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Sample records for term breech trial

  1. Vaginal breech birth: can we move beyond the Term Breech Trial?

    Science.gov (United States)

    Hunter, Linda A

    2014-01-01

    Since the publication of the Term Breech Trial in 2000, planned cesarean has become the preferred mode of birth for women whose fetus is in a breech presentation. Over the past 20 years, however, subsequent evidence has not shown conclusively that cesarean birth is safer than vaginal birth for a fetus in a breech presentation when certain criteria are met. Many obstetric organizations support the option of planned vaginal birth for women with a breech presentation under strict prelabor selection criteria and intrapartum management guidelines. The growing trend toward cesarean unfortunately has left midwives and other intrapartum care providers in training with dwindling opportunities to competently master skills for vaginal breech birth. Although simulation training offers opportunities to practice infrequently encountered skills such as vaginal breech birth, it is unknown if this alternative will provide sufficient experience for future generations of clinicians. As a result, women with a breech presentation at term who desire a trial of labor often have limited choices. This article reviews the controversies surrounding the ideal mode of birth created by the Term Breech Trial. Criteria for vaginal breech birth are summarized and the role of simulation explored. Implications for midwifery practice when a breech presentation is diagnosed are also included. © 2014 by the American College of Nurse-Midwives.

  2. Consequences of the term breech trial in Denmark

    DEFF Research Database (Denmark)

    Hartnack Tharin, J.E.; Krebs, L.; Rasmussen, S.

    2011-01-01

    Objective. To analyze the consequences of the handling of breech presentation in Denmark after publication of the Term Breech Trial (TBT). Design. Population-based retrospective cohort study. Settings. Data from the National Birth Registry and discharge letters from cases with perinatal death....... Population. Singleton breech fetuses at termand alive at onset of labor delivered between 1997 and 2008 (n=23 789). Methods. Outcomes before and after publication of TBT were compared and analyzed by planned mode of delivery. Main outcome measures. Cesarean section, intrapartum or early neonatal mortality...

  3. Term breech delivery in The Netherlands

    NARCIS (Netherlands)

    Rietberg, C.C.

    2006-01-01

    The management of the term breech delivery has been a subject of discussion for many years. Only a few randomized trials had been performed on outcome in relation to the mode of delivery in case of breech position. In october 2000 the results of the Term Breech Trial (TBT) were published, in which

  4. Tocolysis in term breech external cephalic version.

    Science.gov (United States)

    Nor Azlin, M I; Haliza, H; Mahdy, Z A; Anson, I; Fahya, M N; Jamil, M A

    2005-01-01

    To study the effect of ritodrine tocolysis on the success of external cephalic version (ECV) and to assess the role of ECV in breech presentation at our centre. A prospective randomized double-blind-controlled trial comparing ritodrine and placebo in ECV of singleton term breech pregnancy at a tertiary hospital. Among the 60 patients who were recruited, there was a success rate of 36.7%. Ritodrine tocolysis significantly improved the success rate of ECV (50% vs. 23%; P=0.032). There was a marked effect of ritodrine tocolysis on the ECV success in nulliparae (36.4% vs. 13.0%) and multiparae (87.5% vs. 57.1%). External cephalic version has shown to reduce the rate of cesarean section for breech presentation by 33.5% in our unit. External cephalic version significantly reduced the rate of cesarean section in breech presentation, and ritodrine tocolysis improved the success of ECV and should be offered to both nulliparous and parous women in the case of term breech presentation.

  5. Evaluation of a decision aid for women with breech presentation at term: a randomised controlled trial [ISRCTN14570598

    Science.gov (United States)

    Nassar, N; Roberts, CL; Raynes-Greenow, CH; Barratt, A; Peat, B

    2007-01-01

    Objectives To evaluate the effectiveness of a decision aid for women with a breech presentation compared with usual care. Design Randomised controlled trial. Setting Tertiary obstetric hospitals offering external cephalic version (ECV). Population Women with a singleton pregnancy were diagnosed antenatally with a breech presentation at term, and were clinically eligible for ECV. Methods Women were randomised to either receive a decision aid about the management options for breech presentation in addition to usual care or to receive usual care only with standard counselling from their usual pregnancy care provider. The decision aid comprised a 24-page booklet supplemented by a 30-minute audio-CD and worksheet that was designed for women to take home and review with a partner. Main outcome measures Decisional conflict (uncertainty), knowledge, anxiety and satisfaction with decision making, and were assessed using self-administered questionnaires. Results Compared with usual care, women reviewing the decision aid experienced significantly lower decisional conflict (mean difference −8.92; 95% CI −13.18, −4.66) and increased knowledge (mean difference 8.40; 95% CI 3.10, 13.71), were more likely to feel that they had enough information to make a decision (RR 1.30; 95% CI 1.14, 1.47), had no increase in anxiety and reported greater satisfaction with decision making and overall experience of pregnancy and childbirth. In contrast, 19% of women in the usual care group reported they would have made a different decision about their care. Conclusions A decision aid is an effective and acceptable tool for pregnant women that provides an important adjunct to standard counselling for the management of breech presentation. Please cite this paper as: Nassar N, Roberts C, Raynes-Greenow C, Barratt A, Peat B, on behalf of the Decision Aid for Breech Presentation Trial Collaborators. Evaluation of a decision aid for women with breech presentation at term: a randomised controlled

  6. External cephalic version for breech presentation with or without spinal analgesia in nulliparous women at term: a randomized controlled trial.

    Science.gov (United States)

    Weiniger, Carolyn F; Ginosar, Yehuda; Elchalal, Uriel; Sharon, Einav; Nokrian, Malka; Ezra, Yossef

    2007-12-01

    To compare the success of external cephalic version using spinal analgesia with no analgesia among nulliparas. A prospective randomized controlled trial was performed in a tertiary referral center delivery suite. Nulliparous women at term requesting external cephalic version for breech presentation were randomized to receive spinal analgesia (7.5 mg bupivacaine) or no analgesia before the external cephalic version. An experienced obstetrician performed the external cephalic version. Primary outcome was successful conversion to vertex presentation. Seventy-four women were enrolled, and 70 analyzed (36 spinal, 34 no analgesia). Successful external cephalic version occurred among 24 of 36 (66.7%) women randomized to receive spinal analgesia compared with 11 of 34 (32.4%) without, P=.004 (95% confidence interval [CI] of the difference: 0.0954-0.5513). External cephalic version with spinal analgesia resulted in a lower visual analog pain score, 1.76+/-2.74 compared with 6.84+/-3.08 without, Pexternal cephalic version success was 4.0-fold higher when performed with spinal analgesia P=.02 (95% CI, odds ratio [OR] 1.2-12.9). Complete breech presentation before attempting external cephalic version increased the odds of success 8.2-fold, P=.001 (95% CI, OR 2.2-30.3). Placental position, estimated fetal weight, and maternal weight did not contribute to the success rate when spinal analgesia was used. There were no cases of placental abruption or fetal distress. Administration of spinal analgesia significantly increases the success rate of external cephalic version among nulliparous women at term, which allows possible normal vaginal delivery. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00119184 I.

  7. Tocolysis for repeat external cephalic version in breech presentation at term: a randomised, double-blinded, placebo-controlled trial.

    Science.gov (United States)

    Impey, Lawrence; Pandit, Meghana

    2005-05-01

    External cephalic version (ECV) reduces the incidence of breech presentation at term and caesarean section for non-cephalic births. Tocolytics may improve success rates, but are time consuming, may cause side effects and have not been proven to alter caesarean section rates. The aim of this trial was to determine whether tocolysis should be used if ECV is being re-attempted after a failed attempt. To determine whether tocolysis should be used if ECV is being re-attempted after a failed attempt. Randomised, double-blinded, placebo-controlled trial. UK teaching hospital. One hundred and twenty-four women with a breech presentation at term who had undergone an unsuccessful attempt at ECV. Relative risks with 95% confidence intervals for categorical variables and a t test for continuous variables. Analysis was by intention to treat. Incidence of cephalic presentation at delivery. Secondary outcomes were caesarean section and measures of neonatal and maternal morbidity. The use of tocolysis for a repeat attempt at ECV significantly increases the incidence of cephalic presentation at delivery (RR 3.21; 95% CI 1.23-8.39) and reduces the incidence of caesarean section (RR 0.33; 95% CI 0.14-0.80). The effects were most marked in multiparous women (RR for cephalic presentation at delivery 9.38; 95% CI 1.64-53.62). Maternal and neonatal morbidity remain unchanged. The use of tocolysis increases the success rate of repeat ECV and reduces the incidence of caesarean section. A policy of only using tocolysis where an initial attempt has failed leads to a relatively high success rate with minimum usage of tocolysis.

  8. Maternal and neonatal complications in term breech delivered vaginally

    International Nuclear Information System (INIS)

    Jadoon, S.; Jadoon, S.M.K.; Shah, R.

    2008-01-01

    To evaluate the maternal and neonatal complications in terms of genital tract trauma to mother, perinatal mortality. Apgar score at 5 minutes and neonatal trauma in all singleton term breech cases delivered vaginally. A 100 consecutive patients with singleton breech presentation, whether booked or unbooked, were admitted and delivered vaginally in hospital during the study period. They were studied for maternal and neonatal complications. Maternal complication included any genital tract trauma during delivery while neonatal complications were perinatal mortality, low Apgar score (less than eight at 5 minutes) and birth trauma. There were a total 3977 deliveries during this study period, 145 breech presentation (incidence 3.6%). Out of those, 100 were included in the study. All were unbooked cases, 87% were multigravida while 13% were primigravida. An Apgar score of eight was recorded in 87% babies while 10% had an Apgar score of less than eight after 5 minutes. There were 3 still births and one neonatal death. Aggregated perinatal mortality rate was 40/1000 live births. Only one baby had birth trauma (Erbs paralysis) during vaginal breech delivery. Ninety seven (97%) mothers had no complications while only 3 (3%) had complications. Out of these, one had cervical tear and 2 had vaginal tears. Offering a trial of vaginal breech delivery to strictly selected and well-counselled patients remains an appropriate option without compromising perinatal and maternal outcome. It also decreases the rate of operative delivery for this malpresentation. (author)

  9. Breech at term--mode of delivery?

    DEFF Research Database (Denmark)

    Krebs, L; Langhoff-Roos, J; Weber, T

    1995-01-01

    BACKGROUND: The present study was designed to determine neonatal mortality and morbidity in non-malformed singleton term infants delivered in breech presentation and identify a possible correlation between outcome on the one hand and mode of delivery, parity and birth weight on the other. METHODS...

  10. [External cephalic version of breech presentation at term].

    Science.gov (United States)

    Albrechtsen, Susanne; Berge, Lillian N; Børdahl, Per E; Egeland, Thore; Henriksen, Tore; Håheim, Lise Lund; Øian, Pål

    2005-03-03

    External cephalic version could be an alternative to either vaginal delivery or caesarean section in breech presentation at term. A systematic literature review about external cephalic version in breech presentation. The numbers of breech presentation delivered by caesarean section could probably be reduced in Norway by offering version, but this would not affect perinatal mortality.

  11. Remifentanil analgesia during external cephalic version for breech presentation in nulliparous women at term: A randomized controlled trial.

    Science.gov (United States)

    Wang, Zhi-Hong; Yang, Yi; Xu, Gui-Ping

    2017-03-01

    The aim of the study was to assess the efficacy and safety of remifentanil for pain relief during external cephalic version (ECV) for breech presentation in nulliparous women at term. A total of 144 nulliparous women with singleton breech presentation were randomly divided into the intervention group and the placebo group, with 72 subjects in each group. The subjects in the intervention group received remifentanil (infused at 0.1 μg kg min with demand boluses of 0.1 μg/kg), whereas those in the placebo group were given saline placebo. This study was conducted from May 2013 to April 2016. The outcomes measures include pain (measured with the visual analog scale, VAS), success rate of ECV, maternal satisfaction for ECV, and adverse events. A total of 137 participants completed the study. The intervention with remifentanil showed greater efficacy than did placebo in decreasing the VAS score immediately after ECV (intervention group 4.3 ± 2.2 vs placebo group 6.4 ± 2.5, P < 0.01). A significant difference in the ECV success rate was also found between the 2 groups (intervention group 56.9% vs placebo group 38.9%, P = 0.03). In addition, a significant difference in the satisfaction score was also detected (intervention group 9.3 ± 0.9 vs placebo group 6.7 ± 1.2, P < 0.01). The observed adverse events were similar between the 2 groups. This study shows that remifentanil could decrease pain, improve the ECV success rate, and improve satisfaction in nulliparous women at term during the period of ECV. Furthermore, it is also well tolerated with few adverse events.

  12. Pregnancy outcome in singleton term breeches from a referral ...

    African Journals Online (AJOL)

    It is recommended that attention should be given to trainee obstetrician in selective external cephalic version at term and also the procedure of AVBD so as to reduce the caesarean section rate and also neonatal morbidity in term breeches in our community. Keywords: Pregnancy outcome, Singleton breech, Vaginal ...

  13. Elective cesarean delivery for term breech

    DEFF Research Database (Denmark)

    Krebs, Lone; Langhoff-Roos, Jens

    2003-01-01

    and anemia (RR 0.91; 95% CI 0.84, 0.97), and operations for wound infection (RR 0.69; 95% CI 0.57, 0.83) than emergency cesarean delivery. There was a higher rate of puerperal fever and pelvic infection (RR 1.20; 95% CI 1.11, 1.25) than for vaginal delivery. Thromboembolic disease occurred in 0.1% of women......OBJECTIVE: To compare the maternal complications of elective cesarean delivery for breech at term with those after vaginal or emergency cesarean delivery. METHODS: We conducted a population-based, retrospective cohort study of 15441 primiparas who delivered singleton breech at term. Information...... was obtained from the Danish Medical Birth Register, the Register of Death Causes, and the Denmark Patient Register. RESULTS: Elective cesarean delivery was associated with lower rates of puerperal fever and pelvic infection (relative risk [RR] 0.81; 95% confidence interval [CI] 0.70, 0.92), hemorrhage...

  14. External cephalic version for breech presentation at term.

    Science.gov (United States)

    Hofmeyr, G Justus; Kulier, Regina; West, Helen M

    2015-04-01

    Management of breech presentation is controversial, particularly in regard to manipulation of the position of the fetus by external cephalic version (ECV). ECV may reduce the number of breech presentations and caesarean sections, but there also have been reports of complications with the procedure. The objective of this review was to assess the effects of ECV at or near term on measures of pregnancy outcome. Methods of facilitating ECV, and ECV before term are reviewed separately. We searched the Cochrane Pregnancy and Childbirth Trials Register (28 February 2015) and reference lists of retrieved studies. Randomised trials of ECV at or near term (with or without tocolysis) compared with no attempt at ECV in women with breech presentation. Two review authors assessed eligibility and trial quality, and extracted the data. We included eight studies, with a total of 1308 women randomised. The pooled data from these studies show a statistically significant and clinically meaningful reduction in non-cephalic presentation at birth (average risk ratio (RR) 0.42, 95% confidence interval (CI) 0.29 to 0.61, eight trials, 1305 women); vaginal cephalic birth not achieved (average RR 0.46, 95% CI 0.33 to 0.62, seven trials, 1253 women, evidence graded very low); and caesarean section (average RR 0.57, 95% CI 0.40 to 0.82, eight trials, 1305 women, evidence graded very low) when ECV was attempted in comparison to no ECV attempted. There were no significant differences in the incidence of Apgar score ratings below seven at one minute (average RR 0.67, 95% CI 0.32 to 1.37, three trials, 168 infants) or five minutes (RR 0.63, 95% CI 0.29 to 1.36, five trials, 428 infants, evidence graded very low), low umbilical vein pH levels (RR 0.65, 95% CI 0.17 to 2.44, one trial, 52 infants, evidence graded very low), neonatal admission (RR 0.80, 95% CI 0.48 to 1.34, four trials, 368 infants, evidence graded very low), perinatal death (RR 0.39, 95% CI 0.09 to 1.64, eight trials, 1305 infants

  15. External cephalic version for breech presentation before term.

    Science.gov (United States)

    Hutton, Eileen K; Hofmeyr, G Justus; Dowswell, Therese

    2015-07-29

    External cephalic version (ECV) of the breech fetus at term (after 37 weeks) has been shown to be effective in reducing the number of breech presentations and caesarean sections, but the rates of success are relatively low. This review examines studies initiating ECV prior to term (before 37 weeks' gestation). To assess the effectiveness of a policy of beginning ECV before term (before 37 weeks' gestation) for breech presentation on fetal presentation at birth, method of delivery, and the rate of preterm birth, perinatal morbidity, stillbirth or neonatal mortality. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 March 2015) and reference lists of retrieved studies. Randomised controlled trials (RCTs) of ECV attempted before term (37 weeks' gestation) or commenced before term, compared with a control group of women (in breech presentation) in which either no ECV attempted or ECV was attempted at term. Cluster-randomised trials were eligible for inclusion but none were identified. Quasi-RCTs or studies using a cross-over design were not eligible for inclusion. Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked for accuracy. Studies were assessed for risk of bias and for important outcomes the overall quality of the evidence was assessed using the GRADE approach. Five studies are included (2187 women). It was not possible for the intervention to be blinded, and it is not clear what impact lack of blinding would have on the outcomes reported. For other 'Risk of bias' domains studies were either at low or unclear risk of bias.One study reported on ECV that was undertaken and completed before 37 weeks' gestation compared with no ECV. No difference was found in the rate of non-cephalic presentation at birth (risk ratio (RR) 1.04, 95% confidence interval (CI) 0.64 to 1.69; participants = 102). One study reported on a policy of ECV that was initiated before term (33 weeks) and up until 40

  16. External cephalic version for breech presentation at term

    International Nuclear Information System (INIS)

    Rauf, B.; Hassan, L.

    2007-01-01

    To assess the success rate of External Cephalic Version (ECV) at term and its effects on measures of pregnancy outcome. A total of 40 patients were offered ECV over a period of fourteen months. All singleton breech presentations with an otherwise normal antenatal course between 36-41 weeks of gestation were included in the study. Exclusion criteria included contraindications to ECV i.e. multiple pregnancy, oligohydramnios, growth retardation, antepartum hemorrhage, rupture of membranes toxemias of pregnancy, non-reassuring fetal monitoring pattern, previous uterine scar, bad obstetric history, any contraindication to vaginal delivery, labour and patient wishes after thorough counseling. Overall success rate of the procedure and its effect on maternal and fetal outcome was determined. Significance of results was determined using Chi-square test. A total of 40 patients were recruited for the trial. Overall success rate was 67.5% with only 30% being primi-gravida (p<0.05). Multi-gravida showed higher success rate of 80%. Following successful ECV, spontaneous vaginal delivery was attained in 77.7% (n=21), while caesarean section was performed due to various indications in about 6 cases (p<0.05). Following failed version, 61.5% (n=8) had elective C/S and only 5 delivered vaginally. Route of delivery did not affect the perinatal outcome except for congenital abnormalities. Following successful ECV, there was only one stillbirth. Overall live births associated with successful version was 96.2% (p<0.05), while in failed version, there were no fetal deaths. ECV at term appears to be a useful procedure to reduce the number and associated complications of term breech presentation. It is safe for the mother and the fetus and helps to avoid a significant number of caesarean sections. (author)

  17. Term pregnancy in breech presentation in a unicornuate uterus: a ...

    African Journals Online (AJOL)

    This is a case report of an eighteen-year-old woman who presented at 38 weeks gestation in labour with the fetus in breech presentation. A caesarean section was performed, intraoperatively she was found to have a unicornuate uterus with a rudimentary horn. Term pregnancies are possible in patients with mullerian ...

  18. The relation of breech presentation at term to epilepsy in childhood

    DEFF Research Database (Denmark)

    Krebs, Lone; Langhoff-Roos, Jens

    2006-01-01

    with epilepsy until year 1996. For each case delivered in breech presentation (n = 290), the two subsequent deliveries of non-malformed, singleton infants delivered in breech presentation at term at the same hospital were selected as controls (n = 580). RESULTS: Breech presentation was a risk factor...

  19. Risks of vaginal breech delivery at term compared with elective cesarean section - reply to comments by Walker and Powell, and Sholapurkar

    NARCIS (Netherlands)

    Vlemmix, Floortje; Mol, Ben Willem; Kok, Marjolein

    2015-01-01

    We thank both Walker and Powell (1), as well as Sholapurkar (2) for their interest in our work. Walker and Powell note that the risk of neonatal mortality for planned vaginal breech delivery (VBD) in our study is lower than the mortality reported in the term breech trial and comparable to the risk

  20. Contribution of changing risk factors to the trend in breech presentation at term.

    Science.gov (United States)

    Bin, Yu Sun; Roberts, Christine L; Nicholl, Michael C; Nassar, Natasha; Ford, Jane B

    2016-12-01

    Recent population-wide changes in perinatal risk factors may affect rates of breech presentation at birth, and have implications for the provision of breech services and training in breech management. To investigate whether changes in maternal and pregnancy characteristics explain the observed trend in breech presentation at term. All singleton term (≥37 week) births in New South Wales during 2002-2012 were identified through birth and associated hospital records. Annual rates of breech presentation were determined. Logistic regression modelling was used to predict expected rates of breech presentation and these were compared with observed rates over time. A priori predictors included maternal age, country of birth, parity, smoking during pregnancy, diabetes, pregnancy hypertension, placenta praevia, previous singleton term breech, previous caesarean section, infant sex, gestational age, birthweight and congenital anomalies. Hospital and Medicare data were used to assess concomitant trends in external cephalic version. Among 914 147 singleton term births, 3.1% were breech at delivery. Rates of breech presentation declined from 3.6% in 2002 to 2.7% in 2012 (test for trend P breech presentation and previous caesarean section. However, use of external cephalic version appears to have increased over time. Breech presentation at delivery has decreased in New South Wales. Increased use of external cephalic version likely accounts for this decline, as changes in risk factors do not. © 2016 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

  1. Moxibustion for breech version: a randomized controlled trial.

    Science.gov (United States)

    Guittier, Marie-Julia; Pichon, Michelle; Dong, Hongguang; Irion, Olivier; Boulvain, Michel

    2009-11-01

    To estimate the efficacy of moxibustion between 34 and 38 weeks of gestation to facilitate the cephalic version of fetuses in breech presentation and the acceptability of this method by women. We conducted a randomized controlled trial in a Swiss university hospital maternity unit. We proposed to stimulate the acupoint BL 67 by moxibustion daily for 2 weeks for 212 consenting women between 34 and 36 weeks of gestation with a single fetus in breech presentation. We did the intervention three times weekly in the hospital and a teaching session and information leaflet on the technique for additional daily therapy at home. The control group received expectant management care. The availability of external cephalic version was maintained for both groups. The main outcome measure was the comparison of the proportion of women with cephalic presentation at delivery. Baseline characteristics were similar between groups, except more nulliparous women were randomized to moxibustion. The percentage of versions was similar between groups: 18% in the moxibustion group compared with 16% in the control group (relative risk 1.12, 95% confidence interval 0.62 to 2.03). Adjustment for the imbalance in parity did not change these results. The frequency of cesarean delivery was similar (64% compared with 58% in the moxibustion group and the control group, respectively). Acceptability of the intervention and women's perceptions of moxibustion were favorable. We observed no beneficial effect of moxibustion to facilitate the cephalic version of fetuses in breech presentation. Despite this lack of proven effectiveness, women had positive opinions on the intervention. ClinicalTrials.gov, www.clinicaltrials.gov,NCT00890474. I.

  2. Changes in vaginal breech delivery rates in a single large metropolitan area.

    LENUS (Irish Health Repository)

    Hehir, Mark P

    2012-06-01

    Vaginal breech delivery rates have been accepted widely to be in decline and the Term Breech Trial (TBT) has recommended delivery of a breech-presenting infant by elective cesarean section delivery. Our aim was to examine the rate of vaginal delivery of term breech pregnancies in the 8 years before and after the publication of the TBT.

  3. Management of breech presentation at term: a retrospective cohort study of 10 years of experience.

    Science.gov (United States)

    Burgos, J; Rodríguez, L; Cobos, P; Osuna, C; Del Mar Centeno, M; Larrieta, R; Martínez-Astorquiza, T; Fernández-Llebrez, L

    2015-10-01

    To evaluate the impact of management of childbirth (external cephalic version (ECV) plus planned vaginal delivery (PVD)) of breech presentation at term (⩾37 weeks of gestation). This retrospective cohort study was based on data collected of singleton breech presentations at term in the Obstetrics and Gynaecology Service, Cruces University Hospital (Biscay, Spain), from January 2003 to December 2012. We attended 2377 singleton breech pregnancies at term. We attended 1684 singleton breech term deliveries, attempting vaginal delivery after selection in 52.9% of cases and were successful in 57.5% of attempts. A total of 1360 ECV were attempted, with a success rate of 50.3% of those attempted. The use of ECV has decreased the rate of breech presentation at delivery by 39.0%, the rate of breech presentation as a caesarean section (CS) indication by 47.1% (CS due to breech presentation/total of CS) and the rate of CS for breech presentation out of the total of deliveries by 39.1% (CS due to breech presentation/total of deliveries). Early postnatal parameters (5-min Apgar score, umbilical cord arterial pH and acid-base analysis) were significantly lower following PVD compared with planned CS for breech presentation. However, we did not find any differences in the rates of admissions to the neonatal unit or neonatal mortality. Management of breech presentation with a protocol that includes ECV, careful selection criteria and active management of vaginal delivery achieve a great decrease in the rate of CS for breech presentation.

  4. Cost-effectiveness of external cephalic version for term breech presentation.

    Science.gov (United States)

    Tan, Jonathan M; Macario, Alex; Carvalho, Brendan; Druzin, Maurice L; El-Sayed, Yasser Y

    2010-01-21

    External cephalic version (ECV) is recommended by the American College of Obstetricians and Gynecologists to convert a breech fetus to vertex position and reduce the need for cesarean delivery. The goal of this study was to determine the incremental cost-effectiveness ratio, from society's perspective, of ECV compared to scheduled cesarean for term breech presentation. A computer-based decision model (TreeAge Pro 2008, Tree Age Software, Inc.) was developed for a hypothetical base case parturient presenting with a term singleton breech fetus with no contraindications for vaginal delivery. The model incorporated actual hospital costs (e.g., $8,023 for cesarean and $5,581 for vaginal delivery), utilities to quantify health-related quality of life, and probabilities based on analysis of published literature of successful ECV trial, spontaneous reversion, mode of delivery, and need for unanticipated emergency cesarean delivery. The primary endpoint was the incremental cost-effectiveness ratio in dollars per quality-adjusted year of life gained. A threshold of $50,000 per quality-adjusted life-years (QALY) was used to determine cost-effectiveness. The incremental cost-effectiveness of ECV, assuming a baseline 58% success rate, equaled $7,900/QALY. If the estimated probability of successful ECV is less than 32%, then ECV costs more to society and has poorer QALYs for the patient. However, as the probability of successful ECV was between 32% and 63%, ECV cost more than cesarean delivery but with greater associated QALY such that the cost-effectiveness ratio was less than $50,000/QALY. If the probability of successful ECV was greater than 63%, the computer modeling indicated that a trial of ECV is less costly and with better QALYs than a scheduled cesarean. The cost-effectiveness of a trial of ECV is most sensitive to its probability of success, and not to the probabilities of a cesarean after ECV, spontaneous reversion to breech, successful second ECV trial, or adverse

  5. Cost-effectiveness of external cephalic version for term breech presentation

    Directory of Open Access Journals (Sweden)

    Carvalho Brendan

    2010-01-01

    Full Text Available Abstract Background External cephalic version (ECV is recommended by the American College of Obstetricians and Gynecologists to convert a breech fetus to vertex position and reduce the need for cesarean delivery. The goal of this study was to determine the incremental cost-effectiveness ratio, from society's perspective, of ECV compared to scheduled cesarean for term breech presentation. Methods A computer-based decision model (TreeAge Pro 2008, Tree Age Software, Inc. was developed for a hypothetical base case parturient presenting with a term singleton breech fetus with no contraindications for vaginal delivery. The model incorporated actual hospital costs (e.g., $8,023 for cesarean and $5,581 for vaginal delivery, utilities to quantify health-related quality of life, and probabilities based on analysis of published literature of successful ECV trial, spontaneous reversion, mode of delivery, and need for unanticipated emergency cesarean delivery. The primary endpoint was the incremental cost-effectiveness ratio in dollars per quality-adjusted year of life gained. A threshold of $50,000 per quality-adjusted life-years (QALY was used to determine cost-effectiveness. Results The incremental cost-effectiveness of ECV, assuming a baseline 58% success rate, equaled $7,900/QALY. If the estimated probability of successful ECV is less than 32%, then ECV costs more to society and has poorer QALYs for the patient. However, as the probability of successful ECV was between 32% and 63%, ECV cost more than cesarean delivery but with greater associated QALY such that the cost-effectiveness ratio was less than $50,000/QALY. If the probability of successful ECV was greater than 63%, the computer modeling indicated that a trial of ECV is less costly and with better QALYs than a scheduled cesarean. The cost-effectiveness of a trial of ECV is most sensitive to its probability of success, and not to the probabilities of a cesarean after ECV, spontaneous reversion

  6. Vaginal delivery versus cesarean section for term breech delivery

    Directory of Open Access Journals (Sweden)

    Babović Ivana

    2010-01-01

    Full Text Available Background/Aim. The optimal method of delivery for breech presentation at term still remains a matter of controversy. This is probably due to the fact that the skills of vaginal breech delivery are being lost. The aim of this study was to examine risk factors: mother's age, parity, labor's duration, estimated neonatal birth weight for the mode of breech presentation delivery at term as well as the influence of the delivery mode on neonatal outcome. Methods. A retrospective study of 401 terms (more than 37 week's gestation breech deliveries at the Institute of Gynecology and Obstetrics, Belgrade, from 2007 to 2008 was made. The following groups with respect to mode of delivery were included: the group I - vaginal delivery (VD in 139 patients; the group II - urgent cesarean section (UCS in 128 patients; and the group III - elective cesarean section (ECS in 134 patients. Mother's age, parity, duration of VD, neonatal birth weight (BW, the Apgar score at 5th minute, and duration of stay in a neonatal intensive care unit (NICU vere determined. Neonatal mortality and major neonatal morbidity were compared according to the route of delivery. Fetuses and neonates with hemolytic disease and fetal and neonatal anomalies were excluded from the study. For statistical analyses we performed Student's t test, χ2 likelihood ratio, Kruskall-Wallis test, Mann Whitney test, and ANOVA. Results. The mean age of patients in the group I was 28.29 ± 4.97 years, in the group II 29.68 ± 5.92 years and in the group III 30.06 ± 5.41 years. Difference in mother's age between the group I and III was significant (p = 0.022. In the group III there were 73.9% nuliparous similarly to the gropu II (73.4%. We performed ECS in 54.6% of the nuliparous older than 35 years, and 54.4% multiparous younger than 35 years were delivered by VD. The use of oxytocin for stimulation of vaginal labor was not associated with its duration (p = 0.706. Lowset maneuver was performed in 88.5% of

  7. Long-term follow-up of cognitive outcome after breech presentation at birth

    DEFF Research Database (Denmark)

    Sørensen, Henrik Toft; Steffensen, Flemming Hald; Olsen, Jørn

    1999-01-01

    Studies of long-term consequences of birth in breech presentation are sparse. Therefore, we conducted a cohort study linking birth registry data with data collected during evaluation for military service in 4,298 conscripts born between 1973 and 1976. The cognitive functions were measured...... with the Boerge Prien IQ test. A total of 164 conscripts were born in breech presentation and 70 (42.7%) of these were delivered after Caesarean section. The mean Boerge Prien test score was 43.2 among men born in cephalic presentation and 39.9 among those born in breech presentation for a difference of 3.3 (95......% confidence interval = 1.8-4.7). The negative association between breech presentation and cognitive outcome persisted after stratifying by Caesarean section and after adjustment for confounders. It also persisted when we restricted the analyses to term singleton pregnancies....

  8. External cephalic version for breech presentation at term. A prospective interventional study.

    Science.gov (United States)

    Al-Jwadi, Saja A; Al-Ibrahim, Baraa L Humo

    2014-08-01

    To evaluate the external cephalic version (ECV) procedure for the management of at term breech presenting fetuses. In this prospective, interventional study, 90 patients with uncomplicated breech presentations at or after 37 weeks' gestation were considered for ECV. This was performed in Al-Batool Teaching Hospital, Mosul, Iraq, between January 2011 and March 2012. The main outcome measure was assessed as the success rate of ECV attempt and the rate of cesarean section following a successful procedure. Parity, type of breech, placental location, and birth weight were evaluated as predictors of success. Also, any fetal or maternal complications during the procedure were evaluated. Data were analyzed by x2 test. Statistical significance was determined at a level of pbreech. There were no serious fetal or maternal complications associated with the attempt. With appropriate selection of patients, ECV is highly successful and is a safer alternative to vaginal breech delivery or cesarean delivery.

  9. Interventions to help external cephalic version for breech presentation at term.

    Science.gov (United States)

    Hofmeyr, G J

    2004-01-01

    Breech presentation places a fetus at increased risk. The outcome for the baby is improved by planned caesarean section compared with planned vaginal delivery. External cephalic version attempts to reduce the chances of breech presentation at birth, but is not always successful. Tocolytic drugs to relax the uterus as well as other methods have been used in an attempt to facilitate external cephalic version at term. To assess the effects of routine tocolysis, fetal acoustic stimulation, epidural or spinal analgesia and transabdominal amnioinfusion for external cephalic version at term on successful version and measures of pregnancy outcome. The Cochrane Pregnancy and Childbirth Group trials register (September 2003) and the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 3, 2003) were searched. Randomised and quasi-randomised trials comparing routine versus selective or no tocolysis; fetal acoustic stimulation in midline fetal spine positions versus dummy or no stimulation; epidural or spinal analgesia versus no regional analgesia; or transabdominal amnioinfusion versus no amnioinfusion for external cephalic version at term. The reviewer assessed eligibility and trial quality. In six trials, routine tocolysis with beta-stimulants was associated with fewer failures of external cephalic version (relative risk (RR) 0.74, 95% confidence interval (CI) 0.64 to 0.87). The reduction in non-cephalic presentations at birth was not statistically significant. Caesarean sections were reduced (RR 0.85, 95% CI 0.72 to 0.99). In four small trials, sublingual nitroglycerine used as a tocolytic was associated with significant side-effects, and was not found to be effective. Fetal acoustic stimulation in midline fetal spine positions was associated with fewer failures of external cephalic version at term (RR 0.17, 95% CI 0.05 to 0.60). With epidural or spinal analgesia, external cephalic version failure, non-cephalic births and caesarean sections were

  10. The relation of breech presentation at term to cerebral palsy

    DEFF Research Database (Denmark)

    Krebs, L; Topp, M; Langhoff-Roos, J

    1999-01-01

    OBJECTIVE: To examine the relation between breech delivery and cerebral palsy, considering the influence of intrauterine growth, low Apgar score at birth, and mode of delivery. DESIGN: Register-based, case-control study. POPULATION: A cohort of infants with cerebral palsy born between 1979 and 1986...... in East Denmark, identified by linkage of the cerebral palsy register with the national birth register. Discharge letters from births of breech infants with cerebral palsy were reviewed. MAIN OUTCOME MEASURES: Presentation, mode of delivery, gestational age, birthweight, Apgar score, type of cerebral...

  11. Maternal deaths after elective cesarean section for breech presentation in the Netherlands

    NARCIS (Netherlands)

    Schutte, Joke M.; Steegers, Eric A. P.; Santema, Job G.; Schuitemaker, Nico W. E.; Van Roosmalen, Jos

    2007-01-01

    Background and methods. The cesarean section rate for term singleton breech babies in the Netherlands rose from 57 to 81% after the Term Breech Trial in 2000. The Dutch Maternal Mortality Committee registered and evaluated maternal mortality due to elective cesarean section for breech. Results. Four

  12. Breech presentation at a district level hospital in South Africa

    African Journals Online (AJOL)

    2009-03-05

    Mar 5, 2009 ... The results of the Term Breech Trial led the researchers to conclude that the combined ... and methodology of the Term Breech Trial6 and suggestions made that .... gestation), giving an incidence of 2.4%. Three hundred and ...

  13. Breech at term--mode of delivery? A register-based study

    DEFF Research Database (Denmark)

    Krebs, L; Langhoff-Roos, J; Weber, Tom

    1995-01-01

    ) when compared to those delivered by elective cesarean section. In vaginal deliveries, parity was not correlated with outcome, but infants with a birth weight above 4000 grams had significantly higher rates of low Apgar scores. CONCLUSIONS. Register data on singleton term breech deliveries imply......BACKGROUND. The present study was designed to determine neonatal mortality and morbidity in non-malformed singleton term infants delivered in breech presentation and identify a possible correlation between outcome on the one hand and mode of delivery, parity and birth weight on the other. METHODS....... Register-based cohort study of all (n = 15718) singleton term breech deliveries of non-malformed infants in Denmark 1982-1990. Process and outcome measures: mode of delivery, gestational age, birth weight, congenital malformations, intrapartum death, Apgar scores and early neonatal death. RESULTS. A total...

  14. Systematic review of adverse outcomes of external cephalic version and persisting breech presentation at term.

    Science.gov (United States)

    Nassar, Natasha; Roberts, Christine L; Barratt, Alexandra; Bell, Jane C; Olive, Emily C; Peat, Brian

    2006-03-01

    The aim of this study was to determine the frequency of adverse maternal and fetal outcomes of both external cephalic version (ECV) and persisting breech presentation at term. We conducted a systematic review of the literature using Medline, Embase and All Evidence Based Medicine (EBM) Reviews databases. Data were extracted from studies that compared women who had an ECV from 36 weeks' gestation with a similar control group of women enrolled at the same gestational age, eligible for, but who did not have an ECV. Eleven studies with a total of 2503 women were included. Adverse outcomes related to ECV were rarely reported and in most studies there was no evidence that relevant outcomes were ascertained among similar women who did not have an ECV. There was no increased risk of antepartum fetal death associated with ECV, but numbers were small. There were no reported cases of uterine rupture, placental abruption, prelabour rupture of membranes or cord prolapse, but these outcomes were not examined among controls. Onset of labour within 24 h and nuchal cord was non-significantly higher among women who had an ECV compared with those with a persisting breech. Despite limited reporting and small numbers, the results of our review suggest that adverse maternal and fetal outcomes of both ECV and persisting breech presentation are rare. Only with improved reporting and collection of safety data on ECV and persisting breech presentation can we provide high-quality information to assist informed decision making by pregnant women with a breech presentation at term.

  15. External cephalic version facilitation for breech presentation at term.

    Science.gov (United States)

    Hofmeyr, G J

    2001-01-01

    Tocolytic drugs to relax the uterus as well as other methods have been also used in an attempt to facilitate external cephalic version at term. The objective of this review is to assess the effects of routine tocolysis, fetal acoustic stimulation, epidural or spinal analgesia and transabdominal amnioinfusion for external cephalic version at term on successful version and measures of pregnancy outcome. The Cochrane Pregnancy and Childbirth Group Trials Register and the Cochrane Controlled Trials Register were searched. Date of last search: April 2001. Randomised and quasi-randomised trials comparing routine versus selective tocolysis; fetal acoustic stimulation in midline fetal spine positions versus dummy or no stimulation; epidural or spinal analgesia versus no regional analgesia; or transabdominal amnioinfusion versus no amnioinfusion for external cephalic version at term. Eligibility and trial quality were assessed by the reviewer. In seven trials, routine tocolysis was associated with fewer failures of external cephalic version (relative risk 0.74, 95% confidence interval 0.64 to 0.87). There were no significant differences between non-cephalic presentations at birth. Caesarean sections were reduced (relative risk 0.85, confidence interval 0.72-0.99). Fetal acoustic stimulation in midline fetal spine positions was associated with fewer failures of external cephalic version at term (relative risk 0.17, 95% confidence interval 0.05 to 0.60). With epidural or spinal analgesia, external cephalic version failure, non-cephalic births and caesarean sections were reduced in one trial but not the other. The overall differences were not statistically significant. No randomised trials of transabdominal amnioinfusion for external cephalic version at term were located. Routine tocolysis appears to reduce the failure rate of external cephalic version at term. Although promising, there is not enough evidence to evaluate the use of fetal acoustic stimulation in midline fetal

  16. Factors associated with the success of external cephalic version (ECV) of breech presentation at term.

    Science.gov (United States)

    Obeidat, N; Lataifeh, I; Al-Khateeb, M; Zayed, F; Khriesat, W; Amarin, Z

    2011-01-01

    To evaluate the predictors of success of ECV for breech presentation at term. A retrospective study was conducted over a 3-year period from 2005-2007, where 101 patients who had singleton breech presentation at term were undergoing external cephalic version (ECV) after 37 weeks of gestation at two major teaching hospitals in the North of Jordan. Comparative analysis was made between the successful ECV and unsuccessful ECV groups. The collected data were analysed by using statistical analysis Sudent's t-test and Mann-Whitney test as appropriate and on discrete results chi square or Fisher's exact test when appropriate. The differences were considered significant at a p value of breeches (74% vs 26%, p = 0.002), posterior placenta (38.6% vs 16.4%, p = 0.0001) and anterior fetal back (53.4% vs 34.8%, p = 0.03). Once turned the babies remained cephalic until delivery. All the 28 cases who had failed ECV had caesarean section. Among those who had a successful external cephalic version, the incidence of intrapartum caesarean section was only 8.2% which was lower than that of the average of both units caesarean rate (28%). There were no complications related to the ECV procedure in the study. Multiparity, flexed breech, posterior placenta, and anterior foetal back were the most favourable factors for successful ECV in our study. Moreover, with careful evaluation of individual predictors patient selection and success rates can be optimised.

  17. Uptake of external cephalic version for term breech presentation: an Australian population study, 2002-2012.

    Science.gov (United States)

    Bin, Yu Sun; Roberts, Christine L; Nicholl, Michael C; Ford, Jane B

    2017-07-26

    The safety, efficacy, and cost-effectiveness of external cephalic version (ECV) for term breech presentation has been demonstrated. Clinical guidelines recommend ECV for all eligible women, but the uptake of this procedure in the Australian healthcare setting is unknown. This study aimed to describe ECV uptake in New South Wales, the most populous state of Australia, during 2002 to 2012. Data from routine hospital and birth records were used to identify ECVs conducted at ≥36 weeks' gestation. Women with ECV were compared to women who were potentially eligible for but did not have ECV. Eligibility for ECV was based on clinical guidelines. For those with ECV, birth outcomes following successful and unsuccessful procedures were examined. In N = 32,321 singleton breech pregnancies, 10.5% had ECV, 22.3% were ineligible, and 67.2% were potentially eligible but did not undergo ECV. Compared to women who were eligible but who did not attempt ECV, those who had ECV were more likely to be older, multiparous, overseas-born, public patients at delivery, and to deliver in tertiary hospitals in urban areas (p < 0.01). Fewer women who underwent ECV smoked during pregnancy, fewer were morbidly obese, and fewer had a hypertensive disorder of pregnancy, compared to those who were eligible. Caesarean section occurred in 25.9% of successful compared to 95.6% of unsuccessful ECVs. Infant outcomes did not differ by ECV success. The majority of women with a breech presentation did not receive ECV. It is unclear whether this is attributable to issues with service provision or low acceptability among women. Policies to improve access to and information about ECV appear necessary to improve uptake among women with term breech presentation. Improved data collection around the diagnosis of breech presentation, ECV attempts, and outcomes may help to identify specific barriers to ECV uptake.

  18. Breech at term--mode of delivery? A register-based study

    DEFF Research Database (Denmark)

    Krebs, L; Langhoff-Roos, J; Weber, Tom

    1995-01-01

    . Register-based cohort study of all (n = 15718) singleton term breech deliveries of non-malformed infants in Denmark 1982-1990. Process and outcome measures: mode of delivery, gestational age, birth weight, congenital malformations, intrapartum death, Apgar scores and early neonatal death. RESULTS. A total...... of 3247 (20.7%) term infants were delivered vaginally, 7106 (45.3%) by elective and 5356 (34.1%) by emergency cesarean section. Infants delivered vaginally and by emergency cesarean section had significantly higher rates of mortality (intrapartum and early neonatal death) and morbidity (low Apgar scores......) when compared to those delivered by elective cesarean section. In vaginal deliveries, parity was not correlated with outcome, but infants with a birth weight above 4000 grams had significantly higher rates of low Apgar scores. CONCLUSIONS. Register data on singleton term breech deliveries imply...

  19. Interventions for helping to turn term breech babies to head first presentation when using external cephalic version

    Science.gov (United States)

    Cluver, Catherine; Hofmeyr, G Justus; Gyte, Gillian ML; Sinclair, Marlene

    2014-01-01

    Background Breech presentation is associated with increased complications. Turning a breech baby to head first presentation using external cephalic version (ECV) attempts to reduce the chances of breech presentation at birth, and reduce the adverse effects of breech vaginal birth or caesarean section. Tocolytic drugs and other methods have been used in an attempt to facilitate ECV. Objectives To assess interventions such as tocolysis, fetal acoustic stimulation, regional analgesia, transabdominal amnioinfusion or systemic opioids on ECV for a breech baby at term. Search methods We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (30 September 2011) and the reference lists of identified studies. Selection criteria Randomised and quasi-randomised trials comparing the above interventions with no intervention or other methods to facilitate ECV at term. Data collection and analysis We assessed eligibility and trial quality. Two review authors independently assessed for inclusion all potential studies identified as a result of the search strategy and independently extracted the data using a designed data extraction form. Main results We included 25 studies, providing data on 2548 women. We used the random-effects model for pooling data due to clinical heterogeneity in the included studies in the various comparisons. The overall quality of the evidence was reasonable, but a number of assessments had insufficient data to provide an answer with any degree of assurance. Tocolytic drugs, in particular betastimulants, were effective in increasing cephalic presentations in labour (average risk ratio (RR) 1.38, 95% confidence interval (CI) 1.03 to 1.85, eight studies, 993 women) and in reducing the number of caesarean sections (average RR 0.82, 95% CI 0.71 to 0.94, eight studies, 1177 women). No differences were identified in fetal bradycardias (average RR 0.95, 95% CI 0.48 to 1.89, three studies, 467 women) although the review is underpowered for

  20. Contraindications for external cephalic version in breech position at term: a systematic review.

    Science.gov (United States)

    Rosman, Ageeth N; Guijt, Aline; Vlemmix, Floortje; Rijnders, Marlies; Mol, Ben W J; Kok, Marjolein

    2013-02-01

    External cephalic version (ECV) is a safe and effective intervention that can prevent breech delivery, thus reducing the need for cesarean delivery. It is recommended in national guidelines. These guidelines also mention contraindications for ECV, and thereby restrict the application of ECV. We assessed whether the formulation of these contraindications in guidelines are based on empiric data. Systematic review. Pregnant women with a singleton breech presentation from 34 weeks. We searched the National Guideline Clearinghouse, the Cochrane Central Register of Controlled Trials, MEDLINE (1953-2009), EMBASE (1980-2009), TRIP database (until 2011), NHS (National Health Services, until 2011), Diseases database (until 2011) and NICE guidelines (until 2011) for existing guidelines on ECV and studied the reproducibility of the contraindications stated in the guidelines. Furthermore, we systematically reviewed the literature for contraindications and evidence on these contraindications. Contraindications of ECV. We found five guidelines mentioning 18 contraindications, varying from five to 13 per guideline. The contraindications were not reproducible between the guidelines with oligohydramnios as the only contraindication mentioned in all guidelines. The literature search yielded 60 studies reporting on 39 different contraindications, of which we could only assess evidence of six of them. The present study shows that there is no general consensus on the eligibility of patients for ECV. Therefore we propose to limit contraindications for ECV to clear empirical evidence or to those with a clear pathophysiological relevance. © 2012 The Authors Acta Obstetricia et Gynecologica Scandinavica© 2012 Nordic Federation of Societies of Obstetrics and Gynecology.

  1. How singleton breech babies at term are born in France: a survey of data from the AUDIPOG network.

    Science.gov (United States)

    Lansac, J; Crenn-Hebert, C; Rivière, O; Vendittelli, F

    2015-05-01

    Based on data from the AUDIPOG sentinel network between 1994 and 2010, we can say that the rate of singleton breech presentation at term is 3% and remains unchanged despite an external cephalic version rate of 35%. The total cesarean section rate is currently 75%. This rate increased by nearly 20% after the Hannah publication in 2000, regardless of the type of breech and type of maternity unit. The rate of planned cesarean sections increased in particular, going from 40% to 60%, and even reaching 67% for footling breech presentations. The rate is higher in type I maternity units than in type II or III. This cesarean section rate has been stable since 2005 and has even decreased for the Frank breech. The average rate of external cephalic version remains stable at around 23%. The episiotomy rate is 28%. The rate of babies transferred to neonatology units is higher for breech babies at term than for babies presenting cephalically (3.9% compared to 2.9%), but the newborns most often transferred are those born by cesarean section (4.1% compared to 3.4%). Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  2. A prospective study of the factors associated with the success rate of external cephalic version for breech presentation at term.

    Science.gov (United States)

    Burgos, Jorge; Melchor, Juan Carlos; Pijoán, José Ignacio; Cobos, Patricia; Fernández-Llebrez, Luis; Martínez-Astorquiza, Txantón

    2011-01-01

    To determine the factors associated with the success rate of external cephalic version (ECV) for breech presentation at term. A prospective analysis of 500 ECV maneuvers. The variables maternal age, maternal weight, body mass index, previous cesarean delivery, gestational age, parity, amount of amniotic fluid, placental location, and type of breech were studied using logistic regression analysis. The success rate of ECV was 52.2% (n=261). The variables significantly associated with success were parity, placental location, amount of amniotic fluid, and type of breech (Pbreech presentation had a 2.77-times higher success rate compared with a frank breech presentation (95% CI, 1.16-6.62). The area under the ROC curve showed a predictive ability of 73.6% (95% CI, 69.2%-77.9%) for these 3 variables. Parity, placental location, amount of amniotic fluid, and type of breech presentation were associated with the success rate of ECV. Copyright © 2010 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

  3. Patients' and professionals' barriers and facilitators to external cephalic version for breech presentation at term, a qualitative analysis in the Netherlands

    NARCIS (Netherlands)

    Rosman, A. N.; Vlemmix, F.; Fleuren, M. A H; Rijnders, M. E.; Beuckens, A.; Opmeer, Brent C; Mol, B.W.J.; van Zwieten, M.C.B.; Kok, M.

    Objective: external cephalic version (ECV) is a relatively simple and safe manoeuvre and a proven effective approach in the reduction of breech presentation at term. There is professional consensus that ECV should be offered to all women with a fetus in breech presentation, but only up to 70% of

  4. Patients' and professionals' barriers and facilitators to external cephalic version for breech presentation at term, a qualitative analysis in the Netherlands

    NARCIS (Netherlands)

    Rosman, A. N.; Vlemmix, F.; Fleuren, M. A. H.; Rijnders, M. E.; Beuckens, A.; Opmeer, B. C.; Mol, B. W. J.; van Zwieten, M. C. B.; Kok, M. [=Marjolein

    2014-01-01

    external cephalic version (ECV) is a relatively simple and safe manoeuvre and a proven effective approach in the reduction of breech presentation at term. There is professional consensus that ECV should be offered to all women with a fetus in breech presentation, but only up to 70% of women eligible

  5. Patients' and professionals' barriers and facilitators to external cephalic version for breech presentation at term, a qualitative analysis in the Netherlands

    NARCIS (Netherlands)

    Rosman, A.N.; Vlemmix, F.; Fleuren, M.A.H.; Rijnders, M.E.; Beuckens, A.; Opmeer, B.C.; Mol, B.W.J.; Zwieten, M.C.B. van; Kok, M.

    2014-01-01

    Objective: external cephalic version (ECV) is a relatively simple and safe manoeuvre and a proven effective approach in the reduction of breech presentation at term. There is professional consensus that ECV should be offered to all women with a fetus in breech presentation, but only up to 70% of

  6. [External cephalic version for breech presentation at term: an effective procedure to reduce the caesarean section rate].

    Science.gov (United States)

    Lojacono, A; Donarini, G; Valcamonico, A; Soregaroli, M; Frusca, T

    2003-12-01

    Although term breech presentation is a relatively rare condition (3-5% of all births), it continues to be an important indication for caesarean section and has contributed to its increased use. Risk of complications may be increased for both mother and foetus in such a situation. Vaginal delivery of a breech presenting foetus is complex and may involve many difficulties, so today there is a general consensus that planned caesarean section is better than planned vaginal birth for the foetus in breech presentation at term. External cephalic version is one of the most effective procedures in modern obstetrics. It involves the external manipulation of the foetus from the breech into the cephalic presentation. A successful manoeuvre can decrease costs by avoiding operative deliveries and decreasing maternal morbidity. The aim of the present study is to evaluate the effectiveness of this obstetric manoeuvre to increase the proportion of vertex presentation among foetuses that were formerly in the breech position near term, so as to reduce the caesarean section rate. The safety of the version is also showed. From 1999 to 2002, 89 women with foetal breech presentation underwent external cephalic version at the Department of Obstetrics and Gynaecology of the Brescia University. The gestational age was 36.8+/-0.8 weeks. The following variables have been taken into consideration: breech variety, placental location, foetal back position, parity, amount of amniotic fluid and gestational age. Every attempt was performed with a prior use of an intravenous drip of Ritodrine, and foetal heart rate was monitored continuously with cardiotocogram. The success rate of the procedure was 42.7% (n=38). No maternal or foetal complication or side effects occurred, both during and after the manoeuvre, except a transient foetal bradycardia that resolved spontaneously. Only one spontaneous reversion of the foetus occurred before delivery. Of all the women that underwent a successful version

  7. Amnioinfusion for women with a singleton breech presentation and a previous failed external cephalic version: a randomized controlled trial.

    Science.gov (United States)

    Diguisto, Caroline; Winer, Norbert; Descriaud, Celine; Tavernier, Elsa; Weymuller, Victoire; Giraudeau, Bruno; Perrotin, Franck

    2018-04-01

    Our trial aimed to assess the effectiveness of amnioinfusion for a second attempt at external cephalic version (ECV). This open randomized controlled trial was planned with a sequential design. Women at a term ≥36 weeks of gestation with a singleton fetus in breech presentation and a first unsuccessful ECV were recruited in two level-3 maternity units. They were randomly allocated to transabdominal amnioinfusion with a 500-mL saline solution under ultrasound surveillance or no amnioinfusion before the second ECV attempt. Trained senior obstetricians performed all procedures. The primary outcome was the cephalic presentation rate at delivery. Analyses were conducted according to intention to treat (NCT00465712). Recruitment difficulties led to stopping the trial after a 57-month period, 119 women were randomized: 59 allocated to amnioinfusion + ECV and 60 to ECV only. Data were analyzed without applying the sequential feature of the design. The rate of cephalic presentation at delivery did not differ significantly according to whether the second version attempt was or was not preceded by amnioinfusion (20 versus 12%, p = .20). Premature rupture of the membranes occurred for 15% of the women in the amnioinfusion group. Amnioinfusion before a second attempt to external version does not significantly increase the rate of cephalic presentation at delivery.

  8. Fear for external cephalic version and depression : Predictors of successful external cephalic version for breech presentation at term?

    NARCIS (Netherlands)

    Ciliacus, Emily; van der Zalm, Marieke; Truijens, Sophie E.; Hasaart, Tom H.; Pop, Victor J.; Kuppens, Simone M.

    2014-01-01

    Background Objective was to determine whether fear for external cephalic version (ECV) and depression are associated with the success rate of ECV in women with a breech presentation at term. Methods Prospective study conducted in the Catharina Hospital Eindhoven between October 2007 and May 2012.

  9. Interventions for helping to turn term breech babies to head first presentation when using external cephalic version.

    Science.gov (United States)

    Cluver, Catherine; Gyte, Gillian M L; Sinclair, Marlene; Dowswell, Therese; Hofmeyr, G Justus

    2015-02-09

    Breech presentation is associated with increased complications. Turning a breech baby to head first presentation using external cephalic version (ECV) attempts to reduce the chances of breech presentation at birth so as to avoid the adverse effects of breech vaginal birth or caesarean section. Interventions such as tocolytic drugs and other methods have been used in an attempt to facilitate ECV. To assess, from the best evidence available, the effects of interventions such as tocolysis, acoustic stimulation for midline spine position, regional analgesia (epidural or spinal), transabdominal amnioinfusion, systemic opioids and hypnosis, or the use of abdominal lubricants, on ECV at term for successful version, presentation at birth, method of birth and perinatal and maternal morbidity and mortality. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 September 2014) and the reference lists of identified studies. Randomised and quasi-randomised trials comparing the above interventions with no intervention or other methods to facilitate ECV at term. We assessed eligibility and trial quality. Two review authors independently assessed for inclusion all potential studies identified as a result of the search strategy and independently extracted the data using a specially designed data extraction form. We included 28 studies, providing data on 2786 women. We used the random-effects model for pooling data because of clinical heterogeneity between studies. A number of trial reports gave insufficient information to allow clear assessment of risk of bias. We used GradePro software to carry out formal assessments of quality of the evidence for beta stimulants versus placebo and regional analgesia with tocolysis versus tocolysis alone.Tocolytic parenteral beta stimulants were effective in increasing cephalic presentations in labour (average risk ratio (RR) 1.68, 95% confidence interval (CI) 1.14 to 2.48, five studies, 459 women, low-quality evidence) and

  10. Delivery mode and neonatal outcome after a trial of external cephalic version (ECV): a prospective trial of vaginal breech versus cephalic delivery.

    Science.gov (United States)

    Reinhard, Joscha; Sänger, Nicole; Hanker, Lars; Reichenbach, Lena; Yuan, Juping; Herrmann, Eva; Louwen, Frank

    2013-04-01

    To examine the delivery mode and neonatal outcome after a trial of external cephalic version (ECV) procedures. This is an interim analysis of an ongoing larger prospective off-centre randomised trial, which compares a clinical hypnosis intervention against neuro-linguistic programming (NLP) of women with a singleton breech foetus at or after 37(0/7) (259 days) weeks of gestation and normal amniotic fluid index. Main outcome measures were delivery mode and neonatal outcome. On the same day after the ECV procedure two patients (2 %), who had unsuccessful ECVs, had Caesarean sections (one due to vaginal bleeding and one due to pathological CTG). After the ECV procedure 40.4 % of women had cephalic presentation (n = 38) and 58.5 % (n = 55) remained breech presentation. One patient remained transverse presentation (n = 1; 1.1 %). Vaginal delivery was observed by 73.7 % of cephalic presentation (n = 28), whereas 26.3 % (n = 10) had in-labour Caesarean sections. Of those, who selected a trial of vaginal breech delivery, 42.4 % (n = 14) delivered vaginally and 57.6 % (n = 19) delivered via Caesarean section. There is a statistically significant difference between the rate of vaginal birth between cephalic presentation and trial of vaginal breech delivery (p = 0.009), however, no difference in neonatal outcome was observed. ECV is a safe procedure and can reduce not only the rate of elective Caesarean sections due to breech presentation but also the rate of in-labour Caesarean sections even if a trial of vaginal breech delivery is attempted.

  11. Remifentanil analgesia during external cephalic version for breech presentation in nulliparous women at term

    Science.gov (United States)

    Wang, Zhi-Hong; Yang, Yi; Xu, Gui-Ping

    2017-01-01

    Abstract Background: The aim of the study was to assess the efficacy and safety of remifentanil for pain relief during external cephalic version (ECV) for breech presentation in nulliparous women at term. Methods: A total of 144 nulliparous women with singleton breech presentation were randomly divided into the intervention group and the placebo group, with 72 subjects in each group. The subjects in the intervention group received remifentanil (infused at 0.1 μg kg–1 min–1 with demand boluses of 0.1 μg/kg), whereas those in the placebo group were given saline placebo. This study was conducted from May 2013 to April 2016. The outcomes measures include pain (measured with the visual analog scale, VAS), success rate of ECV, maternal satisfaction for ECV, and adverse events. Results: A total of 137 participants completed the study. The intervention with remifentanil showed greater efficacy than did placebo in decreasing the VAS score immediately after ECV (intervention group 4.3 ± 2.2 vs placebo group 6.4 ± 2.5, P < 0.01). A significant difference in the ECV success rate was also found between the 2 groups (intervention group 56.9% vs placebo group 38.9%, P = 0.03). In addition, a significant difference in the satisfaction score was also detected (intervention group 9.3 ± 0.9 vs placebo group 6.7 ± 1.2, P < 0.01). The observed adverse events were similar between the 2 groups. Conclusion: This study shows that remifentanil could decrease pain, improve the ECV success rate, and improve satisfaction in nulliparous women at term during the period of ECV. Furthermore, it is also well tolerated with few adverse events. PMID:28296735

  12. Fear for external cephalic version and depression: predictors of successful external cephalic version for breech presentation at term?

    Science.gov (United States)

    Ciliacus, Emily; van der Zalm, Marieke; Truijens, Sophie E; Hasaart, Tom H; Pop, Victor J; Kuppens, Simone M

    2014-03-12

    Objective was to determine whether fear for external cephalic version (ECV) and depression are associated with the success rate of ECV in women with a breech presentation at term. Prospective study conducted in the Catharina Hospital Eindhoven between October 2007 and May 2012. Participants fulfilled The Edinburgh Depression Scale (EDS) questionnaire and expressed their degree of fear on a visual analogue scale from one to ten before ECV. Obstetric factors were evaluated as well. Primary outcome was the relation between psychological factors (fear for ECV and depression EDS scores) and ECV success rate. Secondary outcome was a possible relation between fear for ECV and increased abdominal muscle tension. The overall success rate was 55% and was significantly lower (p < 0.001) in nulliparous women (44.3%) compared with parous women (78.0%). Fear for ECV and depression EDS-scores were not related with ECV success rate. Parity, placental location, BMI and engagement of the fetal breech were obstetric factors associated with ECV outcome. There was no relation between fear for ECV and abdominal muscle tone. Fear for ECV and depression were not related with ECV success rate in this study. Engagement of the fetal breech was the most important factor associated with a successful ECV. The Eindhoven Breech Intervention Study, NCT00516555.

  13. External cephalic version for breech presentation at term: predictors of success, and impact on the rate of caesarean section.

    Science.gov (United States)

    Hussin, O A; Mahmoud, M A; Abdel-Fattah, M M

    2013-02-01

    The incidence of caesarean section for breech presentation has increased markedly in the last 20 years. A prospective, interventional cohort study was carried out of the success rate of external cephalic version (ECV) and its predictors of as well as its impact on the rate of caesarean section for vaginal breech delivery. All 128 women admitted during the study period to the obstetrics department of a tertiary care military hospital in Taif, Saudi Arabia with breech presentation at term, regardless of age and parity, who accepted ECV were recruited. ECV was successful in 53.9% of the women. Most of the women with successful ECV delivered normally (84.1%) and only 14.5% of them delivered by caesarean section. Conversely, normal vaginal delivery was reported among 8.5% of those who had spontaneous version with failed ECV and approximately two-thirds of them delivered by caesarean section (62.7%). Successful ECV reduced the breech and caesarean section rate.

  14. External cephalic version of the term breech baboon (Papio sp.) fetus.

    Science.gov (United States)

    Barrier, Breton F; Joiner, Laura Lee Rihl; Jimenez, Joe B; Leland, M Michelle

    2007-06-01

    Breech presentation in baboons may be associated with head entrapment and stillbirth during vaginal delivery. For this reason, pregnant dams at our institution typically undergo cesarean delivery for known breech presentation, leading to problems with maternal-infant bonding and increased nursery utilization. This paper describes a simple, non-invasive technique called external cephalic version (ECV) that effectively converts the baboon breech fetus into a cephalic presentation. ECV was successful in each of seven attempted cases, with the consistent development of contractions and vaginal bleeding leading to the delivery of a healthy liveborn infant within 72 hours. ECV may offer a safe and effective alternative to cesarean section for delivery of the breech baboon fetus.

  15. Breech birth

    Science.gov (United States)

    ... page: //medlineplus.gov/ency/patientinstructions/000623.htm Breech birth To use the sharing features on this page, ... safer for your baby to pass through the birth canal. In the last weeks of pregnancy, your ...

  16. A novel and dedicated multidisciplinary service to manage breech presentation at term; 3 years of experience in a tertiary care maternity unit.

    Science.gov (United States)

    Hickland, Patrick; Gargan, Phyl; Simpson, Jacquie; McCabe, Niamh; Costa, Janitha

    2017-08-09

    In order to provide uniform and unbiased multidisciplinary counselling on the options available, including vaginal breech delivery (VBD) and external cephalic version (ECV), the latter of which could then be performed, a weekly Breech Clinic was introduced to a tertiary care maternity unit in Northern Ireland in June 2013, replacing the traditional ECV Clinic introduced in June 2012. Retrospective data collection was undertaken using clinic proformas, Northern Ireland Maternity System data and case notes of women who attended the clinics (ECV and Breech) from June 2012 to May 2015. There were 434 referrals to the clinic over the 3-year period; 356 women attended. The proportion of women attending increased from 69% to 85% since the introduction of the Breech Clinic. Two hundred and thirty-two were deemed eligible and 179 of these underwent ECV after counselling. Although the proportion of women undergoing ECV decreased from 69% to 46%, 11 women opted for and achieved VBD during the 2 years of the Breech Clinic, compared with one woman in the year of the ECV Clinic. Seventy-one of the attempted ECVs were successful, with 61 women having a normal vaginal delivery. Notably, the success rate of ECV increased from 33% to 42%. The number of caesarean sections performed solely for breech at term decreased from 199 in the 12 months before the introduction of ECV clinic, to 188 during the ECV clinic, and 154 in the final 12 months of Breech Clinic. A dedicated service to counsel women on the management of breech presentation can decrease caesarean sections for breech presentation through increased uptake and success of ECV, and encouraging suitable women to opt for VBD when ECV is unsuccessful, contraindicated or declined.

  17. [External cephalic version in case of persisting breech presentation at term: motivations and women's experience of the intervention].

    Science.gov (United States)

    Pichon, M; Guittier, M-J; Irion, O; Boulvain, M

    2013-01-01

    To evaluate the efficacy and acceptability of external cephalic version (ECV). From 2004 to 2008, 212 pregnant women between 34-37 weeks of gestation with fetus in breech presentation were included in a randomized clinical trial and 125 externals cephalic versions were studied. A success rate of 37.6%t was recorded. At 34 weeks of gestation, 80.6% of women were considering an ECV in the event of persistent breech position at 37 weeks. These women expressed the desire to give birth vaginally (52% versus 24.4%, P<0.001). In contrast, others women preferred an elective cesarean section to avoid the risk of a breech vaginal delivery. Women felt pain during the ECV and scored 60 on average using the analogical visual scale. Women rated on a verbal rating scale the ECV as severely painful to unbearable (68%), and as stressful (70%). Despite this, the majority of women would recommend ECV to their friends or would be willing to repeat it for themselves. ECV remains a scary and painful medical procedure. More research is needed to reduce the impact. The use of analgesic medication for this indication is controversial. Hypnosis could be an alternative to evaluate. Copyright © 2012 Elsevier Masson SAS. All rights reserved.

  18. Reverse breech extraction versus the standard approach of pushing the impacted fetal head up through the vagina in caesarean section for obstructed labour: A randomised controlled trial.

    Science.gov (United States)

    Nooh, Ahmed Mohamed; Abdeldayem, Hussein Mohammed; Ben-Affan, Othman

    2017-05-01

    The objective of this study was to assess effectiveness and safety of the reverse breech extraction approach in Caesarean section for obstructed labour, and compare it with the standard approach of pushing the fetal head up through the vagina. This randomised controlled trial included 192 women. In 96, the baby was delivered by the 'reverse breech extraction approach', and in the remaining 96, by the 'standard approach'. Extension of uterine incision occurred in 18 participants (18.8%) in the reverse breech extraction approach group, and 46 (47.9%) in the standard approach group (p = .0003). Two women (2.1%) in the reverse breech extraction approach group needed blood transfusion and 11 (11.5%) in the standard approach group (p = .012). Pyrexia developed in 3 participants (3.1%) in the reverse breech extraction approach group, and 19 (19.8%) in the standard approach group (p = .0006). Wound infection occurred in 2 women (2.1%) in the reverse breech extraction approach group, and 12 (12.5%) in the standard approach group (p = .007). Apgar score pushing the fetal head up through the vagina.

  19. Contraindications for external cephalic version in breech position at term: a systematic review

    NARCIS (Netherlands)

    Rosman, Ageeth N.; Guijt, Aline; Vlemmix, Floortje; Rijnders, Marlies; Mol, Ben W. J.; Kok, Marjolein

    2013-01-01

    External cephalic version (ECV) is a safe and effective intervention that can prevent breech delivery, thus reducing the need for cesarean delivery. It is recommended in national guidelines. These guidelines also mention contraindications for ECV, and thereby restrict the application of ECV. We

  20. Contraindications for external cephalic version in breech position at term: A systematic review

    NARCIS (Netherlands)

    Rosman, A.N.; Guijt, A.; Vlemmix, F.; Rijnders, M.; Mol, B.W.J.; Kok, M.

    2013-01-01

    Objective. External cephalic version (ECV) is a safe and effective intervention that can prevent breech delivery, thus reducing the need for cesarean delivery. It is recommended in national guidelines. These guidelines also mention contraindications for ECV, and thereby restrict the application of

  1. Women's experiences of planning a vaginal breech birth in Australia.

    Science.gov (United States)

    Homer, Caroline Se; Watts, Nicole P; Petrovska, Karolina; Sjostedt, Chauncey M; Bisits, Andrew

    2015-04-11

    In many countries, planned vaginal breech birth (VBB) is a rare event. After the Term Breech Trial in 2000, VBB reduced and caesarean section for breech presentation increased. Despite this, women still request VBB. The objective of this study was to explore the experiences and decision-making processes of women who had sought a VBB. A qualitative study using descriptive exploratory design was undertaken. Twenty-two (n = 22) women who planned a VBB, regardless of eventual mode of birth were recruited. The women had given birth at one of two maternity hospitals in Australia that supported VBB. In-depth, semi-structured interviews using an interview guide were conducted. Interviews were analysed thematically. Twenty two women were interviewed; three quarters were primiparous (n = 16; 73%). Nine (41%) were already attending a hospital that supported VBB with the remaining women moving hospitals. All women actively sought a vaginal breech birth because the baby remained breech after an external cephalic version - 12 had a vaginal birth (55%) and 10 (45%) a caesarean section after labour commenced. There were four main themes: Reacting to a loss of choice and control, Wanting information that was trustworthy, Fighting the system and seeking support for VBB and The importance of 'having a go' at VBB. Women seeking a VBB value clear, consistent and relevant information in deciding about mode of birth. Women desire autonomy to choose vaginal breech birth and to be supported in their choice with high quality care.

  2. The effects of the term breech trial on vaginal breech delivery 8 years on

    LENUS (Irish Health Repository)

    Hehir, MP

    2011-02-01

    Institute of Obstetricians & Gynaecologists, RCPI Four Provinces Meeting, Junior Obstetrics & Gynaecology Society Annual Scientific Meeting, Royal Academy of Medicine in Ireland Dublin Maternity Hospitals Reports Meeting, Nov 2011

  3. Outcomes of external cephalic version and breech presentation at term, an audit of deliveries at a Sydney tertiary obstetric hospital, 1997-2004.

    Science.gov (United States)

    Nassar, Natasha; Roberts, Christine L; Cameron, Carolyn A; Peat, Brian

    2006-01-01

    Probabilistic information on outcomes of breech presentation is important for clinical decision-making. We aim to quantify adverse maternal and fetal outcomes of breech presentation at term. We conducted an audit of 1,070 women with a term, singleton breech presentation who were classified as eligible or ineligible for external cephalic version or diagnosed in labor at a tertiary obstetric hospital in Australia, 1997-2004. Maternal, delivery and perinatal outcomes were assessed and frequency of events quantified. Five hundred and sixty (52%) women were eligible and 170 (16%) were ineligible for external cephalic version, 211 (20%) women were diagnosed in labor and 134 (12%) were unclassifiable. Seventy-one percent of eligible women had an external cephalic version, with a 39% success rate. Adverse outcomes of breech presentation at term were rare: immediate delivery for prelabor rupture of membranes (1.3%), nuchal cord (9.3%), cord prolapse (0.4%), and fetal death (0.3%); and did not differ by clinical classification. Women who had an external cephalic version had a reduced risk of onset-of-labor within 24 h (RR 0.25; 95%CI 0.08, 0.82) compared with women eligible for but who did not have an external cephalic version. Women diagnosed with breech in labor had the highest rates of emergency cesarean section (64%), cord prolapse (1.4%) and poorest infant outcomes. Adverse maternal and fetal outcomes of breech presentation at term are rare and there was no increased risk of complications after external cephalic version. Findings provide important data to quantify the frequency of adverse outcomes that will help facilitate informed decision-making and ensure optimal management of breech presentation.

  4. Patients' and professionals' barriers and facilitators to external cephalic version for breech presentation at term, a qualitative analysis in the Netherlands.

    Science.gov (United States)

    Rosman, A N; Vlemmix, F; Fleuren, M A H; Rijnders, M E; Beuckens, A; Opmeer, B C; Mol, B W J; van Zwieten, M C B; Kok, M

    2014-03-01

    external cephalic version (ECV) is a relatively simple and safe manoeuvre and a proven effective approach in the reduction of breech presentation at term. There is professional consensus that ECV should be offered to all women with a fetus in breech presentation, but only up to 70% of women eligible for ECV undergo an ECV attempt. The aim of the study was to identify barriers and facilitators for ECV among professionals and women with a breech presentation at term. qualitative study with semi-structured interviews. Dutch hospitals. pregnant women with a breech presentation who had decided on ECV, and midwives and gynaecologists treating women with a breech presentation. on the basis of national guidelines and expert opinions, we developed topic lists to guide the interviews and discuss barriers and facilitators in order to decide on ECV (pregnant women) or advice on ECV (midwives and gynaecologists). among pregnant women the main barriers were fear, the preference to have a planned caesarean section (CS), incomplete information and having witnessed birth complications within the family or among friends. The main facilitators were the wish for a home birth, the wish for a vaginal delivery and confidence of the safety of ECV. Among professionals the main barriers were a lack of knowledge to fully inform and counsel patients on ECV, and the inability to counsel women who preferred a primary CS. The main facilitator was an unambiguous policy on (counselling for) ECV within the region. we identified several barriers and facilitators possibly explaining the suboptimal implementation of ECV for breech presentation in the Netherlands. This knowledge should be taken into account in designing implementation strategies for ECV to improve the uptake of ECV by professionals and patients. Copyright © 2013 Elsevier Ltd. All rights reserved.

  5. Facilitators and barriers to external cephalic version for breech presentation at term among health care providers in the Netherlands: a quantitative analysis

    NARCIS (Netherlands)

    Rosman, Ageeth N.; Vlemmix, Floortje; Beuckens, Antje; Rijnders, Marlies E.; Opmeer, Brent C.; Mol, Ben Willem J.; Kok, Marjolein; Fleuren, Margot A. H.

    2014-01-01

    guidelines recommend that external cephalic version (ECV) should be offered to all women with a fetus in breech presentation at term. However, only 50-60% of the women receive an ECV attempt. We explored the determinants (barriers and facilitators) affecting the uptake of the guidelines among

  6. Facilitators and barriers to external cephalic version for breech presentation at term among health care providers in the Netherlands: A quantitative analysis

    NARCIS (Netherlands)

    Rosman, A.N.; Vlemmix, F.; Beuckens, A.; Rijnders, M.E.; Opmeer, B.C.; Mol, B.W.J.; Kok, M.; Fleuren, M.A.H.

    2014-01-01

    OBJECTIVE: guidelines recommend that external cephalic version (ECV) should be offered to all women with a fetus in breech presentation at term. However, only 50-60% of the women receive an ECV attempt. We explored the determinants (barriers and facilitators) affecting the uptake of the guidelines

  7. Barriers and facilitators for vaginal breech births in Australia: Clinician's experiences.

    Science.gov (United States)

    Catling, C; Petrovska, K; Watts, N; Bisits, A; Homer, C S E

    2016-04-01

    Since the Term Breech Trial in 2000, few Australian clinicians have been able to maintain their skills to facilitate vaginal breech births. The overwhelming majority of women with a breech presentation have been given one birth option, that is, caesarean section. The aim of this study was to explore clinician's experiences of caring for women when facilitating a vaginal breech birth. A descriptive exploratory design was undertaken. Nine clinicians (obstetricians and midwives) from two tertiary hospitals in Australia who regularly facilitate vaginal breech birth were interviewed. The interviews were analysed thematically. Participants were five obstetricians and four midwives. There were two overarching themes that arose from the data: Facilitation of and Barriers to vaginal breech birth. A number of sub-themes are described in the paper. In order to facilitate vaginal breech birth and ensure it is given as an option to women, it is necessary to educate, upskill and support colleagues to increase their confidence and abilities, carefully counsel and select suitable women, and approach the option in a calm, collaborative way. Copyright © 2015 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.

  8. Maternal outcomes of term breech presentation delivery: impact of successful external cephalic version in a nationwide sample of delivery admissions in the United States.

    Science.gov (United States)

    Weiniger, Carolyn F; Lyell, Deirdre J; Tsen, Lawrence C; Butwick, Alexander J; Shachar, BatZion; Callaghan, William M; Creanga, Andreea A; Bateman, Brian T

    2016-07-08

    We aimed to define the frequency and predictors of successful external cephalic version in a nationally-representative cohort of women with breech presentations and to compare maternal outcomes associated with successful external cephalic version versus persistent breech presentation. Using the Nationwide Inpatient Sample, a United States healthcare utilization database, we identified delivery admissions between 1998 and 2011 for women who had successful external cephalic version or persistent breech presentation (including unsuccessful or no external cephalic version attempt) at term. Multivariable logistic regression identified patient and hospital-level factors associated with successful external cephalic version. Maternal outcomes were compared between women who had successful external cephalic version versus persistent breech. Our study cohort comprised 1,079,576 delivery admissions with breech presentation; 56,409 (5.2 %) women underwent successful external cephalic version and 1,023,167 (94.8 %) women had persistent breech presentation at the time of delivery. The rate of cesarean delivery was lower among women who had successful external cephalic version compared to those with persistent breech (20.2 % vs. 94.9 %; p external cephalic version were also less likely to experience several measures of significant maternal morbidity including endometritis (adjusted Odds Ratio (aOR) = 0.36, 95 % Confidence Interval (CI) 0.24-0.52), sepsis (aOR = 0.35, 95 % CI 0.24-0.51) and length of stay > 7 days (aOR = 0.53, 95 % CI 0.40-0.70), but had a higher risk of chorioamnionitis (aOR = 1.83, 95 % CI 1.54-2.17). Overall a low proportion of women with breech presentation undergo successful external cephalic version, and it is associated with significant reduction in the frequency of cesarean delivery and a number of measures of maternal morbidity. Increased external cephalic version use may be an important approach to mitigate the high rate of

  9. Predictors of successful outcomes after external cephalic version in singleton term breech pregnancies: a nine-year historical cohort study.

    Science.gov (United States)

    Cho, L Y; Lau, W L; Lo, T K; Tang, Helen H T; Leung, W C

    2012-02-01

    To study the success rate, predictors for success, and pregnancy outcomes after external cephalic version. Historical cohort study. Regional hospital, Hong Kong. All women who had singleton term breech pregnancies at term and opted for external cephalic version during 2001 and 2009. Their demographic data, clinical and ultrasound findings, procedure details, complications, and delivery outcomes were analysed. Predictive factors for successful external cephalic version. A total of 209 external cephalic versions were performed during the 9-year period. The success rate was 63% (75% for multiparous and 53% for nulliparous women). There was no significant complication. On univariate analysis, predictors of successful external cephalic version were: multiparity, unengaged presenting part, higher amniotic fluid index (≥ 10 cm), thin abdominal wall, low uterine tone, and easily palpable fetal head (subjective assessment by practitioners before external cephalic version). On multivariate analysis, only multiparity, non-engagement of the fetal buttock and thin maternal abdomen were associated with successful external cephalic version. In all, 69% of those who had successful external cephalic version succeeded in the first roll (Pexternal cephalic versions had vaginal deliveries (93% in multiparous and 69% in nulliparous women). Uptake rate of external cephalic version was studied in the latter part of the study period (2006-2009). Whilst 735 women were eligible for external cephalic version, 131 women chose to have the procedure resulting in an uptake rate of 18%. External cephalic version was effective in reducing breech presentations at term and corresponding caesarean section rates, but the uptake rate was low. Further work should address the barriers to the low acceptance of external cephalic version. The results of this study could encourage women to opt for external cephalic version.

  10. A randomized trial of remifentanil for analgesia in external cephalic version for breech presentation.

    Science.gov (United States)

    Liu, Xiaohua; Xue, Aiqin

    2016-12-01

    Although external cephalic version (ECV) can be effective for correcting the fetus in a cephalic presentation, it may be painful for the mother. This study aimed to evaluate the efficacy and safety of remifentanil for pain relief during ECV in China. In all, 152 Chinese parturients with singleton breech presentation were randomly divided into 2 groups, each with 76 patients. All 152 patients were assigned to receive either remifentanil (infused at 0.1 μg/kg/min and demand boluses of 0.1 μg/kg) or saline placebo. The study was performed between January 2012 and December 2015. Outcome measurements included the Numerical Rating Pain Scale score (0-10) after ECV, success rate for ECV, and maternal satisfaction after ECV. Adverse events were also evaluated. The study was completed by 146 patients. Remifentanil showed greater efficacy than placebo in decreasing the pain score immediately after ECV (remifentanil 4.6 ± 2.6 vs placebo 6.5 ± 2.7; P < 0.001). The success rate for ECV showed a significant difference between the 2 groups (remifentanil 56.5% vs placebo 39.5%; P = 0.04). Maternal satisfaction also showed a significant difference between the 2 groups (remifentanil 9.6 ± 1.4 vs placebo 6.4 ± 3.7; P < 0.001). However, the adverse events profiles were similar between both groups. The results of this study demonstrate that remifentanil is an effective intervention for reducing pain, achieving successful ECV, and increasing maternal satisfaction during ECV, and is generally well-tolerated without additional adverse effects.

  11. Randomized trial of anaesthetic interventions in external cephalic version for breech presentation.

    Science.gov (United States)

    Khaw, K S; Lee, S W Y; Ngan Kee, W D; Law, L W; Lau, T K; Ng, F F; Leung, T Y

    2015-06-01

    Successful external cephalic version (ECV) for breech presenting fetus reduces the need for Caesarean section (CS). We aimed to compare the success rate of ECV with either spinal anaesthesia (SA) or i.v. analgesia using remifentanil. In a double-phased, stratified randomized blinded controlled study we compared the success rates of ECV, performed under spinal anaesthesia (SA), i.v. analgesia (IVA) using remifentanil or no anaesthetic interventions. In phase I, 189 patients were stratified by parity before randomization to ECV, performed by blinded operators, under SA using either hyperbaric bupivacaine 9 mg with fentanyl 15 µg, i.v. remifentanil infusion 0.1 µg kg min(-1), or Control (no anaesthetic intervention). Operators performing ECV were blinded to the treatment allocation. In phase 2, patients in the Control group in whom the initial ECV failed were further randomized to receive either SA (n=9) or IVA (n=9) for a re-attempt. The primary outcome was the incidence of successful ECV. The success rate in Phase 1 was greatest using SA [52/63 (83%)], compared with IVA [40/63 (64%)] and Control [40/63 (64%)], (P=0.027). Median [IQR] pain scores on a visual analogue scale (range 0-100), were 0 [0-0] with SA, 35 [0-60] with IVA and 50 [30-75] in the Control group (P<0.001). Median [IQR] VAS sedation scores were highest with IVA [75 (50-80)], followed by SA, [0 (0-50)] and Control [0 (0-0)]. In phase 2, 7/9 (78%) of ECV re-attempts were successful with SA, whereas all re-attempts using IVA failed (P=0.0007). The incidence of fetal bradycardia necessitating emergency CS within 30 min, was similar among groups; 1.6% (1/63) in the SA and IVA groups and 3.2% (2/63) in the Control group. SA increased the success rate and reduced pain for both primary and re-attempts of ECV, whereas IVA using remifentanil infusion only reduced the pain. There was no significant increase in the incidence of fetal bradycardia or emergency CS, with ECV performed under anaesthetic

  12. Media Representations of Breech Birth: A Prospective Analysis of Web-Based News Reports.

    Science.gov (United States)

    Petrovska, Karolina; Sheehan, Athena; Homer, Caroline S E

    2017-07-01

    Recent research has demonstrated that the media presentation of childbirth is highly medicalized, often portraying birth as risky and dramatic. Media representation of breech presentation and birth is unexplored in this context. This study aimed to explore the content and tone of news media reports relating to breech presentation and breech birth. Google alerts were created using the terms breech and breech birth in online English-language news sites over a 3-year period from January 1, 2013, to December 31, 2015. Alerts were received daily and filed for analysis, and data were analyzed to generate themes. A total of 138 web-based news reports were gathered from 9 countries. Five themes that arose from the data included the problem of breech presentation, the high drama of vaginal breech birth, the safe option of cesarean birth versus dangers of vaginal breech birth, the defiant mother versus the saintly mother, and vaginal breech birth and medical misadventure. Media reports in this study predominantly demonstrated negative views toward breech presentation and vaginal breech birth. Cesarean birth was portrayed as the safe option for breech birth, while vaginal breech birth was associated with poor outcomes. Media presentations may impact decision making about mode of birth for pregnant women with a breech fetus. Health care providers can play an important role in balancing the media depiction of planned vaginal breech birth by providing nonjudgmental, evidence-based information to such women to facilitate informed decision making for birth. © 2017 by the American College of Nurse-Midwives.

  13. Persistent Breech Presentation in a Bicornuate Uterus: A Case Report

    African Journals Online (AJOL)

    We report a case of persistent breech presentation in a primigravida with bicornuate uterus that was initially diagnosed by early ultrasound scan. Persistent breech presentation later in the pregnancy necessitated an elective caesarean section at term. The diagnosis was confirmed intraoperatively by exteriorizing the uterus.

  14. Revisiting the mode of delivery and outcome of singleton breech ...

    African Journals Online (AJOL)

    There was an increased rate of special care baby unit admission in the group that had assisted vaginal breech delivery than in those that had elective caesarean section. There was no difference in terms of birth injury, neonatal death and maternal morbidities between those that had assisted vaginal breech delivery and ...

  15. Effect of Intrathecal Bupivacaine Dose on the Success of External Cephalic Version for Breech Presentation: A Prospective, Randomized, Blinded Clinical Trial.

    Science.gov (United States)

    Chalifoux, Laurie A; Bauchat, Jeanette R; Higgins, Nicole; Toledo, Paloma; Peralta, Feyce M; Farrer, Jason; Gerber, Susan E; McCarthy, Robert J; Sullivan, John T

    2017-10-01

    Breech presentation is a leading cause of cesarean delivery. The use of neuraxial anesthesia increases the success rate of external cephalic version procedures for breech presentation and reduces cesarean delivery rates for fetal malpresentation. Meta-analysis suggests that higher-dose neuraxial techniques increase external cephalic version success to a greater extent than lower-dose techniques, but no randomized study has evaluated the dose-response effect. We hypothesized that increasing the intrathecal bupivacaine dose would be associated with increased external cephalic version success. We conducted a randomized, double-blind trial to assess the effect of four intrathecal bupivacaine doses (2.5, 5.0, 7.5, 10.0 mg) combined with fentanyl 15 μg on the success rate of external cephalic version for breech presentation. Secondary outcomes included mode of delivery, indication for cesarean delivery, and length of stay. A total of 240 subjects were enrolled, and 239 received the intervention. External cephalic version was successful in 123 (51.5%) of 239 patients. Compared with bupivacaine 2.5 mg, the odds (99% CI) for a successful version were 1.0 (0.4 to 2.6), 1.0 (0.4 to 2.7), and 0.9 (0.4 to 2.4) for bupivacaine 5.0, 7.5, and 10.0 mg, respectively (P = 0.99). There were no differences in the cesarean delivery rate (P = 0.76) or indication for cesarean delivery (P = 0.82). Time to discharge was increased 60 min (16 to 116 min) with bupivacaine 7.5 mg or higher as compared with 2.5 mg (P = 0.004). A dose of intrathecal bupivacaine greater than 2.5 mg does not lead to an additional increase in external cephalic procedural success or a reduction in cesarean delivery.

  16. Turning breech babies after 34 weeks: the if, how, & when of turning breech babies.

    Science.gov (United States)

    Cohain, Judy Slome

    2007-01-01

    Techniques for turning a term breech baby are 1). External cephalic version (ECV) using hands and ultrasound only; 2). Acupuncture point stimulation, by needle or moxibustion; 3). Chiropractic "Webster" technique; 4). Hypnotherapy; and 5). Special exercises. Fifty % of breech fetuses at 34 weeks will turn by themselves to head down by 38 weeks. Therefore, to be considered effective, a technique for turning breech must turn the baby and keep it turned more than 50% of the time. Only ECV with an experienced practitioner has been documented to have a greater than 50% success rate at 37 weeks; in 95% of cases the head stays down. Most women experience the fetus turning by hand as quick but very painful. "Unstable lie" is sometimes used as a baseless excuse for inducing labor after the baby turns from breech to head down. (judyslome@hotmail.com).

  17. A randomized controlled trial of the effect of combined spinal-epidural analgesia on the success of external cephalic version for breech presentation.

    Science.gov (United States)

    Sullivan, J T; Grobman, W A; Bauchat, J R; Scavone, B M; Grouper, S; McCarthy, R J; Wong, C A

    2009-10-01

    Improving the success of external cephalic version (ECV) for breech presentation may help avoid some cesarean deliveries. The results of randomized trials comparing the success of ECV with neuraxial analgesia compared to control are inconsistent. We hypothesized that combined spinal-epidural (CSE) analgesia would increase the success of ECV when compared with systemic opioid analgesia. Parturients with singleton breech presentation (n=96) were randomized to receive CSE analgesia with bupivacaine 2.5mg and fentanyl 15 microg (CSE group) or intravenous fentanyl 50 microg (SYS group) before ECV attempt. The primary outcome was ECV success. The success rate of ECV was 47% with CSE and 31% in the SYS group (P=0.14). Subsequent vaginal delivery was 36% for CSE and 25% for SYS (P=0.27). Median [IQR] visual analog pain scores (0-100mm scale) were lower with CSE (3 [0-12]) compared to SYS analgesia (36 [16 to 54]) (P<0.005) and patient satisfaction (0-10 scale) was higher (CSE 10 [9 to 10] versus SYS 7 [4 to 9]) (P<0.005). There were no differences in fetal heart rate patterns, but median time to return to fetal heart rate reactivity after analgesia was shorter with CSE (13 [IQR 9-21] min) compared to the SYS group (39 [IQR 23-51] min) (P=0.02). There was no difference in the rate of successful ECV or vaginal delivery with CSE compared to intravenous fentanyl analgesia. Pain scores were lower and satisfaction higher with CSE analgesia, and median time to fetal heart rate reactivity was shorter in the CSE group.

  18. Is routine caesarean section necessary for breech-breech and ...

    African Journals Online (AJOL)

    Subjects: Twin gestations with breech-breech and breech-transverse presentations. Main outcome measures: Birth weights, 5-minute Apgar scores and neonatal mortality rates among 41 women who underwent vaginal delivery were compared with those of 27 who underwent transverse lower-segment caesarean sections.

  19. The Early External Cephalic Version (ECV) 2 Trial: an international multicentre randomised controlled trial of timing of ECV for breech pregnancies.

    Science.gov (United States)

    Hutton, E K; Hannah, M E; Ross, S J; Delisle, M-F; Carson, G D; Windrim, R; Ohlsson, A; Willan, A R; Gafni, A; Sylvestre, G; Natale, R; Barrett, Y; Pollard, J K; Dunn, M S; Turtle, P

    2011-04-01

    To investigate whether initiating external cephalic version (ECV) earlier in pregnancy might increase the rate of successful ECV procedures, and be more effective in decreasing the rate of non-cephalic presentation at birth and of caesarean section. An unblinded multicentred randomised controlled trial. A total of 1543 women were randomised from 68 centres in 21 countries. Women with a singleton breech fetus at a gestational age of 33(0/7) weeks (231 days) to 35(6/7) weeks (251 days) of gestation were included. Participants were randomly assigned to having a first ECV procedure between the gestational ages of 34(0/7) (238 days) and 35(6/7) weeks of gestation (early ECV group) or at or after 37(0/7) (259 days) weeks of gestation (delayed ECV group). The primary outcome was the rate of caesarean section; the secondary outcome was the rate of preterm birth. Fewer fetuses were in a non-cephalic presentation at birth in the early ECV group (314/765 [41.1%] versus 377/768 [49.1%] in the delayed ECV group; relative risk [RR] 0.84, 95% CI 0.75, 0.94, P=0.002). There were no differences in rates of caesarean section (398/765 [52.0%] versus 430/768 [56.0%]; RR 0.93, 95% CI 0.85, 1.02, P=0.12) or in risk of preterm birth (50/765 [6.5%] versus 34/768 [4.4%]; RR 1.48, 95% CI 0.97, 2.26, P=0.07) between groups. External cephalic version at 34-35 weeks versus 37 or more weeks of gestation increases the likelihood of cephalic presentation at birth but does not reduce the rate of caesarean section and may increase the rate of preterm birth. © 2011 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2011 RCOG.

  20. [Umbilical blood-gas status at cesarean section for breech presentation: a comparison with vertex presentation].

    Science.gov (United States)

    Haruta, M; Saeki, N; Naka, Y; Funato, T; Ohtsuki, Y

    1989-10-01

    Umbilical blood-gas status at elective cesarean section with oxygen inhalation for breech presentation (25 cases) was compared with that for vertex presentation (25 cases), so as to confirm the security of full-term breech fetuses delivered by cesarean section under spinal anesthesia. Umbilical arterial oxygen levels were significantly lower in the breech group (Mean PO2:18.9 mmHg; SO2:37.3%; Oxygen content:7.6 ml/dl). The number of hypoxemic fetuses was significantly higher in the breech group (the breech: 7; the vertex; 0). The other umbilical blood-gas values revealed no significant differences between the breech and vertex groups, and were within normal limits in both groups. Oxygen extraction in the breech (Mean: 49.0%) was higher than that in the vertex (32.9%). Therefore decreased umbilical blood flow in the breech was suggested. The incidence of depression at 1 minute after delivery in the breech infants (24%) was significantly higher than that in the vertex infants (0%). It became obvious in the breech that as the interval between the uterine incision and delivery increased, umbilical arterial blood tended to acidosis and the 1 minute Apgar score decreased. Cesarean section for breech presentation requires sufficient and optimal incisions of the abdominal wall and uterus as well as a skillful manual delivery technique, because the fetus or neonate should be protected against asphyxia resulting from umbilical compression and prolonged delivery interval.

  1. Objective Structured Assessment of Technical Skills (OSATS) evaluation of theoretical versus hands-on training of vaginal breech delivery management: a randomized trial.

    Science.gov (United States)

    Buerkle, Bernd; Rueter, Katharina; Hefler, Lukas A; Tempfer-Bentz, Eva-Katrin; Tempfer, Clemens B

    2013-12-01

    To compare the skills of performing a vaginal breech (VB) delivery after hands-on training versus demonstration. We randomized medical students to a 30-min demonstration (group 1) or a 30-min hands-on (group 2) training session using a standardized VB management algorithm on a pelvic training model. Subjects were tested with a 25 item Objective Structured Assessment of Technical Skills (OSATS) scoring system immediately after training and 72 h thereafter. OSATS scores were the primary outcome. Performance time (PT), self assessment (SA), confidence (CON), and global rating scale (GRS) were the secondary outcomes. Statistics were performed using the Mann-Whitney U-test, chi-square test, and multiple linear regression analysis. 172 subjects were randomized. OSATS scores (primary outcome) were significantly higher in group 2 (n=88) compared to group 1 (n=84) (21.18±2.29 vs. 20.19±2.37, respectively; p=0.006). The secondary outcomes GRS (10.31±2.28 vs. 9.17±2.21; p=0.001), PT (214.60±57.97 s vs. 246.98±59.34 s; ptraining leads to a significant improvement of VB management in a pelvic training model, but this effect was only seen in the short term. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  2. Facilitators and barriers to external cephalic version for breech presentation at term among health care providers in the Netherlands: a quantitative analysis.

    Science.gov (United States)

    Rosman, Ageeth N; Vlemmix, Floortje; Beuckens, Antje; Rijnders, Marlies E; Opmeer, Brent C; Mol, Ben Willem J; Kok, Marjolein; Fleuren, Margot A H

    2014-03-01

    guidelines recommend that external cephalic version (ECV) should be offered to all women with a fetus in breech presentation at term. However, only 50-60% of the women receive an ECV attempt. We explored the determinants (barriers and facilitators) affecting the uptake of the guidelines among gynaecologists and midwives in the Netherlands. national online survey. the Netherlands. gynaecologists and midwives. in the online survey, we identified the determinants that positively or negatively influenced the professionals׳ adherence to three key recommendations in the guidelines: (a) counselling, (b) advising for ECV, (c) arranging an ECV. Determinants were identified in a previously performed qualitative study and were categorised into five underlying constructs; attitude towards ECV, professional obligation, outcome expectations, self-efficacy and preconditions for successful ECV. We performed a multivariate analysis to assess the importance of the different constructs for adherence to the guideline. 364 professionals responded to the survey. Adherence varied: 84% counselled, 73% advised, and 82% arranged an ECV for (almost) all their clients. Although 90% of respondents considered ECV to be an effective treatment for preventing caesarean childbirths, only 30% agreed that 'every client should undergo ECV'. Self-efficacy (perceived skills) was the most important determinant influencing adherence. self-efficacy appears to be the most significant determinant for counselling, advising and arranging an ECV. to improve adherence to the guidelines on ECV we must improve self-efficacy. Copyright © 2014. Published by Elsevier Ltd.

  3. Implementation of the external cephalic version in breech delivery. Dutch national implementation study of external cephalic version

    Directory of Open Access Journals (Sweden)

    Papatsonis Dimitri N

    2010-05-01

    Full Text Available Abstract Background Breech presentation occurs in 3 to 4% of all term pregnancies. External cephalic version (ECV is proven effective to prevent vaginal breech deliveries and therefore it is recommended by clinical guidelines of the Royal Dutch Organisation for Midwives (KNOV and the Dutch Society for Obstetrics and Gynaecology (NVOG. Implementation of ECV does not exceed 50 to 60% and probably less. We aim to improve the implementation of ECV to decrease maternal and neonatal morbidity and mortality due to breech presentations. This will be done by defining barriers and facilitators of implementation of ECV in the Netherlands. An innovative implementation strategy will be developed based on improved patient counselling and thorough instructions of health care providers for counselling. Method/design The ultimate purpose of this implementation study is to improve counselling of pregnant women and information of clinicians to realize a better implementation of ECV. The first phase of the project is to detect the barriers and facilitators of ECV. The next step is to develop an implementation strategy to inform and counsel pregnant women with a breech presentation, and to inform and educate care providers. In the third phase, the effectiveness of the developed implementation strategy will be evaluated in a randomised trial. The study population is a random selection of midwives and gynaecologists from 60 to 100 hospitals and practices. Primary endpoints are number of counselled women. Secondary endpoints are process indicators, the amount of fetes in cephalic presentation at birth, complications due to ECV, the number of caesarean sections and perinatal condition of mother and child. Cost effectiveness of the implementation strategy will be measured. Discussion This study will provide evidence for the cost effectiveness of a structural implementation of external cephalic versions to reduce the number of breech presentations at term. Trial

  4. Implementation of the external cephalic version in breech delivery. Dutch national implementation study of external cephalic version.

    Science.gov (United States)

    Vlemmix, Floortje; Rosman, Ageeth N; Fleuren, Margot A H; Rijnders, Marlies E B; Beuckens, Antje; Haak, Monique C; Akerboom, Bettina M C; Bais, Joke M J; Kuppens, Simone M I; Papatsonis, Dimitri N; Opmeer, Brent C; van der Post, Joris A M; Mol, Ben Willem J; Kok, Marjolein

    2010-05-10

    Breech presentation occurs in 3 to 4% of all term pregnancies. External cephalic version (ECV) is proven effective to prevent vaginal breech deliveries and therefore it is recommended by clinical guidelines of the Royal Dutch Organisation for Midwives (KNOV) and the Dutch Society for Obstetrics and Gynaecology (NVOG). Implementation of ECV does not exceed 50 to 60% and probably less.We aim to improve the implementation of ECV to decrease maternal and neonatal morbidity and mortality due to breech presentations. This will be done by defining barriers and facilitators of implementation of ECV in the Netherlands. An innovative implementation strategy will be developed based on improved patient counselling and thorough instructions of health care providers for counselling. The ultimate purpose of this implementation study is to improve counselling of pregnant women and information of clinicians to realize a better implementation of ECV.The first phase of the project is to detect the barriers and facilitators of ECV. The next step is to develop an implementation strategy to inform and counsel pregnant women with a breech presentation, and to inform and educate care providers. In the third phase, the effectiveness of the developed implementation strategy will be evaluated in a randomised trial. The study population is a random selection of midwives and gynaecologists from 60 to 100 hospitals and practices. Primary endpoints are number of counselled women. Secondary endpoints are process indicators, the amount of fetes in cephalic presentation at birth, complications due to ECV, the number of caesarean sections and perinatal condition of mother and child. Cost effectiveness of the implementation strategy will be measured. This study will provide evidence for the cost effectiveness of a structural implementation of external cephalic versions to reduce the number of breech presentations at term. Dutch Trial Register (NTR): 1878.

  5. Cephalic version by moxibustion for breech presentation.

    Science.gov (United States)

    Coyle, Meaghan E; Smith, Caroline A; Peat, Brian

    2012-05-16

    Moxibustion (a type of Chinese medicine which involves burning a herb close to the skin) to the acupuncture point Bladder 67 (BL67) (Chinese name Zhiyin), located at the tip of the fifth toe, has been proposed as a way of correcting breech presentation. To examine the effectiveness and safety of moxibustion on changing the presentation of an unborn baby in the breech position, the need for external cephalic version (ECV), mode of birth, and perinatal morbidity and mortality for breech presentation. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (26 March 2012), MEDLINE (1966 to 1 August 2011), EMBASE (1980 to August 2011), CINAHL (1982 to 1 August 2011), MIDIRS (1982 to 1 August 2011) and AMED (1985 to 1 August 2011) and searched bibliographies of relevant papers. The inclusion criteria were published and unpublished randomised controlled trials comparing moxibustion (either alone or in combination with acupuncture or postural techniques) with a control group (no moxibustion), or other methods (e.g. external cephalic version, acupuncture, postural techniques) in women with a singleton breech presentation. Two review authors independently assessed eligibility and trial quality and extracted data. The outcome measures were baby's presentation at birth, need for external cephalic version, mode of birth, perinatal morbidity and mortality, maternal complications and maternal satisfaction, and adverse events. Six new trials have been added to this updated review. One trial has been moved to studies awaiting classification while further data are being requested. This updated review now includes a total of eight trials (involving 1346 women). Meta-analyses were undertaken (where possible) for the main and secondary outcomes. Moxibustion was not found to reduce the number of non-cephalic presentations at birth compared with no treatment (P = 0.45). Moxibustion resulted in decreased use of oxytocin before or during labour for women who had vaginal

  6. Improving external cephalic version for foetal breech presentation.

    Science.gov (United States)

    Zandstra, H; Mertens, H J M M

    2013-01-01

    If success rate of external cephalic version (ECV) increases, the rate of primary caesarean sections -declines. The aims of this retrospective cohort study were to evaluate the ECV and to identify factors associated with the success rate of ECV for breech presentation at term. The second aim of this study was to analyse the outcome of labour of all patients with a foetus in breech near term. All women with a foetus in breech near or at term were included. Logistic regression analyses were -performed to identify the association between patient characteristics and success rate of ECV. The overall rate of successful ECV's was 19%. Foetal and maternal complications after ECV were negligible. BMI, type of breech and amount of amniotic fluid were significantly correlated with a successful ECV. The rate of primary caesarean sections for the group of patients who underwent an ECV was lower than the rate in the group who did not (52.9% vs. 79.6%). The rate of spontaneous deliveries was increased after ECV (36% versus 12%). After successful ECV the rate of spontaneous deliveries was 75%; after unsuccessful ECV 26.8%. The overall rate of successful ECV was low (19%). BMI, type of breech and amount of amniotic fluid were significantly correlated with a successful ECV. The rate of primary caesarean sections was significantly lower in patients with ECV (52.9% versus 79.6%). The rate of spontaneous deliveries was significantly higher (36% -versus 12%).

  7. Cephalic version by postural management for breech presentation.

    Science.gov (United States)

    Hofmeyr, G Justus; Kulier, Regina

    2012-10-17

    Babies with breech presentation (bottom first) are at increased risk of complications during birth, and are often delivered by caesarean section. The chance of breech presentation persisting at the time of delivery, and the risk of caesarean section, can be reduced by external cephalic version (ECV - turning the baby by manual manipulation through the mother's abdomen). It is also possible that maternal posture may influence fetal position. Many postural techniques have been used to promote cephalic version. The objective of this review was to assess the effects of postural management of breech presentation on measures of pregnancy outcome. We evaluated procedures in which the mother rests with her pelvis elevated. These include the knee-chest position, and a supine position with the pelvis elevated with a wedge-shaped cushion. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (22 August 2012). Randomised and quasi-randomised trials comparing postural management with pelvic elevation for breech presentation, with a control group. One or both review authors assessed eligibility and trial quality. We have included six studies involving a total of 417 women. The rates for non-cephalic births, Cesarean section and Apgar scores below 7 at one minute, regardless of whether ECV was attempted or not, were similar between the intervention and control groups (risk ratio (RR) 0.98; 95% confidence interval (CI) 0.84 to 1.15; RR 1.10; 95% CI 0.89 to 1.37; RR 0.88; 95% CI 0.50 to 1.55). There is insufficient evidence from well-controlled trials to support the use of postural management for breech presentation. The numbers of women studied to date remain relatively small. Further research is needed.

  8. Protocol for the evaluation of a decision aid for women with a breech-presenting baby [ISRCTN14570598

    Directory of Open Access Journals (Sweden)

    Peat Brian

    2004-12-01

    Full Text Available Abstract Background There is now good evidence about the management options for pregnant women with a breech presentation (buttocks or feet rather than head-first at term; external cephalic version (ECV – the turning of a breech baby to a head-down position and/or planned caesarean section (CS. Each of these options has benefits and risks and the relative importance of these vary for each woman, subject to her personal values and preferences, a situation where a decision aid may be helpful. Decision aids are designed to assist patients and their doctors in making informed decisions using information that is unbiased and based on high quality research evidence. Decision aids are non-directive in the sense that they do not aim to steer the user towards any one option, but rather to support decision making which is informed and consistent with personal values. The ECV decision aid was developed using the Ottawa Decision Support Framework, including a systematic review of the evidence about the benefits and risks of the options for breech pregnancy. It comprises an audiotape with a supplementary booklet and worksheet, a format that can be taken home and discussed with a partner. This project aims to evaluate the ECV decision aid for women with a breech presenting baby in late pregnancy. Study design We aim to evaluate the effectiveness of the decision aid compared with usual care in a randomised controlled trial in maternity hospitals that offer ECV. The study group will receive the decision aid in addition to usual care and the control group will receive standard information on management options for breech presentation from their usual pregnancy care provider. Approximately 184 women with a single breech-presenting baby at greater than 34 weeks gestation and who are clinically eligible for ECV will be recruited for the trial. The primary outcomes of the study are knowledge, decisional conflict, anxiety and satisfaction with decision-making that

  9. Protocol for the evaluation of a decision aid for women with a breech-presenting baby [ISRCTN14570598

    Science.gov (United States)

    Roberts, Christine L; Nassar, Natasha; Barratt, Alexandra; Raynes-Greenow, Camille H; Peat, Brian; Henderson-Smart, David

    2004-01-01

    Background There is now good evidence about the management options for pregnant women with a breech presentation (buttocks or feet rather than head-first) at term; external cephalic version (ECV) – the turning of a breech baby to a head-down position and/or planned caesarean section (CS). Each of these options has benefits and risks and the relative importance of these vary for each woman, subject to her personal values and preferences, a situation where a decision aid may be helpful. Decision aids are designed to assist patients and their doctors in making informed decisions using information that is unbiased and based on high quality research evidence. Decision aids are non-directive in the sense that they do not aim to steer the user towards any one option, but rather to support decision making which is informed and consistent with personal values. The ECV decision aid was developed using the Ottawa Decision Support Framework, including a systematic review of the evidence about the benefits and risks of the options for breech pregnancy. It comprises an audiotape with a supplementary booklet and worksheet, a format that can be taken home and discussed with a partner. This project aims to evaluate the ECV decision aid for women with a breech presenting baby in late pregnancy. Study design We aim to evaluate the effectiveness of the decision aid compared with usual care in a randomised controlled trial in maternity hospitals that offer ECV. The study group will receive the decision aid in addition to usual care and the control group will receive standard information on management options for breech presentation from their usual pregnancy care provider. Approximately 184 women with a single breech-presenting baby at greater than 34 weeks gestation and who are clinically eligible for ECV will be recruited for the trial. The primary outcomes of the study are knowledge, decisional conflict, anxiety and satisfaction with decision-making that will be assessed using

  10. The fact and the fiction: A prospective study of internet forum discussions on vaginal breech birth.

    Science.gov (United States)

    Petrovska, Karolina; Sheehan, Athena; Homer, Caroline S E

    2017-04-01

    Women with a breech baby late in pregnancy may use the internet to gather information to assist in decision-making for birth. The aim of this study was to examine how women use English language internet discussion forums to find out information about vaginal breech birth and to increase understanding of how vaginal breech birth is perceived among women. A descriptive qualitative study of internet discussion forums was undertaken. Google alerts were created with the search terms "breech birth" and "breech". Alerts were collected for a one-year period (January 2013-December 2013). The content of forum discussions was analysed using thematic analysis. A total of 50 forum discussions containing 382 comments were collected. Themes that arose from the data were: Testing the waters-which way should I go?; Losing hope for the chance of a normal birth; Seeking support for options-who will listen to me?; Considering vaginal breech birth-a risky choice?; Staying on the 'safe side'-caesarean section as a guarantee; Exploring the positive potential for vaginal breech birth. Women search online for information about vaginal breech birth in an attempt to come to a place in their decision-making where they feel comfortable with their birth plan. This study highlights the need for clinicians to provide comprehensive, unbiased information on the risks and benefits of all options for breech birth to facilitate informed decision-making for the woman. This will contribute to improving the woman's confidence in distinguishing between "the fact and the fiction" of breech birth discussions online. Copyright © 2016 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.

  11. Finding the breech: Influence of breech presentation on mode of delivery based on timing of diagnosis, attempt at external cephalic version, and provider success with version.

    Science.gov (United States)

    Andrews, Suzanne; Leeman, Lawrence; Yonke, Nicole

    2017-09-01

    Breech presentation affects 3-4% of pregnancies at term and malpresentation is the primary indication for 10-15% of cesarean deliveries. External cephalic version is an effective intervention that can decrease the need for cesarean delivery; however, timely identification of breech presentation is required. We hypothesized that women with a fetus in a breech presentation that is diagnosed after 38 weeks' estimated gestational age have a decreased likelihood of external cephalic version attempted and an increased likelihood of cesarean delivery. This was a retrospective cohort study. A chart review was performed for 251 women with breech presentation at term presenting to our tertiary referral university hospital for external cephalic version, cesarean for breech presentation, or vaginal breech delivery. Vaginal delivery was significantly more likely (31.1% vs 12.5%; Pexternal cephalic version was offered, and subsequently attempted in a greater proportion of women diagnosed before 38 weeks. External cephalic version was more successful when performed by physicians with greater procedural volume during the 3.5 year period of the study (59.1% for providers performing at least 10 procedures vs 31.3% if performing fewer than 10 procedures, Pexternal cephalic version. © 2017 Wiley Periodicals, Inc.

  12. Risk of developmental dysplasia of the hip in breech presentation: the effect of successful external cephalic version

    NARCIS (Netherlands)

    Lambeek, A. F.; de Hundt, M.; Vlemmix, F.; Akerboom, B. M. C.; Bais, J. M. J.; Papatsonis, D. N. M.; Mol, B. W. J.; Kok, M. [=Marjolein

    2013-01-01

    To evaluate the effect of successful external cephalic version on the incidence of developmental dysplasia of the hip (DDH) requiring treatment in singleton breech presentation at term. Observational cohort study. Three large teaching hospitals in the Netherlands. Women with a singleton breech

  13. Implementation of the external cephalic version in breech delivery. Dutch national implementation study of external cephalic version

    NARCIS (Netherlands)

    Vlemmix, F.; Rosman, A N; Fleuren, M A H; Rijnders, M E B; Beuckens, A.; Haak, M.C.; Akerboom, B.M.C.; Bais, J.M.J.; Kuppens, S M I; Papatsonis, D.N.M.; Opmeer, Brent C; van der Post, J.A.M.; Mol, B.W.J.; Kok, M

    2010-01-01

    Background: Breech presentation occurs in 3 to 4% of all term pregnancies. External cephalic version (ECV) is proven effective to prevent vaginal breech deliveries and therefore it is recommended by clinical guidelines of the Royal Dutch Organisation for Midwives (KNOV) and the Dutch Society for

  14. Implementation of the external cephalic version in breech delivery Dutch national implementation study of external cephalic version

    NARCIS (Netherlands)

    Vlemmix, Floortje; Rosman, Ageeth N.; Fleuren, Margot A. H.; Rijnders, Marlies E. B.; Beuckens, Antje; Haak, Monique C.; Akerboom, Bettina M. C.; Bais, Joke M. J.; Kuppens, Simone M. I.; Papatsonis, Dimitri N.; Opmeer, Brent C.; van der Post, Joris A. M.; Mol, Ben Willem J.; Kok, Marjolein

    2010-01-01

    ABSTRACT: BACKGROUND: Breech presentation occurs in 3 to 4 % of all term pregnancies. External cephalic version (ECV) is proven effective to prevent vaginal breech deliveries and therefore it is recommended by clinical guidelines of the Royal Dutch Organisation for Midwives (KNOV) and the Dutch

  15. Breech delivery at a University Hospital in Tanzania

    DEFF Research Database (Denmark)

    Högberg, Ulf; Claeson, Catrin; Krebs, Lone

    2016-01-01

    delivery (VD) (adjusted odds ratio (aOR) 6.2; 95 % confidence interval (CI) 3.0-12.6) and referral (aOR 2.1; 95 % CI 1.1-3.9), but not with parity, birth weight, or delivery year. Overall perinatal mortality was 5.8 % and this did not decline, due to an increase in stillbirths among vaginal breech......Background: There is a global increase in rates of Cesarean delivery (CD). A minor factor in this increase is a shift towards CD for breech presentation. The aim of this study was to analyze breech births by mode of delivery and investigate short-term fetal and maternal outcomes in a low...... death (stillbirths + in-hospital neonatal deaths) and moderate asphyxia. Maternal outcomes, such as death, hemorrhage, and length of hospital stay, were also described. Results: The CD rate for breech presentation increased from 28 % in 1999 to 78 % in 2010. Perinatal deaths were associated with vaginal...

  16. The Impact of an ECV Service is Limited by Antenatal Breech Detection: A Retrospective Cohort Study.

    Science.gov (United States)

    Hemelaar, Joris; Lim, Lee N; Impey, Lawrence W

    2015-06-01

    External cephalic version (ECV) reduces the chance of breech presentation at term birth and lowers the chance of a cesarean delivery. ECV services are now in place in many units in the United Kingdom but their effectiveness is unknown. The aim of this study was to investigate the reasons for breech presentation at term birth. We performed a retrospective cohort study of 394 consecutive babies who were in breech presentation at term birth in a large United Kingdom maternity unit that offers ECV. The cohort was analyzed over two time periods 10 years apart: 1998-1999 and 2008-2009. Only 33.8 percent of women had undergone a (failed) ECV attempt. This low proportion was mainly because breech presentation was not diagnosed antenatally (27.9%). Other contributing factors were: ECV not offered by clinicians (12.2%), ECV declined by women (14%), and contraindications to ECV (10.7%). Over the 10-year period, the proportion of breech presentations that were not diagnosed antenatally increased from 23.2 to 32.5 percent (p = 0.04), which constituted 52.8 percent of women who had not undergone an ECV attempt in 2008-2009. Failure of clinicians to offer ECV reduced from 21.6 to 3.0 percent (p = 0.0001) and the proportion of women declining ECV decreased from 19.1 to 9.0 percent (p = 0.005). Overall, ECV attempts increased from 28.9 to 38.5 percent (p = 0.05). Although ECV counseling, referral, and attempt rates have increased, failure to detect breech presentation antenatally is the principal barrier to successful ECV. Improved breech detection would have a greater impact than methods to increase ECV success rates. © 2015 Wiley Periodicals, Inc.

  17. Moxibustion for Cephalic Version of Breech Presentation.

    Science.gov (United States)

    Schlaeger, Judith M; Stoffel, Cynthia L; Bussell, Jeanie L; Cai, Hui Yan; Takayama, Miho; Yajima, Hiroyoshi; Takakura, Nobuari

    2018-05-01

    Moxibustion, a form of traditional Chinese medicine (TCM), is the burning of the herb moxa (Folium Artemisiae argyi or mugwort) over acupuncture points. It is often used in China to facilitate cephalic version of breech presentation. This article reviews the history, philosophy, therapeutic use, possible mechanisms of action, and literature pertaining to its use for this indication. For moxibustion, moxa can be rolled into stick form, placed directly on the skin, or placed on an acupuncture needle and ignited to warm acupuncture points. Studies have demonstrated that moxibustion may promote cephalic version of breech presentation and may facilitate external cephalic version. However, there is currently a paucity of research on the effects of moxibustion on cephalic version of breech presentation, and thus there is a need for further studies. Areas needing more investigation include efficacy, safety, optimal technique, and best protocol for cephalic version of breech presentation. © 2018 by the American College of Nurse-Midwives.

  18. [Fewer breech deliveries after implementation of a modified cephalic version protocol].

    Science.gov (United States)

    Kuppens, Simone M I; Francois, Anne M H; Hasaart, Tom H M; van der Donk, Maria W P; Pop, Victor J M

    2010-01-01

    To investigate the effect of implementation of a number of process policy guidelines (protocol), on the success rate of external cephalic version (ECV) for breech presentation. Prospective study. During a 3-year period (2004-2006) a standardized protocol for an ECV consultation was developed, evaluated and adapted. After implementing this modified protocol as 'process policy guidelines', the effect on the rate of successful ECV was prospectively evaluated during the period 1 January 2007-31 July 2008. Success was defined as cephalic presentation (ultrasound) immediately after ECV. A secondary outcome measure was the elective caesarean section rate for breech presentation. The rate of successful ECV increased significantly from 47% (110/236 pregnant women) in the period January 2004-December 2006 to 61% (85/139, p = 0.006) in the period January 2007-July 2008. Patient characteristics were similar in both groups, with the exception of 2 subgroups of term of version. The increase was preferentially found in nulliparous and multiparous women with frank breech. Nulliparity, frank breech, anterior placenta and low birth weight were associated with a lower success rate of ECV. The term of pregnancy at which ECV was performed did not seem to affect the success rate. Implementing the process policy guidelines increased the number of cephalic presentations at delivery and decreased the rate of elective caesarean sections for breech presentation from 39% to 27% (p = 0.03). The number needed to treat to prevent 1 elective caesarean section by ECV according to the process policy guidelines was 8. After implementation of the process policy guidelines, the success rate of ECV increased considerably. The rate of elective caesarean section for breech presentation declined. These findings are in favour of establishing specialized ECV centres in the Netherlands.

  19. A study of labour outcome in breech delivery

    Directory of Open Access Journals (Sweden)

    Suman Budania

    2017-01-01

    Full Text Available Aim: Breech is the most common form of malpresentation. It is defined as when foetus occupies a longitudinal lie with the pelvic extremity at the pelvic brim and head at the fundus of the uterus. The present study was conducted on 100 cases of breech presentation to find out the labour outcome in breech deliveries and various factors affecting it. Materials and Methods: The present study was conducted in the Department of Obstetrics and Gynaecology, Umaid Hospital, attached to Dr. S.N. Medical College, Jodhpur. A total of 100 cases of breech presentation including single as well as plural pregnancies in which one or more foetuses were presenting as breech were taken. Both booked and unbooked cases in primigravidae and multigravidae were studied. The cases were selected at random among those who got admitted in labour room. Results: In the present series, incidence of breech deliveries came to be 4.1094%. Incidence of breech presentation was maximum (45% in the age group of 21–25 years. In this study, out of 100 cases, 62 were multigravidae and 38 were primigravidae, and 43 cases (43% were associated with factors which endanger of life of the foetus, among which twin pregnancy and pre-eclamptic toxaemia were the most commonly associated factors. In the present series, among 100 cases studied, 14 were breech babies and congenital malformation, of which hydrocephalus was the most common malformation found. Conclusion: The study concludes that prematurity is associated with high incidence of breech presentation. The most common variety of breech presentation is flexed breech, which is found more in multigravidae. Caesarean section is the mode of delivery of choice as it carries minimal foetal loss. Extended variety of breech is safest for the baby and carries minimal foetal loss.

  20. [External cephalic version of breech fetus after 36 weeks of gestation - evaluation of efectiveness and complications].

    Science.gov (United States)

    Hruban, L; Janků, P; Jordánová, K; Gerychová, R; Huser, M; Ventruba, P; Roztočil, A

    2017-01-01

    Evaluation of success rate and the safety of external cephalic version after 36 weeks of gestation. Retrospective analysis. Department of Obstetrics and Gynecology, Masaryk University, University Hospital Brno. A retrospective analysis of external cephalic version attempts performed on a group of 638 singleton breech pregnancies after 36 weeks gestation in the years 2003-2016 at the Department of Gynecology and Obstetrics, Masaryk University, Brno. The effectiveness, number and type of complications, mode of delivery and perinatal result were observed. The effectiveness of external cephalic version from breech to head presentation was 47.8% (305 cases). After a successful external cephalic version 238 patients (78.0%) gave birth vaginally. After unsuccessful cephalic version 130 patients (39.0%) gave birth vaginally. The number of serious complications did not exceed 0,9% and did not affect perinatal outcomes. External cephalic version-related emergency cesarean deliveries occurred in 6 cases (2 placental abruption, 4 abnormal cardiotocography). The fetal outcome was good in all these cases. The death of the fetus in connection with the external version has not occurred in our file. Spontaneous discharge of amniotic fluid within 24 hours after procedure occurred in 5 cases (0.8%). The spontaneous onset of labor within 24 hours of procedure occurred in 5 cases (0.8%). The pH value of a. umbilicalis external version and in the group with unsuccessful external version in 9 cases. The Apgar score in the 5th minute external cephalic version of the fetus in the case of breech presentation after the 36th week of pregnancy is an effective and safe alternative for women who have a fear of the vaginal breech delivery. Performing the external cephalic version can reduce the rate of elective caesarean sections due to breech presentation at term.

  1. Cost-effectiveness of breech version by acupuncture-type interventions on BL 67, including moxibustion, for women with a breech foetus at 33 weeks gestation: a modelling approach.

    Science.gov (United States)

    van den Berg, Ineke; Kaandorp, Guido C; Bosch, Johanna L; Duvekot, Johannes J; Arends, Lidia R; Hunink, M G Myriam

    2010-04-01

    To assess, using a modelling approach, the effectiveness and costs of breech version with acupuncture-type interventions on BL67 (BVA-T), including moxibustion, compared to expectant management for women with a foetal breech presentation at 33 weeks gestation. A decision tree was developed to predict the number of caesarean sections prevented by BVA-T compared to expectant management to rectify breech presentation. The model accounted for external cephalic versions (ECV), treatment compliance, and costs for 10,000 simulated breech presentations at 33 weeks gestational age. Event rates were taken from Dutch population data and the international literature, and the relative effectiveness of BVA-T was based on a specific meta-analysis. Sensitivity analyses were conducted to evaluate the robustness of the results. We calculated percentages of breech presentations at term, caesarean sections, and costs from the third-party payer perspective. Odds ratios (OR) and cost differences of BVA-T versus expectant management were calculated. (Probabilistic) sensitivity analysis and expected value of perfect information analysis were performed. The simulated outcomes demonstrated 32% breech presentations after BVA-T versus 53% with expectant management (OR 0.61, 95% CI 0.43, 0.83). The percentage caesarean section was 37% after BVA-T versus 50% with expectant management (OR 0.73, 95% CI 0.59, 0.88). The mean cost-savings per woman was euro 451 (95% CI euro 109, euro 775; p=0.005) using moxibustion. Sensitivity analysis showed that if 16% or more of women offered moxibustion complied, it was more effective and less costly than expectant management. To prevent one caesarean section, 7 women had to use BVA-T. The expected value of perfect information from further research was euro0.32 per woman. The results suggest that offering BVA-T to women with a breech foetus at 33 weeks gestation reduces the number of breech presentations at term, thus reducing the number of caesarean sections

  2. [External cephalic version in cases of breech presentation: renaissance of a well-known procedure?].

    Science.gov (United States)

    Schmidt, M; Callies, R; Kuhn, U; Willruth, A; Kimmig, R

    2009-01-01

    About 3-4% of all pregnant women will have a fetus presenting by the breech at term. External cephalic version offers the opportunity to reduce the rate of caesarean sections caused by breech presentation. We analysed retrospectively 51 cases of external cephalic version at our clinic. External cephalic version was performed 51 times between 37 and 41 weeks of pregnancy. External cephalic version was successful in 32/51 cases (62,7%) with a consecutive rate of vaginal delivery of 71,9%. The best results were seen at 37 weeks of pregnancy with 81,25% of successful versions followed by 76,9% of vaginal deliveries. Complications were rare. There was just 1 case of emergency caesarean section due to persisting fetal bradycardia. External cephalic version is an effective and safe treatment to enable vaginal delivery of cephalic presentation. For this operation, 37 weeks of pregnancy can be considered the best time. 2009 S. Karger AG, Basel.

  3. Brief report: a cost analysis of neuraxial anesthesia to facilitate external cephalic version for breech fetal presentation.

    Science.gov (United States)

    Carvalho, Brendan; Tan, Jonathan M; Macario, Alex; El-Sayed, Yasser Y; Sultan, Pervez

    2013-07-01

    In this study, we sought to determine whether neuraxial anesthesia to facilitate external cephalic version (ECV) increased delivery costs for breech fetal presentation. Using a computer cost model, which considers possible outcomes and probability uncertainties at the same time, we estimated total expected delivery costs for breech presentation managed by a trial of ECV with and without neuraxial anesthesia. From published studies, the average probability of successful ECV with neuraxial anesthesia was 60% (with individual studies ranging from 44% to 87%) compared with 38% (with individual studies ranging from 31% to 58%) without neuraxial anesthesia. The mean expected total delivery costs, including the cost of attempting/performing ECV with anesthesia, equaled $8931 (2.5th-97.5th percentile prediction interval $8541-$9252). The cost was $9207 (2.5th-97.5th percentile prediction interval $8896-$9419) if ECV was attempted/performed without anesthesia. The expected mean incremental difference between the total cost of delivery that includes ECV with anesthesia and ECV without anesthesia was $-276 (2.5th-97.5th percentile prediction interval $-720 to $112). The total cost of delivery in women with breech presentation may be decreased (up to $720) or increased (up to $112) if ECV is attempted/performed with neuraxial anesthesia compared with ECV without neuraxial anesthesia. Increased ECV success with neuraxial anesthesia and the subsequent reduction in breech cesarean delivery rate offset the costs of providing anesthesia to facilitate ECV.

  4. Expertise in physiological breech birth: A mixed-methods study.

    Science.gov (United States)

    Walker, Shawn; Parker, Pam; Scamell, Mandie

    2018-06-01

    The safety of vaginal breech birth depends on the expertise of birth attendants, yet the meaning of "expertise" remains unclear and subjectively defined. The objective of this study was to define expertise and the roles experts may play in expanding access to this service. We performed an integrative analysis of two strands of data concerning expertise in physiological breech birth, including the following: survey data from a Delphi study involving 26 very experienced clinicians (mean experience = 135 breech births) and 2 service user representatives, and interviews from a grounded theory study of 14 clinicians more moderately experienced with physiological methods (5-30 upright breech births). Data were pooled and analyzed using constant comparative methods. Expertise is defined by its ongoing function, the generation of comparatively good outcomes, and confidence and competence among colleagues. Although clinical experience is important, expertise is developed and expressed in social clinical roles, which expand as experience grows: clinician, mentor, specialist, and expert. To develop expertise within a service, clinicians who have an interest in breech birth should be supported to perform these roles within specialist teams. Specialist breech teams may facilitate the development of expertise within maternity care settings. Evaluation of expertise based on enablement of women and colleagues, as well as outcomes, will potentially avoid the pitfalls of alienation produced by some forms of specialist authority. © 2017 Wiley Periodicals, Inc.

  5. Risk of developmental dysplasia of the hip in breech presentation: the effect of successful external cephalic version.

    Science.gov (United States)

    Lambeek, A F; De Hundt, M; Vlemmix, F; Akerboom, B M C; Bais, J M J; Papatsonis, D N M; Mol, B W J; Kok, M

    2013-04-01

    To evaluate the effect of successful external cephalic version on the incidence of developmental dysplasia of the hip (DDH) requiring treatment in singleton breech presentation at term. Observational cohort study. Three large teaching hospitals in the Netherlands. Women with a singleton breech presentation of 34 weeks of gestation or more, who underwent an external cephalic version attempt. We made a comparison of the incidence of DDH between children born in breech presentation and children born in cephalic presentation after a successful external cephalic version. The incidence of DDH requiring either conservative treatment, with a harness, or surgical treatment. A total of 498 newborns were included in the study, of which 40 (8%) were diagnosed with DDH and 35 required treatment. Multivariate analysis showed that female gender (OR 2.79, 95% CI 1.23-6.35) and successful external cephalic version (OR 0.29, 95% CI 0.09-0.95) were independently associated with DDH. A successful external cephalic version is associated with a lower incidence of DDH, although a high percentage of children born after a successful external cephalic version still appear to have DDH. A larger cohort study is needed to establish the definite nature of this relationship. Until then, we recommend the same screening policy for infants born in cephalic position after a successful external cephalic version as for infants born in breech position. © 2012 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2012 RCOG.

  6. [Impact of the external cephalic version on the obstetrical prognosis in a team with a high success rate of vaginal delivery in breech presentation].

    Science.gov (United States)

    Coppola, C; Mottet, N; Mariet, A S; Baeza, C; Poitrey, E; Bourtembourg, A; Ramanah, R; Riethmuller, D

    2016-10-01

    To analyse the impact of external cephalic version (ECV) on caesarean section rate in a team with a high success rate of vaginal delivery in breech presentation. Retrospective monocentric study including 298 patients with a breech presentations between 33 and 35weeks of amenorrhea followed at our university hospital and delivered after 35weeks, between 1st January 2011 and 31st December 2013. Patients were divided into 2 groups: planned ECV (n=216 patients) versus no planned ECV (n=57 patients). Our rate of successful vaginal breech delivery over the period of the study was 61.1%. We performed 165 ECV, with a 21.8% success rate. The average term of the attempt of ECV was 36.7weeks of amenorrhea. The caesarean section rate was not significantly different in the planned ECV group, even after adjustment on age, parity and previous caesarean delivery (adjusted OR=1.67 [0.77-3.61]). Attempt of ECV did not reduce the number of breech presentation at delivery (61.1% versus 61.4% [P=0.55]). Planned ECV in our center with a high level of breech vaginal delivery did not significantly impact our cesarean section rate. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  7. Case of pituitary stalk transection syndrome ascertained after breech delivery.

    Science.gov (United States)

    Fukuta, Kaori; Hidaka, Takao; Ono, Yosuke; Kochi, Keiko; Yasoshima, Kuniaki; Arai, Takashi

    2016-02-01

    Pituitary stalk transection syndrome (PSTS) is a rare complication that can accompany breech delivery. Early diagnosis of this syndrome is difficult, and it may cause a serious delay in the diagnosis. We present a case of PSTS ascertained after breech delivery. A 20-year-old woman presented with primary amenorrhea. The patient was born by breech delivery and had a history of treatment for pituitary dwarfism. Her laboratory findings showed pituitary hypothyroidism, and hormone replacement therapy was initiated. At 28 years old, she became pregnant and had a normal delivery at 38 weeks' gestation. One year after delivery, her thyroid hormone level changed. Laboratory test showed adrenocortical insufficiency, and magnetic resonance imaging of the pituitary gland showed transection of the pituitary stalk and development of an ectopic posterior lobe. These findings were compatible with PSTS. When a patient who has been born by breech delivery presents with symptoms of pituitary deficiency, PSTS should be considered in the differential diagnosis. © 2015 Japan Society of Obstetrics and Gynecology.

  8. External cephalic version before elective caesarean section for breech presentation

    International Nuclear Information System (INIS)

    Zafar, F.; Sanusi, A.

    2008-01-01

    The Royal College of Obstetrics and Gynaecology guidelines state that all uncomplicated breech Presentation should be offered external cephalic version and all such women should be briefed about the risks and benefits of external cephalic version and all such women should be briefed about the risks and benefits of external cephalic version before undertaking the procedure. To ascertain the acceptability of external cephalic version before elective caesarean section for breech Presentation by pregnant ladies and see whether they were adequately informed about the risks and benefits. The clinical audit was registered with the audit department at Watford general hospital and written Consent for the access of medical records was obtained. A retrospective view of 86 accessible medical records out of Total 110 elective breech caesarean sections was done over a period of one year. This retrospective study was conducted at the gynaecology and obstetrics department at Watford general hospital, Watford United Kingdom. Written consent for the access of medical records was obtained. All women who under went elective caesarean section due to breech presentation were included in the study. Out of a total of 110 elective breech caesarean sections performed, the data on 86 cases was selected for the final analysis. The information gathered included patient's profile, whether patient was informed of risks and benefits of external cephalic version, recognition of obstetric risk factors, external cephalic version performed and its success. Out of total 86 caesarean sections 46 were suitable for external cephalic version of whom 37 cases were offered external cephalic version. Among 37 patients who were offered external cephalic version only 15 patients accepted (22 declined) the procedure. Moreover, it was found that the documentation of risk/benefit explanation of the procedure was inadequate. External cephalic version was not successful in any of the patient. Causes for

  9. [Fewer caesarean sections for breech presentation following external cephalic version according to a protocol in a special office visit].

    Science.gov (United States)

    Kuppens, S M I; Hasaart, T H M; van der Donk, M W P; Huibers, M; Franssen, M J; de Becker, B M J; Wijnen, H A A; Pop, V J M

    2008-06-07

    Identification of determinants affecting the outcome of external cephalic version (ECV) in breech presentation, and investigation of the impact of ECV--performed according to a standardized protocol in an outpatient clinic--on the mode of delivery. Retrospective analysis. In 2003 a standardized protocol of ECV was developed in the outpatient clinic for obstetrics of the Catharina Hospital in Eindhoven, the Netherlands; it was tested in 'version office visits'. Obstetric characteristics of all pregnant women who underwent attempts of ECV in the clinic from January 2004 until June 2006 during these sessions, and the subsequent births, were analysed. 85% of all ECVs were performed by the same hospital midwife and gynaecologist, in accordance with the protocol. ECV was successful in 96 of 209 pregnant women (46%). In 1 pregnant woman an emergency caesarean section was performed after ECV because of partial abruptio placentae. Nulliparity, incomplete breech presentation and low birth weight of the baby were associated with a lower success rate of ECV in this study. In the group with a successful ECV the percentage of caesarean deliveries was substantially lower (9 versus 83%; odds ratio: 0.21; 95% CI: 0.09-0.51). A regular team consisting of a hospital midwife and a gynaecologist working according to a standardized protocol for ECV in a case of breech presentation proved successful: the number of term breech presentations substantially diminished and therefore the percentage of caesarean sections was lower in the group in which ECV had been successful. This could have considerable impact on health care in the Netherlands in terms of reduced maternal morbidity and cost savings.

  10. Disproportionate Intrauterine Growth Intervention Trial At Term: DIGITAT

    Directory of Open Access Journals (Sweden)

    Huisjes Anjoke JM

    2007-07-01

    Full Text Available Abstract Background Around 80% of intrauterine growth restricted (IUGR infants are born at term. They have an increase in perinatal mortality and morbidity including behavioral problems, minor developmental delay and spastic cerebral palsy. Management is controversial, in particular the decision whether to induce labour or await spontaneous delivery with strict fetal and maternal surveillance. We propose a randomised trial to compare effectiveness, costs and maternal quality of life for induction of labour versus expectant management in women with a suspected IUGR fetus at term. Methods/design The proposed trial is a multi-centre randomised study in pregnant women who are suspected on clinical grounds of having an IUGR child at a gestational age between 36+0 and 41+0 weeks. After informed consent women will be randomly allocated to either induction of labour or expectant management with maternal and fetal monitoring. Randomisation will be web-based. The primary outcome measure will be a composite neonatal morbidity and mortality. Secondary outcomes will be severe maternal morbidity, maternal quality of life and costs. Moreover, we aim to assess neurodevelopmental and neurobehavioral outcome at two years as assessed by a postal enquiry (Child Behavioral Check List-CBCL and Ages and Stages Questionnaire-ASQ. Analysis will be by intention to treat. Quality of life analysis and a preference study will also be performed in the same study population. Health technology assessment with an economic analysis is part of this so called Digitat trial (Disproportionate Intrauterine Growth Intervention Trial At Term. The study aims to include 325 patients per arm. Discussion This trial will provide evidence for which strategy is superior in terms of neonatal and maternal morbidity and mortality, costs and maternal quality of life aspects. This will be the first randomised trial for IUGR at term. Trial registration Dutch Trial Register and ISRCTN

  11. Detecting Breech Presentation Before Labour: Lessons From a Low-Risk Maternity Clinic.

    Science.gov (United States)

    Ressl, Bill; O'Beirne, Maeve

    2015-08-01

    Evaluation of fetal position is an important part of prenatal care. A woman with a breech presentation may need referral for external cephalic version, for assisted breech delivery, or to schedule a Caesarean section. In many centres, a breech presentation undetected until labour will result in an emergency Caesarean section, a less desirable alternative for both the mother and the health care system. The anecdotal reports of undiagnosed breech presentations at a busy maternity clinic prompted a study to quantify the missed breech presentations and to evaluate the effectiveness of the current detection process, with the aim of allowing no more than 1% of breech presentations to remain undetected until labour. We performed a retrospective analysis of 102 breech deliveries over a 14 month period to quantify missed breech presentations, and used a prospective physician survey documenting how fetal presentation was determined at 186 prenatal visits over four months to analyze the current detection process. We found that approximately 8% of breech presentations were undetected until labour. We concluded that within the limitations of the small sample size evaluated, the current practice of using a vaginal examination to verify fetal presentation determined by abdominal palpation (Leopold's manoeuvres) may not be more accurate than abdominal palpation alone. The current detection process resulted in an unacceptably high rate of missed breech presentations. The results of this study prompted the clinic's acquisition of bedside ultrasound capability to assess fetal position.

  12. Trial-to-Trial Carryover in Auditory Short-Term Memory

    Science.gov (United States)

    Visscher, Kristina M.; Kahana, Michael J.; Sekuler, Robert

    2009-01-01

    Using a short-term recognition memory task, the authors evaluated the carryover across trials of 2 types of auditory information: the characteristics of individual study sounds (item information) and the relationships between the study sounds (study set homogeneity). On each trial, subjects heard 2 successive broadband study sounds and then…

  13. On Intelligent Design and Planning Method of Process Route Based on Gun Breech Machining Process

    Science.gov (United States)

    Hongzhi, Zhao; Jian, Zhang

    2018-03-01

    The paper states an approach of intelligent design and planning of process route based on gun breech machining process, against several problems, such as complex machining process of gun breech, tedious route design and long period of its traditional unmanageable process route. Based on gun breech machining process, intelligent design and planning system of process route are developed by virtue of DEST and VC++. The system includes two functional modules--process route intelligent design and its planning. The process route intelligent design module, through the analysis of gun breech machining process, summarizes breech process knowledge so as to complete the design of knowledge base and inference engine. And then gun breech process route intelligently output. On the basis of intelligent route design module, the final process route is made, edited and managed in the process route planning module.

  14. A Rare Complication of a Vaginal Breech Delivery

    Directory of Open Access Journals (Sweden)

    H. C. Vergers-Spooren

    2011-01-01

    Full Text Available Rectal lesions without anal sphincter trauma in childbirth are only sporadically described in literature. We describe the case of a 29-year-old primigravida who delivered a child in frank breech presentation. During the second stage of labour a foot presented transanally through a rectal laceration with intact anal sphincters. The laceration was repaired immediately after delivery in theatre. Follow-up visits showed a properly cured laceration and no complaints of incontinence or foul discharge.

  15. Long-term dietary intervention trials: critical issues and challenges

    Directory of Open Access Journals (Sweden)

    Crichton Georgina E

    2012-07-01

    Full Text Available Abstract Background There are many challenges involved in running randomised controlled dietary intervention trials that investigate health outcomes. The aim of this paper was to evaluate the recruitment process, retention of participants and challenges faced in our dairy intervention trial, and to provide strategies to combat the difficulties of running long-term dietary intervention trials. Methods A 12-month, randomised, two-way crossover study was conducted in overweight adults with habitually low dairy food consumption to assess the effects of a high dairy intake (4 servings of reduced-fat dairy per day compared with a low dairy intake (1 serving of reduced-fat dairy per day on measures of cardiometabolic and cognitive health. On completion of the high dairy intake phase, each participant was interviewed about their experience in the trial and responses were used to evaluate the key issues for study participants. Results Although the recruitment target was achieved, high rates of attrition (49.3% and difficulties maintaining participant compliance (reported by 37.8% of participants were major threats to the viability of the study. Factors that contributed to the high attrition included inability to comply with the dietary requirements of the study protocol (27.0%, health problems or medication changes (24.3% and time commitment (10.8%. Conclusion Attrition and adherence to study requirements present challenges to trials requiring longer-term dietary change. Including a run-in period to further assess the motivation, commitment and availability of participants, maintaining regular contact with participants during control phases, minimising time commitment, providing flexibility with dietary requirements, facilitating positive experiences, and stringent monitoring of diet are some key recommendations for future dietary intervention trials. Trial registration Australia and New Zealand Clinical Trials Registry (ACTRN 12608000538347

  16. Retention of Vaginal Breech Delivery Skills Taught in Simulation.

    Science.gov (United States)

    Stone, Heather; Crane, Joan; Johnston, Kathy; Craig, Catherine

    2018-02-01

    The optimal frequency of conducting simulation training for high-acuity, low-frequency events in obstetrics and gynaecology residency programs is unknown. This study evaluated retention over time of vaginal breech delivery skills taught in simulation, by comparing junior and senior residents. In addition, the residents' subjective comfort level to perform this skill clinically was assessed. This prospective cohort study included 22 obstetrics and gynaecology residents in a Canadian residency training program. Digital recordings were completed for pre-training, immediate post-training, and delayed (10-26 weeks later) post-training intervals of a vaginal breech delivery simulation, with skill assessment by a blinded observer using a binary checklist. Residents also completed questionnaires to assess their subjective comfort level at each interval. Junior and senior residents had significant improvements in vaginal breech delivery skills from the pre-training assessment to both the immediate post-training assessment (junior, P simulation 10-26 weeks later, although a decline in skills occurred over this time period. Comfort level was positively affected and retained. These results will aid in determining the frequency of simulation teaching for high-acuity, low-frequency events in a residency simulation curriculum. Copyright © 2018 Society of Obstetricians and Gynaecologists of Canada. Published by Elsevier Inc. All rights reserved.

  17. Breech delivery at term in Denmark, 1982-92

    DEFF Research Database (Denmark)

    Krebs, L; Langhoff-Roos, J

    1999-01-01

    ,476) in Denmark, 1982-92, a review of medical records of all (n = 218) cases with Apgar score controls, was performed. Planned vaginal delivery was associated with a 15 times greater risk of low Apgar score than elective Caesarean section...

  18. Nifedipine as a uterine relaxant for external cephalic version: a randomized controlled trial

    NARCIS (Netherlands)

    Kok, Marjolein; Bais, Joke M.; van Lith, Jan M.; Papatsonis, Dimitri M.; Kleiverda, Gunilla; Hanny, Dahrs; Doornbos, Johannes P.; Mol, Ben W.; van der Post, Joris A.

    2008-01-01

    OBJECTIVE: To estimate the effectiveness of nifedipine as a uterine relaxant during external cephalic version to correct breech presentation. METHODS: In this randomized, double-blind, placebo-controlled trial, women with a singleton fetus in breech presentation and a gestational age of 36 weeks or

  19. Breech deliveries in Usmanu Danfodiyo University Teaching Hospital Sokoto, Northwestern Nigeria: A 10-year review

    Directory of Open Access Journals (Sweden)

    Karima Tunau

    2013-01-01

    Full Text Available Background: Breech delivery is a major issue in obstetric practice mainly because of the high perinatal morbidity and mortality associated with it. The aims of the study are to determine the prevalence management and perinatal outcome of singleton breech deliveries in our center. Materials and Methods: A retrospective study involving 395 singleton breech deliveries out of 24,160 deliveries conducted at the Usmanu Danfodiyo University Teaching Hospital Sokoto, Sokoto, over a 10-year (2001-2010 period. Results: The prevalence rate of singleton breech delivery was 1.7%. Breech deliveries occurred more in the primigravidae. Most babies (69.1% had vaginal delivery. There was a high caesarean section (CS rate of 30.9%. Babies delivered by CS had better Apgar scores than those delivered through the vagina (P < 0.05. The perinatal mortality rate in breech deliveries (410/1000 was significantly higher than that (101.5/10000 in their cephalic counterparts (P < 0.05. Similarly, perinatal deaths were more common in unbooked than in booked patients (P < 0.05. Conclusion: Breech delivery was frequent in the study population. Singleton breech delivered by CS had better outcome than those who were delivered through the vagina.

  20. Induction versus expectant monitoring for intrauterine growth restriction at term : randomised equivalence trial (DIGITAT)

    NARCIS (Netherlands)

    Boers, K. E.; Vijgen, S. M. C.; Bijlenga, D.; van der Post, J. A. M.; Bekedam, D. J.; Kwee, A.; van der Salm, P. C. M.; van Pampus, M. G.; Spaanderman, M. E. A.; de Boer, K.; Duvekot, J. J.; Bremer, H. A.; Hasaart, T. H. M.; Delemarre, F. M. C.; Bloemenkamp, K. W. M.; van Meir, C. A.; Willekes, C.; Wijnen, E. J.; Rijken, M.; le Cessie, S.; Roumen, F. J. M. E.; Thornton, J. G.; van Lith, J. M. M.; Mol, B. W. J.; Scherjon, S. A.

    2010-01-01

    Objective To compare the effect of induction of labour with a policy of expectant monitoring for intrauterine growth restriction near term. Design Multicentre randomised equivalence trial (the Disproportionate Intrauterine Growth Intervention Trial At Term (DIGITAT)). Setting Eight academic and 44

  1. Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT)

    NARCIS (Netherlands)

    Boers, K.E.; Vijgen, S.M.C.; Bijlenga, D.; van der Post, J.A.M.; Bekedam, D.J.; Kwee, A.; van der Salm, P.C.M.; van Pampus, M.G.; Spaanderman, M.E.A.; Boer, K.; Duvekot, J.J.; Bremer, H.A.; Hasaart, T.H.M.; Delemarre, F.M.C.; Bloemenkamp, K.W.M.; van Meir, C.A.; Willekes, C.; Wijnen, E.J.; Rijken, M.; le Cessie, S.; Roumen, F.J.M.E.; Thornton, J.G.; van Lith, J.M.M.; Mol, B.W.J.; Scherjon, S.A.

    2010-01-01

    Objective To compare the effect of induction of labour with a policy of expectant monitoring for intrauterine growth restriction near term. Design Multicentre randomised equivalence trial (the Disproportionate Intrauterine Growth Intervention Trial At Term (DIGITAT)). Setting Eight academic and 44

  2. Clinical trials with rasagiline: evidence for short-term and long-term effects.

    Science.gov (United States)

    Siderowf, Andrew; Stern, Matthew

    2006-05-23

    Rasagiline (N-propargyl-1 (R)-aminoindan) is a selective, potent irreversible inhibitor of MAO-B that possesses neuroprotective and anti-apoptotic properties in a variety of in vitro and in vivo animal models relevant to Parkinson's disease (PD). Several randomized controlled clinical trials have demonstrated the safety and efficacy of rasagiline as monotherapy in PD and as adjunctive therapy for patients receiving levodopa. In addition, the 1-year randomized, delayed-start analysis of the TEMPO study suggests that rasagiline may slow the rate of progression of PD. The randomized delayed-start paradigm has potential to differentiate short-term symptomatic effects from long-term effects of anti-parkinsonian agents. In the future, long-term trials to examine the potential disease-modifying effects of rasagiline, which incorporate biological markers as well as clinical endpoints, may further elucidate the role of rasagiline in the treatment of both early and advanced PD.

  3. Deliberate acquisition of competence in physiological breech birth: A grounded theory study.

    Science.gov (United States)

    Walker, Shawn; Scamell, Mandie; Parker, Pam

    2018-06-01

    Research suggests that the skill and experience of the attendant significantly affect the outcomes of vaginal breech births, yet practitioner experience levels are minimal within many contemporary maternity care systems. Due to minimal experience and cultural resistance, few practitioners offer vaginal breech birth, and many practice guidelines and training programmes recommend delivery techniques requiring supine maternal position. Fewer practitioners have skills to support physiological breech birth, involving active maternal movement and choice of birthing position, including upright postures such as kneeling, standing, squatting, or on a birth stool. How professionals learn complex skills contrary to those taught in their local practice settings is unclear. How do professionals develop competence and expertise in physiological breech birth? Nine midwives and five obstetricians with experience facilitating upright physiological breech births participated in semi-structured interviews. Data were analysed iteratively using constructivist grounded theory methods to develop an empirical theory of physiological breech skill acquisition. Among the participants in this research, the deliberate acquisition of competence in physiological breech birth included stages of affinity with physiological birth, critical awareness, intention, identity and responsibility. Expert practitioners operating across local and national boundaries guided less experienced practitioners. The results depict a specialist learning model which could be formalised in sympathetic training programmes, and evaluated. It may also be relevant to developing competence in other specialist/expert roles and innovative practices. Deliberate development of local communities of practice may support professionals to acquire elusive breech skills in a sustainable way. Copyright © 2017 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.

  4. Antibiotic prophylaxis for term or near-term premature rupture of membranes: metaanalysis of randomized trials.

    Science.gov (United States)

    Saccone, Gabriele; Berghella, Vincenzo

    2015-05-01

    The objective of the study was to evaluate the efficacy of antibiotic prophylaxis in women with term or near-term premature rupture of membranes. Searches were performed in MEDLINE, OVID, Scopus, ClinicalTrials.gov, the PROSPERO International Prospective Register of Systematic Reviews, EMBASE, ScienceDirect.com, MEDSCAPE, and the Cochrane Central Register of Controlled Trials with the use of a combination of key words and text words related to antibiotics, premature rupture of membranes, term, and trials from inception of each database to September 2014. We included all randomized trials of singleton gestations with premature rupture of membranes at 36 weeks or more, who were randomized to antibiotic prophylaxis or control (either placebo or no treatment). The primary outcomes included maternal chorioamnionitis and neonatal sepsis. A subgroup analysis on studies with latency more than 12 hours was planned. Before data extraction, the review was registered with the PROSPERO International Prospective Register of Systematic Reviews (registration number CRD42014013928). The metaanalysis was performed following the Preferred Reporting Item for Systematic Reviews and Meta-analyses statement. Women who received antibiotics had the same rate of chorioamnionitis (2.7% vs 3.7%; relative risk [RR], 0.73, 95% confidence interval [CI], 0.48-1.12), endometritis (0.4% vs 0.9%; RR, 0.44, 95% CI, 0.18-1.10), maternal infection (3.1% vs 4.6%; RR, 0.48, 95% CI, 0.19-1.21), and neonatal sepsis (1.0% vs 1.4%; RR, 0.69, 95% CI, 0.34-1.39). In the planned subgroup analysis, women with latency longer than 12 hours, who received antibiotics, had a lower rate of chorioamnionitis (2.9% vs 6.1%; RR, 0.49, 95% CI, 0.27-0.91) and endometritis (0% vs 2.2%; RR, 0.12, 95% CI, 0.02-0.62) compared with the control group. Antibiotic prophylaxis for term or near-term premature rupture of membranes is not associated with any benefits in either maternal or neonatal outcomes. In women with latency longer

  5. Impact of the mode of delivery on maternal and neonatal outcome in spontaneous-onset breech labor at 32+0-36+6 weeks of gestation: A retrospective cohort study.

    Science.gov (United States)

    Toivonen, Elli; Palomäki, Outi; Korhonen, Päivi; Huhtala, Heini; Uotila, Jukka

    2018-03-30

    To compare neonatal and maternal outcomes in spontaneously onset preterm breech deliveries after trial of labor (BTOL) and intended cesarean section (BCS), and between BTOL and vertex control deliveries, in singleton fetuses at 32 +0 -36 +6  weeks of gestation. Retrospective single center cohort study in a Finnish University Hospital including all spontaneous-onset preterm breech deliveries with 32 completed gestational weeks in 2003-2015. The study population comprised a total of 176 preterm breech and 103 vertex control deliveries, matched by gestational age and whether the mother had given birth vaginally before or not. Infants with severe malformations and antepartum fetal distress were excluded. Subgroup analyses were made in two cohorts according to gestational age. Main outcome measures were maternal and neonatal mortality and morbidity, low cord pH and Apgar score. No mortality was observed, and severe morbidity was rare. No difference in incidence of low cord pH or five-minute Apgar score was observed between the groups. Apgar scores at the age of one minute were comparable in the breech groups but more often low in the BTOL group compared to the vertex control group. 16.5% of neonates in the BTOL group, 23.3% in the BCS group and 7.8% in the vertex group needed intensive care. In logistic regression analysis, lower gestational age and being small for gestational age were associated with the need for neonatal intensive care. Being allowed a trial of labor was not associated with the need for neonatal intensive care. Maternal morbidity was similar across the groups, but median blood loss was more pronounced in the BCS group compared to the BTOL group. In breech deliveries at 32 +0 -36 +6 gestational weeks, trial of labor did not increase neonatal morbidity compared to intended cesarean delivery. Infants born after a trial of labor in breech presentation display low one-minute Apgar score and need intensive care more often compared to vertex controls

  6. Dispersant trial at ANO-2: Results from a short-term trial prior to SG replacement

    International Nuclear Information System (INIS)

    Fruzzetti, K.; Frattini, P.; Robbins, P.; Miller, A.; Varrin, R.; Kreider, M.

    2002-01-01

    Corrosion products in the secondary side of pressurized water reactor (PWR) steam generators (SGs) primarily deposit on the SG tubes. These deposits can inhibit heat transfer, lead to thermal-hydraulic instabilities through blockage of tube supports, and create occluded regions where corrosive species can concentrate along tubes and in tube-to-tube support plate crevices. The performance of the SGs is compromised not only by formation of an insulating scale, but by the removal of tubes from service due to corrosion. A potential strategy for minimizing deposition of corrosion products on SG internal surfaces is to use an online dispersant to help prevent the corrosion products from adhering to the steam generator surfaces. By inhibiting the deposition of the corrosion products, the dispersant can facilitate more effective removal from the SGs via blowdown. This type of strategy has been employed at fossil boilers for many decades. However, due to the use of inorganic (sulfur and other impurities) polymerization initiators, polymeric dispersants had not been utilized in the nuclear industry. Only recently has a poly-acrylic acid dispersant, developed by BetzDearborn (PAA), been available that meets the criteria for nuclear application. This paper summarizes the results of the short-term PAA dispersant trial in Winter/Spring 2000, lasting approximately 3 months, performed at Arkansas nuclear one unit 2 (ANO-2)-including the chronology of the trial, the increase in blowdown iron removal efficiency with use of the dispersant, and observed effects on SG performance. (authors)

  7. Dispersant trial at ANO-2: Results from a short-term trial prior to SG replacement

    Energy Technology Data Exchange (ETDEWEB)

    Fruzzetti, K.; Frattini, P. [Electric Power Research Inst., Palo Alto, CA (United States); Robbins, P. [Entergy Operations, Arkansas Nuclear One, Russellville, AR (United States); Miller, A. [Pedro Point Technology, Inc., Pacifica, CA (United States); Varrin, R.; Kreider, M. [Dominion Engineering Inc., McLean, VA (United States)

    2002-07-01

    Corrosion products in the secondary side of pressurized water reactor (PWR) steam generators (SGs) primarily deposit on the SG tubes. These deposits can inhibit heat transfer, lead to thermal-hydraulic instabilities through blockage of tube supports, and create occluded regions where corrosive species can concentrate along tubes and in tube-to-tube support plate crevices. The performance of the SGs is compromised not only by formation of an insulating scale, but by the removal of tubes from service due to corrosion. A potential strategy for minimizing deposition of corrosion products on SG internal surfaces is to use an online dispersant to help prevent the corrosion products from adhering to the steam generator surfaces. By inhibiting the deposition of the corrosion products, the dispersant can facilitate more effective removal from the SGs via blowdown. This type of strategy has been employed at fossil boilers for many decades. However, due to the use of inorganic (sulfur and other impurities) polymerization initiators, polymeric dispersants had not been utilized in the nuclear industry. Only recently has a poly-acrylic acid dispersant, developed by BetzDearborn (PAA), been available that meets the criteria for nuclear application. This paper summarizes the results of the short-term PAA dispersant trial in Winter/Spring 2000, lasting approximately 3 months, performed at Arkansas nuclear one unit 2 (ANO-2)-including the chronology of the trial, the increase in blowdown iron removal efficiency with use of the dispersant, and observed effects on SG performance. (authors)

  8. Elective Caesarean Section for Breech Presentation in First Pregnancy and Subsequent Mode of Labour

    International Nuclear Information System (INIS)

    Khaskheli, M.; Baloch, S.; Sheeba, A.

    2014-01-01

    Objective: To determine the effect on subsequent mode of labour in case of previous elective caesarean for breech presentation in primiparous women. Study Design: A cohort study. Place and Duration of Study: Department of Obstetrics and Gynaecology, Liaquat University of Medical and Health Sciences, Jamshoro, Unit-1 and 1V, from January 2005 to December 2009. Methodology: All women with previous one elective caesarean section for breech or cephalic presentation visited OPD for antenatal checkup or admitted in emergency in maternity or labour ward were recruited for the study, while the women with previous 2 and 3 caesarean section were excluded from the study. The case records of these women were reviewed thoroughly, and entered in predesigned proforma. The main outcome measure was mode of labour in current pregnancy decided electively or adopted in emergency. Results: Out of the total, 131 (16.92%) women had previous elective caesarean section due to breech presentation while 643 (83.07%) women had previous elective caesarean section with cephalic presentation. Overall repeat caesarean section rate was 92 (70.22%) in women with previous breech presentation (n=131) in comparison with 475 (73.87%) women with previous cephalic presentation n=643 (RR=1.04, p=0.32). The vaginal birth rate after elective caesarean section due to breech presentation was 39 (29.77%) in comparison with 168 (26.12%) cases with previous cephalic presentation (RR=0.98, p=0.83). Conclusion: Women having elective caesarean section for breech presentation in their previous pregnancy had about 1 in 6 chance of having repeat elective caesarean section. (author)

  9. Fractional Brownian motion and long term clinical trial recruitment.

    Science.gov (United States)

    Zhang, Qiang; Lai, Dejian

    2011-05-01

    Prediction of recruitment in clinical trials has been a challenging task. Many methods have been studied, including models based on Poisson process and its large sample approximation by Brownian motion (BM), however, when the independent incremental structure is violated for BM model, we could use fractional Brownian motion to model and approximate the underlying Poisson processes with random rates. In this paper, fractional Brownian motion (FBM) is considered for such conditions and compared to BM model with illustrated examples from different trials and simulations.

  10. Experiences of a long-term randomized controlled prevention trial in a maiden environment: Estonian Postmenopausal Hormone Therapy trial

    Directory of Open Access Journals (Sweden)

    Rahu Mati

    2008-08-01

    Full Text Available Abstract Background Preventive drugs require long-term trials to show their effectiveness or harms and often a lot of changes occur during post-marketing studies. The purpose of this article is to describe the research process in a long-term randomized controlled trial and discuss the impact and consequences of changes in the research environment. Methods The Estonian Postmenopausal Hormone Therapy trial (EPHT, originally planned to continue for five years, was planned in co-operation with the Women's International Study of Long-Duration Oestrogen after Menopause (WISDOM in the UK. In addition to health outcomes, EPHT was specifically designed to study the impact of postmenopausal hormone therapy (HT on health services utilization. Results After EPHT recruited in 1999–2001 the Women's Health Initiative (WHI in the USA decided to stop the estrogen-progestin trial after a mean of 5.2 years in July 2002 because of increased risk of breast cancer and later in 2004 the estrogen-only trial because HT increased the risk of stroke, decreased the risk of hip fracture, and did not affect coronary heart disease incidence. WISDOM was halted in autumn 2002. These decisions had a major influence on EPHT. Conclusion Changes in Estonian society challenged EPHT to find a balance between the needs of achieving responses to the trial aims with a limited budget and simultaneously maintaining the safety of trial participants. Flexibility was the main key for success. Rapid changes are not limited only to transiting societies but are true also in developed countries and the risk must be included in planning all long-term trials. The role of ethical and data monitoring committees in situations with emerging new data from other studies needs specification. Longer funding for preventive trials and more flexibility in budgeting are mandatory. Who should prove the effectiveness of an (old drug for a new preventive indication? In preventive drug trials companies may

  11. Dispersant trial at ANO-2: Qualification for a short-term trial prior to SG replacement

    International Nuclear Information System (INIS)

    Fruzzetti, K.; Frattini, P.; Robbins, P.; Miller, A.; Varrin, R.; Kreider, M.

    2002-01-01

    initiators, polymeric dispersants had not been utilized in the nuclear industry. Only recently has a poly-acrylic acid dispersant, developed by BetzDearborn (PAA), been available off the shelf that meets the criteria for nuclear application. This paper summarizes the qualification program designed to qualify the PAA dispersant for the short-term trial at ANO-2 prior to SG replacement. (authors)

  12. Dispersant trial at ANO-2: Qualification for a short-term trial prior to SG replacement

    Energy Technology Data Exchange (ETDEWEB)

    Fruzzetti, K.; Frattini, P. [Electric Power Research Inst., Palo Alto, CA (United States); Robbins, P. [Entergy Operations, Arkansas Nuclear One, Russellville, AR (United States); Miller, A. [Pedro Point Technology, Inc., Pacifica, CA (United States); Varrin, R.; Kreider, M. [Dominion Engineering Inc., McLean, VA (United States)

    2002-07-01

    initiators, polymeric dispersants had not been utilized in the nuclear industry. Only recently has a poly-acrylic acid dispersant, developed by BetzDearborn (PAA), been available off the shelf that meets the criteria for nuclear application. This paper summarizes the qualification program designed to qualify the PAA dispersant for the short-term trial at ANO-2 prior to SG replacement. (authors)

  13. Trial-to-trial dynamics of selective long-term-memory retrieval with continuously changing retrieval targets.

    Science.gov (United States)

    Kizilirmak, Jasmin M; Rösler, Frank; Khader, Patrick H

    2014-10-01

    How do we control the successive retrieval of behaviorally relevant information from long-term memory (LTM) without being distracted by other potential retrieval targets associated to the same retrieval cues? Here, we approach this question by investigating the nature of trial-by-trial dynamics of selective LTM retrieval, i.e., in how far retrieval in one trial has detrimental or facilitatory effects on selective retrieval in the following trial. Participants first learned associations between retrieval cues and targets, with one cue always being linked to three targets, forming small associative networks. In successive trials, participants had to access either the same or a different target belonging to either the same or a different cue. We found that retrieval times were faster for targets that had already been relevant in the previous trial, with this facilitatory effect being substantially weaker when the associative network changed in which the targets were embedded. Moreover, staying within the same network still had a facilitatory effect even if the target changed, which became evident in a relatively higher memory performance in comparison to a network change. Furthermore, event-related brain potentials (ERPs) showed topographically and temporally dissociable correlates of these effects, suggesting that they result from combined influences of distinct processes that aid memory retrieval when relevant and irrelevant targets change their status from trial to trial. Taken together, the present study provides insight into the different processing stages of memory retrieval when fast switches between retrieval targets are required. Copyright © 2014 Elsevier Inc. All rights reserved.

  14. The breech presentation and the vertex presentation following an external version represent risk factors for neonatal hip instability.

    Science.gov (United States)

    Andersson, J E; Odén, A

    2001-08-01

    The aim of this study was to evaluate the frequency and type of hip-joint instability and the frequency of hip dislocation requiring treatment in neonates who had been lying in the breech presentation and were delivered vaginally after an external version or by caesarean section, and to compare them with neonates who were naturally in the vertex presentation. Breech presentations without ongoing labour were subjected to an attempted external version and, in cases where this proved unsuccessful or where labour had started, to deliver by caesarean section. None of the breech presentations was vaginally delivered. The anterior-dynamic ultrasound method was used to assess the hip-joint status of the neonates. Out of 6,571 foetuses, 257 were in breech presentation after 36 wk of pregnancy. Sixty-two were vaginally delivered following an external version to vertex presentation and 195 were delivered by caesarean section, 75 of these following unsuccessful attempts to perform a version. Treatment for congenital hip-joint dislocation was performed on 0.2%. Out of the breech presentations, 1.0% of those delivered by caesarean section were treated, while in those with vaginal delivery following an external version the treatment frequency was 3.2%. No case of late diagnosed hip dislocation was recorded. Significant differences in frequency of hip-joint instability and treatment were found between (i) neonates delivered in breech presentation and those delivered with vertex presentation, (ii) infants delivered in vertex presentation, naturally or after successful version, and (iii) those delivered by caesarean section with or without attempted external version and those delivered with vortex presentation. Breech presentation predisposes to increased hip instability. The instability is present prior to delivery and is certainly not a primary result of delivery forces. Both breech and vertex presentations following an external or spontaneous version should be considered as risk

  15. Care during the decision-making phase for women who want a vaginal breech birth: Experiences from the field.

    Science.gov (United States)

    Catling, C; Petrovska, K; Watts, N P; Bisits, A; Homer, C S E

    2016-03-01

    few women are given the option of a vaginal breech birth in Australia, unless the clinicians feel confident and have the skills to facilitate this mode of birth. Few studies describe how clinicians provide care during the decision-making phase for women who choose a vaginal breech birth. The aim of this study was to explore how experienced clinicians facilitated decisions about external cephalic version and mode of birth for women who have a breech presentation. a descriptive exploratory design was undertaken with nine experienced clinicians (obstetricians and midwives) from two tertiary hospitals in Australia. Data were collected through face to face interviews and analysed thematically. five obstetricians and four midwives participated in this study. All were experienced in caring for women having a vaginal breech birth and were currently involved in providing such a service. The themes that arose from the data were: Pitching the discussion, Discussing safety and risk, Being calm and Providing continuity of care. caring for women who seek a vaginal breech birth includes careful selection of appropriate women, full discussions outlining the risks involved, and undertaking care with a calm manner, ensuring continuity of care. Health services considering establishing a vaginal breech service should consider that these elements are included in the establishment and implementation processes. Copyright © 2015 Elsevier Ltd. All rights reserved.

  16. External cephalic version for singleton breech presentation: proposal of a practical check-list for obstetricians.

    Science.gov (United States)

    Indraccolo, U; Graziani, C; Di Iorio, R; Corona, G; Bonito, M; Indraccolo, S R

    2015-07-01

    External cephalic version (ECV) for breech presentation is not routinely performed by obstetricians in many clinical settings. The aim of this work is to assess to what extent the factors involved in performing ECV are relevant for the success and safety of ECV, in order to propose a practical check-list for assessing the feasibility of ECV. Review of 214 references. Factors involved in the success and risks of ECV (feasibility of ECV) were extracted and were scored in a semi-quantitative way according to textual information, type of publication, year of publication, number of cases. Simple conjoint analysis was used to describe the relevance found for each factor. Parity has the pivotal role in ECV feasibility (relevance 16.6%), followed by tocolysis (10.8%), gestational age (10.6%), amniotic fluid volume (4.7%), breech variety (1.9%), and placenta location (1.7%). Other factors with estimated relevance around 0 (regional anesthesia, station, estimated fetal weight, fetal position, obesity/BMI, fetal birth weight, duration of manoeuvre/number of attempts) have some role in the feasibility of ECV. Yet other factors, with negative values of estimated relevance, have even less importance. From a logical interpretation of the relevance of each factor assessed, ECV should be proposed with utmost prudence if a stringent check-list is followed. Such a check-list should take into account: parity, tocolytic therapy, gestational age, amniotic fluid volume, breech variety, placenta location, regional anesthesia, breech engagement, fetal well-being, uterine relaxation, fetal size, fetal position, fetal head grasping capability and fetal turning capability.

  17. Developmental dysplasia of hip screening using ortolani and barlow testing on breech delivered neonates.

    Science.gov (United States)

    Sulaiman, Ar; Yusof, Zakaria; Munajat, I; Lee, Naa; Zaki, Nik

    2011-11-01

    We conducted this study to compare the specificity and sensitivity of the Ortolani and Barlow tests performed by dedicated examiners, and to ascertain the incidence of developmental dysplasia of the hip (DDH) in breech babies. A dedicated examiner underwent specific training and testing by a paediatric orthopaedic surgeon. Routine examiners were medical officers who had basic training in medical school and were briefly trained by their superiors. The dedicated examiner examined 170 babies. Thirty babies including 5 babies with positive tests (according to the dedicated examiner) were examined by a blinded routine examiner. RESULTS of Ortolani and Barlow tests on 30 babies were compared with ultrasound examination by blinded radiologist. Five babies had positive Ortolani and Barlow tests. The routine examiner did not detect positive Ortolani and Barlow tests. The incidence of positive Ortolani and Barlow tests among breech babies was 2.8%. Result of Ortolani and Barlow tests by dedicated hip screener were better than results performed by routine examiner. Ortolani and Barlow, Dedicated Examiner, Routine Examiner, Breech, Ultrasound.

  18. Effect of Probiotics on Serum Bilirubin Level in Term Neonates with Jaundice; A Randomized Clinical Trial

    OpenAIRE

    Yadollah Zahed Pasha; Mousa Ahmadpour-kacho; Abes Ahmadi Jazi; Hemmat Gholinia

    2017-01-01

    Background In recent years, tendency to use drugs has been increasing in the treatment of neonatal jaundice. Several drugs have been used since then, but the effect of probiotics on serum bilirubin level (SBL) is not so clear. This study was conducted to evaluate the effect of probiotics on SBL and the duration of phototherapy in term neonates with hyperbilirubinemia. Materials and Methods: In this randomized clinical trial, we studied 150 term neonate with jaundice hospitalized for photother...

  19. Interaction of Inhibitory and Facilitatory Effects of Conditioning Trials on Long-Term Memory Formation

    Science.gov (United States)

    Hosono, Shouhei; Matsumoto, Yukihisa; Mizunami, Makoto

    2016-01-01

    Animals learn through experience and consolidate the memories into long-time storage. Conditioning parameters to induce protein synthesis-dependent long-term memory (LTM) have been the subject of extensive studies in many animals. Here we found a case in which a conditioning trial inhibits or facilitates LTM formation depending on the intervals…

  20. Bias due to withdrawal in long-term randomised trials in COPD

    DEFF Research Database (Denmark)

    Vestbo, Jørgen; Anderson, Julie Anne; Calverley, Peter Mark Anthony

    2011-01-01

    Randomised controlled trials (RCTs) are considered the least biased method for evaluating drug efficacy and several large long-term RCTs in chronic obstructive pulmonary disease have been published. These usually include drugs with symptomatic benefits and have significant withdrawal rates....

  1. Role of massage therapy on reduction of neonatal hyperbilirubinemia in term and preterm neonates: a review of clinical trials.

    Science.gov (United States)

    Garg, Bhawan Deep; Kabra, Nandkishor S; Balasubramanian, Haribalakrishna

    2017-09-13

    Neonatal hyperbilirubinemia (NNH) is one of the leading causes of admissions in nursery throughout the world. It affects approximately 2.4-15% of neonates during the first 2 weeks of life. To evaluate the role of massage therapy for reduction of NNH in both term and preterm neonates. The literature search was done for various randomized control trials (RCTs) by searching the Cochrane Library, PubMed, and EMBASE. This review included total of 10 RCTs (two in preterm neonates and eight in term neonates) that fulfilled inclusion criteria. In most of the trials, Field massage was given. Six out of eight trials reported reduction in bilirubin levels in term neonates. However, only one trial (out of two) reported significant reduction in bilirubin levels in preterm neonates. Both trials in preterm neonates and most of the trials in term neonates (five trials) reported increased stool frequencies. Role of massage therapy in the management of NNH is supported by the current evidence. However, due to limitations of the trials, current evidences are not sufficient to use massage therapy for the management of NNH in routine practice.

  2. Physical activity after commitment lotteries: examining long-term results in a cluster randomized trial.

    Science.gov (United States)

    van der Swaluw, Koen; Lambooij, Mattijs S; Mathijssen, Jolanda J P; Schipper, Maarten; Zeelenberg, Marcel; Berkhout, Stef; Polder, Johan J; Prast, Henriëtte M

    2018-02-26

    To overcome self-control difficulties, people can commit to their health goals by voluntarily accepting deadlines with consequences. In a commitment lottery, the winners are drawn from all participants, but can only claim their prize if they also attained their gym-attendance goals. In a 52-week, three-arm trial across six company gyms, we tested if commitment lotteries with behavioral economic underpinnings would promote physical activity among overweight adults. In previous work, we presented an effective 26-week intervention. In the present paper we analyzed maintenance of goal attainment at 52-week follow-up and the development of weight over time. We compared weight and goal attainment (gym attendance ≥ 2 per week) between three arms that-in the intervention period- consisted of (I) weekly short-term lotteries for 13 weeks; (II) the same short-term lotteries in combination with an additional long-term lottery after 26 weeks; and (III) a control arm without lottery-deadlines. After a successful 26-week intervention, goal attainment declined between weeks 27 and 52 in the long-term lottery arm, but remained higher than in the control group. Goal attainment did not differ between the short-term lottery arm and control arm. Weight declined slightly in all arms in the first 13 weeks of the trial and remained stable from there on. Commitment lotteries can support regular gym attendance up to 52 weeks, but more research is needed to achieve higher levels of maintenance and weight loss.

  3. Tai Chi for treating knee osteoarthritis: Designing a long-term follow up randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Rones Ramel

    2008-07-01

    Full Text Available Abstract Background Knee Osteoarthritis (KOA is a major cause of pain and functional impairment among elders. Currently, there are neither feasible preventive intervention strategies nor effective medical remedies for the management of KOA. Tai Chi, an ancient Chinese mind-body exercise that is reported to enhance muscle function, balance and flexibility, and to reduce pain, depression and anxiety, may safely and effectively be used to treat KOA. However, current evidence is inconclusive. Our study examines the effects of a 12-week Tai Chi program compared with an attention control (wellness education and stretching on pain, functional capacity, psychosocial variables, joint proprioception and health status in elderly people with KOA. The study will be completed by July 2009. Methods/Design Forty eligible patients, age > 55 yr, BMI ≤ 40 kg/m2 with tibiofemoral osteoarthritis (American College of Rheumatology criteria are identified and randomly allocated to either Tai Chi (10 modified forms from classical Yang style Tai Chi or attention control (wellness education and stretching. The 60-minute intervention sessions take place twice weekly for 12 weeks. The study is conducted at an urban tertiary medical center in Boston, Massachusetts. The primary outcome measure is the Western Ontario and McMaster Universities (WOMAC pain subscale at 12 weeks. Secondary outcomes include weekly WOMAC pain, function and stiffness scores, patient and physician global assessments, lower-extremity function, knee proprioception, depression, self-efficacy, social support, health-related quality of life, adherence and occurrence of adverse events after 12, 24 and 48 weeks. Discussion In this article, we present the challenges of designing a randomized controlled trial with long-term follow up. The challenges encountered in this design are: strategies for recruitment, avoidance of selection bias, the actual practice of Tai Chi, and the maximization of adherence

  4. A trial epidemiological study on health effects of long term and low level radiation exposure

    International Nuclear Information System (INIS)

    Hattori, Yoshiaki; Maeda, Kazuho

    1980-01-01

    As a trial evaluation of applicability of multivariate model in an analysis of health effects of radiation workers, the multiple logistic function method was applied to the data of occupational exposure record and long term absence record obtained from 593 employees of two institutions both of which practice R and D relating nuclear power. In order to estimate parameters of multiple logistic function by maximum likelihood method, followings were defined as variables: age, length of employment and cumulative exposure dose of radiation as independent variables, and the fact that whether the individual worker had the experience of absence lasting more than a week or not as a dependent variable. As the results, due to shortage of amount of data, only the age of workers shows a significant relationship with the absence data, the other variables do not have any significant results in the association with absence. In this preliminary trial, the applicability of multiple logistic function model in risk estimation of long term occupational exposure was not clearly demonstrated because of data shortage. To testify the applicability, further investigations will be needed, accumulating plenty of data concerning exposure and health effects. (author)

  5. Cerebral atrophy as outcome measure in short-term phase 2 clinical trials in multiple sclerosis

    Energy Technology Data Exchange (ETDEWEB)

    Elskamp, I.J. van den; Boden, B.; Barkhof, F. [VU University Medical Center, Department of Radiology, MS Center Amsterdam, Amsterdam (Netherlands); Dattola, V. [VU University Medical Center, Department of Radiology, MS Center Amsterdam, Amsterdam (Netherlands); University of Messina, Department of Neurosciences, Psychiatric and Anaesthesiological Sciences, Messina (Italy); Knol, D.L. [VU University Medical Center, Department of Epidemiology and Biostatistics, Amsterdam (Netherlands); Filippi, M. [Scientific Institute and University Ospedale San Raffaele, Neuroimaging Research Unit, Milan (Italy); Kappos, L. [University Hospital, University of Basel, Department of Neurology, Basel (Switzerland); Fazekas, F. [Medical University of Graz, Department of Neurology, Graz (Austria); Wagner, K. [Bayer-Schering Pharma, Berlin (Germany); Pohl, C. [Bayer-Schering Pharma, Berlin (Germany); University Hospital Bonn, Department of Neurology, Bonn (Germany); Sandbrink, R. [Bayer-Schering Pharma, Berlin (Germany); Heinrich-Heine-University Dusseldorf, Department of Neurology, Dusseldorf (Germany); Polman, C.H. [VU University Medical Center, Department of Neurology, MS Center Amsterdam, Amsterdam (Netherlands); Uitdehaag, B.M.J. [VU University Medical Center, Department of Epidemiology and Biostatistics, Amsterdam (Netherlands); VU University Medical Center, Department of Neurology, MS Center Amsterdam, Amsterdam (Netherlands)

    2010-10-15

    Cerebral atrophy is a compound measure of the neurodegenerative component of multiple sclerosis (MS) and a conceivable outcome measure for clinical trials monitoring the effect of neuroprotective agents. In this study, we evaluate the rate of cerebral atrophy in a 6-month period, investigate the predictive and explanatory value of other magnetic resonance imaging (MRI) measures in relation to cerebral atrophy, and determine sample sizes for future short-term clinical trials using cerebral atrophy as primary outcome measure. One hundred thirty-five relapsing-remitting multiple sclerosis patients underwent six monthly MRI scans from which the percentage brain volume change (PBVC) and the number and volume of gadolinium (Gd)-enhancing lesions, T2 lesions, and persistent black holes (PBH) were determined. By means of multiple linear regression analysis, the relationship between focal MRI variables and PBVC was assessed. Sample size calculations were performed for all patients and subgroups selected for enhancement or a high T2 lesion load at baseline. A significant atrophy occurred over 6 months (PBVC = -0.33%, SE = 0.061, p < 0.0001). The number of baseline T2 lesions (p = 0.024), the on-study Gd-enhancing lesion volume (p = 0.044), and the number of on-study PBHs (p = 0.003) were associated with an increased rate of atrophy. For a 50% decrease in rate of atrophy, the sample size calculations showed that approximately 283 patients per arm are required in an unselected sampled population and 185 patients per arm are required in a selected population. Within a 6-month period, significant atrophy can be detected and on-study associations of PBVC and PBHs emphasizes axonal loss to be a driving mechanism. Application as primary outcome measure in short-term clinical trials with feasible sample size requires a potent drug to obtain sufficient power. (orig.)

  6. Electroacupuncture for tapering off long-term benzodiazepine use: study protocol of randomized controlled trial.

    Science.gov (United States)

    Yeung, Wing-Fai; Chung, Ka-Fai; Zhang, Zhang-Jin; Chan, Wai-Chi; Zhang, Shi-Ping; Ng, Roger Man-Kin; Chan, Connie Lai-Wah; Ho, Lai-Ming; Yu, Yee-Man; Lao, Li-Xing

    2017-03-31

    Conventional approaches for benzodiazepine tapering have their limitations. Anecdotal studies have shown that acupuncture is a potential treatment for facilitating successful benzodiazepine tapering. As of today, there was no randomized controlled trial examining its efficacy and safety. The purpose of the study is to evaluate the efficacy of using electroacupuncture as an adjunct treatment to gradual tapering of benzodiazepine doses in complete benzodiazepine cessation in long-term benzodiazepine users. The study protocol of a randomized, assessor- and subject-blinded, controlled trial is presented. One hundred and forty-four patients with histories of using benzodiazepines in ≥50% of days for more than 3 months will be randomly assigned in a 1:1 ratio to receive either electroacupuncture or placebo electroacupuncture combined with gradual benzodiazepine tapering schedule. Both experimental and placebo treatments will be delivered twice per week for 4 weeks. Major assessments will be conducted at baseline, week 6 and week 16 post-randomization. Primary outcome is the cessation rate of benzodiazepine use. Secondary outcomes include the percentage change in the doses of benzodiazepine usage and the severity of withdrawal symptoms experienced based on the Benzodiazepine Withdrawal Symptom Questionnaire, insomnia as measured by the Insomnia Severity Index, and anxiety and depressive symptoms as evaluated by the Hospital Anxiety and Depression Scale. Adverse events will also be measured at each study visit. Results of this study will provide high quality evidence of the efficacy and safety of electroacupuncture as an adjunct treatment for benzodiazepine tapering in long-term users. ClinicalTrials.gov NCT02475538 .

  7. Breech - slideshow

    Science.gov (United States)

    ... Duplication for commercial use must be authorized in writing by ADAM Health Solutions. About MedlinePlus Site Map FAQs Customer Support Get email updates Subscribe to RSS Follow us Disclaimers Copyright ...

  8. Long-term weight-loss maintenance in obese patients with knee osteoarthritis: a randomized trial.

    Science.gov (United States)

    Christensen, Pia; Henriksen, Marius; Bartels, Else M; Leeds, Anthony R; Meinert Larsen, Thomas; Gudbergsen, Henrik; Riecke, Birgit F; Astrup, Arne; Heitmann, Berit L; Boesen, Mikael; Christensen, Robin; Bliddal, Henning

    2017-09-01

    Background: A formula low-energy diet (LED) reduces weight effectively in obese patients with knee osteoarthritis, but the role of LED in long-term weight-loss maintenance is unclear. Objective: We aimed to determine the effect of intermittent LED compared with daily meal replacements on weight-loss maintenance and number of knee replacements over 3 y. Design: The design was a randomized trial with participants aged >50 y who had knee osteoarthritis and a body mass index [BMI (in kg/m 2 )] ≥30. Participants were recruited from the osteoarthritis outpatient clinic at Copenhagen University Hospital in Frederiksberg, Denmark; they had previously completed a 68-wk lifestyle intervention trial and achieved an average weight loss of 10.5 kg (10% of initial body weight). Participants were randomly assigned to either the intermittent treatment (IN) group with LED for 5 wk every 4 mo for 3 y or to daily meal replacements of 1-2 meals for 3 y [regular (RE) group]. Attention by dietitians and the amount of formula products were similar. Primary outcomes were changes in body weight and proportion of participants receiving knee replacements. Outcomes were analyzed on the intention-to-treat-population with the use of baseline-carried-forward imputation for missing data. Results: A total of 153 participants (means ± SDs: BMI: 33.3 ± 4.6; age: 63.8 ± 6.3 y; 83% women) were recruited between June and December 2009 and randomly assigned to the IN ( n = 76) or RE ( n = 77) group. A total of 53 and 56 participants, respectively, completed the trial. Weight increased by 0.68 and 1.75 kg in the IN and RE groups, respectively (mean difference: -1.06 kg; 95% CI: -2.75, 0.63 kg; P = 0.22). Alloplasty rates were low and did not differ (IN group: 8 of 76 participants; RE group: 12 of 77 participants; P = 0.35). Conclusions: After a mean 10% weight-loss and 1-y maintenance, additional use of daily meal replacements or intermittent LED resulted in weight-loss maintenance for 3 y. These

  9. Steps to Health employee weight management randomized control trial: short-term follow-up results.

    Science.gov (United States)

    Østbye, Truls; Stroo, Marissa; Brouwer, Rebecca J N; Peterson, Bercedis L; Eisenstein, Eric L; Fuemmeler, Bernard F; Joyner, Julie; Gulley, Libby; Dement, John M

    2015-02-01

    To present the short-term follow-up findings of the Steps to Health study, a randomized trial to evaluate the effectiveness of two employee weight management programs offered within Duke University and the Health System. A total of 550 obese (body mass index, ≥30 kg/m2) employees were randomized 1:1 between January 2011 and June 2012 to the education-based Weight Management (WM) or the WM+ arm, which focused on behavior modification. Employees were contacted to complete a follow-up visit approximately 14 months after baseline. There were no clinically, or statistically, meaningful differences between arms, but there were modest reductions in body mass index, and positive, meaningful changes in diet and physical activity for both arms. The modest positive effects observed in this study may suggest that to achieve weight loss through the workplace more intensive interventions may be required.

  10. Randomized trial of plastic bags to prevent term neonatal hypothermia in a resource-poor setting.

    Science.gov (United States)

    Belsches, Theodore C; Tilly, Alyssa E; Miller, Tonya R; Kambeyanda, Rohan H; Leadford, Alicia; Manasyan, Albert; Chomba, Elwyn; Ramani, Manimaran; Ambalavanan, Namasivayam; Carlo, Waldemar A

    2013-09-01

    Term infants in resource-poor settings frequently develop hypothermia during the first hours after birth. Plastic bags or wraps are a low-cost intervention for the prevention of hypothermia in preterm and low birth weight infants that may also be effective in term infants. Our objective was to test the hypothesis that placement of term neonates in plastic bags at birth reduces hypothermia at 1 hour after birth in a resource-poor hospital. This parallel-group randomized controlled trial was conducted at University Teaching Hospital, the tertiary referral center in Zambia. Inborn neonates with both a gestational age ≥37 weeks and a birth weight ≥2500 g were randomized 1:1 to either a standard thermoregulation protocol or to a standard thermoregulation protocol with placement of the torso and lower extremities inside a plastic bag within 10 minutes after birth. The primary outcome was hypothermia (plastic bag (n = 135) or to standard thermoregulation care (n = 136) had similar baseline characteristics (birth weight, gestational age, gender, and baseline temperature). Neonates in the plastic bag group had a lower rate of hypothermia (60% vs 73%, risk ratio 0.76, confidence interval 0.60-0.96, P = .026) and a higher axillary temperature (36.4 ± 0.5°C vs 36.2 ± 0.7°C, P plastic bag at birth reduced the incidence of hypothermia at 1 hour after birth in term neonates born in a resource-poor setting, but most neonates remained hypothermic.

  11. The Erlangen Dose Optimization Trial for radiotherapy of benign painful shoulder syndrome. Long-term results

    International Nuclear Information System (INIS)

    Ott, O.J.; Hertel, S.; Gaipl, U.S.; Frey, B.; Schmidt, M.; Fietkau, R.

    2014-01-01

    To evaluate the long-term efficacy of pain reduction by two dose-fractionation schedules for radiotherapy of painful shoulder syndrome. Between February 2006 and February 2010, 312 evaluable patients were recruited for this prospective trial. All patients received low-dose orthovoltage radiotherapy. One course consisted of 6 fractions in 3 weeks. In the case of insufficient pain remission after 6 weeks, a second course was administered. Patients were randomly assigned to one of two groups to receive single doses of either 0.5 or 1.0 Gy. Endpoint was pain reduction. Pain was measured before radiotherapy, as well as immediately after (early response), 6 weeks after (delayed response) and approximately 3 years after (long-term response) completion of radiotherapy using a questionnaire-based visual analogue scale (VAS) and a comprehensive pain score (CPS). Median follow-up was 35 months (range 11-57). The overall early, delayed and long-term response rates for all patients were 83, 85 and 82%, respectively. The mean VAS scores before treatment and those for early, delayed and long-term response in the 0.5- and 1.0-Gy groups were 56.8±23.7 and 53.2±21.8 (p=0.16); 38.2±36.1 and 34.0±24.5 (p=0.19); 33.0±27.2 and 23.7±22.7 (p=0.04) and 27.9±25.8 and 32.1±26.9 (p=0.25), respectively. The mean CPS values before treatment and those for early, delayed and long-term response were 9.7±3.0 and 9.5±2.7 (p=0.31); 6.1±3.6 and 5.4±3.6 (p=0.10); 5.3±3.7 and 4.1±3.7 (p=0.05) and 4.0±3.9 and 5.3±4.4 (p=0.05), respectively. No significant differences in the quality of the long-term response were found between the 0.5- and 1.0-Gy arms (p=0.28). Radiotherapy is an effective treatment for the management of benign painful shoulder syndrome. For radiation protection reasons, the dose for a radiotherapy series should not exceed 3.0 Gy. (orig.)

  12. Implementation of client versus care-provider strategies to improve external cephalic version rates: a cluster randomized controlled trial

    NARCIS (Netherlands)

    Vlemmix, Floortje; Rosman, Ageeth N.; Rijnders, Marlies E.; Beuckens, Antje; Opmeer, Brent C.; Mol, Ben W. J.; Kok, Marjolein; Fleuren, Margot A. H.

    2015-01-01

    To determine the effectiveness of a client or care-provider strategy to improve the implementation of external cephalic version. Cluster randomized controlled trial. Twenty-five clusters; hospitals and their referring midwifery practices randomly selected in the Netherlands. Singleton breech

  13. Foley Catheter for Induction of Labor at Term: An Open-Label, Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Ning Gu

    Full Text Available This study aimed to determine the optimal Foley catheter balloon volume (30-mL vs. 80-mL and the maximum time for cervical ripening (12 hours vs. 24 hours to improve vaginal delivery rate within 24 hours of induction.We conducted an open-label, randomized controlled trial in a teaching hospital in China. Women with a term singleton pregnancy, cephalic presentation, intact membrane and an unfavorable cervix (Bishop score <6 were randomly allocated, in 1:1:1:1 ratio, to receive either one of the four treatments: (1 30-mL balloon for a maximum of 12 hours, (2 30-mL balloon for a maximum of 24 hours, (3 80-mL balloon for a maximum of 12 hours, and (4 80-mL balloon for a maximum of 24 hours. The primary outcome was vaginal delivery within 24 hours. Secondary outcomes included cesarean section rate and maternal/neonatal morbidity. Data were analyzed on a per-protocol basis.Five hundred and four women were recruited and randomized (126 women in each group; nine women did not receive the assigned intervention. More women achieved vaginal delivery within 24 hours in 12-hour Foley catheter groups than in the 24-hour Foley catheter groups (30-mL/12 hours: 54.5%, 30-mL/24 hours: 33.1%, 80-mL/12 hours: 46.4%, 80-mL/24 hours: 24.0%, p < 0.001. Cesarean section rates and the incidence of chorioaminonitis were comparable among four groups. After adjustment for confounding factors, both ripening time and balloon size did not affect the proportion of women delivered vaginally within 24 hours of induction.For women with an unfavorable cervix at term, induction of labor with a Foley catheter is safe and effective. Higher balloon volume (80-mL vs. 30-mL and longer ripening time (24 hours vs. 12 hours would not shorten induction to delivery interval or reduce cesarean section rate.Chinese Clinical trial registry (ChiCTR-TRC-13003044.

  14. Long-term outcome in term breech infants with low Apgar score--a population-based follow-up

    DEFF Research Database (Denmark)

    Krebs, L; Langhoff-Roos, J; Thorngren-Jerneck, K

    2001-01-01

    and 218 controls. RESULTS: Four cases (4.6%) and one control (0.5%) had cerebral palsy. In infants without cerebral palsy, speech/language problems were more frequent than controls (10.6 versus 3.2%) (P=0.02). There were no differences in rates of deficits in attention, motor control and perception (DAMP...

  15. 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.

  16. Dutch iliac stent trial : Long-term results in patients randomized for primary or selective stent placement

    NARCIS (Netherlands)

    Klein, W.M.; van der Graaf, Y.; Seegers, J.; Spithoven, J.H.; Buskens, E.; van Baal, J.G.; Buth, J.; Moll, F.L.; Overtoom, T.T.C.; van Sambeek, M.R.H.M.; Mali, W.P.T.M.

    Purpose: To determine long-term results of the prospective Dutch Iliac Stent Trial. Materials and Methods: The study protocol was approved by local institutional review boards. All patients gave written informed consent. Two hundred seventy-nine patients (201 men, 78 women; mean age, 58 years) with

  17. Long-term sequential deferiprone-deferoxamine versus deferiprone alone for thalassaemia major patients: a randomized clinical trial

    DEFF Research Database (Denmark)

    Maggio, Aurelio; Vitrano, Angela; Capra, Marcello

    2009-01-01

    A multicentre randomized open-label trial was designed to assess the effectiveness of long-term sequential deferiprone-deferoxamine (DFO-DFP) versus DFP alone to treat thalassaemia major (TM). DFP at 75 mg/kg, divided into three oral daily doses, for 4 d/week and DFO by subcutaneous infusion (8-1...

  18. Fracture of the Femur of A Newborn after Cesarean Section for Breech Presentation and Fibroid Uterus :A Case Report and Literature Review

    Directory of Open Access Journals (Sweden)

    Ibrahima Farikou

    2014-01-01

    Full Text Available Introduction: The practice of cesarean section is known to decrease the occurrence of long bone fractures. We present here an unusual diaphyseal fracture of the femur of a newborn after cesarean section, the only case observed in our 14 years of practice. Case Report: The patient was a 3.4-kg female child born at 38 weeks of gestation. The mother was a primipara and aged 39 years. Ultrasound examination at 20th week revealed intrauterine fibroids with a breech presentation. Therefore, elective cesarean section was indicated. There was no apparent bone disorder that could predispose to sustain femur fracture. The fracture was treated successfully with a bilateral spica cast. The cesarean section was indicated in an aged primipara, bearer of uterine fibroids, and breech presentation. She had a good general health status, but her bone density was unknown since this examination is not routinely performed in our clinical settings in Africa. Conclusion: Elderly age, primipara status, presence of uterine fibroids, and breech presentation are usual indications for cesarean section. However, there are not many reports on femur fracture after cesarean section. Our present case suggests that despite the latest advances in delivery techniques, cesarean section for breech presentation predisposes the neonate to femoral fractures. Keywords: Femur fracture; Cesarean section; Fibroid; Breech presentation; Africa.

  19. Effect of Probiotics on Serum Bilirubin Level in Term Neonates with Jaundice; A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Yadollah Zahed Pasha

    2017-10-01

    Full Text Available Background In recent years, tendency to use drugs has been increasing in the treatment of neonatal jaundice. Several drugs have been used since then, but the effect of probiotics on serum bilirubin level (SBL is not so clear. This study was conducted to evaluate the effect of probiotics on SBL and the duration of phototherapy in term neonates with hyperbilirubinemia. Materials and Methods: In this randomized clinical trial, we studied 150 term neonate with jaundice hospitalized for phototherapy in Amirkola Children’s Hospital, Babol- Iran, during October 5, 2016 till May 19, 2017. Eligible neonates were randomly divided into two; intervention (n=75, and control (n=75 groups. Both groups received standard conventional phototherapy, but the intervention group received 10 drop/day of probiotics (Pedilact Zisttakhmir. Co. Iran, until hospital discharge. The outcome variables were SBL and the duration of phototherapy. The data was analyzed by SPSS 22.0 and   the P 0.05.After 24, 48 and 72hours it decreased to 13.73±1.72, 10.92±1.87 and 10.25±1.32 in the intervention and 13.66±1.91, 11.01±1.69 and10.09 ±1.38 in the control groups, respectively but comparison of the amount of SBL reduction  between the two groups was not significant (P>0.05. The duration of phototherapy in the intervention group and the control group was 3.61±1.17 days and 3.72±1.18 days respectively (P>0.05. Conclusion Oral probiotics in neonates with jaundice has no significant effect on SBL and the duration of phototherapy. Further studies are needed to with longer time follow-up.

  20. Regulatory Technology Development Plan - Sodium Fast Reactor. Mechanistic Source Term - Trial Calculation. Work Plan

    International Nuclear Information System (INIS)

    Grabaskas, David; Bucknor, Matthew; Jerden, James; Brunett, Acacia J.

    2016-01-01

    The overall objective of the SFR Regulatory Technology Development Plan (RTDP) effort is to identify and address potential impediments to the SFR regulatory licensing process. In FY14, an analysis by Argonne identified the development of an SFR-specific MST methodology as an existing licensing gap with high regulatory importance and a potentially long lead-time to closure. This work was followed by an initial examination of the current state-of-knowledge regarding SFR source term development (ANLART-3), which reported several potential gaps. Among these were the potential inadequacies of current computational tools to properly model and assess the transport and retention of radionuclides during a metal fuel pool-type SFR core damage incident. The objective of the current work is to determine the adequacy of existing computational tools, and the associated knowledge database, for the calculation of an SFR MST. To accomplish this task, a trial MST calculation will be performed using available computational tools to establish their limitations with regard to relevant radionuclide release/retention/transport phenomena. The application of existing modeling tools will provide a definitive test to assess their suitability for an SFR MST calculation, while also identifying potential gaps in the current knowledge base and providing insight into open issues regarding regulatory criteria/requirements. The findings of this analysis will assist in determining future research and development needs.

  1. Long-term follow-up of children with high-risk neuroblastoma: the ENSG5 trial experience.

    Science.gov (United States)

    Moreno, Lucas; Vaidya, Sucheta J; Pinkerton, C Ross; Lewis, Ian J; Imeson, John; Machin, David; Pearson, Andrew D J

    2013-07-01

    Therapy for high-risk neuroblastoma is intensive and multimodal, and significant long-term adverse effects have been described. The aim of this study was to identify the nature and severity of late complications of metastatic neuroblastoma survivors included in the ENSG5 clinical trial. The trial protocol included induction chemotherapy (randomized "Standard" OPEC/OJEC vs. "Rapid" COJEC), surgery of primary tumor and high-dose melphalan with stem cell rescue. Two hundred and sixty-two children were randomized, 69 survived >5 years, and 57 were analyzed. Data were obtained from the ENSG5 trial database and verified with questionnaires sent to participating centers. Median follow-up was 12.9 (6.9-16.5) years. No differences were found in late toxicities between treatment arms. Twenty-eight children (49.1%) developed hearing loss. Nine patients (15.8%) developed glomerular filtration rate <80 ml/min/1.73 m(2), but no cases of chronic renal failure were documented. Endocrine complications (28.1% of children) included mainly hypogonadism and delayed growth. Four children developed second malignancies, three of them 5 years after diagnosis: one osteosarcoma, one carcinoma of the parotid gland and one ependymoma. There were no hematological malignancies or deaths in remission. This study analyzed a wide cohort of high-risk neuroblastoma survivors from a multi-institutional randomized trial and established the profile of long-term toxicity within the setting of an international clinical trial. Copyright © 2012 Wiley Periodicals, Inc.

  2. Congenital high airway obstruction syndrome in the breech presentation managed by ex utero intrapartum treatment procedure after intraoperative external cephalic version.

    Science.gov (United States)

    Miwa, Ichiro; Sase, Masakatsu; Nakamura, Yasuhiko; Hasegawa, Keiko; Kawasaki, Masahiro; Ueda, Kazuyuki

    2012-05-01

    Congenital high airway obstruction syndrome (CHAOS) caused by laryngeal atresia was diagnosed by prenatal ultrasound in a male fetus at 26 weeks of gestation. Findings included massive ascites, subcutaneous edema, enlarged hyperechogenic lungs with diaphragmatic inversion, dilated trachea, polyhydramnios, and breech presentation. Those findings of CHAOS spontaneously returned to normal by 33 weeks of gestation. However, the placenta was localized to the anterior uterine wall. In addition, the fetal position had been breech until delivery. At 36 weeks of gestation, a planned ex utero intrapartum treatment (EXIT) procedure was performed following intraoperative external cephalic version (ECV) in which the fetus was approached from the posterior wall of the uterus. Laryngoscopy revealed the predicted laryngeal obstruction, and tracheostomy was placed. Intraoperative ECV may be a useful technique in breech presentation before EXIT procedure. © 2012 The Authors. Journal of Obstetrics and Gynaecology Research © 2012 Japan Society of Obstetrics and Gynecology.

  3. [Breech presentation: mode of delivery and maternal and fetal outcomes at the Ignace Deen Clinic of Gynecology and Obstetrics, Conakry University Hospital].

    Science.gov (United States)

    Sy, T; Diallo, Y; Diallo, A; Soumah, A; Diallo, F B; Hyjazi, Y; Diallo, M S

    2011-01-01

    The authors in a prospective, analytical study of 8 months from January 1st to August 31st performed at the Ignace Deen Clinic of Gynecology and Obstetrics, Conakry University Hospital; assessed the impact of the mode of delivery in breech presentation on maternal and fetal outcome in the African context of Guinea. Breech presentation in mono fetal pregnancy of at least 28 weeks of amenorrhea was the inclusion criterion in this study. Among 1490 deliveries, 144 breech presentations were reviewed, representing a frequency of 9.66%. Half of breech deliveries (49.99%) were premature against only 11.85% in cephalic presentations. The breech was incomplete in 57.64% cases and complete in 42.35%. Caesarean section was performed in 40.97% of cases against 39.54% in cephalic presentation. The indications were often primiparity (30.50%), acute fetal distress (28.81%) and macrosomia (23.72%). Deliveries through the lower route frequently used the maneuver of Bracht (52.50%). 54.16% of the new-born babies had a fetal weight lower than 2500 g at born. Morbid Apgar score at the 1st minute after delivery through the lower route was found in 69.40% of the breech presentation born babies; however, this rate was 32.70% in cephalic presentation (p=0.000). The maternal morbidity concerned essentially perineal lesions (26.53%). The outcome is largely better in case of delivery through the upper route. The caesarean section is an alternative for the improvement of fetal outcome in countries with low resources.

  4. Long-Term Improvements After Multimodal Rehabilitation in Late Phase After Stroke: A Randomized Controlled Trial.

    Science.gov (United States)

    Bunketorp-Käll, Lina; Lundgren-Nilsson, Åsa; Samuelsson, Hans; Pekny, Tulen; Blomvé, Karin; Pekna, Marcela; Pekny, Milos; Blomstrand, Christian; Nilsson, Michael

    2017-07-01

    Treatments that improve function in late phase after stroke are urgently needed. We assessed whether multimodal interventions based on rhythm-and-music therapy or horse-riding therapy could lead to increased perceived recovery and functional improvement in a mixed population of individuals in late phase after stroke. Participants were assigned to rhythm-and-music therapy, horse-riding therapy, or control using concealed randomization, stratified with respect to sex and stroke laterality. Therapy was given twice a week for 12 weeks. The primary outcome was change in participants' perception of stroke recovery as assessed by the Stroke Impact Scale with an intention-to-treat analysis. Secondary objective outcome measures were changes in balance, gait, grip strength, and cognition. Blinded assessments were performed at baseline, postintervention, and at 3- and 6-month follow-up. One hundred twenty-three participants were assigned to rhythm-and-music therapy (n=41), horse-riding therapy (n=41), or control (n=41). Post-intervention, the perception of stroke recovery (mean change from baseline on a scale ranging from 1 to 100) was higher among rhythm-and-music therapy (5.2 [95% confidence interval, 0.79-9.61]) and horse-riding therapy participants (9.8 [95% confidence interval, 6.00-13.66]), compared with controls (-0.5 [-3.20 to 2.28]); P =0.001 (1-way ANOVA). The improvements were sustained in both intervention groups 6 months later, and corresponding gains were observed for the secondary outcomes. Multimodal interventions can improve long-term perception of recovery, as well as balance, gait, grip strength, and working memory in a mixed population of individuals in late phase after stroke. URL: http//www.ClinicalTrials.gov. Unique identifier: NCT01372059. © 2017 American Heart Association, Inc.

  5. Long-term Bias of Internal Markers in Sheep and Goat Digestion Trials

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    Gleidson Giordano Pinto de Carvalho

    2013-01-01

    Full Text Available Two digestion trials, one with sheep and another with goats, were conducted to evaluate the long-term bias (LTB of the indigestible dry matter (iDM, indigestible neutral detergent fiber (iNDF and indigestible acid detergent fiber (iADF internal markers. The study used eight Santa Inês castrated male sheep (average body weight of 16.6 kg distributed in two 4×4 Latin squares and eight Saanen castrated male goats (average body weight of 22.6 kg distributed in two 4×4 Latin squares. The experiments were conducted simultaneously, and the animals were housed in 1.2 m2 individual pens with wood-battened floors equipped with individual feeders and drinkers. The animals received isonitrogenous diets that were offered ad libitum and contained 14% crude protein and 70% sugar cane (with 0, 0.75, 1.5 or 2.25% CaO, in natural matter percentage, corrected with 1% urea and 30% concentrate. The experiment consisted of four experimental periods of 14 d each, with the feed, leftovers and feces sampled on the last four days of each period. The marker concentrations in the feed, leftovers and fecal samples were estimated by an in situ ruminal incubation procedure with a duration 240 h. The relationship between the intake and excretion of the markers was obtained by adjusting a simple linear regression model, independently from the treatment (diets fixed effects and Latin squares. For both the sheep and goats, a complete recovery of the iDM and iNDF markers was observed (p>0.05, indicating the absence of LTB for these markers. However, the iADF was not completely recovered, exhibiting an LTB of −9.12% (p<0.05 in the sheep evaluation and −3.02% (p<0.05 in the goat evaluation.

  6. Human papillomavirus-based cervical cancer prevention: long-term results of a randomized screening trial.

    Science.gov (United States)

    Denny, Lynette; Kuhn, Louise; Hu, Chih-Chi; Tsai, Wei-Yann; Wright, Thomas C

    2010-10-20

    Screen-and-treat approaches to cervical cancer prevention are an attractive option for low-resource settings, but data on their long-term efficacy are lacking. We evaluated the efficacy of two screen-and-treat approaches through 36 months of follow-up in a randomized trial. A total of 6637 unscreened South African women aged 35-65 years who were tested for the presence of high-risk human papillomavirus (HPV) DNA in cervical samples underwent visual inspection of the cervix using acetic acid staining and HIV serotesting. Of these, 6555 were randomly assigned to three study arms: 1) HPV-and-treat, in which all women with a positive HPV DNA test result underwent cryotherapy; 2) visual inspection-and-treat, in which all women with a positive visual inspection test result underwent cryotherapy; or 3) control, in which further evaluation or treatment was delayed for 6 months. All women underwent colposcopy with biopsy at 6 months. All women who were HPV DNA- or visual inspection-positive at enrollment, and a subset of all other women had extended follow-up to 36 months (n = 3639) with yearly colposcopy. The endpoint-cervical intraepithelial neoplasia grade 2 or worse (CIN2+)-was analyzed using actuarial life-table methods. All statistical tests were two-sided. After 36 months, there was a sustained statistically significant decrease in the cumulative detection of CIN2+ in the HPV-and-treat arm compared with the control arm (1.5% vs 5.6%, difference = 4.1%, 95% confidence interval [CI] = 2.8% to 5.3%, P cryotherapy.

  7. Long-term results from the Contura multilumen balloon breast brachytherapy catheter phase 4 registry trial.

    Science.gov (United States)

    Cuttino, Laurie W; Arthur, Douglas W; Vicini, Frank; Todor, Dorin; Julian, Thomas; Mukhopadhyay, Nitai

    2014-12-01

    To describe the long-term outcomes from a completed, multi-institutional phase 4 registry trial using the Contura multilumen balloon (CMLB) breast brachytherapy catheter to deliver accelerated partial breast irradiation (APBI) in patients with early-stage breast cancer. Three hundred forty-two evaluable patients were enrolled by 23 institutions between January 2008 and February 2011. All patients received 34 Gy in 10 fractions, delivered twice daily. Rigorous target coverage and normal tissue dose constraints were observed. The median follow-up time was 36 months (range, 1-54 months). For the entire patient cohort of 342 patients, 10 patients experienced an ipsilateral breast tumor recurrence (IBTR). Eight of these IBTR were classified as true recurrences/marginal miss (TRMM), and 2 were elsewhere failures (EF). Local recurrence-free survival was 97.8% at 3 years. For the entire cohort, 88% of patients had good to excellent overall cosmesis. The overall incidence of infection was 8.5%. Symptomatic seroma was reported in only 4.4% of patients. A separate analysis was performed to determine whether improved outcomes would be observed for patients treated at high-volume centers with extensive brachytherapy experience. Three IBTR were observed in this cohort, only 1 of which was classified as a TRMM. Local recurrence-free survival at high-volume centers was 98.1% at 3 years. Overall cosmetic outcome and toxicity were superior in patients treated at high-volume centers. In these patients, 95% had good to excellent overall cosmesis. Infection was observed in only 2.9% of patients, and symptomatic seroma was reported in only 1.9%. Use of the CMLB for APBI delivery is associated with acceptable long-term local control and toxicity. Local recurrence-free survival was 97.8% at 3 years. Significant (grade 3) toxicity was uncommon, and no grade 4 toxicity was observed. Treatment at high-volume centers was associated with decreased late toxicity. Copyright © 2014 Elsevier Inc

  8. Long-Term Results From the Contura Multilumen Balloon Breast Brachytherapy Catheter Phase 4 Registry Trial

    Energy Technology Data Exchange (ETDEWEB)

    Cuttino, Laurie W., E-mail: lcuttino@mcvh-vcu.edu [Department of Radiation Oncology, Virginia Commonwealth University, Richmond, Virginia (United States); Arthur, Douglas W. [Department of Radiation Oncology, Virginia Commonwealth University, Richmond, Virginia (United States); Vicini, Frank [Michigan Healthcare Professionals/21st Century Onoclogy, Farmington Hills, Michigan (United States); Todor, Dorin [Department of Radiation Oncology, Virginia Commonwealth University, Richmond, Virginia (United States); Julian, Thomas [Allegheny Hospital, Temple School of Medicine, Pittsburgh, Pennsylvania (United States); Mukhopadhyay, Nitai [Department of Radiation Oncology, Virginia Commonwealth University, Richmond, Virginia (United States)

    2014-12-01

    Purpose: To describe the long-term outcomes from a completed, multi-institutional phase 4 registry trial using the Contura multilumen balloon (CMLB) breast brachytherapy catheter to deliver accelerated partial breast irradiation (APBI) in patients with early-stage breast cancer. Methods and Materials: Three hundred forty-two evaluable patients were enrolled by 23 institutions between January 2008 and February 2011. All patients received 34 Gy in 10 fractions, delivered twice daily. Rigorous target coverage and normal tissue dose constraints were observed. Results: The median follow-up time was 36 months (range, 1-54 months). For the entire patient cohort of 342 patients, 10 patients experienced an ipsilateral breast tumor recurrence (IBTR). Eight of these IBTR were classified as true recurrences/marginal miss (TRMM), and 2 were elsewhere failures (EF). Local recurrence-free survival was 97.8% at 3 years. For the entire cohort, 88% of patients had good to excellent overall cosmesis. The overall incidence of infection was 8.5%. Symptomatic seroma was reported in only 4.4% of patients. A separate analysis was performed to determine whether improved outcomes would be observed for patients treated at high-volume centers with extensive brachytherapy experience. Three IBTR were observed in this cohort, only 1 of which was classified as a TRMM. Local recurrence-free survival at high-volume centers was 98.1% at 3 years. Overall cosmetic outcome and toxicity were superior in patients treated at high-volume centers. In these patients, 95% had good to excellent overall cosmesis. Infection was observed in only 2.9% of patients, and symptomatic seroma was reported in only 1.9%. Conclusion: Use of the CMLB for APBI delivery is associated with acceptable long-term local control and toxicity. Local recurrence-free survival was 97.8% at 3 years. Significant (grade 3) toxicity was uncommon, and no grade 4 toxicity was observed. Treatment at high-volume centers was associated

  9. Factors affecting the success of moxibustion in the management of a breech presentation as a preliminary treatment to external cephalic version.

    Science.gov (United States)

    Manyande, Anne; Grabowska, Christine

    2009-12-01

    to explore the effects of moxibustion treatment, to examine the predictors of its use in causing a breech presentation to spontaneously turn to a cephalic presentation which will result in a vaginal birth (the paper will refer to this as 'successful') and offer external cephalic version (ECV) subsequently after moxibustion treatment when the fetus remains in a breech presentation. a prospective study over a two-year time period from February 2004 until January 2006. 76 pregnant women from various acupuncture practices in the UK, with a third trimester breech presentation. the acupuncturist taught the women how to apply moxibustion (sticks of compressed dried herbs-Artemisia vulgaris) treatment at home by stimulating the acupoint on the outer edge at the base of the little toe nail for seven days twice a day (morning and afternoon). If the breech presentation persisted after treatment, ECV was carried out towards the end of the pregnancy. The obstetricians offered this during the routine antenatal hospital visits. the results show that following treatment with moxibustion, 31 (40.8%) of the breech presentations spontaneously turned to cephalic presentations, and a further 33 (43.4%) breech presentations were turned by ECV. Women who involved other people in the administration of moxibustion were twice as likely to be successful. Multiparous women were also 16% more likely than primiparous women to succeed in achieving a spontaneous version with the use of moxibustion. Fewer side effects reported when using moxibustion were the strongest predictor of successful spontaneous cephalic version with an odds ratio of 12% (p = 0.02). moxibustion creates a better chance of vaginal birth for expectant mothers. Of the women who were successful in turning their babies using moxibustion, 88% went on to have a normal birth and 12% had a caesarean section. Moxibustion treatment also significantly increases version from a breech presentation to a cephalic presentation where there

  10. Non-inferiority of short-term urethral catheterization following fistula repair surgery: study protocol for a randomized controlled trial

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    Barone Mark A

    2012-03-01

    Full Text Available Abstract Background A vaginal fistula is a devastating condition, affecting an estimated 2 million girls and women across Africa and Asia. There are numerous challenges associated with providing fistula repair services in developing countries, including limited availability of operating rooms, equipment, surgeons with specialized skills, and funding from local or international donors to support surgeries and subsequent post-operative care. Finding ways of providing services in a more efficient and cost-effective manner, without compromising surgical outcomes and the overall health of the patient, is paramount. Shortening the duration of urethral catheterization following fistula repair surgery would increase treatment capacity, lower costs of services, and potentially lower risk of healthcare-associated infections among fistula patients. There is a lack of empirical evidence supporting any particular length of time for urethral catheterization following fistula repair surgery. This study will examine whether short-term (7 day urethral catheterization is not worse by more than a minimal relevant difference to longer-term (14 day urethral catheterization in terms of incidence of fistula repair breakdown among women with simple fistula presenting at study sites for fistula repair service. Methods/Design This study is a facility-based, multicenter, non-inferiority randomized controlled trial (RCT comparing the new proposed short-term (7 day urethral catheterization to longer-term (14 day urethral catheterization in terms of predicting fistula repair breakdown. The primary outcome is fistula repair breakdown up to three months following fistula repair surgery as assessed by a urinary dye test. Secondary outcomes will include repair breakdown one week following catheter removal, intermittent catheterization due to urinary retention and the occurrence of septic or febrile episodes, prolonged hospitalization for medical reasons, catheter blockage, and

  11. Radiotherapy for benign achillodynia. Long-term results of the Erlangen Dose Optimization Trial

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    Ott, Oliver J.; Jeremias, Carolin; Gaipl, Udo S.; Frey, Benjamin; Schmidt, Manfred; Fietkau, Rainer [University Hospital Erlangen, Department of Radiation Oncology, Erlangen (Germany)

    2015-12-15

    The aim of this study was to evaluate the long-term efficacy of two dose-fractionation schedules for radiotherapy of achillodynia. Between February 2006 and February 2010, 112 evaluable patients were recruited for this prospective trial. All patients received orthovoltage radiotherapy. One course consisted of 6 fractions/3 weeks. In the case of insufficient remission of pain after 6 weeks, a second series was performed. Patients were randomly assigned to receive either single doses of 0.5 or 1.0 Gy. The endpoint was pain reduction. Pain was measured before, right after (early response), 6 weeks after (delayed response), and approximately 2 years after radiotherapy (long-term response) with a questionnaire-based visual analogue scale (VAS) and a comprehensive pain score (CPS). The median follow-up was 24 months (range, 11-56). The overall early, delayed, and long-term response rates for all patients were 84 %, 88 %, and 95 %, respectively. The mean VAS values before treatment for early, delayed, and long-term responses for the 0.5-Gy and 1.0-Gy groups were 55.7 ± 21.0 and 58.2 ± 23.5 (p = 0.53), 38.0 ± 23.2 and 30.4 ± 22.6 (p = 0.08), 35.5 ± 25.9 and 30.9 ± 25.4 (p = 0.52), and 11.2 ± 16.4 and 15.3 ± 18.9 (p = 0.16), respectively. The mean CPS values before treatment for early, delayed, and long-term responses were 8.2 ± 3.0 and 8.9 ± 3.3 (p = 0.24), 5.6 ± 3.1 and 5.4 ± 3.3 (p = 0.76), 4.4 ± 2.6 and 5.3 ± 3.8 (p = 0.58), and 2.2 ± 2.9 and 2.8 ± 3.3 (p = 0.51), respectively. No significant differences in long-term response quality between the two arms was found (p = 0.73). Radiotherapy is a very effective treatment for the management of benign achillodynia. For radiation protection, the dose for a radiotherapy series should not exceed 3.0 Gy. (orig.) [German] Ziel war die Untersuchung der Langzeiteffektivitaet zweier Dosisfraktionierungskonzepte bei der Strahlentherapie von Patienten mit Achillodynie. Zwischen 2006 und 2010 wurden 112 auswertbare

  12. Achieving definitive results in long-chain polyunsaturated fatty acid supplementation trials of term infants: factors for consideration.

    Science.gov (United States)

    Meldrum, Suzanne J; Smith, Michael A; Prescott, Susan L; Hird, Kathryn; Simmer, Karen

    2011-04-01

    Numerous randomized controlled trials (RCTs) have been undertaken to determine whether supplementation with long-chain polyunsaturated fatty acids (LCPUFAs) in infancy would improve the developmental outcomes of term infants. The results of such trials have been thoroughly reviewed with no definitive conclusion as to the efficacy of LCPUFA supplementation. A number of reasons for the lack of conclusive findings in this area have been proposed. This review examines such factors with the aim of determining whether an optimal method of investigation for RCTs of LCPUFA supplementation in term infants can be ascertained from previous research. While more research is required to completely inform a method that is likely to achieve definitive results, the findings of this literature review indicate future trials should investigate the effects of sex, genetic polymorphisms, the specific effects of LCPUFAs, and the optimal tests for neurodevelopmental assessment. The current literature indicates a docosahexaenoic acid dose of 0.32%, supplementation from birth to 12 months, and a total sample size of at least 286 (143 per group) should be included in the methodology of future trials. © 2011 International Life Sciences Institute.

  13. Evaluation of Short-Term Changes in Serum Creatinine Level as a Meaningful End Point in Randomized Clinical Trials.

    Science.gov (United States)

    Coca, Steven G; Zabetian, Azadeh; Ferket, Bart S; Zhou, Jing; Testani, Jeffrey M; Garg, Amit X; Parikh, Chirag R

    2016-08-01

    Observational studies have shown that acute change in kidney function (specifically, AKI) is a strong risk factor for poor outcomes. Thus, the outcome of acute change in serum creatinine level, regardless of underlying biology or etiology, is frequently used in clinical trials as both efficacy and safety end points. We performed a meta-analysis of clinical trials to quantify the relationship between positive or negative short-term effects of interventions on change in serum creatinine level and more meaningful clinical outcomes. After a thorough literature search, we included 14 randomized trials of interventions that altered risk for an acute increase in serum creatinine level and had reported between-group differences in CKD and/or mortality rate ≥3 months after randomization. Seven trials assessed interventions that, compared with placebo, increased risk of acute elevation in serum creatinine level (pooled relative risk, 1.52; 95% confidence interval, 1.22 to 1.89), and seven trials assessed interventions that, compared with placebo, reduced risk of acute elevation in serum creatinine level (pooled relative risk, 0.57; 95% confidence interval, 0.44 to 0.74). However, pooled risks for CKD and mortality associated with interventions did not differ from those with placebo in either group. In conclusion, several interventions that affect risk of acute, mild to moderate, often temporary elevation in serum creatinine level in placebo-controlled randomized trials showed no appreciable effect on CKD or mortality months later, raising questions about the value of using small to moderate changes in serum creatinine level as end points in clinical trials. Copyright © 2016 by the American Society of Nephrology.

  14. Immunoglobulins in Neonates with Rhesus Hemolytic Disease of the Fetus and Newborn: Long-Term Outcome in a Randomized Trial.

    Science.gov (United States)

    van Klink, Jeanine M M; van Veen, Suzanne J; Smits-Wintjens, Vivianne E H J; Lindenburg, Irene T M; Rijken, Monique; Oepkes, Dick; Lopriore, Enrico

    2016-01-01

    Prophylactic intravenous immunoglobulin (IVIg) does neither reduce the need for exchange transfusion nor the rates of other adverse neonatal outcomes in neonates with rhesus hemolytic disease of the fetus and newborn (rhesus HDFN) according to our randomized controlled trial analysis. Our objective was to assess the long-term neurodevelopmental outcome in the children included in the trial and treated with either IVIg or placebo. All families of the children included in the trial were asked to participate in this follow-up study. The long-term neurodevelopmental outcome in children at least 2 years of age was assessed using standardized tests. The primary outcome was the incidence of neurodevelopmental impairment defined as at least one of the following: cerebral palsy, severe cognitive and/or motor developmental delay (with a test score of less than -2 SD), bilateral deafness or blindness. Sixty-six of the 80 children (82.5%) who had been recruited to the initial randomized controlled trial participated in the follow-up study. The children were assessed at a median age of 4 years (range 2-7). The median cognitive score was 96 (range 68-118) in the IVIg group and 97 (range 66-118) in the placebo group (p = 0.79). There was no difference in the rate of neurodevelopmental impairment between the IVIg and the placebo group [3% (1/34) vs. 3% (1/32); p = 1.00]. The long-term neurodevelopmental outcome in children treated with IVIg was not different from that in children treated with placebo. Standardized long-term follow-up studies with large enough case series and sufficient power are needed to replicate these findings. © 2015 S. Karger AG, Basel.

  15. Long-Term Collaboration Network Based on ClinicalTrials.gov Database in the Pharmaceutical Industry

    Directory of Open Access Journals (Sweden)

    Heyoung Yang

    2018-01-01

    Full Text Available Increasing costs, risks, and productivity problems in the pharmaceutical industry are important recent issues in the biomedical field. Open innovation is proposed as a solution to these issues. However, little statistical analysis related to collaboration in the pharmaceutical industry has been conducted so far. Meanwhile, not many cases have analyzed the clinical trials database, even though it is the information source with the widest coverage for the pharmaceutical industry. The purpose of this study is to test the clinical trials information as a probe for observing the status of the collaboration network and open innovation in the pharmaceutical industry. This study applied the social network analysis method to clinical trials data from 1980 to 2016 in ClinicalTrials.gov. Data were divided into four time periods—1980s, 1990s, 2000s, and 2010s—and the collaboration network was constructed for each time period. The characteristic of each network was investigated. The types of agencies participating in the clinical trials were classified as a university, national institute, company, or other, and the major players in the collaboration networks were identified. This study showed some phenomena related to the pharmaceutical industry that could provide clues to policymakers about open innovation. If follow-up studies were conducted, the utilization of the clinical trial database could be further expanded, which is expected to help open innovation in the pharmaceutical industry.

  16. A novel method to adjust efficacy estimates for uptake of other active treatments in long-term clinical trials.

    Directory of Open Access Journals (Sweden)

    John Simes

    2010-01-01

    Full Text Available When rates of uptake of other drugs differ between treatment arms in long-term trials, the true benefit or harm of the treatment may be underestimated. Methods to allow for such contamination have often been limited by failing to preserve the randomization comparisons. In the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD study, patients were randomized to fenofibrate or placebo, but during the trial many started additional drugs, particularly statins, more so in the placebo group. The effects of fenofibrate estimated by intention-to-treat were likely to have been attenuated. We aimed to quantify this effect and to develop a method for use in other long-term trials.We applied efficacies of statins and other cardiovascular drugs from meta-analyses of randomized trials to adjust the effect of fenofibrate in a penalized Cox model. We assumed that future cardiovascular disease events were reduced by an average of 24% by statins, and 20% by a first other major cardiovascular drug. We applied these estimates to each patient who took these drugs for the period they were on them. We also adjusted the analysis by the rate of discontinuing fenofibrate. Among 4,900 placebo patients, average statin use was 16% over five years. Among 4,895 assigned fenofibrate, statin use was 8% and nonuse of fenofibrate was 10%. In placebo patients, use of cardiovascular drugs was 1% to 3% higher. Before adjustment, fenofibrate was associated with an 11% reduction in coronary events (coronary heart disease death or myocardial infarction (P = 0.16 and an 11% reduction in cardiovascular disease events (P = 0.04. After adjustment, the effects of fenofibrate on coronary events and cardiovascular disease events were 16% (P = 0.06 and 15% (P = 0.008, respectively.This novel application of a penalized Cox model for adjustment of a trial estimate of treatment efficacy incorporates evidence-based estimates for other therapies, preserves comparisons between the

  17. Excess sudden cardiac deaths after short-term clarithromycin administration in the CLARICOR trial

    DEFF Research Database (Denmark)

    Winkel, Per; Hilden, J; Hansen, Jørgen Fischer

    2011-01-01

    Objectives: To elucidate potential mechanisms for the clarithromycin-induced excess mortality observed in the CLARICOR trial during 2.6 year follow-up of patients with stable coronary artery disease. Methods: Cox analyses using out-of-hospital death as a proxy for sudden death compared to in-hospital...... CV death in patients not on statins at trial entry (HR: 2.61, 95% CI: 1.69–4.05, p administration was significantly associated with increased risk of sudden CV death in stable...

  18. Future long-term trials of postmenopausal hormone replacement therapy - what is possible and what is the optimal protocol and regimen?

    Science.gov (United States)

    Purbrick, B; Stranks, K; Sum, C; MacLennan, A H

    2012-06-01

    The ideal long-term, randomized, placebo-controlled trial of hormone replacement therapy (HRT) from near menopause for up to 30 years to assess major morbidity and mortality is impractical because of high cost, participant retention, therapy compliance, and continuity of research staff and funding. Also the trial regimen may become outdated. It is nihilistic to demand such a long-term trial before endorsing HRT. However, medium-term trials using surrogate measures for long-term morbidity and mortality are possible and two are near completion. If these studies have been able to maintain reasonable participant retention, therapy compliance and minimal breach of protocol, they will set standards for trials of new HRT regimens. This paper discusses lessons learnt from past attempts at long-term trials and suggests the currently optimal protocol and cost of assessing new HRT regimens to optimize potential benefits and minimize adverse effects. A 5-7-year randomized, placebo-controlled trial of a flexible transdermal estrogen regimen ± either a selective estrogen receptor modulator, e.g. bazedoxifene, or micronized progesterone is discussed. Mild to moderately symptomatic women, 1-4 years post menopause, can be recruited via general practice and group meetings. Future trials should be funded by independent agencies and are high priority in women's health.

  19. Timing of birth for women with a twin pregnancy at term: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Haslam Ross R

    2010-10-01

    Full Text Available Abstract Background There is a well recognized risk of complications for both women and infants of a twin pregnancy, increasing beyond 37 weeks gestation. Preterm birth prior to 37 weeks gestation is a recognized complication of a twin pregnancy, however, up to 50% of twins will be born after this time. The aims of this randomised trial are to assess whether elective birth at 37 weeks gestation compared with standard care in women with a twin pregnancy affects the risk of perinatal death, and serious infant complications. Methods/Design Design: Multicentred randomised trial. Inclusion Criteria: women with a twin pregnancy at 366 weeks or more without contraindication to continuation of pregnancy. Trial Entry & Randomisation: Following written informed consent, eligible women will be randomised from 36+6 weeks gestation. The randomisation schedule uses balanced variable blocks, with stratification for centre of birth and planned mode of birth. Women will be randomised to either elective birth or standard care. Treatment Schedules: Women allocated to the elective birth group will be planned for elective birth from 37 weeks gestation. Where the plan is for vaginal birth, this will involve induction of labour. Where the plan is for caesarean birth, this will involve elective caesarean section. For women allocated to standard care, birth will be planned for 38 weeks gestation or later. Where the plan is for vaginal birth, this will involve either awaiting the spontaneous onset of labour, or induction of labour if required. Where the plan is for caesarean birth, this will involve elective caesarean section (after 38 and as close to 39 weeks as possible. Primary Study Outcome: A composite of perinatal mortality or serious neonatal morbidity. Sample Size: 460 women with a twin pregnancy to show a reduction in the composite outcome from 16.3% to 6.7% with adjustment for the clustering of twin infants within mothers (p = 0.05, 80% power. Discussion This

  20. One-trial conditioned taste aversion in Lymnaea: good and poor performers in long-term memory acquisition.

    Science.gov (United States)

    Sugai, Rio; Azami, Sachiyo; Shiga, Hatsuki; Watanabe, Takayuki; Sadamoto, Hisayo; Kobayashi, Suguru; Hatakeyama, Dai; Fujito, Yutaka; Lukowiak, Ken; Ito, Etsuro

    2007-04-01

    In the majority of studies designed to elucidate the causal mechanisms of memory formation, certain members of the experimental cohort, even though subjected to exactly the same conditioning procedures, remember significantly better than others, whereas others show little or no long-term memory (LTM) formation. To begin to address the question of why this phenomenon occurs and thereby help clarify the causal mechanism of LTM formation, we used a conditioned taste aversion (CTA) procedure on individuals of the pond snail Lymnaea stagnalis and analyzed their subsequent behavior. Using sucrose as an appetitive stimulus and KCl as an aversive stimulus, we obtained a constant ratio of ;poor' to ;good' performers for CTA-LTM. We found that approximately 40% of trained snails possessed LTM following a one-trial conditioning procedure. When we examined the time-window necessary for the memory consolidation, we found that if we cooled snails to 4 degrees C for 30 min within 10 min after the one-trial conditioning, LTM was blocked. However, with delayed cooling (i.e. longer than 10 min), LTM was present. We could further interfere with LTM formation by inducing inhibitory learning (i.e. backward conditioning) after the one-trial conditioning. Finally, we examined whether we could motivate snails to acquire LTM by depriving them of food for 5 days before the one-trial conditioning. Food-deprived snails, however, failed to exhibit LTM following the one-trial conditioning. These results will help us begin to clarify why some individuals are better at learning and forming memory for specific tasks at the neuronal level.

  1. Long term effectiveness on prescribing of two multifaceted educational interventions: results of two large scale randomized cluster trials.

    Directory of Open Access Journals (Sweden)

    Nicola Magrini

    Full Text Available INTRODUCTION: Information on benefits and risks of drugs is a key element affecting doctors' prescribing decisions. Outreach visits promoting independent information have proved moderately effective in changing prescribing behaviours. OBJECTIVES: Testing the short and long-term effectiveness on general practitioners' prescribing of small groups meetings led by pharmacists. METHODS: Two cluster open randomised controlled trials (RCTs were carried out in a large scale NHS setting. Ad hoc prepared evidence based material were used considering a therapeutic area approach--TEA, with information materials on osteoporosis or prostatic hyperplasia--and a single drug oriented approach--SIDRO, with information materials on me-too drugs of 2 different classes: barnidipine or prulifloxacin. In each study, all 115 Primary Care Groups in a Northern Italy area (2.2 million inhabitants, 1737 general practitioners were randomised to educational small groups meetings, in which available evidence was provided together with drug utilization data and clinical scenarios. Main outcomes were changes in the six-months prescription of targeted drugs. Longer term results (24 and 48 months were also evaluated. RESULTS: In the TEA trial, one of the four primary outcomes showed a reduction (prescription of alfuzosin compared to tamsulosin and terazosin in benign prostatic hyperplasia: prescribing ratio -8.5%, p = 0.03. Another primary outcome (prescription of risedronate showed a reduction at 24 and 48 months (-7.6%, p = 0.02; and -9,8%, p = 0.03, but not at six months (-5.1%, p = 0.36. In the SIDRO trial both primary outcomes showed a statistically significant reduction (prescription of barnidipine -9.8%, p = 0.02; prescription of prulifloxacin -11.1%, p = 0.04, which persisted or increased over time. INTERPRETATION: These two cluster RCTs showed the large scale feasibility of a complex educational program in a NHS setting, and its potentially

  2. Short-term effect of cocoa product consumption on lipid profile: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Jia, Lei; Liu, Xuan; Bai, Yong Yi; Li, Shao Hua; Sun, Kai; He, Chen; Hui, Rutai

    2010-07-01

    The effect of cocoa products on lipid changes is controversial. We aimed to identify and quantify the effect of cocoa on total cholesterol, LDL cholesterol, and HDL cholesterol. A comprehensive literature search was conducted for relevant trials of cocoa on lipid profile. Weighted mean differences were calculated for net changes in lipid concentrations by using fixed-effects or random-effects models. Previously defined subgroup analyses were performed to identify the source of heterogeneity. Eight trials (involving 215 participants) were included and evaluated. Because there was only one relatively longer-term study, we focused on the short-term data to evaluate the effects of cocoa on plasma lipid. Cocoa consumption significantly lowered LDL cholesterol by 5.87 mg/dL (95% CI: -11.13, -0.61; P consumption significantly reduced blood cholesterol, but the changes were dependent on the dose of cocoa consumption and the healthy status of participants. There was no dose response and no effect in healthy participants. Future high-quality studies are needed to determine the efficiency of moderate cocoa consumption on lipid profile in long-term intervention and in subjects with other cardiometabolic risk factors.

  3. Efficacy of psychodynamic short-term psychotherapy for depressed breast cancer patients: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Zwerenz Rüdiger

    2012-12-01

    Full Text Available Abstract Background There is a lack of psychotherapeutic trials of treatments of comorbid depression in cancer patients. Our study determines the efficacy of a manualized short-term psychodynamic psychotherapy and predictors of outcome by personality and quality of the therapeutic relationship. Methods/design Eligible breast cancer patients with comorbid depression are assigned to short-term psychodynamic psychotherapy (up to 20 + 5 sessions or to treatment as usual (augmented by recommendation for counseling center and physician information. We plan to recruit a total of 180 patients (90 per arm in two centers. Assessments are conducted pretreatment, after 6 (treatment termination and 12 months (follow-up. The primary outcome measures are reduction of the depression score in the Hospital Anxiety and Depression Scale and remission of depression as assessed by means of the Structured Clinical Interview for DSM IV Disorders by independent, blinded assessors at treatment termination. Secondary outcomes refer to quality of life. Discussion We investigate the efficacy of short-term psychodynamic psychotherapy in acute care and we aim to identify predictors for acceptance and success of treatment. Trial registration ISRCTN96793588

  4. Conduta Obstétrica na Apresentação Pélvica Obstetric Management in Breech Presentation

    Directory of Open Access Journals (Sweden)

    Márcia Maria Auxiliadora de Aquino

    2000-09-01

    Full Text Available Objetivo: avaliar os resultados da assistência ao parto de gestantes com apresentação pélvica. Pacientes e Métodos: estudo descritivo em que foram analisadas 160 gestantes com feto em apresentação pélvica, com recém-nascidos vivos, divididas em 2 grupos conforme o tipo de parto. Foram estudados dados clínicos referentes ao trabalho de parto, parto e recém-nascido (RN. Para os procedimentos estatísticos comparararam-se os partos vaginais às cesarianas, utilizando cálculo de médias, desvio-padrão, chi² e os testes de Mann-Whitney e t de Student. Resultados: o índice geral de cesárea foi de 81,2%. A idade gestacional e o peso do RN foram significativamente menores no grupo de parto vaginal. A prematuridade e o baixo peso do RN estiveram significativamente associados ao parto vaginal. Somente 14 recém-nascidos tiveram índice de Apgar Purpose: to evaluate the results of assistance to breech deliveries. Methods: this was a descriptive study where 160 pregnant women with breech presentation and live newborns were analyzed. They were divided into two groups according to the route of delivery. Clinical data concerning labor, delivery and newborns were studied. For statistical analysis vaginal deliveries were compared with cesarean sections using mean and standard deviation estimates, Student's t, Mann-Whitney and chi² tests. Results: the global cesarean section rate was 81.2%. The gestational age and the weight of the newborns were significantly lower in the vaginal delivery group. Prematurity and low birth weight were significantly associated with vaginal delivery. Only 14 newborns had an Apgar score below 7 at the fifth minute, almost 60% of them in the vaginal delivery group. Conclusions: this population presented a high cesarean section rate and also high perinatal morbidity, prematurity and low birth weight in the vaginal delivery group. These findings do not allow conclusions regarding the real relationships among breech

  5. Analysis on the Long Term Effect of Trial Test Road Constructed on Batu Pahat Soft Clay (BPSC) at Recess UTHM

    Science.gov (United States)

    Idrus, M. M. M.; Edayu, A. E.; Adnan, Z.; Ismail, B.

    2016-07-01

    The reinforcement used in soil for construction of roads on the soft clay is very important as it will determine the level of service of the road after it was built. Damage or defects on the road surface to be an indicator of the level of the road has dropped and shows the deformation of the road. For this research, an analysis has carried out on the long-term effect of trial test road constructed on Batu Pahat Soft Clay (BPSC) at RECESS UTHM. Through this research, the reinforcement using Rawell Geosynthetic Clay Liner (RGCL) was the best with the stability is 14964 N, a low flow is 2.69mm, stiffness modulus is 1766 MPa, the peak load is 739.4 N and a lower horizontal deformation which is 1.71 µm compared Woven Geotextile section and section without geotextile [1] [9]. In terms of deformation can be seen clearly from physical observations that section without geotextile suffered significant damage than others. Settlement of road can also be analyzed by a longitudinal section that plotted based on the result of leveling work. After that, settlements are more visible way on the right side of the road trial. Through lab tests conducted, it indicate that the coring samples obtained from sites of each section meets the specifications set by the Jabatan Kerja Raya (JKR) in terms of stability, flow and stiffness [1]. Through this study, a trial road built on soft soil can be used as a test site because of the uniqueness of these roads which has three different types of reinforcements.

  6. Cluster Randomized Controlled Trial: Clinical and Cost-Effectiveness of a System of Longer-Term Stroke Care.

    Science.gov (United States)

    Forster, Anne; Young, John; Chapman, Katie; Nixon, Jane; Patel, Anita; Holloway, Ivana; Mellish, Kirste; Anwar, Shamaila; Breen, Rachel; Knapp, Martin; Murray, Jenni; Farrin, Amanda

    2015-08-01

    We developed a new postdischarge system of care comprising a structured assessment covering longer-term problems experienced by patients with stroke and their carers, linked to evidence-based treatment algorithms and reference guides (the longer-term stroke care system of care) to address the poor longer-term recovery experienced by many patients with stroke. A pragmatic, multicentre, cluster randomized controlled trial of this system of care. Eligible patients referred to community-based Stroke Care Coordinators were randomized to receive the new system of care or usual practice. The primary outcome was improved patient psychological well-being (General Health Questionnaire-12) at 6 months; secondary outcomes included functional outcomes for patients, carer outcomes, and cost-effectiveness. Follow-up was through self-completed postal questionnaires at 6 and 12 months. Thirty-two stroke services were randomized (29 participated); 800 patients (399 control; 401 intervention) and 208 carers (100 control; 108 intervention) were recruited. In intention to treat analysis, the adjusted difference in patient General Health Questionnaire-12 mean scores at 6 months was -0.6 points (95% confidence interval, -1.8 to 0.7; P=0.394) indicating no evidence of statistically significant difference between the groups. Costs of Stroke Care Coordinator inputs, total health and social care costs, and quality-adjusted life year gains at 6 months, 12 months, and over the year were similar between the groups. This robust trial demonstrated no benefit in clinical or cost-effectiveness outcomes associated with the new system of care compared with usual Stroke Care Coordinator practice. URL: http://www.controlled-trials.com. Unique identifier: ISRCTN 67932305. © 2015 Bradford Teaching Hospitals NHS Foundation Trust.

  7. Perioperative hyperoxia - Long-term impact on cardiovascular complications after abdominal surgery, a post hoc analysis of the PROXI trial

    DEFF Research Database (Denmark)

    Fonnes, Siv; Gogenur, Ismail; Sondergaard, Edith Smed

    2016-01-01

    BACKGROUND: Increased long-term mortality was found in patients exposed to perioperative hyperoxia in the PROXI trial, where patients undergoing laparotomy were randomised to 80% versus 30% oxygen during and after surgery. This post hoc follow-up study assessed the impact of perioperative hyperoxia...... included myocardial infarction, other heart disease, and acute coronary syndrome or death. Data were analysed in the Cox proportional hazards model. RESULTS: The primary outcome, acute coronary syndrome, occurred in 2.5% versus 1.3% in the 80% versus 30% oxygen group; HR 2.15 (95% CI 0.96-4.84). Patients...

  8. Randomized cross-over trial of short-term water-only fasting: metabolic and cardiovascular consequences.

    Science.gov (United States)

    Horne, B D; Muhlestein, J B; Lappé, D L; May, H T; Carlquist, J F; Galenko, O; Brunisholz, K D; Anderson, J L

    2013-11-01

    Routine, periodic fasting is associated with a lower prevalence of coronary artery disease (CAD). Animal studies show that fasting may increase longevity and alter biological parameters related to longevity. We evaluated whether fasting initiates acute changes in biomarker expression in humans that may impact short- and long-term health. Apparently-healthy volunteers (N = 30) without a recent history of fasting were enrolled in a randomized cross-over trial. A one-day water-only fast was the intervention and changes in biomarkers were the study endpoints. Bonferroni correction required p ≤ 0.00167 for significance (p fasting intervention acutely increased human growth hormone (p = 1.1 × 10⁻⁴), hemoglobin (p = 4.8 × 10⁻⁷), red blood cell count (p = 2.5 × 10⁻⁶), hematocrit (p = 3.0 × 10⁻⁶), total cholesterol (p = 5.8 × 10⁻⁵), and high-density lipoprotein cholesterol (p = 0.0015), and decreased triglycerides (p = 1.3 × 10⁻⁴), bicarbonate (p = 3.9 × 10⁻⁴), and weight (p = 1.0 × 10⁻⁷), compared to a day of usual eating. For those randomized to fast the first day (n = 16), most factors including human growth hormone and cholesterol returned to baseline after the full 48 h, with the exception of weight (p = 2.5 × 10⁻⁴) and (suggestively significant) triglycerides (p = 0.028). Fasting induced acute changes in biomarkers of metabolic, cardiovascular, and general health. The long-term consequences of these short-term changes are unknown but repeated episodes of periodic short-term fasting should be evaluated as a preventive treatment with the potential to reduce metabolic disease risk. Clinical trial registration (ClinicalTrials.gov): NCT01059760 (Expression of Longevity Genes in Response to Extended Fasting [The Fasting and Expression of Longevity Genes during Food abstinence {FEELGOOD} Trial]). Copyright © 2012 Elsevier B.V. All rights reserved.

  9. Long-term tolerability of telcagepant for acute treatment of migraine in a randomized trial

    DEFF Research Database (Denmark)

    Connor, Kathryn M; Aurora, Sheena K; Loeys, Tom

    2011-01-01

    To evaluate the long-term tolerability of telcagepant for acute treatment of intermittent migraine attacks. Background.- Telcagepant is a calcitonin gene-related peptide (CGRP) receptor antagonist being investigated for the acute treatment of migraine....

  10. Long-Term Follow-Up of a Controlled Trial of Laser Laparoscopy for Pelvic Pain

    OpenAIRE

    Jones, Kevin D.; Haines, Patricia; Sutton, Christopher J. G.

    2001-01-01

    Background and Objectives: The purpose of this study was to assess the long-term efficacy of laparoscopic laser surgery in the treatment of painful pelvic endometriosis. Methods: We conducted a long-term follow-up of 56 patients who had participated in a randomized, double-blind controlled study at a tertiary referral center for the laparoscopic treatment of endometriosis. The patients had pelvic pain, minimal-to-moderate endometriosis, and underwent laser laparoscopy. We asked patients wheth...

  11. Long-term (5 year) safety of bronchial thermoplasty: Asthma Intervention Research (AIR) trial

    DEFF Research Database (Denmark)

    Thomson, Neil C; Rubin, Adalberto S; Niven, Robert M

    2011-01-01

    Bronchial thermoplasty (BT) is a bronchoscopic procedure that improves asthma control by reducing excess airway smooth muscle. Treated patients have been followed out to 5 years to evaluate long-term safety of this procedure.......Bronchial thermoplasty (BT) is a bronchoscopic procedure that improves asthma control by reducing excess airway smooth muscle. Treated patients have been followed out to 5 years to evaluate long-term safety of this procedure....

  12. Immediate delivery compared with expectant management after preterm pre-labour rupture of the membranes close to term (PPROMT trial): a randomised controlled trial.

    Science.gov (United States)

    Morris, Jonathan M; Roberts, Christine L; Bowen, Jennifer R; Patterson, Jillian A; Bond, Diana M; Algert, Charles S; Thornton, Jim G; Crowther, Caroline A

    2016-01-30

    Preterm pre-labour ruptured membranes close to term is associated with increased risk of neonatal infection, but immediate delivery is associated with risks of prematurity. The balance of risks is unclear. We aimed to establish whether immediate birth in singleton pregnancies with ruptured membranes close to term reduces neonatal infection without increasing other morbidity. The PPROMT trial was a multicentre randomised controlled trial done at 65 centres across 11 countries. Women aged over 16 years with singleton pregnancies and ruptured membranes before the onset of labour between 34 weeks and 36 weeks and 6 days weeks who had no signs of infection were included. Women were randomly assigned (1:1) by a computer-generated randomisation schedule with variable block sizes, stratified by centre, to immediate delivery or expectant management. The primary outcome was the incidence of neonatal sepsis. Secondary infant outcomes included a composite neonatal morbidity and mortality indicator (ie, sepsis, mechanical ventilation ≥24 h, stillbirth, or neonatal death); respiratory distress syndrome; any mechanical ventilation; and duration of stay in a neonatal intensive or special care unit. Secondary maternal outcomes included antepartum or intrapartum haemorrhage, intrapartum fever, postpartum treatment with antibiotics, and mode of delivery. Women and caregivers could not be masked, but those adjudicating on the primary outcome were masked to group allocation. Analyses were by intention to treat. This trial is registered with the International Clinical Trials Registry, number ISRCTN44485060. Between May 28, 2004, and June 30, 2013, 1839 women were recruited and randomly assigned: 924 to the immediate birth group and 915 to the expectant management group. One woman in the immediate birth group and three in the expectant group were excluded from the primary analyses. Neonatal sepsis occurred in 23 (2%) of 923 neonates whose mothers were assigned to immediate birth and 29

  13. The long-term effect of minimalist shoes on running performance and injury: design of a randomised controlled trial

    Science.gov (United States)

    Fuller, Joel T; Thewlis, Dominic; Tsiros, Margarita D; Brown, Nicholas A T; Buckley, Jonathan D

    2015-01-01

    Introduction The outcome of the effects of transitioning to minimalist running shoes is a topic of interest for runners and scientists. However, few studies have investigated the longer term effects of running in minimalist shoes. The purpose of this randomised controlled trial (RCT) is to investigate the effects of a 26 week transition to minimalist shoes on running performance and injury risk in trained runners unaccustomed to minimalist footwear. Methods and analysis A randomised parallel intervention design will be used. Seventy-six trained male runners will be recruited. To be eligible, runners must be aged 18–40 years, run with a habitual rearfoot footfall pattern, train with conventional shoes and have no prior experience with minimalist shoes. Runners will complete a standardised transition to either minimalist or control shoes and undergo assessments at baseline, 6 and 26 weeks. 5 km time-trial performance (5TT), running economy, running biomechanics, triceps surae muscle strength and lower limb bone mineral density will be assessed at each time point. Pain and injury will be recorded weekly. Training will be standardised during the first 6 weeks. Primary statistical analysis will compare 5TT between shoe groups at the 6-week time point and injury incidence across the entire 26-week study period. Ethics and dissemination This RCT has been approved by the Human Research Ethics Committee of the University of South Australia. Participants will be required to provide their written informed consent prior to participation in the study. Study findings will be disseminated in the form of journal publications and conference presentations after completion of planned data analysis. Trial registration number This RCT has been registered with the Australian New Zealand Clinical Trials Registry (ACTRN12613000642785). PMID:26297368

  14. Prevention of fall-related injuries in long-term care: a randomized controlled trial of staff education.

    Science.gov (United States)

    Ray, Wayne A; Taylor, Jo A; Brown, Anne K; Gideon, Patricia; Hall, Kathi; Arbogast, Patrick; Meredith, Sarah

    2005-10-24

    Fall-related injuries, a major public health problem in long-term care, may be reduced by interventions that improve safety practices. Previous studies have shown that safety practice interventions can reduce falls; however, in long-term care these have relied heavily on external funding and staff. The aim of this study was to test whether a training program in safety practices for staff could reduce fall-related injuries in long-term care facilities. A cluster randomization clinical trial with 112 qualifying facilities and 10,558 study residents 65 years or older and not bedridden. The intervention was an intensive 2-day safety training program with 12-month follow-up. The training program targeted living space and personal safety; wheelchairs, canes, and walkers; psychotropic medication use; and transferring and ambulation. The main outcome measure was serious fall-related injuries during the follow-up period. There was no difference in injury occurrence between the intervention and control facilities (adjusted rate ratio, 0.98; 95% confidence interval, 0.83-1.16). For residents with a prior fall in facilities with the best program compliance, there was a nonsignificant trend toward fewer injuries in the intervention group (adjusted rate ratio, 0.79; 95% confidence interval, 0.57-1.10). More intensive interventions are required to prevent fall-related injuries in long-term care facilities.

  15. Regulatory Technology Development Plan - Sodium Fast Reactor: Mechanistic Source Term - Trial Calculation

    International Nuclear Information System (INIS)

    Grabaskas, David

    2016-01-01

    The potential release of radioactive material during a plant incident, referred to as the source term, is a vital design metric and will be a major focus of advanced reactor licensing. The U.S. Nuclear Regulatory Commission has stated an expectation for advanced reactor vendors to present a mechanistic assessment of the potential source term in their license applications. The mechanistic source term presents an opportunity for vendors to realistically assess the radiological consequences of an incident, and may allow reduced emergency planning zones and smaller plant sites. However, the development of a mechanistic source term for advanced reactors is not without challenges, as there are often numerous phenomena impacting the transportation and retention of radionuclides. This project sought to evaluate U.S. capabilities regarding the mechanistic assessment of radionuclide release from core damage incidents at metal fueled, pool-type sodium fast reactors (SFRs). The purpose of the analysis was to identify, and prioritize, any gaps regarding computational tools or data necessary for the modeling of radionuclide transport and retention phenomena. To accomplish this task, a parallel-path analysis approach was utilized. One path, led by Argonne and Sandia National Laboratories, sought to perform a mechanistic source term assessment using available codes, data, and models, with the goal to identify gaps in the current knowledge base. The second path, performed by an independent contractor, performed sensitivity analyses to determine the importance of particular radionuclides and transport phenomena in regards to offsite consequences. The results of the two pathways were combined to prioritize gaps in current capabilities.

  16. Regulatory Technology Development Plan - Sodium Fast Reactor: Mechanistic Source TermTrial Calculation

    Energy Technology Data Exchange (ETDEWEB)

    Grabaskas, David [Argonne National Lab. (ANL), Argonne, IL (United States). Nuclear Engineering Division; Bucknor, Matthew [Argonne National Lab. (ANL), Argonne, IL (United States). Nuclear Engineering Division; Jerden, James [Argonne National Lab. (ANL), Argonne, IL (United States). Nuclear Engineering Division; Brunett, Acacia J. [Argonne National Lab. (ANL), Argonne, IL (United States). Nuclear Engineering Division; Denman, Matthew [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States). Nuclear Engineering Division; Clark, Andrew [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States). Nuclear Engineering Division; Denning, Richard S. [Consultant, Columbus, OH (United States)

    2016-10-01

    The potential release of radioactive material during a plant incident, referred to as the source term, is a vital design metric and will be a major focus of advanced reactor licensing. The U.S. Nuclear Regulatory Commission has stated an expectation for advanced reactor vendors to present a mechanistic assessment of the potential source term in their license applications. The mechanistic source term presents an opportunity for vendors to realistically assess the radiological consequences of an incident, and may allow reduced emergency planning zones and smaller plant sites. However, the development of a mechanistic source term for advanced reactors is not without challenges, as there are often numerous phenomena impacting the transportation and retention of radionuclides. This project sought to evaluate U.S. capabilities regarding the mechanistic assessment of radionuclide release from core damage incidents at metal fueled, pool-type sodium fast reactors (SFRs). The purpose of the analysis was to identify, and prioritize, any gaps regarding computational tools or data necessary for the modeling of radionuclide transport and retention phenomena. To accomplish this task, a parallel-path analysis approach was utilized. One path, led by Argonne and Sandia National Laboratories, sought to perform a mechanistic source term assessment using available codes, data, and models, with the goal to identify gaps in the current knowledge base. The second path, performed by an independent contractor, performed sensitivity analyses to determine the importance of particular radionuclides and transport phenomena in regards to offsite consequences. The results of the two pathways were combined to prioritize gaps in current capabilities.

  17. Long-term impact of endometrial cancer diagnosis and treatment on health-related quality of life and cancer survivorship : Results from the randomized PORTEC-2 trial

    NARCIS (Netherlands)

    De Boer, Stephanie M.; Nout, Remi A.; Jurgenliemk-Schulz, Ina M.; Jobsen, Jan J; Lutgens, Ludy C.H.W.; Van Der Steen-Banasik, Elzbieta M.; Mens, Jan Willem M.; Slot, Annerie; Stenfert Kroese, Marika C.; Oerlemans, Simone; Putter, Hein; Verhoeven-Adema, Karen W.; Nijman, Hans W; Creutzberg, Carien L.

    2015-01-01

    Purpose: To evaluate the long-term health-related quality of life (HRQL) after external beam radiation therapy (EBRT) or vaginal brachytherapy (VBT) among PORTEC-2 trial patients, evaluate long-term bowel and bladder symptoms, and assess the impact of cancer on these endometrial cancer (EC)

  18. Long-term impact of endometrial cancer diagnosis and treatment on health-related quality of life and cancer survivorship : Results from the randomized PORTEC-2 trial

    NARCIS (Netherlands)

    de Boer, Stephanie M.; Nout, Remi A.; Jurgenliemk-Schulz, Ina M.; Jobsen, Jan J.; Lutgens, Ludy C. H. W.; van der Steen-Banasik, Elzbieta M.; Mens, Jan Willem M.; Slot, Annerie; Kroese, Marika C. Stenfert; Oerlemans, Simone; Putter, Hein; Verhoeven-Adema, Karen W.; Nijman, Hans W.; Creutzberg, Carien L.

    2015-01-01

    Purpose To evaluate the long-term health-related quality of life (HRQL) after external beam radiation therapy (EBRT) or vaginal brachytherapy (VBT) among PORTEC-2 trial patients, evaluate long-term bowel and bladder symptoms, and assess the impact of cancer on these endometrial cancer (EC)

  19. Long-Term Impact of Endometrial Cancer Diagnosis and Treatment on Health-Related Quality of Life and Cancer Survivorship : Results From the Randomized PORTEC-2 Trial

    NARCIS (Netherlands)

    de Boer, Stephanie M.; Nout, Remi A.; Jurgenliemk-Schulz, Ina M.; Jobsen, Jan J.; Lutgens, Ludy C. H. W.; van der Steen-Banasik, Elzbieta M.; Mens, Jan Willem M.; Slot, Annerie; Kroese, Marika C. Stenfert; Oerlemans, Simone; Putter, Hein; Verhoeven-Adema, Karen W.; Nijman, Hans W.; Creutzberg, Carien L.

    2015-01-01

    Purpose: To evaluate the long-term health-related quality of life (HRQL) after external beam radiation therapy (EBRT) or vaginal brachytherapy (VBT) among PORTEC-2 trial patients, evaluate long-term bowel and bladder symptoms, and assess the impact of cancer on these endometrial cancer (EC)

  20. Long-term child follow-up after large obstetric randomised controlled trials for the evaluation of perinatal interventions: a systematic review of the literature

    NARCIS (Netherlands)

    Teune, M. J.; van Wassenaer, A. G.; Malin, G. L.; Asztalos, E.; Alfirevic, Z.; Mol, B. W. J.; Opmeer, B. C.

    2013-01-01

    Although the hope is that many perinatal interventions are performed with an ultimate aim to improve the long-term health and development of the child, long-term outcome is rarely used as a primary end-point in perinatal randomised controlled trials (RCTs). To evaluate how often and with which tools

  1. Are intrapartum and neonatal deaths in breech delivery at term potentially avoidable?--a blinded controlled audit

    DEFF Research Database (Denmark)

    Krebs, Lone; Langhoff-Roos, Jens; Bødker, Birgit

    2002-01-01

    -92 were studied. For each of the 12 deaths two controls matched by presentation and planned mode of delivery were selected. Eleven obstetricians assessed the care through narratives that ended when the infant was delivered to umbilicus and stated if the infant died, and whether the "possible death...

  2. Short‐term efficacy of Epley's manoeuvre: a double‐blind randomised trial

    Science.gov (United States)

    von Brevern, M; Seelig, T; Radtke, A; Tiel‐Wilck, K; Neuhauser, H; Lempert, T

    2006-01-01

    Background Benign paroxysmal positional vertigo of the posterior canal (PC‐BPPV) is a common vestibular disorder and can be easily treated with Epley's manoeuvre. Thus far, the short‐term efficacy of Epley's manoeuvre for treatment of PC‐BPPV is unknown. Objectives To evaluate the efficacy of Epley's manoeuvre for treatment of PC‐BPPV 24 h after applying the manoeuvre. Methods The short‐term efficacy of Epley's manoeuvre was compared with a sham procedure in 66 patients with PC‐BPPV by using a double‐blind randomised study design. Results 24 h after treatment, 28 of 35 (80%) patients in the Epley's manoeuvre group had neither vertigo nor nystagmus on positional testing compared with 3 of 31 (10%) patients in the sham group (p<0.001). Conclusion Epley's manoeuvre is shown to resolve PC‐BPPV both effectively and rapidly. PMID:16549410

  3. Enhancing long-term memory with stimulation tunes visual attention in one trial

    OpenAIRE

    Reinhart, Robert M. G.; Woodman, Geoffrey F.

    2014-01-01

    Theories of attention propose that we rely on working memory to control attention by maintaining target presentations in this active store as our visual systems are used to search for certain objects. Here, we show that the tuning of perceptual attention can be sharply accelerated by noninvasive brain stimulation. Our electrophysiological measurements showed that these improvements in attentional tuning were preceded by changes in event-related potentials thought to index long-term memory, bu...

  4. Dreaming during sevoflurane or propofol short-term sedation: a randomised controlled trial.

    Science.gov (United States)

    Xu, G H; Liu, X S; Yu, F Q; Gu, E W; Zhang, J; Royse, A G; Wang, K

    2012-05-01

    Prior reports suggest that dreaming during anaesthesia is dependent on recovery time. Dreaming during sedation may impact patient satisfaction. The current study explores the incidence and content of dreaming during short-term sedation with sevoflurane or propofol and investigates whether dreaming is affected by recovery time. A total of 200 women undergoing first trimester abortion (American Society of Anesthesiologists physical status I) participated in the study. Patients were randomly assigned to receive either sevoflurane or propofol for short-term sedation. Patients were interviewed upon emergence with the modified Brice questionnaire. The results showed the incidence of dreaming was significantly different between anaesthesia groups with 60% (60/100) of the sevoflurane group and 33% (33/100) of the propofol group (P=0.000). However, recovery time did not significantly differ between groups. In the sevoflurane group, a greater number of dreamers could not recall what they had dreamed about (P=0.02) and more patients reported dreams that had no sound (P=0.03) or movement (P=0.001) compared with dreamers in the propofol group. Most participants reported dreams with positive emotional content and this did not significantly differ between groups. Anaesthesia administered had no effect on patient satisfaction. The results suggest that the incidence of dreaming was not affected by recovery time. Patient satisfaction was not influenced by choice of sedative and/or by the occurrence of dreaming during sevoflurane or propofol short-term sedation.

  5. Gemfibrozil in late preterm and term neonates with moderate jaundice: a randomized controlled trial.

    Science.gov (United States)

    Jaikrishan; Kumar, Praveen; Narang, Anil

    2009-12-01

    To determine, if oral Gemfibrozil is effective in decreasing the duration of phototherapy by at least 24 hours in neonates >34 weeks gestation with non-hemolytic jaundice, as compared to placebo. Double blind placebo controlled randomized controlled trial. Tertiary care neonatal unit in north India. Ninety seven neonates >34 weeks gestation with non-hemolytic jaundice within first 7 days of life requiring phototherapy. Two doses of Gemfibrozil (60 mg/kg/dose) or placebo, 12 hours apart. Babies were treated with single surface special blue light phototherapy. Serum total bilirubin (STB) was measured 8 hourly. Phototherapy was stopped if two consecutive STB values were below phototherapy zone. Duration of phototherapy. The median (IQR) duration of phototherapy was 40 (30, 60) hours in Gemfibrozil and 36 (19, 55) hours in the placebo group (P=0.13). The peak STB levels were 16.8 +/- 2.7 mg/dL and 16.3 +/- 2.3 mg/dL in Gemfibrozil and placebo groups, respectively. No side effect of the drug or placebo was noticed. Two doses of gemfibrozil (60 mg/kg/dose) given 12 hours apart were not able to reduce the duration of phototherapy, or peak bilirubin level in babies > 34 weeks gestation with non-hemolytic jaundice in the first week of life. Gemfibrozil was not associated with any side effects.

  6. Short-Term Effect of Laser Acupuncture on Lower Back Pain: A Randomized, Placebo-Controlled, Double-Blind Trial

    Directory of Open Access Journals (Sweden)

    Jae-Young Shin

    2015-01-01

    Full Text Available Purpose. This trial was performed to investigate the efficacy of laser acupuncture for the alleviation of lower back pain. Methods. This was a randomized, placebo-controlled, double-blind trial. Fifty-six participants were randomly assigned to either the laser acupuncture group (n=28 or the sham laser acupuncture group (n=28. Participants in both groups received three treatment sessions over the course of one week. Thirteen acupuncture points were selected. The visual analogue scale for pain, pressure pain threshold, Patient Global Impression of Change, and Euro-Quality-of-Life Five Dimensions questionnaire (Korean version were used to evaluate the effect of laser acupuncture treatment on lower back pain. Results. There were no significant differences in any outcome between the two groups, although the participants in both groups showed a significant improvement in each assessed parameter relative to the baseline values. Conclusion. Although there was no significant difference in outcomes between the two groups, the results suggest that laser acupuncture can provide effective pain alleviation and can be considered an option for relief from lower back pain. Further studies using long-term intervention, a larger sample size, and rigorous methodology are required to clarify the effect of laser acupuncture on lower back pain.

  7. The role of long-term doxycycline in patients of idiopathic pulmonaryfibrosis: The results of an open prospective trial

    Directory of Open Access Journals (Sweden)

    Bhattacharyya Parthasarathi

    2009-01-01

    Full Text Available Objective: To evaluate the effect of long term use of doxycycline in IPF patients. Materials and Methods: Patients of IPF, selected randomly from out patient services and diagnosed on the basis of HRCT chest, were put on doxycycline in an open prospective trial. They were followed up with monitoring of subjective well being along with measurement of pulse rate and arterial oxygen saturation at rest and after a fixed and certain exercise, forced vital capacity, six minutes walk test, St Georges Respiratory questionnaire, and serial chest X-rays. Results: Out of seven patients put on doxycycline, six of them continued the drug for a mean period of 531.43 (± 328.88 days. All the patients tolerated the drug well and had shown uniform subjective and overall objective improvement in all the parameters concerned; the change in the radiological parameter being statistically significant. Conclusion: Doxycycline merits an appropriate clinical trial in the management of idiopathic pulmonary fibrosis. This widely used and relatively safe drug can add a new dimension to the therapeutic regimen. However, further in-depth studies will be required to evaluate its role in the management of IPF.

  8. The effects of long- and short-term interdisciplinary treatment approaches in women with fibromyalgia: a randomized controlled trial.

    Science.gov (United States)

    Saral, Ilknur; Sindel, Dilsad; Esmaeilzadeh, Sina; Sertel-Berk, Hanife Ozlem; Oral, Aydan

    2016-10-01

    We investigated the effects of long- and short-term interdisciplinary treatment approaches for reducing symptoms and improving health-related quality of life (HRQoL) and physical functions of patients with fibromyalgia and compared the effects of two different interdisciplinary treatment approaches. We conducted a prospective, randomized, controlled trial involving 66 women with fibromyalgia eligible for the study at a university hospital setting. The patients were randomized into three groups (allocation ratio 1:1:1) using a computer-generated random numbers: a long-term interdisciplinary treatment group (LG, n = 22) that participated in 10 sessions (3-h once-weekly session for 10 weeks) of cognitive behavioral therapy (CBT) together with exercise training and other fibromyalgia related educational programs (two full days); a short-term interdisciplinary treatment group (SG, n = 22) that received two full days of educational, exercise, and CBT programs; and a control group (CG, n = 22). The patients were evaluated at baseline and 6 months after treatment using the visual analog scale (pain, fatigue, and sleep), Fibromyalgia Impact Questionnaire, Beck Depression Inventory, Short Form-36, tender point numbers, and pressure algometry as primary outcomes. The statistical analysis was confined to the 'per-protocol' set. No blinding was performed. The number of patients analyzed was 21 in the LG, 19 in the SG, and 19 in the CG. The intensity of pain (p treatment approaches when compared with controls; the long-term treatment was found more effective in reducing pain than the short-term. Both, long- and short-term interdisciplinary treatments were effective in reducing the severity of some symptoms and disease activity in patients with fibromyalgia. The short-term program well meets the needs of women with fibromyalgia particularly in relation to pain and health status as measured using FIQ; however, a long-term program may be beneficial in reducing fatigue and

  9. 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.

  10. Enhancing long-term memory with stimulation tunes visual attention in one trial.

    Science.gov (United States)

    Reinhart, Robert M G; Woodman, Geoffrey F

    2015-01-13

    Scientists have long proposed that memory representations control the mechanisms of attention that focus processing on the task-relevant objects in our visual field. Modern theories specifically propose that we rely on working memory to store the object representations that provide top-down control over attentional selection. Here, we show that the tuning of perceptual attention can be sharply accelerated after 20 min of noninvasive brain stimulation over medial-frontal cortex. Contrary to prevailing theories of attention, these improvements did not appear to be caused by changes in the nature of the working memory representations of the search targets. Instead, improvements in attentional tuning were accompanied by changes in an electrophysiological signal hypothesized to index long-term memory. We found that this pattern of effects was reliably observed when we stimulated medial-frontal cortex, but when we stimulated posterior parietal cortex, we found that stimulation directly affected the perceptual processing of the search array elements, not the memory representations providing top-down control. Our findings appear to challenge dominant theories of attention by demonstrating that changes in the storage of target representations in long-term memory may underlie rapid changes in the efficiency with which humans can find targets in arrays of objects.

  11. Long-Term Effects and Prognosis in Acute Heart Failure Treated with Tolvaptan: The AVCMA Trial

    Directory of Open Access Journals (Sweden)

    Satoshi Suzuki

    2014-01-01

    Full Text Available Background. Diuresis is a major therapy for the reduction of congestive symptoms in acute decompensated heart failure (ADHF patients. We previously reported the efficacy and safety of tolvaptan compared to carperitide in hospitalized patients with ADHF. There were some reports of cardio- and renal-protective effects in carperitide; therefore, the purpose of this study was to compare the long-term effects of tolvaptan and carperitide on cardiorenal function and prognosis. Methods and Results. One hundred and five ADHF patients treated with either tolvaptan or carperitide were followed after hospital discharge. Levels of plasma B-type natriuretic peptide, serum sodium, potassium, creatinine, and estimated glomerular filtration rate were measured before administration of tolvaptan or carperitide at baseline, the time of discharge, and one year after discharge. These data between tolvaptan and carperitide groups were not different one year after discharge. Kaplan-Meier survival curves demonstrated that the event-free rate regarding all events, cardiac events, all cause deaths, and rehospitalization due to worsening heart failure was not significantly different between tolvaptan and carperitide groups. Conclusions. We demonstrated that tolvaptan had similar effects on cardiac and renal function and led to a similar prognosis in the long term, compared to carperitide.

  12. Long-term outcomes from the National Drug Abuse Treatment Clinical Trials Network Prescription Opioid Addiction Treatment Study.

    Science.gov (United States)

    Weiss, Roger D; Potter, Jennifer Sharpe; Griffin, Margaret L; Provost, Scott E; Fitzmaurice, Garrett M; McDermott, Katherine A; Srisarajivakul, Emily N; Dodd, Dorian R; Dreifuss, Jessica A; McHugh, R Kathryn; Carroll, Kathleen M

    2015-05-01

    Despite the growing prevalence of prescription opioid dependence, longitudinal studies have not examined long-term treatment response. The current study examined outcomes over 42 months in the Prescription Opioid Addiction Treatment Study (POATS). POATS was a multi-site clinical trial lasting up to 9 months, examining different durations of buprenorphine-naloxone plus standard medical management for prescription opioid dependence, with participants randomized to receive or not receive additional opioid drug counseling. A subset of participants (N=375 of 653) enrolled in a follow-up study. Telephone interviews were administered approximately 18, 30, and 42 months after main-trial enrollment. Comparison of baseline characteristics by follow-up participation suggested few differences. At Month 42, much improvement was seen: 31.7% were abstinent from opioids and not on agonist therapy; 29.4% were receiving opioid agonist therapy, but met no symptom criteria for current opioid dependence; 7.5% were using illicit opioids while on agonist therapy; and the remaining 31.4% were using opioids without agonist therapy. Participants reporting a lifetime history of heroin use at baseline were more likely to meet DSM-IV criteria for opioid dependence at Month 42 (OR=4.56, 95% CI=1.29-16.04, popioid abstinence. Eight percent (n=27/338) used heroin for the first time during follow-up; 10.1% reported first-time injection heroin use. Long-term outcomes for those dependent on prescription opioids demonstrated clear improvement from baseline. However, a subset exhibited a worsening course, by initiating heroin use and/or injection opioid use. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  13. The Impact of Short-Term Video Games on Performance among Children with Developmental Delays: A Randomized Controlled Trial

    Science.gov (United States)

    Hsieh, Ru-Lan; Lee, Wen-Chung; Lin, Jui-Hsiang

    2016-01-01

    This prospective, randomized controlled study investigated the effects of short-term interactive video game playing among children with developmental delays participating in traditional rehabilitation treatment at a rehabilitation clinic. One hundred and one boys and 46 girls with a mean age of 5.8 years (range: 3 to 12 years) were enrolled in this study. All patients were confirmed to suffer from developmental delays, and were participating in traditional rehabilitation treatment. Children participated in two periods of 4 weeks each, group A being offered intervention of eight 30-minute sessions of interactive video games in the first period, and group B in the second, in addition to the traditional rehabilitation treatment. The physical, psychosocial, and total health of the children was periodically assessed using the parent-reported Pediatric Quality of Life Inventory-Generic Core Scales (PedsQL); and the children’s upper extremity and physical function, transfer and basic mobility, sports and physical functioning, and global functioning were assessed using the Pediatric Outcomes Data Collection Instrument. Parental impact was evaluated using the PedsQL-Family Impact Module for family function, PedsQL-Health Satisfaction questionnaire for parents’ satisfaction with their children’s care and World Health Organization-Quality of Life-Brief Version for quality of life. Compared with the baseline, significant improvements of physical function were observed in both groups (5.6 ± 19.5, p = 0.013; 4.7 ± 13.8, p = 0.009) during the intervention periods. No significant improvement of psychosocial health, functional performance, or family impact was observed in children with developmental delays. Short-term interactive video game play in conjunction with traditional rehabilitation treatment improved the physical health of children with developmental delays. Trial Registration: ClinicalTrials.gov NCT02184715 PMID:26983099

  14. Combined therapy in gastro-esophageal reflux disease of term neonates resistant to conservative therapy and monotherapy: a clinical trial

    Directory of Open Access Journals (Sweden)

    Peymaneh Alizadeh Taheri

    2018-05-01

    Full Text Available Background: Gastroesophageal reflux disease (GERD is one of the most common problems in neonates. The main clinical manifestations of neonatal GERD are frequent regurgitation or vomiting associated with irritability, crying, anorexia or feeding refusal, failure to thrive, arching of the back and sleep disturbance.Aims: As no study has compared metoclopramide plus ranitidine with metoclopramide plus omeprazole in the management of neonatal GERD resistant to conservative and monotherapy, this study was carried out.Study design: This study was a randomized clinical trial of term neonates with GERD resistant to conservative and monotherapy admitted to the neonatal ward of Bahrami Children Hospital during 2013-2015. Totally, 116 term neonates (mean age 10.53 ± 8.17 days; girls 50.9% were randomly assigned to a double blind trial with either oral omeprazole plus metoclopramide (group A or oral ranitidine plus metoclopramide (group B. The changes of the symptoms and signs were recorded after one week and one month.Results: There was no significant difference in demographic and baseline characteristics between the two groups. The response rate of “omeprazole plus metoclopramide” was significantly higher than “ranitidine plus metoclopramide” (93.74% ± 7.28% vs. 75.43% ± 23.24%, p = 0.028. All clinical manifestations recovered significantly in group A while the response rate of irritability and wheezing was not significant in group B (primary outcome. There were no side effects in either group after one week and one month of treatment (secondary outcome.Conclusions: The response rate was > 70% in each group, but it was significantly higher in group A (> 90%. Combination of each acid suppressant with metoclopramide led to higher response rate in comparison with monotherapy used before intervention.

  15. Long term effect of depression care management on mortality in older adults: follow-up of cluster randomized clinical trial in primary care

    OpenAIRE

    Gallo, Joseph J; Morales, Knashawn H; Bogner, Hillary R; Raue, Patrick J; Zee, Jarcy; Bruce, Martha L; Reynolds, Charles F

    2013-01-01

    Objective To investigate whether an intervention to improve treatment of depression in older adults in primary care modified the increased risk of death associated with depression. Design Long term follow-up of multi-site practice randomized controlled trial (PROSPECT?Prevention of Suicide in Primary Care Elderly: Collaborative Trial). Setting 20 primary care practices in New York City, Philadelphia, and Pittsburgh, USA, randomized to intervention or usual care. Participants 1226 participants...

  16. Personality disorder moderates outcome in short- and long-term group analytic psychotherapy: A randomized clinical trial.

    Science.gov (United States)

    Lorentzen, Steinar; Ruud, Torleif; Fjeldstad, Anette; Høglend, Per A

    2015-06-01

    In a randomized clinical trial, short- and long-term psychodynamic group psychotherapy (STG and LTG, respectively) schedules were equally effective for the 'typical' patient during a 3-year study period. Although several studies have reported good effects for patients with personality disorders (PD) in diverse forms of psychotherapy, the significance of treatment duration is unclear. Therefore, we tested the hypothesis that PD patients would improve more during and after LTG than STG. A randomized, longitudinal, prospective study contrasting the outcomes during and after short- and long-term dynamic group psychotherapies. One hundred and sixty-seven outpatients with mood disorders, anxiety disorders, or PD were randomized to STG or LTG (respectively, 20 or 80 weekly sessions of 90 min each). Outcome measures are as follows: symptoms (SCL-90-R), interpersonal problems (IIP-C), and psychosocial functioning (GAF split version: GAF-Symptom and GAF-Function). PD pathology (number of PD criteria items) was selected a priori as a putative moderator of treatment effects. Change during the 3-year study period was assessed using linear mixed models. The study was registered at ClinicalTrials.gov as NCT 00021417. Our hypothesis was supported, as patients with PD improved significantly more regarding all outcome variables in LTG than STG. For patients without PD, the rate of change was similar across 3 years; however, the rate of change in symptoms and interpersonal problems was higher in STG during the first 6 months. The effectiveness of LTG is higher for patients with co-morbid PD. Patients without PD do not appear to experience additional gain from LTG. Clinical implications: LTG demonstrates better effectiveness than STG for patients with personality disorder co-morbidity (PD). Patients without PD do not appear to experience additional gain from attending LTG. Correct initial allocation to treatment duration may prevent disruptive breaks in relationships and lead to both

  17. Long-term Mechanical Circulatory Support System reliability recommendation by the National Clinical Trial Initiative subcommittee.

    Science.gov (United States)

    Lee, James

    2009-01-01

    The Long-Term Mechanical Circulatory Support (MCS) System Reliability Recommendation was published in the American Society for Artificial Internal Organs (ASAIO) Journal and the Annals of Thoracic Surgery in 1998. At that time, it was stated that the document would be periodically reviewed to assess its timeliness and appropriateness within 5 years. Given the wealth of clinical experience in MCS systems, a new recommendation has been drafted by consensus of a group of representatives from the medical community, academia, industry, and government. The new recommendation describes a reliability test methodology and provides detailed reliability recommendations. In addition, the new recommendation provides additional information and clinical data in appendices that are intended to assist the reliability test engineer in the development of a reliability test that is expected to give improved predictions of clinical reliability compared with past test methods. The appendices are available for download at the ASAIO journal web site at www.asaiojournal.com.

  18. Long-term scar quality after hydrosurgical versus conventional debridement of deep dermal burns (HyCon trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Legemate, Catherine M; Goei, Harold; Middelkoop, Esther; Oen, Irma M M H; Nijhuis, Tim H J; Kwa, Kelly A A; van Zuijlen, Paul P M; Beerthuizen, Gerard I J M; Nieuwenhuis, Marianne K; van Baar, Margriet E; van der Vlies, Cornelis H

    2018-04-19

    Deep dermal burns require tangential excision of non-viable tissue and skin grafting to improve wound healing and burn-scar quality. Tangential excision is conventionally performed with a knife, but during the last decade hydrosurgery has become popular as a new tool for tangential excision. Hydrosurgery is generally thought to be a more precise and controlled manner of burn debridement leading to preservation of viable tissue and, therefore, better scar quality. Although scar quality is considered to be one of the most important outcomes in burn surgery today, no randomized controlled study has compared the effect of these two common treatment modalities with scar quality as a primary outcome. The aim of this study is, therefore, to compare long-term scar quality after hydrosurgical versus conventional tangential excision in deep dermal burns. A multicenter, randomized, intra-patient, controlled trial will be conducted in the Dutch burn centers of Rotterdam, Beverwijk, and Groningen. All patients with deep dermal burns that require excision and grafting are eligible. Exclusion criteria are: a burn wound burned > 30%, full-thickness burns, chemical or electrical burns, infected wounds (clinical symptoms in combination with positive wound swabs), insufficient knowledge of the Dutch or English language, patients that are unlikely to comply with requirements of the study protocol and follow-up, and patients who are (temporarily) incompetent because of sedation and/or intubation. A total of 137 patients will be included. Comparable wound areas A and B will be appointed, randomized and either excised conventionally with a knife or with the hydrosurgery system. The primary outcome is scar quality measured by the observer score of the Patient and Observer Scar Assessment Scale (POSAS); a subjective scar-assessment instrument, consisting of two separate six-item scales (observer and patient) that are both scored on a 10-point rating scale. This study will contribute to

  19. Simulating soil greenhouse emissions from Swiss long-term cropping system trials

    Science.gov (United States)

    Necpalova, Magdalena; Lee, Juhwan; Skinner, Colin; Büchi, Lucie; Berner, Alfred; Mäder, Paul; Mayer, Jochen; Charles, Raphael; van der Heijden, Marcel; Wittwer, Raphael; Gattinger, Andreas; Six, Johan

    2017-04-01

    There is an urgent need to identify and evaluate management practices for their bio-physical potential to mitigate greenhouse gas (GHG) emissions from agriculture. The cost and time required for direct management-specific GHG measurements limit the spatial and temporal resolution and the extent of data that can be collected. Biogeochemical process-based models such as DayCent can be used to bridge data gaps over space and time and estimate soil GHG emissions relevant to various climate change mitigation strategies. Objectives of this study were (a) to parameterize DayCent for common Swiss crops and crop-specific management practices using the Swiss long-term experimental data collected at four sites (Therwil, Frick, Changins, and Reckenholz); (b) to evaluate the model's ability to predict crop productivity, long-term soil carbon dynamics and N2O emissions from Swiss cropping systems; (c) to calculate a net soil GHG balance for all treatments (except for bio-dynamic) studied in long-term field experiments in Switzerland; and (d) to study the management effects and their interactions on soil GHG emissions at each experimental site. Model evaluation indicated that DayCent predicted crop productivity (rRMSE=0.29 r2=0.81, n=2614), change in soil carbon stock (rRMSE=0.14, r2=0.72, n=1289) and cumulative N2O emissions (rRMSE=0.25, r2=0.89, n=8) satisfactorily across all treatments and sites. Net soil GHG emissions were derived from changes in soil carbon, N2O emissions and CH4 oxidation on an annual basis using IPCC (2014) global warming potentials. Modelled net soil GHG emissions calculated for individual treatments over 30 years ranged from -594 to 1654 kg CO2 eq ha-1 yr-1. The highest net soil GHG emissions were predicted for conventional tillage and slurry application treatment at Frick, while soils under organic and reduced tillage management at Reckenholz acted as a net GHG sink. The statistical analyses using linear MIXED models indicated that net soil GHG

  20. Dor Vs Toupet Fundoplication After Laparoscopic Heller Myotomy: Long-Term Randomized Controlled Trial Evaluated by High-Resolution Manometry.

    Science.gov (United States)

    Torres-Villalobos, Gonzalo; Coss-Adame, Enrique; Furuzawa-Carballeda, Janette; Romero-Hernández, Fernanda; Blancas-Breña, Blanca; Torres-Landa, Samuel; Palacios-Ramírez, Axel; Alejandro-Medrano, Edgar; Hernández-Ávila, Axel; Flores-Najera, Athenea; Ávila Escobedo, Lourdes Margarita; Ramírez Angulo, Cecilia; Rodríguez-Garcés, Angélica; Valdovinos, Miguel Ángel

    2018-01-01

    Laparoscopic Heller myotomy (LHM) with partial fundoplication is an effective treatment for achalasia. However, the type of fundoplication is still a subject of debate. The aim of the study is to identify which partial fundoplication leads to better control of acid exposure, manometric parameters, and symptoms scores. A randomized controlled trial was performed to compare Dor vs Toupet fundoplication after LHM. The preoperative diagnosis was made by high-resolution manometry (HRM), upper endoscopy, and barium esophagogram. Preoperative and postoperative symptoms were evaluated with Eckardt, GERD-HRQL, and EAT-10 questionnaires. Seventy-three patients were randomized, 38 underwent Dor and 35 Toupet. Baseline characteristics were similar between groups. Postoperative HRM showed that the integrated relaxation pressure (IRP) and basal lower esophageal sphincter (LES) pressure were similar at 6 and 24 months. The number of patients with abnormal acid exposure was significantly lower for Dor (6.9%) than that of Toupet (34.0%) at 6 months, but it was not different at 12 or 24 months. No differences were found in postoperative symptom scores at 1, 6, or 24 months. There were no differences in symptom scores or HRM between fundoplications in the long term. A higher percentage of abnormal 24-h pH test were found for the Toupet group, with no difference in the long term.

  1. Long-term changes in ADAS-cog: what is clinically relevant for disease modifying trials in Alzheimer?

    Science.gov (United States)

    Vellas, B; Andrieu, S; Cantet, C; Dartigues, J F; Gauthier, S

    2007-01-01

    With the development of long-term disease modifying trials, changes in ADAS-Cog at 18 months will rise certainly many questions. We decided to look in the Real.fr study at the links between changes in cognition, ADAS-Cog and function. A total of 346 Alzheimer's patients with ADAS-cog at entry and at 18 months. were eligible for this analysis. These patients were on average 77.44 years old and 254 (72.36%) were women. The great majority lived at home and about 93% were treated with a cholinesterase inhibitor at baseline. Thirty three patients (9%) had a gain of more than 2 points at the ADAS-cog at 18 months (Group I, improvement); 130 (38%) were considered as stable, the reference group (Group II ) characterized by a stability at the ADAS-cog: decline of 2 points to gain of 2 points, 112 subjects (32%) had a moderate decline between 2 and 7 at the ADAScog (Group III) and finally 71 subjects (21%) had a severe impairment more than seven points at the ADAS-cog. A loss of one Basic ADL is certainly highly relevant, and such a change was found at 18 months in more than half of the subjects, which is not surprising for a long-term evolution in mild to moderate AD. An impairment of more than 7 points at the ADAS-cog was found in 21% of the subjects at 18 months and was associated with loss.

  2. Effect of whey protein supplementation on long and short term appetite: A meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Mollahosseini, Mehdi; Shab-Bidar, Sakineh; Rahimi, Mohammad Hossein; Djafarian, Kurosh

    2017-08-01

    Specific components of dairy, such as whey proteins may have beneficial effects on body composition by suppressing appetite, although the findings of existing studies have been inconsistent. Therefore, a meta-analysis of randomized controlled trials was performed to investigate effect of whey protein supplementation on long and short term appetite. A systematic search was conducted to identify eligible publications. Means and SDs for hunger, fullness, satiety, desire to eat and prospective consumption of food, before and after intervention, were extracted and then composite appetite score (CAS) calculated. To pool data, either a fixed-effects model or a random-effects model and for assessing heterogeneity, Cochran's Q and I 2 tests were used. Eight publications met inclusion criteria that 5 records were on short term and 3 records on long term appetite. The meta-analysis showed a significant reduction in long term appetite by 4.13 mm in combined appetite score (CAS) (95% Confidence interval (CI): -6.57, -1.96; p = 0.001). No significant reduction in short term appetite was also seen (Mean difference (MD) = -0.39 95% CI = -2.07, 1.30; p = 0.653). Subgroup analyses by time showed that compared with carbohydrate, the reduction in appetite following consumption of whey consumption was not significant (MD = -0.39, 95% CI = -2.07, 1.3, p = 0.65, I 2  = 0.0%.)A significant reduction in prospective food consumption was seen (MD = -2.17, 95% CI = -3.86, -0.48). The results of our meta-analysis showed that whey protein may reduce the long and short term appetite, but our finding did not show any significant difference in appetite reduction between whey protein and carbohydrate in short duration. Copyright © 2017 European Society for Clinical Nutrition and Metabolism. Published by Elsevier Ltd. All rights reserved.

  3. Effectiveness and short-term safety of modified sodium hyaluronic acid-carboxymethylcellulose at cesarean delivery: a randomized trial.

    Science.gov (United States)

    Kiefer, Daniel G; Muscat, Jolene C; Santorelli, Jarrett; Chavez, Martin R; Ananth, Cande V; Smulian, John C; Vintzileos, Anthony M

    2016-03-01

    The rising cesarean birth rate has drawn attention to risks associated with repeat cesarean birth. Prevention of adhesions with adhesion barriers has been promoted as a way to decrease operative difficulty. However, robust data demonstrating effectiveness of such interventions are lacking. We report data from a multicenter trial designed to evaluate the short-term safety and effectiveness of a modified sodium hyaluronic acid (HA)-carboxymethylcellulose (CMC) absorbable adhesion barrier for reduction of adhesions following cesarean delivery. Patients who underwent primary or repeat cesarean delivery were included in this multicenter, single-blinded (patient), randomized controlled trial. Patients were randomized into either HA-CMC (N = 380) or no treatment (N = 373). No other modifications to their treatment were part of the protocol. Short-term safety data were collected following randomization. The location and density of adhesions (primary outcome) were assessed at their subsequent delivery using a validated tool, which can also be used to derive an adhesion score that ranges from 0-12. No differences in baseline characteristics, postoperative course, or incidence of complications between the groups following randomization were noted. Eighty patients from the HA-CMC group and 92 controls returned for subsequent deliveries. Adhesions in any location were reported in 75.6% of the HA-CMC group and 75.9% of the controls (P = .99). There was no significant difference in the median adhesion score; 2 (range 0-10) for the HA-CMC group vs 2 (range 0-8) for the control group (P = .65). One third of the HA-CMC patients met the definition for severe adhesions (adhesion score >4) compared to 15.5% in the control group (P = .052). There were no significant differences in the time from incision to delivery (P = .56). Uterine dehiscence in the next pregnancy was reported in 2 patients in HA-CMC group vs 1 in the control group (P = .60). Although we did not identify any short-term

  4. Long-Term Pioglitazone Treatment for Patients With Nonalcoholic Steatohepatitis and Prediabetes or Type 2 Diabetes Mellitus: A Randomized Trial.

    Science.gov (United States)

    Cusi, Kenneth; Orsak, Beverly; Bril, Fernando; Lomonaco, Romina; Hecht, Joan; Ortiz-Lopez, Carolina; Tio, Fermin; Hardies, Jean; Darland, Celia; Musi, Nicolas; Webb, Amy; Portillo-Sanchez, Paola

    2016-09-06

    The metabolic defects of nonalcoholic steatohepatitis (NASH) and prediabetes or type 2 diabetes mellitus (T2DM) seem to be specifically targeted by pioglitazone. However, information about its long-term use in this population is limited. To determine the efficacy and safety of long-term pioglitazone treatment in patients with NASH and prediabetes or T2DM. Randomized, double-blind, placebo-controlled trial. (ClinicalTrials.gov: NCT00994682). University hospital. Patients (n = 101) with prediabetes or T2DM and biopsy-proven NASH were recruited from the general population and outpatient clinics. All patients were prescribed a hypocaloric diet (500-kcal/d deficit from weight-maintaining caloric intake) and then randomly assigned to pioglitazone, 45 mg/d, or placebo for 18 months, followed by an 18-month open-label phase with pioglitazone treatment. The primary outcome was a reduction of at least 2 points in the nonalcoholic fatty liver disease activity score in 2 histologic categories without worsening of fibrosis. Secondary outcomes included other histologic outcomes, hepatic triglyceride content measured by magnetic resonance and proton spectroscopy, and metabolic parameters. Among patients randomly assigned to pioglitazone, 58% achieved the primary outcome (treatment difference, 41 percentage points [95% CI, 23 to 59 percentage points]) and 51% had resolution of NASH (treatment difference, 32 percentage points [CI, 13 to 51 percentage points]) (P < 0.001 for each). Pioglitazone treatment also was associated with improvement in individual histologic scores, including the fibrosis score (treatment difference, -0.5 [CI, -0.9 to 0.0]; P = 0.039); reduced hepatic triglyceride content from 19% to 7% (treatment difference, -7 percentage points [CI, -10 to -4 percentage points]; P < 0.001); and improved adipose tissue, hepatic, and muscle insulin sensitivity (P < 0.001 vs. placebo for all). All 18-month metabolic and histologic improvements persisted over 36 months of

  5. [Long-term therapy of osteoarthritis of the hip and the knee by sulindac (a cooperative trial in general practice) (author's transl)].

    Science.gov (United States)

    Maestracci, D; Sarre, J

    Long-term trial of sulindac (in general practice): 2,040 patients with osteoarthritis of the hip or of the knee been treated, 86,5% of them have been following the treatment for one year. This trial let us pointing out the non-improverishment of effectiveness of sulindac and the keepint of its good tolerance for long term. Some epidemiological data have been collected, among which: the importance of ponderal overload in patients studied and the prevalence of the right joints diseases on the left one's.

  6. Short term effects of kinesiotaping on acromiohumeral distance in asymptomatic subjects: a randomised controlled trial.

    Science.gov (United States)

    Luque-Suarez, A; Navarro-Ledesma, S; Petocz, P; Hancock, M J; Hush, J

    2013-12-01

    The first aim of this study was to investigate whether kinesiotaping (KT) can increase the acromiohumeral distance (AHD) in asymptomatic subjects in the short term. The second aim was to investigate whether the direction of kinesiotaping application influences AHD. In recent years, the use of KT has become increasingly popular for a range of musculoskeletal conditions and for sport injuries. To date, we are unaware of any research investigating the effect of kinesiotaping on AHD. Moreover, it is unknown whether the direction of kinesiotaping application for the shoulder is important. Forty nine participants were randomly assigned to one of three groups: kinesiotaping group 1 (KT1), kinesiotaping group 2 (KT2) and sham kinesiotaping (KT3). AHD ultrasound measurements at 0° and 60° of shoulder elevation were collected at baseline and immediately after kinesiotape application. The results showed significant improvements in AHD after kinesiotaping, compared with sham taping. The mean difference in AHD between KT1 and KT3 groups was 1.28 mm (95% CI: 0.55, 2.03), and between KT2 and KT3 was 0.98 mm (95% CI: 0.23, 1.74). Comparison of KT1 and KT2 groups, which was performed to identify whether the direction of taping influences the AHD, indicated there were no significant differences. KT increases AHD in healthy individuals immediately following application, compared with sham kinesiotape. No differences were found with respect to the direction in which KT was applied. Copyright © 2013 Elsevier Ltd. All rights reserved.

  7. Peri-apatite coating decreases uncemented tibial component migration: long-term RSA results of a randomized controlled trial and limitations of short-term results.

    Science.gov (United States)

    Van Hamersveld, Koen T; Marang-Van De Mheen, Perla J; Nelissen, Rob G H H; Toksvig-Larsen, Sören

    2018-05-09

    Background and purpose - Biological fixation of uncemented knee prostheses can be improved by applying hydroxyapatite coating around the porous surface via a solution deposition technique called Peri-Apatite (PA). The 2-year results of a randomized controlled trial, evaluating the effect of PA, revealed several components with continuous migration in the second postoperative year, particularly in the uncoated group. To evaluate whether absence of early stabilization is diagnostic of loosening, we now present long-term follow-up results. Patients and methods - 60 patients were randomized to PA-coated or uncoated (porous only) total knee arthroplasty of which 58 were evaluated with radiostereometric analysis (RSA) performed at baseline, at 3 months postoperatively and at 1, 2, 5, 7, and 10 years. A linear mixed-effects model was used to analyze the repeated measurements. Results - PA-coated components had a statistically significantly lower mean migration at 10 years of 0.94 mm (95% CI 0.72-1.2) compared with the uncoated group showing a mean migration of 1.72 mm (95% CI 1.4-2.1). Continuous migration in the second postoperative year was seen in 7 uncoated components and in 1 PA-coated component. All of these implants stabilized after 2 years except for 2 uncoated components. Interpretation - Peri-apatite enhances stabilization of uncemented components. The number of components that stabilized after 2 years emphasizes the importance of longer follow-up to determine full stabilization and risk of loosening in uncemented components with biphasic migration profiles.

  8. Long-Term Efficacy of Maintenance Therapy for Multiple Myeloma: A Quantitative Synthesis of 22 Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    Jie-Li Li

    2018-04-01

    Full Text Available We aimed to quantitatively synthesize data from randomized controlled trials (RCTs concerning maintenance for multiple myeloma (MM. We searched electronic literature databases and conference proceedings to identify relevant RCTs. We selected eligible RCTs using predefined selection criteria. We conducted meta-analysis comparing maintenance containing new agents and conventional maintenance, and subgroup analysis by transplantation status and mainstay agent as well. We performed trial sequential analysis (TSA to determine adequacy of sample size for overall and subgroup meta-analyses. We performed network meta-analysis (NMA to compare and rank included regimens. A total of 22 RCTs involving 9,968 MM patients and 15 regimens were included, the overall quality of which was adequate. Significant heterogeneity was detected for progression-free survival (PFS but not overall survival (OS. Meta-analyses showed that maintenance containing new agents significantly improved PFS but not OS [PFS: Hazard Ratio (HR = 0.59, 95% Confidence Interval (CI = 0.54 to 0.64; OS: HR = 0.93, 95% CI = 0.87 to 1.00], compared with controls. Subgroup analyses revealed lenalidomide (Len-based therapies better than thalidomide-based ones (HR = 0.50 and 0.66, respectively; P = 0.001. NMA revealed that most of the maintenance regimens containing new agents were significantly better than simple observation in terms of PFS but not OS. Len single agent was the most effective, considering PFS and OS both. We concluded that conventional maintenance has very limited effect. Maintenance containing new agents is highly effective in improving PFS, but has very limited effect on OS. Maintenance with Len may have the largest survival benefits. Emerging strategies may further change the landscape of maintenance of MM.

  9. Improving the care of people with long-term conditions in primary care: protocol for the ENHANCE pilot trial

    Directory of Open Access Journals (Sweden)

    Emma L. Healey

    2015-12-01

    Full Text Available Background: Long-term conditions (LTCs are important determinants of quality of life and healthcare expenditure worldwide. Whilst multimorbidity is increasingly the norm in primary care, clinical guidelines and the delivery of care remain focused on single diseases, resulting in poorer clinical outcomes. Osteoarthritis, and anxiety and/or depression frequently co-occur with other LTCs, yet are seldom prioritized by the patient or clinician, resulting in higher levels of disability, poorer prognosis, and increased healthcare costs. Objective: To examine the feasibility and acceptability of an integrated approach to LTC management, tackling the under-diagnosis and under-management of osteoarthritis-related pain and anxiety and/or depression in older adults with other LTCs in primary care. Design: The ENHANCE study is a pilot stepped-wedge cluster randomized controlled trial to test the feasibility and acceptability of a nurse-led ENHANCE LTC review consultation for identifying, assessing, and managing joint pain, and anxiety and/or depression in patients attending LTC reviews. Specific objectives (process evaluation and research outcomes will be achieved through a theoretically informed mixed-methods approach using participant self-reported questionnaires, a medical record review, an ENHANCE EMIS template, qualitative interviews, and audio recordings of the ENHANCE LTC review. Discussion: Success of the pilot trial will be measured against the level of the primary care team engagement, assessment of training delivery, and degree of patient recruitment and retention. Patient satisfaction and treatment fidelity will also be explored. ISRCTN registry number: 12154418. Journal of Comorbidity 2015;5(1:135–149

  10. Association of external cephalic version before term with late preterm birth.

    Science.gov (United States)

    Poole, Kristie L; McDonald, Sarah D; Griffith, Lauren E; Hutton, Eileen K

    2017-08-01

    While evidence suggests that beginning an external cephalic version (ECV) before term (34 0/7 to 36 6/7 weeks) compared with after term may be associated with an increase in late preterm birth (34 0/7 to 36 6/7 weeks), it remains unknown what might account for this risk. The objective of the present study is to further investigate the association between ECV before term and late preterm birth. Secondary analysis of data collected from the international, multicenter Early ECV trials. We evaluated the relation between ECV exposure and late preterm birth (34 0/7 to 36 6/7 weeks), as well as whether additional risk factors for preterm birth (such as maternal age, height, body mass index, parity, placental location, and perinatal mortality rate) moderated this relation. Generalized linear mixed methods were used to account for center effect and adjust for covariates. Among 1765 women with breech pregnancies and without a prior preterm birth, 749 (42.4%) received at least one ECV before term. Exposure to an ECV before term was not associated significantly independently with odds of preterm birth. However, placenta location moderated the association between early ECV exposure and late preterm birth. The odds of preterm birth in women who were exposed to an ECV before term and who also had an anterior placenta were doubled (OR 2.05; 95% CI 1.12-3.71; p = 0.02). In a large cohort of women without known risks for preterm birth, those with an anterior placenta who undergo an ECV before term constitute a subgroup at particular risk for late preterm birth. © 2017 Nordic Federation of Societies of Obstetrics and Gynecology.

  11. Long-term antibiotics for prevention of recurrent urinary tract infection in older adults: systematic review and meta-analysis of randomised trials.

    Science.gov (United States)

    Ahmed, Haroon; Davies, Freya; Francis, Nick; Farewell, Daniel; Butler, Christoper; Paranjothy, Shantini

    2017-05-29

    To address clinical uncertainties about the effectiveness and safety of long-term antibiotic therapy for preventing recurrent urinary tract infections (UTIs) in older adults. Systematic review andmeta-analysis of randomised trials. We searched Medline, Embase, The Cumulative Index to Nursing and Allied Health Literature( CINAHL), and the Cochrane Register of Controlled Trials from inception to August 2016. Eligible studies compared long-term antibiotic therapy with non-antibiotic therapy or placebo in men or women aged over 65, or in postmenopausal women, with recurrent UTIs. We did not identify any studies that included older men. Three randomised controlled trials compared long-term antibiotics with vaginal oestrogens (n=150), oral lactobacilli (n=238) and D-mannose powder (n=94) in postmenopausal women. Long-term antibiotics reduced the risk of UTI recurrence by 24% (three trials, n=482; pooled risk ratio (RR) 0.76; 95% CI 0.61 to 0.95, number needed to treat=8.5). There was no statistically significant increase in risk of adverse events (mild adverse events: pooled RR 1.52; 95% CI 0.76 to 3.03; serious adverse events: pooled RR 0.90, 95% CI 0.31 to 2.66). One trial showed 90% of urinary and faecal Escherichia coli isolates were resistant to trimethoprim-sulfamethoxazole after 1 month of prophylaxis. Findings from three small trials with relatively short follow-up periods suggest long-term antibiotic therapy reduces the risk of recurrence in postmenopausal women with recurrent UTI. We did not identify any evidence to inform several clinically important scenarios including, benefits and harms in older men or frail care home residents, optimal duration of prophylaxis, recurrence rates once prophylaxis stops and effects on urinary antibiotic resistance. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  12. The effects of short-term alpha-ketoisocaproic acid supplementation on exercise performance: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Yarrow Joshua F

    2007-07-01

    Full Text Available Abstract Background This study examined the efficacy of short-term alpha-ketoisocaproic acid (KIC monotherapy supplementation immediately prior to moderate- and high-intensity single bout exercise performance. Methods Thirteen resistance trained men (22.8 ± 2.5 years; 81.6 ± 12.6 kg participated in a prospective, randomized, double blind, placebo controlled crossover experiment. Each subject completed one familiarization and four experimental trials with either 1.5 g or 9.0 g of either KIC or isocaloric placebo control (CONT, following an overnight fast. During the experimental trials, subjects consumed the supplement regimen and then completed leg and chest press repetitions to failure and 30 s of repeated maximal vertical jumping (VJ on a force plate. Results In this treatment regimen, no significant differences (p > 0.05 were observed between dosages or conditions for leg press (low CONT = 19.8 ± 0.4 SEM, low KIC = 21.0 ± 0.5, high CONT = 20.1 ± 0.3, high KIC = 22.4 ± 0.6 or chest press (low CONT = 18.1 ± 0.2, low KIC = 18.5 ± 0.3, high CONT = 17.8 ± 0.3, high KIC = 18.0 ± 0.3 repetitions to failure. Additionally, no significant differences were observed for peak or mean VJ performance (low CONT = 34.6 ± 2.2 cm and 28.6 ± 1.8 cm; low KIC = 35.6 ± 2.0 cm and 29.4 ± 1.6 cm; high CONT = 35.7 ± 2.1 cm and 29.4 ± 1.7 cm; high KIC = 34.8 ± 2.3 cm and 28.3 ± 1.7 cm, respectively. Conclusion Based on our results, we conclude that acute KIC ingestion by itself with no other ergogenic supplement, immediately prior to exercise, did not alter moderate- nor high-intensity single-bout exercise performance in young resistance-trained males. This study addressed single-dose single-bout performance events; the efficacy of KIC monotherapy supplementation on repeated high-intensity exercise bouts and long-term exercise training remains unknown.

  13. Pressure ulcer multidisciplinary teams via telemedicine: a pragmatic cluster randomized stepped wedge trial in long term care.

    Science.gov (United States)

    Stern, Anita; Mitsakakis, Nicholas; Paulden, Mike; Alibhai, Shabbir; Wong, Josephine; Tomlinson, George; Brooker, Ann-Sylvia; Krahn, Murray; Zwarenstein, Merrick

    2014-02-24

    The study was conducted to determine the clinical and cost effectiveness of enhanced multi-disciplinary teams (EMDTs) vs. 'usual care' for the treatment of pressure ulcers in long term care (LTC) facilities in Ontario, Canada We conducted a multi-method study: a pragmatic cluster randomized stepped-wedge trial, ethnographic observation and in-depth interviews, and an economic evaluation. Long term care facilities (clusters) were randomly allocated to start dates of the intervention. An advance practice nurse (APN) with expertise in skin and wound care visited intervention facilities to educate staff on pressure ulcer prevention and treatment, supported by an off-site hospital based expert multi-disciplinary wound care team via email, telephone, or video link as needed. The primary outcome was rate of reduction in pressure ulcer surface area (cm2/day) measured on before and after standard photographs by an assessor blinded to facility allocation. Secondary outcomes were time to healing, probability of healing, pressure ulcer incidence, pressure ulcer prevalence, wound pain, hospitalization, emergency department visits, utility, and cost. 12 of 15 eligible LTC facilities were randomly selected to participate and randomized to start date of the intervention following the stepped wedge design. 137 residents with a total of 259 pressure ulcers (stage 2 or greater) were recruited over the 17 month study period. No statistically significant differences were found between control and intervention periods on any of the primary or secondary outcomes. The economic evaluation demonstrated a mean reduction in direct care costs of $650 per resident compared to 'usual care'. The qualitative study suggested that onsite support by APN wound specialists was welcomed, and is responsible for reduced costs through discontinuation of expensive non evidence based treatments. Insufficient allocation of nursing home staff time to wound care may explain the lack of impact on healing

  14. QUALITY-OF-LIFE IN A LONG-TERM MULTICENTER TRIAL IN CHRONIC NONSPECIFIC LUNG-DISEASE - ASSESSMENT AT BASE-LINE

    NARCIS (Netherlands)

    KAPTEIN, AA; BRAND, PLP; DEKKER, FW; KERSTJENS, HAM; POSTMA, DS; SLUITER, HJ

    1993-01-01

    Quality-of-life (QOL) in patients with respiratory illness is a topic of increasing interest to clinicians and researchers. In a multicentre trial, which studies the long-term effects of three medication regimens (beta-agonist plus either placebo, anti-cholinergic agent or corticosteroid, all by

  15. Cost-effectiveness of a long-term Internet-delivered worksite health promotion programme on physical activity and nutrition: A cluster randomized controlled trial

    NARCIS (Netherlands)

    S.J.W. Robroek (Suzan); S. Polinder (Suzanne); F.J. Bredt (Folef); A. Burdorf (Alex)

    2012-01-01

    textabstractThis study aims to evaluate the cost-effectiveness of a long-term workplace health promotion programme on physical activity (PA) and nutrition. In total, 924 participants enrolled in a 2-year cluster randomized controlled trial, with departments (n = 74) within companies (n = 6) as the

  16. The Long-Term Effectiveness of a Selective, Personality-Targeted Prevention Program in Reducing Alcohol Use and Related Harms: A Cluster Randomized Controlled Trial

    Science.gov (United States)

    Newton, Nicola C.; Conrod, Patricia J.; Slade, Tim; Carragher, Natacha; Champion, Katrina E.; Barrett, Emma L.; Kelly, Erin V.; Nair, Natasha K.; Stapinski, Lexine; Teesson, Maree

    2016-01-01

    Background: This study investigated the long-term effectiveness of Preventure, a selective personality-targeted prevention program, in reducing the uptake of alcohol, harmful use of alcohol, and alcohol-related harms over a 3-year period. Methods: A cluster randomized controlled trial was conducted to assess the effectiveness of Preventure.…

  17. The coping with depression course: Short term outcomes and mediating effects of a randomized controlled trial in the treatment of subclinical depression

    NARCIS (Netherlands)

    Allart-van Dam, E.; Hosman, C.M.H.; Hoogduin, C.A.L.; Schaap, C.P.D.R.

    2003-01-01

    This article reports on a randomized controlled trial investigating the short-term effectiveness of the Coping With Depression course in a sample of adults seriously at risk of developing major depression. In addition, possible mediating properties of several proximal outcome variables were

  18. The Coping with Depression course : Short-term outcomes and mediating effects of a randomized controlled trial in the treatment of subclinical depression

    NARCIS (Netherlands)

    Allart-van Dam, E; Hosman, CMH; Hoogduin, CAL; Schaap, CPDR

    2003-01-01

    This article reports on a randomized controlled trial investigating the short-term effectiveness of the Coping With Depression course in a sample of adults seriously at risk of developing major depression. In addition, possible mediating properties of several proximal outcome variables were

  19. Is a long-term high-intensity exercise program effective and safe in patients with rheumatoid arthritis? Results of a randomized controlled trial

    NARCIS (Netherlands)

    de Jong, Zuzana; Munneke, Marten; Zwinderman, Aeilko H.; Kroon, Herman M.; Jansen, Annemarie; Ronday, Karel H.; van Schaardenburg, Dirkjan; Dijkmans, Ben A. C.; van den Ende, Cornelia H. M.; Breedveld, Ferdinand C.; Vliet Vlieland, Theodora P. M.; Hazes, Johanna M. W.

    2003-01-01

    OBJECTIVE: There are insufficient data on the effects of long-term intensive exercise in patients with rheumatoid arthritis (RA). We undertook this randomized, controlled, multicenter trial to compare the effectiveness and safety of a 2-year intensive exercise program (Rheumatoid Arthritis Patients

  20. Is a long-term high-intensity exercise program effective and safe in patients with rheumatoid arthritis? Results of a randomized controlled trial.

    NARCIS (Netherlands)

    Jong, Z. de; Munneke, M.; Zwinderman, A.H.; Kroon, H.M.; Jansen, A.; Ronday, K.H.; Schaardenburg, D. van; Dijkmans, B.A.C.; Ende, C.H.M. van den; Breedveld, F.C.; Vliet Vlieland, T.P.M.; Hazes, J.M.W.

    2003-01-01

    OBJECTIVE: There are insufficient data on the effects of long-term intensive exercise in patients with rheumatoid arthritis (RA). We undertook this randomized, controlled, multicenter trial to compare the effectiveness and safety of a 2-year intensive exercise program (Rheumatoid Arthritis Patients

  1. Cost-Effectiveness of a Long-Term Internet-Delivered Worksite Health Promotion Programme on Physical Activity and Nutrition: A Cluster Randomized Controlled Trial

    Science.gov (United States)

    Robroek, Suzan J. W.; Polinder, Suzanne; Bredt, Folef J.; Burdorf, Alex

    2012-01-01

    This study aims to evaluate the cost-effectiveness of a long-term workplace health promotion programme on physical activity (PA) and nutrition. In total, 924 participants enrolled in a 2-year cluster randomized controlled trial, with departments (n = 74) within companies (n = 6) as the unit of randomization. The intervention was compared with a…

  2. A randomised trial of enteral glutamine supplementation for very preterm children showed no beneficial or adverse long-term neurodevelopmental outcomes

    NARCIS (Netherlands)

    Twilhaar, E.S.; de Kieviet, J.F.; Oosterlaan, J.; van Elburg, R.M.

    2017-01-01

    Aim This study evaluated the long-term effects of enteral glutamine supplementation on neurodevelopmental outcomes of a Dutch cohort of very preterm children at 13 years of age. Methods The cohort was enrolled in a randomised placebo-controlled trial between 2001 and 2003 in which infants received

  3. A randomised trial of enteral glutamine supplementation for very preterm children showed no beneficial or adverse long-term neurodevelopmental outcomes

    NARCIS (Netherlands)

    Twilhaar, E. Sabrina; de Kieviet, Jorrit F.; Oosterlaan, Jaap; van Elburg, Ruurd M.

    2017-01-01

    This study evaluated the long-term effects of enteral glutamine supplementation on neurodevelopmental outcomes of a Dutch cohort of very preterm children at 13 years of age. The cohort was enrolled in a randomised placebo-controlled trial between 2001-2003 in which infants received glutamine- or

  4. Recruiting long-term survivors of European Organisation for Research and Treatment of Cancer phase III clinical trials into quality of life studies : Challenges and opportunities

    NARCIS (Netherlands)

    van Leeuwen, M.L.; Efficace, F.; Fosså, S.D.; Bolla, M.; de Giorgi, U.; De Wit, R.; Holzner, B.; van de Poll-Franse, L.; White, J.; Collette, L.; Osanto, S.; Aaronson, N.K.; European Organisation for Research and Treatment of Cancer Quality of Life Group; Genito-Urinary Cancers Group, The

    2014-01-01

    Objectives In this pilot study we evaluated the feasibility of and methods for assessing the quality of life of long term survivors of European Organisation for Research and Treatment of Cancer (EORTC) phase III clinical trials. Here we report the results pertaining to the feasibility of conducting

  5. Recruiting long-term survivors of European Organisation for Research and Treatment of Cancer phase III clinical trials into quality of life studies: Challenges and opportunities

    NARCIS (Netherlands)

    van Leeuwen, M.; Efficace, F.; Fosså, S.D.; Bolla, M.; De Giorgi, U.; de Wit, R; Holzner, B.; van de Poll-Franse, L.V.; van Poppel, H.; White, J.; Collette, L.; Osanto, S.; Aaronson, N.K.

    2014-01-01

    Objectives: In this pilot study we evaluated the feasibility of and methods for assessing the quality of life of long term survivors of European Organisation for Research and Treatment of Cancer (EORTC) phase III clinical trials. Here we report the results pertaining to the feasibility of conducting

  6. Enriched enteral nutrition may improve short-term survival in stage IV gastric cancer patients: A randomized, controlled trial.

    Science.gov (United States)

    Klek, Stanislaw; Scislo, Lucyna; Walewska, Elzbieta; Choruz, Ryszard; Galas, Aleksander

    2017-04-01

    The aim of the study was to determine whether the postoperative use of enteral nutrition enriched with arginine, glutamine, and omega-3 fatty acids influences survival in patients diagnosed with stomach cancer. For the purpose of the study, the second wave of the trial performed in 2003 to 2009 was done. Ninety-nine patients who underwent surgery for gastric cancer (27 F, 72 M, mean age: 62.9 y) met the inclusion criteria. Of those, 54 were randomized to standard and 45 to enriched enteral nutrition (EEN). In all patients, short- and long-term (5 y) survival was analyzed. Analysis of the overall survival time did not reveal differences between groups (P = 0.663). Until the end of the third month, however, there were nine deaths in the standard enteral nutrition group and no deaths in the EEN group (16.7% versus 0.0%, P = 0.004). The univariate analyses suggested that the EEN group may have lower risk, especially during the first year after intervention. A significant reduction in the risk of death was seen during the early period after surgery (first 6 mo) in the EEN group in stage IV patients (hazard ratio = 0.25, P = 0.049). The use of enriched enteral diet did not influence, however, the risk of dying when patients were analyzed together. The study does not support the beneficial effect of enriched enteral nutrition in long-term survival; however, the positive impact on the stage IV patients suggests the need for further, more detailed studies. Copyright © 2016 Elsevier Inc. All rights reserved.

  7. Randomized controlled trial of laparoscopic Heller myotomy plus Dor fundoplication versus Nissen fundoplication for achalasia: long-term results.

    Science.gov (United States)

    Rebecchi, Fabrizio; Giaccone, Claudio; Farinella, Eleonora; Campaci, Roberto; Morino, Mario

    2008-12-01

    To compare in a prospective, randomized trial the long-term results of laparoscopic Heller myotomy plus Dor fundoplication versus laparoscopic Heller myotomy plus floppy-Nissen for achalasia. Anterior fundoplication is usually performed after Heller myotomy to control GER; however, the incidence of postoperative GER ranges between 10% and 30%. Total fundoplication may aid in reducing GER rates. From December 1993 to September 2002, 153 patients with achalasia underwent Heller laparoscopic myotomy plus antireflux fundoplication. Of these, 9 were excluded from the study. The remaining 144 patients were randomly assigned to 2 treatment groups: Heller laparoscopic myotomy plus anterior fundoplication (Dor procedure) or Heller laparoscopic myotomy plus total fundoplication (floppy-Nissen procedure). The primary end point was incidence of clinical and instrumental GER after a minimum of 60 months follow-up. The secondary end point was recurrence of dysphagia. Follow-up clinical assessments were performed at 1, 3, 12, and 60 months using a modified DeMeester Symptom Scoring System (MDSS). Esophageal manometry and 24-hour pH monitoring were performed at 3, 12, and 60 months postoperative. Of the 144 patients originally included in the study, 138 were available for long-term analysis: 71 (51%) underwent antireflux fundoplication plus a Dor procedure (H + D group) and 67 (49%) antireflux fundoplication plus a Nissen procedure (H + N group). No mortality was observed. The mean follow-up period was 125 months. No statistically significant differences in clinical (5.6% vs. 0%) or instrumental GER (2.8% vs. 0%) were found between the 2 groups; however, a statistically significant difference in dysphagia rates was noted (2.8% vs. 15%; P Heller myotomy.

  8. Portion controlled ready-to-eat meal replacement is associated with short term weight loss: a randomised controlled trial.

    Science.gov (United States)

    Kuriyan, Rebecca; Lokesh, Deepa P; D'Souza, Ninoshka; Priscilla, Divya J; Peris, Chandni Halcyon; Selvam, Sumithra; Kurpad, Anura V

    2017-01-01

    Strategies to prevent and treat overweight/obesity are urgently needed. This study assessed the effect of a short-term intake of ready-to-eat cereal on body weight and waist circumference of overweight/obese individuals in comparison to a control group. A randomized, controlled 2-arm trial was carried out on 101 overweight/obese (Body Mass Index - 29.2±2.4 kg/m2) females aged 18 to 44 years, at St. John's Medical College Hospital. The intervention group received a low fat, ready to eat cereal, replacing two meals/day for two weeks. The control group was provided with standard dietary guidelines for weight loss and energy requirements for both groups were calculated similarly. Anthropometric, dietary, appetite and health status assessments were carried out at baseline and at the end of two weeks. At the end of two weeks, the mean reductions in body weight and waist circumference were significantly greater in the intervention group, -0.53 kg; 95% CI (-0.86 to -0.19) for body weight and -1.39 cm; 95% CI (-1.78, -0.99) for waist circumference. The intervention group had a significantly higher increase in dietary intakes of certain vitamins, fiber and sugar, and significantly higher reductions in total and polyunsaturated fats and sodium intakes, as compared to the control group (peat cereal could be effective for short-term weight loss, with some improvements in the nutrient intake profile. However, studies of longer duration are needed.

  9. Short- and long-term effects of mud-bath treatment on hand osteoarthritis: a randomized clinical trial

    Science.gov (United States)

    Fioravanti, Antonella; Tenti, Sara; Giannitti, Chiara; Fortunati, Nicola Angelo; Galeazzi, Mauro

    2014-01-01

    The aim of this study was to evaluate both the short-term and the long-term effectiveness of spa therapy in patients with primary hand osteoarthritis (OA). This was a prospective randomized, single blind controlled trial. Sixty outpatients with primary bilateral hand OA were included in the study and randomized to one of two groups. One group ( n = 30) was treated with 12 daily local mud packs and generalized thermal baths with a sulfate-calcium-magnesium-fluorides mineral water added to usual treatment. The control group ( n = 30) continued regular outpatient care routine (exercise, NSAIDs and/or analgesics). Each patient was examined at baseline, after 2 weeks, and after 3, 6, 9 and 12 months. Primary outcome measures were global spontaneous hand pain on a visual analogue scale (VAS) and the functional index for hand osteoarthritis (FIHOA) score; secondary outcomes were health assessment questionnaire (HAQ), duration of morning stiffness, medical outcomes study 36-item short form (SF-36) and symptomatic drugs consumption. Our results demonstrated that the efficacy of spa therapy was significant in all the assessed parameters, both at the end of therapy and after 3 months; the values of FIHOA, HAQ and drugs consumption continued to be significantly better after 6 months in comparison with baseline. There were no significant modifications of the parameters throughout the follow-up in the control group. Differences between the two groups were significant for all parameters at the 15th day and at 3 months follow-up; regarding FIHOA, HAQ, and symptomatic drugs consumption, the difference between the two groups persisted and was significant at 6month follow-up. Tolerability of spa therapy seemed to be good. In conclusion, our results confirm that the beneficial effects of spa therapy in patients with hand OA last over time.

  10. Effects of a short-term parental education program on childhood atopic dermatitis: a randomized controlled trial.

    Science.gov (United States)

    Futamura, Masaki; Masuko, Ikuyo; Hayashi, Keiichi; Ohya, Yukihiro; Ito, Komei

    2013-01-01

    Parental education is important in managing childhood atopic dermatitis (AD). We evaluated the long-term effects of a 2-day parental education program (PEP) on childhood AD. In an investigator-blinded, randomized controlled trial, 59 children age 6 months to 6 years with moderate to severe AD and their mothers were recruited in Japan. Participants were given a booklet about AD and received conventional treatment alone or in combination with a 2-day PEP comprising three lectures, three practical sessions, and a group discussion. The primary outcome was evaluation of eczema severity using SCORing Atopic Dermatitis (SCORAD) at 6 months. Secondary outcomes included changes in symptom scores, amount of corticosteroid used, parental quality of life as determined according to the Dermatitis Family Impact questionnaire, and change in parental anxiety regarding the use of corticosteroids in their children. Participants in the PEP group had a significantly lower SCORAD score than those in the control group at 6 months (mean difference 10.0, 95% confidence interval [CI] = 2.3-17.7, p = 0.01) and objective SCORAD score (mean difference 7.1, 95% CI = 0.8-13.5, p = 0.03). The sleeplessness symptom score (mean difference 1.6, 95% CI = 0.0-3.1, p = 0.048) and corticosteroid anxiety score (p = 0.02) in the PEP group were significantly better than in the control group at 6 months. There was no significant difference between groups in the amount of corticosteroid used or quality of life. The PEP had positive long-term effects on eczema severity and parental anxiety about corticosteroid usage. © 2013 Wiley Periodicals, Inc.

  11. The Impact of Short-Term Video Games on Performance among Children with Developmental Delays: A Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Ru-Lan Hsieh

    Full Text Available This prospective, randomized controlled study investigated the effects of short-term interactive video game playing among children with developmental delays participating in traditional rehabilitation treatment at a rehabilitation clinic. One hundred and one boys and 46 girls with a mean age of 5.8 years (range: 3 to 12 years were enrolled in this study. All patients were confirmed to suffer from developmental delays, and were participating in traditional rehabilitation treatment. Children participated in two periods of 4 weeks each, group A being offered intervention of eight 30-minute sessions of interactive video games in the first period, and group B in the second, in addition to the traditional rehabilitation treatment. The physical, psychosocial, and total health of the children was periodically assessed using the parent-reported Pediatric Quality of Life Inventory-Generic Core Scales (PedsQL; and the children's upper extremity and physical function, transfer and basic mobility, sports and physical functioning, and global functioning were assessed using the Pediatric Outcomes Data Collection Instrument. Parental impact was evaluated using the PedsQL-Family Impact Module for family function, PedsQL-Health Satisfaction questionnaire for parents' satisfaction with their children's care and World Health Organization-Quality of Life-Brief Version for quality of life. Compared with the baseline, significant improvements of physical function were observed in both groups (5.6 ± 19.5, p = 0.013; 4.7 ± 13.8, p = 0.009 during the intervention periods. No significant improvement of psychosocial health, functional performance, or family impact was observed in children with developmental delays. Short-term interactive video game play in conjunction with traditional rehabilitation treatment improved the physical health of children with developmental delays.ClinicalTrials.gov NCT02184715.

  12. The Impact of Short-Term Video Games on Performance among Children with Developmental Delays: A Randomized Controlled Trial.

    Science.gov (United States)

    Hsieh, Ru-Lan; Lee, Wen-Chung; Lin, Jui-Hsiang

    2016-01-01

    This prospective, randomized controlled study investigated the effects of short-term interactive video game playing among children with developmental delays participating in traditional rehabilitation treatment at a rehabilitation clinic. One hundred and one boys and 46 girls with a mean age of 5.8 years (range: 3 to 12 years) were enrolled in this study. All patients were confirmed to suffer from developmental delays, and were participating in traditional rehabilitation treatment. Children participated in two periods of 4 weeks each, group A being offered intervention of eight 30-minute sessions of interactive video games in the first period, and group B in the second, in addition to the traditional rehabilitation treatment. The physical, psychosocial, and total health of the children was periodically assessed using the parent-reported Pediatric Quality of Life Inventory-Generic Core Scales (PedsQL); and the children's upper extremity and physical function, transfer and basic mobility, sports and physical functioning, and global functioning were assessed using the Pediatric Outcomes Data Collection Instrument. Parental impact was evaluated using the PedsQL-Family Impact Module for family function, PedsQL-Health Satisfaction questionnaire for parents' satisfaction with their children's care and World Health Organization-Quality of Life-Brief Version for quality of life. Compared with the baseline, significant improvements of physical function were observed in both groups (5.6 ± 19.5, p = 0.013; 4.7 ± 13.8, p = 0.009) during the intervention periods. No significant improvement of psychosocial health, functional performance, or family impact was observed in children with developmental delays. Short-term interactive video game play in conjunction with traditional rehabilitation treatment improved the physical health of children with developmental delays. ClinicalTrials.gov NCT02184715.

  13. Active intervention in patients with whiplash-associated disorders improves long-term prognosis: a randomized controlled clinical trial.

    Science.gov (United States)

    Rosenfeld, Mark; Seferiadis, Aris; Carlsson, Jane; Gunnarsson, Ronny

    2003-11-15

    Three-year follow-up of a prospective randomized trial in 97 patients exposed to whiplash trauma in motor vehicle collisions. To compare the long-term efficacy of active intervention with that of standard intervention and the effect of early versus delayed initiation of intervention. There is no strong evidence for many treatments for whiplash-associated disorders. Some studies provide weak evidence supporting active intervention. Patients were randomized to an intervention using frequent active cervical rotation complemented by assessment and treatment according to McKenzie's principles or to a standard intervention of initial rest, recommended soft collar, and gradual self-mobilization. To test the time factor, interventions were either made within 96 hours or delayed 14 days from collision. The effects of the two interventions and the time factor on pain intensity, cervical range of motion, and sick leave were analyzed at 6 months and 3 years. Cervical range of motion at 3 years was also compared with that in matched, unexposed individuals. Pain intensity and sick leave were significantly (P whiplash-associated disorders, active intervention is more effective in reducing pain intensity and sick leave, and in retaining/regaining total range of motion than a standard intervention. Active intervention can be carried out as home exercises initiated and supported by appropriately trained health professionals.

  14. Effect of long-term intranasal oxytocin on sexual dysfunction in premenopausal and postmenopausal women: a randomized trial.

    Science.gov (United States)

    Muin, Dana A; Wolzt, Michael; Marculescu, Rodrig; Sheikh Rezaei, Safoura; Salama, Mohamed; Fuchs, Carola; Luger, Anton; Bragagna, Elia; Litschauer, Brigitte; Bayerle-Eder, Michaela

    2015-09-01

    To assess the effect of on-demand intranasal oxytocin administration on female sexual function and activity. Randomized, prospective, double-blind, placebo-controlled, crossover trial with duration of 22 weeks. Academic medical center. Thirty pre-and postmenopausal women with sexual dysfunction. Over 8 weeks, intranasal oxytocin (32 IU) or placebo self-administered by women within 50 minutes before sexual intercourse; after a washout period of 2 weeks, crossover with patients switched to the alternate group for another 8 weeks. Primary outcome parameter: Female Sexual Function Index (FSFI); secondary outcome parameters: Female Sexual Distress Scale (FSDS), Sexual Quality of Life-Female (SQOL-F), Sexual Interest and Desire Inventory-Female (SIDI-F), and Hamilton depression scale (HDS). After oxytocin and placebo, the FSFI score increased by 26% and 31%, SQOL-F score by 144% and 125%, and SIDI-F score by 29% and 23%, respectively (repeated measures analysis of variance between groups). After oxytocin and placebo, the FSDS score decreased by 36% and 45%, respectively (repeated measures analysis of variance between groups). There was no statistically significant treatment, sequence (placebo first/second), or interaction effect. Long-term intranasal oxytocin and placebo administration both improved sexual function and symptoms of depression in women over time with no treatment, sequence (placebo first/second), or interaction effect. NCT02229721. Copyright © 2015 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  15. Impact of Vitamin D Supplementation on Gross Motor Development of Healthy Term Infants: A Randomized Dose-Response Trial.

    Science.gov (United States)

    Wicklow, Brandy; Gallo, Sina; Majnemer, Annette; Vanstone, Catherine; Comeau, Kathryn; Jones, Glenville; L'Abbe, Mary; Khamessan, Ali; Sharma, Atul; Weiler, Hope; Rodd, Celia

    2016-08-01

    In addition to benefits for bone health, vitamin D is implicated in muscle function in children and adults. To determine if vitamin D dosage positively correlated with gross motor development at 3 and 6 months of age. We hypothesized that higher doses would be associated with higher scores for gross motor skills. A consecutive sample of 55 healthy, term, and breastfed infants from Montreal, Canada were recruited from a randomized trial of vitamin D supplementation between 2009 and 2012. Infants were randomized to 400 International Units (IU) (n = 19), 800 IU (n = 18) or 1,200 IU (n = 18) vitamin D3/day. Motor performance at 3 and 6 months was quantified by the Alberta Infant Motor Scale (AIMS). Plasma vitamin D3 metabolites were measured by tandem mass spectrometry. AIMS scores did not differ at 3 months. However, total AIMS scores and sitting subscores were significantly higher at 6 months in infants receiving 400 IU/day compared to 800 IU/day and 1,200 IU/day groups (p gross motor achievements were significantly higher in infants receiving 400 IU/day vitamin D. Our findings also support longer infants being slightly delayed.

  16. Understanding the fate of black (pyrogenic) carbon in soil: Preliminary results from a long term field trial

    Science.gov (United States)

    Meredith, Will; Ascough, Philippa; Bird, Michael; Large, David; Shen, Licheng; Snape, Colin

    2014-05-01

    Black carbon (BC, also known as pyrogenic carbon) is an 'inert' form of carbon and has been proposed as a means of long-term carbon sequestration, particularly by amending soils and sediments with BC known as biochar. While there is abundant anecdotal evidence of biochar stability over extended timescales it is essential to gain a greater understanding of the degree and mechanisms of biochar degradation in the environment. This study aims to quantitatively assess the stability of biochar by investigating samples from field degradation trials first buried during 2009 in a tropical soil, and recovered after 12 and 36 month intervals. Catalytic hydropyrolysis (HyPy) is a novel analytical tool for the isolation of BC [1] in which high hydrogen pressure (150 bar) and a sulphided Mo catalyst reductively remove the non-BC fraction of the chars, and so isolate the most stable portion of the biochar, defined as BC(HyPy). This method also allows for the non-BC(HyPy) fraction of a sample, which from charcoal is known to include small ring PAHs (soil depth and pH to be investigated. Char stability (as measured by BC(HyPy) content) is dependent on both the feedstock and temperature of formation. HyPy is known to discriminate (in terms of BC isolation) against low temperature chars, composed of relatively small aromatic clusters [1], resulting in the low BC(HyPy) contents reported for the 305°C chars. Fresh charcoals, and those not subject to environmental degradation have display a similar distribution of aromatic clusters in the non-BC(HyPy) fraction, with 2 to 7 ring PAHs abundant [2]. However, environmentally degraded charcoals such as that from a Chinese river sediment, and an Australian river estuary [3] show a more restricted distribution with markedly fewer 2- and 3- ring PAH structures apparent. This may be evidence for the partial solubilisation of the charcoal as observed for a forest soil [4] and suggested as a mechanism for the transport of BC to the oceans [5

  17. Adherence and success in long-term weight loss diets: the dietary intervention randomized controlled trial (DIRECT).

    Science.gov (United States)

    Greenberg, Ilana; Stampfer, Meir J; Schwarzfuchs, Dan; Shai, Iris

    2009-04-01

    Data are limited as to whether participants in diet trials truly adhere to their assigned diet and the factors that affect their adherence. We evaluated success and adherence in a two-year dietary intervention randomized controlled trial (DIRECT) in which 322 moderately obese participants (mean age 52 yrs, mean body-mass-index (BMI) 31 kg/m(2), 86% men) were randomized to one of three groups: low-fat, Mediterranean, or low-carbohydrate diets. Overall compliance at month-24 was 85%, with 90% in low-fat, 85% in Mediterranean, and 78% in low-carbohydrate diet (p = .042 between groups). Attrition was higher in women (29% vs. 14% men, p = .001) and current smokers (25% vs. 14% among maintainers, p = 0.04). In a multivariate model, independent predictors of dropping-out were: higher baseline BMI (OR = 1.11; CI: 1.03-1.21) and less weight loss at month-6 (OR = 1.20; CI: 1.1-1.3). In a multivariate model, greater weight loss achieved at month-6 was the main predictor associated with success in weight loss (> 5%) over 2 years (OR = 1.5; CI: 1.35-1.67). Self-reported complete adherence score to diet was greater on low-carbohydrate diet (p low-fat) until month-6, but dropped overall from 81% at month-1 to 57% at month-24. Holidays were a trigger to a significant decrease in adherence followed by a partial rebound. Changes in diet composition from month-1 to month-12 were more pronounced in the multi-stage low-carbohydrate diet-group (p < .05). Generally, the most irresistible restricted food items were cookies (45% of dieters) and fruits (30%). Among the physically active (n = 107), 44% reported a tendency to eat less after exercising compared to 10% who tended to eat more. Initial 6-month reduction in weight is the main predictor of both long-term retention and success in weight loss. Special attention is needed for women, current smokers, and during holidays. Physical activity is associated with subsequent reduction in energy intake.

  18. Acute and Short-Term Toxicities of Conventionally Fractionated Versus Hypofractionated Whole Breast Irradiation in a Prospective, Randomized Trial

    Science.gov (United States)

    Shaitelman, Simona F.; Schlembach, Pamela J.; Arzu, Isidora; Ballo, Matthew; Bloom, Elizabeth S.; Buchholz, Daniel; Chronowski, Gregory M.; Dvorak, Tomas; Grade, Emily; Hoffman, Karen E.; Kelly, Patrick; Ludwig, Michelle; Perkins, George H.; Reed, Valerie; Shah, Shalin; Stauder, Michael C.; Strom, Eric A.; Tereffe, Welela; Woodward, Wendy A.; Ensor, Joe; Baumann, Donald; Thompson, Alastair M.; Amaya, Diana; Davis, Tanisha; Guerra, William; Hamblin, Lois; Hortobagyi, Gabriel; Hunt, Kelly K.; Buchholz, Thomas A.; Smith, Benjamin D.

    2015-01-01

    IMPORTANCE The most appropriate dose-fractionation for whole breast irradiation (WBI) remains uncertain. OBJECTIVE To assess acute and six-month toxicity and quality of life (QoL) with conventionally fractionated WBI (CF-WBI) versus hypofractionated WBI (HF-WBI). DESIGN Unblinded randomized trial of CF-WBI (n=149; 50 Gy/25 fractions + boost [10–14 Gy/5–7 fractions]) versus HF-WBI (n=138; 42.56 Gy/16 fractions + boost [10–12.5 Gy/4–5 fractions]). SETTING Community-based and academic cancer centers. PARTICIPANTS 287 women age ≥ 40 years with stage 0–II breast cancer treated with breast-conserving surgery for whom whole breast irradiation without addition of a third field was recommended. 76% (n=217) were overweight or obese. Patients were enrolled from February 2011 through February 2014. INTERVENTION(S) FOR CLINICAL TRIALS CF-WBI versus HF-WBI. MAIN OUTCOME MEASURES Physician-reported acute and six-month toxicities using NCICTCv4.0 and patient-reported QoL using the FACT-B version 4. All analyses were intention-to-treat, with outcomes compared using chi-square, Cochran-Armitage test, and ordinal logistic regression. Patients were followed for a minimum of 6 months. RESULTS Treatment arms were well-matched for baseline characteristics including FACT-B total score (P=0.46) and individual QoL items such as lack of energy (P=0.86) and trouble meeting family needs (P=0.54). Maximal physician-reported acute dermatitis (P<0.001), pruritus (P<0.001), breast pain (P=0.001), hyperpigmentation (P=0.002), and fatigue (P=0.02) during radiation were lower in patients randomized to HF-WBI. Overall grade ≥2 acute toxicity was less with HF-WBI vs. CF-WBI (47% vs. 78%; P<0.001). Six months after radiation, physicians reported less fatigue in patients randomized to HF-WBI (P=0.01), and patients randomized to HF-WBI reported less lack of energy (P<0.001) and less trouble meeting family needs (P=0.01). Multivariable regression confirmed the superiority of HF-WBI in terms

  19. Leisure-time activity is an important determinant of long-term weight maintenance after weight loss in the Sibutramine Trial on Obesity Reduction and Maintenance (STORM trial)

    DEFF Research Database (Denmark)

    van Baak, M. A.; van Mil, E.; Astrup, A.

    2003-01-01

    The success rate of long-term maintenance of weight loss in obese patients is usually low. To improve the success rate, determinants of long-term weight maintenance must be identified.......The success rate of long-term maintenance of weight loss in obese patients is usually low. To improve the success rate, determinants of long-term weight maintenance must be identified....

  20. Long-term survival in trial of medium-titre Edmonston-Zagreb measles vaccine in Guinea-Bissau

    DEFF Research Database (Denmark)

    Aaby, Peter; Lisse, Ida; Whittle, H

    1994-01-01

    A trial of protective efficacy which compared medium-titre Edmonston-Zagreb (EZ) measles vaccine (10(4.6) p.f.u.) from the age of 4 months with the standard Schwarz (SW) measles vaccine given from the age of 9 months was started in an urban community in Guinea-Bissau in 1985. Because trials of high...

  1. Medium-term effectiveness of online behavioral training in migraine self-management: A randomized trial controlled over 10 months.

    Science.gov (United States)

    Sorbi, M J; Kleiboer, A M; van Silfhout, H G; Vink, G; Passchier, J

    2015-06-01

    This randomized, controlled trial examined the medium-term effectiveness of online behavioral training in migraine self-management (oBT; N = 195) versus waitlist control (WLC; N = 173) on attack frequency, indicators of self-management (primary outcomes), headache top intensity, use of rescue medications, quality of life and disability (secondary outcomes). An online headache diary following the ICHD-II and questionnaires were completed at baseline (T0), post-training (T1) and six months later (T2). Missing data (T1: 24%; T2: 37%) were handled by multiple imputation. We established effect sizes (ES) and tested between-group differences over time with linear mixed modelling techniques based on the intention-to-treat principle. At T2, attack frequency had improved significantly in oBT (-23%, ES = 0.66) but also in WLC (-19%; ES = 0.52). Self-efficacy, internal and external control in migraine management--and triptan use--improved only in oBT, however. This indicates different processes in both groups and could signify (the start of) active self-management in oBT. Also, only oBT improved migraine-specific quality of life to a sizable extent. oBT produced self-management gains but could not account for improved attack frequency, because WLC improved as well. The perspective that BT effects develop gradually, and that online delivery will boost BT outreach, justifies further research. © International Headache Society 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

  2. Long-Term Outcomes From a Prospective Trial of Stereotactic Body Radiotherapy for Low-Risk Prostate Cancer

    International Nuclear Information System (INIS)

    King, Christopher R.; Brooks, James D.; Gill, Harcharan; Presti, Joseph C.

    2012-01-01

    Purpose: Hypofractionated radiotherapy has an intrinsically different normal tissue and tumor radiobiology. The results of a prospective trial of stereotactic body radiotherapy (SBRT) for prostate cancer with long-term patient-reported toxicity and tumor control rates are presented. Methods and Materials: From 2003 through 2009, 67 patients with clinically localized low-risk prostate cancer were enrolled. Treatment consisted of 36.25 Gy in 5 fractions using SBRT with the CyberKnife as the delivery technology. No patient received hormone therapy. Patient self-reported bladder and rectal toxicities were graded on the Radiation Therapy Oncology Group scale (RTOG). Results: Median follow-up was 2.7 years. There were no grade 4 toxicities. Radiation Therapy Oncology Group Grade 3, 2, and 1 bladder toxicities were seen in 3% (2 patients), 5% (3 patients), and 23% (13 patients) respectively. Dysuria exacerbated by urologic instrumentation accounted for both patients with Grade 3 toxicity. Urinary incontinence, complete obstruction, or persistent hematuria was not observed. Rectal Grade 3, 2, and 1 toxicities were seen in 0, 2% (1 patient), and 12.5% (7 patients), respectively. Persistent rectal bleeding was not observed. Low-grade toxicities were substantially less frequent with QOD vs. QD dose regimen (p = 0.001 for gastrointestinal and p = 0.007 for genitourinary). There were two prostate-specific antigen (PSA), biopsy-proven failures with negative metastatic workup. Median PSA at follow-up was 0.5 ± 0.72 ng/mL. The 4-year Kaplan-Meier PSA relapse-free survival was 94% (95% confidence interval, 85%–102%). Conclusion: Significant late bladder and rectal toxicities from SBRT for prostate cancer are infrequent. PSA relapse-free survival compares favorably with other definitive treatments. The current evidence supports consideration of stereotactic body radiotherapy among the therapeutic options for localized prostate cancer.

  3. Long-Term Outcomes From a Prospective Trial of Stereotactic Body Radiotherapy for Low-Risk Prostate Cancer

    Energy Technology Data Exchange (ETDEWEB)

    King, Christopher R., E-mail: crking@mednet.ucla.edu [Departments of Radiation Oncology and Urology, University of California Los Angeles School of Medicine, Los Angeles, CA (United States); Brooks, James D.; Gill, Harcharan; Presti, Joseph C. [Department of Urology, Stanford University School of Medicine, Stanford, CA (United States)

    2012-02-01

    Purpose: Hypofractionated radiotherapy has an intrinsically different normal tissue and tumor radiobiology. The results of a prospective trial of stereotactic body radiotherapy (SBRT) for prostate cancer with long-term patient-reported toxicity and tumor control rates are presented. Methods and Materials: From 2003 through 2009, 67 patients with clinically localized low-risk prostate cancer were enrolled. Treatment consisted of 36.25 Gy in 5 fractions using SBRT with the CyberKnife as the delivery technology. No patient received hormone therapy. Patient self-reported bladder and rectal toxicities were graded on the Radiation Therapy Oncology Group scale (RTOG). Results: Median follow-up was 2.7 years. There were no grade 4 toxicities. Radiation Therapy Oncology Group Grade 3, 2, and 1 bladder toxicities were seen in 3% (2 patients), 5% (3 patients), and 23% (13 patients) respectively. Dysuria exacerbated by urologic instrumentation accounted for both patients with Grade 3 toxicity. Urinary incontinence, complete obstruction, or persistent hematuria was not observed. Rectal Grade 3, 2, and 1 toxicities were seen in 0, 2% (1 patient), and 12.5% (7 patients), respectively. Persistent rectal bleeding was not observed. Low-grade toxicities were substantially less frequent with QOD vs. QD dose regimen (p = 0.001 for gastrointestinal and p = 0.007 for genitourinary). There were two prostate-specific antigen (PSA), biopsy-proven failures with negative metastatic workup. Median PSA at follow-up was 0.5 {+-} 0.72 ng/mL. The 4-year Kaplan-Meier PSA relapse-free survival was 94% (95% confidence interval, 85%-102%). Conclusion: Significant late bladder and rectal toxicities from SBRT for prostate cancer are infrequent. PSA relapse-free survival compares favorably with other definitive treatments. The current evidence supports consideration of stereotactic body radiotherapy among the therapeutic options for localized prostate cancer.

  4. A multicomponent exercise program improves physical function in long-term nursing home residents: A randomized controlled trial.

    Science.gov (United States)

    Arrieta, Haritz; Rezola-Pardo, Chloe; Zarrazquin, Idoia; Echeverria, Iñaki; Yanguas, Jose Javier; Iturburu, Miren; Gil, Susana Maria; Rodriguez-Larrad, Ana; Irazusta, Jon

    2018-03-01

    To investigate the impact of a multicomponent exercise program on anthropometry, physical function, and physical activity on older adults living in long-term nursing homes (LTNH), we conducted a randomized controlled trial involving 112 participants aged 84.9 ± 6.9 years. Participants were randomly assigned to an intervention (IG) or control group (CG). The IG participated in a 3-month multicomponent exercise intervention focused on strength, balance, stretching exercises, and walking recommendations. Subjects in the CG participated in routine activities. Analyses of outcome parameters were performed in the entire sample and in two subgroups, classified according to participants' physical function score at baseline. The group-by-time interaction, favoring the IG, was significant for the entire sample and for the participants in the low physical function subgroup for the following parameters: waist circumference, 30-s chair-stand, arm-curl, 8-ft timed up-and-go, SPPB score, gait speed, and Berg scale (p < .05). In participants with higher physical function at baseline, significant group-by-time interaction was observed in the SPPB score and Berg scale (p < .05). When differences were analyzed within groups, the IG maintained or improved in all assessed parameters, while participants in the CG showed a marked decline. Our study showed that a multicomponent exercise program is effective for older people living in LTNH. This is especially relevant in those with lower physical function scores. The lower efficacy of the program in participants with better function might be due to the insufficient exercise demands of our intervention for more fit residents. Future studies should analyze the effects of programs with higher intensities in older people with intermediate to high physical function. Copyright © 2018 Elsevier Inc. All rights reserved.

  5. [Alcohol versus bath and natural drying for term newborns' umbilical cord care: a prospective randomized clinical trial].

    Science.gov (United States)

    Covas, María del Carmen; Alda, Ernesto; Medina, María Sol; Ventura, Silvia; Pezutti, Ornella; Paris de Baeza, Ana; Sillero, Josefna; Esandi, María Eugenia

    2011-08-01

    Umbilical cord (UC) care is a cause of concern for parents right from birth until its separation. Standard practice in Argentina includes frequent cleansing of the UC with alcohol and body bath only two days after its separation. The effect of different methods of UC care on its separation time and on colonization with microorganisms has been insufficiently explored. Main: To compare the effect on time of UC separation when using body bath with neutral soap followed by natural drying of the UC vs. standard care. Secondary: a) colonization rates during hospitalization; b) incidence of skin infection and conjunctivitis and c) parental comfort with both types of care. Normal term newborns (≥37 weeks), born at the HPS, and whose parents provided informed consent. Open prospective controlled clinical trial, with random allocation to two groups: study group -natural drying of the UC and body bath with neutral soap- and control group -UC hygiene with alcohol 70% at each diaper change until its separation and bath two days later-. UC separation time; UC colonization during hospital stay and skin and conjunctive infections in the first 30 days of life were monitored. Analysis was by intention-to-treat. 362 newborns were included, 181 in each group. The groups were well balanced in baseline characteristics. Being in the study group was associated with a shorter time to UC separation (median [interquartile range]= 6.00 [3] vs. 7.00 [4] days; p natural drying of the UC reduced the time to cord separation. This practice increased the colonization rate, but the risk of skin and conjunctive infections was apparently not modified by it. However, the study has insufficient power for secondary outcomes. Health care providers should continue to develop evidence to support or eliminate historical practices.

  6. Study protocol for the Flooring for Injury Prevention (FLIP) Study: a randomised controlled trial in long-term care.

    Science.gov (United States)

    Lachance, Chantelle C; Feldman, Fabio; Laing, Andrew C; Leung, Pet Ming; Robinovitch, Stephen N; Mackey, Dawn C

    2016-12-01

    A promising strategy for reducing the incidence and severity of fall-related injuries in long-term care (LTC) is to decrease the ground surface stiffness, and the subsequent forces applied to the body parts at impact, through installation of compliant flooring that does not substantially affect balance or mobility. Definitive evidence of the effects of compliant flooring on fall-related injuries in LTC is lacking. The Flooring for Injury Prevention (FLIP) Study is designed to address this gap. The FLIP Study is a 4-year, parallel-group, 2-arm, randomised controlled superiority trial of flooring in 150 resident rooms at a LTC site. The primary objective is to determine whether compliant flooring reduces serious fall-related injuries relative to control flooring. Intervention (2.54 cm SmartCells compliant; 74 rooms) and control (2.54 cm plywood; 76 rooms) floorings were installed over the top of existing concrete floors and covered with identical 2.00 mm vinyl. The primary outcome is serious fall-related injury, defined as any impact-related injury due to a fall in a study room that results in Emergency Department visit or hospital admission. Secondary outcomes include minor fall-related injury, any fall-related injury, falls, number of fallers, fractures, and healthcare utilisation and costs for serious fall-related injuries. Randomisation of study rooms, and residents in rooms, was stratified by residential unit, and flooring assignments were concealed. Outcome ascertainment began September 2013. Results from the FLIP Study will provide evidence about the effects of compliant flooring on fall-related injuries in LTC and will guide development of safer environments for vulnerable older adults. NCT01618786. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  7. Effect of short-term estrogen therapy on endothelial function: a double-blinded, randomized, controlled trial.

    Science.gov (United States)

    Hurtado, R; Celani, M; Geber, S

    2016-10-01

    To evaluate the effect of short-term hormone replacement therapy with 0.625 mg conjugated estrogens daily on endothelial function of healthy postmenopausal women, using flow-mediated dilation (FMD) of the brachial artery. We performed a double-blinded, randomized, controlled trial over 3 years. Randomization was performed using computer-generated sorting. All participants were blinded to the use of conjugated equine estrogens (CEE) or placebo and FMD was assessed by a blinded examiner, before and after 28 days of medication. A total of 64 healthy postmenopausal women were selected and randomly assigned into two groups of treatment: 0.625 mg of CEE or placebo. FMD values were statistically different between the groups (p = 0.025): the group receiving CEE showed a FMD value of 0.011 compared to the placebo group (FMD = -0.082). The two groups were additionally evaluated for homogeneity through the Shapiro-Wilk test in respect to variables that could interfere with endothelial function such as age (p = 0.729), body mass index (p = 0.891), and time since menopause (p = 0.724). Other variables were excluded during selection of the participants such as chronic vascular conditions, smoking, and sedentary lifestyle. Our results demonstrate that the administration of 0.625 mg CEE for 28 days is effective in improving vascular nitric oxide-dependent dilation assessed by FMD of the brachial artery in postmenopausal women. NCT01482416.

  8. Effect of Talbinah food consumption on depressive symptoms among elderly individuals in long term care facilities, randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Badrasawi MM

    2013-03-01

    Full Text Available Manal M Badrasawi, Suzana Shahar, Zahara Abd Manaf, Hasnah HaronDietetics program, School of Health Care Sciences, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Kuala Lumpur, MalaysiaAbstract: Talbinah is a barley syrup cooked with milk and sweetened by honey. In his famous Hadith on Talbinah, the Prophet Mohammad (SAW recommended it when sad events happen for its effect on soothing hearts and relieving sadness. This 3-week crossover designed, randomized clinical trial was conducted to determine the effect of Talbinah on mood and depression among institutionalized elderly people in Seremban. A sample of 30 depressed elderly subjects (21 men and 9 women was selected from the long term care facility. Three different interview-based validated scales (Geriatric Depression Scale, Depression Anxiety Stress Scales, and Profile of Mood States were used to determine mood, depression, stress, and anxiety at week 0, 3, 4, and 7. The nutritional value of Talbinah was examined using proximate food analysis, minerals content analysis, and differential amino acid analysis. The results indicated that Talbinah is a high carbohydrate food (86.4% and has a high tryptophan: branch chain amino acids ratio (1:2. A Wilcoxon nonparametric test showed that there was a statistically significant decrease on depression, stress, and mood disturbances scores among the intervention group (P < 0.05 for all parameters. In conclusion, Talbinah has the potential to reduce depression and enhance mood among the subjects. Ingestion of functional foods such as Talbinah may provide a mental health benefit to elderly people.Keywords: Talbinah, food and depression, cross over study, elderly

  9. A pilot randomized crossover trial assessing the safety and short-term effects of pomegranate supplementation in hemodialysis patients.

    Science.gov (United States)

    Rivara, Matthew B; Mehrotra, Rajnish; Linke, Lori; Ruzinski, John; Ikizler, T Alp; Himmelfarb, Jonathan

    2015-01-01

    Oxidative stress and systemic inflammation are highly prevalent in patients undergoing maintenance hemodialysis (MHD) and are linked to excess cardiovascular risk. This study examined whether short-term supplementation with pomegranate juice and extract is safe and well tolerated by MHD patients. The secondary aim was to assess the effect of pomegranate supplementation on oxidative stress, systemic inflammation, monocyte function, and blood pressure. Prospective, randomized, crossover, pilot clinical trial (NCT01562340). The study was conducted from March to October 2012 in outpatient dialysis facilities in the Seattle metropolitan area. Twenty-four patients undergoing MHD (men, 64%; mean age, 61 ± 14 years) were randomly assigned to receive pomegranate juice or extract during a 4-week intervention period. After a washout period, all patients received the alternative treatment during a second 4-week intervention period. Patients assigned to receive pomegranate juice received 100 mL of juice before each dialysis session. Patients assigned to receive pomegranate extract were given 1,050 mg of extract daily. The main outcome measures were safety and tolerability of pomegranate juice and extract. Additional secondary outcomes assessed included serum lipids, laboratory biomarkers of inflammation (C-reactive protein and interleukin 6) and oxidative stress (plasma F2 isoprostanes and isofurans), monocyte cytokine production, and predialysis blood pressure. Both pomegranate juice and extract were safe and well tolerated by study participants. Over the study period, neither treatment had a significant effect on lipid profiles, plasma C-reactive protein, interleukin 6, F2-isoprostane or isofuran concentrations, predialysis systolic or diastolic blood pressure nor changed the levels of monocyte cytokine production. Both pomegranate juice and extract are safe and well tolerated by patients undergoing MHD but do not influence markers of inflammation or oxidative stress

  10. Short-term effects of customized arch support insoles on symptomatic flexible flatfoot in children: A randomized controlled trial.

    Science.gov (United States)

    Hsieh, Ru-Lan; Peng, Hui-Ling; Lee, Wen-Chung

    2018-05-01

    Limited evidence is available regarding the effects of insoles on pediatric flexible flatfoot because of the heterogeneity and low methodological quality of previous studies. The purpose of this prospective trial is to examine the short-term effects of customized arch support insoles on symptomatic flexible flatfoot in children by using the International Classification of Functioning, randomized controlled Disability, and Health (ICF) framework. This study was conducted in a rehabilitation outpatient clinic of a teaching hospital. Fifty-two children with symptomatic flexible flatfoot were included. The children in the treatment group wore customized arch support insoles for 12 weeks, whereas those in the control group did not wear the insoles. Both clinical and radiographic measurements, including the navicular drop, foot posture index, Beighton hypermobility score, talonavicular coverage angle, calcaneal inclination angle, and calcaneal-first metatarsal angle, were used for diagnosing flexible flatfoot. Physical activity (10-m normal and fast walking, stair ascent, stair descent, and chair rising), physical function, and psychometric properties (Pediatric Outcome Data Collection Instrument and Pediatric Quality of Life Inventory) were evaluated at the baseline and 12 weeks after the intervention. Compared with the control group, the treatment group exhibited significant improvement in pain/comfort (P = .048), physical health (P = .035), stair ascent time (P = .015), upper extremity and physical function (P = .016), and transfer and basic mobility (P = .042) during the intervention period. Children with flexible flatfoot who wore customized arch support insoles for 12 weeks exhibited significantly improved pain/comfort, physical health, stair ascent time, upper extremity and physical function, and transfer and basic mobility. These variables belong to the domains of body functions and structures and activity and participation in the ICF

  11. Phase II trial of short-term neoadjuvant docetaxel and complete androgen blockade in high-risk prostate cancer

    Science.gov (United States)

    Mellado, B; Font, A; Alcaraz, A; Aparicio, L A; Veiga, F J G; Areal, J; Gallardo, E; Hannaoui, N; Lorenzo, J R M; Sousa, A; Fernandez, P L; Gascon, P

    2009-01-01

    Background: The low probability of curing high-risk prostate cancer (PC) with local therapy suggests the need to study modality of therapeutic approaches. To this end, a prospective phase II trial of neoadjuvant docetaxel (D) and complete androgen blockade (CAB) was carried out in high-risk PC patients. The primary end point was to detect at least 10% of pCRs after chemohormonal treatment. Methods: Patients with T1c–T2 clinical stage with prostate-specific antigen (PSA) >20 ng ml−1 and/or Gleason score ⩾7 (4+3) and T3 were included. Treatment consisted of three cycles of D 36 mg m−2 on days 1, 8 and 15 every 28 days concomitant with CAB, followed by radical prostatectomy (RP). Results: A total of 57 patients were included. Clinical stage was T1c, 11 patients (19.3%); T2, 30 (52.6%) and T3, 16 (28%) patients. Gleason score was ⩾7 (4+3) in 44 (77%) patients and PSA >20 ng ml−1 in 15 (26%) patients. Treatment was well tolerated with 51 (89.9%) patients completing neoadjuvant therapy together with RP. The rate of pCR was 6% (three patients). Three (6%) additional patients had microscopic residual tumour (near pCR) in prostate specimen. With a median follow-up of 35 months, 18 (31.6%) patients presented PSA relapse. Conclusion: Short-term neoadjuvant D and CAB induced a 6% pCR rate, which is close to what would be expected with ADT alone. The combination was generally well tolerated. PMID:19755998

  12. 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.

  13. Moxibustion for cephalic version: a feasibility randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Bisits Andrew

    2011-09-01

    Full Text Available Abstract Background Moxibustion (a type of Chinese medicine which involves burning a herb close to the skin has been used to correct a breech presentation. Evidence of effectiveness and safety from systematic reviews is encouraging although significant heterogeneity has been found among trials. We assessed the feasibility of conducting a randomised controlled trial of moxibustion plus usual care compared with usual care to promote cephalic version in women with a breech presentation, and examined the views of women and health care providers towards implementing a trial within an Australian context. Methods The study was undertaken at a public hospital in Newcastle, New South Wales, Australia. Women at 34-36.5 weeks of gestation with a singleton breech presentation (confirmed by ultrasound, were randomised to moxibustion plus usual care or usual care alone. The intervention was administered over 10 days. Clinical outcomes included cephalic presentation at birth, the need for ECV, mode of birth; perinatal morbidity and mortality, and maternal complications. Feasibility outcomes included: recruitment rate, acceptability, compliance and a sample size for a future study. Interviews were conducted with 19 midwives and obstetricians to examine the acceptability of moxibustion, and views on the trial. Results Twenty women were randomised to the trial. Fifty one percent of women approached accepted randomisation to the trial. A trend towards an increase in cephalic version at delivery (RR 5.0; 95% CI 0.7-35.5 was found for women receiving moxibustion compared with usual care. There was also a trend towards greater success with version following ECV. Two babies were admitted to the neonatal unit from the moxibustion group. Compliance with the moxibustion protocol was acceptable with no reported side effects. Clinicians expressed the need for research to establish the safety and efficacy of moxibustion, and support for the intervention was given to

  14. Short Term Analgesic Effects of 5% Dextrose Epidural Injections for Chronic Low Back Pain: A Randomized Controlled Trial.

    Science.gov (United States)

    Maniquis-Smigel, Liza; Dean Reeves, Kenneth; Jeffrey Rosen, Howard; Lyftogt, John; Graham-Coleman, Cassie; Cheng, An-Lin; Rabago, David

    2017-02-01

    Hypertonic dextrose injection (prolotherapy) is reported to reduce pain including non-surgical chronic low back pain (CLBP), and subcutaneous injection of 5% dextrose is reported to reduce neurogenic pain, hyperalgesia and allodynia. The mechanism in both cases is unclear, though a direct effect of dextrose on neurogenic pain has been proposed. This study assessed the short-term analgesic effects of epidural 5% dextrose injection compared with saline for non-surgical CLBP. Randomized double-blind (injector, participant) controlled trial. Adults with moderate-to-severe non-surgical low back pain with radiation to gluteal or leg areas for at least 6 months received a single epidurogram-confirmed epidural injection of 10 mL of 5% dextrose or 0.9% saline using a published vertical caudal injection technique. The primary outcome was change in a numerical rating scale (NRS, 0 - 10 points) pain score between baseline and 15 minutes; and 2, 4, and 48 hours and 2 weeks post-injection. The secondary outcome was percentage of participants achieving 50% or more pain improvement at 4 hours. No baseline differences existed between groups; 35 participants (54 ± 10.7 years old; 11 female) with moderate-to-severe CLBP (6.7 ± 1.3 points) for 10.6 ± 10.5 years. Dextrose participants reported greater NRS pain score change at 15 minutes (4.4 ± 1.7 vs 2.4 ± 2.8 points; P = 0.015), 2 hours (4.6 ± 1.9 vs 1.8 ± 2.8 points; P = 0.001), 4 hours (4.6 ± 2.0 vs 1.4 ± 2.3 points; P dextrose recipients and 19% (3/16) of saline recipients reported ≥ 50% pain reduction at 4 hours (P dextrose on pain at the dorsal root level; waning pain control at 2 weeks suggests the need to assess the effect of serial dextrose epidural injections in a long-term study with robust outcome assessment.

  15. Extended vs short-term buprenorphine-naloxone for treatment of opioid-addicted youth: a randomized trial.

    Science.gov (United States)

    Woody, George E; Poole, Sabrina A; Subramaniam, Geetha; Dugosh, Karen; Bogenschutz, Michael; Abbott, Patrick; Patkar, Ashwin; Publicker, Mark; McCain, Karen; Potter, Jennifer Sharpe; Forman, Robert; Vetter, Victoria; McNicholas, Laura; Blaine, Jack; Lynch, Kevin G; Fudala, Paul

    2008-11-05

    The usual treatment for opioid-addicted youth is detoxification and counseling. Extended medication-assisted therapy may be more helpful. To evaluate the efficacy of continuing buprenorphine-naloxone for 12 weeks vs detoxification for opioid-addicted youth. Clinical trial at 6 community programs from July 2003 to December 2006 including 152 patients aged 15 to 21 years who were randomized to 12 weeks of buprenorphine-naloxone or a 14-day taper (detox). Patients in the 12-week buprenorphine-naloxone group were prescribed up to 24 mg per day for 9 weeks and then tapered to week 12; patients in the detox group were prescribed up to 14 mg per day and then tapered to day 14. All were offered weekly individual and group counseling. Opioid-positive urine test result at weeks 4, 8, and 12. The number of patients younger than 18 years was too small to analyze separately, but overall, patients in the detox group had higher proportions of opioid-positive urine test results at weeks 4 and 8 but not at week 12 (chi(2)(2) = 4.93, P = .09). At week 4, 59 detox patients had positive results (61%; 95% confidence interval [CI] = 47%-75%) vs 58 12-week buprenorphine-naloxone patients (26%; 95% CI = 14%-38%). At week 8, 53 detox patients had positive results (54%; 95% CI = 38%-70%) vs 52 12-week buprenorphine-naloxone patients (23%; 95% CI = 11%-35%). At week 12, 53 detox patients had positive results (51%; 95% CI = 35%-67%) vs 49 12-week buprenorphine-naloxone patients (43%; 95% CI = 29%-57%). By week 12, 16 of 78 detox patients (20.5%) remained in treatment vs 52 of 74 12-week buprenorphine-naloxone patients (70%; chi(2)(1) = 32.90, P < .001). During weeks 1 through 12, patients in the 12-week buprenorphine-naloxone group reported less opioid use (chi(2)(1) = 18.45, P < .001), less injecting (chi(2)(1) = 6.00, P = .01), and less nonstudy addiction treatment (chi(2)(1) = 25.82, P < .001). High levels of opioid use occurred in both groups at follow-up. Four of 83 patients who tested

  16. Snoezelen, structured reminiscence therapy and 10-minutes activation in long term care residents with dementia (WISDE: study protocol of a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Becker Christiane

    2010-01-01

    Full Text Available Abstract Background People with dementia are often inapproachable due to symptoms of their illness. Therefore nurses should establish relationships with dementia patients via their remaining resources and facilitate communication. In order to achieve this, different targeted non-pharmacological interventions are recommended and practiced. However there is no sufficient evidence about the efficacy of most of these interventions. A number of publications highlight the urgent need for methodological sound studies so that more robust conclusions may be drawn. Methods/Design The trial is designed as a cluster randomized controlled trial with 20 nursing homes in Saxony and Saxony-Anhalt (Germany as the units of randomization. Nursing homes will be randomly allocated into 4 study groups consisting of 5 clusters and 90 residents: snoezelen, structured reminiscence therapy, 10-minutes activation or unstructured verbal communication (control group. The purpose is to determine whether the interventions are effective to reduce apathy in long-term care residents with dementia (N = 360 as the main outcome measure. Assessments will be done at baseline, 3, 6 and 12 months after beginning of the interventions. Discussion This trial will particularly contribute to the evidence on efficacy of non-pharmacological interventions in dementia care. Trial Registration ClinicalTrials.gov NCT00653731

  17. Health-related quality of life of young adults with Turner syndrome following a long-term randomized controlled trial of recombinant human growth hormone

    Directory of Open Access Journals (Sweden)

    Van Vliet Guy

    2011-05-01

    Full Text Available Abstract Background There are limited long-term randomized controlled trials of growth hormone (GH supplementation to adult height and few published reports of the health-related quality of life (HRQOL following treatment. The present follow-up study of young adults from a long-term controlled trial of GH treatment in patients with Turner syndrome (TS yielded data to examine whether GH supplementation resulted in a higher HRQOL (either due to taller stature or from the knowledge that active treatment and not placebo had been received or alternatively a lower HRQOL (due to medicalization from years of injections. Methods The original trial randomized 154 Canadian girls with TS aged 7-13 years from 13 centres to receive either long-term GH injections at the pharmacologic dose of 0.3 mg/kg/week or to receive no injections; estrogen prescription for induction of puberty was standardized. Patients were eligible for the follow-up study if they were at least 16 years old at the time of follow-up. The instrument used to study HRQOL was the SF-36, summarized into physical and mental component scales (PCS and MCS; higher scores indicate better HRQOL. Results Thirty-four of the 48 eligible participants (71% consented to participate; data were missing for one patient. Both groups (GH and no treatment had normal HRQOL at this post-treatment assessment. The GH group had a (mean ± SD PCS score of 56 ± 5; the untreated group 58 ± 4; mean score for 16-24 year old females in the general population 53.5 ± 6.9. The GH group had a mean MCS score of 52 ± 6; the untreated group 49 ± 13; mean score for 16-24 year old females in the general population 49.6 ± 9.8. Secondary analyses showed no relationship between HRQOL and height. Conclusions We found no benefit or adverse effect on HRQOL either from receiving or not receiving growth hormone injections in a long-term randomized controlled trial, confirming larger observational studies. We suggest that it remains

  18. Circumferential fusion is dominant over posterolateral fusion in a long-term perspective: cost-utility evaluation of a randomized controlled trial in severe, chronic low back pain

    DEFF Research Database (Denmark)

    Soegaard, Rikke; Bünger, Cody E; Christiansen, Terkel

    2007-01-01

    STUDY DESIGN: Cost-utility evaluation of a randomized, controlled trial with a 4- to 8-year follow-up. OBJECTIVE: To investigate the incremental cost per quality-adjusted-life-year (QALY) when comparing circumferential fusion to posterolateral fusion in a long-term, societal perspective. SUMMARY...... OF BACKGROUND DATA: The cost-effectiveness of circumferential fusion in a long-term perspective is uncertain but nonetheless highly relevant as the ISSLS prize winner 2006 in clinical studies reported the effect of circumferential fusion superior to the effect of posterolateral fusion. A recent trial found...... no significant difference between posterolateral and circumferential fusion reporting cost-effectiveness from a 2-year viewpoint. METHODS: A total of 146 patients were randomized to posterolateral or circumferential fusion and followed 4 to 8 years after surgery. The mean age of the cohort was 46 years (range...

  19. Short-term and long-term effects of dipeptidyl peptidase-4 inhibitors in type 2 diabetes mellitus patients with renal impairment: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Li, Ruifei; Wang, Rui; Li, Haixia; Sun, Sihao; Zou, Meijuan; Cheng, Gang

    2016-09-01

    To assess the short-term and long-term effects of dipeptidyl peptidase-4 (DPP-4) inhibitors in type 2 diabetes mellitus patients with renal impairment, a meta-analysis of randomized clinical trials of DPP-4 inhibitor interventions in type 2 diabetes mellitus patients with renal impairment was performed. PubMed, Embase, Cochrane Library and ClinicalTrials.gov were searched through the end of March 2015. Randomized clinical trials were selected if (1) DPP-4 inhibitors were compared with a placebo or other active-comparators, (2) the treatment duration was ≥12 weeks and (3) data regarding changes in haemoglobin A1c (HbA1c ), changes in fasting plasma glucose or hypoglycaemia and other adverse events were reported. Of 790 studies, ten studies on eight randomized clinical trials were included. Compared with the control group, DPP-4 inhibitors were associated with a greater HbA1c reduction in both the short-term [mean differences (MD) = -0.45, 95% confidence intervals (-0.57, -0.33), p 1] and long-term [MD = -0.33, 95% confidence intervals (-0.63, -0.03), p = 0.03] treatments. However, the long-term greater reduction in HbA1c with DPP-4 inhibitor treatment was only significant when the control treatment comprised placebo plus stable background treatment, but not glipizide plus stable background treatment. DPP-4 inhibitors were associated with a greater fasting plasma glucose reduction [MD = -12.59, 95% confidence intervals (-22.01, -3.17), p = 0.009] over the short-term; however, this effect was not present over the long-term. Regarding the hypoglycaemia adverse events assessment, the long-term treatment data indicated there was no increased risk of hypoglycaemia compared with placebo or active-controlled anti-diabetic drugs. The present meta-analysis confirms that DPP-4 inhibitors are effective and equivalent to other agents in type 2 diabetes mellitus patients with renal impairment. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015

  20. Reducing the cesarean delivery rates for breech presentations: administration of spinal anesthesia facilitates manipulation to cephalic presentation, but is it cost saving?

    Science.gov (United States)

    2014-01-01

    Background External cephalic version (ECV) is infrequently performed and 98% of breech presenting fetuses are delivered surgically. Neuraxial analgesia can increase the success rate of ECV significantly, potentially reducing cesarean delivery rates for breech presentation. The current study aims to determine whether the additional cost to the hospital of spinal anesthesia for ECV is offset by cost savings generated by reduced cesarean delivery. Methods In our tertiary hospital, three variables manpower, disposables, and fixed costs were calculated for ECV, ECV plus anesthetic doses of spinal block, vaginal delivery and cesarean delivery. Total procedure costs were compared for possible delivery pathways. Manpower data were obtained from management payroll, fixed costs by calculating cost/lifetime usage rate and disposables were micro-costed in 2008, expressed in 2013 NIS. Results Cesarean delivery is the most expensive option, 11670.54 NIS and vaginal delivery following successful ECV under spinal block costs 5497.2 NIS. ECV alone costs 960.21 NIS, ECV plus spinal anesthesia costs 1386.97 NIS. The highest individual cost items for vaginal, cesarean delivery and ECV were for manpower. Expensive fixed costs for cesarean delivery included operating room trays and postnatal hospitalization (minimum 3 days). ECV with spinal block is cheaper due to lower expected cesarean delivery rate and its lower associated costs. Conclusions The additional cost of the spinal anesthesia is offset by increased success rates for the ECV procedure resulting in reduction in the cesarean delivery rate. PMID:24564984

  1. Randomized controlled trial evaluating the temporal effects of high-intensity exercise on learning, short-term and long-term memory, and prospective memory.

    Science.gov (United States)

    Frith, Emily; Sng, Eveleen; Loprinzi, Paul D

    2017-11-01

    The broader purpose of this study was to examine the temporal effects of high-intensity exercise on learning, short-term and long-term retrospective memory and prospective memory. Among a sample of 88 young adult participants, 22 were randomized into one of four different groups: exercise before learning, control group, exercise during learning, and exercise after learning. The retrospective assessments (learning, short-term and long-term memory) were assessed using the Rey Auditory Verbal Learning Test. Long-term memory including a 20-min and 24-hr follow-up assessment. Prospective memory was assessed using a time-based procedure by having participants contact (via phone) the researchers at a follow-up time period. The exercise stimulus included a 15-min bout of progressive maximal exertion treadmill exercise. High-intensity exercise prior to memory encoding (vs. exercise during memory encoding or consolidation) was effective in enhancing long-term memory (for both 20-min and 24-h follow-up assessments). We did not observe a differential temporal effect of high-intensity exercise on short-term memory (immediate post-memory encoding), learning or prospective memory. The timing of high-intensity exercise may play an important role in facilitating long-term memory. © 2017 Federation of European Neuroscience Societies and John Wiley & Sons Ltd.

  2. Feasibility of personalised remote long-term follow-up of people with cochlear implants: a randomised controlled trial.

    Science.gov (United States)

    Cullington, Helen; Kitterick, Padraig; Weal, Mark; Margol-Gromada, Magdalena

    2018-04-20

    Substantial resources are required to provide lifelong postoperative care to people with cochlear implants. Most patients visit the clinic annually. We introduced a person-centred remote follow-up pathway, giving patients telemedicine tools to use at home so they would only visit the centre when intervention was required. To assess the feasibility of comparing a remote care pathway with the standard pathway in adults using cochlear implants. Two-arm randomised controlled trial. Randomisation used a minimisation approach, controlling for potential confounding factors. Participant blinding was not possible, but baseline measures occurred before allocation. University of Southampton Auditory Implant Service: provider of National Health Service care. 60 adults who had used cochlear implants for at least 6 months. Control group (n=30) followed usual care pathway.Remote care group (n=30) received care remotely for 6 months incorporating: home hearing in noise test, online support tool and self-adjustment of device (only 10 had compatible equipment). Primary: change in patient activation; measured using the Patient Activation Measure.Secondary: change in hearing and quality of life; qualitative feedback from patients and clinicians. One participant in the remote care group dropped out. The remote care group showed a greater increase in patient activation than the control group. Changes in hearing differed between the groups. The remote care group improved on the Triple Digit Test hearing test; the control group perceived their hearing was worse on the Speech, Spatial and Qualities of Hearing Scale questionnaire. Quality of life remained unchanged in both groups. Patients and clinicians were generally positive about remote care tools and wanted to continue. Adults with cochlear implants were willing to be randomised and complied with the protocol. Personalised remote care for long-term follow-up is feasible and acceptable, leading to more empowered patients. ISRCTN14644286

  3. Ursodeoxycholic acid versus placebo, and early term delivery versus expectant management, in women with intrahepatic cholestasis of pregnancy: semifactorial randomised clinical trial.

    Science.gov (United States)

    Chappell, Lucy C; Gurung, Vinita; Seed, Paul T; Chambers, Jenny; Williamson, Catherine; Thornton, James G

    2012-06-13

    To test whether ursodeoxycholic acid reduces pruritus in women with intrahepatic cholestasis of pregnancy, whether early term delivery does not increase the incidence of caesarean section, and the feasibility of recruiting women with intrahepatic cholestasis of pregnancy to trials of these interventions. First phase of a semifactorial randomised controlled trial. Nine consultant led maternity units, United Kingdom. 125 women with intrahepatic cholestasis of pregnancy (pruritus and raised levels of serum bile acids) or pruritus and raised alanine transaminase levels (>100 IU/L) recruited after 24 weeks' gestation and followed until delivery. 56 women were randomised to ursodeoxycholic acid, 55 to placebo, 30 to early term delivery, and 32 to expectant management. Ursodeoxycholic acid 500 mg twice daily or placebo increased as necessary for symptomatic or biochemical improvement until delivery; early term delivery (induction or delivery started between 37+0 and 37+6) or expectant management (spontaneous labour awaited until 40 weeks' gestation or caesarean section undertaken by normal obstetric guidelines, usually after 39 weeks' gestation). The primary outcome for ursodeoxycholic acid was maternal itch (arithmetic mean of measures (100 mm visual analogue scale) of worst itch in past 24 hours) and for the timing of delivery was caesarean section. Secondary outcomes were other maternal and perinatal outcomes and recruitment rates. Ursodeoxycholic acid reduced itching by -16 mm (95% confidence interval -27 mm to -6 mm), less than the 30 mm difference prespecified by clinicians and women as clinically meaningful. 32% (14/44) of women randomised to ursodeoxycholic acid experienced a reduction in worst itching by at least 30 mm compared with 16% (6/37) randomised to placebo. The difference of 16% (95% confidence interval -3 to 34); this would represent a number needed to treat of 6, but it failed to reach significance. Early term delivery did not increase caesarean

  4. Prevention of colonic neoplasia with polyethylene glycol: A short term randomized placebo-controlled double-blinded trial.

    Science.gov (United States)

    Wali, Ramesh K; Bianchi, Laura; Kupfer, Sonia; De La Cruz, Mart; Jovanovic, Borko; Weber, Christopher; Goldberg, Michael J; Rodriguez, L M; Bergan, Raymond; Rubin, David; Tull, Mary Beth; Richmond, Ellen; Parker, Beth; Khan, Seema; Roy, Hemant K

    2018-01-01

    Chemoprevention represents an attractive modality against colorectal cancer (CRC) although widespread clinical implementation of promising agents (e.g. aspirin/NSAIDS) have been stymied by both suboptimal efficacy and concerns over toxicity. This highlights the need for better agents. Several groups, including our own, have reported that the over-the-counter laxative polyethylene glycol (PEG) has remarkable efficacy in rodent models of colon carcinogenesis. In this study, we undertook the first randomized human trial to address the role of PEG in prevention of human colonic neoplasia. This was a double-blind, placebo-controlled, three-arm trial where eligible subjects were randomized to 8g PEG-3350 (n = 27) or 17g PEG-3350 (n = 24), or placebo (n = 24; maltodextrin) orally for a duration of six months. Our initial primary endpoint was rectal aberrant crypt foci (ACF) but this was changed during protocol period to rectal mucosal epidermal growth factor receptor (EGFR). Of the 87 patients randomized, 48 completed study primary endpoints and rectal EGFR unchanged PEG treatment. Rectal ACF had a trend suggesting potentially reduction with PEG treatment (pre-post change 1.7 in placebo versus -0.3 in PEG 8+ 17g doses, p = 0.108). Other endpoints (proliferation, apoptosis, expression of SNAIL and E-cadherin), previously noted to be modulated in rodent models, appeared unchanged with PEG treatment in this clinical trial. We conclude that PEG was generally well tolerated with the trial failing to meet primary efficacy endpoints. However, rectal ACFs demonstrated a trend (albeit statistically insignificant) for suppression with PEG. Moreover, all molecular assays including EGFR were unaltered with PEG underscoring issues with lack of translatability of biomarkers from preclinical to clinical trials. This data may provide the impetus for future clinical trials on PEG using more robust biomarkers of chemoprevention. ClinicalTrials.gov NCT00828984.

  5. Early autologous stem cell transplantation for chronic lymphocytic leukemia: long-term follow-up of the German CLL Study Group CLL3 trial.

    Science.gov (United States)

    Dreger, Peter; Döhner, Hartmut; McClanahan, Fabienne; Busch, Raymonde; Ritgen, Matthias; Greinix, Hildegard; Fink, Anna-Maria; Knauf, Wolfgang; Stadler, Michael; Pfreundschuh, Michael; Dührsen, Ulrich; Brittinger, Günter; Hensel, Manfred; Schetelig, Johannes; Winkler, Dirk; Bühler, Andreas; Kneba, Michael; Schmitz, Norbert; Hallek, Michael; Stilgenbauer, Stephan

    2012-05-24

    The CLL3 trial was designed to study intensive treatment including autologous stem cell transplantation (autoSCT) as part of first-line therapy in patients with chronic lymphocytic leukemia (CLL). Here, we present the long-term outcome of the trial with particular focus on the impact of genomic risk factors, and we provide a retrospective comparison with patients from the fludarabine-cyclophosphamide-rituximab (FCR) arm of the German CLL Study Group (GCLLSG) CLL8 trial. After a median observation time of 8.7 years (0.3-12.3 years), median progression-free survival (PFS), time to retreatment, and overall survival (OS) of 169 evaluable patients, including 38 patients who did not proceed to autoSCT, was 5.7, 7.3, and 11.3 years, respectively. PFS and OS were significantly reduced in the presence of 17p- and of an unfavorable immunoglobulin heavy variable chain mutational status, but not of 11q-. Five-year nonrelapse mortality was 6.5%. When 110 CLL3 patients were compared with 126 matched patients from the FCR arm of the CLL8 trial, 4-year time to retreatment (75% vs 77%) and OS (86% vs 90%) was similar despite a significant benefit for autoSCT in terms of PFS. In summary, early treatment intensification including autoSCT can provide very effective disease control in poor-risk CLL, although its clinical benefit in the FCR era remains uncertain. The trial has been registered with www.clinicaltrials.gov as NCT00275015.

  6. Long-term safety evaluation of bimatoprost ophthalmic solution 0.03%: a pooled analysis of six double-masked, randomized, active-controlled clinical trials

    Directory of Open Access Journals (Sweden)

    Wirta D

    2011-06-01

    Full Text Available David Wirta1, Amanda M VanDenburgh2, Emily Weng3, Scott M Whitcup4, Sef Kurstjens5, Frederick C Beddingfield III4,61Private Practice, Newport Beach, CA, USA; 2Clinical Development, 3Biostatistics, 4Research and Development, 5Global Drug Development, Allergan, Inc, Irvine, CA, USA; 6Department of Medicine, Division of Dermatology, David Geffen School of Medicine, UCLA, Los Angeles, CA, USABackground: Bimatoprost ophthalmic solution 0.03% was approved in the US for reducing intraoccular pressure (IOP based on two double-masked, active-controlled clinical trials. Four additional long-term studies (≥ 12months were conducted; however, the aggregate safety profile of the six studies has not been reported.Methods: Adverse events (AEs were pooled from six double-masked, active-controlled, long-term clinical trials in which subjects received bimatoprost 0.03% once daily (QD or twice daily (BID as an eyedrop. AE terms were converted to MedDRA (V.11.0 Preferred Terms and analyzed.Results: In total, 1409 patients received more than one dose of bimatoprost 0.03% QD or BID. Most AEs were mild in severity and reported by 86.7% (QD and 94.8% (BID of subjects (≤ 12 months of treatment. AEs reported through month 12 (aggregate incidence of ≥ 5% were conjunctival hyperemia, increased eyelash growth, eye pruritus, periocular skin hyperpigmentation, eye irritation, dry eye, and hypertrichosis. AE onset was generally reported within four months of treatment. The cumulative incidence of common AEs in the QD treatment group at 24–48 months was similar to that measured at 12 months of treatment.Conclusion: Bimatoprost 0.03% has a favorable safety and tolerability profile as characterized by six long-term studies. Common AEs were due to the known pharmacological activity of bimatoprost and reversible with treatment cessation.Keywords: intraocular pressure, eyelids, pharmacology, clinical trial, medical treatment

  7. Patterns of Change in Interpersonal Problems During and After Short-term and Long-term Psychodynamic Group Therapy: A Randomized Clinical Trial.

    Science.gov (United States)

    Fjeldstad, Anette; Høglend, Per; Lorentzen, Steinar

    2017-05-01

    In this study, we compared the patterns of change in interpersonal problems between short-term and long-term psychodynamic group therapy. A total of 167 outpatients with mixed diagnoses were randomized to 20 or 80 weekly sessions of group therapy. Interpersonal problems were assessed with the Inventory of Interpersonal Problems at six time points during the 3-year study period. Using linear mixed models, change was linearly modelled in two steps. Earlier (within the first 6 months) and later (during the last 2.5 years) changes in five subscales were estimated. Contrary to what we expected, short-term therapy induced a significantly larger early change than long-term therapy on the cold subscale and there was a trend on the socially avoidant subscale, using a Bonferroni-adjusted alpha. There was no significant difference between short-term and long-term group therapy for improving problems in the areas cold, socially avoidant, nonassertive, exploitable, and overly nurturant over the 3 years.

  8. A Reappraisal of Women’s Health Initiative Estrogen-Alone Trial: Long-Term Outcomes in Women 50–59 Years of Age

    Directory of Open Access Journals (Sweden)

    Eric Roehm

    2015-01-01

    Full Text Available The Women’s Health Initiative (WHI Estrogen-Alone Trial randomized postmenopausal women, 50 to 79 years of age, with prior hysterectomy, to conjugated equine estrogens (CEE or placebo with a 5.9-year median duration of CEE use. In 2013, the WHI published outcomes for additional extended follow-up. Reported here for the first time is an analysis of the number needed to treat with CEE rather than placebo for younger women (50–59 years to prevent an adverse long-term outcome. For every 76 women randomized to CEE at 50–59 years, one less myocardial infarction occurred during the 13-year cumulative long-term follow-up. For every 37 women randomized to CEE at 50–59 years, one less woman experienced a global index endpoint (including coronary heart disease, invasive breast cancer, stroke, pulmonary embolism, colorectal cancer, hip fracture, and death during the 13-year follow-up. Younger women (50–59 years, compared to older women, had more favorable cumulative long-term outcomes for MI and global index. Though a subgroup analysis is not an adequate basis for making primary prevention guideline recommendations, the WHI Estrogen-Alone Trial outcomes strongly suggest that a similar course of estrogen initiated at 50–59 years in postmenopausal women with prior hysterectomy results in significant long-term health benefit.

  9. Hysteroscopic Endometrial Resection Versus Laparoscopic Supracervical Hysterectomy for Abnormal Uterine Bleeding: Long-term Follow-up of a Randomized Trial.

    Science.gov (United States)

    Zupi, Errico; Centini, Gabriele; Lazzeri, Lucia; Finco, Andrea; Exacoustos, Caterina; Afors, Karolina; Zullo, Fulvio; Petraglia, Felice

    2015-01-01

    To compare long-term efficacy of laparoscopic supracervical hysterectomy (LSH) and hysteroscopic endometrial ablation (HEA) in treating persistent abnormal uterine bleeding. Canadian Task Force II-2. University hospital. One hundred fifty-three women treated for abnormal uterine bleeding by LSH or HEA. Long-term follow-up assessment of reintervention rate and quality of life (QoL) using the Quality Metric's Health Survey Short Form 12. This study is the long-term follow-up of a randomized control trial conducted in 2003 comparing LSH and HEA in terms of reoperation rate and QoL. Starting from November 2010 all patients included in the first trial were invited to participate in this study and clinically evaluated through vaginal examination and transvaginal ultrasound. After a mean follow-up of 14.4 years, 29% of patients (20/71) treated with HEA underwent further surgery, whereas no patients after LSH had symptom recurrence. The reintervention rate was significantly higher in the HEA group (p abnormal uterine bleeding when compared with HEA. Copyright © 2015 AAGL. Published by Elsevier Inc. All rights reserved.

  10. Effects of a manualized short-term treatment of internet and computer game addiction (STICA: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Jäger Susanne

    2012-04-01

    Full Text Available Abstract Background In the last few years, excessive internet use and computer gaming have increased dramatically. Salience, mood modification, tolerance, withdrawal symptoms, conflict, and relapse have been defined as diagnostic criteria for internet addiction (IA and computer addiction (CA in the scientific community. Despite a growing number of individuals seeking help, there are no specific treatments of established efficacy. Methods/design This clinical trial aims to determine the effect of the disorder-specific manualized short-term treatment of IA/CA (STICA. The cognitive behavioural treatment combines individual and group interventions with a total duration of 4 months. Patients will be randomly assigned to STICA treatment or to a wait list control group. Reliable and valid measures of IA/CA and co-morbid mental symptoms (for example social anxiety, depression will be assessed prior to the beginning, in the middle, at the end, and 6 months after completion of treatment. Discussion A treatment of IA/CA will establish efficacy and is desperately needed. As this is the first trial to determine efficacy of a disorder specific treatment, a wait list control group will be implemented. Pros and cons of the design were discussed. Trial Registration ClinicalTrials (NCT01434589

  11. Effects of a manualized short-term treatment of internet and computer game addiction (STICA): study protocol for a randomized controlled trial

    Science.gov (United States)

    2012-01-01

    Background In the last few years, excessive internet use and computer gaming have increased dramatically. Salience, mood modification, tolerance, withdrawal symptoms, conflict, and relapse have been defined as diagnostic criteria for internet addiction (IA) and computer addiction (CA) in the scientific community. Despite a growing number of individuals seeking help, there are no specific treatments of established efficacy. Methods/design This clinical trial aims to determine the effect of the disorder-specific manualized short-term treatment of IA/CA (STICA). The cognitive behavioural treatment combines individual and group interventions with a total duration of 4 months. Patients will be randomly assigned to STICA treatment or to a wait list control group. Reliable and valid measures of IA/CA and co-morbid mental symptoms (for example social anxiety, depression) will be assessed prior to the beginning, in the middle, at the end, and 6 months after completion of treatment. Discussion A treatment of IA/CA will establish efficacy and is desperately needed. As this is the first trial to determine efficacy of a disorder specific treatment, a wait list control group will be implemented. Pros and cons of the design were discussed. Trial Registration ClinicalTrials (NCT01434589) PMID:22540330

  12. Does the Addition of Cetuximab to Radiochemotherapy Improve Outcome of Patients with Locally Advanced Rectal Cancer? Long-Term Results from Phase II Trials

    Directory of Open Access Journals (Sweden)

    M. Kripp

    2015-01-01

    Full Text Available Purpose. The addition of cetuximab to radiochemotherapy (RCT failed to improve complete response rates in locally advanced rectal cancer (LARC. We report the long-term results in patients treated within two sequential clinical trials. Methods. Patients receiving neoadjuvant RCT using capecitabine and irinotecan (CapIri within a phase I/II trial or CapIri + cetuximab within a phase II trial were evaluated for analysis of disease-free survival (DFS and overall survival (OS. KRAS exon 2 mutational status had been analyzed in patients receiving cetuximab. Results. 37 patients from the CapIri trial and 49 patients from the CapIri-cetuximab treatment group were evaluable. Median follow-up time was 75.2 months. The 5-year DFS rate was 82% (CapIri and 79% (CapIri-cetuximab (P=0.62. The median OS was 127.4 months. 5-year OS was 73% for both groups (CapIri and CapIri-cetuximab (P=0.61. No significant difference in DFS (P=0.86 or OS (P=0.39 was noticed between patients receiving CapIri and those receiving CapIri-cetuximab with KRAS wild-type tumors. Conclusions. As the addition of cetuximab did not improve neither DFS nor OS it should not play a role in the perioperative treatment of patients with LARC, not even of patients with (KRAS WT tumors.

  13. Long-term Diet and Biomarker Changes after a Short-term Intervention among Hispanic Breast Cancer Survivors: The ¡Cocinar Para Su Salud! Randomized Controlled Trial.

    Science.gov (United States)

    Greenlee, Heather; Ogden Gaffney, Ann; Aycinena, A Corina; Koch, Pam; Contento, Isobel; Karmally, Wahida; Richardson, John M; Shi, Zaixing; Lim, Emerson; Tsai, Wei-Yann; Santella, Regina M; Blaner, William S; Clugston, Robin D; Cremers, Serge; Pollak, Susan; Sirosh, Iryna; Crew, Katherine D; Maurer, Matthew; Kalinsky, Kevin; Hershman, Dawn L

    2016-11-01

    Among Hispanic breast cancer survivors, we examined the long-term effects of a short-term culturally based dietary intervention on increasing fruits/vegetables (F/V), decreasing fat, and changing biomarkers associated with breast cancer recurrence risk. Spanish-speaking women (n = 70) with a history of stage 0-III breast cancer who completed treatment were randomized to ¡Cocinar Para Su Salud! (n = 34), a culturally based 9-session program (24 hours over 12 weeks, including nutrition education, cooking classes, and food-shopping field trips), or a control group (n = 36, written dietary recommendations for breast cancer survivors). Diet recalls, fasting blood, and anthropometric measures were collected at baseline, 6, and 12 months. We report changes between groups at 12 months in dietary intake and biomarkers using 2-sample Wilcoxon t tests and generalized estimating equation (GEE) models. At 12 months, the intervention group compared with the control group reported higher increases in mean daily F/V servings (total: +2.0 vs. -0.4; P Salud! program was effective at increasing long-term F/V intake in Hispanic breast cancer survivors and changed biomarkers associated with breast cancer recurrence risk. It is possible for short-term behavioral interventions to have long-term effects on behaviors and biomarkers in minority cancer patient populations. Results can inform future study designs. Cancer Epidemiol Biomarkers Prev; 25(11); 1491-502. ©2016 AACR. ©2016 American Association for Cancer Research.

  14. Long-term effectiveness of mailed nicotine replacement therapy: study protocol of a randomized controlled trial 5-year follow-up.

    Science.gov (United States)

    Kushnir, Vladyslav; Selby, Peter; Zawertailo, Laurie; Tyndale, Rachel F; Leatherdale, Scott T; Cunningham, John A

    2017-07-18

    Our group recently completed a randomized controlled trial, evaluating the efficacy of providing 5 weeks of free nicotine replacement therapy (NRT; in the form of the nicotine patch) by expedited postal mail without behavioral assistance to regular adult smokers interested in receiving it. The findings revealed that mailed provision of nicotine patches resulted in more than a doubling of quit rates at a six-month follow-up compared to a no intervention control group. While this trial provided evidence for the effectiveness of mailed nicotine patches in promoting cessation, the findings speak only to the short term effectiveness of this approach. As relapse to smoking is known to occur beyond the 6 month period, it is important to evaluate whether the net benefit of NRT in naturalistic settings can be maintained long-term. The present study aims to perform a 5-year follow-up survey of participants in the original trial to evaluate the long-term effectiveness of mailed NRT. Trained interviewers will contact participants in the randomized controlled trial 5 years post-enrollment. A total of 924 participants will be eligible to be contacted. Interviewers will first assess participants' smoking status and their level of nicotine dependence. Participants reporting not currently smoking will be asked whether they have smoked tobacco, even a puff, in the last 30 days (primary outcome measure: 30-day point prevalence abstinence), past 6 months (secondary outcome measure: prolonged 6-month abstinence), and since the 8-week follow-up survey (secondary outcome measure: > 4 year continuous abstinence). Interviewers will be blind to experimental condition at the time the primary outcome measure will be assessed. It is hypothesized that participants who received nicotine patches at baseline will display significantly higher quit rates at the 5-year follow-up as compared to participants who did not receive nicotine patches at baseline. If the study finds that the mailed

  15. Predictors of Short- and Long-Term Attrition From the Parents as Agents of Change Randomized Controlled Trial for Managing Pediatric Obesity.

    Science.gov (United States)

    Spence, Nicholas D; Newton, Amanda S; Keaschuk, Rachel A; Ambler, Kathryn A; Jetha, Mary M; Holt, Nicholas L; Rosychuk, Rhonda J; Spence, John C; Sharma, Arya M; Ball, Geoff D C

    Attrition in pediatric weight management is a substantial problem. This study examined factors associated with short- and long-term attrition from a lifestyle and behavioral intervention for parents of children with overweight or obesity. Fifty-two families with children ages 6 to 12 years old and body mass index at or above the 85th percentile participated in a randomized controlled trial focused on parents, comparing parent-based cognitive behavioral therapy with parent-based psychoeducation for pediatric weight management. We examined program attrition using two clinical phases of the intervention: short-term and long-term attrition, modeled using the general linear model. Predictors included intervention type, child/parent weight status, sociodemographic factors, and health of the family system. Higher self-assessed health of the family system was associated with lower short-term attrition; higher percentage of intervention sessions attended by parents was associated with lower long-term attrition. Different variables were significant in our short- and long-term models. Attrition might best be conceptualized based on short- and long-term phases of clinical, parent-based interventions for pediatric weight management. Copyright © 2016 National Association of Pediatric Nurse Practitioners. Published by Elsevier Inc. All rights reserved.

  16. Remediating Organizational Functioning in Children with ADHD: Immediate and Long-Term Effects from a Randomized Controlled Trial

    Science.gov (United States)

    Abikoff, Howard; Gallagher, Richard; Wells, Karen C.; Murray, Desiree W.; Huang, Lei; Lu, Feihan; Petkova, Eva

    2013-01-01

    Objective: The study compared the efficacy of 2 behavioral interventions to ameliorate organization, time management, and planning (OTMP) difficulties in 3rd- to 5th-grade children with attention-deficit/hyperactivity disorder (ADHD). Method: In a dual-site randomized controlled trial, 158 children were assigned to organizational skills training…

  17. Long-term side effects of radiotherapy for pediatric localized neuroblastoma. Results from clinical trials NB90 and NB94

    Energy Technology Data Exchange (ETDEWEB)

    Ducassou, Anne [Institut Claudius Regaud, Departement de Radiotherapie, Toulouse (France); Gambart, Marion; Munzer, Caroline; Rubie, Herve [Hopital des Enfants, Departement d' Onco-Hematologie Pediatrique, Toulouse (France); Padovani, Laetitia [Centre Hospitalier et Universitaire, Departement de Radiotherapie, Marseille (France); Carrie, Christian; Claude, Line [Centre Leon Berard, IHOP, Departement de Radiotherapie, Lyon (France); Haas-Kogan, Daphne [University of California, Department of Radiation Oncology, San Francisco (United States); Bernier-Chastagner, Valerie [Centre Alexis Vautrin, Departement de Radiotherapie, Nancy (France); Demoor, Charlotte [Centre Rene Gauducheau, Departement de Radiotherapie, Nantes (France); Helfre, Sylvie [Institut Curie, Departement de Radiotherapie, Paris (France); Bolle, Stephanie [Institut Gustave Roussy, Departement de Radiotherapie, Villejuif (France); Leseur, Julie [Centre Eugene Marquis, Departement de Radiotherapie, Rennes (France); Huchet, Aymeri [Centre Hospitalier et Universitaire, Departement de Radiotherapie, Bordeaux (France); Valteau-Couanet, Dominique [Institut Gustave Roussy, Departement d' Onco-Hematologie Pediatrique, Villejuif (France); Schleiermacher, Gudrun [Institut Curie, Departement d' Onco-Hematologie Pediatrique, Paris (France); Coze, Carole [Aix-Marseille Univ et APHM, Hopital d' Enfants de la Timone, Departement d' hemato-Oncologie Pediatrique, Marseille (France); Defachelles, Anne-Sophie [Centre Oscar Lambret, Departement d' Onco-Hematologie Pediatrique, Lille (France); Marabelle, Aurelien [IHOP, Departement d' Onco-Hematologie Pediatrique, Lyon (France); Ducassou, Stephane [Hopital des Enfants, Departement d' Onco-Hematologie Pediatrique, Bordeaux (France); Devalck, Christine [Hopital des enfants Reine Fabiola, Departement d' Onco-hematologie Pediatrique, Bruxelles (Belgium); Gandemer, Virginie [Centre hospitalier, Departement d' Onco-Hematologie Pediatrique, Rennes (France); Munzer, Martine [Centre hospitalier, Departement d' Onco-hematologie Pediatrique, Reims (France); Laprie, Anne [Institut Claudius Regaud, Departement de Radiotherapie, Toulouse (France); Universite Toulouse III Paul Sabatier, Toulouse (France); INSERM, Toulouse (France); Collaboration: Neuroblastoma study group and radiotherapy group of the French Society of Children with Cancer (SFCE)

    2015-07-15

    Neuroblastoma (NB) is the most frequent indication for extracranial pediatric radiotherapy. As long-term survival of high-risk localized NB has greatly improved, we reviewed treatment-related late toxicities in pediatric patients who received postoperative radiotherapy (RT) for localized NB within two French prospective clinical trials: NB90 and NB94. From 1990-2000, 610 children were enrolled. Among these, 35 were treated with induction chemotherapy, surgery, and RT. The recommended RT dose was 24 Gy at ≤ 2 years, 34 Gy at > 2 years, ± a 5 Gy boost in both age groups. The 22 patients still alive after 5 years were analyzed. The median follow-up time was 14 years (range 5-21 years). Late effects after therapy occurred in 73 % of patients (16/22), within the RT field for 50 % (11/22). The most frequent in-field effects were musculoskeletal abnormalities (n = 7) that occurred only with doses > 31 Gy/1.5 Gy fraction (p = 0.037). Other effects were endocrine in 3 patients and second malignancies in 2 patients. Four patients presented with multiple in-field late effects only with doses > 31 Gy. After a median follow-up of 14 years, late effects with multimodality treatment were frequent. The most frequent effects were musculoskeletal abnormalities and the threshold for their occurrence was 31 Gy. (orig.) [German] Das Neuroblastom (NB) ist die haeufigste Indikation fuer eine extrakranielle paediatrische Strahlentherapie. Da sich beim lokalisierten Hochrisiko-NB das langfristige Ueberleben stark verbessert hat, ueberprueften wir die behandlungsbedingte spaete Toxizitaet bei paediatrischen Patienten, die im Rahmen zweier prospektiver klinischer Studien in Frankreich (NB90 und NB94) eine postoperative Strahlentherapie (RT) bei lokalisiertem NB erhalten hatten. Von 1990-2000 wurden 610 Kinder eingeschlossen. Von diesen wurden 35 mit Chemotherapie, Chirurgie und RT behandelt. Die empfohlene Bestrahlungsdosis war 24 Gy bei ≤ 2 Jahren, 34 Gy bei > 2 Jahren, ± 5-Gy

  18. Identifying attachment ruptures underlying severe music performance anxiety in a professional musician undertaking an assessment and trial therapy of Intensive Short-Term Dynamic Psychotherapy (ISTDP).

    Science.gov (United States)

    Kenny, Dianna T; Arthey, Stephen; Abbass, Allan

    2016-01-01

    Kenny has proposed that severe music performance anxiety that is unresponsive to usual treatments such as cognitive-behaviour therapy may be one manifestation of unresolved attachment ruptures in early life. Intensive Short-Term Dynamic Psychotherapy specifically targets early relationship trauma. Accordingly, a trial of Intensive Short-Term Dynamic Psychotherapy with severely anxious musicians was implemented to assess whether resolution of attachment ruptures resulted in clinically significant relief from music performance anxiety. Volunteer musicians participating in a nationally funded study were screened for MPA severity. Those meeting the critical cut-off score on the Kenny Music Performance Anxiety Inventory were offered a trial of Intensive Short-Term Dynamic Psychotherapy. In this paper, we present the theoretical foundations and rationale for the treatment approach, followed by sections of a verbatim transcript and process analysis of the assessment phase of treatment that comprised a 3-h trial therapy session. The 'case' was a professional orchestral musician (male, aged 55) who had suffered severe music performance anxiety over the course of his entire career, which spanned more than 30 years at the time he presented for treatment following his failure to secure a position at audition. The participant was able to access the pain, rage and grief associated with unresolved attachment ruptures with both parents that demonstrated the likely nexus between early attachment trauma and severe music performance anxiety. Intensive Short-Term Dynamic Psychotherapy is a potentially cost-effective treatment for severe music performance anxiety. Further research using designs with higher levels of evidence are required before clinical recommendations can be made for the use of this therapy with this population.

  19. Long-term results of the European achalasia trial: a multicentre randomised controlled trial comparing pneumatic dilation versus laparoscopic Heller myotomy

    NARCIS (Netherlands)

    Moonen, An; Annese, Vito; Belmans, Ann; Bredenoord, Albert J.; Bruley des Varannes, Stanislas; Costantini, Mario; Dousset, Bertrand; Elizalde, J. I.; Fumagalli, Uberto; Gaudric, Marianne; Merla, Antonio; Smout, Andre J.; Tack, Jan; Zaninotto, Giovanni; Busch, Olivier R.; Boeckxstaens, Guy E.

    2016-01-01

    Achalasia is a chronic motility disorder of the oesophagus for which laparoscopic Heller myotomy (LHM) and endoscopic pneumodilation (PD) are the most commonly used treatments. However, prospective data comparing their long-term efficacy is lacking. 201 newly diagnosed patients with achalasia were

  20. Operative technique at caesarean delivery and risk of complete uterine rupture in a subsequent trial of labour at term. A registry case-control study

    DEFF Research Database (Denmark)

    Thisted, Dorthe L. A.; Mortensen, Laust H.; Hvidman, Lone

    2017-01-01

    Objective: To estimate the relation of single-layer closure at previous caesarean delivery, and other pre-labour and intra-partum risk factors for complete uterine rupture in trial of vaginal birth after a caesarean (TOLAC) at term. Study design: Population-based case-control study. We identified...... all women (n = 39 742) recorded in the Danish Medical Birth Registry (DMBR) during a 12-year period (1997–2008) with a singleton pregnancy at term and TOLAC. Among these, all women with a complete uterine rupture were identified (cases). Information from the registry was validated against medical...... of uterine rupture. Conclusion: Single-layer uterine closure did not remain significantly associated to uterine rupture during TOLAC at term after adjustment for confounding factors. Induction of labour with an unfavourable cervix, birth weight ≥ 4000g and indicators of prolonged labour were all major risk...

  1. A randomized clinical trial of cognitive behavioural therapy versus short-term psychodynamic psychotherapy versus no intervention for patients with hypochondriasis

    DEFF Research Database (Denmark)

    Sørensen, Per; Birket-Smith, M; Wattar, U

    2011-01-01

    Hypochondriasis is common in the clinic and in the community. Cognitive behavioural therapy (CBT) has been found to be effective in previous trials. Psychodynamic psychotherapy is a treatment routinely offered to patients with hypochondriasis in many countries, including Denmark. The aim of this ......Hypochondriasis is common in the clinic and in the community. Cognitive behavioural therapy (CBT) has been found to be effective in previous trials. Psychodynamic psychotherapy is a treatment routinely offered to patients with hypochondriasis in many countries, including Denmark. The aim...... of this study was to test CBT for hypochondriasis in a centre that was not involved in its development and compare both CBT and short-term psychodynamic psychotherapy (STPP) to a waiting-list control and to each other. CBT was modified by including mindfulness and group therapy sessions, reducing the therapist...

  2. Short and long term effects of left and bilateral repetitive transcranial magnetic stimulation in schizophrenia patients with auditory verbal hallucinations: a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Leonie Bais

    Full Text Available BACKGROUND: Repetitive transcranial magnetic stimulation of the left temporo-parietal junction area has been studied as a treatment option for auditory verbal hallucinations. Although the right temporo-parietal junction area has also shown involvement in the genesis of auditory verbal hallucinations, no studies have used bilateral stimulation. Moreover, little is known about durability effects. We studied the short and long term effects of 1 Hz treatment of the left temporo-parietal junction area in schizophrenia patients with persistent auditory verbal hallucinations, compared to sham stimulation, and added an extra treatment arm of bilateral TPJ area stimulation. METHODS: In this randomized controlled trial, 51 patients diagnosed with schizophrenia and persistent auditory verbal hallucinations were randomly allocated to treatment of the left or bilateral temporo-parietal junction area or sham treatment. Patients were treated for six days, twice daily for 20 minutes. Short term efficacy was measured with the Positive and Negative Syndrome Scale (PANSS, the Auditory Hallucinations Rating Scale (AHRS, and the Positive and Negative Affect Scale (PANAS. We included follow-up measures with the AHRS and PANAS at four weeks and three months. RESULTS: The interaction between time and treatment for Hallucination item P3 of the PANSS showed a trend for significance, caused by a small reduction of scores in the left group. Although self-reported hallucination scores, as measured with the AHRS and PANAS, decreased significantly during the trial period, there were no differences between the three treatment groups. CONCLUSION: We did not find convincing evidence for the efficacy of left-sided rTMS, compared to sham rTMS. Moreover, bilateral rTMS was not superior over left rTMS or sham in improving AVH. Optimizing treatment parameters may result in stronger evidence for the efficacy of rTMS treatment of AVH. Moreover, future research should consider

  3. A randomized clinical trial evaluating plasma rich in growth factors (PRGF-Endoret) versus hyaluronic acid in the short-term treatment of symptomatic knee osteoarthritis.

    Science.gov (United States)

    Sánchez, Mikel; Fiz, Nicolás; Azofra, Juan; Usabiaga, Jaime; Aduriz Recalde, Enmanuel; Garcia Gutierrez, Antonio; Albillos, Javier; Gárate, Ramón; Aguirre, Jose Javier; Padilla, Sabino; Orive, Gorka; Anitua, Eduardo

    2012-08-01

    This multicenter, double-blind clinical trial evaluated and compared the efficacy and safety of PRGF-Endoret (BTI Biotechnology Institute, Vitoria-Gasteiz, Spain), an autologous biological therapy for regenerative purposes, versus hyaluronic acid (HA) as a short-term treatment for knee pain from osteoarthritis. We randomly assigned 176 patients with symptomatic knee osteoarthritis to receive infiltrations with PRGF-Endoret or with HA (3 injections on a weekly basis). The primary outcome measure was a 50% decrease in knee pain from baseline to week 24. As secondary outcomes, we also assessed pain, stiffness, and physical function using the Western Ontario and McMaster Universities Osteoarthritis Index; the rate of response using the criteria of the Outcome Measures for Rheumatology Committee and Osteoarthritis Research Society International Standing Committee for Clinical Trials Response Criteria Initiative (OMERACT-OARSI); and safety. The mean age of the patients was 59.8 years, and 52% were women. Compared with the rate of response to HA, the rate of response to PRGF-Endoret was 14.1 percentage points higher (95% confidence interval, 0.5 to 27.6; P = .044). Regarding the secondary outcome measures, the rate of response to PRGF-Endoret was higher in all cases, although no significant differences were reached. Adverse events were mild and evenly distributed between the groups. Plasma rich in growth factors showed superior short-term results when compared with HA in a randomized controlled trial, with a comparable safety profile, in alleviating symptoms of mild to moderate osteoarthritis of the knee. Level I, randomized controlled multicenter trial. Copyright © 2012 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

  4. Short-term influence of cataract surgery on circadian biological rhythm and related health outcomes (CLOCK-IOL trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Saeki, Keigo; Obayashi, Kenji; Nishi, Tomo; Miyata, Kimie; Maruoka, Shinji; Ueda, Tetsuo; Okamoto, Masahiro; Hasegawa, Taiji; Matsuura, Toyoaki; Tone, Nobuhiro; Ogata, Nahoko; Kurumatani, Norio

    2014-12-29

    Light information is the most important cue of circadian rhythm which synchronizes biological rhythm with external environment. Circadian misalignment of biological rhythm and external environment is associated with increased risk of depression, insomnia, obesity, diabetes, cardiovascular disease, and cancer. Increased light transmission by cataract surgery may improve circadian misalignment and related health outcomes. Although some observational studies have shown improvement of depression and insomnia after cataract surgery, randomized controlled trials are lacking. We will conduct a parallel-group, assessor-blinded, simple randomized controlled study comparing a cataract surgery group at three months after surgery with a control group to determine whether cataract surgery improves depressive symptoms, sleep quality, body mass regulation, and glucose and lipid metabolism. We will recruit patients who are aged 60 years and over, scheduled to receive their first cataract surgery, and have grade 2 or higher nuclear opacification as defined by the lens opacities classification system III. Exclusion criteria will be patients with major depression, severe corneal opacity, severe glaucoma, vitreous haemorrhage, proliferative diabetic retinopathy, macular oedema, age-related macular degeneration, and patients needing immediate or combined cataract surgery. After baseline participants will be randomized to two groups. Outcomes will be measured at three months after surgery among the intervention group, and three months after baseline among the control group. We will assess depressive symptoms as a primary outcome, using the short version geriatric depression scale (GDS-15). Secondary outcomes will be subjective and actigraph-measured sleep quality, sleepiness, glycated haemoglobin, fasting plasma glucose and triglyceride, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, body mass index, abdominal circumference, circadian rhythms of physical

  5. Clinical Trials

    Medline Plus

    Full Text Available ... Usually, a computer program makes the group assignments. Masking The term "masking" refers to not telling the clinical trial participants which treatment they're getting. Masking, or "blinding," helps avoid bias. For this reason, ...

  6. Clinical Trials

    Medline Plus

    Full Text Available ... patients. Usually, a computer program makes the group assignments. Masking The term "masking" refers to not telling ... questions to ask your doctor and the research staff, go to "How Do Clinical Trials Protect Participants?" ...

  7. Clinical Trials

    Medline Plus

    Full Text Available ... to preexisting differences between the patients. Usually, a computer program makes the group assignments. Masking The term " ... under way. For example, some trials are stopped early if benefits from a strategy or treatment are ...

  8. Efficacy of short-term high-dose statin in preventing contrast-induced nephropathy: a meta-analysis of seven randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Yongchuan Li

    Full Text Available A few studies focused on statin therapy as specific prophylactic measures of contrast-induced nephropathy have been published with conflicting results. In this meta-analysis of randomized controlled trials, we aimed to assess the effectiveness of short-term high-dose statin treatment for the prevention of CIN and clinical outcomes and re-evaluate of the potential benefits of statin therapy.We searched PubMed, OVID, EMBASE, Web of science and the Cochrane Central Register of Controlled Trials databases for randomized controlled trials comparing short-term high-dose statin treatment versus low-dose statin treatment or placebo for preventing CIN. Our outcome measures were the risk of CIN within 2-5 days after contrast administration and need for dialysis.Seven randomized controlled trials with a total of 1,399 patients were identified and analyzed. The overall results based on fixed-effect model showed that the use of short-term high-dose statin treatment was associated with a significant reduction in risk of CIN (RR =0.51, 95% CI 0.34-0.76, p =0.001; I(2 = 0%. The incidence of acute renal failure requiring dialysis was not significant different after the use of statin (RR = 0.33, 95% CI 0.05-2.10, p = 0.24; I(2 = 0%. The use of statin was not associated with a significant decrease in the plasma C-reactive protein level (SMD -0.64, 95% CI: -1.57 to 0.29, P = 0.18, I(2 = 97%.Although this meta-analysis supports the use of statin to reduce the incidence of CIN, it must be considered in the context of variable patient demographics. Only a limited recommendation can be made in favour of the use of statin based on current data. Considering the limitations of included studies, a large, well designed trial that incorporates the evaluation of clinically relevant outcomes in participants with different underlying risks of CIN is required to more adequately assess the role for statin in CIN prevention.

  9. Long-term results of a randomized trial in locally advanced rectal cancer: no benefit from adding a brachytherapy boost

    DEFF Research Database (Denmark)

    Appelt, Ane L; Vogelius, Ivan R; Pløen, John

    2014-01-01

    PURPOSE/OBJECTIVE(S): Mature data on tumor control and survival are presented from a randomized trial of the addition of a brachytherapy boost to long-course neoadjuvant chemoradiation therapy (CRT) for locally advanced rectal cancer. METHODS AND MATERIALS: Between March 2005 and November 2008, 248...... patients with T3-4N0-2M0 rectal cancer were prospectively randomized to either long-course preoperative CRT (50.4 Gy in 28 fractions, per oral tegafur-uracil and L-leucovorin) alone or the same CRT schedule plus a brachytherapy boost (10 Gy in 2 fractions). The primary trial endpoint was pathologic...... on stratification for tumor regression grade and resection margin status indicated the presence of response migration. CONCLUSIONS: Despite increased pathologic tumor regression at the time of surgery, we observed no benefit on late outcome. Improved tumor regression does not necessarily lead to a relevant clinical...

  10. Impact of weed control strategies on resistance evolution in Alopecurus myosuroides – a long-term field trial

    Directory of Open Access Journals (Sweden)

    Ulber, Lena

    2016-02-01

    Full Text Available The impact of various herbicide strategies on populations of Alopecurus myosuroides is investigated in a longterm field trial situated in Wendhausen (Germany since 2009. In the initial years of the field experiment, resistant populations were selected by means of repeated application of the same herbicide active ingredients. For the selection of different resistance profiles, herbicides with actives from different HRAC groups were used. The herbicide actives flupyrsulfuron, isoproturon und fenoxaprop-P were applied for two years on large plots. In a succeeding field trial starting in 2011, it was investigated if the now existing resistant field populations could be controlled by various herbicide strategies. Eight different strategies consisting of various herbicide combinations were tested. Resistance evolution was investigated by means of plant counts and molecular genetic analysis.

  11. Short-term hypertension management in community is associated with long-term risk of stroke and total death in China: A community controlled trial.

    Science.gov (United States)

    Wang, Zengwu; Hao, Guang; Wang, Xin; Wang, Wen; Chen, Weiwei; Zhu, Manlu

    2016-11-01

    It is not fully clear whether the effect of short-term management in community can reduce the long-term risk of stroke OBJECTIVES:: To evaluate whether short-term hypertension management is associated with long-term incidence of stroke and total death in community health centers in China. Community controlled trail. Six community health centers (4 active, 2 control) in China, patients with hypertension. Patients were treated with normally therapy method. Patients were treated oriented by the Guideline for hypertension management. Two centers (Hebei and Zhejiang) from the Hypertension Control in Community (HCC) Project, which was conducted from 2005 to 2008, were randomly selected for this study. Four thousand hypertensive patients from these centers, who were under management for one year in the baseline, were followed up in 2013. The electronic health record system (2005-2008) was used to identify 2000 hypertensive patients, who were not included in HCC but lived in comparable community health center in the same province, as the control group. All baseline and follow-up data were collected using standardized questionnaires for stroke outcomes. Stroke. Of the 6000 participants, 3787 (63.1%) were eligible for analysis. At the time of follow-up, the average BP was kept in the lower level than that in baseline, and the control rate was 59.3%. After propensity-score matching, 110 strokes (2.0% vs 4.6%) and 141 deaths (1.4% vs 3.8%) were noted in the matched intervention and control groups (1078 pairs), respectively. Patients in the intervention group were less likely to experience a stroke or die than those in the control group (hazard ratio [HR] = 0.40, 95% confidence interval [CI]: 0.26-0.62, P stroke in hypertensive patients.

  12. Heart rate at discharge and long-term prognosis following percutaneous coronary intervention in stable and acute coronary syndromes--results from the BASKET PROVE trial.

    Science.gov (United States)

    Jensen, Magnus Thorsten; Kaiser, Christoph; Sandsten, Karl Erik; Alber, Hannes; Wanitschek, Maria; Iversen, Allan; Jensen, Jan Skov; Pedersen, Sune; Soerensen, Rikke; Rickli, Hans; Zurek, Marzena; Fahrni, Gregor; Bertel, Osmund; De Servi, Stefano; Erne, Paul; Pfisterer, Matthias; Galatius, Søren

    2013-10-09

    Elevated heart rate (HR) is associated with mortality in a number of heart diseases. We examined the long-term prognostic significance of HR at discharge in a contemporary population of patients with stable angina (SAP), non-ST-segment elevation acute coronary syndromes (NSTE-ACS), and ST-segment elevation myocardial infarction (STEMI) revascularized with percutaneous coronary intervention (PCI). Patients from the BASKET-PROVE trial, an 11-center randomized all-comers trial comparing bare-metal and drug-eluting stenting in large coronary vessels, were included. Discharge HR was determined from a resting ECG. Long-term outcomes (7 days to 2 years) were evaluated for all-cause mortality and cardiovascular death and non-fatal myocardial infarction. A total of 2029 patients with sinus rhythm were included, 722 (35.6%) SAP, 647 (31.9%) NSTE-ACS, and 660 (32.5%) STEMI. Elevated discharge HR was associated significantly with all-cause mortality: when compared to a reference of 90 bpm. For cardiovascular death/myocardial infarction, a discharge HR >90 bpm was associated with a hazard ratio of 6.2 (2.5-15.5, pacute coronary syndromes an elevated discharge HR was independently associated with poor prognosis. Conversely, a HR <60 bpm at discharge was associated with a good long-term prognosis irrespective of indication for PCI. © 2013.

  13. Efficacy of short-term versus long-term chest tube drainage following talc slurry pleurodesis in patients with malignant pleural effusions: a randomised trial.

    Science.gov (United States)

    Goodman, Anna; Davies, Christopher W H

    2006-10-01

    Talc pleurodesis is commonly used in the palliative treatment of malignant pleural effusions but the shortest and most effective regime has not been determined. In particular, it is not clear when the intercostal drain should be removed following the insertion of sclerosant. We conducted a single-centre, randomised, open trial of drain removal at 24 h versus 72 h following talc slurry pleurodesis. The primary outcome measure was success of pleurodesis (no recurrence of effusion on chest radiograph at 1-month follow-up) and secondary outcome measures included length of hospital stay and mortality. We found no difference between recurrence of pleural effusion in those randomised to drain removal at 24 h and those randomised to drain removal at 72 h (p>0.5). However, length of stay was significantly reduced when the chest drain was removed at 24 h (4 days versus 8 days; p<0.01). Mortality did not differ between the two groups. We conclude that this shorter pleurodesis regime is safe and effective.

  14. Repairing the breech

    Directory of Open Access Journals (Sweden)

    Harry C. Boyte

    2012-04-01

    Full Text Available The main obstacle to genuine and productive partnerships between institutions of higher education and the professionals they prepare, on the one side, and communities, on the other, is a “knowledge war,” full of invisible hierarchies and exclusions, producing a hypercompetitive achievement culture. This knowledge war dramatically limits communities’ and citizens’ ability to act on the problems they face today. It also sharply erodes the power of higher education, professionals, and civic leaders to help shape the culture in democratic ways.We have to get beyond arrogant experts and aggrieved communities if we want to develop communities’ capacities to solve problems and also to generate a larger vision of a good society. Community is the living context for evaluating expert knowledge. But without engagement with other ways of knowing appeal to community knowledge can easily produce a Know-Nothing reaction to the larger world.If we are to build communities’ civic agency – capacities to work across differences to meet our common challenges – we need to democratize the politics of knowledge and end the knowledge war. This requires learning from effective community organizing the idea of “schools for public life,” where ordinary people develop skills, habits, and confidence of citizenship. It also means creating what might be called middle spaces, not owned by academics or professionals, but open to academic and scientific knowledge, where different ways of knowing and acting intermingle in creative ways. Middle spaces put science and academic knowledge in the mix, “on tap, not on top.” They also recognize the power and the limits of communal knowledge.Keywordscivic agency, cultural organizing, knowledge war

  15. Long-term outcomes and cost effectiveness of high-dose dexamethasone for cardiac surgery : A randomised trial

    NARCIS (Netherlands)

    Dieleman, J. M.; de Wit, G. A.; Nierich, A. P.; Rosseel, P. M.; van der Maaten, J. M.; Hofland, J.; Diephuis, J. C.; de Lange, F.; Boer, C.; Neslo, R. E.; Moons, K. G.; van Herwerden, L. A.; Tijssen, J. G.; Kalkman, C. J.; van Dijk, D.

    Prophylactic intra-operative administration of dexamethasone may improve short-term clinical outcomes in cardiac surgical patients. The purpose of this study was to evaluate long-term clinical outcomes and cost effectiveness of dexamethasone versus placebo. Patients included in the multicentre,

  16. Long-term outcomes and cost effectiveness of high-dose dexamethasone for cardiac surgery: a randomised trial

    NARCIS (Netherlands)

    Dieleman, J. M.; de Wit, G. A.; Nierich, A. P.; Rosseel, P. M.; van der Maaten, J. M.; Hofland, J.; Diephuis, J. C.; de Lange, F.; Boer, C.; Neslo, R. E.; Moons, K. G.; van Herwerden, L. A.; Tijssen, J. G.; Kalkman, C. J.; van Dijk, D.

    2017-01-01

    Prophylactic intra-operative administration of dexamethasone may improve short-term clinical outcomes in cardiac surgical patients. The purpose of this study was to evaluate long-term clinical outcomes and cost effectiveness of dexamethasone versus placebo. Patients included in the multicentre,

  17. Long-term benefit and cost-effectiveness analysis of screening for abdominal aortic aneurysms from a randomized controlled trial

    DEFF Research Database (Denmark)

    Lindholt, J S; Sørensen, J; Søgaard, Rikke

    2010-01-01

    The aim was to estimate long-term mortality benefits and cost-effectiveness of screening for abdominal aortic aneurysm (AAA) in men aged 64-73 years.......The aim was to estimate long-term mortality benefits and cost-effectiveness of screening for abdominal aortic aneurysm (AAA) in men aged 64-73 years....

  18. Progressive Resistance and Balance Training for Falls Prevention in Long-Term Residential Aged Care: A Cluster Randomized Trial of the Sunbeam Program.

    Science.gov (United States)

    Hewitt, Jennifer; Goodall, Stephen; Clemson, Lindy; Henwood, Timothy; Refshauge, Kathryn

    2018-04-01

    Falls prevention is an international priority, and residents of long-term aged care fall approximately 3 times more often than community dwellers. There is a relative scarcity of published trials in this setting. Our objective was to undertake a randomized controlled trial to test the effect of published best practice exercise in long-term residential aged care. The trial was designed to determine if combined high level balance and moderate intensity progressive resistance training (the Sunbeam Program) is effective in reducing the rate of falls in residents of aged care facilities. A cluster randomized controlled trial of 16 residential aged care facilities and 221 participants was conducted. The broad inclusion criterion was permanent residents of aged care. Exclusions were diagnosed terminal illness, no medical clearance, permanent bed- or wheelchair-bound status, advanced Parkinson's disease, or insufficient cognition to participate in group exercise. Assessments were taken at baseline, after intervention, and at 12 months. Randomization was performed by computer-generated sequence to receive either the Sunbeam program or usual care. A cluster refers to an aged care facility. The program consisted of individually prescribed progressive resistance training plus balance exercise performed in a group setting for 50 hours over a 25-week period, followed by a maintenance period for 6 months. The primary outcome measure was the rate of falls (number of falls and days followed up). Secondary outcomes included physical performance (Short Physical Performance Battery), quality of life (36-item Short-Form Health Survey), functional mobility (University of Alabama Life Space Assessment), fear of falling (Falls Efficacy Scale International), and cognition (Addenbrooke's Cognitive Evaluation-revised). The rate of falls was reduced by 55% in the exercise group (incidence rate ratio = 0.45, 95% confidence interval 0.17-0.74); an improvement was also seen in physical

  19. Regulatory competence and social communication in term and preterm infants at 12 months corrected age. Results from a randomized controlled trial.

    Science.gov (United States)

    Olafsen, Kåre S; Rønning, John A; Handegård, Bjørn Helge; Ulvund, Stein Erik; Dahl, Lauritz Bredrup; Kaaresen, Per Ivar

    2012-02-01

    Temperamental regulatory competence and social communication in term and preterm infants at 12 months corrected age was studied in a randomized controlled intervention trial aimed at enhancing maternal sensitive responsiveness. Surviving infants communication with the Early Social Communication Scales. Preterm intervention infants with low regulatory competence had higher responding to joint attention than preterm control infants. A sensitizing intervention may moderate the association between temperament and social communication, and thus allow an alternative functional outlet for preterm infants low in regulatory competence. The finding may have implications for conceptualizations of the role of early sensitizing interventions in promoting important developmental outcomes for premature infants. Copyright © 2011 Elsevier Inc. All rights reserved.

  20. Evaluation of the leucine incorporation technique for detection of pollution-induced community tolerance to copper in a long-term agricultural field trial with urban waste fertilizers

    DEFF Research Database (Denmark)

    Lekfeldt, Jonas Duus Stevens; Magid, Jakob; Holm, Peter Engelund

    2014-01-01

    increased bacterial community tolerance to Cu was observed for soils amended with organic waste fertilizers and was positively correlated with total soil Cu. However, metal speciation and whole-cell bacterial biosensor analysis demonstrated that the observed PICT responses could be explained entirely by Cu......Copper (Cu) is known to accumulate in agricultural soils receiving urban waste products as fertilizers. We here report the use of the leucine incorporation technique to determine pollution-induced community tolerance (Leu-PICT) to Cu in a long-term agricultural field trial. A significantly...

  1. Prevention and treatment of long-term social disability amongst young people with emerging severe mental illness with social recovery therapy (The PRODIGY Trial): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Fowler, David; French, Paul; Banerjee, Robin; Barton, Garry; Berry, Clio; Byrne, Rory; Clarke, Timothy; Fraser, Rick; Gee, Brioney; Greenwood, Kathryn; Notley, Caitlin; Parker, Sophie; Shepstone, Lee; Wilson, Jon; Yung, Alison R; Hodgekins, Joanne

    2017-07-11

    Young people who have social disability associated with severe and complex mental health problems are an important group in need of early intervention. Their problems often date back to childhood and become chronic at an early age. Without intervention, the long-term prognosis is often poor and the economic costs very large. There is a major gap in the provision of evidence-based interventions for this group, and therefore new approaches to detection and intervention are needed. This trial provides a definitive evaluation of a new approach to early intervention with young people with social disability and severe and complex mental health problems using social recovery therapy (SRT) over a period of 9 months to improve mental health and social recovery outcomes. This is a pragmatic, multi-centre, single blind, superiority randomised controlled trial. It is conducted in three sites in the UK: Sussex, Manchester and East Anglia. Participants are aged 16 to 25 and have both persistent and severe social disability (defined as engaged in less than 30 hours per week of structured activity) and severe and complex mental health problems. The target sample size is 270 participants, providing 135 participants in each trial arm. Participants are randomised 1:1 using a web-based randomisation system and allocated to either SRT plus optimised treatment as usual (enhanced standard care) or enhanced standard care alone. The primary outcome is time use, namely hours spent in structured activity per week at 15 months post-randomisation. Secondary outcomes assess typical mental health problems of the group, including subthreshold psychotic symptoms, negative symptoms, depression and anxiety. Time use, secondary outcomes and health economic measures are assessed at 9, 15 and 24 months post-randomisation. This definitive trial will be the first to evaluate a novel psychological treatment for social disability and mental health problems in young people presenting with social

  2. Effects of a manualized short-term treatment of internet and computer game addiction (STICA): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Jäger, Susanne; Müller, Kai W; Ruckes, Christian; Wittig, Tobias; Batra, Anil; Musalek, Michael; Mann, Karl; Wölfling, Klaus; Beutel, Manfred E

    2012-04-27

    In the last few years, excessive internet use and computer gaming have increased dramatically. Salience, mood modification, tolerance, withdrawal symptoms, conflict, and relapse have been defined as diagnostic criteria for internet addiction (IA) and computer addiction (CA) in the scientific community. Despite a growing number of individuals seeking help, there are no specific treatments of established efficacy. This clinical trial aims to determine the effect of the disorder-specific manualized short-term treatment of IA/CA (STICA). The cognitive behavioural treatment combines individual and group interventions with a total duration of 4 months. Patients will be randomly assigned to STICA treatment or to a wait list control group. Reliable and valid measures of IA/CA and co-morbid mental symptoms (for example social anxiety, depression) will be assessed prior to the beginning, in the middle, at the end, and 6 months after completion of treatment. A treatment of IA/CA will establish efficacy and is desperately needed. As this is the first trial to determine efficacy of a disorder specific treatment, a wait list control group will be implemented. Pros and cons of the design were discussed. ClinicalTrials (NCT01434589).

  3. Long-Term Outcome of Cognitive Behavior Therapy for Body Dysmorphic Disorder: A Naturalistic Case Series of 1 to 4 Years After a Controlled Trial.

    Science.gov (United States)

    Veale, David; Miles, Sarah; Anson, Martin

    2015-11-01

    There is some evidence for the efficacy of cognitive behavior therapy (CBT) for body dysmorphic disorder (BDD) after 1 to 6months but none in the long term. The aim of this study was to follow up the participants in a randomized controlled trial of CBT versus anxiety management to determine whether or not the treatment gains were maintained over time. Thirty of the original 39 participants who had CBT were followed up over 1 to 4years and assessed using a number of clinician and self-report measures, which included the primary outcome measure of the Yale-Brown Obsessive Compulsive Scale modified for BDD. Outcome scores generally maintained over time from end of treatment to long-term follow-up. There was a slight deterioration from n=20 (51.3%) to n=18 (46.2%) who met improvement criteria at long-term follow-up. Eleven (28.2%) were in full remission and 22 (56.4%) were in partial remission. The gains made were generally maintained at long-term follow-up. However, there were a significant number of participants who maintained chronic symptoms after treatment and may need a longer-term or more complex intervention and active medication management. Copyright © 2015. Published by Elsevier Ltd.

  4. Short- and long-term risks of cardiovascular disease following radiotherapy in rectal cancer in four randomized controlled trials and a population-based register.

    Science.gov (United States)

    Chen, Lingjing; Eloranta, Sandra; Martling, Anna; Glimelius, Ingrid; Neovius, Martin; Glimelius, Bengt; Smedby, Karin E

    2018-03-01

    A population-based cohort and four randomized trials enriched with long-term register data were used to clarify if radiotherapy in combination with rectal cancer surgery is associated with increased risks of cardiovascular disease (CVD). We identified 14,901 rectal cancer patients diagnosed 1995-2009 in Swedish nationwide registers, of whom 9227 were treated with preoperative radiotherapy. Also, we investigated 2675 patients with rectal cancer previously randomized to preoperative radiotherapy or not followed by surgery in trials conducted 1980-1999. Risks of CVD overall and subtypes were estimated based on prospectively recorded hospital visits during relapse-free follow-up using multivariable Cox regression. Maximum follow-up was 18 and 33 years in the register and trials, respectively. We found no association between preoperative radiotherapy and overall CVD risk in the register (Incidence Rate Ratio, IRR = 0.99, 95% confidence interval (CI) 0.92-1.06) or in the pooled trials (IRR = 1.07, 95% CI 0.93-1.24). We noted an increased risk of venous thromboembolism among irradiated patients in both cohorts (IRR register  = 1.41, 95% CI 1.15-2.72; IRR trials  = 1.41, 95% CI 0.97-2.04), that remained during the first 6 months following surgery among patients treated 2006-2009, after the introduction of antithrombotic treatment (IRR 6 months  = 2.30, 95% CI 1.01-5.21). However, the absolute rate difference of venous thromboembolism attributed to RT was low (10 cases per 1000 patients and year). Preoperative radiotherapy did not affect rectal cancer patients' risk of CVD overall. Although an excess risk of short-term venous thromboembolism was noted, the small increase in absolute numbers does not call for general changes in routine prophylactic treatment, but might do so for patients already at high risk of venous thromboembolism. Copyright © 2017 Elsevier B.V. All rights reserved.

  5. Long-term treatment with probiotics in primary care patients with irritable bowel syndrome--a randomised, double-blind, placebo controlled trial

    DEFF Research Database (Denmark)

    Begtrup, Luise Mølenberg; de Muckadell, Ove B Schaffalitzky; Kjeldsen, Jens

    2013-01-01

    OBJECTIVE. Meta-analyses have indicated effect of probiotics on irritable bowel syndrome (IBS). However, few long-term trials have been conducted and uncertainty remains as to effectiveness and long-term effect in a primary care setting. We aimed to investigate the effect of probiotics compared...... with placebo in the management of IBS in primary care during a 6-month treatment period and with a 6-month follow-up. MATERIAL AND METHODS. We randomized IBS patients fulfilling Rome III criteria to receive two capsules twice daily either containing placebo or a probiotic mixture of Lactobacillus paracasei ssp....../67) in the probiotic group versus 41% (26/64) in the placebo group, p = 0.18. Overall we found no difference between the groups in change in gastrointestinal symptoms after treatment. Patients improved in HrQOL, but with no statistically significant difference between the groups. CONCLUSION. During a 6-month treatment...

  6. Effects of delayed cord clamping on residual placental blood volume, hemoglobin and bilirubin levels in term infants: a randomized controlled trial.

    Science.gov (United States)

    Mercer, J S; Erickson-Owens, D A; Collins, J; Barcelos, M O; Parker, A B; Padbury, J F

    2017-03-01

    The objective of the study was to measure the effects of a 5-min delay (DCC) versus immediate cord clamping (ICC) on residual placental blood volume (RPBV) at birth, and hemoglobin and serum bilirubin at 24 to 48 h of age. In this prospective randomized controlled trial, 73 women with term (37 to 41 weeks) singleton fetuses were randomized to DCC (⩾5 min; n=37) or ICC (protocol violations. Cord milking was the proxy for DCC (n=11) when the provider could not wait. Infants randomized to DCC compared with ICC had significantly less RPBV (20.0 versus 30.8 ml kg -1 , Phemoglobin levels (19.4 versus 17.8 g dl -1 , P=0.002) at 24 to 48 h, with no difference in bilirubin levels. Term infants had early hematological advantage of DCC without increases in hyperbilirubinemia or symptomatic polycythemia.

  7. Evaluation of bleeding following dental extraction in patients on long-term antiplatelet therapy: A clinical trial

    Directory of Open Access Journals (Sweden)

    K George Varghese

    2015-01-01

    Conclusion: Hence, we recommend routine single tooth extractions in patients on long-term antiplatelet medication, without interruption or alteration of their medication. Such patients do not have an increased risk of prolonged or excessive postoperative bleeding.

  8. Combined management of retroperitoneal sarcoma with dose intensification radiotherapy and resection: Long-term results of a prospective trial.

    LENUS (Irish Health Repository)

    Smith, Myles J F

    2014-01-07

    Late failure is a challenging problem following resection of retroperitoneal sarcoma (RPS). We investigated the effects of preoperative XRT plus dose escalation with early postoperative brachytherapy (BT) on long-term survival and recurrence in RPS.

  9. Pain relief effect of breast feeding and music therapy during heel lance for healthy-term neonates in China: a randomized controlled trial.

    Science.gov (United States)

    Zhu, Jiemin; Hong-Gu, He; Zhou, Xiuzhu; Wei, Haixia; Gao, Yaru; Ye, Benlan; Liu, Zuguo; Chan, Sally Wai-Chi

    2015-03-01

    to test the effectiveness of breast feeding (BF), music therapy (MT), and combined breast feeding and music therapy (BF+MT) on pain relief in healthy-term neonates during heel lance. randomised controlled trial. in the postpartum unit of one university-affiliated hospital in China from August 2013 to February 2014. among 288 healthy-term neonates recruited, 250 completed the trial. All neonates were undergoing heel lancing for metabolic screening, were breast fed, and had not been fed for the previous 30 minutes. all participants were randomly assigned into four groups - BF, MT, BF+MT, and no intervention - with 72 neonates in each group. Neonates in the control group received routine care. Neonates in the other three intervention groups received corresponding interventions five minutes before the heel lancing and throughout the whole procedure. Neonatal Infant Pain Scale (NIPS), latency to first cry, and duration of first crying. mean changes in NIPS scores from baseline over time was dependent on the interventions given. Neonates in the BF and combined BF+MT groups had significantly longer latency to first cry, shorter duration of first crying, and lower pain mean score during and one minute after heel lance, compared to the other two groups. No significant difference in pain response was found between BF groups with or without music therapy. The MT group did not achieve a significantly reduced pain response in all outcome measures. BF could significantly reduce pain response in healthy-term neonates during heel lance. MT did not enhance the effect of pain relief of BF. healthy-term neonates should be breast fed to alleviate pain during heel lance. There is no need for the additional input of classical music on breast feeding in clinic to relieve procedural pain. Nurses should encourage breast feeding to relieve pain during heel lance. Copyright © 2014 Elsevier Ltd. All rights reserved.

  10. A randomized controlled trial to establish effects of short-term rapamycin treatment in 24 middle-aged companion dogs.

    Science.gov (United States)

    Urfer, Silvan R; Kaeberlein, Tammi L; Mailheau, Susan; Bergman, Philip J; Creevy, Kate E; Promislow, Daniel E L; Kaeberlein, Matt

    2017-04-01

    Age is the single greatest risk factor for most causes of morbidity and mortality in humans and their companion animals. As opposed to other model organisms used to study aging, dogs share the human environment, are subject to similar risk factors, receive comparable medical care, and develop many of the same age-related diseases humans do. In this study, 24 middle-aged healthy dogs received either placebo or a non-immunosuppressive dose of rapamycin for 10 weeks. All dogs received clinical and hematological exams before, during, and after the trial and echocardiography before and after the trial. Our results showed no clinical side effects in the rapamycin-treated group compared to dogs receiving the placebo. Echocardiography suggested improvement in both diastolic and systolic age-related measures of heart function (E/A ratio, fractional shortening, and ejection fraction) in the rapamycin-treated dogs. Hematological values remained within the normal range for all parameters studied; however, the mean corpuscular volume (MCV) was decreased in rapamycin-treated dogs. Based on these results, we will test rapamycin on a larger dog cohort for a longer period of time in order to validate its effects on cardiac function and to determine whether it can significantly improve healthspan and reduce mortality in companion dogs.

  11. Prospective randomized evaluation of the watchman left atrial appendage closure device in patients with atrial fibrillation versus long-term warfarin therapy: The PREVAIL trial.

    Science.gov (United States)

    Belgaid, Djouhar Roufeida; Khan, Zara; Zaidi, Mariam; Hobbs, Adrian

    2016-09-15

    Assessing the safety and effectiveness of left atrial appendage (LAA) (pouch found in the upper chambers of the heart) occlusion, using the Watchman device compared to long term warfarin therapy (drug that reduces clot formation), in preventing the risk of stroke in patients with atrial fibrillation (most common type of irregular heart beat). 90% of strokes in atrial fibrillation arise from clots forming in this pouch. By mechanically blocking it using the device less clots are suggested to be formed. This is an alternative to taking warfarin especially in patients who cannot take it. 50 sites in the United States enrolled 407 participants. After being randomly allocated, the device group had 269 participants and warfarin group (comparator)had 138 participants. Patients with atrial fibrillation and at high risk of stroke were randomly allocated a group after they were deemed eligible. Patients in the device group had to take warfarin and aspirin for 45days till the complete closure of the LAA. The oral anticoagulant was followed by dual antiplatelet therapy until 6months and then ASA. Patients in the warfarin group have to take it for life and were continually monitored. The study ran for 26months. The trial assessed the rate of adverse events using three endpoints: The PREVAIL trial was not designed to show superiority, but non-inferiority. It met the safety endpoint and one efficacy endpoint for the watchman device compared to long term warfarin for overall efficacy of the device. The results established that LAA occlusion is not worse than warfarin intake for the prevention of stroke more than 1week after randomization. Compared to previous trials, the safety of the device has also improved. LAA occlusion is a reasonable alternative to chronic warfarin therapy in stroke prevention for patients with atrial fibrillation. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  12. Effects of Long-Term Acupuncture Treatment on Resting-State Brain Activity in Migraine Patients: A Randomized Controlled Trial on Active Acupoints and Inactive Acupoints

    Science.gov (United States)

    Zhao, Ling; Liu, Jixin; Zhang, Fuwen; Dong, Xilin; Peng, Yulin; Qin, Wei; Wu, Fumei; Li, Ying; Yuan, Kai; von Deneen, Karen M.; Gong, Qiyong; Tang, Zili; Liang, Fanrong

    2014-01-01

    Background Acupuncture has been commonly used for preventing migraine attacks and relieving pain during a migraine, although there is limited knowledge on the physiological mechanism behind this method. The objectives of this study were to compare the differences in brain activities evoked by active acupoints and inactive acupoints and to investigate the possible correlation between clinical variables and brain responses. Methods and Results A randomized controlled trial and resting-state functional magnetic resonance imaging (fMRI) were conducted. A total of eighty migraineurs without aura were enrolled to receive either active acupoint acupuncture or inactive acupoint acupuncture treatment for 8 weeks, and twenty patients in each group were randomly selected for the fMRI scan at the end of baseline and at the end of treatment. The neuroimaging data indicated that long-term active acupoint therapy elicited a more extensive and remarkable cerebral response compared with acupuncture at inactive acupoints. Most of the regions were involved in the pain matrix, lateral pain system, medial pain system, default mode network, and cognitive components of pain processing. Correlation analysis showed that the decrease in the visual analogue scale (VAS) was significantly related to the increased average Regional homogeneity (ReHo) values in the anterior cingulate cortex in the two groups. Moreover, the decrease in the VAS was associated with increased average ReHo values in the insula which could be detected in the active acupoint group. Conclusions Long-term active acupoint therapy and inactive acupoint therapy have different brain activities. We postulate that acupuncture at the active acupoint might have the potential effect of regulating some disease-affected key regions and the pain circuitry for migraine, and promote establishing psychophysical pain homeostasis. Trial Registration Chinese Clinical Trial Registry ChiCTR-TRC-13003635 PMID:24915066

  13. Effects of Short-Term Cognitive Remediation on Cognitive Dysfunction in Partially or Fully Remitted Individuals with Bipolar Disorder: Results of a Randomised Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Kirsa M Demant

    Full Text Available Cognitive dysfunction is common in bipolar disorder (BD but is not sufficiently addressed by current treatments. Cognitive remediation (CR may improve cognitive function in schizophrenia but no randomised controlled trial has investigated this intervention in BD. The present study aimed to investigate the effects of CR on persistent cognitive dysfunction in BD.Patients with BD in partial remission with cognitive complaints were randomised to 12 weeks group-based CR (n=23 or standard treatment (ST (n=23. Outcomes were improved verbal memory (primary, sustained attention, executive and psychosocial function (secondary and additional measures of cognitive and psychosocial function (tertiary. Participants were assessed at baseline and weeks 12 and 26.Of the 46 randomised participants five dropped out and one was excluded after baseline. CR (n=18 had no effect on primary or secondary measures of cognitive or psychosocial function compared with ST (n=22. However, CR improved subjective sharpness at week 12, and quality of life and verbal fluency at week 26 follow-up (tertiary outcomes. Although the trial turned out to have suboptimal statistical power for the primary outcome analysis, calculation of the 95% confidence interval showed that it was highly unlikely that an increase in sample size would have rendered any beneficial effects of CR vs. ST on the verbal memory.Short-term group-based CR did not seem to improve overall cognitive or psychosocial function in individuals with BD in full or partial remission. The present findings suggest that that longer-term, more intensive and individualised CR may be necessary to improve cognition in BD.ClinicalTrials.gov NCT01457235.

  14. Long-Term Results of a Randomized Trial in Locally Advanced Rectal Cancer: No Benefit From Adding a Brachytherapy Boost

    International Nuclear Information System (INIS)

    Appelt, Ane L.; Vogelius, Ivan R.; Pløen, John; Rafaelsen, Søren R.; Lindebjerg, Jan; Havelund, Birgitte M.; Bentzen, Søren M.; Jakobsen, Anders

    2014-01-01

    Purpose/Objective(s): Mature data on tumor control and survival are presented from a randomized trial of the addition of a brachytherapy boost to long-course neoadjuvant chemoradiation therapy (CRT) for locally advanced rectal cancer. Methods and Materials: Between March 2005 and November 2008, 248 patients with T3-4N0-2M0 rectal cancer were prospectively randomized to either long-course preoperative CRT (50.4 Gy in 28 fractions, per oral tegafur-uracil and L-leucovorin) alone or the same CRT schedule plus a brachytherapy boost (10 Gy in 2 fractions). The primary trial endpoint was pathologic complete response (pCR) at the time of surgery; secondary endpoints included overall survival (OS), progression-free survival (PFS), and freedom from locoregional failure. Results: Results for the primary endpoint have previously been reported. This analysis presents survival data for the 224 patients in the Danish part of the trial. In all, 221 patients (111 control arm, 110 brachytherapy boost arm) had data available for analysis, with a median follow-up time of 5.4 years. Despite a significant increase in tumor response at the time of surgery, no differences in 5-year OS (70.6% vs 63.6%, hazard ratio [HR] = 1.24, P=.34) and PFS (63.9% vs 52.0%, HR=1.22, P=.32) were observed. Freedom from locoregional failure at 5 years were 93.9% and 85.7% (HR=2.60, P=.06) in the standard and in the brachytherapy arms, respectively. There was no difference in the prevalence of stoma. Explorative analysis based on stratification for tumor regression grade and resection margin status indicated the presence of response migration. Conclusions: Despite increased pathologic tumor regression at the time of surgery, we observed no benefit on late outcome. Improved tumor regression does not necessarily lead to a relevant clinical benefit when the neoadjuvant treatment is followed by high-quality surgery

  15. Short-term efficacy of physical interventions in osteoarthritic knee pain. A systematic review and meta-analysis of randomised placebo-controlled trials

    Directory of Open Access Journals (Sweden)

    Bogen Bård

    2007-06-01

    Full Text Available Abstract Background Treatment efficacy of physical agents in osteoarthritis of the knee (OAK pain has been largely unknown, and this systematic review was aimed at assessing their short-term efficacies for pain relief. Methods Systematic review with meta-analysis of efficacy within 1–4 weeks and at follow up at 1–12 weeks after the end of treament. Results 36 randomised placebo-controlled trials (RCTs were identified with 2434 patients where 1391 patients received active treatment. 33 trials satisfied three or more out of five methodological criteria (Jadad scale. The patient sample had a mean age of 65.1 years and mean baseline pain of 62.9 mm on a 100 mm visual analogue scale (VAS. Within 4 weeks of the commencement of treatment manual acupuncture, static magnets and ultrasound therapies did not offer statistically significant short-term pain relief over placebo. Pulsed electromagnetic fields offered a small reduction in pain of 6.9 mm [95% CI: 2.2 to 11.6] (n = 487. Transcutaneous electrical nerve stimulation (TENS, including interferential currents, electro-acupuncture (EA and low level laser therapy (LLLT offered clinically relevant pain relieving effects of 18.8 mm [95% CI: 9.6 to 28.1] (n = 414, 21.9 mm [95% CI: 17.3 to 26.5] (n = 73 and 17.7 mm [95% CI: 8.1 to 27.3] (n = 343 on VAS respectively versus placebo control. In a subgroup analysis of trials with assumed optimal doses, short-term efficacy increased to 22.2 mm [95% CI: 18.1 to 26.3] for TENS, and 24.2 mm [95% CI: 17.3 to 31.3] for LLLT on VAS. Follow-up data up to 12 weeks were sparse, but positive effects seemed to persist for at least 4 weeks after the course of LLLT, EA and TENS treatment was stopped. Conclusion TENS, EA and LLLT administered with optimal doses in an intensive 2–4 week treatment regimen, seem to offer clinically relevant short-term pain relief for OAK.

  16. The long-term outcomes of interventions for the management of attention-deficit hyperactivity disorder in children and adolescents: a systematic review of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Parker J

    2013-09-01

    Full Text Available Jack Parker,1 Gill Wales,2 Nevyne Chalhoub,1 Val Harpin2 1Child and Adolescent Mental Health Service, Sheffield Children’s NHS Foundation Trust, Sheffield, UK; 2Paediatric Neurodisability, Ryegate Children’s Centre, Sheffield Children’s NHS Foundation Trust, Sheffield, UK Purpose: To systematically identify and review the currently available evidence on the long-term outcomes of recommended attention-deficit hyperactivity disorder (ADHD interventions following randomized controlled trials with children and young people. Method: A systematic search was conducted to identify trials >1 year in length using the following databases: CINAHL (January 1982– July 2012, MEDLINE (Ovid and Cambridge Scientific Abstracts [CSA], Psych info, Science Direct (Elsevier, and Cochrane Library. Hand searches of key journals in the subject, book chapters, and conference proceedings were also carried out. Relevant papers were critically appraised using the Cochrane risk of bias tool. Results: Eight controlled trials were identified as being relevant, of duration ranging from 1 year to 8 years (at follow up. The total number of participants in the studies was 1,057, of whom 579 (54.7% were from one cohort and included 26 different outcome measures. Results suggest there is moderate-to-high-level evidence that combined pharmacological and behavioral interventions, and pharmacological interventions alone can be effective in managing the core ADHD symptoms and academic performance at 14 months. However, the effect size may decrease beyond this period. Conclusion: This review has highlighted the paucity and limitations of the evidence investigating the long-term outcomes of recommended interventions for managing ADHD symptoms. There is little evidence to suggest that the effects observed over the relatively short term are maintained throughout longer periods of impairment. Furthermore, much of the existing evidence examining effectiveness beyond 12 months does not

  17. Long-term follow-up of a randomized clinical trial comparing Beger with pylorus-preserving Whipple procedure for chronic pancreatitis.

    Science.gov (United States)

    Müller, M W; Friess, H; Martin, D J; Hinz, U; Dahmen, R; Büchler, M W

    2008-03-01

    Duodenum-preserving pancreatic head resection according to Beger and the pylorus-preserving Whipple (ppWhipple) procedure were compared in patients with chronic pancreatitis (CP) in a randomized clinical trial. Perioperative data and short-term outcome have been reported previously. The present study evaluated long-term follow-up. Forty patients were enrolled originally, 20 in each group. Long-term follow-up included mortality, morbidity, pain status, occupational rehabilitation, quality of life (QoL), and endocrine and exocrine function at median follow-up of 7 and 14 years. One patient who had a ppWhipple procedure was lost to follow-up. There were five late deaths in each group. No differences were noted in pain status and exocrine pancreatic function. Loss of appetite was significantly worse in the ppWhipple group at 14 years' follow-up, but there were no other differences in QoL parameters examined. After 14 years, diabetes mellitus was present in seven of 15 patients who had the Beger procedure and 11 of 14 patients after ppWhipple resection (P = 0.128). After long-term follow-up of up to 14 years early advantages of the Beger procedure were no longer present. 2007 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.

  18. Antioxidant supplement and long-term reduction of recurrent adenomas of the large bowel. A double-blind randomized trial.

    Science.gov (United States)

    Bonelli, Luigina; Puntoni, Matteo; Gatteschi, Beatrice; Massa, Paolo; Missale, Guido; Munizzi, Francesco; Turbino, Laura; Villanacci, Vincenzo; De Censi, Andrea; Bruzzi, Paolo

    2013-06-01

    Patients who undergo polypectomy are at increased risk of adenoma recurrence. The preventive potential of vitamins (A, C and E) and selenium supplementation represent an interesting opportunity for colorectal cancer prevention. To assess the efficacy of a combination of these micronutrients in reducing the incidence of recurrent adenomas in subjects on post-polypectomy endoscopic follow-up, a double-blind placebo-controlled randomized trial was started in Italy in 1988. A total of 411 patients were randomized to receive either an active compound (200 μg selenium, 30 mg zinc, 2 mg vitamin A, 180 mg vitamin C, 30 mg vitamin E) or a placebo daily for 5 years. Of them, 330 had follow-up colonoscopy (164 in the intervention and 166 in the placebo group). After a median follow-up of 4 years (range 1-15 years), 100 patients had recurrence: 38 in the intervention and 62 in the placebo arm. The 15-year cumulative incidence of recurrence was 48.3% in the intervention and 64.5% in the placebo arm (HR = 0.59; log-rank P = 0.009). A 39% reduction of the risk of recurrence was observed in the intervention compared to the placebo group (adjusted HR = 0.61; 95% CI 0.41-0.92): the risk reduction was similar for small tubular (adjusted HR = 0.61; 95% CI 0.37-0.99) and advanced adenomas (adjusted HR = 0.50; 95% CI 0.24-1.01). Our study showed a statistically significant effect of antioxidant supplementation on adenoma recurrence. Further clinical trials are needed to address the role of antioxidants in subgroups of subjects at increased risk for colorectal cancer.

  19. Tamoxifen for prevention of breast cancer: extended long-term follow-up of the IBIS-I breast cancer prevention trial.

    Science.gov (United States)

    Cuzick, Jack; Sestak, Ivana; Cawthorn, Simon; Hamed, Hisham; Holli, Kaija; Howell, Anthony; Forbes, John F

    2015-01-01

    Four previously published randomised clinical trials have shown that tamoxifen can reduce the risk of breast cancer in healthy women at increased risk of breast cancer in the first 10 years of follow-up. We report the long-term follow-up of the IBIS-I trial, in which the participants and investigators remain largely masked to treatment allocation. In the IBIS-I randomised controlled trial, premenopausal and postmenopausal women 35-70 years of age deemed to be at an increased risk of developing breast cancer were randomly assigned (1:1) to receive oral tamoxifen 20 mg daily or matching placebo for 5 years. Patients were randomly assigned to the two treatment groups by telephone or fax according to a block randomisation schedule (permuted block sizes of six or ten). Patients and investigators were masked to treatment assignment by use of central randomisation and coded drug supply. The primary endpoint was the occurrence of breast cancer (invasive breast cancer and ductal carcinoma in situ), analysed by intention to treat. Cox proportional hazard models were used to assess breast cancer occurrence and mortality. The trial is closed to recruitment and active treatment is completed, but long-term follow-up is ongoing. This trial is registered with controlledtrials.com, number ISRCTN91879928. Between April 14, 1992, and March 30, 2001, 7154 eligible women recruited from genetics clinics and breast care clinics in eight countries were enrolled into the IBIS-I trial and were randomly allocated to the two treatment groups: 3579 to tamoxifen and 3575 to placebo. After a median follow up of 16.0 years (IQR 14.1-17.6), 601 breast cancers have been reported (251 [7.0%] in 3579 patients in the tamoxifen group vs 350 [9.8%] in 3575 women in the placebo group; hazard ratio [HR] 0.71 [95% CI 0.60-0.83], pbreast cancer was similar between years 0-10 (226 [6.3%] in 3575 women in the placebo group vs 163 [4.6%] in 3579 women in the tamoxifen group; hazard ratio [HR] 0.72 [95% CI 0

  20. Parent-mediated social communication therapy for young children with autism (PACT): long-term follow-up of a randomised controlled trial.

    Science.gov (United States)

    Pickles, Andrew; Le Couteur, Ann; Leadbitter, Kathy; Salomone, Erica; Cole-Fletcher, Rachel; Tobin, Hannah; Gammer, Isobel; Lowry, Jessica; Vamvakas, George; Byford, Sarah; Aldred, Catherine; Slonims, Vicky; McConachie, Helen; Howlin, Patricia; Parr, Jeremy R; Charman, Tony; Green, Jonathan

    2016-11-19

    It is not known whether early intervention can improve long-term autism symptom outcomes. We aimed to follow-up the Preschool Autism Communication Trial (PACT), to investigate whether the PACT intervention had a long-term effect on autism symptoms and continued effects on parent and child social interaction. PACT was a randomised controlled trial of a parent-mediated social communication intervention for children aged 2-4 years with core autism. Follow-up ascertainment was done at three specialised clinical services centres in the UK (London, Manchester, and Newcastle) at a median of 5·75 years (IQR 5·42-5·92) from the original trial endpoint. The main blinded outcomes were the comparative severity score (CSS) from the Autism Diagnostic Observation Schedule (ADOS), the Dyadic Communication Assessment Measure (DCMA) of the proportion of child initiatiations when interacting with the parent, and an expressive-receptive language composite. All analyses followed the intention-to-treat principle. PACT is registered with the ISRCTN registry, number ISRCTN58133827. 121 (80%) of the 152 trial participants (59 [77%] of 77 assigned to PACT intervention vs 62 [83%] of 75 assigned to treatment as usual) were traced and consented to be assessed between July, 2013, and September, 2014. Mean age at follow-up was 10·5 years (SD 0·8). Group difference in favour of the PACT intervention based on ADOS CSS of log-odds effect size (ES) was 0·64 (95% CI 0·07 to 1·20) at treatment endpoint and ES 0·70 (95% CI -0·05 to 1·47) at follow-up, giving an overall reduction in symptom severity over the course of the whole trial and follow-up period (ES 0·55, 95% CI 0·14 to 0·91, p=0·004). Group difference in DCMA child initiations at follow-up showed a Cohen's d ES of 0·29 (95% CI -0.02 to 0.57) and was significant over the course of the study (ES 0·33, 95% CI 0·11 to 0·57, p=0·004). There were no group differences in the language composite at follow-up (ES 0·15, 95% CI -0

  1. Long-term effect of exercise therapy in patients with osteoarthritis: a randomized controlled trial comparing two different physiotherapy interventions.

    NARCIS (Netherlands)

    Pisters, M.; Veenhof, C.; Schellevis, F.; Bakker, D. de; Dekker, J.

    2011-01-01

    Purpose: To determine if behavioural graded activity (BGA) results in better long-term effectiveness (5 years after inclusion) than usual exercise therapy (UC; usual care) in patients with OA of the hip or knee. Relevance: The positive effects of exercise therapy in patients with osteoarthritis seem

  2. Long-term effects of a weight loss intervention with or without exercise component in postmenopausal women : A randomized trial

    NARCIS (Netherlands)

    de Roon, Martijn; van Gemert, Willemijn A; Peeters, Petra H; Schuit, A.J.; Monninkhof, Evelyn M

    2017-01-01

    The aim of this study was to determine the long-term effects of a weight loss intervention with or without an exercise component on body weight and physical activity. Women were randomized to diet (n = 97) or exercise (N = 98) for 16 weeks. During the intervention, both groups had achieved the set

  3. Depression treatment after myocardial infarction and long-term risk of subsequent cardiovascular events and mortality: A randomized controlled trial

    NARCIS (Netherlands)

    Zuidersma, M.; Conradi, H.J.; van Melle, J.P.; Ormel, J.; de Jonge, P.

    2013-01-01

    Objective: Evaluating the effects of implementing an antidepressant treatment strategy in depressed myocardial infarction (MI)-patients on long-term cardiovascular outcomes and all-cause mortality. Methods: MI-patients were evaluated for the presence of a diagnosis of post-MI depression at 3, 6, 9

  4. Transference and Countertransference Issues Unique to Long-Term Group Psychotherapy of Adult Women Molested as Children: Trials and Rewards.

    Science.gov (United States)

    Abney, Veronica D.; And Others

    1992-01-01

    Discusses transference and countertransference issues associated with long-term psychodynamic group treatment of adult women molested as children. Describes and examines these women's transference reactions toward group members and the therapist. Also explores the specific effects of race and ethnicity, sexual orientation, and gender of the…

  5. Depression treatment after myocardial infarction and long-term risk of subsequent cardiovascular events and mortality : A randomized controlled trial

    NARCIS (Netherlands)

    Zuidersma, Marij; Conradi, Henk Jan; van Melle, Joost P.; Ormel, Johan; de Jonge, Peter

    Objective: Evaluating the effects of implementing an antidepressant treatment strategy in depressed myocardial infarction (MI)-patients on long-term cardiovascular outcomes and all-cause mortality. Methods: MI-patients were evaluated for the presence of a diagnosis of post-MI depression at 3, 6, 9

  6. FIVE-YEAR OUTCOMES AFTER LONG-TERM OXANDROLONE ADMINISTRATION IN SEVERELY BURNED CHILDREN: A RANDOMIZED CLINICAL TRIAL.

    Science.gov (United States)

    Reeves, Patrick T; Herndon, David N; Tanksley, Jessica D; Jennings, Kristofer; Klein, Gordon L; Mlcak, Ronald P; Clayton, Robert P; Crites, Nancy N; Hays, Joshua P; Andersen, Clark; Lee, Jong O; Meyer, Walter; Suman, Oscar E; Finnerty, Celeste C

    2016-04-01

    Administration of oxandrolone, a nonaromatizable testosterone analog, to children for 12 months following severe burn injury has been shown to improve height, increase bone mineral content (BMC), reduce cardiac work, and augment muscle strength. Surprisingly, the increase in BMC persists well beyond the period of oxandrolone administration. This study was undertaken to determine if administration of oxandrolone for 2 years yields greater effects on long-term BMC and bone mineral density (BMD). Patients between 0 and 18 years of age with ≥30% of total body surface area burned were consented to an IRB-approved protocol and randomized to receive either placebo (n = 84) or 0.1 mg/kg oxandrolone orally twice daily for 24 months (n = 35). Patients were followed prospectively from the time of admission until 5 years postburn in a single-center, intent-to-treat setting. Height, weight, BMC, and BMD were recorded annually through 5 years postinjury. The long-term administration of oxandrolone for 16 ± 1 months postburn (range, 12.1-25.2 months) significantly increased whole-body (WB) BMC (p patients who were in growth spurt years (7-18 years). When adjusted for height, sex, and age, LS BMD was found to significantly increase with long-term oxandrolone administration (p patients receiving oxandrolone exhibited LS BMD z scores below -2.0 as compared with controls, indicating a significantly reduced risk for future fracture with oxandrolone administration. Long-term oxandrolone patients had significantly greater height velocity than controls throughout the first 2-year postburn (p patients receiving long-term oxandrolone to previously described patients receiving 12 months of oxandrolone revealed that long-term oxandrolone administration imparted significantly greater increases in WB-BMC, WB-BMD, and LS-BMD (p burned pediatric patients significantly improves WB BMC, LS BMC, LS BMD, and height velocity. The administration of long-term oxandrolone was more efficacious than

  7. Effect of a participatory organizational-level occupational health intervention on short-term sickness absence: a cluster randomized controlled trial.

    Science.gov (United States)

    Framke, Elisabeth; Sørensen, Ole Henning; Pedersen, Jacob; Rugulies, Reiner

    2016-05-01

    The aim of this study was to examine whether employees in pre-schools that implemented a participatory organizational-level intervention focusing on the core task at work had a lower incidence of short-term sickness absence compared to employees in the control group. The cluster randomized controlled trial (RCT) comprised 78 pre-schools that were allocated to the intervention (44 pre-schools with 1760 employees) or control (34 pre-schools with 1279 employees) group. The intervention lasted 25 months and followed a stepwise and structured approach, consisting of seminars, workshops, and workplace-directed intervention activities focusing on the core task at work. Using Poisson regression, we tested differences in incidence rates in short-term sickness absence between the intervention and control groups during a 29-months follow-up. Estimated short-term sickness absence days per person-year during follow-up were 8.68 and 9.17 in the intervention and control groups, respectively. The rate ratio (RR) for comparing incident sickness absence in the intervention to control groups during follow-up was 0.93 [95% confidence interval (95% CI) 0.86-1.00] in the crude analysis and 0.89 (95% CI 0.83-0.96) when adjusting for age, sex, job group, type and size of workplace, and workplace average level of previous short-term sickness absence. A supplementary analysis showed that the intervention also was associated with a reduced risk of long-term sickness absence with a crude RR of 0.83 (95% CI 0.69-0.99) and an adjusted RR of 0.84 (95% CI 0.69-1.01). Pre-school employees participating in an organizational-level occupational health intervention focusing on the core task at work had a lower incidence of short-term sickness absence during a 29-month follow-up compared with control group employees.

  8. Long-Term Impact of Endometrial Cancer Diagnosis and Treatment on Health-Related Quality of Life and Cancer Survivorship: Results From the Randomized PORTEC-2 Trial

    International Nuclear Information System (INIS)

    Boer, Stephanie M. de; Nout, Remi A.; Jürgenliemk-Schulz, Ina M.; Jobsen, Jan J.; Lutgens, Ludy C.H.W.; Steen-Banasik, Elzbieta M. van der; Mens, Jan Willem M.; Slot, Annerie; Stenfert Kroese, Marika C.; Oerlemans, Simone; Putter, Hein; Verhoeven-Adema, Karen W.; Nijman, Hans W.; Creutzberg, Carien L.

    2015-01-01

    Purpose: To evaluate the long-term health-related quality of life (HRQL) after external beam radiation therapy (EBRT) or vaginal brachytherapy (VBT) among PORTEC-2 trial patients, evaluate long-term bowel and bladder symptoms, and assess the impact of cancer on these endometrial cancer (EC) survivors. Patients and Methods: In the PORTEC-2 trial, 427 patients with stage I high–intermediate-risk EC were randomly allocated to EBRT or VBT. The 7- and 10-year HRQL questionnaires consisted of EORTC QLQ-C30; subscales for bowel and bladder symptoms; the Impact of Cancer Questionnaire; and 14 questions on comorbidities, walking aids, and incontinence pads. Analysis was done using linear mixed models for subscales and (ordinal) logistic regression with random effects for single items. A two-sided P value <.01 was considered statistically significant. Results: Longitudinal HRQL analysis showed persisting higher rates of bowel symptoms with EBRT, without significant differences in global health or any of the functioning scales. At 7 years, clinically relevant fecal leakage was reported by 10.6% in the EBRT group, versus 1.8% for VBT (P=.03), diarrhea by 8.4% versus 0.9% (P=.04), limitations due to bowel symptoms by 10.5% versus 1.8% (P=.001), and bowel urgency by 23.3% versus 6.6% (P<.001). Urinary urgency was reported by 39.3% of EBRT patients, 25.5% for VBT, P=.05. No difference in sexual activity was seen between treatment arms. Long-term impact of cancer scores was higher among the patients who had an EC recurrence or second cancer. Conclusions: More than 7 years after treatment, EBRT patients reported more bowel symptoms with impact on daily activities, and a trend for more urinary symptoms, without impact on overall quality of life or difference in cancer survivorship issues.

  9. Long-Term Impact of Endometrial Cancer Diagnosis and Treatment on Health-Related Quality of Life and Cancer Survivorship: Results From the Randomized PORTEC-2 Trial

    Energy Technology Data Exchange (ETDEWEB)

    Boer, Stephanie M. de, E-mail: s.m.de_boer.ONCO@lumc.nl [Department of Radiation Oncology, Leiden University Medical Center, Leiden (Netherlands); Nout, Remi A. [Department of Radiation Oncology, Leiden University Medical Center, Leiden (Netherlands); Jürgenliemk-Schulz, Ina M. [Department of Radiation Oncology, University Medical Center Utrecht, Utrecht (Netherlands); Jobsen, Jan J. [Department of Radiotherapy, Medisch Spectrum Twente, Enschede (Netherlands); Lutgens, Ludy C.H.W. [Department of Radiation Oncology (MAASTRO), University Medical Centre Maastricht (Netherlands); Steen-Banasik, Elzbieta M. van der [Arnhem Radiotherapy Institute (ARTI), Arnhem (Netherlands); Mens, Jan Willem M. [Department of Radiation Oncology, Erasmus MC-Daniel den Hoed Cancer Center, Rotterdam (Netherlands); Slot, Annerie [Radiotherapy Institute Friesland, Leeuwarden (Netherlands); Stenfert Kroese, Marika C. [Department of Radiation Oncology, Radiotherapy Group Deventer, Deventer (Netherlands); Oerlemans, Simone [Research Department, Netherlands Comprehensive Cancer Organization, Eindhoven (Netherlands); Center of Research on Psychology in Somatic Diseases, Tilburg University, Tilburg (Netherlands); Putter, Hein [Department of Medical Statistics, Leiden University Medical Center, Leiden (Netherlands); Verhoeven-Adema, Karen W. [Comprehensive Cancer Center The Netherlands-West, Leiden (Netherlands); Nijman, Hans W. [Department of Gynecologic Oncology, University Medical Center Groningen, Groningen (Netherlands); Creutzberg, Carien L. [Department of Radiation Oncology, Leiden University Medical Center, Leiden (Netherlands)

    2015-11-15

    Purpose: To evaluate the long-term health-related quality of life (HRQL) after external beam radiation therapy (EBRT) or vaginal brachytherapy (VBT) among PORTEC-2 trial patients, evaluate long-term bowel and bladder symptoms, and assess the impact of cancer on these endometrial cancer (EC) survivors. Patients and Methods: In the PORTEC-2 trial, 427 patients with stage I high–intermediate-risk EC were randomly allocated to EBRT or VBT. The 7- and 10-year HRQL questionnaires consisted of EORTC QLQ-C30; subscales for bowel and bladder symptoms; the Impact of Cancer Questionnaire; and 14 questions on comorbidities, walking aids, and incontinence pads. Analysis was done using linear mixed models for subscales and (ordinal) logistic regression with random effects for single items. A two-sided P value <.01 was considered statistically significant. Results: Longitudinal HRQL analysis showed persisting higher rates of bowel symptoms with EBRT, without significant differences in global health or any of the functioning scales. At 7 years, clinically relevant fecal leakage was reported by 10.6% in the EBRT group, versus 1.8% for VBT (P=.03), diarrhea by 8.4% versus 0.9% (P=.04), limitations due to bowel symptoms by 10.5% versus 1.8% (P=.001), and bowel urgency by 23.3% versus 6.6% (P<.001). Urinary urgency was reported by 39.3% of EBRT patients, 25.5% for VBT, P=.05. No difference in sexual activity was seen between treatment arms. Long-term impact of cancer scores was higher among the patients who had an EC recurrence or second cancer. Conclusions: More than 7 years after treatment, EBRT patients reported more bowel symptoms with impact on daily activities, and a trend for more urinary symptoms, without impact on overall quality of life or difference in cancer survivorship issues.

  10. Adjuvant radiation therapy versus surgery alone in operable breast cancer: long-term follow-up of a randomized clinical trial.

    Science.gov (United States)

    Rutqvist, L E; Pettersson, D; Johansson, H

    1993-02-01

    This paper presents long-term results from a randomized trial of pre- or postoperative megavoltage radiation therapy versus surgery alone in pre- and postmenopausal women with operable breast cancer. Treatment outcome after relapse among patients who developed loco-regional recurrences was also analyzed. A total of 960 patients were included in the trial. The mean follow-up was 16 years (range: 13-19 years). The radiation therapy was individually planned. It included the chest wall (and the breast in the preoperative cases) and the regional lymph nodes. The tumor dose was 45 Gy/5 weeks. No adjuvant systemic therapy was used. The results showed a significant benefit with radiation therapy in terms of recurrence-free survival during the entire follow-up period. There was also an overall survival difference-corresponding to a 16% reduction of deaths-in favor of the irradiated patients which, however, was not statistically significant (p = 0.09). Among those 169 patients who developed locoregional recurrences long-term control was only achieved in about one-third of the cases. This figure was similar among those who had received adjuvant radiation therapy (34%) compared to those initially treated with surgery alone (32%). This implied that the overall proportion of patients who eventually developed uncontrolled local disease was significantly higher among those initially allocated to surgery alone (16%) compared to those allocated to pre- or postoperative radiation therapy (6%, p < 0.01). These results suggest that local undertreatment may be deleterious in subgroups of patients.

  11. Referral from primary care to a physical activity programme: establishing long-term adherence? A randomized controlled trial. Rationale and study design

    Directory of Open Access Journals (Sweden)

    Puig-Ribera Anna

    2009-01-01

    . Discussion The pilot study showed the effectiveness of an enhanced low-cost, evidence-based intervention in increased physical activity and improved social support. If successful in demonstrating long-term improvements, this randomised controlled trial will be the first sustainable physical activity intervention based in primary care in our country to demonstrate long-term adherence to physical activity. Trial Registration A service of the U.S. National Institutes of Health. Developed by the National Library of Medicine. ClinicalTrials.gov ID: NCT00714831.

  12. A randomized controlled trial of tai chi for long-term low back pain (TAI CHI: Study rationale, design, and methods

    Directory of Open Access Journals (Sweden)

    Hall Amanda M

    2009-05-01

    Full Text Available Abstract Background Low back pain persisting for longer than 3 months is a common and costly condition for which many current treatments have low-moderate success rates at best. Exercise is among the more successful treatments for this condition, however, the type and dosage of exercise that elicits the best results is not clearly defined. Tai chi is a gentle form of low intensity exercise that uses controlled movements in combination with relaxation techniques and is currently used as a safe form of exercise for people suffering from other chronic pain conditions such as arthritis. To date, there has been no scientific evaluation of tai chi as an intervention for people with back pain. Thus the aim of this study will be to examine the effects of a tai chi exercise program on pain and disability in people with long-term low back pain. Methods and design The study will recruit 160 healthy individuals from the community setting to be randomised to either a tai chi intervention group or a wait-list control group. Individuals in the tai chi group will attend 2 tai chi sessions (40 minutes/week for 8 weeks followed by 1 tai chi session/week for 2 weeks. The wait-list control will continue their usual health care practices and have the opportunity to participate in the tai chi program once they have completed the follow-up assessments. The primary outcome will be bothersomeness of back symptoms measured with a 0–10 numerical rating scale. Secondary outcomes include, self-reports of pain-related disability, health-related quality of life and global perceived effect of treatment. Statistical analysis of primary and secondary outcomes will be based on the intention to treat principle. Linear mixed models will be used to test for the effect of treatment on outcome at 10 weeks follow up. This trial has received ethics approval from The University of Sydney Human Research Ethics Committee. HREC Approval No.10452 Discussion This study will be the first

  13. Short-term effectiveness of web-based guided self-help for phobic outpatients: randomized controlled trial.

    Science.gov (United States)

    Kok, Robin N; van Straten, Annemieke; Beekman, Aartjan T F; Cuijpers, Pim

    2014-09-29

    Internet-based guided self-help has been successfully used in the general population, but it is unknown whether this method can be effectively used in outpatient clinics for patients waiting for face-to-face psychotherapy for phobias. The aim was to assess the clinical effectiveness of Phobias Under Control, an Internet-based intervention based on exposure therapy with weekly guidance. We conducted a randomized controlled trial, recruiting 212 outpatients scheduled to receive face-to-face psychotherapy for any type of phobia at an outpatient clinic. Participants suffering from at least 1 DSM-IV or ICD-10 classified phobia (social phobia, agoraphobia with or without panic disorder, and/or specific phobia as ascertained by a telephone interview at baseline) were randomly allocated to either a 5-week Internet-based guided self-help program based on exposure therapy with weekly student support followed by face-to-face psychotherapy (n=105) or a wait-list control group followed by face-to-face psychotherapy (n=107). Primary outcome was the Fear Questionnaire (FQ). Secondary outcomes were the Beck Anxiety Inventory (BAI) and Center of Epidemiological Studies-Depression scale (CES-D). Assessments took place by telephone at baseline (T0) and on the Internet at posttest (T1, self-assessment at 5 weeks after baseline). Missing data at T1 were imputed. At posttest, analysis of covariance on the intention-to-treat sample showed significant but small effect sizes between intervention and control groups on the FQ (d=0.35, P=.02), CES-D (d=0.34, P=.03), and a nonsignificant effect size on the BAI (d=0.28. P=.05). Although initial acceptance was good, high nonresponse was observed, with 86 of 212 participants (40.5%) lost to follow-up at T1 and only 14 of 105 (13.3%) intervention participants finishing all 5 weeks. Phobias Under Control is modestly effective in lowering phobic and depressive symptoms in a relatively short period and may be clinically beneficial when implemented in

  14. FIVE-YEAR OUTCOMES AFTER LONG-TERM OXANDROLONE ADMINISTRATION IN SEVERELY BURNED CHILDREN: A RANDOMIZED CLINICAL TRIAL

    OpenAIRE

    Reeves, Patrick T; Herndon, David N; Tanksley, Jessica D; Jennings, Kristofer; Klein, Gordon L; Mlcak, Ronald P; Clayton, Robert P; Crites, Nancy N; Hays, Joshua P; Andersen, Clark; Lee, Jong O; Meyer, Walter; Suman, Oscar E; Finnerty, Celeste C

    2016-01-01

    Administration of oxandrolone, a non-aromatizable testosterone analog, to children for 12 months following severe burn injury has been shown to improve height, increase bone mineral content (BMC), reduce cardiac work, and augment muscle strength. Surprisingly, the increase in BMC persists well beyond the period of oxandrolone administration. This study was undertaken to determine if administration of oxandrolone for 2 years yields greater effects on long-term BMC and bone mineral density (BMD...

  15. Protocol for the immediate delivery versus expectant care of women with preterm prelabour rupture of the membranes close to term (PPROMT Trial [ISRCTN44485060

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    Buchanan Sarah L

    2006-03-01

    Full Text Available Abstract Background Preterm prelabour rupture of membranes (PPROM complicates up to 2% of all pregnancies and is the cause of 40% of all preterm births. The optimal management of women with PPROM prior to 37 weeks, is not known. Furthermore, diversity in current clinical practice suggests uncertainty about the appropriate clinical management. There are two options for managing PPROM, expectant management (a wait and see approach or early planned birth. Infection is the main risk for women in which management is expectant. This risk need to be balanced against the risk of iatrogenic prematurity if early delivery is planned. The different treatment options may also have different health care costs. Expectant management results in prolonged antenatal hospitalisation while planned early delivery may necessitate intensive care of the neonate for problems associated with prematurity. Methods/Design We aim to evaluate the effectiveness of early planned birth compared with expectant management for women with PPROM between 34 weeks and 366 weeks gestation, in a randomised controlled trial. A secondary aim is a cost analysis to establish the economic impact of the two treatment options and establish the treatment preferences of women with PPROM close to term. The early planned birth group will be delivered within 24 hours according to local management protocols. In the expectant management group birth will occur after spontaneous labour, at term or when the attending clinician feels that birth is indicated according to usual care. Approximately 1812 women with PPROM at 34–366 weeks gestation will be recruited for the trial. The primary outcome of the study is neonatal sepsis. Secondary infant outcomes include respiratory distress, perinatal mortality, neonatal intensive care unit admission, assisted ventilation and early infant development. Secondary maternal outcomes include chorioamnionitis, postpartum infection treated with antibiotics, antepartum

  16. The long-term effects of naprapathic manual therapy on back and neck pain - Results from a pragmatic randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Bohman Tony

    2010-02-01

    Full Text Available Abstract Background Back and neck pain are very common, disabling and recurrent disorders in the general population and the knowledge of long-term effect of treatments are sparse. The aim of this study was to compare the long-term effects (up to one year of naprapathic manual therapy and evidence-based advice on staying active regarding non-specific back and/or neck pain. Naprapathy, a health profession mainly practiced in Sweden, Finland, Norway and in the USA, is characterized by a combination of manual musculoskeletal manipulations, aiming to decrease pain and disability in the neuromusculoskeletal system. Methods Subjects with non-specific pain/disability in the back and/or neck lasting for at least two weeks (n = 409, recruited at public companies in Sweden, were included in this pragmatic randomized controlled trial. The two interventions compared were naprapathic manual therapy such as spinal manipulation/mobilization, massage and stretching, (Index Group, and advice to stay active and on how to cope with pain, provided by a physician (Control Group. Pain intensity, disability and health status were measured by questionnaires. Results 89% completed the 26-week follow-up and 85% the 52-week follow-up. A higher proportion in the Index Group had a clinically important decrease in pain (risk difference (RD = 21%, 95% CI: 10-30 and disability (RD = 11%, 95% CI: 4-22 at 26-week, as well as at 52-week follow-ups (pain: RD = 17%, 95% CI: 7-27 and disability: RD = 17%, 95% CI: 5-28. The differences between the groups in pain and disability considered over one year were statistically significant favoring naprapathy (p ≤ 0.005. There were also significant differences in improvement in bodily pain and social function (subscales of SF-36 health status favoring the Index Group. Conclusions Combined manual therapy, like naprapathy, is effective in the short and in the long term, and might be considered for patients with non-specific back and/or neck

  17. Remifentanil versus placebo for analgesia during external cephalic version: a randomised clinical trial.

    Science.gov (United States)

    Muñoz, H; Guerra, S; Perez-Vaquero, P; Valero Martinez, C; Aizpuru, F; Lopez-Picado, A

    2014-02-01

    Breech presentation occurs in up to 3% of pregnancies at term and may be an indication for caesarean delivery. External cephalic version can be effective in repositioning the fetus in a cephalic presentation, but may be painful for the mother. Our aim was to assess the efficacy of remifentanil versus placebo for pain relief during external cephalic version. A randomized, double-blind, controlled trial that included women at 36-41 weeks of gestation with non-cephalic presentations was performed. Women were randomized to receive either a remifentanil infusion at 0.1 μg/kg/min and demand boluses of 0.1 μg/kg, or saline placebo. The primary outcome was the numerical rating pain score (0-10) after external cephalic version. Sixty women were recruited, 29 in the control group and 31 in the remifentanil group. There were significant differences in pain scores at the end of the procedure (control 6.5 ± 2.4 vs. remifentanil 4.7 ± 2.5, P = 0.005) but not 10 min later (P = 0.054). The overall success rate for external cephalic version was 49% with no significant differences between groups (remifentanil group 54.8% vs. control group 41.3%, P = 0.358). In the remifentanil group, there was one case of nausea and vomiting, one of drowsiness and three cases of fetal bradycardia. In the control group, there were three cases of nausea and vomiting, one of dizziness and nine cases of fetal bradycardia. Intravenous remifentanil with bolus doses on demand during external cephalic version achieved a reduction in pain and increased maternal satisfaction. There were no additional adverse effects, and no difference in the success rate of external cephalic version or the incidence of fetal bradycardia. Copyright © 2013 Elsevier Ltd. All rights reserved.

  18. Randomized controlled clinical trial of long-term chemo-mechanical caries removal using PapacarieTM gel

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    Lara Jansiski MOTTA

    2014-07-01

    Full Text Available Objectives: Compare the effectiveness of PapacarieTM gel for the chemo-mechanical removal of carious lesions on primary teeth to conventional caries removal with a low-speed bur with regard to execution time, clinical aspects and radiographic findings. Material and Methods: A randomized controlled clinical trial with a split-mouth design was carried out. The sample was composed of 20 children aged four to seven years, in whom 40 deciduous teeth were randomly divided into two groups: chemo-mechanical caries removal with PapacarieTM and removal of carious dentin with a low-speed bur. Each child underwent both procedures and served as his/her own control. Restorations were performed with glass ionomer cement. The time required to perform the procedure was also analyzed. The patients underwent longitudinal clinical and radiographic follow-up of the restorations. Results: No statistically significant difference between groups was found regarding the time required to perform the procedures and the radiographic follow up. Statistically significant differences between groups were found in the clinical evaluation at 6 and 18 months after treatment. Conclusion: PapacarieTM is as effective as the traditional method for the removal of carious dentin on deciduous teeth, but offers the advantages of the preservation of sound dental tissue as well as the avoidance of sharp rotary instruments and local anesthesia.

  19. Long-Term Effects of Goshajinkigan in Prevention of Diabetic Complications: A Randomized Open-Labeled Clinical Trial

    Directory of Open Access Journals (Sweden)

    K. Watanabe

    2014-01-01

    Full Text Available Objective. This clinical trial was designed to investigate whether goshajinkigan reduces the onset of diabetic complications or not. Materials and Methods. A total of 332 type 2 diabetic mellitus patients were registered from 9 clinical centers from March 2000 to August 2007. Patients were randomly assigned to take goshajinkigan extract powder, 2.5 grams for 3 times a day or no kampo therapy, additionally to the regular treatment. The primary endpoints were the onset of macrovascular diseases or progression of nephropathy or retinopathy. Statistical analysis was performed by the intention-to-treat method. Results. After 5 years of observation, 116 patients were submitted to analysis. Among them, no macrovascular events were observed in both groups. Although 43 participants had upstaging of retinopathy or nephropathy in total, there was no significant difference between goshajinkigan group and control group. Deterioration of ankle reflex was suppressed in goshajinkigan group. Also glycated hemoglobin, and fasting plasma glucose were decreased in the goshajinkigan group. Conclusion. Although the power of analysis was too low to demonstrate any effects of goshajinkigan on the progression of macrovascular diseases, retinopathy or nephropathy, goshajinkigan may be beneficial for diabetic neuropathy and glycemic control.

  20. Effects of modafinil on attention performance, short-term memory and executive function in university students: a randomized trial.

    Science.gov (United States)

    Fernández, Alejandro; Mascayano, Franco; Lips, Walter; Painel, Andrés; Norambuena, Jonathan; Madrid, Eva

    2015-06-30

    Modafinil is a drug developed and used for the treatment of excessive lethargy. Even though very effective for sleep disorders, it is still controversial whether modafinil can improve performance in high-order cognitive processes such as memory and executive function. This randomized, double-blind, placebo-controlled, crossover trial was designed to evaluate the effect of modafinil (compared to placebo) on the cognitive functions of healthy students. 160 volunteers were recruited and allocated randomly to modafinil or placebo group, and were assessed using the Stroop Test, BCET test and Digit span test. We found a significant difference in favor of modafinil compared to placebo in the proportion of correct answers of Stroop Test in congruent situation. A significant shorter latency of modafinil group in the incongruent situation of Stroop test was also found. No differences were found in Digit Span, or BCET tests. The study demonstrated that modafinil does not enhance the global cognitive performance of healthy non-sleep deprived students, except regarding non-demanding tasks. In particular, this drug does not seem to have positive effects on mental processes that sustain studying tasks in the college population under normal conditions. We expect these findings to demystify the use of this drug and help decision making concerning pharmacological public policies.

  1. No difference in terms of radiostereometric analysis between fixed- and mobile-bearing total knee arthroplasty: a randomized, single-blind, controlled trial.

    Science.gov (United States)

    Schotanus, M G M; Pilot, P; Kaptein, B L; Draijer, W F; Tilman, P B J; Vos, R; Kort, N P

    2017-09-01

    A concern that arises with any new prosthesis is whether it will achieve satisfactory long-term implant stability. The gold standard of assessing the quality of fixation in a new or relatively new implant is to undertake a randomized controlled trial using radiostereometric analysis. It was hypothesized that both mobile-bearing total knee arthroplasty and fixed-bearing total knee arthroplasty have comparable migration patterns at 2-year follow-up. This study investigated two types of cemented total knee arthroplasty, the mobile- or fixed-bearing variant from the same family with use of radiostereometric analysis. This prospective, patient-blinded, randomized, controlled trial was designed to investigate early migration of the tibia component after two years of follow-up with use of radiostereometric analysis. A total of 50 patients were randomized to receive a mobile- or fixed-bearing TKA from the same family. Patients were evaluated during 2-year follow-up, including radiostereometric analysis, physical and clinical examination and patient reported outcome measures (PROMs). At two-year follow-up, the mean (±SD) maximum total point motion (MTPM) in the fixed-bearing group was 0.82 (±1.16) versus 0.92 mm (±0.64) in the mobile-bearing group (p = n.s) with the largest migration seen during the first 6 weeks (0.45 ± 0.32 vs. 0.54 ± 0.30). The clinical outcome and PROMs significantly improved within each group, not between both groups. Measuring early micromotion is useful for predicting clinical loosening that can lead to revision. The results of this study demonstrate that early migration of the mobile-bearing is similar to that of the fixed-bearing component at two years and was mainly seen in the first weeks after implantation. Randomized, single-blind, controlled trial, Level I.

  2. Effectiveness of psychological interventions to improve quality of life in people with long-term conditions: rapid systematic review of randomised controlled trials.

    Science.gov (United States)

    Anderson, Niall; Ozakinci, Gozde

    2018-03-27

    Long-term conditions may negatively impact multiple aspects of quality of life including physical functioning and mental wellbeing. The rapid systematic review aimed to examine the effectiveness of psychological interventions to improve quality of life in people with long-term conditions to inform future healthcare provision and research. EBSCOhost and OVID were used to search four databases (PsychInfo, PBSC, Medline and Embase). Relevant papers were systematically extracted by one researcher using the predefined inclusion/exclusion criteria based on titles, abstracts, and full texts. Randomized controlled trial psychological interventions conducted between 2006 and February 2016 to directly target and assess people with long-term conditions in order to improve quality of life were included. Interventions without long-term condition populations, psychological intervention and/or patient-assessed quality of life were excluded. From 2223 citations identified, 6 satisfied the inclusion/exclusion criteria. All 6 studies significantly improved at least one quality of life outcome immediately post-intervention. Significant quality of life improvements were maintained at 12-months follow-up in one out of two studies for each of the short- (0-3 months), medium- (3-12 months), and long-term (≥ 12 months) study duration categories. All 6 psychological intervention studies significantly improved at least one quality of life outcome immediately post-intervention, with three out of six studies maintaining effects up to 12-months post-intervention. Future studies should seek to assess the efficacy of tailored psychological interventions using different formats, durations and facilitators to supplement healthcare provision and practice.

  3. Long-term follow-up of a randomized trial of family foundations: effects on children's emotional, behavioral, and school adjustment.

    Science.gov (United States)

    Feinberg, Mark E; Jones, Damon E; Roettger, Michael E; Solmeyer, Anna; Hostetler, Michelle L

    2014-12-01

    This study examines long-term effects of a transition to parenthood program, Family Foundations, designed to enhance child outcomes through a strategic focus on supporting the coparenting relationship. Roughly 5 to 7 years after baseline (pregnancy), parent and teacher reports of internalizing and externalizing problems and school adjustment were collected by mail for 98 children born to couples enrolled in the randomized trial. Teachers reported significantly lower levels of internalizing problems among children in the intervention group compared with children in the control group and, consistent with prior findings at age 3, lower levels of externalizing problems for boys in the intervention group. Baseline level of observed couple negative communication moderated intervention effects for parent and teacher report of child adjustment and teacher report of school adjustment and adaptation. Effect sizes ranged from 0.40 to 0.98. Results indicate that relatively brief preventive programs for couples at the transition to parenthood have the capacity to promote long-term positive benefits for children's adjustment. Although we attended to missing data issues in several ways, high levels of attrition in this long-term follow-up study is a cause for caution.

  4. Immediate and Short-Term Effects of Upper Thoracic Manipulation on Myoelectric Activity of Sternocleidomastoid Muscles in Young Women With Chronic Neck Pain: A Randomized Blind Clinical Trial.

    Science.gov (United States)

    Pires, Paulo Fernandes; Packer, Amanda Carine; Dibai-Filho, Almir Vieira; Rodrigues-Bigaton, Delaine

    2015-10-01

    The aim of this study was to assess the immediate and short-term effects of upper thoracic spine manipulation on pain intensity and myoelectric activity of the sternocleidomastoid muscles in young women with chronic neck pain. A randomized clinical trial was carried out involving 32 women with chronic neck pain (mean age, 24.8 ± 5.4 years) allocated to an experimental group and a placebo group. Three evaluations were carried out: baseline, immediate postintervention, and short-term postintervention (48-72 hours after intervention). Myoelectric activity of the right and left sternocleidomastoid muscles was assessed at rest and during isometric contractions for cervical flexion and elevation of the shoulder girdle. Neck pain intensity was assessed at rest using a visual analog scale. Comparisons of the data were performed using 2-way repeated-measures analysis of variance with the Bonferroni correction. The level of significance was set at P 0.40). No statistically significant differences were found for any of the variables analyzed in the intergroup comparisons at the different evaluation times (P > .05). No statistically significant differences were found in the intragroup or intergroup analyses of the experimental and placebo groups regarding myoelectric activity of the cervical muscles or the intensity of neck pain at rest in the immediate or short-term postintervention evaluations. Copyright © 2015 National University of Health Sciences. Published by Elsevier Inc. All rights reserved.

  5. Long-term Impact of Weight Loss Intervention on Changes in Cognitive Function: Exploratory Analyses from the Action for Health in Diabetes Randomized Controlled Clinical Trial.

    Science.gov (United States)

    Espeland, Mark A; Carmichael, Owen; Hayden, Kathleen; Neiberg, Rebecca H; Newman, Anne B; Keller, Jeffery N; Wadden, Thomas A; Rapp, Stephen R; Hill, James O; Horton, Edward S; Johnson, Karen C; Wagenknecht, Lynne; Wing, Rena R

    2018-03-14

    Diabetes adversely impacts cognition. Lifestyle change can improve diabetes control and potentially improve cognition. We examined whether weight loss through reduced caloric intake and increased physical activity was associated with slower cognitive aging in older adults with type 2 diabetes mellitus. The Look AHEAD randomized controlled clinical trial delivered 10 years of intensive lifestyle intervention (ILI) that yielded long-term weight losses. During 5 years spanning the end of intervention and postintervention follow-up, repeated cognitive assessments were obtained in 1,091 individuals who had been assigned to ILI or a control condition of diabetes support and education (DSE). We compared the means and slopes of scores on cognitive testing over these repeated assessments. Compared with DSE, assignment to ILI was associated with a -0.082 SD deficit in mean global cognitive function across repeated assessments (p = .010). However, overweight (body mass index [BMI] memory. The behavioral weight loss intervention was associated with small relative deficits in cognitive function among individuals who were obese and marginally greater cognitive decline overall compared to control. ClinicalTrials.gov Identifier: NCT00017953.

  6. The Aged Residential Care Healthcare Utilization Study (ARCHUS): a multidisciplinary, cluster randomized controlled trial designed to reduce acute avoidable hospitalizations from long-term care facilities.

    Science.gov (United States)

    Connolly, Martin J; Boyd, Michal; Broad, Joanna B; Kerse, Ngaire; Lumley, Thomas; Whitehead, Noeline; Foster, Susan

    2015-01-01

    To assess effect of a complex, multidisciplinary intervention aimed at reducing avoidable acute hospitalization of residents of residential aged care (RAC) facilities. Cluster randomized controlled trial. RAC facilities with higher than expected hospitalizations in Auckland, New Zealand, were recruited and randomized to intervention or control. A total of 1998 residents of 18 intervention facilities and 18 control facilities. A facility-based complex intervention of 9 months' duration. The intervention comprised gerontology nurse specialist (GNS)-led staff education, facility bench-marking, GNS resident review, and multidisciplinary (geriatrician, primary-care physician, pharmacist, GNS, and facility nurse) discussion of residents selected using standard criteria. Primary end point was avoidable hospitalizations. Secondary end points were all acute admissions, mortality, and acute bed-days. Follow-up was for a total of 14 months. The intervention did not affect main study end points: number of acute avoidable hospital admissions (RR 1.07; 95% CI 0.85-1.36; P = .59) or mortality (RR 1.11; 95% CI 0.76-1.61; P = .62). This multidisciplinary intervention, packaging selected case review, and staff education had no overall impact on acute hospital admissions or mortality. This may have considerable implications for resourcing in the acute and RAC sectors in the face of population aging. Australian and New Zealand Clinical Trials Registry (ACTRN12611000187943). Copyright © 2015 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

  7. Proof of Learning Outcome by the Advanced Clinical Competency Examination Trial after the Long-term Student's Practice in Pharmaceutical Education.

    Science.gov (United States)

    Komori, Koji; Kataoka, Makoto; Kuramoto, Nobuyuki; Tsuji, Takumi; Nakatani, Takafumi; Yasuhara, Tomohisa; Mitamura, Shinobu; Hane, Yumiko; Ogita, Kiyokazu

    2016-01-01

    At Setsunan University, a debrief session (a poster session) is commonly performed by the students who have completed the long-term students' practice. Since the valuable changes in practical competency of the students cannot be evaluated through this session, we specified items that can help evaluate and methods that can help estimate the students' competency as clinical pharmacists. We subsequently carried out a trial called the "Advanced Clinical Competency Examination". We evaluated 103 students who had concluded the students' practice for the second period (Sep 1, 2014, to Nov 16, 2014): 70 students (called "All finish students") who had completed the practice in a hospital and pharmacy, and 33 students (called "Hospital finish students") who had finished the practice at a hospital only. The trial was executed in four stages. In the first stage, students drew pictures of something impressive they had learned during the practice. In the second stage, students were given patient cases and were asked, "What is this patient's problem?" and "How would you solve this problem?". In the third stage, the students discussed their answers in a group. In the fourth stage, each group made a poster presentation in separate rooms. By using a rubric, the teachers evaluated each student individually, the results of which showed that the "All finish students" could identify more problems than the "Hospital finish students".

  8. Short-term soy isoflavone intervention in patients with localized prostate cancer: a randomized, double-blind, placebo-controlled trial.

    Directory of Open Access Journals (Sweden)

    Jill M Hamilton-Reeves

    Full Text Available We describe the effects of soy isoflavone consumption on prostate specific antigen (PSA, hormone levels, total cholesterol, and apoptosis in men with localized prostate cancer.We conducted a double-blinded, randomized, placebo-controlled trial to examine the effect of soy isoflavone capsules (80 mg/d of total isoflavones, 51 mg/d aglucon units on serum and tissue biomarkers in patients with localized prostate cancer. Eighty-six men were randomized to treatment with isoflavones (n=42 or placebo (n=44 for up to six weeks prior to scheduled prostatectomy. We performed microarray analysis using a targeted cell cycle regulation and apoptosis gene chip (GEArrayTM. Changes in serum total testosterone, free testosterone, total estrogen, estradiol, PSA, and total cholesterol were analyzed at baseline, mid-point, and at the time of radical prostatectomy. In this preliminary analysis, 12 genes involved in cell cycle control and 9 genes involved in apoptosis were down-regulated in the treatment tumor tissues versus the placebo control. Changes in serum total testosterone, free testosterone, total estrogen, estradiol, PSA, and total cholesterol in the isoflavone-treated group compared to men receiving placebo were not statistically significant.These data suggest that short-term intake of soy isoflavones did not affect serum hormone levels, total cholesterol, or PSA.ClinicalTrials.gov NCT00255125.

  9. Empowering Parents of Obese Children (EPOC): A randomized controlled trial on additional long-term weight effects of parent training.

    Science.gov (United States)

    Warschburger, Petra; Kroeller, Katja; Haerting, Johannes; Unverzagt, Susanne; van Egmond-Fröhlich, Andreas

    2016-08-01

    Although inpatient lifestyle treatment for obese children and adolescents can be highly effective in the short term, long-term results are unconvincing. One possible explanation might be that the treatment takes place far from parents' homes, limiting the possibility to incorporate the parents, who play a major role in establishing and maintaining a healthy lifestyle in childhood and adolescence. The main goal was to develop a brief behaviorally oriented parent training program that enhances 'obesity-specific' parenting skills in order to prevent relapse. We hypothesized that the inclusion of additional parent training would lead to an improved long-term weight course of obese children. Parents of obese children (n = 686; 7-13 years old) either participated in complementary cognitive-behavioral group sessions (n = 336) or received written information only (n = 350) during the inpatient stay. Children of both groups attended multidisciplinary inpatient rehabilitation. BMI-SDS as a primary outcome was evaluated at baseline, post-intervention and at 6- and 12-month follow-up. Intention-to-treat (ITT) as well as per-protocol analyses (PPA) were performed. A significant within-group decrease of 0.24 (95% CI 0.18 to 0.30) BMI-SDS points from the beginning of the inpatient stay through the first year was found, but no group difference at the one-year follow-up (mean difference 0.02; 95% CI -0.04 to 0.07). We also observed an increase in quality of life scores, intake of healthy food and exercise for both groups, without differences between groups (ITT and PPA). Thus, while the inpatient treatment proved highly effective, additional parent training did not lead to better results in long-term weight maintenance or to better psychosocial well-being compared to written psycho-educational material. Further research should focus on subgroups to answer the question of differential treatment effects. Copyright © 2016 Elsevier Ltd. All rights reserved.

  10. Randomised clinical trial: enteral nutrition does not improve the long-term outcome of alcoholic cirrhotic patients with jaundice.

    Science.gov (United States)

    Dupont, B; Dao, T; Joubert, C; Dupont-Lucas, C; Gloro, R; Nguyen-Khac, E; Beaujard, E; Mathurin, P; Vastel, E; Musikas, M; Ollivier, I; Piquet, M-A

    2012-05-01

    Malnutrition and jaundice are independent prognostic factors in cirrhosis. To assess the impact of enteral nutrition on the survival of alcoholic cirrhotic patients with jaundice but without acute alcoholic hepatitis. The study was a multicentre prospective randomised controlled trial comparing effects of enteral nutrition vs. a symptomatic support in patients with alcoholic cirrhosis and jaundice (bilirubin ≥51 µmol/L) but without severe acute alcoholic hepatitis. A total of 99 patients were randomised to receive either the conventional symptomatic treatment (55 patients) or the symptomatic support associated with 35 kcal/Kg/day of enteral nutrition during 4 weeks followed by an oral nutritional support during 2 months (44 patients). Randomisation was stratified on nutritional status. One-year survival curves were compared using the Kaplan-Meier method and Logrank test. Populations in both arms were similar. One-year survival was similar in the overall population (27/44 patients (61.4%) in the enteral nutrition arm vs. 36/55 (65.5%) in the control arm; Logrank P = 0.60) and in the subgroup suffering from malnutrition [18/29 patients (62.1%) in the enteral nutrition arm vs. 20/32 (62.5%) in the control arm; Logrank P = 0.99]. There was no statistical difference for bilirubin, prothrombin rate, Child-Pugh score, albumin or nutritional assessment. Complications during treatment (bleeding, encephalopathy, infection) occurred in 23% of patients in the enteral nutrition group (10/44) vs. 16% (9/55) of the control patients (P = 0.59). Enteral nutrition does not improve the survival and hepatic or nutritional parameters of cirrhotic patients with jaundice. © 2012 Blackwell Publishing Ltd.

  11. LONG-TERM EFFECTS OF CHLORTHALIDONE VS HYDROCHLOROTHIAZIDE ON ELECTROCARDIOGRAPHIC LEFT VENTRICULAR HYPERTROPHY IN THE MULTIPLE RISK FACTOR INTERVENTION TRIAL

    Science.gov (United States)

    Ernst, Michael E.; Neaton, James D.; Grimm, Richard H.; Collins, Gary; Thomas, William; Soliman, Elsayed Z.; Prineas, Ronald J.

    2011-01-01

    Chlorthalidone (CTD) reduces 24-hour blood pressure more effectively than hydrochlorothiazide (HCTZ), but whether this influences electrocardiographic left ventricular hypertrophy (LVH) is uncertain. One source of comparative data is the Multiple Risk Factor Intervention Trial (MRFIT), which randomly assigned 8,012 hypertensive men to special intervention (SI) or usual care (UC). SI participants could use CTD or HCTZ initially; previous analyses have grouped clinics by their main diuretic used (C-clinics: CTD; H-clinics: HCTZ). After 48 months, SI participants receiving HCTZ were recommended to switch to CTD, in part, because higher mortality was observed for SI compared to UC participants in H-clinics, while the opposite was found in C-clinics. In this analysis, we examined change in continuous measures of electrocardiographic LVH using both an ecologic analysis by previously-reported C- or H-clinic groupings, and an individual participant analysis where use of CTD or HCTZ by SI participants was considered and updated annually. Through 48 months, differences between SI and UC in LVH were larger for C-clinics compared to H-clinics (Sokolow-Lyon: −93.9 vs −54.9 μV, P=0.049; Cornell voltage: −68.1 vs −35.9 μV, P=0.019; Cornell voltage product: −4.6 vs −2.2 μV/ms, P=0.071; left ventricular mass: −4.4 vs −2.8 gm, P=0.002). At the individual participant level, Sokolow-Lyon and left ventricular mass were significantly lower for SI men receiving CTD compared to HCTZ through 48 months and 84 months of follow-up. Our findings on LVH support the idea that greater blood pressure reduction with CTD than HCTZ may have led to differences in mortality observed in MRFIT. PMID:22025372

  12. Feasibility and acceptability of group music therapy vs wait-list control for treatment of patients with long-term depression (the SYNCHRONY trial): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Carr, Catherine Elizabeth; O'Kelly, Julian; Sandford, Stephen; Priebe, Stefan

    2017-03-29

    Depression is of significant global concern. Despite a range of effective treatment options it is estimated that around one in five diagnosed with an acute depressive episode continue to experience enduring symptoms for more than 2 years. There is evidence for effectiveness of individual music therapy for depression. However, no studies have as yet looked at a group intervention within an NHS context. This study aims to assess the feasibility of conducting a randomised controlled trial of group music therapy for patients with long-term depression (symptom durations of 1 year or longer) within the community. This is a single-centre randomised controlled feasibility trial of group music therapy versus wait-list control with a nested process evaluation. Thirty participants will be randomised with unbalanced allocation (20 to receive the intervention immediately, 10 as wait-list controls). Group music therapy will be offered three times per week in a community centre with a focus on songwriting. Data will be collected post-intervention, 3 and 6 months after the intervention finishes. We will examine the feasibility of recruitment processes including identifying the number of eligible participants, participation and retention rates and the intervention in terms of testing components, measuring adherence and estimation of the likely intervention effect. A nested process evaluation will consist of treatment fidelity analysis, exploratory analysis of process measures and end-of-participation interviews with participants and referring staff. Whilst group music therapy is an option in some community mental health settings, this will be the first study to examine group music therapy for this particular patient group. We will assess symptoms of depression, acceptability of the intervention and quality of life. We anticipate potential challenges in the recruitment and retention of participants. It is unclear whether offering the intervention three times per week will be

  13. The second therapeutic trial for children with hematological malignancies who relapsed after their first allogeneic SCT: long-term outcomes.

    Science.gov (United States)

    Nishikawa, Takuro; Inagaki, Jiro; Nagatoshi, Yoshihisa; Fukano, Reiji; Nakashima, Kentaro; Ito, Nobuhiro; Sawa, Daisuke; Kawano, Yoshifumi; Okamura, Jun

    2012-11-01

    The impact of a second all-SCT on the long-term outcomes of children who relapse after allo-SCT has been unclear. We retrospectively analyzed the long-term outcomes of different salvage treatments for such children. Sixty-six children with hematological malignancies (40 ALL, 22 AML, three MDS, and one CML) who relapsed after a first allo-SCT received either a second allo-SCT (n = 16) or CTx and/or DLI (n = 50). The median follow-up for all children was 9.1 yr. The five-yr OS after relapse was significantly better in patients who underwent a second allo-SCT (42.9%) than in patients treated with CTx and/or DLI (11.8%) (p SCT, two died more than five yr after the second allo-SCT. A second allo-SCT can therefore lead to a prolonged OS in patients who relapse after allo-SCT. However, a second allo-SCT should be selected carefully. This is because the mortality rate is still high, even when there is an extensive duration of time following the second allo-SCT. © 2012 John Wiley & Sons A/S.

  14. Individualized nutrition intervention is of major benefit to colorectal cancer patients: long-term follow-up of a randomized controlled trial of nutritional therapy.

    Science.gov (United States)

    Ravasco, Paula; Monteiro-Grillo, Isabel; Camilo, Maria

    2012-12-01

    In our published randomized trial in colorectal cancer, group 1 (n = 37) received individualized nutritional counseling and education about regular foods, group 2 (n = 37) received dietary supplements and consumed their usual diet of regular foods, and group 3 (n = 37) consumed their usual diet of regular foods. Neither group 2 nor group 3 received individualized counseling. Early nutritional counseling during radiotherapy was highly effective at reducing acute radiotherapy toxicity and improving nutritional intake/status and quality of life (QoL). Efficacy persisted for 3 mo after the intervention. The objective was to perform long-term follow-up in survivors of that clinical trial to specifically evaluate survival, late toxicity, QoL, and nutritional variables. Medical data were collected from patients' records, and prescheduled interviews were conducted by dietitians for individualized evaluations. Analyses and comparisons between groups (adjusted for stage) were performed after a median follow-up of 6.5 (range: 4.9-8.1) y. Patients complied with the Radiotherapy Department's follow-up protocol. Nutritional deterioration was higher (P nutritional status was maintained in 91% of group 1 patients but not in any of the group 3 patients (P group 2 > group 1 (P group 1 (P nutritional status and intake (P nutritional status, and QoL predicted shorter survival and late toxicity (HR: 8.25; 95% CI: 2.74, 1.47; P nutrition at improving long-term prognosis in colorectal cancer. Overall, the data indicate that early individualized nutritional counseling and education during radiotherapy is valuable for patients.

  15. Long-term remineralizing effect of MI Paste Plus on regression of early caries after orthodontic fixed appliance treatment: a 12-month follow-up randomized controlled trial.

    Science.gov (United States)

    Beerens, Moniek W; Ten Cate, Jacob M; Buijs, Mark J; van der Veen, Monique H

    2017-11-17

    Casein-phosphopeptide-amorphous-calcium-fluoride-phosphate (CPP-ACFP) can remineralize subsurface lesions. It is the active ingredient of MI-Paste-Plus® (MPP). The long-term remineralization efficacy is unknown. To evaluate the long-term effect of MPP versus a placebo paste on remineralization of enamel after fixed orthodontic treatment over a 12-month period. This trial was designed as a prospective, double-blinded, placebo-controlled RCT. Patients with subsurface lesions scheduled for removal of the appliance were included. They applied either MPP or control paste once a day at bedtime for 12 months, complementary to normal oral hygiene. Changes in enamel lesions (primary outcome) were fluorescence loss and lesion area determined by quantitative light-induced fluorescence (QLF). Secondary outcomes were Microbial composition, by conventional plating, and acidogenicity of plaque, by capillary ion analysis (CIA), and lesion changes scored visually on clinical photographs. Participants [age = 15.5 years (SD = 1.6)] were randomly assigned to either the MPP or the control group, as determined by a computer-randomization scheme, created and locked before the start of the study. Participants received neutral-coloured concealed toothpaste tubes marked A or B. The patients and the observers were blinded with respect to the content of tube A or B. A total of 51 patients were analysed; MPP (n = 25) versus control group (n = 26); data loss (n = 14). There was no significant difference between the groups over time for all the used outcome measures. There was a significant improvement in enamel lesions (fluorescence loss) over time in both groups (P orthodontic fixed appliance treatment did not improve these lesions during the 1 year following debonding. This trial is registered at the medical ethical committee of the VU Medical Centre in Amsterdam (NL.199226.029.07). © The Author 2017. Published by Oxford University Press on behalf of the European Orthodontic Society

  16. Radiation Therapy Did Not Induce Long-Term Changes in Rectal Mucosa: Results From the Randomized Scandinavian Prostate Cancer Group 7 Trial

    Energy Technology Data Exchange (ETDEWEB)

    Slagsvold, Jens Erik, E-mail: Jens.Erik.Slagsvold@stolav.no [Cancer Clinic, St. Olavs Hospital, Trondheim University Hospital, Trondheim (Norway); Viset, Trond [Department of Pathology, St. Olavs Hospital, Trondheim University Hospital, Trondheim (Norway); Wibe, Arne [Institute of Cancer Research and Molecular Medicine, Norwegian University of Science and Technology, Trondheim (Norway); Department of Surgery, St. Olavs Hospital, Trondheim University Hospital, Trondheim (Norway); Kaasa, Stein [Cancer Clinic, St. Olavs Hospital, Trondheim University Hospital, Trondheim (Norway); European Palliative Care Research Center, Department of Cancer Research and Molecular Medicine, Faculty of Medicine, Norwegian University of Science and Technology, Trondheim (Norway); Widmark, Anders [Department of Radiation Sciences, Cancercentrum, Umeå (Sweden); Lund, Jo-Åsmund [Cancer Clinic, St. Olavs Hospital, Trondheim University Hospital, Trondheim (Norway); European Palliative Care Research Center, Department of Cancer Research and Molecular Medicine, Faculty of Medicine, Norwegian University of Science and Technology, Trondheim (Norway)

    2016-07-15

    Purpose: To investigate long-term changes in the rectal mucosa after curative external beam radiation therapy in the treatment of prostate cancer. Methods and Materials: In the Scandinavian Prostate Cancer Group 7 trial, 880 men with locally advanced prostate cancer were randomized to hormonal therapy alone versus hormonal therapy plus radiation therapy to 70 Gy. A subcohort from this trial being randomized at our center (n=178) was invited to a study on late anorectal side effects during 2003-2005, approximately 5 years after treatment, including measuring health-reported quality of life and physician-assessed toxicity score by the Late Effects Normal Tissue Task Force/Subjective, Objective, Management, Analytic (LENT/SOMA) and European Organization for Research and Treatment of Cancer/Radiation Therapy Oncology Group score. Sixty-seven patients had a rectal mucosa biopsy. Sixty-four biopsies were included in the final analysis, of which 33 patients were randomized to hormonal treatment and 31 to hormonal treatment plus radiation therapy. The presence of fibrosis, number of capillaries, and lymphocyte infiltration was then evaluated by light microscopy. Results: The group receiving radiation therapy had significantly higher LENT/SOMA and function/bother scale scores than the group that only received hormonal treatment, but there was no significant difference in the presence of fibrosis, ectasia, number of capillaries in the lamina propria, or lymphocyte infiltration between the groups. Conclusion: Radiation therapy to 70 Gy to the prostate does not induce long-term microscopic mucosal changes in the rectum 5 years after treatment. This is in contrast to the general assumption that structural changes, including fibrosis, seen after radiation therapy include the mucosa. We speculate that the main late effects of radiation therapy on the structure of the rectum are located in the deeper layers of the rectal wall than the mucosa.

  17. Efficacy and short-term safety of topical Dwarf Elder (Sambucus ebulus L.) versus diclofenac for knee osteoarthritis: A randomized, double-blind, active-controlled trial.

    Science.gov (United States)

    Jabbari, Marzie; Hashempur, Mohammad Hashem; Razavi, Seyede Zahra Emami; Shahraki, Hadi Raeisi; Kamalinejad, Mohammad; Emtiazy, Majid

    2016-07-21

    Sambucus ebulus L. (S. ebulus) has had long-standing application in Traditional Persian Medicine for joint pain and for a variety of bone and joint disorders. According to traditional use of S. ebulus and its relevant pharmacologic properties, this study was designed to evaluate the efficacy and short-term safety of topical use of S. ebulus in patients with knee osteoarthritis (OA). Seventy nine patients with knee OA were randomly enrolled in 2 parallel arms of a pilot randomized, double-blind, active-controlled clinical trial. The patients were treated by topical S. ebulus gel or 1% diclofenac gel, three times a day, as much as a fingertip unit for 4 weeks. Patients were assessed prior to enrollment and, then, 2 and 4 weeks subsequent to the intervention, in terms of scores of visual analogue scale (VAS) for self-grading of their knee joint pain, and according to 3 different domains of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire. Any observed adverse effects were also scrutinized. The mean values of WOMAC pain score, total WOMAC score and VAS score for pain of the S. ebulus group were significantly lower compared with the diclofenac group (P=0.004, P=0.04, and P<0.001, respectively). In addition, no serious adverse effect was reported. This pilot study showed that topical treatment with S. ebulus gel can be recommended for alleviating symptoms of patients with knee OA. However, longer trials involving larger samples size, are needed for achieving a comprehensive understanding about the efficacy and safety of S. ebulus in knee OA. Copyright © 2016. Published by Elsevier Ireland Ltd.

  18. Long-term oncological outcomes of a phase II trial of neoadjuvant chemohormonal therapy followed by radical prostatectomy for patients with clinically localised, high-risk prostate cancer.

    Science.gov (United States)

    Silberstein, Jonathan L; Poon, Stephen A; Sjoberg, Daniel D; Maschino, Alexandra C; Vickers, Andrew J; Bernie, Aaron; Konety, Badrinath R; Kelly, W Kevin; Eastham, James A

    2015-07-01

    To determine long-term oncological outcomes of radical prostatectomy (RP) after neoadjuvant chemohormonal therapy (CHT) for clinically localised, high-risk prostate cancer. In this phase II multicentre trial of patients with high-risk prostate cancer (PSA level >20 ng/mL, Gleason ≥8, or clinical stage ≥T3), androgen-deprivation therapy (goserelin acetate depot) and paclitaxel, carboplatin and estramustine were administered before RP. We report the long-term oncological outcomes of these patients and compared them to a contemporary cohort who met oncological inclusion criteria but received RP only. In all, 34 patients were enrolled and followed for a median of 13.1 years. Within 10 years most patients had biochemical recurrence (BCR-free probability 22%; 95% confidence interval [CI] 10-37%). However, the probability of disease-specific survival at 10 years was 84% (95% CI 66-93%) and overall survival was 78% (95% CI 60-89%). The CHT group had higher-risk features than the comparison group (123 patients), with an almost doubled risk of calculated preoperative 5-year BCR (69% vs 36%, P < 0.01). After adjusting for these imbalances the CHT group had trends toward improvement in BCR (hazard ratio [HR] 0.76, 95% CI 0.43-1.34; P = 0.3) and metastasis-free survival (HR 0.55, 95% CI 0.24-1.29; P = 0.2) although these were not statistically significant. Neoadjuvant CHT followed by RP was associated with lower rates of BCR and metastasis compared with the RP-only group; however, these results were not statistically significant. Because this treatment strategy has known harms and unproven benefit, this strategy should only be instituted in the setting of a clinical trial. © 2014 The Authors BJU International © 2014 BJU International Published by John Wiley & Sons Ltd.

  19. Long-term Cosmetic Outcomes and Toxicities of Proton Beam Therapy Compared With Photon-Based 3-Dimensional Conformal Accelerated Partial-Breast Irradiation: A Phase 1 Trial

    International Nuclear Information System (INIS)

    Galland-Girodet, Sigolène; Pashtan, Itai; MacDonald, Shannon M.; Ancukiewicz, Marek; Hirsch, Ariel E.; Kachnic, Lisa A.; Specht, Michelle; Gadd, Michele; Smith, Barbara L.; Powell, Simon N.; Recht, Abram; Taghian, Alphonse G.

    2014-01-01

    Purpose: To present long-term outcomes of a prospective feasibility trial using either protons or 3-dimensional conformal photon-based (accelerated partial-breast irradiation [APBI]) techniques. Methods and Materials: From October 2003 to April 2006, 98 evaluable patients with stage I breast cancer were treated with APBI (32 Gy in 8 fractions given twice daily) on a prospective clinical trial: 19 with proton beam therapy (PBT) and 79 with photons or mixed photons/electrons. Median follow-up was 82.5 months (range, 2-104 months). Toxicity and patient satisfaction evaluations were performed at each visit. Results: At 7 years, the physician rating of overall cosmesis was good or excellent for 62% of PBT patients, compared with 94% for photon patients (P=.03). Skin toxicities were more common for the PBT group: telangiectasia, 69% and 16% (P=.0013); pigmentation changes, 54% and 22% (P=.02); and other late skin toxicities, 62% and 18% (P=.029) for PBT and photons, respectively. There were no significant differences between the groups in the incidences of breast pain, edema, fibrosis, fat necrosis, skin desquamation, and rib pain or fracture. Patient-reported cosmetic outcomes at 7 years were good or excellent for 92% and 96% of PBT and photon patients, respectively (P=.95). Overall patient satisfaction was 93% for the entire cohort. The 7-year local failure rate for all patients was 6%, with 3 local recurrences in the PBT group (7-year rate, 11%) and 2 in photon-treated patients (4%) (P=.22). Conclusions: Local failure rates of 3-dimensional APBI and PBT were similar in this study. However, PBT, as delivered in this study, led to higher rates of long-term telangiectasia, skin color changes, and skin toxicities. We recommend the use of multiple fields and treatment of all fields per treatment session or the use of scanning techniques to minimize skin toxicity

  20. Long-term Cosmetic Outcomes and Toxicities of Proton Beam Therapy Compared With Photon-Based 3-Dimensional Conformal Accelerated Partial-Breast Irradiation: A Phase 1 Trial

    Energy Technology Data Exchange (ETDEWEB)

    Galland-Girodet, Sigolène; Pashtan, Itai; MacDonald, Shannon M.; Ancukiewicz, Marek [Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts (United States); Hirsch, Ariel E.; Kachnic, Lisa A. [Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts (United States); Department of Radiation Oncology, Boston Medical Center, Boston University School of Medicine, Boston, Massachusetts (United States); Specht, Michelle; Gadd, Michele; Smith, Barbara L. [Department of Surgical Oncology, Massachusetts General Hospital, Boston, Massachusetts (United States); Powell, Simon N. [Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts (United States); Recht, Abram [Department of Radiation Oncology, Beth Israel Deaconess Medical Center, Boston, Massachusetts (United States); Taghian, Alphonse G., E-mail: ataghian@partners.org [Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts (United States)

    2014-11-01

    Purpose: To present long-term outcomes of a prospective feasibility trial using either protons or 3-dimensional conformal photon-based (accelerated partial-breast irradiation [APBI]) techniques. Methods and Materials: From October 2003 to April 2006, 98 evaluable patients with stage I breast cancer were treated with APBI (32 Gy in 8 fractions given twice daily) on a prospective clinical trial: 19 with proton beam therapy (PBT) and 79 with photons or mixed photons/electrons. Median follow-up was 82.5 months (range, 2-104 months). Toxicity and patient satisfaction evaluations were performed at each visit. Results: At 7 years, the physician rating of overall cosmesis was good or excellent for 62% of PBT patients, compared with 94% for photon patients (P=.03). Skin toxicities were more common for the PBT group: telangiectasia, 69% and 16% (P=.0013); pigmentation changes, 54% and 22% (P=.02); and other late skin toxicities, 62% and 18% (P=.029) for PBT and photons, respectively. There were no significant differences between the groups in the incidences of breast pain, edema, fibrosis, fat necrosis, skin desquamation, and rib pain or fracture. Patient-reported cosmetic outcomes at 7 years were good or excellent for 92% and 96% of PBT and photon patients, respectively (P=.95). Overall patient satisfaction was 93% for the entire cohort. The 7-year local failure rate for all patients was 6%, with 3 local recurrences in the PBT group (7-year rate, 11%) and 2 in photon-treated patients (4%) (P=.22). Conclusions: Local failure rates of 3-dimensional APBI and PBT were similar in this study. However, PBT, as delivered in this study, led to higher rates of long-term telangiectasia, skin color changes, and skin toxicities. We recommend the use of multiple fields and treatment of all fields per treatment session or the use of scanning techniques to minimize skin toxicity.

  1. Long-Term Improvement in Treatment Outcome After Radiotherapy and Hyperthermia in Locoregionally Advanced Cervix Cancer: An Update of the Dutch Deep Hyperthermia Trial

    International Nuclear Information System (INIS)

    Franckena, Martine; Stalpers, Lukas J.A.; Koper, Peter C.M.; Wiggenraad, Ruud G.J.; Hoogenraad, Wim J.; Dijk, Jan D.P. van; Warlam-Rodenhuis, Carla C.; Jobsen, Jan J.; Rhoon, Gerard C. van; Zee, Jacoba van der

    2008-01-01

    Purpose: The local failure rate in patients with locoregionally advanced cervical cancer is 41-72% after radiotherapy (RT) alone, whereas local control is a prerequisite for cure. The Dutch Deep Hyperthermia Trial showed that combining RT with hyperthermia (HT) improved 3-year local control rates of 41-61%, as we reported earlier. In this study, we evaluate long-term results of the Dutch Deep Hyperthermia Trial after 12 years of follow-up. Methods and Materials: From 1990 to 1996, a total of 114 women with locoregionally advanced cervical carcinoma were randomly assigned to RT or RT + HT. The RT was applied to a median total dose of 68 Gy. The HT was given once weekly. The primary end point was local control. Secondary end points were overall survival and late toxicity. Results: At the 12-year follow-up, local control remained better in the RT + HT group (37% vs. 56%; p = 0.01). Survival was persistently better after 12 years: 20% (RT) and 37% (RT + HT; p = 0.03). World Health Organization (WHO) performance status was a significant prognostic factor for local control. The WHO performance status, International Federation of Gynaecology and Obstetrics (FIGO) stage, and tumor diameter were significant for survival. The benefit of HT remained significant after correction for these factors. European Organization for Research and Treatment of Cancer Grade 3 or higher radiation-induced late toxicities were similar in both groups. Conclusions: For locoregionally advanced cervical cancer, the addition of HT to RT resulted in long-term major improvement in local control and survival without increasing late toxicity. This combined treatment should be considered for patients who are unfit to receive chemotherapy. For other patients, the optimal treatment strategy is the subject of ongoing research

  2. Short-term effects of a rights-based sexuality education curriculum for high-school students: a cluster-randomized trial.

    Science.gov (United States)

    Constantine, Norman A; Jerman, Petra; Berglas, Nancy F; Angulo-Olaiz, Francisca; Chou, Chih-Ping; Rohrbach, Louise A

    2015-03-26

    An emerging model for sexuality education is the rights-based approach, which unifies discussions of sexuality, gender norms, and sexual rights to promote the healthy sexual development of adolescents. A rigorous evaluation of a rights-based intervention for a broad population of adolescents in the U.S. has not previously been published. This paper evaluates the immediate effects of the Sexuality Education Initiative (SEI) on hypothesized psychosocial determinants of sexual behavior. A cluster-randomized trial was conducted with ninth-grade students at 10 high schools in Los Angeles. Classrooms at each school were randomized to receive either a rights-based curriculum or basic sex education (control) curriculum. Surveys were completed by 1,750 students (N = 934 intervention, N = 816 control) at pretest and immediate posttest. Multilevel regression models examined the short-term effects of the intervention on nine psychosocial outcomes, which were hypothesized to be mediators of students' sexual behaviors. Compared with students who received the control curriculum, students receiving the rights-based curriculum demonstrated significantly greater knowledge about sexual health and sexual health services, more positive attitudes about sexual relationship rights, greater communication about sex and relationships with parents, and greater self-efficacy to manage risky situations at immediate posttest. There were no significant differences between the two groups for two outcomes, communication with sexual partners and intentions to use condoms. Participation in the rights-based classroom curriculum resulted in positive, statistically significant effects on seven of nine psychosocial outcomes, relative to a basic sex education curriculum. Longer-term effects on students' sexual behaviors will be tested in subsequent analyses. ClinicalTrials.gov NCT02009046.

  3. Predictors for contrast media-induced nephropathy and long-term survival: Prospectively assessed data from the randomized controlled Dialysis-Versus-Diuresis (DVD) trial

    Science.gov (United States)

    Hölscher, Birgit; Heitmeyer, Christine; Fobker, Manfred; Breithardt, Günter; Schaefer, Roland M; Reinecke, Holger

    2008-01-01

    BACKGROUND: Among the numerous studies concerning contrast media-induced nephropathy (CIN), there was no prospective trial that provided data on the long-term outcomes. OBJECTIVES: To prospectively assess predictors of CIN and long-term outcomes of affected patients. METHODS: Four hundred twelve consecutive patients with serum creatinine levels of 115 μmol/L to 309 μmol/L (1.3 mg/dL to 3.5 mg/dL) undergoing elective coronary angiography were included. Patients were randomly assigned to periprocedural hydration alone, hydration plus onetime hemodialysis or hydration plus N-acetylcysteine. RESULTS: Multivariate logistic regression identified the following as predictors of CIN within 72 h (equivalent to an increase in creatinine 44.2 μmol/L [0.5 mg/dL] or more) : prophylactic postprocedural hemodialysis (OR 2.86, 95% CI 1.07 to 7.69), use of angiotensin-converting enzyme inhibitors (OR 6.16, 95% CI 2.01 to 18.93), baseline glomerular filtration rate (OR 0.94, 95% CI 0.90 to 0.98) and the amount of contrast media given (OR 1.01, 95% CI 1.00 to 1.01). With regard to long-term outcome (mean follow-up 649 days), multivariate Cox regression models found elevated creatinine levels at 30 days (hazard rate ratio [HRR] 5.48, 95% CI 2.85 to 10.53), but not CIN within 72 h (HRR 1.12, 95% CI 0.63 to 2.02), to be associated with increased mortality. In addition, independent predictors for death during follow-up included left ventricular ejection fraction lower than 35% (HRR 4.01, 95% CI 2.22 to 7.26), serum phosphate (HRR 1.64, 95% CI 1.10 to 2.43) and hemoglobin (HRR 0.80, 95% CI 0.67 to 0.96). CONCLUSION: From the present prospective trial, performance of post-procedural hemodialysis, use of angiotensin-converting enzyme inhibitors, reduced baseline glomerular filtration rate and amount of contrast media were independent predictors of CIN within 72 h after catheterization. Assessing renal function after 30 days, rather than within 72 h, seemed to be more predictive for

  4. Long-Term Pain Treatment Did Not Improve Sleep in Nursing Home Patients with Comorbid Dementia and Depression: A 13-Week Randomized Placebo-Controlled Trial

    Directory of Open Access Journals (Sweden)

    Kjersti M. Blytt

    2018-02-01

    Full Text Available Objective: Previous research indicates that pain treatment may improve sleep among nursing home patients. We aimed to investigate the long-term effect of pain treatment on 24-h sleep patterns in patients with comorbid depression and dementia.Design: A 13-week, multicenter, parallel-group, double-blind, placebo-controlled randomized clinical trial conducted between August 2014 and September 2016.Setting: Long-term patients from 47 nursing homes in Norway.Participants: We included 106 patients with comorbid dementia and depression according to the Mini Mental Status Examination (MMSE and the Cornell Scale for Depression in Dementia (CSDD.Intervention: Patients who were not using analgesics were randomized to receive either paracetamol (3 g/day or placebo tablets. Those who already received pain treatment were randomized to buprenorphine transdermal system (maximum 10 μg/h/7 days or placebo transdermal patches.Measurements: Sleep was assessed continuously for 7 days by actigraphy, at baseline and in week 13. Total sleep time (TST, sleep efficiency (SE, sleep onset latency (SOL, wake after sleep onset (WASO, early morning awakening (EMA, and number of wake bouts (NoW were evaluated. In addition, daytime total sleep time (DTS was estimated. Pain was assessed with Mobilization-Observation-Behavior-Intensity-Dementia-2 Pain Scale (MOBID-2.Results: The linear mixed model analyses for TST, SE, SOL, WASO, EMA, NoW and DTS showed no statistically significant differences between patients who received active pain treatment and those who received placebo. Post hoc subgroup analyses showed that there were no statistically significant differences between active treatment and placebo from baseline to week 13 in patients who were in pain (MOBID-2 ≥ 3 at baseline, or in patients who had poor sleep (defined as SE < 85% at baseline. Patients who received active buprenorphine showed an increase in TST and SE compared to those who received active paracetamol

  5. The effects of maxillary protraction and its long-term stability--a clinical trial in Chinese adolescents.

    Science.gov (United States)

    Chen, LinLing; Chen, RongJing; Yang, YiMing; Ji, GuoPing; Shen, Gang

    2012-02-01

    The purpose of this study was to evaluate the effect of reverse pull headgear (RPHG) in the treatment of Class III malocclusions in the late mixed and early permanent dentition and its long-term stability at the time when facial growth was close to completion. The treatment group comprised 22 subjects (12 males and 10 females, mean age: 11.38 ± 0.69 years). The control group included 17 subjects (7 males and 10 females, mean age: 11.54 ± 1.07 years). The mean RPHG treatment time was 1.5 ± 0.95 years and the observation time for the control group was 1.75 ± 0.83 years. For each subject, lateral cephalograms were obtained before (T1) and after (T2) treatment or observation. These cephalograms were traced and analyzed and the differences between T1 and T2 values were examined with paired t-tests. Of the 22 treated cases, 10 patients were followed up until at the mean age of 16.18 years (T3). Since there was no relapse in anterior crossbite, the long-term effects of RPHG were evaluated by measuring the maxillary and mandibular skeletal changes. The follow-up patients were divided into two groups based on the change in ANB: a stable group (decrease in ANB 2 degrees). The skeletal effects of RPHG in treating Class III anomalies just before or at the beginning of the pubertal growth spurt include protraction of the maxilla and dentition and inhibition of forward growth of the mandible. With regard to the long-term change, a slight alteration in the position of the maxilla and in the position and growth direction of the mandible resulted in a slight decrease in ANB in the stable group. The slight retrusion in the maxilla, combined with the significant protrusion in the mandible and the more horizontal mandibular growth direction, resulted in a decrease in ANB in the unstable group. This indicated that the maxilla remained relatively stable and that the unstable factor was continuing mandibular growth during the pubertal and post-pubertal period. For patients with an

  6. Effectiveness of zinc supplementation to full term normal infants: a community based double blind, randomized, controlled, clinical trial.

    Directory of Open Access Journals (Sweden)

    K V Radhakrishna

    Full Text Available The study was aimed to test whether zinc supplementation, if initiated early, can prevent stunting and promote optimum body composition in full term infants. For this, full term pregnant women from low income urban community were enrolled and were followed-up for 24 months postpartum. Body mass index (BMI was calculated from maternal weight and height that were collected one month after delivery. Infants' weight, and length, head, chest and mid upper arm circumferences and skin fold thicknesses at triceps, biceps and subscapular area were collected at baseline (before randomization and once in three months up till 24 months. Three hundred and twenty four infants were randomized and allocated to zinc (163 or placebo (161 groups respectively. Supplementation of zinc was initiated from 4 months of age and continued till children attained 18 months. The control (placebo group of children received riboflavin 0.5 mg/day, whereas the intervention (zinc group received 5 mg zinc plus riboflavin 0.5 mg/day. When infants were 18 months old, dietary intakes (in 78 children were calculated by 24 hour diet recall method and hemoglobin, zinc, copper and vitamin A were quantified in blood samples collected from 70 children. The results showed prevalence of undernutrition (body mass index <18.5 in 37% of the mothers. Mean±SD calorie consumption and zinc intakes from diets in infants were 590±282.8 Kcal/day and 0.97±0.608 mg/day respectively. Multiple linear regression models demonstrated maternal weight as a strong predictor of infants' weight and length at 18 months of age. As expected, diarrhea duration impacted infants' linear growth and weight gain adversely. Zinc supplementation for a mean period of 190 days, starting from 4 months up to 18 months of age, in full term normal infants, consuming an average energy of 590 Kcal/day, had significant effect on the skin fold thicknesses, but not on their linear growth.Clinical Trail Registration India (CTRI CTRI

  7. Once more unto the breech: the firearms evidence in the Sacco and Vanzetti case revisited: Part I.

    Science.gov (United States)

    Starrs, J E

    1986-04-01

    The Sacco and Vanzetti case has a timeless appeal. It raises trenchant issues of the fairness of a criminal trial in the face of the public's hue and cry. It is a sorry reminder that physical evidence must be closeted with care and punctiliously marked for later courtroom uses. Claims of unfairness at the trial of Sacco and Vanzetti have evoked doubts of their guilt. On this issue, a Select Committee of firearms experts in 1983 reevaluated the existing firearms evidence from the Sacco and Vanzetti trial. Its conclusions, a number of which point unerringly to the guilt of Sacco and none of which add a scintilla to the case against Vanzetti, are analyzed in this paper, which is in two parts. Part I sets the stage by focussing on the facts of the crime in South Braintree, MA and the prosecutorial strategies in the use of the firearms evidence at the trial in Dedham, MA. The firearms evidence against Vanzetti is analyzed separately from that marshalled against Sacco. Part II will address the rampant charges of governmental misconduct in the handling of the firearms evidence. A concluding section of Part II reveals startling new evidence relevant to the guilt of Nicola Sacco.

  8. Long-term results of a randomized controlled trial evaluating preoperative chemotherapy in resectable non-small cell lung cancer

    Directory of Open Access Journals (Sweden)

    Chen ZW

    2013-06-01

    Full Text Available Zhiwei Chen,* Qingquan Luo,* Hong Jian, Zhen Zhou, Baijun Cheng, Shun Lu, Meilin LiaoShanghai Lung Tumor Clinical Medical Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, People’s Republic of China *These authors contributed equallyObjective: We aimed to evaluate whether preoperative chemotherapy provides benefits in the survival and prognosis of patients with non-small cell lung cancer (NSCLC in resectable stages I to IIIA, except T1N0. Methods: In this randomized, controlled trial, 356 patients with stage I (except for T1N0, II and IIIA NSCLC were assigned to either the preoperative chemotherapy plus surgery arm (179 patients or the primary surgery arm (177 patients. Both treatments were followed by adjuvant chemotherapy. The end point of this study included overall survival (OS, progression-free survival (PFS, and survival rate associated with clinical remission. Results: Statistical survival difference was found between the preoperative chemotherapy plus surgery arm and the surgery-alone arm. However, the median survival time (MST in the preoperative chemotherapy arm was lower than that of surgery-alone arm (MST, 45.42 months vs 57.59 months (P = 0.016. When comparing the effect of preoperative chemotherapy at each stage of NSCLC, a statistical survival difference was found in stage II NSCLC but not in stage I and IIIA (MST 40.86 months vs 80.81 months (P = 0.044. However, no statistically significant difference in PFS was noticed between the two arms, except for stage I NSCLC (hazard radio [HR] = 0.87; 95% CI, 0.561−1.629; P = 0.027. The survival rate was higher for patients who had clinical remission after preoperative chemotherapy, but the differences did not reach statistical significance (MST 42.10 months vs 35.33 months (P = 0.630. Conclusion: Preoperative chemotherapy did not show benefits in OS and PFS for stage I-IIIA NSCLC patients. Keywords: NSCLC, neoadjuvent, mitomycin, cisplatin, vindesine

  9. Client satisfaction among participants in a randomized trial comparing oral methadone and injectable diacetylmorphine for long-term opioid-dependency

    Directory of Open Access Journals (Sweden)

    Brissette Suzanne

    2011-07-01

    Full Text Available Abstract Background Substitution with opioid-agonists (e.g., methadone has shown to be an effective treatment for chronic long-term opioid dependency. Patient satisfaction with treatment has been associated with improved addiction treatment outcomes. However, there is a paucity of studies evaluating patients' satisfaction with Opioid Substitution Treatment (OST. In the present study, participants' satisfaction with OST was evaluated at 3 and 12 months. We sought to test the relationship between satisfaction and patients' characteristics, the treatment modality received and treatment outcomes. Methods Data from a randomized controlled trial, the North American Opiate Medication Initiative (NAOMI, conducted in Vancouver and Montreal (Canada between 2005-2008, was analyzed. The NAOMI study compared the effectiveness of oral methadone vs. injectable diacetylmorphine over 12 months. A small sub-group of patients received injectable hydromorphone on a double blind basis with diacetylmorphine. The Client Satisfaction Questionnaire (CSQ-8 was used to measure satisfaction with treatment. CSQ-8 scores, as well as retention and response to treatment, did not differ between those receiving hydromorphone and diacetylmorphine at 3 or 12 months assessments; therefore, these two groups were analyzed together as the 'injectable' treatment group. Results A total of 232 (92% and 237 (94% participants completed the CSQ-8 at 3 and 12 months, respectively. Participants in both groups were highly satisfied with treatment. Independent of treatment group, participants satisfied with treatment at 3 months were more likely to be retained at 12 months. Multivariate analysis indicated that satisfaction was greater among those randomized to the injection group after controlling for treatment effectiveness. Participants who were retained, responded to treatment, and had fewer psychological symptoms were more satisfied with treatment. Finally, open-ended comments were made by

  10. A Novel Study Paradigm for Long-term Prevention Trials in Alzheimer Disease: The Placebo Group Simulation Approach (PGSA): Application to MCI data from the NACC database.

    Science.gov (United States)

    Berres, M; Kukull, W A; Miserez, A R; Monsch, A U; Monsell, S E; Spiegel, R

    2014-01-01

    The PGSA (Placebo Group Simulation Approach) aims at avoiding problems of sample representativeness and ethical issues typical of placebo-controlled secondary prevention trials with MCI patients. The PGSA uses mathematical modeling to forecast the distribution of quantified outcomes of MCI patient groups based on their own baseline data established at the outset of clinical trials. These forecasted distributions are then compared with the distribution of actual outcomes observed on candidate treatments, thus substituting for a concomitant placebo group. Here we investigate whether a PGSA algorithm that was developed from the MCI population of ADNI 1*, can reliably simulate the distribution of composite neuropsychological outcomes from a larger, independently selected MCI subject sample. Data available from the National Alzheimer's Coordinating Center (NACC) were used. We included 1523 patients with single or multiple domain amnestic mild cognitive impairment (aMCI) and at least two follow-ups after baseline. In order to strengthen the analysis and to verify whether there was a drift over time in the neuropsychological outcomes, the NACC subject sample was split into 3 subsamples of similar size. The previously described PGSA algorithm for the trajectory of a composite neuropsychological test battery (NTB) score was adapted to the test battery used in NACC. Nine demographic, clinical, biological and neuropsychological candidate predictors were included in a mixed model; this model and its error terms were used to simulate trajectories of the adapted NTB. The distributions of empirically observed and simulated data after 1, 2 and 3 years were very similar, with some over-estimation of decline in all 3 subgroups. The by far most important predictor of the NTB trajectories is the baseline NTB score. Other significant predictors are the MMSE baseline score and the interactions of time with ApoE4 and FAQ (functional abilities). These are essentially the same predictors

  11. Long-term effect of inhaled budesonide in mild and moderate chronic obstructive pulmonary disease: a randomised controlled trial

    DEFF Research Database (Denmark)

    Vestbo, Jørgen; Sørensen, T; Lange, Peter

    1999-01-01

    BACKGROUND: Little is known about the long-term efficacy of inhaled corticosteroids in chronic obstructive pulmonary disease (COPD). We investigated the efficacy of inhaled budesonide on decline in lung function and respiratory symptoms in a 3-year placebo-controlled study of patients with COPD....... METHODS: We used a parallel-group, randomised, double-blind, placebo-controlled design in a singlecentre study, nested in a continuing epidemiological survey (the Copenhagen City Heart Study). Inclusion criteria were as follows: no asthma; a ratio of forced expiratory volume in 1 s (FEV1) and vital...... capacity of 0.7 or less; FEV1 which showed no response (budesonide, 800 microg plus 400 microg daily for 6 months followed by 400 microg twice daily for 30 months, or placebo...

  12. A randomized controlled trial of a supported employment program for persons with long-term mental illness in Hong Kong.

    Science.gov (United States)

    Kin Wong, Kenny; Chiu, Rose; Tang, Betty; Mak, Donald; Liu, Joanne; Chiu, Siu Ning

    2008-01-01

    Supported employment is an evidence-based practice that has proved to be consistently more effective than conventional vocational rehabilitation in helping people with severe mental illness find and sustain competitive employment. Most research on the effectiveness of supported employment comes from the United States. This study examined the effectiveness and applicability of a supported employment program based on the individual placement and support model in a Hong Kong setting. Ninety-two unemployed individuals with long-term mental illness who desired competitive employment were randomly assigned to either a supported employment program or a conventional vocational rehabilitation program and followed up for 18 months. Both vocational and nonvocational outcomes were measured. Over the 18-month study period, compared with participants in the conventional vocational rehabilitation program, those in the supported employment group were more likely to work competitively (70% versus 29%; odds ratio=5.63, 95% confidence interval=2.28-13.84), held a greater number of competitive jobs, earned more income, worked more days, and sustained longer job tenures. Repeated-measures analysis of variance found no substantive differences between participants in the two groups and no significant change from baseline over time for psychiatric symptoms and self-perceived quality of life. Consistent with previous research findings in the United States, the supported employment program was more effective than the conventional vocational rehabilitation program in helping individuals with long-term mental illness find and sustain competitive employment in a Hong Kong setting. The supported employment program based on the individual placement and support model can thus be recommended for wider use in local mental health practice.

  13. Survival in Malnourished Older Patients Receiving Post-Discharge Nutritional Support; Long-Term Results of a Randomized Controlled Trial.

    Science.gov (United States)

    Neelemaat, F; van Keeken, S; Langius, J A E; de van der Schueren, M A E; Thijs, A; Bosmans, J E

    2017-01-01

    Previous analyses have shown that a post-discharge individualized nutritional intervention had positive effects on body weight, lean body mass, functional limitations and fall incidents in malnourished older patients. However, the impact of this intervention on survival has not yet been studied. The objective of this randomized controlled study was to examine the effect of a post-discharge individualized nutritional intervention on survival in malnourished older patients. Malnourished older patients, aged ≥ 60 years, were randomized during hospitalization to a three-months post-discharge nutritional intervention group (protein and energy enriched diet, oral nutritional supplements, vitamin D3/calcium supplement and telephone counseling by a dietitian) or to a usual care regimen (control group). Survival data were collected 4 years after enrollment. Survival analyses were performed using intention-to-treat analysis by Log-rank tests and Cox regression adjusted for confounders. The study population consisted of 94 men (45%) and 116 women with a mean age of 74.5 (SD 9.5) years. There were no statistically significant differences in baseline characteristics. Survival data was available in 208 out of 210 patients. After 1 and 4 years of follow-up, survival rates were respectively 66% and 29% in the intervention group (n=104) and 73% and 30% in the control group (n=104). There were no statistically significant differences in survival between the two groups 1 year (HR= 0.933, 95% CI=0.675-1.289) and 4 years after enrollment (HR=0.928, 95% CI=0.671-1.283). The current study failed to show an effect of a three-months post-discharge multi-component nutritional intervention in malnourished older patients on long-term survival, despite the positive effects on short-term outcome such as functional limitations and falls.

  14. An interactive health communication application for supporting parents managing childhood long-term conditions: outcomes of a randomized controlled feasibility trial.

    Science.gov (United States)

    Swallow, Veronica M; Knafl, Kathleen; Santacroce, Sheila; Campbell, Malcolm; Hall, Andrew G; Smith, Trish; Carolan, Ian

    2014-12-03

    Families living with chronic or long-term conditions such as chronic kidney disease (CKD), stages 3-5, face multiple challenges and respond to these challenges in various ways. Some families adapt well while others struggle, and family response to a condition is closely related to outcome. With families and professionals, we developed a novel condition-specific interactive health communication app to improve parents' management ability-the online parent information and support (OPIS) program. OPIS consists of a comprehensive mix of clinical caregiving and psychosocial information and support. The purpose of this study was to (1) assess feasibility of a future full-scale randomized controlled trial (RCT) of OPIS in terms of recruitment and retention, data collection procedures, and psychometric performance of the study measures in the target population, and (2) investigate trends in change in outcome measures in a small-scale RCT in parents of children with CKD stages 3-5. Parents were recruited from a pediatric nephrology clinic and randomly assigned to one of two treatment groups: usual support for home-based clinical caregiving (control) or usual support plus password-protected access to OPIS for 20 weeks (intervention). Both groups completed study measures at study entry and exit. We assessed feasibility descriptively in terms of recruitment and retention rates overall; assessed recruitment, retention, and uptake of the intervention between groups; and compared family condition management, empowerment to deliver care, and fathers' involvement between groups. We recruited 55 parents of 39 children (42% of eligible families). Of those, about three-quarters of intervention group parents (19/26, 73%) and control group parents (22/29, 76%) were retained through completion of 20-week data collection. The overall retention rate was 41/55 (75%). The 41 parents completing the trial were asked to respond to the same 10 questionnaire scales at both baseline and 20 weeks

  15. Nifedipine as a uterine relaxant for external cephalic version: a randomized controlled trial.

    Science.gov (United States)

    Kok, Marjolein; Bais, Joke M; van Lith, Jan M; Papatsonis, Dimitri M; Kleiverda, Gunilla; Hanny, Dahrs; Doornbos, Johannes P; Mol, Ben W; van der Post, Joris A

    2008-08-01

    To estimate the effectiveness of nifedipine as a uterine relaxant during external cephalic version to correct breech presentation. In this randomized, double-blind, placebo-controlled trial, women with a singleton fetus in breech presentation and a gestational age of 36 weeks or more were eligible for enrollment. Participating women received two doses of either nifedipine 10 mg or placebo, 30 and 15 minutes before the external cephalic version attempt. The primary outcome was a cephalic-presenting fetus immediately after the procedure. Secondary outcome measures were cephalic presentation at delivery, mode of delivery, and adverse events. A sample size of 292 was calculated to provide 80% power to detect a 17% improvement of the external cephalic version success rate, assuming a placebo group rate of 40% and alpha of .05. Outcome data for 310 of 320 randomly assigned participants revealed no significant difference in external cephalic version success rates between treatment (42%) and control group (37%) (relative risk 1.1, 95%; 95% confidence interval 0.85-1.5). The cesarean delivery rate was 51% in the treatment group and 46% in the control group (relative risk 1.1, 95% confidence interval 0.88-1.4). Nifedipine did not significantly improve the success of external cephalic version. Future use of nifedipine to improve the outcome of external cephalic version should be limited to large clinical trials.

  16. Effect of early institutionalization and foster care on long-term white matter development: a randomized clinical trial.

    Science.gov (United States)

    Bick, Johanna; Zhu, Tong; Stamoulis, Catherine; Fox, Nathan A; Zeanah, Charles; Nelson, Charles A

    2015-03-01

    Severe neglect in early life is associated with compromises in brain development and associated behavioral functioning. Although early intervention has been shown to support more normative trajectories of brain development, specific improvements in the white matter pathways that underlie emotional and cognitive development are unknown. To examine associations among neglect in early life, early intervention, and the microstructural integrity of white matter pathways in middle childhood. The Bucharest Early Intervention Project is a randomized clinical trial of high-quality foster care as an intervention for institutionally reared children in Bucharest, Romania, from 2000 through the present. During infancy, children were randomly selected to remain in an institution or to be placed in foster care. Those who remained in institutions experienced neglect, including social, emotional, linguistic, and cognitive impoverishment. Developmental trajectories of these children were compared with a group of sociodemographically matched children reared in biological families at baseline and several points throughout development. At approximately 8 years of age, 69 of the original 136 children underwent structural magnetic resonance imaging scans. Four estimates of white matter integrity (fractional anisotropy [FA] and mean [MD], radial [RD], and axial [AD] diffusivity) for 48 white matter tracts throughout the brain were obtained through diffusion tensor imaging. Significant associations emerged between neglect in early life and microstructural integrity of the body of the corpus callosum (FA, β = 0.01 [P = .01]; RD, β = -0.02 [P = .005]; MD, β = -0.01 [P = .02]) and tracts involved in limbic circuitry (fornix crus [AD, β = 0.02 (P = .046)] and cingulum [RD, β = -0.01 (P = .02); MD, β = -0.01 (P = .049)]), frontostriatal circuitry (anterior [AD, β = -0.01 (P = .02)] and superior [AD, β = -0.02 (P = .02); MD, β = -0.01 (P = .03)] corona

  17. Ketamine analgesia for inflammatory pain in neonatal rats: a factorial randomized trial examining long-term effects

    Directory of Open Access Journals (Sweden)

    Bhutta Adnan T

    2008-08-01

    Full Text Available Abstract Background Neonatal rats exposed to repetitive inflammatory pain have altered behaviors in young adulthood, partly ameliorated by Ketamine analgesia. We examined the relationships between protein expression, neuronal survival and plasticity in the neonatal rat brain, and correlated these changes with adult cognitive behavior. Methods Using Western immunoblot techniques, homogenates of cortical tissue were analyzed from neonatal rats 18–20 hours following repeated exposure to 4% formalin injections (F, N = 9, Ketamine (K, 2.5 mg/kg × 2, N = 9, Ketamine prior to formalin (KF, N = 9, or undisturbed controls (C, N = 9. Brain tissues from another cohort of rat pups (F = 11, K = 12, KF = 10, C = 15 were used for cellular staining with Fos immunohistochemistry or FluoroJade-B (FJB, followed by cell counting in eleven cortical and three hippocampal areas. Long-term cognitive testing using a delayed non-match to sample (DNMS paradigm in the 8-arm radial maze was performed in adult rats receiving the same treatments (F = 20, K = 24, KF = 21, C = 27 in the neonatal period. Results Greater cell death occurred in F vs. C, K, KF in parietal and retrosplenial areas, vs. K, KF in piriform, temporal, and occipital areas, vs. C, K in frontal and hindlimb areas. In retrosplenial cortex, less Fos expression occurred in F vs. C, KF. Cell death correlated inversely with Fos expression in piriform, retrosplenial, and occipital areas, but only in F. Cortical expression of glial fibrillary acidic protein (GFAP was elevated in F, K and KF vs. C. No significant differences occurred in Caspase-3, Bax, and Bcl-2 expression between groups, but cellular changes in cortical areas were significantly correlated with protein expression patterns. Cluster analysis of the frequencies and durations of behaviors grouped them as exploratory, learning, preparatory, consumptive, and foraging behaviors. Neonatal inflammatory pain exposure reduced exploratory behaviors in adult

  18. Short-term intravenous antimicrobial prophylaxis for elective rectal cancer surgery: results of a prospective randomized non-inferiority trial.

    Science.gov (United States)

    Ishibashi, Keiichiro; Ishida, Hideyuki; Kuwabara, Kouki; Ohsawa, Tomonori; Okada, Norimichi; Yokoyama, Masaru; Kumamoto, Kensuke

    2014-04-01

    To investigate the non-inferiority of postoperative single-dose intravenous antimicrobial prophylaxis to multiple-dose intravenous antimicrobial prophylaxis in terms of the incidence of surgical site infections (SSIs) in patients undergoing elective rectal cancer surgery by a prospective randomized study. Patients undergoing elective surgery for rectal cancer were randomized to receive a single intravenous injection of flomoxef (group 1) or five additional doses (group 2) of flomoxef after the surgery. All the patients had received preoperative oral antibiotic prophylaxis (kanamycin and erythromycin) after mechanical cleansing within 24 h prior to surgery, and had received intravenous flomoxef during surgery. A total of 279 patients (including 139 patients in group 1 and 140 in group 2) were enrolled in the study. The incidence of SSIs was 13.7% in group 1 and 13.6% in group 2 (difference [95% confidence interval]: -0.2% [-0.9 to 0.7%]). The incidence of SSIs was not significantly different in patients undergoing elective rectal surgery who were treated using a single dose of postoperative antibiotics compared to those treated using multiple-dose antibiotics when preoperative mechanical and chemical bowel preparations were employed.

  19. Short-term tibolone does not interfere with endothelial function: a double-blinded, randomized, controlled trial.

    Science.gov (United States)

    Celani, M F S; Hurtado, R; Brandão, A H F; Maciel da Fonseca, A M R; Geber, S

    2016-06-01

    Objective To evaluate the effect of short-term hormone replacement therapy with tibolone 2.5 mg daily on endothelial function of healthy postmenopausal women, using flow-mediated dilation (FMD) of the brachial artery. Methods We performed a randomized, double-blinded, placebo-controlled study. A total of 100 healthy postmenopausal women were randomly allocated to receive tibolone (n = 50) or placebo (n = 50) for 28 days. Measurement of the FMD of the brachial artery was performed before and after the use of tibolone and placebo. Results A total of 31 women completed the study in the tibolone group, and 32 women completed the study in the control group. The results of the FMD measurements obtained from the women in the two groups before treatment were similar (0.018 and 0.091, for tibolone and placebo, p = 0.57). The values of the FMD in women who used tibolone and placebo, before and after the treatment, were similar in both groups. The numbers of women who presented an increase in the values of the FMD in both groups were also similar. Conclusion Our results demonstrate that the administration of 2.5 mg tibolone to healthy postmenopausal women for 28 days does not promote endothelial-dependent vasodilation, measured by FMD of the brachial artery.

  20. A long-term evaluation of the stage of change approach and compensable injury outcomes - a cluster-randomised trial.

    Science.gov (United States)

    Rothmore, Paul; Aylward, Paul; Gray, Jodi; Karnon, Jonathan

    2017-05-01

    This study investigated the long-term injury outcomes for workers in companies from a range of industries which had been randomly allocated to receive ergonomics interventions tailored according to the stage of change (SOC) approach or standard ergonomics advice. Differences in compensable injury outcomes between the groups were analysed using logistic regression models. Questionnaire results from face-to-face interviews to assess musculoskeletal pain and discomfort (MSPD), job satisfaction and other factors were also analysed. Although not significant at the 0.05 level, after adjusting for workgroup clustering, workers in receipt of tailored advice were 55% (OR = 0.45, 95% CI = 0.19-1.08) less likely to report a compensable injury than those in receipt of standard ergonomics advice. Workload, job satisfaction and MSPD were significantly correlated with injury outcomes. The observed outcomes support the potential value of the SOC approach, as well as highlighting the need to consider workload, job satisfaction and MSPD when planning injury prevention programmes. Practitioner Summary: This study investigated compensable injury outcomes for workers who had received ergonomics advice tailored according to the stage of change (SOC) approach compared with standard ergonomics advice. The results support the potential value of the SOC approach and highlight the need to consider workload, job satisfaction and musculoskeletal pain and discomfort when planning injury prevention interventions.

  1. Long-term effects of the Mediterranean lifestyle program: a randomized clinical trial for postmenopausal women with type 2 diabetes

    Directory of Open Access Journals (Sweden)

    Ritzwoller Debra P

    2007-01-01

    Full Text Available Abstract Background Multiple-risk-factor interventions offer a promising means for addressing the complex interactions between lifestyle behaviors, psychosocial factors, and the social environment. This report examines the long-term effects of a multiple-risk-factor intervention. Methods Postmenopausal women (N = 279 with type 2 diabetes participated in the Mediterranean Lifestyle Program (MLP, a randomized, comprehensive lifestyle intervention study. The intervention targeted healthful eating, physical activity, stress management, smoking cessation, and social support. Outcomes included lifestyle behaviors (i.e., dietary intake, physical activity, stress management, smoking cessation, psychosocial variables (e.g., social support, problem solving, self-efficacy, depression, quality of life, and cost analyses at baseline, and 6, 12, and 24 months. Results MLP participants showed significant 12- and 24-month improvements in all targeted lifestyle behaviors with one exception (there were too few smokers to analyze tobacco use effects, and in psychosocial measures of use of supportive resources, problem solving, self-efficacy, and quality of life. Conclusion The MLP was more effective than usual care over 24 months in producing improvements on behavioral and psychosocial outcomes. Directions for future research include replication with other populations.

  2. Infection and immunity in Down syndrome: a trial of long-term low oral doses of zinc.

    Science.gov (United States)

    Lockitch, G; Puterman, M; Godolphin, W; Sheps, S; Tingle, A J; Quigley, G

    1989-05-01

    To determine whether orally administered zinc supplements could correct the abnormal humoral and cell-mediated immunity of Down syndrome, we randomly assigned 64 children with Down syndrome, aged 1 to 19 years and living at home, to receive either zinc gluconate or placebo daily for 6-month periods with crossover from one regimen to another. Control subjects were siblings and age-matched, unrelated children. Serum zinc, copper, and measures of immune system competence were tested at 3- or 6-month intervals. Parents kept daily logs of clinical symptoms such as cough and diarrhea and of physician visits. Mean serum zinc concentrations increased to about 150% of baseline during zinc supplementation, but we found no effect on serum levels of copper, immunoglobulins, or complement; on lymphocyte number or subset distribution; or on in vitro response to mitogens. Children with Down syndrome who were receiving zinc had a trend toward fewer days or episodes of cough and fever but no change in other clinical variables. Long-term, low-dose oral zinc supplementation to improve depressed immune response or to decrease infections in children with Down syndrome cannot be recommended.

  3. Prediction of Long-Term Benefits of Inhaled Steroids by Phenotypic Markers in Moderate-to-Severe COPD: A Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Jiska B Snoeck-Stroband

    Full Text Available The decline in lung function can be reduced by long-term inhaled corticosteroid (ICS treatment in subsets of patients with chronic obstructive pulmonary disease (COPD. We aimed to identify which clinical, physiological and non-invasive inflammatory characteristics predict the benefits of ICS on lung function decline in COPD.Analysis was performed in 50 steroid-naive compliant patients with moderate to severe COPD (postbronchodilator forced expiratory volume in one second (FEV1, 30-80% of predicted, compatible with GOLD stages II-III, age 45-75 years, >10 packyears smoking and without asthma. Patients were treated with fluticasone propionate (500 μg bid or placebo for 2.5 years. Postbronchodilator FEV1, dyspnea and health status were measured every 3 months; lung volumes, airway hyperresponsiveness (PC20, and induced sputum at 0, 6 and 30 months. A linear mixed effect model was used for analysis of this hypothesis generating study.Significant predictors of attenuated FEV1-decline by fluticasone treatment compared to placebo were: fewer packyears smoking, preserved diffusion capacity, limited hyperinflation and lower inflammatory cell counts in induced sputum (p<0.04.Long-term benefits of ICS on lung function decline in patients with moderate-to-severe COPD are most pronounced in patients with fewer packyears, and less severe emphysema and inflammation. These data generate novel hypotheses on phenotype-driven therapy in COPD.ClinicalTrials.gov NCT00158847.

  4. Internet-delivered cognitive-behavioural therapy v. conventional guided self-help for bulimia nervosa: long-term evaluation of a randomised controlled trial.

    Science.gov (United States)

    Wagner, Gudrun; Penelo, Eva; Wanner, Christian; Gwinner, Paulina; Trofaier, Marie-Louise; Imgart, Hartmut; Waldherr, Karin; Wöber-Bingöl, Ciçek; Karwautz, Andreas F K

    2013-02-01

    Cognitive-behavioural therapy (CBT)-based guided self-help is recommended as a first step in the treatment of bulimia nervosa. To evaluate in a randomised controlled trial (Clinicaltrials.gov registration number: NCT00461071) the long-term effectiveness of internet-based guided self-help (INT-GSH) compared with conventional guided bibliotherapy (BIB-GSH) in females with bulimia nervosa. A total of 155 participants were randomly assigned to INT-GSH or BIB-GSH for 7 months. Outcomes were assessed at baseline, month 4, month 7 and month 18. The greatest improvement was reported after 4 months with a continued reduction in eating disorder symptomatology reported at month 7 and 18. After 18 months, 14.6% (n = 7/48) of the participants in the INT-GSH group and 25% (n = 7/28) in the BIB-GSH group were abstinent from binge eating and compensatory measures, 43.8% (n = 21/48) and 39.2% (n = 11/28) respectively were in remission. No differences regarding outcome between the two groups were found. Internet-based guided self-help for bulimia nervosa was not superior compared with bibliotherapy, the gold standard of self-help. Improvements remain stable in the long term.

  5. Long-term follow-up of HIV-1-infected adults who received the F4/AS01B HIV-1 vaccine candidate in two randomised controlled trials.

    Science.gov (United States)

    Harrer, Thomas; Dinges, Warren; Roman, François

    2018-05-03

    This Phase I/II, open, long-term follow-up study was conducted in antiretroviral therapy (ART)-naïve (N = 212) and ART-treated (N = 19) human immunodeficiency virus 1 (HIV-1)-infected adults, who received an HIV-1 investigational vaccine (F4/AS01 B ) or placebo in two previous studies (NCT00814762 and NCT01218113). After a minimum of two years and a maximum of four years of follow-up post-vaccination per patient, no significant differences were observed between F4/AS01 B and placebo groups in terms of viral load, CD4 + T-cell count and incidence of specific clinical events. Vaccine-induced polyfunctional CD4 + T-cells persisted up to study end and no relevant vaccine-related safety events were reported in F4/AS01 B groups. This study has been registered at ClinicalTrials.gov (NCT01092611). Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

  6. Comparison between the effects of trigger point mesotherapy versus acupuncture points mesotherapy in the treatment of chronic low back pain: a short term randomized controlled trial.

    Science.gov (United States)

    Di Cesare, Annalisa; Giombini, Arrigo; Di Cesare, Mariachiara; Ripani, Maurizio; Vulpiani, Maria Chiara; Saraceni, Vincenzo Maria

    2011-02-01

    The goal of this study was to compare the effects of trigger point (TRP) mesotherapy and acupuncture (ACP) mesotherapy in the treatment of patients with chronic low back pain. Short term randomized controlled trial. 62 subjects with chronic low back pain were recruited at outpatients Physical Medicine and Rehabilitation Clinic at the University of Rome "La Sapienza" in the period between July 2006 and May 2008. Study subjects were assigned to receive 4 weeks treatments with either trigger point mesotherapy (TRP mesotherapy, n=29) or acupoints mesotherapy (ACP mesotherapy, n=33). Pain intensity with a pain visual analogic scale (VAS) and verbal rating scale (VRS) and pain disability with McGill Pain Questionnaire Short Form (SFMPQ), Roland Morris Disability Questionnaire (RMQ) and Oswestry Low Back Pain Disability Questionaire (ODQ). ACP mesotherapy shows a more effective results in VRS and VAS measures in the follow-up (p(VRS)=mesotherapy group. Our results suggest that the response to ACP mesotherapy may be greater than the response to TRP mesotherapy in the short term follow-up. This technique could be nevertheless a viable option as an adjunct treatment in an overall treatment planning of CLBP. Copyright © 2010 Elsevier Ltd. All rights reserved.

  7. A randomised trial of enteral glutamine supplementation for very preterm children showed no beneficial or adverse long-term neurodevelopmental outcomes.

    Science.gov (United States)

    Twilhaar, E Sabrina; de Kieviet, Jorrit F; Oosterlaan, Jaap; van Elburg, Ruurd M

    2018-04-01

    This study evaluated the long-term effects of enteral glutamine supplementation on neurodevelopmental outcomes of a Dutch cohort of very preterm children at 13 years of age. The cohort was enrolled in a randomised placebo-controlled trial between 2001 and 2003 in which infants received glutamine- or alanine-supplemented enteral nutrition during the first month of life. Participants were invited for follow-up at a mean age of 13.30 years. Motor, neurocognitive, academic and behavioural outcomes were assessed in 61 children. No differences were found between the groups regarding motor, intellectual, academic and behavioural functioning. Forward span visuospatial working memory performance was better in the controls (crude/adjusted model: d = 0.67/0.64, p = 0.02/0.02), but no difference was found for backward span. After the data were adjusted for confounders, the groups differed regarding parent-rated attention (crude/adjusted model: d = 0.47/0.73, p = 0.07/0.003), but both groups scored within the normal range. This was the first study on the long-term effects of enteral glutamine supplementation on the neurodevelopmental outcomes of very preterm children. Our study provided no evidence that enteral glutamine supplementation had any beneficial or adverse effects on the children's motor, neurocognitive, academic and behavioural outcomes at 13 years of age. ©2017 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.

  8. Long-term clinical and prosthetic outcomes of soft liner and clip attachments for bar/implant overdentures: a randomised controlled clinical trial.

    Science.gov (United States)

    ELsyad, M A; Shaheen, N H; Ashmawy, T M

    2017-06-01

    Long-term clinical and prosthetic outcomes of soft liner attachments for bar/implant overdentures were not sufficiently investigated. The aim of this trial was to evaluate clinical and prosthetic outcomes of resilient liner and clip attachments for bar/implant-retained mandibular overdenture after 7 years. Thirty edentulous male participants received two implants in the canine areas of the mandible. Three months later, implants were splinted with a resilient bar. Mandibular overdentures were connected to the bars with either clip (CR group, n = 15) or resilient liner (RR group, n = 15) attachments. Plaque index (PI), gingival index (GI), probing depth (PD), vertical bone loss (VBL), horizontal bone loss (HBLO) and prosthetic complications (PCs) were evaluated at denture delivery (T0), 6 (T 6m ), 12 (T1), 24 (T2), 36 (T3), 48 (T4), 60 (T5), 72 (T6) and 84 (T7) months after insertion. PI and GI increased significantly with time for CR and decreased significantly for RR (P overdentures than clip attachments in terms of peri-implant tissue health and prosthetic complications after 7 years. © 2017 John Wiley & Sons Ltd.

  9. Comparison of Fetomaternal Outcome between 47 Deliveries Following Successful External Cephalic Version for Breech Presentation and 7456 Deliveries Following Spontaneous Cephalic Presentation.

    Science.gov (United States)

    de Gregorio, Nikolaus; Friedl, Thomas; Schramm, Amelie; Reister, Frank; Janni, Wolfgang; Ebner, Florian

    2017-08-25

    Achieving a cephalic position after a successful external cephalic version (ECV) is desired to result in delivery and fetal outcomes that are similar to those of deliveries following spontaneous cephalic presentation. We performed a retrospective cohort study including patients with successful ECV following fetal breech position (ECV cohort, n = 47) or with a singleton spontaneous cephalic pregnancy at ≥37 weeks of gestational age (control group, n = 7,456) attempting a vaginal delivery between 2010 and 2013 at the University Hospital Ulm. The mode of delivery and fetal outcome parameters were compared between these 2 groups using nonparametric statistics. ECV cohort and control group did not differ with respect to maternal age, parity, gestational age at birth, and fetal gender. There were no significant differences between the 2 groups with regard to all parameters indicating fetal outcome. However, the rate of cesarean sections was higher after successful ECV compared to spontaneous cephalic presentation (27.7 vs. 12.8%, OR 2.615). While vaginal delivery is less likely to happen after a successful ECV compared to spontaneous cephalic singleton pregnancies, fetal outcome parameters showed no difference between the 2 groups. Physicians should be counseling and encouraging women to attempt ECV, as it is a safe and effective procedure. © 2017 S. Karger AG, Basel.

  10. The effect of perioperative probiotics treatment for colorectal cancer: short-term outcomes of a randomized controlled trial.

    Science.gov (United States)

    Yang, Yongzhi; Xia, Yang; Chen, Hongqi; Hong, Leiming; Feng, Junlan; Yang, Jun; Yang, Zhe; Shi, Chenzhang; Wu, Wen; Gao, Renyuan; Wei, Qing; Qin, Huanlong; Ma, Yanlei

    2016-02-16

    This study was designed to mainly evaluate the anti-infective effects of perioperative probiotic treatment in patients receiving confined colorectal cancer (CRC) respective surgery. From November 2011 to September 2012, a total of 60 patients diagnosed with CRC were randomly assigned to receive probiotic (n = 30) or placebo (n = 30) treatment. The operative and post-operative clinical results including intestinal cleanliness, days to first - flatus, defecation, fluid diet, solid diet, duration of pyrexia, average heart rate, length of intraperitoneal drainage, length of antibiotic therapy, blood index changes, rate of infectious and non-infectious complications, postoperative hospital stay, and mortality were investigated. The patient demographics were not significantly different (p > 0.05) between the probiotic treated and the placebo groups. The days to first flatus (3.63 versus 3.27, p = 0.0274) and the days to first defecation (4.53 versus 3.87, p = 0.0268) were significantly improved in the probiotic treated patients. The incidence of diarrhea was significantly lower (p = 0.0352) in probiotics group (26.67%, 8/30) compared to the placebo group (53.33%, 16/30). There were no statistical differences (p > 0.05) in other infectious and non-infectious complication rates including wound infection, pneumonia, urinary tract infection, anastomotic leakage, and abdominal distension. In conclusion, for those patients undergoing confined CRC resection, perioperative probiotic administration significantly influenced the recovery of bowel function, and such improvement may be of important clinical significance in reducing the short-term infectious complications such as bacteremia.

  11. Types of urethral catheter for reducing symptomatic urinary tract infections in hospitalised adults requiring short-term catheterisation: multicentre randomised controlled trial and economic evaluation of antimicrobial- and antiseptic-impregnated urethral catheters (the CATHETER trial).

    Science.gov (United States)

    Pickard, R; Lam, T; Maclennan, G; Starr, K; Kilonzo, M; McPherson, G; Gillies, K; McDonald, A; Walton, K; Buckley, B; Glazener, C; Boachie, C; Burr, J; Norrie, J; Vale, L; Grant, A; N'dow, J

    2012-11-01

    Catheter-associated urinary tract infection (CAUTI) is a major preventable cause of harm for patients in hospital and incurs significant costs for health-care providers such as the UK NHS. Many preventative strategies and measures have been introduced to minimise CAUTI risk, including the use of antimicrobial catheters. However, there is considerable uncertainty regarding their usefulness in terms of reducing symptomatic CAUTI, and whether or not they are cost-effective. Do antimicrobial catheters reduce the rate of symptomatic urinary tract infection (UTI) during short-term hospital use and is their use cost-effective for the UK NHS? A pragmatic multicentre UK randomised controlled trial comparing three catheters as they would be used in the UK NHS: antimicrobial-impregnated (nitrofurazone) and antiseptic-coated (silver alloy) catheters with the standard polytetrafluoroethylene (PTFE)-coated catheters. Economic evaluation used a decision model populated with data from the trial. Sensitivity analysis was used to explore uncertainty. Relevant clinical departments in 24 NHS hospitals throughout the UK. Adults requiring temporary urethral catheterisation for a period of between 1 and 14 days as part of their care, predominantly as a result of elective surgery. Eligible participants were randomised 1 : 1 : 1 to one of three types of urethral catheter in order to make the following pragmatic comparisons: nitrofurazone-impregnated silicone catheter compared with standard PTFE-coated latex catheter; and silver alloy-coated hydrogel latex catheter compared with standard PTFE-coated latex catheter. The primary outcome for clinical effectiveness was the incidence of UTI at any time up to 6 weeks post randomisation. This was defined as any symptom reported during catheterisation, up to 3 days or 1 or 2 weeks post catheter removal or 6 weeks post randomisation combined with a prescription of antibiotics, at any of these times, for presumed symptomatic UTI. The primary economic

  12. Implementing structured functional assessments in general practice for persons with long-term sick leave: a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Benth Jūratė

    2009-05-01

    Full Text Available Abstract Background The increasing attention on functional assessments in medical and vocational rehabilitation requires a focus change for the general practitioners (GP into paying attention to patient resources, possibilities and coping instead of symptoms, problems and limitations. The GPs report difficulties in performing the requested explicit functional assessments. The purpose of this study was to implement a structured method in general practice for assessing functional ability in persons with long-term sick leave. The study aim was to evaluate intervention effects on important GP parameters; knowledge, attitudes, self-efficacy towards functional assessments and knowledge about patient work factors. Methods Fifty-seven GPs were randomly assigned to an intervention or a control group. The intervention group GPs attended an introductory one-day work-shop and implemented structured functional assessments during an eight months intervention period. GP knowledge, GP attitudes, and GP self-efficacy towards functional assessments, as well as GP knowledge of patient work factors, were collected before, after and six months after the intervention period started. Evaluation score-sheets were filled in by both the intervention GPs and their patients immediately after the consultation to evaluate the GPs' knowledge of patient work factors. Results The intervention GPs reported increased knowledge (B: 0.56, 95% CI (0.19, 0.91 and self-efficacy (B: 0.90, 95% CI (0.53, 1.26 towards functional assessments, and increased knowledge about their patients' workplace (B: 0.75, 95% CI (0.35, 1.15 and perceived stressors (B: 0.55, 95% CI (0.23, 0.88 with lasting effects at the second follow-up. No intervention effect was seen in relation to GP attitudes. Both before and after the intervention, the GPs were most informed about physical stressors, and less about mental and work organisational stressors (Guttman's reproducibility coefficient: 0.95 and 1.00. After

  13. Implementing structured functional assessments in general practice for persons with long-term sick leave: a cluster randomised controlled trial.

    Science.gov (United States)

    Østerås, Nina; Gulbrandsen, Pål; Benth, Jūrate Saltyte; Hofoss, Dag; Brage, Søren

    2009-05-06

    The increasing attention on functional assessments in medical and vocational rehabilitation requires a focus change for the general practitioners (GP) into paying attention to patient resources, possibilities and coping instead of symptoms, problems and limitations. The GPs report difficulties in performing the requested explicit functional assessments. The purpose of this study was to implement a structured method in general practice for assessing functional ability in persons with long-term sick leave. The study aim was to evaluate intervention effects on important GP parameters; knowledge, attitudes, self-efficacy towards functional assessments and knowledge about patient work factors. Fifty-seven GPs were randomly assigned to an intervention or a control group. The intervention group GPs attended an introductory one-day work-shop and implemented structured functional assessments during an eight months intervention period. GP knowledge, GP attitudes, and GP self-efficacy towards functional assessments, as well as GP knowledge of patient work factors, were collected before, after and six months after the intervention period started. Evaluation score-sheets were filled in by both the intervention GPs and their patients immediately after the consultation to evaluate the GPs' knowledge of patient work factors. The intervention GPs reported increased knowledge (B: 0.56, 95% CI (0.19, 0.91)) and self-efficacy (B: 0.90, 95% CI (0.53, 1.26)) towards functional assessments, and increased knowledge about their patients' workplace (B: 0.75, 95% CI (0.35, 1.15)) and perceived stressors (B: 0.55, 95% CI (0.23, 0.88)) with lasting effects at the second follow-up. No intervention effect was seen in relation to GP attitudes. Both before and after the intervention, the GPs were most informed about physical stressors, and less about mental and work organisational stressors (Guttman's reproducibility coefficient: 0.95 and 1.00). After the consultation, both the intervention GPs

  14. Long-term success of oral health intervention among care-dependent institutionalized seniors: Findings from a controlled clinical trial.

    Science.gov (United States)

    Schwindling, Franz Sebastian; Krisam, Johannes; Hassel, Alexander J; Rammelsberg, Peter; Zenthöfer, Andreas

    2018-04-01

    The purpose of this work was to investigate the long-term effectiveness of oral health education of caregivers in nursing homes with care-dependent and cognitively impaired residents. Fourteen nursing homes with a total of 269 residents were allocated to a control group, with continued normal care, or to an intervention group. Allocation was performed at nursing home level. In the intervention group, caregivers were given oral health education, and ultrasonic cleaning devices were provided to clean removable prostheses. Oral health was assessed at baseline and after 6 and 12 months by use of the Plaque Control Record (PCR), Gingival Bleeding Index (GBI), Community Periodontal Index of Treatment Needs (CPITN) and Denture Hygiene Index (DHI). Mixed models for repeated measures were performed for each target variable, with possible confounding factors (intervention/control group, age, sex, residence location and care-dependence). In the control group, no changes of target variables were observed between baseline and the 6- and 12-month follow-ups. After 6 and 12 months, PCR and DHI were significantly improved in the intervention group. For PCR, the intergroup difference of improvements was -14.4 (95% CI: -21.8; -6.9) after 6 months. After 12 months, the difference was -16.2 (95% CI: -27.7; -4.7). For DHI, the intergroup difference compared to baseline was -15 (95% CI: -23.6; -6.5) after 6 months and -13.3 (95% CI: -24.9; -1.8) after 12 months. There was neither a statistically significant effect on GBI nor on CPITN. Care-dependency showed a substantial trend to smaller improvements in PCR (P = .074), while an inverse effect was apparent for DHI (P < .001). Education of caregivers improves and maintains the oral health of care-dependent nursing home residents over longer periods. Use of ultrasonic devices is a promising means of improving denture hygiene among the severely care-dependent. Such interventions can be easily and cheaply implemented in routine daily care.

  15. Long-term biological and behavioural impact of an adolescent sexual health intervention in Tanzania: follow-up survey of the community-based MEMA kwa Vijana Trial.

    Directory of Open Access Journals (Sweden)

    Aoife M Doyle

    2010-06-01

    Full Text Available The ability of specific behaviour-change interventions to reduce HIV infection in young people remains questionable. Since January 1999, an adolescent sexual and reproductive health (SRH intervention has been implemented in ten randomly chosen intervention communities in rural Tanzania, within a community randomised trial (see below; NCT00248469. The intervention consisted of teacher-led, peer-assisted in-school education, youth-friendly health services, community activities, and youth condom promotion and distribution. Process evaluation in 1999-2002 showed high intervention quality and coverage. A 2001/2 intervention impact evaluation showed no impact on the primary outcomes of HIV seroincidence and herpes simplex virus type 2 (HSV-2 seroprevalence but found substantial improvements in SRH knowledge, reported attitudes, and some reported sexual behaviours. It was postulated that the impact on "upstream" knowledge, attitude, and reported behaviour outcomes seen at the 3-year follow-up would, in the longer term, lead to a reduction in HIV and HSV-2 infection rates and other biological outcomes. A further impact evaluation survey in 2007/8 ( approximately 9 years post-intervention tested this hypothesis.This is a cross-sectional survey (June 2007 through July 2008 of 13,814 young people aged 15-30 y who had attended trial schools during the first phase of the MEMA kwa Vijana intervention trial (1999-2002. Prevalences of the primary outcomes HIV and HSV-2 were 1.8% and 25.9% in males and 4.0% and 41.4% in females, respectively. The intervention did not significantly reduce risk of HIV (males adjusted prevalence ratio [aPR] 0.91, 95%CI 0.50-1.65; females aPR 1.07, 95%CI 0.68-1.67 or HSV-2 (males aPR 0.94, 95%CI 0.77-1.15; females aPR 0.96, 95%CI 0.87-1.06. The intervention was associated with a reduction in the proportion of males reporting more than four sexual partners in their lifetime (aPR 0.87, 95%CI 0.78-0.97 and an increase in reported

  16. Effects of selenium on short-term control of hyperthyroidism due to Graves' disease treated with methimazole: results of a randomized clinical trial.

    Science.gov (United States)

    Leo, M; Bartalena, L; Rotondo Dottore, G; Piantanida, E; Premoli, P; Ionni, I; Di Cera, M; Masiello, E; Sassi, L; Tanda, M L; Latrofa, F; Vitti, P; Marcocci, C; Marinò, M

    2017-03-01

    In spite of previous conflicting results, an adjuvant role of selenium in the treatment of Graves' disease (GD) hyperthyroidism has been proposed. To address this issue, a randomized clinical trial was carried out aimed at investigating whether selenium is beneficial on the short-term control of GD hyperthyroidism treated with methimazole (MMI). Thirty newly diagnosed hyperthyroid GD patients were randomly assigned to treatment with: (i) MMI or (ii) MMI plus selenium. Primary outcomes were: control of hyperthyroidism and clinical and biochemical manifestations of hyperthyroidism [heart rate, cholesterol, sex hormone-binding globulin (SHBG), hyperthyroidism symptoms] at 90 days. Baseline features of the two groups did not differ. Serum selenium at baseline was similar in the two groups and within the recommended range to define selenium sufficiency. Selenium increased with treatment in the MMI-selenium group and became significantly higher than in the MMI group. Serum malondialdehyde, a marker of oxidative stress, was similar in the two groups and decreased significantly with treatment, with no difference between groups. Administration of MMI was followed by a reduction of FT 3 and FT 4 , with no difference between groups. Heart rate, SHBG and symptoms of hyperthyroidism decreased, whereas total cholesterol increased in both groups with no difference between groups. Our study, carried out in a selenium-sufficient cohort of GD patients, failed to show an adjuvant role of selenium in the short-term control of hyperthyroidism. However, selenium might be beneficial in patients from selenium-deficient areas, as well as in the long-term outcome of antithyroid treatment.

  17. Effectiveness of Cranberry Capsules to Prevent Urinary Tract Infections in Vulnerable Older Persons: A Double-Blind Randomized Placebo-Controlled Trial in Long-Term Care Facilities

    Science.gov (United States)

    Caljouw, Monique A A; van den Hout, Wilbert B; Putter, Hein; Achterberg, Wilco P; Cools, Herman J M; Gussekloo, Jacobijn

    2014-01-01

    Objectives To determine whether cranberry capsules prevent urinary tract infection (UTI) in long-term care facility (LTCF) residents. Design Double-blind randomized placebo-controlled multicenter trial. Setting Long-term care facilities (LTCFs). Participants LTCF residents (N = 928; 703 women, median age 84). Measurements Cranberry and placebo capsules were taken twice daily for 12 months. Participants were stratified according to UTI risk (risk factors included long-term catheterization, diabetes mellitus, ≥1 UTI in preceding year). Main outcomes were incidence of UTI according to a clinical definition and a strict definition. Results In participants with high UTI risk at baseline (n = 516), the incidence of clinically defined UTI was lower with cranberry capsules than with placebo (62.8 vs 84.8 per 100 person-years at risk, P = .04); the treatment effect was 0.74 (95% confidence interval (CI) = 0.57–0.97). For the strict definition, the treatment effect was 1.02 (95% CI = 0.68–1.55). No difference in UTI incidence between cranberry and placebo was found in participants with low UTI risk (n = 412). Conclusion In LTCF residents with high UTI risk at baseline, taking cranberry capsules twice daily reduces the incidence of clinically defined UTI, although it does not reduce the incidence of strictly defined UTI. No difference in incidence of UTI was found in residents with low UTI risk. PMID:25180378

  18. Long-term use of minimal footwear on pain, self-reported function, analgesic intake, and joint loading in elderly women with knee osteoarthritis: A randomized controlled trial.

    Science.gov (United States)

    Trombini-Souza, Francis; Matias, Alessandra B; Yokota, Mariane; Butugan, Marco K; Goldenstein-Schainberg, Claudia; Fuller, Ricardo; Sacco, Isabel C N

    2015-12-01

    Efforts have been made to retard the progressive debilitating pain and joint dysfunction in patients with knee osteoarthritis. We aimed to evaluate the therapeutic effect of a low-cost minimalist footwear on pain, function, clinical and gait-biomechanical aspects of elderly women with knee osteoarthritis. Throughout a randomized, parallel and controlled clinical trial, fifty-six patients with medial knee osteoarthritis were randomly allocated to an intervention (n=28) or control group (n=28), and assessed at baseline and after three and six months. The intervention involved wearing Moleca(®) footwear for at least 6h/day, 7 days/week, over 6 months. The pain subscale of the Western Ontario and McMaster Universities Osteoarthritis Index was the primary outcome. The secondary outcomes were the other subscales, Lequesne score, distance walked in 6 min, knee oedema and effusion, knee adduction moment and paracetamol intake. Intention-to-treat analysis was performed using two-way casewise ANOVA (coefficient. Intervention group showed improvement in pain (effect size: 1.41, p<.001), function (effect size: 1.22, p=.001), stiffness (effect size: 0.76, p=.001), Lequesne score (effect size: 1.07, p<.001), and reduction by 21.8% in the knee adduction moment impulse (p=.017) during gait wearing Moleca(®). The analgesic intake was lower in the intervention group. The long-term use of Moleca(®) footwear relieves pain, improves self-reported function, reduces the knee loading while wearing Moleca(®), refrains the increase of analgesic intake in elderly women with knee osteoarthritis and can be considered as a conservative mechanical treatment option. ClinicalTrials.gov (NCT01342458). Copyright © 2015 Elsevier Ltd. All rights reserved.

  19. [(90)Yttrium-DOTA]-TOC response is associated with survival benefit in iodine-refractory thyroid cancer: long-term results of a phase 2 clinical trial.

    Science.gov (United States)

    Iten, Fabienne; Muller, Beat; Schindler, Christian; Rasch, Helmut; Rochlitz, Christoph; Oertli, Daniel; Maecke, Helmut R; Muller-Brand, Jan; Walter, Martin A

    2009-05-15

    The authors aimed to explore the efficacy of (90)Yttrium-1,4,7,10-tetra-azacyclododecane N,N',N'',N'''-tetraacetic acid [(90)Y-DOTA]-Tyr(3)-octreotide (TOC) in advanced iodine-refractory thyroid cancer. In a phase 2 trial, the authors investigated biochemical response (assessed by serum thyroglobulin levels), survival, and the long-term safety profile of systemic [(90)Y-DOTA]-TOC treatment in metastasized iodine-refractory thyroid cancer. Adverse events were assessed according to the National Cancer Institute criteria. Survival analyses were performed by using multiple regression models. A total of 24 patients were enrolled. A median cumulative activity of 13.0 GBq (range, 1.7-30.3 GBq) was administered. Response was found in 7 (29.2%) patients. Eight (33.3%) patients developed hematologic toxicity grade 1-3, and 4 (16.7%) patients developed renal toxicity grade 1-4. The median survival was 33.4 months (range, 3.6-126.8 months) from time of diagnosis and 16.8 months (range, 1.8-99.1 months) from time of first [(90)Y-DOTA]-TOC treatment. Response to treatment was associated with longer survival from time of diagnosis (hazard ratio [HR], 0.17; 95% confidence interval [CI], 0.03-0.92; P = .04) and from time of first [(90)Y-DOTA]-TOC therapy (HR, 0.20; 95% CI, 0.04-0.94; P = .04). The visual grade of scintigraphic tumor uptake was not associated with treatment response (odds ratio [OR], 0.98; 95% CI, 0.26-3.14; P = 1.00). Response to [(90)Y-DOTA]-TOC in metastasized iodine-refractory thyroid cancer was associated with longer survival. Upcoming trials should aim to increase the number of treatment cycles.

  20. The ethical issues regarding consent to clinical trials with pre-term or sick neonates: a systematic review (framework synthesis) of the analytical (theoretical/philosophical) research.

    Science.gov (United States)

    Megone, Christopher; Wilman, Eleanor; Oliver, Sandy; Duley, Lelia; Gyte, Gill; Wright, Judy

    2016-09-09

    Conducting clinical trials with pre-term or sick infants is important if care for this population is to be underpinned by sound evidence. Yet, approaching the parents of these infants at such a difficult time raises challenges to obtaining valid informed consent for such research. In this study, we asked, What light does the analytical literature cast on an ethically defensible approach to obtaining informed consent in perinatal clinical trials? In a systematic search, we identified 30 studies. We began our analysis by applying philosophical frameworks, which were then refined as concepts emerged from the analytical studies, to present a coherent picture of a broad literature. Between them, the studies addressed four themes. The first three were the ethical basis for parental informed consent for neonatal and/or perinatal research, the validity of parental consent in this context, and the range of possible options in methods for gaining consent. The last was the issue of risk and the possibility of a double-standard or asymmetry in the current approaches to the requirement for consent for research and consent for clinical treatment. In addressing these issues, the analysed studies showed that, whilst there are a variety of possible defences for seeking parental 'consent' to neonatal and/or perinatal clinical trials, these are all consistent with the strongly and widely held view that it is important that parents do give (or decline) consent for such research. So far as the method of obtaining consent is concerned, none of the existing consent processes reviewed by the research is satisfactory, and there are philosophical reasons for supposing that at least some parents will fail to give valid consent in a neonatal context. Furthermore, in giving parental 'consent' in a perinatal context, parents are authorising infant participation, not giving 'proxy consent'. Finally, there are reasons for giving weight to both parental 'consent' and the infant's best interests in

  1. Long-term pain prevalence and health-related quality of life outcomes for patients enrolled in a ketamine versus morphine for prehospital traumatic pain randomised controlled trial.

    Science.gov (United States)

    Jennings, Paul A; Cameron, Peter; Bernard, Stephen; Walker, Tony; Jolley, Damien; Fitzgerald, Mark; Masci, Kevin

    2014-10-01

    Improved early pain control may affect the longer-term prevalence of persistent pain. In a previous randomised, controlled trial, we found that the administration of ketamine on hospital arrival decreased pain scores to a greater extent than morphine alone in patients with prehospital traumatic pain. In this follow-up study, we sought to determine the prevalence of persistent pain and whether there were differences in patients who received ketamine or morphine. This study was a long-term follow-up study of the prehospital, prospective, randomised, controlled, open-label study comparing ketamine with morphine in patients with trauma and a verbal pain score of >5 after 5 mg intravenous morphine. Patients were followed-up by telephone 6-12 months after enrollment, and a questionnaire including the SF-36 (V.2) health-related quality of life survey and the Verbal Numerical Rating Scale for pain was administered. A total of 97/135 (72%) patients were able to be followed-up 6-12 months after enrollment between July 2008 and July 2010. Overall, 44/97 (45%) participants reported persistent pain related to their injury, with 3/97 (3%) reporting persistent severe pain. The prevalence of persistent pain was the same between study groups (22/50 (44%) for the ketamine group vs 22/47 (46%) for the morphine group). There was no difference in the SF-36 scores between study arms. There is a high incidence of persistent pain after traumatic injury, even in patients with relatively minor severity of injury. Although decreased pain scores at hospital arrival are achieved with ketamine compared with morphine, this difference does not affect the prevalence of persistent pain or health-related quality of life 6 months after injury. Further larger studies are required to confirm this finding. Australian and New Zealand Clinical Trials Registry (ACTRN12607000441415). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go

  2. A Prospective Trial of Intensity Modulated Radiation Therapy (IMRT) Incorporating a Simultaneous Integrated Boost for Prostate Cancer: Long-term Outcomes Compared With Standard Image Guided IMRT

    Energy Technology Data Exchange (ETDEWEB)

    Schild, Michael H. [Midwestern University, Glendale, Arizona (United States); Schild, Steven E., E-mail: sschild@mayo.edu [Department of Radiation Oncology, Mayo Clinic Hospital, Phoenix, Arizona (United States); Wong, William W.; Vora, Sujay A.; Keole, Sameer R.; Vargas, Carlos E.; Daniels, Thomas B.; Ezzell, Gary A. [Department of Radiation Oncology, Mayo Clinic Hospital, Phoenix, Arizona (United States); Nguyen, Ba D.; Roarke, Michael C. [Department of Radiology, Mayo Clinic, Scottsdale, Arizona (United States)

    2017-04-01

    Purpose: This report describes the long-term outcomes of a prospective trial of intensity modulated radiation therapy (IMRT), integrating a {sup 111}In capromab pendetide (ProstaScint) scan-directed simultaneous integrated boost (SIB) for localized prostate cancer. Methods and Materials: Seventy-one patients with T1N0M0 to T4N0M0 prostate cancer were enrolled, and their ProstaScint and pelvic computed tomography scans were coregistered for treatment planning. The entire prostate received 75.6 Gy in 42 fractions with IMRT, whereas regions of increased uptake on ProstaScint scans received 82 Gy as an SIB. Patients with intermediate- and high-risk disease also received 6 months and 12 months of adjuvant hormonal therapy, respectively. Results: The study enrolled 31 low-, 30 intermediate-, and 10 high-risk patients. The median follow-up was 120 months (range, 24-150 months). The 10-year biochemical control rates were 85% for the entire cohort and 84%, 84%, and 90% for patients with low-, intermediate-, and high-risk disease, respectively. The 10-year survival rate of the entire cohort was 69%. Pretreatment prostate-specific antigen level >10 ng/mL and boost volume of >10% of the prostate volume were significantly associated with poorer biochemical control and survival. The outcomes were compared with those of a cohort of 302 patients treated similarly but without the SIB and followed up for a median of 91 months (range, 6-138 months). The 5- and 10-year biochemical control rates were 86% and 61%, respectively, in patients without the SIB compared with 94% and 85%, respectively, in patients in this trial who received the SIB (P=.02). The cohort that received an SIB did not have increased toxicity. Conclusions: The described IMRT strategy, integrating multiple imaging modalities to administer 75.6 Gy to the entire prostate with a boost dose of 82 Gy, was feasible. The addition of the SIB was associated with greater biochemical control but not toxicity. Modern

  3. Long term effects of self-determination theory and motivational interviewing in a web-based physical activity intervention: randomized controlled trial.

    Science.gov (United States)

    Friederichs, Stijn A H; Oenema, Anke; Bolman, Catherine; Lechner, Lilian

    2015-08-18

    Our main objective in the current study was to evaluate the long-term effectiveness (12 months from baseline) of I Move (a web-based computer tailored physical activity intervention, based on self-determination theory and motivational interviewing). To this end, we compared I Move to a web-based computer tailored physical activity intervention based on traditional health behavior theories (Active Plus), and to a no-intervention control group. As a secondary objective, the present study aimed to identify participant characteristics that moderate the long term effects of I Move and Active Plus. A randomized controlled trial was conducted, comparing three research conditions: 1) the I Move condition, participants in this condition received I Move; 2) the Active Plus condition, participants in this condition received Active Plus; 3) the control condition; participants in this condition received no intervention and were placed on a waiting list. Main outcome measures were weekly minutes of moderate to vigorous physical activity and weekly days with minimal 30 min of physical activity. All measurements were taken by web-based questionnaires via the study website. Intervention effects were analyzed using multilevel linear regression analyses. At 12 months from baseline, I Move was found to be effective in increasing weekly minutes of moderate to vigorous physical activity (ES = .13), while Active Plus was not. In contrast, Active Plus was found to be effective in increasing weekly days with ≥ 30 min PA at 12 months (ES = .11), while I Move was not. No moderators of the effects of I Move were found. The results suggest that web-based computer tailored physical activity interventions might best include elements based on both self-determination theory/motivational interviewing and traditional health behavioral theories. To be more precise, it is arguable that the focus of the theoretical foundations, used in new web-based PA interventions should depend on the

  4. Very-low-carbohydrate ketogenic diet v. low-fat diet for long-term weight loss: a meta-analysis of randomised controlled trials.

    Science.gov (United States)

    Bueno, Nassib Bezerra; de Melo, Ingrid Sofia Vieira; de Oliveira, Suzana Lima; da Rocha Ataide, Terezinha

    2013-10-01

    The role of very-low-carbohydrate ketogenic diets (VLCKD) in the long-term management of obesity is not well established. The present meta-analysis aimed to investigate whether individuals assigned to a VLCKD (i.e. a diet with no more than 50 g carbohydrates/d) achieve better long-term body weight and cardiovascular risk factor management when compared with individuals assigned to a conventional low-fat diet (LFD; i.e. a restricted-energy diet with less than 30% of energy from fat). Through August 2012, MEDLINE, CENTRAL, ScienceDirect,Scopus, LILACS, SciELO, ClinicalTrials.gov and grey literature databases were searched, using no date or language restrictions, for randomised controlled trials that assigned adults to a VLCKD or a LFD, with 12 months or more of follow-up. The primary outcome was bodyweight. The secondary outcomes were TAG, HDL-cholesterol (HDL-C), LDL-cholesterol (LDL-C), systolic and diastolic blood pressure,glucose, insulin, HbA1c and C-reactive protein levels. A total of thirteen studies met the inclusion/exclusion criteria. In the overall analysis,five outcomes revealed significant results. Individuals assigned to a VLCKD showed decreased body weight (weighted mean difference 20·91 (95% CI 21·65, 20·17) kg, 1415 patients), TAG (weighted mean difference 20·18 (95% CI 20·27, 20·08) mmol/l, 1258 patients)and diastolic blood pressure (weighted mean difference 21·43 (95% CI 22·49, 20·37) mmHg, 1298 patients) while increased HDL-C(weighted mean difference 0·09 (95% CI 0·06, 0·12) mmol/l, 1257 patients) and LDL-C (weighted mean difference 0·12 (95% CI 0·04,0·2) mmol/l, 1255 patients). Individuals assigned to a VLCKD achieve a greater weight loss than those assigned to a LFD in the longterm; hence, a VLCKD may be an alternative tool against obesity.

  5. Short-term effects of the "Together at School" intervention program on children's socio-emotional skills: a cluster randomized controlled trial.

    Science.gov (United States)

    Kiviruusu, Olli; Björklund, Katja; Koskinen, Hanna-Leena; Liski, Antti; Lindblom, Jallu; Kuoppamäki, Heini; Alasuvanto, Paula; Ojala, Tiina; Samposalo, Hanna; Harmes, Nina; Hemminki, Elina; Punamäki, Raija-Leena; Sund, Reijo; Santalahti, Päivi

    2016-05-26

    Together at School is a universal intervention program designed to promote socio-emotional skills among primary-school children. It is based on a whole school approach, and implemented in school classes by teachers. The aim of the present study is to examine the short-term effects of the intervention program in improving socio-emotional skills and reducing psychological problems among boys and girls. We also examine whether these effects depend on grade level (Grades 1 to 3) and intervention dosage. This cluster randomized controlled trial design included 79 Finnish primary schools (40 intervention and 39 control) with 3 704 children. The outcome measures were the Strengths and Difficulties Questionnaire (SDQ) and the Multisource Assessment of Social Competence Scale (MASCS) with teachers as raters. The intervention dosage was indicated by the frequencies six central tools were used by the teachers. The data was collected at baseline and 6 months later. Intervention effects were analyzed using multilevel modeling. When analyzed across all grades no intervention effect was observed in improving children's socio-emotional skills or in reducing their psychological problems at 6-month follow-up. Among third (compared to first) graders the intervention decreased psychological problems. Stratified analyses by gender showed that this effect was significant only among boys and that among them the intervention also improved third graders' cooperation skills. Among girls the intervention effects were not moderated by grade. Implementing the intervention with intended intensity (i.e. a high enough dosage) had a significant positive effect on cooperation skills. When analyzed separately among genders, this effect was significant only in girls. These first, short-term results of the Together at School intervention program did not show any main effects on children's socio-emotional skills or psychological problems. This lack of effects may be due to the relatively short follow

  6. Proof-of-concept, randomized, controlled clinical trial of Bacillus-Calmette-Guerin for treatment of long-term type 1 diabetes.

    Directory of Open Access Journals (Sweden)

    Denise L Faustman

    Full Text Available No targeted immunotherapies reverse type 1 diabetes in humans. However, in a rodent model of type 1 diabetes, Bacillus Calmette-Guerin (BCG reverses disease by restoring insulin secretion. Specifically, it stimulates innate immunity by inducing the host to produce tumor necrosis factor (TNF, which, in turn, kills disease-causing autoimmune cells and restores pancreatic beta-cell function through regeneration.Translating these findings to humans, we administered BCG, a generic vaccine, in a proof-of-principle, double-blind, placebo-controlled trial of adults with long-term type 1 diabetes (mean: 15.3 years at one clinical center in North America. Six subjects were randomly assigned to BCG or placebo and compared to self, healthy paired controls (n = 6 or reference subjects with (n = 57 or without (n = 16 type 1 diabetes, depending upon the outcome measure. We monitored weekly blood samples for 20 weeks for insulin-autoreactive T cells, regulatory T cells (Tregs, glutamic acid decarboxylase (GAD and other autoantibodies, and C-peptide, a marker of insulin secretion. BCG-treated patients and one placebo-treated patient who, after enrollment, unexpectedly developed acute Epstein-Barr virus infection, a known TNF inducer, exclusively showed increases in dead insulin-autoreactive T cells and induction of Tregs. C-peptide levels (pmol/L significantly rose transiently in two BCG-treated subjects (means: 3.49 pmol/L [95% CI 2.95-3.8], 2.57 [95% CI 1.65-3.49] and the EBV-infected subject (3.16 [95% CI 2.54-3.69] vs.1.65 [95% CI 1.55-3.2] in reference diabetic subjects. BCG-treated subjects each had more than 50% of their C-peptide values above the 95(th percentile of the reference subjects. The EBV-infected subject had 18% of C-peptide values above this level.We conclude that BCG treatment or EBV infection transiently modified the autoimmunity that underlies type 1 diabetes by stimulating the host innate immune response. This suggests that BCG or other

  7. Long-term results of 2 adjuvant trials reveal differences in chemosensitivity and the pattern of metastases between colon cancer and rectal cancer.

    Science.gov (United States)

    Kornmann, Marko; Staib, Ludger; Wiegel, Thomas; Kron, Martina; Henne-Bruns, Doris; Link, Karl-Heinrich; Formentini, Andrea

    2013-03-01

    Two identical randomized controlled trials designed to optimize adjuvant treatment of colon cancer (CC) (n =855) and rectal cancer (RC) (n = 796) were performed. Long-term evaluation confirmed that the addition of folinic acid (FA) to 5-fluorouracil (5-FU) improved 7-year overall survival (OS) in CC but not in RC and revealed different patterns of recurrence in patients with CC and those with RC. Our aim was to compare long-term results of adjuvant treatment of colon cancer (CC) and rectal cancer (RC). Adjuvant chemotherapy of CC improved overall survival (OS), whereas that of RC remained at the level achieved by 5-fluorouracil (5-FU). We separately conducted 2 identically designed adjuvant trials in CC and RC. Patients were assigned to adjuvant chemotherapy with 5-FU alone, 5-FU + folinic acid (FA), or 5-FU + interferon-alfa. The first study enrolled patients with stage IIb/III CC, and the second study enrolled patients with stage II/III RC. All patients with RC received postoperative irradiation. Median follow-up for all patients with CC (n = 855) and RC (n = 796) was 4.9 years. The pattern and frequency of recurrence differed significantly, especially lung metastases, which occurred more frequently in RC (12.7%) than in CC (7.3%; P < .001). Seven-year OS rates for 5-FU, 5-FU + FA, and 5-FU + IFN-alfa were 54.1% (95% confidence interval [CI], 46.5-61.0), 66.8% (95% CI, 59.4-73.1), and 56.7% (95% CI, 49.3-63.4) in CC and 50.6% (95% CI, 43.0-57.7), 56.3% (95% CI, 49.4-62.7), and 54.8% (95% CI, 46.7-62.2) in RC, respectively. A subgroup analysis pointed to a reduced local recurrence (LR) rate and an increased OS by the addition of FA in stage II RC (n = 271) but not in stage III RC (n = 525). FA increased 7-year OS by 12.7 percentage points in CC but was not effective in RC. Based on these results and the pattern of metastases, our results suggest that the chemosensitivity of CC and RC may be different. Strategies different from those used in CC may be successful to

  8. Effects of neurofeedback on the short-term memory and continuous attention of patients with moderate traumatic brain injury: A preliminary randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Reza Rostami

    2017-10-01

    Full Text Available Purpose: There are some studies which showed neurofeedback therapy (NFT can be effective in clients with traumatic brain injury (TBI history. However, randomized controlled clinical trials are still needed for evaluation of this treatment as a standard option. This preliminary study was aimed to evaluate the effect of NFT on continuous attention (CA and short-term memory (STM of clients with moderate TBI using a randomized controlled clinical trial (RCT. Methods: In this preliminary RCT, seventeen eligible patients with moderate TBI were randomly allocated in two intervention and control groups. All the patients were evaluated for CA and STM using the visual continuous attention test and Wechsler memory scale-4th edition (WMS-IV test, respectively, both at the time of inclusion to the project and four weeks later. The intervention group participated in 20 sessions of NFT through the first four weeks. Conversely, the control group participated in the same NF sessions from the fifth week to eighth week of the project. Results: Eight subjects in the intervention group and five subjects in the control group completed the study. The mean and standard deviation of participants' age were (26.75 ± 15.16 years and (27.60 ± 8.17 years in experiment and control groups, respectively. All of the subjects were male. No significant improvement was observed in any variables of the visual continuous attention test and WMS-IV test between two groups (p ≥ 0.05. Conclusion: Based on our literature review, it seems that our study is the only study performed on the effect of NFT on TBI patients with control group. NFT has no effect on CA and STM in patients with moderate TBI. More RCTs with large sample sizes, more sessions of treatment, longer time of follow-up and different protocols are recommended. Keywords: Neurofeedback, Brain injuries, Attention, Short-term memory

  9. Trajectories of change and long-term outcomes in a randomised controlled trial of internet-based insomnia treatment to prevent depression.

    Science.gov (United States)

    Batterham, Philip J; Christensen, Helen; Mackinnon, Andrew J; Gosling, John A; Thorndike, Frances P; Ritterband, Lee M; Glozier, Nick; Griffiths, Kathleen M

    2017-09-01

    Insomnia treatment using an internet-based cognitive-behavioural therapy for insomnia (CBT-I) program reduces depression symptoms, anxiety symptoms and suicidal ideation. However, the speed, longevity and consistency of these effects are unknown. To test the following: whether the efficacy of online CBT-I was sustained over 18 months; how rapidly the effects of CBT-I emerged; evidence for distinct trajectories of change in depressive symptoms; and predictors of these trajectories. A randomised controlled trial compared the 6-week Sleep Healthy Using the Internet (SHUTi) CBT-I program to an attention control program. Adults ( N =1149) with clinical insomnia and subclinical depression symptoms were recruited online from the Australian community. Depression, anxiety and insomnia decreased significantly by week 4 of the intervention period and remained significantly lower relative to control for >18 months (between-group Cohen's d =0.63, 0.47, 0.55, respectively, at 18 months). Effects on suicidal ideation were only short term. Two depression trajectories were identified using growth mixture models: improving (95%) and stable/deteriorating (5%) symptoms. More severe baseline depression, younger age and limited comfort with the internet were associated with reduced odds of improvement. Online CBT-I produced rapid and long-term symptom reduction in people with subclinical depressive symptoms, although the initial effect on suicidal ideation was not sustained. P.J.B. has received grants from the National Health and Medical Research Council (NHMRC) during the conduct of the study. H.C. has received grants from the NHMRC and the Australian Research Council during the conduct of the study. L.M.R. receives research funding from the National Institutes of Health (NIH) that, in part, focuses on insomnia. F.P.T. and L.M.R. have equity ownership in BeHealth Solutions (Charlottesville, VA, USA), a company that develops and makes available products related to the research reported

  10. Adult height after long-term, continuous growth hormone (GH) treatment in short children born small for gestational age: results of a randomized, double-blind, dose-response GH trial

    NARCIS (Netherlands)

    Y. van Pareren; M. Houdijk; M. Jansen (Maarten); M. Reeser; P.G.H. Mulder (Paul); A.C.S. Hokken-Koelega (Anita)

    2003-01-01

    textabstractThe GH dose-response effect of long-term continuous GH treatment on adult height (AH) was evaluated in 54 short children born small for gestational age (SGA) who were participating in a randomized, double-blind, dose-response trial. Patients were randomly and blindly

  11. Long-Term Outcome and Quality of Life of Patients With Endometrial Carcinoma Treated With or Without Pelvic Radiotherapy in the Post Operative Radiation Therapy in Endometrial Carcinoma 1 (PORTEC-1) Trial

    NARCIS (Netherlands)

    Nout, Remi A.; van de Poll-Franse, Lonneke V.; Lybeert, Marnix L. M.; Warlam-Rodenhuis, Carla C.; Jobsen, Jan J.; Mens, Jan Willem M.; Lutgens, Ludy C. H. W.; Pras, Betty; van Putten, Wim L. J.; Creutzberg, Carien L.

    2011-01-01

    Purpose To determine the long-term outcome and health-related quality of life (HRQL) of patients with endometrial carcinoma (EC) treated with or without pelvic radiotherapy in the Post Operative Radiation Therapy in Endometrial Carcinoma 1 (PORTEC-1) trial. Patients and Methods Between 1990 and

  12. Short- and long-term effects of real-time medication monitoring with short message service (SMS) reminders for missed doses on the refill adherence of people with Type 2 diabetes: evidence from a randomised controlled trial.

    NARCIS (Netherlands)

    Vervloet, M.; Dijk, L. van; Bakker, D.H. de; Souverein, P.C.; Santen-Reestman, J.; Vlijmen, B. van; Aarle, M.C.W. van; Hoek, L.S. van der; Bouvy, M.L.

    2014-01-01

    Aims: To investigate short- and long-term effects of real-time monitoring medication use combined with short message service (SMS) reminders for missed doses on refill adherence to oral anti-diabetic medication. Methods: A randomized controlled trial with two intervention groups and one control

  13. Effects of hybrid cycling versus handcycling on wheelchair-specific fitness and physical activity in people with long-term spinal cord injury : a 16-week randomized controlled trial

    NARCIS (Netherlands)

    Bakkum, A. J. T.; de Groot, S.; Stolwijk-Swuste, J. M.; van Kuppevelt, D. J.; van der Woude, L. H. V.; Janssen, T. W. J.

    Study design: This is an open randomized controlled trial. Objective: The objective of this study was to investigate the effects of a 16-week hybrid cycle versus handcycle exercise program on fitness and physical activity in inactive people with long-term spinal cord injury (SCI). Setting: The study

  14. Effects of hybrid cycling versus handcycling on wheelchair-specific fitness and physical activity in people with long-term spinal cord injury: a 16-week randomized controlled trial

    NARCIS (Netherlands)

    Bakkum, A.J.T.; de Groot, S.; Stolwijk-Swuste, J.M.; van Kuppevelt, D.J.; van der Woude, L.H.V.; Janssen, T.W.J.

    2015-01-01

    Study design:This is an open randomized controlled trial.Objective:The objective of this study was to investigate the effects of a 16-week hybrid cycle versus handcycle exercise program on fitness and physical activity in inactive people with long-term spinal cord injury (SCI).Setting:The study was

  15. Strengthened General Self-Efficacy with Multidisciplinary Vocational Rehabilitation in Women on Long-Term Sick Leave: A Randomised Controlled Trial.

    Science.gov (United States)

    Andersén, Åsa; Larsson, Kjerstin; Lytsy, Per; Berglund, Erik; Kristiansson, Per; Anderzén, Ingrid

    2018-01-09

    Purpose To investigate the effects of two vocational rehabilitation interventions on self-efficacy, for women on long-term sick leave ≥ 1 year due to chronic pain and/or mental illness. Methods This study uses data from a randomised controlled trial consisting of two phases and comprising 401 women on long-term sick leave. They were allocated to either (1) a multidisciplinary team assessment and multimodal intervention (TEAM), (2) acceptance and commitment therapy (ACT), or (3) control group. Data were collected through repeated measurements from self-reported questionnaires before intervention, 6 and 12 months later and registry data. Data from measurements of general self-efficacy, sociodemographics, anxiety and depression were analysed with linear regression analyses. Results During the intervention period, the women in the TEAM group's self-efficacy mean increased from 2.29 to 2.74. The adjusted linear regression model, which included group allocation, sociodemographics, self-efficacy pre-treatment, anxiety and depression showed increased self-efficacy for those in the TEAM intervention at 12 months (B = 0.25, 95% CI 0.10-0.41). ACT intervention had no effect on self-efficacy at 12 months (B = 0.02, 95% CI - 0.16 to 0.19). The results in the adjusted model also showed that higher self-efficacy at pre-treatment was associated with a higher level of self-efficacy at 12 months (B = 0.68, 95% CI 0.54-0.81). Conclusion A multidisciplinary team assessment and multimodal intervention increased self-efficacy in women on sick leave for an extremely long time (mean 7.8 years) who had a low mean level of self-efficacy prior to inclusion. Thus, self-efficacy needs to be addressed in vocational rehabilitation.

  16. Comparative short-term effects of two thoracic spinal manipulation techniques in subjects with chronic mechanical neck pain: a randomized controlled trial.

    Science.gov (United States)

    Casanova-Méndez, Amaloha; Oliva-Pascual-Vaca, Angel; Rodriguez-Blanco, Cleofás; Heredia-Rizo, Alberto Marcos; Gogorza-Arroitaonandia, Kristobal; Almazán-Campos, Ginés

    2014-08-01

    Spinal Manipulation (SM) has been purported to decrease pain and improve function in subjects with non-specific neck pain. Previous research has investigated which individuals with non-specific neck pain will be more likely to benefit from SM. It has not yet been proven whether or not the effectiveness of thoracic SM depends on the specific technique being used. This double-blind randomized trial has compared the short-term effects of two thoracic SM maneuvers in subjects with chronic non-specific neck pain. Sixty participants were distributed randomly into two groups. One group received the Dog technique (n = 30), with the subject in supine position, and the other group underwent the Toggle-Recoil technique (n = 30), with the participant lying prone, T4 being the targeted area in both cases. Evaluations were made of self-reported neck pain (Visual Analogue Scale); neck mobility (Cervical Range of Motion); and pressure pain threshold at the cervical and thoracic levels (C4 and T4 spinous process) and over the site described for location of tense bands of the upper trapezius muscle. Measurements were taken before intervention, immediately afterward, and 20 min later. Both maneuvers improved neck mobility and mechanosensitivity and reduced pain in the short term. No major or clinical differences were found between the groups. In the between-groups comparison slightly better results were observed in the Toggle-Recoil group only for cervical extension (p = 0.009), right lateral flexion (p = 0.004) and left rotation (p < 0.05). Copyright © 2014 Elsevier Ltd. All rights reserved.

  17. Preoperative chemotherapy versus chemoradiotherapy in locally advanced adenocarcinomas of the oesophagogastric junction (POET): Long-term results of a controlled randomised trial.

    Science.gov (United States)

    Stahl, Michael; Walz, Martin K; Riera-Knorrenschild, Jorge; Stuschke, Martin; Sandermann, Andreas; Bitzer, Michael; Wilke, Hansjochen; Budach, Wilfried

    2017-08-01

    Results of the PreOperative therapy in Esophagogastric adenocarcinoma Trial (POET) showed some benefits when including radiotherapy into the preoperative treatment. This article is reporting long-term results of this phase III study. Patients with locally advanced adenocarcinomas of the oesophagogastric junction (Siewert types I-III) were eligible. Randomisation was done to chemotherapy (group A) or induction chemotherapy and chemoradiotherapy (CRT; group B) followed by surgery. The primary end-point of the study was overall survival at 3 years. The study was closed early after 119 patients having been randomised and were eligible. Local progression-free survival after tumour resection was significantly improved by CRT (hazard ratio [HR] 0.37; 0.16-0.85, p = value 0.01) and 20 versus 12 patients were free of local tumour progression at 5 years (p = 0.03). Although the rate of postoperative in-hospital mortality was somewhat higher with CRT (10.2% versus 3.8%, p = 0.26), more patients were alive at 3 and 5 years after CRT (46.7% and 39.5%) compared with chemotherapy (26.1% and 24.4%). Thus, overall survival showed a trend in favour of preoperative CRT (HR 0.65, 95% confidence interval [CI] 0.42-1.01, p = 0.055). Although the primary end-point overall survival of the study was not met, our long-term follow-up data suggest a benefit in local progression-free survival when radiotherapy was added to preoperative chemotherapy in patients with locally advanced adenocarcinoma of the oesophagogastric junction. Copyright © 2017 Elsevier Ltd. All rights reserved.

  18. Heller myotomy versus Heller myotomy with Dor fundoplication for achalasia: long-term symptomatic follow-up of a prospective randomized controlled trial.

    Science.gov (United States)

    Kummerow Broman, Kristy; Phillips, Sharon E; Faqih, Adil; Kaiser, Joan; Pierce, Richard A; Poulose, Benjamin K; Richards, William O; Sharp, Kenneth W; Holzman, Michael D

    2018-04-01

    Our prior randomized controlled trial of Heller myotomy alone versus Heller plus Dor fundoplication for achalasia from 2000 to 2004 demonstrated comparable postoperative resolution of dysphagia but less gastroesophageal reflux after Heller plus Dor. Patient-reported outcomes are needed to determine whether the findings are sustained long-term. We actively engaged participants from the prior randomized cohort, making up to six contact attempts per person using telephone, mail, and electronic messaging. We collected patient-reported measures of dysphagia and gastroesophageal reflux using the Dysphagia Score and the Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) instrument. Patient-reported re-interventions for dysphagia were verified by obtaining longitudinal medical records. Among living participants, 27/41 (66%) were contacted and all completed the follow-up study at a mean of 11.8 years postoperatively. Median Dysphagia Scores and GERD-HRQL scores were slightly worse for Heller than Heller plus Dor but were not statistically different (6 vs 3, p = 0.08 for dysphagia, 15 vs 13, p = 0.25 for reflux). Five patients in the Heller group and 6 in Heller plus Dor underwent re-intervention for dysphagia with most occurring more than five years postoperatively. One patient in each group underwent redo Heller myotomy and subsequent esophagectomy. Nearly all patients (96%) would undergo operation again. Long-term patient-reported outcomes after Heller alone and Heller plus Dor for achalasia are comparable, providing support for either procedure.

  19. Long-term mother and child mental health effects of a population-based infant sleep intervention: cluster-randomized, controlled trial.

    Science.gov (United States)

    Hiscock, Harriet; Bayer, Jordana K; Hampton, Anne; Ukoumunne, Obioha C; Wake, Melissa

    2008-09-01

    Maternal depression is an established risk for adverse child development. Two thirds of clinically significant depressive symptoms occur in mothers reporting an infant sleep problem. We aimed to determine the long-term effects of a behavioral intervention for infant sleep problems on maternal depression and parenting style, as well as on child mental health and sleep, when the children reached 2 years of age. We conducted a cluster-randomized trial in well-child centers across 6 government areas of Melbourne, Australia. Participants included 328 mothers reporting an infant sleep problem at 7 months, drawn from a population sample (N = 739) recruited at 4 months. We compared the usual well-child care (n = 154) versus a brief behavior-modification program designed to improve infant sleep (n = 174) delivered by well-child nurses at ages 8 to 10 months and measured maternal depression symptoms (Edinburgh Postnatal Depression Scale); parenting practices (Parent Behavior Checklist); child mental health (Child Behavior Checklist); and maternal report of a sleep problem (yes or no). At 2 years, mothers in the intervention group were less likely than control mothers to report clinical depression symptoms: 15.4% vs 26.4% (Edinburgh Postnatal Depression Scale community cut point) and 4.2% vs 13.2% (Edinburgh Postnatal Depression Scale clinical cut point). Neither parenting style nor child mental health differed markedly between the intervention and control groups. A total of 27.3% of children in the intervention group versus 32.6% of control children had a sleep problem. The sleep intervention in infancy resulted in sustained positive effects on maternal depression symptoms and found no evidence of longer-term adverse effects on either mothers' parenting practices or children's mental health. This intervention demonstrated the capacity of a functioning primary care system to deliver effective, universally offered secondary prevention.

  20. Comparative randomized open-label trial on efficacy and safety of Persen® and Persen® Night herbal extracts in patients with short-term insomnia

    Directory of Open Access Journals (Sweden)

    A. P. Rachin

    2016-01-01

    Full Text Available Herbal sedatives serve an alternative to antipsychotics and hypnotics aimed to alleviate symptoms of anxious disorders and insomnia. Valeriana officinalis L., Mentha piperita L. and Melissa officinalis are most widely used in neurology as sedatives of herbal origin. We present the results of a randomized open-label trial on efficiency and safety of Persen® and Persen® Night containing extracts of the above mentioned plants in patients with short-term insomnia. The study consisted of 60 subjects of 18–65 y.o. (mean 42.4 ± 6.9 y.o. with short-term insomnia due to adjustment disorder or mixed anxiety-depressive disorders: 30 of them got Persen® 2 tablets a day and 30 – Persen® Night, 1 capsule 30–60 min before sleep during 4 weeks. The majority (76.5 % of patients referred the onset of insomnia with psychosocial traumatic stressor. Persen® Night’s main action was found on superficial sleep, number of night awakenings, sleep onset rate. At the end of the therapy with this substance 39.7 % of patients fell asleep in 10–15 min, and 92.2 % – in 30 min, accordingly, while for Persen® at 17.4 and 80.3 % accordingly (р < 0.05. In the meantime Persen® decreased the bad sleep perception at awakening and day somnolence, mostly attributed to the mood improvement and decrease of anxiety. Levels of efficacy and safety for both substances were significant, allowing to regard them as potential phytotherapeutic agent in the treatment of insomnia and mixed anxiety-depressive disorders.

  1. Long-term effects of high-intensity interval training in heart transplant recipients: A 5-year follow-up study of a randomized controlled trial.

    Science.gov (United States)

    Yardley, Marianne; Gullestad, Lars; Bendz, Bjørn; Bjørkelund, Elisabeth; Rolid, Katrine; Arora, Satish; Nytrøen, Kari

    2017-01-01

    Previous studies have demonstrated that high-intensity interval training (HIT) is superior to moderate-continuous exercise in general and in cardiovascular diseases. Recently, we also found HIT safe and efficient after heart transplantation (HTx). This study reports the 5-year long-term effects. Forty-one HTx patients who had completed the previous 12-month randomized controlled trial, comparing HIT intervention with usual care, were eligible. In particular, we measured VO 2peak , muscular capacity, intravascular ultrasound, and questionnaires measuring physical and mental health. The baseline mean±SD values were as follows: age; 49.1±16.5 years, men; 68%, time since HTx: 4.1±2.2 years. Within the HIT group, initial VO 2peak increased significantly from 27.7±5.7 to 31.2±5.3 mL/kg/min. However, during the next 4 years, VO 2peak decreased to 26.0±6.2 mL/kg/min. The control group showed slightly decreasing VO 2peak values during the entire 5-year period. The HIT group reported significantly less anxiety symptoms, but there were no long-term differences in VO 2peak , muscular capacity, or cardiac allograft vasculopathy between the groups. The similar VO 2peak values correspond to our findings of similar everyday activity. Our findings suggest that intermittent periods of HIT may be necessary to maintain the initial benefits gained from the intervention. However, HIT probably reduces the burden of anxiety, which is a frequent health issue following HTx. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  2. Secondary Prevention of Chronic PTSD by Early and Short-Term Administration of Escitalopram: A Prospective Randomized, Placebo-Controlled, Double-Blind Trial.

    Science.gov (United States)

    Zohar, Joseph; Fostick, Leah; Juven-Wetzler, Alzabeta; Kaplan, Zeev; Shalev, Hadar; Schreiber, Gavriel; Miroshnik, Natalie; Shalev, Arieh Y; Stein, Dan J; Seedat, Soraya; Suliman, Sharain; Klein, Ehud

    Prospective studies have not identified a viable pharmacologic strategy for secondary prevention of posttraumatic stress disorder (PTSD). The authors examined whether preventive intervention via early and short-term administration of a selective serotonin reuptake in