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Sample records for n-ma randomised controlled

  1. The role of treatment timing and mode of stimulation in the treatment of primary dysmenorrhea with acupuncture: An exploratory randomised controlled trial

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    Dahlen, Hannah G.; Zhu, Xiaoshu; Farquhar, Cindy; Smith, Caroline A.

    2017-01-01

    Objectives We examined the effect of changing treatment timing and the use of manual, electro acupuncture on the symptoms of primary dysmenorrhea. Methods A randomised controlled trial was performed with four arms, low frequency manual acupuncture (LF-MA), high frequency manual acupuncture (HF-MA), low frequency electro acupuncture (LF-EA) and high frequency electro acupuncture (HF-EA). A manualised trial protocol was used to allow differentiation and individualized treatment over three months. A total of 74 women were randomly assigned to one of the four groups (LF-MA n = 19, HF-MA n = 18, LF-EA n = 18, HF-EA n = 19). Twelve treatments were performed over three menstrual cycles, either once per week (LF groups) or three times in the week prior to menses (HF groups). All groups received a treatment in the first 48 hours of menses. The primary outcome was the reduction in peak menstrual pain at 12 months from trial entry. Results During the treatment period and nine month follow-up all groups showed statistically significant (p 0.05). Health related quality of life increased significantly in six domains in groups having high frequency of treatment compared to two domains in low frequency groups. Manual acupuncture groups required less analgesic medication than electro-acupuncture groups (p = 0.02). HF-MA was most effective in reducing secondary menstrual symptoms compared to both–EA groups (p<0.05). Conclusion Acupuncture treatment reduced menstrual pain intensity and duration after three months of treatment and this was sustained for up to one year after trial entry. The effect of changing mode of stimulation or frequency of treatment on menstrual pain was not significant. This may be due to a lack of power. The role of acupuncture stimulation on menstrual pain needs to be investigated in appropriately powered randomised controlled trials. PMID:28700680

  2. The role of treatment timing and mode of stimulation in the treatment of primary dysmenorrhea with acupuncture: An exploratory randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Mike Armour

    Full Text Available We examined the effect of changing treatment timing and the use of manual, electro acupuncture on the symptoms of primary dysmenorrhea.A randomised controlled trial was performed with four arms, low frequency manual acupuncture (LF-MA, high frequency manual acupuncture (HF-MA, low frequency electro acupuncture (LF-EA and high frequency electro acupuncture (HF-EA. A manualised trial protocol was used to allow differentiation and individualized treatment over three months. A total of 74 women were randomly assigned to one of the four groups (LF-MA n = 19, HF-MA n = 18, LF-EA n = 18, HF-EA n = 19. Twelve treatments were performed over three menstrual cycles, either once per week (LF groups or three times in the week prior to menses (HF groups. All groups received a treatment in the first 48 hours of menses. The primary outcome was the reduction in peak menstrual pain at 12 months from trial entry.During the treatment period and nine month follow-up all groups showed statistically significant (p 0.05. Health related quality of life increased significantly in six domains in groups having high frequency of treatment compared to two domains in low frequency groups. Manual acupuncture groups required less analgesic medication than electro-acupuncture groups (p = 0.02. HF-MA was most effective in reducing secondary menstrual symptoms compared to both-EA groups (p<0.05.Acupuncture treatment reduced menstrual pain intensity and duration after three months of treatment and this was sustained for up to one year after trial entry. The effect of changing mode of stimulation or frequency of treatment on menstrual pain was not significant. This may be due to a lack of power. The role of acupuncture stimulation on menstrual pain needs to be investigated in appropriately powered randomised controlled trials.

  3. The role of treatment timing and mode of stimulation in the treatment of primary dysmenorrhea with acupuncture: An exploratory randomised controlled trial.

    Science.gov (United States)

    Armour, Mike; Dahlen, Hannah G; Zhu, Xiaoshu; Farquhar, Cindy; Smith, Caroline A

    2017-01-01

    We examined the effect of changing treatment timing and the use of manual, electro acupuncture on the symptoms of primary dysmenorrhea. A randomised controlled trial was performed with four arms, low frequency manual acupuncture (LF-MA), high frequency manual acupuncture (HF-MA), low frequency electro acupuncture (LF-EA) and high frequency electro acupuncture (HF-EA). A manualised trial protocol was used to allow differentiation and individualized treatment over three months. A total of 74 women were randomly assigned to one of the four groups (LF-MA n = 19, HF-MA n = 18, LF-EA n = 18, HF-EA n = 19). Twelve treatments were performed over three menstrual cycles, either once per week (LF groups) or three times in the week prior to menses (HF groups). All groups received a treatment in the first 48 hours of menses. The primary outcome was the reduction in peak menstrual pain at 12 months from trial entry. During the treatment period and nine month follow-up all groups showed statistically significant (p 0.05). Health related quality of life increased significantly in six domains in groups having high frequency of treatment compared to two domains in low frequency groups. Manual acupuncture groups required less analgesic medication than electro-acupuncture groups (p = 0.02). HF-MA was most effective in reducing secondary menstrual symptoms compared to both-EA groups (p<0.05). Acupuncture treatment reduced menstrual pain intensity and duration after three months of treatment and this was sustained for up to one year after trial entry. The effect of changing mode of stimulation or frequency of treatment on menstrual pain was not significant. This may be due to a lack of power. The role of acupuncture stimulation on menstrual pain needs to be investigated in appropriately powered randomised controlled trials.

  4. y comercialización de maíz de Sinaloa

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    José Alberto García Salazar

    2006-01-01

    Full Text Available La política comercial instrumentada por el Gobierno de México dirigida al mercado de maíz se ha caracterizado por la autorización de importaciones libres de arancel superiores a la cuota establecida en el Tratado de Libre Comercio de América del Norte. Con el objetivo de analizar cómo esta política podría afectar la comercialización de la producción de maíz de Sinaloa, se usó un modelo de distribución de la producción del grano que incorpora características espaciales e intertemporales. Los resultados indican que si el consumo nacional real de maíz fuera menor en 10%, respecto al consumo nacional aparente, las mayores importaciones determinarían que 954 mil toneladas de la producción de la entidad no pudrían comercializarse. Debido a que esta situación resta competitividad al productor de maíz, puesto que la producción no comercializada tiene que almacenarse, los productores sinaloenses deberán estar pendientes y vigilar las decisiones del Gobierno en materia de cupos de importación de maíz.

  5. Evaluación de abonos verdes en el sistema de producción maíz-leguminosas

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    Prager M. Martin

    1989-06-01

    Full Text Available En la primera parte del ensayo, se estudió el comportamiento del peso de nódulos, peso fresco y peso seco de tres leguminosas (Crotalaria, Canavalia y Guandul a utilizar como abonos verdes y su efecto sobre sistemas de producción maíz-leguminosas (maíz-caupí, maíz-soya, maíz-frijol. Las variables consideradas (rendimiento, rendimiento equivalente de maíz, ingreso neto y tasa de retorno marginal mostraron el efecto positivo de esta práctica sobre esta forma de producción obteniéndose mejor respuesta de el sistema maíz-caupí. De los abonos verdes la crotalaria presentó el mejor efecto sobre los sistemas de producción. En la segunda parte del trabajo, se utilizó el sistema de producción de mejor comportamiento introduciendo al factor abono verde algunas modalidades de tratamiento, entre ellas efecto residual, adición de una segunda incorporación de los tres abonos verdes y efecto residual más la adición de abono químico. La consideración de las mismas variables usadas en la primera parte mostro mejores valores por la segunda incorporación de abono verde y la adición de abono químico en su orden, el efecto residual de los abonos permite obtener rendimientos superiores a los alcanzados por el testigo.This research was divided in two parts. The first studies the behavior of three legumes (Crotalaria, Canavalia and Cajanus as green manure, measuring weight nodules, green weight matter and dry weight matter of them, so measured the effect on three production systems: Maize- cowpea, Maize- soybean and Maize-bean. The indicators (yield, equivalent maize yields, net income and marginal return rate showed positive effect of green manure on this production systems too maize-cowpea system showed the best yields; Crotalaria was ,the best green manure. In second experimental stage maize- cowpea system was evaluated, using the same indicators and introducing new treatments related to green manure: its residual effects, addicional

  6. Pfister y la Hibridación del Maíz

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    Kent. George

    1940-03-01

    Full Text Available En la Facultad Nacional de Agronomía, se están haciendo actualmente los trabajos de aclimatación del "maíz hibrido Pfister". Cuando el suscrito tuvo conocimiento del "maíz híbrido" obtenido como fruto de una experimentación de más de 20 años llevada a cabo en Illinois por el señor Pfister, se interesó vivamente en traer unas semillas a Colombia para intentar el proceso de aclimatación de las mejores variedades. A pesar de una larga correspondencia con el señor Pfister desde hace dos años, no nos fue posible lograr nuestro objeto. Durante la última visita del suscrito a ese país, obtuve, como una merced personal, una muy pequeña cantidad de las ocho mejores variedades de maíz híbrido, y al efecto, a la presente le estoy incluyendo a usted esas semillas de maíz sin otra retribución para nosotros, que el de hacer las siembras, observaciones y experimentaciones con todo el cuidado de que usted es capaz, y darnos cuenta oportuna de los resultados obtenidos con cada una de las variedades. Cada talego está marcado con el número de la variedad y no está por demás rogar a usted de la manera más encarecida llevar a efecto este trabajo con el mayor cuidado e interés para corresponder por lo menos al que hemos tenido nosotros en proporcionarle las dichas semillas. A pesar de que en Estados Unidos han hecho una súper selección de maíz en los últimos 50 años, las semillas seleccionadas han; quedado superadas por el maíz "Híbrido Pfister" con rendimientos de más de un 60%. Como nosotros no hemos hecho nada en selección de maíz, nuestro trabajo se puede limitar a un proceso de "aclimatación", que si logramos, tendríamos ganados muchos años de trabajo.

  7. La evolución del mejoramiento del maíz

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    Arriaga, Héctor O.

    1987-01-01

    La producción e importancia primordial del maíz como grano forrajero, hacen que se sindique al maíz como el cereal más representativo de los países desarrollados. Por su producción mundial, ocupa el 2° lugar, después del trigo, con 481 millones de toneladas, de las que el 64 % corresponde a los países desarrollados. Estos son, a su vez, los principales exportadores y consumidores por ser también los más importantes importadores, con un 71 % de las 68 millones de toneladas de maíz que se...

  8. Randomised controlled trial of biofeedback training in persistent encopresis with anismus.

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    Nolan, T; Catto-Smith, T; Coffey, C; Wells, J

    1998-08-01

    Paradoxical external anal sphincter contraction during attempted defecation (anismus) is thought to be an important contributor to chronic faecal retention and encopresis in children. Biofeedback training can be used to teach children to abolish this abnormal contraction. A randomised controlled trial in medical treatment resistant and/or treatment dependent children with anismus using surface electromyographic (EMG) biofeedback training to determine whether such training produces sustained faecal continence. Up to four sessions of biofeedback training were conducted at weekly intervals for each patient. Anorectal manometry was performed before randomisation and six months later. Parents of patients completed the "child behaviour checklist" (CBCL) before randomisation and at follow up. Sixty eight children underwent anorectal manometry and EMG. Of these, 29 had anismus (ages 4-14 years) and were randomised to either EMG biofeedback training and conventional medical treatment (BFT) (n = 14) or to conventional medical treatment alone (n = 15). All but one child were able to learn relaxation of the external anal sphincter on attempted defecation. At six months' follow up, laxative free remission had been sustained in two of 14 patients in the BFT group and in two of 15 controls (95% confidence interval (CI) on difference, -24% to 26%). Remission or improvement occurred in four of 14 patients in the BFT group and six of 15 controls (95% CI on difference, -46% to 23%). Of subjects available for repeat anorectal manometry and EMG at six months, six of 13 in the BFT group still demonstrated anismus v 11 of 13 controls (95% CI on difference, -75% to -1%). Of the four patients in full remission at six months, only one (in the BFT group) did not exhibit anismus. Rectal hyposensitivity was not associated with remission or improvement in either of the groups. Mean CBCL total behaviour problem scores were not significantly different between the BFT and control groups, but there

  9. Randomised controlled trial of biofeedback training in persistent encopresis with anismus

    Science.gov (United States)

    Nolan, T.; Catto-Smith, T.; Coffey, C.; Wells, J.

    1998-01-01

    BACKGROUND—Paradoxical external anal sphincter contraction during attempted defecation (anismus) is thought to be an important contributor to chronic faecal retention and encopresis in children. Biofeedback training can be used to teach children to abolish this abnormal contraction.
METHODS—A randomised controlled trial in medical treatment resistant and/or treatment dependent children with anismus using surface electromyographic (EMG) biofeedback training to determine whether such training produces sustained faecal continence. Up to four sessions of biofeedback training were conducted at weekly intervals for each patient. Anorectal manometry was performed before randomisation and six months later. Parents of patients completed the "child behaviour checklist" (CBCL) before randomisation and at follow up.
RESULTS—Sixty eight children underwent anorectal manometry and EMG. Of these, 29 had anismus (ages 4-14 years) and were randomised to either EMG biofeedback training and conventional medical treatment (BFT) (n = 14) or to conventional medical treatment alone (n = 15). All but one child were able to learn relaxation of the external anal sphincter on attempted defecation. At six months' follow up, laxative free remission had been sustained in two of 14 patients in the BFT group and in two of 15 controls (95% confidence interval (CI) on difference, −24% to 26%). Remission or improvement occurred in four of 14 patients in the BFT group and six of 15 controls (95% CI on difference, −46% to 23%). Of subjects available for repeat anorectal manometry and EMG at six months, six of 13 in the BFT group still demonstrated anismus v 11 of 13 controls (95% CI on difference, −75% to −1%). Of the four patients in full remission at six months, only one (in the BFT group) did not exhibit anismus. Rectal hyposensitivity was not associated with remission or improvement in either of the groups. Mean CBCL total behaviour problem scores were not significantly different

  10. Randomised controlled trials of veterinary homeopathy: characterising the peer-reviewed research literature for systematic review.

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    Mathie, Robert T; Hacke, Daniela; Clausen, Jürgen

    2012-10-01

    Systematic review of the research evidence in veterinary homeopathy has never previously been carried out. This paper presents the search methods, together with categorised lists of retrieved records, that enable us to identify the literature that is acceptable for future systematic review of randomised controlled trials (RCTs) in veterinary homeopathy. All randomised and controlled trials of homeopathic intervention (prophylaxis and/or treatment of disease, in any species except man) were appraised according to pre-specified criteria. The following databases were systematically searched from their inception up to and including March 2011: AMED; Carstens-Stiftung Homeopathic Veterinary Clinical Research (HomVetCR) database; CINAHL; Cochrane Central Register of Controlled Trials; Embase; Hom-Inform; LILACS; PubMed; Science Citation Index; Scopus. One hundred and fifty records were retrieved; 38 satisfied the acceptance criteria (substantive report of a clinical treatment or prophylaxis trial in veterinary homeopathic medicine randomised and controlled and published in a peer-reviewed journal), and were thus eligible for future planned systematic review. Approximately half of the rejected records were theses. Seven species and 27 different species-specific medical conditions were represented in the 38 papers. Similar numbers of papers reported trials of treatment and prophylaxis (n=21 and n=17 respectively) and were controlled against placebo or other than placebo (n=18, n=20 respectively). Most research focused on non-individualised homeopathy (n=35 papers) compared with individualised homeopathy (n=3). The results provide a complete and clarified view of the RCT literature in veterinary homeopathy. We will systematically review the 38 substantive peer-reviewed journal articles under the main headings: treatment trials; prophylaxis trials. Copyright © 2012 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

  11. The Hawthorne Effect: a randomised, controlled trial

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    van Haselen Robbert

    2007-07-01

    Full Text Available Abstract Background The 'Hawthorne Effect' may be an important factor affecting the generalisability of clinical research to routine practice, but has been little studied. Hawthorne Effects have been reported in previous clinical trials in dementia but to our knowledge, no attempt has been made to quantify them. Our aim was to compare minimal follow-up to intensive follow-up in participants in a placebo controlled trial of Ginkgo biloba for treating mild-moderate dementia. Methods Participants in a dementia trial were randomised to intensive follow-up (with comprehensive assessment visits at baseline and two, four and six months post randomisation or minimal follow-up (with an abbreviated assessment at baseline and a full assessment at six months. Our primary outcomes were cognitive functioning (ADAS-Cog and participant and carer-rated quality of life (QOL-AD. Results We recruited 176 participants, mainly through general practices. The main analysis was based on Intention to treat (ITT, with available data. In the ANCOVA model with baseline score as a co-variate, follow-up group had a significant effect on outcome at six months on the ADAS-Cog score (n = 140; mean difference = -2.018; 95%CI -3.914, -0.121; p = 0.037 favouring the intensive follow-up group, and on participant-rated quality of life score (n = 142; mean difference = -1.382; 95%CI -2.642, -0.122; p = 0.032 favouring minimal follow-up group. There was no significant difference on carer quality of life. Conclusion We found that more intensive follow-up of individuals in a placebo-controlled clinical trial of Ginkgo biloba for treating mild-moderate dementia resulted in a better outcome than minimal follow-up, as measured by their cognitive functioning. Trial registration Current controlled trials: ISRCTN45577048

  12. The gait and balance of patients with diabetes can be improved: a randomised controlled trial

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    Allet, L.; Armand, S.; de Bie, R. A.; Golay, A.; Monnin, D.; Aminian, K.; Staal, J. B.; de Bruin, E. D.

    2009-01-01

    Aims/hypothesis Gait characteristics and balance are altered in diabetic patients. Little is known about possible treatment strategies. This study evaluates the effect of a specific training programme on gait and balance of diabetic patients. Methods This was a randomised controlled trial (n?=?71) with an intervention (n?=?35) and control group (n?=?36). The intervention consisted of physiotherapeutic group training including gait and balance exercises with function-orientated strengthening (...

  13. Conductive Education as a Method of Stroke Rehabilitation: A Single Blinded Randomised Controlled Feasibility Study

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    Judith Bek

    2016-01-01

    Full Text Available Background. Conductive Education for stroke survivors has shown promise but randomised evidence is unavailable. This study assessed the feasibility of a definitive randomised controlled trial to evaluate efficacy. Methods. Adult stroke survivors were recruited through local community notices. Those completing the baseline assessment were randomised using an online program and group allocation was independent. Intervention group participants received 10 weekly 1.5-hour sessions of Conductive Education at the National Institute of Conductive Education in Birmingham, UK. The control group participants attended two group meetings. The study evaluated the feasibility of recruitment procedures, delivery of the intervention, retention of participants, and appropriateness of outcome measures and data collection methods. Independent assessments included the Barthel Index, the Stroke Impact Scale, the Timed Up and Go test, and the Hospital Anxiety and Depression Scale. Results. Eighty-two patients were enrolled; 77 completed the baseline assessment (46 men, mean age 62.1 yrs. and were randomised. 70 commenced the intervention (n=37 or an equivalent waiting period (n=33. 32/37 completed the 10-week training and 32/33 the waiting period. There were no missing items from completed questionnaires and no adverse events. Discussion. Recruitment, intervention, and assessment methods worked well. Transport issues for intervention and assessment appointments require review. Conclusion. A definitive trial is feasible. This trial is registered with ISRCTN84064492.

  14. A randomised, double blind, placebo-controlled trial of a fixed dose of N-acetyl cysteine in children with autistic disorder.

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    Dean, Olivia M; Gray, Kylie M; Villagonzalo, Kristi-Ann; Dodd, Seetal; Mohebbi, Mohammadreza; Vick, Tanya; Tonge, Bruce J; Berk, Michael

    2017-03-01

    Oxidative stress, inflammation and heavy metals have been implicated in the aetiology of autistic disorder. N-acetyl cysteine has been shown to modulate these pathways, providing a rationale to trial N-acetyl cysteine for autistic disorder. There are now two published pilot studies suggesting efficacy, particularly in symptoms of irritability. This study aimed to explore if N-acetyl cysteine is a useful treatment for autistic disorder. This was a placebo-controlled, randomised clinical trial of 500 mg/day oral N-acetyl cysteine over 6 months, in addition to treatment as usual, in children with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision diagnosis of autistic disorder. The study was conducted in Victoria, Australia. The primary outcome measures were the Social Responsiveness Scale, Children's Communication Checklist-Second Edition and the Repetitive Behavior Scale-Revised. Additionally, demographic data, the parent-completed Vineland Adaptive Behavior Scales, Social Communication Questionnaire and clinician-administered Autism Diagnostic Observation Schedule were completed. A total of 102 children were randomised into the study, and 98 (79 male, 19 female; age range: 3.1-9.9 years) attended the baseline appointment with their parent/guardian, forming the Intention to Treat sample. There were no differences between N-acetyl cysteine and placebo-treated groups on any of the outcome measures for either primary or secondary endpoints. There was no significant difference in the number and severity of adverse events between groups. This study failed to demonstrate any benefit of adjunctive N-acetyl cysteine in treating autistic disorder. While this may reflect a true null result, methodological issues particularly the lower dose utilised in this study may be confounders.

  15. Inositol for the prevention of neural tube defects: a pilot randomised controlled trial.

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    Greene, Nicholas D E; Leung, Kit-Yi; Gay, Victoria; Burren, Katie; Mills, Kevin; Chitty, Lyn S; Copp, Andrew J

    2016-03-28

    Although peri-conceptional folic acid (FA) supplementation can prevent a proportion of neural tube defects (NTD), there is increasing evidence that many NTD are FA non-responsive. The vitamin-like molecule inositol may offer a novel approach to preventing FA-non-responsive NTD. Inositol prevented NTD in a genetic mouse model, and was well tolerated by women in a small study of NTD recurrence. In the present study, we report the Prevention of Neural Tube Defects by Inositol (PONTI) pilot study designed to gain further experience of inositol usage in human pregnancy as a preliminary trial to a future large-scale controlled trial to evaluate efficacy of inositol in NTD prevention. Study subjects were UK women with a previous NTD pregnancy who planned to become pregnant again. Of 117 women who made contact, ninety-nine proved eligible and forty-seven agreed to be randomised (double-blind) to peri-conceptional supplementation with inositol plus FA or placebo plus FA. In total, thirty-three randomised pregnancies produced one NTD recurrence in the placebo plus FA group (n 19) and no recurrences in the inositol plus FA group (n 14). Of fifty-two women who declined randomisation, the peri-conceptional supplementation regimen and outcomes of twenty-two further pregnancies were documented. Two NTD recurred, both in women who took only FA in their next pregnancy. No adverse pregnancy events were associated with inositol supplementation. The findings of the PONTI pilot study encourage a large-scale controlled trial of inositol for NTD prevention, but indicate the need for a careful study design in view of the unwillingness of many high-risk women to be randomised.

  16. Compliance with the CONSORT checklist in obstetric anaesthesia randomised controlled trials.

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    Halpern, S H; Darani, R; Douglas, M J; Wight, W; Yee, J

    2004-10-01

    The Consolidated Standards for Reporting of Trials (CONSORT) checklist is an evidence-based approach to help improve the quality of reporting randomised controlled trials. The purpose of this study was to determine how closely randomised controlled trials in obstetric anaesthesia adhere to the CONSORT checklist. We retrieved all randomised controlled trials pertaining to the practice of obstetric anaesthesia and summarised in Obstetric Anesthesia Digest between March 2001 and December 2002 and compared the quality of reporting to the CONSORT checklist. The median number of correctly described CONSORT items was 65% (range 36% to 100%). Information pertaining to randomisation, blinding of the assessors, sample size calculation, reliability of measurements and reporting of the analysis were often omitted. It is difficult to determine the value and quality of many obstetric anaesthesia clinical trials because journal editors do not insist that this important information is made available to readers. Both clinicians and clinical researchers would benefit from uniform reporting of randomised trials in a manner that allows rapid data retrieval and easy assessment for relevance and quality.

  17. Reducción de niveles de fumonisinas en grano de maíz protegido de insectos

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    Jacqueline Cea

    2011-04-01

    Full Text Available La biotecnología ha hecho posible el desarrollo de híbridos de maíz que están protegidos de insectos lepidópteros barrenadores, mediante la introducción de la secuencia codificante para la proteína Cry1Ab , derivada de  Bacillus thuringiensis (Bt. Estos híbridos se cultivan en diferentes países a partir de 1998, con una adopción que ha llegado al 14% (11.2 millones de hectáreas del área global en 2004 (ISAAA.Existe evidencia de un beneficio adicional derivado de esta  tecnología, en cuanto a la reducción de micotoxinas observada en el grano de estos maíces, atribuída al menor daño provocado por los insectos, considerado una vía de entrada para Fusarium, responsable de la síntesis de fumonisinas. Para este estudio, se llevaron a cabo ensayos de campo en los EEUU, Francia, Argentina y Turquía.Las muestras de granos tomadas fueron sometidas a análisis de micotoxinas en diferentes laboratorios especializados. LATU fue elegido para procesar y analizar las muestras provenientes de ensayos realizados en Argentina.Los  ensayos promediados de los EEUU mostraron una reducción del 46% respecto de los controles no transgénicos. En Argentina, se observaron reducciones de hasta un 60% . En Francia y Turquía  también se mantuvo la tendencia observada, con niveles hasta 7 veces menores en los maíces Bt respecto de los híbridos convencionales. La reducción en los niveles de fumonisinas   al conseguir un grano sano tiene implicancias para la salud en países productores de maíz  con problemas de micotoxinas, y en los cuales el maíz representa una fuente de proteínas importante en la dieta.

  18. Improving health-related fitness in adolescents: the CrossFit Teens™ randomised controlled trial.

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    Eather, Narelle; Morgan, Philip James; Lubans, David Revalds

    2016-01-01

    The aim of this study was to evaluate the preliminary efficacy and feasibility of the CrossFit Teens™ resistance training programme for improving health-related fitness and resistance training skill competency in adolescents. This assessor-blinded randomised controlled trial was conducted in one secondary school in the Hunter Region, Australia, from July to September 2013. Ninety-six (96) students (age = 15.4 (.5) years, 51.5% female) were randomised into intervention (n = 51) or control (n = 45) conditions for 8-weeks (60 min twice per week). Waist circumference, body mass index (BMI), BMI-Z score (primary outcomes), cardiorespiratory fitness (shuttle run test), muscular fitness (standing jump, push-up, handgrip, curl-up test), flexibility (sit and reach) and resistance training skill competency were measured at baseline and immediate post-intervention. Feasibility measures of recruitment, retention, adherence and satisfaction were assessed. Significant group-by-time intervention effects were found for waist circumference [-3.1 cm, P CrossFit Teens™ is a feasible and efficacious programme for improving health-related fitness in adolescents.

  19. First-in-man randomised comparison of the BuMA Supreme biodegradable polymer sirolimus-eluting stent versus a durable polymer zotarolimus-eluting coronary stent: the PIONEER trial.

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    von Birgelen, Clemens; Asano, Taku; Amoroso, Giovanni; Aminian, Adel; Brugaletta, Salvatore; Vrolix, Mathias; Hernandez-Antolín, Rosana; van de Harst, Pim; Iñiguez, Andres; Janssens, Luc; Smits, Pieter C; Wykrzykowska, Joanna J; Ribeiro, Vasco Gama; Pereira, Hélder; da Silva, Pedro Canas; Piek, Jan J; Onuma, Yoshinobu; Serruys, Patrick W; Sabaté, Manel

    2018-04-20

    A second iteration of a sirolimus-eluting stent (SES) that has a biodegradable PLGA polymer coating with an electrografting base layer on a thin-strut (80 µm) cobalt-chromium platform (BuMA Supreme; SINOMED, Tianjin, China) has been developed. This first-in-man trial aimed to assess the efficacy and safety of the novel device. This randomised, multicentre, single-blinded, non-inferiority trial compared the BuMA Supreme SES versus a contemporary durable polymer zotarolimus-eluting stent (ZES) in terms of angiographic in-stent late lumen loss (LLL) at nine-month follow-up as the primary endpoint. A total of 170 patients were randomly allocated to treatment with either SES (n=83) or ZES (n=87). At nine-month angiographic follow-up, in-stent LLL was 0.29±0.33 mm in the SES group and 0.14±0.37 mm in the ZES group (pnon-inferiority=0.45). The in-stent percent diameter stenosis and the binary restenosis rate of the two treatment arms were similar (19.2±12.0% vs. 16.1±12.6%, p=0.09, and 3.3% vs. 4.4%, p=1.00, respectively). At 12-month clinical follow-up, there was no difference between treatment arms with regard to the device-oriented composite clinical endpoint (4.9% vs. 5.7%; p=0.72). The PIONEER trial did not meet its primary endpoint in terms of in-stent LLL at nine-month follow-up. However, this result did not translate into any increase in restenosis rate or impairment in 12-month clinical outcomes.

  20. n-3 polyunsaturated fatty acid supplementation reduces insulin resistance in hepatitis C virus infected patients: a randomised controlled trial.

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    Freire, T O; Boulhosa, R S S B; Oliveira, L P M; de Jesus, R P; Cavalcante, L N; Lemaire, D C; Toralles, M B P; Lyra, L G C; Lyra, A C

    2016-06-01

    Insulin resistance promotes liver disease progression and may be associated with a lower response rate in treated hepatitis C virus (HCV) infected patients. n-3 polyunsaturated fatty acid (PUFA) supplementation may reduce insulin resistance. The present study aimed to evaluate the effect of n-3 PUFA supplementation on insulin resistance in these patients. In a randomised, double-blind clinical trial, 154 patients were screened. After applying inclusion criteria, 52 patients [homeostasis model assessment index of insulin resistance (HOMA-IR ≥2.5)] were randomly divided into two groups: n-3 PUFA (n = 25/6000 mg day(-1) of fish oil) or control (n = 27/6000 mg day(-1) of soybean oil). Both groups were supplemented for 12 weeks and underwent monthly nutritional consultation. Biochemical tests were performed at baseline and after intervention. Statistical analysis was performed using the Wilcoxon Mann-Whitney test for comparisons and the Wilcoxon test for paired data. Statistical package r, version 3.02 (The R Project for Statistical Computing) was used and P resistance in genotype 1 HCV infected patients. © 2015 The British Dietetic Association Ltd.

  1. The gait and balance of patients with diabetes can be improved: a randomised controlled trial.

    NARCIS (Netherlands)

    Allet, L.; Armand, S.; Bie, R.A. de; Golay, A.; Monnin, D.; Aminian, K.; Staal, J.B.; Bruin, E.D. de

    2010-01-01

    AIMS/HYPOTHESIS: Gait characteristics and balance are altered in diabetic patients. Little is known about possible treatment strategies. This study evaluates the effect of a specific training programme on gait and balance of diabetic patients. METHODS: This was a randomised controlled trial (n=71)

  2. Goal-orientated cognitive rehabilitation for dementias associated with Parkinson's disease-A pilot randomised controlled trial.

    Science.gov (United States)

    Hindle, John V; Watermeyer, Tamlyn J; Roberts, Julie; Brand, Andrew; Hoare, Zoe; Martyr, Anthony; Clare, Linda

    2018-05-01

    To examine the appropriateness and feasibility of cognitive rehabilitation for people with dementias associated with Parkinson's in a pilot randomised controlled study. This was a single-blind pilot randomised controlled trial of goal-oriented cognitive rehabilitation for dementias associated with Parkinson's. After goal setting, participants were randomised to cognitive rehabilitation (n = 10), relaxation therapy (n = 10), or treatment-as-usual (n = 9). Primary outcomes were ratings of goal attainment and satisfaction with goal attainment. Secondary outcomes included quality of life, mood, cognition, health status, everyday functioning, and carers' ratings of goal attainment and their own quality of life and stress levels. Assessments were at 2 and 6 months following randomisation. At 2 months, cognitive rehabilitation was superior to treatment-as-usual and relaxation therapy for the primary outcomes of self-rated goal attainment (d = 1.63 and d = 1.82, respectively) and self-rated satisfaction with goal attainment (d = 2.04 and d = 1.84). At 6 months, cognitive rehabilitation remained superior to treatment-as-usual (d = 1.36) and relaxation therapy (d = 1.77) for self-rated goal attainment. Cognitive rehabilitation was superior to treatment as usual and/or relaxation therapy in a number of secondary outcomes at 2 months (mood, self-efficacy, social domain of quality of life, carers' ratings of participants' goal attainment) and at 6 months (delayed recall, health status, quality of life, carer ratings of participants' goal attainment). Carers receiving cognitive rehabilitation reported better quality of life, health status, and lower stress than those allocated to treatment-as-usual. Cognitive rehabilitation is feasible and potentially effective for dementias associated with Parkinson's disease. Copyright © 2018 John Wiley & Sons, Ltd.

  3. Reported challenges in nurse-led randomised controlled trials

    DEFF Research Database (Denmark)

    Wang Vedelø, Tina; Lomborg, Kirsten

    2011-01-01

    Aims: The purpose of this integrative literature review was to explore and discuss the methodological challenges nurse researchers report after conducting nurse-led randomised controlled trials in clinical hospital settings. Our research questions were (i) what are the most commonly experienced...... and the clinical nursing staff. Two lessons learned from this integrative review can be highlighted. First, we recommend researchers openly to share their experiences of barriers and challenges. They should describe factors that may have inhibited the desired outcome. Second, efforts to improve the collaboration...... between nurse researchers and clinicians, including education, training and support may increase the success rate and quality of nurse-led studies using the randomised controlled trial....

  4. Randomised controlled trials in Scandinavian educational research

    DEFF Research Database (Denmark)

    Pontoppidan, Maiken; Keilow, Maria; Dietrichson, Jens

    2018-01-01

    of this paper is to examine the history of randomised controlled trials in Scandinavian compulsory schools (grades 0–10; pupil ages 6-15). Specifically, we investigate drivers and barriers for randomised controlled trials in educational research and the differences between the three Scandinavian countries...... crucial for the implementation of RCTs and are likely more important in smaller countries such as the Scandinavian ones. Supporting institutions have now been established in all three countries, and we believe that the use of RCTs in Scandinavian educational research is likely to continue....... or more interventions were randomly assigned to groups of students and carried out in a school setting with the primary aim of improving the academic performance of children aged 6-15 in grades 0–10 in Denmark, Norway, or Sweden. We included both conducted and ongoing trials. Publications that seemed...

  5. Screening and brief interventions for hazardous and harmful alcohol use in probation services: a cluster randomised controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Myles Judy

    2009-11-01

    Full Text Available Abstract Background A large number of randomised controlled trials in health settings have consistently reported positive effects of brief intervention in terms of reductions in alcohol use. However, although alcohol misuse is common amongst offenders, there is limited evidence of alcohol brief interventions in the criminal justice field. This factorial pragmatic cluster randomised controlled trial with Offender Managers (OMs as the unit of randomisation will evaluate the effectiveness and cost-effectiveness of different models of screening to identify hazardous and harmful drinkers in probation and different intensities of brief intervention to reduce excessive drinking in probation clients. Methods and design Ninety-six OMs from 9 probation areas across 3 English regions (the North East Region (n = 4 and London and the South East Regions (n = 5 will be recruited. OMs will be randomly allocated to one of three intervention conditions: a client information leaflet control condition (n = 32 OMs; 5-minute simple structured advice (n = 32 OMs and 20-minute brief lifestyle counselling delivered by an Alcohol Health Worker (n = 32 OMs. Randomisation will be stratified by probation area. To test the relative effectiveness of different screening methods all OMs will be randomised to either the Modified Single Item Screening Questionnaire (M-SASQ or the Fast Alcohol Screening Test (FAST. There will be a minimum of 480 clients recruited into the trial. There will be an intention to treat analysis of study outcomes at 6 and 12 months post intervention. Analysis will include client measures (screening result, weekly alcohol consumption, alcohol-related problems, re-offending, public service use and quality of life and implementation measures from OMs (the extent of screening and brief intervention beyond the minimum recruitment threshold will provide data on acceptability and feasibility of different models of brief intervention. We will also examine the

  6. Screening and brief interventions for hazardous and harmful alcohol use in probation services: a cluster randomised controlled trial protocol.

    Science.gov (United States)

    Newbury-Birch, Dorothy; Bland, Martin; Cassidy, Paul; Coulton, Simon; Deluca, Paolo; Drummond, Colin; Gilvarry, Eilish; Godfrey, Christine; Heather, Nick; Kaner, Eileen; Myles, Judy; Oyefeso, Adenekan; Parrott, Steve; Perryman, Katherine; Phillips, Tom; Shenker, Don; Shepherd, Jonathan

    2009-11-18

    A large number of randomised controlled trials in health settings have consistently reported positive effects of brief intervention in terms of reductions in alcohol use. However, although alcohol misuse is common amongst offenders, there is limited evidence of alcohol brief interventions in the criminal justice field. This factorial pragmatic cluster randomised controlled trial with Offender Managers (OMs) as the unit of randomisation will evaluate the effectiveness and cost-effectiveness of different models of screening to identify hazardous and harmful drinkers in probation and different intensities of brief intervention to reduce excessive drinking in probation clients. Ninety-six OMs from 9 probation areas across 3 English regions (the North East Region (n = 4) and London and the South East Regions (n = 5)) will be recruited. OMs will be randomly allocated to one of three intervention conditions: a client information leaflet control condition (n = 32 OMs); 5-minute simple structured advice (n = 32 OMs) and 20-minute brief lifestyle counselling delivered by an Alcohol Health Worker (n = 32 OMs). Randomisation will be stratified by probation area. To test the relative effectiveness of different screening methods all OMs will be randomised to either the Modified Single Item Screening Questionnaire (M-SASQ) or the Fast Alcohol Screening Test (FAST). There will be a minimum of 480 clients recruited into the trial. There will be an intention to treat analysis of study outcomes at 6 and 12 months post intervention. Analysis will include client measures (screening result, weekly alcohol consumption, alcohol-related problems, re-offending, public service use and quality of life) and implementation measures from OMs (the extent of screening and brief intervention beyond the minimum recruitment threshold will provide data on acceptability and feasibility of different models of brief intervention). We will also examine the practitioner and organisational factors

  7. Estudio de la cinética de oxidación de la superaleación MA 956 M

    Directory of Open Access Journals (Sweden)

    García-Alonso, C.

    1998-05-01

    Full Text Available This work deals with the oxidation kinetics of the MA 956 superalloy in the temperature range of 800-1,200°C for up to 200 h exposure. During oxidation the alloy develops a fine, compact and very well adhered α-alumina layer, the thickness of which increases with increasing time and temperature. The oxidation kinetics obeys a subparabolic type behaviour. The scale growth seems to occur by two different oxidation mechanisms; above 1,050°C, the oxidation process would be controlled by α-alumina, and below 900°C by γ-alumina.

    Se estudia la cinética de oxidación de la superaleación MA 956 en el intervalo de temperaturas 800-1.200°C durante tiempos de tratamiento de hasta 200 h. Durante la oxidación, se forma una capa de alúmina fina, densa y muy bien adherida cuyo espesor aumenta al aumentar el tiempo y la temperatura. La cinética de oxidación puede describirse mediante una ley de tipo subparabólico. El crecimiento de la capa de alúmina en el intervalo de temperaturas estudiado parece estar controlado por dos mecanismos distintos; por encima de 1.050°C se forma alúmina α y por debajo de los 900ºC alúmina γ.

  8. Comprehensive analysis of NuMA variation in breast cancer

    Directory of Open Access Journals (Sweden)

    Aittomäki Kristiina

    2008-03-01

    Full Text Available Abstract Background A recent genome wide case-control association study identified NuMA region on 11q13 as a candidate locus for breast cancer susceptibility. Specifically, the variant Ala794Gly was suggested to be associated with increased risk of breast cancer. Methods In order to evaluate the NuMa gene for breast cancer susceptibility, we have here screened the entire coding region and exon-intron boundaries of NuMa in 92 familial breast cancer patients and constructed haplotypes of the identified variants. Five missense variants were further screened in 341 breast cancer cases with a positive family history and 368 controls. We examined the frequency of Ala794Gly in an extensive series of familial (n = 910 and unselected (n = 884 breast cancer cases and controls (n = 906, with a high power to detect the suggested breast cancer risk. We also tested if the variant is associated with histopathologic features of breast tumors. Results Screening of NuMA resulted in identification of 11 exonic variants and 12 variants in introns or untranslated regions. Five missense variants that were further screened in breast cancer cases with a positive family history and controls, were each carried on a unique haplotype. None of the variants, or the haplotypes represented by them, was associated with breast cancer risk although due to low power in this analysis, very low risk alleles may go unrecognized. The NuMA Ala794Gly showed no difference in frequency in the unselected breast cancer case series or familial case series compared to control cases. Furthermore, Ala794Gly did not show any significant association with histopathologic characteristics of the tumors, though Ala794Gly was slightly more frequent among unselected cases with lymph node involvement. Conclusion Our results do not support the role of NuMA variants as breast cancer susceptibility alleles.

  9. Comprehensive analysis of NuMA variation in breast cancer

    International Nuclear Information System (INIS)

    Kilpivaara, Outi; Rantanen, Matias; Tamminen, Anitta; Aittomäki, Kristiina; Blomqvist, Carl; Nevanlinna, Heli

    2008-01-01

    A recent genome wide case-control association study identified NuMA region on 11q13 as a candidate locus for breast cancer susceptibility. Specifically, the variant Ala794Gly was suggested to be associated with increased risk of breast cancer. In order to evaluate the NuMa gene for breast cancer susceptibility, we have here screened the entire coding region and exon-intron boundaries of NuMa in 92 familial breast cancer patients and constructed haplotypes of the identified variants. Five missense variants were further screened in 341 breast cancer cases with a positive family history and 368 controls. We examined the frequency of Ala794Gly in an extensive series of familial (n = 910) and unselected (n = 884) breast cancer cases and controls (n = 906), with a high power to detect the suggested breast cancer risk. We also tested if the variant is associated with histopathologic features of breast tumors. Screening of NuMA resulted in identification of 11 exonic variants and 12 variants in introns or untranslated regions. Five missense variants that were further screened in breast cancer cases with a positive family history and controls, were each carried on a unique haplotype. None of the variants, or the haplotypes represented by them, was associated with breast cancer risk although due to low power in this analysis, very low risk alleles may go unrecognized. The NuMA Ala794Gly showed no difference in frequency in the unselected breast cancer case series or familial case series compared to control cases. Furthermore, Ala794Gly did not show any significant association with histopathologic characteristics of the tumors, though Ala794Gly was slightly more frequent among unselected cases with lymph node involvement. Our results do not support the role of NuMA variants as breast cancer susceptibility alleles

  10. Fumonisinas –Síntesis y función en la interacción Fusarium verticillioides-maíz

    Directory of Open Access Journals (Sweden)

    Ma. Eugenia de la Torre-Hernández

    2014-01-01

    Full Text Available Fusarium verticillioides es el principal hongo patógeno que afecta la productividad del maíz en el mundo. Este hongo penetra a la planta por distintas rutas e infecta raíces, tallo y mazorca. El patógeno produce varias toxinas en el tejido y en los granos del maíz, lo que disminuye su calidad. Las fumonisinas son las toxinas mayoritarias excretadas por el hongo. Un grupo de genes forma el locus FUM en el cromosoma 1 de F. verticillioides y codifica las enzimas responsables de la síntesis de las fumonisinas. Sin embargo, la cantidad de fumonisina producida es altamente variable entre cepas del hongo. La regulación de la síntesis es muy compleja y depende de factores ambientales y nutricionales, así como de múltiples vías de señalización que ejercen tanto regulación positiva como negativa. Las fumonisinas son consideradas factores de virulencia, ya que su producción se asocia con una mayor capacidad de infección de F. verticillioides en plántulas de maíz. Sin embargo, este papel no es claro en la infección y pudrición de la mazorca. En maíz, las fumonisinas tienen tres blancos moleculares que son la esfinganina N-acil transferasa, la ATPasa de protones de membrana plasmática y las β-1,3-glucanasas básicas. Las tres enzimas tienen funciones fisiológicas relevantes y participan en la respuesta de defensa de la planta.

  11. A dose response randomised controlled trial of docosahexaenoic acid (DHA) in preterm infants.

    Science.gov (United States)

    Collins, C T; Sullivan, T R; McPhee, A J; Stark, M J; Makrides, M; Gibson, R A

    2015-08-01

    Thirty one infants born less than 30 weeks׳ gestational age were randomised to receive either 40 (n=11), 80 (n=9) or 120 (n=11) mg/kg/day of docosahexaenoic acid (DHA) respectively as an emulsion, via the feeding tube, commenced within 4 days of the first enteral feed. Twenty three infants were enroled in non-randomised reference groups; n=11 who had no supplementary DHA and n=12 who had maternal DHA supplementation. All levels of DHA in the emulsion were well tolerated with no effect on number of days of interrupted feeds or days to full enteral feeds. DHA levels in diets were directly related to blood DHA levels but were unrelated to arachidonic acid (AA) levels. All randomised groups and the maternal supplementation reference group prevented the drop in DHA levels at study end that was evident in infants not receiving supplementation. Australian New Zealand Clinical Trials Registry: ACTRN12610000382077. Copyright © 2015 Elsevier Ltd. All rights reserved.

  12. Propuesta de cotejo de impacto de la acumulación de transgenes en el maíz (Zea mays L.) nativo mexicano

    OpenAIRE

    Turrent-Fernández, Antonio; Serratos-Hernández, J. Antonio; Mejía-Andrade, Hugo; Espinosa-Calderón, Alejandro

    2009-01-01

    La liberación del cultivo de maíz genéticamente modificado (MGM) a escala comercial en México, involucra potencialmente la interacción genética entre más de 30 eventos transgénicos independientes (probablemente más de 30 loci transgénicos diferentes) y más de 50 razas nativas de maíz (RNM) en el campo mexicano. Aunque la Ley de Bioseguridad de Organismos Genéticamente Modificados (LBOGM) y su reglamento establecen el supuesto de que el control del polen permite minimizar la interacción genéti...

  13. Exercise and Manual therapy Arthritis Research Trial (EMPART) for osteoarthritis of the hip: A Multicentre Randomised Controlled trial.

    LENUS (Irish Health Repository)

    French, Helen P

    2012-10-16

    OBJECTIVE: To determine the effectiveness of exercise therapy (ET) compared to ET with adjunctive manual therapy (ET+MT) for people with hip osteoarthritis (OA). A secondary aim was to identify if immediate commencement of ET or ET+MT was more beneficial than a 9 week waiting period for either intervention. DESIGN: Assessor-blind randomised controlled trial with 9 and 18 week follow-ups. SETTING: Four academic teaching hospitals, Dublin, Ireland. PARTICIPANTS: 131 patients with hip OA recruited from general practitioners, rheumatologists, orthopaedic surgeons, and other hospital consultants were randomised to one of three groups: ET (n=45), ET+MT (n=43) and wait-list control (n=43). INTERVENTIONS: Participants in both ET and ET+ MT groups received up to 8 treatments over 8 weeks. Control group participants were re-randomised into either ET or ET+MT group after 9 week follow-up. Their data were pooled with original treatment group data: ET (n=66) and ET+MT (n=65). MAIN OUTCOME MEASURES: The primary outcome was the WOMAC physical function (PF) subscale. Secondary outcomes included physical performance, pain, hip range of motion (HROM), anxiety\\/depression, quality of life, medication usage, patient-perceived change and patient satisfaction. RESULTS: There was no significant difference in WOMAC PF between ET (n=66) and ET+MT (n=65) groups at 9 weeks (mean diff 0.09 (95% CI -4.41, 5.25)) or at 18 weeks (mean diff 0.42 (95% CI -3.98, 6.83)), or other outcomes, except \\'patient satisfaction with outcome\\' which was higher in the ET+MT group (p=0.02). Improvements in WOMAC, HROM and patient-perceived change occurred in both treatment groups compared with the control group. CONCLUSION: Self-reported function, HROM and patient-perceived improvement occurred after an 8 week programme of ET for patients with hip OA MT as an adjunct provided no further benefit, except for higher patient satisfaction.

  14. Estrategias de reproducción social de los productores de maíz de Tlaxcala

    Directory of Open Access Journals (Sweden)

    Miguel Ángel Damián Huato

    2009-01-01

    Full Text Available Se analizan las múltiples estrategias de reproducción social de los productores de maíz del estado de Tlaxcala y el efecto que ha tenido la pluriactividad en el manejo del maíz y de otros recursos, así como en el desarrollo sustentable y humano. Con este fin se recurrió a información acopiada por una encuesta aplicada en el año de 2002 a una muestra de 1,884 maiceros. Los resultados indican que, aparte de producir maíz, 74% vende su fuerza de trabajo para sobrevivir, realizando distintas actividades; una sexta parte de productores o de sus familiares tienen que emigrar para contribuir al sustento familiar; las actividades pri- marias (siembra de maíz, ganadería y recolección de bienes, aunque aportan menor cantidad de recursos económicos, son estrategias de gran importancia por garantizar la reproducción social de la unidad campesina. Finalmente, no se encontró ninguna evidencia que demuestre que la política agropecuaria haya contribuido a mejorar la productividad, el bienestar social y la sustentabilidad de los recursos naturales de los productores de maíz del estado de Tlaxcala.

  15. Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications.

    Science.gov (United States)

    Kasenda, Benjamin; Schandelmaier, Stefan; Sun, Xin; von Elm, Erik; You, John; Blümle, Anette; Tomonaga, Yuki; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Meerpohl, Joerg J; Stegert, Mihaela; Olu, Kelechi K; Tikkinen, Kari A O; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M; Mertz, Dominik; Akl, Elie A; Bassler, Dirk; Busse, Jason W; Ferreira-González, Ignacio; Lamontagne, Francois; Nordmann, Alain; Gloy, Viktoria; Raatz, Heike; Moja, Lorenzo; Rosenthal, Rachel; Ebrahim, Shanil; Vandvik, Per O; Johnston, Bradley C; Walter, Martin A; Burnand, Bernard; Schwenkglenks, Matthias; Hemkens, Lars G; Bucher, Heiner C; Guyatt, Gordon H; Briel, Matthias

    2014-07-16

    To investigate the planning of subgroup analyses in protocols of randomised controlled trials and the agreement with corresponding full journal publications. Cohort of protocols of randomised controlled trial and subsequent full journal publications. Six research ethics committees in Switzerland, Germany, and Canada. 894 protocols of randomised controlled trial involving patients approved by participating research ethics committees between 2000 and 2003 and 515 subsequent full journal publications. Of 894 protocols of randomised controlled trials, 252 (28.2%) included one or more planned subgroup analyses. Of those, 17 (6.7%) provided a clear hypothesis for at least one subgroup analysis, 10 (4.0%) anticipated the direction of a subgroup effect, and 87 (34.5%) planned a statistical test for interaction. Industry sponsored trials more often planned subgroup analyses compared with investigator sponsored trials (195/551 (35.4%) v 57/343 (16.6%), P<0.001). Of 515 identified journal publications, 246 (47.8%) reported at least one subgroup analysis. In 81 (32.9%) of the 246 publications reporting subgroup analyses, authors stated that subgroup analyses were prespecified, but this was not supported by 28 (34.6%) corresponding protocols. In 86 publications, authors claimed a subgroup effect, but only 36 (41.9%) corresponding protocols reported a planned subgroup analysis. Subgroup analyses are insufficiently described in the protocols of randomised controlled trials submitted to research ethics committees, and investigators rarely specify the anticipated direction of subgroup effects. More than one third of statements in publications of randomised controlled trials about subgroup prespecification had no documentation in the corresponding protocols. Definitive judgments regarding credibility of claimed subgroup effects are not possible without access to protocols and analysis plans of randomised controlled trials. © The DISCO study group 2014.

  16. Effects of high volume saline enemas vs no enema during labour – The N-Ma Randomised Controlled Trial [ISRCTN43153145

    Directory of Open Access Journals (Sweden)

    Bernal María

    2006-03-01

    Full Text Available Abstract Background Enemas are used during labour in obstetric settings with the belief that they reduce puerperal and neonatal infections, shorten labour duration, and make delivery cleaner for attending personnel. However, a systematic review of the literature found insufficient evidence to support the use of enemas. The objective of this RCT was to address an identified knowledge gap by determining the effect of routine enemas used during the first stage of labour on puerperal and neonatal infection rates. Methods Design: RCT (randomised controlled trial; randomized clinical trial. Outcomes: Clinical diagnosis of maternal or neonatal infections, labour duration, delivery types, episiotomy rates, and prescription of antibiotics Setting: Tertiary care referral hospital at the Javeriana University (Bogotá, Colombia that attended 3170 births during study period with a caesarean section rate of 26%. Participants: 443 women admitted for delivery to the obstetrics service (February 1997 to February 1998 and followed for a month after delivery. Inclusion criteria were women with: low risk pregnancy and expected to remain in Bogotá during follow up; gestational age ≥ 36 weeks; no pelvic or systemic bacterial infection; intact membranes; cervix dilatation ≤7 cm. Intervention: 1 litre saline enema, versus no enema, allocated following a block random allocation sequence and using sealed opaque envelopes. Results Allocation provided balanced groups and 86% of the participants were followed up for one month. The overall infection rate for newborns was 21%, and 18% for women. We found no significant differences in puerperal or neonatal infection rates (Puerperal infection: 41/190 [22%] with enema v 26/182 [14%] without enema; RR 0.66 CI 95%: 0.43 to 1.03; neonatal infection 38/191 [20%] with enema v 40/179 [22%] without enema; RR 1.12, 95% CI 95% 0.76 to 1.66, and median labour time was similar between groups (515 min. with enema v 585 min. without

  17. Healthcare costs in the Danish randomised controlled lung cancer CT-screening trial

    DEFF Research Database (Denmark)

    Rasmussen, J.F.; Siersma, V.; Pedersen, Jesper H.

    2014-01-01

    : This registry study was nested in a randomised controlled trial (DLCST). 4104 participants, current or former heavy smokers, aged 50-70 years were randomised to five annual low dose CT scans or usual care during 2004-2010. Total healthcare costs and healthcare utilisation data for both the primary...... and the secondary healthcare sector were retrieved from public registries from randomisation - September 2011 and compared between (1) the CT-screening group and the control group and, (2) the control group and each of the true-positive, false-positive and true-negative groups. RESULTS: The median annual costs per...... participant were significantly higher in the CT-screening group (Euros [EUR] 1342, interquartile range [IQR] 750-2980) compared with the control group (EUR 1190, IQR 590-2692) (pcost of the CT-screening programme was excluded, there was no longer a statistically significant difference...

  18. Influence of reported study design characteristics on intervention effect estimates from randomised controlled trials

    DEFF Research Database (Denmark)

    Savović, J; Jones, He; Altman, Dg

    2012-01-01

    The design of randomised controlled trials (RCTs) should incorporate characteristics (such as concealment of randomised allocation and blinding of participants and personnel) that avoid biases resulting from lack of comparability of the intervention and control groups. Empirical evidence suggests...

  19. a randomised controlled trial oftwo prostaglandin regitnens

    African Journals Online (AJOL)

    Design. A prospective randomised controlled trial. Setting. Department of Obstetrics and Gynae- ... hours after the original administration of either prostaglandin regimen. If abortion had not taken place 36 .... Tygerberg Hospital for permission to publish, and Upjohn. (Pry) Ltd for supplying the Prepidil gel used in the study. 1.

  20. Effect of low-protein diet on kidney function in diabetic nephropathy: meta-analysis of randomised controlled trials.

    Science.gov (United States)

    Nezu, Uru; Kamiyama, Hiroshi; Kondo, Yoshinobu; Sakuma, Mio; Morimoto, Takeshi; Ueda, Shinichiro

    2013-05-28

    To evaluate the effect of low-protein diet on kidney function in patients with diabetic nephropathy. A systematic review and a meta-analysis of randomised controlled trials. MEDLINE, EMBASE, Cochrane Library, ClinicalTrials.gov, International Standard Randomised Controlled Trial Number (ISRCTN) Register and University Hospital Medical Information Network-Clinical Trials Registry (UMIN-CTR) from inception to 10 December 2012. Internet searches were also carried out with general search engines (Google and Google Scholar). Randomised controlled trials that compared low-protein diet versus control diet and assessed the effects on kidney function, proteinuria, glycaemic control or nutritional status. The primary outcome was a change in the glomerular filtration rate (GFR). The secondary outcomes were changes in proteinuria, post-treatment value of glycated haemoglobin A1C (HbA1c) and post-treatment value of serum albumin. The results were summarised as the mean difference for continuous outcomes and pooled by the random effects model. Subgroup analyses and sensitivity analyses were conducted regarding patient characteristics, intervention period, methodological quality and assessment of diet compliance. The assessment of diet compliance was performed based on the actual protein intake ratio (APIR) of the low-protein diet group to the control group. We identified 13 randomised controlled trials enrolling 779 patients. A low-protein diet was associated with a significant improvement in GFR (5.82 ml/min/1.73 m(2), 95% CI 2.30 to 9.33, I(2)=92%; n=624). This effect was consistent across the subgroups of type of diabetes, stages of nephropathy and intervention period. However, GFR was improved only when diet compliance was fair (8.92, 95% CI 2.75 to 15.09, I(2)=92% for APIR <0.9 and 0.03, 95% CI -1.49 to 1.56, I(2)=90% for APIR ≥0.9). Proteinuria and serum albumin were not differed between the groups. HbA1c was slightly but significantly decreased in the low-protein diet

  1. Vitamin D treatment in calcium-deficiency rickets: a randomised controlled trial.

    Science.gov (United States)

    Thacher, Tom D; Fischer, Philip R; Pettifor, John M

    2014-09-01

    To determine whether children with calcium-deficiency rickets have a better response to treatment with vitamin D and calcium than with calcium alone. Randomised controlled trial. Jos University Teaching Hospital, Jos, Nigeria. Nigerian children with active rickets treated with calcium carbonate as limestone (approximately 938 mg elemental calcium twice daily) were, in addition, randomised to receive either oral vitamin D2 50,000 IU (Ca+D, n=44) or placebo (Ca, n=28) monthly for 24 weeks. Achievement of a 10-point radiographic severity score ≤1.5 and serum alkaline phosphatase ≤350 U/L. The median (range) age of enrolled children was 46 (15-102) months, and baseline characteristics were similar in the two groups. Mean (±SD) 25-hydroxyvitamin D (25(OH)D) was 30.2±13.2 nmol/L at baseline, and 29 (43%) had values rickets, there is a trend for vitamin D to improve the response to treatment with calcium carbonate as limestone, independent of baseline 25(OH)D concentrations. ClinicalTrials.gov NCT00949832. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  2. Randomised controlled trial of a general practice programme of home based exercise to prevent falls in elderly women.

    OpenAIRE

    Campbell, A. J.; Robertson, M. C.; Gardner, M. M.; Norton, R. N.; Tilyard, M. W.; Buchner, D. M.

    1997-01-01

    OBJECTIVE: To assess the effectiveness of a home exercise programme of strength and balance retraining exercises in reducing falls and injuries in elderly women. DESIGN: Randomised controlled trial of an individually tailored programme of physical therapy in the home (exercise group, n = 116) compared with the usual care and an equal number of social visits (control group, n = 117). SETTING: 17 general practices in Dunedin, New Zealand. SUBJECTS: Women aged 80 years and older living in the co...

  3. Is the randomised controlled trial the best?

    African Journals Online (AJOL)

    The randomised controlled trial (RCT) is recog nised as the gold standard of research methods, particularly to test efficacy. The primary benefit of the RCT, as everyone knows, is to prevent patient selection bias. And it should also guarantee some rigour of research methodology. It is always prospective. In a nonrandomised ...

  4. Psychosocial consequences of allocation to lung cancer screening: a randomised controlled trial.

    Science.gov (United States)

    Aggestrup, Louise Mosborg; Hestbech, Mie Sara; Siersma, Volkert; Pedersen, Jesper Holst; Brodersen, John

    2012-01-01

    To examine the psychosocial consequences of being allocated to the control group as compared with the screen group in a randomised lung cancer screening trial. The Danish Lung Cancer Screening Trial, a randomised controlled trial, ran from 2004 to 2010 with the purpose of investigating the benefits and harms of lung cancer screening. The participants in Danish Lung Cancer Screening Trial were randomised to either the control group or the screen group and were asked to complete the questionnaires Consequences Of Screening and Consequences Of Screening in Lung Cancer (COS-LC). The Consequences Of Screening and the COS-LC were used to examine the psychosocial consequences of participating in the study, by comparing the control and the screen groups' responses at the prevalence and at the incidence round. There was no statistically significant difference in socio-demographic characteristics or smoking habits between the two groups. Responses to the COS-LC collected before the incidence round were statistically significantly different on the scales 'anxiety', 'behaviour', 'dejection', 'self-blame', 'focus on airway symptoms' and 'introvert', with the control group reporting higher negative psychosocial consequences. Furthermore, the participants in both the control and the screen groups exhibited a mean increase in negative psychosocial consequences when their responses from the prevalence round were compared with their responses from the first incidence round. Participation in a randomised controlled trial on lung cancer screening has negative psychosocial consequences for the apparently healthy participants-both the participants in the screen group and the control group. This negative impact was greatest for the control group.

  5. Methodological considerations for a randomised controlled trial of podiatry care in rheumatoid arthritis: lessons from an exploratory trial.

    Science.gov (United States)

    Turner, Deborah E; Helliwell, Philip S; Woodburn, James

    2007-11-06

    Whilst evidence exists to support the use of single treatments such as orthoses and footwear, the effectiveness of podiatry-led care as a complex intervention for patients with rheumatoid arthritis (RA) related foot problems is unknown. The aim of this study was to undertake an exploratory randomised controlled parallel arm clinical trial (RheumAFooT) to inform the design and implementation of a definitive trial and to understand the potential benefits of this care. Patients with a definite diagnosis of RA, stable drug management 3 months prior to entry, and a current history of foot problems (pain, deformity, stiffness, skin or nail lesions, or footwear problems) were recruited from a hospital outpatient rheumatology clinic and randomised to receive 12 months of podiatry treatment or no care. The primary outcome was change in foot health status using the impairment/footwear (LFISIF) and activity limitation/participation restriction (LFISAP) subscales of the Leeds Foot Impact Scale. Disease Activity Score (DAS), Health Assessment Questionnaire (HAQ) score and walking speed (m/s) were also recorded. Of the 80 patients identified, 64 patients were eligible to participate in the pilot and 34 were recruited. 16 patients were randomised to receive podiatry led foot care and 18 received no care. Against a backdrop of stable disease (DAS and HAQ scores), there was a statistically significant between group difference in the change in foot health status for foot impairment (LFISIF) but not activity/participation (LFISAP) or function (walking speed) over 12 months. In the podiatry arm, 1 patient declined treatment following randomisation (did not want additional hospital visits) and 3 self-withdrew (lost to follow-up). Patients received an average of 3 consultations for assessment and treatment comprising routine care for skin and nail lesions (n = 3), foot orthoses (n = 9), footwear referral to the orthotist (n = 5), and ultrasound guided intra-articular steroid injection

  6. Randomised controlled trials: important but overrated?

    LENUS (Irish Health Repository)

    Boylan, J F

    2012-02-01

    Practising physicians individualise treatments, hoping to achieve optimal outcomes by tackling relevant patient variables. The randomised controlled trial (RCT) is universally accepted as the best means of comparison. Yet doctors sometimes wonder if particular patients might benefit more from treatments that fared worse in the RCT comparisons. Such clinicians may even feel ostracised by their peers for stepping outside treatments based on RCTs and guidelines. Are RCTs the only acceptable evaluations of how patient care can be assessed and delivered? In this controversy we explore the interpretation of RCT data for practising clinicians facing individualised patient choices. First, critical care anaesthetists John Boylan and Brian Kavanagh emphasise the dangers of bias and show how Bayesian approaches utilise prior probabilities to improve posterior (combined) probability estimates. Secondly, Jane Armitage, of the Clinical Trial Service Unit in Oxford, argues why RCTs remain essential and explores how the quality of randomisation can be improved through systematic reviews and by avoiding selective reporting.

  7. Implementation of physical coordination training and cognitive behavioural training interventions at cleaning workplaces - secondary analyses of a randomised controlled trial

    DEFF Research Database (Denmark)

    Jørgensen, Marie B; Faber, Anne; Jespersen, Tobias

    2012-01-01

    intervention effects, more research on implementation is needed. Trial registration: ISRCTN96241850. Practitioner summary: Both physical coordination training and cognitive behavioural training are potential effective workplace interventions among low educated job groups with high physical work demands......This study evaluates the implementation of physical coordination training (PCT) and cognitive behavioural training (CBTr) interventions in a randomised controlled trial at nine cleaners' workplaces. Female cleaners (n = 294) were randomised into a PCT, a CBTr or a reference (REF) group. Both 12...

  8. Transitional care for the highest risk patients: findings of a randomised control study

    Directory of Open Access Journals (Sweden)

    Kheng Hock Lee

    2015-10-01

    Full Text Available Background: Interventions to prevent readmissions of patients at highest risk have not been rigorously evaluated. We conducted a randomised controlled trial to determine if a post-discharge transitional care programme can reduce readmissions of such patients in Singapore. Methods: We randomised 840 patients with two or more unscheduled readmissions in the prior 90 days and Length of stay, Acuity of admission, Comorbidity of patient, Emergency department utilisation score ≥10 to the intervention programme (n = 419 or control (n = 421. Patients allocated to the intervention group received post-discharge surveillance by a multidisciplinary integrated care team and early review in the clinic. The primary outcome was the proportion of patients with at least one unscheduled readmission within 30 days after discharge. Results: We found no statistically significant reduction in readmissions or emergency department visits in patients on the intervention group compared to usual care. However, patients in the intervention group reported greater patient satisfaction (p < 0.001. Conclusion: Any beneficial effect of interventions initiated after discharge is small for high-risk patients with multiple comorbidity and complex care needs. Future transitional care interventions should focus on providing the entire cycle of care for such patients starting from time of admission to final transition to the primary care setting. Trial Registration: Clinicaltrials.gov, no NCT02325752

  9. Transitional care for the highest risk patients: findings of a randomised control study

    Directory of Open Access Journals (Sweden)

    Kheng Hock Lee

    2015-10-01

    Full Text Available Background: Interventions to prevent readmissions of patients at highest risk have not been rigorously evaluated. We conducted a randomised controlled trial to determine if a post-discharge transitional care programme can reduce readmissions of such patients in Singapore.Methods: We randomised 840 patients with two or more unscheduled readmissions in the prior 90 days and Length of stay, Acuity of admission, Comorbidity of patient, Emergency department utilisation score ≥10 to the intervention programme (n = 419 or control (n = 421. Patients allocated to the intervention group received post-discharge surveillance by a multidisciplinary integrated care team and early review in the clinic. The primary outcome was the proportion of patients with at least one unscheduled readmission within 30 days after discharge.Results: We found no statistically significant reduction in readmissions or emergency department visits in patients on the intervention group compared to usual care. However, patients in the intervention group reported greater patient satisfaction (p < 0.001.Conclusion: Any beneficial effect of interventions initiated after discharge is small for high-risk patients with multiple comorbidity and complex care needs. Future transitional care interventions should focus on providing the entire cycle of care for such patients starting from time of admission to final transition to the primary care setting.Trial Registration: Clinicaltrials.gov, no NCT02325752

  10. A pilot randomised controlled study of the mental health first aid eLearning course with UK medical students.

    Science.gov (United States)

    Davies, E Bethan; Beever, Emmeline; Glazebrook, Cris

    2018-03-21

    Medical students face many barriers to seeking out professional help for their mental health, including stigma relating to mental illness, and often prefer to seek support and advice from fellow students. Improving medical students' mental health literacy and abilities to support someone experiencing a mental health problem could reduce barriers to help seeking and improve mental health in this population. Mental Health First Aid (MHFA) is an evidence-based intervention designed to improve mental health literacy and ability to respond to someone with a mental health problem. This pilot randomised controlled trial aims to evaluate the MHFA eLearning course in UK medical students. Fifty-five medical students were randomised to receive six weeks access to the MHFA eLearning course (n = 27) or to a no-access control group (n = 28). Both groups completed baseline (pre-randomisation) and follow-up (six weeks post-randomisation) online questionnaires measuring recognition of a mental health problem, mental health first aid intentions, confidence to help a friend experiencing a mental health problem, and stigmatising attitudes. Course feedback was gathered at follow-up. More participants were lost follow-up in the MHFA group (51.9%) compared to control (21.4%). Both intention-to-treat (ITT) and non-ITT analyses showed that the MHFA intervention improved mental health first aid intentions (p = first aid actions at follow-up (p = .006). Feedback about the MHFA course was generally positive, with participants stating it helped improve their knowledge and confidence to help someone. This pilot study demonstrated the potential for the MHFA eLearning course to improve UK medical students' mental health first aid skills, confidence to help a friend and stigmatising attitudes. It could be useful in supporting their own and others' mental health while studying and in their future healthcare careers. Retrospectively registered ( ISRCTN11219848 ).

  11. Effects of adjuvant exemestane versus anastrozole on bone mineral density for women with early breast cancer (MA.27B): a companion analysis of a randomised controlled trial.

    Science.gov (United States)

    Goss, Paul E; Hershman, Dawn L; Cheung, Angela M; Ingle, James N; Khosla, Sundeep; Stearns, Vered; Chalchal, Haji; Rowland, Kendrith; Muss, Hyman B; Linden, Hannah M; Scher, Judite; Pritchard, Kathleen I; Elliott, Catherine R; Badovinac-Crnjevic, Tanja; St Louis, Jessica; Chapman, Judith-Anne W; Shepherd, Lois E

    2014-04-01

    Treatment of breast cancer with aromatase inhibitors is associated with damage to bones. NCIC CTG MA.27 was an open-label, phase 3, randomised controlled trial in which women with breast cancer were assigned to one of two adjuvant oral aromatase inhibitors-exemestane or anastrozole. We postulated that exemestane-a mildly androgenic steroid-might have a less detrimental effect on bone than non-steroidal anastrozole. In this companion study to MA.27, we compared changes in bone mineral density (BMD) in the lumbar spine and total hip between patients treated with exemestane and patients treated with anastrozole. In MA.27, postmenopausal women with early stage hormone (oestrogen) receptor-positive invasive breast cancer were randomly assigned to exemestane 25 mg versus anastrozole 1 mg, daily. MA.27B recruited two groups of women from MA.27: those with BMD T-scores of -2·0 or more (up to 2 SDs below sex-matched, young adult mean) and those with at least one T-score (hip or spine) less than -2·0. Both groups received vitamin D and calcium; those with baseline T-scores of less than -2·0 also received bisphosphonates. The primary endpoints were percent change of BMD at 2 years in lumbar spine and total hip for both groups. We analysed patients according to which aromatase inhibitor and T-score groups they were allocated to but BMD assessments ceased if patients deviated from protocol. This study is registered with ClinicalTrials.gov, NCT00354302. Between April 24, 2006, and May 30, 2008, 300 patients with baseline T-scores of -2·0 or more were accrued (147 allocated exemestane, 153 anastrozole); and 197 patients with baseline T-scores of less than -2·0 (101 exemestane, 96 anastrozole). For patients with T-scores greater than -2·0 at baseline, mean change of bone mineral density in the spine at 2 years did not differ significantly between patients taking exemestane and patients taking anastrozole (-0·92%, 95% CI -2·35 to 0·50 vs -2·39%, 95% CI -3·77 to -1·01; p

  12. A randomised controlled trial of the use of aromatherapy and hand massage to reduce disruptive behaviour in people with dementia.

    Science.gov (United States)

    Fu, Chieh-Yu; Moyle, Wendy; Cooke, Marie

    2013-07-10

    Aromatherapy and hand massage therapies have been reported to have some benefit for people with dementia who display behavioural symptoms; however there are a number of limitations of reported studies. The aim is to investigate the effect of aromatherapy (3% lavender oil spray) with and without hand massage on disruptive behaviour in people with dementia living in long-term care. In a single blinded randomised controlled trial 67 people with a diagnosis of dementia and a history of disruptive behaviour, from three long-term care facilities were recruited and randomised using a random number table into three groups: (1) Combination (aromatherapy and hand massage) (n = 22), (2) Aromatherapy (n = 23), (3) Placebo control (water spray) (n = 22). The intervention was given twice daily for six weeks. Data on residents' behaviour (CMAI) and cognition (MMSE) were collected before, during and after the intervention. Despite a downward trend in behaviours displayed not one of the interventions significantly reduced disruptive behaviour. Further large-scale placebo controlled studies are required where antipsychotic medication is controlled and a comparison of the methods of application of aromatherapy are investigated. ACTRN12612000917831.

  13. Cannabinoids in attention-deficit/hyperactivity disorder: A randomised-controlled trial.

    Science.gov (United States)

    Cooper, Ruth E; Williams, Emma; Seegobin, Seth; Tye, Charlotte; Kuntsi, Jonna; Asherson, Philip

    2017-08-01

    Adults with ADHD describe self-medicating with cannabis, with some reporting a preference for cannabis over ADHD medications. A small number of psychiatrists in the US prescribe cannabis medication for ADHD, despite there being no evidence from randomised controlled studies. The EMA-C trial (Experimental Medicine in ADHD-Cannabinoids) was a pilot randomised placebo-controlled experimental study of a cannabinoid medication, Sativex Oromucosal Spray, in 30 adults with ADHD. The primary outcome was cognitive performance and activity level using the QbTest. Secondary outcomes included ADHD and emotional lability (EL) symptoms. From 17.07.14 to 18.06.15, 30 participants were randomly assigned to the active (n=15) or placebo (n=15) group. For the primary outcome, no significant difference was found in the ITT analysis although the overall pattern of scores was such that the active group usually had scores that were better than the placebo group (Est=-0.17, 95%CI-0.40 to 0.07, p=0.16, n=15/11 active/placebo). For secondary outcomes Sativex was associated with a nominally significant improvement in hyperactivity/impulsivity (p=0.03) and a cognitive measure of inhibition (p=0.05), and a trend towards improvement for inattention (p=0.10) and EL (p=0.11). Per-protocol effects were higher. Results did not meet significance following adjustment for multiple testing. One serious (muscular seizures/spasms) and three mild adverse events occurred in the active group and one serious (cardiovascular problems) adverse event in the placebo group. Adults with ADHD may represent a subgroup of individuals who experience a reduction of symptoms and no cognitive impairments following cannabinoid use. While not definitive, this study provides preliminary evidence supporting the self-medication theory of cannabis use in ADHD and the need for further studies of the endocannabinoid system in ADHD. Copyright © 2017 Elsevier B.V. and ECNP. All rights reserved.

  14. A randomised controlled trial on whether a participatory ergonomics intervention could prevent musculoskeletal disorders.

    Science.gov (United States)

    Haukka, E; Leino-Arjas, P; Viikari-Juntura, E; Takala, E-P; Malmivaara, A; Hopsu, L; Mutanen, P; Ketola, R; Virtanen, T; Pehkonen, I; Holtari-Leino, M; Nykänen, J; Stenholm, S; Nykyri, E; Riihimäki, H

    2008-12-01

    To examine the efficacy of a participatory ergonomics intervention in preventing musculoskeletal disorders among kitchen workers. Participatory ergonomics is commonly recommended to reduce musculoskeletal disorders, but evidence for its effectiveness is sparse. A cluster randomised controlled trial among the 504 workers of 119 kitchens in Finland was conducted during 2002-2005. Kitchens were randomised to an intervention (n = 59) and control (n = 60) group. The duration of the intervention that guided the workers to identify strenuous work tasks and to seek solutions for decreasing physical and mental workload, was 11 to 14 months. In total, 402 ergonomic changes were implemented. The main outcome measures were the occurrence of and trouble caused by musculoskeletal pain in seven anatomical sites, local fatigue after work, and sick leave due to musculoskeletal disorders. Individual level data were collected by a questionnaire at baseline and every 3 months during the intervention and 1-year follow-up period. All response rates exceeded 92%. No systematic differences in any outcome variable were found between the intervention and control groups during the intervention or during the 1-year follow-up. The intervention did not reduce perceived physical work load and no evidence was found for the efficacy of the intervention in preventing musculoskeletal disorders among kitchen workers. It may be that a more comprehensive redesign of work organisation and processes is needed, taking more account of workers' physical and mental resources.

  15. Verificación de la contaminación del maíz por flatoxina B1

    Directory of Open Access Journals (Sweden)

    Lisa Vallone

    2010-10-01

    Full Text Available “Aflaflesh” es un instrumento computarizado, diseñado para combinar un metodo de adquisición de datos visuales, con sofisticados sistemas operativosde software y análisis de imágenes. Esto, mediante la exposicion de la fluorescencia de maíz sometido a la radiación UV, ya que si hay contaminación con aflatoxinas B1, es posible transformar directamente el número de pixeles de la fluorescencia, en la concentración de AFB1 correspondiente.

  16. Relationship between Long Chain n-3 Polyunsaturated Fatty Acids and Autism Spectrum Disorder: Systematic Review and Meta-Analysis of Case-Control and Randomised Controlled Trials

    Directory of Open Access Journals (Sweden)

    Hajar Mazahery

    2017-02-01

    Full Text Available Omega-3 long chain polyunsaturated fatty acid supplementation (n-3 LCPUFA for treatment of Autism Spectrum Disorder (ASD is popular. The results of previous systematic reviews and meta-analyses of n-3 LCPUFA supplementation on ASD outcomes were inconclusive. Two meta-analyses were conducted; meta-analysis 1 compared blood levels of LCPUFA and their ratios arachidonic acid (ARA to docosahexaenoic acid (DHA, ARA to eicosapentaenoic acid (EPA, or total n-6 to total n-3 LCPUFA in ASD to those of typically developing individuals (with no neurodevelopmental disorders, and meta-analysis 2 compared the effects of n-3 LCPUFA supplementation to placebo on symptoms of ASD. Case-control studies and randomised controlled trials (RCTs were identified searching electronic databases up to May, 2016. Mean differences were pooled and analysed using inverse variance models. Heterogeneity was assessed using I2 statistic. Fifteen case-control studies (n = 1193 were reviewed. Compared with typically developed, ASD populations had lower DHA (−2.14 [95% CI −3.22 to −1.07]; p < 0.0001; I2 = 97%, EPA (−0.72 [95% CI −1.25 to −0.18]; p = 0.008; I2 = 88%, and ARA (−0.83 [95% CI, −1.48 to −0.17]; p = 0.01; I2 = 96% and higher total n-6 LCPUFA to n-3 LCPUFA ratio (0.42 [95% CI 0.06 to 0.78]; p = 0.02; I2 = 74%. Four RCTs were included in meta-analysis 2 (n = 107. Compared with placebo, n-3 LCPUFA improved social interaction (−1.96 [95% CI −3.5 to −0.34]; p = 0.02; I2 = 0 and repetitive and restricted interests and behaviours (−1.08 [95% CI −2.17 to −0.01]; p = 0.05; I2 = 0. Populations with ASD have lower n-3 LCPUFA status and n-3 LCPUFA supplementation can potentially improve some ASD symptoms. Further research with large sample size and adequate study duration is warranted to confirm the efficacy of n-3 LCPUFA.

  17. BTS randomised feasibility study of active symptom control with or without chemotherapy in malignant pleural mesothelioma: ISRCTN 54469112.

    Science.gov (United States)

    Muers, M F; Rudd, R M; O'Brien, M E R; Qian, W; Hodson, A; Parmar, M K B; Girling, D J

    2004-02-01

    The incidence of mesothelioma is rising rapidly in the UK. There is no generally accepted standard treatment. The BTS recommends active symptom control (ASC). It is not known whether chemotherapy in addition prolongs survival or provides worthwhile palliation with acceptable toxicity. Palliation as recorded by patients has been fully reported for only two regimens: mitomycin, vinblastine, and cisplatin (MVP), and vinorelbine (N). The BTS and collaborators planned to conduct a phase III randomised trial comparing ASC only, ASC+MVP, and ASC+N in 840 patients with survival as the primary outcome measure. The aim of the present study was to assess the acceptability of the trial design to patients and the suitability of two standard quality of life (QL) questionnaires for mesothelioma. Collaborating centres registered all new patients with mesothelioma. Those eligible and giving informed consent completed EORTC QLQ-C30+LC13 and FACT-L QL questionnaires and were randomised between all three or any two of (1) ASC only, (2) ASC+4 cycles of MVP, and (3) ASC+12 weekly doses of N. During 1 year, 242 patients were registered of whom 109 (45%) were randomised (55% of the 197 eligible patients). Fifty two patients from 20 centres were randomised to an option including ASC only. This translates into a rate of 312 per year from 60 centres interested in collaborating in the phase III trial. The EORTC QL questionnaire was superior to FACT-L in terms of completeness of data and patient preference. Clinically relevant palliation was achieved with ASC. The planned phase III trial is feasible.

  18. Methodological considerations for a randomised controlled trial of podiatry care in rheumatoid arthritis: lessons from an exploratory trial

    Directory of Open Access Journals (Sweden)

    Helliwell Philip S

    2007-11-01

    Full Text Available Abstract Background Whilst evidence exists to support the use of single treatments such as orthoses and footwear, the effectiveness of podiatry-led care as a complex intervention for patients with rheumatoid arthritis (RA related foot problems is unknown. The aim of this study was to undertake an exploratory randomised controlled parallel arm clinical trial (RheumAFooT to inform the design and implementation of a definitive trial and to understand the potential benefits of this care. Methods Patients with a definite diagnosis of RA, stable drug management 3 months prior to entry, and a current history of foot problems (pain, deformity, stiffness, skin or nail lesions, or footwear problems were recruited from a hospital outpatient rheumatology clinic and randomised to receive 12 months of podiatry treatment or no care. The primary outcome was change in foot health status using the impairment/footwear (LFISIF and activity limitation/participation restriction (LFISAP subscales of the Leeds Foot Impact Scale. Disease Activity Score (DAS, Health Assessment Questionnaire (HAQ score and walking speed (m/s were also recorded. Results Of the 80 patients identified, 64 patients were eligible to participate in the pilot and 34 were recruited. 16 patients were randomised to receive podiatry led foot care and 18 received no care. Against a backdrop of stable disease (DAS and HAQ scores, there was a statistically significant between group difference in the change in foot health status for foot impairment (LFISIF but not activity/participation (LFISAP or function (walking speed over 12 months. In the podiatry arm, 1 patient declined treatment following randomisation (did not want additional hospital visits and 3 self-withdrew (lost to follow-up. Patients received an average of 3 consultations for assessment and treatment comprising routine care for skin and nail lesions (n = 3, foot orthoses (n = 9, footwear referral to the orthotist (n = 5, and ultrasound

  19. Evaluation of homoeopathic treatment in polycystic ovary syndrome: A single-blind, randomised, placebo-controlled pilot study

    Directory of Open Access Journals (Sweden)

    Chetna Deep Lamba

    2018-01-01

    Full Text Available Background and Objectives: This study was conducted with the primary objective of evaluating efficacy of Homoeopathy in establishing the menstrual regularity with improvement in either ultrasonological findings or hirsutism/acne. The quality of life was also assessed using polycystic ovary syndrome questionnaire (PCOSQ. Materials and Methods: A single-blind, randomised, placebo-controlled pilot study was conducted from February 2014 to May 2015 at two research centres. The cases fulfilling the eligibility criteria were enrolled (n = 60 and randomised to either the homoeopathic intervention (HI (n = 30 or identical placebo (P (n = 30 with uniform lifestyle modification (LSM for 6 months. Results: The menstrual regularity with improvement in other signs/symptoms was observed in 60% of the cases (n = 18 in HI + LSM group and none (n = 0 in control group (P = 0.001. Statistically significant difference (P = 0.016 was observed in reduction of intermenstrual duration (from 76.1 ± 37.7 to 46.6 ± 38.7 days in HI + LSM in comparison to placebo + LSM group (from 93.0 ± 65.2 to 93.9 ± 96.2 days. In PCOSQ, also, significant improvement was observed in HI group in domains of weight, fertility, emotions and menstrual problems (P < 0.05 with no difference in body hair (P = 0.708. No change was observed in respect of improvement in the ultrasound findings. Pulsatilla was the most frequently indicated medicine (n = 12, 40%. Conclusion: HI along with LSM has shown promising outcome; further comparative study with standard conventional treatment on adequate sample size is desirable.

  20. Preventing Weight Gain in Women in Rural Communities: A Cluster Randomised Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Catherine Lombard

    2016-01-01

    Full Text Available Obesity is reaching epidemic proportions in both developed and developing countries. Even modest weight gain increases the risk for chronic illness, yet evidence-based interventions to prevent weight gain are rare. This trial will determine if a simple low-intensity intervention can prevent weight gain in women compared to general health information.We conducted a 1-yr pragmatic, cluster randomised controlled trial in 41 Australian towns (clusters randomised using a computer-generated randomisation list for intervention (n = 21 or control (n = 20. Women aged 18 to 50 yr were recruited from the general population to receive a 1-yr self-management lifestyle intervention (HeLP-her consisting of one group session, monthly SMS text messages, one phone coaching session, and a program manual, or to a control group receiving one general women's health education session. From October 2012 to April 2014 we studied 649 women, mean age 39.6 yr (+/- SD 6.7 and BMI of 28.8 kg/m(2 (+/- SD 6.9 with the primary outcome weight change between groups at 1 yr. The mean change in the control was +0.44 kg (95% CI -0.09 to 0.97 and in the intervention group -0.48 kg (95% CI -0.99 to 0.03 with an unadjusted between group difference of -0.92 kg (95% CI -1.67 to -0.16 or -0.87 kg (95% CI -1.62 to -0.13 adjusted for baseline values and clustering. Secondary outcomes included improved diet quality and greater self-management behaviours. The intervention appeared to be equally efficacious across all age, BMI, income, and education subgroups. Loss to follow-up included 23.8% in the intervention group and 21.8% in the control group and was within the anticipated range. Limitations include lack of sensitive tools to measure the small changes to energy intake and physical activity. Those who gained weight may have been less inclined to return for 1 yr weight measures.A low intensity lifestyle program can prevent the persistent weight gain observed in women. Key features included

  1. Valor Comparativo entre la Yuca y el Maíz en la Alimentación de Cerdos

    Directory of Open Access Journals (Sweden)

    Rodolfo Mejía Tomás

    1960-12-01

    Full Text Available 1-Se utilizaron 3 grupos de 7 cerdos cada uno en ensayos comparativos entre la yuca y el maíz. La yuca formó el 40% de la ración N° 1; la ración N° 2 tuvo 20% de yuca y 20% de maíz, y la N° 3, 40% de maíz. El 60% restante en todas las raciones estuvo constituido por harina de maíz (20%, salvado de trigo (9%, torta de ajonjolí (15 %, harina de pescado (5 %, torta de algodón (10% y minersal (1 %. A cada tonelada de alimento se le adicionó 1 libra de Aurofac. El experimento fue llevado a cabo en las porquerizas de la Facultad Nacional de Agronomía, localizadas en el Valle de Medellín (1.540 metros sobre el nivel del mar y 21 °C. de temperatura media. 2-Los cerdos se pesaron con intervalos de 14 días. a una misma hora y antes de que recibieron alimento. 3 -La ración N° 1 (con 40% de yuca superó a la ración N° 2 (20% de yuca y 20% de maíz y a la N° 3 (con 40% de maíz en el levante y engorde de cerdos. 4 -La ganancia diaria fue muy variable durante todo el experimento, pero al final fueron (en promedio de 0.607 kilos en el lote N°1, 0.544 en el N° 2 y 0.527 en el tercero, que correspondían a las raciones 1, 2 y 3 respectivamente. 5 -El consumo de alimento fue más o menos igual en todos los lotes. 6 -Los cerdos alimentados con la ración N°1 tuvieron una eficiencia de 4.63: 1; los de los números 2 y 3 de 5.19: 1 y 5.29: 1 respectivamente.

  2. Effect on return to work or education of Individual Placement and Support modified for people with mood and anxiety disorders: results of a randomised clinical trial.

    Science.gov (United States)

    Hellström, Lone; Bech, Per; Hjorthøj, Carsten; Nordentoft, Merete; Lindschou, Jane; Eplov, Lene Falgaard

    2017-10-01

    The effect of Individual Placement and Support (IPS) on return to work or education among people with mood or anxiety disorders is unclear, while IPS increases return to work for people with severe mental illness. We examined the effect of IPS modified for people with mood and anxiety disorders (IPS-MA) on return to work and education compared with services as usual (SAU). In a randomised clinical superiority trial, 326 participants with mood and anxiety disorders were centrally randomised to IPS-MA, consisting of individual mentor support and career counselling (n=162) or SAU (n=164). The primary outcome was competitive employment or education at 24 months, while weeks of competitive employment or education, illness symptoms and level of functioning, and well-being were secondary outcomes. After 24 months, 44.4% (72/162) of the participants receiving IPS-MA had returned to work or education compared with 37.8% (62/164) following SAU (OR=1.34, 95% CI: 0.86 to 2.10, p=0.20). We found no difference in mean number of weeks in employment or education (IPS-MA 32.4 weeks vs SAU 26.7 weeks, p=0.14), level of depression (Hamilton Depression 6-Item Scale score IPS-MA 5.7 points vs SAU 5.0 points, p=0.12), level of anxiety (Hamilton Anxiety 6-Item Scale score IPS-MA 5.8 points vs SAU 5.1 points, p=0.17), level of functioning (Global Assessment of Functioning IPS-MA 59.1 points vs SAU 59.5 points, p=0.81) or well-being measured by WHO-Five Well-being Index (IPS-MA 49.6 points vs SAU 48.5 points, p=0.83) at 24 months. The modified version of IPS, IPS-MA, was not superior to SAU in supporting people with mood or anxiety disorders in return to work at 24 months. NCT01721824. © 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.

  3. A randomised controlled trial of complete denture impression materials.

    Science.gov (United States)

    Hyde, T P; Craddock, H L; Gray, J C; Pavitt, S H; Hulme, C; Godfrey, M; Fernandez, C; Navarro-Coy, N; Dillon, S; Wright, J; Brown, S; Dukanovic, G; Brunton, P A

    2014-08-01

    There is continuing demand for non-implant prosthodontic treatment and yet there is a paucity of high quality Randomised Controlled Trial (RCT) evidence for best practice. The aim of this research was to provide evidence for best practice in prosthodontic impressions by comparing two impression materials in a double-blind, randomised, crossover, controlled, clinical trial. Eighty-five patients were recruited, using published eligibility criteria, to the trial at Leeds Dental Institute, UK. Each patient received two sets of dentures; made using either alginate or silicone impressions. Randomisations determined the order of assessment and order of impressions. The primary outcome was patient blinded preference for unadjusted dentures. Secondary outcomes were patient preference for the adjusted dentures, rating of comfort, stability and chewing efficiency, experience of each impression, and an OHIP-EDENT questionnaire. Seventy-eight (91.8%) patients completed the primary assessment. 53(67.9%) patients preferred dentures made from silicone impressions while 14(17.9%) preferred alginate impressions. 4(5.1%) patients found both dentures equally satisfactory and 7 (9.0%) found both equally unsatisfactory. There was a 50% difference in preference rates (in favour of silicone) (95%CI 32.7-67.3%, pUnilever Hatton Award of the International Assocation for Dental Research, Capetown, South Africa, June 2014. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

  4. Drug therapy for improving walking distance in intermittent claudication: a systematic review and meta-analysis of robust randomised controlled studies

    DEFF Research Database (Denmark)

    Momsen, A H; Jensen, Martin Bach; Norager, C B

    2009-01-01

    of the databases to February 2009. In addition, reference lists were manually searched. REVIEW METHODS: Based upon a power calculation, only robust (n>56), peer-reviewed, double-blinded, randomised and placebo-controlled trials were included. The main outcomes evaluated were maximal walking distance (MWD) and pain...

  5. A pragmatic, multicentre, randomised controlled trial comparing stapled haemorrhoidopexy to traditional excisional surgery for haemorrhoidal disease (eTHoS): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Watson, Angus J M; Bruhn, Hanne; MacLeod, Kathleen; McDonald, Alison; McPherson, Gladys; Kilonzo, Mary; Norrie, John; Loudon, Malcolm A; McCormack, Kirsty; Buckley, Brian; Brown, Steven; Curran, Finlay; Jayne, David; Rajagopal, Ramesh; Cook, Jonathan A

    2014-11-11

    Current interventions for haemorrhoidal disease include traditional haemorrhoidectomy (TH) and stapled haemorrhoidopexy (SH) surgery. However, uncertainty remains as to how they compare from a clinical, quality of life (QoL) and economic perspective. The study is therefore designed to determine whether SH is more effective and more cost-effective, compared with TH. eTHoS (either Traditional Haemorrhoidectomy or Stapled Haemorrhoidopexy for Haemorrhoidal Disease) is a pragmatic, multicentre, randomised controlled trial. Currently, 29 secondary care centres are open to recruitment. Patients, aged 18 year or older, with circumferential haemorrhoids grade II to IV, are eligible to take part. The primary clinical and economic outcomes are QoL profile (area under the curve derived from the EuroQol Group's 5 Dimension Health Status Questionnaire (EQ-5D) at all assessment points) and incremental cost per quality adjusted life year (QALY) based on the responses to the EQ-5D at 24 months. The secondary outcomes include a comparison of the SF-36 scores, pain and symptoms sub-domains, disease recurrence, complication rates and direct and indirect costs to the National Health Service (NHS). A sample size of n =338 per group has been calculated to provide 90% power to detect a difference in the mean area under the curve (AUC) of 0.25 standard deviations derived from EQ-5D score measurements, with a two-sided significance level of 5%. Allowing for non-response, 400 participants will be randomised per group. Randomisation will utilise a minimisation algorithm that incorporates centre, grade of haemorrhoidal disease, baseline EQ-5D score and gender. Blinding of participants and outcome assessors is not attempted. This is one of the largest trials of its kind. In the United Kingdom alone, 29,000 operations for haemorrhoidal disease are done annually. The trial is therefore designed to give robust evidence on which clinicians and health service managers can base management decisions

  6. PREvention STudy On preventing or reducing disability from musculoskeletal complaints in music school students (PRESTO): protocol of a randomised controlled trial.

    Science.gov (United States)

    Baadjou, Vera A E; Verbunt, Jeanine A M C F; Eijsden-Besseling, Marjon D F van; Samama-Polak, Ans L W; Bie, Rob A D E; Smeets, Rob J E M

    2014-12-01

    Up to 87% of professional musicians develop work-related complaints of the musculoskeletal system during their careers. Music school students are at specific risk for developing musculoskeletal complaints and disabilities. This study aims to evaluate the effectiveness of a biopsychosocial prevention program to prevent or reduce disabilities from playing-related musculoskeletal disorders. Secondary objectives are evaluation of cost-effectiveness and feasibility. Healthy, first or second year students (n=150) will be asked to participate in a multicentre, single-blinded, parallel-group randomised controlled trial. Students randomised to the intervention group (n=75) will participate in a biopsychosocial prevention program that addresses playing-related health problems and provides postural training according to the Mensendieck or Cesar methods of postural exercise therapy, while incorporating aspects from behavioural change theories. A control group (n=75) will participate in a program that stimulates a healthy physical activity level using a pedometer, which conforms to international recommendations. No long-term effects are expected from this control intervention. Total follow-up duration is two years. The primary outcome measure is disability (Disabilities of Arm, Shoulder and Hand questionnaire). The secondary outcome measures are pain, quality of life and changes in health behaviour. Multilevel mixed-effect logistic or linear regression analyses will be performed to analyse the effects of the program on the aforementioned outcome measurements. Furthermore, cost-effectiveness, cost-utility and feasibility will be analysed. It is believed that this is the first comprehensive randomised controlled trial on the effect and rationale of a biopsychosocial prevention program for music students. Copyright © 2014 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.

  7. Morotochoerus from Uganda (17.5 Ma and Kenyapotamus from Kenya (13-11 Ma: implications for hippopotamid origins

    Directory of Open Access Journals (Sweden)

    Pickford, M.

    2011-12-01

    Full Text Available The aim of this paper is to describe and interpret suiform teeth from Moroto, Uganda, and Ngorora, Kenya, which contribute to the debate about hippo-anthracothere-whale relationships. The early stages of hippopotamid evolution are relatively poorly known on account of the paucity of their fossil record older than 7 Ma. New specimens of Morotochoerus from Uganda reveal that it is not closely related to Hippopotamidae; the superficial resemblances of the cheek teeth to those of hippos represent convergences and not homologies. Restricted samples of Palaeopotamus ternani are available from the Middle Miocene of Kenya {Maboko, ca 16 Ma; Muruyur, ca 14.5 Ma; Fort Ternan, ca 13.7 Ma} while from the base of the late Miocene, Kenyapotamus coryndonae is known from Kenya {Ngerngerwa, ca 10.5-10 Ma; Nakali, ca 10.5 Ma; Samburu Hills, ca 9.5 Ma}, Ethiopia {Ch’orora, ca 10.5 Ma} and Tunisia {Beglia Formation ca 11-10 Ma}. The recovery of specimens of Kenyapotamus from the Ngorora Formation, Kenya, aged ca 11 Ma, is of interest because it includes well preserved teeth, including an m/3 in good condition. These specimens support the hypothesis that hippopotamids descended from palaeochoerids and not from anthracotheres.El objetivo de este trabajo es describir e interpretar los dientes suiformes de Moroto, Uganda, y Ngorora, Kenia, que contribuyen al debate sobre las relaciones hipo-anthracothere-whale. Las primeras etapas de la evolución de los hipopotámidos son relativamente poco conocidas a causa de la escasez de su registro fósil en edades superiors a los 7 Ma. Nuevos ejemplares de Morotochoerus en Uganda revelan que no están estrechamente relacionados con Hippopotamidae, las semejanzas superficiales de los dientes de la mandíbula con los de los hipopótamos representan convergencias y no homologías. Algunas muestras de Palaeopotamus ternani aparecen en el Medio Mioceno de Kenia {Maboko, ca 16 Ma; Muruyur, ca 14.5 Ma; Fort Ternan, ca 13.7 Ma

  8. Double-blind, placebo-controlled, randomised phase II trial of IH636 grape seed proanthocyanidin extract (GSPE) in patients with radiation-induced breast induration

    International Nuclear Information System (INIS)

    Brooker, Sonja; Martin, Susan; Pearson, Ann; Bagchi, Debasis; Earl, Judith; Gothard, Lone; Hall, Emma; Porter, Lucy; Yarnold, John

    2006-01-01

    Background and purpose: Tissue hardness (induration), pain and tenderness are common late adverse effects of curative radiotherapy for early breast cancer. The purpose of this study was to test the efficacy of IH636 grape seed proanthocyanidin extract (GSPE) in patients with tissue induration after high-dose radiotherapy for early breast cancer in a double-blind placebo-controlled randomised phase II trial. Patients and methods: Sixty-six eligible research volunteers with moderate or marked breast induration at a mean 10.8 years since radiotherapy for early breast cancer were randomised to active drug (n=44) or placebo (n=22). All patients were given grape seed proanthocyanidin extract (GSPE) 100 mg three times a day orally, or corresponding placebo capsules, for 6 months. The primary endpoint was percentage change in surface area (cm 2 ) of palpable breast induration measured at the skin surface 12 months after randomisation. Secondary endpoints included change in photographic breast appearance and patient self-assessment of breast hardness, pain and tenderness. Results: At 12 months post-randomisation, ≥50% reduction in surface area (cm 2 ) of breast induration was recorded in13/44 (29.5%) GSPE and 6/22 (27%) placebo group patients (NS). At 12 months post-randomisation, there was no significant difference between treatment and control groups in terms of external assessments of tissue hardness, breast appearance or patient self-assessments of breast hardness, pain or tenderness. Conclusions: The study failed to show efficacy of orally-adminstered GSPE in patients with breast induration following radiotherapy for breast cancer

  9. The effect of music therapy compared with general recreational activities in reducing agitation in people with dementia: a randomised controlled trial

    NARCIS (Netherlands)

    Vink, A.C.; Zuidersma, M.; Boersma, F.; Jonge, P. de; Zuidema, S.U.; Slaets, J.P.

    2013-01-01

    OBJECTIVE: This study aimed to compare the effects of music therapy with general recreational day activities in reducing agitation in people with dementia, residing in nursing home facilities. METHODS: In a randomised controlled design, residents with dementia (n = 94) were allocated to either music

  10. The effect of music therapy compared with general recreational activities in reducing agitation in people with dementia : a randomised controlled trial

    NARCIS (Netherlands)

    Vink, A. C.; Zuidersma, M.; Boersma, F.; de Jonge, P.; Zuidema, S. U.; Slaets, J. P. J.

    2013-01-01

    Objective This study aimed to compare the effects of music therapy with general recreational day activities in reducing agitation in people with dementia, residing in nursing home facilities. Methods In a randomised controlled design, residents with dementia (n=94) were allocated to either music

  11. Smartphone-Supported versus Full Behavioural Activation for Depression: A Randomised Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Kien Hoa Ly

    Full Text Available There is need for more cost and time effective treatments for depression. This is the first randomised controlled trial in which a blended treatment--including four face-to-face sessions and a smartphone application--was compared against a full behavioural treatment. Hence, the aim of the current paper was to examine whether a blended smartphone treatment was non-inferior to a full behavioural activation treatment for depression.This was a randomised controlled non-inferiority trial (NCT01819025 comparing a blended treatment (n=46 against a full ten-session treatment (n=47 for people suffering from major depression. Primary outcome measure was the BDI-II, that was administered at pre- and post-treatment, as well as six months after the treatment.Results showed significant improvements in both groups across time on the primary outcome measure (within-group Cohen's d=1.35; CI [-0.82, 3.52] to d=1.47; CI [-0.41, 3.35]; between group d=-0.13 CI [-2.37, 2.09] and d=-0.10 CI [-2.53, 2.33]. At the same time, the blended treatment reduced the therapist time with an average of 47%.We could not establish whether the blended treatment was non-inferior to a full BA treatment. Nevertheless, this study points to that the blended treatment approach could possibly treat nearly twice as many patients suffering from depression by using a smartphone application as add-on. More studies are needed before we can suggest that the blended treatment method is a promising cost-effective alternative to regular face-to-face treatment for depression.Cognitive Behavioral Therapy Treatment of Depression With Smartphone Support NCT01819025.

  12. 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

  13. İşitme Engelli Çocukların Konuşma Edinimi Eğitiminde Dinleme Becerilerinin Önemi

    Directory of Open Access Journals (Sweden)

    M. Cem GİRGİN

    2006-01-01

    Full Text Available Konuşma kabaca, konuşma organlarının düzenli devinimleri sonucu üretilen, anlamlı organize ses dizgeleri olarak tanımlanabilir. Dinleme ise çevreden duyulan sesleri tanıma ve özellikle konuşma seslerinin anlamlandırılmasıdır. Konuşma, insana özgü iletişim biçimleri içinde en çok kullanılan yöntemlerden biridir. Bunun yanı sıra dinleme bebeklerin anadillerini ve onun konuşma boyutunun ediniminde önemli rol oynamaktadır. Bebekler doğdukları andan itibaren çevrelerindeki sesleri algılamaya ve konuşma seslerini ayırt edebilmeye programlanmışlardır. Ancak karmaşık konuşma seslerini ve dilin kurallarını sorunsuz edinebilmeleri için dinleme becerilerinin de etkin bir biçimde gelişmesi gerekmektedir. Günümüz teknolojisi, işitme kalıntısının doğru kullanımı ve doğru eğitim yaşantıları sağlanması sonucu, işitme engelli çocukların da işiten çocuklara benzer bir biçimde anadillerini edinmelerine yardımcı olan işitme araçları geliştirmiştir. Ancak dil edinimini ve bilgi dağarcıklarını geliştirebilmek için, işiten çocuklarda bile önem taşıyan dinleme ve konuşma etkinlikleri, işitme engelli çocuklar için ise hayati bir önem taşımaktadır. Bu çalışmada dinleme becerilerinin konuşma ve dil edinimine olan önemli katkıları, bilgi edinmedeki önemi üzerinde durularak dinleme ve konuşma becerilerinin özellikle işitme engelli çocuklara kazandırılmasını kolaylaştıracak etkinlikler tartışılacaktır. Speech can be simply defined as the meaningful organization of sound sequences produced as the result of synchronized movements of speech organs. Listening can be defined as the recognition of sound heard around us and especially making sense of speech sounds. Speech is one of the most common communication tools peculiar to human beings. Speech and listening plays an important role in the acquisition of mother tongue by babies. Babies are programmed to sense

  14. Effectiveness of transcranial direct current stimulation preceding cognitive behavioural management for chronic low back pain: sham controlled double blinded randomised controlled trial.

    Science.gov (United States)

    Luedtke, Kerstin; Rushton, Alison; Wright, Christine; Jürgens, Tim; Polzer, Astrid; Mueller, Gerd; May, Arne

    2015-04-16

    To evaluate the effectiveness of transcranial direct current stimulation alone and in combination with cognitive behavioural management in patients with non-specific chronic low back pain. Double blind parallel group randomised controlled trial with six months' follow-up conducted May 2011-March 2013. Participants, physiotherapists, assessors, and analyses were blinded to group allocation. Interdisciplinary chronic pain centre. 135 participants with non-specific chronic low back pain >12 weeks were recruited from 225 patients assessed for eligibility. Participants were randomised to receive anodal (20 minutes to motor cortex at 2 mA) or sham transcranial direct current stimulation (identical electrode position, stimulator switched off after 30 seconds) for five consecutive days immediately before cognitive behavioural management (four week multidisciplinary programme of 80 hours). Two primary outcome measures of pain intensity (0-100 visual analogue scale) and disability (Oswestry disability index) were evaluated at two primary endpoints after stimulation and after cognitive behavioural management. Analyses of covariance with baseline values (pain or disability) as covariates showed that transcranial direct current stimulation was ineffective for the reduction of pain (difference between groups on visual analogue scale 1 mm (99% confidence interval -8.69 mm to 6.3 mm; P=0.68)) and disability (difference between groups 1 point (-1.73 to 1.98; P=0.86)) and did not influence the outcome of cognitive behavioural management (difference between group 3 mm (-10.32 mm to 6.73 mm); P=0.58; difference between groups on Oswestry disability index 0 point (-2.45 to 2.62); P=0.92). The stimulation was well tolerated with minimal transitory side effects. This results of this trial on the effectiveness of transcranial direct current stimulation for the reduction of pain and disability do not support its clinical use for managing non-specific chronic low back pain

  15. Evaluation of biases present in the cohort multiple randomised controlled trial design : a simulation study

    NARCIS (Netherlands)

    Candlish, Jane; Pate, Alexander; Sperrin, Matthew; Staa, Tjeerd P van

    2017-01-01

    BACKGROUND: The cohort multiple randomised controlled trial (cmRCT) design provides an opportunity to incorporate the benefits of randomisation within clinical practice; thus reducing costs, integrating electronic healthcare records, and improving external validity. This study aims to address a key

  16. The maturation of randomised controlled trials in mental health ...

    African Journals Online (AJOL)

    The aims of this paper are: (i) to give an overview of the use and maturation of randomised controlled trials (RCTs) in mental health services research, (ii) to indicate areas in which mental health may present particular challenges, and (iii) to outline necessary steps to strengthen the capacity to conduct better quality ...

  17. Randomised controlled trial of reflexology for menopausal symptoms.

    Science.gov (United States)

    Williamson, Jan; White, Adrian; Hart, Anna; Ernst, Edzard

    2002-09-01

    Clinical experience suggests that reflexology may have beneficial effects on the symptoms occurring in menopausal women, particularly psychological symptoms. This study aims to examine that effect rigorously. Randomised controlled trial with two parallel arms. School of Complementary Health in Exeter, Devon, UK. Seventy-six women, aged between 45 and 60 years, reporting menopausal symptoms. Women were randomised to receive nine sessions of either reflexology or nonspecific foot massage (control) by four qualified reflexologists given over a period of 19 weeks. The Women's Health Questionnaire (WHQ), the primary measures being the subscores for anxiety and depression. Severity (visual analogue scale, VAS) and frequency of flushes and night sweats. Mean (SD) scores for anxiety fell from 0.43 (0.29) to 0.22 (0.25) in the reflexology group and from 0.37 (0.27) to 0.27 (0.29) in the control group over the course of treatment. Mean (SD) scores for depression fell from 0.37 (0.25) to 0.20 (0.24) in the reflexology group and from 0.36 (0.23) to 0.20 (0.21) in the control (foot massage) group over the same period. For both scores there was strong evidence of a time effect (P 0.2). Similar changes were found for severity of hot flushes and night sweats. In the control group, 14/37 believed they had not received true reflexology. Foot reflexology was not shown to be more effective than non-specific foot massage in the treatment of psychological symptoms occurring during the menopause.

  18. Caracterización de la superaleación ODS MA 956 para aplicaciones biomédicas

    Directory of Open Access Journals (Sweden)

    Escudero, M. I.

    1998-05-01

    Full Text Available Since the MA 956 was proposed as a possible new biomaterial due to its good corrosion resistance values in physiological fluids a long way, still not finished, has been done. An exhaustive characterization of this alloy at room temperature has been developed. The technological objectives are well established: the possible use of this material for biomedical applications as hip or knee prostheses and as dental implants. The study was performed comparing the results of this alloy with the materials used nowadays as surgical implants, i.e., titanium alloys and polyethylene.

    Desde que la MA 956 fue propuesta como posible nuevo biomaterial en base a su buena resistencia a la corrosión frente a sueros fisiológicos, un largo camino, aún sin finalizar, se ha recorrido, en el que se ha llevado a cabo una caracterización exhaustiva de esta aleación a temperatura ambiente con fines tecnológicos bien definidos: su posible uso en aplicaciones biomédicas, bien sea como prótesis de cadera o de rodilla y para implantes dentales. Los estudios se han llevado a cabo comparando esta aleación con los materiales más comúnmente utilizados en implantes ortopédicos como aleaciones de titanio y polietileno.

  19. Effect of a participatory ergonomics intervention on psychosocial factors at work in a randomised controlled trial.

    Science.gov (United States)

    Haukka, Eija; Pehkonen, Irmeli; Leino-Arjas, Päivi; Viikari-Juntura, Eira; Takala, Esa-Pekka; Malmivaara, Antti; Hopsu, Leila; Mutanen, Pertti; Ketola, Ritva; Virtanen, Tuija; Holtari-Leino, Merja; Nykänen, Jaana; Stenholm, Sari; Ojajärvi, Anneli; Riihimäki, Hilkka

    2010-03-01

    To study the effect of a participatory ergonomics intervention on psychosocial factors among kitchen workers. A cluster randomised controlled trial. Four cities in Finland, 2002-2005. 504 workers in 119 municipal kitchens. Kitchens were randomised to intervention (n=59) and control (n=60) groups. The intervention lasted 11-14 months and was based on the workers' active participation in work analysis, planning and implementing the ergonomic changes aimed at decreasing the physical and mental workload. Mental stress, mental strenuousness of work, hurry, job satisfaction, job control, skill discretion, co-worker relationships and supervisor support. Data were collected by questionnaire at baseline, at the end of the intervention, and at a 12-month follow-up (PI(12)). At the end of the intervention, the OR of job dissatisfaction for the intervention group as compared with the control group was 3.0 (95% CI 1.1 to 8.5), of mental stress 2.3 (1.2 to 4.7) and of poor co-worker relationships 2.3 (1.0 to 5.2). At the PI(12), the OR of job dissatisfaction was 3.0 (1.2 to 7.8). Analysis of the independent and joint effects of the intervention and unconnected organisational reforms showed that adverse changes were accentuated among those with exposure to both. No favourable effects on psychosocial factors at work were found. The adverse changes were due to a joint effect of the intervention and the unconnected organisational reforms. The findings do not support the usefulness of this kind of intervention in changing unsatisfactory psychosocial working conditions.

  20. Effectiveness of a healthy lifestyle intervention for chronic low back pain: a randomised controlled trial.

    Science.gov (United States)

    Williams, Amanda; Wiggers, John; OʼBrien, Kate M; Wolfenden, Luke; Yoong, Sze Lin; Hodder, Rebecca K; Lee, Hopin; Robson, Emma K; McAuley, James H; Haskins, Robin; Kamper, Steven J; Rissel, Chris; Williams, Christopher M

    2018-06-01

    We assessed the effectiveness of a 6-month healthy lifestyle intervention, on pain intensity in patients with chronic low back pain who were overweight or obese. We conducted a pragmatic randomised controlled trial, embedded within a cohort multiple randomised controlled trial of patients on a waiting list for outpatient orthopaedic consultation at a tertiary hospital in NSW, Australia. Eligible patients with chronic low back pain (>3 months in duration) and body mass index ≥27 kg/m and education and referral to a 6-month telephone-based healthy lifestyle coaching service, or usual care. The primary outcome was pain intensity measured using an 11-point numerical rating scale, at baseline, 2 weeks, and monthly for 6 months. Data analysis was by intention-to-treat according to a prepublished analysis plan. Between May 13, 2015, and October 27, 2015, 160 patients were randomly assigned in a 1:1 ratio to the intervention or usual care. We found no difference between groups for pain intensity over 6 months (area under the curve, mean difference = 6.5, 95% confidence interval -8.0 to 21.0; P = 0.38) or any secondary outcome. In the intervention group, 41% (n = 32) of participants reported an adverse event compared with 56% (n = 45) in the control group. Our findings show that providing education and advice and telephone-based healthy lifestyle coaching did not benefit patients with low back pain who were overweight or obese, compared with usual care. The intervention did not influence the targeted healthy lifestyle behaviours proposed to improve pain in this patient group.

  1. Mobile phones as a health communication tool to improve skilled attendance at delivery in Zanzibar: a cluster-randomised controlled trial.

    Science.gov (United States)

    Lund, S; Hemed, M; Nielsen, B B; Said, A; Said, K; Makungu, M H; Rasch, V

    2012-09-01

    To examine the association between a mobile phone intervention and skilled delivery attendance in a resource-limited setting. Pragmatic cluster-randomised controlled trial with primary healthcare facilities as the unit of randomisation. Primary healthcare facilities in Zanzibar. Two thousand, five hundred and fifty pregnant women (1311 interventions and 1239 controls) who attended antenatal care at one of the selected primary healthcare facilities were included at their first antenatal care visit and followed until 42 days after delivery. All pregnant women were eligible for study participation. Twenty-four primary healthcare facilities in six districts in Zanzibar were allocated by simple randomisation to either mobile phone intervention (n = 12) or standard care (n = 12). The intervention consisted of a short messaging service (SMS) and mobile phone voucher component. Skilled delivery attendance. The mobile phone intervention was associated with an increase in skilled delivery attendance: 60% of the women in the intervention group versus 47% in the control group delivered with skilled attendance. The intervention produced a significant increase in skilled delivery attendance amongst urban women (odds ratio, 5.73; 95% confidence interval, 1.51-21.81), but did not reach rural women. The mobile phone intervention significantly increased skilled delivery attendance amongst women of urban residence. Mobile phone solutions may contribute to the saving of lives of women and their newborns and the achievement of Millennium Development Goals 4 and 5, and should be considered by maternal and child health policy makers in developing countries. © 2012 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2012 RCOG.

  2. Antiseptic mouthwash against pharyngeal Neisseria gonorrhoeae: a randomised controlled trial and an in vitro study.

    Science.gov (United States)

    Chow, Eric Pf; Howden, Benjamin P; Walker, Sandra; Lee, David; Bradshaw, Catriona S; Chen, Marcus Y; Snow, Anthony; Cook, Stuart; Fehler, Glenda; Fairley, Christopher K

    2017-03-01

    Gonorrhoea is increasing among men who have sex with men (MSM). We aimed to determine whether Listerine, a commercial mouthwash product, has an inhibitory effect against Neisseria gonorrhoeae in a randomised controlled trial (RCT) and an in vitro study, and therefore may be a potentially useful agent for gonorrhoea control. In vitro: a suspension of ∼10 8 colony forming units per mL (CFU/mL) of N. gonorrhoeae was added to a serial of dilutions (up to 1:32) of alcohol-containing Listerine mouthwashes (Cool Mint and Total Care) for 1 min. A 10 µL aliquot was spread over the surface of a gonococcal agar plate and the number of N. gonorrhoeae colonies present at each dilution was calculated. The phosphate buffered saline (PBS) was used as a control. RCT: we recruited MSM with pharyngeal gonorrhoea who returned for treatment at the Melbourne Sexual Health Centre between May 2015 and February 2016. Untreated men were randomised to rinse and gargle either Listerine Cool Mint or saline for 1 min. Pharyngeal swabs were taken before and after rinsing and gargling for culture of N. gonorrhoeae . The analysis included only men who were culture positive for N. gonorrhoeae before using the allocated solution on the day of recruitment. In vitro: Listerine mouthwashes at dilutions of up to 1:4 for 1 min resulted in significant reduction of total N. gonorrhoeae counts but PBS has no inhibitory effect against N. gonorrhoeae . RCT: a total of 196 MSM were recruited, 58 (30%) were culture positive before using the solution. After gargling the allocated solution, men in the Listerine group were significantly less likely to be culture positive on the pharyngeal surface (52%) compared with men in the saline group (84%) (p=0.013). This data suggest Listerine, significantly reduces the amount of N. gonorrhoeae on the pharyngeal surface. With daily use it may increase gonococcal clearance and have important implications for prevention strategies. ACTRN12615000716561. Published by

  3. Randomised Controlled Trial Study of the Effect of TENS and NSAID ...

    African Journals Online (AJOL)

    Randomised Controlled Trial Study of the Effect of TENS and NSAID (Opoid) Drug in the Management of Post Operative Gynaecological Pain. AAG Jimoh, LO Omokanye, GA Salaudeen, ZA Suleiman, K Durowade, EO Adewara ...

  4. Variabilidad en la distribución de semillas de maíz : una revisión

    OpenAIRE

    Agnes, Diego Wilfredo; Tourn, Mario César; Soza, Eduardo Leonardo

    2010-01-01

    p.101-121 La implementación de la agricultura de precisión ha planteado el interrogante sobre como las máquinas agrícolas aplican dosis variables de insumo, en respuesta al sitio específico. En la siembra de maíz se evalúa el desempeño de las sembradoras calificando la distribución de semillas o plantas en la línea de siembra. A estos fines se arriba por diferentes metodologías como fallos, duplicaciones y distanciamientos aceptables, referidos a una distancia entre semillas prefijada, par...

  5. A Randomised Controlled Trial of complete denture impression materials

    Science.gov (United States)

    Hyde, T.P.; Craddock, H.L.; Gray, J.C.; Pavitt, S.H.; Hulme, C.; Godfrey, M.; Fernandez, C.; Navarro-Coy, N.; Dillon, S.; Wright, J.; Brown, S.; Dukanovic, G.; Brunton, P.A.

    2014-01-01

    Objectives There is continuing demand for non-implant prosthodontic treatment and yet there is a paucity of high quality Randomised Controlled Trial (RCT) evidence for best practice. The aim of this research was to provide evidence for best practice in prosthodontic impressions by comparing two impression materials in a double-blind, randomised, crossover, controlled, clinical trial. Methods Eighty-five patients were recruited, using published eligibility criteria, to the trial at Leeds Dental Institute, UK. Each patient received two sets of dentures; made using either alginate or silicone impressions. Randomisations determined the order of assessment and order of impressions. The primary outcome was patient blinded preference for unadjusted dentures. Secondary outcomes were patient preference for the adjusted dentures, rating of comfort, stability and chewing efficiency, experience of each impression, and an OHIP-EDENT questionnaire. Results Seventy-eight (91.8%) patients completed the primary assessment. 53(67.9%) patients preferred dentures made from silicone impressions while 14(17.9%) preferred alginate impressions. 4(5.1%) patients found both dentures equally satisfactory and 7 (9.0%) found both equally unsatisfactory. There was a 50% difference in preference rates (in favour of silicone) (95%CI 32.7–67.3%, p alginate as their material of choice for secondary impressions for complete dentures. Trial Registration: ISRCTN 01528038.

 This article forms part of a project for which the author (TPH) won the Senior Clinical Unilever Hatton Award of the International Assocation for Dental Research, Capetown, South Africa, June 2014. PMID:24995473

  6. Group art therapy as an adjunctive treatment for people with schizophrenia: a randomised controlled trial (MATISSE).

    OpenAIRE

    Crawford, MJ; Killaspy, H; Barnes, TR; Barrett, B; Byford, S; Clayton, K; Dinsmore, J; Floyd, S; Hoadley, A; Johnson, T; Kalaitzaki, E; King, M; Leurent, B; Maratos, A; O'Neill, FA

    2012-01-01

    OBJECTIVE To examine the clinical effectiveness and cost-effectiveness of referral to group art therapy plus standard care, compared with referral to an activity group plus standard care and standard care alone, among people with schizophrenia. DESIGN A three-arm, parallel group, single-blind, pragmatic, randomised controlled trial. Participants were randomised via an independent and remote telephone randomisation service using permuted blocks, stratified by study centre. SETTING Study partic...

  7. Randomised controlled trial of the efficacy of misoprostol used as a ...

    African Journals Online (AJOL)

    Randomised controlled trial of the efficacy of misoprostol used as a cervical ripening agent prior to termination of pregnancy in the first trimester. Eric T M de Jonge, Rachel Jewkes, Jonathan Levin, Helen Rees ...

  8. A randomised controlled trial of early initiation of oral feeding after ...

    African Journals Online (AJOL)

    A randomised controlled trial of early initiation of oral feeding after Caesarean ... The outcome measures were rate of ileus symptoms, post operative presence of ... more rapid recovery and expressed their interest in earlier hospital discharge.

  9. Periodic modulations controlling Kuznetsov–Ma soliton formation in nonlinear Schrödinger equations

    Energy Technology Data Exchange (ETDEWEB)

    Tiofack, C.G.L., E-mail: glatchio@yahoo.fr [Univ. Lille, CNRS, UMR 8523 – PhLAM – Physique des Lasers Atomes et Molécules, F-59000 Lille (France); Coulibaly, S.; Taki, M. [Univ. Lille, CNRS, UMR 8523 – PhLAM – Physique des Lasers Atomes et Molécules, F-59000 Lille (France); De Bièvre, S.; Dujardin, G. [Univ. Lille, CNRS, UMR 8524 – Laboratoire Paul Painlevé, F-59000 Lille (France); Équipe-Projet Mephysto, INRIA Lille-Nord Europe (France)

    2017-06-28

    We analyze the exact Kuznetsov–Ma soliton solution of the one-dimensional nonlinear Schrödinger equation in the presence of periodic modulations satisfying an integrability condition. We show that, in contrast to the case without modulation, the Kuznetsov–Ma soliton develops multiple compression points whose number, shape and position are controlled both by the intensity of the modulation and by its frequency. In addition, when this modulation frequency is a rational multiple of the natural frequency of the Kuznetsov–Ma soliton, a scenario similar to a nonlinear resonance is obtained: in this case the spatial oscillations of the Kuznetsov–Ma soliton's intensity are periodic. When the ratio of the two frequencies is irrational, the soliton's intensity is a quasiperiodic function. A striking and important result of our analysis is the possibility to suppress any component of the output spectrum of the Kuznetsov–Ma soliton by a judicious choice of the amplitude and frequency of the modulation. - Highlights: • Exact Kuznetsov–Ma soliton solution in presence of periodic coefficients is obtained. • The multiple compression points of the solution are studied. • The quasi-periodicity of the solution is discussed. • The possibility to suppress any component of the spectrum is analyzed.

  10. Two parallel, pragmatic, UK multicentre, randomised controlled trials comparing surgical options for upper compartment (vault or uterine) pelvic organ prolapse (the VUE Study): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Glazener, Cathryn; Constable, Lynda; Hemming, Christine; Breeman, Suzanne; Elders, Andrew; Cooper, Kevin; Freeman, Robert; Smith, Anthony R B; Hagen, Suzanne; McDonald, Alison; McPherson, Gladys; Montgomery, Isobel; Kilonzo, Mary; Boyers, Dwayne; Goulao, Beatriz; Norrie, John

    2016-09-08

    One in three women who have a prolapse operation will go on to have another operation, though not necessarily in the same compartment. Surgery can result in greater impairment of quality of life than the original prolapse itself (such as the development of new-onset urinary incontinence, or prolapse at a different site). Anterior and posterior prolapse surgery is most common (90 % of operations), but around 43 % of women also have a uterine (34 %) or vault (9 %) procedure at the same time. There is not enough evidence from randomised controlled trials (RCTs) to guide management of vault or uterine prolapse. The Vault or Uterine prolapse surgery Evaluation (VUE) study aims to assess the surgical management of upper compartment pelvic organ prolapse (POP) in terms of clinical effectiveness, cost-effectiveness and adverse events. VUE is two parallel, pragmatic, UK multicentre, RCTs (Uterine Trial and Vault Trial). Eligible for inclusion are women with vault or uterine prolapse: requiring a surgical procedure, suitable for randomisation and willing to be randomised. Randomisation will be computer-allocated separately for each trial, minimised on: requiring concomitant anterior and/or posterior POP surgery or not, concomitant incontinence surgery or not, age (under 60 years or 60 years and older) and surgeon. Participants will be randomly assigned, with equal probability to intervention or control arms in either the Uterine Trial or the Vault Trial. Uterine Trial participants will receive either a vaginal hysterectomy or a uterine preservation procedure. Vault Trial participants will receive either a vaginal sacrospinous fixation or an abdominal sacrocolpopexy. Participants will be followed up by postal questionnaires (6 months post surgery and 12 months post randomisation) and also reviewed in clinic 12 months post surgery. The primary outcome is the participant-reported Pelvic Organ Prolapse Symptom Score (POP-SS) at 12 months post randomisation

  11. Does hospital at home for palliative care facilitate death at home? Randomised controlled trial

    Science.gov (United States)

    Grande, Gunn E; Todd, Chris J; Barclay, Stephen I G; Farquhar, Morag C

    1999-01-01

    Objective To evaluate the impact on place of death of a hospital at home service for palliative care. Design Pragmatic randomised controlled trial. Setting Former Cambridge health district. Participants 229 patients referred to the hospital at home service; 43 randomised to control group (standard care), 186 randomised to hospital at home. Intervention Hospital at home versus standard care. Main outcome measures Place of death. Results Twenty five (58%) control patients died at home compared with 124 (67%) patients allocated to hospital at home. This difference was not significant; intention to treat analysis did not show that hospital at home increased the number of deaths at home. Seventy three patients randomised to hospital at home were not admitted to the service. Patients admitted to hospital at home were significantly more likely to die at home (88/113; 78%) than control patients. It is not possible to determine whether this was due to hospital at home itself or other characteristics of the patients admitted to the service. The study attained less statistical power than initially planned. Conclusion In a locality with good provision of standard community care we could not show that hospital at home allowed more patients to die at home, although neither does the study refute this. Problems relating to recruitment, attrition, and the vulnerability of the patient group make randomised controlled trials in palliative care difficult. While these difficulties have to be recognised they are not insurmountable with the appropriate resourcing and setting. Key messagesTerminally ill patients allocated to hospital at home were no more likely to die at home than patients receiving standard careAlthough the subsample of patients actually admitted to hospital at home did show a significant increase in likelihood of dying at home, whether this was due to the service itself or the characteristics of patients admitted to hospital at home could not be determinedThe need to

  12. Can topical insect repellents reduce malaria? A cluster-randomised controlled trial of the insect repellent N,N-diethyl-m-toluamide (DEET in Lao PDR.

    Directory of Open Access Journals (Sweden)

    Vanessa Chen-Hussey

    Full Text Available BACKGROUND: Mosquito vectors of malaria in Southeast Asia readily feed outdoors making malaria control through indoor insecticides such as long-lasting insecticidal nets (LLINs and indoor residual spraying more difficult. Topical insect repellents may be able to protect users from outdoor biting, thereby providing additional protection above the current best practice of LLINs. METHODS AND FINDINGS: A double blind, household randomised, placebo-controlled trial of insect repellent to reduce malaria was carried out in southern Lao PDR to determine whether the use of repellent and long-lasting insecticidal nets (LLINs could reduce malaria more than LLINs alone. A total of 1,597 households, including 7,979 participants, were recruited in June 2009 and April 2010. Equal group allocation, stratified by village, was used to randomise 795 households to a 15% DEET lotion and the remainder were given a placebo lotion. Participants, field staff and data analysts were blinded to the group assignment until data analysis had been completed. All households received new LLINs. Participants were asked to apply their lotion to exposed skin every evening and sleep under the LLINs each night. Plasmodium falciparum and P. vivax cases were actively identified by monthly rapid diagnostic tests. Intention to treat analysis found no effect from the use of repellent on malaria incidence (hazard ratio: 1.00, 95% CI: 0.99-1.01, p = 0.868. A higher socio-economic score was found to significantly decrease malaria risk (hazard ratio: 0.72, 95% CI: 0.58-0.90, p = 0.004. Women were also found to have a reduced risk of infection (hazard ratio: 0.59, 95% CI: 0.37-0.92, p = 0.020. According to protocol analysis which excluded participants using the lotions less than 90% of the time found similar results with no effect from the use of repellent. CONCLUSIONS: This randomised controlled trial suggests that topical repellents are not a suitable intervention in addition to

  13. A randomised controlled study of reflexology for the management of chronic low back pain.

    Science.gov (United States)

    Poole, Helen; Glenn, Sheila; Murphy, Peter

    2007-11-01

    The use of complementary and alternative medicine (CAM) for the management of chronic low back pain (CLBP) continues to rise. However, questions regarding the efficacy of many CAM therapies for CLBP remain unresolved. The present study investigated the effectiveness of reflexology for CLBP. A pragmatic randomised controlled trial was conducted. N=243 patients were randomised to one of three groups: reflexology, relaxation, or non-intervention (usual care). All completed a questionnaire booklet before and after the treatment phase, and at six months follow up. This measured their general health status, pain, functioning, coping strategies and mood. After adjusting for pre-treatment scores repeated measures ANCOVA found no significant differences between the groups pre and post treatment on the primary outcome measures of pain and functioning. There was a main effect of pain reduction, irrespective of group. Trends in the data illustrated the pain reduction was greatest in the reflexology group. Thus, the current study does not indicate that adding reflexology to usual GP care for the management of CLBP is any more effective than usual GP care alone.

  14. Modulation of gut microbiota dysbioses in type 2 diabetic patients by macrobiotic Ma-Pi 2 diet.

    Science.gov (United States)

    Candela, Marco; Biagi, Elena; Soverini, Matteo; Consolandi, Clarissa; Quercia, Sara; Severgnini, Marco; Peano, Clelia; Turroni, Silvia; Rampelli, Simone; Pozzilli, Paolo; Pianesi, Mario; Fallucca, Francesco; Brigidi, Patrizia

    2016-07-01

    The gut microbiota exerts a role in type 2 diabetes (T2D), and deviations from a mutualistic ecosystem layout are considered a key environmental factor contributing to the disease. Thus, the possibility of improving metabolic control in T2D by correcting gut microbiome dysbioses through diet has been evaluated. Here, we explore the potential of two different energy-restricted dietary approaches - the fibre-rich macrobiotic Ma-Pi 2 diet or a control diet recommended by Italian professional societies for T2D treatment - to correct gut microbiota dysbioses in T2D patients. In a previous 21-d open-label MADIAB trial, fifty-six overweight T2D patients were randomised to the Ma-Pi 2 or the control diet. For the present study, stools were collected before and after intervention from a subset of forty MADIAB participants, allowing us to characterise the gut microbiota by 16S rRNA sequencing and imputed metagenomics. To highlight microbiota dysbioses in T2D, the gut microbiota of thirteen normal-weight healthy controls were characterised. According to our findings, both diets were effective in modulating gut microbiome dysbioses in T2D, resulting in an increase of the ecosystem diversity and supporting the recovery of a balanced community of health-promoting SCFA producers, such as Faecalibacterium, Roseburia, Lachnospira, Bacteroides and Akkermansia. The Ma-Pi 2 diet, but not the control diet, was also effective in counteracting the increase of possible pro-inflammatory groups, such as Collinsella and Streptococcus, in the gut ecosystem, showing the potential to reverse pro-inflammatory dysbioses in T2D, and possibly explaining the greater efficacy in improving the metabolic control.

  15. ÖRGÜTLERDE ESNEK ÇALIŞMA UYGULAMALARI VE BUNA İLİŞKİN OLARAK 4857 SAYILI İŞ KANUNUNDA GETİRİLEN DÜZENLEMELERİN İNCELENMESİ

    OpenAIRE

    BOLAT, Tamer; AYTEMİZ SEYMEN, Oya; BOLAT, Oya İnci

    2006-01-01

    Son yıllarda geleneksel çalışma düzeninden farklı olarak, örgütlerde, sözleşmeler, görevler, çalışma zamanı, çalışma süresi ve mekânı açısından esnek uygulamalarla yaygın bir şekilde karşılaşılmaktadır. Bu kapsamda, esnek çalışma saatleri, kısmî süreli çalışma, iş paylaşımı, sıkıştırılmış iş haftası, vardiyalı çalışma ve uzaktan çalışma gibi uygulamalar en çok karşılaşılan esnek çalışma türleridir. Sözü edilen uygulamalardan kısmî süreli çalışma, çağrı üzerine çalışma, geçici iş ilişkisi ve s...

  16. Insecticide-treated nets for the prevention of malaria in pregnancy: a systematic review of randomised controlled trials.

    Directory of Open Access Journals (Sweden)

    Carol Gamble

    2007-03-01

    Full Text Available BACKGROUND: Protection from malaria with insecticide-treated bednets (ITNs during pregnancy is widely advocated, but evidence of benefit has been inconsistent. We undertook a systematic review of randomised trials. METHODS AND FINDINGS: Three cluster-randomised and two individually randomised trials met the inclusion criteria; four from Africa (n = 6,418 and one from Thailand (n = 223. In Africa, ITNs compared to no nets increased mean birth weight by 55 g (95% confidence interval [CI] 21-88, reduced low birth weight by 23% (relative risk [RR] 0.77, 95% CI 0.61-0.98, and reduced miscarriages/stillbirths by 33% (RR 0.67, 0.47-0.97 in the first few pregnancies. Placental parasitaemia was reduced by 23% in all gravidae (RR 0.77, 0.66-0.90. The effects were apparent in the cluster-randomised trials and the one individually randomised trial in Africa. The trial in Thailand, which randomised individuals to ITNs or untreated nets, showed reductions in anaemia and fetal loss in all gravidae, but not reductions in clinical malaria or low birth weight. CONCLUSIONS: ITNs used throughout pregnancy or from mid-pregnancy onwards have a beneficial impact on pregnancy outcome in malaria-endemic Africa in the first few pregnancies. The potential impact of ITNs in pregnant women and their newborns in malaria regions outside Africa requires further research.

  17. Psychosocial consequences in the Danish randomised controlled lung cancer screening trial (DLCST).

    Science.gov (United States)

    Rasmussen, Jakob F; Siersma, V; Pedersen, J H; Brodersen, J

    2015-01-01

    To measure the psychosocial consequences in the Danish lung cancer screening trial (DLCST) and compare those between the computed tomography (CT) group and the control group. This study was a single centre randomised controlled trial with five annual screening rounds. Healthy current or former heavy smokers aged 50-70 years (men and women) were randomised 1:1 to a CT group and a control group. Heavy smokers were defined by having smoked ≥20 pack years and former smokers by being abstinent ≤10 years. Both groups were invited annually to the screening clinic to complete the validated lung-cancer-specific questionnaire consequences of screening lung cancer (COS-LC). The CT group was also offered a low dose CT scan of the lungs. The COS-LC measures nine scales with psychosocial properties: Anxiety, Behaviour, Dejection, Negative impact on sleep, Self-blame, Focus on Airway Symptoms, Stigmatisation, Introvert, and Harm of Smoking. 4104 participants were randomised to the DLCST and the COS-LC completion rates for the CT group and the control group were 95.5% and 73.6%, respectively. There was a significant increase in negative psychosocial consequences from baseline through rounds 2-5 for both the CT group and the control group (mean increase >0, p0 and p<.033). Lung cancer CT-screening trials induced more negative psychosocial reactions in both the CT group and the control group compared with the baseline psychosocial profile. The CT group experienced less negative psychosocial consequences compared with the control group, which might be explained by reassurance among those with normal screening results. ClinicalTrials.gov: NCT00496977. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  18. Multidisciplinary diabetes care with and without bariatric surgery in overweight people: a randomised controlled trial.

    Science.gov (United States)

    Wentworth, John M; Playfair, Julie; Laurie, Cheryl; Ritchie, Matthew E; Brown, Wendy A; Burton, Paul; Shaw, Jonathan E; O'Brien, Paul E

    2014-07-01

    Bariatric surgery improves glycaemia in obese people with type 2 diabetes, but its effects are uncertain in overweight people with this disease. We aimed to identify whether laparoscopic adjustable gastric band surgery can improve glucose control in people with type 2 diabetes who were overweight but not obese. We did an open-label, parallel-group, randomised controlled trial between Nov 1, 2009, and June 30, 2013, at one centre in Melbourne, Australia. Patients aged 18-65 years with type 2 diabetes and a BMI between 25 and 30 kg/m2 were randomly assigned (1:1), by computer-generated random sequence, to receive either multidisciplinary diabetes care plus laparoscopic adjustable gastric band surgery or multidisciplinary diabetes care alone. The primary outcome was diabetes remission 2 years after randomisation, defined as glucose concentrations of less than 7.0 mmol/L when fasting and less than 11.1 mmol/L 2 h after 75 g oral glucose, at least two days after stopping glucose-lowering drugs. Analysis was by intention to treat. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12609000286246. 51 patients were randomised to the multidisciplinary care plus gastric band group (n=25) or the multidisciplinary care only group (n=26), of whom 23 participants and 25 participants, respectively, completed follow-up to 2 years. 12 (52%) participants in the multidisciplinary care plus gastric band group and two (8%) participants in the multidisciplinary care only group achieved diabetes remission (difference in proportions 0.44, 95% CI 0.17-0.71; p=0.0012). One (4%) participant in the gastric band group needed revisional surgery and four others (17%) had a total of five episodes of food intolerance due to excessive adjustment of the band. When added to multidisciplinary care, laparoscopic adjustable gastric band surgery for overweight people with type 2 diabetes improves glycaemic control with an acceptable adverse event profile

  19. Study of Optimal Replacement of Thyroxine in the Elderly (SORTED) - results from the feasibility randomised controlled trial.

    Science.gov (United States)

    Razvi, Salman; Ingoe, Lorna; Ryan, Vicky; Pearce, Simon H S; Wilkes, Scott

    2016-01-01

    Hypothyroidism is a common condition, particularly in the older population. Thyroid hormone requirements change with age and serum TSH levels also alter, especially in older patients. However, in practice laboratory reference ranges for thyroid function are not age-specific and treatment in older patients aims to achieve a similar target thyroid function level as younger age groups. A dual centre, single blind, randomised controlled trial was conducted to determine the feasibility of a future definitive RCT in hypothyroid individuals aged 80 years or older who were treated with levothyroxine. Potential participants were identified from 17 research-active GP practices ( n  = 377), by opportunistic invitations ( n  = 9) or in response to publicity ( n  = 4). Participants were randomly allocated to either usual (0.4-4.0 mU/L) or a higher (4.1-8.0 mU/L) target serum TSH range. Information on participants' willingness to enter the trial, acceptability of study design, length of time to complete recruitment and dose titration strategy was collected. Fifteen percent (57/390) of potentially eligible hypothyroid individuals consented to participate in this trial and 48 were randomised to trial medication for 24 weeks, giving a recruitment rate of 12 %. Recruitment averaged 5.5 participants per month over approximately 9 months. Eight participants withdrew (3/24 and 5/24 in the usual and higher TSH arms, respectively) with the commonest reason cited (5 patients) being tiredness. Interestingly, 3/5 participants withdrew from the site that required a visit to a Research Facility whereas only 5/43 participants withdrew from the site that offered home visits. In the higher TSH arm, of those participants who completed the study, approximately half of participants (10/19) reached target TSH. It is feasible to perform a randomised controlled trial of thyroid hormones in hypothyroid patients aged 80 or older. A definitive trial would require collaboration with a

  20. EOS-based cup navigation: Randomised controlled trial in 78 total hip arthroplasties.

    Science.gov (United States)

    Verdier, N; Billaud, A; Masquefa, T; Pallaro, J; Fabre, T; Tournier, C

    2016-06-01

    Minimising the risk of cup implantation outside the safe zone is among the objectives of navigation during total hip arthroplasty (THA). However, given the technical challenges raised by navigation when the patient is lying on the side, many surgeons still use the freehand technique. We conducted a randomised controlled trial to evaluate the new navigation system NAVEOS in the iliac plane, which is easily identified in the lateral decubitus position, with the objective of determining whether NAVEOS navigation decreased the frequency of cup implantation outside the safe zone compared to freehand cup positioning, without increasing the operative time or the frequency of complications. NAVEOS navigation decreases the frequency of cup positioning outside the safe zone compared to freehand positioning. This randomised controlled trial compared cup positioning using NAVEOS navigation versus the freehand technique in patients undergoing primary THA. The safe zone was defined according to Lewinnek as 15±10° of radiological anteversion and 40±10° of radiological inclination. Cup position parameters were measured on computed tomography images obtained 3months after THA. The images were read by two independent observers who were blinded to group assignment. The primary evaluation criterion was cup position within the safe zone. A 1:1 randomisation scheme was used to assign 78 patients (mean age, 68years; age range, 44-91years) to NAVEOS navigation or freehand cup positioning. The two groups were comparable for age, gender distribution, body mass index, and preoperative functional scores. In the NAVEOS group, navigation was discontinued prematurely in 6 patients, because of technical difficulties (n=2) or a marked discrepancy with clinical findings (n=4); however, the intention-to-treat approach was used for the analysis. The proportion of cups in the safe zone was 67% (28/39) in the NAVEOS group and 38% (17/39) in the freehand group (P=0.012). Anteversion was within the

  1. Effect of steroids on inflammatory markers and clinical parameters in congenital open heart surgery: a randomised controlled trial.

    Science.gov (United States)

    Amanullah, Muhammad M; Hamid, Mohammad; Hanif, Hashim M; Muzaffar, Marium; Siddiqui, Maria T; Adhi, Fatima; Ahmad, Khabir; Khan, Shahjahan; Hasan, Zahra

    2016-03-01

    Cardiopulmonary bypass is associated with systemic inflammatory response. Steroids suppress this response, although the therapeutic evidence remains controversial. We hypothesised that intravenous steroids in children undergoing open-heart surgery would decrease inflammation leading to better early post-operative outcomes. We conducted a randomised controlled trial to evaluate the trends in the levels of immunomodulators and their effects on clinical parameters. To assess the effects of intravenous steroids on early post-operative inflammatory markers and clinical parameters in children undergoing open-heart surgery. A randomised controlled trial involving 152 patients, from one month up to 18 years of age, who underwent open-heart surgery for congenital heart disease from April 2010-2012 was carried out. Patients were randomised and administered either three scheduled intravenous pulse doses of dexamethasone (1 mg/kg) or placebo. Blood samples were drawn at four time intervals and serum levels of inflammatory cytokines - Interleukin-6, 8, 10, 18, and tumour necrosis factor-alpha - were measured. Clinical parameters were also assessed. Blood cytokine levels were compared between the dexamethasone (n=65) and placebo (n=64) groups. Interleukin-6 levels were lower at 6 and 24 hours post-operatively (p<0.001), and Interleukin-10 levels were higher 6 hours post-operatively (p<0.001) in the steroid group. Interleukin-8, 18, and tumour necrosis factor-alpha levels did not differ between the groups at any time intervals. The clinical parameters were similar in both the groups. Dexamethasone caused quantitative suppression of Interleukin-6 and increased Interleukin-10 activation, contributing to reduced immunopathology, but it did not translate into clinical benefit in the short term.

  2. Obtención de un filtrante de maíz morado (Zea mays L.), evaluación de pérdida de color y degradación de antocianinas en el almacenaje

    OpenAIRE

    Nolazco C., Diana; Universidad Nacional Agraria la Molina, Lima, Perú.; Araujo V., Miguel; Universidad Nacional Agraria la Molina, Lima, Perú.

    2016-01-01

    El trabajo de investigación permitió obtener un filtrante de maíz morado, evaluar la pérdida del color y degradación de las antocianinas durante el almacenaje a 70, 80, 90 y 100% de humedad relativa (H.R.). Se obtuvo el filtrante de maíz morado mediante una mezcla de canela 1%, clavo de olor 1%, grano 10% y coronta de maíz morado 88%, con una tamaño de partícula entre 2 y 4mm. La caracterización del filtrante reportó: humedad 7.9%, carbohidratos 74.4%, cenizas 2.4%, grasa 0.2%, proteína 5.1%,...

  3. Apoyo social, integración y calidad de vida de la mujer inmigrante en Málaga

    OpenAIRE

    Domínguez Fuentes, Juan Manuel

    2011-01-01

    La presente tesis doctoral aborda el tema de los movimientos migratorios actuales incorporando la perspectiva de género. Para ello, se utiliza un enfoque psicosocial capaz de explicar y analizar las características de las mujeres inmigrantes en Málaga. Los objetivos que se pretenden alcanzar con esta investigación son: 1,- Analizar las características de la inmigración femenina en nuestro país, concretamente en la ciudad de Málaga. 2,- Determinar la importancia de las redes sociales e...

  4. Obtención de almidón bajo en proteínas a partir de maíz desgerminado

    Directory of Open Access Journals (Sweden)

    L. M. Medina

    2010-07-01

    Full Text Available La producción de almidones nativos bajos en proteína, a partir de maíz descascarillado y desgerminado, se realiza mediante el tratamiento de la harina con soluciones alcalinas de CuS04 y Na2 SO3. Los niveles de sales y el tiempo de tratamiento dependen del sistema de agitación utilizado.

  5. Participatory ergonomics to reduce exposure to psychosocial and physical risk factors for low back pain and neck pain: Results of a cluster randomised controlled trial

    NARCIS (Netherlands)

    Driessen, M.T.; Proper, K.I.; Anema, J.R.; Knol, D.L.; Bongers, P.M.; Beek, A.J. van der

    2011-01-01

    Objectives: This study investigated the effectiveness of the Stay@Work participatory ergonomics programme to reduce workers9 exposure to psychosocial and physical risk factors. Methods: 37 departments (n=3047 workers) from four Dutch companies participated in this cluster randomised controlled

  6. Randomised controlled trial of the effects of L-ornithine on stress markers and sleep quality in healthy workers.

    Science.gov (United States)

    Miyake, Mika; Kirisako, Takayoshi; Kokubo, Takeshi; Miura, Yutaka; Morishita, Koji; Okamura, Hisayoshi; Tsuda, Akira

    2014-06-03

    L-ornithine is a non-essential, non-protein amino acid. Although L-ornithine is contained in various foods, the amount is usually small.Recently, studies have shown that orally administered L-ornithine reduced the stress response in animals.From these findings, we speculated that L-ornithine may play a role in the relieve of stress and improve sleep and fatigue symptoms in humans. Through a randomised, double-blind, placebo-controlled clinical study, we asked if L-ornithine could be beneficial to stress and sleep in healthy workers. Fifty-two apparently healthy Japanese adults who had previously felt slight stress as well as fatigue were recruited to be study participants and were randomly divided into either the L-ornithine (400 mg/day) or placebo group. They orally consumed the respective test substance every day for 8 weeks. Serum was collected for the assessment of cortisol and dehydroepiandrosterone-sulphate (DHEA-S). Perceived mood and quality of sleep were measured by the Profile of Mood States (POMS), Athens Insomnia Scale (AIS), and Ogri-Shirakawa-Azumi sleep inventory MA version (OSA-MA). Serum cortisol levels and the cortisol/DHEA-S ratio were significantly decreased in the L-ornithine group in comparison with the placebo group. Also, anger was reduced and perceived sleep quality was improved in the L-ornithine group. L-ornithine supplementation has the potential to relieve stress and improve sleep quality related to fatigue, both objectively and subjectively.

  7. Producción de maíz y pluriactividad de los campesinos en el Valle de Puebla, México

    Directory of Open Access Journals (Sweden)

    Nemesio Osorio-García

    2015-01-01

    Full Text Available La principal actividad de los campesinos en el Valle de Puebla es la producción de maíz; sin embargo, realizan otras actividades agrícolas y no agrícolas para satisfacer sus necesidades familiares. El objetivo de esta investigación fue precisar el estado actual de la producción de maíz y su relación con la pluriactividad que desarrollan los campesinos de la zona y qué factores la determinan. Se aplicó un muestreo estadístico a 111 campesinos seleccionados al azar. Los resultados indicaron que los campesinos son minifundistas, y con bajo nivel de escolaridad. La totalidad se dedica a la producción de maíz, y utilizan variedades nativas (98.2 %. Los destinos de la producción fueron el consumo familiar, la alimentación de animales y, en menor proporción, la venta. El 41.4 % de los entrevistados realizaron actividades extrafinca, las cuales aunadas a la superficie agrícola determinaron el nivel de otras actividades agropecuarias. El factor más importante que determinó la pluriactividad fue la escolaridad de los agricultores.

  8. A Closer Look at the Pangasinan Verbal Affixes maN- and oN-

    Directory of Open Access Journals (Sweden)

    Francisco C. Rosario, Jr.

    2017-12-01

    Full Text Available The main objective of this paper is to present a simple description and discussion of the semantic and grammatical functions of the Pangasinan verbal affixes maN- and oN-. The semantic description of the functions of these Pangasinan verbal affixes was based on the meanings derived from the combination of the verbal affix and a list of compatible verb roots. Verb roots that are semantically related were also identified and classified to present an evidence that support the view that in particular semantic classes of verb roots, the root-affix correspondence is regular. The grammatical functions, on the other hand, were determined based on the type of arguments selected by the verbs, which were derived using the two verbal affixes. At least 370 verb roots were analyzed to identify the semantic and grammatical functions of these verbal affixes.

  9. Birth preference in women undergoing treatment for childbirth fear: A randomised controlled trial.

    Science.gov (United States)

    Larsson, Birgitta; Karlström, Annika; Rubertsson, Christine; Ternström, Elin; Ekdahl, Johanna; Segebladh, Birgitta; Hildingsson, Ingegerd

    2017-12-01

    Childbirth fear is the most common underlying reason for requesting a caesarean section without medical reason. The aim of this randomised controlled study was to investigate birth preferences in women undergoing treatment for childbirth fear, and to investigate birth experience and satisfaction with the allocated treatment. Pregnant women classified with childbirth fear (≥60 on the Fear Of Birth Scale) (n=258) were recruited at one university hospital and two regional hospitals over one year. The participants were randomised (1:1) to intervention (Internet-based Cognitive Behaviour Therapy (ICBT)) (n=127) or standard care (face-to-face counselling) (n=131). Data were collected by questionnaires in pregnancy week 20-25 (baseline), week 36 and two months after birth. Caesarean section preference decreased from 34% to 12% in the ICBT group and from 24% to 20% in the counselling group. Two months after birth, the preference for caesarean increased to 20% in the ICBT group and to 29% in the counselling group, and there was no statistically significant change over time. Women in the ICBT group were less satisfied with the treatment (OR 4.5). The treatment had no impact on or worsened their childbirth fear (OR 5.5). There were no differences between the groups regarding birth experience. Women's birth preferences fluctuated over the course of pregnancy and after birth regardless of treatment method. Women felt their fear was reduced and were more satisfied with face-to-face counselling compared to ICBT. A higher percentage were lost to follow-up in ICBT group suggesting a need for further research. Copyright © 2017 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.

  10. Psychological rehabilitation after myocardial infarction: multicentre randomised controlled trial.

    OpenAIRE

    Jones, D. A.; West, R. R.

    1996-01-01

    OBJECTIVE: To evaluate rehabilitation after myocardial infarction. DESIGN: Randomised controlled trial of rehabilitation in unselected myocardial infarction patients in six centres, baseline data being collected on admission and by structured interview (of patients and spouses) shortly after discharge and outcome being assessed by structured interview at six months and clinical examination at 12 months. SETTING: Six district general hospitals. SUBJECTS: All 2328 eligible patients admitted ove...

  11. Faecal short chain fatty acids in healthy subjects participating in a randomised controlled trial examining a soluble highly viscous polysaccharide versus control.

    Science.gov (United States)

    Reimer, R A; Pelletier, X; Carabin, I G; Lyon, M R; Gahler, R J; Wood, S

    2012-08-01

    Short chain fatty acids (SCFA) are produced by the bacterial fermentation of dietary fibre and have been linked with intestinal health. The present study examined faecal SCFA concentrations in subjects consuming a novel soluble highly viscous polysaccharide (HVP) or control for 3 weeks. A total of 54 healthy adults participated in a randomised, double-blind, placebo-controlled study. Subjects were randomised to consume HVP or control (skim milk powder). A dose of 5 g day(-1) was consumed in the first week, followed by 10 g day(-1) in the second and third weeks (n = 27 per group). The primary outcome was SCFA concentrations in faecal samples collected at baseline (visit 1, V1), at 1 week (V2) and at 3 week (V3). The reduction in faecal acetate from V1 to V3 in control subjects was not observed in subjects consuming HVP. There were no differences in propionate, butyrate, valerate or caproate concentrations. There was a significant treatment effect (P = 0.03) for total SCFA, with higher concentrations observed in subjects consuming HVP versus control. HVP is a viscous functional fibre that may influence gut microbial fermentation. Further work is warranted to examine the fermentative properties of HVP and possible links with appetite regulation and reduced serum low-density lipoprotein cholesterol concentrations. © 2012 The Authors. Journal of Human Nutrition and Dietetics © 2012 The British Dietetic Association Ltd.

  12. Help from home for depression: A randomised controlled trial comparing internet-delivered cognitive behaviour therapy with bibliotherapy for depression

    Directory of Open Access Journals (Sweden)

    Jessica Smith

    2017-09-01

    Full Text Available Major Depressive Disorder (MDD is a leading cause of the Global Burden of Disease. Cognitive Behavioural Therapy (CBT is an effective treatment for MDD, but access can be impaired due to numerous barriers. Internet-delivered CBT (iCBT can be utilised to overcome treatment barriers and is an effective treatment for depression, but has never been compared to bibliotherapy. This Randomised Controlled Trial (RCT included participants meeting diagnostic criteria for MDD (n = 270 being randomised to either: iCBT (n = 61, a CBT self-help book (bCBT (n = 77, a meditation self-help book (bMED (n = 64 or wait-list control (WLC (n = 68. The primary outcome was the Patient Health Questionnaire 9-item scale (PHQ-9 at 12-weeks (post-treatment. All three active interventions were significantly more effective than WLC in reducing depression at post-treatment, but there were no significant differences between the groups. All three interventions led to large within-group reductions in PHQ-9 scores at post-treatment (g = 0.88–1.69, which were maintained at 3-month follow-up, although there was some evidence of relapse in the bMED group (within-group g [post to follow-up] = 0.09–1.04. Self-help based interventions could be beneficial in treating depression, however vigilance needs to be applied when selecting from the range of materials available. Replication of this study with a larger sample is required.

  13. Assessing a cognitive music training for older participants: a randomised controlled trial.

    Science.gov (United States)

    Biasutti, Michele; Mangiacotti, Anthony

    2018-02-01

    In a randomised controlled trial, we investigated whether a cognitive training based on rhythm-music and music improvisation exercises had positive effects on executive functions in older participants. Thirty-five residents in a guest home with mild-moderate cognitive impairment and healthy ageing were randomly assigned to an experimental group (n = 18) featuring cognitive music training composed of 12 bi-weekly 70-min sessions, and a control group (n = 17) attended 12 bi-weekly 45-min sessions of gymnastic activities offered by the institute. A neuropsychological test battery was administered at baseline and at the end of treatment, including the Mini-Mental State Examination, verbal fluency test, Trail Making Test A, attentional matrices test and clock-drawing test. Pre-test and post-test comparison showed a significant improvement for the experimental group reflected in the Mini-Mental State Examination (F(1,33) = 13.906; p music-rhythmic exercises and music improvisation exercises is associated with improved cognitive functions in older people with mild-moderate cognitive impairment regardless of the individual's degree of cognitive reserve. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

  14. Fertilidad y extracción de nutrientes en la asociación maíz-pastos en suelos ácidos del piedemonte Llanero de Colombia

    Directory of Open Access Journals (Sweden)

    Rincón Álvaro

    2008-08-01

    Full Text Available

    En un oxisol del Centro de Investigaciones La Libertad de Corpoica, a 17 km de Villavicencio, se estableció la asociación de maíz con los pastos B. decumbens, Mulato 1 y Toledo, como medio para recobrar la productividad de una pradera degradada. Los minerales aplicados 45 días antes de la siembra fueron: Ca, 555 kg ha-1; Mg, 88 kg ha-1; P, 35 kg ha-1 y S, 45 kg ha- 1, utilizando como fuente cal dolomítica, roca fosfórica y yeso agrícola; al momento de la siembra se aplicaron: 31 kg ha-1 de P, 27 de N (fuente fosfato diamónico; 37,5 de K (fuente cloruro de potasio; 3 de Zn; 0,1 de Cu; 0,5 de B y 1,2 de S (fuente borozinco. A los 15 después de la siembra (dds se aplicaron 37,5 kg ha-1 de K. La aplicación de N se fraccionó en dosis de 100 y 200 kg ha-1 a los 15 y 35 dds, respectivamente. Los análisis de suelos realizados después de la cosecha del maíz demostraron un mejoramiento de la fertilidad, ya que la saturación de bases aumentó de 24% inicial a 47%, el P disponible pasó de 2 ppm a 11,8 ppm, el S aumentó de 3 ppm a 6 ppm. En el momento de la cosecha, la mayor extracción de N fue la hicieron el grano de maíz y los pastos (43 y 45 kg ha-1, respectivamente, mientras que el P se presentó en mayor concentración en el grano de maíz (12,7 kg ha-1. Los pastos y la soca de maíz (tallos y hojas después de la cosecha se caracterizaron por un mayor contenido de K (40 y 27 kg ha-1, respectivamente. El Ca, Mg y S fueron más extraídos por los pastos (9; 8 y 6 kg ha-1, respectivamente; los minerales extraídos en mayor cantidad por el maíz y los pastos fueron N (91%, P (57% y K (58%, mientras que los de menor extracción fueron Ca (2,2% y Mg (16%.

  15. Ciprofloxacin DPI: a randomised, placebo-controlled, phase IIb efficacy and safety study on cystic fibrosis.

    Science.gov (United States)

    Dorkin, Henry L; Staab, Doris; Operschall, Elisabeth; Alder, Jeff; Criollo, Margarita

    2015-01-01

    Treatment of infective bronchitis involving Pseudomonas aeruginosa is a cornerstone of care in patients with cystic fibrosis (CF). This phase IIb, randomised, double-blind, placebo-controlled study assessed the efficacy and safety of ciprofloxacin dry powder for inhalation (DPI) in this population. Patients with CF, ≥12 years of age (N=286), were randomised to ciprofloxacin DPI (32.5 mg (n=93) or 48.75 mg (n=93)), or corresponding placebo (32.5 mg, n=65; 48.75 mg, n=35) twice daily for 28 days. The primary objective was the change in forced expiratory volume in 1 s (FEV1) from baseline (day 0) to end of treatment (day 29) in the intent-to-treat population for ciprofloxacin DPI compared with the corresponding placebo group. The primary effectiveness objective was not met; there were no significant differences in change in FEV1 between ciprofloxacin DPI and the corresponding placebo group for either dose (p=0.154). However, in pooled analyses, FEV1 decline from baseline to treatment end was significantly lower with ciprofloxacin DPI than with placebo (pooled data; p=0.02). Ciprofloxacin DPI showed positive effects on sputum bacterial load and quality of life, but these effects were not maintained at the 4-week follow-up. Ciprofloxacin DPI was well tolerated and there were no significant differences in type/incidence of treatment-emergent adverse events by treatment group (p=0.115). Further investigations are needed to determine the full scope of the beneficial effects of ciprofloxacin DPI for patients with CF. Clinicaltrials.gov NCT00645788; EudraCT 2008-008314-40.

  16. Effect of Including Extruded, Rolled or Ground Corn in Dairy Cow Diets Based on Direct Cut Grass Silage Efecto de la Inclusión de Maíz Extruido, Rolado o Molido en Dietas de Vacas Lecheras Basadas en Ensilaje de Pradera de Corte Directo

    Directory of Open Access Journals (Sweden)

    Christian Alvarado G

    2009-09-01

    Full Text Available A study was conducted to determine the effect of corn (Zea mays L. grain processing on intake, digestibility of nutrients and milk production and composition. The effect of extrusion on nutrient digestibility was evaluated in trial 1, using ground corn as a control. In trial 2, the effect of extrusion on intake was evaluated, comparing extruded corn of two densities (357 and 308 g L-1 with rolled corn (507 g L-1 as a control. In trial 3, the effects of extrusion on milk production, digestibility and intake were evaluated; using steam rolled corn and ground corn as controls. No effects on dry matter and metabolizable energy intakes due to differences in the extruded corn grains were observed. Digestibility of dry matter, organic matter, crude protein, gross energy and neutral detergent fiber did not differ among treatments, although a greater digestibility of non-fibrous carbohydrates was observed. Higher milk production was obtained in treatments including extruded and steam rolled corn (21.4 and 21.6 L d-1, compared to ground corn (20.5 L d-1 but differences disappeared when standardizing for fat content. Milk composition was not affected by treatments. Daily protein production was greater (P Se estudiaron los efectos del procesamiento del grano de maíz (Zea mays L. en el consumo y digestibilidad de la dieta, y en la composición y producción láctea. En el ensayo 1, se evaluó el efecto de la extrusión en la digestibilidad de la dieta utilizando maíz molido como control. En el ensayo 2, se evaluó el efecto de la extrusión en el consumo comparando maíz extruido de dos densidades (357 y 308 g L-1 usando maíz rolado (507 gL-1 como control. En el ensayo 3, se evaluó el efecto de la extrusión sobre la producción de leche, digestibilidad y consumo, empleando maíz rolado y maíz molido como controles. No se observaron diferencias en consumo de materia seca (MS ni de energía metabolizable atribuibles a diferencias de densidad del ma

  17. Evaluación de Beauveria bassiana para el combate de insectos plaga en maíz almacenado

    Directory of Open Access Journals (Sweden)

    Juan Diego Molina

    2000-01-01

    Full Text Available El objetivo de este estudio fue evaluar la patogenicidad de aislamientos de Beauveria bassiana, para controlar los insectos plaga Prostephanus truncatus y Stophilus zeamais, en mazorcas de maíz almacenado. Se evaluó también la patogenicidad del hongo sobre Teritriosoma nigrescens, depredador natural de P. truncatus. Se mezclaron conidios secos del hongo con kaolinita y se aplicaron a trojas de maíz de 450 mazorcas acomodadas en capas de 50. Se montaron dos ensayos, en el primero se evaluaron aplicaciones del hongo al momento de almacenar el maíz, y en el segundo se evaluaron aplicaciones del hongo realizadas después de almacenar el maíz. La mortalidad de P. truncatus fue cuatro veces mayor en el ensayo donde se aplicó el hongo en forma preventiva. La mortalidad de S. zeamais fue el doble en el tratamiento donde se aplicó el hongo al momento de inocular con P. truncatus. Los niveles de mortalidad por B. bassiana fueron mayores en P. truncatus que en S. zeamais, pero S. zeamais, pero este último mostró un 20% más de infección que el primero

  18. Nordic Walking improves daily physical activities in COPD: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Breyer Marie-Kathrin

    2010-08-01

    Full Text Available Abstract Background In patients with COPD progressive dyspnoea leads to a sedentary lifestyle. To date, no studies exist investigating the effects of Nordic Walking in patients with COPD. Therefore, the aim was to determine the feasibility of Nordic Walking in COPD patients at different disease stages. Furthermore we aimed to determine the short- and long-term effects of Nordic Walking on COPD patients' daily physical activity pattern as well as on patients exercise capacity. Methods Sixty COPD patients were randomised to either Nordic Walking or to a control group. Patients of the Nordic Walking group (n = 30; age: 62 ± 9 years; FEV1: 48 ± 19% predicted underwent a three-month outdoor Nordic Walking exercise program consisting of one hour walking at 75% of their initial maximum heart rate three times per week, whereas controls had no exercise intervention. Primary endpoint: daily physical activities (measured by a validated tri-axial accelerometer; secondary endpoint: functional exercise capacity (measured by the six-minute walking distance; 6MWD. Assessment time points in both groups: baseline, after three, six and nine months. Results After three month training period, in the Nordic Walking group time spent walking and standing as well as intensity of walking increased (Δ walking time: +14.9 ± 1.9 min/day; Δ standing time: +129 ± 26 min/day; Δ movement intensity: +0.40 ± 0.14 m/s2 while time spent sitting decreased (Δ sitting time: -128 ± 15 min/day compared to baseline (all: p Conclusions Nordic Walking is a feasible, simple and effective physical training modality in COPD. In addition, Nordic Walking has proven to positively impact the daily physical activity pattern of COPD patients under short- and long-term observation. Clinical trial registration Nordic Walking improves daily physical activities in COPD: a randomised controlled trial - ISRCTN31525632

  19. Maíz transgénico: ¿Beneficio para quién?

    Directory of Open Access Journals (Sweden)

    Bethel Marina Luna Mena

    2015-01-01

    Full Text Available En la introducción se comentan algunas de las consecuencias ecológicas, agronómicas, socioeconómicas y culturales de la liberación comercial de maíz transgénico en México. Posteriormente, se describe la situación actual del proceso de concentración y privatización en la producción y comercio de semillas a nivel mundial y de manera particular en México. Luego, se mencionan las oportunidades y alternativas que existen ante la situación descrita previamente. Así, se indican los aspectos relacionados con las patentes biotecnológicas dentro del contexto internacional y los Derechos de Obtentor, seguido del análisis de las propuestas de reformas a la Ley Federal de Variedades Vegetales del país. El documento finaliza con una discusión general y con las conclusiones.

  20. Patient controlled analgesia with remifentanil versus epidural analgesia in labour : randomised multicentre equivalence trial

    NARCIS (Netherlands)

    Freeman, Liv M; Bloemenkamp, Kitty W; Franssen, Maureen T; Papatsonis, Dimitri N; Hajenius, Petra J; Hollmann, Markus W; Woiski, Mallory D; Porath, Martina; van den Berg, Hans J; van Beek, Erik; Borchert, Odette W H M; Schuitemaker, Nico; Sikkema, J Marko; Kuipers, A H M; Logtenberg, Sabine L M; van der Salm, Paulien C M; Oude Rengerink, Katrien; Lopriore, Enrico; van den Akker-van Marle, M Elske; le Cessie, Saskia; van Lith, Jan M; Struys, Michel M; Mol, Ben Willem J; Dahan, Albert; Middeldorp, Johanna M; Oude Rengerink, K

    2015-01-01

    OBJECTIVE: To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. DESIGN: Multicentre randomised controlled equivalence trial. SETTING: 15 hospitals in the Netherlands. PARTICIPANTS: Women with an

  1. Patient controlled analgesia with remifentanil versus epidural analgesia in labour : randomised multicentre equivalence trial

    NARCIS (Netherlands)

    Freeman, Liv M.; Bloemenkamp, Kitty W.; Franssen, Maureen T.; Papatsonis, Dimitri N.; Hajenius, Petra J.; Hollmann, Markus W.; Woiski, Mallory D.; Porath, Martina; van den Berg, Hans J.; van Beek, Erik; Borchert, Odette W. H. M.; Schuitemaker, Nico; Sikkema, J. Marko; Kuipers, A. H. M.; Logtenberg, Sabine L. M.; van der Salm, Paulien C. M.; Rengerink, Katrien Oude; Lopriore, Enrico; van den Akker-van Marle, M. Elske; le Cessie, Saskia; van Lith, Jan M.; Struys, Michel M.; Mol, Ben Willem J.; Dahan, Albert; Middeldorp, Johanna M.

    2015-01-01

    Objective To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. Design Multicentre randomised controlled equivalence trial. Setting 15 hospitals in the Netherlands. Participants Women with an

  2. Patient controlled analgesia with remifentanil versus epidural analgesia in labour: randomised multicentre equivalence trial

    NARCIS (Netherlands)

    Freeman, L.M.; Bloemenkamp, K.W.; Franssen, M.T.; Papatsonis, D.N.; Hajenius, P.J.; Hollmann, M.W.; Woiski, M.D.; Porath, M.; Berg, H.J. van den; Beek, E. van; Borchert, O.W.; Schuitemaker, N.; Sikkema, J.M.; Kuipers, A.H.; Logtenberg, S.L.; Salm, P.C. van der; Oude Rengerink, K.; Lopriore, E.; Akker-van Marle, M.E. van den; Cessie, S. le; Lith, J.M. van; Struys, M.M.; Mol, B.W.; Dahan, A; Middeldorp, J.M.

    2015-01-01

    OBJECTIVE: To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. DESIGN: Multicentre randomised controlled equivalence trial. SETTING: 15 hospitals in the Netherlands. PARTICIPANTS: Women with an

  3. Mead acid (20:3n-9) and n-3 polyunsaturated fatty acids are not associated with risk of posterior longitudinal ligament ossification: results of a case-control study.

    Science.gov (United States)

    Hamazaki, Kei; Kawaguchi, Yoshiharu; Nakano, Masato; Yasuda, Taketoshi; Seki, Shoji; Hori, Takeshi; Hamazaki, Tomohito; Kimura, Tomoatsu

    2015-05-01

    Ossification of the posterior longitudinal ligament (OPLL) involves the replacement of ligamentous tissue with ectopic bone. Although genetics and heritability appear to be involved in the development of OPLL, its pathogenesis remains to be elucidated. Given previous findings that 5,8,11-eicosatrienoic acid [20:3n-9, Mead acid (MA)] has depressive effects on osteoblastic activity and anti-angiogenic effects, and that n-3 polyunsaturated fatty acids (PUFAs) have a preventive effect on heterotopic ossification, we hypothesized that both fatty acids would be involved in OPLL development. To examine the biological significance of these and other fatty acids in OPLL, we conducted this case-control study involving 106 patients with cervical OPLL and 109 age matched controls. Fatty acid composition was determined from plasma samples by gas chromatography. Associations between fatty acid levels and incident OPLL were evaluated by logistic regression. Contrary to our expectations, we found no significant differences between patients and controls in the levels of MA or n-3 PUFAs (e.g., eicosapentaenoic acid and docosahexaenoic acid). Logistic regression analysis did not reveal any associations with OPLL risk for MA or n-3 PUFAs. In conclusion, no potential role was found for MA or n-3 PUFAs in ectopic bone formation in the spinal canal. Copyright © 2015 Elsevier Ltd. All rights reserved.

  4. Labour pain with remifentanil patient-controlled analgesia versus epidural analgesia : a randomised equivalence trial

    NARCIS (Netherlands)

    Logtenberg, Slm; Oude Rengerink, K; Verhoeven, C J; Freeman, L M; van den Akker, Esa; Godfried, M B; van Beek, E; Borchert, Owhm; Schuitemaker, N; van Woerkens, Ecsm; Hostijn, I; Middeldorp, J M; van der Post, J A; Mol, B W

    OBJECTIVE: To distinguish satisfaction with pain relief using remifentanil patient-controlled analgesia (RPCA) compared with epidural analgesia (EA) in low-risk labouring women. DESIGN: Randomised controlled equivalence trial. SETTING: Eighteen midwifery practices and six hospitals in the

  5. Consideraciones socioeconómicas y culturales en la controvertida introducción del maíz transgénico: el caso de Tlaxcala

    OpenAIRE

    Lazos Chavero, Elena

    2014-01-01

    Los agricultores cultivan maíces nativos e híbridos en tierras ejidales, privadas o rentadas para lograr el autoconsumo y surtir al mercado regional. Los híbridos están impulsados por Modernización Sustentable de la Agricultura Tradicional, el Centro Internacional de Mejoramiento de Maíz y Trigo, la Secretaría de Fomento Agropecuario y por la industria de la tortilla. Las plagas y las malezas no afectan la producción; herbicidas e insecticidas representan los menores costos. Los maíces transg...

  6. Brexanolone (SAGE-547 injection) in post-partum depression: a randomised controlled trial.

    Science.gov (United States)

    Kanes, Stephen; Colquhoun, Helen; Gunduz-Bruce, Handan; Raines, Shane; Arnold, Ryan; Schacterle, Amy; Doherty, James; Epperson, C Neill; Deligiannidis, Kristina M; Riesenberg, Robert; Hoffmann, Ethan; Rubinow, David; Jonas, Jeffrey; Paul, Steven; Meltzer-Brody, Samantha

    2017-07-29

    Post-partum depression is a serious mood disorder in women that might be triggered by peripartum fluctuations in reproductive hormones. This phase 2 study investigated brexanolone (USAN; formerly SAGE-547 injection), an intravenous formulation of allopregnanolone, a positive allosteric modulator of γ-aminobutyric acid (GABA A ) receptors, for the treatment of post-partum depression. For this double-blind, randomised, placebo-controlled trial, we enrolled self-referred or physician-referred female inpatients (≤6 months post partum) with severe post-partum depression (Hamilton Rating Scale for Depression [HAM-D] total score ≥26) in four hospitals in the USA. Eligible women were randomly assigned (1:1), via a computer-generated randomisation program, to receive either a single, continuous intravenous dose of brexanolone or placebo for 60 h. Patients and investigators were masked to treatment assignments. The primary efficacy endpoint was the change from baseline in the 17-item HAM-D total score at 60 h, assessed in all randomised patients who started infusion of study drug or placebo and who had a completed baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Patients were followed up until day 30. This trial is registered with ClinicalTrials.gov, number NCT02614547. This trial was done between Dec 15, 2015 (first enrolment), and May 19, 2016 (final visit of the last enrolled patient). 21 women were randomly assigned to the brexanolone (n=10) and placebo (n=11) groups. At 60 h, mean reduction in HAM-D total score from baseline was 21·0 points (SE 2·9) in the brexanolone group compared with 8·8 points (SE 2·8) in the placebo group (difference -12·2, 95% CI -20·77 to -3·67; p=0·0075; effect size 1·2). No deaths, serious adverse events, or discontinuations because of adverse events were reported in either group. Four of ten patients in the brexanolone group had adverse events compared with eight of 11 in the placebo group. The most

  7. Patient controlled analgesia with remifentanil versus epidural analgesia in labour: randomised multicentre equivalence trial

    NARCIS (Netherlands)

    Freeman, Liv M.; Bloemenkamp, Kitty W.; Franssen, Maureen T.; Papatsonis, Dimitri N.; Hajenius, Petra J.; Hollmann, Markus W.; Woiski, Mallory D.; Porath, Martina; van den Berg, Hans J.; van Beek, Erik; Borchert, Odette W. H. M.; Schuitemaker, Nico; Sikkema, J. Marko; Kuipers, A. H. M.; Logtenberg, Sabine L. M.; van der Salm, Paulien C. M.; Oude Rengerink, Katrien; Lopriore, Enrico; van den Akker-van Marle, M. Elske; le Cessie, Saskia; van Lith, Jan M.; Struys, Michel M.; Mol, Ben Willem J.; Dahan, Albert; Middeldorp, Johanna M.

    2015-01-01

    To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. Multicentre randomised controlled equivalence trial. 15 hospitals in the Netherlands. Women with an intermediate to high obstetric risk with an

  8. A modification of the Regional Nutrient Management model (ReNuMa) to identify long-term changes in riverine nitrogen sources

    Science.gov (United States)

    Hu, Minpeng; Liu, Yanmei; Wang, Jiahui; Dahlgren, Randy A.; Chen, Dingjiang

    2018-06-01

    Source apportionment is critical for guiding development of efficient watershed nitrogen (N) pollution control measures. The ReNuMa (Regional Nutrient Management) model, a semi-empirical, semi-process-oriented model with modest data requirements, has been widely used for riverine N source apportionment. However, the ReNuMa model contains limitations for addressing long-term N dynamics by ignoring temporal changes in atmospheric N deposition rates and N-leaching lag effects. This work modified the ReNuMa model by revising the source code to allow yearly changes in atmospheric N deposition and incorporation of N-leaching lag effects into N transport processes. The appropriate N-leaching lag time was determined from cross-correlation analysis between annual watershed individual N source inputs and riverine N export. Accuracy of the modified ReNuMa model was demonstrated through analysis of a 31-year water quality record (1980-2010) from the Yongan watershed in eastern China. The revisions considerably improved the accuracy (Nash-Sutcliff coefficient increased by ∼0.2) of the modified ReNuMa model for predicting riverine N loads. The modified model explicitly identified annual and seasonal changes in contributions of various N sources (i.e., point vs. nonpoint source, surface runoff vs. groundwater) to riverine N loads as well as the fate of watershed anthropogenic N inputs. Model results were consistent with previously modeled or observed lag time length as well as changes in riverine chloride and nitrate concentrations during the low-flow regime and available N levels in agricultural soils of this watershed. The modified ReNuMa model is applicable for addressing long-term changes in riverine N sources, providing decision-makers with critical information for guiding watershed N pollution control strategies.

  9. Timing of insertion of levonorgestrel-releasing intrauterine system : a randomised controlled trial

    NARCIS (Netherlands)

    van der Heijden, Pahh; Geomini, Pmaj; Herman, M C; Veersema, S; Bongers, M Y

    OBJECTIVE: The objective was to assess whether patient-perceived pain during the insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) depends on the timing during the menstrual cycle. DESIGN: A stratified two-armed non-inferiority randomised controlled trial. SETTING: Large

  10. FİLMLERLE İLETİŞİM VE YABANCILAŞMA

    OpenAIRE

    ÖZTÜRK, Serdar

    2018-01-01

    Yabancılaşma konusu genellikle iktisadi, sosyolojik ve psikoloji boyutlarıyla tartışılmıştır. Oysa bir anlam paylaşımı olarak iletişim, yabancılaşmayla doğrudan ilişkilidir. Buna karşın iletişim ile yabancılaşma ilişkisini, analize filmleri de katarak inceleyen çok az çalışma bulunmaktadır. Bu çalışma, yabancılaşma kavramını tartışarak, yabancılaşmanın iletişim ile ilişkisini incelemektedir. Buna göre insanın kendi ürettiği sembollerine, medyanın üretim bölgesinde üretilen sembollere yabancıl...

  11. Synthesis, Biodistribution and In vitro Evaluation of Brain Permeable High Affinity Type 2 Cannabinoid Receptor Agonists [11C]MA2 and [18F]MA3.

    Science.gov (United States)

    Ahamed, Muneer; van Veghel, Daisy; Ullmer, Christoph; Van Laere, Koen; Verbruggen, Alfons; Bormans, Guy M

    2016-01-01

    The type 2 cannabinoid receptor (CB2) is a member of the endocannabinoid system and is known for its important role in (neuro)inflammation. A PET-imaging agent that allows in vivo visualization of CB2 expression may thus allow quantification of neuroinflammation. In this paper, we report the synthesis, radiosynthesis, biodistribution and in vitro evaluation of a carbon-11 ([ 11 C]MA2) and a fluorine-18 ([ 18 F]MA3) labeled analog of a highly potent N -arylamide oxadiazole CB2 agonist (EC 50 = 0.015 nM). MA2 and MA3 behaved as potent CB2 agonist (EC 50 : 3 nM and 0.1 nM, respectively) and their in vitro binding affinity for h CB2 was found to be 87 nM and 0.8 nM, respectively. Also MA3 (substituted with a fluoro ethyl group) was found to have higher binding affinity and EC 50 values when compared to the originally reported trifluoromethyl analog 12 . [ 11 C]MA2 and [ 18 F]MA3 were successfully synthesized with good radiochemical yield, high radiochemical purity and high specific activity. In mice, both tracers were efficiently cleared from blood and all major organs by the hepatobiliary pathway and importantly these compounds showed high brain uptake. In conclusion, [ 11 C]MA2 and [ 18 F]MA3 are shown to be high potent CB2 agonists with good brain uptake, these favorable characteristics makes them potential PET probes for in vivo imaging of brain CB2 receptors. However, in view of its higher affinity and selectivity, further detailed evaluation of MA3 as a PET tracer for CB2 is warranted.

  12. Personalised Hip Therapy: development of a non-operative protocol to treat femoroacetabular impingement syndrome in the FASHIoN randomised controlled trial.

    Science.gov (United States)

    Wall, Peter Dh; Dickenson, Edward J; Robinson, David; Hughes, Ivor; Realpe, Alba; Hobson, Rachel; Griffin, Damian R; Foster, Nadine E

    2016-10-01

    Femoroacetabular impingement (FAI) syndrome is increasingly recognised as a cause of hip pain. As part of the design of a randomised controlled trial (RCT) of arthroscopic surgery for FAI syndrome, we developed a protocol for non-operative care and evaluated its feasibility. In phase one, we developed a protocol for non-operative care for FAI in the UK National Health Service (NHS), through a process of systematic review and consensus gathering. In phase two, the protocol was tested in an internal pilot RCT for protocol adherence and adverse events. The final protocol, called Personalised Hip Therapy (PHT), consists of four core components led by physiotherapists: detailed patient assessment, education and advice, help with pain relief and an exercise-based programme that is individualised, supervised and progressed over time. PHT is delivered over 12-26 weeks in 6-10 physiotherapist-patient contacts, supplemented by a home exercise programme. In the pilot RCT, 42 patients were recruited and 21 randomised to PHT. Review of treatment case report forms, completed by physiotherapists, showed that 13 patients (62%) received treatment that had closely followed the PHT protocol. 13 patients reported some muscle soreness at 6 weeks, but there were no serious adverse events. PHT provides a structure for the non-operative care of FAI and offers guidance to clinicians and researchers in an evolving area with limited evidence. PHT was deliverable within the National Health Service, is safe, and now forms the comparator to arthroscopic surgery in the UK FASHIoN trial (ISRCTN64081839). ISRCTN 09754699. 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/

  13. Randomised controlled trial of Alexander technique lessons, exercise, and massage (ATEAM) for chronic and recurrent back pain.

    Science.gov (United States)

    Little, Paul; Lewith, George; Webley, Fran; Evans, Maggie; Beattie, Angela; Middleton, Karen; Barnett, Jane; Ballard, Kathleen; Oxford, Frances; Smith, Peter; Yardley, Lucy; Hollinghurst, Sandra; Sharp, Debbie

    2008-08-19

    To determine the effectiveness of lessons in the Alexander technique, massage therapy, and advice from a doctor to take exercise (exercise prescription) along with nurse delivered behavioural counselling for patients with chronic or recurrent back pain. Factorial randomised trial. 64 general practices in England. 579 patients with chronic or recurrent low back pain; 144 were randomised to normal care, 147 to massage, 144 to six Alexander technique lessons, and 144 to 24 Alexander technique lessons; half of each of these groups were randomised to exercise prescription. Normal care (control), six sessions of massage, six or 24 lessons on the Alexander technique, and prescription for exercise from a doctor with nurse delivered behavioural counselling. Roland Morris disability score (number of activities impaired by pain) and number of days in pain. Exercise and lessons in the Alexander technique, but not massage, remained effective at one year (compared with control Roland disability score 8.1: massage -0.58, 95% confidence interval -1.94 to 0.77, six lessons -1.40, -2.77 to -0.03, 24 lessons -3.4, -4.76 to -2.03, and exercise -1.29, -2.25 to -0.34). Exercise after six lessons achieved 72% of the effect of 24 lessons alone (Roland disability score -2.98 and -4.14, respectively). Number of days with back pain in the past four weeks was lower after lessons (compared with control median 21 days: 24 lessons -18, six lessons -10, massage -7) and quality of life improved significantly. No significant harms were reported. One to one lessons in the Alexander technique from registered teachers have long term benefits for patients with chronic back pain. Six lessons followed by exercise prescription were nearly as effective as 24 lessons. National Research Register N0028108728.

  14. Internet cognitive behavioural treatment for obsessive compulsive disorder : A randomised controlled trial

    NARCIS (Netherlands)

    Mahoney, Alison E J; Mackenzie, Anna; Williams, Alishia D; Smith, Jessica; Andrews, Gavin

    2014-01-01

    Internet-based cognitive behaviour therapy (iCBT) is becoming increasing accepted as an efficacious and effective treatment for the anxiety and depressive disorders. However few studies have examined the efficacy of iCBT for obsessive compulsive disorder (OCD). This randomised controlled trial

  15. Randomised controlled trial of site specific advice on school travel patterns.

    Science.gov (United States)

    Rowland, D; DiGuiseppi, C; Gross, M; Afolabi, E; Roberts, I

    2003-01-01

    To evaluate the effect of site specific advice from a school travel coordinator on school travel patterns. Cluster randomised controlled trial of children attending 21 primary schools in the London boroughs of Camden and Islington. A post-intervention survey measured the proportion of children walking, cycling, or using public transport for travel to school, and the proportion of parents/carers very or quite worried about traffic and abduction. The proportion of schools that developed and implemented travel plans was assessed. One year post-intervention, nine of 11 intervention schools and none of 10 control schools had travel plans. Proportions of children walking, cycling, or using public transport on the school journey were similar in intervention and control schools. The proportion of parents who were very or quite worried about traffic danger was similar in the intervention (85%) and control groups (87%). However, after adjusting for baseline and other potential confounding factors we could not exclude the possibility of a modest reduction in parental concern about traffic danger as a result of the intervention. Having a school travel coordinator increased the production of school travel plans but there was no evidence that this changed travel patterns or reduced parental fears. Given the uncertainty about effectiveness, the policy of providing school travel coordinators should only be implemented within the context of a randomised controlled trial.

  16. Disc extrusions and bulges in nonspecific low back pain and sciatica: Exploratory randomised controlled trial comparing yoga therapy and normal medical treatment.

    Science.gov (United States)

    Monro, Robin; Bhardwaj, Abhishek Kumar; Gupta, Ram Kumar; Telles, Shirley; Allen, Beth; Little, Paul

    2015-01-01

    Previous trials of yoga therapy for nonspecific low back pain (nsLBP) (without sciatica) showed beneficial effects. To test effects of yoga therapy on pain and disability associated with lumbar disc extrusions and bulges. Parallel-group, randomised, controlled trial. Sixty-one adults from rural population, aged 20-45, with nsLBP or sciatica, and disc extrusions or bulges. Randomised to yoga (n=30) and control (n=31). Yoga: 3-month yoga course of group classes and home practice, designed to ensure safety for disc extrusions. normal medical care. OUTCOME MEASURES (3-4 months) Primary: Roland Morris Disability Questionnaire (RMDQ); worst pain in past two weeks. Secondary: Aberdeen Low Back Pain Scale; straight leg raise test; structural changes. Disc projections per case ranged from one bulge or one extrusion to three bulges plus two extrusions. Sixty-two percent had sciatica. Intention-to-treat analysis of the RMDQ data, adjusted for age, sex and baseline RMDQ scores, gave a Yoga Group score 3.29 points lower than Control Group (0.98, 5.61; p=0.006) at 3 months. No other significant differences in the endpoints occurred. No adverse effects of yoga were reported. Yoga therapy can be safe and beneficial for patients with nsLBP or sciatica, accompanied by disc extrusions and bulges.

  17. Study protocol: a randomised controlled trial of a theory-based online intervention to improve sun safety among Australian adults

    International Nuclear Information System (INIS)

    Cleary, Cathy M; White, Katherine M; Young, Ross McD; Hawkes, Anna L; Leske, Stuart; Starfelt, Louise C; Wihardjo, Kylie

    2014-01-01

    The effects of exposure to ultraviolet radiation are a significant concern in Australia which has one of the highest incidences of skin cancer in the world. Despite most skin cancers being preventable by encouraging consistent adoption of sun-protective behaviours, incidence rates are not decreasing. There is a dearth of research examining the factors involved in engaging in sun-protective behaviours. Further, online multi-behavioural theory-based interventions have yet to be explored fully as a medium for improving sun-protective behaviour in adults. This paper presents the study protocol of a randomised controlled trial of an online intervention based on the Theory of Planned Behaviour (TPB) that aims to improve sun safety among Australian adults. Approximately 420 adults aged 18 and over and predominantly from Queensland, Australia, will be recruited and randomised to the intervention (n = 200), information only (n = 200) or the control group (n = 20). The intervention focuses on encouraging supportive attitudes and beliefs toward sun-protective behaviour, fostering perceptions of normative support for sun protection, and increasing perceptions of control/self-efficacy over sun protection. The intervention will be delivered online over a single session. Data will be collected immediately prior to the intervention (Time 1), immediately following the intervention (Time 1b), and one week (Time 2) and one month (Time 3) post-intervention. Primary outcomes are intentions to sun protect and sun-protective behaviour. Secondary outcomes are the participants’ attitudes toward sun protection, perceptions of normative support for sun protection (i.e. subjective norms, group norms, personal norms and image norms) and perceptions of control/self-efficacy toward sun protection. The study will contribute to an understanding of the effectiveness of a TPB-based online intervention to improve Australian adults’ sun-protective behaviour. Australian and New Zealand Trials

  18. Perceived Comfort and Blinding Efficacy in Randomised Sham-Controlled Transcranial Direct Current Stimulation (tDCS Trials at 2 mA in Young and Older Healthy Adults.

    Directory of Open Access Journals (Sweden)

    Denise Wallace

    Full Text Available tDCS studies typically find that: lowest levels of comfort occur at stimulation-onset; young adult participants experience less comfort than older participants; and participants' blinding seems effective at low current strengths. At 2 mA conflicting results have been reported, questioning the effectiveness of blinding in sham-controlled paradigms using higher current strengths. Investigator blinding is rarely reported.Using a protocol with 30 min of 2 mA stimulation we sought to: (a investigate the level of perceived comfort in young and older adults, ranging in age from 19 to 29 years and 63 to 76 years, respectively; (b test investigator and participant blinding; (c assess comfort over a longer stimulation duration; (d add to the literature on protocols using 2 mA current strength.A two-session experiment was conducted where sham and active stimulation were administered to the frontal cortex at the F8/FP1 sites in a within-subjects manner. Levels of perceived comfort were measured, using a visual analogue scale, at the start and end of stimulation in young and older adults. Post-stimulation, participants and investigators judged whether or not active stimulation was used.Comfort scores were lower at stimulation onset in both age groups. Older adults reported: (i more comfort than young participants overall; (ii comparable levels of comfort in sham and active stimulation; (iii significantly more comfort than the young participants during active stimulation. Stimulation mode was correctly identified above chance in the second of the two sessions; 65% of all participants correctly identified the stimulation mode, resulting in a statistical trend. Similarly, the experimenter correctly identified stimulation mode significantly above chance, with 62% of all investigator judgements correct across 120 judgements.Using 2 mA current strength over 30 minutes, tDCS stimulation comfort is lower at stimulation onset in young and older adults and, overall

  19. Synthesis, biodistribution and in vitro evaluation of brain permeable high affinity type 2 cannabinoid receptor agonists [11C]MA2 and [18F]MA3

    Directory of Open Access Journals (Sweden)

    Muneer Ahamed

    2016-09-01

    Full Text Available Abstract The type 2 cannabinoid receptor (CB2 is a member of the endocannabinoid system and is known for its important role in (neuroinflammation. A PET-imaging agent that allows in vivo visualization of CB2 expression may thus allow quantification of neuroinflammation. In this paper, we report the synthesis, radiosynthesis, biodistribution and in vitro evaluation of a carbon-11 ([11C]MA2 and a fluorine-18 ([18F]MA3 labeled analogue of a highly potent N-arylamide oxadiazole CB2 agonist (EC50 = 0.015 nM. MA2 and MA3 behaved as potent CB2 agonist (EC50: 3 nM and 0.1 nM, respectively and their in vitro binding affinity for hCB2 was found to be 87 nM and 0.8 nM, respectively. Also MA3 (substituted with a fluoro ethyl group was found to have higher binding affinity and EC50 values when compared to the originally reported trifluoromethyl analogue 12. [11C]MA2 and [18F]MA3 were successfully synthesized with good radiochemical yield, high radiochemical purity and high specific activity. In mice, both tracers were efficiently cleared from blood and all major organs by the hepatobiliary pathway and importantly these compounds showed high brain uptake. In conclusion, [11C]MA2 and [18F]MA3 are shown to be high potent CB2 agonists with good brain uptake, these favorable characteristics makes them potential PET probes for in vivo imaging of brain CB2 receptors. However in view of its higher affinity and selectivity, further detailed evaluation of MA3 as a PET tracer for CB2 is warranted.

  20. Cervical pessary in pregnant women with a short cervix (PECEP): an open-label randomised controlled trial.

    Science.gov (United States)

    Goya, Maria; Pratcorona, Laia; Merced, Carme; Rodó, Carlota; Valle, Leonor; Romero, Azahar; Juan, Miquel; Rodríguez, Alberto; Muñoz, Begoña; Santacruz, Belén; Bello-Muñoz, Juan Carlos; Llurba, Elisa; Higueras, Teresa; Cabero, Luis; Carreras, Elena

    2012-05-12

    Most previous studies of the use of cervical pessaries were either retrospective or case controlled and their results showed that this intervention might be a preventive strategy for women at risk of preterm birth; no randomised controlled trials have been undertaken. We therefore undertook a randomised, controlled trial to investigate whether the insertion of a cervical pessary in women with a short cervix identified by use of routine transvaginal scanning at 20-23 weeks of gestation reduces the rate of early preterm delivery. The Pesario Cervical para Evitar Prematuridad (PECEP) trial was undertaken in five hospitals in Spain. Pregnant women (aged 18-43 years) with a cervical length of 25 mm or less were randomly assigned according to a computer-generated allocation sequence by use of central telephone in a 1:1 ratio to the cervical pessary or expectant management (without a cervical pessary) group. Because of the nature of the intervention, this study was not masked. The primary outcome was spontaneous delivery before 34 weeks of gestation. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00706264. 385 pregnant women with a short cervix were assigned to the pessary (n=192) and expectant management groups (n=193), and 190 were analysed in each group. Spontaneous delivery before 34 weeks of gestation was significantly less frequent in the pessary group than in the expectant management group (12 [6%] vs 51 [27%], odds ratio 0·18, 95% CI 0·08-0·37; p<0·0001). No serious adverse effects associated with the use of a cervical pessary were reported. Cervical pessary use could prevent preterm birth in a population of appropriately selected at-risk women previously screened for cervical length assessment at the midtrimester scan. Instituto Carlos III. Copyright © 2012 Elsevier Ltd. All rights reserved.

  1. Procesamiento del grano de maíz sobre la cinética de degradación de la materia seca in vitro

    Directory of Open Access Journals (Sweden)

    Raul Velásquez V.

    2013-11-01

    Full Text Available Objetivo. Determinar el efecto del procesamiento del grano de maíz sobre la cinética de degradación y fermentación de la materia seca in vitro. Materiales y métodos. Se evaluaron cinco tratamientos, cada uno constó de una mezcla con dos especies, 70% pasto Kikuyo (Pennisetum clandestinum y 30% grano de maíz (Zea mays. El grano fue sometido a diferentes procesamientos: maíz grueso seco (MGS, maíz fino seco (MFS, maíz reconstituido (MGH, reconstituido y ensilado (MGE y ensilado con urea (MGEU. Se realizó la técnica de gas in vitro para medir parámetros de degradación y de producción de gas en diferentes horarios hasta las 48 h. Se utilizaron los modelos de Gompertz y Ørskov y McDonald para ajustar las curvas de producción de gas y degradación de MS y se evaluaron con PROC NLIN de SAS. Resultados. Los mayores volúmenes acumulados fueron obtenidos con los tratamientos MFS y MGEU con 552.5 ml y 524.03 ml, respectivamente y fueron diferentes al tratamiento MGS (p<0.05. El potencial de degradación (A+B en MGS mostró el menor valor, siendo diferente (p<0.05 a los tratamientos MFS, MGE y MGEU. Conclusiones. El tipo de procesamiento del grano de máiz molido fino, reconstituido, ensilado con y sin urea mejoraron significativamente los parámetros de fermentación y degradación de la MS. El uso de grano molido fino (2 mm puede ser reemplazado por grano grueso reconstituido y ensilado, el cual resulta más económico que la molienda fina.

  2. Maternal note-taking and infant care: a pilot randomised controlled trial.

    Science.gov (United States)

    Kistin, Caroline J; Barrero-Castillero, Alejandra; Lewis, Sheilajane; Hoch, Rachel; Philipp, Barbara L; Bauchner, Howard; Wang, C Jason

    2012-10-01

    A pilot randomised controlled trial was conducted with postpartum mothers to assess the feasibility and impact of note-taking during newborn teaching. Controls received standard teaching; the intervention group received pen and paper to take notes. Subjects were called 2 days post-discharge to assess infant sleep position, breastfeeding, car seat use, satisfaction and information recall. 126 mothers were randomised. There was a consistent trend that intervention subjects were more likely to report infant supine sleep position (88% vs 78%, relative risks (RR) 1.13; 95% CI 0.95 to 1.34), breastfeeding (96% vs 86%, RR 1.11; 95% CI 0.99 to 1.25) and correct car seat use (98% vs 87%, RR 1.12; 95% CI 1.00 to 1.25). Satisfaction and information recall did not differ. Among first-time mothers, intervention subjects were significantly more likely to report infant supine sleep position (95% vs 65%, RR 1.46; 95% CI 1.06 to 2.00). Maternal note-taking is feasible and potentially efficacious in promoting desirable infant care.

  3. Can a documentary increase help-seeking intentions in men? A randomised controlled trial.

    Science.gov (United States)

    King, Kylie Elizabeth; Schlichthorst, Marisa; Spittal, Matthew J; Phelps, Andrea; Pirkis, Jane

    2018-01-01

    We investigated whether a public health intervention-a three-part documentary called Man Up which explored the relationship between masculinity and mental health, well-being and suicidality-could increase men's intentions to seek help for personal and emotional problems. We recruited men aged 18 years or over who were not at risk of suicide to participate in a double-blind randomised controlled trial. Participants were randomly assigned (1:1) via computer randomisation to view Man Up (the intervention) or a control documentary. We hypothesised that 4 weeks after viewing Man Up participants would report higher levels of intention to seek help than those who viewed the control documentary. Our primary outcome was assessed using the General Help Seeking Questionnaire, and was analysed for all participants. The trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12616001169437, Universal Trial Number: U1111-1186-1459) and was funded by the Movember Foundation. Three hundred and fifty-four men were assessed for eligibility for the trial and randomised to view Man Up or the control documentary. Of these, 337 completed all stages (nine participants were lost to follow-up in the intervention group and eight in the control group). Linear regression analysis showed a significant increase in intentions to seek help in the intervention group, but not in the control group (coef.=2.06, 95% CI 0.48 to 3.63, P=0.01). Our trial demonstrates the potential for men's health outcomes to be positively impacted by novel, media-based public health interventions that focus on traditional masculinity. ACTRN12616001169437, Results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  4. Eficiencia agronómica, rendimiento y rentabilidad de genotipos de maíz en función del nitrógeno

    Directory of Open Access Journals (Sweden)

    Cid Aguilar Carpio

    2016-10-01

    Full Text Available En el cultivo de maíz, la fertilización nitrogenada es una alta inversión que posiblemente incrementa el rendimiento. Sin embargo, es imprescindible ser eficiente en el uso del agua y nitrógeno (N, para la producción. El nitrógeno mejora la composición de proteínas en el grano, pero de forma excesiva es perjudicial a la salud humana. El objetivo del presente estudio fue determinar el efecto del nitrógeno en genotipos de maíz sobre: a la ocurrencia de las fases fenológicas; b producción de materia seca y rendimiento; c eficiencia en el uso del agua y nitrógeno; d contenido de nitrógeno y proteína en el grano; y e rentabilidad en maíz. La siembra de los genotipos Michoacán-21, HS-2 y Promesa con 0, 80 y 160 kg N ha-1, se realizó en Montecillo, Estado de México en junio de 2011. Se registró, la ocurrencia de las fases fenológicas y madurez fisiológica del maíz, la materia seca (MS, rendimiento de grano (RG, contenido de nitrógeno y proteína en el grano, eficiencia en el uso de agua y nitrógeno (EUA y EAN y rentabilidad económica. Se observaron diferencias entre genotipos en la ocurrencia de las fases fenológicas. La respuesta al nitrógeno entre genotipos fue variable. El mayor MS y RG fue en el genotipo Promesa con 80 kg N ha-1 y 160 kg N ha-1 respectivamente. La EUA y EAN más alta, se obtuvo en Promesa con 80 kg N ha‑1. El contenido de nitrógeno y proteína más alto fue en el grano de maíz de HS-2 con 160 kg N ha-1. El mayor ingreso neto ($12 685.90 se logró con Promesa y 80 kg N ha-1.

  5. A randomised controlled trial evaluating family mediated exercise (FAME therapy following stroke

    Directory of Open Access Journals (Sweden)

    Stokes Emma

    2008-06-01

    Full Text Available Abstract Background Stroke is a leading cause of disability among adults worldwide. Evidence suggests that increased duration of exercise therapy following stroke has a positive impact on functional outcome following stroke. The main objective of this randomised controlled trial is to evaluate the impact of additional family assisted exercise therapy in people with acute stroke. Methods/Design A prospective multi-centre single blind randomised controlled trial will be conducted. Forty patients with acute stroke will be randomised into either an experimental or control group. The experimental group will receive routine therapy and additional lower limb exercise therapy in the form of family assisted exercises. The control group will receive routine therapy with no additional formal input from their family members. Participants will be assessed at baseline, post intervention and followed up at three months using a series of standardised outcome measures. A secondary aim of the project is to evaluate the impact of the family mediated exercise programme on the person with stroke and the individual(s assisting in the delivery of exercises using a qualitative methodology. The study has gained ethical approval from the Research Ethics Committees of each of the clinical sites involved in the study. Discussion This study will evaluate a structured programme of exercises that can be delivered to people with stroke by their 'family members/friends'. Given that the progressive increase in the population of older people is likely to lead to an increased prevalence of stroke in the future, it is important to reduce the burden of this illness on the individual, the family and society. Family mediated exercises can maximise the carry over outside formal physiotherapy sessions, giving patients the opportunity for informal practice. Trial Registration The protocol for this study is registered with the US NIH Clinical trials registry (NCT00666744

  6. Skeletal effects and functional outcome with olpadronate in children with osteogenesis imperfecta: a 2-year randomised placebo-controlled study

    NARCIS (Netherlands)

    Sakkers, Ralph; Kok, Dieke; Engelbert, Raoul; van Dongen, Alice; Jansen, Maarten; Pruijs, Hans; Verbout, Ab; Schweitzer, Dave; Uiterwaal, Cuno

    2004-01-01

    Non-randomised studies have suggested beneficial effects of bisphosphonates in osteogenesis imperfecta. We assessed the effects of oral olpadronate in children with this disorder in a randomised double-blind placebo-controlled trial. 34 children recruited from the Dutch national centre for

  7. A randomised controlled trial to assess the effectiveness of a nurse-led palliative care intervention for HIV positive patients on antiretroviral therapy: recruitment, refusal, randomisation and missing data.

    Science.gov (United States)

    Lowther, Keira; Higginson, Irene J; Simms, Victoria; Gikaara, Nancy; Ahmed, Aabid; Ali, Zipporah; Afuande, Gaudencia; Kariuki, Hellen; Sherr, Lorraine; Jenkins, Rachel; Selman, Lucy; Harding, Richard

    2014-09-03

    Despite the life threatening nature of an HIV diagnosis and the multidimensional problems experienced by this patient population during antiretroviral therapy, the effectiveness of a palliative care approach for HIV positive patients on ART is as yet unknown. A randomised controlled trial (RCT) was conducted in a sample of 120 HIV positive patients on ART in an urban clinic in Mombasa, Kenya. The intervention was a minimum of seven sessions of multidimensional, person-centred care, given by HIV nurses trained in the palliative care approach over a period of 5 months. Rates of recruitment and refusal, the effectiveness of the randomisation procedure, trial follow-up and attrition and extent of missing data are reported.120 patients (60 randomised to control arm, 60 randomised to intervention arm) were recruited over 5.5 months, with a refusal rate of 55.7%. During the study period, three participants died from cancer, three withdrew (two moved away and one withdrew due to time constraints). All of these patients were in the intervention arm: details are reported. There were five additional missing monthly interviews in both the control and intervention study arm, bringing the total of missing data to 26 data points (4.3%). The quality and implications of these data are discussed extensively and openly, including the effect of full and ethical consent procedures, respondent burden, HIV stigma, accurate randomisation, patient safety and the impact of the intervention. Data on recruitment randomisation, attrition and missing data in clinical trials should be routinely reported, in conjunction with the now established practice of publishing study protocols to enhance research integrity, transparency and quality. Transparency is especially important in cross cultural settings, in which the sources of funding and trial design are often not based in the country of data collection. Findings reported can be used to inform future RCTs in this area. Clinicaltrials.gov NCT

  8. Medical prescription of heroin to treatment resistant heroin addicts: two randomised controlled trials

    NARCIS (Netherlands)

    van den Brink, Wim; Hendriks, Vincent M.; Blanken, Peter; Koeter, Maarten W. J.; van Zwieten, Barbara J.; van Ree, Jan M.

    2003-01-01

    OBJECTIVE: To determine whether supervised medical prescription of heroin can successfully treat addicts who do not sufficiently benefit from methadone maintenance treatment. DESIGN: Two open label randomised controlled trials. SETTING: Methadone maintenance programmes in six cities in the

  9. The efficacy of a group Cognitive Behavioural Therapy for war-affected young migrants living in Australia: A cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Chew Sia Ooi

    2016-10-01

    Full Text Available BackgroundPreventative and treatment programmes for people at risk of developing psychological problems after exposure to war trauma have mushroomed in the last decade. However, there is still much contention about evidence-based and culturally sensitive interventions for children. The aim of this study was to examine the efficacy of the Teaching Recovery Techniques in improving the emotional and behavioural outcomes of war-affected children resettled in Australia. Methods and findings A cluster randomised controlled trial with pretest, posttest, and 3-month follow-up design was employed. A total of 82 participants (aged 10 to 17 years were randomised by school into the 8-week intervention (n = 45 or the waiting list (WL control condition (n = 37. Study outcomes included symptoms of posttraumatic stress disorder, depression, internalising and externalising problems, as well as psychosocial functioning. A medium intervention effect was found for depression symptoms. Participants in the intervention condition experienced a greater symptom reduction than participants in the WL control condition, F(1,155 = 5.20, p = .024, partial ƞ2 = 0.07. This improvement was maintained at the 3-month follow-up, F(2,122 = 7.24, p = .001, partial ƞ2 = 0.20. ConclusionsThese findings suggest the potential benefit of the school and group-based intervention on depression symptoms but not on other outcomes, when compared to a waiting list control group.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12611000948998

  10. Randomised controlled trials and changing public health practice

    Directory of Open Access Journals (Sweden)

    Anne Cockcroft

    2017-05-01

    Full Text Available Abstract One reason for doing randomised controlled trials (RCTs is that experiments can be convincing. Early epidemiological experimenters, such as Jenner and the smallpox vaccine and Snow and his famous Broad Street pump handle, already knew the answer they were demonstrating; they used the experiments as knowledge translation devices to convince others. More sophisticated modern experiments include cluster randomised controlled trials (CRCTs for experiments in the public health setting. The knowledge translation value remains: RCTs and CRCTs can potentially stimulate changes of practice among stakeholders. Capitalising on the knowledge translation value of RCTs requires more than the standard reporting of trials. Those who are convinced by a trial and want to act, need to know how the trial relates to their own context, what contributed to success, and what might make it even more effective. Implementation research unpacks the back-story, examining how and why an intervention worked. The Camino Verde trial of community mobilisation for control of dengue reported a significant impact on entomological indices of the Aedes aegypti vector, and on serological dengue virus infection and self-reported dengue cases. This important study should lead to studies of similar interventions in other contexts, and ultimately to changes in dengue control practices. This supplement is the back-story of the trial, providing information to help researchers and planners to make use of the trial findings. Background articles include the full protocol, a systematic review of CRCTs of approaches for Aedes aegypti control, epidemiological and entomological findings from the baseline survey, and how baseline findings were used to set up the intervention. Secondary analyses of the entomological findings examine associations with the use of the larvicide temephos, and the impact of the intervention in different conditions of water supply and seasons. Other articles

  11. Effect of nitrous oxide on pain due to rocuronium injection: A randomised, double-blind, controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Sonal Sharma

    2010-01-01

    Full Text Available A prospective, randomised, double-blind, placebo-controlled study was carried out to determine the effect of nitrous oxide (N 2 O on the frequency and severity of pain and withdrawal reactions after injection of rocuronium. Eighty ASA physical status I and II patients undergoing general anaesthesia for elective surgery were enrolled. The patients were randomised to receive 100% oxygen (O 2 , or 50% N 2 O in O 2 for 3 minutes followed by a subparalysing dose of rocuronium 0.06 mg/kg. After induction of anaesthesia with thiopentone 5 mg/kg, an intubating dose of rocuronium 0.6 mg/kg was given. The patients were observed after injection of rocuronium 0.06 mg/kg, and asked to rate pain in the arm on a 4-point (0-3 verbal rating scale (none, mild, moderate or severe. After the intubating dose of rocuronium, withdrawal reactions were recorded. Thirty-six patients (90% in the group N 2 O and 15 patients (37.5% in the group O 2 reported no pain (P < 0.001. The pain was mild in 1 (2.5% and 9 (22.5% patients in N 2 O and O 2 groups, respectively (P = 0.006. Moderate pain occurred in 2 (5% patients in group N 2 O and 15 (37.5% patients in group O 2 (P = 0.001. Severe pain was reported by one patient in each group (P = 0.47. Withdrawal response after an intubating dose of rocuronium was observed in 6 (15% and 18 (45% patients in the N 2 O and O 2 groups, respectively (P < 0.05. Inhalation of 50% N 2 O in O 2 reduces the incidence and severity of pain and the withdrawal reactions associated with rocuronium injection.

  12. Nixtamalización de cinco variedades de maíz con diferente dureza de grano: impacto en consumo de combustible y cambios fisicoquímicos

    OpenAIRE

    Roque-Maciel, Laura; Arámbula-Villa, Gerónimo; López-Espíndola, Mirna; Ortiz-Laurel, Hipólito; Carballo-Carballo, Aquiles; Herrera-Corredor, J. Andrés

    2016-01-01

    Resumen La nixtamalización causa en el grano de maíz cambios físicos, químicos y reológicos que afectan la calidad de la masa y la tortilla. La nixtamalización tradicional de maíz, realizada principalmente en contenedores abiertos, presenta una muy baja utilización de la energía requerida para este proceso, porque puede usar hasta 70 % más del combustible necesario. La correcta selección de los maíces para nixtamalizar contribuye en la calidad de las tortillas y el ahorro de combustible. El o...

  13. A randomised controlled trial of adjunctive yoga and adjunctive physical exercise training for cognitive dysfunction in schizophrenia.

    Science.gov (United States)

    Bhatia, Triptish; Mazumdar, Sati; Wood, Joel; He, Fanyin; Gur, Raquel E; Gur, Ruben C; Nimgaonkar, Vishwajit L; Deshpande, Smita N

    2017-04-01

    Yoga and physical exercise have been used as adjunctive intervention for cognitive dysfunction in schizophrenia (SZ), but controlled comparisons are lacking. Aims A single-blind randomised controlled trial was designed to evaluate whether yoga training or physical exercise training enhance cognitive functions in SZ, based on a prior pilot study. Consenting, clinically stable, adult outpatients with SZ (n=286) completed baseline assessments and were randomised to treatment as usual (TAU), supervised yoga training with TAU (YT) or supervised physical exercise training with TAU (PE). Based on the pilot study, the primary outcome measure was speed index for the cognitive domain of 'attention' in the Penn computerised neurocognitive battery. Using mixed models and contrasts, cognitive functions at baseline, 21 days (end of training), 3 and 6 months post-training were evaluated with intention-to-treat paradigm. Speed index of attention domain in the YT group showed greater improvement than PE at 6 months follow-up (pattention domain showed greater improvement than TAU alone at 6-month follow-up (pattention and additional cognitive domains well past the training period, supporting our prior reported beneficial effect of YT on speed index of attention domain. As adjuncts, YT or PE can benefit individuals with SZ.

  14. Haemodynamic-guided fluid administration for the prevention of contrast-induced acute kidney injury: the POSEIDON randomised controlled trial.

    Science.gov (United States)

    Brar, Somjot S; Aharonian, Vicken; Mansukhani, Prakash; Moore, Naing; Shen, Albert Y-J; Jorgensen, Michael; Dua, Aman; Short, Lindsay; Kane, Kevin

    2014-05-24

    The administration of intravenous fluid remains the cornerstone treatment for the prevention of contrast-induced acute kidney injury. However, no well-defined protocols exist to guide fluid administration in this treatment. We aimed to establish the efficacy of a new fluid protocol to prevent contrast-induced acute kidney injury. In this randomised, parallel-group, comparator-controlled, single-blind phase 3 trial, we assessed the efficacy of a new fluid protocol based on the left ventricular end-diastolic pressure for the prevention of contrast-induced acute kidney injury in patients undergoing cardiac catheterisation. The primary outcome was the occurrence of contrast-induced acute kidney injury, which was defined as a greater than 25% or greater than 0·5 mg/dL increase in serum creatinine concentration. Between Oct 10, 2010, and July 17, 2012, 396 patients aged 18 years or older undergoing cardiac catheterisation with an estimated glomerular filtration rate of 60 mL/min per 1·73 m(2) or less and one or more of several risk factors (diabetes mellitus, history of congestive heart failure, hypertension, or age older than 75 years) were randomly allocated in a 1:1 ratio to left ventricular end-diastolic pressure-guided volume expansion (n=196) or the control group (n=200) who received a standard fluid administration protocol. Four computer-generated concealed randomisation schedules, each with permuted block sizes of 4, were used for randomisation, and participants were allocated to the next sequential randomisation number by sealed opaque envelopes. Patients and laboratory personnel were masked to treatment assignment, but the physicians who did the procedures were not masked. Both groups received intravenous 0·9% sodium chloride at 3 mL/kg for 1 h before cardiac catheterisation. Analyses were by intention to treat. Adverse events were assessed at 30 days and 6 months and all such events were classified by staff who were masked to treatment assignment. This

  15. Skills Training to Avoid Inadvertent Plagiarism: Results from a Randomised Control Study

    Science.gov (United States)

    Newton, Fiona J.; Wright, Jill D.; Newton, Joshua D.

    2014-01-01

    Plagiarism continues to be a concern within academic institutions. The current study utilised a randomised control trial of 137 new entry tertiary students to assess the efficacy of a scalable short training session on paraphrasing, patch writing and plagiarism. The results indicate that the training significantly enhanced students' overall…

  16. Psychosocial consequences in the Danish randomised controlled lung cancer screening trial (DLCST)

    DEFF Research Database (Denmark)

    F. Rasmussen, Jakob; Siersma, V.; H. Pedersen, J.

    2015-01-01

    on Airway Symptoms, Stigmatisation, Introvert, and Harm of Smoking. Results: 4104 participants were randomised to the DLCST and the COS-LC completion rates for the CT group and the control group were 95.5% and 73.6%, respectively. There was a significant increase in negative psychosocial consequences from...

  17. Exposure-based cognitive-behavioural therapy via the internet and as bibliotherapy for somatic symptom disorder and illness anxiety disorder: randomised controlled trial.

    Science.gov (United States)

    Hedman, Erik; Axelsson, Erland; Andersson, Erik; Lekander, Mats; Ljótsson, Brjánn

    2016-11-01

    In DSM-5 two new diagnoses, somatic symptom disorder (SSD) and illness anxiety disorder (IAD), have replaced DSM-IV hypochondriasis. There are no previous treatment studies for these disorders. Cognitive-behavioural therapy (CBT) delivered as therapist-guided or unguided internet treatment or as unguided bibliotherapy could be used to increase treatment accessibility. To investigate the effect of CBT delivered as guided internet treatment (ICBT), unguided internet treatment (U-ICBT) and as unguided bibliotherapy. A randomised controlled trial (RCT) where participants (n = 132) with a diagnosis of SSD or IAD were randomised to ICBT, U-ICBT, bibliotherapy or to a control condition on a waiting list (trial registration: Clinicaltrials.gov identifier NCT01966705). Compared with the control condition, all three treatment groups made large and significant improvements on the primary outcome Health Anxiety Inventory (between-group d at post-treatment was 0.80-1.27). ICBT, U-ICBT and bibliotherapy can be highly effective in the treatment of SSD and IAD. This is the first study showing that these new DSM-5 disorders can be effectively treated. © The Royal College of Psychiatrists 2016.

  18. Estudio comparativo del maíz morado (Zea mays L. y simvastatina en la reducción de lípidos séricos de pacientes diabéticos normotensos con dislipidemia

    Directory of Open Access Journals (Sweden)

    Gerardo Ronceros

    2012-04-01

    , triglicéridos y aumento estadísticamente significativo del colesterol HDL, en comparación con los valores basales. El maíz morado mostró optimizar el control de la glucosa, efecto muy superior y estadísticamente significativo en comparación con la simvastatina. Se encontró diferencia estadísticamente significativa para los valores postratamiento de colesterol total, colesterol LDL, colesterol HDL y triglicéridos a favor del grupo que recibió simvastatina en comparación con el que recibió maíz morado. Conclusiones: A la dosis estudiada, el maíz morado mostró ser eficaz para reducir los niveles de triglicéridos, aumentar el colesterol HDL y optimizar el control de la glucosa en pacientes diabéticos no hipertensos. Simvastatina fue más eficaz que el maíz morado en el tratamiento de la dislipidemia, sin efectos importantes sobre la glicemia.

  19. Physiotherapy Post Lumbar Discectomy: Prospective Feasibility and Pilot Randomised Controlled Trial

    Science.gov (United States)

    Rushton, Alison; Goodwin, Peter C.

    2015-01-01

    Objectives To evaluate: acceptability and feasibility of trial procedures; distribution of scores on the Roland Morris Disability Questionnaire (RMDQ, planned primary outcome); and efficient working of trial components. Design and Setting A feasibility and external pilot randomised controlled trial (ISRCTN33808269, assigned 10/12/2012) was conducted across 2 UK secondary care outpatient physiotherapy departments associated with regional spinal surgery centres. Participants Consecutive consenting patients aged >18 years; post primary, single level, lumbar discectomy. Interventions Participants were randomised to either 1:1 physiotherapy outpatient management including patient leaflet, or patient leaflet alone. Main Outcome Measures Blinded assessments were made at 4 weeks post surgery (baseline) and 12 weeks post baseline (proposed primary end point). Secondary outcomes included: Global Perceived Effect, back/leg pain, straight leg raise, return to work/function, quality of life, fear avoidance, range of movement, medication, re-operation. Results At discharge, 110 (44%) eligible patients gave consent to be contacted. 59 (54%) patients were recruited. Loss to follow up was 39% at 12 weeks, with one site contributing 83% losses. Mean (SD) RMDQ was 10.07 (5.58) leaflet and 10.52 (5.94) physiotherapy/leaflet at baseline; and 5.37 (4.91) leaflet and 5.53 (4.49) physiotherapy/leaflet at 12 weeks. 5.1% zero scores at 12 weeks illustrated no floor effect. Sensitivity to change was assessed at 12 weeks with mean (SD) change -4.53 (6.41), 95%CI -7.61 to -1.44 for leaflet; and -6.18 (5.59), 95%CI -9.01 to -3.30 for physiotherapy/leaflet. RMDQ mean difference (95%CI) between change from baseline to twelve weeks was 1.65(-2.46 to 5.75). Mean difference (95%CI) between groups at 12 weeks was -0.16 (-3.36 to 3.04). Participant adherence with treatment was good. No adverse events were reported. Conclusions Both interventions were acceptable, and it is promising that they both

  20. Laparoscopic elective cholecystectomy with and without drain: A controlled randomised trial

    Directory of Open Access Journals (Sweden)

    Gouda El-labban

    2012-01-01

    Full Text Available Background : Laparoscopic cholecystectomy is the main method of treatment of symptomatic gallstones. Routine drainage after laparoscopic cholecystectomy is an issue of considerable debate. Therefore, a controlled randomised trial was designed to assess the value of drains in elective laparoscopic cholecystectomy. Materials and Methods: During a two-year period (From April 2008 to January 2010, 80 patients were simply randomised to have a drain placed (group A, an 8-mm pentose tube drain was retained below the liver bed, whereas 80 patients were randomised not to have a drain (group B placed in the subhepatic space. End points of this trial were to detect any differences in morbidity, postoperative pain, wound infection and hospital stay between the two groups. Results : There was no mortality in either group and no statistically significant difference in postoperative pain, nausea and vomiting, wound infection or abdominal collection between the two groups. However, hospital stay was longer in the drain group than in group without drain and it is appearing that the use of drain delays hospital discharge. Conclusion : The routine use of a drain in non-complicated laparoscopic cholecystectomy has nothing to offer; in contrast, it is associated with longer hospital stay.

  1. The informed consent process in randomised controlled trials: a nurse-led process.

    Science.gov (United States)

    Cresswell, Pip; Gilmour, Jean

    2014-03-01

    Clinical trials are carried out with human participants to answer questions about the best way to diagnose, treat and prevent illness. Participants must give informed consent to take part in clinical trials that requires understanding of how clinical trials work and their purpose. Randomised controlled trials provide strong evidence but their complex design is difficult for both clinicians and participants to understand. Increasingly, ensuring informed consent in randomised controlled trials has become part of the clinical research nurse role. The aim of this study was to explore in depth the clinical research nurse role in the informed consent process using a qualitative descriptive approach. Three clinical research nurses were interviewed and data analysed using a thematic analysis approach. Three themes were identified to describe the process of ensuring informed consent. The first theme, Preparatory partnerships, canvassed the relationships required prior to initiation of the informed consent process. The second theme, Partnering the participant, emphasises the need for ensuring voluntariness and understanding, along with patient advocacy. The third theme, Partnership with the project, highlights the clinical research nurse contribution to the capacity of the trial to answer the research question through appropriate recruiting and follow up of participants. Gaining informed consent in randomised controlled trials was complex and required multiple partnerships. A wide variety of skills was used to protect the safety of trial participants and promote quality research. The information from this study contributes to a greater understanding of the clinical research nurse role, and suggests the informed consent process in trials can be a nurse-led one. In order to gain collegial, employer and industry recognition it is important this aspect of the nursing role is acknowledged.

  2. Informed consent, parental awareness, and reasons for participating in a randomised controlled study

    NARCIS (Netherlands)

    M. van Stuijvenberg (Margriet); M.H. Suur (Marja); S. de Vos (Sandra); G.C.H. Tjiang (Gilbert); E.W. Steyerberg (Ewout); G. Derksen-Lubsen (Gerarda); H.A. Moll (Henriëtte)

    1998-01-01

    textabstractBACKGROUND: The informed consent procedure plays a central role in randomised controlled trials but has only been explored in a few studies on children. AIM: To assess the quality of the informed consent process in a paediatric setting. METHODS: A

  3. Occupational therapy for elderly : evidence mapping of randomised controlled trials from 2004-2012

    NARCIS (Netherlands)

    Voigt-Radloff, S; Ruf, G.; Vogel, A.; van Nes, F.; Hüll, M.

    OBJECTIVE: Previous systematic reviews on occupational therapy for elderly included studies until 2003. The present evidence mapping summarizes recent evidence for the efficacy of occupational therapy with older persons based on randomised controlled trials from 2004-2012. METHOD: An electronic

  4. Internet delivered cognitive behavior therapy for antenatal depression: A randomised controlled trial.

    Science.gov (United States)

    Forsell, Erik; Bendix, Marie; Holländare, Fredrik; Szymanska von Schultz, Barbara; Nasiell, Josefine; Blomdahl-Wetterholm, Margareta; Eriksson, Caroline; Kvarned, Sara; Lindau van der Linden, Johanna; Söderberg, Elin; Jokinen, Jussi; Wide, Katarina; Kaldo, Viktor

    2017-10-15

    Major depression occurs in 5-10% of pregnancies and is associated with many negative effects for mother and child, yet treatment options are scarce. To our knowledge, this is the first published randomised controlled trial on Internet delivered Cognitive Behavior Therapy (ICBT) for this group. To test the efficacy of a pregnancy adapted version of an existing 10-week ICBT-program for depression as well as assessing acceptability and adherence DESIGN: Randomised controlled trial. Online and telephone. Self-referred pregnant women (gestational week 10-28 at intake) currently suffering from major depressive disorder. 42 pregnant women (gestational week 12-28) with major depression were randomised to either treatment as usual (TAU) provided at their antenatal clinic or to ICBT as an add-on to usual care. The primary outcome was depressive symptoms measured with the Montgomery-Åsberg depression rating scale-self report (MADRS-S). The Edinburgh Postnatal Depression Scale and measures of anxiety and sleep were used. Credibility, satisfaction, adherence and utilization were also assessed. The ICBT group had significantly lower levels of depressive symptoms post treatment (p treatment credibility, satisfaction, utilization, and adherence were comparable to implemented ICBT for depression. Small sample size and no long-term evaluation. Pregnancy adapted ICBT for antenatal depression is feasible, acceptable and efficacious. These results need to be replicated in larger trials to validate these promising findings. Copyright © 2017. Published by Elsevier B.V.

  5. Harms associated with taking nalmefene for substance use and impulse control disorders: A systematic review and meta-analysis of randomised controlled trials.

    Directory of Open Access Journals (Sweden)

    Karina Glies Vincents Johansen

    Full Text Available Nalmefene is a newly approved drug for alcohol use disorder, but the risk of harms has not been evaluated from empirical trial evidence.To assess the harm of nalmefene administered to individuals diagnosed with substance use or impulse control disorders by performing a systematic review and meta-analysis of randomised controlled trials.A search was performed in Cochrane Central Register of Controlled Trials (CENTRAL, 2014, MEDLINE via PubMed (1950, EMBASE via Ovid (1974, and Clinicaltrials.gov through December 2014.This study included only randomised controlled trials with placebo or active controls that administered nalmefene to adult individuals for treating impulse control and/or substance use disorders. Both published and unpublished randomised controlled trials were eligible for inclusion.Internal validity was assessed using the Cochrane risk-of-bias tool. Published information from the trials was supplemented by contact between reviewers and industry sponsor. Data were combined using two meta-approaches in fixed effects models; Peto Odds Ratios and risk differences were reported with 95% confidence intervals (95%CIs.Number of patients with serious adverse events, including specific psychiatric serious adverse events and withdrawals due to adverse events.Of 20 potentially relevant studies, 15 randomised controlled trials met the inclusion criteria, and 8 of these provided data enabling the meta-analysis. Overall, serious adverse events did not occur more often in the nalmefene group than in the placebo group (Peto Odds Ratio = 0.97 [95% CI 0.64-1.44]; P = 0.86. Risk of psychiatric serious adverse events was slightly elevated, albeit not at a statistically significant level (Peto Odds Ratio = 1.32 [95% CI 0.62, 2.83]; P = 0.47. Withdrawals due to adverse events were significantly more likely to occur with nalmefene compared to placebo (Peto Odds Ratio = 3.22 [95% CI 2.46-4.22]; P<0.001.The three-fold increased risk of withdrawal from

  6. Does hydrotherapy improve strength and physical function in patients with osteoarthritis--a randomised controlled trial comparing a gym based and a hydrotherapy based strengthening programme.

    Science.gov (United States)

    Foley, A; Halbert, J; Hewitt, T; Crotty, M

    2003-12-01

    To compare the effects of a hydrotherapy resistance exercise programme with a gym based resistance exercise programme on strength and function in the treatment of osteoarthritis (OA). Single blind, three arm, randomised controlled trial. 105 community living participants aged 50 years and over with clinical OA of the hip or knee. Participants were randomised into one of three groups: hydrotherapy (n = 35), gym (n = 35), or control (n = 35). The two exercising groups had three exercise sessions a week for six weeks. At six weeks an independent physiotherapist unaware of the treatment allocation performed all outcome assessments (muscle strength dynamometry, six minute walk test, WOMAC OA Index, total drugs, SF-12 quality of life, Adelaide Activities Profile, and the Arthritis Self-Efficacy Scale). In the gym group both left and right quadriceps significantly increased in strength compared with the control group, and right quadriceps strength was also significantly better than in the hydrotherapy group. The hydrotherapy group increased left quadriceps strength only at follow up, and this was significantly different from the control group. The hydrotherapy group was significantly different from the control group for distance walked and the physical component of the SF-12. The gym group was significantly different from the control group for walk speed and self efficacy satisfaction. Compliance rates were similar for both exercise groups, with 84% of hydrotherapy and 75% of gym sessions attended. There were no differences in drug use between groups over the study period. Functional gains were achieved with both exercise programmes compared with the control group.

  7. Empoderamiento y feminismo comunitario en la conservación del maíz en México

    Directory of Open Access Journals (Sweden)

    Ana Gabriela Rincón Rubio

    2017-10-01

    Full Text Available El objetivo es analizar, desde una perspectiva basada en el feminismo comunitario, el proceso de empoderamiento de las mujeres que conforman un grupo de ocho integrantes matlatzincas de la comunidad de San Francisco Oxtotilpan, México, a través de prácticas productivas, alimentarias y culturales en torno al maíz nativo. Los datos fueron recogidos durante 2014 y 2015 con técnicas etnográficas que incluyen: observación participante, historias de vida, grupos focales, entrevistas semiestructuradas y a profundidad. Son mujeres que muestran cinco dimensiones de poder (social, corporal, material, simbólico y cognitivo que repercuten en la preservación del maíz nativo, al generar la masa crítica necesaria para incorporar a otras mujeres en acciones favorables para la soberanía alimentaria.

  8. Lovastatin for adult patients with dengue: protocol for a randomised controlled trial

    Science.gov (United States)

    2012-01-01

    Background Dengue is the most important vector-borne viral infection of man, with approximately 2 billion people living in areas at risk. Infection results in a range of manifestations from asymptomatic infection through to life-threatening shock and haemorrhage. One of the hallmarks of severe dengue is vascular endothelial disruption. There is currently no specific therapy and clinical management is limited to supportive care. Statins are a class of drug initially developed for lipid lowering. There has been considerable recent interest in their effects beyond lipid lowering. These include anti-inflammatory effects at the endothelium. In addition, it is possible that lovastatin may have an anti-viral effect against dengue. Observational data suggest that the use of statins may improve outcomes for such conditions as sepsis and pneumonia. This paper describes the protocol for a randomised controlled trial investigating a short course of lovastatin therapy in adult patients with dengue. Methods/design A randomised, double-blind, placebo-controlled trial will investigate the effects of lovastatin therapy in the treatment of dengue. The trial will be conducted in two phases with an escalation of dose between phases if an interim safety review is satisfactory. This is an exploratory study focusing on safety and there are no data on which to base a sample size calculation. A target sample size of 300 patients in the second phase, enrolled over two dengue seasons, was chosen based on clinical judgement and feasibility considerations. In a previous randomised trial in dengue, about 10% and 30% of patients experienced at least one serious adverse event or adverse event, respectively. With 300 patients, we will have 80% power to detect an increase of 12% (from 10% to 22%) or 16% (from 30% to 46%) in the frequency of adverse events. Furthermore, this sample size ensures some power to explore the efficacy of statins. Discussion The development of a dengue therapeutic that can

  9. Infant wellbeing at 2 years of age in the Growth Restriction Intervention Trial (GRIT): multicentred randomised controlled trial.

    Science.gov (United States)

    Thornton, J G; Hornbuckle, J; Vail, A; Spiegelhalter, D J; Levene, M

    Although delivery is widely used for preterm babies failing to thrive in utero, the effect of altering delivery timing has never been assessed in a randomised controlled trial. We aimed to compare the effect of delivering early with delaying birth for as long as possible. 548 pregnant women were recruited by 69 hospitals in 13 European countries. Participants had fetal compromise between 24 and 36 weeks, an umbilical-artery doppler waveform recorded, and clinical uncertainty about whether immediate delivery was indicated. Before birth, 588 babies were randomly assigned to immediate delivery (n=296) or delayed delivery until the obstetrician was no longer uncertain (n=292). The main outcome was death or disability at or beyond 2 years of age. Disability was defined as a Griffiths developmental quotient of 70 or less or the presence of motor or perceptual severe disability. Analysis was by intention-to-treat. This trial has been assigned the International Standard Randomised Controlled Trial Number ISRCTN41358726. Primary outcomes were available on 290 (98%) immediate and 283 (97%) deferred deliveries. Overall rate of death or severe disability at 2 years was 55 (19%) of 290 immediate births, and 44 (16%) of 283 delayed births. With adjustment for gestational age and umbilical-artery doppler category, the odds ratio (95% CrI) was 1.1 (0.7-1.8). Most of the observed difference was in disability in babies younger than 31 weeks of gestation at randomisation: 14 (13%) immediate versus five (5%) delayed deliveries. No important differences in the median Griffiths developmental quotient in survivors was seen. The lack of difference in mortality suggests that obstetricians are delivering sick preterm babies at about the correct moment to minimise mortality. However, they could be delivering too early to minimise brain damage. These results do not lend support to the idea that obstetricians can deliver before terminal hypoxaemia to improve brain development.

  10. Evaluación de las Condiciones de Extrusión Necesarias para Elaborar Harina de Maíz con Características Similares a las de una Harina Nixtamalizada

    OpenAIRE

    Haller, Aníbal Darío

    2009-01-01

    Objetivos: obtener harinas precocidas de maíz por extrusión aptas para elaborar tortillas, desarrollar una metodología para su elaboración y analizar el efecto de la dureza del endospermo y las condiciones de extrusión sobre la harina extrudida y la aptitud para elaborar tortilla. Se utilizaron un maíz dentado (Pioner 30R76) y un colorado duro (Dekalb 764). Para la extrusión, se siguió un diseño tipo factorial, con la humedad de sémola (27 a 35%) y la temperatura (114 a 150º C) com...

  11. Effectiveness of physiotherapy in Parkinson's disease: the feasibility of a randomised controlled trial.

    NARCIS (Netherlands)

    Keus, S.H.J.; Bloem, B.R.; Hilten, J.J. van; Ashburn, A.; Munneke, M.

    2007-01-01

    To study the feasibility of a large randomised controlled trial (RCT) evaluating the effectiveness of physiotherapy in Parkinson's disease (PD), 173 patients were asked to participate in a study with random allocation to best practice physiotherapy, or to no physiotherapy. The primary outcome

  12. Prophylactic antibiotic regimens in tumour surgery (PARITY) : a pilot multicentre randomised controlled trial

    NARCIS (Netherlands)

    Ghert, M.; Bhandari, M.; Deheshi, B.; Guyatt, G.; Holt, G.; O'Shea, T.; Randall, R. L.; Thabane, L.; Wunder, J.; Evaniew, N.; McKay, P.; Schneider, P.; Turcotte, R.; Madden, K.; Scott, T.; Sprague, S.; Simunovic, N.; Swinton, M.; Racano, A.; Heels-Ansdell, D.; Buckingham, L.; Rose, P.; Brigman, B.; Pullenayegum, E.; Ghert, M.; Evaniew, N.; Mckay, P.; Schneider, P.; Sobhi, G.; Chan, R.; Biljan, M.; Ferguson, P.; Wunder, J.; Griffin, A.; Mantas, I.; Wylie, A.; Han, A.; Grewal, G.; Turcotte, R.; Goulding, K.; Dandachli, F.; Matte, G.; Werier, J.; Abdelbary, H.; Paquin, K.; Cosgrove, H.; Dugal, A-M.; Jutte, P.; Ploegmakers, J. J. W.; Stevens, M.

    2015-01-01

    Objective Clinical studies of patients with bone sarcomas have been challenged by insufficient numbers at individual centres to draw valid conclusions. Our objective was to assess the feasibility of conducting a definitive multi-centre randomised controlled trial (RCT) to determine whether a

  13. Supervised physical exercise during pregnancy improves health perception. Randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Mireia Peláez

    2013-07-01

    Full Text Available Aim: To investigate the influence of a moderate exercise program during pregnancy on the maternal health perception. Methods. A randomised controlled trial was performed. 101 primiparous women were allocated into the control group (CG, n=51 and the exercise group (EG, n=50, lost to follow-up 13, 11.4%. Women on the EC were asked to participate in a supervised exercise program during from 10-14 to 36 weeks of gestation (70-75 sessions, 55-60 min/session, three times per week. Women in the CG received usual care. All women were asked to fill in validated questionnaires about health perception and urinary incontinence before and after the intervention. Results. At the end of the intervention there were statistically significant differences between groups on health perception [very good: EG 35, 70% vs. CG 5, 9.8%; good: EG 15, 30% vs. CG 16, 31%; average EG 0, 0.0% vs. CG 26, 51%; poor EG 0, 0.0% vs. CG 3, 5.9%; very poor: EG 0, 0.0% vs. CG 1, 2% (p<.001]. What is more, women in the EG showed less urinary incontinence [ICIQ-SF Score EG 0.30 (SD1.3 vs. CG 3.1 (SD4.1, p<.001]. Conclusions. A supervised physical exercise program during pregnancy which includes pelvic floor muscle training, improves health perception and it is effective on primary prevention of urinary incontinence.

  14. Effectiveness of online self-help for suicidal thoughts: results of a randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Bregje A J van Spijker

    Full Text Available Many people with suicidal thoughts do not receive treatment. The Internet can be used to reach more people in need of support.To test the effectiveness of unguided online self-help to reduce suicidal thoughts.236 adults with mild to moderate suicidal thoughts were randomised to the intervention (n=116 or a waitlist control group (n=120. Assessments took place at baseline, and 2, 4 and 6 weeks later. Primary outcome was suicidal thoughts. Secondary outcomes were depressive symptoms, anxiety, hopelessness, worry, and health status.The intervention group showed a small significant effect in reducing suicidal thoughts (d=0.28. Effects were more pronounced for those with a history of repeated suicide attempts. There was also a significant reduction in worry (d=0.33. All other secondary outcomes showed small but non-significant improvements.Although effect sizes were small, the reach of the internet could enable this intervention to help many people reduce their suicidal thoughts.Netherlands Trial Register NTR1689.

  15. Delivering prevention for alcohol and cannabis using the Internet: a cluster randomised controlled trial.

    Science.gov (United States)

    Newton, Nicola C; Andrews, Gavin; Teesson, Maree; Vogl, Laura E

    2009-06-01

    To establish the efficacy of an internet based prevention program to reduce alcohol and cannabis use in adolescents. A cluster randomised controlled trial was conducted with 764 13-year olds from ten Australian secondary schools in 2007-2008. Half the schools were randomly allocated to the computerised prevention program (n=397), and half to their usual health classes (n=367). The Climate Schools: Alcohol and Cannabis prevention course is facilitated by the internet and consists of novel, evidence-based, curriculum consistent lessons aimed at reducing alcohol and cannabis use. Participants were assessed at baseline, immediately post, and at six months following the intervention. Compared to the control group, students in the intervention group showed significant improvements in alcohol and cannabis knowledge at the end of the course and the six month follow-up. In addition, the intervention group showed a reduction in average weekly alcohol consumption and frequency of cannabis use at the six month follow-up. No differences between groups were found on alcohol expectancies, cannabis attitudes, or alcohol and cannabis related harms. The course is acceptable, scalable and fidelity is assured. It increased knowledge regarding alcohol and cannabis, and decreased use of these drugs.

  16. A self-managed single exercise programme versus usual physiotherapy treatment for rotator cuff tendinopathy: a randomised controlled trial (the SELF study).

    Science.gov (United States)

    Littlewood, Chris; Bateman, Marcus; Brown, Kim; Bury, Julie; Mawson, Sue; May, Stephen; Walters, Stephen J

    2016-07-01

    To evaluate the clinical effectiveness of a self-managed single exercise programme versus usual physiotherapy treatment for rotator cuff tendinopathy. Multi-centre pragmatic unblinded parallel group randomised controlled trial. UK National Health Service. Patients with a clinical diagnosis of rotator cuff tendinopathy. The intervention was a programme of self-managed exercise prescribed by a physiotherapist in relation to the most symptomatic shoulder movement. The control group received usual physiotherapy treatment. The primary outcome measure was the Shoulder Pain & Disability Index (SPADI) at three months. Secondary outcomes included the SPADI at six and twelve months. A total of 86 patients (self-managed loaded exercise n=42; usual physiotherapy n=44) were randomised. Twenty-six patients were excluded from the analysis because of lack of primary outcome data at the 3 months follow-up, leaving 60 (n=27; n=33) patients for intention to treat analysis. For the primary outcome, the mean SPADI score at three months was 32.4 (SD 20.2) for the self-managed group, and 30.7 (SD 19.7) for the usual physiotherapy treatment group; mean difference adjusted for baseline score: 3.2 (95% Confidence interval -6.0 to +12.4 P = 0.49).By six and twelve months there remained no significant difference between the groups. This study does not provide sufficient evidence of superiority of one intervention over the other in the short-, mid- or long-term and hence a self-management programme based around a single exercise appears comparable to usual physiotherapy treatment. © The Author(s) 2015.

  17. 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

  18. Supported Discharge Teams for older people in hospital acute care: a randomised controlled trial.

    Science.gov (United States)

    Parsons, Matthew; Parsons, John; Rouse, Paul; Pillai, Avinesh; Mathieson, Sean; Parsons, Rochelle; Smith, Christine; Kenealy, Tim

    2018-03-01

    Supported Discharge Teams aim to help with the transition from hospital to home, whilst reducing hospital length-of-stay. Despite their obvious attraction, the evidence remains mixed, ranging from strong support for disease-specific interventions to less favourable results for generic services. To determine whether older people referred to a Supported Discharge Team have: (i) reduced length-of-stay in hospital; (ii) reduced risk of hospital readmission; and (iii) reduced healthcare costs. Randomised controlled trial with follow-up to 6 months; 103 older women and 80 men (n = 183) (mean age 79), in hospital, were randomised to receive either Supported Discharge Team or usual care. Home-based rehabilitation was delivered by trained Health Care Assistants up to four times a day, 7 days a week, under the guidance of registered nurses, allied health and geriatricians for up to 6 weeks. Participants randomised to the Supported Discharge Team spent less time in hospital during the index admission (mean 15.7 days) in comparison to usual care (mean 21.6 days) (mean difference 5.9: 95% CI 0.6, 11.3 days: P = 0.03) and spent less time in hospital in the 6 months following discharge home. Supported discharge group costs were calculated at mean NZ$10,836 (SD NZ$12,087) compared to NZ$16,943 (SD NZ$22,303) in usual care. A Supported Discharge Team can provide an effective means of discharging older people home early from hospital and can make a cost-effective contribution to managing increasing demand for hospital beds. © The Author 2017. Published by Oxford University Press on behalf of the British Geriatrics Society.All rights reserved. For permissions, please email: journals.permissions@oup.com

  19. Producción de maíz con estrés hídrico provocado en diferentes etapas de desarrollo

    OpenAIRE

    Giménez, Luis

    2012-01-01

    El maíz es un cultivo de elevado potencial en producción de grano y es altamente sensible a las deficiencias ambientales. La disponibilidad hídrica es la principal limitante del ambiente que presenta Uruguay para el desarrollo de maíz, debido a la baja capacidad de almacenamiento de agua de los suelos, las elevadas demandas atmosféricas y la irregularidad de las precipitaciones (PP). El trabajo consistió en determinar los rendimientos de maíz en situaciones de bienestar hídrico (T1) y cuantif...

  20. Valoración del control de calidad de materiales en estructuras de edificación efectuado en Cantabria, en el quinquenio 1984-1988

    OpenAIRE

    Villegas Cabredo, Luis M.

    1990-01-01

    RESUMEN. Se recoge una integración de los datos relativos al control de calidad de materiales en estructuras de edificación suministrados por los Laboratorios que operan en la región de Cantabria durante el período 1984-88. Con estos datos y los que proporcionan las estadísticas de construcción (número de viviendas y metros cuadrados construidos) se hace una valoración del grado de cumplimiento de la Instrucción EH-88 para estructuras de hormigón en lo referente a su Capítulo IX Control de Ma...

  1. Art participation for psychosocial wellbeing during stroke rehabilitation: a feasibility randomised controlled trial.

    Science.gov (United States)

    Morris, Jacqui H; Kelly, Chris; Joice, Sara; Kroll, Thilo; Mead, Gillian; Donnan, Peter; Toma, Madalina; Williams, Brian

    2017-08-30

    To examine the feasibility of undertaking a pragmatic single-blind randomised controlled trial (RCT) of a visual arts participation programme to evaluate effects on survivor wellbeing within stroke rehabilitation. Stroke survivors receiving in-patient rehabilitation were randomised to receive eight art participation sessions (n = 41) or usual care (n = 40). Recruitment, retention, preference for art participation and change in selected outcomes were evaluated at end of intervention outcome assessment and three-month follow-up. Of 315 potentially eligible participants 81 (29%) were recruited. 88% (n = 71) completed outcome and 77% (n = 62) follow-up assessments. Of eight intervention group non-completers, six had no preference for art participation. Outcome completion varied between 97% and 77%. Running groups was difficult because of randomisation timing. Effectiveness cannot be determined from this feasibility study but effects sizes suggested art participation may benefit emotional wellbeing, measured on the positive and negative affect schedule, and self-efficacy for Art (d = 0.24-0.42). Undertaking a RCT of art participation within stroke rehabilitation was feasible. Art participation may enhance self-efficacy and positively influence emotional wellbeing. These should be outcomes in a future definitive trial. A cluster RCT would ensure art groups could be reliably convened. Fewer measures, and better retention strategies are required. Implications for Rehabilitation This feasibility randomised controlled trial (RCT) showed that recruiting and retaining stroke survivors in an RCT of a visual arts participation intervention within stroke rehabilitation was feasible. Preference to participate in art activities may influence recruitment and drop-out rates, and should be addressed and evaluated fully. Art participation as part of rehabilitation may improve some aspects of post-stroke wellbeing, including positive affect and self-efficacy for art

  2. Low sodium diet and pregnancy-induced hypertension: a multi-centre randomised controlled trial

    NARCIS (Netherlands)

    Knuist, M.; Bonsel, G. J.; Zondervan, H. A.; Treffers, P. E.

    1998-01-01

    To examine the effectiveness of the standard policy in the Netherlands to prescribe a sodium restricted diet to prevent or to treat mild pregnancy-induced hypertension. Multi-centre randomised controlled trial between April 1992 and April 1994. Seven practices of independent midwives and one

  3. Melatonin for chronic whiplash syndrome with delayed melatonin onset randomised, placebo-controlled trial

    NARCIS (Netherlands)

    Wieringen, S. van; Jansen, T.; Smits, M.G.; Nagtegaal, J.E.; Coenen, A.M.L.

    2001-01-01

    Objective: To assess the influence of melatonin in patients with chronic whiplash syndrome and delayed melatonin onset. Design: Randomised, double-blind, placebo-controlled, parallel-group trial. One-week baseline was followed by a 4-week treatment period with either melatonin or placebo. In the

  4. A randomised, controlled clinical study on total hip arthroplasty using 4 different bearings

    DEFF Research Database (Denmark)

    Borgwardt, Arne; Zerahn, Bo; Fabricius, Sandra D

    2017-01-01

    PURPOSE: To compare 4 different bearings in total hip arthroplasty (THA) in a randomised controlled clinical study on clinical performance. METHODS: 393 patients with osteoarthritis of the hip or avascular necrosis were included and allocated to 1 of the head-and-cup couples zirconia...

  5. Tectono-volcanic control of fissure type vents for the 28 Ma Panalillo ignimbrite in the Villa de Reyes Graben, San Luis PotosI, Mexico

    International Nuclear Information System (INIS)

    Tristan-Gonzalez, Margarito; Labarthe-Hernandez, Guillermo; Aguillon-Robles, Alfredo; Aguirre-DIaz, Gerardo J

    2008-01-01

    The volcano-tectonic events at the Villa de Reyes Graben (VRG), in the southern Sierra Madre Occidental, Mexico, include 1) a regional NNE fault system developed before 32 Ma, 2) this pre-32 Ma faulting controlled the emplacement of 31.5 Ma dacitic domes, 3) NE faulting at 28 Ma that displaced the 31.5 Ma dacitic domes and formed the VRG, as well as the oblique grabens of Bledos and Enramadas oriented NW, 4) emplacement of Panalillo ignimbrite at 28 Ma filling the VRG and erupting from fissures related to the oblique grabens, and eruption of Placa basalt apparently also from fault-controlled vents.

  6. Tectono-volcanic control of fissure type vents for the 28 Ma Panalillo ignimbrite in the Villa de Reyes Graben, San Luis PotosI, Mexico

    Energy Technology Data Exchange (ETDEWEB)

    Tristan-Gonzalez, Margarito; Labarthe-Hernandez, Guillermo; Aguillon-Robles, Alfredo [Instituto de Geologia/DES IngenierIa, UASLP, Av. Dr. Manuel Nava 5, Zona Universitaria, C.P. 78240, San Luis PotosI, S.L.P. (Mexico); Aguirre-DIaz, Gerardo J [Centro de Geociencias, Universidad Nacional Autonoma de Mexico, Campus Juriquilla, Queretaro, 76230 (Mexico)], E-mail: mtiistan@uasln.mx, E-mail: ger@geociencias.unam.mx

    2008-10-01

    The volcano-tectonic events at the Villa de Reyes Graben (VRG), in the southern Sierra Madre Occidental, Mexico, include 1) a regional NNE fault system developed before 32 Ma, 2) this pre-32 Ma faulting controlled the emplacement of 31.5 Ma dacitic domes, 3) NE faulting at 28 Ma that displaced the 31.5 Ma dacitic domes and formed the VRG, as well as the oblique grabens of Bledos and Enramadas oriented NW, 4) emplacement of Panalillo ignimbrite at 28 Ma filling the VRG and erupting from fissures related to the oblique grabens, and eruption of Placa basalt apparently also from fault-controlled vents.

  7. Randomised controlled trial of biofeedback training in persistent encopresis with anismus

    OpenAIRE

    Nolan, T.; Catto-Smith, T.; Coffey, C.; Wells, J.

    1998-01-01

    BACKGROUND—Paradoxical external anal sphincter contraction during attempted defecation (anismus) is thought to be an important contributor to chronic faecal retention and encopresis in children. Biofeedback training can be used to teach children to abolish this abnormal contraction.
METHODS—A randomised controlled trial in medical treatment resistant and/or treatment dependent children with anismus using surface electromyographic (EMG) biofeedback training to determine wh...

  8. Randomised controlled trials of homeopathy in humans: characterising the research journal literature for systematic review.

    Science.gov (United States)

    Mathie, Robert T; Hacke, Daniela; Clausen, Jürgen; Nicolai, Ton; Riley, David S; Fisher, Peter

    2013-01-01

    A new programme of systematic reviews of randomised controlled trials (RCTs) in homeopathy will distinguish important attributes of RCT records, including: placebo controlled versus other-than-placebo (OTP) controlled; individualised versus non-individualised homeopathy; peer-reviewed (PR) versus non peer-reviewed (NPR) sources. (a) To outline the methods used to search and categorise the RCT literature; (b) to report details of the records retrieved; (c) to compare our retrieved records with those reported in two previous systematic reviews (Linde et al., 1997; Shang et al., 2005). Ten major electronic databases were searched for records published up to the end of 2011. A record was accepted for subsequent systematic review if it was a substantive report of a clinical trial of homeopathic treatment or prophylaxis in humans, randomised and controlled, and published in a PR or NPR journal. 489 records were potentially eligible: 226 were rejected as non-journal, minor or repeat publications, or lacking randomisation and/or controls and/or a 'homeopathic' intervention; 263 (164 PR, 99 NPR) were acceptable for systematic review. The 263 accepted records comprised 217 (137 PR, 80 NPR) placebo-controlled RCTs, of which 121 were included by, 66 were published after, and 30 were potentially eligible for, but not listed by, Linde or Shang. The 137 PR records of placebo-controlled RCTs comprise 41 on individualised homeopathy and 96 on non-individualised homeopathy. Our findings clarify the RCT literature in homeopathy. The 263 accepted journal papers will be the basis for our forthcoming programme of systematic reviews. Copyright © 2012 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

  9. Influence of vitamin E supplementation on glycaemic control: a meta-analysis of randomised controlled trials.

    Directory of Open Access Journals (Sweden)

    Renfan Xu

    Full Text Available Observational studies have revealed that higher serum vitamin E concentrations and increased vitamin E intake and vitamin E supplementation are associated with beneficial effects on glycaemic control in type 2 diabetes mellitus (T2DM. However, whether vitamin E supplementation exerts a definitive effect on glycaemic control remains unclear. This article involves a meta-analysis of randomised controlled trials of vitamin E to better characterise its impact on HbA1c, fasting glucose and fasting insulin. PubMed, EMBASE and the Cochrane Library were electronically searched from the earliest possible date through April 2013 for all relevant studies. Weighted mean difference (WMD was calculated for net changes using fixed-effects or random-effects models. Standard methods for assessing statistical heterogeneity and publication bias were used. Fourteen randomised controlled trials involving individual data on 714 subjects were collected in this meta-analysis. Increased vitamin E supplementation did not result in significant benefits in glycaemic control as measured by reductions in HbA1c, fasting glucose and fasting insulin. Subgroup analyses revealed a significant reduction in HbA1c (-0.58%, 95% CI -0.83 to -0.34 and fasting insulin (-9.0 pmol/l, 95% CI -15.90 to -2.10 compared with controls in patients with low baseline vitamin E status. Subgroup analyses also demonstrated that the outcomes may have been influenced by the vitamin E dosage, study duration, ethnic group, serum HbA1c concentration, and fasting glucose control status. In conclusion, there is currently insufficient evidence to support a potential beneficial effect of vitamin E supplementation on improvements of HbA1c and fasting glucose and insulin concentrations in subjects with T2DM.

  10. Influence of vitamin E supplementation on glycaemic control: a meta-analysis of randomised controlled trials.

    Science.gov (United States)

    Xu, Renfan; Zhang, Shasha; Tao, Anyu; Chen, Guangzhi; Zhang, Muxun

    2014-01-01

    Observational studies have revealed that higher serum vitamin E concentrations and increased vitamin E intake and vitamin E supplementation are associated with beneficial effects on glycaemic control in type 2 diabetes mellitus (T2DM). However, whether vitamin E supplementation exerts a definitive effect on glycaemic control remains unclear. This article involves a meta-analysis of randomised controlled trials of vitamin E to better characterise its impact on HbA1c, fasting glucose and fasting insulin. PubMed, EMBASE and the Cochrane Library were electronically searched from the earliest possible date through April 2013 for all relevant studies. Weighted mean difference (WMD) was calculated for net changes using fixed-effects or random-effects models. Standard methods for assessing statistical heterogeneity and publication bias were used. Fourteen randomised controlled trials involving individual data on 714 subjects were collected in this meta-analysis. Increased vitamin E supplementation did not result in significant benefits in glycaemic control as measured by reductions in HbA1c, fasting glucose and fasting insulin. Subgroup analyses revealed a significant reduction in HbA1c (-0.58%, 95% CI -0.83 to -0.34) and fasting insulin (-9.0 pmol/l, 95% CI -15.90 to -2.10) compared with controls in patients with low baseline vitamin E status. Subgroup analyses also demonstrated that the outcomes may have been influenced by the vitamin E dosage, study duration, ethnic group, serum HbA1c concentration, and fasting glucose control status. In conclusion, there is currently insufficient evidence to support a potential beneficial effect of vitamin E supplementation on improvements of HbA1c and fasting glucose and insulin concentrations in subjects with T2DM.

  11. Randomised controlled trial of expressive writing and quality of life in men and women treated for colon or rectal cancer.

    Science.gov (United States)

    Lepore, Stephen J; Revenson, Tracey A; Roberts, Katherine J; Pranikoff, Julie R; Davey, Adam

    2015-01-01

    This randomised trial tested (i) whether a home-based expressive writing (EW) intervention improves quality of life in patients with colorectal cancer (CRC) and (ii) whether the intervention is more beneficial for men or for people who feel constrained in disclosing cancer-related concerns and feelings. Patients treated for CRC were randomised to an EW (n = 101) or control writing (CW; n = 92) group. Assessments were completed at 1 month pre- and post-intervention. Sex and perceived social constraints on disclosure were evaluated as moderators. Primary outcomes were depressive symptoms, sleep problems and quality of life indicators. Eighty-one per cent of participants completed all writing assignments. Consistent with hypotheses, relative to the CW group, participants in the EW group expressed more negative emotion in writing and rated their writings as more meaningful, personal and emotionally revealing. There were no significant main effects of EW or moderating effects of sex or social constraints on outcomes. Although EW is feasible to use with persons who have CRC, it was not effective as a stand-alone psychotherapeutic intervention. Neither was it more effective for men nor for people who felt they could not freely disclose cancer-related concerns and feelings.

  12. Caracterización de agricultores de maíz en el estado de Chiapas, México

    OpenAIRE

    Sánchez, Blanca Isabel; Kallas, Zein; Gil Roig, José María

    2015-01-01

    México es uno de los países con mayor producción de maíz en el mundo (22.6 millones de toneladas), el estado de Chiapas cuenta con la mayor superficie sembrada. No obstante, históricamente los agricultores de esta zona se caracterizan por bajos rendimientos (2 tha-1) comparados con la media nacional. Las instituciones públicas se han planteado analizar estrategias y políticas para la adopción de semillas mejoradas que aumenten la eficiencia y producción del cultivo. Esta investigación pretend...

  13. Estimación del comportamiento de híbridos de maíz mediante modelos mixtos

    Directory of Open Access Journals (Sweden)

    C.A. Biasutti

    2012-12-01

    Full Text Available La selección de cultivares superiores se basa en el comportamiento de éstos en los llamados ensayos multiambientales. El problema de la correcta elección de cultivares se incrementa cuando estos ensayos dan lugar a datos fuertemente desbalanceados, sumado a la presencia de la interacción genotipo x ambiente. Para identificar los mejores cultivares se ha empleado la mejor predicción insesgada o BLUP, empleando modelos lineales mixtos para el análisis de datos fenotípicos unidos a datos de relaciones de parentesco. Los objetivos del presente trabajo fueron: estimar el comportamiento de híbridos de maíz partir de datos desbalanceados, con y sin la inclusión del parentesco genético, y determinar el poder predictivo de los años de evaluación sobre el comportamiento de los genotipos. Se emplearon datos de rendimiento de 49 híbridos de maíz, desde 2006 hasta 2009, para las estimaciones de los BLUPS de cada genotipo. La inclusión de las relaciones de coancestría en el cálculo de los BLUPs permitió una mejor discriminación del material genético. Para la correcta discriminación de híbridos es recomendable el empleo de los tBLUP basados en más de 2 años, incluyendo ambientes de evaluación donde los cultivares experimentales puedan expresar su potencial de rendimiento.

  14. Reducción del colesterol y aumento de la capacidad antioxidante por el consumo crónico de maíz morado (Zea mays L en ratas hipercolesterolémicas

    Directory of Open Access Journals (Sweden)

    Jorge Arroyo

    2007-04-01

    Full Text Available Objetivos: Determinar la actividad hipocolesterolémica y antioxidante del consumo crónico del extracto hidroalcohólico atomizado del maíz morado (Zea mays L en ratas hipercolesterolémicas. Materiales y métodos: Se utilizaron cinco grupos de seis ratas Holtzmann cada uno, uno sin hipercolesterolemia (control negativo, y cuatro con hipercolesterolemia inducida por consumo de colesterol puro vía oral durante 60 días: control positivo y tres para las dosis de 250, 500 y 1000 mg/kg, respectivamente. En el día 60 se determinaron los niveles séricos de colesterol total, triglicéridos y colesterol HDL (mg/dL, así como de malondialdehido (mmol/L para determinar la actividad antioxidante. Se comparó la diferencias de medias con ANOVA y test de Tukey. Resultados: Se observó una disminución del colesterol total en las ratas hipercolesterolémicas que consumieron dosis de 250 y 500 mg/kg en relación con el grupo control positivo (reducción de 21,5 y 11,2% respectivamente, p<0,01. No se observaron diferencias significativas sobre los niveles de triglicéridos y colesterol HDL. A mayor dosis se maíz morado se encontró una mayor reducción de radicales libres, con la dosis de 1000 mg/kg se redujo en 56,4% los niveles de malondialdehido (p< 0,01. Conclusiones: En condiciones experimentales, el consumo crónico del extracto hidroalcohólico atomizado de maíz morado disminuye los niveles de colesterol total y aumenta la capacidad antioxidante.

  15. Model for Analysis of the Energy Demand (MAED) users' manual for version MAED-1

    International Nuclear Information System (INIS)

    1986-09-01

    This manual is organized in two major parts. The first part includes eight main sections describing how to use the MAED-1 computer program and the second one consists of five appendices giving some additional information about the program. Concerning the main sections of the manual, Section 1 gives a summary description and some background information about the MAED-1 model. Section 2 extends the description of the MAED-1 model in more detail. Section 3 introduces some concepts, mainly related to the computer requirements imposed by the program, that are used throughout this document. Sections 4 to 7 describe how to execute each of the various programs (or modules) of the MAED-1 package. The description for each module shows the user how to prepare the control and data cards needed to execute the module and how to interpret the printed output produced. Section 8 recapitulates about the use of MAED-1 for carrying out energy and electricity planning studies, describes the several phases normally involved in this type of study and provides the user with practical hints about the most important aspects that need to be verified at each phase while executing the various MAED modules

  16. Dry needling and exercise for chronic whiplash - a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Souvlis Tina

    2009-12-01

    Full Text Available Abstract Background Chronic whiplash is a common and costly problem. Sensory hypersensitivity is a feature of chronic whiplash that is associated with poor responsiveness to physical treatments such as exercise. Modalities such as dry-needling have shown some capacity to modulate sensory hypersensitivity, suggesting that when combined with advice and exercise, such an approach may be more effective in the management of chronic whiplash. The primary aim of this project is to investigate the effectiveness of dry-needling, advice and exercise for chronic whiplash. Method/Design A double-blind randomised controlled trial will be conducted. 120 participants with chronic whiplash, grade II will be randomised to receive either 1 dry-needling, advice and exercise or 2 sham dry-needling, advice and exercise. All participants will receive an educational booklet on whiplash. Participants who are randomised to Group 1 will receive 6 treatments of combined dry-needling and exercise delivered in the first 3 weeks of the 6 week program, and 4 treatments of exercise only in the last 3 weeks of the program. Participants randomised to Group 2 will receive an identical protocol, except that a sham dry-needling technique will be used instead of dry-needling. The primary outcome measures are the Neck Disability Index (NDI and participants' perceived recovery. Outcomes will be measured at 6, 12, 24 and 52 weeks after randomization by an assessor who is blind to the group allocation of the participants. In parallel, an economic analysis will be conducted. Discussion This trial will utilise high quality trial methodologies in accordance with CONSORT guidelines. The successful completion of this trial will provide evidence of the effectiveness and cost-effectiveness of a combined treatment approach for the management of chronic whiplash. Trial registration ACTRN12609000470291

  17. Anti-Ma and anti-Ma2-associated paraneoplastic neurological syndromes.

    Science.gov (United States)

    Ortega Suero, G; Sola-Valls, N; Escudero, D; Saiz, A; Graus, F

    Analyse the clinical profile, associated tumour types, and response to treatment of paraneoplastic neurological syndromes associated with antibodies against Ma proteins. A retrospective study of patients with antibodies against Ma proteins identified in a neuroimmunology laboratory of reference. Of the 32 patients identified, 20 showed reactivity against Ma2 only (anti-Ma2 antibodies), 11 against Ma1 and Ma2 (anti-Ma antibodies), and 1 with reactivity against Ma1 only (anti-Ma1 antibodies). The most common clinical presentations were limbic encephalopathy, diencephalic dysfunction, or brainstem encephalopathy, frequently appearing as a combination of these features. Three patients had isolated cerebellar dysfunction with anti-Ma antibodies, and 2 exhibited peripheral nervous system syndrome with anti-Ma2 antibodies. Testicular tumours were the most common neoplasms (40%) in the anti-Ma2 cases. In the group associated with anti-Ma1 antibodies, the most common were lung tumours (36%), followed by testicular tumours. All idiopathic cases were reactive to Ma2. The clinical outcome was significantly better in the anti-Ma2 group. The patient with anti-Ma1 presented with limbic encephalitis and brainstem dysfunction associated with lymphoepithelioma of the bladder. Specifically determining the different reactivities of anti-Ma protein antibodies in order to differentiate between Ma1 and Ma2 antibodies is important because anti-Ma2-associated paraneoplastic syndromes have a better outcome. Lastly, this study is the first to confirm that there may be cases that react exclusively to antibodies against Ma1. Copyright © 2016 Sociedad Española de Neurología. Publicado por Elsevier España, S.L.U. All rights reserved.

  18. Choosing a control intervention for a randomised clinical trial

    Directory of Open Access Journals (Sweden)

    Djulbegovic Benjamin

    2003-04-01

    Full Text Available Abstract Background Randomised controlled clinical trials are performed to resolve uncertainty concerning comparator interventions. Appropriate acknowledgment of uncertainty enables the concurrent achievement of two goals : the acquisition of valuable scientific knowledge and an optimum treatment choice for the patient-participant. The ethical recruitment of patients requires the presence of clinical equipoise. This involves the appropriate choice of a control intervention, particularly when unapproved drugs or innovative interventions are being evaluated. Discussion We argue that the choice of a control intervention should be supported by a systematic review of the relevant literature and, where necessary, solicitation of the informed beliefs of clinical experts through formal surveys and publication of the proposed trial's protocol. Summary When clinical equipoise is present, physicians may confidently propose trial enrollment to their eligible patients as an act of therapeutic beneficence.

  19. Düşey Toplum Kuramı Yaklaşımıyla Japon Çalışma Kültürünü Anlamak

    OpenAIRE

    Aca, Zeynep

    2015-01-01

    Japon çalışma kültürünün temel felsefesini anlayabilmenin yolu, Japon toplumunun kültürel özelliklerini anlayabilmekten geçmektedir. Ancak kültürü oluşturan her bir özellik elbetteki Japon çalışma kültürünü aynı ölçüde etkilememektedir. İşte bu noktadan hareketle, bu çalışmada, Japon çalışma kültürü, Japon çalışma kültürünün temel felsefi belirleyicilerinden biri olduğunu düşündüğümüz ve Nakane tarafından Düşey Toplum Kuramı olarak adlandırılan Japon aile yapısı ekseninde ele alınmaya çalışıl...

  20. Prevention of postpartum haemorrhage with sublingual misoprostol or oxytocin: a double-blind randomised controlled trial.

    Science.gov (United States)

    Bellad, M B; Tara, D; Ganachari, M S; Mallapur, M D; Goudar, S S; Kodkany, B S; Sloan, N L; Derman, R

    2012-07-01

    Sublingual misoprostol produces a rapid peak concentration, and is more effective than oral administration. We compared the postpartum measured blood loss with 400 μg powdered sublingual misoprostol and after standard care using 10 iu intramuscular (IM) oxytocin. Double-blind randomised controlled trial. A teaching hospital: J N Medical College, Belgaum, India. A cohort of 652 consenting eligible pregnant women admitted to the labour room. Subjects were assigned to receive the study medications and placebos within 1 minute of clamping and cutting the cord by computer-generated randomisation. Chi-square and bootstrapped Student's t-tests were used to test categorical and continuous outcomes, respectively. Measured mean postpartum blood loss and haemorrhage (PPH, loss ≥ 500 ml), >10% pre- to post-partum decline in haemoglobin, and reported side effects. The mean blood loss with sublingual misoprostol was 192 ± 124 ml (n=321) and 366 ± 136 ml with oxytocin IM (n=331, P ≤ 0.001). The incidence of PPH was 3.1% with misoprostol and 9.1% with oxytocin (P=0.002). No woman lost ≥ 1000 ml of blood. We observed that 9.7% and 45.6% of women experienced a haemoglobin decline of >10% after receiving misoprostol and oxytocin, respectively (P ≤ 0.001). Side effects were significantly greater in the misoprostol group than in the oxytocin group. Unlike other studies, this trial found sublingual misoprostol more effective than intramuscular oxytocin in reducing PPH, with only transient side effects being greater in the misoprostol group. The sublingual mode and/or powdered formulation may increase the effectiveness of misoprostol, and render it superior to injectable oxytocin for the prevention of PPH. Further research is needed to confirm these results. © 2012 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2012 RCOG.

  1. Does hydrotherapy improve strength and physical function in patients with osteoarthritis—a randomised controlled trial comparing a gym based and a hydrotherapy based strengthening programme

    Science.gov (United States)

    Foley, A; Halbert, J; Hewitt, T; Crotty, M

    2003-01-01

    Objective: To compare the effects of a hydrotherapy resistance exercise programme with a gym based resistance exercise programme on strength and function in the treatment of osteoarthritis (OA). Design: Single blind, three arm, randomised controlled trial. Subjects: 105 community living participants aged 50 years and over with clinical OA of the hip or knee. Methods: Participants were randomised into one of three groups: hydrotherapy (n = 35), gym (n = 35), or control (n = 35). The two exercising groups had three exercise sessions a week for six weeks. At six weeks an independent physiotherapist unaware of the treatment allocation performed all outcome assessments (muscle strength dynamometry, six minute walk test, WOMAC OA Index, total drugs, SF-12 quality of life, Adelaide Activities Profile, and the Arthritis Self-Efficacy Scale). Results: In the gym group both left and right quadriceps significantly increased in strength compared with the control group, and right quadriceps strength was also significantly better than in the hydrotherapy group. The hydrotherapy group increased left quadriceps strength only at follow up, and this was significantly different from the control group. The hydrotherapy group was significantly different from the control group for distance walked and the physical component of the SF-12. The gym group was significantly different from the control group for walk speed and self efficacy satisfaction. Compliance rates were similar for both exercise groups, with 84% of hydrotherapy and 75% of gym sessions attended. There were no differences in drug use between groups over the study period. Conclusion: Functional gains were achieved with both exercise programmes compared with the control group. PMID:14644853

  2. Aspirin plus dipyridamole versus aspirin alone after cerebral ischaemia of arterial origin (ESPRIT): randomised controlled trial.

    Science.gov (United States)

    Halkes, P H A; van Gijn, J; Kappelle, L J; Koudstaal, P J; Algra, A

    2006-05-20

    Results of trials of aspirin and dipyridamole combined versus aspirin alone for the secondary prevention of vascular events after ischaemic stroke of presumed arterial origin are inconsistent. Our aim was to resolve this uncertainty. We did a randomised controlled trial in which we assigned patients to aspirin (30-325 mg daily) with (n=1363) or without (n=1376) dipyridamole (200 mg twice daily) within 6 months of a transient ischaemic attack or minor stroke of presumed arterial origin. Our primary outcome event was the composite of death from all vascular causes, non-fatal stroke, non-fatal myocardial infarction, or major bleeding complication, whichever happened first. Treatment was open, but auditing of outcome events was blinded. Primary analysis was by intention to treat. This study is registered as an International Standard Randomised Controlled Trial (number ISRCTN73824458) and with (NCT00161070). Mean follow-up was 3.5 years (SD 2.0). Median aspirin dose was 75 mg in both treatment groups (range 30-325); extended-release dipyridamole was used by 83% (n=1131) of patients on the combination regimen. Primary outcome events arose in 173 (13%) patients on aspirin and dipyridamole and in 216 (16%) on aspirin alone (hazard ratio 0.80, 95% CI 0.66-0.98; absolute risk reduction 1.0% per year, 95% CI 0.1-1.8). Addition of the ESPRIT data to the meta-analysis of previous trials resulted in an overall risk ratio for the composite of vascular death, stroke, or myocardial infarction of 0.82 (95% CI 0.74-0.91). Patients on aspirin and dipyridamole discontinued trial medication more often than those on aspirin alone (470 vs 184), mainly because of headache. The ESPRIT results, combined with the results of previous trials, provide sufficient evidence to prefer the combination regimen of aspirin plus dipyridamole over aspirin alone as antithrombotic therapy after cerebral ischaemia of arterial origin.

  3. Posición comercial regional de los maíces mejorados generados por el INIFAP en Veracruz

    Directory of Open Access Journals (Sweden)

    Ana Lid del Angel-Pérez

    2016-01-01

    Full Text Available Introducción. El maíz es un cereal básico en la alimentación mexicana y el más cultivado por los agricultores. Sin embargo, la demanda de maíz para consumo y de semilla mejorada (SM, ha ocasionado fuertes importaciones, pues en 2012, se importaron 9´515,000 t. Gran parte de la demanda de SM es cubierta por empresas transnacionales, y en menor medida por pequeñas empresas privadas y organismos gubernamentales como el Instituto Nacional de Investigaciones Forestales, Agrícolas y Pecuarias (INIFAP. El objetivo del trabajo fue conocer el mercado regional de SM en el estado de Veracruz, la posición comercial del INIFAP y las variables relevantes que motiva la decisión de compra. Método. En 2015 se aplicó un cuestionario a 100 productores de maíz para grano, en ocho municipios del estado de Veracruz, mediante el muestreo Respondent-Driven Sampling (RDS. El instrumento consideró preguntas abiertas y cerradas de opción múltiple, para obtener información socioeconómica y perceptual sobre el conocimiento y uso de semillas mejoradas (SM de origen INIFAP o las que acostumbran sembrar. Resultados y discusión. El 75% del mercado regional de SM, las cubre el INIFAP. El mercado lo constituyen productores en pequeña escala (3.4 ha en promedio. La motivación de siembra depende de la Recomendación de amigos o familiares (p<0.0001. El uso de SM de origen INIFAP, está asociado a las variables socioeconómicas: Cercanía del lugar de compra (0.9451** y Conoce las semillas INIFAP (0.9199**, así como con el hecho de que los productores Siembran SM (0.4320** y Prefiere sembrar SM (0.3844** cuyos coeficientes de correlación son bajos pero fortalecidos por la significancia. Las variables de opinión que favorecen el uso de SM fueron: Tiene ventajas sobre los maíces criollos (0.6162** y Planta con buena arquitectura (0.3938**. Las características perceptuales importantes para el productor al consumir el grano fueron Sabor, Nixtamalización

  4. Reporting quality of conference abstracts on randomised controlled trials in gerontology and geriatrics: a cross-sectional investigation.

    Science.gov (United States)

    Mann, Eva; Meyer, Gabriele

    2011-01-01

    Without transparent reporting of how a randomised controlled trial was designed and conducted and of the methods used, its internal validity cannot be assessed by the reader. A congress abstract is often the only source providing information about a trial. In January 2008, an extended CONSORT statement on abstract reporting was published. Its impact has yet to be evaluated. Using a slightly modified CONSORT checklist comprising 17 items, we thus investigated the reporting quality of randomised controlled trials published in the book of abstracts presented at the World Congress of Geriatrics and Gerontology in Paris in July 2009. A total of n=4,416 abstracts was screened for inclusion; n=129 met the inclusion criteria. The overall quality of the abstracts was remarkably poor. The primary outcome was mentioned in 34/129 abstracts (26%), none of the abstracts reported on the procedure of random allocation of participants or clusters, 21/129 abstracts (16%) reported some kind of blinding, and the attrition rate was mentioned in only 12/129 abstracts (9%). The majority of abstracts fulfilled two items: description of intended intervention for each group (102/129; 79%) and general interpretation of results (107/129; 83%). Trial status was reported in all abstracts. Both journal editors and committees organising congresses are requested to define the use of the CONSORT statement as a prerequisite in their guidelines for authors and to instruct reviewers to conduct compliance checks. Medical associations should finally endorse the indispensability of the CONSORT statement and publish it in their journals. Otherwise the intended benefits cannot be fully generated. Copyright © 2010. Published by Elsevier GmbH.

  5. Theory of planned behaviour variables and objective walking behaviour do not show seasonal variation in a randomised controlled trial.

    Science.gov (United States)

    Williams, Stefanie L; French, David P

    2014-02-05

    Longitudinal studies have shown that objectively measured walking behaviour is subject to seasonal variation, with people walking more in summer compared to winter. Seasonality therefore may have the potential to bias the results of randomised controlled trials if there are not adequate statistical or design controls. Despite this there are no studies that assess the impact of seasonality on walking behaviour in a randomised controlled trial, to quantify the extent of such bias. Further there have been no studies assessing how season impacts on the psychological predictors of walking behaviour to date. The aim of the present study was to assess seasonal differences in a) objective walking behaviour and b) Theory of Planned Behaviour (TPB) variables during a randomised controlled trial of an intervention to promote walking. 315 patients were recruited to a two-arm cluster randomised controlled trial of an intervention to promote walking in primary care. A series of repeated measures ANCOVAs were conducted to examine the effect of season on pedometer measures of walking behaviour and TPB measures, assessed immediately post-intervention and six months later. Hierarchical regression analyses were conducted to assess whether season moderated the prediction of intention and behaviour by TPB measures. There were no significant differences in time spent walking in spring/summer compared to autumn/winter. There was no significant seasonal variation in most TPB variables, although the belief that there will be good weather was significantly higher in spring/summer (F = 19.46, p behaviour, or moderate the effects of TPB variables on intention or behaviour. Seasonality does not influence objectively measured walking behaviour or psychological variables during a randomised controlled trial. Consequently physical activity behaviour outcomes in trials will not be biased by the season in which they are measured. Previous studies may have overestimated the extent of

  6. Situación de la producción de fríjol y maíz en concepción de pilas y Veracruz de Pejibaye, Costa Rica

    Directory of Open Access Journals (Sweden)

    Pablo Alvarez

    2001-01-01

    Full Text Available El estudio socioeconómico se llevó a cabo en la zona sur de Costa Rica, en el distrito de Pejibaye del cantón de Pérez Zeledón, mediante una encuesta a 80 productores escogidos aleatoriamente; en el mes de mayo de 1999. El 84% de los agricultores poseen tierra propia para la producción, con unidades productivas en promedio de 14,5 ha. La mayoría de los productores de granos básicos diversifican con otras actividades agropecuarias, como tiquisque, café y pastos. El nivel de diversificación se incrementó con el tamaño de las unidades productivas. La mayor parte lo diversifica con la combinación maíz y frijol. El 90% de los productores que siembran maíz, tienen este cultivo durante la época veranera (diciembre a febrero, con un área promedio de 2,5 ha y con un rendimiento promedio de 1,9 t/ha. En el caso del frijol la siembra principal se da en la época inverniz (mayo a agosto, con un área promedio de 3 ha, y un rendimiento de 0,6 t/ha. Para ambos granos, la tendencia es hacia la reducción de áreas y rendimientos. Tanto para maíz como para frijol , la mayor parte de la cosecha se destina a la venta, y en general se puede señalar que la producción de ambos granos resulta rentable en términos de la relación beneficio/costo, siendo más rentable la actividad frijolera. En los últimos años las inestabilidades climáticas han afectado los rendimientos de los granos básicos, lo cual ha llevado a los productores a incursionar en otras actividades productivas. Los productores han empezado a utilizar una serie de estrategias para contrarrestar estos efectos, tales como el uso de coberturas, y diversas prácticas culturales y agronómicas

  7. Evaluation of an online interactive Diabetes Needs Assessment Tool (DNAT versus online self-directed learning: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Kellner Thomas

    2011-06-01

    Full Text Available Abstract Background Methods for the dissemination, understanding and implementation of clinical guidelines need to be examined for their effectiveness to help doctors integrate guidelines into practice. The objective of this randomised controlled trial was to evaluate the effectiveness of an interactive online Diabetes Needs Assessment Tool (DNAT (which constructs an e-learning curriculum based on individually identified knowledge gaps, compared with self-directed e-learning of diabetes guidelines. Methods Health professionals were randomised to a 4-month learning period and either given access to diabetes learning modules alone (control group or DNAT plus learning modules (intervention group. Participants completed knowledge tests before and after learning (primary outcome, and surveys to assess the acceptability of the learning and changes to clinical practice (secondary outcomes. Results Sixty four percent (677/1054 of participants completed both knowledge tests. The proportion of nurses (5.4% was too small for meaningful analysis so they were excluded. For the 650 doctors completing both tests, mean (SD knowledge scores increased from 47.4% (12.6 to 66.8% (11.5 [intervention group (n = 321, 64%] and 47.3% (12.9 to 67.8% (10.8 [control group (n = 329, 66%], (ANCOVA p = 0.186. Both groups were satisfied with the usability and usefulness of the learning materials. Seventy seven percent (218/284 of the intervention group reported combining the DNAT with the recommended reading materials was "very useful"/"useful". The majority in both groups (184/287, 64.1% intervention group and 206/299, 68.9% control group [95% CI for the difference (-2.8 to 12.4] reported integrating the learning into their clinical practice. Conclusions Both groups experienced a similar and significant improvement in knowledge. The learning materials were acceptable and participants incorporated the acquired knowledge into practice. Trial registration ISRCTN: ISRCTN67215088

  8. Impact of an educational DVD on anxiety and glycaemic control in women diagnosed with gestational diabetes mellitus (GDM): A randomised controlled trial.

    Science.gov (United States)

    Draffin, Claire R; Alderdice, Fiona A; McCance, David R; Maresh, Michael; Harper, Roy; Patterson, Christopher C; Bernatavicius, Giovanna; Brennan, Sarah F; Gough, Aisling; McSorley, Oonagh; Holmes, Valerie A

    2017-04-01

    The diagnosis of gestational diabetes mellitus (GDM) during pregnancy can lead to anxiety. This study evaluated the impact of an innovative patient-centred educational DVD on anxiety and glycaemic control in women newly diagnosed with GDM. 150 multi-ethnic women, aged 19-44years, from three UK hospitals were randomised to either usual care plus DVD (DVD group, n=77) or usual care alone (control group, n=73) at GDM diagnosis. Primary outcomes were anxiety (State-Trait Anxiety Inventory) and mean 1-h postprandial capillary self-monitored blood glucose for all meals, on day prior to follow-up. No significant difference between the DVD and control group were reported, for anxiety (37.7±11.7 vs 36.2±10.9; mean difference after adjustment for covariates (95% CI) 2.5 (-0.8, 5.9) or for mean 1-h postprandial glucose for all meals (6.9±0.9 vs 7.0±1.2mmol/L; -0.2 (-0.5, 0.2). However, the DVD group had significantly lower postprandial breakfast glucose compared to the control group (6.8±1.2 vs 7.4±1.9mmol/L; -0.5 (-1.1, -gestational diabetes. Copyright © 2017 Elsevier B.V. All rights reserved.

  9. A randomised, controlled trial of circumpatellar electrocautery in total knee replacement without patellar resurfacing

    NARCIS (Netherlands)

    Jonbergen, H.P. van; Scholtes, V.A.; Kampen, A. van; Poolman, R.W.

    2011-01-01

    The efficacy of circumpatellar electrocautery in reducing the incidence of post-operative anterior knee pain is unknown. We conducted a single-centre, outcome-assessor and patient-blinded, parallel-group, randomised, controlled trial to compare circumpatellar electrocautery with no electrocautery in

  10. Variabilidad y evolución del rendimiento en cultivares argentinos de maíz duro

    OpenAIRE

    Loffler, C. M.; Salaberry, M. T.; Stinziani, J.; Favoretti, C. H.

    1986-01-01

    p.125-132 Se ilustra sobre el uso de una metodología para el análisis e interpretación de datos de redes territoriales de ensayos de cultivares. Se evaluaron datos de veinticinco cultivares de maíz (Zea mays l.) duro, en seis ambientes de la subregión ecológica IX y de todos los cultivares de ensayos conducidos en dos localidades de cada una de las subregiones IX y VI entre 1972 y 1985. Se determinó variabilidad genética y relaciones entre caracteres para la subregión IX y progreso genétic...

  11. Efficacy of rasagiline in patients with the parkinsonian variant of multiple system atrophy: a randomised, placebo-controlled trial.

    Science.gov (United States)

    Poewe, Werner; Seppi, Klaus; Fitzer-Attas, Cheryl J; Wenning, Gregor K; Gilman, Sid; Low, Phillip A; Giladi, Nir; Barone, Paolo; Sampaio, Cristina; Eyal, Eli; Rascol, Olivier

    2015-02-01

    Multiple system atrophy is a complex neurodegenerative disorder for which no effective treatment exists. We aimed to assess the effect of rasagiline on symptoms and progression of the parkinsonian variant of multiple system atrophy. We did this randomised, double-blind, placebo-controlled trial between Dec 15, 2009, and Oct 20, 2011, at 40 academic sites specialised in the care of patients with multiple systemic atrophy across 12 countries. Eligible participants aged 30 years or older with possible or probable parkinsonian variant multiple system atrophy were randomly assigned (1:1), via computer-generated block randomisation (block size of four), to receive either rasagiline 1 mg per day or placebo. Randomisation was stratified by study centre. The investigators, study funder, and personnel involved in patient assessment, monitoring, analysis and data management were masked to group assignment. The primary endpoint was change from baseline to study end in total Unified Multiple System Atrophy Rating Scale (UMSARS) score (parts I and II). Analysis was by modified intention to treat. The trial is registered with ClinicalTrials.gov, number NCT00977665. We randomly assigned 174 participants to the rasagiline group (n=84) or the placebo group (n=90); 21 (25%) patients in the rasagiline group and 15 (17%) in the placebo group withdrew from the study early. At week 48, patients in the rasagiline group had progressed by an adjusted mean of 7·2 (SE 1·2) total UMSARS units versus 7·8 (1·1) units in those in the placebo group. This treatment difference of -0·60 (95% CI -3·68 to 2·47; p=0·70) was not significant. 68 (81%) patients in the rasagiline group and 67 (74%) patients in the placebo group reported adverse events, and we recorded serious adverse events in 29 (35%) versus 23 (26%) patients. The most common adverse events in the rasagiline group were dizziness (n=10 [12%]), peripheral oedema (n=9 [11%]), urinary tract infections (n=9 [11%]), and orthostatic

  12. Binocular treatment of amblyopia using videogames (BRAVO): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Guo, Cindy X; Babu, Raiju J; Black, Joanna M; Bobier, William R; Lam, Carly S Y; Dai, Shuan; Gao, Tina Y; Hess, Robert F; Jenkins, Michelle; Jiang, Yannan; Kowal, Lionel; Parag, Varsha; South, Jayshree; Staffieri, Sandra Elfride; Walker, Natalie; Wadham, Angela; Thompson, Benjamin

    2016-10-18

    Amblyopia is a common neurodevelopmental disorder of vision that is characterised by visual impairment in one eye and compromised binocular visual function. Existing evidence-based treatments for children include patching the nonamblyopic eye to encourage use of the amblyopic eye. Currently there are no widely accepted treatments available for adults with amblyopia. The aim of this trial is to assess the efficacy of a new binocular, videogame-based treatment for amblyopia in older children and adults. We hypothesise that binocular treatment will significantly improve amblyopic eye visual acuity relative to placebo treatment. The BRAVO study is a double-blind, randomised, placebo-controlled multicentre trial to assess the effectiveness of a novel videogame-based binocular treatment for amblyopia. One hundred and eight participants aged 7 years or older with anisometropic and/or strabismic amblyopia (defined as ≥0.2 LogMAR interocular visual acuity difference, ≥0.3 LogMAR amblyopic eye visual acuity and no ocular disease) will be recruited via ophthalmologists, optometrists, clinical record searches and public advertisements at five sites in New Zealand, Canada, Hong Kong and Australia. Eligible participants will be randomised by computer in a 1:1 ratio, with stratification by age group: 7-12, 13-17 and 18 years and older. Participants will be randomised to receive 6 weeks of active or placebo home-based binocular treatment. Treatment will be in the form of a modified interactive falling-blocks game, implemented on a 5th generation iPod touch device viewed through red/green anaglyphic glasses. Participants and those assessing outcomes will be blinded to group assignment. The primary outcome is the change in best-corrected distance visual acuity in the amblyopic eye from baseline to 6 weeks post randomisation. Secondary outcomes include distance and near visual acuity, stereopsis, interocular suppression, angle of strabismus (where applicable) measured at

  13. Changing cluster composition in cluster randomised controlled trials: design and analysis considerations

    Science.gov (United States)

    2014-01-01

    Background There are many methodological challenges in the conduct and analysis of cluster randomised controlled trials, but one that has received little attention is that of post-randomisation changes to cluster composition. To illustrate this, we focus on the issue of cluster merging, considering the impact on the design, analysis and interpretation of trial outcomes. Methods We explored the effects of merging clusters on study power using standard methods of power calculation. We assessed the potential impacts on study findings of both homogeneous cluster merges (involving clusters randomised to the same arm of a trial) and heterogeneous merges (involving clusters randomised to different arms of a trial) by simulation. To determine the impact on bias and precision of treatment effect estimates, we applied standard methods of analysis to different populations under analysis. Results Cluster merging produced a systematic reduction in study power. This effect depended on the number of merges and was most pronounced when variability in cluster size was at its greatest. Simulations demonstrate that the impact on analysis was minimal when cluster merges were homogeneous, with impact on study power being balanced by a change in observed intracluster correlation coefficient (ICC). We found a decrease in study power when cluster merges were heterogeneous, and the estimate of treatment effect was attenuated. Conclusions Examples of cluster merges found in previously published reports of cluster randomised trials were typically homogeneous rather than heterogeneous. Simulations demonstrated that trial findings in such cases would be unbiased. However, simulations also showed that any heterogeneous cluster merges would introduce bias that would be hard to quantify, as well as having negative impacts on the precision of estimates obtained. Further methodological development is warranted to better determine how to analyse such trials appropriately. Interim recommendations

  14. Reducing Postpartum Weight Retention and Improving Breastfeeding Outcomes in Overweight Women: A Pilot Randomised Controlled Trial

    Directory of Open Access Journals (Sweden)

    Julia Martin

    2015-02-01

    Full Text Available Overweight and obesity is prevalent among women of reproductive age (42% BMI > 25 kg/m2 and parity is associated with risk of weight gain. Weight gain greater than that recommended by the Institute of Medicine (IOM is also associated with lower rates of breastfeeding initiation and duration in women. The aim of this pilot randomised controlled trial is to examine the feasibility of recruiting and maintaining a cohort of pregnant women with the view of reducing postpartum weight retention and improving breastfeeding outcomes. Women (BMI of 25–35 kg/m2 (n = 36 were recruited from the John Hunter Hospital antenatal clinic in New South Wales, Australia. Participants were stratified by BMI and randomised to one of three groups with follow-up to six months postpartum. Women received a dietary intervention with or without breastfeeding support from a lactation consultant, or were assigned to a wait-list control group where the dietary intervention was issued at three months postpartum. Feasibility and acceptability was assessed by participation rates and questionnaire. Analysis of variance and covariance was conducted to determine any differences between groups. Sixty-nine per cent of the participants were still enrolled at six months postpartum. This pilot demonstrated some difficulties in recruiting women from antenatal clinics and retaining them in the trial. Although underpowered; the results on weight; biomarkers and breastfeeding outcomes indicated improved metabolic health.

  15. Changes in body weight and food choice in those attempting smoking cessation: a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Leslie Wilma S

    2012-05-01

    Full Text Available Abstract Background Fear of weight gain is a barrier to smoking cessation and significant cause of relapse for many people. The provision of nutritional advice as part of a smoking cessation programme may assist some in smoking cessation and perhaps limit weight gain. The aim of this study was to determine the effect of a structured programme of dietary advice on weight change and food choice, in adults attempting smoking cessation. Methods Cluster randomised controlled design. Classes randomised to intervention commenced a 24-week intervention, focussed on improving food choice and minimising weight gain. Classes randomised to control received “usual care”. Results Twenty-seven classes in Greater Glasgow were randomised between January and August 2008. Analysis, including those who continued to smoke, showed that actual weight gain and percentage weight gain was similar in both groups. Examination of data for those successful at giving up smoking showed greater mean weight gain in intervention subjects (3.9 (SD 3.1 vs. 2.7 (SD 3.7 kg. Between group differences were not significant (p = 0.23, 95% CI −0.9 to 3.5. In comparison to baseline improved consumption of fruit and vegetables and breakfast cereal were reported in the intervention group. A higher percentage of control participants continued smoking (74% vs. 66%. Conclusions The intervention was not successful at minimising weight gain in comparison to control but was successful in facilitating some sustained improvements in the dietary habits of intervention participants. Improved quit rates in the intervention group suggest that continued contact with advisors may have reduced anxieties regarding weight gain and encouraged cessation despite weight gain. Research should continue in this area as evidence suggests that the negative effects of obesity could outweigh the health benefits achieved through reductions in smoking prevalence. Trial registration Current Controlled Trials

  16. Rethinking clinical trials of transcranial direct current stimulation: participant and assessor blinding is inadequate at intensities of 2mA.

    Directory of Open Access Journals (Sweden)

    Neil E O'Connell

    Full Text Available BACKGROUND: Many double-blind clinical trials of transcranial direct current stimulation (tDCS use stimulus intensities of 2 mA despite the fact that blinding has not been formally validated under these conditions. The aim of this study was to test the assumption that sham 2 mA tDCS achieves effective blinding. METHODS: A randomised double blind crossover trial. 100 tDCS-naïve healthy volunteers were incorrectly advised that they there were taking part in a trial of tDCS on word memory. Participants attended for two separate sessions. In each session, they completed a word memory task, then received active or sham tDCS (order randomised at 2 mA stimulation intensity for 20 minutes and then repeated the word memory task. They then judged whether they believed they had received active stimulation and rated their confidence in that judgement. The blinded assessor noted when red marks were observed at the electrode sites post-stimulation. RESULTS: tDCS at 2 mA was not effectively blinded. That is, participants correctly judged the stimulation condition greater than would be expected to by chance at both the first session (kappa level of agreement (κ 0.28, 95% confidence interval (CI 0.09 to 0.47 p=0.005 and the second session (κ=0.77, 95%CI 0.64 to 0.90, p=<0.001 indicating inadequate participant blinding. Redness at the reference electrode site was noticeable following active stimulation more than sham stimulation (session one, κ=0.512, 95%CI 0.363 to 0.66, p<0.001; session two, κ=0.677, 95%CI 0.534 to 0.82 indicating inadequate assessor blinding. CONCLUSIONS: Our results suggest that blinding in studies using tDCS at intensities of 2 mA is inadequate. Positive results from such studies should be interpreted with caution.

  17. Cognitive rehabiliation for Parkinson's disease demantia: a study protocol for a pilot randomised controlled trial.

    Science.gov (United States)

    Hindle, John V; Watermeyer, Tamlyn J; Roberts, Julie; Martyr, Anthony; Lloyd-Williams, Huw; Brand, Andrew; Gutting, Petra; Hoare, Zoe; Edwards, Rhiannon Tudor; Clare, Linda

    2016-03-22

    There is growing interest in developing non-pharmacological treatments to address the cognitive deficits apparent in Parkinson's disease dementia and dementia with Lewy bodies. Cognitive rehabilitation is a goal-oriented behavioural intervention which focuses on improving everyday functioning through management of cognitive difficulties; it has been shown to be effective in Alzheimer's disease. To date, no studies have assessed its potential efficacy for addressing the impact of cognitive impairment in people with Parkinson's disease or dementia with Lewy bodies. Participants (n = 45) will be recruited from movement disorders, care for the elderly and memory clinics. Inclusion criteria include: a diagnosis of Parkinson's disease, Parkinson's disease dementia or dementia with Lewy bodies according to consensus criteria and an Addenbrooke's Cognitive Examination - III score of ≤ 82. Exclusion criteria include: a diagnosis of any other significant neurological condition; major psychiatric disorder, including depression, which is not related to the patient's Parkinson's disease and unstable medication use for their physical or cognitive symptoms. A single-blind pilot randomised controlled trial, with concurrent economic evaluation, will compare the relative efficacy of cognitive rehabilitation with that of two control conditions. Following a goal-setting interview, the participants will be randomised to one of the three study arms: cognitive rehabilitation (eight weekly sessions), relaxation therapy (eight weekly sessions) or treatment as usual. Randomisation and treatment group allocation will be carried out by a clinical trials unit using a dynamic adaptive sequential randomisation algorithm. The primary outcomes are patients' perceived goal attainment at a 2-months post-intervention assessment and a 6-months follow-up. Secondary outcomes include patients' objective cognitive performance (on tests of memory and executive function) and satisfaction with goal

  18. Twelve month follow-up on a randomised controlled trial of relaxation training for post-stroke anxiety.

    Science.gov (United States)

    Golding, Katherine; Fife-Schaw, Chris; Kneebone, Ian

    2017-09-01

    To follow up participants in a randomised controlled trial of relaxation training for anxiety after stroke at 12 months. Twelve month follow-up to a randomised controlled trial, in which the control group also received treatment. Community. Fifteen of twenty one original participants with post-stroke anxiety participated in a one year follow-up study. A self-help autogenic relaxation CD listened to five times a week for one month, immediately in the intervention group and after three months in the control group. Hospital Anxiety and Depression Scale-Anxiety subscale and the Telephone Interview of Cognitive Status for inclusion. Hospital Anxiety and Depression Scale-Anxiety subscale for outcome. All measures were administered by phone. Anxiety ratings reduced significantly between pre and post-intervention, and between pre-intervention and one year follow-up ( χ 2 (2) = 22.29, p autogenic relaxation CD appear to be maintained after one year.

  19. Anti-Ma2 antibody related paraneoplastic limbic/brain stem encephalitis associated with breast cancer expressing Ma1, Ma2, and Ma3 mRNAs.

    Science.gov (United States)

    Sahashi, K; Sakai, K; Mano, K; Hirose, G

    2003-09-01

    A 69 year old woman presented with cognitive impairment and supranuclear gaze palsy caused by paraneoplastic limbic/brain stem encephalitis associated with atypical medullary breast carcinoma. The cerebrospinal fluid from the patient harboured an anti-neuronal cell antibody against Ma2 antigen, but not against Ma1 or Ma3 antigen. Despite the antibody being restricted to the Ma2 antigen, the patient's cancer tissue expressed Ma1, Ma2, and Ma3 mRNAs. These results, and the expression of Ma2 mRNA in an atypical medullar breast carcinoma in another patient without paraneoplastic encephalitis, indicate that the induction of anti-Ma2 antibody depends on host immunoreponsiveness and not on the presence of the antigen itself in the cancer.

  20. 'Putting Life in Years' (PLINY) telephone friendship groups research study: pilot randomised controlled trial.

    Science.gov (United States)

    Mountain, Gail A; Hind, Daniel; Gossage-Worrall, Rebecca; Walters, Stephen J; Duncan, Rosie; Newbould, Louise; Rex, Saleema; Jones, Carys; Bowling, Ann; Cattan, Mima; Cairns, Angela; Cooper, Cindy; Edwards, Rhiannon Tudor; Goyder, Elizabeth C

    2014-04-24

    Loneliness in older people is associated with poor health-related quality of life (HRQoL). We undertook a parallel-group randomised controlled trial to evaluate the effectiveness and cost-effectiveness of telephone befriending for the maintenance of HRQoL in older people. An internal pilot tested the feasibility of the trial and intervention. Participants aged >74 years, with good cognitive function, living independently in one UK city were recruited through general practices and other sources, then randomised to: (1) 6 weeks of short one-to-one telephone calls, followed by 12 weeks of group telephone calls with up to six participants, led by a trained volunteer facilitator; or (2) a control group. The main trial required the recruitment of 248 participants in a 1-year accrual window, of whom 124 were to receive telephone befriending. The pilot specified three success criteria which had to be met in order to progress the main trial to completion: recruitment of 68 participants in 95 days; retention of 80% participants at 6 months; successful delivery of telephone befriending by local franchise of national charity. The primary clinical outcome was the Short Form (36) Health Instrument (SF-36) Mental Health (MH) dimension score collected by telephone 6 months following randomisation. We informed 9,579 older people about the study. Seventy consenting participants were randomised to the pilot in 95 days, with 56 (80%) providing valid primary outcome data (26 intervention, 30 control). Twenty-four participants randomly allocated to the research arm actually received telephone befriending due to poor recruitment and retention of volunteer facilitators. The trial was closed early as a result. The mean 6-month SF-36 MH scores were 78 (SD 18) and 71 (SD 21) for the intervention and control groups, respectively (mean difference, 7; 95% CI, -3 to 16). Recruitment and retention of participants to a definitive trial with a recruitment window of 1 year is feasible. For

  1. Draining after breast reduction: a randomised controlled inter-patient study

    NARCIS (Netherlands)

    Corion, Leonard U. M.; Smeulders, Mark J. C.; van Zuijlen, Paul P. M.; van der Horst, Chantal M. A. M.

    2009-01-01

    One hundred and seven bilateral breast reductions were prospectively randomised during surgery to receive or not receive wound drains. Fifty-five patients were randomised to have a drain and 52 to not have a drain. There was no statistical difference in the number of complications between the

  2. A randomised controlled trial to improve general practitioners' services in cancer rehabilitation: Effects on general practitioners' proactivity and on patients' participation in rehabilitation activities

    DEFF Research Database (Denmark)

    Bergholdt, SH; Søndergaard, J; Larsen, PV

    2013-01-01

    by their GP reported by the patients and GPs, respectively, and patients' participation in rehabilitation activities. Methods. Cluster randomised controlled trial. All general practices in Denmark were randomised to an intervention group or to a control group (usual procedures). Patients were subsequently...

  3. Participatory ergonomics to reduce exposure to psychosocial and physical risk factors for low back pain and neck pain: results of a cluster randomised controlled trial.

    Science.gov (United States)

    Driessen, Maurice T; Proper, Karin I; Anema, Johannes R; Knol, Dirk L; Bongers, Paulien M; van der Beek, Allard J

    2011-09-01

    This study investigated the effectiveness of the Stay@Work participatory ergonomics programme to reduce workers' exposure to psychosocial and physical risk factors. 37 departments (n=3047 workers) from four Dutch companies participated in this cluster randomised controlled trial; 19 (n=1472 workers) were randomised to an intervention group (participatory ergonomics) and 18 (n=1575 workers) to a control group (no participatory ergonomics). During a 6 h meeting guided by an ergonomist, working groups devised ergonomic measures to reduce psychosocial and physical workload and implemented them within 3months in their departments. Data on psychosocial and physical risk factors for low back pain and neck pain were collected at baseline and after 6 months. Psychosocial risk factors were measured using the Job Content Questionnaire and physical risk factors using the Dutch Musculoskeletal Questionnaire. Intervention effects were studied using multilevel analysis. Intervention group workers significantly increased on decision latitude (0.29 points; 95% CI 0.07 to 0.52) and decision authority (0.16 points; 95% CI 0.04 to 0.28) compared to control workers. However, exposure to awkward trunk working postures significantly increased in the intervention group (OR 1.86; 95% CI 1.15 to 3.01) compared to the control group. No significant differences between the intervention and control group were found for the remaining risk factors. After 6months, loss to follow-up was 35% in the intervention group and 29% in the control group. Participatory ergonomics was not effective in reducing exposure to psychosocial and physical risk factors for low back pain and neck pain among a large group of workers. ISRCTN27472278.

  4. A randomised controlled trial using mobile advertising to promote safer sex and sun safety to young people.

    Science.gov (United States)

    Gold, J; Aitken, C K; Dixon, H G; Lim, M S C; Gouillou, M; Spelman, T; Wakefield, M; Hellard, M E

    2011-10-01

    Mobile phone text messages (SMS) are a promising method of health promotion, but a simple and low cost way to obtain phone numbers is required to reach a wide population. We conducted a randomised controlled trial with simultaneous brief interventions to (i) evaluate effectiveness of messages related to safer sex and sun safety and (ii) pilot the use of mobile advertising for health promotion. Mobile advertising subscribers aged 16-29 years residing in Victoria, Australia (n = 7606) were randomised to the 'sex' or 'sun' group and received eight messages during the 2008-2009 summer period. Changes in sex- and sun-related knowledge and behaviour were measured by questionnaires completed on mobile phones. At follow-up, the sex group had significantly higher sexual health knowledge and fewer sexual partners than the sun group. The sun group had no change in hat-wearing frequency compared with a significant decline in hat-wearing frequency in the sex group. This is the first study of mobile advertising for health promotion, which can successfully reach most young people. Challenges experienced with project implementation and evaluation should be considered as new technological approaches to health promotion continue to be expanded.

  5. Efectividad de métodos de control de malezas en la producción de forraje del pasto Pangola (Digitaria decumbens Stent.

    Directory of Open Access Journals (Sweden)

    Valent\\u00EDn Alberto Esqueda-Esquivel

    2007-01-01

    Full Text Available Efectividad de métodos de con trol de ma le zas en la producción de forraje del pasto Pangola (Digitaria decumbens Stent. En el periodo de agosto de 1998 a agosto de 1999 se condujo un experimento en Emilio Carranza, municipio de Ve ga de Alatorre, Ve racruz, México, con el objeto de determinar el efec to de tra ta mien tos de con trol quí mi co y ma nual de ma le zas en la pro duc ción de fo rraje de zacate Pangola y en la den si dad de po bla ción de ma le zas presentes al inicio del siguiente ciclo de lluvias. Se utilizó el diseño experimental de blo ques completos al azar con cua tro re pe ti cio nes. Los tra tamien tos evaluados fueron: 1. Mezcla for mulada de picloram + 2,4-D (64 + 240 g/100 l agua 2. Mez cla for mu la da de pi cloram + flu ro xi pir (40 + 40 g/100 l agua 3. Con trol ma nual mediante chapeo con machete y 4. Testigo enhierbado. Las parcelas experimentales tuvieron 30 m de longitud y 10 m de anchura. Los tra ta mien tos 1, 2 y 3 se apli ca ron el 17 de agos to de 1998, cuan do la zar za de lo ma (Mimosa albida, que fue la es pe cie de ma le za do mi nan te te nía en tre 40 y 60 cm de al tu ra y la cobertura promedio de malezas del lote experimental, era de 57,9%. Se eva luó la co ber tu ra de ma le zas y pas to y el control de ma le zas a los 29, 60, 80, 114 y 154 días des pués de la aplicación de los tratamientos (DDA. También se determinó la producción de forraje de za ca te Pan go la a los 45, 80, 143 y 178 DDA. Con pi clo ram + flu ro xi pir y pi clo ram + 2,4-D, se controló más eficientemente a M. albida y el com ple jo de ma le zas her bá ceas que con el cha peo y se ob tu vo una produc ción significativamente mayor de ma teria seca de pas to. Ambos tratamientos herbicidas presentaron menor densidad de po bla ción de ma le zas en el si guien te ci clo de llu vias que el tratamiento con chapeo.

  6. Aplicación de inóculos líquidos de microorganismos nativos en el suelo: efecto en el crecimiento de plántulas de maíz

    Directory of Open Access Journals (Sweden)

    Saúl Mendoza Sánchez

    2017-04-01

    Full Text Available La liberación de nutrientes provenientes de la descomposición de residuos vegetales en el suelo es importante para obtener una adecuada nutrición de cultivos sobretodo en sistemas agroforestales. Algunos autores han señalado la posibilidad de utilizar inóculos microbianos para acelerar tanto la descomposición de dichos residuos como el crecimiento de los cultivos. El objetivo de este trabajo fue evaluar la respuesta de plantas de maíz (Zea mays a la aplicación de caldos nutritivos microbianos sobre residuos de Erytrhina americana en el suelo. Se condujo un experimento en condiciones semicontroladas en invernadero. El maíz se sembró en macetas llenas con suelo tratado con caldos nutritivos microbianos de seis diferentes localidades, los indicadores de la respuesta de las plantas de maíz fueron área foliar, biomasa y altura de la planta; se midió además producción de CO2 del suelo contenido en las macetas. Los resultados mostraron que área foliar, biomasa y producción de CO2 respondieron positivamente a la aplicación del follaje de Erytrhina americana. Sólo algunos caldos nutritivos microbianos afectaron significativamente las variables de respuesta evaluadas, y ninguno resultó superior a los resultados obtenidos con el tratamiento control que tenía suelo más residuos sin microorganismos. Los resultados señalan la necesidad de mayor investigación sobre la composición, dosis y frecuencia de aplicación de los inóculos y muestran la utilidad del método de comparación para encontrar diferencias en el impacto de los mismos.

  7. Pelvic floor muscle training for secondary prevention of pelvic organ prolapse (PREVPROL): a multicentre randomised controlled trial.

    Science.gov (United States)

    Hagen, Suzanne; Glazener, Cathryn; McClurg, Doreen; Macarthur, Christine; Elders, Andrew; Herbison, Peter; Wilson, Don; Toozs-Hobson, Philip; Hemming, Christine; Hay-Smith, Jean; Collins, Marissa; Dickson, Sylvia; Logan, Janet

    2017-01-28

    Pelvic floor muscle training can reduce prolapse severity and symptoms in women seeking treatment. We aimed to assess whether this intervention could also be effective in secondary prevention of prolapse and the need for future treatment. We did this multicentre, parallel-group, randomised controlled trial at three centres in New Zealand and the UK. Women from a longitudinal study of pelvic floor function after childbirth were potentially eligible for inclusion. Women of any age who had stage 1-3 prolapse, but had not sought treatment, were randomly assigned (1:1), via remote computer allocation, to receive either one-to-one pelvic floor muscle training (five physiotherapy appointments over 16 weeks, and annual review) plus Pilates-based pelvic floor muscle training classes and a DVD for home use (intervention group), or a prolapse lifestyle advice leaflet (control group). Randomisation was minimised by centre, parity (three or less vs more than three deliveries), prolapse stage (above the hymen vs at or beyond the hymen), and delivery method (any vaginal vs all caesarean sections). Women and intervention physiotherapists could not be masked to group allocation, but allocation was masked from data entry researchers and from the trial statistician until after database lock. The primary outcome was self-reported prolapse symptoms (Pelvic Organ Prolapse Symptom Score [POP-SS]) at 2 years. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01171846. Between Dec 21, 2008, and Feb 24, 2010, in New Zealand, and Oct 27, 2010, and Sept 5, 2011, in the UK, we randomly assigned 414 women to the intervention group (n=207) or the control group (n=207). One participant in each group was excluded after randomisation, leaving 412 women for analysis. At baseline, 399 (97%) women had prolapse above or at the level of the hymen. The mean POP-SS score at 2 years was 3·2 (SD 3·4) in the intervention group versus 4·2 (SD 4·4) in the

  8. Targeted full energy and protein delivery in critically ill patients: a study protocol for a pilot randomised control trial (FEED Trial

    Directory of Open Access Journals (Sweden)

    Kate Fetterplace

    2018-02-01

    Full Text Available Abstract Background Current guidelines for the provision of protein for critically ill patients are based on incomplete evidence, due to limited data from randomised controlled trials. The present pilot randomised controlled trial is part of a program of work to expand knowledge about the clinical effects of protein delivery to critically ill patients. The primary aim of this pilot study is to determine whether an enteral feeding protocol using a volume target, with additional protein supplementation, delivers a greater amount of protein and energy to mechanically ventilated critically ill patients than a standard nutrition protocol. The secondary aims are to evaluate the potential effects of this feeding strategy on muscle mass and other patient-centred outcomes. Methods This prospective, single-centred, pilot, randomised control trial will include 60 participants who are mechanically ventilated and can be enterally fed. Following informed consent, the participants receiving enteral nutrition in the intensive care unit (ICU will be allocated using a randomisation algorithm in a 1:1 ratio to the intervention (high-protein daily volume-based feeding protocol, providing 25 kcal/kg and 1.5 g/kg protein or standard care (hourly rate-based feeding protocol providing 25 kcal/kg and 1 g/kg protein. The co-primary outcomes are the average daily protein and energy delivered to the end of day 15 following randomisation. The secondary outcomes include change in quadriceps muscle layer thickness (QMLT from baseline (prior to randomisation to ICU discharge and other nutritional and patient-centred outcomes. Discussion This trial aims to examine whether a volume-based feeding protocol with supplemental protein increases protein and energy delivery. The potential effect of such increases on muscle mass loss will be explored. These outcomes will assist in formulating larger randomised control trials to assess mortality and morbidity. Trial registration

  9. Efficacy of a microencapsulated iron pyrophosphate-fortified fruit juice: a randomised, double-blind, placebo-controlled study in Spanish iron-deficient women.

    Science.gov (United States)

    Blanco-Rojo, Ruth; Pérez-Granados, Ana M; Toxqui, Laura; González-Vizcayno, Carmen; Delgado, Marco A; Vaquero, M Pilar

    2011-06-01

    Fe-deficiency anaemia is a worldwide health problem. We studied the influence of consuming an Fe-fortified fruit juice on Fe status in menstruating women. A randomised, double-blind, placebo-controlled study of 16 weeks of duration was performed. Subjects were randomised into two groups: the P group (n 58) or the F group (n 64), and consumed, as a supplement to their usual diet, 500 ml/d of a placebo fruit juice or an Fe-fortified fruit juice, respectively. The Fe-fortified fruit juice, containing microencapsulated iron pyrophosphate, provided 18 mg Fe/d (100 % of the RDA). At baseline and monthly, dietary intake, body weight and Fe parameters were determined: total erythrocytes, haematocrit, mean corpuscular volume (MCV), red blood cell distribution width (RDW), Hb, serum Fe, serum ferritin, serum transferrin, transferrin saturation, soluble transferrin receptor (sTfR) and zinc protoporphyrin (ZnPP). The fruit juice consumption involved increased intake of carbohydrates and vitamin C, and increased BMI within normal limits. Ferritin was higher in the F group after week 4 (P juice improves Fe status and may be used to prevent Fe-deficiency anaemia.

  10. Induction of labour versus expectant monitoring for gestational hypertension or mild pre-eclampsia after 36 weeks' gestation (HYPITAT): a multicentre, open-label randomised controlled trial.

    Science.gov (United States)

    Koopmans, Corine M; Bijlenga, Denise; Groen, Henk; Vijgen, Sylvia M C; Aarnoudse, Jan G; Bekedam, Dick J; van den Berg, Paul P; de Boer, Karin; Burggraaff, Jan M; Bloemenkamp, Kitty W M; Drogtrop, Addy P; Franx, Arie; de Groot, Christianne J M; Huisjes, Anjoke J M; Kwee, Anneke; van Loon, Aren J; Lub, Annemiek; Papatsonis, Dimitri N M; van der Post, Joris A M; Roumen, Frans J M E; Scheepers, Hubertina C J; Willekes, Christine; Mol, Ben W J; van Pampus, Maria G

    2009-09-19

    Robust evidence to direct management of pregnant women with mild hypertensive disease at term is scarce. We investigated whether induction of labour in women with a singleton pregnancy complicated by gestational hypertension or mild pre-eclampsia reduces severe maternal morbidity. We undertook a multicentre, parallel, open-label randomised controlled trial in six academic and 32 non-academic hospitals in the Netherlands between October, 2005, and March, 2008. We enrolled patients with a singleton pregnancy at 36-41 weeks' gestation, and who had gestational hypertension or mild pre-eclampsia. Participants were randomly allocated in a 1:1 ratio by block randomisation with a web-based application system to receive either induction of labour or expectant monitoring. Masking of intervention allocation was not possible. The primary outcome was a composite measure of poor maternal outcome--maternal mortality, maternal morbidity (eclampsia, HELLP syndrome, pulmonary oedema, thromboembolic disease, and placental abruption), progression to severe hypertension or proteinuria, and major post-partum haemorrhage (>1000 mL blood loss). Analysis was by intention to treat and treatment effect is presented as relative risk. This study is registered, number ISRCTN08132825. 756 patients were allocated to receive induction of labour (n=377 patients) or expectant monitoring (n=379). 397 patients refused randomisation but authorised use of their medical records. Of women who were randomised, 117 (31%) allocated to induction of labour developed poor maternal outcome compared with 166 (44%) allocated to expectant monitoring (relative risk 0.71, 95% CI 0.59-0.86, phypertensive disease beyond 37 weeks' gestation. ZonMw.

  11. Children, parents, and pets exercising together (CPET) randomised controlled trial: study rationale, design, and methods.

    Science.gov (United States)

    Yam, Philippa S; Morrison, Ryan; Penpraze, Viki; Westgarth, Carri; Ward, Dianne S; Mutrie, Nanette; Hutchison, Pippa; Young, David; Reilly, John J

    2012-03-19

    Objectively measured physical activity is low in British children, and declines as childhood progresses. Observational studies suggest that dog-walking might be a useful approach to physical activity promotion in children and adults, but there are no published public health interventions based on dog-walking with children. The Children, Parents, and Pets Exercising Together Study aims to develop and evaluate a theory driven, generalisable, family-based, dog walking intervention for 9-11 year olds. The Children, Parents, and Pets Exercising Together Study is an exploratory, assessor-blinded, randomised controlled trial as defined in the UK MRC Framework on the development and evaluation of complex interventions in public health. The trial will follow CONSORT guidance. Approximately 40 dog-owning families will be allocated randomly in a ratio of 1.5:1 to receive a simple behavioural intervention lasting for 10 weeks or to a 'waiting list' control group. The primary outcome is change in objectively measured child physical activity using Actigraph accelerometry. Secondary outcomes in the child, included in part to shape a future more definitive randomised controlled trial, are: total time spent sedentary and patterning of sedentary behaviour (Actigraph accelerometry); body composition and bone health from dual energy x-ray absorptiometry; body weight, height and BMI; and finally, health-related quality of life using the PedsQL. Secondary outcomes in parents and dogs are: changes in body weight; changes in Actigraph accelerometry measured physical activity and sedentary behaviour. Process evaluation will consist of assessment of simultaneous child, parent, and dog accelerometry data and brief interviews with participating families. The Children, Parents, and Pets Exercising Together trial should be the first randomised controlled study to establish and evaluate an intervention aimed at dog-based physical activity promotion in families. It should advance our

  12. Children, parents, and pets exercising together (CPET randomised controlled trial: study rationale, design, and methods

    Directory of Open Access Journals (Sweden)

    Yam Philippa S

    2012-03-01

    Full Text Available Abstract Background Objectively measured physical activity is low in British children, and declines as childhood progresses. Observational studies suggest that dog-walking might be a useful approach to physical activity promotion in children and adults, but there are no published public health interventions based on dog-walking with children. The Children, Parents, and Pets Exercising Together Study aims to develop and evaluate a theory driven, generalisable, family-based, dog walking intervention for 9-11 year olds. Methods/design The Children, Parents, and Pets Exercising Together Study is an exploratory, assessor-blinded, randomised controlled trial as defined in the UK MRC Framework on the development and evaluation of complex interventions in public health. The trial will follow CONSORT guidance. Approximately 40 dog-owning families will be allocated randomly in a ratio of 1.5:1 to receive a simple behavioural intervention lasting for 10 weeks or to a 'waiting list' control group. The primary outcome is change in objectively measured child physical activity using Actigraph accelerometry. Secondary outcomes in the child, included in part to shape a future more definitive randomised controlled trial, are: total time spent sedentary and patterning of sedentary behaviour (Actigraph accelerometry; body composition and bone health from dual energy x-ray absorptiometry; body weight, height and BMI; and finally, health-related quality of life using the PedsQL. Secondary outcomes in parents and dogs are: changes in body weight; changes in Actigraph accelerometry measured physical activity and sedentary behaviour. Process evaluation will consist of assessment of simultaneous child, parent, and dog accelerometry data and brief interviews with participating families. Discussion The Children, Parents, and Pets Exercising Together trial should be the first randomised controlled study to establish and evaluate an intervention aimed at dog-based physical

  13. Effects of circuit training as alternative to usual physiotherapy after stroke: randomised controlled trial

    NARCIS (Netherlands)

    van de Port, I.G.L.; Wevers, L.E.G.; Lindeman, E.; Kwakkel, G.

    2012-01-01

    Objective: To analyse the effect of task oriented circuit training compared with usual physiotherapy in terms of self reported walking competency for patients with stroke discharged from a rehabilitation centre to their own home. Design: Randomised controlled trial with follow-up to 24 weeks.

  14. Alternativas para favorecer la polinización y producción de semilla del híbrido h-311 de maíz

    Directory of Open Access Journals (Sweden)

    Alejandro Espinosa

    2001-01-01

    Full Text Available Alternativas para favorecer la polinización y producción de semilla del híbrido H-311 de maíz. En la producción de semilla de híbridos de maíz es fundamental la coincidencia en floración de los progenitores y la disposición de los estigmas con respecto a las panojas que emiten polen. El híbrido de maíz H-311, se recomienda en México para siembras de riego, en alturas de 1200 a 1800 msnm. El orden de cruza inicial fue: (B16XB17 X (B32XB33; sin embargo, se cambio al orden inverso, es decir, (B32XB33 X (B16XB17, debido a mayor productividad y semilla de buena calidad física. La cruza simple (B16XB17 es enana (braquítico, al no haber suficiente viento en la época de polinización, se dificulta el cruzamiento y se requiere levantar el polen con mochilas de motor, la cruza simple B16XB17, rinde de 4,5 a 5,5 t/ha de semilla contra 6,0 a 7,5 t/ha de la cruza simple B32XB33; La cruza simple B16XB17, responde con alargamiento del porte por la influencia del tratamientos, con ácido giberélico (Activol, 20, 40 y 60 ppm, dos dosis de Cloruro de Mepiquat (PIX, 1 y 2 lt/ha, así como tres niveles de fertilización (400-70-30, 150-70-30 y 150- 300-30. En rendimiento hubo un efecto positivo por el manejo de ambos progenitores con diferentes fertilizaciones así como aplicación de fitohormonas, al aplicar ácido giberélico (20 ppm, el rendimiento se incrementó en 250,3% y 211,8% para las cruzas simples B32XB33 y B16XB17 respectivamente. La altura de planta de B16XB17 fue ligeramente afectada (106,0% con ácido giberélico, 40 ppm

  15. Actuaciones para el control y erradicación del teosinte (Zea mays spp.) en Aragón

    OpenAIRE

    Pardo Sanclemente, Gabriel; Fuertes, S.; Betrán, E.; Cirujeda Ranzenberger, Alicia

    2015-01-01

    En el verano de 2014 se tuvo constancia de la presencia de teosinte (Zea mays spp.) como mala hierba en campos de maíz de Aragón y en menos medida en Cataluña. Se conoce por teosinte a un grupo de especies y subespecies del género Zea, la mayoría de ellas de la misma especie que el maíz y originarias de Méjico. El maíz actual procede de antiguos teosintes mejorados, tras miles de años de selección. Debido al potencial infestante y competidor de esta especie, la Dirección General de Alimentaci...

  16. FODMAPs alter symptoms and the metabolome of patients with IBS: a randomised controlled trial.

    Science.gov (United States)

    McIntosh, Keith; Reed, David E; Schneider, Theresa; Dang, Frances; Keshteli, Ammar H; De Palma, Giada; Madsen, Karen; Bercik, Premysl; Vanner, Stephen

    2017-07-01

    To gain mechanistic insights, we compared effects of low fermentable oligosaccharides, disaccharides and monosaccharides and polyols (FODMAP) and high FODMAP diets on symptoms, the metabolome and the microbiome of patients with IBS. We performed a controlled, single blind study of patients with IBS (Rome III criteria) randomised to a low (n=20) or high (n=20) FODMAP diet for 3 weeks. Symptoms were assessed using the IBS symptom severity scoring (IBS-SSS). The metabolome was evaluated using the lactulose breath test (LBT) and metabolic profiling in urine using mass spectrometry. Stool microbiota composition was analysed by 16S rRNA gene profiling. Thirty-seven patients (19 low FODMAP; 18 high FODMAP) completed the 3-week diet. The IBS-SSS was reduced in the low FODMAP diet group (pmetabolome. In subsets of patients, FODMAPs modulate histamine levels and the microbiota, both of which could alter symptoms. NCT01829932. 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/.

  17. Risk of bias assessment of randomised controlled trials in high-impact ophthalmology journals and general medical journals: a systematic review.

    Science.gov (United States)

    Joksimovic, Lazar; Koucheki, Robert; Popovic, Marko; Ahmed, Yusuf; Schlenker, Matthew B; Ahmed, Iqbal Ike K

    2017-10-01

    Evidence-based treatments in ophthalmology are often based on the results of randomised controlled trials. Biased conclusions from randomised controlled trials may lead to inappropriate management recommendations. This systematic review investigates the prevalence of bias risk in randomised controlled trials published in high-impact ophthalmology journals and ophthalmology trials from general medical journals. Using Ovid MEDLINE, randomised controlled trials in the top 10 high-impact ophthalmology journals in 2015 were systematically identified and critically appraised for the prevalence of bias risk. Included randomised controlled trials were assessed in all domains of bias as defined by the Cochrane Collaboration. In addition, the prevalence of conflict of interest and industry sponsorship was investigated. A comparison with ophthalmology articles from high-impact general medical journals was performed. Of the 259 records that were screened from ophthalmology-specific journals, 119 trials met all inclusion criteria and were critically appraised. In total, 29.4% of domains had an unclear risk, 13.8% had a high risk and 56.8% had a low risk of bias. In comparison, ophthalmology articles from general medical journals had a lower prevalence of unclear risk (17.1%), higher prevalence of high risk (21.9%) and a higher prevalence of low risk domains (61.9%). Furthermore, 64.7% of critically appraised trials from ophthalmology-specific journals did not report any conflicts of interest, while 70.6% did not report an industry sponsor of their trial. In closing, it is essential that authors, peer reviewers and readers closely follow published risk of bias guidelines. © 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.

  18. A randomised controlled trial investigating the benefits of adaptive working memory training for working memory capacity and attentional control in high worriers.

    Science.gov (United States)

    Hotton, Matthew; Derakshan, Nazanin; Fox, Elaine

    2018-01-01

    The process of worry has been associated with reductions in working memory capacity and availability of resources necessary for efficient attentional control. This, in turn, can lead to escalating worry. Recent investigations into working memory training have shown improvements in attentional control and cognitive performance in high trait-anxious individuals and individuals with sub-clinical depression. The current randomised controlled trial investigated the effects of 15 days of adaptive n-back working memory training, or an active control task, on working memory capacity, attentional control and worry in a sample of high worriers. Pre-training, post-training and one-month follow-up measures of working memory capacity were assessed using a Change Detection task, while a Flanker task was used to assess attentional control. A breathing focus task was used as a behavioural measure of worry in addition to a number of self-report assessments of worry and anxiety. Overall there was no difference between the active training and the active control condition with both groups demonstrating similar improvements in working memory capacity and worry, post-training and at follow-up. However, training-related improvements on the n-back task were associated with gains in working memory capacity and reductions in worry symptoms in the active training condition. These results highlight the need for further research investigating the role of individual differences in working memory training. Copyright © 2017. Published by Elsevier Ltd.

  19. Lower education predicts poor response to dietary intervention in pregnancy, regardless of neighbourhood affluence: secondary analysis from the ROLO randomised control trial.

    Science.gov (United States)

    O'Brien, Eileen C; Alberdi, Goiuri; Geraghty, Aisling A; McAuliffe, Fionnuala M

    2017-11-01

    To determine if response to a low glycaemic index (GI) dietary intervention, measured by changes in dietary intake and gestational weight gain, differed across women of varying socio-economic status (SES). Secondary data analysis of the ROLO randomised control trial. The intervention consisted of a two-hour low-GI dietary education session in early pregnancy. Change in GI was measured using 3 d food diaries pre- and post-intervention. Gestational weight gain was categorised as per the 2009 Institute of Medicine guidelines. SES was measured using education and neighbourhood deprivation. The National Maternity Hospital, Dublin, Ireland. Women (n 625) recruited to the ROLO randomised control trial. The intervention significantly reduced GI and excess gestational weight gain (EGWG) among women with third level education residing in both disadvantaged (GI, mean (sd), intervention v. control: -3·30 (5·15) v. -0·32 (4·22), P=0·024; EGWG, n (%), intervention v. control: 7 (33·6) v. 22 (67·9); P=0·022) and advantaged areas (GI: -1·13 (3·88) v. 0·06 (3·75), P=0·020; EGWG: 41 (34·1) v. 58 (52·6); P=0·006). Neither GI nor gestational weight gain differed between the intervention and control group among women with less than third level education, regardless of neighbourhood deprivation. A single dietary education session was not effective in reducing GI or gestational weight gain among less educated women. Multifaceted, appropriate and practical approaches are required in pregnancy interventions to improve pregnancy outcomes for less educated women.

  20. 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.

  1. Effectiveness of anodal transcranial direct current stimulation in patients with chronic low back pain: Design, method and protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Luedtke Kerstin

    2011-12-01

    Full Text Available Abstract Background Electrical stimulation of central nervous system areas with surgically implanted stimulators has been shown to result in pain relief. To avoid the risks and side effects of surgery, transcranial direct current stimulation is an option to electrically stimulate the motor cortex through the skull. Previous research has shown that transcranial direct current stimulation relieves pain in patients with fibromyalgia, chronic neuropathic pain and chronic pelvic pain. Evidence indicates that the method is pain free, safe and inexpensive. Methods/Design A randomised controlled trial has been designed to evaluate the effect of transcranial direct current stimulation over the motor cortex for pain reduction in patients with chronic low back pain. It will also investigate whether transcranial direct current stimulation as a prior treatment enhances the symptom reduction achieved by a cognitive-behavioural group intervention. Participants will be randomised to receive a series of 5 days of transcranial direct current stimulation (2 mA, 20 mins or 20 mins of sham stimulation; followed by a cognitive-behavioural group programme. The primary outcome parameters will measure pain (Visual Analog Scale and disability (Oswestry Disability Index. Secondary outcome parameters will include the Fear Avoidance Beliefs Questionnaire, the Funktionsfragebogen Hannover (perceived function, Hospital Anxiety Depression Scale, bothersomeness and Health Related Quality of Life (SF 36, as well as Patient-Perceived Satisfactory Improvement. Assessments will take place immediately prior to the first application of transcranial direct current stimulation or sham, after 5 consecutive days of stimulation, immediately after the cognitive-behavioural group programme and at 4 weeks, 12 weeks and 24 weeks follow-up. Discussion This trial will help to determine, whether transcranial direct current stimulation is an effective treatment for patients with chronic low back

  2. Design and construction of program frame software of 300 keV/20 mA EBM control panel computerized base

    International Nuclear Information System (INIS)

    Eko Priyono; Saminto

    2015-01-01

    The program frame software of computer based control panel for 300 keV/20 mA EBM has been designed and constructed. This software is used for EBM components operating system, EBM operating parameters monitor and control system. This software contain instructions program for acquisition, actuation, process and display operation parameters data which is made by using visual basic V.6. This software displays some menus i.e. cover menu, main menu, sub menu and sub-sub menu. Performance test was done by integrating software and hardware and then operated the EBM via computer device. The test show that data communication between software and hardware was suitable, EBM components can be operated via computer device, EMB operation parameters can be controlled and monitored in form digital number, bar graph and continuous graphics the device can execute properly all instruction output program of 300 keV/20 mA control panel so the device is ready to use as one of computerize operating system of 300 keV/20 mA. (author)

  3. Producción de maíz y soya forrajera para ensilaje y venta parcial de la cosecha de elotes o chilotes

    Directory of Open Access Journals (Sweden)

    Carlos Jim\\u00E9nez

    2002-01-01

    Full Text Available Este trabajo investigó el efecto de tres diferentes formas de siembra conjunta de maíz y soya: a asociados (un surco maíz-un surco soya, b alternos (cuatro surcos máiz-cuatro surcos soya y c monocultivo y tres formas de cosecha de chilotes o elotes para venta antes de ensilar: a remoción del 50% de los chilotes (a inicio de floración, b remoción del 50% de los elotes (en estado de leche y c sin cosecha. Cada tratamiento tuvo tres repeticiones. Se utilizó la variedad de maíz blanco localmente adaptado, HS-5G de la casa Cristiani Burkard y la variedad de soya CIGRAS 10 para grano y forraje, desarrollada por el Centro de Investigación en Granos y Semillas de la Universidad de Costa Rica y probada con éxito en la regi ón. La cosecha para ensilaje, se realizó en los estados fenol ógicos de inicio de indentación en el maíz y R6 en la soya (semilla formada de consistencia semidura. La remoción del 50% del chilote resultó en $164,06 de ingreso bruto, cubriendo el 44,23 % de los gastos de cultivo, cosecha y almacenamiento en un silo de montón. Sin embargo, se observó una reducci ón desde 5,99 a 4,77 t MS /ha, representando un 20,3 %. La cosecha de elotes también redujo los rendimientos en un 24,4 %, pero permitió recuperar un 89,45 % de los gastos, que equivalieron a $331,75 de ingreso. Al mover los elotes, recupera casi todos los costos, no obstante, hay una reducción en tonelaje y casi de seguro en materia seca digestible. Bajo mejores condiciones de clima, un ingreso bruto mayor sería posible con el consecuente superavit monetario y el ensilaje gratis.

  4. Erythropoietin in traumatic brain injury: study protocol for a randomised controlled trial.

    LENUS (Irish Health Repository)

    Nichol, Alistair

    2015-02-08

    Traumatic brain injury is a leading cause of death and disability worldwide. Laboratory and clinical studies demonstrate a possible beneficial effect of erythropoietin in improving outcomes in the traumatic brain injury cohort. However, there are concerns regarding the association of erythropoietin and thrombosis in the critically ill. A large-scale, multi-centre, blinded, parallel-group, placebo-controlled, randomised trial is currently underway to address this hypothesis.

  5. CONSORT recommendations in abstracts of randomised, controlled trials on migraine and headache

    DEFF Research Database (Denmark)

    Tfelt-Hansen, Peer Carsten

    2011-01-01

    A CONSORT statement on the content of abstracts of randomised, controlled trials (RCTs) was published in 2008. I therefore reviewed the abstracts from 2009 to 2010 published on RCTs in Cephalalgia, Headache and other (non-headache) journals. The following items were reviewed: number of patients, ....... The influence of the CONSORT statement on reporting in abstracts has so far only had a limited influence on the headache literature....

  6. Are specialist outreach clinics for orthodontic consultation effective? A randomised controlled trial

    OpenAIRE

    Mandall, Nicola; O'Brien, K.

    2001-01-01

    Objective To develop outreach clinics for orthodontic consultation and evaluate their costs and effectiveness. Design Single centre randomised controlled trial with random allocation of referred patients to outreach or main base consultation appointments. Setting One hospital orthodontic department and three community health centre clinics in Greater Manchester. Subjects 324 patients who were referred for orthodontic treatment. Main outcome measures The outcome of consultation, the cost and d...

  7. Multicentre randomised study of the effect and experience of an early inhome programme (PreHomeCare) for preterm infants using video consultation and smartphone applications compared with inhospital consultations

    DEFF Research Database (Denmark)

    Hägi-Pedersen, Mai-Britt; Norlyk, Annelise; Dessau, Ram B

    2017-01-01

    ) in Denmark. Parents of hospitalised premature infants who fulfil the inclusion criteria for PreHomeCare will be randomised during hospitalisation to either the intervention (n=80) or control group (n=80) using 1:1 block randomisation. During PreHomeCare, the intervention group will receive a smartphone...

  8. Parent-mediated communication-focused treatment in children with autism (PACT): a randomised controlled trial.

    Science.gov (United States)

    Green, Jonathan; Charman, Tony; McConachie, Helen; Aldred, Catherine; Slonims, Vicky; Howlin, Pat; Le Couteur, Ann; Leadbitter, Kathy; Hudry, Kristelle; Byford, Sarah; Barrett, Barbara; Temple, Kathryn; Macdonald, Wendy; Pickles, Andrew

    2010-06-19

    Results of small trials suggest that early interventions for social communication are effective for the treatment of autism in children. We therefore investigated the efficacy of such an intervention in a larger trial. Children with core autism (aged 2 years to 4 years and 11 months) were randomly assigned in a one-to-one ratio to a parent-mediated communication-focused (Preschool Autism Communication Trial [PACT]) intervention or treatment as usual at three specialist centres in the UK. Those assigned to PACT were also given treatment as usual. Randomisation was by use of minimisation of probability in the marginal distribution of treatment centre, age (42 months), and autism severity (Autism Diagnostic Observation Schedule-Generic [ADOS-G] algorithm score 12-17 or 18-24). Primary outcome was severity of autism symptoms (a total score of social communication algorithm items from ADOS-G, higher score indicating greater severity) at 13 months. Complementary secondary outcomes were measures of parent-child interaction, child language, and adaptive functioning in school. Analysis was by intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN58133827. 152 children were recruited. 77 were assigned to PACT (London [n=26], Manchester [n=26], and Newcastle [n=25]); and 75 to treatment as usual (London [n=26], Manchester [n=26], and Newcastle [n=23]). At the 13-month endpoint, the severity of symptoms was reduced by 3.9 points (SD 4.7) on the ADOS-G algorithm in the group assigned to PACT, and 2.9 (3.9) in the group assigned to treatment as usual, representing a between-group effect size of -0.24 (95% CI -0.59 to 0.11), after adjustment for centre, sex, socioeconomic status, age, and verbal and non-verbal abilities. Treatment effect was positive for parental synchronous response to child (1.22, 0.85 to 1.59), child initiations with parent (0.41, 0.08 to 0.74), and for parent-child shared attention (0.33, -0.02 to

  9. Motor control or graded activity exercises for chronic low back pain? A randomised controlled trial

    Science.gov (United States)

    Macedo, Luciana G; Latimer, Jane; Maher, Chris G; Hodges, Paul W; Nicholas, Michael; Tonkin, Lois; McAuley, James H; Stafford, Ryan

    2008-01-01

    Background Chronic low back pain remains a major health problem in Australia and around the world. Unfortunately the majority of treatments for this condition produce small effects because not all patients respond to each treatment. It appears that only 25–50% of patients respond to exercise. The two most popular types of exercise for low back pain are graded activity and motor control exercises. At present however, there are no guidelines to help clinicians select the best treatment for a patient. As a result, time and money are wasted on treatments which ultimately fail to help the patient. Methods This paper describes the protocol of a randomised clinical trial comparing the effects of motor control exercises with a graded activity program in the treatment of chronic non specific low back pain. Further analysis will identify clinical features that may predict a patient's response to each treatment. One hundred and seventy two participants will be randomly allocated to receive either a program of motor control exercises or graded activity. Measures of outcome will be obtained at 2, 6 and 12 months after randomisation. The primary outcomes are: pain (average pain intensity over the last week) and function (patient-specific functional scale) at 2 and 6 months. Potential treatment effect modifiers will be measured at baseline. Discussion This trial will not only evaluate which exercise approach is more effective in general for patients will chronic low back pain, but will also determine which exercise approach is best for an individual patient. Trial registration number ACTRN12607000432415 PMID:18454877

  10. Motor control or graded activity exercises for chronic low back pain? A randomised controlled trial

    Directory of Open Access Journals (Sweden)

    McAuley James H

    2008-05-01

    Full Text Available Abstract Background Chronic low back pain remains a major health problem in Australia and around the world. Unfortunately the majority of treatments for this condition produce small effects because not all patients respond to each treatment. It appears that only 25–50% of patients respond to exercise. The two most popular types of exercise for low back pain are graded activity and motor control exercises. At present however, there are no guidelines to help clinicians select the best treatment for a patient. As a result, time and money are wasted on treatments which ultimately fail to help the patient. Methods This paper describes the protocol of a randomised clinical trial comparing the effects of motor control exercises with a graded activity program in the treatment of chronic non specific low back pain. Further analysis will identify clinical features that may predict a patient's response to each treatment. One hundred and seventy two participants will be randomly allocated to receive either a program of motor control exercises or graded activity. Measures of outcome will be obtained at 2, 6 and 12 months after randomisation. The primary outcomes are: pain (average pain intensity over the last week and function (patient-specific functional scale at 2 and 6 months. Potential treatment effect modifiers will be measured at baseline. Discussion This trial will not only evaluate which exercise approach is more effective in general for patients will chronic low back pain, but will also determine which exercise approach is best for an individual patient. Trial registration number ACTRN12607000432415

  11. Cost-effectiveness of cryotherapy versus salicylic acid for the treatment of plantar warts: economic evaluation alongside a randomised controlled trial (EVerT trial

    Directory of Open Access Journals (Sweden)

    Stamuli Eugena

    2012-02-01

    Full Text Available Abstract Background Plantar warts (verrucae are extremely common. Although many will spontaneously disappear without treatment, treatment may be sought for a variety of reasons such as discomfort. There are a number of different treatments for cutaneous warts, with salicylic acid and cryotherapy using liquid nitrogen being two of the most common forms of treatment. To date, no full economic evaluation of either salicylic acid or cryotherapy has been conducted based on the use of primary data in a pragmatic setting. This paper describes the cost-effectiveness analysis which was conducted alongside a pragmatic multicentre, randomised trial evaluating the clinical effectiveness of cryotherapy versus 50% salicylic acid of the treatment of plantar warts. Methods A cost-effectiveness analysis was undertaken alongside a pragmatic multicentre, randomised controlled trial assessing the clinical effectiveness of 50% salicylic acid and cryotherapy using liquid nitrogen at 12 weeks after randomisation of patients. Cost-effectiveness outcomes were expressed as the additional cost required to completely cure the plantar warts of one additional patient. A NHS perspective was taken for the analysis. Results Cryotherapy costs on average £101.17 (bias corrected and accelerated (BCA 95% CI: 85.09-117.26 more per participant over the 12 week time-frame, while there is no additional benefit, in terms of proportion of patients healed compared with salicylic acid. Conclusions Cryotherapy is more costly and no more effective than salicylic acid. Trial registration Current Controlled Trials ISRCTN18994246 [controlled-trials.com] and National Research Register N0484189151.

  12. Cost-effectiveness of cryotherapy versus salicylic acid for the treatment of plantar warts: economic evaluation alongside a randomised controlled trial (EVerT trial)

    Science.gov (United States)

    2012-01-01

    Abstract Background Plantar warts (verrucae) are extremely common. Although many will spontaneously disappear without treatment, treatment may be sought for a variety of reasons such as discomfort. There are a number of different treatments for cutaneous warts, with salicylic acid and cryotherapy using liquid nitrogen being two of the most common forms of treatment. To date, no full economic evaluation of either salicylic acid or cryotherapy has been conducted based on the use of primary data in a pragmatic setting. This paper describes the cost-effectiveness analysis which was conducted alongside a pragmatic multicentre, randomised trial evaluating the clinical effectiveness of cryotherapy versus 50% salicylic acid of the treatment of plantar warts. Methods A cost-effectiveness analysis was undertaken alongside a pragmatic multicentre, randomised controlled trial assessing the clinical effectiveness of 50% salicylic acid and cryotherapy using liquid nitrogen at 12 weeks after randomisation of patients. Cost-effectiveness outcomes were expressed as the additional cost required to completely cure the plantar warts of one additional patient. A NHS perspective was taken for the analysis. Results Cryotherapy costs on average £101.17 (bias corrected and accelerated (BCA) 95% CI: 85.09-117.26) more per participant over the 12 week time-frame, while there is no additional benefit, in terms of proportion of patients healed compared with salicylic acid. Conclusions Cryotherapy is more costly and no more effective than salicylic acid. Trial registration Current Controlled Trials ISRCTN18994246 [controlled-trials.com] and National Research Register N0484189151. PMID:22369511

  13. A Scoping Review of Economic Evaluations Alongside Randomised Controlled Trials of Home Monitoring in Chronic Disease Management.

    Science.gov (United States)

    Kidholm, Kristian; Kristensen, Mie Borch Dahl

    2018-04-01

    Many countries have considered telemedicine and home monitoring of patients as a solution to the demographic challenges that health-care systems face. However, reviews of economic evaluations of telemedicine have identified methodological problems in many studies as they do not comply with guidelines. The aim of this study was to examine economic evaluations alongside randomised controlled trials of home monitoring in chronic disease management and hereby to explore the resources included in the programme costs, the types of health-care utilisation that change as a result of home monitoring and discuss the value of economic evaluation alongside randomised controlled trials of home monitoring on the basis of the studies identified. A scoping review of economic evaluations of home monitoring of patients with chronic disease based on randomised controlled trials and including information on the programme costs and the costs of equipment was carried out based on a Medline (PubMed) search. Nine studies met the inclusion criteria. All studies include both costs of equipment and use of staff, but there is large variation in the types of equipment and types of tasks for the staff included in the costs. Equipment costs constituted 16-73% of the total programme costs. In six of the nine studies, home monitoring resulted in a reduction in primary care or emergency contacts. However, in total, home monitoring resulted in increased average costs per patient in six studies and reduced costs in three of the nine studies. The review is limited by the small number of studies found and the restriction to randomised controlled trials, which can be problematic in this area due to lack of blinding of patients and healthcare professionals and the difficulty of implementing organisational changes in hospital departments for the limited period of a trial. Furthermore, our results may be based on assessments of older telemedicine interventions.

  14. Randomised controlled trial and economic evaluation of the 'Families for Health' programme to reduce obesity in children.

    Science.gov (United States)

    Robertson, Wendy; Fleming, Joanna; Kamal, Atiya; Hamborg, Thomas; Khan, Kamran A; Griffiths, Frances; Stewart-Brown, Sarah; Stallard, Nigel; Petrou, Stavros; Simkiss, Douglas; Harrison, Elizabeth; Kim, Sung Wook; Thorogood, Margaret

    2017-05-01

    Evaluating effectiveness and cost-effectiveness of 'Families for Health V2' (FFH) compared with usual care (UC). Multicentre randomised controlled trial (RCT) (investigators blinded, families unblinded) and economic evaluation. Stratified randomisation by family; target of 120 families. Three National Health Service Primary Care Trusts in West Midlands, England. Overweight or obese (≥91st or ≥98th centile body mass index (BMI)) children aged 6-11 years and their parents/carers, recruited March 2012-February 2014. FFH; a 10-week community-based family programme addressing parenting, lifestyle change and social and emotional development. UC; usual support for childhood obesity at each site. Primary outcomes were 12-months change in children's BMI z-score and incremental cost per quality-adjusted life-year gained (QALY). Secondary outcomes included changes in children's physical activity, fruit and vegetable consumption and quality of life, parents' BMI and mental well-being, family eating/activity, parent-child relationships and parenting style. 115 families (128 children) were randomised to FFH (n=56) or UC (n=59). There was no significant difference in BMI z-score 12-months change (0.114, 95% CI -0.001 to 0.229, p=0.053; p=0.026 in favour of UC with missing value multiple imputation). One secondary outcome, change in children's waist z-score, was significantly different between groups in favour of UC (0.15, 95% CI 0.00 to 0.29). Economic evaluation showed that mean costs were significantly higher for FFH than UC (£998 vs £548, p<0.001). Mean incremental cost-effectiveness of FFH was estimated at £552 175 per QALY. FFH was neither effective nor cost-effective for the management of obesity compared with UC. ISRCTN45032201. 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/.

  15. SELECCIÓN DE AISLADOS DE HONGOS ENTOMOPATÓGENOS PARA EL CONTROL DE Rhipicephalus microplus (Acari: Ixodidae

    Directory of Open Access Journals (Sweden)

    Ana Martha Cruz-Avalos

    2015-08-01

    Full Text Available El objetivo del presente estudio fue evaluar la susceptibilidad in vitro de larvas no alimentadas de Rhipicephalus microplus a diferentes aislados de hongos entomopatógenos nativos de suelo de unidades ganaderas y conocer las características de crecimiento y potencial de inóculo de los aislados que mostraran ser más patógenos. Se evaluó la patogenicidad y virulencia de aislados de Metarhizium anisopliae sensu lato (Ma, Beauveria bassiana (Bb e, Isaria fumorosea (Ifr, en larvas de R. microplus de 7 días de edad, expuestas mediante inmersión en una solución acuosa a la concentración 1x108 conidios/ml. Los aislados Ma135 y Ma133, presentaron alta patogenicidad con 100 y 94% de mortalidad, con valores CL50 de 5.2x104 y 2.5x104 conidios/ml, respectivamente. En estos aislados, la producción de esporas fue de 1.0x10¹º conidios/ml, y el crecimiento radial de micelio fue de 3.07 y 3.60 mm/día, respectivamente. Estos resultados demuestran que los aislados Ma135 y Ma133, pueden ser considerados potenciales agentes de control biológico en larvas de R. microplus. Â

  16. Reduced in-hospital mortality for heart failure with clinical pathways: the results of a cluster randomised controlled trial.

    Science.gov (United States)

    Panella, M; Marchisio, S; Demarchi, M L; Manzoli, L; Di Stanislao, F

    2009-10-01

    Hospital treatment of heart failure (HF) frequently does not follow published guidelines, potentially contributing to HF high morbidity, mortality and economic cost. The Experimental Prospective Study on the Effectiveness and Efficiency of the Implementation of Clinical Pathways was undertaken to determine how clinical pathways (CP) for hospital treatment of HF affected care variability, guidelines adherence, in-hospital mortality and outcomes at discharge. Methods/ Two-arm, cluster-randomised trial. Fourteen community hospitals were randomised either to the experimental arm (CP: appropriate therapeutic guidelines use, new organisation and procedures, patient education) or to the control arm (usual care). The main outcome was in-hospital mortality; secondary outcomes were length and appropriateness of the stay, rate of unscheduled readmissions, customer satisfaction, usage of diagnostic and therapeutic procedures during hospital stay and quality indicators at discharge. All outcomes were measured using validated instruments available in literature. In-hospital mortality was 5.6% in the experimental arm (n = 12); 15.4% in controls (n = 33, p = 0.001). In CP and usual care groups, the mean rates of unscheduled readmissions were 7.9% and 13.9%, respectively. Adjusting for age, smoking, New York Heart Association score, hypertension and source of referral, patients in the CP group, as compared to controls, had a significantly lower risk of in-hospital death (OR 0.18; 95% CI 0.07 to 0.46) and unscheduled readmissions (OR 0.42; 95% CI 0.20 to 0.87). No differences were found between CP and control with respect to the appropriateness of the stay, costs and patient's satisfaction. Except for electrocardiography, all recommended diagnostic procedures were used more in the CP group. Similarly, pharmaceuticals use was significantly greater in CP, with the exception of diuretics and anti-platelets agents. The introduction of a specifically tailored CP for the hospital

  17. Effectiveness of adenoidectomy in children with recurrent upper respiratory tract infections: open randomised controlled trial.

    NARCIS (Netherlands)

    Aardweg, M.T. van den; Boonacker, C.W.; Rovers, M.M.; Hoes, A.W.; Schilder, A.G.M.

    2011-01-01

    OBJECTIVE: To assess the effectiveness of adenoidectomy in children with recurrent upper respiratory tract infections. DESIGN: Open randomised controlled trial. SETTING: 11 general hospitals and two academic centres. PARTICIPANTS: 111 children aged 1-6 with recurrent upper respiratory tract

  18. Financial incentives for improving adherence to maintenance treatment in patients with psychotic disorders (Money for Medication): a multicentre, open-label, randomised controlled trial.

    Science.gov (United States)

    Noordraven, Ernst L; Wierdsma, André I; Blanken, Peter; Bloemendaal, Anthony F T; Staring, Anton B P; Mulder, Cornelis L

    2017-03-01

    Provision of financial incentives is a promising intervention for improving adherence in patients taking antipsychotic medication. We aimed to assess the effectiveness of this intervention for improving adherence to antipsychotic depot medication in patients with psychotic disorders, irrespective of their previous compliance. We did this multicentre, open-label, randomised controlled trial at three mental health-care institutions in secondary psychiatric care services in the Netherlands. Eligible patients were aged 18-65 years, had been diagnosed with schizophrenia or another psychotic disorder, had been prescribed antipsychotic depot medication or had an indication to start using depot medication, and were participating in outpatient treatment. Patients were randomly assigned (1:1), via computer-generated randomisation with a block size of four, to receive 12 months of either treatment as usual plus a financial reward for each depot of medication received (€30 per month if fully compliant; intervention group) or treatment as usual alone (control group). Randomisation was stratified by treatment site and suspected prognostic factors: sex, comorbid substance-use disorder (absent vs present), and compliance with antipsychotic medication in the 4 months before baseline (taking antipsychotic medication. We did analysis by intention to treat. This trial is registered with the Nederlands Trial Register, number NTR2350. Between May 21, 2010, and Oct 15, 2014, we randomly assigned 169 patients to the intervention group (n=84) or the control group (n=85). Primary outcome data were available for 155 (92%) patients. At baseline, the mean MPR was 76·0% (SD 28·2%) in the intervention group versus 77·9% (28·5%) in the control group. At 12 months, the mean MPR was higher in the intervention group (94·3% [SD 11·3%]) than in the control group (80·3% [19·1%]), with an adjusted difference of 14·9% (95% CI 8·9-20·9%; pcontrol group (adjusted difference 6·5%, 95% CI 2·0

  19. Sexual health clinics for women led by specialist nurses or senior house officers in a central London GUM service: a randomised controlled trial.

    Science.gov (United States)

    Miles, K; Penny, N; Mercey, D; Power, R

    2002-04-01

    To assess the care process and clinical outcomes for two different models of GUM clinic for women: one led by specialist nurses and the other by senior house officers (SHOs). An open randomised controlled trial was carried out in a central London genitourinary medicine (GUM) women's clinic. Of 1172 women telephoning for an appointment, 880 were randomised to provide 169 eligible patients in the specialist nurse arm and 178 in the SHO arm. Of the eligible patients a total of 224 attended their appointment. The clinical records of the randomised women were audited for adequacy of care according to local guidelines. 30 key variables were objectively assessed and recorded on a standard audit form. An overall unitary index score (%) was calculated for each patient. The main variables associated with the outcome of specialist nurse and SHO decision making (diagnostic test request, preliminary diagnosis, and treatment provided) were then analysed independently. The median documentation audit scores for specialist nurses (n=103) and SHOs (n=121) were 92% and 85% respectively (pnurses' documentation was significantly (pnurses performed equally to the SHOs with regard to requesting the correct diagnostic tests, providing the correct preliminary diagnosis, and providing the correct treatment. A model of care using trained GUM nurses working within agreed protocols can provide comprehensive patient care for female patients that is equal to care provided by SHOs. Our results raise important issues regarding advanced GUM nursing education and training, protocol development, and accountability.

  20. Danışma Hizmetlerinde Bulut Bilişim Uygulamalarının Kullanımı = Use of Cloud Computing Applications in Reference Services

    Directory of Open Access Journals (Sweden)

    Canan Tavluoğlu

    2014-12-01

    Full Text Available Bulut bilişim, herhangi bir yazılım ve depolama birimi olmaksızın, masaüstü-dizüstü bilgisayar, tablet PC veya akıllı telefonlar kullanılarak internet üzerinden bilgiye erişim sağlayan bir bilişim platformudur. Kütüphaneler gibi birçok kurum zamandan ve paradan tasarruf etmek için bu uygulamaları kullanmaktadır. Kütüphaneler danışma hizmetlerini yeni teknolojilere göre uyarlamakta ve hizmetlerini söz konusu bilişim ortamına taşımaktadır. Bu çalışmada bulut bilişimin tanımı, sunduğu fırsatlar ve zorluklardan kısaca bahsedilmekte ayrıca danışma hizmetlerinde bulut tabanlı uygulamaların nasıl kullanılabileceğine yer verilmektedir. Bu bağlamda Ankara’da bulunan üniversite kütüphanelerinde çalışan danışma kütüphanecilerinin bulut tabanlı yazılım olarak hizmet (Software as a Service - SaaS araçlarının ne ölçüde kullandıklarını belirlemek amacıyla bir anket uygulanmıştır. Anket sonuçlarına göre, danışma hizmetlerinde bu araçların kullanım oranlarının çok düşük olduğu görülmektedir. / Cloud computing is a computing platform that allows access the information over internet by using desktop computers, laptops, tablet PCs and smart phones without any software and storage unit. Many organizations use this technology and save time and money, such as libraries. Libraries have been adopting their reference services to the new technology and library services have been moving to the cloud. This paper defines cloud computing, presents the opportunities and challenges, also include how to use cloud based applications in reference services. A survey was applied to identify the use of cloud based Software as a Service (SaaS models by references librarians who work at university libraries in Ankara. According to results, the degree of usage of this tools generally low.

  1. Concurrent transcranial direct current stimulation and progressive resistance training in Parkinson's disease: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Hendy, Ashlee M; Tillman, Alex; Rantalainen, Timo; Muthalib, Makii; Johnson, Liam; Kidgell, Dawson J; Wundersitz, Daniel; Enticott, Peter G; Teo, Wei-Peng

    2016-07-19

    Parkinson's disease (PD) results from a loss of dopamine in the brain, leading to movement dysfunctions such as bradykinesia, postural instability, resting tremor and muscle rigidity. Furthermore, dopamine deficiency in PD has been shown to result in maladaptive plasticity of the primary motor cortex (M1). Progressive resistance training (PRT) is a popular intervention in PD that improves muscular strength and results in clinically significant improvements on the Unified Parkinson's Disease Rating Scale (UPDRS). In separate studies, the application of anodal transcranial direct current stimulation (a-tDCS) to the M1 has been shown to improve motor function in PD; however, the combined use of tDCS and PRT has not been investigated. We propose a 6-week, double-blind randomised controlled trial combining M1 tDCS and PRT of the lower body in participants (n = 42) with moderate PD (Hoehn and Yahr scale score 2-4). Supervised lower body PRT combined with functional balance tasks will be performed three times per week with concurrent a-tDCS delivered at 2 mA for 20 minutes (a-tDCS group) or with sham tDCS (sham group). Control participants will receive standard care (control group). Outcome measures will include functional strength, gait speed and variability, balance, neurophysiological function at rest and during movement execution, and the UPDRS motor subscale, measured at baseline, 3 weeks (during), 6 weeks (post), and 9 weeks (retention). Ethical approval has been granted by the Deakin University Human Research Ethics Committee (project number 2015-014), and the trial has been registered with the Australian New Zealand Clinical Trials Registry (ACTRN12615001241527). This will be the first randomised controlled trial to combine PRT and a-tDCS targeting balance and gait in people with PD. The study will elucidate the functional, clinical and neurophysiological outcomes of combined PRT and a-tDCS. It is hypothesised that combined PRT and a-tDCS will significantly

  2. La música del maíz: de los rituales agrarios mejicanos a la ilustración asturiana

    Directory of Open Access Journals (Sweden)

    Rubén Figadero Fernandez

    2012-01-01

    Full Text Available Este artículo es un esbozo, una puerta para una investigación de mayor extensión, que explicaría la existencia de un léxico musical y ritual común entre pueblos separados por un mar y por años de desencuentros, prejuicios y desconfianza. Encerrar aquí una realidad tan compleja como la que rodea al mundo del maíz en México y Asturias es como pretender leer las verdades de la naturaleza en una solo planta, o el carácter de una persona con una sola mirada. Este trabajo trata de dibujar unas relaciones de simetría entre mitos, ritos y costumbres unidas por el azar de un grano de maíz que atraviesa el océano y germina en una tierra hambrienta.

  3. A pilot randomised controlled trial of community-led ANtipsychotic Drug REduction for Adults with Learning Disabilities.

    Science.gov (United States)

    McNamara, Rachel; Randell, Elizabeth; Gillespie, David; Wood, Fiona; Felce, David; Romeo, Renee; Angel, Lianna; Espinasse, Aude; Hood, Kerry; Davies, Amy; Meek, Andrea; Addison, Katy; Jones, Glyn; Deslandes, Paul; Allen, David; Knapp, Martin; Thapar, Ajay; Kerr, Michael

    2017-08-01

    , the Modified Overt Aggression Scale, the Aberrant Behaviour Checklist, the Psychiatric Assessment Schedule for Adults with Developmental Disability checklist, the Antipsychotic Side-effect Checklist, the Dyskinesia Identification System Condensed User Scale, the Client Service Receipt Inventory, use of other interventions to manage challenging behaviour, use of as-required (pro re nata) medication and level of psychotropic medication use. Of the 22 participants randomised (intervention, n  = 11; control, n  = 11), 13 (59%) achieved progression through all four stages of reduction. Follow-up data at 6 and 9 months were obtained for 17 participants (intervention, n  = 10; and control, n  = 7; 77% of those randomised). There were no clinically important changes in participants' levels of aggression or challenging behaviour at the end of the study. There were no expedited safety reports. Four adverse events and one serious adverse event were reported during the trial. Recruitment was challenging, which was largely a result of difficulty in identifying appropriate persons to consent and carer concerns regarding re-emergence of challenging behaviour. Reduced recruitment meant that the full trial became an exploratory pilot study. The results indicate that drug reduction is possible and safe. However, concerns about taking part were probably exacerbated by limited availability of alternative (behavioural) interventions to manage behaviour; therefore, focused support and alternative interventions are required. The results of the qualitative study provide important insights into the experiences of people taking part in drug reduction studies that should influence future trial development. We recommend that further work focuses on support for practitioners, carers and patients in reducing antipsychotic medication. Current Controlled Trials ISRCTN38126962. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment

  4. Reading and Language Intervention for Children at Risk of Dyslexia: A Randomised Controlled Trial

    Science.gov (United States)

    Duff, Fiona J.; Hulme, Charles; Grainger, Katy; Hardwick, Samantha J.; Miles, Jeremy N. V.; Snowling, Margaret J.

    2014-01-01

    Background: Intervention studies for children at risk of dyslexia have typically been delivered preschool, and show short-term effects on letter knowledge and phoneme awareness, with little transfer to literacy. Methods: This randomised controlled trial evaluated the effectiveness of a reading and language intervention for 6-year-old children…

  5. Adición de vitaminas y minerales a harinas de maíz y de trigo en México

    Directory of Open Access Journals (Sweden)

    Rosado Jorge L.

    1999-01-01

    Full Text Available En México la deficiencia marginal de algunas vitaminas y minerales afecta la salud y la funcionalidad de un número elevado de mexicanos, por lo que la Secretaría de Salud ha iniciado un programa para promover la adición de nutrimentos a las harinas de trigo y de maíz que se procesan industrialmente. El presente documento expone las bases científicas y tecnológicas para dicha adición. El objetivo primordial es restaurar los nutrimentos que se pierden durante el proceso de obtención de las harinas y durante la fabricación de los alimentos a partir de las harinas; además, se adicionan aquellos nutrimentos cuya presencia es deficiente en una proporción importante de la población y cuya suplementación en la dieta ha demostrado ser benéfica en la salud y la funcionalidad de la población. En la definición de la fórmula para adicionar a las harinas de trigo y maíz se consideraron, además de los factores mencionados, los niveles de absorción de los diferentes nutrimentos, la interacción probable entre nutrimentos y un malgar muy amplio de seguridad, de manera que se eliminara cualquier riesgo de algún efecto adverso en la salud, aun en los niveles más altos de ingestión de los alimentos. Finalmente, se sugieren los compuestos más apropiados para la adición a las harinas considerando su reactividad y sus posibles efectos negativos en la estabilidad de las harinas, así como su biodisponibilidad, su disponibilidad en el mercado y su costo. Con lo anterior se recomienda la adición de 5 mg/kg de tiamina (mononitrato de tiamina, 3 mg/kg de riboflavina (hidroclorhidrato de riboflavina, 35 mg/kg de niacina (nicotinamida, 30 mg/kg de hierro (hierro reducido extrafino y 20 mg/kg de zinc (óxido de zinc para ambas harinas, así como 2 mg/kg y 0.5 mg/kg de ácido fólico para las harinas de trigo y maíz, respectivamente.

  6. The Banana Fruit SINA Ubiquitin Ligase MaSINA1 Regulates the Stability of MaICE1 to be Negatively Involved in Cold Stress Response.

    Science.gov (United States)

    Fan, Zhong-Qi; Chen, Jian-Ye; Kuang, Jian-Fei; Lu, Wang-Jin; Shan, Wei

    2017-01-01

    The regulation of ICE1 protein stability is important to ensure effective cold stress response, and is extensively studied in Arabidopsis . Currently, how ICE1 stability in fruits under cold stress is controlled remains largely unknown. Here, we reported the possible involvement of a SEVEN IN ABSENTIA (SINA) ubiquitin ligase MaSINA1 from banana fruit in affecting MaICE1 stability. MaSINA1 was identified based on a yeast two-hybrid screening using MaICE1 as bait. Further yeast two-hybrid, pull-down, bimolecular fluorescence complementation (BiFC) and co-immunoprecipitation (CoIP) assays confirmed that MaSINA1 interacted with MaICE1. The expression of MaSINA1 was repressed by cold stress. Subcellular localization analysis in tobacco leaves showed that MaSINA1 was localized predominantly in the nucleus. In vitro ubiquitination assay showed that MaSINA1 possessed E3 ubiquitin ligase activity. More importantly, in vitro and semi- in vivo experiments indicated that MaSINA1 can ubiquitinate MaICE1 for the 26S proteasome-dependent degradation, and therefore suppressed the transcriptional activation of MaICE1 to MaNAC1, an important regulator of cold stress response of banana fruit. Collectively, our data reveal a mechanism in banana fruit for control of the stability of ICE1 and for the negative regulation of cold stress response by a SINA E3 ligase via the ubiquitin proteasome system.

  7. Yetişkin Kadın Mağdurlarda Cinsel Saldırı Sonrası Görülen Ruhsal ve Sosyal Sorunlar

    Directory of Open Access Journals (Sweden)

    Zeynep Belma Gölge

    2014-07-01

    Full Text Available Amaç: Bu çalışmada, cinsel saldırı mağdurlarının tıbbi ve psikolojik yardım alma imkanının çok fazla olmadığı, adli sürecin yıllarca sürdüğü ülkemizde, cinsel saldırı sonrası ruhsal ve sosyal sorunların görülme oranı ve bu sorunlar ile çocukluk çağında yaşanan istismar arasındaki ilişki incelenmiştir. Yöntem: Çalışma grubu cinsel saldırı iddiası ile TC Adalet Bakanlığı Adli Tıp Kurumu II. İhtisas Kurulu’na muayene için gönderilen 93 kadından oluşmaktadır. Mağdurların değerlendirmesinde, sosyodemografik özelliklerini, saldırı karakteristiklerini,  ruhsal ve sosyal sorunlarını belirlemek amacıyla oluşturulan görüşme formu, Travma Sonrası Stres Tanı Ölçeği (TSTÖ ve Çocukluk Örselenme Yaşantıları Ölçeği (ÇÖYÖ kullanılmıştır. Sonuçlar: Mağdurların %61.3’ünde TSSB tanı kriterleri karşılanmış ve %54.8’inde cinsel sorunlar belirlenmiştir. Mağdurların  %68.8’i olumsuz sosyal reaksiyonlara maruz kaldığını ifade etmiştir. Olumsuz sosyal reaksiyonlara maruz kaldığını belirtenlerin % 70.3’ü TSSB tanısı alırken, olumsuz sosyal reaksiyonlara maruz kalmadığını belirtenlerin %41.4’ü TSSB tanısı almışlardır. Aralarında istatistiksel olarak anlamlı farklılık bulunmuştur; ki kare: 7.04; df: 1; p<0.01.  Çocukluk çağı duygusal istismar ile saldırı sonrası yaşanan TSSB arasında ve çocukluk çağı cinsel istismar ile intihar girişimi ve kendini yaralama davranışı arasında istatistiksel olarak anlamlı bir ilişki saptanmıştır. Tartışma: Cinsel saldırı ile görüşme arasında geçen süre dikkate alındığında çalışmamızda TSSB ve cinsel sorun yaşayanların oranı diğer çalışmalara nazaran daha yüksek bulunmuştur. Çalışmamızda saldırı ile görüşme arasında 3 yıldan fazla süre geçtiğini bildiren mağdurlarda dahi TSSB tanı kriterlerini karşılayanların oranı %58.8’dir. Bu

  8. When is a randomised controlled trial health equity relevant? Development and validation of a conceptual framework.

    Science.gov (United States)

    Jull, J; Whitehead, M; Petticrew, M; Kristjansson, E; Gough, D; Petkovic, J; Volmink, J; Weijer, C; Taljaard, M; Edwards, S; Mbuagbaw, L; Cookson, R; McGowan, J; Lyddiatt, A; Boyer, Y; Cuervo, L G; Armstrong, R; White, H; Yoganathan, M; Pantoja, T; Shea, B; Pottie, K; Norheim, O; Baird, S; Robberstad, B; Sommerfelt, H; Asada, Y; Wells, G; Tugwell, P; Welch, V

    2017-09-25

    Randomised controlled trials can provide evidence relevant to assessing the equity impact of an intervention, but such information is often poorly reported. We describe a conceptual framework to identify health equity-relevant randomised trials with the aim of improving the design and reporting of such trials. An interdisciplinary and international research team engaged in an iterative consensus building process to develop and refine the conceptual framework via face-to-face meetings, teleconferences and email correspondence, including findings from a validation exercise whereby two independent reviewers used the emerging framework to classify a sample of randomised trials. A randomised trial can usefully be classified as 'health equity relevant' if it assesses the effects of an intervention on the health or its determinants of either individuals or a population who experience ill health due to disadvantage defined across one or more social determinants of health. Health equity-relevant randomised trials can either exclusively focus on a single population or collect data potentially useful for assessing differential effects of the intervention across multiple populations experiencing different levels or types of social disadvantage. Trials that are not classified as 'health equity relevant' may nevertheless provide information that is indirectly relevant to assessing equity impact, including information about individual level variation unrelated to social disadvantage and potentially useful in secondary modelling studies. The conceptual framework may be used to design and report randomised trials. The framework could also be used for other study designs to contribute to the evidence base for improved health equity. © 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.

  9. Efficacy of metformin in pregnant obese women: a randomised controlled trial.

    Science.gov (United States)

    Chiswick, Carolyn A; Reynolds, Rebecca M; Denison, Fiona C; Whyte, Sonia A; Drake, Amanda J; Newby, David E; Walker, Brian R; Forbes, Shareen; Murray, Gordon D; Quenby, Siobhan; Wray, Susan; Norman, Jane E

    2015-01-14

    Increasing evidence suggests obesity has its origins prior to birth. There is clear correlation between maternal obesity, high birthweight and offspring risk of obesity in later life. It is also clear that women who are obese during pregnancy are at greater risk of adverse outcomes, including gestational diabetes and stillbirth. The mechanism(s) by which obesity causes these problems is unknown, although hyperglycaemia and insulin resistance are strongly implicated. We present a protocol for a study to test the hypothesis that metformin will improve insulin sensitivity in obese pregnant women, thereby reducing the incidence of high birthweight babies and other pregnancy complications. The Efficacy of Metformin in Pregnant Obese Women, a Randomised controlled (EMPOWaR) trial is a double-masked randomised placebo-controlled trial to determine whether metformin given to obese (body mass index >30 kg/m(2)) pregnant women from 16 weeks' gestation until delivery reduces the incidence of high birthweight babies. A secondary aim is to test the mechanism(s) of any effect. Obese women with a singleton pregnancy and normal glucose tolerance will be recruited prior to 16 weeks' gestation and prescribed study medication, metformin or placebo, to be taken until delivery. Further study visits will occur at 28 and 36 weeks' gestation for glucose tolerance testing and to record anthropometric measurements. Birth weight and other measurements will be recorded at time of delivery. Anthropometry of mother and baby will be performed at 3 months postdelivery. As of January 2014, 449 women had been randomised across the UK. The study will be conducted in accordance with the principles of Good Clinical Practice. A favourable ethical opinion was obtained from Scotland A Research Ethics Committee, reference number 10/MRE00/12. Results will be disseminated at conferences and published in peer-reviewed journals. ISRCTN51279843. Published by the BMJ Publishing Group Limited. For

  10. A multi-site randomised controlled trial of evidence-based supported employment for adults with severe and persistent mental illness.

    Science.gov (United States)

    Waghorn, Geoffrey; Dias, Shannon; Gladman, Beverley; Harris, Meredith; Saha, Sukanta

    2014-12-01

    The Individual Placement and Support (IPS) approach is an evidence-based form of supported employment for people with severe and persistent mental illness. This approach is not yet widely available in Australia even though there is mounting evidence of its generalisability outside the USA. One previous Australian randomised controlled trial found that IPS is effective for young people with first episode psychosis. The aim of the current trial was to assess the effectiveness of evidence-based supported employment when implemented for Australian adult consumers of public mental health services by utilising existing service systems. A four-site randomised control trial design (n = 208) was conducted in Brisbane (two sites), Townsville and Cairns. The intervention consisted of an IPS supported employment service hosted by a community mental health team. The control condition was delivered at each site by mental health teams referring consumers to other disability employment services in the local area. At 12 months, those in the IPS condition had 2.4 times greater odds of commencing employment than those in the control condition (42.5% vs. 23.5%). The conditions did not differ on secondary employment outcomes including job duration, hours worked, or job diversity. Attrition was higher than expected in both conditions with 28.4% completing the baseline interview but taking no further part in the study. The results support previous international findings that IPS-supported employment is more effective than non-integrated supported employment. IPS can be successfully implemented this way in Australia, but with a loss of effect strength compared to previous USA trials. © 2014 Occupational Therapy Australia.

  11. ‘Putting Life in Years’ (PLINY) telephone friendship groups research study: pilot randomised controlled trial

    Science.gov (United States)

    2014-01-01

    Background Loneliness in older people is associated with poor health-related quality of life (HRQoL). We undertook a parallel-group randomised controlled trial to evaluate the effectiveness and cost-effectiveness of telephone befriending for the maintenance of HRQoL in older people. An internal pilot tested the feasibility of the trial and intervention. Methods Participants aged >74 years, with good cognitive function, living independently in one UK city were recruited through general practices and other sources, then randomised to: (1) 6 weeks of short one-to-one telephone calls, followed by 12 weeks of group telephone calls with up to six participants, led by a trained volunteer facilitator; or (2) a control group. The main trial required the recruitment of 248 participants in a 1-year accrual window, of whom 124 were to receive telephone befriending. The pilot specified three success criteria which had to be met in order to progress the main trial to completion: recruitment of 68 participants in 95 days; retention of 80% participants at 6 months; successful delivery of telephone befriending by local franchise of national charity. The primary clinical outcome was the Short Form (36) Health Instrument (SF-36) Mental Health (MH) dimension score collected by telephone 6 months following randomisation. Results We informed 9,579 older people about the study. Seventy consenting participants were randomised to the pilot in 95 days, with 56 (80%) providing valid primary outcome data (26 intervention, 30 control). Twenty-four participants randomly allocated to the research arm actually received telephone befriending due to poor recruitment and retention of volunteer facilitators. The trial was closed early as a result. The mean 6-month SF-36 MH scores were 78 (SD 18) and 71 (SD 21) for the intervention and control groups, respectively (mean difference, 7; 95% CI, -3 to 16). Conclusions Recruitment and retention of participants to a definitive trial with a

  12. RESPIRE 1: a phase III placebo-controlled randomised trial of ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis.

    Science.gov (United States)

    De Soyza, Anthony; Aksamit, Timothy; Bandel, Tiemo-Joerg; Criollo, Margarita; Elborn, J Stuart; Operschall, Elisabeth; Polverino, Eva; Roth, Katrin; Winthrop, Kevin L; Wilson, Robert

    2018-01-01

    We evaluated the efficacy and safety of ciprofloxacin dry powder for inhalation (DPI) in patients with non-cystic fibrosis bronchiectasis, two or more exacerbations in the previous year and pre-defined bacteria in sputum.In this phase III, double-blind, placebo-controlled trial, patients were randomised 2:1 to twice-daily ciprofloxacin DPI 32.5 mg or placebo in two treatment regimens consisting of on/off treatment cycles of 14 or 28 days for 48 weeks. The primary end-points were time to first exacerbation and frequency of exacerbations.A total of 416 patients were randomised to the 14-day on/off regimen (ciprofloxacin DPI (n=137) and placebo (n=68)) or the 28-day on/off regimen (ciprofloxacin DPI (n=141) and placebo (n=70)). Ciprofloxacin DPI 14 days on/off significantly prolonged time to first exacerbation versus pooled placebo (median time >336 versus 186 days; hazard ratio 0.53, 97.5% CI 0.36-0.80; p=0.0005) and reduced the frequency of exacerbations compared with matching placebo by 39% (mean number of exacerbations 0.6 versus 1.0; incidence rate ratio 0.61, 97.5% CI 0.40-0.91; p=0.0061). Outcomes for ciprofloxacin DPI 28 days on/off were not statistically significantly different from placebo. The safety profile of ciprofloxacin DPI was favourable.Ciprofloxacin DPI was well tolerated and has the potential to be an effective treatment option in non-cystic fibrosis bronchiectasis. Copyright ©ERS 2018.

  13. Effect of Improving Dietary Quality on Arterial Stiffness in Subjects with Type 1 and Type 2 Diabetes: A 12 Months Randomised Controlled Trial

    Directory of Open Access Journals (Sweden)

    Kristina S. Petersen

    2016-06-01

    Full Text Available People with diabetes have accelerated arterial stiffening. The aim of this study was to determine the effect of increasing fruit, vegetable and dairy intake for 12 months on carotid femoral pulse wave velocity (cfPWV, augmentation index (AIx, and central blood pressure (cBP, compared to a usual diet control, in people with type 1 and type 2 diabetes. In a 12 months randomised controlled trial, cfPWV, AIx and cBP were measured every 3 months. The intervention group received dietary counselling to increase consumption of fruit (+1 serving/day; 150 g/day, vegetables (+2 servings/day; 150 g/day and dairy (+1 serving/day; 200–250 g/day at baseline, 1, 3, 6 and 9 months. The control group continued on their usual diet. One hundred and nine participants were randomised and 92 (intervention n = 45; control n = 47 completed. At 3 months, fruit (184 g/day; p = 0.001 and dairy (83 g/day; p = 0.037 intake increased in the intervention group compared with the control group but this increase was not maintained at 12 months. After adjustment for baseline measurements there was no time by treatment effect for central systolic or diastolic BP, AIx or cfPWV. A time effect existed for AIx which modestly increased over time. Peripheral diastolic BP and central pulse pressure were improved in the intervention group compared with the control group at 12 months. In the cohort with type 1 and type 2 diabetes, improving dietary quality by increasing consumption of fruit, vegetables and dairy did not improve cBP, AIx or cfPWV, compared with a control group continuing on their usual diet, after 12 months.

  14. Dental care resistance prevention and antibiotic prescribing modification-the cluster-randomised controlled DREAM trial.

    Science.gov (United States)

    Löffler, Christin; Böhmer, Femke; Hornung, Anne; Lang, Hermann; Burmeister, Ulrike; Podbielski, Andreas; Wollny, Anja; Kundt, Günther; Altiner, Attila

    2014-02-22

    Bacterial resistance development is one of the most urgent problems in healthcare worldwide. In Europe, dentistry accounts for a comparatively high amount of antibiotic prescriptions. In light of increasing levels of bacterial resistance, this development is alarming. So far, very few interventional studies have been performed, and further research is urgently needed. By means of a complex educational intervention, the DREAM trial aims at optimising antibiotic prescribing behaviour of general dentists in Germany. This is a cluster-randomised controlled trial, where each cluster consists of one dental practice and all of its patients in a defined period. Participants are general dentists practicing in the German region of Mecklenburg-Western Pomerania. Randomisation takes place after baseline data collection (6 months) and will be stratified by the antibiotic prescribing rates of the participating dental practices. Dentists randomised into the intervention group will participate in a complex small group educational seminar that aims at: increasing knowledge on bacterial resistance, pharmacology, and prophylaxis of infectious endocarditis; increasing awareness of dentist-patient communication using video-taped vignettes of dentist-patient communication on antibiotic treatment; improving collaboration between general dentists, general practitioners, and practice-based cardiologists on the necessity of antibiotic prophylaxis; enhancing awareness of the dentists' own prescribing habits by providing antibiotic prescribing feedback; and increasing patient knowledge on antibiotic treatment by providing patient-centred information material on antibiotic prophylaxis of endocarditis. The dentists randomised into the control group will not receive any educational programme and provide care as usual. Primary outcome is the overall antibiotic prescribing rate measured at T1 (period of six months after intervention). In a subgroup of adult patients affected by odontogenic

  15. Adjunctive rifampicin to reduce early mortality from Staphylococcus aureus bacteraemia (ARREST: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Thwaites Guy

    2012-12-01

    Full Text Available Abstract Background Staphylococcus aureus bacteraemia is a common and serious infection, with an associated mortality of ~25%. Once in the blood, S. aureus can disseminate to infect almost any organ, but bones, joints and heart valves are most frequently affected. Despite the infection’s severity, the evidence guiding optimal antibiotic therapy is weak: fewer than 1,500 patients have been included in 16 randomised controlled trials investigating S. aureus bacteraemia treatment. It is uncertain which antibiotics are most effective, their route of administration and duration, and whether antibiotic combinations are better than single agents. We hypothesise that adjunctive rifampicin, given in combination with a standard first-line antibiotic, will enhance killing of S. aureus early in the treatment course, sterilise infected foci and blood faster, and thereby reduce the risk of dissemination, metastatic infection and death. Our aim is to determine whether adjunctive rifampicin reduces all-cause mortality within 14 days and bacteriological failure or death within 12 weeks from randomisation. Methods We will perform a parallel group, randomised (1:1, blinded, placebo-controlled trial in NHS hospitals across the UK. Adults (≥18 years with S. aureus (meticillin-susceptible or resistant grown from at least one blood culture who have received ≤96 h of active antibiotic therapy for the current infection and do not have contraindications to the use of rifampicin will be eligible for inclusion. Participants will be randomised to adjunctive rifampicin (600-900mg/day; orally or intravenously or placebo for the first 14 days of therapy in combination with standard single-agent antibiotic therapy. The co-primary outcome measures will be all-cause mortality up to 14 days from randomisation and bacteriological failure/death (all-cause up to 12 weeks from randomisation. 940 patients will be recruited, providing >80% power to detect 45% and 30% reductions in

  16. Feather bedding and childhood asthma associated with house dust mite sensitisation : a randomised controlled trial

    NARCIS (Netherlands)

    Glasgow, Nicholas J.; Ponsonby, Anne-Louise; Kemp, Andrew; Tovey, Euan; van Asperen, Peter; McKay, Karen; Forbes, Samantha

    Introduction Observational studies report inverse associations between the use of feather upper bedding (pillow and/or quilt) and asthma symptoms but there is no randomised controlled trial (RCT) evidence assessing the role of feather upper bedding as a secondary prevention measure. Objective To

  17. Benfotiamine in diabetic polyneuropathy (BENDIP): results of a randomised, double blind, placebo-controlled clinical study.

    Science.gov (United States)

    Stracke, H; Gaus, W; Achenbach, U; Federlin, K; Bretzel, R G

    2008-11-01

    Efficacy and safety of benfotiamine in treatment of diabetic polyneuropathy. Double blind, placebo-controlled, phase-III-study. 181 patients were screened. 165 patients with symmetrical, distal diabetic polyneuropathy were randomised to one of three treatment groups entering the wash-out phase and 133/124 patients were analysed in the ITT/PP analysis: Benfotiamine 600 mg per day (n=47/43), benfotiamine 300 mg per day (n=45/42) or placebo (n=41/39). After 6 weeks of treatment, the primary outcome parameter NSS (Neuropathy Symptom Score) differed significantly between the treatment groups (p=0.033) in the PP (per protocol) population. In the ITT (intention to treat) population, the improvement of NSS was slightly above significance (p=0.055). The TSS (Total Symptom Score) showed no significant differences after 6 weeks of treatment. The improvement was more pronounced at the higher benfotiamine dose and increased with treatment duration. In the TSS, best results were obtained for the symptom "pain". Treatment was well tolerated in all groups. Benfotiamine may extend the treatment option for patients with diabetic polyneuropathy based on causal influence on impaired glucose metabolism. Further studies should confirm the positive experiences.

  18. Impact of pelvic floor muscle training on sexual function of women with urinary incontinence and a comparison of electrical stimulation versus standard treatment (IPSU trial): a randomised controlled trial.

    Science.gov (United States)

    Jha, Swati; Walters, Stephen J; Bortolami, Oscar; Dixon, Simon; Alshreef, Abualbishr

    2018-03-01

    To evaluate the clinical and cost-effectiveness of electric stimulation plus standard pelvic floor muscle training compared to standard pelvic floor muscle training alone in women with urinary incontinence and sexual dysfunction. Single centre two arm parallel group randomised controlled trial conducted in a Teaching hospital in England. Participants were women presenting with urinary incontinence and sexual dysfunction. The interventions compared were electric stimulation versus standard pelvic floor muscle training. included Prolapse and Incontinence Sexual function Questionnaire (PISQ) physical function dimension at post-treatment (primary); other dimensions of PISQ, SF-36; EQ-5D, EPAQ, resource use, adverse events and cost-effectiveness (secondary outcomes). 114 women were randomised (Intervention n=57; Control group n=57). 64/114 (56%). had valid primary outcome data at follow-up (Intervention 30; Control 34). The mean PISQ-PF dimension scores at follow-up were 33.1 (SD 5.5) and 32.3 (SD 5.2) for the Intervention and Control groups respectively; with the Control group having a higher (better) score. After adjusting for baseline score, BMI, menopausal status, time from randomisation and baseline oxford scale score the mean difference was -1.0 (95% CI: -4.0 to 1.9; P=0.474). There was no differences between the groups in any of the secondary outcomes at follow-up. Within this study, the use of electrical stimulation was cost-effective with very small incremental costs and quality adjusted life years (QALYs). In women presenting with urinary incontinence in conjunction with sexual dysfunction, physiotherapy is beneficial to improve overall sexual function. However no specific form of physiotherapy is beneficial over another. Trial registration ISRCTN09586238. Copyright © 2017 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

  19. Randomised trial of biofeedback training for encopresis

    NARCIS (Netherlands)

    van der Plas, R. N.; Benninga, M. A.; Redekop, W. K.; Taminiau, J. A.; Büller, H. A.

    1996-01-01

    To evaluate biofeedback training in children with encopresis and the effect on psychosocial function. Prospective controlled randomised study. PATIENT INTERVENTIONS: A multimodal treatment of six weeks. Children were randomised into two groups. Each group received dietary and toilet advice, enemas,

  20. The gait and balance of patients with diabetes can be improved: a randomised controlled trial.

    Science.gov (United States)

    Allet, L; Armand, S; de Bie, R A; Golay, A; Monnin, D; Aminian, K; Staal, J B; de Bruin, E D

    2010-03-01

    Gait characteristics and balance are altered in diabetic patients. Little is known about possible treatment strategies. This study evaluates the effect of a specific training programme on gait and balance of diabetic patients. This was a randomised controlled trial (n=71) with an intervention (n=35) and control group (n=36). The intervention consisted of physiotherapeutic group training including gait and balance exercises with function-orientated strengthening (twice weekly over 12 weeks). Controls received no treatment. Individuals were allocated to the groups in a central office. Gait, balance, fear of falls, muscle strength and joint mobility were measured at baseline, after intervention and at 6-month follow-up. The trial is closed to recruitment and follow-up. After training, the intervention group increased habitual walking speed by 0.149 m/s (pbalance (time to walk over a beam, balance index recorded on Biodex balance system), their performance-oriented mobility, their degree of concern about falling, their hip and ankle plantar flexor strength, and their hip flexion mobility compared with the control group. After 6 months, all these variables remained significant except for the Biodex sway index and ankle plantar flexor strength. Two patients developed pain in their Achilles tendon: the progression for two related exercises was slowed down. Specific training can improve gait speed, balance, muscle strength and joint mobility in diabetic patients. Further studies are needed to explore the influence of these improvements on the number of reported falls, patients' physical activity levels and quality of life. ClinicalTrials.gov NCT00637546 This work was supported by the Swiss National Foundation (SNF): PBSKP-123446/1/

  1. Aladağlar’da [Orta Toroslar (Yahyalı-Kayseri)] iki fosil mağara: Zindan-ı Köşk–1 ve Zindan-ı Köşk-2 mağaraları

    OpenAIRE

    Kopar, İbrahim

    2015-01-01

    Zindan-ı Köşk-1 ve Zindan-ı Köşk-2 Mağaraları, jeomorfolojik olarak Toros Dağları’nın Orta Toros Bölümü’nün doğusundaki Aladağlarda (en yüksek tepesi 3756 m) yer almaktadır. İdari bakımdan ise Kayseri İlinin Yahyalı ilçesi sınırlarında yer alan mağaralar, naplı yapıya sahip Permiyen kalkerler içinde gelişmiştir. Zindan Deresi’nin 500 metreden fazla yardığı adinin güney yamacında 2095 m ve 2115 metrede giriş ağızları olan mağaralardan üstteki Zindan-ı Köşk-1 Mağarası dikey gelişmiş bir mağara ...

  2. A randomised controlled trial in comparing maternal and neonatal outcomes between hands-and-knees delivery position and supine position in China.

    Science.gov (United States)

    Zhang, Hongyu; Huang, Shurong; Guo, Xiaolan; Zhao, Ningning; Lu, Yujing; Chen, Min; Li, Yingxia; Wu, Junqin; Huang, Lihua; Ma, Fenglan; Yang, Yuhong; Zhang, Xiaoli; Zhou, Xiaoyu; Guo, Renfei; Cai, Wenzhi

    2017-07-01

    the supine position is the most frequently offered for birth delivery in China and many other countries, but the hands-and-knees position is now gaining prominence with doctors in China. This study aims to examine the differences in maternal and neonatal outcomes among low-risk women who gave birth either in the hands-and-knees position or the supine position. a randomised controlled trial was conducted in 11 hospitals in China from May to December in 2012. In total, 1400 women were recruited and randomly allocated to either the experimental group (n=700, 446 completed the protocol) who delivered in hands-and-knees position and the control group (n=700, 440 completed the protocol) who delivered in supine position. Women who could not maintain the randomised position during the second stage of labour were allowed to withdraw from the study. The primary maternal outcome measured was rate of episiotomy. Secondary outcomes included degree of perineum laceration, rate of emergency caesarean section, rate of shoulder dystocia, and duration of labour, postpartum bleeding, neonatal Apgar score, and the rate of neonatal asphyxia. Because outcome data were only collected for women who gave birth in the randomised position, per-protocol analyses were used to compare groups. The primary outcome, episiotomy, was also compared between groups using logistic regression adjusting for maternal age,gestational age at birth, whether the woman was primiparous, the process of second stage of labour and birthweight. as compared with the control group, the experimental group had lower rates of episiotomy and second-degree perineum laceration (including episiotomy), and higher rates of intact perineum and first-degree perineum laceration, with a longer duration of second stage of labour. No significant differences were found in the amount of postpartum bleeding, shoulder dystocia, neonatal asphyxia and neonatal Apgar scores at 1minute and 5minutes. Adjusted for maternal age, gestational

  3. Surgical excision versus imiquimod 5% cream for nodular and superficial basal-cell carcinoma (SINS): a multicentre, non-inferiority, randomised controlled trial.

    Science.gov (United States)

    Bath-Hextall, Fiona; Ozolins, Mara; Armstrong, Sarah J; Colver, Graham B; Perkins, William; Miller, Paul S J; Williams, Hywel C

    2014-01-01

    Basal-cell carcinoma is the most common form of skin cancer and its incidence is increasing worldwide. We aimed to assess the effectiveness of imiquimod cream versus surgical excision in patients with low-risk basal-cell carcinoma. We did a multicentre, parallel-group, pragmatic, non-inferiority, randomised controlled trial at 12 centres in the UK, in which patients were recruited between June 19, 2003, and Feb 22, 2007, with 3 year follow-up from June 26, 2006, to May 26, 2010. Participants of any age were eligible if they had histologically confirmed primary nodular or superficial basal-cell carcinoma at low-risk sites. We excluded patients with morphoeic or recurrent basal-cell carcinoma and those with Gorlin syndrome. Participants were randomly assigned (1:1) via computer-generated blocked randomisation, stratified by centre and tumour type, to receive either imiquimod 5% cream once daily for 6 weeks (superficial) or 12 weeks (nodular), or surgical excision with a 4 mm margin. The randomisation sequence was concealed from study investigators. Because of the nature of the interventions, masking of participants was not possible and masking of outcome assessors was only partly possible. The trial statistician was masked to allocation until all analyses had been done. The primary outcome was the proportion of participants with clinical success, defined as absence of initial treatment failure or signs of recurrence at 3 years from start of treatment. We used a prespecified non-inferiority margin of a relative risk (RR) of 0.87. Analysis was by a modified intention-to-treat population and per protocol. This study is registered as an International Standard Randomised Controlled Trial (ISRCTN48755084), and with ClinicalTrials.gov, number NCT00066872. 501 participants were randomly assigned to the imiquimod group (n=254) or the surgical excision group (n=247). At year 3, 401 (80%) patients were included in the modified intention-to-treat group. At 3 years, 178 (84%) of

  4. A randomised group comparison controlled trial of 'preschoolers with autism': a parent education and skills training intervention for young children with autistic disorder.

    Science.gov (United States)

    Tonge, Bruce; Brereton, Avril; Kiomall, Melissa; Mackinnon, Andrew; Rinehart, Nicole J

    2014-02-01

    To determine the effect of parent education on adaptive behaviour, autism symptoms and cognitive/language skills of young children with autistic disorder. A randomised group comparison design involving a parent education and counselling intervention and a parent education and behaviour management intervention to control for parent skills training and a control sample. Two rural and two metropolitan regions were randomly allocated to intervention groups (n = 70) or control (n = 35). Parents from autism assessment services in the intervention regions were randomly allocated to parent education and behaviour management (n = 35) or parent education and counselling (n = 35). Parent education and behaviour management resulted in significant improvement in adaptive behaviour and autism symptoms at 6 months follow-up for children with greater delays in adaptive behaviour. Parent education and behaviour management was superior to parent education and counselling. We conclude that a 20-week parent education programme including skills training for parents of young children with autistic disorder provides significant improvements in child adaptive behaviour and symptoms of autism for low-functioning children.

  5. Accrual and drop out in a primary prevention randomised controlled trial: qualitative study

    Directory of Open Access Journals (Sweden)

    Price Jackie F

    2011-01-01

    Full Text Available Abstract Background Recruitment and retention of participants are critical to the success of a randomised controlled trial. Gaining the views of potential trial participants who decline to enter a trial and of trial participants who stop the trial treatment is important and can help to improve study processes. Limited research on these issues has been conducted on healthy individuals recruited for prevention trials in the community. Methods Semi-structured interviews with people who were eligible but had declined to participate in the Aspirin for Asymptomatic Atherosclerosis (AAA trial (N = 11, and AAA trial participants who had stopped taking the trial medication (N = 11. A focus group with further participants who had stopped taking the trial medication (N = 6. (Total participants N = 28. Results Explanations for declining to participate could be divided into two groups: the first group were characterised by a lack of necessity to participate and a tendency to prioritise other largely mundane problems. The second group's concern was with a high level of perceived risk from participating. Explanations for stopping trial medication fell into four categories: side effects attributed to the trial medication; starting on aspirin or medication contraindicating to aspirin; experiencing an outcome event, and changing one's mind. Conclusions These results indicate that when planning trials (especially in preventive medicine particular attention should be given to designing appropriate recruitment materials and processes that fully inform potential recruits of the risks and benefits of participation. Trial registration ISRCTN66587262

  6. Accrual and drop out in a primary prevention randomised controlled trial: qualitative study.

    Science.gov (United States)

    Eborall, Helen C; Stewart, Marlene C W; Cunningham-Burley, Sarah; Price, Jackie F; Fowkes, F Gerry R

    2011-01-11

    Recruitment and retention of participants are critical to the success of a randomised controlled trial. Gaining the views of potential trial participants who decline to enter a trial and of trial participants who stop the trial treatment is important and can help to improve study processes. Limited research on these issues has been conducted on healthy individuals recruited for prevention trials in the community. Semi-structured interviews with people who were eligible but had declined to participate in the Aspirin for Asymptomatic Atherosclerosis (AAA) trial (N = 11), and AAA trial participants who had stopped taking the trial medication (N = 11). A focus group with further participants who had stopped taking the trial medication (N = 6). (Total participants N = 28). Explanations for declining to participate could be divided into two groups: the first group were characterised by a lack of necessity to participate and a tendency to prioritise other largely mundane problems. The second group's concern was with a high level of perceived risk from participating.Explanations for stopping trial medication fell into four categories: side effects attributed to the trial medication; starting on aspirin or medication contraindicating to aspirin; experiencing an outcome event, and changing one's mind. These results indicate that when planning trials (especially in preventive medicine) particular attention should be given to designing appropriate recruitment materials and processes that fully inform potential recruits of the risks and benefits of participation. ISRCTN66587262.

  7. Effect of a 16-week Bikram yoga program on perceived stress, self-efficacy and health-related quality of life in stressed and sedentary adults: A randomised controlled trial.

    Science.gov (United States)

    Hewett, Zoe L; Pumpa, Kate L; Smith, Caroline A; Fahey, Paul P; Cheema, Birinder S

    2018-04-01

    The purpose of this study was to investigate the effect of 16 weeks of Bikram yoga on perceived stress, self-efficacy and health related quality of life (HRQoL) in sedentary, stressed adults. 16 week, parallel-arm, randomised controlled trial with flexible dosing. Physically inactive, stressed adults (37.2±10.8 years) were randomised to Bikram yoga (three to five classes per week) or control (no treatment) group for 16 weeks. Outcome measures, collected via self-report, included perceived stress, general self-efficacy, and HRQoL. Outcomes were assessed at baseline, midpoint and completion. Individuals were randomised to the experimental (n=29) or control group (n=34). Average attendance in the experimental group was 27±18 classes. Repeated measure analyses of variance (intention-to-treat) demonstrated significantly improved perceived stress (p=0.003, partial η 2 =0.109), general self-efficacy (p=0.034, partial η 2 =0.056), and the general health (p=0.034, partial η 2 =0.058) and energy/fatigue (p=0.019, partial η 2 =0.066) domains of HRQoL in the experimental group versus the control group. Attendance was significantly associated with reductions in perceived stress, and an increase in several domains of HRQoL. 16 weeks of Bikram yoga significantly improved perceived stress, general self-efficacy and HRQoL in sedentary, stressed adults. Future research should consider ways to optimise adherence, and should investigate effects of Bikram yoga intervention in other populations at risk for stress-related illness. Australia New Zealand Clinical Trials Registry ACTRN12616000867493. Registered 04 July 2016. URL: http://www.anzctr.org.au/ACTRN12616000867493.aspx. Copyright © 2017 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

  8. 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

    is a protocol for a randomised trial, the findings of which will contribute information about the optimal time of birth for women with an uncomplicated multiple pregnancy at and beyond 37 weeks gestation. Clinical Trial Registration Current Controlled Trials ISRCTN15761056

  9. Reliable implementation of intelligent load control and decentralized power generation in the E-Energy project E-DeMa; Zuverlaessige Integration intelligenter Laststeuerung und dezentraler Energieerzeugung im E-Energy Projekt E-DeMa

    Energy Technology Data Exchange (ETDEWEB)

    Langhammer, N.; Kays, R. [Technische Univ. Dortmund (Germany). Lehrstuhl fuer Kommunikationstechnik; Mueller, C.; Wietfeld, C. [Technische Univ. Dortmund (Germany). Lehrstuhl fuer Kommunikationsnetze; Kreutz, S.; Belitz, H.J.; Koenig, D.; Rehtanz, C. [Technische Univ. Dortmund (Germany). Inst. fuer Energiesysteme, Energieeffizienz und Energiewirtschaft

    2012-07-01

    The authors of the contribution under consideration report on the integration of intelligent load control and distributed power producers into future smart grid energy systems. The authors present the approaches and innovations that have been developed in the framework of the E-Energy project E-DeMa. The focus of this paper is on the implementation of a communication infrastructure that has been built up in E-DeMa in a large-scale field test in two pilot regions and is currently being tested. Furthermore, the economic potential of the so-called aggregator is presented that summarizes a variety of loads in the retail sector in and intelligently controls remotely.

  10. Transabdominal amnioinfusion in preterm premature rupture of membranes: a randomised controlled trial.

    Science.gov (United States)

    Tranquilli, Andrea Luigi; Giannubilo, Stefano Raffaele; Bezzeccheri, Valeria; Scagnoli, Caterina

    2005-06-01

    To evaluate the role of transabdominal amnioinfusion in improving the perinatal outcomes of pregnancies complicated by preterm premature rupture of membranes (pPROM). A randomised controlled trial. A teaching hospital in Italy, obstetric unit. Population Women with singleton pregnancies complicated by pPROM, between 24 + 0 and 32 + 6 weeks of gestation. Patients were randomised 24 hours after admission to our referral hospital, to expectant management with transabdominal amnioinfusion or expectant management only. The effects of transabdominal amnioinfusion on pPROM-delivery interval and on perinatal outcomes. Of the 65 women with pPROM 34 met the inclusion criteria. Seventeen women were assigned to amnioinfusion (the amnioinfusion group) and the other 17 to expectant management. Compared with the control group (median: 8 days; range: 3-14), the pPROM-delivery period was significantly longer in women who underwent amnioinfusion (median: 21 days; range: 15-29) (P amnioinfusion were less likely to deliver within seven days since pPROM (RR: 0.18; range: 0.04-0.69 95% CI) or within two weeks (RR: 0.46; range: 0.21-1.02 95% CI). In the amnioinfusion group the neonatal survival was significantly higher at each gestational age (P amnioinfusion after pPROM resulted in significant prolongation of pregnancy and better neonatal outcomes.

  11. GP-initiated preconception counselling in a randomised controlled trial does not induce anxiety

    Directory of Open Access Journals (Sweden)

    Neven A Knuistingh

    2006-11-01

    Full Text Available Abstract Background Preconception counselling (PCC can reduce adverse pregnancy outcome by addressing risk factors prior to pregnancy. This study explores whether anxiety is induced in women either by the offer of PCC or by participation with GP-initiated PCC. Methods Randomised trial of usual care versus GP-initiated PCC for women aged 18–40, in 54 GP practices in the Netherlands. Women completed the six-item Spielberger State Trait Anxiety Inventory (STAI before PCC (STAI-1 and after (STAI-2. After pregnancy women completed a STAI focusing on the first trimester of pregnancy (STAI-3. Results The mean STAI-1-score (n = 466 was 36.4 (95% CI 35.4 – 37.3. Following PCC there was an average decrease of 3.6 points in anxiety-levels (95% CI, 2.4 – 4.8. Mean scores of the STAI-3 were 38.5 (95% CI 37.7 – 39.3 in the control group (n = 1090 and 38.7 (95% CI 37.9 – 39.5 in the intervention group (n = 1186. Conclusion PCC from one's own GP reduced anxiety after participation, without leading to an increase in anxiety among the intervention group during pregnancy. We therefore conclude that GPs can offer PCC to the general population without fear of causing anxiety. Trial Registration: ISRCTN53942912

  12. Desuniformidad de distribución espacial: caracterización de su impacto sobre el rendimiento de maíz (Zea mays L.)

    OpenAIRE

    D'Amico, Juan Pablo

    2012-01-01

    Una adecuada labor de siembra se define como aquella donde la diferencia entre la cantidad de plantas posibles de obtener y las emergidas es mínima, la separación entre ellas es uniforme y el tiempo transcurrido para emerger es el mínimo para el conjunto de la población (Maroni y Gargicevich 1998). En cultivos de escarda como el maíz se utilizan sembradoras de precisión, también denominadas monograno (Baumer 1999). Con estos equipos el logro de una adecuada población, bien distribuida, está a...

  13. Prenatal vitamin d supplementation and child respiratory health: a randomised controlled trial.

    Science.gov (United States)

    Goldring, Stephen T; Griffiths, Chris J; Martineau, Adrian R; Robinson, Stephen; Yu, Christina; Poulton, Sheree; Kirkby, Jane C; Stocks, Janet; Hooper, Richard; Shaheen, Seif O; Warner, John O; Boyle, Robert J

    2013-01-01

    Observational studies suggest high prenatal vitamin D intake may be associated with reduced childhood wheezing. We examined the effect of prenatal vitamin D on childhood wheezing in an interventional study. We randomised 180 pregnant women at 27 weeks gestation to either no vitamin D, 800 IU ergocalciferol daily until delivery or single oral bolus of 200,000 IU cholecalciferol, in an ethnically stratified, randomised controlled trial. Supplementation improved but did not optimise vitamin D status. Researchers blind to allocation assessed offspring at 3 years. Primary outcome was any history of wheeze assessed by validated questionnaire. Secondary outcomes included atopy, respiratory infection, impulse oscillometry and exhaled nitric oxide. Primary analyses used logistic and linear regression. We evaluated 158 of 180 (88%) offspring at age 3 years for the primary outcome. Atopy was assessed by skin test for 95 children (53%), serum IgE for 86 (48%), exhaled nitric oxide for 62 (34%) and impulse oscillometry of acceptable quality for 51 (28%). We found no difference between supplemented and control groups in risk of wheeze [no vitamin D: 14/50 (28%); any vitamin D: 26/108 (24%) (risk ratio 0.86; 95% confidence interval 0.49, 1.50; P = 0.69)]. There was no significant difference in atopy, eczema risk, lung function or exhaled nitric oxide between supplemented groups and controls. Prenatal vitamin D supplementation in late pregnancy that had a modest effect on cord blood vitamin D level, was not associated with decreased wheezing in offspring at age three years. Controlled-Trials.com ISRCTN68645785.

  14. A Randomised Controlled Trial of a Play-Based Intervention to Improve the Social Play Skills of Children with Attention Deficit Hyperactivity Disorder (ADHD)

    Science.gov (United States)

    Wilkes-Gillan, Sarah; Lincoln, Michelle; Chen, Yu-Wei

    2016-01-01

    There is a need for effective interventions to address the social difficulties of children with ADHD. This randomised controlled trial examined the effectiveness of a play-based intervention for improving the social play skills of children with ADHD in peer-to-peer interactions. Children with ADHD (5 to 11 years) were randomised to an intervention-first (n = 15) or waitlist control-first group (n = 14). Participants allocated to the control-first group received the intervention after a 10-week wait period. Children invited a typically-developing playmate and parents of children with ADHD participated. The intervention involved: six clinic play-sessions, weekly home-modules and a one-month home follow up. The Test of Playfulness (ToP) was scored by a blinded rater. Parent reported treatment adherence was used to assess treatment fidelity. Between group statistics were used to compare the change of the intervention-first (10-week intervention period) and control-first (10-week wait period) groups. Once all children had received the intervention, repeated measures ANOVA, post hoc Least Significance Difference tests and Cohen’s-d were used to measure effect. Changes in ToP social items were analysed using Friedman’s ANOVA. Linear regression analyses were used to identify variables that predicted change. The control-first group did not change during the wait period. The change in the intervention-first group was significantly greater than the change in the control-first group (during the wait period). When the data from the two groups were combined, the mean ToP scores of the children with ADHD (n = 29) improved significantly following the intervention, with a large effect from pre to post intervention and from pre intervention to follow up. Children maintained treatment gains at follow up. All ToP social items improved significantly following the intervention. The findings support the use of play involving parent and peer mediated components to enhance the social

  15. A Randomised Controlled Trial of a Play-Based Intervention to Improve the Social Play Skills of Children with Attention Deficit Hyperactivity Disorder (ADHD).

    Science.gov (United States)

    Wilkes-Gillan, Sarah; Bundy, Anita; Cordier, Reinie; Lincoln, Michelle; Chen, Yu-Wei

    2016-01-01

    There is a need for effective interventions to address the social difficulties of children with ADHD. This randomised controlled trial examined the effectiveness of a play-based intervention for improving the social play skills of children with ADHD in peer-to-peer interactions. Children with ADHD (5 to 11 years) were randomised to an intervention-first (n = 15) or waitlist control-first group (n = 14). Participants allocated to the control-first group received the intervention after a 10-week wait period. Children invited a typically-developing playmate and parents of children with ADHD participated. The intervention involved: six clinic play-sessions, weekly home-modules and a one-month home follow up. The Test of Playfulness (ToP) was scored by a blinded rater. Parent reported treatment adherence was used to assess treatment fidelity. Between group statistics were used to compare the change of the intervention-first (10-week intervention period) and control-first (10-week wait period) groups. Once all children had received the intervention, repeated measures ANOVA, post hoc Least Significance Difference tests and Cohen's-d were used to measure effect. Changes in ToP social items were analysed using Friedman's ANOVA. Linear regression analyses were used to identify variables that predicted change. The control-first group did not change during the wait period. The change in the intervention-first group was significantly greater than the change in the control-first group (during the wait period). When the data from the two groups were combined, the mean ToP scores of the children with ADHD (n = 29) improved significantly following the intervention, with a large effect from pre to post intervention and from pre intervention to follow up. Children maintained treatment gains at follow up. All ToP social items improved significantly following the intervention. The findings support the use of play involving parent and peer mediated components to enhance the social play

  16. Effect of obstetric team training on team performance and medical technical skills: a randomised controlled trial

    NARCIS (Netherlands)

    Fransen, A.F.; Ven, van de J.; Merién, A.E.R.; Wit-Zuurendonk, de L.D.; Houterman, S.; Mol, B.W.J.; Oei, S.G.

    2012-01-01

    Objective To determine whether obstetric team training in a medical simulation centre improves the team performance and utilisation of appropriate medical technical skills of healthcare professionals. Design Cluster randomised controlled trial. Setting The Netherlands. Sample The obstetric

  17. Ma(d)skulinitet

    DEFF Research Database (Denmark)

    Leer, Jonatan

    Når tv-kokke som Jamie Oliver, Gordon Ramsay og brødrene Price toner frem på skærmen, laver de ikke kun mad. De mixer også maskulinitet. For når en mand laver mad, laver maden også manden. Det mener postdoc Jonatan Leer, der i Ma(ds)kulinitet. Kønskamp i tv-køkkenet præsenterer, hvordan og hvorfor...

  18. Obtención de biodiesel con aceite de maíz usado en frituras y metacaolinita como catalizador Obtención de biodiesel con aceite de maíz usado en frituras y metacaolinita como catalizador

    Directory of Open Access Journals (Sweden)

    Jorge Medina-Valtierra

    2012-02-01

    Full Text Available Se investigó la producción de biodiesel usando un reactor intermitente, se utilizó la metacaolinita como un catalizador sólido ácido que presentó una alta actividad para la pro­ducción de biodiesel a partir de aceite de maíz usado en freidora. El área superficial de la metacaolinita, diámetro de poro y volumen de poro fueron 10 m2/g, 13.0 nm y 30 mm3/g, respectivamente. Las condiciones óptimas para la reacción de transesterificación fueron: una relación molar aceite/metanol 1:31, temperatura de 160 ºC, presión manométrica de 1.65 MPa y una cantidad de catalizador de 3 (% peso. El rendimiento de ésteres metílicos de ácidos grasos (biodiesel fue de 92.4 % para 2 h de reacción. Este método de preparación de biodiesel puede ser una buena alternativa para la utilización de aceite de maíz usado en freidora como una fuente muy barata para la producción de biodiesel combinado con un catalizador barato y además amigable con el medio ambiente.Biodiesel production with used frying corn oil by transesterification reaction, with methanol, using a commercial kaolinite thermally-activated solid acid catalyst was investigated. The surface area, the average pore diameter and volume of pore of metakaolinite were 10 m2/g, 13.0 nm and 30 mm3/g, respectively. The optimal conditions for the transesterification reaction were determinate to be oil/methanol, in a molar ratio 1:31, temperature 160 ºC, manometer pressure of 1.65 MPa and catalyst concentration of 3 % (w/w. The yield of fatty acid methyl esters (biodiesel was 92.4 % after 2 h of reaction. This method of preparation of biodiesel can be a positive alternative for utilizing used frying corn oil for feedstock of biodiesel combined with the cited inexpensive, “green” catalyst.

  19. Maternal Fish Oil Supplementation in Pregnancy: A 12 Year Follow-Up of a Randomised Controlled Trial

    Directory of Open Access Journals (Sweden)

    Suzanne Meldrum

    2015-03-01

    Full Text Available A number of trials have been undertaken to assess whether the intake of omega-3 long-chain polyunsaturated fatty acids (n-3 LCPUFA during pregnancy can influence the neurological development of the offspring, yet no consensus from these trials has been reached. We aimed to investigate the long-term effects (12 years of fish oil supplementation in pregnancy on neurodevelopment, including cognition, language and fine motor skills. In a follow up of a previously published randomised controlled trial of 98 pregnant women, their children were assessed at 12 years of age using a battery of neurodevelopmental assessments. Fifty participants were assessed at 12 years, with 25 participant’s mothers receiving fish oil supplementation, and 25 receiving control capsules. There were no significant differences for any of the assessment measures completed. Our data indicate that fish oil supplementation during pregnancy does not influence the cognition, language or fine motor skills of children in late primary school (12 years of age.

  20. Maternal fish oil supplementation in pregnancy: a 12 year follow-up of a randomised controlled trial.

    Science.gov (United States)

    Meldrum, Suzanne; Dunstan, Janet A; Foster, Jonathan K; Simmer, Karen; Prescott, Susan L

    2015-03-20

    A number of trials have been undertaken to assess whether the intake of omega-3 long-chain polyunsaturated fatty acids (n-3 LCPUFA) during pregnancy can influence the neurological development of the offspring, yet no consensus from these trials has been reached. We aimed to investigate the long-term effects (12 years) of fish oil supplementation in pregnancy on neurodevelopment, including cognition, language and fine motor skills. In a follow up of a previously published randomised controlled trial of 98 pregnant women, their children were assessed at 12 years of age using a battery of neurodevelopmental assessments. Fifty participants were assessed at 12 years, with 25 participant's mothers receiving fish oil supplementation, and 25 receiving control capsules. There were no significant differences for any of the assessment measures completed. Our data indicate that fish oil supplementation during pregnancy does not influence the cognition, language or fine motor skills of children in late primary school (12 years of age).

  1. Aileler, Öğretmenler ve Dil ve Konuşma Terapistlerinin Çocuklardaki Dil ve Konuşma Bozukluklarına Yönelik Tutum ve Bilgilerinin Değerlendirilmesi

    Directory of Open Access Journals (Sweden)

    Bülent TOĞRAM

    2015-12-01

    Full Text Available Çocuklardaki iletişim sorunları aile bildirimleri, öğretmen raporları ve dil ve konuşma terapistleri (DKT tarafından yapılan değerlendirmeler ile saptanmaktadır. Dil ve konuşma bozukluklarının önlenmesi ve terapisinde işbirliği içinde bulunmaları gereken bu üçlü grubun konuya ilişkin görüş ve tutumları alanyazında önemli bulunmaktadır. Bu çalışmanın amacı, ebeveynlerin, öğretmenlerin ve DKT’lerin dil ve konuşma bozuklukları alanındaki sorumluluk ve rollerini nasıl algıladıklarını, dil ve konuşma bozukluğu olan çocuğun akademik ve sosyal başarısına yönelik tutumlarını, dil ve konuşma bozukluklarının nedenleri ve terapisine yönelik düşüncelerini betimlemektir. Çalışmaya 37 aile bireyi, 46 öğretmen ve 35 DKT katılmıştır. Anket yoluyla elde edilen veriler her grubun konuya ilişkin bilgisini ortaya koymak için karşılaştırılmıştır. Dil ve konuşma bozukluğu olan çocukların akademik/sosyal başarılarına yönelik tutumlarında diğer katılımcı gruplara göre öğretmenlerin, çocukların terapi gereksinimlerine yönelik tutumlarında ise ailelerin daha kararsız tutumlar geliştirdikleri dikkat çekmektedir.Dil ve konuşma bozukluklarının nedenleri ve terapi eksikliklerine yönelik bilgilerinde grupların öncelikli sıralamalarının farklılaştığı görülmüştür

  2. Combining escitalopram and cognitive-behavioural therapy for social anxiety disorder: randomised controlled fMRI trial.

    Science.gov (United States)

    Gingnell, Malin; Frick, Andreas; Engman, Jonas; Alaie, Iman; Björkstrand, Johannes; Faria, Vanda; Carlbring, Per; Andersson, Gerhard; Reis, Margareta; Larsson, Elna-Marie; Wahlstedt, Kurt; Fredrikson, Mats; Furmark, Tomas

    2016-09-01

    Selective serotonin reuptake inhibitors (SSRIs) and cognitive-behavioural therapy (CBT) are often used concomitantly to treat social anxiety disorder (SAD), but few studies have examined the effect of this combination. To evaluate whether adding escitalopram to internet-delivered CBT (ICBT) improves clinical outcome and alters brain reactivity and connectivity in SAD. Double-blind, randomised, placebo-controlled neuroimaging trial of ICBT combined either with escitalopram (n = 24) or placebo (n = 24), including a 15-month clinical follow-up (trial registration: ISRCTN24929928). Escitalopram+ICBT, relative to placebo+ICBT, resulted in significantly more clinical responders, larger reductions in anticipatory speech state anxiety at post-treatment and larger reductions in social anxiety symptom severity at 15-month follow-up and at a trend-level (P = 0.09) at post-treatment. Right amygdala reactivity to emotional faces also decreased more in the escitalopram+ICBT combination relative to placebo+ICBT, and in treatment responders relative to non-responders. Adding escitalopram improves the outcome of ICBT for SAD and decreased amygdala reactivity is important for anxiolytic treatment response. © The Royal College of Psychiatrists 2016.

  3. Protocol for a Cluster Randomised Controlled Trial to Compare the “Taste & See” Programme—A Church-Based Programme to Develop a Healthy Relationship with Food—With a Wait-List Control

    Directory of Open Access Journals (Sweden)

    Deborah Lycett

    2018-03-01

    Full Text Available (1 Background: Obesity is strongly associated with poor mental-health. Spiritual and religious wellbeing is associated with improved mental well-being and reduced emotional eating. “Taste & See”, a church based programme to help develop a healthy relationship with food has been successfully tested for feasibility in the UK but an adequately powered randomised controlled trial is needed to test efficacy. This paper reports on the protocol for such a trial; (2 Method: A cluster, randomised controlled trial where Christian churches (any denomination are the unit of randomisation. 150 overweight adults will be recruited from approximately 15 churches (clusters in the UK, each church (cluster will recruit approximately 10 participants. Churches will be randomised 2:1 to either begin the “Taste & See” programme immediately or in 10 weeks’ time. Data on eating habits, mental and spiritual health will be collected online before and after the intervention and control period and follow-up will continue until 2 years; (3 Implication of Results: Should the programme prove effective it will provide strong clinical evidence of the role of churches in improving the health and well-being of those struggling with food and weight issues.

  4. Un método de transformación genética de maíz para conferirle resistencia ulterior a enfermedades virales

    OpenAIRE

    Valdez, Marta; Madriz, Kenneth; Ramírez, Pilar

    2004-01-01

    Se desarrolló un sistema de transformación genética para dos variedades costarricenses de maíz: CR-7 y Diamantes 8843, que permita la transferencia ulterior de genes de origen viral a su genoma, y conferirles resistencia a la enfermedad ocasionada por el virus del rayado fino del maíz (MRFV). El método se basa en el bombardeo de microproyectiles en callos organogénicos derivados de ápices de jóvenes vitrogerminaciones. Por otro lado, se elaboró la construcción molecular pRFcp-bar que contiene...

  5. Adherence therapy improves medication adherence and quality of life in people with Parkinson's disease: a randomised controlled trial.

    Science.gov (United States)

    Daley, D J; Deane, K H O; Gray, R J; Clark, A B; Pfeil, M; Sabanathan, K; Worth, P F; Myint, P K

    2014-08-01

    Many factors are associated with medication non-adherence in Parkinson's disease (PD), including complex treatment regimens, mood disorders and impaired cognition. However, interventions to improve adherence which acknowledge such factors are lacking. A phase II randomised controlled trial was conducted investigating whether Adherence Therapy (AT) improves medication adherence and quality of life (QoL) compared with routine care (RC) in PD. Eligible PD patients and their spouse/carers were randomised to intervention (RC plus AT) or control (RC alone). Primary outcomes were change in adherence (Morisky Medication Adherence Scale) and QoL (Parkinson's Disease Questionnaire-39) from baseline to week-12 follow up. Secondary outcomes were MDS-UPDRS (part I, II, IV), Beliefs about Medication Questionnaire (BMQ), EuroQol (EQ-5D) and the Caregiving Distress Scale. Blinded data were analysed using logistic and linear regression models based on the intention-to-treat principle. Seventy-six patients and 46 spouse/carers completed the study (intervention: n = 38 patients, n = 24 spouse/carers). At week-12 AT significantly improved adherence compared with RC (OR 8.2; 95% CI: 2.8, 24.3). Numbers needed to treat (NNT) were 2.2 (CI: 1.6, 3.9). Compared with RC, AT significantly improved PDQ-39 (-9.0 CI: -12.2, -5.8), BMQ general harm (-1.0 CI: -1.9, -0.2) and MDS-UPDRS part II (-4.8 CI: -8.1, -1.4). No significant interaction was observed between the presence of a spouse/carer and the effect of AT. Adherence Therapy improved self-reported adherence and QoL in a PD sample. The small NNT suggests AT may be cost-effective. A larger pragmatic trial to test the efficacy and cost-effectiveness of AT by multiple therapists is required. © 2014 John Wiley & Sons Ltd.

  6. The impact of electronic education on metabolic control indicators in patients with diabetes who need insulin: a randomised clinical control trial.

    Science.gov (United States)

    Moattari, Marzieh; Hashemi, Maryam; Dabbaghmanesh, Mohammad H

    2013-01-01

    To determine the impact of electronic education on metabolic control indicators in patients with diabetes who were insulin dependent. Education can play an important role in controlling diabetes. Electronic (web-based, telehealth) education may be an efficient way to improve the patients' ability to control this disease. Randomised clinical control study. The participants in this clinical study were 48 insulin-dependent patients referred to diabetes centres in Shiraz, Iran. Serum concentrations of haemoglobin A(1C) , fasting blood sugar, triglycerides and high-density and low-density lipoprotein cholesterol were measured. Then the participants were divided randomly into control and experimental groups (n = 24). Participants in the experimental group received a specially designed electronic education programme for twelve weeks. The main components of the programme were a consultation service, quick answers to patients' questions, contact with the healthcare team and educational materials. At the end of the intervention period, all serum values were measured again in both groups. The data were compared using spss v 13·5 software. Serum concentrations of haemoglobin A(1C) (p education programme was useful in lowering two metabolic indicators of diabetes. Electronic education can be associated with increased health and patient satisfaction, and can eliminate the need to train personnel. © 2012 Blackwell Publishing Ltd.

  7. Tailored online cognitive behavioural therapy with or without therapist support calls to target psychological distress in adults receiving haemodialysis: A feasibility randomised controlled trial.

    Science.gov (United States)

    Hudson, Joanna L; Moss-Morris, Rona; Norton, Sam; Picariello, Federica; Game, David; Carroll, Amy; Spencer, Jonathan; McCrone, Paul; Hotopf, Matthew; Yardley, Lucy; Chilcot, Joseph

    2017-11-01

    Psychological distress is prevalent in haemodialysis (HD) patients yet access to psychotherapy remains limited. This study assessed the feasibility and acceptability of online cognitive-behavioural therapy (CBT) tailored for HD patients, with or without therapist support, for managing psychological distress. This feasibility randomised controlled trial recruited patients from a UK HD centre. Following psychological distress screens, patients with mild-moderate psychological distress (Patient Health Questionnaire PHQ-9; score: 5-19 and/or Generalised Anxiety Disorder; GAD-7 score: 5-14) who met remaining inclusion criteria were approached for consent. Consenters were individually randomised (1:1) to online-CBT or online-CBT plus three therapist support calls. Outcomes included recruitment, retention, and adherence rates. Exploratory change analyses were performed for: psychological distress, quality of life (QoL), illness perceptions, and costs. The statistician was blinded to allocation. 182 (44%) out of 410 patients approached completed psychological distress screens. 26% found screening unacceptable; a further 30% found it unfeasible. Psychological distress was detected in 101 (55%) patients, 60 of these met remaining inclusion criteria. The primary reason for ineligibility was poor computer literacy (N=17, 53%). Twenty-five patients were randomised to the supported (N=18) or unsupported arm (N=7); 92% were retained at follow-up. No differences in psychological distress or cost-effectiveness were observed. No trial adverse events occurred. Online CBT appears feasible but only for computer literate patients who identify with the label psychological distress. A definitive trial using the current methods for psychological distress screening and online care delivery is unfeasible. ClinicalTrials.gov Identifier: NCT02352870. Copyright © 2017 Elsevier Inc. All rights reserved.

  8. 33 CFR 80.135 - Hull, MA to Race Point, MA.

    Science.gov (United States)

    2010-07-01

    ... 33 Navigation and Navigable Waters 1 2010-07-01 2010-07-01 false Hull, MA to Race Point, MA. 80... INTERNATIONAL NAVIGATION RULES COLREGS DEMARCATION LINES Atlantic Coast § 80.135 Hull, MA to Race Point, MA. (a... the east coast of Massachusetts from the easternmost radio tower at Hull, charted in approximate...

  9. Rigorous Analysis of a Randomised Number Field Sieve

    OpenAIRE

    Lee, Jonathan; Venkatesan, Ramarathnam

    2018-01-01

    Factorisation of integers $n$ is of number theoretic and cryptographic significance. The Number Field Sieve (NFS) introduced circa 1990, is still the state of the art algorithm, but no rigorous proof that it halts or generates relationships is known. We propose and analyse an explicitly randomised variant. For each $n$, we show that these randomised variants of the NFS and Coppersmith's multiple polynomial sieve find congruences of squares in expected times matching the best-known heuristic e...

  10. Educational outreach to general practitioners reduces children's asthma symptoms: a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Sladden Michael

    2007-09-01

    Full Text Available Abstract Background Childhood asthma is common in Cape Town, a province of South Africa, but is underdiagnosed by general practitioners. Medications are often prescribed inappropriately, and care is episodic. The objective of this study is to assess the impact of educational outreach to general practitioners on asthma symptoms of children in their practice. Methods This is a cluster randomised trial with general practices as the unit of intervention, randomisation, and analysis. The setting is Mitchells Plain (population 300,000, a dormitory town near Cape Town. Solo general practitioners, without nurse support, operate from storefront practices. Caregiver-reported symptom data were collected for 318 eligible children (2 to 17 years with moderate to severe asthma, who were attending general practitioners in Mitchells Plain. One year post-intervention follow-up data were collected for 271 (85% of these children in all 43 practices. Practices randomised to intervention (21 received two 30-minute educational outreach visits by a trained pharmacist who left materials describing key interventions to improve asthma care. Intervention and control practices received the national childhood asthma guideline. Asthma severity was measured in a parent-completed survey administered through schools using a symptom frequency and severity scale. We compared intervention and control group children on the change in score from pre-to one-year post-intervention. Results Symptom scores declined an additional 0.84 points in the intervention vs. control group (on a nine-point scale. p = 0.03. For every 12 children with asthma exposed to a doctor allocated to the intervention, one extra child will have substantially reduced symptoms. Conclusion Educational outreach was accepted by general practitioners and was effective. It could be applied to other health care quality problems in this setting.

  11. Podoconiosis treatment in northern Ethiopia (GoLBet): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Negussie, Henok; Kassahun, Meseret Molla; Fegan, Greg; Njuguna, Patricia; Enquselassie, Fikre; McKay, Andy; Newport, Melanie; Lang, Trudie; Davey, Gail

    2015-07-16

    Podoconiosis is one of the forgotten types of leg swelling (elephantiasis) in the tropics. Unlike the other, better-known types of leg swelling, podoconiosis is not caused by any parasite, virus or bacterium, but by an abnormal reaction to minerals found in the clay soils of some tropical highland areas. Non-governmental Organizations (NGOs) have been responsible for the development of simple treatment methods without systematic evaluation of its effectiveness. It is essential that a large scale, fully controlled, pragmatic trial of the intervention is conducted. We aim to test the hypothesis that community-based treatment of podoconiosis lymphoedema reduces the frequency of acute dermatolymphangioadenitis episodes ('acute attacks') and improves other clinical, social and economic outcomes. This is a pragmatic, individually randomised controlled trial. We plan to randomly allocate 680 podoconiosis patients from the East Gojjam Zone in northern Ethiopia to one of two groups: 'Standard Treatment' or 'Delayed Treatment'. Those randomised to standard treatment will receive the hygiene and foot-care intervention from May 2015 for one year, whereas those in the control arm will be followed through 2015 and be offered the intervention in 2016. The trial will be preceded by an economic context survey and a Rapid Ethical Assessment to identify optimal methods of conveying information about the trial and the approaches to obtaining informed consent preferred by the community. The primary outcome will be measured by recording patient recall and using a simple, patient-held diary that will be developed to record episodes of acute attacks. Adherence to treatment, clinical stage of disease, quality of life, disability and stigma will be considered secondary outcome measures. Other outcomes will include adverse events and economic productivity. Assessments will be made at baseline and at 3, 6, 9 and 12 months thereafter. The evidence is highly likely to inform implementation of

  12. Comparative effectiveness of Pilates and yoga group exercise interventions for chronic mechanical neck pain: quasi-randomised parallel controlled study.

    Science.gov (United States)

    Dunleavy, K; Kava, K; Goldberg, A; Malek, M H; Talley, S A; Tutag-Lehr, V; Hildreth, J

    2016-09-01

    To determine the effectiveness of Pilates and yoga group exercise interventions for individuals with chronic neck pain (CNP). Quasi-randomised parallel controlled study. Community, university and private practice settings in four locations. Fifty-six individuals with CNP scoring ≥3/10 on the numeric pain rating scale for >3 months (controls n=17, Pilates n=20, yoga n=19). Exercise participants completed 12 small-group sessions with modifications and progressions supervised by a physiotherapist. The primary outcome measure was the Neck Disability Index (NDI). Secondary outcomes were pain ratings, range of movement and postural measurements collected at baseline, 6 weeks and 12 weeks. Follow-up was performed 6 weeks after completion of the exercise classes (Week 18). NDI decreased significantly in the Pilates {baseline: 11.1 [standard deviation (SD) 4.3] vs Week 12: 6.8 (SD 4.3); mean difference -4.3 (95% confidence interval -1.64 to -6.7); PPilates and yoga group exercise interventions with appropriate modifications and supervision were safe and equally effective for decreasing disability and pain compared with the control group for individuals with mild-to-moderate CNP. Physiotherapists may consider including these approaches in a plan of care. ClinicalTrials.gov NCT01999283. Copyright © 2015 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

  13. Occupational therapy for stroke patients not admitted to hospital: a randomised controlled trial.

    Science.gov (United States)

    Walker, M F; Gladman, J R; Lincoln, N B; Siemonsma, P; Whiteley, T

    1999-07-24

    Patients who have a stroke are not always admitted to hospital, and 22-60% remain in the community, frequently without coordinated rehabilitation. We aimed to assess the efficacy of an occupational therapy intervention for patients with stroke who were not admitted to hospital. In this single-blind randomised controlled trial, consecutive stroke patients on a UK community register in Nottingham and Derbyshire were allocated randomly to up to 5 months of occupational therapy at home or to no intervention (control group) 1 month after their stroke. The aim of the occupational therapy was to encourage independence in personal and instrumental activities of daily living. Patients were assessed on outcome measures at baseline (before randomisation) and at 6 months. The primary outcome measure was the score on the extended activities of daily living (EADL) scale at 6 months. Other outcome measures included the Barthel index, the general health questionnaire 28, the carer strain index, and the London handicap scale. All assessments were done by an independent assessor who was unaware of treatment allocation. The analysis included only data from completed questionnaires. 185 patients were included: 94 in the occupational therapy group and 91 in the control group. 22 patients were not assessed at 6 months. At follow-up, patients who had occupational therapy had significantly higher median scores than the controls on: the EADL scale (16 vs 12, pstroke who were not admitted to hospital.

  14. 42 CFR 495.202 - Identification of qualifying MA organizations, MA-EPs and MA-affiliated eligible hospitals.

    Science.gov (United States)

    2010-10-01

    ... qualifying MA-affiliated eligible hospitals under the MA EHR incentive program are required to identify...-EPs and MA-affiliated eligible hospitals. 495.202 Section 495.202 Public Health CENTERS FOR MEDICARE... STANDARDS FOR THE ELECTRONIC HEALTH RECORD TECHNOLOGY INCENTIVE PROGRAM Requirements Specific to Medicare...

  15. Efficacy of 'Tailored Physical Activity' on reducing sickness absence among health care workers: A 3-months randomised controlled trial.

    Science.gov (United States)

    Andersen, Lotte Nygaard; Juul-Kristensen, Birgit; Roessler, Kirsten Kaya; Herborg, Lene Gram; Sørensen, Thomas Lund; Søgaard, Karen

    2015-10-01

    The aim was to evaluate efficacy of "Tailored Physical Activity" (TPA) versus a reference group (REF) in reducing the number of self-reported days of sickness absence for health care workers in the Sonderborg Municipality. In this randomised controlled trial, all participants (n = 54) received health guidance for 1.5 h and were randomised to TPA or REF. The primary aim was to make a comparison of participants' self-reported sickness absence due to musculoskeletal troubles measured three months after baseline. Secondary outcomes included anthropometric, health-related and physical capacity measures. A TPA intervention was not significantly more effective than REF in reducing sickness absence caused by musculoskeletal troubles. However, there were significant improvements for TPA participants compared to REF in reducing pain intensity from 47.9 mm to 21.8 mm (p health care workers since participants achieved a substantial effect on their experience of pain, on their work ability and on their fear of physical movement relating to pain. Moreover, a difference in aerobic capacity was apparent between the sample groups. TPA however, had no significant effect in reducing sickness absence days. Copyright © 2015 Elsevier Ltd. All rights reserved.

  16. Topical glyceryl trinitrate treatment of chronic patellar tendinopathy : a randomised, double-blind, placebo-controlled clinical trial

    NARCIS (Netherlands)

    Steunebrink, Mirjam; Zwerver, Johannes; Brandsema, Ruben; Groenenboom, Petra; van den Akker-Scheek, Inge; Weir, Adam

    Objectives To assess if continuous topical glyceryl trinitrate (GTN) treatment improves outcome in patients with chronic patellar tendinopathy when compared with eccentric training alone. Methods Randomised double-blind, placebo-controlled clinical trial comparing a 12-week programme of using a GTN

  17. Fracture fixation in the operative management of hip fractures (FAITH): an international, multicentre, randomised controlled trial

    NARCIS (Netherlands)

    Nauth, A. (Aaron); Creek, A.T. (Aaron T.); Zellar, A. (Abby); Lawendy, A.-R. (Abdel-Rahman); Dowrick, A. (Adam); Gupta, A. (Ajay); Dadi, A. (Akhil); A. van Kampen (A.); Yee, A. (Albert); A.C. de Vries (Alexander); de Mol van Otterloo, A. (Alexander); Garibaldi, A. (Alisha); Liew, A. (Allen); McIntyre, A.W. (Allison W.); Prasad, A.S. (Amal Shankar); Romero, A.W. (Amanda W.); Rangan, A. (Amar); Oatt, A. (Amber); Sanghavi, A. (Amir); Foley, A.L. (Amy L.); Karlsten, A. (Anders); Dolenc, A. (Andrea); Bucknill, A. (Andrew); Chia, A. (Andrew); Evans, A. (Andrew); Gong, A. (Andrew); Schmidt, A.H. (Andrew H.); Marcantonio, A.J. (Andrew J.); Jennings, A. (Andrew); Ward, A. (Angela); Khanna, A. (Angshuman); Rai, A. (Anil); Smits, A.B. (Anke B.); Horan, A.D. (Annamarie D.); Brekke, A.C. (Anne Christine); Flynn, A. (Annette); Duraikannan, A. (Aravin); Stødle, A. (Are); van Vugt, A.B. (Arie B.); Luther, A. (Arlene); Zurcher, A.W. (Arthur W.); Jain, A. (Arvind); Amundsen, A. (Asgeir); Moaveni, A. (Ash); Carr, A. (Ashley); Sharma, A. (Ateet); Hill, A.D. (Austin D.); Trommer, A. (Axel); Rai, B.S. (B. Sachidananda); Hileman, B. (Barbara); Schreurs, B. (Bart); Verhoeven, B. (Bart); Barden, B.B. (Benjamin B.); Flatøy, B. (Bernhard); B.I. Cleffken (Berry); Bøe, B. (Berthe); Perey, B. (Bertrand); Hanusch, B.C. (Birgit C.); Weening, B. (Brad); B. Fioole (Bram); Rijbroek, B. (Bram); Crist, B.D. (Brett D.); Halliday, B. (Brett); Peterson, B. (Brett); Mullis, B. (Brian); Richardson, C.G. (C. Glen); Clark, C. (Callum); Sagebien, C.A. (Carlos A.); C. van der Pol (Carmen); Bowler, C. (Carol); Humphrey, C.A. (Catherine A.); Coady, C. (Catherine); Koppert, C.L. (Cees L.); Coles, C. (Chad); Tannoury, C. (Chadi); DePaolo, C.J. (Charles J.); Gayton, C. (Chris); Herriott, C. (Chris); Reeves, C. (Christina); Tieszer, C. (Christina); Dobb, C. (Christine); Anderson, C.G. (Christopher G.); Sage, C. (Claire); Cuento, C. (Claudine); Jones, C.B. (Clifford B.); Bosman, C.H.R. (Coks H.R.); Linehan, C. (Colleen); C.P. van der Hart (Cor P.); Henderson, C. (Corey); Lewis, C.G. (Courtland G.); Davis, C.A. (Craig A.); Donohue, C. (Craig); Mauffrey, C. (Cyril); Sundaresh, D.C. (D. C.); Farrell, D.J. (Dana J.); Whelan, D.B. (Daniel B.); Horwitz, D. (Daniel); Stinner, D. (Daniel); Viskontas, D. (Darius); Roffey, D.M. (Darren M.); Alexander, D. (David); Karges, D.E. (David E.); Hak, D. (David); Johnston, D. (David); Love, D. (David); Wright, D.M. (David M.); Zamorano, D.P. (David P.); Goetz, D.R. (David R.); Sanders, D. (David); Stephen, D. (David); Yen, D. (David); Bardana, D. (Davide); Olakkengil, D.J. (Davy J); Lawson, D. (Deanna); Maddock, D. (Deborah); Sietsema, D.L. (Debra L.); Pourmand, D. (Deeba); D. den Hartog (Dennis); Donegan, D. (Derek); D. Heels-Ansdell (Diane); Nam, D. (Diane); Inman, D. (Dominic); Boyer, D. (Dory); Li, D. (Doug); Gibula, D. (Douglas); Price, D.M. (Dustin M.); Watson, D.J. (Dylan J.); Hammerberg, E.M. (E. Mark); Tan, E.T.C.H. (Edward T.C.H.); E.J.R. de Graaf (Eelco); Vesterhus, E.B. (Elise Berg); Roper, E. (Elizabeth); Edwards, E. (Elton); E.H. Schemitsch (Emil); E.R. Hammacher (Eric); Henderson, E.R. (Eric R.); Whatley, E. (Erica); Torres, E.T. (Erick T.); Vermeulen, E.G.J. (Erik G.J.); Finn, E. (Erin); E.M.M. van Lieshout (Esther); Wai, E.K. (Eugene K.); Bannister, E.R. (Evan R.); Kile, E. (Evelyn); Theunissen, E.B.M. (Evert B.M.); Ritchie, E.D. (Ewan D.); Khan, F. (Farah); Moola, F. (Farhad); Howells, F. (Fiona); F. de Nies (Frank); F.H.W.M. van der Heijden (Frank); de Meulemeester, F.R.A.J. (Frank R.A.J.); F. Frihagen (Frede); Nilsen, F. (Fredrik); Schmidt, G.B. (G. Ben); Albers, G.H.R. (G.H. Robert); Gudger, G.K. (Garland K.); Johnson, G. (Garth); Gruen, G. (Gary); Zohman, G. (Gary); Sharma, G. (Gaurav); Wood, G. (Gavin); G.W.M. Tetteroo (Geert); Hjorthaug, G. (Geir); Jomaas, G. (Geir); Donald, G. (Geoff); Rieser, G.R. (Geoffrey Ryan); Reardon, G. (Gerald); Slobogean, G.P. (Gerard P.); G.R. Roukema (Gert); Visser, G.A. (Gijs A.); Moatshe, G. (Gilbert); Horner, G. (Gillian); Rose, G. (Glynis); Guyatt, G. (Gordon); Chuter, G. (Graham); Etherington, G. (Greg); Rocca, G.J.D. (Gregory J. Della); Ekås, G. (Guri); Dobbin, G. (Gwendolyn); Lemke, H.M. (H. Michael); Curry, H. (Hamish); H. Boxma (Han); Gissel, H. (Hannah); Kreder, H. (Hans); Kuiken, H. (Hans); H.L.F. Brom; Pape, H.-C. (Hans-Christoph); H.M. van der Vis (Harm); Bedi, H. (Harvinder); Vallier, H.A. (Heather A.); Brien, H. (Heather); Silva, H. (Heather); Newman, H. (Heike); H. Viveiros (Helena); van der Hoeven, H. (Henk); Ahn, H. (Henry); Johal, H. (Herman); H. Rijna; Stockmann, H. (Heyn); Josaputra, H.A. (Hong A.); Carlisle, H. (Hope); van der Brand, I. (Igor); I. Dawson (Imro); Tarkin, I. (Ivan); Wong, I. (Ivan); Parr, J.A. (J. Andrew); Trenholm, J.A. (J. Andrew); J.C. Goslings (Carel); Amirault, J.D. (J. David); Broderick, J.S. (J. Scott); Snellen, J.P. (Jaap P.); Zijl, J.A.C. (Jacco A.C.); Ahn, J. (Jaimo); Ficke, J. (James); Irrgang, J. (James); Powell, J. (James); Ringler, J.R. (James R.); Shaer, J. (James); Monica, J.T. (James T.); J. Biert (Jan); Bosma, J. (Jan); Brattgjerd, J.E. (Jan Egil); J.P.M. Frölke (Jan Paul); J.C. Wille (Jan); Rajakumar, J. (Janakiraman); Walker, J.E. (Jane E.); Baker, J.K. (Janell K.); Ertl, J.P. (Janos P.); de Vries, J.P.P.M. (Jean Paul P.M.); Gardeniers, J.W.M. (Jean W.M.); May, J. (Jedediah); Yach, J. (Jeff); Hidy, J.T. (Jennifer T.); Westberg, J.R. (Jerald R.); Hall, J.A. (Jeremy A.); van Mulken, J. (Jeroen); McBeth, J.C. (Jessica Cooper); Hoogendoorn, J. (Jochem); Hoffman, J.M. (Jodi M.); Cherian, J.J. (Joe Joseph); Tanksley, J.A. (John A.); Clarke-Jenssen, J. (John); Adams, J.D. (John D.); Esterhai, J. (John); Tilzey, J.F. (John F.); Murnaghan, J. (John); Ketz, J.P. (John P.); Garfi, J.S. (John S.); Schwappach, J. (John); Gorczyca, J.T. (John T.); Wyrick, J. (John); Rydinge, J. (Jonas); Foret, J.L. (Jonathan L.); Gross, J.M. (Jonathan M.); Keeve, J.P. (Jonathan P.); Meijer, J. (Joost); J.J. Scheepers (Joris J.); Baele, J. (Joseph); O'Neil, J. (Joseph); Cass, J.R. (Joseph R.); Hsu, J.R. (Joseph R.); Dumais, J. (Jules); Lee, J. (Julia); Switzer, J.A. (Julie A.); Agel, J. (Julie); Richards, J.E. (Justin E.); Langan, J.W. (Justin W.); Turckan, K. (Kahn); Pecorella, K. (Kaili); Rai, K. (Kamal); Aurang, K. (Kamran); Shively, K. (Karl); K.J.P. van Wessem; Moon, K. (Karyn); Eke, K. (Kate); Erwin, K. (Katie); Milner, K. (Katrine); K.J. Ponsen (Kees-jan); Mills, K. (Kelli); Apostle, K. (Kelly); Johnston, K. (Kelly); Trask, K. (Kelly); Strohecker, K. (Kent); Stringfellow, K. (Kenya); Kruse, K.K. (Kevin K.); Tetsworth, K. (Kevin); Mitchell, K. (Khalis); Browner, K. (Kieran); Hemlock, K. (Kim); Carcary, K. (Kimberly); Jørgen Haug, K. (Knut); Noble, K. (Krista); Robbins, K. (Kristin); Payton, K. (Krystal); Jeray, K.J. (Kyle J.); Rubino, L.J. (L. Joseph); Nastoff, L.A. (Lauren A.); Leffler, L.C. (Lauren C.); L.P. Stassen (Laurents); O'Malley, L.K. (Lawrence K.); Specht, L.M. (Lawrence M.); L. Thabane (Lehana); Geeraedts, L.M.G. (Leo M.G.); Shell, L.E. (Leslie E.); Anderson, L.K. (Linda K.); Eickhoff, L.S. (Linda S.); Lyle, L. (Lindsey); Pilling, L. (Lindsey); Buckingham, L. (Lisa); Cannada, L.K. (Lisa K.); Wild, L.M. (Lisa M.); Dulaney-Cripe, L. (Liz); L.M.S.J. Poelhekke; Govaert, L. (Lonneke); Ton, L. (Lu); Kottam, L. (Lucksy); L.P.H. Leenen (Luke); Clipper, L. (Lydia); Jackson, L.T. (Lyle T.); Hampton, L. (Lynne); de Waal Malefijt, M.C. (Maarten C.); M.P. Simons; M. van der Elst (Maarten); M.W.G.A. Bronkhorst (Maarten); Bhatia, M. (Mahesh); M.F. Swiontkowski (Marc ); Lobo, M.J. (Margaret J.); Swinton, M. (Marilyn); Pirpiris, M. (Marinis); Molund, M. (Marius); Gichuru, M. (Mark); Glazebrook, M. (Mark); Harrison, M. (Mark); Jenkins, M. (Mark); MacLeod, M. (Mark); M.R. de Vries (Mark); Butler, M.S. (Mark S.); Nousiainen, M. (Markku); van ‘t Riet, M. (Martijne); Tynan, M.C. (Martin C.); Campo, M. (Martin); M.G. Eversdijk (Martin); M.J. Heetveld (Martin); Richardson, M. (Martin); Breslin, M. (Mary); Fan, M. (Mary); Edison, M. (Matt); Napierala, M. (Matthew); Knobe, M. (Matthias); Russ, M. (Matthias); Zomar, M. (Mauri); de Brauw, M. (Maurits); Esser, M. (Max); Hurley, M. (Meghan); Peters, M.E. (Melissa E.); Lorenzo, M. (Melissa); Li, M. (Mengnai); Archdeacon, M. (Michael); Biddulph, M. (Michael); Charlton, M. (Michael); McDonald, M.D. (Michael D.); McKee, M.D. (Michael D.); Dunbar, M. (Michael); Torchia, M.E. (Michael E.); Gross, M. (Michael); Hewitt, M. (Michael); Holt, M. (Michael); Prayson, M.J. (Michael J.); M.J.R. Edwards (Michael); Beckish, M.L. (Michael L.); Brennan, M.L. (Michael L.); Dohm, M.P. (Michael P.); Kain, M.S.H. (Michael S.H.); Vogt, M. (Michelle); Yu, M. (Michelle); M.H.J. Verhofstad (Michiel); Segers, M.J.M. (Michiel J.M.); M.J.M. Segers (Michiel); Siroen, M.P.C. (Michiel P.C.); M.R. Reed (Mike); Vicente, M.R. (Milena R.); M.M.M. Bruijninckx (Milko); Trivedi, M. (Mittal); M. Bhandari (Mohit); Moore, M.M. (Molly M.); Kunz, M. (Monica); Smedsrud, M. (Morten); Palla, N. (Naveen); Jain, N. (Neeraj); Out, N.J.M. (Nico J.M.); Simunovic, N. (Nicole); Simunovic, N. (Nicole); N.W.L. Schep (Niels); Müller, O. (Oliver); Guicherit, O.R. (Onno R.); O.J.F. van Waes (Oscar); Wang, O. (Otis); P. Doornebosch (Pascal); Seuffert, P. (Patricia); Hesketh, P.J. (Patrick J.); Weinrauch, P. (Patrick); Duffy, P. (Paul); Keller, P. (Paul); Lafferty, P.M. (Paul M.); Pincus, P. (Paul); P. Tornetta III (Paul); Zalzal, P. (Paul); McKay, P. (Paula); Cole, P.A. (Peter A.); de Rooij, P.D. (Peter D.); Hull, P. (Peter); Go, P.M.N.Y.M. (Peter M.N.Y.M.); P. Patka (Peter); Siska, P. (Peter); Weingarten, P. (Peter); Kregor, P. (Philip); Stahel, P. (Philip); Stull, P. (Philip); P. Wittich (Philippe); P.A.R. Rijcke (Piet); P.P. Oprel (Pim); Devereaux, P.J. (P. J.); Zhou, Q. (Qi); Lee Murphy, R. (R.); Alosky, R. (Rachel); Clarkson, R. (Rachel); Moon, R. (Raely); Logishetty, R. (Rajanikanth); Nanda, R. (Rajesh); Sullivan, R.J. (Raymond J.); Snider, R.G. (Rebecca G.); Buckley, R.E. (Richard E.); Iorio, R. (Richard); Farrugia, R.J. (Richard J); Jenkinson, R. (Richard); Laughlin, R. (Richard); R.P.R. Groenendijk (Richard); Gurich, R.W. (Richard W.); Worman, R. (Ripley); Silvis, R. (Rob); R. Haverlag (Robert); Teasdall, R.J. (Robert J.); Korley, R. (Robert); McCormack, R. (Robert); Probe, R. (Robert); Cantu, R.V. (Robert V.); Huff, R.B. (Roger B.); R.K.J. Simmermacher; Peters, R. (Rolf); Pfeifer, R. (Roman); Liem, R. (Ronald); Wessel, R.N. (Ronald N.); Verhagen, R. (Ronald); Vuylsteke, R. (Ronald); Leighton, R. (Ross); McKercher, R. (Ross); R.W. Poolman (Rudolf); Miller, R. (Russell); Bicknell, R. (Ryan); Finnan, R. (Ryan); Khan, R.M. (Ryan M.); Mehta, S. (Samir); Vang, S. (Sandy); Singh, S. (Sanjay); Anand, S. (Sanjeev); Anderson, S.A. (Sarah A.); Dawson, S.A. (Sarah A.); Marston, S.B. (Scott B.); Porter, S.E. (Scott E.); Watson, S.T. (Scott T.); S. Festen (Sebastiaan); Lieberman, S. (Shane); Puloski, S. (Shannon); Bielby, S.A. (Shea A.); Sprague, S. (Sheila); Hess, S. (Shelley); MacDonald, S. (Shelley); Evans, S. (Simone); Bzovsky, S. (Sofia); Hasselund, S. (Sondre); Lewis, S. (Sophie); Ugland, S. (Stein); Caminiti, S. (Stephanie); Tanner, S.L. (Stephanie L.); S.M. Zielinski (Stephanie); Shepard, S. (Stephanie); Sems, S.A. (Stephen A.); Walter, S.D. (Stephen D.); Doig, S. (Stephen); Finley, S.H. (Stephen H.); Kates, S. (Stephen); Lindenbaum, S. (Stephen); Kingwell, S.P. (Stephen P.); Csongvay, S. (Steve); Papp, S. (Steve); Buijk, S.E. (Steven E.); S. Rhemrev (Steven); Hollenbeck, S.M. (Steven M.); van Gaalen, S.M. (Steven M.); Yang, S. (Steven); Weinerman, S. (Stuart); Subash, (); Lambert, S. (Sue); Liew, S. (Susan); S.A.G. Meylaerts (Sven); Blokhuis, T.J. (Taco J.); de Vries Reilingh, T.S. (Tammo S.); Lona, T. (Tarjei); Scott, T. (Taryn); Swenson, T.K. (Teresa K.); Endres, T.J. (Terrence J.); Axelrod, T. (Terry); van Egmond, T. (Teun); Pace, T.B. (Thomas B.); Kibsgård, T. (Thomas); Schaller, T.M. (Thomas M.); Ly, T.V. (Thuan V.); Miller, T.J. (Timothy J.); Weber, T. (Timothy); Le, T. (Toan); Oliver, T.M. (Todd M.); T.M. Karsten (Thomas); Borch, T. (Tor); Hoseth, T.M. (Tor Magne); Nicolaisen, T. (Tor); Ianssen, T. (Torben); Rutherford, T. (Tori); Nanney, T. (Tracy); Gervais, T. (Trevor); Stone, T. (Trevor); Schrickel, T. (Tyson); Scrabeck, T. (Tyson); Ganguly, U. (Utsav); Naumetz, V. (V.); Frizzell, V. (Valda); Wadey, V. (Veronica); Jones, V. (Vicki); Avram, V. (Victoria); Mishra, V. (Vimlesh); Yadav, V. (Vineet); Arora, V. (Vinod); Tyagi, V. (Vivek); Borsella, V. (Vivian); W.J. Willems (Jaap); Hoffman, W.H. (W. H.); Gofton, W.T. (Wade T.); Lackey, W.G. (Wesley G.); Ghent, W. (Wesley); Obremskey, W. (William); Oxner, W. (William); Cross, W.W. (William W.); Murtha, Y.M. (Yvonne M.); Murdoch, Z. (Zoe)

    2017-01-01

    textabstractBackground Reoperation rates are high after surgery for hip fractures. We investigated the effect of a sliding hip screw versus cancellous screws on the risk of reoperation and other key outcomes. Methods For this international, multicentre, allocation concealed randomised controlled

  18. Supplemental parenteral nutrition in critically ill patients: a study protocol for a phase II randomised controlled trial.

    Science.gov (United States)

    Ridley, Emma J; Davies, Andrew R; Parke, Rachael; Bailey, Michael; McArthur, Colin; Gillanders, Lyn; Cooper, David J; McGuinness, Shay

    2015-12-24

    Nutrition is one of the fundamentals of care provided to critically ill adults. The volume of enteral nutrition received, however, is often much less than prescribed due to multiple functional and process issues. To deliver the prescribed volume and correct the energy deficit associated with enteral nutrition alone, parenteral nutrition can be used in combination (termed "supplemental parenteral nutrition"), but benefits of this method have not been firmly established. A multi-centre, randomised, clinical trial is currently underway to determine if prescribed energy requirements can be provided to critically ill patients by using a supplemental parenteral nutrition strategy in the critically ill. This prospective, multi-centre, randomised, stratified, parallel-group, controlled, phase II trial aims to determine whether a supplemental parenteral nutrition strategy will reliably and safely increase energy intake when compared to usual care. The study will be conducted for 100 critically ill adults with at least one organ system failure and evidence of insufficient enteral intake from six intensive care units in Australia and New Zealand. Enrolled patients will be allocated to either a supplemental parenteral nutrition strategy for 7 days post randomisation or to usual care with enteral nutrition. The primary outcome will be the average energy amount delivered from nutrition therapy over the first 7 days of the study period. Secondary outcomes include protein delivery for 7 days post randomisation; total energy and protein delivery, antibiotic use and organ failure rates (up to 28 days); duration of ventilation, length of intensive care unit and hospital stay. At both intensive care unit and hospital discharge strength and health-related quality of life assessments will be undertaken. Study participants will be followed up for health-related quality of life, resource utilisation and survival at 90 and 180 days post randomisation (unless death occurs first). This trial

  19. Randomised controlled feasibility trial of an evidence-informed behavioural intervention for obese adults with additional risk factors.

    Directory of Open Access Journals (Sweden)

    Falko F Sniehotta

    Full Text Available Interventions for dietary and physical activity changes in obese adults may be less effective for participants with additional obesity-related risk factors and co-morbidities than for otherwise healthy individuals. This study aimed to test the feasibility and acceptability of the recruitment, allocation, measurement, retention and intervention procedures of a randomised controlled trial of an intervention to improve physical activity and dietary practices amongst obese adults with additional obesity related risk factors.Pilot single centre open-labelled outcome assessor-blinded randomised controlled trial of obese (Body Mass Index (BMI≥30 kg/m2 adults (age≥18 y with obesity related co-morbidities such as type 2 diabetes, impaired glucose tolerance or hypertension. Participants were randomly allocated to a manual-based group intervention or a leaflet control condition in accordance to a 2∶1 allocation ratio. Primary outcome was acceptability and feasibility of trial procedures, secondary outcomes included measures of body composition, physical activity, food intake and psychological process measures.Out of 806 potentially eligible individuals identified through list searches in two primary care general medical practices N = 81 participants (63% female; mean-age = 56.56(11.44; mean-BMI = 36.73(6.06 with 2.35(1.47 co-morbidities were randomised. Scottish Index of Multiple Deprivation (SIMD was the only significant predictor of providing consent to take part in the study (higher chances of consent for invitees with lower levels of deprivation. Participant flowcharts, qualitative and quantitative feedback suggested good acceptance and feasibility of intervention procedures but 34.6% of randomised participants were lost to follow-up due to overly high measurement burden and sub-optimal retention procedures. Participants in the intervention group showed positive trends for most psychological, behavioural and body composition outcomes

  20. Early combined immunosuppression for the management of Crohn's disease (REACT): a cluster randomised controlled trial.

    Science.gov (United States)

    Khanna, Reena; Bressler, Brian; Levesque, Barrett G; Zou, Guangyong; Stitt, Larry W; Greenberg, Gordon R; Panaccione, Remo; Bitton, Alain; Paré, Pierre; Vermeire, Séverine; D'Haens, Geert; MacIntosh, Donald; Sandborn, William J; Donner, Allan; Vandervoort, Margaret K; Morris, Joan C; Feagan, Brian G

    2015-11-07

    Conventional management of Crohn's disease features incremental use of therapies. However, early combined immunosuppression (ECI), with a TNF antagonist and antimetabolite might be a more effective strategy. We compared the efficacy of ECI with that of conventional management for treatment of Crohn's disease. In this open-label cluster randomised controlled trial (Randomised Evaluation of an Algorithm for Crohn's Treatment, REACT), we included community gastroenterology practices from Belgium and Canada that were willing to be assigned to either of the study groups, participate in all aspects of the study, and provide data on up to 60 patients with Crohn's disease. These practices were randomly assigned (1:1) to either ECI or conventional management. The computer-generated randomisation was minimised by country and practice size. Up to 60 consecutive adult patients were assessed within practices. Patients who were aged 18 years or older; documented to have Crohn's disease; able to speak or understand English, French, or Dutch; able to access a telephone; and able to provide written informed consent were followed up for 2 years. The primary outcome was the proportion of patients in corticosteroid-free remission (Harvey-Bradshaw Index score ≤ 4) at 12 months at the practice level. This trial is registered with ClinicalTrials.gov, number NCT01030809. This study took place between March 15, 2010, and Oct 1, 2013. Of the 60 practices screened, 41 were randomly assigned to either ECI (n=22) or conventional management (n=19). Two practices (one in each group) discontinued because of insufficient resources. 921 (85%) of the 1084 patients at ECI practices and 806 (90%) of 898 patients at conventional management practices completed 12 months follow-up and were included in an intention-to-treat analysis. The 12 month practice-level remission rates were similar at ECI and conventional management practices (66·0% [SD 14·0] and 61·9% [16·9]; adjusted difference 2·5%, 95

  1. Study protocol of a multicentre randomised controlled trial of self-help cognitive behaviour therapy for working women with menopausal symptoms (MENOS@Work).

    Science.gov (United States)

    Hunter, Myra S; Hardy, Claire; Norton, Sam; Griffiths, Amanda

    2016-10-01

    Hot flushes and night sweats (HFNS) - the main symptoms of the menopause transition - can reduce quality of life and are particularly difficult to manage at work. A cognitive behaviour therapy (CBT) intervention has been developed specifically for HFNS that is theoretically based and shown to reduce significantly the impact of HFNS in several randomised controlled trials (RCTs). Self-help CBT has been found to be as effective as group CBT for these symptoms, but these interventions are not widely available in the workplace. This paper describes the protocol of an RCT aiming to assess the efficacy of CBT for menopausal symptoms implemented in the workplace, with a nested qualitative study to examine acceptability and feasibility. One hundred menopausal working women, aged 45-60 years, experiencing bothersome HFNS for two months will be recruited from several (2-10) large organisations into a multicentre randomised controlled trial. Women will be randomly assigned to either treatment (a self-help CBT intervention lasting 4 weeks) or to a no treatment-wait control condition (NTWC), following a screening interview, consent, and completion of a baseline questionnaire. All participants will complete follow-up questionnaires at 6 weeks and 20 weeks post-randomisation. The primary outcome is the rating of HFNS; secondary measures include HFNS frequency, mood, quality of life, attitudes to menopause, HFNS beliefs and behaviours, work absence and presenteeism, job satisfaction, job stress, job performance, disclosure to managers and turnover intention. Adherence, acceptability and feasibility will be assessed at 20 weeks post-randomisation in questionnaires and qualitative interviews. Upon trial completion, the control group will also be offered the intervention. This is the first randomised controlled trial of a self-management intervention tailored for working women who have troublesome menopausal symptoms. Clin.Gov NCT02623374. Copyright © 2016 Elsevier Ireland Ltd. All

  2. Randomised controlled trial of routine individual feedback to improve rationality and reduce numbers of test requests.

    Science.gov (United States)

    Winkens, R A; Pop, P; Bugter-Maessen, A M; Grol, R P; Kester, A D; Beusmans, G H; Knottnerus, J A

    1995-02-25

    Feedback can be described as a way to provide information on doctors' performance to enable changes in future behaviour. Feedback is used with the aim of changing test-ordering behaviour. It can lead to reductions in test usage and cost savings. It is not sufficiently clear, however, whether feedback leads to more appropriate test use. Since 1985, the Diagnostic Coordinating Center Maastricht has been giving feedback on diagnostic tests as a routine health care activity to all family doctors in its region. Both quantity and quality of requests are discussed. In a randomised, controlled trial over 2.5 years, discussion of tests not included previously was added to the existing routine feedback. One group of family doctors (n = 39) received feedback on test-group A (electrocardiography, endoscopy, cervical smears, and allergy tests), the other (n = 40) on test-group B (radiographic and ultrasonographic tests). Thus, each group of doctors acted as a control group for the other. Changes in volume and rationality of requests were analysed. The number of requests decreased during the trial (p = 0.036). Request numbers decreased particularly for test-group A (p = 0.04). The proportion of requests that were non-rational decreased more in the intervention than in the control groups (p = 0.009). Rationality improved predominantly for test-group B (p = 0.043). Thus, routine feedback can change the quantity and quality of requests.

  3. 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

  4. Intra-articular bupivacaine after joint arthroplasty: a systematic review and meta-analysis of randomised placebo-controlled studies

    Science.gov (United States)

    Cui, Yang; Yang, Tuo; Zeng, Chao; Wei, Jie; Xie, Xi; Li, Liangjun; Ding, Xiang; Zhang, Yi; Lei, Guanghua

    2016-01-01

    Objectives To evaluate the efficacy and safety of intra-articular (IA) bupivacaine administered for pain relief after joint arthroplasty. Design Meta-analysis. Methods A systematic review was conducted to identify the randomised controlled trials using IA bupivacaine for postoperative pain relief from MEDLINE, Cochrane Library and EMBASE databases (up to October 2015). The standardised mean difference (SMD), the relative risk (RR) and their corresponding 95% CIs were calculated using the RevMan statistical software. Results A total of 11 randomised controlled trials were included. Statistically significant differences between IA bupivacaine and placebo were observed for the mean visual analogue scale (VAS) values (SMD −0.55; 95% CI −0.89 to −0.22; pbupivacaine after joint arthroplasty is effective for pain relief without increasing adverse effects. PMID:27406643

  5. Prospective, double-blinded, randomised controlled trial assessing the effect of an Octenidine-based hydrogel on bacterial colonisation and epithelialization of skin graft wounds in burn patients.

    Science.gov (United States)

    W, Eisenbeiß; F, Siemers; G, Amtsberg; P, Hinz; B, Hartmann; T, Kohlmann; A, Ekkernkamp; U, Albrecht; O, Assadian; A, Kramer

    2012-01-01

    Moist wound treatment improves healing of skin graft donor site wounds. Microbial colonised wounds represent an increased risk of wound infection; while antimicrobially active, topical antiseptics may impair epithelialization. The aim of this prospective randomised controlled clinical trial was to examine the influence of an Octenidine-dihydrochloride (OCT) hydrogel on bacterial colonisation and epithelialization of skin graft donor sites. The study was designed as a randomised, double-blinded, controlled clinical trial. Skin graft donor sites from a total of 61 patients were covered either with 0.05% OCT (n=31) or an OCT-free placebo wound hydrogel (n=30). Potential interaction with wound healing was assessed by measuring the time until 100% re-epithelialization. In addition, microbial wound colonisation was quantitatively determined in all skin graft donor sites. There was no statistically significant difference in the time for complete epithelialization of skin graft donor sites in the OCT and the placebo group (7.3±0.2 vs. 6.9±0.2 days; p=0.236). Microbial wound colonisation was significantly lower in the OCT group than in the placebo group (p=0.014). The OCT-based hydrogel showed no delay in wound epithelialization and demonstrated a significantly lower bacterial colonisation of skin graft donor site wounds.

  6. Comprehensive geriatric assessment for older adults admitted to hospital: meta-analysis of randomised controlled trials

    OpenAIRE

    Ellis, G.; Whitehead, M.A.; Robinson, D.; O'Neill, D.; Langhorne, P.

    2011-01-01

    Objective - To evaluate the effectiveness of comprehensive geriatric assessment in hospital for older adults admitted as an emergency.\\ud \\ud Search strategy - We searched the EPOC Register, Cochrane’s Controlled Trials Register, the Database of Abstracts of Reviews of Effects (DARE), Medline, Embase, CINAHL, AARP Ageline, and handsearched high yield journals.\\ud \\ud Selection criteria - Randomised controlled trials of comprehensive geriatric assessment (whether by mobile teams or in designat...

  7. The Effects of Clinical Hypnosis versus Neurolinguistic Programming (NLP) before External Cephalic Version (ECV): A Prospective Off-Centre Randomised, Double-Blind, Controlled Trial.

    Science.gov (United States)

    Reinhard, Joscha; Peiffer, Swati; Sänger, Nicole; Herrmann, Eva; Yuan, Juping; Louwen, Frank

    2012-01-01

    Objective. To examine the effects of clinical hypnosis versus NLP intervention on the success rate of ECV procedures in comparison to a control group. Methods. A prospective off-centre randomised trial of a clinical hypnosis intervention against NLP of women with a singleton breech fetus at or after 37(0/7) (259 days) weeks of gestation and normal amniotic fluid index. All 80 participants heard a 20-minute recorded intervention via head phones. Main outcome assessed was success rate of ECV. The intervention groups were compared with a control group with standard medical care alone (n = 122). Results. A total of 42 women, who received a hypnosis intervention prior to ECV, had a 40.5% (n = 17), successful ECV, whereas 38 women, who received NLP, had a 44.7% (n = 17) successful ECV (P > 0.05). The control group had similar patient characteristics compared to the intervention groups (P > 0.05). In the control group (n = 122) 27.3% (n = 33) had a statistically significant lower successful ECV procedure than NLP (P = 0.05) and hypnosis and NLP (P = 0.03). Conclusions. These findings suggest that prior clinical hypnosis and NLP have similar success rates of ECV procedures and are both superior to standard medical care alone.

  8. Continuous versus intermittent endotracheal cuff pressure control for the prevention of ventilator-associated respiratory infections in Vietnam: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Dat, Vu Quoc; Geskus, Ronald B; Wolbers, Marcel; Loan, Huynh Thi; Yen, Lam Minh; Binh, Nguyen Thien; Chien, Le Thanh; Mai, Nguyen Thi Hoang; Phu, Nguyen Hoan; Lan, Nguyen Phu Huong; Hao, Nguyen Van; Long, Hoang Bao; Thuy, Tran Phuong; Kinh, Nguyen Van; Trung, Nguyen Vu; Phu, Vu Dinh; Cap, Nguyen Trung; Trinh, Dao Tuyet; Campbell, James; Kestelyn, Evelyne; Wertheim, Heiman F L; Wyncoll, Duncan; Thwaites, Guy Edward; van Doorn, H Rogier; Thwaites, C Louise; Nadjm, Behzad

    2018-04-04

    Ventilator-associated respiratory infection (VARI) comprises ventilator-associated pneumonia (VAP) and ventilator-associated tracheobronchitis (VAT). Although their diagnostic criteria vary, together these are the most common hospital-acquired infections in intensive care units (ICUs) worldwide, responsible for a large proportion of antibiotic use within ICUs. Evidence-based strategies for the prevention of VARI in resource-limited settings are lacking. Preventing the leakage of oropharyngeal secretions into the lung using continuous endotracheal cuff pressure control is a promising strategy. The aim of this study is to investigate the efficacy of automated, continuous endotracheal cuff pressure control in preventing the development of VARI and reducing antibiotic use in ICUs in Vietnam. This is an open-label randomised controlled multicentre trial. We will enrol 600 adult patients intubated for ≤ 24 h at the time of enrolment. Eligible patients will be stratified according to admission diagnosis (180 tetanus, 420 non-tetanus) and site and will be randomised in a 1:1 ratio to receive either (1) automated, continuous control of endotracheal cuff pressure or (2) intermittent measurement and control of endotracheal cuff pressure using a manual cuff pressure meter. The primary outcome is the occurrence of VARI, defined as either VAP or VAT during the ICU admission up to a maximum of 90 days after randomisation. Patients in both groups who are at risk for VARI will receive a standardised battery of investigations if their treating physician feels a new infection has occurred, the results of which will be used by an endpoint review committee, blinded to the allocated arm and independent of patient care, to determine the primary outcome. All enrolled patients will be followed for mortality and endotracheal tube cuff-related complications at 28 days and 90 days after randomisation. Other secondary outcomes include antibiotic use; days ventilated, in ICU and in hospital

  9. The effectiveness of a preconditioning programme on preventing running-related injuries in novice runners: a randomised controlled trial.

    Science.gov (United States)

    Bredeweg, Steef W; Zijlstra, Sjouke; Bessem, Bram; Buist, Ida

    2012-09-01

    There is no consensus on the aetiology and prevention of running-related injuries in runners. Preconditioning studies among different athlete populations show positive effects on the incidence of sports injuries. A 4-week preconditioning programme in novice runners will reduce the incidence of running-related injuries. Randomised controlled clinical trial; level of evidence, 1. Novice runners (N=432) prepared for a four-mile recreational running event. Participants were allocated to the 4-week preconditioning (PRECON) group (N=211) or the control group (N=221). The PRECON group started a 4-week training programme, prior to the running programme, with walking and hopping exercises. After the 4-week period both groups started a 9-week running programme. In both groups information was registered on running exposure and running-related injuries (RRIs) using an internet-based running log. Primary outcome measure was RRIs per 100 runners. An RRI was defined as any musculoskeletal complaint of the lower extremity or lower back causing restriction of running for at least a week. The incidence of RRIs was 15.2% in the PRECON group and 16.8% in the control group. The difference in RRIs between the groups was not significant (χ(2)=0.161, df=1, p=0.69). This prospective study demonstrated that a 4-week PRECON programme with walking and hopping exercises had no influence on the incidence of RRIs in novice runners.

  10. Fracture fixation in the operative management of hip fractures (FAITH) : an international, multicentre, randomised controlled trial

    NARCIS (Netherlands)

    Nauth, Aaron; Creek, Aaron T.; Zellar, Abby; Lawendy, Abdel Rahman; Dowrick, Adam; Gupta, Ajay; Dadi, Akhil; van Kampen, Albert; Yee, Albert; de Vries, Alexander C.; de Mol van Otterloo, Alexander; Garibaldi, Alisha; Liew, Allen; McIntyre, Allison W.; Prasad, Amal Shankar; Romero, Amanda W.; Rangan, Amar; Oatt, Amber; Sanghavi, Amir; Foley, Amy L.; Karlsten, Anders; Dolenc, Andrea; Bucknill, Andrew; Chia, Andrew; Evans, Andrew; Gong, Andrew; Schmidt, Andrew H.; Marcantonio, Andrew J.; Jennings, Andrew; Ward, Angela; Khanna, Angshuman; Rai, Anil; Smits, Anke B; Horan, Annamarie D.; Brekke, Anne Christine; Flynn, Annette; Duraikannan, Aravin; Stødle, Are; van Vugt, Arie B.; Luther, Arlene; Zurcher, Arthur W.; Jain, Arvind; Amundsen, Asgeir; Moaveni, Ash; Carr, Ashley; Sharma, Ateet; Hill, Austin D.; Trommer, Axel; Rai, B. Sachidananda; Hileman, Barbara; Schreurs, Bart; Verhoeven, Bart A N; Barden, Benjamin B.; Flatøy, Bernhard; Cleffken, Berry I.; Bøe, Berthe; Perey, Bertrand; Hanusch, Birgit C.; Weening, Brad; Fioole, Bram; Rijbroek, Bram; Crist, Brett D.; Halliday, Brett; Peterson, Brett; Mullis, Brian; Richardson, C. Glen; Clark, Callum; Sagebien, Carlos A.; van der Pol, Carmen C.; Bowler, Carol; Humphrey, Catherine A.; Coady, Catherine; Koppert, Cees L.; Coles, Chad; Tannoury, Chadi; DePaolo, Charles J.; Gayton, Chris; Herriott, Chris; Reeves, Christina; Tieszer, Christina; Dobb, Christine; Anderson, Christopher G.; Sage, Claire; Cuento, Claudine; Jones, Clifford B.; Bosman, Coks H.R.; Linehan, Colleen; van der Hart, Cor P.; Henderson, Corey; Lewis, Courtland G.; Davis, Craig A.; Donohue, Craig; Mauffrey, Cyril; Sundaresh, D. C.; Farrell, Dana J.; Whelan, Daniel B.; Horwitz, Daniel; Stinner, Daniel; Viskontas, Darius; Roffey, Darren M.; Alexander, David; Karges, David E.; Hak, David; Johnston, David; Love, David; Wright, David M.; Zamorano, David P.; Goetz, David R.; Sanders, David; Stephen, David; Yen, David; Bardana, Davide; Olakkengil, Davy J.; Lawson, Deanna; Maddock, Deborah; Sietsema, Debra L.; Pourmand, Deeba; Den Hartog, Dennis; Donegan, Derek; Heels-Ansdell, Diane; Nam, Diane; Inman, Dominic; Boyer, Dory; Li, Doug; Gibula, Douglas; Price, Dustin M.; Watson, Dylan J.; Hammerberg, E. Mark; Tan, Edward C T H; de Graaf, Eelco J.R.; Vesterhus, Elise Berg; Roper, Elizabeth; Edwards, Elton; Schemitsch, Emil H.; Hammacher, Eric R.; Henderson, Eric R.; Whatley, Erica; Torres, Erick T.; Vermeulen, Erik G.J.; Finn, Erin; Van Lieshout, Esther M M; Wai, Eugene K.; Bannister, Evan R.; Kile, Evelyn; Theunissen, Evert B.M.; Ritchie, Ewan D.; Khan, Farah; Moola, Farhad; Howells, Fiona; de Nies, Frank; van der Heijden, Frank H.W.M.; de Meulemeester, Frank R.A.J.; Frihagen, Frede; Nilsen, Fredrik; Schmidt, G. Ben; Albers, G. H.Robert; Gudger, Garland K.; Johnson, Garth; Gruen, Gary; Zohman, Gary; Sharma, Gaurav; Wood, Gavin; Tetteroo, Geert W.M.; Hjorthaug, Geir; Jomaas, Geir; Donald, Geoff; Rieser, Geoffrey Ryan; Reardon, Gerald; Slobogean, Gerard P.; Roukema, Gert R.; Visser, Gijs A.; Moatshe, Gilbert; Horner, Gillian; Rose, Glynis; Guyatt, Gordon; Chuter, Graham; Etherington, Greg; Rocca, Gregory J.Della; Ekås, Guri; Dobbin, Gwendolyn; Lemke, H. Michael; Curry, Hamish; Boxma, Han; Gissel, Hannah; Kreder, Hans; Kuiken, Hans; Brom, Hans L.F.; Pape, Hans Christoph; van der Vis, Harm M.; Bedi, Harvinder; Vallier, Heather A.; Brien, Heather; Silva, Heather; Newman, Heike; Viveiros, Helena; van der Hoeven, Henk; Ahn, Henry; Johal, Herman; Rijna, Herman; Stockmann, Heyn; Josaputra, Hong A.; Carlisle, Hope; van der Brand, Igor; Dawson, Imro; Tarkin, Ivan; Wong, Ivan; Parr, J. Andrew; Trenholm, J. Andrew; Goslings, J Carel; Amirault, J. David; Broderick, J. Scott; Snellen, Jaap P.; Zijl, Jacco A.C.; Ahn, Jaimo; Ficke, James; Irrgang, James; Powell, James; Ringler, James R.; Shaer, James; Monica, James T.; Biert, Jan; Bosma, Jan; Brattgjerd, Jan Egil; Frölke, Jan Paul M.; Wille, Jan; Rajakumar, Janakiraman; Walker, Jane E.; Baker, Janell K.; Ertl, Janos P.; De Vries, Jean-Paul P. M.; Gardeniers, Jean W.M.; May, Jedediah; Yach, Jeff; Hidy, Jennifer T.; Westberg, Jerald R.; Hall, Jeremy A.; van Mulken, Jeroen; McBeth, Jessica Cooper; Hoogendoorn, Jochem M; Hoffman, Jodi M.; Cherian, Joe Joseph; Tanksley, John A.; Clarke-Jenssen, John; Adams, John D.; Esterhai, John; Tilzey, John F.; Murnaghan, John; Ketz, John P.; Garfi, John S.; Schwappach, John; Gorczyca, John T.; Wyrick, John; Rydinge, Jonas; Foret, Jonathan L.; Gross, Jonathan M.; Keeve, Jonathan P.; Meijer, Joost; Scheepers, Joris J.G.; Baele, Joseph; O'Neil, Joseph; Cass, Joseph R.; Hsu, Joseph R.; Dumais, Jules; Lee, Julia; Switzer, Julie A.; Agel, Julie; Richards, Justin E.; Langan, Justin W.; Turckan, Kahn; Pecorella, Kaili; Rai, Kamal; Aurang, Kamran; Shively, Karl; van Wessem, Karlijn; Moon, Karyn; Eke, Kate; Erwin, Katie; Milner, Katrine; Ponsen, Kees Jan; Mills, Kelli; Apostle, Kelly; Johnston, Kelly; Trask, Kelly; Strohecker, Kent; Stringfellow, Kenya; Kruse, Kevin K.; Tetsworth, Kevin; Mitchell, Khalis; Browner, Kieran; Hemlock, Kim; Carcary, Kimberly; Jørgen Haug, Knut; Noble, Krista; Robbins, Kristin; Payton, Krystal; Jeray, Kyle J.; Rubino, L. Joseph; Nastoff, Lauren A.; Leffler, Lauren C.; Stassen, Laurents P.S.; O'Malley, Lawrence K.; Specht, Lawrence M.; Thabane, Lehana; Geeraedts, Leo M.G.; Shell, Leslie E.; Anderson, Linda K.; Eickhoff, Linda S.; Lyle, Lindsey; Pilling, Lindsey; Buckingham, Lisa; Cannada, Lisa K.; Wild, Lisa M.; Dulaney-Cripe, Liz; Poelhekke, Lodewijk M.S.J.; Govaert, Lonneke; Ton, Lu; Kottam, Lucksy; Leenen, Luke P.H.; Clipper, Lydia; Jackson, Lyle T.; Hampton, Lynne; de Waal Malefijt, Maarten C.; Simons, Maarten P.; van der Elst, Maarten; Bronkhorst, Maarten W.G.A.; Bhatia, Mahesh; Swiontkowski, Marc; Lobo, Margaret J.; Swinton, Marilyn; Pirpiris, Marinis; Molund, Marius; Gichuru, Mark; Glazebrook, Mark; Harrison, Mark; Jenkins, Mark; MacLeod, Mark; de Vries, Mark R.; Butler, Mark S.; Nousiainen, Markku; van ‘t Riet, Martijne; Tynan, Martin C.; Campo, Martin; Eversdijk, Martin G.; Heetveld, Martin J.; Richardson, Martin; Breslin, Mary; Fan, Mary; Edison, Matt; Napierala, Matthew; Knobe, Matthias; Russ, Matthias; Zomar, Mauri; de Brauw, Maurits; Esser, Max; Hurley, Meghan; Peters, Melissa E.; Lorenzo, Melissa; Li, Mengnai; Archdeacon, Michael; Biddulph, Michael; Charlton, Michael R; McDonald, Michael D.; McKee, Michael D.; Dunbar, Michael; Torchia, Michael E.; Gross, Michael; Hewitt, Michael; Holt, Michael; Prayson, Michael J.; Edwards, Michael J R; Beckish, Michael L.; Brennan, Michael L.; Dohm, Michael P.; Kain, Michael S.H.; Vogt, Michelle; Yu, Michelle; Verhofstad, Michiel H J; Segers, Michiel J M; Segers, Michiel J M; Siroen, Michiel P.C.; Reed, Mike; Vicente, Milena R.; Bruijninckx, Milko M.M.; Trivedi, Mittal; Bhandari, Mohit; Moore, Molly M.; Kunz, Monica; Smedsrud, Morten; Palla, Naveen; Jain, Neeraj; Out, Nico J.M.; Simunovic, Nicole; Simunovic, Nicole; Schep, Niels W. L.; Müller, Oliver; Guicherit, Onno R.; Van Waes, Oscar J.F.; Wang, Otis; Doornebosch, Pascal G.; Seuffert, Patricia; Hesketh, Patrick J.; Weinrauch, Patrick; Duffy, Paul; Keller, Paul; Lafferty, Paul M.; Pincus, Paul; Tornetta, Paul; Zalzal, Paul; McKay, Paula; Cole, Peter A.; de Rooij, Peter D.; Hull, Peter; Go, Peter M.N.Y.M.; Patka, Peter; Siska, Peter; Weingarten, Peter; Kregor, Philip; Stahel, Philip; Stull, Philip; Wittich, Philippe; de Rijcke, Piet A.R.; Oprel, Pim; Devereaux, P. J.; Zhou, Qi; Lee Murphy, R.; Alosky, Rachel; Clarkson, Rachel; Moon, Raely; Logishetty, Rajanikanth; Nanda, Rajesh; Sullivan, Raymond J.; Snider, Rebecca G.; Buckley, Richard E.; Iorio, Richard; Farrugia, Richard J.; Jenkinson, Richard; Laughlin, Richard; Groenendijk, Richard P R; Gurich, Richard W.; Worman, Ripley; Silvis, Rob; Haverlag, Robert; Teasdall, Robert J.; Korley, Robert; McCormack, Robert; Probe, Robert; Cantu, Robert V.; Huff, Roger B.; Simmermacher, Rogier K J; Peters, Rolf; Pfeifer, Roman; Liem, Ronald; Wessel, Ronald N.; Verhagen, Ronald; Vuylsteke, Ronald J C L M; Leighton, Ross; McKercher, Ross; Poolman, Rudolf W; Miller, Russell; Bicknell, Ryan; Finnan, Ryan; Khan, Ryan M.; Mehta, Samir; Vang, Sandy; Singh, Sanjay; Anand, Sanjeev; Anderson, Sarah A.; Dawson, Sarah A.; Marston, Scott B.; Porter, Scott E.; Watson, Scott T.; Festen, Sebastiaan; Lieberman, Shane; Puloski, Shannon; Bielby, Shea A.; Sprague, Sheila; Hess, Shelley; MacDonald, Shelley; Evans, Simone; Bzovsky, Sofia; Hasselund, Sondre; Lewis, Sophie; Ugland, Stein; Caminiti, Stephanie; Tanner, Stephanie L.; Zielinski, Stephanie M.; Shepard, Stephanie; Sems, Stephen A.; Walter, Stephen D.; Doig, Stephen; Finley, Stephen H.; Kates, Stephen; Lindenbaum, Stephen; Kingwell, Stephen P.; Csongvay, Steve; Papp, Steve; Buijk, Steven E.; Rhemrev, Steven J.; Hollenbeck, Steven M.; van Gaalen, Steven M.; Yang, Steven; Weinerman, Stuart; Lambert, Sue; Liew, Susan; Meylaerts, Sven A.G.; Blokhuis, Taco J.; de Vries Reilingh, Tammo S.; Lona, Tarjei; Scott, Taryn; Swenson, Teresa K.; Endres, Terrence J.; Axelrod, Terry; van Egmond, Teun; Pace, Thomas B.; Kibsgård, Thomas; Schaller, Thomas M.; Ly, Thuan V.; Miller, Timothy J.; Weber, Timothy; Le, Toan; Oliver, Todd M.; Karsten, Tom M.; Borch, Tor; Hoseth, Tor Magne; Nicolaisen, Tor; Ianssen, Torben; Rutherford, Tori; Nanney, Tracy; Gervais, Trevor; Stone, Trevor; Schrickel, Tyson; Scrabeck, Tyson; Ganguly, Utsav; Naumetz, V.; Frizzell, Valda; Wadey, Veronica; Jones, Vicki; Avram, Victoria; Mishra, Vimlesh; Yadav, Vineet; Arora, Vinod; Tyagi, Vivek; Borsella, Vivian; Willems, W. Jaap; Hoffman, W. H.; Gofton, Wade T.; Lackey, Wesley G.; Ghent, Wesley; Obremskey, William; Oxner, William; Cross, William W.; Murtha, Yvonne M.; Murdoch, Zoe

    2017-01-01

    Background Reoperation rates are high after surgery for hip fractures. We investigated the effect of a sliding hip screw versus cancellous screws on the risk of reoperation and other key outcomes. Methods For this international, multicentre, allocation concealed randomised controlled trial, we

  11. Efecto de la adición de materia orgánica sobre la dinámica poblacional bacteriana del suelo en cultivos de papa y maíz

    Directory of Open Access Journals (Sweden)

    David García Ventocilla

    2012-02-01

    Full Text Available Se determinó el efecto de la fertilización orgánica sobre las poblaciones bacterianas del suelo en cultivos de papa y maíz durante la campaña agrícola 2008-2009 en terrenos de cuatro localidades del Valle del Mantaro: INIA Santa Ana (Huancayo, en la EEA El Mantaro (Jauja, Vista Alegre y Huayao (ambos en Chupaca. En estos lugares se instalaron parcelas experimentales de papa (Solanum tuberosum L. Var. Canchan y maíz (Zea maíz L. Var. Cusco mejorado bajo abonamiento orgánico (vacuno, ovino, cuy, fertilización química y sin fertilización alguna (testigo. Para dicho efecto se empleó las técnicas de la Electroforesis en Gel de Gradiente Desnaturalizante (DGGE con amplificación de la región 968 – 1401 del rDNA 16S. Los resultados obtenidos muestran que la variabilidad de las poblaciones bacterianas en los suelos está afectado directamente por el tipo de cultivo mas no por el tipo de fertilización ya que el efecto de este último resulta variable para cada zona experimental y cultivo encontrándose solo en la zona experimental de Chupaca - Maíz una segregación de los tratamientos con fertilización orgánica de los tratamientos químicos. También se ha encontrado que la variación de las comunidades microbianas no sufre variaciones significativas en los suelos con cultivos de maíz obteniéndose coeficientes de similaridad para todos los tratamientos por encima del 80% mientras que para los tratamientos en los cultivos de papa dicho coeficiente fue de tan solo del 60%.

  12. An internet-based intervention with brief nurse support to manage obesity in primary care (POWeR+): a pragmatic, parallel-group, randomised controlled trial.

    Science.gov (United States)

    Little, Paul; Stuart, Beth; Hobbs, Fd Richard; Kelly, Jo; Smith, Emily R; Bradbury, Katherine J; Hughes, Stephanie; Smith, Peter W F; Moore, Michael V; Lean, Mike E J; Margetts, Barrie M; Byrne, Chris D; Griffin, Simon; Davoudianfar, Mina; Hooper, Julie; Yao, Guiqing; Zhu, Shihua; Raftery, James; Yardley, Lucy

    2016-10-01

    The obesity epidemic has major public health consequences. Expert dietetic and behavioural counselling with intensive follow-up is effective, but resource requirements severely restrict widespread implementation in primary care, where most patients are managed. We aimed to estimate the effectiveness and cost-effectiveness of an internet-based behavioural intervention (POWeR+) combined with brief practice nurse support in primary care. We did this pragmatic, parallel-group, randomised controlled trial at 56 primary care practices in central and south England. Eligible adults aged 18 years or older with a BMI of 30 kg/m(2) or more (or ≥28 kg/m(2) with hypertension, hypercholesterolaemia, or diabetes) registered online with POWeR+-a 24 session, web-based, weight management intervention lasting 6 months. After registration, the website automatically randomly assigned patients (1:1:1), via computer-generated random numbers, to receive evidence-based dietetic advice to swap foods for similar, but healthier, choices and increase fruit and vegetable intake, in addition to 6 monthly nurse follow-up (control group); web-based intervention and face-to-face nurse support (POWeR+Face-to-face [POWeR+F]; up to seven nurse contacts over 6 months); or web-based intervention and remote nurse support (POWeR+Remote [POWeR+R]; up to five emails or brief phone calls over 6 months). Participants and investigators were masked to group allocation at the point of randomisation; masking of participants was not possible after randomisation. The primary outcome was weight loss averaged over 12 months. We did a secondary analysis of weight to measure maintenance of 5% weight loss at months 6 and 12. We modelled the cost-effectiveness of each intervention. We did analysis by intention to treat, with multiple imputation for missing data. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN21244703. Between Jan 30, 2013, and March 20, 2014, 818

  13. Halı Sektöründe İhracat Yapan Firmaların Markalaşma Düzeylerinin

    Directory of Open Access Journals (Sweden)

    Mustafa METE

    2017-07-01

    Full Text Available Dış pazarlar, tehditleri ve fırsatları bünyesinde barındırmanın yanı sıra ulusal sınırlarla yetinmeyerek tüm dünyada adından söz ettirmek isteyen firmaların riskleri göze alarak zorlu rekabet ortamı içerisine girdikleri tespit edilmiştir. Markalaşma üzerine ülkemizdeki çalışmaların sayısının oldukça yetersiz olduğu, özellikle halı sektöründe ise daha az olduğu görülmektedir. Bu çalışmada Türk ekonomisinde önemli bir yere sahip olan halı sektörü ihracatında markalaşmanın etkilerinin tespit edilmesi amaçlanmıştır. Bu amaç doğrultusunda Gaziantep ilinde faaliyet göstermekte olan ve ihracat yapan halı firmaları üzerinde çalışma gerçekleştirilmiştir. Çalışmaya toplam 50 firma dahil edilmiştir. Veriler anket yöntemiyle elde edilmiştir. Çalışmadan elde edilen verilerin analizi SPSS 16.0 programı ile yapılmıştır. Yapılan analizler neticesinde bir marka adı altında ihracat yapan firmaların ihracat performansının daha yüksek olduğu, Turquality desteği alan firmaların son 3 yıllık ihracat ve satış performansının daha yüksek olduğu tespit edilmiştir.

  14. Patch: platelet transfusion in cerebral haemorrhage: study protocol for a multicentre, randomised, controlled trial

    Directory of Open Access Journals (Sweden)

    Dijkgraaf Marcel G

    2010-03-01

    Full Text Available Abstract Background Patients suffering from intracerebral haemorrhage have a poor prognosis, especially if they are using antiplatelet therapy. Currently, no effective acute treatment option for intracerebral haemorrhage exists. Limiting the early growth of intracerebral haemorrhage volume which continues the first hours after admission seems a promising strategy. Because intracerebral haemorrhage patients who are on antiplatelet therapy have been shown to be particularly at risk of early haematoma growth, platelet transfusion may have a beneficial effect. Methods/Design The primary objective is to investigate whether platelet transfusion improves outcome in intracerebral haemorrhage patients who are on antiplatelet treatment. The PATCH study is a prospective, randomised, multi-centre study with open treatment and blind endpoint evaluation. Patients will be randomised to receive platelet transfusion within six hours or standard care. The primary endpoint is functional health after three months. The main secondary endpoints are safety of platelet transfusion and the occurrence of haematoma growth. To detect an absolute poor outcome reduction of 20%, a total of 190 patients will be included. Discussion To our knowledge this is the first randomised controlled trial of platelet transfusion for an acute haemorrhagic disease. Trial registration The Netherlands National Trial Register (NTR1303

  15. Fusidic acid cream in the treatment of impetigo in general practice: double blind randomised placebo controlled trial

    NARCIS (Netherlands)

    S. Koning (Sander); L.W.A. van Suijlekom-Smit (Lisette); J.L. Nouwen (Jan); C.M. Verduin (Cees); R.M.D. Bernsen (Roos); A.P. Oranje (Arnold); S. Thomas (Siep); J.C. van der Wouden (Hans)

    2002-01-01

    textabstractOBJECTIVE: To test the hypothesis that fusidic acid would not increase the treatment effect of disinfecting with povidone-iodine alone in children with impetigo. DESIGN: Randomised placebo controlled trial. SETTING: General practices in Greater Rotterdam.

  16. Simplified sleep restriction for insomnia in general practice: a randomised controlled trial.

    Science.gov (United States)

    Falloon, Karen; Elley, C Raina; Fernando, Antonio; Lee, Arier C; Arroll, Bruce

    2015-08-01

    Insomnia is common in primary care. Cognitive behavioural therapy for insomnia (CBT-I) is effective but requires more time than is available in the general practice consultation. Sleep restriction is one behavioural component of CBT-I. To assess whether simplified sleep restriction (SSR) can be effective in improving sleep in primary insomnia. Randomised controlled trial of patients in urban general practice settings in Auckland, New Zealand. Adults with persistent primary insomnia and no mental health or significant comorbidity were eligible. Intervention patients received SSR instructions and sleep hygiene advice. Control patients received sleep hygiene advice alone. Primary outcomes included change in sleep quality at 6 months measured by the Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), and sleep efficiency (SE%). The proportion of participants reaching a predefined 'insomnia remission' treatment response was calculated. Ninety-seven patients were randomised and 94 (97%) completed the study. At 6-month follow-up, SSR participants had improved PSQI scores (6.2 versus 8.4, Pinsomnia, the adjusted odds ratio for insomnia remission was 2.7 (95% CI = 1.1 to 6.5). There were no significant differences in other outcomes or adverse effects. SSR is an effective brief intervention in adults with primary insomnia and no comorbidities, suitable for use in general practice. © British Journal of General Practice 2015.

  17. The Impact of motivational interviewing on illness perception in patients with stable coronary artery disease. A randomised controlled study

    Science.gov (United States)

    Mülhauser, Sara; Bonhôte Börner, Martine; Saner, Hugo; Zumstein-Shaha, Maya

    2018-04-01

    Background: Coronary heart disease (CHD) constitutes one of the most frequent causes of death for individuals > 60 years. Lifestyle dependent risk factors are key. Hence, cardiac rehabilitation is essential for optimal CHD treatment. However, individuals rarely comprehend their illness. Motivational interviewing promotes illness perception. Aim/Methods: A randomised-controlled study was conducted to determine the effect of motivational interviewing on illness perception. Patients with stable coronary heart disease were consecutively recruited after elective percutaneous transluminal coronary angioplasty (PTCA). The intervention group received a short motivational interview (MI) about the disease and related risk factors as an intervention. The control group had usual treatment. Illness perception was assessed (Illness Perception Questionnaire-Revised) prior to the intervention and six months afterwards. Results: A total of 312 patients (intervention group: n = 148, control group: n = 164) were recruited into the study (mean age: 66.2 years). After the intervention, a significant change was observed in the domain of emotional reactions regarding the disease. Conclusion: To improve illness perception in patients with stable CHD, one short intervention with MI may have an effect. Whether intensifying the MI-intervention is more effective, requires further research.

  18. Persistent occiput posterior: OUTcomes following digital rotation: a pilot randomised controlled trial.

    Science.gov (United States)

    Graham, Kathryn; Phipps, Hala; Hyett, Jon A; Ludlow, Joanne P; Mackie, Adam; Marren, Anthony; De Vries, Bradley

    2014-06-01

    To determine the feasibility of a multicentre randomised controlled trial (RCT) to investigate whether digital rotation of the fetal head from occiput posterior (OP) position in the second stage of labour reduces the risk of operative delivery (defined as caesarean section (CS) or instrumental delivery). We conducted the study between December 2010 and December 2011 in a tertiary referral hospital in Australia. A transabdominal ultrasound was performed early in the second stage of labour on women with cephalic, singleton pregnancies to determine the fetal position. Those women with a fetus in the OP position were randomised to either a digital rotation or a sham procedure. In all other ways, participants received their usual intrapartum care. Data regarding demographics, mode of delivery, labour, post natal period and neonatal outcomes were collected. One thousand and four women were consented, 834 achieved full dilatation, and 30 were randomised. An additional portable ultrasound scan and a blinded 'sham' digital rotation were acceptable to women and staff. Operative delivery rates were 13/15 in the digital rotation (four CS and nine instrumental) and 12/15 in the sham (three CS and nine instrumental) groups, respectively. A large double-blinded multicentre RCT would be feasible and acceptable to women and staff. Strategies to improve recruitment such as consenting women with an effective epidural in active labour should be considered. This would be the first RCT to answer a clinically important question which could significantly affect the operative delivery rate in Australia and internationally. © 2014 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

  19. Ma

    Directory of Open Access Journals (Sweden)

    Ingrid Berthon-Moine

    2012-01-01

    Full Text Available Ma (2009 is a single channel video of a mother and child walking together side by side, holding hands. The title is reminiscent of the affectionate nickname for a mother, 'Ma', but also a concealed way to convey maternal ambivalence. Maternal ambivalence is the result of the tension between the idealisation of motherhood and women’s lived experience of mothering. The maternal struggle finds its source in the difficulty of identifying with the ideological representation of the mother. This image still conveys an idealistic and nostalgic, patriarchal image of maternal love bounded by culture and history. http://podcast.ulcc.ac.uk/accounts/BirkbeckCollege/mamsie/MA.mov

  20. A multi-centre randomised controlled trial of rehabilitation aimed at improving outdoor mobility for people after stroke: Study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Logan Pip A

    2012-06-01

    Full Text Available Abstract Background Up to 42% of all stroke patients do not get out of the house as much as they would like. This can impede a person’s quality of life. This study is testing the clinical effectiveness and cost effectiveness of a new outdoor mobility rehabilitation intervention by comparing it to usual care. Methods/design This is a multi-centre parallel group individually randomised, controlled trial. At least 506 participants will be recruited through 15 primary and secondary care settings and will be eligible if they are over 18 years of age, have had a stroke and wish to get out of the house more often. Participants are being randomly allocated to either the intervention group or the control group. Intervention group participants receive up to 12 rehabilitation outdoor mobility sessions over up to four months. The main component of the intervention is repeated practice of outdoor mobility with a therapist. Control group participants are receiving the usual intervention for outdoor mobility limitations: verbal advice and provision of leaflets provided over one session. Outcome measures are being collected using postal questionnaires, travel calendars and by independent assessors. The primary outcome measure is the Social Function domain of the SF36v2 quality of life assessment six months after recruitment. The secondary outcome measures include: functional ability, mobility, the number of journeys (monthly travel diaries, satisfaction with outdoor mobility, mood, health-related quality of life, resource use of health and social care. Carer mood information is also being collected. The mean Social Function score of the SF-36v2 will be compared between treatment arms using a multiple membership form of mixed effects multiple regression analysis adjusting for centre (as a fixed effect, age and baseline Social Function score as covariates and therapist as a multiple membership random effect. Regression coefficients and 95% confidence

  1. 42 CFR 422.4 - Types of MA plans.

    Science.gov (United States)

    2010-10-01

    ... availability, service area, and quality. (ii) Coordinated care plans may include mechanisms to control... requirements of sections 138 and 220 of the Internal Revenue Code. (3) MA private fee-for-service plan. An MA... Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED...

  2. Efecto de la amonificación sobre el valor nutritivo del ensilaje de maíz

    OpenAIRE

    Pabón P., Ricardo A.; Toro B., J. Omar; Sánchez G., Hugo

    2010-01-01

    Mediante la técnica del microsilo, se midió el efecto de niveles de 0, 1, 2 y 3% de NH3 en base a la materia seca sobre el ensilaje de maíz con y sin mazorca. Las variables medidas fueron pH, temperatura, contenido de materia seca (%), contenido de proteína cruda (%), degradabilidad insitu de la materia seca y de la proteína cruda (%) a 48 horas de incubación ruminal. Los resultados muestran el efecto benéfico de la amonificación sobre la estabilidad del ensilaje y sobre su valor nutritivo. E...

  3. Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers

    NARCIS (Netherlands)

    O’Cathain, A.; Hoddinott, P.; Lewin, S.; Thomas, K.J.; Young, B.; Adamson, J.; Jansen, J.F.M.; Mills, N.; Moore, G.; Donovan, J.L.

    2015-01-01

    Feasibility studies are increasingly undertaken in preparation for randomised controlled trials in order to explore uncertainties and enable trialists to optimise the intervention or the conduct of the trial. Qualitative research can be used to examine and address key uncertainties prior to a full

  4. Fenología productiva y nutricional de maíz para la producción de forraje

    Directory of Open Access Journals (Sweden)

    Ana Lorena Amador R.

    2000-01-01

    Full Text Available Fenología productiva y nutricional de maíz para la producción de forraje. El experimento se llevó a cabo en la Estación Experimental “Alfredo Volio Mata” de la Universidad de Costa Rica. Se empleó semilla de maíz criolla forrajera. Alos 37 días de edad se realizó el primer muestreo de plantas y los siguientes se efectuaron cada 14 días hasta los 149 días de edad. Se determinó el contenido de materia seca, la proteína cruda, las cenizas totales, la fibra neutro detergente (FND, la fibra ácido detergente (FAD y la lignina así como los valores de hemicelulosa y celulosa. Antes de los 65 días de crecimiento, la producción de hojas fue superior a la de tallo. Posterior a esta edad, la planta fue mayor productora de tallo. Las flores emergieron después de los 100 días y ellas tuvieron un alto contenido de materia seca, contribuyendo poco en el rendimiento global del cultivo. Alos 120 días, la producción de materia seca en las mazorcas fue ligeramente mayor a la acumulada por las hojas. El contenido de materia seca en el tallo, antes de los 120 días, y en la hoja antes de los 80 días fue bajo, para ser empleado como forraje en la alimentación del ganado. El contenido de proteína cruda comenzó a decrecer drásticamente a los 65 días en el tallo y a los 90 días en la hoja. Sólo en los primeros 50 días de crecimiento, la pared celular de los tallos fue menor a 50%. El contenido de cenizas fue mayor en el tallo que en la hoja en los primeros 90 días. Por las cualidades fenológicas observadas y la concentración de nutrientes en tallos y hojas, se recomienda la cosecha y el aprovechamiento del forraje de maíz entre 80 y 90 días de crecimiento. En edades posteriores, se puede obtener el beneficio de un mayor tonelaje por unidad de superficie, sacrificando la calidad nutricional

  5. Exercise and manual auricular acupuncture: a pilot assessor-blind randomised controlled trial. (The acupuncture and personalised exercise programme (APEP Trial

    Directory of Open Access Journals (Sweden)

    Hurley D

    2008-03-01

    Full Text Available Abstract Background Evidence supports the use of exercise for chronic low back pain (CLBP; however, adherence is often poor due to ongoing pain. Auricular acupuncture is a form of pain relief involving the stimulation of points on the outer ear corresponding with specific body parts. It may be a useful adjunct to exercise in managing CLBP; however, there is only limited evidence to support its use with this patient group. Methods/Design This study was designed to test the feasibility of an assessor-blind randomised controlled trial which assess the effects on clinical outcomes and exercise adherence of adding manual auricular acupuncture to a personalised and supervised exercise programme (PEP for CLBP. No sample size calculation has been carried out as this study aims to identify CLBP referral rates within the catchment area of the study site. The researchers aim to recruit four cohorts of n = 20 participants to facilitate a power analysis for a future randomised controlled trial. A computer generated random allocation sequence will be prepared centrally and used to allocate participants by cohort to one of the following interventions: 1 six weeks of PEP plus manual auricular acupuncture; 2 six weeks of PEP alone. Both groups will also complete a further six weeks of self-paced exercise with telephone follow-up support. In addition to a baseline and exit questionnaire at the beginning and end of the study, the following outcomes will be collected at baseline, and after 7, 13 and 25 weeks: pain frequency and bothersomeness, back-specific function, objective assessment and recall of physical activity, use of analgesia, perceived self-efficacy, fear avoidance beliefs, and beliefs about the consequences of back pain. Since this is a feasibility study, significance tests will not be presented, and treatment effects will be represented by point estimates and confidence intervals. For each outcome variable, analysis of covariance will be performed on

  6. Ear acupuncture or local anaesthetics as pain relief during postpartum surgical repair: a randomised controlled trial

    DEFF Research Database (Denmark)

    Kindberg, S; Klünder, L; Strøm, J

    2009-01-01

    -hour hands-on training in the use of ear acupuncture. All midwives (n= 36) in the department had previous experience in using acupuncture for obstetric pain relief. Pain and wound healing were evaluated using validated scores. Data collection was performed by research assistants blinded towards...... treatment allocation. Randomisation was computer assisted. A total of 207 women were randomised to receive ear acupuncture (105) and local anaesthetics (102), respectively. Main outcome measures The primary outcome was pain during surgical repair. Secondary outcomes were wound healing at 24-48 hours and 14...... days postpartum, participant satisfaction, revision of wound or dyspareunia reported 6 months postpartum. Results Pain during surgical repair was more frequently reported by participants allocated to ear acupuncture compared with participants receiving local anaesthetics (89 versus 54%, P

  7. Reading and language intervention for children at risk of dyslexia: a randomised controlled trial.

    Science.gov (United States)

    Duff, Fiona J; Hulme, Charles; Grainger, Katy; Hardwick, Samantha J; Miles, Jeremy N V; Snowling, Margaret J

    2014-11-01

    Intervention studies for children at risk of dyslexia have typically been delivered preschool, and show short-term effects on letter knowledge and phoneme awareness, with little transfer to literacy. This randomised controlled trial evaluated the effectiveness of a reading and language intervention for 6-year-old children identified by research criteria as being at risk of dyslexia (n = 56), and their school-identified peers (n = 89). An Experimental group received two 9-week blocks of daily intervention delivered by trained teaching assistants; the Control group received 9 weeks of typical classroom instruction, followed by 9 weeks of intervention. Following mixed effects regression models and path analyses, small-to-moderate effects were shown on letter knowledge, phoneme awareness and taught vocabulary. However, these were fragile and short lived, and there was no reliable effect on the primary outcome of word-level reading. This new intervention was theoretically motivated and based on previous successful interventions, yet failed to show reliable effects on language and literacy measures following a rigorous evaluation. We suggest that the intervention may have been too short to yield improvements in oral language; and that literacy instruction in and beyond the classroom may have weakened training effects. We argue that reporting of null results makes an important contribution in terms of raising standards both of trial reporting and educational practice. © 2014 The Authors. Journal of Child Psychology and Psychiatry published by John Wiley & Sons Ltd on behalf of Association for Child and Adolescent Mental Health.

  8. Increasing walking in patients with intermittent claudication: Protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    O'Carroll Ronan E

    2010-10-01

    Full Text Available Abstract Background People with intermittent claudication are at increased risk of death from heart attack and stroke compared to matched controls. Surgery for intermittent claudication is for symptom management and does not reduce the risk of cardiovascular morbidity and mortality. Increasing physical activity can reduce claudication symptoms and may improve cardiovascular health. This paper presents the pilot study protocol for a randomised controlled trial to test whether a brief psychological intervention leads to increased physical activity, improvement in quality of life, and a reduction in the demand for surgery, for patients with intermittent claudication. Methods/Design We aim to recruit 60 patients newly diagnosed with intermittent claudication, who will be randomised into two groups. The control group will receive usual care, and the treatment group will receive usual care and a brief 2-session psychological intervention to modify illness and walking beliefs and develop a walking action plan. The primary outcome will be walking, measured by pedometer. Secondary outcomes will include quality of life and uptake of surgery for symptom management. Participants will be followed up after (a 4 months, (b 1 year and (c 2 years. Discussion This study will assess the acceptability and efficacy of a brief psychological intervention to increase walking in patients with intermittent claudication, both in terms of the initiation, and maintenance of behaviour change. This is a pilot study, and the results will inform the design of a larger multi-centre trial. Trial Registration Current Controlled Trials ISRCTN28051878

  9. Functional exercise after total hip replacement (FEATHER a randomised control trial

    Directory of Open Access Journals (Sweden)

    Monaghan Brenda

    2012-11-01

    Full Text Available Abstract Background Prolonged physical impairments in range of movement, postural stability and walking speed are commonly reported following total hip replacement (THR. It is unclear from the current body of evidence what kind of exercises should be performed to maximize patient function and quality of life. Methods/design This will be a single blind multi centre randomized control trial with two arms. Seventy subjects post primary total hip arthroplasty will be randomized into either an experimental group (n=35, or to a control group (n=35. The experimental group will attend a functional exercise class twice weekly for a six week period from week 12 to week 18 post surgery. The functional exercise group will follow a circuit based functional exercise class supervised by a chartered Physiotherapist. The control group will receive usual care. The principal investigator (BM will perform blinded outcome assessments on all patients using validated measures for pain, stiffness, and function using the Western Ontario and Mc Master Universities Osteoarthritis index (WOMAC. This is the primary outcome measurement tool. Secondary outcome measurements include Quality of life (SF-36, 6 min walk test, Visual Analogue Scale, and the Berg Balance score. The WOMAC score will be collated on day five post surgery and repeated at week twelve and week eighteen. All other measurements will be taken at week 12 and repeated at week eighteen. In addition a blinded radiologist will measure gluteus medius cross sectional area using real time ultrasound for all subjects at week 12 and at week 18 to determine if the functional exercise programme has any effect on muscle size. Discussion This randomised controlled trial will add to the body of evidence on the relationship between muscle size, functional ability, balance, quality of life and time post surgery in patients following total hip arthroplasty. The CONSORT guidelines will be followed to throughout. Ethical

  10. A randomised controlled trial of a lifestyle behavioural intervention for patients with low back pain, who are overweight or obese: study protocol.

    Science.gov (United States)

    Williams, Amanda; Wiggers, John; O'Brien, Kate M; Wolfenden, Luke; Yoong, Serene; Campbell, Elizabeth; Robson, Emma; McAuley, James; Haskins, Robin; Kamper, Steven J; Williams, Christopher M

    2016-02-11

    Low back pain is a highly prevalent condition with a significant global burden. Management of lifestyle factors such as overweight and obesity may improve low back pain patient outcomes. Currently there are no randomised controlled trials that have been conducted to assess the effectiveness of lifestyle behavioural interventions in managing low back pain. The aim of this trial is to determine if a telephone-based lifestyle behavioural intervention is effective in reducing pain intensity in overweight or obese patients with low back pain, compared to usual care. A randomised controlled trial will be conducted with patients waiting for an outpatient consultation with an orthopaedic surgeon at a public tertiary referral hospital within New South Wales, Australia for chronic low back pain. Patients will be randomly allocated in a 1:1 ratio to receive a lifestyle behavioural intervention (intervention group) or continue with usual care (control group). After baseline data collection, patients in the intervention group will receive a clinical consultation followed by a 6-month telephone-based lifestyle behavioural intervention (10 individually tailored sessions over a 6-month period) and patients in the control group will continue with usual care. Participants will be followed for 26 weeks and asked to undertake three self-reported questionnaires at baseline (pre-randomisation), week 6 and 26 post randomisation to collect primary and secondary outcome data. The study requires a sample of 80 participants per group to detect a 1.5 point difference in pain intensity (primary outcome) 26 weeks post randomisation. The primary outcome, pain intensity, will be measured using a 0-10 numerical rating scale. The study will provide robust evidence regarding the effectiveness of a lifestyle behavioural intervention in reducing pain intensity in overweight or obese patients with low back pain and inform management of these patients. Australian New Zealand Clinical Trials Registry

  11. The effectiveness and cost-effectiveness of a mindfulness training programme in schools compared with normal school provision (MYRIAD): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Kuyken, Willem; Nuthall, Elizabeth; Byford, Sarah; Crane, Catherine; Dalgleish, Tim; Ford, Tamsin; Greenberg, Mark T; Ukoumunne, Obioha C; Viner, Russell M; Williams, J Mark G

    2017-04-26

    Mindfulness-based approaches for adults are effective at enhancing mental health, but few controlled trials have evaluated their effectiveness or cost-effectiveness for young people. The primary aim of this trial is to evaluate the effectiveness and cost-effectiveness of a mindfulness training (MT) programme to enhance mental health, wellbeing and social-emotional behavioural functioning in adolescence. To address this aim, the design will be a superiority, cluster randomised controlled, parallel-group trial in which schools offering social and emotional provision in line with good practice (Formby et al., Personal, Social, Health and Economic (PSHE) Education: A mapping study of the prevalent models of delivery and their effectiveness, 2010; OFSTED, Not Yet Good Enough: Personal, Social, Health and Economic Education in schools, 2013) will be randomised to either continue this provision (control) or include MT in this provision (intervention). The study will recruit and randomise 76 schools (clusters) and 5700 school students aged 12 to 14 years, followed up for 2 years. The study will contribute to establishing if MT is an effective and cost-effective approach to promoting mental health in adolescence. International Standard Randomised Controlled Trials, identifier: ISRCTN86619085 . Registered on 3 June 2016.

  12. Evaluación agronómica de maíz tras aplicación de combinaciones de productos de calcio en terrenos ácidos

    OpenAIRE

    Martínez Fernández, A.; Peláez, R.; Argamentería, A.; Soldado, A.; González, A.; Roza Delgado, B. de la

    2012-01-01

    Ponencia presentada a la 51 Reunión Científica de la SEEP celebrada en la Escuela Superior de Ingenieros Agrónomos de la Universidad Pública de Navarra entre el 14 y el 18 de mayo de 2012. El objetivo del presente trabajo ha sido evaluar la eficacia de un encalante granulado formulado con una combinación de CaCO3, CaO, CaMg(CO3)2, sobre el cultivo de maíz forrajero en la zona occidental de Asturias, de tradición maicera, y suelos de naturaleza predominantemente ácida. Para ello, se selecci...

  13. Wordless intervention for people with epilepsy and learning disabilities (WIELD): a randomised controlled feasibility trial

    Science.gov (United States)

    Mengoni, Silvana E; Gates, Bob; Parkes, Georgina; Wellsted, David; Barton, Garry; Ring, Howard; Khoo, Mary Ellen; Monji-Patel, Deela; Friedli, Karin; Zia, Asif; Irvine, Lisa; Durand, Marie-Anne

    2016-01-01

    Objective To investigate the feasibility of a full-scale randomised controlled trial of a picture booklet to improve quality of life for people with epilepsy and learning disabilities. Trial design A randomised controlled feasibility trial. Randomisation was not blinded and was conducted using a centralised secure database and a blocked 1:1 allocation ratio. Setting Epilepsy clinics in 1 English National Health Service (NHS) Trust. Participants Patients with learning disabilities and epilepsy who had: a seizure within the past 12 months, meaningful communication and a carer with sufficient proficiency in English. Intervention Participants in the intervention group used a picture booklet with a trained researcher, and a carer present. These participants kept the booklet, and were asked to use it at least twice more over 20 weeks. The control group received treatment as usual, and were provided with a booklet at the end of the study. Outcome measures 7 feasibility criteria were used relating to recruitment, data collection, attrition, potential effect on epilepsy-related quality of life (Epilepsy and Learning Disabilities Quality of Life Scale, ELDQOL) at 4-week, 12-week and 20-week follow-ups, feasibility of methodology, acceptability of the intervention and potential to calculate cost-effectiveness. Outcome The recruitment rate of eligible patients was 34% and the target of 40 participants was reached. There was minimal missing data and attrition. An intention-to-treat analysis was performed; data from the outcome measures suggest a benefit from the intervention on the ELDQOL behaviour and mood subscales at 4 and 20 weeks follow-up. The booklet and study methods were positively received, and no adverse events were reported. There was a positive indication of the potential for a cost-effectiveness analysis. Conclusions All feasibility criteria were fully or partially met, therefore confirming feasibility of a definitive trial. Trial registration number ISRCTN

  14. Can child restraint product information developed using consumer testing sustain correct use 6 months after child restraint purchase? Study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Brown, Julie; Elkington, Jane; Hall, Alexandra; Keay, Lisa; Charlton, Judith L; Hunter, Kate; Koppel, Sjaan; Hayen, Andrew; Bilston, Lynne E

    2018-03-07

    With long-standing and widespread high rates of errors in child restraint use, there is a need to identify effective methods to address this problem. Information supplied with products at the point of sale may be a potentially efficient delivery point for such a countermeasure. The aim of this study is to establish whether product materials developed using a consumer-driven approach reduce errors in restraint use among purchasers of new child restraint systems. A cluster randomised controlled trial (cRCT) will be conducted. Retail stores (n=22) in the greater Sydney area will be randomised into intervention sites (n=11) and control sites (n=11), stratified by geographical and socioeconomic indicators. Participants (n=836) will enter the study on purchase of a restraint. Outcome measures are errors in installation of the restraint as observed by a trained researcher during a 6-month follow-up home assessment, and adjustment checks made by the parent when the child is placed into the restraint (observed using naturalistic methods). Process evaluation measures will also be collected during the home visit. An intention-to-treat approach will be used for all analyses. Correct use and adjustment checks made by the parent will be compared between control and intervention groups using a logistic regression model. The number of installation errors between groups will be compared using Poisson regression. This cRCT will determine the effectiveness of targeted, consumer-driven information on actual error rates in use of restraints. More broadly, it may provide a best practice model for developing safety product information. ACTRN12617001252303p; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  15. A randomised placebo-controlled trial of early treatment of the patent ductus arteriosus.

    Science.gov (United States)

    Kluckow, Martin; Jeffery, Michele; Gill, Andy; Evans, Nick

    2014-03-01

    Failure of closure of the patent ductus arteriosus (PDA) may be associated with harm. Early cardiac ultrasound-targeted treatment of a large PDA may result in a reduction in adverse outcomes and need for later PDA closure with no increase in adverse effects. Multicentre, double-blind, placebo-controlled randomised trial. Three neonatal intensive care units in Australia. Eligible infants born <29 weeks were screened for a large PDA and received indomethacin or placebo before age 12 h. Death or abnormal cranial ultrasound. The trial ceased enrolment early due to lack of availability of indomethacin. 164 eligible infants were screened before 12 h; of the 92 infants with a large PDA, 44 were randomised to indomethacin and 48 to placebo. There was no difference in the main outcome between groups. Infants receiving early indomethacin had significantly less early pulmonary haemorrhage (PH) (2% vs 21%), a trend towards less periventricular/intraventricular haemorrhage (PIVH) (4.5% vs 12.5%) and were less likely to receive later open-label treatment for a PDA (20% vs 40%). The 72 non-randomised infants with a small PDA were at low risk of pulmonary haemorrhage and had an 80% spontaneous PDA closure rate. Early cardiac ultrasound-targeted treatment of a large PDA is feasible and safe, resulted in a reduction in early pulmonary haemorrhage and later medical treatment but had no effect on the primary outcome of death or abnormal cranial ultrasound. Australian New Zealand Clinical Trials Registry (ACTRN12608000295347).

  16. Composición química del grano de maíz (Zea mays Chococito del municipio de Quibdó, Chocó, Colombia

    Directory of Open Access Journals (Sweden)

    Melida Martínez Guardia

    2016-06-01

    Full Text Available El objetivo del presente estudio fue determinar la composición química de granos de maíz Chococito, de material vegetal obtenido en cuatro parcelas rurales del municipio de Quibdó. Los resultados obtenidos demuestran que la composición química del grano es similar a otros tipos de maíz, no obstante, difiere en el bajo contenido de almidón comparado con otras variedades. Los valores medios porcentuales de almidón, proteína cruda, grasa, fibra cruda, fibra neutro detergente, fibra ácido detergente, fósforo, potasio y azúcares totales obtenidos fueron: 68,5; 11,95 a 12,1; 3,4; 1,3; 7,6; 3,6; 1,2; 0,26 y 1,1 respectivamente y su contenido de calcio fue de 102 mg.

  17. Adjunctive rifampicin to reduce early mortality from Staphylococcus aureus bacteraemia (ARREST): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Thwaites, Guy; Auckland, Cressida; Barlow, Gavin; Cunningham, Richard; Davies, Gerry; Edgeworth, Jonathan; Greig, Julia; Hopkins, Susan; Jeyaratnam, Dakshika; Jenkins, Neil; Llewelyn, Martin; Meisner, Sarah; Nsutebu, Emmanuel; Planche, Tim; Read, Robert C; Scarborough, Matthew; Soares, Marta; Tilley, Robert; Török, M Estée; Williams, John; Wilson, Peter; Wyllie, Sarah; Walker, A Sarah

    2012-12-18

    Staphylococcus aureus bacteraemia is a common and serious infection, with an associated mortality of ~25%. Once in the blood, S. aureus can disseminate to infect almost any organ, but bones, joints and heart valves are most frequently affected. Despite the infection's severity, the evidence guiding optimal antibiotic therapy is weak: fewer than 1,500 patients have been included in 16 randomised controlled trials investigating S. aureus bacteraemia treatment. It is uncertain which antibiotics are most effective, their route of administration and duration, and whether antibiotic combinations are better than single agents. We hypothesise that adjunctive rifampicin, given in combination with a standard first-line antibiotic, will enhance killing of S. aureus early in the treatment course, sterilise infected foci and blood faster, and thereby reduce the risk of dissemination, metastatic infection and death. Our aim is to determine whether adjunctive rifampicin reduces all-cause mortality within 14 days and bacteriological failure or death within 12 weeks from randomisation. We will perform a parallel group, randomised (1:1), blinded, placebo-controlled trial in NHS hospitals across the UK. Adults (≥ 18 years) with S. aureus (meticillin-susceptible or resistant) grown from at least one blood culture who have received ≤ 96 h of active antibiotic therapy for the current infection and do not have contraindications to the use of rifampicin will be eligible for inclusion. Participants will be randomised to adjunctive rifampicin (600-900 mg/day; orally or intravenously) or placebo for the first 14 days of therapy in combination with standard single-agent antibiotic therapy. The co-primary outcome measures will be all-cause mortality up to 14 days from randomisation and bacteriological failure/death (all-cause) up to 12 weeks from randomisation. 940 patients will be recruited, providing >80% power to detect 45% and 30% reductions in the two co-primary endpoints of death by

  18. Elementary science teachers' integration of engineering design into science instruction: results from a randomised controlled trial

    Science.gov (United States)

    Maeng, Jennifer L.; Whitworth, Brooke A.; Gonczi, Amanda L.; Navy, Shannon L.; Wheeler, Lindsay B.

    2017-07-01

    This randomised controlled trial used a mixed-methods approach to investigate the frequency and how elementary teachers integrated engineering design (ED) principles into their science instruction following professional development (PD). The ED components of the PD were aligned with Cunningham and Carlsen's [(2014). Teaching engineering practices. Journal of Science Teacher Education, 25, 197-210] guidelines for ED PD and promoted inclusion of ED within science teaching. The treatment group included 219 teachers from 83 schools. Participants in the control group included 145 teachers from 60 schools in a mid-Atlantic state. Data sources, including lesson overviews and videotaped classroom observations, were analysed quantitatively to determine the frequency of ED integration and qualitatively to describe how teachers incorporated ED into instruction after attending the PD. Results indicated more participants who attended the PD (55%) incorporated ED into instruction compared with the control participants (24%), χ2(1, n = 401) = 33.225, p .05) through ED lessons. In ED lessons, students typically conducted research and created and tested initial designs. The results suggest the PD supported teachers in implementing ED into their science instruction and support the efficacy of using Cunningham and Carlsen's (2014) guidelines to inform ED PD design.

  19. Walking or vitamin B for cognition in older adults with mild cognitive impairment? A randomised controlled trial

    NARCIS (Netherlands)

    Uffelen, J.G.Z. van; Chinapaw, M.J.M.; Mechelen, W. van; Hopman-Rock, M.

    2008-01-01

    Objective: To examine the effects of aerobic exercise or vitamin B supplementation on cognitive function in older adults with mild cognitive impairment (MCI). Design: Randomised placebo-controlled trial. Setting: General community. Participants: Community-dwelling adults aged 70-80 with MCI.

  20. Relevance of randomised controlled trials in oncology.

    Science.gov (United States)

    Tannock, Ian F; Amir, Eitan; Booth, Christopher M; Niraula, Saroj; Ocana, Alberto; Seruga, Bostjan; Templeton, Arnoud J; Vera-Badillo, Francisco

    2016-12-01

    Well-designed randomised controlled trials (RCTs) can prevent bias in the comparison of treatments and provide a sound basis for changes in clinical practice. However, the design and reporting of many RCTs can render their results of little relevance to clinical practice. In this Personal View, we discuss the limitations of RCT data and suggest some ways to improve the clinical relevance of RCTs in the everyday management of patients with cancer. RCTs should ask questions of clinical rather than commercial interest, avoid non-validated surrogate endpoints in registration trials, and have entry criteria that allow inclusion of all patients who are fit to receive treatment. Furthermore, RCTs should be reported with complete accounting of frequency and management of toxicities, and with strict guidelines to ensure freedom from bias. Premature reporting of results should be avoided. The bar for clinical benefit should be raised for drug registration, which should require publication and review of mature data from RCTs, post-marketing health outcome studies, and value-based pricing. Copyright © 2016 Elsevier Ltd. All rights reserved.

  1. Identification and characterization of novel NuMA isoforms

    Energy Technology Data Exchange (ETDEWEB)

    Wu, Jin, E-mail: petersdu2112@hotmail.com [Key Laboratory for Cell Proliferation and Regulation of the Ministry of Education, Beijing Normal University, Beijing (China); Xu, Zhe [Department of Clinical Laboratory Diagnosis, Beijing Tiantan Hospital, Capital Medical University, Beijing (China); Core Laboratory for Clinical Medical Research, Beijing Tiantan Hospital, Capital Medical University, Beijing (China); He, Dacheng [Key Laboratory for Cell Proliferation and Regulation of the Ministry of Education, Beijing Normal University, Beijing (China); Lu, Guanting, E-mail: guantlv@126.com [Beijing DnaLead Science and Technology Co., LTD, Beijing (China)

    2014-11-21

    Highlights: • Seven NuMA isoforms generated by alternative splicing were categorized into 3 groups: long, middle and short. • Both exons 15 and 16 in long NuMA were “hotspot” for alternative splicing. • Lower expression of short NuMA was observed in cancer cells compared with nonneoplastic controls. • Distinct localization pattern of short isoforms indicated different function from that of long and middle NuMA. - Abstract: The large nuclear mitotic apparatus (NuMA) has been investigated for over 30 years with functions related to the formation and maintenance of mitotic spindle poles during mitosis. However, the existence and functions of NuMA isoforms generated by alternative splicing remains unclear. In the present work, we show that at least seven NuMA isoforms (categorized into long, middle and short groups) generated by alternative splicing from a common NuMA mRNA precursor were discovered in HeLa cells and these isoforms differ mainly at the carboxyl terminus and the coiled-coil domains. Two “hotspot” exons with molecular mass of 3366-nt and 42-nt tend to be spliced during alternative splicing in long and middle groups. Furthermore, full-length coding sequences of long and middle NuMA obtained by using fusion PCR were constructed into GFP-tagged vector to illustrate their cellular localization. Long NuMA mainly localized in the nucleus with absence from nucleoli during interphase and translocated to the spindle poles in mitosis. Middle NuMA displayed the similar cell cycle-dependent distribution pattern as long NuMA. However, expression of NuMA short isoforms revealed a distinct subcellular localization. Short NuMA were present in the cytosol during the whole cycle, without colocalization with mitotic apparatus. These results have allowed us tentatively to explore a new research direction for NuMA’s various functions.

  2. Translation of randomised controlled trial findings into clinical practice: comparison of olanzapine and valproate in the EMBLEM study.

    Science.gov (United States)

    Novick, D; Gonzalez-Pinto, A; Haro, J M; Bertsch, J; Reed, C; Perrin, E; Tohen, M

    2009-07-01

    The aim of this study was to compare the outcomes of olanzapine- and valproate-treated patients in an observational study of acute mania with the results of a randomised controlled trial (RCT) assessing the same treatments. EMBLEM (European Mania in Bipolar Evaluation of Medication) was a 2-year, prospective, observational study of health outcomes associated with the treatment of mania. Severity of mania and depression were assessed at baseline and 6 weeks using the YMRS and the 5-item version of the HAMD, respectively. 621 patients were analysed (n=107 valproate, n=514 olanzapine). Both groups improved from baseline to 6 weeks in mean YMRS and HAMD-5 total scores, with greater mean improvements in the olanzapine compared with the valproate group. Olanzapine was associated with more weight gain and less gastrointestinal difficulties than valproate. The EMBLEM results support those of the RCT, which suggest that olanzapine monotherapy seems to be more effective than valproate monotherapy in the treatment of acute mania.

  3. Promoting smoking cessation in Pakistani and Bangladeshi men in the UK: pilot cluster randomised controlled trial of trained community outreach workers

    Directory of Open Access Journals (Sweden)

    Barton Pelham

    2011-08-01

    Full Text Available Abstract Background Smoking prevalence is high among Pakistani and Bangladeshi men in the UK, but there are few tailored smoking cessation programmes for Pakistani and Bangladeshi communities. The aim of this study was to pilot a cluster randomised controlled trial comparing the effectiveness of Pakistani and Bangladeshi smoking cessation outreach workers with standard care to improve access to and the success of English smoking cessation services. Methods A pilot cluster randomised controlled trial was conducted in Birmingham, UK. Geographical lower layer super output areas were used to identify natural communities where more than 10% of the population were of Pakistani and Bangladeshi origin. 16 agglomerations of super output areas were randomised to normal care controls vs. outreach intervention. The number of people setting quit dates using NHS services, validated abstinence from smoking at four weeks, and stated abstinence at three and six months were assessed. The impact of the intervention on choice and adherence to treatments, attendance at clinic appointments and patient satisfaction were also assessed. Results We were able to randomise geographical areas and deliver the outreach worker-based services. More Pakistani and Bangladeshi men made quit attempts with NHS services in intervention areas compared with control areas, rate ratio (RR 1.32 (95%CI: 1.03-1.69. There was a small increase in the number of 4-week abstinent smokers in intervention areas (RR 1.30, 95%CI: 0.82-2.06. The proportion of service users attending weekly appointments was lower in intervention areas than control areas. No difference was found between intervention and control areas in choice and adherence to treatments or patient satisfaction with the service. The total cost of the intervention was £124,000; an estimated cost per quality-adjusted life year (QALY gained of £8,500. Conclusions The intervention proved feasible and acceptable. Outreach workers expanded

  4. Negative pressure wound therapy after partial diabetic foot amputation: a multicentre, randomised controlled trial.

    Science.gov (United States)

    Armstrong, David G; Lavery, Lawrence A

    2005-11-12

    Diabetic foot wounds, particularly those secondary to amputation, are very complex and difficult to treat. We investigated whether negative pressure wound therapy (NPWT) improves the proportion and rate of wound healing after partial foot amputation in patients with diabetes. We enrolled 162 patients into a 16-week, 18-centre, randomised clinical trial in the USA. Inclusion criteria consisted of partial foot amputation wounds up to the transmetatarsal level and evidence of adequate perfusion. Patients who were randomly assigned to NPWT (n=77) received treatment with dressing changes every 48 h. Control patients (n=85) received standard moist wound care according to consensus guidelines. NPWT was delivered through the Vacuum Assisted Closure (VAC) Therapy System. Wounds were treated until healing or completion of the 112-day period of active treatment. Analysis was by intention to treat. This study has been registered with , number NCT00224796. More patients healed in the NPWT group than in the control group (43 [56%] vs 33 [39%], p=0.040). The rate of wound healing, based on the time to complete closure, was faster in the NPWT group than in controls (p=0.005). The rate of granulation tissue formation, based on the time to 76-100% formation in the wound bed, was faster in the NPWT group than in controls (p=0.002). The frequency and severity of adverse events (of which the most common was wound infection) were similar in both treatment groups. NPWT delivered by the VAC Therapy System seems to be a safe and effective treatment for complex diabetic foot wounds, and could lead to a higher proportion of healed wounds, faster healing rates, and potentially fewer re-amputations than standard care.

  5. Can training improve laypersons helping behaviour in first aid? A randomised controlled deception trial.

    Science.gov (United States)

    Van de Velde, Stijn; Roex, Ann; Vangronsveld, Karoline; Niezink, Lidewij; Van Praet, Koen; Heselmans, Annemie; Donceel, Peter; Vandekerckhove, Philippe; Ramaekers, Dirk; Aertgeerts, Bert

    2013-04-01

    There is limited evidence indicating that laypersons trained in first aid provide better help, but do not help more often than untrained laypersons. This study investigated the effect of conventional first aid training versus conventional training plus supplementary training aimed at decreasing barriers to helping. The authors conducted a randomised controlled trial. After 24 h of conventional first aid training, the participants either attended an experimental lesson to reduce barriers to helping or followed a control lesson. The authors used a deception test to measure the time between the start of the unannounced simulated emergency and seeking help behaviour and the number of particular helping actions. The authors randomised 72 participants to both groups. 22 participants were included in the analysis for the experimental group and 36 in the control group. The authors found no statistically or clinically significant differences for any of the outcome measures. The time until seeking help (geometrical mean and 95% CI) was 55.5 s (42.9 to 72.0) in the experimental group and 56.5 s (43.0 to 74.3) in the control group. 57% of the participants asked a bystander to seek help, 40% left the victim to seek help themselves and 3% did not seek any help. Supplementary training on dealing with barriers to helping did not alter the helping behaviour. The timing and appropriateness of the aid provided can be improved. The authors registered this trial at ClinicalTrials.gov as NCT00954161.

  6. Evaluación de los efectos del Programa de Apoyos Directos al Campo (Procampo en el mercado de maíz en México, 2005-2007

    Directory of Open Access Journals (Sweden)

    José Alberto García-Salazar

    2011-01-01

    Full Text Available El Programa de Apoyos Directos al Campo (Procampo es un pago directo al ingreso de los productores de México que inició en 1993. El maíz es el cultivo que más recursos ha obtenido de Procampo. Los resultados de un modelo de equilibrio espacial e intertemporal indican que en ausencia de Procampo, la producción y el consumo anual de maíz hubieran sido 18.7 y 28.8 millones de toneladas en el periodo 2005-2007. Los beneficios fueron más altos que los costos del programa, y un aumento de 50% en el subsidio aumentaría la producción de maíz en 1.6 millones de toneladas y disminuiría las importaciones en 20.7%. Debido a los efectos positivos del Programa, se recomienda la continuación y el aumento del apoyo.

  7. "Sel kevadel olen ma eriti ilus..." : [luuletused] / Triin Soomets

    Index Scriptorium Estoniae

    Soomets, Triin

    2003-01-01

    Sisu: "Sel kevadel olen ma eriti ilus..." ; "Tahaksin teha midagi tõelist; midagi suurt..." ; "veebruaris on keha nii valge et syda läheb pahaks..." ; "kõige kohutavamad lepingud..." ; "Igal loojangul kutsun sind ja igal koidikul tõukan su ära..." ; "need hakid..." ; "Põhja vajudes on viimane asi, mida ma näen, rohelised sähvatused..."

  8. Effect of obstetric team training on team performance and medical technical skills: a randomised controlled trial

    NARCIS (Netherlands)

    Fransen, A. F.; van de Ven, J.; Merién, A. E. R.; de Wit-Zuurendonk, L. D.; Houterman, S.; Mol, B. W.; Oei, S. G.

    2012-01-01

    Please cite this paper as: Fransen A, van de Ven J, Merien A, de Wit-Zuurendonk L, Houterman S, Mol B, Oei S. Effect of obstetric team training on team performance and medical technical skills: a randomised controlled trial. BJOG 2012;119:13871393. Objective To determine whether obstetric team

  9. Cervical occlusion in women with cervical insufficiency: protocol for a randomised, controlled trial with cerclage, with and without cervical occlusion

    DEFF Research Database (Denmark)

    Secher, Niels Jørgen; MaCormack, CD; Weber, Tom

    2007-01-01

    OBJECTIVE: To evaluate the effect of double cerclage compared with a single cerclage. DESIGN: Randomised, controlled multicentre trial. SETTING: Ten different countries are participating with both secondary and tertiary centres. The countries participating are Denmark, Sweden, Germany, United...... Kingdom, Spain, South Africa, Australia and India. This gives both a broad spectrum of diversity global and local. We expect a total of 242 women enrolled per year. POPULATION: Prophylactic study: 1. History of cervical incompetence/insufficiency. (Delivery 15 to ..., without the membranes being exposed to the vagina. 6. Tertiary cerclage: Short cervix, membranes exposed to the vagina. Observational study: Eligible women who refuse to be randomised will participate in an observational study. 7. Repeat/requested cervical occlusion. METHODS: The women will be randomised...

  10. Safety and efficacy of antibiotics compared with appendicectomy for treatment of uncomplicated acute appendicitis: meta-analysis of randomised controlled trials

    Science.gov (United States)

    Varadhan, Krishna K; Neal, Keith R

    2012-01-01

    Objective To compare the safety and efficacy of antibiotic treatment versus appendicectomy for the primary treatment of uncomplicated acute appendicitis. Design Meta-analysis of randomised controlled trials. Population Randomised controlled trials of adult patients presenting with uncomplicated acute appendicitis, diagnosed by haematological and radiological investigations. Interventions Antibiotic treatment versus appendicectomy. Outcome measures The primary outcome measure was complications. The secondary outcome measures were efficacy of treatment, length of stay, and incidence of complicated appendicitis and readmissions. Results Four randomised controlled trials with a total of 900 patients (470 antibiotic treatment, 430 appendicectomy) met the inclusion criteria. Antibiotic treatment was associated with a 63% (277/438) success rate at one year. Meta-analysis of complications showed a relative risk reduction of 31% for antibiotic treatment compared with appendicectomy (risk ratio (Mantel-Haenszel, fixed) 0.69 (95% confidence interval 0.54 to 0.89); I2=0%; P=0.004). A secondary analysis, excluding the study with crossover of patients between the two interventions after randomisation, showed a significant relative risk reduction of 39% for antibiotic therapy (risk ratio 0.61 (0.40 to 0.92); I2=0%; P=0.02). Of the 65 (20%) patients who had appendicectomy after readmission, nine had perforated appendicitis and four had gangrenous appendicitis. No significant differences were seen for treatment efficacy, length of stay, or risk of developing complicated appendicitis. Conclusion Antibiotics are both effective and safe as primary treatment for patients with uncomplicated acute appendicitis. Initial antibiotic treatment merits consideration as a primary treatment option for early uncomplicated appendicitis. PMID:22491789

  11. Radiotherapy for Graves' orbitopathy : randomised placebo-controlled study

    NARCIS (Netherlands)

    Mourits, MP; van Kempen-Harteveld, ML; Garcia, MBG; Koppeschaar, HPF; Tick, L; Terwee, CB

    2000-01-01

    Background The best treatment (steroids, irradiation, or both) for moderately severe Graves' orbitopathy, a self-limiting disease is not known. We tested the efficacy of external beam irradiation compared with sham-irradiation. Methods In a double-blind randomised clinical trial, 30 patients with

  12. Reduction of missed appointments at an urban primary care clinic: a randomised controlled study

    Directory of Open Access Journals (Sweden)

    Calmy Alexandra

    2010-10-01

    Full Text Available Abstract Background Missed appointments are known to interfere with appropriate care and to misspend medical and administrative resources. The aim of this study was to test the effectiveness of a sequential intervention reminding patients of their upcoming appointment and to identify the profile of patients missing their appointments. Methods We conducted a randomised controlled study in an urban primary care clinic at the Geneva University Hospitals serving a majority of vulnerable patients. All patients booked in a primary care or HIV clinic at the Geneva University Hospitals were sent a reminder 48 hrs prior to their appointment according to the following sequential intervention: 1. Phone call (fixed or mobile reminder; 2. If no phone response: a Short Message Service (SMS reminder; 3. If no available mobile phone number: a postal reminder. The rate of missed appointment, the cost of the intervention, and the profile of patients missing their appointment were recorded. Results 2123 patients were included: 1052 in the intervention group, 1071 in the control group. Only 61.7% patients had a mobile phone recorded at the clinic. The sequential intervention significantly reduced the rate of missed appointments: 11.4% (n = 122 in the control group and 7.8% (n = 82 in the intervention group (p 1year (OR 2.2; CI: 1.15-4.2, substance abuse (2.09, CI 1.21-3.61, and being an asylum seeker (OR 2.73: CI 1.22-6.09. Conclusion A practical reminder system can significantly increase patient attendance at medical outpatient clinics. An intervention focused on specific patient characteristics could further increase the effectiveness of appointment reminders.

  13. Selección de progenitores de maíz para la obtención de semilla híbrida por pequeños agricultores

    Directory of Open Access Journals (Sweden)

    Roberto Valdivia

    2000-01-01

    Full Text Available El costo creciente de semilla híbrida de maíz ha limitado la productividad del cultivo en México. Por eso, los agricultores tienden a sembrar híbridos de segunda generación para reducir costos. Una mejor opción es utilizar el modelo Productor-Experimentador en la decisión de sembrar semilla de cruzas intervarietales. El objetivo del estudio fue describir la experiencia que ha tenido un grupo de productores de Santa María del Oro, Nayarit, en la producción, utilización y mejoramiento de cruzas intervarietales de maíz. En 1996, los productores sembraron seis experimentos donde observaron que la cruza B840xC343 rindió mejor que nueve híbridos comerciales. Con esta motivación, en 1997/98, los agricultores produjeron 20 toneladas de semilla de ocho cruzas. Los rendimientos de semilla fueron de 2 a 3 t/ha, así la semilla fue distribuida en la comunidad a menos del 50% del costo del híbrido comercial. En 1998, se sembraron alrededor de 400 ha con su semilla producida y se evaluaron las ocho cruzas, en cuatro experimentos. Los resultados mostraron que las mejores cruzas fueron P3028xA7573 y C385xD880. La primera cruza mostró una heterosis promedio y sobre el mejor progenitor de 4,9% y 4.1%, respectivamente; mientras que la segunda, tuvo similarmente una heterosis del 30% sobre un progenitor. A partir de 1999, los progenitores de la mejor cruza se mejorarán mediante un sistema de selección recurrente recíproca de medios hermanos, dos años por ciclo

  14. Chocolate bar as an incentive did not increase response rate among physiotherapists: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Dahm Kristin

    2008-06-01

    Full Text Available Abstract Background The aim of this study was to assess the effect of a small incentive, a bar of dark chocolate, on response rate in a study of physiotherapy performance in patients with knee osteoarthritis. Findings Norwegian physiotherapists from private practice were randomised in blocks to an intervention group (n = 1027 receiving a bar of dark chocolate together with a data-collection form, and a control group (n = 1027 that received the data-collection form only. The physiotherapists were asked to prospectively complete the data-collection form by reporting treatments provided to one patient with knee osteoarthritis through 12 treatment sessions. The outcome measure was response rate of completed forms. Out of the 510 physiotherapists that responded, 280 had completed the data-collection form by the end of the study period. There was no difference between the chocolate and no-chocolate group in response rate of those who sent in completed forms. In the chocolate group, 142 (13.8% returned completed forms compared to 138 (13.4% in the control group, ARR = 0.4 (95% CI: -3.44 to 2.6. Conclusion A bar of dark chocolate did not increase response rate in a prospective study of physiotherapy performance. Stronger incentives than chocolate seem to be necessary to increase the response rate among professionals who are asked to report about their practice. Trial Registration Current Controlled Trials register: ISRCTN02397855

  15. ChroPac-Trial: Duodenum-preserving pancreatic head resection versus pancreatoduodenectomy for chronic pancreatitis. Trial protocol of a randomised controlled multicentre trial

    Directory of Open Access Journals (Sweden)

    Schlitt Hans

    2010-04-01

    Full Text Available Abstract Background A recently published systematic review indicated superiority of duodenum-preserving techniques when compared with pancreatoduodenectomy, for the treatment of patients with chronic pancreatitis in the head of the gland. A multicentre randomised trial to confirm these results is needed. Methods/Design ChroPac aims to investigate differences in quality of life, mortality and morbidity during 24 months after surgery (duodenum-preserving pancreatic head resection versus pancreatoduodenectomy in patients with chronic pancreatitis of the pancreatic head. ChroPac is a randomised, controlled, observer and patient blinded multicentre surgical trial with two parallel comparison groups. The primary outcome measure will be the average quality of life during 24 months after surgery. Statistical analysis is based on the intention-to-treat population. Analysis of covariance will be applied for the intervention group comparison adjusting for age, centre and quality of life before surgery. Level of significance is set at 5% (two-sided and sample size (n = 100 per group is determined to assure a power of 90%. Discussion The ChroPac trial will explore important outcomes from different perspectives (e.g. surgeon, patient, health care system. Its pragmatic approach promises high external validity allowing a comprehensive evaluation of the surgical strategy for treatment of patients with chronic pancreatitis. Trial registration Controlled-trials.com ISRCTN38973832

  16. Managing Injuries of the Neck Trial (MINT): design of a randomised controlled trial of treatments for whiplash associated disorders

    Science.gov (United States)

    Lamb, Sarah E; Gates, Simon; Underwood, Martin R; Cooke, Matthew W; Ashby, Deborah; Szczepura, Ala; Williams, Mark A; Williamson, Esther M; Withers, Emma J; Mt Isa, Shahrul; Gumber, Anil

    2007-01-01

    Background A substantial proportion of patients with whiplash injuries develop chronic symptoms. However, the best treatment of acute injuries to prevent long-term problems is uncertain. A stepped care treatment pathway has been proposed, in which patients are given advice and education at their initial visit to the emergency department (ED), followed by review at three weeks and physiotherapy for those with persisting symptoms. MINT is a two-stage randomised controlled trial to evaluate two components of such a pathway: 1. use of The Whiplash Book versus usual advice when patients first attend the emergency department; 2. referral to physiotherapy versus reinforcement of advice for patients with continuing symptoms at three weeks. Methods Evaluation of the Whiplash Book versus usual advice uses a cluster randomised design in emergency departments of eight NHS Trusts. Eligible patients are identified by clinicians in participating emergency departments and are sent a study questionnaire within a week of their ED attendance. Three thousand participants will be included. Patients with persisting symptoms three weeks after their ED attendance are eligible to join an individually randomised study of physiotherapy versus reinforcement of the advice given in ED. Six hundred participants will be randomised. Follow-up is at 4, 8 and 12 months after their ED attendance. Primary outcome is the Neck Disability Index (NDI), and secondary outcomes include quality of life and time to return to work and normal activities. An economic evaluation is being carried out. Conclusion This paper describes the protocol and operational aspects of a complex intervention trial based in NHS emergency and physiotherapy departments, evaluating two components of a stepped-care approach to the treatment of whiplash injuries. The trial uses two randomisations, with the first stage being cluster randomised and the second individually randomised. PMID:17257408

  17. Randomised clinical trial

    DEFF Research Database (Denmark)

    Reimer, C; Lødrup, A; Smith, G

    2016-01-01

    of an alginate (Gaviscon Advance, Reckitt Benckiser, Slough, UK) on reflux symptoms in patients with persistent symptoms despite once daily PPI. MethodsThis was a multicentre, randomised, placebo-controlled, 7-day double-blind trial preceded by a 7-day run-in period. Reflux symptoms were assessed using...

  18. 11.72-sq cm Active-Area Wafer Interconnected PiN Diode Pulsed at 64 kA Dissipates 382 J and Exhibits an Action of 1.7 MA(sup 2)-s

    Science.gov (United States)

    2012-01-30

    calculated action exceeded 1.7 MA2 -s. Preliminary efforts on high voltage diode interconnection have produced quarter wafer interconnected PiN...was packaged in a “hockey-puck” configuration and pulsed to 64 kA, dissipating 382 J with a calculated action exceeding 1.7 MA2 -s. II. FULL...epitaxial layers are utilized. 11.72-cm2 Active-area Wafer Interconnected PiN Diode pulsed at 64 kA dissipates 382 J and exhibits an action of 1.7 MA2 -s

  19. Momento de fertilización nitrogenada de cultivos de maíz en hapludoles típicos

    Directory of Open Access Journals (Sweden)

    Mirian Barraco

    2005-12-01

    Full Text Available La producción de maíz (Zea mays L. en la región de la pampa arenosa está parcialmente limitada por la oferta de N del suelo. Si bien es frecuente la fertilización con N, la información en cuanto a los niveles críticos de respuesta y momentos de aplicación del N no es abundante. Nuestro objetivo fue determinar el momento conveniente para la fertilización con N en maíz y cuantificar la relación entre la respuesta del cultivo y algunos indicadores edáficos y de cultivo para su diagnóstico. En las campañas 2001 a 2003 se establecieron 4 sitios experimentales en Hapludoles Típicos en los que se evaluaron 7 tratamientos en un estudio factorial con 2 factores: (a Dosis de fertilización con urea (0,0, 37,5, 75,0 o 150,0 kg ha-1 de N y (b momento de aplicación (siembra o estadio de 6 hojas desplegadas. La producción de grano varió entre 5.023 y 14.757 kg ha-1. No se observaron interacciones entre dosis y momentos de fertilización con N. Tampoco se detectaron diferencias en los rendimientos entre momentos de aplicación pero sí entre las dosis aplicadas. El 90 % de los rendimientos máximos se alcanzaron con niveles de N disponible (Nsuelo siembra + Nfertilizante superiores a 142 kg ha-1 en la capa de 0 a 60 cm de profundidad. La intensidad de coloración verde de las hojas en estadios vegetativos contribuyó a distinguir entre tratamientos con y sin aplicación de N pero fue insuficiente para su utilización como herramienta de diagnóstico de necesidades de fertilización. En Hapludoles Típicos de la región de la pampa arenosa la corrección de necesidades de N para maximizar los rendimientos de maíz requiere de un correcto diagnóstico a partir del análisis de suelo y la aplicación de N indistintamente en el momento de la siembra o en estadios de desarrollo vegetativo.In the sandy Pampas region, corn (Zea mays L. grain production is partially related with soil N availability levels. Although N fertilization is common practice

  20. EXTUBATE: A randomised controlled trial of nasal biphasic positive airway pressure vs. nasal continuous positive airway pressure following extubation in infants less than 30 weeks' gestation: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Victor Suresh

    2011-12-01

    Full Text Available Abstract Background Respiratory distress syndrome remains a significant problem among premature infants. Mechanical ventilation through an endotracheal tube remains the mainstay of respiratory support but may be associated with lung injury and the development of chronic lung disease of prematurity. Efforts are needed to reduce the duration of mechanical ventilation in favour of less invasive forms of respiratory support and to improve rates of successful extubation. Non-invasive respiratory support has been demonstrated to be less injurious to the premature lung. Standard practice is to use nasal continuous positive airway pressure (n-CPAP following extubation to support the baby's breathing. Many clinicians also use nasal biphasic positive airway pressure (n-BiPAP in efforts to improve rates of successful extubation. However, there is currently no evidence that this confers any advantage over conventional nasal continuous positive airway pressure. Methods We propose an unblinded multi-centre randomised trial comparing n-CPAP with n-BiPAP in babies born before 30 weeks' gestation and less than two weeks old. Babies with congenital abnormalities and severe intra-ventricular haemorrhage will be excluded. 540 babies admitted to neonatal centres in England will be randomised at the time of first extubation attempt. The primary aim of this study is to compare the rate of extubation failure within 48 hours following the first attempt at extubation. The secondary aims are to compare the effect of n-BiPAP and n-CPAP on the following outcomes: 1. Maintenance of successful extubation for 7 days post extubation 2. Oxygen requirement at 28 days of age and at 36 weeks' corrected gestational age 3. Total days on ventilator, n-CPAP/n-BiPAP 4. Number of ventilator days following first extubation attempt 5. pH and partial pressure of carbon dioxide in the first post extubation blood gas 6. Duration of hospital stay 7. Rate of abdominal distension requiring

  1. Antidepressants for depressive disorder in children and adolescents: a database of randomised controlled trials.

    Science.gov (United States)

    Zhang, Yuqing; Zhou, Xinyu; Pu, Juncai; Zhang, Hanping; Yang, Lining; Liu, Lanxiang; Zhou, Chanjuan; Yuan, Shuai; Jiang, Xiaofeng; Xie, Peng

    2018-05-31

    In recent years, whether, when and how to use antidepressants to treat depressive disorder in children and adolescents has been hotly debated. Relevant evidence on this topic has increased rapidly. In this paper, we present the construction and content of a database of randomised controlled trials of antidepressants to treat depressive disorder in children and adolescents. This database can be freely accessed via our website and will be regularly updated. Major bibliographic databases (PubMed, the Cochrane Library, Web of Science, Embase, CINAHL, PsycINFO and LiLACS), international trial registers and regulatory agencies' websites were systematically searched for published and unpublished studies up to April 30, 2017. We included randomised controlled trials in which the efficacy or tolerability of any oral antidepressant was compared with that of a control group or any other treatment. In total, 7377 citations from bibliographical databases and 3289 from international trial registers and regulatory agencies' websites were identified. Of these, 53 trials were eligible for inclusion in the final database. Selected data were extracted from each study, including characteristics of the participants (the study population, setting, diagnostic criteria, type of depression, age, sex, and comorbidity), characteristics of the treatment conditions (the treatment conditions, general information, and detail of pharmacotherapy and psychotherapy) and study characteristics (the sponsor, country, number of sites, blinding method, sample size, treatment duration, depression scales, other scales, and primary outcome measure used, and side-effect monitoring method). Moreover, the risk of bias for each trial were assessed. This database provides information on nearly all randomised controlled trials of antidepressants in children and adolescents. By using this database, researchers can improve research efficiency, avoid inadvertent errors and easily focus on the targeted subgroups in

  2. Podiatry intervention versus usual care to prevent falls in care homes: pilot randomised controlled trial (the PIRFECT study).

    Science.gov (United States)

    Wylie, Gavin; Menz, Hylton B; McFarlane, Sarah; Ogston, Simon; Sullivan, Frank; Williams, Brian; Young, Zoe; Morris, Jacqui

    2017-07-12

    Common foot problems are independent risk factors for falls in older people. There is evidence that podiatry can prevent falls in community-dwelling populations. The feasibility of implementing a podiatry intervention and trial in the care home population is unknown. To inform a potential future definitive trial, we performed a pilot randomised controlled trial to assess: (i) the feasibility of a trial of a podiatry intervention to reduce care home falls, and (ii) the potential direction and magnitude of the effect of the intervention in terms of number of falls in care home residents. Informed by Medical Research Council guidance on developing and evaluating complex interventions, we conducted a single blind, pilot randomised controlled trial in six care homes in the East of Scotland. Participants were randomised to either: (i) a three month podiatry intervention comprising core podiatry care, foot and ankle exercises, orthoses and footwear provision or (ii) usual care. Falls-related outcomes (number of falls, time to first fall) and feasibility-related outcomes (recruitment, retention, adherence, data collection rates) were collected. Secondary outcomes included: generic health status, balance, mobility, falls efficacy, and ankle joint strength. 474 care home residents were screened. 43 (9.1%) participants were recruited: 23 to the intervention, 20 to control. Nine (21%) participants were lost to follow-up due to declining health or death. It was feasible to deliver the trial elements in the care home setting. 35% of participants completed the exercise programme. 48% reported using the orthoses 'all or most of the time'. Completion rates of the outcome measures were between 93% and 100%. No adverse events were reported. At the nine month follow-up period, the intervention group per-person fall rate was 0.77 falls vs. 0.83 falls in the control group. A podiatry intervention to reduce falls can be delivered to care home residents within a pilot randomised

  3. Randomised controlled trial of online continuing education for health professionals to improve the management of chronic fatigue syndrome: a study protocol.

    Science.gov (United States)

    Li, Sophie H; Sandler, Carolina X; Casson, Sally M; Cassar, Joanne; Bogg, Tina; Lloyd, Andrew R; Barry, Benjamin K

    2017-05-10

    Chronic fatigue syndrome (CFS) is a serious and debilitating illness that affects between 0.2%-2.6% of the world's population. Although there is level 1 evidence of the benefit of cognitive behaviour therapy (CBT) and graded exercise therapy (GET) for some people with CFS, uptake of these interventions is low or at best untimely. This can be partly attributed to poor clinician awareness and knowledge of CFS and related CBT and GET interventions. This trial aims to evaluate the effect of participation in an online education programme, compared with a wait-list control group, on allied health professionals' knowledge about evidence-based CFS interventions and their levels of confidence to engage in the dissemination of these interventions. A randomised controlled trial consisting of 180 consenting allied health professionals will be conducted. Participants will be randomised into an intervention group (n=90) that will receive access to the online education programme, or a wait-list control group (n=90). The primary outcomes will be: 1) knowledge and clinical reasoning skills regarding CFS and its management, measured at baseline, postintervention and follow-up, and 2) self-reported confidence in knowledge and clinical reasoning skills related to CFS. Secondary outcomes include retention of knowledge and satisfaction with the online education programme. The influence of the education programme on clinical practice behaviour, and self-reported success in the management of people with CFS, will also be assessed in a cohort study design with participants from the intervention and control groups combined. The study protocol has been approved by the Human Research Ethics Committee at The University of New South Wales (approval number HC16419). Results will be disseminated via peer-reviewed journal articles and presentations at scientific conferences and meetings. ACTRN12616000296437. © Article author(s) (or their employer(s) unless otherwise stated in the text of the

  4. Adición de vitaminas y minerales a harinas de maíz y de trigo en México

    OpenAIRE

    Rosado Jorge L.; Camacho-Solís Rafael; Bourges Héctor

    1999-01-01

    En México la deficiencia marginal de algunas vitaminas y minerales afecta la salud y la funcionalidad de un número elevado de mexicanos, por lo que la Secretaría de Salud ha iniciado un programa para promover la adición de nutrimentos a las harinas de trigo y de maíz que se procesan industrialmente. El presente documento expone las bases científicas y tecnológicas para dicha adición. El objetivo primordial es restaurar los nutrimentos que se pierden durante el proceso de obtención de las hari...

  5. Increase in physical activities in kindergarten children with cerebral palsy by employing MaKey-MaKey-based task systems.

    Science.gov (United States)

    Lin, Chien-Yu; Chang, Yu-Ming

    2014-09-01

    In this study, we employed Flash- and Scratch-based multimedia by using a MaKey-MaKey-based task system to increase the motivation level of children with cerebral palsy to perform physical activities. MaKey MaKey is a circuit board that converts physical touch to a digital signal, which is interpreted by a computer as a keyboard message. In this study, we used conductive materials to control this interaction. This study followed single-case design using ABAB models in which A indicated the baseline and B indicated the intervention. The experiment period comprised 1 month and a half. The experimental results demonstrated that in the case of two kindergarten children with cerebral palsy, their scores were considerably increased during the intervention phrases. The developmental applications of the results are also discussed. Copyright © 2014 Elsevier Ltd. All rights reserved.

  6. Effect of Systematic Follow-Up by General Practitioners after Deliberate Self-Poisoning: A Randomised Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Tine K Grimholt

    Full Text Available To assess whether systematic follow-up by general practitioners (GPs of cases of deliberate self-poisoning (DSP by their patients decreases psychiatric symptoms and suicidal behaviour compared with current practice.Randomised clinical trial with two parallel groups.General practices in Oslo and the eastern part of Akershus County.Patients aged 18-75 years admitted to hospital for DSP. We excluded patients diagnosed with psychoses, without a known GP, those not able to complete a questionnaire, and patients admitted to psychiatric in-patient care or other institutions where their GP could not follow them immediately after discharge.The GPs received a written guideline, contacted the patients and scheduled a consultation within one week after discharge, and then provided regular consultations for six months. We randomised the patients to either intervention (n = 78 or treatment as usual (n = 98.Primary outcome measure was the Beck Scale for Suicide Ideation (SSI. Secondary outcomes were Beck Depression Inventory (BDI and Beck Hopelessness Scale (BHS, self-reported further self-harm and treatment for DSP in a general hospital or an emergency medical agency (EMA. We assessed patients on entry to the trial and at three and six months. We collected data from interviews, self-report questionnaires, and hospital and EMA medical records.There were no significant differences between the groups in SSI, BDI, or BHS mean scores or change from baseline to three or six months. During follow-up, self-reported DSP was 39.5% in the intervention group vs. 15.8% in controls (P = 0.009. Readmissions to general hospitals were similar (13% in both groups (P = 0.963, while DSP episodes treated at EMAs were 17% in the intervention group and 7% in the control group (P = 0.103.Structured follow-up by GPs after an episode of DSP had no significant effect on suicide ideation, depression or hopelessness. There was no significant difference in repeated episodes of DSP in

  7. Group treatments for sensitive health care problems : a randomised controlled trial of group versus individual physiotherapy sessions for female urinary incontinence

    OpenAIRE

    Lamb, S. E. (Sallie E.); Pepper, Jo; Lall, Ranjit; Jørstad-Stein , Ellen C.; Clark, M. D. (Michael D.); Hill, Lesley; Fereday Smith, Jan

    2009-01-01

    Abstract Background The aim was to compare effectiveness of group versus individual sessions of physiotherapy in terms of symptoms, quality of life, and costs, and to investigate the effect of patient preference on uptake and outcome of treatment. Methods A pragmatic, multi-centre randomised controlled trial in five British National Health Service physiotherapy departments. 174 women with stress and/or urge incontinence were randomised to receive treatment from a physiotherapist delivered in ...

  8. Ma tean, mida sa näitad end olevat teinud läinud suvel / Laura Kuusk

    Index Scriptorium Estoniae

    Kuusk, Laura, 1982-

    2006-01-01

    Kuraator Marco Laimre juhendamisel valminud Eesti Kunstiakadeemia III kursuse fotograafiaüliõpilaste suvepraktika tööde näitus "Ma tean, mida sa tegid läinud suvel / I know what you did last summer" Eesti Kunstiakadeemia galeriis kuni 3. X. Helina Kõrmi, Dmitri Gerassimovi, Kristjan-Jaak Tammiksaare, Anne-Mai Pällo, Tuuli Antsovi, Terje Ugandi, Ivar Veermäe, Riika Tauriaineni, Kätly Kaibaldi, Raul Viitungi ja Andrus Kaursoni töödest

  9. No effect of an oleoylethanolamide-related phospholipid on satiety and energy intake: a randomised controlled trial of phosphatidylethanolamine

    Directory of Open Access Journals (Sweden)

    Strik CM

    2008-10-01

    Full Text Available Abstract Background Phosphatidylethanolamine (PE is a phospholipid which is biosynthesized into long chain N-acylethanolamines (NAEs including oleoylethanolamide (OEA, a known inhibitor of food intake. The aim of this study was to investigate whether PE-containing lipids can also inhibit intake. This was a 4 treatment intervention where 18 male participants were given a high-fat test breakfast (2.5MJ, 53 en% fat containing (i high-phospholipid, high-PE lipid (ii high-phospholipid, medium-PE lipid (iii no-phospholipid, no-PE control lipid or (iv water control, in a randomised cross-over. Visual analogue scales (VAS were used to assess post-ingestive hunger and satiety, and energy intake (EI was measured at an ad libitum lunch meal after 3.5hours. Results When compared with the water control, the 3 lipid treatments resulted in lower levels of hunger and thoughts of food, greater fullness and satisfaction (all, treatment*time interaction, P Conclusion Despite the close relationship of PE with OEA, there was no evidence from this acute study that dietary phospholipids containing PE can favourably modify eating behaviour.

  10. Effect of peer support on prevention of postnatal depression among high risk women: multisite randomised controlled trial.

    Science.gov (United States)

    Dennis, C-L; Hodnett, E; Kenton, L; Weston, J; Zupancic, J; Stewart, D E; Kiss, A

    2009-01-15

    To evaluate the effectiveness of telephone based peer support in the prevention of postnatal depression. Multisite randomised controlled trial. Seven health regions across Ontario, Canada. 701 women in the first two weeks postpartum identified as high risk for postnatal depression with the Edinburgh postnatal depression scale and randomised with an internet based randomisation service. Proactive individualised telephone based peer (mother to mother) support, initiated within 48-72 hours of randomisation, provided by a volunteer recruited from the community who had previously experienced and recovered from self reported postnatal depression and attended a four hour training session. Edinburgh postnatal depression scale, structured clinical interview-depression, state-trait anxiety inventory, UCLA loneliness scale, and use of health services. After web based screening of 21 470 women, 701 (72%) eligible mothers were recruited. A blinded research nurse followed up more than 85% by telephone, including 613 at 12 weeks and 600 at 24 weeks postpartum. At 12 weeks, 14% (40/297) of women in the intervention group and 25% (78/315) in the control group had an Edinburgh postnatal depression scale score >12 (chi(2)=12.5, P<0.001; number need to treat 8.8, 95% confidence interval 5.9 to 19.6; relative risk reduction 0.46, 95% confidence interval 0.24 to 0.62). There was a positive trend in favour of the intervention group for maternal anxiety but not loneliness or use of health services. For ethical reasons, participants identified with clinical depression at 12 weeks were referred for treatment, resulting in no differences between groups at 24 weeks. Of the 221 women in the intervention group who received and evaluated their experience of peer support, over 80% were satisfied and would recommend this support to a friend. Telephone based peer support can be effective in preventing postnatal depression among women at high risk. ISRCTN 68337727.

  11. Laser in Glaucoma and Ocular Hypertension (LiGHT) trial. A multicentre, randomised controlled trial: design and methodology.

    Science.gov (United States)

    Gazzard, Gus; Konstantakopoulou, Evgenia; Garway-Heath, David; Barton, Keith; Wormald, Richard; Morris, Stephen; Hunter, Rachael; Rubin, Gary; Buszewicz, Marta; Ambler, Gareth; Bunce, Catey

    2018-05-01

    The Laser in Glaucoma and Ocular Hypertension (LiGHT) Trial aims to establish whether initial treatment with selective laser trabeculoplasty (SLT) is superior to initial treatment with topical medication for primary open-angle glaucoma (POAG) or ocular hypertension (OHT). The LiGHT Trial is a prospective, unmasked, multicentre, pragmatic, randomised controlled trial. 718 previously untreated patients with POAG or OHT were recruited at six collaborating centres in the UK between 2012 and 2014. The trial comprises two treatment arms: initial SLT followed by conventional medical therapy as required, and medical therapy without laser therapy. Randomisation was provided online by a web-based randomisation service. Participants will be monitored for 3 years, according to routine clinical practice. The target intraocular pressure (IOP) was set at baseline according to an algorithm, based on disease severity and lifetime risk of loss of vision at recruitment, and subsequently adjusted on the basis of IOP control, optic disc and visual field. The primary outcome measure is health-related quality of life (HRQL) (EQ-5D five-level). Secondary outcomes are treatment pathway cost and cost-effectiveness, Glaucoma Utility Index, Glaucoma Symptom Scale, Glaucoma Quality of Life, objective measures of pathway effectiveness, visual function and safety profiles and concordance. A single main analysis will be performed at the end of the trial on an intention-to-treat basis. The LiGHT Trial is a multicentre, pragmatic, randomised clinical trial that will provide valuable data on the relative HRQL, clinical effectiveness and cost-effectiveness of SLT and topical IOP-lowering medication. ISRCTN32038223, Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  12. Randomised clinical trial

    DEFF Research Database (Denmark)

    Coyle, C; Crawford, G; Wilkinson, J

    2017-01-01

    BACKGROUND: Symptomatic breakthrough in proton pump inhibitor (PPI)-treated gastro-oesophageal reflux disease (GERD) patients is a common problem with a range of underlying causes. The nonsystemic, raft-forming action of alginates may help resolve symptoms. AIM: To assess alginate-antacid (Gaviscon...... Double Action, RB, Slough, UK) as add-on therapy to once-daily PPI for suppression of breakthrough reflux symptoms. METHODS: In two randomised, double-blind studies (exploratory, n=52; confirmatory, n=262), patients taking standard-dose PPI who had breakthrough symptoms, assessed by Heartburn Reflux...

  13. Can exercise improve self esteem in children and young people? A systematic review of randomised controlled trials

    OpenAIRE

    Ekeland, E; Heian, F; Hagen, K; Coren, E

    2005-01-01

    Twenty three randomised controlled trials were analysed. A synthesis of several small, low quality trials indicates that exercise may have short term beneficial effects on self esteem in children and adolescents. However, high quality research on defined populations with adequate follow up is needed.

  14. Elementary Science Teachers' Integration of Engineering Design into Science Instruction: Results from a Randomised Controlled Trial

    Science.gov (United States)

    Maeng, Jennifer L.; Whitworth, Brooke A.; Gonczi, Amanda L.; Navy, Shannon L.; Wheeler, Lindsay B.

    2017-01-01

    This randomised controlled trial used a mixed-methods approach to investigate the frequency and how elementary teachers integrated engineering design (ED) principles into their science instruction following professional development (PD). The ED components of the PD were aligned with Cunningham and Carlsen's [(2014). "Teaching engineering…

  15. Kangaroo mother method: randomised controlled trial of an alternative method of care for stabilised low-birthweight infants. Maternidad Isidro Ayora Study Team.

    Science.gov (United States)

    Sloan, N L; Camacho, L W; Rojas, E P; Stern, C

    1994-09-17

    Because resources for care of low-birthweight (LBW) infants in developing countries are scarce, the Kangaroo mother method (KMM) was developed. The infant is kept upright in skin-to-skin contact with the mother's breast. Previous studies reported several benefits with the KMM but interpretation of their findings is limited by small size and design weaknesses. We have done a longitudinal, randomised, controlled trial at the Isidro Ayora Maternity Hospital in Quito, Ecuador. Infants with LBW (groups (n = 128 and 147, respectively). During 6 months of follow-up the KMM group had a significantly lower rate than the control group of serious illness (lower-respiratory-tract disorders, apnoea, aspiration, pneumonia, septicaemia, general infections; 7 [5%] vs 27 [18%], p groups in less severe morbidity were not significant. There was no significant difference in growth or in the proportion of women breastfeeding, perhaps because the proportion breastfeeding was high in both groups owing to strong promotion. Mortality was the same in both groups; most deaths occurred during the stabilisation period before randomisation. KMM mothers made more unscheduled clinic visits than control mothers but their infants had fewer re-admissions and so the cost of care was lower with the KMM. Since the eligibility criteria excluded nearly 50% of LBW infants from the study, the KMM is not universally applicable to these infants. The benefits might be greater in populations where breastfeeding is not so common.

  16. Developing an Australian-first recovery model for parents in Victorian mental health and family services: a study protocol for a randomised controlled trial.

    Science.gov (United States)

    Maybery, Darryl; Goodyear, Melinda; Reupert, Andrea; Sheen, Jade; Cann, Warren; Dalziel, Kim; Tchernagovski, Phillip; O'Hanlon, Brendan; von Doussa, Henry

    2017-05-26

    A considerable number of people with a mental illness are parents caring for dependent children. For those with a mental illness, parenting can provide a sense of competence, belonging, identity and hope and hence is well aligned to the concept of personal recovery. However, little research has focused on the recovery journey of those who are parents and have a mental illness. This randomised controlled trial aims to (i) evaluate the effectiveness of an intervention model of recovery for parents (Let's Talk about Children) in three different mental health service sectors and (ii) examine the economic value of a larger roll out (longer term) of the parent recovery model. A two arm parallel randomised controlled trial will be used with participants, who are being treated for their mental illness in adult mental health, non-government community mental health or family welfare services. The study will involve 192 parents, who are considered by their treating practitioner to be sufficiently well to provide informed consent and participate in an intervention (Let's Talk about Children) or control group (treatment as usual). Participant randomisation will occur at the level of the treating practitioner and will be based on whether the randomised practitioner is trained in the intervention. Outcomes are compared at pre, post intervention and six-month follow-up. Recovery, parenting and family functioning, and quality of life questionnaires will be used to measure parent wellbeing and the economic benefits of the intervention. This is the first randomised controlled trial to investigate the efficacy of a parenting intervention on recovery outcomes and the first to provide an economic evaluation of an intervention for parents with a mental illness. An implementation model is required to embed the intervention in different sectors. The trial was retrospectively registered: ACTRN12616000460404 on the 8/4/2016.

  17. Evaluación del gluten de maíz como una fuente reemplazante de la harina de pescado en dietas para el camarón juvenil litopenaeus vannamei

    OpenAIRE

    Molina, César

    2004-01-01

    Evaluación del gluten de maíz como una fuente reemplazante de la harina de pescado en dietas para el camarón juvenil Litopenaeus vannamei En alimentos para especies acuáticas comerciales, la harina de pescado es una de las fuentes de proteína marina más ampliamente usada, por su alto valor nutricional y palatabilidad.

  18. Detailed systematic analysis of recruitment strategies in randomised controlled trials in patients with an unscheduled admission to hospital

    Science.gov (United States)

    Rooshenas, Leila; Fairhurst, Katherine; Rees, Jonathan; Gamble, Carrol; Blazeby, Jane M

    2018-01-01

    Objectives To examine the design and findings of recruitment studies in randomised controlled trials (RCTs) involving patients with an unscheduled hospital admission (UHA), to consider how to optimise recruitment in future RCTs of this nature. Design Studies within the ORRCA database (Online Resource for Recruitment Research in Clinical TriAls; www.orrca.org.uk) that reported on recruitment to RCTs involving UHAs in patients >18 years were included. Extracted data included trial clinical details, and the rationale and main findings of the recruitment study. Results Of 3114 articles populating ORRCA, 39 recruitment studies were eligible, focusing on 68 real and 13 hypothetical host RCTs. Four studies were prospectively planned investigations of recruitment interventions, one of which was a nested RCT. Most recruitment papers were reports of recruitment experiences from one or more ‘real’ RCTs (n=24) or studies using hypothetical RCTs (n=11). Rationales for conducting recruitment studies included limited time for informed consent (IC) and patients being too unwell to provide IC. Methods to optimise recruitment included providing patients with trial information in the prehospital setting, technology to allow recruiters to cover multiple sites, screening logs to uncover recruitment barriers, and verbal rather than written information and consent. Conclusion There is a paucity of high-quality research into recruitment in RCTs involving UHAs with only one nested randomised study evaluating a recruitment intervention. Among the remaining studies, methods to optimise recruitment focused on how to improve information provision in the prehospital setting and use of screening logs. Future research in this setting should focus on the prospective evaluation of the well-developed interventions to optimise recruitment. PMID:29420230

  19. Reducing the default dispense quantity for new opioid analgesic prescriptions: study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Bachhuber, Marcus A; Nash, Denis; Southern, William N; Heo, Moonseong; Berger, Matthew; Schepis, Mark; Cunningham, Chinazo O

    2018-04-20

    As opioid analgesic consumption has grown, so have opioid use disorder and opioid-related overdoses. Reducing the quantity of opioid analgesics prescribed for acute non-cancer pain can potentially reduce risks to the individual receiving the prescription and to others who might unintentionally or intentionally consume any leftover tablets. Reducing the default dispense quantity for new opioid analgesic prescriptions in the electronic health record (EHR) is a promising intervention to reduce prescribing. This study is a prospective cluster randomised controlled trial with two parallel arms. Primary care sites (n=32) and emergency departments (n=4) will be randomised in matched pairs to either a modification of the EHR so that new opioid analgesic prescriptions default to a dispense quantity of 10 tablets (intervention) or to no EHR change (control). The dispense quantity will remain fully modifiable by providers in both arms. From 6 months preintervention to 18 months postintervention, patient-level data will be analysed (ie, the patient is the unit of inference). Patient eligibility criteria are: (A) received a new opioid analgesic prescription, defined as no other opioid analgesic prescription in the prior 6 months; (B) age ≥18 years; and (C) no cancer diagnosis within 1 year prior to the new opioid analgesic prescription. The primary outcome will be the quantity of opioid analgesics prescribed in the initial prescription. Secondary outcomes will include opioid analgesic reorders and health service utilisation within 30 days after the initial prescription. Outcomes will be compared between study arms using a difference-in-differences analysis. This study has been approved by the Montefiore Medical Center/Albert Einstein College of Medicine Institutional Review Board with a waiver of informed consent (2016-6036) and is registered on ClinicalTrials.gov (NCT03003832, 6 December 2016). Findings will be disseminated through publication, conferences and meetings

  20. Obtención y caracterización de harinas compuestas de endospermo - germen de maíz y su uso en la preparación de arepas

    Directory of Open Access Journals (Sweden)

    HERNÁNDEZ Blanca D.

    1999-01-01

    Full Text Available La arepa, pan de maíz, es un producto elaborado a partir de harina precocida de endospermo de maíz, de elevado consumo en Colombia y Venezuela. Al obtener la harina de endospermo queda como subproducto el germen del que se extrae aceite que deja como residuo el germen desgrasado (GD. En el presente trabajo se formularon harinas compuestas del endospermo - GD. Se hicieron mezclas sustituyendo la harina precocida en 6, 8, 10 y 12%. Se evaluaron las propiedades físico - químicas, funcionales, sensoriales y nutricionales. Se encontró que al agregar el germen no aumenta significativamente la cantidad de proteína pero si mejora en más de un 300% la calidad nutricional de la misma, en la cual la relación de eficiencia proteica pasa de 0,16 hasta 1,04 en las harinas compuestas. La digestibilidad en las mezclas (> 89,5%, fue superior al valor obtenido para la harina precocida (84,02%. El contenido en fibra y grasa no varió significativamente en la harina compuesta, así mismo el color, peso específico, pH, separación de agua, adhesividad, absorción y solubilidad en agua no mostraron variaciones significativas. Sustituciones mayores a 6% mostraron pequeñas desviaciones respecto al rango establecido (3-5 cm para la expansión, sin afectar el amasado. Se prepararon arepas evaluándose su aceptabilidad. Se encontró que las arepas con 6% de GD fueron de mayor preferencia al compararlas con arepas de harina precocida, por lo que se concluyó que este porcentaje de sustitución sería el más viable, para enriquecer la harina precocida.

  1. A randomised control trial of low glycaemic index carbohydrate diet versus no dietary intervention in the prevention of recurrence of fetal macrosomia.

    LENUS (Irish Health Repository)

    Walsh, Jennifer

    2010-04-23

    Abstract Background Maternal weight and maternal weight gain during pregnancy exert a significant influence on infant birth weight and the incidence of macrosomia. Fetal macrosomia is associated with an increase in both adverse obstetric and neonatal outcome, and also confers a future risk of childhood obesity. Studies have shown that a low glycaemic diet is associated with lower birth weights, however these studies have been small and not randomised 1 2 . Fetal macrosomia recurs in a second pregnancy in one third of women, and maternal weight influences this recurrence risk 3 . Methods\\/Design We propose a randomised control trial of low glycaemic index carbohydrate diet vs. no dietary intervention in the prevention of recurrence of fetal macrosomia. Secundigravid women whose first baby was macrosomic, defined as a birth weight greater than 4000 g will be recruited at their first antenatal visit. Patients will be randomised into two arms, a control arm which will receive no dietary intervention and a diet arm which will be commenced on a low glycaemic index diet. The primary outcome measure will be the mean birth weight centiles and ponderal indices in each group. Discussion Altering the source of maternal dietary carbohydrate may prove to be valuable in the management of pregnancies where there has been a history of fetal macrosomia. Fetal macrosomia recurs in a second pregnancy in one third of women. This randomised control trial will investigate whether or not a low glycaemic index diet can affect this recurrence risk. Current Controlled Trials Registration Number ISRCTN54392969

  2. A pilot randomised controlled trial of negative pressure wound therapy to treat grade III/IV pressure ulcers [ISRCTN69032034

    Science.gov (United States)

    2012-01-01

    Background Negative pressure wound therapy (NPWT) is widely promoted as a treatment for full thickness wounds; however, there is a lack of high-quality research evidence regarding its clinical and cost effectiveness. A trial of NPWT for the treatment of grade III/IV pressure ulcers would be worthwhile but premature without assessing whether such a trial is feasible. The aim of this pilot randomised controlled trial was to assess the feasibility of conducting a future full trial of NPWT for the treatment of grade III and IV pressure ulcers and to pilot all aspects of the trial. Methods This was a two-centre (acute and community), pilot randomised controlled trial. Eligible participants were randomised to receive either NPWT or standard care (SC) (spun hydrocolloid, alginate or foam dressings). Outcome measures were time to healing of the reference pressure ulcer, recruitment rates, frequency of treatment visits, resources used and duration of follow-up. Results Three hundred and twelve patients were screened for eligibility into this trial over a 12-month recruitment period and 12/312 participants (3.8%) were randomised: 6 to NPWT and 6 to SC. Only one reference pressure ulcer healed (NPWT group) during follow-up (time to healing 79 days). The mean number of treatment visits per week was 3.1 (NPWT) and 5.7 (SC); 6/6 NPWT and 1/6 SC participants withdrew from their allocated trial treatment. The mean duration of follow-up was 3.8 (NPWT) and 5.0 (SC) months. Conclusions This pilot trial yielded vital information for the planning of a future full study including projected recruitment rate, required duration of follow-up and extent of research nurse support required. Data were also used to inform the cost-effectiveness and value of information analyses, which were conducted alongside the pilot trial. Trial registration Current Controlled Trials ISRCTN69032034. PMID:22839453

  3. A pilot randomised controlled trial of negative pressure wound therapy to treat grade III/IV pressure ulcers [ISRCTN69032034

    Directory of Open Access Journals (Sweden)

    Ashby Rebecca L

    2012-07-01

    Full Text Available Abstract Background Negative pressure wound therapy (NPWT is widely promoted as a treatment for full thickness wounds; however, there is a lack of high-quality research evidence regarding its clinical and cost effectiveness. A trial of NPWT for the treatment of grade III/IV pressure ulcers would be worthwhile but premature without assessing whether such a trial is feasible. The aim of this pilot randomised controlled trial was to assess the feasibility of conducting a future full trial of NPWT for the treatment of grade III and IV pressure ulcers and to pilot all aspects of the trial. Methods This was a two-centre (acute and community, pilot randomised controlled trial. Eligible participants were randomised to receive either NPWT or standard care (SC (spun hydrocolloid, alginate or foam dressings. Outcome measures were time to healing of the reference pressure ulcer, recruitment rates, frequency of treatment visits, resources used and duration of follow-up. Results Three hundred and twelve patients were screened for eligibility into this trial over a 12-month recruitment period and 12/312 participants (3.8% were randomised: 6 to NPWT and 6 to SC. Only one reference pressure ulcer healed (NPWT group during follow-up (time to healing 79 days. The mean number of treatment visits per week was 3.1 (NPWT and 5.7 (SC; 6/6 NPWT and 1/6 SC participants withdrew from their allocated trial treatment. The mean duration of follow-up was 3.8 (NPWT and 5.0 (SC months. Conclusions This pilot trial yielded vital information for the planning of a future full study including projected recruitment rate, required duration of follow-up and extent of research nurse support required. Data were also used to inform the cost-effectiveness and value of information analyses, which were conducted alongside the pilot trial. Trial registration Current Controlled Trials ISRCTN69032034.

  4. Efficacy of labral repair, biceps tenodesis, and diagnostic arthroscopy for SLAP Lesions of the shoulder: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Mowinckel Petter

    2010-10-01

    Full Text Available Abstract Background Surgery for type II SLAP (superior labral anterior posterior lesions of the shoulder is a promising but unproven treatment. The procedures include labral repair or biceps tenodesis. Retrospective cohort studies have suggested that the benefits of tenodesis include pain relief and improved function, and higher patient satisfaction, which was reported in a prospective non-randomised study. There have been no completed randomised controlled trials of surgery for type II SLAP lesions. The aims of this participant and observer blinded randomised placebo-controlled trial are to compare the short-term (6 months and long-term (2 years efficacy of labral repair, biceps tenodesis, and placebo (diagnostic arthroscopy for alleviating pain and improving function for type II SLAP lesions. Methods/Design A double-blind randomised controlled trial are performed using 120 patients, aged 18 to 60 years, with a history for type II SLAP lesions and clinical signs suggesting type II SLAP lesion, which were documented by MR arthrography and arthroscopy. Exclusion criteria include patients who have previously undergone operations for SLAP lesions or recurrent shoulder dislocations, and ruptures of the rotator cuff or biceps tendon. Outcomes will be assessed at baseline, three, six, 12, and 24 months. Primary outcome measures will be the clinical Rowe Score (1988-version and the Western Ontario Instability Index (WOSI at six and 24 months. Secondary outcome measures will include the Shoulder Instability Questionnaire (SIQ, the generic EuroQol (EQ-5 D and EQ-VAS, return to work and previous sports activity, complications, and the number of reoperations. Discussion The results of this trial will be of international importance and the results will be translatable into clinical practice. Trial Registration [ClinicalTrials.gov NCT00586742

  5. Information and Choice of A-Level Subjects: A Cluster Randomised Controlled Trial with Linked Administrative Data

    Science.gov (United States)

    Davies, Peter; Davies, Neil M.; Qiu, Tian

    2017-01-01

    We estimated the effects of an intervention which provided information about graduate wages to 5593 students in England, using a blinded cluster randomised controlled trial in 50 schools (registration: AEARCTR-0000468). Our primary outcome was students' choice of A-level subjects at age 16. We also recorded the students' expectations of future…

  6. Synthesis of 9,9,9-trideutero-1,4-dihydroxynonane mercapturic acid (d3-DHN-MA), a useful internal standard for DHN-MA urinalysis.

    Science.gov (United States)

    Chantegrel, B; Deshayes, C; Doutheau, A; Steghens, J P

    2002-10-01

    Racemic 1,4-dihydroxynonane mercapturic acid (DHN-MA) and 9,9,9-trideutero-1,4-dihydroxynonane mercapturic acid (d3-DHN-MA) are synthesized on a 400-mg scale (overall yield approximately 40%) by a two-step sequence involving Michael addition of N-acetyl-L-cysteine to methyl 4-hydroxynon-2(E)-enoate or methyl 9,9,9-trideutero-4-hydroxynon-2 (E)-enoate, followed by reduction of the intermediate adducts with lithium borohydride. The requisite starting methyl esters are obtained, respectively, from heptanal or 7,7,7-trideuteroheptanal and methyl 4-chlorophenylsulfinylacetate via a sulfoxide piperidine and carbonyl reaction described in the literature. The 7,7,7-trideuteroheptanal is easily prepared by classical methods in four steps from 6-bromo-1-hexanol. 13C NMR data indicate that DHN-MA as well as d3-DHN-MA are obtained as mixtures of four diastereomers. Preliminary results show that d3-DHN-MA could be used as an internal standard for mass spectrometric quantification of DHN-MA in human urine.

  7. The RESPITE trial: remifentanil intravenously administered patient-controlled analgesia (PCA) versus pethidine intramuscular injection for pain relief in labour: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Wilson, Matthew; MacArthur, Christine; Gao Smith, Fang; Homer, Leanne; Handley, Kelly; Daniels, Jane

    2016-12-12

    The commonest opioid used for pain relief in labour is pethidine (meperidine); however, its effectiveness has long been challenged and the drug has known side effects including maternal sedation, nausea and potential transfer across the placenta to the foetus. Over a third of women receiving pethidine require an epidural due to inadequate pain relief. Epidural analgesia increases the risk of an instrumental vaginal delivery and its associated effects. Therefore, there is a clear need for a safe, effective, alternative analgesic to pethidine. Evidence suggests that remifentanil patient-controlled analgesia (PCA) reduces epidural conversion rates compared to pethidine; however, no trial has yet investigated this as a primary endpoint. We are, therefore, comparing pethidine intramuscular injection to remifentanil PCA in a randomised controlled trial. Women in established labour, requesting systemic opioid pain relief, will be randomised to either intravenously administered remifentanil PCA (intervention) or pethidine intramuscular injection (control) in an unblinded, 1:1 individual randomised trial. Following informed consent, 400 women in established labour, who request systemic opioid pain relief, from NHS Trusts across England will undergo a minimised randomisation by a computer or automated telephone system to either pethidine or remifentanil. In order to balance the groups this minimisation is based on four parameters; parity (nulliparous versus multiparous), maternal age (Asian (Pakistani/Indian/Bangladeshi) versus Other) and induced versus spontaneous labour. The effectiveness of pain relief provided by each technique will be recorded every 30 min after time zero, until epidural placement, delivery or transfer to theatre, quantified by Visual Analogue Scale. Incidence of maternal side effects including sedation, delivery mode, foetal distress requiring delivery, neonatal status at delivery and rate of initiation of breastfeeding within the first hour of birth

  8. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial.

    Science.gov (United States)

    Bolinder, Jan; Antuna, Ramiro; Geelhoed-Duijvestijn, Petronella; Kröger, Jens; Weitgasser, Raimund

    2016-11-05

    Tight control of blood glucose in type 1 diabetes delays onset of macrovascular and microvascular diabetic complications; however, glucose levels need to be closely monitored to prevent hypoglycaemia. We aimed to assess whether a factory-calibrated, sensor-based, flash glucose-monitoring system compared with self-monitored glucose testing reduced exposure to hypoglycaemia in patients with type 1 diabetes. In this multicentre, prospective, non-masked, randomised controlled trial, we enrolled adult patients with well controlled type 1 diabetes (HbA 1c ≤58 mmol/mol [7·5%]) from 23 European diabetes centres. After 2 weeks of all participants wearing the blinded sensor, those with readings for at least 50% of the period were randomly assigned (1:1) to flash sensor-based glucose monitoring (intervention group) or to self-monitoring of blood glucose with capillary strips (control group). Randomisation was done centrally using the biased-coin minimisation method dependent on study centre and type of insulin administration. Participants, investigators, and study staff were not masked to group allocation. The primary outcome was change in time in hypoglycaemia (diabetes spent in hypoglycaemia. Future studies are needed to assess the effectiveness of this technology in patients with less well controlled diabetes and in younger age groups. Abbott Diabetes Care. Copyright © 2016 Elsevier Ltd. All rights reserved.

  9. Infant feeding bottle design, growth and behaviour: results from a randomised trial

    Directory of Open Access Journals (Sweden)

    Fewtrell MS

    2012-03-01

    Full Text Available Abstract Background Whether the design of an anti-vacuum infant feeding bottle influences infant milk intake, growth or behavior is unknown, and was the subject of this randomized trial. Methods Subjects 63 (36 male healthy, exclusively formula-fed term infants. Intervention Randomisation to use Bottle A (n = 31, one-way air valve: Philips Avent versus Bottle B (n = 32, internal venting system: Dr Browns. 74 breast-fed reference infants were recruited, with randomisation (n = 24 to bottle A (n = 11 or B (n = 13 if bottle-feeding was subsequently introduced. Randomisation stratified by gender and parity; computer-based telephone randomisation by independent clinical trials unit. Setting Infant home. Primary outcome measure infant weight gain to 4 weeks. Secondary outcomes (i milk intake (ii infant behaviour measured at 2 weeks (validated 3-day diary; (iii risk of infection; (iv continuation of breastfeeding following introduction of mixed feeding. Results Number analysed for primary outcome Bottle A n = 29, Bottle B n = 25. Primary outcome There was no significant difference in weight gain between randomised groups (0-4 weeks Bottle A 0.74 (SD 1.2 SDS versus bottle B 0.51 (0.39, mean difference 0.23 (95% CI -0.31 to 0.77. Secondary outcomes Infants using bottle A had significantly less reported fussing (mean 46 versus 74 minutes/day, p Breast-fed reference group There were no significant differences in primary or secondary outcomes between breast-fed and formula fed infants. The likelyhood of breastfeeding at 3 months was not significantly different in infants subsequently randomised to bottle A or B. Conclusion Bottle design may have short-term effects on infant behaviour which merit further investigation. No significant effects were seen on milk intake or growth; confidence in these findings is limited by the small sample size and this needs confirmation in a larger study. Trial registration Clinical Trials.gov NCT00325208.

  10. Evaluating the effectiveness of a smartphone app to reduce excessive alcohol consumption: protocol for a factorial randomised control trial

    Directory of Open Access Journals (Sweden)

    Claire Garnett

    2016-07-01

    Full Text Available Abstract Background Excessive alcohol consumption is a leading cause of death and morbidity worldwide and interventions to help people reduce their consumption are needed. Interventions delivered by smartphone apps have the potential to help harmful and hazardous drinkers reduce their consumption of alcohol. However, there has been little evaluation of the effectiveness of existing smartphone interventions. A systematic review, amongst other methodologies, identified promising modular content that could be delivered by an app: self-monitoring and feedback; action planning; normative feedback; cognitive bias re-training; and identity change. This protocol reports a factorial randomised controlled trial to assess the comparative potential of these five intervention modules to reduce excessive alcohol consumption. Methods A between-subject factorial randomised controlled trial. Hazardous and harmful drinkers aged 18 or over who are making a serious attempt to reduce their drinking will be randomised to one of 32 (25 experimental conditions after downloading the ‘Drink Less’ app. Participants complete baseline measures on downloading the app and are contacted after 1-month with a follow-up questionnaire. The primary outcome measure is change in past week consumption of alcohol. Secondary outcome measures are change in AUDIT score, app usage data and usability ratings for the app. A factorial between-subjects ANOVA will be conducted to assess main and interactive effects of the five intervention modules for the primary and secondary outcome measures. Discussion This study will establish the extent to which the five intervention modules offered in this app can help reduce hazardous and harmful drinking. This is the first step in optimising and understanding what component parts of an app could help to reduce excessive alcohol consumption. The findings from this study will be used to inform the content of a future integrated treatment app and

  11. Evaluating the effectiveness of a smartphone app to reduce excessive alcohol consumption: protocol for a factorial randomised control trial.

    Science.gov (United States)

    Garnett, Claire; Crane, David; Michie, Susan; West, Robert; Brown, Jamie

    2016-07-08

    Excessive alcohol consumption is a leading cause of death and morbidity worldwide and interventions to help people reduce their consumption are needed. Interventions delivered by smartphone apps have the potential to help harmful and hazardous drinkers reduce their consumption of alcohol. However, there has been little evaluation of the effectiveness of existing smartphone interventions. A systematic review, amongst other methodologies, identified promising modular content that could be delivered by an app: self-monitoring and feedback; action planning; normative feedback; cognitive bias re-training; and identity change. This protocol reports a factorial randomised controlled trial to assess the comparative potential of these five intervention modules to reduce excessive alcohol consumption. A between-subject factorial randomised controlled trial. Hazardous and harmful drinkers aged 18 or over who are making a serious attempt to reduce their drinking will be randomised to one of 32 (2(5)) experimental conditions after downloading the 'Drink Less' app. Participants complete baseline measures on downloading the app and are contacted after 1-month with a follow-up questionnaire. The primary outcome measure is change in past week consumption of alcohol. Secondary outcome measures are change in AUDIT score, app usage data and usability ratings for the app. A factorial between-subjects ANOVA will be conducted to assess main and interactive effects of the five intervention modules for the primary and secondary outcome measures. This study will establish the extent to which the five intervention modules offered in this app can help reduce hazardous and harmful drinking. This is the first step in optimising and understanding what component parts of an app could help to reduce excessive alcohol consumption. The findings from this study will be used to inform the content of a future integrated treatment app and evaluated against a minimal control in a definitive randomised

  12. Preventing academic difficulties in preterm children: a randomised controlled trial of an adaptive working memory training intervention - IMPRINT study.

    Science.gov (United States)

    Pascoe, Leona; Roberts, Gehan; Doyle, Lex W; Lee, Katherine J; Thompson, Deanne K; Seal, Marc L; Josev, Elisha K; Nosarti, Chiara; Gathercole, Susan; Anderson, Peter J

    2013-09-16

    Very preterm children exhibit difficulties in working memory, a key cognitive ability vital to learning information and the development of academic skills. Previous research suggests that an adaptive working memory training intervention (Cogmed) may improve working memory and other cognitive and behavioural domains, although further randomised controlled trials employing long-term outcomes are needed, and with populations at risk for working memory deficits, such as children born preterm.In a cohort of extremely preterm (memory and attention 2 weeks', 12 months' and 24 months' post-intervention, and to investigate training related neuroplasticity in working memory neural networks 2 weeks' post-intervention. This double-blind, placebo-controlled, randomised controlled trial aims to recruit 126 extremely preterm/extremely low birthweight 7-year-old children. Children attending mainstream school without major intellectual, sensory or physical impairments will be eligible. Participating children will undergo an extensive baseline cognitive assessment before being randomised to either an adaptive or placebo (non-adaptive) version of Cogmed. Cogmed is a computerised working memory training program consisting of 25 sessions completed over a 5 to 7 week period. Each training session takes approximately 35 minutes and will be completed in the child's home. Structural, diffusion and functional Magnetic Resonance Imaging, which is optional for participants, will be completed prior to and 2 weeks following the training period. Follow-up assessments focusing on academic skills (primary outcome), working memory and attention (secondary outcomes) will be conducted at 2 weeks', 12 months' and 24 months' post-intervention. To our knowledge, this study will be the first randomised controlled trial to (a) assess the effectiveness of Cogmed in school-aged extremely preterm/extremely low birthweight children, while incorporating advanced imaging techniques to investigate neural changes

  13. The Women's international study of long-duration oestrogen after menopause (WISDOM: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Meade Tom W

    2007-02-01

    Full Text Available Abstract Background At the time of feasibility work and final design of the trial there was no randomised control trial evidence for the long-term risks and benefits of hormone replacement therapy. Observational studies had suggested that long term use of estrogen was likely to be associated, amongst other things, with reduced risks of osteoporosis and ischaemic heart disease and increased risks of breast and endometrial cancer. Concomitant use of progestogens had been shown to protect against endometrial cancer, but there were few data showing how progestogen might affect estrogen actions on other conditions. Disease specific risks from observational studies suggested that, overall, long-term HRT was likely to be beneficial. Several studies showed that mortality from all causes was lower in HRT users than in non-users. Some secondary cardiovascular prevention trials were ongoing but evidence was also required for a range of outcomes in healthy women. The WISDOM trial was designed to compare combined estrogen and progestogen versus placebo, and estrogen alone versus combined estrogen and progestogen. During the development of WISDOM the Women's Health Initiative trial was designed, funded and started in the US. Design Randomised, placebo, controlled, trial. Methods The trial was set in general practices in the UK (384, Australia (94, and New Zealand (24. In these practices 284175 women aged 50–69 years were registered with 226282 potentially eligible. We sought to randomise 22300 postmenopausal women aged 50 – 69 and treat for ten years. The interventions were: conjugated equine estrogens, 0.625 mg orally daily; conjugated equine estrogens plus medroxyprogesterone acetate 2.5/5.0 mg orally daily; matched placebo. Primary outcome measures were: major cardiovascular disease, osteoporotic fractures, breast cancer and dementia. Secondary outcomes were: other cancers, all cause death, venous thromboembolism and cerebro-vascular disease. Results

  14. Does n-3 LCPUFA supplementation during pregnancy increase the IQ of children at school age? Follow-up of a randomised controlled trial.

    Science.gov (United States)

    Gould, Jacqueline F; Treyvaud, Karli; Yelland, Lisa N; Anderson, Peter J; Smithers, Lisa G; Gibson, Robert A; McPhee, Andrew J; Makrides, Maria

    2016-05-17

    Despite recommendations that pregnant women increase their docosahexaenoic acid (DHA) intake to support fetal brain development, a recent systematic review found a lack of high-quality data to support the long-term effects of DHA supplementation on children's neurodevelopment. We will assess child neurodevelopment at 7 years of age in follow-up of a multicentre double-blind randomised controlled trial of DHA supplementation in pregnancy. In 2010-2012, n=2399 Australian women with a singleton pregnancy Intelligence, Second Edition. Specific measures of executive functioning (Fruit Stroop and the Rey Complex Figure), attention (Test of Everyday Attention for Children), memory and learning (Rey Auditory Verbal Learning Test), language (Clinical Evaluation of Language Fundamentals, Fourth Edition) and basic educational skills (Wide Range Achievement Test, Fourth Edition) will also be administered. Caregivers will be asked to complete questionnaires measuring behaviour and executive functioning. Families, clinicians and research personnel are blinded to group assignment with the exception of families who requested unblinding prior to the follow-up. All analyses will be conducted according to the intention-to-treat principal. All procedures will be approved by the relevant institutional ethics committees prior to start of the study. The results of this study will be disseminated in peer-reviewed journal publications and academic presentations. ACTRN12605000569606 and ACTRN12614000770662. 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/

  15. Physiotherapy Rehabilitation for Osteoporotic Vertebral Fracture (PROVE): study protocol for a randomised controlled trial

    Science.gov (United States)

    2014-01-01

    Background Osteoporosis and vertebral fracture can have a considerable impact on an individual’s quality of life. There is increasing evidence that physiotherapy including manual techniques and exercise interventions may have an important treatment role. This pragmatic randomised controlled trial will investigate the clinical and cost-effectiveness of two different physiotherapy approaches for people with osteoporosis and vertebral fracture, in comparison to usual care. Methods/Design Six hundred people with osteoporosis and a clinically diagnosed vertebral fracture will be recruited and randomly allocated to one of three management strategies, usual care (control - A), an exercise-based physiotherapy intervention (B) or a manual therapy-based physiotherapy intervention (C). Those in the usual care arm will receive a single session of education and advice, those in the active treatment arms (B + C) will be offered seven individual physiotherapy sessions over 12 weeks. The trial is designed as a prospective, adaptive single-blinded randomised controlled trial. An interim analysis will be completed and if one intervention is clearly superior the trial will be adapted at this point to continue with just one intervention and the control. The primary outcomes are quality of life measured by the disease specific QUALLEFO 41 and the Timed Loaded Standing test measured at 1 year. Discussion There are a variety of different physiotherapy packages used to treat patients with osteoporotic vertebral fracture. At present, the indication for each different therapy is not well defined, and the effectiveness of different modalities is unknown. Trial registration Reference number ISRCTN49117867. PMID:24422876

  16. A double-blind randomised cross-over comparison of nabilone and metoclopramide in the control of radiation-induced nausea

    International Nuclear Information System (INIS)

    Priestman, S.G.; Priestman, T.J.; Canney, P.A.

    1987-01-01

    Forty patients who were suffering from radiation induced emesis were entered into a prospectively randomised double-blind cross-over study comparing nabilone with metoclopramide. Only patients who had at least five treatments remaining of their planned course of irradiation were randomised, in order to allow an adequate time to monitor the degree of symptom control and any adverse effects of the two drugs. Patient characteristics and the incidence and severity of nausea and vomiting were similar for the two groups. There was no difference in the efficacy of the two drugs but the incidence and severity of adverse reactions was significantly greater in those patients who received nabilone. (author)

  17. Predictors of employment for people with severe mental illness : results of an international six-centre randomised controlled trial

    NARCIS (Netherlands)

    Catty, Jocelyn; Lissouba, Pascale; White, Sarah; Becker, Thomas; Drake, Robert E.; Fioritti, Angelo; Knapp, Martin; Lauber, Christoph; Roessler, Wulf; Tomov, Toma; Van Busschbach, Jooske; Wiersma, Durk; Burns, Tom; Rossler, W.

    Background An international six-centre randomised controlled trial comparing individual placement and support (IPS) with usual vocational rehabilitation for people with serious mental illness found IPS to be more effective for all vocational outcomes. Aims To determine which patients with severe

  18. The effectiveness of a clinically integrated e-learning course in evidence-based medicine: A cluster randomised controlled trial

    NARCIS (Netherlands)

    Kulier, Regina; Coppus, Sjors F. P. J.; Zamora, Javier; Hadley, Julie; Malick, Sadia; Das, Kausik; Weinbrenner, Susanne; Meyerrose, Berrit; Decsi, Tamas; Horvath, Andrea R.; Nagy, Eva; Emparanza, Jose I.; Arvanitis, Theodoros N.; Burls, Amanda; Cabello, Juan B.; Kaczor, Marcin; Zanrei, Gianni; Pierer, Karen; Stawiarz, Katarzyna; Kunz, Regina; Mol, Ben W. J.; Khan, Khalid S.

    2009-01-01

    ABSTRACT: BACKGROUND: To evaluate the educational effects of a clinically integrated e-learning course for teaching basic evidence-based medicine (EBM) among postgraduates compared to a traditional lecture-based course of equivalent content. METHODS: We conducted a cluster randomised controlled

  19. Protocolo para la producción de plantas dihaploides de trigo duro mediante cruzamientos con maíz

    OpenAIRE

    García Llamas, Carmen

    2011-01-01

    El objetivo de este trabajo ha sido desarrollar un protocolo para producir plantas dihaploides de trigo duro, mediante cruzamientos con maíz, que permita acortar la duración de los programas de mejora de esta especie. Entre las variantes de este método se ha elegido el cultivo de tallos cortados, porque permite controlar las condiciones ambientales durante el desarrollo de los embriones y abaratar los costes de aplicación de las hormonas. Se han abordado y mejorado tres aspectos de esta técni...

  20. Empoderamiento y feminismo comunitario en la conservación del maíz en México

    OpenAIRE

    Ana Gabriela Rincón Rubio; Ivonne Vizcarra Bordi; Humberto Thomé Ortíz; Patricia Gascón Muro

    2017-01-01

    El objetivo es analizar, desde una perspectiva basada en el feminismo comunitario, el proceso de empoderamiento de las mujeres que conforman un grupo de ocho integrantes matlatzincas de la comunidad de San Francisco Oxtotilpan, México, a través de prácticas productivas, alimentarias y culturales en torno al maíz nativo. Los datos fueron recogidos durante 2014 y 2015 con técnicas etnográficas que incluyen: observación participante, historias de vida, grupos focales, entrevistas semiestructurad...

  1. Uso de remesas para la adquisición de tecnología agrícola en maíz en San José Chiapa, Puebla, México

    Directory of Open Access Journals (Sweden)

    Teresa Turiján Altamirano

    2015-01-01

    Full Text Available El destino de las remesas varía de acuerdo a las necesidades de los hogares receptores, aunque generalmente se emplean en gastos de manutención, y en menores porcentajes se utilizan para otros rubros como el ahorro, gastos de educación, mejoras, ampliación o construcción de vivienda e inversiones como compra de tierras, inicio o capitalización de un negocio y adquisición de maquinaria agrícola. Esta investigación tuvo como objetivo determinar la contribución de las remesas en la adquisición de tecnología agrícola por productores de maíz de San José Chiapa, Puebla. Por ello se aplicó, en 2009, a una muestra representativa de 110 productores de maíz, una encuesta que abarcó aspectos sociodemográficos, económicos y agronómicos. Con la información recabada se estimó por una parte el nivel de adopción de tecnologías entre los productores utilizando el Índice de Apropiación de Tecnologías Modernas (IATM y el Grado de Empleo de Tecnologías Campesinas (GETC. Por otra parte, se clasificó a los productores en dos grupos: sin remesas y con remesas. La información se analizó utilizando estadística descriptiva, pruebas de t para comparcion de medias independientes y una regresión logística para seleccionar las variables que explicaran el uso de las remesas. Se observaron diferencias significativas en variables socioeconómicas donde el tamaño de la familia, la edad y el gasto mensual per cápita, el grupo con remesas obtuvo los valores más altos respecto al grupo sin remesas. En cuanto al manejo del maíz, se observó una mayor utilización de tecnologás modernas en distintas actividades agrícolas entre los productores con remesas, a diferencia del grupo sin remesas. Por lo que se entiende que el Índice Apropiación de Tecnologías Modernas haya resultado más alto en el grupo con remesas (59.5 unidades. Así mismo, este grupo obtuvo un rendimiento más alto con 2.92 t/ha. Tal situación refleja que las remesas juegan

  2. Molienda húmeda de Maíz : Optimización del proceso y desarrollo de nuevas técnicas tendientes a mejorar la calidad de sus productos

    OpenAIRE

    Haros, Claudia Mónica

    1999-01-01

    El propósito de esta tesis fue investigar algunas aspectos básicas de la molienda húmeda convencional de maíz y evaluar la capacidad de molienda de tres híbridos regionales de este grana: dentada, semidentado y colorada dura. Otras objetivas fixeran evaluar la incidencia de las condiciones past-cosecha en el rendimiento y calidad de la fiacción amilácea, determinar la cinética de difusión y de reacción química del anhídrido sulfuraso en el grano de maíz y proponer modificaciones en la moliend...

  3. Results of a multicentre randomised controlled trial of statistical process control charts and structured diagnostic tools to reduce ward-acquired meticillin-resistant Staphylococcus aureus: the CHART Project.

    Science.gov (United States)

    Curran, E; Harper, P; Loveday, H; Gilmour, H; Jones, S; Benneyan, J; Hood, J; Pratt, R

    2008-10-01

    Statistical process control (SPC) charts have previously been advocated for infection control quality improvement. To determine their effectiveness, a multicentre randomised controlled trial was undertaken to explore whether monthly SPC feedback from infection control nurses (ICNs) to healthcare workers of ward-acquired meticillin-resistant Staphylococcus aureus (WA-MRSA) colonisation or infection rates would produce any reductions in incidence. Seventy-five wards in 24 hospitals in the UK were randomised into three arms: (1) wards receiving SPC chart feedback; (2) wards receiving SPC chart feedback in conjunction with structured diagnostic tools; and (3) control wards receiving neither type of feedback. Twenty-five months of pre-intervention WA-MRSA data were compared with 24 months of post-intervention data. Statistically significant and sustained decreases in WA-MRSA rates were identified in all three arms (Pcontrol wards, but with no significant difference between the control and intervention arms (P=0.23). There were significantly more post-intervention 'out-of-control' episodes (P=0.021) in the control arm (averages of 0.60, 0.28, and 0.28 for Control, SPC and SPC+Tools wards, respectively). Participants identified SPC charts as an effective communication tool and valuable for disseminating WA-MRSA data.

  4. Motivational interviewing as a smoking cessation strategy with nurses: an exploratory randomised controlled trial.

    Science.gov (United States)

    Mujika, Agurtzane; Forbes, Angus; Canga, Navidad; de Irala, Jokin; Serrano, Inmaculada; Gascó, Plácido; Edwards, Margaret

    2014-08-01

    Despite the important role that health professionals have in reducing tobacco use, many have a smoking habit themselves. The prevalence of smoking is particularly high among nurses. To test the efficacy, acceptability and feasibility of a motivational interviewing (MI) based smoking cessation intervention with nurses. Two group parallel experimental design with random allocation to groups. A large teaching hospital in the North of Spain. Nurses who smoked (n=30) were randomised into two groups: motivational interviewing based intervention (n=15) and usual care (n=15). Motivational interviewing based intervention consisted of four individual MI sessions. Usual care consisted of brief advice. Variables considered to assess efficacy were biochemically verified smoking cessation, mean cigarettes smoked, stages of change, self-efficacy and depression score. Variables to assess acceptability and feasibility included participant satisfaction, adherence to MI, and duration of sessions. Data were collected at: baseline, end of intervention and three months after the end of the intervention. At three month follow up, compared with the control group, more nurses in the intervention group had quit (absolute difference 33.3%; 95% confidence interval [CI] 2.6-58.2). In the nurses who did not quit, there was no significant difference between the intervention and control groups in the number of cigarettes smoked per day, although progress in the stages of change was greater in the intervention group compared to the control group. Measures of acceptability and feasibility indicated good satisfaction with the intervention, with high levels of attendance and completion. This study found a beneficial effect of motivational interviewing on nurses' smoking cessation. The intervention was acceptable for nurses and a number of aspects were identified that need to be considered prior to conducting a larger scale in order to optimise the intervention. Using MI might be a novel approach to

  5. Facilitating return to work through early specialist health-based interventions (FRESH): protocol for a feasibility randomised controlled trial.

    Science.gov (United States)

    Radford, Kathryn A; Phillips, Julie; Jones, Trevor; Gibson, Ali; Sutton, Chris; Watkins, Caroline; Sach, Tracey; Duley, Lelia; Walker, Marion; Drummond, Avril; Hoffman, Karen; O'Connor, Rory; Forshaw, Denise; Shakespeare, David

    2015-01-01

    Over one million people sustain traumatic brain injury each year in the UK and more than 10 % of these are moderate or severe injuries, resulting in cognitive and psychological problems that affect the ability to work. Returning to work is a primary rehabilitation goal but fewer than half of traumatic brain injury survivors achieve this. Work is a recognised health service outcome, yet UK service provision varies widely and there is little robust evidence to inform rehabilitation practice. A single-centre cohort comparison suggested better work outcomes may be achieved through early occupational therapy targeted at job retention. This study aims to determine whether this intervention can be delivered in three new trauma centres and to conduct a feasibility, randomised controlled trial to determine whether its effects and cost effectiveness can be measured to inform a definitive trial. Mixed methods study, including feasibility randomised controlled trial, embedded qualitative studies and feasibility economic evaluation will recruit 102 people with traumatic brain injury and their nominated carers from three English UK National Health Service (NHS) trauma centres. Participants will be randomised to receive either usual NHS rehabilitation or usual rehabilitation plus early specialist traumatic brain injury vocational rehabilitation delivered by an occupational therapist. The primary objective is to assess the feasibility of conducting a definitive trial; secondary objectives include measurement of protocol integrity (inclusion/exclusion criteria, intervention adherence, reasons for non-adherence) recruitment rate, the proportion of eligible patients recruited, reasons for non-recruitment, spectrum of TBI severity, proportion of and reasons for loss to follow-up, completeness of data collection, gains in face-to-face V s postal data collection and the most appropriate methods of measuring primary outcomes (return to work, retention) to determine the sample size for a

  6. What's wrong with John? a randomised controlled trial of Mental Health First Aid (MHFA) training with nursing students.

    Science.gov (United States)

    Burns, Sharyn; Crawford, Gemma; Hallett, Jonathan; Hunt, Kristen; Chih, Hui Jun; Tilley, P J Matt

    2017-03-23

    The prevalence of mental health problems have been found to be higher among university students compared to their non-student peers. Nursing students in particular face a range of additional stressors which may impact their undergraduate performance and their careers. Mental Health First Aid (MHFA) aims to increase mental health literacy and to reduce stigma and may positively impact on the student population. This paper describes a MHFA randomised controlled trial targeting nursing students at a large Australian university. This study aimed to measure the impact of the MHFA course on mental health literacy, mental health first aid intentions, confidence in helping someone with a mental health problem and stigmatising attitudes including social distance. Participants were first year nursing students (n = 181) randomly allocated to the intervention (n = 92) or control (n = 89) group. Intervention group participants received the standardised MHFA course for nursing students. Online self-report questionnaires were completed at three time intervals: baseline (one week prior to the intervention: T 1 ) (n = 140), post intervention (T 2 ) (n = 120), and two months post intervention (T 3 ) (n = 109). Measures included demographics, mental health knowledge, recognition of depression, confidence in helping, mental health first aid intentions and stigmatising attitudes including social distance. Repeated measures ANOVA was computed to measure if the impact of time (T 1 , T 2 , T 3 ) and group (intervention and control) on the outcome variables. There was a significant improvement among intervention compared to control group participants across the three time periods for knowledge scores (p mental health first aid intentions (p mental health literacy and reduce stigmatising attitudes and social distance. While this cours