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Sample records for trial comparing transobturator

  1. Prospective and randomized clinical trial comparing transobturator versus retropubic sling in terms of efficacy and safety.

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    Palos, Claudia Cristina; Maturana, Ana P; Ghersel, Frederico R; Fernandes, Cesar E; Oliveira, Emerson

    2018-01-01

    The midurethral sling is the most commonly performed surgical procedure for stress urinary incontinence (SUI). We compared the efficacy of transobturator tape (TOT) and retropubic (RP) slings by evaluating objective and subjective cure rates at 12 months postsurgery and evaluate the impact on quality of life (QoL) and record intra- and postoperative complications. This was a randomized, controlled, prospective, clinical trial with analysis of noninferiority. The hypothesis was that the TOT sling is not inferior to the RP sling. A total of 92 women with SUI were selected and randomized into two groups: TOT and RP slings. Eighty-one patients maintained follow-up 12 months postoperatively. In the per-protocol analysis, the objective cure rates were 100% for the RP sling and 93% for the TOT sling (p = 0.029). The subjective cure rates were 92% for the RP sling and 90% for the TOT sling (p = 0.02). Because none of the upper limits of the confidence interval (CI) were above the noninferiority margin, noninferiority of the TOT sling could be concluded. In contrast, the intention-to-treat analysis could not show that the TOT sling was not inferior to the RP sling, because the upper limit of the CI surpassed the noninferiority margin. Postoperative complications were similar for both groups, except for higher urinary retention rates in the RP group. Regarding QoL, there was a significant improvement. The cure rates of the per-protocol analysis showed the noninferiority of the TOT relative to the RP sling. The RP sling group exhibited higher urinary retention. Quality of life improved significantly in both groups.

  2. A randomized, controlled trial comparing an innovative single incision sling with an established transobturator sling to treat female stress urinary incontinence

    NARCIS (Netherlands)

    Hinoul, Piet; Vervest, Harry A. M.; den Boon, Jan; Venema, Pieter L.; Lakeman, Marielle M.; Milani, Alfredo L.; Roovers, Jan-Paul W. R.

    2011-01-01

    Mid urethral sling procedures have become the surgical treatment of choice for female stress urinary incontinence. Innovative modifications of mid urethral sling procedures were recently introduced with the claim of offering similar efficacy and decreased morbidity. We compared the efficacy and

  3. Transobturator TVT-O versus retropubic TVT: results of a multicenter randomized controlled trial at 24 months follow-up.

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    Deffieux, Xavier; Daher, Nagib; Mansoor, Aslam; Debodinance, Philippe; Muhlstein, Joël; Fernandez, Hervé

    2010-11-01

    The purpose of this study is to compare the retropubic tension-free vaginal tape (TVT) procedure with the inside-out transobturator approach (TVT-O). Multicenter randomized controlled trial. One hundred forty-nine patients were randomly allocated to either TVT (n = 75) or TVT-O (n = 74). Interview, medical examination, pain scores, success rates, and quality of life assessment were recorded pre-operatively, and 2, 6, 12, and 24 months post-operatively. One hundred forty-nine patients underwent surgery, and 132 completed a 24-month follow-up. Bladder injury rate was 5% (4/75) in the TVT group and 2% (2/74) in the TVT-O group (p = 0.68). There was no significant difference between the two groups, concerning overall cure rate and the patients' satisfaction rate at 24 months follow-up. The range of mean pain scores was significantly higher after the TVT-O procedure post-operatively but not at 24 months follow-up. TVT and TVT-O procedures both have an outcome associated with an increase in quality of life with no significant differences in satisfaction rates at 2 years follow-up.

  4. Retropubic versus transobturator tension-free vaginal tape (TVT vs TVT-O): Five-year results of the Austrian randomized trial.

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    Tammaa, Ayman; Aigmüller, Thomas; Hanzal, Engelbert; Umek, Wolfgang; Kropshofer, Stephan; Lang, Peter F J; Ralph, George; Riss, Paul; Koelle, Dieter; Jundt, Katharina; Tamussino, Karl; Bjelic-Radisic, Vesna

    2018-01-01

    To compare outcomes of the retropubic versus the transobturator tension-free vaginal tape (TVT vs TVT-O) at 5 years. A total of 569 women undergoing surgery for primary stress incontinence were randomized to receive a retropubic or a transobturator tensionfree vaginal tape (TVT or TVT-O). Follow-up at 5 years included clinical examination, urodynamic studies and quality of life. The primary outcome measure was continence defined as a negative cough stress test at a volume of 300 mL. Secondary outcomes included urodynamic parameters, complications and quality of life.ClinicalTrials.gov (NCT 0041454). Three hundred and thirty-one patients (59%) were evaluated at 5 years (277 were seen, examined and completed questionnaires; 54 only completed questionnaires). No significant differences were seen in rates of a negative cough stress test (83% vs 76%, respectively), urodynamic parameters and complications. Quality-of-life improved significantly in both groups, without significant differences between the groups. Erosion rates were 5.2% and 4.5%, and reoperation rates were 4.1% and 3.2% respectively. At 5 years, subjective and objective results after TVT and TVT-O are stable and similar, without statistical significant differences between the procedures. Major long-term problems appear rare. © 2017 Wiley Periodicals, Inc.

  5. Contasure-Needleless® single incision sling compared with transobturator TVT-O® for the treatment of stress urinary incontinence: long-term results.

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    Martinez Franco, Eva; Amat Tardiu, Lluís

    2015-02-01

    This study compared transobturator tension-free vaginal tape (TVT-O®) and Contasure-Needleless (C-NDL®) at long-term follow-up . Non-inferiority, prospective, single-centre , quasi-randomised trial started in September 2006 and finished in April 2011 to compare C-NDL® with transobturator vaginal tape (TVT-O®) mesh in the treatment of stress urinary incontinence (SUI) . Epidemiological information, intraoperative and postoperative complications, subjective estimates of blood loss and pain levels were recorded. We also analysed the postoperative stress test, the subjective impression of improvement using the Sandvik Severity Index and the quality of life during follow-up using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) . Two hundred and fifty-seven women with primary SUI were scheduled to receive TVT-O® or C-NDL® and were followed up at least 3 years after the procedure . One hundred and eleven women in the C-NDL® group (84.7%) had a negative stress test, compared with 54 women (88.9%) in the TVT-O® group (p = 0.0065 for the non-inferiority test). The postoperative Sandvik Severity Index was 0 or better than the preoperative score in 90.7% of patients in the C-NDL® group and 95.4% of patients in the TVT-O® group (p = 0.0022). The complication rate was similar in both groups. There were significant differences (p = 0.02) in postoperative pain within the TVT-O® group. The degree of satisfaction was not statistically significant between the two groups. The outcomes for the C-NDL® group were similar to those of the TVT-O® group, adding the concept of "single incision tape" to the tension-free sling option.

  6. Vaginal mesh repair SYSTEMS for pelvic organ prolapse: Anatomical study comparing transobturator/trangluteal versus single incision techniques.

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    Campagna, Giuseppe; Panico, Giovanni; Morciano, Andrea; Gadonneix, Pierre; Delmas, Vincent; Cervigni, Mauro; Ercoli, Alfredo; Scambia, Giovanni

    2017-09-18

    The present study aim to compare the anatomic landmarks of two pelvic floor repair systems, in order to identify the potential neurovascular lesions related to different mesh fixation techniques. Abdominal and perineal dissections of 10 fresh cadavers after prolapse surgery using transobturator/transgluteal versus single incision techniques. Neuro-vascular structures of obturator region and perineum were isolated. Distances between needles and anatomical structures were measured. During transobturator anterior repair, the superficial cannula passed 2.5 ± 0.6 cm medially to the obturator canal. The distance of superficial arm to the anterior obturator vessels was 2.2 ± 0.4 cm. The distance of deep cannula to the posterior obturator vessels branches was 1.3 ± 0.5 cm. In two of these cases we observed a lesion of posterior obturator vessels. During single incision repair the distance between the obturator canal and the superficial arms was 2.3 ± 0.7. The mean distances of superficial arms to the anterior and posterior obturator vessels were, respectively, 2.3 ± 0.5 cm and 3.2 ± 0.7 cm. During transgluteal posterior repair the distance between the cannula guide and the ischial spine was 1.7 ± 0.5 cm while it measured 2.3 ± 0.4 cm when single incision posterior device was placed. Anterior transobturator system presents an increased risk of posterior obturator vessels branches injury. During posterior transgluteal repair the distance of the ischio-anal fossa to sacrospinous ligament represents a way that could rule against the correct needle positioning with increased risk of pudendal lesions. Single incision approach offers an easier access to the sacrospinous ligament with lower risk of pudendal lesions. © 2017 Wiley Periodicals, Inc.

  7. Incontinence surgery in obese women: comparative analysis of short- and long-term outcomes with a transobturator sling.

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    Pereira, Inês; Valentim-Lourenço, Alexandre; Castro, Catarina; Martins, Inês; Henriques, Alexandra; Ribeirinho, Ana Luísa

    2016-02-01

    Midurethral slings (MUS) are still discussed in complex incontinence situations, such as obesity, lacking sustained efficacy validation in this particular sub-population. We hypothesized that the outcomes of a transobturator MUS, such as TVT-O, do not differ according to body mass index (BMI) over a 4-year period. We conducted a retrospective analysis of 281 women who underwent TVT-O at our institution, between 2004 and 2012. Patients were stratified into obese (BMI ≥ 30 kg/m(2)) or non-obese (BMI < 30 kg/m(2)). We compared preoperative and postoperative parameters, including objective cure (negative stress test), complications, and quality of life scores. Data were collected at 0, 6, 12, 24, and 48 months. We used Fisher's exact test for categorical variables and Student's t test or the Mann-Whitney U test for continuous variables. Baseline characteristics of the obese (n = 122) and non-obese groups (n = 159) were similar. We found no significant differences between groups in terms of objective cure rates at all follow-up evaluations, with 95.8 % and 95 % at 48 months in the non-obese and obese groups respectively. There were no significant differences in the cumulative complication rates of both groups. Quality of life assessment also showed no significant differences between groups at all follow-up visits. At 48 months our follow-up rate was 59 % (n = 96) and 60.4 % (n = 72) in the non-obese and obese group respectively (p = 0.9). The TVT-O procedure is effective and safe in the long term for stress incontinence treatment, regardless of BMI.

  8. Tension-Free Vaginal Tape, Transobturator Tape, and Own Modification of Transobturator Tape in the Treatment of Female Stress Urinary Incontinence: Comparative Analysis

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    Marcin Zyczkowski

    2014-01-01

    Full Text Available Introduction. This study is a comparative evaluation of the TVT, TOT, and our own modification of TOT (mTOT in the treatment of female stress urinary incontinence from a single center experience. Material and Methods. The study was conducted on 527 patients with SUI diagnosed on the basis of urodynamic studies. They were divided into three groups—TVT: n=142, (TOT: n=129, and mTOT: n=256. All of the patients underwent evaluation at 1, 3, and 6 months after surgery. Results were statistically analysed and compared. Results. Objective and subjective effectiveness after the surgery were not significantly different in the study groups and ranged from 90.1% to 96.4%. Mean surgery time was 32.3, 28.2, and 26.4 in the TVT, TOT, and mTOT, respectively. Mean hospitalization time was 2.51 days. Mean catheter maintenance time was significantly higher in the TVT than in other groups. In the TVT group total incidence of complications was 13.4%, and it was significantly higher than that in TOT and mTOT (9.3% and 8.6%, resp.. Conclusions. TVT, TOT, and mTOT are highly effective and safe methods in the treatment of SUI. There are no differences in the efficacy between the methods with a little higher percentage of complications in the TVT group.

  9. Contasure-Needleless compared with transobturator-TVT for the treatment of stress urinary incontinence.

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    Amat I Tardiu, Lluís; Martínez Franco, Eva; Laïlla Vicens, Josep Maria

    2011-07-01

    Single-incision devices for the treatment of stress urinary incontinence (SUI) have been introduced in the last few years. We report a comparison between Obturator Tension-free vaginal tape (TVT-O) and Contasure-Needleless (C-NDL). One hundred and fifty-eight women with primary SUI were scheduled to receive TVT-O or C-NDL and follow-up during the first year. Epidemiological information, complications, blood loss, and pain level were recorded. We also analyze stress test and quality of life. Sixty-three (87.5%) C-NDL presented a negative stress test, compared with 54 (90%) of TVT-O (p value 0.015 for non-inferiority test). Sandvik Severity Index was 0 in 75.4% in the C-NDL group and 87.3% in the TVT-O (p TVT-O group. C-NDL provides similar outcomes as TVT-O after 1-year follow-up. It is necessary that long-term data confirm our results.

  10. Comparing effectiveness of combined transobturator tension-free vaginal mesh (Perigee) and transobturator tension-free vaginal tape (TVT-O) versus anterior colporrhaphy and TVT-O for associated cystocele and urodynamic stress incontinence.

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    Lau, Hei-Yu; Twu, Nae-Fang; Chen, Yi-Jen; Horng, Huann-Cheng; Juang, Chi-Mou; Chao, Kuan-Chong

    2011-06-01

    To evaluate the efficacy and safety of transobturator tension-free vaginal mesh (Perigee) and concomitant transobturator tension-free vaginal tape (TVT-O) for treating cystocele with urodynamic stress incontinence (UDSI). A retrospective study of 115 patients with symptomatic stages 2-3 cystocele and UDSI who were treated with a Perigee system (Group I, n=68) plus TVT-O procedure or traditional anterior colporrhaphy (Group II, n=47) plus TVT-O procedure. All patients were followed up for more than one year. Objective and subjective symptoms were evaluated at one year postoperatively. Statistical analysis was performed using SPSS software. The objective cure rates for cystocele at one year were significantly higher in Group I than in Group II (98.5% and 86.9%, P=0.018), respectively. The cure rates for UDSI in the two groups were 91.0% vs. 91.3% (P=1.000). Symptomatic improvement of frequency was better in Group I than Group II (87.7% vs. 70.0%, P=0.030). There were no significant differences with regard to intraoperative and postoperative complications between the two groups. The combination of the Perigee system and TVT-O offers a safe and effective treatment for cystocele with UDSI and may be performed as first-line treatment. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  11. Transobturator vaginal tape in comparison to tension-free vaginal tape: A prospective trial with a minimum 12 months follow-up

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    R B Nerli

    2009-01-01

    Full Text Available Background: The tension-free vaginal tape (TVT procedure is based on the integral theory that the midurethra has an important role in the continence mechanism. Transobturator vaginal tape (TOT is the same in concept as TVT but it differs from TVT in that, rather than passing through the retropubic space, sling materials are drawn through the obturator foramina. We prospectively compared TVT with TOT with respect to operation-related morbidity and surgical outcomes at a minimum follow up of 12 months. Materials and Methods: A total of 36 women with stress urinary incontinence (SUI were alternatively assigned to the TVT group (18 or the TOT group. Preoperative evaluation included urodynamic study and I-QOL questionnaire. One year after operation the surgical result, patient satisfaction, incontinence quality-of-life questionnaire, long-term complications, and uroflowmetry were evaluated in both groups. Results: The patient characteristics in both the TVT and TOT group were similar. Mean operating time was significantly shorter in the TOT group likened to the TVT group. Conclusions: Both the TVT and TOT procedures are minimally invasive and similar in operation-related morbidity. TOT appears to be as effective as TVT, and safer than TVT for the surgical treatment of SUI in women at 12 months follow-up.

  12. Surgical management of stress urinary incontinence in women: safety, effectiveness and cost-utility of trans-obturator tape (TOT) versus tension-free vaginal tape (TVT) five years after a randomized surgical trial

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    2011-01-01

    Background We recently completed a randomized clinical trial of two minimally invasive surgical procedures for stress urinary incontinence, the retropubic tension-free vaginal tape (TVT) versus the trans-obturator tape (TOT) procedure. At one year postoperatively, we were concerned to find that a significant number of women had tape that was palpable when a vaginal examination was undertaken. Because the risk factors for adverse outcomes of tape surgery are not clearly understood, we are unable to say whether palpable tapes will lead to vaginal erosions or whether they merge into vaginal tissue. We do not know whether patients go on to have further adverse consequences of surgery, leading to additional cost to patients and healthcare system. Our current study is a 5 year follow-up of the women who took part in our original trial. Methods/Design All 199 women who participated in our original trial will be contacted and invited to take part in the follow-up study. Consenting women will attend a clinic visit where they will have a physical examination to identify vaginal erosion or other serious adverse outcomes of surgery, undertake a standardized pad test for urinary incontinence, and complete several health-related quality of life questionnaires (15D, UDI-6, IIQ-7). Analyses will compare the outcomes for women in the TOT versus TVT groups. The cost-effectiveness of TOT versus TVT over the 5 years after surgery, will be assessed with the use of disease-specific health service administrative data and an objective health outcome measure. A cost-utility analysis may also be undertaken, based on economic modeling, data from the clinical trial and inputs obtained from published literature. Discussion This study is needed now, because TOT and TVT are among the most frequently conducted surgical procedures for stress urinary incontinence in Canada. Because stress urinary incontinence is so common, the impact of selecting an approach that causes more adverse events, or is

  13. Surgical management of stress urinary incontinence in women: safety, effectiveness and cost-utility of trans-obturator tape (TOT versus tension-free vaginal tape (TVT five years after a randomized surgical trial

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    Eliasziw Misha

    2011-07-01

    Full Text Available Abstract Background We recently completed a randomized clinical trial of two minimally invasive surgical procedures for stress urinary incontinence, the retropubic tension-free vaginal tape (TVT versus the trans-obturator tape (TOT procedure. At one year postoperatively, we were concerned to find that a significant number of women had tape that was palpable when a vaginal examination was undertaken. Because the risk factors for adverse outcomes of tape surgery are not clearly understood, we are unable to say whether palpable tapes will lead to vaginal erosions or whether they merge into vaginal tissue. We do not know whether patients go on to have further adverse consequences of surgery, leading to additional cost to patients and healthcare system. Our current study is a 5 year follow-up of the women who took part in our original trial. Methods/Design All 199 women who participated in our original trial will be contacted and invited to take part in the follow-up study. Consenting women will attend a clinic visit where they will have a physical examination to identify vaginal erosion or other serious adverse outcomes of surgery, undertake a standardized pad test for urinary incontinence, and complete several health-related quality of life questionnaires (15D, UDI-6, IIQ-7. Analyses will compare the outcomes for women in the TOT versus TVT groups. The cost-effectiveness of TOT versus TVT over the 5 years after surgery, will be assessed with the use of disease-specific health service administrative data and an objective health outcome measure. A cost-utility analysis may also be undertaken, based on economic modeling, data from the clinical trial and inputs obtained from published literature. Discussion This study is needed now, because TOT and TVT are among the most frequently conducted surgical procedures for stress urinary incontinence in Canada. Because stress urinary incontinence is so common, the impact of selecting an approach that causes

  14. Predictive factors that influence treatment outcomes of innovative single incision sling: comparing TVT-Secur to an established transobturator sling for female stress urinary incontinence.

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    Hwang, Eugene; Shin, Ju Hyun; Lim, Jae Sung; Song, Ki Hak; Sul, Chong Koo; Na, Yong Gil

    2012-07-01

    This study aims to identify independent risk factors for treatment failure of tension-free vaginal tape TVT-Secur (TVT-S) compared to that of the well-established transobturator tape. Of a total of 175 consecutive patients with urodynamically confirmed stress urinary incontinence (SUI) identified between July 2007 and March 2010, 89 patients underwent TVT-S, and 86 underwent TOT. Cure was defined using the Urogenital Distress Inventory as no urinary leakage during physical activity, coughing, or sneezing as reported by patients during a telephone survey. To identify predictors of treatment failure, multivariable logistic regression models were used, and odds ratios (ORs) were calculated using variables identified during univariate analysis. There were more patients with cystocele ≥ grade 2 in the TVT-S group (p = 0.031); otherwise the groups were well matched. After a median follow-up of 32 months (range, 12-44 months), the overall cure rate was 80.6%; it was 70.8% for those treated with TVT-S and 90.7% for those treated with TOT (p = 0.001). In a multivariate model, previous incontinence surgery (OR 27.1, p = 0.005) and a cystocele ≥ grade 2 (OR 3.0, p = 0.020) were independent risk factors influencing the outcome of TVT-S procedures. For the TOT procedures, detrusor overactivity was an independent risk factor in a multivariate model (OR 8.6, p = 0.033). TVT-S could be performed for selected patients, but conventional TOT procedures are still superior to the novel TVT-S device.

  15. Tension-Free Vaginal Tape versus Transobturator Tape for ...

    African Journals Online (AJOL)

    Objectives: The transobturator tape (TOT) is based on a similar principle as the tension-free vaginal tape (TVT), but introduced through the obturator foramen. The aim of this study was to compare these slings as surgical procedures for the treatment of stress urinary incontinence (SUI) in women. Patients and Methods: This ...

  16. Preoperative Valsava leak point pressure may not predict outcome of mid-urethral slings: analysis from a randomized controlled trial of retropubic versus transobturator mid-urethral slings

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    Elisabetta Costantini

    2008-02-01

    Full Text Available OBJECTIVE: To test the hypothesis that preoperative Valsalva leak point pressure (VLPP predicts long-term outcome of mid-urethra slings for female stress urinary incontinence (SUI. MATERIALS AND METHODS: One hundred and forty-five patients with SUI were prospectively randomized to two mid-urethra sling treatments: Tension free vaginal tape (TVT or transobturator tape (TOT. They were followed-up at 3, 6, 12 months post-operatively and then annually for the primary outcome variable, i.e. dry or wet and secondary outcome variables such as scores on the urogenital distress inventory (UDI-6 and the impact of incontinence on quality of life (IIQ-7 questionnaire as well as patient satisfaction as scored on a visual analogue scale (VAS. Preoperative VLPP was correlated with primary and secondary outcome variables. RESULTS: Mean follow-ups were 32 + 12 months (range 12-55 for TVT and 31 + 15 months (range 12-61 for TOT. When patients were analyzed according to VLPP stratification, 95 (65.5% patients showed a VLPP > 60 cm H2O and 50 (34.5% patients had a VLPP 60 cm H2O and 72% for those with VLPP 60 cm H2O (82 % vs. 68.9% p of 60 cm H2O, preoperative VLPP was not linked to outcome after TVT or TOT procedures.

  17. Efficacy of tension-free vaginal tape compared with transobturator tape in the treatment of stress urinary incontinence in women: analysis of learning curve, perioperative changes of voiding function

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    2011-01-01

    Background In this study, by comparing TVT surgery and TOT surgery for stress urinary incontinence in women, the characteristics and learning curves of both operative methods were studied. Methods A total of 83 women with stress urinary incontinence treated with tension-free vaginal tape (TVT) (n = 38) or transobturator tape (TOT) (n = 45) at Saiseikai Central Hospital between April 2004 and September 2009 were included. We compare the outcomes and learning curves between TVT surgery and TOT surgery. In statistical analysis, Student's t test, Fisher's exact test, and Mann-Whitney's U test were used. Results The surgical durations were 37.4 ± 15.7 minutes with TVT surgery and 31.0 ± 8.3 minutes with TOT surgery. A longer period of time was required for TVT surgery (p = 0.025). The residual urine at post-operative day 1 was higher in TVT surgery (25.9 ± 44.2 ml) than in TOT surgery (10.6 ± 19.2 ml) (p = 0.0452). The surgical duration of TVT surgery was shortened after the operator had performed 15 operations (p = 0.019). Conclusions In comparison of TVT surgery and TOT surgery, the surgical duration of TVT surgery was longer and the residual urine of TVT surgery was higher at post-operative day 1. Surgical experience could shorten the duration of TVT surgery. PMID:21726448

  18. Efficacy of tension-free vaginal tape compared with transobturator tape in the treatment of stress urinary incontinence in women: analysis of learning curve, perioperative changes of voiding function

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    Kanai Kunimitsu

    2011-07-01

    Full Text Available Abstract Background In this study, by comparing TVT surgery and TOT surgery for stress urinary incontinence in women, the characteristics and learning curves of both operative methods were studied. Methods A total of 83 women with stress urinary incontinence treated with tension-free vaginal tape (TVT (n = 38 or transobturator tape (TOT (n = 45 at Saiseikai Central Hospital between April 2004 and September 2009 were included. We compare the outcomes and learning curves between TVT surgery and TOT surgery. In statistical analysis, Student's t test, Fisher's exact test, and Mann-Whitney's U test were used. Results The surgical durations were 37.4 ± 15.7 minutes with TVT surgery and 31.0 ± 8.3 minutes with TOT surgery. A longer period of time was required for TVT surgery (p = 0.025. The residual urine at post-operative day 1 was higher in TVT surgery (25.9 ± 44.2 ml than in TOT surgery (10.6 ± 19.2 ml (p = 0.0452. The surgical duration of TVT surgery was shortened after the operator had performed 15 operations (p = 0.019. Conclusions In comparison of TVT surgery and TOT surgery, the surgical duration of TVT surgery was longer and the residual urine of TVT surgery was higher at post-operative day 1. Surgical experience could shorten the duration of TVT surgery.

  19. Comparison of the clinical outcomes of transobturator and single-incision slings for stress urinary incontinence

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    Ling-Ying Wu

    2016-07-01

    Full Text Available The aim of this study was to compare the clinical outcomes of anti-incontinence surgeries employing the transobturator sling and single-incision sling (SIS. Our hypothesis is that the outcome of the SIS is not inferior to the obturator sling. This retrospective study reviewed the medical records of patients who underwent anti-incontinence surgery with the transobturator sling or SIS from July 2005 to November 2014. Patients who underwent concomitant pelvic organ reconstruction with an artificial mesh were excluded. Assessments included preoperative and postoperative urodynamic examinations, perioperative complications, and postoperative urogenital symptoms. A total of 122 women were recruited according to the inclusion and exclusion criteria. Among them, 68 patients underwent transobturator sling procedures while 54 patients underwent SIS procedures. The subjective failure rate of the transobturator sling and SIS were 10.2% and 18.5%, respectively (p = 0.292. The objective failure rate, defined as a pad test showing more than 2 g of urine, was 10.2% for the transobturator sling and 12.9% for the SIS (p = 0.777. SIS resulted in less blood loss, operative time, length of hospital stay, and transient voiding dysfunction after the operation. No major complication occurred after either surgical intervention. In conclusion, SIS and transobturator slings might have similar efficacy, safety, and effects on new-onset urogenital symptoms.

  20. Trans-obturator Tape in surgical treatment of urinary incontinence

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    Ashrafi M

    2008-06-01

    Full Text Available Background: The aim of this study was to assess the efficacy and safety of a new minimally-invasive surgical procedure using trans-obturator Tape (TOT to treat female stress urinary incontinence.Methods: This clinical trial study was performed from 2003 to 2004 in the Gynecology Department of Imam Hospital, Vali-e-Asr, Tehran, Iran. A total of 35 women with stress urinary incontinence underwent the TOT procedure. All patients underwent pre-operative clinical examination, cough-stress test (full bladder, uroflowmetry and post-voiding residual volume assessment. Results: The mean age of patients was 50 years, ranging from 26 to 74 years, with an average urinary stress incontinence duration of six years. The mean time of follow-up was 14 months (at 1, 6, 12 and 24 months and the average duration of surgery was about 20 minutes. The perioperative complication rate was 9% with no vascular, nerve or bowel injuries. The rate of hemorrhagic side effects (spontaneously-absorbed hematoma and blood loss not requiring blood transfusion was 2.9%. Post-operative urinary retention and vaginal erosion occurred in one case each; the former was treated by intermittent self-catheterization. In total, 91.4% of patients were completely cured and 8.6% were improved without failure of treatment. Conclusions: The present study confirms the results obtained by Delorme and coworkers, and allows us to consider TOT as a safe, minimally invasive and efficient short-term surgical technique for the treatment of female stress urinary incontinence, alone or in combination with prolapse repair. Following this study, a randomized control trial is recommended to compare TOT with the gold standard surgery for women with urinary incontinence.

  1. Efficacy and outcomes of transobturator tension-free vaginal tape with or without concomitant pelvic floor repair surgery for urinary stress incontinence: five-year follow-up.

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    Law, Tracy S M; Cheung, Rachel Y K; Chung, Tony K H; Chan, Symphorosa S C

    2015-08-01

    To compare the 5-year subjective and objective outcomes of transobturator tension-free vaginal tape alone versus the same procedure with concomitant pelvic floor repair surgery for pelvic organ prolapse in women with urinary stress incontinence. Prospective cohort study. Urogynaecology unit at a university hospital in Hong Kong. Of 218 women, 96 (44%) received transobturator tension-free vaginal tape alone and 122 (56%) received transobturator tension-free vaginal tape with concomitant pelvic floor repair surgery from September 2004 to December 2009. The women were followed up annually for up to 5 years after the operation. The 5-year subjective and objective cure rates were assessed. Subjective cure was defined as no urine loss during physical activity and objective cure was defined as no urine leakage on coughing during urodynamic study. Overall, 88 women receiving transobturator tension-free vaginal tape alone and 101 women receiving transobturator tension-free vaginal tape with concomitant pelvic floor repair surgery were followed up for 5 years after operation. The subjective and objective cure rates of the two groups were 70.5% versus 94.1% (Ppelvic floor repair surgery for pelvic organ prolapse, providing high subjective and objective efficacy for up to 5 years after operation. Transobturator tension-free vaginal tape with concomitant pelvic floor repair surgery achieved similar, if not better, long-term outcome compared with transobturator tension-free vaginal tape alone.

  2. Outcome and complications of retropubic and transobturator midurethral slings translated into surgical therapeutic indices

    NARCIS (Netherlands)

    Houwert, R. Marijn; Roovers, Jan Paul W. R.; Venema, Pieter L.; Bruinse, Hein W.; Dijkgraaf, Marcel G. W.; Vervest, Harry A. M.

    2010-01-01

    OBJECTIVE: We sought to determine and compare surgical therapeutic indices (STIs) of the retropubic tension-free vaginal tape (TVT) and 2 kinds of transobturator tape (TOT), Monarc (American Medical Systems, Minneapolis, MN), and tension-free vaginal tape obturator. STUDY DESIGN: This was a

  3. Comparison of Tension-free Vaginal Tape Versus Transobturator Tape in Women with Stress Urinary Incontinence

    Directory of Open Access Journals (Sweden)

    Zinat Ghanbari

    2007-06-01

    Full Text Available Objective: This study compared the Tension-free vaginal tape (TVT and Transobturator tape (TOT procedures for surgical treatment of stress urinary incontinence in women.Materials and methods: This prospective non randomized clinical trial was conducted in Vali-e-asr hospital from March 2001 to March 2005. A total of 71 patients with clinical and urodynamic diagnosis of Stress urinary incontinence (SUI were enrolled in the study. Patients were divided into two groups and underwent TVT or TOT procedures. Mean operation time, cure rate, post operative urinary retention, bleeding and infection were compared between two groups. SPSS software was used for statistical analysis. Chi square and fisher exact test calculated the effects of the nominal variables. Mean difference of quantitative variables were compared by student's T- test. P ≤0.05 was considered statistically significant. Results: There was no significant difference in mean time of operation and peri-operative complications among groups. Urinary retention was 13.8% (n=5 in the TVT group versus 2.8% (n=1 in TOT group (NS. The rates of cure (91.6% vs 91.4%, improvement (5.6% vs 8.6% and failure (2.8% vs 0 were similar for the TVT and TOT groups. The rate of hemorrhagic complications was 5.5% in TVT and 2.8% in TOT group (NS.Conclusion: TOT appears to be equally efficient to TVT for surgical treatment of stress urinary incontinence after 30 months follow-up.

  4. Transobturator Midurethral Slings versus Single-Incision Slings for Stress Incontinence in Overweight Patients

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    Omer Bayrak

    2015-08-01

    Full Text Available ABSTRACTPurpose:To compare transobturator midurethral sling (TOS and single-incision sling procedures in terms of their effects on urinary incontinence and the quality of life in overweight (BMI ≥25-29.9 kg/m2 female patients using the International Consultation on Incontinence Questionnaire scoring form (ICIQ-SF and Quality of Life of Persons with Urinary Incontinence scoring form (I-QOL.Materials and Methods:In this prospective trial, the patients were divided into two groups consecutively; first 20 overweight female patients underwent the TOS (Unitape T®,Promedon, Cordoba, Argentina procedure and the subsequent 20 consecutive overweight female patients underwent the single-incision sling [TVT-secur (Ethicon Inc., Sommerville, USA] procedure. Age, urinary incontinence period, parity and daily pads usage were recorded. No usage of pads was defined as subjective cure rate postoperatively. Before the operation and 6. month after the surgery, the patients completed the ICIQ-SF and I-QOL.Results:There was no significant difference between the two groups in terms of mean age, duration of incontinence, parity, and BMI (p>0.05. ICIQ-SF and I-QOL revealed that the patients in the TOS group showed significantly better improvement (76.20% versus 64.10%, p=0.001, 81.31% versus 69.28%, p=0.001, respectively. In addition, subjective cure rates were found higher in TOS group (75% versus 55%, p=0.190.Conclusions:The existing data is showed that incontinence symptoms and the quality of life have higher improvement in overweight female patients who underwent the TOS procedure. It is likely that the TOS procedure may provide stronger urethral support and better contributes to continence in this group of patients.

  5. Comparison of one-year results of transobturator tape method in the stress incontinence treatment according to body mass index.

    Science.gov (United States)

    Kumsar, Şükrü; Aydemir, Hüseyin; Köse, Osman; Budak, Salih; Sağlam, Hasan Salih; Adsan, Öztuğ

    2015-09-01

    The purpose of this study was to compare the 1-year results of patients on whom we used the transobturator tape method for the stress incontinence treatment according to body mass index (BMI). Patients diagnosed with stress incontinence and treated with the transobturator tape method were divided into three groups according to BMI. We recorded the results of preoperative urodynamic studies; durations of operation, catheterization, and hospitalization; and complications of patients. Patients were evaluated 1 year after the operation with respect to the objective/subjective success rates of the operation, patient satisfaction rates, and possible late complications. The obese group was observed to have a significantly higher duration of operation than the normal and overweight groups (pstress incontinence treatment has similar objective and subjective success rates, independent of BMI. In the obese patients, the operation time is longer than the others, but there is no difference with respect to the complication rates.

  6. Transobturator Tape (TOT) for treatment of female stress incontinence

    African Journals Online (AJOL)

    Objective: Evaluation of the transobturator tape (TOT), the newest tension-free technique for the treatment of female stress urinary incontinence (SUI) and its early results with 6 months follow up. Patients and Methods: This study was conducted at King Saud Hospital, Saudi Arabia, between September 2002 and March 2004 ...

  7. The long-term influence of body mass index on the success rate of mid-urethral sling surgery among women with stress urinary incontinence or stress-predominant mixed incontinence: comparisons between retropubic and transobturator approaches.

    Science.gov (United States)

    Jeong, Seong Jin; Lee, Han Sol; Lee, Jeong Keun; Jeong, Jin Woo; Lee, Sang Cheol; Kim, Jeong Hyun; Hong, Sung Kyu; Byun, Seok-Soo; Lee, Sang Eun

    2014-01-01

    Mid-urethral sling (MUS) surgery for the treatment of urinary incontinence has been widespread since the introduction of tension-free vaginal tape in the mid-1990s. The majority of studies with short-term follow-up body mass index (BMI). However, considering the chronic influence of obesity on pelvic floor musculature, it is cautiously speculated that higher BMI could increase stress on pelvic floor and sub-urethral tape, possibly decreasing the long-term success rate in the obese population. We aimed to compare the long-term effects of BMI on the outcomes of MUS between women with retropubic and transobturator approaches. We performed a retrospective analysis on 243 consecutive women who received MUS and were followed up for ≥36 months. The influence of BMI on the success rates was separately estimated and the factors for treatment failure were examined using logistic regression in either approach. The mean follow-up was 58.4 months, and 30.5% were normal weight, 51.0% overweight, and 18.5% obese. Patients received either the retropubic (30.5%) or transobturator (69.5%) approach. The success rates (%) under the transobturator approach differed according to the BMI groups (94.3, 88.6, and 78.6, respectively; P = 0.037) while those under the retropubic approach were not different according to the BMI groups. However, in multivariate models, only the presence of preoperative mixed urinary incontinence (MUI) was proven to be the risk factor for treatment failure in the transobturator approach (OR 6.39, P = 0.003). The percent of subjects with MUI was higher in obese women than in non-obese women with the transobturator approach. BMI was not independently associated with failures in either approach. Higher success rates in women with lower BMI in the transobturator approach were attributed to the lower percent of preoperative MUI in those with lower BMI.

  8. Simultaneous treatment of anterior vaginal wall prolapse and stress urinary incontinence by using transobturator four arms polypropylene mesh.

    Science.gov (United States)

    Sharifiaghdas, Farzaneh; Daneshpajooh, Azar; Mirzaei, Mahboubeh

    2015-12-01

    To evaluate the medium-term efficacy and safety of transobturator four-arm polypropylene mesh in the treatment of high-stage anterior vaginal wall prolapse and concomitant stress urinary incontinence (SUI). Between September 2010 and August 2013, a prospective single-center trial was performed to evaluate women with stage≥3 anterior vaginal wall prolapse with or without SUI who presented to Labbafinejad Hospital, Teheran, Iran, and underwent anterior vaginal wall repair with polypropylene mesh. Pre- and postoperative evaluation included history; physical examination using the Pelvic Organ Prolapse Quantification system and cough stress test, both before and after reduction of prolapsed structures; Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ); urinalysis and culture; and a postvoid residual assessment. Complications were reported at a mean of 2 years of follow-up. A total of 71 patients underwent cystocele repair with the transobturator four-arm polypropylene mesh. Seven of the patients were lost to follow-up. There were no perioperative complications. The anatomical success rate was 87.5%. The subjective success rate was 92.1%. The PFDI and PFIQ were significantly improved after surgery (ppolypropylene mesh is an effective device for simultaneous correction of anterior vaginal wall prolapse and SUI with a low complication rate at a medium-term follow-up. The majority of the subgroup with concomitant SUI were cured without a second simultaneous procedure.

  9. Transobturator tape for female stress incontinence: A day surgery case

    Directory of Open Access Journals (Sweden)

    Al Taweel Waleed

    2009-01-01

    Full Text Available Aim: To evaluate the effectiveness of transobturator vaginal tape (TOT in the treatment of female stress urinary incontinence (SUI and to analyze functional results and quality of life after12 months follow up. Materials and Methods : All women with SUI who underwent TOT procedure from outside to inside under general or regional anesthesia from December 2004 to January 2007 were included in the study. All must have had a minimal follow up of one year. The patients were prospectively evaluated with history including pads use/day, physical examination - pelvic examination, urinalysis, urogenital distress inventory (UDI-6, and analog global satisfaction scale - and urodynamic studies - filling cystometry, pressure-flow studies, and Valsalva leak point pressure. Results: Sixty two consecutive patients who fulfilled the inclusion criteria underwent TOT procedure by one surgeon. The mean age was 52 ± 9 years (range, 34-70 years and minimal follow up was one year (12-24 months. The mean operative time was 17 ± 4 minutes (15-31 with average amount of bleeding 62 ± 22 cc. We found objectively 89% cure or improvement rate after one year. Conclusion: The out-in transobturator approach is a very effective treatment of SUI with low morbidity and high success rate. However, longer follow up in larger populations should assess the long-term reliability of this attractive procedure.

  10. Peri-operative morbidity and early results of a randomised trial comparing TVT and TVT-O.

    Science.gov (United States)

    Meschia, Michele; Bertozzi, Rosanna; Pifarotti, Paola; Baccichet, Roberto; Bernasconi, Francesco; Guercio, Elso; Magatti, Fabio; Minini, Gianfranco

    2007-11-01

    The aim of this study was to compare the morbidity and short-term efficacy of retro-pubic (TVT) and inside-out trans-obturator (TVT-O) sub-urethral sling in the treatment of stress urinary incontinence. This was a prospective multi-centre randomised trial; 231 women with primary stress urinary incontinence were randomised to TVT (114) or TVT-O (117). The International Consultation on Incontinence-Short Form (ICIQ-SF), Women Irritative Prostate Symptoms Score (W-IPSS) and Patient Global Impression of Severity (PGI-S) questionnaires were used to evaluate the impact of incontinence and voiding dysfunction on QoL and to measure the patient's perception of incontinence severity. The primary and secondary outcome measures were rates of success and complications. The SPSS software was used for data analysis. The TVT-O procedure was associated with significantly shorter operation time and with a more extensive use of general anaesthesia when compared with TVT. There were 5 (4%) bladder perforations in the TVT group compared with none in the TVT-O group. Rates of early post-operative urinary retention and voiding difficulty were similar for both groups and no difference was found in the average hospital stay. Six patients (5%) in the TVT-O group complained of thigh pain in the post-operative course. The median follow-up time was 6 months. Two hundred eighteen patients were available for the analysis of outcomes. Subjective and objective cure rates were 92% and 92% in the TVT group and 87% and 89% in the TVT-O group. The ICIQ-SF questionnaire symptoms score showed a highly statistical decrease in both groups, the W-IPSS on the contrary was unchanged. Our data show that both procedures were equally effective in the short-term for the treatment of stress urinary incontinence with a highly significant improvement in incontinence-related QoL.

  11. The long-term influence of body mass index on the success rate of mid-urethral sling surgery among women with stress urinary incontinence or stress-predominant mixed incontinence: comparisons between retropubic and transobturator approaches.

    Directory of Open Access Journals (Sweden)

    Seong Jin Jeong

    Full Text Available Mid-urethral sling (MUS surgery for the treatment of urinary incontinence has been widespread since the introduction of tension-free vaginal tape in the mid-1990s. The majority of studies with short-term follow-up <2 years found no differences in the surgical outcomes according to body mass index (BMI. However, considering the chronic influence of obesity on pelvic floor musculature, it is cautiously speculated that higher BMI could increase stress on pelvic floor and sub-urethral tape, possibly decreasing the long-term success rate in the obese population. We aimed to compare the long-term effects of BMI on the outcomes of MUS between women with retropubic and transobturator approaches.We performed a retrospective analysis on 243 consecutive women who received MUS and were followed up for ≥36 months. The influence of BMI on the success rates was separately estimated and the factors for treatment failure were examined using logistic regression in either approach.The mean follow-up was 58.4 months, and 30.5% were normal weight, 51.0% overweight, and 18.5% obese. Patients received either the retropubic (30.5% or transobturator (69.5% approach. The success rates (% under the transobturator approach differed according to the BMI groups (94.3, 88.6, and 78.6, respectively; P = 0.037 while those under the retropubic approach were not different according to the BMI groups. However, in multivariate models, only the presence of preoperative mixed urinary incontinence (MUI was proven to be the risk factor for treatment failure in the transobturator approach (OR 6.39, P = 0.003. The percent of subjects with MUI was higher in obese women than in non-obese women with the transobturator approach.BMI was not independently associated with failures in either approach. Higher success rates in women with lower BMI in the transobturator approach were attributed to the lower percent of preoperative MUI in those with lower BMI.

  12. Comparative clinical trial of two antigingivitis mouthrinses.

    Science.gov (United States)

    Witt, Jon J; Walters, Patricia; Bsoul, Samer; Gibb, Roger; Dunavent, John; Putt, Mark

    2005-07-01

    To compare the safety and the antiplaque and antigingivitis efficacy of two oral rinses. A randomized, double-blind, parallel groups, single-center study was conducted to evaluate the safety and efficacy of a high bioavailable, alcohol-free 0.07% cetylpyridinium chloride (CPC) rinse (Crest Pro-Health Rinse) and a positive control rinse containing essential oils (EO) and 21.6% ethyl alcohol (Cool Mint Listerine). Seventy-eight healthy adults were enrolled in a modified experimental gingivitis clinical trial. Four weeks before the baseline visit, subjects received a prophylaxis and were instructed to brush twice daily in a manner to approach optimum gingival health. At the end of the 4-week period, subjects were randomly assigned to treatment and instructed to use 20 ml of their assigned product for 30 seconds after brushing twice daily during a 21-day treatment phase. Plaque removal by brushing was prevented during the treatment phase for one mandibular quadrant (experimental gingivitis region) by means of a specially-manufactured tooth shield. Safety and efficacy measurements were obtained at baseline and at the end-of-treatment using the Modified Gingival Index (MGI), Gingival Bleeding Index (GBI), and Modified Quigley-Hein Plaque Index (MQH). At all visits, an oral soft tissue examination was performed for each subject. The efficacy data obtained in the experimental gingivitis region were analyzed with analysis of covariance. Seventy-five subjects completed the study and were included in the data analyses. No statistically significant differences were detected between the two treatment groups for MGI, GBI or MQH measures. Results were similar for shielded interproximal sites. Both treatments were well-tolerated. This randomized, controlled comparative clinical trial demonstrated that rinsing twice daily with the experimental alcohol-free 0.07% CPC rinse provides antiplaque and antigingivitis efficacy similar to that of the positive control EO rinse, a recognized

  13. Did surgical failure and complications affect incontinence-related quality of life in women after transobturator sling procedure?

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    Wen-Chu Huang

    2018-04-01

    Full Text Available Objective: To report the objective outcome, subjective measurement of incontinence-related quality of life (QoL for female urodynamic stress incontinence (USI after transobturator sling surgery (TVT-O and to evaluate the effects of surgical failure and complications on QoL. Materials and methods: We analyzed the data from women who underwent TVT-O for USI and completed two validated QoL questionnaires, the Urogenital Distress Inventory (UDI-6 and Incontinence Impact Questionnaire (IIQ-7 preoperatively and at least 12 months postoperatively. We evaluated the subjective results of QoL questionnaires, objective results and compare the effect of QoL on those with surgical failure and complications after TVT-O surgery. Results: A total of 78 women were followed for a median of 13.5 months (range 12–15 months after surgery. Within this group, 75 (96% were considered subjectively cured or improved after TVT-O. There were significant improvements in the IIQ-7 and total UDI-6 scores postoperatively, as well as in the UDI-6 subscales for urge, stress and voiding dysfunction symptoms. Even the 18 women with objective urodynamic failure had significant improvement in QoL scores. For those with surgical related complications, the QoL scores were also significantly improved. Conclusions: TVT-O for USI resulted in improvement of incontinence-related QoL including urgency, stress, and voiding dysfunction symptoms. Surgical failure and complications didn't impair postoperative QoL. Keywords: Complication, Quality of life, Stress urinary incontinence, Transobturator tape, Urodynamic stress incontinence

  14. Industry sponsorship and selection of comparators in randomized clinical trials.

    Science.gov (United States)

    Lathyris, D N; Patsopoulos, N A; Salanti, G; Ioannidis, J P A

    2010-02-01

    Most clinical trials on medical interventions are sponsored by the industry. The choice of comparators shapes the accumulated evidence. We aimed to assess how often major companies sponsor trials that involve only their own products. Studies were identified by searching ClinicalTrials.gov for trials registered in 2006. We focused on randomized trials involving the 15 companies that had sponsored the largest number of registered trials in ClinicalTrials.gov in that period. Overall, 577 randomized trials were eligible for analysis and 82% had a single industry sponsor [89% (166/187) of the placebo-control trials, 87% (91/105) of trials comparing different doses or ways of administration of the same intervention, and 78% (221/285) of other active control trials]. The compared intervention(s) belonged to a single company in 67% of the trials (89%, 81% and 47% in the three categories respectively). All 15 companies strongly preferred to run trials where they were the only industry sponsor or even the only owner of the assessed interventions. Co-sponsorship typically reflected co-ownership of the same intervention by both companies. Head-to-head comparison of different active interventions developed by different companies occurred in only 18 trials with two or more industry sponsors. Each company generates a clinical research agenda that is strongly focused on its own products, while comparisons involving different interventions from different companies are uncommon. This diminishes the ability to understand the relative merits of different interventions for the same condition.

  15. Dorsal clitoral nerve injury following transobturator midurethral sling

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    Moss CF

    2016-09-01

    Full Text Available Chailee F Moss,1 Lynn A Damitz,2 Richard H Gracely,3 Alice C Mintz,3 Denniz A Zolnoun,2–4 A Lee Dellon5 1Department of Obstetrics and Gynecology, Ohio State University School of Medicine, Columbus, OH, USA; 2Department of Surgery, University of North Carolina at Chapel Hill, NC, USA; 3Department of Endodontics, University of North Carolina at Chapel Hill, NC, USA; 4Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA; 5Department of Plastic and Reconstructive Surgery, Johns Hopkins University School of Medicine, Baltimore, MD, USA Introduction: Transobturator slings can be successfully used to treat stress urinary incontinence and improve quality of life through a minimally invasive vaginal approach. Persistent postoperative pain can occur and pose diagnostic and therapeutic dilemmas. Following a sling procedure, a patient complained of pinching clitoral and perineal pain. Her symptoms of localized clitoral pinching and pain became generalized over the ensuing years, eventually encompassing the entire left vulvovaginal region.Aim: The aim of this study was to highlight the clinical utility of conventional pain management techniques used for the evaluation and management of patients with postoperative pain following pelvic surgery. Methods: We described a prototypical patient with persistent pain in and around the clitoral region complicating the clinical course of an otherwise successful sling procedure. We specifically discussed the utility of bedside sensory assessment techniques and selective nerve blocks in the evaluation and management of this prototypical patient. Results: Neurosensory assessments and a selective nerve block enabled us to trace the source of the patient’s pain to nerve entrapment along the dorsal nerve of the clitoris. We then utilized a nerve stimulator-guided hydrodissection technique to release the scar contracture Conclusion: This case

  16. a randomised trial comparing Foley catheter plus titrated oral ...

    African Journals Online (AJOL)

    Labour induction at term - a randomised trial comparing. Foley catheter plus titrated oral misoprostol solution, titrated oral misoprostol solution alone, and dinoprostone. Baron B Matonhodze, G Justus Hofmeyr, Jonathan Levin. Objectives. To compare three methods of labour induction. Design. Randomised controlled trial.

  17. Randomized controlled trial comparing TVT-O and TVT-S for the treatment of stress urinary incontinence: 2-year results.

    Science.gov (United States)

    Bianchi-Ferraro, Ana Maria H M; Jarmy-DiBella, Zsuzsanna I K; de Aquino Castro, Rodrigo; Bortolini, Maria Augusta T; Sartori, Marair G F; Girão, Manoel J B C

    2014-10-01

    The aim was to compare the efficacy and safety of single-incision sling TVT-Secur (TVT-S) and transobturator midurethral sling (TVT-O) for the treatment of stress urinary incontinence (SUI) over 2 years' follow-up. This is a randomized controlled trial in which women with SUI were randomly assigned to have either TVT-O (n = 56) or TVT-S (n = 66). Exclusion criteria included: voiding dysfunction, detrusor overactivity, and pelvic organ prolapse beyond the hymen. The primary outcomes were objective and subjective cure rates at a follow-up visit at 24 months, defined as a negative stress test and pad test as well as absence of self-reported SUI symptoms. Secondary endpoints included quality of life assessment using the King's Health Questionnaire (KHQ), and complication and reoperation rates. Analysis was performed using intention to treat, and statistical significance was fixed at 5% (p TVT-S and TVT-O groups were 77.3% and 83.6%, while subjective cure rates were 75.7% and 80.3% respectively, with no statistically significant differences between the techniques. There was a significant improvement in all KHQ domains in both groups (p TVT-O, while the long-term one was tape exposure observed in 5.3% of TVT-O and in 7.5% of TVT-S cases. The efficacy of the TVT-S was similar to that of the TVT-O after 2 years' assessment. This cohort will continue to be followed in order to maintain commitment to contributing data on long-term results.

  18. Transobturator tapes are preferable over transvaginal tapes for the management of female stress urinary incontinence: Against

    Directory of Open Access Journals (Sweden)

    Arun Chawla

    2009-01-01

    Full Text Available Midurethral placement of tension-free vaginal tapes with a transvaginal route for stress urinary incontinence achieves higher and better long-term success rates than the transobturator route. Bladder perforations are reported more in transvaginal tape (TVT but incidences of vaginal erosions, extrusion, and groin pain are exceedingly more in TOT groups. There is no clear evidence that transobturator tape (TOT is associated with less post-operative voiding problems than TVT. Major complications such as bowel injuries and significant vascular injuries with TVT are rare. TVT has been found to be superior to TOT and preferable in technically demanding conditions such as prior anti-incontinence operation failures, obese women, and very elevated and scarred lateral cul-de sac. TVT is always preferred in severe grades of stress urinary incontinence and with patients of intrinsic sphincter deficiency (ISD with little or no urethral mobility.

  19. Decreasing transobturator sling groin pain without decreasing efficacy using TVT-Abbrevo.

    Science.gov (United States)

    Shaw, Jonathan S; Jeppson, Peter C; Rardin, Charles R

    2015-09-01

    Groin pain following a transobturator (TO) midurethral sling is not uncommon and can be difficult to manage. We sought to determine if decreasing the mesh burden in the groin would decrease pain. The primary objective was to compare the incidence of post-operative groin pain following placement of full-length TVT-Obturator versus the shorter TVT-Abbrevo. Secondarily, we aimed to compare the efficacy between both devices 6 months after surgery. This is a retrospective cohort study of all women who underwent a TO midurethral sling by the division of urogynecology at one institution between 1 January 2007 and 31 October 2013. Charts were reviewed and the incidence of post-operative groin pain in the two groups dichotomized as present or absent and compared using a Chi-squared test. Validated questionnaire scores of the groups were compared using t tests. There were 125 patients who received a TVT-Obturator and 100 patients who received a TVT-Abbrevo. No differences in demographic data were present between the groups. Twelve patients (9.6 %) in the TVT-Obturator group and 1 patient (1 %) in the TVT-Abbrevo group experienced bothersome groin pain (P value = 0.007). The complete pre- and 6-month post-operative ISI, UDI-6 and PFIQ-7 scores were available for 76 (61 %), 47 (38 %), and 45 (36 %) patients following TVT-Obturator and 57 (57 %), 30 (30 %), and 28 (28 %) following TVT-Abbrevo treatment. At 6 months the mean improvement in questionnaire scores for the TVT-Obturator and TVT-Abbrevo groups were as follows: 5.0 and 5.1 for ISI (P value = 0.9), 8.3 and 7.9 for UDI-6 (P value = 0.8), and 4.8 and 6.1 for PFIQ-7 (P value = 0.4). Use of TVT-Abbrevo reduces post-operative groin pain compared with the full-length TVT-Obturator, without any reduction in efficacy.

  20. Postoperative groin pain and success rates following transobturator midurethral sling placement: TVT ABBREVO® system versus TVT™ obturator system.

    Science.gov (United States)

    Canel, Virginie; Thubert, Thibault; Wigniolle, Ingrid; Fernandez, Hervé; Deffieux, Xavier

    2015-10-01

    Placement of a transobturator midurethral sling (MUS) is the standard surgical treatment for stress urinary incontinence. Most recent MUS procedures have been poorly evaluated. We compared the results using a "new" device expected to reduce postoperative pain, the TVT ABBREVO® system (TVT-Abb), with those using the TVT™ obturator system (TVT-O). This was a retrospective study comparing the use of the TVT-Abb (in 50 patients) and the TVT-O (in 50 patients). The main outcomes were the amount of postoperative pain, the success rate (no reported urinary leakage and negative cough test) with both MUS procedures, and the prevalence of complications. The mean follow-up time was 12 months. The preoperative characteristics of the two groups were comparable. There was less postoperative pain (VAS, 0 to 100) in the TVT-Abb group than in the TVT-O group (12.2 vs. 24.4, p TVT-Abb group and the TVT-O group (8 % vs. 12 %, p = 0.74). The prevalences of perioperative and postoperative complications (bladder/urethral injury, haemorrhage) in the two groups were equal. The success rates were similar at 12 months after surgery (88 % vs. 78 %, p = 0.29). The success rates with TVT-Abb and TVT-O were equal at 12 months after surgery, but there was less immediate postoperative pain with TVT-Abb.

  1. Comparison between three mini-sling surgical procedures and the traditional transobturator vaginal tape technique for female stress urinary incontinence.

    Science.gov (United States)

    Leanza, V; Intagliata, E; Leanza, A; Ferla, F; Leanza, G; Vecchio, R

    2014-01-01

    To compare mini-sling and traditional tension-free operations for female stress urinary incontinence. A systematic review of articles in the Literature published between 2002 and 2012, was conducted. A Pubmed search was performed. Primary outcomes were subjective and objective cure rates at 12 months comparing the three single-incision mini-slings techniques (TVT-Secur, MiniArc and Monarc systems) with the standard midurethral sling procedure TOT (Transobturator Vaginal Tape). Secondary outcomes included peri-operative (vaginal and/or bladder perforation, urine retention, urinary tract infection, bleeding, pain) and post-operative (mesh exposure, de novo urgency, and dyspareunia) complications. In term of objective cure rate at 12 month after surgery, it is evident that TOT at first, and MiniArc are the most effective procedures. The incidence of post-operative urgency and UTI was lower in TOT technique, while vaginal perforation was described in equal frequency both in TOT and in MiniArc procedures. The advantages of the three above described mini-invasive techniques seem to consist into lower cases of urinary retention, pain and bleeding. Furthermore, bladder perforation and bleeding are not described in the Literature for TVT-Secur and Monarc systems. Some single-incision slings look promising and as effective as conventional sub-urethral slings at short term evaluation. However, at this moment a clear statement in favor of the widespread use of single-incision slings cannot be made. More studies must define the efficacy of these techniques.

  2. Comparative trials in registration files of cardiovascular drugs : Comparator drugs and dosing schemes.

    NARCIS (Netherlands)

    Wieringa, NF; Vos, R; de Graeff, PA

    Registration files of 13 cardiovascular drugs were analysed with respect to the number of double-blind phase-III clinical trials, the use of placebo and active comparator drugs and their dosing schemes. Half of the 146 double-blind trials used active comparator drugs. The majority of files included

  3. Anatomical variability in the trajectory of the inside-out transobturator vaginal tape technique (TVT-O)

    NARCIS (Netherlands)

    Hinoul, Piet; Vanormelingen, Linda; Roovers, Jan-Paul; de Jonge, Eric; Smajda, Stéfan

    2007-01-01

    An experimental surgical study on human cadavers was undertaken to assess variability in the trajectory followed by the needle during application of the inside-out transobturator tape suspension (TVT-O) technique. The TVT-O surgical procedures were performed on six fresh female cadavers according to

  4. A randomised trial comparing laparoscopy with laparotomy in the ...

    African Journals Online (AJOL)

    A randomised trial comparing laparoscopy with laparotomy in the management of women with ruptured ectopic pregnancy. ... South African Medical Journal ... Ruptured ectopic pregnancy (REP) is a common gynaecological emergency in resource-poor settings, where laparotomy is the standard treatment despite ...

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

    African Journals Online (AJOL)

    A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety and Cost Effectiveness of Lornoxicam with Diclofenac Sodium in Patients of Osteoarthritis Knee. ... All patients were assessed with visual analogue scale and 100 meter walking test before starting of therapy, at 15 days and at 1, 2 and 3 months of therapy.

  6. Clinical Trial Of Glimepiride Compared With Glibenclamide For ...

    African Journals Online (AJOL)

    Objective: The study was undertaken to compare the efficacy and safety of Glimepiride against Glibenclamide in the management of patients with type 2 DM in Jos, Nigeria. Study design: An open, randomised controlled trial. Setting: Diabetes Clinic of the Jos University Teaching Hospital, Jos, Nigeria. Subjects: Seventy four ...

  7. A cost-effectiveness analysis of retropubic midurethral sling versus transobturator midurethral sling for female stress urinary incontinence.

    Science.gov (United States)

    Seklehner, Stephan; Laudano, Melissa A; Te, Alexis E; Kaplan, Steven A; Chughtai, Bilal; Lee, Richard K

    2014-11-01

    To compare the cost-effectiveness (CE) of retropubic midurethral sling (RMS) versus transobturator midurethral sling (TMS) for the treatment of female stress urinary incontinence (SUI). A Markov chain decision model was created to simulate treatment of SUI with RMS versus TMS. Costing data were obtained from the Medicare RBRVS. Data regarding the efficacy and complications associated with RMS versus TMS was compiled from a literature review of 21 randomized RCTs with a minimum of 12 months follow-up, as were corresponding utilities for different continence states. Deterministic and probabilistic estimates of cost-effectiveness (CE) for each procedure were calculated and compared, and sensitivity analyses were performed. In the base-case deterministic analysis, the efficacy of RMS was 6.275 versus 6.272 QALYs for TMS. QALYs represent a measure of disease burden accounting for both quantity and quality of life lived and are used to assess the monetary value of a medical intervention. The average cost for treatment with RMS however was higher at $9,579 versus $9,017 with TMS. TMS was therefore overall more cost-effective than RMS (CE = $1,438/QALY vs. $1,527/QALY). Sensitivity analysis demonstrated that physician and sling characteristics such as device cost, surgeon fee, efficacy of treatment, operative time, and duration of hospitalization could all affect the relative CE of the therapies. Our study demonstrated that TMS was more cost-effective than RMS as a treatment for female SUI. The efficacy of the two treatments could be affected by physician and sling characteristic factors. © 2013 Wiley Periodicals, Inc.

  8. Complications associated with transobturator sling procedures: analysis of 233 consecutive cases with a 27 months follow-up

    Directory of Open Access Journals (Sweden)

    Dubuisson Jean-Bernard

    2009-09-01

    Full Text Available Abstract Backround The transobturator tape procedure (TOT is an effective surgical treatment of female stress urinary incontinence. However data concerning safety are rare, follow-up is often less than two years, and complications are probably underreported. The aim of this study was to describe early and late complications associated with TOT procedures and identify risk factors for erosions. Methods It was a 27 months follow-up of a cohort of 233 women who underwent TOT with three different types of slings (Aris®, Obtape®, TVT-O®. Follow-up information was available for 225 (96.6% women. Results There were few per operative complications. Forty-eight women (21.3% reported late complications including de novo or worsening of preexisting urgencies (10.2%, perineal pain (2.2%, de novo dyspareunia (9%, and vaginal erosion (7.6%. The risk of erosion significantly differed between the three types of slings and was 4%, 17% and 0% for Aris®, Obtape® and TVT-O® respectively (P = 0.001. The overall proportion of women satisfied by the procedure was 72.1%. The percentage of women satisfied was significantly lower in women who experienced erosion (29.4% compared to women who did not (78.4% (RR 0.14, 95% CI 0.05-0.38, P Conclusion Late post operative complications are relatively frequent after TOT and can impair patient's satisfaction. Women should be informed of these potential complications preoperatively and require careful follow-up after the procedure. Choice of the safest sling material is crucial as it is a risk factor for erosion.

  9. Intraoperative maximal urethral closing pressure measurement: a new technique of tape tension adjustment in transobturator sling surgery?

    Directory of Open Access Journals (Sweden)

    Myung Beum Kang

    2011-12-01

    Full Text Available PURPOSE: Tape tension adjustment is an essential procedure in mid-urethral sling surgery. The goal of this study was to determine if intraoperative maximal urethral closing pressure (MUCP elevation could be used as a reference value for adequate tape tension adjustment and predict transobturator (TOT sling surgery outcome. MATERIALS AND METHODS: A prospective study was performed using MUCP measurements just before tape insertion and just after tension adjustment during surgery. Clinical data including preoperative urodynamic results were collected. The cure rate was determined by questionnaire. Patients were divided into two groups. The MUCP elevation group included patients with a MUCP elevation of more than 10 cmH2O before tape insertion; the others were regarded as the non-elevation group. The cure rate and pre- and postoperative clinical variables were compared between the two groups. RESULTS: A total of 48 patients had TOT surgery. The MUCP elevation group (n=19 and the non-elevation group (n=29 were similar with regard to patient characteristics and the preoperative parameters including age, mixed incontinence prevalence, Q-tip angle, peak flow rate, MUCP and the valsalva leak point pressure (VLPP. The mean follow-up period was nine months. The cure rate was significantly higher in the group with MUCP elevation than in the non-elevation group (84% vs. 52%, p=0.02. There was no significant difference in the mean postoperative peak flow rate between the two groups and there was no retention episode. CONCLUSIONS: MUCP elevation of more than 10 cmH2O just after tape insertion was a prognostic factor.

  10. Long-term outcome of the adjustable transobturator male system (ATOMS): results of a European multicentre study.

    Science.gov (United States)

    Friedl, Alexander; Mühlstädt, Sandra; Zachoval, Roman; Giammò, Alessandro; Kivaranovic, Danijel; Rom, Maximilian; Fornara, Paolo; Brössner, Clemens

    2017-05-01

    To evaluate the long-term effectiveness and safety of the adjustable transobturator male system (ATOMS ® , Agency for Medical Innovations A.M.I., Feldkirch, Austria) in a European-wide multicentre setting. In all, 287 men with stress urinary incontinence (SUI) were treated with the ATOMS device between June 2009 and March 2016. Continence parameters (daily pad test/pad use), urodynamics (maximum urinary flow rate, voiding volume, residual urine), and pain/quality of life (QoL) ratings (visual analogue scale/Leeds Assessment of Neuropathic Symptoms and Signs, International Consultation on Incontinence Questionnaire-Short Form [ICIQ-SF]/Patient Global Impression of Improvement [PGI-I]) were compared preoperatively and after intermediate (12 months) as well as after individual maximum follow-up. Overall success rate, dry rate (ATOMS devices are still functioning; 56 (20%) were removed, the most common reason being local titanium intolerance (41%) and leak/dysfunction (30%). The operating time and continence outcome varied between port generations. In this regard the latest port generation (silicone-covered scrotal port) was superior to its predecessors. Primary implantation (P = 0.002), good physical health (P = 0.001), and no history of radiotherapy (P ATOMS device is safe and shows high treatment efficacy and patient satisfaction in the largest cohort study to date. The latest generation, with its pre-attached silicone-covered scrotal port, is superior to its predecessors. Significantly better results were achieved with primary implantation and in those without a history of radiotherapy. © 2016 The Authors BJU International © 2016 BJU International Published by John Wiley & Sons Ltd.

  11. Decision on performing interim analysis for comparative clinical trials.

    Science.gov (United States)

    Pak, Kyongsun; Jacobus, Susanna; Uno, Hajime

    2017-09-01

    In randomized-controlled trials, interim analyses are often planned for possible early trial termination to claim superiority or futility of a new therapy. While unblinding is necessary to conduct the formal interim analysis in blinded studies, blinded data also have information about the potential treatment difference between the groups. We developed a blinded data monitoring tool that enables investigators to predict whether they observe such an unblinded interim analysis results that supports early termination of the trial. Investigators may skip some of the planned interim analyses if an early termination is unlikely. We specifically focused on blinded, randomized-controlled studies to compare binary endpoints of a new treatment with a control. Assuming one interim analysis is planned for early termination for superiority or futility, we conducted extensive simulation studies to assess the impact of the implementation of our tool on the size, power, expected number of interim analyses, and bias in the treatment effect. The numerical study showed the proposed monitoring tool does not affect size or power, but dramatically reduces the expected number of interim analyses when the effect of the treatment difference is small. The tool serves as a useful reference when interpreting the summary of the blinded data throughout the course of the trial, without losing integrity of the study. This tool could potentially save the study resources and budget by avoiding unnecessary interim analyses.

  12. Severe Groin Pain Following Transobturator Tape Procedure Necessitating Partial Removal of the Tape

    Directory of Open Access Journals (Sweden)

    Gökçe Anık İlhan

    2016-01-01

    Full Text Available Groin pain after transobturator tape (TOT procedure can occur; however, severe groin pain and difficulty in ambulating requring exploration of the obturator compartment and surgical excision of the tape is uncommon. We present a case with severe groin pain after uncomplicated TOT in which the patient could not stand the pain despite conservative treatment. Unlike most cases presented in the literature, the pain could only be releived by partial removal of the tape. Although TOT is an effective and safe procedure in the treatment of stress urinary incontinance, obturator nerve entrapment may rarely occur and mesh dissection and excision may be the only choice to releive the pain in these patients with untolerable severe symptoms.

  13. Outside-in transobturator midurethral sling and the dorsal nerve of the clitoris.

    Science.gov (United States)

    Tate, Susan B; Culligan, Patrick J; Acland, Robert D

    2009-11-01

    An anatomical study on fresh cadavers was done to determine the vulnerability of the dorsal nerve of the clitoris to injury during "outside-in" transobturator sling procedures. The dorsal nerve of the clitoris was identified bilaterally in ten fresh cadavers. Transfixing needles marked the inferomedial border of the obturator foramen. The distance between the foramen border and the nerve was measured. The nerve ran medially in close approximation to the ischiopubic ramus and inferior to the obturator foramen in all specimens. In no instance did the nerve follow an aberrant course traversing the obturator foramen. The mean distance between the inferomedial border of the obturator foramen and the nerve was 9.3 mm, range 3-14 mm. When the "outside-in" technique is used, the introducer cannot come into contact with the dorsal nerve of the clitoris because the introducer would have to pass through the ischio-pubic ramus. This is not anatomically possible.

  14. Chronic vaginal discharge and left leg edema after a transobturator tape procedure.

    Science.gov (United States)

    Kim, Tae-Hee; Lee, Hae-Hyeog; Kim, Jun-Mo

    2014-05-01

    We report on a patient who underwent total vaginal hysterectomy for urinary incontinence 8 years previously with a sling operation using transobturator tape (TOT). She was admitted to our hospital after complaints of vaginal discharge, foul odor, and bleeding, left thigh pain, and edema. Magnetic resonance imaging (MRI) and computed tomography (CT) revealed a fistula tract from the vagina or urethra with remnant sling tape. We removed the remnant tape using intraoperative ultrasonography. This case exemplifies the rare occurrence of a vaginal fistula extending to the obturator, adductor, and pectineus muscles combined with myositis after TOT placement. It is important that urogynecologists recognize that TOT procedures may result in complications accompanied by common recurrent vaginal symptoms, such as vaginal odor and spotting, which can be identified by MRI or CT.

  15. "Sling" retropúbico e transobturatório no tratamento da incontinênca urinária de esforço Retropubic and transobturator sling in treatment of stress urinary incontinence

    Directory of Open Access Journals (Sweden)

    Andrea Lopes Salzedas Tanuri

    2010-01-01

    Full Text Available OBJETIVO: Comparar resultados das técnicas de "sling" retropúbico e transobturador para o tratamento de mulheres com incontinência urinária de esforço (IUE. MÉTODOS: Foram randomizadas 30 pacientes, sendo que 20 se submeteram ao sling retropúbico e 10 ao transobturador. As pacientes foram avaliadas antes e após o tratamento com um, seis e 12 meses, por meio de história clínica, exame físico, questionário de qualidade de vida ("King's Health Questionnaire", teste do absorvente e avaliação urodinâmica. Os grupos foram homogêneos no pré-operatório. RESULTADOS: Houve melhora significante na avaliação da qualidade de vida em ambos os grupos após a terapêutica, sem diferença entre os grupos. Houve diminuição no peso do absorvente para os dois grupos. As taxas de cura pela avaliação urodinâmica em 12 meses foram de 84,2% para o grupo transobturador e 88,8% para o retropúbico. Da mesma forma, a cura subjetiva foi de 85% e 88,8%, respectivamente. Não observamos diferenças entre os grupos consoante as complicações. CONCLUSÃO: As cirurgias deste sling, pelas vias retropúbica e transobturadora, foram eficazes para o tratamento de mulheres com IUE, no seguimento de 12 meses. Observamos elevada taxa de cura e melhora da qualidade de vida com baixos índices de complicações.OBJECTIVE: The aim of this study was to compare results of retropubic and transobturator sling for surgical treatment of female stress urinary incontinence (SUI. METHODS: Thirty randomized patients with SUI were divided in two groups, twenty who underwent the transobturator sling and ten the retropubic sling procedure. .Patients were assessed before and after one, six and twelve months of treatment by clinical history, physical examination, quality of life questionnaire (King's Health Questionnaire, pad test and urodynamic parameters. At preoperative both groups were homogenous. RESULTS: One year after surgery, incontinence and quality of life

  16. A THREE-YEAR EXPERIENCE WITH ANTERIOR TRANSOBTURATOR MESH (ATOM AND POSTERIOR ISCHIORECTAL MESH (PIRM

    Directory of Open Access Journals (Sweden)

    Marijan Lužnik

    2018-02-01

    Full Text Available Background. Use of alloplastic mesh implantates allow a new urogynecologycal surgical techniques achieve a marked improvement in pelvic organ static and pelvic floor function with minimally invasive needle transvaginal intervention like an anterior transobturator mesh (ATOM and a posterior ischiorectal mesh (PIRM procedures. Methods. In three years, between April 2006 and May 2009, we performed one hundred and eightyfour operative corrections of female pelvic organ prolapse (POP and pelvic floor dysfunction (PFD with mesh implantates. The eighty-three patients with surgical procedure TVT-O or Monarc as solo intervention indicated by stress urinary incontinence without POP, are not included in this number. In 97 % of mesh operations, Gynemesh 10 × 15 cm was used. For correction of anterior vaginal prolapse with ATOM procedure, Gynemesh was individually trimmed in mesh with 6 free arms for tension-free transobturator application and tension-free apical collar. IVS (Intravaginal sling 04 Tunneller (Tyco needle system was used for transobturator application of 6 arms through 4 dermal incisions (2 on right and 2 on left. Minimal anterior median colpotomy was made in two separate parts. For correction of posterior vaginal prolapse with PIRM procedure Gynemesh was trimmed in mesh with 4 free arms and tension-free collar. Two ischiorectal long arms for tension-free application through fossa ischiorectale – right and left, and two short arms for perineal body also on both sides. IVS 02 Tunneller (Tyco needle system was used for tension-free application of 4 arms through 4 dermal incisions (2 on right and 2 on left in PIRM. Results. All 184 procedures were performed relatively safely. In 9 cases of ATOM we had perforation of bladder, in 5 by application of anterior needle, in 3 by application of posterior needle and in one case with pincette when collar was inserted in lateral vesico – vaginal space. In 2 cases of PIRM we had perforation of rectum

  17. Comparison of Effectiveness between Tension-Free Vaginal Tape (TVT) and Trans-Obturator Tape (TOT) in Patients with Stress Urinary Incontinence and Intrinsic Sphincter Deficiency.

    Science.gov (United States)

    Kim, Hyeong Gon; Park, Hyoung Keun; Paick, Sung Hyun; Choi, Woo Suk

    2016-01-01

    The aim of this study was to compare the two types of mid-urethral slings for stress urinary incontinence (SUI) with intrinsic sphincter deficiency (ISD). This retrospective study included patients who underwent tension-free vaginal tape (TVT) procedure or transobturator tape (TOT) procedure by a single surgeon for SUI with ISD, defined as Valsalva leak point pressure (VLPP) TVT and 52 patients received TOT. Age, underlying diseases, Stamey grade, cystocele grade, and presence of urge incontinence were not significantly different between the two groups. Urodynamic parameters including maximal urethral closing pressure, detrusor overactivity, VLPP, urethral hypermobility (Q-tip ≥ 30°), were also comparable between the two groups. Success rate was significantly higher in the TVT group than in the TOT group (95.2% vs. 82.7%, p = 0.009). On multivariate analysis, only TOT surgery (OR = 3.922, 95%CI = 1.223-12.582, p = 0.022) was a risk factor for failure following surgical treatment. TVT is more effective than TOT in treatment of female SUI with ISD.

  18. Comparison of Effectiveness between Tension-Free Vaginal Tape (TVT and Trans-Obturator Tape (TOT in Patients with Stress Urinary Incontinence and Intrinsic Sphincter Deficiency.

    Directory of Open Access Journals (Sweden)

    Hyeong Gon Kim

    Full Text Available The aim of this study was to compare the two types of mid-urethral slings for stress urinary incontinence (SUI with intrinsic sphincter deficiency (ISD.This retrospective study included patients who underwent tension-free vaginal tape (TVT procedure or transobturator tape (TOT procedure by a single surgeon for SUI with ISD, defined as Valsalva leak point pressure (VLPP < 60 cmH2O in a urodynamic study. Cases of neurogenic bladder, previous SUI surgery, and concomitant cystocele repair were excluded. The primary outcome was treatment success at 12 months, defined by self-reported absence of symptoms, no leakage episodes recorded, and no retreatment.Among the 157 women who were included in the final analysis, 105 patients received TVT and 52 patients received TOT. Age, underlying diseases, Stamey grade, cystocele grade, and presence of urge incontinence were not significantly different between the two groups. Urodynamic parameters including maximal urethral closing pressure, detrusor overactivity, VLPP, urethral hypermobility (Q-tip ≥ 30°, were also comparable between the two groups. Success rate was significantly higher in the TVT group than in the TOT group (95.2% vs. 82.7%, p = 0.009. On multivariate analysis, only TOT surgery (OR = 3.922, 95%CI = 1.223-12.582, p = 0.022 was a risk factor for failure following surgical treatment.TVT is more effective than TOT in treatment of female SUI with ISD.

  19. Randomized trial comparing office flexible to rigid cystoscopy in women.

    Science.gov (United States)

    Quiroz, Lieschen H; Shobeiri, S Abbas; Nihira, Mikio A; Brady, Jordan; Wild, Robert A

    2012-11-01

    The objective of the study was to compare office rigid cystoscopy (RC) versus flexible cystoscopy (FC) in women. This was a prospective randomized trial comparing FC to RC. Aims were to assess 1-week post-procedural complications, compare procedure pain scores, and to assess physician perception of patient discomfort. Pain scores were assessed by visual analogue scale (VAS) and 5-point verbal descriptor scale (VDS). Chi-square was used for categorical comparison and t tests or Wilcoxon test for continuous variables. One hundred women were enrolled. The mean age of participants was 59.7 years (± SD 14.6), and 91 % were Caucasian. This was the first cystoscopy for 86 % of participants. On the 1-week post-procedure questionnaire (85 % response rate), participants in the FC group reported urinary frequency more often than in the RC group (p = 0.041). The FC group reported urgency with urination lasting 1-2 days (p = 0.030) and burning with urination lasting >3 days (p = 0.026), more than the RC group. These symptoms did not persist at 7 days. The duration of the procedure was slightly faster for the FC group (4.6 ± 1.8 min vs 5.7 ± 3.4 min, p = 0.046). Median VAS scores were 0.9 (0.1-2.72) for the FC group and 0.5 (0-2.4) for the RC group (p = 0.505). There were no significant differences between patient or physician perception of pain in either group. Urinary frequency and duration of urinary burning post procedure occurred more frequently in the FC group, although these symptoms were transient. Both office FC and RC are generally well tolerated in women with overall low morbidity.

  20. Effect of midurethral sling (transobturator tape surgery on female sexual function

    Directory of Open Access Journals (Sweden)

    Fredrick Paul

    2015-01-01

    Full Text Available Introduction: Transobturator tapes (TOT are frequently used in the management of female stress urinary incontinence (SUI. We evaluated the effect of TOT on sexual function in Indian women with stress urinary incontinence. Materials and Methods: 34 sexually active women (mean age 42.38 years with SUI were evaluated before TOT placement for sexual function using the NSF-9 sexual scoring system questionnaire. The evaluation was repeated at the 3 rd , 6 th and 12 th months post surgery and then yearly. Results: There was significant improvement in scores in all domains of sexual function post-surgery. The frequency improved in 24 (70.5% patients, lubricacy improved in 12 (57.1% patients, orgasm improved in 21 (67.1% patients, pain improved in 14 (70% patients and, in leaking patients, sexual satisfaction improved in 85.7% while in non-leaking patients improvement was seen in 40%. Sexual relation was not satisfactory in 26 (76.4% of the patients before surgery; of them, 21 (80% patients had improved sexual satisfaction after surgery. De novo urgency and dyspareunia developed in one and two patients, respectively. Conclusions: The TOT procedure has no significant negative impact on sexual function and it significantly improves female sexual function and overall sexual satisfaction in majority of the patients with SUI.

  1. Comparing abrupt and gradual smoking cessation: a randomized trial.

    Science.gov (United States)

    Etter, Jean-François

    2011-11-01

    To compare abrupt and gradual smoking cessation. Randomized trial and observational study, Internet, 2007-2010. Smokers with no strong preference for abrupt or gradual quitting were randomly assigned to quitting immediately (n=472), or to gradually reducing their cigarette consumption over 2 weeks and then quit (n=502). Smokers who strongly preferred to quit abruptly were instructed to do so immediately (n=2456), those who strongly preferred gradual were instructed to reduce their cigarette consumption over 2 weeks, then quit (n=1801). Follow-up was conducted 4 weeks after target quit dates. Those who preferred abrupt quitting were the most motivated to quit and the most confident in their ability to quit. At follow-up, quit rates were 16% in those who preferred abrupt cessation, 7% in those who preferred gradual cessation and 9% in those who had no preference (pmotivation to quit and confidence in ability to quit: those who had low levels of motivation or low levels of confidence were more likely to quit at follow-up if they preferred and used abrupt rather than gradual. In those who had no strong preference for either method, abrupt and gradual produced similar results. Those who preferred and used the abrupt method were more likely to quit than those who preferred and used the gradual method, in particular when they had low motivation and confidence. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  2. Clinical trial of osteoarthritis jamu formula compare to piroxicam

    Directory of Open Access Journals (Sweden)

    Danang Ardiyanto

    2016-12-01

    is a lack of evidence of its efficacy and safety. The objectives of study were to investigate the efficacy and safety of  a traditional formula for OA. Methods: Design of the study was a randomized clinical trial (RCT involved 123 patients (subjects for 28 days intervention. This study was conducted between March - December 2014 with 30 physicians were participated at 20 regencies in Indonesia. The variables measured were VAS score, PGAP functional status assessment (FSA, and Short Form (SF-36 to assess jamu efficacy in comparison to piroxicam. To evaluate the safety of jamu formula using values of SGOT, SGPT, BUN, and creatinine. Result: The jamu formula administration effects can reduce VAS significantly  (p<0.05  if it was compared to baseline. FSA score of jamu formula group was decreased significantly (p=0.000 when compared to the start of intervention. Short Form (SF-36 of jamu formula group were significantly improved when compared with baseline value. The result of the three parameters between jamu group and piroxicam group should not significantly different. There was no difference in those parameters between both groups (p>0.05. In biological parameters, SGPT, SGOT, BUN, and creatinine level, showed normal range in both groups. Conclusion: This study showed that the efficacy and safety of jamu formula was clinically comparable to piroxicam after 28 days of treatment. Keywords: efficacy, safety, RCT, jamu formula  

  3. Five-year experience with the adjustable transobturator male system for the treatment of male stress urinary incontinence: a single-center evaluation.

    Science.gov (United States)

    Mühlstädt, Sandra; Friedl, Alexander; Mohammed, Nasreldin; Schumann, André; Weigand, Karl; Kawan, Felix; Göllert, Christian; Kahlert, Christin; Theil, Gerit; Fischer, Kersten; Fornara, Paolo

    2017-01-01

    We report on our 5-year experience with the adjustable transobturator male system (ATOMS ®, A.M.I., Feldkirch, Austria). Between 10-2009 and 10-2014, 54 patients received an ATOMS. The mean follow-up of this retrospective observational trial was 27.5 ± 18.4 (2.3-59) months. Within each follow-up, the following were evaluated: micturition protocol, 24-h pad count, uroflowmetry and residual volume. Statistical analysis was performed with SigmaPlot ® 11.0, p safty pad"/day), while 29.6 % achieved at least an "improvement" of about more than 50 % (1-2 pads/day), which corresponds to an overall success rate of 77.7 %. The mean number of pads/day decreased from 7.7 to 1.6. Regarding the initial degree of SUI, patients with mild or moderate incontinence had a significantly better outcome (p = 0.002, 95 % CI 0.9066 to 2.760). Postoperative complications were scaled according to the Clavien classification, in which we have seen 4 grade I-, 1 grade IIIa- and 9 grade IIIb-complications (overall 25.9 %). The evaluation of quality of life by ICIQ-SF showed a significant improvement (p = 0.0001, 95 % CI -14.56 to -11.75). The treatment of male SUI using the ATOMS incontinence system achieved the best results in patients with mild and moderate incontinence. For severe incontinent patients, the system represents an efficient alternative.

  4. The Adjustable Transobturator Male System in Stress Urinary Incontinence After Transurethral Resection of the Prostate.

    Science.gov (United States)

    Friedl, Alexander; Schneeweiss, Jenifer; Stangl, Kathrin; Mühlstädt, Sandra; Zachoval, Roman; Hruby, Stephan; Gründler, Therese; Kivaranovic, Danijel; Fornara, Paolo; Lusuardi, Lukas; Brössner, Clemens

    2017-11-01

    To investigate the efficacy and safety of the Adjustable Transobturator Male System (ATOMS) in men with stress urinary incontinence after transurethral resection of the prostate (TURP). From a large international prospectively administrated ATOMS register, we identified 49 patients with an ATOMS device as a result of persistent stress urinary incontinence after TURP. For evaluation, the men were divided into standard transurethral resection of the prostate (sTURP) and palliative transurethral resection of the prostate (pTURP) in radiated patients. Baseline and follow-up measurements included continence parameters, urodynamics, quality-of-life surveys (Patient Global Impression-Improvement and International Consultation on Incontinence Questionnaire-Short Form), and pain ratings. The dry rate (0-1 security pad/vs 10%, P = .0171) and infection was the most common side effect (50%) observed. Neither intraoperative nor Clavien-Dindo 4 and 5 adverse events were recorded. In sTURP and pTURP, the median daily pad count and the pad test improved significantly (all P <.001), and quality-of-life parameters shifted to a high satisfaction level (P <.001 and P = .001). Urodynamics remained unchanged and postoperative pain was not an issue. The ATOMS device shows promising treatment outcomes in patients after TURP and a similar efficacy as in postprostatectomy incontinence. There is no difference in continence outcome between sTURP and pTURP; however, a higher removal rate was found after pTURP, which may be important for patient counseling. Copyright © 2017 Elsevier Inc. All rights reserved.

  5. Impact of transobturator vaginal tape on female stress urinary incontinence and sexual function

    Directory of Open Access Journals (Sweden)

    Tarek Soliman

    2017-12-01

    Full Text Available Objective: To evaluate the effect of vaginal transobturator tape (TOT on female stress urinary incontinence (SUI and sexual function. Patients and methods: In all, 145 patients with SUI underwent TOT repair using the ‘outside–in’ technique. All patients had been sexually active in the previous 6 months. Patients were evaluated by history, routine laboratory investigations, cough stress test, abdominopelvic ultrasonography, and full urodynamic studies. The preoperative data assessed included: age, parity, body mass index, menopausal status, and Stamey grade of SUI. The intraoperative data assessed included: operative time, blood loss, and hospital stay; intra- and postoperative complications were also assessed. At 2 weeks after discharge, patients were followed-up with a routine examination and cough stress test. After 6 months’ patients were assessed by urodynamic studies, maximum urinary flow rate, post-void residual urine volume. The following questionnaires were completed before and at 6 months after TOT insertion: International Consultation of Incontinence Questionnaire-Short Form (ICIQ-SF, Urogenital Distress Inventory-Short Form (UDI-6, and Female Sexual Function Index (FSFI. Results: All sociodemographic data of the 145 patients were collected. According to ICIQ-SF scores, 122 patients were cured, 19 had improved, and four failed. There were significant improvements in the UDI-6 and FSFI scores, indicating that the women had significant improvement in their sexual life. There were six cases of urinary tract infection, five cases had a fever, and eight patients complained of groin or thigh pain postoperatively. Conclusions: Correction of SUI using TOT appears to have a positive effect on female sexual function. Keywords: TOT, Stress urinary incontinence, Female sexual function, FSFI, Menopause

  6. Results of the surgical correction of urinary stress incontinence according to the type of transobturator tape utilized

    Directory of Open Access Journals (Sweden)

    Bárbara Padilla-Fernández

    2013-09-01

    Full Text Available Objectives: To analyze the short and long term results of tapes of different materials used to treat stress urinary incontinence (SUI. A secondary objective was to evaluate the ability to adjust the tape after implantation. Materials and methods: Retrospective chart review of 355 patients with SUI operated between March 2003 and October 2011. Eight different types of transobturator tapes were used: Gynecare TVT-O®, Monarc®, SAFYRE®, Contasure KIM®, I-Stop®, DynaMesh®, Aris® Bandellete and Swing-band®. Results and complications were recorded. Results: The mean age at operation was 61 years. Correction of SUI was achieved in 87.88% of cases. The best results were obtained with Contasure KIM® (98.26 % continence. The tape was well tolerated and was elastic enough to be able to be adjusted 48-72 hours after implantation without deformation. Slings with macropores and over lock stiches on the superior and inferior borders presented the lower rates of postoperative urinary retention, pain, perior postoperative bleeding and urinary tract infections. Conclusions: Transobturator tension free tapes require a short operation time and have a low complication rate. The possibility of adjustment in the early postoperative period increases the success rate and reduces complications. Knotless meshes with macropores and over lock stiches appear to be better balanced, are quite resistant to stretching and deformation when readjusted after implantation and present a low infection rate.

  7. Acute migraine therapy: recent evidence from randomized comparative trials

    DEFF Research Database (Denmark)

    Mett, A.; Tfelt-Hansen, P.

    2008-01-01

    (1) A wide array of data regarding acute migraine treatment are available, but few trials strictly adhere to International Headache Society guidelines for patient inclusion criteria. (2) Triptans appear to have similar efficacy profiles, but among newer triptans, almotriptan offers improved...

  8. Effectiveness of Retropubic Tension-Free Vaginal Tape and Transobturator Inside-Out Tape Procedures in Women With Overactive Bladder and Stress Urinary Incontinence

    Science.gov (United States)

    Han, Ji-Yeon; Choo, Myung-Soo; Lee, Young-Suk; Seo, Ju Tae; Kim, Jang Hwan; Kim, Young Ho

    2013-01-01

    Purpose We compared the effectiveness of the retropubic tension-free vaginal tape (TVT) and the transobturator inside-out tape (TVT-O) in treating symptoms of overactive bladder (OAB) in women with stress urinary incontinence (SUI). Methods Women with urodynamic SUI and OAB (mean urgency episodes ≥1 and frequency ≥8/24 hours on a 3-day voiding diary) were assigned to the TVT or TVT-O group. Preoperative measures were based on a urodynamic study, 3-day voiding diary, the Bristol Female Lower Urinary Tract Symptoms questionnaire (BFLUTSSF), and the urgency perception scale (UPS). At 12 postoperative months, the 3-day voiding diary, symptoms questionnaire, patient satisfaction, and standing stress test were assessed. The primary endpoint was change in the number of urgency episodes/24 hours from baseline to 12 months. Results In this group of 132 women, 42 received TVT and 90 received TVT-O. The mean urgency episodes/24 hours decreased from 6.3±5.5 to 1.6±3.2 in the TVT group and from 5.1±4.4 to 1.8±3.0 in the TVT-O group. The mean percent change was significantly greater after TVT than after TVT-O (73% vs. 60%, P=0.049). All subscales of BFLUTSSF and UPS were significantly improved using either method, with significantly greater improvement seen in the quality of life (QoL) domain after TVT (P=0.002). There were no significant differences in the cure and satisfaction rates between the two groups. Conclusions Intervention with the TVT or the TVT-O significantly improved symptoms of OAB in women with SUI and OAB. Urgency and QoL significantly improved after TVT compared with that after TVT-O. PMID:24143294

  9. Is the adjustable transobturator system ATOMS® useful for the treatment of male urinary incontinence in low to medium volume urological centers?

    Science.gov (United States)

    Manso, M; Alexandre, B; Antunes-Lopes, T; Martins-da-Silva, C; Cruz, F

    2018-05-01

    Urinary incontinence (UI) is a complication of radical prostatectomy (RP) and transurethral resection of the prostate (TURP). The gold-standard treatment is the artificial urinary sphincter, however, new treatments have been investigated. To examine the outcome of an adjustable transobturator male system (ATOMS ® ) in men with UI after prostatic surgery in a low to medium volume continence center. Twenty-five men with UI were implanted with ATOMS ® system between 2012 and 2014. The most common indication was UI after RP (92%), followed by UI after TURP (8%). Eleven patients (44%) had received adjuvant external beam radiotherapy (RT). Patients were considered to be 'dry' if they stopped wearing pads or needed just one protective pad per day; and improved if the daily number of pads used decreased by at least half. The Incontinence Quality of Life questionnaire (ICIQ-SF) was used, adding a verbal question about the satisfaction of the patient considering the outcome. After a mean follow-up of 21.56 months, 64% were dry and 8% revealed a significant improvement. The success of the procedure was negatively correlated with the severity of the previous UI and with previous treatment with RT. Concerning patients satisfaction, 84% of the patients would repeat the procedure. ATOMS ® offers good rates of cure and improvement of UI after prostatic surgery with a reasonable rate of minor complications. The results of this study, performed in a low to medium volume continence center, are comparable to the results achieved in high volume continence centers. Copyright © 2017 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

  10. Epizone: Interlaboratory Ring Trial to Compare Dna Transfection Efficiencies

    DEFF Research Database (Denmark)

    Dory, Daniel; Albina, Emmanuel; Kwiatek, Olivier

    of viruses by reverse genetics and/or generation of mutated viruses. A large number of transfection chemicals like calcium phospate, branched organic compounds, liposomes, cationic polymers etc. are available on the market which are used by different laboratories for different cell lines. To obtain...... an overview on the efficiencies of varying transfection procedures, an interlaboratory ring trial was initiated within EPIZONE theme 5. A total of 15 participitating laboratories from 7 member institutions received RK13 cells, plasmid DNA encoding firefly luciferase under the transcriptional control...... of the human cytomegalovirus major immediate early promoter, a specially developed lysis buffer and a detailed protocol. Transfected cells were harvested in the laboratories of the participants, frozen and sent to the FLI where both the luciferase activity and protein content of the individual samples were...

  11. A Randomized Trial Comparing Skin Antiseptic Agents at Cesarean Delivery.

    Science.gov (United States)

    Tuuli, Methodius G; Liu, Jingxia; Stout, Molly J; Martin, Shannon; Cahill, Alison G; Odibo, Anthony O; Colditz, Graham A; Macones, George A

    2016-02-18

    Preoperative skin antisepsis has the potential to decrease the risk of surgical-site infection. However, evidence is limited to guide the choice of antiseptic agent at cesarean delivery, which is the most common major surgical procedure among women in the United States. In this single-center, randomized, controlled trial, we evaluated whether the use of chlorhexidine-alcohol for preoperative skin antisepsis was superior to the use of iodine-alcohol for the prevention of surgical-site infection after cesarean delivery. We randomly assigned patients undergoing cesarean delivery to skin preparation with either chlorhexidine-alcohol or iodine-alcohol. The primary outcome was superficial or deep surgical-site infection within 30 days after cesarean delivery, on the basis of definitions from the Centers for Disease Control and Prevention. From September 2011 through June 2015, a total of 1147 patients were enrolled; 572 patients were assigned to chlorhexidine-alcohol and 575 to iodine-alcohol. In an intention-to-treat analysis, surgical-site infection was diagnosed in 23 patients (4.0%) in the chlorhexidine-alcohol group and in 42 (7.3%) in the iodine-alcohol group (relative risk, 0.55; 95% confidence interval, 0.34 to 0.90; P=0.02). The rate of superficial surgical-site infection was 3.0% in the chlorhexidine-alcohol group and 4.9% in the iodine-alcohol group (P=0.10); the rate of deep infection was 1.0% and 2.4%, respectively (P=0.07). The frequency of adverse skin reactions was similar in the two groups. The use of chlorhexidine-alcohol for preoperative skin antisepsis resulted in a significantly lower risk of surgical-site infection after cesarean delivery than did the use of iodine-alcohol. (Funded by the National Institutes of Health and Washington University School of Medicine in St. Louis; ClinicalTrials.gov number, NCT01472549.).

  12. Treatment of female stress urinary incontinence using suburethral slings: comparative, retrospective, observational study of two surgical techniques.

    Science.gov (United States)

    Castroviejo-Royo, F; Martinez-Sagarra-Oceja, J M; Marina-García-Tuñón, C; Conde-Redondo, C; Rodríguez-Toves, L A; González-Tejero, C

    2013-10-01

    The treatment of female stress urinary incontinence has undergone a revolution in recent years due the emergence on the market of suburethral slings. The aim of this study is to compare two surgical techniques for treating stress urinary incontinence: Monarc™ (transobturator suburethral sling) and MiniArc(®) (single-incision suburethral mini-sling). Comparative, retrospective, observational study from January 2005 to December 2011 on 317 women diagnosed with stress urinary incontinence. Of these, 214 were treated with the Monarc™ transobturator suburethral sling, and 103 were treated with the MiniArc(®) mini-sling. The results were treated with SPSS v.15 software, and the statistical significance was P≤.005. The two patients groups were homogeneous in terms of age, number of births, presence of urgency urinary incontinence and prior hysterectomy. There were significant differences in hospital stay, surgical time and early complications in favour of the MiniArc(®), technique, but overall there were no significant differences in the late complications. Some 84% of the patients treated with the Monarc™ transobturator sling were cured compared with the 72% of patients in whom we implanted a MiniArc(®), a difference that was statistically significant. We need to perform more high-quality, prospective and randomised studies with larger numbers of patients and longer follow-up times to confirm or disprove the difference that we found in the success rate for the Monarc™ transobturator suburethral sling. Copyright © 2012 AEU. Published by Elsevier Espana. All rights reserved.

  13. Double-Blind Comparative Trial of Parenteral Lorazepam and ...

    African Journals Online (AJOL)

    Lorazepam, a new sedative drug of the benzodiazepine group, was compared in a double-blind study with a papaveretumjhyoscine mixture in a series of 50 patients awaiting surgery. No difference between the drugs in terms of sedation or side-effects was detected. S. Afr. Med. J., 48, 862 (1974).

  14. A randomised controlled trial comparing the effect of adjuvant ...

    African Journals Online (AJOL)

    Background: Intrathecal adjuvants are added to local anaesthetics to improve the quality of neuraxial blockade and prolong the duration of analgesia during spinal anaesthesia. Used intrathecally, fentanyl improves the quality of spinal blockade as compared to plain bupivacaine and confers a short duration of post ...

  15. A randomised controlled trial comparing the effect of adjuvant ...

    African Journals Online (AJOL)

    29. Tucker AP, Lai C, Nadeson R, Goodschild CS. Intra- thecal midazolam I: a cohort study investigating safety. Anesth Analg. 2004;98(6):1512-20. 30. Safari F, Dabbagh A, Sharifnia M. The effect of ad- juvant midazolam compared with fentanyl on the dura- tion of spinal anesthesia with 0.5% bupivacaine in opium abusers.

  16. Clinical trial comparing excision and primary closure with modified ...

    African Journals Online (AJOL)

    The aim of this study was to compare modified Limberg flap procedure with excision and primary closure in the treatment of uncomplicated pilonidal disease. Methods: This study was conducted on 120 patients with uncomplicated sacrococcygeal pilonidal disease that were randomly allocated into two groups: group I ...

  17. A randomised trial comparing laparoscopy with laparotomy in the ...

    African Journals Online (AJOL)

    comparing laparoscopic surgery with laparotomy in the surgical management of women with REP. Objective. ... The outcome measures were operating time, hospital stay, pain scores and analgesic requirements, blood transfusion, time to ... the sutures at the local clinic were made for 7 days after the procedure. Assessment ...

  18. Pain Relief in Labor: A Randomized Controlled Trial Comparing ...

    African Journals Online (AJOL)

    Conclusions: This study showed that 600 mg intramuscular paracetamol provides similar and modest pain relief in labor when compared to 100 mg intramuscular tramadol. It also has fewer maternal adverse effects and favorable neonatal outcome such as tramadol. It is concluded that intramuscular paracetamol is simple, ...

  19. Trial of Labor Compared With Cesarean Delivery in Superobese Women.

    Science.gov (United States)

    Grasch, Jennifer L; Thompson, Jennifer L; Newton, J Michael; Zhai, Amy W; Osmundson, Sarah S

    2017-11-01

    To examine whether labor compared with planned cesarean delivery is associated with increased maternal and neonatal morbidity. We conducted a retrospective cohort study of all women with body mass indexes (BMIs) at delivery of 50 or greater delivering a live fetus at 34 weeks of gestation of greater between January 1, 2008, and December 31, 2015. Pregnancies with multiple gestations and major fetal anomalies were excluded. The primary outcome was a composite of maternal and neonatal morbidity and was estimated to be 50% in superobese women based on institutional data. A sample size of 338 women determined the study period and was selected to show a 30% difference in the incidence of the primary outcome between the two groups. Multivariate logistic regression adjusted for potential confounders. There were 344 women with BMIs of 50 or greater who met eligibility criteria, of whom 201 (58%) labored and 143 (42%) underwent planned cesarean delivery. Women who labored were younger, more likely to be nulliparous, and less likely to have pre-existing diabetes. Among women who labored, 45% underwent a cesarean delivery, most commonly for labor arrest (61%) or nonreassuring fetal status (28%). Composite maternal and neonatal morbidity was reduced among women who labored even after adjusting for age, parity, pre-existing diabetes, and prior cesarean delivery (adjusted odds ratio 0.42, 95% CI 0.24-0.75). In the subgroup of women (n=234) who underwent a cesarean delivery, whether planned (n=143) or after labor (n=91), there were no differences in maternal and neonatal morbidity except that severe maternal morbidity was increased in women (n=12) who labored (8.8% compared with 2.1%, relative risk 4.2, 95% CI 1.14-15.4). Despite high rates of cesarean delivery in women with superobesity, labor is associated with lower composite maternal and neonatal morbidity. Severe maternal morbidity may be higher in women who require a cesarean delivery after labor.

  20. An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction

    NARCIS (Netherlands)

    M.L. Simoons (Maarten); E.J. Topol (Eric); R.M. Califf (Robert); F.J.J. van de Werf (Frans); P.W. Armstrong (Paul); P.E. Aylward (Philip Edmund); G.I. Barbash; E.R. Bates (Eric); A. Betriu; J.H. Chesebro (James); J.J. Col (Jacques); D.P. de Bono (David); J.M. Gore (Joel); A.D. Guerci (Alan); J.R. Hampton (John)

    1993-01-01

    textabstractBACKGROUND: The relative efficacy of streptokinase and tissue plasminogen activator and the roles of intravenous as compared with subcutaneous heparin as adjunctive therapy in acute myocardial infarction are unresolved questions. The current trial was designed to compare new, aggressive

  1. Comparative Effectiveness Trials of Imaging-Guided Strategies in Stable Ischemic Heart Disease.

    Science.gov (United States)

    Shaw, Leslee J; Phillips, Lawrence M; Nagel, Eike; Newby, David E; Narula, Jagat; Douglas, Pamela S

    2017-03-01

    The evaluation of patients with suspected stable ischemic heart disease is among the most common diagnostic evaluations with nearly 20 million imaging and exercise stress tests performed annually in the United States. Over the past decade, there has been an evolution in imaging research with an ever-increasing focus on larger registries and randomized trials comparing the effectiveness of varying diagnostic algorithms. The current review highlights recent randomized trial evidence with a particular focus comparing the effectiveness of cardiac imaging procedures within the stable ischemic heart disease evaluation for coronary artery disease detection, angina, and other quality of life measures, and major clinical outcomes. Also highlighted are secondary analyses from these trials on the economic findings related to comparative cost differences across diagnostic testing strategies. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  2. Series: Pragmatic trials and real world evidence: Paper 5. Usual care and real life comparators.

    Science.gov (United States)

    Zuidgeest, Mira G P; Welsing, Paco M J; van Thiel, Ghislaine J M W; Ciaglia, Antonio; Alfonso-Cristancho, Rafael; Eckert, Laurent; Eijkemans, Marinus J C; Egger, Matthias

    2017-10-01

    Pragmatic trials may deliver real-world evidence on the added value of new medications compared with usual care and inform decision making earlier in development. This fifth paper in a series on pragmatic trials in the Journal discusses usual care as a comparator and the allocation of treatment strategies. The allocation and implementation of treatment strategies should resemble clinical practice as closely as possible. Randomization at the level of the site, as opposed to at the individual level, may be preferred. Data analysis according to the intention-to-treat principle is recommended, and crossover between treatment arms and strong treatment preferences may be accounted for in the study design in specific situations. Although usual care is the comparator of choice, this may differ substantially between centers and countries complicating comparator choice. Using clinical guidelines to define usual care can be helpful in standardizing comparator treatments; however, this may decrease the applicability of the results to real-life settings. Conversely, using multiple usual-care treatment arms will increase the complexity of the study. The specific objectives of the trial and design choices should be discussed with all stakeholders to realize the full potential of the pragmatic trial. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.

  3. Evaluation of Presenting Symptoms and Long-Term Outcomes of Patients Requiring Excision of a Transobturator Tape (TOT).

    Science.gov (United States)

    Forde, J C; Davis, N F; Creagh, T A

    2015-10-01

    The transobturator tape (TOT) is an effective treatment for stress urinary incontinence (SUI). Erosion of TOT mesh is a recognised complication requiring excision. A retrospective analysis of 228 females undergoing a TOT procedure over 4 years identified 16 patients (7%) that underwent excision of eroded mesh. Mean age of patients requiring excision was 48.8 years and mean weight was 72.7kg. Mean time to re-presentation was 14.5 months. Presenting symptoms included dyspareunia in 9 patients (56.2%), dysuria in 3 (18.7%), persistent incontinence in 3 (18.7%) and groin pain in one patient. Ten patients (62.5%) had a prior urogynecological procedure. After excision of eroded tape-mesh, 7 (43.7%) required a rectus fascial sling and 4 (25%) underwent repeat TOT for recurrence of SUI. Five patients (31.2%) required no further surgery. At present 10 patients (62.5%) report resolution of SUI, 4 (25%) report mild SUI and 2 (12.5%) patients have moderate/severe SUI. Resolution of symptoms occurred in the majority of patients after excision of eroded mesh and an additional anti-incontinence procedure.

  4. Morphology and dynamics of the male pelvic floor before and after retrourethral transobturator sling placement: first insight using MRI.

    Science.gov (United States)

    Soljanik, Irina; Bauer, Ricarda M; Becker, Armin J; Stief, Christian G; Gozzi, Christian; Soljanik, Olga; Kirchhoff, Sonja M

    2013-06-01

    We prospectively evaluated changes in morphology and dynamics of the male pelvic floor on magnetic resonance imaging (MRI) associated with retrourethral transobturator sling (RTS) placement. Twenty-six men with post-prostatectomy incontinence consecutively underwent functional cine-MRI before and 12 months after RTS. The membranous urethra length (MUL) and severity of periurethral/urethral fibrosis were assessed on static MRI. A lowering of the posterior bladder wall (BPW), the bladder neck (BN), the external urinary sphincter (EUS) and symphysial rotation of these structures were analysed on dynamic MR images. The success rate was defined as cure (0-1 dry 'security' pad) or improvement (pad reduction ≥ 50 %). The success rate was 77 % (20/26 patients). The mean follow-up was 20.4 months. The MUL significantly increased post-operatively (p elevation of the BPW (p elevation of the BN, BPW and EUS. De novo development of periurethral or urethral fibrosis seems not to be confirmed. The RTS failure was related to the severity of pre- and post-operative periurethral fibrosis. The impact of MRI on pre-operative diagnostics of RTS failure needs further evaluation.

  5. Comparing the effectiveness of mindfulness-based stress reduction and multidisciplinary intervention programs for chronic pain: a randomized comparative trial.

    Science.gov (United States)

    Wong, Samuel Yeung-Shan; Chan, Frank Wan-Kin; Wong, Rebecca Lai-Ping; Chu, Ming-Chi; Kitty Lam, Yu-Yuk; Mercer, Stewart W; Ma, S Helen

    2011-10-01

    Research suggests that an 8-week Mindfulness-Based Stress Reduction (MBSR) program (a structured form of meditation) might be effective in the treatment of various health problems including chronic pain. Our objective was to compare the clinical effectiveness of the MBSR program with a multidisciplinary pain intervention (MPI) program in terms of pain intensity, pain-related distress, quality of life, and mood in patients with chronic pain. A randomized, comparative clinical trial was conducted, including 6-month posttreatment follow-up. Ninety-nine participants, aged 24 to 64 years, with pain for a minimum of 3 months, were recruited from community-based clinics, hospitals, and community service centers. Participants were randomly allocated to either the MBSR program (51 participants) or a MPI program (48 participants). The study used validated Chinese versions of self-reported questionnaires measuring pain, mood symptoms, and health-related quality of life. Thirty-nine participants (77%) completed the MBSR program and 44 (90%) completed the MPI program. Patients in both the groups were comparable with regard to demographical characteristics, pain intensity, mood symptoms, and health-related quality-of-life measures before intervention. In both the groups, patients who completed the trial demonstrated statistically significant improvements in pain intensity and pain-related distress. However, no statistically significant differences were observed in overall results between the MBSR and MPI groups. This randomized, clinical trial showed that both MBSR and MPI programs reduced pain intensity and pain-related distress although no statistically significant differences were observed between the 2 groups and the improvements were small.

  6. A randomized trial comparing levothyroxine with radioactive iodine in the treatment of sporadic nontoxic goiter

    NARCIS (Netherlands)

    Wesche, M. F.; Tiel-V Buul, M. M.; Lips, P.; Smits, N. J.; Wiersinga, W. M.

    2001-01-01

    A randomized clinical trial was performed in consecutive patients with sporadic nontoxic nodular goiter to compare efficacy and side effects of iodine-131 ((131)I) therapy with suppressive levothyroxine (L-thyroxine) treatment. Sixty-four patients were randomized after stratification for sex and

  7. Real-life COPD patients compared to large trial populations : An UNLOCK external validity study

    NARCIS (Netherlands)

    Kruis, Annemarije; Ställberg, Bjorn; Jones, Rupert; Tsiligianni, Ioanna; Kocks, Jan Willem; Van Der Molen, Thys; Chavannes, Niels

    2013-01-01

    Objective To investigate the external validity of six large randomized controlled medication trials (ISOLDE, TRISTAN, TORCH, UPLIFT, ECLIPSE, POET-COPD) compared to the COPD population seen in the community, and to examine the proportion of patients in the community that would be selected based on

  8. Comparing surgical repair with conservative treatment for degenerative rotator cuff tears : a randomized controlled trial

    NARCIS (Netherlands)

    Lambers Heerspink, Okke; van Raay, Jos J. A. M.; Koorevaar, Rinco C. T.; van Eerden, Pepijn J. M.; Westerbeek, Robin E.; van 't Riet, Esther; van den Akker-Scheek, Inge; Diercks, Ronald L.

    Background: Good clinical results have been reported for both surgical and conservative treatment of rotator cuff tears. The primary aim of this randomized controlled trial was to compare functional and radiologic improvement after surgical and conservative treatment of degenerative rotator cuff

  9. Albendazole versus praziquantel in the treatment of neurocysticercosis: a meta-analysis of comparative trials.

    Directory of Open Access Journals (Sweden)

    Dimitrios K Matthaiou

    Full Text Available BACKGROUND: Neurocysticercosis, infection of the brain with larvae of Taenia solium (pork tapeworm, is one of several forms of human cysticercosis caused by this organism. We investigated the role of albendazole and praziquantel in the treatment of patients with parenchymal neurocysticercosis by performing a meta-analysis of comparative trials of their effectiveness and safety. METHODS AND PRINCIPAL FINDINGS: We performed a search in the PubMed database, Cochrane Database of Controlled Trials, and in references of relevant articles. Six studies were included in the meta-analysis. Albendazole was associated with better control of seizures than praziquantel in the pooled data analysis, when the generic inverse variance method was used to combine the incidence of seizure control in the included trials (patients without seizures/[patients x years at risk] (156 patients in 4 studies, point effect estimate [incidence rate ratio] = 4.94, 95% confidence interval 2.45-9.98. In addition, albendazole was associated with better effectiveness than praziquantel in the total disappearance of cysts (335 patients in 6 studies, random effects model, OR = 2.30, 95% CI 1.06-5.00. There was no difference between albendazole and praziquantel in reduction of cysts, proportion of patients with adverse events, and development of intracranial hypertension due to the administered therapy. CONCLUSIONS: A critical review of the available data from comparative trials suggests that albendazole is more effective than praziquantel regarding clinically important outcomes in patients with neurocysticercosis. Nevertheless, given the relative scarcity of trials, more comparative interventional studies--especially randomized controlled trials--are required to draw a safe conclusion about the best regimen for the treatment of patients with parenchymal neurocysticercosis.

  10. Active-control trials: how would a new agent compare with placebo? A method illustrated with clopidogrel, aspirin, and placebo

    NARCIS (Netherlands)

    Fisher, L. D.; Gent, M.; Büller, H. R.

    2001-01-01

    In an active-control trial with a new treatment and a comparator that has placebo-controlled trials, how might the effect of the new therapy versus placebo be estimated? For many diseases it is not ethically justified to use a placebo-control trial, yet in the United States regulatory efficacy is

  11. Comparative effectiveness of initial antiretroviral therapy regimens: ACTG 5095 and 5142 clinical trials relative to ART-CC cohort study

    NARCIS (Netherlands)

    Mugavero, Michael J.; May, Margaret; Ribaudo, Heather J.; Gulick, Roy M.; Riddler, Sharon A.; Haubrich, Richard; Napravnik, Sonia; Abgrall, Sophie; Phillips, Andrew; Harris, Ross; Gill, M. John; de Wolf, Frank; Hogg, Robert; Günthard, Huldrych F.; Chêne, Geneviève; D'Arminio Monforte, Antonella; Guest, Jodie L.; Smith, Colette; Murillas, Javier; Berenguer, Juan; Wyen, Christoph; Domingo, Pere; Kitahata, Mari M.; Sterne, Jonathan A. C.; Saag, Michael S.; Shikuma, Cecilia M.; Ribaudo, Heather; Lalama, Christina; Klingman, Karin K.; Bastow, Barbara; Kmack, Anne; Meyer, William A.; Kutitzkes, Daniel R.; Acosta, Edward P.; Hughes, Valery; Squires, Kathleen E.; Shackman, Bruce R.; Schouten, Jeffrey T.; Parrillo, Vincent; Martinez, Ana I.; Fallis, Richard; Storfer, Stephen P.; Giordano, Michael; McDonough, Marita; Rooney, James; Rugh, Lynn; Ryan, Kirk; Tolson, Jerry; van Kempen, Amy S.; Schnizlein Bick, Carol; Webb, Nancy; DiRienzo, A. Gregory; Peeples, Lynne; Powderly, William G.; Klingman, Karin L.; Garren, Kevin W.; George, Tania; Rooney, James F.; Brizz, Barbara; Lalloo, Umesh G.; Murphy, Robert L.; Swindells, Susan; Havlir, Diane; Mellors, John W.

    2011-01-01

    The generalizability of antiretroviral therapy (ART) clinical trial efficacy findings to routine care settings is not well studied. We compared the relative effectiveness of initial ART regimens estimated in AIDS Clinical Trial Group (ACTG) randomized controlled trials with that among patients

  12. Rosemary oil vs minoxidil 2% for the treatment of androgenetic alopecia: a randomized comparative trial.

    Science.gov (United States)

    Panahi, Yunes; Taghizadeh, Mohsen; Marzony, Eisa Tahmasbpour; Sahebkar, Amirhossein

    2015-01-01

    Rosmarinus officinalis L. is a medicinal plant with diverse activities including enhancement microcapillary perfusion. The present study aimed to investigate the clinical efficacy of rosemary oil in the treatment of androgenetic alopecia (AGA) and compare its effects with minoxidil 2%. Patients with AGA were randomly assigned to rosemary oil (n = 50) or minoxidil 2% (n = 50) for a period of 6 months. After a baseline visit, patients returned to the clinic for efficacy and safety evaluations every 3 months. A standardized professional microphotographic assessment of each volunteer was taken at the initial interview and after 3 and 6 months of the trial. No significant change was observed in the mean hair count at the 3-month endpoint, neither in the rosemary nor in the minoxidil group (P > .05). In contrast, both groups experienced a significant increase in hair count at the 6-month endpoint compared with the baseline and 3-month endpoint (P .05). The frequencies of dry hair, greasy hair, and dandruff were not found to be significantly different from baseline at either month 3 or month 6 trial in the groups (P > .05). The frequency of scalp itching at the 3- and 6-month trial points was significantly higher compared with baseline in both groups (P minoxidil group at both assessed endpoints (P < .05). The findings of the present trial provided evidence with respect to the efficacy of rosemary oil in the treatment of AGA.

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

    DEFF Research Database (Denmark)

    Zarchi, K.; Jemec, G.B.

    2012-01-01

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

  14. A randomized crossover trial of tenoxicam compared with rofecoxib for postoperative dental pain control.

    Science.gov (United States)

    Zacharias, M; De Silva, R K; Herbison, P; Templer, P

    2004-12-01

    Two non-steroidal anti-inflammatory drugs, tenoxicam and rofecoxib, were compared for the control of postoperative pain following surgical extraction of bilaterally and symmetrically impacted wisdom teeth performed under intravenous sedation and local anaesthesia. Thirty-five young fit adult patients received each analgesic treatment for four days in a randomized, crossover design. The results suggest statistically better pain relief for the selective COX-2 inhibitor rofecoxib compared to tenoxicam, a traditional NSAID. There were side-effects with both treatments. Abdominal discomfort was significantly more common following rofecoxib compared to tenoxicam. Both analgesics were acceptable to most participants in the trial.

  15. A comparative analysis of quality management standards for contract research organisations in clinical trials.

    Science.gov (United States)

    Murray, Elizabeth; McAdam, Rodney

    2007-01-01

    This article compares and contrasts the main quality standards in the highly regulated pharmaceutical industry with specific focus on Good Clinical Practice (GCP), the standard for designing, conducting, recording and reporting clinical trials involving human participants. Comparison is made to ISO quality standards, which can be applied to all industries and types of organisation. The study is then narrowed to that of contract research organisations (CROs) involved in the conduct of clinical trials. The paper concludes that the ISO 9000 series of quality standards can act as a company-wide framework for quality management within such organisations by helping to direct quality efforts on a long-term basis without any loss of compliance. This study is valuable because comparative analysis in this domain is uncommon.

  16. Treatment of stress urinary incontinence after prostatectomy with the adjustable transobturator male system (ATOMS®) with preattached scrotal port.

    Science.gov (United States)

    Esquinas, C; Arance, I; Pamplona, J; Moraga, A; Dorado, J F; Angulo, J C

    2018-04-08

    Stress urinary incontinence (SUI) is a significant sequela of prostate cancer surgery. In this article, we present the surgical technique and safety and efficacy of the adjustable transobturator male system (ATOMS®) with preattached scrotal port. An open prospective study was conducted at a university hospital with the main objective of changing the baseline condition after adjustment in the daily pad count and their wet weight (pad test). The secondary objectives were the quality-of-life assessment (International Consultation on Incontinence Questionnaire-Short Form [ICIQ-SF] and Incontinence Impact Questionnaire-7 [IIQ-7], baseline and after the adjustment), patient-perceived results (Patient Global Index [PGI] and Global Response Assessment [GRA] at 1 year) and assessment of complications according to Clavien-Dindo. The numerical values are expressed in median ± IQR. We analysed 60 consecutive patients with a follow-up of 21±22 months. The baseline pad-test was 465±450mL, and the pad-count was 5+3 pads/day. The baseline SUI was mild (11.6% of patients), moderate (25%) and severe (63.3%). The operative time was 60±25min, the hospital stay was 1±0 days, and the visual analogue scale of pain on day 1 after surgery was 0±1. The total filling was 16.5±7mL, and the number of refillings was 1±2. The pad-test and pad-count after the adjustment were 0±20mL and 0±1, respectively (both pATOMS® is safe and effective in the short-term, even in patients with severe SUI. The rate of dry patients after the adjustment exceeded 80%, and the satisfaction rates exceeded 90%. The patients assessed this treatment highly positively. Copyright © 2018 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

  17. Comparative efficacy of aloe vera mouthwash and chlorhexidine on periodontal health: A randomized controlled trial

    OpenAIRE

    Vangipuram, Swathi; Jha, Abhishek; Bhashyam, Mamtha

    2016-01-01

    Background With introduction of many herbal medicines, dentistry has recently evidenced shift of approach for treating many inflammatory oral diseases by using such modalities. Aloe vera is one such product exhibiting multiple benefits and has gained considerable importance in clinical research recently. Aim To compare the efficacy of Aloevera and Chlorhexidine mouthwash on Periodontal Health. Material and Methods Thirty days randomized controlled trial was conducted among 390 dental students...

  18. A randomized trial comparing levo-alpha acetylmethadol with methadone maintenance for patients in primary care settings in Australia

    NARCIS (Netherlands)

    Ritter, AJ; Lintzeris, N; Clark, N; Kutin, JJ; Bammer, G; Panjari, M

    2003-01-01

    Aims The present study aimed to compare the efficacy of levo-alpha-acetylmethadol (LAAM) and methadone, as measured by retention in treatment and heroin use, in a randomized trial conducted under naturalistic conditions. Setting This study is the first randomized trial comparing LAAM with methadone

  19. How Often Do Comparative Randomised Controlled Trials in the Field of Eczema Fail to Directly Compare the Treatments Being Tested?

    Directory of Open Access Journals (Sweden)

    Sonia Ratib

    2015-06-01

    Full Text Available The objective of the study was to identify all parallel design randomised controlled trials (RCTs comparing treatments for eczema in recent dermatology literature that have failed to report a between-group analysis. The GREAT database (www.greatdatabase.org.uk was searched to identify parallel group RCTs comparing two or more interventions published in the English language in the last decade, 2004 to 2013. The primary outcome was the number of studies that had not reported a between-group analysis for any of the outcomes. Where possible we re-analysed the data to determine whether a between-group analysis would have given a different conclusion to that reported. Out of a total of 304 RCTs in the study period, 173 (56.9% met the inclusion criteria. Of the 173 eligible studies, 12 (6.9% had not conducted a between-group analysis for any of the reported outcomes. There was no clear improvement over time. Five of the eight studies that were re-analysed yielded non-significant between-group differences yet reported significant within-group comparisons. All but one of the 12 studies implied that the experimental intervention was successful despite not undertaking any between-group comparisons. Although the proportion of all RCTs that fail to report an appropriate between-group analysis is small, the fact that any scientist who purports to compare one treatment against another then chooses to omit the key comparison statistic is worrying.

  20. A randomized comparative trial of the Lippes Loop D, Gravigard and TCu 220C IUDs.

    Science.gov (United States)

    Mccarthy, T G; Lim, L S; Chew, S C; Heng, S H; Ratnam, S S

    1985-01-01

    This randomized prospective trial compared the use-effectiveness and pregnancy rates in 3 IUDs following immediate postabortal insertion in 199 women over 3107 months of use. At 24 months the Gravgard (Cu 7) was not significantly different from either of the other 2 devices. However, the Lippes Loop D when compared with the TCu 220C had a higher expulsion rate (P less than 0.05) and a higher use-related termination rate (P less than 0.001). Further details of accidental pregnancies, removal for incomplete abortion or pelvic inflammatory disease and within 48 hours after insertion are presented.

  1. Comparative efficacy trial of cupping and serkangabin versus conventional therapy of migraine headaches: A randomized, open-label, comparative efficacy trial.

    Science.gov (United States)

    Firoozabadi, Mohammad Dehghani; Navabzadeh, Maryam; Roudsari, Mohammad Khodashenas; Zahmatkash, Mohsen

    2014-12-01

    Migraine headaches are the most common acute and recurrent headaches. Current treatment of a migraine headache consists of multiple medications for control and prevention of recurrent attacks. Global emergence of alternative medicine led us to examine the efficacy of cupping therapy plus serkangabin syrup in the treatment of migraine headaches. This study was a randomized, controlled, open-label, comparative efficacy trial. We randomly assigned patients with migraine into cupping therapy plus serkangabin group (30 patients) and conventional treatment group (30 patients). An investigator assessed the severity of headache, frequency of attacks in a week and duration of attacks per hour in 5 visits (at the end of 2 weeks, 1, 3 and 6 months). Generalized estimating equations approach was used to analyze repeated measures data to compare outcomes in both groups. Average age for cupping therapy group and conventional treatment group were 31.7 (±7.6) and 32.6 (±12.7) years, respectively (P = 0.45). After treatment for 2 weeks; and 1, 3 and 6 months, severity of headache (P = 0.80), frequency of migraine attacks (P = 0.63) and duration of attacks per hours (P = 0.48) were similar in conventional and cupping groups but these symptoms were decreased in each group during the study (P cupping plus serkangabin therapy and conventional treatment in the treatment and prophylaxis of migraine. The alternative therapy may be used in cases of drug intolerance, no medication response, and in primary care.

  2. Design, recruitment outcomes, and sample characteristics of the Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial.

    Science.gov (United States)

    Krebs, Erin E; Jensen, Agnes C; Nugent, Sean; DeRonne, Beth; Rutks, Indulis; Leverty, David; Gravely, Amy; Noorbaloochi, Siamak; Bair, Matthew J; Kroenke, Kurt

    2017-11-01

    This manuscript describes the study protocol, recruitment outcomes, and baseline participant characteristics for the Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial. SPACE is a pragmatic randomized comparative effectiveness trial conducted in multiple VA primary care clinics within one VA health care system. The objective was to compare benefits and harms of opioid therapy versus non-opioid medication therapy over 12months among patients with moderate-to-severe chronic back pain or hip/knee osteoarthritis pain despite analgesic therapy; patients already receiving regular opioid therapy were excluded. Key design features include comparing two clinically-relevant medication interventions, pragmatic eligibility criteria, and flexible treat-to-target interventions. Screening, recruitment and study enrollment were conducted over 31months. A total of 4491 patients were contacted for eligibility screening; 53.1% were ineligible, 41.0% refused, and 5.9% enrolled. The most common reasons for ineligibility were not meeting pain location and severity criteria. The most common study-specific reasons for refusal were preference for no opioid use and preference for no pain medications. Of 265 enrolled patients, 25 withdrew before randomization. Of 240 randomized patients, 87.9% were male, 84.1% were white, and age range was 21-80years. Past-year mental health diagnoses were 28.3% depression, 17% anxiety, 9.4% PTSD, 7.9% alcohol use disorder, and 2.6% drug use disorder. In conclusion, although recruitment for this trial was challenging, characteristics of enrolled participants suggest we were successful in recruiting patients similar to those prescribed opioid therapy in usual care. Published by Elsevier Inc.

  3. Plaque removal efficacy of oscillating-rotating power toothbrushes: review of six comparative clinical trials.

    Science.gov (United States)

    Grender, Julie; Williams, Karen; Walters, Pat; Klukowska, Malgorzata; Reick, Hansjoerg

    2013-04-01

    This review of six clinical trials provides a comprehensive overview of the results of statistical analyses to explore between-brush differences, specifically in the lingual, gingival marginal, and approximal ("hard-to-clean") areas, in post-brushing plaque removal of oscillating-rotating (O-R) power toothbrushes compared to either a marketed sonic power toothbrush or a manual toothbrush control. All studies were single-center, randomized and controlled, and examiner-blind. Four trials were four-period crossover design with replicate single-use brushing, while two studies were parallel group investigations (4 or 12 weeks) with multiple brushings and assessments at each visit. Generally healthy subjects were enrolled. Plaque evaluations were via the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) or the Rustogi Modification of the Navy Plaque Index (RMNPI). At each evaluation visit, subjects brushed with either the randomly assigned O-R power brush [Oral-B Professional Care Series 4000 (Triumph) or Oral-B Vitality with Floss Action or Precision Clean brush head] or a control brush [Sonicare FlexCare with ProResults brush head (three trials) or an American Dental Association (ADA) reference manual toothbrush (three trials)]. ANCOVA and ANOVA analyses subsequently evaluated specifically the 'hard-to-clean' tooth surfaces for between-brush differences. In total, 462 subjects completed the trials and were evaluable. While all toothbrushes provided significant post-brushing versus baseline plaque removal efficacy, the magnitude of the reduction was consistently superior for the O-R brush compared to either the sonic power or manual brush control in all the 'hard-to-clean" region-specific analyses. Adjusted mean RMNPI or TMQHPI benefits favoring the O-R brush relative to the sonic brush control were collectively 18% to 34% greater on lingual surfaces (P benefits favoring the O-R brush compared to the manual brush control were collectively 31% to 206

  4. Comparative efficacy trial of cupping and serkangabin versus conventional therapy of migraine headaches: A randomized, open-label, comparative efficacy trial

    Directory of Open Access Journals (Sweden)

    Mohammad Dehghani Firoozabadi

    2014-01-01

    Full Text Available Background: Migraine headaches are the most common acute and recurrent headaches. Current treatment of a migraine headache consists of multiple medications for control and prevention of recurrent attacks. Global emergence of alternative medicine led us to examine the efficacy of cupping therapy plus serkangabin syrup in the treatment of migraine headaches. Materials and Methods: This study was a randomized, controlled, open-label, comparative efficacy trial. We randomly assigned patients with migraine into cupping therapy plus serkangabin group (30 patients and conventional treatment group (30 patients. An investigator assessed the severity of headache, frequency of attacks in a week and duration of attacks per hour in 5 visits (at the end of 2 weeks, 1, 3 and 6 months. Generalized estimating equations approach was used to analyze repeated measures data to compare outcomes in both groups. Results: Average age for cupping therapy group and conventional treatment group were 31.7 (±7.6 and 32.6 (±12.7 years, respectively (P = 0.45. After treatment for 2 weeks; and 1, 3 and 6 months, severity of headache (P = 0.80, frequency of migraine attacks (P = 0.63 and duration of attacks per hours (P = 0.48 were similar in conventional and cupping groups but these symptoms were decreased in each group during the study (P < 0.001. Conclusion: There was no significant difference between cupping plus serkangabin therapy and conventional treatment in the treatment and prophylaxis of migraine. The alternative therapy may be used in cases of drug intolerance, no medication response, and in primary care.

  5. Iohexol and iopamidol myelography in the dog: a clinical trial comparing adverse effects and myelographic quality

    International Nuclear Information System (INIS)

    Widmer, W.R.; Blevins, W.E.; Jakovljevic, S.; Teclaw, R.F.; Han, C.M.; Hurd, C.D.

    1992-01-01

    In a blind clinical trial, adverse effects after iohexol and iopamidol myelography were evaluated in 151 dogs. Eighty-one dogs were given iohexol (240 mgI/ml) and 70 dogs were given iopamidol (200 mgI/ml) by pre-determined assignment. Each dog was evaluated postmyelographically for seizures, hyperthermia, prolonged recovery from anesthesia and intensification of pre-existing neural signs. Myelographic quality was evaluated with a subjective scoring method. In comparing iohexol and iopamidol groups, there was not a statistically significant difference in the incidence of adverse effects or in myelographic quality. Iopamidol and iohexol appeared to be equally efficacious for routine canine myelography

  6. Internet treatment for depression: a randomized controlled trial comparing clinician vs. technician assistance.

    Directory of Open Access Journals (Sweden)

    Nickolai Titov

    Full Text Available BACKGROUND: Internet-based cognitive behavioural therapy (iCBT for depression is effective when guided by a clinician, less so if unguided. QUESTION: Would guidance from a technician be as effective as guidance from a clinician? METHOD: Randomized controlled non-inferiority trial comparing three groups: Clinician-assisted vs. technician-assisted vs. delayed treatment. Community-based volunteers applied to the VirtualClinic (www.virtualclinic.org.au research program, and 141 participants with major depressive disorder were randomized. Participants in the clinician- and technician-assisted groups received access to an iCBT program for depression comprising 6 online lessons, weekly homework assignments, and weekly supportive contact over a treatment period of 8 weeks. Participants in the clinician-assisted group also received access to a moderated online discussion forum. The main outcome measures were the Beck Depression Inventory (BDI-II and the Patient Health QUESTIONnaire-9 Item (PHQ-9. Completion rates were high, and at post-treatment, both treatment groups reduced scores on the BDI-II (p<0.001 and PHQ-9 (p<0.001 compared to the delayed treatment group but did not differ from each other. Within group effect sizes on the BDI-II were 1.27 and 1.20 for the clinician- and technician-assisted groups respectively, and on the PHQ-9, were 1.54 and 1.60 respectively. At 4-month follow-up participants in the technician group had made further improvements and had significantly lower scores on the PHQ-9 than those in the clinician group. A total of approximately 60 minutes of clinician or technician time was required per participant during the 8-week treatment program. CONCLUSIONS: Both clinician- and technician-assisted treatment resulted in large effect sizes and clinically significant improvements comparable to those associated with face-to-face treatment, while a delayed treatment control group did not improve. These results provide support for large

  7. Integrating tobacco treatment into cancer care: Study protocol for a randomized controlled comparative effectiveness trial.

    Science.gov (United States)

    Park, Elyse R; Ostroff, Jamie S; Perez, Giselle K; Hyland, Kelly A; Rigotti, Nancy A; Borderud, Sarah; Regan, Susan; Muzikansky, Alona; Friedman, Emily R; Levy, Douglas E; Holland, Susan; Eusebio, Justin; Peterson, Lisa; Rabin, Julia; Miller-Sobel, Jacob; Gonzalez, Irina; Malloy, Laura; O'Brien, Maureen; de León-Sanchez, Suhana; Whitlock, C Will

    2016-09-01

    Despite the well-established risks of persistent smoking, 10-30% of cancer patients continue to smoke after diagnosis. Evidence-based tobacco treatment has yet to be integrated into routine oncology care. This paper describes the protocol, manualized treatment, evaluation plan, and overall study design of comparing the effectiveness and cost of two treatments across two major cancer centers. A two-arm, two-site randomized controlled comparative effectiveness trial is testing the hypothesis that an Intensive Treatment (IT) intervention is more effective than a Standard Treatment (ST) intervention in helping recently diagnosed cancer patients quit smoking. Both interventions include 4 weekly counseling sessions and FDA-approved smoking cessation medication advice. The IT includes an additional 4 biweekly and 3 monthly booster sessions as well as dispensal of the recommended FDA-approved smoking cessation medication at no cost. The trial is enrolling patients with suspected or newly diagnosed cancer who have smoked a cigarette in the past 30days. Participants are randomly assigned to receive the ST or IT condition. Tobacco cessation outcomes are assessed at 3 and 6months. The primary study outcome is 7-day point prevalence biochemically-validated tobacco abstinence. Secondary study outcomes include the incremental cost-effectiveness of the IT vs. ST. This trial will answer key questions about delivering tobacco treatment interventions to newly diagnosed cancer patients. If found to be efficacious and cost-effective, this treatment will serve as a model to be integrated into oncology care settings nation-wide, as we strive to improve treatment outcomes and quality of life for cancer patients. Copyright © 2016. Published by Elsevier Inc.

  8. The effects of Red Bull energy drink compared with caffeine on cycling time-trial performance.

    Science.gov (United States)

    Quinlivan, Alannah; Irwin, Christopher; Grant, Gary D; Anoopkumar-Dukie, Sheilandra; Skinner, Tina; Leveritt, Michael; Desbrow, Ben

    2015-10-01

    This study investigated the ergogenic effects of a commercial energy drink (Red Bull) or an equivalent dose of anhydrous caffeine in comparison with a noncaffeinated control beverage on cycling performance. Eleven trained male cyclists (31.7 ± 5.9 y 82.3 ± 6.1 kg, VO2max = 60.3 ± 7.8 mL · kg-1 · min-1) participated in a double-blind, placebo-controlled, crossover-design study involving 3 experimental conditions. Participants were randomly administered Red Bull (9.4 mL/kg body mass [BM] containing 3 mg/kg BM caffeine), anhydrous caffeine (3 mg/kg BM given in capsule form), or a placebo 90 min before commencing a time trial equivalent to 1 h cycling at 75% peak power output. Carbohydrate and fluid volumes were matched across all trials. Performance improved by 109 ± 153 s (2.8%, P = .039) after Red Bull compared with placebo and by 120 ± 172 s (3.1%, P = .043) after caffeine compared with placebo. No significant difference (P > .05) in performance time was detected between Red Bull and caffeine treatments. There was no significant difference (P > .05) in mean heart rate or rating of perceived exertion among the 3 treatments. This study demonstrated that a moderate dose of caffeine consumed as either Red Bull or in anhydrous form enhanced cycling time-trial performance. The ergogenic benefits of Red Bull energy drink are therefore most likely due to the effects of caffeine, with the other ingredients not likely to offer additional benefit.

  9. Comparing methods to combine functional loss and mortality in clinical trials for amyotrophic lateral sclerosis

    Directory of Open Access Journals (Sweden)

    van Eijk RPA

    2018-03-01

    Full Text Available Ruben PA van Eijk,1 Marinus JC Eijkemans,2 Dimitris Rizopoulos,3 Leonard H van den Berg,4,* Stavros Nikolakopoulos5,* 1Department of Neurology, University Medical Center Utrecht, Utrecht, the Netherlands; 2Department of Biostatistics, University Medical Center Utrecht, Utrecht, the Netherlands; 3Department of Biostatistics, Erasmus University Medical Center, Rotterdam, the Netherlands; 4Department of Neurology, University Medical Center Utrecht, Utrecht, the Netherlands; 5Department of Biostatistics, University Medical Center Utrecht, Utrecht, the Netherlands *These authors contributed equally to this work Objective: Amyotrophic lateral sclerosis (ALS clinical trials based on single end points only partially capture the full treatment effect when both function and mortality are affected, and may falsely dismiss efficacious drugs as futile. We aimed to investigate the statistical properties of several strategies for the simultaneous analysis of function and mortality in ALS clinical trials. Methods: Based on the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT database, we simulated longitudinal patterns of functional decline, defined by the revised amyotrophic lateral sclerosis functional rating scale (ALSFRS-R and conditional survival time. Different treatment scenarios with varying effect sizes were simulated with follow-up ranging from 12 to 18 months. We considered the following analytical strategies: 1 Cox model; 2 linear mixed effects (LME model; 3 omnibus test based on Cox and LME models; 4 composite time-to-6-point decrease or death; 5 combined assessment of function and survival (CAFS; and 6 test based on joint modeling framework. For each analytical strategy, we calculated the empirical power and sample size. Results: Both Cox and LME models have increased false-negative rates when treatment exclusively affects either function or survival. The joint model has superior power compared to other strategies. The composite end point

  10. Ondansetron compared with metoclopramide for hyperemesis gravidarum: a randomized controlled trial.

    Science.gov (United States)

    Abas, Mohamed Norazam; Tan, Peng Chiong; Azmi, Noor; Omar, Siti Zawiah

    2014-06-01

    To compare ondansetron with metoclopramide in the treatment of hyperemesis gravidarum. We enrolled 160 women with hyperemesis gravidarum in a double-blind randomized trial. Participants were randomized to intravenous 4 mg ondansetron or 10 mg metoclopramide every 8 hours for 24 hours. Participants kept an emesis diary for 24 hours; at 24 hours, they expressed their well-being using a 10-point visual numeric rating scale and answered an adverse effects questionnaire. Nausea intensity was evaluated using a 10-point visual numeric rating scale at enrollment and at 8, 16, and 24 hours. Primary analysis was on an intention-to-treat basis. Eighty women each were randomized to ondansetron or metoclopramide. Median well-being visual numeric rating scale scores were 9 (range, 5-10) compared with 9 (range, 4-10) (P=.33) and vomiting episodes in the first 24 hours were 1 (range, 0-9) compared with 2 (range, 0-23) (P=.38) for ondansetron compared with metoclopramide, respectively. Repeat-measures analysis of variance of nausea visual numeric rating scale showed no difference between study drugs (P=.22). Reported rates of drowsiness (12.5% compared with 30%; P=.01; number needed to treat to benefit, 6), xerostomia (10.0% compared with 23.8%; Phyperemesis gravidarum. However, the overall profile, particularly regarding adverse effects, was better with ondansetron. In our setting, metoclopramide was significantly less expensive than ondansetron and remained a reasonable antiemetic choice. ISRCN Register, www.isrctn.org, ISRCTN00592566. I.

  11. Behavioral Effects of Neurofeedback Compared to Stimulants and Physical Activity in Attention-Deficit/Hyperactivity Disorder: A Randomized Controlled Trial

    NARCIS (Netherlands)

    Geladé, Katleen; Janssen, Tieme W. P.; Bink, Marleen; van Mourik, Rosa; Maras, Athanasios; Oosterlaan, Jaap

    2016-01-01

    The efficacy of neurofeedback as a treatment for attention-deficit/hyperactivity disorder (ADHD), and whether neurofeedback is a viable alternative for stimulant medication, is still an intensely debated subject. The current randomized controlled trial compared neurofeedback to (1) optimally

  12. Behavioral Effects of Neurofeedback Compared to Stimulants and Physical Activity in Attention-Deficit/Hyperactivity Disorder: A Randomized Controlled Trial

    NARCIS (Netherlands)

    Gelade, K.; Janssen, T.W.P.; Bink, M.; van Mourik, R.; Maras, A.; Oosterlaan, J.

    2016-01-01

    Objective: The efficacy of neurofeedback as treatment for attention-deficit/hyperactivity disorder (ADHD), and whether neurofeedback is a viable alternative for stimulant medication, are still intensely debated subjects. The current randomised controlled trial compared neurofeedback to (1) optimally

  13. The IDvIP Trial: A two-centre randomised double-blind controlled trial comparing intramuscular diamorphine and intramuscular pethidine for labour analgesia

    Directory of Open Access Journals (Sweden)

    Thomas Peter

    2011-07-01

    Full Text Available Abstract Background Intramuscular pethidine is routinely used throughout the UK for labour analgesia. Studies have suggested that pethidine provides little pain relief in labour and has a number of side effects affecting mother and neonate. It can cause nausea, vomiting and dysphoria in mothers and can cause reduced fetal heart rate variability and accelerations. Neonatal effects include respiratory depression and impaired feeding. There are few large studies comparing the relative side effects and efficacy of different opioids in labour. A small trial comparing intramuscular pethidine with diamorphine, showed diamorphine to have some benefits over pethidine when used for labour analgesia but the study did not investigate the adverse effects of either opioid. Methods The Intramuscular Diamorphine versus Intramuscular Pethidine (IDvIP trial is a randomised double-blind two centre controlled trial comparing intramuscular diamorphine and pethidine regarding their analgesic efficacy in labour and their side effects in mother, fetus and neonate. Information about the trial will be provided to women in the antenatal period or in early labour. Consent and recruitment to the trial will be obtained when the mother requests opioid analgesia. The sample size requirement is 406 women with data on primary outcomes. The maternal primary outcomes are pain relief during the first 3 hours after trial analgesia and specifically pain relief after 60 minutes. The neonatal primary outcomes are need for resuscitation and Apgar Score Discussion If the trial demonstrates that diamorphine provides better analgesia with fewer side effects in mother and neonate this could lead to a change in national practice and result in diamorphine becoming the preferred intramuscular opioid for analgesia in labour. Trial Registration ISRCTN14898678 Eudra No: 2006-003250-18, REC Reference No: 06/Q1702/95, MHRA Authorisation No: 1443/0001/001-0001, NIHR UKCRN reference 6895, RfPB grant

  14. Stereotactically-navigated percutaneous Irreversible Electroporation (IRE compared to conventional IRE: a prospective trial

    Directory of Open Access Journals (Sweden)

    Lukas P. Beyer

    2016-08-01

    Full Text Available Purpose. The purpose of this study was to compare CT-navigated stereotactic IRE (SIRE needle placement to non-navigated conventional IRE (CIRE for percutaneous ablation of liver malignancies. Materials and Methods. A prospective trial including a total of 20 patients was conducted with 10 patients in each arm of the study. IRE procedures were guided using either CT fluoroscopy (CIRE or a stereotactic planning and navigation system (SIRE. Primary endpoint was procedure time. Secondary endpoints were accuracy of needle placement, technical success rate, complication rate and dose-length product (DLP. Results. A total of 20 IRE procedures were performed to ablate hepatic malignancies (16 HCC, 4 liver metastases, 10 procedures in each arm. Mean time for placement of IRE electrodes in SIRE was significantly shorter with 27 ± 8 min compared to 87 ± 30 min for CIRE (p < 0.001. Accuracy of needle placement for SIRE was higher than CIRE (2.2 mm vs. 3.3 mm mean deviation, p < 0.001. The total DLP and the fluoroscopy DLP were significantly lower in SIRE compared to CIRE. Technical success rate and complication rates were equal in both arms. Conclusion. SIRE demonstrated a significant reduction of procedure length and higher accuracy compared to CIRE. Stereotactic navigation has the potential to reduce radiation dose for the patient and the radiologist without increasing the risk of complications or impaired technical success compared to CIRE.

  15. FLOW (finding lasting options for women): multicentre randomized controlled trial comparing tampons with menstrual cups.

    Science.gov (United States)

    Howard, Courtney; Rose, Caren Lee; Trouton, Konia; Stamm, Holly; Marentette, Danielle; Kirkpatrick, Nicole; Karalic, Sanja; Fernandez, Renee; Paget, Julie

    2011-06-01

    To determine whether menstrual cups are a viable alternative to tampons. Randomized controlled trial. Prince George, Victoria, and Vancouver, BC. A total of 110 women aged 19 to 40 years who had previously used tampons as their main method of menstrual management. Participants were randomized into 2 groups, a tampon group and a menstrual cup group. Using online diaries, participants tracked 1 menstrual cycle using their regular method and 3 menstrual cycles using the method of their allocated group. Overall satisfaction; secondary outcomes included discomfort, urovaginal infection, cost, and waste. Forty-seven women in each group completed the final survey, 5 of whom were subsequently excluded from analysis (3 from the tampon group and 2 from the menstrual cup group). Overall satisfaction on a 7-point Likert scale was higher for the menstrual cup group than for the tampon group (mean [standard deviation] score 5.4 [1.5] vs 5.0 [1.0], respectively; P=.04). Approximately 91% of women in the menstrual cup group said they would continue to use the cup and recommend it to others. Women used a median of 13 menstrual products per cycle, or 169 products per year, which corresponds to approximately 771,248,400 products used annually in Canada. Estimated cost for tampon use was $37.44 a year (similar to the retail cost of 1 menstrual cup). Subjective vaginal discomfort was initially higher in the menstrual cup group, but the discomfort decreased with continued use. There was no significant difference in physician-diagnosed urovaginal symptoms between the 2 groups. Both of the menstrual management methods evaluated were well tolerated by subjects. Menstrual cups are a satisfactory alternative to tampons and have the potential to be a sustainable solution to menstrual management, with moderate cost savings and much-reduced environmental effects compared with tampons. Trial registration number C06-0478 (ClinicalTrials.gov).

  16. A Randomized Trial Comparing Two Tongue-Pressure Resistance Training Protocols for Post-Stroke Dysphagia.

    Science.gov (United States)

    Steele, Catriona M; Bayley, Mark T; Peladeau-Pigeon, Melanie; Nagy, Ahmed; Namasivayam, Ashwini M; Stokely, Shauna L; Wolkin, Talia

    2016-06-01

    The objective of this study was to compare the outcomes of two tongue resistance training protocols. One protocol ("tongue-pressure profile training") emphasized the pressure-timing patterns that are typically seen in healthy swallows by focusing on gradual pressure release and saliva swallowing tasks. The second protocol ("tongue-pressure strength and accuracy training") emphasized strength and accuracy in tongue-palate pressure generation and did not include swallowing tasks. A prospective, randomized, parallel allocation trial was conducted. Of 26 participants who were screened for eligibility, 14 received up to 24 sessions of treatment. Outcome measures of posterior tongue strength, oral bolus control, penetration-aspiration and vallecular residue were made based on videofluoroscopy analysis by blinded raters. Complete data were available for 11 participants. Significant improvements were seen in tongue strength and post-swallow vallecular residue with thin liquids, regardless of treatment condition. Stage transition duration (a measure of the duration of the bolus presence in the pharynx prior to swallow initiation, which had been chosen to capture impairments in oral bolus control) showed no significant differences. Similarly, significant improvements were not seen in median scores on the penetration-aspiration scale. This trial suggests that tongue strength can be improved with resistance training for individuals with tongue weakness following stroke. We conclude that improved penetration-aspiration does not necessarily accompany improvements in tongue strength; however, tongue-pressure resistance training does appear to be effective for reducing thin liquid vallecular residue.

  17. Paracervical compared with intracervical lidocaine for suction curettage: a randomized controlled trial.

    Science.gov (United States)

    Mankowski, Jennifer L; Kingston, Jessica; Moran, Thomas; Nager, Charles W; Lukacz, Emily S

    2009-05-01

    To estimate the efficacy of paracervical compared with intracervical administration of local anesthesia during first-trimester suction curettage. A double-blind, randomized controlled trial comparing paracervical with intracervical lidocaine was performed in women undergoing elective first-trimester suction curettage with conscious sedation. Pain was assessed at baseline, with dilation, and with curettage using a 10-cm visual analog scale (VAS). Assuming a minimal clinically important difference in pain score of 1.6 cm and a mean pain score (+/-standard deviation [SD]) of 4.7 (+/-2.9) cm for paracervical block, 120 patients would provide 80% power with an alpha of .05. For the 132 women randomly assigned, no significant differences in VAS scores (mean+/-SD) were observed between paracervical and intracervical blocks during dilation (2.6+/-2.3 compared with 2.8+/-2.2, P=.72) or curettage (3.9+/-2.9 compared with 3.3+/-2.5, P=.16). For women undergoing first-trimester suction curettage with conscious sedation, there was no clinically meaningful difference in pain relief between paracervical and intracervical lidocaine. Providers should feel confident that both techniques provide equally effective and acceptable analgesia.

  18. COMPARATIVE EFFICACY OF MISOPROSTOL AND OXYTOCIN AS LABOR PREINDUCTION AGENTS: A PROSPECTIVE RANDOMIZED TRIAL

    Directory of Open Access Journals (Sweden)

    Zh. Abedi Asl

    2007-09-01

    Full Text Available The purpose of this study was to compare the efficacy and safety of misoprostol and oxytocin for induction of labor. In this prospective and randomized controlled trial one hundred twenty women with an unfavorable cervix who underwent labor induction were assigned to receive either intravenous high dose oxytocin(6mIu/min or intravaginal misoprostol 50µg every 6 hours for two doses. Twelve hours later if labor was not stablished oxytocin induction was initiated per standardized protocol (3mIu/min. Mean Bishop Score change (± SD over the initial 12 hours interval was significantly greater in the misoprostol group (11.98± 1.55 compared with the oxytocin group (8.83 ± 2.61. There were no statistically significant differences in the median duration of labor ( 449±261.1 min, 514.5±288.5 min, respectively;p=0.22 , the mode of delivery or the adverse maternal /neonatal out come among the two groups.Use of misoprostol as a labor preinduction / labor induction agent results in greater Bishop score changes compared with high dose oxytocin and both of them are comparable.

  19. A Randomized Controlled Trial Comparing Telemedical and Standard Outpatient Monitoring of Diabetic Foot Ulcers

    DEFF Research Database (Denmark)

    Rasmussen, Benjamin S B; Froekjaer, Johnny; Bjerregaard, Mads R

    2015-01-01

    OBJECTIVE: The role of telemedical monitoring in diabetic foot ulcer care is still uncertain. Our aim was to compare telemedical and standard outpatient monitoring in the care of patients with diabetic foot ulcers in a randomized controlled trial. RESEARCH DESIGN AND METHODS: Of the 736 screened...... individuals with diabetic foot ulcers, 401 met the eligibility criteria and were randomized between October 2010 and November 2014. The per-protocol telemedical monitoring consisted of two consultations in the patient's own home and one consultation at the outpatient clinic. Standard practice consisted...... monitoring, a higher mortality throws into question the role of telemedicine in monitoring diabetic foot ulcers. Further studies are needed to investigate effects of telemedicine on mortality and other clinical outcomes and to identify patient subgroups that may have a poorer outcome through telemedical...

  20. Tension free vaginal tape (TVT) vs Transobturator tape (TOT) complications and outcomes.

    Science.gov (United States)

    Potić, Milan; Ignjatović, Ivan; Bašić, Dragoslav

    2014-01-01

    Stress urinary incontinence (SUI) is managed with both TVT and TOT. The TVT route of placement could result in a higher com-plication rate. The aim of this study is to analyze and compare outcomes and complications of TVT and TOT in SUI treatment. Prospective study in 64 women with isolated SUI was validated through Urogenital Distress Inventory (UDI-6), Incontinence Impact questionnaire (IIQ-7) and International Continence Impact Questionnaire (ICIQ5-SF). Intraoperative and postoperative complications were noted. Patients were considered cured when negative on stress test and with no need for additional surgery during follow up, after one and three months. The cure rates for both TVT 26/30 (86,6%) and TOT 30/34 (88,2) were comparable. Higher rates of bleeding, bladder perforations, pain and dyspareunia are recorded in TVT group. Quality of life graded on the questionnaire basis proved significant improvement in both procedures. Both TVT and TOT have comparable cure results in the treatment of SUI. The TOT is equally effective in the SUI treatment with significantly lower complication incidence.

  1. Comparability of patients with ANCA-associated vasculitis enrolled in clinical trials or in observational cohorts

    Science.gov (United States)

    Pagnoux, Christian; Carette, Simon; Khalidi, Nader A.; Walsh, Michael; Hiemstra, Thomas F.; Cuthbertson, David; Langford, Carol; Hoffman, Gary S.; Koening, Curry L.; Monach, Paul A.; Moreland, Larry; Mouthon, Luc; Seo, Phil; Specks, Ulrich; Ytterberg, Steven; Westman, Kerstin; Hoglund, Peter; Harper, Lorraine; Flossmann, Oliver; Luqmani, Raashid; Savage, Caroline; Rasmussen, Niels; de Groot, Kirstin; Tesar, Vladimir; Jayne, David; Merkel, Pater A.; Guillevin, Loic

    2015-01-01

    Objective To analyse the differences between patients with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) entered into randomised clinical trials (RCTs) and those followed in large observational cohorts. Methods The main characteristics and outcomes of patients with generalised and/or severe GPA or MPA with a five-factor score ≥1 enrolled in the French Vasculitis Study Group (FVSG) or the US-Canadian-based Vasculitis Clinical Research Consortium cohorts were compared to those enrolled in one of 2 FVSG clinical RCTs (WEG91, WEGENT) or 3 European Vasculitis Society clinical trials (CYCLOPS, CYCAZAREM, IMPROVE). Results 657 patients (65.3% with GPA) in RCTs were compared to 437 in cohorts (90.6% with GPA). RCT patients were older at diagnosis than the cohort patients (56.6±13.9 vs. 46.8±17.3 years), had higher Birmingham vasculitis activity score (19.5±9.1 vs. 16.9±7.4), and more frequent kidney disease (84.0% vs. 54.9%) but fewer ear, nose, and throat symptoms (56.8% vs. 72.2%). At 56 months post-diagnosis, mortality and relapse rates, adjusted for age and renal function, were higher for patients with GPA in RCTs vs. cohorts (10.7% vs. 2.5% [p=0.001] and 22.5% vs. 15.6% [p=0.03], respectively) but similar for patients with MPA (6.2% vs. 6.6% [p=0.92] and 16.6% vs. 10.1% [p=0.39], respectively). Conclusion Patients with GPA or MPA in RCTs and those in observational cohorts show important differences that should be remembered when interpreting results based on these study populations. PMID:26016754

  2. Misoprostol With Foley Bulb Compared With Misoprostol Alone for Cervical Ripening: A Randomized Controlled Trial.

    Science.gov (United States)

    Al-Ibraheemi, Zainab; Brustman, Lois; Bimson, Brianne E; Porat, Natalie; Rosenn, Barak

    2018-01-01

    To test the hypothesis that cervical ripening using a combination of misoprostol and a transcervical Foley bulb leads to delivery within a shorter time compared with misoprostol alone. This randomized controlled trial was offered to women admitted for cervical ripening. Inclusion criteria were gestational age 37 weeks or greater with intact membranes, singleton fetus, cephalic presentation, and Bishop score 6 or less. Exclusion criteria included, among others, prior uterine surgery, ruptured membranes, and any contraindication to vaginal delivery. Patients were randomized to cervical ripening using misoprostol and a transcervical Foley bulb simultaneously or misoprostol alone. Primary outcome was time from placement of the misoprostol to delivery. Secondary outcomes included time to active phase, time from active phase to delivery, cesarean delivery rate, uterine tachysystole, estimated blood loss, chorioamnionitis, cord pH, 5-minute Apgar score, and neonatal intensive care unit admission. Sample size calculation revealed that 94 participants were required in each group to detect a 3-hour difference with 80% power and α error of 0.05. Intention-to-treat analysis was performed. From September 2015 to July 2016, a total of 200 patients were randomized, 100 to each group. There were no differences between groups with respect to parity, body mass index, gestational age, Bishop score, birth weight, or indication for induction. Time to delivery was significantly shorter in the combined misoprostol-transcervical Foley group: 15.0 (11.0-21.8) hours (median [interquartile range]) vs 19.0 (14.0-27.3) hours in the misoprostol-only group (P=.001). This time difference remained significant after subanalysis by parity or after excluding cesarean deliveries. There was no difference between groups with respect to the rate or indication for cesarean delivery, estimated blood loss, rate of tachysystole, chorioamnionitis, or neonatal outcomes. Cervical ripening using misoprostol in

  3. Human Papillomavirus Vaccination in Tanzanian Schoolgirls: Cluster-Randomized Trial Comparing 2 Vaccine-Delivery Strategies

    Science.gov (United States)

    Watson-Jones, Deborah; Baisley, Kathy; Ponsiano, Riziki; Lemme, Francesca; Remes, Pieter; Ross, David; Kapiga, Saidi; Mayaud, Philippe; de Sanjosé, Silvia; Wight, Daniel; Changalucha, John; Hayes, Richard

    2012-01-01

    Background.We compared vaccine coverage achieved by 2 different delivery strategies for the quadrivalent human papillomavirus (HPV) vaccine in Tanzanian schoolgirls. Methods.In a cluster-randomized trial of HPV vaccination conducted in Tanzania, 134 primary schools were randomly assigned to class-based (girls enrolled in primary school grade [class] 6) or age-based (girls born in 1998; 67 schools per arm) vaccine delivery. The primary outcome was coverage by dose. Results.There were 3352 and 2180 eligible girls in schools randomized to class-based and age-based delivery, respectively. HPV vaccine coverage was 84.7% for dose 1, 81.4% for dose 2, and 76.1% for dose 3. For each dose, coverage was higher in class-based schools than in age-based schools (dose 1: 86.4% vs 82.0% [P = .30]; dose 2: 83.8% vs 77.8% [P = .05]; and dose 3: 78.7% vs 72.1% [P = .04]). Vaccine-related adverse events were rare. Reasons for not vaccinating included absenteeism (6.3%) and parent refusal (6.7%). School absenteeism rates prior to vaccination ranged from 8.1% to 23.5%. Conclusions.HPV vaccine can be delivered with high coverage in schools in sub-Saharan Africa. Compared with age-based vaccination, class-based vaccination located more eligible pupils and achieved higher coverage. HPV vaccination did not increase absenteeism rates in selected schools. Innovative strategies will be needed to reach out-of-school girls. Clinical Trials Registration. NCT01173900. PMID:22711908

  4. Prevention of epidural scarring after microdiscectomy: a randomized clinical trial comparing gel and expanded polytetrafluoroethylene membrane.

    Science.gov (United States)

    Ivanic, Gerd M; Pink, Peter T; Schneider, Frank; Stuecker, Markus; Homann, Nicolaus C; Preidler, Klaus W

    2006-09-01

    A randomized clinical trial compared two materials used to prevent epidural scarring after microdiscectomy. To determine whether ADCON-L Gel (ALG) or Preclude Spinal Membrane (PSM) was more effective in preventing scarring, reducing pain, and improving quality of life postoperatively. Postdiscectomy syndrome may result from epidural scarring. Various materials have been used in attempts to prevent this problem, but none have provided optimal results. Previous laboratory and clinical studies have found ALG and PSM to be effective, but none compared the two materials. Thirty-one patients undergoing primary microdiscectomy were randomly assigned to receive either ALG or PSM. Postoperatively, patients were evaluated by magnetic resonance imaging (MRI), with contrast, for volume and rostral-caudal extent of scar tissue and nerve root involvement. Back and leg pain and quality of life were assessed by neurologic examinations and standardized patient surveys. Findings at any reoperations were recorded. Results in the PSM (n = 18) and ALG (n = 13) groups were compared statistically. No operative or postoperative complications occurred. Two patients in each group required reoperation. MRI at 6 months showed no, mild or mild-moderate scarring in most patients, with no significant differences between the ALG and PSM groups in scar volume and extent or nerve root involvement. Neurologic examinations and patient surveys showed substantial reductions in pain over time in both groups but no significant differences between groups. PSM was easy to see and remove at reoperation. PSM and ALG are equally effective in preventing epidural scarring associated with postdiscectomy syndrome.

  5. Continuous Compared With Cyclic Oral Contraceptives for the Treatment of Primary Dysmenorrhea: A Randomized Controlled Trial

    Science.gov (United States)

    Dmitrovic, Romana; Kunselman, Allen R.; Legro, Richard S.

    2013-01-01

    Objective To estimate whether continuous OCP (oral contraceptive pills) will result in more pain relief in primary dysmenorrhea patients than cyclic OCP, which induces withdrawal bleeding with associated pain and symptoms. Material and Methods We conducted a double-blind, randomized controlled trial comparing continuous to a cyclic 21/7 OCP regimen (gestodene 0.075 mg and ethinyl estradiol 20 mcg) for 6 months in 38 primary dysmenorrhea patients. The primary outcome was the difference in subjective perception of pain as measured by the Visual Analog Scale (VAS) over the period of 6 months. Results Twenty-nine patients completed the study. In both groups, pain reduction measured by VAS declined over time and was significant at 6 months compared to baseline with no difference between groups. Continuous regimen was superior to cyclic regimen after one month (mean difference: -27.3; 95% CI: (-40.5,-14.2); p<0.001) and 3 months (mean difference: -17.8; 95% CI: (-33.4,-2.1); p=0.03) of treatment. Secondary outcomes noted no difference between groups in terms of menstrual distress as measured by the Moos Menstrual Distress Questionnaire. After 6 months, there was an increase in weight and decrease in systolic blood pressure in continuous compared with the cyclic group. Conclusions Both regimens of OCP are effective in the treatment of primary dysmenorrhea. Continuous OCP outperforms cyclic OCP in the short term, but this difference is lost after 6 months. PMID:22617578

  6. Effect of progestin compared with combined oral contraceptive pills on lactation: a randomized controlled trial.

    Science.gov (United States)

    Espey, Eve; Ogburn, Tony; Leeman, Lawrence; Singh, Rameet; Ostrom, Katie; Schrader, Ronald

    2012-01-01

    To estimate the effect of progestin-only compared with combined hormonal contraceptive pills on rates of breastfeeding continuation in postpartum women. Secondary outcomes include infant growth parameters, contraceptive method continuation, and patient satisfaction with breastfeeding and contraceptive method. Postpartum breastfeeding women who desired oral contraceptives were randomly assigned to progestin-only and combined hormonal contraceptive pills. At 2 and 8 weeks postpartum, participants completed in-person questionnaires that assessed breastfeeding continuation and contraceptive use. Infant growth parameters including weight, length, and head circumference were assessed at 8 weeks postpartum. Telephone questionnaires assessing breastfeeding, contraceptive continuation, and satisfaction were completed at 3-7 weeks and 4 and 6 months. Breastfeeding continuation was compared between groups using Cox proportional hazards regression. Differences in baseline demographic characteristics and in variables between the two intervention groups were compared using χ tests, Fisher exact test, or two-sample t tests as appropriate. Breastfeeding continuation rates at 8 weeks (progestin-only 63.5%; combined hormonal 64.1%), contraceptive continuation, and infant growth parameters did not differ between users of progestin-only and combined hormonal contraceptive pills. Infant formula supplementation and maternal perception of inadequate milk supply were associated with decreased rates of breastfeeding in both groups. Choice of combined hormonal or progestin-only contraceptive pills administered 2 weeks postpartum did not adversely affect breastfeeding continuation. ClinicalTrials.gov, www.clinicaltrials.gov, NCT01465022.

  7. Protocol for the saMS trial (supportive adjustment for multiple sclerosis: a randomized controlled trial comparing cognitive behavioral therapy to supportive listening for adjustment to multiple sclerosis

    Directory of Open Access Journals (Sweden)

    McCrone Paul

    2009-08-01

    Full Text Available Abstract Background Multiple Sclerosis (MS is an incurable, chronic, potentially progressive and unpredictable disease of the central nervous system. The disease produces a range of unpleasant and debilitating symptoms, which can have a profound impact including disrupting activities of daily living, employment, income, relationships, social and leisure activities, and life goals. Adjusting to the illness is therefore particularly challenging. This trial tests the effectiveness of a Cognitive Behavioural intervention compared to Supportive Listening to assist adjustment in the early stages of MS. Methods/Design This is a two arm randomized multi-centre parallel group controlled trial. 122 consenting participants who meet eligibility criteria will be randomly allocated to receive either Cognitive Behavioral Therapy or Supportive Listening. Eight one hour sessions of therapy (delivered over a period of 10 weeks will be delivered by general nurses trained in both treatments. Self-report questionnaire data will be collected at baseline (0 weeks, mid-therapy (week 5 of therapy, post-therapy (15 weeks and at six months (26 weeks and twelve months (52 weeks follow-up. Primary outcomes are distress and MS-related social and role impairment at twelve month follow-up. Analysis will also consider predictors and mechanisms of change during therapy. In-depth interviews to examine participants' experiences of the interventions will be conducted with a purposively sampled sub-set of the trial participants. An economic analysis will also take place. Discussion This trial is distinctive in its aims in that it aids adjustment to MS in a broad sense. It is not a treatment specifically for depression. Use of nurses as therapists makes the interventions potentially viable in terms of being rolled out in the NHS. The trial benefits from incorporating patient input in the development and evaluation stages. The trial will provide important information about the

  8. Comparing the Effectiveness of a Clinical Registry and a Clinical Data Warehouse for Supporting Clinical Trial Recruitment: A Case Study

    Science.gov (United States)

    Weng, Chunhua; Bigger, J Thomas; Busacca, Linda; Wilcox, Adam; Getaneh, Asqual

    2010-01-01

    This paper reports a case study comparing the relative efficiency of using a Diabetes Registry or a Clinical Data Warehouse to recruit participants for a diabetes clinical trial, TECOS. The Clinical Data Warehouse generated higher positive predictive accuracy (31% vs. 6.6%) and higher participant recruitment than the Registry (30 vs. 14 participants) in a shorter time period (59 vs. 74 working days). We identify important factors that increase clinical trial recruitment efficiency and lower cost. PMID:21347102

  9. Apnea after Awake Regional and General Anesthesia in Infants : The General Anesthesia Compared to Spinal Anesthesia Study-Comparing Apnea and Neurodevelopmental Outcomes, a Randomized Controlled Trial

    NARCIS (Netherlands)

    Davidson, Andrew J.; Morton, Neil S.; Arnup, Sarah J.; De Graaff, Jurgen C.; Disma, Nicola; Withington, Davinia E.; Frawley, Geoff; Hunt, Rodney W.; Hardy, Pollyanna; Khotcholava, Magda; Von Ungern Sternberg, Britta S.; Wilton, Niall; Tuo, Pietro; Salvo, Ida; Ormond, Gillian; Stargatt, Robyn; Locatelli, Bruno Guido; McCann, Mary Ellen; Lee, Katherine; Sheppard, Suzette; Hartmann, Penelope; Ragg, Philip; Backstrom, Marie; Costi, David; Von Ungern-Sternberg, Britta S.; Knottenbelt, Graham; Montobbio, Giovanni; Mameli, Leila; Giribaldi, Gaia; Prato, Alessio Pini; Mattioli, Girolamo; Wolfler, Andrea; Izzo, Francesca; Sonzogni, Valter; Van Gool, Jose T D G; Numan, Sandra C.; Kalkman, Cor J.; Hagenaars, J. H M; Absalom, Anthony R.; Hoekstra, Frouckje M.; Volkers, Martin J.; Furue, Koto; Gaudreault, Josee; Berde, Charles; Soriano, Sulpicio; Young, Vanessa; Sethna, Navil; Kovatsis, Pete; Cravero, Joseph P.; Bellinger, David; Marmor, Jacki; Lynn, Anne; Ivanova, Iskra; Hunyady, Agnes; Verma, Shilpa; Polaner, David; Thomas, Joss; Meuller, Martin; Haret, Denisa; Szmuk, Peter; Steiner, Jeffery; Kravitz, Brian; Suresh, Santhanam; Hays, Stephen R.; Taenzer, Andreas H.; Maxwell, Lynne G.; Williams, Robert K.; Bell, Graham T.; Dorris, Liam; Adey, Claire; Bagshaw, Oliver; Chisakuta, Anthony; Eissa, Ayman; Stoddart, Peter; Davis, Annette; Myles, Paul; Wolf, Andy; McIntosh, Neil; Carlin, John; Leslie, Kate; De Lima, Jonathan; Hammer, Greg; Field, David; Gebski, Val; Tibboel, Dick

    2015-01-01

    Background: Postoperative apnea is a complication in young infants. Awake regional anesthesia (RA) may reduce the risk; however, the evidence is weak. The General Anesthesia compared to Spinal anesthesia study is a randomized, controlled trial designed to assess the influence of general anesthesia

  10. Apnea after Awake Regional and General Anesthesia in Infants : The General Anesthesia Compared to Spinal Anesthesia Study-Comparing Apnea and Neurodevelopmental Outcomes, a Randomized Controlled Trial

    NARCIS (Netherlands)

    Davidson, Andrew J; Morton, Neil S; Arnup, Sarah J; de Graaff, Jurgen C; Disma, Nicola; Withington, Davinia E; Frawley, Geoff; Hunt, Rodney W; Hardy, Pollyanna; Khotcholava, Magda; von Ungern Sternberg, Britta S; Wilton, Niall; Tuo, Pietro; Salvo, Ida; Ormond, Gillian; Stargatt, Robyn; Locatelli, Bruno Guido; McCann, Mary Ellen; Absalom, Anthony

    BACKGROUND: Postoperative apnea is a complication in young infants. Awake regional anesthesia (RA) may reduce the risk; however, the evidence is weak. The General Anesthesia compared to Spinal anesthesia study is a randomized, controlled trial designed to assess the influence of general anesthesia

  11. Comparative costs and activity from a sample of UK clinical trials units.

    Science.gov (United States)

    Hind, Daniel; Reeves, Barnaby C; Bathers, Sarah; Bray, Christopher; Corkhill, Andrea; Hayward, Christopher; Harper, Lynda; Napp, Vicky; Norrie, John; Speed, Chris; Tremain, Liz; Keat, Nicola; Bradburn, Mike

    2017-05-02

    The costs of medical research are a concern. Clinical Trials Units (CTUs) need to better understand variations in the costs of their activities. Representatives of ten CTUs and two grant-awarding bodies pooled their experiences in discussions over 1.5 years. Five of the CTUs provided estimates of, and written justification for, costs associated with CTU activities required to implement an identical protocol. The protocol described a 5.5-year, nonpharmacological randomized controlled trial (RCT) conducted at 20 centres. Direct and indirect costs, the number of full time equivalents (FTEs) and the FTEs attracting overheads were compared and qualitative methods (unstructured interviews and thematic analysis) were used to interpret the results. Four members of the group (funding-body representatives or award panel members) reviewed the justification statements for transparency and information content. Separately, 163 activities common to trials were assigned to roles used by nine CTUs; the consistency of role delineation was assessed by Cohen's κ. Median full economic cost of CTU activities was £769,637 (range: £661,112 to £1,383,323). Indirect costs varied considerably, accounting for between 15% and 59% (median 35%) of the full economic cost of the grant. Excluding one CTU, which used external statisticians, the total number of FTEs ranged from 2.0 to 3.0; total FTEs attracting overheads ranged from 0.3 to 2.0. Variation in directly incurred staff costs depended on whether CTUs: supported particular roles from core funding rather than grants; opted not to cost certain activities into the grant; assigned clerical or data management tasks to research or administrative staff; employed extensive on-site monitoring strategies (also the main source of variation in non-staff costs). Funders preferred written justifications of costs that described both FTEs and indicative tasks for funded roles, with itemised non-staff costs. Consistency in role delineation was fair (κ

  12. Randomized comparative trial of a social cognitive skills group for children with autism spectrum disorder.

    Science.gov (United States)

    Soorya, Latha V; Siper, Paige M; Beck, Todd; Soffes, Sarah; Halpern, Danielle; Gorenstein, Michelle; Kolevzon, Alexander; Buxbaum, Joseph; Wang, A Ting

    2015-03-01

    This study evaluated the efficacy of a targeted social skills training group in school-aged children with autism spectrum disorder (ASD). The intervention, Seaver-NETT (Nonverbal communication, Emotion recognition, and Theory of mind Training), is a 12-session cognitive-behavioral intervention (CBI) for verbal, school-aged children targeting ASD-specific social behavioral impairments. Sixty-nine children with ASD, 8 to 11 years of age, with verbal IQs greater than 70, participated in a randomized comparative trial to examine the efficacy of NETT relative to a facilitated play group. Treatment outcomes included caregiver reports of social behavior and neuropsychological assessments of social cognition conducted by blinded raters. Outcomes were collected at baseline, endpoint, and 3 months posttreatment. Significant improvements were found on social behavior outcomes such as nonverbal communication, empathic responding, and social relations in the NETT condition relative to the active control at endpoint. Verbal IQ moderated the interaction effect on social behavior, with higher verbal IQ associated with improvements in the CBI condition. No significant improvements were found on social cognitive outcomes. No significant group differences were found at 3-month follow-up conducted with approximately half the sample (n = 34). These data indicate that targeted CBI social skills groups such as NETT improve social communication deficits in verbal, school-aged children with ASD. The moderating effects of high verbal IQ suggest a need to consider participant and treatment characteristics associated with outcomes in future studies. Clinical trial registration information-Neural and Behavioral Outcomes of Social Skills Groups in Children With Autism Spectrum Disorder; https://clinicaltrials.gov; NCT01190917. Copyright © 2015 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

  13. Randomized clinical trial comparing cold knife conization of the cervix with and without lateral hemostatic sutures.

    Science.gov (United States)

    Bueno, Letícia Rossi; Binda, Marcia; Monego, Heleusa; Scherer, Roberta Luísa; Rolim, Karen Machado; Bottini, Alessandra Leal; Fregnani, José H T G; dos Reis, Ricardo

    2015-06-01

    Compare blood loss during cold knife conization of the cervix with and without lateral hemostatic sutures in the cervical branches of the uterine arteries. Randomized clinical trial. Hospital de Clínicas de Porto Alegre (HCPA). 102 patients that underwent cold knife conization. Women that underwent cold knife conization of the cervix were randomized to undergo the procedure with or without lateral hemostatic sutures. blood loss measured in grams. operative time and postoperative intervention. Only the participants were blinded to group assignment. From March 2009 to August 2012, patients were randomly assigned to one of the study groups. There were no differences in amount of blood loss between patients that underwent the procedure with and without sutures (p = 0.39). Operative time was shorter in the group without suture (p = 0.020). There were no differences in intervention due to bleeding (p = 0.20). Blood loss was greater among menstruating women than for menopausal women (p = 0.011). There were no differences in amount of blood lost between smoking and nonsmoking patients (p = 0.082). Lateral hemostatic sutures do not affect the amount of intraoperative bleeding or the number of postoperative interventions. Their use is not necessary because they result in longer operative time, have a higher cost due to the use of suture material and pose the risk of ureter lesion in case the sutures are not placed at a lower position in the cervix. ClinicalTrials. gov identifier: NCT02184975. Copyright © 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.

  14. A randomized, comparative trial: does pillow type alter cervico-thoracic spinal posture when side lying?

    Directory of Open Access Journals (Sweden)

    Gordon SJ

    2011-08-01

    Full Text Available Susan J Gordon1, Karen A Grimmer-Somers2, Patricia H Trott31School of Public Health, Tropical Medicine and Rehabilitation Science, James Cook University, Townsville, QLD; 2Centre for Allied Health Sciences, 3School of Health Sciences, University of South Australia, Adelaide, SA, AustraliaBackground: Many patients ask for advice about choosing a pillow. This research was undertaken to determine if pillow type alters cervico-thoracic spine position when resting in the side-lying position.Aim: To investigate the effect of different pillow shape and content on the slope of cervico-thoracic spine segments when side lying.Materials and methods: The study was a randomized blinded comparative trial set in a laboratory that replicated a bedroom. The subjects were side sleepers aged over 18 years. Exclusion criteria were history of surgery to the cervico-thoracic spine, an injury or accident to the cervico-thoracic spine in the preceding year, or currently receiving treatment for neck symptoms. Each participant rested in a standardized side-lying position for 10 minutes on each of the trial pillows: regular shaped polyester, foam, feather, and latex pillows, and a contour shaped foam pillow. Reflective markers were placed on external occipital protuberance (EOP, C2, C4, C7, and T3, and digital images were recorded of subjects at 0 and 10 minutes on each pillow. Images were digitized using each reflective marker and the slope of each spinal segment calculated. Univariate analysis of variance models were used to investigate slope differences between pillows at 0 and 10 minutes. Significance was established at P < 0.01 to take account of chance effects from repeated measures and multiple comparisons.Results: At 0 and 10 minutes, the EOP-C2, C2-C4, and C4-C7 segmental slopes were significantly different across all pillows. Significant differences were identified when comparing the feather pillow with the latex, regular and contour foam pillows, and when

  15. Pelvic floor muscle functions are improved after successful transobturator vaginal mesh procedures.

    Science.gov (United States)

    Huang, Wen-Chen; Yang, Shwu-Huey; Yang, Jenn-Ming

    2017-02-01

    To explore functional changes of pelvic floor muscle (PFM) after successful Perigee procedures. We retrospectively analyzed information from 145 women having achieved anatomic success, defined as pelvic organ prolapse quantification (POP-Q) system. The investigated data included results from the POP-Q system and four-dimensional ultrasound at the preoperative and 12-month postoperative evaluations. The involuntary and voluntary PFM functions were, respectively, investigated during coughing and squeezing using the ultrasound parameters of the bladder neck distance (BND), bladder neck angle (BNA), genitohiatal distance (GHD), and genitohiatal angle. Postoperatively more women displayed normal involuntary PFM function in maintaining a stable bladder neck (preoperative vs. postoperative: 4.8% vs. 22.8%, P < 0.001) and genitohiatal (preoperative vs. postoperative: 16.6% vs. 30.3%, P = 0.008) locations upon coughing and could perform voluntary PFM contractions (preoperative vs. postoperative: 49.7% vs. 64.1%, P = 0.018). Compared with preoperative manifestations, less caudal displacement of the bladder neck indicated by smaller ranges of dynamic changes in BNA following coughing (preoperative vs. postoperative: 28° vs. 12°, P < 0.001), more cranial movement of the bladder neck indicated by larger values of changes in BND following squeezing (-0.26 vs. 0.06 cm, P < 0.001), and less reduction of genitohiatal size indicated by larger values of changes in GHD following squeezing (preoperative vs. postoperative: -0.95 vs. -0.63 cm, P = 0.027) were demonstrated postoperatively. Involuntary and voluntary PFM functions are improved after successful Perigee procedures. Neurourol. Urodynam. 36:380-384, 2017. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

  16. A clinical trial comparing Lanconone® with ibuprofen for rapid relief in acute joint pain.

    Science.gov (United States)

    Girandola, Robert N; Srivastava, Shalini; Loullis, Costas C

    2016-04-06

    To study the effect of Lanconone® (1000 mg) on acute pain on exertion as compared to the standard of care, Ibuprofen (400 mg). The study recruited 72 subjects diagnosed with mild to moderate knee joint pain on exertion. Subjects with Pain Visual Analogue Scale of more than 40 mm were included. Uphill walking was provided as the stressor using Naughton's protocol on a treadmill. The subjects walked for 10 minutes continuously followed by a rest period and baseline pain score for index knee joint was recorded. Subjects were administered a single dose of Lanconone® (1000 mg)/Ibuprofen (400 mg). Thereafter the same stressor was provided at 0.5, 1, 2, 3, 4, and 6 hours, subsequently, pain scores were recorded on a visual analogue scale. Double stopwatch method was used to evaluate the onset of pain relief and time taken to meaningful pain relief. Both Lanconone® and Ibuprofen showed the first perceived pain relief at 65.31 ± 35.57 mins as compared to 60.82 ± 32.56 mins respectively. The mean time taken to experience meaningful pain relief in Lanconone® group was 196.59 ± 70.85 mins compared to 167.13 ± 71.41 mins amongst Ibuprofen group. The meaningful pain relief continued for 6 hours. The current study successfully demonstrated rapid pain-relieving potential of Lanconone® which was comparable to Ibuprofen. No adverse event related to the interventions was reported in the study. Clinical trials.gov NCT02417506 . 21 January 2015.

  17. Comparing the effects of Calendula officinalis and clotrimazole on vaginal Candidiasis: A randomized controlled trial.

    Science.gov (United States)

    Saffari, Elnaz; Mohammad-Alizadeh-Charandabi, Sakineh; Adibpour, Mohammad; Mirghafourvand, Mojgan; Javadzadeh, Yousef

    2017-01-01

    This triple-blind trial examined the effects of Calendula officinalis vaginal cream on the treatment of vaginal Candidiasis (primary outcome) and sexual function (secondary outcome). Married women aged 18-45 years with vaginal Candidiasis (n = 150) were recruited from April to October 2014 and randomized into Calendula and clotrimazole groups, using 5-g vaginal cream every night for seven nights. Clinical and laboratory assessments were conducted at 10-15 and 30-35 days after intervention and the female sexual function index was assessed at 30-35 days. Six women were lost to follow-up. The frequency of testing negative for Candidiasis in the Calendula group was significantly lower at the first (49% vs. 74%; odds ratio (OR) 0.32; 95% confidence interval (CI) 0.16-0.67) but higher at the second (77% vs. 34%; OR 3.1; 95% CI 1.5-6.2) follow-up compared to the clotrimazole group. The frequency of most signs and symptoms were almost equal in the two groups at the first follow-up, but were significantly lower in the Calendula group at the second follow-up. Sexual function had almost equal significant improvement in both groups. Calendula vaginal cream appears to have been effective in the treatment of vaginal Candidiasis and to have a delayed but greater long-term effect compared to clotrimazole.

  18. Raisins compared with other snack effects on glycemia and blood pressure: a randomized, controlled trial.

    Science.gov (United States)

    Anderson, James W; Weiter, Kathy M; Christian, Amber L; Ritchey, Michelle B; Bays, Harold E

    2014-01-01

    To compare effects of raisin snacks with conventional snacks on glycemia and cardiovascular risk factors. A 12-week, randomized, controlled trial compared 3-times-a-day consumption of raisins with intake of processed snacks on glycemia and cardiovascular risk factors. Men and women were randomized to snacks (n = 15) or raisins (n = 31). Outcome measures were performed at baseline, 4, 8, and 12 weeks. Fasting plasma glucose levels were not significantly affected by intake of raisins or snacks. Mean subject post prandial glucose levels were significantly reduced by raisin intake at 12 weeks; changes with raisin intake were -13.1 mg/dL (P = 0.003 vs baseline; P = 0.03 vs snacks). Eating raisins significantly decreased glycated hemoglobin (HbA1c) level (-0.12%; P = 0.004), a significantly greater level decrease than seen with snack intake (P = 0.036). Snack intake did not significantly affect subject systolic or diastolic blood pressure (BP). Raisin intake was associated with reductions in systolic blood pressure (SBP) at 4, 8, and 12 weeks with mean changes of -6.0 to 10.2 mmHg; all these changes were statistically significant (P = 0.015 to 0.001). Raisins were associated with significantly greater changes in diastolic blood pressure (DBP) at 4, 8, and 12 weeks than snacks (P consumption of raisins may reduce glycemia and cardiovascular risk factors, including BP rate.

  19. A randomized controlled trial comparing EMDR and CBT for obsessive-compulsive disorder.

    Science.gov (United States)

    Marsden, Zoe; Lovell, Karina; Blore, David; Ali, Shehzad; Delgadillo, Jaime

    2018-01-01

    This study aimed to evaluate eye movement desensitization and reprocessing (EMDR) as a treatment for obsessive-compulsive disorder (OCD), by comparison to cognitive behavioural therapy (CBT) based on exposure and response prevention. This was a pragmatic, feasibility randomized controlled trial in which 55 participants with OCD were randomized to EMDR (n = 29) or CBT (n = 26). The Yale-Brown obsessive-compulsive scale was completed at baseline, after treatment and at 6 months follow-up. Treatment completion and response rates were compared using chi-square tests. Effect size was examined using Cohen's d and multilevel modelling. Overall, 61.8% completed treatment and 30.2% attained reliable and clinically significant improvement in OCD symptoms, with no significant differences between groups (p > .05). There were no significant differences between groups in Yale-Brown obsessive-compulsive scale severity post-treatment (d = -0.24, p = .38) or at 6 months follow-up (d = -0.03, p = .90). EMDR and CBT had comparable completion rates and clinical outcomes. Copyright © 2017 John Wiley & Sons, Ltd.

  20. Metformin compared with insulin in the management of gestational diabetes mellitus: a randomized clinical trial.

    Science.gov (United States)

    Niromanesh, Shirin; Alavi, Azin; Sharbaf, Fatemeh Rahimi; Amjadi, Nooshin; Moosavi, Sanaz; Akbari, Soheila

    2012-12-01

    To evaluate the effect of metformin and insulin in glycemic control and compare pregnancy outcome in women with gestational diabetes mellitus (GDM). This randomized controlled trial was conducted in GDM women with singleton pregnancy and gestational age between 20 and 34 weeks who did not achieve glycemic control on diet were assigned randomly to receive either metformin (n=80) or insulin (n=80). The primary outcomes were maternal glycemic control and birth weight. The secondary outcomes were neonatal and obstetric complications. Two groups were comparable regarding the maternal characteristics. Two groups were similar in mean FBS (P=0.68) and postprandial measurements (P=0.87) throughout GDM treatment. The neonates of metformin group had less rate of birth weight centile >90 than insulin group (RR: 0.5, 95% CI: 0.3-0.9, P=0.012). Maternal weight gain was reduced in the metformin group (P0.05). In metformin group 14% of women needed to supplemental insulin to achieve euglycemia. Metformin is an effective and safe alternative treatment to insulin for women with GDM. This study does not show significant risk of maternal or neonatal adverse outcome with the use of metformin. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  1. Comparative Effectiveness of Initial Antiretroviral Therapy Regimens: ACTG 5095 and 5142 Clinical Trials Relative to ART-CC Cohort Study

    Science.gov (United States)

    Mugavero, Michael J.; May, Margaret; Ribaudo, Heather J.; Gulick, Roy M.; Riddler, Sharon A.; Haubrich, Richard; Napravnik, Sonia; Abgrall, Sophie; Phillips, Andrew; Harris, Ross; Gill, M. John; de Wolf, Frank; Hogg, Robert; Günthard, Huldrych F.; Chêne, Geneviève; D'Arminio Monforte, Antonella; Guest, Jodie L.; Smith, Colette; Murillas, Javier; Berenguer, Juan; Wyen, Christoph; Domingo, Pere; Kitahata, Mari M.; Sterne, Jonathan A. C.; Saag, Michael S.

    2011-01-01

    Background The generalizability of antiretroviral therapy (ART) clinical trial efficacy findings to routine care settings is not well studied. We compared the relative effectiveness of initial ART regimens estimated in AIDS Clinical Trial Group (ACTG) randomized controlled trials with that among patients receiving ART at Antiretroviral Therapy Cohort Collaboration (ART-CC) study sites. Methods Treatment-naive HIV-infected patients initiating identical ART regimens in ACTG trials (A5095 and A5142) and at 15 ART-CC cohort study sites were included. Virological failure (HIV-1 RNA >200 copies/ml) at 24- and 48-weeks, incident AIDS-defining events and mortality were measured according to study design (ART-CC cohort vs. ACTG trial) and stratified by 3rd drug [Abacavir (ABC), Efavirenz (EFV), and Lopinavir/r (LPV/r)]. We used logistic regression to estimate and compare odds ratios for virological failure between different regimens and study designs, and used Cox models to estimate and compare hazard ratios for AIDS and death. Results Compared with patients receiving ABC, those receiving EFV had roughly half the odds of 24-week virologic failure (>200 copies/mL) in both ACTG 5095 (OR=0.53, 95% CI 0.36–0.79) and ART-CC (0.46, 0.37–0.57). Virologic superiority of EFV (vs. ABC) appeared comparable in ART-CC and ACTG 5095 (ratio of ORs 0.86, 95% CI 0.54–1.35). Odds ratios for 48-week virologic failure, comparing EFV with LPV/r, were also comparable in ACTG 5142 and ART-CC (ratio of ORs 0.87, 0.45–1.69). Conclusions Between ART regimen virologic efficacy of 3rd drugs ABC, EFV, and LPV/r observed in the ACTG 5095 and 5142 trials appear generalizable to the routine care setting of ART-CC clinical cohorts. PMID:21857357

  2. Comparative Study after Hamstring Anterior Cruciate Ligament Reconstruction with Endobutton and Rigidfix: A Clinical Trial Study

    Directory of Open Access Journals (Sweden)

    Hamid Mousavi

    2017-01-01

    Full Text Available Background: One of the most common orthopedic clinic visits involves direct and indirect knee trauma leading to rupture of anterior cruciate ligament (ACL. Endobutton and Rigidfix are most frequent treating methods that used by orthopedic surgeons. Thus the aim of this study was compare the clinical results of reconstructing arthroscopic ACL of the knee through two methods namely Rigidfix and Endobutton. Materials and Methods: In a clinical trial study, a total of 40 patients with rupture of ACL were selected and randomly divided into two groups. The groups were treated through fixation procedures either Endobutton or Rigidfix. Prior to surgery and then at least 2 years after surgery, the patients were under physical examination in terms of knee range of motion, knee stability, knee pain, ability to perform daily activities and exercises and compared between the two groups. Results: The knee range of motion in Endobutton and Rigidfix were 135.73 ± 2.63 and 129.87 ± 7.14° resprectively (P = 0.06. comparing two groups, during last month in Endobutton and Rigidfix the frequency of knee pain were 2.5 ± 1.4 and 3.4 ± 1.4 respectively (P = 0.08. Moreover, the pain intensity score were 2.9 ± 1.5 and 2.6 ± 1.1 (P = 0.49. But there was a significant difference observed in patients' satisfaction and ability to perform sports activities. Conclusions: The two fixation methods namely Endobutton and Rigidfix are not preferred over one another. But patients' satisfaction and ability to perform sports activities in Endobutton was better than the Rigidfix.

  3. A prospective, randomized controlled trial comparing 3 dressing types following sternotomy.

    Science.gov (United States)

    Dickinson Jennings, Cathy; Culver Clark, Rebecca; Baker, Joseph W

    2015-05-01

    Dressings are an important aspect of post-sternotomy care. A prospective, randomized, controlled trial was conducted between July 2010 and August 2012 to compare wound and patient outcomes among 3 marketed postoperative dressings. Using convenience sampling methods, 315 patients requiring a sternotomy incision followed by hospitalization were randomly assigned to postoperative care with a dry sterile (n = 106), metallic silver-containing (n = 105), or ionic silver-containing (n = 104) dressing. Application time and ease of dressing application were assessed. The dry dressings remained in place for 24 to 48 hours. On postoperative day 5 or at time of discharge, the silver dressings were removed and wound outcomes (degree of wound approximation, skin integrity, wound exudate, presence/absence of necrotic tissue), presence/absence of surgical site infection, patient comfort, and dressing factors (ease of removal, dressing integrity) were evaluated. All participants received the same preoperative skin preparation and intravenous antibiotics. Data were analyzed using Fisher's exact chi-squares and 1-way ANOVA. No statistically significant differences were found among the dressings in terms of wound healing or infection rate, but statistically significant differences were noted in patient comfort and certain dressing factors. When comparing all 3 dressings, the dry sterile dressing took less time to apply (P = 0.000) and was easiest to apply (P = 0.000). Use of the metallic silver dressing resulted in the least patient-reported pain upon removal (P = 0.015), and incision assessment was easiest with the ionic silver dressing (P = 0.000). When comparing the 2 silver dressings, the metallic silver dressing was easiest to remove (P = 0.003) but had less integrity at the time of removal (P = 0.007). None of the patients in the ionic silver and 1 patient (1%) in the metallic silver dressing group developed a deep infection. Additional research is warranted to determine best

  4. Oral anticancer drugs: how limited dosing options and dose reductions may affect outcomes in comparative trials and efficacy in patients.

    Science.gov (United States)

    Prasad, Vinay; Massey, Paul R; Fojo, Tito

    2014-05-20

    Historically, cancer medicine has avoided the problem of unequal dosing by comparing maximum-tolerated doses of intravenous regimens with proportionate dose reductions for toxicity. However, in recent years, with the development of numerous oral anticancer agents, dosing options are arbitrarily and increasingly limited by the size of pills. We contend that an underappreciated consequence of pill size is unequal dosing in comparative clinical trials and that this can have an impact on outcomes. We discuss how comparative effectiveness trials can be unbalanced and how the use of doses that are not sustainable might affect outcomes, especially marginal ones. We further argue that because of their poor tolerability and their limited dosing options, which often result in large dose adjustments in response to toxicity, the real-world clinical effectiveness of oral anticancer agents may be diminished and may not emulate results achieved in registration trials. © 2014 by American Society of Clinical Oncology.

  5. Meta-analysis of trials comparing anastrozole and tamoxifen for adjuvant treatment of postmenopausal women with early breast cancer

    Directory of Open Access Journals (Sweden)

    Tas Faruk

    2008-07-01

    Full Text Available Abstract Objective It was aimed to review the literature and make a meta-analysis of the trials on both upfront, switching, and sequencing anastrozole in the adjuvant treatment of early breast cancer. Methods The PubMed, ClinicalTrials.gov and Cochrane databases were systematically reviewed for randomized-controlled trials comparing anastrozole with tamoxifen in the adjuvant treatment of early breast cancer. Results The combined hazard rate of 4 trials for event-free survival (EFS was 0.77 (95%CI: 0.70–0.85 (P P P Conclusion Anastrozole appears to have superior efficacy than tamoxifen in the adjuvant hormonal treatment of early breast cancer. Until further clinical evidence comes up, aromatase inhibitors should be the initial hormonal therapy in postmenopausal early breast cancer patients and switching should only be considered for patients who are currently receiving tamoxifen.

  6. Comparative Effectiveness of Chewing Stick and Toothbrush: A Randomized Clinical Trial

    Science.gov (United States)

    Malik, Aeeza S; Shaukat, Malik S; Qureshi, Ambrina A; Abdur, Rasheed

    2014-01-01

    Background: With the increasing rate of oral diseases, the global necessity of effective and economical products for its prevention and treatment has intensified. Aim: This study was to compare the effectiveness of two oral hygiene aids: Chewing stick and manual toothbrush, for plaque removal and gingival health after one month of a randomized clinical trial. Materials and Methods: Dental students (age 18-22 years) of a public sector dental hospital were recruited. Sample size was determined using the American Dental Association guidelines. Participants were randomized into two interventional groups and provided with either chewing sticks or toothbrushes. Pre- and post-intervention examinations were executed by two blind and calibrated examiners using plaque and gingival dental indices. Statistical analysis included descriptive statistics, paired t-test, and two sample independent t-tests. Results: Fifty subjects were recruited with mean age 20 ± 0.66 years (80% were females and 20% were males). Except for the mean plaque scores of toothbrush users (which increased at post-intervention examination), all other scores showed reduction. In contrast to the final mean gingival scores, a significant difference (P = toothbrush. PMID:25077082

  7. A randomized trial comparing TVT with TVT-O: 12-month results.

    Science.gov (United States)

    Rinne, Kirsi; Laurikainen, Eija; Kivelä, Arre; Aukee, Pauliina; Takala, Teuvo; Valpas, Antti; Nilsson, Carl Gustaf

    2008-08-01

    The aim of this randomized clinical trial was to compare the cure rate and the rate of complications of the tension-free vaginal tape (TVT) with those of the tension free vaginal tape obturator (TVT-O) procedure after one year of follow-up. The study was powered to show a ten per cent difference in cure rate and/or rate of complications. Of the initially treated 267 women 134 in the TVT group and 131 in the TVT-O group were evaluated. A cough stress test and a 24 h pad test were used as objective outcome measures. Subjective outcome was assessed by different condition-specific quality of life questionnaires and general health by the EQ-5D questionnaire. Objective cure rate was 95.5% in the TVT patients and 93.1% in TVT-O patients. Subjective cure rates showed significant improvement at one the year follow up in both groups. No significant differences in cure rates between groups were seen. The complication rate was equal in both groups.

  8. Troxipide in the Management of Gastritis: A Randomized Comparative Trial in General Practice

    Directory of Open Access Journals (Sweden)

    Bhupesh Dewan

    2010-01-01

    Full Text Available Background. A trial of empirical acid-suppressive therapy is the usual practice for most patients with symptoms of gastritis in primary care. Aim. To assess the relative efficacy of Troxipide and Ranitidine in patients with endoscopic gastritis over a four-week period. Methods. In all, 142 patients were randomized to Troxipide (100 mg tid or Ranitidine (150 mg bid for a period of four weeks. The severity of the signs of endoscopic gastritis at baseline and week 4 using a four-point scale and the subjective symptom severity at baseline and week 2 & week 4 using a Visual analog scale (VAS were documented. Results. Troxipide was found to be superior to Ranitidine for both, the complete resolution and improvement of endoscopic gastritis. Higher proportion of patients showed complete healing of erosions (88.14%, oozing (96.77%, and edema (93.88% with Troxipide as compared to Ranitidine (<.01. Patients receiving Troxipide also showed a greater improvement in the VAS scores for abdominal pain, bloating, and heartburn (<.01. Both the drugs were found to be well tolerated. Conclusion. In patients with endoscopic gastritis, Troxipide, with its superior rate of improvement, resolution of signs, and subjective clinical symptoms, can be considered as an alternative to the commonly used antisecretory agents.

  9. A Randomized Controlled Trial Comparing the Letter Project Advance Directive to Traditional Advance Directive.

    Science.gov (United States)

    Periyakoil, Vyjeyanthi S; Neri, Eric; Kraemer, Helena

    2017-09-01

    Simpler alternatives to traditional advance directives that are easy to understand and available in multiple formats and can be initiated by patients and families will help facilitate advance care planning. The goal of this study was to compare the acceptability of the letter advance directive (LAD) to the traditional advance directive (TAD) of the state of California. A web-based, randomized controlled trial was conducted, in which the participants were randomized to one of two types of advance directives (ADs): the LAD (intervention) or the TAD (control). Primary outcomes were participant ratings of the ease, value, and their level of comfort in the AD document they completed. A total of 400 participants completed the study, with 216 randomized to the LAD and 184 to the TAD by a computerized algorithm. Overall, participants preferred the LAD to the TAD (success rate difference [SRD] = 0.46, 95th percentile confidence interval [CI]: 0.36-0.56, p end of life (SRD = 0.32, CI: 0.23-0.42, p end-of-life treatment preferences. Patients reported the letter advance directive to be a better alternative to the traditional advance directive form.

  10. Cutaneous fungal microbiome:Malasseziayeasts in seborrheic dermatitis scalp in a randomized, comparative and therapeutic trial.

    Science.gov (United States)

    Kamamoto, C S L; Nishikaku, A S; Gompertz, O F; Melo, A S; Hassun, K M; Bagatin, E

    2017-01-01

    Malassezia spp in skin microbiome scalp has been implicated in seborrheic dermatitis pathogenesis. Thus, treatment based in antifungal combined to topical keratolitic agents have been indicated as well as oral isotretinoin as it reduces the sebum production, glandular's size and possesses anti-inflammatory properties. This randomized, comparative and therapeutic trial aimed toper form the genotypic identification of Malassezia species before and after low-dose oral isotretinoin or topical antifungal treatments for moderate to severe seborrhea and/or seborrheic dermatitis on scalp. Scales and sebum of the scalp were seeded in the middle of modified Dixon and incubated at 32°C. For genotypic identification polymerase chain reaction primers for the ITS and D1/D2 ribossomal DNA were used and followed by samples sequencing. The procedure was conducted before and after therapeutic and randomized intervention for moderate to severe seborrhea/seborrheic dermatitis on the scalp, including oral isotretinoin, 10 mg, every other day and anti-seborrheic shampoo (piroctone olamine), over six months. The M. globosa and M. restricta were the most frequent species isolated on the scalp before and after both treatments. Other non- Malassezia species were also identified. The Malassezia spp. were maintained in the scalp after both treatments that were equally effective for the control of seborrhea/seborrheic dermatitis clinical signs.

  11. [Tenoxicam (texamen) in the treatment of acute cervicalgia: results of an open comparative trial].

    Science.gov (United States)

    Azimova, Iu E; Tabeeva, G R

    2014-01-01

    Acute cervical pain is one of the most common reasons for a visit to a doctor and temporal disability. We studied efficacy and safety of the nonsteroid anti-inflammatory drug tenoxicam (texamen) in the treatment of acute cervical pain in myofascial syndrome. A trial included 50 people (42 women and 8 men, mean age 42,2±6,8 years) with acute cephalgia. A main group (30 patients) received tenoxicam in dose 20 mg daily in the morning during 7 days with simultaneous therapeutic exercises with elements of postisometric relaxation of cervical muscles. A control group (20 patients) received myorelaxants and massage of a cervical-collar zone. The analgesic effect was more rapid in patients treated with texamen compared to controls. Statistically significant differences were seen in 1-3 days of treatment. In the main group, the analgesic effect long, only 16,6% of patients reported the aggravation of pain in the evening hours during the first day of treatment and 10% in the 2nd day; 23,3% patients of the main group used an additional dose of texamen, another nonsteroid anti-inflammatory drug (ibuprofen) or triptan to stop pain. The introduction of nonsteroid anti-inflammatory drugs, in particular texamen, in the complex treatment of acute cephalgia can significantly reduce pain syndrome.

  12. Explaining feast or famine in randomized field trials. Medical science and criminology compared.

    Science.gov (United States)

    Shepherd, Jonathan P

    2003-06-01

    A feast of randomized controlled trials (RCTs) in medical science and comparative famine in criminology can be explained in terms of cultural and structural factors. Of central importance is the context in which the evaluation of interventions is done and the difference in status of situational research in the two disciplines. Evaluation of medical interventions has traditionally been led by practitioner (clinical) academics. This is not the case in criminal justice, where theory has had higher status than intervention research. Medical science has advanced in, or closely associated with, university teaching hospitals, but links between criminology and criminal justice services are far more tenuous. The late development of situational crime prevention seems extraordinary from a medical perspective, as does the absence of university police schools in the United Kingdom and elsewhere. These structural and cultural factors explain concentration of expectation, resource, and RCT productivity in medical science. The Campbell Collaboration and the Academy of Experimental Criminology are forces which are reducing this polarization of feast and famine in RCTs. But unless scientific criminology is embedded in university schools which are responsible for the education and training of law, probation, and police practitioners, convergence in terms of RCTs and implementation of findings in practice seems unlikely.

  13. A randomized comparative effectiveness trial of using cable television to deliver diabetes prevention programming

    Science.gov (United States)

    Ackermann, Ronald T; Sandy, Lewis G; Beauregard, Tom; Coblitz, Mark; Norton, Kristi L; Vojta, Deneen

    2014-01-01

    Objective To evaluate the use and effectiveness of two “in-home” strategies for delivering diabetes prevention programming using cable television. Methods An individually randomized, two-arm intervention trial including adults with diabetes risk factors living in two US cities. Interventions involved a 16-session lifestyle intervention delivered via “video-on-demand” cable television, offered alone versus in combination with web-based lifestyle support tools. Repeated measures longitudinal linear regression with imputation of missing observations was used to compare changes in body weight. Results A total of 306 individuals were randomized and offered the interventions. After 5 months, 265 (87%) participants viewed at least 1, and 110 (36%) viewed ≥9 of the video episodes. A total of 262 (86%) participants completed a 5-month weight measurement. In intention-to-treat analysis with imputation of missing observations, mean weight loss at 5 months for both treatment groups combined was 3.3% (95% CI 0.7-5.0%), regardless of intervention participation (with no differences between randomized groups (P = 0.19)), and was 4.9% (95% CI 2.1-6.5%) for participants who viewed ≥9 episodes. Conclusions In-home delivery of evidence-based diabetes prevention programming in a reality television format, offered with or without online behavioral support tools, can achieve modest weight losses consistent with past implementation studies of face-to-face programs using similar content. PMID:24740868

  14. Exercise augmentation compared with usual care for post-traumatic stress disorder: a randomized controlled trial.

    Science.gov (United States)

    Rosenbaum, S; Sherrington, C; Tiedemann, A

    2015-05-01

    To investigate the impact of a 12-week exercise programme in addition to usual care for post-traumatic stress disorder (PTSD). An assessor-blinded randomized controlled trial was conducted among 81 participants with a DSM-IV-TR diagnosis of primary PTSD. Participants were recruited after admission to an in-patient programme at a private hospital. Participants were randomized to receive either usual care (n=42), or exercise in addition to usual care (n=39). The exercise intervention involved three, 30-min resistance-training sessions/week and a pedometer-based walking programme. Usual care involved psychotherapy, pharmaceutical interventions, and group therapy. Primary outcome was PTSD symptoms assessed via the PTSD checklist-civilian version (PCL-C). Secondary outcomes included symptoms of depression, anthropometry, physical activity, mobility, strength, and sleep quality. Participants had a mean (SD) age of 47.8 years (12.1), 84% male. PTSD symptoms in the intervention group significantly reduced compared with the usual care group (mean difference=-5.4, 95% CI -10.5 to -0.3, P=0.04, n=58). There were significant between-group differences at follow-up for depressive symptoms, waist circumference, sleep quality, and sedentary time. This study provides the first evidence that an exercise intervention is associated with reduced PTSD and depressive symptoms, reduced waist circumference, and improved sleep quality. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  15. Randomized trial comparing mindfulness training for smokers to a matched control

    Science.gov (United States)

    Davis, James M.; Manley, Alison R.; Goldberg, Simon B.; Smith, Stevens S.; Jorenby, Douglas E.

    2014-01-01

    Smoking continues to take an enormous toll on society, and although most smokers would like to quit, most are unsuccessful using existing therapies. These findings call on researchers to develop and test therapies that provide higher rates of long-term smoking abstinence. We report results of a randomized controlled trial comparing a novel smoking cessation treatment using mindfulness training to a matched control based on the American Lung Association's Freedom From Smoking program. Data were collected on 175 low socioeconomic status smokers in 2011-2012 in a medium sized Midwestern city. A significant difference was not found in the primary outcome; intent-to-treat biochemically confirmed 6-month smoking abstinence rates were Mindfulness = 25.0%, Control= 17.9% (p = 0.35). Differences favoring the mindfulness condition were found on measures of urges and changes in mindfulness, perceived stress, and experiential avoidance. While no significant differences were found in quit rates, the mindfulness intervention resulted in positive outcomes. PMID:24957302

  16. Randomized Clinical Trial Comparing Low DensityversusHigh Density Meshes in Patients with Bilateral Inguinal Hernia.

    Science.gov (United States)

    Carro, Jose Luis Porrero; Riu, Sol Villar; Lojo, Beatriz Ramos; Latorre, Lucia; Garcia, Maria Teresa Alonso; Pardo, Benito Alcaide; Naranjo, Oscar Bonachia; Herrero, Alberto Marcos; Cabezudo, Carlos Sanchez; Herreras, Esther Quiros

    2017-12-01

    We present a randomized clinical trial to compare postoperative pain, complications, feeling of a foreign body, and recurrence between heavyweight and lightweight meshes in patients with bilateral groin hernia. Sixty-seven patients with bilateral hernia were included in our study. In each patient, the side of the lightweight mesh was decided by random numbers table. Pain score was measured by visual analogue scale, on 1st, 3rd, 5th, and 7th postoperative day, and one year after the surgery. There were no statistically significative differences between both meshes in postoperative complications. About differences of pain average, there were statistically significant differences only on the 1st postoperative day (P <0.01) and the 7th postoperative day (P <0.05). In the review after a year, there were no statistically significative differences in any parameter. In our study, we did not find statistically significative differences between lightweight and heavyweight meshes in postoperative pain, complications, feeling of a foreign body, and recurrence, except pain on 1st and 7th postoperative day.

  17. Effect of tai chi versus aerobic exercise for fibromyalgia: comparative effectiveness randomized controlled trial.

    Science.gov (United States)

    Wang, Chenchen; Schmid, Christopher H; Fielding, Roger A; Harvey, William F; Reid, Kieran F; Price, Lori Lyn; Driban, Jeffrey B; Kalish, Robert; Rones, Ramel; McAlindon, Timothy

    2018-03-21

    To determine the effectiveness of tai chi interventions compared with aerobic exercise, a current core standard treatment in patients with fibromyalgia, and to test whether the effectiveness of tai chi depends on its dosage or duration. Prospective, randomized, 52 week, single blind comparative effectiveness trial. Urban tertiary care academic hospital in the United States between March 2012 and September 2016. 226 adults with fibromyalgia (as defined by the American College of Rheumatology 1990 and 2010 criteria) were included in the intention to treat analyses: 151 were assigned to one of four tai chi groups and 75 to an aerobic exercise group. Participants were randomly assigned to either supervised aerobic exercise (24 weeks, twice weekly) or one of four classic Yang style supervised tai chi interventions (12 or 24 weeks, once or twice weekly). Participants were followed for 52 weeks. Adherence was rigorously encouraged in person and by telephone. The primary outcome was change in the revised fibromyalgia impact questionnaire (FIQR) scores at 24 weeks compared with baseline. Secondary outcomes included changes of scores in patient's global assessment, anxiety, depression, self efficacy, coping strategies, physical functional performance, functional limitation, sleep, and health related quality of life. FIQR scores improved in all five treatment groups, but the combined tai chi groups improved statistically significantly more than the aerobic exercise group in FIQR scores at 24 weeks (difference between groups=5.5 points, 95% confidence interval 0.6 to 10.4, P=0.03) and several secondary outcomes (patient's global assessment=0.9 points, 0.3 to 1.4, P=0.005; anxiety=1.2 points, 0.3 to 2.1, P=0.006; self efficacy=1.0 points, 0.5 to 1.6, P=0.0004; and coping strategies, 2.6 points, 0.8 to 4.3, P=0.005). Tai chi treatment compared with aerobic exercise administered with the same intensity and duration (24 weeks, twice weekly) had greater benefit (between group

  18. End-tidal control vs. manually controlled minimal-flow anesthesia: a prospective comparative trial.

    Science.gov (United States)

    Wetz, A J; Mueller, M M; Walliser, K; Foest, C; Wand, S; Brandes, I F; Waeschle, R M; Bauer, M

    2017-11-01

    To ensure safe general anesthesia, manually controlled anesthesia requires constant monitoring and numerous manual adjustments of the gas dosage, especially for low- and minimal-flow anesthesia. Oxygen flow-rate and administration of volatile anesthetics can also be controlled automatically by anesthesia machines using the end-tidal control technique, which ensures constant end-tidal concentrations of oxygen and anesthetic gas via feedback and continuous adjustment mechanisms. We investigated the hypothesis that end-tidal control is superior to manually controlled minimal-flow anesthesia (0.5 l/min). In this prospective trial, we included 64 patients undergoing elective surgery under general anesthesia. We analyzed the precision of maintenance of the sevoflurane concentration (1.2-1.4%) and expiratory oxygen (35-40%) and the number of necessary adjustments. Target-concentrations of sevoflurane and oxygen were maintained at more stable levels with the use of end-tidal control (during the first 15 min 28% vs. 51% and from 15 to 60 min 1% vs. 19% deviation from sevoflurane target, P tidal oxygen (5, IQR 3-6). The target-concentrations were reached earlier with the use of end-tidal compared with manual controlled minimal-flow anesthesia but required slightly greater use of anesthetic agents (6.9 vs. 6.0 ml/h). End-tidal control is a superior technique for setting and maintaining oxygen and anesthetic gas concentrations in a stable and rapid manner compared with manual control. Consequently, end-tidal control can effectively support the anesthetist. © 2017 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

  19. Randomized controlled trial comparing aerosolized swallowed fluticasone to esomeprazole for esophageal eosinophilia.

    Science.gov (United States)

    Moawad, Fouad J; Veerappan, Ganesh R; Dias, Johnny A; Baker, Thomas P; Maydonovitch, Corinne L; Wong, Roy K H

    2013-03-01

    Patients with clinical symptoms of esophageal dysfunction and dense eosinophilic infiltration of the esophageal mucosa are suspected to have eosinophilic esophagitis (EoE). Topical steroids are often used as first-line therapy for EoE, although some patients respond clinically to proton pump inhibitors (PPIs). The purpose of this study was to compare the histological and clinical response of patients with esophageal eosinophilia treated with aerosolized swallowed fluticasone propionate vs. esomeprazole. This prospective single-blinded randomized controlled trial enrolled newly diagnosed patients with suspected EoE, defined as having clinical symptoms related to esophageal dysfunction with at least 15 eosinophils/high power field (hpf). Patients underwent 24-h pH/impedance monitoring to establish gastroesophageal reflux disease (GERD). Patients were stratified by the presence of GERD and randomized to receive fluticasone 440 mcg twice daily or esomeprazole 40 mg once daily for 8 weeks followed by repeat endoscopy with biopsies. The primary outcome was histological response of esophageal eosinophilia, defined as esomeprazole (n = 21) treatment arms. In all, 19% (8/42) of patients had coexisting GERD and were equally stratified into each arm (n = 4). Overall, there was no significant difference in resolution of esophageal eosinophilia between fluticasone and esomeprazole (19 vs. 33%, P = 0.484). In patients with established GERD, resolution of esophageal eosinophilia was noted in 0% (0/4) of the fluticasone group compared with 100% (4/4) of the esomeprazole group (P = 0.029). In GERD-negative patients, there was no significant difference in resolution of esophageal eosinophilia between treatment arms with fluticasone and esomeprazole (24 vs.18%, P = 1.00). The MDQ score significantly decreased after treatment with esomeprazole (19 ± 21 vs. 1.4 ± 4.5, Pesomeprazole provide a similar histological response for esophageal eosinophilia. With regard to clinical response

  20. A randomized comparative trial in the management of Alcohol Dependence: Individualized Homoeopathy versus standard Allopathic Treatment

    Directory of Open Access Journals (Sweden)

    Raj K Manchanda

    2016-01-01

    Full Text Available Objectives: This study was undertaken to compare the effects of IH with standard allopathic (SA treatment. Methods: A randomized controlled, open-label, comparative trial, was conducted, in which alcohol dependents were screened verbally using the CAGE scale. The participants 80 patients fulfilling the inclusion criteria were randomized either IH (n=40 or SA (n=40 and treated cum followed up for 12 months. The primary outcome was more than 50% reduction in the Severity of Alcohol Dependence Questionnaire [SADQ] rating scale at 12 th month. Data analysis was done for both intention-to-treat (ITT and per-protocol (PP populations. Results: ITT analysis reflected 80% (n = 32 of the patients in IH and 37.5% (n = 15 of the patients in the SA responding to CI before 2.4 treatment with absolute difference was 42.5% (42.5 [95% confidence interval [CI]: 23.0, 61.6] and estimated effect: 6.6 (95% C.I: 2.4, 18.2, P = 0.0002. A significant difference favoring IH was also observed in three out of four domains of WHO QOL-BREF. Statistically significant difference was found in the number of drinking days (median difference: −24.00; CI: −39.0-−8.0; P = 0.001 and number of drinks per drinking day (median difference: −6.3 [95% CI: −11.3-−1.9]; P = 0.004, favoring IH. The results showed a similar trend in PP analysis. Medicines found useful were Sulphur, Lycopodium clavatum, Arsenicum album, Nux vomica, Phosphorus, and Lachesis. Conclusion: The results conclude that IH is not inferior to SA in the management of AD patients. More rigorous studies with large sample size are however desirable.

  1. CYberinfrastructure for COmparative effectiveness REsearch (CYCORE): improving data from cancer clinical trials.

    Science.gov (United States)

    Patrick, Kevin; Wolszon, Laura; Basen-Engquist, Karen M; Demark-Wahnefried, Wendy; Prokhorov, Alex V; Barrera, Stephanie; Baru, Chaitan; Farcas, Emilia; Krueger, Ingolf; Palmer, Doug; Raab, Fred; Rios, Phil; Ziftci, Celal; Peterson, Susan

    2011-03-01

    Improved approaches and methodologies are needed to conduct comparative effectiveness research (CER) in oncology. While cancer therapies continue to emerge at a rapid pace, the review, synthesis, and dissemination of evidence-based interventions across clinical trials lag in comparison. Rigorous and systematic testing of competing therapies has been clouded by age-old problems: poor patient adherence, inability to objectively measure the environmental influences on health, lack of knowledge about patients' lifestyle behaviors that may affect cancer's progression and recurrence, and limited ability to compile and interpret the wide range of variables that must be considered in the cancer treatment. This lack of data integration limits the potential for patients and clinicians to engage in fully informed decision-making regarding cancer prevention, treatment, and survivorship care, and the translation of research results into mainstream medical care. Particularly important, as noted in a 2009 report on CER to the President and Congress, the limited focus on health behavior-change interventions was a major hindrance in this research landscape (DHHS 2009). This paper describes an initiative to improve CER for cancer by addressing several of these limitations. The Cyberinfrastructure for Comparative Effectiveness Research (CYCORE) project, informed by the National Science Foundation's 2007 report "Cyberinfrastructure Vision for 21(st) Century Discovery" has, as its central aim, the creation of a prototype for a user-friendly, open-source cyberinfrastructure (CI) that supports acquisition, storage, visualization, analysis, and sharing of data important for cancer-related CER. Although still under development, the process of gathering requirements for CYCORE has revealed new ways in which CI design can significantly improve the collection and analysis of a wide variety of data types, and has resulted in new and important partnerships among cancer researchers engaged in

  2. Data extraction from machine-translated versus original language randomized trial reports: a comparative study.

    Science.gov (United States)

    Balk, Ethan M; Chung, Mei; Chen, Minghua L; Chang, Lina Kong Win; Trikalinos, Thomas A

    2013-11-07

    Google Translate offers free Web-based translation, but it is unknown whether its translation accuracy is sufficient to use in systematic reviews to mitigate concerns about language bias. We compared data extraction from non-English language studies with extraction from translations by Google Translate of 10 studies in each of five languages (Chinese, French, German, Japanese and Spanish). Fluent speakers double-extracted original-language articles. Researchers who did not speak the given language double-extracted translated articles along with 10 additional English language trials. Using the original language extractions as a gold standard, we estimated the probability and odds ratio of correctly extracting items from translated articles compared with English, adjusting for reviewer and language. Translation required about 30 minutes per article and extraction of translated articles required additional extraction time. The likelihood of correct extractions was greater for study design and intervention domain items than for outcome descriptions and, particularly, study results. Translated Spanish articles yielded the highest percentage of items (93%) that were correctly extracted more than half the time (followed by German and Japanese 89%, French 85%, and Chinese 78%) but Chinese articles yielded the highest percentage of items (41%) that were correctly extracted >98% of the time (followed by Spanish 30%, French 26%, German 22%, and Japanese 19%). In general, extractors' confidence in translations was not associated with their accuracy. Translation by Google Translate generally required few resources. Based on our analysis of translations from five languages, using machine translation has the potential to reduce language bias in systematic reviews; however, pending additional empirical data, reviewers should be cautious about using translated data. There remains a trade-off between completeness of systematic reviews (including all available studies) and risk of

  3. Stool management systems for preventing environmental spread of Clostridium difficile: a comparative trial.

    Science.gov (United States)

    Gray, Mikel; Omar, Amin; Buziak, Brenton

    2014-01-01

    The purpose of this study was to compare contamination of the immediate environment with Clostridium difficile spores and vegetative cells from 2 stool management systems over a period of 30 days in a controlled laboratory setting. In vitro, comparison trial. Two stool management systems were compared over a 30-day period in a controlled laboratory setting. Sixteen systems were filled with sterile loose canine stool inoculated with 10 colony-forming units (CFUs) per milliliter of C difficile; specially prepared culture media were used to detect C difficile contamination on various surfaces of the device and in the immediate environment. Containment bags were changed daily and devices were refilled with inoculated stool to more closely imitate use in the clinical setting. A dichotomous outcome variable (growth vs no growth) was used to analyze contamination on a daily basis via the generalized estimating equation; devices were also compared on days 3, 10, 20, and 30 by measuring CFUs per device surface. Logistic regression analysis was used to analyze growth over time. When observations showed no growth, the Cochran-Mantel Haenszel test was used to compare study devices. Analysis revealed that 20.8% of anterior surfaces of the collection bags for device 1 were contaminated versus 83.9% of collection bags for device 2 (P < .001). Comparison of the tubing/hub interface resulted in similar findings; 20.8% of device 1 group were contaminated versus 86.3% of device 2 group (P < .001). Analysis of an absorbent pad placed under the device during daily changes found that 0.5% of device 1 were contaminated versus 38.1% of pads placed under device 2 (P < .001). Findings from this in vitro study show that stool management systems can limit or prevent environmental contamination of C difficile. Results also reveal significant differences in the 2 systems tested; we hypothesize that these differences are attributable to the interface between the tubing and collection bag, the

  4. The IDvIP trial: a two-centre randomised double-blind controlled trial comparing intramuscular diamorphine and intramuscular pethidine for labour analgesia.

    Science.gov (United States)

    Wee, Michael Y K; Tuckey, Jenny P; Thomas, Peter; Burnard, Sara

    2011-07-08

    Intramuscular pethidine is routinely used throughout the UK for labour analgesia. Studies have suggested that pethidine provides little pain relief in labour and has a number of side effects affecting mother and neonate. It can cause nausea, vomiting and dysphoria in mothers and can cause reduced fetal heart rate variability and accelerations. Neonatal effects include respiratory depression and impaired feeding. There are few large studies comparing the relative side effects and efficacy of different opioids in labour. A small trial comparing intramuscular pethidine with diamorphine, showed diamorphine to have some benefits over pethidine when used for labour analgesia but the study did not investigate the adverse effects of either opioid. The Intramuscular Diamorphine versus Intramuscular Pethidine (IDvIP) trial is a randomised double-blind two centre controlled trial comparing intramuscular diamorphine and pethidine regarding their analgesic efficacy in labour and their side effects in mother, fetus and neonate. Information about the trial will be provided to women in the antenatal period or in early labour. Consent and recruitment to the trial will be obtained when the mother requests opioid analgesia. The sample size requirement is 406 women with data on primary outcomes. The maternal primary outcomes are pain relief during the first 3 hours after trial analgesia and specifically pain relief after 60 minutes. The neonatal primary outcomes are need for resuscitation and Apgar Score analgesia, whether method of analgesia would be used again, use of Entonox, umbilical arterial and venous pH, fetal heart rate, meconium staining, time from delivery to first breath, Apgar scores at 5 mins, naloxone requirement, transfer to neonatal intensive care unit, neonatal haemoglobin oxygen saturation at 30, 60, 90, and 120 mins after delivery, and neonatal sedation and feeding behaviour during first 2 hours. If the trial demonstrates that diamorphine provides better analgesia

  5. Comparing cluster-level dynamic treatment regimens using sequential, multiple assignment, randomized trials: Regression estimation and sample size considerations.

    Science.gov (United States)

    NeCamp, Timothy; Kilbourne, Amy; Almirall, Daniel

    2017-08-01

    Cluster-level dynamic treatment regimens can be used to guide sequential treatment decision-making at the cluster level in order to improve outcomes at the individual or patient-level. In a cluster-level dynamic treatment regimen, the treatment is potentially adapted and re-adapted over time based on changes in the cluster that could be impacted by prior intervention, including aggregate measures of the individuals or patients that compose it. Cluster-randomized sequential multiple assignment randomized trials can be used to answer multiple open questions preventing scientists from developing high-quality cluster-level dynamic treatment regimens. In a cluster-randomized sequential multiple assignment randomized trial, sequential randomizations occur at the cluster level and outcomes are observed at the individual level. This manuscript makes two contributions to the design and analysis of cluster-randomized sequential multiple assignment randomized trials. First, a weighted least squares regression approach is proposed for comparing the mean of a patient-level outcome between the cluster-level dynamic treatment regimens embedded in a sequential multiple assignment randomized trial. The regression approach facilitates the use of baseline covariates which is often critical in the analysis of cluster-level trials. Second, sample size calculators are derived for two common cluster-randomized sequential multiple assignment randomized trial designs for use when the primary aim is a between-dynamic treatment regimen comparison of the mean of a continuous patient-level outcome. The methods are motivated by the Adaptive Implementation of Effective Programs Trial which is, to our knowledge, the first-ever cluster-randomized sequential multiple assignment randomized trial in psychiatry.

  6. A Randomized Trial Comparing Cardiac Rehabilitation to Standard of Care for Adults With Congenital Heart Disease.

    Science.gov (United States)

    Opotowsky, Alexander R; Rhodes, Jonathan; Landzberg, Michael J; Bhatt, Ami B; Shafer, Keri M; Yeh, Doreen DeFaria; Crouter, Scott E; Ubeda Tikkanen, Ana

    2018-03-01

    Cardiac rehabilitation (CR) improves exercise capacity and quality of life while reducing mortality in adults with acquired heart disease. Cardiac rehabilitation has not been extensively studied in adults with congenital heart disease (CHD). We performed a prospective, randomized controlled trial (NCT01822769) of a 12-week clinical CR program compared with standard of care (SOC). Participants were ≥16 years old, had moderate or severe CHD, had O 2 saturation ≥92%, and had peak O 2 consumption ([Formula: see text]) exercise capacity, physical activity, quality of life, self-reported health status, and other variables at baseline and after 12 weeks. The prespecified primary end point was change in [Formula: see text]. We analyzed data on 28 participants (aged 41.1 ± 12.1 years, 50% male), 13 randomized to CR and 15 to SOC. [Formula: see text] averaged 16.8 ± 3.8 mL/kg/min, peak work rate = 95 ± 28 W, and median Minnesota Living with Heart Failure Questionnaire (MLHFQ) score = 27 (interquartile range: 11-44). Cardiac rehabilitation participants were older (48 ± 9 years vs 36 ± 12 years; P = .01), but there were no significant between-group differences in other variables. There were no adverse events related to CR. [Formula: see text] increased in the CR group compared with SOC (+2.2 mL/kg/min, 95% confidence interval: 0.7-3.7; P = .002, age-adjusted +2.7 mL/kg/min; P = .004); there was a nonsignificant improvement in work rate (+8.1 W; P = .13). Among the 25 participants with baseline MLHFQ > 5, there was a clinically important >5-point improvement in 72.7% and 28.6% of CR and SOC participants, respectively ( P = .047). Cardiac rehabilitation was also associated with improved self-assessment of overall health ( P Cardiac rehabilitation is safe and is associated with improvement in aerobic capacity and self-reported health status compared with SOC in adults with CHD.

  7. Randomised, controlled trial of alternating pressure mattresses compared with alternating pressure overlays for the prevention of pressure ulcers: PRESSURE (pressure relieving support surfaces) trial

    OpenAIRE

    2006-01-01

    Objective To compare whether differences exist between alternating pressure overlays and alternating pressure mattresses in the development of new pressure ulcers, healing of existing pressure ulcers, and patient acceptability. Design Pragmatic, open, multicentre, randomised controlled trial. Setting 11 hospitals in six NHS trusts. Participants 1972 people admitted to hospital as acute or elective patients. Interventions Participants were randomised to an alternating pressure mattress (n = 98...

  8. Pharmacy Diabetes Screening Trial: protocol for a pragmatic cluster-randomised controlled trial to compare three screening methods for undiagnosed type 2 diabetes in Australian community pharmacy

    OpenAIRE

    Krass, Ines; Carter, Rob; Mitchell, Bernadette; Mohebbi, Mohammadreza; Shih, Sophy T F; Trinder, Peta; Versace, Vincent L; Wilson, Frances; Namara, Kevin Mc

    2017-01-01

    Introduction With the rising prevalence of type 2 diabetes in Australia, screening and earlier diagnosis is needed to provide opportunities to intervene with evidence-based lifestyle and treatment options to reduce the individual, social and economic impact of the disease. The objectives of the Pharmacy Diabetes Screening Trial are to compare the clinical effectiveness and cost-effectiveness of three screening models for type 2 diabetes in a previously undiagnosed population. Methods and anal...

  9. Study design considerations in a large COPD trial comparing effects of tiotropium with salmeterol on exacerbations

    NARCIS (Netherlands)

    K-M. Beeh (Kai-Michael); B. Hederer (Bettina); T. Glaab (Thomas); A. Müller (Achim); M.P.M.H. Rutten-van Mölken (Maureen); S. Kesten (Steven); C. Vogelmeier (Claus)

    2009-01-01

    textabstractAbstract Currently available long-acting inhaled bronchodilators (tiotropium, salmeterol, formoterol) have demonstrated beneficial effects on exacerbations in placebo-controlled trials. However, there have been no direct comparisons of these drugs with exacerbations as the primary

  10. Randomised trial of single and repeated fibrin glue compared with injection of polidocanol in treatment of bleeding peptic ulcer

    NARCIS (Netherlands)

    Rutgeerts, P.; Rauws, E.; Wara, P.; Swain, P.; Hoos, A.; Solleder, E.; Halttunen, J.; Dobrilla, G.; Richter, G.; Prassler, R.

    1997-01-01

    Although injection treatments for ulcer haemostasis seem to be effective, recurrent bleeding remains a serious problem. Large randomised clinical trials are required to show differences between treatment modalities for gastrointestinal bleeding. The aim of this study was to compare the safety and

  11. Cost utility analysis of co-prescribed heroin compared with methadone maintenance treatment in heroin addicts in two randomised trials

    NARCIS (Netherlands)

    Dijkgraaf, Marcel G. W.; van der Zanden, Bart P.; de Borgie, Corianne A. J. M.; Blanken, Peter; van Ree, Jan M.; van den Brink, Wim

    2005-01-01

    Objective To determine the cost utility of medical co-prescription of heroin compared with methadone maintenance treatment for chronic, treatment resistant heroin addicts. Design Cost utility analysis of two pooled open label randomised controlled trials. Setting Methadone maintenance programmes in

  12. A multicenter, randomized trial comparing synthetic surfactant with modified bovine surfactant extract in the treatment of neonatal respiratory distress syndrome

    NARCIS (Netherlands)

    Adams, E; Vollman, J; Giebner, D; Maurer, M; Dreyer, G; Bailey, L; Anderson, M; Mefford, L; Beaumont, E; Sutton, D; Puppala, B; Mangurten, HH; Secrest, J; Lewis, WJ; Carteaux, P; Bednarek, F; Welsberger, S; Gosselin, R; Pantoja, AF; Belenky, A; Campbell, P; Patole, S; Duenas, M; Kelly, M; Alejo, W; Lewallen, P; DeanLieber, S; Hanft, M; Ferlauto, J; Newell, RW; Bagwell, J; Levine, D; Lipp, RW; Harkavy, K; Vasa, R; Birenbaum, H; Broderick, KA; Santos, AQ; Long, BA; Gulrajani, M; Stern, M; Hopgood, G; Hegyi, T; Alba, J; Christmas, L; McQueen, M; Nichols, N; Brown, M; Quissell, BJ; Rusk, C; Marks, K; Gifford, K; Hoehn, G; Pathak, A; Marino, B; Hunt, P; Fox, [No Value; Sharpstein, C; Feldman, B; Johnson, N; Beecham, J; Balcom, R; Helmuth, W; Boylan, D; Frakes, C; Magoon, M; Reese, K; Schwersenski, J; Schutzman, D; Soll, R; Horbar, JD; Leahy, K; Troyer, W; Juzwicki, C; Anderson, P; Dworsky, M; Reynolds, L; Urrutia, J; Gupta, U; Adray, C

    Objective. To compare the efficacy of a synthetic surfactant (Exosurf Neonatal, Burroughs-Wellcome Co) and a modified bovine surfactant extract (Survanta, Ross Laboratories) in the treatment of neonatal respiratory distress syndrome (RDS). Design. Multicenter, randomized trial. Setting. Thirty-eight

  13. Open comparative trial of formestane versus megestrol acetate in postmenopausal patients with advanced breast cancer previously treated with tamoxifen

    NARCIS (Netherlands)

    Freue, M; Kjaer, M; Boni, C; Joliver, J; Janicke, F; Willemse, PHB; Coombes, RC; Van Belle, S; Perez-Carrion, R; Zieschang, J; de Palacios, PI; Rose, C

    The aim of the trial was to compare efficacy and safety of the aromatase inhibitor formestane (250 mg i.m. given every 2 weeks) with the progestin megestrol acetate (160 mg administered orally once daily), as second-line therapy in postmenopausal patients with advanced breast cancer previously

  14. Comparing cost effects of two quality strategies to improve test ordering in primary care: a randomized trial.

    NARCIS (Netherlands)

    Verstappen, W.H.; Merode, F. van; Grimshaw, J.; Dubois, W.; Grol, R.P.T.M.; Weijden, T. van der

    2004-01-01

    OBJECTIVE: To determine the costs and cost reductions of an innovative strategy aimed at improving test ordering routines of primary care physicians, compared with a traditional strategy. DESIGN: Multicenter randomized controlled trial with randomization at the local primary care physicians group

  15. Differences in Blood Pressure in Infants after General Anesthesia Compared to Awake Regional Anesthesia (GAS Study - A Prospective Randomized Trial)

    NARCIS (Netherlands)

    McCANN, M.E.; Withington, Davinia E.; Arnup, Sarah J.; Davidson, Andrew J.; DISMA, N.; FRAWLEY, G.; Morton, Neil S.; BELL, G.; Hunt, Rodney W.; Bellinger, David C; Polaner, D. M.; Leo-Macias, Alejandra; Absalom, Anthony R.; Von Ungern-Sternberg, Britta S.; Izzo, Francesca; Szmuk, Peter; Young, Vanessa; Soriano, S. G.; De Graaff, J. C.|info:eu-repo/dai/nl/249966271

    2017-01-01

    BACKGROUND: The General Anesthesia compared to Spinal anesthesia (GAS) study is a prospective randomized, controlled, multisite, trial designed to assess the influence of general anesthesia (GA) on neurodevelopment at 5 years of age. A secondary aim obtained from the blood pressure data of the GAS

  16. Speed Dependence of Crutch Force and Oxygen Uptake: Imlications for Design of Comparative Trials on Orthoses for People With Paraplegia

    NARCIS (Netherlands)

    IJzerman, Maarten Joost; Baardman, Gert; Hermens, Hermanus J.; Veltink, Petrus H.; Boom, H.B.K.; Zilvold, G.; Zilvold, Gerald

    1998-01-01

    Objective: To determine speed dependence of crutch force and oxygen uptake, and to discuss the implications of differences in self-selected walking speed between orthoses in a comparative trial. Design: Cross-sectional comparison. Setting: Treadmill experiments and gait laboratory experiments were

  17. Examination of Individual Differences in Outcomes from a Randomized Controlled Clinical Trial Comparing Formal and Informal Individual Auditory Training Programs

    Science.gov (United States)

    Smith, Sherri L.; Saunders, Gabrielle H.; Chisolm, Theresa H.; Frederick, Melissa; Bailey, Beth A.

    2016-01-01

    Purpose: The purpose of this study was to determine if patient characteristics or clinical variables could predict who benefits from individual auditory training. Method: A retrospective series of analyses were performed using a data set from a large, multisite, randomized controlled clinical trial that compared the treatment effects of at-home…

  18. A randomized trial comparing local intracervical and combined local and paracervical anesthesia in outpatient hysteroscopy.

    Science.gov (United States)

    Al-Sunaidi, Mohammed; Tulandi, Togas

    2007-01-01

    To compare the amount of pain during and after hysteroscopy using local intracervical and combined local and paracervical anesthesia. Prospective randomized trial (Canadian Task Force classification I). University teaching hospital. Eighty-four women who underwent outpatient hysteroscopy for evaluation of the uterine cavity at McGill University Health Center. Randomization to local intracervical or combined local and paracervical anesthesia. Amount of pain experienced during the procedure and at 10, 30, and 60 minutes after the procedure was measured using a visual analog scale ranging from zero to 10 (zero = no pain; 10 = excruciating pain). The mean age of the patients in the local anesthesia group was 36.1 +/- 0.7 years and in the combined local and paracervical anesthesia group was 35.2 +/- 0.7 years. Patients experienced significantly more pain during than after the procedure. The mean pain scores in the local anesthesia group were significantly higher than in the combined anesthesia group during the procedure (3.2 +/- 0.3 vs 2.1 +/- 0.2; p <.01; 95% CI 0-2), 10 minutes after the procedure (1.9 +/- 0.2 vs 1.5 +/- 0.3; p = .03; 95% CI 0-1), and 30 minutes after the procedure (1.7 +/- 0.2 vs 1.0 +/- 0.2; p = .02; 95% CI 0-1). However, there was no significant difference in pain scores at 60 minutes after the procedure between the local anesthesia and combined anesthesia groups (0.9 +/- 0.2 and 0.7 +/- 0.1, respectively). Outpatient hysteroscopy with local or combined local and paracervical anesthesia was well tolerated by patients. However, combined anesthesia was associated with less pain during and at 10 and 30 minutes after the procedure. Most patients considered the pain as mild.

  19. Comparing treatments for children with ADHD and word reading difficulties: A randomized clinical trial.

    Science.gov (United States)

    Tamm, Leanne; Denton, Carolyn A; Epstein, Jeffery N; Schatschneider, Christopher; Taylor, Heather; Arnold, L Eugene; Bukstein, Oscar; Anixt, Julia; Koshy, Anson; Newman, Nicholas C; Maltinsky, Jan; Brinson, Patricia; Loren, Richard E A; Prasad, Mary R; Ewing-Cobbs, Linda; Vaughn, Aaron

    2017-05-01

    This trial compared attention-deficit/hyperactivity disorder (ADHD) treatment alone, intensive reading intervention alone, and their combination for children with ADHD and word reading difficulties and disabilities (RD). Children (n = 216; predominantly African American males) in Grades 2-5 with ADHD and word reading/decoding deficits were randomized to ADHD treatment (medication + parent training), reading treatment (reading instruction), or combined ADHD + reading treatment. Outcomes were parent and teacher ADHD ratings and measures of word reading/decoding. Analyses utilized a mixed models covariate-adjusted gain score approach with posttest regressed onto pretest. Inattention and hyperactivity/impulsivity outcomes were significantly better in the ADHD (parent Hedges's g = .87/.75; teacher g = .67/.50) and combined (parent g = 1.06/.95; teacher g = .36/41) treatment groups than reading treatment alone; the ADHD and Combined groups did not differ significantly (parent g = .19/.20; teacher g = .31/.09). Word reading and decoding outcomes were significantly better in the reading (word reading g = .23; decoding g = .39) and combined (word reading g = .32; decoding g = .39) treatment groups than ADHD treatment alone; reading and combined groups did not differ (word reading g = .09; decoding g = .00). Significant group differences were maintained at the 3- to 5-month follow-up on all outcomes except word reading. Children with ADHD and RD benefit from specific treatment of each disorder. ADHD treatment is associated with more improvement in ADHD symptoms than RD treatment, and reading instruction is associated with better word reading and decoding outcomes than ADHD treatment. The additive value of combining treatments was not significant within disorder, but the combination allows treating both disorders simultaneously. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  20. A randomized trial comparing didactics, demonstration, and simulation for teaching teamwork to medical residents.

    Science.gov (United States)

    Semler, Matthew W; Keriwala, Raj D; Clune, Jennifer K; Rice, Todd W; Pugh, Meredith E; Wheeler, Arthur P; Miller, Alison N; Banerjee, Arna; Terhune, Kyla; Bastarache, Julie A

    2015-04-01

    Effective teamwork is fundamental to the management of medical emergencies, and yet the best method to teach teamwork skills to trainees remains unknown. In a cohort of incoming internal medicine interns, we tested the hypothesis that expert demonstration of teamwork principles and participation in high-fidelity simulation would each result in objectively assessed teamwork behavior superior to traditional didactics. This was a randomized, controlled, parallel-group trial comparing three teamwork teaching modalities for incoming internal medicine interns. Participants in a single-day orientation at the Vanderbilt University Center for Experiential Learning and Assessment were randomized 1:1:1 to didactic, demonstration-based, or simulation-based instruction and then evaluated in their management of a simulated crisis by five independent, blinded observers using the Teamwork Behavioral Rater score. Clinical performance was assessed using the American Heart Association Advanced Cardiac Life Support algorithm and a novel "Recognize, Respond, Reassess" score. Participants randomized to didactics (n = 18), demonstration (n = 17), and simulation (n = 17) were similar at baseline. The primary outcome of average overall Teamwork Behavioral Rater score for those who received demonstration-based training was similar to simulation participation (4.40 ± 1.15 vs. 4.10 ± 0.95, P = 0.917) and significantly higher than didactic instruction (4.40 ± 1.15 vs. 3.10 ± 0.51, P = 0.045). Clinical performance scores were similar between the three groups and correlated only weakly with teamwork behavior (coefficient of determination [Rs(2)] = 0.267, P teamwork training by expert demonstration resulted in similar teamwork behavior to participation in high-fidelity simulation and was more effective than traditional didactics. Clinical performance was largely independent of teamwork behavior and did not differ between training modalities.

  1. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose).

    Science.gov (United States)

    Morrison, Nick; Gibson, Kathleen; McEnroe, Scott; Goldman, Mitchel; King, Ted; Weiss, Robert; Cher, Daniel; Jones, Andrew

    2015-04-01

    Whereas thermal ablation of incompetent saphenous veins is highly effective, all heat-based ablation techniques require the use of perivenous subfascial tumescent anesthesia, involving multiple needle punctures along the course of the target vein. Preliminary evidence suggests that cyanoacrylate embolization (CAE) may be effective in the treatment of incompetent great saphenous veins (GSVs). We report herein early results of a randomized trial of CAE vs radiofrequency ablation (RFA) for the treatment of symptomatic incompetent GSVs. Two hundred twenty-two subjects with symptomatic GSV incompetence were randomly assigned to receive either CAE (n = 108) with the VenaSeal Sapheon Closure System (Sapheon, Inc, Morrisville, NC) or RFA (n = 114) with the ClosureFast system (Covidien, Mansfield, Mass). After discharge, subjects returned to the clinic on day 3 and again at months 1 and 3. The study's primary end point was closure of the target vein at month 3 as assessed by duplex ultrasound and adjudicated by an independent vascular ultrasound core laboratory. Statistical testing focused on showing noninferiority with a 10% delta conditionally followed by superiority testing. No adjunctive procedures were allowed until after the month 3 visit, and missing month 3 data were imputed by various methods. Secondary end points included patient-reported pain during vein treatment and extent of ecchymosis at day 3. Additional assessments included general and disease-specific quality of life surveys and adverse event rates. All subjects received the assigned intervention. By use of the predictive method for imputing missing data, 3-month closure rates were 99% for CAE and 96% for RFA. All primary end point analyses, which used various methods to account for the missing data rate (14%), showed evidence to support the study's noninferiority hypothesis (all P ecchymosis in the treated region was present after CAE compared with RFA (P ecchymosis. Copyright © 2015 Society for Vascular

  2. A randomized trial comparing 2 doses of polidocanol sclerotherapy for hydrocele or spermatocele.

    Science.gov (United States)

    Jahnson, Staffan; Sandblom, Dag; Holmäng, Sten

    2011-10-01

    Polidocanol sclerotherapy for hydrocele or spermatocele combines high efficiency with low morbidity, but the optimal dose is not known. We compared the efficacy and morbidity of 2 or 4 ml polidocanol sclerotherapy for hydrocele or spermatocele. From 1993 to 2005 a double-blind randomized clinical trial was conducted using 2 or 4 ml polidocanol (30 mg/ml) for sclerotherapy of hydrocele/spermatocele in 224 evaluable patients at 3 university hospitals. Fluid was evacuated and 2 or 4 ml polidocanol was administered by a nurse, with the amount injected concealed from others present. At 3-month followup morbidity was ascertained using a questionnaire completed by the patients. Fluid recurrence was determined clinically and generally re-treated. After the first treatment, cure was observed in 59% and 47% in the 4 and the 2 ml group, respectively (p = 0.04). More patients in the 4 ml group had complications (31% vs 18%, p = 0.04). Complications were mostly of low or moderate intensity and seldom required medication. After 1 to 4 treatments 200 of 224 patients (89%) were cured and another 10 (5%) had small amounts of residual fluid, with no difference between the groups. Of the patients with hydroceles/spermatoceles larger than 175 ml, 58% and 34% were cured after the first treatment in the 4 and 2 ml groups, respectively (p = 0.012), with no differences in complications between the groups. Polidocanol sclerotherapy was effective for the treatment of hydrocele or spermatocele in our patients, with 94% satisfactory results after 1 to 4 treatments. A dose of 4 ml was superior to 2 ml, particularly for larger hydroceles/spermatoceles. Copyright © 2011 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

  3. Pancreatitis, very early compared with normal start of enteral feeding (PYTHON trial: design and rationale of a randomised controlled multicenter trial

    Directory of Open Access Journals (Sweden)

    Schaapherder Alexander F

    2011-03-01

    Full Text Available Abstract Background In predicted severe acute pancreatitis, infections have a negative effect on clinical outcome. A start of enteral nutrition (EN within 24 hours of onset may reduce the number of infections as compared to the current practice of starting an oral diet and EN if necessary at 3-4 days after admission. Methods/Design The PYTHON trial is a randomised controlled, parallel-group, superiority multicenter trial. Patients with predicted severe acute pancreatitis (Imrie-score ≥ 3 or APACHE-II score ≥ 8 or CRP > 150 mg/L will be randomised to EN within 24 hours or an oral diet and EN if necessary, after 72 hours after hospital admission. During a 3-year period, 208 patients will be enrolled from 20 hospitals of the Dutch Pancreatitis Study Group. The primary endpoint is a composite of mortality or infections (bacteraemia, infected pancreatic or peripancreatic necrosis, pneumonia during hospital stay or within 6 months following randomisation. Secondary endpoints include other major morbidity (e.g. new onset organ failure, need for intervention, intolerance of enteral feeding and total costs from a societal perspective. Discussion The PYTHON trial is designed to show that a very early ( Trial Registration ISRCTN: ISRCTN18170985

  4. Impact of different nasal masks on CPAP therapy for obstructive sleep apnea: a randomized comparative trial.

    Science.gov (United States)

    Neuzeret, Pierre-Charles; Morin, Laurent

    2017-11-01

    Patient interface is important for the success of continuous positive airway pressure (CPAP), but few trials have examined the influence of mask choice on CPAP adherence. To compare the impact of different nasal masks on CPAP in patients with newly-diagnosed obstructive sleep apnea (OSA). OSA patients were randomized in a 2:3 ratio to receive CPAP via different first-line nasal masks: ResMed Mirage FX® (MFX) or control mask (Fisher & Paykel Zest ® , HC407 ® or Philips EasyLife ® ). Mask acceptance, CPAP compliance and Home Care Provider (HCP) interventions were compared between groups after 3 months of CPAP therapy using modified intent-to-treat (mITT; after exclusion of patients with mouth leaks during CPAP initiation) and on-treatment (OT; CPAP adherent) analyses. Of 285 randomized patients, 90 requiring a full-face mask were excluded, leaving 195 and 151 in the mITT and OT analyses, respectively. Mask acceptance rate was higher in the MFX versus control group (mITT: 79% vs 68%, P = 0.067; OT: 90% vs 76%, P = 0.022). CPAP compliance was higher (5.9 ± 1.8 vs 5.1 ± 1.6 h/night, P = 0.011) and nasal mask issue-related HCP visits lower (3% vs 17%, P = 0.006) in the MFX group. Nasal mask failures due to mask discomfort (5% vs 1%) or unintentional leakage (5% vs 0%) were higher in control vs MFX group. Mask acceptance was significantly associated with fewer mask leaks (P = 0.002) and higher pressure therapy (P = 0.042). This study highlights differences between nasal masks for CPAP delivery and shows that initial mask selection can influence adherence and healthcare utilization during CPAP. © 2016 ResMed Germany Inc. The Clinical Respiratory Journal published by John Wiley & Sons Ltd.

  5. Early rehabilitation after lumbar disc surgery is not effective or cost-effective compared to no referral: a randomised trial and economic evaluation

    Directory of Open Access Journals (Sweden)

    Teddy Oosterhuis

    2017-07-01

    Trial registration: Netherlands Trial Register NTR3156. [Oosterhuis T, Ostelo RW, van Dongen JM, Peul WC, de Boer MR, Bosmans JE, Vleggeert-Lankamp CL, Arts MP, van Tulder MW (2017 Early rehabilitation after lumbar disc surgery is not effective or cost-effective compared to no referral: a randomised trial and economic evaluation. Journal of Physiotherapy 63: 144–153

  6. Nurse Family Partnership: Comparing Costs per Family in Randomized Trials Versus Scale-Up.

    Science.gov (United States)

    Miller, Ted R; Hendrie, Delia

    2015-12-01

    The literature that addresses cost differences between randomized trials and full-scale replications is quite sparse. This paper examines how costs differed among three randomized trials and six statewide scale-ups of nurse family partnership (NFP) intensive home visitation to low income first-time mothers. A literature review provided data on pertinent trials. At our request, six well-established programs reported their total expenditures. We adjusted the costs to national prices based on mean hourly wages for registered nurses and then inflated them to 2010 dollars. A centralized data system provided utilization. Replications had fewer home visits per family than trials (25 vs. 31, p = .05), lower costs per client ($8860 vs. $12,398, p = .01), and lower costs per visit ($354 vs. $400, p = .30). Sample size limited the significance of these differences. In this type of labor intensive program, costs probably were lower in scale-up than in randomized trials. Key cost drivers were attrition and the stable caseload size possible in an ongoing program. Our estimates reveal a wide variation in cost per visit across six state programs, which suggests that those planning replications should not expect a simple rule to guide cost estimations for scale-ups. Nevertheless, NFP replications probably achieved some economies of scale.

  7. Low-cost transobturator vaginal tape inside-out procedure for the treatment of female stress urinary incontinence using ordinary polypropylene mesh.

    Science.gov (United States)

    ElSheemy, Mohammed S; Elsergany, Ragheb; ElShenoufy, Ahmed

    2015-04-01

    The aim of this study is to describe the use of ordinary polypropylene mesh and our modified helical passers through a transobturator vaginal tape inside-out technique (TVT-O) as a low-cost alternative to available commercial kits in the treatment of stress urinary incontinence (SUI) with evaluation of its long-term safety and efficacy. This is important in developing countries due to limited health care resources. Tailored (11 × 1.5 cm) polypropylene tape was inserted in 59 women from June 2006 to June 2009 at the Urology Department, Cairo University Hospitals as an open prospective study. SUI was diagnosed by positive cough stress test (CST) and abdominal leak point pressure (ALPP). Patients with post-void residual urine (PVRU) > 100 ml, bladder capacity polypropylene suture (1 %) and felt subcutaneous polypropylene sutures (3 %). We had no cases of erosions or de novo urgency. SUIQQ indices improved significantly, while urodynamic parameters showed no significant difference postoperatively. Of the patients, 54 (91 %) were cured and 3 (5 %) improved, while failure was detected in 2 (3 %) patients. Our technique is safe with excellent 5-year results. It should be considered as a low-cost alternative to available commercial kits in the treatment of SUI mainly for public health systems with few financial resources.

  8. Comparing ICD9-encoded diagnoses and NLP-processed discharge summaries for clinical trials pre-screening: a case study.

    Science.gov (United States)

    Li, Li; Chase, Herbert S; Patel, Chintan O; Friedman, Carol; Weng, Chunhua

    2008-11-06

    The prevalence of electronic medical record (EMR) systems has made mass-screening for clinical trials viable through secondary uses of clinical data, which often exist in both structured and free text formats. The tradeoffs of using information in either data format for clinical trials screening are understudied. This paper compares the results of clinical trial eligibility queries over ICD9-encoded diagnoses and NLP-processed textual discharge summaries. The strengths and weaknesses of both data sources are summarized along the following dimensions: information completeness, expressiveness, code granularity, and accuracy of temporal information. We conclude that NLP-processed patient reports supplement important information for eligibility screening and should be used in combination with structured data.

  9. Comparing Haemophilus influenzae type b conjugate vaccine schedules: a systematic review and meta-analysis of vaccine trials.

    Science.gov (United States)

    Low, Nicola; Redmond, Shelagh M; Rutjes, Anne W S; Martínez-González, Nahara A; Egger, Matthias; di Nisio, Marcello; Scott, Pippa

    2013-11-01

    The optimal schedule and the need for a booster dose are unclear for Haemophilus influenzae type b (Hib) conjugate vaccines. We systematically reviewed relative effects of Hib vaccine schedules. We searched 21 databases to May 2010 or June 2012 and selected randomized controlled trials or quasi-randomized controlled trials that compared different Hib schedules (3 primary doses with no booster dose [3p+0], 3p+1 and 2p+1) or different intervals in primary schedules and between primary and booster schedules. Outcomes were clinical efficacy, nasopharyngeal carriage and immunological response. Results were combined in random-effects meta-analysis. Twenty trials from 15 countries were included; 16 used vaccines conjugated to tetanus toxoid (polyribosylribitol phosphate conjugated to tetanus toxoid). No trials assessed clinical or carriage outcomes. Twenty trials examined immunological outcomes and found few relevant differences. Comparing polyribosylribitol phosphate conjugated to tetanus toxoid 3p+0 with 2p+0, there was no difference in seropositivity at the 1.0 μg/mL threshold by 6 months after the last primary dose (combined risk difference -0.02; 95% confidence interval: -0.10, 0.06). Only small differences were seen between schedules starting at different ages, with different intervals between primary doses, or with different intervals between primary and booster doses. Individuals receiving a booster were more likely to be seropositive than those at the same age who did not. There is no clear evidence from trials that any 2p+1, 3p+0 or 3p+1 schedule of Hib conjugate vaccine is likely to provide better protection against Hib disease than other schedules. Until more data become available, scheduling is likely to be determined by epidemiological and programmatic considerations in individual settings.

  10. Protocol for the OUTREACH trial: a randomised trial comparing delivery of cancer systemic therapy in three different settings - patient's home, GP surgery and hospital day unit

    Directory of Open Access Journals (Sweden)

    McCrone Paul

    2011-10-01

    Full Text Available Abstract Background The national Cancer Reform Strategy recommends delivering care closer to home whenever possible. Cancer drug treatment has traditionally been administered to patients in specialist hospital-based facilities. Technological developments mean that nowadays, most treatment can be delivered in the out-patient setting. Increasing demand, care quality improvements and patient choice have stimulated interest in delivering some treatment to patients in the community, however, formal evaluation of delivering cancer treatment in different community settings is lacking. This randomised trial compares delivery of cancer treatment in the hospital with delivery in two different community settings: the patient's home and general practice (GP surgeries. Methods/design Patients due to receive a minimum 12 week course of standard intravenous cancer treatment at two hospitals in the Anglia Cancer Network are randomised on a 1:1:1 basis to receive treatment in the hospital day unit (control arm, or their own home, or their choice of one of three neighbouring GP surgeries. Overall patient care, treatment prescribing and clinical review is undertaken according to standard local practice. All treatment is dispensed by the local hospital pharmacy and treatment is delivered by the hospital chemotherapy nurses. At four time points during the 12 week study period, information is collected from patients, nursing staff, primary and secondary care teams to address the primary end point, patient-perceived benefits (using the emotional function domain of the EORTC QLQC30 patient questionnaire, as well as secondary end points: patient satisfaction, safety and health economics. Discussion The Outreach trial is the first randomised controlled trial conducted which compares delivery of out-patient based intravenous cancer treatment in two different community settings with standard hospital based treatment. Results of this study may better inform all key

  11. A randomised comparative trial of infusional ECisF versus conventional FEC as adjuvant chemotherapy in early breast cancer: the TRAFIC trial.

    Science.gov (United States)

    Sirohi, B; A'Hern, R; Coombes, G; Bliss, J M; Hickish, T; Perren, T; Crawford, M; O'Brien, M; Iveson, T; Ebbs, S; Skene, A; Laing, R; Smith, I E

    2010-08-01

    The epirubicin with cisplatin and infusional 5-fluorouracil (5-FU) (ECisF) regimen was found to be highly active in the treatment of metastatic breast cancer and as neoadjuvant therapy. The UK TRAFIC (trial of adjuvant 5-FU infusional chemotherapy) trial (CRUK/95/007) compared this schedule with 5-FU, epirubicin and cyclophosphamide (FEC60) as adjuvant therapy in patients with early breast cancer. In this multicentre, open-label, phase III randomised controlled trial, 349 women were randomly assigned to receive i.v. ECisF [epirubicin 60 mg/m(2), day 1, cisplatin 60 mg/m(2), day 1 and 5-FU 200 mg/m(2) by daily 24-h infusion (n = 172)] or FEC [5-FU 600 mg/m(2), day 1, epirubicin 60 mg/m(2), day 1 and cyclophosphamide 600 mg/m(2), day 1 (n = 177)]. Both treatments were delivered every 3 weeks for six cycles. The primary end point was relapse-free interval (RFI). TRAFIC is registered as an International Standard Randomised Controlled Trial (ISRCTN 83324925). All randomised patients were included in the intent-to-treat population. With a median follow-up of 112 months, there was no significant difference in RFI between the treatment groups [hazard ratio 0.84 (95% confidence interval 0.60-1.19); P = 0.33]. Toxic effects were more frequent in patients allocated to ECisF. While limited by size, TRAFIC has long follow-up. No evidence of a clinically worthwhile benefit for the infusional treatment compared with standard treatment was observed which would justify further investigation or widespread use.

  12. Comparative effectiveness of childhood obesity interventions in pediatric primary care: a cluster-randomized clinical trial.

    Science.gov (United States)

    Taveras, Elsie M; Marshall, Richard; Kleinman, Ken P; Gillman, Matthew W; Hacker, Karen; Horan, Christine M; Smith, Renata L; Price, Sarah; Sharifi, Mona; Rifas-Shiman, Sheryl L; Simon, Steven R

    2015-06-01

    Evidence of effective treatment of childhood obesity in primary care settings is limited. To examine the extent to which computerized clinical decision support (CDS) delivered to pediatric clinicians at the point of care of obese children, with or without individualized family coaching, improved body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) and quality of care. We conducted a cluster-randomized, 3-arm clinical trial. We enrolled 549 children aged 6 to 12 years with a BMI at the 95% percentile or higher from 14 primary care practices in Massachusetts from October 1, 2011, through June 30, 2012. Patients were followed up for 1 year (last follow-up, August 30, 2013). In intent-to-treat analyses, we used linear mixed-effects models to account for clustering by practice and within each person. In 5 practices randomized to CDS, pediatric clinicians received decision support on obesity management, and patients and their families received an intervention for self-guided behavior change. In 5 practices randomized to CDS + coaching, decision support was augmented by individualized family coaching. The remaining 4 practices were randomized to usual care. Smaller age-associated change in BMI and the Healthcare Effectiveness Data and Information Set (HEDIS) performance measures for obesity during the 1-year follow-up. At baseline, mean (SD) patient age and BMI were 9.8 (1.9) years and 25.8 (4.3), respectively. At 1 year, we obtained BMI from 518 children (94.4%) and HEDIS measures from 491 visits (89.4%). The 3 randomization arms had different effects on BMI over time (P = .04). Compared with the usual care arm, BMI increased less in children in the CDS arm during 1 year (-0.51 [95% CI, -0.91 to -0.11]). The CDS + coaching arm had a smaller magnitude of effect (-0.34 [95% CI, -0.75 to 0.07]). We found substantially greater achievement of childhood obesity HEDIS measures in the CDS arm (adjusted odds ratio, 2.28 [95% CI, 1

  13. Comparative prospective randomized trial: laparoscopic versus open common bile duct exploration

    Directory of Open Access Journals (Sweden)

    Vladimir Grubnik

    2011-06-01

    Full Text Available Introduction: Single-stage laparoscopic procedures for common bile duct (CBD stones are an alternative treatmentoption to two-stage endo-laparoscopic treatment and to open choledocholithotomy. Several reports have demonstratedthe feasibility, safety, efficiency and cost-effectiveness of laparoscopic techniques.Aim: To analyse the safety and benefits of laparoscopic compared to open common bile duct (CBD exploration.Material and methods: The prospective randomized trial included a total of 256 patients with CBD stones operated from2005 to 2009 in a single centre. The male/female ratio was 82/174, with a median age 62.3 ±5.8 years (range 27 to 87years. There were two groups of patients. Group I: laparoscopic CBD exploration (138 patients. Group II: open CBD exploration(118 patients. Patient comorbidity was assessed by means of the American Society of Anesthesiologists (ASA classification;ASA II – 109 patients, ASA III – 59 patients. Bile duct stones were visualized preoperatively by means of US examinationin 129 patients, by means of ERCP in 26 patients, and by magnetic resonance cholangiopancreatography (MRCPin 72 patients. Preoperative evaluation was done through medical history, biochemical tests and ultrasonography.Results: The mean duration of laparoscopic procedures was 82 min (range 40-160 min. The mean duration of openprocedures was 90 min (range 60-150 min. Mean blood loss was much lower in the laparoscopic group than in theopen group (20 ±2 v.s 285 ±27, p < 0.01. Postoperative complications were observed in 7 patients of the laparoscopicgroup and in 15 patients in the open group (p < 0.01. Laparoscopic common bile duct exploration was performedthrough a trans-cystic approach in 76 patients and via choledochotomy in 62 patients. The transcystic approach wassuccessful in 76 patients (74.5%. External drainage was used in 25 (32.8% patients with the transcystic approach.Conclusions: Laparoscopic CBD exploration can be performed with

  14. Surgical staples compared with subcuticular suture for skin closure after cesarean delivery: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Sahar Assadi

    2016-03-01

    Full Text Available Background: Cesarean delivery is the most common surgical procedure and this prevalence is on the rise. Given these trends, cesarean wound complications, such as disruption or infection, remain an important cause of post-cesarean morbidity. Methods: We conducted a single-center randomized controlled trial that included women with viable pregnancies (≥24 weeks undergoing cesarean delivery at Motahary University Hospital, Urmia, Iran from April to November 2014. All cesarean types were included: scheduled or unscheduled and primary or repeat cesareans. Women were excluded for the following reasons: inability to obtain informed consent, immune compromising disease (e.g. AIDS, chronic steroid use, diabetic mellitus and BMI≥30. Of 266 women, 133 were randomized to staples and 133 women to suture group. Results: The mean±SD age of the staples group was 27.6±5.4 years and mean±SD age of suture was 28.7±5.9 years. Multiparity is the most frequent in both groups that by using Chi-square test, no significant differences were observed between the two groups (P=0.393. The most frequent indication for cesarean section in both groups was history of cesarean section in staple 40 cases (30.1% and suture 32 cases (24.1%. The survey was conducted using the Chi-square test was not significant (P=0.381. Pain at 6 weeks postoperatively was significantly less in the staple group (P=0.001. Operative time was longer with suture closure (4.68±0.67 versus 1.03±0.07 minute, P<0.001. The Vancouver scale score was significantly less in suture closure (6.6±0.8 versus 7.5±0.9, P=0.001. Wound disruption was significantly less in suture closure (3.8% versus 11.3%, P=0.017. Conclusion: The staple group had low pain and operation time but had a significant wound disruption and scar. The patients who have suffered a significant wound disruption were affected by age (P=0.022 and BMI (P=0.001 at compared those who were not affected by factors such as age or high BMI as

  15. Randomized clinical trial comparing control of maxillary anchorage with 2 retraction techniques.

    Science.gov (United States)

    Xu, Tian-Min; Zhang, Xiaoyun; Oh, Hee Soo; Boyd, Robert L; Korn, Edward L; Baumrind, Sheldon

    2010-11-01

    The objective of this pilot randomized clinical trial was to investigate the relative effectiveness of anchorage conservation of en-masse and 2-step retraction techniques during maximum anchorage treatment in patients with Angle Class I and Class II malocclusions. Sixty-four growing subjects (25 boys, 39 girls; 10.2-15.9 years old) who required maximum anchorage were randomized to 2 treatment techniques: en-masse retraction (n = 32) and 2-step retraction (n = 32); the groups were stratified by sex and starting age. Each patient was treated by a full-time clinic instructor experienced in the use of both retraction techniques at the orthodontic clinic of Peking University School of Stomatology in China. All patients used headgear, and most had transpalatal appliances. Lateral cephalograms taken before treatment and at the end of treatment were used to evaluate treatment-associated changes. Differences in maxillary molar mesial displacement and maxillary incisor retraction were measured with the before and after treatment tracings superimposed on the anatomic best fit of the palatal structures. Differences in mesial displacement of the maxillary first molar were compared between the 2 treatment techniques, between sexes, and between different starting-age groups. Average mesial displacement of the maxillary first molar was slightly less in the en-masse group than in the 2-step group (mean, -0.36 mm; 95% CI, -1.42 to 0.71 mm). The average mesial displacement of the maxillary first molar for both treatment groups pooled (n = 63, because 1 patient was lost to follow-up) was 4.3 ± 2.1 mm (mean ± standard deviation). Boys had significantly more mesial displacement than girls (mean difference, 1.3 mm; P <0.03). Younger adolescents had significantly more mesial displacement than older adolescents (mean difference, 1.3 mm; P <0.02). Average mesial displacement of the maxillary first molar with 2-step retraction was slightly greater than that for en-masse retraction, but the

  16. Explaining Feast or Famine in Randomized Field Trials: Medical Science and Criminology Compared.

    Science.gov (United States)

    Shepherd, Jonathan P.

    2003-01-01

    Discusses the contrast between the frequency of randomized clinical trials in the health sciences and the relative famine of such studies in criminology. Attributes this difference to the contexts in which research is done and the difference in the status of situational research in the two disciplines. (SLD)

  17. COLOR II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer

    DEFF Research Database (Denmark)

    Buunen, M; Bonjer, H J; Hop, W C J

    2009-01-01

    clinical trial. Currently 27 hospitals from Europe, South Korea and Canada are including patients. The primary endpoint is loco-regional recurrence rate three years post-operatively. Secondary endpoints cover quality of life, overall and disease free survival, post-operative morbidity and health economy...

  18. The Tilburg double blind randomised controlled trial comparing inguinal hernia repair according to Lichtenstein and the transinguinal preperitoneal technique

    Directory of Open Access Journals (Sweden)

    Gerritsen Pieter G

    2009-09-01

    Full Text Available Abstract Background Anterior open treatment of the inguinal hernia with a tension free mesh has reduced the incidence of recurrence and direct postoperative pain. The Lichtenstein procedure rules nowadays as reference technique for hernia treatment. Not recurrences but chronic pain is the main postoperative complication in inguinal hernia repair after Lichtenstein's technique. Preliminary experiences with a soft mesh placed in the preperitoneal space showed good results and less chronic pain. Methods The TULIP is a double-blind randomised controlled trial in which 300 patients will be randomly allocated to anterior inguinal hernia repair according to Lichtenstein or the transinguinal preperitoneal technique with soft mesh. All unilateral primary inguinal hernia patients eligible for operation who meet inclusion criteria will be invited to participate in this trial. The primary endpoint will be direct postoperative- and chronic pain. Secondary endpoints are operation time, postoperative complications, hospital stay, costs, return to daily activities (e.g. work and recurrence. Both groups will be evaluated. Success rate of hernia repair and complications will be measured as safeguard for quality. To demonstrate that inguinal hernia repair according to the transinguinal preperitoneal (TIPP technique reduces postoperative pain to Discussion The TULIP trial is aimed to show a reduction in postoperative chronic pain after anterior hernia repair according to the transinguinal preperitoneal (TIPP technique, compared to Lichtenstein. In our hypothesis the TIPP technique reduces chronic pain compared to Lichtenstein. Trial registration ISRCTN 93798494

  19. Systematic review and meta-analysis of published, randomized, controlled trials comparing suture anastomosis to stapled anastomosis for ileostomy closure.

    Science.gov (United States)

    Sajid, M S; Craciunas, L; Baig, M K; Sains, P

    2013-12-01

    The objective of this article is to systematically analyze the randomized, controlled trials comparing the effectiveness of suture anastomosis (SUA) versus stapled anastomosis (STA) in patients undergoing ileostomy closure. Randomized, controlled trials comparing the effectiveness of SUA versus STA in patients undergoing ileostomy closure were analyzed using RevMan(®), and combined outcomes were expressed as odds risk ratio (OR) and standardized mean difference (SMD). Four randomized, controlled trials that recruited 645 patients were retrieved from electronic databases. There were 327 patients in the STA group and 318 patients in the SUA group. There was significant heterogeneity among included trials. Operative time (SMD -1.02; 95 % CI -1.89, -0.15; z = 2.29; p infection, reoperation and readmission were similar following STA and SUA in patients undergoing ileostomy closure. Length of hospital stay was also similar between STA and SUA groups. In ileostomy closure, STA was associated with shorter operative time and lower risk of postoperative small bowel obstruction. However, STA and SUA were similar in terms of anastomotic leak, surgical site infection, readmission, reoperations and length of hospital stay.

  20. Comparative study of outcome measures and analysis methods for traumatic brain injury trials.

    Science.gov (United States)

    Alali, Aziz S; Vavrek, Darcy; Barber, Jason; Dikmen, Sureyya; Nathens, Avery B; Temkin, Nancy R

    2015-04-15

    Batteries of functional and cognitive measures have been proposed as alternatives to the Extended Glasgow Outcome Scale (GOSE) as the primary outcome for traumatic brain injury (TBI) trials. We evaluated several approaches to analyzing GOSE and a battery of four functional and cognitive measures. Using data from a randomized trial, we created a "super" dataset of 16,550 subjects from patients with complete data (n=331) and then simulated multiple treatment effects across multiple outcome measures. Patients were sampled with replacement (bootstrapping) to generate 10,000 samples for each treatment effect (n=400 patients/group). The percentage of samples where the null hypothesis was rejected estimates the power. All analytic techniques had appropriate rates of type I error (≤5%). Accounting for baseline prognosis either by using sliding dichotomy for GOSE or using regression-based methods substantially increased the power over the corresponding analysis without accounting for prognosis. Analyzing GOSE using multivariate proportional odds regression or analyzing the four-outcome battery with regression-based adjustments had the highest power, assuming equal treatment effect across all components. Analyzing GOSE using a fixed dichotomy provided the lowest power for both unadjusted and regression-adjusted analyses. We assumed an equal treatment effect for all measures. This may not be true in an actual clinical trial. Accounting for baseline prognosis is critical to attaining high power in Phase III TBI trials. The choice of primary outcome for future trials should be guided by power, the domain of brain function that an intervention is likely to impact, and the feasibility of collecting outcome data.

  1. A randomized controlled trial comparing split and subunit influenza vaccines in adults in Colombia

    Directory of Open Access Journals (Sweden)

    A. Morales

    2003-06-01

    Full Text Available In a two-center, comparative trial, 344 adults were randomly assigned to receive a single dose of inactivated split-virion (Imovax Gripeâ or sub-unit (Agrippal S1â influenza vaccine (1999-2000 formulations. For analysis, study groups were subdivided into adult (18-60 years old and elderly (over 60 years subjects. Blood was drawn immediately before and one month after vaccination, safety was evaluated using a blind-observer design based on reporting of solicited and unsolicited adverse events. Both vaccines were very well tolerated, had similar reactogenicity profiles, and elicited fewer reports of reactions in elderly individuals. Post-vaccination Imovax Gripeâ induced seroprotective antibody titers against the three vaccine strains in 94-99% of adults and 88-97% of elderly subjects, compared with 88-100% and 88-98%, respectively, of those given Agrippal S1â. In conclusion, the split-virion and sub-unit influenza vaccines had similar safety and reactogenicity profiles, and elicited satisfactory immunity in adult and elderly subjects. However, higher post-vaccination geometric mean titer (GMT values in response to the B strain were seen with the split vaccine Imovax Gripeâ, giving it a better overall immunogenicity.En un ensayo comparativo realizado en dos centros, se asignaron de manera aleatoria 344 adultos para recibir una dosis de vacuna contra la gripe de virus fraccionado inactivado (Imovax Gripeâ o de vacuna de subunidades (Agrippal S1â (formulaciones 1999-2000. Para el análisis, los grupos estudiados fueron subdivididos en adultos (18-60 años y ancianos (más de 60 años. La sangre fue extraída justo antes y un mes después de la vacunación. La inocuidad fue evaluada utilizando un informe sobre reacciones adversas, usando un diseño de observador a ciegas. Ambas vacunas fueron muy bien toleradas, con perfiles de reactogenicidad similares y desarrollaron escasas reacciones adversas en los individuos ancianos. La vacunación con

  2. Is a comparative clinical trial for breast cancer tumor markers to monitor disease recurrence warranted? A value of information analysis.

    Science.gov (United States)

    Thariani, Rahber; Henry, Norah Lynn; Ramsey, Scott D; Blough, David K; Barlow, Bill; Gralow, Julie R; Veenstra, David L

    2013-05-01

    Breast cancer tumor markers are used by some clinicians to screen for disease recurrence risk. Since there is limited evidence of benefit, additional research may be warranted. To assess the potential value of a randomized clinical trial of breast tumor marker testing in routine follow-up of high-risk, stage II-III breast cancer survivors. We developed a decision-analytic model of tumor marker testing plus standard surveillance every 3-6 months for 5 years. The expected value of sample information was calculated using probabilistic simulations and was a function of: the probability of selecting the optimal monitoring strategy with current versus future information; the impact of choosing the nonoptimal strategy; and the size of the population affected. The value of information for a randomized clinical trial involving 9000 women was US$214 million compared with a cost of US$30-60 million to conduct such a trial. The probability of making an alternate, nonoptimal decision and choosing testing versus no testing was 32% with current versus future information from the trial. The impact of a nonoptimal decision was US$2150 and size of population impacted over 10 years was 308,000. The value of improved information on overall survival was US$105 million, quality of life US$37 million and test performance US$71 million. Conducting a randomized clinical trial of breast cancer tumor markers appears to offer a good societal return on investment. Retrospective analyses to assess test performance and evaluation of patient quality of life using tumor markers may also offer valuable areas of research. However, alternative investments may offer even better returns in investments and, as such, the trial concept deserves further study as part of an overall research-portfolio evaluation.

  3. Prospective Randomized Trial Comparing Transperitoneal Versus Extraperitoneal Laparoscopic Aortic Lymphadenectomy for Surgical Staging of Endometrial and Ovarian Cancer: The STELLA Trial.

    Science.gov (United States)

    Díaz-Feijoo, Berta; Correa-Paris, Alejandro; Pérez-Benavente, Assumpció; Franco-Camps, Silvia; Sánchez-Iglesias, José Luis; Cabrera, Silvia; de la Torre, Javier; Centeno, Cristina; Puig, Oriol Puig; Gil-Ibañez, Blanca; Colas, Eva; Magrina, Javier; Gil-Moreno, Antonio

    2016-09-01

    There is an ongoing debate on which approach, transperitoneal or extraperitoneal, is superior for the performance of laparoscopic aortic lymphadenectomy (LPA-LND) for the surgical staging of gynecologic cancer. A prospective randomized trial (STELLA trial) was designed to compare the perioperative outcomes and node retrieval of extraperitoneal versus transperitoneal aortic lymphadenectomy by laparoscopy or robot-assisted laparoscopy. Patients with endometrial or ovarian carcinoma requiring aortic lymphadenectomy for surgical staging were randomized to an extraperitoneal or transperitoneal approach by laparoscopy or robot-assisted laparoscopy between June 2012 and July 2014. A total of 60 patients were entered into the study, 48 with endometrial cancer (80 %) and 12 with ovarian cancer (20 %). Thirty-one patients (51.6 %) were randomly assigned to the extraperitoneal group and 29 to the transperitoneal group (48.3 %). The means LPA-LND operating time was 90 min in both group (p = 0.343). The mean (range) blood loss was 105 (10-400) mL for extraperitoneal versus 100 (5-1000) mL for transperitoneal group (p = 0.541). There were no differences in the number of collected lymph nodes between the two groups [median (range) for extraperitoneal 12 (4-41) vs. 13 (4-29) for transperitoneal (p = 0.719)]. The extraperitoneal and transperitoneal approaches for laparoscopic and robotic aortic lymphadenectomy provide similar perioperative outcomes and nodal yields. The STELLA trial is registered at the US National Institutes of Health (ClinicalTrials.gov) #NCT01810874.

  4. Informed consent from cognitively impaired persons participating in research trials: comparative law observations

    Directory of Open Access Journals (Sweden)

    Carlo Petrini

    2011-12-01

    Full Text Available This article addresses the ethical requirements to be considered when conducting clinical trials involving human subjects whose mental condition limits their ability to understand the information and to express fully autonomous and informed consent. It does not address other categories of vulnerable persons, such as children, or advanced directives concerning end-of-life care. There are many ethical issues entailed in clinical trials involving subjects with mental disabilities: how to obtain informed consent, balancing risks and benefits, balancing individual benefits with collective scientific and social interests, legal representation and many more. This article focuses on the issues surrounding the concept of minimal risk and the relationship between informed consent and risk. These issues are addressed with particular emphasis on the regulations adopted by the European Union and the federal government of the United States of America. The conclusion proposes a list of working criteria.

  5. GALA: an international multicentre randomised trial comparing general anaesthesia versus local anaesthesia for carotid surgery

    OpenAIRE

    Dellagrammaticas Demosthenes; Torgerson David; Gough Moira; Banning Adrian P; Rothwell Peter M; Lewis Steff C; Colam Bridget; Horrocks Michael; Bodenham Andrew; Gough Michael J; Leigh-Brown Anne; Liapis Christos; Warlow Charles

    2008-01-01

    Abstract Background Patients who have severe narrowing at or near the origin of the internal carotid artery as a result of atherosclerosis have a high risk of ischaemic stroke ipsilateral to the arterial lesion. Previous trials have shown that carotid endarterectomy improves long-term outcomes, particularly when performed soon after a prior transient ischaemic attack or mild ischaemic stroke. However, complications may occur during or soon after surgery, the most serious of which is stroke, w...

  6. A Comparative Effectiveness Trial of Three Walking Self-monitoring Strategies

    OpenAIRE

    Richardson, Caroline R.; Goodrich, David E.; Larkin, Angela R.; Ronis, David L.; Holleman, Robert G.; Damschroder, Laura J.; Lowery, Julie C.

    2016-01-01

    ABSTRACT Walking programs improve health outcomes in adults at risk for cardiovascular disease (CVD), and self-monitoring strategies can improve adherence to such programs. The objective of this study was to determine whether a 6-month Internet-based walking program using Web-enhanced pedometers results in more weight loss than walking programs based on time or simple pedometer step count goals in adults with or at risk for CVD. This was a multisite, randomized controlled trial of 255 male ve...

  7. Reducing Trunk Compensation in Stroke Survivors: A Randomized Crossover Trial Comparing Visual and Force Feedback Modalities.

    Science.gov (United States)

    Valdés, Bulmaro Adolfo; Schneider, Andrea Nicole; Van der Loos, H F Machiel

    2017-10-01

    To investigate whether the compensatory trunk movements of stroke survivors observed during reaching tasks can be decreased by force and visual feedback, and to examine whether one of these feedback modalities is more efficacious than the other in reducing this compensatory tendency. Randomized crossover trial. University research laboratory. Community-dwelling older adults (N=15; 5 women; mean age, 64±11y) with hemiplegia from nontraumatic hemorrhagic or ischemic stroke (>3mo poststroke), recruited from stroke recovery groups, the research group's website, and the community. In a single session, participants received augmented feedback about their trunk compensation during a bimanual reaching task. Visual feedback (60 trials) was delivered through a computer monitor, and force feedback (60 trials) was delivered through 2 robotic devices. Primary outcome measure included change in anterior trunk displacement measured by motion tracking camera. Secondary outcomes included trunk rotation, index of curvature (measure of straightness of hands' path toward target), root mean square error of hands' movement (differences between hand position on every iteration of the program), completion time for each trial, and posttest questionnaire to evaluate users' experience and system's usability. Both visual (-45.6% [45.8 SD] change from baseline, P=.004) and force (-41.1% [46.1 SD], P=.004) feedback were effective in reducing trunk compensation. Scores on secondary outcome measures did not improve with either feedback modality. Neither feedback condition was superior. Visual and force feedback show promise as 2 modalities that could be used to decrease trunk compensation in stroke survivors during reaching tasks. It remains to be established which one of these 2 feedback modalities is more efficacious than the other as a cue to reduce compensatory trunk movement. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  8. How Does Your PICCOMPARE? A Pilot Randomized Controlled Trial Comparing Various PICC Materials in Pediatrics.

    Science.gov (United States)

    Kleidon, Tricia; Ullman, Amanda J; Zhang, Li; Mihala, Gabor; Chaseling, Brett; Schoutrop, Jason; Rickard, Claire M

    2018-02-08

    Despite the popularity of peripherally inserted central catheters (PICCs), recent literature highlights their potential injurious complications. Innovative PICC materials have been developed to prevent thrombosis and infection formation (Endexo®) and antireflux valves to prevent occlusion (pressure-activated safety valve®). No large randomized controlled trial has assessed these technologies. Our primary aim was to evaluate the feasibility of a large randomized controlled efficacy trial of PICC materials and design to reduce PICC complication in pediatrics. A randomized controlled feasibility trial was undertaken at the Lady Cilento Children's Hospital in South Brisbane, Australia, between March 2016 and November 2016. Consecutive recruitment of 150 pediatric participants were randomly assigned to receive either (1) polyurethane PICC with a clamp or (2) BioFlo® PICC (AngioDynamics Inc, Queensbury, NY). Primary outcomes were trial feasibility, including PICC failure (thrombosis, occlusion, infection, breakage, or dislodgement). Secondary outcomes were PICC complications during use. Protocol feasibility was established, including staff and patient acceptability, timely recruitment, no missing primary outcome data, and 0% attrition. PICC failure was 22% (16 of 74, standard care) and 11% (8 of 72, BioFlo®) corresponding to 12.6 and 7.3 failures per 1000 hours (risk ratio 0.58; 95% confidence interval, 0.21-1.43; P = .172). PICC failures were primarily due to thrombosis (standard care 7% versus BioFlo® 3%) and complete occlusion (standard care 7% versus BioFlo® 1%). No blood stream infections occurred. Significantly fewer patients with BioFlo® had PICC complications during use (15% vs 34%; P = .009). BioFlo® PICCs appear potentially safer for pediatrics than traditional standard care PICCs with a clamp. Further research is required to definitively identify clinical, cost-effective methods to prevent PICC failure and improve reliability. © 2018 Society of

  9. Comparative double blind clinical trial of phenytoin and sodium valproate as anticonvulsant prophylaxis after craniotomy: efficacy, tolerability, and cognitive effects

    OpenAIRE

    Beenen, L.F.M.; Lindeboom, J.; Kasteleijn-Nolst Trenite, D.G.; Heimans, J.J.; Snoek, F.J.; Touw, D.J.; Ader, H.J.; Alphen, van, H.A.M.

    1999-01-01

    OBJECTIVE—To determine the efficacy, tolerability, and impact on quality of life and cognitive functioning of anticonvulsant prophylaxis with phenytoin or sodium valproate in patients after craniotomy.
METHODS—A prospective, stratified, randomised, double blind single centre clinical trial was performed, comparing two groups of 50patients each, who underwent craniotomy for different pathological conditions and who were treated for 1 year after surgery with either 300 mg p...

  10. How well do randomized trials inform decision making: systematic review using comparative effectiveness research measures on acupuncture for back pain.

    Science.gov (United States)

    Witt, Claudia M; Manheimer, Eric; Hammerschlag, Richard; Lüdtke, Rainer; Lao, Lixing; Tunis, Sean R; Berman, Brian M

    2012-01-01

    For Comparative Effectiveness Research (CER) there is a need to develop scales for appraisal of available clinical research. Aims were to 1) test the feasibility of applying the pragmatic-explanatory continuum indicator summary tool and the six CER defining characteristics of the Institute of Medicine to RCTs of acupuncture for treatment of low back pain, and 2) evaluate the extent to which the evidence from these RCTs is relevant to clinical and health policy decision making. We searched Medline, the AcuTrials™ Database to February 2011 and reference lists and included full-report randomized trials in English that compared needle acupuncture with a conventional treatment in adults with non-specific acute and/or chronic low back pain and restricted to those with ≥30 patients in the acupuncture group. Papers were evaluated by 5 raters. From 119 abstracts, 44 full-text publications were screened and 10 trials (4,901 patients) were evaluated. Due to missing information and initial difficulties in operationalizing the scoring items, the first scoring revealed inter-rater and inter-item variance (intraclass correlations 0.02-0.60), which improved after consensus discussions to 0.20-1.00. The 10 trials were found to cover the efficacy-effectiveness continuum; those with more flexible acupuncture and no placebo control scored closer to effectiveness. Both instruments proved useful, but need further development. In addition, CONSORT guidelines for reporting pragmatic trials should be expanded. Most studies in this review already reflect the movement towards CER and similar approaches can be taken to evaluate comparative effectiveness relevance of RCTs for other treatments.

  11. How well do randomized trials inform decision making: systematic review using comparative effectiveness research measures on acupuncture for back pain.

    Directory of Open Access Journals (Sweden)

    Claudia M Witt

    Full Text Available For Comparative Effectiveness Research (CER there is a need to develop scales for appraisal of available clinical research. Aims were to 1 test the feasibility of applying the pragmatic-explanatory continuum indicator summary tool and the six CER defining characteristics of the Institute of Medicine to RCTs of acupuncture for treatment of low back pain, and 2 evaluate the extent to which the evidence from these RCTs is relevant to clinical and health policy decision making.We searched Medline, the AcuTrials™ Database to February 2011 and reference lists and included full-report randomized trials in English that compared needle acupuncture with a conventional treatment in adults with non-specific acute and/or chronic low back pain and restricted to those with ≥30 patients in the acupuncture group. Papers were evaluated by 5 raters.From 119 abstracts, 44 full-text publications were screened and 10 trials (4,901 patients were evaluated. Due to missing information and initial difficulties in operationalizing the scoring items, the first scoring revealed inter-rater and inter-item variance (intraclass correlations 0.02-0.60, which improved after consensus discussions to 0.20-1.00. The 10 trials were found to cover the efficacy-effectiveness continuum; those with more flexible acupuncture and no placebo control scored closer to effectiveness.Both instruments proved useful, but need further development. In addition, CONSORT guidelines for reporting pragmatic trials should be expanded. Most studies in this review already reflect the movement towards CER and similar approaches can be taken to evaluate comparative effectiveness relevance of RCTs for other treatments.

  12. Randomised controlled trial comparing hypnotherapy versus gabapentin for the treatment of hot flashes in breast cancer survivors: a pilot study

    Science.gov (United States)

    MacLaughlan David, Shannon; Salzillo, Sandra; Bowe, Patrick; Scuncio, Sandra; Malit, Bridget; Raker, Christina; Gass, Jennifer S; Granai, C O; Dizon, Don S

    2013-01-01

    Objectives To compare the efficacy of hypnotherapy versus gabapentin for the treatment of hot flashes in breast cancer survivors, and to evaluate the feasibility of conducting a clinical trial comparing a drug with a complementary or alternative method (CAM). Design Prospective randomised trial. Setting Breast health centre of a tertiary care centre. Participants 15 women with a personal history of breast cancer or an increased risk of breast cancer who reported at least one daily hot flash. Interventions Gabapentin 900 mg daily in three divided doses (control) compared with standardised hypnotherapy. Participation lasted 8 weeks. Outcome measures The primary endpoints were the number of daily hot flashes and hot flash severity score (HFSS). The secondary endpoint was the Hot Flash Related Daily Interference Scale (HFRDIS). Results 27 women were randomised and 15 (56%) were considered evaluable for the primary endpoint (n=8 gabapentin, n=7 hypnotherapy). The median number of daily hot flashes at enrolment was 4.5 in the gabapentin arm and 5 in the hypnotherapy arm. HFSS scores were 7.5 in the gabapentin arm and 10 in the hypnotherapy arm. After 8 weeks, the median number of daily hot flashes was reduced by 33.3% in the gabapentin arm and by 80% in the hypnotherapy arm. The median HFSS was reduced by 33.3% in the gabapentin arm and by 85% in the hypnotherapy arm. HFRDIS scores improved by 51.6% in the gabapentin group and by 55.2% in the hypnotherapy group. There were no statistically significant differences between groups. Conclusions Hypnotherapy and gabapentin demonstrate efficacy in improving hot flashes. A definitive trial evaluating traditional interventions against CAM methods is feasible, but not without challenges. Further studies aimed at defining evidence-based recommendations for CAM are necessary. Trial registration clinicaltrials.gov (NCT00711529). PMID:24022390

  13. A randomized trial comparing bladder volume consistency during fractionated prostate radiation therapy

    LENUS (Irish Health Repository)

    Mullaney, L.

    2014-01-10

    Organ motion is a contributory factor to the variation in location of the prostate and organs at risk during a course of fractionated prostate radiation therapy (RT). A prospective randomized controlled trial was designed with the primary endpoint to provide evidence-based bladder-filling instructions to achieve a consistent bladder volume (BV) and thus reduce the bladder-related organ motion. The secondary endpoints were to assess the incidence of acute and late genitourinary (GU) and gastrointestinal (GI) toxicity for patients and patients’ satisfaction with the bladder-filling instructions.

  14. Comparing recruitment, retention, and safety reporting among geographic regions in multinational Alzheimer's disease clinical trials.

    Science.gov (United States)

    Grill, Joshua D; Raman, Rema; Ernstrom, Karin; Aisen, Paul; Dowsett, Sherie A; Chen, Yun-Fei; Liu-Seifert, Hong; Hake, Ann Marie; Miller, David S; Doody, Rachelle S; Henley, David B; Cummings, Jeffrey L

    2015-01-01

    Most Alzheimer's disease (AD) clinical trials enroll participants multinationally. Yet, few data exist to guide investigators and sponsors regarding the types of patients enrolled in these studies and whether participant characteristics vary by region. We used data derived from four multinational phase III trials in mild to moderate AD to examine whether regional differences exist with regard to participant demographics, safety reporting, and baseline scores on the Mini Mental State Examination (MMSE), the 11-item Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-cog11), the Clinical Dementia Rating scale Sum of Boxes (CDR-SB), the Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL), and the Neuropsychiatric Inventory (NPI). We assigned 31 participating nations to 7 geographic regions: North America, South America/Mexico, Western Europe/Israel, Eastern Europe/Russia, Australia/South Africa, Asia, and Japan. North America, Western Europe/Israel, and Australia/South Africa enrolled similar proportions of men, apolipoprotein E ε4 carriers, and participants with spouse study partners, whereas Asia, Eastern Europe/Russia, and South America/Mexico had lower proportions for these variables. North America and South America/Mexico enrolled older subjects, whereas Asia and South America/Mexico enrolled less-educated participants than the remaining regions. Approved AD therapy use differed among regions (range: 73% to 92%) and was highest in North America, Western Europe/Israel, and Japan. Dual therapy was most frequent in North America (48%). On the MMSE, North America, Western Europe/Israel, Japan, and Australia/South Africa had higher (better) scores, and Asia, South America/Mexico, and Eastern Europe/Russia had lower scores. Eastern Europe/Russia had more impaired ADAS-cog11 scores than all other regions. Eastern Europe/Russia and South America/Mexico had more impaired scores for the ADCS-ADL and the CDR-SB. Mean scores for

  15. Randomized clinical trial comparing an oral carbohydrate beverage with placebo before laparoscopic cholecystectomy

    DEFF Research Database (Denmark)

    Bisgaard, T; Kristiansen, V B; Hjortsø, N C

    2004-01-01

    evaluated the clinical effects of a preoperative carbohydrate beverage in patients undergoing laparoscopic cholecystectomy. METHODS: Ninety-four patients undergoing laparoscopic cholecystectomy were included in a randomized clinical trial. Patients were randomized to receive 800 ml of an iso-osmolar 12.......5 per cent carbohydrate-rich beverage the evening before operation (100 g carbohydrate) and another 400 ml (50 g carbohydrate) 2 h before initiation of anaesthesia, or the same volume of a placebo beverage. The primary endpoint was general well-being the day after operation. Patients were evaluated from...

  16. Protocol design and current status of CLIVIT: a randomized controlled multicenter relevance trial comparing clips versus ligatures in thyroid surgery

    Directory of Open Access Journals (Sweden)

    Wollermann C

    2006-09-01

    Full Text Available Abstract Background Annually, more than 90000 surgical procedures of the thyroid gland are performed in Germany. Strategies aimed at reducing the duration of the surgical procedure are relevant to patients and the health care system especially in the context of reducing costs. However, new techniques for quick and safe hemostasis have to be tested in clinically relevance randomized controlled trials before a general recommendation can be given. The current standard for occlusion of blood vessels in thyroid surgery is ligatures. Vascular clips may be a safe alternative but have not been investigated in a large RCT. Methods/design CLIVIT (Clips versus Ligatures in Thyroid Surgery is an investigator initiated, multicenter, patient-blinded, two-group parallel relevance randomized controlled trial designed by the Study Center of the German Surgical Society. Patients scheduled for elective resection of at least two third of the gland for benign thyroid disease are eligible for participation. After surgical exploration patients are randomized intraoperatively into either the conventional ligature group, or into the clip group. The primary objective is to test for a relevant reduction in operating time (at least 15 min when using the clip technique. Since April 2004, 121 of the totally required 420 patients were randomized in five centers. Discussion As in all trials the different forms of bias have to be considered, and as in this case, a surgical trial, the role of surgical expertise plays a key role, and will be documented and analyzed separately. This is the first randomized controlled multicenter relevance trial to compare different vessel occlusion techniques in thyroid surgery with adequate power and other detailed information about the design as well as framework. If significant, the results might be generalized and may change the current surgical practice.

  17. Is the large simple trial design used for comparative, post-approval safety research? A review of a clinical trials registry and the published literature.

    Science.gov (United States)

    Reynolds, Robert F; Lem, Joanna A; Gatto, Nicolle M; Eng, Sybil M

    2011-10-01

    Post-approval, observational drug safety studies face well known difficulties in controlling for confounding, particularly confounding by indication for drug use. A study design that addresses confounding by indication is the large simple trial (LST). LSTs are characterized by large sample sizes, often in the thousands; broad entry criteria consistent with the approved medication label; randomization based on equipoise, i.e. neither physician nor patient believes that one treatment option is superior; minimal, streamlined data collection requirements; objectively-measured endpoints (e.g. death, hospitalization); and follow-up that minimizes interventions or interference with normal clinical practice. In theory then, the LST is a preferred study design for drug and vaccine safety research because it controls for biases inherent to observational research while still providing results that are generalizable to 'real-world' use. To evaluate whether LSTs are used for comparative safety evaluation and if the design is, in fact, advantageous compared with other designs, we conducted a review of the published literature (1949 through 31 December 2010) and the ClinicalTrials.gov registry (2000 through 31 December 2010). Thirteen ongoing or completed safety LSTs were identified. The design has rarely been used in comparative drug safety research, which is due to the operational, financial and scientific hurdles of implementing the design. The studies that have been completed addressed important clinical questions and, in some cases, led to re-evaluation of medical practice. We conclude the design has demonstrated utility for comparative safety research of medicines and vaccines if the necessary scientific and operational conditions for its use are met.

  18. Adaptation and dissemination of an evidence-based obesity prevention intervention: design of a comparative effectiveness trial.

    Science.gov (United States)

    Buscemi, Joanna; Odoms-Young, Angela; Stolley, Melinda L; Blumstein, Lara; Schiffer, Linda; Berbaum, Michael L; McCaffrey, Jennifer; Montoya, Anastasia McGee; Braunschweig, Carol; Fitzgibbon, Marian L

    2014-07-01

    Low-income youth are at increased risk for excess weight gain. Although evidence-based prevention programs exist, successful adaptation to provide wide dissemination presents a challenge. Hip-Hop to Health (HH) is a school-based obesity prevention intervention that targets primarily preschool children of low-income families. In a large randomized controlled trial, HH was found to be efficacious for prevention of excessive weight gain. The Expanded Food and Nutrition Education Program (EFNEP) and the Supplemental Nutrition Assistance Program-Education (SNAP-Ed) are USDA-funded nutrition education programs offered to low-income families, and may provide an ideal platform for the wide dissemination of evidence-based obesity prevention programs. A research-practice partnership was established in order to conduct formative research to guide the adaptation and implementation of HH through EFNEP and SNAP-Ed. We present the design and method of a comparative effectiveness trial that will determine the efficacy of HH when delivered by peer educators through these programs compared to the standard EFNEP and SNAP-Ed nutrition education (NE) curriculum. Results from this trial will inform larger scale dissemination. The dissemination of HH through government programs has the potential to increase the reach of efficacious obesity prevention programs that target low-income children and families. Copyright © 2014 Elsevier Inc. All rights reserved.

  19. A randomized comparative trial on the therapeutic efficacy of topical aloe vera and Calendula officinalis on diaper dermatitis in children.

    Science.gov (United States)

    Panahi, Yunes; Sharif, Mohamad Reza; Sharif, Alireza; Beiraghdar, Fatemeh; Zahiri, Zahra; Amirchoopani, Golnoush; Marzony, Eisa Tahmasbpour; Sahebkar, Amirhossein

    2012-01-01

    Diaper dermatitis (DD) is a common inflammatory disorder among children and infants. The objective of the present randomized and double-blind trial was to compare the therapeutic efficacies of aloe vera cream and Calendula officinalis ointment on the frequency and severity of DD in children. Sixty-six infants with DD (aged Calendula ointment (n = 34). Infants were treated with these drugs 3 times a day for 10 days. The severity of dermatitis was graded at baseline as well as at the end of trial using a 5-point scale. The adverse effects of study medications were assessed during the trial. Although improvement in the severity of DD was observed in both treatment groups (P Calendula ointment had significantly fewer rash sites compared to aloe group (P = 0.001). No adverse effect was reported from either of the medications. The evidence from this study suggests that topical aloe and in particular Calendula could serve as safe and effective treatment for the treatment of diaper dermatitis in infants.

  20. A pragmatic randomised controlled trial to compare antidepressants with a community-based psychosocial intervention for the treatment of women with postnatal depression: the RESPOND trial.

    Science.gov (United States)

    Sharp, D J; Chew-Graham, C; Tylee, A; Lewis, G; Howard, L; Anderson, I; Abel, K; Turner, K M; Hollinghurst, S P; Tallon, D; McCarthy, A; Peters, T J

    2010-09-01

    To evaluate clinical effectiveness at 4 weeks of antidepressant therapy for mothers with postnatal depression (PND) compared with general supportive care; to compare outcome at 18 weeks of those randomised to antidepressant therapy with those randomised to listening visits as the first intervention (both groups were to be allowed to receive the alternative intervention after 4 weeks if the woman or her doctor so decided); and to assess acceptability of antidepressants and listening visits to users and health professionals. A pragmatic two-arm individually randomised controlled trial. Participants were recruited from 77 general practices: 21 in Bristol, 21 in south London and 35 in Manchester. A total of 254 women who fulfilled International Classification of Diseases version 10 criteria for major depression in the first 6 postnatal months were recruited and randomised. Women were randomised to receive either an antidepressant, usually a selective serotonin reuptake inhibitor prescribed by their general practitioner (GP), or non-directive counselling (listening visits) from a specially trained research health visitor (HV). The trial was designed to compare antidepressants with general supportive care for the first 4 weeks, after which women allocated to listening visits commenced their sessions. It allowed for women to receive the alternative intervention if they had not responded to their allocated intervention or wished to change to, or add in, the alternative intervention at any time after 4 weeks. The duration of the trial was 18 weeks. Primary outcome, measured at 4 weeks and 18 weeks post randomisation, was the proportion of women improved on the Edinburgh Postnatal Depression Scale (EPDS), that is scoring antidepressants compared with listening visits, which started after the 4-week follow-up, i.e. after 4 weeks of general supportive care [primary intention-to-treat (ITT), 45% versus 20%; odds ratio (OR) 3.4, 95% confidence interval (CI) 1.8 to 6.5, p

  1. Urinary tract infections in women with stress urinary incontinence treated with transobturator suburethral tape and benefit gained from the sublingual polibacterial vaccine.

    Science.gov (United States)

    Lorenzo Gómez, María F; Collazos Robles, Rafael E; Virseda Rodríguez, Álvaro J; García Cenador, María B; Mirón Canelo, José A; Padilla Fernández, Bárbara

    2015-08-01

    Stress urinary incontinence (SUI) and recurrent urinary tract infections (RUTIs) are highly prevalent diseases. Our purpose was to investigate the relationship between RUTIs and surgical correction of SUI with transobturator suburethral tape (TOT) and to describe the benefit gained from a sublingual polibacterial preparation on RUTIs developed after TOT. A retrospective study was performed on 420 women who underwent TOT surgery due to SUI between April 2003 and October 2011. Group A: patients without urinary tract infections (UTIs) before TOT (n = 294). Group B: patients with UTIs before TOT (n = 126). age, personal history, number of UTIs/month prior to and after surgery, appearance of urgent urinary incontinence (UUI) with or without UTIs, response to International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) and Short Form 36 (SF-36) questionnaires. Group A: 85% dry; 5% UUI; 4% de novo UTIs with good response to antibiotics over 6 days. No RUTIs during the follow-up period, 2% with sporadic UTIs. Group B: 47.61% RUTIs; 52.39% sporadic UTIs; greater incidence of diabetes mellitus (p < 0.0025) and smoking (p < 0.0031) than group A. After TOT: 79.36% dry; 10% RUTIs. After treatment with antibiotics for 6 days and bacterial preparation for 3 months, 82% of patients did not have a UTI anymore. Postoperative cystourethrogram revealed 38% of nondiagnosed cystoceles before TOT. No patient had a postvoiding volume greater than 100 cm(3) after TOT. Improvement of ICIQ-SF (p < 0.001) and SF-36 (p < 0.0004) in both groups. After eliminating bias associated with the tape, the technique and the surgeon's skills, SUI correction may decrease the number of UTIs and improve the quality of life. UTIs disappeared in 82% of patients with RUTIs after TOT.

  2. Outcome of Treatment of Anterior Vaginal Wall Prolapse and Stress Urinary Incontinence with Transobturator Tension-Free Vaginal Mesh (Prolift and Concomitant Tension-Free Vaginal Tape-Obturator

    Directory of Open Access Journals (Sweden)

    Sameh Azazy

    2008-12-01

    Full Text Available Objective. It is to assess the feasibility, effectiveness, and safety of transobturator tension-free vaginal mesh (Prolift and concomitant tension-free vaginal tape-obturator (TVT-O system as a treatment of female anterior vaginal wall prolapse associated with stress urinary incontinence (SUI. Patients and Methods. Between December 2006 and July 2007, 20 patients with anterior genital prolapse and voiding dysfunction were treated with the transobturator tension-free vaginal mesh (Prolift and concomitant tension-free vaginal tape-obturator (TVT-O. Sixteen patients had stress urinary incontinence and 4 patients were considered at risk for development of de novo stress incontinence after the prolapse is repaired. All patients underwent a complete urodynamic assessment. All the patients underwent pelvic examination 4–6 weeks after the operation, and anatomical and functional outcomes were recorded. Results. Twenty cystocoeles were repaired: 6 grade II, 12 grade III, and 2 grade IV. There were no vessel or bladder injuries. Eighteen patients had optimal anatomic results and 2 patients had persistent asymptomatic stage I prolapse. Conclusion. These preliminary results suggest that Prolift system offers a safe and effective treatment for female anterior vaginal wall prolapse. However, a long-term followup is necessary in order to support the good result maintenance.

  3. A pilot randomized trial comparing long-term effects of red and white wines on biomarkers of atherosclerosis (in vino veritas: IVV trial).

    Science.gov (United States)

    Taborsky, M; Ostadal, P; Petrek, M

    2012-01-01

    Since early 90', growing body of evidence indicates that the Mediterranean diet with mild to moderate consumption of wine, mostly red wine, has a protective effect on cardiovascular diseases. Several mechanisms have been discussed to participate in the beneficial effect of red wine, such as antioxidant or vasodilating activity. However, later it has been shown that also other alcoholic beverages have a protective effect on atherosclerosis. Up to now, data from the prospective, long-term, head-to-head comparisons of the effects of different drinks on markers of atherosclerosis are insufficient. The IVV (in vino veritas) study is a long-term, prospective, multicenter, randomized trial comparing the effect of red and white wines on the markers of atherosclerosis. One hundred and twenty healthy subjects with mild to moderate risk of atherosclerosis will be randomized to regular consumption of red wine (Pinot Noir) or white wine (Chardonnay-Pinot) for one year. The primary endpoint is the level of HDL-cholesterol at one year, while secondary endpoints are levels of other markers of atherosclerosis (LDL-cholesterol, C-reactive protein, myeloperoxidase, advanced oxidation protein product, interleukins 6 and 18, matrix metalloproteinases, glutathione s-transferase, monocyte chemoattractant protein 1, soluble CD40L). The IVV trial is the first study focusing on the long-term prospective comparison of the effects of red and white wines consumption on HDL-cholesterol and other markers of atherosclerosis. Results of the IVV trial may extend our understanding of the widely discussed "French paradox" (Tab. 1, Ref. 21)

  4. The Head Injury Retrieval Trial (HIRT): a single-centre randomised controlled trial of physician prehospital management of severe blunt head injury compared with management by paramedics only.

    Science.gov (United States)

    Garner, Alan A; Mann, Kristy P; Fearnside, Michael; Poynter, Elwyn; Gebski, Val

    2015-11-01

    Advanced prehospital interventions for severe brain injury remains controversial. No previous randomised trial has been conducted to evaluate additional physician intervention compared with paramedic only care. Participants in this prospective, randomised controlled trial were adult patients with blunt trauma with either a scene GCS score definition), or GCSdefinition). Patients were randomised to either standard ground paramedic treatment or standard treatment plus a physician arriving by helicopter. Patients were evaluated by 30-day mortality and 6-month Glasgow Outcome Scale (GOS) scores. Due to high non-compliance rates, both intention-to-treat and as-treated analyses were preplanned. 375 patients met the original definition, of which 197 was allocated to physician care. Differences in the 6-month GOS scores were not significant on intention-to-treat analysis (OR 1.11, 95% CI 0.74 to 1.66, p=0.62) nor was the 30-day mortality (OR 0.91, 95% CI 0.60 to 1.38, p=0.66). As-treated analysis showed a 16% reduction in 30-day mortality in those receiving additional physician care; 60/195 (29%) versus 81/180 (45%), pdefinition, of which 182 were allocated to physician care. The 6-month GOS scores were not significantly different on intention-to-treat analysis (OR 1.14, 95% CI 0.73 to 1.75, p=0.56) nor was the 30-day mortality (OR 1.05, 95% CI 0.66 to 1.66, p=0.84). As-treated analyses were also not significantly different. This trial suggests a potential mortality reduction in patients with blunt trauma with GCSdefinition only). Confirmatory studies which also address non-compliance issues are needed. NCT00112398. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  5. Rationale for a randomized controlled trial comparing two prophylaxis regimens in adults with severe hemophilia A: the Hemophilia Adult Prophylaxis Trial

    Science.gov (United States)

    Ragni, Margaret V

    2011-01-01

    A major goal of comprehensive hemophilia care is to prevent occurrence of bleeds by prophylaxis or regular preventive factor, one or more times weekly. Although prophylaxis is effective in reducing bleeding and joint damage in children, whether it is necessary to continue into adulthood is not known. The purpose of this article is to describe a Phase III randomized controlled trial to evaluate prophylaxis comparing two dose regimens in adults with severe hemophilia A. I hypothesize that adults with mature cartilage and joints are less susceptible to joint bleeds and joint damage, and that once-weekly recombinant factor VIII prophylaxis, with up to two rescue doses per week, is as effective as thrice-weekly prophylaxis in reducing bleeding frequency, but less costly and more acceptable, with higher quality of life. The ultimate goal of this project is to determine whether once-weekly prophylaxis is any worse than thrice-weekly prophylaxis in reducing joint bleeding frequency, while potentially utilizing less factor, at lower cost, leading to a better quality of life. This is an innovative concept, as it challenges the current paradigm of thrice-weekly prophylaxis in adults, which is based on dosing in children. Furthermore, this trial will assess interdose thrombin generation, a novel tissue factor-based assay of hemostasis, to determine if individualized thrombin generation can predict more individualized prophylaxis dosing, which would be practice changing. PMID:21939418

  6. COLOR II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer

    DEFF Research Database (Denmark)

    Buunen, M; Bonjer, H J; Hop, W C J

    2009-01-01

    in both treatment groups. Most tumors are located in the mid-rectum (41%). CONCLUSION: Laparoscopic surgery in the treatment of rectal cancer is feasible. The results and safety of laparoscopic surgery in the treatment of rectal cancer remain unknown, but are subject of interim analysis within the COLOR...... clinical trial. Currently 27 hospitals from Europe, South Korea and Canada are including patients. The primary endpoint is loco-regional recurrence rate three years post-operatively. Secondary endpoints cover quality of life, overall and disease free survival, post-operative morbidity and health economy...... analysis. RESULTS: By July 2008, 27 hospitals from the Netherlands, Belgium, Germany, Sweden, Spain, Denmark, South Korea and Canada had included 739 patients. The intra-operative conversion rate in the laparoscopic group was 17%. Distribution of age, location of the tumor and radiotherapy were equal...

  7. Comparative Field Trial of Alternative Vector Control Strategies for Non-Domiciliated Triatoma dimidiata

    Science.gov (United States)

    Ferral, Jhibran; Chavez-Nuñez, Leysi; Euan-Garcia, Maria; Ramirez-Sierra, Maria Jesus; Najera-Vazquez, M. Rosario; Dumonteil, Eric

    2010-01-01

    Chagas disease is a major vector-borne disease, and regional initiatives based on insecticide spraying have successfully controlled domiciliated vectors in many regions. Non-domiciliated vectors remain responsible for a significant transmission risk, and their control is a challenge. We performed a proof-of-concept field trial to test alternative strategies in rural Yucatan, Mexico. Follow-up of house infestation for two seasons following the interventions confirmed that insecticide spraying should be performed annually for the effective control of Triatoma dimidiata; however, it also confirmed that insect screens or long-lasting impregnated curtains may represent good alternative strategies for the sustained control of these vectors. Ecosystemic peridomicile management would be an excellent complementary strategy to improve the cost-effectiveness of interventions. Because these strategies would also be effective against other vector-borne diseases, such as malaria or dengue, they could be integrated within a multi-disease control program. PMID:20064997

  8. The role of visual awareness for conflict adaptation in the masked priming task: comparing block-wise adaptation with trial-by-trial adaptation

    OpenAIRE

    Hasegawa, Kunihiro; Takahashi, Shin’ya

    2014-01-01

    This study investigated the role of participants’ visual awareness in the block-wise and the trial-by-trial adaptations. We employed a subliminal response compatibility task in which a prime arrow was briefly presented before the target arrow, and the participants were requested to indicate the direction of the target arrow. The direction of the prime and direction of the target were either the same (compatible trial) or different (incompatible trial). To examine block-wise adaptation, two bl...

  9. A multicenter randomized controlled trial comparing pancreatic leaks after TissueLink versus SEAMGUARD after distal pancreatectomy (PLATS) NCT01051856.

    Science.gov (United States)

    Shubert, Christopher R; Ferrone, Christina R; Fernandez-Del Castillo, Carlos; Kendrick, Michael L; Farnell, Michael B; Smoot, Rory L; Truty, Mark J; Que, Florencia G

    2016-11-01

    Pancreatic leak is common after distal pancreatectomy. This trial sought to compare TissueLink closure of the pancreatic stump to that of SEAMGUARD. A multicenter, prospective, trial of patients undergoing distal pancreatectomy randomized to either TissueLink or SEAMGUARD. Enrollment was closed early due to poor accrual. Overall, 67 patients were enrolled, 35 TissueLink and 32 SEAMGUARD. The two groups differed in American Society of Anesthesiologist class and diagnosis at baseline and were relatively balanced otherwise. Overall, 37 of 67 patients (55%) experienced a leak of any grade, 15 (46.9%) in the SEAMGUARD arm and 22 (62.9%) in the TissueLink arm (P = 0.19). The clinically significant leak rate was 17.9%; 22.9% for TissueLink and 12.5% for SEAMGUARD (P = 0.35). There were no statistically significant differences in major or any pancreatic fistula-related morbidity between the two groups. This is the first multicentered randomized trial evaluating leak rate after distal pancreatectomy between two common transection methods. Although a difference in leak rates was observed, it was not statistically significant and therefore does not provide evidence of the superiority of one technique over the other. Choice should remain based on surgeon comfort, experience, and pancreas characteristics. Copyright © 2016 Elsevier Inc. All rights reserved.

  10. Focus on Function – a randomized controlled trial comparing two rehabilitation interventions for young children with cerebral palsy

    Directory of Open Access Journals (Sweden)

    Russell Dianne

    2007-09-01

    Full Text Available Abstract Background Children with cerebral palsy receive a variety of long-term physical and occupational therapy interventions to facilitate development and to enhance functional independence in movement, self-care, play, school activities and leisure. Considerable human and financial resources are directed at the "intervention" of the problems of cerebral palsy, although the available evidence supporting current interventions is inconclusive. A considerable degree of uncertainty remains about the appropriate therapeutic approaches to manage the habilitation of children with cerebral palsy. The primary objective of this project is to conduct a multi-site randomized clinical trial to evaluate the efficacy of a task/context-focused approach compared to a child-focused remediation approach in improving performance of functional tasks and mobility, increasing participation in everyday activities, and improving quality of life in children 12 months to 5 years of age who have cerebral palsy. Method/Design A multi-centred randomized controlled trial research design will be used. Children will be recruited from a representative sample of children attending publicly-funded regional children's rehabilitation centers serving children with disabilities in Ontario and Alberta in Canada. Target sample size is 220 children with cerebral palsy aged 12 months to 5 years at recruitment date. Therapists are randomly assigned to deliver either a context-focused approach or a child-focused approach. Children follow their therapist into their treatment arm. Outcomes will be evaluated at baseline, after 6 months of treatment and at a 3-month follow-up period. Outcomes represent the components of the International Classification of Functioning, Disability and Health, including body function and structure (range of motion, activities (performance of functional tasks, motor function, participation (involvement in formal and informal activities, and environment (parent

  11. Report of a randomized trial of d(15)+Be neutrons compared with megavoltage X ray therapy of bladder cancer

    International Nuclear Information System (INIS)

    Duncan, W.; Arnott, S.J.; Jack, W.J.; MacDougall, R.H.; Quilty, P.M.; Rodger, A.; Kerr, G.R.; Williams, J.R.

    1985-01-01

    The results of a randomized trial of d(15)+Be neutrons compared with 4 or 6 MV photons for the treatment of transitional cell carcinoma of the bladder. Between December 1978 and December 1981, 113 patients were accrued, 53 allocated to be treated by neutrons and 60 by photons. Complete local tumor regression was observed in 64% of patients treated by neutrons and 62% treated by photons. Recurrent cancer was subsequently confirmed in 31% of patients, similar in both treatment groups. There was no significant difference in the control rates by T stage between the two treatment groups. Late morbidity was significantly worse in patients treated by neutrons. Following neutron therapy, 78% of patients had serious late morbidity in at least one tissue compared with 38% in the group treated by photons. Survival was significantly better in the photon treated group 45.3% (+/- 11%) at 5 years compared with 12% (+/- 6%) after neutron therapy

  12. Comparative Efficacy of Insecticides on Bactrocera tryoni and Zeugodacus cucumis (Diptera: Tephritidae) in Laboratory and Semifield Trials in Fruiting Vegetables.

    Science.gov (United States)

    Senior, L J; Missenden, B P; Wright, C

    2017-08-01

    In-field management of Bactrocera tryoni (Froggatt) and Zeugodacus cucumis (French) (Diptera: Tephritidae) in fruiting vegetable crops has relied almost exclusively on organophosphate cover sprays. Laboratory and semifield trials were performed to compare a number of alternative insecticides for efficacy against these species. A novel semifield method was used whereby the insecticides were applied to crops as cover sprays under field conditions, and treated plants bearing fruit were transferred to large cages and exposed to fruit flies. Efficacy was assessed in terms of numbers of pupae developing from treated fruit. A laboratory cage method was also used to assess effects on adult mortality and comparative effects of 1- and 3-d-aged residues. The neonicotinoids clothianidin and thiacloprid were very effective against B. tryoni and Z. cucumis. Clothianidin was the only insecticide other than dimethoate to affect adult mortality. The synthetic pyrethroid alpha-cypermethrin was also very effective, particularly in semifield trials, although higher incidence of aphid and whitefly infestation was observed in this treatment compared to others. Cyantraniliprole was effective against B. tryoni, but less effective against Z. cucumis. Imidacloprid, bifenthrin, spinetoram, and abamectin were all relatively less effective, although all demonstrated a suppressive effect. © Commonwealth of Australia, Department of Agriculture and Fisheries, 2017.

  13. Randomized controlled trial comparing carbetocin, misoprostol, and oxytocin for the prevention of postpartum hemorrhage following an elective cesarean delivery.

    Science.gov (United States)

    Elbohoty, Ahmed E H; Mohammed, Walid E; Sweed, Mohamed; Bahaa Eldin, Ahmed M; Nabhan, Ashraf; Abd-El-Maeboud, Karim H I

    2016-09-01

    To compare the effectiveness and safety of carbetocin, misoprostol, and oxytocin for the prevention of postpartum hemorrhage following cesarean deliveries. A double-blind randomized controlled trial enrolled patients with a singleton pregnancy scheduled for an elective cesarean delivery at a maternity hospital in Cairo, Egypt, between October 1, 2012 and June 30, 2013. Participants were randomized using a computer-generated sequence to receive treatment with carbetocin, misoprostol, or oxytocin. The primary outcome was the occurrence of uterine atony necessitating additional uterotonics. Per-protocol analyses were performed. Patients, investigators, and data analysts were masked to treatment assignments. The present study enrolled 263 patients; data were analyzed from 88 patients treated with carbetocin, 89 treated with misoprostol, and 86 women treated with oxytocin. Further uterotonics were needed for the treatment of 5 (6%) patients who were treated with carbetocin, 20 (22%) patients treated with misoprostol, and 11 (13%) patients treated with oxytocin. In the prevention of uterine atony, carbetocin was comparable with oxytocin (RR 0.41, 95%CI 0.14-1.25) and superior to misoprostol (RR 0.21, 95%CI 0.07-0.58). Additional uterotonics were needed less frequently by patients treated with carbetocin. Carbetocin was comparable to oxytocin and superior to misoprostol in the prevention of uterine atony following an elective cesarean delivery. ClinicalTrials.gov: NCT02053922. Copyright © 2016 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

  14. Collagen hemostat significantly reduces time to hemostasis compared with cellulose: COBBANA, a single-center, randomized trial.

    Science.gov (United States)

    Qerimi, Bekim; Baumann, Petra; Hüsing, Johannes; Knaebel, Hanns-Peter; Schumacher, Hardy

    2013-06-01

    This single-center, randomized trial compares the hemostatic effectiveness of microfibrillar collagen and oxidized cellulose in arterial bypass surgery. In patients undergoing arterial bypass surgery, 2 hemostats, microfibrillar collagen and oxidized cellulose, were randomly used to achieve hemostasis. The primary endpoint was the time to hemostasis. The secondary endpoints were the complication rate, mortality, number of hemostats required, handling, and adhesion. Collagen achieved hemostasis significantly faster than cellulose, with considerably less hemostats. In addition, its ease of use was rated substantially better. In arterial bypass surgery, microfibrillar collagen is more effective than oxidized cellulose in achieving hemostasis. Copyright © 2013 Elsevier Inc. All rights reserved.

  15. At what price? A cost-effectiveness analysis comparing trial of labour after previous Caesarean versus elective repeat Caesarean delivery.

    LENUS (Irish Health Repository)

    Fawsitt, Christopher G

    2013-01-01

    Elective repeat caesarean delivery (ERCD) rates have been increasing worldwide, thus prompting obstetric discourse on the risks and benefits for the mother and infant. Yet, these increasing rates also have major economic implications for the health care system. Given the dearth of information on the cost-effectiveness related to mode of delivery, the aim of this paper was to perform an economic evaluation on the costs and short-term maternal health consequences associated with a trial of labour after one previous caesarean delivery compared with ERCD for low risk women in Ireland.

  16. Clinical benefit of intra-articular saline as a comparator in clinical trials of knee osteoarthritis treatments

    DEFF Research Database (Denmark)

    Altman, Roy D; Devji, Tahira; Bhandari, Mohit

    2016-01-01

    OBJECTIVES: Hyaluronic acid and corticosteroids are common intra-articular (IA) therapies widely used for the management of mild to moderate knee osteoarthritis (OA). Many trials evaluating the efficacy of IA administered therapies commonly use IA saline injections as a placebo comparator arm...... in the meta-analysis. Based on data with moderate inconsistency IA saline was found to significantly improve short-term knee pain in 32 studies involving 1705 patients (SMD = -0.68; 95% CI: -0.78 to -0.57; P injection...... with saline in 19 studies involving 1445 patients (SMD = -0.61; 95% CI: -0.76 to -0.45; P injection with saline...

  17. A randomized trial comparing digital and live lecture formats [ISRCTN40455708

    Directory of Open Access Journals (Sweden)

    Laird-Fick Heather S

    2004-11-01

    Full Text Available Abstract Background Medical education is increasingly being conducted in community-based teaching sites at diverse locations, making it difficult to provide a consistent curriculum. We conducted a randomized trial to assess whether students who viewed digital lectures would perform as well on a measure of cognitive knowledge as students who viewed live lectures. Students' perceptions of the digital lecture format and their opinion as whether a digital lecture format could serve as an adequate replacement for live lectures was also assessed. Methods Students were randomized to either attend a lecture series at our main campus or view digital versions of the same lectures at community-based teaching sites. Both groups completed the same examination based on the lectures, and the group viewing the digital lectures completed a feedback form on the digital format. Results There were no differences in performance as measured by means or average rank. Despite technical problems, the students who viewed the digital lectures overwhelmingly felt the digital lectures could replace live lectures. Conclusions This study provides preliminary evidence digital lectures can be a viable alternative to live lectures as a means of delivering didactic presentations in a community-based setting.

  18. Trials

    Directory of Open Access Journals (Sweden)

    Michele Fornaro

    2010-01-01

    Full Text Available Mental Retardation (MR is a developmental disability characterized by impairments in adaptive daily life skills and difficulties in social and interpersonal functioning. Since multiple causes may contribute to MR, associated clinical pictures may vary accordingly. Nevertheless, when psychiatric disorders as Treatment Resistant Depression (TRD and/or alcohol abuse co-exist, their proper detection and management is often troublesome, essentially due to a limited vocabulary MR people could use to describe their symptoms, feelings and concerns, and the lack of reliable screening tools. Furthermore, MR people are among the most medicated subjects, with (over prescription of antidepressants and/or typical antipsychotics being the rule rather than exception. Thus, treatment resistance or even worsening of depression, constitute frequent occurrences. This report describes the case of a person with MR who failed to respond to repetitive trials of antidepressant monotherapies, finally recovering using aripiprazole to fluvoxamine augmentation upon consideration of a putative bipolar diathesis for “agitated” TRD. Although further controlled investigations are needed to assess a putative bipolar diathesis in some cases of MR associated to TRD, prudence is advised in the long-term prescription of antidepressant monotherapies in such conditions.

  19. Prospective Randomized Controlled Trial Comparing Plasmakinetic Vaporesection and Conventional Transurethral Resection of the Prostate

    Directory of Open Access Journals (Sweden)

    Berry Tat-Chow Fung

    2005-01-01

    Conclusion: PKVP achieved comparable results to traditional TURP and was an effective and safe procedure. However, it did not demonstrate obvious advantages over TURP in this acute regional hospital regular TURP list setting.

  20. Comparative effects of meditation and exercise on physical and psychosocial health outcomes: a review of randomized controlled trials.

    Science.gov (United States)

    Edwards, Meghan K; Loprinzi, Paul D

    2017-11-27

    No review papers have examined studies that have directly compared non-active forms of meditation with exercise to evaluate effects on physical or psychosocial outcomes, which was the purpose of this paper. Studies were included if they had a randomized controlled trial (RCT) design, included a non-active form of meditation and exercise as intervention arms, and evaluated physical or psychosocial outcomes. The quality of included RCTs was rated using the Cochrane Collaboration's tool for assessing risk of bias in randomized trials. Five RCTs met the inclusion criteria. The total sample size across all studies was N = 325. Of the main outcomes assessed across the five studies, meditation was shown to be more effective than the exercise comparison arm when evaluating the psychosocial outcomes of anxiety, altruism, and life changes. Additionally, meditation was more effective at reducing chronic neck pain at rest and pain-related bothersomeness. Exercise, however, was more effective in improving physical health-related quality of life, HDL and LDL cholesterol, and fasting blood glucose levels. The interventions were found to be comparable when evaluating the outcomes of well-being, ethanol consumption, and perceived stress levels. Four of the evaluated studies were determined to have an overall 'unclear' risk of bias and one study was found to have a 'high' risk of bias. Exercise and non-active meditation may uniquely influence various health-related outcomes. A continued exploration of the effects of exercise and non-active meditation in controlled trials may yield a better understanding of their benefits.

  1. Effects of Letrozole Compared with Danazol on Patients with Confirmed Endometriosis: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Navid Koleini

    2010-01-01

    Full Text Available Background: Letrozole is an aromatase inhibitor which can decrease estrogen production inperipheral tissues and endometriosis. Danazol, as an androgen, inhibits estrogen production inovaries and recently has been introduced as an aromatase inhibitor. This study was designed tocompare the effects of Danazol with Letrozole on endometriosis symptom relief.Materials and Methods: This study was a randomized clinical trial in which 105 patients withconfirmed endometriosis were randomly assigned to one of three groups. Group 1 received Letrozoletablets (2.5 mg/day, calcium (1000 mg/day and vitamin D (800 IU/day. Group 2 received Danazoltablets (600 mg/day, calcium (1000 mg/day and vitamin D (800 IU/day. Group 3 (placebo groupwere assigned to take two calcium tablets daily (500 mg/tablet and vitamin D (800 IU/day. Pelvicpain, dysmenorrhea and dyspareunia were assessed in participants at baseline and monthly duringthe study for a total of six months. Data were analyzed via SPSS version 15 software with Freidmanand Wilcoxon tests.Results: Mean age in three groups has no significant difference. Of the 105 participants who wereenrolled in this study, 38 patients were assigned to group 1 (Letrozole group, 37 patients in group 2(Danazol group and 31 patients were placed in group 3 (placebo group. This study showed that themean scores for chronic pelvic pain, dysmenorrhea and dyspareunia for the Letrozole group wereless than the Danazol and placebo groups.Conclusion: This study showed that Letrozole can be more effective than Danazol for reducingchronic pelvic pain, dyspareunia and dysmenorrhea in patients suffering from recurrent endometriosis(Registeration Number: IRCT138812043414N1.

  2. Manual and manipulative therapy compared to night splint for symptomatic hallux abducto valgus: an exploratory randomised clinical trial.

    Science.gov (United States)

    du Plessis, Morne; Zipfel, Bernhard; Brantingham, James W; Parkin-Smith, Gregory F; Birdsey, Paul; Globe, Gary; Cassa, Tammy K

    2011-06-01

    Hallux abducto valgus (HAV) is a frequent cause of great toe pain and disability, yet common treatments are only supported by mixed or equivocal research findings. Surgery often only provides modest improvement and post-surgery complications may significantly hamper outcomes, implying the need for trials testing conservative treatment, such as manual and manipulative therapy, particularly in cases where surgery may be contraindicated or premature. The purpose of this exploratory trial was to test an innovative protocol of manual and manipulative therapy (MMT) and compare it to standard care of a night splint(s) for symptomatic mild to moderate HAV, with a view gather insight into the effectiveness of MMT and inform the design of a definitive trial. Parallel-group randomised trial set in an out-patient teaching clinic. A convenience sample of 75 patients was assessed for eligibility, with 30 participants (15 per group) being consented and randomly allocated to either the control group (standard care with a night splint) or the experimental group (MMT). Participants in the control group used a night splint(s) and those in the experimental group (MMT) received a structured protocol of MMT, with the participants in the experimental group receiving 4 treatments over a 2-week period. Visual analogue scale (HAV-related pain), foot function index (HAV-related disability) and hallux dorsiflexion (goniometry). There were no participant dropouts and no data was missing. There were no statistical (pmanipulative therapy (experimental group) is equivalent to standard care of a night splint(s) (control group) for symptomatic mild to moderate HAV in the short term. The protocol of MMT maintains its treatment effect from 1-week to 1-month follow-up without further treatment, while patients receiving standard care seem to regress when not using the night splint. Insights from this study support further testing of MMT for symptomatic mild to moderate HAV, particularly where surgery

  3. Meta-analysis of randomized trials comparing fusion surgery to non-surgical treatment for discogenic chronic low back pain.

    Science.gov (United States)

    Wang, Xin; Wanyan, Pingping; Tian, Jin Hui; Hu, Long

    2015-01-01

    Chronic low back pain causes socioeconomic burdens. Whether lumbar fusion is more effective than nonsurgical treatment of discogenic low back pain (DLBP) is controversial. Several randomized controlled trials that compared conservative treatment and fusion surgery had conflicting conclusions. To compare between the effectiveness of lumbar fusion and nonsurgical intervention in patients with chronic low back pain caused by disc degeneration. PubMed, the Cochrane Library, EMBASE, the Science Citation Index, Chinese Biomedical Literature Database, and references of relevant papers published from 1990 to 2013 were searched. Related data matching standards established for this research were extracted and statistically analyzed by using the RevMan (5.2) software. Meta-analysis of 6 randomized controlled trials with a total of 889 patients revealed no difference in Oswestry Disability Index (ODI) score for DLBP between the fusion surgery and nonsurgical groups (mean difference, 1.94; 95% confidence interval [CI], -6.02 to 2.14). Postsurgical complication rate significantly differed between the 2 groups (risk ratio, 22.11; 95% CI, 55.99-81.60). Fusion surgery was not superior to nonsurgical treatment in terms of changes in ODI scores for DLBP. Fusion surgery resulted in surgical complications. Longer follow-up observation is necessary regarding condition-specific disability, pain, and life satisfaction.

  4. A review of randomized controlled trials comparing the effectiveness of hand held computers with paper methods for data collection

    Directory of Open Access Journals (Sweden)

    Heddle Nancy M

    2006-05-01

    Full Text Available Abstract Background Handheld computers are increasingly favoured over paper and pencil methods to capture data in clinical research. Methods This study systematically identified and reviewed randomized controlled trials (RCTs that compared the two methods for self-recording and reporting data, and where at least one of the following outcomes was assessed: data accuracy; timeliness of data capture; and adherence to protocols for data collection. Results A comprehensive key word search of NLM Gateway's database yielded 9 studies fitting the criteria for inclusion. Data extraction was performed and checked by two of the authors. None of the studies included all outcomes. The results overall, favor handheld computers over paper and pencil for data collection among study participants but the data are not uniform for the different outcomes. Handheld computers appear superior in timeliness of receipt and data handling (four of four studies and are preferred by most subjects (three of four studies. On the other hand, only one of the trials adequately compared adherence to instructions for recording and submission of data (handheld computers were superior, and comparisons of accuracy were inconsistent between five studies. Conclusion Handhelds are an effective alternative to paper and pencil modes of data collection; they are faster and were preferred by most users.

  5. Comparing the analgesic effect of heat patch containing iron chip and ibuprofen for primary dysmenorrhea: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Navvabi Rigi Shahindokht

    2012-08-01

    Full Text Available Abstract Background Primary dysmenorrhea is a common and sometimes disabling condition. In recent years, some studies aimed to improve the treatment of dysmenorrhea, and therefore, introduced several therapeutic measures. This study was designed to compare the analgesic effect of iron chip containing heat wrap with ibuprofen for the treatment of primary dysmenorrhea. Methods In this randomized (IRCT201107187038N2 controlled trial, 147 students (18–30 years old with the diagnosis of primary dysmenorrhea were enrolled considering the CONSORT guideline. Screening for primary dysmenorrhea was done by a two-question screening tool. The participants were randomly assigned into one of the intervention groups (heat Patch and ibuprofen. Data regarding the severity and emotional impact of the pain were recorded by a shortened version of McGill Pain Questionnaire (SF-MPQ. Student's t test was used for statistical analysis. Results The maximum and minimum pain severities were observed at 2 and 24 hours in both groups. The severity of sensual pain at 8, 12, and 24 hours was non-significantly less in the heat Patch group. There was also no significant difference between the groups regarding the emotional impact of pain at the first 2, 4, 8, 12 and 12 hours of menstruation. Conclusions Heat patch containing Iron chip has comparable analgesic effects to ibuprofen and can possibly be used for primary dysmenorrhea. Trial registration IRCT201107187038N2

  6. Pooled analysis of two randomized trials comparing titanium-nitride-oxide-coated stent versus drug-eluting stent in STEMI.

    Science.gov (United States)

    Tuomainen, Petri O; Sia, Jussi; Nammas, Wail; Niemelä, Matti; Airaksinen, Juhani K E; Biancari, Fausto; Karjalainen, Pasi P

    2014-07-01

    We performed a pooled analysis based on patient-level data from the TITAX-AMI and BASE-ACS trials to evaluate the outcome of titanium-nitride-oxide-coated bioactive stents vs drug-eluting stents in patients with ST-segment elevation myocardial infarction at 2-year follow-up. The TITAX-AMI trial compared bioactive stents with paclitaxel-eluting stents in 425 patients with acute myocardial infarction. The BASE-ACS trial compared bioactive stents with everolimus-eluting stents in 827 patients with acute coronary syndrome. The primary endpoint for the pooled analysis was major adverse cardiac events: a composite of cardiac death, recurrent myocardial infarction, or ischemia-driven target lesion revascularization at 2-year follow-up. The pooled analysis included 501 patients; 245 received bioactive stents, and 256 received drug-eluting stents. The pooled bioactive stent group was associated with a risk ratio of 0.85 for major adverse cardiac events (95% confidence interval, 0.53-1.35; P=.49) compared to the pooled drug-eluting stent group. Similarly, the pooled bioactive stent group was associated with a risk ratio of 0.71 for cardiac death (95% confidence interval, 0.26-1.95; P=.51), 0.44 for recurrent myocardial infarction (95% confidence interval, 0.20-0.97; P=.04), and 1.39 for ischemia-driven target lesion revascularization (95% confidence interval, 0.74-2.59; P=.30), compared to the pooled drug-eluting stent group. These results were confirmed by propensity-score adjusted analysis of the combined datasets. In patients with ST-segment elevation myocardial infarction, bioactive stents were associated with lower rates of recurrent myocardial infarction compared to drug-eluting stents at 2-year follow-up; yet, the rates of cardiac death and ischemia-driven target lesion revascularization were similar. Copyright © 2014 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

  7. A randomised trial comparing laparoscopy with laparotomy in the management of women with ruptured ectopic pregnancy

    Directory of Open Access Journals (Sweden)

    L Snyman

    2017-03-01

    Full Text Available Background. Ruptured ectopic pregnancy (REP is a common gynaecological emergency in resource-poor settings, where laparotomy is the standard treatment despite laparoscopic surgery being regarded as the optimal treatment. There is a lack of prospective randomised data comparing laparoscopic surgery with laparotomy in the surgical management of women with REP. Objective. To compare operative laparoscopy with laparotomy in women with REP. Methods. This was a randomised parallel study. One hundred and forty women with suspected REP were randomised to undergo operative laparoscopy or laparotomy. The outcome measures were operating time, hospital stay, pain scores and analgesic requirements, blood transfusion, time to return to work, and time to full recovery. Results. Operating time was significantly longer in the laparoscopy group (67.3 v. 30.5 minutes, p<0.001. Duration of hospital stay, pain scores and need for analgesia were significantly less in the laparoscopy group. Women in this group returned to work 8 days earlier and their time to full recovery was significantly shorter compared with those in the laparotomy group. Significantly more women undergoing laparotomy required blood transfusion than women in the laparoscopy group. In the latter group, 14.5% of women required blood transfusion compared with 26.5% in the laparotomy group (p=0.01. Conclusion. Operative laparoscopy in women treated for REP is feasible in a resource-poor setting and is associated with significantly less morbidity and a quicker return to economic activity.

  8. Comparing a stratified treatment strategy with the standard treatment in randomized clinical trials

    DEFF Research Database (Denmark)

    Sun, Hong; Bretz, Frank; Gerke, Oke

    2016-01-01

    idea of selecting the subset with minimal p-value when testing the subset-specific treatment effects. We present a framework to compare this approach with other approaches to select subsets by introducing three performance measures. The results of a comprehensive simulation study are presented...

  9. Mississippi Communities for Healthy Living: Results of a 6-Month Nutrition Education Comparative Effectiveness Trial

    Science.gov (United States)

    Landry, Alicia S.; Thomson, Jessica L.; Huye, Holly F.; Yadrick, Kathy; Connell, Carol L.

    2017-01-01

    Background: Improving the diet of communities experiencing health inequities can be challenging given that multiple dietary components are low in quality. Mississippi Communities for Healthy Living was designed to test the comparative effectiveness of nutrition education using a single- versus multiple-message approach to improve the diet of adult…

  10. Brief Cognitive Behavioural Therapy compared to optimised general practitioners’ care for depression : A randomised trial

    NARCIS (Netherlands)

    Schene, A.H.; Baas, K.D.; Koeter, M.W.J.; Lucassen, P.; Bockting, C.L.H.; Wittkampf, K.A.; Huyser, J.; van Weert, H.C.

    2014-01-01

    Background: How to treat Major Depressive Disorder (MDD) in primary care? Studies that compared (brief) Cognitive Behavioural Therapy (CBT) with care as usual by the General Practitioner (GP) found the first to be more effective. However, to make a fair comparison GP care should be optimised and

  11. Brief Cognitive Behavioural Therapy Compared to Optimised General Practitioners? Care for Depression: A Randomised Trial

    NARCIS (Netherlands)

    Schene, A. H.; Baas, K. D.; Koeter, M.; Lucassen, P.; Bockting, C. L. H.|info:eu-repo/dai/nl/258267992; Wittkampf, K. F.; van Weert, H. C.; Huyser, J.

    2014-01-01

    Background: How to treat Major Depressive Disorder (MDD) in primary care? Studies that compared (brief) Cognitive Behavioural Therapy (CBT) with care as usual by the General Practitioner (GP) found the first to be more effective. However, to make a fair comparison GP care should be optimised and

  12. Treatment of adenotonsillar hypertrophy: A prospective randomized trial comparing azithromycin vs. fluticasone

    Directory of Open Access Journals (Sweden)

    Seyed Mostafa Hashemi Jazi

    2011-01-01

    Conclusions: It could explain that though both of the improved and mentioned symptoms comparing within initial status, Azithromycin seems to be more effective than fluticasone in improving AH-related symptoms. Short term efficacy of the antibiotic is much significant than its long term effect.

  13. A randomized clinical trial comparing fitness and biofeedback training versus basic treatment in patients with fibromyalgia

    NARCIS (Netherlands)

    van Santen, Marijke; Bolwijn, Paulien; Verstappen, Frans; Bakker, Carla; Hidding, Alita; Houben, Harry; van der Heijde, Desiree; Landewé, Robert; van der Linden, Sjef

    2002-01-01

    To compare the therapeutic effects of physical fitness training or biofeedback training with the results of usual care in patients with fibromyalgia (FM). One hundred forty-three female patients with FM (American College of Rheumatology criteria) were randomized into 3 groups: a fitness program (n =

  14. Randomised controlled trial comparing two school furniture configurations in the printing performance of young children with cerebral palsy.

    Science.gov (United States)

    Ryan, Stephen E; Rigby, Patricia J; Campbell, Kent A

    2010-08-01

    This randomised controlled trial compared the same-session effects of two different school furniture configurations on printing legibility. A total of 30 school-age children with ambulatory cerebral palsy participated in this study. Each child provided one near-point printing sample of up to 34 letters while positioned on Mandal-type specialty school furniture and on standard school furniture. An assessor who was unaware of the intervention assignment scored printing errors. No significant difference in legibility score mean values between the interventions was detected and the effect size was small. Compared with standard school furniture, the use of specialty school furniture did not lead to immediate gains in printing legibility and other printing performance areas for children with cerebral palsy. Further study of the influence of functional abilities, other contextual factors and the longer-term use of school furniture on handwriting performance is recommended.

  15. A Comparative Clinical Trial of Topical Triamcinolone (Adcortyle and a Herbal Solution for the Treatment of Minor Aphthous Stomatitis

    Directory of Open Access Journals (Sweden)

    F Rad

    2010-10-01

    The aim of this study was to compare the therapeutic effect of topical Myrtus communis (myrtle solution with topical triamcinolone (Adcortyle in the treatment of minor apotheosis. Materials & Methods: This clinical-trial study was conducted at Kurdistan University of Medical Sciences in 2009. 100 patients were randomly assigned into 2 groups. The 1st group received topical myrtle solution. The 2nd group received topical trimcinolone (Adcortyle. After one week, patients' declaration about time of the recovery of the pain and deterioration of oral lesion was recorded. The gathered data was then analyzed using the SPSS statistical software using t-test and chi-square. Results: After treatment, both groups showed response to topical medications with no significant difference between them (p>0.05. Conclusion: results of this study showed that topical myrtle solution is effective in the treatment of minor aphthous stomatitis and its therapeutic effect is comparable with topical triamcinolone (Adcortyle.

  16. Postpartum perineal reapir performed by midwives: A randomised trial comparing two suture techniques for perineal repair leaving the skin unsutured

    DEFF Research Database (Denmark)

    Kindberg, Sara; Misan, Stehouwer; Hvidman, Lone

    2008-01-01

    healing, patient satisfaction, dyspareunia or need for resuturing. The continuous suture technique was significantly faster (15 min. vs. 17 min, p=0.03) and less suture material was used (1 vs. 2 packets, pleaving the skin unsutured...... appears to be equivalent to the continuous suture technique in relation to perineal pain, wound healing, patient satisfaction, dyspareunia and need for resuturing. The continuous technique, however, is faster and requires less suture material thus leaving it the more cost-effective of the two techniques......Postpartum perineal repair performed by midwives: A randomised trial comparing two suture techniques leaving the skin unsutured. Objective      To compare a continuous suture technique to interrupted stitches using inverted knots for postpartum perineal repair of second-degree lacerations...

  17. Comparative study of intrathecal hyperbaric versus isobaric ropivacaine: A randomized control trial

    Directory of Open Access Journals (Sweden)

    Rajni Gupta

    2013-01-01

    Full Text Available Background: Hyperbaric ropivacaine produce more reliable sensory and motor block, with faster onset, better quality of muscles relaxation than isobaric ropivacaine. So, this study was designed to compare the efficacy of hyperbaric ropivacaine with isobaric ropivacaine in patients undergoing lower abdominal surgery. Methods: A randomized controlled double blind study in two groups of patients. group A (n=35 received 3 ml of isobaric ropivacaine 6 mg/ml (18 mg. Group B (n=35 received 3 ml of hyperbaric ropivacaine 6 mg/ml (18 mg. The onset and duration of sensory block at dermatome level T10, maximum upper and lower spread of sensory block, intensity, and duration of motor block were recorded. Statistical Analysis: Block characteristics were compared using the two-tailed Mann - Whitney U-test. The proportion of side effects was compared using the Chi-square test. Results: The median time of onset of sensory block at the T10 dermatome was 4.4±1.3 min in group B and 6.0±1.03 min in group A. The median time to maximum block height was 16.7±3.7 min in group A and 12.03±1.96 min in group B. The median duration of complete motor recovery (B0 was significantly shorter in the heavy ropivacaine group (166.5±11.7 min compared with the isobaric ropivacaine group (192.9±9.6 min. Conclusions: Intrathecal hyperbaric ropivacaine provides more rapid, adequate, and good quality of sensory and motor block with rapid post-operative recovery as compare to isobaric ropivacaine.

  18. Randomized clinical trial comparing 2 support surfaces: results of the Prevention of Pressure Ulcers Study.

    Science.gov (United States)

    Russell, Linda J; Reynolds, Tim M; Park, Carol; Rithalia, Shyam; Gonsalkorale, M; Birch, Jan; Torgerson, David; Iglesias, Cynthia

    2003-11-01

    To determine whether a viscoelastic polymer (energy absorbing) foam mattress was superior to a standard hospital mattress for pressure ulcer prevention and to analyze the cost-effectiveness in comparison with standard hospital mattresses. Unblinded, randomized, prospective trial. Elderly acute care, rehabilitation, and orthopedic wards at 3 hospitals in the United Kingdom. 1168 patients at risk of developing pressure ulcers (Waterlow score, 15 to 20), with a median age of 83 years (25th to 75th percentile range, 79-87). Participants were allocated to either the experimental equipment (CONFOR-Med mattress/cushion combination) or a standard mattress/cushion combination; all were given standard nursing care. Pressure areas were observed daily. Development of nonblanching erythema. A significant decrease in the incidence of blanching erythema (26.3% to 19.9%; P =.004) and a nonsignificant decrease in the incidence of nonblanching erythema occurred in participants allocated to the experimental equipment. However, when the survival curve plots were analyzed at 7 days, both categories showed statistically significant decreases (P =.0015 and P =.042, respectively). Participants on standard equipment had a relative odds ratio of 1.36 (95% confidence interval [CI], 1.10-1.69) for developing blanching erythema or worse and 1.46 (95% CI, 0.90-1.82) for developing nonblanching erythema or worse. To prevent nonblanching erythema, the number needed to treat (NNT) was 41.9 (95% CI, -82.6-15.3). To prevent any erythema (blanching or nonblanching), the NNT was 11.5 (95% CI, 41.6-9.3). Participants with blanching or nonblanching erythema were significantly less mobile than participants with normal skin and more likely to have worsening mobility (P pressure ulcer status, mattress type was not associated with difference in mobility. Regardless of prevention routine, pressure ulcers occur. In this study, the experimental equipment showed statistical significance to standard equipment

  19. More complications in uncemented compared to cemented hemiarthroplasty for displaced femoral neck fractures: a randomized controlled trial of 201 patients, with one year follow-up

    NARCIS (Netherlands)

    S. Moerman (Sophie); N.M.C. Mathijssen (Nina M.C.); D.D. Niesten (Dieu-Donné); R. Riedijk (Roeland); W.J. Rijnberg (Willard); S. Koëter (Sander); K. Kremers van de Hei (Keetie); W.E. Tuinebreijer (Wim); T.L. Molenaar (Tim L.); R.G.H.H. Nelissen (Rob); A.J.H. Vochteloo (Anne)

    2017-01-01

    textabstractBackground: It is unclear whether cemented or uncemented hemiarthroplasty is the best treatment option in elderly patients with displaced femoral neck fractures. Previous randomized trials comparing cemented and uncemented hemiarthroplasty have conflicting results. We conducted a

  20. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial.

    NARCIS (Netherlands)

    Ederle, J.; Dobson, J.; Featherstone, R.L.; Bonati, L.H.; Worp, H.B. van der; Borst, G.J. de; Lo, T.H.; Gaines, P.; Dorman, P.J.; Macdonald, S.; Lyrer, P.A.; Hendriks, J.M.; McCollum, C.; Nederkoorn, P.J.; Brown, M.M.; Blankensteijn, J.D.; Leeuw, F.E. de; Schultze Kool, L.J.; Vliet, J.A. van der; et al.,

    2010-01-01

    BACKGROUND: Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy. METHODS: The International

  1. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial

    NARCIS (Netherlands)

    Ederle, Jörg; Dobson, Joanna; Featherstone, Roland L.; Bonati, Leo H.; van der Worp, H. Bart; de Borst, Gert J.; Lo, T. Hauw; Gaines, Peter; Dorman, Paul J.; Macdonald, Sumaira; Lyrer, Philippe A.; Hendriks, Johanna M.; McCollum, Charles; Nederkoorn, Paul J.; Brown, Martin M.; Algra, A.; Bamford, J.; Beard, J.; Bland, M.; Bradbury, A. W.; Brown, M. M.; Clifton, A.; Gaines, P.; Collins, R.; Molyneux, A.; Naylor, R.; Warlow, C.; Ferro, J. M.; Thomas, D.; Bonati, L. H.; Coward, L.; Dobson, J.; Ederle, J.; Featherstone, R. F.; Tindall, H.; McCabe, D. J. H.; Wallis, A.; Brooks, M.; Chambers, B.; Chan, A.; Chu, P.; Clark, D.; Dewey, H.; Donnan, G.; Fell, G.; Hoare, M.; Molan, M.; Roberts, A.; Roberts, N.; Beiles, B.; Bladin, C.; Clifford, C.; Grigg, M.; New, G.; Bell, R.; Bower, S.; Chong, W.; Holt, M.; Saunder, A.; Than, P. G.; Gett, S.; Leggett, D.; McGahan, T.; Quinn, J.; Ray, M.; Wong, A.; Woodruff, P.; Foreman, R.; Schultz, D.; Scroop, R.; Stanley, B.; Allard, B.; Atkinson, N.; Cambell, W.; Davies, S.; Field, P.; Milne, P.; Mitchell, P.; Tress, B.; Yan, B.; Beasley, A.; Dunbabin, D.; Stary, D.; Walker, S.; Cras, P.; d'Archambeau, O.; Hendriks, J. M. H.; van Schil, P.; St Blasius, A. Z.; Bosiers, M.; Deloose, K.; van Buggenhout, E.; de Letter, J.; Devos, V.; Ghekiere, J.; Vanhooren, G.; Astarci, P.; Hammer, F.; Lacroix, V.; Peeters, A.; Verbist, J.; Blair, J.-F.; Caron, J. L.; Daneault, N.; Giroux, M.-F.; Guilbert, F.; Lanthier, S.; Lebrun, L.-H.; Oliva, V.; Raymond, J.; Roy, D.; Soulez, G.; Weill, A.; Hill, M.; Hu, W.; Hudion, M.; Morrish, W.; Sutherland, G.; Wong, J.; Albäck, A.; Harno, H.; Ijäs, P.; Kaste, M.; Lepäntalo, M.; Mustanoja, S.; Paananen, T.; Porras, M.; Putaala, J.; Railo, M.; Sairanen, T.; Soinne, L.; Vehmas, A.; Vikatmaa, P.; Goertler, M.; Halloul, Z.; Skalej, M.; Brennan, P.; Kelly, C.; Leahy, A.; Moroney, J.; Thornton, J.; Koelemay, M. J. W.; Reekers, J. A. A.; Roos, Y. B. W. E. M.; Hendriks, J. M.; Koudstaal, P. J.; Pattynama, P. M. T.; van der Lugt, A.; van Dijk, L. C.; van Sambeek, M. R. H. M.; van Urk, H.; Verhagen, H. J. M.; Bruijninckx, C. M. A.; de Bruijn, S. F.; Keunen, R.; Knippenberg, B.; Mosch, A.; Treurniet, F.; van Dijk, L.; van Overhagen, H.; Wever, J.; de Beer, F. C.; van den Berg, J. S. P.; van Hasselt, B. A. A. M.; Zeilstra, D. J.; Boiten, J.; van Otterloo, J. C. A. de Mol; de Vries, A. C.; Lycklama a Nijeholt, G. J.; van der Kallen, B. F. W.; Blankensteijn, J. D.; de Leeuw, F. E.; Kool, L. J. Schultze; van der Vliet, J. A.; de Borst, G. J.; de Kort, G. A. P.; Kapelle, L. J.; Lo, T. H.; Mali, W. P. Th M.; Moll, F.; van der Worp, H. B.; Verhagen, H.; Barber, P. A.; Bourchier, R.; Hill, A.; Holden, A.; Stewart, J.; Bakke, S. J.; Krohg-Sørensen, K.; Skjelland, M.; Tennøe, B.; Bialek, P.; Biejat, Z.; Czepiel, W.; Czlonkowska, A.; Dowzenko, A.; Jedrzejewska, J.; Kobayashi, A.; Lelek, M.; Polanski, J.; Kirbis, J.; Milosevic, Z.; Zvan, B.; Blasco, J.; Chamorro, A.; Macho, J.; Obach, V.; Riambau, V.; San Roman, L.; Branera, J.; Canovas, D.; Estela, Jordi; Gaibar, A. Gimenez; Perendreu, J.; Björses, K.; Gottsater, A.; Ivancev, K.; Maetzsch, T.; Sonesson, B.; Berg, B.; Delle, M.; Formgren, J.; Gillgren, P.; Kall, T.-B.; Konrad, P.; Nyman, N.; Takolander, R.; Andersson, T.; Malmstedt, J.; Soderman, M.; Wahlgren, C.; Wahlgren, N.; Binaghi, S.; Hirt, L.; Michel, P.; Ruchat, P.; Engelter, S. T.; Fluri, F.; Guerke, L.; Jacob, A. L.; Kirsch, E.; Lyrer, P. A.; Radue, E.-W.; Stierli, P.; Wasner, M.; Wetzel, S.; Bonvin, C.; Kalangos, A.; Lovblad, K.; Murith, M.; Ruefenacht, D.; Sztajzel, R.; Higgins, N.; Kirkpatrick, P. J.; Martin, P.; Varty, K.; Adam, D.; Bell, J.; Crowe, P.; Gannon, M.; Henderson, M. J.; Sandler, D.; Shinton, R. A.; Scriven, J. M.; Wilmink, T.; D'Souza, S.; Egun, A.; Guta, R.; Punekar, S.; Seriki, D. M.; Thomson, G.; Brennan, J. A.; Enevoldson, T. P.; Gilling-Smith, G.; Gould, D. A.; Harris, P. L.; McWilliams, R. G.; Nasser, H.-C.; White, R.; Prakash, K. G.; Serracino-Inglott, F.; Subramanian, G.; Symth, J. V.; Walker, M. G.; Clarke, M.; Davis, M.; Dixit, S. A.; Dorman, P.; Dyker, A.; Ford, G.; Golkar, A.; Jackson, R.; Jayakrishnan, V.; Lambert, D.; Lees, T.; Louw, S.; Macdonald, S.; Mendelow, A. D.; Rodgers, H.; Rose, J.; Stansby, G.; Wyatt, M.; Baker, T.; Baldwin, N.; Jones, L.; Mitchell, D.; Munro, E.; Thornton, M.; Baker, D.; Davis, N.; Hamilton, G.; McCabe, D.; Platts, A.; Tibballs, J.; Cleveland, T.; Dodd, D.; Lonsdale, R.; Nair, R.; Nassef, A.; Nawaz, S.; Venables, G.; Belli, A.; Cloud, G.; Halliday, A.; Markus, H.; McFarland, R.; Morgan, R.; Pereira, A.; Thompson, A.; Chataway, J.; Cheshire, N.; Gibbs, R.; Hammady, M.; Jenkins, M.; Malik, I.; Wolfe, J.; Adiseshiah, M.; Bishop, C.; Brew, S.; Brookes, J.; Jäger, R.; Kitchen, N.; Ashleigh, R.; Butterfield, S.; Gamble, G. E.; McCollum, C.; Nasim, A.; O'Neill, P.; Edwards, R. D.; Lees, K. R.; MacKay, A. J.; Moss, J.

    2010-01-01

    BACKGROUND: Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy. METHODS: The International

  2. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study) : an interim analysis of a randomised controlled trial

    NARCIS (Netherlands)

    Ederle, Joerg; Dobson, Joanna; Featherstone, Roland L.; Bonati, Leo H.; van der Worp, H. Bart; de Borst, Gert J.; Lo, T. Hauw; Gaines, Peter; Dorman, Paul J.; Macdonald, Sumaira; Lyrer, Philippe A.; Hendriks, Johanna M.; McCollum, Charles; Nederkoorn, Paul J.; Brown, Martin M.; Algra, A.; Bamford, J.; Beard, J.; Bland, M.; Bradbury, A. W.; Brown, M. M.; Clifton, A.; Gaines, P.; Hacke, W.; Halliday, A.; Malik, I.; Mas, J. L.; McGuire, A. J.; Sidhu, P.; Venables, G.; Bradbury, A.; Brown, M. M.; Clifton, A.; Gaines, P.; Collins, R.; Molynewc, A.; Naylor, R.; Warlow, C.; Ferro, J. M.; Thomas, D.; Bonati, L. H.; Coward, L.; Dobson, J.; Ederle, J.; Featherstone, R. F.; Tindall, H.; McCabe, D. J. H.; Wallis, A.; Hendriks, J. M. H.; Hendriks, J. M.

    2010-01-01

    Background Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy. Methods The International Carotid

  3. Comparative efficacy and safety of anticoagulant strategies for acute coronary syndromes. Comprehensive network meta-analysis of 42 randomised trials involving 117,353 patients

    NARCIS (Netherlands)

    Navarese, Eliano Pio; Andreotti, Felicita; Kołodziejczak, Michalina; Schulze, Volker; Wolff, Georg; Dias, Sofia; Claessen, Bimmer; Brouwer, Marc; Tarantini, Giuseppe; Iliceto, Sabino; Brockmeyer, Maximilian; Kowalewski, Mariusz; Lin, Yingfeng; Eikelboom, John; Musumeci, Giuseppe; Lee, Leong; Lip, Gregory Y. H.; Valgimigli, Marco; Berti, Sergio; Kelm, Malte

    2015-01-01

    International guidelines differ in strengths of recommendation for anticoagulation strategies in acute coronary syndromes (ACS). We performed a comprehensive network meta-analysis (NMA) of randomised controlled trials (RCTs) to investigate the comparative efficacy and safety of parenteral

  4. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial.

    LENUS (Irish Health Repository)

    Ederle, Jörg

    2010-03-20

    Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy.

  5. Analysis of complications in a prospective randomized trial comparing two brachytherapy low dose rates in cervical carcinoma

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1994-07-30

    The analysis of complications in a prospective randomized trial comparing two preoperative brachytherapy low-dose rates in early stage cervical cancer is presented. The objective of this trial was to determine the benefits, if any, of the higher-dose rate within the therapeutic aresenal for this patient population, in terms of survival, local control, and complications. Overall survival, 85% at 2 years and local control, 93% at 2 years, were similarly distributed between the two groups. Regardless of their nature and severity, 139 and 175 complications were observed among 63% and 75% of patients, in the 0.4 and 0.8 Gy/h dose rate groups respectively. Gynecologic and urinary complications were the most frequent (38% and 28% of all complications), followed by vascular (15%), digestive (10%), nervous (5%), and cutaneous (5%). A total of 14 and 17 severe complications (Grade 3) were observed in 7% and 13% of patients, respectively in the 0.4 and 0.8 Gy/h dose rate groups (p = 0.12) Nonparametric survival methods used to compare the time to the first complication did not show a significant difference between the two groups: 62% and 72% at 2 years (p = 0.27). When the first complication and its evolution were considered (early complications), the prevalence of complications was not significantly different between the two groups: 28% vs. 34% at 2 years (p = 0.31). In this prospective trial, patients were regularly followed-up and complications of varying nature and severity were observed in succession during follow-up. When successive complications and their evolution were taken into account, the prevalence of complications was significantly greater in the higher-dose rate group: 30% vs 45% at 2 years (p = 0.03). The results of this trial showed that long-term effects of treatment, when represented by prevalence of complications over time, were more frequent in the higher dose rate group. 33 refs., 3 figs., 5 tabs.

  6. Improvdent: Improving dentures for patient benefit. A crossover randomised clinical trial comparing impression materials for complete dentures

    Directory of Open Access Journals (Sweden)

    Gray Janine C

    2012-08-01

    Full Text Available Abstract Background According to the UK Adult Dental Health Survey (2009 15% of adults aged 65–74, 30% aged 75–84 and 47% aged >85 years are edentulous and require complete dentures. Patients’ quality of life and nutrition status are affected by poor dentures. The quality of the dental impression is the most important issue for improving the fit and comfort of new dentures. There is paucity of RCT evidence for which impression material is best for complete dentures construction. This study aims to compare two impression materials for effectiveness and cost effectiveness. Methods/Design IMPROVDENT is a double-blind crossover trial comparing the use of alginate and silicone, two commonly used denture impression materials, in terms of patient preference and cost-effectiveness. Eighty five edentulous patients will be recruited and provided with two sets of dentures, similar in all aspects except for the impression material used (alginate or silicone. Patients will try both sets of dentures for a two-week period, unadjusted, to become accustomed to the feel of the new dentures (habituation period. Patients will then wear each set of dentures for a period of 8 weeks (in random order during which time the dentures will be adjusted for optimum comfort. Finally, patients will be given both sets of dentures for a further two weeks to wear whichever denture they prefer (confirmation period. Patients will be asked about quality of life and to rate dentures on function and comfort at the end of each trial period and asked which set they prefer at the end of the habituation period (unadjusted denture preference and confirmation period (adjusted denture preference. A health economic evaluation will estimate incremental cost-effectiveness ratios of producing dentures from the two materials. A qualitative study will investigate the impact of dentures on behaviour and quality of life. Funding: IMPROVDENT is funded by NIHR RfPB (PB-PG-0408-16300. Discussion

  7. Comparative effectiveness of post-discharge interventions for hospitalized smokers: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Japuntich Sandra J

    2012-08-01

    Full Text Available Abstract Background A hospital admission offers smokers an opportunity to quit. Smoking cessation counseling provided in the hospital is effective, but only if it continues for more than one month after discharge. Providing smoking cessation medication at discharge may add benefit to counseling. A major barrier to translating this research into clinical practice is sustaining treatment during the transition to outpatient care. An evidence-based, practical, cost-effective model that facilitates the continuation of tobacco treatment after discharge is needed. This paper describes the design of a comparative effectiveness trial testing a hospital-initiated intervention against standard care. Methods/design A two-arm randomized controlled trial compares the effectiveness of standard post-discharge care with a multi-component smoking cessation intervention provided for three months after discharge. Current smokers admitted to Massachusetts General Hospital who receive bedside smoking cessation counseling, intend to quit after discharge and are willing to consider smoking cessation medication are eligible. Study participants are recruited following the hospital counseling visit and randomly assigned to receive Standard Care or Extended Care after hospital discharge. Standard Care includes a recommendation for a smoking cessation medication and information about community resources. Extended Care includes up to three months of free FDA-approved smoking cessation medication and five proactive computerized telephone calls that use interactive voice response technology to provide tailored motivational messages, offer additional live telephone counseling calls from a smoking cessation counselor, and facilitate medication refills. Outcomes are assessed at one, three, and six months after hospital discharge. The primary outcomes are self-reported and validated seven-day point prevalence tobacco abstinence at six months. Other outcomes include short-term and

  8. Comparative clinical trial of castor oil and diclofenac sodium in patients with osteoarthritis.

    Science.gov (United States)

    Medhi, B; Kishore, K; Singh, U; Seth, S D

    2009-10-01

    A randomized, double-blind, comparative clinical study was conducted to compare the safety and efficacy of castor oil with diclofenac sodium in patients with knee osteoarthritis. Subjects with symptoms of knee osteoarthritis were given a castor oil capsule 0.9 mL (n = 50) thrice daily for 4 weeks or a capsule of diclofenac sodium (n = 50), 50 mg thrice daily for 4 weeks. The subjects completed an overall evaluation of symptom relief at 2 weeks and 4 weeks of completed treatment. The subjects were evaluated by clinical, routine laboratory and radiographic investigations for improvement of disease conditions and also for adverse drug reaction. On completion of 4 weeks treatment it was observed that both drugs were significantly effective in the treatment of knee osteoarthritis (p castor oil there were no adverse effects reported. The present study indicates that castor oil can be used as an effective therapy in primary knee osteoarthritis. (c) 2009 John Wiley & Sons, Ltd.

  9. A randomised trial comparing the antibacterial effects of dentine primers against bacteria in natural root caries.

    Science.gov (United States)

    Rolland, S L; McCabe, J F; Imazato, S; Walls, A W G

    2011-01-01

    As people are living longer and retaining their teeth into old age, root caries is an increasingly significant problem. A minimally invasive treatment strategy, involving sealing the root caries lesion with an antibacterial resin sealant, could be highly beneficial. The aim of this study was to compare the antibacterial properties of the primers of two proprietary dentine bonding agents, Clearfil SE Bond (SE; Kuraray Medical, Japan) and Clearfil Protect Bond (PB; Kuraray Medical), which contains the antibacterial monomer methacryloyloxydodecylpyridinium bromide. Fifty-two root caries lesions were identified and randomly assigned to a primer. The lesion was cleaned, isolated, sampled with a sharp spoon excavator, a primer applied and a second sample taken. Samples were transported in fastidious anaerobe broth, vortex-dispersed and serial dilutions inoculated onto selective agars. Reduction in colony-forming units (CFU, %) after primer application was calculated for both primers for bacterial growth on each selective agar and compared to a hypothesised mean of 100% (one-sample t test, p < 0.05). No significant differences between primers were seen, indicating efficient bacterial elimination by both materials. Comparing percent reduction between SE and PB for each agar (Mann-Whitney test, p < 0.05), a significantly greater CFU reduction by PB was seen for streptococci but not other bacteria. More lesions exhibited bacterial growth and several lesions demonstrated marked bacterial growth after treatment with SE compared with PB. Therefore, PB appears to exhibit superior antimicrobial properties, particularly against streptococci. Both primers are highly antibacterial towards root caries bacteria and may therefore be suitable for minimally invasive treatment. Copyright © 2011 S. Karger AG, Basel.

  10. Comparative efficacy of two daily use mouthrinses: randomized clinical trial using an experimental gingivitis model

    OpenAIRE

    Charles, Christine Ann; McGuire, James Anthony; Sharma, Naresh Chandra; Qaqish, James

    2011-01-01

    Two antimicrobial agents, a fixed combination of essential oils (EOs) and 0.07% cetylpyridinium chloride (CPC) are found in commercially available mouthrinses, Listerine® Antiseptic and Crest® Pro HealthTM, respectively. Both mouthrinses have been shown to control dental plaque and gingivitis in short and longer term studies. The aim of this study was to determine the comparative effectiveness of these two mouthrinses using a 2-week experimental gingivitis model. Qualified subjects were rando...

  11. COMPAR

    International Nuclear Information System (INIS)

    Kuefner, K.

    1976-01-01

    COMPAR works on FORTRAN arrays with four indices: A = A(i,j,k,l) where, for each fixed k 0 ,l 0 , only the 'plane' [A(i,j,k 0 ,l 0 ), i = 1, isub(max), j = 1, jsub(max)] is held in fast memory. Given two arrays A, B of this type COMPAR has the capability to 1) re-norm A and B ind different ways; 2) calculate the deviations epsilon defined as epsilon(i,j,k,l): =[A(i,j,k,l) - B(i,j,k,l)] / GEW(i,j,k,l) where GEW (i,j,k,l) may be chosen in three different ways; 3) calculate mean, standard deviation and maximum in the array epsilon (by several intermediate stages); 4) determine traverses in the array epsilon; 5) plot these traverses by a printer; 6) simplify plots of these traverses by the PLOTEASY-system by creating input data blocks for this system. The main application of COMPAR is given (so far) by the comparison of two- and three-dimensional multigroup neutron flux-fields. (orig.) [de

  12. Open Clinical Trial on Using Nifuroxazide Compared to Probiotics in Treating Acute Diarrhoeas in Adults.

    Science.gov (United States)

    Begovic, Begler; Ahmedtagic, Sead; Calkic, Lejla; Vehabović, Midhat; Kovacevic, Sanela Bakić; Catic, Tarik; Mehic, Meliha

    2016-12-01

    Nifuroxazide is well known and often used anti-diarrhoeal medicine which has been pushed back from routine practice in recent years and often replaced with probiotics. Even probiotics are accepted and placed in some therapeutic guidelines for diarrhoea treatment, there are no enough evidence for its effectiveness and no comparative efficacy data with nifuroxazide in treatment of acute diarrhea. In open, prospective observational study, the efficacy and safety of nifuroxazide were compared with a probiotic containing lactic acid bacteria in the treatment of acute diarrhoea. A total number of 169 adult patients were included in this study, who administered nifuroxazide in the dose of 200 mg/4 times a day, while they took preparation containing lactic acid bacteria (1,2 x 10 7 live lyophilised lactic-acid bacteria) three times a day for three days. Mean time to last unformed stool (TLUS) in a group which was treated with nifuroxazide was two days, while it took five days for the stool normalisation in the group using probiotic (p=0.0001). Orally administered nifuroxazide has demonstrated better efficiency as compared to probiotic in treating acute diarrhoea, and both medicines have shown the same safety and tolerance in this study.

  13. Standard compared with mnemonic counseling for fecal incontinence: a randomized controlled trial.

    Science.gov (United States)

    Cichowski, Sara B; Dunivan, Gena C; Rogers, Rebecca G; Murrietta, Ambroshia M; Komesu, Yuko M

    2015-05-01

    To estimate whether women who underwent mnemonic counseling had better recall of fecal incontinence therapies at 2 months and if mnemonic counseling resulted in greater satisfaction with physician counseling and improvement in quality of life when compared with a group who underwent standard counseling. Counseling-naive women with fecal incontinence were recruited from an academic urogynecology clinic. Women underwent physical examinations, completed the Quality of the Physician-Patient Interaction, recorded fecal incontinence treatment options they recalled, and completed the Fecal Incontinence Severity Index and Manchester Health Questionnaire immediately after counseling and again at 2 months. Ninety women consented to participate, were randomized, and completed baseline questionnaires. At baseline, women did not differ in age, ethnicity, education, Fecal Incontinence Severity Index, or Manchester Health Questionnaire scores. After counseling, the mnemonic group reported higher satisfaction on Quality of the Physician-Patient Interaction (66.4±6.5 compared with 62.2±10.7, P=.03). Ninety percent (81/90) of women followed up at 2 months. Our primary endpoint, 2-month recall of fecal incontinence treatments, was not different between groups (2.3±1.6 mnemonic counseling compared with 1.8±1.0 standard counseling; P=.08). Secondary endpoints for the mnemonic group reported greater improvement on total Manchester Health Questionnaire (P=.02), emotional (P=.03), sleep (0.045), role limitations (Pmnemonic aid did not improve recall at 2 months but improved patient satisfaction and quality of life at 2 months.

  14. Comparative efficacy of two daily use mouthrinses: randomized clinical trial using an experimental gingivitis model

    Directory of Open Access Journals (Sweden)

    Christine Ann Charles

    2011-08-01

    Full Text Available Two antimicrobial agents, a fixed combination of essential oils (EOs and 0.07% cetylpyridinium chloride (CPC are found in commercially available mouthrinses, Listerine® Antiseptic and Crest® Pro HealthTM, respectively. Both mouthrinses have been shown to control dental plaque and gingivitis in short and longer term studies. The aim of this study was to determine the comparative effectiveness of these two mouthrinses using a 2-week experimental gingivitis model. Qualified subjects were randomly assigned to one of three mouthrinse groups: a fixed combination of EOs, 0.07% CPC, or negative control (C rinse. Following baseline clinical assessments and a dental prophylaxis, subjects began a two-week period in which they rinsed twice daily with their assigned rinse and abstained from any mechanical oral hygiene procedures or other oral care products. Subjects were reassessed at the end of the two-week period. One hundred and forty-seven subjects were randomized and 142 completed this study. After two weeks use, the EOs rinse was superior (p < 0.011 to the CPC rinse in inhibiting the development of gingivitis, plaque, and bleeding, with 9.4% and 6.6% reductions compared to CPC for gingivitis and plaque, respectively. Both rinses were superior to the negative control rinse (p < 0.001. This study demonstrates that the essential oil-containing mouthrinse has superior antiplaque/antigingivitis effectiveness compared to the 0.07% CPC-containing mouthrinse without mechanical oral hygiene influence.

  15. Scientific writing: a randomized controlled trial comparing standard and on-line instruction.

    Science.gov (United States)

    Phadtare, Amruta; Bahmani, Anu; Shah, Anand; Pietrobon, Ricardo

    2009-05-27

    Writing plays a central role in the communication of scientific ideas and is therefore a key aspect in researcher education, ultimately determining the success and long-term sustainability of their careers. Despite the growing popularity of e-learning, we are not aware of any existing study comparing on-line vs. traditional classroom-based methods for teaching scientific writing. Forty eight participants from a medical, nursing and physiotherapy background from US and Brazil were randomly assigned to two groups (n = 24 per group): An on-line writing workshop group (on-line group), in which participants used virtual communication, google docs and standard writing templates, and a standard writing guidance training (standard group) where participants received standard instruction without the aid of virtual communication and writing templates. Two outcomes, manuscript quality was assessed using the scores obtained in Six subgroup analysis scale as the primary outcome measure, and satisfaction scores with Likert scale were evaluated. To control for observer variability, inter-observer reliability was assessed using Fleiss's kappa. A post-hoc analysis comparing rates of communication between mentors and participants was performed. Nonparametric tests were used to assess intervention efficacy. Excellent inter-observer reliability among three reviewers was found, with an Intraclass Correlation Coefficient (ICC) agreement = 0.931882 and ICC consistency = 0.932485. On-line group had better overall manuscript quality (p = 0.0017, SSQSavg score 75.3 +/- 14.21, ranging from 37 to 94) compared to the standard group (47.27 +/- 14.64, ranging from 20 to 72). Participant satisfaction was higher in the on-line group (4.3 +/- 0.73) compared to the standard group (3.09 +/- 1.11) (p = 0.001). The standard group also had fewer communication events compared to the on-line group (0.91 +/- 0.81 vs. 2.05 +/- 1.23; p = 0.0219). Our protocol for on-line scientific writing instruction is

  16. Cellular versus acellular matrix devices in treatment of diabetic foot ulcers: study protocol for a comparative efficacy randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Lev-Tov Hadar

    2013-01-01

    Full Text Available Abstract Background Diabetic foot ulcers (DFUs represent a significant source of morbidity and an enormous financial burden. Standard care for DFUs involves systemic glucose control, ensuring adequate perfusion, debridement of nonviable tissue, off-loading, control of infection, local wound care and patient education, all administered by a multidisciplinary team. Unfortunately, even with the best standard of care (SOC available, only 24% or 30% of DFUs will heal at weeks 12 or 20, respectively. The extracellular matrix (ECM in DFUs is abnormal and its impairment has been proposed as a key target for new therapeutic devices. These devices intend to replace the aberrant ECM by implanting a matrix, either devoid of cells or enhanced with fibroblasts, keratinocytes or both as well as various growth factors. These new bioengineered skin substitutes are proposed to encourage angiogenesis and in-growth of new tissue, and to utilize living cells to generate cytokines needed for wound repair. To date, the efficacy of bioengineered ECM containing live cellular elements for improving healing above that of a SOC control group has not been compared with the efficacy of an ECM devoid of cells relative to the same SOC. Our hypothesis is that there is no difference in the improved healing effected by either of these two product types relative to SOC. Methods/Design To test this hypothesis we propose a randomized, single-blind, clinical trial with three arms: SOC, SOC plus Dermagraft® (bioengineered ECM containing living fibroblasts and SOC plus Oasis® (ECM devoid of living cells in patients with nonhealing DFUs. The primary outcome is the percentage of subjects that achieved complete wound closure by week 12. Discussion If our hypothesis is correct, then immense cost savings could be realized by using the orders-of-magnitude less expensive acellular ECM device without compromising patient health outcomes. The article describes the protocol proposed to test

  17. A virtual clinical trial comparing static versus dynamic PET imaging in measuring response to breast cancer therapy

    Science.gov (United States)

    Wangerin, Kristen A.; Muzi, Mark; Peterson, Lanell M.; Linden, Hannah M.; Novakova, Alena; Mankoff, David A.; E Kinahan, Paul

    2017-05-01

    We developed a method to evaluate variations in the PET imaging process in order to characterize the relative ability of static and dynamic metrics to measure breast cancer response to therapy in a clinical trial setting. We performed a virtual clinical trial by generating 540 independent and identically distributed PET imaging study realizations for each of 22 original dynamic fluorodeoxyglucose (18F-FDG) breast cancer patient studies pre- and post-therapy. Each noise realization accounted for known sources of uncertainty in the imaging process, such as biological variability and SUV uptake time. Four definitions of SUV were analyzed, which were SUVmax, SUVmean, SUVpeak, and SUV50%. We performed a ROC analysis on the resulting SUV and kinetic parameter uncertainty distributions to assess the impact of the variability on the measurement capabilities of each metric. The kinetic macro parameter, K i , showed more variability than SUV (mean CV K i   =  17%, SUV  =  13%), but K i pre- and post-therapy distributions also showed increased separation compared to the SUV pre- and post-therapy distributions (mean normalized difference K i   =  0.54, SUV  =  0.27). For the patients who did not show perfect separation between the pre- and post-therapy parameter uncertainty distributions (ROC AUC  therapy, ranging from 12 to 14 of 16 patients over all SUV definitions and uptake time scenarios (p  therapy. This methodology can be applied to different scenarios with the ability to inform the design of clinical trials using PET imaging.

  18. The Comparative Safety of TNF Inhibitors in Ankylosing Spondylitis-a Meta-Analysis Update of 14 Randomized Controlled Trials.

    Science.gov (United States)

    Hou, Li-Qiong; Jiang, Ga-Xue; Chen, Yan-Fei; Yang, Xi-Mei; Meng, Lei; Xue, Miao; Liu, Xiao-Guang; Chen, Xi-Chao; Li, Xiao

    2017-07-17

    TNF inhibitors have been used in ankylosing spondylitis (AS). The efficacy of TNF inhibitors was already evaluated by meta-analysis of randomized controlled trials (RCTs). However, the safety of TNF inhibitors is still unclear. Therefore, we aimed to evaluate and update the safety data from RCTs of TNF inhibitors in patients treated for AS. A systematic literature search was conducted from 1990 through May 31, 2016. All studies included were randomized, double-blind, controlled trials of patients with ankylosing spondylitis that evaluated adalimumab, certolizumab pegol, etanercept, golimumab, or infliximab treatment. The overall serious adverse events, the risk of serious infection events, and the risk of malignancy and discontinuation rates were abstracted, and risk estimates were calculated by Peto odds ratios (ORs). Fourteen randomized controlled trials involving 2032 subjects receiving TNF inhibitors and 1030 subjects receiving placebo and/or traditional disease-modifying anti-rheumatic drugs (DMARDs) were included. The overall serious adverse events (OR, 1.34; 95% CI, 0.87-2.05), the risk of serious infection events (OR, 1.59; 95% CI, 0.63-4.01), the risk of malignancy (OR, 0.98; 95% CI, 0.25-3.85), and discontinuation due to adverse events (OR, 1.55; 95% CI, 0.95-2.54) in patients treated with TNF inhibitors as a group were not significantly different from those treated with placebo in the control group. TNF inhibitors were generally safe for treatment of ankylosing spondylitis. These data may help guide clinical comparative decision making in the management of AS.

  19. Randomized trial comparing episiotomies with Braun-Stadler episiotomy scissors and EPISCISSORS-60®

    Directory of Open Access Journals (Sweden)

    Sawant G

    2015-06-01

    Full Text Available Ganpat Sawant, Divya Kumar Dr DY Patil Medical College and Hospital, Nerul, Navi Mumbai, India Introduction: Episiotomy angle is a crucial factor in causation of obstetric anal sphincter injuries (OASIS, which are the major cause of female bowel incontinence. Sutured episiotomies angled too close to the midline (<30 degree or too far away from the midline (.60 degree fail to unload the perineum sufficiently and predispose to OASIS. A 25-degree post-delivery episiotomy suture angle has a 10% risk of OASIS while 45-degree episiotomy is associated with 0.5% risk. To account for perineal distension at crowning, a 60-degree episiotomy incision is required to achieve 43–50 degree suture angles. We compared episiotomy suture angles with commonly used Braun-Stadler episiotomy scissors with the new fixed angle EPISCISSORS-60®. Methods: Ethical approval was obtained. A prospective cluster randomization design was chosen. Thirty-one patients were required in each group for a 12-degree difference with power at 90% and 5% significance. Sutured episiotomy angles and post-delivery linear distance from caudal end of the sutured episiotomy to the anus were measured with protractors and rulers. Two-tailed t-tests were used to compare the two groups. Results: Thirty-one nulliparae had episiotomies with EPISCISSORS-60®, 32 with Braun-Stadler. Mean age (25 versus 24.8 years was similar. EPISCISSORS-60® episiotomies were angled 12 degrees more laterally away from the anus compared to Braun-Stadler (40.6 degrees, 95% confidence interval [CI] ±2, interquartile range [IQR] 35–45 versus 28.3 degrees, 95% CI ±2, IQR 25–30, P<0.0001. The post-delivery linear distance from caudal end of the sutured episiotomy to the anus was 15 mm more with the EPISCISSORS-60® compared to Braun-Stadler (35 mm, 95% CI ±2.2, IQR =30–39 versus 19.5; 95% CI ±1.3, IQR =14.75–22.25 P<0.0001. EPISCISSORS-60® episiotomies measured longer (47 mm versus 40 mm, P<0.0001. There were

  20. Randomized trial comparing episiotomies with Braun-Stadler episiotomy scissors and EPISCISSORS-60(®).

    Science.gov (United States)

    Sawant, Ganpat; Kumar, Divya

    2015-01-01

    Episiotomy angle is a crucial factor in causation of obstetric anal sphincter injuries (OASIS), which are the major cause of female bowel incontinence. Sutured episiotomies angled too close to the midline (60 degree) fail to unload the perineum sufficiently and predispose to OASIS. A 25-degree post-delivery episiotomy suture angle has a 10% risk of OASIS while 45-degree episiotomy is associated with 0.5% risk. To account for perineal distension at crowning, a 60-degree episiotomy incision is required to achieve 43-50 degree suture angles. We compared episiotomy suture angles with commonly used Braun-Stadler episiotomy scissors with the new fixed angle EPISCISSORS-60(®). Ethical approval was obtained. A prospective cluster randomization design was chosen. Thirty-one patients were required in each group for a 12-degree difference with power at 90% and 5% significance. Sutured episiotomy angles and post-delivery linear distance from caudal end of the sutured episiotomy to the anus were measured with protractors and rulers. Two-tailed t-tests were used to compare the two groups. Thirty-one nulliparae had episiotomies with EPISCISSORS-60(®), 32 with Braun-Stadler. Mean age (25 versus 24.8 years) was similar. EPISCISSORS-60(®) episiotomies were angled 12 degrees more laterally away from the anus compared to Braun-Stadler (40.6 degrees, 95% confidence interval [CI] ±2, interquartile range [IQR] 35-45 versus 28.3 degrees, 95% CI ±2, IQR 25-30, P<0.0001). The post-delivery linear distance from caudal end of the sutured episiotomy to the anus was 15 mm more with the EPISCISSORS-60(®) compared to Braun-Stadler (35 mm, 95% CI ±2.2, IQR =30-39 versus 19.5; 95% CI ±1.3, IQR =14.75-22.25 P<0.0001). EPISCISSORS-60(®) episiotomies measured longer (47 mm versus 40 mm, P<0.0001). There were no OASIS cases in the EPISCISSORS-60(®) group versus one in the Braun-Stadler group. The EPISCISSORS-60(®) sutured episiotomies are much further away from the midline in angular and

  1. A randomized double-blind crossover trial comparing subthalamic and pallidal deep brain stimulation for dystonia

    DEFF Research Database (Denmark)

    Schjerling, Lisbeth; Hjermind, Lena E; Jespersen, Bo

    2013-01-01

    Object The authors' aim was to compare the subthalamic nucleus (STN) with the globus pallidus internus (GPi) as a stimulation target for deep brain stimulation (DBS) for medically refractory dystonia. Methods In a prospective double-blind crossover study, electrodes were bilaterally implanted...... in the STN and GPi of 12 patients with focal, multifocal, or generalized dystonia. Each patient was randomly selected to undergo initial bilateral stimulation of either the STN or the GPi for 6 months, followed by bilateral stimulation of the other nucleus for another 6 months. Preoperative and postoperative...

  2. Calorie Shifting Diet Versus Calorie Restriction Diet: A Comparative Clinical Trial Study

    OpenAIRE

    Davoodi, Sayed Hossein; Ajami, Marjan; Ayatollahi, Seyyed Abdulmajid; Dowlatshahi, Kamran; Javedan, Gholamali; Pazoki-Toroudi, Hamid Reza

    2014-01-01

    Background: Finding new tolerable methods in weight loss has largely been an issue of interest for specialists. Present study compared a novel method of calorie shifting diet (CSD) with classic calorie restriction (CR) on weight loss in overweight and obese subjects. Methods: Seventy-four subjects (body mass index ≥25; 37) were randomized to 4 weeks control diet, 6 weeks CSD or CR diets, and 4 weeks follow-up period. CSD consisted of three phases each lasts for 2 weeks, 11 days calorie re...

  3. A randomized trial comparing terlipressin and noradrenaline in patients with cirrhosis and septic shock.

    Science.gov (United States)

    Choudhury, Ashok; Kedarisetty, Chandan K; Vashishtha, Chitranshu; Saini, Deepak; Kumar, Sachin; Maiwall, Rakhi; Sharma, Manoj K; Bhadoria, Ajeet S; Kumar, Guresh; Joshi, Yogendra K; Sarin, Shiv K

    2017-04-01

    The choice of vasopressor for treating cirrhosis with septic shock is unclear. While noradrenaline in general is the preferred vasopressor, terlipressin improves microcirculation in addition to vasopressor action in non-cirrhotics. We compared the efficacy and safety of noradrenaline and terlipressin in cirrhotics with septic shock. Cirrhotics with septic shock underwent open label randomization to receive either terlipressin (n=42) or noradrenaline (n=42) infusion at a titrated dose. The primary outcome was mean arterial pressure (MAP) >65 mm Hg at 48 h. Baseline characteristics were comparable between the terlipressin and noradrenaline groups.SBP and pneumonia were major sources of sepsis. A higher proportion of patients on terlipressin were able to achieve MAP >65 mm of Hg (92.9% vs 69.1% P=.005) at 48 h. Subsequent discontinuation of vasopressor after hemodynamic stability was better with terlipressin (33.3% vs 11.9%, Pseptic shock and can serve as a useful drug. Terlipressin additionally provides early survival benefit and reduces the risk of variceal bleed. Lactate clearance is a better predictor of outcome even after achieving target MAP, suggesting the role of microcirculation in septic shock. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  4. Comparative efficacy of two daily use mouthrinses: randomized clinical trial using an experimental gingivitis model.

    Science.gov (United States)

    Charles, Christine Ann; McGuire, James Anthony; Sharma, Naresh Chandra; Qaqish, James

    2011-01-01

    Two antimicrobial agents, a fixed combination of essential oils (EOs) and 0.07% cetylpyridinium chloride (CPC) are found in commercially available mouthrinses, Listerine® Antiseptic and Crest® Pro HealthTM, respectively. Both mouthrinses have been shown to control dental plaque and gingivitis in short and longer term studies. The aim of this study was to determine the comparative effectiveness of these two mouthrinses using a 2-week experimental gingivitis model. Qualified subjects were randomly assigned to one of three mouthrinse groups: a fixed combination of EOs, 0.07% CPC, or negative control (C) rinse. Following baseline clinical assessments and a dental prophylaxis, subjects began a two-week period in which they rinsed twice daily with their assigned rinse and abstained from any mechanical oral hygiene procedures or other oral care products. Subjects were reassessed at the end of the two-week period. One hundred and forty-seven subjects were randomized and 142 completed this study. After two weeks use, the EOs rinse was superior (p plaque, and bleeding, with 9.4% and 6.6% reductions compared to CPC for gingivitis and plaque, respectively. Both rinses were superior to the negative control rinse (p mechanical oral hygiene influence.

  5. A randomized clinical trial comparing mandibular incisor proclination produced by fixed labial appliances and clear aligners.

    Science.gov (United States)

    Hennessy, Joe; Garvey, Thérèse; Al-Awadhi, Ebrahim A

    2016-09-01

    To compare the mandibular incisor proclination produced by fixed labial appliances and third generation clear aligners. Patients underwent a course of orthodontic treatment using either fixed labial appliances or clear aligners (Invisalign). Mandibular incisor proclination was measured by comparing pretreatment and near-end treatment lateral cephalograms. Eligibility criteria included adult patients with mild mandibular incisor crowding (clear aligner group. Baseline characteristics were similar for both groups: Fixed appliance mean crowding was 2.1 ± 1.3 mm vs clear aligner mean crowding, 2.5 ± 1.3 mm; pretreatment mean mandibular incisor inclination for the fixed appliance group was 90.8 ± 5.4° vs 91.6 ± 6.4° for the clear aligner group. Fixed appliances produced 5.3 ± 4.3° of mandibular incisor proclination. Clear aligners proclined the mandibular incisors by 3.4 ± 3.2°. The difference between the two groups was not statistically significant (P > .05). There was no difference in the amount of mandibular incisor proclination produced by clear aligners and fixed labial appliances in mild crowding cases.

  6. Vaginoscopy compared to traditional hysteroscopy for hysteroscopic sterilization. A randomized trial.

    Science.gov (United States)

    Chapa, Hector O; Venegas, Gonzalo

    2015-01-01

    To compare vaginoscopic hysteroscopic sterilization with traditional hysteroscopic approach for differences in pain, bilateral microinsert placement rates, and procedure time. We performed a prospective, randomized, single-blinded study of hysteroscopic sterilization using the Essure System. The study setting was an inner city ObGyn clinic. Ninety patients were randomized to either vaginoscopy or traditional approach. The traditional approach was speculum insertion, paracervical analgesia, and tenaculum. All procedures were done with a 5 mm, 30 degree rigid hysteroscope. Main outcome measures were pain scores (10-point visual analog scale), bilateral placement rates, and procedure times. Vaginoscopy was successful in 42/45 patients (93%). There was no statistically significant difference in pain-scores for microinsert placement between the groups (p = 0.71). First attempt, bilateral microinsert placement rate was 95% (40/42) with vaginoscopy and 95% (43/45) with traditional (p = 0.89). Time for treatment completion was 16 minutes (mean) (range, 13-21) in the traditional group versus vaginoscopy time of 9 minutes (mean) (range, 7-11) (p = 0.03). Hysteroscopic sterilization via vaginoscopy is feasible with bilateral microinsert rates comparable to those of traditional hysteroscopy. Vaginoscopy is associated with less overall discomfort and is faster to perform.

  7. Randomized clinical trial of fluid and salt restriction compared with a controlled liberal regimen in elective gastrointestinal surgery.

    Science.gov (United States)

    Kalyan, J P; Rosbergen, M; Pal, N; Sargen, K; Fletcher, S J; Nunn, D L; Clark, A; Williams, M R; Lewis, M P N

    2013-12-01

    Excessive intravenous fluid prescription may play a causal role in postoperative complications following major gastrointestinal resectional surgery. The aim of this study was to investigate whether fluid and salt restriction would decrease postoperative complications compared with a more modern controlled liberal regimen. In this observer-blinded single-site randomized clinical trial consecutive patients undergoing major gastrointestinal resectional surgery were randomized to receive either a liberal control fluid regimen or a restricted fluid and salt regimen. The primary outcome was postoperative complications of grade II and above (moderate to severe). Some 240 patients (194 colorectal resections and 46 oesophagogastric resections) were enrolled in the study; 121 patients were randomized to the restricted regimen and 119 to the control (liberal) regimen. During surgery the control group received a median (interquartile range) fluid volume of 2033 (1576-2500) ml and sodium input of 282 (213-339) mmol, compared with 1000 (690-1500) ml and 142 (93-218) mmol respectively in the restricted group. There was no significant difference in major complication rate between groups (38·0 and 39·0 per cent respectively). Median (range) hospital stay was 8 (3-101) days in the controls and 8 (range 3-76) days among those who received restricted fluids. There were four in-hospital deaths in the control group and two in the restricted group. Substantial differences in weight change, serum sodium, osmolality and urine : serum osmolality ratio were observed between the groups. There were no significant differences in major complication rates, length of stay and in-hospital deaths when fluid restriction was used compared with a more liberal regimen. ISRCTN39295230 (http://www.controlled-trials.com). © 2013 The Authors. British Journal of Surgery published by John Wiley & Sons Ltd on behalf of British Journal of Surgery Society Ltd.

  8. Efficacy and safety of the trans-obturator TVT-Abbrevo device in normal weight compared to overweight patients affected by stress urinary incontinence.

    Science.gov (United States)

    Tommaselli, Giovanni A; Napolitano, Valerio; Di Carlo, Costantino; Formisano, Carmen; Fabozzi, Annamaria; Nappi, Carmine

    2016-02-01

    To investigate if TVT-Abbrevo has similar outcomes in normal weight and overweight patients. Retrospective evaluation of 205 (105 normal weight women and 100 overweight women with BMI ≥ 25 kg/m(2)) undergone TVT-Abbrevo positioning with 12 month follow-up. Primary outcomes were objective cure rate (defined as no leakage during CST) and subjective cure rate ("very much improved"/"much improved" at PGI-I), secondary outcomes were intra-operative and post-operative complications. Objective cure rates in the normal and overweight groups were 96.2% and 94%, respectively (p=.47). Subjective cure rates in the normal and overweight groups were 90.5% and 88%, respectively (p=.57). ICIQ-SF, I-QoL and PGI-S scores significantly improved in both groups with no differences between the two groups. No serious intra- or post-operative complications were observed. No differences were observed in pain VAS scores and number of analgesic vials administered. TVT-Abbrevo seems to have similar efficacy and safety in normal weight and overweight women. More studies are needed to assess the efficacy of this device in frankly obese women and long-term outcomes. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  9. A Retrospective Study Comparing Tension-free Vaginal Tape and Transobturator Suburethral Tape for Surgical Treatment of Female Stress Urinary Incontinence — A Preliminary Report

    Directory of Open Access Journals (Sweden)

    Ching-Hwa Yang

    2007-12-01

    Conclusion: There appears to be equal efficacy between TVT and TVT-O for the surgical treatment of female SUI, but operative time was significantly shorter in the TVT-O group because intraoperative cystoscopic check-up is not required.

  10. Randomized Trial of Hepatic Artery Embolization for Hepatocellular Carcinoma Using Doxorubicin-Eluting Microspheres Compared With Embolization With Microspheres Alone

    Science.gov (United States)

    Do, Richard K.; Gonen, Mithat; Covey, Anne M.; Getrajdman, George I.; Sofocleous, Constantinos T.; Jarnagin, William R.; D’Angelica, Michael I.; Allen, Peter J.; Erinjeri, Joseph P.; Brody, Lynn A.; O’Neill, Gerald P.; Johnson, Kristian N.; Garcia, Alessandra R.; Beattie, Christopher; Zhao, Binsheng; Solomon, Stephen B.; Schwartz, Lawrence H.; DeMatteo, Ronald; Abou-Alfa, Ghassan K.

    2016-01-01

    Purpose Transarterial chemoembolization is accepted therapy for hepatocellular carcinoma (HCC). No randomized trial has demonstrated superiority of chemoembolization compared with embolization, and the role of chemotherapy remains unclear. This randomized trial compares the outcome of embolization using microspheres alone with chemoembolization using doxorubicin-eluting microspheres. Materials and Methods At a single tertiary referral center, patients with HCC were randomly assigned to embolization with microspheres alone (Bead Block [BB]) or loaded with doxorubicin 150 mg (LC Bead [LCB]). Random assignment was stratified by number of embolizations to complete treatment, and assignments were generated by permuted blocks in the institutional database. The primary end point was response according to RECIST 1.0 (Response Evaluation Criteria in Solid Tumors) using multiphase computed tomography 2 to 3 weeks post-treatment and then at quarterly intervals, with the reviewer blinded to treatment allocation. Secondary objectives included safety and tolerability, time to progression, progression-free survival, and overall survival. This trial is currently closed to accrual. Results Between December 2007 and April 2012, 101 patients were randomly assigned: 51 to BB and 50 to LCB. Demographics were comparable: median age, 67 years; 77% male; and 22% Barcelona Clinic Liver Cancer stage A and 78% stage B or C. Adverse events occurred with similar frequency in both groups: BB, 19 of 51 patients (38%); LCB, 20 of 50 patients (40%; P = .48), with no difference in RECIST response: BB, 5.9% versus LCB, 6.0% (difference, −0.1%; 95% CI, −9% to 9%). Median PFS was 6.2 versus 2.8 months (hazard ratio, 1.36; 95% CI, 0.91 to 2.05; P = .11), and overall survival, 19.6 versus 20.8 months (hazard ratio, 1.11; 95% CI, 0.71 to 1.76; P = .64) for BB and LCB, respectively. Conclusion There was no apparent difference between the treatment arms. These results challenge the use of doxorubicin

  11. Gaviscon® vs. omeprazole in symptomatic treatment of moderate gastroesophageal reflux. a direct comparative randomised trial

    Directory of Open Access Journals (Sweden)

    Pouchain Denis

    2012-02-01

    Full Text Available Abstract Background Medical management of GERD mainly uses proton pump inhibitors. Alginates also have proven efficacy. The aim of this trial was to compare short-term efficacy of an alginate (Gaviscon®, 4 × 10 mL/day and omeprazole (20 mg/day on GERD symptoms in general practice. Methods A 14-day multicentre randomised double-blind double-dummy non-inferiority trial compared Gaviscon® (4 × 10 mL/day and omeprazole (20 mg/day in patients with 2-6 day heartburn episodes weekly without alarm signals. The primary outcome was the mean time to onset of the first 24-h heartburn-free period after initial dosing. Secondary outcomes were the proportion of patients without heartburn by D7, pain relief by D7, and reduction in pain intensity by D7 and D14. Results 278 patients were recruited; 120 were included in the Gaviscon® group and 121 in the omeprazole group for the per protocol non-inferiority analysis. The mean time to onset of the first 24-h heartburn-free period after initial dosing was 2.0 (± 2.2 days for Gaviscon® and 2.0 (± 2.3 days for omeprazole (p = 0.93; mean intergroup difference was 0.01 ± 1.55 days (95% CI = -0.41 to 0.43: i.e., less than the lower limit of the 95% CI of -0.5 days predetermined to demonstrate non-inferiority. The mean number of heartburn-free days by D7 was significantly greater in the omeprazole group: 3.7 ± 2.3 days vs. 3.1 ± 2.1 (p = 0.02. On D7, overall quality of pain relief was slightly in favour of omeprazole (p = 0.049. There was no significant difference in the reduction in pain intensity between groups by D7 (p = 0.11 or D14 (p = 0.08. Tolerance and safety were good and comparable in both groups. Conclusion Gaviscon® was non-inferior to omeprazole in achieving a 24-h heartburn-free period in moderate episodic heartburn, and is a relevant effective alternative treatment in moderate GERD in primary care. Trial registration ISRCTN62203233.

  12. Ten year results of a randomised trial comparing two conservative treatment strategies for small size breast cancer

    International Nuclear Information System (INIS)

    Mariani, L.; Salvadori, B.; Marubini, E.; Conti, A.R.; Rovini, D.; Cusumano, F.; Rosolin, T.; Andreola, S.; Zucali, R.; Rilke, F.; Veronesi, U.

    1998-01-01

    We report the 10-year results of a randomised clinical trial in which two different breast conservation treatment strategies were compared in women with small, non-metastatic primary breast cancer: quadrantectomy, axillary dissection and radiotherapy (QUART) versus tumorectomy and axillary dissection followed by external radiotherapy and a boost with 192 Ir implantation (TART). No second surgery was given to women with affected surgical margins. Axillary node positive women received adjuvant medical therapy. From 1985-1987, this trial accrued 705 patients, 360 in the QUART and 345 in the TART arm. Crude cumulative incidence curves for intrabreast tumour recurrence (IBTR) and metastases as first events and mortality curves in each of the two treatment arms were computed. A crude cumulative incidence curve of IBTR as a second event (in women who had already had a local recurrence) was also computed. The two groups were compared in terms of hazard for IBTR, metastases or death occurrence by using Cox regression models, both with and without adjustment for patient age, tumour size, number of metastatic axillary nodes and histology. Possible interactions between the aforementioned prognostic factors and the type of surgery were also investigated. The two groups were well matched for baseline patient and tumour characteristics, the only exception being resection margins, which were more often positive in the TART group. At the Cox model, a significant difference between groups was detected for IBTR (P<0.0001), but not for distant metastases and overall survival. In particular, 5- and 10-year estimates of crude cumulative incidence of IBTR were 4.7 and 7.4% in the QUART group, and 11.6 and 18.6% in the TART group. The difference was not substantially affected by patient or disease characteristics. Likewise, the status of resection margins in women who underwent TART treatment did not significantly influence the risk of occurrence of IBTRs. Finally, the rate of second IBTR

  13. Diamorphine for pain relief in labour : a randomised controlled trial comparing intramuscular injection and patient-controlled analgesia.

    Science.gov (United States)

    McInnes, Rhona J; Hillan, Edith; Clark, Diana; Gilmour, Harper

    2004-10-01

    To compare the efficacy of diamorphine administered by a patient-controlled pump (patient-controlled analgesia) with intramuscular administration for pain relief in labour. Randomised controlled trial. The South Glasgow University Hospitals NHS Trust. Primigravidae and multigravidae in labour at term (37-42 weeks). Women were randomised in labour to the study (patient-controlled analgesia) or control group (intramuscular). Randomisation was achieved through a random permuted block design stratified by parity. Study group women were given a loading dose of 1.2 mg diamorphine intravenously and then attached to the pump. Control group women received intramuscular diamorphine as per hospital protocol. Participants were also given 3 mg of buccal Stemetil. Data were collected throughout labour and at six postnatal weeks. Analgesia requirements during labour and women's satisfaction with the method of pain relief. Women in the study group (patient-controlled analgesia) used significantly less diamorphine than women in the control group (intramuscular) but were significantly more likely to state that they were very dissatisfied with their use of diamorphine and were significantly more likely to opt out of the trial before the birth of the baby. The majority of women in both groups used other analgesia concurrent with diamorphine such as Entonox, aromatherapy or TENS. Patient-controlled analgesia administration of diamorphine for the relief of pain in labour offers no significant advantages over intramuscular administration. The results also suggest that diamorphine is a poor analgesic for labour pain irrespective of the mode of administration.

  14. Design of Lamifuse: a randomised, multi-centre controlled trial comparing laminectomy without or with dorsal fusion for cervical myeloradiculopathy

    Directory of Open Access Journals (Sweden)

    Grotenhuis J André

    2007-11-01

    Full Text Available Abstract Background laminectomy is a valuable surgical treatment for some patients with a cervical radiculomyelopathy due to cervical spinal stenosis. More recently attention has been given to motion of the spinal cord over spondylotic spurs as a cause of myelopathic changes. Immobilisation by fusion could have a positive effect on the recovery of myelopathic signs or changes. This has never been investigated in a prospective, randomised trial. Lamifuse is an acronyme for laminectomy and fusion. Methods/Design Lamifuse is a multicentre, randomised controlled trial comparing laminectomy with and without fusion in patients with a symptomatic cervical canal stenosis. The study population will be enrolled from patients that are 60 years or older with myelopathic signs and/or symptoms due to a cervical canal stenosis. A kyphotis shape of the cervical spine is an exclusion criterium. Each treatment arm needs 30 patients. Discussion This study will contribute to the discussion whether additional fusion after a cervical laminectomy results in a better clinical outcome. ISRCT number ISRCTN72800446

  15. A randomised trial comparing weight loss with aerobic exercise in overweight individuals with coronary artery disease

    DEFF Research Database (Denmark)

    Pedersen, Lene Rørholm Engelbrecht; Olsen, Rasmus H; Jürs, Anders

    2015-01-01

    BACKGROUND: We aimed to compare the effect of aerobic interval training (AIT) versus a low energy diet (LED) on physical fitness, body composition, cardiovascular risk factors and symptoms in overweight individuals with coronary artery disease (CAD). METHODS AND DESIGN: Seventy non...... per protocol. VO2peak (mL/kg fat free mass(0.67)/min) increased by 10.4% (p = 0.002) following AIT, whereas no change was observed after LED (-3.0%, p = 0.095). The LED group lost 10.6% body weight and 26.6% body fat mass (p .... Waist circumference and visceral abdominal fat were reduced by both interventions but were most pronounced following LED (between-group, p 

  16. How to compare the social foundations of science culture: A trial with five cities in Korea.

    Science.gov (United States)

    Song, Jinwoong; Chung, Minkyung; Choi, Eunjeong; Kim, Leekyoung; Cho, Sook-Kyoung

    2013-01-01

    Though there have been several indicator systems to monitor the status quo of science and technology and of scientific literacy, few are especially designed for science culture, especially for its social dimension. Furthermore there is little agreement on how to measure it. In a previous study, an indicator system, SCI (Science Culture Indicators), had been developed to monitor the status quo of the science culture of a nation at both individual and social dimensions. The purpose of this study was to explore a practical way to measure and compare local cities' social foundation of science culture by revising and standardizing the social dimension of SCI and by applying it to five metropolitan cities in Korea. Despite some limits, the results of this study appear not only to reflect the cities' current situations but also to show the strength and weakness of their social foundation of science culture.

  17. Treatment of helicobacter pylori infection; a controlled randomized comparative clinical trial

    International Nuclear Information System (INIS)

    Mehmood, A.; Usmanghani, K.; Mohiuddin, E.; Akram, M.

    2010-01-01

    Helicobacter pylori induces chronic inflammation of the underlying gastric mucosa and is strongly linked to the development of duodenal and gastric carcinoma. A study was conducted to evaluate the efficacy of Pylorex, a herbal formulation, for treatment of H. pylori infection as compared to triple allopathic therapy (Omeprazole, Amoxicillin, Metronidazole). The therapeutic evaluations of these medicines were conducted on 97 clinically and immunologically diagnosed cases of H. pylori infection. H. pylori was eradicated in 16 (32.6%) out of 49 patients by the use of triple allopathic therapy (Control drugs), and in 9 (18.7%) out of 48 patients by the use of Pylorex (Test drug). Pylorex possesses a therapeutic value for the treatment of H. pylori associated symptoms but the eradication rate is superior in triple allopathic therapy. (author)

  18. Sea state estimation from an advancing ship – A comparative study using sea trial data

    DEFF Research Database (Denmark)

    Nielsen, Ulrik Dam; Stredulinsky, David C.

    2012-01-01

    and a buoy is clear, although the ship is moving with a forward speed and, in general, is characterised by a more complex underwater geometry. Thus, it is possible to obtain an estimate of the wave spectrum at the location of an advancing ship by processing its wave-induced responses similar to the situation......Onboard sea state estimation is relevant for evaluation of ship operations at sea. Means to obtain the sea state at a fixed position include a traditional wave rider buoy, where motion measurements of the buoy are processed to give the (directional) wave spectrum. The analogy between a ship...... of a traditional wave rider buoy. The paper studies the ‘wave buoy analogy’, and a large set of full-scale motion measurements is considered. It is shown that the wave buoy analogy gives fairly accurate estimates of integrated sea state parameters when compared to corresponding estimates from real wave rider buoys...

  19. Randomized clinical trial comparing oral prednisone (50 mg) with placebo before laparoscopic cholecystectomy

    DEFF Research Database (Denmark)

    Bisgaard, Thue; Schulze, S.; Hjortso, N.C.

    2008-01-01

    cholecystectomy. Methods In a double-blind placebo-controlled study, 200 patients were randomized to oral administration of prednisone (50 mg) or placebo 2 h before laparoscopic cholecystectomy. Patients received a similar standardized anaesthetic, surgical, and analgesic treatment. The primary outcome was pain...... the first 24 h. Side-effects and 30-day follow-up for morbidity were registered. Results Data from 184 patients were available for statistical analysis. There were no significant differences in side-effects or complications between the surgical groups (P > 0.05). No significant intergroup differences in 24......-h pain, fatigue or malaise scores or any other variables were found (P > 0.05). Conclusion There is no important clinical gain of preoperative oral steroid administration compared with placebo in patients undergoing laparoscopic cholecystectomy Udgivelsesdato: 2008/2...

  20. Comparative clinical trial: fluconazole alone or associated with topical ketoconazole in the treatment of pityriasis versicolor.

    Science.gov (United States)

    Badri, Talel; Hammami, Houda; Bzioueche, Neila; Zouari, Bechir; Mokhtar, Inçaf

    2016-02-01

    The efficacy of ketoconazole and fluconazole in pityriasis versicolor had been proved. To compare the efficacy and the safety of two doses of fluconazole given 1 week apart alone or associated to ketoconazole shampoo. Our study included all patients with pityriasis versicolor who attended in dermatology department of Habib Thameur Hospital, Tunis (over a 21-month period). During the considered period, patients were randomly assigned in two study groups: G1 receiving fluconazole two doses 300mg given 1 week apart with G2 taken an association of fluconazole (two doses 300mg given 1 week apart) and ketoconazole shampoo the first day. Seventy one patients were enrolled in our study: 35 in the fluconazole group and 36 in the fluconazole associated to ketoconazole shampoo comparator group. The mean age was 29.1 years [16-70 years].  Concerning the clinical form, 27% had macular lesions, 24% had plaques and 49% had mixed form. Lesions werehyperchromic52%; hypochromic 15% and erythematous 6%. As for main location, 67% had lesions on the neck; 66% on the trunk, 60% on the shoulders. At the end of the study, there was no significant difference in clinical presentation and in improvement rate of pityriasis versicolor between fluconazole and association of fluconazole and ketoconazole shampoo ((p=0.13 at day 14, p=0.57 at day 28 and p=0.2 at day56). In this study, we have shown that the improvement rate of PV treated with two doses of 300 mg of fluconazole with one week interval was similar to those of an association of one application of ketoconazole shampoo and the same dose of fluconazole.

  1. Comparative treatment trial of augmentin versus cefaclor for acute otitis media with effusion.

    Science.gov (United States)

    Odio, C M; Kusmiesz, H; Shelton, S; Nelson, J D

    1985-05-01

    A total of 150 children with acute otitis media were randomly allocated to treatment with amoxicillin-potassium clavulanate (Augmentin) or with cefaclor. Each drug was given in a daily dosage of approximately 40 mg/kg in three divided doses for ten days. Tympanocentesis done before treatment yielded specimens that contained pneumococcus or Haemophilus sp or both in 67% of specimens. Viridans group streptococci were isolated from 10% of specimens and Branhamella catarrhalis from 6%. Patients were scheduled for follow-up examinations at midtreatment, end of therapy, and at 30, 60, and 90 days. Of the 150 children, 130 were evaluable. Five of 60 patients (8%) treated with cefaclor were considered therapeutic failures because of persistent purulent drainage and isolation of the original pathogen or suprainfection. There were no failures among patients treated with Augmentin (P = .019). Rates of relapse, recurrent acute otitis media with effusion, and persistent middle ear effusion were comparable in the two groups of patients. Diaper rash, or loose stools, or both were significantly more common in children treated with Augmentin (34%) than in those taking cefaclor (12%), but in no case was it necessary to discontinue medication because of these mild side effects (P = .002). Cefaclor therapy was discontinued in one patient because of severe abdominal pain and vomiting. In this study, treatment with Augmentin was superior to treatment with cefaclor in the acute phase of acute otitis media with effusion, but Augmentin produced more adverse effects. The rates of persistent middle ear effusion and recurrent acute otitis media with effusion were comparable with the two regimens.

  2. A randomized controlled trial to compare pregabalin with gabapentin for postoperative pain in abdominal hysterectomy

    Directory of Open Access Journals (Sweden)

    Anju Ghai

    2011-01-01

    Full Text Available Background: Pregabalin is a potent ligand for alpha-2-delta subunit of voltage-gated calcium channels in the central nervous system, which exhibits potent anticonvulsant, analgesic and anxiolytic activity. The pharmacological activity of pregabalin is similar to that of gabapentin and shows possible advantages. Although it shows analgesic efficacy against neuropathic pain, very limited evidence supports its postoperative analgesic efficacy. We investigated its analgesic efficacy in patients experiencing acute pain after abdominal hysterectomy and compared it with gabapentin and placebo. Methods: A randomized, double-blind, placebo-controlled study was conducted in 90 women undergoing abdominal hysterectomy who were anaesthetized in a standardized fashion. Patients received 300 mg pregabalin, 900 mg gabapentin or placebo, 1-2 hours prior to surgery. Postoperative analgesia was administered at visual analogue scale (VAS ≥3. The primary outcome was analgesic consumption over 24 hours and patients were followed for pain scores, time to rescue analgesia and side effects as secondary outcomes. Results: The diclofenac consumption was statistically significant between pregabalin and control groups, and gabapentin and control groups; however, pregabalin and gabapentin groups were comparable. Moreover, the consumption of tramadol was statistically significant among all the groups. Patients in pregabalin and gabapentin groups had lower pain scores in the initial hour of recovery. However, pain scores were subsequently similar in all the groups. Time to first request for analgesia was longer in pregabalin group followed by gabapentin and control groups. Conclusion: A single dose of 300 mg pregabalin given 1-2 hours prior to surgery is superior to 900 mg gabapentin and placebo after abdominal hysterectomy. Both the drugs are better than placebo.

  3. Randomized controlled trial comparing pudendal nerve block under ultrasound and fluoroscopic guidance.

    Science.gov (United States)

    Bellingham, Geoff A; Bhatia, Anuj; Chan, Chin-Wern; Peng, Philip W

    2012-01-01

    Although fluoroscopy is an established imaging modality for pudendal nerve block, ultrasound (US) technique allows physicians better visualization of anatomic structures. This study aimed to compare the effectiveness and safety between the US- and fluoroscopy-guided techniques. A randomized, single-blind, split-plot design was used to conduct the study. Twenty-three patients undergoing bilateral pudendal nerve blocks received US-guided injections to either the left or right side, whereas the contralateral side received a fluoroscopic-guided injection in randomized sequence. Injections consisted of 4 mL of 0.5% bupivacaine and 40 mg methylprednisone. The primary outcome was the success of the block in the distribution of the pudendal nerve along the perineum, rated as either absent, moderate, or strong. Secondary outcomes were the time to administer the blocks, quality of visualization of anatomic structures using US and fluoroscopy, distance of the final US-guided needle position from the ischial spine, and incidence of adverse effects. No differences in the degree of neural blockade were noted between US- or fluoroscopic-guided techniques for either temperature or pinprick blockade. Time to complete the procedure was significantly longer using US compared with fluoroscopy (219 [SD, 65] and 428 [SD, 151] secs, P < 0.0001). No significant differences were noted regarding the occurrence of adverse effects between the 2 techniques. Ultrasound-guided pudendal nerve blockade is as accurate as fluoroscopically guided injections when performed by an experienced clinician. However, the former took a longer time to perform.

  4. Cosmetic outcomes of laparoendoscopic single-site hysterectomy compared with multi-port surgery: randomized controlled trial.

    Science.gov (United States)

    Song, Taejong; Cho, Juhee; Kim, Tae-Joong; Kim, Im-Ryung; Hahm, Tae Soo; Kim, Byoung-Gie; Bae, Duk-Soo

    2013-01-01

    To compare cosmetic satisfaction with laparoendoscopic single-site surgery (LESS) compared with multi-port surgery. Randomized controlled trial (Canadian Task Force classification I). University hospital. Twenty women who underwent laparoscopically-assisted vaginal hysterectomy (LAVH) via LESS or multi-port surgery. Laparoendoscopic single-site surgery or multi-port surgery. Cosmetic satisfaction was assessed using the Body Image Questionnaire at baseline and at 1, 4, and 24 weeks after surgery. Of the 20 LESS procedures, 1 was converted to multi-port surgery because of severe adhesions, and 1 woman assigned to undergo multi-port surgery was lost to follow-up. The 2 surgery groups did not differ in clinical demographic data and surgical results or postoperative pain scores at 12, 24, and 36 hours. Compared with the multi-port group, the LESS group reported significantly higher cosmetic satisfaction at 1, 4, and 24 weeks after surgery (p surgery, LESS is not only a feasible approach with comparable operative outcomes but also has an advantage insofar as cosmetic outcome. Copyright © 2013 AAGL. Published by Elsevier Inc. All rights reserved.

  5. Economic analysis comparing induction of labour and expectant management for intrauterine, growth restriction at term (DIGITAT trial)

    NARCIS (Netherlands)

    Vijgen, Sylvia M. C.; Boers, Kim E.; Opmeer, Brent C.; Bijlenga, Denise; Bekedam, Dick J.; Bloemenkamp, Kitty W. M.; de Boer, Karin; Bremer, Henk A.; le Cessie, Saskia; Delemarre, Friso M. C.; Duvekot, Johannes J.; Hasaart, Tom H. M.; Kwee, Anneke; van Lith, Jan M. M.; van Meir, Claudia A.; van Pampus, Maria G.; van der Post, Joris A. M.; Rijken, Monique; Roumen, Frans J. M. E.; van der Salm, Paulien C. M.; Spaandermann, Marc E. A.; Willekes, Christine; Wijnen, Ella J.; Mol, Ben W. J.; Scherjon, Sicco A.

    2013-01-01

    Objective: Pregnancies complicated by intrauterine growth restriction (IUGR) are at increased risk for neonatal morbidity and mortality. The Dutch nationwide disproportionate intrauterine growth intervention trial at term (DIGITAT trial) showed that induction of labour and expectant monitoring were

  6. Randomised, controlled trial of alternating pressure mattresses compared with alternating pressure overlays for the prevention of pressure ulcers: PRESSURE (pressure relieving support surfaces) trial.

    Science.gov (United States)

    Nixon, Jane; Cranny, Gillian; Iglesias, Cynthia; Nelson, E Andrea; Hawkins, Kim; Phillips, Angela; Torgerson, David; Mason, Su; Cullum, Nicky

    2006-06-17

    To compare whether differences exist between alternating pressure overlays and alternating pressure mattresses in the development of new pressure ulcers, healing of existing pressure ulcers, and patient acceptability. Pragmatic, open, multicentre, randomised controlled trial. 11 hospitals in six NHS trusts. 1972 people admitted to hospital as acute or elective patients. Participants were randomised to an alternating pressure mattress (n = 982) or an alternating pressure overlay (n = 990). The proportion of participants developing a new pressure ulcer of grade 2 or worse; time to development of new pressure ulcers; proportions of participants developing a new ulcer within 30 days; healing of existing pressure ulcers; and patient acceptability. Intention to treat analysis found no difference in the proportions of participants developing a new pressure ulcer of grade 2 or worse (10.7% overlay patients, 10.3% mattress patients; difference 0.4%, 95% confidence interval--2.3% to 3.1%, P = 0.75). More overlay patients requested change owing to dissatisfaction (23.3%) than mattress patients (18.9%, P = 0.02). No difference was found between alternating pressure mattresses and alternating pressure overlays in the proportion of people who develop a pressure ulcer. ISRCTN 78646179.

  7. Two-year follow-up of the MOSAIC trial: A multicenter randomized controlled trial comparing two psychological treatments in adult outpatients with broadly defined anorexia nervosa.

    Science.gov (United States)

    Schmidt, Ulrike; Ryan, Elizabeth G; Bartholdy, Savani; Renwick, Bethany; Keyes, Alexandra; O'Hara, Caitlin; McClelland, Jessica; Lose, Anna; Kenyon, Martha; Dejong, Hannah; Broadbent, Hannah; Loomes, Rachel; Serpell, Lucy; Richards, Lorna; Johnson-Sabine, Eric; Boughton, Nicky; Whitehead, Linette; Bonin, Eva; Beecham, Jennifer; Landau, Sabine; Treasure, Janet

    2016-08-01

    This study reports follow-up data from a multicenter randomized controlled trial (n = 142) comparing the Maudsley Model of Anorexia Nervosa Treatment for Adults (MANTRA) with Specialist Supportive Clinical Management (SSCM) in outpatients with broadly defined anorexia nervosa (AN). At 12 months postrandomization, all patients had statistically significant improvements in body mass index (BMI), eating disorder (ED) symptomatology and other outcomes with no differences between groups. MANTRA was more acceptable to patients. The present study assessed whether gains were maintained at 24 months postrandomization. Follow-up data at 24 months were obtained from 73.2% of participants. Outcome measures included BMI, ED symptomatology, distress, impairment, and additional service utilization during the study period. Outcomes were analyzed using linear mixed models. There were few differences between groups. In both treatment groups, improvements in BMI, ED symptomatology, distress levels, and clinical impairment were maintained or increased further. Estimated mean BMI change from baseline to 24 months was 2.16 kg/m(2) for SSCM and 2.25 kg/m(2) for MANTRA (effect sizes of 1.75 and 1.83, respectively). Most participants (83%) did not require any additional intensive treatments (e.g., hospitalization). Two SSCM patients became overweight through binge-eating. Both treatments have value as outpatient interventions for patients with AN. © 2016 Crown copyright. International Journal of Eating Disorders. (Int J Eat Disord 2016; 49:793-800). © 2016 Crown copyright. International Journal of Eating Disorders.

  8. Randomized prospective trial comparing ultrasonography and pelvic examination for preterm labor surveillance.

    Science.gov (United States)

    Lorenz, R P; Comstock, C H; Bottoms, S F; Marx, S R

    1990-06-01

    This study was designed to compare the effectiveness of cervical assessment by either ultrasonography or bimanual pelvic examination in a program for preterm labor surveillance. Patients (n = 57) at risk for preterm birth were seen once a week for patient education, review of symptoms, and cervical evaluation. Cervical evaluation was assigned randomly to either ultrasonographic evaluation or pelvic examination. The groups did not differ in demographic or obstetric factors. The overall rate of prematurity was 18%. Preterm labor was more frequent with ultrasonographic evaluation (52%) than with pelvic examination (25%) (p less than 0.05). The group evaluated by ultrasonography received oral tocolytic agents (55%) more than the group that had pelvic examinations (21%) (p less than 0.02). The groups did not differ in infant birth weights, length of gestation, or neonatal mortality or morbidity. In this prospective randomized study of patients at risk for preterm birth, patients under surveillance by ultrasonographic assessment of the cervix did not fare better than those assigned to bimanual examination.

  9. Clinical trial comparing autogenous fascia lata sling and Gore-Tex suspension in bilateral congenital ptosis.

    Science.gov (United States)

    Elsamkary, Mahmoud Ahmed; Roshdy, Maged Maher Salib

    2016-01-01

    To study the effect of autogenous fascia lata sling (AFLS) versus Gore-Tex suspension (GTS) regarding the functional and aesthetic outcomes in patients with bilateral congenital ptosis. A prospective comparative randomized single-center study enrolled 110 patients with bilateral congenital ptosis. One group (n=55) underwent AFLS and the second group (n=55) underwent GTS. Exclusion criteria were good levator function, absent Bell's phenomenon, and abnormal ocular motility. Follow-up period was 2 years. Functional outcome was measured from digital photos by analysis of upper eyelid margin position relative to the superior limbus and classified as very good (5 mm), and recurrent. Aesthetic outcome was assessed in terms of lid contour, symmetry of eyelid height, and lid crease presence. Complications were also reported. Failure rate (recurrence and complications) was less in AFLS (P=0.035). Symmetrical lid height and good contour were more frequently attained by AFLS (P=0.007 and 0.047, respectively). However, the frequency of very good, good, poor, recurrence, lagopthalmos, ectropion, infection, and formed lid crease individually showed no statistically significant difference (P=0.252, 0.482, 1, 0.489, 0.438, 1, 0.618, and 0.506, respectively). AFLS is a better choice in surgery for patients with bilateral congenital ptosis because it has fewer complications and a lesser recurrence rate than GTS.

  10. Marrow transplantation for leukemia following fractionated total body irradiation. A comparative trial of methotrexate and cyclosporine

    International Nuclear Information System (INIS)

    Irle, C.; Deeg, H.J.; Buckner, C.D.; Swedish Hospital Medical Center, Seattle, WA; Veterans Administration Hospital, Seattle, WA; Washington Univ., Seattle

    1985-01-01

    Fifty-six patients, 30-47 yr of age, with leukemia in relapse received allogeneic marrow transplants from HLA-identical siblings. All patients were treated with cyclophosphamide (120 mg/kg) and 7 daily fractions of 2.25 Gy of total body irradiation (TBI) for seven consecutive days. Nine patients (16%) are currently alive, free of disease, 324-845 days from transplantation. Actuarial relapse and survival rates at 2 yr were 56% and 9.5% respectively. These data were not remarkably different from those in previous studies using 10 Gy of TBI administered as a single dose. Thirty patients were randomized to receive methotrexate (MTX) and 26 to receive cyclosporine (CSP) as postgrafting prophylaxis for acute graft-versus-host disease (GVHD). Probability of developing significant acute GVHD by day 100 post-transplant was 71% for patients in the MTX group and 45% for patients in the CSP group (p<0.05). Probability of relapse was 37% for patients in the MTX group and 70% for patients in the CSP group (p<0.05). Transplant-related deaths were more frequent in the MTX group and leukemic deaths more frequent in the CSP group although this may have been related to an uneven distribution of high-risk patients. Long term disease-free survival was comparable. (author)

  11. Randomized clinical trial comparing oral prednisone (50 mg) with placebo before laparoscopic cholecystectomy

    DEFF Research Database (Denmark)

    Bisgaard, Thue; Schulze, S.; Hjortso, N.C.

    2008-01-01

    Background Intravenous administration of dexamethasone 90 min before laparoscopic cholecystectomy improves surgical outcome but may be impractical. The objective of this study was to assess the clinical efficacy of oral self-administration of prednisone 2 h before ambulatory laparoscopic cholecys......Background Intravenous administration of dexamethasone 90 min before laparoscopic cholecystectomy improves surgical outcome but may be impractical. The objective of this study was to assess the clinical efficacy of oral self-administration of prednisone 2 h before ambulatory laparoscopic...... cholecystectomy. Methods In a double-blind placebo-controlled study, 200 patients were randomized to oral administration of prednisone (50 mg) or placebo 2 h before laparoscopic cholecystectomy. Patients received a similar standardized anaesthetic, surgical, and analgesic treatment. The primary outcome was pain......-h pain, fatigue or malaise scores or any other variables were found (P > 0.05). Conclusion There is no important clinical gain of preoperative oral steroid administration compared with placebo in patients undergoing laparoscopic cholecystectomy Udgivelsesdato: 2008/2...

  12. A randomized controlled trial comparing instructions regarding unsafe response options in a MCQ examination.

    Science.gov (United States)

    Tweed, Mike; Wilkinson, Tim

    2009-01-01

    Marking of multiple choice type examinations often just takes account of the correct responses. This may encourage guessing of incorrect and potentially unsafe responses. Ideally responses should contain a high proportion of correct, unsafe and the use of 'don't know' response rather than incorrect. This study explored the effect of instructions on responses. Fourth- and fifth-year students sitting for an optional multiple choice examination were randomized to receive one of four instruction options: number-correct marking (the control group); alert to unsafe; mark deduction for unsafe; or correction for guessing. A total of 210 students sat the test. For the fourth-year cohort, compared with the control group, being alerted to unsafe and mark deduction for unsafe or incorrect responses were associated with graduated increases in the use of 'don't know' and reductions in incorrect responses. For the fifth-year cohort, there were no differences in responses between options. The fifth-year cohort, gave more correct, and fewer incorrect, unsafe and 'don't know' responses. Both the year group and instructions had an effect. Being alerted to potentially unsafe responses, even when there is no mark deduction penalty, had an effect, although mark deduction still had the greatest effect. Assessment instructions may give subliminal messages that have important consequences.

  13. A Danish randomized trial comparing breast-preserving therapy with mastectomy in mammary carcinoma

    International Nuclear Information System (INIS)

    Blichert-Toft, M.; Brincker, H.; Andersen, J.A.; Andersen, K.W.; Axelsson, C.K.; Mouridsen, H.T.; Dombernowsky, P.; Overgaard, M.; Gadeberg, C.; Knudsen, G.; Borgeskov, S.; Bertelsen, S.; Knudsen, J.B.; Hansen, J.B.; Poulsen, P.E.; Willumsen, H.; Schousen, P.; Froberg, D.; Oernsholt, J.; Andersen, M.; Olesen, S.; Skovgaard, S.; Oester, M.; Schumacher, H.; Lynderup, E.K.; Holm, C.N.

    1988-01-01

    The present study comprises 847 women operated upon for invasive breast carcinoma at 19 surgical departments and enrolled in protocol DBCG-82TM from January 1983 to November 1987. Among them 662 (78%) were allocated for breast-preserving therapy or mastectomy by randomization, while 185 patients (22%) did not accept randomization. Within the randomized group 6% could not be entered into adjuvant protocols, i.e. subsequent programmes of postoperative therapy and follow-up. This left 619 evaluable patients. In the non-randomized series 26% did not fulfil the demands for entrance into the adjuvant protocols, leaving 136 evaluable patients, 60 of whom had chosen a breast-preserving operation and 76 mastectomy. In the randomized series the patients in the two treatment arms were comparable in age, menopausal status, site of tumour, pathoanatomical diameter of the tumour, number of removed axillary lymph nodes, number of metastatic axillary lymph nodes, and distribution on adjuvant regimens. Ninety per cent of the patients in the randomized group accepted the method offered, whereas 10% declined and wanted the alternate form of operation. The median follow-up period was approximately 1.75 years. The cumulative recurrence rate in the randomized group was 13% and in the non-randomized group 7%. These results are preliminary. Life-table analyses have not so far demonstrated differences in recurrence-free survival either in the randomized or the non-randomized series. (orig.)

  14. A randomized trial comparing perinatal outcomes using insulin detemir or neutral protamine Hagedorn in type 1 diabetes

    DEFF Research Database (Denmark)

    Hod, Moshe; Mathiesen, Elisabeth R; Jovanovič, Lois

    2014-01-01

    OBJECTIVE: This randomized controlled trial aimed to compare the efficacy and safety of insulin detemir (IDet) with neutral protamine Hagedorn (NPH), both with insulin aspart, in pregnant women with type 1 diabetes. The perinatal and obstetric pregnancy outcomes are presented. METHODS: Subjects...... tolerated as NPH as regards perinatal outcomes in pregnant women with type 1 diabetes and no safety issues were identified....... from the IDet arm than the NPH arm (treatment difference: 0.49 weeks [95% CI 0.11;0.88], p = 0.012, linear regression). Sixteen children had a malformation (IDet: n = 8/142, 5.6%; NPH: n = 8/145, 5.5%). The incidence of adverse events was similar between treatments. CONCLUSION: IDet is as well...

  15. Comparative study of hemodynamic changes caused by diazepam and midazolam during third molar surgery: a randomized controlled trial.

    Science.gov (United States)

    de Morais, Hécio Henrique Araújo; Barbalho, Jimmy Charles Melo; de Holanda Vasconcellos, Ricardo José; Landim, Fabricio Souza; da Costa Araújo, Fábio Andrey; de Souza Dias, Tasiana Guedes

    2015-09-01

    The aim of the present study was to compare hemodynamic changes using midazolam 7.5 mg and diazepam 10.0 mg during the surgical removal of symmetrically positioned third molars. A prospective, randomized, double-blind, clinical trial was carried out involving 120 patients divided into three groups: Group 1 (diazepam and placebo), Group 2 (midazolam and placebo), and Group 3 (diazepam and midazolam). Each subject underwent two surgeries on separate occasions under local anesthesia. The following parameters were assessed at five different times (T0, T1, T2, T3, and T4): systolic, diastolic, and mean blood pressure (SBP, DBP, and MBP, respectively); heart rate (HR); oxygen saturation (SpO(2)); rate pressure product (RPP); and pressure rate quotient (PRQ). Statistically significant differences were found regarding heart rate at T2 and T3 (p third molar surgery.

  16. Sample size for comparing negative binomial rates in noninferiority and equivalence trials with unequal follow-up times.

    Science.gov (United States)

    Tang, Yongqiang

    2017-05-25

    We derive the sample size formulae for comparing two negative binomial rates based on both the relative and absolute rate difference metrics in noninferiority and equivalence trials with unequal follow-up times, and establish an approximate relationship between the sample sizes required for the treatment comparison based on the two treatment effect metrics. The proposed method allows the dispersion parameter to vary by treatment groups. The accuracy of these methods is assessed by simulations. It is demonstrated that ignoring the between-subject variation in the follow-up time by setting the follow-up time for all individuals to be the mean follow-up time may greatly underestimate the required size, resulting in underpowered studies. Methods are provided for back-calculating the dispersion parameter based on the published summary results.

  17. C-MAC compared with direct laryngoscopy for intubation in patients with cervical spine immobilization: A manikin trial.

    Science.gov (United States)

    Smereka, Jacek; Ladny, Jerzy R; Naylor, Amanda; Ruetzler, Kurt; Szarpak, Lukasz

    2017-08-01

    The aim of this study was to compare C-MAC videolaryngoscopy with direct laryngoscopy for intubation in simulated cervical spine immobilization conditions. The study was designed as a prospective randomized crossover manikin trial. 70 paramedics with immobilization (Scenario A); manual inline cervical immobilization (Scenario B); cervical immobilization using cervical extraction collar (Scenario C). Scenario A: Nearly all participants performed successful intubations with both MAC and C-MAC on the first attempt (95.7% MAC vs. 100% C-MAC), with similar intubation times (16.5s MAC vs. 18s C-MAC). Scenario B: The results with C-MAC were significantly better than those with MAC (pimmobilization. Copyright © 2017 Elsevier Inc. All rights reserved.

  18. Trial of labor compared to repeat cesarean section in women with no other risk factors than a prior cesarean delivery

    DEFF Research Database (Denmark)

    Studsgaard, Anne; Skorstengaard, Malene; Glavind, Julie

    2013-01-01

    OBJECTIVE: To compare outcomes with trial of labor after cesarean (TOLAC) or elective repeat cesarean delivery on maternal request (ERCD-MR). DESIGN: Prospective cohort study. SETTING: Danish university hospital. POPULATION: Women with TOLAC (n = 1161) and women with ERCD-MR (n = 622) between 2003...... and 2010. Exclusion criteria were diabetes, two prior cesarean sections, index cesarean at a different hospital, a delivery after the index cesarean, twin gestation, gestational age ... registration of the deliveries. MAIN OUTCOME MEASURES: Adverse neonatal outcomes, risk factors for emergency cesarean, and uterine rupture in case of TOLAC. RESULTS: TOLAC was associated with an increased risk of neonatal depression [odds ratio (OR) 3.6, 95% confidence interval (CI) 1.1-19.1] and neonatal...

  19. Randomized clinical trial comparing affect regulation and supportive group therapies for victimization-related PTSD with incarcerated women.

    Science.gov (United States)

    Ford, Julian D; Chang, Rocío; Levine, Joan; Zhang, Wanli

    2013-06-01

    Traumatic victimization and associated problems with posttraumatic stress disorder (PTSD) and affect dysregulation are prevalent among incarcerated women, but there is limited evidence to support psychotherapeutic interventions for these problems in this underserved population. A group psychotherapy designed to enhance affect regulation without trauma memory processing-Trauma Affect Regulation: Guide for Education and Therapy (TARGET)-was compared to a supportive group therapy (SGT) in a randomized clinical trial with 72 incarcerated women with full or partial PTSD. Both interventions achieved statistically significant reductions in PTSD and associated symptom severity and increased self-efficacy. Dropout rates for both interventions were low (women's ability to achieve affective resolution (forgiveness) while also reducing their victimization-related PTSD and associated symptoms. Experiential-focused supportive group therapy also may reduce victimization-related PTSD and associated symptoms. Both group therapy approaches warrant further study with this vulnerable population. Copyright © 2012. Published by Elsevier Ltd.

  20. Apnea after awake-regional and general anesthesia in infants: The General Anesthesia compared to Spinal anesthesia (GAS) study: comparing apnea and neurodevelopmental outcomes, a randomized controlled trial

    Science.gov (United States)

    Davidson, Andrew J.; Morton, Neil S.; Arnup, Sarah J.; de Graaff, Jurgen C.; Disma, Nicola; Withington, Davinia E.; Frawley, Geoff; Hunt, Rodney W.; Hardy, Pollyanna; Khotcholava, Magda; von Ungern Sternberg, Britta S.; Wilton, Niall; Tuo, Pietro; Salvo, Ida; Ormond, Gillian; Stargatt, Robyn; Locatelli, Bruno Guido; McCann, Mary Ellen

    2015-01-01

    Background Post-operative apnea is a complication in young infants. Awake-regional anesthesia (RA) may reduce the risk; however the evidence is weak. The General Anesthesia compared to Spinal anesthesia (GAS) study is a randomized, controlled, trial designed to assess the influence of general anesthesia (GA) on neurodevelopment. A secondary aim is to compare rates of apnea after anesthesia. Methods Infants ≤ 60 weeks postmenstrual age scheduled for inguinal herniorraphy were randomized to RA or GA. Exclusion criteria included risk factors for adverse neurodevelopmental outcome and infants born < 26 weeks’ gestation. The primary outcome of this analysis was any observed apnea up to 12 hours post-operatively. Apnea assessment was unblinded. Results 363 patients were assigned to RA and 359 to GA. Overall the incidence of apnea (0 to 12 hours) was similar between arms (3% in RA and 4% in GA arms, Odds Ratio (OR) 0.63, 95% Confidence Intervals (CI): 0.31 to 1.30, P=0.2133), however the incidence of early apnea (0 to 30 minutes) was lower in the RA arm (1% versus 3%, OR 0.20, 95%CI: 0.05 to 0.91, P=0.0367). The incidence of late apnea (30 minutes to 12 hours) was 2% in both RA and GA arms (OR 1.17, 95%CI: 0.41 to 3.33, P=0.7688). The strongest predictor of apnea was prematurity (OR 21.87, 95% CI 4.38 to 109.24) and 96% of infants with apnea were premature. Conclusions RA in infants undergoing inguinal herniorraphy reduces apnea in the early post-operative period. Cardio-respiratory monitoring should be used for all ex-premature infants. PMID:26001033

  1. Apnea after Awake Regional and General Anesthesia in Infants: The General Anesthesia Compared to Spinal Anesthesia Study--Comparing Apnea and Neurodevelopmental Outcomes, a Randomized Controlled Trial.

    Science.gov (United States)

    Davidson, Andrew J; Morton, Neil S; Arnup, Sarah J; de Graaff, Jurgen C; Disma, Nicola; Withington, Davinia E; Frawley, Geoff; Hunt, Rodney W; Hardy, Pollyanna; Khotcholava, Magda; von Ungern Sternberg, Britta S; Wilton, Niall; Tuo, Pietro; Salvo, Ida; Ormond, Gillian; Stargatt, Robyn; Locatelli, Bruno Guido; McCann, Mary Ellen

    2015-07-01

    Postoperative apnea is a complication in young infants. Awake regional anesthesia (RA) may reduce the risk; however, the evidence is weak. The General Anesthesia compared to Spinal anesthesia study is a randomized, controlled trial designed to assess the influence of general anesthesia (GA) on neurodevelopment. A secondary aim is to compare rates of apnea after anesthesia. Infants aged 60 weeks or younger, postmenstrual age scheduled for inguinal herniorrhaphy, were randomized to RA or GA. Exclusion criteria included risk factors for adverse neurodevelopmental outcome and infants born less than 26 weeks gestation. The primary outcome of this analysis was any observed apnea up to 12 h postoperatively. Apnea assessment was unblinded. Three hundred sixty-three patients were assigned to RA and 359 to GA. Overall, the incidence of apnea (0 to 12 h) was similar between arms (3% in RA and 4% in GA arms; odds ratio [OR], 0.63; 95% CI, 0.31 to 1.30, P = 0.2133); however, the incidence of early apnea (0 to 30 min) was lower in the RA arm (1 vs. 3%; OR, 0.20; 95% CI, 0.05 to 0.91; P = 0.0367). The incidence of late apnea (30 min to 12 h) was 2% in both RA and GA arms (OR, 1.17; 95% CI, 0.41 to 3.33; P = 0.7688). The strongest predictor of apnea was prematurity (OR, 21.87; 95% CI, 4.38 to 109.24), and 96% of infants with apnea were premature. RA in infants undergoing inguinal herniorrhaphy reduces apnea in the early postoperative period. Cardiorespiratory monitoring should be used for all ex-premature infants.

  2. Clinical trial comparing autogenous fascia lata sling and Gore-Tex suspension in bilateral congenital ptosis

    Directory of Open Access Journals (Sweden)

    Elsamkary MA

    2016-03-01

    Full Text Available Mahmoud Ahmed Elsamkary,1 Maged Maher Salib Roshdy1,2 1Ophthalmology Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt; 2Pediatric Ophthalmology Department, Al Watany Eye Hospital, Cairo, Egypt Purpose: To study the effect of autogenous fascia lata sling (AFLS versus Gore-Tex suspension (GTS regarding the functional and aesthetic outcomes in patients with bilateral congenital ptosis. Patients and methods: A prospective comparative randomized single-center study enrolled 110 patients with bilateral congenital ptosis. One group (n=55 underwent AFLS and the second group (n=55 underwent GTS. Exclusion criteria were good levator function, absent Bell’s phenomenon, and abnormal ocular motility. Follow-up period was 2 years. Functional outcome was measured from digital photos by analysis of upper eyelid margin position relative to the superior limbus and classified as very good (<3 mm, good (3–5 mm, poor (>5 mm, and recurrent. Aesthetic outcome was assessed in terms of lid contour, symmetry of eyelid height, and lid crease presence. Complications were also reported. Results: Failure rate (recurrence and complications was less in AFLS (P=0.035. Symmetrical lid height and good contour were more frequently attained by AFLS (P=0.007 and 0.047, respectively. However, the frequency of very good, good, poor, recurrence, lagopthalmos, ectropion, infection, and formed lid crease individually showed no statistically significant difference (P=0.252, 0.482, 1, 0.489, 0.438, 1, 0.618, and 0.506, respectively. Conclusion: AFLS is a better choice in surgery for patients with bilateral congenital ptosis because it has fewer complications and a lesser recurrence rate than GTS. Keywords: ptosis surgery, surgical outcomes, ptosis recurrence, lagophthalmos

  3. HALF-DOSE DEPOT TRIPTORELIN COMPARABLE TO REDUCED DAILY BUSERELIN: A RANDOMIZED CLINICAL TRIAL

    Directory of Open Access Journals (Sweden)

    L. Safdarian

    2007-09-01

    Full Text Available Pituitary suppression by depot GnRH agonist may be excessive for ovarian stimulation. This study compares the efficacy of a single half-dose depot triptorelin and reduced-dose daily buserelin in a long protocol ICSI/ET. METHODS: A total of 182 patients were randomized into two groups using sealed envelopes. Pituitary desensitization was obtained in group 1 (91 patients with half-dose (1.87 mg depot triptorelin in the mid-luteal phase of their menstrual cycle, and in group 2 (91 patients with standard daily dose (0.5 mg buserelin, which was then reduced to 0.25 mg at the start of human menopausal gonadotropin (HMG stimulation. RESULTS: No significant differences were found among those who received HCG in terms of clinical pregnancy rate (34.4% in both groups, implantation rate (14.8% in group 1 versus 11.1% in group 2, fertilization rate (93.3 versus 95.6%, poor response rate (11.1 versus 6.7%, and miscarriage rate (11.1 versus 7.8%. No significant differences were seen in number of HMG ampoules used, follicles at HCG administration, and oocytes retrieved. The number of days of stimulation was significantly reduced in group 2 (11.2 +/- 1.8 in group 1 versus 10.6 +/- 1.9, p = 0.030. CONCLUSION: A half-dose of depot triptorelin can be successfully used in ovarian stimulation instead of reduced-dose daily buserelin, with more patient comfort and reduced stress and cost of injections.

  4. Randomized trial comparing rabeprazole- versus lansoprazole-based Helicobacter pylori eradication regimens.

    Science.gov (United States)

    Liu, Meng-Kwan; Wu, I-Chen; Lu, Chien-Yu; Kuo, Chao-Hung; Yu, Fang-Jung; Liu, Chung-Jung; Hsu, Ping-I; Hsu, Wen-Hung; Su, Yu-Chung; Chen, Angela; Wu, Deng-Chyang; Kuo, Fu-Chen; Chen, Jyh-Jou

    2013-07-01

    Different types of proton pump inhibitor (PPI)-based triple therapies could result in different Helicobacter pylori eradication rates. This study aimed to compare the efficacy and safety of rabeprazole- and lansoprazole-based triple therapies in primary treatment of H. pylori infection. From September 2005 to July 2008, 426 H. pylori-infected patients were randomly assigned to receive a 7-day eradication therapy with either rabeprazole 20mgbid (RAC group, n=222) or lansoprazole 30mgbid (LAC group, n=228) in combination with amoxicillin 1gbid and clarithromycin 500mgbid. The patients received follow-up esophagogastroduodenoscopy (EGD) and/or (13)C-urea breath test 12-16 weeks later to define H. pylori status. Their personal and medical history, compliance and side effects were obtained by using a standardized questionnaire. Intention-to-treat analysis revealed that the eradication rate was 87.84% in the RAC group and 85.96% in the LAC group (p=0.56). All patients returned for assessment of compliance (100% in the LAC group vs. 99.50% in the RAC group; p=0.32) and adverse events (7.20% in the RAC group vs. 5.70% in the LAC group, p=0.51). Univariate analysis suggested that patients with nonsteroid anti-inflammatory agent (NSAID) use had lower eradication rates than those without (76.71% vs. 88.74%; p=0.006). Our results showed that efficacy and safety were similar in rabeprazole- and lansoprazole-based primary therapies. The influence of NSAID usage on H. pylori eradication needs to be further investigated. Copyright © 2012. Published by Elsevier B.V.

  5. Randomized trial comparing rabeprazole- versus lansoprazole-based Helicobacter pylori eradication regimens

    Directory of Open Access Journals (Sweden)

    Meng-Kwan Liu

    2013-07-01

    Full Text Available Different types of proton pump inhibitor (PPI-based triple therapies could result in different Helicobacter pylori eradication rates. This study aimed to compare the efficacy and safety of rabeprazole- and lansoprazole-based triple therapies in primary treatment of H. pylori infection. From September 2005 to July 2008, 426 H. pylori-infected patients were randomly assigned to receive a 7-day eradication therapy with either rabeprazole 20 mg bid (RAC group, n=222 or lansoprazole 30 mg bid (LAC group, n=228 in combination with amoxicillin 1 g bid and clarithromycin 500 mg bid. The patients received follow-up esophagogastroduodenoscopy (EGD and/or 13C-urea breath test 12–16 weeks later to define H. pylori status. Their personal and medical history, compliance and side effects were obtained by using a standardized questionnaire. Intention-to-treat analysis revealed that the eradication rate was 87.84% in the RAC group and 85.96% in the LAC group (p=0.56. All patients returned for assessment of compliance (100% in the LAC group vs. 99.50% in the RAC group; p=0.32 and adverse events (7.20% in the RAC group vs. 5.70% in the LAC group, p=0.51. Univariate analysis suggested that patients with nonsteroid anti-inflammatory agent (NSAID use had lower eradication rates than those without (76.71% vs. 88.74%; p=0.006. Our results showed that efficacy and safety were similar in rabeprazole- and lansoprazole-based primary therapies. The influence of NSAID usage on H. pylori eradication needs to be further investigated.

  6. Prospectively randomized clinical trial to compare in situ and reversed saphenous vein grafts for femoropopliteal bypass.

    Science.gov (United States)

    Harris, P L; How, T V; Jones, D R

    1987-04-01

    Two hundred and fifteen femoropopliteal bypass procedures using autologous saphenous vein grafts were randomly allocated to either the reversed or in situ technique. Eleven veins (5 per cent) were rejected at operation on the basis of their small size, nine in the reversed group and two in the in situ group, and there were two (2 per cent) perioperative deaths in each group, leaving 102 reversed and 98 in situ grafts for further study. The cumulative patency at 3 years of the reversed grafts was 77 per cent and that of the in situ grafts was 68 per cent (n.s.). The patency of all grafts was affected adversely by small veins (P less than 0.005), long grafts (P less than 0.05), low volume of blood flow in the grafts (P less than 0.001) and poor run-off (P less than 0.05). These factors influenced the outcome of the in situ and reversed operations to a similar degree and there was no statistically significant difference between them within any subgroup. The mean compliance of the in situ grafts measured 3 months or more after operation with an ultrasonic echo-tracking system was 0.024 +/- 0.01 per cent/mmHg (+/- s.d.) compared with 0.017 +/- 0.01 per cent/mmHg for the reversed grafts (t = 2.43, P less than 0.02). The incidence of fibrous stricture formation as shown by intravenous digital subtraction angiography was 29 per cent in both the reversed and the in situ grafts. The results of the study to date indicate that reversed and in situ vein grafts are equally effective for femoropopliteal bypass.

  7. A randomized clinical trial to compare three methods of orthodontic space closure.

    Science.gov (United States)

    Dixon, V; Read, M J F; O'Brien, K D; Worthington, H V; Mandall, N A

    2002-03-01

    To compare the rates of orthodontic space closure for: Active ligatures, polyurethane powerchain (Rocky Mountain Orthodontics, RMO Europe, Parc d'Innovation, Rue Geiler de Kaysersberg, 67400 Illkirch-Graffenstaden, Strasbourg, France) and nickel titanium springs. Patients entering the space closure phase of fixed orthodontic treatment attending six orthodontic providers. Twelve patients received active ligatures (48 quadrants), 10 patients received powerchain (40 quadrants) and 11 patients, nickel-titanium springs (44 quadrants). Patients were randomly allocated for treatment with active ligatures, powerchain or nickel titanium springs. Upper and lower study models were collected at the start of space closure (T(o)) and 4 months later (T(1)). We recorded whether the patient wore Class II or Class III elastics. Space present in all four quadrants was measured, by a calibrated examiner, using Vernier callipers at T(o) and T(1.) The rate of space closure, in millimetres per month (4 weeks) and a 4-monthly rate, was then calculated. Examiner reliability was assessed at least 2 weeks later. Mean rates of space closure were 0.35 mm/month for active ligatures, 0.58 mm/month for powerchain, and 0.81 mm/month for NiTi springs. No statistically significant differences were found between any methods with the exception of NiTi springs showing more rapid space closure than active ligatures (P space closure. NiTi springs gave the most rapid rate of space closure and may be considered the treatment of choice. However, powerchain provides a cheaper treatment option that is as effective. The use of inter-arch elastics does not appear to influence rate of space closure.

  8. Polyetheretherketone (PEEK) Spacers for Anterior Cervical Fusion: A Retrospective Comparative Effectiveness Clinical Trial.

    Science.gov (United States)

    Lemcke, Johannes; Al-Zain, Ferass; Meier, Ullrich; Suess, Olaf

    2011-01-01

    Anterior cervical decompression and fusion (ACDF) is the standard surgical treatment for radiculopathy and myelopathy. Polyetheretherketone (PEEK) has an elasticity similar to bone and thus appears well suited for use as the implant in ACDF procedures. The aim of this study is to examine the clinical and radiographic outcome of patients treated with standing alone PEEK spacers without bone morphogenic protein (BMP) or plating and to examine the influence of the different design of the two spacers on the rate of subsidence and dislocation. This retrospective comparative study reviewed 335 patients treated by ACDF in a specialized urban hospital for radiculopathy or myelopathy due to degenerative pathologies. The Intromed PEEK spacer was used in 181 patients from 3/2002 to 11/2004, and the AMT SHELL spacer was implanted in 154 patients from 4/2004 to 12/2007. The follow-up rate was 100% at three months post-op and 82.7% (277 patients) at one year. The patients were assessed with the Japanese Orthopedic Association (JOA) questionnaire and radiographically. At the one-year follow-up there were 118/277 patients with an excellent clinical outcome on the JOA, 112/277 with a good outcome, 20/277 with a fair outcome, and 27/277 with a poor outcome. Subsidence was observed in 13.3% of patients with the Intromed spacer vs 8.4% of the patients with the AMT SHELL. Dislocation of the spacer was observed in 10 of the 181 patients with Intromed spacers but in none of the 154 patients with Shell spacers. The study demonstrates that ACDF with standing alone PEEK cages leads to excellent and good clinical outcomes. The differences we observed in the subsidence rate between the two spacers were not significant and cannot be related to a single design feature of the spacers.

  9. Dancing for Parkinson Disease: A Randomized Trial of Irish Set Dancing Compared With Usual Care.

    Science.gov (United States)

    Shanahan, Joanne; Morris, Meg E; Bhriain, Orfhlaith Ni; Volpe, Daniele; Lynch, Tim; Clifford, Amanda M

    2017-09-01

    To examine the feasibility of a randomized controlled study design and to explore the benefits of a set dancing intervention compared with usual care. Randomized controlled design, with participants randomized to Irish set dance classes or a usual care group. Community based. Individuals with idiopathic Parkinson disease (PD) (N=90). The dance group attended a 1.5-hour dancing class each week for 10 weeks and undertook a home dance program for 20 minutes, 3 times per week. The usual care group continued with their usual care and daily activities. The primary outcome was feasibility, determined by recruitment rates, success of randomization and allocation procedures, attrition, adherence, safety, willingness of participants to be randomized, resource availability, and cost. Secondary outcomes were motor function (motor section of the Unified Parkinson's Disease Rating Scale), quality of life (Parkinson's Disease Questionnaire-39), functional endurance (6-min walk test), and balance (mini-BESTest). Ninety participants were randomized (45 per group). There were no adverse effects or resource constraints. Although adherence to the dancing program was 93.5%, there was >40% attrition in each group. Postintervention, the dance group had greater nonsignificant gains in quality of life than the usual care group. There was a meaningful deterioration in endurance in the usual care group. There were no meaningful changes in other outcomes. The exit questionnaire showed participants enjoyed the classes and would like to continue participation. For people with mild to moderately severe PD, set dancing is feasible and enjoyable and may improve quality of life. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  10. Results of a clinical trial comparing conservative and modified radical mastectomy for early breast cancer

    International Nuclear Information System (INIS)

    Du Xianghui; Wang Yuezhen; Wu Lie; Zhu Yuan; Yang Hongjian; Zou Dehong

    2005-01-01

    Objective: The influence of conservative mastectomy plus postoperative radiation (CM + RT) in local control, distant failure, cosmetic and psychological outcome for early stage breast cancer was evaluated comparing with modified radical mastectomy. Methods: Between January 1998 and December 2003, 68 early stage breast cancer patients underwent CM + RT. During the save period, 76 similar patients were treated by modified radical mastectomy (MRM + RT). The cosmetic results evaluated as 'excellent', 'fair' or 'poor' using specific guide lines together with their psychological changes. Sex life and marital stability were also recorded. All patients were female with median age of 44.5 years (range, 28-62 years). Guidelines for patient selection reported by National Breast Cancer Cooperative Group was adhered to. In general, CM consisted of wide local excision with the breast conserved and postoperative radiotherapy to the entire breast with tangential fields followed by a boost to the tumor bed. All patients also received adjuvant chemotherapy with CAF. Patients with positive ER or PR assay results received tamoxifen for 5 years. In the 76 MRM + RT patients, the post operative radiotherapy and chemotherapy were given as clinically indicated. Results: There was no failure locally in all. In CM + RT group, the cause of failure was bone metastasis in 1 and mutiple metastasis in 2. In the MRM + RT group, the cause of failure was bone metastasis in 2, brain metastasis in 1 and mutiple metastases in 1. The cosmetic scores were 91.2% excellent, 5.6% fair and 2.9% poor. Conclusions: Breast preservation by conservative mastectomy is preferable to mastectomy in appropriately selected patients as it provides equivalent survival but giving good cosmetic results. (authors)

  11. A randomized equivalence trial comparing the i-gel and laryngeal mask airway Supreme in children.

    Science.gov (United States)

    Jagannathan, Narasimhan; Sommers, Katherine; Sohn, Lisa E; Sawardekar, Amod; Shah, Ravi D; Mukherji, Isabella I; Miller, Steven; Voronov, Polina; Seraphin, Sally

    2013-02-01

    The laryngeal mask airway Supreme (Supreme) is a new single-use supraglottic device with gastric access capability now available in all sizes for children. To compare the i-gel with the Supreme in children for routine airway maintenance. One hundred and seventy children, aged 3 months to 11 years, 5-50 kg in weight, were randomly assigned to receive either the i-gel or the Supreme. The primary outcome measured was airway leak pressure. Secondary outcomes included the following: ease and time for insertion, insertion success rate, fiberoptic grade of view, ease of gastric tube placement, number of airway manipulations, quality of airway during anesthetic maintenance, and complications. A total of 168 patients were assessed for the outcomes. The median (IQR [range]) airway leak pressure for the i-gel was higher than with the Supreme, 20 (18-25 [9-40]) cm H(2)O vs 17 (14-22 [10-40]) cm H(2)O, respectively (P = 0.001). There were no differences in the time for device insertion, fiberoptic grade of view, quality of airway, and complications. Median (IQR[range]) time of successful insertion of a gastric tube was faster with the Supreme, 12 (9.2-14.3 [5.2-44.2]) s than with the i-gel, 14 (11.9-19 [6.9-75]) s; P = 0.01. The number of airway manipulations during placement was higher with the i-gel than with the laryngeal mask airway Supreme (12 vs 13 patients), P = 0.02. In infants and children, when a single-use supraglottic device with gastric access capabilities is required, the i-gel demonstrated higher airway leak pressures and can be a useful alternative to the Supreme. © 2012 Blackwell Publishing Ltd.

  12. Calorie shifting diet versus calorie restriction diet: a comparative clinical trial study.

    Science.gov (United States)

    Davoodi, Sayed Hossein; Ajami, Marjan; Ayatollahi, Seyyed Abdulmajid; Dowlatshahi, Kamran; Javedan, Gholamali; Pazoki-Toroudi, Hamid Reza

    2014-04-01

    Finding new tolerable methods in weight loss has largely been an issue of interest for specialists. Present study compared a novel method of calorie shifting diet (CSD) with classic calorie restriction (CR) on weight loss in overweight and obese subjects. Seventy-four subjects (body mass index ≥25; 37) were randomized to 4 weeks control diet, 6 weeks CSD or CR diets, and 4 weeks follow-up period. CSD consisted of three phases each lasts for 2 weeks, 11 days calorie restriction which included four meals every day, and 4 h fasting between meals follow with 3 days self-selecting diet. CR subjects receive determined low calorie diet. Anthropometric and metabolic measures were assessed at different time points in the study. Four weeks after treatment, significant weight, and fat loss started (6.02 and 5.15 kg) and continued for 1 month of follow-up (5.24 and 4.3 kg), which was correlated to the restricted energy intake (P < 0.05). During three CSD phases, resting metabolic rate tended to remain unchanged. The decrease in plasma glucose, total cholesterol, and triacylglycerol were greater among subjects on the CSD diet (P < 0.05). Feeling of hunger decreased and satisfaction increased among those on the CSD diet after 4 weeks (P < 0.05). The CSD diet was associated with a greater improvement in some anthropometric measures, Adherence was better among CSD subjects. Longer and larger studies are required to determine the long-term safety and efficacy of CSD diet.

  13. Sublingual vitamin B12 compared to intramuscular injection in patients with type 2 diabetes treated with metformin: a randomised trial.

    Science.gov (United States)

    Parry-Strong, Amber; Langdana, Fali; Haeusler, Sylvan; Weatherall, Mark; Krebs, Jeremy

    2016-06-10

    MAIM: To compare a single 1mg intramuscular hydroxocobalamin injection with a 3-month course of 1mg/day sublingual methylcobalamin supplements on serum vitamin B12 concentrations in participants withtype 2 diabetes treated with metformin. Participants on metformin treatment with vitamin B12 concentrations below 220pmol/L were recruited through hospital diabetes clinics and primary care practices. They were randomised to receive either the injection or sublingual treatment. The primary outcome was serum vitamin B12 level after 3 months adjusted for baseline assessed by analysis of covariance (ANCOVA). The trial was registered on the Australia New Zealand Clinical Trial registry (ACTRN12612001108808). A total of 34 participants were randomised; 19 to the tablet, and 15 to the injection. The mean (SD) age, duration of diabetes, and duration of metformin use were, 64.2 (7.3) years, 13.7 (6.4) years, and 11.6 (5.0) years, respectively. After 3 months, the mean (SD) vitamin B12 was 372.1 (103.3) pmol/L in the tablet group (n=19) compared to 251.7 (106.8) pmol/L in the injection group (n=15), ANCOVA estimated difference -119.4 (95% CI -191.2 to -47.6), p=0.002. After 6 months, the mean (SD) serum B12 was 258.8 (58.7) pmol/L in the tablet group (n=17) and 241.9 (40.1) pmol/L in the injection group (n=15); ANCOVA estimated difference -15.2 (95% CI -50.3 to 19.8), p=0.38. Higher metformin dose was associated with lower serum B12 at 3 months, but not at baseline or 6 months. Decreased serum vitamin B12 level in patients with type 2 diabetes who are treated with metformin can be corrected through treatment with either hydroxocobalamin injections or methylcobalamin sublingual supplements.

  14. Born not breathing: A randomised trial comparing two self-inflating bag-masks during newborn resuscitation in Tanzania.

    Science.gov (United States)

    Thallinger, Monica; Ersdal, Hege Langli; Francis, Fortunata; Yeconia, Anita; Mduma, Estomih; Kidanto, Hussein; Linde, Jørgen Erland; Eilevstjønn, Joar; Gunnes, Nina; Størdal, Ketil

    2017-07-01

    Effective ventilation is crucial to save non-breathing newborns. We compared standard equipment for newborn resuscitation to a new Upright bag, in an area with high neonatal mortality. Newborns requiring resuscitation at Haydom Lutheran Hospital, Tanzania, were ventilated with 230ml standard or 320ml Upright bag-mask by weekly non-blinded block randomisation. A Laerdal Newborn Resuscitation Monitor collected ventilation data through a flow sensor between mask and bag and heart rate with electrocardiography electrodes. Primary outcome was expiratory tidal volume per birth weight. Of 6110 babies born, 136 randomised to standard bag-mask and 192 to Upright, both groups had similar birth weight, gestational age, Apgar scores, gender, and mode of delivery. Compared to standard bag-mask, Upright gave higher median expiratory tidal volume (8.6ml/kg (IQR: 3.5-13.8) vs. 10.0ml/kg (IQR: 4.3-16.8) difference ratio 1.29, 95%CI 1.05, 1.58, p=0.014)), increased mean airway and peak inspiratory pressures, and higher early expired CO 2 (median at 20s 4.2% vs. 3.2%, p=0.0099). Clinical outcome 30min post-delivery was normal in 44% with standard versus 57% with Upright (p=0.016), but similar at 24h. Upright provided higher expired tidal volume, MAP, PIP and early ECO 2 than the standard bag. Clinical outcome differed at 30min, but not at 24h. Larger volume of Upright than standard bag can be an important factor. The results are relevant for low- and high-income settings as ventilatory and heart rate parameters during resuscitation of newborns are rarely reported. Trial registered at www.ClinicalTrials.gov, NCT01869582. Copyright © 2017 Elsevier B.V. All rights reserved.

  15. No sustained attention differences in a longitudinal randomized trial comparing mindfulness based stress reduction versus active control.

    Directory of Open Access Journals (Sweden)

    Donal G MacCoon

    Full Text Available Mindfulness Based Stress Reduction (MBSR is a secular form of meditation training. The vast majority of the extant literature investigating the health effects of mindfulness interventions relies on wait-list control comparisons. Previous studies have found that meditation training over several months is associated with improvements in cognitive control and attention.We used a visual continuous performance task (CPT to test the effects of eight weeks of mindfulness training on sustained attention by comparing MBSR to the Health Enhancement Program (HEP, a structurally equivalent, active control condition in a randomized, longitudinal design (ClinicalTrials.gov, NCT01301105 focusing on a non-clinical population typical of MBSR participants. Researchers were blind to group assignment. 63 community participants were randomized to either MBSR (n = 31 or HEP (n = 32. CPT analyses were conducted on 29 MBSR participants and 25 HEP participants. We predicted that MBSR would improve visual discrimination ability and sustained attention over time on the CPT compared to HEP, with more home practice associated with greater improvements. Our hypotheses were not confirmed but we did find some evidence for improved visual discrimination similar to effects in partial replication of other research. Our study had sufficient power to demonstrate that intervention groups do not differ in their improvement over time in sustained attention performance. One of our primary predictions concerning the effects of intervention on attentional fatigue was significant but not interpretable.Attentional sensitivity is not affected by mindfulness practice as taught in MBSR, but it is unclear whether mindfulness might positively affect another aspect of attention, vigilance. These results also highlight the relevant procedural modifications required by future research to correctly investigate the role of sustained attention in similar samples.ClinicalTrials.gov, NCT

  16. Meta-analysis of randomized, controlled trials comparing griseofulvin and terbinafine in the treatment of tinea capitis.

    Science.gov (United States)

    Tey, Hong Liang; Tan, Andy Soon Leong; Chan, Yuin Chew

    2011-04-01

    Griseofulvin has been the standard treatment for tinea capitis but newer antifungal agents, particularly terbinafine, are increasingly being used because of their shorter duration of treatment and more consistent absorption rates. We sought to compare the efficacy of oral griseofulvin and oral terbinafine in the treatment of tinea capitis. A search of MEDLINE, EMBASE, Cochrane Central Register of Clinical Trials, and the Cochrane Skin Group Ongoing Skin Trials Register was performed up to January 2010 for randomized controlled trials comparing griseofulvin and terbinafine in the treatment of tinea capitis in immunocompetent patients. The primary outcome measure was the complete cure rate. The mycological and clinical cure rates and adverse effects were secondary outcome measures. Pooling of treatment effect was accomplished using a random effects model and the I(2) test was used to check for heterogeneity among the studies. Seven studies involving 2163 subjects were included. There was no significant difference in efficacy between griseofulvin (mean duration of treatment 8 weeks, range 6-12 weeks) and terbinafine (mean duration of treatment 4 weeks, range 2-6 weeks); odds ratio = 1.22 favoring terbinafine (95% confidence interval [CI] = 0.785-1.919; P = .37). In the pooled analysis of 5 studies in which Trichophyton species were the predominant (≥65%) pathogenic dermatophyte, terbinafine showed a trend toward greater efficacy (odds ratio 1.49; 95% CI = 0.975-2.277; P = .065). Subgroup analysis revealed that terbinafine was more efficacious than griseofulvin in treating Trichophyton species (1.616; 95% CI = 1.274-2.051; P griseofulvin was more efficacious than terbinafine in treating Microsporum species (0.408; 95% CI = 0.254-0.656; P griseofulvin and terbinafine demonstrated good safety profiles in the studies. Data on efficacy of griseofulvin and terbinafine for separate groups of Trichophyton and Microsporum species were not available from every study. In the

  17. Spirulina platensis versus silymarin in the treatment of chronic hepatitis C virus infection. A pilot randomized, comparative clinical trial

    Directory of Open Access Journals (Sweden)

    Yakoot Mostafa

    2012-04-01

    Full Text Available Abstract Background Spirulina platensis, a cynobacterium used frequently as a dietary supplement had been found to exhibit many immune-stimulating and antiviral activities. It had been found to activate macrophages, NK cells, T cells, B cells, and to stimulate the production of Interferon gamma (IFN-γ and other cytokines. Natural substances isolated from Spirulina platensis had been found to be potent inhibitors against several enveloped viruses by blocking viral absorption/penetration and some replication stages of progeny viruses after penetration into cells. We aimed to study whether this dietary supplement possesses any therapeutically feasible activity worthy of further larger controlled clinical evaluation. Methods Sixty six patients with chronic hepatitis C virus infection and eligible for inclusion had been randomized to either Spirulina or Silymarin treated groups for a period of six months treatment. The two groups were followed up and blindly compared for early (after 3 months and end of 6 months treatment virological response. The effects of both treatments on each of alanine aminotransferase (ALT, Chronic Liver Disease Questionnaire scores (CLDQ, Arizona Sexual Experience Scale scores (ASEX and the occurrence of any attributable adverse events were also compared. Results Among the 30 patients who had been treated with Spirulina and completed the 6 months protocol, 4 patients (13.3% had a complete end of treatment virological response and 2 patients (6.7% had a partial end of treatment response defined as significant decrease of virus load of at least 2-logs10. Though the proportion of responders in Spirulina group was greater than in the Silymarin group, the difference was not statistically significant at the end of both 6 months (p = 0.12 and 3 months treatment (p = 0.22 by Exact test. Alanine aminotransferase as well as CLDQ and ASEX scores were found to be more significantly improved in Spirulina than in Silymarin treated group

  18. Comparative effectiveness of post-discharge interventions for hospitalized smokers: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Japuntich, Sandra J; Regan, Susan; Viana, Joseph; Tymoszczuk, Justyna; Reyen, Michele; Levy, Douglas E; Singer, Daniel E; Park, Elyse R; Chang, Yuchiao; Rigotti, Nancy A

    2012-08-01

    A hospital admission offers smokers an opportunity to quit. Smoking cessation counseling provided in the hospital is effective, but only if it continues for more than one month after discharge. Providing smoking cessation medication at discharge may add benefit to counseling. A major barrier to translating this research into clinical practice is sustaining treatment during the transition to outpatient care. An evidence-based, practical, cost-effective model that facilitates the continuation of tobacco treatment after discharge is needed. This paper describes the design of a comparative effectiveness trial testing a hospital-initiated intervention against standard care. A two-arm randomized controlled trial compares the effectiveness of standard post-discharge care with a multi-component smoking cessation intervention provided for three months after discharge. Current smokers admitted to Massachusetts General Hospital who receive bedside smoking cessation counseling, intend to quit after discharge and are willing to consider smoking cessation medication are eligible. Study participants are recruited following the hospital counseling visit and randomly assigned to receive Standard Care or Extended Care after hospital discharge. Standard Care includes a recommendation for a smoking cessation medication and information about community resources. Extended Care includes up to three months of free FDA-approved smoking cessation medication and five proactive computerized telephone calls that use interactive voice response technology to provide tailored motivational messages, offer additional live telephone counseling calls from a smoking cessation counselor, and facilitate medication refills. Outcomes are assessed at one, three, and six months after hospital discharge. The primary outcomes are self-reported and validated seven-day point prevalence tobacco abstinence at six months. Other outcomes include short-term and sustained smoking cessation, post-discharge utilization

  19. A randomized controlled trial comparing soft contact lens and rigid gas-permeable lens wearing in infantile nystagmus.

    Science.gov (United States)

    Jayaramachandran, Pavitra; Proudlock, Frank A; Odedra, Nita; Gottlob, Irene; McLean, Rebecca J

    2014-09-01

    To perform the first randomized controlled trial comparing soft contact lens (SCL) with rigid gas-permeable lens (RGPL) wearing in infantile nystagmus (IN), using spectacle wear as a baseline. Randomized, controlled cross-over trial with an intention-to-treat design. A total of 24 participants with IN (12 idiopathic, 12 with albinism). Participants were randomized into 1 of 2 treatment arms receiving the following sequence of treatments (2-3 weeks for each treatment): (A) spectacles, SCL, RGPL, and spectacle wear; or (B) spectacles, RGPL, SCL, and spectacle wear. The main outcome measure was mean intensity of nystagmus at the null region viewing at 1.2 m. Secondary outcome measures included the same measure at 0.4 m viewing and across the horizontal meridian (measured over a ±30° range at 3° intervals) for distance and near. The nystagmus foveation characteristics were similarly assessed over ±30° and at the null region at 1.2 m and 0.4 m viewing. Visual outcome measures included best-corrected visual acuity (BCVA) at 4 m and 0.4 m, gaze-dependent visual acuity (GDVA) (i.e., visual acuity when maintaining gaze angles over a ±30° range at 10° intervals) at 4 m, and reading performance at 0.4 m derived from the Radner reading chart. There were no significant differences between SCL and RGPL wearing for any nystagmus characteristics or compared with spectacle wearing. The BCVA, reading acuity, and critical print size were significantly worse for SCL wearing compared with RGPL and baseline spectacle wear (Pangle of resolution (logMAR) line. Nystagmus was not significantly different during SCL and RGPL wearing in IN, and contact lens wearing does not significantly reduce nystagmus compared with baseline spectacle wearing. The wearing of SCL leads to a small but statistically significant deterioration in visual function compared with both RGPL and spectacle wearing at baseline, although mean effect sizes were not clinically relevant. Copyright © 2014 American

  20. Comparative evaluation of terminalia chebula extract mouthwash and chlorhexidine mouthwash on plaque and gingival inflammation - 4-week randomised control trial.

    Science.gov (United States)

    Gupta, Devanand; Gupta, Rajendra Kumar; Bhaskar, Dara John; Gupta, Vipul

    2015-01-01

    The present study was conducted to assess the effectiveness of Terminalia chebula on plaque and gingival inflammation and compare it with the gold standard chlorhexidine (CHX 0.2%) and distilled water as control (placebo). A double-blind randomised control trial was conducted among undergraduate students who volunteered. They were randomly allocated into three study groups: 1) Terminalia chebula mouthwash (n = 30); 2) chlorhexidine (active control) (n = 30); 3) distilled water (placebo) (n = 30). Assessment was carried out according to plaque score and gingival score. Statistical analysis was carried out to compare the effect of both mouthwashes. ANOVA and post-hoc LSD tests were performed using SPSS version 17 with p ≤ 0.05 considered statistically significant. Our result showed that Terminalia chebula mouthrinse is as effective as chlorhexidine in reducing dental plaque and gingival inflammation. The results demonstrated a significant reduction of gingival bleeding and plaque indices in both groups over a period of 15 and 30 days as compared to the placebo. The results of the present study indicate that Terminalia chebula may prove to be an effective mouthwash. Terminalia chebula extract mouthrinse can be used as an alternative to chlorhexidine mouthrinse as it has similar properties without the side-effects of the latter.

  1. Simulator training to automaticity leads to improved skill transfer compared with traditional proficiency-based training: a randomized controlled trial.

    Science.gov (United States)

    Stefanidis, Dimitrios; Scerbo, Mark W; Montero, Paul N; Acker, Christina E; Smith, Warren D

    2012-01-01

    We hypothesized that novices will perform better in the operating room after simulator training to automaticity compared with traditional proficiency based training (current standard training paradigm). Simulator-acquired skill translates to the operating room, but the skill transfer is incomplete. Secondary task metrics reflect the ability of trainees to multitask (automaticity) and may improve performance assessment on simulators and skill transfer by indicating when learning is complete. Novices (N = 30) were enrolled in an IRB-approved, blinded, randomized, controlled trial. Participants were randomized into an intervention (n = 20) and a control (n = 10) group. The intervention group practiced on the FLS suturing task until they achieved expert levels of time and errors (proficiency), were tested on a live porcine fundoplication model, continued simulator training until they achieved expert levels on a visual spatial secondary task (automaticity) and were retested on the operating room (OR) model. The control group participated only during testing sessions. Performance scores were compared within and between groups during testing sessions. : Intervention group participants achieved proficiency after 54 ± 14 and automaticity after additional 109 ± 57 repetitions. Participants achieved better scores in the OR after automaticity training [345 (range, 0-537)] compared with after proficiency-based training [220 (range, 0-452; P training to automaticity takes more time but is superior to proficiency-based training, as it leads to improved skill acquisition and transfer. Secondary task metrics that reflect trainee automaticity should be implemented during simulator training to improve learning and skill transfer.

  2. Mifepristone and misoprostol compared with misoprostol alone for induction of labor in intrauterine fetal death: A randomized trial.

    Science.gov (United States)

    Chaudhuri, Picklu; Datta, Sutapa

    2015-12-01

    To assess whether mifepristone and misoprostol are more beneficial than misoprostol alone for the induction of labor in women with intrauterine fetal death. A randomized double blind placebo-controlled parallel group superiority trial was conducted. One hundred and ten women who had experienced fetal death at or later than 20 weeks of gestation were randomized by computer-generated random number sequence to receive 200 mg of mifepristone or matched placebo tablets orally. Misoprostol was administered vaginally to women of both groups after 36-48 h. The main outcomes studied were the fetal-placental delivery rate within 24 hours of commencement of the first dose of misoprostol without additional intervention and the induction-delivery interval. Successful delivery occurred significantly more frequently in women who received mifepristone prior to misoprostol than in women who received only misoprostol (92.5% [49/53] compared with 71.2% [37/52] respectively; P = 0.001). The mean induction-delivery interval was also significantly shorter when using mifepristone plus misoprostol than using misoprostol alone (9.8 h, standard deviation, 4.4 compared with 16.3 h standard deviation, 5.7, respectively; P misoprostol significantly improved the rate of successful delivery and shortened the induction-delivery interval in women who had experienced fetal death compared with the use of misoprostol alone. © 2015 Japan Society of Obstetrics and Gynecology.

  3. School playground surfacing and arm fractures in children: a cluster randomized trial comparing sand to wood chip surfaces.

    Directory of Open Access Journals (Sweden)

    Andrew W Howard

    2009-12-01

    Full Text Available The risk of playground injuries, especially fractures, is prevalent in children, and can result in emergency room treatment and hospital admissions. Fall height and surface area are major determinants of playground fall injury risk. The primary objective was to determine if there was a difference in playground upper extremity fracture rates in school playgrounds with wood fibre surfacing versus granite sand surfacing. Secondary objectives were to determine if there were differences in overall playground injury rates or in head injury rates in school playgrounds with wood fibre surfacing compared to school playgrounds with granite sand surfacing.The cluster randomized trial comprised 37 elementary schools in the Toronto District School Board in Toronto, Canada with a total of 15,074 students. Each school received qualified funding for installation of new playground equipment and surfacing. The risk of arm fracture from playground falls onto granitic sand versus onto engineered wood fibre surfaces was compared, with an outcome measure of estimated arm fracture rate per 100,000 student-months. Schools were randomly assigned by computer generated list to receive either a granitic sand or an engineered wood fibre playground surface (Fibar, and were not blinded. Schools were visited to ascertain details of the playground and surface actually installed and to observe the exposure to play and to periodically monitor the depth of the surfacing material. Injury data, including details of circumstance and diagnosis, were collected at each school by a prospective surveillance system with confirmation of injury details through a validated telephone interview with parents and also through collection (with consent of medical reports regarding treated injuries. All schools were recruited together at the beginning of the trial, which is now closed after 2.5 years of injury data collection. Compliant schools included 12 schools randomized to Fibar that installed

  4. Cancer-Related Fatigue and Rehabilitation: A Randomized Controlled Multicenter Trial Comparing Physical Training Combined With Cognitive-Behavioral Therapy With Physical Training Only and With No Intervention

    OpenAIRE

    van Weert, E.; May, A.M.; Korstjens, I.; Post, W.J.; van der Schans, C.P.; van den Borne, B.; Mesters, I.; Ros, W.J.G.; Hoekstra-Weebers, J.E.H.M.

    2010-01-01

    textabstractBackground. Research suggests that cancer rehabilitation reduces fatigue in survivors of cancer. To date, it is unclear what type of rehabilitation is most beneficial. Objective. This randomized controlled trial compared the effect on cancerrelated fatigue of physical training combined with cognitive behavioral therapy with physical training alone and with no intervention. Design. In this multicenter randomized controlled trial, 147 survivors of cancer were randomly assigned to a ...

  5. Randomized Controlled Feasibility Trial of Intranasal Ketamine Compared to Intranasal Fentanyl for Analgesia in Children with Suspected Extremity Fractures.

    Science.gov (United States)

    Reynolds, Stacy L; Bryant, Kathleen K; Studnek, Jonathan R; Hogg, Melanie; Dunn, Connell; Templin, Megan A; Moore, Charity G; Young, James R; Walker, Katherine Rivera; Runyon, Michael S

    2017-12-01

    We compared the tolerability and efficacy of intranasal subdissociative ketamine to intranasal fentanyl for analgesia of children with acute traumatic pain and investigated the feasibility of a larger noninferiority trial that could investigate the potential opioid-sparing effects of intranasal ketamine. This randomized controlled trial compared 1 mg/kg intranasal ketamine to 1.5 μg/kg intranasal fentanyl in children 4 to 17 years old with acute pain from suspected isolated extremity fractures presenting to an urban Level II pediatric trauma center from December 2015 to November 2016. Patients, parents, treating physicians, and outcome assessors were blinded to group allocation. The primary outcome, a tolerability measure, was the frequency of cumulative side effects and adverse events within 60 minutes of drug administration. The secondary outcomes included the difference in mean pain score reduction at 20 minutes, the proportion of patients achieving a clinically significant reduction in pain in 20 minutes, total dose of opioid pain medication in morphine equivalents/kg/hour (excluding study drug) required during the emergency department (ED) stay, and the feasibility of enrolling children presenting to the ED in acute pain into a randomized trial conducted under U.S. regulations. All patients were monitored until 6 hours after their last dose of study drug or until admission to the hospital ward or operating room. Of 629 patients screened, 87 received the study drug and 82 had complete data for the primary outcome (41 patients in each group). The median (interquartile range) age was 8 (6-11) years and 62% were male. Baseline pain scores were similar among patients randomized to receive ketamine (73 ± 26) and fentanyl (69 ± 26; mean difference [95% CI] = 4 [-7 to 15]). The cumulative number of side effects was 2.2 times higher in the ketamine group, but there were no serious adverse events and no patients in either group required intervention. The most

  6. Long-term results of RTOG trial 8911 (USA Intergroup 113): a random assignment trial comparison of chemotherapy followed by surgery compared with surgery alone for esophageal cancer.

    Science.gov (United States)

    Kelsen, David P; Winter, Katryn A; Gunderson, Leonard L; Mortimer, Joanne; Estes, Norman C; Haller, Daniel G; Ajani, Jaffer A; Kocha, Walter; Minsky, Bruce D; Roth, Jack A; Willett, Christopher G

    2007-08-20

    We update Radiation Therapy Oncology Group trial 8911 (USA Intergroup 113), a comparison of chemotherapy plus surgery versus surgery alone for patients with localized esophageal cancer. The relationship between resection type and between tumor response and outcome were also analyzed. The chemotherapy group received preoperative cisplatin plus fluorouracil. Outcome based on the type of resection (R0, R1, R2, or no resection) was evaluated. The main end point was overall survival. Disease-free survival, relapse pattern, the influence of postoperative treatment, and the relationship between response to preoperative chemotherapy and outcome were also evaluated. Two hundred sixteen patients received preoperative chemotherapy, 227 underwent immediate surgery. Fifty-nine percent of surgery only and 63% of chemotherapy plus surgery patients underwent R0 resections (P = .5137). Patients undergoing less than an R0 resection had an ominous prognosis; 32% of patients with R0 resections were alive and free of disease at 5 years, only 5% of patients undergoing an R1 resection survived for longer than 5 years. The median survival rates for patients with R1, R2, or no resections were not significantly different. While, as initially reported, there was no difference in overall survival for patients receiving perioperative chemotherapy compared with the surgery only group, patients with objective tumor regression after preoperative chemotherapy had improved survival. For patients with localized esophageal cancer, whether or not preoperative chemotherapy is administered, only an R0 resection results in substantial long-term survival. Even microscopically positive margins are an ominous prognostic factor. After a R1 resection, postoperative chemoradiotherapy therapy offers the possibility of long-term disease-free survival to a small percentage of patients.

  7. Comparative evidence on harms in pediatric randomized clinical trials from less developed versus more developed countries is limited.

    Science.gov (United States)

    Tedesco, Dario; Farid-Kapadia, Mufiza; Offringa, Martin; Bhutta, Zulfiqar A; Maldonado, Yvonne; Ioannidis, John P A; Contopoulos-Ioannidis, Despina G

    2018-03-01

    Evaluate comparative harm rates from medical interventions in pediatric randomized clinical trials (RCTs) from more developed (MDCs) and less developed countries (LDCs). Meta-epidemiologic empirical evaluation of Cochrane Database of Systematic Reviews (June 2014) meta-analyses reporting clinically important harm-outcomes (severe adverse events [AEs], discontinuations due to AEs, any AE, and mortality) that included at least one pediatric RCT from MDCs and at least one from LDCs. We estimated relative odds ratios (RORs) for each harm, within each meta-analysis, between RCTs from MDCs and LDCs and calculated random-effects-summary-RORs (sRORs) for each harm across multiple meta-analyses. Only 1% (26/2,363) of meta-analyses with clinically important harm-outcomes in the entire Cochrane Database of Systematic Reviews included pediatric RCTs both from MDCs and LDCs. We analyzed 26 meta-analyses with 244 data sets from pediatric RCTs, 116 from MDCs and 128 from LDCs (64 and 66 unique RCTs respectively). The summary ROR was 0.92 (95% confidence intervals: 0.78-1.08) for severe AEs; 1.13 (0.54-2.34) for discontinuations due to AEs; 1.10 (0.77-1.59) for any AE; and 0.99 (0.61-1.61) for mortality and for the all-harms-combined-end point 0.96 (0.83-1.10). Differences of ROR-point-estimates ≥2-fold between MDCs and LDCs were identified in 35% of meta-analyses. We found no major systematic differences in harm rates in pediatric trials between MDCs and LDCs, but data on harms in children were overall very limited. Copyright © 2017 Elsevier Inc. All rights reserved.

  8. At what price? A cost-effectiveness analysis comparing trial of labour after previous caesarean versus elective repeat caesarean delivery.

    Directory of Open Access Journals (Sweden)

    Christopher G Fawsitt

    Full Text Available BACKGROUND: Elective repeat caesarean delivery (ERCD rates have been increasing worldwide, thus prompting obstetric discourse on the risks and benefits for the mother and infant. Yet, these increasing rates also have major economic implications for the health care system. Given the dearth of information on the cost-effectiveness related to mode of delivery, the aim of this paper was to perform an economic evaluation on the costs and short-term maternal health consequences associated with a trial of labour after one previous caesarean delivery compared with ERCD for low risk women in Ireland. METHODS: Using a decision analytic model, a cost-effectiveness analysis (CEA was performed where the measure of health gain was quality-adjusted life years (QALYs over a six-week time horizon. A review of international literature was conducted to derive representative estimates of adverse maternal health outcomes following a trial of labour after caesarean (TOLAC and ERCD. Delivery/procedure costs derived from primary data collection and combined both "bottom-up" and "top-down" costing estimations. RESULTS: Maternal morbidities emerged in twice as many cases in the TOLAC group than the ERCD group. However, a TOLAC was found to be the most-effective method of delivery because it was substantially less expensive than ERCD (€ 1,835.06 versus € 4,039.87 per women, respectively, and QALYs were modestly higher (0.84 versus 0.70. Our findings were supported by probabilistic sensitivity analysis. CONCLUSIONS: Clinicians need to be well informed of the benefits and risks of TOLAC among low risk women. Ideally, clinician-patient discourse would address differences in length of hospital stay and postpartum recovery time. While it is premature advocate a policy of TOLAC across maternity units, the results of the study prompt further analysis and repeat iterations, encouraging future studies to synthesis previous research and new and relevant evidence under a single

  9. Combined written and oral information prior to gastrointestinal endoscopy compared with oral information alone: a randomized trial

    Directory of Open Access Journals (Sweden)

    Azar-Pey Nadereh

    2008-06-01

    Full Text Available Abstract Background Little is known about how to most effectively deliver relevant information to patients scheduled for endoscopy. Methods To assess the effects of combined written and oral information, compared with oral information alone on the quality of information before endoscopy and the level of anxiety. We designed a prospective study in two Swiss teaching hospitals which enrolled consecutive patients scheduled for endoscopy over a three-month period. Patients were randomized either to receiving, along with the appointment notice, an explanatory leaflet about the upcoming examination, or to oral information delivered by each patient's doctor. Evaluation of quality of information was rated on scales between 0 (none received and 5 (excellent. The analysis of outcome variables was performed on the basis of intention to treat-analysis. Multivariate analysis of predictors of information scores was performed by linear regression analysis. Results Of 718 eligible patients 577 (80% returned their questionnaire. Patients who received written leaflets (N = 278 rated the quality of information they received higher than those informed verbally (N = 299, for all 8 quality-of-information items. Differences were significant regarding information about the risks of the procedure (3.24 versus 2.26, p Conclusion Written information led to more favourable assessments of the quality of information and had no impact on patient anxiety nor on the overall assessment of the endoscopy. Because structured and comprehensive written information is perceived as beneficial by patients, gastroenterologists should clearly explain to their patients the risks, benefits and alternatives of endoscopic procedures. Trial registration: Current Controlled trial number: ISRCTN34382782.

  10. Meta-analysis of randomized, controlled trials comparing particular doses of griseofulvin and terbinafine for the treatment of tinea capitis.

    Science.gov (United States)

    Gupta, Aditya K; Drummond-Main, Chris

    2013-01-01

    Two oral antifungal agents, griseofulvin and terbinafine, have regulatory approval in the United States, but it is unknown whether one has superior overall efficacy. Genus-specific differences in efficacy are believed to exist for the two agents. It is not clear at what doses and durations of treatment these differences apply. The goals of this meta-analysis were to determine whether a statistically significant difference in efficacy exists between these agents at a given dose and duration of each in tinea capitis infections overall and to determine whether a genus-specific difference in efficacy exists for these two treatments at a given dose and duration of each. We performed a literature search for clinically and methodologically similar randomized controlled trials comparing 8 weeks of griseofulvin (6.25-12.5 mg/kg/day) to 4 weeks of terbinafine (3.125-6.25 mg/kg/day) in the treatment of tinea capitis. A meta-analysis was performed using the Mantel-Haenszel method and random effects model; results were expressed as odds ratios with 95% confidence intervals. Meta-analysis of randomized controlled trials did not show a significant difference in the overall efficacy of the two drugs at the doses specified, but specific efficacy differences were observed based on the infectious species. For tinea capitis caused by Microsporum spp., griseofulvin is superior (p = 0.04), whereas terbinafine is superior for Trichophyton spp. infection (p = 0.04). Our results support species-specific differences in treatment efficacy between griseofulvin and terbinafine and provide a clinical context in which this knowledge may be applied. © 2012 Wiley Periodicals, Inc.

  11. Adherence to isoniazid prophylaxis among HIV-infected children: a randomized controlled trial comparing two dosing schedules

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    le Roux David M

    2009-11-01

    Full Text Available Abstract Background Tuberculosis contributes significantly to morbidity and mortality among HIV-infected children in sub-Saharan Africa. Isoniazid prophylaxis can reduce tuberculosis incidence in this population. However, for the treatment to be effective, adherence to the medication must be optimized. We investigated adherence to isoniazid prophylaxis administered daily, compared to three times a week, and predictors of adherence amongst HIV-infected children. Methods We investigated adherence to study medication in a two centre, randomized trial comparing daily to three times a week dosing of isoniazid. The study was conducted at two tertiary paediatric care centres in Cape Town, South Africa. Over a 5 year period, we followed 324 HIV-infected children aged ≥ 8 weeks. Adherence information based on pill counts was available for 276 children. Percentage adherence was calculated by counting the number of pills returned. Adherence ≥ 90% was considered to be optimal. Analysis was done using summary and repeated measures, comparing adherence to the two dosing schedules. Mean percentage adherence (per child during follow-up time was used to compare the mean of each group as well as the proportion of children achieving an adherence of ≥ 90% in each group. For repeated measures, percentage adherence (per child per visit was dichotomized at 90%. A logistic regression model with generalized estimating equations, to account for within-individual correlation, was used to evaluate the impact of the dosing schedule. Adjustments were made for potential confounders and we assessed potential baseline and time-varying adherence determinants. Results The overall adherence to isoniazid was excellent, with a mean adherence of 94.7% (95% confidence interval [CI] 93.5-95.9; similar mean adherence was achieved by the group taking daily medication (93.8%; 95% CI 92.1-95.6 and by the three times a week group (95.5%; 95% CI 93.8-97.2. Two-hundred and seventeen (78

  12. Comparing systemic therapy and cognitive behavioral therapy for social anxiety disorders: study protocol for a randomized controlled pilot trial.

    Science.gov (United States)

    Hunger, Christina; Hilzinger, Rebecca; Koch, Theresa; Mander, Johannes; Sander, Anja; Bents, Hinrich; Schweitzer, Jochen

    2016-03-31

    Social anxiety disorders are among the most prevalent anxiety disorders in the general population. The efficacy of cognitive behavioral therapy (CBT) for social anxiety disorders is well demonstrated. However, only three studies point to the efficacy of systemic therapy (ST) in anxiety disorders, and only two of them especially focus on social anxiety disorders. These ST studies either do not use a good comparator but minimal supportive therapy, they do not use a multi-person ST but a combined therapy, or they do not especially focus on social anxiety disorders but mood and anxiety disorders in general. Though ST was approved as evidence based in Germany for a variety of disorders in 2008, evidence did not include anxiety disorders. This is the first pilot study that will investigate multi-person ST, integrating a broad range of systemic methods, specifically for social anxiety disorders and that will compare ST to the "gold standard" CBT. This article describes the rationale and protocol of a prospective, open, interventive, balanced, bi-centric, pilot randomized controlled trial (RCT). A total of 32 patients with a primary SCID diagnosis of social anxiety disorder will be randomized to either CBT or ST. Both treatments will be manualized. The primary outcome will include social anxiety symptoms at the end of therapy. Therapy will be restricted to no more than 26 hours (primary endpoint). Secondary outcomes will include psychological, social systems and interpersonal functioning, symptom adjustment, and caregiver burden, in addition to change measures, therapist variables and treatment adherence. At the secondary endpoints, 9 and 12 months after the beginning of therapy, we will again assess all outcomes. The study is expected to pilot test a RCT which will be the first to directly compare CBT and multi-person ST, integrating a broad range of systemic methods, for social anxiety disorders, and it will provide empirical evidence for the calculation of the number of

  13. INCITE: A randomised trial comparing constraint induced movement therapy and bimanual training in children with congenital hemiplegia

    Directory of Open Access Journals (Sweden)

    Gilmore Rose

    2010-01-01

    , strength and sensation, activity limitations (upper limb unimanual capacity and bimanual motor coordination, participation restrictions (in home, school and recreation, environmental (barriers and facilitators to participation and quality of life. Discussion This paper outlines the theoretical basis, study hypotheses and outcome measures for a matched pairs randomised trial comparing CIMT and BIM training to improve outcomes across the ICF. Trial Registration ACTRN12609000912280

  14. Magnitude of placebo response and response variance in antidepressant clinical trials using structured, taped and appraised rater interviews compared to traditional rating interviews.

    Science.gov (United States)

    Khan, Arif; Faucett, James; Brown, Walter A

    2014-04-01

    The high failure rate of antidepressant clinical trials is due in part to a high magnitude of placebo response and considerable variance in placebo response. In some recent trials enhanced patient interview techniques consisting of Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale (SIGMA) interviews, audiotaping of patient interviews and 'central' appraisal with Rater Applied Performance Scale (RAPS) criteria have been implemented in the hope of increasing reliability and thus reducing the placebo response. However, the data supporting this rationale for a change in patient interview technique are sparse. We analyzed data from depressed patients assigned to placebo in antidepressant clinical trials conducted at a single research site between 2008 and 2012. Three trials included 34 depressed patients undergoing SIGMA depression interviews with taping and RAPS appraisal and 4 trials included 128 depressed patients using traditional interview methods. Using patient level data we assessed the mean decrease in total MADRS scores and the variability of the decrease in MADRS scores in trials using SIGMA interviews versus trials using traditional interviews. Mean decrease in total MADRS score was significantly higher in the 3 trials that used SIGMA interviews compared to the 4 trials using traditional interviews (M = 13.0 versus 8.3, t(df = 160) = 2.04, p = 0.047). Furthermore, trials using SIGMA had a larger magnitude of response variance based on Levene's test for equality of variance (SD = 12.3 versus 9.4, F = 7.3, p = 0.008). The results of our study suggest that enhanced patient interview techniques such as SIGMA interviews, audiotaping and RAPS appraisal may not result in the intended effect of reducing the magnitude of placebo response and placebo variance. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

  15. Long-term Follow-up of a Randomized Controlled Trial Comparing Scarf to Chevron Osteotomy in Hallux Valgus Correction.

    Science.gov (United States)

    Jeuken, Ralph M; Schotanus, Martijn G M; Kort, Nanne P; Deenik, Axel; Jong, Bob; Hendrickx, Roel P M

    2016-07-01

    Hallux valgus is one of the most common foot deformities. This long-term follow-up study compared the results of 2 widely used operative treatments for hallux valgus: the scarf and chevron osteotomy. Conventional weight bearing anteroposterior (AP) radiographs of the foot were made for evaluating the intermetatarsal angle and hallux valgus angle. For clinical evaluation, the American Orthopaedic Foot & Ankle Society (AOFAS) rating system for the hallux metatarsophalangeal-interphalangeal scale was used together with physical examination of the foot. These data were compared with the results from the original study. The Short Form 36 questionnaire, the Manchester-Oxford Foot Questionnaire (MOXFQ), and a general questionnaire including a visual analog scale (VAS) pain score were used for subjective evaluation. The primary outcome measures were the radiologic recurrence of hallux valgus and reoperation rate of the same toe. Secondary outcome measures were the results from the radiographs and subjective and clinical evaluation. The response rate was 76% at the follow-up of 14 years; in the chevron group, 37 feet were included compared with 36 feet in the scarf group. Twenty-eight feet in the chevron group and 27 in the scarf group developed recurrence of hallux valgus (P = .483). One patient in the scarf group had a reoperation of the same toe compared with none in the chevron group (P = .314). Current VAS pain scores and results from the SF-36, MOXFQ, and AOFAS did not significantly differ between groups. Both techniques showed similar results after 2 years of follow-up. At 14 years of follow-up, neither technique was superior in preventing recurrence. Level II, randomized controlled trial. © The Author(s) 2016.

  16. Prospective multicenter randomized controlled trial comparing adenoma detection rate in colonoscopy using water exchange, water immersion, and air insufflation.

    Science.gov (United States)

    Hsieh, Yu-Hsi; Tseng, Chih-Wei; Hu, Chi-Tan; Koo, Malcolm; Leung, Felix W

    2017-07-01

    Adenoma detection rate (ADR), defined as the proportion of patients with at least one adenoma of any size, is a quality indicator. We tested the hypothesis that water exchange (WE) improves ADR but water immersion (WI) has no adverse effect on ADR compared with air insufflation (AI). A prospective study was conducted at the Dalin Tzu Chi Hospital in southern Taiwan and the Hualien Tzu Chi Hospital in eastern Taiwan on patients randomly assigned to WE, WI, or AI with stratification by the 3 study colonoscopists. The primary outcome was ADR. From July 2013 to December 2015, 651 patients were recruited and randomized into 3 groups with a 1:1:1 ratio (217 patients per group). Overall, ADR met quality standards: WE 49.8% (95% CI, 43.2%-56.4%), AI 37.8% (95% CI, 31.6%-44.4%), and WI 40.6% (95% CI, 34.2%-47.2%). Compared with AI, WE significantly increased ADR (P = .016). There was no difference between WI and WE. ADRs of WI and AI were comparable. Compared with AI, WE confirmed a longer insertion time, higher cleanliness score, but similar adenoma per positive colonoscopy (APPC) and withdrawal time with polypectomy. Subgroup analysis found WE significantly increased ADR in propofol-sedated patients. Multivariate generalized linear mixed model analysis revealed that age ≥50 years, WE (vs AI), colonoscopy indication, no previous history of colonoscopy, and withdrawal time >8 minutes were significant predictors of increased ADR. Confirmation of prior reports showing WE, but not WI, increased ADR further strengthened the validity of our observations. WE significantly increased ADR in propofol-sedated patients. The outcome differences justify assessment of the role of WE in colorectal cancer prevention. Similar APPC and withdrawal times suggest that adequate inspection was performed on colonoscope withdrawal in each of the study arms. (Clinical trial registration number: NCT01894191.). Copyright © 2017 American Society for Gastrointestinal Endoscopy. All rights reserved.

  17. Randomized, controlled trial comparing the effects of anesthesia with propofol, isoflurane, desflurane and sevoflurane on pain after laparoscopic cholecystectomy

    Directory of Open Access Journals (Sweden)

    Jaime Ortiz

    2014-06-01

    Full Text Available Background: Pain is the primary complaint and the main reason for prolonged recovery after laparoscopic cholecystectomy. The authors hypothesized that patients undergoing laparoscopic cholecystectomy will have less pain four hours after surgery when receiving maintenance of anesthesia with propofol when compared to isoflurane, desflurane, or sevoflurane. Methods: In this prospective, randomized trial, 80 patients scheduled for laparoscopic cholecystectomy were assigned to propofol, isoflurane, desflurane, or sevoflurane for the maintenance of anesthesia. Our primary outcome was pain measured on the numeric analog scale four hours after surgery. We also recorded intraoperative use of opioids as well as analgesic consumption during the first 24 h after surgery. Results: There was no statistically significant difference in pain scores four hours after surgery (p = 0.72. There were also no statistically significant differences in pain scores between treatment groups during the 24 h after surgery (p = 0.45. Intraoperative use of fentanyl and morphine did not vary significantly among the groups (p = 0.21 and 0.24, respectively. There were no differences in total morphine and hydrocodone/APAP use during the first 24 h (p = 0.61 and 0.53, respectively. Conclusion: Patients receiving maintenance of general anesthesia with propofol do not have less pain after laparoscopic cholecystectomy when compared to isoflurane, desflurane, or sevoflurane.

  18. A randomized controlled trial comparing alpha blocker (tamsulosin) and anticholinergic (solifenacin) in treatment of ureteral stent-related symptoms.

    Science.gov (United States)

    El-Nahas, Ahmed R; Tharwat, Mohamed; Elsaadany, Mohamed; Mosbah, Ahmed; Gaballah, Mohamed A

    2016-07-01

    To compare the effectiveness of tamsulosin and solifenacin in relieving ureteral stents related symptoms. A randomized controlled trial was conducted between January 2013 and July 2014. Inclusion criteria were patients aged 20-50 years who underwent temporary unilateral ureteral stent for drainage of calcular upper tract obstruction or after ureteroscopic lithotripsy. Patients with history of lower urinary tract symptoms before stent placement, stents that were fixed after open or laparoscopic procedures, and those who developed complications related to the primary procedure were not included. Eligible patients were randomly assigned to 1 of 3 groups using computer-generated random tables. Patients in group 1 received placebo, patients in group 2 received tamsulosin 0.4 mg once daily, and those in group 3 received solifenacin 5 mg once daily. Ureteral Stent Symptom Questionnaire (USSQ) was answered by all patients 1-2 weeks after stent placement. The primary outcome was the comparison of total score of USSQ between all groups. The study included 131 patients. All baseline characteristics (age, sex, side, indication, length, and duration of stent) were comparable for all groups. Total USSQ score was 61 in solifenacin group, 76 in tamsulosin group, and 83 in control group (P tamsulosin group (P tamsulosin alone or solifenacin alone in patients with ureteral stents can improve the quality of life by decreasing ureteral stent-related symptoms. Solifenacin was better than tamsulosin. CLINICALTRIAL. NCT01880619.

  19. Cognitive behavioral therapy vs. Tai Chi for late life insomnia and inflammatory risk: a randomized controlled comparative efficacy trial.

    Science.gov (United States)

    Irwin, Michael R; Olmstead, Richard; Carrillo, Carmen; Sadeghi, Nina; Breen, Elizabeth C; Witarama, Tuff; Yokomizo, Megumi; Lavretsky, Helen; Carroll, Judith E; Motivala, Sarosh J; Bootzin, Richard; Nicassio, Perry

    2014-09-01

    To investigate the comparative efficacy of cognitive behavioral therapy (CBT), Tai Chi Chih (TCC), and sleep seminar education control (SS) on the primary outcome of insomnia diagnosis, and secondary outcomes of sleep quality, fatigue, depressive symptoms, and inflammation in older adults with insomnia. Randomized controlled, comparative efficacy trial. Los Angeles community. 123 older adults with chronic and primary insomnia. Random assignment to CBT, TCC, or SS for 2-hour group sessions weekly over 4 months with follow-up at 7 and 16 months. Insomnia diagnosis, patient-reported outcomes, polysomnography (PSG), and high-sensitivity C-reactive protein (CRP) levels. CBT performed better than TCC and SS in remission of clinical insomnia as ascertained by a clinician (P 3.0 mg/L) at 16 months (odds ratio [OR], 0.26 [95% CI, 0.07-0.97] P insomnia was associated with lower levels of CRP (P insomnia remission. PSG measures did not change. Treatment of late-life insomnia is better achieved and sustained by cognitive behavioral therapies. Insomnia treatment and remission reduces a marker of inflammatory risk, which has implications for cardiovascular morbidity and diabetes observed with sleep disturbance in epidemiologic surveys. © 2014 Associated Professional Sleep Societies, LLC.

  20. Online assessment of ALS functional rating scale compares well to in-clinic evaluation: a prospective trial.

    Science.gov (United States)

    Maier, André; Holm, Teresa; Wicks, Paul; Steinfurth, Laura; Linke, Peter; Münch, Christoph; Meyer, Robert; Meyer, Thomas

    2012-02-01

    Self-assessment of symptom progression in chronic diseases is of increasing importance in clinical research, patient management and specialized outpatient care. Against this background, we developed a secure internet platform (ALShome.de) that allows online assessment of the revised ALS Functional Rating Scale (ALSFRS-R) and other established self-assessment questionnaires. We developed a secure and closed internet portal to assess patient reported outcomes. In a prospective, controlled and stratified study, patients conducted a web-based self-assessment of ALSFRS-R compared to on-site assessment. On-site and online assessments were compared at baseline (n = 127) and after 3.5 months (n = 81, 64%). Results showed that correlation between on-site evaluation and online testing of ALSFRS-R was highly significant (r = 0.96; p online vs. on-site) was excellent (mean interval, 8.8 days). The adherence to online rating was high; 75% of patients tested on-site completed a follow-up online visit (mean 3.5 months, SD 1.7). We conclude that online self-assessment of ALS severity complements the well-established face-to-face application of the ALSFRS-R during on-site visits. The results of our study support the use of online administration of ALSFRS-R within clinical trials and for managing the care of ALS patients.

  1. Influenza detection and prediction algorithms: comparative accuracy trial in Östergötland county, Sweden, 2008-2012.

    Science.gov (United States)

    Spreco, A; Eriksson, O; Dahlström, Ö; Timpka, T

    2017-07-01

    Methods for the detection of influenza epidemics and prediction of their progress have seldom been comparatively evaluated using prospective designs. This study aimed to perform a prospective comparative trial of algorithms for the detection and prediction of increased local influenza activity. Data on clinical influenza diagnoses recorded by physicians and syndromic data from a telenursing service were used. Five detection and three prediction algorithms previously evaluated in public health settings were calibrated and then evaluated over 3 years. When applied on diagnostic data, only detection using the Serfling regression method and prediction using the non-adaptive log-linear regression method showed acceptable performances during winter influenza seasons. For the syndromic data, none of the detection algorithms displayed a satisfactory performance, while non-adaptive log-linear regression was the best performing prediction method. We conclude that evidence was found for that available algorithms for influenza detection and prediction display satisfactory performance when applied on local diagnostic data during winter influenza seasons. When applied on local syndromic data, the evaluated algorithms did not display consistent performance. Further evaluations and research on combination of methods of these types in public health information infrastructures for 'nowcasting' (integrated detection and prediction) of influenza activity are warranted.

  2. Neonatal outcomes in women with gestational diabetes mellitus treated with metformin in compare with insulin: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Safura Ruholamin

    2014-01-01

    Full Text Available Background: The objective of this study was to compare neonatal outcomes in women with gestational diabetes mellitus (GDM treated with either metformin or insulin. Materials and Methods: A randomized clinical trial carried out on year 2011 on 109 women with GDM who did not adequately control by dietary measures. They received metformin 500 mg once or twice daily or insulin 0.2 IU/kg/day initially. The dose was titrated to achieve target blood glucose values. Neonatal outcomes such as hypoglycemia, birth weight, Apgar score, umbilical artery pH, and hyperbilirubinemia in the 50 women who remained exclusively on metformin were compared with 50 women who treated with insulin. Results: Two groups were similar in mean fasting blood sugar (P = 0.7 and postprandial measurements (P = 0.8 throughout GDM treatment. Pregnancy complications or preterm labor were not different significantly between two groups. Considering neonatal outcomes between insulin and metformin groups, such as hypoglycemia (2 [4%] and 0 [0%], respectively, birth weight (3342 ± 506 mg and 3176 ± 438 mg, respectively, 5 th min Apgar score <7 (no one in either group, umbilical artery pH <7.05 (no one in either group and hyperbilirubinemia (1 [2%] and 0 [0%], respectively, no significant statistical differences were seen. Conclusion: Based on these preliminary data, considering neonatal outcomes, metformin appears to be a safe as insulin in the treatment of GDM.

  3. Benchmarking trial between France and Australia comparing management of primary rectal cancer beyond TME and locally recurrent rectal cancer (PelviCare Trial): rationale and design

    International Nuclear Information System (INIS)

    Denost, Quentin; Saillour, Florence; Masya, Lindy; Martinaud, Helene Maillou; Guillon, Stephanie; Kret, Marion; Rullier, Eric; Quintard, Bruno; Solomon, Michael

    2016-01-01

    Among patients with rectal cancer, 5–10 % have a primary rectal cancer beyond the total mesorectal excision plane (PRC-bTME) and 10 % recur locally following primary surgery (LRRC). In both cases, patients ‘care remains challenging with a significant worldwide variation in practice regarding overall management and criteria for operative intervention. These variations in practice can be explained by structural and organizational differences, as well as cultural dissimilarities. However, surgical resection of PRC-bTME and LRRC provides the best chance of long-term survival after complete resection (R0). With regards to the organization of the healthcare system and the operative criteria for these patients, France and Australia seem to be highly different. A benchmarking-type analysis between French and Australian clinical practice, with regards to the care and management of PRC-bTME and LRRC, would allow understanding of patients’ care and management structures as well as individual and collective mechanisms of operative decision-making in order to ensure equitable practice and improve survival for these patients. The current study is an international Benchmarking trial comparing two cohorts of 120 consecutive patients with non-metastatic PRC-bTME and LRRC. Patients with curative and palliative treatment intent are included. The study design has three main parts: (1) French and Australian cohorts including clinical, radiological and surgical data, quality of life (MOS SF36, FACT-C) and distress level (Distress thermometer) at the inclusion, 6 and 12 months; (2) experimental analyses consisting of a blinded inter-country reading of pelvic MRI to assess operatory decisions; (3) qualitative analyses based on MDT meeting observation, semi-structured interviews and focus groups of health professional attendees and conducted by a research psychologist in both countries using the same guides. The primary endpoint will be the clinical resection rate. Secondary end

  4. Perceived quality of physiotherapist-led orthopaedic triage compared with standard practice in primary care: a randomised controlled trial.

    Science.gov (United States)

    Samsson, Karin S; Bernhardsson, Susanne; Larsson, Maria E H

    2016-06-10

    Physiotherapist-led orthopaedic triage, where physiotherapists diagnose and determine management plans, aims to enhance effectiveness and provide the best care. However, scientific evidence for the effectiveness of this model of care remains limited, and there are few studies reporting on patients' perceptions of the care provided. The purpose of this study was to evaluate patients' perceived quality of care in a physiotherapist-led orthopaedic triage in primary care, compared with standard practice. In a randomised controlled trial, patients of working age referred for orthopaedic consultation at a primary healthcare clinic in Sweden received either physiotherapist-led triage (n = 102) or standard practice (orthopaedic surgeon assessment) (n = 101). Neither subjects nor clinicians were blinded. The questionnaire Quality from the Patient's Perspective (QPP) was used to evaluate perceived quality of care focusing on the caregivers' medical-technical competence and identity-orientated approach. Also, to what extent patients' expectations were met, and their intention to follow advice was evaluated. For this study, 163 patients (80 %) were analysed (physiotherapist-led triage (n = 83), standard practice (n = 80)). Participants perceived significantly higher quality of care with the triage than with the standard practice in regards to receiving best possible examination and treatment (medical-technical competence) (p quality of care in a physiotherapist-led orthopaedic triage compared with standard practice. Patients in both groups reported that they perceived good quality of care, with the patients in the physiotherapist-led triage reporting significantly higher perceived quality of care than those in the standard practice group. This model of care seems to meet patients' expectations and result in a greater intention to follow advice and instructions for self-management. Our findings are in line with existing literature that this model of care

  5. Sacral neuromodulation compared with injection of bulking agents for faecal incontinence following obstetric anal sphincter injury - a randomized controlled trial.

    Science.gov (United States)

    Rydningen, M; Dehli, T; Wilsgaard, T; Rydning, A; Kumle, M; Lindsetmo, R O; Norderval, S

    2017-05-01

    The purpose of this trial was to compare the effectiveness of sacral neuromodulation (SNM) with a submucosal injection of collagen (Permacol®) in women with faecal incontinence following obstetric anal sphincter injury (OASIS). This single-blinded randomized controlled trial at two hospital units in Norway included women with faecal incontinence following OASIS. Eligible women who had had a successful percutaneous nerve evaluation were randomly assigned to SNM or Permacol®. The primary outcome was the difference in the St Mark's incontinence score between baseline and 6 months. Secondary outcomes were changes in the disease-specific quality of life (FIQL) and urinary incontinence (ICIQ-UI-SF) scores. Fifty-eight women were randomly assigned to SNM (n = 30) and Permacol® (n = 28). The reduction in the St Mark's score between baseline and 6 months was 11.2 (SD 5.3) in the SNM group vs 2.3 (SD 5.0) in the Permacol® group, resulting in a difference of 8.9 (95% CI: 6.1-11.7, P < 0.0001). The differences in the four scales of FIQL (lifestyle, coping, depression, embarrassment) were 0.90 (95% CI: 0.50-1.30, P < 0.001), 1.05 (0.62-1.47, P < 0.001), 0.52 (95% CI: 0.16-0.87, P = 0.005) and 0.95 (95% CI: 0.50-1.40, P < 0.001), respectively, in favour of SNM. The difference in the ICIQ-UI-SF was 5.0 (95% CI: 1.97-8.02, P = 0.002) in favour of SNM. There were nine minor adverse events in the SNM group compared with seven in the Permacol® group (P = 0.77). SNM was superior to Permacol® in terms of reduction of St Mark's score, ICIQ-UI-SF and the change of the FIQL in women with faecal incontinence following OASIS. Colorectal Disease © 2017 The Association of Coloproctology of Great Britain and Ireland.

  6. Comparative effects of snoring sound between two minimally invasive surgeries in the treatment of snoring: a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Li-Ang Lee

    Full Text Available BACKGROUND: Minimally invasive surgeries of the soft palate have emerged as a less-invasive treatment for habitual snoring. To date, there is only limited information available comparing the effects of snoring sound between different minimally invasive surgeries in the treatment of habitual snoring. OBJECTIVE: To compare the efficacy of palatal implant and radiofrequency surgery, in the reduction of snoring through subjective evaluation of snoring and objective snoring sound analysis. PATIENTS AND METHOD: Thirty patients with habitual snoring due to palatal obstruction (apnea-hypopnea index ≤15, body max index ≤30 were prospectively enrolled and randomized to undergo a single session of palatal implant or temperature-controlled radiofrequency surgery of the soft palate under local anesthesia. Snoring was primarily evaluated by the patient with a 10 cm visual analogue scale (VAS at baseline and at a 3-month follow-up visit and the change in VAS was the primary outcome. Moreover, life qualities, measured by snore outcomes survey, and full-night snoring sounds, analyzed by a sound analytic program (Snore Map, were also investigated at the same time. RESULTS: Twenty-eight patients completed the study; 14 received palatal implant surgery and 14 underwent radiofrequency surgery. The VAS and snore outcomes survey scores were significantly improved in both groups. However, the good response (postoperative VAS ≤3 or postoperative VAS ≤5 plus snore outcomes survey score ≥60 rate of the palatal implant group was significantly higher than that of the radiofrequency group (79% vs. 29%, P = 0.021. The maximal loudness of low-frequency (40-300 Hz snores was reduced significantly in the palatal implant group. In addition, the snoring index was significantly reduced in the radiofrequency group. CONCLUSIONS: Both palatal implants and a single-stage radiofrequency surgery improve subjective snoring outcomes, but palatal implants have a greater effect

  7. Spirulina platensis versus silymarin in the treatment of chronic hepatitis C virus infection. A pilot randomized, comparative clinical trial.

    Science.gov (United States)

    Yakoot, Mostafa; Salem, Amel

    2012-04-12

    Spirulina platensis, a cynobacterium used frequently as a dietary supplement had been found to exhibit many immune-stimulating and antiviral activities. It had been found to activate macrophages, NK cells, T cells, B cells, and to stimulate the production of Interferon gamma (IFN-γ) and other cytokines. Natural substances isolated from Spirulina platensis had been found to be potent inhibitors against several enveloped viruses by blocking viral absorption/penetration and some replication stages of progeny viruses after penetration into cells. We aimed to study whether this dietary supplement possesses any therapeutically feasible activity worthy of further larger controlled clinical evaluation. Sixty six patients with chronic hepatitis C virus infection and eligible for inclusion had been randomized to either Spirulina or Silymarin treated groups for a period of six months treatment.The two groups were followed up and blindly compared for early (after 3 months) and end of 6 months treatment virological response. The effects of both treatments on each of alanine aminotransferase (ALT), Chronic Liver Disease Questionnaire scores (CLDQ), Arizona Sexual Experience Scale scores (ASEX) and the occurrence of any attributable adverse events were also compared. Among the 30 patients who had been treated with Spirulina and completed the 6 months protocol, 4 patients (13.3%) had a complete end of treatment virological response and 2 patients (6.7%) had a partial end of treatment response defined as significant decrease of virus load of at least 2-logs10. Though the proportion of responders in Spirulina group was greater than in the Silymarin group, the difference was not statistically significant at the end of both 6 months (p = 0.12) and 3 months treatment (p = 0.22) by Exact test. Alanine aminotransferase as well as CLDQ and ASEX scores were found to be more significantly improved in Spirulina than in Silymarin treated group. Our results could suggest a therapeutically

  8. Comparative Effects of Different Balance-Training-Progression Styles on Postural Control and Ankle Force Production: A Randomized Controlled Trial.

    Science.gov (United States)

    Cuğ, Mutlu; Duncan, Ashley; Wikstrom, Erik

    2016-02-01

    Despite the effectiveness of balance training, the exact parameters needed to maximize the benefits of such programs remain unknown. One such factor is how individuals should progress to higher levels of task difficulty within a balance-training program. Yet no investigators have directly compared different balance-training-progression styles. To compare an error-based progression (ie, advance when proficient at a task) with a repetition-based progression (ie, advance after a set amount of repetitions) style during a balance-training program in healthy individuals. Randomized controlled trial. Research laboratory. A total of 28 (16 women, 12 men) physically healthy young adults (age = 21.57 ± 3.95 years, height = 171.60 ± 11.03 cm, weight = 72.96 ± 16.18 kg, body mass index = 24.53 ± 3.7). All participants completed 12 supervised balance-training sessions over 4 weeks. Each session consisted of a combination of dynamic unstable-surface tasks that incorporated a BOSU ball and lasted about 30 minutes. Static balance from an instrumented force plate, dynamic balance as measured via the Star Excursion Balance Test, and ankle force production in all 4 cardinal planes of motion as measured with a handheld dynamometer before and after the intervention. Selected static postural-control outcomes, dynamic postural control, and ankle force production in all planes of motion improved (P .05) for any of the outcome measures. A 4-week balance-training program consisting of dynamic unstable-surface exercises on a BOSU ball improved dynamic postural control and ankle force production in healthy young adults. These results suggest that an error-based balance-training program is comparable with but not superior to a repetition-based balance-training program in improving postural control and ankle force production in healthy young adults.

  9. Comparing the Effects of Reflexology and Footbath on Sleep Quality in the Elderly: A Controlled Clinical Trial.

    Science.gov (United States)

    Valizadeh, Leila; Seyyedrasooli, Alehe; Zamanazadeh, Vahid; Nasiri, Khadijeh

    2015-11-01

    Sleep disorders are common mental disorders reported among the elderly in all countries, and with nonpharmacological interventions, they could be helped to improve their sleep quality. The aim of this study was to compare the effects of two interventions, foot reflexology and foot bath, on sleep quality in elderly people. This three-group randomized clinical trial (two experimental groups and a control group) was conducted on 69 elderly men. The two experimental groups had reflexology (n = 23) and foot bath (n = 23) interventions for 6 weeks. The reflexology intervention was done in the mornings, once a week for ten minutes on each foot. The participants in the foot bath group were asked to soak their feet in 41°C to 42°C water one hour before sleeping. The pittsburgh sleep quality index (PSQI) was completed before and after the intervention through an interview process. The results showed that the PSQI scores after intervention compared to before it in the reflexology and foot bath groups were statistically significant (P = 0.01 , P = 0.001); however, in the control group did not show a statistically significant difference (P = 0.14). In addition, the total score changes among the three groups were statistically significant (P = 0.01). Comparing the score changes of quality of sleep between the reflexology and foot bath groups showed that there was no significant difference in none of the components and the total score (P = 0.09). The two interventions had the same impact on the quality of sleep. It is suggested that the training of nonpharmacological methods to improve sleep quality such as reflexology and foot bath be included in the elderly health programs. In addition, it is recommended that the impact of these interventions on subjective sleep quality using polysomnographic recordings be explored in future research.

  10. A Randomised Clinical Trial to Compare Coaxial and Noncoaxial Techniques in Percutaneous Core Needle Biopsy of Renal Parenchyma

    Energy Technology Data Exchange (ETDEWEB)

    Babaei Jandaghi, Ali [Guilan University of Medical Sciences, Department of Radiology, Poursina Hospital (Iran, Islamic Republic of); Lebady, Mohammadkazem; Zamani, Athar-Alsadat [Guilan University of Medical Sciences, Urology Research Center, Razi Hospital (Iran, Islamic Republic of); Heidarzadeh, Abtin [Guilan University of Medical Sciences, Department of Community Medicine (Iran, Islamic Republic of); Monfared, Ali [Guilan University of Medical Sciences, Urology Research Center, Razi Hospital (Iran, Islamic Republic of); Pourghorban, Ramin, E-mail: ramin-p2005@yahoo.com [Tehran University of Medical Sciences, Department of Radiology, Imam Khomeini Hospital Complex (Iran, Islamic Republic of)

    2017-01-15

    PurposeTo compare the coaxial and noncoaxial techniques of renal parenchymal core needle biopsy.Materials and MethodsThis is an institutional review board-approved randomised controlled trial comparing 83 patients (male, n = 49) who underwent renal parenchymal core biopsy with coaxial method and 83 patients (male, n = 40) with noncoaxial method. The rate of complications, the number of glomerular profiles, and the procedural time were evaluated in a comparison of the two methods. Correlation between the presence of renal parenchymal disease and the rate of complication was also evaluated.ResultsThe procedural time was significantly shorter in the coaxial technique (coaxial group, 5 ± 1 min; noncoaxial group, 14 ± 2 min; p < 0.001). The rates of complications for the coaxial method was significantly lower than the noncoaxial method (coaxial group, 10.8 %; noncoaxial group, 24.1 %; p = 0.025). There was no significant correlation between gender and the rate of complication. The number of glomerular profiles was significantly higher in patents who underwent renal biopsy with the coaxial method (coaxial group, 18.2 ± 9.1; noncoaxial group, 8.6 ± 5.5; p < 0.001). In the whole study population, the rate of complications was significantly higher in patients with a pathologic renal parenchyma compared to those with a normal parenchyma (19/71 vs. 10/95; p = 0.006).ConclusionsRenal parenchymal biopsy using a coaxial needle is a faster and safer method with a lower rate of complications.

  11. A Randomised Clinical Trial to Compare Coaxial and Noncoaxial Techniques in Percutaneous Core Needle Biopsy of Renal Parenchyma

    International Nuclear Information System (INIS)

    Babaei Jandaghi, Ali; Lebady, Mohammadkazem; Zamani, Athar-Alsadat; Heidarzadeh, Abtin; Monfared, Ali; Pourghorban, Ramin

    2017-01-01

    PurposeTo compare the coaxial and noncoaxial techniques of renal parenchymal core needle biopsy.Materials and MethodsThis is an institutional review board-approved randomised controlled trial comparing 83 patients (male, n = 49) who underwent renal parenchymal core biopsy with coaxial method and 83 patients (male, n = 40) with noncoaxial method. The rate of complications, the number of glomerular profiles, and the procedural time were evaluated in a comparison of the two methods. Correlation between the presence of renal parenchymal disease and the rate of complication was also evaluated.ResultsThe procedural time was significantly shorter in the coaxial technique (coaxial group, 5 ± 1 min; noncoaxial group, 14 ± 2 min; p < 0.001). The rates of complications for the coaxial method was significantly lower than the noncoaxial method (coaxial group, 10.8 %; noncoaxial group, 24.1 %; p = 0.025). There was no significant correlation between gender and the rate of complication. The number of glomerular profiles was significantly higher in patents who underwent renal biopsy with the coaxial method (coaxial group, 18.2 ± 9.1; noncoaxial group, 8.6 ± 5.5; p < 0.001). In the whole study population, the rate of complications was significantly higher in patients with a pathologic renal parenchyma compared to those with a normal parenchyma (19/71 vs. 10/95; p = 0.006).ConclusionsRenal parenchymal biopsy using a coaxial needle is a faster and safer method with a lower rate of complications.

  12. Comparative Clinical Study of Conventional Dental Implants and Mini Dental Implants for Mandibular Overdentures: A Randomized Clinical Trial.

    Science.gov (United States)

    Aunmeungtong, Weerapan; Kumchai, Thongnard; Strietzel, Frank P; Reichart, Peter A; Khongkhunthian, Pathawee

    2017-04-01

    Dental implant-retained overdentures have been chosen as the treatment of choice for complete mandibular removable dentures. Dental implants, such as mini dental implants, and components for retaining overdentures, are commercially available. However, comparative clinical studies comparing mini dental implants and conventional dental implants using different attachment for implant-retained overdentures have not been well documented. To compare the clinical outcomes of using two mini dental implants with Equator ® attachments, four mini dental implants with Equator attachments, or two conventional dental implants with ball attachments, by means of a randomized clinical trial. Sixty patients received implant-retained mandibular overdentures in the interforaminal region. The patients were divided into three groups. In Groups 1 and 2, two and four mini dental implants, respectively, were placed and immediately loaded by overdentures, using Equator ® attachments. In Group 3, conventional implants were placed. After osseointegration, the implants were loaded by overdentures, using ball attachments. The study distribution was randomized and double-blinded. Outcome measures included changes in radiological peri-implant bone level from surgery to 12 months postinsertion, prosthodontic complications and patient satisfaction. The cumulative survival rate in the three clinical groups after one year was 100%. There was no significant difference (p dental implants with Equator attachments. However, there was a significant difference in marginal bone loss and patient satisfaction between those receiving mini dental implants with Equator attachments and conventional dental implants with ball attachments. The marginal bone resorption in Group 3 was significantly higher than in Groups 1 and 2 (p dental implants can be immediately used successfully for retaining lower complete dentures, as shown after a 1-year follow up. © 2016 Wiley Periodicals, Inc.

  13. Comparing the efficacy of Emu oil with clotrimazole and hydrocortisone in the treatment of seborrheic dermatitis: A clinical trial

    Directory of Open Access Journals (Sweden)

    Yalda Attarzadeh

    2013-01-01

    Full Text Available Background: Seborrheic dermatitis (SD is a common, chronic inflammatory disease. Inflammatory reaction and oxidative stress are thought to be effective in the pathogenesis of SD. Based on anti-inflammatory and anti-oxidant properties of emu oil, this study was designed to evaluate effects of emu oil on patients suffering from SD, and to compare it with routine treatments of SD with topical steroids and antifungal agents. Materials and Methods: This clinical trial was conducted on126 patients who were randomly allocated to 2 groups: 62 in the clotrimazole vs. emu oil (group-1 and 64 in the hydrocortisone vs. emu oil (group-2. The right side of the face in both groups was treated with topical emu oil. The left side was treated with topical clotrimazole in the first group and with topical hydrocortisone in the second group. One month after the treatment, pre and post treatment symptom severity scores of pruritus, erythema and scales were compared. Results: All 3 medications significantly improved pruritus, erythema and scales (P < 0. 01. However, topical clotrimazole and hydrocortisone were significantly more effective than emu oil in improving scales (P < 0.01, and hydrocortisone was significantly more effective than emu oil in reducing pruritus (P < 0. 01. Comparing with topical clotrimazole, emu oil resulted in significantly more improvement of erythema (p:0.01. Conclusion: Emu oil is a potentially useful agent that significantly improves itching, erythema and scales associated with SD; however, it was less effective than hydrocortisone and clotrimazole which are routinely prescribed to treat SD.

  14. Comparing the efficacy of Emu oil with clotrimazole and hydrocortisone in the treatment of seborrheic dermatitis: A clinical trial

    Science.gov (United States)

    Attarzadeh, Yalda; Asilian, Ali; Shahmoradi, Zabihollah; Adibi, Neda

    2013-01-01

    Background: Seborrheic dermatitis (SD) is a common, chronic inflammatory disease. Inflammatory reaction and oxidative stress are thought to be effective in the pathogenesis of SD. Based on anti-inflammatory and anti-oxidant properties of emu oil, this study was designed to evaluate effects of emu oil on patients suffering from SD, and to compare it with routine treatments of SD with topical steroids and antifungal agents. Materials and Methods: This clinical trial was conducted on126 patients who were randomly allocated to 2 groups: 62 in the clotrimazole vs. emu oil (group-1) and 64 in the hydrocortisone vs. emu oil (group-2). The right side of the face in both groups was treated with topical emu oil. The left side was treated with topical clotrimazole in the first group and with topical hydrocortisone in the second group. One month after the treatment, pre and post treatment symptom severity scores of pruritus, erythema and scales were compared. Results: All 3 medications significantly improved pruritus, erythema and scales (P < 0. 01). However, topical clotrimazole and hydrocortisone were significantly more effective than emu oil in improving scales (P < 0.01), and hydrocortisone was significantly more effective than emu oil in reducing pruritus (P < 0. 01). Comparing with topical clotrimazole, emu oil resulted in significantly more improvement of erythema (p:0.01). Conclusion: Emu oil is a potentially useful agent that significantly improves itching, erythema and scales associated with SD; however, it was less effective than hydrocortisone and clotrimazole which are routinely prescribed to treat SD. PMID:24250695

  15. Comparing three techniques for eliciting patient values for decision making about prostate specific antigen screening: a randomized controlled trial

    Science.gov (United States)

    Pignone, Michael Patrick; Howard, Kirsten; Brenner, Alison Tytell; Crutchfield, Trisha Melinda; Hawley, Sarah Tropman; Lewis, Carmen Lynn; Sheridan, Stacey Lynn

    2014-01-01

    Background Good decision making about prostate-specific antigen (PSA) screening involves men considering how they value the different potential outcomes. The effects of different methods of helping men consider such values, however, is not clear. Methods We conducted a randomized trial to compare three methods of values clarification for decision making about PSA screening in average-risk men ages 50-70 from the US and Australia. Participants were drawn from online panels from a survey research firm in each country and were randomized by the survey firm to one of three values clarification methods (VCM): 1) a balance sheet, 2) rating and ranking task, and 3) a discrete choice experiment (DCE). The main outcome was the difference among groups in most important attribute, based on a single question post-VCM. Secondary outcomes include differences in unlabelled test choice and intent to screen. Results We enrolled 911 participants. Mean age was 59.8 years; most were Caucasian and over one-third graduated from college. Over 40% reported a PSA test within 12 months. Those who received the rating and ranking task (n= 307) were more likely to report reducing the chance of death from prostate cancer as being most important (54.4%), compared with either the balance sheet (n= 302, 35.1%) or DCE (n= 302, 32.4%) groups. (pbalance sheet were more likely (43.7%) to prefer the unlabelled PSA-like option (as opposed to the “no screening”-like option) compared with those who received rating and ranking (34.2%) or the DCE (20.2%). However, the proportion who intended to have PSA testing was high and did not differ between groups (balance sheet 77.1%; rating and ranking 76.8%; DCE 73.5%, p = 0.731). Conclusions Different values clarification methods produce different patterns of attribute importance and different preferences for screening when presented with an unlabelled choice. PMID:23400279

  16. Technique and outcomes of bladder neck intussusception during robot-assisted laparoscopic prostatectomy: A parallel comparative trial.

    Science.gov (United States)

    Tan, Hung-Jui; Xiong, Siwei; Laviana, Aaron A; Chuang, Ryan J; Treat, Eric; Walsh, Patrick C; Hu, Jim C

    2016-12-01

    Postprostatectomy incontinence significantly impairs quality of life. Although bladder neck intussusception has been reported to accelerate urinary recovery after open radical retropubic prostatectomy, its adaption to robotic surgery has not been assessed. Accordingly, we describe our technique and compare outcomes between men treated with and without bladder neck intussusception during robot-assisted laparoscopic prostatectomy. We performed a comparative trial of 48 men undergoing robot-assisted laparoscopic prostatectomy alternating between bladder neck intussusception (n = 24) and nonintussusception (n = 24). Intussusception was completed using 3-0 polyglycolic acid horizontal mattress sutures anterior and posterior to the bladder neck. We assessed baseline characteristics and clinicopathologic outcomes. Adjusting for age, body mass index, race, and D׳Amico risk classification, we prospectively compared urinary function at 2 days, 2 weeks, 2 months, and last follow-up using the urinary domain of the Expanded Prostate Cancer Index-Short Form. Baseline patient characteristics and clinicopathologic outcomes were similar between treatment groups (P>0.05). Median catheter duration (8 vs. 8d, P = 0.125) and rates of major postoperative complications (4.2% vs. 4.2%, P = 1.000) did not differ. In adjusted analyses, Expanded Prostate Cancer Index-Short Form urinary scores were significantly higher for the intussusception arm at 2 weeks (65.4 vs. 46.6, P = 0.019) before converging at 2 months (69.1 vs. 68.3, P = 0.929) after catheter removal and at last follow-up (median = 7mo, 80.5 vs. 77.0; P = 0.665). Bladder neck intussusception during robot-assisted laparoscopic prostatectomy is feasible and safe. Although the long-term effects appear limited, intussusception may improve urinary function during the early recovery period. Copyright © 2016. Published by Elsevier Inc.

  17. Comparing CISNET Breast Cancer Incidence and Mortality Predictions to Observed Clinical Trial Results of Mammography Screening from Ages 40 to 49.

    Science.gov (United States)

    van den Broek, Jeroen J; van Ravesteyn, Nicolien T; Mandelblatt, Jeanne S; Huang, Hui; Ergun, Mehmet Ali; Burnside, Elizabeth S; Xu, Cong; Li, Yisheng; Alagoz, Oguzhan; Lee, Sandra J; Stout, Natasha K; Song, Juhee; Trentham-Dietz, Amy; Plevritis, Sylvia K; Moss, Sue M; de Koning, Harry J

    2018-04-01

    The UK Age trial compared annual mammography screening of women ages 40 to 49 years with no screening and found a statistically significant breast cancer mortality reduction at the 10-year follow-up but not at the 17-year follow-up. The objective of this study was to compare the observed Age trial results with the Cancer Intervention and Surveillance Modeling Network (CISNET) breast cancer model predicted results. Five established CISNET breast cancer models used data on population demographics, screening attendance, and mammography performance from the Age trial together with extant natural history parameters to project breast cancer incidence and mortality in the control and intervention arm of the trial. The models closely reproduced the effect of annual screening from ages 40 to 49 years on breast cancer incidence. Restricted to breast cancer deaths originating from cancers diagnosed during the intervention phase, the models estimated an average 15% (range across models, 13% to 17%) breast cancer mortality reduction at the 10-year follow-up compared with 25% (95% CI, 3% to 42%) observed in the trial. At the 17-year follow-up, the models predicted 13% (range, 10% to 17%) reduction in breast cancer mortality compared with the non-significant 12% (95% CI, -4% to 26%) in the trial. The models underestimated the effect of screening on breast cancer mortality at the 10-year follow-up. Overall, the models captured the observed long-term effect of screening from age 40 to 49 years on breast cancer incidence and mortality in the UK Age trial, suggesting that the model structures, input parameters, and assumptions about breast cancer natural history are reasonable for estimating the impact of screening on mortality in this age group.

  18. Comparing adult cannabis treatment-seekers enrolled in a clinical trial with national samples of cannabis users in the United States.

    Science.gov (United States)

    McClure, Erin A; King, Jacqueline S; Wahle, Aimee; Matthews, Abigail G; Sonne, Susan C; Lofwall, Michelle R; McRae-Clark, Aimee L; Ghitza, Udi E; Martinez, Melissa; Cloud, Kasie; Virk, Harvir S; Gray, Kevin M

    2017-07-01

    Cannabis use rates are increasing among adults in the United States (US) while the perception of harm is declining. This may result in an increased prevalence of cannabis use disorder and the need for more clinical trials to evaluate efficacious treatment strategies. Clinical trials are the gold standard for evaluating treatment, yet study samples are rarely representative of the target population. This finding has not yet been established for cannabis treatment trials. This study compared demographic and cannabis use characteristics of a cannabis cessation clinical trial sample (run through National Drug Abuse Treatment Clinical Trials Network) with three nationally representative datasets from the US; 1) National Survey on Drug Use and Health, 2) National Epidemiologic Survey on Alcohol and Related Conditions-III, and 3) Treatment: Episodes Data Set - Admissions. Comparisons were made between the clinical trial sample and appropriate cannabis using sub-samples from the national datasets, and propensity scores were calculated to determine the degree of similarity between samples. showed that the clinical trial sample was significantly different from all three national datasets, with the clinical trial sample having greater representation among older adults, African Americans, Hispanic/Latinos, adults with more education, non-tobacco users, and daily and almost daily cannabis users. These results are consistent with previous studies of other substance use disorder populations and extend sample representation issues to a cannabis use disorder population. This illustrates the need to ensure representative samples within cannabis treatment clinical trials to improve the generalizability of promising findings. Copyright © 2017 Elsevier B.V. All rights reserved.

  19. Adherence of trials of operative intervention to the CONSORT statement extension for non-pharmacological treatments: a comparative before and after study.

    Science.gov (United States)

    Gray, R; Sullivan, M; Altman, D G; Gordon-Weeks, A N

    2012-09-01

    Use of the Consolidated Standards of Reporting Trials (CONSORT) statement has been shown to improve the reporting of randomised controlled trials and it is endorsed by leading surgical journals. The CONSORT statement for non-pharmacological treatment (CONSORT-NPT) provides specific items to aid in the reporting of trials of operative intervention. This study compares the reporting practice of trials of operative intervention published in time periods before and after publication of the CONSORT-NPT statement. A 30-point checklist containing the salient CONSORT-NPT items was designed and the adherence of trials meeting the inclusion criteria determined independently by two authors. There was a significant improvement of 3.95 points in the mean CONSORT-NPT score from 2004 to 2010 (95% confidence interval: 3.61-4.29, pCONSORT statement rather than to CONSORT-NPT items, which remained poorly reported in 2010. The mean CONSORT-NPT score was 17.5 (standard deviation [SD]: 4.5) for trials published in CONSORT endorsing journals compared with 15.6 (SD: 4.0) for those that did not mention endorsement of the CONSORT statement although this was not a significant difference (p=0.064). Although there has been a significant improvement in the reporting of trials of operative intervention published in the surgical literature since 2004, items specific to the CONSORT-NPT extension remain underreported. Improved awareness of this important addition to the CONSORT statement throughout the surgical community and its endorsement by surgical journals will help to improve the reporting practice of trials of operative intervention.

  20. Clinical Trials

    Medline Plus

    Full Text Available ... doing screening tests, such as mammography; and compare two or more screening tests to see which test ... and Blood Institute (NHLBI) sponsored a trial of two different combinations of asthma treatments. The trial found ...

  1. Clinical Trials

    Science.gov (United States)

    Clinical trials are research studies that test how well new medical approaches work in people. Each study answers ... prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to a ...

  2. A Randomized Controlled Trial Comparing Behavioral, Educational, and Pharmacological Treatments in Youths With Chronic Tic Disorder or Tourette Syndrome.

    Science.gov (United States)

    Rizzo, Renata; Pellico, Alessandra; Silvestri, Paola Rosaria; Chiarotti, Flavia; Cardona, Francesco

    2018-01-01

    The existing literature on the treatment of pediatric chronic tic disorder (CTD) and Tourette syndrome (TS) indicates that both behavioral therapy (BT) and pharmacotherapy (PT) are effective for reducing symptoms. To evaluate the efficacy of BT compared to psychoeducation (PE) or PT for reducing tics and co-occurring symptoms and for improving quality of life (QoL) in a sample of youths with CTD and TS. A 10 weeks, 2 sites (Catania, Rome) randomized controlled trial. Participants were randomized to receive one of the following treatments: BT, PE, or PT. 110 outpatients aged between 8 and 17 years affected by CTD or TS. Patients in the BT and PT groups showed a significant reduction in the severity of tic symptoms, while the PE group did not show any improvement. PT was more effective for reducing obsessive compulsive symptoms than BT, while PE group did not show any improvement. Both BT and PT groups showed an improvement in most QoL domains, whereas no differences were found in the PE group. BT is as effective as pharmacological therapy in the treatment of tic disorders in children and adolescents, thus offering an alternative to medications for CTD and TS.

  3. Randomized controlled trial comparing a powered toothbrush with distinct multi-directional cleaning action to a manual flat trim toothbrush.

    Science.gov (United States)

    Gallob, John; Mateo, Luis R; Chaknis, Patricia; Morrison, Boyce M; Panagakos, Fotinos

    2015-12-01

    To compare the plaque and gingivitis efficacy of a power toothbrush with distinct multi-directional cleaning action (Colgate® ProClinical® A1500 Power Toothbrush) against a manual flat-trim toothbrush (Oral-B Indicator). This randomized control trial was a single-center, examiner-blind, parallel-group, design and assessed plaque removal after a single brushing, as well as plaque removal and gingivitis reduction after 4 weeks and 12 weeks of brushing. Qualifying subjects used their assigned toothbrush to brush their teeth under supervision after which they were evaluated for plaque (post-brushing). Over the next 12 weeks, subjects brushed unsupervised at home with their assigned toothbrush. After 4 weeks and 12 weeks, subjects returned to the center for plaque and gingivitis examinations. 80 subjects were screened for eligibility and randomized into the study. 79 subjects completed the study. Both toothbrushes provided statistically significant reductions in all plaque index scores at all time points in comparison to the pre-brushing scores. After 4 weeks and 12 weeks, statistically significant reductions in gingivitis and gingivitis severity scores were observed for subjects using the power toothbrush, whereas statistically significant increases in gingivitis and gingivitis severity were observed for subjects using the manual toothbrush. In conclusion, relative to the manual toothbrush, the power toothbrush provided statistically significantly (P toothbrush, the power toothbrush with distinct multi-directional cleaning action demonstrates statistically and clinically significantly greater levels of plaque removal and gingivitis reduction at all time points.

  4. How Effective and Safe Is Bronchial Thermoplasty in "Real Life" Asthmatics Compared to Those Enrolled in Randomized Clinical Trials?

    Science.gov (United States)

    Arrigo, Rita; Failla, Giuseppe; Scichilone, Nicola; La Sala, Alba; Galeone, Carla; Battaglia, Salvatore; Benfante, Alida; Facciolongo, Nicola

    There is limited information on the efficacy and safety of bronchial thermoplasty (BT) in real life . We evaluated the outcomes of the randomized clinical trials for BT in severe asthmatics, in whom the exclusion criteria were not strictly controlled. A case series of seven asthmatics (M/F: 4/3; age: 54.6 ± 2.9 years) is reported. Subjects had a statistically significant improvement in AQLQ (from a mean of 3.96 ± 1.1 to 4.5 ± 1.2 and 5.5 ± 0.6 after 6 and 12 months of treatment; p = 0.0007) and in the ACQ score (from 2.77 ± 0.8 to 1.83 ± 1.2 and 1.5 ± 0.8 after 6 and 12 months; p < 0.001). In the year after BT, severe exacerbations, salbutamol use, and OCS use were significantly lower compared with the 1-yr pretreatment period ( p < 0.001). No ED visits and hospitalization occurred in the year after BT. No changes in functional parameters were recorded. Our investigation confirms the safety and efficacy of BT in severe asthmatics in real life settings.

  5. Mebendazole Compared with Secnidazole in the Treatment of Adult Giardiasis: A Randomised, No-Inferiority, Open Clinical Trial

    Directory of Open Access Journals (Sweden)

    Pedro Almirall

    2011-01-01

    Full Text Available To compare the efficacy and safety of mebendazole and secnidazole in the treatment of giardiasis in adult patients, a single-centre, parallel group, open-label, randomized non-inferiority trial was carried out. One-hundred and 26 participants who had symptomatic Giardia mono-infection took part in the study. Direct wet mount and/or Ritchie concentration techniques and physical examinations were conducted at the time of enrolment and at the follow-up visit. The primary outcome measure was parasitological cure, performed at 3, 5, 10 days post-treatment. Negative faecal specimens for Giardia were ensured by the same parasitological techniques. At follow up (day 10 the parasitological cure rate for the per protocol populations was 88.7% (55/62 for MBZ and 91.8% (56/61 for SNZ. For the intention to treat populations the cure rate at the end of treatment was 85.9% (55/64 for MBZ and 90.3% (56/62 for SNZ. Both analyzes showed there was not significant statistical difference between MBZ and SNZ treatment efficacy. Both drugs were well tolerated, only mild, transient and self-limited side effects were reported and did not require discontinuation of treatment. A 3-day course of mebendazole seems to be as efficacious and safe for treatment of giardiasis as a single dose of secnidazole in adults.

  6. How does routinely delivered cognitive-behavioural therapy for gambling disorder compare to "gold standard" clinical trial?

    Science.gov (United States)

    Smith, David P; Fairweather-Schmidt, A Kate; Harvey, Peter W; Battersby, Malcolm W

    2018-03-01

    Currently, it is unknown whether treatment outcomes derived from randomized controlled trials (RCTs) of cognitive-behavioural therapy (CBT) for problem gamblers still hold when applied to patients seen in routine practice. Thus, data from an RCT of cognitive therapy versus exposure therapy for problem gambling versus patients of a gambling help service were compared. Assessments of problem gambling severity, psychosocial impairment, and alcohol use were undertaken at baseline and post-treatment and evaluated within a counterfactual framework. Findings showed that the contrast between routine CBT for pokies and horse betting had a significant effect, indicative of a 62% lower gambling urge score if routine CBT recipients had all been horse/track betters opposed to gambling with "pokies." However, the majority of contrasts indicated therapeutic outcomes achieved in routine CBT treatments were of equivalent robustness relative to RCT conditions. The present findings infer routine practice treatment outcomes are as efficacious as those generated in RCT contexts. Copyright © 2017 John Wiley & Sons, Ltd.

  7. Low-dose oral isotretinoin for moderate to severe seborrhea and seborrheic dermatitis: a randomized comparative trial.

    Science.gov (United States)

    de Souza Leão Kamamoto, Cristhine; Sanudo, Adriana; Hassun, Karime M; Bagatin, Ediléia

    2017-01-01

    The efficacy of low-dose oral isotretinoin in the treatment of seborrhea and seborrheic dermatitis has been poorly investigated in randomized studies. This study was designed to determine the efficacy and safety of low-dose oral isotretinoin in the treatment of moderate to severe seborrhea and seborrheic dermatitis on the scalp and/or face. A randomized, comparative clinical trial, using two groups, was conducted over 6 months. Patients in Group ISO were treated with isotretinoin 10 mg every other day. In Group X, patients received antiseborrheic topical treatment. Patient opinion, investigator assessment, scalp pruritus, sebum production, and quality of life (QoL) comprised the efficacy outcomes. The intention-to-treat population comprised a total of 45 patients with mean ± standard deviation ages of 28.7 ± 5.8 years in Group ISO and 29.8 ± 6.5 years in Group X. The rate of sebum production significantly decreased in Group ISO. Patient opinion, investigator, and QoL assessments improved in both groups. Low-dose oral isotretinoin can be a therapeutic modality for moderate to severe seborrhea and seborrheic dermatitis. © 2016 The International Society of Dermatology.

  8. A double blind randomized control trial, comparing effect of drospirenone and gestodene to sexual desire and libido.

    Science.gov (United States)

    Oranratanaphan, Shina; Taneepanichskul, Surasak

    2006-10-01

    Oral contraceptive is the most commonly used method of fertility control. Yasmin is a combination of a novel progestogen with anti-androgenic and anti-mineralcorticoid activities (3 mg Drospirenone (DRSP) and 30 microg ethinylestradiol (EE)). It has been shown in many clinical trials that Yasmin is an efficacious oral contraceptive, lacking undesired effects as with other oral contraceptives such as weight gain. However the effects of Yasmin on sexual desire and libido have not been intensively investigated so far Investigate the effects of Yasmin on sexual desire, libido and changes in the free androgen index (FAI) compare to Meliane (75 microg gestodene + 20 microg ethinylestradiol). The authors' report the results of a double blind randomized controlled study using a translated version of the Female Sexual Function Index questionnaire (FSFI) for the assessment of the sexual function. The free androgen index was calculated from measurements of testosterone and sexual hormone binding globulin. The result shows statistically significant improvements regarding sexual desire, arousal and overall satisfaction in the Yasmin group. Additionally, an increased frequency of orgasms in the Meliane group was reported. Statistically significant differences between the two treatments regarding changes in the FSFI score and changes in the free androgen index have not been observed. The novel oral contraceptive containing drospirenone (Yasmin) and the non-anti-androgenic progestin containing oral contraceptive (Meliane) do not show unfavorable effects on sexual response and libido.

  9. Randomized Controlled Trial Comparing Orthosis Augmented by Either Stretching or Stretching and Strengthening for Stage II Tibialis Posterior Tendon Dysfunction.

    Science.gov (United States)

    Houck, Jeff; Neville, Christopher; Tome, Josh; Flemister, Adolph

    2015-09-01

    The value of strengthening and stretching exercises combined with orthosis treatment in a home-based program has not been evaluated. The purpose of this study was to compare the effects of augmenting orthosis treatment with either stretching or a combination of stretching and strengthening in participants with stage II tibialis posterior tendon dysfunction (TPTD). Participants included 39 patients with stage II TPTD who were recruited from a medical center and then randomly assigned to a strengthening or stretching treatment group. Excluding 3 dropouts, there were 19 participants in the strengthening group and 17 in the stretching group. The stretching treatment consisted of a prefabricated orthosis used in conjunction with stretching exercises. The strengthening treatment consisted of a prefabricated orthosis used in conjunction with the stretching and strengthening exercises. The main outcome measures were self-report (ie, Foot Function Index and Short Musculoskeletal Function Assessment) and isometric deep posterior compartment strength. Two-way analysis of variance was used to test for differences between groups at 6 and 12 weeks after starting the exercise programs. Both groups significantly improved in pain and function over the 12-week trial period. The self-report measures showed minimal differences between the treatment groups. There were no differences in isometric deep posterior compartment strength. A moderate-intensity, home-based exercise program was minimally effective in augmenting orthosis wear alone in participants with stage II TPTD. Level I, prospective randomized study. © The Author(s) 2015.

  10. Elective repeat cesarean delivery compared with trial of labor after a prior cesarean delivery: a propensity score analysis.

    Science.gov (United States)

    Kok, N; Ruiter, L; Lindeboom, R; de Groot, C; Pajkrt, E; Mol, B W; Kazemier, B M

    2015-12-01

    To determine neonatal and short term maternal outcomes according to intentional mode of delivery following a cesarean delivery (CD). Women pregnant after CD between January 2000 and December 2007 were categorized according to whether they had an elective repeat CD (ERCD) or a Trial of Labor (TOL). Prognostically equal ERCD and TOL groups were created using the propensity score matching technique. Conditional logistic regression was performed to assess differences in neonatal and maternal outcomes. Women in their second ongoing pregnancy with a history of CD. After ERCD the rates of low 5min Apgar score (OR 0.3, 95%CI 0.2-0.5, p<0.001), meconium aspiration (OR 0.0, 95%CI 0-0.7, p=0.02) and birth trauma (OR 0.08, 95%CI 0.002-0.5, p<0.001) were lower compared to TOL. The rate of transient tachypnoea of the newborn (TTN) appears higher in the ERCD group (OR 1.7, 95%CI 1.0-2.8, p=0.04). Uterine rupture (OR 0.1, 95%CI 0.003-0.8, p=0.02) and hemorrhage (OR 0.6, 95%CI 0.5-0.8, p<0.001) occurred less in the ERCD group. Neonatal and short term maternal morbidity appears to be lower after ERCD than after TOL. Only TTN was seen more often after ERCD. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  11. Adherence to isoniazid prophylaxis among HIV-infected children: a randomized controlled trial comparing two dosing schedules.

    Science.gov (United States)

    le Roux, Stanzi M; Cotton, Mark F; Golub, Jonathan E; le Roux, David M; Workman, Lesley; Zar, Heather J

    2009-11-03

    Tuberculosis contributes significantly to morbidity and mortality among HIV-infected children in sub-Saharan Africa. Isoniazid prophylaxis can reduce tuberculosis incidence in this population. However, for the treatment to be effective, adherence to the medication must be optimized. We investigated adherence to isoniazid prophylaxis administered daily, compared to three times a week, and predictors of adherence amongst HIV-infected children. We investigated adherence to study medication in a two centre, randomized trial comparing daily to three times a week dosing of isoniazid. The study was conducted at two tertiary paediatric care centres in Cape Town, South Africa. Over a 5 year period, we followed 324 HIV-infected children aged >or= 8 weeks. Adherence information based on pill counts was available for 276 children. Percentage adherence was calculated by counting the number of pills returned. Adherence >or= 90% was considered to be optimal. Analysis was done using summary and repeated measures, comparing adherence to the two dosing schedules. Mean percentage adherence (per child during follow-up time) was used to compare the mean of each group as well as the proportion of children achieving an adherence of >or= 90% in each group. For repeated measures, percentage adherence (per child per visit) was dichotomized at 90%. A logistic regression model with generalized estimating equations, to account for within-individual correlation, was used to evaluate the impact of the dosing schedule. Adjustments were made for potential confounders and we assessed potential baseline and time-varying adherence determinants. The overall adherence to isoniazid was excellent, with a mean adherence of 94.7% (95% confidence interval [CI] 93.5-95.9); similar mean adherence was achieved by the group taking daily medication (93.8%; 95% CI 92.1-95.6) and by the three times a week group (95.5%; 95% CI 93.8-97.2). Two-hundred and seventeen (78.6%) children achieved a mean adherence of >or

  12. Effect of lactic acid suppositories compared with oral metronidazole and placebo in bacterial vaginosis: a randomised clinical trial.

    Science.gov (United States)

    Boeke, A J; Dekker, J H; van Eijk, J T; Kostense, P J; Bezemer, P D

    1993-01-01

    OBJECTIVE--To compare the effect of lactic acid locally, metronidazole orally and placebo in women with bacterial vaginosis. DESIGN--Randomised clinical trial. SETTING--30 general practices in the Netherlands. PATIENTS--125 women consulting the general practitioner for symptomatic bacterial vaginosis. MAIN OUTCOME MEASURES--Duration of subjective symptoms, recurrence of symptoms, clinically diagnosed cure, adverse events. RESULTS--Survival analysis showed a significantly faster disappearance of symptoms in the metronidazole category compared with both lactic acid and placebo (p = 0.0005 metronidazole v placebo, p = 0.0002 metronidazole v lactic acid p = 0.6521 lactic acid v placebo [The stratified Mantel Cox test]). The median duration until absence of symptoms was 21 days for metronidazole and 80 days for placebo. Disappearance of symptoms did not occur in 50% of the lactic acid group in 90 days. Recurrence rates of symptoms were similar over the treatment categories (p = 0.13 metronidazole v placebo and p = 0.12 lactic acid v placebo). After 2 weeks cure rates (cure defined as less than three of four clinical criteria present) were 83%, 49% and 47% for metronidazole, lactic acid and placebo category respectively. At that time cure rates (cure defined as none of three clinical criteria present) were 10%, 0% and 3%. After four weeks and three months these figures were: 55%, 20%, 20% and 64%, 28%, 28%. No differences in adverse events were found between the three interventions. CONCLUSIONS--Lactic acid suppositories are ineffective, metronidazole capsules are effective on signs and symptoms in bacterial vaginosis. A considerable proportion of the patients recover without active medication. PMID:8244360

  13. Cavity disinfection in minimally invasive dentistry - comparative evaluation of Aloe vera and propolis: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    A R Prabhakar

    2015-01-01

    Full Text Available Context: The survival of atraumatic restorative treatment (ART restorations would probably increase if near total elimination of cariogenic microorganisms could be done in the process of cavity cleaning before going ahead with the restoration. Thus, use of naturally occurring disinfecting agents for achieving this goal could herald a new beginning in the field of contemporary minimum intervention dentistry. Aims: To evaluate the efficacy of hand instruments in excavating dental caries and comparatively evaluate the roles of Aloe vera and propolis as potential cavity disinfecting agents after minimally invasive hand excavation of dental caries. Settings and Designs: Experimental, in vivo intergroup split mouth, randomized clinical trial. Subjects and Methods: The study included Group I (Control, Group II (A. vera and Group III (propolis. Ten patients with three teeth each have occlusal/occlusoproximal lesions suitable for ART were selected. Dentinal samples were collected three times from each tooth viz., preexcavation, postexcavation and postdisinfection of the cavities. These dentinal samples were subjected to microbiological analyses for total viable count. Statistical Analysis Used: Repeated measures of analysis of variance (ANOVA with Bonferroni post-hoc test and one-way ANOVA with Tukey post-hoc test. Results: In all the three groups, significant amount of bacteria were left behind after hand excavation. Group II and Group III, in which cavities were treated with A. vera and propolis extracts respectively, showed a significant reduction in the bacterial counts when compared to control the group. Conclusions: Hand excavation alone does not completely eliminate bacteria, which may predispose treated teeth to secondary caries. Both propolis and A. vera extracts can be used as potential natural disinfecting agents, thereby embracing the concept of phytotherapy in minimum intervention dentistry.

  14. Randomized controlled trial to compare the effect of simple distraction interventions on pain and anxiety experienced during conscious surgery.

    Science.gov (United States)

    Hudson, B F; Ogden, J; Whiteley, M S

    2015-11-01

    High levels of anxiety during surgery are associated with poorer post-surgical outcomes. This prospective, non-blinded randomized controlled trial aimed to compare the effectiveness of four intraoperative distraction interventions for anxiety and pain management during minimally invasive venous surgery under local anaesthetic. 407 patients presenting with varicose veins at a private clinic, were randomized to one of four intraoperative distraction interventions or treatment as usual. All participants received endovenous thermoablation and/or phlebectomies of varicose veins. After losses to follow-up, 398 participants were entered into the analysis. Participants were randomly allocated to one of the following intraoperative distraction techniques: patient selected music (n = 85), patient selected DVD (n = 85), interaction with nurses (n = 81), touch (stress balls) (n = 80) or treatment as usual (TAU, n = 76). The state scale of the STAI, the Short-form McGill pain questionnaire and numeric rating scales were used to assess intraoperative pain and anxiety. Intraoperative anxiety ratings were significantly lower when participants interacted with nurses, used stress balls or watched a DVD during surgery compared to treatment as usual. Intraoperative pain ratings were significantly lower than treatment as usual when participants interacted with nurses or used stress balls during surgery. Patients' satisfaction was not significantly impacted by intraoperative distractions. The use of simple intraoperative distraction techniques, particularly interacting with nurses, using stress balls or watching a DVD during surgery conducted under local anaesthetic can significantly improve patients' experiences. © 2015 European Pain Federation - EFIC®

  15. Comparative trial of Aloe vera/olive oil combination cream versus phenytoin cream in the treatment of chronic wounds.

    Science.gov (United States)

    Panahi, Y; Izadi, M; Sayyadi, N; Rezaee, R; Jonaidi-Jafari, N; Beiraghdar, F; Zamani, A; Sahebkar, A

    2015-10-01

    Aloe vera is a medicinal plant that has been traditionally used to accelerate wound healing. Olive oil is also a natural product that may contribute to wound healing owing to its antimicrobial and anti-inflammatory effects. The present study aimed to evaluate the effect of an Aloe vera-olive oil (AVO) combination cream on the healing process of chronic wounds. In this randomised, double-blind, comparator-controlled, parallel-group trial, patients with chronic wounds were treated with either AVO cream or phenytoin cream as the standard treatment for a period of 30 days. Wound healing was evaluated using Bates-Jensen assessment tool and the severity of pain was assessed using a visual analogue scale (VAS). After initial assessment, 60 patients with chronic wounds (41 with pressure ulcer, 13 with diabetic wounds and 6 with venous ulcers), were recruited and randomised into 2 groups of 30. After 30 days of treatment, significant improvements in the wound size, depth, and edges; necrotic tissue type and amount; exudate type and amount; colour of wound surroundings; and peripheral tissue oedema score were observed in the AVO cream group (p<0.001). The total score of wound healing showed significant improvement with both AVO (p<0.001) and phenytoin (p<0.01) creams, although AVO was more efficacious (p<0.001). Likewise, although both treatments reduced the initial VAS score, the efficacy of AVO was significantly greater (p<0.001). AVO cream significantly accelerates biological healing of chronic wounds and helps to reduce pain severity with a higher efficacy compared with phenytoin cream.

  16. Interpreting the improved outcome of patients with central nervous system metastases managed in clinical trials compared with standard hospital practice

    International Nuclear Information System (INIS)

    Tang, J.I; Back, M.; Shakespeare, T.; Lu, J.J.; Mukherjee, R.; Wynne, C.

    2005-01-01

    The aims were to determine the median survival and prognostic factors of patients with central nervous system (CNS) metastases managed with whole-brain radiation therapy (WBRT), and to explore selection criteria in recently published clinical trials using aggressive interventions in CNS metastases. A retrospective audit was performed on patients managed with WBRT for CNS metastases. Potential prognostic factors were recorded and analysed for their association with survival duration. The proportion of patients with these factors was also compared with those of patients managed under three recently reported studies investigating aggressive interventions, such as radiosurgery and chemotherapy for CNS metastases. Seventy-three patients were treated with WBRT for cerebral metastases over a 12-month period. The median survival of the population was 3.4 months (95% confidence interval: 2.7-4.1), with 6- and 12-month survival rates of 30 and 18%, respectively. Significant prognostic factors for prolonged median survival were Eastern Cooperative Oncology Group status 0-2 (P = 0.015), Medical Research Council neurological functional status 0-1 (P = 0.006), and Recursive Partitioning Analysis Class 2 versus Class 3 (P = 0.020). On multivariate analysis, younger patient age (P = 0.02) and better performance status (P<0.01) were associated with improved outcome. When comparing these characteristics with selected published studies, our study cohort demonstrated a higher proportion of patients with poor performance status, a greater number of metastases per patient and a higher incidence of extracranial disease. This reflects the selected nature of patients in these published studies. Central nervous system metastases confer a poor prognosis and, for the majority of patients, aggressive interventions are unlikely to improve survival. The use of potentially toxic and expensive treatments should be reserved for those few in whom these studies have shown a potential benefit

  17. Bacterial endogenous endophthalmitis in Vietnam: a randomized controlled trial comparing vitrectomy with silicone oil versus vitrectomy alone

    Directory of Open Access Journals (Sweden)

    Do T

    2014-08-01

    Full Text Available Tan Do,1 Do N Hon,1 Tin Aung,2 Nguyen DTN Hien,1 Claude L Cowan Jr3 1Vietnam National Institute of Ophthalmology, Hanoi, Vietnam; 2Singapore National Eye Center, Singapore; 3Georgetown University Medical Center, Washington, DC, USA Background/aims: To compare treatment outcomes with and without silicone oil tamponade in patients undergoing pars plana vitrectomy (PPV for severe endogenous bacterial endophthalmitis (BEE. Methods: One hundred and eight consecutive patients with severe BEE (defined by the absence of pupil red reflex at presentation and/or dense vitreous opacity on ultrasound and no improvement after 24–36 hours of medical treatment were randomly assigned to two treatment groups: Group 1, standard PPV with intravitreal antibiotics; and Group 2, PPV with intravitreal antibiotics and silicone tamponade. Overall success was defined as: a visual acuity ≥ count fingers at 1 meter, with an attached retina, and no intraocular oil. Results: Fifty three patients were randomized to Group 1 and 55 patients to Group 2. The mean age of study subjects was 32 years and baseline clinical characteristics were similar in both groups. At the final follow-up visit at 9 months, the overall success rate of Group 2 (67.3% was significantly better than Group 1 (43.4%; P=0.01. There were also fewer devastating complications (such as inoperable retinal detachment, phthisis bulbi in Group 2 compared with Group 1 (21.8% versus 43.4%; P=0.01. Conclusion: The outcome at 9 months of patients with BEE treated by vitrectomy with silicone oil was better than those treated by vitrectomy alone. Keywords: bacterial endogenous endophthalmitis, vitrectomy, silicone oil endotamponade, randomized controlled trial

  18. Comparative double blind clinical trial of phenytoin and sodium valproate as anticonvulsant prophylaxis after craniotomy: efficacy, tolerability, and cognitive effects.

    Science.gov (United States)

    Beenen, L F; Lindeboom, J; Kasteleijn-Nolst Trenité, D G; Heimans, J J; Snoek, F J; Touw, D J; Adèr, H J; van Alphen, H A

    1999-10-01

    To determine the efficacy, tolerability, and impact on quality of life and cognitive functioning of anticonvulsant prophylaxis with phenytoin or sodium valproate in patients after craniotomy. A prospective, stratified, randomised, double blind single centre clinical trial was performed, comparing two groups of 50 patients each, who underwent craniotomy for different pathological conditions and who were treated for 1 year after surgery with either 300 mg phenytoin/day or 1500 mg sodium valproate/day. During the study period patients were seen in the outpatient clinic at 1.5, 3, 6, and 12 months, when medical history, adverse events, and drug plasma concentrations were evaluated. Neuropsychological functioning and quality of life were assessed on the last three visits. In cases of a seizure an EEG was performed, drug plasma concentration assessed, and medication subsequently increased. Of the 100 included patients 14 (seven in each group) experienced one or more postoperative seizures. Severity of the seizures was comparable in the two groups. In all patients, drug plasma concentrations were in the low or subtherapeutic ranges at the time of the first postoperative seizure. Five patients in the phenytoin group and two in the valproate group had to stop their treatment due to drug related adverse events. Sixty patients completed the 12 month period. Analysis of neuropsychological and quality of life data showed no significant differences. For efficacy, tolerability, impact on cognitive functioning, and quality of life, no major differences were found between phenytoin and valproate prophylaxis. Valproate is an alternative for anticonvulsant prophylaxis in patients after craniotomy.

  19. Comparative effects of snoring sound between two minimally invasive surgeries in the treatment of snoring: a randomized controlled trial.

    Science.gov (United States)

    Lee, Li-Ang; Yu, Jen-Fang; Lo, Yu-Lun; Chen, Ning-Hung; Fang, Tuan-Jen; Huang, Chung-Guei; Cheng, Wen-Nuan; Li, Hsueh-Yu

    2014-01-01

    Minimally invasive surgeries of the soft palate have emerged as a less-invasive treatment for habitual snoring. To date, there is only limited information available comparing the effects of snoring sound between different minimally invasive surgeries in the treatment of habitual snoring. To compare the efficacy of palatal implant and radiofrequency surgery, in the reduction of snoring through subjective evaluation of snoring and objective snoring sound analysis. Thirty patients with habitual snoring due to palatal obstruction (apnea-hypopnea index ≤15, body max index ≤30) were prospectively enrolled and randomized to undergo a single session of palatal implant or temperature-controlled radiofrequency surgery of the soft palate under local anesthesia. Snoring was primarily evaluated by the patient with a 10 cm visual analogue scale (VAS) at baseline and at a 3-month follow-up visit and the change in VAS was the primary outcome. Moreover, life qualities, measured by snore outcomes survey, and full-night snoring sounds, analyzed by a sound analytic program (Snore Map), were also investigated at the same time. Twenty-eight patients completed the study; 14 received palatal implant surgery and 14 underwent radiofrequency surgery. The VAS and snore outcomes survey scores were significantly improved in both groups. However, the good response (postoperative VAS ≤3 or postoperative VAS ≤5 plus snore outcomes survey score ≥60) rate of the palatal implant group was significantly higher than that of the radiofrequency group (79% vs. 29%, P = 0.021). The maximal loudness of low-frequency (40-300 Hz) snores was reduced significantly in the palatal implant group. In addition, the snoring index was significantly reduced in the radiofrequency group. Both palatal implants and a single-stage radiofrequency surgery improve subjective snoring outcomes, but palatal implants have a greater effect on most measures of subjective and objective snoring. Multi

  20. Treating Procrastination Using Cognitive Behavior Therapy: A Pragmatic Randomized Controlled Trial Comparing Treatment Delivered via the Internet or in Groups.

    Science.gov (United States)

    Rozental, Alexander; Forsström, David; Lindner, Philip; Nilsson, Simon; Mårtensson, Lina; Rizzo, Angela; Andersson, Gerhard; Carlbring, Per

    2018-03-01

    Procrastination is a common problem among university students, with at least half of the population reporting great difficulties initiating or completing tasks and assignments. Procrastination can have a negative impact on course grades and the ability to achieve a university degree, but can also lead to psychological distress. Cognitive behavior therapy (CBT) is believed to reduce procrastination, but few studies have investigated its effectiveness in a regular clinical setting. The current study explored its effects using a pragmatic randomized controlled trial comparing treatment delivered during 8 weeks as self-guided CBT via the Internet (ICBT) or as group CBT. In total, 92 university students with severe procrastination were included in the study (registered as a clinical trial on Clinicaltrials.gov: NCT02112383). Outcome measures on procrastination, depression, anxiety, and well-being were distributed at pre- and posttreatment as well as 6-month follow-up. An outcome measure of procrastination was administered weekly. Linear mixed and fixed effects models were calculated, along with improvement and deterioration rates. The results showed large within-group effect sizes on procrastination, Cohen's d of 1.29 for ICBT, 95% Confidence Interval (CI) [0.81, 1.74], and d of 1.24 for group CBT, 95% CI [0.76, 1.70], and small to moderate benefits for depression, anxiety, and well-being. In total, 33.7% were regarded as improved at posttreatment and 46.7% at follow-up. No differences between conditions were observed after the treatment period, however, participants in group CBT continued or maintained their improvement at follow-up, while participants in self-guided ICBT showed some signs of deterioration. The findings from the current study suggest that CBT might be an effective treatment for those struggling with severe procrastination, but that a group format may be better for some to sustain their benefits over time and that the clinical significance of the

  1. A cluster-randomised clinical trial comparing two cardiovascular health education strategies in a child population: the Savinghearts project

    Directory of Open Access Journals (Sweden)

    Sánchez-Gómez Luis

    2012-11-01

    Full Text Available Abstract Background This paper describes a methodology for comparing the effects of an eduentertainment strategy involving a music concert, and a participatory class experience involving the description and making of a healthy breakfast, as educational vehicles for delivering obesity-preventing/cardiovascular health messages to children aged 7–8 years. Methods/design This study will involve a cluster-randomised trial with blinded assessment. The study subjects will be children aged 7–8 years of both sexes attending public primary schools in the Madrid Region. The participating schools (n=30 will be randomly assigned to one of two groups: 1 Group MC, in which the children will attend a music concert that delivers obesity-preventing/cardiovascular health messages, or 2 Group HB, in which the children will attend a participatory class providing the same information but involving the description and making of a healthy breakfast. The main outcome measured will be the increase in the number of correct answers scored on a knowledge questionnaire and in an attitudes test administered before and after the above interventions. The secondary outcome recorded will be the reduction in BMI percentile among children deemed overweight/obese prior to the interventions. The required sample size (number of children was calculated for a comparison of proportions with an α of 0.05 and a β of 0.20, assuming that the Group MC subjects would show values for the measured variables at least 10% higher than those recorded for the subjects of Group HB. Corrections were made for the design effect and assuming a loss to follow-up of 10%. The maximum sample size required will be 2107 children. Data will be analysed using summary measurements for each cluster, both for making estimates and for hypothesis testing. All analyses will be made on an intention-to-treat basis. Discussion The intervention providing the best results could be recommended as part of health

  2. THE RESULTS OF A PHASE III COMPARATIVE CLINICAL TRIAL OF RITUXIMAB (ACELLBIA® AND MABTHERA® IN RHEUMATOID ARTHRITIS (THE BIORA STUDY

    Directory of Open Access Journals (Sweden)

    E. L. Nasonov

    2016-01-01

    Full Text Available The article considers the results of an international multicenter randomized clinical trial of the efficacy and safety of the brand-name drug rituximab (MabThera, a monoclonal antibody against CD20 antigen of B cells, and its biosimi-lar drug (Acellbia® (the BIORA study in patients with rheumatoid arthritis (RA refractory to therapy with tumor necrosis factor-а inhibitors.Objective: to provide evidence for the therapeutic equivalence of Acellbia® and MabThera® and also to assess their interchangeability.Subjects and methods. The trial enrolled adult patients with active seropositive RA, who were randomized into two groups (1:1: 1 the patients who received Acellbia® 1000 mg intravenously on days 1 and 15; 2 those who had MabThera® in a similar way. When RA activity persisted at 24 weeks, there was re-randomization (1:1 with a partial overlap: Group 1 patients were randomized into group AA (the drug of the second therapy cycle was Acellbia® or Group AM (that was MabThera®, the similar methodology was followed in Group 2 (Groups MM and MA. Throughout the study, the patients received methotrexate at a stable dose of 7.5—25 mg/week and folic acid at a dose of 5 mg/week. The follow-up lasted 48 weeks.Results and discussion. 24 weeks after treatment initiation, the ACR20 response was observed in 84.1% of the patients in the Acellbia® group (95% CI, 74.75—90.50 and in 87% in the MabThera® group (95% CI, 77.71—92.79%; p = 0.773, which suggests that the drugs are therapeutically equivalent. In the second phase of the study, the efficiency of therapy remained high; there were no differences in Groups AA/MM, AA/AM and MM/MA. In both phases, the safety profile of the drugs was comparable; the immunogenicity of treatment remained low. The findings suggest that the brand-name MabThera® and its biosimilar drug Acellbia® are equivalent. Switching from the biosimilar drug to the brand-name one and vice versa has no negative impact on treatment

  3. Pain exposure physical therapy (PEPT) compared to conventional treatment in complex regional pain syndrome type 1: a randomised controlled trial

    Science.gov (United States)

    Barnhoorn, Karlijn J; van de Meent, Henk; van Dongen, Robert T M; Klomp, Frank P; Groenewoud, Hans; Samwel, Han; Nijhuis-van der Sanden, Maria W G; Frölke, Jan Paul M; Staal, J Bart

    2015-01-01

    Objective To compare the effectiveness of pain exposure physical therapy (PEPT) with conventional treatment in patients with complex regional pain syndrome type 1 (CRPS-1) in a randomised controlled trial with a blinded assessor. Setting The study was conducted at a level 1 trauma centre in the Netherlands. Participants 56 adult patients with CRPS-1 participated. Three patients were lost to follow-up. Interventions Patients received either PEPT in a maximum of five treatment sessions, or conventional treatment following the Dutch multidisciplinary guideline. Measurements Outcomes were assessed at baseline and at 3, 6 and 9 months after randomisation. The primary outcome measure was the Impairment level Sum Score—Restricted Version (ISS-RV), consisting of visual analogue scale for pain (VAS-pain), McGill Pain Questionnaire, active range of motion (AROM) and skin temperature. Secondary outcome measures included Pain Disability Index (PDI); muscle strength; Short Form 36 (SF-36); disability of arm, shoulder and hand; Lower Limb Tasks Questionnaire (LLTQ); 10 m walk test; timed up-and-go test (TUG) and EuroQol-5D. Results The intention-to-treat analysis showed a clinically relevant decrease in ISS-RV (6.7 points for PEPT and 6.2 points for conventional treatment), but the between-group difference was not significant (0.96, 95% CI −1.56 to 3.48). Participants allocated to PEPT experienced a greater improvement in AROM (between-group difference 0.51, 95% CI 0.07 to 0.94; p=0.02). The per protocol analysis showed larger and significant between-group effects on ISS-RV, VAS-pain, AROM, PDI, SF-36, LLTQ and TUG. Conclusions We cannot conclude that PEPT is superior to conventional treatment for patients with CRPS-1. Further high-quality research on the effects of PEPT is warranted given the potential effects as indicated by the per protocol analysis. Trial registration numbers NCT00817128 and NTR 2090. PMID:26628523

  4. A prospective randomized comparative clinical trial comparing the efficacy between ondansetron and metoclopramide for prevention of nausea and vomiting in patients undergoing fractionated radiotherapy to the abdominal region

    Energy Technology Data Exchange (ETDEWEB)

    Park, Hee Chul; Suh, Chang Ok; Seong, Jin Sil; Cho, Jae Ho; Lim, John Jihoon; Park, Won; Song, Jae Seok; Kim, Gwi Eon [College of Medicine, Yonsei Univ., Seoul (Korea, Republic of)

    2001-06-01

    This study is a prospective randomized clinical trial comparing the efficacy and complication of anti-emetic drugs for prevention of nausea and vomiting after radiotherapy which has moderate emetogenic potential. The aim of this study was to investigate whether the anti-emetic efficacy at ondansetron(Zofran) 8 mg bid dose (Group O) is better than the efficacy of metoclopramide 5 mg tid dose (Group M) in patients undergoing fractionated radiotherapy to the abdominal region. Study entry was restricted to those patients who met the following eligibility criteria: histologically confirmed malignant disease; no distant metastasis; performance status of not more than ECOG grade 2; no previous chemotherapy and radiotherapy. Between March 1997 and February 1998, 60 patients enrolled in this study. All patients signed a written statement of informed consent prior to enrollment. Blinding was maintained by dosing identical number of tables including one dose of matching placebo for Group O. The extent of nausea, appetite loss, and the number of emetic episodes were recorded everyday using diary card. The mean score of nausea, appetite loss and the mean number of emetic episodes were obtained in a weekly interval. Prescription error occurred in one patient. And diary cards have not returned in 3 patients due to premature refusal of treatment. Card from one patient was excluded from the analysis because she had a history of treatment for neurosis. As a result, the analysis consisted of 55 patients. Patient characteristics and radiotherapy characteristics were similar except mean age was 52.9{+-} 11.2 in group M, 46.5{+-}9.6 in group O. The difference of age was statistically significant. The mean score of nausea, appetite loss and emetic episodes in a weekly interval was higher in group M than O. In group M, the symptoms were most significant at 5th week. In a panel data analysis using mixed procedure, treatment group was only significant factor detecting the difference of

  5. A prospective randomized comparative clinical trial comparing the efficacy between ondansetron and metoclopramide for prevention of nausea and vomiting in patients undergoing fractionated radiotherapy to the abdominal region

    International Nuclear Information System (INIS)

    Park, Hee Chul; Suh, Chang Ok; Seong, Jin Sil; Cho, Jae Ho; Lim, John Jihoon; Park, Won; Song, Jae Seok; Kim, Gwi Eon

    2001-01-01

    This study is a prospective randomized clinical trial comparing the efficacy and complication of anti-emetic drugs for prevention of nausea and vomiting after radiotherapy which has moderate emetogenic potential. The aim of this study was to investigate whether the anti-emetic efficacy at ondansetron(Zofran) 8 mg bid dose (Group O) is better than the efficacy of metoclopramide 5 mg tid dose (Group M) in patients undergoing fractionated radiotherapy to the abdominal region. Study entry was restricted to those patients who met the following eligibility criteria: histologically confirmed malignant disease; no distant metastasis; performance status of not more than ECOG grade 2; no previous chemotherapy and radiotherapy. Between March 1997 and February 1998, 60 patients enrolled in this study. All patients signed a written statement of informed consent prior to enrollment. Blinding was maintained by dosing identical number of tables including one dose of matching placebo for Group O. The extent of nausea, appetite loss, and the number of emetic episodes were recorded everyday using diary card. The mean score of nausea, appetite loss and the mean number of emetic episodes were obtained in a weekly interval. Prescription error occurred in one patient. And diary cards have not returned in 3 patients due to premature refusal of treatment. Card from one patient was excluded from the analysis because she had a history of treatment for neurosis. As a result, the analysis consisted of 55 patients. Patient characteristics and radiotherapy characteristics were similar except mean age was 52.9± 11.2 in group M, 46.5±9.6 in group O. The difference of age was statistically significant. The mean score of nausea, appetite loss and emetic episodes in a weekly interval was higher in group M than O. In group M, the symptoms were most significant at 5th week. In a panel data analysis using mixed procedure, treatment group was only significant factor detecting the difference of weekly

  6. Adjuvant chemotherapy with gemcitabine and cisplatin compared to observation after curative intent resection of cholangiocarcinoma and muscle invasive gallbladder carcinoma (ACTICCA-1 trial) - a randomized, multidisciplinary, multinational phase III trial

    DEFF Research Database (Denmark)

    Stein, A.; Arnold, D.; Bridgewater, J.

    2015-01-01

    selected the combination of gemcitabine and cisplatin for 24 weeks as investigational treatment. Based on adjuvant trials in pancreatic cancer with comparable postoperative recovery time, inclusion of patients within a maximum interval of 16 weeks between surgery and start of chemotherapy was stipulated...

  7. Design of a randomized controlled trial to compare debridement to observation of chondral lesions encountered during partial meniscectomy: The ChAMP (Chondral Lesions And Meniscus Procedures) Trial.

    Science.gov (United States)

    Bisson, Leslie J; Kluczynski, Melissa A; Wind, William M; Fineberg, Marc S; Bernas, Geoffrey A; Rauh, Michael A; Marzo, John M; Smolinski, Robert J

    2015-11-01

    Few studies have examined whether chondral lesions encountered in patients undergoing meniscectomy should be surgically treated. The primary aim of the ChAMP (Chondral Lesions And Meniscus Procedures) Trial is to determine whether there is a difference in knee pain between patients undergoing debridement versus observation of chondral lesions encountered during arthroscopic meniscectomy. This paper describes the rationale and study design for the ChAMP Trial. The ChAMP Trial is a randomized controlled trial of patients aged 30 and older undergoing partial meniscectomy and randomly allocated to debridement (CL-Deb, N=98) or observation (CL-Obs, N=92) of chondral lesions identified during surgery and deemed to be significant (Outerbridge Grade II-IV). Patients and data collectors were unaware of treatment allocation until completion of the study. Patients with surgically insignificant (Outerbridge Grade I) chondral lesions or no chondral lesions were included as a third non-randomized comparison group (NoCL, N=76). The primary outcome is the difference in knee pain assessed by WOMAC (Western Ontario and McMaster Universities Arthritis Index) between the CL-Deb and CL-Obs groups at 1-year after surgery. Secondary outcomes include 1-year differences in additional measures of knee pain, function, symptoms, activity, and quality of life assessed by the WOMAC, KOOS (Knee Injury and Osteoarthritis Outcome Score), visual analog pain scale, and physical exam; as well as general health assessed with the SF-36 (Short-form Health Survey). Increased intraoperative costs associated with the addition of chondral debridement will also be assessed. This study will add to the scant literature regarding management of chondral lesions in patients undergoing meniscectomy and might provide treatment guidance for clinicians and their patients. Copyright © 2015 Elsevier Inc. All rights reserved.

  8. Prospective randomized controlled trial comparing the outcomes and costs of two eyecare adherence interventions in diabetes patients.

    Science.gov (United States)

    Pizzi, Laura T; Zangalli, Camila S; Murchison, Ann P; Hale, Nicole; Hark, Lisa; Dai, Yang; Leiby, Benjamin E; Haller, Julia A

    2015-04-01

    Diabetic retinopathy is one of the leading causes of vision impairment among adults in the USA. While it is suggested that diabetics receive annual dilated fundus examinations (DFE), many patients do not adhere to these recommendations. This paper investigates the outcomes and costs of an educational and telephone intervention on DFE follow-up adherence in patients with diabetes. In a prospective trial, 356 diabetic patients due for a DFE at an urban eye clinic were randomly assigned to usual care (UC; reference case), mailed intervention (MI), or telephone intervention (TI). UC patients (n = 119) received a standard form letter. MI patients (n = 117) received a personalized letter encouraging scheduling of an eye examination with an educational brochure about diabetic eye disease. TI patients (n = 120) received personal calls (up to three attempts) to schedule a follow-up with standard form letter. The primary outcome was obtaining a DFE within 90 days of suggested return. Costs (US$ 2013) included time costs for staff, phone charges, supplies, and postage. Since TI involved greater cost components compared to MI, univariate sensitivity analysis examined the impact of reducing phone costs. Patients were mostly female (66 %) and African American (70 %) with a mean age of 61 years. TI patients were more likely to schedule DFE [65 vs. 42 %; relative risk (RR) 1.54; CI 1.20-1.96; P < 0.001] versus UC patients. Obtaining a DFE within 90 days of suggested return was also significantly higher among TI patients compared to UC patients (51 vs. 36 %, RR 1.41; CI 1.05-1.89; P = 0.024). MI patients were slightly less likely to schedule DFE versus UC patients (38 vs. 42 %, RR 0.90; CI 0.66-1.22; P = NSS) and obtain a DFE (32 vs. 36 %; RR 0.90; CI 0.63-1.28; P = NSS). The total cost of TI was US$798.28 or US$6.65/patient and the cost/follow-up DFE was US$26.05. Sensitivity analyses revealed that the cost/follow-up can be greatly reduced but remains

  9. A randomized controlled trial comparing the effects of counseling and alarm device on HAART adherence and virologic outcomes.

    Directory of Open Access Journals (Sweden)

    Michael H Chung

    2011-03-01

    Full Text Available Behavioral interventions that promote adherence to antiretroviral medications may decrease HIV treatment failure. Antiretroviral treatment programs in sub-Saharan Africa confront increasing financial constraints to provide comprehensive HIV care, which include adherence interventions. This study compared the impact of counseling and use of an alarm device on adherence and biological outcomes in a resource-limited setting.A randomized controlled, factorial designed trial was conducted in Nairobi, Kenya. Antiretroviral-naïve individuals initiating free highly active antiretroviral therapy (HAART in the form of fixed-dose combination pills (d4T, 3TC, and nevirapine were randomized to one of four arms: counseling (three counseling sessions around HAART initiation, alarm (pocket electronic pill reminder carried for 6 months, counseling plus alarm, and neither counseling nor alarm. Participants were followed for 18 months after HAART initiation. Primary study endpoints included plasma HIV-1 RNA and CD4 count every 6 months, mortality, and adherence measured by monthly pill count. Between May 2006 and September 2008, 400 individuals were enrolled, 362 initiated HAART, and 310 completed follow-up. Participants who received counseling were 29% less likely to have monthly adherence <80% (hazard ratio [HR] = 0.71; 95% confidence interval [CI] 0.49-1.01; p = 0.055 and 59% less likely to experience viral failure (HIV-1 RNA ≥5,000 copies/ml (HR 0.41; 95% CI 0.21-0.81; p = 0.01 compared to those who received no counseling. There was no significant impact of using an alarm on poor adherence (HR 0.93; 95% CI 0.65-1.32; p = 0.7 or viral failure (HR 0.99; 95% CI 0.53-1.84; p = 1.0 compared to those who did not use an alarm. Neither counseling nor alarm was significantly associated with mortality or rate of immune reconstitution.Intensive early adherence counseling at HAART initiation resulted in sustained, significant impact on adherence and

  10. Comparative double blind clinical trial of phenytoin and sodium valproate as anticonvulsant prophylaxis after craniotomy: efficacy, tolerability, and cognitive effects

    NARCIS (Netherlands)

    Beenen, L. F.; Lindeboom, J.; Kasteleijn-Nolst Trenité, D. G.; Heimans, J. J.; Snoek, F. J.; Touw, D. J.; Adèr, H. J.; van Alphen, H. A.

    1999-01-01

    OBJECTIVE: To determine the efficacy, tolerability, and impact on quality of life and cognitive functioning of anticonvulsant prophylaxis with phenytoin or sodium valproate in patients after craniotomy. METHODS: A prospective, stratified, randomised, double blind single centre clinical trial was

  11. Comparative double blind clinical trial of phenytoin and sodium valproate as anticonvulsant prophylaxis after craniotomy : efficacy, tolerability, and cognitive effects

    NARCIS (Netherlands)

    Beenen, L F; Lindeboom, J; Kasteleijn-Nolst Trenité, D G; Heimans, J J; Snoek, F J; Touw, D J; Adèr, H J; van Alphen, H A

    1999-01-01

    OBJECTIVE: To determine the efficacy, tolerability, and impact on quality of life and cognitive functioning of anticonvulsant prophylaxis with phenytoin or sodium valproate in patients after craniotomy. METHODS: A prospective, stratified, randomised, double blind single centre clinical trial was

  12. Efficacy and Safety of Sparsentan Compared With Irbesartan in Patients With Primary Focal Segmental Glomerulosclerosis: Randomized, Controlled Trial Design (DUET

    Directory of Open Access Journals (Sweden)

    Radko Komers

    2017-07-01

    Discussion: This study will provide important evidence on whether dual ARB and endothelin blockade may be an effective therapeutic strategy for FSGS and may provide the rationale for next-phase trials.

  13. Trial participants' experiences of early enhanced speech and language therapy after stroke compared with employed visitor support: a qualitative study nested within a randomized controlled trial.

    Science.gov (United States)

    Young, Alys; Gomersall, Timothy; Bowen, Audrey

    2013-02-01

    To explore trial participants' experiences of the process and outcomes of early, enhanced speech and language therapy after stroke with support from an employed visitor. Qualitative study nested within a randomized controlled trial. Twney-two people who, after stroke, had a diagnosis of aphasia (12), dysarthria (5) or both (5) and who participated in the ACT NoW study. Eight English NHS usual care settings. Individual interviews. Thematic content analysis assisted by a bespoke data transformation protocol for incorporating non-verbal and semantically ambiguous data. Participants highly regarded regular and sustained contact with someone outside of immediate family/friends who engaged them in deliberate activities/communication in the early months after stroke. Participants identified differences in the process of intervention between speech and language therapists and employed visitors. But no major discriminations were made between the impact or value of this contact according to whether provided by a speech and language therapist or employed visitor. Participant-defined criteria for effectiveness of contact included: impact on mood and confidence, self-recognition of progress and the meeting of individual needs. As in the randomized controlled trial, participants reported no evidence of added benefit of early communication therapy beyond that from attention control. The findings do not imply that regular contact with any non-professional can have beneficial effects for someone with aphasia or dysarthria in the early weeks following a stroke. The study points to specific conditions that would have to be met for contact to have a positive effect.

  14. Cost-effectiveness of induction of labour at term with a Foley catheter compared to vaginal prostaglandin E2 gel (PROBAAT trial)

    NARCIS (Netherlands)

    van Baaren, G. J.; Jozwiak, M.; Opmeer, B. C.; Rengerink, K. Oude; Benthem, M.; Dijksterhuis, M. G. K.; van Huizen, M. E.; van der Salm, P. C. M.; Schuitemaker, N. W. E.; Papatsonis, D. N. M.; Perquin, D. A. M.; Porath, M.; van der Post, J. A. M.; Rijnders, R. J. P.; Scheepers, H. C. J.; Spaanderman, M.; van Pampus, M. G.; de Leeuw, J. W.; Mol, B. W. J.; Bloemenkamp, K. W. M.

    Objective To assess the economic consequences of labour induction with Foley catheter compared to prostaglandin E2 gel. Design Economic evaluation alongside a randomised controlled trial. Setting Obstetric departments of one university and 11 teaching hospitals in the Netherlands. Population Women

  15. Cancer-Related Fatigue and Rehabilitation : A Randomized Controlled Multicenter Trial Comparing Physical Training Combined With Cognitive-Behavioral Therapy With Physical Training Only and With No Intervention

    NARCIS (Netherlands)

    van Weert, E.; May, A.M.; Korstjens, I.; Post, W.J.; van der Schans, C.P.; van den Borne, B.; Mesters, I.; Ros, W.J.G.; Hoekstra-Weebers, J.E.H.M.

    2010-01-01

    Background. Research suggests that cancer rehabilitation reduces fatigue in survivors of cancer. To date, it is unclear what type of rehabilitation is most beneficial. Objective. This randomized controlled trial compared the effect on cancer-related fatigue of physical training combined with

  16. Cancer-related fatigue and rehabilitation: A randomized controlled multicenter trial comparing physical training combined with cognitive-behavioral therapy with physical training only and with no intervention

    NARCIS (Netherlands)

    E. van Weert (Ellen); A.M. May (Anne); I. Korstjens (Irene); W.J. Post (Wendy); C.P. van der Schans (Cees); B. van den Borne (Bart); I. Mesters (Ilse); W.J.G. Ros (Wynand); J.E.H.M. Hoekstra-Weebers (Josette)

    2010-01-01

    textabstractBackground. Research suggests that cancer rehabilitation reduces fatigue in survivors of cancer. To date, it is unclear what type of rehabilitation is most beneficial. Objective. This randomized controlled trial compared the effect on cancerrelated fatigue of physical training combined

  17. Treatment of myogenic temporomandibular disorder: a prospective randomized clinical trial, comparing a mechanical stretching device (TheraBite®) with standard physical therapy exercise

    NARCIS (Netherlands)

    Kraaijenga, Sophie; van der Molen, Lisette; van Tinteren, Harm; Hilgers, Frans; Smeele, Ludi

    2014-01-01

    To compare in a randomized controlled clinical trial (RCT) the application of the TheraBite® (TB) Jaw Motion Rehabilitation System with a standard physical therapy (PT) exercise regimen for the treatment of myogenic temporomandibular disorder (TMD). Myogenic TMD patients were randomized for the use

  18. Treatment of myogenic temporomandibular disorder: a prospective randomized clinical trial, comparing a mechanical stretching device (TheraBite®) with standard physical therapy exercise

    NARCIS (Netherlands)

    Kraaijenga, S.; van der Molen, L.; van Tinteren, H.; Hilgers, F.; Smeele, L.

    2014-01-01

    Aims: To compare in a randomized controlled clinical trial (RCT) the application of the TheraBite® (TB) Jaw Motion Rehabilitation System with a standard physical therapy (PT) exercise regimen for the treatment of myogenic temporomandibular disorder (TMD). Methodology: Myogenic TMD patients were

  19. Intermediate-dose melphalan compared with myeloablative treatment in multiple myeloma : long-term follow-up of the Dutch cooperative group HOVON 24 trial

    NARCIS (Netherlands)

    Sonneveld, Pieter; van der Holt, Bronno; Segeren, Christine M.; Vellenga, Edo; Croockewit, Alexandra J.; Verhoef, Gregor E. G.; Cornelissen, Jan J.; Schaafsma, Martijn R.; van Oers, Marinus H. J.; Wijermans, Pierre W.; Westveer, Petra H. M.; Lokhorst, Henk M.

    Background and Objectives The Dutch-Belgian HOVON group performed a randomized phase 3 trial to compare single non-myeloablative intensive treatment with double, intensive treatment in previously untreated patients with multiple myeloma (MM). Design and Methods Three hundred and three patients with

  20. A randomized controlled trial of 1% aqueous chlorhexidine gluconate compared with 10% povidone-iodine for topical antiseptic in neonates: effects on blood culture contamination rates.

    Science.gov (United States)

    Nuntnarumit, Pracha; Sangsuksawang, Nartsiri

    2013-04-01

    We conducted a randomized controlled trial in neonates with birth weight greater than or equal to 1,500 g that compared 1% aqueous chlorhexidine gluconate (CHG) with 10% povidone-iodine (PI) as a topical antiseptic. We found 1% CHG to be more effective than 1% PI in reducing blood culture contamination rates, and no contact dermatitis was observed.

  1. Five-year extension of a clinical trial comparing the EX-PRESS glaucoma filtration device and trabeculectomy in primary open-angle glaucoma

    NARCIS (Netherlands)

    de Jong, Leo; Lafuma, Antoine; Aguadé, Anne-Sophie; Berdeaux, Gilles

    2011-01-01

    This study compared the efficacy of the EX-PRESS(®) glaucoma filtration device and trabeculectomy in primary open-angle glaucoma up to five years after surgery. Patients from a previously reported randomized, open-label, parallel-arm clinical trial in which 78 patients received either the EX-PRESS

  2. Assignment refusal and its relation to outcome in a randomized controlled trial comparing Cognitive Therapy and Fluvoxamine in treatment-resistant patients with obsessive compulsive disorder

    NARCIS (Netherlands)

    Landsheer, Johannes A.; Smit, Johannes H.; van Oppen, Patricia; van Balkom, Anton J L M

    2015-01-01

    The effectiveness of Fluvoxamine was compared to that of Cognitive Therapy (CT) in a 12-week randomized controlled trial (RCT) in 48 patients with obsessive-compulsive disorder (OCD), who were treatment-resistant to a previous behavior therapy (BT). A considerable amount of patients did not comply

  3. Efficacy and safety of apixaban compared with aspirin in patients who previously tried but failed treatment with vitamin K antagonists: results from the AVERROES trial

    NARCIS (Netherlands)

    Coppens, Michiel; Synhorst, David; Eikelboom, John W.; Yusuf, Salim; Shestakovska, Olga; Connolly, Stuart J.

    2014-01-01

    The AVERROES double-blinded, randomized trial demonstrated that apixaban reduces the risk of stroke or systemic embolism (SSE) by 55% compared with aspirin without an increase in major bleeding in patients with atrial fibrillation either who previously tried but failed vitamin K antagonists (VKA)

  4. Meta-analysis of 14 trials comparing bypass grafting vs drug-eluting stents in diabetic patients with multivessel coronary artery disease

    NARCIS (Netherlands)

    Luca, G. De; Schaffer, A.; Verdoia, M.; Suryapranata, H.

    2014-01-01

    BACKGROUND AND AIM: Clinical trials have reported lower mortality and repeated revascularization rate in diabetic patients treated with coronary artery bypass grafting (CABG) as compared to percutaneous revascularization. However, these studies were conducted in the era of bare-metal stents.

  5. A Randomized Controlled Trial for Children with Childhood Apraxia of Speech Comparing Rapid Syllable Transition Treatment and the Nuffield Dyspraxia Programme-Third Edition

    Science.gov (United States)

    Murray, Elizabeth; McCabe, Patricia; Ballard, Kirrie J.

    2015-01-01

    Purpose: This randomized controlled trial compared the experimental Rapid Syllable Transition (ReST) treatment to the Nuffield Dyspraxia Programme-Third Edition (NDP3; Williams & Stephens, 2004), used widely in clinical practice in Australia and the United Kingdom. Both programs aim to improve speech motor planning/programming for children…

  6. Differences in Blood Pressure in Infants After General Anesthesia Compared to Awake Regional Anesthesia (GAS Study-A Prospective Randomized Trial)

    NARCIS (Netherlands)

    McCann, Mary Ellen; Withington, D E; Arnup, S J; Davidson, A J; Disma, N; Frawley, G; Morton, N S; Bell, G; Hunt, R W; Bellinger, D C; Polaner, D M; Leo, A; Absalom, A R; von Ungern-Sternberg, B S; Izzo, F; Szmuk, P; Young, V; Soriano, S G; de Graaff, J C

    BACKGROUND: The General Anesthesia compared to Spinal anesthesia (GAS) study is a prospective randomized, controlled, multisite, trial designed to assess the influence of general anesthesia (GA) on neurodevelopment at 5 years of age. A secondary aim obtained from the blood pressure data of the GAS

  7. Effect of pelvic floor muscle training compared with watchful waiting in older women with symptomatic mild pelvic organ prolapse : randomised controlled trial in primary care

    NARCIS (Netherlands)

    Wiegersma, Marian; Panman, Chantal M. C. R.; Kollen, Boudewijn J.; Berger, Marjolein Y.; Lisman-Van Leeuwen, Yvonne; Dekker, Janny H.

    2014-01-01

    Objective To compare the effects of pelvic floor muscle training and watchful waiting on pelvic floor symptoms in a primary care population of women aged 55 years and over with symptomatic mild pelvic organ prolapse. Design Randomised controlled trial. Setting Dutch primary care. Participants Women

  8. Maternal Efficacy and Safety Outcomes in a Randomized, Controlled Trial Comparing Insulin Detemir With NPH Insulin in 310 Pregnant Women With Type 1 Diabetes

    DEFF Research Database (Denmark)

    Mathiesen, Elisabeth R; Hod, Moshe; Ivanisevic, Marina

    2012-01-01

    OBJECTIVE This randomized, controlled noninferiority trial aimed to compare the efficacy and safety of insulin detemir (IDet) versus neutral protamine Hagedorn (NPH) (both with prandial insulin aspart) in pregnant women with type 1 diabetes. RESEARCH DESIGN AND METHODS Patients were randomized an...

  9. Characteristics of children and young adults with Marfan syndrome and aortic root dilation in a randomized trial comparing atenolol and losartan therapy

    NARCIS (Netherlands)

    Lacro, R.V.; Guey, L.T.; Dietz, H.C.; Pearson, G.D.; Yetman, A.T.; Gelb, B.D.; Loeys, B.L.; Benson, D.W.; Bradley, T.J.; Backer, J. de; Forbus, G.A.; Klein, G.L.; Lai, W.W.; Levine, J.C.; Lewin, M.B.; Markham, L.W.; Paridon, S.M.; Pierpont, M.E.; Radojewski, E.; Selamet Tierney, E.S.; Sharkey, A.M.; Wechsler, S.B.; Mahony, L.; et al.,

    2013-01-01

    BACKGROUND: The Pediatric Heart Network designed a clinical trial to compare aortic root growth and other short-term cardiovascular outcomes in children and young adults with Marfan syndrome randomized to receive atenolol or losartan. We report here the characteristics of the screened population and

  10. Comparably improved health-related quality of life after total arterial revascularization versus conventional coronary surgery--Copenhagen arterial revascularization randomized patency and outcome trial

    DEFF Research Database (Denmark)

    Damgaard, Sune; Lund, Jens T; Lilleør, Nikolaj B

    2011-01-01

    OBJECTIVE: We compared health-related quality of life up to 11 months after coronary artery bypass grafting using total arterial revascularization versus conventional coronary surgery. METHODS: In this randomized single-center trial, 161 patients underwent total arterial revascularization using s...

  11. Quality of life after self-management cancer rehabilitation : A Randomized controlled trial comparing physical and cognitive-behavioral training versus physical training

    NARCIS (Netherlands)

    Korstjens, Irene; May, Anne M.; van Weert, Ellen; Mesters, Ilse; Tan, Frans; Ros, Wynand J. G.; Hoekstra-Weebers, Josette E. H. M.; van der Schans, Cees P.; van den Borne, Bart

    Objective: To conduct a randomized controlled trial and compare the effects on cancer survivors' quality of life in a 12-week group-based multidisciplinary self-management rehabilitation program, combining physical training (twice weekly) and cognitive-behavioral training (once weekly) with those of

  12. Economic analysis comparing induction of labor and expectant management in women with preterm prelabor rupture of membranes between 34 and 37 weeks (PPROMEXIL trial)

    NARCIS (Netherlands)

    Vijgen, S.M.; Ham, D.P. van der; Bijlenga, D.; Beek, J.J. van; Bloemenkamp, K.W.; Kwee, A.; Groenewout, M.; Kars, M.M.; Kuppens, S.; Mantel, G.; Molkenboer, J.F.; Mulder, A.L.; Nijhuis, J.G.; Pernet, P.J.; Porath, M.; Woiski, M.D.; Weinans, M.J.; Wijngaarden, W.J. van; Wildschut, H.I.J.; Akerboom, B.; Sikkema, J.M.; Willekes, C.; Mol, B.W.; Opmeer, B.C.; et al.,

    2014-01-01

    OBJECTIVE: To compare the costs of induction of labor and expectant management in women with preterm prelabor rupture of membranes (PPROM). DESIGN: Economic analysis based on a randomized clinical trial. SETTING: Obstetric departments of eight academic and 52 non-academic hospitals in the

  13. Economic analysis comparing induction of labor and expectant management in women with preterm prelabor rupture of membranes between 34 and 37 weeks (PPROMEXIL trial)

    NARCIS (Netherlands)

    Vijgen, Sylvia M. C.; Van der Ham, David P.; Bijlenga, Denise; Van Beek, Johannes J.; Bloemenkamp, Kitty W. M.; Kwee, Anneke; Groenewout, Mariet; Kars, Michael M.; Kuppens, Simone; Mantel, Gerald; Molkenboer, Jan F. M.; Mulder, Antonius L. M.; Nijhuis, Jan G.; Pernet, Paula J. M.; Porath, Martina; Woiski, Mallory D.; Weinans, Martin J. N.; Van Wijngaarden, Wim J.; Wildschut, Hajo I. J.; Akerboom, Bertina; Sikkema, J. Marko; Willekes, Christine; Mol, Ben W. J.; Opmeer, Brent C.

    ObjectiveTo compare the costs of induction of labor and expectant management in women with preterm prelabor rupture of membranes (PPROM). DesignEconomic analysis based on a randomized clinical trial. SettingObstetric departments of eight academic and 52 non-academic hospitals in the Netherlands.

  14. Economic analysis comparing induction of labor and expectant management in women with preterm prelabor rupture of membranes between 34 and 37 weeks (PPROMEXIL trial)

    NARCIS (Netherlands)

    Vijgen, Sylvia M. C.; van der Ham, David P.; Bijlenga, Denise; van Beek, Johannes J.; Bloemenkamp, Kitty W. M.; Kwee, Anneke; Groenewout, Mariët; Kars, Michael M.; Kuppens, Simone; Mantel, Gerald; Molkenboer, Jan F. M.; Mulder, Antonius L. M.; Nijhuis, Jan G.; Pernet, Paula J. M.; Porath, Martina; Woiski, Mallory D.; Weinans, Martin J. N.; van Wijngaarden, Wim J.; Wildschut, Hajo I. J.; Akerboom, Bertina; Sikkema, J. Marko; Willekes, Christine; Mol, Ben W. J.; Opmeer, Brent C.

    2014-01-01

    To compare the costs of induction of labor and expectant management in women with preterm prelabor rupture of membranes (PPROM). Economic analysis based on a randomized clinical trial. Obstetric departments of eight academic and 52 non-academic hospitals in the Netherlands. Women with PPROM near

  15. A comparative study between a simplified Kalman filter and Sliding Window Averaging for single trial dynamical estimation of event-related potentials

    DEFF Research Database (Denmark)

    Vedel-Larsen, Esben; Fuglø, Jacob; Channir, Fouad

    2010-01-01

    , are variable and depend on cognitive function. This study compares the performance of a simplified Kalman filter with Sliding Window Averaging in tracking dynamical changes in single trial P300. The comparison is performed on simulated P300 data with added background noise consisting of both simulated and real...

  16. Comparative lipid-lowering effects of policosanol and atorvastatin: a randomized, parallel, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Cubeddu, Luigi X; Cubeddu, Roberto J; Heimowitz, Todd; Restrepo, Beatriz; Lamas, Gervasio A; Weinberg, Gloria B

    2006-11-01

    Policosanol, commonly derived from purified sugar cane wax, has been reported to exert lipid-lowering effects. Policosanol is available in the United States as a nutritional supplement despite no US research clinical experience. This trial was designed to rigorously establish the lipid-lowering efficacy of policosanol as monotherapy and its potential additive and possibly synergistic effects when added to statin therapy. A randomized, parallel, double-blind, double-dummy, placebo-controlled design was used. Patients with low-density lipoprotein cholesterol (LDL-C) levels from 140 to 189 mg/dL were assigned into 1 of 4 groups to receive policosanol 20 mg, atorvastatin 10 mg, combination therapy, or placebo for 12 weeks. A total of 99 patients were examined. Baseline characteristics were similar among all treatment groups. Policosanol (20 mg/d for 12 weeks) did not significantly change plasma total cholesterol, LDL-C, high-density lipoprotein cholesterol, or triglyceride levels when compared with baseline values or with values of placebo-treated patients. Atorvastatin (10 mg/d for 12 weeks) reduced total cholesterol by 27% and LDL-C by 35%. Addition of policosanol to atorvastatin failed to produce any further reduction in lipid levels above that of atorvastatin alone. Policosanol was safe and did not affect liver enzyme or creatinine phosphokinase levels. Policosanol did not reduce LDL-C or total cholesterol levels either alone or in combination with atorvastatin. This observation supports the need for systematic evaluation of available products containing policosanol to determine their clinical lipid-lowering efficacy under rigorous experimental conditions. We propose that policosanol should be added to the list of nutritional supplements lacking scientific validity to support their use.

  17. Comparing Transcervical Intrauterine Lidocaine Instillation with Rectal Diclofenac for Pain Relief During Outpatient Hysteroscopy: A Randomized Controlled Trial

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    Sussan S. Mohammadi

    2015-05-01

    Full Text Available Objectives: There are a number of potential advantages to performing hysteroscopy in an outpatient setting. However, the ideal approach, using local uterine anesthesia or rectal non-steroidal anti-inflammatory drugs, has not been determined. Our objective was to compare the efficacy of intrauterine lidocaine instillation with rectal diclofenac for pain relief during diagnostic hysteroscopy. Methods: We conducted a double-blind randomized controlled trial on 70 nulliparous women with primary infertility undergoing diagnostic hysteroscopy. Subjects were assigned into one of two groups to receive either 100mg of rectal diclofenac or 5mL of 2% intrauterine lidocaine. The intensity of pain was measured by a numeric rating scale 0–10. Pain scoring was performed during insertion of the hysteroscope, during visualization of the intrauterine cavity, and during extrusion of the hysteroscope. Results: There were no statistically significant differences between the groups with regard to the mean pain score during intrauterine visualization (p=0.500. The mean pain score was significantly lower during insertion and extrusion of the hysteroscope in the diclofenac group (p=0.001 and p=0.030, respectively. Nine patients in the lidocaine group and five patients in diclofenac group needed supplementary intravenous propofol injection for sedation (p=0.060. Conclusions: Rectal diclofenac appears to be more effective than intrauterine lidocaine in reducing pain during insertion and extrusion of hysteroscope, but there are no significant statistical and clinical differences between the two methods with regard to the mean pain score during intrauterine inspection.

  18. Randomized clinical trial comparing lumbar percutaneous hydrodiscectomy with lumbar open microdiscectomy for the treatment of lumbar disc protrusions and herniations

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    Alexandre Fogaça Cristante

    2016-05-01

    Full Text Available OBJECTIVES: Hydrodiscectomy is a new technique used for percutaneous spinal discectomy that employs a high-intensity stream of water for herniated disc ablation and tissue aspiration. No previous clinical study has examined the effects of percutaneous hydrodiscectomy. The aim of this study is to evaluate the outcomes of hydrodiscectomy compared to open microdiscectomy regarding pain, function, satisfaction, complications and recurrence rates. METHODS: In this randomized clinical trial, patients referred to our tertiary hospital for lumbar back pain were recruited and included in the study if they had disc protrusion or small herniation in only one level, without neurological deficits and with no resolution after six weeks of conservative treatment. One group underwent open microdiscectomy, and the other group underwent percutaneous microdiscectomy via hydrosurgery. Function was evaluated using the Oswestry Disability Index and pain was assessed using a visual analog scale. Evaluations were performed preoperatively, and then during the first week and at one, three, six and twelve months postoperatively. Personal satisfaction was verified. Clinicaltrials.gov: NCT01367860. RESULTS: During the study period, 20 patients were included in each arm and 39 completed one-year of follow-up (one patient died of unrelated causes. Both groups exhibited equal improvement on the visual analog scale and Oswestry evaluations after treatment, without any significant differences. The improvement in the lumbar visual analog scale score was not significant in the hydrodiscectomy group (p=0.138. The rates of infection, pain, recurrence and satisfaction were similar between the two groups. CONCLUSION: Percutaneous hydrodiscectomy was demonstrated to be as effective as open microdiscectomy for reducing pain. The rates of complications and recurrence of herniation were similar between groups. Patient satisfaction with the treatment was also similar between groups.

  19. A meta-analysis of randomized controlled trials comparing chemotherapy plus bevacizumab with chemotherapy alone in metastatic colorectal cancer.

    Science.gov (United States)

    Cao, Yunfei; Tan, Aihua; Gao, Feng; Liu, Lidan; Liao, Cun; Mo, Zengnan

    2009-06-01

    Bevacizumab has demonstrated survival benefit in metastatic colorectal cancer (mCRC) patients when combined with chemotherapy. Several randomized clinical studies have evaluated bevacizumab in combination with chemotherapy. Meta-analysis was performed to better assess the efficacy and safety of bevacizumab with chemotherapy for mCRC. Five clinical trials randomizing a total of 3,103 mCRC patients to chemotherapy alone or to the combined treatment of chemotherapy plus bevacizumab were identified. The efficacy data included progression-free survival (PFS), overall survival (OS), and overall response rate (ORR), and the safety data contained the 60-day all-cause mortality rate, adverse events (AEs), and specific toxicity such as hypertension, thrombosis, bleeding, proteinuria, gastrointestinal perforation, diarrhea, and leucopenia. There was a significant PFS benefit (P = 0.00; hazards ratio [HR] = 0.66) and OS benefit (P = 0.00; HR = 0.77) in favor of the combined treatment. The ORR was significantly higher on the bevacizumab-containing arm (P = 0.021; relative risk [RR] = 1.5), while CR was comparable between the two arms (P = 0.09). A higher incidence of grade 3/4 AEs, grade 3/4 hypertension, grade 3/4 thromboembolic/thrombotic events, grade 3/4 bleeding, and gastrointestinal perforation was associated with the bevacizumab group. The two treatment groups were similar in terms of grade 3/4 proteinuria, grade 3/4 leukopenia, grade 3/4 diarrhea, and the 60-day all-cause mortality rate. The addition of bevacizumab to chemotherapy confers a clinically meaningful and statistically significant improvement in OS, PFS, and ORR. Its side effects are predictable and manageable and do not compound the incidence or severity of toxicities from chemotherapy.

  20. Virtual Reality Compared with Bench-Top Simulation in the Acquisition of Arthroscopic Skill: A Randomized Controlled Trial.

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    Banaszek, Daniel; You, Daniel; Chang, Justues; Pickell, Michael; Hesse, Daniel; Hopman, Wilma M; Borschneck, Daniel; Bardana, Davide

    2017-04-05

    Work-hour restrictions as set forth by the Accreditation Council for Graduate Medical Education (ACGME) and other governing bodies have forced training programs to seek out new learning tools to accelerate acquisition of both medical skills and knowledge. As a result, competency-based training has become an important part of residency training. The purpose of this study was to directly compare arthroscopic skill acquisition in both high-fidelity and low-fidelity simulator models and to assess skill transfer from either modality to a cadaveric specimen, simulating intraoperative conditions. Forty surgical novices (pre-clerkship-level medical students) voluntarily participated in this trial. Baseline demographic data, as well as data on arthroscopic knowledge and skill, were collected prior to training. Subjects were randomized to 5-week independent training sessions on a high-fidelity virtual reality arthroscopic simulator or on a bench-top arthroscopic setup, or to an untrained control group. Post-training, subjects were asked to perform a diagnostic arthroscopy on both simulators and in a simulated intraoperative environment on a cadaveric knee. A more difficult surprise task was also incorporated to evaluate skill transfer. Subjects were evaluated using the Global Rating Scale (GRS), the 14-point arthroscopic checklist, and a timer to determine procedural efficiency (time per task). Secondary outcomes focused on objective measures of virtual reality simulator motion analysis. Trainees on both simulators demonstrated a significant improvement (p virtual reality simulation group consistently outperformed the bench-top model group in the diagnostic arthroscopy crossover tests and in the simulated cadaveric setup. Furthermore, the virtual reality group demonstrated superior skill transfer in the surprise skill transfer task. Both high-fidelity and low-fidelity simulation trainings were effective in arthroscopic skill acquisition. High-fidelity virtual reality

  1. Comparing the effect of office hysteroscopy with endometrial scratch versus office hysteroscopy on intrauterine insemination outcome: a randomized controlled trial.

    Science.gov (United States)

    El-Khayat, Waleed; Elsadek, Mostafa; Saber, Waleed

    2015-11-01

    To evaluate the role of endometrial injury in the cycle preceding ovarian stimulation for intrauterine insemination (IUI) cycle on the clinical pregnancy rate. This was a prospective randomized controlled trial which included three hundred and thirty two infertile women with an indication for IUI. The subjects were randomly divided into two groups. The intervention group (group A) (n=166) subjects underwent office hysteroscopy with endometrial injury using grasping forceps with teeth, while the control group (group B) (n=166) subjects underwent office hysteroscopy alone without endometrial injury. Primary outcome was clinical pregnancy rate. There were no significant differences in baseline or clinical characteristics between the groups. There were no significant differences in clinical pregnancy rate [13.8% (23/166) versus 12% (20/166); RR 1.15 (95% CI 0.66-2.01), p=0.62]. The abortion rate [4.3% (1/23) versus 15% (3/20); RR 0.29 (95% CI 0.03-2.57), p=0.27], the multiple pregnancy rate [13% (3/23) versus 15% (3/20); RR 0.87 (95% CI 0.20-3.83), p=0.85] and the live birth rate [13.6% (22/166) versus 10.4% (17/166); RR 1.28 (95% CI 0.71-2.32), p=0.42]. There is no evidence of significant difference on the clinical pregnancy rate when endometrial scratching during hysteroscopy is compared to only hysteroscopy in women undergoing IUI. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  2. Help from home for depression: A randomised controlled trial comparing internet-delivered cognitive behaviour therapy with bibliotherapy for depression

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    Jessica Smith

    2017-09-01

    Full Text Available Major Depressive Disorder (MDD is a leading cause of the Global Burden of Disease. Cognitive Behavioural Therapy (CBT is an effective treatment for MDD, but access can be impaired due to numerous barriers. Internet-delivered CBT (iCBT can be utilised to overcome treatment barriers and is an effective treatment for depression, but has never been compared to bibliotherapy. This Randomised Controlled Trial (RCT included participants meeting diagnostic criteria for MDD (n = 270 being randomised to either: iCBT (n = 61, a CBT self-help book (bCBT (n = 77, a meditation self-help book (bMED (n = 64 or wait-list control (WLC (n = 68. The primary outcome was the Patient Health Questionnaire 9-item scale (PHQ-9 at 12-weeks (post-treatment. All three active interventions were significantly more effective than WLC in reducing depression at post-treatment, but there were no significant differences between the groups. All three interventions led to large within-group reductions in PHQ-9 scores at post-treatment (g = 0.88–1.69, which were maintained at 3-month follow-up, although there was some evidence of relapse in the bMED group (within-group g [post to follow-up] = 0.09–1.04. Self-help based interventions could be beneficial in treating depression, however vigilance needs to be applied when selecting from the range of materials available. Replication of this study with a larger sample is required.

  3. A Randomized Clinical Trial Comparing the Effectiveness of Electroacupuncture versus Medium-Frequency Electrotherapy for Discogenic Sciatica

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    Xue Zhang

    2017-01-01

    Full Text Available Objective. To investigate the short- and long-term effects of electroacupuncture (EA compared with medium-frequency electrotherapy (MFE on chronic discogenic sciatica. Methods. One hundred participants were randomized into two groups to receive EA (n=50 or MFE (n=50 for 4 weeks. A 28-week follow-up of the two groups was performed. The primary outcome measure was the average leg pain intensity. The secondary outcome measures were the low back pain intensity, Oswestry Disability Index (ODI, patient global impression (PGI, drug use frequency, and EA acceptance. Results. The mean changes in the average leg pain numerical rating scale (NRS scores were 2.30 (1.86–2.57 and 1.06 (0.62–1.51 in the EA and MFE groups at week 4, respectively. The difference was significant (P<0.001. The long-term follow-up resulted in significant differences. The average leg pain NRS scores decreased by 2.12 (1.70–2.53 and 0.36 (−0.05–0.78 from baseline in the EA and MFE groups, respectively, at week 28. However, low back pain intensity and PGI did not differ significantly at week 4. No serious adverse events occurred. Conclusions. EA showed greater short-term and long-term benefits for chronic discogenic sciatica than MFE, and the effect of EA was superior to that of MFE. The study findings warrant verification. This trial was registered under identifier ChiCTR-IPR-15006370.

  4. Can children identify and achieve goals for intervention? A randomized trial comparing two goal-setting approaches.

    Science.gov (United States)

    Vroland-Nordstrand, Kristina; Eliasson, Ann-Christin; Jacobsson, Helén; Johansson, Ulla; Krumlinde-Sundholm, Lena

    2016-06-01

    The efficacy of two different goal-setting approaches (children's self-identified goals and goals identified by parents) were compared on a goal-directed, task-oriented intervention. In this assessor-blinded parallel randomized trial, 34 children with disabilities (13 males, 21 females; mean age 9y, SD 1y 4mo) were randomized using concealed allocation to one of two 8-week, goal-directed, task-oriented intervention groups with different goal-setting approaches: (1) children's self-identified goals (n=18) using the Perceived Efficacy and Goal-Setting System, or (2) goals identified by parents (n=16) using the Canadian Occupational Performance Measure (COPM). Participants were recruited through eight paediatric rehabilitation centres and randomized between October 2011 and May 2013. The primary outcome measure was the Goal Attainment Scaling and the secondary measure, the COPM performance scale (COPM-P). Data were collected pre- and post-intervention and at the 5-month follow-up. There was no evidence of a difference in mean characteristics at baseline between groups. There was evidence of an increase in mean goal attainment (mean T score) in both groups after intervention (child-goal group: estimated mean difference [EMD] 27.84, 95% CI 22.93-32.76; parent-goal group: EMD 21.42, 95% CI 16.16-26.67). There was no evidence of a difference in the mean T scores post-intervention between the two groups (EMD 6.42, 95% CI -0.80 to 13.65). These results were sustained at the 5-month follow-up. Children's self-identified goals are achievable to the same extent as parent-identified goals and remain stable over time. Thus children can be trusted to identify their own goals for intervention, thereby influencing their involvement in their intervention programmes. © 2015 Mac Keith Press.

  5. A longitudinal trial comparing chloroquine as monotherapy or in combination with artesunate, azithromycin or atovaquone-proguanil to treat malaria.

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    Miriam K Laufer

    Full Text Available The predominance of chloroquine-susceptible falciparum malaria in Malawi more than a decade after chloroquine's withdrawal permits contemplation of re-introducing chloroquine for targeted uses. We aimed to compare the ability of different partner drugs to preserve chloroquine efficacy and prevent the re-emergence of resistance.Children with uncomplicated malaria were enrolled at a government health center in Blantyre, Malawi. Participants were randomized to receive chloroquine alone or combined with artesunate, azithromycin or atovaquone-proguanil for all episodes of uncomplicated malaria for one year. The primary outcome was incidence of clinical malaria. Secondary endpoints included treatment efficacy, and incidence of the chloroquine resistance marker pfcrt T76 and of anemia. Of the 640 children enrolled, 628 were included in the intention-to-treat analysis. Malaria incidence (95% confidence interval was 0.59 (.46-.74, .61 (.49-.76, .63 (.50-.79 and .68 (.54-.86 episodes/person-year for group randomized to receive chloroquine alone or in combination with artesunate, azithromycin or atovaquone-proguanil respectively and the differences were not statistically significant. Treatment efficacy for first episodes was 100% for chloroquine monotherapy and 97.9% for subsequent episodes of malaria. Similar results were seen in each of the chloroquine combination groups. The incidence of pfcrt T76 in pure form was 0%; mixed infections with both K76 and T76 were found in two out of 911 infections. Young children treated with chloroquine-azithromycin had higher hemoglobin concentrations at the study's end than did those in the chloroquine monotherapy group.Sustained chloroquine efficacy with repeated treatment supports the eventual re-introduction of chloroquine combinations for targeted uses such as intermittent preventive treatment.ClinicalTrials.gov NCT00379821.

  6. A Prospective Randomized Clinical Trial Comparing 3D and Standard Miniplates in Treatment of Mandibular Symphysis and Parasymphysis Fractures.

    Science.gov (United States)

    Agarwal, Mohit; Meena, Balram; Gupta, D K; Tiwari, Anjali Dave; Jakhar, Sunil Kumar

    2014-06-01

    To compare the efficacy of the 3D miniplates to standard miniplates in the osteosynthesis of mandibular symphysis and parasymphysis fractures on the basis of clinical parameters and radiographic evaluation. A prospective randomized clinical trial was conducted to treat consecutive mandibular symphysis and parasymphysis fractures. The patients were randomly divided into 2 groups. The patients underwent osteosynthesis in group A with 3D titanium miniplates and in group B with conventional titanium miniplates. The cause of trauma, the number of days from injury to surgery, average age and gender were all reviewed. The assessment of the patients was done at 1, 3, and 6 weeks and 3 months using the clinical parameters and radiographic evaluation. Eighty patients with isolated symphysis or parasymphysis fracture met the inclusion criteria. In our study, a statistically significant difference was not found in the clinical parameters such as pain, swelling, infection, paresthesia, hardware failure, and mobility between the fracture segments. Similarly Radiological evaluation did not show any statistically significant difference in reduction between the 2 groups. 3D plates are difficult to adapt and use sometimes, but operative time is less with them in treatment of symphysis and parasymphysis fractures. The use of 3D miniplates for symphysis and parasymphysis fracture fixation was efficacious enough to bear the masticatory load during osteosynthesis of the fracture. Although 3D miniplate system is difficult to adapt and difficult to use in cases of fractures involving the mental nerve, they provide the advantage of less operative time and less implant material in treatment of symphysis and parasymphysis fracture, with clinical results almost similar to those seen with conventional miniplate osteosynthesis.

  7. [Comparative investigations of a combined vaccine against parvovirus and erysipelas and corresponding monovaccines in different vaccination schedules. 1: Field trial].

    Science.gov (United States)

    Ritzmann, M; Gerbermann, H; Gyra, H; Eichinger, H M; Heinritzi, K

    1999-05-01

    In a field trial, the development of antibodies of a combined vaccine against the porcine parvovirus (PPV) as well as against swine erysipelas was compared with corresponding mono vaccines. Furthermore, these vaccines were used in different vaccination schedules. The tests were carried out on 109 gilts in three closed farms. In all gilts, a basic immunization repeated twice was carried out at the age of six months and at intervals of three weeks. The revaccination was carried out four months after the basic immunization with half of the animals, and six months after the basic immunization with the remaining gilts. Between the combined vaccine and the mono vaccine no significant differences in the development of antibodies against PPV could be found according to different vaccination schedules. The gilts having been vaccinated with the mono vaccine and boostered six months later showed significantly higher antibody titers against Erysipelothrix rhusiopathiae. Between the remaining vaccination groups no significant difference in the development of the antibodies against swine erysipelas could be found. On only one farm, a continuous decrease of antibody titers against PPV in case of altogether 238 non-vaccinated piglets until the sixth month of life could be observed. On the two other farms, an increase of antibody titers against PPV could be found at different points of time, which indicates an infection of the piglets. Between the individual vaccination groups no significant antibody titers against PPV could be measured in milk tests. With regard to the number of piglets born alive per litter, the number of piglets born dead per litter and the number of mummies, a significant difference could neither be found between the vaccination groups 1-4.

  8. A randomized clinical trial comparing hydrocolloid, phenytoin and simple dressings for the treatment of pressure ulcers [ISRCTN33429693

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    Khedmat Hossein

    2004-12-01

    Full Text Available Abstract Background Pressure sores are important and common complications of spinal cord injury. Many preventive and therapeutic approaches have been tried and new trials are evolving. One relatively recent method is application of a hydrocolloid dressing (HD. In this study we compared the therapeutic effects of HD on pressure ulcer healing with two other topical applications, phenytoin cream (PC and simple dressing (SD. Methods Ninety-one stage I and stage II pressure ulcers of 83 paraplegic male victims of the Iran-Iraq war were randomly allocated to three treatment groups. Mean age and weight of the participants were 36.64 ± 6.04 years and 61.12 ± 5.08 kg, respectively. All the patients were managed in long term care units or in their homes for 8 weeks by a team of general practitioners and nurses, and the ulcer status was recorded as "Complete healing", "Partial healing", "Without improvement" and "Worsening". Results Complete healing of ulcers, regardless of location and stage, was better in the HD group than the PC [23/31(74.19% vs 12/30(40%; difference: 34.19%, 95% CI = 10.85–57.52, (P 0.05]. We performed a second analysis considering only one ulcer per patient (i.e. 83 ulcers in 83 patients. This "per patient" analysis showed that complete ulcer healing in the HD group was better than in the PC [20/28(71.4% vs 11/28 (39.3%; difference: 32.1%, 95% CI = 7.4–56.7, (P Conclusion We deduced that HD is the most effective method investigated for treating stage I and II pressure ulcers in young paraplegic men.

  9. Randomized control trial comparing calcium hydroxide and mineral trioxide aggregate for partial pulpotomies in cariously exposed pulps of permanent molars.

    Science.gov (United States)

    Chailertvanitkul, P; Paphangkorakit, J; Sooksantisakoonchai, N; Pumas, N; Pairojamornyoot, W; Leela-Apiradee, N; Abbott, P V

    2014-09-01

    To compare the treatment outcomes when calcium hydroxide and mineral trioxide aggregate are used for partial pulpotomy in cariously exposed young permanent molars in a randomized control trial. Eighty-four teeth in 80 volunteers (aged 7-10 years) with reversible pulpitis and carious pulp exposures were randomly divided into two groups. Exposed pulps were severed using high-speed round burs until fresh pulp was seen. Cavities were irrigated with 2.5% sodium hypochlorite, and the pulp exposures were photographed and measured. Dycal or ProRoot MTA was placed on the pulp. Vitremer was placed over the material until the remaining cavity was 2 mm deep; amalgam was then placed. Teeth were evaluated for clinical symptoms and radiographic periapical changes after 24 h, 3 months, 6 months, 1 year and 2 years. Mean survival times and incidence of extraction were calculated using exact binomial confidence intervals. The median survival time for both ProRoot MTA and Dycal groups was 24 months. Three teeth had unfavourable outcomes with the incidence rate of 0.20/100 tooth-months with ProRoot MTA (95% CI: 0.02-0.71) and 0.11/100 tooth-months with Dycal (95% CI: 0.001-0.60). The incidence of unfavourable outcomes was 0.05/100 (95% CI: 0.001-0.30) and 2.38/100 (95% CI: 0.29-8.34) tooth-months in teeth with small (5 mm(2) ) pulp exposure areas, respectively. Partial pulpotomy in teeth of young patients with reversible pulpitis, either using ProRoot MTA or Dycal, resulted in favourable treatment outcomes for up to 2 years. The incidence of unfavourable outcomes tended to be higher in teeth with pulp exposure areas larger than 5 mm(2) . © 2013 International Endodontic Journal. Published by John Wiley & Sons Ltd.

  10. A randomized, pilot trial comparing full versus escalating dose regimens for the desensitization of AIDS patients allergic to sulfonamides

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    Straatmann Andrea

    2002-01-01

    Full Text Available Sulfonamides are drugs extensively used in the management of AIDS patients. However, the use of sulfonamides is often associated with the development of allergic reactions, provoking the substitution of the drug (by another that may be less effective; alternatively attempts are made to desensitize the patient. OBJECTIVE: Compare two drug regimens (full vs. escalating doses for the oral desensitization of AIDS patients allergic to sulfonamides. MATERIAL AND METHODS: AIDS patients with previous allergic reactions to sulfonamides and requiring prophylaxis against Pneumocistis carinii, central nervous system toxoplasmosis and diarrhea caused by Isospora belli were randomly assigned to a group receiving a routine dose of cothrimoxazole, or another that received escalating doses of an oral suspension of the same drug, initiating with 75mg/day of sulfamethoxazole that was doubled every 48 hours till the full dose was reached, if no allergic reaction occurred. Patients were monitored for at least 6 months after enrollment in the trial. The major end-point was the ability to maintain prophylactic treatment after that period of time. Plasma viral load (PVL and CD4/CD8 counts were measured at baseline. Liver enzymes and hematological parameters were measured at baseline and after 1, 3 and 6 months. RESULTS: Eighteen patients were enrolled in the study (15 men and 3 women, with ages ranging from 30 to 57 years (mean 39.9. The mean CD4 counts were slightly higher for patients receiving a full dose; there was also a trend towards higher baseline CD8 counts among patients developing new reactions. The mean PVL was similar among the patients in both desensitization groups. The incidence of new allergic reactions was identical (40% in the two groups. All adverse reactions were mild and no significant increase in liver enzymes were observed. CONCLUSON: Dose regimen is not a predictor of the development of new allergic reactions amongst patients challenged with

  11. A randomized, pilot trial comparing full versus escalating dose regimens for the desensitization of AIDS patients allergic to sulfonamides

    Directory of Open Access Journals (Sweden)

    Andrea Straatmann

    Full Text Available Sulfonamides are drugs extensively used in the management of AIDS patients. However, the use of sulfonamides is often associated with the development of allergic reactions, provoking the substitution of the drug (by another that may be less effective; alternatively attempts are made to desensitize the patient. OBJECTIVE: Compare two drug regimens (full vs. escalating doses for the oral desensitization of AIDS patients allergic to sulfonamides. MATERIAL AND METHODS: AIDS patients with previous allergic reactions to sulfonamides and requiring prophylaxis against Pneumocistis carinii, central nervous system toxoplasmosis and diarrhea caused by Isospora belli were randomly assigned to a group receiving a routine dose of cothrimoxazole, or another that received escalating doses of an oral suspension of the same drug, initiating with 75mg/day of sulfamethoxazole that was doubled every 48 hours till the full dose was reached, if no allergic reaction occurred. Patients were monitored for at least 6 months after enrollment in the trial. The major end-point was the ability to maintain prophylactic treatment after that period of time. Plasma viral load (PVL and CD4/CD8 counts were measured at baseline. Liver enzymes and hematological parameters were measured at baseline and after 1, 3 and 6 months. RESULTS: Eighteen patients were enrolled in the study (15 men and 3 women, with ages ranging from 30 to 57 years (mean 39.9. The mean CD4 counts were slightly higher for patients receiving a full dose; there was also a trend towards higher baseline CD8 counts among patients developing new reactions. The mean PVL was similar among the patients in both desensitization groups. The incidence of new allergic reactions was identical (40% in the two groups. All adverse reactions were mild and no significant increase in liver enzymes were observed. CONCLUSON: Dose regimen is not a predictor of the development of new allergic reactions amongst patients challenged with

  12. Intermittent Directly Observed Therapy for Abdominal Tuberculosis: A Multicenter Randomized Controlled Trial Comparing 6 Months Versus 9 Months of Therapy.

    Science.gov (United States)

    Makharia, Govind K; Ghoshal, Uday C; Ramakrishna, Balakrishnan S; Agnihotri, Abhishek; Ahuja, Vineet; Chowdhury, Sudipta Dhar; Gupta, Siddhartha Datta; Mechenro, John; Mishra, Asha; Mishra, Asha; Pathak, Manish K; Pandey, Ravinder M; Sharma, Raju; Sharma, Surendra K

    2015-09-01

    The duration of treatment of gastrointestinal tuberculosis continues to be a matter of debate. The World Health Organization advocates intermittent directly observed short-course therapy (DOTs), but there is a lack of data of its efficacy in abdominal tuberculosis. We therefore conducted a multicenter randomized controlled trial to compare 6 months and 9 months of antituberculosis therapy using DOTs. One hundred ninety-seven patients with abdominal tuberculosis (gastrointestinal, 154; peritoneal, 40; mixed, 3) were randomized to receive 6 months (n = 104) or 9 months (n = 93) of antituberculosis therapy using intermittent directly observed therapy. Patients were followed up 1 year after completion of treatment to assess recurrence. Patients were evaluated for primary endpoint (complete clinical response, partial response, and no response) and secondary endpoint (recurrence of the disease at the end of 1 year of follow-up). Baseline characteristics were similar between the 2 randomized groups. There was no difference between the 6-month group and 9-month group in the complete clinical response rate on per-protocol analysis (91.5% vs 90.8%; P = .88) or intent-to-treat analysis (75% vs 75.8%; P = .89). Only 1 patient in the 9-month group and no patients in the 6-month group had recurrence of disease. Side effects occurred in 21 (21.3%) and 16 (18.2%) patients in the 6-month and 9-month groups, respectively. There was no difference in efficacy of antituberculosis therapy delivered for either 6 months or 9 months in either gastrointestinal or peritoneal tuberculosis, confirming the efficacy of intermittent directly observed therapy. NCT01124929. © The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  13. Voice Quality After Treatment of Early Vocal Cord Cancer: A Randomized Trial Comparing Laser Surgery With Radiation Therapy

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    Aaltonen, Leena-Maija, E-mail: leena-maija.aaltonen@hus.fi [Department of Otorhinolaryngology–Head and Neck Surgery, Helsinki University Central Hospital, and University of Helsinki, Helsinki (Finland); Rautiainen, Noora; Sellman, Jaana [Institute of Behavioural Sciences, University of Helsinki, Helsinki (Finland); Saarilahti, Kauko [Department of Oncology, Helsinki University Central Hospital, and University of Helsinki, Helsinki (Finland); Mäkitie, Antti; Rihkanen, Heikki [Department of Otorhinolaryngology–Head and Neck Surgery, Helsinki University Central Hospital, and University of Helsinki, Helsinki (Finland); Laranne, Jussi; Kleemola, Leenamaija [Department of Otorhinolaryngology–Head and Neck Surgery, Tampere University Hospital, and University of Tampere, Tampere (Finland); Wigren, Tuija [Department of Oncology, Tampere University Hospital, and University of Tampere, Tampere (Finland); Sala, Eeva [Department of Otorhinolaryngology–Head and Neck Surgery, Turku University Hospital, and University of Turku, Turku (Finland); Lindholm, Paula [Department of Oncology, Turku University Hospital, and University of Turku, Turku (Finland); Grenman, Reidar [Department of Otorhinolaryngology–Head and Neck Surgery, Turku University Hospital, and University of Turku, Turku (Finland); Joensuu, Heikki [Department of Oncology, Helsinki University Central Hospital, and University of Helsinki, Helsinki (Finland)

    2014-10-01

    Objective: Early laryngeal cancer is usually treated with either transoral laser surgery or radiation therapy. The quality of voice achieved with these treatments has not been compared in a randomized trial. Methods and Materials: Male patients with carcinoma limited to 1 mobile vocal cord (T1aN0M0) were randomly assigned to receive either laser surgery (n=32) or external beam radiation therapy (n=28). Surgery consisted of tumor excision with a CO{sub 2} laser with the patient under general anaesthesia. External beam radiation therapy to the larynx was delivered to a cumulative dose of 66 Gy in 2-Gy daily fractions over 6.5 weeks. Voice quality was assessed at baseline and 6 and 24 months after treatment. The main outcome measures were expert-rated voice quality on a grade, roughness, breathiness, asthenia, and strain (GRBAS) scale, videolaryngostroboscopic findings, and the patients' self-rated voice quality and its impact on activities of daily living. Results: Overall voice quality between the groups was rated similar, but voice was more breathy and the glottal gap was wider in patients treated with laser surgery than in those who received radiation therapy. Patients treated with radiation therapy reported less hoarseness-related inconvenience in daily living 2 years after treatment. Three patients in each group had local cancer recurrence within 2 years from randomization. Conclusions: Radiation therapy may be the treatment of choice for patients whose requirements for voice quality are demanding. Overall voice quality was similar in both treatment groups, however, indicating a need for careful consideration of patient-related factors in the choice of a treatment option.

  14. A randomised trial comparing the laryngeal mask airway Supreme™ with the laryngeal mask airway Unique™ in children.

    Science.gov (United States)

    Jagannathan, N; Sohn, L E; Sawardekar, A; Chang, E; Langen, K E; Anderson, K

    2012-02-01

    We conducted a randomised controlled trial comparing the laryngeal mask airway Supreme(™) with the laryngeal mask airway Unique(™) in children. Fifty children presenting for elective surgery were randomly assigned to receive either the laryngeal mask airway Supreme or laryngeal mask airway Unique. The outcomes measured were airway leak pressure, ease and time for insertion, insertion success rate, fibreoptic examination, incidence of gastric insufflation, ease of gastric tube placement through the laryngeal mask airway Supreme, quality of airway during anaesthetic maintenance and complications. Median (IQR [range]) time to successful device placement was shorter with the laryngeal mask airway Unique, 14.5 [13.5-16.3 (10.0-23.6)] s than with the laryngeal mask airway Supreme, 17.4 [14.8-19.8 (11.5-29.2)] s; p = 0.007. Median (IQR [range]) airway leak pressures for the laryngeal mask airway Supreme and laryngeal mask airway Unique were 20 [16-21 (12-22)] cmH(2)O and 15 [14-18 (10-24)] cmH(2)O, respectively (p = 0.001). The incidence of gastric insufflation was lower with the laryngeal mask airway Supreme (zero vs six patients), p = 0.01. In conclusion, the laryngeal mask airway Supreme performed as well as the laryngeal mask airway Unique and is a useful alternative for airway maintenance, particularly in children who require evacuation of gastric contents during anaesthesia. Anaesthesia © 2011 The Association of Anaesthetists of Great Britain and Ireland.

  15. The Effect of Oxygen Inhalation Plus Oxytocin Compared with Oxytocin Only on Postpartum Haemorrhage: A Randomized Clinical Trial.

    Science.gov (United States)

    Suhrabi, Zainab; Taghinejad, Hamid; Direkvand-Moghadam, Ashraf; Akbari, Malihe

    2016-09-01

    Post Partum Haemorrhage (PPH) is the leading cause of maternal mortality across the world, mainly in the developing countries. The present study was conducted with the aim to investigate effect of oxygen inhalation plus oxytocin compared with oxytocin only on PPH. This study was a clinical trial which was performed in Shahid Mustafa Khomieni Teaching Hospital of Ilam (western Iran) from April 2012 to Nov 2013. One hundred and twenty pregnant women who were referred to delivery ward for normal vaginal delivery were selected with convenience sampling method and they were randomly assigned into two groups. For both groups management of the third stage of labour was done using 1000CC Ringer and 20 units of Oxytocin. In the intervention group, in addition to the routine administration, 8 liters of oxygen via face mask was used continuously until 2 hours after delivery. Blood loss was determined by regular weighing of the buttocks that were previously weighted. The difference was calculated before and after weighing (1 gram increasing of weight was considered to be equivalent to 1CC blood loss). Data were analysed by SPSS 16 version using Student- t and Chi-square tests. The two groups were homogenous in regard to all the base line variables. The study results indicated that the mean of blood loss were (256.16±97) ml at two hours after delivery in the control group and (149.5±46.49) ml in the intervention group. There was a significant difference between PPH of the two groups (poxytocin infusion during 2hours later resulted in a significant decreasing in the amount of bleeding after normal vaginal delivery.

  16. Improvement of 10-km time-trial cycling with motivational self-talk compared with neutral self-talk.

    Science.gov (United States)

    Barwood, Martin J; Corbett, Jo; Wagstaff, Christopher R D; McVeigh, Dan; Thelwell, Richard C

    2015-03-01

    Unpleasant physical sensations during maximal exercise may manifest themselves as negative cognitions that impair performance, alter pacing, and are linked to increased rating of perceived exertion (RPE). This study examined whether motivational self-talk (M-ST) could reduce RPE and change pacing strategy, thereby enhancing 10-km time-trial (TT) cycling performance in contrast to neutral self-talk (N-ST). Fourteen men undertook 4 TTs, TT1-TT4. After TT2, participants were matched into groups based on TT2 completion time and underwent M-ST (n=7) or N-ST (n=7) after TT3. Performance, power output, RPE, and oxygen uptake (VO2) were compared across 1-km segments using ANOVA. Confidence intervals (95%CI) were calculated for performance data. After TT3 (ie, before intervention), completion times were not different between groups (M-ST, 1120±113 s; N-ST, 1150±110 s). After M-ST, TT4 completion time was faster (1078±96 s); the N-ST remained similar (1165±111 s). The M-ST group achieved this through a higher power output and VO2 in TT4 (6th-10th km). RPE was unchanged. CI data indicated the likely true performance effect lay between 13- and 71-s improvement (TT4 vs TT3). M-ST improved endurance performance and enabled a higher power output, whereas N-ST induced no change. The VO2 response matched the increase in power output, yet RPE was unchanged, thereby inferring a perceptual benefit through M-ST. The valence and content of self-talk are important determinants of the efficacy of this intervention. These findings are primarily discussed in the context of the psychobiological model of pacing.

  17. COMPARATIVE STUDY OF 4 WEEKS OF DYNAMIC B ALANCE TRAINING PROGRAM IN COLLEGIATE FOOTBALL PLAYERS: RANDOMIZED CLINICAL TRIAL

    Directory of Open Access Journals (Sweden)

    Nisha

    2015-03-01

    Full Text Available BACKGROUND: Balance is highly integrative dynamic process involving coordination of multiple neurological pathways that allows for the maintenance of the COG over BOS . Football players often perform lower extremity passing , shooting , twisting , cutting and dribbling skills while wearing shoes , these actions require body to be in the equilibrium position to perform the task . This leads to t he conclusion of the great importance of the ability of balance in football . AIMS: 1 . To study the effect of 4 week multidirectional balance board training on dynamic balance in football players . 2 . To study the effect of 4 week Both Sides Up ball training on dynamic balance in football players . 3 . To compare the effect of multidirectional balance board training program and BOSU ball training program on dynamic balance in football players . STUDY DESIGN: Randomized Clinical trial . METHODS: Total of 60 competitive badminton players with age group between18 - 25 were recruited in this study . The participants were allocated into 2 groups viz ., Group A (multidirectional balance board training and Group B (BOSU ball Training for a period of 4 we eks . Participants were test for SEBT and vertical jump test on first day and after 4 weeks of balance training . STATISTICAL ANALYSIS: Student t test ,