided epidural anaesthesia: A randomized, comparative, observer-blinded study on phantoms.

    Science.gov (United States)

    Menacé, Cécilia; Choquet, Olivier; Abbal, Bertrand; Bringuier, Sophie; Capdevila, Xavier

    2017-04-01

    The real-time ultrasound-guided paramedian sagittal oblique approach for neuraxial blockade is technically demanding. Innovative technologies have been developed to improve nerve identification and the accuracy of needle placement. The aim of this study was to evaluate three types of ultrasound scans during ultrasound-guided epidural lumbar punctures in a spine phantom. Eleven sets of 20 ultrasound-guided epidural punctures were performed with 2D, GPS, and multiplanar ultrasound machines (660 punctures) on a spine phantom using an in-plane approach. For all punctures, execution time, number of attempts, bone contacts, and needle redirections were noted by an independent physician. Operator comfort and visibility of the needle (tip and shaft) were measured using a numerical scale. The use of GPS significantly decreased the number of punctures, needle repositionings, and bone contacts. Comfort of the physician was also significantly improved with the GPS system compared with the 2D and multiplanar systems. With the multiplanar system, the procedure was not facilitated and execution time was longer compared with 2D imaging after Bonferroni correction but interaction between the type of ultrasound system and mean execution time was not significant in a linear mixed model. There were no significant differences regarding needle tip and shaft visibility between the systems. Multiplanar and GPS needle-tracking systems do not reduce execution time compared with 2D imaging using a real-time ultrasound-guided paramedian sagittal oblique approach in spine phantoms. The GPS needle-tracking system can improve performance in terms of operator comfort, the number of attempts, needle redirections and bone contacts. Copyright © 2016 Société française d'anesthésie et de réanimation (Sfar). Published by Elsevier Masson SAS. All rights reserved.

  4. A prospective randomized comparison of curved array and radial echoendoscopy in patients with esophageal cancer

    DEFF Research Database (Denmark)

    Siemsen, Mette; Svendsen, Lars Bo; Knigge, Ulrich

    2003-01-01

    BACKGROUND: Both curved array and radial scanning echoendoscopy are used for locoregional staging of cancer arising in the esophagus or cardia. The accuracy of TNM staging of these malignancies by curved array and radial EUS was compared in a prospective, randomized study. METHODS: Patients...... with cancer of the esophagus or cardia were examined by both curved array and radial echoendoscopy in randomized order by the same endosonographer in an unblinded fashion. The staging results and the examination time for the two echoendoscopies were compared and statistically analyzed, and finally compared......, respectively, 15 and 12 minutes (pcancer of the esophagus or cardia. The choice of echoendoscope for TNM staging in patients with these malignancies is, therefore, a question...

  5. A Monte Carlo study of adsorption of random copolymers on random surfaces

    CERN Document Server

    Moghaddam, M S

    2003-01-01

    We study the adsorption problem of a random copolymer on a random surface in which a self-avoiding walk in three dimensions interacts with a plane defining a half-space to which the walk is confined. Each vertex of the walk is randomly labelled A with probability p sub p or B with probability 1 - p sub p , and only vertices labelled A are attracted to the surface plane. Each lattice site on the plane is also labelled either A with probability p sub s or B with probability 1 - p sub s , and only lattice sites labelled A interact with the walk. We study two variations of this model: in the first case the A-vertices of the walk interact only with the A-sites on the surface. In the second case the constraint of selective binding is removed; that is, any contact between the walk and the surface that involves an A-labelling, either from the surface or from the walk, is counted as a visit to the surface. The system is quenched in both cases, i.e. the labellings of the walk and of the surface are fixed as thermodynam...

  6. Evolutionary dynamics of adult stem cells: comparison of random and immortal-strand segregation mechanisms.

    Science.gov (United States)

    Tannenbaum, Emmanuel; Sherley, James L; Shakhnovich, Eugene I

    2005-04-01

    This paper develops a point-mutation model describing the evolutionary dynamics of a population of adult stem cells. Such a model may prove useful for quantitative studies of tissue aging and the emergence of cancer. We consider two modes of chromosome segregation: (1) random segregation, where the daughter chromosomes of a given parent chromosome segregate randomly into the stem cell and its differentiating sister cell and (2) "immortal DNA strand" co-segregation, for which the stem cell retains the daughter chromosomes with the oldest parent strands. Immortal strand co-segregation is a mechanism, originally proposed by [Cairns Nature (London) 255, 197 (1975)], by which stem cells preserve the integrity of their genomes. For random segregation, we develop an ordered strand pair formulation of the dynamics, analogous to the ordered strand pair formalism developed for quasispecies dynamics involving semiconservative replication with imperfect lesion repair (in this context, lesion repair is taken to mean repair of postreplication base-pair mismatches). Interestingly, a similar formulation is possible with immortal strand co-segregation, despite the fact that this segregation mechanism is age dependent. From our model we are able to mathematically show that, when lesion repair is imperfect, then immortal strand co-segregation leads to better preservation of the stem cell lineage than random chromosome segregation. Furthermore, our model allows us to estimate the optimal lesion repair efficiency for preserving an adult stem cell population for a given period of time. For human stem cells, we obtain that mispaired bases still present after replication and cell division should be left untouched, to avoid potentially fixing a mutation in both DNA strands.

  7. Cardiac effects of granisetron in a prospective crossover randomized dose comparison trial.

    Science.gov (United States)

    Cakir, F B; Yapar, O; Canpolat, C; Akalin, F; Berrak, S G

    2012-10-01

    Cardiac side effects of granisetron have been studied mostly in adult patients that are using cardiotoxic chemotherapeutics. There is limited evidence in pediatric age group and no information in pediatric oncology patients with non-cardiotoxic chemotherapeutics. In this prospective, crossover randomized study, the cardiac side effects of granisetron are compared in pediatric oncology patients who had carboplatin based chemotherapy. They were randomized to receive either 10 or 40 μg kg(-1) dose(-1) of granisetron before each cycle of chemotherapy. We drew blood for creatine phosphokinase (CPK), CPK-muscle band (MB) and Troponin-T before and 24 h after administering granisetron. Electrocardiography (ECG) tracings were taken at 0, 1, 2, 3, 6 and 24 h of granisetron. Twenty-four hours Holter ECG monitorisation was performed after each granisetron infusion. A total of 16 patients (median 8.7 years of age) were treated with weekly consecutive courses of carboplatin. There was bradycardia (p = 0.000) in patients that had granisetron at 40 μg/kg and PR interval was shortened in patients that had granisetron at 10 μg/kg dose (p = 0.021). At both doses of granisetron, QTc interval and dispersion were found to be similar. CPK, CK-MB and Troponin-T values were found to be normal before and 24 h after granisetron infusion. As the first study that has studied cardiac side effects of granisetron in patients that are not using cardiotoxic chemotherapeutics, we conclude that granisetron at 40 μg kg(-1) dose(-1) causes bradycardia only. We have also demonstrated that granisetron does not cause any clinically cardiac side effects either at 10 or 40 μg kg(-1) dose(-1). However, our results should be supported by prospective randomized studies with larger samples of patient groups.

  8. Empirical comparison of four baseline covariate adjustment methods in analysis of continuous outcomes in randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Zhang S

    2014-07-01

    Full Text Available Shiyuan Zhang,1 James Paul,2 Manyat Nantha-Aree,2 Norman Buckley,2 Uswa Shahzad,2 Ji Cheng,2 Justin DeBeer,5 Mitchell Winemaker,5 David Wismer,5 Dinshaw Punthakee,5 Victoria Avram,5 Lehana Thabane1–41Department of Clinical Epidemiology and Biostatistics, 2Department of Anesthesia, McMaster University, Hamilton, ON, Canada; 3Biostatistics Unit/Centre for Evaluation of Medicines, St Joseph's Healthcare - Hamilton, Hamilton, ON, Canada; 4Population Health Research Institute, Hamilton Health Science/McMaster University, 5Department of Surgery, Division of Orthopaedics, McMaster University, Hamilton, ON, CanadaBackground: Although seemingly straightforward, the statistical comparison of a continuous variable in a randomized controlled trial that has both a pre- and posttreatment score presents an interesting challenge for trialists. We present here empirical application of four statistical methods (posttreatment scores with analysis of variance, analysis of covariance, change in scores, and percent change in scores, using data from a randomized controlled trial of postoperative pain in patients following total joint arthroplasty (the Morphine COnsumption in Joint Replacement Patients, With and Without GaBapentin Treatment, a RandomIzed ControlLEd Study [MOBILE] trials.Methods: Analysis of covariance (ANCOVA was used to adjust for baseline measures and to provide an unbiased estimate of the mean group difference of the 1-year postoperative knee flexion scores in knee arthroplasty patients. Robustness tests were done by comparing ANCOVA with three comparative methods: the posttreatment scores, change in scores, and percentage change from baseline.Results: All four methods showed similar direction of effect; however, ANCOVA (-3.9; 95% confidence interval [CI]: -9.5, 1.6; P=0.15 and the posttreatment score (-4.3; 95% CI: -9.8, 1.2; P=0.12 method provided the highest precision of estimate compared with the change score (-3.0; 95% CI: -9.9, 3.8; P=0

  9. Efficacy of peloid therapy in patients with chronic lateral epicondylitis: a randomized, controlled, single blind study

    Science.gov (United States)

    Ökmen, Burcu Metin; Eröksüz, Rıza; Altan, Lale; Aksoy, Meliha Kasapoğlu

    2017-11-01

    The aim of this study was to assess the effect of peloid on pain, functionality, daily life activities, and quality of life of lateral epicondylitis (LE) patients. In this randomized, controlled, single-blind study, 75 patients who were diagnosed with chronic LE were enrolled to the study. Patients were randomized into two groups using the random number table. The patients in the first group (group 1) ( n = 33), were given lateral epicondylitis band (LEB) (during the day for 6 weeks) + peloid therapy (five consecutive days a week for 2 weeks), and the second group (group 2) ( n = 32), received LEB treatment alone. The patients were assessed by using Patient Rated Tennis Elbow Evaluation (PRTEE) and Nottingham Health Profile (NHP). The data were obtained before treatment (W0), immediately after treatment (W2), and 1 month after treatment (W6). In analysis of the collected data, the Wilcoxon signed rank test for intra-group comparisons and Mann-Whitney U test for comparisons between groups were used. Both in groups 1 and 2, there was a statistically significant improvement in all the evaluation parameters at W2 and W6 when compared to W0 ( p 0.05), a statistically significant difference was found in favor of group 1 for all the evaluation parameters at W6 ( p < 0.05). Our results have shown that peloid treatment could be effective in providing improvement in pain relief, function, daily life activities, and quality of life in LE patients.

  10. Study on random number generator in Monte Carlo code

    International Nuclear Information System (INIS)

    Oya, Kentaro; Kitada, Takanori; Tanaka, Shinichi

    2011-01-01

    The Monte Carlo code uses a sequence of pseudo-random numbers with a random number generator (RNG) to simulate particle histories. A pseudo-random number has its own period depending on its generation method and the period is desired to be long enough not to exceed the period during one Monte Carlo calculation to ensure the correctness especially for a standard deviation of results. The linear congruential generator (LCG) is widely used as Monte Carlo RNG and the period of LCG is not so long by considering the increasing rate of simulation histories in a Monte Carlo calculation according to the remarkable enhancement of computer performance. Recently, many kinds of RNG have been developed and some of their features are better than those of LCG. In this study, we investigate the appropriate RNG in a Monte Carlo code as an alternative to LCG especially for the case of enormous histories. It is found that xorshift has desirable features compared with LCG, and xorshift has a larger period, a comparable speed to generate random numbers, a better randomness, and good applicability to parallel calculation. (author)

  11. Thromboembolism and mechanical heart valves : A randomized study revisited

    NARCIS (Netherlands)

    Kuntze, CEE; Blackstone, EH; Ebels, T

    Background. This study was designed to revise and substantiate previous inferences, based on short-term follow-up, about differences in the incidence of anticoagulant-related events after heart valve replacement among patients who had been randomly assigned to receive either a Bjork-Shiley,

  12. Recruitment of young adults for weight gain prevention: randomized comparison of direct mail strategies.

    Science.gov (United States)

    Crane, Melissa M; LaRose, Jessica Gokee; Espeland, Mark A; Wing, Rena R; Tate, Deborah F

    2016-06-08

    Recruiting young adults (ages 18-35 years) into weight gain prevention intervention studies is challenging and men are particularly difficult to reach. This paper describes two studies designed to improve recruitment for a randomized trial of weight gain prevention interventions. Study 1 used a quasi-experimental design to test the effect of two types of direct mailings on their overall reach. Study 2 used a randomized design to test the effect of using targeted messages to increase recruitment of men into the trial. For Study 1, 60,000 male and female young-adult households were randomly assigned to receive either a recruitment brochure or postcard. Visits to recruitment websites during each mailing period were used to assess response to each mailing. Study 2 focused on postcard recruitment only. These households received either a targeted or generic recruitment postcard, where targeted postcards included the word "Men" in the headline text. Response rates to each type of card were categorized based on participant report of mailing received. The reach of the postcards and brochures were similar (421 and 386 website visits, respectively; P = 0.22). Individuals who received the brochure were more likely to initiate the online screener than those who received a postcard (P = 0.01). In Study 2, of those who completed the telephone screening, 60.9 % of men (n = 23) had received the targeted postcard as compared to the generic postcard (39.1 %, P = 0.30). The reverse was true for women (n = 62, 38.7 vs. 61.3 %, P = 0.08). These studies suggest there was little difference in the reach of postcards versus brochures. However, recipients of brochures were more likely to continue to the next stage of study participation. As expected, men's response to the weight gain prevention messages was lower than women's response; but using targeted messages appears to have modestly increased the proportion of male respondents. These studies add to the limited

  13. Scattering by a slab containing randomly located cylinders: comparison between radiative transfer and electromagnetic simulation.

    Science.gov (United States)

    Roux, L; Mareschal, P; Vukadinovic, N; Thibaud, J B; Greffet, J J

    2001-02-01

    This study is devoted to the examination of scattering of waves by a slab containing randomly located cylinders. For the first time to our knowledge, the complete transmission problem has been solved numerically. We have compared the radiative transfer theory with a numerical solution of the wave equation. We discuss the coherent effects, such as forward-scattering dip and backscattering enhancement. It is seen that the radiative transfer equation can be used with great accuracy even for optically thin systems whose geometric thickness is comparable with the wavelength. We have also shown the presence of dependent scattering.

  14. A comparison of methods for representing random taste heterogeneity in discrete choice models

    DEFF Research Database (Denmark)

    Fosgerau, Mogens; Hess, Stephane

    2009-01-01

    This paper reports the findings of a systematic study using Monte Carlo experiments and a real dataset aimed at comparing the performance of various ways of specifying random taste heterogeneity in a discrete choice model. Specifically, the analysis compares the performance of two recent advanced...... distributions. Both approaches allow the researcher to increase the number of parameters as desired. The paper provides a range of evidence on the ability of the various approaches to recover various distributions from data. The two advanced approaches are comparable in terms of the likelihoods achieved...

  15. A comparison of two least-squared random coefficient autoregressive models: with and without autocorrelated errors

    OpenAIRE

    Autcha Araveeporn

    2013-01-01

    This paper compares a Least-Squared Random Coefficient Autoregressive (RCA) model with a Least-Squared RCA model based on Autocorrelated Errors (RCA-AR). We looked at only the first order models, denoted RCA(1) and RCA(1)-AR(1). The efficiency of the Least-Squared method was checked by applying the models to Brownian motion and Wiener process, and the efficiency followed closely the asymptotic properties of a normal distribution. In a simulation study, we compared the performance of RCA(1) an...

  16. Interfacial separation between elastic solids with randomly rough surfaces: comparison of experiment with theory

    Energy Technology Data Exchange (ETDEWEB)

    Lorenz, B; Persson, B N J [IFF, FZ-Juelich, D-52425 Juelich (Germany)

    2009-01-07

    We study the average separation between an elastic solid and a hard solid, with a nominally flat but randomly rough surface, as a function of the squeezing pressure. We present experimental results for a silicon rubber (PDMS) block with a flat surface squeezed against an asphalt road surface. The theory shows that an effective repulsive pressure acts between the surfaces of the form p{approx}exp(-u/u{sub 0}), where u is the average separation between the surfaces and u{sub 0} a constant of the order of the root-mean-square roughness, in good agreement with the experimental results.

  17. Analysis of cost data in a cluster-randomized, controlled trial: comparison of methods

    DEFF Research Database (Denmark)

    Sokolowski, Ineta; Ørnbøl, Eva; Rosendal, Marianne

    studies have used non-valid analysis of skewed data. We propose two different methods to compare mean cost in two groups. Firstly, we use a non-parametric bootstrap method where the re-sampling takes place on two levels in order to take into account the cluster effect. Secondly, we proceed with a log......-transformation of the cost data and apply the normal theory on these data. Again we try to account for the cluster effect. The performance of these two methods is investigated in a simulation study. The advantages and disadvantages of the different approaches are discussed.......  We consider health care data from a cluster-randomized intervention study in primary care to test whether the average health care costs among study patients differ between the two groups. The problems of analysing cost data are that most data are severely skewed. Median instead of mean...

  18. Cardiorespiratory Kinetics Determined by Pseudo-Random Binary Sequences - Comparisons between Walking and Cycling.

    Science.gov (United States)

    Koschate, J; Drescher, U; Thieschäfer, L; Heine, O; Baum, K; Hoffmann, U

    2016-12-01

    This study aims to compare cardiorespiratory kinetics as a response to a standardised work rate protocol with pseudo-random binary sequences between cycling and walking in young healthy subjects. Muscular and pulmonary oxygen uptake (V̇O 2 ) kinetics as well as heart rate kinetics were expected to be similar for walking and cycling. Cardiac data and V̇O 2 of 23 healthy young subjects were measured in response to pseudo-random binary sequences. Kinetics were assessed applying time series analysis. Higher maxima of cross-correlation functions between work rate and the respective parameter indicate faster kinetics responses. Muscular V̇O 2 kinetics were estimated from heart rate and pulmonary V̇O 2 using a circulatory model. Muscular (walking vs. cycling [mean±SD in arbitrary units]: 0.40±0.08 vs. 0.41±0.08) and pulmonary V̇O 2 kinetics (0.35±0.06 vs. 0.35±0.06) were not different, although the time courses of the cross-correlation functions of pulmonary V̇O 2 showed unexpected biphasic responses. Heart rate kinetics (0.50±0.14 vs. 0.40±0.14; P=0.017) was faster for walking. Regarding the biphasic cross-correlation functions of pulmonary V̇O 2 during walking, the assessment of muscular V̇O 2 kinetics via pseudo-random binary sequences requires a circulatory model to account for cardio-dynamic distortions. Faster heart rate kinetics for walking should be considered by comparing results from cycle and treadmill ergometry. © Georg Thieme Verlag KG Stuttgart · New York.

  19. Randomized Comparison of Dry Dressings Versus Hydrogel in Management of Radiation-Induced Moist Desquamation

    International Nuclear Information System (INIS)

    Macmillan, Maureen S.; Wells, Mary; MacBride, Sheila; Raab, Gillian M.; Munro, Alastair; MacDougall, Hugh

    2007-01-01

    Purpose: We present the results of a randomized controlled clinical trial that evaluated the effect of a hydrogel or dry dressing on the time to healing of moist desquamation after radiotherapy to the head-and-neck, breast, or anorectal areas. Methods and Materials: A total of 357 patients were randomized before radiotherapy to receive simple dry dressings (Tricotex) or a hydrogel (Intrasite), with Tricotex as a secondary dressing. Patients were instructed to use their dressings from the onset of moist desquamation, if it occurred. Results: Of the 357 patients, 100 (28%) developed moist desquamation. The time to healing was significantly prolonged (hazard ratio, 0.64; 95% confidence interval, 0.42-0.99), in patients assigned to gel dressings. No evidence was found that gel dressings had a significant impact on subjectively reported skin symptoms. Conclusion: The results of this study have not supported the routine use of hydrogels in the care of patients with moist desquamation and suggests that the healing times are prolonged, without any improvement in patient comfort

  20. Comparison of sugammadex and conventional reversal on postoperative nausea and vomiting: a randomized, blinded trial.

    Science.gov (United States)

    Koyuncu, Onur; Turhanoglu, Selim; Ozbakis Akkurt, Cagla; Karcıoglu, Murat; Ozkan, Mustafa; Ozer, Cahit; Sessler, Daniel I; Turan, Alparslan

    2015-02-01

    To determine whether the new selective binding agent sugammadex causes less postoperative nausea and vomiting (PONV) than the cholinesterase inhibitor neostigmine. Prospective, randomized, double-blinded study. University-affiliated hospital. One hundred American Society of Anesthesiologists physical status 1 and 2 patients scheduled for extremity surgery. Patients were randomly assigned to neostigmine (70 μg/kg) and atropine (0.4 mg per mg neostigmine) or sugammadex 2 mg/kg for neuromuscular antagonism at the end of anesthesia, when 4 twitches in response to train-of-four stimulation were visible with fade. We recorded PONV, recovery parameters, antiemetic consumption, and side effects. Nausea and vomiting scores were lower in the sugammadex patients upon arrival in the postanesthesia care unit (med: 0 [min-max, 0-3] vs med: 0 [min-max, 0-3]; P sugammadex. Postoperative heart rates were significantly lower in all measured times patients given neostigmine. Nondepolarizing neuromuscular blocking antagonism with sugammadex speeds recovery of neuromuscular strength but only slightly and transiently reduces PONV compared with neostigmine and atropine. Copyright © 2014 Elsevier Inc. All rights reserved.

  1. PRK and butterfly LASEK: prospective, randomized, contralateral eye comparison of epithelial healing and ocular discomfort.

    Science.gov (United States)

    Ghanem, Vinícius C; Souza, Giselle C; Souza, Denise C; Viese, Juliana M Z; Weber, Sarah L P; Kara-José, Newton

    2008-06-01

    To compare corneal reepithelialization, pain scores, ocular discomfort, and tear production after photorefractive keratectomy (PRK) and butterfly laser epithelial keratomileusis (LASEK). This prospective, randomized, double-masked study comprised 102 eyes of 51 patients who underwent laser refractive surgery. Each patient was randomized to have one eye operated on with PRK and the other with butterfly LASEK. Patients were followed for 1 year. The mean reepithelialization time in the PRK group was 4.35+/-0.48 days (range: 4 to 5 days) and 4.75+/-0.72 days (range: 4 to 6 days) in the butterfly LASEK group (PPRK was noted (3.31+/-4.09 vs 4.43+/-4.27; P=.18). Schirmer test values were significantly reduced from preoperative levels through 12 months with both PRK (23.6+/-8.1 vs 19.4+/-10.1; P<.002) and butterfly LASEK (22.4+/-8.7 vs 18.9+/-9.7; P=.01); however, no difference between groups was noted at any time. Photorefractive keratectomy showed a modest but statistically significant shorter reepithelialization time and a tendency towards lower pain scores than butterfly LASEK. The reepithelialization time was strongly associated with the duration of surgery in both techniques. A similar reduction of Schirmer test values was observed up to 1 year postoperatively in both groups.

  2. Custom vs conventional PRK: a prospective, randomized, contralateral eye comparison of postoperative visual function.

    Science.gov (United States)

    Mifflin, Mark D; Hatch, Bryndon B; Sikder, Shameema; Bell, James; Kurz, Christopher J; Moshirfar, Majid

    2012-02-01

    To determine whether VISX S4 (VISX Inc) custom photorefractive keratectomy (PRK) results in better visual outcomes than VISX S4 conventional PRK. Photorefractive keratectomy was performed on 80 eyes from 40 patients in this randomized, prospective, contralateral eye study. Dominant eyes were randomized to one group with the fellow eye receiving the alternate treatment. Primary outcome measures included uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), contrast sensitivity, and root-mean-square (RMS) higher order aberrations. Mean UDVA was -0.023±0.099 (20/19) in the custom group and -0.044±0.080 (20/18) in the conventional group 6 months after surgery (P=.293). Mean CDVA was -0.073±0.067 (20/17) in the custom group and -0.079±0.071 (20/17) in the conventional group 6 months after surgery (P=.659). Total higher order aberration RMS and spherical aberration increased in both groups compared to preoperative values (PPRK were shown to be safe and effective with excellent visual acuity and contrast sensitivity performance at 6 and 12 months. Conventional PRK induced more coma than custom PRK; however, this did not seem to correlate with clinical outcomes. Copyright 2012, SLACK Incorporated.

  3. Comparison of cell behavior on pva/pva-gelatin electrospun nanofibers with random and aligned configuration

    Science.gov (United States)

    Huang, Chen-Yu; Hu, Keng-Hsiang; Wei, Zung-Hang

    2016-12-01

    Electrospinning technique is able to create nanofibers with specific orientation. Poly(vinyl alcohol) (PVA) have good mechanical stability but poor cell adhesion property due to the low affinity of protein. In this paper, extracellular matrix, gelatin is incorporated into PVA solution to form electrospun PVA-gelatin nanofibers membrane. Both randomly oriented and aligned nanofibers are used to investigate the topography-induced behavior of fibroblasts. Surface morphology of the fibers is studied by optical microscopy and scanning electron microscopy (SEM) coupled with image analysis. Functional group composition in PVA or PVA-gelatin is investigated by Fourier Transform Infrared (FTIR). The morphological changes, surface coverage, viability and proliferation of fibroblasts influenced by PVA and PVA-gelatin nanofibers with randomly orientated or aligned configuration are systematically compared. Fibroblasts growing on PVA-gelatin fibers show significantly larger projected areas as compared with those cultivated on PVA fibers which p-value is smaller than 0.005. Cells on PVA-gelatin aligned fibers stretch out extensively and their intracellular stress fiber pull nucleus to deform. Results suggest that instead of the anisotropic topology within the scaffold trigger the preferential orientation of cells, the adhesion of cell membrane to gelatin have substantial influence on cellular behavior.

  4. Randomized comparison of surgical stress and the nutritional status between laparoscopy-assisted and open distal gastrectomy for gastric cancer.

    Science.gov (United States)

    Aoyama, Toru; Yoshikawa, Takaki; Hayashi, Tsutomu; Hasegawa, Shinichi; Tsuchida, Kazuhito; Yamada, Takanobu; Cho, Haruhiko; Ogata, Takashi; Fujikawa, Hirohito; Yukawa, Norio; Oshima, Takashi; Rino, Yasushi; Masuda, Munetaka

    2014-06-01

    Laparoscopy-assisted distal gastrectomy (LADG) for gastric cancer may prevent the development of an impaired nutritional status due to reduced surgical stress compared with open distal gastrectomy (ODG). This study was performed as an exploratory analysis of a phase III trial comparing LADG and ODG for stage I gastric cancer during the period between May and December of 2011. All patients received the same perioperative care via fast-track surgery. The level of surgical stress was evaluated based on the white blood cell count and the interleukin-6 (IL-6) level. The nutritional status was measured according to the total body weight, amount of lean body mass, lymphocyte count, and prealbumin level. Twenty-six patients were randomized to receive ODG (13 patients) or LADG (13 patients). The baseline characteristics and surgical outcomes were similar between the two groups. The median IL-6 level increased from 0.8 to 36.3 pg/dl in the ODG group and from 1.5 to 53.3 pg/dl in the LADG group. The median amount of lean body mass decreased from 48.3 to 46.8 kg in the ODG group and from 46.6 to 46.0 kg in the LADG group. There are no significant differences between two groups. The level of surgical stress and the nutritional status were found to be similar between the ODG and LADG groups in a randomized comparison using the same perioperative care of fast-track surgery.

  5. Electrophysiological performance of a bipolar membrane-coated titanium nitride electrode: a randomized comparison of steroid and nonsteroid lead designs.

    Science.gov (United States)

    Wiegand, U K; Zhdanov, A; Stammwitz, E; Crozier, I; Claessens, R J; Meier, J; Bos, R J; Bode, F; Potratz, J

    1999-06-01

    The aim of this multicenter study was to investigate the performance of a new cardiac pacemaker lead with a titanium nitride cathode coated with a copolymer membrane. In particular, the electrophysiological effect of steroid dissolved in this ion-exchange membrane was evaluated by randomized comparison. Ninety-five patients were randomized either to the 1450 T (n = 51) or the 1451 T ventricular lead (n = 45) and received telemeteral VVI(R) pacemakers with identical diagnostic features. Both leads were bipolar, were passively affixed, and had a porous titanium nitride tip with a surface area of 3.5 mm2. The only difference between the two electrodes was 13 micrograms of dexamethasone added to the 1450 Ts membrane coating. Voltage thresholds (VTH) at pulse durations of 0.25, 0.37, and 0.5 ms, lead impedance, and sensing thresholds were measured at discharge, 2 weeks, 1 month, 3 months, and 6 months after implantation. Mean amplitude and the slew rate from three telemetered intracardiac electrograms, chronaxie-rheobase product, and minimum energy consumption were calculated. After a 6-month follow-up, mean voltage thresholds of 0.65 +/- 0.20 V and 0.63 +/- 0.34 were achieved for the 1450 T lead and 1451 T lead, respectively. As a result, a VTH < 1.0 V was obtained in all patients with 1450 T electrodes and in 97.7% of patients with 1451 T leads after 6 months follow-up. In both electrodes, stable VTH was reached 2 weeks after implantation, and no transient rise in threshold was observed. No differences were observed between the steroid and the nonsteroid group in respect to VTH, chronaxie-rheobase product, minimum energy consumption, and potential amplitude and slew rate. In conclusion, safe and efficient pacing at low pulse amplitudes were achieved with both leads. The tip design, independently of the steroid additive, prevented any energy-consuming increases in the voltage threshold.

  6. Comparison of the efficacy of two anesthetic techniques of mandibular primary first molar: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Davood Ghasemi Tudeshchoie

    2013-01-01

    Full Text Available Background: The most common technique to anesthetize mandibular primary teeth is inferior alveolar (I.A nerve block injection which induces a relatively sustained anesthesia and in turn may potentially traumatize soft-tissues. Therefore, the need of having an alternative technique of anesthesia with a shorter term but the same efficacy is reasonable. The aim of this study was a comparison of the efficacy of two anesthetic techniques of mandibular primary first molar. Materials and Methods: In this randomized crossover clinical trial, 40 children with ages ranged from 5 years to 8 years whose mandibular primary first molars were eligible for pulpotomy, were selected and divided randomly into two groups. The right and left mandibular first molars of group A were anesthetized with infiltration and I. A nerve block techniques in the first and second sessions respectively. The left and right mandibular first molars of group B were anesthetized with I.A nerve block and infiltration techniques in the first and second sessions respectively. The severity of pain were measured and recorded according to sound-eye-motor scale by a certain person. Data was analyzed using Wilcoxon Signed Rank and Mann-Whitney U tests (P < 0.05. Results: The severity of pain was lower in infiltration technique versus I.A nerve block. There were no significant differences between the severities of pain on pulpal exposure of two techniques. Conclusion: It seems that infiltration technique is more favorable to anesthetize the mandibular primary first molar compared to I.A nerve block.

  7. Comparison of Intravenous Metoclopramide and Acetaminophen in Primary Headaches: a Randomized Controlled Trial

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    Gholamreza Faridaalaee

    2015-05-01

    Full Text Available Introduction: Headache is the most common neurologic symptom among referees to the emergency department (ED, while the best treatment has not yet been found. Therefore, in the present study pain relief effects of metoclopramide and acetaminophen were compared in patients suffered acute primary headache. Methods: This study was a double-blind randomized clinical trial performed in Imam Khomeini Hospital, Urmia, Iran, through July to October 2014.  All adult patients, with acute primary (migraine, tension type and cluster headache referred to the ED were included in this study. Pain Severity was measured with 10 centimeters numeric rating scales. The patients were randomized in to two groups of intravenous (IV metoclopramide (10 milligrams and acetaminophen (1 gram. Pain score, success rate, and complication of drugs were compared within administration time and 15, 30, 60, as well as 120 minutes after medication. Results: 100 patients were equally categorized in to two groups (mean age of 32 ± 13.2 years; 51.2% male. Initial pain score in metoclopramide and acetaminophen groups were 9.1 and 9.4, respectively (p=0.46. IV metoclopramide did not have any analgesic effect at 15 minutes, but had good effect at 30 minutes. While, the analgesic effect of acetaminophen initiated after 15 minutes. After 2 hours, both drugs had good treatment effect on primary headaches (p<0.001. Conclusion: The present study demonstrated that efficacy of metoclopramide for pain relief in primary headaches is lower than acetaminophen.  In this regard, success rate of acetaminophen was 42.0% versus 0% for metoclopramide within 15 minutes. The efficacy of acetaminophen continued until 60 minutes.

  8. A Randomized Study of Incentivizing HIV Testing for Parolees in Community Aftercare.

    Science.gov (United States)

    Saxena, Preeta; Hall, Elizabeth A; Prendergast, Michael

    2016-04-01

    HIV risk-behaviors are high in criminal justice populations and more efforts are necessary to address them among criminal justice-involved substance abusers. This study examines the role of incentives in promoting HIV testing among parolees. Participants were randomly assigned to either an incentive (n = 104) or education group (control; n = 98), where the incentive group received a voucher for testing for HIV. Bivariate comparisons showed that a larger proportion of those in the incentive group received HIV testing (59% versus 47%), but this was not statistically significant (p = .09). However, in a multivariate logistic regression model controlling for covariates likely to influence HIV-testing behavior, those in the incentive group had increased odds of HIV testing in comparison to those in the education group (OR = 1.99, p testing and other healthy behaviors in criminal justice populations.

  9. Blanket comparison and selection study. Volume I

    International Nuclear Information System (INIS)

    1983-10-01

    The objectives of the Blanket Comparison and Selection Study (BCSS) can be stated as follows: (1) Define a small number (approx. 3) of blanket design concepts that should be the focus of the blanket R and D program. A design concept is defined by the selection of all materials (e.g., breeder, coolant, structure and multiplier) and other major characteristics that significantly influence the R and D requirements. (2) Identify and prioritize the critical issues for the leading blanket concepts. (3) Provide the technical input necessary to develop a blanket R and D program plan. Guidelines for prioritizing the R and D requirements include: (a) critical feasibility issues for the leading blanket concepts will receive the highest priority, and (b) for equally important feasibility issues, higher R and D priority will be given to those that require minimum cost and short time

  10. A Randomized Comparison Between Staple-Line Oversewing Versus No Reinforcement During Laparoscopic Vertical Sleeve Gastrectomy.

    Science.gov (United States)

    Taha, Osama; Abdelaal, Mahmoud; Talaat, Mohamed; Abozeid, Mohamed

    2018-01-01

    Varieties of intraoperative methods such as oversewing of staple lines or other reinforcement products are used for preventing the laparoscopic vertical sleeve gastrectomy (LSG) complications. The aim of this study is to evaluate the complication rates of the gastric stapling alone versus stapling with oversewing invagination of the staple line in the LSG. This is a single-center randomized study, Patients were randomized to two groups, 200 patients underwent LSG without reinforcement of the staple line and 200 patients underwent LSG with oversewing of the staple line. All patients were followed up for 1 year. The data collected prospectively for statistical analysis included demographics, BMI, preoperative comorbidities, operative time, complications, and hospital stay. The overall mean operative age was 33.7 ± 9.4 years and mean BMI was 42.4 ± 4.3 kg/m 2 . Patient baseline characteristics (age, gender, weight, and BMI) and comorbidities were generally a nonsignificant different between the treatment arms. Surgical time was shorter in patients of the nonreinforced group (44.3 ± vs 51.3 ± 4.3 min; p < 0.01) with lower %EWL (73 ± 13.8 vs 80.7 ± 13.6%, p < 0.01). One patient in the nonreinforced group was complicated by gastric leak. The staple-line bleeding rate was significantly lower in patients underwent oversewing of the staple line during LSG (p < 0.05). Oversewing of the staple line during LSG is a nonexpansive and easy method to decrease the incidence and severity of the postoperative bleeding. However, it is time-consuming and should be performed by experienced surgeons to avoid the complications which may occur secondary to the seroserotomy suturing.

  11. Comparison of the commercial color LCD and the medical monochrome LCD using randomized object test patterns.

    Directory of Open Access Journals (Sweden)

    Jay Wu

    Full Text Available Workstations and electronic display devices in a picture archiving and communication system (PACS provide a convenient and efficient platform for medical diagnosis. The performance of display devices has to be verified to ensure that image quality is not degraded. In this study, we designed a set of randomized object test patterns (ROTPs consisting of randomly located spheres with various image characteristics to evaluate the performance of a 2.5 mega-pixel (MP commercial color LCD and a 3 MP diagnostic monochrome LCD in several aspects, including the contrast, resolution, point spread effect, and noise. The ROTPs were then merged into 120 abdominal CT images. Five radiologists were invited to review the CT images, and receiver operating characteristic (ROC analysis was carried out using a five-point rating scale. In the high background patterns of ROTPs, the sensitivity performance was comparable between both monitors in terms of contrast and resolution, whereas, in the low background patterns, the performance of the commercial color LCD was significantly poorer than that of the diagnostic monochrome LCD in all aspects. The average area under the ROC curve (AUC for reviewing abdominal CT images was 0.717±0.0200 and 0.740±0.0195 for the color monitor and the diagnostic monitor, respectively. The observation time (OT was 145±27.6 min and 127±19.3 min, respectively. No significant differences appeared in AUC (p = 0.265 and OT (p = 0.07. The overall results indicate that ROTPs can be implemented as a quality control tool to evaluate the intrinsic characteristics of display devices. Although there is still a gap in technology between different types of LCDs, commercial color LCDs could replace diagnostic monochrome LCDs as a platform for reviewing abdominal CT images after monitor calibration.

  12. Comparison of different anesthesia techniques during esophagogastroduedenoscopy in children: a randomized trial.

    Science.gov (United States)

    Patino, Mario; Glynn, Susan; Soberano, Mark; Putnam, Philip; Hossain, Md Monir; Hoffmann, Clifford; Samuels, Paul; Kibelbek, Michael J; Gunter, Joel

    2015-10-01

    Esophagogastroduedenoscopy (EGD) in children is usually performed under general anesthesia. Anesthetic goals include minimization of airway complications while maximizing operating room (OR) efficiency. Currently, there is no consensus on which anesthetic technique best meets these goals. We performed a prospective randomized study comparing three different anesthetic techniques. To evaluate the incidence of respiratory complications (primary aim) and institutional efficiency (secondary aim) among three different anesthetic techniques in children undergoing EGD. Subjects received a standardized inhalation induction of anesthesia followed by randomization to one of the three groups: Group intubated, sevoflurane (IS), Group intubated, propofol (IP), and Group native airway, nonintubated, propofol (NA). Respiratory complications included minor desaturation (SpO2 between 94% and 85%), severe desaturation (SpO2 < 85%), apnea, airway obstruction/laryngospasm, aspiration, and/or inadequate anesthesia during the endoscopy. Evaluation of institutional efficiency was determined by examining the time spent during the different phases of care (anesthesia preparation, procedure, OR stay, recovery, and total perioperative care). One hundred and seventy-nine children aged 1-12 years (median 7 years; 4.0, 10.0) were enrolled (Group IS N = 60, Group IP N = 59, Group NA N = 61). The incidence of respiratory complications was higher in the Group NA (0.459) vs Group IS (0.033) or Group IP (0.086) (P < 0.0001). The most commonly observed complications were desaturation, inadequate anesthesia, and apnea. There were no differences in institutional efficiency among the three groups. Respiratory complications were more common in Group NA. The use of native airway with propofol maintenance during EGD does not offer advantages with respect to respiratory complications or institutional efficiency. © 2015 John Wiley & Sons Ltd.

  13. Randomized comparison of distal and proximal cerebral protection during carotid artery stenting.

    Science.gov (United States)

    Cano, Manuel N; Kambara, Antônio M; de Cano, Silvia J F; Pezzi Portela, Luiz Antônio; Paes, Ângela Tavares; Costa, J Ribamar; Abizaid, Alexandre Antônio Cunha; Moreira, Samuel Martins; Sousa, Amanda G M R; Sousa, J Eduardo Moraes Rego

    2013-11-01

    This study sought to randomly compare cerebral protection with ANGIOGUARD (Cordis Corporation, Bridgewater, New Jersey) with Mo.Ma (Invatec/Medtronic Vascular Inc, Santa Rosa, California) during carotid artery stenting (CAS), using diffusion-weighted magnetic resonance imaging (DW-MRI) to detect new ischemic cerebral lesions. The number, size, and location of lesions were analyzed. The choice of the type of cerebral protection during CAS is controversial. From July 2008 to July 2011, 60 patients undergoing CAS were randomized to ANGIOGUARD or Mo.Ma, distributed by chance, 30 patients for each group. All patients underwent DW-MRI before and after CAS. An independent neuroradiologist blinded to the cerebral protection used analyzed the images. Univariate and multivariate logistic models were fitted to analyze new ischemic lesions. Alternatively, a propensity score approach was used to reduce the bias due to differences between the groups. For the number of lesions, we used Poisson regression models. New ischemic lesions seen on DW-MRI were present in 63.3% of the ANGIOGUARD group versus 66.7% of the Mo.Ma cohort (p = 0.787). The number of ischemic cerebral lesions per patient, when present, was significantly lower in the Mo.Ma group (a median of 6 lesions per patient vs. a median of 10 in the ANGIOGUARD, p minor stroke during CAS (1.66%). New ischemic lesions seen on DW-MRI were present in both groups in >60%, but the number of lesions per patient was greater in the ANGIOGUARD group. No death or disabling stroke occurred during at least 1 year of follow-up in both cohorts. Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  14. Comparison of Three types of Tooth Brushes on Plaque and Gingival Indices: A Randomized Clinical Trial.

    Science.gov (United States)

    Moeintaghavi, Amir; Sargolzaie, Naser; Rostampour, Mehrnoosh; Sarvari, Sara; Kargozar, Sanaz; Gharaei, Shideh

    2017-01-01

    To compare clinical results of three types of manual tooth brushes on plaque removal efficacy and gingivitis. This study is a single blind randomized trial with crossover design which involved 30 periodontaly healthy individuals. Professional plaque removal and oral hygiene instruction were performed for all the participants in the first step of our study followed by asking them to avoid brushing for 2 days. Thereafter plaque and gingivitis scores were measured using plaque and gingival indices (PI and GI). Then subjects were instructed to use Pulsar tooth brush for a two-week period and then, GI and PI indices were assessed again. After passing one-week period for wash out, subjects didn't brush for 2 days and indices were recorded again. The same procedure was done for CrossAction, and Butler 411 tooth brushes respectively and at the end of the study these variables were analyzed using SPSS software ver.16. Repeated measurement ANOVA test was used to compare the scores between different brushes. Finding of this study reveals that using all three types of tooth brushes resulted in significant plaque and gingivitis reduction compared to baseline levels. Pulsar tooth brush was significantly more effective in diminishing PI and GI than Butler tooth brush (p=0.044 and 0.031 respectively). According to our findings all 3 types of tooth brushes are effective in reduction of plaque and gingivitis and this reduction is significantly greater for Pulsar tooth brush compared to Butler and CrossAction tooth brushes.

  15. A randomized, controlled comparison of home versus institutional rehabilitation of patients with hip fracture.

    Science.gov (United States)

    Kuisma, Raija

    2002-08-01

    To compare ambulation outcomes between home and institutional rehabilitation of patients with hip fracture. Randomized controlled clinical equivalence trial. The Queen Elizabeth Hospital in Hong Kong. Eighty-one patients with hip fracture. Study group patients (40) were discharged directly home from the acute hospital and visited by a physiotherapist an average of 4.6 times. The control group subjects (41) were discharged to a rehabilitation centre for further treatment lasting on average 36.2 days (SD 14.6) and they received physiotherapy daily. Ambulation ability measured on a categorical scale. The mean age of the subjects was 75 years (SD 8.3 years). Females comprised 60% of all the subjects and majority were retired or home makers. Both groups of patients improved in their ambulation ability during their rehabilitation period but neither group achieved their pre-ambulatory status by the time of completion of the study. The study group achieved significantly higher ambulation scores (p institution-based rehabilitation.

  16. MiDAS ENCORE: Randomized Controlled Study Design and Protocol.

    Science.gov (United States)

    Benyamin, Ramsin M; Staats, Peter S

    2015-01-01

    Epidural steroid injections (ESIs) are commonly used for treatment of symptomatic lumbar spinal stenosis (LSS). ESIs are generally administered after failure of conservative therapy. For LSS patients suffering from neurogenic claudication, the mild® procedure provides an alternative to ESIs via minimally invasive lumbar decompression. Both ESIs and mild offer interventional pain treatment options for LSS patients experiencing neurogenic claudication refractory to more conservative therapies. Prospective, multi-center, randomized controlled, clinical study. Twenty-six interventional pain management centers throughout the United States. To compare patient outcomes following treatment with either mild or ESIs in LSS patients with neurogenic claudication and having verified ligamentum flavum hypertrophy. Study participants include Medicare beneficiaries who meet study inclusion/exclusion criteria. Eligible patients will be randomized in a 1:1 ratio to one of 2 treatment arms, mild (treatment group) or ESI (control group). Each study group will include approximately 150 patients who have experienced neurogenic claudication symptoms for ≥ 3 months duration who have failed to respond to physical therapy, home exercise programs, and oral analgesics. Those randomized to mild are prohibited from receiving lumbar ESIs during the study period, while those randomized to ESI may receive ESIs up to 4 times per year. Patient assessments will occur at baseline, 6 months, and one year. An additional assessment will be conducted for the mild patient group at 2 years. The primary efficacy outcome measure is the proportion of Oswestry Disability Index (ODI) responders from baseline to one year follow-up in the treatment group (mild) versus the control group (ESI). ODI responders are defined as those patients achieving the validated Minimal Important Change (MIC) of ≥ 10 point improvement in ODI from baseline to follow-up as a clinically significant efficacy threshold. Secondary

  17. A randomized comparison between costoclavicular and paracoracoid ultrasound-guided infraclavicular block for upper limb surgery.

    Science.gov (United States)

    Leurcharusmee, Prangmalee; Elgueta, Maria Francisca; Tiyaprasertkul, Worakamol; Sotthisopha, Thitipan; Samerchua, Artid; Gordon, Aida; Aliste, Julian; Finlayson, Roderick J; Tran, De Q H

    2017-06-01

    This two-centre randomized trial compared costoclavicular and paracoracoid ultrasound-guided infraclavicular brachial plexus block in patients undergoing upper limb surgery. We hypothesized that both techniques would result in similar onset times and designed the study as an equivalence trial. Ninety patients undergoing upper limb surgery at or distal to the elbow were randomly allocated to receive a costoclavicular (n = 45) or paracoracoid (n = 45) ultrasound-guided infraclavicular brachial plexus block. Both groups received a 35-mL mixture of 1% lidocaine-0.25% bupivacaine with epinephrine 5 µg·mL -1 . In the costoclavicular group, local anesthetic was injected into the costoclavicular space in the middle of the three cords of the brachial plexus. In the paracoracoid group, local anesthetic was deposited dorsal to the axillary artery in the lateral infraclavicular fossa. A blinded observer recorded the block onset time (primary endpoint), success rate (i.e., surgical anesthesia), block-related pain scores, as well as the incidence of hemidiaphragmatic paralysis. Performance time and the number of needle passes were also recorded during the performance of the block. The total anesthesia-related time was defined as the sum of the performance and onset times. The mean (SD) onset times were comparable between the costoclavicular and paracoracoid groups [16.0 (7.5) min vs 16.8 (6.2) min, respectively; mean difference, 0.8; 95% confidence interval, -2.3 to 3.8; P = 0.61]. Furthermore, no intergroup differences were found in terms of performance time (P = 0.09), total anesthesia-related time (P = 0.90), surgical anesthesia (P > 0.99), and hemidiaphragmatic paralysis (P > 0.99). The paracoracoid technique required marginally fewer median [interquartile range] needle passes than the costoclavicular technique (2 [1-4] vs 2 [1-6], respectively; P = 0.048); however, procedural pain was comparable between the two study groups. Costoclavicular and paracoracoid ultrasound

  18. Comparison of Batch Assay and Random Assay Using Automatic Dispenser in Radioimmunoassay

    Energy Technology Data Exchange (ETDEWEB)

    Moon, Seung Hwan; Jang, Su Jin; Kang, Ji Yeon; Lee, Dong Soo; Chung, June Key; Lee, Myung Chul [Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul (Korea, Republic of); Lee, Ho Young; Shin, Sun Young; Min, Gyeong Sun; Lee, Hyun Joo [Seoul National University college of Medicine, Seoul (Korea, Republic of)

    2009-08-15

    Radioimmunoassay (RIA) was usually performed by the batch assay. To improve the efficiency of RIA without increase of the cost and time, random assay could be a choice. We investigated the possibility of the random assay using automatic dispenser by assessing the agreement between batch assay and random assay. The experiments were performed with four items; Triiodothyronine (T3), free thyroxine (fT4), Prostate specific antigen (PSA), Carcinoembryonic antigen (CEA). In each item, the sera of twenty patients, the standard, and the control samples were used. The measurements were done 4 times with 3 hour time intervals by random assay and batch assay. The coefficient of variation (CV) of the standard samples and patients' data in T3, fT4, PSA, and CEA were assessed. ICC (Intraclass correlation coefficient) and coefficient of correlation were measured to assessing the agreement between two methods. The CVs (%) of T3, fT4, PSA, and CEA measured by batch assay were 3.2+-1.7%, 3.9+-2.1%, 7.1+-6.2%, 11.2+-7.2%. The CVs by random assay were 2.1+-1.7%, 4.8+-3.1%, 3.6+-4.8%, and 7.4+-6.2%. The ICC between the batch assay and random assay were 0.9968 (T3), 0.9973 (fT4), 0.9996 (PSA), and 0.9901 (CEA). The coefficient of correlation between the batch assay and random assay were 0.9924(T3), 0.9974 (fT4), 0.9994 (PSA), and 0.9989 (CEA) (p<0.05). The results of random assay showed strong agreement with the batch assay in a day. These results suggest that random assay using automatic dispenser could be used in radioimmunoassay

  19. Comparison of Batch Assay and Random Assay Using Automatic Dispenser in Radioimmunoassay

    International Nuclear Information System (INIS)

    Moon, Seung Hwan; Jang, Su Jin; Kang, Ji Yeon; Lee, Dong Soo; Chung, June Key; Lee, Myung Chul; Lee, Ho Young; Shin, Sun Young; Min, Gyeong Sun; Lee, Hyun Joo

    2009-01-01

    Radioimmunoassay (RIA) was usually performed by the batch assay. To improve the efficiency of RIA without increase of the cost and time, random assay could be a choice. We investigated the possibility of the random assay using automatic dispenser by assessing the agreement between batch assay and random assay. The experiments were performed with four items; Triiodothyronine (T3), free thyroxine (fT4), Prostate specific antigen (PSA), Carcinoembryonic antigen (CEA). In each item, the sera of twenty patients, the standard, and the control samples were used. The measurements were done 4 times with 3 hour time intervals by random assay and batch assay. The coefficient of variation (CV) of the standard samples and patients' data in T3, fT4, PSA, and CEA were assessed. ICC (Intraclass correlation coefficient) and coefficient of correlation were measured to assessing the agreement between two methods. The CVs (%) of T3, fT4, PSA, and CEA measured by batch assay were 3.2±1.7%, 3.9±2.1%, 7.1±6.2%, 11.2±7.2%. The CVs by random assay were 2.1±1.7%, 4.8±3.1%, 3.6±4.8%, and 7.4±6.2%. The ICC between the batch assay and random assay were 0.9968 (T3), 0.9973 (fT4), 0.9996 (PSA), and 0.9901 (CEA). The coefficient of correlation between the batch assay and random assay were 0.9924(T3), 0.9974 (fT4), 0.9994 (PSA), and 0.9989 (CEA) (p<0.05). The results of random assay showed strong agreement with the batch assay in a day. These results suggest that random assay using automatic dispenser could be used in radioimmunoassay

  20. COMPARISON OF ASTYM THERAPY AND KINESIOTAPING FOR ROTATOR CUFF TENDINOPATHY IN DIABETIC PATIENTS: RANDOMIZED CONTROLLED TRIAL

    Directory of Open Access Journals (Sweden)

    Azza Atya

    2017-09-01

    Full Text Available Background: Rotator cuff tendinopathy is a significant problem among diabetics that frequently restricts patient’s activity in terms of pain and disability. The purpose of this study was to compare between the effect of Astym therapy and kinesiotaping in treating diabetic patients with chronic rotator cuff tendinopathy. Methods: 56 diabetic patients diagnosed with chronic rotator cuff tendinopathy were randomly assigned into Astym therapy group (n=28 or kinesiotaping group (n= 28. All patients received conventional program in addition to Astym treatment or Kinesiotaping for 24 sessions (2times/week. Patients were assessed at baseline and at the end of corresponding intervention with visual analogy scale (VAS for pain intensity, shoulder disability questioner (SDQ for shoulder disability, and electrogoniometer for shoulder range of motion. Results: For the 56 study participants (21 males and 35 females; mean age=41.9±6.9 years there were significant differences in all measuring outcomes in both group when compared to baseline measurements (p 0.05. Conclusion: kinesiotaping appears to be more effective than Astym therapy in reducing pain for diabetic patients with chronic rotator cuff tendinopathy.

  1. A randomized controlled comparison of electroconvulsive therapy and repetitive transcranial magnetic stimulation in severe and resistant nonpsychotic major depression.

    Science.gov (United States)

    Grunhaus, Leon; Schreiber, Shaul; Dolberg, Ornah T; Polak, Dana; Dannon, Pinhas N

    2003-02-15

    Studies published over the past few years suggest that transcranial magnetic stimulation (TMS) may have significant antidepressant actions. In a previous report, we compared electroconvulsive therapy (ECT) and repetitive TMS (rTMS) and found ECT to be superior for psychotic major depression (MD); however, ECT and rTMS had similar results in nonpsychotic MD. We now report on a controlled randomized comparison of ECT and rTMS in patients with nonpsychotic MD. Forty patients with nonpsychotic MD referred for ECT were included. Electroconvulsive therapy was performed according to established protocols. Repetitive TMS was performed over the left dorsolateral prefrontal cortex at 90% motor threshold. Patients were treated with 20 sessions (five times per week for 4 weeks) of 10-Hz treatments (1200 pulses per treatment-day) at 90% motor threshold. Response to treatment was defined as a decrease of at least 50% in the Hamilton Rating Scale for Depression (HRSD) score, with a final HRSD equal or less than 10 points and a final Global Assessment of Function Scale rating of 60 or more points. The overall response rate was 58% (23 out of 40 patients responded to treatment). In the ECT group, 12 responded and eight did not; in the rTMS group, 11 responded and nine did not (chi2 =.10, ns). Thus, patients responded as well to either ECT or rTMS. This study adds to the growing literature supporting an antidepressant effect for rTMS. This study is particularly relevant because it suggests that rTMS and ECT reach similar results in nonpsychotic major depressive disorder.

  2. The effects of improvisational music therapy on joint attention behaviors in autistic children: A randomized controlled study

    DEFF Research Database (Denmark)

    Kim, Jinah; Wigram, Tony; Gold, Christian

    2008-01-01

    The purpose of this study was to investigate the effects of improvisational music therapy on joint attention behaviors in pre-school children with autism. It was a randomized controlled study employing a single subject comparison design in two different conditions, improvisational music therapy a...... skills in children than play. Session analysis showed significantly more and lengthier events of eye contact and turn-taking in improvisational music therapy than play sessions. The implications of these findings are discussed further....

  3. Managing mobility outcomes in vulnerable seniors ( MMOVeS): a randomized controlled pilot study.

    Science.gov (United States)

    Figueiredo, Sabrina; Morais, Jose A; Mayo, Nancy

    2017-12-01

    To estimate feasibility and potential for efficacy of an individualized, exercise-focused, self-management program (i.e. Managing Mobility Outcomes In Vulnerable Seniors ( MMOVeS)), in comparison to exercise information in improving mobility after six months among seniors recently discharged from hospital. Randomized pilot study. Two McGill University-teaching hospitals. Community dwelling seniors, aged 70 years and older, recently discharged from either participating hospitals. The physiotherapy-facilitated intervention consisted of (1) evaluation of mobility capacity, (2) setting short- and long-term goals, (3) delineation of an exercise treatment plan, (4) an educational booklet to enhance mobility self-management skills, and (5) six monthly telephone calls. Control group received a booklet with information on exercises targeting mobility limitations in seniors. Mobility, pain, and health status were assessed at baseline and at six months using multiple indicators drawn from Disabilities of the Arm, Shoulder, and Hand (DASH) Score, Lower Extremity Functional Scale (LEFS) and Short-Form (SF)-36. In all, 26 people were randomized to the intervention (mean age: 81 ± 8; 39% women), and 23 were randomized to the control (mean age: 79 ± 7; 33% women). The odds ratio for the mobility outcomes combined was 3.08 and the 95% confidence interval excluded 1 (1.65-5.77). The odds ratio for pain and health perception favored the MMOVeS group, but the 95% confidence interval included the null value. This feasibility study highlights the potential for efficacy of an individualized, exercise-focused, self-management program in comparison to exercise information in improving mobility outcome for seniors. Furthermore, a home-program combining self-management skills and exercise taught with minimal supervision prove to be feasible. Finally, data from this study can be used to estimate sample size for a confirmatory trial.

  4. A Comparison of Three Random Number Generators for Aircraft Dynamic Modeling Applications

    Science.gov (United States)

    Grauer, Jared A.

    2017-01-01

    Three random number generators, which produce Gaussian white noise sequences, were compared to assess their suitability in aircraft dynamic modeling applications. The first generator considered was the MATLAB (registered) implementation of the Mersenne-Twister algorithm. The second generator was a website called Random.org, which processes atmospheric noise measured using radios to create the random numbers. The third generator was based on synthesis of the Fourier series, where the random number sequences are constructed from prescribed amplitude and phase spectra. A total of 200 sequences, each having 601 random numbers, for each generator were collected and analyzed in terms of the mean, variance, normality, autocorrelation, and power spectral density. These sequences were then applied to two problems in aircraft dynamic modeling, namely estimating stability and control derivatives from simulated onboard sensor data, and simulating flight in atmospheric turbulence. In general, each random number generator had good performance and is well-suited for aircraft dynamic modeling applications. Specific strengths and weaknesses of each generator are discussed. For Monte Carlo simulation, the Fourier synthesis method is recommended because it most accurately and consistently approximated Gaussian white noise and can be implemented with reasonable computational effort.

  5. Comparison of Random Forest and Support Vector Machine classifiers using UAV remote sensing imagery

    Science.gov (United States)

    Piragnolo, Marco; Masiero, Andrea; Pirotti, Francesco

    2017-04-01

    Since recent years surveying with unmanned aerial vehicles (UAV) is getting a great amount of attention due to decreasing costs, higher precision and flexibility of usage. UAVs have been applied for geomorphological investigations, forestry, precision agriculture, cultural heritage assessment and for archaeological purposes. It can be used for land use and land cover classification (LULC). In literature, there are two main types of approaches for classification of remote sensing imagery: pixel-based and object-based. On one hand, pixel-based approach mostly uses training areas to define classes and respective spectral signatures. On the other hand, object-based classification considers pixels, scale, spatial information and texture information for creating homogeneous objects. Machine learning methods have been applied successfully for classification, and their use is increasing due to the availability of faster computing capabilities. The methods learn and train the model from previous computation. Two machine learning methods which have given good results in previous investigations are Random Forest (RF) and Support Vector Machine (SVM). The goal of this work is to compare RF and SVM methods for classifying LULC using images collected with a fixed wing UAV. The processing chain regarding classification uses packages in R, an open source scripting language for data analysis, which provides all necessary algorithms. The imagery was acquired and processed in November 2015 with cameras providing information over the red, blue, green and near infrared wavelength reflectivity over a testing area in the campus of Agripolis, in Italy. Images were elaborated and ortho-rectified through Agisoft Photoscan. The ortho-rectified image is the full data set, and the test set is derived from partial sub-setting of the full data set. Different tests have been carried out, using a percentage from 2 % to 20 % of the total. Ten training sets and ten validation sets are obtained from

  6. Randomized comparison of vaginal self-sampling by standard vs. dry swabs for Human papillomavirus testing

    International Nuclear Information System (INIS)

    Eperon, Isabelle; Vassilakos, Pierre; Navarria, Isabelle; Menoud, Pierre-Alain; Gauthier, Aude; Pache, Jean-Claude; Boulvain, Michel; Untiet, Sarah; Petignat, Patrick

    2013-01-01

    To evaluate if human papillomavirus (HPV) self-sampling (Self-HPV) using a dry vaginal swab is a valid alternative for HPV testing. Women attending colposcopy clinic were recruited to collect two consecutive Self-HPV samples: a Self-HPV using a dry swab (S-DRY) and a Self-HPV using a standard wet transport medium (S-WET). These samples were analyzed for HPV using real time PCR (Roche Cobas). Participants were randomized to determine the order of the tests. Questionnaires assessing preferences and acceptability for both tests were conducted. Subsequently, women were invited for colposcopic examination; a physician collected a cervical sample (physician-sampling) with a broom-type device and placed it into a liquid-based cytology medium. Specimens were then processed for the production of cytology slides and a Hybrid Capture HPV DNA test (Qiagen) was performed from the residual liquid. Biopsies were performed if indicated. Unweighted kappa statistics (κ) and McNemar tests were used to measure the agreement among the sampling methods. A total of 120 women were randomized. Overall HPV prevalence was 68.7% (95% Confidence Interval (CI) 59.3–77.2) by S-WET, 54.4% (95% CI 44.8–63.9) by S-DRY and 53.8% (95% CI 43.8–63.7) by HC. Among paired samples (S-WET and S-DRY), the overall agreement was good (85.7%; 95% CI 77.8–91.6) and the κ was substantial (0.70; 95% CI 0.57-0.70). The proportion of positive type-specific HPV agreement was also good (77.3%; 95% CI 68.2-84.9). No differences in sensitivity for cervical intraepithelial neoplasia grade one (CIN1) or worse between the two Self-HPV tests were observed. Women reported the two Self-HPV tests as highly acceptable. Self-HPV using dry swab transfer does not appear to compromise specimen integrity. Further study in a large screening population is needed. ClinicalTrials.gov: http://clinicaltrials.gov/show/NCT01316120

  7. Peer-facilitated cognitive dissonance versus healthy weight eating disorders prevention: A randomized comparison.

    Science.gov (United States)

    Becker, Carolyn Black; Wilson, Chantale; Williams, Allison; Kelly, Mackenzie; McDaniel, Leda; Elmquist, Joanna

    2010-09-01

    Research supports the efficacy of both cognitive dissonance (CD) and healthy weight (HW) eating disorders prevention, and indicates that CD can be delivered by peer-facilitators, which facilitates dissemination. This study investigated if peer-facilitators can deliver HW when it is modified for their use and extended follow-up of peer-facilitated CD as compared to previous trials. Based on pilot data, we modified HW (MHW) to facilitate peer delivery, elaborate benefits of the healthy-ideal, and place greater emphasis on consuming nutrient dense foods. Female sorority members (N=106) were randomized to either two 2-h sessions of CD or MHW. Participants completed assessment pre- and post-intervention, and at 8-week, 8-month, and 14-month follow-up. Consistent with hypotheses, CD decreased negative affect, thin-ideal internalization, and bulimic pathology to a greater degree post-intervention. Both CD and MHW reduced negative affect, internalization, body dissatisfaction, dietary restraint, and bulimic pathology at 14 months. Copyright © 2010 Elsevier Ltd. All rights reserved.

  8. [Comparison of two antimicrobial prophylaxis regimens in biliary tract surgery: a randomized controlled clinical trial].

    Science.gov (United States)

    Orozco, H; Sifuentes Osornio, J; Prado, E; Takahashi, T; López Graniel, C M; Anaya, E; Canto, J

    1993-01-01

    The aim of this study was to analyze the efficacy in prophylaxis during biliary tract and gallbladder surgery with amoxicillin/clavulanate and to compare it with the combination of cephalothin and clindamycin. A randomized nonblinded clinical trial with a blind independent observer. Tertiary-care center. Forty-two patients were included. All had undergone biliary tract and/or gallbladder surgery. They were divided in two groups: 22 in group A (cephalothin and clindamycin), and 20 in group B (amoxicillin/clavulanate). Patients from group A were intravenously treated with three doses of cephalothin (2 g at anesthetic induction and two additional doses of 1 g at six-hour intervals), and three of clindamycin (600 mg every six hours). Patients from group B received three doses of amoxicillin/clavulanate (1000/200 mg IV, one during the induction of the anesthesia followed by two more at six-hour intervals). In group A six wound infections were recorded, one of them with secondary bacteremia. In group B we did not record any infection (Fisher p clindamycin.

  9. Anesthesia machine checkout and room setup: a randomized, single-blind, comparison of two teaching modalities.

    Science.gov (United States)

    Spofford, Christina M; Bayman, Emine O; Szeluga, Debra J; From, Robert P

    2012-01-01

    Novel methods for teaching are needed to enhance the efficiency of academic anesthesia departments as well as provide approaches to learning that are aligned with current trends and advances in technology. A video was produced that taught the key elements of anesthesia machine checkout and room set up. Novice learners were randomly assigned to receive either the new video format or traditional lecture-based format for this topic during their regularly scheduled lecture series. Primary outcome was the difference in written examination score before and after teaching between the two groups. Secondary outcome was the satisfaction score of the trainees in the two groups. Forty-two students assigned to the video group and 36 students assigned to the lecture group completed the study. Students in each group similar interest in anesthesia, pre-test scores, post-test scores, and final exam scores. The median posttest to pretest difference was greater in the video groups (3.5 (3.0-5.0) vs 2.5 (2.0-3.0), for video and lecture groups respectively, p 0.002). Despite improved test scores, students reported higher satisfaction the traditional, lecture-based format (22.0 (18.0-24.0) vs 24.0 (20.0-28.0), for video and lecture groups respectively, p students in the video-based teaching group, however students rated traditional, live lectures higher than newer video-based teaching.

  10. Address-based versus random-digit-dial surveys: comparison of key health and risk indicators.

    Science.gov (United States)

    Link, Michael W; Battaglia, Michael P; Frankel, Martin R; Osborn, Larry; Mokdad, Ali H

    2006-11-15

    Use of random-digit dialing (RDD) for conducting health surveys is increasingly problematic because of declining participation rates and eroding frame coverage. Alternative survey modes and sampling frames may improve response rates and increase the validity of survey estimates. In a 2005 pilot study conducted in six states as part of the Behavioral Risk Factor Surveillance System, the authors administered a mail survey to selected household members sampled from addresses in a US Postal Service database. The authors compared estimates based on data from the completed mail surveys (n = 3,010) with those from the Behavioral Risk Factor Surveillance System telephone surveys (n = 18,780). The mail survey data appeared reasonably complete, and estimates based on data from the two survey modes were largely equivalent. Differences found, such as differences in the estimated prevalences of binge drinking (mail = 20.3%, telephone = 13.1%) or behaviors linked to human immunodeficiency virus transmission (mail = 7.1%, telephone = 4.2%), were consistent with previous research showing that, for questions about sensitive behaviors, self-administered surveys generally produce higher estimates than interviewer-administered surveys. The mail survey also provided access to cell-phone-only households and households without telephones, which cannot be reached by means of standard RDD surveys.

  11. Comparison of media literacy and usual education to prevent tobacco use: a cluster-randomized trial.

    Science.gov (United States)

    Primack, Brian A; Douglas, Erika L; Land, Stephanie R; Miller, Elizabeth; Fine, Michael J

    2014-02-01

    Media literacy programs have shown potential for reduction of adolescent tobacco use. We aimed to determine if an anti-smoking media literacy curriculum improves students' media literacy and affects factors related to adolescent smoking. We recruited 1170 9th-grade students from 64 classrooms in 3 public urban high schools. Students were randomized by classroom to a media literacy curriculum versus a standard educational program. In an intent-to-treat analysis, we used multilevel modeling to determine if changes in study outcomes were associated with the curricular intervention, controlling for baseline student covariates and the clustering of students within classrooms. Among participants, mean age was 14.5 years and 51% were male, with no significant differences in baseline characteristics between groups. Smoking media literacy changed more among intervention participants compared with control participants (0.24 vs. 0.08, p media literacy curriculum is more effective than a standard educational program in teaching media literacy and improving perceptions of the true prevalence of smoking among adolescents. © 2014, American School Health Association.

  12. Triatoma dimidiata infestation in Chagas disease endemic regions of Guatemala: comparison of random and targeted cross-sectional surveys.

    Directory of Open Access Journals (Sweden)

    Raymond J King

    approximately 0.64 in the targeted surveys in both regions. Sensitivity did not differ between surveys, but the positive predictive value was significantly greater in the random surveys. CONCLUSIONS/SIGNIFICANCE: Surprisingly, targeted surveys were not more effective at determining T. dimidiata prevalence or at directing control to high risk villages in comparison to random surveys. We recommend that random surveys should be selected over targeted surveys whenever possible, particularly when the focus is on directing disease control and elimination and when risk factor association has not been evaluated for all regions under investigation.

  13. Comparison of Intravenous Morphine Versus Paracetamol in Sciatica: A Randomized Placebo Controlled Trial.

    Science.gov (United States)

    Serinken, Mustafa; Eken, Cenker; Gungor, Faruk; Emet, Mucahit; Al, Behcet

    2016-06-01

    The objective was to compare intravenous morphine and intravenous acetaminophen (paracetamol) for pain treatment in patients presenting to the emergency department with sciatica. Patients, between the ages of 21 and 65 years, suffering from pain in the sciatic nerve distribution and a positive straight leg-raise test composed the study population. Study patients were assigned to one of three intravenous interventions: morphine (0.1 mg/kg), acetaminophen (1 g), or placebo. Physicians, nurses, and patients were blinded to the study drug. Changes in pain intensity were measured at 15 and 30 minutes using a visual analog scale. Rescue drug (fentanyl) use and adverse effects were also recorded. Three-hundred patients were randomized. The median change in pain intensity between treatment arms at 30 minutes were as follows: morphine versus acetaminophen 25 mm (95% confidence interval [CI] = 20 to 29 mm), morphine versus placebo 41 mm (95% CI = 37 to 45 mm), and acetaminophen versus placebo 16 mm (95% CI = 12 to 20 mm). Eighty percent of the patients in the placebo group (95% CI = 63.0% to 99%), 18% of the patients in the acetaminophen group (95% CI = 10.7% to 28.5%), and 6% of those in the morphine group (95% CI = 2.0% to 13.2%) required a rescue drug. Adverse effects were similar between the morphine and acetaminophen groups. Morphine and acetaminophen are both effective for treating sciatica at 30 minutes. However, morphine is superior to acetaminophen. © 2016 by the Society for Academic Emergency Medicine.

  14. Randomized Comparison of Helmet CPAP Versus High-Flow Nasal Cannula Oxygen in Pediatric Respiratory Distress.

    Science.gov (United States)

    Vitaliti, Giovanna; Vitaliti, Maria Concetta; Finocchiaro, Maria Carla; Di Stefano, Vita Antonella; Pavone, Piero; Matin, Nassim; Motamed-Gorji, Nazgol; Lubrano, Riccardo; Falsaperla, Raffaele

    2017-08-01

    The current study aimed to compare the efficacy and safety of 2 noninvasive respiratory support methods, which included helmet CPAP and high-flow nasal cannula (HFNC) in children with respiratory distress admitted to a pediatric intermediate care unit. This study was a prospective observational study conducted on children with respiratory distress (age 1-24 months) who were admitted to our acute and emergency operative unit. All included subjects were randomly treated with helmet CPAP or HFNC in a 1:1 fashion until their clinical picture, oxygen saturation, and arterial blood gas (ABG) parameters resolved. The efficiencies of helmet CPAP and HFNC were evaluated by breathing frequency, S pO 2 , ABG pH, ABG P aCO 2 , ABG P aO 2 , and P aO 2 /F IO 2 , recorded once at baseline and then after 1 and 6 h of treatment. Both noninvasive respiratory support modalities were compared with a control group of subjects with respiratory distress under standard therapeutic pharmaceutical protocols. We found that both helmet CPAP and HFNC were efficient in improving the clinical conditions of subjects with mild-to-moderate respiratory distress, although clinical response to helmet CPAP was more efficient and rapid compared with HFNC. Children who received respiratory support had a better clinical course in terms of hospitalization, days of intravenous rehydration therapy, and days of drug administration compared with the control group ( P CPAP and HFNC in respiratory distress resolution in a pediatric intermediate care setting. It aims to identify the most efficient treatment to avoid pediatric ICU admissions and endotracheal intubation and reduce the administration of drugs and days of hospitalization. Copyright © 2017 by Daedalus Enterprises.

  15. Comparison of four techniques of nasogastric tube insertion in anaesthetised, intubated patients: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Mohan Chandra Mandal

    2014-01-01

    Full Text Available Background and Aims: Insertion of nasogastric tubes (NGTs in anaesthetised, intubated patients with a conventional method is sometimes difficult. Different techniques of NGT insertion have been tried with varying degree of success. The aim of this prospective, randomised, open-label study was to evaluate three modified techniques of NGT insertion comparing with the conventional method in respect of success rate, time taken for insertion and the adverse events. Methods: In the operation theatre of general surgery, the patients were randomly allocated into four groups: Group C (control group, n = 54, Group W (ureteral guide wire group, n = 54, Group F (neck flexion with lateral pressure, n = 54 and Group R (reverse Sellick′s manoeuvre, n = 54. The number of attempts for successful NGT insertion, time taken for insertion and adverse events were noted. Results: All the three modified techniques were found more successful than the conventional method on the first attempt. The least time taken for insertion was noted in the reverse Sellick′s method. However, on intergroup analysis, neck flexion and reverse Sellick′s methods were comparable but significantly faster than the other two methods with respect to time taken for insertion. Conclusion: Reverse Sellick′s manoeuver, neck flexion with lateral neck pressure and guide wire-assisted techniques are all better alternatives to the conventional method for successful, quick and reliable NGT insertion with permissible adverse events in anaesthetised, intubated adult patients. Further studies after eliminating major limitations of the present study are warranted to establish the superiority of any one of these modified techniques.

  16. Stochastic spectral Galerkin and collocation methods for PDEs with random coefficients: A numerical comparison

    KAUST Repository

    Bä ck, Joakim; Nobile, Fabio; Tamellini, Lorenzo; Tempone, Raul

    2010-01-01

    Much attention has recently been devoted to the development of Stochastic Galerkin (SG) and Stochastic Collocation (SC) methods for uncertainty quantification. An open and relevant research topic is the comparison of these two methods

  17. Gaming and Conventional Exercises for Improvement of Arm Function After Stroke: A Randomized Controlled Pilot Study.

    Science.gov (United States)

    Kottink, Anke I R; Prange, Gerdienke B; Krabben, Thijs; Rietman, Johan S; Buurke, Jaap H

    2014-06-01

    The use of new technologies in rehabilitation, such as virtual reality and/or computerized gaming exercises, may be useful to enable patients to practice intensively in a motivating way. The objective of the present randomized controlled pilot study was to compare the effect of reach training using a target group specific-designed rehabilitation game to time-matched standardized conventional reach training on arm function after stroke. Twenty chronic stroke patients were randomized to either the rehabilitation game group or the conventional training group. Both groups received three arm training sessions of 30 minutes each week, during a period of 6 weeks. Arm (the upper extremity part of Fugl-Meyer [FM] assessment) and hand (the Action Research Arm [ARA] test) functions were tested 1 week before (T0) and 1 week after (T1) training. A follow-up measurement was performed at 1 month after T1 (T2). ARA and FM scores improved significantly within both groups. Post hoc comparisons revealed significant increases in test scores between T0 and T1 and between T0 and T2 for both ARA and FM, but not for changes from T1 to T2. There were no significant differences between both groups for either clinical test. The present randomized controlled pilot study showed that both arm and hand function improved as much after training with a rehabilitation game as after time-matched conventional training.

  18. Coagulation, inflammatory, and stress responses in a randomized comparison of open and laparoscopic repair of recurrent inguinal hernia

    DEFF Research Database (Denmark)

    Rahr, H B; Bendix, J; Ahlburg, P

    2006-01-01

    BACKGROUND: In previous comparisons of inflammatory and stress responses to open (OR) and laparoscopic (LR) hernia repair, all operations were performed under general anesthesia. Since local anesthesia is widely used for OR, a comparison of this approach with LR seemed relevant. METHODS: Patients...... with recurrent inguinal hernia were randomized to OR under local anesthesia (n = 30) or LR under general anesthesia (n = 31). The magnitude of the surgical trauma was assessed by measuring markers of coagulation (prothrombin fragment 1 + 2), endothelial activation (von Willebrand factor), inflammation...... [leukocytes, interleukin-6, -8 and -10, granulocyte macrophage colony-stimulating factor, and C-reactive protein (CRP)], and endocrine stress (cortisol) in blood collected before operation, 4 h postincision, and on postoperative day 2. RESULTS: Leukocyte counts and interleukin-6 and CRP levels increased...

  19. An open-label, non-randomized comparison of venlafaxine and gabapentin as monotherapy or adjuvant therapy in the management of neuropathic pain in patients with peripheral neuropathy

    Directory of Open Access Journals (Sweden)

    William Eardley

    2010-04-01

    Full Text Available William Eardley, Cory TothDepartment of Clinical Neurosciences and the University of Calgary, Calgary, AB, CanadaAbstract: Although many therapies are used in the management of neuropathic pain (NeP due to polyneuropathy (PN, few comparison studies exist. We performed a prospective, non-randomized, unblended, efficacy comparison of the serotonin-norepinephrine reuptake inhibitor venlafaxine, as either monotherapy or adjuvant therapy, with a first-line medication for NeP, gabapentin, in patients with PN-related NeP. VAS pain scores were assessed after 3 and 6 months in intervention groups and in a cohort of patients receiving no pharmacotherapy. In a total of 223 patients, we analyzed pain quantity and quality (visual analogue scale [VAS] score, Brief Pain Inventory [BPI], quality of life and health status measures [EuroQol 5 Domains, EQ-5D], Medical Outcomes Sleep Study Scale [MOSSS], Hospital Anxiety and Depression Scale [HADS] and Short Form 36 Health Survey [SF-36] after 6 months of therapy. Significant improvements in VAS pain scores occurred for all treatment groups after 6 months. Improvements in aspects of daily life and anxiety were identified in all treatment groups. Our data suggest that monotherapy or adjuvant therapy with venlafaxine is comparable to gabapentin for NeP management. We advocate for head-to-head, randomized, double-blinded studies of current NeP therapies.Keywords: peripheral neuropathy, neuropathic pain, pharmacotherapy, venlafaxine, gabapentin

  20. Genome Wide Association Study to predict severe asthma exacerbations in children using random forests classifiers

    Directory of Open Access Journals (Sweden)

    Litonjua Augusto A

    2011-06-01

    Full Text Available Abstract Background Personalized health-care promises tailored health-care solutions to individual patients based on their genetic background and/or environmental exposure history. To date, disease prediction has been based on a few environmental factors and/or single nucleotide polymorphisms (SNPs, while complex diseases are usually affected by many genetic and environmental factors with each factor contributing a small portion to the outcome. We hypothesized that the use of random forests classifiers to select SNPs would result in an improved predictive model of asthma exacerbations. We tested this hypothesis in a population of childhood asthmatics. Methods In this study, using emergency room visits or hospitalizations as the definition of a severe asthma exacerbation, we first identified a list of top Genome Wide Association Study (GWAS SNPs ranked by Random Forests (RF importance score for the CAMP (Childhood Asthma Management Program population of 127 exacerbation cases and 290 non-exacerbation controls. We predict severe asthma exacerbations using the top 10 to 320 SNPs together with age, sex, pre-bronchodilator FEV1 percentage predicted, and treatment group. Results Testing in an independent set of the CAMP population shows that severe asthma exacerbations can be predicted with an Area Under the Curve (AUC = 0.66 with 160-320 SNPs in comparison to an AUC score of 0.57 with 10 SNPs. Using the clinical traits alone yielded AUC score of 0.54, suggesting the phenotype is affected by genetic as well as environmental factors. Conclusions Our study shows that a random forests algorithm can effectively extract and use the information contained in a small number of samples. Random forests, and other machine learning tools, can be used with GWAS studies to integrate large numbers of predictors simultaneously.

  1. Prospective randomized comparison of mitomycin C application in endoscopic and external dacryocystorhinostomy.

    Science.gov (United States)

    Mudhol, Rekha R; Zingade, N D; Mudhol, R S; Harugop, Anil S; Das, Amal T

    2013-08-01

    The aim of the study is to compare the subjective (relief of symptoms) and objective (endoscopic visualization of ostium patency at the time of syringing) outcomes at the end of two procedures-Endonasal DCR versus External DCR with Mitomycin C and to assess the role of Mitomycin C in maintaining patency of nasolacrimal drainage system. Prospective randomized comparative study was performed. Thirty-five patients were enrolled in each endoscopic and external dacryocystorhinostomy groups with Mitomycin C (MMC) application. The 37 eyes underwent endonasal DCR (28 unilateral primary eyes + 1 bilateral primary eyes + 5 unilateral revision eyes + 1 bilateral revision eye) while 35 eyes underwent external DCR (34 unilateral primary eyes + 1 unilateral revision eye). Mitomycin C 0.2 mg/ml was applied intra-operatively for 5 min to the ostium site at the end of endonasal or external DCR procedure. Objective assessment by syringing at the end of 1 year in the endonasal group showed 35 eyes (94%) were patent, 1 (3%) was partially blocked and 1(3%) was completely blocked; while in external group all 35 eyes (100%) were patent. Endoscopic visualization of the ostium at the time of syringing showed only one eye (3%) in the endonasal group was blocked while all the other eyes in both groups were patent. Both groups had a mean follow-up of 6-36 months. No complications were associated with use of Mitomycin C. In conclusion, intra-operative use of Mitomycin C in both endoscopic DCR and external DCR is safe and effective in increasing the success rate.

  2. Prospective randomized clinical studies involving reirradiation. Lessons learned

    International Nuclear Information System (INIS)

    Nieder, Carsten; Langendijk, Johannes A.; Guckenberger, Matthias; Grosu, Anca L.

    2016-01-01

    Reirradiation is a potentially useful option for many patients with recurrent cancer. The purpose of this study was to review all recently published randomized trials in order to identify methodological strengths and weaknesses, comment on the results, clinical implications and open questions, and give advice for the planning of future trials. Systematic review of trials published between 2000 and 2015 (databases searched were PubMed, Scopus and Web of Science). We reviewed 9 trials, most of which addressed reirradiation of head and neck tumours. The median number of patients was 69. Trial design, primary endpoint and statistical hypotheses varied widely. The results contribute mainly to decision making for reirradiation of nasopharynx cancer and bone metastases. The trials with relatively long median follow-up confirm that serious toxicity remains a concern after high cumulative total doses. Multi-institutional collaboration is encouraged to complete sufficiently large trials. Despite a paucity of large randomized studies, reirradiation has been adopted in different clinical scenarios by many institutions. Typically, the patients have been assessed by multidisciplinary tumour boards and advanced technologies are used to create highly conformal dose distributions. (orig.) [de

  3. Selective decontamination in pediatric liver transplants. A randomized prospective study.

    Science.gov (United States)

    Smith, S D; Jackson, R J; Hannakan, C J; Wadowsky, R M; Tzakis, A G; Rowe, M I

    1993-06-01

    Although it has been suggested that selective decontamination of the digestive tract (SDD) decreases postoperative aerobic Gram-negative and fungal infections in orthotopic liver transplantation (OLT), no controlled trials exist in pediatric patients. This prospective, randomized controlled study of 36 pediatric OLT patients examines the effect of short-term SDD on postoperative infection and digestive tract flora. Patients were randomized into two groups. The control group received perioperative parenteral antibiotics only. The SDD group received in addition polymyxin E, tobramycin, and amphotericin B enterally and by oropharyngeal swab postoperatively until oral intake was tolerated (6 +/- 4 days). Indications for operation, preoperative status, age, and intensive care unit and hospital length of stay were no different in SDD (n = 18) and control (n = 18) groups. A total of 14 Gram-negative infections (intraabdominal abscess 7, septicemia 5, pneumonia 1, urinary tract 1) developed in the 36 patients studied. Mortality was not significantly different in the two groups. However, there were significantly fewer patients with Gram-negative infections in the SDD group: 3/18 patients (11%) vs. 11/18 patients (50%) in the control group, P < 0.001. There was also significant reduction in aerobic Gram-negative flora in the stool and pharynx in patients receiving SDD. Gram-positive and anaerobic organisms were unaffected. We conclude that short-term postoperative SDD significantly reduces Gram-negative infections in pediatric OLT patients.

  4. Balneotherapy in fibromyalgia: a single blind randomized controlled clinical study.

    Science.gov (United States)

    Ozkurt, Seçil; Dönmez, Arif; Zeki Karagülle, M; Uzunoğlu, Emel; Turan, Mustafa; Erdoğan, Nergis

    2012-07-01

    We aimed to evaluate the effectiveness of balneotherapy in fibromyalgia management. Fifty women with fibromyalgia under pharmacological treatment were randomly assigned to either the balneotherapy (25) or the control (25) group. Four patients from the balneotherapy group and one patient from the control group left the study after randomization. The patients in the balneotherapy group (21) had 2 thermomineral water baths daily for 2 weeks in Tuzla Spa Center. The patients in the control group (24) continued to have their medical treatment and routine daily life. An investigator who was blinded to the study arms assessed the patients. All patients were assessed four times; at the beginning of the study, at the end of the 2nd week, the 1st month, and the 3rd month after balneotherapy. Outcome measures of the study were pain intensity, Fibromyalgia Impact Questionnaire (FIQ), Beck Depression Inventory (BDI), patient's global assessment, investigator's global assessment, SF-36 scores, and tender point count. Balneotherapy was found to be superior at the end of the cure period in terms of pain intensity, FIQ, Beck Depression Inventory, patient's global assessment, investigator's global assessment scores, and tender point count as compared to the control group. The superiority of balneotherapy lasted up to the end of the 3rd month, except for the Beck Depression Inventory score and the investigator's global assessment score. Significant improvements were observed in PF, GH, and MH subscales of SF-36 during the study period in the balneotherapy group; however, no such improvement was observed in the control group. Balneotherapy was superior only in VT subscale at the end of therapy and at the end of the third month after the therapy as compared to the controls. It was concluded that balneotherapy provides beneficial effects in patients with fibromyalgia.

  5. A comparison of random forest regression and multiple linear regression for prediction in neuroscience.

    Science.gov (United States)

    Smith, Paul F; Ganesh, Siva; Liu, Ping

    2013-10-30

    Regression is a common statistical tool for prediction in neuroscience. However, linear regression is by far the most common form of regression used, with regression trees receiving comparatively little attention. In this study, the results of conventional multiple linear regression (MLR) were compared with those of random forest regression (RFR), in the prediction of the concentrations of 9 neurochemicals in the vestibular nucleus complex and cerebellum that are part of the l-arginine biochemical pathway (agmatine, putrescine, spermidine, spermine, l-arginine, l-ornithine, l-citrulline, glutamate and γ-aminobutyric acid (GABA)). The R(2) values for the MLRs were higher than the proportion of variance explained values for the RFRs: 6/9 of them were ≥ 0.70 compared to 4/9 for RFRs. Even the variables that had the lowest R(2) values for the MLRs, e.g. ornithine (0.50) and glutamate (0.61), had much lower proportion of variance explained values for the RFRs (0.27 and 0.49, respectively). The RSE values for the MLRs were lower than those for the RFRs in all but two cases. In general, MLRs seemed to be superior to the RFRs in terms of predictive value and error. In the case of this data set, MLR appeared to be superior to RFR in terms of its explanatory value and error. This result suggests that MLR may have advantages over RFR for prediction in neuroscience with this kind of data set, but that RFR can still have good predictive value in some cases. Copyright © 2013 Elsevier B.V. All rights reserved.

  6. Randomized Crossover Comparison of Personalized MPC and PID Control Algorithms for the Artificial Pancreas.

    Science.gov (United States)

    Pinsker, Jordan E; Lee, Joon Bok; Dassau, Eyal; Seborg, Dale E; Bradley, Paige K; Gondhalekar, Ravi; Bevier, Wendy C; Huyett, Lauren; Zisser, Howard C; Doyle, Francis J

    2016-07-01

    To evaluate two widely used control algorithms for an artificial pancreas (AP) under nonideal but comparable clinical conditions. After a pilot safety and feasibility study (n = 10), closed-loop control (CLC) was evaluated in a randomized, crossover trial of 20 additional adults with type 1 diabetes. Personalized model predictive control (MPC) and proportional integral derivative (PID) algorithms were compared in supervised 27.5-h CLC sessions. Challenges included overnight control after a 65-g dinner, response to a 50-g breakfast, and response to an unannounced 65-g lunch. Boluses of announced dinner and breakfast meals were given at mealtime. The primary outcome was time in glucose range 70-180 mg/dL. Mean time in range 70-180 mg/dL was greater for MPC than for PID (74.4 vs. 63.7%, P = 0.020). Mean glucose was also lower for MPC than PID during the entire trial duration (138 vs. 160 mg/dL, P = 0.012) and 5 h after the unannounced 65-g meal (181 vs. 220 mg/dL, P = 0.019). There was no significant difference in time with glucose PID control for the AP indicates that MPC performed particularly well, achieving nearly 75% time in the target range, including the unannounced meal. Although both forms of CLC provided safe and effective glucose management, MPC performed as well or better than PID in all metrics. © 2016 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

  7. Beauveria keratitis and biopesticides: case histories and a random amplification of polymorphic DNA comparison.

    Science.gov (United States)

    Pariseau, Brett; Nehls, Sarah; Ogawa, Gregory S H; Sutton, Deanna A; Wickes, Brian L; Romanelli, Anna M

    2010-02-01

    The purposes of this study were to describe 2 contact lens-associated Beauveria keratitis cases and to compare the isolates of 3 contact lens-associated Beauveria keratitis cases with Beauveria-based biopesticides using random amplification of polymorphic DNA (RAPD). A 55-year-old diabetic woman from New Mexico and a 31-year-old healthy woman from southern Wisconsin developed soft contact lens-related corneal ulcers unresponsive to topical moxifloxacin and prednisolone acetate drops. Their corneal cultures grew B. bassiana. These isolates, an isolate from a third soft contact lens-related Beauveria keratitis case, and Beauveria-based biopesticides sold in the United States were analyzed using morphological features, DNA sequencing, and RAPD. A PubMed, Cochrane Library, OVID, UpToDate, and Google search using the term "Beauveria" found only 9 reported Beauveria keratitis infections. Patient 1 responded to topical natamycin, ketoconazole, and 200 mg oral ketoconazole twice daily before developing a secondary bacterial infection requiring penetrating keratoplasty. After subsequent cataract surgery, the best-corrected visual acuity was 20/20. Patient 2 was treated with topical natamycin, topical amphotericin, and 200 mg oral voriconazole twice daily for 1 month with residual scarring and a best-corrected visual acuity of 20/25. RAPD showed that all isolates were unrelated. Although earlier reported Beauveria keratitis cases occurred after corneal injury in patients who did not wear contact lenses, 3 recent patients wore soft contact lenses and denied trauma, mirroring a changing trend in microbial keratitis. RAPD analysis showed that the Beauveria isolates were unrelated to one another and to Beauveria-based biopesticides. In Patient 2, oral voriconazole worked well.

  8. Buprenorphine Implants for Treatment of Opioid Dependence: Randomized Comparison to Placebo and Sublingual Buprenorphine/Naloxone

    Science.gov (United States)

    Rosenthal, Richard N.; Ling, Walter; Casadonte, Paul; Vocci, Frank; Bailey, Genie L.; Kampman, Kyle; Patkar, Ashwin; Chavoustie, Steven; Blasey, Christine; Sigmon, Stacey; Beebe, Katherine L.

    2015-01-01

    Aims To evaluate safety and efficacy of buprenorphine implants (BI) versus placebo implants (PI) for the treatment of opioid dependence. A secondary aim compared BI to open-label sublingual buprenorphine/naloxone tablets (BNX). Design Randomized, double-blind, placebo-controlled trial. Subjects received either 4 buprenorphine implants (80 mg/implant) (n=114), 4 placebo implants (n=54), or open-label BNX (12–16 mg/d) (n=119). Setting 20 addiction treatment centers. Participants Adult outpatients (ages 18 to 65) with DSM-IV-TR opioid dependence. Measurements The primary efficacy endpoint was the percent of urine samples negative for opioids collected from weeks 1 to 24, examined as a cumulative distribution function (CDF). Findings The BI CDF was significantly different from placebo (P<.0001). Mean (95% CI) proportions of urines negative for opioids were: BI: 31.2% (25.3, 37.1) and PI: 13.4% (8.3, 18.6). BI subjects had a higher study completion rate relative to placebo (64% vs. 26%, P<.0001), lower clinician-rated (P<.0001) and patient-rated (P<.0001) withdrawal, lower patient-ratings of craving (P<.0001), and better subjects’ (P=.031) and clinicians’ (P=.022) global ratings of improvement. BI also resulted in significantly lower cocaine use (P=.0016). Minor implant-site reactions were comparable in the buprenorphine (27.2% [31/114]) and placebo groups (25.9% [14/54]). BI were non-inferior to BNX on percent urines negative for opioids [mean (95% CI): 33.5 (27.3, 39.6); CI for the difference of proportions, (−10.7, 6.2)]. Conclusions Compared with placebo, buprenorphine implants result in significantly less frequent opioid use, and are non-inferior to sublingual buprenorphine/naloxone tablets. PMID:23919595

  9. Tolerance and diagnostic accuracy of an abbreviated adenosine infusion for myocardial scintigraphy: a randomized, prospective study.

    Science.gov (United States)

    Treuth, M G; Reyes, G A; He, Z X; Cwajg, E; Mahmarian, J J; Verani, M S

    2001-01-01

    The objectives of this study were 2-fold: (1) to determine the tolerance of adenosine perfusion tomography with the use of an abbreviated (3-minute) infusion in comparison to the standard (6-minute) infusion, and (2) to assess the relative diagnostic accuracy of a 3-minute adenosine infusion in patients referred for arteriography. An abbreviated adenosine infusion may decrease the frequency and duration of side effects and be a more cost-effective alternative. We prospectively randomized 599 patients undergoing adenosine myocardial perfusion tomography to either a 3-minute or 6-minute adenosine infusion at 140 microg/kg per minute. Among the 599 enrolled patients, 142 subsequently underwent coronary angiography. Patients randomized to the 3-minute adenosine infusion tolerated the procedure better than those randomized to the standard infusion (P <.01). Flushing, headache, neck pain, and atrioventricular block were all significantly less frequent (P <.01) with the abbreviated infusion. Moreover, patients receiving the abbreviated infusion had less hypotension and tachycardia (P <.05). The sensitivity of the test for detection of coronary artery disease was 88% for both the 3- and 6-minute infusions. In patients with abnormal scan results, perfusion defect size was slightly larger in those receiving a 6-minute infusion versus those receiving a 3-minute infusion (P =.05). An abbreviated 3-minute adenosine infusion, in combination with perfusion tomography, has similar sensitivity for detection of coronary artery disease and is better tolerated than the standard 6-minute infusion.

  10. Cognitive training in Alzheimer's disease: a controlled randomized study.

    Science.gov (United States)

    Giovagnoli, A R; Manfredi, V; Parente, A; Schifano, L; Oliveri, S; Avanzini, G

    2017-08-01

    This controlled randomized single-blind study evaluated the effects of cognitive training (CT), compared to active music therapy (AMT) and neuroeducation (NE), on initiative in patients with mild to moderate Alzheimer's disease (AD). Secondarily, we explored the effects of CT on episodic memory, mood, and social relationships. Thirty-nine AD patients were randomly assigned to CT, AMT, or NE. Each treatment lasted 3 months. Before, at the end, and 3 months after treatment, neuropsychological tests and self-rated scales assessed initiative, episodic memory, depression, anxiety, and social relationships. At the end of the CT, initiative significantly improved, whereas, at the end of AMT and NE, it was unchanged. Episodic memory showed no changes at the end of CT or AMT and a worsening after NE. The rates of the patients with clinically significant improvement of initiative were greater after CT (about 62%) than after AMT (about 8%) or NE (none). At the 3-month follow-up, initiative and episodic memory declined in all patients. Mood and social relationships improved in the three groups, with greater changes after AMT or NE. In patients with mild to moderate AD, CT can improve initiative and stabilize memory, while the non-cognitive treatments can ameliorate the psychosocial aspects. The combining of CT and non-cognitive treatments may have useful clinical implications.

  11. A prospective, randomized multicenter study comparing APD and CAPD treatment

    DEFF Research Database (Denmark)

    Bro, S; Bjorner, J B; Tofte-Jensen, P

    2000-01-01

    , dialysis-related complications, dialysis-related expenses. RESULTS: The quality-of-life studies showed that significantly more time for work, family, and social activities was available to patients on APD compared to those on CAPD (p ...) treatment with respect to quality of life and clinical outcomes in relation to therapy costs. DESIGN: A prospective, randomized multicenter study. SETTING: Three Danish CAPD units. PATIENTS: Thirty-four adequately dialyzed patients with high or high-average peritoneal transport characteristics were included...... were assessed at baseline and after 6 months by the self-administered short-form SF-36 generic health survey questionnaire supplemented with disease- and treatment-specific questions. Therapy costs were compared by evaluating dialysis-related expenses. MAIN OUTCOME MEASURES: Quality-of-life parameters...

  12. Empirical evidence of study design biases in randomized trials

    DEFF Research Database (Denmark)

    Page, Matthew J.; Higgins, Julian P. T.; Clayton, Gemma

    2016-01-01

    search September 2012), and searched Ovid MEDLINE and Ovid EMBASE for studies indexed from Jan 2012-May 2015. Data were extracted by one author and verified by another. We combined estimates of average bias (e.g. ratio of odds ratios (ROR) or difference in standardised mean differences (dSMD)) in meta......-analyses using the random-effects model. Analyses were stratified by type of outcome ("mortality" versus "other objective" versus "subjective"). Direction of effect was standardised so that ROR SMD ... studies). For these characteristics, the average bias appeared to be larger in trials of subjective outcomes compared with other objective outcomes. Also, intervention effects for subjective outcomes appear to be exaggerated in trials with lack of/unclear blinding of participants (versus blinding) (dSMD...

  13. Comparison of Registered and Reported Outcomes in Randomized Clinical Trials Published in Anesthesiology Journals.

    Science.gov (United States)

    Jones, Philip M; Chow, Jeffrey T Y; Arango, Miguel F; Fridfinnson, Jason A; Gai, Nan; Lam, Kevin; Turkstra, Timothy P

    2017-10-01

    Randomized clinical trials (RCTs) provide high-quality evidence for clinical decision-making. Trial registration is one of the many tools used to improve the reporting of RCTs by reducing publication bias and selective outcome reporting bias. The purpose of our study is to examine whether RCTs published in the top 6 general anesthesiology journals were adequately registered and whether the reported primary and secondary outcomes corresponded to the originally registered outcomes. Following a prespecified protocol, an electronic database was used to systematically screen and extract data from RCTs published in the top 6 general anesthesiology journals by impact factor (Anaesthesia, Anesthesia & Analgesia, Anesthesiology, British Journal of Anaesthesia, Canadian Journal of Anesthesia, and European Journal of Anaesthesiology) during the years 2007, 2010, 2013, and 2015. A manual search of each journal's Table of Contents was performed (in duplicate) to identify eligible RCTs. An adequately registered trial was defined as being registered in a publicly available trials registry before the first patient being enrolled with an unambiguously defined primary outcome. For adequately registered trials, the outcomes registered in the trial registry were compared with the outcomes reported in the article, with outcome discrepancies documented and analyzed by the type of discrepancy. During the 4 years studied, there were 860 RCTs identified, with 102 RCTs determined to be adequately registered (12%). The proportion of adequately registered trials increased over time, with 38% of RCTs being adequately registered in 2015. The most common reason in 2015 for inadequate registration was registering the RCT after the first patient had already been enrolled. Among adequately registered trials, 92% had at least 1 primary or secondary outcome discrepancy. In 2015, 42% of RCTs had at least 1 primary outcome discrepancy, while 90% of RCTs had at least 1 secondary outcome discrepancy

  14. Comparison of low- and high-carbohydrate diets for type 2 diabetes management: a randomized trial.

    Science.gov (United States)

    Tay, Jeannie; Luscombe-Marsh, Natalie D; Thompson, Campbell H; Noakes, Manny; Buckley, Jonathan D; Wittert, Gary A; Yancy, William S; Brinkworth, Grant D

    2015-10-01

    Few well-controlled studies have comprehensively examined the effects of very-low-carbohydrate diets on type 2 diabetes (T2D). We compared the effects of a very-low-carbohydrate, high-unsaturated fat, low-saturated fat (LC) diet with a high-carbohydrate, low-fat (HC) diet on glycemic control and cardiovascular disease risk factors in T2D after 52 wk. In this randomized controlled trial that was conducted in an outpatient research clinic, 115 obese adults with T2D [mean ± SD age: 58 ± 7 y; body mass index (in kg/m(2)): 34.6 ± 4.3; glycated hemoglobin (HbA1c): 7.3 ± 1.1%; duration of diabetes: 8 ± 6 y] were randomly assigned to consume either a hypocaloric LC diet [14% of energy as carbohydrate (carbohydrate fasting blood glucose, glycemic variability assessed with use of 48-h continuous glucose monitoring, diabetes medication, weight, blood pressure, and lipids assessed at baseline, 24, and 52 wk. Both groups achieved similar completion rates (LC diet: 71%; HC diet: 65%) and mean (95% CI) reductions in weight [LC diet: -9.8 kg (-11.7, -7.9 kg); HC diet: -10.1 kg (-12.0, -8.2 kg)], blood pressure [LC diet: -7.1 (-10.6, -3.7)/-6.2 (-8.2, -4.1) mm Hg; HC diet: -5.8 (-9.4, -2.2)/-6.4 (-8.4, -4.3) mm Hg], HbA1c [LC diet: -1.0% (-1.2%, -0.7%); HC diet: -1.0% (-1.3%, -0.8%)], fasting glucose [LC diet: -0.7 mmol/L (-1.3, -0.1 mmol/L); HC diet: -1.5 mmol/L (-2.1, -0.8 mmol/L)], and LDL cholesterol [LC diet: -0.1 mmol/L (-0.3, 0.1 mmol/L); HC diet: -0.2 mmol/L (-0.4, 0.03 mmol/L)] (P-diet effect ≥ 0.10). Compared with the HC-diet group, the LC-diet group achieved greater mean (95% CI) reductions in the diabetes medication score [LC diet: -0.5 arbitrary units (-0.7, -0.4 arbitrary units); HC diet: -0.2 arbitrary units (-0.4, -0.06 arbitrary units); P = 0.02], glycemic variability assessed by measuring the continuous overall net glycemic action-1 [LC diet: -0.5 mmol/L (-0.6, -0.3 mmol/L); HC diet: -0.05 mmol/L (-0.2, -0.1 mmol/L); P = 0.003], and triglycerides [LC diet

  15. Comparison of nuisance parameters in pediatric versus adult randomized trials: a meta-epidemiologic empirical evaluation

    NARCIS (Netherlands)

    Vandermeer, Ben; van der Tweel, Ingeborg; Jansen-van der Weide, Marijke C.; Weinreich, Stephanie S.; Contopoulos-Ioannidis, Despina G.; Bassler, Dirk; Fernandes, Ricardo M.; Askie, Lisa; Saloojee, Haroon; Baiardi, Paola; Ellenberg, Susan S.; van der Lee, Johanna H.

    2018-01-01

    Background: We wished to compare the nuisance parameters of pediatric vs. adult randomized-trials (RCTs) and determine if the latter can be used in sample size computations of the former. Methods: In this meta-epidemiologic empirical evaluation we examined meta-analyses from the Cochrane Database of

  16. Comparison of manual therapy and exercise therapy in osteoarthritis of the hip: a randomized clinical trial.

    NARCIS (Netherlands)

    Hoeksma, H.L.; Dekker, J.; Ronday, H.K.; Heering, A.; Lubbe, N. van der; Vel, C.; Breedveld, F.C.; Ende, C.H.M. van den

    2004-01-01

    OBJECTIVE: To determine the effectiveness of a manual therapy program compared with an exercise therapy program in patients with osteoarthritis (OA) of the hip. METHODS: A single-blind, randomized clinical trial of 109 hip OA patients was carried out in the outpatient clinic for physical therapy of

  17. Randomized Trial Comparison of Emotion Regulation and Relational Psychotherapies for PTSD with Girls Involved in Delinquency

    Science.gov (United States)

    Ford, Julian D.; Steinberg, Karen L.; Hawke, Josephine; Levine, Joan; Zhang, Wanli

    2012-01-01

    Posttraumatic stress disorder (PTSD) is prevalent in youth involved in delinquency, but it is often not effectively treated. A randomized clinical trial was conducted comparing the outcomes of an emotion regulation therapy (Trauma Affect Regulation: Guide for Education and Therapy, or TARGET) with a relational supportive therapy (Enhanced…

  18. Randomized Comparison of Two Communication Interventions for Preschoolers with Autism Spectrum Disorders

    Science.gov (United States)

    Yoder, Paul; Stone, Wendy L.

    2006-01-01

    This randomized group experiment compared the efficacy of 2 communication interventions (Responsive Education and Prelinguistic Milieu Teaching [RPMT] and the Picture Exchange Communication System [PECS]) in 36 preschoolers with autism spectrum disorders. Each treatment was delivered 3 times per week, in 20-min sessions, for 6 months. The results…

  19. A photon dominated region code comparison study

    NARCIS (Netherlands)

    Roellig, M.; Abel, N. P.; Bell, T.; Bensch, F.; Black, J.; Ferland, G. J.; Jonkheid, B.; Kamp, I.; Kaufman, M. J.; Le Bourlot, J.; Le Petit, F.; Meijerink, R.; Morata, O.; Ossenkopf, Volker; Roueff, E.; Shaw, G.; Spaans, M.; Sternberg, A.; Stutzki, J.; Thi, W.-F.; van Dishoeck, E. F.; van Hoof, P. A. M.; Viti, S.; Wolfire, M. G.

    Aims. We present a comparison between independent computer codes, modeling the physics and chemistry of interstellar photon dominated regions (PDRs). Our goal was to understand the mutual differences in the PDR codes and their effects on the physical and chemical structure of the model clouds, and

  20. Effective permittivity of random composite media: A comparative study

    International Nuclear Information System (INIS)

    Prasad, Ashutosh; Prasad, K.

    2007-01-01

    In the present study, experimental data for effective permittivity of amorphous, polycrystalline thick films, and ceramic form of samples, taken from the literature, have been chosen for their comparison with those yielded by different mixture equations. In order to test the acceptability of dielectric mixture equations for high volume fractions of the inclusion material in the mixture, eleven such equations have been chosen. It is found that equations given by Cuming, Maxwell-Wagner, Webmann, Skipetrov and modified Cule-Torquato show their coherence and minimal deviation from the experimental results of permittivity for all the chosen test materials almost over the entire measurement range of volume fractions. It is further found that Maxwell-Wagner, Webmann, and Skipetrov equations yielded equivalent results and consequently they have been combined together and reckoned as a single equation named MWWS. The study revealed that the Cuming equation had the highest degree of acceptability (errors <±1-5%) in all the cases

  1. A randomized comparison of electrocautery incision with Savary bougienage for relief of anastomotic gastroesophageal strictures

    NARCIS (Netherlands)

    Hordijk, Marjan L.; van Hooft, Jeanin E.; Hansen, Bettina E.; Fockens, Paul; Kuipers, Ernst J.

    2009-01-01

    Background: Benign gastroesophageal anastomotic strictures are common and often refractory to treatment. Various endoscopic dilation techniques have been reported, but none of these methods has been proven to be superior. Objective: Comparison of the efficacy and safety of dilation of previously

  2. Comparison of the efficacy and safety profiles of two fixed-dose combinations of antihypertensive agents, amlodipine/benazepril versus valsartan/hydrochlorothiazide, in patients with type 2 diabetes mellitus and hypertension: a 16-week, multicenter, randomized, double-blind, noninferiority study.

    Science.gov (United States)

    Lee, I-Te; Hung, Yi-Jen; Chen, Jung-Fu; Wang, Chih-Yuan; Lee, Wen-Jane; Sheu, Wayne Huey-Herng

    2012-08-01

    Hypertension is a prevalent condition that is closely associated with chronic complications in patients with diabetes. Fixed-dose combination therapy is currently recommended for the treatment of hypertension due to the advantage of reducing the pill burden. However, the effects of combination therapy may be diverse because of the different components. We examined blood pressure reduction and metabolic alterations after amlodipine/benazepril and valsartan/hydrochlorothiazide treatment in patients with type 2 diabetes mellitus and hypertension and microalbuminuria. This randomized, double-blind, parallel comparison, noninferiority clinical trial included patients with type 2 diabetes mellitus and hypertension and microalbuminuria detected within the past year. After a 2-week, placebo run-in period, patients were assigned to treatment with amlodipine/benazepril or valsartan/hydrochlorothiazide for 16 weeks. The primary end point was mean change in diastolic blood pressure. The prespecified boundary for noninferiority was 3.5 mm Hg of the mean change in diastolic blood pressure between treatments (amlodipine/benazepril minus valsartan/hydrochlorothiazide). If the upper limit of the 95% CI fell within 3.5 mm Hg, amlodipine/benazepril would be considered noninferior to valsartan/hydrochlorothiazide. Of the 226 patients assessed for eligibility, 169 satisfied the inclusion/exclusion criteria and were assigned to a treatment group; 83 patients (54.2% male, mean age of 60.5 [10.0] years) in the amlodipine/benazepril group and 84 patients (64.3% male, mean age of 59.0 [10.6] years) in the valsartan/hydrochlorothiazide group received at least 1 dose of study medication and were included in the intention-to-treat population. In the per-protocol population, amlodipine/benazepril (n = 74) was noninferior to valsartan/hydrochlorothiazide (n = 78) with regard to the mean change in diastolic blood pressure (difference, -0.9 mm Hg; 95% CI, -3.5 to 1.6). The mean change in systolic

  3. Building Kindergartners' Number Sense: A Randomized Controlled Study.

    Science.gov (United States)

    Jordan, Nancy C; Glutting, Joseph; Dyson, Nancy; Hassinger-Das, Brenna; Irwin, Casey

    2012-08-01

    Math achievement in elementary school is mediated by performance and growth in number sense during kindergarten. The aim of the present study was to test the effectiveness of a targeted small group number sense intervention for high-risk kindergartners from low-income communities. Children were randomly assigned to one of three groups ( n = 44 in each group): a number sense intervention group, a language intervention group, or a business as usual control group. Accounting for initial skill level in mathematical knowledge, children who received the number sense intervention performed better than controls at immediate post test, with meaningful effects on measures of number competencies and general math achievement. Many of the effects held eight weeks after the intervention was completed, suggesting that children internalized what they had learned. There were no differences between the language and control groups on any math-related measures.

  4. Building Kindergartners’ Number Sense: A Randomized Controlled Study

    Science.gov (United States)

    Jordan, Nancy C.; Glutting, Joseph; Dyson, Nancy; Hassinger-Das, Brenna; Irwin, Casey

    2015-01-01

    Math achievement in elementary school is mediated by performance and growth in number sense during kindergarten. The aim of the present study was to test the effectiveness of a targeted small group number sense intervention for high-risk kindergartners from low-income communities. Children were randomly assigned to one of three groups (n = 44 in each group): a number sense intervention group, a language intervention group, or a business as usual control group. Accounting for initial skill level in mathematical knowledge, children who received the number sense intervention performed better than controls at immediate post test, with meaningful effects on measures of number competencies and general math achievement. Many of the effects held eight weeks after the intervention was completed, suggesting that children internalized what they had learned. There were no differences between the language and control groups on any math-related measures. PMID:25866417

  5. A comparison of alcohol and drug use by random motor vehicle drivers in Brazil and Norway.

    Science.gov (United States)

    Gjerde, Hallvard; Sousa, Tanara R; De Boni, Raquel; Christophersen, Asbjørg S; Limberger, Renata P; Zancanaro, Ivomar; Oiestad, Elisabeth L; Normann, Per T; Mørland, Jørg; Pechansky, Flavio

    2014-05-01

    A large proportion of road traffic crashes are related to driving under the influence (DUI) of alcohol or drugs. The aim of this study was to compare the use of alcohol, illegal drugs and psychoactive medicinal drugs among random drivers in Brazil and Norway, two countries with the same legal limit for drunk driving, but with marked differences in legislation history, enforcement and penalties for DUI, and to discuss any differences found. Roadside surveys were conducted on Fridays and Saturdays between noon and midnight. Samples of oral fluid were collected for analysis of drugs, whereas alcohol was determined by breath testing or by analysis of oral fluid. High participation rates of 94-97% were obtained in both countries. The weighted prevalence of driving with alcohol concentrations in breath or oral fluid equivalent to blood alcohol concentrations (BAC) above 0.2g/L was 2.7% (95% CI 2.2-3.3) in Brazil and 0.2% (95% CI 0.0-0.5) in Norway. Stimulants (amphetamines or cocaine) were found in samples from 1.0% (95% CI 0.7-1.4) of drivers in Brazil and 0.3% (95% CI 0.1-0.7) in Norway. The prevalence of amphetamines was highest among Brazilian truck drivers (3.6%; 95% CI 2.0-6.4). Tetrahydrocannabinol was found in samples from 0.5% (95% CI 0.3-0.8) of drivers in Brazil and 1.0% (95% CI 0.6-1.5) in Norway, whereas benzodiazepines or zopiclone were found in 1.0% (95% CI 0.7-1.4) and 1.7% (95% CI 1.2-2.4) of the samples from Brazil and Norway, respectively. The difference in the prevalence of alcohol may be related to the fact that Norway has implemented steps to reduce drunk driving since 1936, whereas Brazil has attempted to do the same for only a few years. Differences for drugs may be related to different patterns in the use of stimulants, cannabis and medicines. Copyright © 2014 Elsevier B.V. All rights reserved.

  6. Partner randomized controlled trial: study protocol and coaching intervention

    Directory of Open Access Journals (Sweden)

    Garbutt Jane M

    2012-04-01

    Full Text Available Abstract Background Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. Methods and design This paper describes the protocol for a randomized controlled trial (RCT to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1 effective use of controller medications, 2 effective use of rescue medications and 3 monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1 the child's asthma control score, 2 the parent's quality of life score, and 3 the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications

  7. Feasibility of exercising adults with asthma: a randomized pilot study

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    Boyd Amy

    2012-08-01

    Full Text Available Abstract Background Aerobic exercise appears to have clinical benefits for many asthmatics, yet a complete understanding of the mechanisms underlying these benefits has not been elucidated at this time. Purpose The objective of this study was to determine feasibility for a larger, future study that will define the effect of aerobic exercise on cellular, molecular, and functional measures in adults with mild-moderate asthma. Design Recruited subjects were randomized into usual care (sedentary or usual care with moderate intensity aerobic exercise treatment groups. Setting / Participants Nineteen adults with mild-moderate asthma but without a recent history of exercise were recruited at the UAB Lung Health Center, Birmingham, AL. Intervention The exercise group underwent a 12 week walking program exercising at 60 – 75% of maximum heart rate (HRmax. Subjects self-monitored HRmax levels using heart rate monitors; exercise diaries and recreation center sign-in logs were also used. Main outcome measures Functional measures, including lung function and asthma control scores, were evaluated for all subjects at pre- and post-study time-points; fitness measures were also assessed for subjects in the exercise group. Peripheral blood and nasal lavage fluid were collected from all subjects at pre- and post-study visits in order to evaluate cellular and molecular measures, including cell differentials and eosinophilic cationic protein (ECP. Results Sixteen subjects completed the prescribed protocol. Results show that subjects randomized to the exercise group adhered well (80% to the exercise prescription and exhibited a trend toward improved fitness levels upon study completion. Both groups exhibited improvements in ACQ scores. No changes were observed in lung function (FEV1, FEV1/FVC, cell differentials, or ECP between groups. Conclusions Results indicate that a moderate intensity aerobic exercise training program may improve asthma control and fitness

  8. A comparison of observation-level random effect and Beta-Binomial models for modelling overdispersion in Binomial data in ecology & evolution

    Directory of Open Access Journals (Sweden)

    Xavier A. Harrison

    2015-07-01

    Full Text Available Overdispersion is a common feature of models of biological data, but researchers often fail to model the excess variation driving the overdispersion, resulting in biased parameter estimates and standard errors. Quantifying and modeling overdispersion when it is present is therefore critical for robust biological inference. One means to account for overdispersion is to add an observation-level random effect (OLRE to a model, where each data point receives a unique level of a random effect that can absorb the extra-parametric variation in the data. Although some studies have investigated the utility of OLRE to model overdispersion in Poisson count data, studies doing so for Binomial proportion data are scarce. Here I use a simulation approach to investigate the ability of both OLRE models and Beta-Binomial models to recover unbiased parameter estimates in mixed effects models of Binomial data under various degrees of overdispersion. In addition, as ecologists often fit random intercept terms to models when the random effect sample size is low (<5 levels, I investigate the performance of both model types under a range of random effect sample sizes when overdispersion is present. Simulation results revealed that the efficacy of OLRE depends on the process that generated the overdispersion; OLRE failed to cope with overdispersion generated from a Beta-Binomial mixture model, leading to biased slope and intercept estimates, but performed well for overdispersion generated by adding random noise to the linear predictor. Comparison of parameter estimates from an OLRE model with those from its corresponding Beta-Binomial model readily identified when OLRE were performing poorly due to disagreement between effect sizes, and this strategy should be employed whenever OLRE are used for Binomial data to assess their reliability. Beta-Binomial models performed well across all contexts, but showed a tendency to underestimate effect sizes when modelling non

  9. Yoga in Correctional Settings: A Randomized Controlled Study

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    Nóra Kerekes

    2017-10-01

    Full Text Available BackgroundThe effect of yoga in the reduction of depressive symptoms, anxiety, stress, anger as well as in the increased ability of behavioral control has been shown. These effects of yoga are highly relevant for prison inmates who often have poor mental health and low impulse control. While it has been shown that yoga and meditation can be effective in improving subjective well-being, mental health, and executive functioning within prison populations, only a limited number of studies have proved this, using randomized controlled settings.MethodsA total of 152 participants from nine Swedish correctional facilities were randomly assigned to a 10-week yoga group (one class a week; N = 77 or a control group (N = 75. Before and after the intervention period, participants answered questionnaires measuring stress, aggression, affective states, sleep quality, and psychological well-being and completed a computerized test measuring attention and impulsivity.ResultsAfter the intervention period, significant improvements were found on 13 of the 16 variables within the yoga group (e.g., less perceived stress, better sleep quality, an increased psychological and emotional well-being, less aggressive, and antisocial behavior and on two within the control group. Compared to the control group, yoga class participants reported significantly improved emotional well-being and less antisocial behavior after 10 weeks of yoga. They also showed improved performance on the computerized test that measures attention and impulse control.ConclusionIt can be concluded that the yoga practiced in Swedish correctional facilities has positive effects on inmates’ well-being and on considerable risk factors associated with recidivism, such as impulsivity and antisocial behavior. Accordingly, the results show that yoga practice can play an important part in the rehabilitation of prison inmates.

  10. A Randomized, Double-Blind, Crossover Comparison of MK-0929 and Placebo in the Treatment of Adults with ADHD

    Science.gov (United States)

    Rivkin, Anna; Alexander, Robert C.; Knighton, Jennifer; Hutson, Pete H.; Wang, Xiaojing J.; Snavely, Duane B.; Rosah, Thomas; Watt, Alan P.; Reimherr, Fred W.; Adler, Lenard A.

    2012-01-01

    Objective: Preclinical models, receptor localization, and genetic linkage data support the role of D4 receptors in the etiology of ADHD. This proof-of-concept study was designed to evaluate MK-0929, a selective D4 receptor antagonist as treatment for adult ADHD. Method: A randomized, double-blind, placebo-controlled, crossover study was conducted…

  11. People's Intuitions about Randomness and Probability: An Empirical Study

    Science.gov (United States)

    Lecoutre, Marie-Paule; Rovira, Katia; Lecoutre, Bruno; Poitevineau, Jacques

    2006-01-01

    What people mean by randomness should be taken into account when teaching statistical inference. This experiment explored subjective beliefs about randomness and probability through two successive tasks. Subjects were asked to categorize 16 familiar items: 8 real items from everyday life experiences, and 8 stochastic items involving a repeatable…

  12. Comparison of the effect of acupressure and pilates-based exercises on sleep quality of postmenopausal women: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Maryam Ahmadinezhad

    2017-01-01

    Full Text Available Background: Postmenopausal women experience a variety of symptoms, among which sleep disorder is one of the most common problems. Acupressure and Pilates exercise programs are effective nonpharmaceutical treatments which can improve sleep quality. In the present study, we aimed to compare the effects of acupressure and Pilates-based exercises on the sleep quality of postmenopausal women referred to medical clinics. Materials and Methods: In this single-blinded randomized controlled clinical trial, we recruited 108 women aged 40–60 years who were randomly assigned into one control and two intervention groups using balanced block randomization method (three groups of 36 each. The patients in the Pilates exercise group participated in an exercise training program of three 1-hour sessions per week for 6 consecutive weeks. The participants of acupressure group received acupressure intervention three times a week for 6 weeks. The sleep quality of all participants was assessed and recorded using the Pittsburgh Sleep Quality Index (PSQI once before and once after the intervention. Results: The results showed no statistically significant difference among the three groups on the total scores of sleep quality after the intervention. The intragroup comparison revealed that the changes in the mean total scores were significant in both the intervention groups (P < 0.001 but not in the control group (P = 0.76. Conclusions: Pilates-based exercises and acupressure can effectively improve women's sleep quality. Both techniques can be applied as effective alternative and complementary methods for improving sleep quality during the postmenopausal period.

  13. Reliability Study of Energy Harvesting from Sea Waves by Piezoelectric Patches Consideraing Random JONSWAP Wave Theory

    Directory of Open Access Journals (Sweden)

    M. Ettefagh

    2018-03-01

    Full Text Available One of the new methods for powering low-power electronic devices employed in the sea, is using of mechanical energies of sea waves. In this method, piezoelectric material is employed to convert the mechanical energy of sea waves into electrical energy. The advantage of this method is based on not implementing the battery charging system. Although, many studies have been done about energy harvesting from sea waves, energy harvesting with considering random JONWSAP wave theory is not fully studied up to now. The random JONSWAP wave model is a more realistic approximation of sea waves in comparison of Airy wave model. Therefore, in this paper a vertical beam with the piezoelectric patches, which is fixed to the seabed, is considered as energy harvester system. The energy harvesting system is simulated by MATLAB software, and then the vibration response of the beam and consequently the generated power is obtained considering the JONWSAP wave theory. In addition, the reliability of the system and the effect of piezoelectric patches uncertainties on the generated power are studied by statistical method. Furthermore, the failure possibility of harvester based on violation criteria is investigated.  

  14. The Comparison Study of Six University Archives

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    Chun-Fen Liu

    2004-03-01

    Full Text Available The university archives is not only the extension of a building, but also includes the archival records, archivists and equipments. The university archives is the historical memory of a university, which could let people to predict the future by reviewing the past. The university archives has abundant collections, both teachers and students can review history of this university. This paper mainly compares six university archives of Taiwan, and the interviewing method is used in this research. After comparison of the six university archives, we have found the six university archives have different organizational structures, budgets, and functions. Finally the authors propose some suggestions.[Article content in Chinese

  15. Prospective randomized clinical studies involving reirradiation. Lessons learned

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    Nieder, Carsten [Nordland Hospital, Department of Oncology and Palliative Medicine, Bodoe (Norway); University of Tromsoe, Department of Clinical Medicine, Faculty of Health Sciences, Tromsoe (Norway); Langendijk, Johannes A. [University Medical Centre Groningen, Department of Radiation Oncology, Groningen (Netherlands); Guckenberger, Matthias [University Hospital Zuerich, Department of Radiation Oncology, Zuerich (Switzerland); Grosu, Anca L. [University Hospital Freiburg, Department of Radiation Oncology, Freiburg (Germany)

    2016-10-15

    Reirradiation is a potentially useful option for many patients with recurrent cancer. The purpose of this study was to review all recently published randomized trials in order to identify methodological strengths and weaknesses, comment on the results, clinical implications and open questions, and give advice for the planning of future trials. Systematic review of trials published between 2000 and 2015 (databases searched were PubMed, Scopus and Web of Science). We reviewed 9 trials, most of which addressed reirradiation of head and neck tumours. The median number of patients was 69. Trial design, primary endpoint and statistical hypotheses varied widely. The results contribute mainly to decision making for reirradiation of nasopharynx cancer and bone metastases. The trials with relatively long median follow-up confirm that serious toxicity remains a concern after high cumulative total doses. Multi-institutional collaboration is encouraged to complete sufficiently large trials. Despite a paucity of large randomized studies, reirradiation has been adopted in different clinical scenarios by many institutions. Typically, the patients have been assessed by multidisciplinary tumour boards and advanced technologies are used to create highly conformal dose distributions. (orig.) [German] Eine Rebestrahlung kann fuer viele Patienten mit rezidivierenden Malignomen eine nuetzliche Option bieten. Der Zweck dieser Studie bestand darin, alle in der juengeren Vergangenheit publizierten randomisierten Studien zu beurteilen, da deren methodische Staerken und Schwaechen, Ergebnisse und resultierende Implikationen bzw. offene Fragen die Planung kuenftiger Studien wesentlich beeinflussen koennen. Systematische Uebersicht aller zwischen 2000 und 2015 veroeffentlichten Studien (Literatursuche ueber PubMed, Scopus und Web of Science). Ausgewertet wurden 9 Studien, in die vor allem Patienten mit Kopf-Hals-Tumoren eingeschlossen waren. Im Median hatten 69 Patienten teilgenommen. Das

  16. Glove failure in elective thyroid surgery: A prospective randomized study

    Directory of Open Access Journals (Sweden)

    Dariusz Timler

    2015-06-01

    Full Text Available Objectives: To analyze perforation rate in sterile gloves used by surgeons in the operating theatre of the Department of Endocrinological and General Surgery of Medical University of Lodz. Material and Methods: Randomized and controlled trial. This study analyses the incidents of tears in sterile surgical gloves used by surgeons during operations on 3 types of thyroid diseases according to the 10th revision of International Statistical Classification of Diseases and Related Health Problems (ICD-10 codes. Nine hundred seventy-two pairs (sets of gloves were collected from 321 surgical procedures. All gloves were tested immediately following surgery using the water leak test (EN455-1 to detect leakage. Results: Glove perforation was detected in 89 of 972 glove sets (9.2%. Statistically relevant more often glove tears occurred in operator than the 1st assistant (p < 0.001. The sites of perforation were localized mostly on the middle finger of the non-dominant hand (22.5%, and the non-dominant ring finger (17.9%. Conclusions: This study has proved that the role performed by the surgeon during the procedure (operator, 1st assistant has significant influence on the risk of glove perforations. Nearly 90% of glove perforations are unnoticed during surgery.

  17. Left ventricular mass regression after porcine versus bovine aortic valve replacement: a randomized comparison.

    Science.gov (United States)

    Suri, Rakesh M; Zehr, Kenton J; Sundt, Thoralf M; Dearani, Joseph A; Daly, Richard C; Oh, Jae K; Schaff, Hartzell V

    2009-10-01

    It is unclear whether small differences in transprosthetic gradient between porcine and bovine biologic aortic valves translate into improved regression of left ventricular (LV) hypertrophy after aortic valve replacement. We investigated transprosthetic gradient, aortic valve orifice area, and LV mass in patients randomized to aortic valve replacement with either the Medtronic Mosaic (MM) porcine or an Edwards Perimount (EP) bovine pericardial bioprosthesis. One hundred fifty-two patients with aortic valve disease were randomly assigned to receive either the MM (n = 76) or an EP prosthesis. There were 89 men (59%), and the mean age was 76 years. Echocardiograms from preoperative, postoperative, predismissal, and 1-year time points were analyzed. Baseline characteristics and preoperative echocardiograms were similar between the two groups. The median implant size was 23 mm for both. There were no early deaths, and 10 patients (7%) died after dismissal. One hundred seven of 137 patients (78%) had a 1-year echocardiogram, and none required aortic valve reoperation. The mean aortic valve gradient at dismissal was 19.4 mm Hg (MM) versus13.5 mm Hg (EP; p regression of LV mass index (MM, -32.4 g/m(2) versus EP, -27.0 g/m(2); p = 0.40). Greater preoperative LV mass index was the sole independent predictor of greater LV mass regression after surgery (p regression of LV mass during the first year after aortic valve replacement.

  18. Evaluation of silodosin in comparison to tamsulosin in benign prostatic hyperplasia: a randomized controlled trial.

    Science.gov (United States)

    Pande, Satabdi; Hazra, Avijit; Kundu, Anup Kumar

    2014-01-01

    Benign prostatic hyperplasia (BPH) is the most common cause of lower urinary tract symptoms in elderly men. Selective alfa1-adrenergic antagonists are now first-line drugs in the medical management of BPH. We conducted a single-blind, parallel group, randomized, controlled trial to compare the effectiveness and safety of the new alfa1-blocker silodosin versus the established drug tamsulosin in symptomatic BPH. Ambulatory male BPH patients, aged above 50 years, were recruited on the basis of International Prostate Symptom Score (IPSS). Subjects were randomized in 1:1 ratio to receive either tamsulosin 0.4 mg controlled release or silodosin 8 mg once daily after dinner for 12 weeks. Primary outcome measure was reduction in IPSS. Proportion of subjects who achieved IPSS tamsulosin were analyzed. Final IPSS at 12-week was significantly less than baseline for both groups. However, groups remained comparable in terms of IPSS at all visits. There was a significant impact on sexual function (assessed by IPSS sexual function score) in silodosin arm compared with tamsulosin. Prostate size and uroflowmetry parameters did not change. Both treatments were well-tolerated. Retrograde ejaculation was encountered only with silodosin and postural hypotension only with tamsulosin. Silodosin is comparable to tamsulosin in the treatment of BPH in Indian men. However, retrograde ejaculation may be troublesome for sexually active patients.

  19. A prospective randomized study comparing unipolar versus bipolar hysteroscopic myomectomy in infertile women

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    Kallol K Roy

    2017-01-01

    Full Text Available Study Objective: To compare the operative and reproductive outcome of hysteroscopic myomectomy using unipolar resectoscope versus bipolar resectoscope in patients with infertility and menorrhagia. Design: Randomized, prospective, parallel, comparative, single-blinded study. Design Classification: Canadian Task Force classification I. Setting: Tertiary care institute. Patients: Sixty women with submucous myoma and infertility. Interventions: Hysteroscopic myomectomy performed with unipolar resectoscope or bipolar resectoscope. Measurements: Primary outcome measures were the pregnancy-related indicators. Secondary outcome measures were the operative parameters, harmful outcomes related to the procedure, and comparison of improvement levels in the menstrual pattern after surgery between the two groups. Main Results: A total of 60 patients were randomized into two groups of equal size. Baseline characteristics were not significantly different between the two groups. Reduction in sodium level from pre- to postsurgery was significantly (P = 0.001 higher in the unipolar group. Nine patients (30% in the unipolar group had hyponatremia in the postoperative period compared to none in the bipolar group (P = 0.002. However, there was no significant difference in the other operative parameters between the two groups. In both the groups, a significant improvement in the menstrual symptoms was observed after myomectomy. Pregnancy-related outcomes were similar in both the groups. Conclusion: The use of bipolar resectoscope for hysteroscopic myomectomy is associated with lesser risk of hyponatremia compared to unipolar resectoscope. Bipolar resectoscopic myomectomy is found to be an effective and safer alternative to unipolar resectoscopy with similar reproductive outcome.

  20. Randomized Comparison of the Therapeutic Effect of Acupuncture, Massage, and Tachibana-Style-Method on Stiff Shoulders by Measuring Muscle Firmness, VAS, Pulse, and Blood Pressure

    Directory of Open Access Journals (Sweden)

    Kazuhiro Tachibana

    2012-01-01

    Full Text Available To compare the therapeutic efficacy of acupuncture, massage, and Tachibana-Ryojutsu (one of Japanese traditional body balance therapy techniques (SEITAI, on stiff shoulders, the subjects’ muscle firmness, blood pressure, pulse, VAS, and body temperature were measured before and after the treatment. Forty-seven volunteer subjects gave written informed consent to participate in this study. The subjects were randomly divided into three groups to receive acupuncture, massage, or Tachibana-Ryojutsu. Each therapy lasted for 90 seconds. The acupuncture treatment was applied by a retaining-needle at GB-21, massage was conducted softly on the shoulders, and Tachibana-Ryojutsu treated only the muscles and joints from the legs to buttocks without touching the shoulders or backs. The study indicated that the muscle firmness and VAS of the Tachibana-Ryojutsu group decreased significantly in comparison with the acupuncture and massage groups after treatment.

  1. Comparison between conventional and piezoelectric surgical tools for maxillary sinus floor elevation : a randomized controlled clinical trial

    NARCIS (Netherlands)

    Rickert, Daniela; Vissink, Arjan; Huddleston Slater, James; Meijer, Henny J. A.; Raghoebar, Gerry M.

    Aim: The aim of this study was to assess the performance of conventional rotative instruments and a piezoelectric device for maxillary sinus floor elevation surgery, and to assess whether application of a resorbable membrane reduces resorption of an augmented site in a randomized clinical trial.

  2. A randomized comparison of ultrathin and standard colonoscope in cecal intubation rate and patient tolerance.

    Science.gov (United States)

    Luo, Derek J Y; Hui, Aric Josun; Yan, Kenneth Kar-Lung; Ng, Siew Chien; Wong, Vincent Wai-Sun; Chan, Francis Ka-Leung; Cheong, Jessica P K; Lam, Phyllis P Y; Tse, Yee Kit; Lau, James Y W

    2012-03-01

    Complete colonoscopy examination cannot be performed in as many as 10% of cases. The new 9.2-mm ultrathin colonoscope (UTC) with an extra bending section may improve procedure tolerance and allow improvement in colonoscopy completion rate compared with a 12.9-mm standard colonoscope (SC). To compare the performance of the 9.2-mm UTC with that of the 12.9-mm SC. Prospective, randomized, controlled trial. Academic endoscopic unit. Subjects 18 years and older undergoing their first colonoscopy. Subjects were randomized to either the UTC or SC group. First and rescue successful cecal intubation rates, subject satisfaction scores, and sedation requirements were compared. A total of 1121 patients (56% women, mean age 53.6 years) were randomized to the UTC group (n = 551) or the SC group (n = 570). There was no statistically significant difference in the first successful cecal intubation rate between the UTC and SC groups (98.9% vs 97.4%, P = .057). The mean (standard deviation) dose of midazolam and pethidine used was significantly lower in the UTC group (2.65 [0.65] mg vs 2.82 [0.85] mg, P < .001 and 27.6 [7.4] mg vs 29.7 [9.6] mg, P < .001, respectively). The mean (standard deviation) patient satisfaction score was similar between groups (6.99 [2.89] vs 7.04 [3.06], P = .762). Of the 21 patients (1.9%) with an incomplete initial colonoscopy (6 in the UTC group and 15 in the SC group), all 6 in the UTC group had their procedure completed with an SC. Eleven of 15 patients in the SC group had their procedures completed with a UTC in the same session. Low failure rate may mask any difference between the 2 colonoscopes as a rescue instrument. The 9.2-mm UTC has performance characteristics similar to those of an SC in Chinese subjects undergoing their first colonoscopy performed by experienced and trainee endoscopists. ( NCT01142167.). Copyright © 2012 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

  3. The Validity and Precision of the Comparative Interrupted Time-Series Design: Three Within-Study Comparisons

    Science.gov (United States)

    St. Clair, Travis; Hallberg, Kelly; Cook, Thomas D.

    2016-01-01

    We explore the conditions under which short, comparative interrupted time-series (CITS) designs represent valid alternatives to randomized experiments in educational evaluations. To do so, we conduct three within-study comparisons, each of which uses a unique data set to test the validity of the CITS design by comparing its causal estimates to…

  4. A comparison of observation-level random effect and Beta-Binomial models for modelling overdispersion in Binomial data in ecology & evolution.

    Science.gov (United States)

    Harrison, Xavier A

    2015-01-01

    Overdispersion is a common feature of models of biological data, but researchers often fail to model the excess variation driving the overdispersion, resulting in biased parameter estimates and standard errors. Quantifying and modeling overdispersion when it is present is therefore critical for robust biological inference. One means to account for overdispersion is to add an observation-level random effect (OLRE) to a model, where each data point receives a unique level of a random effect that can absorb the extra-parametric variation in the data. Although some studies have investigated the utility of OLRE to model overdispersion in Poisson count data, studies doing so for Binomial proportion data are scarce. Here I use a simulation approach to investigate the ability of both OLRE models and Beta-Binomial models to recover unbiased parameter estimates in mixed effects models of Binomial data under various degrees of overdispersion. In addition, as ecologists often fit random intercept terms to models when the random effect sample size is low (model types under a range of random effect sample sizes when overdispersion is present. Simulation results revealed that the efficacy of OLRE depends on the process that generated the overdispersion; OLRE failed to cope with overdispersion generated from a Beta-Binomial mixture model, leading to biased slope and intercept estimates, but performed well for overdispersion generated by adding random noise to the linear predictor. Comparison of parameter estimates from an OLRE model with those from its corresponding Beta-Binomial model readily identified when OLRE were performing poorly due to disagreement between effect sizes, and this strategy should be employed whenever OLRE are used for Binomial data to assess their reliability. Beta-Binomial models performed well across all contexts, but showed a tendency to underestimate effect sizes when modelling non-Beta-Binomial data. Finally, both OLRE and Beta-Binomial models performed

  5. Randomized comparison of two Internet-supported fertility-awareness-based methods of family planning.

    Science.gov (United States)

    Fehring, Richard J; Schneider, Mary; Raviele, Kathleen; Rodriguez, Dana; Pruszynski, Jessica

    2013-07-01

    The aim was to compare the efficacy and acceptability of two Internet-supported fertility-awareness-based methods of family planning. Six hundred and sixty-seven women and their male partners were randomized into either an electronic hormonal fertility monitor (EHFM) group or a cervical mucus monitoring (CMM) group. Both groups utilized a Web site with instructions, charts and support. Acceptability was assessed online at 1, 3 and 6 months. Pregnancy rates were determined by survival analysis. The EHFM participants (N=197) had a total pregnancy rate of 7 per 100 users over 12 months of use compared with 18.5 for the CMM group (N=164). The log rank survival test showed a significant difference (pincreased significantly over time (pusers had an increase in acceptability over time. Results are tempered by the high dropout rate. Copyright © 2013 Elsevier Inc. All rights reserved.

  6. Treatment of varicocele: a prospective randomized comparison of laparoscopy versus antegrade sclerotherapy.

    Science.gov (United States)

    Sautter, T; Sulser, T; Suter, St; Gretener, H; Hauri, D

    2002-04-01

    To compare the therapeutic success, the morbidity and the costs of antegrade sclerotherapy versus laparoscopic varicocelectomy. Seventy-six consecutive varicocele patients were randomly assigned to two treatment arms. Preoperative and 3 month postoperative sperm density, motility and morphology were analysed. The diagnosis of the varicocele was established clinically and with Doppler ultrasonography. Fifty-eight patients treated by either of the two methods were followed up. The recurrence rate increased progressively with the size of the varicocele in both groups. The postoperative incidence of complications particularly hydrocele formation was significantly higher in the laparoscopic group. The costs of the disposable material for laparoscopic varicocelectomy was twice as high as for sclerotherapy. Antegrade sclerotherapy is the less invasive treatment method of male varicocele with lower costs and better outcome and should therefore be the preferred treatment method for male varicocele.

  7. Effectiveness of PELOID therapy in carpal tunnel syndrome: A randomized controlled single blind study

    Science.gov (United States)

    Metin Ökmen, Burcu; Kasapoğlu Aksoy, Meliha; Güneş, Aygül; Eröksüz, Riza; Altan, Lale

    2017-08-01

    Carpal tunnel syndrome(CTS) is the most common neuromuscular cause of upper extremity disability. We aimed to investigate the effectiveness of peloid therapy in patients with CTS. This randomized, controlled, single-blind study enrolled 70 patients between the ages of 30 to 65 who had a diagnosis of either mild, mild-to-moderate, or moderate CTS. The patients were randomized into two groups using random number table. In the first group, (Group 1)( n = 35), patients were given splint (every night for 6 weeks) + peloid treatment(five consecutive days a week for 2 weeks) and in the second group, (Group 2)( n = 28), patients received splint treatment(every night for 6 weeks) alone. The patients were assessed by using visual analog scale(VAS) for pain, electroneuromyography(ENMG), the Boston Carpal Tunnel Syndrome Questionnaire(BCTSQ), hand grip strength(HGS), finger grip strength(FGS), and Short Form-12(SF-12). The data were obtained before treatment(W0), immediately after treatment(W2), and one month after treatment(W6). Both in Group 1 and 2, there was a statistically significant improvement in all the evaluation parameters at W2 and W6 when compared to W0( p < 0.05). Comparison of the groups with each other revealed significantly better results for VAS, BCTSQ, mSNCV, SF-12 in Group 1 than in Group 2 at W2( p < 0.05). There was also a statistically significant difference in favor of Group 1 for VAS, BCTSQ, FGS and MCS at W6 when compared to W0 ( p < 0.05). The results of our study demonstrated that in patients with CTS; peloid + splint treatment was more effective than splint treatment alone in pain, functionality and life quality both at after treatment(W2) and one month after treatment (W6). We may suggest peloid as a supplementary therapeutic agent in CTS.

  8. Balneotherapy for chronic low back pain: a randomized, controlled study.

    Science.gov (United States)

    Kesiktas, Nur; Karakas, Sinem; Gun, Kerem; Gun, Nuran; Murat, Sadiye; Uludag, Murat

    2012-10-01

    A large number of treatments were used for patients with chronic low back pain. Frequent episodes have been reported very high. Although balneotherapy was found effective in this disease, there are not well-designed studies. We aimed to determine the effectiveness of balneotherapy versus physical therapy in patients with chronic low back pain. Exercise was added to both treatment programs. Sixty patients with chronic low back pain were randomly divided into two groups. Physical modalities plus exercise were applied to group 1, and group 2 was received balneotherapy plus exercise for ten sessions. The following parameters were measured: visual analogue scale at rest and movement for pain, paracetamol dose, manual muscle test for lumber muscles, modified Schoeber' test, Oswestry disability index, and Short-Form 36 at the beginning and end of the therapies and at the 3 months follow-up. The statistical analyses were performed using the SPSS 10.0 program. Both groups achieved significant improvements within themselves. But balneotherapy groups were improved at back extensor muscle test (P Balneotherapy combined with exercise therapy had advantages than therapy with physical modalities plus exercise in improving quality of life and flexibility of patients with chronic low back pain.

  9. Application of the random coil index to studying protein flexibility

    Energy Technology Data Exchange (ETDEWEB)

    Berjanskii, Mark V.; Wishart, David S. [University of Alberta, Department of Computing Science (Canada)], E-mail: david.wishart@ualberta.ca

    2008-01-15

    Protein flexibility lies at the heart of many protein-ligand binding events and enzymatic activities. However, the experimental measurement of protein motions is often difficult, tedious and error-prone. As a result, there is a considerable interest in developing simpler and faster ways of quantifying protein flexibility. Recently, we described a method, called Random Coil Index (RCI), which appears to be able to quantitatively estimate model-free order parameters and flexibility in protein structural ensembles using only backbone chemical shifts. Because of its potential utility, we have undertaken a more detailed investigation of the RCI method in an attempt to ascertain its underlying principles, its general utility, its sensitivity to chemical shift errors, its sensitivity to data completeness, its applicability to other proteins, and its general strengths and weaknesses. Overall, we find that the RCI method is very robust and that it represents a useful addition to traditional methods of studying protein flexibility. We have implemented many of the findings and refinements reported here into a web server that allows facile, automated predictions of model-free order parameters, MD RMSF and NMR RMSD values directly from backbone {sup 1}H, {sup 13}C and {sup 15}N chemical shift assignments. The server is available at http: //wishart.biology.ualberta.ca/rcihttp://wishart.biology.ualberta.ca/rci.

  10. Efficacy of Arthroscopic Teaching Methods: A Prospective Randomized Controlled Study.

    Science.gov (United States)

    Robinson, Luke; Spanyer, Jonathon; Yenna, Zachary; Burchell, Patrick; Garber, Andrew; Riehl, John

    Arthroscopic education research recently has been focused on the use of skills labs to facilitate resident education and objective measure development to gauge technical skill. This study evaluates the effectiveness of three different teaching methods. Medical students were randomized into three groups. The first group received only classroom-based lecture. The second group received the same lecture and 28 minutes of lab-based hands-off arthroscopy instruction using a cadaver and arthroscopy setup. The final group received the same lecture and 7 minutes of hands-on arthroscopy instruction in the lab on a cadaver knee. The arthroscopic knee exam that followed simulated a diagnostic knee exam and subjects were measured on task completion and by the number of look downs. The number of look downs and the number of tasks completed did not achieve statistical significance between groups. Posttest survey results revealed that the hands-on group placed significantly more value on their educational experience as compared with the other two groups. (Journal of Surgical Orthopaedic Advances.

  11. Comparison of ultrasonic shears and traditional suture ligature for vaginal hysterectomy: randomized controlled trial.

    Science.gov (United States)

    Fitz-Gerald, Alison Louise; Tan, Jason; Chan, Kok-Weng; Polyakov, Alex; Edwards, Geoff N; Najjar, Haider; Tsaltas, Jim; Vollenhoven, Beverley

    2013-01-01

    To compare operating time, intraoperative blood loss, postoperative analgesia, and length of hospital stay using ultrasonic shears vs traditional suture ligature in vaginal hysterectomy. Randomized controlled trial (Canadian Task Force classification I). Gynecology units within a single health network, university hospital. Forty women requiring vaginal hysterectomy because of benign disease. Vaginal hysterectomy performed using either ultrasonically activated shears (USS) or traditional suture ligatures. Twenty-one patients were randomized to the USS arm, and 19 patients to the traditional suture ligature arm. Patient characteristics were comparable. Mean (SD) hysterectomy time and was similar in both the USS and traditional arms, 28.66 (4.0) minutes vs 32.37 (3.18) minutes (p = .47), as was total operating time, 97.38 (8.9) minutes vs 91.63 (7.69) minutes (p = .63). Operative blood loss was significantly decreased in the USS group: 62.63 (12.46) mL vs 136.05 (21.54) mL (p = .006). There was, however, no significant change in hemoglobin concentration between the 2 groups: 19.53 (1.79) g/L vs -16.72 (2.5) g/L. There was no significant difference in mean oxycodone use: 9.29 (2.66) mg vs 8.06 (3.19) mg (p = .77). Length of hospital stay was similar in both groups: 58.98 (3.27) hours vs 60.05 (6.48) hours (p = .88). There was no significant difference in overall complication rates between the groups. Although the Harmonic scalpel system, compared with the traditional suture ligation method, seems to be a safe alternative for securing the pedicles in vaginal hysterectomy, it offers no benefit insofar as operative time, reduction in clinically significant blood loss, and analgesic requirements. Copyright © 2013 AAGL. Published by Elsevier Inc. All rights reserved.

  12. A randomized comparison of different ventilator strategies during thoracotomy for pulmonary resection.

    Science.gov (United States)

    Maslow, Andrew D; Stafford, Todd S; Davignon, Kristopher R; Ng, Thomas

    2013-07-01

    Protective lung ventilation is reported to benefit patients with acute respiratory distress syndrome. It is not known whether protective lung ventilation is also beneficial to patients undergoing single-lung ventilation for elective pulmonary resection. In an institutional review board-approved prospective randomized trial, 34 patients undergoing elective pulmonary resection requiring single-lung ventilation were enrolled. Informed consent was obtained. Patients were randomized to 1 of 2 groups: (1) high tidal volume (Hi-TV) of 10 mL/kg, rate of 7 breaths/min, and zero positive end-expiratory pressure or (2) low tidal volume (Lo-TV) of 5 mL/kg, rate of 14 breaths/min, and 5 cmH2O positive end-expiratory pressure. Ventilator settings were continued during both double- and single-lung ventilation. Pulmonary functions, hemodynamics, and postoperative outcomes were recorded. Patient demographics, operative characteristics, intraoperative hemodynamics, and postoperative pain and sedation scores were similar between the 2 groups. During most time periods, airway pressures (peak and plateau) were significantly higher in the Hi-TV group; however, plateau pressures remained less than 30 cmH2O at all times for all patients. The Hi-TV group had significantly lower arterial carbon dioxide tension, less arterial carbon dioxide tension-end-tidal carbon dioxide gradient, lower alveolar dead space ratio, and higher dynamic pulmonary compliance. There were no differences in postoperative morbidity and hospital days between the 2 groups, but atelectasis scores on postoperative days 1 and 2 were lower in the Hi-TV group. The use of Hi-TV during single-lung ventilation for pulmonary resection resulted in no increase in morbidity and was associated with less hypercarbia, less dead space ventilation, better dynamic compliance, and less postoperative atelectasis. Copyright © 2013 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

  13. Impact of diet on the efficacy of insulin lispro mix 25 and insulin lispro mix 50 as starter insulin in East Asian patients with type 2 diabetes: Subgroup analysis of the Comparison Between Low Mixed Insulin and Mid Mixed Insulin as Starter Insulin For Patients with Type 2 Diabetes Mellitus (CLASSIFY Study) randomized trial.

    Science.gov (United States)

    Chen, Wei; Qian, Lei; Watada, Hirotaka; Li, Peng Fei; Iwamoto, Noriyuki; Imori, Makoto; Yang, Wen Ying

    2017-01-01

    The pathophysiology of diabetes differs between Asian and Western patients in many ways, and diet is a primary contributor. The present study examined the effect of diet on the efficacy of 25% insulin lispro/75% insulin lispro protamine suspension (LM25) and 50% insulin lispro/50% insulin lispro protamine suspension (LM50) as starter insulin in Chinese and Japanese patients with type 2 diabetes and inadequate glycemic control with oral antidiabetic medication. This was a predefined subgroup analysis of a phase 4, open-label, 26-week, parallel-arm, randomized (computer-generated random sequence) trial (21 January 2013 to 22 August 2014). Nutritional intake was assessed from food records kept by participants before study drug administration. Outcomes assessed were changes from baseline in self-monitored blood glucose, 1,5-anhydroglucitol and glycated hemoglobin. In total, 328 participants were randomized to receive twice-daily LM25 (n = 168) or LM50 (n = 160). Median daily nutritional intake (by weight and percentage of total energy) was 230.8 g of carbohydrate (54%), 56.5 g of fat (31%) and 66 g of protein (15%). Improvements in self-monitored blood glucose were significantly greater (P ≤ 0.028) in the LM50 group than in the LM25 group, regardless of nutritional intake. When carbohydrate (by weight or percentage energy) or fat (by weight) intake exceeded median levels, LM50 was significantly more efficacious than LM25 (P ≤ 0.026) in improving 1,5-anhydroglucitol and glycated hemoglobin. Glycemic control improved in both LM25 and LM50 groups, but LM50 was significantly more efficacious under certain dietary conditions, particularly with increased carbohydrate intake. © 2016 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.

  14. Randomized comparison of operator radiation exposure comparing transradial and transfemoral approach for percutaneous coronary procedures: rationale and design of the minimizing adverse haemorrhagic events by TRansradial access site and systemic implementation of angioX – RAdiation Dose study (RAD-MATRIX)

    International Nuclear Information System (INIS)

    Sciahbasi, Alessandro; Calabrò, Paolo; Sarandrea, Alessandro; Rigattieri, Stefano; Tomassini, Francesco; Sardella, Gennaro; Zavalloni, Dennis; Cortese, Bernardo; Limbruno, Ugo; Tebaldi, Matteo; Gagnor, Andrea; Rubartelli, Paolo; Zingarelli, Antonio; Valgimigli, Marco

    2014-01-01

    Background: Radiation absorbed by interventional cardiologists is a frequently under-evaluated important issue. Aim is to compare radiation dose absorbed by interventional cardiologists during percutaneous coronary procedures for acute coronary syndromes comparing transradial and transfemoral access. Methods: The randomized multicentre MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX) trial has been designed to compare the clinical outcome of patients with acute coronary syndromes treated invasively according to the access site (transfemoral vs. transradial) and to the anticoagulant therapy (bivalirudin vs. heparin). Selected experienced interventional cardiologists involved in this study have been equipped with dedicated thermoluminescent dosimeters to evaluate the radiation dose absorbed during transfemoral or right transradial or left transradial access. For each access we evaluate the radiation dose absorbed at wrist, at thorax and at eye level. Consequently the operator is equipped with three sets (transfemoral, right transradial or left transradial access) of three different dosimeters (wrist, thorax and eye dosimeter). Primary end-point of the study is the procedural radiation dose absorbed by operators at thorax. An important secondary end-point is the procedural radiation dose absorbed by operators comparing the right or left radial approach. Patient randomization is performed according to the MATRIX protocol for the femoral or radial approach. A further randomization for the radial approach is performed to compare right and left transradial access. Conclusions: The RAD-MATRIX study will probably consent to clarify the radiation issue for interventional cardiologist comparing transradial and transfemoral access in the setting of acute coronary syndromes

  15. Randomized comparison of operator radiation exposure comparing transradial and transfemoral approach for percutaneous coronary procedures: rationale and design of the minimizing adverse haemorrhagic events by TRansradial access site and systemic implementation of angioX – RAdiation Dose study (RAD-MATRIX)

    Energy Technology Data Exchange (ETDEWEB)

    Sciahbasi, Alessandro, E-mail: alessandro.sciahbasi@fastwebnet.it [Interventional Cardiology, Sandro Pertini Hospital – ASL RMB, Rome (Italy); Calabrò, Paolo [Division of Cardiology - Department of Cardio-Thoracic Sciences - Second University of Naples (Italy); Sarandrea, Alessandro [HSE Management, Rome (Italy); Rigattieri, Stefano [Interventional Cardiology, Sandro Pertini Hospital – ASL RMB, Rome (Italy); Tomassini, Francesco [Department of Cardiology, Infermi Hospital, Rivoli (Italy); Sardella, Gennaro [La Sapienza University, Rome (Italy); Zavalloni, Dennis [UO Emodinamica e Cardiologia Invasiva, IRCCS, Istituto Clinico Humanitas, Rozzano (Italy); Cortese, Bernardo [Interventional Cardiology, Fatebenefratelli Hospital, Milan (Italy); Limbruno, Ugo [Cardiology Unit, Misericordia Hospital, Grosseto (Italy); Tebaldi, Matteo [Cardiology Department, University of Ferrara, Department of Cardiology (Italy); Gagnor, Andrea [Department of Cardiology, Infermi Hospital, Rivoli (Italy); Rubartelli, Paolo [Villa Scassi Hospital, Genova (Italy); Zingarelli, Antonio [San Martino Hospital, Genova (Italy); Valgimigli, Marco [Thoraxcenter, Rotterdam (Netherlands)

    2014-06-15

    Background: Radiation absorbed by interventional cardiologists is a frequently under-evaluated important issue. Aim is to compare radiation dose absorbed by interventional cardiologists during percutaneous coronary procedures for acute coronary syndromes comparing transradial and transfemoral access. Methods: The randomized multicentre MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX) trial has been designed to compare the clinical outcome of patients with acute coronary syndromes treated invasively according to the access site (transfemoral vs. transradial) and to the anticoagulant therapy (bivalirudin vs. heparin). Selected experienced interventional cardiologists involved in this study have been equipped with dedicated thermoluminescent dosimeters to evaluate the radiation dose absorbed during transfemoral or right transradial or left transradial access. For each access we evaluate the radiation dose absorbed at wrist, at thorax and at eye level. Consequently the operator is equipped with three sets (transfemoral, right transradial or left transradial access) of three different dosimeters (wrist, thorax and eye dosimeter). Primary end-point of the study is the procedural radiation dose absorbed by operators at thorax. An important secondary end-point is the procedural radiation dose absorbed by operators comparing the right or left radial approach. Patient randomization is performed according to the MATRIX protocol for the femoral or radial approach. A further randomization for the radial approach is performed to compare right and left transradial access. Conclusions: The RAD-MATRIX study will probably consent to clarify the radiation issue for interventional cardiologist comparing transradial and transfemoral access in the setting of acute coronary syndromes.

  16. Randomized comparison of operator radiation exposure comparing transradial and transfemoral approach for percutaneous coronary procedures: rationale and design of the minimizing adverse haemorrhagic events by TRansradial access site and systemic implementation of angioX - RAdiation Dose study (RAD-MATRIX).

    Science.gov (United States)

    Sciahbasi, Alessandro; Calabrò, Paolo; Sarandrea, Alessandro; Rigattieri, Stefano; Tomassini, Francesco; Sardella, Gennaro; Zavalloni, Dennis; Cortese, Bernardo; Limbruno, Ugo; Tebaldi, Matteo; Gagnor, Andrea; Rubartelli, Paolo; Zingarelli, Antonio; Valgimigli, Marco

    2014-06-01

    Radiation absorbed by interventional cardiologists is a frequently under-evaluated important issue. Aim is to compare radiation dose absorbed by interventional cardiologists during percutaneous coronary procedures for acute coronary syndromes comparing transradial and transfemoral access. The randomized multicentre MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX) trial has been designed to compare the clinical outcome of patients with acute coronary syndromes treated invasively according to the access site (transfemoral vs. transradial) and to the anticoagulant therapy (bivalirudin vs. heparin). Selected experienced interventional cardiologists involved in this study have been equipped with dedicated thermoluminescent dosimeters to evaluate the radiation dose absorbed during transfemoral or right transradial or left transradial access. For each access we evaluate the radiation dose absorbed at wrist, at thorax and at eye level. Consequently the operator is equipped with three sets (transfemoral, right transradial or left transradial access) of three different dosimeters (wrist, thorax and eye dosimeter). Primary end-point of the study is the procedural radiation dose absorbed by operators at thorax. An important secondary end-point is the procedural radiation dose absorbed by operators comparing the right or left radial approach. Patient randomization is performed according to the MATRIX protocol for the femoral or radial approach. A further randomization for the radial approach is performed to compare right and left transradial access. The RAD-MATRIX study will probably consent to clarify the radiation issue for interventional cardiologist comparing transradial and transfemoral access in the setting of acute coronary syndromes. Copyright © 2014 Elsevier Inc. All rights reserved.

  17. Stochastic spectral Galerkin and collocation methods for PDEs with random coefficients: A numerical comparison

    KAUST Repository

    Bäck, Joakim

    2010-09-17

    Much attention has recently been devoted to the development of Stochastic Galerkin (SG) and Stochastic Collocation (SC) methods for uncertainty quantification. An open and relevant research topic is the comparison of these two methods. By introducing a suitable generalization of the classical sparse grid SC method, we are able to compare SG and SC on the same underlying multivariate polynomial space in terms of accuracy vs. computational work. The approximation spaces considered here include isotropic and anisotropic versions of Tensor Product (TP), Total Degree (TD), Hyperbolic Cross (HC) and Smolyak (SM) polynomials. Numerical results for linear elliptic SPDEs indicate a slight computational work advantage of isotropic SC over SG, with SC-SM and SG-TD being the best choices of approximation spaces for each method. Finally, numerical results corroborate the optimality of the theoretical estimate of anisotropy ratios introduced by the authors in a previous work for the construction of anisotropic approximation spaces. © 2011 Springer.

  18. Random-Number Generator Validity in Simulation Studies: An Investigation of Normality.

    Science.gov (United States)

    Bang, Jung W.; Schumacker, Randall E.; Schlieve, Paul L.

    1998-01-01

    The normality of number distributions generated by various random-number generators were studied, focusing on when the random-number generator reached a normal distribution and at what sample size. Findings suggest the steps that should be followed when using a random-number generator in a Monte Carlo simulation. (SLD)

  19. Comparison of the Otto Bock solid ankle cushion heel foot with wooden keel to the low-cost CR-Equipements™ solid ankle cushion heel foot with polypropylene keel: A randomized prospective double-blind crossover study assessing patient satisfaction and energy expenditure.

    Science.gov (United States)

    Lacraz, Alain; Armand, Stéphane; Turcot, Katia; Carmona, Gorki; Stern, Richard; Borens, Olivier; Assal, Mathieu

    2017-06-01

    The International Committee of the Red Cross supports a worldwide program of prosthetic fitting and rehabilitation. In this context, a prosthetic foot was developed and widely distributed in least developed countries. Prospective, randomized, double-blind, controlled study. To compare patient satisfaction and energy expenditure during ambulation between a low-cost prosthetic foot designed with a polypropylene keel (CR-Equipements ™ solid ankle cushion heel, International Committee of the Red Cross) to a well-recognized solid ankle cushion heel foot with a wooden keel (solid ankle cushion heel foot, Otto Bock). A total of 15 participants with unilateral transtibial amputation were evaluated using the two prosthetic feet in a randomized prospective double-blind crossover study. Main outcomes were patient satisfaction questionnaires (Satisfaction with Prosthesis Questionnaire and prosthetic foot satisfaction) and energy expenditure (oxygen consumption-mL/kg/min, oxygen cost-mL/kg/m, and heart rate-bpm). There were no significant differences between the two prosthetic feet for satisfaction and energy expenditure. The low-cost solid ankle cushion heel foot with polypropylene keel provides comparable satisfaction and similar energy expenditure as the solid ankle cushion heel foot with wooden keel. Clinical relevance The results of this study support the application and widespread use of the CR-Equipements ™ solid ankle cushion heel foot. From a cost-effectiveness standpoint, patients are well satisfied and exhibit similar outcomes at a substantially lower cost.

  20. Sugammadex versus neostigmine in pediatric patients: a prospective randomized study

    Directory of Open Access Journals (Sweden)

    Turhan Kara

    2014-12-01

    Full Text Available Background and objectives: Acetylcholinesterase inhibitors may cause postoperative residual curarization when they are used for reversal of neuromuscular blockade. Sugammadex reverses neuromuscular blockade by chemical encapsulation and is not associated with the side effects that may occur with the use of anticholinesterase agents. Because of increased outpatient surgical procedures postoperative residual curarization and rapid postoperative recovery have a greater importance in the pediatric patient population. The aim of this study was to compare the efficacy of sugammadex and neostigmine on reversing neuromuscular blockade in pediatric patients undergoing outpatient surgical procedures. Methods: 80 patients, aged 2-12 years, scheduled for outpatient surgery were enrolled in this randomized prospective study. Neuromuscular blockade was achieved with 0.6 mgkg−1 rocuronium and monitorized with train-of-four. Group RN (n = 40 received 0.03 mgkg−1 neostigmine, Group RS (n = 40 received 2 mgkg−1 sugammadex for reversal of rocuronium. Extubation time (time from the reversal of neuromuscular blockade to extubation, train-of-four ratio during this time, time to reach train-of-four > 0.9, and probable complications were recorded. Results: There was no significant difference between the patients' characteristics. Extubation time and time to reach train-of-four > 0.9 were significantly higher in Group RN (p = 0.001, p = 0.002. Train-of-four at the time of neostigmine/sugammadex injection in Group RN were significantly higher than in the RS group (p = 0.020. Extubation train-of-four ratio was significantly lower in Group RN (p = 0.002. Conclusion: Sugammadex provides safer extubation with a shorter recovery time than neostigmine in pediatric patients undergoing outpatient surgical procedures.

  1. Combining drug and music therapy in patients with moderate Alzheimer's disease: a randomized study.

    Science.gov (United States)

    Giovagnoli, Anna Rita; Manfredi, Valentina; Schifano, Letizia; Paterlini, Chiara; Parente, Annalisa; Tagliavini, Fabrizio

    2018-06-01

    Alzheimer's disease (AD) can impair language, but active music therapy (AMT) and memantine (M) can improve communication. This study aimed to clarify whether adding AMT to M may improve language in comparison with drugs alone in patients with moderate AD on stable therapy with acetylcholinesterase inhibitors (AchEI). Forty-five AD patients treated with stable dose of AchEI were randomized to receive AMT plus M 20 mg/day or M 20 mg/day for 24 weeks. The Severe Impairment Battery-Language (SIB-l), SIB, Mini Mental State Examination, Neuropsychiatric Inventory (NPI), Lubben Social Network Scale, Activities of Daily Living, and Instrumental Activities of Daily Living scores at baseline and 12 and 24 weeks assessed language (primary variable) and overall cognitive, psycho-behavior, social, and functional aspects (secondary variables). The SIB-l showed a stabilization of the baseline condition in both groups, in the absence of between-group differences. The NPI depression and appetite scores significantly improved in the M-AMT group. Moreover, significantly less patients in the M-AMT group than those in the M group showed worsening of the NPI total score. Daily activities, social relationships, and overall cognitive performance did not deteriorate. In patients with moderate AD, AMT added to pharmacotherapy has no further benefits for language in comparison with pharmacotherapy alone. However, this integrated treatment can improve the psycho-behavioral profile.

  2. Treatment of radiation enteritis: a comparison study

    International Nuclear Information System (INIS)

    Loiudice, T.A.; Lang, J.A.

    1983-01-01

    Twenty-four patients with severe radiation injury to the small bowel seen over a 4-year period were randomized to four treatment groups: 1) methylprednisolone 80 mg intravenously plus Vivonex-HN, 2 L/day po, 2) methylprednisolone 80 mg intravenously plus total parenteral nutrition, 2.5 L/day, 3) total parenteral nutrition, 2.5 L/day, and 4) Vivonex-HN, 2 L/day po. Patients received nothing by mouth except water in groups II and III, and only Vivonex-HN in groups I and IV. Patients were treated for 8-wk periods. Improvement was gauged by overall nutritional assessment measurements, nitrogen balance data and by radiological and clinical parameters. No significant difference between groups I, II, III, and IV could be found for age, sex, mean radiation dosage, time of onset after radiation therapy, or initial nutritional assessment data. Differences statistically could be found between groups II and III and I and IV regarding nutritional assessment data, nitrogen balance, radiographic and clinical parameters after therapy, with marked improvement noted in groups II and III. We conclude that a treatment regimen consisting of total parenteral nutrition and bowel rest is beneficial in the treatment of radiation enteritis. Methylprednisolone appears to enhance this effect and indeed, may be responsible for a longer lasting response

  3. Comparison of Sucralfate and Hydrocortisone Enemas in Treatment of Active Ulcerative Proctitis; A Double-Blind Randomized ClinicalL Trial

    Directory of Open Access Journals (Sweden)

    Mohammad Reza Javadi

    2003-08-01

    Full Text Available Sucralfate enema has been proposed and investigated in treatment of ulcerative proctitis, but its efficacy is still a matter of debate. Hydrocortisone enema is still an established drug in treatment of ulcerative proctitis. This study was designed to compare the effect of sucralfate enema with hydrocortisone enema. Patients with active sigmoidoscopic and histologic features of ulcerative proctitis were included. All patients had clinical manifestations of proctitis for at least four weeks prior to the study and had negative parasitic stool culture. The total of 25 patients entered the study. They were randomly divided in two groups; group I (n =14 and group II (n = 11 who received sucralfate and hydrocortisone enemas respectively for 4 weeks. Both groups had a significant improvement in clinical features, histologic activity and sigmoidoscopic evaluation in comparison with the baseline. Furthermore there was no significant differences between the two groups concerning mean changes of clinical, sigmoidoscopic, and histologic grading, after treatment. Considering the low cost and minimal adverse effects of sucralfate, and almost equal efficacy in comparison with hydrocortisone enema, its usage can be recommended.

  4. A randomized comparison between neurostimulation and ultrasound-guided lateral femoral cutaneous nerve block.

    Science.gov (United States)

    Gupta, Gaurav; Radhakrishna, Mohan; Tamblyn, Isaac; Tran, D Q; Besemann, Markus; Thonnagith, Atikun; Elgueta, Maria Francisca; Robitaille, Marie Eve; Finlayson, Roderick J

    2017-01-01

    This prospective, randomized trial compared neurostimulation (NS) and ultrasound (US) guided lateral femoral cutaneous nerve (LFCN) block. We hypothesized that US would result in a shorter total anesthesia-related time (sum of performance and onset times). Twenty-one volunteers were enrolled. The right lower limb was randomized to an NS- or US-guided LFCN block. The alternate technique was employed for the left lower limb. With NS, paresthesias were sought in the lateral thigh at a stimulatory threshold of 0.6 mA (pulse width=0.3 ms; frequency=2 Hz) or lower. With US, local anesthetic was deposited under the inguinal ligament, ventral to the iliopsoas muscle. In both groups, 5 mL of lidocaine 2% were used to anesthetize the nerve. During the procedure of the block, the performance time and number of needle passes were recorded. Subsequently, a blinded observer assessed sensory block in the lateral thigh every minute until 20 minutes. Success was defined as loss of pinprick sensation at a point midway between the anterior superior iliac spine and the lateral knee line. The blinded observer also assessed the areas of sensory block in the anterior, medial, lateral, and posterior aspects of the thigh and mapped this distribution onto a corresponding grid. Both modalities provided comparable success rates (76.2%-95.2%), performance times (162.1 to 231.3 seconds), onset times (300.0 to 307.5 seconds) and total anesthesia related-times (480.1 to 554.0 seconds). However US required fewer needle passes (3.2±2.9 vs 9.5±12.2; P=.009). There were no intergroup differences in terms of the distribution of the anesthetized cutaneous areas. However considerable variability was encountered between individuals and between the 2 sides of a same subject. The most common areas of sensory loss included the central lateral two-eighths anteriorly and the central antero-inferior three-eighths laterally. Ultrasound guidance and NS provide similar success rates and total anesthesia

  5. A Randomized Comparison Between Ultrasound- and Fluoroscopy-Guided Sacral Lateral Branch Blocks.

    Science.gov (United States)

    Finlayson, Roderick J; Etheridge, John-Paul B; Elgueta, Maria Francisca; Thonnagith, Atikun; De Villiers, Frederick; Nelems, Bill; Tran, De Q

    This randomized trial compared ultrasound (US)- and fluoroscopy-guided sacral lateral branch (SLB) blocks. We hypothesized that US would require a shorter performance time. Forty patients who required unilateral sacral lateral branch blocks for chronic low back pain were randomized to US or fluoroscopy guidance. Before the performance of the assigned block, an investigator who was not involved in patient care carried out baseline analgesic testing. With US, the dorsal sacroiliac ligament, the sacroiliac joint, and the interosseous ligament were probed with a 22-gauge block needle. The patient was asked to rate the level of discomfort using an 11-point numerical rating scale.After the analgesic test, attending anesthesiologists or supervised trainees carried out the SLB blocks. The local anesthetic agent (lidocaine 2%) was identical in all subjects. In the US group, local anesthetic (1.5 mL) was first injected on the lateral crest at the mid-point between S2 and S3. Subsequently, 2 more injections of 0.5 mL were carried out on the lateral crest, immediately cephalad to S2 and at the S1 level. In the fluoroscopy group, SLB blocks were performed according to a previously described 17-injection technique, which involves 9 skin entry sites and the targeting of the L5 posterior root and S1-S3 sacral lateral branches. A 0.4-mL volume of local anesthetic was deposited at each target point. The performance time, number of needle passes, and the incidence of vascular breach were recorded during the performance of the block.Twenty minutes after the end of local anesthetic injection, the same investigator who performed preblock analgesic testing carried out postblock testing in an identical manner. Compared with fluoroscopy, the US technique was associated with a shorter performance time (267.5 ± 99.3 vs 628.7 ± 120.3 seconds; P < 0.001), fewer needle passes and a lower incidence of vascular breach (0 vs 10 occurrences; P = 0.001). However, the block effect (ie, the

  6. Comparison of clinical effectiveness of laser acupuncture and amitriptyline in diabetic peripheral neuropathy (DPN): a sham controlled randomized clinical trial

    Science.gov (United States)

    Hassan Khan, Imran; Anwar, Shahzad; Hanif, Asif; Ayub, Muhammad; Jamil Raja, Arsalan

    2014-02-01

    Background: Painful neuropathy is a very common complication in diabetic patients. Various treatment strategies like manual therapies, conservative management, drug therapy and exercise have been opted for this problem. Studies have shown clinical effectiveness of laser acupuncture as well. On the other hand, Amitryptaline is also a commonly used treatment for this disease. We aim to compare the efficacy of both treatments. Objective: To assess the effect of laser acupuncture in patients suffering from painful diabetic neuropathy and its comparison with standard of care. Patients and Method: This study was conducted in Diabetic and Endocrine Management Center (DEMC) Lahore General Hospital, Lahore, Pakistan. A randomized control trial (RCT) was opted and a total of 164 patients were chosen using Non-probability purposive sampling technique. Pain was graded by using a patient friendly Visual Analogue Score (VAS), scoring from 0 to 10. Treatment was done involving organized fortnightly follow ups. Data of all patients was recorded on Performa and was entered and analyzed for descriptive statistics in PASW 18 (IBM®. SPSS). Results: A total of 164 subjects were included in the study who were subdivided into three groups labeled as A, B and C for laser therapy treatment, amitryptaline treatment and controls respectively. The mean age of subjects was 51.54+/-10.46 in Group A, 49.38+/-10.56 in Group B and 51.70+/-11.43 in Group C. The difference of mean ages in all study groups was statistically insignificant (p-value= 0.469). The average pain score in patients who received laser therapy was 5.95+/-0.91 before treatment, whereas after treatment it was 4.31+/-0.98. The mean pain score in subjects having Amitryptaline before starting the treatment was 6.87+/-0.71 and after treatment, it was 6.23+/-0.98. The mean score for daily life activities in subjects who received laser therapy was 9.562.37 before treatment, while after treatment it was 7.56+/-1.54. The average score

  7. A prospective randomized peri- and post-operative comparison of the minimally invasive anterolateral approach versus the lateral approach

    OpenAIRE

    Stefan Landgraeber; Henning Quitmann; Sebastian Güth; Marcel Haversath; Wojciech Kowalczyk; Andrés Kecskeméthy; Hansjörg Heep; Marcus Jäger

    2013-01-01

    There is still controversy as to whether minimally invasive total hip arthroplasty enhances the postoperative outcome. The aim of this study was to compare the outcome of patients who underwent total hip replacement through an anterolateral minimally invasive (MIS) or a conventional lateral approach (CON). We performed a randomized, prospective study of 75 patients with primary hip arthritis, who underwent hip replacement through the MIS (n=36) or CON (n=39) approach. The Western Ontario and ...

  8. Comparison on electrically pumped random laser actions of hydrothermal and sputtered ZnO films

    International Nuclear Information System (INIS)

    Wang, Canxing; Jiang, Haotian; Li, Yunpeng; Ma, Xiangyang; Yang, Deren

    2013-01-01

    Random lasing (RL) in polycrystalline ZnO films is an intriguing research subject. Here, we have comparatively investigated electrically pumped RL behaviors of two metal-insulator-semiconductor structured devices using the hydrothermal and sputtered ZnO films as the semiconductor components, i.e., the light-emitting layers, respectively. It is demonstrated that the device using the hydrothermal ZnO film exhibits smaller threshold current and larger output optical power of the electrically pumped RL. The morphological characterization shows that the hydrothermal ZnO film is somewhat porous and is much rougher than the sputtered one, suggesting that in the former stronger multiple light scattering can occur. Moreover, the photoluminescence characterization indicates that there are fewer defects in the hydrothermal ZnO film than in the sputtered one, which means that the photons can pick up larger optical gain through stimulated emission in the hydrothermal ZnO film. Therefore, it is believed that the stronger multiple light scattering and larger optical gain contribute to the improved performance of the electrically pumped RL from the device using the hydrothermal ZnO film

  9. Randomized comparison of sirolimus eluting, and biolimus eluting bioresorbable polymer stents

    DEFF Research Database (Denmark)

    Andreasen, Lene N; Holm, Niels R; Balleby, Ida R

    2018-01-01

    -inferiority (Δ = 0.60 mm2) of the Orsiro DES to the Nobori DES for the primary endpoint of mean extra stent lumen (ESL) i.e. vessel lumen outside the stent at 13-month follow-up. We randomized 124 patients to Orsiro (n = 60) or Nobori (n = 64). Due to a difference in the one-sided 95%-confidence interval of 0.......26 mm2, but increased to 0.82 mm2 after appropriate log-transformation, it could not be rejected that Orsiro exceeded the non-inferiority limit. Testing for superiority, Orsiro had a significantly larger mean ESL at follow-up (Orsiro: 0.11 mm2 [0.02;0.30] mm2, Nobori: 0.03 mm2 [0.00;0.17] mm2, P = 0.......04). Stent strut coverage was, Orsiro: 97.6 % [93.8;99.4]%, and Nobori: 96.3 % [90.5;98,6]% (P = 0.13). Conclusion: Orsiro DES had a significantly larger mean ESL at follow-up and it could not be excluded that Orsiro exceeded the limit for non-inferiority. Nobori DES had a more heterogeneous distribution...

  10. Randomized comparison of oral misoprostol and oxytocin for labor induction in term prelabor membrane rupture.

    Science.gov (United States)

    Butt, K D; Bennett, K A; Crane, J M; Hutchens, D; Young, D C

    1999-12-01

    To compare labor induction intervals between oral misoprostol and intravenous oxytocin in women who present at term with premature rupture of membranes. One hundred eight women were randomly assigned to misoprostol 50 microg orally every 4 hours as needed or intravenous oxytocin. The primary outcome measure was time from induction to vaginal delivery. Sample size was calculated using a two-tailed alpha of 0.05 and power of 80%. Baseline demographic data, including maternal age, gestation, parity, Bishop score, birth weight, and group B streptococcal status, were similar. The mean time +/-standard deviation to vaginal birth with oral misoprostol was 720+/-382 minutes compared with 501+/-389 minutes with oxytocin (P = .007). The durations of the first, second, and third stages of labor were similar. There were no differences in maternal secondary outcomes, including cesarean birth (eight and seven, respectively), infection, maternal satisfaction with labor, epidural use, perineal trauma, manual placental removal, or gastrointestinal side effects. Neonatal outcomes including cord pH, Apgar scores, infection, and admission to neonatal intensive care unit were not different. Although labor induction with oral misoprostol was effective, oxytocin resulted in a shorter induction-to-delivery interval. Active labor intervals and other maternal and neonatal outcomes were similar.

  11. Acupuncture intervention in ischemic stroke: a randomized controlled prospective study.

    Science.gov (United States)

    Shen, Peng-Fei; Kong, Li; Ni, Li-Wei; Guo, Hai-Long; Yang, Sha; Zhang, Li-Li; Zhang, Zhi-Long; Guo, Jia-Kui; Xiong, Jie; Zhen, Zhong; Shi, Xue-Min

    2012-01-01

    Stroke is one of the most common causes of death and few pharmacological therapies show benefits in ischemic stroke. In this study, 290 patients aged 40-75 years old with first onset of acute ischemic stroke (more than 24 hours but within 14 days) were treated with standard treatments, and then were randomly allocated into an intervention group (treated with resuscitating acupuncture) and a control group (treated using sham-acupoints). Primary outcome measures included Barthel Index (BI), relapse and death up to six months. For the 290 patients in both groups, one case in the intervention group died, and two cases in the control group died from the disease (p = 0.558). Six patients of the 144 cases in the intervention group had relapse, whereas 34 of 143 patients had relapse in the control group (p two groups, respectively (p two groups for the National Institute of Health Stroke Scale (NIHSS), not at two weeks (7.03 ± 3.201 vs. 8.13 ± 3.634; p = 0.067), but at four weeks (4.15 ± 2.032 vs. 6.35 ± 3.131, p Stroke Scale (CSS) at four weeks showed more improvement in the intervention group than that in the control group (9.40 ± 4.51 vs. 13.09 ± 5.80, p Stroke Specific Quality of Life Scale (SS-QOL) at six months was higher in the intervention group (166.63 ± 45.70) than the control group (143.60 ± 50.24; p < 0.01). The results of this clinical trial showed a clinically relevant decrease of relapse in patients treated with resuscitating acupuncture intervention by the end of six months, compared with needling at the sham-acupoints. The resuscitating acupuncture intervention could also improve self-care ability and quality of life, evaluated with BI, NIHSS, CSS, Oxford Handicap Scale (OHS), and SS-QOL.

  12. Comparison between herbal medicine and fluoxetine for depression: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Ren, Yi; Zhu, Chenjun; Wu, Jianjun; Zheng, Ruwen; Cao, Huijaun

    2015-10-01

    To evaluate the effectiveness and safety of Chinese herbal medicine (CHM) versus fluoxetine on depression. A systematic review of randomized controlled trials (RCTs). RCT with two parallel groups that compared CHM and fluoxetine on treatment of depression with reported decreased Hamilton Depression Scale (HAMD) and adverse events during treatment were included after searching through six electric-databases. The methodological quality of RCTs was assessed according to the Cochrane risk of bias tool. Meta-analysis was conducted using RevMan 5.3 software with pooled mean difference (MD) or risk ratio (RR) and their 95% confidence interval (CI) if no significant heterogeneity was detected. A SOF table was generated using GRADEPro software to evaluate the overall quality of the evidence. Twenty-six trials with 3294 participants were included in the review. Most of them had high risk of bias during conducting and reporting. The results achieved weak evidence which showed CHM had similar effect to fluoxetine (20mg/day) on relieving depression according to HAMD assessment (for primary depression: MD=-0.08, 95%CI -0.98-0.82; for secondary depression: MD=-0.36, 95%CI -1.55-0.83), but fewer incidences of adverse events than the drug (for primary depression: RR=0.31, 95%CI 0.17-0.59; for post-stroke depression: RR=0.04, 95%CI 0.00-0.25). No serious adverse event was found in neither CHM nor fluoxetine group. Due to the poor quality of included trials and the potential publication bias of this review, no confirmed conclusion could be draw to evaluate the effectiveness and safety of CHM for depression compared with fluoxetine. Copyright © 2015 Elsevier Ltd. All rights reserved.

  13. A Randomized Open Label Comparison of the Effects ofRisperidone and Haloperidol on Sexual Function

    Directory of Open Access Journals (Sweden)

    S. Jaber Mousavi

    2009-12-01

    Full Text Available "n Objective: "nSexual dysfunction in patients who take antipsychotics causes adecline in their quality of life and medication acceptance. Considering the restrictions in cross sectional design of many earlier researches, we used a clinical trial aimed at assessing sexual dysfunction by substituting Risperidone, an atypical antipsychotic drug, with Haloperidol, a typical one . "n "n "nMethod: This clinical trial was conducted on 51 patients who had been using Risperidone with a minimum dose of 2 mg/daily for at least 2 months. The patients were randomly divided into 2 groups. The first group continued taking Risperidone, whereas the second group was given Haloperidol. Sexual function prior to and after the drug substitution was assessed using a sexual questionnaire designed to assess four stages of sexual function . "nResults: Compared to those who changed their medication to Haloperidol, the patients who remained on Risperidone therapy suffered from more sexual dysfunction, especially in their tendency towards having sexual activities (P= 0.01, post menstrual sexual activity (P= 0.002, and reaching orgasm in their sexual activities (P= 0.04; however in the Haloperidol group, no significant difference was observed before and after the change in medication . "nConclusion: Although Risperidone and Haloperidol can both disturb patients'sexual function, the side effects of Risperidone are stronger. Hence toprevent the decline of medication acceptance or irregular consumption by patients which may lead to possible relapse, substitution of Risperidone withanother drug with fewer side effects on sexual activities is definitely to the advantage of the patients .

  14. Comparison of 3 different methods of anesthesia before transrectal prostate biopsy: a prospective randomized trial

    International Nuclear Information System (INIS)

    Oebek, C.; Oezkan, B.; Tunc, B.; Can, G.; Yalcin, V.; Solok, V.

    2004-01-01

    Purpose: Periprostatic nerve block (PNB) is the most common anesthesia technique used before prostate biopsy. However, needle punctures for anesthetic infiltration may be painful and cause higher infectious complications. We assessed whether addition of rectal lidocaine gel would improve its efficacy. We also investigated the efficacy and safety of tramadol, a codeine derivative, as a noninvasive method. Materials and Methods: A total of 300 patients who underwent prostate biopsies were randomized into 4 groups of controls, PNB, perianal/intrarectal lidocaine gel plus PNB and tramadol. Pain was assessed with a numeric analog scale. Results: Each group consisted of 75 patients, and there was a statistically significant difference among pain scores (p = 0.001). Mean pain scores were 4.63 for controls, 2.57 for PNB, 2.03 for infiltration plus gel group and 3.11 for tramadol. Pain and discomfort were least in PNB plus gel arm. The difference of pain score between PNB alone and tramadol group did not reach statistical significance. Infectious complications were higher in the combination group, whereas there were no complications with tramadol. Conclusions: Any form of analgesia/anesthesia was superior to none. The combination of PNB plus gel provided significantly better analgesia compared to PNB alone or tramadol. If this can be duplicated in other trials, the combination may be accepted as the new gold standard of anesthesia for prostate biopsy. The efficacy of tramadol was similar to that of PNB, and was free of complications. Therefore, tramadol may have a role before prostate biopsy, which needs to be explored. (author)

  15. Conventional versus computer-navigated TKA: a prospective randomized study.

    Science.gov (United States)

    Todesca, Alessandro; Garro, Luca; Penna, Massimo; Bejui-Hugues, Jacques

    2017-06-01

    The purpose of this study was to assess the midterm results of total knee arthroplasty (TKA) implanted with a specific computer navigation system in a group of patients (NAV) and to assess the same prosthesis implanted with the conventional technique in another group (CON); we hypothesized that computer navigation surgery would improve implant alignment, functional scores and survival of the implant compared to the conventional technique. From 2008 to 2009, 225 patients were enrolled in the study and randomly assigned in CON and NAV groups; 240 consecutive mobile-bearing ultra-congruent score (Amplitude, Valence, France) TKAs were performed by a single surgeon, 117 using the conventional method and 123 using the computer-navigated approach. Clinical outcome assessment was based on the Knee Society Score (KSS), the Hospital for Special Surgery Knee Score and the Western Ontario Mac Master University Index score. Component survival was calculated by Kaplan-Meier analysis. Median follow-up was 6.4 years (range 6-7 years). Two patients were lost to follow-up. No differences were seen between the two groups in age, sex, BMI and side of implantation. Three patients of CON group referred feelings of instability during walking, but clinical tests were all negative. NAV group showed statistical significant better KSS Score and wider ROM and fewer outliers from neutral mechanical axis, lateral distal femoral angle, medial proximal tibial angle and tibial slope in post-operative radiographic assessment. There was one case of early post-operative superficial infection (caused by Staph. Aureus) successfully treated with antibiotics. No mechanical loosening, mobile-bearing dislocation or patellofemoral complication was seen. At 7 years of follow-up, component survival in relation to the risk of aseptic loosening or other complications was 100 %. There were no implant revisions. This study demonstrates superior accuracy in implant positioning and statistical significant

  16. Randomized, Controlled Study of Adderall XR in ADHD

    Directory of Open Access Journals (Sweden)

    J Gordon Millichap

    2002-08-01

    Full Text Available The efficacy and safety of Adderall XR in the treatment of attention deficit/hyperactivity disorder and diurnal variation in responses were assessed by a multicenter, randomized, double-blind, parallel group, placebo-controlled trial at 47 sites, and reported from the Massachusetts General Hospital, Boston, MA.

  17. FIT for FUNCTION: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Richardson, Julie; Tang, Ada; Guyatt, Gordon; Thabane, Lehana; Xie, Feng; Sahlas, Demetrios; Hart, Robert; Fleck, Rebecca; Hladysh, Genevieve; Macrae, Louise

    2018-01-15

    The current state of evidence suggests that community-based exercise programs are beneficial in improving impairment, function, and health status, and are greatly needed for persons with stroke. However, limitations of these studies include risk of bias, feasibility, and cost issues. This single-blinded, randomized controlled trial (RCT) of 216 participants with stroke will compare the effectiveness of a 12-week YMCA community-based wellness program (FIT for FUNCTION) specifically designed for community-dwelling persons with stroke to persons who receive a standard YMCA membership. The primary outcome will be community reintegration using the Reintegration to Normal Living Index at 12 and 24 weeks. Secondary outcomes include measurement of physical activity level using the Rapid Assessment of Physical Activity and accelerometry; balance using the Berg Balance Scale; lower extremity function using the Short Physical Performance Battery; exercise capacity using the 6-min walk test; grip strength and isometric knee extension strength using hand held dynamometry; and health-related quality of life using the European Quality of Life 5-Dimension Questionnaire. We are also assessing cardiovascular health and lipids; glucose and inflammatory markers will be collected following 12-h fast for total cholesterol, insulin, glucose, and glycated hemoglobin. Self-efficacy for physical activity will be assessed with a single question and self-efficacy for managing chronic disease will be assessed using the Stanford 6-item Scale. The Patient Activation Measure will be used to assess the patient's level of knowledge, skill, and confidence for self-management. Healthcare utilization and costs will be evaluated. Group, time, and group × time interaction effects will be estimated using generalized linear models for continuous variables, including relevant baseline variables as covariates in the analysis that differ appreciably between groups at baseline. Cost data will be treated

  18. Efficacy of triplet regimen antiemetic therapy for chemotherapy-induced nausea and vomiting (CINV) in bone and soft tissue sarcoma patients receiving highly emetogenic chemotherapy, and an efficacy comparison of single-shot palonosetron and consecutive-day granisetron for CINV in a randomized, single-blinded crossover study

    International Nuclear Information System (INIS)

    Kimura, Hiroaki; Yamamoto, Norio; Shirai, Toshiharu; Nishida, Hideji; Hayashi, Katsuhiro; Tanzawa, Yoshikazu; Takeuchi, Akihiko; Igarashi, Kentaro; Inatani, Hiroyuki; Shimozaki, Shingo; Kato, Takashi; Aoki, Yu; Higuchi, Takashi; Tsuchiya, Hiroyuki

    2015-01-01

    The first aim of this study was to evaluate combination antiemetic therapy consisting of 5-HT 3 receptor antagonists, neurokinin-1 receptor antagonists (NK-1RAs), and dexamethasone for multiple high emetogenic risk (HER) anticancer agents in bone and soft tissue sarcoma. The second aim was to compare the effectiveness of single-shot palonosetron and consecutive-day granisetron in a randomized, single-blinded crossover study. A single randomization method was used to assign eligible patients to the palonosetron or granisetron arm. Patients in the palonosetron arm received a palonosetron regimen during the first and third chemotherapy courses and a granisetron regimen during the second and fourth courses. All patients received NK-1RA and dexamethasone. Patients receiving the palonosetron regimen were administered 0.75 mg palonosetron on day 1, and patients receiving the granisetron regimen were administered 3 mg granisetron twice daily on days 1 through 5. All 24 patients in this study received at least 4 chemotherapy courses. A total of 96 courses of antiemetic therapy were evaluated. Overall, the complete response CR rate (no emetic episodes and no rescue medication use) was 34%, while the total control rate (a CR plus no nausea) was 7%. No significant differences were observed between single-shot palonosetron and consecutive-day granisetron. Antiemetic therapy with a 3-drug combination was not sufficient to control chemotherapy-induced nausea and vomiting (CINV) during chemotherapy with multiple HER agents for bone and soft tissue sarcoma. This study also demonstrated that consecutive-day granisetron was not inferior to single-shot palonosetron for treating CINV

  19. Efficacy of triplet regimen antiemetic therapy for chemotherapy-induced nausea and vomiting (CINV) in bone and soft tissue sarcoma patients receiving highly emetogenic chemotherapy, and an efficacy comparison of single-shot palonosetron and consecutive-day granisetron for CINV in a randomized, single-blinded crossover study.

    Science.gov (United States)

    Kimura, Hiroaki; Yamamoto, Norio; Shirai, Toshiharu; Nishida, Hideji; Hayashi, Katsuhiro; Tanzawa, Yoshikazu; Takeuchi, Akihiko; Igarashi, Kentaro; Inatani, Hiroyuki; Shimozaki, Shingo; Kato, Takashi; Aoki, Yu; Higuchi, Takashi; Tsuchiya, Hiroyuki

    2015-03-01

    The first aim of this study was to evaluate combination antiemetic therapy consisting of 5-HT3 receptor antagonists, neurokinin-1 receptor antagonists (NK-1RAs), and dexamethasone for multiple high emetogenic risk (HER) anticancer agents in bone and soft tissue sarcoma. The second aim was to compare the effectiveness of single-shot palonosetron and consecutive-day granisetron in a randomized, single-blinded crossover study. A single randomization method was used to assign eligible patients to the palonosetron or granisetron arm. Patients in the palonosetron arm received a palonosetron regimen during the first and third chemotherapy courses and a granisetron regimen during the second and fourth courses. All patients received NK-1RA and dexamethasone. Patients receiving the palonosetron regimen were administered 0.75 mg palonosetron on day 1, and patients receiving the granisetron regimen were administered 3 mg granisetron twice daily on days 1 through 5. All 24 patients in this study received at least 4 chemotherapy courses. A total of 96 courses of antiemetic therapy were evaluated. Overall, the complete response CR rate (no emetic episodes and no rescue medication use) was 34%, while the total control rate (a CR plus no nausea) was 7%. No significant differences were observed between single-shot palonosetron and consecutive-day granisetron. Antiemetic therapy with a 3-drug combination was not sufficient to control chemotherapy-induced nausea and vomiting (CINV) during chemotherapy with multiple HER agents for bone and soft tissue sarcoma. This study also demonstrated that consecutive-day granisetron was not inferior to single-shot palonosetron for treating CINV. © 2014 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

  20. Comparison between ultrasound guided technique and digital palpation technique for radial artery cannulation in adult patients: An updated meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Bhattacharjee, Sulagna; Maitra, Souvik; Baidya, Dalim K

    2018-03-22

    Possible advantages and risks associated with ultrasound guided radial artery cannulation in-comparison to digital palpation guided method in adult patients are not fully known. We have compared ultrasound guided radial artery cannulation with digital palpation technique in this meta-analysis. Meta-analysis of randomized controlled trials. Trials conducted in operating room, emergency department, cardiac catheterization laboratory. PubMed and Cochrane Central Register of Controlled Trials (CENTRAL) were searched (from 1946 to 20th November 2017) to identify prospective randomized controlled trials in adult patients. Two-dimensional ultrasound guided radial artery catheterization versus digital palpation guided radial artery cannulation. Overall cannulation success rate, first attempt success rate, time to cannulation and mean number of attempts to successful cannulation. Odds ratio (OR) and standardized mean difference (SMD) or mean difference (MD) with 95% confidence interval (CI) were calculated for categorical and continuous variables respectively. Data of 1895 patients from 10 studies have been included in this meta- analysis. Overall cannulation success rate was similar between ultrasound guided technique and digital palpation [OR (95% CI) 2.01 (1.00, 4.06); p = 0.05]. Ultrasound guided radial artery cannulation is associated with higher first attempt success rate of radial artery cannulation in comparison to digital palpation [OR (95% CI) 2.76 (186, 4.10); p guided technique with palpation technique. Radial artery cannulation by ultrasound guidance may increase the first attempt success rate but not the overall cannulation success when compared to digital palpation technique. However, results of this meta-analysis should be interpreted with caution due presence of heterogeneity. Copyright © 2018. Published by Elsevier Inc.

  1. Randomized Controlled Comparison of Two Cognitive Behavioral Therapies for Obese Children: Mother versus Mother-Child Cognitive Behavioral Therapy

    OpenAIRE

    Munsch, Simone; Roth, Binia; Michael, Tanja; Meyer, Andrea Hans; Biedert, Esther; Roth, Sandra; Speck, Vanessa; Zumsteg, Urs; Isler, Emanuel; Margraf, Jürgen

    2008-01-01

    BACKGROUND: Parent-child treatments have been shown to be superior to child-focused treatments of childhood obesity. Yet until now, the comparative effectiveness of parent-only and parent-child approaches has been little studied. METHOD: Fifty-six obese children and their families were randomly assigned to a 16-session cognitive behavioral therapy (CBT) for the parents only or for a combined treatment of parents and children. Children's percent overweight, the body mass index of their mothers...

  2. Simulated Microgravity Regulates Gene Transcript Profiles of 2T3 Preosteoblasts: Comparison of the Random Positioning Machine and the Rotating Wall Vessel Bioreactor

    Science.gov (United States)

    Patel, Mamta J.; Liu, Wenbin; Sykes, Michelle C.; Ward, Nancy E.; Risin, Semyon A.; Risin, Diana; Hanjoong, Jo

    2007-01-01

    Microgravity of spaceflight induces bone loss due in part to decreased bone formation by osteoblasts. We have previously examined the microgravity-induced changes in gene expression profiles in 2T3 preosteoblasts using the Random Positioning Machine (RPM) to simulate microgravity conditions. Here, we hypothesized that exposure of preosteoblasts to an independent microgravity simulator, the Rotating Wall Vessel (RWV), induces similar changes in differentiation and gene transcript profiles, resulting in a more confined list of gravi-sensitive genes that may play a role in bone formation. In comparison to static 1g controls, exposure of 2T3 cells to RWV for 3 days inhibited alkaline phosphatase activity, a marker of differentiation, and downregulated 61 genes and upregulated 45 genes by more than two-fold as shown by microarray analysis. The microarray results were confirmed with real time PCR for downregulated genes osteomodulin, bone morphogenic protein 4 (BMP4), runx2, and parathyroid hormone receptor 1. Western blot analysis validated the expression of three downregulated genes, BMP4, peroxiredoxin IV, and osteoglycin, and one upregulated gene peroxiredoxin I. Comparison of the microarrays from the RPM and the RWV studies identified 14 gravi-sensitive genes that changed in the same direction in both systems. Further comparison of our results to a published database showing gene transcript profiles of mechanically loaded mouse tibiae revealed 16 genes upregulated by the loading that were shown to be downregulated by RWV and RPM. These mechanosensitive genes identified by the comparative studies may provide novel insights into understanding the mechanisms regulating bone formation and potential targets of countermeasure against decreased bone formation both in astronauts and in general patients with musculoskeletal disorders.

  3. Blanket comparison and selection study. Volume II

    International Nuclear Information System (INIS)

    1983-10-01

    This volume contains extensive data for the following chapters: (1) solid breeder tritium recovery, (2) solid breeder blanket designs, (3) alternate blanket concept screening, and (4) safety analysis. The following appendices are also included: (1) blanket design guidelines, (2) power conversion systems, (3) helium-cooled, vanadium alloy structure blanket design, (4) high wall loading study, and (5) molten salt safety studies

  4. Cluster-randomized Studies in Educational Research: Principles and Methodological Aspects.

    Science.gov (United States)

    Dreyhaupt, Jens; Mayer, Benjamin; Keis, Oliver; Öchsner, Wolfgang; Muche, Rainer

    2017-01-01

    An increasing number of studies are being performed in educational research to evaluate new teaching methods and approaches. These studies could be performed more efficiently and deliver more convincing results if they more strictly applied and complied with recognized standards of scientific studies. Such an approach could substantially increase the quality in particular of prospective, two-arm (intervention) studies that aim to compare two different teaching methods. A key standard in such studies is randomization, which can minimize systematic bias in study findings; such bias may result if the two study arms are not structurally equivalent. If possible, educational research studies should also achieve this standard, although this is not yet generally the case. Some difficulties and concerns exist, particularly regarding organizational and methodological aspects. An important point to consider in educational research studies is that usually individuals cannot be randomized, because of the teaching situation, and instead whole groups have to be randomized (so-called "cluster randomization"). Compared with studies with individual randomization, studies with cluster randomization normally require (significantly) larger sample sizes and more complex methods for calculating sample size. Furthermore, cluster-randomized studies require more complex methods for statistical analysis. The consequence of the above is that a competent expert with respective special knowledge needs to be involved in all phases of cluster-randomized studies. Studies to evaluate new teaching methods need to make greater use of randomization in order to achieve scientifically convincing results. Therefore, in this article we describe the general principles of cluster randomization and how to implement these principles, and we also outline practical aspects of using cluster randomization in prospective, two-arm comparative educational research studies.

  5. Train High Eat Low for Osteoarthritis study (THE LO study: protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Yareni Guerrero

    2015-10-01

    Discussion: THE LO study will provide the first direct comparison of the long-term benefits of gait retraining, progressive resistance training and a high-protein/low-glycaemic-index energy-restricted diet, separately and in combination, on joint load, radiographic progression, symptoms, and associated co-morbidities in overweight/obese adults with OA of the knee.

  6. Comparison of oral paracetamol versus ibuprofen in premature infants with patent ductus arteriosus: a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Dan Dang

    Full Text Available TRIAL DESIGN: Oral ibuprofen has demonstrated good effects on symptomatic patent ductus arteriosus (PDA but with many contraindications and potential side-effects. In the past two years, oral paracetamol administration to several preterm infants with PDA has been reported. Here, a randomized, non-blinded, parallel-controlled and non-inferiority trial was designed to evaluate the efficacy and safety profiles of oral paracetamol to those of standard ibuprofen for PDA closure in premature infants. METHODS: One hundred and sixty infants (gestational age ≤ 34 weeks with echocardiographically confirmed PDA were randomly assigned to receive either oral paracetamol (n = 80 or ibuprofen (n = 80. After the initial treatment course in both groups, the need for a second course was determined by echocardiographic evaluation. The main outcome was rate of ductal closure, and secondary outcomes were adverse effects and complications. RESULT: The ductus was closed in 65 (81.2% infants of the paracetamol group compared with 63 (78.8% of the ibuprofen group. The 95% confidence interval of the difference between these groups was [-0.080,0.128], demonstrating that the effectiveness of paracetamol treatment was not inferior to that of ibuprofen. In fact, the incidence of hyperbilirubinemia or gastrointestinal bleeding in the paracetamol group was significantly lower than that of the ibuprofen group. No significant differences in other clinical side effects or complications were noted. CONCLUSION: This comparison of drug efficacy and safety profiles in premature infants with PDA revealed that oral paracetamol was comparable to ibuprofen in terms of the rate of ductal closure and even showed a decreased risk of hyperbilirubinemia or gastrointestinal bleeding. Therefore, paracetamol may be accepted as a first-line drug treatment for PDA in preterm infants. TRIAL REGISTRATION: ChiCTR.org ChiCTR-TRC-12002177.

  7. Cooperative Research Twin Trawl Sweep Comparison Study

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The "Twin-Trawl Sweep Efficiency Study" was intended to compare the sweep efficiency and selectivity of the NEFSC standardized bottom trawl to that of a standardized...

  8. Elevated serum urate is a potential factor in reduction of total bilirubin: a Mendelian randomization study

    Science.gov (United States)

    Zhang, Hui; Liu, Jing; Dong, Zheng; Ding, Yue; Qian, Qiaoxia; Zhou, Jingru; Ma, Yanyun; Mei, Zhendong; Chen, Xiangxiang; Li, Yuan; Yuan, Ziyu; Zhang, Juan; Yang, Yajun; Chen, Xingdong; Jin, Li; Zou, Hejian; Wang, Xiaofeng; Wang, Jiucun

    2017-01-01

    Aim A Mendelian randomization study (MRS) can be linked to a “natural” randomized controlled trial in order to avoid potential bias of observational epidemiology. We aimed to study the possible association between serum urate (SU) and total bilirubin (TBIL) using MRS. Materials and Methods An observational epidemiological study using ordinary least squares (OLS) regression and MRS using two-stage least square (TLS) regression was conducted to assess the effect of SU on TBIL. The comparison between the OLS regression and the TLS regression was analyzed by the Durbin-Hausman test. If the p value is significant, it suggests that the OLS regression cannot evaluate the relationship between exposure and outcome, and the TLS regression is precise; while if the p value is not significant, there would be no significant difference between the two regressions. Results A total of 3,753 subjects were analyzed. In OLS regression, there was no significant association between SU and TBIL in all subjects and subgroup analysis (all p > 0.05). However, MRS revealed a negative correlation between SU and TBIL after adjustment for confounders (beta = –0.021, p = 0.010). Further analysis was conducted in different SU subgroups, and results show that elevated SU was associated with a significant reduction in TBIL after adjustment for hyperuricemic subjects (beta = –0.053, p = 0.027). In addition, the results using the Durbin-Hausman test further confirmed a negative effect of SU on TBIL (p = 0.002 and 0.010, respectively). Conclusions This research shows for the first time that elevated SU was a potential causal factor in the reduction of TBIL and it provides strong evidence to resolve the controversial association between SU and TBIL. PMID:29262606

  9. A randomized clinical study of two interceptive approaches to palatally displaced canines.

    Science.gov (United States)

    Baccetti, Tiziano; Leonardi, Maria; Armi, Pamela

    2008-08-01

    This study evaluated the effectiveness of two interceptive approaches to palatally displaced canines (PDC), i.e. extraction of the primary canines alone or in association with the use of a cervical-pull headgear. The randomized prospective design comprised 75 subjects with PDC (92 maxillary canines) who were randomly assigned to three groups: extraction of the primary canine only (EG), extraction of the primary canine and cervical-pull headgear (EHG), and an untreated control group (CG). Panoramic radiographs were evaluated at the time of initial observation (T1) and after an average period of 18 months (T2). At T2, an evaluation of the success of canine eruption was undertaken. Between-group statistical comparisons, Kruskal-Wallis test with Bonferroni correction, were performed on the T1-T2 changes of the diagnostic parameters on panoramic radiographs and the prevalence rates of success in canine eruption. A superimposition study on lateral cephalograms at T1 and T2 was carried out to evaluate the changes in the sagittal position of the upper molars in the three groups. The removal of the primary canine as an isolated measure to intercept palatal displacement of maxillary canines showed a success rate of 65.2 per cent, which was significantly greater than that in the untreated controls (36 per cent). The additional use of a headgear resulted in successful eruption in 87.5 per cent of the subjects, with a significant improvement in the measurements for intraosseous canine position. The cephalometric superimposition study showed a significant mesial movement of the upper first molars in the CG and EG when compared with the EHG.

  10. Prolonged sitting and markers of cardiometabolic disease risk in children and youth: a randomized crossover study.

    Science.gov (United States)

    Saunders, Travis J; Chaput, Jean-Philippe; Goldfield, Gary S; Colley, Rachel C; Kenny, Glen P; Doucet, Eric; Tremblay, Mark S

    2013-10-01

    Recent evidence suggests that short bouts of uninterrupted sedentary behavior reduce insulin sensitivity and glucose tolerance while increasing triglyceride levels in both healthy and overweight/obese adults. To date no study has examined the acute impact of uninterrupted sitting in children and youth. The objective of the present study was to determine whether 8 h of uninterrupted sitting increases markers of cardiometabolic disease risk in healthy children and youth, in comparison to 8 h of sitting interrupted by light intensity walk breaks or structured physical activity. 11 healthy males and 8 healthy females between the ages of 10 and 14 years experienced 3 conditions in random order: (1) 8 h of uninterrupted sitting (Sedentary); (2) 8 h of sitting interrupted with a 2-min light-intensity walk break every 20 min (Breaks); and (3) 8 h of sitting interrupted with a 2-min light-intensity walk break every 20 min as well as 2×20 min of moderate-intensity physical activity (Breaks+Physical Activity). Insulin, glucose, triglyceride, HDL and LDL cholesterol area under the curve were calculated for each condition. We observed no significant differences in the area under the curve for any marker of cardiometabolic disease risk across the 3 study conditions (all p>0.09). These results suggest that in comparison to interrupted sitting or structured physical activity, a single bout of 8 h of uninterrupted sitting does not result in measurable changes in circulating levels of insulin, glucose, or lipids in healthy children and youth. Copyright © 2013 Elsevier Inc. All rights reserved.

  11. Comparison of confirmed inactive and randomly selected compounds as negative training examples in support vector machine-based virtual screening.

    Science.gov (United States)

    Heikamp, Kathrin; Bajorath, Jürgen

    2013-07-22

    The choice of negative training data for machine learning is a little explored issue in chemoinformatics. In this study, the influence of alternative sets of negative training data and different background databases on support vector machine (SVM) modeling and virtual screening has been investigated. Target-directed SVM models have been derived on the basis of differently composed training sets containing confirmed inactive molecules or randomly selected database compounds as negative training instances. These models were then applied to search background databases consisting of biological screening data or randomly assembled compounds for available hits. Negative training data were found to systematically influence compound recall in virtual screening. In addition, different background databases had a strong influence on the search results. Our findings also indicated that typical benchmark settings lead to an overestimation of SVM-based virtual screening performance compared to search conditions that are more relevant for practical applications.

  12. A Randomized Comparison of In-hospital Rescuer Positions for Endotracheal Intubation in a Difficult Airway

    OpenAIRE

    Le Parc, Joanna M.; Bischof, Jason J.; King, Andrew M.; Greenberger, Sarah; Way, David P.; Panchal, Ashish R.; Finnegan, Geoffrey I.; Terndrup, Thomas E.

    2018-01-01

    Introduction: Emergency endotracheal intubation (ETI) is a common and critical procedure performed in both prehospital and in-hospital settings. Studies of prehospital providers have demonstrated that rescuer position influences ETI outcomes. However, studies of in-hospital rescuer position for ETI are limited. While we adhere to strict standards for the administration of ETI, we posited that perhaps requiring in-hospital rescuers to stand for ETI is an obstacle to effectiveness. Our objectiv...

  13. Comparison of preservative-free latanoprost and preservative-free bimatoprost in a multicenter, randomized, investigator-masked cross-over clinical trial, the SPORT trial.

    Science.gov (United States)

    Stalmans, Ingeborg; Oddone, Francesco; Cordeiro, Maria Francesca; Hommer, Anton; Montesano, Giovanni; Ribeiro, Luisa; Sunaric-Mégevand, Gordana; Rossetti, Luca

    2016-06-01

    The aim of this study was to investigate the efficacy and safety of Bimatoprost Unit Dose Preservative Free (BUDPF) and Latanoprost Unit Dose Preservative Free (LUDPF). A prospective, randomized, investigator-masked, cross-over comparison was used. Inclusion criteria were ocular hypertension (OHT) or open-angle glaucoma (OAG) with a maximum intraocular pressure (IOP) of 21 mmHg on a preserved prostaglandin monotherapy. After 6 weeks washout, patients were randomized to BUDPF or LUDPF for 3 months and then switched to the other treatment for 3 months. IOP curves were performed at baseline and after each treatment period. Statistical analysis was performed in a R programming environment. Linear mixed modeling was used to account for repeated measures on the same subject and clustering of observations from the same center. Safety outcomes included visual acuity, adverse events, slit-lamp biomicroscopy, ocular tolerability, and optic nerve assessment. Analysis at 6 months (primary outcome) showed a 1.6 ± 0.5-mmHg difference in IOP values between LUDPF and BUDPF (p < 0.01). A mean intra-subject IOP difference of 0.9 ± 0.2 mmHg (LUDPF - BUDPF) was observed (p < 0.01).. Significant differences in IOP were observed for both drugs at 3 and at 6 months compared to baseline: -4,0 ± 0.5 mmHg for both BUDPF and LUDPF at 3 months (p < 0.01 for both drugs; p = 0.32 between the two drugs); -5.2 ± 0.5 and -3.4 ± 0.5 mmHg for BUDPF and LUDPF, respectively (both p < 0.01), at 6 months. Both drugs were tolerated well, the only statistically significant difference being lower hyperemia scores for LUDPF (albeit low for both drugs). This study demonstrates a superior efficacy of BUDPF over LUDPF in lowering IOP. The results are consistent both in the parallel comparison between the two treatment groups at 6 months as well as in the intra-subject pressure comparison.

  14. Characterisation and comparison of case study findings

    DEFF Research Database (Denmark)

    Jørgensen, Michael Søgaard; Dorland, Jens; Pel, Bonno

    2015-01-01

    This report gives an overview and a comparative analysis of the findings from the 12 first case study reports in TRANSIT about aspects of transformative social innovation (TSI). Each of the 12 reports, on which the report is based, includes an analysis of a transnational social innovation network...

  15. Quantification of uncertainties in turbulence modeling: A comparison of physics-based and random matrix theoretic approaches

    International Nuclear Information System (INIS)

    Wang, Jian-Xun; Sun, Rui; Xiao, Heng

    2016-01-01

    Highlights: • Compared physics-based and random matrix methods to quantify RANS model uncertainty. • Demonstrated applications of both methods in channel ow over periodic hills. • Examined the amount of information introduced in the physics-based approach. • Discussed implications to modeling turbulence in both near-wall and separated regions. - Abstract: Numerical models based on Reynolds-Averaged Navier-Stokes (RANS) equations are widely used in engineering turbulence modeling. However, the RANS predictions have large model-form uncertainties for many complex flows, e.g., those with non-parallel shear layers or strong mean flow curvature. Quantification of these large uncertainties originating from the modeled Reynolds stresses has attracted attention in the turbulence modeling community. Recently, a physics-based Bayesian framework for quantifying model-form uncertainties has been proposed with successful applications to several flows. Nonetheless, how to specify proper priors without introducing unwarranted, artificial information remains challenging to the current form of the physics-based approach. Another recently proposed method based on random matrix theory provides the prior distributions with maximum entropy, which is an alternative for model-form uncertainty quantification in RANS simulations. This method has better mathematical rigorousness and provides the most non-committal prior distributions without introducing artificial constraints. On the other hand, the physics-based approach has the advantages of being more flexible to incorporate available physical insights. In this work, we compare and discuss the advantages and disadvantages of the two approaches on model-form uncertainty quantification. In addition, we utilize the random matrix theoretic approach to assess and possibly improve the specification of priors used in the physics-based approach. The comparison is conducted through a test case using a canonical flow, the flow past

  16. Conducting Indirect-Treatment-Comparison and Network-Meta-Analysis Studies : Report of the ISPOR Task Force on Indirect Treatment Comparisons Good Research Practices: Part 2

    NARCIS (Netherlands)

    Hoaglin, David C.; Hawkins, Neil; Jansen, Jeroen P.; Scott, David A.; Itzler, Robbin; Cappelleri, Joseph C.; Boersma, Cornelis; Thompson, David; Larholt, Kay M.; Diaz, Mireya; Barrett, Annabel

    Evidence-based health care decision making requires comparison of all relevant competing interventions. In the absence of randomized controlled trials involving a direct comparison of all treatments of interest, indirect treatment comparisons and network meta-analysis provide useful evidence for

  17. Partial-thickness burn wounds healing by topical treatment: A randomized controlled comparison between silver sulfadiazine and centiderm.

    Science.gov (United States)

    Saeidinia, Amin; Keihanian, Faeze; Lashkari, Ardalan Pasdaran; Lahiji, Hossein Ghavvami; Mobayyen, Mohammadreza; Heidarzade, Abtin; Golchai, Javad

    2017-03-01

    Burns are common event and associated with a high incidence of death, disability, and high costs. Centella asiatica (L.) is a medicinal herb, commonly growing in humid areas in several tropical countries that improve wound healing. On the basis of previous studies, we compared the efficacy of Centiderm versus silver sulfadiazine (SSD) in partial thickness burning patients. Study population comprised burn victims referred to Velayat Burning Hospital at Rasht, Iran. The intervention group received Centiderm and control group SSD cream. Burn wounds were treated once daily at home. All of the wounds were evaluated till complete healing occurred and at the admission, days 3, 7, 14 objective signs; visual acuity score (VAS) and subjective signs were recorded. Re-epithelialization time and complete healing days were recorded. We used random fixed block for randomization. The randomization sequence was created using the computer. Patients and burning specialist physician were blinded. Seventy-five patients randomized into 2 groups; (40 patients: Centiderm group; 35 patients: SSD group). The mean age of them was 30.67 ± 9.91 years and 19 of them were male (31.7%). Thirty patients in Centiderm and 30 patients in SSD group were analyzed. All of objective and subjective signs and mean of re-epithelialization and complete healing were significantly better in Centiderm group rather than SSD group (P < 0.05). There was no infection in Centiderm group. We showed that use of Centiderm ointment not only improved the objective and subjective signs in less than 3 days, but also the re-epithelialization and complete healing rather than SSD without any infection in the subjects.

  18. A simulation study on estimating biomarker-treatment interaction effects in randomized trials with prognostic variables.

    Science.gov (United States)

    Haller, Bernhard; Ulm, Kurt

    2018-02-20

    To individualize treatment decisions based on patient characteristics, identification of an interaction between a biomarker and treatment is necessary. Often such potential interactions are analysed using data from randomized clinical trials intended for comparison of two treatments. Tests of interactions are often lacking statistical power and we investigated if and how a consideration of further prognostic variables can improve power and decrease the bias of estimated biomarker-treatment interactions in randomized clinical trials with time-to-event outcomes. A simulation study was performed to assess how prognostic factors affect the estimate of the biomarker-treatment interaction for a time-to-event outcome, when different approaches, like ignoring other prognostic factors, including all available covariates or using variable selection strategies, are applied. Different scenarios regarding the proportion of censored observations, the correlation structure between the covariate of interest and further potential prognostic variables, and the strength of the interaction were considered. The simulation study revealed that in a regression model for estimating a biomarker-treatment interaction, the probability of detecting a biomarker-treatment interaction can be increased by including prognostic variables that are associated with the outcome, and that the interaction estimate is biased when relevant prognostic variables are not considered. However, the probability of a false-positive finding increases if too many potential predictors are included or if variable selection is performed inadequately. We recommend undertaking an adequate literature search before data analysis to derive information about potential prognostic variables and to gain power for detecting true interaction effects and pre-specifying analyses to avoid selective reporting and increased false-positive rates.

  19. Effects of 5 Weeks of Bench Press Training on Muscle Synergies: A Randomized Controlled Study.

    Science.gov (United States)

    Kristiansen, Mathias; Samani, Afshin; Madeleine, Pascal; Hansen, Ernst A

    2016-07-01

    Kristiansen, M, Samani, A, Madeleine, P, and Hansen, EA. Effects of 5 weeks of bench press training on muscle synergies: A randomized controlled study. J Strength Cond Res 30(7): 1948-1959, 2016-The ability to perform forceful muscle contractions has important implications in sports performance and in activities of daily living. However, there is a lack of knowledge on adaptations in intermuscular coordination after strength training. The purpose of this study was therefore to assess muscle synergies before and after 5 weeks of bench press training. Thirty untrained male subjects were randomly allocated to a training group (TRA) or a control group (CON). After the pretest, TRA completed 5 weeks of bench press training, before completing a posttest, whereas subjects in CON continued their normal life. During test sessions, surface electromyography (EMG) was recorded from 13 different muscles. Muscle synergies were extracted from EMG data using nonnegative matrix factorization. To evaluate differences between pretest and posttest, we performed a cross-correlation analysis and a cross-validation analysis, in which the synergy components extracted in the pretest session were recomputed, using the fixed synergy components from the posttest session. Two muscle synergies accounted for 90% of the total variance and reflected the concentric and eccentric phase, respectively. TRA significantly increased 3 repetition maximum in bench press with 19.0% (25th; 75th percentile, 10.3%; 21.7%) (p < 0.001), whereas no change occurred in CON. No significant differences were observed in synergy components between groups. However, decreases in correlation values for intragroup comparisons in TRA may suggest that the synergy components changed, whereas this was not the case in CON. Strength and conditioning professionals may consider monitoring changes in muscle synergies in training and rehabilitation programs as a way to benchmark changes in intermuscular coordination.

  20. Management of Pleural Space After Lung Resection by Cryoneuroablation of Phrenic Nerve: A Randomized Study.

    Science.gov (United States)

    Pan, Xiao-Jie; Ou, De-Bin; Lin, Xing; Ye, Ming-Fang

    2017-06-01

    Residual air space problems after pulmonary lobectomy are an important concern in thoracic surgical practice, and various procedures have been applied to manage them. This study describes a novel technique using controllable paralysis of the diaphragm by localized freezing of the phrenic nerve, and assesses the effectiveness of this procedure to reduce air space after pulmonary lobectomy. In this prospective randomized study, 207 patients who underwent lobectomy or bilobectomy and systematic mediastinal node dissection in our department between January 2009 and November 2013 were randomly allocated to a cryoneuroablation group or a conventional group. Patients in the cryoneuroablation group (n = 104) received phrenic nerve cryoneuroablation after lung procedures, and patients in the conventional group (n = 103) did not receive cryoneuroablation after the procedure. Data regarding preoperative clinical and surgical characteristics in both groups were collected. Both groups were compared with regard to postoperative parameters such as total amount of pleural drainage, duration of chest tube placement, length of hospital stay, requirement for repeat chest drain insertion, prolonged air leak, and residual space. Perioperative lung function was also compared in both groups. Recovery of diaphragmatic movement in the cryoneuroablation group was checked by fluoroscopy on the 15th, 30th, and 60th day after surgery. There was no statistically significant difference in patient characteristics between the 2 groups; nor was there a difference in terms of hospital stay, new drain requirement, and incidence of empyema. In comparison with the conventional group, the cryoneuroablation group had less total drainage (1024 ± 562 vs 1520 ± 631 mL, P phrenic nerve offers a reasonable option for prevention of residual air space following major pulmonary resection.

  1. The Maudsley Outpatient Study of Treatments for Anorexia Nervosa and Related Conditions (MOSAIC): Comparison of the Maudsley Model of Anorexia Nervosa Treatment for Adults (MANTRA) with specialist supportive clinical management (SSCM) in outpatients with broadly defined anorexia nervosa: A randomized controlled trial.

    Science.gov (United States)

    Schmidt, Ulrike; Magill, Nicholas; Renwick, Bethany; Keyes, Alexandra; Kenyon, Martha; Dejong, Hannah; Lose, Anna; Broadbent, Hannah; Loomes, Rachel; Yasin, Huma; Watson, Charlotte; Ghelani, Shreena; Bonin, Eva-Maria; Serpell, Lucy; Richards, Lorna; Johnson-Sabine, Eric; Boughton, Nicky; Whitehead, Linette; Beecham, Jennifer; Treasure, Janet; Landau, Sabine

    2015-08-01

    Anorexia nervosa (AN) in adults has poor outcomes, and treatment evidence is limited. This study evaluated the efficacy and acceptability of a novel, targeted psychological therapy for AN (Maudsley Model of Anorexia Nervosa Treatment for Adults; MANTRA) compared with Specialist Supportive Clinical Management (SSCM). One hundred forty-two outpatients with broadly defined AN (body mass index [BMI] ≤ 18.5 kg/m²) were randomly allocated to receive 20 to 30 weekly sessions (depending on clinical severity) plus add-ons (4 follow-up sessions, optional sessions with dietician and with carers) of MANTRA (n = 72) or SSCM (n = 70). Assessments were administered blind to treatment condition at baseline, 6 months, and 12 months after randomization. The primary outcome was BMI at 12 months. Secondary outcomes included eating disorders symptomatology, other psychopathology, neuro-cognitive and social cognition, and acceptability. Additional service utilization was also assessed. Outcomes were analyzed using linear mixed models. Both treatments resulted in significant improvements in BMI and reductions in eating disorders symptomatology, distress levels, and clinical impairment over time, with no statistically significant difference between groups at either 6 or 12 months. Improvements in neuro-cognitive and social-cognitive measures over time were less consistent. One SSCM patient died. Compared with SSCM, MANTRA patients rated their treatment as significantly more acceptable and credible at 12 months. There was no significant difference between groups in additional service consumption. Both treatments appear to have value as first-line outpatient interventions for patients with broadly defined AN. Longer term outcomes remain to be evaluated. (c) 2015 APA, all rights reserved).

  2. Comparison of the pharmacokinetics of a new 30 mg modified-release tablet formulation of metoclopramide for once-a-day administration versus 10 mg immediate-release tablets: a single and multiple-dose, randomized, open-label, parallel study in healthy male subjects.

    Science.gov (United States)

    Bernardo-Escudero, Roberto; Alonso-Campero, Rosalba; Francisco-Doce, María Teresa de Jesús; Cortés-Fuentes, Myriam; Villa-Vargas, Miriam; Angeles-Uribe, Juan

    2012-12-01

    The study aimed to assess the pharmacokinetics of a new, modified-release metoclopramide tablet, and compare it to an immediate-release tablet. A single and multiple-dose, randomized, open-label, parallel, pharmacokinetic study was conducted. Investigational products were administered to 26 healthy Hispanic Mexican male volunteers for two consecutive days: either one 30 mg modified-release tablet every 24 h, or one 10 mg immediate-release tablet every 8 h. Blood samples were collected after the first and last doses of metoclopramide. Plasma metoclopramide concentrations were determined by high-performance liquid chromatography. Safety and tolerability were assessed through vital signs measurements, clinical evaluations, and spontaneous reports from study subjects. All 26 subjects were included in the analyses [mean (SD) age: 27 (8) years, range 18-50; BMI: 23.65 (2.22) kg/m², range 18.01-27.47)]. Peak plasmatic concentrations were not statistically different with both formulations, but occurred significantly later (p 0.05)]. One adverse event was reported in the test group (diarrhea), and one in the reference group (headache). This study suggests that the 30 mg modified-release metoclopramide tablets show features compatible with slow-release formulations when compared to immediate-release tablets, and is suitable for once-a-day administration.

  3. Sucralfate gel as a radioprotector against radiation induced dermatitis in a hypo-fractionated schedule: a non-randomized study.

    Science.gov (United States)

    Kouloulias, V; Asimakopoulos, C; Tolia, M; Filippou, G; Platoni, K; Dilvoi, M; Beli, I; Georgakopoulos, J; Patatoukas, G; Kelekis, N

    2013-04-01

    External beam radiotherapy with high doses provokes many acute skin reactions, such as erythema and moist desquamation. Many topical preparations are used in radiation oncology departments in the skin care. Sucralfate humid gel, a colloidal physical form of the anti-ulcer drug sucralfate, promotes epithelial regeneration and activates cell proliferation. Based on this knowledge, we performed a non-randomized clinical trial to evaluate the efficacy of topical sucralfate gel in 30 breast cancer patients receiving postoperative accelerated hypofractionated photon beam therapy. The comparison was performed with 30 patients as historical controls. The acute reaction of the skin was significantly lower in the group receiving the sucralfate gel (p<0.05, Mann Whitney test), while 90% of the patients had no evidence of radiation induced skin toxicity. There was no sucralfate gel related toxicity reported by any patient in this study. More patients in a randomized way are needed for more definite results.

  4. Vegetable versus animal protein diet in cirrhotic patients with chronic encephalopathy. A randomized cross-over comparison.

    Science.gov (United States)

    Bianchi, G P; Marchesini, G; Fabbri, A; Rondelli, A; Bugianesi, E; Zoli, M; Pisi, E

    1993-05-01

    In a randomized cross-over comparison, the effects of a mainly vegetable protein diet were compared with an animal protein diet in eight patients with cirrhosis and chronic permanent encephalopathy, under optimum lactulose therapy. After a run-in period, patients were fed two equi-caloric, equi-nitrogenous diets for 7 days (71 g total proteins), containing either 50 g protein of animal origin or 50 g vegetable proteins. In the last 3 days of each period, nitrogen balance was significantly better during the vegetable protein diet (+0.2 (SD 1.4) g vs. -1.7 (2.4); P vegetable proteins, whereas insulin, plasma amino acids and ammonia were lower. The clinical grading of encephalopathy improved slightly on vegetable proteins, and psychometric tests improved significantly, but remained grossly abnormal. Compliance to dietary manipulation was good. The data prove that a mainly vegetable protein diet is worthwhile in cirrhotic patients with chronic encephalopathy under optimum lactulose therapy. Improved nitrogen balance may be related to more effective nitrogen use for protein synthesis, probably due to blunted hormonal response, and largely outweighs the effects on encephalopathy.

  5. Cluster-randomized Studies in Educational Research: Principles and Methodological Aspects

    Directory of Open Access Journals (Sweden)

    Dreyhaupt, Jens

    2017-05-01

    Full Text Available An increasing number of studies are being performed in educational research to evaluate new teaching methods and approaches. These studies could be performed more efficiently and deliver more convincing results if they more strictly applied and complied with recognized standards of scientific studies. Such an approach could substantially increase the quality in particular of prospective, two-arm (intervention studies that aim to compare two different teaching methods. A key standard in such studies is randomization, which can minimize systematic bias in study findings; such bias may result if the two study arms are not structurally equivalent. If possible, educational research studies should also achieve this standard, although this is not yet generally the case. Some difficulties and concerns exist, particularly regarding organizational and methodological aspects. An important point to consider in educational research studies is that usually individuals cannot be randomized, because of the teaching situation, and instead whole groups have to be randomized (so-called “cluster randomization”. Compared with studies with individual randomization, studies with cluster randomization normally require (significantly larger sample sizes and more complex methods for calculating sample size. Furthermore, cluster-randomized studies require more complex methods for statistical analysis. The consequence of the above is that a competent expert with respective special knowledge needs to be involved in all phases of cluster-randomized studies.Studies to evaluate new teaching methods need to make greater use of randomization in order to achieve scientifically convincing results. Therefore, in this article we describe the general principles of cluster randomization and how to implement these principles, and we also outline practical aspects of using cluster randomization in prospective, two-arm comparative educational research studies.

  6. Comparison Between Two Methods for Estimating the Vertical Scale of Fluctuation for Modeling Random Geotechnical Problems

    Science.gov (United States)

    Pieczyńska-Kozłowska, Joanna M.

    2015-12-01

    The design process in geotechnical engineering requires the most accurate mapping of soil. The difficulty lies in the spatial variability of soil parameters, which has been a site of investigation of many researches for many years. This study analyses the soil-modeling problem by suggesting two effective methods of acquiring information for modeling that consists of variability from cone penetration test (CPT). The first method has been used in geotechnical engineering, but the second one has not been associated with geotechnics so far. Both methods are applied to a case study in which the parameters of changes are estimated. The knowledge of the variability of parameters allows in a long term more effective estimation, for example, bearing capacity probability of failure.

  7. Benefits of preparing for childbirth with mindfulness training: a randomized controlled trial with active comparison

    OpenAIRE

    Duncan, Larissa G.; Cohn, Michael A.; Chao, Maria T.; Cook, Joseph G.; Riccobono, Jane; Bardacke, Nancy

    2017-01-01

    Background Childbirth fear is linked with lower labor pain tolerance and worse postpartum adjustment. Empirically validated childbirth preparation options are lacking for pregnant women facing this problem. Mindfulness approaches, now widely disseminated, can alleviate symptoms of both chronic and acute pain and improve psychological adjustment, suggesting potential benefit when applied to childbirth education. Methods This study?, the Prenatal Education About Reducing Labor Stress (PEARLS) s...

  8. Cost efficiency of Japanese steam power generation companies: A Bayesian comparison of random and fixed frontier models

    Energy Technology Data Exchange (ETDEWEB)

    Assaf, A. George [Isenberg School of Management, University of Massachusetts-Amherst, 90 Campus Center Way, Amherst 01002 (United States); Barros, Carlos Pestana [Instituto Superior de Economia e Gestao, Technical University of Lisbon, Rua Miguel Lupi, 20, 1249-078 Lisbon (Portugal); Managi, Shunsuke [Graduate School of Environmental Studies, Tohoku University, 6-6-20 Aramaki-Aza Aoba, Aoba-Ku, Sendai 980-8579 (Japan)

    2011-04-15

    This study analyses and compares the cost efficiency of Japanese steam power generation companies using the fixed and random Bayesian frontier models. We show that it is essential to account for heterogeneity in modelling the performance of energy companies. Results from the model estimation also indicate that restricting CO{sub 2} emissions can lead to a decrease in total cost. The study finally discusses the efficiency variations between the energy companies under analysis, and elaborates on the managerial and policy implications of the results. (author)

  9. Comparison of tool feed influence in CNC polishing between a novel circular-random path and other pseudo-random paths.

    Science.gov (United States)

    Takizawa, Ken; Beaucamp, Anthony

    2017-09-18

    A new category of circular pseudo-random paths is proposed in order to suppress repetitive patterns and improve surface waviness on ultra-precision polished surfaces. Random paths in prior research had many corners, therefore deceleration of the polishing tool affected the surface waviness. The new random path can suppress velocity changes of the polishing tool and thus restrict degradation of the surface waviness, making it suitable for applications with stringent mid-spatial-frequency requirements such as photomask blanks for EUV lithography.

  10. Comparison of Synchronization Indices: Behavioral Study

    Directory of Open Access Journals (Sweden)

    Pierre Dugué

    2009-01-01

    Full Text Available The synchronization of a neuronal response to a given periodic stimulus is usually measured by Goldberg and Brown's vector strength metric. This index does not take omitted spikes into account. This particular limitation has motivated the development of two new indices: the corrected vector strength index and the corrected phase variance index, both including a penalty factor linked to the firing rate. In this paper, a theoretical study on the normalization of the corrected phase variance index is conducted. Both indices are compared to four existing ones using a simulated dataset which considers three desynchronizing disturbances: irregularity in firing, added spikes, and omitted spikes. In the case of unimodal responses, the two new indices are satisfying and appear the more promising in the case of real signals. In the multimodal case, the entropy-based index is better than the others even if this index is not drawback-free.

  11. Comparison of the Effects of Attachment Training for Mothers on the Behavioral Responses of Premature Infants: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Mitra Edraki

    2015-06-01

    Full Text Available Background: Premature infants are among high-risk groups in community who need to be hospitalized at intensive care units for survival and receiving basic or special care. Hospitalization at neonatal intensive care units (NICUs unsettles the family and leads to the separation of parents from their infants. This study aimed to determine the effects of maternal attachment behaviors on the behavioral responses of premature infants, hospitalized at NICUs. Methods: In this randomized clinical trial, 64 premature infants, who were hospitalized at NICUs and were eligible for the study, were randomly allocated to study and control groups. Attachment behaviors including touching, massage and kangaroo care were applied for the study group, while the conventional attachment method was adopted for the control group. Behavioral responses were evaluated two hours before and two hours after training attachment behaviors. Data were analyzed, using Chi-square and student’s t-test. Results: The mean difference in the duration of deep sleep and consciousness was more significant in the study group, compared to the control group. Furthermore, the duration of drowsiness was significantly less in the study group, compared to the control group. Conclusion: The implementation of attachment training at NICUs decreased the time of drowsiness and improved behavioral responses, deep sleep time and consciousness.

  12. A Study on the Amount of Random Graph Groupies

    OpenAIRE

    Lu, Daodi

    2013-01-01

    In 1980, Ajtai, Komlos and Szemer{\\'e}di defined "groupie": Let $G=(V,E)$ be a simple graph, $|V|=n$, $|E|=e$. For a vertex $v\\in V$, let $r(v)$ denote the sum of the degrees of the vertices adjacent to $v$. We say $v\\in V$ is a {\\it groupie}, if $\\frac{r(v)}{\\deg(v)}\\geq\\frac{e}{n}.$ In this paper, we prove that in random graph $B(n,p)$, $0

  13. Simulation and study of small numbers of random events

    Science.gov (United States)

    Shelton, R. D.

    1986-01-01

    Random events were simulated by computer and subjected to various statistical methods to extract important parameters. Various forms of curve fitting were explored, such as least squares, least distance from a line, maximum likelihood. Problems considered were dead time, exponential decay, and spectrum extraction from cosmic ray data using binned data and data from individual events. Computer programs, mostly of an iterative nature, were developed to do these simulations and extractions and are partially listed as appendices. The mathematical basis for the compuer programs is given.

  14. Inverse probability weighting for covariate adjustment in randomized studies.

    Science.gov (United States)

    Shen, Changyu; Li, Xiaochun; Li, Lingling

    2014-02-20

    Covariate adjustment in randomized clinical trials has the potential benefit of precision gain. It also has the potential pitfall of reduced objectivity as it opens the possibility of selecting a 'favorable' model that yields strong treatment benefit estimate. Although there is a large volume of statistical literature targeting on the first aspect, realistic solutions to enforce objective inference and improve precision are rare. As a typical randomized trial needs to accommodate many implementation issues beyond statistical considerations, maintaining the objectivity is at least as important as precision gain if not more, particularly from the perspective of the regulatory agencies. In this article, we propose a two-stage estimation procedure based on inverse probability weighting to achieve better precision without compromising objectivity. The procedure is designed in a way such that the covariate adjustment is performed before seeing the outcome, effectively reducing the possibility of selecting a 'favorable' model that yields a strong intervention effect. Both theoretical and numerical properties of the estimation procedure are presented. Application of the proposed method to a real data example is presented. Copyright © 2013 John Wiley & Sons, Ltd.

  15. Comparison of 4 supraglotttic devices used by paramedics during simulated CPR : a randomized controlled crossover trial.

    Science.gov (United States)

    Szarpak, Łukasz; Kurowski, Andrzej; Truszewski, Zenon; Robak, Oliver; Frass, Michael

    2015-08-01

    Ensuring an open airway during cardiopulmonary resuscitation is fundamental. The aim of this study was to determine the success rate of blind intubation during simulated cardiopulmonary resuscitation by untrained personnel. Four devices were compared in a simulated resuscitation scenario: ILMA (Intavent Direct Ltd, Buckinghamshire, United Kingdom), Cobra PLA (Engineered Medical Systems Inc, Indianapolis, IN), Supraglottic Airway Laryngopharyngeal Tube (SALT) (ECOLAB, St. Paul, MN), and Air-Q (Mercury Medical, Clearwater, FL). A group of 210 paramedics intubated a manikin with continuous chest compressions. The mean times to intubation were 40.46 ± 4.64, 33.96 ± 6.23, 17.2 ± 4.63, and 49.23 ± 13.19 seconds (SALT vs ILMA, Cobra PLA, and Air-Q; P blind intubation for the devices were 86.7%, 85.7%, 100%, and 71.4% (SALT vs ILMA, Cobra PLA, and Air-Q; P blind intubation time was the SALT device. Copyright © 2015 Elsevier Inc. All rights reserved.

  16. Ella-V and technology usage technology usage in an english language and literacy acquisition validation randomized controlled trial study

    Directory of Open Access Journals (Sweden)

    Roisin P. Corcoran

    2014-12-01

    Full Text Available This paper describes the use of technology to provide virtual professional development (VPD for teachers and to conduct classroom observations in a study of English Language Learner (ELL instruction in grades K–3. The technology applications were part of a cluster randomized control trial (RCT design for a federally funded longitudinal validation study of a particular program, English Language and Literacy Acquisition-Validation, ELLA- V, to determine its degree of impact on English oral language/literacy, reading, and science across 63 randomly assigned urban, suburban, and rural schools (first year of implementation. ELLA-V also examines the impact of bimonthly VPD for treatment teachers compared to comparison group teachers on pedagogical skills, measured by sound observation instruments, and on student achievement, measured by state/national English language/literacy/reading tests and a national science test. This study features extensive technology use via virtual observations, bimonthly VPD, and randomly assigned treatment and control schools with students served in English as second language (ESL instructional time. The study design and methodology are discussed relativeto the specialized uses of technology and issues involving the evaluation of technology’s contribution to the intervention of interest and of the efficient, cost-effective execution of the study.

  17. Sugammadex versus neostigmine in pediatric patients: a prospective randomized study

    Directory of Open Access Journals (Sweden)

    Turhan Kara

    2014-11-01

    Full Text Available Background and objectives: Acetylcholinesterase inhibitors may cause postoperative residual curarization when they are used for reversal of neuromuscular blockade. Sugammadex reverses neuromuscular blockade by chemical encapsulation and is not associated with the side effects that may occur with the use of anticholinesterase agents. Because of increased outpatient surgical procedures postoperative residual curarization and rapid postoperative recovery have a greater importance in the pediatric patient population. The aim of this study was to compare the efficacy of sugammadex and neostigmine on reversing neuromuscular blockade in pediatric patients undergoing outpatient surgical procedures. Methods: 80 patients, aged 2–12 years, scheduled for outpatient surgery were enrolled in this randomized prospective study. Neuromuscular blockade was achieved with 0.6 mg kg−1 rocuronium and monitorized with train-of-four. Group RN (n = 40 received 0.03 mg kg−1 neostigmine, Group RS (n = 40 received 2 mg kg−1 sugammadex for reversal of rocuronium. Extubation time (time from the reversal of neuromuscular blockade to extubation, train-of-four ratio during this time, time to reach train-of-four > 0.9, and probable complications were recorded. Results: There was no significant difference between the patients’ characteristics. Extubation time and time to reach train-of-four > 0.9 were significantly higher in Group RN (p = 0.001, p = 0.002. Train-of-four at the time of neostigmine/sugammadex injection in Group RN were significantly higher than in the RS group (p = 0.020. Extubation train-of-four ratio was significantly lower in Group RN (p = 0.002. Conclusion: Sugammadex provides safer extubation with a shorter recovery time than neostigmine in pediatric patients undergoing outpatient surgical procedures. Resumo: Justificativa e objetivos: Os inibidores da acetilcolinesterase podem causar curarização residual no p

  18. Prenatal emotion management improves obstetric outcomes: a randomized control study.

    Science.gov (United States)

    Huang, Jian; Li, He-Jiang; Wang, Jue; Mao, Hong-Jing; Jiang, Wen-Ying; Zhou, Hong; Chen, Shu-Lin

    2015-01-01

    Negative emotions can cause a number of prenatal problems and disturb obstetric outcomes. We determined the effectiveness of prenatal emotional management on obstetric outcomes in nulliparas. All participants completed the PHQ-9 at the baseline assessment. Then, the participants were randomly assigned to the emotional management (EM) and usual care (UC) groups. The baseline evaluation began at 31 weeks gestation and the participants were followed up to 42 days postpartum. Each subject in the EM group received an extra EM program while the participants in the UC groups received routine prenatal care and education only. The PHQ-9 and Edinburgh Postnatal Depression scale (EPDS) were used for assessment. The EM group had a lower PHQ-9 score at 36 weeks gestation, and 7 and 42 days after delivery (P Prenatal EM intervention could control anxiety and depressive feelings in nulliparas, and improve obstetric outcomes. It may serve as an innovative approach to reduce the cesarean section rate in China.

  19. A comparison of bivariate, multivariate random-effects, and Poisson correlated gamma-frailty models to meta-analyze individual patient data of ordinal scale diagnostic tests.

    Science.gov (United States)

    Simoneau, Gabrielle; Levis, Brooke; Cuijpers, Pim; Ioannidis, John P A; Patten, Scott B; Shrier, Ian; Bombardier, Charles H; de Lima Osório, Flavia; Fann, Jesse R; Gjerdingen, Dwenda; Lamers, Femke; Lotrakul, Manote; Löwe, Bernd; Shaaban, Juwita; Stafford, Lesley; van Weert, Henk C P M; Whooley, Mary A; Wittkampf, Karin A; Yeung, Albert S; Thombs, Brett D; Benedetti, Andrea

    2017-11-01

    Individual patient data (IPD) meta-analyses are increasingly common in the literature. In the context of estimating the diagnostic accuracy of ordinal or semi-continuous scale tests, sensitivity and specificity are often reported for a given threshold or a small set of thresholds, and a meta-analysis is conducted via a bivariate approach to account for their correlation. When IPD are available, sensitivity and specificity can be pooled for every possible threshold. Our objective was to compare the bivariate approach, which can be applied separately at every threshold, to two multivariate methods: the ordinal multivariate random-effects model and the Poisson correlated gamma-frailty model. Our comparison was empirical, using IPD from 13 studies that evaluated the diagnostic accuracy of the 9-item Patient Health Questionnaire depression screening tool, and included simulations. The empirical comparison showed that the implementation of the two multivariate methods is more laborious in terms of computational time and sensitivity to user-supplied values compared to the bivariate approach. Simulations showed that ignoring the within-study correlation of sensitivity and specificity across thresholds did not worsen inferences with the bivariate approach compared to the Poisson model. The ordinal approach was not suitable for simulations because the model was highly sensitive to user-supplied starting values. We tentatively recommend the bivariate approach rather than more complex multivariate methods for IPD diagnostic accuracy meta-analyses of ordinal scale tests, although the limited type of diagnostic data considered in the simulation study restricts the generalization of our findings. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  20. Comparisons for Effectiveness of Aromatherapy and Acupressure Massage on Quality of Life in Career Women: A Randomized Controlled Trial.

    Science.gov (United States)

    Kao, Yu-Hsiu; Huang, Yi-Ching; Chung, Ue-Lin; Hsu, Wen-Ni; Tang, Yi-Ting; Liao, Yi-Hung

    2017-06-01

    This study was aimed to compare the effectiveness of aromatherapy and acupressure massage intervention strategies on the sleep quality and quality of life (QOL) in career women. The randomized controlled trial experimental design was used in the present study. One hundred and thirty-two career women (24-55 years) voluntarily participated in this study and they were randomly assigned to (1) placebo (distilled water), (2) lavender essential oil (Lavandula angustifolia), (3) blended essential oil (1:1:1 ratio of L. angustifolia, Salvia sclarea, and Origanum majorana), and (4) acupressure massage groups for a 4-week treatment. The Pittsburgh Sleep Quality Index and Short Form 36 Health Survey were used to evaluate the intervention effects at pre- and postintervention. After a 4-week treatment, all experimental groups (blended essential oil, lavender essential oil, and acupressure massage) showed significant improvements in sleep quality and QOL (p aromatherapy and acupressure massage improve the sleep and QOL and may serve as the optimal means for career women to improve their sleep and QOL.

  1. A randomized 3-month clinical comparison of a power toothbrush to a manual toothbrush in the reduction of gingivitis.

    Science.gov (United States)

    Li, Zhen; He, Tao; Li, Chun; Sun, Lily; Chang, Jinlan; He, Yanyan; Zhao, Jizhi; Ji, Ning

    2016-08-01

    To compare the anti-gingivitis effect of a power toothbrush relative to a manual toothbrush control. This was a 3-month, randomized and controlled, single-center, parallel group, examiner-blinded clinical study. 123 Chinese adults in good general health and with at least 15 gingival bleeding sites, as measured by the Gingival Bleeding Index, were enrolled into the study. At baseline, pre-treatment gingivitis levels were assessed using the Mazza Bleeding Index. Subjects were then randomly assigned to receive either an oscillating-rotating power toothbrush [Oral-B Professional Care 7000 (D17u/EB17)] or a flat-trim manual toothbrush with tapered filaments (Lion Dentor Systema). Subjects brushed at home twice-daily with their assigned toothbrush and a marketed sodium fluoride dentifrice (Crest Cavity Protection dentifrice), and were reevaluated at Months 1, 2, and 3. 113 evaluable subjects completed the study. Both groups showed significant reductions in gingivitis from baseline for all time points measured (Pgingivitis reductions of 7.11%, 9.20% and 8.47%, respectively, than the manual toothbrush (Pgingivitis compared with a manual toothbrush at Months 1, 2 and 3.

  2. A randomized comparison of intraoperative PerfecTemp and forced-air warming during open abdominal surgery.

    Science.gov (United States)

    Egan, Cameron; Bernstein, Ethan; Reddy, Desigen; Ali, Madi; Paul, James; Yang, Dongsheng; Sessler, Daniel I

    2011-11-01

    The PerfecTemp is an underbody resistive warming system that combines servocontrolled underbody warming with viscoelastic foam pressure relief. Clinical efficacy of the system has yet to be formally evaluated. We therefore tested the hypothesis that intraoperative distal esophageal (core) temperatures with the PerfecTemp (underbody resistive) warming system are noninferior to upper-body forced-air warming in patients undergoing major open abdominal surgery under general anesthesia. Adults scheduled for elective major open abdominal surgery (liver, pancreas, gynecological, and colorectal surgery) under general anesthesia were enrolled at 2 centers. Patients were randomly assigned to underbody resistive or forced-air warming. Resistive heating started when patients were transferred to the operating room table; forced-air warming started after patients were draped. The primary outcome was noninferiority of intraoperative time-weighted average core temperature, adjusted for baseline characteristics and using a buffer of 0.5°C. Thirty-six patients were randomly assigned to underbody resistive heating and 34 to forced-air warming. Baseline and surgical characteristics were generally similar. We had sufficient evidence (P=0.018) to conclude that underbody resistive warming is not worse than (i.e., noninferior to) upper-body forced-air warming in the time-weighted average intraoperative temperature, with a mean difference of -0.12°C [95% confidence interval (CI) -0.37 to 0.14]. Core temperatures at the end of surgery averaged 36.3°C [95% CI 36 to 36.5] in the resistive warming patients and 36.6°C [95% CI 36.4 to 36.8] in those assigned to forced-air warming for a mean difference of -0.34°C [95% CI -0.69 to 0.01]. Mean intraoperative time-weighted average core temperatures were no different, and significantly noninferior, with underbody resistive heating in comparison with upper-body forced-air warming. Underbody resistive heating may be an alternative to forced

  3. Phase III Randomized Study of SB5, an Adalimumab Biosimilar, Versus Reference Adalimumab in Patients With Moderate‐to‐Severe Rheumatoid Arthritis

    OpenAIRE

    Weinblatt, Michael E.; Baranauskaite, Asta; Niebrzydowski, Jaroslaw; Dokoupilova, Eva; Zielinska, Agnieszka; Jaworski, Janusz; Racewicz, Artur; Pileckyte, Margarita; Jedrychowicz‐Rosiak, Krystyna; Cheong, Soo Yeon; Ghil, Jeehoon; Sokolovic, S.; Mekic, M.; Prodanovic, N.; Gajic, B.

    2017-01-01

    Objective SB5 is a biosimilar agent for adalimumab (ADA). The aim of this study was to evaluate the efficacy, pharmacokinetics (PK), safety, and immunogenicity of SB5 in comparison with reference ADA in patients with rheumatoid arthritis (RA). Methods In this phase III, randomized, double‐blind, parallel‐group study, patients with moderately to severely active RA despite treatment with methotrexate were randomized 1:1 to receive SB5 or reference ADA at a dosage of 40 mg subcutaneously every o...

  4. Efficacy of praziquantel against Schistosoma mekongi and Opisthorchis viverrini: a randomized, single-blinded dose-comparison trial.

    Directory of Open Access Journals (Sweden)

    Leonore Lovis

    Full Text Available BACKGROUND: Schistosomiasis and opisthorchiasis are of public health importance in Southeast Asia. Praziquantel (PZQ is the drug of choice for morbidity control but few dose comparisons have been made. METHODOLOGY: Ninety-three schoolchildren were enrolled in an area of Lao PDR where Schistosoma mekongi and Opisthorchis viverrini coexist for a PZQ dose-comparison trial. Prevalence and intensity of infections were determined by a rigorous diagnostic effort (3 stool specimens, each examined with triplicate Kato-Katz before and 28-30 days after treatment. Ninety children with full baseline data were randomized to receive PZQ: the 40 mg/kg standard single dose (n = 45 or a 75 mg/kg total dose (50 mg/kg+25 mg/kg, 4 hours apart; n = 45. Adverse events were assessed at 3 and 24 hours posttreatment. PRINCIPAL FINDINGS: Baseline infection prevalence of S. mekongi and O. viverrini were 87.8% and 98.9%, respectively. S. mekongi cure rates were 75.0% (95% confidence interval (CI: 56.6-88.5% and 80.8% (95% CI: 60.6-93.4% for 40 mg/kg and 75 mg/kg PZQ, respectively (P = 0.60. O. viverrini cure rates were significantly different at 71.4% (95% CI: 53.4-84.4% and 96.6% (95% CI: not defined, respectively (P = 0.009. Egg reduction rates (ERRs against O. viverrini were very high for both doses (>99%, but slightly lower for S. mekongi at 40 mg/kg (96.4% vs. 98.1% and not influenced by increasing diagnostic effort. O. viverrini cure rates would have been overestimated and no statistical difference between doses found if efficacy was based on a minimum sampling effort (single Kato-Katz before and after treatment. Adverse events were common (96%, mainly mild with no significant differences between the two treatment groups. CONCLUSIONS/SIGNIFICANCE: Cure rate from the 75 mg/kg PZQ dose was more efficacious than 40 mg/kg against O. viverrini but not against S. mekongi infections, while ERRs were similar for both doses. TRIAL REGISTRATION: Controlled

  5. Comparison of Clinical Efficacies of Preoperatively Initiated Naproxen Sodium-Codeine Phosphate in Combination, Diclofenac Potassium, and Benzydamine Hydrochloride for Pain, Edema, and Trismus After Extraction of Impacted Lower Third Molar: A Randomized Double-Blind Study.

    Science.gov (United States)

    Cigerim, Levent; Eroglu, Cennet Neslihan

    2018-03-01

    The aim of this study was to compare the clinical efficacies of naproxen sodium-codeine phosphate in combination, benzydamine hydrochloride, and diclofenac potassium for pain, edema, and trismus after lower third molar extraction. Ninety healthy volunteers in whom impacted third molar extraction was indicated were randomly distributed into 3 groups. One hour before the tooth-extraction process, patients were administered one of the following drugs: naproxen sodium, 550 mg, and codeine phosphate, 30 mg, in a tablet; diclofenac potassium, 50 mg, in a coated pill; or benzydamine hydrochloride, 50 mg, in a coated pill. Pain assessment was conducted via a visual analog scale; edema assessment, by measuring the distances between predetermined facial landmarks; and trismus assessment, by measuring interincisal distance. Regarding rescue analgesics (paracetamol, 500 mg), the number and time of use by patients were recorded. Naproxen sodium-codeine phosphate was more effective for pain, edema, and trismus than diclofenac potassium and benzydamine hydrochloride (P hydrochloride yielded similar clinical responses to diclofenac potassium (P > .05). No drug-related side effects were observed. Naproxen sodium-codeine phosphate constitutes the drug of choice after the extraction of a patient's impacted lower third molar. Benzydamine hydrochloride has similar efficacy to diclofenac potassium, and it can be used as a nonsteroidal anti-inflammatory analgesic drug. Copyright © 2017 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

  6. A randomized clinical trial on comparison of corticosteroid injection with or without splinting versus saline injection with or without splinting in patients with lateral epicondylitis

    Directory of Open Access Journals (Sweden)

    Mohammad Ali Tahririan

    2014-01-01

    Full Text Available Background: Lateral epicondylitis is a common problem affecting 1-3% of the population. There has been much debate about the best treatment modality for this condition. There is, however, no conclusive evidence in support of any of the proposed treatment modalities. In this trial, we have studied the effect of corticosteroid injection (with or without splinting with normal saline injection (with or without splinting. Materials and Methods: In this double-blind, randomized clinical trial, individuals were randomly assigned to either of four treatment groups and received either 40 mg depomedrol injection alone, 40 mg depomedrol injection with splinting, normal saline injection alone, or normal saline injection with splinting. They were evaluated using the visual analog scale (VAS at weeks 2, 4 and 24 and with the Oxford elbow scale (OES at 24 weeks. Results: A total of 79 patients were participated in the study. The corticosteroid injection groups had better pain relief as measured by VAS at 2 and 4 weeks compared with the two saline injection groups. Mean VAS difference at week 0 versus week 2 was 4.5 ± 0.9 and 2.8 ± 0.6 in corticosteroid injection groups and saline injection groups respectively (P < 0.01 but at 24 weeks, there was only moderate benefit reported for the group which received steroid injection and splinting (P < 0.01 compared to the saline injection groups. The saline injection groups reported better improvement in OES scores (20.1 ± 3.7 at the end of the trial compared corticosteroid injection groups (16.1 ± 2.9 (P < 0.05. Conclusion: Our results indicate that despite the clear pain reduction benefit associated with steroid injection in short term, this benefit in comparison with normal saline injection fades by the 24 th week of follow-up.

  7. Study protocol: a randomized controlled trial investigating the effects of a psychosexual training program for adolescents with autism spectrum disorder.

    Science.gov (United States)

    Visser, Kirsten; Greaves-Lord, Kirstin; Tick, Nouchka T; Verhulst, Frank C; Maras, Athanasios; van der Vegt, Esther J M

    2015-08-28

    Previous research shows that adolescents with autism spectrum disorder (ASD) run several risks in their psychosexual development and that these adolescents can have limited access to reliable information on puberty and sexuality, emphasizing the need for specific guidance of adolescents with ASD in their psychosexual development. Few studies have investigated the effects of psychosexual training programs for adolescents with ASD and to date no randomized controlled trials are available to study the effects of psychosexual interventions for this target group. The randomized controlled trial (RCT) described in this study protocol aims to investigate the effects of the Tackling Teenage Training (TTT) program on the psychosexual development of adolescents with ASD. This parallel clinical trial, conducted in the South-West of the Netherlands, has a simple equal randomization design with an intervention and a waiting-list control condition. Two hundred adolescents and their parents participate in this study. We assess the participants in both conditions using self-report as well as parent-report questionnaires at three time points during 1 year: at baseline (T1), post-treatment (T2), and for follow-up (T3). To our knowledge, the current study is the first that uses a randomized controlled design to study the effects of a psychosexual training program for adolescents with ASD. It has a number of methodological strengths, namely a large sample size, a wide range of functionally relevant outcome measures, the use of multiple informants, and a standardized research and intervention protocol. Also some limitations of the described study are identified, for instance not making a comparison between two treatment conditions, and no use of blinded observational measures to investigate the ecological validity of the research results. Dutch Trial Register NTR2860. Registered on 20 April 2011.

  8. Testing links between childhood positive peer relations and externalizing outcomes through a randomized controlled intervention study

    NARCIS (Netherlands)

    Witvliet, M.; van Lier, P.A.C.; Cuijpers, P.; Koot, H.M.

    2009-01-01

    In this study, the authors used a randomized controlled trial to explore the link between having positive peer relations and externalizing outcomes in 758 children followed from kindergarten to the end of 2nd grade. Children were randomly assigned to the Good Behavior Game (GBG), a universal

  9. Effects of Music Therapy on Drug Therapy of Adult Psychiatric Outpatients: A Pilot Randomized Controlled Study

    Science.gov (United States)

    Degli Stefani, Mario; Biasutti, Michele

    2016-01-01

    Objective: Framed in the patients’ engagement perspective, the current study aims to determine the effects of group music therapy in addition to drug care in comparison with drug care in addition to other non-expressive group activities in the treatment of psychiatric outpatients. Method: Participants (n = 27) with ICD-10 diagnoses of F20 (schizophrenia), F25 (schizoaffective disorders), F31 (bipolar affective disorder), F32 (depressive episode), and F60 (specific personality disorders) were randomized to receive group music therapy plus standard care (48 weekly sessions of 2 h) or standard care only. The clinical measures included dosages of neuroleptics, benzodiazepines, mood stabilizers, and antidepressants. Results: The participants who received group music therapy demonstrated greater improvement in drug dosage with respect to neuroleptics than those who did not receive group music therapy. Antidepressants had an increment for both groups that was significant only for the control group. Benzodiazepines and mood stabilizers did not show any significant change in either group. Conclusion: Group music therapy combined with standard drug care was effective for controlling neuroleptic drug dosages in adult psychiatric outpatients who received group music therapy. We discussed the likely applications of group music therapy in psychiatry and the possible contribution of music therapy in improving the psychopathological condition of adult outpatients. In addition, the implications for the patient-centered perspective were also discussed. PMID:27774073

  10. Assessment of fracture risk: value of random population-based samples--the Geelong Osteoporosis Study.

    Science.gov (United States)

    Henry, M J; Pasco, J A; Seeman, E; Nicholson, G C; Sanders, K M; Kotowicz, M A

    2001-01-01

    Fracture risk is determined by bone mineral density (BMD). The T-score, a measure of fracture risk, is the position of an individual's BMD in relation to a reference range. The aim of this study was to determine the magnitude of change in the T-score when different sampling techniques were used to produce the reference range. Reference ranges were derived from three samples, drawn from the same region: (1) an age-stratified population-based random sample, (2) unselected volunteers, and (3) a selected healthy subset of the population-based sample with no diseases or drugs known to affect bone. T-scores were calculated using the three reference ranges for a cohort of women who had sustained a fracture and as a group had a low mean BMD (ages 35-72 yr; n = 484). For most comparisons, the T-scores for the fracture cohort were more negative using the population reference range. The difference in T-scores reached 1.0 SD. The proportion of the fracture cohort classified as having osteoporosis at the spine was 26, 14, and 23% when the population, volunteer, and healthy reference ranges were applied, respectively. The use of inappropriate reference ranges results in substantial changes to T-scores and may lead to inappropriate management.

  11. Competence feedback improves CBT competence in trainee therapists: A randomized controlled pilot study.

    Science.gov (United States)

    Weck, Florian; Kaufmann, Yvonne M; Höfling, Volkmar

    2017-07-01

    The development and improvement of therapeutic competencies are central aims in psychotherapy training; however, little is known about which training interventions are suitable for the improvement of competencies. In the current pilot study, the efficacy of feedback regarding therapeutic competencies was investigated in cognitive behavioural therapy (CBT). Totally 19 trainee therapists and 19 patients were allocated randomly to a competence feedback group (CFG) or control group (CG). Two experienced clinicians and feedback providers who were blind to the treatment conditions independently evaluated therapeutic competencies on the Cognitive Therapy Scale at five treatment times (i.e., at Sessions 1, 5, 9, 13, and 17). Whereas CFG and CG included regular supervision, only therapists in the CFG additionally received written qualitative and quantitative feedback regarding their demonstrated competencies in conducting CBT during treatment. We found a significant Time × Group interaction effect (η² = .09), which indicates a larger competence increase in the CFG in comparison to the CG. Competence feedback was demonstrated to be suitable for the improvement of therapeutic competencies in CBT. These findings may have important implications for psychotherapy training, clinical practice, and psychotherapy research. However, further research is necessary to ensure the replicability and generalizability of the findings.

  12. Comparison of Two Regimens of RhG-CSF in Neutropenic Neonatal Septicemia: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Fatemeh Nayeri

    2011-09-01

    Full Text Available "nConsidering the 50% mortality rate of neonatal septicemia associated with neutropenia and increasing resistance to antibiotics, simultaneous antibiotic therapy strategies are becoming more important. However, few studies have been performed to evaluate effectiveness of RhG-CSF in the treatment of neutropenia in neonates. This randomized clinical trial was performed on 40 neutropenic neonates with septicemia who were hospitalized in Vali-e-Asr and Mirza Koochak Khan Hospitals (Tehran, Iran. The neonates were randomly divided into two equal groups RhG-CSF was administered as a subcutaneous single dose of 10μg/kg/s.c. to neonates in group A and as 10μg/kg/s.c./day once daily for 3 days to neonates in group B. CBC and differential count was checked 6, 24 and 48 hours after the last dose. There was no significant difference in mean birth weight, gender, age, and risk factors between two groups. Neutropenia was improved 48 hours after the last dose, whilst there was no significant statistical difference between two groups (P>0.05. The final outcome including death, duration of hospitalization and duration of antibiotics therapy after RhG-CSF administration did not differ between two groups (P>0.05. The results of this study showed that administration of a single dose of RhG-CSF (10μg/kg was effective in treating neonatal septicemic neutropenia.

  13. Comparison of two regimens of RhG-CSF in neutropenic neonatal septicemia: a randomized clinical trial.

    Science.gov (United States)

    Nayeri, Fatemeh; Soheili, Habib; Kaveh, Mahbod; Oloomi Yazdi, Zohre; Shariat, Mamak; Dalili, Hosein

    2011-01-01

    Considering the 50% mortality rate of neonatal septicemia associated with neutropenia and increasing resistance to antibiotics, simultaneous antibiotic therapy strategies are becoming more important. However, few studies have been performed to evaluate effectiveness of RhG-CSF in the treatment of neutropenia in neonates. This randomized clinical trial was performed on 40 neutropenic neonates with septicemia who were hospitalized in Vali-e-Asr and Mirza Koochak Khan Hospitals (Tehran, Iran). The neonates were randomly divided into two equal groups RhG-CSF was administered as a subcutaneous single dose of 10 μg/kg/s.c. to neonates in group A and as 10 μg/kg/s.c./day once daily for 3 days to neonates in group B. CBC and differential count was checked 6, 24 and 48 hours after the last dose. There was no significant difference in mean birth weight, gender, age, and risk factors between two groups. Neutropenia was improved 48 hours after the last dose, whilst there was no significant statistical difference between two groups (P>0.05). The final outcome including death, duration of hospitalization and duration of antibiotics therapy after RhG-CSF administration did not differ between two groups (P>0.05). The results of this study showed that administration of a single dose of RhG-CSF (10 μg/kg) was effective in treating neonatal septicemic neutropenia.

  14. Multiple comparisons in drug efficacy studies: scientific or marketing principles?

    Science.gov (United States)

    Leo, Jonathan

    2004-01-01

    When researchers design an experiment to compare a given medication to another medication, a behavioral therapy, or a placebo, the experiment often involves numerous comparisons. For instance, there may be several different evaluation methods, raters, and time points. Although scientifically justified, such comparisons can be abused in the interests of drug marketing. This article provides two recent examples of such questionable practices. The first involves the case of the arthritis drug celecoxib (Celebrex), where the study lasted 12 months but the authors only presented 6 months of data. The second case involves the NIMH Multimodal Treatment Study (MTA) study evaluating the efficacy of stimulant medication for attention-deficit hyperactivity disorder where ratings made by several groups are reported in contradictory fashion. The MTA authors have not clarified the confusion, at least in print, suggesting that the actual findings of the study may have played little role in the authors' reported conclusions.

  15. Random walk on random walks

    NARCIS (Netherlands)

    Hilário, M.; Hollander, den W.Th.F.; Sidoravicius, V.; Soares dos Santos, R.; Teixeira, A.

    2014-01-01

    In this paper we study a random walk in a one-dimensional dynamic random environment consisting of a collection of independent particles performing simple symmetric random walks in a Poisson equilibrium with density ¿¿(0,8). At each step the random walk performs a nearest-neighbour jump, moving to

  16. Omega-3 supplementation on inflammatory markers in patients with chronic Chagas cardiomyopathy: a randomized clinical study.

    Science.gov (United States)

    Silva, Paula Simplício da; Mediano, Mauro Felippe Felix; Silva, Gilberto Marcelo Sperandio da; Brito, Patricia Dias de; Cardoso, Claudia Santos de Aguiar; Almeida, Cristiane Fonseca de; Sangenis, Luiz Henrique Conde; Pinheiro, Roberta Olmo; Hasslocher-Moreno, Alejandro Marcel; Brasil, Pedro Emmanuel Alvarenga Americano do; Sousa, Andrea Silvestre de

    2017-06-09

    Several studies have been focusing on the effect of omega-3 polyunsaturated fatty acids on modulation of inflammatory markers in several cardiopathies. Although immunoregulatory dysfunction has been associated to the chronic cardiac involvement in Chagas disease, there is no study examining the effects of omega-3 supplementation in these patients. We investigated the effects of omega-3 PUFAs on markers of inflammation and lipid profile in chronic Chagas cardiomyopathy patients. The present study was a single-center double-blind clinical trial including patients with chronic Chagas cardiomyopathy. Patients were randomly assigned to receive omega-3 PUFAs capsules (1.8g EPA and 1.2g DHA) or placebo (corn oil) during an 8-week period. Cytokines, fasting glucose, lipid, and anthropometric profiles were evaluated. Forty-two patients (23 women and 19 men) were included in the study and there were only two losses to follow-up during the 8-week period. Most of sociodemographic and clinical characteristics were similar between the groups at baseline, except for the cytokines IL-1β, IL-6, IL-8, IL-10, IL-17α, and IFNγ. The omega-3 PUFAs group demonstrated greater improvements in serum triglycerides (-21.1 vs. -4.1; p = 0.05) and IL-10 levels (-10.6 vs. -35.7; p = 0.01) in comparison to controls after 8 weeks of intervention. No further differences were observed between groups. Omega-3 PUFAs supplementation may favorably affect lipid and inflammatory profile in chronic Chagas cardiomyopathy patients, demonstrated by a decrease in triglycerides and improvements on IL-10 concentration. Further studies examining the clinical effects of omega-3 fatty acids supplementation in chronic Chagas cardiomyopathy are necessary. NCT01863576.

  17. Effects of entonox in comparison of lidocaine on pain severity during episiotomy incision in nulliparous women: A randomized control trial

    Directory of Open Access Journals (Sweden)

    Azam Honarmandpour

    2017-01-01

    Full Text Available Background & Aim: Episiotomy is one of the most common surgical procedures in obstetrics, which requires analgesia. Entonox gas is known to have analgesic and sedative properties. However, no studies have been found on the analgesic effects of Entonox on episiotomy incision. Therefore, this study aimed to compare the effects of Entonox and lidocaine on pain intensity during episiotomy incision in nulliparous women. Materials and Methods: This randomized controlled trial was conducted on 120 term nulliparous women, who met the inclusion criteria. Subjects were selected by randomized sampling and equally divided into two groups of intervention and control (n=60. In the intervention group, Entonox gas was applied two minutes before episiotomy incision until the end of the procedure. On the other hand, the control group received 5 ml of lidocaine 2% as routine care before episiotomy incision. Data were collected using visual analogue scale to compare the study groups in terms of pain intensity. In addition, patient satisfaction with pain management technique during episiotomy and side effects of Entonox were assessed. Data analysis was performed in SPSS version 22 using Mann-Whitney U and Chi-square tests, and P value of less than 0.05 was considered statistically significant. Results: In this study, no significant difference was observed between the intervention and control groups regarding pain intensity (P=0.52. Moreover, no significant difference was observed in the satisfaction level of the two groups (P=0.70. Conclusion: According to the results of this study, Entonox could be used as an effective and noninvasive alternative to lidocaine to reduce pain during episiotomy incision without significant side effects.

  18. Rapid, easy, and cheap randomization: prospective evaluation in a study cohort

    Directory of Open Access Journals (Sweden)

    Parker Melissa J

    2012-06-01

    Full Text Available Abstract Background When planning a randomized controlled trial (RCT, investigators must select randomization and allocation procedures based upon a variety of factors. While third party randomization is cited as being among the most desirable randomization processes, many third party randomization procedures are neither feasible nor cost-effective for small RCTs, including pilot RCTs. In this study we present our experience with a third party randomization and allocation procedure that utilizes current technology to achieve randomization in a rapid, reliable, and cost-effective manner. Methods This method was developed by the investigators for use in a small 48-participant parallel group RCT with four study arms. As a nested study, the reliability of this randomization procedure was prospectively evaluated in this cohort. The primary outcome of this nested study was the proportion of subjects for whom allocation information was obtained by the Research Assistant within 15 min of the initial participant randomization request. A secondary outcome was the average time for communicating participant group assignment back to the Research Assistant. Descriptive information regarding any failed attempts at participant randomization as well as costs attributable to use of this method were also recorded. Statistical analyses included the calculation of simple proportions and descriptive statistics. Results Forty-eight participants were successfully randomized and group allocation instruction was received for 46 (96% within 15 min of the Research Assistant placing the initial randomization request. Time elapsed in minutes until receipt of participant allocation instruction was Mean (SD 3.1 +/− 3.6; Median (IQR 2 (2,3; Range (1–20 for the entire cohort of 48. For the two participants for whom group allocation information was not received by the Research Assistant within the 15-min pass threshold, this information was obtained following a second

  19. Comparison of Single Visit Post Endodontic Pain Using Mtwo Rotary and Hand K-File Instruments: A Randomized Clinical Trial.

    Science.gov (United States)

    Kashefinejad, Mohamad; Harandi, Azade; Eram, Saeed; Bijani, Ali

    2016-01-01

    Pain is an unpleasant outcome of endodontic treatment that can be unbearable to patients. Instrumentation techniques may affect the frequency and intensity of post-endodontic pain. This study aimed to compare single visit post endodontic pain using Mtwo (NiTi) rotary and hand K-file instruments. In this randomized controlled trial, 60 teeth with symptomatic irreversible pulpitis in 53 patients were selected and randomly assigned into two groups of 30 teeth. In group A, the root canals were prepared with Mtwo (NiTi) rotary instruments. In group B, the root canals were prepared with hand K-file instruments. Pain assessment was implemented using visual analog scale (VAS) at four, eight, 12 and 24 hours after treatment. The acquired data were analyzed using chi-square, Mann-Whitney U and Student's t-test (Protary instruments experienced significantly less post-endodontic pain than those treated with hand instruments (Protary instruments in root canal preparation contributed to lower incidence of postoperative pain than hand K-files.

  20. Comparison of Single Visit Post Endodontic Pain Using Mtwo Rotary and Hand K-File Instruments: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Mohamad Kashefinejad

    2016-08-01

    Full Text Available Objectives: Pain is an unpleasant outcome of endodontic treatment that can be unbearable to patients. Instrumentation techniques may affect the frequency and intensity of post-endodontic pain. This study aimed to compare single visit post endodontic pain using Mtwo (NiTi rotary and hand K-file instruments.Materials and Methods: In this randomized controlled trial, 60 teeth with symptomatic irreversible pulpitis in 53 patients were selected and randomly assigned into two groups of 30 teeth. In group A, the root canals were prepared with Mtwo (NiTi rotary instruments. In group B, the root canals were prepared with hand K-file instruments. Pain assessment was implemented using visual analog scale (VAS at four, eight, 12 and 24 hours after treatment. The acquired data were analyzed using chi-square, Mann-Whitney U and Student’s t-test (P<0.05.Results: Patients treated with rotary instruments experienced significantly less post-endodontic pain than those treated with hand instruments (P<0.001.Conclusion: The use of Mtwo (NiTi rotary instruments in root canal preparation contributed to lower incidence of postoperative pain than hand K-files.

  1. MRI in multiple sclerosis: an intra-individual, randomized and multicentric comparison of gadobutrol with gadoterate meglumine at 3 T

    Energy Technology Data Exchange (ETDEWEB)

    Saake, Marc; Weibart, Marina; Doerfler, Arnd [University of Erlangen-Nuremberg, Department of Neuroradiology, Erlangen (Germany); Langner, Soenke; Hosten, Norbert [University Medicine Greifswald, Institute for Diagnostic Radiology and Neuroradiology, Greifswald (Germany); Schwenke, Carsten [SCO:SSiS, Statistical Consulting, Berlin (Germany); Jansen, Olav [University of Kiel, Department of Radiology and Neuroradiology, Kiel (Germany)

    2016-03-15

    To compare contrast effects of gadobutrol with gadoterate meglumine for brain MRI in multiple sclerosis (MS) in a multicentre, randomized, prospective, intraindividual study at 3 T. Institutional review board approval was obtained. Patients with known or suspected active MS lesions were included. Two identical MRIs were performed using randomized contrast agent order. Four post-contrast T1 sequences were acquired (start time points 0, 3, 6 and 9 min). If no enhancing lesion was present in first MRI, second MRI was cancelled. Quantitative (number and signal intensity of enhancing lesions) and qualitative parameters (time points of first and all lesions enhancing; subjective preference regarding contrast enhancement and lesion delineation; global preference) were evaluated blinded. Seventy-four patients (male, 26; mean age, 35 years) were enrolled in three centres. In 45 patients enhancing lesions were found. Number of enhancing lesions increased over time for both contrast agents without significant difference (median 2 for both). Lesions signal intensity was significantly higher for gadobutrol (p < 0.05 at time points 3, 6 and 9 min). Subjective preference rating showed non-significant tendency in favour of gadobutrol. Both gadobutrol and gadoterate meglumine can be used for imaging of acute inflammatory MS lesions. However, gadobutrol generates higher lesion SI. (orig.)

  2. Comparison of single-dose nalbuphine versus tramadol for postoperative pain management in children: a randomized, controlled trial.

    Science.gov (United States)

    Liaqat, Naeem; Dar, Sajid Hameed

    2017-04-01

    Acute postoperative pain control in children is an essential component of postoperative care, particularly in daycare procedures. Giving patients continuous narcotic analgesics can be risky; however, a single dose may be sufficient. This study used a prospective, randomized controlled design and was conducted at the Pediatric Surgery Unit, Services Hospital, Lahore. In total, 150 patients who underwent inguinal herniotomy (age range: 1-12 years) were randomly assigned to two groups: group A (nalbuphine) and group B (tramadol). Patients were given a single dose of either nalbuphine (0.2 mg/kg) or tramadol (2 mg/kg) immediately after surgery and pain was measured at 0, 1, 2, 4, and 8 h. The demographic characteristics were similar between the two groups. The mean pain score was lower in group A than in group B at 0 and 1 h (P pain scores in group A were still lower, but not significantly. In all, 9 patients (12.0%) required rescue analgesics in group A compared to 16 patients (21.3%) in group B (P = 0.051). The mean time for requirement of rescue analgesics was 6.5 ± 0.5 h in group A and 5.3 ± 1.7 h in group B (P = 0.06). A single dose of nalbuphine is sufficient, and superior to tramadol, for postoperative pain management in children who have undergone daycare procedures.

  3. Comparison consequences of Jackson-Pratt drain versus chest tube after coronary artery bypass grafting: A randomized controlled clinical trial.

    Science.gov (United States)

    Mirmohammad-Sadeghi, Mohsen; Pourazari, Pejman; Akbari, Mojtaba

    2017-01-01

    Chest tubes are used in every case of coronary artery bypass grafting (CABG) to evacuate shed blood from around the heart and lungs. This study was designed to assess the effective of Jackson-Pratt drain in compare with conventional chest drains after CABG. This was a randomized controlled trial that conducted on 218 patients in Chamran hospital from February to December 2016. Eligible patients were randomized in a 1:1 ratio. Jackson-Pratt drain group had 109 patients who received a chest tube insertion in the pleural space of the left lung and a Jackson-Pratt drain in mediastinum, and Chest tube drainage group had 109 patients who received double chest tube insertion in the pleural space of the left lung and the mediastinum. The incidence of pleural effusions in Jackson-Pratt drain group and chest tube group were not statistically different. The pain score at 2-h in Drain group was significantly higher than chest tube group ( P = 0.001), but the trend of pain score between groups was not significantly different ( P = 0.097). The frequency of tamponade and atrial fibrillation (AF) were significantly lower in Jackson-Pratt drain group ( P drain is equally effective for preventing cardiac tamponade, pleural effusions, and pain intensity in patients after CABG when compared with conventional chest tubes, but was significantly superior regarding efficacy to hospital and Intensive Care Unit length of stay and the incidence of AF.

  4. Comparison of quality of obturation and instrumentation time using hand files and two rotary file systems in primary molars: A single-blinded randomized controlled trial.

    Science.gov (United States)

    Govindaraju, Lavanya; Jeevanandan, Ganesh; Subramanian, E M G

    2017-01-01

    In permanent dentition, different rotary systems are used for canal cleaning and shaping. Rotary instrumentation in pediatric dentistry is an emerging concept. A very few studies have compared the efficiency of rotary instrumentation for canal preparation in primary teeth. Hence, this study was performed to compare the obturation quality and instrumentation time of two rotary files systems - Protaper, Mtwo with hand files in primary molars. Forty-five primary mandibular molars were randomly allotted to one of the three groups. Instrumentation was done using K-files in Group 1; Protaper in Group 2; and Mtwo in Group 3. Instrumentation time was recorded. The canal filling quality was assessed as underfill, optimal fill, and overfill. Statistical analysis was done using Chi-square, ANOVA, and post hoc Tukey test. No significant difference was observed in the quality of obturation among three groups. Intergroup comparison of the instrumentation time showed a statistically significant difference between the three groups. The use of rotary instrumentation in primary teeth results in marked reduction in the instrumentation time and improves the quality of obturation.

  5. Experience from the comparison of two PSA-studies

    International Nuclear Information System (INIS)

    Holmberg, J.; Pulkkinen, U.

    2001-03-01

    Two probabilistic safety assessments (PSA) made for nearly identical reactors units (Forsmark 3 and Oskarshamn 3) have been compared. Two different analysis teams made the PSAs, and the analyses became quite different. The goal of the study is to identify, clarify and explain differences between PSA-studies. The purpose is to understand limitations and uncertainties in PSA, to explain reasons for differences between PSA-studies, and to give recommendations for comparison of PSA-studies and for improving the PSA-methodology. The reviews have been made by reading PSA-documentation, using the computer model and interviewing persons involved in the projects. The method and findings have been discussed within the project group. Both the PSA-project and various parts in the PSA-model have been reviewed. A major finding was that the two projects had different purpose and thus had different resources, scope and even methods in their study. The study shows that comparison of PSA results from different plants is normally not meaningful. It takes a very deep knowledge of the PSA studies to make a comparison of the results and usually one has to ensure that the compared studies have the same scope and are based on the same analysis methods. Harmonisation of the PSA-methodology is recommended in the presentation of results, presentation of methods, scope main limitation and assumption, and definitions for end states, initiating events and common cause failures. This would facilitate the comparison of the studies. Methods for validation of PSA for different application areas should be developed. The developed PSA review standards can be applied for a general validation of a study. The most important way to evaluate the real feasibility of PSA can take place only with practical applications. The PSA-documentation and models can be developed to facilitate the communication between PSA-experts and users. In any application consultation with the PSA-expert is however needed. Many

  6. A Randomized trial of an Asthma Internet Self-management Intervention (RAISIN): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Morrison, Deborah; Wyke, Sally; Thomson, Neil C; McConnachie, Alex; Agur, Karolina; Saunderson, Kathryn; Chaudhuri, Rekha; Mair, Frances S

    2014-05-24

    The financial costs associated with asthma care continue to increase while care remains suboptimal. Promoting optimal self-management, including the use of asthma action plans, along with regular health professional review has been shown to be an effective strategy and is recommended in asthma guidelines internationally. Despite evidence of benefit, guided self-management remains underused, however the potential for online resources to promote self-management behaviors is gaining increasing recognition. The aim of this paper is to describe the protocol for a pilot evaluation of a website 'Living well with asthma' which has been developed with the aim of promoting self-management behaviors shown to improve outcomes. The study is a parallel randomized controlled trial, where adults with asthma are randomly assigned to either access to the website for 12 weeks, or usual asthma care for 12 weeks (followed by access to the website if desired). Individuals are included if they are over 16-years-old, have a diagnosis of asthma with an Asthma Control Questionnaire (ACQ) score of greater than, or equal to 1, and have access to the internet. Primary outcomes for this evaluation include recruitment and retention rates, changes at 12 weeks from baseline for both ACQ and Asthma Quality of Life Questionnaire (AQLQ) scores, and quantitative data describing website usage (number of times logged on, length of time logged on, number of times individual pages looked at, and for how long). Secondary outcomes include clinical outcomes (medication use, health services use, lung function) and patient reported outcomes (including adherence, patient activation measures, and health status). Piloting of complex interventions is considered best practice and will maximise the potential of any future large-scale randomized controlled trial to successfully recruit and be able to report on necessary outcomes. Here we will provide results across a range of outcomes which will provide estimates of

  7. What Is Social Comparison and How Should We Study It?

    Science.gov (United States)

    Wood, Joanne V.

    1996-01-01

    Examines frequently used measures and procedures in social comparison research. The question of whether a method truly captures social comparison requires a clear understanding of what social comparison is; hence a definition of social comparison is proposed, multiple ancillary processes in social comparison are identified, and definitional…

  8. Systematic Review of Radiation Therapy Toxicity Reporting in Randomized Controlled Trials of Rectal Cancer: A Comparison of Patient-Reported Outcomes and Clinician Toxicity Reporting

    Energy Technology Data Exchange (ETDEWEB)

    Gilbert, Alexandra, E-mail: a.gilbert@leeds.ac.uk [Leeds Institute of Cancer & Pathology, University of Leeds, Leeds (United Kingdom); Ziegler, Lucy; Martland, Maisie [Leeds Institute of Cancer & Pathology, University of Leeds, Leeds (United Kingdom); Davidson, Susan [The Christie Hospital, Manchester (United Kingdom); Efficace, Fabio [Italian Group for Adult Hematologic Diseases, Rome (Italy); Sebag-Montefiore, David; Velikova, Galina [Leeds Institute of Cancer & Pathology, University of Leeds, Leeds (United Kingdom)

    2015-07-01

    The use of multimodal treatments for rectal cancer has improved cancer-related outcomes but makes monitoring toxicity challenging. Optimizing future radiation therapy regimens requires collection and publication of detailed toxicity data. This review evaluated the quality of toxicity information provided in randomized controlled trials (RCTs) of radiation therapy in rectal cancer and focused on the difference between clinician-reported and patient-reported toxicity. Medline, EMBASE, and the Cochrane Library were searched (January 1995-July 2013) for RCTs reporting late toxicity in patients treated with regimens including preoperative (chemo)radiation therapy. Data on toxicity measures and information on toxicity reported were extracted using Quantitative Analyses of Normal Tissue Effects in the Clinic recommendations. International Society for Quality of Life Research standards on patient-reported outcomes (PROs) were used to evaluate the quality of patient-reported toxicity. Twenty-one RCT publications met inclusion criteria out of 4144 articles screened. All PRO studies reported higher rates of toxicity symptoms than clinician-reported studies and reported on a wider range and milder symptoms. No clinician-reported study published data on sexual dysfunction. Of the clinician-reported studies, 55% grouped toxicity data related to an organ system together (eg “Bowel”), and 45% presented data only on more-severe (grade ≥3) toxicity. In comparison, all toxicity grades were reported in 79% of PRO publications, and all studies (100%) presented individual symptom toxicity data (eg bowel urgency). However, PRO reporting quality was variable. Only 43% of PRO studies presented baseline data, 28% did not use any psychometrically validated instruments, and only 29% of studies described statistical methods for managing missing data. Analysis of these trials highlights the lack of reporting standards for adverse events and reveals the differences between clinician and

  9. Prospective Randomized Comparison of the Effectiveness of Radiation Therapy and Local Steroid Injection for the Treatment of Plantar Fasciitis

    International Nuclear Information System (INIS)

    Canyilmaz, Emine; Canyilmaz, Fatih; Aynaci, Ozlem; Colak, Fatma; Serdar, Lasif; Uslu, Gonca Hanedan; Aynaci, Osman; Yoney, Adnan

    2015-01-01

    Purpose: The purpose of this study was to conduct a randomized trial of radiation therapy for plantar fasciitis and to compare radiation therapy with local steroid injections. Methods and Materials: Between March 2013 and April 2014, 128 patients with plantar fasciitis were randomized to receive radiation therapy (total dose of 6.0 Gy applied in 6 fractions of 1.0 Gy three times a week) or local corticosteroid injections a 1 ml injection of 40 mg methylprednisolone and 0.5 ml 1% lidocaine under the guidance of palpation. The results were measured using a visual analog scale, a modified von Pannewitz scale, and a 5-level function score. The fundamental phase of the study was 3 months, with a follow-up period of up to 6 months. Results: The median follow-up period for all patients was 12.5 months (range, 6.5-18.6 months). For the radiation therapy patients, the median follow-up period was 13 months (range, 6.5-18.5 months), whereas in the palpation-guided (PG) steroid injection arm, it was 12.1 months (range, 6.5-18.6 months). After 3 months, results in the radiation therapy arm were significantly superior to those in the PG steroid injection arm (visual analog scale, P<.001; modified von Pannewitz scale, P<.001; 5-level function score, P<.001). Requirements for a second treatment did not significantly differ between the 2 groups, but the time interval for the second treatment was significantly shorter in the PG steroid injection group (P=.045). Conclusion: This study confirms the superior analgesic effect of radiation therapy compared to mean PG steroid injection on plantar fasciitis for at least 6 months after treatment

  10. Prospective Randomized Comparison of the Effectiveness of Radiation Therapy and Local Steroid Injection for the Treatment of Plantar Fasciitis

    Energy Technology Data Exchange (ETDEWEB)

    Canyilmaz, Emine, E-mail: dremocan@ktu.edu.tr [Department of Radiation Oncology, Faculty of Medicine, Karadeniz Technical University, Trabzon (Turkey); Canyilmaz, Fatih [Department of Orthopaedics and Traumatology, Yavuz Selim Bone Disease and Rehabilitation Hospital, Trabzon (Turkey); Aynaci, Ozlem; Colak, Fatma; Serdar, Lasif [Department of Radiation Oncology, Faculty of Medicine, Karadeniz Technical University, Trabzon (Turkey); Uslu, Gonca Hanedan [Department of Radiation Oncology, Kanuni Research and Education Hospital, Trabzon (Turkey); Aynaci, Osman [Department of Orthopaedics and Traumatology, Faculty of Medicine, Karadeniz Technical University, Trabzon (Turkey); Yoney, Adnan [Department of Radiation Oncology, Faculty of Medicine, Karadeniz Technical University, Trabzon (Turkey)

    2015-07-01

    Purpose: The purpose of this study was to conduct a randomized trial of radiation therapy for plantar fasciitis and to compare radiation therapy with local steroid injections. Methods and Materials: Between March 2013 and April 2014, 128 patients with plantar fasciitis were randomized to receive radiation therapy (total dose of 6.0 Gy applied in 6 fractions of 1.0 Gy three times a week) or local corticosteroid injections a 1 ml injection of 40 mg methylprednisolone and 0.5 ml 1% lidocaine under the guidance of palpation. The results were measured using a visual analog scale, a modified von Pannewitz scale, and a 5-level function score. The fundamental phase of the study was 3 months, with a follow-up period of up to 6 months. Results: The median follow-up period for all patients was 12.5 months (range, 6.5-18.6 months). For the radiation therapy patients, the median follow-up period was 13 months (range, 6.5-18.5 months), whereas in the palpation-guided (PG) steroid injection arm, it was 12.1 months (range, 6.5-18.6 months). After 3 months, results in the radiation therapy arm were significantly superior to those in the PG steroid injection arm (visual analog scale, P<.001; modified von Pannewitz scale, P<.001; 5-level function score, P<.001). Requirements for a second treatment did not significantly differ between the 2 groups, but the time interval for the second treatment was significantly shorter in the PG steroid injection group (P=.045). Conclusion: This study confirms the superior analgesic effect of radiation therapy compared to mean PG steroid injection on plantar fasciitis for at least 6 months after treatment.

  11. Comparison of Invasive and Noninvasive Mechanical Ventilation for Patients with COPD:Randomised Prospective Study

    Directory of Open Access Journals (Sweden)

    Ivo Matic

    2008-01-01

    Full Text Available Acute respiratory failure due to chronic obstructive pulmonary disease presents an increasing problem for both health and economics in the modern world. The goal of this study was to compare invasive and noninvasive mechani-cal ventilation for patients with COPD. A prospective, randomized trial was performed in a multidisciplinary intensive care unit. Of 614 patients requiring mechanical ventilation (MV longer than 24h, after excluding those who didn′t meet the inclusion criteria, 72 patients with COPD remained the research sample. The MV procedure was per-formed using standard methods, applying two MV methods: invasive MV and noninvasive MV. Patients were ran-domized into two groups for MV application using closed, non transparent envelopes. Comparison was made based on patient characteristics, objective parameters 1h, 4h, 24h, and 48h after admission and finally treatment outcome. In patients with COPD NIMV had statistically better outcome compared to IMV with MV duration NIMV:IMV 102:187h, p < 0.001, time spent in ICU 127:233h, p < 0.001. Need for intubation/reintubation 16 (42.1%:34 (100%/4 (11.8%, p < 0.001, hospital pneumonia 2 (5.3%:18 (52.9%, p =0.001. Applying strict application protocols, and based on com-parison of objective parameters of pulmonary mechanics, biochemistry and finally treatment outcome, high advantage of NIMV method was confirmed.

  12. Comparative analysis of conventional and eversion carotid endarterectomy: Prospective randomized study

    Directory of Open Access Journals (Sweden)

    Marković Dragan M.

    2008-01-01

    Full Text Available INTRODUCTION Studies completed in the last decade of the 20th century showed benefits of carotid endarterectomy in the prevention of stroke in patients with a high-grade stenosis of the internal carotid artery. OBJECTIVE The aim of this prospective, randomized study was the comparison of early and long-term results between the conventional and eversion carotid endarterectomy, and literature review. METHOD By the method of random choice, 103 patients were operated on using the eversion carotid endarterectomy and 98 patients using the conventional technique. Operative treatment was carried out under general anaesthesia. Following the clammping of the carotid artery, retrograde blood pressure was determined by a direct puncture of the internal carotid artery above the stenotic lesions. In patients with retrograde pressure below 20 mm Hg intraluminal shunting was routinely performed. Early results were estimated (during the first seven postoperative days based on mortality, central neurological complications (stroke, TIA and cranial or cervical nerve lesions. Long-term results were estimated (after at least two years based on long-term survival rate, central neurological complications (stroke, TIA and the incidence of haemodynamically significant restenosis of the carotid artery treated by endarterectomy. RESULTS The average time of clamming of the internal carotid artery in the eversion carotid anderectomy group was 5.36 minutes shorter than in the group treated by the conventional technique. Student's t-test showed a statistically highly significant difference in the time needed for clamming of the internal carotid artery between the two groups. The average duration of eversion endarterectomy (82 minutes was most often 19 minutes shorter than the duration of the conventional endarterectomy (101 minutes. Student's t-test showed a statistically highly significant difference in the average length of surgeries. The distal intimal fixation was more

  13. Design, rationale, and baseline demographics of SEARCH I: a prospective cluster-randomized study

    Directory of Open Access Journals (Sweden)

    Albers F

    2012-07-01

    Full Text Available Frank Albers,1 Asif Shaikh,2 Ahmar Iqbal,31Medical Affairs Respiratory, 2Clinical Development and Medical Affairs, Field Based Medicine-Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA; 3Respiratory Medical Affairs, Pfizer Inc, New York, NY, USAAbstract: Questionnaires are available to identify patients at risk for several chronic diseases, including COPD, but are infrequently utilized in primary care. COPD is often underdiagnosed, while at the same time the US Preventive Services Task Force recommends against spirometric screening for COPD in asymptomatic adults. Use of a symptom-based questionnaire and subsequent handheld spirometric device depending on the answers to the questionnaire is a promising approach to identify patients at risk for COPD. Screening, Evaluating and Assessing Rate CHanges of diagnosing respiratory conditions in primary care 1 (SEARCH I was a prospective cluster-randomized study in 168 US primary care practices evaluating the effect of the COPD-Population Screener (COPD-PS™ questionnaire. The effect of this questionnaire alone or sequentially with the handheld copd-6TM device was evaluated on new diagnoses of COPD and on respiratory diagnostic practice patterns (including referrals for pulmonary function testing, referrals to pulmonologists, new diagnoses of COPD, and new respiratory medication prescriptions. Participating practices entered a total of 9704 consecutive consenting subjects aged ≥ 40 years attending primary care clinics. Study arm results were compared for new COPD diagnosis rates between usual care and (1 COPD-PS plus copd-6 and (2 COPD-PS alone. A cluster-randomization design allowed comparison of the intervention effects at the practice level instead of individuals being the subjects of the intervention. Regional principal investigators controlled the flow of study information to sub-investigators at participating practices to reduce observation bias (Hawthorne effect. The

  14. Studies in astronomical time series analysis: Modeling random processes in the time domain

    Science.gov (United States)

    Scargle, J. D.

    1979-01-01

    Random process models phased in the time domain are used to analyze astrophysical time series data produced by random processes. A moving average (MA) model represents the data as a sequence of pulses occurring randomly in time, with random amplitudes. An autoregressive (AR) model represents the correlations in the process in terms of a linear function of past values. The best AR model is determined from sampled data and transformed to an MA for interpretation. The randomness of the pulse amplitudes is maximized by a FORTRAN algorithm which is relatively stable numerically. Results of test cases are given to study the effects of adding noise and of different distributions for the pulse amplitudes. A preliminary analysis of the optical light curve of the quasar 3C 273 is given.

  15. Comparison of novel lipid-based eye drops with aqueous eye drops for dry eye: a multicenter, randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Simmons PA

    2015-04-01

    Full Text Available Peter A Simmons, Cindy Carlisle-Wilcox, Joseph G Vehige Ophthalmology Research and Development, Allergan, Inc., Irvine, CA, USA Background: Dry eye may be caused or exacerbated by deficient lipid secretion. Recently, lipid-containing artificial tears have been developed to alleviate this deficiency. Our study compared the efficacy, safety, and acceptability of lipid-containing eye drops with that of aqueous eye drops.Methods: A non-inferiority, randomized, parallel-group, investigator-masked multicenter trial was conducted. Subjects with signs and symptoms of dry eye were randomized to use one of two lipid-containing artificial tears, or one of two aqueous artificial tears. Subjects instilled assigned drops in each eye at least twice daily for 30 days. The primary efficacy analysis tested non-inferiority of a preservative-free lipid tear formulation (LT UD to a preservative-free aqueous tear formulation (AqT UD for change in Ocular Surface Disease Index (OSDI score from baseline at day 30. Secondary measures included OSDI at day 7, tear break-up time (TBUT, corneal and conjunctival staining, Schirmer’s test, acceptability and usage questionnaires, and safety assessments.Results: A total of 315 subjects were randomized and included in the analyses. Subjects reported instilling a median of three doses of study eye drops per day in all groups. At days 7 and 30, all groups showed statistically significant improvements from baseline in OSDI (P<0.001 and TBUT (P≤0.005. LT UD was non-inferior to AqT UD for mean change from baseline in OSDI score at day 30. No consistent or clinically relevant differences for the other efficacy variables were observed. Acceptability was generally similar across the groups and there was a low incidence of adverse events.Conclusion: In this heterogeneous population of dry eye subjects, there were no clinically significant differences in safety, effectiveness, and acceptability between lipid-containing artificial tears

  16. Benfotiamine in treatment of alcoholic polyneuropathy: an 8-week randomized controlled study (BAP I Study).

    Science.gov (United States)

    Woelk, H; Lehrl, S; Bitsch, R; Köpcke, W

    1998-01-01

    A three-armed, randomized, multicentre, placebo-controlled double-blind study was used to examine the efficacy of benfotiamine vs a combination containing benfotiamine and vitamins B6 and B12 in out-patients with severe symptoms of alcoholic polyneuropathy (Benfotiamine in treatment of Alcoholic Polyneuropathy, BAP I). The study period was 8 weeks and 84 patients fulfilled all the prerequisite criteria and completed the study as planned. Benfotiamine led to significant improvement of alcoholic polyneuropathy. Vibration perception (measured at the tip of the great toe) significantly improved in the course of the study, as did motor function. and the overall score reflecting the entire range of symptoms of alcoholic polyneuropathy. A tendency toward improvement was evident for pain and co-ordination; no therapy-specific adverse effects were seen.

  17. Random Telegraph Signal Amplitudes in Sub 100 nm (Decanano) MOSFETs: A 3D 'Atomistic' Simulation Study

    Science.gov (United States)

    Asenov, Asen; Balasubramaniam, R.; Brown, A. R.; Davies, J. H.; Saini, Subhash

    2000-01-01

    In this paper we use 3D simulations to study the amplitudes of random telegraph signals (RTS) associated with the trapping of a single carrier in interface states in the channel of sub 100 nm (decanano) MOSFETs. Both simulations using continuous doping charge and random discrete dopants in the active region of the MOSFETs are presented. We have studied the dependence of the RTS amplitudes on the position of the trapped charge in the channel and on the device design parameters. We have observed a significant increase in the maximum RTS amplitude when discrete random dopants are employed in the simulations.

  18. Comparison of the effect of glycerol and triamcinolone acetonide on cumulative skin irritation in a randomized trial

    DEFF Research Database (Denmark)

    Andersen, Flemming; Hedegaard, Kathryn; Petersen, Thomas Kongstad

    2007-01-01

    BACKGROUND: So-called anti-irritants are added to cosmetic formulations because of their alleged beneficial effect on irritated skin. Documentation for these claims is often limited. However, glycerol has shown anti-irritant properties in experimentally induced irritation from sodium lauryl sulfate...... volunteers. METHODS: Irritation was induced by 3 daily arm washes for a week with 10% sodium lauryl sulfate on one arm and 30% NON on the other. To maintain irritation, for the next 12 days volunteers washed their arms twice daily with the irritants. Treatments were applied immediately after washing....... The treatments (including vehicle and no treatment) were randomized to sites using a Latin square design. The reactions were evaluated clinically and instrumentally. LIMITATIONS: Study was designed to only detect potent anti-irritants. CONCLUSION: Glycerol reduced the irritant effect of both sodium lauryl...

  19. A randomized comparison of physical performance following laparoscopic and open inguinal hernia repair. The Coala Trial Group.

    Science.gov (United States)

    Liem, M S; van der Graaf, Y; Zwart, R C; Geurts, I; van Vroonhoven, T J

    1997-01-01

    Return to normal activity after laparoscopic inguinal hernia repair has been reported to occur sooner than after conventional repair. As part of a randomized study, the ability of patients to return to normal activity was assessed by measuring abdominal muscular performance with an exercise test. In addition, patients completed a questionnaire concerning activities of daily life (ADL) and were asked when they returned to normal activities. All patients were given similar instructions for resumption of activities. Patients who had a laparoscopic repair returned to normal activities sooner (6 versus 10 days; P = 0.0003). One week after operation, these patients were able to perform more repetitions of both exercise (14 versus two straight leg raises; 16 versus seven curled sit ups; both P < 0.0001) and their ADL scores were significantly better (89 versus 72; P = 0.0001). Laparoscopic hernia repair results in a quicker recovery.

  20. Liquid metal reactor/Pressurized water reactor plant comparison study

    International Nuclear Information System (INIS)

    Halverson, T.G.

    1986-01-01

    The selection between alternative electric power generating technologies is mainly based on their overall economics. Capital costs account for over 60% of the total busbar cost of nuclear plants. Estimates reported in the literature have shown capital cost ratios of LMRs to PWRs ranging from less than 1 to as high as 1.8. To reduce this range of uncertainty, the study selected a method for cataloging plant hardware and then performed comparisons using engineering judgment as to the anticipated and reasonable cost differences. The paper summarizes the resulting one-on-one comparisons of components, systems, and buildings and identifies the LMR-PWR similarities and differences which influence costs. The study leads to the conclusion that the capital cost of the most up-to-date large LMR design would be very close to that of the latest PWRs

  1. Comparison of 3 Different Teaching Methods for a Behavioral Therapy Program for Female Overactive Bladder: A Randomized Controlled Trial.

    Science.gov (United States)

    Gezginci, Elif; Iyigun, Emine; Yilmaz, Sercan

    The purpose of this study was to compare the effect of 3 instructional methods for behavioral therapy on lower urinary tract symptom (LUTS) severity and health-related quality of life (HRQOL) in women with overactive bladder. Single-center, parallel-group, randomized, clinical trial. The sample comprised 60 women diagnosed with overactive bladder. The study setting was a university-based female urology clinic in Ankara, Turkey; data were collected from November 2012 to May 2013. Eligible participants were ambulatory women 18 years or older with predominant overactive bladder and urge urinary incontinence (UI) symptoms, with or without stress UI symptoms. Subjects were randomized into 4 groups based on educational intervention; group 1 received structured verbal instruction plus a leaflet, group 2 received structured verbal instruction, group 3 received a leaflet alone, and group 4 received usual care that included unstructured verbal counseling about continence care. The primary outcome measures were Incontinence Impact Questionnaire-7 (IIQ-7) and Urinary Distress Inventory-6 (UDI-6) scores. We also measured changes in UI-specific HRQOL scores via the Urinary Incontinence Quality of Life Instrument (I-QOL). All outcomes were measured before and 6 to 8 weeks after the interventions. The Wilcoxon test was used to identify differences in LUTS severity and HRQOL before and after the educational intervention. The Kruskall-Wallis test was used to compare differences among the groups. The severity of LUTS and UI-specific quality of life assessed by the IIQ-7, UDI-6, and I-QOL scores significantly improved after training in all 4 groups (P women with overactive bladder and urge UI.

  2. An alternative approach to treating lateral epicondylitis. A randomized, placebo-controlled, double-blinded study

    NARCIS (Netherlands)

    Nourbakhsh, Mohammad Reza; Fearon, Frank J.

    Objective: To investigate the effect of noxious level electrical stimulation on pain, grip strength and functional abilities in subjects with chronic lateral epicondylitis. Design: Randomized, placebo-control, double-blinded study. Setting: Physical Therapy Department, North Georgia College and

  3. Comparison of Effectiveness of Supervised Exercise Program and Cyriax Physiotherapy in Patients with Tennis Elbow (Lateral Epicondylitis): A Randomized Clinical Trial

    Science.gov (United States)

    Viswas, Rajadurai; Ramachandran, Rejeeshkumar; Korde Anantkumar, Payal

    2012-01-01

    Objective. To compare the effectiveness of supervised exercise program and Cyriax physiotherapy in the treatment of tennis elbow (lateral epicondylitis). Design. Randomized clinical trial. Setting. Physiotherapy and rehabilitation centre. Subjects. This study was carried out with 20 patients, who had tennis elbow (lateral epicondylitis). Intervention. Group A (n = 10) had received supervised exercise program. Group B (n = 10) was treated with Cyriax physiotherapy. All patients received three treatment sessions per week for four weeks (12 treatment sessions). Outcome measures. Pain was evaluated using a visual analogue scale (VAS), and functional status was evaluated by completion of the Tennis Elbow Function Scale (TEFS) which were recorded at base line and at the end of fourth week. Results. Both the supervised exercise program and Cyriax physiotherapy were found to be significantly effective in reduction of pain and in the improvement of functional status. The supervised exercise programme resulted in greater improvement in comparison to those who received Cyriax physiotherapy. Conclusion. The results of this clinical trial demonstrate that the supervised exercise program may be the first treatment choice for therapist in managing tennis elbow. PMID:22629225

  4. Comparison of Effectiveness of Supervised Exercise Program and Cyriax Physiotherapy in Patients with Tennis Elbow (Lateral Epicondylitis: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Rajadurai Viswas

    2012-01-01

    Full Text Available Objective. To compare the effectiveness of supervised exercise program and Cyriax physiotherapy in the treatment of tennis elbow (lateral epicondylitis. Design. Randomized clinical trial. Setting. Physiotherapy and rehabilitation centre. Subjects. This study was carried out with 20 patients, who had tennis elbow (lateral epicondylitis. Intervention. Group A (=10 had received supervised exercise program. Group B (=10 was treated with Cyriax physiotherapy. All patients received three treatment sessions per week for four weeks (12 treatment sessions. Outcome measures. Pain was evaluated using a visual analogue scale (VAS, and functional status was evaluated by completion of the Tennis Elbow Function Scale (TEFS which were recorded at base line and at the end of fourth week. Results. Both the supervised exercise program and Cyriax physiotherapy were found to be significantly effective in reduction of pain and in the improvement of functional status. The supervised exercise programme resulted in greater improvement in comparison to those who received Cyriax physiotherapy. Conclusion. The results of this clinical trial demonstrate that the supervised exercise program may be the first treatment choice for therapist in managing tennis elbow.

  5. Effectiveness of Wii-based rehabilitation in stroke: A randomized controlled study

    OpenAIRE

    Ayça Utkan Karasu; Elif Balevi Batur; Gülçin Kaymak Karataş

    2018-01-01

    Objective: To investigate the efficacy of Nintendo Wii Fit®-based balance rehabilitation as an adjunc-tive therapy to conventional rehabilitation in stroke patients. Methods: During the study period, 70 stroke patients were evaluated. Of these, 23 who met the study criteria were randomly assigned to either the experimental group (n = 12) or the control group (n = 11) by block randomization. Primary outcome measures were Berg Balance Scale, Functional Reach Test, Postural Asses...

  6. Comparison of the efficacy and safety of thrombectomy devices in acute stroke : a network meta-analysis of randomized trials.

    Science.gov (United States)

    Saber, Hamidreza; Rajah, Gary B; Kherallah, Riyad Y; Jadhav, Ashutosh P; Narayanan, Sandra

    2017-12-15

    Mechanical thrombectomy (MT) is increasingly used for large-vessel occlusions (LVO), but randomized clinical trial (RCT) level data with regard to differences in clinical outcomes of MT devices are limited. We conducted a network meta-analysis (NMA) that enables comparison of modern MT devices (Trevo, Solitaire, Aspiration) and strategies (stent retriever vs aspiration) across trials. Relevant RCTs were identified by a systematic review. The efficacy outcome was 90-day functional independence (modified Rankin Scale (mRS) score 0-2). Safety outcomes were 90-day catastrophic outcome (mRS 5-6) and symptomatic intracranial hemorrhage (sICH). Fixed-effect Bayesian NMA was performed to calculate risk estimates and the rank probabilities. In a NMA of six relevant RCTs (SWIFT, TREVO2, EXTEND-IA, SWIFT-PRIME, REVASCAT, THERAPY; total of 871 patients, 472 Solitaire vs medical-only, 108 Aspiration vs medical-only, 178 Trevo vs Merci, and 113 Solitaire vs Merci) with medical-only arm as the reference, Trevo had the greatest functional independence (OR 4.14, 95% credible interval (CrI) 1.41-11.80; top rank probability 92%) followed by Solitaire (OR 2.55, 95% CrI 1.75-3.74; top rank probability 72%). Solitaire and Aspiration devices had the greatest top rank probability with respect to low sICH and catastrophic outcomes (76% and 91%, respectively), but without significant differences between each other. In a separate network of seven RCTs (MR-CLEAN, ESCAPE, EXTEND-IA, SWIFT-PRIME, REVASCAT, THERAPY, ASTER; 1737 patients), first-line stent retriever was associated with a higher top rank probability of functional independence than aspiration (95% vs 54%), with comparable safety outcomes. These findings suggest that Trevo and Solitaire devices are associated with a greater likelihood of functional independence whereas Solitaire and Aspiration devices appear to be safer. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights

  7. The Move from Accuracy Studies to Randomized Trials in PET

    DEFF Research Database (Denmark)

    Siepe, Bettina; Hoilund-Carlsen, Poul Flemming; Gerke, Oke

    2014-01-01

    an important role in informing guideline developers and policy makers. Our aim was to investigate how far the nuclear medicine community has come on its way from accuracy studies to RCTs and which issues we have to take into account in planning future studies. METHODS: We conducted a systematic review...... evaluation. Choice of patient-important outcomes and sufficient sample sizes are crucial issues in planning RCTs to demonstrate the clinical benefit of using PET....

  8. Randomized, Double-blind Study with Glycerol and Paraffin in Uremic Xerosis

    Science.gov (United States)

    Balaskas, Elias; Szepietowski, Jacek C.; Bessis, Didier; Ioannides, Dimitrios; Ponticelli, Claudio; Ghienne, Corinne; Taberly, Alain

    2011-01-01

    Summary Background and objectives Uremic xerosis is a bothersome condition that is poorly responsive to moisturizing and emollient therapy. Design, setting, participants, & measurements A randomized, double-blind, intraindividual (left versus right comparison), multicentric clinical study was performed on 100 patients with moderate to severe uremic xerosis for 7 days, during which the patients applied twice daily an emulsion combining glycerol and paraffin (test product) on one allocated lower leg, and the emulsion alone (comparator) on the other lower leg. This was followed by an open-labeled use of the test product on all of the xerotic areas for 49 days. The main efficacy parameter was treatment response on each lower leg, as defined by a reduction from baseline of at least two grades in a five-point clinical score on day 7. Results Among the 99 patients analyzed, the test product was highly effective with a treatment response in 72 patients (73%), whereas 44 patients (44%) responded to the comparator (P < 0.0001, intergroup analysis). This was associated with an objective reduction in the density and thickness of the scales on day 7 (P < 0.0001 compared with the comparator) and a substantial improvement of the uremic pruritus (75%) and quality of life of the patients at study end (P < 0.001, intragroup analysis). The test product was very well tolerated, with product-related local intolerance (exacerbated pruritus, local burning, or erythema) occurring in only five patients (5%). Conclusions Uremic xerosis can be managed successfully when an appropriate emollient therapy is used. PMID:21258039

  9. Hypnosis for hot flashes among postmenopausal women study: A study protocol of an ongoing randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Johnson Aimee K

    2011-10-01

    Full Text Available Abstract Background Hot flashes are a highly prevalent problem associated with menopause and breast cancer treatments. The recent findings from the Women's Health Initiative have important implications for the significance of a non-hormonal, mind-body intervention for hot flashes in breast cancer survivors. Women who take hormone therapy long-term may have a 1.2 to 2.0 fold increased risk of developing breast cancer. In addition, it is now known that hormone therapy with estrogen and progestin is associated with increased risk of cardiovascular disease and stroke. Currently there are limited options to hormone replacement therapy as non-hormonal pharmacological agents are associated with only modest activity and many adverse side effects. Because of this there is a need for more alternative, non-hormonal therapies. Hypnosis is a mind-body intervention that has been shown to reduce self-reported hot flashes by up to 68% among breast cancer survivors, however, the use of hypnosis for hot flashes among post-menopausal women has not been adequately explored and the efficacy of hypnosis in reducing physiologically measured hot flashes has not yet been determined. Methods/design A sample of 180 post-menopausal women will be randomly assigned to either a 5-session Hypnosis Intervention or 5-session structured-attention control with 12 week follow-up. The present study will compare hypnosis to a structured-attention control in reducing hot flashes (perceived and physiologically monitored in post-menopausal women in a randomized clinical trial. Outcomes will be hot flashes (self-report daily diaries; physiological monitoring; Hot Flash Related Daily Interference Scale, anxiety (State-Trait Anxiety Inventory; Hospital Anxiety and Depression Scale (HADS; anxiety visual analog scale (VAS rating; depression (Center for Epidemiologic Studies Depression Scale, sexual functioning (Sexual Activity Questionnaire, sleep quality (Pittsburgh Sleep Quality Index and

  10. A Randomized Controlled Comparison of Integrative Cognitive-Affective Therapy and Cognitive-Behavioral Therapy-Enhanced for Bulimia Nervosa

    Science.gov (United States)

    Wonderlich, Stephen A.; Peterson, Carol B.; Crosby, Ross D.; Smith, Tracey L.; Klein, Marjorie H.; Mitchell, James E.; Crow, Scott J.

    2016-01-01

    Background The purpose of this investigation was to compare a new psychotherapy for bulimia nervosa, Integrative Cognitive-Affective Therapy (ICAT), with an established treatment, Cognitive-Behavioral Therapy-Enhanced (CBT-E). Method Eighty adults with symptoms of bulimia nervosa were randomized to ICAT or CBT-E for 21 sessions over 19 weeks. Bulimic symptoms, measured by the Eating Disorder Examination, were assessed at baseline, end of treatment, and 4-month follow-up. Treatment outcome, as measured by binge eating frequency, purging frequency, global eating disorder severity, emotion regulation, self-oriented cognition, depression, anxiety, and self-esteem, was determined using generalized estimating equations, logistic regression, and a general linear model (intent-to-treat). Results Both treatments were associated with significant improvement in bulimic symptoms as well as all measures of outcome, and no statistically significant differences were observed between the two conditions at end of treatment or follow-up. Intent-to-treat abstinence rates for ICAT (37.5% at end of treatment, 32.5% at follow-up) and CBT-E (22.5% at both end of treatment and follow-up) were not significantly different. Conclusions ICAT was associated with significant improvements in bulimic and associated symptoms that did not differ from those obtained with CBT-E. This initial randomized controlled trial of a new individual psychotherapy for bulimia nervosa suggests that targeting emotion and self-oriented cognition in the context of nutritional rehabilitation may be efficacious and worthy of further study. PMID:23701891

  11. Comparison of the analgesic effects of dexketoprofen and diclofenac during shockwave lithotripsy: a randomized, double-blind clinical trial.

    Science.gov (United States)

    Tokgoz, Husnu; Yurtlu, Serhan; Hanci, Volkan; Turksoy, Ozlem; Erol, Bulent; Akduman, Bulent; Mungan, Aydin

    2010-06-01

    This prospective, randomized, and double-blind clinical study aimed to assess the analgesic efficacy of single-dose intramuscular (IM) injection of dexketoprofen (group DE) compared with single-dose IM injection of diclofenac (group DI) in patients who were undergoing shockwave lithotripsy (SWL). A total of 70 men with single renal or ureteral stones were randomly separated into two groups. The 40 men in group DI received 75 mg IM diclofenac sodium and 30 men in Group DE received 50 mg IM dexketoprofen trometamol 30 minutes before SWL. A 10-point visual analog scale was used to evaluate pain. The age, body mass index, and mean stone burden were comparable between the two groups (P > 0.05). The mean visual analog scale score for group DE was statistically lower compared with the score for group DI (P = 0.02). In 34 (85%) of the 40 men in group DI, the SWL procedure was performed with no, minor, or tolerable pain. In group DE, however, 28 (93.3%) of 30 patients evaluated the pain severity as no, minor, or tolerable (p = 0.01). No major/minor adverse effects were observed in group DI, whereas in one patient in group DE, dyspepsia after injection was noticed (P = 0.423). The severity of SWL-related pain was significantly better tolerated with dexketoprofen trometamol. During an SWL procedure, the analgesic efficacy of dexketoprofen was greater than that of diclofenac sodium. Although statistically insignificant, a little increased risk for gastric irritation was noticed with dexketoprofen.

  12. Comparison consequences of Jackson-Pratt drain versus chest tube after coronary artery bypass grafting: A randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Mohsen Mirmohammad-Sadeghi

    2017-01-01

    Full Text Available Background: Chest tubes are used in every case of coronary artery bypass grafting (CABG to evacuate shed blood from around the heart and lungs. This study was designed to assess the effective of Jackson-Pratt drain in compare with conventional chest drains after CABG. Materials and Methods: This was a randomized controlled trial that conducted on 218 patients in Chamran hospital from February to December 2016. Eligible patients were randomized in a 1:1 ratio. Jackson-Pratt drain group had 109 patients who received a chest tube insertion in the pleural space of the left lung and a Jackson-Pratt drain in mediastinum, and Chest tube drainage group had 109 patients who received double chest tube insertion in the pleural space of the left lung and the mediastinum. Results: The incidence of pleural effusions in Jackson-Pratt drain group and chest tube group were not statistically different. The pain score at 2-h in Drain group was significantly higher than chest tube group (P = 0.001, but the trend of pain score between groups was not significantly different (P = 0.097. The frequency of tamponade and atrial fibrillation (AF were significantly lower in Jackson-Pratt drain group (P < 0.05. Conclusion: The Jackson-Pratt drain is equally effective for preventing cardiac tamponade, pleural effusions, and pain intensity in patients after CABG when compared with conventional chest tubes, but was significantly superior regarding efficacy to hospital and Intensive Care Unit length of stay and the incidence of AF.

  13. Comparison of maternal and fetal outcomes among patients undergoing cesarean section under general and spinal anesthesia: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Anıl İçel Saygı

    Full Text Available CONTEXT AND OBJECTIVE: As the rates of cesarean births have increased, the type of cesarean anesthesia has gained importance. Here, we aimed to compare the effects of general and spinal anesthesia on maternal and fetal outcomes in term singleton cases undergoing elective cesarean section.DESIGN AND SETTING: Prospective randomized controlled clinical trial in a tertiary-level public hospital.METHODS: Our study was conducted on 100 patients who underwent cesarean section due to elective indications. The patients were randomly divided into general anesthesia (n = 50 and spinal anesthesia (n = 50 groups. The maternal pre and postoperative hematological results, intra and postoperative hemodynamic parameters and perinatal results were compared between the groups.RESULTS: Mean bowel sounds (P = 0.036 and gas discharge time (P = 0.049 were significantly greater and 24th hour hemoglobin difference values (P = 0.001 were higher in the general anesthesia group. The mean hematocrit and hemoglobin values at the 24th hour (P = 0.004 and P < 0.001, respectively, urine volume at the first postoperative hour (P < 0.001 and median Apgar score at the first minute (P < 0.0005 were significantly higher, and the time that elapsed until the first requirement for analgesia was significantly longer (P = 0.042, in the spinal anesthesia group.CONCLUSION: In elective cases, spinal anesthesia is superior to general anesthesia in terms of postoperative comfort. In pregnancies with a risk of fetal distress, it would be appropriate to prefer spinal anesthesia by taking the first minute Apgar score into account.

  14. Comparison of del Nido and St Thomas Cardioplegia Solutions in Pediatric Patients: A Prospective Randomized Clinical Trial.

    Science.gov (United States)

    Talwar, Sachin; Bhoje, Amolkumar; Sreenivas, Vishnubhatla; Makhija, Neeti; Aarav, Sudheer; Choudhary, Shiv Kumar; Airan, Balram

    2017-01-01

    We conducted a prospective randomized trial to compare del Nido (DN) cardioplegia with conventional cold blood cardioplegia (St Thomas [STH]) in pediatric patients. We randomized 100 pediatric patients aged ≤12 years undergoing elective repair of ventricular septal defects and tetralogy of Fallot to the DN and the STH groups. In the DN group, a 20 mL/kg single dose was administered. In the STH group, a 30 mL/kg dose was administered, followed by repeated doses at 25- to 30-minute intervals. The primary outcome was cardiac index that was measured 4 times intra- and postoperatively. Troponin-I, interleukin-6, and tissue necrosis factor-alpha were measured. Myocardial biopsy was obtained to assess electron-microscopic ultrastructural changes. Cardiac indices were significantly higher in the DN group than in the STH group 2 hours after termination of cardiopulmonary bypass (P = 0.0006), after 6 hours (P = 0.0006), and after 24 hours (P ≤ 0.0001). On repeated measure regression analysis, the cardiac index was on an average 0.50 L/min/m 2 higher in the DN group than in the STH group at any time point (P = 0.002). Duration of mechanical ventilation (P = 0.01), intensive care unit stay (P = 0.01), and hospital stay (P = 0.0007) was significantly lower in the DN group. Patients in the DN group exhibited lower troponin-I release 24 hours following cardiopulmonary bypass (P = 0.021). Electron microscopic studies showed more myofibrillar disarray in the STH group (P = 0.02). Use of long-acting DN cardioplegia solution was associated with better preservation of cardiac index, lesser troponin-I release, and decreased morbidity. Ultrastructural changes showed better preservation of myofibrillar architecture. Copyright © 2017 Elsevier Inc. All rights reserved.

  15. Assessing the Accuracy of Generalized Inferences From Comparison Group Studies Using a Within-Study Comparison Approach: The Methodology.

    Science.gov (United States)

    Jaciw, Andrew P

    2016-06-01

    Various studies have examined bias in impact estimates from comparison group studies (CGSs) of job training programs, and in education, where results are benchmarked against experimental results. Such within-study comparison (WSC) approaches investigate levels of bias in CGS-based impact estimates, as well as the success of various design and analytic strategies for reducing bias. This article reviews past literature and summarizes conditions under which CGSs replicate experimental benchmark results. It extends the framework to, and develops the methodology for, situations where results from CGSs are generalized to untreated inference populations. Past research is summarized; methods are developed to examine bias in program impact estimates based on cross-site comparisons in a multisite trial that are evaluated against site-specific experimental benchmarks. Students in Grades K-3 in 79 schools in Tennessee; students in Grades 4-8 in 82 schools in Alabama. Grades K-3 Stanford Achievement Test (SAT) in reading and math scores; Grades 4-8 SAT10 reading scores. Past studies show that bias in CGS-based estimates can be limited through strong design, with local matching, and appropriate analysis involving pretest covariates and variables that represent selection processes. Extension of the methodology to investigate accuracy of generalized estimates from CGSs shows bias from confounders and effect moderators. CGS results, when extrapolated to untreated inference populations, may be biased due to variation in outcomes and impact. Accounting for effects of confounders or moderators may reduce bias. © The Author(s) 2016.

  16. Localization in random bipartite graphs: Numerical and empirical study

    Science.gov (United States)

    Slanina, František

    2017-05-01

    We investigate adjacency matrices of bipartite graphs with a power-law degree distribution. Motivation for this study is twofold: first, vibrational states in granular matter and jammed sphere packings; second, graphs encoding social interaction, especially electronic commerce. We establish the position of the mobility edge and show that it strongly depends on the power in the degree distribution and on the ratio of the sizes of the two parts of the bipartite graph. At the jamming threshold, where the two parts have the same size, localization vanishes. We found that the multifractal spectrum is nontrivial in the delocalized phase, but still near the mobility edge. We also study an empirical bipartite graph, namely, the Amazon reviewer-item network. We found that in this specific graph the mobility edge disappears, and we draw a conclusion from this fact regarding earlier empirical studies of the Amazon network.

  17. Pediatric Basic Life Support Self-training is Comparable to Instructor-led Training: A randomized manikin study

    DEFF Research Database (Denmark)

    Vestergaard, L. D.; Løfgren, Bo; Jessen, C.

    2011-01-01

    Pediatric Basic Life Support Self-training is comparable to Instructor-led Training: A randomized manikin study.......Pediatric Basic Life Support Self-training is comparable to Instructor-led Training: A randomized manikin study....

  18. Comparison of a quantum random number generator with pseudorandom number generators for their use in molecular Monte Carlo simulations.

    Science.gov (United States)

    Ghersi, Dario; Parakh, Abhishek; Mezei, Mihaly

    2017-12-05

    Four pseudorandom number generators were compared with a physical, quantum-based random number generator using the NIST suite of statistical tests, which only the quantum-based random number generator could successfully pass. We then measured the effect of the five random number generators on various calculated properties in different Markov-chain Monte Carlo simulations. Two types of systems were tested: conformational sampling of a small molecule in aqueous solution and liquid methanol under constant temperature and pressure. The results show that poor quality pseudorandom number generators produce results that deviate significantly from those obtained with the quantum-based random number generator, particularly in the case of the small molecule in aqueous solution setup. In contrast, the widely used Mersenne Twister pseudorandom generator and a 64-bit Linear Congruential Generator with a scrambler produce results that are statistically indistinguishable from those obtained with the quantum-based random number generator. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

  19. A Prospective, Randomized Study Comparing 7-day and 14-day ...

    African Journals Online (AJOL)

    2018-02-07

    Feb 7, 2018 ... and 14-day quadruple therapies as first-line treatments for Helicobacter pylori infection in ..... Furthermore, in a large-scale, multicenter, Japanese study ... Taylor DE, Ge Z, Purych D, Lo T, Hiratsuka K. Cloning and sequence ...

  20. Localization of optical excitations on random surfaces: SNOM studies

    DEFF Research Database (Denmark)

    Bozhevolnyi, Sergey I.

    1999-01-01

    Localization of optical excitations on nanostructured metal surfaces and fractal colloid silver aggregates are studied by using a scanning near-field optical microscope (SNOM). The SNOM images obtained in both configurations exhibit spatially localized (within 150 to 250 nm) light intensity...