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Sample records for parallel group randomised

  1. Mandibular advancement appliance for obstructive sleep apnoea: results of a randomised placebo controlled trial using parallel group design

    DEFF Research Database (Denmark)

    Petri, N.; Svanholt, P.; Solow, B.

    2008-01-01

    The aim of this trial was to evaluate the efficacy of a mandibular advancement appliance (MAA) for obstructive sleep apnoea (OSA). Ninety-three patients with OSA and a mean apnoea-hypopnoea index (AHI) of 34.7 were centrally randomised into three, parallel groups: (a) MAA; (b) mandibular non......). Eighty-one patients (87%) completed the trial. The MAA group achieved mean AHI and Epworth scores significantly lower (P group and the no-intervention group. No significant differences were found between the MNA group and the no-intervention group. The MAA group had...

  2. CONSORT 2010 Explanation and Elaboration: Updated guidelines for reporting parallel group randomised trials

    DEFF Research Database (Denmark)

    Moher, David; Hopewell, Sally; Schulz, Kenneth F

    2010-01-01

    Overwhelming evidence shows the quality of reporting of randomised controlled trials (RCTs) is not optimal. Without transparent reporting, readers cannot judge the reliability and validity of trial findings nor extract information for systematic reviews. Recent methodological analyses indicate...... that inadequate reporting and design are associated with biased estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which are considered the gold standard for evaluating interventions because of their ability to minimise or avoid bias. A group of scientists and editors developed......, this revised explanatory and elaboration document, and the associated website (www.consort-statement.org) should be helpful resources to improve reporting of randomised trials....

  3. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials (Chinese version)

    DEFF Research Database (Denmark)

    Moher, David; Hopewell, Sally; Schulz, Kenneth F

    2010-01-01

    Overwhelming evidence shows the quality of reporting of randomised controlled trials (RCTs) is not optimal. Without transparent reporting, readers cannot judge the reliability and validity of trial findings nor extract information for systematic reviews. Recent methodological analyses indicate...... that inadequate reporting and design are associated with biased estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which are considered the gold standard for evaluating interventions because of their ability to minimise or avoid bias. A group of scientists and editors developed......, this revised explanatory and elaboration document, and the associated website (www.consort-statement.org) should be helpful resources to improve reporting of randomised trials....

  4. A double blind, randomised, parallel group study on the efficacy and safety of treating acute lateral ankle sprain with oral hydrolytic enzymes

    NARCIS (Netherlands)

    Kerkhoffs, G. M. M. J.; Struijs, P. A. A.; de Wit, C.; Rahlfs, V. W.; Zwipp, H.; van Dijk, C. N.

    2004-01-01

    Objective: To compare the effectiveness and safety of the triple combination Phlogenzym ( rutoside, bromelain, and trypsin) with double combinations, the single substances, and placebo. Design: Multinational, multicentre, double blind, randomised, parallel group design with eight groups structured

  5. Intervention for children with word-finding difficulties: a parallel group randomised control trial.

    Science.gov (United States)

    Best, Wendy; Hughes, Lucy Mari; Masterson, Jackie; Thomas, Michael; Fedor, Anna; Roncoli, Silvia; Fern-Pollak, Liory; Shepherd, Donna-Lynn; Howard, David; Shobbrook, Kate; Kapikian, Anna

    2017-07-31

    The study investigated the outcome of a word-web intervention for children diagnosed with word-finding difficulties (WFDs). Twenty children age 6-8 years with WFDs confirmed by a discrepancy between comprehension and production on the Test of Word Finding-2, were randomly assigned to intervention (n = 11) and waiting control (n = 9) groups. The intervention group had six sessions of intervention which used word-webs and targeted children's meta-cognitive awareness and word-retrieval. On the treated experimental set (n = 25 items) the intervention group gained on average four times as many items as the waiting control group (d = 2.30). There were also gains on personally chosen items for the intervention group. There was little change on untreated items for either group. The study is the first randomised control trial to demonstrate an effect of word-finding therapy with children with language difficulties in mainstream school. The improvement in word-finding for treated items was obtained following a clinically realistic intervention in terms of approach, intensity and duration.

  6. 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.

  7. The efficacy of Femal in women with premenstrual syndrome: a randomised, double-blind, parallel-group, placebo-controlled, multicentre study

    DEFF Research Database (Denmark)

    Gerhardsen, G.; Hansen, A.V.; Killi, M.

    2008-01-01

    Introduction: A double-blind, placebo-controlled, randomised, parallel-group, multicentre study was conducted to evaluate the effect of a pollen-based herbal medicinal product, Femal (R) (Sea-Band Ltd, Leicestershire, UK), on premenstrual sleep disturbances (PSD) in women with premenstrual syndrome...... as the main symptom cluster makes this herbal medicinal product a promising addition to the therapeutic arsenal for women with PMS Udgivelsesdato: 2008/6...

  8. Immediate interruption of sedation compared with usual sedation care in critically ill postoperative patients (SOS-Ventilation): a randomised, parallel-group clinical trial.

    Science.gov (United States)

    Chanques, Gerald; Conseil, Matthieu; Roger, Claire; Constantin, Jean-Michel; Prades, Albert; Carr, Julie; Muller, Laurent; Jung, Boris; Belafia, Fouad; Cissé, Moussa; Delay, Jean-Marc; de Jong, Audrey; Lefrant, Jean-Yves; Futier, Emmanuel; Mercier, Grégoire; Molinari, Nicolas; Jaber, Samir

    2017-10-01

    Avoidance of excessive sedation and subsequent prolonged mechanical ventilation in intensive care units (ICUs) is recommended, but no data are available for critically ill postoperative patients. We hypothesised that in such patients stopping sedation immediately after admission to the ICU could reduce unnecessary sedation and improve patient outcomes. We did a randomised, parallel-group, clinical trial at three ICUs in France. Stratified randomisation with minimisation (1:1 via a restricted web platform) was used to assign eligible patients (aged ≥18 years, admitted to an ICU after abdominal surgery, and expected to require at least 12 h of mechanical ventilation because of a critical illness defined by a Sequential Organ Failure Assessment score >1 for any organ, but without severe acute respiratory distress syndrome or brain injury) to usual sedation care provided according to recommended practices (control group) or to immediate interruption of sedation (intervention group). The primary outcome was the time to successful extubation (defined as the time from randomisation to the time of extubation [or tracheotomy mask] for at least 48 h). All patients who underwent randomisation (except for those who were excluded after randomisation) were included in the intention-to-treat analysis. This study is registered with ClinicalTrials.gov, number NCT01486121. Between Dec 2, 2011, and Feb 27, 2014, 137 patients were randomly assigned to the control (n=68) or intervention groups (n=69). In the intention-to-treat analysis, time to successful extubation was significantly lower in the intervention group than in the control group (median 8 h [IQR 4-36] vs 50 h [29-93], group difference -33·6 h [95% CI -44·9 to -22·4]; p<0·0001). The adjusted hazard ratio was 5·2 (95% CI 3·1-8·8, p<0·0001). Immediate interruption of sedation in critically ill postoperative patients with organ dysfunction who were admitted to the ICU after abdominal surgery improved outcomes compared

  9. A randomised, parallel-group comparison study of diquafosol ophthalmic solution in patients with dry eye in China and Singapore.

    Science.gov (United States)

    Gong, Lan; Sun, Xinghuai; Ma, Zhizhong; Wang, Qinmei; Xu, Xun; Chen, Xiaoming; Shao, Yan; Yao, Ke; Tang, Luosheng; Gu, Yangshun; Yuan, Huiping; Chua, Wei Han; Chuan, Jacob Cheng Yen; Tong, Louis

    2015-07-01

    To compare the efficacy and safety of 3% diquafosol ophthalmic solution with those of 0.1% sodium hyaluronate ophthalmic solution in patients with dry eye in China and Singapore. A total of 497 patients with dry eye (Schirmer's test, 5 mm; fluorescein and RB score, 3 points) from China and Singapore were randomised to receive either diquafosol ophthalmic solution (diquafosol) or sodium hyaluronate ophthalmic solution (HA) at 1:1 ratio. The fluorescein staining scores and rose bengal (RB) subjective symptom scores and tear film breakup time were evaluated before treatment and 2 and 4 weeks after start of treatment. In the diquafosol group, changes in fluorescein and RB scores compared with baseline at week 4 or at the time of discontinuation were -2.1±1.5 and -2.5±2.0, respectively. Compared with the HA group, changes in fluorescein score were non-inferior and changes in RB score were superior (p=0.019). In addition, diquafosol and HA improved tear film breakup time by 1.046±1.797 and 0.832±1.775 s, respectively (no significant intergroup difference). Adverse event onset rates were 16.3% (40 of 246 subjects) and 10.0% (25 of 251 subjects) in the diquafosol group and HA group, respectively, with borderline significant intergroup differences (p=0.046), while adverse drug reaction incidence rates were 12.2% (30 of 246 subjects) and 6.0% (15 of 251 subjects), respectively (p=0.019). Only mild adverse drug reactions (>2%) in the form of eye discharge, itching or irritation were observed. Diquafosol improved fluorescein staining score in a manner similar to HA, and significantly improved RB score compared with HA. NCT01101984. 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.

  10. PC6 acupoint stimulation for the prevention of postcardiac surgery nausea and vomiting: a protocol for a two-group, parallel, superiority randomised clinical trial.

    Science.gov (United States)

    Cooke, Marie; Rickard, Claire; Rapchuk, Ivan; Shekar, Kiran; Marshall, Andrea P; Comans, Tracy; Doi, Suhail; McDonald, John; Spooner, Amy

    2014-11-13

    Postoperative nausea and vomiting (PONV) are frequent but unwanted complications for patients following anaesthesia and cardiac surgery, affecting at least a third of patients, despite pharmacological treatment. The primary aim of the proposed research is to test the efficacy of PC6 acupoint stimulation versus placebo for reducing PONV in cardiac surgery patients. In conjunction with this we aim to develop an understanding of intervention fidelity and factors that support, or impede, the use of PC6 acupoint stimulation, a knowledge translation approach. 712 postcardiac surgery participants will be recruited to take part in a two-group, parallel, superiority, randomised controlled trial. Participants will be randomised to receive a wrist band on each wrist providing acupressure to PC six using acupoint stimulation or a placebo. Randomisation will be computer generated, use randomly varied block sizes, and be concealed prior to the enrolment of each patient. The wristbands will remain in place for 36 h. PONV will be evaluated by the assessment of both nausea and vomiting, use of rescue antiemetics, quality of recovery and cost. Patient satisfaction with PONV care will be measured and clinical staff interviewed about the clinical use, feasibility, acceptability and challenges of using acupressure wristbands for PONV. Ethics approval will be sought from appropriate Human Research Ethics Committee/s before start of the study. A systematic review of the use of wrist acupressure for PC6 acupoint stimulation reported minor side effects only. Study progress will be reviewed by a Data Safety Monitoring Committee (DSMC) for nausea and vomiting outcomes at n=350. Dissemination of results will include conference presentations at national and international scientific meetings and publications in peer-reviewed journals. Study participants will receive a one-page lay-summary of results. Australian New Zealand Clinical Trials Registry--ACTRN12614000589684. Published by the BMJ

  11. A comparison of two treatments for childhood apraxia of speech: methods and treatment protocol for a parallel group randomised control trial

    Directory of Open Access Journals (Sweden)

    Murray Elizabeth

    2012-08-01

    Full Text Available Abstract Background Childhood Apraxia of Speech is an impairment of speech motor planning that manifests as difficulty producing the sounds (articulation and melody (prosody of speech. These difficulties may persist through life and are detrimental to academic, social, and vocational development. A number of published single subject and case series studies of speech treatments are available. There are currently no randomised control trials or other well designed group trials available to guide clinical practice. Methods/Design A parallel group, fixed size randomised control trial will be conducted in Sydney, Australia to determine the efficacy of two treatments for Childhood Apraxia of Speech: 1 Rapid Syllable Transition Treatment and the 2 Nuffield Dyspraxia Programme – Third edition. Eligible children will be English speaking, aged 4–12 years with a diagnosis of suspected CAS, normal or adjusted hearing and vision, and no comprehension difficulties or other developmental diagnoses. At least 20 children will be randomised to receive one of the two treatments in parallel. Treatments will be delivered by trained and supervised speech pathology clinicians using operationalised manuals. Treatment will be administered in 1-hour sessions, 4 times per week for 3 weeks. The primary outcomes are speech sound and prosodic accuracy on a customised 292 item probe and the Diagnostic Evaluation of Articulation and Phonology inconsistency subtest administered prior to treatment and 1 week, 1 month and 4 months post-treatment. All post assessments will be completed by blinded assessors. Our hypotheses are: 1 treatment effects at 1 week post will be similar for both treatments, 2 maintenance of treatment effects at 1 and 4 months post will be greater for Rapid Syllable Transition Treatment than Nuffield Dyspraxia Programme treatment, and 3 generalisation of treatment effects to untrained related speech behaviours will be greater for Rapid

  12. Effect of probiotic yoghurt on animal-based diet-induced change in gut microbiota: an open, randomised, parallel-group study.

    Science.gov (United States)

    Odamaki, T; Kato, K; Sugahara, H; Xiao, J Z; Abe, F; Benno, Y

    2016-09-01

    Diet has a significant influence on the intestinal environment. In this study, we assessed changes in the faecal microbiota induced by an animal-based diet and the effect of the ingestion of yoghurt supplemented with a probiotic strain on these changes. In total, 33 subjects were enrolled in an open, randomised, parallel-group study. After a seven-day pre-observation period, the subjects were allocated into three groups (11 subjects in each group). All of the subjects were provided with an animal-based diet for five days, followed by a balanced diet for 14 days. Subjects in the first group ingested dairy in the form of 200 g of yoghurt supplemented with Bifidobacterium longum during both the animal-based and balanced diet periods (YAB group). Subjects in the second group ingested yoghurt only during the balanced diet period (YB group). Subjects who did not ingest yoghurt throughout the intervention were used as the control (CTR) group. Faecal samples were collected before and after the animal-based diet was provided and after the balanced diet was provided, followed by analysis by high-throughput sequencing of amplicons derived from the V3-V4 region of the 16S rRNA gene. In the YB and CTR groups, the animal-based diet caused a significant increase in the relative abundance of Bilophila, Odoribacter, Dorea and Ruminococcus (belonging to Lachnospiraceae) and a significant decrease in the level of Bifidobacterium after five days of intake. With the exception of Ruminococcus, these changes were not observed in the YAB group. No significant effect was induced by yoghurt supplementation following an animal-based diet (YB group vs CTR group). These results suggest that the intake of yoghurt supplemented with bifidobacteria played a role in maintaining a normal microbiota composition during the ingestion of a meat-based diet. This study protocol was registered in the University Hospital Medical Information Network: UMIN000014164.

  13. Effectiveness of mobile phone messaging in prevention of type 2 diabetes by lifestyle modification in men in India: a prospective, parallel-group, randomised controlled trial.

    Science.gov (United States)

    Ramachandran, Ambady; Snehalatha, Chamukuttan; Ram, Jagannathan; Selvam, Sundaram; Simon, Mary; Nanditha, Arun; Shetty, Ananth Samith; Godsland, Ian F; Chaturvedi, Nish; Majeed, Azeem; Oliver, Nick; Toumazou, Christofer; Alberti, K George; Johnston, Desmond G

    2013-11-01

    Type 2 diabetes can often be prevented by lifestyle modification; however, successful lifestyle intervention programmes are labour intensive. Mobile phone messaging is an inexpensive alternative way to deliver educational and motivational advice about lifestyle modification. We aimed to assess whether mobile phone messaging that encouraged lifestyle change could reduce incident type 2 diabetes in Indian Asian men with impaired glucose tolerance. We did a prospective, parallel-group, randomised controlled trial between Aug 10, 2009, and Nov 30, 2012, at ten sites in southeast India. Working Indian men (aged 35-55 years) with impaired glucose tolerance were randomly assigned (1:1) with a computer-generated randomisation sequence to a mobile phone messaging intervention or standard care (control group). Participants in the intervention group received frequent mobile phone messages compared with controls who received standard lifestyle modification advice at baseline only. Field staff and participants were, by necessity, not masked to study group assignment, but allocation was concealed from laboratory personnel as well as principal and co-investigators. The primary outcome was incidence of type 2 diabetes, analysed by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00819455. We assessed 8741 participants for eligibility. 537 patients were randomly assigned to either the mobile phone messaging intervention (n=271) or standard care (n=266). The cumulative incidence of type 2 diabetes was lower in those who received mobile phone messages than in controls: 50 (18%) participants in the intervention group developed type 2 diabetes compared with 73 (27%) in the control group (hazard ratio 0·64, 95% CI 0·45-0·92; p=0·015). The number needed to treat to prevent one case of type 2 diabetes was 11 (95% CI 6-55). One patient in the control group died suddenly at the end of the first year. We recorded no other serious adverse events. Mobile

  14. A randomised, single-blind, single-dose, three-arm, parallel-group study in healthy subjects to demonstrate pharmacokinetic equivalence of ABP 501 and adalimumab.

    Science.gov (United States)

    Kaur, Primal; Chow, Vincent; Zhang, Nan; Moxness, Michael; Kaliyaperumal, Arunan; Markus, Richard

    2017-03-01

    To demonstrate pharmacokinetic (PK) similarity of biosimilar candidate ABP 501 relative to adalimumab reference product from the USA and European Union (EU) and evaluate safety, tolerability and immunogenicity of ABP 501. Randomised, single-blind, single-dose, three-arm, parallel-group study; healthy subjects were randomised to receive ABP 501 (n=67), adalimumab (USA) (n=69) or adalimumab (EU) (n=67) 40 mg subcutaneously. Primary end points were area under the serum concentration-time curve from time 0 extrapolated to infinity (AUC inf ) and the maximum observed concentration (C max ). Secondary end points included safety and immunogenicity. AUC inf and C max were similar across the three groups. Geometrical mean ratio (GMR) of AUC inf was 1.11 between ABP 501 and adalimumab (USA), and 1.04 between ABP 501 and adalimumab (EU). GMR of C max was 1.04 between ABP 501 and adalimumab (USA) and 0.96 between ABP 501 and adalimumab (EU). The 90% CIs for the GMRs of AUC inf and C max were within the prespecified standard PK equivalence criteria of 0.80 to 1.25. Treatment-related adverse events were mild to moderate and were reported for 35.8%, 24.6% and 41.8% of subjects in the ABP 501, adalimumab (USA) and adalimumab (EU) groups; incidence of antidrug antibodies (ADAbs) was similar among the study groups. Results of this study demonstrated PK similarity of ABP 501 with adalimumab (USA) and adalimumab (EU) after a single 40-mg subcutaneous injection. No new safety signals with ABP 501 were identified. The safety and tolerability of ABP 501 was similar to the reference products, and similar ADAb rates were observed across the three groups. EudraCT number 2012-000785-37; Results. 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. Emollient bath additives for the treatment of childhood eczema (BATHE): multicentre pragmatic parallel group randomised controlled trial of clinical and cost effectiveness.

    Science.gov (United States)

    Santer, Miriam; Ridd, Matthew J; Francis, Nick A; Stuart, Beth; Rumsby, Kate; Chorozoglou, Maria; Becque, Taeko; Roberts, Amanda; Liddiard, Lyn; Nollett, Claire; Hooper, Julie; Prude, Martina; Wood, Wendy; Thomas, Kim S; Thomas-Jones, Emma; Williams, Hywel C; Little, Paul

    2018-05-03

    To determine the clinical effectiveness and cost effectiveness of including emollient bath additives in the management of eczema in children. Pragmatic randomised open label superiority trial with two parallel groups. 96 general practices in Wales and western and southern England. 483 children aged 1 to 11 years, fulfilling UK diagnostic criteria for atopic dermatitis. Children with very mild eczema and children who bathed less than once weekly were excluded. Participants in the intervention group were prescribed emollient bath additives by their usual clinical team to be used regularly for 12 months. The control group were asked to use no bath additives for 12 months. Both groups continued with standard eczema management, including leave-on emollients, and caregivers were given standardised advice on how to wash participants. The primary outcome was eczema control measured by the patient oriented eczema measure (POEM, scores 0-7 mild, 8-16 moderate, 17-28 severe) weekly for 16 weeks. Secondary outcomes were eczema severity over one year (monthly POEM score from baseline to 52 weeks), number of eczema exacerbations resulting in primary healthcare consultation, disease specific quality of life (dermatitis family impact), generic quality of life (child health utility-9D), utilisation of resources, and type and quantity of topical corticosteroid or topical calcineurin inhibitors prescribed. 483 children were randomised and one child was withdrawn, leaving 482 children in the trial: 51% were girls (244/482), 84% were of white ethnicity (447/470), and the mean age was 5 years. 96% (461/482) of participants completed at least one post-baseline POEM, so were included in the analysis, and 77% (370/482) completed questionnaires for more than 80% of the time points for the primary outcome (12/16 weekly questionnaires to 16 weeks). The mean baseline POEM score was 9.5 (SD 5.7) in the bath additives group and 10.1 (SD 5.8) in the no bath additives group. The mean POEM score

  16. Rasagiline as an adjunct to levodopa in patients with Parkinson's disease and motor fluctuations (LARGO, Lasting effect in Adjunct therapy with Rasagiline Given Once daily, study): a randomised, double-blind, parallel-group trial.

    OpenAIRE

    Rascol, O.; Brooks, D.J.; Melamed, E.; Oertel, W.; Poewe, W.; Stocchi, F.; Tolosa, E.; LARGO study group

    2005-01-01

    Lancet. 2005 Mar 12-18;365(9463):947-54. Rasagiline as an adjunct to levodopa in patients with Parkinson's disease and motor fluctuations (LARGO, Lasting effect in Adjunct therapy with Rasagiline Given Once daily, study): a randomised, double-blind, parallel-group trial. Rascol O, Brooks DJ, Melamed E, Oertel W, Poewe W, Stocchi F, Tolosa E; LARGO study group. Clinical Investigation Centre, Department of Clinical Pharmacology, University Hospital, Toulouse, France. ...

  17. 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

  18. Mesh, graft, or standard repair for women having primary transvaginal anterior or posterior compartment prolapse surgery: two parallel-group, multicentre, randomised, controlled trials (PROSPECT).

    Science.gov (United States)

    Glazener, Cathryn Ma; Breeman, Suzanne; Elders, Andrew; Hemming, Christine; Cooper, Kevin G; Freeman, Robert M; Smith, Anthony Rb; Reid, Fiona; Hagen, Suzanne; Montgomery, Isobel; Kilonzo, Mary; Boyers, Dwayne; McDonald, Alison; McPherson, Gladys; MacLennan, Graeme; Norrie, John

    2017-01-28

    The use of transvaginal mesh and biological graft material in prolapse surgery is controversial and has led to a number of enquiries into their safety and efficacy. Existing trials of these augmentations are individually too small to be conclusive. We aimed to compare the outcomes of prolapse repair involving either synthetic mesh inlays or biological grafts against standard repair in women. We did two pragmatic, parallel-group, multicentre, randomised controlled trials for our study (PROSPECT [PROlapse Surgery: Pragmatic Evaluation and randomised Controlled Trials]) in 35 centres (a mix of secondary and tertiary referral hospitals) in the UK. We recruited women undergoing primary transvaginal anterior or posterior compartment prolapse surgery by 65 gynaecological surgeons in these centres. We randomly assigned participants by a remote web-based randomisation system to one of the two trials: comparing standard (native tissue) repair alone with standard repair augmented with either synthetic mesh (the mesh trial) or biological graft (the graft trial). We assigned women (1:1:1 or 1:1) within three strata: assigned to one of the three treatment options, comparison of standard repair with mesh, and comparison of standard repair with graft. Participants, ward staff, and outcome assessors were masked to randomisation where possible; masking was obviously not possible for the surgeon. Follow-up was for 2 years after the surgery; the primary outcomes, measured at 1 year and 2 years, were participant-reported prolapse symptoms (i.e. the Pelvic Organ Prolapse Symptom Score [POP-SS]) and condition-specific (ie, prolapse-related) quality-of-life scores, analysed in the modified intention-to-treat population. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN60695184. Between Jan 8, 2010, and Aug 30, 2013, we randomly allocated 1352 women to treatment, of whom 1348 were included in the analysis. 865 women were included in the mesh

  19. Budesonide/formoterol as effective as prednisolone plus formoterol in acute exacerbations of COPD A double-blind, randomised, non-inferiority, parallel-group, multicentre study

    Directory of Open Access Journals (Sweden)

    Andersson Eva

    2009-02-01

    Full Text Available Abstract Background Oral corticosteroids and inhaled bronchodilators with or without antibiotics represent standard treatment of COPD exacerbations of moderate severity. Frequent courses of oral steroids may be a safety issue. We wanted to evaluate in an out-patient setting whether a 2-week course of inhaled budesonide/formoterol would be equally effective for treatment of acute COPD exacerbations as standard therapy in patients judged by the investigator not to require hospitalisation. Methods This was a double-blind, randomised, non-inferiority, parallel-group, multicentre study comparing two treatment strategies; two weeks' treatment with inhaled budesonide/formoterol (320/9 μg, qid was compared with prednisolone (30 mg once daily plus inhaled formoterol (9 μg bid in patients with acute exacerbations of COPD attending a primary health care centre. Inclusion criteria were progressive dyspnoea for less than one week, FEV1 30–60% of predicted normal after acute treatment with a single dose of oral corticosteroid plus nebulised salbutamol/ipratropium bromide and no requirement for subsequent immediate hospitalisation, i.e the clinical status after the acute treatment allowed for sending the patient home. A total of 109 patients (mean age 67 years, 33 pack-years, mean FEV1 45% of predicted were randomized to two weeks' double-blind treatment with budesonide/formoterol or prednisolone plus formoterol and subsequent open-label budesonide/formoterol (320/9 μg bid for another 12 weeks. Change in FEV1 was the primary efficacy variable. Non-inferiority was predefined. Results Non-inferiority of budesonide/formoterol was proven because the lower limit of FEV1-change (97.5% CI was above 90% of the efficacy of the alternative treatment. Symptoms, quality of life, treatment failures, need for reliever medication (and exacerbations during follow-up did not differ between the groups. No safety concerns were identified. Conclusion High dose budesonide

  20. Evaluation of wet-cupping therapy for persistent non-specific low back pain: a randomised, waiting-list controlled, open-label, parallel-group pilot trial

    Directory of Open Access Journals (Sweden)

    Kim Kun

    2011-06-01

    Full Text Available Abstract Background Persistent non-specific low back pain (PNSLBP is one of the most frequently experienced types of back pain around the world. Wet-cupping is a common intervention for various pain conditions, especially in Korea. In this context, we conducted a pilot study to determine the effectiveness and safety of wet-cupping treatment for PNSLBP. Methods We recruited 32 participants (21 in the wet-cupping group and 11 in the waiting-list group who had been having PNSLBP for at least 3 months. The participants were recruited at the clinical research centre of the Korea Institute of Oriental Medicine, Korea. Eligible participants were randomly allocated to wet-cupping and waiting-list groups. Following the practice of traditional Korean medicine, the treatment group was provided with wet-cupping treatment at two acupuncture points among the BL23, BL24 and BL25 6 times within 2 weeks. Usual care, including providing brochures for exercise, general advice for PNSLBP and acetaminophen, was allowed in both groups. Separate assessors participated in the outcome assessment. We used the 0 to100 numerical rating scale (NRS for pain, the McGill Pain Questionnaire for pain intensity (PPI and the Oswestry Disability Questionnaire (ODQ, and we assessed acetaminophen use and safety issues. Results The results showed that the NRS score for pain decreased (-16.0 [95% CI: -24.4 to -7.7] in the wet-cupping group and -9.1 [-18.1 to -0.1] in the waiting-list group, but there was no statistical difference between the groups (p = 0.52. However, the PPI scores showed significant differences between the two groups (-1.2 [-1.6 to -0.8] for the wet-cupping group and -0.2 [-0.8 to 0.4] for the waiting-list group, p Conclusion This pilot study may provide preliminary data on the effectiveness and safety of wet-cupping treatments for PNSLBP. Future full-scale randomised controlled trials will be needed to provide firm evidence of the effectiveness of this intervention

  1. Evaluation of wet-cupping therapy for persistent non-specific low back pain: a randomised, waiting-list controlled, open-label, parallel-group pilot trial.

    Science.gov (United States)

    Kim, Jong-In; Kim, Tae-Hun; Lee, Myeong Soo; Kang, Jung Won; Kim, Kun Hyung; Choi, Jun-Yong; Kang, Kyung-Won; Kim, Ae-Ran; Shin, Mi-Suk; Jung, So-Young; Choi, Sun-mi

    2011-06-10

    Persistent non-specific low back pain (PNSLBP) is one of the most frequently experienced types of back pain around the world. Wet-cupping is a common intervention for various pain conditions, especially in Korea. In this context, we conducted a pilot study to determine the effectiveness and safety of wet-cupping treatment for PNSLBP. We recruited 32 participants (21 in the wet-cupping group and 11 in the waiting-list group) who had been having PNSLBP for at least 3 months. The participants were recruited at the clinical research centre of the Korea Institute of Oriental Medicine, Korea. Eligible participants were randomly allocated to wet-cupping and waiting-list groups. Following the practice of traditional Korean medicine, the treatment group was provided with wet-cupping treatment at two acupuncture points among the BL23, BL24 and BL25 6 times within 2 weeks. Usual care, including providing brochures for exercise, general advice for PNSLBP and acetaminophen, was allowed in both groups. Separate assessors participated in the outcome assessment. We used the 0 to 100 numerical rating scale (NRS) for pain, the McGill Pain Questionnaire for pain intensity (PPI) and the Oswestry Disability Questionnaire (ODQ), and we assessed acetaminophen use and safety issues. The results showed that the NRS score for pain decreased (-16.0 [95% CI: -24.4 to -7.7] in the wet-cupping group and -9.1 [-18.1 to -0.1] in the waiting-list group), but there was no statistical difference between the groups (p = 0.52). However, the PPI scores showed significant differences between the two groups (-1.2 [-1.6 to -0.8] for the wet-cupping group and -0.2 [-0.8 to 0.4] for the waiting-list group, p cupping group during 4 weeks (p = 0.09). The ODQ score did not show significant differences between the two groups (-5.60 [-8.90 to -2.30] in the wet-cupping group and -1.8 [-5.8 to 2.2] in the waiting-list group, p = 0.14). There was no report of adverse events due to wet-cupping. This pilot study may

  2. Restricted versus continued standard caloric intake during the management of refeeding syndrome in critically ill adults: a randomised, parallel-group, multicentre, single-blind controlled trial.

    Science.gov (United States)

    Doig, Gordon S; Simpson, Fiona; Heighes, Philippa T; Bellomo, Rinaldo; Chesher, Douglas; Caterson, Ian D; Reade, Michael C; Harrigan, Peter W J

    2015-12-01

    Equipoise exists regarding the benefits of restricting caloric intake during electrolyte replacement for refeeding syndrome, with half of intensive care specialists choosing to continue normal caloric intake. We aimed to assess whether energy restriction affects the duration of critical illness, and other measures of morbidity, compared with standard care. We did a randomised, multicentre, single-blind clinical trial in 13 hospital intensive care units (ICUs) in Australia (11 sites) and New Zealand (two sites). Adult critically ill patients who developed refeeding syndrome within 72 h of commencing nutritional support in the ICU were enrolled and allocated to receive continued standard nutritional support or protocolised caloric restriction. 1:1 computer-based randomisation was done in blocks of variable size, stratified by enrolment serum phosphate concentration (>0·32 mmol/L vs ≤0·32 mmol/L) and body-mass index (BMI; >18 kg/m(2)vs ≤18 kg/m(2)). The primary outcome was the number of days alive after ICU discharge, with 60 day follow-up, in a modified intention-to-treat population of all randomly allocated patients except those mistakenly enrolled. Days alive after ICU discharge was a composite outcome based on ICU length of stay, overall survival time, and mortality. The Refeeding Syndrome Trial was registered with the Australian and New Zealand Clinical Trials Registry (ANZCTR number 12609001043224). Between Dec 3, 2010, and Aug 13, 2014, we enrolled 339 adult critically ill patients: 170 were randomly allocated to continued standard nutritional support and 169 to protocolised caloric restriction. During the 60 day follow-up, the mean number of days alive after ICU discharge in 165 assessable patients in the standard care group was 39·9 (95% CI 36·4-43·7) compared with 44·8 (95% CI 40·9-49·1) in 166 assessable patients in the caloric restriction group (difference 4·9 days, 95% CI -2·3 to 13·6, p=0·19). Nevertheless, protocolised caloric

  3. A National Quality Improvement Collaborative for the clinical use of outcome measurement in specialised mental healthcare: results from a parallel group design and a nested cluster randomised controlled trial.

    Science.gov (United States)

    Metz, Margot J; Veerbeek, Marjolein A; Franx, Gerdien C; van der Feltz-Cornelis, Christina M; de Beurs, Edwin; Beekman, Aartjan T F

    2017-05-01

    Although the importance and advantages of measurement-based care in mental healthcare are well established, implementation in daily practice is complex and far from optimal. To accelerate the implementation of outcome measurement in routine clinical practice, a government-sponsored National Quality Improvement Collaborative was initiated in Dutch-specialised mental healthcare. To investigate the effects of this initiative, we combined a matched-pair parallel group design (21 teams) with a cluster randomised controlled trial (RCT) (6 teams). At the beginning and end, the primary outcome 'actual use and perceived clinical utility of outcome measurement' was assessed. In both designs, intervention teams demonstrated a significant higher level of implementation of outcome measurement than control teams. Overall effects were large (parallel group d =0.99; RCT d =1.25). The National Collaborative successfully improved the use of outcome measurement in routine clinical practice. None. © The Royal College of Psychiatrists 2017. This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) license.

  4. A multicentre, pragmatic, parallel group, randomised controlled trial to compare the clinical and cost-effectiveness of three physiotherapy-led exercise interventions for knee osteoarthritis in older adults: the BEEP trial protocol (ISRCTN: 93634563).

    Science.gov (United States)

    Foster, Nadine E; Healey, Emma L; Holden, Melanie A; Nicholls, Elaine; Whitehurst, David Gt; Jowett, Susan; Jinks, Clare; Roddy, Edward; Hay, Elaine M

    2014-07-27

    Exercise is consistently recommended for older adults with knee pain related to osteoarthritis. However, the effects from exercise are typically small and short-term, likely linked to insufficient individualisation of the exercise programme and limited attention to supporting exercise adherence over time. The BEEP randomised trial aims to improve patients' short and long-term outcomes from exercise. It will test the overall effectiveness and cost-effectiveness of two physiotherapy-led exercise interventions (Individually Tailored Exercise and Targeted Exercise Adherence) to improve the individual tailoring of, and adherence to exercise, compared with usual physiotherapy care. Based on the learning from a pilot study (ISRCTN 23294263), the BEEP trial is a multi-centre, pragmatic, parallel group, individually randomised controlled trial, with embedded longitudinal qualitative interviews. 500 adults in primary care, aged 45 years and over with knee pain will be randomised to 1 of 3 treatment groups delivered by fully trained physiotherapists in up to 6 NHS services. These are: Usual Physiotherapy Care (control group consisting of up to 4 treatment sessions of advice and exercise), Individually Tailored Exercise (an individualised, supervised and progressed lower-limb exercise programme) or Targeted Exercise Adherence (supporting patients to adhere to exercise and to engage in general physical activity over the longer-term). The primary outcomes are pain and function as measured by the Western Ontario and McMaster Osteoarthritis index. A comprehensive range of secondary outcomes are also included. Outcomes are measured at 3, 6 (primary outcome time-point), 9, 18 and 36 months. Data on adverse events will also be collected. Semi-structured, qualitative interviews with a subsample of 30 participants (10 from each treatment group) will be undertaken at two time-points (end of treatment and 12 to 18 months later) and analysed thematically. This trial will contribute to the

  5. 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...

  6. Effectiveness of telemedicine and distance learning applications for patients with chronic heart failure. A protocol for prospective parallel group non-randomised open label study

    OpenAIRE

    Vanagas, Giedrius; Umbrasienė, Jelena; Šlapikas, Rimvydas

    2012-01-01

    Introduction Chronic heart failure in Baltic Sea Region is responsible for more hospitalisations than all forms of cancer combined and is one of the leading causes of hospitalisations in elderly patients. Frequent hospitalisations, along with other direct and indirect costs, place financial burden on healthcare systems. We aim to test the hypothesis that telemedicine and distance learning applications is superior to the current standard of home care. Methods and analysis Prospective parallel ...

  7. Effectiveness of a ‘Workshop on Decluttering and Organising’ programme for teens and middle-aged adults with difficulty decluttering: a study protocol of an open-label, randomised, parallel-group, superiority trial in Japan

    Science.gov (United States)

    Aso, Yasuko; Yamaoka, Kazue; Nemoto, Asuka; Naganuma, Yuki; Saito, Masashige

    2017-01-01

    Introduction Hoarding disorder can cause problems with work performance, personal hygiene, health and well-being. The disorder is a growing social problem in Japan. Having difficulty discarding rubbish, decluttering and organising can signal a future hoarding disorder, and early intervention is important. We developed an educational workshop on decluttering and organising for teens and adults with difficulty organising. The objective of this study is to evaluate the effectiveness of a workshop for reducing clutter and improving quality of life among younger people with difficulty decluttering and organising. Methods and analysis An open-label, parallel-group, randomised controlled trial will be conducted among volunteers aged 12–55 years with mild difficulty decluttering and organising. Those in the intervention group will attend the workshop and receive a visit from a professional cleaning company to declutter their living space. The control group will have only the latter. The primary outcome will be the score on the Japanese version of the Saving Inventory-Revised. Secondary outcomes will be scores on the Clutter Image Rating Scale, the Japanese version of the Rosenberg Self-Esteem Scale and the Roles of Private Space Scale. The results will be examined for differences between the two groups in changes from baseline to 7 months. We will examine crude effects and adjust for gender and age using a general linear model for continuous variables and a logistic regression model for dichotomous variables. Sample size was calculated assuming a significance level of 5% (two tailed), a power of 80% and an effect size of 0.75. In total, 60 subjects (30 in each group) will be required. Ethics and dissemination The study protocol has been approved by the Medical Ethical Committee of Teikyo University (No. 15-065). The findings will be disseminated widely through peer-reviewed publication and conference presentations. Trial registration number UMIN000020568. Issue date: 16

  8. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study.

    Science.gov (United States)

    Park, Won; Hrycaj, Pawel; Jeka, Slawomir; Kovalenko, Volodymyr; Lysenko, Grygorii; Miranda, Pedro; Mikazane, Helena; Gutierrez-Ureña, Sergio; Lim, MieJin; Lee, Yeon-Ah; Lee, Sang Joon; Kim, HoUng; Yoo, Dae Hyun; Braun, Jürgen

    2013-10-01

    To compare the pharmacokinetics (PK), safety and efficacy of innovator infliximab (INX) and CT-P13, a biosimilar to INX, in patients with active ankylosing spondylitis (AS). Phase 1 randomised, double-blind, multicentre, multinational, parallel-group study. Patients were randomised to receive 5 mg/kg of CT-P13 (n=125) or INX (n=125). Primary endpoints were area under the concentration-time curve (AUC) at steady state and observed maximum steady state serum concentration (Cmax,ss) between weeks 22 and 30. Additional PK, efficacy endpoints, including 20% and 40% improvement response according to Assessment in Ankylosing Spondylitis International Working Group criteria (ASAS20 and ASAS40), and safety outcomes were also assessed. Geometric mean AUC was 32 765.8 μgh/ml for CT-P13 and 31 359.3 μgh/ml for INX. Geometric mean Cmax,ss was 147.0 μg/ml for CT-P13 and 144.8 μg/ml for INX. The ratio of geometric means was 104.5% (90% CI 94% to 116%) for AUC and 101.5% (90% CI 95% to 109%) for Cmax,ss. ASAS20 and ASAS40 responses at week 30 were 70.5% and 51.8% for CT-P13 and 72.4% and 47.4% for INX, respectively. In the CT-P13 and INX groups more than one adverse event occurred in 64.8% and 63.9% of patients, infusion reactions occurred in 3.9% and 4.9%, active tuberculosis occurred in 1.6% and 0.8%, and 27.4% and 22.5% of patients tested positive for anti-drug antibodies, respectively. The PK profiles of CT-P13 and INX were equivalent in patients with active AS. CT-P13 was well tolerated, with an efficacy and safety profile comparable to that of INX up to week 30.

  9. Effect of an interactive text-messaging service on patient retention during the first year of HIV care in Kenya (WelTel Retain): an open-label, randomised parallel-group study.

    Science.gov (United States)

    van der Kop, Mia Liisa; Muhula, Samuel; Nagide, Patrick I; Thabane, Lehana; Gelmon, Lawrence; Awiti, Patricia Opondo; Abunah, Bonface; Kyomuhangi, Lennie Bazira; Budd, Matthew A; Marra, Carlo; Patel, Anik; Karanja, Sarah; Ojakaa, David I; Mills, Edward J; Ekström, Anna Mia; Lester, Richard Todd

    2018-03-01

    Retention of patients in HIV care is crucial to ensure timely treatment initiation, viral suppression, and to avert AIDS-related deaths. We did a randomised trial to determine whether a text-messaging intervention improved retention during the first year of HIV care. This unmasked, randomised parallel-group study was done at two clinics in informal settlements in Nairobi, Kenya. Eligible participants were aged 18 years or older, HIV-positive, had their own mobile phone or access to one, and were able to use simple text messaging (or have somebody who could text message on their behalf). Participants were randomly assigned (1:1), with random block sizes of 2, 4, and 6, to the intervention or control group. Participants in the intervention group received a weekly text message from the automated WelTel service for 1 year and were asked to respond within 48 h. Participants in the control group did not receive text messages. Participants in both groups received usual care, which comprised psychosocial support and counselling; patient education; CD4 cell count; treatment; screening for tuberculosis, opportunistic infections, and sexually transmitted infections; prevention of mother-to-child transmission and family planning services; and up to two telephone calls for missed appointments. The primary outcome was retention in care at 12 months (ie, clinic attendance 10-14 months after the first visit). Participants who did not attend this 12-month appointment were traced, and we considered as retained those who were confirmed to be active in care elsewhere. The data analyst and clinic staff were masked to the group assignment, whereas participants and research nurses were not. We analysed the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT01630304. Between April 4, 2013, and June 4, 2015, we screened 1068 individuals, of whom 700 were recruited. 349 people were allocated to the intervention group and 351 to the control group

  10. Effectiveness of a 'Workshop on Decluttering and Organising' programme for teens and middle-aged adults with difficulty decluttering: a study protocol of an open-label, randomised, parallel-group, superiority trial in Japan.

    Science.gov (United States)

    Aso, Yasuko; Yamaoka, Kazue; Nemoto, Asuka; Naganuma, Yuki; Saito, Masashige

    2017-06-10

    Hoarding disorder can cause problems with work performance, personal hygiene, health and well-being. The disorder is a growing social problem in Japan. Having difficulty discarding rubbish, decluttering and organising can signal a future hoarding disorder, and early intervention is important. We developed an educational workshop on decluttering and organising for teens and adults with difficulty organising. The objective of this study is to evaluate the effectiveness of a workshop for reducing clutter and improving quality of life among younger people with difficulty decluttering and organising. An open-label, parallel-group, randomised controlled trial will be conducted among volunteers aged 12-55 years with mild difficulty decluttering and organising. Those in the intervention group will attend the workshop and receive a visit from a professional cleaning company to declutter their living space. The control group will have only the latter. The primary outcome will be the score on the Japanese version of the Saving Inventory-Revised. Secondary outcomes will be scores on the Clutter Image Rating Scale, the Japanese version of the Rosenberg Self-Esteem Scale and the Roles of Private Space Scale. The results will be examined for differences between the two groups in changes from baseline to 7 months. We will examine crude effects and adjust for gender and age using a general linear model for continuous variables and a logistic regression model for dichotomous variables. Sample size was calculated assuming a significance level of 5% (two tailed), a power of 80% and an effect size of 0.75. In total, 60 subjects (30 in each group) will be required. The study protocol has been approved by the Medical Ethical Committee of Teikyo University (No. 15-065). The findings will be disseminated widely through peer-reviewed publication and conference presentations. UMIN000020568. Issue date: 16 January 2016. © Article author(s) (or their employer(s) unless otherwise stated in the

  11. Safety and efficacy of rasagiline as an add-on therapy to riluzole in patients with amyotrophic lateral sclerosis: a randomised, double-blind, parallel-group, placebo-controlled, phase 2 trial.

    Science.gov (United States)

    Ludolph, Albert C; Schuster, Joachim; Dorst, Johannes; Dupuis, Luc; Dreyhaupt, Jens; Weishaupt, Jochen H; Kassubek, Jan; Weiland, Ulrike; Petri, Susanne; Meyer, Thomas; Grosskreutz, Julian; Schrank, Berthold; Boentert, Matthias; Emmer, Alexander; Hermann, Andreas; Zeller, Daniel; Prudlo, Johannes; Winkler, Andrea S; Grehl, Torsten; Heneka, Michael T; Wollebæk Johannesen, Siw; Göricke, Bettina

    2018-06-18

    Rasagiline, a monoamine oxidase B inhibitor with neuroprotective potential in Parkinson's disease, has shown a disease-modifying effect in the SOD1-Gly93Ala low-expressing mouse model of amyotrophic lateral sclerosis, both alone and in combination with riluzole. We sought to test whether or not rasagiline 1 mg/day can prolong survival in patients with amyotrophic lateral sclerosis also receiving riluzole. Patients with possible, probable, or definite amyotrophic lateral sclerosis were enrolled to our randomised, placebo-controlled, parallel-group, double-blind, phase 2 trial from 15 German network for motor neuron diseases (MND-NET) centres (university hospitals or clinics). Eligible patients were aged at least 18 years, had onset of progressive weakness within the 36 months before the study, had disease duration of more than 6 months and less than 3 years, and had a best-sitting slow vital capacity of at least 50%. After a 4-week screening period, eligible patients were randomly assigned (1:1) to receive either rasagiline (1 mg/day) or placebo in addition to riluzole (100 mg/day), after stratification for site of onset (bulbar or spinal) and study centre. Patients and all personnel assessing outcome parameters were masked to treatment allocation. Patients were followed up 2, 6, 12, and 18 months after randomisation. The primary endpoint was survival time, defined as the time to death or time to study cutoff date (ie, the last patient's last visit plus 14 days). Analyses of primary outcome and safety measures were done in all patients who received at least one dose of trial treatment (intention-to-treat population). The trial is registered with ClinicalTrials.gov, number NCT01879241. Between July 2, 2013, and Nov 11, 2014, 273 patients were screened for eligibility, and 252 patients were randomly assigned to receive rasagiline (n=127) or placebo (n=125). 126 patients taking rasagiline and 125 taking placebo were included in the intention-to-treat analysis. For the

  12. RAPP, a systematic e-assessment of postoperative recovery in patients undergoing day surgery: study protocol for a mixed-methods study design including a multicentre, two-group, parallel, single-blind randomised controlled trial and qualitative interview studies.

    Science.gov (United States)

    Nilsson, U; Jaensson, M; Dahlberg, K; Odencrants, S; Grönlund, Å; Hagberg, L; Eriksson, M

    2016-01-13

    Day surgery is a well-established practice in many European countries, but only limited information is available regarding postoperative recovery at home though there is a current lack of a standard procedure regarding postoperative follow-up. Furthermore, there is also a need for improvement of modern technology in assessing patient-related outcomes such as mobile applications. This article describes the Recovery Assessment by Phone Points (RAPP) study protocol, a mixed-methods study to evaluate if a systematic e-assessment follow-up in patients undergoing day surgery is cost-effective and improves postoperative recovery, health and quality of life. This study has a mixed-methods study design that includes a multicentre, two-group, parallel, single-blind randomised controlled trial and qualitative interview studies. 1000 patients >17 years of age who are undergoing day surgery will be randomly assigned to either e-assessed postoperative recovery follow-up daily in 14 days measured via smartphone app including the Swedish web-version of Quality of Recovery (SwQoR) or to standard care (ie, no follow-up). The primary aim is cost-effectiveness. Secondary aims are (A) to explore whether a systematic e-assessment follow-up after day surgery has a positive effect on postoperative recovery, health-related quality of life (QoL) and overall health; (B) to determine whether differences in postoperative recovery have an association with patient characteristic, type of surgery and anaesthesia; (C) to determine whether differences in health literacy have a substantial and distinct effect on postoperative recovery, health and QoL; and (D) to describe day surgery patient and staff experiences with a systematic e-assessment follow-up after day surgery.The primary aim will be measured at 2 weeks postoperatively and secondary outcomes (A-C) at 1 and 2 weeks and (D) at 1 and 4 months. NCT02492191; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use

  13. LDL-cholesterol lowering activity of a blend of rice bran oil and safflower oil (8:2) in patients with hyperlipidaemia: a proof of concept, double blind, controlled, randomised parallel group study.

    Science.gov (United States)

    Malve, Harshad; Kerkar, Prafulla; Mishra, Nidheesh; Loke, Sanjita; Rege, N N; Marwaha-Jaspal, Ankita; Jainani, Kiran J

    2010-11-01

    Cardiovascular diseases have emerged as major health burden worldwide in recent times. Low density lipoprotein cholesterol (LDL-C) serves as the primary marker for cardiovascular diseases. Reports suggest that rice bran oil has antihyperlipidaemic properties. However, current evidence suggests that no single oil can provide the recommended dietary fat ratio. Hence the present study was undertaken in patients with hyperlipidaemia to study effects of substitution of the cooking oil with a blend of 80% rice bran oil and 20% safflower oil on LDL-C levels. The selected patients (n = 73) were randomly assigned either to the study oil group (blend under study) or control oil group (the oil which the patient was using before). The lipid profile was monitored monthly in these patients for 3 months during which they consumed the oil as per the randomisation. At each follow up, LDL-C levels showed a significant reduction from baseline in the study oil group and reduction was more than that observed in the control group. It was also observed that the percentage of the respondents was higher in the study oil group. At the end of the study period, 82% patients from this group had LDL levels less than 150 mg% as against 57% in the control group. Thus, the substitution of usual cooking oil with a blend of rice bran oil and safflower oil (8:2) was found to exert beneficial effects on the LDL-C levels shifting them to low-risk lipid category.

  14. Parallel computational in nuclear group constant calculation

    International Nuclear Information System (INIS)

    Su'ud, Zaki; Rustandi, Yaddi K.; Kurniadi, Rizal

    2002-01-01

    In this paper parallel computational method in nuclear group constant calculation using collision probability method will be discuss. The main focus is on the calculation of collision matrix which need large amount of computational time. The geometry treated here is concentric cylinder. The calculation of collision probability matrix is carried out using semi analytic method using Beckley Naylor Function. To accelerate computation speed some computer parallel used to solve the problem. We used LINUX based parallelization using PVM software with C or fortran language. While in windows based we used socket programming using DELPHI or C builder. The calculation results shows the important of optimal weight for each processor in case there area many type of processor speed

  15. BREATHER (PENTA 16) short-cycle therapy (SCT) (5 days on/2 days off) in young people with chronic human immunodeficiency virus infection: an open, randomised, parallel-group Phase II/III trial.

    Science.gov (United States)

    Butler, Karina; Inshaw, Jamie; Ford, Deborah; Bernays, Sarah; Scott, Karen; Kenny, Julia; Klein, Nigel; Turkova, Anna; Harper, Lynda; Nastouli, Eleni; Paparini, Sara; Choudhury, Rahela; Rhodes, Tim; Babiker, Abdel; Gibb, Diana

    2016-06-01

    For human immunodeficiency virus (HIV)-infected adolescents facing lifelong antiretroviral therapy (ART), short-cycle therapy (SCT) with long-acting agents offers the potential for drug-free weekends, less toxicity, better adherence and cost savings. To determine whether or not efavirenz (EFV)-based ART in short cycles of 5 days on and 2 days off is as efficacious (in maintaining virological suppression) as continuous EFV-based ART (continuous therapy; CT). Secondary objectives included the occurrence of new clinical HIV events or death, changes in immunological status, emergence of HIV drug resistance, drug toxicity and changes in therapy. Open, randomised, non-inferiority trial. Europe, Thailand, Uganda, Argentina and the USA. Young people (aged 8-24 years) on EFV plus two nucleoside reverse transcriptase inhibitors and with a HIV-1 ribonucleic acid level [viral load (VL)] of  12 months. Young people were randomised to continue daily ART (CT) or change to SCT (5 days on, 2 days off ART). Follow-up was for a minimum of 48 weeks (0, 4 and 12 weeks and then 12-weekly visits). The primary outcome was the difference between arms in the proportion with VL > 50 copies/ml (confirmed) by 48 weeks, estimated using the Kaplan-Meier method (12% non-inferiority margin) adjusted for region and age. In total, 199 young people (11 countries) were randomised (n = 99 SCT group, n = 100 CT group) and followed for a median of 86 weeks. Overall, 53% were male; the median age was 14 years (21% ≥ 18 years); 13% were from the UK, 56% were black, 19% were Asian and 21% were Caucasian; and the median CD4% and CD4 count were 34% and 735 cells/mm(3), respectively. By week 48, only one participant (CT) was lost to follow-up. The SCT arm had a 27% decreased drug exposure as measured by the adherence questionnaire and a MEMSCap(™) Medication Event Monitoring System (MEMSCap Inc., Durham, NC, USA) substudy (median cap openings per week: SCT group, n = 5; CT group, n

  16. An ex vivo, assessor blind, randomised, parallel group, comparative efficacy trial of the ovicidal activity of three pediculicides after a single application - melaleuca oil and lavender oil, eucalyptus oil and lemon tea tree oil, and a "suffocation" pediculicide

    Directory of Open Access Journals (Sweden)

    Altman Phillip M

    2011-08-01

    Full Text Available Abstract Background There are two components to the clinical efficacy of pediculicides: (i efficacy against the crawling-stages (lousicidal efficacy; and (ii efficacy against the eggs (ovicidal efficacy. Lousicidal efficacy and ovicidal efficacy are confounded in clinical trials. Here we report on a trial that was specially designed to rank the clinical ovicidal efficacy of pediculicides. Eggs were collected, pre-treatment and post-treatment, from subjects with different types of hair, different coloured hair and hair of different length. Method Subjects with at least 20 live eggs of Pediculus capitis (head lice were randomised to one of three treatment-groups: a melaleuca oil (commonly called tea tree oil and lavender oil pediculicide (TTO/LO; a eucalyptus oil and lemon tea tree oil pediculicide (EO/LTTO; or a "suffocation" pediculicide. Pre-treatment: 10 to 22 live eggs were taken from the head by cutting the single hair with the live egg attached, before the treatment (total of 1,062 eggs. Treatment: The subjects then received a single treatment of one of the three pediculicides, according to the manufacturers' instructions. Post-treatment: 10 to 41 treated live eggs were taken from the head by cutting the single hair with the egg attached (total of 1,183 eggs. Eggs were incubated for 14 days. The proportion of eggs that had hatched after 14 days in the pre-treatment group was compared with the proportion of eggs that hatched in the post-treatment group. The primary outcome measure was % ovicidal efficacy for each of the three pediculicides. Results 722 subjects were examined for the presence of eggs of head lice. 92 of these subjects were recruited and randomly assigned to: the "suffocation" pediculicide (n = 31; the melaleuca oil and lavender oil pediculicide (n = 31; and the eucalyptus oil and lemon tea tree oil pediculicide (n = 30 subjects. The group treated with eucalyptus oil and lemon tea tree oil had an ovicidal efficacy of 3.3% (SD

  17. Positive imagery cognitive bias modification (CBM) and internet-based cognitive behavioural therapy (iCBT) versus control CBM and iCBT for depression: study protocol for a parallel-group randomised controlled trial.

    Science.gov (United States)

    Williams, Alishia D; Blackwell, Simon E; Holmes, Emily A; Andrews, Gavin

    2013-10-29

    The current randomised controlled trial will evaluate the efficacy of an internet-delivered positive imagery cognitive bias modification (CBM) intervention for depression when compared with an active control condition and help establish the additive benefit of positive imagery CBM when delivered in combination with internet cognitive behavioural therapy for depression. Patients meeting diagnostic criteria for a current major depressive episode will be recruited through the research arm of a not-for-profit clinical and research unit in Australia. The minimum sample size for each group (α set at 0.05, power at 0.80) was identified as 29, but at least 10% more will be recruited to hedge against expected attrition. We will measure the impact of CBM on primary measures of depressive symptoms (Beck Depression Inventory-second edition (BDI-II), Patient Health Questionnaire (PHQ9)) and interpretive bias (ambiguous scenarios test-depression), and on a secondary measure of psychological distress (Kessler-10 (K10)) following the 1-week CBM intervention. Secondary outcome measures of psychological distress (K10), as well as disability (WHO disability assessment schedule-II), repetitive negative thinking (repetitive thinking questionnaire), and anxiety (state trait anxiety inventory-trait version) will be evaluated following completion of the 11-week combined intervention, in addition to the BDI-II and PHQ9. Intent-to-treat marginal and mixed effect models using restricted maximum likelihood estimation will be used to evaluate the primary hypotheses. Clinically significant change will be defined as high-end state functioning (a BDI-II score reduction greater than the reliable change index score. Maintenance of gains will be assessed at 3-month follow-up. The current trial protocol has been approved by the Human Research Ethics Committee of St Vincent's Hospital and the University of New South Wales, Sydney. Australian New Zealand Clinical Trials Registry: ACTRN12613000139774

  18. Group sequential designs for stepped-wedge cluster randomised trials.

    Science.gov (United States)

    Grayling, Michael J; Wason, James Ms; Mander, Adrian P

    2017-10-01

    The stepped-wedge cluster randomised trial design has received substantial attention in recent years. Although various extensions to the original design have been proposed, no guidance is available on the design of stepped-wedge cluster randomised trials with interim analyses. In an individually randomised trial setting, group sequential methods can provide notable efficiency gains and ethical benefits. We address this by discussing how established group sequential methodology can be adapted for stepped-wedge designs. Utilising the error spending approach to group sequential trial design, we detail the assumptions required for the determination of stepped-wedge cluster randomised trials with interim analyses. We consider early stopping for efficacy, futility, or efficacy and futility. We describe first how this can be done for any specified linear mixed model for data analysis. We then focus on one particular commonly utilised model and, using a recently completed stepped-wedge cluster randomised trial, compare the performance of several designs with interim analyses to the classical stepped-wedge design. Finally, the performance of a quantile substitution procedure for dealing with the case of unknown variance is explored. We demonstrate that the incorporation of early stopping in stepped-wedge cluster randomised trial designs could reduce the expected sample size under the null and alternative hypotheses by up to 31% and 22%, respectively, with no cost to the trial's type-I and type-II error rates. The use of restricted error maximum likelihood estimation was found to be more important than quantile substitution for controlling the type-I error rate. The addition of interim analyses into stepped-wedge cluster randomised trials could help guard against time-consuming trials conducted on poor performing treatments and also help expedite the implementation of efficacious treatments. In future, trialists should consider incorporating early stopping of some kind into

  19. Comparison in myelography between iodixanol 270 and 320 mgI/ml and iotrolan 300 mgI/ml: a multicentre, randomised, parallel-group, double-blind, phase III trial

    International Nuclear Information System (INIS)

    Palmers, Yvan; Kuhn, Fritz-Peter; Petersen, Dirk; De Greef, Danielle

    2002-01-01

    The objective of the trial was to compare the safety and efficacy of the non-ionic, dimeric, isotonic contrast medium iodixanol (Visipaque 270 and 320 mgI/ml) with those of iotrolan (Isovist 300 mgI/ml) in myelography. After lumbar or cervical puncture, 315 patients were examined in a multicentre, double-blind, randomised, comparative myelography study. Image quality, changes in vital signs, immediate and delayed adverse events were registered. There was a tendency for better images with iodixanol 320 than with iodixanol 270 and iotrolan 300, but the overall quality was good or excellent with all products. The frequency of patients reporting adverse events and headache varied much across centres, but there was no statistically significant difference between the contrast media. The incidence of events was higher after lumbar puncture than after cervical puncture, in women rather than in men, and after puncture with a 22-gauge (G) bevel-tipped needle compared with a 24 G Sprotte needle. The frequency of headache did not correlate with the absence of pathology. The higher iodine concentration in iodixanol 320 could be an advantage for film quality. When compared with iotrolan 300, iodixanol 320 and 270 give similar incidences of adverse events, including headache. (orig.)

  20. Parallel and Serial Grouping of Image Elements in Visual Perception

    Science.gov (United States)

    Houtkamp, Roos; Roelfsema, Pieter R.

    2010-01-01

    The visual system groups image elements that belong to an object and segregates them from other objects and the background. Important cues for this grouping process are the Gestalt criteria, and most theories propose that these are applied in parallel across the visual scene. Here, we find that Gestalt grouping can indeed occur in parallel in some…

  1. Platelet rich Plasma in Achilles Tendon Healing 2 (PATH-2) trial: protocol for a multicentre, participant and assessor-blinded, parallel-group randomised clinical trial comparing platelet-rich plasma (PRP) injection versus placebo injection for Achilles tendon rupture.

    Science.gov (United States)

    Alsousou, Joseph; Keene, David J; Hulley, Philippa A; Harrison, Paul; Wagland, Susan; Byrne, Christopher; Schlüssel, Michael Maia; Dutton, Susan J; Lamb, Sarah E; Willett, Keith

    2017-11-16

    Achilles tendon injuries give rise to substantial long-lasting morbidity and pose considerable challenges for clinicians and patients during the lengthy healing period. Current treatment strategies struggle to curb the burden of this injury on health systems and society due to lengthy rehabilitation, work absence and reinjury risk. Platelet-rich plasma (PRP) is an autologous preparation that has been shown to improve the mechanobiological properties of tendons in laboratory and animal studies. The use of PRP in musculoskeletal injuries is on the increase despite the lack of adequately powered clinical studies. This is a multicentre randomised controlled trial to evaluate the efficacy and mechanism of PRP in patients with acute Achilles tendon rupture (ATR). All adults with acute ATR presenting within 12 days of the injury who are to be treated non-operatively are eligible. A total of 230 consenting patients will be randomly allocated via a remote web-based service to receive PRP injection or placebo injection to the site of the injury. All participants will be blinded to the intervention and will receive standardised rehabilitation to reduce efficacy interference.Participants will be followed up with blinded assessments of muscle-tendon function, quality of life, pain and overall patient's functional goals at 4, 7, 13, 24 weeks and 24 months post-treatment. The primary outcome is the heel-rise endurance test (HRET), which will be supervised by a blinded assessor at 24 weeks. A subgroup of 16 participants in one centre will have needle biopsy under ultrasound guidance at 6 weeks. Blood and PRP will be analysed for cell count, platelet activation and growth factor concentrations. The protocol has been approved by the Oxfordshire Research Ethics Committee (Oxfordshire Research Ethics Committee A, reference no 14/SC/1333). The trial will be reported in accordance with the CONSORT statement and published in peer-reviewed scientific journals. ISRCTN: 54992179, assigned

  2. A Healthy School Start Plus for prevention of childhood overweight and obesity in disadvantaged areas through parental support in the school setting - study protocol for a parallel group cluster randomised trial.

    Science.gov (United States)

    Elinder, Liselotte Schäfer; Patterson, Emma; Nyberg, Gisela; Norman, Åsa

    2018-04-06

    Systematic reviews conclude that interventions to prevent overweight and obesity in children obtain stronger effects when parents are involved. Parenting practices and parent-child interactions shape children's health-related behaviours. The Healthy School Start Plus intervention aims to promote healthy dietary habits and physical activity and prevent obesity in children through parental support in disadvantaged areas with increased health needs, delivered by teachers and school nurses. This protocol describes the design, outcome and process evaluation of the study. Effectiveness of the intervention is compared to standard care within school health services. The 6-month programme, based on Social Cognitive Theory, consists of four components: 1) Health information to parents regarding the child; 2) Motivational Interviewing with the parents by the school nurse concerning the child; 3) classroom activities for the children by teachers; and 4) a web-based self-test of type-2 diabetes risk by parents. Effects will be studied in a cluster randomised trial including 17 schools and 352 six-year old children. The primary outcome is dietary intake of indicator foods, and secondary outcomes are physical activity, sedentary behaviour and BMI. Outcomes will be measured at baseline, at 6 months directly after the intervention, and at follow-up 18 months post baseline. Statistical analysis will be by mixed-effect regression analysis according to intention to treat and per protocol. Mediation analysis will be performed with parental self-efficacy and parenting practices. Quantitative and qualitative methods will be used to study implementation in terms of dose, fidelity, feasibility and acceptability. The hypothesis is that the programme will be more effective than standard care and feasible to perform in the school context. The programme is in line with the cumulated evidence regarding the prevention of childhood obesity: That schools should be a focal point of prevention

  3. Suitability Of Nitisinone In Alkaptonuria 1 (SONIA 1): an international, multicentre, randomised, open-label, no-treatment controlled, parallel-group, dose-response study to investigate the effect of once daily nitisinone on 24-h urinary homogentisic acid excretion in patients with alkaptonuria after 4 weeks of treatment.

    Science.gov (United States)

    Ranganath, Lakshminarayan R; Milan, Anna M; Hughes, Andrew T; Dutton, John J; Fitzgerald, Richard; Briggs, Michael C; Bygott, Helen; Psarelli, Eftychia E; Cox, Trevor F; Gallagher, James A; Jarvis, Jonathan C; van Kan, Christa; Hall, Anthony K; Laan, Dinny; Olsson, Birgitta; Szamosi, Johan; Rudebeck, Mattias; Kullenberg, Torbjörn; Cronlund, Arvid; Svensson, Lennart; Junestrand, Carin; Ayoob, Hana; Timmis, Oliver G; Sireau, Nicolas; Le Quan Sang, Kim-Hanh; Genovese, Federica; Braconi, Daniela; Santucci, Annalisa; Nemethova, Martina; Zatkova, Andrea; McCaffrey, Judith; Christensen, Peter; Ross, Gordon; Imrich, Richard; Rovensky, Jozef

    2016-02-01

    Alkaptonuria (AKU) is a serious genetic disease characterised by premature spondyloarthropathy. Homogentisate-lowering therapy is being investigated for AKU. Nitisinone decreases homogentisic acid (HGA) in AKU but the dose-response relationship has not been previously studied. Suitability Of Nitisinone In Alkaptonuria 1 (SONIA 1) was an international, multicentre, randomised, open-label, no-treatment controlled, parallel-group, dose-response study. The primary objective was to investigate the effect of different doses of nitisinone once daily on 24-h urinary HGA excretion (u-HGA24) in patients with AKU after 4 weeks of treatment. Forty patients were randomised into five groups of eight patients each, with groups receiving no treatment or 1 mg, 2 mg, 4 mg and 8 mg of nitisinone. A clear dose-response relationship was observed between nitisinone and the urinary excretion of HGA. At 4 weeks, the adjusted geometric mean u-HGA24 was 31.53 mmol, 3.26 mmol, 1.44 mmol, 0.57 mmol and 0.15 mmol for the no treatment or 1 mg, 2 mg, 4 mg and 8 mg doses, respectively. For the most efficacious dose, 8 mg daily, this corresponds to a mean reduction of u-HGA24 of 98.8% compared with baseline. An increase in tyrosine levels was seen at all doses but the dose-response relationship was less clear than the effect on HGA. Despite tyrosinaemia, there were no safety concerns and no serious adverse events were reported over the 4 weeks of nitisinone therapy. In this study in patients with AKU, nitisinone therapy decreased urinary HGA excretion to low levels in a dose-dependent manner and was well tolerated within the studied dose range. EudraCT number: 2012-005340-24. Registered at ClinicalTrials.gov: NCTO1828463. 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/

  4. Efficacy and safety of the partial PPARγ agonist balaglitazone compared with pioglitazone and placebo: A phase III, randomised, parallel-group study in patients with type 2 diabetes on stable insulin therapy

    DEFF Research Database (Denmark)

    Henriksen, Kim; Byrjalsen, Inger; Qvist, Per

    2011-01-01

    Treatment of patients with full PPARγ agonists is associated with weight gain, heart failure, peripheral oedema and bone loss. However, the safety of partial PPARγ agonists has not been established in a clinical trial. The BALLET trial aimed to establish the glucose-lowering effects and safety...... in all treatment arms. DXA analyses showed balaglitazone 10mg led to less fat and fluid accumulation and no change in bone mineral density, when compared to pioglitazone. In the balaglitazone 10mg treated group clinically relevant reductions in HbA(1c) and glucose levels were observed, although...... it appeared to be a little less potent that pioglitazone 45mg. On the other hand significantly less fluid and fat accumulation were observed, highlighting this treatment regimen for further studies....

  5. Study Protocol: The Norfolk Diabetes Prevention Study [NDPS]: a 46 month multi - centre, randomised, controlled parallel group trial of a lifestyle intervention [with or without additional support from lay lifestyle mentors with Type 2 diabetes] to prevent transition to Type 2 diabetes in high risk groups with non - diabetic hyperglycaemia, or impaired fasting glucose.

    Science.gov (United States)

    Pascale, Melanie; Murray, Nikki; Bachmann, Max; Barton, Garry; Clark, Allan; Howe, Amanda; Greaves, Colin; Sampson, Mike

    2017-01-06

    This 7 year NIHR programme [2011-2018] tests the primary hypothesis that the NDPS diet and physical activity intervention will reduce the risk of transition to type 2 diabetes (T2DM) in groups at high risk of Type 2 diabetes. The NDPS programme recognizes the need to reduce intervention costs through group delivery and the use of lay mentors with T2DM, the realities of normal primary care, and the complexity of the current glycaemic categorisation of T2DM risk. NDPS identifies people at highest risk of T2DM on the databases of 135 general practices in the East of England for further screening with ab fasting plasma glucose and glycosylated haemoglobin [HbA1c]. Those with an elevated fasting plasma glucose [impaired fasting glucose or IFG] with or without an elevated HbA1c [non -diabetic hyperglycaemia; NDH] are randomised into three treatment arms: a control arm receiving no trial intervention, an arm receiving an intensive bespoke group-based diet and physical activity intervention, and an arm receiving the same intervention with enhanced support from people with T2DM trained as diabetes prevention mentors [DPM]. The primary end point is cumulative transition rates to T2DM between the two intervention groups, and between each intervention group and the control group at 46 months. Participants with screen detected T2DM are randomized into an equivalent prospective controlled trial with the same intervention and control arms with glycaemic control [HbA1c] at 46 months as the primary end point. Participants with NDH and a normal fasting plasma glucose are randomised into an equivalent prospective controlled intervention trial with follow up for 40 months. The intervention comprises six education sessions for the first 12 weeks and then up to 15 maintenance sessions until intervention end, all delivered in groups, with additional support from a DPM in one treatment arm. The NDPS programme reports in 2018 and will provide trial outcome data for a group delivered

  6. Parallel and serial grouping of image elements in visual perception

    NARCIS (Netherlands)

    Houtkamp, R.; Roelfsema, P.R.

    2010-01-01

    The visual system groups image elements that belong to an object and segregates them from other objects and the background. Important cues for this grouping process are the Gestalt criteria, and most theories propose that these are applied in parallel across the visual scene. Here, we find that

  7. Prediabetes in pregnancy, can early intervention improve outcomes? A feasibility study for a parallel randomised clinical trial.

    Science.gov (United States)

    Hughes, Ruth C E; Rowan, Janet; Williman, Jonathan

    2018-03-03

    Measurement of glycated haemoglobin (HbA1c) in early pregnancy is routine in New Zealand to identify women with diabetes and prediabetes. However, the benefit of early intervention in women with prediabetes is inconclusive. Our aim was to test the feasibility of a two-arm parallel randomised controlled trial of standard care versus early intervention in pregnancies complicated by prediabetes. Two tertiary referral centres in New Zealand. Women measured at booking, without pre-existing diabetes. Randomisation was done by remote web-based allocation into one of two groups. Women in the early intervention group attended an antenatal diabetes clinic, commenced daily home blood glucose monitoring, and medication was prescribed if lifestyle measures failed to maintain target blood glucose levels. Controls received lifestyle education, continued standard care with their midwife and/or obstetrician, and were asked to perform a 75 g oral glucose tolerance test at 24 weeks' gestation with a referral to clinic if this test was positive. Both groups received lifestyle questionnaires at recruitment and in late pregnancy. Recruitment rate, adherence to protocol and validation of potential primary outcomes. Recruitment rates were lower than expected, especially in Māori and Pacific women. Non-adherence to allocated treatment protocol was significant, 42% (95% CI 24% to 61%) in the early intervention group and 30% (95% CI 16% to 51%) in controls. Caesarean section and pre-eclampsia were signalled as potential primary outcomes, due to both the high observed incidence in the control group and ease of measurement. For a future definitive trial, extending the gestation of eligibility and stepped-wedge cluster randomisation may overcome the identified feasibility issues. Consistent with published observational data, pre-eclampsia and emergency caesarean section could be included as primary outcome measures, both of which have a significant impact on maternal and neonatal morbidity and

  8. Establishing a group of endpoints in a parallel computer

    Science.gov (United States)

    Archer, Charles J.; Blocksome, Michael A.; Ratterman, Joseph D.; Smith, Brian E.; Xue, Hanhong

    2016-02-02

    A parallel computer executes a number of tasks, each task includes a number of endpoints and the endpoints are configured to support collective operations. In such a parallel computer, establishing a group of endpoints receiving a user specification of a set of endpoints included in a global collection of endpoints, where the user specification defines the set in accordance with a predefined virtual representation of the endpoints, the predefined virtual representation is a data structure setting forth an organization of tasks and endpoints included in the global collection of endpoints and the user specification defines the set of endpoints without a user specification of a particular endpoint; and defining a group of endpoints in dependence upon the predefined virtual representation of the endpoints and the user specification.

  9. Pragmatic randomised controlled trial of group psychoeducation versus group support in the maintenance of bipolar disorder

    Directory of Open Access Journals (Sweden)

    Roberts Christopher

    2011-07-01

    Full Text Available Abstract Background Non-didactically delivered curriculum based group psychoeducation has been shown to be more effective than both group support in a specialist mood disorder centre in Spain (with effects lasting up to five years, and treatment as usual in Australia. It is unclear whether the specific content and form of group psychoeducation is effective or the chance to meet and work collaboratively with other peers. The main objective of this trial is to determine whether curriculum based group psychoeducation is more clinically and cost effective than unstructured peer group support. Methods/design Single blind two centre cluster randomised controlled trial of 21 sessions group psychoeducation versus 21 sessions group peer support in adults with bipolar 1 or 2 disorder, not in current episode but relapsed in the previous two years. Individual randomisation is to either group at each site. The groups are carefully matched for the number and type of therapists, length and frequency of the interventions and overall aim of the groups but differ in content and style of delivery. The primary outcome is time to next bipolar episode with measures of the therapeutic process, barriers and drivers to the effective delivery of the interventions and economic analysis. Follow up is for 96 weeks after randomisation. Discussion The trial has features of both an efficacy and an effectiveness trial design. For generalisability in England it is set in routine public mental health practice with a high degree of expert patient involvement. Trial Registration ISRCTN62761948 Funding National Institute for Health Research, England.

  10. '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

  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. Parallel solutions of the two-group neutron diffusion equations

    International Nuclear Information System (INIS)

    Zee, K.S.; Turinsky, P.J.

    1987-01-01

    Recent efforts to adapt various numerical solution algorithms to parallel computer architectures have addressed the possibility of substantially reducing the running time of few-group neutron diffusion calculations. The authors have developed an efficient iterative parallel algorithm and an associated computer code for the rapid solution of the finite difference method representation of the two-group neutron diffusion equations on the CRAY X/MP-48 supercomputer having multi-CPUs and vector pipelines. For realistic simulation of light water reactor cores, the code employees a macroscopic depletion model with trace capability for selected fission product transients and critical boron. In addition to this, moderator and fuel temperature feedback models are also incorporated into the code. The validity of the physics models used in the code were benchmarked against qualified codes and proved accurate. This work is an extension of previous work in that various feedback effects are accounted for in the system; the entire code is structured to accommodate extensive vectorization; and an additional parallelism by multitasking is achieved not only for the solution of the matrix equations associated with the inner iterations but also for the other segments of the code, e.g., outer iterations

  13. Stepped-wedge cluster randomised controlled trials: a generic framework including parallel and multiple-level designs.

    Science.gov (United States)

    Hemming, Karla; Lilford, Richard; Girling, Alan J

    2015-01-30

    Stepped-wedge cluster randomised trials (SW-CRTs) are being used with increasing frequency in health service evaluation. Conventionally, these studies are cross-sectional in design with equally spaced steps, with an equal number of clusters randomised at each step and data collected at each and every step. Here we introduce several variations on this design and consider implications for power. One modification we consider is the incomplete cross-sectional SW-CRT, where the number of clusters varies at each step or where at some steps, for example, implementation or transition periods, data are not collected. We show that the parallel CRT with staggered but balanced randomisation can be considered a special case of the incomplete SW-CRT. As too can the parallel CRT with baseline measures. And we extend these designs to allow for multiple layers of clustering, for example, wards within a hospital. Building on results for complete designs, power and detectable difference are derived using a Wald test and obtaining the variance-covariance matrix of the treatment effect assuming a generalised linear mixed model. These variations are illustrated by several real examples. We recommend that whilst the impact of transition periods on power is likely to be small, where they are a feature of the design they should be incorporated. We also show examples in which the power of a SW-CRT increases as the intra-cluster correlation (ICC) increases and demonstrate that the impact of the ICC is likely to be smaller in a SW-CRT compared with a parallel CRT, especially where there are multiple levels of clustering. Finally, through this unified framework, the efficiency of the SW-CRT and the parallel CRT can be compared. © 2014 The Authors. Statistics in Medicine Published by John Wiley & Sons Ltd.

  14. Group hypnosis vs. relaxation for smoking cessation in adults: a cluster-randomised controlled trial

    Science.gov (United States)

    2013-01-01

    Background Despite the popularity of hypnotherapy for smoking cessation, the efficacy of this method is unclear. We aimed to investigate the efficacy of a single-session of group hypnotherapy for smoking cessation compared to relaxation in Swiss adult smokers. Methods This was a cluster-randomised, parallel-group, controlled trial. A single session of hypnosis or relaxation for smoking cessation was delivered to groups of smokers (median size = 11). Participants were 223 smokers consuming ≥ 5 cigarettes per day, willing to quit and not using cessation aids (47.1% females, M = 37.5 years [SD = 11.8], 86.1% Swiss). Nicotine withdrawal, smoking abstinence self-efficacy, and adverse reactions were assessed at a 2-week follow-up. The main outcome, self-reported 30-day point prevalence of smoking abstinence, was assessed at a 6-month follow up. Abstinence was validated through salivary analysis. Secondary outcomes included number of cigarettes smoked per day, smoking abstinence self-efficacy, and nicotine withdrawal. Results At the 6-month follow up, 14.7% in the hypnosis group and 17.8% in the relaxation group were abstinent. The intervention had no effect on smoking status (p = .73) or on the number of cigarettes smoked per day (p = .56). Smoking abstinence self-efficacy did not differ between the interventions (p = .14) at the 2-week follow-up, but non-smokers in the hypnosis group experienced reduced withdrawal (p = .02). Both interventions produced few adverse reactions (p = .81). Conclusions A single session of group hypnotherapy does not appear to be more effective for smoking cessation than a group relaxation session. Trial registration Current Controlled Trials ISRCTN72839675. PMID:24365274

  15. Group hypnosis vs. relaxation for smoking cessation in adults: a cluster-randomised controlled trial.

    Science.gov (United States)

    Dickson-Spillmann, Maria; Haug, Severin; Schaub, Michael P

    2013-12-23

    Despite the popularity of hypnotherapy for smoking cessation, the efficacy of this method is unclear. We aimed to investigate the efficacy of a single-session of group hypnotherapy for smoking cessation compared to relaxation in Swiss adult smokers. This was a cluster-randomised, parallel-group, controlled trial. A single session of hypnosis or relaxation for smoking cessation was delivered to groups of smokers (median size = 11). Participants were 223 smokers consuming ≥ 5 cigarettes per day, willing to quit and not using cessation aids (47.1% females, M = 37.5 years [SD = 11.8], 86.1% Swiss). Nicotine withdrawal, smoking abstinence self-efficacy, and adverse reactions were assessed at a 2-week follow-up. The main outcome, self-reported 30-day point prevalence of smoking abstinence, was assessed at a 6-month follow up. Abstinence was validated through salivary analysis. Secondary outcomes included number of cigarettes smoked per day, smoking abstinence self-efficacy, and nicotine withdrawal. At the 6-month follow up, 14.7% in the hypnosis group and 17.8% in the relaxation group were abstinent. The intervention had no effect on smoking status (p = .73) or on the number of cigarettes smoked per day (p = .56). Smoking abstinence self-efficacy did not differ between the interventions (p = .14) at the 2-week follow-up, but non-smokers in the hypnosis group experienced reduced withdrawal (p = .02). Both interventions produced few adverse reactions (p = .81). A single session of group hypnotherapy does not appear to be more effective for smoking cessation than a group relaxation session. Current Controlled Trials ISRCTN72839675.

  16. A randomised, double blind, placebo-controlled, multi-centric parallel arm trial to assess the effects of homoeopathic medicines on chronic rhinosinusitis

    Directory of Open Access Journals (Sweden)

    Raj K Manchanda

    2014-01-01

    Full Text Available Background: Chronic rhinosinusitis (CRS is one of the most common illnesses interfering with patient′s quality of life and work. Observational studies conducted by the Council indicate positive outcome. This protocol has been developed to ascertain the usefulness of homoeopathic intervention in comparison with control group in a randomised control setting. Objectives: Primary objective is to evaluate the changes in TSS (Total Symptoms Score and SNOT-22 (Sino-nasal Outcome Test-22 within the two groups of the study (Homoeopathy + Placebo. Secondary objective is to evaluate changes in SNOT-22 at end of the trial, changes in Lund and Mackay staging of CT scan, rhinoscopy grading, absolute eosinophil count, global assessment by investigator and patient, and number of acute exacerbations of CRS (for frequency, duration and intensity as per TSS scale compared to placebo. Methods/Design: This is a randomised double blind, placebo-controlled, multi-centric parallel arm trial of 6 months (three months treatment and three months observation period with 14 days run-in period. The primary outcome is a composite of the changes in the TSS and SNOT-22 over 3 months from baseline with area under the curve and changes over 3 months in the Sinus Nasal Outcome Test 22 (SNOT-22 from baseline. Prescription shall be made as per the homoeopathic principles. Efficacy data will be analysed in the intention-to-treat population. Discussion: This trial will help to evaluate the efficacy of homoeopathic individualised treatment using LM-potencies versus placebo in patients suffering from CRS as per the homoeopathic dictum.

  17. Massively parallel read mapping on GPUs with the q-group index and PEANUT

    NARCIS (Netherlands)

    J. Köster (Johannes); S. Rahmann (Sven)

    2014-01-01

    textabstractWe present the q-group index, a novel data structure for read mapping tailored towards graphics processing units (GPUs) with a small memory footprint and efficient parallel algorithms for querying and building. On top of the q-group index we introduce PEANUT, a highly parallel GPU-based

  18. Communication partner training for health care professionals in an inpatient rehabilitation setting: A parallel randomised trial.

    Science.gov (United States)

    Heard, Renee; O'Halloran, Robyn; McKinley, Kathryn

    2017-06-01

    The purpose of this study is to determine if the E-Learning Plus communication partner training (CPT) programme is as effective as the Supported Conversation for Adults with Aphasia (SCA TM ) CPT programme in improving healthcare professionals' confidence and knowledge communicating with patients with aphasia. Forty-eight healthcare professionals working in inpatient rehabilitation participated. Participants were randomised to one of the CPT programmes. The three outcome measures were self-rating of confidence, self-rating of knowledge and a test of knowledge of aphasia. Measures were taken pre-, immediately post- and 3-4 months post-training. Data were analysed using mixed between within ANOVAs. Homogeneity of variance was adequate for self-rating of confidence and test of knowledge of aphasia data to continue analysis. There was a statistically significant difference in self-rating of confidence and knowledge of aphasia for both interventions across time. No statistically significant difference was found between the two interventions. Both CPT interventions were associated with an increase in health care professionals' confidence and knowledge of aphasia, but neither programme was superior. As the E-Learning Plus CPT programme is more accessible and sustainable in the Australian healthcare context, further work will continue on this CPT programme.

  19. Task shifting of antiretroviral treatment from doctors to primary-care nurses in South Africa (STRETCH): a pragmatic, parallel, cluster-randomised trial.

    Science.gov (United States)

    Fairall, Lara; Bachmann, Max O; Lombard, Carl; Timmerman, Venessa; Uebel, Kerry; Zwarenstein, Merrick; Boulle, Andrew; Georgeu, Daniella; Colvin, Christopher J; Lewin, Simon; Faris, Gill; Cornick, Ruth; Draper, Beverly; Tshabalala, Mvula; Kotze, Eduan; van Vuuren, Cloete; Steyn, Dewald; Chapman, Ronald; Bateman, Eric

    2012-09-08

    Robust evidence of the effectiveness of task shifting of antiretroviral therapy (ART) from doctors to other health workers is scarce. We aimed to assess the effects on mortality, viral suppression, and other health outcomes and quality indicators of the Streamlining Tasks and Roles to Expand Treatment and Care for HIV (STRETCH) programme, which provides educational outreach training of nurses to initiate and represcribe ART, and to decentralise care. We undertook a pragmatic, parallel, cluster-randomised trial in South Africa between Jan 28, 2008, and June 30, 2010. We randomly assigned 31 primary-care ART clinics to implement the STRETCH programme (intervention group) or to continue with standard care (control group). The ratio of randomisation depended on how many clinics were in each of nine strata. Two cohorts were enrolled: eligible patients in cohort 1 were adults (aged ≥16 years) with CD4 counts of 350 cells per μL or less who were not receiving ART; those in cohort 2 were adults who had already received ART for at least 6 months and were being treated at enrolment. The primary outcome in cohort 1 was time to death (superiority analysis). The primary outcome in cohort 2 was the proportion with undetectable viral loads (baseline CD4 counts of 201-350 cells per μL, mortality was slightly lower in the intervention group than in the control group (0·73, 0·54-1.00; p=0·052), but it did not differ between groups in patients with baseline CD4 of 200 cells per μL or less (0·94, 0·76-1·15; p=0·577). In cohort 2, viral load suppression 12 months after enrolment was equivalent in intervention (2156 [71%] of 3029 patients) and control groups (2230 [70%] of 3202; risk difference 1·1%, 95% CI -2·4 to 4·6). Expansion of primary-care nurses' roles to include ART initiation and represcription can be done safely, and improve health outcomes and quality of care, but might not reduce time to ART or mortality. UK Medical Research Council, Development Cooperation

  20. Group cognitive behavioural therapy and weight regain after diet in type 2 diabetes: results from the randomised controlled POWER trial.

    Science.gov (United States)

    Berk, Kirsten A; Buijks, Hanneke I M; Verhoeven, Adrie J M; Mulder, Monique T; Özcan, Behiye; van 't Spijker, Adriaan; Timman, Reinier; Busschbach, Jan J; Sijbrands, Eric J

    2018-04-01

    Weight-loss programmes for adults with type 2 diabetes are less effective in the long term owing to regain of weight. Our aim was to determine the 2 year effectiveness of a cognitive behavioural group therapy (group-CBT) programme in weight maintenance after diet-induced weight loss in overweight and obese adults with type 2 diabetes, using a randomised, parallel, non-blinded, pragmatic study design. We included 158 obese adults (median BMI 36.3 [IQR 32.5-40.0] kg/m 2 ) with type 2 diabetes from the outpatient diabetes clinic of Erasmus MC, the Netherlands, who achieved ≥5% weight loss on an 8 week very low calorie diet. Participants were randomised (stratified by weight loss) to usual care or usual care plus group-CBT (17 group sessions). The primary outcomes were the between-group differences after 2 years in: (1) body weight; and (2) weight regain. Secondary outcomes were HbA 1c levels, insulin dose, plasma lipid levels, depression, anxiety, self-esteem, quality of life, fatigue, physical activity, eating disorders and related cognitions. Data were analysed using linear mixed modelling. During the initial 8 week dieting phase, the control group (n = 75) lost a mean of 10.0 (95% CI 9.1, 10.9) kg and the intervention group (n = 83) lost 9.2 (95% CI 8.4, 10.0) kg (p = 0.206 for the between-group difference). During 2 years of follow-up, mean weight regain was 4.7 (95% CI 3.0, 6.3) kg for the control group and 4.0 (95% CI 2.3, 5.6) kg for the intervention group, with a between-group difference of -0.7 (95% CI -3.1, 1.6) kg (p = 0.6). The mean difference in body weight at 2 years was -1.2 (95% CI -7.7, 5.3) kg (p = 0.7). None of the secondary outcomes differed between the two groups. Despite increased treatment contact, a group-CBT programme for long-term weight maintenance after an initial ≥5% weight loss from dieting in obese individuals with type 2 diabetes was not superior to usual care alone. Trialregister.nl NTR2264 FUNDING: The

  1. Protocol for a multicentre, parallel-arm, 12-month, randomised, controlled trial of arthroscopic surgery versus conservative care for femoroacetabular impingement syndrome (FASHIoN).

    Science.gov (United States)

    Griffin, D R; Dickenson, E J; Wall, P D H; Donovan, J L; Foster, N E; Hutchinson, C E; Parsons, N; Petrou, S; Realpe, A; Achten, J; Achana, F; Adams, A; Costa, M L; Griffin, J; Hobson, R; Smith, J

    2016-08-31

    Femoroacetabular impingement (FAI) syndrome is a recognised cause of young adult hip pain. There has been a large increase in the number of patients undergoing arthroscopic surgery for FAI; however, a recent Cochrane review highlighted that there are no randomised controlled trials (RCTs) evaluating treatment effectiveness. We aim to compare the clinical and cost-effectiveness of arthroscopic surgery versus best conservative care for patients with FAI syndrome. We will conduct a multicentre, pragmatic, assessor-blinded, two parallel arm, RCT comparing arthroscopic surgery to physiotherapy-led best conservative care. 24 hospitals treating NHS patients will recruit 344 patients over a 26-month recruitment period. Symptomatic adults with radiographic signs of FAI morphology who are considered suitable for arthroscopic surgery by their surgeon will be eligible. Patients will be excluded if they have radiographic evidence of osteoarthritis, previous significant hip pathology or previous shape changing surgery. Participants will be allocated in a ratio of 1:1 to receive arthroscopic surgery or conservative care. Recruitment will be monitored and supported by qualitative intervention to optimise informed consent and recruitment. The primary outcome will be pain and function assessed by the international hip outcome tool 33 (iHOT-33) measured 1-year following randomisation. Secondary outcomes include general health (short form 12), quality of life (EQ5D-5L) and patient satisfaction. The primary analysis will compare change in pain and function (iHOT-33) at 12 months between the treatment groups, on an intention-to-treat basis, presented as the mean difference between the trial groups with 95% CIs. The study is funded by the Health Technology Assessment Programme (13/103/02). Ethical approval is granted by the Edgbaston Research Ethics committee (14/WM/0124). The results will be disseminated through open access peer-reviewed publications, including Health Technology

  2. The effect of motivational interviewing on glycaemic control and perceived competence of diabetes self-management in patients with type 1 and type 2 diabetes mellitus after attending a group education programme: a randomised controlled trial

    DEFF Research Database (Denmark)

    Rosenbek Minet, L K; Wagner, L; Lønvig, E M

    2011-01-01

    education programme, 349 patients were randomised to either a usual care control group or an intervention group, which received up to five individual counselling sessions in 1 year based on MI, in addition to usual care. A randomised parallel design was used and open-label allocation was done by random...... diabetes mellitus, were over 18 years of age and had participated in a 4 day group education programme offered at a diabetes clinic at a university hospital in Denmark. Exclusion criteria included pregnancy, severe debilitating disease and cognitive deficit. Out of 469 patients who attended the group...... diabetes self-care, compared with usual care. RESULTS: Out of the 176 included in the control group and 173 in the intervention group, 153 and 145 were analysed in the groups, respectively. When using the baseline value as covariate there were no significant differences in change score between the two...

  3. Psychodrama: A Creative Approach for Addressing Parallel Process in Group Supervision

    Science.gov (United States)

    Hinkle, Michelle Gimenez

    2008-01-01

    This article provides a model for using psychodrama to address issues of parallel process during group supervision. Information on how to utilize the specific concepts and techniques of psychodrama in relation to group supervision is discussed. A case vignette of the model is provided.

  4. 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 ...

  5. A double-blind, placebo-controlled, randomised, parallel-group, dose-escalating, repeat dose study in healthy volunteers to evaluate the safety, tolerability, pharmacodynamic effects and pharmacokinetics of the once daily rectal application of NRL001 suppositories for 14 days.

    Science.gov (United States)

    Bell, D; Duffin, A; Jacobs, A; Pediconi, C; Gruss, H J

    2014-03-01

    The 1R,2S stereoisomer of methoxamine hydrochloride, NRL001, is a highly selective α1-adrenoceptor agonist being developed for the local treatment of non-structural faecal incontinence caused by weak internal anal sphincter tone. This study investigated the steady state pharmacokinetics (PK) and safety of 2 g rectal suppositories containing NRL001 in different strengths (7.5, 10, 12.5 or 15 mg). Healthy volunteers aged 18-45 years received 14 daily doses of NRL001 2 g suppositories or matching placebo. In each dose group nine participants received NRL001 and three received placebo. Blood samples to determine NRL001 concentrations were taken on Days 1, 7 and 14. Cardiovascular parameters were collected via electrocardiograms, Holter monitoring (three lead Holter monitor) and vital signs. Forty-eight volunteers were enrolled; 43 completed the study and were included in the PK analysis population. AUC and Cmax broadly increased with increasing dose, Tmax generally occurred between 4.0 and 5.0 h. Although the data did not appear strongly dose proportional, dose proportionality analysis did not provide evidence against dose proportionality as the log(dose) coefficients were not significantly < 1. NRL001 did not accumulate over time for any dose. Increasing NRL001 concentrations were related to changes in vital sign variables, most notably decreased heart rate. The most commonly reported adverse events (AEs) in the active treatment groups were paraesthesia and piloerection. Treatment with NRL001 was generally well tolerated over 14 days once daily dosing and plasma NRL001 did not accumulate over time. Treatment was associated with changes in vital sign variables, most notably decreased heart rate. AEs commonly reported with NRL001 treatment were events indicative of a systemic α-adrenergic effect. Colorectal Disease © 2014 The Association of Coloproctology of Great Britain and Ireland.

  6. Beyond Silence: A Randomized, Parallel-Group Trial Exploring the Impact of Workplace Mental Health Literacy Training with Healthcare Employees.

    Science.gov (United States)

    Moll, Sandra E; Patten, Scott; Stuart, Heather; MacDermid, Joy C; Kirsh, Bonnie

    2018-01-01

    This study sought to evaluate whether a contact-based workplace education program was more effective than standard mental health literacy training in promoting early intervention and support for healthcare employees with mental health issues. A parallel-group, randomised trial was conducted with employees in 2 multi-site Ontario hospitals with the evaluators blinded to the groups. Participants were randomly assigned to 1 of 2 group-based education programs: Beyond Silence (comprising 6 in-person, 2-h sessions plus 5 online sessions co-led by employees who personally experienced mental health issues) or Mental Health First Aid (a standardised 2-day training program led by a trained facilitator). Participants completed baseline, post-group, and 3-mo follow-up surveys to explore perceived changes in mental health knowledge, stigmatized beliefs, and help-seeking/help-outreach behaviours. An intent-to-treat analysis was completed with 192 participants. Differences were assessed using multi-level mixed models accounting for site, group, and repeated measurement. Neither program led to significant increases in help-seeking or help-outreach behaviours. Both programs increased mental health literacy, improved attitudes towards seeking treatment, and decreased stigmatized beliefs, with sustained changes in stigmatized beliefs more prominent in the Beyond Silence group. Beyond Silence, a new contact-based education program customised for healthcare workers was not superior to standard mental health literacy training in improving mental health help-seeking or help-outreach behaviours in the workplace. The only difference was a reduction in stigmatized beliefs over time. Additional research is needed to explore the factors that lead to behaviour change.

  7. A Phase IIIb, Multicentre, Randomised, Parallel-Group, Placebo-Controlled, Double-Blind Study to Investigate the Efficacy and Safety of OROS Hydromorphone in Subjects with Moderate-to-Severe Chronic Pain Induced by Osteoarthritis of the Hip or the Knee

    Directory of Open Access Journals (Sweden)

    Jozef Vojtaššák

    2011-01-01

    Full Text Available Background. Opioid analgesics are included in treatment guidelines for the symptomatic management of osteoarthritis (OA. Starting with a low dose of opioid and slowly titrating to a higher dose may help avoid intolerable side effects. Methods. Subjects aged ≥40 years, with moderate to severe pain induced by OA of the hip or knee not adequately controlled by previous non-steroidal anti-inflammatory drugs (NSAIDs or paracetamol treatment, were enrolled. Subjects received OROS hydromorphone 4 mg or placebo once-daily. The dose was titrated every 3-4 days in case of unsatisfactory pain control during the 4-week titration phase. A 12 week maintenance phase followed. The primary efficacy endpoint was the change in “pain on average” measured on the Brief Pain Inventory (BPI scale from baseline to the end of the maintenance phase. Results. 139 subjects received OROS hydromorphone and 149 subjects received placebo. All efficacy endpoints showed similar improvements from baseline to end of study in the 2 groups. The safety results were consistent with the safety profile of OROS hydromorphone. Conclusion.The study did not meet the primary endpoint; although many subjects' pain was not adequately controlled at inclusion, their pain may have improved with continued paracetamol or NSAID treatment.

  8. Reducing Delusional Conviction Through a Cognitive-Based Group Training Game: A Multicentre Randomised Controlled Trial

    Directory of Open Access Journals (Sweden)

    Yasser eKhazaal

    2015-04-01

    Full Text Available AbstractObjective: Michael’s Game is a card game targeting the ability to generate alternative hypotheses to explain a given experience. The main objective was to evaluate the effect of MG on delusional conviction as measured by the primary study outcome: the change in scores on the conviction subscale of the Peters Delusions Inventory (PDI-21. Other variables of interest were the change in scores on the distress and preoccupation subscales of the PDI-21, the Brief Psychiatric Rating Scale, the Beck Cognitive Insight Scale, and belief flexibility assessed with the Maudsley Assessment of Delusions Schedule. Methods: We performed a parallel, assessor-blinded, randomised controlled superiority trial comparing treatment as usual plus participation in Michael’s Game (MG with treatment as usual plus being on a waiting list (TAU in a sample of adult outpatients with psychotic disorders and persistent positive psychotic symptoms at inclusion. Results: The 172 participants were randomised, with 86 included in each study arm. Assessments were performed at inclusion (T1: baseline, at 3 months (T2: post-treatment, and at 6 months after the second assessment (T3: follow-up. At T2, a positive treatment effect was observed on the primary outcome, the PDI-21 conviction subscale (p=0.005. At T3, a sustained effect was observed for the conviction subscale (p=0.002. Further effects were also observed at T3 on the PDI-21 distress (p=0.002 and preoccupation subscales (p=0.001, as well as on one of the MADS measures of belief flexibility (anything against the belief (p=0.001. Conclusions: The study demonstrated some significant beneficial effect of MG. http://www.controlled-trials.com/ISRCTN37178153/Funding: Swiss National Science Foundation Grant 32003B-121038

  9. Study protocol: Brief intervention for medication overuse headache - A double-blinded cluster randomised parallel controlled trial in primary care

    Directory of Open Access Journals (Sweden)

    Kristoffersen Espen

    2012-08-01

    Full Text Available Abstract Background Chronic headache (headache ≥ 15 days/month for at least 3 months affects 2–5% of the general population. Medication overuse contributes to the problem. Medication-overuse headache (MOH can be identified by using the Severity of Dependence Scale (SDS. A “brief intervention” scheme (BI has previously been used for detoxification from drug and alcohol overuse in other settings. Short, unstructured, individualised simple information may also be enough to detoxify a large portion of those with MOH. We have adapted the structured (BI scheme to be used for MOH in primary care. Methods/Design A double-blinded cluster randomised parallel controlled trial (RCT of BI vs. business as usual. Intervention will be performed in primary care by GPs trained in BI. Patients with MOH will be identified through a simple screening questionnaire sent to patients on the GPs lists. The BI method involves an approach for identifying patients with high likelihood of MOH using simple questions about headache frequency and the SDS score. Feedback is given to the individual patient on his/her score and consequences this might have regarding the individual risk of medication overuse contributing to their headache. Finally, advice is given regarding measures to be taken, how the patient should proceed and the possible gains for the patient. The participating patients complete a headache diary and receive a clinical interview and neurological examination by a GP experienced in headache diagnostics three months after the intervention. Primary outcomes are number of headache days and number of medication days per month at 3 months. Secondary outcomes include proportions with 25 and 50% improvement at 3 months and maintenance of improvement and quality of life after 12 months. Discussion There is a need for evidence-based and cost-effective strategies for treatment of MOH but so far no consensus has been reached regarding an optimal medication

  10. Increasing physical activity among young children from disadvantaged communities: study protocol of a group randomised controlled effectiveness trial.

    Science.gov (United States)

    Stanley, Rebecca M; Jones, Rachel A; Cliff, Dylan P; Trost, Stewart G; Berthelsen, Donna; Salmon, Jo; Batterham, Marijka; Eckermann, Simon; Reilly, John J; Brown, Ngiare; Mickle, Karen J; Howard, Steven J; Hinkley, Trina; Janssen, Xanne; Chandler, Paul; Cross, Penny; Gowers, Fay; Okely, Anthony D

    2016-10-19

    Participation in regular physical activity (PA) during the early years helps children achieve healthy body weight and can substantially improve motor development, bone health, psychosocial health and cognitive development. Despite common assumptions that young children are naturally active, evidence shows that they are insufficiently active for health and developmental benefits. Exploring strategies to increase physical activity in young children is a public health and research priority. Jump Start is a multi-component, multi-setting PA and gross motor skill intervention for young children aged 3-5 years in disadvantaged areas of New South Wales, Australia. The intervention will be evaluated using a two-arm, parallel group, randomised cluster trial. The Jump Start protocol was based on Social Cognitive Theory and includes five components: a structured gross motor skill lesson (Jump In); unstructured outdoor PA and gross motor skill time (Jump Out); energy breaks (Jump Up); activities connecting movement to learning experiences (Jump Through); and a home-based family component to promote PA and gross motor skill (Jump Home). Early childhood education and care centres will be demographically matched and randomised to Jump Start (intervention) or usual practice (comparison) group. The intervention group receive Jump Start professional development, program resources, monthly newsletters and ongoing intervention support. Outcomes include change in total PA (accelerometers) within centre hours, gross motor skill development (Test of Gross Motor Development-2), weight status (body mass index), bone strength (Sunlight MiniOmni Ultrasound Bone Sonometer), self-regulation (Heads-Toes-Knees-Shoulders, executive function tasks, and proxy-report Temperament and Approaches to learning scales), and educator and parent self-efficacy. Extensive quantitative and qualitative process evaluation and a cost-effectiveness evaluation will be conducted. The Jump Start intervention is a

  11. Increasing physical activity among young children from disadvantaged communities: study protocol of a group randomised controlled effectiveness trial

    Directory of Open Access Journals (Sweden)

    Rebecca M. Stanley

    2016-10-01

    Full Text Available Abstract Background Participation in regular physical activity (PA during the early years helps children achieve healthy body weight and can substantially improve motor development, bone health, psychosocial health and cognitive development. Despite common assumptions that young children are naturally active, evidence shows that they are insufficiently active for health and developmental benefits. Exploring strategies to increase physical activity in young children is a public health and research priority. Methods Jump Start is a multi-component, multi-setting PA and gross motor skill intervention for young children aged 3–5 years in disadvantaged areas of New South Wales, Australia. The intervention will be evaluated using a two-arm, parallel group, randomised cluster trial. The Jump Start protocol was based on Social Cognitive Theory and includes five components: a structured gross motor skill lesson (Jump In; unstructured outdoor PA and gross motor skill time (Jump Out; energy breaks (Jump Up; activities connecting movement to learning experiences (Jump Through; and a home-based family component to promote PA and gross motor skill (Jump Home. Early childhood education and care centres will be demographically matched and randomised to Jump Start (intervention or usual practice (comparison group. The intervention group receive Jump Start professional development, program resources, monthly newsletters and ongoing intervention support. Outcomes include change in total PA (accelerometers within centre hours, gross motor skill development (Test of Gross Motor Development-2, weight status (body mass index, bone strength (Sunlight MiniOmni Ultrasound Bone Sonometer, self-regulation (Heads-Toes-Knees-Shoulders, executive function tasks, and proxy-report Temperament and Approaches to learning scales, and educator and parent self-efficacy. Extensive quantitative and qualitative process evaluation and a cost-effectiveness evaluation will be conducted

  12. Integration of balance and strength training into daily life activity to reduce rate of falls in older people (the LiFE study): randomised parallel trial.

    Science.gov (United States)

    Clemson, Lindy; Fiatarone Singh, Maria A; Bundy, Anita; Cumming, Robert G; Manollaras, Kate; O'Loughlin, Patricia; Black, Deborah

    2012-08-07

    To determine whether a lifestyle integrated approach to balance and strength training is effective in reducing the rate of falls in older, high risk people living at home. Three arm, randomised parallel trial; assessments at baseline and after six and 12 months. Randomisation done by computer generated random blocks, stratified by sex and fall history and concealed by an independent secure website. Residents in metropolitan Sydney, Australia. Participants aged 70 years or older who had two or more falls or one injurious fall in past 12 months, recruited from Veteran's Affairs databases and general practice databases. Exclusion criteria were moderate to severe cognitive problems, inability to ambulate independently, neurological conditions that severely influenced gait and mobility, resident in a nursing home or hostel, or any unstable or terminal illness that would affect ability to do exercises. Three home based interventions: Lifestyle integrated Functional Exercise (LiFE) approach (n=107; taught principles of balance and strength training and integrated selected activities into everyday routines), structured programme (n=105; exercises for balance and lower limb strength, done three times a week), sham control programme (n=105; gentle exercise). LiFE and structured groups received five sessions with two booster visits and two phone calls; controls received three home visits and six phone calls. Assessments made at baseline and after six and 12 months. Primary measure: rate of falls over 12 months, collected by self report. Secondary measures: static and dynamic balance; ankle, knee and hip strength; balance self efficacy; daily living activities; participation; habitual physical activity; quality of life; energy expenditure; body mass index; and fat free mass. After 12 months' follow-up, we recorded 172, 193, and 224 falls in the LiFE, structured exercise, and control groups, respectively. The overall incidence of falls in the LiFE programme was 1.66 per person

  13. CONSORT 2010 Explanation and Elaboration: Updated guidelines for reporting parallel group randomised trials

    DEFF Research Database (Denmark)

    Moher, David; Hopewell, Sally; Schulz, Kenneth F

    2010-01-01

    improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition, such as selective outcome reporting bias. This explanatory and elaboration document-intended to enhance the use, understanding, and dissemination...... of the CONSORT statement-has also been extensively revised. It presents the meaning and rationale for each new and updated checklist item providing examples of good reporting and, where possible, references to relevant empirical studies. Several examples of flow diagrams are included. The CONSORT 2010 Statement...

  14. 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

  15. Split-mouth and parallel-arm trials to compare pain with intraosseous anaesthesia delivered by the computerised Quicksleeper system and conventional infiltration anaesthesia in paediatric oral healthcare: protocol for a randomised controlled trial.

    Science.gov (United States)

    Smaïl-Faugeron, Violaine; Muller-Bolla, Michèle; Sixou, Jean-Louis; Courson, Frédéric

    2015-07-10

    Local anaesthesia is commonly used in paediatric oral healthcare. Infiltration anaesthesia is the most frequently used, but recent developments in anaesthesia techniques have introduced an alternative: intraosseous anaesthesia. We propose to perform a split-mouth and parallel-arm multicentre randomised controlled trial (RCT) comparing the pain caused by the insertion of the needle for the injection of conventional infiltration anaesthesia, and intraosseous anaesthesia by the computerised QuickSleeper system, in children and adolescents. Inclusion criteria are patients 7-15 years old with at least 2 first permanent molars belonging to the same dental arch (for the split-mouth RCT) or with a first permanent molar (for the parallel-arm RCT) requiring conservative or endodontic treatment limited to pulpotomy. The setting of this study is the Department of Paediatric Dentistry at 3 University dental hospitals in France. The primary outcome measure will be pain reported by the patient on a visual analogue scale concerning the insertion of the needle and the injection/infiltration. Secondary outcomes are latency, need for additional anaesthesia during the treatment and pain felt during the treatment. We will use a computer-generated permuted-block randomisation sequence for allocation to anaesthesia groups. The random sequences will be stratified by centre (and by dental arch for the parallel-arm RCT). Only participants will be blinded to group assignment. Data will be analysed by the intent-to-treat principle. In all, 160 patients will be included (30 in the split-mouth RCT, 130 in the parallel-arm RCT). This protocol has been approved by the French ethics committee for the protection of people (Comité de Protection des Personnes, Ile de France I) and will be conducted in full accordance with accepted ethical principles. Findings will be reported in scientific publications and at research conferences, and in project summary papers for participants. Clinical

  16. A Lightweight RFID Grouping-Proof Protocol Based on Parallel Mode and DHCP Mechanism

    Directory of Open Access Journals (Sweden)

    Zhicai Shi

    2017-07-01

    Full Text Available A Radio Frequency Identification (RFID grouping-proof protocol is to generate an evidence of the simultaneous existence of a group of tags and it has been applied to many different fields. For current grouping-proof protocols, there still exist some flaws such as low grouping-proof efficiency, being vulnerable to trace attack and information leakage. To improve the secure performance and efficiency, we propose a lightweight RFID grouping-proof protocol based on parallel mode and DHCP (Dynamic Host Configuration Protocol mechanism. Our protocol involves multiple readers and multiple tag groups. During the grouping-proof period, one reader and one tag group are chosen by the verifier by means of DHCP mechanism. When only a part of the tags of the chosen group exist, the protocol can also give the evidence of their co-existence. Our protocol utilizes parallel communication mode between reader and tags so as to ensure its grouping-proof efficiency. It only uses Hash function to complete the mutual authentication among verifier, readers and tags. It can preserve the privacy of the RFID system and resist the attacks such as eavesdropping, replay, trace and impersonation. Therefore the protocol is secure, flexible and efficient. It only uses some lightweight operations such as Hash function and a pseudorandom number generator. Therefore it is very suitable to some low-cost RFID systems.

  17. Parental presence on neonatal intensive care unit clinical bedside rounds: randomised trial and focus group discussion

    Science.gov (United States)

    Boswell, Danette; Broom, Margaret; Smith, Judith; Davis, Deborah

    2015-01-01

    Background There are limited data to inform the choice between parental presence at clinical bedside rounds (PPCBR) and non-PPCBR in neonatal intensive care units (NICUs). Methods We performed a single-centre, survey-based, crossed-over randomised trial involving parents of all infants who were admitted to NICU and anticipated to stay >11 days. Parents were randomly assigned using a computer-generated stratified block randomisation protocol to start with PPCBR or non-PPCBR and then crossed over to the other arm after a wash-out period. At the conclusion of each arm, parents completed the ‘NICU Parental Stressor Scale’ (a validated tool) and a satisfaction survey. After completion of the trial, we surveyed all healthcare providers who participated at least in one PPCBR rounding episode. We also offered all participating parents and healthcare providers the opportunity to partake in a focus group discussion regarding PPCBR. Results A total of 72 parents were enrolled in this study, with 63 parents (87%) partially or fully completing the trial. Of the parents who completed the trial, 95% agreed that parents should be allowed to attend clinical bedside rounds. A total of 39 healthcare providers’ surveys were returned and 35 (90%) agreed that parents should be allowed to attend rounds. Nine healthcare providers and 8 parents participated in an interview or focus group, augmenting our understanding of the ways in which PPCBR was beneficial. Conclusions Parents and healthcare providers strongly support PPCBR. NICUs should develop policies allowing PPCBR while mitigating the downsides and concerns of parents and healthcare providers such as decreased education opportunity and confidentiality concerns. Trial registration number Australia and New Zealand Clinical Trials Register number, ACTRN12612000506897. PMID:25711125

  18. Group therapy task training versus individual task training during inpatient stroke rehabilitation: a randomised controlled trial.

    Science.gov (United States)

    Renner, Caroline Ie; Outermans, Jacqueline; Ludwig, Ricarda; Brendel, Christiane; Kwakkel, Gert; Hummelsheim, Horst

    2016-07-01

    To compare the efficacy of intensive daily applied progressive group therapy task training with equally dosed individual progressive task training on self-reported mobility for patients with moderate to severe stroke during inpatient rehabilitation. Randomized controlled clinical trial. In-patient rehabilitation center. A total of 73 subacute patients with stroke who were not able to walk without physical assistance at randomisation. Patients were allocated to group therapy task training (GT) or individual task training (IT). Both interventions were intended to improve walking competency and comprised 30 sessions of 90 minutes over six weeks. Primary outcome was the mobility domain of the Stroke Impact Scale (SIS-3.0). Secondary outcomes were the other domains of SIS-3.0, standing balance, gait speed, walking distance, stair climbing, fatigue, anxiety and depression. No adverse events were reported in either arm of the trial. There were no significant differences between groups for the SIS mobility domain at the end of the intervention (Z= -0.26, P = 0.79). No significant differences between groups were found in gait speed improvements (GT:0.38 ±0.23; IT:0.26±0.35), any other gait related parameters, or in non-physical outcomes such as depression and fatigue. Inpatient group therapy task training for patients with moderate to severe stroke is safe and equally effective as a dose-matched individual task training therapy. Group therapy task training may be delivered as an alternative to individual therapy or as valuable adjunct to increase time spent in gait-related activities. © The Author(s) 2015.

  19. Internet-versus group-administered cognitive behaviour therapy for panic disorder in a psychiatric setting: a randomised trial

    OpenAIRE

    Bergstrom, Jan; Andersson, Gerhard; Ljotsson, Brjann; Ruck, Christian; Andreewitch, Sergej; Karlsson, Andreas; Carlbring, Per; Andersson, Erik; Lindefors, Nils

    2010-01-01

    Background: Internet administered cognitive behaviour therapy (CBT) is a promising new way to deliver psychological treatment, but its effectiveness in regular care settings and in relation to more traditional CBT group treatment has not yet been determined. The primary aim of this study was to compare the effectiveness of Internet- and group administered CBT for panic disorder (with or without agoraphobia) in a randomised trial within a regular psychiatric care setting. The second aim of the...

  20. Intensive group training protocol versus guideline physiotherapy for patients with chronic low back pain: a randomised controlled trial

    OpenAIRE

    van der Roer, Nicole; van Tulder, Maurits; Barendse, Johanna; Knol, Dirk; van Mechelen, Willem; de Vet, Henrica

    2008-01-01

    Intensive group training using principles of graded activity has been proven to be effective in occupational care for workers with chronic low back pain. Objective of the study was to compare the effects of an intensive group training protocol aimed at returning to normal daily activities and guideline physiotherapy for primary care patients with non-specific chronic low back pain. The study was designed as pragmatic randomised controlled trial with a setup of 105 primary care physiotherapist...

  1. Improving non-technical skills (teamwork) in post-partum haemorrhage: A grouped randomised trial.

    Science.gov (United States)

    Letchworth, Pippa M; Duffy, Shane P; Phillips, Dan

    2017-10-01

    To determine the effect of a decision support technology on teamwork and associated non-technical (NTS) and technical skills when teams manage post-partum haemorrhage (PPH) in the simulated environment. Multidisciplinary (MDT) maternity teams were taught how to manage post partum haemorrhage. They were randomised to the intervention: using a decision support mobile digital platform or a control group. Each team managed a post-partum simulation, which was recorded and reviewed by assessors. Primary outcome measures to assess teams NTS were the validated Global Assessment of Obstetric Team Performance (GAOTP) and Clinical Teamwork Scale (CTS). Secondary outcome measures were the 'friends and family test', technical skills, and the System Usability Scale (SUS). Sample size estimation was calculated by using 80% power 5% significance two tailed test (p1=85% p2=40%) n=34. 38 teams from August 2014-February 2016, were recruited, technical issues with failure of recording equipment meant 4 teams were excluded from teamwork analysis (1 intervention 3 control). Teamwork improved across all domains with the intervention (using a decision support mobile digital platform) p teamwork by 25% using CTS and 22% using GAOTP. Fewer technical skills were missed with the intervention (pteamwork is often cited as the cause of failures in care and we report a usable technology that assists with and improves teamwork during an emergency. Copyright © 2017 Elsevier B.V. All rights reserved.

  2. Solution of the within-group multidimensional discrete ordinates transport equations on massively parallel architectures

    Science.gov (United States)

    Zerr, Robert Joseph

    2011-12-01

    The integral transport matrix method (ITMM) has been used as the kernel of new parallel solution methods for the discrete ordinates approximation of the within-group neutron transport equation. The ITMM abandons the repetitive mesh sweeps of the traditional source iterations (SI) scheme in favor of constructing stored operators that account for the direct coupling factors among all the cells and between the cells and boundary surfaces. The main goals of this work were to develop the algorithms that construct these operators and employ them in the solution process, determine the most suitable way to parallelize the entire procedure, and evaluate the behavior and performance of the developed methods for increasing number of processes. This project compares the effectiveness of the ITMM with the SI scheme parallelized with the Koch-Baker-Alcouffe (KBA) method. The primary parallel solution method involves a decomposition of the domain into smaller spatial sub-domains, each with their own transport matrices, and coupled together via interface boundary angular fluxes. Each sub-domain has its own set of ITMM operators and represents an independent transport problem. Multiple iterative parallel solution methods have investigated, including parallel block Jacobi (PBJ), parallel red/black Gauss-Seidel (PGS), and parallel GMRES (PGMRES). The fastest observed parallel solution method, PGS, was used in a weak scaling comparison with the PARTISN code. Compared to the state-of-the-art SI-KBA with diffusion synthetic acceleration (DSA), this new method without acceleration/preconditioning is not competitive for any problem parameters considered. The best comparisons occur for problems that are difficult for SI DSA, namely highly scattering and optically thick. SI DSA execution time curves are generally steeper than the PGS ones. However, until further testing is performed it cannot be concluded that SI DSA does not outperform the ITMM with PGS even on several thousand or tens of

  3. Coarse-grain parallel solution of few-group neutron diffusion equations

    International Nuclear Information System (INIS)

    Sarsour, H.N.; Turinsky, P.J.

    1991-01-01

    The authors present a parallel numerical algorithm for the solution of the finite difference representation of the few-group neutron diffusion equations. The targeted architectures are multiprocessor computers with shared memory like the Cray Y-MP and the IBM 3090/VF, where coarse granularity is important for minimizing overhead. Most of the work done in the past, which attempts to exploit concurrence, has concentrated on the inner iterations of the standard outer-inner iterative strategy. This produces very fine granularity. To coarsen granularity, the authors introduce parallelism at the nested outer-inner level. The problem's spatial domain was partitioned into contiguous subregions and assigned a processor to solve for each subregion independent of all other subregions, hence, processors; i.e., each subregion is treated as a reactor core with imposed boundary conditions. Since those boundary conditions on interior surfaces, referred to as internal boundary conditions (IBCs), are not known, a third iterative level, the recomposition iterations, is introduced to communicate results between subregions

  4. A randomised controlled trial of caseload midwifery care: M@NGO (Midwives @ New Group practice Options

    Directory of Open Access Journals (Sweden)

    Tracy Sally K

    2011-10-01

    Full Text Available Abstract Background Australia has an enviable record of safety for women in childbirth. There is nevertheless growing concern at the increasing level of intervention and consequent morbidity amongst childbearing women. Not only do interventions impact on the cost of services, they carry with them the potential for serious morbidities for mother and infant. Models of midwifery have proliferated in an attempt to offer women less fragmented hospital care. One of these models that is gaining widespread consumer, disciplinary and political support is caseload midwifery care. Caseload midwives manage the care of approximately 35-40 a year within a small Midwifery Group Practice (usually 4-6 midwives who plan their on call and leave within the Group Practice. We propose to compare the outcomes and costs of caseload midwifery care compared to standard or routine hospital care through a randomised controlled trial. Methods/design A two-arm RCT design will be used. Women will be recruited from tertiary women's hospitals in Sydney and Brisbane, Australia. Women allocated to the caseload intervention will receive care from a named caseload midwife within a Midwifery Group Practice. Control women will be allocated to standard or routine hospital care. Women allocated to standard care will receive their care from hospital rostered midwives, public hospital obstetric care and community based general medical practitioner care. All midwives will collaborate with obstetricians and other health professionals as necessary according to the woman's needs. Discussion Data will be collected at recruitment, 36 weeks antenatally, six weeks and six months postpartum by web based or postal survey. With 750 women or more in each of the intervention and control arms the study is powered (based on 80% power; alpha 0.05 to detect a difference in caesarean section rates of 29.4 to 22.9%; instrumental birth rates from 11.0% to 6.8%; and rates of admission to neonatal intensive

  5. A randomised controlled trial of caseload midwifery care: M@NGO (Midwives @ New Group practice Options).

    Science.gov (United States)

    Tracy, Sally K; Hartz, Donna; Hall, Bev; Allen, Jyai; Forti, Amanda; Lainchbury, Anne; White, Jan; Welsh, Alec; Tracy, Mark; Kildea, Sue

    2011-10-26

    Australia has an enviable record of safety for women in childbirth. There is nevertheless growing concern at the increasing level of intervention and consequent morbidity amongst childbearing women. Not only do interventions impact on the cost of services, they carry with them the potential for serious morbidities for mother and infant.Models of midwifery have proliferated in an attempt to offer women less fragmented hospital care. One of these models that is gaining widespread consumer, disciplinary and political support is caseload midwifery care. Caseload midwives manage the care of approximately 35-40 a year within a small Midwifery Group Practice (usually 4-6 midwives who plan their on call and leave within the Group Practice.) We propose to compare the outcomes and costs of caseload midwifery care compared to standard or routine hospital care through a randomised controlled trial. A two-arm RCT design will be used. Women will be recruited from tertiary women's hospitals in Sydney and Brisbane, Australia. Women allocated to the caseload intervention will receive care from a named caseload midwife within a Midwifery Group Practice. Control women will be allocated to standard or routine hospital care. Women allocated to standard care will receive their care from hospital rostered midwives, public hospital obstetric care and community based general medical practitioner care. All midwives will collaborate with obstetricians and other health professionals as necessary according to the woman's needs. Data will be collected at recruitment, 36 weeks antenatally, six weeks and six months postpartum by web based or postal survey. With 750 women or more in each of the intervention and control arms the study is powered (based on 80% power; alpha 0.05) to detect a difference in caesarean section rates of 29.4 to 22.9%; instrumental birth rates from 11.0% to 6.8%; and rates of admission to neonatal intensive care of all neonates from 9.9% to 5.8% (requires 721 in each arm

  6. The group-based social skills training SOSTA-FRA in children and adolescents with high functioning autism spectrum disorder--study protocol of the randomised, multi-centre controlled SOSTA--net trial.

    Science.gov (United States)

    Freitag, Christine M; Cholemkery, Hannah; Elsuni, Leyla; Kroeger, Anne K; Bender, Stephan; Kunz, Cornelia Ursula; Kieser, Meinhard

    2013-01-07

    Group-based social skills training (SST) has repeatedly been recommended as treatment of choice in high-functioning autism spectrum disorder (HFASD). To date, no sufficiently powered randomised controlled trial has been performed to establish efficacy and safety of SST in children and adolescents with HFASD. In this randomised, multi-centre, controlled trial with 220 children and adolescents with HFASD it is hypothesized, that add-on group-based SST using the 12 weeks manualised SOSTA-FRA program will result in improved social responsiveness (measured by the parent rated social responsiveness scale, SRS) compared to treatment as usual (TAU). It is further expected, that parent and self reported anxiety and depressive symptoms will decline and pro-social behaviour will increase in the treatment group. A neurophysiological study in the Frankfurt HFASD subgroup will be performed pre- and post treatment to assess changes in neural function induced by SST versus TAU. The SOSTA - net trial is designed as a prospective, randomised, multi-centre, controlled trial with two parallel groups. The primary outcome is change in SRS score directly after the intervention and at 3 months follow-up. Several secondary outcome measures are also obtained. The target sample consists of 220 individuals with ASD, included at the six study centres. This study is currently one of the largest trials on SST in children and adolescents with HFASD worldwide. Compared to recent randomised controlled studies, our study shows several advantages with regard to in- and exclusion criteria, study methods, and the therapeutic approach chosen, which can be easily implemented in non-university-based clinical settings. ISRCTN94863788--SOSTA--net: Group-based social skills training in children and adolescents with high functioning autism spectrum disorder.

  7. The group-based social skills training SOSTA-FRA in children and adolescents with high functioning autism spectrum disorder - study protocol of the randomised, multi-centre controlled SOSTA - net trial

    Directory of Open Access Journals (Sweden)

    Freitag Christine M

    2013-01-01

    Full Text Available Abstract Background Group-based social skills training (SST has repeatedly been recommended as treatment of choice in high-functioning autism spectrum disorder (HFASD. To date, no sufficiently powered randomised controlled trial has been performed to establish efficacy and safety of SST in children and adolescents with HFASD. In this randomised, multi-centre, controlled trial with 220 children and adolescents with HFASD it is hypothesized, that add-on group-based SST using the 12 weeks manualised SOSTA–FRA program will result in improved social responsiveness (measured by the parent rated social responsiveness scale, SRS compared to treatment as usual (TAU. It is further expected, that parent and self reported anxiety and depressive symptoms will decline and pro-social behaviour will increase in the treatment group. A neurophysiological study in the Frankfurt HFASD subgroup will be performed pre- and post treatment to assess changes in neural function induced by SST versus TAU. Methods/design The SOSTA – net trial is designed as a prospective, randomised, multi-centre, controlled trial with two parallel groups. The primary outcome is change in SRS score directly after the intervention and at 3 months follow-up. Several secondary outcome measures are also obtained. The target sample consists of 220 individuals with ASD, included at the six study centres. Discussion This study is currently one of the largest trials on SST in children and adolescents with HFASD worldwide. Compared to recent randomised controlled studies, our study shows several advantages with regard to in- and exclusion criteria, study methods, and the therapeutic approach chosen, which can be easily implemented in non-university-based clinical settings. Trial registration ISRCTN94863788 – SOSTA – net: Group-based social skills training in children and adolescents with high functioning autism spectrum disorder.

  8. Improving distress in dialysis (iDiD): a feasibility two-arm parallel randomised controlled trial of an online cognitive behavioural therapy intervention with and without therapist-led telephone support for psychological distress in patients undergoing haemodialysis.

    Science.gov (United States)

    Hudson, Joanna L; Moss-Morris, Rona; Game, David; Carroll, Amy; McCrone, Paul; Hotopf, Matthew; Yardley, Lucy; Chilcot, Joseph

    2016-04-12

    Psychological distress is common in end-stage kidney disease (ESKD) and is associated with poorer health outcomes. Cognitive behavioural therapy (CBT) is recommended in UK clinical guidelines for the management of depression in people with long-term conditions. Access to skilled therapists competent in managing the competing mental and physical health demands of ESKD is limited. Online CBT treatments tailored to the needs of the ESKD population offers a pragmatic solution for under-resourced services. This study examines the feasibility and acceptability of implementing a two-arm parallel randomised controlled trial of online CBT with (intervention arm) and without (control arm) therapist support to improve psychological distress in patients undergoing haemodialysis. Patients will be screened for depression and anxiety while attending for their haemodialysis treatments. We aim to recruit 60 adult patients undergoing haemodialysis who meet criteria for mild to moderately severe symptoms of depression and/or anxiety. Patients will be randomised individually (using a 1:1 computerised sequence ratio) to either online CBT with therapist telephone support (intervention arm), or online CBT with no therapist (control arm). Outcomes include feasibility and acceptability descriptive data on rates of recruitment, randomisation, retention and treatment adherence. Self-report outcomes include measures of depression (Patient Health Questionnaire-9), anxiety (Generalised Anxiety Disorder-7), quality of life (Euro-QoL), service use (client service receipt inventory) and illness cognitions (brief illness perception questionnaire). A qualitative process evaluation will also be conducted. The statistician will be blinded to treatment allocation. A National Health Service (NHS) research ethics committee approved the study. Data from this study will provide essential information for the design and testing of further interventions to ameliorate distress in patients undergoing dialysis

  9. Group versus individual sessions delivered by a physiotherapist for female urinary incontinence: an interview study with women attending group sessions nested within a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Smith Jan

    2009-09-01

    Full Text Available Abstract Background The aim was to explore the concerns and expectations of women invited to attend group physiotherapy sessions for the management of female urinary incontinence and whether the experience changed their views; and to gather recommendations from women attending group sessions on the design and delivery of these sessions Methods An interview study nested within a randomised controlled trial in five British NHS physiotherapy departments, including 22 women who had expressed a preference for an individual physiotherapy session but were randomised to, and attended, group sessions. Results Embarrassment was woven throughout women's accounts of experiencing urinary incontinence and seeking health care. Uncertainty about the nature of group sessions was a source of concern. Attending the first session was seen as a big hurdle by many women. However, a sense of relief was common once the session started, with most women describing some benefit from attendance. Recommendations for design and delivery of the sessions from women focused on reducing embarrassment and uncertainty prior to attendance. Conclusion Taking account of women's embarrassment and providing detailed information about the content of group sessions will enable women to benefit from group physiotherapy sessions for the management of female urinary incontinence. Trial Registration Trial registration number: ISRCTN 16772662

  10. Group treatments for sensitive health care problems: a randomised controlled trial of group versus individual physiotherapy sessions for female urinary incontinence.

    Science.gov (United States)

    Lamb, S E; Pepper, J; Lall, R; Jørstad-Stein, E C; Clark, M D; Hill, L; Fereday-Smith, J

    2009-09-14

    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. 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 a group or individual setting over three weekly sessions. Outcome were measured as Symptom Severity Index; Incontinence-related Quality of Life questionnaire; National Health Service costs, and out of pocket expenses. The majority of women expressed no preference (55%) or preference for individual treatment (36%). Treatment attendance was good, with similar attendance with both service delivery models. Overall, there were no statistically significant differences in symptom severity or quality of life outcomes between the models. Over 85% of women reported a subjective benefit of treatment, with a slightly higher rating in the individual compared with the group setting. When all health care costs were considered, average cost per patient was lower for group sessions (Mean cost difference 52.91 pounds 95%, confidence interval ( 25.82 pounds- 80.00 pounds)). Indications are that whilst some women may have an initial preference for individual treatment, there are no substantial differences in the symptom, quality of life outcomes or non-attendance. Because of the significant difference in mean cost, group treatment is recommended. ISRCTN 16772662.

  11. REMCARE: Pragmatic Multi-Centre Randomised Trial of Reminiscence Groups for People with Dementia and their Family Carers: Effectiveness and Economic Analysis.

    Directory of Open Access Journals (Sweden)

    Robert T Woods

    Full Text Available Joint reminiscence groups, involving people with dementia and family carers together, are popular, but the evidence-base is limited. This study aimed to assess the effectiveness and cost-effectiveness of joint reminiscence groups as compared to usual care.This multi-centre, pragmatic randomised controlled trial had two parallel arms: intervention group and usual-care control group. A restricted dynamic method of randomisation was used, with an overall allocation ratio of 1:1, restricted to ensure viable sized intervention groups. Assessments, blind to treatment allocation, were carried out at baseline, three months and ten months (primary end-point, usually in the person's home. Participants were recruited in eight centres, mainly through NHS Memory Clinics and NHS community mental health teams. Included participants were community resident people with mild to moderate dementia (DSM-IV, who had a relative or other care-giver in regular contact, to act as informant and willing and able to participate in intervention. 71% carers were spouses. 488 people with dementia (mean age 77.5were randomised: 268 intervention, 220 control; 350 dyads completed the study (206 intervention, 144 control. The intervention evaluated was joint reminiscence groups (with up to 12 dyads weekly for twelve weeks; monthly maintenance sessions for further seven months. Sessions followed a published treatment manual and were held in a variety of community settings. Two trained facilitators in each centre were supported by volunteers. Primary outcome measures were self-reported quality of life for the person with dementia (QoL-AD, psychological distress for the carer (General Health Questionnaire, GHQ-28. Secondary outcome measures included: autobiographical memory and activities of daily living for the person with dementia; carer stress for the carer; mood, relationship quality and service use and costs for both.The intention to treat analysis (ANCOVA identified no

  12. Split-mouth and parallel-arm trials to compare pain with intraosseous anaesthesia delivered by the computerised Quicksleeper system and conventional infiltration anaesthesia in paediatric oral healthcare: protocol for a randomised controlled trial

    OpenAIRE

    Smail-Faugeron , Violaine; Muller-Bolla , Michèle; Sixou , Jean-Louis; Courson , Frédéric

    2015-01-01

    Introduction Local anaesthesia is commonly used in paediatric oral healthcare. Infiltration anaesthesia is the most frequently used, but recent developments in anaesthesia techniques have introduced an alternative: intraosseous anaesthesia. We propose to perform a split-mouth and parallel-arm multicentre randomised controlled trial (RCT) comparing the pain caused by the insertion of the needle for the injection of conventional infiltration anaesthesia, and intraosseous anaesthesia by the comp...

  13. Parallel point-multiplication architecture using combined group operations for high-speed cryptographic applications.

    Directory of Open Access Journals (Sweden)

    Md Selim Hossain

    Full Text Available In this paper, we propose a novel parallel architecture for fast hardware implementation of elliptic curve point multiplication (ECPM, which is the key operation of an elliptic curve cryptography processor. The point multiplication over binary fields is synthesized on both FPGA and ASIC technology by designing fast elliptic curve group operations in Jacobian projective coordinates. A novel combined point doubling and point addition (PDPA architecture is proposed for group operations to achieve high speed and low hardware requirements for ECPM. It has been implemented over the binary field which is recommended by the National Institute of Standards and Technology (NIST. The proposed ECPM supports two Koblitz and random curves for the key sizes 233 and 163 bits. For group operations, a finite-field arithmetic operation, e.g. multiplication, is designed on a polynomial basis. The delay of a 233-bit point multiplication is only 3.05 and 3.56 μs, in a Xilinx Virtex-7 FPGA, for Koblitz and random curves, respectively, and 0.81 μs in an ASIC 65-nm technology, which are the fastest hardware implementation results reported in the literature to date. In addition, a 163-bit point multiplication is also implemented in FPGA and ASIC for fair comparison which takes around 0.33 and 0.46 μs, respectively. The area-time product of the proposed point multiplication is very low compared to similar designs. The performance ([Formula: see text] and Area × Time × Energy (ATE product of the proposed design are far better than the most significant studies found in the literature.

  14. Online Diagnosis for the Capacity Fade Fault of a Parallel-Connected Lithium Ion Battery Group

    Directory of Open Access Journals (Sweden)

    Hua Zhang

    2016-05-01

    Full Text Available In a parallel-connected battery group (PCBG, capacity degradation is usually caused by the inconsistency between a faulty cell and other normal cells, and the inconsistency occurs due to two potential causes: an aging inconsistency fault or a loose contacting fault. In this paper, a novel method is proposed to perform online and real-time capacity fault diagnosis for PCBGs. Firstly, based on the analysis of parameter variation characteristics of a PCBG with different fault causes, it is found that PCBG resistance can be taken as an indicator for both seeking the faulty PCBG and distinguishing the fault causes. On one hand, the faulty PCBG can be identified by comparing the PCBG resistance among PCBGs; on the other hand, two fault causes can be distinguished by comparing the variance of the PCBG resistances. Furthermore, for online applications, a novel recursive-least-squares algorithm with restricted memory and constraint (RLSRMC, in which the constraint is added to eliminate the “imaginary number” phenomena of parameters, is developed and used in PCBG resistance identification. Lastly, fault simulation and validation results demonstrate that the proposed methods have good accuracy and reliability.

  15. Can Multiple Lifestyle Behaviours Be Improved in People with Familial Hypercholesterolemia? Results of a Parallel Randomised Controlled Trial

    Science.gov (United States)

    Broekhuizen, Karen; van Poppel, Mireille N. M.; Koppes, Lando L.; Kindt, Iris; Brug, Johannes; van Mechelen, Willem

    2012-01-01

    Objective To evaluate the efficacy of an individualised tailored lifestyle intervention on physical activity, dietary intake, smoking and compliance to statin therapy in people with Familial Hypercholesterolemia (FH). Methods Adults with FH (n = 340) were randomly assigned to a usual care control group or an intervention group. The intervention consisted of web-based tailored lifestyle advice and face-to-face counselling. Physical activity, fat, fruit and vegetable intake, smoking and compliance to statin therapy were self-reported at baseline and after 12 months. Regression analyses were conducted to examine between-group differences. Intervention reach, dose and fidelity were assessed. Results In both groups, non-significant improvements in all lifestyle behaviours were found. Post-hoc analyses showed a significant decrease in saturated fat intake among women in the intervention group (β = −1.03; CI −1.98/−0.03). In the intervention group, 95% received a log on account, of which 49% logged on and completed one module. Nearly all participants received face-to-face counselling and on average, 4.2 telephone booster calls. Intervention fidelity was low. Conclusions Individually tailored feedback is not superior to no intervention regarding changes in multiple lifestyle behaviours in people with FH. A higher received dose of computer-tailored interventions should be achieved by uplifting the website and reducing the burden of screening questionnaires. Counsellor training should be more extensive. Trial Registration Dutch Trial Register NTR1899 PMID:23251355

  16. Study protocol: a phase III randomised, double-blind, parallel arm, stratified, block randomised, placebo-controlled trial investigating the clinical effect and cost-effectiveness of sertraline for the palliative relief of breathlessness in people with chronic breathlessness.

    Science.gov (United States)

    Watts, Gareth J; Clark, Katherine; Agar, Meera; Davidson, Patricia M; McDonald, Christine; Lam, Lawrence T; Sajkov, Dimitar; McCaffrey, Nicola; Doogue, Matthew; Abernethy, Amy P; Currow, David C

    2016-11-29

    Breathlessness remains a highly prevalent and distressing symptom for many patients with progressive life-limiting illnesses. Evidence-based interventions for chronic breathlessness are limited, and there is an ongoing need for high-quality research into developing management strategies for optimal palliation of this complex symptom. Previous studies have suggested that selective serotonin reuptake inhibitors such as sertraline may have a role in reducing breathlessness. This paper presents the protocol for a large, adequately powered randomised study evaluating the use of sertraline for chronic breathlessness in people with progressive life-limiting illnesses. A total of 240 participants with modified Medical Research Council Dyspnoea Scale breathlessness of level 2 or higher will be randomised to receive either sertraline or placebo for 28 days in this multisite, double-blind study. The dose will be titrated up every 3 days to a maximum of 100 mg daily. The primary outcome will be to compare the efficacy of sertraline with placebo in relieving the intensity of worst breathlessness as assessed by a 0-100 mm Visual Analogue Scale. A number of other outcome measures and descriptors of breathlessness as well as caregiver assessments will also be recorded to ensure adequate analysis of participant breathlessness and to allow an economic analysis to be performed. Participants will also be given the option of continuing blinded treatment until either study data collection is complete or net benefit ceases. Appropriate statistical analysis of primary and secondary outcomes will be used to describe the wealth of data obtained. Ethics approval was obtained at all participating sites. Results of the study will be submitted for publication in peer-reviewed journals and the key findings presented at national and international conferences. ACTRN12610000464066. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a

  17. Nurse-led group consultation intervention reduces depressive symptoms in men with localised prostate cancer: a cluster randomised controlled trial

    International Nuclear Information System (INIS)

    Schofield, Penelope; Gough, Karla; Lotfi-Jam, Kerryann; Bergin, Rebecca; Ugalde, Anna; Dudgeon, Paul; Crellin, Wallace; Schubach, Kathryn; Foroudi, Farshard; Tai, Keen Hun; Duchesne, Gillian; Sanson-Fisher, Rob; Aranda, Sanchia

    2016-01-01

    Radiotherapy for localised prostate cancer has many known and distressing side effects. The efficacy of group interventions for reducing psychological morbidity is lacking. This study investigated the relative benefits of a group nurse-led intervention on psychological morbidity, unmet needs, treatment-related concerns and prostate cancer-specific quality of life in men receiving curative intent radiotherapy for prostate cancer. This phase III, two-arm cluster randomised controlled trial included 331 men (consent rate: 72 %; attrition: 5 %) randomised to the intervention (n = 166) or usual care (n = 165). The intervention comprised four group and one individual consultation all delivered by specialist uro-oncology nurses. Primary outcomes were anxious and depressive symptoms as assessed by the Hospital Anxiety and Depression Scale. Unmet needs were assessed with the Supportive Care Needs Survey-SF34 Revised, treatment-related concerns with the Cancer Treatment Scale and quality of life with the Expanded Prostate Cancer Index −26. Assessments occurred before, at the end of and 6 months post-radiotherapy. Primary outcome analysis was by intention-to-treat and performed by fitting a linear mixed model to each outcome separately using all observed data. Mixed models analysis indicated that group consultations had a significant beneficial effect on one of two primary endpoints, depressive symptoms (p = 0.009), and one of twelve secondary endpoints, procedural concerns related to cancer treatment (p = 0.049). Group consultations did not have a significant beneficial effect on generalised anxiety, unmet needs and prostate cancer-specific quality of life. Compared with individual consultations offered as part of usual care, the intervention provides a means of delivering patient education and is associated with modest reductions in depressive symptoms and procedural concerns. Future work should seek to confirm the clinical feasibility and cost-effectiveness of group

  18. Group treatments for sensitive health care problems: a randomised controlled trial of group versus individual physiotherapy sessions for female urinary incontinence

    Directory of Open Access Journals (Sweden)

    Clark MD

    2009-09-01

    Full Text Available 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 a group or individual setting over three weekly sessions. Outcome were measured as Symptom Severity Index; Incontinence-related Quality of Life questionnaire; National Health Service costs, and out of pocket expenses. Results The majority of women expressed no preference (55% or preference for individual treatment (36%. Treatment attendance was good, with similar attendance with both service delivery models. Overall, there were no statistically significant differences in symptom severity or quality of life outcomes between the models. Over 85% of women reported a subjective benefit of treatment, with a slightly higher rating in the individual compared with the group setting. When all health care costs were considered, average cost per patient was lower for group sessions (Mean cost difference £52.91 95%, confidence interval (£25.82 - £80.00. Conclusion Indications are that whilst some women may have an initial preference for individual treatment, there are no substantial differences in the symptom, quality of life outcomes or non-attendance. Because of the significant difference in mean cost, group treatment is recommended. Trial Registration Trial Registration number: ISRCTN 16772662

  19. Compactness of the automorphism group of a topological parallelism on real projective 3-space: The disconnected case

    OpenAIRE

    Rainer, Löwen

    2017-01-01

    We prove that the automorphism group of a topological parallelism on real projective 3-space is compact. In a preceding article it was proved that at least the connected component of the identity is compact. The present proof does not depend on that earlier result.

  20. The Effectiveness of Picture Exchange Communication System (PECS) Training for Teachers of Children with Autism: A Pragmatic, Group Randomised Controlled Trial

    Science.gov (United States)

    Howlin, Patricia; Gordon, R. Kate; Pasco, Greg; Wade, Angie; Charman, Tony

    2007-01-01

    Objective: To assess the effectiveness of expert training and consultancy for teachers of children with autism spectrum disorder in the use of the Picture Exchange Communication System (PECS). Method: Design: Group randomised, controlled trial (3 groups: immediate treatment, delayed treatment, no treatment). Participants: 84 elementary school…

  1. Habit reversal training and educational group treatments for children with tourette syndrome: A preliminary randomised controlled trial.

    Science.gov (United States)

    Yates, Rachel; Edwards, Katie; King, John; Luzon, Olga; Evangeli, Michael; Stark, Daniel; McFarlane, Fiona; Heyman, Isobel; İnce, Başak; Kodric, Jana; Murphy, Tara

    2016-05-01

    Quality of life of children with Tourette Syndrome (TS) is impacted greatly by its symptoms and their social consequences. Habit Reversal Training (HRT) is effective but has not, until now, been empirically evaluated in groups. This randomised controlled trial evaluated feasibility and preliminary efficacy of eight HRT group sessions compared to eight Education group sessions. Thirty-three children aged 9-13 years with TS or Chronic Tic Disorder took part. Outcomes evaluated were tic severity and quality of life (QoL). Tic severity improvements were found in both groups. Motor tic severity (Yale Global Tic Severity Scale) showed greatest improvements in the HRT group. Both groups showed a strong tendency toward improvements in patient reported QoL. In conclusion, group-based treatments for TS are feasible and exposure to other children with tics did not increase tic expression. HRT led to greater reductions in tic severity than Education. Implications, such as cost-effectiveness of treatment delivery, are discussed. Copyright © 2016. Published by Elsevier Ltd.

  2. Smoking cessation at the workplace. Results of a randomised controlled intervention study. Worksite physicians from the AIREL group.

    Science.gov (United States)

    Lang, T; Nicaud, V; Slama, K; Hirsch, A; Imbernon, E; Goldberg, M; Calvel, L; Desobry, P; Favre-Trosson, J P; Lhopital, C; Mathevon, P; Miara, D; Miliani, A; Panthier, F; Pons, G; Roitg, C; Thoores, M

    2000-05-01

    To compare the effects of a worksite intervention by the occupational physician offering simple advice of smoking cessation with a more active strategy of advice including a "quit date" and extra support. Employees of an electrical and gas company seen at the annual visit by their occupational physicians. CRITERIA END POINTS: Smoking point prevalence defined as the percentage of smokers who were non-smokers at one year. Secondary criteria were the percentage of smokers who stopped smoking for more than six months and the difference in prevalence of smoking in both groups. Randomised controlled trial. The unit of randomisation was the work site physician and a random sample of the employees of whom he or she was in charge. The length of the follow up was one year. Each of 30 work site physicians included in the study 100 to 150 employees. Among 504 subjects classified as smokers at baseline receiving simple advice (group A) and 591 the more active programme (group B), 68 (13.5%) in group A and 109 (18. 4%) were non-smokers one year later (p=0.03; p=0.01 taking the occupational physician as the statistical unit and using a non-parametric test). Twenty three subjects (4.6%) in group A and 36 (6.1%) in group B (p=0.26) declared abstinence of six months or more. Among non-smokers at baseline, 3.4% in both groups were smokers after one year follow up. The prevalence of smokers did not differ significantly at baseline (32.9% and 32.4%, p=0.75). After the intervention the prevalence of smoking was 30.8% in group A and 28. 7% in group B (p=0.19). An increase of the mean symptoms score for depression in those who quit was observed during this period. A simple cessation intervention strategy during a mandatory annual examination, targeting a population of smokers independently of their motivation to stop smoking or their health status, showed a 36% relative increase of the proportion of smokers who quit smoking as compared with what can be achieved through simple advice.

  3. Parallel Expansions of Sox Transcription Factor Group B Predating the Diversifications of the Arthropods and Jawed Vertebrates

    Science.gov (United States)

    Zhong, Lei; Wang, Dengqiang; Gan, Xiaoni; Yang, Tong; He, Shunping

    2011-01-01

    Group B of the Sox transcription factor family is crucial in embryo development in the insects and vertebrates. Sox group B, unlike the other Sox groups, has an unusually enlarged functional repertoire in insects, but the timing and mechanism of the expansion of this group were unclear. We collected and analyzed data for Sox group B from 36 species of 12 phyla representing the major metazoan clades, with an emphasis on arthropods, to reconstruct the evolutionary history of SoxB in bilaterians and to date the expansion of Sox group B in insects. We found that the genome of the bilaterian last common ancestor probably contained one SoxB1 and one SoxB2 gene only and that tandem duplications of SoxB2 occurred before the arthropod diversification but after the arthropod-nematode divergence, resulting in the basal repertoire of Sox group B in diverse arthropod lineages. The arthropod Sox group B repertoire expanded differently from the vertebrate repertoire, which resulted from genome duplications. The parallel increases in the Sox group B repertoires of the arthropods and vertebrates are consistent with the parallel increases in the complexity and diversification of these two important organismal groups. PMID:21305035

  4. Broad-spectrum antibiotics for spontaneous preterm labour: the ORACLE II randomised trial. ORACLE Collaborative Group.

    Science.gov (United States)

    Kenyon, S L; Taylor, D J; Tarnow-Mordi, W

    2001-03-31

    Preterm birth after spontaneous preterm labour is associated with death, neonatal disease, and long-term disability. Previous small trials of antibiotics for spontaneous preterm labour have reported inconclusive results. We did a randomised multicentre trial to resolve this issue. 6295 women in spontaneous preterm labour with intact membranes and without evidence of clinical infection were randomly assigned 250 mg erythromycin (n=1611), 325 mg co-amoxiclav (250 mg amoxicillin and 125 mg clavulanic acid; n=1550), both (n=1565), or placebo (n=1569) four times daily for 10 days or until delivery, whichever occurred earlier. The primary outcome measure was a composite of neonatal death, chronic lung disease, or major cerebral abnormality on ultrasonography before discharge from hospital. Analysis was by intention to treat. None of the trial antibiotics was associated with a lower rate of the composite primary outcome than placebo (erythromycin 90 [5.6%], co-amoxiclav 76 [5.0%], both antibiotics 91 [5.9%], vs placebo 78 [5.0%]). However, antibiotic prescription was associated with a lower occurrence of maternal infection. This trial provides evidence that antibiotics should not be routinely prescribed for women in spontaneous preterm labour without evidence of clinical infection.

  5. The effect of reflexology upon spasticity and function among children with cerebral palsy who received physiotherapy: Three group randomised trial.

    Science.gov (United States)

    Özkan, Filiz; Zincir, Handan

    2017-08-01

    To assess the effectiveness of reflexology method upon spasticity and function among children with cerebral palsy who received physiotherapy. A three group, randomised trial with blinded evaluator. Randomization was made sealed and opaque envelopes. 45 children with cerebral palsy who were trained at a Special Education and Rehabilitation Centre. In the reflexology and placebo group; a 20min reflexology was performed twice a week in a total 24 sessions. In the control group; no intervention was done. Before and after the implementation; measurements of the participants were obtained. The data were collected using Gross Motor Function Measure, Modified Ashworth Scale (MAS), Modified Tardieu Scale, Pediatric Functional Independence Scale, Pediatric Quality of Life Scale (PedsQL) and demographic data. A total of 45 children completed the study. The groups were homogeneous at baseline. Between right MAS Gastrocnemius muscle was a difference and right and left Soleus muscles was significant among the groups (p0.05). Reflexology with physiotherapy reduced spasticity in legs, improved gross motor functions, decreased dependency but led to no change in quality of life. Copyright © 2017 Elsevier Inc. All rights reserved.

  6. Reminiscence groups for people with dementia and their family carers: pragmatic eight-centre randomised trial of joint reminiscence and maintenance versus usual treatment: a protocol

    Directory of Open Access Journals (Sweden)

    Orrell Martin

    2009-07-01

    Full Text Available Abstract Background The growing number of people with dementia, and the increasing cost of care, provides a major incentive to develop and test methods of supporting them in the community for longer. Most attention has been given to pharmacological interventions, but there is increasing recognition that psychosocial interventions may be equally effective, even preferable where medication has negative side-effects. Reminiscence groups, run by professionals and volunteers, which use photographs, recordings and other objects to trigger personal memories are probably the most popular therapeutic approach to working with people with dementia, but there is little evidence for their effectiveness and cost-effectiveness. The recent inclusion of family carers in groups with people with dementia, notably in our own pilot studies, has generated informal evidence that this joint approach improves relationships between people with dementia and their carers, and benefits both. Design and methods This multi-centre, pragmatic randomised controlled trial (RCT to assess the effectiveness and cost-effectiveness of joint reminiscence groups for people with dementia and their family care-givers has two parallel arms – an intervention group and a control group who receive care as usual. The intervention consists of joint reminiscence groups held weekly for twelve consecutive weeks, followed by monthly maintenance sessions for a further seven months. The primary outcome measures are the quality of life of people with dementia, as assessed by QoL-AD, and their care-givers' mental health as assessed by the GHQ-28. Secondary outcomes include: the autobiographical memories of people with dementia; the quality of the relationship between them and their care-givers; and the levels of depression and anxiety felt by them and their care-giver. Using a 5% significance level, comparison of 200 pairs attending joint reminiscence groups with 200 pairs receiving usual treatment

  7. Group versus individual stress management intervention in breast cancer patients for fatigue and emotional reactivity: a randomised intervention study.

    Science.gov (United States)

    Rissanen, Ritva; Arving, Cecilia; Ahlgren, Johan; Nordin, Karin

    2014-09-01

    Fatigue and emotional reactivity are common among women suffering from breast cancer and might detrimentally affect these women's quality of life. This study evaluates if the stress management delivered either in a group or individual setting would improve fatigue and emotional reactivity among women with a newly diagnosed breast cancer. Participants (n = 304) who reported elevated levels of distress at three-month post-inclusion were randomised between stress management in a group (GSM) (n = 77) or individual (ISM) (n = 78) setting. Participation was declined by 149 women. Participants completed the Multidimensional Fatigue Inventory (MFI-20) and the Everyday Life Stress Scale (ELSS) at the time of inclusion, 3- and 12-month post-inclusion. Analyses were made according to intention to treat and per-protocol principles. Mann-Whitney tests were used to examine differences between the two intervention groups. No significant differences were detected between the GSM and ISM groups on fatigue or emotional reactivity. In addition, there were no changes over time for these outcomes. There were no differences between the two intervention arms with reference to fatigue or emotional reactivity; however, a clinically interesting finding was the low number of women who were interested in participating in a psychosocial intervention. This finding may have clinical implications when psychosocial support is offered to women with a newly diagnosed breast cancer and also in the planning of future studies.

  8. The effectiveness of an online support group for members of the community with depression: a randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Kathleen M Griffiths

    Full Text Available BACKGROUND: Internet support groups (ISGs are popular, particularly among people with depression, but there is little high quality evidence concerning their effectiveness. AIM: The study aimed to evaluate the efficacy of an ISG for reducing depressive symptoms among community members when used alone and in combination with an automated Internet-based psychotherapy training program. METHOD: Volunteers with elevated psychological distress were identified using a community-based screening postal survey. Participants were randomised to one of four 12-week conditions: depression Internet Support Group (ISG, automated depression Internet Training Program (ITP, combination of the two (ITP+ISG, or a control website with delayed access to e-couch at 6 months. Assessments were conducted at baseline, post-intervention, 6 and 12 months. RESULTS: There was no change in depressive symptoms relative to control after 3 months of exposure to the ISG. However, both the ISG alone and the combined ISG+ITP group showed significantly greater reduction in depressive symptoms at 6 and 12 months follow-up than the control group. The ITP program was effective relative to control at post-intervention but not at 6 months. CONCLUSIONS: ISGs for depression are promising and warrant further empirical investigation. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN65657330.

  9. Randomised study versus control group of customised therapeutic education for patients in follow-up for rheumatoid arthritis.

    Science.gov (United States)

    Pot-Vaucel, Marianne; Aubert, Marie-Pierre; Guillot, Pascale; Glémarec, Joëlle; Berthelot, Jean-Marie; Le Goff, Benoit; Maugars, Yves

    2016-03-01

    We have evaluated customized objectives, predefined during a therapeutic education session for rheumatoid arthritis (RA). Fifty-four RA patients were randomised into patient therapeutic education (PTE) group versus waiting list (WL). The final comparative evaluation involved solving 3 predefined problems. Fifty-four were evaluated after 6 months. The main criterion was defined for all three of the chosen themes at 76.9% in the PTE group and 42.4% in the WL group. Among the other positively evaluated criteria were: less corticotherapy, more occupational therapy, more demand for social aid, more physical activity, knowledge of the recognition of an RA attack and how to cope with it. On the other hand, knowledge of the treatments did not differ between the 2 groups nor did the RAPID scores, fatigue, stiffness, depression, compliance, number of consultations and hospitalisations. Patient satisfaction was excellent (between 85.3 and 93.9%). This study is a good illustration of the position occupied and value of PTE in solving the problems specific to each RA case, the resulting high level of patient satisfaction and its independently complementary aspects relative to the purely medical treatment of RA. Customized PTE could better respond to specific patients problems in RA. Copyright © 2015 Société française de rhumatologie. Published by Elsevier SAS. All rights reserved.

  10. Group Trauma-Focused Cognitive-Behavioural Therapy with Former Child Soldiers and Other War-Affected Boys in the DR Congo: A Randomised Controlled Trial

    Science.gov (United States)

    McMullen, John; O'Callaghan, Paul; Shannon, Ciaran; Black, Alastair; Eakin, John

    2013-01-01

    Background: The Democratic Republic of Congo (DRC) has been home to the world's deadliest conflict since World War II and is reported to have the largest number of child soldiers in the world. Despite evidence of the debilitating impact of war, no group-based mental health or psychosocial intervention has been evaluated in a randomised controlled…

  11. 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.

    2014-01-01

    Aim: To determine the effect of parent education on adaptive behaviour, autism symptoms and cognitive/language skills of young children with autistic disorder. Method: A randomised group comparison design involving a parent education and counselling intervention and a parent education and behaviour management intervention to control for parent…

  12. Intensive group training protocol versus guideline physiotherapy for patients with chronic low back pain: a randomised controlled trial.

    Science.gov (United States)

    van der Roer, Nicole; van Tulder, Maurits; Barendse, Johanna; Knol, Dirk; van Mechelen, Willem; de Vet, Henrica

    2008-09-01

    Intensive group training using principles of graded activity has been proven to be effective in occupational care for workers with chronic low back pain. Objective of the study was to compare the effects of an intensive group training protocol aimed at returning to normal daily activities and guideline physiotherapy for primary care patients with non-specific chronic low back pain. The study was designed as pragmatic randomised controlled trial with a setup of 105 primary care physiotherapists in 49 practices and 114 patients with non-specific low back pain of more than 12 weeks duration participated in the study. In the intensive group training protocol exercise therapy, back school and operant-conditioning behavioural principles are combined. Patients were treated during 10 individual sessions along 20 group sessions. Usual care consisted of physiotherapy according to the Dutch guidelines for Low Back Pain. Main outcome measures were functional disability (Roland Morris disability questionnaire), pain intensity, perceived recovery and sick leave because of low back pain assessed at baseline and after 6, 13, 26 and 52 weeks. Both an intention-to-treat analysis and a per-protocol analysis were performed. Multilevel analysis did not show significant differences between both treatment groups on any outcome measures during the complete follow-up period, with one exception. After 26 weeks the protocol group showed more reduction in pain intensity than the guideline group, but this difference was absent after 52 weeks. We finally conclude that an intensive group training protocol was not more effective than usual physiotherapy for chronic low back pain.

  13. Numeric algorithms for parallel processors computer architectures with applications to the few-groups neutron diffusion equations

    International Nuclear Information System (INIS)

    Zee, S.K.

    1987-01-01

    A numeric algorithm and an associated computer code were developed for the rapid solution of the finite-difference method representation of the few-group neutron-diffusion equations on parallel computers. Applications of the numeric algorithm on both SIMD (vector pipeline) and MIMD/SIMD (multi-CUP/vector pipeline) architectures were explored. The algorithm was successfully implemented in the two-group, 3-D neutron diffusion computer code named DIFPAR3D (DIFfusion PARallel 3-Dimension). Numerical-solution techniques used in the code include the Chebyshev polynomial acceleration technique in conjunction with the power method of outer iteration. For inner iterations, a parallel form of red-black (cyclic) line SOR with automated determination of group dependent relaxation factors and iteration numbers required to achieve specified inner iteration error tolerance is incorporated. The code employs a macroscopic depletion model with trace capability for selected fission products' transients and critical boron. In addition to this, moderator and fuel temperature feedback models are also incorporated into the DIFPAR3D code, for realistic simulation of power reactor cores. The physics models used were proven acceptable in separate benchmarking studies

  14. High performance computing of density matrix renormalization group method for 2-dimensional model. Parallelization strategy toward peta computing

    International Nuclear Information System (INIS)

    Yamada, Susumu; Igarashi, Ryo; Machida, Masahiko; Imamura, Toshiyuki; Okumura, Masahiko; Onishi, Hiroaki

    2010-01-01

    We parallelize the density matrix renormalization group (DMRG) method, which is a ground-state solver for one-dimensional quantum lattice systems. The parallelization allows us to extend the applicable range of the DMRG to n-leg ladders i.e., quasi two-dimension cases. Such an extension is regarded to bring about several breakthroughs in e.g., quantum-physics, chemistry, and nano-engineering. However, the straightforward parallelization requires all-to-all communications between all processes which are unsuitable for multi-core systems, which is a mainstream of current parallel computers. Therefore, we optimize the all-to-all communications by the following two steps. The first one is the elimination of the communications between all processes by only rearranging data distribution with the communication data amount kept. The second one is the avoidance of the communication conflict by rescheduling the calculation and the communication. We evaluate the performance of the DMRG method on multi-core supercomputers and confirm that our two-steps tuning is quite effective. (author)

  15. A parallel algorithm for solving the multidimensional within-group discrete ordinates equations with spatial domain decomposition - 104

    International Nuclear Information System (INIS)

    Zerr, R.J.; Azmy, Y.Y.

    2010-01-01

    A spatial domain decomposition with a parallel block Jacobi solution algorithm has been developed based on the integral transport matrix formulation of the discrete ordinates approximation for solving the within-group transport equation. The new methodology abandons the typical source iteration scheme and solves directly for the fully converged scalar flux. Four matrix operators are constructed based upon the integral form of the discrete ordinates equations. A single differential mesh sweep is performed to construct these operators. The method is parallelized by decomposing the problem domain into several smaller sub-domains, each treated as an independent problem. The scalar flux of each sub-domain is solved exactly given incoming angular flux boundary conditions. Sub-domain boundary conditions are updated iteratively, and convergence is achieved when the scalar flux error in all cells meets a pre-specified convergence criterion. The method has been implemented in a computer code that was then employed for strong scaling studies of the algorithm's parallel performance via a fixed-size problem in tests ranging from one domain up to one cell per sub-domain. Results indicate that the best parallel performance compared to source iterations occurs for optically thick, highly scattering problems, the variety that is most difficult for the traditional SI scheme to solve. Moreover, the minimum execution time occurs when each sub-domain contains a total of four cells. (authors)

  16. A randomised controlled trial of carer-focussed multi-family group psychoeducation in bipolar disorder.

    LENUS (Irish Health Repository)

    Madigan, K

    2012-05-01

    In a RCT of family psychoeducation, 47 carers of 34 patients were allocated to one of three groups; Multifamily Group Psychoeducation, Solution Focussed Group Therapy or Treatment as Usual. Carers in both the MFGP intervention and the SFGP arm demonstrated greater knowledge and reduction in burden than those in the TAU arm.

  17. Cost effectiveness of group follow-up after structured education for type 1 diabetes: a cluster randomised controlled trial

    Science.gov (United States)

    2014-01-01

    Background This study examines the cost effectiveness of group follow-up after participation in the Dose Adjustment for Normal Eating (DAFNE) structured education programme for type 1 diabetes. Methods Economic evaluation conducted alongside a cluster randomised controlled trial involving 437 adults with type 1 diabetes in Ireland. Group follow-up involved two group education ‘booster’ sessions post-DAFNE. Individual follow-up involved two standard one-to-one hospital clinic visits. Incremental costs, quality-adjusted life years (QALYs) gained and cost effectiveness were estimated at 18 months. Uncertainty was explored using sensitivity analysis and by estimating cost effectiveness acceptability curves. Results Group follow-up was associated with a mean reduction in QALYs gained of 0.04 per patient (P value, 0.052; 95% CI, −0.08 to 0.01, intra-class correlation (ICC), 0.033) and a mean reduction in total healthcare costs of €772 (P value, 0.020; 95% CI, −1,415 to −128: ICC, 0.016) per patient. At alternative threshold values of €5,000, €15,000, €25,000, €35,000, and €45,000, the probability of group follow-up being cost effective was estimated to be 1.000, 0.762, 0.204, 0.078, and 0.033 respectively. Conclusions The results do not support implementation of group follow-up as the sole means of follow-up post-DAFNE. Given the reported cost savings, future studies should explore the cost effectiveness of alternative models of group care for diabetes. Trial registration Current Controlled Trials ISRCTN79759174 (assigned: 9 February 2007). PMID:24927851

  18. Icotinib versus whole-brain irradiation in patients with EGFR-mutant non-small-cell lung cancer and multiple brain metastases (BRAIN): a multicentre, phase 3, open-label, parallel, randomised controlled trial.

    Science.gov (United States)

    Yang, Jin-Ji; Zhou, Caicun; Huang, Yisheng; Feng, Jifeng; Lu, Sun; Song, Yong; Huang, Cheng; Wu, Gang; Zhang, Li; Cheng, Ying; Hu, Chengping; Chen, Gongyan; Zhang, Li; Liu, Xiaoqing; Yan, Hong Hong; Tan, Fen Lai; Zhong, Wenzhao; Wu, Yi-Long

    2017-09-01

    For patients with non-small-cell lung cancer (NSCLC) and multiple brain metastases, whole-brain irradiation (WBI) is a standard-of-care treatment, but its effects on neurocognition are complex and concerning. We compared the efficacy of an epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI), icotinib, versus WBI with or without chemotherapy in a phase 3 trial of patients with EGFR-mutant NSCLC and multiple brain metastases. We did a multicentre, open-label, parallel randomised controlled trial (BRAIN) at 17 hospitals in China. Eligible participants were patients with NSCLC with EGFR mutations, who were naive to treatment with EGFR-TKIs or radiotherapy, and had at least three metastatic brain lesions. We randomly assigned participants (1:1) to either icotinib 125 mg orally (three times per day) or WBI (30 Gy in ten fractions of 3 Gy) plus concurrent or sequential chemotherapy for 4-6 cycles, until unacceptable adverse events or intracranial disease progression occurred. The randomisation was done by the Chinese Thoracic Oncology Group with a web-based allocation system applying the Pocock and Simon minimisation method; groups were stratified by EGFR gene mutation status, treatment line (first line or second line), brain metastases only versus both intracranial and extracranial metastases, and presence or absence of symptoms of intracranial hypertension. Clinicians and patients were not masked to treatment assignment, but individuals involved in the data analysis did not participate in the treatments and were thus masked to allocation. Patients receiving icotinib who had intracranial progression only were switched to WBI plus either icotinib or chemotherapy until further progression; those receiving icotinib who had extracranial progression only were switched to icotinib plus chemotherapy. Patients receiving WBI who progressed were switched to icotinib until further progression. Icotinib could be continued beyond progression if a clinical benefit

  19. Personalised normative feedback for preventing alcohol misuse in university students: Solomon three-group randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Maria T Moreira

    Full Text Available Young people tend to over-estimate peer group drinking levels. Personalised normative feedback (PNF aims to correct this misperception by providing information about personal drinking levels and patterns compared with norms in similar aged peer groups. PNF is intended to raise motivation for behaviour change and has been highlighted for alcohol misuse prevention by the British Government Behavioural Insight Team. The objective of the trial was to assess the effectiveness of PNF with college students for the prevention of alcohol misuse.Solomon three-group randomised controlled trial. 1751 students, from 22 British Universities, allocated to a PNF group, a normal control group, or a delayed measurement control group to allow assessment of any measurement effects. PNF was provided by email. Participants completed online questionnaires at baseline, 6- and 12-months (only 12-months for the delayed measurement controls. Drinking behaviour measures were (i alcohol disorders; (ii frequency; (iii typical quantity, (iv weekly consumption; (v alcohol-related problems; (vi perceived drinking norms; and (vii positive alcohol expectancies. Analyses focused on high-risk drinkers, as well as all students, because of research evidence for the prevention paradox in student drinkers.Follow-up rates were low, with only 50% and 40% responding at 6- and 12-months, respectively, though comparable to similar European studies. We found no evidence for any systematic attrition bias. Overall, statistical analyses with the high risk sub-sample, and for all students, showed no significant effects of the intervention, at either time-point, in a completed case analysis and a multiple imputation analysis.We found no evidence for the effectiveness of PNF for the prevention of alcohol misuse and alcohol-related problems in a UK student population.Controlled-Trials.com ISRCTN30784467.

  20. Tailored care for somatoform vertigo/dizziness: study protocol for a randomised controlled trial evaluating integrative group psychotherapy.

    Science.gov (United States)

    Lahmann, Claas; Henningsen, P; Dieterich, M; Radziej, K; Schmid, G

    2015-08-01

    Vertigo/dizziness (VD) ranks high in lifetime prevalence and clinical relevance. Nearly half of the complex VD disorders presenting at specialised units for vertigo or otoneurological disorders are not fully explained by an identifiable medical illness, but instead are related to anxiety, depressive, or somatoform disorders. Although there is some evidence that psychotherapy may be effective for these patients, therapeutic options remain unsatisfactory. This report describes the objectives, design and methods of a randomised, controlled clinical trial, evaluating the efficacy of manualised, multimodal group psychotherapy, based on integrative psychotherapy (IPT) and tailored to subgroups of mental disorders in medically unexplained VD. This psychotherapeutic approach will be compared to self-help groups (n = 172; n = 86 per study arm). Improvements with regard to handicap due to VD at 12 months follow-up will serve as primary outcome. Additionally, measures of generic quality of life, severity of vertigo, depression, anxiety, somatisation as well as Head Impulse Test and Computerized Static Posturography will be applied. We will also analyse the cost-effectiveness of this trial. The study aims to improve treatment of this therapeutically underserved population who are often severely impaired in their working and daily lives. ClinicalTrials.gov Identifier: NCT02320851. This is an on-going study; recruitment for the study is about to start.

  1. The MATISSE study: a randomised trial of group art therapy for people with schizophrenia

    OpenAIRE

    Crawford, M. J.; Killaspy, H.; Kalaitzaki, E.; Barrett, B.; Byford, S.; Patterson, S.; Soteriou, T.; O Neill, F. A.; Clayton, K.; Maratos, A.; Barnes, T. R.; Osborn, D.; Johnson, T.; King, M.; Tyrer, P.

    2010-01-01

    Background: Art Therapy has been promoted as a means of helping people who may find it difficult to express themselves verbally engage in psychological treatment. Group Art Therapy has been widely used as an adjunctive treatment for people with schizophrenia but there have been few attempts to examine its effects and cost effectiveness has not been examined. The MATISSE study aims to evaluate the clinical and cost effectiveness of group Art Therapy for people with schizophrenia.Method/Design:...

  2. Moderating factors for the effectiveness of group art therapy for schizophrenia: secondary analysis of data from the MATISSE randomised controlled trial

    OpenAIRE

    Leurent, Baptiste; Killaspy, Helen; Osborn, David P.; Crawford, Mike J.; Hoadley, Angela; Waller, Diane; King, Michael

    2014-01-01

    PURPOSE Although some studies suggest that art therapy may be useful in the treatment of negative symptoms of schizophrenia, a recent large trial of group art therapy found no clinical advantage over standard care, but the study population was heterogeneous and uptake of the intervention was poor. This study aimed to investigate whether art therapy was more effective for specific subgroups of patients. METHODS Secondary analysis of data from a randomised controlled trial of group art therapy ...

  3. Parent-mediated intervention versus no intervention for infants at high risk of autism: a parallel, single-blind, randomised trial

    Science.gov (United States)

    Green, Jonathan; Charman, Tony; Pickles, Andrew; Wan, Ming W; Elsabbagh, Mayada; Slonims, Vicky; Taylor, Carol; McNally, Janet; Booth, Rhonda; Gliga, Teodora; Jones, Emily J H; Harrop, Clare; Bedford, Rachael; Johnson, Mark H

    2015-01-01

    Summary Background Risk markers for later autism identified in the first year of life present plausible intervention targets during early development. We aimed to assess the effect of a parent-mediated intervention for infants at high risk of autism on these markers. Methods We did a two-site, two-arm assessor-blinded randomised controlled trial of families with an infant at familial high risk of autism aged 7–10 months, testing the adapted Video Interaction to Promote Positive Parenting (iBASIS-VIPP) versus no intervention. Families were randomly assigned to intervention or no intervention groups using a permuted block approach stratified by centre. Assessors, but not families or therapists, were masked to group assignment. The primary outcome was infant attentiveness to parent. Regression analysis was done on an intention-to-treat basis. This trial is registered with ISCRTN Registry, number ISRCTN87373263. Findings We randomly assigned 54 families between April 11, 2011, and Dec 4, 2012 (28 to intervention, 26 to no intervention). Although CIs sometimes include the null, point estimates suggest that the intervention increased the primary outcome of infant attentiveness to parent (effect size 0·29, 95% CI −0·26 to 0·86, thus including possibilities ranging from a small negative treatment effect to a strongly positive treatment effect). For secondary outcomes, the intervention reduced autism-risk behaviours (0·50, CI −0·15 to 1·08), increased parental non-directiveness (0·81, 0·28 to 1·52), improved attention disengagement (0·48, −0·01 to 1·02), and improved parent-rated infant adaptive function (χ2[2] 15·39, p=0·0005). There was a possibility of nil or negative effect in language and responsivity to vowel change (P1: ES–0·62, CI −2·42 to 0·31; P2: −0·29, −1·55 to 0·71). Interpretation With the exception of the response to vowel change, our study showed positive estimates across a wide range of behavioural and brain function

  4. Internet-versus group-administered cognitive behaviour therapy for panic disorder in a psychiatric setting: a randomised trial

    Directory of Open Access Journals (Sweden)

    Karlsson Andreas

    2010-07-01

    Full Text Available Abstract Background Internet administered cognitive behaviour therapy (CBT is a promising new way to deliver psychological treatment, but its effectiveness in regular care settings and in relation to more traditional CBT group treatment has not yet been determined. The primary aim of this study was to compare the effectiveness of Internet-and group administered CBT for panic disorder (with or without agoraphobia in a randomised trial within a regular psychiatric care setting. The second aim of the study was to establish the cost-effectiveness of these interventions. Methods Patients referred for treatment by their physician, or self-referred, were telephone-screened by a psychiatric nurse. Patients fulfilling screening criteria underwent an in-person structured clinical interview carried out by a psychiatrist. A total of 113 consecutive patients were then randomly assigned to 10 weeks of either guided Internet delivered CBT (n = 53 or group CBT (n = 60. After treatment, and at a 6-month follow-up, patients were again assessed by the psychiatrist, blind to treatment condition. Results Immediately after randomization 9 patients dropped out, leaving 104 patients who started treatment. Patients in both treatment conditions showed significant improvement on the main outcome measure, the Panic Disorder Severity Scale (PDSS after treatment. For the Internet treatment the within-group effect size (pre-post on the PDSS was Cohen's d = 1.73, and for the group treatment it was d = 1.63. Between group effect sizes were low and treatment effects were maintained at 6-months follow-up. We found no statistically significant differences between the two treatment conditions using a mixed models approach to account for missing data. Group CBT utilised considerably more therapist time than did Internet CBT. Defining effect as proportion of PDSS responders, the cost-effectiveness analysis concerning therapist time showed that Internet treatment had superior cost

  5. Psychosocial group intervention for patients with primary breast cancer: A randomised trial

    DEFF Research Database (Denmark)

    Boesen, E. H.; Karlsen, R.; Christensen, J.

    2011-01-01

    Purpose: To test the effectiveness of a psycho-educational group intervention to improve psychological distress measured by POMS TMD, Quality of Life measured by European Organisation for Research and Treatment of Cancer (EORTC), the core and breast cancer module, Mental Adjustment measured by MA...

  6. Group problem-solving skills training for self-harm: randomised controlled trial.

    Science.gov (United States)

    McAuliffe, Carmel; McLeavey, Breda C; Fitzgerald, Tony; Corcoran, Paul; Carroll, Bernie; Ryan, Louise; O'Keeffe, Brian; Fitzgerald, Eva; Hickey, Portia; O'Regan, Mary; Mulqueen, Jillian; Arensman, Ella

    2014-01-01

    Rates of self-harm are high and have recently increased. This trend and the repetitive nature of self-harm pose a significant challenge to mental health services. To determine the efficacy of a structured group problem-solving skills training (PST) programme as an intervention approach for self-harm in addition to treatment as usual (TAU) as offered by mental health services. A total of 433 participants (aged 18-64 years) were randomly assigned to TAU plus PST or TAU alone. Assessments were carried out at baseline and at 6-week and 6-month follow-up and repeated hospital-treated self-harm was ascertained at 12-month follow-up. The treatment groups did not differ in rates of repeated self-harm at 6-week, 6-month and 12-month follow-up. Both treatment groups showed significant improvements in psychological and social functioning at follow-up. Only one measure (needing and receiving practical help from those closest to them) showed a positive treatment effect at 6-week (P = 0.004) and 6-month (P = 0.01) follow-up. Repetition was not associated with waiting time in the PST group. This brief intervention for self-harm is no more effective than treatment as usual. Further work is required to establish whether a modified, more intensive programme delivered sooner after the index episode would be effective.

  7. No differences between group versus individual treatment of childhood anxiety disorders in a randomised clinical trial

    NARCIS (Netherlands)

    Liber, Juliette M.; van Widenfelt, Brigit M.; Utens, Elisabeth M. W. J.; Ferdinand, Robert F.; van der Leeden, Adelinde J. M.; van Gastel, Willemijn; Treffers, Philip D. A.

    2008-01-01

    The present study compares an individual versus a group format in the delivery of manualised cognitive-behavioural therapy (FRIENDS) for children with anxiety disorders. Clinically referred children (aged 8 to 12) diagnosed with Separation Anxiety Disorder (n = 52), Generalised Anxiety Disorder (n =

  8. Arbuscular mycorrhizal fungi assemblages in Chernozem great groups revealed by massively parallel pyrosequencing.

    Science.gov (United States)

    Dai, Mulan; Hamel, Chantal; St Arnaud, Marc; He, Yong; Grant, Cynthia; Lupwayi, Newton; Janzen, Henry; Malhi, Sukhdev S; Yang, Xiaohong; Zhou, Zhiqin

    2012-01-01

    The arbuscular mycorrhizal (AM) fungal resources present in wheat fields of the Canadian Prairie were explored using 454 pyrosequencing. Of the 33 dominant AM fungal operational taxonomic units (OTUs) found in the 76 wheat fields surveyed at anthesis in 2009, 14 clustered as Funneliformis - Rhizophagus, 16 as Claroideoglomus, and 3 as Diversisporales. An OTU of Funneliformis mosseae and one OTU of Diversisporales each accounted for approximately 16% of all AM fungal OTUs. The former was ubiquitous, and the latter was mainly restricted to the Black and Dark Brown Chernozems. AM fungal OTU community composition was better explained by the Chernozem great groups (P = 0.044) than by measured soil properties. Fifty-two percent of the AM fungal OTUs were unrelated to measured soil properties. Black Chernozems hosted the largest AM fungal OTU diversity and almost twice the number of AM fungal sequences seen in Dark Brown Chernozems, the great group ranking second for AM fungal sequence abundance. Brown Chernozems hosted the lowest AM fungal abundance and an AM fungal diversity as low as that seen in Gray soils. We concluded that Black Chernozems are most conducive to AM fungal proliferation. AM fungi are generally distributed according to Chernozem great groups in the Canadian Prairie, although some taxa are evenly distributed in all soil groups.

  9. Effect of physical training on urinary incontinence: a randomized parallel group trial in nursing homes

    Directory of Open Access Journals (Sweden)

    Vinsnes AG

    2012-02-01

    Full Text Available Anne G Vinsnes1, Jorunn L Helbostad2, Signe Nyrønning3, Gene E Harkless1,4, Randi Granbo5, Arnfinn Seim61Faculty of Nursing, Sør-Trøndelag University College, 2Department of Neuroscience, Norwegian University of Science and Technology, 3Søbstad Community Hospital and Teaching Nursing Home, Trondheim, Norway; 4University of New Hampshire, College of Health and Social Services, Nursing Faculty, Durham, New Hampshire, USA; 5Department of Physiotherapy, Sør-Trøndelag University College, 6Department of Public Health and General Practice, Norwegian University of Science and Technology, Trondheim, NorwayBackground: Residents in nursing homes (NHs are often frail older persons who have impaired physical activity. Urinary incontinence (UI is a common complaint for residents in NHs. Reduced functional ability and residence in NHs are documented to be risk factors for UI.Objective: To investigate if an individualized training program designed to improve activity of daily living (ADL and physical capacity among residents in nursing homes has any impact on UI.Materials and methods: This randomized controlled trial was a substudy of a Nordic multicenter study. Participants had to be >65 years, have stayed in the NH for more than 3 months and in need of assistance in at least one ADL. A total of 98 residents were randomly allocated to either a training group (n = 48 or a control group (n = 50 after baseline registrations. The training program lasted for 3 months and included accommodated physical activity and ADL training. Personal treatment goals were elicited for each subject. The control group received their usual care. The main outcome measure was UI as measured by a 24-hour pad-weighing test. There was no statistically significant difference between the groups on this measure at baseline (P = 0.15. Changes were calculated from baseline to 3 months after the end of the intervention.Results: Altogether, 68 participants were included in the analysis

  10. Group problem-solving skills training for self-harm: randomised controlled trial

    OpenAIRE

    McAuliffe, Carmel; McLeavey, Breda C.; Fitzgerald, Anthony P.; Corcoran, Paul; Carroll, Bernie; Ryan, Louise; Fitzgerald, Eva; O'Regan, Mary; Mulqueen, Jillian; Arensman, Ella

    2014-01-01

    Background: Rates of self-harm are high and have recently increased. This trend and the repetitive nature of self-harm pose a significant challenge to mental health services. Aims: To determine the efficacy of a structured group problem-solving skills training (PST) programme as an intervention approach for self-harm in addition to treatment as usual (TAU) as offered by mental health services. Method: A total of 433 participants (aged 18-64 years) were randomly assigned to TAU plus PST or TAU...

  11. High dose melphalan in the treatment of advanced neuroblastoma: results of a randomised trial (ENSG-1) by the European Neuroblastoma Study Group.

    Science.gov (United States)

    Pritchard, Jon; Cotterill, Simon J; Germond, Shirley M; Imeson, John; de Kraker, Jan; Jones, David R

    2005-04-01

    High dose myeloablative chemotherapy ("megatherapy"), with haematopoietic stem cell support, is now widely used to consolidate response to induction chemotherapy in patients with advanced neuroblastoma. In this study (European Neuroblastoma Study Group, ENSG1), the value of melphalan myeloablative "megatherapy" was evaluated in a randomised, multi-centre trial. Between 1982 and 1985, 167 children with stages IV and III neuroblastoma (123 stage IV > 1 year old at diagnosis and 44 stage III and stage IV from 6 to 12 months old at diagnosis) were treated with oncovin, cisplatin, epipodophyllotoxin, and cyclophosphamide (OPEC) induction chemotherapy every 3 weeks. After surgical excision of primary tumour, the 90 patients (69% of the total) who achieved complete response (CR) or good partial response (GPR) were eligible for randomisation either to high dose melphalan (180 mg per square meter) with autologous bone marrow support or to no further treatment. Sixty-five (72%) of eligible children were actually randomised and 21 of these patients were surviving at time of this analysis, with median follow-up from randomisation of 14.3 years. Five year event-free survival (EFS) was 38% (95% confidence interval (CI) 21-54%) in the melphalan-treated group and 27% (95% CI 12-42%) in the "no-melphalan" group. This difference was not statistically significant (P = 0.08, log rank test) but for the 48 randomised stage IV patients aged >1 year at diagnosis outcome was significantly better in the melphalan-treated group-5 year EFS 33% versus 17% (P = 0.01, log rank test). In this trial, high dose melphalan improved the length of EFS and overall survival of children with stage IV neuroblastoma >1 year of age who achieved CR or GPR after OPEC induction therapy and surgery. Multi-agent myeloablative regimens are now widely used as consolidation therapy for children with stage IV disease and in those with other disease stages when the MYCN gene copy number in tumour cells is amplified

  12. Large-scale parallel configuration interaction. II. Two- and four-component double-group general active space implementation with application to BiH

    DEFF Research Database (Denmark)

    Knecht, Stefan; Jensen, Hans Jørgen Aagaard; Fleig, Timo

    2010-01-01

    We present a parallel implementation of a large-scale relativistic double-group configuration interaction CIprogram. It is applicable with a large variety of two- and four-component Hamiltonians. The parallel algorithm is based on a distributed data model in combination with a static load balanci...

  13. CT coronary angiography in patients with suspected angina due to coronary heart disease (SCOT-HEART): an open-label, parallel-group, multicentre trial.

    Science.gov (United States)

    2015-06-13

    The benefit of CT coronary angiography (CTCA) in patients presenting with stable chest pain has not been systematically studied. We aimed to assess the effect of CTCA on the diagnosis, management, and outcome of patients referred to the cardiology clinic with suspected angina due to coronary heart disease. In this prospective open-label, parallel-group, multicentre trial, we recruited patients aged 18-75 years referred for the assessment of suspected angina due to coronary heart disease from 12 cardiology chest pain clinics across Scotland. We randomly assigned (1:1) participants to standard care plus CTCA or standard care alone. Randomisation was done with a web-based service to ensure allocation concealment. The primary endpoint was certainty of the diagnosis of angina secondary to coronary heart disease at 6 weeks. All analyses were intention to treat, and patients were analysed in the group they were allocated to, irrespective of compliance with scanning. This study is registered with ClinicalTrials.gov, number NCT01149590. Between Nov 18, 2010, and Sept 24, 2014, we randomly assigned 4146 (42%) of 9849 patients who had been referred for assessment of suspected angina due to coronary heart disease. 47% of participants had a baseline clinic diagnosis of coronary heart disease and 36% had angina due to coronary heart disease. At 6 weeks, CTCA reclassified the diagnosis of coronary heart disease in 558 (27%) patients and the diagnosis of angina due to coronary heart disease in 481 (23%) patients (standard care 22 [1%] and 23 [1%]; pheart disease increased (1·09, 1·02-1·17; p=0·0172), the certainty increased (1·79, 1·62-1·96; pheart disease. This changed planned investigations (15% vs 1%; pheart disease, CTCA clarifies the diagnosis, enables targeting of interventions, and might reduce the future risk of myocardial infarction. The Chief Scientist Office of the Scottish Government Health and Social Care Directorates funded the trial with supplementary awards

  14. Exploring the effects of a universal classroom management training programme on teacher and child behaviour: A group randomised controlled trial and cost analysis

    OpenAIRE

    O'Neill, Donal

    2017-01-01

    Teachers frequently struggle to cope with conduct problems in the classroom. The aim of this study was to assess the effectiveness of the Incredible Years Teacher Classroom Management Training Programme for improving teacher competencies and child adjustment. The study involved a group randomised controlled trial which included 22 teachers and 217 children (102 boys and 115 girls). The average age of children included in the study was 5.3 years (standard deviation = 0.89). Teacher...

  15. Group psychoeducation with relaxation for severe fear of childbirth improves maternal adjustment and childbirth experience--a randomised controlled trial.

    Science.gov (United States)

    Rouhe, Hanna; Salmela-Aro, Katariina; Toivanen, Riikka; Tokola, Maiju; Halmesmäki, Erja; Ryding, Elsa-Lena; Saisto, Terhi

    2015-01-01

    Previous studies on the treatment of women with fear of childbirth have focused on the delivery mode. Women with fear of childbirth often suffer from anxiety and/or depression, and treatment therefore also needs to target postnatal psychological well-being and the early mother-infant relationship. Three hundred and seventy-one nulliparous women out of 4575 scored ≥100 in prospective screening (Wijma Delivery Expectancy Questionnaire, W-DEQ-A), indicating severe fear of childbirth. These women were randomised to psychoeducative group intervention with relaxation (n = 131; six sessions during pregnancy, one postnatal) or to conventional care (n = 240) by community nurses (referral if necessary). Psycho-emotional and psychosocial evaluations [Edinburgh Postnatal Depression Scale (EPDS), social support, Maternal Adjustment and Attitudes (MAMA), Traumatic Events Scale (TES) and the Wijma Delivery Experience Questionnaire (W-DEQ-B)] were completed twice during pregnancy and/or 3 months postpartum. Postnatal maternal adjustment (MAMA mean score 38.1 ± 4.3 versus 35.7 ± 5.0, p = 0.001) and childbirth experience (mean W-DEQ-B sum score 63.0 ± 29 versus 73.7 ± 32, p = 0.008) were better in the intervention group compared with controls. In hierarchical regression, social support, participating in intervention, and less fearful childbirth experience predicted better maternal adjustment. The level of postnatal depressive symptoms was significantly lower in the intervention group (mean sum score 6.4 ± 5.4 versus 8.0 ± 5.9 p = 0.04). There were no differences in the frequency of post-traumatic stress symptoms between the groups. In nulliparous women with severe fear of childbirth, participation in a targeted psychoeducative group resulted in better maternal adjustment, a less fearful childbirth experience and fewer postnatal depressive symptoms, compared with conventional care.

  16. Optimizing trial design in pharmacogenetics research: comparing a fixed parallel group, group sequential, and adaptive selection design on sample size requirements.

    Science.gov (United States)

    Boessen, Ruud; van der Baan, Frederieke; Groenwold, Rolf; Egberts, Antoine; Klungel, Olaf; Grobbee, Diederick; Knol, Mirjam; Roes, Kit

    2013-01-01

    Two-stage clinical trial designs may be efficient in pharmacogenetics research when there is some but inconclusive evidence of effect modification by a genomic marker. Two-stage designs allow to stop early for efficacy or futility and can offer the additional opportunity to enrich the study population to a specific patient subgroup after an interim analysis. This study compared sample size requirements for fixed parallel group, group sequential, and adaptive selection designs with equal overall power and control of the family-wise type I error rate. The designs were evaluated across scenarios that defined the effect sizes in the marker positive and marker negative subgroups and the prevalence of marker positive patients in the overall study population. Effect sizes were chosen to reflect realistic planning scenarios, where at least some effect is present in the marker negative subgroup. In addition, scenarios were considered in which the assumed 'true' subgroup effects (i.e., the postulated effects) differed from those hypothesized at the planning stage. As expected, both two-stage designs generally required fewer patients than a fixed parallel group design, and the advantage increased as the difference between subgroups increased. The adaptive selection design added little further reduction in sample size, as compared with the group sequential design, when the postulated effect sizes were equal to those hypothesized at the planning stage. However, when the postulated effects deviated strongly in favor of enrichment, the comparative advantage of the adaptive selection design increased, which precisely reflects the adaptive nature of the design. Copyright © 2013 John Wiley & Sons, Ltd.

  17. Intensive Versus Distributed Aphasia Therapy: A Nonrandomized, Parallel-Group, Dosage-Controlled Study.

    Science.gov (United States)

    Dignam, Jade; Copland, David; McKinnon, Eril; Burfein, Penni; O'Brien, Kate; Farrell, Anna; Rodriguez, Amy D

    2015-08-01

    Most studies comparing different levels of aphasia treatment intensity have not controlled the dosage of therapy provided. Consequently, the true effect of treatment intensity in aphasia rehabilitation remains unknown. Aphasia Language Impairment and Functioning Therapy is an intensive, comprehensive aphasia program. We investigated the efficacy of a dosage-controlled trial of Aphasia Language Impairment and Functioning Therapy, when delivered in an intensive versus distributed therapy schedule, on communication outcomes in participants with chronic aphasia. Thirty-four adults with chronic, poststroke aphasia were recruited to participate in an intensive (n=16; 16 hours per week; 3 weeks) versus distributed (n=18; 6 hours per week; 8 weeks) therapy program. Treatment included 48 hours of impairment, functional, computer, and group-based aphasia therapy. Distributed therapy resulted in significantly greater improvements on the Boston Naming Test when compared with intensive therapy immediately post therapy (P=0.04) and at 1-month follow-up (P=0.002). We found comparable gains on measures of participants' communicative effectiveness, communication confidence, and communication-related quality of life for the intensive and distributed treatment conditions at post-therapy and 1-month follow-up. Aphasia Language Impairment and Functioning Therapy resulted in superior clinical outcomes on measures of language impairment when delivered in a distributed versus intensive schedule. The therapy progam had a positive effect on participants' functional communication and communication-related quality of life, regardless of treatment intensity. These findings contribute to our understanding of the effect of treatment intensity in aphasia rehabilitation and have important clinical implications for service delivery models. © 2015 American Heart Association, Inc.

  18. Randomised study of Casodex 50 MG monotherapy vs orchidectomy in the treatment of metastatic prostate cancer. The Scandinavian Casodex Cooperative Group

    DEFF Research Database (Denmark)

    Iversen, P; Tveter, K; Varenhorst, E

    1996-01-01

    The effect of Casodex (ICI 176,334), a new, once-daily, selective antiandrogen, given as 50 mg monotherapy, was compared with orchidectomy in a randomised, multicentre, open study in 376 patients with metastatic prostate cancer. At 3 months, PSA was reduced by 86% in the Casodex group and by 96......% in the orchidectomy group. Treatment failed in 51 patients in the orchidectomy group and 66 showed a subjective response. Treatment failed in 86 patients treated with Casodex and 40 patients showed a subjective response. Patients treated with Casodex maintained their sexual interest better than those...

  19. The effect of motivational interviewing on glycaemic control and perceived competence of diabetes self-management in patients with type 1 and type 2 diabetes mellitus after attending a group education programme: a randomised controlled trial.

    Science.gov (United States)

    Rosenbek Minet, L K; Wagner, L; Lønvig, E M; Hjelmborg, J; Henriksen, J E

    2011-07-01

    The aim of this study was to measure the efficacy of motivational interviewing (MI) compared with usual care on changes in glycaemic control and competence of diabetes self-management in patients with diabetes mellitus. Patients were eligible if they had type 1 or 2 diabetes mellitus, were over 18 years of age and had participated in a 4 day group education programme offered at a diabetes clinic at a university hospital in Denmark. Exclusion criteria included pregnancy, severe debilitating disease and cognitive deficit. Out of 469 patients who attended the group education programme, 349 patients were randomised to either a usual care control group or an intervention group, which received up to five individual counselling sessions in 1 year based on MI, in addition to usual care. A randomised parallel design was used and open-label allocation was done by random permuted blocks, with allocation concealment by sequentially numbered, sealed, opaque envelopes. The primary outcome was glycated haemoglobin (HbA(1c)). Analysis regarding measurements of glycated haemoglobin (HbA(1c)) and competence of self-management (using the Problem Areas in Diabetes Scale [PAID] and Perceived Competence for Diabetes Scale [PCDS]) was based on 298 participants followed for a 24 month period. Data were collected at the Department of Endocrinology at Odense University Hospital. Our hypotheses were that MI could: (1) reduce HbA(1c) levels; (2) increase self-efficacy; and (3) increase diabetes self-care, compared with usual care. Out of the 176 included in the control group and 173 in the intervention group, 153 and 145 were analysed in the groups, respectively. When using the baseline value as covariate there were no significant differences in change score between the two study groups with regard to mean level of HbA(1c) (0.131, p = 0.221), PAID scores (-1.793, p = 0.191) or PCDS scores (0.017, p = 0.903) at the 24 month follow-up, using a mixed effects regression model. The

  20. Exploratory double-blind, parallel-group, placebo-controlled extension study of edaravone (MCI-186) in amyotrophic lateral sclerosis.

    Science.gov (United States)

    2017-10-01

    Following the first phase III study of edaravone for amyotrophic lateral sclerosis (ALS), this extension study was performed to evaluate longer-term efficacy and safety. Patients given edaravone in the first 24-week phase III study (Cycles 1-6) were randomised to edaravone (E-E) or placebo (E-P) in the subsequent 24-week double-blind period (Cycles 7-12). Patients given placebo in phase III were switched to edaravone (P-E). Subsequently, all patients received edaravone for 12 weeks (Cycles 13-15). Efficacy endpoints included revised ALS Functional Rating Scale (ALSFRS-R) score. Analysis populations were the full analysis set (FAS) and the efficacy-expected subpopulation (EESP) defined by post-hoc analysis of the first phase III study. The least-squares mean and standard error of the intergroup difference (E-E vs. E-P) of change in the ALSFRS-R score from Cycles 7-12 was 1.16 ± 0.93 (p = 0.2176) in the FAS, and 1.85 ± 1.14 (p = 0.1127) in the EESP. The ALSFRS-R score changed almost linearly in the E-E group throughout Cycles 1-15 (60 weeks). The incidence of serious adverse events associated with ALS progression was higher in E-E than in E-P. Edaravone might have potential efficacy for up to 15 cycles when used to treat patients in the EESP with careful safety monitoring.

  1. Broad-spectrum antibiotics for preterm, prelabour rupture of fetal membranes: the ORACLE I randomised trial. ORACLE Collaborative Group.

    Science.gov (United States)

    Kenyon, S L; Taylor, D J; Tarnow-Mordi, W

    2001-03-31

    Preterm, prelabour rupture of the fetal membranes (pPROM) is the commonest antecedent of preterm birth, and can lead to death, neonatal disease, and long-term disability. Previous small trials of antibiotics for pPROM suggested some health benefits for the neonate, but the results were inconclusive. We did a randomised multicentre trial to try to resolve this issue. 4826 women with pPROM were randomly assigned 250 mg erythromycin (n=1197), 325 mg co-amoxiclav (250 mg amoxicillin plus 125 mg clavulanic acid; n=1212), both (n=1192), or placebo (n=1225) four times daily for 10 days or until delivery. The primary outcome measure was a composite of neonatal death, chronic lung disease, or major cerebral abnormality on ultrasonography before discharge from hospital. Analysis was by intention to treat. Two women were lost to follow-up, and there were 15 protocol violations. Among all 2415 infants born to women allocated erythromycin only or placebo, fewer had the primary composite outcome in the erythromycin group (151 of 1190 [12.7%] vs 186 of 1225 [15.2%], p=0.08) than in the placebo group. Among the 2260 singletons in this comparison, significantly fewer had the composite primary outcome in the erythromycin group (125 of 1111 [11.2%] vs 166 of 1149 [14.4%], p=0.02). Co-amoxiclav only and co-amoxiclav plus erythromycin had no benefit over placebo with regard to this outcome in all infants or in singletons only. Use of erythromycin was also associated with prolongation of pregnancy, reductions in neonatal treatment with surfactant, decreases in oxygen dependence at 28 days of age and older, fewer major cerebral abnormalities on ultrasonography before discharge, and fewer positive blood cultures. Although co-amoxiclav only and co-amoxiclav plus erythromycin were associated with prolongation of pregnancy, they were also associated with a significantly higher rate of neonatal necrotising enterocolitis. Erythromycin for women with pPROM is associated with a range of health

  2. Double-blind, parallel-group evaluation of etodolac and naproxen in patients with acute sports injuries.

    Science.gov (United States)

    D'Hooghe, M

    1992-01-01

    The efficacy and safety of etodolac and naproxen were compared in a double-blind, randomized, parallel-group outpatient study. Patients with acute sports injuries were assigned to receive either etodolac 300 mg TID (50 patients) or naproxen 500 mg BID (49 patients) for up to 7 days. Assessments were made at the pretreatment screening (baseline) and at days 2, 3, 4, and 7 of treatment. Assessments included patient and physician global evaluations, spontaneous and induced pain intensity, range of motion, tenderness, heat, degree of swelling, and degree of erythema. Safety assessments, including laboratory profiles, were made at pretreatment and at final evaluation; patients' complaints were elicited at all visits. Both treatment groups showed significant (P less than or equal to 0.05) improvement from baseline for all efficacy parameters by day 2 and thereafter at all time points. Improvement was similar for the two groups. No patients in either group withdrew from the study because of drug-related adverse reactions. The results of this study indicate that etodolac (900 mg/day) is effective and well tolerated as an analgesic and anti-inflammatory in acute sports injuries and is comparable to naproxen (1000 mg/day).

  3. Go4it; study design of a randomised controlled trial and economic evaluation of a multidisciplinary group intervention for obese adolescents for prevention of diabetes mellitus type 2

    Directory of Open Access Journals (Sweden)

    Weijs Peter JM

    2008-12-01

    Full Text Available Abstract Background In the Netherlands, the first adolescents with diabetes mellitus type 2 as a result of obesity have recently been diagnosed. Therefore, it is very important that programs aiming at the prevention of type 2 diabetes of obese adolescents are developed and evaluated. Methods Go4it is a multidisciplinary group treatment that focuses on: 1 increasing awareness of the current dietary and physical activity behaviour (i.e. energy balance behaviour, 2 improving diet, 3 decreasing sedentary behaviour, 4 increasing levels of physical activity, and 5 coping with difficult situations. Go4it consists of 7 sessions with an interval of 2–3 weeks. The effectiveness of the multidisciplinary group treatment compared with usual care (i.e. referral to a dietician was evaluated in a randomised controlled trial. We examined effects on BMI(sds, body composition, energy expenditure, glucose tolerance and insulin resistance (primary outcome measure, as well as dietary and physical activity behaviour and quality of life. An economic evaluation from a societal perspective was conducted alongside the randomised trial to evaluate the cost-effectiveness of the multidisciplinary treatment program vs. usual care. Discussion In this paper we described a multidisciplinary treatment program (Go4it for obese adolescents and the design of a randomised controlled trial and economic evaluation to evaluate its effectiveness and cost-effectiveness. Trial registration Netherlands Trial Register (ISRCTN27626398.

  4. Neck collar, "act-as-usual" or active mobilization for whiplash injury? A randomized parallel-group trial

    DEFF Research Database (Denmark)

    Kongsted, Alice; Montvilas, Erisela Qerama; Kasch, Helge

    2007-01-01

    practitioners within 10 days after a whiplash injury and randomized to: 1) immobilization of the cervical spine in a rigid collar followed by active mobilization, 2) advice to "act-as-usual," or 3) an active mobilization program (Mechanical Diagnosis and Therapy). Follow-up was carried out after 3, 6, and 12......-extension trauma to the cervical spine. It is unclear whether this, in some cases disabling, condition can be prevented by early intervention. Active interventions have been recommended but have not been compared with information only. Methods. Participants were recruited from emergency units and general......Study Design. Randomized, parallel-group trial. Objective. To compare the effect of 3 early intervention strategies following whiplash injury. Summary of Background Data. Long-lasting pain and disability, known as chronic whiplash-associated disorder (WAD), may develop after a forced flexion...

  5. Neck collar, "act-as-usual" or active mobilization for whiplash injury? A randomized parallel-group trial

    DEFF Research Database (Denmark)

    Kongsted, Alice; Montvilas, Erisela Qerama; Kasch, Helge

    2007-01-01

    Study Design. Randomized, parallel-group trial. Objective. To compare the effect of 3 early intervention strategies following whiplash injury. Summary of Background Data. Long-lasting pain and disability, known as chronic whiplash-associated disorder (WAD), may develop after a forced flexion......-extension trauma to the cervical spine. It is unclear whether this, in some cases disabling, condition can be prevented by early intervention. Active interventions have been recommended but have not been compared with information only. Methods. Participants were recruited from emergency units and general...... practitioners within 10 days after a whiplash injury and randomized to: 1) immobilization of the cervical spine in a rigid collar followed by active mobilization, 2) advice to "act-as-usual," or 3) an active mobilization program (Mechanical Diagnosis and Therapy). Follow-up was carried out after 3, 6, and 12...

  6. Effectiveness of a mobile cooperation intervention during the clinical practicum of nursing students: a parallel group randomized controlled trial protocol.

    Science.gov (United States)

    Strandell-Laine, Camilla; Saarikoski, Mikko; Löyttyniemi, Eliisa; Salminen, Leena; Suomi, Reima; Leino-Kilpi, Helena

    2017-06-01

    The aim of this study was to describe a study protocol for a study evaluating the effectiveness of a mobile cooperation intervention to improve students' competence level, self-efficacy in clinical performance and satisfaction with the clinical learning environment. Nursing student-nurse teacher cooperation during the clinical practicum has a vital role in promoting the learning of students. Despite an increasing interest in using mobile technologies to improve the clinical practicum of students, there is limited robust evidence regarding their effectiveness. A multicentre, parallel group, randomized, controlled, pragmatic, superiority trial. Second-year pre-registration nursing students who are beginning a clinical practicum will be recruited from one university of applied sciences. Eligible students will be randomly allocated to either a control group (engaging in standard cooperation) or an intervention group (engaging in mobile cooperation) for the 5-week the clinical practicum. The complex mobile cooperation intervention comprises of a mobile application-assisted, nursing student-nurse teacher cooperation and a training in the functions of the mobile application. The primary outcome is competence. The secondary outcomes include self-efficacy in clinical performance and satisfaction with the clinical learning environment. Moreover, a process evaluation will be undertaken. The ethical approval for this study was obtained in December 2014 and the study received funding in 2015. The results of this study will provide robust evidence on mobile cooperation during the clinical practicum, a research topic that has not been consistently studied to date. © 2016 John Wiley & Sons Ltd.

  7. Oral sumatriptan for migraine in children and adolescents: a randomized, multicenter, placebo-controlled, parallel group study.

    Science.gov (United States)

    Fujita, Mitsue; Sato, Katsuaki; Nishioka, Hiroshi; Sakai, Fumihiko

    2014-04-01

    The objective of this article is to evaluate the efficacy and tolerability of two doses of oral sumatriptan vs placebo in the acute treatment of migraine in children and adolescents. Currently, there is no approved prescription medication in Japan for the treatment of migraine in children and adolescents. This was a multicenter, outpatient, single-attack, double-blind, randomized, placebo-controlled, parallel-group study. Eligible patients were children and adolescents aged 10 to 17 years diagnosed with migraine with or without aura (ICHD-II criteria 1.1 or 1.2) from 17 centers. They were randomized to receive sumatriptan 25 mg, 50 mg or placebo (1:1:2). The primary efficacy endpoint was headache relief by two grades on a five-grade scale at two hours post-dose. A total of 178 patients from 17 centers in Japan were enrolled and randomized to an investigational product in double-blind fashion. Of these, 144 patients self-treated a single migraine attack, and all provided a post-dose efficacy assessment and completed the study. The percentage of patients in the full analysis set (FAS) population who report pain relief at two hours post-treatment for the primary endpoint was higher in the placebo group than in the pooled sumatriptan group (38.6% vs 31.1%, 95% CI: -23.02 to 8.04, P  = 0.345). The percentage of patients in the FAS population who reported pain relief at four hours post-dose was higher in the pooled sumatriptan group (63.5%) than in the placebo group (51.4%) but failed to achieve statistical significance ( P  = 0.142). At four hours post-dose, percentages of patients who were pain free or had complete relief of photophobia or phonophobia were numerically higher in the sumatriptan pooled group compared to placebo. Both doses of oral sumatriptan were well tolerated. No adverse events (AEs) were serious or led to study withdrawal. The most common AEs were somnolence in 6% (two patients) in the sumatriptan 25 mg treatment group and chest

  8. Novel Three-Day, Community-Based, Nonpharmacological Group Intervention for Chronic Musculoskeletal Pain (COPERS: A Randomised Clinical Trial.

    Directory of Open Access Journals (Sweden)

    Stephanie J C Taylor

    2016-06-01

    Full Text Available Chronic musculoskeletal pain is the leading cause of disability worldwide. The effectiveness of pharmacological treatments for chronic pain is often limited, and there is growing concern about the adverse effects of these treatments, including opioid dependence. Nonpharmacological approaches to chronic pain may be an attractive alternative or adjunctive treatment. We describe the effectiveness of a novel, theoretically based group pain management support intervention for chronic musculoskeletal pain.We conducted a multi-centre, pragmatic, randomised, controlled effectiveness and cost-effectiveness (cost-utility trial across 27 general practices and community musculoskeletal services in the UK. We recruited 703 adults with musculoskeletal pain of at least 3 mo duration between August 1, 2011, and July 31, 2012, and randomised participants 1.33:1 to intervention (403 or control (300. Intervention participants were offered a participative group intervention (COPERS delivered over three alternate days with a follow-up session at 2 wk. The intervention introduced cognitive behavioural approaches and was designed to promote self-efficacy to manage chronic pain. Controls received usual care and a relaxation CD. The primary outcome was pain-related disability at 12 mo (Chronic Pain Grade [CPG] disability subscale; secondary outcomes included the CPG disability subscale at 6 mo and the following measured at 6 and 12 mo: anxiety and depression (Hospital Anxiety and Depression Scale [HADS], pain acceptance (Chronic Pain Acceptance Questionnaire, social integration (Health Education Impact Questionnaire social integration and support subscale, pain-related self-efficacy (Pain Self-Efficacy Questionnaire, pain intensity (CPG pain intensity subscale, the census global health question (2011 census for England and Wales, health utility (EQ-5D-3L, and health care resource use. Analyses followed the intention-to-treat principle, accounted for clustering by course

  9. 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,

  10. Pharmacokinetics of serelaxin in patients with hepatic impairment: a single-dose, open-label, parallel group study.

    Science.gov (United States)

    Kobalava, Zhanna; Villevalde, Svetlana; Kotovskaya, Yulia; Hinrichsen, Holger; Petersen-Sylla, Marc; Zaehringer, Andreas; Pang, Yinuo; Rajman, Iris; Canadi, Jasna; Dahlke, Marion; Lloyd, Peter; Halabi, Atef

    2015-06-01

    Serelaxin is a recombinant form of human relaxin-2 in development for treatment of acute heart failure. This study aimed to evaluate the pharmacokinetics (PK) of serelaxin in patients with hepatic impairment. Secondary objectives included evaluation of immunogenicity, safety and tolerability of serelaxin. This was an open-label, parallel group study (NCT01433458) comparing the PK of serelaxin following a single 24 h intravenous (i.v.) infusion (30 μg kg(-1)  day(-1) ) between patients with mild, moderate or severe hepatic impairment (Child-Pugh class A, B, C) and healthy matched controls. Blood sampling and standard safety assessments were conducted. Primary non-compartmental PK parameters [including area under the serum concentration-time curve AUC(0-48 h) and AUC(0-∞) and serum concentration at 24 h post-dose (C24h )] were compared between each hepatic impairment group and healthy controls. A total of 49 subjects (including 25 patients with hepatic impairment) were enrolled, of which 48 subjects completed the study. In all groups, the serum concentration of serelaxin increased over the first few hours of infusion, reached steady-state at 12-24 h and then declined following completion of infusion, with a mean terminal half-life of 7-8 h. All PK parameter estimates were comparable between each group of patients with hepatic impairment and healthy controls. No serious adverse events, discontinuations due to adverse events or deaths were reported. No serelaxin treatment-related antibodies developed during this study. The PK and safety profile of serelaxin were not affected by hepatic impairment. No dose adjustment is needed for serelaxin treatment of 48 h i.v. infusion in patients with hepatic impairment. © 2014 The British Pharmacological Society.

  11. 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

  12. 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

  13. A pragmatic, phase III, multisite, double-blind, placebo-controlled, parallel-arm, dose increment randomised trial of regular, low-dose extended-release morphine for chronic breathlessness: Breathlessness, Exertion And Morphine Sulfate (BEAMS) study protocol.

    Science.gov (United States)

    Currow, David; Watts, Gareth John; Johnson, Miriam; McDonald, Christine F; Miners, John O; Somogyi, Andrew A; Denehy, Linda; McCaffrey, Nicola; Eckert, Danny J; McCloud, Philip; Louw, Sandra; Lam, Lawrence; Greene, Aine; Fazekas, Belinda; Clark, Katherine C; Fong, Kwun; Agar, Meera R; Joshi, Rohit; Kilbreath, Sharon; Ferreira, Diana; Ekström, Magnus

    2017-07-17

    Chronic breathlessness is highly prevalent and distressing to patients and families. No medication is registered for its symptomatic reduction. The strongest evidence is for regular, low-dose, extended- release (ER) oral morphine. A recent large phase III study suggests the subgroup most likely to benefit have chronic obstructive pulmonary disease (COPD) and modified Medical Research Council breathlessness scores of 3 or 4. This protocol is for an adequately powered, parallel-arm, placebo-controlled, multisite, factorial, block-randomised study evaluating regular ER morphine for chronic breathlessness in people with COPD. The primary question is what effect regular ER morphine has on worst breathlessness, measured daily on a 0-10 numerical rating scale. Uniquely, the coprimary outcome will use a FitBit to measure habitual physical activity. Secondary questions include safety and, whether upward titration after initial benefit delivers greater net symptom reduction. Substudies include longitudinal driving simulation, sleep, caregiver, health economic and pharmacogenetic studies. Seventeen centres will recruit 171 participants from respiratory and palliative care. The study has five phases including three randomisation phases to increasing doses of ER morphine. All participants will receive placebo or active laxatives as appropriate. Appropriate statistical analysis of primary and secondary outcomes will be used. Ethics approval has been obtained. Results of the study will be submitted for publication in peer-reviewed journals, findings presented at relevant conferences and potentially used to inform registration of ER morphine for chronic breathlessness. NCT02720822; Pre-results. © 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.

  14. Use of bibloc and monobloc oral appliances in obstructive sleep apnoea: a multicentre, randomized, blinded, parallel-group equivalence trial.

    Science.gov (United States)

    Isacsson, Göran; Nohlert, Eva; Fransson, Anette M C; Bornefalk-Hermansson, Anna; Wiman Eriksson, Eva; Ortlieb, Eva; Trepp, Livia; Avdelius, Anna; Sturebrand, Magnus; Fodor, Clara; List, Thomas; Schumann, Mohamad; Tegelberg, Åke

    2018-05-16

    The clinical benefit of bibloc over monobloc appliances in treating obstructive sleep apnoea (OSA) has not been evaluated in randomized trials. We hypothesized that the two types of appliances are equally effective in treating OSA. To compare the efficacy of monobloc versus bibloc appliances in a short-term perspective. In this multicentre, randomized, blinded, controlled, parallel-group equivalence trial, patients with OSA were randomly assigned to use either a bibloc or a monobloc appliance. One-night respiratory polygraphy without respiratory support was performed at baseline, and participants were re-examined with the appliance in place at short-term follow-up. The primary outcome was the change in the apnoea-hypopnea index (AHI). An independent person prepared a randomization list and sealed envelopes. Evaluating dentist and the biomedical analysts who evaluated the polygraphy were blinded to the choice of therapy. Of 302 patients, 146 were randomly assigned to use the bibloc and 156 the monobloc device; 123 and 139 patients, respectively, were analysed as per protocol. The mean changes in AHI were -13.8 (95% confidence interval -16.1 to -11.5) in the bibloc group and -12.5 (-14.8 to -10.3) in the monobloc group. The difference of -1.3 (-4.5 to 1.9) was significant within the equivalence interval (P = 0.011; the greater of the two P values) and was confirmed by the intention-to-treat analysis (P = 0.001). The adverse events were of mild character and were experienced by similar percentages of patients in both groups (39 and 40 per cent for the bibloc and monobloc group, respectively). The study shows short-term results with a median time from commencing treatment to the evaluation visit of 56 days and long-term data on efficacy and harm are needed to be fully conclusive. In a short-term perspective, both appliances were equivalent in terms of their positive effects for treating OSA and caused adverse events of similar magnitude. Registered with Clinical

  15. Efficacy and tolerability of topical sertaconazole versus topical terbinafine in localized dermatophytosis: A randomized, observer-blind, parallel group study.

    Science.gov (United States)

    Chatterjee, Dattatreyo; Ghosh, Sudip Kumar; Sen, Sukanta; Sarkar, Saswati; Hazra, Avijit; De, Radharaman

    2016-01-01

    Epidermal dermatophyte infections most commonly manifest as tinea corporis or tinea cruris. Topical azole antifungals are commonly used in their treatment but literature suggests that most require twice-daily application and provide lower cure rates than the allylamine antifungal terbinafine. We conducted a head-to-head comparison of the effectiveness of the once-daily topical azole, sertaconazole, with terbinafine in these infections. We conducted a randomized, observer-blind, parallel group study (Clinical Trial Registry India [CTRI]/2014/09/005029) with adult patients of either sex presenting with localized lesions. The clinical diagnosis was confirmed by potassium hydroxide smear microscopy of skin scrapings. After baseline assessment of erythema, scaling, and pruritus, patients applied either of the two study drugs once daily for 2 weeks. If clinical cure was not seen at 2 weeks, but improvement was noted, application was continued for further 2 weeks. Patients deemed to be clinical failure at 2 weeks were switched to oral antifungals. Overall 88 patients on sertaconazole and 91 on terbinafine were analyzed. At 2 weeks, the clinical cure rates were comparable at 77.27% (95% confidence interval [CI]: 68.52%-86.03%) for sertaconazole and 73.63% (95% CI 64.57%-82.68%) for terbinafine ( P = 0.606). Fourteen patients in either group improved and on further treatment showed complete healing by another 2 weeks. The final cure rate at 4 weeks was also comparable at 93.18% (95% CI 88.75%-97.62%) and 89.01% (95% CI 82.59%-95.44%), respectively ( P = 0.914). At 2 weeks, 6 (6.82%) sertaconazole and 10 (10.99%) terbinafine recipients were considered as "clinical failure." Tolerability of both preparations was excellent. Despite the limitations of an observer-blind study without microbiological support, the results suggest that once-daily topical sertaconazole is as effective as terbinafine in localized tinea infections.

  16. Intranasal Midazolam versus Rectal Diazepam for the Management of Canine Status Epilepticus: A Multicenter Randomized Parallel-Group Clinical Trial.

    Science.gov (United States)

    Charalambous, M; Bhatti, S F M; Van Ham, L; Platt, S; Jeffery, N D; Tipold, A; Siedenburg, J; Volk, H A; Hasegawa, D; Gallucci, A; Gandini, G; Musteata, M; Ives, E; Vanhaesebrouck, A E

    2017-07-01

    Intranasal administration of benzodiazepines has shown superiority over rectal administration for terminating emergency epileptic seizures in human trials. No such clinical trials have been performed in dogs. To evaluate the clinical efficacy of intranasal midazolam (IN-MDZ), via a mucosal atomization device, as a first-line management option for canine status epilepticus and compare it to rectal administration of diazepam (R-DZP) for controlling status epilepticus before intravenous access is available. Client-owned dogs with idiopathic or structural epilepsy manifesting status epilepticus within a hospital environment were used. Dogs were randomly allocated to treatment with IN-MDZ (n = 20) or R-DZP (n = 15). Randomized parallel-group clinical trial. Seizure cessation time and adverse effects were recorded. For each dog, treatment was considered successful if the seizure ceased within 5 minutes and did not recur within 10 minutes after administration. The 95% confidence interval was used to detect the true population of dogs that were successfully treated. The Fisher's 2-tailed exact test was used to compare the 2 groups, and the results were considered statistically significant if P status epilepticus in 70% (14/20) and 20% (3/15) of cases, respectively (P = .0059). All dogs showed sedation and ataxia. IN-MDZ is a quick, safe and effective first-line medication for controlling status epilepticus in dogs and appears superior to R-DZP. IN-MDZ might be a valuable treatment option when intravenous access is not available and for treatment of status epilepticus in dogs at home. Copyright © 2017 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

  17. Roflumilast for the treatment of COPD in an Asian population: a randomized, double-blind, parallel-group study.

    Science.gov (United States)

    Zheng, Jinping; Yang, Jinghua; Zhou, Xiangdong; Zhao, Li; Hui, Fuxin; Wang, Haoyan; Bai, Chunxue; Chen, Ping; Li, Huiping; Kang, Jian; Brose, Manja; Richard, Frank; Goehring, Udo-Michael; Zhong, Nanshan

    2014-01-01

    Roflumilast is the only oral phosphodiesterase 4 inhibitor indicated for use in the treatment of COPD. Previous studies of roflumilast have predominantly involved European and North American populations. A large study was necessary to determine the efficacy and safety of roflumilast in a predominantly ethnic Chinese population. In a placebo-controlled, double-blind, parallel-group, multicenter, phase 3 study, patients of Chinese, Malay, and Indian ethnicity (N = 626) with severe to very severe COPD were randomized 1:1 to receive either roflumilast 500 μg once daily or placebo for 24 weeks. The primary end point was change in prebronchodilator FEV1 from baseline to study end. Three hundred thirteen patients were assigned to each treatment. Roflumilast provided a sustained increase over placebo in mean prebronchodilator FEV1 (0.071 L; 95% CI, 0.046, 0.095 L; P < .0001). Similar improvements were observed in the secondary end points of postbronchodilator FEV1 (0.068 L; 95% CI 0.044, 0.092 L; P < .0001) and prebronchodilator and postbronchodilator FVC (0.109 L; 95% CI, 0.061, 0.157 L; P < .0001 and 0.101 L; 95% CI, 0.055, 0.146 L; P < .0001, respectively). The adverse event profile was consistent with previous roflumilast studies. The most frequently reported treatment-related adverse event was diarrhea (6.0% and 1.0% of patients in the roflumilast and placebo groups, respectively). Roflumilast plays an important role in lung function improvement and is well tolerated in an Asian population. It provides an optimal treatment choice for patients with severe to very severe COPD.

  18. Neurofeedback, sham neurofeedback, and cognitive-behavioural group therapy in adults with attention-deficit hyperactivity disorder: a triple-blind, randomised, controlled trial.

    Science.gov (United States)

    Schönenberg, Michael; Wiedemann, Eva; Schneidt, Alexander; Scheeff, Jonathan; Logemann, Alexander; Keune, Philipp M; Hautzinger, Martin

    2017-09-01

    Many studies suggest that electroencephalographic (EEG) neurofeedback might be beneficial in the treatment of attention-deficit hyperactivity disorder (ADHD). However, numbers of well controlled studies are low and neurofeedback techniques are regarded as highly controversial. The present trial examined the efficacy (compared with sham neurofeedback) and efficiency (compared with meta-cognitive therapy) of a standard EEG neurofeedback protocol in adults with ADHD. We did a concurrent, triple-blind, randomised, controlled trial using authorised deception in adults with ADHD from one centre (University of Tübingen) in Tübingen, Germany. Participants were eligible if they fulfilled the DSM-IV-TR criteria for ADHD, were aged between 18 years and 60 years, and had no or stable use of medication for at least 2 months with no intention to change. We excluded participants who had comorbid schizophrenia or schizoaffective disorder, bipolar disorder, borderline personality disorder, epilepsy, or traumatic brain injury; substance abuse or dependence; or current or planned other psychological treatment. Those eligible were randomly assigned to three groups: a neurofeedback group which received 30 verum θ-to-β neurofeedback sessions over 15 weeks, a sham neurofeedback group which received 15 sham followed by 15 verum θ-to-β neurofeedback sessions over 15 weeks, or a meta-cognitive group therapy group which received 12 sessions over 12 weeks. Participants were assigned equally to one of the three interventions through a computerised minimisation randomisation procedure stratified by sex, age, and baseline symptom severity of ADHD. Participants were masked as to whether they were receiving neurofeedback or sham neurofeedback, but those receiving meta-cognitive therapy were aware of their treatment. Clinical assessors (ie, those assessing outcomes) and research staff who did the neurofeedback training were masked to participants' randomisation status only for neurofeedback

  19. The effect of group-based exercise on cognitive performance and mood in seniors residing in intermediate care and self-care retirement facilities: a randomised controlled trial.

    Science.gov (United States)

    Brown, A K; Liu-Ambrose, T; Tate, R; Lord, S R

    2009-08-01

    To determine the effect of a general group-based exercise programme on cognitive performance and mood among seniors without dementia living in retirement villages. Randomised controlled trial. Four intermediate care and four self-care retirement village sites in Sydney, Australia. 154 seniors (19 men, 135 women; age range 62 to 95 years), who were residents of intermediate care and self-care retirement facilities. Participants were randomised to one of three experimental groups: (1) a general group-based exercise (GE) programme composed of resistance training and balance training exercises; (2) a flexibility exercise and relaxation technique (FR) programme; or (3) no-exercise control (NEC). The intervention groups (GE and FR) participated in 1-hour exercise classes twice a week for a total period of 6 months. Using standard neuropsychological tests, we assessed cognitive performance at baseline and at 6-month re-test in three domains: (1) fluid intelligence; (2) visual, verbal and working memory; and (3) executive functioning. We also assessed mood using the Geriatric Depression Scale (GDS) and the Positive and Negative Affect Schedule (PANAS). The GE programme significantly improved cognitive performance of fluid intelligence compared with FR or NEC. There were also significant improvements in the positive PANAS scale within both the GE and FR groups and an indication that the two exercise programmes reduced depression in those with initially high GDS scores. Our GE programme significantly improved cognitive performance of fluid intelligence in seniors residing in retirement villages compared with our FR programme and the NEC group. Furthermore, both group-based exercise programmes were beneficial for certain aspects of mood within the 6-month intervention period.

  20. Peer support for family carers of people with dementia, alone or in combination with group reminiscence in a factorial design: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Wenborn Jennifer

    2011-09-01

    Full Text Available Abstract Background Peer support interventions can improve carer wellbeing and interventions that engage both the carer and person with dementia can have significant mutual benefits. Existing research has been criticised for inadequate rigour of design or reporting. This paper describes the protocol for a complex trial that evaluates one-to-one peer support and a group reminiscence programme, both separately and together, in a factorial design. Design A 2 × 2 factorial multi-site randomised controlled trial of individual peer support and group reminiscence interventions for family carers and people with dementia in community settings in England, addressing both effectiveness and cost-effectiveness. Discussion The methods described in this protocol have implications for research into psychosocial interventions, particularly complex interventions seeking to test both individual and group approaches. Trial Registration ISRCTN37956201

  1. Psychological effects of belonging to a Facebook weight management group in overweight and obese adults: Results of a randomised controlled trial.

    Science.gov (United States)

    Jane, Monica; Foster, Jonathan; Hagger, Martin; Ho, Suleen; Kane, Robert; Pal, Sebely

    2018-05-18

    This study was conducted to test whether the weight outcomes in an online social networking group were mediated by changes to psychological outcome measures in overweight and obese individuals, following a weight management programme delivered via Facebook. The data analysed in this study were collected during a three-armed, randomised, controlled clinical weight management trial conducted with overweight and obese adults over 24 weeks. Two intervention groups were given the same weight management programme: one within a Facebook group, along with peer support from other group members (the Facebook Group); the other group received the same programme in a pamphlet (the Pamphlet Group). A Control Group was given standard care. The primary outcome was weight; secondary outcomes included the following domains from self-reported questionnaires: energy intake and expenditure; psychological health, social relationships, physical health, quality of life, depression, anxiety, stress, health anxiety, happiness, as well as Facebook Group participants' opinion of this group. The Facebook Group experienced a reduction in their baseline weight measurement by week 24, significantly compared to the Control Group (p = .016). The Facebook Group recorded a significant increase in the psychological health domain during the trial (at week 12) relative to their baseline measurement, and significant compared to the Control Group (p = .022). Mediation analysis indicated a statistical trend, but not statistical significance, for psychological health as a mediator to weight loss in the Facebook Group. While both intervention groups showed significant changes in psychological outcome measures, the Facebook Group was the only group to experience statistically significant weight loss by the end of the 24 weeks. Therefore, an examination of other psychological and/or behavioural outcome measures undertaken in larger studies in the future may help to identify significant mediators to

  2. 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

  3. Weight Loss Maintenance for 2 Years after a 6-Month Randomised Controlled Trial Comparing Education-Only and Group-Based Support in Japanese Adults

    Directory of Open Access Journals (Sweden)

    Yoshio Nakata

    2014-11-01

    Full Text Available Objective: Our previous study, a 6-month randomised controlled trial, demonstrated that a group-based support promoted weight loss as compared to an education-only intervention. The purpose of this study was to examine weight loss maintenance for 2 years. Methods: Originally, 188 overweight Japanese adults, aged 40-65 years, were randomly assigned to 3 groups: control, education-only or group-based support. After the 6-month intervention, 125 participants in the education-only and the group-based support groups were followed up for 2 years. The primary outcome was the amount of weight lost. The participants were retrospectively grouped into quartiles of percent weight loss for secondary analyses. Results: At the end of follow-up, the amount of weight lost in the education-only and the group-based support groups was the same (3.3 kg. Secondary analyses using data of those who completed the study (n = 100 revealed that the participants in the highest quartile of percent weight loss significantly increased their step counts and moderate-to-vigorous physical activity compared with the lowest quartile. No significant differences were observed in the energy intake among the four groups. Conclusion: The effects of group-based support disappear within 2 years. Increasing physical activity may be a crucial factor for successful maintenance of weight loss.

  4. Targets and self-management for the control of blood pressure in stroke and at risk groups (TASMIN-SR): protocol for a randomised controlled trial.

    Science.gov (United States)

    O'Brien, Claire; Bray, Emma P; Bryan, Stirling; Greenfield, Sheila M; Haque, M Sayeed; Hobbs, F D Richard; Jones, Miren I; Jowett, Sue; Kaambwa, Billingsley; Little, Paul; Mant, Jonathan; Penaloza, Cristina; Schwartz, Claire; Shackleford, Helen; Varghese, Jinu; Williams, Bryan; McManus, Richard J

    2013-03-23

    Self-monitoring of hypertension with self-titration of antihypertensives (self-management) results in lower systolic blood pressure for at least one year. However, few people in high risk groups have been evaluated to date and previous work suggests a smaller effect size in these groups. This trial therefore aims to assess the added value of self-management in high risk groups over and above usual care. The targets and self-management for the control of blood pressure in stroke and at risk groups (TASMIN-SR) trial will be a pragmatic primary care based, unblinded, randomised controlled trial of self-management of blood pressure (BP) compared to usual care. Eligible patients will have a history of stroke, coronary heart disease, diabetes or chronic kidney disease and will be recruited from primary care. Participants will be individually randomised to either usual care or self-management. The primary outcome of the trial will be difference in office SBP between intervention and control groups at 12 months adjusted for baseline SBP and covariates. 540 patients will be sufficient to detect a difference in SBP between self-management and usual care of 5 mmHg with 90% power. Secondary outcomes will include self-efficacy, lifestyle behaviours, health-related quality of life and adverse events. An economic analysis will consider both within trial costs and a model extrapolating the results thereafter. A qualitative analysis will gain insights into patients' views, experiences and decision making processes. The results of the trial will be directly applicable to primary care in the UK. If successful, self-management of blood pressure in people with stroke and other high risk conditions would be applicable to many hundreds of thousands of individuals in the UK and beyond. ISRCTN87171227.

  5. Hemostatic efficacy of TachoSil in liver resection compared with argon beam coagulator treatment: An open, randomized, prospective, multicenter, parallel-group trial

    DEFF Research Database (Denmark)

    Fischer, Lars; Seiler, Christoph M.; Broelsch, Christoph E.

    2011-01-01

    surgical trial with 2 parallel groups. Patients were eligible for intra-operative randomization after elective resection of ≥1 liver segment and primary hemostasis. The primary end point was the time to hemostasis after starting the randomized intervention to obtain secondaty hemostasis. Secondary end...

  6. Acupuncture treatment for pain: systematic review of randomised clinical trials with acupuncture, placebo acupuncture, and no acupuncture groups

    DEFF Research Database (Denmark)

    Madsen, Matias Vested; Gøtzsche, Peter C; Hróbjartsson, Asbjørn

    2009-01-01

    OBJECTIVES: To study the analgesic effect of acupuncture and placebo acupuncture and to explore whether the type of the placebo acupuncture is associated with the estimated effect of acupuncture. DESIGN: Systematic review and meta-analysis of three armed randomised clinical trials. DATA SOURCES......: Cochrane Library, Medline, Embase, Biological Abstracts, and PsycLIT. Data extraction and analysis Standardised mean differences from each trial were used to estimate the effect of acupuncture and placebo acupuncture. The different types of placebo acupuncture were ranked from 1 to 5 according...... to assessment of the possibility of a physiological effect, and this ranking was meta-regressed with the effect of acupuncture. DATA SYNTHESIS: Thirteen trials (3025 patients) involving a variety of pain conditions were eligible. The allocation of patients was adequately concealed in eight trials...

  7. Online group-based cognitive-behavioural therapy for adolescents and young adults after cancer treatment: a multicenter randomised controlled trial of Recapture Life-AYA.

    Science.gov (United States)

    Sansom-Daly, Ursula M; Wakefield, Claire E; Bryant, Richard A; Butow, Phyllis; Sawyer, Susan; Patterson, Pandora; Anazodo, Antoinette; Thompson, Kate; Cohn, Richard J

    2012-08-03

    A cancer diagnosis is 2.9 times more likely to occur during the adolescent and young adult years than in younger children. This spike in incidence coincides with a life stage characterised by psychological vulnerability as young people strive to attain numerous, critical developmental milestones. The distress young people experience after cancer treatment seriously jeopardises their ability to move into well-functioning adulthood. This article presents the protocol of the Recapture Life study, a phase II three-arm randomised controlled trial designed to evaluate the feasibility and efficacy of a new intervention in reducing distress and improving quality of life for adolescent and young adult cancer survivors. The novel intervention, "ReCaPTure LiFe" will be compared to a both a wait-list, and a peer-support group control. Ninety young people aged 15-25 years who have completed cancer treatment in the past 1-6 months will be recruited from hospitals around Australia. Those randomised to receive Recapture Life will participate in six, weekly, 90-minute online group sessions led by a psychologist, involving peer-discussion around cognitive-behavioural coping skills (including: behavioural activation, thought challenging, communication and assertiveness skills training, problem-solving and goal-setting). Participants randomised to the peer-support group control will receive non-directive peer support delivered in an identical manner. Participants will complete psychosocial measures at baseline, post-intervention, and 12-months post-intervention. The primary outcome will be quality of life. Secondary outcomes will include depression, anxiety, stress, family functioning, coping, and cancer-related identity. This article reviews the empirical rationale for using group-based, online cognitive-behavioural therapy in young people after cancer treatment. The potential challenges of delivering skills-based programs in an online modality are highlighted, and the role of both

  8. Online group-based cognitive-behavioural therapy for adolescents and young adults after cancer treatment: A multicenter randomised controlled trial of Recapture Life-AYA

    Directory of Open Access Journals (Sweden)

    Sansom-Daly Ursula M

    2012-08-01

    Full Text Available Abstract Background A cancer diagnosis is 2.9 times more likely to occur during the adolescent and young adult years than in younger children. This spike in incidence coincides with a life stage characterised by psychological vulnerability as young people strive to attain numerous, critical developmental milestones. The distress young people experience after cancer treatment seriously jeopardises their ability to move into well-functioning adulthood. Methods/Design This article presents the protocol of the Recapture Life study, a phase II three-arm randomised controlled trial designed to evaluate the feasibility and efficacy of a new intervention in reducing distress and improving quality of life for adolescent and young adult cancer survivors. The novel intervention, “ReCaPTure LiFe” will be compared to a both a wait-list, and a peer-support group control. Ninety young people aged 15–25 years who have completed cancer treatment in the past 1–6 months will be recruited from hospitals around Australia. Those randomised to receive Recapture Life will participate in six, weekly, 90-minute online group sessions led by a psychologist, involving peer-discussion around cognitive-behavioural coping skills (including: behavioural activation, thought challenging, communication and assertiveness skills training, problem-solving and goal-setting. Participants randomised to the peer-support group control will receive non-directive peer support delivered in an identical manner. Participants will complete psychosocial measures at baseline, post-intervention, and 12-months post-intervention. The primary outcome will be quality of life. Secondary outcomes will include depression, anxiety, stress, family functioning, coping, and cancer-related identity. Discussion This article reviews the empirical rationale for using group-based, online cognitive-behavioural therapy in young people after cancer treatment. The potential challenges of delivering skills

  9. Moderating factors for the effectiveness of group art therapy for schizophrenia: secondary analysis of data from the MATISSE randomised controlled trial.

    Science.gov (United States)

    Leurent, Baptiste; Killaspy, Helen; Osborn, David P; Crawford, Mike J; Hoadley, Angela; Waller, Diane; King, Michael

    2014-11-01

    Although some studies suggest that art therapy may be useful in the treatment of negative symptoms of schizophrenia, a recent large trial of group art therapy found no clinical advantage over standard care, but the study population was heterogeneous and uptake of the intervention was poor. This study aimed to investigate whether art therapy was more effective for specific subgroups of patients. Secondary analysis of data from a randomised controlled trial of group art therapy as an adjunctive treatment for schizophrenia (n = 140) versus standard care alone (n = 137). Positive and Negative Syndrome Scale scores at 12 months were compared between trial arms. Interaction between intervention effect and different subgroups, including those with more severe negative symptoms of schizophrenia, and those who expressed a preference for art therapy prior to randomisation, was tested using a linear mixed model. The clinical effectiveness of group art therapy did not significantly differ between participants with more or less severe negative symptoms [interaction for difference in PANSS = 1.7, 95 % CI (-8.6 to 12.1), P = 0.741], or between those who did and did not express a preference for art therapy [interaction = 3.9, 95 % CI (-6.7 to 14.5), P = 0.473]. None of the other exploratory subgroups suggested differences in intervention effect. There was no evidence of greater improvement in clinical symptoms of schizophrenia for those with more severe negative symptoms or those with a preference for art therapy. Identification of patients with schizophrenia who may benefit most from group art therapy remains elusive.

  10. Performance of a fine-grained parallel model for multi-group nodal-transport calculations in three-dimensional pin-by-pin reactor geometry

    International Nuclear Information System (INIS)

    Masahiro, Tatsumi; Akio, Yamamoto

    2003-01-01

    A production code SCOPE2 was developed based on the fine-grained parallel algorithm by the red/black iterative method targeting parallel computing environments such as a PC-cluster. It can perform a depletion calculation in a few hours using a PC-cluster with the model based on a 9-group nodal-SP3 transport method in 3-dimensional pin-by-pin geometry for in-core fuel management of commercial PWRs. The present algorithm guarantees the identical convergence process as that in serial execution, which is very important from the viewpoint of quality management. The fine-mesh geometry is constructed by hierarchical decomposition with introduction of intermediate management layer as a block that is a quarter piece of a fuel assembly in radial direction. A combination of a mesh division scheme forcing even meshes on each edge and a latency-hidden communication algorithm provided simplicity and efficiency to message passing to enhance parallel performance. Inter-processor communication and parallel I/O access were realized using the MPI functions. Parallel performance was measured for depletion calculations by the 9-group nodal-SP3 transport method in 3-dimensional pin-by-pin geometry with 340 x 340 x 26 meshes for full core geometry and 170 x 170 x 26 for quarter core geometry. A PC cluster that consists of 24 Pentium-4 processors connected by the Fast Ethernet was used for the performance measurement. Calculations in full core geometry gave better speedups compared to those in quarter core geometry because of larger granularity. Fine-mesh sweep and feedback calculation parts gave almost perfect scalability since granularity is large enough, while 1-group coarse-mesh diffusion acceleration gave only around 80%. The speedup and parallel efficiency for total computation time were 22.6 and 94%, respectively, for the calculation in full core geometry with 24 processors. (authors)

  11. Feasibility and effectiveness of a cognitive remediation programme with original computerised cognitive training and group intervention for schizophrenia: a multicentre randomised trial.

    Science.gov (United States)

    Matsuda, Yasuhiro; Morimoto, Tsubasa; Furukawa, Shunichi; Sato, Sayaka; Hatsuse, Norifumi; Iwata, Kazuhiko; Kimura, Mieko; Kishimoto, Toshifumi; Ikebuchi, Emi

    2018-04-01

    Devising new methods to improve neurocognitive impairment through cognitive remediation is an important research goal. We developed an original computer programme termed the Japanese Cognitive Rehabilitation Programme for Schizophrenia (JCORES) that provides cognitive practice across a broad range of abilities. The current study examined for the first time whether a cognitive remediation programme, including both computerised cognitive training using JCORES and group intervention such as enhancing meta-cognition and teaching strategies, is more effective than treatment as usual for improving neurocognitive and social functioning. Sixty-two outpatients with schizophrenia were randomised to either a cognitive remediation group or a control group. Participants engaged in two computerised cognitive training sessions and one group meeting per week for 12 weeks. The average number of total sessions attended (computerised cognitive practice + group intervention) was 32.3 (89.7%). The cognitive remediation group showed significantly more improvements in verbal memory, composite score of the Brief Assessment of Cognition in Schizophrenia, Japanese version (BACS-J), and general psychopathology on the Positive and Negative Syndrome Scale (PANSS) than the control group. These findings demonstrate that a cognitive remediation programme is feasible in Japan and is a more effective way to improve neurocognitive functioning and psychiatric symptoms.

  12. A prospective, multi-centre, randomised, open label, parallel, comparative study to evaluate effects of AQUACEL(®) Ag and Urgotul(®) Silver dressing on healing of chronic venous leg ulcers

    DEFF Research Database (Denmark)

    Harding, Keith; Gottrup, Finn; Jawień, Arkadiusz

    2011-01-01

    This study compared wound healing efficacy of two silver dressings, AQUACEL(®) Ag and Urgotul(®) Silver, against venous ulcers at risk of infection, over 8 weeks of treatment. The primary objective was to show non inferiority of AQUACEL(®) Ag to Urgotul(®) Silver. Patients (281) were randomised......, safety events and ulcer healing were compared. After 8 weeks of treatment, the AQUACEL(®) Ag group had a relative wound size reduction (49·65% ± 52·53%) compared with the Urgotul(®) Silver group (42·81% ± 60·0%). The non inferiority of the AQUACEL(®) Ag group to the Urgotul(®) Silver group...... was established based on the difference between them (6·84% ± 56·3%, 95% confidence interval -6·56 to 20·2) and the pre-defined non inferiority margin (-15%). Composite wound healing analysis showed that the AQUACEL(®) Ag group had statistically higher percentage of subjects with better wound progression (66...

  13. Participatory women's groups and counselling through home visits to improve child growth in rural eastern India: protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Nair, Nirmala; Tripathy, Prasanta; Sachdev, Harshpal S; Bhattacharyya, Sanghita; Gope, Rajkumar; Gagrai, Sumitra; Rath, Shibanand; Rath, Suchitra; Sinha, Rajesh; Roy, Swati Sarbani; Shewale, Suhas; Singh, Vijay; Srivastava, Aradhana; Pradhan, Hemanta; Costello, Anthony; Copas, Andrew; Skordis-Worrall, Jolene; Haghparast-Bidgoli, Hassan; Saville, Naomi; Prost, Audrey

    2015-04-15

    Child stunting (low height-for-age) is a marker of chronic undernutrition and predicts children's subsequent physical and cognitive development. Around one third of the world's stunted children live in India. Our study aims to assess the impact, cost-effectiveness, and scalability of a community intervention with a government-proposed community-based worker to improve growth in children under two in rural India. The study is a cluster randomised controlled trial in two rural districts of Jharkhand and Odisha (eastern India). The intervention tested involves a community-based worker carrying out two activities: (a) one home visit to all pregnant women in the third trimester, followed by subsequent monthly home visits to all infants aged 0-24 months to support appropriate feeding, infection control, and care-giving; (b) a monthly women's group meeting using participatory learning and action to catalyse individual and community action for maternal and child health and nutrition. Both intervention and control clusters also receive an intervention to strengthen Village Health Sanitation and Nutrition Committees. The unit of randomisation is a purposively selected cluster of approximately 1000 population. A total of 120 geographical clusters covering an estimated population of 121,531 were randomised to two trial arms: 60 clusters in the intervention arm receive home visits, group meetings, and support to Village Health Sanitation and Nutrition Committees; 60 clusters in the control arm receive support to Committees only. The study participants are pregnant women identified in the third trimester of pregnancy and their children (n = 2520). Mothers and their children are followed up at seven time points: during pregnancy, within 72 hours of delivery, and at 3, 6, 9, 12 and 18 months after birth. The trial's primary outcome is children's mean length-for-age Z scores at 18 months. Secondary outcomes include wasting and underweight at all time points, birth weight, growth

  14. Individual versus interprofessional team performance in formulating care transition plans: A randomised study of trainees from five professional groups.

    Science.gov (United States)

    Farrell, Timothy W; Supiano, Katherine P; Wong, Bob; Luptak, Marilyn K; Luther, Brenda; Andersen, Troy C; Wilson, Rebecca; Wilby, Frances; Yang, Rumei; Pepper, Ginette A; Brunker, Cherie P

    2018-05-01

    Health professions trainees' performance in teams is rarely evaluated, but increasingly important as the healthcare delivery systems in which they will practice move towards team-based care. Effective management of care transitions is an important aspect of interprofessional teamwork. This mixed-methods study used a crossover design to randomise health professions trainees to work as individuals and as teams to formulate written care transition plans. Experienced external raters assessed the quality of the written care transition plans as well as both the quality of team process and overall team performance. Written care transition plan quality did not vary between individuals and teams (21.8 vs. 24.4, respectively, p = 0.42). The quality of team process did not correlate with the quality of the team-generated written care transition plans (r = -0.172, p = 0.659). However, there was a significant correlation between the quality of team process and overall team performance (r = 0.692, p = 0.039). Teams with highly engaged recorders, performing an internal team debrief, had higher-quality care transition plans. These results suggest that high-quality interprofessional care transition plans may require advance instruction as well as teamwork in finalising the plan.

  15. Intensive versus conventional blood pressure monitoring in a general practice population. The Blood Pressure Reduction in Danish General Practice trial: a randomized controlled parallel group trial

    DEFF Research Database (Denmark)

    Klarskov, Pia; Bang, Lia E; Schultz-Larsen, Peter

    2018-01-01

    To compare the effect of a conventional to an intensive blood pressure monitoring regimen on blood pressure in hypertensive patients in the general practice setting. Randomized controlled parallel group trial with 12-month follow-up. One hundred and ten general practices in all regions of Denmark....... One thousand forty-eight patients with essential hypertension. Conventional blood pressure monitoring ('usual group') continued usual ad hoc blood pressure monitoring by office blood pressure measurements, while intensive blood pressure monitoring ('intensive group') supplemented this with frequent...... a reduction of blood pressure. Clinical Trials NCT00244660....

  16. Critical appraisal of arguments for the delayed-start design proposed as alternative to the parallel-group randomized clinical trial design in the field of rare disease.

    Science.gov (United States)

    Spineli, Loukia M; Jenz, Eva; Großhennig, Anika; Koch, Armin

    2017-08-17

    A number of papers have proposed or evaluated the delayed-start design as an alternative to the standard two-arm parallel group randomized clinical trial (RCT) design in the field of rare disease. However the discussion is felt to lack a sufficient degree of consideration devoted to the true virtues of the delayed start design and the implications either in terms of required sample-size, overall information, or interpretation of the estimate in the context of small populations. To evaluate whether there are real advantages of the delayed-start design particularly in terms of overall efficacy and sample size requirements as a proposed alternative to the standard parallel group RCT in the field of rare disease. We used a real-life example to compare the delayed-start design with the standard RCT in terms of sample size requirements. Then, based on three scenarios regarding the development of the treatment effect over time, the advantages, limitations and potential costs of the delayed-start design are discussed. We clarify that delayed-start design is not suitable for drugs that establish an immediate treatment effect, but for drugs with effects developing over time, instead. In addition, the sample size will always increase as an implication for a reduced time on placebo resulting in a decreased treatment effect. A number of papers have repeated well-known arguments to justify the delayed-start design as appropriate alternative to the standard parallel group RCT in the field of rare disease and do not discuss the specific needs of research methodology in this field. The main point is that a limited time on placebo will result in an underestimated treatment effect and, in consequence, in larger sample size requirements compared to those expected under a standard parallel-group design. This also impacts on benefit-risk assessment.

  17. Reaching the poor with health interventions: programme-incidence analysis of seven randomised trials of women's groups to reduce newborn mortality in Asia and Africa.

    Science.gov (United States)

    Houweling, Tanja A J; Morrison, Joanna; Alcock, Glyn; Azad, Kishwar; Das, Sushmita; Hossen, Munir; Kuddus, Abdul; Lewycka, Sonia; Looman, Caspar W; Magar, Bharat Budhathoki; Manandhar, Dharma S; Akter, Mahfuza; Dube, Albert Lazarous Nkhata; Rath, Shibanand; Saville, Naomi; Sen, Aman; Tripathy, Prasanta; Costello, Anthony

    2016-01-01

    Efforts to end preventable newborn deaths will fail if the poor are not reached with effective interventions. To understand what works to reach vulnerable groups, we describe and explain the uptake of a highly effective community-based newborn health intervention across social strata in Asia and Africa. We conducted a secondary analysis of seven randomised trials of participatory women's groups to reduce newborn mortality in India, Bangladesh, Nepal and Malawi. We analysed data on 70,574 pregnancies. Socioeconomic and sociodemographic differences in group attendance were tested using logistic regression. Qualitative data were collected at each trial site (225 focus groups, 20 interviews) to understand our results. Socioeconomic differences in women's group attendance were small, except for occasional lower attendance by elites. Sociodemographic differences were large, with lower attendance by young primigravid women in African as well as in South Asian sites. The intervention was considered relevant and interesting to all socioeconomic groups. Local facilitators ensured inclusion of poorer women. Embarrassment and family constraints on movement outside the home restricted attendance among primigravid women. Reproductive health discussions were perceived as inappropriate for them. Community-based women's groups can help to reach every newborn with effective interventions. Equitable intervention uptake is enhanced when facilitators actively encourage all women to attend, organise meetings at the participants' convenience and use approaches that are easily understandable for the less educated. Focused efforts to include primigravid women are necessary, working with families and communities to decrease social taboos. 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/

  18. Group Music Therapy for Prisoners

    DEFF Research Database (Denmark)

    Chen, Xi Jing; Hannibal, Niels; Xu, Kevin

    2014-01-01

    The prevalence of psychological problems is high in prisons. Many prisoners have unmet needs for appropriate treatments. Although previous studies have suggested music therapy to be a successful treatment modality for prisoners, more rigorous evidence is needed. This parallel randomised controlled...... study aims to investigate the effectiveness of group music therapy to reduce anxiety and depression, and raise self-esteem in prisoners. One hundred and ninety two inmates from a Chinese prison will be allocated to two groups through randomisation. The experimental group will participate in biweekly...... group music therapy for 10 weeks (20 sessions) while the control group will be placed on a waitlist. Anxiety, depression and self-esteem will be measured by self-report scales three times: before, at the middle, and at the end of the intervention. Logs by the participants and their daily routine...

  19. Impulsivity-focused group intervention to reduce binge eating episodes in patients with binge eating disorder: study protocol of the randomised controlled IMPULS trial.

    Science.gov (United States)

    Schag, Kathrin; Leehr, Elisabeth J; Martus, Peter; Bethge, Wolfgang; Becker, Sandra; Zipfel, Stephan; Giel, Katrin E

    2015-12-18

    The core symptom of binge eating disorder (BED) is recurrent binge eating that is accompanied by a sense of loss of control. BED is frequently associated with obesity, one of the main public health challenges today. Experimental studies deliver evidence that general trait impulsivity and disorder-specific food-related impulsivity constitute risk factors for BED. Cognitive-behavioural treatment (CBT) is deemed to be the most effective intervention concerning BED. We developed a group intervention based on CBT and especially focusing on impulsivity. We hypothesise that such an impulsivity-focused group intervention is able to increase control over impulsive eating behaviour, that is, reduce binge eating episodes, further eating pathology and impulsivity. Body weight might also be influenced in the long term. The present randomised controlled trial investigates the feasibility, acceptance and efficacy of this impulsivity-focused group intervention in patients with BED. We compare 39 patients with BED in the experimental group to 39 patients with BED in the control group at three appointments: before and after the group intervention and in a 3-month follow-up. Patients with BED in the experimental group receive 8 weekly sessions of the impulsivity-focused group intervention with 5-6 patients per group. Patients with BED in the control group receive no group intervention. The primary outcome is the binge eating frequency over the past 4 weeks. Secondary outcomes comprise further eating pathology, general impulsivity and food-related impulsivity assessed by eye tracking methodology, and body weight. Additionally, we assess binge eating and other impulsive behaviour weekly in process analyses during the time period of the group intervention. This study has been approved by the ethics committee of the medical faculty of Eberhard Karls University Tübingen and the University Hospital Tübingen. Data are monitored by the Centre of Clinical Studies, University Hospital T

  20. Impact of a participatory intervention with women's groups on psychological distress among mothers in rural Bangladesh: secondary analysis of a cluster-randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Kelly Clarke

    Full Text Available Perinatal common mental disorders (PCMDs are a major cause of disability among women and disproportionately affect lower income countries. Interventions to address PCMDs are urgently needed in these settings, and group-based and peer-led approaches are potential strategies to increase access to mental health interventions. Participatory women's health groups led by local women previously reduced postpartum psychological distress in eastern India. We assessed the effect of a similar intervention on postpartum psychological distress in rural Bangladesh.We conducted a secondary analysis of data from a cluster-randomised controlled trial with 18 clusters and an estimated population of 532,996. Nine clusters received an intervention comprising monthly meetings during which women's groups worked through a participatory learning and action cycle to develop strategies for improving women's and children's health. There was one group for every 309 individuals in the population, 810 groups in total. Mothers in nine control clusters had access to usual perinatal care. Postpartum psychological distress was measured with the 20-item Self Reporting Questionnaire (SRQ-20 between six and 52 weeks after delivery, during the months of January to April, in 2010 and 2011.We analysed outcomes for 6275 mothers. Although the cluster mean SRQ-20 score was lower in the intervention arm (mean 5.2, standard deviation 1.8 compared to control (5.3, 1.2, the difference was not significant (β 1.44, 95% CI 0.28, 3.08.Despite promising results in India, participatory women's groups focused on women's and children's health had no significant effect on postpartum psychological distress in rural Bangladesh.

  1. A school-based intervention to promote physical activity among adolescent girls: Rationale, design, and baseline data from the Girls in Sport group randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Puglisi Lauren

    2011-08-01

    Full Text Available Abstract Background Physical activity levels decline markedly among girls during adolescence. School-based interventions that are multi-component in nature, simultaneously targeting curricular, school environment and policy, and community links, are a promising approach for promoting physical activity. This report describes the rationale, design and baseline data from the Girls in Sport group randomised trial, which aims to prevent the decline in moderate-to-vigorous intensity physical activity (MVPA among adolescent girls. Methods/Design A community-based participatory research approach and action learning framework are used with measurements at baseline and 18-month follow-up. Within each intervention school, a committee develops an action plan aimed at meeting the primary objective (preventing the decline in accelerometer-derived MVPA. Academic partners and the State Department of Education and Training act as critical friends. Control schools continue with their usual school programming. 24 schools were matched then randomized into intervention (n = 12 and control (n = 12 groups. A total of 1518 girls (771 intervention and 747 control completed baseline assessments (86% response rate. Useable accelerometer data (≥10 hrs/day on at least 3 days were obtained from 79% of this sample (n = 1199. Randomisation resulted in no differences between intervention and control groups on any of the outcomes. The mean age (SE of the sample was 13.6 (± 0.02 years and they spent less than 5% of their waking hours in MVPA (4.85 ± 0.06. Discussion Girls in Sport will test the effectiveness of schools working towards the same goal, but developing individual, targeted interventions that bring about changes in curriculum, school environment and policy, and community links. By using community-based participatory research and an action learning framework in a secondary school setting, it aims to add to the body of literature on effective school

  2. An equivalence evaluation of a nurse-moderated group-based internet support program for new mothers versus standard care: a pragmatic preference randomised controlled trial

    Science.gov (United States)

    2014-01-01

    Background All mothers in South Australia are offered a clinic or home-visit by a Child and Family Health community nurse in the initial postnatal weeks. Subsequent support is available on request from staff in community clinics and from a telephone helpline. The aim of the present study is to compare equivalence of a single clinic-based appointment plus a nurse-moderated group-based internet intervention when infants were aged 0–6 months versus a single home-visit together with subsequent standard services (the latter support was available to mothers in both study groups). Methods/Design The evaluation utilised a pragmatic preference randomised trial comparing the equivalence of outcomes for mothers and infants across the two study groups. Eligible mothers were those whose services were provided by nurses working in one of six community clinics in the metropolitan region of Adelaide. Mothers were excluded if they did not have internet access, required an interpreter, or their nurse clinician recommended that they not participate due to issues such as domestic violence or substance abuse. Randomisation was based on the service identification number sequentially assigned to infants when referred to the Child and Family Health Services from birthing units (this was done by administrative staff who had no involvement in recruiting mothers, delivering the intervention, or analyzing results for the study). Consistent with design and power calculations, 819 mothers were recruited to the trial. The primary outcomes for the trial are parents’ sense of competence and self-efficacy measured using standard self-report questionnaires. Secondary outcomes include the quality of mother-infant relationships, maternal social support, role satisfaction and maternal mental health, infant social-emotional and language development, and patterns of service utilisation. Maternal and infant outcomes will be evaluated using age-appropriate questionnaires when infants are aged <2 months

  3. Improving the effectiveness of psychological interventions for depression and anxiety in the cardiac rehabilitation pathway using group-based metacognitive therapy (PATHWAY Group MCT): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Wells, Adrian; McNicol, Kirsten; Reeves, David; Salmon, Peter; Davies, Linda; Heagerty, Anthony; Doherty, Patrick; McPhillips, Rebecca; Anderson, Rebecca; Faija, Cintia; Capobianco, Lora; Morley, Helen; Gaffney, Hannah; Shields, Gemma; Fisher, Peter

    2018-04-03

    Anxiety and depression are prevalent among cardiac rehabilitation patients but pharmacological and psychological treatments have limited effectiveness in this group. Furthermore, psychological interventions have not been systematically integrated into cardiac rehabilitation services despite being a strategic priority for the UK National Health Service. A promising new treatment, metacognitive therapy, may be well-suited to the needs of cardiac rehabilitation patients and has the potential to improve outcomes. It is based on the metacognitive model, which proposes that a thinking style dominated by rumination, worry and threat monitoring maintains emotional distress. Metacognitive therapy is highly effective at reducing this thinking style and alleviating anxiety and depression in mental health settings. This trial aims to evaluate the effectiveness and cost-effectiveness of group-based metacognitive therapy for cardiac rehabilitation patients with elevated anxiety and/or depressive symptoms. The PATHWAY Group-MCT trial is a multicentre, two-arm, single-blind, randomised controlled trial comparing the clinical- and cost-effectiveness of group-based metacognitive therapy plus usual cardiac rehabilitation to usual cardiac rehabilitation alone. Cardiac rehabilitation patients (target sample n = 332) with elevated anxiety and/or depressive symptoms will be recruited across five UK National Health Service Trusts. Participants randomised to the intervention arm will receive six weekly sessions of group-based metacognitive therapy delivered by either cardiac rehabilitation professionals or research nurses. The intervention and control groups will both be offered the usual cardiac rehabilitation programme within their Trust. The primary outcome is severity of anxiety and depressive symptoms at 4-month follow-up measured by the Hospital Anxiety and Depression Scale total score. Secondary outcomes are severity of anxiety/depression at 12-month follow-up, health

  4. Intensive group training protocol versus guideline physiotherapy for patients with chronic low back pain: a randomised controlled trial

    NARCIS (Netherlands)

    van der Roer, N.; van Tulder, M.W.; Barendse, J.; Knol, D.L.; van Mechelen, W.; de Vet, H.C.W.

    2008-01-01

    Intensive group training using principles of graded activity has been proven to be effective in occupational care for workers with chronic low back pain. Objective of the study was to compare the effects of an intensive group training protocol aimed at returning to normal daily activities and

  5. Group cognitive behavioural therapy and weight regain after diet in type 2 diabetes: results from the randomised controlled POWER trial

    NARCIS (Netherlands)

    K.A.C. Berk (Kirsten); H. Buijks (Hanneke); A.J.M. Verhoeven (Adrie); Mulder, M.T. (Monique T.); B. Özcan (Behiye); van ’T Spijker, A. (Adriaan); R. Timman (Reinier); J.J. van Busschbach (Jan); E.J.G. Sijbrands (Eric)

    2018-01-01

    textabstractAims/hypothesis: Weight-loss programmes for adults with type 2 diabetes are less effective in the long term owing to regain of weight. Our aim was to determine the 2 year effectiveness of a cognitive behavioural group therapy (group-CBT) programme in weight maintenance after diet-induced

  6. 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.

  7. Targeting children of substance-using parents with the community-based group intervention TRAMPOLINE: A randomised controlled trial - design, evaluation, recruitment issues

    Science.gov (United States)

    2012-01-01

    Background Children of substance-abusing parents are at risk for developing psychosocial development problems. In Germany it is estimated that approx. 2.65 million children are affected by parental substance abuse or dependence. Only ten percent of them receive treatment when parents are treated. To date, no evaluated programme for children from substance-affected families exists in Germany. The study described in this protocol is designed to test the effectiveness of the group programme TRAMPOLINE for children aged 8-12 years with at least one substance-abusing or -dependent caregiver. The intervention is specifically geared to issues and needs of children from substance-affected families. Methods/Design The effectiveness of the manualised nine-session group programme TRAMPOLINE is tested among N = 218 children from substance-affected families in a multicentre randomised controlled trial. Outpatient counselling facilities across the nation from different settings (rural/urban, Northern/Southern/Eastern/Western regions of the country) will deliver the interventions, as they hold the primary access to the target group in Germany. The control condition is a group programme with the same duration that is not addiction-specific. We expect that participants in the intervention condition will show a significant improvement in the use of adaptive coping strategies (in general and within the family) compared to the control condition as a direct result of the intervention. Data is collected shortly before and after as well as six months after the intervention. Discussion In Germany, the study presented here is the first to develop and evaluate a programme for children of substance-abusing parents. Limitations and strengths are discussed with a special focus on recruitment challenges as they appear to be the most potent threat to feasibility in the difficult-to-access target group at hand (Trial registration: ISRCTN81470784). PMID:22439919

  8. Targeting children of substance-using parents with the community-based group intervention TRAMPOLINE: A randomised controlled trial - design, evaluation, recruitment issues

    Directory of Open Access Journals (Sweden)

    Bröning Sonja

    2012-03-01

    Full Text Available Abstract Background Children of substance-abusing parents are at risk for developing psychosocial development problems. In Germany it is estimated that approx. 2.65 million children are affected by parental substance abuse or dependence. Only ten percent of them receive treatment when parents are treated. To date, no evaluated programme for children from substance-affected families exists in Germany. The study described in this protocol is designed to test the effectiveness of the group programme TRAMPOLINE for children aged 8-12 years with at least one substance-abusing or -dependent caregiver. The intervention is specifically geared to issues and needs of children from substance-affected families. Methods/Design The effectiveness of the manualised nine-session group programme TRAMPOLINE is tested among N = 218 children from substance-affected families in a multicentre randomised controlled trial. Outpatient counselling facilities across the nation from different settings (rural/urban, Northern/Southern/Eastern/Western regions of the country will deliver the interventions, as they hold the primary access to the target group in Germany. The control condition is a group programme with the same duration that is not addiction-specific. We expect that participants in the intervention condition will show a significant improvement in the use of adaptive coping strategies (in general and within the family compared to the control condition as a direct result of the intervention. Data is collected shortly before and after as well as six months after the intervention. Discussion In Germany, the study presented here is the first to develop and evaluate a programme for children of substance-abusing parents. Limitations and strengths are discussed with a special focus on recruitment challenges as they appear to be the most potent threat to feasibility in the difficult-to-access target group at hand (Trial registration: ISRCTN81470784.

  9. Targeting children of substance-using parents with the community-based group intervention TRAMPOLINE: a randomised controlled trial--design, evaluation, recruitment issues.

    Science.gov (United States)

    Bröning, Sonja; Wiedow, Annika; Wartberg, Lutz; Ruths, Sylvia; Haevelmann, Andrea; Kindermann, Sally-Sophie; Moesgen, Diana; Schaunig-Busch, Ines; Klein, Michael; Thomasius, Rainer

    2012-03-22

    Children of substance-abusing parents are at risk for developing psychosocial development problems. In Germany it is estimated that approx. 2.65 million children are affected by parental substance abuse or dependence. Only ten percent of them receive treatment when parents are treated. To date, no evaluated programme for children from substance-affected families exists in Germany. The study described in this protocol is designed to test the effectiveness of the group programme TRAMPOLINE for children aged 8-12 years with at least one substance-abusing or -dependent caregiver. The intervention is specifically geared to issues and needs of children from substance-affected families. The effectiveness of the manualised nine-session group programme TRAMPOLINE is tested among N = 218 children from substance-affected families in a multicentre randomised controlled trial. Outpatient counselling facilities across the nation from different settings (rural/urban, Northern/Southern/Eastern/Western regions of the country) will deliver the interventions, as they hold the primary access to the target group in Germany. The control condition is a group programme with the same duration that is not addiction-specific. We expect that participants in the intervention condition will show a significant improvement in the use of adaptive coping strategies (in general and within the family) compared to the control condition as a direct result of the intervention. Data is collected shortly before and after as well as six months after the intervention. In Germany, the study presented here is the first to develop and evaluate a programme for children of substance-abusing parents. Limitations and strengths are discussed with a special focus on recruitment challenges as they appear to be the most potent threat to feasibility in the difficult-to-access target group at hand (Trial registration: ISRCTN81470784).

  10. The SPHERE Study. Secondary prevention of heart disease in general practice: protocol of a randomised controlled trial of tailored practice and patient care plans with parallel qualitative, economic and policy analyses. [ISRCTN24081411].

    LENUS (Irish Health Repository)

    Murphy, Andrew W

    2005-07-29

    BACKGROUND: The aim of the SPHERE study is to design, implement and evaluate tailored practice and personal care plans to improve the process of care and objective clinical outcomes for patients with established coronary heart disease (CHD) in general practice across two different health systems on the island of Ireland. CHD is a common cause of death and a significant cause of morbidity in Ireland. Secondary prevention has been recommended as a key strategy for reducing levels of CHD mortality and general practice has been highlighted as an ideal setting for secondary prevention initiatives. Current indications suggest that there is considerable room for improvement in the provision of secondary prevention for patients with established heart disease on the island of Ireland. The review literature recommends structured programmes with continued support and follow-up of patients; the provision of training, tailored to practice needs of access to evidence of effectiveness of secondary prevention; structured recall programmes that also take account of individual practice needs; and patient-centred consultations accompanied by attention to disease management guidelines. METHODS: SPHERE is a cluster randomised controlled trial, with practice-level randomisation to intervention and control groups, recruiting 960 patients from 48 practices in three study centres (Belfast, Dublin and Galway). Primary outcomes are blood pressure, total cholesterol, physical and mental health status (SF-12) and hospital re-admissions. The intervention takes place over two years and data is collected at baseline, one-year and two-year follow-up. Data is obtained from medical charts, consultations with practitioners, and patient postal questionnaires. The SPHERE intervention involves the implementation of a structured systematic programme of care for patients with CHD attending general practice. It is a multi-faceted intervention that has been developed to respond to barriers and solutions to

  11. Habitual cocoa intake reduces arterial stiffness in postmenopausal women regardless of intake frequency: a randomized parallel-group study

    Directory of Open Access Journals (Sweden)

    Okamoto T

    2016-11-01

    Full Text Available Takanobu Okamoto,1 Ryota Kobayashi,1 Midori Natsume,2 Koichi Nakazato1 1Department of Exercise Physiology, Nippon Sport Science University, Tokyo, Japan; 2Food Sciences Research Laboratories, Meiji Co Ltd, Kanagawa, Japan Abstract: Arterial stiffness is substantially higher in postmenopausal than in premenopausal women. Daily cocoa intake has been shown to reduce central arterial stiffness in health adults, regardless of age; however, the effect of cocoa-intake frequency on arterial stiffness in postmenopausal women remains unclear. Therefore, the purpose of this study was to investigate the effects of cocoa-intake frequency on arterial stiffness in postmenopausal women. A total of 26 postmenopausal women (mean age ± standard deviation 64±12 years were randomly assigned to two groups with different cocoa-intake frequencies: one group ingested 17 g of cocoa once daily except on Sundays (every-day group, n=13, and the other ingested 17 g of cocoa twice daily every other day (every-other-day group, n=13. These intake regimens were maintained in both groups for 12 weeks. Carotid–femoral pulse-wave velocity and femoral–ankle pulse-wave velocity were measured in both groups at baseline and again at the end of the 12-week study period. Compared to baseline, both pulse-wave velocities had significantly decreased after the 12-week study period in both groups (P<0.05. However, no significant difference in degree of change was observed between the two groups. Although this study did not include a sedentary control group, these results suggest that regardless of frequency, habitual cocoa intake reduces central and peripheral arterial stiffness in postmenopausal women. Keywords: flavanol-enriched cocoa, pulse-wave velocity, intake frequency, endothelin 1

  12. Healthy ageing at work- Efficacy of group interventions on the mental health of nurses aged 45 and older: Results of a randomised, controlled trial.

    Directory of Open Access Journals (Sweden)

    Imad Maatouk

    Full Text Available This multicentre, randomised controlled trial (RCT aimed to evaluate the efficacy of a small-group intervention promoting successful ageing at work in older nurses (aged ≥45.A sample of 115 nurses aged ≥45 from 4 trial sites in Germany were randomly assigned to either the intervention group (IG, that received a small-group intervention of seven weekly sessions of 120 min with a booster session after six weeks or to a wait-list control condition (WLC. Outcomes were measured via validated self-report questionnaires at baseline (T1 and at post-treatment (T2. Primary outcomes were mental health-related well-being and mental health-related quality of life (QOL. The secondary outcomes included mental health-related and work-related measures.The intention to treat (ITT analysis showed significant positive effects of the intervention on mental health. A significant small effect (d = 0.3 in favour of the IG was found for psychological health-related quality of life. Positive small effects (d = 0.24 to d = 0.31 were also found for work related mental strain.Our small-group intervention based on a theory of successful ageing for nurses aged ≥45 was found to be effective with regard to improvements of psychological health related quality of life and other mental health-related outcomes. Thus, our study shows that the ageing workforce can be reached through specifically designed preventive interventions. The components of our intervention could be easily adapted to the belongings of other professions. Our results suggest that these components should be evaluated in various settings outside the healthcare sector.

  13. A traditional Chinese herbal formula improves pressure ulcers in paraplegic patients: A randomized, parallel-group, retrospective trial.

    Science.gov (United States)

    Liu, Xin; Meng, Qingxi; Song, Hua; Zhao, Tingbao

    2013-06-01

    In this study, the efficacy of a novel Chinese herbal formula, cure rot and flat sore ointment (CRFSO), in the management of stage IV pressure ulcers, and the effect of simultaneous comprehensive rehabilitation in improving the outcome were evaluated. A total of 35 paraplegic patients with stage IV pressure ulcers who underwent reconstruction and inpatient rehabilitation from January 2004 to September 2010 were included in the study. Arnebia root oil (ARO) was used on 16 patients with 11 ulcers (stage IV). The remaining 19 patients with 20 ulcers (stage IV) received a traditional Chinese herbal formula (CRFSO). After 28 days of treatment, the wound healing results, in particular, the healing rate, effectiveness rate, improvement rate and no response rate were evaluated. Six patients from the ARO group sought other types of therapy due to their own consideration of poor efficacy. After 28 days of treatment, the wound healing result and no response rate demonstrated a statistically significant difference (P<0.005) between the two groups, suggesting that the novel Chinese herbal formula is an effective treatment for pressure sores in paraplegic patients. All outcome variables demonstrated significant improvement in the CRFSO group compared with the ARO group after 28 days of treatment, with a higher healing rate (85% in the CRFSO group and 45.45% in the ARO group) and lower no response rate (5% in the CRFSO group and 18.18% in the ARO group). The traditional Chinese herbal formula improved pressure sores in paraplegic patients effectively and inpatient rehabilitation was also significantly improved.

  14. Renal effects of atorvastatin and rosuvastatin in patients with diabetes who have progressive renal disease (PLANET I) : a randomised clinical trial

    NARCIS (Netherlands)

    de Zeeuw, Dick; Anzalone, Deborah A.; Cain, Valerie A.; Cressman, Michael D.; Lambers Heerspink, Hiddo J.; Molitoris, Bruce A.; Monyak, John T.; Parving, Hans-Henrik; Remuzzi, Giuseppe; Sowers, James R.; Vidt, Donald G.

    Background The role of lipid-lowering treatments in renoprotection for patients with diabetes is debated. We studied the renal effects of two statins in patients with diabetes who had proteinuria. Methods PLANET I was a randomised, double-blind, parallel-group trial done in 147 research centres in

  15. Heart rate acceleration with GLP-1 receptor agonists in type 2 diabetes patients : an acute and 12-week randomised, double-blind, placebo-controlled trial

    NARCIS (Netherlands)

    Smits, Mark M; Tonneijck, Lennart; Muskiet, Marcel H A; Hoekstra, T.; Kramer, Mark H H; Diamant, Michaela; van Raalte, Daniël H

    OBJECTIVE: To examine mechanisms underlying resting heart rate (RHR) increments of GLP-1 receptor agonists in type 2 diabetes patients. DESIGN: Acute and 12-week randomised, placebo-controlled, double-blind, single-centre, parallel-group trial. METHODS: In total, 57 type 2 diabetes patients

  16. Treatment with a barrier-strengthening moisturizer prevents relapse of hand-eczema. An open, randomized, prospective, parallel group study.

    Science.gov (United States)

    Lodén, Marie; Wirén, Karin; Smerud, Knut; Meland, Nils; Hønnås, Helge; Mørk, Gro; Lützow-Holm, Claus; Funk, Jörgen; Meding, Birgitta

    2010-11-01

    Hand eczema influences the quality of life. Management strategies include the use of moisturizers. In the present study the time to relapse of eczema during treatment with a barrier-strengthening moisturizer (5% urea) was compared with no treatment (no medical or non-medicated preparations) in 53 randomized patients with successfully treated hand eczema. The median time to relapse was 20 days in the moisturizer group compared with 2 days in the no treatment group (p = 0.04). Eczema relapsed in 90% of the patients within 26 weeks. No difference in severity was noted between the groups at relapse. Dermatology Life Quality Index (DLQI) increased significantly in both groups; from 4.7 to 7.1 in the moisturizer group and from 4.1 to 7.8 in the no treatment group (p < 0.01) at the time of relapse. Hence, the application of moisturizers seems to prolong the disease-free interval in patients with controlled hand eczema. Whether the data is applic-able to moisturizers without barrier-strengthening properties remains to be elucidated.

  17. Effectiveness of a Group Support Lifestyle Modification (GSLiM Programme among Obese Adults in Workplace: A Randomised Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Siti Noraida Jamal

    Full Text Available There was an increasing trend in the prevalence of obesity and its comorbidities over the past decades in Malaysia. Effective intervention for obesity remains limited. This study aimed to compare the effectiveness of a group based lifestyle modification programme amongst obese individuals with an existing dietary counseling programme.We recruited one hundred and ninety four overweight and obese (BMI>27.5 kg/m2 employees from a local university. They were randomly allocated to either Group Support Lifestyle Modification (GSLiM (intervention(n = 97 or dietary counseling (comparison(n = 97. The GSLIM activities included self monitoring, cognitive-behaviour sessions, exercise as well as dietary change advocacy, which were conducted through seminars and group sessions over 24 weeks. The comparison group was given dietary counselling once in 12 weeks. Both groups were followed up for additional 12 weeks to check for intervention effect sustenance. Anthropometric and biochemical parameters were measured at baseline, 12, 24 and 36 weeks; while dietary intake, physical activities, psychological measures and quality of life measured at baseline, 24 and 36 weeks. Data analysis was conducted using ANOVA repeated measures with intention to treat principle.The participants were predominantly women with mean (standard deviation age of 40.5 (9.3 years. A total of 19.6% of the participants in GSLiM achieved 6% weight loss compared to 4.1% in the comparison group (Risk Ratio 4.75; 95% CI: 1.68, 13.45. At 24 weeks, the retention rate was 83.5% for GSLiM and 82.5% for comparison group. GSLiM participants also achieved significant improvement in total weight self-efficacy score, negative emotions and physical discomfort subscales, MDPSS friend subscale and all domains in quality of life. Participants in the comparison group experienced reduction in negative self-thoughts.The GSLiM programme proved to be more effective in achieving targeted weight loss, improving

  18. Effectiveness of a Group Support Lifestyle Modification (GSLiM) Programme among Obese Adults in Workplace: A Randomised Controlled Trial.

    Science.gov (United States)

    Jamal, Siti Noraida; Moy, Foong Ming; Azmi Mohamed, Mohd Nahar; Mukhtar, Firdaus

    2016-01-01

    There was an increasing trend in the prevalence of obesity and its comorbidities over the past decades in Malaysia. Effective intervention for obesity remains limited. This study aimed to compare the effectiveness of a group based lifestyle modification programme amongst obese individuals with an existing dietary counseling programme. We recruited one hundred and ninety four overweight and obese (BMI>27.5 kg/m2) employees from a local university. They were randomly allocated to either Group Support Lifestyle Modification (GSLiM) (intervention)(n = 97) or dietary counseling (comparison)(n = 97). The GSLIM activities included self monitoring, cognitive-behaviour sessions, exercise as well as dietary change advocacy, which were conducted through seminars and group sessions over 24 weeks. The comparison group was given dietary counselling once in 12 weeks. Both groups were followed up for additional 12 weeks to check for intervention effect sustenance. Anthropometric and biochemical parameters were measured at baseline, 12, 24 and 36 weeks; while dietary intake, physical activities, psychological measures and quality of life measured at baseline, 24 and 36 weeks. Data analysis was conducted using ANOVA repeated measures with intention to treat principle. The participants were predominantly women with mean (standard deviation) age of 40.5 (9.3) years. A total of 19.6% of the participants in GSLiM achieved 6% weight loss compared to 4.1% in the comparison group (Risk Ratio 4.75; 95% CI: 1.68, 13.45). At 24 weeks, the retention rate was 83.5% for GSLiM and 82.5% for comparison group. GSLiM participants also achieved significant improvement in total weight self-efficacy score, negative emotions and physical discomfort subscales, MDPSS friend subscale and all domains in quality of life. Participants in the comparison group experienced reduction in negative self-thoughts. The GSLiM programme proved to be more effective in achieving targeted weight loss, improving weight self

  19. Cognitive and Mood Effects of a Nutrient Enriched Breakfast Bar in Healthy Adults: A Randomised, Double-Blind, Placebo-Controlled, Parallel Groups Study

    Directory of Open Access Journals (Sweden)

    David O. Kennedy

    2017-12-01

    Full Text Available Objectives: Few previous studies have assessed the effects of concomitant administration of multiple potentially psychoactive nutrients. Methods: 95 healthy adult participants consumed either a nutrient enriched breakfast bar (containing α-Linolenic acid, l-tyrosine, l-theanine, vitamins, minerals and 21.5 mg of caffeine or an isocaloric, macronutrient matched control bar for 56 days. Cognitive function and mood were assessed pre-dose and at 40- and 160-min post-dose on the 1st and 56th day of the intervention period. Results: The results demonstrated acute effects of treatment across post-dose assessments on both assessment days in terms of alertness, and on tasks assessing attention, working and episodic memory and executive function, including cognitively demanding Serial subtraction and Rapid Visual Information Processing tasks. There were no evident chronic effects independent of the breakfast bars’ acute effects. Discussion: These results demonstrate that a nutrient enriched breakfast bar with low caffeine content can exert striking beneficial effects on acute cognitive function and alertness.

  20. Internet based self-help therapy versus waitlist control group for persons with anxiety disorders: A randomised feasibility study

    DEFF Research Database (Denmark)

    Fenger, Morten Munthe; Lindschou, Jane; Gluud, Christian

    ) FearFighter or B) waitlist control group. Participants are persons with a diagnosis of social phobia, agora phobia, phobia or panic disorder. The intervention with FearFighter is a nine step cognitive behavioural self-help therapy program delivered over the internet over nine weeks. Participants...

  1. Self-monitoring of urinary salt excretion as a method of salt-reduction education: a parallel, randomized trial involving two groups.

    Science.gov (United States)

    Yasutake, Kenichiro; Miyoshi, Emiko; Misumi, Yukiko; Kajiyama, Tomomi; Fukuda, Tamami; Ishii, Taeko; Moriguchi, Ririko; Murata, Yusuke; Ohe, Kenji; Enjoji, Munechika; Tsuchihashi, Takuya

    2018-02-20

    The present study aimed to evaluate salt-reduction education using a self-monitoring urinary salt-excretion device. Parallel, randomized trial involving two groups. The following parameters were checked at baseline and endline of the intervention: salt check sheet, eating behaviour questionnaire, 24 h home urine collection, blood pressure before and after urine collection. The intervention group self-monitored urine salt excretion using a self-measuring device for 4 weeks. In the control group, urine salt excretion was measured, but the individuals were not informed of the result. Seventy-eight individuals (control group, n 36; intervention group, n 42) collected two 24 h urine samples from a target population of 123 local resident volunteers. The samples were then analysed. There were no differences in clinical background or related parameters between the two groups. The 24 h urinary Na:K ratio showed a significant decrease in the intervention group (-1·1) compared with the control group (-0·0; P=0·033). Blood pressure did not change in either group. The results of the salt check sheet did not change in the control group but were significantly lower in the intervention group. The score of the eating behaviour questionnaire did not change in the control group, but the intervention group showed a significant increase in eating behaviour stage. Self-monitoring of urinary salt excretion helps to improve 24 h urinary Na:K, salt check sheet scores and stage of eating behaviour. Thus, usage of self-monitoring tools has an educational potential in salt intake reduction.

  2. 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.

  3. Boosted protease inhibitor monotherapy versus boosted protease inhibitor plus lamivudine dual therapy as second-line maintenance treatment for HIV-1-infected patients in sub-Saharan Africa (ANRS12 286/MOBIDIP): a multicentre, randomised, parallel, open-label, superiority trial.

    Science.gov (United States)

    Ciaffi, Laura; Koulla-Shiro, Sinata; Sawadogo, Adrien Bruno; Ndour, Cheik Tidiane; Eymard-Duvernay, Sabrina; Mbouyap, Pretty Rosereine; Ayangma, Liliane; Zoungrana, Jacques; Gueye, Ndeye Fatou Ngom; Diallo, Mohamadou; Izard, Suzanne; Bado, Guillaume; Kane, Coumba Toure; Aghokeng, Avelin Fobang; Peeters, Martine; Girard, Pierre Marie; Le Moing, Vincent; Reynes, Jacques; Delaporte, Eric

    2017-09-01

    Despite satisfactory efficacy of WHO-recommended second-line antiretroviral treatment for patients with HIV in low-income countries, the need for simplified, low-cost, and less-toxic maintenance strategies remains high. We compared boosted protease inhibitor monotherapy with dual therapy with boosted protease inhibitor plus lamivudine in patients on second-line antiretrovial therapy (ART). We did a multicentre, randomised, parallel, open-label, superiority, trial in the HIV services of five hospitals in sub-Saharan Africa (Yaoundé, Cameroon; Dakar, Senegal; and Bobo Dioulasso, Burkina Faso). We recruited patients from the long-term, post-trial cohort of the ANRS 12169/2LADY study that compared the efficacy of three second-line combinations based on boosted protease inhibitors. Participants for our study were HIV-1 infected with multiple mutations including M184V, at first-line failure, aged 18 years and older, on boosted protease inhibitor plus two nucleoside reverse transcriptase inhibitors (NRTI) for at least 48 weeks with at least 48 weeks follow-up in the 2LADY trial, with two viral load measurements of less than 200 copies per mL in the previous 6 months, CD4 counts of more than 100 cells per μL, adherence of at least 90%, and no change to ART in the past 3 months. We randomly assigned participants (1:1) to receive either monotherapy with their boosted protease inhibitor (once-daily darunavir 800 mg [two 400 mg tablets] boosted with ritonavir 100 mg [one tablet] or coformulation of lopinavir 200 mg with ritonavir 50 mg [two tablets taken twice per day]) or to boosted protease inhibitor plus once-daily lamivudine 300 mg (one 300 mg tablet or two 150 mg tablets). Computer-generated randomisation was stratified by study site and viral load at screening (treatment allocation was not masked from clinicians or patients]. Patients had follow-up visits at weeks 4 and 12, and every 3 months until 96 weeks; if viral load exceeded 500 copies per mL at any visit, NRTI

  4. Evaluating the benefits of a youth mental health curriculum for students in Nicaragua: a parallel-group, controlled pilot investigation.

    Science.gov (United States)

    Ravindran, Arun V; Herrera, Andres; da Silva, Tricia L; Henderson, Joanna; Castrillo, Magda Esther; Kutcher, Stan

    2018-01-01

    High rates of mental illness and addictions are well documented among youth in Nicaragua. Limited mental health services, poor mental health knowledge and stigma reduce help-seeking. The Mental Health Curriculum (MHC) is a Canadian school-based program that has shown a positive impact on such contributing factors. This pilot project evaluated the impact of the MHC on mental wellness and functioning among youth in Leon, Nicaragua. High school and university students (aged 14-25 years) were assigned to intervention (12-week MHC; n   =  567) and control (wait-list; n   =  346) groups in a non-randomized design. Both groups completed measures of mental health knowledge, stigma and function at baseline and 12 weeks. Multivariate analyses and repeated measures analyses were used to compare group outcomes. At baseline, intervention students showed higher substance use (mean difference [MD]  =  0.24) and lower perceived stress (MD = -1.36) than controls ( p   mental health knowledge (MD  =  1.75), lower stigma (MD  =  1.78), more adaptive coping (MD  =  0.82), better lifestyle choices (MD  =  0.06) and lower perceived stress (MD = -1.63) ( p   mental health knowledge, small to moderate for stigma and modest for the other variables. Substance use also decreased among intervention students to similar levels as controls (MD  =  0.03) ( p  > 0.05). This pilot investigation demonstrates the benefits of the MHC in a low-and-middle-income youth population. The findings replicate results found in Canadian student populations and support its cross-cultural applicability.

  5. Whole body and local cryotherapy in restless legs syndrome: A randomized, single-blind, controlled parallel group pilot study.

    Science.gov (United States)

    Happe, Svenja; Evers, Stefan; Thiedemann, Christian; Bunten, Sabine; Siegert, Rudolf

    2016-11-15

    Treatment of restless legs syndrome (RLS) is primarily based on drugs. Since many patients report improvement of symptoms due to cooling their legs, we examined the efficacy of cryotherapy in RLS. 35 patients (28 women, 60.9±12.5years) with idiopathic RLS and symptoms starting not later than 6pm were randomized into three groups: cold air chamber at -60°C (n=12); cold air chamber at -10°C (n=12); local cryotherapy at -17°C (n=11). After a two week baseline, the different therapies were applied three minutes daily at 6pm over two weeks, followed by a four week observation period. The patients completed several questionnaires regarding RLS symptoms, sleep, and quality of life on a weekly basis (IRLS, ESS), VAS and sleep/morning protocol were completed daily, MOSS/RLS-QLI were completed once in each period. Additionally, the PLM index was measured by a mobile device at the end of baseline, intervention, and follow-up. The IRLS score was chosen as primary efficacy parameter. At the end of follow-up, significant improvement of RLS symptoms and quality of life could be observed only in the -60°C group as compared to baseline (IRLS: p=0.009; RLS-QLI: p=0.006; ESS: p=0.020). Local cryotherapy led to improvement in quality of life (VAS4: p=0.028; RLS-QLI: p=0.014) and sleep quality (MOSS: p=0.020; MOSS2: p=0.022) but not in IRLS and ESS. In the -10°C group, the only significant effect was shortening of number of wake phases per night. Serious side-effects were not reported. Whole body cryotherapy at -60°C and, to a less extent, local cryotherapy seem to be a treatment option for RLS in addition to conventional pharmacological treatment. However, the exact mode of cryotherapy needs to be established. Copyright © 2016. Published by Elsevier B.V.

  6. Intensive versus conventional blood pressure monitoring in a general practice population. The Blood Pressure Reduction in Danish General Practice trial: a randomized controlled parallel group trial.

    Science.gov (United States)

    Klarskov, Pia; Bang, Lia E; Schultz-Larsen, Peter; Gregers Petersen, Hans; Benee Olsen, David; Berg, Ronan M G; Abrahamsen, Henrik; Wiinberg, Niels

    2018-01-17

    To compare the effect of a conventional to an intensive blood pressure monitoring regimen on blood pressure in hypertensive patients in the general practice setting. Randomized controlled parallel group trial with 12-month follow-up. One hundred and ten general practices in all regions of Denmark. One thousand forty-eight patients with essential hypertension. Conventional blood pressure monitoring ('usual group') continued usual ad hoc blood pressure monitoring by office blood pressure measurements, while intensive blood pressure monitoring ('intensive group') supplemented this with frequent home blood pressure monitoring and 24-hour ambulatory blood pressure monitoring. Mean day- and night-time systolic and diastolic 24-hour ambulatory blood pressure. Change in systolic and diastolic office blood pressure and change in cardiovascular risk profile. Of the patients, 515 (49%) were allocated to the usual group, and 533 (51%) to the intensive group. The reductions in day- and night-time 24-hour ambulatory blood pressure were similar (usual group: 4.6 ± 13.5/2.8 ± 82 mmHg; intensive group: 5.6 ± 13.0/3.5 ± 8.2 mmHg; P = 0.27/P = 0.20). Cardiovascular risk scores were reduced in both groups at follow-up, but more so in the intensive than in the usual group (P = 0.02). An intensive blood pressure monitoring strategy led to a similar blood pressure reduction to conventional monitoring. However, the intensive strategy appeared to improve patients' cardiovascular risk profile through other effects than a reduction of blood pressure. Clinical Trials NCT00244660. © The Author 2018. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  7. The Irish DAFNE study protocol: a cluster randomised trial of group versus individual follow-up after structured education for type 1 diabetes.

    LENUS (Irish Health Repository)

    Dinneen, Seán F

    2009-01-01

    BACKGROUND: Structured education programmes for individuals with Type 1 diabetes have become a recognised means of delivering the knowledge and skills necessary for optimal self-management of the condition. The Dose Adjustment for Normal Eating (DAFNE) programme has been shown to improve biomedical (HbA(1c) and rates of severe hypoglycaemia) and psychosocial outcomes for up to 12 months following course delivery. The optimal way to support DAFNE graduates and maintain the benefits of the programme has not been established. We aimed to compare 2 different methods of follow-up of DAFNE graduates in a pragmatic clinical trial delivered in busy diabetes clinics on the island of Ireland. METHODS: Six participating centres were cluster randomised to deliver either group follow-up or a return to traditional one-to-one clinic visits. In the intervention arm group follow-up was delivered at 6 and 12 months post DAFNE training according to a curriculum developed for the study. In the control arm patients were seen individually in diabetes clinics as part of routine care. Study outcomes included HbA(1c) levels, self-reported rates of severe hypoglycaemia, body weight and measures of diabetes wellbeing and quality of life. These were measured at 6, 12 and 18 months after recruitment. Generalisability (external validity) was maximised by recruiting study participants from existing DAFNE waiting lists in each centre, by using broad inclusion criteria (including HbA(1c) values less than 13 percent with no lower limit) and by using existing clinic staff to deliver the training and follow-up. Internal validity and treatment fidelity were maximised by quality assuring the training of all DAFNE educators, by external peer review of the group follow-up sessions and by striving for full attendance at follow-up visits. Assays of HbA(1c) were undertaken in a central laboratory. DISCUSSION: This pragmatic clinical trial evaluating group follow-up after a structured education programme has

  8. A high-dose preparation of lactobacilli and bifidobacteria in the prevention of antibiotic-associated and Clostridium difficile diarrhoea in older people admitted to hospital: a multicentre, randomised, double-blind, placebo-controlled, parallel arm trial (PLACIDE).

    Science.gov (United States)

    Allen, S J; Wareham, K; Wang, D; Bradley, C; Sewell, B; Hutchings, H; Harris, W; Dhar, A; Brown, H; Foden, A; Gravenor, M B; Mack, D; Phillips, C J

    2013-12-01

    Antibiotic-associated diarrhoea (AAD) occurs most commonly in older people admitted to hospital and within 12 weeks of exposure to broad-spectrum antibiotics. Although usually a mild and self-limiting illness, the 15-39% of cases caused by Clostridium difficile infection [C. difficile diarrhoea (CDD)] may result in severe diarrhoea and death. Previous research has shown that probiotics, live microbial organisms that, when administered in adequate numbers, are beneficial to health, may be effective in preventing AAD and CDD. To determine the clinical effectiveness and cost-effectiveness of a high-dose, multistrain probiotic in the prevention of AAD and CDD in older people admitted to hospital. A multicentre, randomised, double-blind, placebo-controlled, parallel-arm trial. Medical, surgical and elderly care inpatient wards in five NHS hospitals in the UK. Eligible patients were aged ≥ 65 years, were exposed to one or more oral or parenteral antibiotics and were without pre-existing diarrhoeal disorders, recent CDD or at risk of probiotic adverse effects. Out of 17,420 patients screened, 2981 (17.1%) were recruited. Participants were allocated sequentially according to a computer-generated random allocation sequence; 1493 (50.1%) were allocated to the probiotic and 1488 (49.9%) to the placebo arm. Vegetarian capsules containing two strains of lactobacilli and two strains of bifidobacteria (a total of 6 × 10(10) organisms per day) were taken daily for 21 days. The placebo was inert maltodextrin powder in identical capsules. The occurrence of AAD within 8 weeks and CDD within 12 weeks of recruitment was determined by participant follow-up and checking hospital laboratory records by research nurses who were blind to arm allocation. Analysis based on the treatment allocated included 2941 (98.7%) participants. Potential risk factors for AAD at baseline were similar in the two study arms. Frequency of AAD (including CDD) was similar in the probiotic (159/1470, 10

  9. Pharmacodynamic effects of steady-state fingolimod on antibody response in healthy volunteers: a 4-week, randomized, placebo-controlled, parallel-group, multiple-dose study.

    Science.gov (United States)

    Boulton, Craig; Meiser, Karin; David, Olivier J; Schmouder, Robert

    2012-12-01

    Fingolimod, a first-in-class oral sphingosine 1-phosphate receptor (S1PR) modulator, is approved in many countries for relapsing-remitting multiple sclerosis, at a once-daily 0.5-mg dose. A reduction in peripheral lymphocyte count is an expected consequence of the fingolimod mechanism of S1PR modulation. The authors investigated if this pharmacodynamic effect impacts humoral and cellular immunogenicity. In this double-blind, parallel-group, 4-week study, 72 healthy volunteers were randomized to steady state, fingolimod 0.5 mg, 1.25 mg, or to placebo. The authors compared T-cell dependent and independent responses to the neoantigens, keyhole limpet hemocyanin (KLH), and pneumococcal polysaccharides vaccine (PPV-23), respectively, and additionally recall antigen response (tetanus toxoid [TT]) and delayed-type hypersensitivity (DTH) to KLH, TT, and Candida albicans. Fingolimod caused mild to moderate decreases in anti-KLH and anti-PPV-23 IgG and IgM levels versus placebo. Responder rates were identical between placebo and 0.5-mg groups for anti-KLH IgG (both > 90%) and comparable for anti-PPV-23 IgG (55% and 41%, respectively). Fingolimod did not affect anti-TT immunogenicity, and DTH response did not differ between placebo and fingolimod 0.5-mg groups. Expectedly, lymphocyte count reduced substantially in the fingolimod groups versus placebo but reversed by study end. Fingolimod was well tolerated, and the observed safety profile was consistent with previous reports.

  10. Randomized, parallel-group, double-blind, controlled study to evaluate the efficacy and safety of carbohydrate-derived fulvic acid in topical treatment of eczema

    Directory of Open Access Journals (Sweden)

    Gandy JJ

    2011-09-01

    Full Text Available Justin J Gandy, Jacques R Snyman, Constance EJ van RensburgDepartment of Pharmacology, Faculty of Health Sciences, University of Pretoria, Pretoria, South AfricaBackground: The purpose of this study was to evaluate the efficacy and safety of carbohydrate-derived fulvic acid (CHD-FA in the treatment of eczema in patients two years and older.Methods: In this single-center, double-blind, placebo-controlled, parallel-group comparative study, 36 volunteers with predetermined eczema were randomly assigned to receive either the study drug or placebo twice daily for four weeks.Results: All safety parameters remained within normal limits, with no significant differences in either group. Significant differences were observed for both severity and erythema in the placebo and CHD-FA treated groups, and a significant difference was observed for scaling in the placebo-treated group. With regard to the investigator assessment of global response to treatment, a significant improvement was observed in the CHD-FA group when compared with the placebo group. A statistically significant decrease in visual analog scale score was observed in both groups, when comparing the baseline with the final results.Conclusion: CHD-FA was well tolerated, with no difference in reported side effects other than a short-lived burning sensation on application. CHD-FA significantly improved some aspects of eczema. Investigator assessment of global response to treatment with CHD-FA was significantly better than that with emollient therapy alone. The results of this small exploratory study suggest that CHD-FA warrants further investigation in the treatment of eczema.Keywords: fulvic acid, eczema, anti-inflammatory, efficacy, safety

  11. Providing full point-to-point communications among compute nodes of an operational group in a global combining network of a parallel computer

    Energy Technology Data Exchange (ETDEWEB)

    Archer, Charles J.; Faraj, Daniel A.; Inglett, Todd A.; Ratterman, Joseph D.

    2018-01-30

    Methods, apparatus, and products are disclosed for providing full point-to-point communications among compute nodes of an operational group in a global combining network of a parallel computer, each compute node connected to each adjacent compute node in the global combining network through a link, that include: receiving a network packet in a compute node, the network packet specifying a destination compute node; selecting, in dependence upon the destination compute node, at least one of the links for the compute node along which to forward the network packet toward the destination compute node; and forwarding the network packet along the selected link to the adjacent compute node connected to the compute node through the selected link.

  12. A double blind parallel group placebo controlled comparison of sedative and mnesic effects of etifoxine and lorazepam in healthy subjects [corrected].

    Science.gov (United States)

    Micallef, J; Soubrouillard, C; Guet, F; Le Guern, M E; Alquier, C; Bruguerolle, B; Blin, O

    2001-06-01

    This paper describes the psychomotor and mnesic effects of single oral doses of etifoxine (50 and 100 mg) and lorazepam (2 mg) in healthy subjects. Forty-eight healthy subjects were included in this randomized double blind, placebo controlled parallel group study [corrected]. The effects of drugs were assessed by using a battery of subjective and objective tests that explored mood and vigilance (Visual Analog Scale), attention (Barrage test), psychomotor performance (Choice Reaction Time) and memory (digit span, immediate and delayed free recall of a word list). Whereas vigilance, psychomotor performance and free recall were significantly impaired by lorazepam, neither dosage of etifoxine (50 and 100 mg) produced such effects. These results suggest that 50 and 100 mg single dose of etifoxine do not induce amnesia and sedation as compared to lorazepam.

  13. A Randomized Single Blind Parallel Group Study Comparing Monoherbal Formulation Containing Holarrhena antidysenterica Extract with Mesalamine in Chronic Ulcerative Colitis Patients

    Directory of Open Access Journals (Sweden)

    Sarika Johari

    2016-01-01

    Full Text Available Background: Incidences of side effects and relapses are very common in chronic ulcerative colitis patients after termination of the treatment. Aims and Objectives: This study aims to compare the treatment with monoherbal formulation of Holarrhena antidysenterica with Mesalamine in chronic ulcerative colitis patients with special emphasis to side effects and relapse. Settings and Design: Patients were enrolled from an Ayurveda Hospital and a private Hospital, Gujarat. The study was randomized, parallel group and single blind design. Materials and Methods: The protocol was approved by Institutional Human Research Ethics Committee of Anand Pharmacy College on 23rd Jan 2013. Three groups (n = 10 were treated with drug Mesalamine (Group I, monoherbal tablet (Group II and combination of both (Group III respectively. Baseline characteristics, factors affecting quality of life, chronicity of disease, signs and symptoms, body weight and laboratory investigations were recorded. Side effects and complications developed, if any were recorded during and after the study. Statistical Analysis Used: Results were expressed as mean ± SEM. Data was statistically evaluated using t-test, Wilcoxon test, Mann Whitney U test, Kruskal Wallis test and ANOVA, wherever applicable, using GraphPad Prism 6. Results: All the groups responded positively to the treatments. All the patients were positive for occult blood in stool which reversed significantly after treatment along with rise in hemoglobin. Patients treated with herbal tablets alone showed maximal reduction in abdominal pain, diarrhea, and bowel frequency and stool consistency scores than Mesalamine treated patients. Treatment with herbal tablet alone and in combination with Mesalamine significantly reduced the stool infection. Patients treated with herbal drug alone and in combination did not report any side effects, relapse or complications while 50% patients treated with Mesalamine exhibited the relapse with

  14. Improvement of defecation in healthy individuals with infrequent bowel movements through the ingestion of dried Mozuku powder: a randomized, double-blind, parallel-group study

    Directory of Open Access Journals (Sweden)

    Masaki Matayoshi

    2017-09-01

    Full Text Available Background: Okinawa mozuku (Cladosiphon okamuranu is a type of edible seaweed of the family Chordariaceae that typically contains the polysaccharide fucoidan as a functional ingredient. In Okinawa, raw mozuku is eaten as vinegared mozuku together with vinegar or as tempura (deep-fried in batter. Polysaccharides such as fucoidan are generally known to regulate intestinal function, which is why we have used Okinawa mozuku to investigate this intestinal regulatory effect. Methods: The study was designed as a randomized, double-blind, parallel group study. Dried Okinawa mozuku powder at a dose of 2.4 g/day (1.0 g/day of fucoidan and a placebo not containing any dried Okinawa mozuku powder were each made into capsules and given to healthy men and women with infrequent weekly bowel movements (2–4 movements a week to ingest for eight weeks. We then investigated changes in the defecation situation, blood tests, and adverse events. Results: In the group that ingested the capsules containing dried Okinawa mozuku powder, the number of days with a bowel movement significantly increased compared with the placebo group after four weeks of ingestion (p < 0.05. Furthermore, after eight weeks of ingestion, the same increasing trend was seen compared with the placebo group (p = 0.0964. The volume of stool also increased significantly in the dried Okinawa mozuku powder group after eight weeks compared with the placebo group. In terms of blood tests and adverse events, no adverse events occurred that were the result of the test food. Conclusions: Ingestion of Okinawa mozuku was found to have a regulatory effect on intestinal function by promoting defecation in healthy individuals with a tendency for constipation. This demonstrated that Okinawa mozuku is a functional food capable of making defecation smoother and increasing the volume of stool.

  15. Parallel rendering

    Science.gov (United States)

    Crockett, Thomas W.

    1995-01-01

    This article provides a broad introduction to the subject of parallel rendering, encompassing both hardware and software systems. The focus is on the underlying concepts and the issues which arise in the design of parallel rendering algorithms and systems. We examine the different types of parallelism and how they can be applied in rendering applications. Concepts from parallel computing, such as data decomposition, task granularity, scalability, and load balancing, are considered in relation to the rendering problem. We also explore concepts from computer graphics, such as coherence and projection, which have a significant impact on the structure of parallel rendering algorithms. Our survey covers a number of practical considerations as well, including the choice of architectural platform, communication and memory requirements, and the problem of image assembly and display. We illustrate the discussion with numerous examples from the parallel rendering literature, representing most of the principal rendering methods currently used in computer graphics.

  16. Daily consumption of fermented soymilk helps to improve facial wrinkles in healthy postmenopausal women in a randomized, parallel-group, open-label trial

    Directory of Open Access Journals (Sweden)

    Mitsuyoshi Kano

    2018-02-01

    Full Text Available Background: Soymilk fermented by lactobacilli and/or bifidobacteria is attracting attention due to the excellent bioavailability of its isoflavones. We investigated the effects of fermented soymilk containing high amounts of isoflavone aglycones on facial wrinkles and urinary isoflavones in postmenopausal women in a randomized, parallel-group, open-label trial. Healthy Japanese women were randomly divided into active (n = 44, mean age 56.3 ± 0.5 or control (n = 44, mean age 56.1 ± 0.5 groups, who consumed or did not consume a bottle of soymilk fermented by Bifidobacterium breve strain Yakult and Lactobacillus mali for 8 weeks. Maximum depth of wrinkles around the crow’s feet area and other wrinkle parameters were evaluated as primary and secondary endpoints respectively at weeks 0, 4, and 8 during the consumption period. Urinary isoflavone levels were determined by liquid chromatography-mass spectrometry. Results: The active group demonstrated significant improvements in the maximum depth (p=0.015 and average depth (p=0.04 of wrinkles, and significantly elevated urinary isoflavones (daidzein, genistein, and glycitein; each p < 0.001 compared with the control during the consumption period. No serious adverse effects were recorded. Conclusion: These findings suggest that fermented soymilk taken daily may improve facial wrinkles and elevate urinary isoflavones in healthy postmenopausal women.

  17. Immediate versus delayed loading of strategic mini dental implants for the stabilization of partial removable dental prostheses: a patient cluster randomized, parallel-group 3-year trial.

    Science.gov (United States)

    Mundt, Torsten; Al Jaghsi, Ahmad; Schwahn, Bernd; Hilgert, Janina; Lucas, Christian; Biffar, Reiner; Schwahn, Christian; Heinemann, Friedhelm

    2016-07-30

    Acceptable short-term survival rates (>90 %) of mini-implants (diameter implants as strategic abutments for a better retention of partial removable dental prosthesis (PRDP) are not available. The purpose of this study is to test the hypothesis that immediately loaded mini-implants show more bone loss and less success than strategic mini-implants with delayed loading. In this four-center (one university hospital, three dental practices in Germany), parallel-group, controlled clinical trial, which is cluster randomized on patient level, a total of 80 partially edentulous patients with unfavourable number and distribution of remaining abutment teeth in at least one jaw will receive supplementary min-implants to stabilize their PRDP. The mini-implant are either immediately loaded after implant placement (test group) or delayed after four months (control group). Follow-up of the patients will be performed for 36 months. The primary outcome is the radiographic bone level changes at implants. The secondary outcome is the implant success as a composite variable. Tertiary outcomes include clinical, subjective (quality of life, satisfaction, chewing ability) and dental or technical complications. Strategic implants under an existing PRDP are only documented for standard-diameter implants. Mini-implants could be a minimal invasive and low cost solution for this treatment modality. The trial is registered at Deutsches Register Klinischer Studien (German register of clinical trials) under DRKS-ID: DRKS00007589 ( www.germanctr.de ) on January 13(th), 2015.

  18. Parallel computations

    CERN Document Server

    1982-01-01

    Parallel Computations focuses on parallel computation, with emphasis on algorithms used in a variety of numerical and physical applications and for many different types of parallel computers. Topics covered range from vectorization of fast Fourier transforms (FFTs) and of the incomplete Cholesky conjugate gradient (ICCG) algorithm on the Cray-1 to calculation of table lookups and piecewise functions. Single tridiagonal linear systems and vectorized computation of reactive flow are also discussed.Comprised of 13 chapters, this volume begins by classifying parallel computers and describing techn

  19. A novel reflux inhibitor lesogaberan (AZD3355) as add-on treatment in patients with GORD with persistent reflux symptoms despite proton pump inhibitor therapy: a randomised placebo-controlled trial

    NARCIS (Netherlands)

    Boeckxstaens, Guy E.; Beaumont, Hanneke; Hatlebakk, Jan G.; Silberg, Debra G.; Björck, Karin; Karlsson, Maria; Denison, Hans

    2011-01-01

    o evaluate the efficacy and tolerability of add-on treatment with lesogaberan (AZD3355), a novel reflux inhibitor, in patients with persistent gastro-oesophageal reflux disease (GORD) symptoms despite proton pump inhibitor (PPI) therapy. double-blind, placebo-controlled, randomised, parallel-group,

  20. Effectiveness and cost-effectiveness of a brief school-based group programme for parents of children at risk of ADHD: a cluster randomised controlled trial.

    Science.gov (United States)

    Sayal, K; Taylor, J A; Valentine, A; Guo, B; Sampson, C J; Sellman, E; James, M; Hollis, C; Daley, D

    2016-07-01

    National Institute for Health and Care Excellence guidelines recommend a stepped care approach for the identification and management of children with, or at risk of, attention-deficit/hyperactivity disorder (ADHD). We investigated the effectiveness, cost-effectiveness and acceptability of a group parenting intervention programme (+/- a teacher session) for children at risk of ADHD. In a three-arm cluster randomised controlled trial, 12 primary schools were randomly assigned to control, parent-only and combined (parent + teacher) intervention arms. Eligible children had high levels of parent-rated hyperactivity/inattention (n = 199). At 6 month follow-up, the primary outcome measure was the parent-completed Conners' Rating Scale - Revised (ADHD index). Secondary outcomes included the Conners' sub-scales (hyperactivity, cognitive problems/inattention and oppositional behaviour), the teacher-completed Conners' Rating Scale - Revised, child health-related quality of life, parental burden and parental mental health. The cost-effectiveness analyses reflected a health and personal social services perspective. ISRCTN87634685. Follow-up data were obtained from 76 parents and 169 teachers. There was no effect of the parent-only (mean difference = -1.1, 95% CI -5.1,2.9; p = 0.57) or combined interventions (mean difference = -2.1, 95% CI -6.4,2.1; p = 0.31) on the ADHD index. The combined intervention was associated with reduced parent-reported hyperactivity symptoms (mean difference = -5.3; 95% CI -10.5,-0.01; p = 0.05) and the parent-only intervention with improved parental mental health (mean difference = -1.9; 95% CI -3.2,-0.5; p = 0.009). The incremental costs of the parent-only and the combined interventions were £73 and £123, respectively. Above a willingness-to-pay of £31 per one-point improvement in the ADHD index, the parent-only programme had the highest probability of cost-effectiveness. Participants found the

  1. Effect of participatory women's groups and counselling through home visits on children's linear growth in rural eastern India (CARING trial): a cluster-randomised controlled trial.

    Science.gov (United States)

    Nair, Nirmala; Tripathy, Prasanta; Sachdev, H S; Pradhan, Hemanta; Bhattacharyya, Sanghita; Gope, Rajkumar; Gagrai, Sumitra; Rath, Shibanand; Rath, Suchitra; Sinha, Rajesh; Roy, Swati Sarbani; Shewale, Suhas; Singh, Vijay; Srivastava, Aradhana; Costello, Anthony; Copas, Andrew; Skordis-Worrall, Jolene; Haghparast-Bidgoli, Hassan; Saville, Naomi; Prost, Audrey

    2017-10-01

    Around 30% of the world's stunted children live in India. The Government of India has proposed a new cadre of community-based workers to improve nutrition in 200 districts. We aimed to find out the effect of such a worker carrying out home visits and participatory group meetings on children's linear growth. We did a cluster-randomised controlled trial in two adjoining districts of Jharkhand and Odisha, India. 120 clusters (around 1000 people each) were randomly allocated to intervention or control using a lottery. Randomisation took place in July, 2013, and was stratified by district and number of hamlets per cluster (0, 1-2, or ≥3), resulting in six strata. In each intervention cluster, a worker carried out one home visit in the third trimester of pregnancy, monthly visits to children younger than 2 years to support feeding, hygiene, care, and stimulation, as well as monthly women's group meetings to promote individual and community action for nutrition. Participants were pregnant women identified and recruited in the study clusters and their children. We excluded stillbirths and neonatal deaths, infants whose mothers died, those with congenital abnormalities, multiple births, and mother and infant pairs who migrated out of the study area permanently during the trial period. Data collectors visited each woman in pregnancy, within 72 h of her baby's birth, and at 3, 6, 9, 12, and 18 months after birth. The primary outcome was children's length-for-age Z score at 18 months of age. Analyses were by intention to treat. Due to the nature of the intervention, participants and the intervention team were not masked to allocation. Data collectors and the data manager were masked to allocation. The trial is registered as ISCRTN (51505201) and with the Clinical Trials Registry of India (number 2014/06/004664). Between Oct 1, 2013, and Dec 31, 2015, we recruited 5781 pregnant women. 3001 infants were born to pregnant women recruited between Oct 1, 2013, and Feb 10, 2015

  2. A phase 2a randomized, parallel group, dose-ranging study of molindone in children with attention-deficit/hyperactivity disorder and persistent, serious conduct problems.

    Science.gov (United States)

    Stocks, Jennifer Dugan; Taneja, Baldeo K; Baroldi, Paolo; Findling, Robert L

    2012-04-01

    To evaluate safety and tolerability of four doses of immediate-release molindone hydrochloride in children with attention-deficit/hyperactivity disorder (ADHD) and serious conduct problems. This open-label, parallel-group, dose-ranging, multicenter trial randomized children, aged 6-12 years, with ADHD and persistent, serious conduct problems to receive oral molindone thrice daily for 9-12 weeks in four treatment groups: Group 1-10 mg (5 mg if weight conduct problems. Secondary outcome measures included change in Nisonger Child Behavior Rating Form-Typical Intelligence Quotient (NCBRF-TIQ) Conduct Problem subscale scores, change in Clinical Global Impressions-Severity (CGI-S) and -Improvement (CGI-I) subscale scores from baseline to end point, and Swanson, Nolan, and Pelham rating scale-revised (SNAP-IV) ADHD-related subscale scores. The study randomized 78 children; 55 completed the study. Treatment with molindone was generally well tolerated, with no clinically meaningful changes in laboratory or physical examination findings. The most common treatment-related adverse events (AEs) included somnolence (n=9), weight increase (n=8), akathisia (n=4), sedation (n=4), and abdominal pain (n=4). Mean weight increased by 0.54 kg, and mean body mass index by 0.24 kg/m(2). The incidence of AEs and treatment-related AEs increased with increasing dose. NCBRF-TIQ subscale scores improved in all four treatment groups, with 34%, 34%, 32%, and 55% decreases from baseline in groups 1, 2, 3, and 4, respectively. CGI-S and SNAP-IV scores improved over time in all treatment groups, and CGI-I scores improved to the greatest degree in group 4. Molindone at doses of 5-20 mg/day (children weighing <30 kg) and 20-40 mg (≥ 30 kg) was well tolerated, and preliminary efficacy results suggest that molindone produces dose-related behavioral improvements over 9-12 weeks. Additional double-blind, placebo-controlled trials are needed to further investigate molindone in this pediatric population.

  3. Evaluation of pulsing magnetic field effects on paresthesia in multiple sclerosis patients, a randomized, double-blind, parallel-group clinical trial.

    Science.gov (United States)

    Afshari, Daryoush; Moradian, Nasrin; Khalili, Majid; Razazian, Nazanin; Bostani, Arash; Hoseini, Jamal; Moradian, Mohamad; Ghiasian, Masoud

    2016-10-01

    Evidence is mounting that magnet therapy could alleviate the symptoms of multiple sclerosis (MS). This study was performed to test the effects of the pulsing magnetic fields on the paresthesia in MS patients. This study has been conducted as a randomized, double-blind, parallel-group clinical trial during the April 2012 to October 2013. The subjects were selected among patients referred to MS clinic of Imam Reza Hospital; affiliated to Kermanshah University of Medical Sciences, Iran. Sixty three patients with MS were included in the study and randomly were divided into two groups, 35 patients were exposed to a magnetic pulsing field of 4mT intensity and 15-Hz frequency sinusoidal wave for 20min per session 2 times per week over a period of 2 months involving 16 sessions and 28 patients was exposed to a magnetically inactive field (placebo) for 20min per session 2 times per week over a period of 2 months involving 16 sessions. The severity of paresthesia was measured by the numerical rating scale (NRS) at 30, 60days. The study primary end point was NRS change between baseline and 60days. The secondary outcome was NRS change between baseline and 30days. Patients exposing to magnetic field showed significant paresthesia improvement compared with the group of patients exposing to placebo. According to our results pulsed magnetic therapy could alleviate paresthesia in MS patients .But trials with more patients and longer duration are mandatory to describe long-term effects. Copyright © 2016 Elsevier B.V. All rights reserved.

  4. The effect of a corticosteroid cream and a barrier-strengthening moisturizer in hand eczema. A double-blind, randomized, prospective, parallel group clinical trial.

    Science.gov (United States)

    Lodén, M; Wirén, K; Smerud, K T; Meland, N; Hønnås, H; Mørk, G; Lützow-Holm, C; Funk, J; Meding, B

    2012-05-01

    Hand eczema is a common and persistent disease with a relapsing course. Clinical data suggest that once daily treatment with corticosteroids is just as effective as twice daily treatment. The aim of this study was to compare once and twice daily applications of a strong corticosteroid cream in addition to maintenance therapy with a moisturizer in patients with a recent relapse of hand eczema. The study was a parallel, double-blind, randomized, clinical trial on 44 patients. Twice daily application of a strong corticosteroid cream (betamethasone valerate 0.1%) was compared with once daily application, where a urea-containing moisturizer was substituted for the corticosteroid cream in the morning. The investigator scored the presence of eczema and the patients judged the health-related quality of life (HRQoL) using the Dermatology Life Quality Index (DLQI), which measures how much the patient's skin problem has affected his/her life over the past week. The patients also judged the severity of their eczema daily on a visual analogue scale. Both groups improved in terms of eczema and DLQI. However, the clinical scoring demonstrated that once daily application of corticosteroid was superior to twice daily application in diminishing eczema, especially in the group of patients with lower eczema scores at inclusion. Twice daily use of corticosteroids was not superior to once daily use in treating eczema. On the contrary, the clinical assessment showed a larger benefit from once daily treatment compared with twice daily, especially in the group of patients with a moderate eczema at inclusion. © 2011 The Authors. Journal of the European Academy of Dermatology and Venereology © 2011 European Academy of Dermatology and Venereology.

  5. Parallel algorithms

    CERN Document Server

    Casanova, Henri; Robert, Yves

    2008-01-01

    ""…The authors of the present book, who have extensive credentials in both research and instruction in the area of parallelism, present a sound, principled treatment of parallel algorithms. … This book is very well written and extremely well designed from an instructional point of view. … The authors have created an instructive and fascinating text. The book will serve researchers as well as instructors who need a solid, readable text for a course on parallelism in computing. Indeed, for anyone who wants an understandable text from which to acquire a current, rigorous, and broad vi

  6. Design paper: The CapOpus trial: a randomized, parallel-group, observer-blinded clinical trial of specialized addiction treatment versus treatment as usual for young patients with cannabis abuse and psychosis

    DEFF Research Database (Denmark)

    Hjorthøj, Carsten; Fohlmann, Allan; Larsen, Anne-Mette

    2008-01-01

    : The major objective for the CapOpus trial is to evaluate the additional effect on cannabis abuse of a specialized addiction treatment program adding group treatment and motivational interviewing to treatment as usual. DESIGN: The trial is designed as a randomized, parallel-group, observer-blinded clinical...

  7. Effects on Subclinical Heart Failure in Type 2 Diabetic Subjects on Liraglutide Treatment vs. Glimepiride Both in Combination with Metformin: A Randomized Open Parallel-Group Study.

    Science.gov (United States)

    Nyström, Thomas; Padro Santos, Irene; Hedberg, Fredric; Wardell, Johan; Witt, Nils; Cao, Yang; Bojö, Leif; Nilsson, Bo; Jendle, Johan

    2017-01-01

    We aimed to investigate the effect of liraglutide treatment on heart function in type 2 diabetes (T2D) patients with subclinical heart failure. Randomized open parallel-group trial. 62 T2D patients (45 male) with subclinical heart failure were randomized to either once daily liraglutide 1.8 mg, or glimepiride 4 mg, both add on to metformin 1 g twice a day. Mitral annular systolic (s') and early diastolic (e') velocities were measured at rest and during bicycle ergometer exercise, using tissue Doppler echocardiography. The primary endpoint was 18-week treatment changes in longitudinal functional reserve index (LFRI diastolic/systolic ). Clinical characteristics between groups (liraglutide = 33 vs. glimepiride = 29) were well matched. At baseline left ventricle ejection fraction (53.7 vs. 53.6%) and global longitudinal strain (-15.3 vs. -16.5%) did not differ between groups. There were no significant differences in mitral flow velocities between groups. For the primary endpoint, there was no treatment change [95% confidence interval] for: LFRI diastolic (-0.18 vs. -0.53 [-0.28, 2.59; p  = 0.19]), or LFRI systolic (-0.10 vs. -0.18 [-1.0, 1.7; p  = 0.54]); for the secondary endpoints, there was a significant treatment change in respect of body weight (-3.7 vs. -0.2 kg [-5.5, -1.4; p  = 0.001]), waist circumference (-3.1 vs. -0.8 cm [-4.2, -0.4; p  = 0.019]), and heart rate (HR) (6.3 vs. -2.3 bpm [-3.0, 14.2; p  = 0.003]), with no such treatment change in hemoglobin A1c levels (-11.0 vs. -9.2 mmol/mol [-7.0, 2.6; p  = 0.37]), between groups. 18-week treatment of liraglutide compared with glimepiride did not improve LFRI diastolic/systolic , but however increased HR. There was a significant treatment change in body weight reduction in favor for liraglutide treatment.

  8. The MANDELA study: A multicenter, randomized, open-label, parallel group trial to refine the use of everolimus after heart transplantation.

    Science.gov (United States)

    Deuse, Tobias; Bara, Christoph; Barten, Markus J; Hirt, Stephan W; Doesch, Andreas O; Knosalla, Christoph; Grinninger, Carola; Stypmann, Jörg; Garbade, Jens; Wimmer, Peter; May, Christoph; Porstner, Martina; Schulz, Uwe

    2015-11-01

    In recent years a series of trials has sought to define the optimal protocol for everolimus-based immunosuppression in heart transplantation, with the goal of minimizing exposure to calcineurin inhibitors (CNIs) and harnessing the non-immunosuppressive benefits of everolimus. Randomized studies have demonstrated that immunosuppressive potency can be maintained in heart transplant patients receiving everolimus despite marked CNI reduction, although very early CNI withdrawal may be inadvisable. A potential renal advantage has been shown for everolimus, but the optimal time for conversion and the adequate reduction in CNI exposure remain to be defined. Other reasons for use of everolimus include a substantial reduction in the risk of cytomegalovirus infection, and evidence for inhibition of cardiac allograft vasculopathy, a major cause of graft loss. The ongoing MANDELA study is a 12-month multicenter, randomized, open-label, parallel-group study in which efficacy, renal function and safety are compared in approximately 200 heart transplant patients. Patients receive CNI therapy, steroids and everolimus or mycophenolic acid during months 3 to 6 post-transplant, and are then randomized at month 6 post-transplant (i) to convert to CNI-free immunosuppression with everolimus and mycophenolic acid or (ii) to continue reduced-exposure CNI, with concomitant everolimus. Patients are then followed to month 18 post-transplant The rationale and expectations for the trial and its methodology are described herein. Copyright © 2015 Elsevier Inc. All rights reserved.

  9. Cost-effectiveness of an intensive group training protocol compared to physiotherapy guideline care for sub-acute and chronic low back pain: design of a randomised controlled trial with an economic evaluation. [ISRCTN45641649

    Directory of Open Access Journals (Sweden)

    Franken Willemien K

    2004-11-01

    Full Text Available Abstract Background Low back pain is a common disorder in western industrialised countries and the type of treatments for low back pain vary considerably. Methods In a randomised controlled trial the cost-effectiveness and cost-utility of an intensive group training protocol versus physiotherapy guideline care for sub-acute and chronic low back pain patients is evaluated. Patients with back pain for longer than 6 weeks who are referred to physiotherapy care by their general practitioner or medical specialist are included in the study. The intensive group training protocol combines exercise therapy with principles of behavioural therapy ("graded activity" and back school. This training protocol is compared to physiotherapy care according to the recently published Low Back Pain Guidelines of the Royal Dutch College for Physiotherapy. Primary outcome measures are general improvement, pain intensity, functional status, work absenteeism and quality of life. The direct and indirect costs will be assessed using cost diaries. Patients will complete questionnaires at baseline and 6, 13, 26 and 52 weeks after randomisation. Discussion No trials are yet available that have evaluated the effect of an intensive group training protocol including behavioural principles and back school in a primary physiotherapy care setting and no data on cost-effectiveness and cost-utility are available.

  10. Minimal access surgery compared with medical management for gastro-oesophageal reflux disease: five year follow-up of a randomised controlled trial (REFLUX)

    Science.gov (United States)

    Cotton, S C; Boachie, C; Ramsay, C R; Krukowski, Z H; Heading, R C; Campbell, M K

    2013-01-01

    Objectives To determine the long term clinical effectiveness of laparoscopic fundoplication as an alternative to drug treatment for chronic gastro-oesophageal reflux disease (GORD). Design Five year follow-up of multicentre, pragmatic randomised trial (with parallel non-randomised preference groups). Setting Initial recruitment in 21 UK hospitals. Participants Responders to annual questionnaires among 810 original participants. At entry, all had had GORD for >12 months. Intervention The surgeon chose the type of fundoplication. Medical therapy was reviewed and optimised by a specialist. Subsequent management was at the discretion of the clinician responsible for care, usually in primary care. Main outcome measures Primary outcome measure was self reported quality of life score on disease-specific REFLUX questionnaire. Other measures were health status (with SF-36 and EuroQol EQ-5D questionnaires), use of antireflux medication, and complications. Results By five years, 63% (112/178) of patients randomised to surgery and 13% (24/179) of those randomised to medical management had received a fundoplication (plus 85% (222/261) and 3% (6/192) of those who expressed a preference for surgery and for medical management). Among responders at 5 years, 44% (56/127) of those randomised to surgery were taking antireflux medication versus 82% (98/119) of those randomised to medical management. Differences in the REFLUX score significantly favoured the randomised surgery group (mean difference 8.5 (95% CI 3.9 to 13.1), Preflux-related operations—most often revision of the wrap. Long term rates of dysphagia, flatulence, and inability to vomit were similar in the two randomised groups. Conclusions After five years, laparoscopic fundoplication continued to provide better relief of GORD symptoms than medical management. Adverse effects of surgery were uncommon and generally observed soon after surgery. A small proportion had re-operations. There was no evidence of long term adverse

  11. Post-discharge management following hip fracture - get you back to B4: A parallel group, randomized controlled trial study protocol

    Directory of Open Access Journals (Sweden)

    Brown Roy A

    2011-06-01

    Full Text Available Abstract Background Fall-related hip fractures result in significant personal and societal consequences; importantly, up to half of older adults with hip fracture never regain their previous level of mobility. Strategies of follow-up care for older adults after fracture have improved investigation for osteoporosis; but managing bone health alone is not enough. Prevention of fractures requires management of both bone health and falls risk factors (including the contributing role of cognition, balance and continence to improve outcomes. Methods/Design This is a parallel group, pragmatic randomized controlled trial to test the effectiveness of a post-fracture clinic compared with usual care on mobility for older adults following their hospitalization for hip fracture. Participants randomized to the intervention will attend a fracture follow-up clinic where a geriatrician and physiotherapist will assess and manage their mobility and other health issues. Depending on needs identified at the clinical assessment, participants may receive individualized and group-based outpatient physiotherapy, and a home exercise program. Our primary objective is to assess the effectiveness of a novel post-discharge fracture management strategy on the mobility of older adults after hip fracture. We will enrol 130 older adults (65 years+ who have sustained a hip fracture in the previous three months, and were admitted to hospital from home and are expected to be discharged home. We will exclude older adults who prior to the fracture were: unable to walk 10 meters; diagnosed with dementia and/or significant comorbidities that would preclude their participation in the clinical service. Eligible participants will be randomly assigned to the Intervention or Usual Care groups by remote allocation. Treatment allocation will be concealed; investigators, measurement team and primary data analysts will be blinded to group allocation. Our primary outcome is mobility

  12. GRIN: "GRoup versus INdividual physiotherapy following lower limb intra-muscular Botulinum Toxin-A injections for ambulant children with cerebral palsy: an assessor-masked randomised comparison trial": study protocol.

    Science.gov (United States)

    Thomas, Rachel E; Johnston, Leanne M; Boyd, Roslyn N; Sakzewski, Leanne; Kentish, Megan J

    2014-02-07

    Cerebral palsy is the most common cause of physical disability in childhood. Spasticity is a significant contributor to the secondary impairments impacting functional performance and participation. The most common lower limb spasticity management is focal intramuscular injections of Botulinum Toxin-Type A accompanied by individually-delivered (one on one) physiotherapy rehabilitation. With increasing emphasis on improving goal-directed functional activity and participation within a family-centred framework, it is timely to explore whether physiotherapy provided in a group could achieve comparable outcomes, encouraging providers to offer flexible models of physiotherapy delivery. This study aims to compare individual to group-based physiotherapy following intramuscular Botulinum Toxin-A injections to the lower limbs for ambulant children with cerebral palsy aged four to fourteen years. An assessor-masked, block randomised comparison trial will be conducted with random allocation to either group-based or individual physiotherapy. A sample size of 30 (15 in each study arm) will be recruited. Both groups will receive six hours of direct therapy following Botulinum Toxin-A injections in either an individual or group format with additional home programme activities (three exercises to be performed three times a week). Study groups will be compared at baseline (T1), then at 10 weeks (T2, efficacy) and 26 weeks (T3, retention) post Botulinum Toxin-A injections. Primary outcomes will be caregiver/s perception of and satisfaction with their child's occupational performance goals (Canadian Occupational Performance Measure) and quality of gait (Edinburgh Visual Gait Score) with a range of secondary outcomes across domains of the International Classification of Disability, Functioning and Health. This paper outlines the study protocol including theoretical basis, study hypotheses and outcome measures for this assessor-masked, randomised comparison trial comparing group versus

  13. Pharmacokinetics, safety, and tolerability of varenicline in healthy adolescent smokers: a multicenter, randomized, double-blind, placebo-controlled, parallel-group study.

    Science.gov (United States)

    Faessel, Helene; Ravva, Patanjali; Williams, Kathryn

    2009-01-01

    Varenicline is approved as an aid to smoking cessation in adults aged > or =18 years. The goal of this study was to characterize the multiple-dose pharmacokinetics, safety, and tolerability of varenicline in adolescent smokers. This multicenter, randomized, double-blind, placebo-controlled, parallel-group study enrolled healthy 12- to 16-year-old smokers (> or =3 cigarettes daily) into high-body-weight (>55 kg) and low-body-weight (daily. The apparent renal clearance (CL/F) and volume of distribution (V/F) of varenicline and the effect of body weight on these parameters were estimated using nonlinear mixed-effects modeling. The high-body-weight group consisted of 35 subjects (65.7% male; 77.1% white; mean age, 15.2 years). The low-body-weight group consisted of 37 subjects (37.8% male; 48.6% white; mean age, 14.3 years). The pharmacokinetic parameters of varenicline were dose proportional over the dose range from 0.5 to 2 mg/d. The CL/F for a 70-kg adolescent was 10.4 L/h, comparable to that in a 70-kg adult. The estimated varenicline V/F was decreased in individuals of small body size, thus predicting a varenicline C(max) approximately 30% greater in low-body-weight subjects than in high-body-weight subjects. In high-body-weight subjects, steady-state varenicline exposure, as represented by the AUC(0-24), was 197.0 ng . h/mL for varenicline 1 mg BID and 95.7 ng . h/mL for varenicline 0.5 mg BID, consistent with values reported previously in adult smokers at the equivalent doses. In low-body-weight subjects, varenicline exposure was 126.3 ng . h/mL for varenicline 0.5 mg BID and 60.1 ng . h/mL for varenicline 0.5 mg once daily, values at the lower end of the range observed previously in adults at doses of 1 mg BID and 0.5 mg BID, respectively. Among high-body-weight subjects, adverse events (AEs) were reported by 57.1% of subjects in both the high- and low-dose varenicline groups and by 14.3% of subjects in the placebo group; among low-body-weight subjects, AEs

  14. Feasibility and acceptability of group music therapy vs wait-list control for treatment of patients with long-term depression (the SYNCHRONY trial): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Carr, Catherine Elizabeth; O'Kelly, Julian; Sandford, Stephen; Priebe, Stefan

    2017-03-29

    Depression is of significant global concern. Despite a range of effective treatment options it is estimated that around one in five diagnosed with an acute depressive episode continue to experience enduring symptoms for more than 2 years. There is evidence for effectiveness of individual music therapy for depression. However, no studies have as yet looked at a group intervention within an NHS context. This study aims to assess the feasibility of conducting a randomised controlled trial of group music therapy for patients with long-term depression (symptom durations of 1 year or longer) within the community. This is a single-centre randomised controlled feasibility trial of group music therapy versus wait-list control with a nested process evaluation. Thirty participants will be randomised with unbalanced allocation (20 to receive the intervention immediately, 10 as wait-list controls). Group music therapy will be offered three times per week in a community centre with a focus on songwriting. Data will be collected post-intervention, 3 and 6 months after the intervention finishes. We will examine the feasibility of recruitment processes including identifying the number of eligible participants, participation and retention rates and the intervention in terms of testing components, measuring adherence and estimation of the likely intervention effect. A nested process evaluation will consist of treatment fidelity analysis, exploratory analysis of process measures and end-of-participation interviews with participants and referring staff. Whilst group music therapy is an option in some community mental health settings, this will be the first study to examine group music therapy for this particular patient group. We will assess symptoms of depression, acceptability of the intervention and quality of life. We anticipate potential challenges in the recruitment and retention of participants. It is unclear whether offering the intervention three times per week will be

  15. Effects of Assist-As-Needed Upper Extremity Robotic Therapy after Incomplete Spinal Cord Injury: A Parallel-Group Controlled Trial

    Directory of Open Access Journals (Sweden)

    John Michael Frullo

    2017-06-01

    Full Text Available BackgroundRobotic rehabilitation of the upper limb following neurological injury has been supported through several large clinical studies for individuals with chronic stroke. The application of robotic rehabilitation to the treatment of other neurological injuries is less developed, despite indications that strategies successful for restoration of motor capability following stroke may benefit individuals with incomplete spinal cord injury (SCI as well. Although recent studies suggest that robot-aided rehabilitation might be beneficial after incomplete SCI, it is still unclear what type of robot-aided intervention contributes to motor recovery.MethodsWe developed a novel assist-as-needed (AAN robotic controller to adjust challenge and robotic assistance continuously during rehabilitation therapy delivered via an upper extremity exoskeleton, the MAHI Exo-II, to train independent elbow and wrist joint movements. We further enrolled seventeen patients with incomplete spinal cord injury (AIS C and D levels in a parallel-group balanced controlled trial to test the efficacy of the AAN controller, compared to a subject-triggered (ST controller that does not adjust assistance or challenge levels continuously during therapy. The conducted study is a stage two, development-of-concept pilot study.ResultsWe validated the AAN controller in its capability of modulating assistance and challenge during therapy via analysis of longitudinal robotic metrics. For the selected primary outcome measure, the pre–post difference in ARAT score, no statistically significant change was measured in either group of subjects. Ancillary analysis of secondary outcome measures obtained via robotic testing indicates gradual improvement in movement quality during the therapy program in both groups, with the AAN controller affording greater increases in movement quality over the ST controller.ConclusionThe present study demonstrates feasibility of subject-adaptive robotic therapy

  16. Beyond silence: protocol for a randomized parallel-group trial comparing two approaches to workplace mental health education for healthcare employees.

    Science.gov (United States)

    Moll, Sandra; Patten, Scott Burton; Stuart, Heather; Kirsh, Bonnie; MacDermid, Joy Christine

    2015-04-16

    Mental illness is a significant and growing problem in Canadian healthcare organizations, leading to tremendous personal, social and financial costs for individuals, their colleagues, their employers and their patients. Early and appropriate intervention is needed, but unfortunately, few workers get the help that they need in a timely way due to barriers related to poor mental health literacy, stigma, and inadequate access to mental health services. Workplace education and training is one promising approach to early identification and support for workers who are struggling. Little is known, however, about what approach is most effective, particularly in the context of healthcare work. The purpose of this study is to compare the impact of a customized, contact-based education approach with standard mental health literacy training on the mental health knowledge, stigmatized beliefs and help-seeking/help-outreach behaviors of healthcare employees. A multi-centre, randomized, two-group parallel group trial design will be adopted. Two hundred healthcare employees will be randomly assigned to one of two educational interventions: Beyond Silence, a peer-led program customized to the healthcare workplace, and Mental Health First Aid, a standardized literacy based training program. Pre, post and 3-month follow-up surveys will track changes in knowledge (mental health literacy), attitudes towards mental illness, and help-seeking/help-outreach behavior. An intent-to-treat, repeated measures analysis will be conducted to compare changes in the two groups over time in terms of the primary outcome of behavior change. Linear regression modeling will be used to explore the extent to which knowledge, and attitudes predict behavior change. Qualitative interviews with participants and leaders will also be conducted to examine process and implementation of the programs. This is one of the first experimental studies to compare outcomes of standard mental health literacy training to an

  17. Supporting teachers and children in schools: the effectiveness and cost-effectiveness of the incredible years teacher classroom management programme in primary school children: a cluster randomised controlled trial, with parallel economic and process evaluations

    Directory of Open Access Journals (Sweden)

    Ford Tamsin

    2012-08-01

    Full Text Available Abstract Background Childhood antisocial behaviour has high immediate and long-term costs for society and the individual, particularly in relation to mental health and behaviours that jeopardise health. Managing challenging behaviour is a commonly reported source of stress and burn out among teachers, ultimately resulting in a substantial number leaving the profession. Interventions to improve parenting do not transfer easily to classroom-based problems and the most vulnerable parents may not be easily able to access them. Honing teachers’ skills in proactive behaviour management and the promotion of socio-emotional regulation, therefore, has the potential to improve both child and teacher mental health and well-being and the advantage that it might potentially benefit all the children subsequently taught by any teacher that accesses the training. Methods/Design Cluster randomised controlled trial (RCT of the Incredible Years teacher classroom management (TCM course with combined economic and process evaluations. One teacher of children aged 4–9 years, from 80 schools in the South West Peninsula will be randomised to attend the TCM (intervention arm or to “teach as normal” (control arm. The primary outcome measure will be the total difficulties score from the Strengths and Difficulties Questionnaire (SDQ completed by the current class teachers prior to randomisation, and at 9, 18 and 30 months follow-up, supplemented by parent SDQs. Secondary measures include academic attainment (teacher report supplemented by direct measurement in a sub-sample, children’s enjoyment of school, and teacher reports of their professional self-efficacy, and levels of burn out and stress, supplemented by structured observations of teachers classroom management skills in a subsample. Cost data for the economic evaluation will be based on parental reports of services accessed. Cost-effectiveness, using the SDQ as the measure of effect, will be examined

  18. Supporting teachers and children in schools: the effectiveness and cost-effectiveness of the Incredible Years teacher classroom management programme in primary school children: a cluster randomised controlled trial, with parallel economic and process evaluations.

    Science.gov (United States)

    Ford, Tamsin; Edwards, Vanessa; Sharkey, Siobhan; Ukoumunne, Obioha C; Byford, Sarah; Norwich, Brahm; Logan, Stuart

    2012-08-30

    Childhood antisocial behaviour has high immediate and long-term costs for society and the individual, particularly in relation to mental health and behaviours that jeopardise health. Managing challenging behaviour is a commonly reported source of stress and burn out among teachers, ultimately resulting in a substantial number leaving the profession. Interventions to improve parenting do not transfer easily to classroom-based problems and the most vulnerable parents may not be easily able to access them. Honing teachers' skills in proactive behaviour management and the promotion of socio-emotional regulation, therefore, has the potential to improve both child and teacher mental health and well-being and the advantage that it might potentially benefit all the children subsequently taught by any teacher that accesses the training. Cluster randomised controlled trial (RCT) of the Incredible Years teacher classroom management (TCM) course with combined economic and process evaluations.One teacher of children aged 4-9 years, from 80 schools in the South West Peninsula will be randomised to attend the TCM (intervention arm) or to "teach as normal" (control arm). The primary outcome measure will be the total difficulties score from the Strengths and Difficulties Questionnaire (SDQ) completed by the current class teachers prior to randomisation, and at 9, 18 and 30 months follow-up, supplemented by parent SDQs. Secondary measures include academic attainment (teacher report supplemented by direct measurement in a sub-sample), children's enjoyment of school, and teacher reports of their professional self-efficacy, and levels of burn out and stress, supplemented by structured observations of teachers classroom management skills in a subsample. Cost data for the economic evaluation will be based on parental reports of services accessed. Cost-effectiveness, using the SDQ as the measure of effect, will be examined over the period of the RCT and over the longer term using decision

  19. randomised trial of alternative malaria chemoprophylaxis strategies

    African Journals Online (AJOL)

    hi-tech

    2000-02-02

    Feb 2, 2000 ... randomisation produced comparable intervention and comparison groups with balanced characteristics. Specific results of the baseline studies are presented in the companion paper. ... strategies for protecting pregnant women against malaria. ..... from malaria vaccine trial conducted among Tanzanian.

  20. Trial protocol: a parallel group, individually randomized clinical trial to evaluate the effect of a mobile phone application to improve sexual health among youth in Stockholm County.

    Science.gov (United States)

    Nielsen, Anna; De Costa, Ayesha; Bågenholm, Aspasia; Danielsson, Kristina Gemzell; Marrone, Gaetano; Boman, Jens; Salazar, Mariano; Diwan, Vinod

    2018-02-05

    Genital Chlamydia trachomatis infection is a major public health problem worldwide affecting mostly youth. Sweden introduced an opportunistic screening approach in 1982 accompanied by treatment, partner notification and case reporting. After an initial decline in infection rate till the mid-90s, the number of reported cases has increased over the last two decades and has now stabilized at a high level of 37,000 reported cases in Sweden per year (85% of cases in youth). Sexual risk-taking among youth is also reported to have significantly increased over the last 20 years. Mobile health (mHealth) interventions could be particularly suitable for youth and sexual health promotion as the intervention is delivered in a familiar and discrete way to a tech savvy at-risk population. This paper presents a protocol for a randomized trial to study the effect of an interactive mHealth application (app) on condom use among the youth of Stockholm. 446 youth resident in Stockholm, will be recruited in this two arm parallel group individually randomized trial. Recruitment will be from Youth Health Clinics or via the trial website. Participants will be randomized to receive either the intervention (which comprises an interactive app on safe sexual health that will be installed on their smart phones) or a control group (standard of care). Youth will be followed up for 6 months, with questionnaire responses submitted periodically via the app. Self-reported condom use over 6 months will be the primary outcome. Secondary outcomes will include presence of an infection, Chlamydia tests during the study period and proxy markers of safe sex. Analysis is by intention to treat. This trial exploits the high mobile phone usage among youth to provide a phone app intervention in the area of sexual health. If successful, the results will have implications for health service delivery and health promotion among the youth. From a methodological perspective, this trial is expected to provide

  1. Effects of policosanol on borderline to mildly elevated serum total cholesterol levels: a prospective, double-blind, placebo-controlled, parallel-group, comparative study

    Directory of Open Access Journals (Sweden)

    Gladys Castaño, PhD

    2003-09-01

    Full Text Available Background: Hypercholesterolemia is a major risk factor for coronary heart disease. Clinical studies have shown that lowering elevated serum cholesterol levels, particularly low-density lipoprotein cholesterol (LDL-C, is beneficial for patients with borderline to mildly elevated serum total cholesterol (TC levels (5.0–6.0 mmol/L. Policosanol is a cholesterol-lowering drug made from purified sugar cane wax. The therapeutic range of policosanol is 5 to 20 mg/d. Objective: This study investigated the efficacy and tolerability of policosanol 5 mg/d in patients with borderline to mildly elevated serum TC levels. Methods: This 14-week, single-center, prospective, double-blind, placebo-controlled, parallel-group, comparative study was conducted in men and women aged 25 to 75 years with a serum TC level ≥4.8 to <6.0 mmol/L. After a 6-week run-in period in which patients were placed on therapeutic lifestyle changes, in particular a cholesterol-lowering diet, patients were randomly assigned to receive policosanol 5-mg tablets or placebo tablets once daily with the evening meal for 8 weeks, and the diet was continued throughout the study. Lipid profile variables, safety indicators, adverse events (AEs, and compliance with study medications were assessed. Results: One hundred patients (71 women, 29 men; mean [SD] age, 52 [10] years entered the study after the dietary run-in period. After 8 weeks of treatment, the mean (SD serum LDL-C level decreased significantly in the policosanol group (P<0.001 vs baseline and placebo from 3.57 (0.30 mmol/L to 2.86 (0.41 mmol/L (change, −19.9%. Significantly more patients in the policosanol group (42 patients [84%] achieved a ≥15% decrease in serum LDL-C than in the placebo group (2 patients [4%] (P<0.001. Also in the policosanol group, the mean (SD serum TC level decreased significantly, from 5.20 (0.22 mmol/L to 4.56 (0.44 mmol/L (P<0.001 vs baseline and placebo (change, −12.3%; the mean (SD triglyceride (TG

  2. Adjuvant chemotherapy with 5-fluorouracil, L-folinic acid and levamisole for patients with colorectal cancer: non-randomised comparison of weekly versus four-weekly schedules--less pain, same gain. QUASAR Colorectal Cancer Study Group.

    Science.gov (United States)

    Kerr, D J; Gray, R; McConkey, C; Barnwell, J

    2000-08-01

    QUASAR is a large trial of adjuvant chemotherapy for colorectal cancer in which clinicians could choose to deliver a standard adjuvant cytotoxic chemotherapy regimen, 5-fluorouracil (5-FU) and L-folinic acid (L-FA), in either a once-weekly or a four-weekly schedule. We report results of a non-randomised comparison between these schedules with respect to survival, recurrence and differential toxicity. In a factorial (2 x 2) trial design, QUASAR compared high-dose (175 mg) versus low-dose (25 mg) L-FA and levamisole versus placebo. The dose of 5-FU was fixed at 370 mg/m2 and although the recommended schedule was i.v. bolus delivery, daily for 5 days repeated four-weekly for 6 months, a significant proportion of randomising clinicians were constrained to deliver once-weekly 5-FU-L-FA for 30 weeks. Four thousand nine hundred twenty-seven patients were entered into QUASAR between May 1994 and October 1997, eighteen hundred twenty-nine of whom have recurred and sixteen hundred eighty-nine died. Similar numbers 2370 vs. 2559 were treated with the once-weekly and four-weekly schedules and the demographic features of the 2 groups were well balanced: stage C, 73.3% once-weekly vs. 71.0% four-weekly; colon, 68.0% vs. 68.3%; high-dose FA, 50.1% vs. 49.9%; levamisole, 49.3% vs. 49.3%; females, 40.2% vs. 41.7%; median age (years) 62 vs. 61. The risk of recurrence and survival were similar regardless of schedule: three-year survival was 70.6% once-weekly vs. 71.0% four-weekly; three-year recurrence risk was 35.6% once-weekly vs. 35.5% four-weekly; But, the once-weekly regimen was much less toxic: number of patients for whom toxicity was reported (once-weekly: four-weekly), stomatitis, 37 vs. 337; diarrhoea, 260 vs. 440; neutropenia, 20 vs. 153. The once-weekly regimen is much less toxic than and, apparently, about as effective as the four-weekly schedule. This suggests that the toxicity of 5-FU-L-FA adjuvant chemotherapy could be reduced substantially by weekly scheduling without

  3. Duloxetine for the management of diabetic peripheral neuropathic pain: evidence-based findings from post hoc analysis of three multicenter, randomized, double-blind, placebo-controlled, parallel-group studies

    DEFF Research Database (Denmark)

    Kajdasz, Daniel K; Iyengar, Smriti; Desaiah, Durisala

    2007-01-01

    peripheral neuropathic pain (DPNP). METHODS: Data were pooled from three 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies in which patients received 60 mg duloxetine either QD or BID or placebo. NNT was calculated based on rates of response (defined as >or=30...

  4. Theory-driven group-based complex intervention to support self-management of osteoarthritis and low back pain in primary care physiotherapy: protocol for a cluster randomised controlled feasibility trial (SOLAS).

    Science.gov (United States)

    Hurley, Deirdre A; Hall, Amanda M; Currie-Murphy, Laura; Pincus, Tamar; Kamper, Steve; Maher, Chris; McDonough, Suzanne M; Lonsdale, Chris; Walsh, Nicola E; Guerin, Suzanne; Segurado, Ricardo; Matthews, James

    2016-01-21

    International clinical guidelines consistently endorse the promotion of self-management (SM), including physical activity for patients with chronic low back pain (CLBP) and osteoarthritis (OA). Patients frequently receive individual treatment and advice to self-manage from physiotherapists in primary care, but the successful implementation of a clinical and cost-effective group SM programme is a key priority for health service managers in Ireland to maximise long-term outcomes and efficient use of limited and costly resources. This protocol describes an assessor-blinded cluster randomised controlled feasibility trial of a group-based education and exercise intervention underpinned by self-determination theory designed to support an increase in SM behaviour in patients with CLBP and OA in primary care physiotherapy. The primary care clinic will be the unit of randomisation (cluster), with each clinic randomised to 1 of 2 groups providing the Self-management of Osteoarthritis and Low back pain through Activity and Skills (SOLAS) intervention or usual individual physiotherapy. Patients are followed up at 6 weeks, 2 and 6 months. The primary outcomes are the (1) acceptability and demand of the intervention to patients and physiotherapists, (2) feasibility and optimal study design/procedures and sample size for a definitive trial. Secondary outcomes include exploratory analyses of: point estimates, 95% CIs, change scores and effect sizes in physical function, pain and disability outcomes; process of change in target SM behaviours and selected mediators; and the cost of the intervention to inform a definitive trial. This feasibility trial protocol was approved by the UCD Human Research Ethics-Sciences Committee (LS-13-54 Currie-Hurley) and research access has been granted by the Health Services Executive Primary Care Research Committee in January 2014. The study findings will be disseminated to the research, clinical and health service communities through publication in

  5. Parallel computation

    International Nuclear Information System (INIS)

    Jejcic, A.; Maillard, J.; Maurel, G.; Silva, J.; Wolff-Bacha, F.

    1997-01-01

    The work in the field of parallel processing has developed as research activities using several numerical Monte Carlo simulations related to basic or applied current problems of nuclear and particle physics. For the applications utilizing the GEANT code development or improvement works were done on parts simulating low energy physical phenomena like radiation, transport and interaction. The problem of actinide burning by means of accelerators was approached using a simulation with the GEANT code. A program of neutron tracking in the range of low energies up to the thermal region has been developed. It is coupled to the GEANT code and permits in a single pass the simulation of a hybrid reactor core receiving a proton burst. Other works in this field refers to simulations for nuclear medicine applications like, for instance, development of biological probes, evaluation and characterization of the gamma cameras (collimators, crystal thickness) as well as the method for dosimetric calculations. Particularly, these calculations are suited for a geometrical parallelization approach especially adapted to parallel machines of the TN310 type. Other works mentioned in the same field refer to simulation of the electron channelling in crystals and simulation of the beam-beam interaction effect in colliders. The GEANT code was also used to simulate the operation of germanium detectors designed for natural and artificial radioactivity monitoring of environment

  6. Cognitive-behavioural therapy (CBT) for renal fatigue (BReF):a feasibility randomised-controlled trial of CBT for the management of fatigue in haemodialysis (HD) patients

    OpenAIRE

    Picariello, Federica; Moss-Morris, Rona; Macdougall, Iain C.; Norton, Sam; Da Silva-Gane, Maria; Farrington, Ken; Clayton, Hope; Chilcot, Joseph

    2018-01-01

    Introduction Fatigue is one of the most common and disabling symptoms in end-stage kidney disease, particularly among in-centre haemodialysis patients. This two-arm parallel group feasibility randomised controlled trial will determine whether a fully powered efficacy trial is achievable by examining the feasibility of recruitment, acceptability and potential benefits of a cognitive-behavioural therapy (CBT)-based intervention for fatigue among in-centre haemodialysis patients.Methods We aim t...

  7. Effectiveness of a guided self-help manual in strengthening resilience in people diagnosed with moderate depression and their family caregivers in Thailand: a randomised controlled trial

    OpenAIRE

    McCann, Terence; Songprakun, Wallapa; Stephenson, John

    2017-01-01

    The growing incidence of depression in developing countries, such as Thailand, is placing increasing pressure on public mental health services, and those living in rural areas have limited access to mental health services and specialised support. Resilience is integral to the recovery of people with depression and to caregivers. This parallel group randomised controlled trial evaluated the effectiveness of a guided self-help manual in improving resilience in adults diagnosed with moderate dep...

  8. Community mobilisation with women's groups facilitated by Accredited Social Health Activists (ASHAs to improve maternal and newborn health in underserved areas of Jharkhand and Orissa: study protocol for a cluster-randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Sinha Rajesh

    2011-07-01

    Full Text Available Abstract Background Around a quarter of the world's neonatal and maternal deaths occur in India. Morbidity and mortality are highest in rural areas and among the poorest wealth quintiles. Few interventions to improve maternal and newborn health outcomes with government-mandated community health workers have been rigorously evaluated at scale in this setting. The study aims to assess the impact of a community mobilisation intervention with women's groups facilitated by ASHAs to improve maternal and newborn health outcomes among rural tribal communities of Jharkhand and Orissa. Methods/design The study is a cluster-randomised controlled trial and will be implemented in five districts, three in Jharkhand and two in Orissa. The unit of randomisation is a rural cluster of approximately 5000 population. We identified villages within rural, tribal areas of five districts, approached them for participation in the study and enrolled them into 30 clusters, with approximately 10 ASHAs per cluster. Within each district, 6 clusters were randomly allocated to receive the community intervention or to the control group, resulting in 15 intervention and 15 control clusters. Randomisation was carried out in the presence of local stakeholders who selected the cluster numbers and allocated them to intervention or control using a pre-generated random number sequence. The intervention is a participatory learning and action cycle where ASHAs support community women's groups through a four-phase process in which they identify and prioritise local maternal and newborn health problems, implement strategies to address these and evaluate the result. The cycle is designed to fit with the ASHAs' mandate to mobilise communities for health and to complement their other tasks, including increasing institutional delivery rates and providing home visits to mothers and newborns. The trial's primary endpoint is neonatal mortality during 24 months of intervention. Additional

  9. Parallel R

    CERN Document Server

    McCallum, Ethan

    2011-01-01

    It's tough to argue with R as a high-quality, cross-platform, open source statistical software product-unless you're in the business of crunching Big Data. This concise book introduces you to several strategies for using R to analyze large datasets. You'll learn the basics of Snow, Multicore, Parallel, and some Hadoop-related tools, including how to find them, how to use them, when they work well, and when they don't. With these packages, you can overcome R's single-threaded nature by spreading work across multiple CPUs, or offloading work to multiple machines to address R's memory barrier.

  10. The ANU WellBeing study: a protocol for a quasi-factorial randomised controlled trial of the effectiveness of an Internet support group and an automated Internet intervention for depression

    Directory of Open Access Journals (Sweden)

    Mackinnon Andrew J

    2010-03-01

    Full Text Available Abstract Background Recent projections suggest that by the year 2030 depression will be the primary cause of disease burden among developed countries. Delivery of accessible consumer-focused evidenced-based services may be an important element in reducing this burden. Many consumers report a preference for self-help modes of delivery. The Internet offers a promising modality for delivering such services and there is now evidence that automated professionally developed self-help psychological interventions can be effective. By contrast, despite their popularity, there is little evidence as to the effectiveness of Internet support groups which provide peer-to-peer mutual support. Methods/Design Members of the community with elevated psychological distress were randomised to receive one of the following: (1 Internet Support Group (ISG intervention, (2 a multi-module automated psychoeducational and skills Internet Training Program (ITP, (3 a combination of the ISG and ITP, or (4 an Internet Attention Control website (IAC comprising health and wellbeing information and question and answer modules. Each intervention was 12 weeks long. Assessments were conducted at baseline, post-intervention, 6 and 12 months to examine depressive symptoms, social support, self-esteem, quality of life, depression literacy, stigma and help-seeking for depression. Participants were recruited through a screening postal survey sent to 70,000 Australians aged 18 to 65 years randomly selected from four rural and four metropolitan regions in Australia. Discussion To our knowledge this study is the first randomised controlled trial of the effectiveness of a depression ISG. Trial registration Current Controlled Trials ISRCTN65657330.

  11. Vinorelbine and gemcitabine vs vinorelbine and carboplatin as first-line treatment of advanced NSCLC. A phase III randomised controlled trial by the Norwegian Lung Cancer Study Group

    DEFF Research Database (Denmark)

    Fløtten, Ø; Grønberg, B H; Bremnes, R

    2012-01-01

    BACKGROUND: Platinum-based doublet chemotherapy is the standard first-line treatment for advanced non-small cell lung cancer (NSCLC), but earlier studies have suggested that non-platinum combinations are equally effective and better tolerated. We conducted a national, randomised study to compare...... a non-platinum with a platinum combination. METHODS: Eligible patients had stage IIIB/IV NSCLC and performance status (PS) 0-2. Patients received up to three cycles of vinorelbine 60 mg m(-2) p.o.+gemcitabine 1000 mg m(-2) i.v. day 1 and 8 (VG) or vinorelbine 60 mg m(-2) p.o. day 1 and 8+carboplatin...... was 65 years, 58% were men and 25% had PS 2. Median survival was VG: 6.3 months; VC: 7.0 months, P=0.802. Vinorelbine plus carboplatin patients had more grade III/IV nausea/vomiting (VG: 4%, VC: 12%, P=0.008) and grade IV neutropenia (VG: 7%, VC: 19%, P

  12. 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...

  13. Intensive speech and language therapy in patients with chronic aphasia after stroke: a randomised, open-label, blinded-endpoint, controlled trial in a health-care setting:A randomised, open-label, blinded-endpoint, controlled trial in a health-care setting

    OpenAIRE

    Caterina, Breitenstein; Grewe, Tanja; Flöel, Agnes; Ziegler, Wolfram; Springer, Luise; Martus, Peter; Huber, Walter; Willmes, Klaus; Ringelstein, E. Bernd; Haeusler, Karl Georg; Abel, Steffie; Glindemann, Ralf; Domahs, Frank; Regenbrecht, Frank; Schlenck, Klaus-Jürgen

    2017-01-01

    BackgroundTreatment guidelines for aphasia recommend intensive speech and language therapy for chronic (≥6 months) aphasia after stroke, but large-scale, class 1 randomised controlled trials on treatment effectiveness are scarce. We aimed to examine whether 3 weeks of intensive speech and language therapy under routine clinical conditions improved verbal communication in daily-life situations in people with chronic aphasia after stroke.MethodsIn this multicentre, parallel group, superiority, ...

  14. Parallel Lines

    Directory of Open Access Journals (Sweden)

    James G. Worner

    2017-05-01

    Full Text Available James Worner is an Australian-based writer and scholar currently pursuing a PhD at the University of Technology Sydney. His research seeks to expose masculinities lost in the shadow of Australia’s Anzac hegemony while exploring new opportunities for contemporary historiography. He is the recipient of the Doctoral Scholarship in Historical Consciousness at the university’s Australian Centre of Public History and will be hosted by the University of Bologna during 2017 on a doctoral research writing scholarship.   ‘Parallel Lines’ is one of a collection of stories, The Shapes of Us, exploring liminal spaces of modern life: class, gender, sexuality, race, religion and education. It looks at lives, like lines, that do not meet but which travel in proximity, simultaneously attracted and repelled. James’ short stories have been published in various journals and anthologies.

  15. Factors associated with study attrition in a pilot randomised controlled trial to explore the role of exercise-assisted reduction to stop (EARS) smoking in disadvantaged groups.

    Science.gov (United States)

    Thompson, T P; Greaves, C J; Ayres, R; Aveyard, P; Warren, F C; Byng, R; Taylor, R S; Campbell, J L; Ussher, M; Michie, S; West, R; Taylor, A H

    2016-10-27

    Study attrition has the potential to compromise a trial's internal and external validity. The aim of the present study was to identify factors associated with participant attrition in a pilot trial of the effectiveness of a novel behavioural support intervention focused on increasing physical activity to reduce smoking, to inform the methods to reduce attrition in a definitive trial. Disadvantaged smokers who wanted to reduce but not quit were randomised (N = 99), of whom 61 (62 %) completed follow-up assessments at 16 weeks. Univariable logistic regression was conducted to determine the effects of intervention arm, method of recruitment, and participant characteristics (sociodemographic factors, and lifestyle, behavioural and attitudinal characteristics) on attrition, followed by multivariable logistic regression on those factors found to be related to attrition. Participants with low confidence to quit, and who were undertaking less than 150 mins of moderate and vigorous physical activity per week at baseline were less likely to complete the 16-week follow-up assessment. Exploratory analysis revealed that those who were lost to follow-up early in the trial (i.e., by 4 weeks), compared with those completing the study, were younger, had smoked for fewer years and had lower confidence to quit in the next 6 months. Participants who recorded a higher expired air carbon monoxide reading at baseline were more likely to drop out late in the study, as were those recruited via follow-up telephone calls. Multivariable analyses showed that only completing less than 150 mins of physical activity retained any confidence in predicting attrition in the presence of other variables. The findings indicate that those who take more effort to be recruited, are younger, are heavier smokers, have less confidence to quit, and are less physically active are more likely to withdraw or be lost to follow-up.

  16. Comparison of fluorouracil with additional levamisole, higher-dose folinic acid, or both, as adjuvant chemotherapy for colorectal cancer: a randomised trial. QUASAR Collaborative Group.

    Science.gov (United States)

    2000-05-06

    Standard adjuvant chemotherapy for colorectal cancer consists of fluorouracil with folinic acid or levamisole. The large QUASAR randomised trial aimed to investigate (in a two x two design) whether use of a higher dose of folinic acid or addition of levamisole to fluorouracil and folinic acid improved survival. Patients with colorectal cancer, without evident residual disease, were randomly assigned fluorouracil (370 mg/m2) with high-dose (175 mg) or low-dose (25 mg) L-folinic acid and either active or placebo levamisole. The fluorouracil and folinic acid could be given either as six 5-day courses with 4 weeks between the start of the courses or as 30 once-weekly doses. Levamisole (50 mg) or placebo was given three times daily for 3 days repeated every 2 weeks for 12 courses. The primary endpoint was mortality from any cause. Analyses were by intention to treat. Between 1994 and 1997, 4,927 patients were enrolled. 1,776 had recurrences and 1,576 died. Survival was similar with high-dose and low-dose folinic acid (70.1% vs 71.0% at 3 years; p=0-43), as were 3-year recurrence rates (36.0% vs 35.8%; p=0.94). Survival was worse with levamisole than with placebo (69.4% vs 71.5% at 3 years; p=0.06), and there were more recurrences with the active drug (37.0% vs 34.9% at 3 years; p=0.16). The inclusion of levamisole in chemotherapy regimens for colorectal cancer does not delay recurrence or improve survival. Higher-dose folinic acid produced no extra benefit in these regimens over that from low-dose folinic acid. Trials of chemotherapy versus no chemotherapy will show whether these four treatments are equally effective or equally ineffective.

  17. A pragmatic group sequential, placebo-controlled, randomised trial to determine the effectiveness of glyceryl trinitrate for retained placenta (GOT-IT): a study protocol.

    Science.gov (United States)

    Denison, Fiona C; Norrie, John; Lawton, Julia; Norman, Jane E; Scotland, Graham; McPherson, Gladys C; McDonald, Alison; Forrest, Mark; Hudson, Jemma; Brewin, Jane; Peace, Mathilde; Clarkson, Cynthia; Brook-Smith, Sheonagh; Morrow, Susan; Hallowell, Nina; Hodges, Laura; Carruthers, Kathryn F

    2017-09-18

    A retained placenta is diagnosed when the placenta is not delivered following delivery of the baby. It is a major cause of postpartum haemorrhage and treated by the operative procedure of manual removal of placenta (MROP). The aim of this pragmatic, randomised, placebo-controlled, double-blind UK-wide trial, with an internal pilot and nested qualitative research to adjust strategies to refine delivery of the main trial, is to determine whether sublingual glyceryl trinitrate (GTN) is (or is not) clinically and cost-effective for (medical) management of retained placenta. The primary clinical outcome is need for MROP, defined as the placenta remaining undelivered 15 min poststudy treatment and/or being required within 15 min of treatment due to safety concerns. The primary safety outcome is measured blood loss between administration of treatment and transfer to the postnatal ward or other clinical area. The primary patient-sided outcome is satisfaction with treatment and a side effect profile. The primary economic outcome is net incremental costs (or cost savings) to the National Health Service of using GTN versus standard practice. Secondary outcomes are being measured over a range of clinical and economic domains. The primary outcomes will be analysed using linear models appropriate to the distribution of each outcome. Health service costs will be compared with multiple trial outcomes in a cost-consequence analysis of GTN versus standard practice. Ethical approval has been obtained from the North-East Newcastle & North Tyneside 2 Research Ethics Committee (13/NE/0339). Dissemination plans for the trial include the Health Technology Assessment Monograph, presentation at international scientific meetings and publication in high-impact, peer-reviewed journals. ISCRTN88609453; Pre-results. © 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

  18. Rationale and design of the ranolazine PH-RV study: a multicentred randomised and placebo-controlled study of ranolazine to improve RV function in patients with non-group 2 pulmonary hypertension.

    Science.gov (United States)

    Han, Yuchi; Forfia, Paul R; Vaidya, Anjali; Mazurek, Jeremy A; Park, Myung H; Ramani, Gautam; Chan, Stephen Y; Waxman, Aaron B

    2018-01-01

    A major determining factor on outcomes in patients with pulmonary arterial hypertension (PAH) is right ventricular (RV) function. Ranolazine, which is currently approved for chronic stable angina, has been shown to improve RV function in an animal model and has been shown to be safe in small human studies with PAH. We aim to study the effect of ranolazine on RV function using cardiovascular magnetic resonance (CMR) in patients with pulmonary hypertension (non-group 2 patients) and monitor the effect of ranolazine on metabolism using metabolic profiling and changes of microRNA. This study is a longitudinal, randomised, double-blind, placebo-controlled, multicentre proof-of-concept study in 24 subjects with pulmonary hypertension and RV dysfunction treated with ranolazine over 6 months. Subjects who meet the protocol definition of RV dysfunction (CMR RV ejection fraction (EF) <45%) will be randomised to ranolazine or placebo with a ratio of 2:1. Enrolled subjects will be assessed for functional class, 6 min walk test and health outcome based on SF-36 tool. Peripheral blood will be obtained for N-terminal-pro brain natriuretic peptide, metabolic profiling, and microRNA at baseline and the conclusion of the treatment period. CMR will be performed at baseline and the conclusion of the treatment period. The primary outcome is change in RVEF. The exploratory outcomes include clinical, other CMR parameters, metabolic and microRNA changes. The trial protocol was approved by Institutional Review Boards. The trial findings will be disseminated in scientific journals and meetings. NCT01839110 and NCT02829034; Pre-results.

  19. Programs Lucky and LuckyC - 3D parallel transport codes for the multi-group transport equation solution for XYZ geometry by Pm Sn method

    International Nuclear Information System (INIS)

    Moriakov, A.; Vasyukhno, V.; Netecha, M.; Khacheresov, G.

    2003-01-01

    Powerful supercomputers are available today. MBC-1000M is one of Russian supercomputers that may be used by distant way access. Programs LUCKY and LUCKY C were created to work for multi-processors systems. These programs have algorithms created especially for these computers and used MPI (message passing interface) service for exchanges between processors. LUCKY may resolved shielding tasks by multigroup discreet ordinate method. LUCKY C may resolve critical tasks by same method. Only XYZ orthogonal geometry is available. Under little space steps to approximate discreet operator this geometry may be used as universal one to describe complex geometrical structures. Cross section libraries are used up to P8 approximation by Legendre polynomials for nuclear data in GIT format. Programming language is Fortran-90. 'Vector' processors may be used that lets get a time profit up to 30 times. But unfortunately MBC-1000M has not these processors. Nevertheless sufficient value for efficiency of parallel calculations was obtained under 'space' (LUCKY) and 'space and energy' (LUCKY C ) paralleling. AUTOCAD program is used to control geometry after a treatment of input data. Programs have powerful geometry module, it is a beautiful tool to achieve any geometry. Output results may be processed by graphic programs on personal computer. (authors)

  20. Randomised study of sequential versus combination chemotherapy with capecitabine, irinotecan and oxaliplatin in advanced colorectal cancer, an interim safety analysis. A Dutch Colorectal Cancer Group (DCCG) phase III study.

    NARCIS (Netherlands)

    Koopman, M.; Antonini, N.; Douma, J.; Wals, J.; Honkoop, A.H.; Erdkamp, F.L.; Jong, R.S. de; Rodenburg, C.J.; Vreugdenhil, G.R.; Akkermans-Vogelaar, J.M.; Punt, C.J.A.

    2006-01-01

    BACKGROUND: Results on overall survival in randomised studies of mono- versus combination chemotherapy in advanced colorectal cancer patients may have been biased by an imbalance in salvage treatments. This is the first randomised study that evaluates sequential versus combination chemotherapy with

  1. Randomised study of sequential versus combination chemotherapy with capecitabine, irinotecan and oxaliplatin in advanced colorectal cancer, an interim safety analysis. A Dutch Colorectal Cancer Group (DCCG) phase III study

    NARCIS (Netherlands)

    Koopman, M.; Antonini, N. F.; Douma, J.; Wals, J.; Honkoop, A. H.; Erdkamp, F. L. G.; de Jong, R. S.; Rodenburg, C. J.; Vreugdenhil, G.; Akkermans-Vogelaar, J. M.; Punt, C. J. A.

    2006-01-01

    Results on overall survival in randomised studies of mono- versus combination chemotherapy in advanced colorectal cancer patients may have been biased by an imbalance in salvage treatments. This is the first randomised study that evaluates sequential versus combination chemotherapy with a

  2. A randomised controlled trial evaluating a rehabilitation complex intervention for patients following intensive care discharge: the RECOVER study

    Science.gov (United States)

    Salisbury, Lisa G; Boyd, Julia; Ramsay, Pamela; Merriweather, Judith; Huby, Guro; Forbes, John; Rattray, Janice Z; Griffith, David M; Mackenzie, Simon J; Hull, Alastair; Lewis, Steff; Murray, Gordon D

    2012-01-01

    Introduction Patients who survive an intensive care unit admission frequently suffer physical and psychological morbidity for many months after discharge. Current rehabilitation pathways are often fragmented and little is known about the optimum method of promoting recovery. Many patients suffer reduced quality of life. Methods and analysis The authors plan a multicentre randomised parallel group complex intervention trial with concealment of group allocation from outcome assessors. Patients who required more than 48 h of mechanical ventilation and are deemed fit for intensive care unit discharge will be eligible. Patients with primary neurological diagnoses will be excluded. Participants will be randomised into one of the two groups: the intervention group will receive standard ward-based care delivered by the NHS service with additional treatment by a specifically trained generic rehabilitation assistant during ward stay and via telephone contact after hospital discharge and the control group will receive standard ward-based care delivered by the current NHS service. The intervention group will also receive additional information about their critical illness and access to a critical care physician. The total duration of the intervention will be from randomisation to 3 months postrandomisation. The total duration of follow-up will be 12 months from randomisation for both groups. The primary outcome will be the Rivermead Mobility Index at 3 months. Secondary outcomes will include measures of physical and psychological morbidity and function, quality of life and survival over a 12-month period. A health economic evaluation will also be undertaken. Groups will be compared in relation to primary and secondary outcomes; quantitative analyses will be supplemented by focus groups with patients, carers and healthcare workers. Ethics and dissemination Consent will be obtained from patients and relatives according to patient capacity. Data will be analysed according

  3. Sample size calculations for cluster randomised crossover trials in Australian and New Zealand intensive care research.

    Science.gov (United States)

    Arnup, Sarah J; McKenzie, Joanne E; Pilcher, David; Bellomo, Rinaldo; Forbes, Andrew B

    2018-06-01

    The cluster randomised crossover (CRXO) design provides an opportunity to conduct randomised controlled trials to evaluate low risk interventions in the intensive care setting. Our aim is to provide a tutorial on how to perform a sample size calculation for a CRXO trial, focusing on the meaning of the elements required for the calculations, with application to intensive care trials. We use all-cause in-hospital mortality from the Australian and New Zealand Intensive Care Society Adult Patient Database clinical registry to illustrate the sample size calculations. We show sample size calculations for a two-intervention, two 12-month period, cross-sectional CRXO trial. We provide the formulae, and examples of their use, to determine the number of intensive care units required to detect a risk ratio (RR) with a designated level of power between two interventions for trials in which the elements required for sample size calculations remain constant across all ICUs (unstratified design); and in which there are distinct groups (strata) of ICUs that differ importantly in the elements required for sample size calculations (stratified design). The CRXO design markedly reduces the sample size requirement compared with the parallel-group, cluster randomised design for the example cases. The stratified design further reduces the sample size requirement compared with the unstratified design. The CRXO design enables the evaluation of routinely used interventions that can bring about small, but important, improvements in patient care in the intensive care setting.

  4. 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

  5. Randomised study of Casodex 50 MG monotherapy vs orchidectomy in the treatment of metastatic prostate cancer. The Scandinavian Casodex Cooperative Group

    DEFF Research Database (Denmark)

    Iversen, P; Tveter, K; Varenhorst, E

    1996-01-01

    % in the orchidectomy group. Treatment failed in 51 patients in the orchidectomy group and 66 showed a subjective response. Treatment failed in 86 patients treated with Casodex and 40 patients showed a subjective response. Patients treated with Casodex maintained their sexual interest better than those...

  6. Group-based antenatal birth and parent preparation for improving birth outcomes and parenting resources: Study protocol for a randomised trial

    DEFF Research Database (Denmark)

    Koushede, Vibeke; Brixval, Carina Sjöberg; Axelsen, Solveig Forberg

    2013-01-01

    To examine the efficacy and cost-effectiveness of group based antenatal education for improving childbirth and parenting resources compared to auditorium based education.......To examine the efficacy and cost-effectiveness of group based antenatal education for improving childbirth and parenting resources compared to auditorium based education....

  7. 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.

  8. Exploiting Symmetry on Parallel Architectures.

    Science.gov (United States)

    Stiller, Lewis Benjamin

    1995-01-01

    This thesis describes techniques for the design of parallel programs that solve well-structured problems with inherent symmetry. Part I demonstrates the reduction of such problems to generalized matrix multiplication by a group-equivariant matrix. Fast techniques for this multiplication are described, including factorization, orbit decomposition, and Fourier transforms over finite groups. Our algorithms entail interaction between two symmetry groups: one arising at the software level from the problem's symmetry and the other arising at the hardware level from the processors' communication network. Part II illustrates the applicability of our symmetry -exploitation techniques by presenting a series of case studies of the design and implementation of parallel programs. First, a parallel program that solves chess endgames by factorization of an associated dihedral group-equivariant matrix is described. This code runs faster than previous serial programs, and discovered it a number of results. Second, parallel algorithms for Fourier transforms for finite groups are developed, and preliminary parallel implementations for group transforms of dihedral and of symmetric groups are described. Applications in learning, vision, pattern recognition, and statistics are proposed. Third, parallel implementations solving several computational science problems are described, including the direct n-body problem, convolutions arising from molecular biology, and some communication primitives such as broadcast and reduce. Some of our implementations ran orders of magnitude faster than previous techniques, and were used in the investigation of various physical phenomena.

  9. Assessing the impact of bibliographical support on the quality of medical care in patients admitted to an internal medicine service: a prospective clinical, open, randomised two-arm parallel study.

    Science.gov (United States)

    Pastori, Matteo Mario; Sarti, Manuela; Pons, Marco; Barazzoni, Fabrizio

    2014-10-01

    To assess and quantify the impact of the literature in diagnostic decisions and treatment of patients admitted to an internal medicine service using the methodology of evidence-based medicine. From November 2012 to February 2013, patients who were hospitalised in the internal medicine service of Regional Hospital of Lugano (Switzerland) and generated questions on medical care were randomly assigned to two groups: an 'intervention group' (supported by the literature research) and a 'control group' (not supported by the literature research). The information obtained from the literature was submitted by email to all members of the medical team within 12 h after asking the question. Two hundred and one participants, from 866 patients hospitalised in the analysed period, divided into intervention (n=101) and control (n=100) groups, generated questions. In the intervention group, bibliographical research was possible for 98 participants. The medical team accepted the results and implemented the research for 90.8% of these participants (89/98). Statistical analyses were carried out on the intention-to-treat and on the per-protocol populations. Bibliographical research had a significant protective effect on transfer to an intensive care unit (relative risk (RR)=0.30; 95% CI 0.10 to 0.90; χ²=5.3, p=0.02) and hospital readmissions were also influenced by bibliographical research (RR=0.42; 95% CI 0.17 to 1.0; χ²=3.36, p=0.05) in the intention-to-treat population. Our results point out the importance of bibliographical support on the quality of medical care. In particular, they show its possible impact on clinical outcome. EOC Registry (registration number: 14-055).

  10. A randomised controlled trial of the efficacy and safety of allopurinol dose escalation to achieve target serum urate in people with gout.

    Science.gov (United States)

    Stamp, Lisa K; Chapman, Peter T; Barclay, Murray L; Horne, Anne; Frampton, Christopher; Tan, Paul; Drake, Jill; Dalbeth, Nicola

    2017-09-01

    To determine the efficacy and safety of allopurinol dose escalation using a treat-to-target serum urate (SU) approach. A randomised, controlled, parallel-group, comparative clinical trial was undertaken. People with gout receiving at least creatinine clearance (CrCL)-based allopurinol dose for ≥1 month and SU ≥6 mg/dL were recruited. Participants were randomised to continue current dose (control) or allopurinol dose escalation for 12 months. In the dose escalation group, allopurinol was increased monthly until SU was gout. Allopurinol dose escalation is well tolerated. ANZCTR12611000845932; Results. 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/.

  11. Discrepancies in sample size calculations and data analyses reported in randomised trials: comparison of publications with protocols

    DEFF Research Database (Denmark)

    Chan, A.W.; Hrobjartsson, A.; Jorgensen, K.J.

    2008-01-01

    OBJECTIVE: To evaluate how often sample size calculations and methods of statistical analysis are pre-specified or changed in randomised trials. DESIGN: Retrospective cohort study. Data source Protocols and journal publications of published randomised parallel group trials initially approved...... in 1994-5 by the scientific-ethics committees for Copenhagen and Frederiksberg, Denmark (n=70). MAIN OUTCOME MEASURE: Proportion of protocols and publications that did not provide key information about sample size calculations and statistical methods; proportion of trials with discrepancies between...... of handling missing data was described in 16 protocols and 49 publications. 39/49 protocols and 42/43 publications reported the statistical test used to analyse primary outcome measures. Unacknowledged discrepancies between protocols and publications were found for sample size calculations (18/34 trials...

  12. High dose melphalan in the treatment of advanced neuroblastoma: results of a randomised trial (ENSG-1) by the European Neuroblastoma Study Group

    NARCIS (Netherlands)

    Pritchard, Jon; Cotterill, Simon J.; Germond, Shirley M.; Imeson, John; de Kraker, Jan; Jones, David R.

    2005-01-01

    High dose myeloablative chemotherapy ("megatherapy"), with haematopoietic stem cell support, is now widely used to consolidate response to induction chemotherapy in patients with advanced neuroblastoma. In this study (European Neuroblastoma Study Group, ENSG1), the value of melphalan myeloablative

  13. Confirmatory double-blind, parallel-group, placebo-controlled study of efficacy and safety of edaravone (MCI-186) in amyotrophic lateral sclerosis patients.

    Science.gov (United States)

    Abe, Koji; Itoyama, Yasuto; Sobue, Gen; Tsuji, Shoji; Aoki, Masashi; Doyu, Manabu; Hamada, Chikuma; Kondo, Kazuoki; Yoneoka, Takatomo; Akimoto, Makoto; Yoshino, Hiide

    2014-12-01

    Our objective was to confirm the efficacy and safety of edaravone in amyotrophic lateral sclerosis (ALS) patients. We conducted a 36-week confirmatory study, consisting of 12-week pre-observation period followed by 24-week treatment period. Patients received placebo or edaravone i.v. infusion over 60 min for the first 14 days in cycle 1, and for 10 of the first 14 days during cycles 2 to 6. The efficacy primary endpoint was changed in the revised ALS functional rating scale (ALSFRS-R) scores during the 24-week treatment. Patients were treated with placebo (n = 104) and edaravone (n = 102). Changes in ALSFRS-R during the 24-week treatment were -6.35 ± 0.84 in the placebo group (n = 99) and -5.70 ± 0.85 in the edaravone group (n = 100), with a difference of 0.65 ± 0.78 (p = 0.411). Adverse events amounted to 88.5% (92/104) in the placebo group and 89.2% (91/102) in the edaravone group. In conclusion, the reduction of ALSFRS-R was smaller in the edaravone group than in the placebo group, but efficacy of edaravone for treatment of ALS was not demonstrated. Levels and frequencies of reported adverse events were similar in the two groups.

  14. Beyond the treatment effect: Evaluating the effects of patient preferences in randomised trials.

    Science.gov (United States)

    Walter, S D; Turner, R; Macaskill, P; McCaffery, K J; Irwig, L

    2017-02-01

    The treatments under comparison in a randomised trial should ideally have equal value and acceptability - a position of equipoise - to study participants. However, it is unlikely that true equipoise exists in practice, because at least some participants may have preferences for one treatment or the other, for a variety of reasons. These preferences may be related to study outcomes, and hence affect the estimation of the treatment effect. Furthermore, the effects of preferences can sometimes be substantial, and may even be larger than the direct effect of treatment. Preference effects are of interest in their own right, but they cannot be assessed in the standard parallel group design for a randomised trial. In this paper, we describe a model to represent the impact of preferences on trial outcomes, in addition to the usual treatment effect. In particular, we describe how outcomes might differ between participants who would choose one treatment or the other, if they were free to do so. Additionally, we investigate the difference in outcomes depending on whether or not a participant receives his or her preferred treatment, which we characterise through a so-called preference effect. We then discuss several study designs that have been proposed to measure and exploit data on preferences, and which constitute alternatives to the conventional parallel group design. Based on the model framework, we determine which of the various preference effects can or cannot be estimated with each design. We also illustrate these ideas with some examples of preference designs from the literature.

  15. Autogenous bone versus deproteinised bovine bone matrix in 1-stage lateral sinus floor elevation in the severely atrophied maxilla: a randomised controlled trial.

    Science.gov (United States)

    Merli, Mauro; Moscatelli, Marco; Mariotti, Giorgia; Rotundo, Roberto; Nieri, Michele

    2013-01-01

    To compare 100% deproteinised bovine bone matrix (DBBM) grafts (test group) with 100% autogenous bone (AB) grafts (control group) for lateral maxillary sinus floor elevation in a parallel group, superiority, randomised controlled trial. Patients with 1 to 3 mm of residual bone height below the maxillary sinus were randomised for sinus floor elevation with DBBM and AB grafts and simultaneous implant placement. Randomisation was computer generated with allocation concealment by sealed envelopes and the radiographic examiner was blinded to group assignment. The abutment connection was performed 8 months after surgery and insertion of the provisional prostheses was performed 9 months after surgery. Outcome variables were implant failures, prosthetic failures, complications, chair time, postoperative pain and radiographic bone level 6 months after loading. Forty patients were randomised: 20 (32 implants) to the DBBM group and 20 (27 implants) to the AB group. One patient from the AB group dropped out. Two implant failures occurred in the DBBM group and no implant failure occurred in the AB group (P = 0.4872). All of the planned prostheses could be delivered. One complication occurred in the DBBM group and 2 in the AB group (P = 0.6050). Chair time was shorter for the DBBM group, with a difference of 27.3 minutes (P = 0.0428). Pain difference measured with a visual analogue scale for 6 days post-surgery was 0.2 in favour of the DBBM group (P = 0.6838). The difference in vertical bone height was 0.0 mm (95% CI -1.1, 1.1; P = 0.9703) and the difference in marginal bone level was 0.3 in favour of AB (95% CI -0.3, 0.9; P = 0.3220). No differences apart from chair time were observed when comparing DBBM and AB grafts with simultaneous implant placement in sinus elevation.

  16. Metformin treatment in type 2 diabetes in pregnancy: an active controlled, parallel-group, randomized, open label study in patients with type 2 diabetes in pregnancy.

    Science.gov (United States)

    Ainuddin, Jahan Ara; Karim, Nasim; Zaheer, Sidra; Ali, Syed Sanwer; Hasan, Anjum Ara

    2015-01-01

    To assess the effect of metformin and to compare it with insulin treatment in patients with type 2 diabetes in pregnancy in terms of perinatal outcome, maternal complications, additional insulin requirement, and treatment acceptability. In this randomized, open label study, 206 patients with type 2 diabetes in pregnancy who met the eligibility criteria were selected from the antenatal clinics. Insulin was added to metformin treatment when required, to maintain the target glycemic control. The patients were followed up till delivery. Maternal, and perinatal outcomes and pharmacotherapeutic characteristics were recorded on a proforma. Maternal characteristics were comparable in metformin and insulin treated group. 84.9% patients in metformin group required add-on insulin therapy at mean gestational age of 26.58 ± 3.85 weeks. Less maternal weight gain (P pregnancy induced hypertension (P = 0.029) were observed in metformin treated group. Small for date babies were more in metformin group (P 24 hours in metformin group (P metformin group. Metformin alone or with add-on insulin is an effective and cheap treatment option for patients with type 2 diabetes in pregnancy. This trial is registered with clinical trial registration number: Clinical trials.gov NCT01855763.

  17. The EC randomised controlled trial of prophylactic ethamsylate for very preterm neonates: early mortality and morbidity. The EC Ethamsylate Trial Group.

    Science.gov (United States)

    1994-05-01

    Immature infants are at increased risk of death and disability, often related to haemorrhagic and ischaemic brain damage. Two controlled trials have suggested that a policy of prophylactic ethamsylate may reduce this damage. The aim of the trial reported here was to assess the effects of such a policy in respect of death, disability, and the use of health service resources up to 2 years of age. Short term findings are reported here. Three hundred and thirty four immature (ethamsylate group received the drug, compared with one of the 169 infants in the control group. By about 3 months of age the trial groups were similar in terms of death (20% in the two groups), any diagnosis of periventricular or intraventricular haemorrhage (35% in the ethamsylate v 37% in the control group), or major cerebral abnormality assessed by ultrasound (13% v 12%). The trial provides little evidence to support the use of ethamsylate for routine prophylaxis. The confidence intervals are wide, however, and so these results alone cannot rule out a clinically useful benefit or a harmful effect. A follow up study of the surviving children at the age of 2 years is in progress.

  18. CArbon dioxide surgical field flooding and aortic NO-touch off-pump coronary artery bypass grafting to reduce Neurological injuries after surgical coronary revascularisation (CANON): protocol for a randomised, controlled, investigator and patient blinded single-centre superiority trial with three parallel arms

    Science.gov (United States)

    Szwed, Krzysztof; Pawliszak, Wojciech; Serafin, Zbigniew; Kowalewski, Mariusz; Tomczyk, Remigiusz; Perlinski, Damian; Szwed, Magdalena; Tomaszewska, Marta; Anisimowicz, Lech; Borkowska, Alina

    2017-01-01

    Introduction Neurological injuries remain a major concern following coronary artery bypass grafting (CABG) that offsets survival benefit of CABG over percutaneous coronary interventions. Among numerous efforts to combat this issue is the development of off-pump CABG (OPCABG) that obviates the need for extracorporeal circulation and is associated with improved neurological outcomes. The objective of this study is to examine whether the neuroprotective effect of OPCABG can be further pronounced by the use of two state-of-the-art operating techniques. Methods and analysis In this randomised, controlled, investigator and patient blinded single-centre superiority trial with three parallel arms, a total of 360 patients will be recruited. They will be allocated in a 1:1:1 ratio to two treatment arms and one control arm. Treatment arms undergoing either aortic no-touch OPCABG or OPCABG with partial clamp applying carbon dioxide surgical field flooding will be compared against control arm undergoing OPCABG with partial clamp. The primary endpoint will be the appearance of new lesions on control brain MRI 3 days after surgery. Secondary endpoints will include the prevalence of new focal neurological deficits in the first 7 days after surgery, the occurrence of postoperative cognitive dysfunction at either 1 week or 3 months after surgery and the incidence of delirium in the first 7 days after surgery. Data will be analysed on intention-to-treat principles and a per protocol basis. Ethics and dissemination Ethical approval has been granted for this study. Results will be disseminated through peer-reviewed media. Trial registration number NCT03074604; Pre-results. Date and version identifier 10-Mar-2017 Original PMID:28698347

  19. CArbon dioxide surgical field flooding and aortic NO-touch off-pump coronary artery bypass grafting to reduce Neurological injuries after surgical coronary revascularisation (CANON): protocol for a randomised, controlled, investigator and patient blinded single-centre superiority trial with three parallel arms.

    Science.gov (United States)

    Krzysztof, Szwed; Wojciech, Pawliszak; Zbigniew, Serafin; Mariusz, Kowalewski; Remigiusz, Tomczyk; Damian, Perlinski; Magdalena, Szwed; Marta, Tomaszewska; Lech, Anisimowicz; Alina, Borkowska

    2017-07-10

    Neurological injuries remain a major concern following coronary artery bypass grafting (CABG) that offsets survival benefit of CABG over percutaneous coronary interventions. Among numerous efforts to combat this issue is the development of off-pump CABG (OPCABG) that obviates the need for extracorporeal circulation and is associated with improved neurological outcomes. The objective of this study is to examine whether the neuroprotective effect of OPCABG can be further pronounced by the use of two state-of-the-art operating techniques. In this randomised, controlled, investigator and patient blinded single-centre superiority trial with three parallel arms, a total of 360 patients will be recruited. They will be allocated in a 1:1:1 ratio to two treatment arms and one control arm. Treatment arms undergoing either aortic no-touch OPCABG or OPCABG with partial clamp applying carbon dioxide surgical field flooding will be compared against control arm undergoing OPCABG with partial clamp. The primary endpoint will be the appearance of new lesions on control brain MRI 3 days after surgery. Secondary endpoints will include the prevalence of new focal neurological deficits in the first 7 days after surgery, the occurrence of postoperative cognitive dysfunction at either 1 week or 3 months after surgery and the incidence of delirium in the first 7 days after surgery. Data will be analysed on intention-to-treat principles and a per protocol basis. Ethical approval has been granted for this study. Results will be disseminated through peer-reviewed media. NCT03074604; Pre-results. 10-Mar-2017 Original. © 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.

  20. Resource-enhancing group intervention against depression at workplace: who benefits? A randomised controlled study with a 7-month follow-up.

    Science.gov (United States)

    Ahola, Kirsi; Vuori, Jukka; Toppinen-Tanner, Salla; Mutanen, Pertti; Honkonen, Teija

    2012-12-01

    The aim of the present study was to investigate whether participation in a structured resource-enhancing group intervention at work would act as primary prevention against depression. The authors analysed whether the intervention resulted in universal, selected or indicated prevention. A total of 566 persons participated in a prospective, within-organisation, randomly assigned field experimental study, which consisted of 34 workshops in 17 organisations. The participants filled in a questionnaire, were randomly assigned to either intervention (n=296) or comparison (n=324) groups and returned another questionnaire 7 months later. The intervention, lasting four half-day sessions, was delivered by trainers from occupational health services and human resources. The aim of the structured programme was to enhance participants' career management preparedness by strengthening self-efficacy and inoculation against setbacks. The comparison group received a literature package. The authors measured depressive symptoms using the short version of the Beck Depression Inventory. A high number of depressive symptoms (over 9 points) were used as a proxy for depression. At follow-up, the odds of depression were lower in the intervention group (OR=0.40, 95% CI 0.19 to 0.85) than in the comparison group when adjusted for baseline depressive symptoms, job strain and socio-demographics. In addition, the odds of depression among those with job strain (OR=0.15, 95% CI 0.03-0.81) at baseline were lower after the intervention. The intervention had no statistically significant effect on those with depressive symptoms (over 4 points) at baseline. The resource-enhancing group intervention appeared to be successful as universal and selective prevention of potential depression.

  1. Diabetes mellitus and abnormal glucose tolerance development after gestational diabetes: A three-year, prospective, randomized, clinical-based, Mediterranean lifestyle interventional study with parallel groups.

    Science.gov (United States)

    Pérez-Ferre, Natalia; Del Valle, Laura; Torrejón, Maria José; Barca, Idoya; Calvo, María Isabel; Matía, Pilar; Rubio, Miguel A; Calle-Pascual, Alfonso L

    2015-08-01

    Women with prior gestational diabetes mellitus (GDM) have a high risk of developing type 2 diabetes mellitus (DM2) in later life. The study aim was to evaluate the efficacy of a lifestyle intervention for the prevention of glucose disorders (impaired fasting glucose, impaired glucose tolerance or DM2) in women with prior GDM. A total of 260 women with prior GDM who presented with normal fasting plasma glucose at six to twelve weeks postpartum were randomized into two groups: a Mediterranean lifestyle intervention group (n = 130) who underwent an educational program on nutrition and a monitored physical activity program and a control group (n = 130) with a conventional follow-up. A total of 237 women completed the three-year follow-up (126 in the intervention group and 111 in the control group). Their glucose disorders rates, clinical and metabolic changes and rates of adherence to the Mediterranean lifestyle were analyzed. Less women in the intervention group (42.8%) developed glucose disorders at the end of the three-year follow-up period compared with the control group (56.75%), p Lifestyle intervention was effective for the prevention of glucose disorders in women with prior GDM. Body weight gain and an unhealthy fat intake pattern were found to be the most predictive factors for the development of glucose disorders. Current Controlled trials: ISRCTN24165302. http://www.controlled-trials.com/isrctn/pf/24165302. Copyright © 2014 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  2. Managing Repetitive Behaviours in Young Children with Autism Spectrum Disorder (ASD): Pilot Randomised Controlled Trial of a New Parent Group Intervention

    Science.gov (United States)

    Grahame, Victoria; Brett, Denise; Dixon, Linda; McConachie, Helen; Lowry, Jessica; Rodgers, Jacqui; Steen, Nick; Le Couteur, Ann

    2015-01-01

    Early intervention for autism spectrum disorder (ASD) tends to focus on enhancing social-communication skills. We report the acceptability, feasibility and impact on child functioning of a new 8 weeks parent-group intervention to manage restricted and repetitive behaviours (RRB) in young children with ASD aged 3-7 years. Forty-five families took…

  3. Once a week is not enough: Effects of a widely implemented group based exercise programme for older adults; a randomised controlled trial

    NARCIS (Netherlands)

    Stiggelbout, M.; Popkema, D.Y.; Hopman-Rock, M.; Greef, M. de; Mechelen, W. van

    2004-01-01

    Objectives: To determine the effects of gymnastics on the health related quality of life (HRQoL) and functional status of independently living people, aged 65 to 80 years. Gymnastics formed part of the More Exercise for Seniors (MBvO in Dutch) programme, a group based exercise programme for older

  4. Once a week is not enough : effects of a widely implemented group based exercise programme for older adults; a randomised controlled trial

    NARCIS (Netherlands)

    Stiggelbout, M.; Popkema, D.Y.; Hopman-Rock, M.; de Greef, M.; van Mechelen, W.

    2004-01-01

    OBJECTIVES: To determine the effects of gymnastics on the health related quality of life (HRQoL) and functional status of independently living people, aged 65 to 80 years. Gymnastics formed part of the More Exercise for Seniors (MBvO in Dutch) programme, a group based exercise programme for older

  5. Reaching the poor with health interventions: Programme-incidence analysis of seven randomised trials of women's groups to reduce newborn mortality in Asia and Africa

    NARCIS (Netherlands)

    A.J. Houweling (Tanja); J. Morrison (Jonathan); G. Alcock (Glyn); K. Azad (Kishwar); S. Das (Sushmita); M. Hossen (Munir); A. Kuddus (Abdul); S. Lewycka (Sonia); C.W.N. Looman (Caspar); B.B. Magar (Bharat Budhathoki); D.S. Manandhar (Dharma S.); M. Akter (Mahfuza); A.L. Nkhata Dube (Albert Lazarous); S. Rath (Santosh); N. Saville (Naomi); A. Sen (Aman); P. Tripathy (Prasanta); A. Costello (Anthony); J. Bamjan (Jyoti); B.H. Aumon (Bedowra Haq); M. Madina (Mantu); F. Malamba (Florida); R.M. Basiya (Riddhima Mehta); S. Pathak (Shrijana); T. Phiri (Tambosi); A. Rosato (Antonio); K. Sah (Kabita); N.S. More (Neena Shah); S. Surve (Sweta); R. Tiwari (Rinku); C.O.F. Zamawe (Collins O.F.); D. Osrin (David)

    2015-01-01

    textabstractBackground Efforts to end preventable newborn deaths will fail if the poor are not reached with effective interventions. To understand what works to reach vulnerable groups, we describe and explain the uptake of a highly effective community-based newborn health intervention across social

  6. Daily electronic self-monitoring in bipolar disorder using smartphones - the MONARCA I trial: a randomized, placebo-controlled, single-blind, parallel group trial.

    Science.gov (United States)

    Faurholt-Jepsen, M; Frost, M; Ritz, C; Christensen, E M; Jacoby, A S; Mikkelsen, R L; Knorr, U; Bardram, J E; Vinberg, M; Kessing, L V

    2015-10-01

    The number of studies on electronic self-monitoring in affective disorder and other psychiatric disorders is increasing and indicates high patient acceptance and adherence. Nevertheless, the effect of electronic self-monitoring in patients with bipolar disorder has never been investigated in a randomized controlled trial (RCT). The objective of this trial was to investigate in a RCT whether the use of daily electronic self-monitoring using smartphones reduces depressive and manic symptoms in patients with bipolar disorder. A total of 78 patients with bipolar disorder according to ICD-10 criteria, aged 18-60 years, and with 17-item Hamilton Depression Rating Scale (HAMD-17) and Young Mania Rating Scale (YMRS) scores ≤17 were randomized to the use of a smartphone for daily self-monitoring including a clinical feedback loop (the intervention group) or to the use of a smartphone for normal communicative purposes (the control group) for 6 months. The primary outcomes were differences in depressive and manic symptoms measured using HAMD-17 and YMRS, respectively, between the intervention and control groups. Intention-to-treat analyses using linear mixed models showed no significant effects of daily self-monitoring using smartphones on depressive as well as manic symptoms. There was a tendency towards more sustained depressive symptoms in the intervention group (B = 2.02, 95% confidence interval -0.13 to 4.17, p = 0.066). Sub-group analysis among patients without mixed symptoms and patients with presence of depressive and manic symptoms showed significantly more depressive symptoms and fewer manic symptoms during the trial period in the intervention group. These results highlight that electronic self-monitoring, although intuitive and appealing, needs critical consideration and further clarification before it is implemented as a clinical tool.

  7. Five years' experience of transverse groin incision for femoral artery access in arterial reconstructive surgery: parallel observational longitudinal group comparison study.

    LENUS (Irish Health Repository)

    Beirne, Christopher

    2008-07-01

    Vertical groin incisions (VGIs) have been used to access femoral vessels, but reports allude to wound complications. Our aim was to compare VGI with transverse groin incision (TGI) for femoral artery exposure. Over a 5-year interval, 196 patients with 284 femoral artery exposures for supra- and infrainguinal procedures were studied. Primary endpoints were surgical skin site wound infection, seroma, haematoma formation, and major lower limb amputation. Secondary endpoints were graft patency, wound paresthesias, and length of hospital stay. There were 160 TGIs and 124 VGIs. The demographics and risk factor profile were not statistically different between groups. Seroma developed in 4.4% of TGIs and 13.7% of VGIs (p= .005). The complicated skin and soft tissue infection rate was five times greater with VGI (p= .001). The VGI group had a significantly higher rate of major amputation (p= .0005). Significantly higher graft failure rates were observed in the VGI group (p= .011). No paresthesia was reported in any TGI wound. The mean hospital stay was also significantly shorter in the TGI group (p= .006). The study data support and expound on the theory that an alternative incision to VGI offers lower short- and long-term morbidity. Our findings sustain the selection of the TGI in femoral artery surgery for both supra- and infrainguinal procedures without compromise of vessel exposure.

  8. Metformin Treatment in Type 2 Diabetes in Pregnancy: An Active Controlled, Parallel-Group, Randomized, Open Label Study in Patients with Type 2 Diabetes in Pregnancy

    Directory of Open Access Journals (Sweden)

    Jahan Ara Ainuddin

    2015-01-01

    Full Text Available Aims. To assess the effect of metformin and to compare it with insulin treatment in patients with type 2 diabetes in pregnancy in terms of perinatal outcome, maternal complications, additional insulin requirement, and treatment acceptability. Methods. In this randomized, open label study, 206 patients with type 2 diabetes in pregnancy who met the eligibility criteria were selected from the antenatal clinics. Insulin was added to metformin treatment when required, to maintain the target glycemic control. The patients were followed up till delivery. Maternal, and perinatal outcomes and pharmacotherapeutic characteristics were recorded on a proforma. Results. Maternal characteristics were comparable in metformin and insulin treated group. 84.9% patients in metformin group required add-on insulin therapy at mean gestational age of 26.58 ± 3.85 weeks. Less maternal weight gain (P24 hours in metformin group (P<0.01. Significant reduction in cost of treatment was found in metformin group. Conclusion. Metformin alone or with add-on insulin is an effective and cheap treatment option for patients with type 2 diabetes in pregnancy. This trial is registered with clinical trial registration number: Clinical trials.gov NCT01855763.

  9. Randomised, double-blind, placebo-controlled studies on flurbiprofen 8.75 mg lozenges in patients with/without group A or C streptococcal throat infection, with an assessment of clinicians' prediction of 'strep throat'.

    Science.gov (United States)

    Shephard, A; Smith, G; Aspley, S; Schachtel, B P

    2015-01-01

    Diagnosing group A streptococcus (Strep A) throat infection by clinical examination is difficult, and misdiagnosis may lead to inappropriate antibiotic use. Most patients with sore throat seek symptom relief rather than antibiotics, therefore, therapies that relieve symptoms should be recommended to patients. We report two clinical trials on the efficacy and safety of flurbiprofen 8.75 mg lozenge in patients with and without streptococcal sore throat. The studies enrolled adults with moderate-to-severe throat symptoms (sore throat pain, difficulty swallowing and swollen throat) and a diagnosis of pharyngitis. The practitioner assessed the likelihood of Strep A infection based on historical and clinical findings. Patients were randomised to flurbiprofen 8.75 mg or placebo lozenges under double-blind conditions and reported the three throat symptoms at baseline and at regular intervals over 24 h. A total of 402 patients received study medication (n = 203 flurbiprofen, n = 199 placebo). Throat culture identified Strep A in 10.0% of patients and group C streptococcus (Strep C) in a further 14.0%. The practitioners' assessments correctly diagnosed Strep A in 11/40 cases (sensitivity 27.5%, and specificity 79.7%). A single flurbiprofen lozenge provided significantly greater relief than placebo for all three throat symptoms, lasting 3-4 h for patients with and without Strep A/C. Multiple doses of flurbiprofen lozenges over 24 h also led to symptom relief, although not statistically significant in the Strep A/C group. There were no serious adverse events. The results highlight the challenge of identifying Strep A based on clinical features. With the growing problem of antibiotic resistance, non-antibiotic treatments should be considered. As demonstrated here, flurbiprofen 8.75 mg lozenges are an effective therapeutic option, providing immediate and long-lasting symptom relief in patients with and without Strep A/C infection. © 2014 John Wiley & Sons Ltd.

  10. Comparison of the temperature and humidity in the anesthetic breathing circuit among different anesthetic workstations: Updated guidelines for reporting parallel group randomized trials.

    Science.gov (United States)

    Choi, Yoon Ji; Min, Sam Hong; Park, Jeong Jun; Cho, Jang Eun; Yoon, Seung Zhoo; Yoon, Suk Min

    2017-06-01

    For patients undergoing general anesthesia, adequate warming and humidification of the inspired gases is very important. The aim of this study was to evaluate the differences in the heat and moisture content of the inspired gases with low-flow anesthesia using 4 different anesthesia machines. The patients were divided into 11 groups according to the anesthesia machine used (Ohmeda, Excel; Avance; Dräger, Cato; and Primus) and the fresh gas flow (FGF) rate (0.5, 1, and 4 L/min). The temperature and absolute humidity of the inspired gas in the inspiratory limbs were measured at 5, 10, 15, 30, 45, 60, 75, 90, 105, and 120 minutes in 9 patients scheduled for total thyroidectomy or cervical spine operation in each group. The anesthesia machines of Excel, Avance, Cato, and Primus did not show statistically significant changes in the inspired gas temperatures over time within each group with various FGFs. They, however, showed statistically significant changes in the absolute humidity of the inspired gas over time within each group with low FGF anesthesia (P humidity of the inspired gas over time within each group with an FGF of 4 L/min (P humidities of the inspired gas for all anesthesia machines were lower than the recommended values. There were statistical differences in the provision of humidity among different anesthesia workstations. The Cato and Primus workstations were superior to Excel and Avance. However, even these were unsatisfactory in humans. Therefore, additional devices that provide inspired gases with adequate heat and humidity are needed for those undergoing general anesthetic procedures.

  11. Specialist group therapy for firesetting behaviour: evidence of a treatment effect from a non-randomised pilot trial with male prisoners

    OpenAIRE

    Gannon, T.; Alleyne, E.; Butler, H.; Danby, H.; Kapoor, A.; Lovell, T.; Mozova, K.; Spruin, E.; Tostevin, T.; Tyler, N.; O'Ciardha, C.

    2015-01-01

    Despite huge societal costs associated with firesetting, no standardized therapy has been developed to address this hugely damaging behavior. This study reports the evaluation of the first standardized CBT group designed specifically to target deliberate firesetting in male prisoners (the Firesetting Intervention Programme for Prisoners; FIPP). Fifty-four male prisoners who had set a deliberate fire were referred for FIPP treatment by their prison establishment and psychologically assessed at...

  12. More parallel please

    DEFF Research Database (Denmark)

    Gregersen, Frans; Josephson, Olle; Kristoffersen, Gjert

    of departure that English may be used in parallel with the various local, in this case Nordic, languages. As such, the book integrates the challenge of internationalization faced by any university with the wish to improve quality in research, education and administration based on the local language......Abstract [en] More parallel, please is the result of the work of an Inter-Nordic group of experts on language policy financed by the Nordic Council of Ministers 2014-17. The book presents all that is needed to plan, practice and revise a university language policy which takes as its point......(s). There are three layers in the text: First, you may read the extremely brief version of the in total 11 recommendations for best practice. Second, you may acquaint yourself with the extended version of the recommendations and finally, you may study the reasoning behind each of them. At the end of the text, we give...

  13. Applying the intention-to-treat principle in practice: Guidance on handling randomisation errors.

    Science.gov (United States)

    Yelland, Lisa N; Sullivan, Thomas R; Voysey, Merryn; Lee, Katherine J; Cook, Jonathan A; Forbes, Andrew B

    2015-08-01

    The intention-to-treat principle states that all randomised participants should be analysed in their randomised group. The implications of this principle are widely discussed in relation to the analysis, but have received limited attention in the context of handling errors that occur during the randomisation process. The aims of this article are to (1) demonstrate the potential pitfalls of attempting to correct randomisation errors and (2) provide guidance on handling common randomisation errors when they are discovered that maintains the goals of the intention-to-treat principle. The potential pitfalls of attempting to correct randomisation errors are demonstrated and guidance on handling common errors is provided, using examples from our own experiences. We illustrate the problems that can occur when attempts are made to correct randomisation errors and argue that documenting, rather than correcting these errors, is most consistent with the intention-to-treat principle. When a participant is randomised using incorrect baseline information, we recommend accepting the randomisation but recording the correct baseline data. If ineligible participants are inadvertently randomised, we advocate keeping them in the trial and collecting all relevant data but seeking clinical input to determine their appropriate course of management, unless they can be excluded in an objective and unbiased manner. When multiple randomisations are performed in error for the same participant, we suggest retaining the initial randomisation and either disregarding the second randomisation if only one set of data will be obtained for the participant, or retaining the second randomisation otherwise. When participants are issued the incorrect treatment at the time of randomisation, we propose documenting the treatment received and seeking clinical input regarding the ongoing treatment of the participant. Randomisation errors are almost inevitable and should be reported in trial publications. The

  14. Desensitization to a whole egg by rush oral immunotherapy improves the quality of life of guardians: A multicenter, randomized, parallel-group, delayed-start design study.

    Science.gov (United States)

    Itoh-Nagato, Naoka; Inoue, Yuzaburo; Nagao, Mizuho; Fujisawa, Takao; Shimojo, Naoki; Iwata, Tsutomu

    2018-04-01

    Patients with food allergies and their families have a significantly reduced health-related quality of life (QOL). We performed a multicenter, randomized, parallel-group, delayed-start design study to clarify the efficacy and safety of rush oral immunotherapy (rOIT) and its impact on the participants' daily life and their guardians (UMIN000003943). Forty-five participants were randomly divided into an early-start group and a late-start group. The early-start group received rOIT for 3 months, while the late-start group continued the egg elimination diet (control). In the next stage, both groups received OIT until all participants had finished 12 months of maintenance OIT. The ratio of the participants in whom an increase of the TD was achieved in the first stage was significantly higher in the early-start group (87.0%), than in the late-start group (22.7%). The QOL of the guardians in the early-start group significantly improved after the first stage (65.2%), in comparison to the late-start group (31.8%). During 12 months of rOIT, the serum ovomucoid-specific IgE levels, the percentage of CD203c + basophils upon stimulation with egg white, and the wheal size to egg white were decreased, while the serum ovomucoid-specific IgG4 levels were increased. However, approximately 80% of the participants in the early-start group showed an allergic reaction during the first stage of the study, whereas none of the patients in the late-start group experienced an allergic reaction. rOIT induced desensitization to egg and thus improved the QOL of guardians; however, the participants experienced frequent allergic reactions due to the treatment. Copyright © 2017 Japanese Society of Allergology. Production and hosting by Elsevier B.V. All rights reserved.

  15. A Multicenter, Randomized, Open-Labeled, Parallel Group Trial of Sildenafil in Alcohol-Associated Erectile Dysfunction: The Impact on Psychosocial Outcomes

    Directory of Open Access Journals (Sweden)

    Alexander Grinshpoon

    2009-09-01

    Full Text Available To examine the effect of sildenafil on erectile dysfunction (ED and psychosocial outcomes in alcohol-dependent (AD men, 108 men with these diagnoses were randomly assigned to either take sildenafil (50 mg as add-on to standard treatment for AD, or the same treatment without sildenafil, for 12 weeks. Only 50 patients in sildenafil group and 51 in control group twice completed the International Index of Erectile Function (IIEF and a battery of self-report questionnaires. IIEF scores and psychosocial functioning, self-esteem and support from friends improved only for sildenafil-treated patients (P < 0.001. The high effect sizes suggest that the observed benefits are unlikely to be a placebo effect, although their unspecific nature could not be ruled out. In men with ED associated with AD, sildenafil improves both ED and psychosocial outcomes. Further placebo-controlled clinical trial is warranted.

  16. Efficacy and safety of valproic acid versus haloperidol in patients with acute agitation: results of a randomized, double-blind, parallel-group trial.

    Science.gov (United States)

    Asadollahi, Shadi; Heidari, Kamran; Hatamabadi, Hamidreza; Vafaee, Reza; Yunesian, Somayeh; Azadbakht, Alireza; Mirmohseni, Ladan

    2015-05-01

    The objective of this study was to compare the efficacy of valproate versus haloperidol in decreasing the agitation level in affected patients in the emergency department. We assigned 80 acutely agitated patients to receive either intravenous sodium valproate (20 mg/kg) or intramuscular haloperidol (5 mg/1 ml). Agitation was measured at baseline and 30 min after the first injection using the Agitation-Calmness Evaluation Scale (ACES), the Positive and Negative Syndrome Scale-Excited Component subscale, and the Agitated Behavior Scale. For 80 patients treated with sodium valproate, the mean ± SD dosage was 1541.5 ± 286 mg (range 940-2400). The mean postintervention ACES scores from baseline to 30 min after drug injection were 4.73 (SD = 1.93) for the valproate group and 5.45 (SD = 2.09) for the haloperidol group (P = 0.028). No significant differences were observed in terms of the mean changes 30 min after the intervention for two additional agitation scales. A larger proportion of patients in the haloperidol group experienced intense sedation (36.2%, P haloperidol in reducing agitation, with a better safety profile.

  17. Tramadol/paracetamol combination tablet for postoperative pain following ambulatory hand surgery: a double-blind, double-dummy, randomized, parallel-group trial

    Science.gov (United States)

    Rawal, Narinder; Macquaire, Valery; Catalá, Elena; Berti, Marco; Costa, Rui; Wietlisbach, Markus

    2011-01-01

    This randomized, double-blind, double-dummy, multicenter trial compared efficacy and safety of tramadol HCL 37.5 mg/paracetamol 325 mg combination tablet with tramadol HCL 50 mg capsule in the treatment of postoperative pain following ambulatory hand surgery with iv regional anesthesia. Patients received trial medication at admission, immediately after surgery, and every 6 hours after discharge until midnight of the first postoperative day. Analgesic efficacy was assessed by patients (n = 128 in each group, full analysis set) and recorded in a diary on the evening of surgery day and of the first postoperative day. They also documented the occurrence of adverse events. By the end of the first postoperative day, the proportion of treatment responders based on treatment satisfaction (primary efficacy variable) was comparable between the groups (78.1% combination, 71.9% tramadol; P = 0.24) and mean pain intensity (rated on a numerical scale from 0 = no pain to 10 = worst imaginable pain) had been reduced to 1.7 ± 2.0 for both groups. Under both treatments, twice as many patients experienced no pain (score = 0) on the first postoperative day compared to the day of surgery (35.9% vs 16.4% for tramadol/paracetamol and 36.7% vs 18% for tramadol treatment). Rescue medication leading to withdrawal (diclofenac 50 mg) was required by 17.2% patients with tramadol/paracetamol and 13.3% with tramadol. Adverse events (mainly nausea, dizziness, somnolence, vomiting, and increased sweating) occurred less frequently in patients under combination treatment (P = 0.004). Tramadol/paracetamol combination tablets provided comparable analgesic efficacy with a better safety profile to tramadol capsules in patients experiencing postoperative pain following ambulatory hand surgery. PMID:21559356

  18. Target Temperature Management after out-of-hospital cardiac arrest--a randomized, parallel-group, assessor-blinded clinical trial--rationale and design

    DEFF Research Database (Denmark)

    Nielsen, Niklas; Wetterslev, Jørn; al-Subaie, Nawaf

    2012-01-01

    Experimental animal studies and previous randomized trials suggest an improvement in mortality and neurologic function with induced hypothermia after cardiac arrest. International guidelines advocate the use of a target temperature management of 32°C to 34°C for 12 to 24 hours after resuscitation...... from out-of-hospital cardiac arrest. A systematic review indicates that the evidence for recommending this intervention is inconclusive, and the GRADE level of evidence is low. Previous trials were small, with high risk of bias, evaluated select populations, and did not treat hyperthermia...... in the control groups. The optimal target temperature management strategy is not known....

  19. A prospective, randomised, controlled, double-blind phase I-II clinical trial on the safety of A-Part® Gel as adhesion prophylaxis after major abdominal surgery versus non-treated group

    Directory of Open Access Journals (Sweden)

    Weis Christine

    2010-07-01

    Full Text Available Abstract Background Postoperative adhesions occur when fibrous strands of internal scar tissue bind anatomical structures to one another. The most common cause of intra-abdominal adhesions is previous intra-abdominal surgical intervention. Up to 74% of intestinal obstructions are caused by post surgical adhesions. Although a variety of methods and agents have been investigated to prevent post surgical adhesions, the problem of peritoneal adhesions remains largely unsolved. Materials serving as an adhesion barrier are much needed. Methods/Design This is a prospective, randomised, controlled, patient blinded and observer blinded, single centre phase I-II trial, which evaluates the safety of A-Part® Gel as an adhesion prophylaxis after major abdominal wall surgery, in comparison to an untreated control group. 60 patients undergoing an elective median laparotomy without prior abdominal surgery are randomly allocated into two groups of a 1:1- ratio. Safety parameter and primary endpoint of the study is the occurrence of wound healing impairment or peritonitis within 28 (+10 days after surgery. The frequency of anastomotic leakage within 28 days after operation, occurrence of adverse and serious adverse events during hospital stay up to 3 months and the rate of adhesions along the scar within 3 months are defined as secondary endpoints. After hospital discharge the investigator will examine the enrolled patients at 28 (+10 days and 3 months (±14 days after surgery. Discussion This trial aims to assess, whether the intra-peritoneal application of A-Part® Gel is safe and efficacious in the prevention of post-surgical adhesions after median laparotomy, in comparison to untreated controls. Trial registration NCT00646412

  20. Parallel-group placebo-controlled trial of testosterone gel in men with major depressive disorder displaying an incomplete response to standard antidepressant treatment.

    Science.gov (United States)

    Pope, Harrison G; Amiaz, Revital; Brennan, Brian P; Orr, Guy; Weiser, Mark; Kelly, John F; Kanayama, Gen; Siegel, Arthur; Hudson, James I; Seidman, Stuart N

    2010-04-01

    Exogenous testosterone therapy has psychotropic effects and has been proposed as an antidepressant augmentation strategy for depressed men. We sought to assess the antidepressant effects of testosterone augmentation of a serotonergic antidepressant in depressed, hypogonadal men. For this study, we recruited 100 medically healthy adult men with major depressive disorder showing partial response or no response to an adequate serotonergic antidepressant trial during the current episode and a screening total testosterone level of 350 ng/dL or lower. We randomized these men to receive testosterone gel or placebo gel in addition to their existing antidepressant regimen. The primary outcome measure was the Hamilton Depression Rating Scale (HDRS) score. Secondary measures included the Montgomery-Asberg Depression Rating Scale, the Clinical Global Impression Scale, and the Quality of Life Scale. Our primary analysis, using a mixed effects linear regression model to compare rate of change of scores between groups on the outcome measures, failed to show a significant difference between groups (mean [95% confidence interval] 6-week change in HDRS for testosterone vs placebo, -0.4 [-2.6 to 1.8]). However, in one exploratory analysis of treatment responders, we found a possible trend in favor of testosterone on the HDRS. Our findings, combined with the conflicting data from earlier smaller studies, suggest that testosterone is not generally effective for depressed men. The possibility remains that testosterone might benefit a particular subgroup of depressed men, but if so, the characteristics of this subgroup would still need to be established.

  1. Tramadol/paracetamol combination tablet for postoperative pain following ambulatory hand surgery: a double-blind, double-dummy, randomized, parallel-group trial

    Directory of Open Access Journals (Sweden)

    Rawal N

    2011-04-01

    Full Text Available Narinder Rawal1, Valery Macquaire2, Elena Catalá3, Marco Berti4, Rui Costa5, Markus Wietlisbach61Department of Anesthesiology and Intensive Care, Örebro University Hospital, Örebro, Sweden; 2Clinique du Parc Leopold, Brussels, Belgium; 3Pain Clinic, Department Anesthesiology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain; 4Department of Anesthesiology and Reanimation, Parma Hospital, Parma, Italy; 5Garcia de Orta Hospital, Almada, Portugal; 6Department of Anesthesiology, Sursee Hospital, Sursee, SwitzerlandAbstract: This randomized, double-blind, double-dummy, multicenter trial compared efficacy and safety of tramadol HCL 37.5 mg/paracetamol 325 mg combination tablet with tramadol HCL 50 mg capsule in the treatment of postoperative pain following ambulatory hand surgery with iv regional anesthesia. Patients received trial medication at admission, immediately after surgery, and every 6 hours after discharge until midnight of the first postoperative day. Analgesic efficacy was assessed by patients (n = 128 in each group, full analysis set and recorded in a diary on the evening of surgery day and of the first postoperative day. They also documented the occurrence of adverse events. By the end of the first postoperative day, the proportion of treatment responders based on treatment satisfaction (primary efficacy variable was comparable between the groups (78.1% combination, 71.9% tramadol; P = 0.24 and mean pain intensity (rated on a numerical scale from 0 = no pain to 10 = worst imaginable pain had been reduced to 1.7 ± 2.0 for both groups. Under both treatments, twice as many patients experienced no pain (score = 0 on the first postoperative day compared to the day of surgery (35.9% vs 16.4% for tramadol/paracetamol and 36.7% vs 18% for tramadol treatment. Rescue medication leading to withdrawal (diclofenac 50 mg was required by 17.2% patients with tramadol/paracetamol and 13.3% with tramadol. Adverse events (mainly nausea, dizziness

  2. Parallelization of quantum molecular dynamics simulation code

    International Nuclear Information System (INIS)

    Kato, Kaori; Kunugi, Tomoaki; Shibahara, Masahiko; Kotake, Susumu

    1998-02-01

    A quantum molecular dynamics simulation code has been developed for the analysis of the thermalization of photon energies in the molecule or materials in Kansai Research Establishment. The simulation code is parallelized for both Scalar massively parallel computer (Intel Paragon XP/S75) and Vector parallel computer (Fujitsu VPP300/12). Scalable speed-up has been obtained with a distribution to processor units by division of particle group in both parallel computers. As a result of distribution to processor units not only by particle group but also by the particles calculation that is constructed with fine calculations, highly parallelization performance is achieved in Intel Paragon XP/S75. (author)

  3. Six years' experience with prostaglandin I2 infusion in elective open repair of abdominal aortic aneurysm: a parallel group observational study in a tertiary referral vascular center.

    LENUS (Irish Health Repository)

    Beirne, Chris

    2008-11-01

    The prostaglandin I(2) (PGI(2)) analogue iloprost, a potent vasodilator and inhibitor of platelet activation, has traditionally been utilized in pulmonary hypertension and off-label use for revascularization of chronic critical lower limb ischemia. This study was designed to assess the effect of 72 hr iloprost infusion on systemic ischemia post-open elective abdominal aortic aneurysm (EAAA) surgery. Between January 2000 and 2007, 104 patients undergoing open EAAA were identified: 36 had juxtarenal, 15 had suprarenal, and 53 had infrarenal aneurysms, with a mean maximal diameter of 6.9 cm. The male-to-female ratio was 2.5:1, with a mean age of 71.9 years. No statistically significant difference was seen between the study groups with regard to age, sex, risk factors, American Society of Anesthesiologists (ASA) grade, or diameter of aneurysm repaired. All emergency, urgent, and endovascular procedures for aneurysms were excluded. Fifty-seven patients received iloprost infusion for 72 hr in the immediate postoperative period compared with 47 patients who did not. Patients were monitored for signs of pulmonary, renal, cardiac, systemic ischemia, and postoperative intensive care unit (ICU) morbidity. Statistically significantly increased ventilation rates (p=0.0048), pulmonary complication rates (p=0.0019), and myocardial ischemia (p=0.0446) were noted in those patients not receiving iloprost. These patients also had significantly higher renal indices including estimate glomerular filtration rate changes (p=0.041) and postoperative urea level rises (p=0.0286). Peripheral limb trashing was noted in five patients (11.6%) in the non-iloprost group compared with no patients who received iloprost. Increased rates of transfusion requirements and bowel complications were noted in those who did not receive iloprost, with their ICU stay greater than twice that of iloprost patients. All-cause morbidity affected 67% of patients not receiving iloprost compared to 40% who did

  4. School-based mindfulness intervention for stress reduction in adolescents: Design and methodology of an open-label, parallel group, randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Jeanette M. Johnstone

    2016-12-01

    Full Text Available Adolescents are in a high-risk period developmentally, in terms of susceptibility to stress. A mindfulness intervention represents a potentially useful strategy for developing cognitive and emotion regulation skills associated with successful stress coping. Mindfulness strategies have been used successfully for emotional coping in adults, but are not as well studied in youth. This article details a novel proposal for the design of an 8-week randomized study to evaluate a high school-based mindfulness curriculum delivered as part of a two semester health class. A wellness education intervention is proposed as an active control, along with a waitlist control condition. All students enrolled in a sophomore (10th grade health class at a private suburban high school will be invited to participate (n = 300. Pre-test assessments will be obtained by youth report, parent ratings, and on-site behavioral testing. The assessments will evaluate baseline stress, mood, emotional coping, controlled attention, and working memory. Participants, divided into 13 classrooms, will be randomized into one of three conditions, by classroom: A mindfulness intervention, an active control (wellness education, and a passive control (waitlist. Waitlisted participants will receive one of the interventions in the following term. Intervention groups will meet weekly for 8 weeks during regularly scheduled health classes. Immediate post-tests will be conducted, followed by a 60-day post-test. It is hypothesized that the mindfulness intervention will outperform the other conditions with regard to the adolescents' mood, attention and response to stress.

  5. Incontinence and Nocturia in Older Adults After Hip Fracture: Analysis of a Secondary Outcome for a Parallel Group, Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Enav Z. Zusman MSc

    2017-05-01

    Full Text Available Objective: To test the effect of a follow-up clinic on urinary incontinence (UI and nocturia among older adults with hip fracture. Method: Fifty-three older adults (≥65 years 3 to 12 months following hip fracture were enrolled and randomized to receive usual care plus the intervention (B4, or usual care (UC only. The B4 group received management by health professionals, with need-based referrals. UI, nocturia, and quality of life were measured with questionnaires at baseline, 6 months, and 12 months. Results: There were 48 participants included in this analysis, and at baseline, 44% of study participants self-reported UI. At final assessment, six out of 24 B4 participants and 12 out of 24 UC participants reported UI. Four out of five study participants reported nocturia at baseline; this did not decrease during the study. Discussion : Following hip fracture, many older adults report UI and most report nocturia. Health professionals should be aware of the high occurrence of urinary symptoms among older adults post hip fracture.

  6. Safety and pharmacokinetics of single and multiple intravenous bolus doses of diclofenac sodium compared with oral diclofenac potassium 50 mg: A randomized, parallel-group, single-center study in healthy subjects.

    Science.gov (United States)

    Munjal, Sagar; Gautam, Anirudh; Okumu, Franklin; McDowell, James; Allenby, Kent

    2016-01-01

    In a randomized, parallel-group, single-center study in 42 healthy adults, the safety and pharmacokinetic parameters of an intravenous formulation of 18.75 and 37.5 mg diclofenac sodium (DFP-08) following single- and multiple-dose bolus administration were compared with diclofenac potassium 50 mg oral tablets. Mean AUC0-inf values for a 50-mg oral tablet and an 18.75-mg intravenous formulation were similar (1308.9 [393.0]) vs 1232.4 [147.6]). As measured by the AUC, DFP-08 18.75 mg and 37.5 mg demonstrated dose proportionality for extent of exposure. One subject in each of the placebo and DFP-08 18.75-mg groups and 2 subjects in the DFP-08 37.5-mg group reported adverse events that were considered by the investigator to be related to the study drug. All were mild in intensity and did not require treatment. Two subjects in the placebo group and 1 subject in the DFP-08 18.75-mg group reported grade 1 thrombophlebitis; no subjects reported higher than grade 1 thrombophlebitis after receiving a single intravenous dose. The 18.75- and 37.5-mg doses of intravenous diclofenac (single and multiple) were well tolerated for 7 days. Additional efficacy and safety studies are required to fully characterize the product. © 2015, The American College of Clinical Pharmacology.

  7. A Randomized, Double-blind, Placebo-controlled, Parallel-group, Pilot Study of Cannabidiol-rich Botanical Extract in the Symptomatic Treatment of Ulcerative Colitis.

    Science.gov (United States)

    Irving, Peter M; Iqbal, Tariq; Nwokolo, Chuka; Subramanian, Sreedhar; Bloom, Stuart; Prasad, Neeraj; Hart, Ailsa; Murray, Charles; Lindsay, James O; Taylor, Adam; Barron, Rachel; Wright, Stephen

    2018-03-19

    Cannabidiol (CBD) exhibits anti-inflammatory properties that could improve disease activity in inflammatory bowel disease. This proof-of-concept study assessed efficacy, safety and tolerability of CBD-rich botanical extract in ulcerative colitis (UC) patients. Patients aged 18 years or older, with left-sided or extensive UC, Mayo scores of 4-10 (endoscopy scores ≥1), and on stable 5-aminosalicylic acid dosing, were randomized to 10-weeks' CBD-rich botanical extract or placebo capsules. The primary endpoint was the percentage of patients in remission after treatment. Statistical testing was 2-sided, using a 10% significance level. Patients were less tolerant of CBD-rich botanical extract compared with placebo, taking on average one-third fewer capsules, and having more compliance-related protocol deviations (principally insufficient exposure), prompting identification of a per protocol (PP) analysis set. The primary endpoint was negative; end of treatment remission rates were similar for CBD-rich botanical extract (28%) and placebo (26%). However, PP analysis of total and partial Mayo scores favoured CBD-rich botanical extract (P = 0.068 and P = 0.038, respectively). Additionally, PP analyses of the more subjective physician's global assessment of illness severity, subject global impression of change, and patient-reported quality-of-life outcomes were improved for patients taking CBD-rich botanical extract (P = 0.069, P = 0.003, and P = 0.065, respectively). Adverse events (AEs) were predominantly mild/moderate with many in the CBD-rich botanical extract group potentially attributable to the ∆9-tetrahydrocannabinol content. A greater proportion of gastrointestinal-related AEs, indicative of UC worsening, was seen on placebo. Although the primary endpoint was not reached, several signals suggest CBD-rich botanical extract may be beneficial for symptomatic treatment of UC.

  8. The effect of Helicobacter pylori infection and eradication in patients with gastro-oesophageal reflux disease: A parallel-group, double-blind, placebo-controlled multicentre study.

    Science.gov (United States)

    Schwizer, Werner; Menne, Dieter; Schütze, Kurt; Vieth, Michael; Goergens, Reiner; Malfertheiner, Peter; Leodolter, Andreas; Fried, Michael; Fox, Mark R

    2013-08-01

    This study aimed to resolve controversy regarding the effects of Helicobacter pylori eradication therapy and H. pylori infection in gastro-oesophageal reflux disease. A randomized, double-blind, multicentre trial was performed in patients presenting with reflux symptoms. H. pylori-positive patients were randomized to receive either antibiotics or placebo for 7 days. H. pylori-negative patient controls received placebo. All received esomeprazole 20 mg b.d. for 7 days, followed by 40 mg o.d. to complete an 8-week course, and were followed up for 32 weeks by telephone. In this study, 198/589 (34%) patients were H. pylori-positive and 113 H. pylori-negative patients served as controls. Baseline endoscopy revealed 63% Los Angeles grade 0A and 37% Los Angeles grade BCD oesophagitis with no difference between patient groups. Symptom improvement on esomeprazole was seen in 89%. H. pylori eradication was successful in 82%. H. pylori eradication had no effect on symptomatic relapse (hazard ratio 1.15, 95% CI 0.74-1.8; p = 0.5). Overall, H. pylori-positive patients had a lower probability of relapse compared to H. pylori-negative controls (hazard ratio 0.6, 95% CI 0.43-0.85; p = 0.004). Relapse hazard was modulated also by oesophagitis grade (BCD vs. 0A, hazard ratio 2.1, 95% CI 1.5-3.0). Relapse of gastro-oesophageal reflux disease symptoms after a course of high dose acid suppression took longer for H. pylori-positive patients than H. pylori-negative controls; however eradication therapy had no effect on the risk of relapse; ClincialTrials.gov number, NCT00574925.

  9. Double-blind,parallel group, placebo-controlledstudy of Kjellmaniella crassifoliaMiyabe (Gagomein human: The potential of Gagometoactivatethe immune system

    Directory of Open Access Journals (Sweden)

    Jun Nishihira

    2017-10-01

    Full Text Available Background: Marine brown algae, Kjellmaniella crassifolia Miyabe (Gagome is extensively harvested in Northern Japan and is known to help improve the immune system and prevent lifestyle diseases by its functional constituents, particularly the polysaccharide fucoidan. However, since most scientific findings come from animal studies, we examined its potential effectiveness in humans to raise immune functions, using small amounts of Gagome to avoid overconsumption of iodide. Methods: We set up a double-blind, placebo-controlled clinical trial (n=30 subjects for Gagome consumption; n=30 for placebo, in which 0.8 gram/day of Gagome containing 200 mg as dietary fiber (ca. 80 mg as fucoidan was ingested for 8 weeks. The primary end-point was natural killer (NK cell activity while other immune-related biomarkers, such as immunoglobulins (IgM and IgA and cytokines (IL-12 and IFN-g were secondary end-points. Results: No adverse effects were observed during the course of the clinical trial. We found that 8-week daily Gagome intake raised NK cell activities for the group with a relatively higher baseline number of NK cells (p=0.03. We also demonstrated that Gagome intake exerted a tendency to stimulate IgA secretion. These results indicate the possibility that Gagome intake may potentiate host defense systems in human as seen in animal studies. Conclusion: In this study, we used small amounts of Gagome (0.8 g daily as an active test sample to avoid overconsumption of iodide, and found that this amount could enhance NK cell activities, particularly in the subclass with initially higher NK cell numbers. We also found an appreciable increment of IgA. With all of these facts, it seems that Gagome intake activates immune responses that contribute to the promotion of health through stimulation of the immune system.

  10. Shock wave lithotripsy outcomes for lower pole and non-lower pole stones from a university teaching hospital: Parallel group comparison during the same time period

    Science.gov (United States)

    Geraghty, Robert; Burr, Jacob; Simmonds, Nick; Somani, Bhaskar K.

    2015-01-01

    Introduction: Shock wave lithotripsy (SWL) is a treatment option for all locations of renal and ureteric stones. We compared the results of SWL for lower pole renal stones with all other non-lower pole renal and ureteric stones during the same time period. Material and Methods: All SWL procedures were carried out as day case procedures by a mobile lithotripter from January 2012 to August 2013. The follow-up imaging was a combination of KUB X-ray or USS. Following SWL treatment, the stone free rate (SFR) was defined as ≤3 mm fragments. Results: A total of 148 patients with a mean age of 62 years underwent 201 procedures. Of the 201 procedures, 93 (46%) were for lower pole stones. The non-lower pole stones included upper pole (n = 36), mid pole (n = 40), renal pelvis (n = 10), PUJ (n = 8), mid ureter (n = 3), upper ureter (n = 5) and a combination of upper, middle and/or lower pole (n = 6). The mean stone size for lower pole stones (7.4 mm; range: 4-16 mm) was slightly smaller than non-lower pole stones (8 mm; range: 4-17 mm). The stone fragmentation was successful in 124 (62%) of patients. However, the SFR was statistically significantly better (P = 0.023) for non-lower pole stones 43 (40%) compared to lower pole stones 23 (25%). There were 9 (4%) minor complications and this was not significantly different in the two groups. Conclusions: Although SWL achieves a moderately high stone fragmentation rate with a low complication rate, the SFR is variable depending on the location of stone and the definition of SFR, with lower pole stones fairing significantly worse than stones in all other locations. PMID:25657543

  11. Effect of women’s groups and volunteer peer counselling on rates of mortality, morbidity, and health behaviours in mothers and children in rural Malawi (MaiMwana): a factorial, cluster-randomised controlled trial

    Science.gov (United States)

    Lewycka, Sonia; Mwansambo, Charles; Rosato, Mikey; Kazembe, Peter; Phiri, Tambosi; Mganga, Andrew; Chapota, Hilda; Malamba, Florida; Kainja, Esther; Newell, Marie-Louise; Greco, Giulia; Pulkki-Brännström, Anni-Maria; Skordis-Worrall, Jolene; Vergnano, Stefania; Osrin, David; Costello, Anthony

    2013-01-01

    Summary Background Women’s groups and health education by peer counsellors can improve the health of mothers and children. We assessed their effects on mortality and breastfeeding rates in rural Malawi. Methods We did a 2×2 factorial, cluster-randomised trial in 185 888 people in Mchinji district. 48 equal-sized clusters were randomly allocated to four groups with a computer-generated number sequence. 24 facilitators guided groups through a community action cycle to tackle maternal and child health problems. 72 trained volunteer peer counsellors made home visits at five timepoints during pregnancy and after birth to support breastfeeding and infant care. Primary outcomes for the women’s group intervention were maternal, perinatal, neonatal, and infant mortality rates (MMR, PMR, NMR, and IMR, respectively); and for the peer counselling were IMR and exclusive breastfeeding (EBF) rates. Analysis was by intention to treat. The trial is registered as ISRCTN06477126. Findings We monitored outcomes of 26 262 births between 2005 and 2009. In a factorial model adjusted only for clustering and the volunteer peer counselling intervention, in women’s group areas, for years 2 and 3, we noted non-significant decreases in NMR (odds ratio 0·93, 0·64–1·35) and MMR (0·54, 0·28–1·04). After adjustment for parity, socioeconomic quintile, and baseline measures, effects were larger for NMR (0·85, 0·59–1·22) and MMR (0·48, 0·26–0·91). Because of the interaction between the two interventions, a stratified analysis was done. For women’s groups, in adjusted analyses, MMR fell by 74% (0·26, 0·10–0·70), and NMR by 41% (0·59, 0·40–0·86) in areas with no peer counsellors, but there was no effect in areas with counsellors (1·09, 0·40–2·98, and 1·38, 0·75–2·54). Factorial analysis for the peer counselling intervention for years 1–3 showed a fall in IMR of 18% (0·82, 0·67–1·00) and an improvement in EBF rates (2·42, 1·48–3·96). The

  12. DupuytrEn Treatment EffeCtiveness Trial (DETECT): a protocol for prospective, randomised, controlled, outcome assessor-blinded, three-armed parallel 1:1:1, multicentre trial comparing the effectiveness and cost of collagenase clostridium histolyticum, percutaneous needle fasciotomy and limited fasciectomy as short-term and long-term treatment strategies in Dupuytren's contracture.

    Science.gov (United States)

    Räisänen, Mikko P; Karjalainen, Teemu; Göransson, Harry; Reito, Aleksi; Kautiainen, Hannu; Malmivaara, Antti; Leppänen, Olli V

    2018-03-28

    Dupuytren's contracture (DC) is a chronic fibroproliferative disorder of the palmar fascia which leads to flexion contracture in one or more fingers. There is no definitive cure for DC, and treatment aims at relieving symptoms by releasing the contracture using percutaneous or operative techniques. We planned a prospective, randomised, controlled, outcome assessor-blinded, three-armed parallel 1:1:1, multicentre trial comparing the effectiveness and cost of (1) collagenase clostridium histolyticum injection followed by limited fasciectomy in non-responsive cases, (2) percutaneous needle fasciotomy followed by limited fasciectomy in non-responsive cases and (3) primary limited fasciectomy during short-term and long-term follow-up for Tubiana I-III stages DC. We will recruit participants from seven national centres in Finland. Primary outcome is the rate of success in the treatment arm at 5 years after recruitment. Success is a composite outcome comprising (1) at least 50% contracture release from the date of recruitment and (2) participants in a patient-accepted symptom state (PASS). Secondary outcomes are (1) angle of contracture, (2) quick disabilities of the arm, a shoulder and hand outcome measure (QuickDASH), (3) perceived hand function, (4) EQ-5D-3L, (5) rate of major adverse events, (6) patient's trust of the treatment, (7) global rating, (8) rate of PASS, (9) rate of minimal clinically important improvement, (10) expenses, (11) progression of disease, (12) progression-free survival, (13) favoured treatment modality, (14) patients achieving full contracture release and >50% improvement and (15) patient satisfaction with the treatment effect. Predictive factors for achieving the PASS will also be analysed. The protocol was approved by the Tampere University Hospital Institutional Review Board and Finnish Medicine Agency. The study will be performed according to the principles of good clinical practice. The results of the trial will be disseminated as

  13. Pharmacokinetic comparison of acetaminophen elixir versus suppositories in vaccinated infants (aged 3 to 36 months): a single-dose, open-label, randomized, parallel-group design.

    Science.gov (United States)

    Walson, Philip D; Halvorsen, Mark; Edge, James; Casavant, Marcel J; Kelley, Michael T

    2013-02-01

    Because of practical problems and ethical concerns, few studies of the pharmacokinetics (PK) of acetaminophen (ACET) in infants have been published. The goal of this study was to compare the PK of an ACET rectal suppository with a commercially available ACET elixir to complete a regulatory obligation to market the suppository. This study was not submitted previously because of numerous obstacles related to both the investigators and the commercial entities associated with the tested product. Thirty infants (age 3-36 months) prescribed ACET for either fever, pain, or postimmunization prophylaxis of fever and discomfort were randomized to receive a single 10- to 15-mg/kg ACET dose either as the rectal suppository or oral elixir. Blood was collected at selected times for up to 8 hours after administration. ACET concentrations were measured by using a validated HPLC method, and PK behavior and bioavailability were compared for the 2 preparations. All 30 infants enrolled were prescribed ACET for postimmunization prophylaxis. PK samples were available in 27 of the 30 enrolled infants. Subject enrollment (completed in January 1995) was rapid (8.3 months) and drawn entirely from a vaccinated infant clinic population. There were no statistically significant differences between the subjects (elixir, n = 12; suppository, n = 15) in either mean (SD) age (10.0 [6.3] vs 12.4 [8.1] months), weight (8.6 [2.3] vs 9.4 [2.4] kg), sex (7 of 12 males vs 7 of 15 males), or racial distribution (5 white, 5 black, and 2 biracial vs 4 white and 11 black) between the 2 dosing groups (oral vs rectal, respectively). The oral and rectal preparations produced similar, rapid peak concentrations (T(max), 1.16 vs 1.17 hours; P = 0.98) and elimination t(½) (1.84 vs 2.10 hours; P = 0.14), respectively. No statistically significant differences were found between either C(max) (7.65 vs 5.68 μg/mL) or total drug exposure (AUC(0-∞), 23.36 vs 20.45 μg-h/mL) for the oral versus rectal preparations

  14. Parallel Programming with Intel Parallel Studio XE

    CERN Document Server

    Blair-Chappell , Stephen

    2012-01-01

    Optimize code for multi-core processors with Intel's Parallel Studio Parallel programming is rapidly becoming a "must-know" skill for developers. Yet, where to start? This teach-yourself tutorial is an ideal starting point for developers who already know Windows C and C++ and are eager to add parallelism to their code. With a focus on applying tools, techniques, and language extensions to implement parallelism, this essential resource teaches you how to write programs for multicore and leverage the power of multicore in your programs. Sharing hands-on case studies and real-world examples, the

  15. Effectiveness of a ?Workshop on Decluttering and Organising? programme for teens and middle-aged adults with difficulty decluttering: a study protocol of an open-label, randomised, parallel-group, superiority trial in Japan

    OpenAIRE

    Aso, Yasuko; Yamaoka, Kazue; Nemoto, Asuka; Naganuma, Yuki; Saito, Masashige

    2017-01-01

    Introduction Hoarding disorder can cause problems with work performance, personal hygiene, health and well-being. The disorder is a growing social problem in Japan. Having difficulty discarding rubbish, decluttering and organising can signal a future hoarding disorder, and early intervention is important. We developed an educational workshop on decluttering and organising for teens and adults with difficulty organising. The objective of this study is to evaluate the effectiveness of a worksho...

  16. Rasagiline as an adjunct to levodopa in patients with Parkinson's disease and motor fluctuations (LARGO, Lasting effect in Adjunct therapy with Rasagiline Given Once daily, study): a randomised, double-blind, parallel-group trial.

    Science.gov (United States)

    Rascol, O; Brooks, D J; Melamed, E; Oertel, W; Poewe, W; Stocchi, F; Tolosa, E

    Rasagiline mesylate is a novel drug for Parkinson's disease with selective, irreversible monoamine oxidase B (MAO-B) inhibitor activity, and is effective as monotherapy in early disease. This study investigated rasagiline efficacy and safety in levodopa-treated patients with Parkinson's disease and motor fluctuations. In an 18-week, double-blind, multicentre (74 hospitals and academic centres in Israel, Argentina, and Europe) trial, 687 outpatients were randomly assigned to oral rasagiline (231 individuals; 1 mg once daily), entacapone (227; 200 mg with every levodopa dose), or placebo (229). Primary outcome was change in total daily off-time (intention-to-treat population). Other measures included the clinical global improvement (CGI) score and unified Parkinson's disease rating scale (UPDRS) scores. Analysis was by intention to treat. 88 (13%) patients who were assigned treatment did not complete the study (23 rasagiline, 30 entacapone, 35 placebo), mainly because of withdrawal of consent (n=34) and adverse events (n=34). Both rasagiline and entacapone reduced mean daily off-time (-1.18 h rasagiline and -1.2 h entacapone vs placebo -0.4 h; p=0.0001, prasagiline and -0.72 entacapone vs -0.37 placebo; prasagiline reduces mean daily off-time and improves symptoms of Parkinson's disease in levodopa-treated patients with motor fluctuations, an effect similar to that of entacapone.

  17. A cluster-randomised, parallel group, controlled intervention study of genetic prostate cancer risk assessment and use of PSA tests in general practice--the ProCaRis study

    DEFF Research Database (Denmark)

    Kirkegaard, Pia; Vedsted, Peter; Edwards, Adrian

    2013-01-01

    PSA-testen er det bedste og mest anvendte værktøj til at opspore prostatacancer. Testen er dog behæftet med fejlkilder, som kan føre til overflødig udredning, diagnosticering og behandling. Ved udredning tages biopsier med risiko for behandlingskrævende infektion. Behandlingen for prostatacancer...... fører ofte til vandladningsproblemer og impotens, og den har ikke vist sig specielt effektiv i behandling af den aggressive prostatacancer. Risikoen for overdiagnostik og overbehandling betyder, at PSA-testen ikke anvendes til generel screening for prostatakræft. Alligevel får mange patienter taget en...... PSA-test - ofte flere gange - måske fordi de ser sig selv som værende i særlig risiko. I ProCaRis-studiet får udvalgte praksis i Region Midtjylland mulighed for at tilbyde en genetisk risikovurdering for prostatakræft til patienter, som skal have en PSA-test. Den genetiske risikovurdering kan afgøre...

  18. Methylprednisolone in combination with interferon beta-1a for relapsing-remitting multiple sclerosis (MECOMBIN study): a multicentre, double-blind, randomised, placebo-controlled, parallel-group trial

    DEFF Research Database (Denmark)

    Ravnborg, Mads; Sørensen, Per Soelberg; Andersson, Magnus

    2010-01-01

    status scale (EDSS) score of 4 or less. Patients all started to receive interferon beta-1a and after 3 months were randomly assigned to add-on methylprednisolone or placebo 500 mg/day orally for 3 consecutive days per month for 3-4 years. Placebo tablets were identical to methylprednisolone tablets....... Treating physicians, examining physicians, and patients were masked to treatment allocation. Patients were clinically assessed every 3 months and had brain MRI at baseline and 3 years later. The primary outcome was time to onset of disability progression, according to an increase in EDSS score sustained...

  19. 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.

  20. Multicenter, double-blind, parallel group study investigating the non-inferiority of efficacy and safety of a 2% miconazole nitrate shampoo in comparison with a 2% ketoconazole shampoo in the treatment of seborrhoeic dermatitis of the scalp.

    Science.gov (United States)

    Buechner, Stanislaw A

    2014-06-01

    This study investigated the non-inferiority of efficacy and tolerance of 2% miconazole nitrate shampoo in comparison with 2% ketoconazole shampoo in the treatment of scalp seborrheic dermatitis. A randomized, double-blind, comparative, parallel group, multicenter study was done. A total of 274 patients (145 miconazole, 129 ketoconazole) were enrolled. Treatment was twice-weekly for 4 weeks. Safety and efficacy assessments were made at baseline and at weeks 2 and 4. Assessments included symptoms of erythema, itching, scaling ['Symptom Scale of Seborrhoeic Dermatitis' (SSSD)], disease severity and global change [Clinical Global Impressions (CGIs) and Patient Global Impressions (PGIs)]. Miconazole shampoo is at least as effective and safe as ketoconazole shampoo in treating scalp seborrheic dermatitis scalp.

  1. Minocycline versus co-trimoxazole in chancroid : A double-blind randomised study

    Directory of Open Access Journals (Sweden)

    Oberoi C

    1994-01-01

    Full Text Available This double-blind randomised parallel-group study comparing the efficacy and side effects of minocycline with that of cotrimoxazole in chancroid, had 56 analysable cases, 28 in each group. All admissible cases were assessed clinically on a scale of 0 to 3 for number and size of ulcers, pain, discharge, surrounding erythema and bubo. Each drug individually showed significant improvement in all clinical parameters. Minocycline showed significantly better improvement than cotrimoxazole in all parameters. Minocycline had 43% cure rate, and no failures, against 36% cure and 25% failure for cotrimoxazole. Both the drug were well tolerated. We conclude that minocycline is a superior alternative to cotrimoxazole in the therapy of chancroid.

  2. Efficacy of treatment of insomnia in migraineurs with eszopiclone (Lunesta®) and its effect on total sleep time, headache frequency, and daytime functioning: A randomized, double-blind, placebo-controlled, parallel-group, pilot study.

    Science.gov (United States)

    Spierings, Egilius L H; McAllister, Peter J; Bilchik, Tanya R

    2015-04-01

    A review on headache and insomnia revealed that insomnia is a risk factor for increased headache frequency and headache intensity in migraineurs. The authors designed a randomized, double blind, placebo-controlled, parallel-group, pilot study in which migraineurs who also had insomnia were enrolled, to test this observation. In the study, the authors treated 79 subjects with IHS-II migraine with and/or without aura and with DSM-IV primary insomnia for 6 weeks with 3 mg eszopiclone (Lunesta(®)) or placebo at bedtime. The treatment was preceded by a 2-week baseline period and followed by a 2-week run-out period. Of the 79 subjects treated, 75 were evaluable, 35 in the eszopiclone group, and 40 in the placebo group. At baseline, the groups were comparable except for sleep latency. Of the three remaining sleep variables, total sleep time, nighttime awakenings, and sleep quality, the number of nighttime awakenings during the 6-week treatment period was significantly lower in the eszopiclone group than in the placebo group (P = 0.03). Of the three daytime variables, alertness, fatigue, and functioning, this was also the case for fatigue (P = 005). The headache variables, frequency, duration, and intensity, did not show a difference from placebo during the 6-week treatment period. The study did not meet primary endpoint, that is, the difference in total sleep time during the 6-week treatment period between eszopiclone and placebo was less than 40 minutes. Therefore, it failed to answer the question as to whether insomnia is, indeed, a risk factor for increased headache frequency and headache intensity in migraineurs.

  3. Twelve-week, multicenter, placebo-controlled, randomized, double-blind, parallel-group, comparative phase II/III study of benzoyl peroxide gel in patients with acne vulgaris: A secondary publication.

    Science.gov (United States)

    Kawashima, Makoto; Sato, Shinichi; Furukawa, Fukumi; Matsunaga, Kayoko; Akamatsu, Hirohiko; Igarashi, Atsuyuki; Tsunemi, Yuichiro; Hayashi, Nobukazu; Yamamoto, Yuki; Nagare, Toshitaka; Katsuramaki, Tsuneo

    2017-07-01

    A placebo-controlled, randomized, double-blind, parallel-group, comparative, multicenter study was conducted to investigate the efficacy and safety of benzoyl peroxide (BPO) gel, administrated once daily for 12 weeks to Japanese patients with acne vulgaris. Efficacy was evaluated by counting all inflammatory and non-inflammatory lesions. Safety was evaluated based on adverse events, local skin tolerability scores and laboratory test values. All 609 subjects were randomly assigned to receive the study products (2.5% and 5% BPO and placebo), and 607 subjects were included in the full analysis set, 544 in the per protocol set and 609 in the safety analyses. The median rates of reduction from baseline to the last evaluation of the inflammatory lesion counts, the primary end-point, in the 2.5% and 5% BPO groups were 72.7% and 75.0%, respectively, and were significantly higher than that in the placebo group (41.7%). No deaths or other serious adverse events were observed. The incidences of adverse events in the 2.5% and 5% BPO groups were 56.4% and 58.8%, respectively; a higher incidence than in the placebo group, but there was no obvious difference between the 2.5% and 5% BPO groups. All adverse events were mild or moderate in severity. Most adverse events did not lead to study product discontinuation. The results suggested that both 2.5% and 5% BPO are useful for the treatment of acne vulgaris. © 2017 The Authors. The Journal of Dermatology published by John Wiley & Sons Australia, Ltd.

  4. Clinical and economic evaluation of laparoscopic surgery compared with medical management for gastro-oesophageal reflux disease: 5-year follow-up of multicentre randomised trial (the REFLUX trial).

    Science.gov (United States)

    Grant, A M; Boachie, C; Cotton, S C; Faria, R; Bojke, L; Epstein, D M; Ramsay, C R; Corbacho, B; Sculpher, M; Krukowski, Z H; Heading, R C; Campbell, M K

    2013-06-01

    Despite promising evidence that laparoscopic fundoplication provides better short-term relief of gastro-oesophageal reflux disease (GORD) than continued medical management, uncertainty remains about whether benefits are sustained and outweigh risks. To evaluate the long-term clinical effectiveness, cost-effectiveness and safety of laparoscopic surgery among people with GORD requiring long-term medication and suitable for both surgical and medical management. Five-year follow-up of a randomised trial (with parallel non-randomised preference groups) comparing a laparoscopic surgery-based policy with a continued medical management policy. Cost-effectiveness was assessed alongside the trial using a NHS perspective for costs and expressing health outcomes in terms of quality-adjusted life-years (QALYs). Follow-up was by annual postal questionnaire and selective hospital case notes review; initial recruitment in 21 UK hospitals. Questionnaire responders among the 810 original participants. At entry, all had documented evidence of GORD and symptoms for > 12 months. Questionnaire response rates (years 1-5) were from 89.5% to 68.9%. Three hundred and fifty-seven participants were recruited to the randomised comparison (178 randomised to surgical management and 179 randomised to continued medical management) and 453 to the preference groups (261 surgical management and 192 medical management). The surgeon chose the type of fundoplication. Primary: disease-specific outcome measure (the REFLUX questionnaire); secondary: Short Form questionnaire-36 items (SF-36), European Quality of Life-5 Dimensions (EQ-5D), NHS resource use, reflux medication, complications. The randomised groups were well balanced. By 5 years, 63% in the randomised surgical group and 13% in the randomised medical management group had received a total or partial wrap fundoplication (85% and 3% in the preference groups), with few perioperative complications and no associated deaths. At 1 year (and 5 years

  5. Design paper: The CapOpus trial: A randomized, parallel-group, observer-blinded clinical trial of specialized addiction treatment versus treatment as usual for young patients with cannabis abuse and psychosis

    Directory of Open Access Journals (Sweden)

    Gluud Christian

    2008-07-01

    Full Text Available Abstract Background A number of studies indicate a link between cannabis-use and psychosis as well as more severe psychosis in those with existing psychotic disorders. There is currently insufficient evidence to decide the optimal way to treat cannabis abuse among patients with psychosis. Objectives The major objective for the CapOpus trial is to evaluate the additional effect on cannabis abuse of a specialized addiction treatment program adding group treatment and motivational interviewing to treatment as usual. Design The trial is designed as a randomized, parallel-group, observer-blinded clinical trial. Patients are primarily recruited through early-psychosis detection teams, community mental health centers, and assertive community treatment teams. Patients are randomized to one of two treatment arms, both lasting six months: 1 specialized addiction treatment plus treatment as usual or 2 treatment as usual. The specialized addiction treatment is manualized and consists of both individual and group-based motivational interviewing and cognitive behavioral therapy, and incorporates both the family and the case manager of the patient. The primary outcome measure will be changes in amount of cannabis consumption over time. Other outcome measures will be psychosis symptoms, cognitive functioning, quality of life, social functioning, and cost-benefit analyses. Trial registration ClinicalTrials.gov NCT00484302.

  6. Isoflavones, calcium, vitamin D and inulin improve quality of life, sexual function, body composition and metabolic parameters in menopausal women: result from a prospective, randomized, placebo-controlled, parallel-group study.

    Science.gov (United States)

    Vitale, Salvatore Giovanni; Caruso, Salvatore; Rapisarda, Agnese Maria Chiara; Cianci, Stefano; Cianci, Antonio

    2018-03-01

    Menopause results in metabolic changes that contribute to increase risk of cardiovascular diseases: increase in low density lipoprotein (LDL) and triglycerides and decrease in high density lipoprotein (HDL), weight gain are associated with a correspondent increase in incidence of hypertension and diabetes. The aim of this study was to evaluate the effect of a preparation of isoflavones, calcium vitamin D and inulin in menopausal women. We performed a prospective, randomized, placebo-controlled, parallel-group study. A total of 50 patients were randomized to receive either oral preparations of isoflavones (40 mg), calcium (500 mg) vitamin D (300 UI) and inulin (3 g) or placebo (control group). Pre- and post-treatment assessment of quality of life and sexual function were performed through Menopause-Specific Quality of Life Questionnaire (MENQOL) and Female Sexual Function Index (FSFI); evaluations of anthropometric indicators, body composition through bioelectrical impedance analyser, lumbar spine and proximal femur T-score and lipid profile were performed. After 12 months, a significant reduction in MENQOL vasomotor, physical and sexual domain scores ( p 0.05) were found in the same group. According to our data analysis, isoflavones, calcium, vitamin D and inulin may exert favourable effects on menopausal symptoms and signs.

  7. Patient education with or without manual therapy compared to a control group in patients with osteoarthritis of the hip. A proof-of-principle three-arm parallel group randomized clinical trial.

    Science.gov (United States)

    Poulsen, E; Hartvigsen, J; Christensen, H W; Roos, E M; Vach, W; Overgaard, S

    2013-10-01

    To investigate the effectiveness of a patient education (PE) program with or without the added effect of manual therapy (MT) compared to a minimal control intervention (MCI). In a single-center university hospital setting, a total of 118 patients with clinical and radiographic unilateral hip osteoarthritis (OA) from primary care were randomized into one of three groups: PE, PE plus MT or MCI. The PE was taught by a physiotherapist involving five sessions. The MT was delivered by a chiropractor involving 12 sessions and the MCI included a home stretching program. Primary outcome was self-reported pain severity on an 11-box numeric rating scale (NRS) immediately following a 6-week intervention period. Patients were followed for 1 year. Primary analysis included 111 patients (94%). In the combined group (PE + MT), a clinically relevant reduction in pain severity compared to the MCI of 1.90 points (95% confidence interval (CI) 0.9-2.9) was achieved. Effect size (Cohen's d) for the PE + MT minus the MCI was 0.92 (95% CI 0.41-1.42). Number needed to treat for PE + MT was 3 (95% CI 2-7). No difference was found between the PE and MCI groups, with mean difference 0.0 (95% CI -1.0 to 1.0). At 12 months, not including patients receiving hip surgery the statistically significant difference favoring PE + MT was maintained. For primary care patients with OA of the hip, a combined intervention of MT and PE was more effective than a MCI. PE alone was not superior to the MCI. clinicaltrials.govNCT01039337. Copyright © 2013 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

  8. Practical parallel computing

    CERN Document Server

    Morse, H Stephen

    1994-01-01

    Practical Parallel Computing provides information pertinent to the fundamental aspects of high-performance parallel processing. This book discusses the development of parallel applications on a variety of equipment.Organized into three parts encompassing 12 chapters, this book begins with an overview of the technology trends that converge to favor massively parallel hardware over traditional mainframes and vector machines. This text then gives a tutorial introduction to parallel hardware architectures. Other chapters provide worked-out examples of programs using several parallel languages. Thi

  9. Parallel sorting algorithms

    CERN Document Server

    Akl, Selim G

    1985-01-01

    Parallel Sorting Algorithms explains how to use parallel algorithms to sort a sequence of items on a variety of parallel computers. The book reviews the sorting problem, the parallel models of computation, parallel algorithms, and the lower bounds on the parallel sorting problems. The text also presents twenty different algorithms, such as linear arrays, mesh-connected computers, cube-connected computers. Another example where algorithm can be applied is on the shared-memory SIMD (single instruction stream multiple data stream) computers in which the whole sequence to be sorted can fit in the

  10. Writing parallel programs that work

    CERN Multimedia

    CERN. Geneva

    2012-01-01

    Serial algorithms typically run inefficiently on parallel machines. This may sound like an obvious statement, but it is the root cause of why parallel programming is considered to be difficult. The current state of the computer industry is still that almost all programs in existence are serial. This talk will describe the techniques used in the Intel Parallel Studio to provide a developer with the tools necessary to understand the behaviors and limitations of the existing serial programs. Once the limitations are known the developer can refactor the algorithms and reanalyze the resulting programs with the tools in the Intel Parallel Studio to create parallel programs that work. About the speaker Paul Petersen is a Sr. Principal Engineer in the Software and Solutions Group (SSG) at Intel. He received a Ph.D. degree in Computer Science from the University of Illinois in 1993. After UIUC, he was employed at Kuck and Associates, Inc. (KAI) working on auto-parallelizing compiler (KAP), and was involved in th...

  11. Impact on birth weight and child growth of Participatory Learning and Action women's groups with and without transfers of food or cash during pregnancy: Findings of the low birth weight South Asia cluster-randomised controlled trial (LBWSAT in Nepal.

    Directory of Open Access Journals (Sweden)

    Naomi M Saville

    Full Text Available Undernutrition during pregnancy leads to low birthweight, poor growth and inter-generational undernutrition. We did a non-blinded cluster-randomised controlled trial in the plains districts of Dhanusha and Mahottari, Nepal to assess the impact on birthweight and weight-for-age z-scores among children aged 0-16 months of community-based participatory learning and action (PLA women's groups, with and without food or cash transfers to pregnant women.We randomly allocated 20 clusters per arm to four arms (average population/cluster = 6150. All consenting married women aged 10-49 years, who had not had tubal ligation and whose husbands had not had vasectomy, were monitored for missed menses. Between 29 Dec 2013 and 28 Feb 2015 we recruited 25,092 pregnant women to surveillance and interventions: PLA alone (n = 5626; PLA plus food (10 kg/month of fortified wheat-soya 'Super Cereal', n = 6884; PLA plus cash (NPR750≈US$7.5/month, n = 7272; control (existing government programmes, n = 5310. 539 PLA groups discussed and implemented strategies to improve low birthweight, nutrition in pregnancy and hand washing. Primary outcomes were birthweight within 72 hours of delivery and weight-for-age z-scores at endline (age 0-16 months. Only children born to permanent residents between 4 June 2014 and 20 June 2015 were eligible for intention to treat analyses (n = 10936, while in-migrating women and children born before interventions had been running for 16 weeks were excluded. Trial status: completed.In PLA plus food/cash arms, 94-97% of pregnant women attended groups and received a mean of four transfers over their pregnancies. In the PLA only arm, 49% of pregnant women attended groups. Due to unrest, the response rate for birthweight was low at 22% (n = 2087, but response rate for endline nutritional and dietary measures exceeded 83% (n = 9242. Compared to the control arm (n = 464, mean birthweight was significantly higher in the PLA plus food arm by 78·0 g

  12. Randomised clinical trial: vonoprazan, a novel potassium-competitive acid blocker, vs. lansoprazole for the healing of erosive oesophagitis.

    Science.gov (United States)

    Ashida, K; Sakurai, Y; Hori, T; Kudou, K; Nishimura, A; Hiramatsu, N; Umegaki, E; Iwakiri, K

    2016-01-01

    Vonoprazan is a novel potassium-competitive acid blocker which may provide clinical benefit in acid-related disorders. To verify the non-inferiority of vonoprazan vs. lansoprazole in patients with erosive oesophagitis (EE), and to establish its long-term safety and efficacy as maintenance therapy. In this multicentre, randomised, double-blind, parallel-group comparison study, patients with endoscopically confirmed EE (LA Classification Grades A-D) were randomly allocated to receive vonoprazan 20 mg or lansoprazole 30 mg once daily after breakfast. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy up to week 8. In addition, subjects who achieved healed EE in the comparison study were re-randomised into a long-term study to investigate the safety and efficacy of vonoprazan 10 or 20 mg as maintenance therapy for 52 weeks. Of the 409 eligible subjects randomised, 401 completed the comparison study, and 305 entered the long-term maintenance study. The proportion of patients with healed EE up to week 8 was 99.0% for vonoprazan (203/205) and 95.5% for lansoprazole (190/199), thus verifying the non-inferiority of vonoprazan (P lansoprazole in EE was verified in the comparison study, and vonoprazan was well-tolerated and effective during the long-term maintenance study. © 2015 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.

  13. Targeting young drinkers online: the effectiveness of a web-based brief alcohol intervention in reducing heavy drinking among college students: study protocol of a two-arm parallel group randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Lemmers Lex ACJ

    2011-04-01

    Full Text Available Abstract Background The prevalence of heavy drinking among college students and its associated health related consequences highlights an urgent need for alcohol prevention programs targeting 18 to 24 year olds. Nevertheless, current alcohol prevention programs in the Netherlands pay surprisingly little attention to the drinking patterns of this specific age group. The study described in this protocol will test the effectiveness of a web-based brief alcohol intervention that is aimed at reducing alcohol use among heavy drinking college students aged 18 to 24 years old. Methods/Design The effectiveness of the What Do You Drink web-based brief alcohol intervention will be tested among 908 heavy drinking college students in a two-arm parallel group randomized controlled trial. Participants will be allocated at random to either the experimental (N = 454: web-based brief alcohol intervention or control condition (N = 454: no intervention. The primary outcome measure will be the percentage of participants who drink within the normative limits of the Dutch National Health Council for low-risk drinking. These limits specify that, for heavy alcohol use, the mean consumption cannot exceed 14 or 21 glasses of standard alcohol units per week for females and males, respectively, while for binge drinking, the consumption cannot exceed five or more glasses of standard alcohol units on one drinking occasion at least once per week within one month and six months after the intervention. Reductions in mean weekly alcohol consumption and frequency of binge drinking are also primary outcome measures. Weekly Ecological Momentary Assessment will measure alcohol-related cognitions, that is, attitudes, self-efficacy, subjective norms and alcohol expectancies, which will be included as the secondary outcome measures. Discussion This study protocol describes the two-arm parallel group randomized controlled trial developed to evaluate the effectiveness of a web-based brief

  14. The efficacy and safety of lixivaptan in outpatients with heart failure and volume overload: results of a multicentre, randomized, double-blind, placebo-controlled, parallel-group study.

    Science.gov (United States)

    Ghali, Jalal K; Orlandi, Cesare; Abraham, William T

    2012-06-01

    Volume overload is the dominant feature of decompensated heart failure (HF) and it often results in adverse clinical outcomes. Vasopressin receptor antagonists such as lixivaptan may provide effective volume unloading. This study assessed weight loss after 1 day and 8 weeks of treatment with lixivaptan in outpatients with HF and volume overload. This phase II, 8-week, multicentre, double-blind, parallel-group study randomized participants (2:1) to receive lixivaptan 100 mg or placebo once daily (in addition to standard HF therapy). Body weight and cardiovascular assessments were made at baseline, Day 1 (not cardiovascular), Weeks 1, 2, 4, and 8, and 7 days post-treatment. The Trail-making Test, part B (TMT-B) and the Medical Outcomes Survey 6-item cognitive function scale (MOS-6) were assessed at baseline and Week 4. The study randomized 170 participants (lixivaptan, n = 111; placebo, n = 59). Most (97.1%) were receiving pharmacological therapy for HF at baseline. Demographic characteristics were generally similar between the two groups. Body weight decreased significantly from baseline to Day 1 with lixivaptan vs. placebo (least-square mean change ± standard error: - 0.38 ± 0.08 kg vs. +0.13 ± 0.11 kg; P overload, lixivaptan 100 mg once daily, when added to standard therapy, reduced body weight, improved dyspnoea and orthopnoea, and was well tolerated. NCT01055912.

  15. A Herbal Medicine, Gongjindan, in Subjects with Chronic Dizziness (GOODNESS Study: Study Protocol for a Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial for Effectiveness, Safety, and Cost-Effectiveness

    Directory of Open Access Journals (Sweden)

    Seungwon Shin

    2017-01-01

    Full Text Available This study protocol aims to explore the effectiveness, safety, and cost-effectiveness of a herbal medication, Gongjindan (GJD, in patients with chronic dizziness. This will be a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group, clinical trial. Seventy-eight patients diagnosed with Meniere’s disease, psychogenic dizziness, or dizziness of unknown cause will be randomized and allocated to either a GJD or a placebo group in a 1 : 1 ratio. Participants will be orally given 3.75 g GJD or placebo in pill form once a day for 56 days. The primary outcome measure will be the Dizziness Handicap Inventory score. Secondary outcome measures will be as follows: severity (mean vertigo scale and visual analogue scale and frequency of dizziness, balance function (Berg Balance Scale, fatigue (Fatigue Severity Scale and deficiency pattern/syndrome (qi blood yin yang-deficiency questionnaire levels, and depression (Korean version of Beck’s Depression Inventory and anxiety (State-Trait Anxiety Inventory levels. To assess safety, adverse events, including laboratory test results, will be monitored. Further, the incremental cost-effectiveness ratio will be calculated based on quality-adjusted life years (from the EuroQoL five dimensions’ questionnaire and medical expenses. Data will be statistically analyzed at a significance level of 0.05 (two-sided. This trial is registered with ClinicalTrials.gov NCT03219515, in July 2017.

  16. Introduction to parallel programming

    CERN Document Server

    Brawer, Steven

    1989-01-01

    Introduction to Parallel Programming focuses on the techniques, processes, methodologies, and approaches involved in parallel programming. The book first offers information on Fortran, hardware and operating system models, and processes, shared memory, and simple parallel programs. Discussions focus on processes and processors, joining processes, shared memory, time-sharing with multiple processors, hardware, loops, passing arguments in function/subroutine calls, program structure, and arithmetic expressions. The text then elaborates on basic parallel programming techniques, barriers and race

  17. Parallel computing works!

    CERN Document Server

    Fox, Geoffrey C; Messina, Guiseppe C

    2014-01-01

    A clear illustration of how parallel computers can be successfully appliedto large-scale scientific computations. This book demonstrates how avariety of applications in physics, biology, mathematics and other scienceswere implemented on real parallel computers to produce new scientificresults. It investigates issues of fine-grained parallelism relevant forfuture supercomputers with particular emphasis on hypercube architecture. The authors describe how they used an experimental approach to configuredifferent massively parallel machines, design and implement basic systemsoftware, and develop

  18. Effects on hemodynamics and gas exchange of omega-3 fatty acid-enriched lipid emulsion in acute respiratory distress syndrome (ARDS: a prospective, randomized, double-blind, parallel group study

    Directory of Open Access Journals (Sweden)

    Sacanell Judit

    2008-10-01

    Full Text Available Abstract Introduction We investigated the effects on hemodynamics and gas exchange of a lipid emulsion enriched with omega-3 fatty acids in patients with ARDS. Methods The design was a prospective, randomized, double-blind, parallel group study in our Intensive Medicine Department of Vall d'Hebron University Hospital (Barcelona-Spain. We studied 16 consecutive patients with ARDS and intolerance to enteral nutrition (14 men and 2 women; mean age: 58 ± 13 years; APACHE II score: 17.8 ± 2.3; Lung Injury Score: 3.1 ± 0.5; baseline PaO2/FiO2 ratio: 149 ± 40. Patients were randomized into 2 groups: Group A (n = 8 received the study emulsion Lipoplus® 20%, B.Braun Medical (50% MCT, 40% LCT, 10% ω-3; Group B (n = 8 received the control emulsion Intralipid® Fresenius Kabi (100% LCT. Lipid emulsions were administered during 12 h at a dose of 0.12 g/kg/h. Measurements of the main hemodynamic and gas exchange parameters were made at baseline (immediately before administration of the lipid emulsions, every hour during the lipid infusion, at the end of administration, and six hours after the end of administration lipid infusion. Results No statistically significant changes were observed in the different hemodynamic values analyzed. Likewise, the gas exchange parameters did not show statistically significant differences during the study. No adverse effect attributable to the lipid emulsions was seen in the patients analyzed. Conclusion The lipid emulsion enriched with omega-3 fatty acids was safe and well tolerated in short-term administration to patients with ARDS. It did not cause any significant changes in hemodynamic and gas exchange parameters. Trial registration ISRCTN63673813

  19. A multicentre randomised controlled trial and economic evaluation of ion-exchange water softeners for the treatment of eczema in children:the Softened Water Eczema Trial (SWET)

    OpenAIRE

    Thomas, K. S.; Koller, K.; Dean, Tara; O'Leary, C. J.; Sach, T. H.; Frost, A.; Pallett, I.; Crook, A. M.; Meredith, S.; Nunn, A. J.; Burrows, N.; Pollock, I.; Graham-Brown, R.; O'Toole, E.; Potter, D.

    2011-01-01

    Objectives: To determine whether installation of an ion-exchange water softener in the home could improve atopic eczema in children and, if so, to establish its likely cost and cost-effectiveness. Design: An observer-blind, parallel-group randomised controlled trial of 12 weeks duration followed by a 4-week observational period. Eczema was assessed by research nurses blinded to intervention at baseline, 4 weeks, 12 weeks and 16 weeks. The primary outcome was analysed as intent-to-treat, using...

  20. Effectiveness of a Guided Self-help Manual in Strengthening Resilience in People Diagnosed with Moderate Depression and Their Family Caregivers in Thailand: A Randomised Controlled Trial.

    Science.gov (United States)

    McCann, Terence V; Songprakun, Wallapa; Stephenson, John

    2017-08-01

    The growing incidence of depression in developing countries, such as Thailand, is placing increasing pressure on public mental health services, and those living in rural areas have limited access to these services. Resilience is integral to the recovery of people with depression and to caregivers. This parallel-group randomised controlled trial evaluated the effectiveness of a guided self-help manual in improving resilience in adults diagnosed with moderate depression and their primary caregivers in Thailand. Our findings provide preliminary evidence that the approach is an effective way of increasing resilience in adults with depression and their caregivers.

  1. Tackling obesity in areas of high social deprivation: clinical effectiveness and cost-effectiveness of a task-based weight management group programme - a randomised controlled trial and economic evaluation.

    Science.gov (United States)

    McRobbie, Hayden; Hajek, Peter; Peerbux, Sarrah; Kahan, Brennan C; Eldridge, Sandra; Trépel, Dominic; Parrott, Steve; Griffiths, Chris; Snuggs, Sarah; Myers Smith, Katie

    2016-10-01

    An increasing number of people require help to manage their weight. The NHS recommends weight loss advice by general practitioners and/or a referral to a practice nurse. Although this is helpful for some, more effective approaches that can be disseminated economically on a large scale are needed. To assess whether or not a task-based weight management programme [Weight Action Programme (WAP)] has better long-term effects than a 'best practice' intervention provided in primary care by practice nurses. Randomised controlled trial with cost-effectiveness analysis. General practices in east London, UK. Three hundred and thirty adults with a body mass index (BMI) of ≥ 30 kg/m 2 or a BMI of ≥ 28 kg/m 2 plus comorbidities were recruited from local general practices and via media publicity. Those who had a BMI of > 45 kg/m 2 , had lost > 5% of their body weight in the previous 6 months, were currently pregnant or taking psychiatric medications were excluded. Participants were randomised (2 : 1) to the WAP or nurse arms. The WAP intervention was delivered in eight weekly group sessions that combined dietary and physical activity, advice and self-monitoring in a group-oriented intervention. The initial course was followed by 10 monthly group maintenance sessions open to all participants in this study arm. The practice nurse intervention (best usual care) consisted of four one-to-one sessions delivered over 8 weeks, and included standard advice on diet and physical activity based on NHS 'Change4Life' materials and motivational support. The primary outcome measure was weight change at 12 months. Secondary outcome measures included change in BMI, waist circumference and blood pressure, and proportion of participants losing at least 5% and 10% of baseline body weight. Staff collecting measurements at the 6- and 12-month follow-ups were blinded to treatment allocation. The primary outcome measure was analysed according to the intention-to-treat principle

  2. Effects of women's groups practising participatory learning and action on preventive and care-seeking behaviours to reduce neonatal mortality: A meta-analysis of cluster-randomised trials.

    Directory of Open Access Journals (Sweden)

    Nadine Seward

    2017-12-01

    Full Text Available The World Health Organization recommends participatory learning and action (PLA in women's groups to improve maternal and newborn health, particularly in rural settings with low access to health services. There have been calls to understand the pathways through which this community intervention may affect neonatal mortality. We examined the effect of women's groups on key antenatal, delivery, and postnatal behaviours in order to understand pathways to mortality reduction.We conducted a meta-analysis using data from 7 cluster-randomised controlled trials that took place between 2001 and 2012 in rural India (2 trials, urban India (1 trial, rural Bangladesh (2 trials, rural Nepal (1 trial, and rural Malawi (1 trial, with the number of participants ranging between 6,125 and 29,901 live births. Behavioural outcomes included appropriate antenatal care, facility delivery, use of a safe delivery kit, hand washing by the birth attendant prior to delivery, use of a sterilised instrument to cut the umbilical cord, immediate wrapping of the newborn after delivery, delayed bathing of the newborn, early initiation of breastfeeding, and exclusive breastfeeding. We used 2-stage meta-analysis techniques to estimate the effect of the women's group intervention on behavioural outcomes. In the first stage, we used random effects models with individual patient data to assess the effect of groups on outcomes separately for the different trials. In the second stage of the meta-analysis, random effects models were applied using summary-level estimates calculated in the first stage of the analysis. To determine whether behaviour change was related to group attendance, we used random effects models to assess associations between outcomes and the following categories of group attendance and allocation: women attending a group and allocated to the intervention arm; women not attending a group but allocated to the intervention arm; and women allocated to the control arm

  3. COMPARISON OF THE INFLUENCE OF LONG-TERM TREATMENT BASED ON CARVEDILOL OR BISOPROLOL ON METABOLIC PARAMETERS IN HYPERTENSIVE PATIENTS WITH OVERWEIGHT OR OBESITY RESULTS OF THE RANDOMIZED OPEN-LABEL PARALLEL-GROUPS STEPPED TRIAL CABRIOLET (PART I

    Directory of Open Access Journals (Sweden)

    S. Y. Martsevich

    2012-01-01

    Full Text Available Aim. To compare antihypertensive and metabolic effects of long-term treatment with carvedilol or bisoprolol in patients with arterial hypertension (HT of 1-2 degree and overweight/obesity. Material and methods. A total of 105 patients were enrolled into open-label comparative stepped trial in two parallel groups. The patients were randomized into two groups: the group 1 (n=53 started treatment with carvedilol 25 mg daily and the group 2 (n=52 – with bisoprolol 5 mg daily. If the effect was insufficient a dose of a beta-blocker was doubled, then amlodipine was added in the dose of 5 mg daily with its further increase if necessary or indapamide in dose 1.5 mg daily. The follow-up for each patient was 24 weeks. At the start and then 12 and 24 weeks later the frequency of target blood pressure (BP achievement, body mass index, biochemical indices, ECG and treatment safety were evaluated. Results. Significant distinctions in antihypertensive therapy effect between the groups were absent (ΔBP=-29.5±11.3/17.8±8.4 and -30.4±12.8/18.7±8 mm Hg for groups 1 and 2, respectively , p<0.001 for the both groups as well as the necessity for additional therapy. All the patients completed the study had achieved target BP level. The patients of the both groups decreased body mass index after 6-month treatment (-0.57±1.1, p=0.001 and -0.53±0.8 kg/m2, p<0.001 for groups 1 and 2, respectively. Patients of the group 1 demonstrated significant reduction in fasting plasma glucose level (-0.45±1.2 mM/l, p=0.01, uric acid (-0.05±0.01 mM/l, p<0.001 and low-density lipoprotein cholesterol level (-0.28±0.9 mM/l, p<0.05 as well as a trend for HOMA index decrease. Serum creatinine level increased in patients of the group 2 (6.35±22.4 mcM/l, p=0.05 with no significant dynamics in metabolic indices. Glomerular filtration rate did not change significantly in the group 1, while there was significant decrease in the group 2 (Δ-3.8±15.2 ml/min/1,73m2, р=0.01. The

  4. COMPARISON OF THE INFLUENCE OF LONG-TERM TREATMENT BASED ON CARVEDILOL OR BISOPROLOL ON METABOLIC PARAMETERS IN HYPERTENSIVE PATIENTS WITH OVERWEIGHT OR OBESITY RESULTS OF THE RANDOMIZED OPEN-LABEL PARALLEL-GROUPS STEPPED TRIAL CABRIOLET (PART I

    Directory of Open Access Journals (Sweden)

    S. Y. Martsevich

    2015-12-01

    Full Text Available Aim. To compare antihypertensive and metabolic effects of long-term treatment with carvedilol or bisoprolol in patients with arterial hypertension (HT of 1-2 degree and overweight/obesity. Material and methods. A total of 105 patients were enrolled into open-label comparative stepped trial in two parallel groups. The patients were randomized into two groups: the group 1 (n=53 started treatment with carvedilol 25 mg daily and the group 2 (n=52 – with bisoprolol 5 mg daily. If the effect was insufficient a dose of a beta-blocker was doubled, then amlodipine was added in the dose of 5 mg daily with its further increase if necessary or indapamide in dose 1.5 mg daily. The follow-up for each patient was 24 weeks. At the start and then 12 and 24 weeks later the frequency of target blood pressure (BP achievement, body mass index, biochemical indices, ECG and treatment safety were evaluated. Results. Significant distinctions in antihypertensive therapy effect between the groups were absent (ΔBP=-29.5±11.3/17.8±8.4 and -30.4±12.8/18.7±8 mm Hg for groups 1 and 2, respectively , p<0.001 for the both groups as well as the necessity for additional therapy. All the patients completed the study had achieved target BP level. The patients of the both groups decreased body mass index after 6-month treatment (-0.57±1.1, p=0.001 and -0.53±0.8 kg/m2, p<0.001 for groups 1 and 2, respectively. Patients of the group 1 demonstrated significant reduction in fasting plasma glucose level (-0.45±1.2 mM/l, p=0.01, uric acid (-0.05±0.01 mM/l, p<0.001 and low-density lipoprotein cholesterol level (-0.28±0.9 mM/l, p<0.05 as well as a trend for HOMA index decrease. Serum creatinine level increased in patients of the group 2 (6.35±22.4 mcM/l, p=0.05 with no significant dynamics in metabolic indices. Glomerular filtration rate did not change significantly in the group 1, while there was significant decrease in the group 2 (Δ-3.8±15.2 ml/min/1,73m2, р=0.01. The

  5. A randomized, double-blind, multicenter, parallel group study to compare relative efficacies of the topical gels 3% erythromycin/5% benzoyl peroxide and 0.025% tretinoin/erythromycin 4% in the treatment of moderate acne vulgaris of the face.

    Science.gov (United States)

    Gupta, Aditya K; Lynde, Charles W; Kunynetz, Rod A W; Amin, Smita; Choi, Ken; Goldstein, Eric

    2003-01-01

    Combination treatments for acne vulgaris, such as Benzamycin (3% erythromycin/5% benzoyl peroxide) and Stievamycin (0.025% tretinoin/erythromycin 4%), reduce bacterial growth, which contributes to the inflammatory lesions typical of adolescent acne, and also decrease the epidermal cell compaction which may form the characteristic noninflammatory comedone. Both agents contain erythromycin to reduce the growth of Propionibacterium acnes in skin. Benzoyl peroxide has antibiotic activity as well as anticomedogenic properties. Tretinoin may increase the turnover of epidermal cells and loosen the cells compacted to form comedones. A combination preparation containing the two antibiotics may reduce the development of resistance; the combination preparation containing tretinoin and erythromycin will have an antibiotic effect as well as acting on differentiation. This multicenter, randomized, double-blind, parallel group study compared the effectiveness of 3% erythromycin/5% benzoyl peroxide and 0.025% tretinoin/erythromycin 4%, each applied twice daily in patients with moderate acne vulgaris. Overall physician and patient ratings of severity of acne symptoms were performed at baseline and at weeks 2, 4, 8, and 12. At baseline the two treatment groups had similar disease severity. The number of papules, pustules, and comedones was reduced in both treatment groups at week 12, and the reductions were not significantly different between the two comparators. Global physician rating of improvement was significantly higher in the 3% erythromycin/5% benzoyl peroxide group compared with the 0.025% tretinoin/erythromycin 4% group; however, there was no significant difference in global patient ratings between the two treatment groups. An aggregate score was produced, for both physician rating and patient rating, by adding up individual symptom severity ratings. Compared with 0.025% tretinoin/erythromycin 4%, 3% erythromycin/5% benzoyl peroxide provided significantly greater reduction

  6. Effects of an omega-3 fatty acid-enriched lipid emulsion on eicosanoid synthesis in acute respiratory distress syndrome (ARDS: A prospective, randomized, double-blind, parallel group study

    Directory of Open Access Journals (Sweden)

    Chacon Pilar

    2011-04-01

    Full Text Available Abstract Background The use of lipid emulsions has been associated with changes in lung function and gas exchange which may be mediated by biologically active metabolites derived from arachidonic acid. The type and quantity of the lipid emulsions used could modulate this response, which is mediated by the eicosanoids. This study investigates the use of omega-3 fatty acid-enriched lipid emulsions in ARDS patients and their effects on eicosanoid values. Methods Prospective, randomized, double-blind, parallel group study carried out at the Intensive Medicine Department of Vall d'Hebron University Hospital (Barcelona-Spain. We studied 16 consecutive patients with ARDS and intolerance to enteral nutrition (14 men; age: 58 ± 13 years; APACHE II score 17.8 ± 2.3; Lung Injury Score: 3.1 ± 0.5; baseline PaO2/FiO2 ratio: 149 ± 40. Patients were randomized into two groups: Group A (n = 8 received the study emulsion Lipoplus® 20%, B. Braun Medical (50% MCT, 40% LCT, 10% fish oil (FO; Group B (n = 8 received the control emulsion Intralipid® Fresenius Kabi (100% LCT. Lipid emulsions were administered for 12 h at a dose of 0.12 g/kg/h. We measured LTB4, TXB2, and 6-keto prostaglandin F1α values at baseline [immediately before the administration of the lipid emulsions (T-0], at the end of the administration (T-12 and 24 hours after the beginning of the infusion (T 24 in arterial and mixed venous blood samples. Results In group A (FO LTB4, TXB2, 6-keto prostaglandin F1α levels fell during omega-3 administration (T12. After discontinuation (T24, levels of inflammatory markers (both systemic and pulmonary behaved erratically. In group B (LCT all systemic and pulmonary mediators increased during lipid administration and returned to baseline levels after discontinuation, but the differences did not reach statistical significance. There was a clear interaction between the treatment in group A (fish oil and changes in LTB4 over time. Conclusions Infusion of

  7. Comparable long-term efficacy, as assessed by patient-reported outcomes, safety and pharmacokinetics, of CT-P13 and reference infliximab in patients with ankylosing spondylitis: 54-week results from the randomized, parallel-group PLANETAS study.

    Science.gov (United States)

    Park, Won; Yoo, Dae Hyun; Jaworski, Janusz; Brzezicki, Jan; Gnylorybov, Andriy; Kadinov, Vladimir; Sariego, Irmgadt Goecke; Abud-Mendoza, Carlos; Escalante, William Jose Otero; Kang, Seong Wook; Andersone, Daina; Blanco, Francisco; Hong, Seung Suh; Lee, Sun Hee; Braun, Jürgen

    2016-01-20

    CT-P13 (Remsima®, Inflectra®) is a biosimilar of the infliximab reference product (RP; Remicade®) and is approved in Europe and elsewhere, mostly for the same indications as RP. The aim of this study was to compare the 54-week efficacy, immunogenicity, pharmacokinetics (PK) and safety of CT-P13 with RP in patients with ankylosing spondylitis (AS), with a focus on patient-reported outcomes (PROs). This was a multinational, double-blind, parallel-group study in patients with active AS. Participants were randomized (1:1) to receive CT-P13 (5 mg/kg) or RP (5 mg/kg) at weeks 0, 2, 6 and then every 8 weeks up to week 54. To assess responses, standardized assessment tools were used with an intention-to-treat analysis of observed data. Anti-drug antibodies (ADAs), PK parameters, and safety outcomes were also assessed. Of 250 randomized patients (n = 125 per group), 210 (84.0 %) completed 54 weeks of treatment, with similar completion rates between groups. At week 54, Assessment of Spondylo Arthritis international Society (ASAS)20 response, ASAS40 response and ASAS partial remission were comparable between treatment groups. Changes from baseline in PROs such as mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI; CT-P13 -3.1 versus RP -2.8), Bath Ankylosing Spondylitis Functional Index (BASFI; -2.9 versus -2.7), and Short Form Health Survey (SF-36) scores (9.26 versus 10.13 for physical component summary; 7.30 versus 6.54 for mental component summary) were similar between treatment groups. At 54 weeks, 19.5 % and 23.0 % of patients receiving CT-P13 and RP, respectively, had ADAs. All observed PK parameters of CT-P13 and RP, including maximum and minimum serum concentrations, were similar through 54 weeks. The influence of ADAs on PK was similar in the two treatment groups. Most adverse events were mild or moderate in severity. There was no notable difference between treatment groups in the incidence of adverse events, serious adverse events

  8. Efficacy of Chlorhexidine, Xylitol, and Chlorhexidine + Xylitol against Dental Plaque, Gingivitis, and Salivary Streptococcus mutans Load: A Randomised Controlled Trial.

    Science.gov (United States)

    Marya, Charu Mohan; Taneja, Pratibha; Nagpal, Ruchi; Marya, Vandana; Oberoi, Sukhvinder Singh; Arora, Dimple

    To compare the antiplaque, antigingivitis and antibacterial efficacy of chlorhexidine (CHX), XYL and a mouthwash combining CHX and XYL against Streptococcus mutans (S. mutans). A parallel design, randomised controlled trial was conducted among 75 dental students. Participants were randomised into CHX, CHX+XYL and XYL-only groups using the lottery method. Subjects were instructed to use 10 ml of the provided mouthwash for 15 s twice daily for 3 weeks. All the outcome measures, gingival index (GI), plaque index (PI) and number of salivary S. mutans CFU were recorded at baseline and 3 weeks post intervention. Nonparametric tests were used for inferential statistics. All outcome variables (GI, PI scores and log10 salivary S. mutans counts) decreased significantly from baseline compared to post intervention among all three groups. Intergroup comparison demonstrated that reduction in GI was not significantly different among the three groups. The decrease in PI scores was found to be significantly higher in the XYL group, while the decrease in the log10 salivary S. mutans count was significantly higher in the CHX+XYL group. The present study provided sufficient data to suggest that all the three mouthwashes are effective against plaque, gingivitis and S. mutans load in saliva. Further investigations should be carried out to confirm the results and develop strategies for using such products to prevent tooth decay.

  9. Randomised social-skills training and parental training plus standard treatment versus standard treatment of children with attention deficit hyperactivity disorder - The SOSTRA trial protocol

    Directory of Open Access Journals (Sweden)

    Thomsen Per

    2011-01-01

    Full Text Available Abstract Background Children with attention deficit hyperactivity disorder (ADHD are hyperactive and impulsive, cannot maintain attention, and have difficulties with social interactions. Medical treatment may alleviate symptoms of ADHD, but seldom solves difficulties with social interactions. Social-skills training may benefit ADHD children in their social interactions. We want to examine the effects of social-skills training on difficulties related to the children's ADHD symptoms and social interactions. Methods/Design The design is randomised two-armed, parallel group, assessor-blinded trial. Children aged 8-12 years with a diagnosis of ADHD are randomised to social-skills training and parental training plus standard treatment versus standard treatment alone. A sample size calculation estimated that at least 52 children must be included to show a 4-point difference in the primary outcome on the Conners 3rd Edition subscale for 'hyperactivity-impulsivity' between the intervention group and the control group. The outcomes will be assessed 3 and 6 months after randomisation. The primary outcome measure is ADHD symptoms. The secondary outcome is social skills. Tertiary outcomes include the relationship between social skills and symptoms of ADHD, the ability to form attachment, and parents' ADHD symptoms. Discussion We hope that the results from this trial will show that the social-skills training together with medication may have a greater general effect on ADHD symptoms and social and emotional competencies than medication alone. Trial registration ClinicalTrials (NCT: NCT00937469

  10. 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...

  11. Rationale, Design, and Baseline Characteristics of the Utopia Trial for Preventing Diabetic Atherosclerosis Using an SGLT2 Inhibitor: A Prospective, Randomized, Open-Label, Parallel-Group Comparative Study.

    Science.gov (United States)

    Katakami, Naoto; Mita, Tomoya; Yoshii, Hidenori; Shiraiwa, Toshihiko; Yasuda, Tetsuyuki; Okada, Yosuke; Umayahara, Yutaka; Kaneto, Hideaki; Osonoi, Takeshi; Yamamoto, Tsunehiko; Kuribayashi, Nobuichi; Maeda, Kazuhisa; Yokoyama, Hiroki; Kosugi, Keisuke; Ohtoshi, Kentaro; Hayashi, Isao; Sumitani, Satoru; Tsugawa, Mamiko; Ohashi, Makoto; Taki, Hideki; Nakamura, Tadashi; Kawashima, Satoshi; Sato, Yasunori; Watada, Hirotaka; Shimomura, Iichiro

    2017-10-01

    Sodium-glucose co-transporter-2 (SGLT2) inhibitors are anti-diabetic agents that improve glycemic control with a low risk of hypoglycemia and ameliorate a variety of cardiovascular risk factors. The aim of the ongoing study described herein is to investigate the preventive effects of tofogliflozin, a potent and selective SGLT2 inhibitor, on the progression of atherosclerosis in subjects with type 2 diabetes (T2DM) using carotid intima-media thickness (IMT), an established marker of cardiovascular disease (CVD), as a marker. The Study of Using Tofogliflozin for Possible better Intervention against Atherosclerosis for type 2 diabetes patients (UTOPIA) trial is a prospective, randomized, open-label, blinded-endpoint, multicenter, and parallel-group comparative study. The aim was to recruit a total of 340 subjects with T2DM but no history of apparent CVD at 24 clinical sites and randomly allocate these to a tofogliflozin treatment group or a conventional treatment group using drugs other than SGLT2 inhibitors. As primary outcomes, changes in mean and maximum IMT of the common carotid artery during a 104-week treatment period will be measured by carotid echography. Secondary outcomes include changes in glycemic control, parameters related to β-cell function and diabetic nephropathy, the occurrence of CVD and adverse events, and biochemical measurements reflecting vascular function. This is the first study to address the effects of SGLT2 inhibitors on the progression of carotid IMT in subjects with T2DM without a history of CVD. The results will be available in the very near future, and these findings are expected to provide clinical data that will be helpful in the prevention of diabetic atherosclerosis and subsequent CVD. Kowa Co., Ltd. UMIN000017607.

  12. A double-blind, randomized, multiple-dose, parallel-group study to characterize the occurrence of diarrhea following two different dosing regimens of neratinib, an irreversible pan-ErbB receptor tyrosine kinase inhibitor.

    Science.gov (United States)

    Abbas, Richat; Hug, Bruce A; Leister, Cathie; Sonnichsen, Daryl

    2012-07-01

    Neratinib, a potent, low-molecular-weight, orally administered, irreversible, pan-ErbB receptor tyrosine kinase inhibitor has antitumor activity in ErbB2 + breast cancer. The objective of this study was to characterize the onset, severity, and duration of diarrhea after administration of neratinib 240 mg once daily (QD) and 120 mg twice daily (BID) for ≤14 days in healthy subjects. A randomized, double-blind, parallel-group, inpatient study was conducted in 50 subjects given oral neratinib either 240 mg QD or 120 mg BID with food for ≤14 days. The primary endpoint was the proportion of subjects with diarrhea of at least moderate severity (grade 2; 5-7 loose stools/day). In subjects with grade 2 diarrhea, fecal analytes were determined. Pharmacokinetic profiles were characterized for neratinib on Days 1 and 7. No severe (grade 3) diarrhea was reported. By Day 4, all subjects had grade 1 diarrhea. Grade 2 diarrhea occurred in 11/22 evaluable subjects (50 % [90 % confidence interval (CI): 28-72 %]) in the QD group and 17/23 evaluable subjects (74 % [90 % CI: 52-90 %]) in the BID group (P = 0.130). In fecal analyses, 18 % tested positive for hemoglobin and 46 % revealed fecal lactoferrin. Specimen pH was neutral to slightly alkaline. In pharmacokinetic analyses, Day 1 peak plasma concentration and Day 7 steady-state exposure were higher with the QD regimen than the BID regimen. In an exploratory analysis, ABCG2 genotype showed no correlation with severity or onset of diarrhea. Incidences and onsets of at least grade 1 and at least grade 2 diarrhea were not improved on BID dosing compared with QD dosing.

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

    Science.gov (United States)

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

    2004-05-01

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

  14. Parallel Atomistic Simulations

    Energy Technology Data Exchange (ETDEWEB)

    HEFFELFINGER,GRANT S.

    2000-01-18

    Algorithms developed to enable the use of atomistic molecular simulation methods with parallel computers are reviewed. Methods appropriate for bonded as well as non-bonded (and charged) interactions are included. While strategies for obtaining parallel molecular simulations have been developed for the full variety of atomistic simulation methods, molecular dynamics and Monte Carlo have received the most attention. Three main types of parallel molecular dynamics simulations have been developed, the replicated data decomposition, the spatial decomposition, and the force decomposition. For Monte Carlo simulations, parallel algorithms have been developed which can be divided into two categories, those which require a modified Markov chain and those which do not. Parallel algorithms developed for other simulation methods such as Gibbs ensemble Monte Carlo, grand canonical molecular dynamics, and Monte Carlo methods for protein structure determination are also reviewed and issues such as how to measure parallel efficiency, especially in the case of parallel Monte Carlo algorithms with modified Markov chains are discussed.

  15. Pressure ulcers prevention efficacy of an alternating pressure air mattress in elderly patients: E²MAO a randomised study.

    Science.gov (United States)

    Sauvage, P; Touflet, M; Pradere, C; Portalier, F; Michel, J-M; Charru, P; Passadori, Y; Fevrier, R; Hallet-Lezy, A-M; Beauchêne, F; Scherrer, B

    2017-06-02

    Our aim was to compare Axtair One, an alternating pressure air mattress (APAM), with a viscoelastic foam mattress (VFM) in elderly patients at moderate to high risk of developing pressure ulcers (PUs). A randomised, controlled, superiority, parallel-group, open-label, multicentre study, was conducted, between February 2012 and March 2015, in nine French, medium- and long-term stay facilities. Eligible patients were aged 70 and over, had no PUs on enrolment, were bedridden for at least 15 hours per day, had reduced mobility, an absent or minimal positioning capability, a Braden score 12 and a Karnofsky score elderly patients, bedridden for more than 15 hours per day, severely dependent, at moderate-to high-risk of PUs, with an instantaneous risk for the appearance of PUs 7.57 times greater in the VFM group than in the APAM group. This study provides descriptive information and evidence for practice.

  16. Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate

    DEFF Research Database (Denmark)

    Lohmander, Anette; Persson, Christina; Willadsen, Elisabeth

    2017-01-01

    BACKGROUND AND AIM: Adequate velopharyngeal function and speech are main goals in the treatment of cleft palate. The objective was to investigate if there were differences in velopharyngeal competency (VPC) and hypernasality at age 5 years in children with unilateral cleft lip and palate (UCLP...... cleft teams in five countries: Denmark, Finland, Sweden, Norway, and the UK. METHODS: Three different surgical protocols for primary palatal repair were tested against a common procedure in the total cohort of 448 children born with a non-syndromic UCLP. Speech audio and video recordings of 391 children......) operated on with different surgical methods for primary palatal repair. A secondary aim was to estimate burden of care in terms of received additional secondary surgeries and speech therapy. DESIGN: Three parallel group, randomised clinical trials were undertaken as an international multicentre study by 10...

  17. Acute Whiplash Injury Study (AWIS): a protocol for a cluster randomised pilot and feasibility trial of an Active Behavioural Physiotherapy Intervention in an insurance private setting

    Science.gov (United States)

    Wiangkham, Taweewat; Duda, Joan; Haque, M Sayeed; Price, Jonathan; Rushton, Alison

    2016-01-01

    Introduction Whiplash-associated disorder (WAD) causes substantial social and economic burden internationally. Up to 60% of patients with WAD progress to chronicity. Research therefore needs to focus on effective management in the acute stage to prevent the development of chronicity. Approximately 93% of patients are classified as WADII (neck complaint and musculoskeletal sign(s)), and in the UK, most are managed in the private sector. In our recent systematic review, a combination of active and behavioural physiotherapy was identified as potentially effective in the acute stage. An Active Behavioural Physiotherapy Intervention (ABPI) was developed through combining empirical (modified Delphi study) and theoretical (social cognitive theory focusing on self-efficacy) evidence. This pilot and feasibility trial has been designed to inform the design of an adequately powered definitive randomised controlled trial. Methods and analysis Two parallel phases. (1) An external pilot and feasibility cluster randomised double-blind (assessor and participants), parallel two-arm (ABPI vs standard physiotherapy) clinical trial to evaluate procedures and feasibility. Six UK private physiotherapy clinics will be recruited and cluster randomised by a computer-generated randomisation sequence. Sixty participants (30 each arm) will be assessed at recruitment (baseline) and at 3 months postbaseline. The planned primary outcome measure is the neck disability index. (2) An embedded exploratory qualitative study using semistructured indepth interviews (n=3–4 physiotherapists) and a focus group (n=6–8 patients) and entailing the recruitment of purposive samples will explore perceptions of the ABPI. Quantitative data will be analysed descriptively. Qualitative data will be coded and analysed deductively (identify themes) and inductively (identify additional themes). Ethics and dissemination This trial is approved by the University of Birmingham Ethics Committee (ERN_15-0542). Trial

  18. A 6-week, multicenter, randomized, double-masked, parallel-group study comparing travoprost 0.004% to latanoprost 0.005% followed by 6-week, open-label treatment with travoprost 0.004%.

    Science.gov (United States)

    Maul, Eugenio; Carrasco, Félix Gil; Costa, Vital Paulino; Casiraghi, Javier F; Vargas, Enrique; Sarmina, Judith S; Mayol, Renato

    2007-09-01

    The aim of this study was to compare the tolerability and efficacy of once-daily travoprost 0.004% versus latanoprost 0.005% for 6 weeks followed by 6 weeks of once-daily travoprost 0.004% in decreasing intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). This multicenter, randomized, doublemasked, active-controlled, parallel-group trial was conducted at 32 centers across Latin America. Patients aged > or =18 years with OAG or OH were randomly assigned to receive topical travoprost 0.004% or latanoprost 0.005% 1 drop QD (9 PM) for 6 weeks (masked phase). At 6 weeks, all patients were assigned to receive open-label travoprost 0.004% 1 drop QD (9 PM) for 6 additional weeks (open-label phase). Study visits were scheduled at weeks 1, 2, 4, 6, 8, and 12. At each study visit, IOP was measured at 5 PM (+/-1 hour; approximately 20 hours after study drug administration). IOP changes from baseline were combined (pooled) from the 1-, 2-, 4-, and 6-week data to provide a comparison between the 2 treatment groups. Ocular adverse events (AEs) were monitored using slit-lamp examination. A total of 302 patients were enrolled (travoprost group, 155 patients; latanoprost group, 147 patients). The mean (SD) age of the travoprost group was 61.9 (10.6) years; 60.6% were female; and 47.1% were white. The mean (SD) age of the latanoprost group was 60.5 (12.4) years; 62.6% were female; and 49.0% were white. Mean IOP values were not significantly different between the travoprost and latanoprost groups at baseline (24.7 vs 24.2 mm Hg) or 6 weeks; however, the between-group difference in reductions from baseline in pooled IOP during the masked phase of the study was statistically significant (-8.3 vs -7.5 mm Hg; P = 0.009). At weeks 6 and 12, mean lOP levels were 16.1 and 16.2 mm Hg, respectively, in the travoprost group and 16.4 and 16.1 mm Hg in the group that was switched from latanoprost to travoprost (all, P = NS). The most common ocular AEs

  19. The effect of souvenaid on functional brain network organisation in patients with mild Alzheimer's disease: a randomised controlled study.

    Directory of Open Access Journals (Sweden)

    Hanneke de Waal

    Full Text Available Synaptic loss is a major hallmark of Alzheimer's disease (AD. Disturbed organisation of large-scale functional brain networks in AD might reflect synaptic loss and disrupted neuronal communication. The medical food Souvenaid, containing the specific nutrient combination Fortasyn Connect, is designed to enhance synapse formation and function and has been shown to improve memory performance in patients with mild AD in two randomised controlled trials.To explore the effect of Souvenaid compared to control product on brain activity-based networks, as a derivative of underlying synaptic function, in patients with mild AD.A 24-week randomised, controlled, double-blind, parallel-group, multi-country study.179 drug-naïve mild AD patients who participated in the Souvenir II study.Patients were randomised 1∶1 to receive Souvenaid or an iso-caloric control product once daily for 24 weeks.In a secondary analysis of the Souvenir II study, electroencephalography (EEG brain networks were constructed and graph theory was used to quantify complex brain structure. Local brain network connectivity (normalised clustering coefficient gamma and global network integration (normalised characteristic path length lambda were compared between study groups, and related to memory performance.THE NETWORK MEASURES IN THE BETA BAND WERE SIGNIFICANTLY DIFFERENT BETWEEN GROUPS: they decreased in the control group, but remained relatively unchanged in the active group. No consistent relationship was found between these network measures and memory performance.The current results suggest that Souvenaid preserves the organisation of brain networks in patients with mild AD within 24 weeks, hypothetically counteracting the progressive network disruption over time in AD. The results strengthen the hypothesis that Souvenaid affects synaptic integrity and function. Secondly, we conclude that advanced EEG analysis, using the mathematical framework of graph theory, is useful and

  20. The effect of souvenaid on functional brain network organisation in patients with mild Alzheimer's disease: a randomised controlled study.

    Science.gov (United States)

    de Waal, Hanneke; Stam, Cornelis J; Lansbergen, Marieke M; Wieggers, Rico L; Kamphuis, Patrick J G H; Scheltens, Philip; Maestú, Fernando; van Straaten, Elisabeth C W

    2014-01-01

    Synaptic loss is a major hallmark of Alzheimer's disease (AD). Disturbed organisation of large-scale functional brain networks in AD might reflect synaptic loss and disrupted neuronal communication. The medical food Souvenaid, containing the specific nutrient combination Fortasyn Connect, is designed to enhance synapse formation and function and has been shown to improve memory performance in patients with mild AD in two randomised controlled trials. To explore the effect of Souvenaid compared to control product on brain activity-based networks, as a derivative of underlying synaptic function, in patients with mild AD. A 24-week randomised, controlled, double-blind, parallel-group, multi-country study. 179 drug-naïve mild AD patients who participated in the Souvenir II study. Patients were randomised 1∶1 to receive Souvenaid or an iso-caloric control product once daily for 24 weeks. In a secondary analysis of the Souvenir II study, electroencephalography (EEG) brain networks were constructed and graph theory was used to quantify complex brain structure. Local brain network connectivity (normalised clustering coefficient gamma) and global network integration (normalised characteristic path length lambda) were compared between study groups, and related to memory performance. THE NETWORK MEASURES IN THE BETA BAND WERE SIGNIFICANTLY DIFFERENT BETWEEN GROUPS: they decreased in the control group, but remained relatively unchanged in the active group. No consistent relationship was found between these network measures and memory performance. The current results suggest that Souvenaid preserves the organisation of brain networks in patients with mild AD within 24 weeks, hypothetically counteracting the progressive network disruption over time in AD. The results strengthen the hypothesis that Souvenaid affects synaptic integrity and function. Secondly, we conclude that advanced EEG analysis, using the mathematical framework of graph theory, is useful and feasible for

  1. Self-managed loaded exercise versus usual physiotherapy treatment for rotator cuff tendinopathy: a pilot randomised controlled trial.

    Science.gov (United States)

    Littlewood, Chris; Malliaras, Peter; Mawson, Sue; May, Stephen; Walters, Stephen J

    2014-03-01

    Rotator cuff tendinopathy is a common source of shoulder pain characterised by persistent and/or recurrent problems for a proportion of sufferers. The aim of this study was to pilot the methods proposed to conduct a substantive study to evaluate the effectiveness of a self-managed loaded exercise programme versus usual physiotherapy treatment for rotator cuff tendinopathy. A single-centre pragmatic unblinded parallel group pilot randomised controlled trial. One private physiotherapy clinic, northern England. Twenty-four participants with rotator cuff tendinopathy. The intervention was a programme of self-managed loaded exercise. The control group received usual physiotherapy treatment. Baseline assessment comprised the Shoulder Pain and Disability Index (SPADI) and the Short-Form 36, repeated three months post randomisation. The recruitment target was met and the majority of participants (98%) were willing to be randomised. 100% retention was attained with all participants completing the SPADI at three months. Exercise adherence rates were excellent (90%). The mean change in SPADI score was -23.7 (95% CI -14.4 to -33.3) points for the self-managed exercise group and -19.0 (95% CI -6.0 to -31.9) points for the usual physiotherapy treatment group. The difference in three month SPADI scores was 0.1 (95% CI -16.6 to 16.9) points in favour of the usual physiotherapy treatment group. In keeping with previous research which indicates the need for further evaluation of self-managed loaded exercise for rotator cuff tendinopathy, these methods and the preliminary evaluation of outcome offer a foundation and stimulus to conduct a substantive study. Copyright © 2013 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

  2. 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.

  3. SaFaRI: sacral nerve stimulation versus the FENIX magnetic sphincter augmentation for adult faecal incontinence: a randomised investigation.

    Science.gov (United States)

    Williams, Annabelle E; Croft, Julie; Napp, Vicky; Corrigan, Neil; Brown, Julia M; Hulme, Claire; Brown, Steven R; Lodge, Jen; Protheroe, David; Jayne, David G

    2016-02-01

    Faecal incontinence is a physically, psychologically and socially disabling condition. NICE guidance (2007) recommends surgical intervention, including sacral nerve stimulation (SNS), after failed conservative therapies. The FENIX magnetic sphincter augmentation (MSA) device is a novel continence device consisting of a flexible band of interlinked titanium beads with magnetic cores that is placed around the anal canal to augment anal sphincter tone through passive attraction of the beads. Preliminary studies suggest the FENIX MSA is safe, but efficacy data is limited. Rigorous evaluation is required prior to widespread adoption. The SaFaRI trial is a National Institute of Health Research (NIHR) Health Technology Assessment (HTA)-funded UK multi-site, parallel group, randomised controlled, unblinded trial that will investigate the use of the FENIX MSA, as compared to SNS, for adult faecal incontinence resistant to conservative management. Twenty sites across the UK, experienced in the treatment of faecal incontinence, will recruit 350 patients randomised equally to receive either SNS or FENIX MSA. Participants will be followed-up at 2 weeks post-surgery and at 6, 12 and 18 months post-randomisation. The primary endpoint is success, as defined by device in use and ≥50 % improvement in the Cleveland Clinic Incontinence Score (CCIS) at 18 months post-randomisation. Secondary endpoints include complications, quality of life and cost effectiveness. SaFaRI will rigorously evaluate a new technology for faecal incontinence, the FENIX™ MSA, allowing its safe and controlled introduction into current clinical practice. These results will inform the future surgical management of adult faecal incontinence.

  4. iCanADAPT Early protocol: randomised controlled trial (RCT) of clinician supervised transdiagnostic internet-delivered cognitive behaviour therapy (iCBT) for depression and/or anxiety in early stage cancer survivors -vs- treatment as usual

    OpenAIRE

    Murphy, M. J.; Newby, J. M.; Butow, P.; Kirsten, L.; Allison, K.; Loughnan, S.; Price, M. A.; Shaw, J.; Shepherd, H.; Smith, J.; Andrews, G.

    2017-01-01

    Background This RCT with two parallel arms will evaluate the efficacy of an internet-delivered transdiagnostic cognitive behavioural therapy (iCBT) intervention for the treatment of clinical depression and/or anxiety in early stage cancer survivors. Methods/design Early stage cancer survivors will be recruited via the research arm of a not-for-profit clinical research unit and randomised to an intervention (iCBT) group or a ?treatment as usual? (TAU) control group. The minimum sample size for...

  5. Broadcasting a message in a parallel computer

    Science.gov (United States)

    Berg, Jeremy E [Rochester, MN; Faraj, Ahmad A [Rochester, MN

    2011-08-02

    Methods, systems, and products are disclosed for broadcasting a message in a parallel computer. The parallel computer includes a plurality of compute nodes connected together using a data communications network. The data communications network optimized for point to point data communications and is characterized by at least two dimensions. The compute nodes are organized into at least one operational group of compute nodes for collective parallel operations of the parallel computer. One compute node of the operational group assigned to be a logical root. Broadcasting a message in a parallel computer includes: establishing a Hamiltonian path along all of the compute nodes in at least one plane of the data communications network and in the operational group; and broadcasting, by the logical root to the remaining compute nodes, the logical root's message along the established Hamiltonian path.

  6. A Novel Highly Bioavailable Curcumin Formulation Improves Symptoms and Diagnostic Indicators in Rheumatoid Arthritis Patients: A Randomized, Double-Blind, Placebo-Controlled, Two-Dose, Three-Arm, and Parallel-Group Study.

    Science.gov (United States)

    Amalraj, Augustine; Varma, Karthik; Jacob, Joby; Divya, Chandradhara; Kunnumakkara, Ajaikumar B; Stohs, Sidney J; Gopi, Sreeraj

    2017-10-01

    Rheumatoid arthritis (RA) is an autoimmune, chronic systemic inflammatory disorder. The long-term use of currently available drugs for the treatment of RA has many potential side effects. Natural phytonutrients may serve as alternative strategies for the safe and effective treatment of RA, and curcuminoids have been used in Ayurvedic medicine for the treatment of inflammatory conditions for centuries. In this study, a novel, highly bioavailable form of curcumin in a completely natural turmeric matrix was evaluated for its ability to improve the clinical symptoms of RA. A randomized, double-blind, placebo-controlled, three-arm, parallel-group study was conducted to evaluate the comparative efficacy of two different doses of curcumin with that of a placebo in active RA patients. Twelve patients in each group received placebo, 250 or 500 mg of the curcumin product twice daily for 90 days. The responses of the patients were assessed using the American College of Rheumatology (ACR) response, visual analog scale (VAS), C-reactive protein (CRP), Disease Activity Score 28 (DAS28), erythrocyte sedimentation rate (ESR), and rheumatoid factor (RF) values. RA patients who received the curcumin product at both low and high doses reported statistically significant changes in their clinical symptoms at the end of the study. These observations were confirmed by significant changes in ESR, CPR, and RF values in patients receiving the study product compared to baseline and placebo. The results indicate that this novel curcumin in a turmeric matrix acts as an analgesic and anti-inflammatory agent for the management of RA at a dose as low as 250 mg twice daily as evidenced by significant improvement in the ESR, CRP, VAS, RF, DAS28, and ACR responses compared to placebo. Both doses of the study product were well tolerated and without side effects.

  7. A phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of etelcalcetide (ONO-5163/AMG 416), a novel intravenous calcimimetic, for secondary hyperparathyroidism in Japanese haemodialysis patients.

    Science.gov (United States)

    Fukagawa, Masafumi; Yokoyama, Keitaro; Shigematsu, Takashi; Akiba, Takashi; Fujii, Akifumi; Kuramoto, Takuto; Odani, Motoi; Akizawa, Tadao

    2017-10-01

    Secondary hyperparathyroidism (SHPT) is a major complication associated with chronic kidney disease. We evaluated the efficacy and safety of etelcalcetide (ONO-5163/AMG 416), a novel intravenous calcimimetic, in Japanese haemodialysis patients with SHPT. In this phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel-group study, etelcalcetide was administered three times per week at an initial dose of 5 mg, and subsequently adjusted to doses between 2.5 and 15 mg at 4-week intervals for 12 weeks. A total of 155 SHPT patients with serum intact parathyroid hormone (iPTH) levels ≥300 pg/mL were assigned to receive etelcalcetide (n = 78) or placebo (n = 77). The primary endpoint was the proportion of patients with decreased serum iPTH to the target range proposed by the Japanese Society for Dialysis Therapy (60-240 pg/mL). The major secondary endpoint was the proportion of patients with ≥30% reductions in serum iPTH from baseline. The proportion of patients meeting the primary endpoint was significantly higher for etelcalcetide (59.0%) versus placebo (1.3%). Similarly, the proportion of patients meeting the major secondary endpoint was significantly higher for etelcalcetide (76.9%) versus placebo (5.2%). Serum albumin-corrected calcium, phosphorus and intact fibroblast growth factor-23 levels were decreased in the etelcalcetide group. Nausea, vomiting and symptomatic hypocalcaemia were mild with etelcalcetide. Serious adverse events related to etelcalcetide were not observed. This study demonstrated the efficacy and safety of etelcalcetide. As the only available intravenous calcium-sensing receptor agonist, etelcalcetide is likely to provide a new treatment option for SHPT in haemodialysis patients. © The Author 2017. Published by Oxford University Press on behalf of ERA-EDTA.

  8. Effects of oral contraceptives containing ethinylestradiol with either drospirenone or levonorgestrel on various parameters associated with well-being in healthy women: a randomized, single-blind, parallel-group, multicentre study.

    Science.gov (United States)

    Kelly, Sue; Davies, Emyr; Fearns, Simon; McKinnon, Carol; Carter, Rick; Gerlinger, Christoph; Smithers, Andrew

    2010-01-01

    The combined oral contraceptive Yasmin (drospirenone 3 mg plus ethinylestradiol 30 microg [DRSP 3 mg/EE 30 microg]) has been shown to be a well tolerated and effective combination that provides high contraceptive reliability and good cycle control. Furthermore, DRSP 3 mg/EE 30 microg has been shown to have a positive effect on premenstrual symptoms and well-being/health-related quality of life, and to improve the skin condition of women with acne. To date, however, there have been relatively few studies that have compared the effects of DRSP 3 mg/EE 30 microg on the general well-being of women with those of other oral contraceptives. To compare the impact of DRSP 3 mg/EE 30 microg with that of levonorgestrel 150 microg/EE 30 microg (LNG 150 microg/EE 30 microg; Microgynon 30) on various parameters associated with well-being in healthy female subjects. This was a randomized, single-blind, parallel-group, multicentre study conducted using 21/7-day regimens of DRSP 3 mg/EE 30 microg and LNG 150 microg/EE 30 microg over seven cycles. Efficacy parameters included: changes in Menstrual Distress Questionnaire (MDQ) normative T scores; the proportion of subjects with acne; and menstrual symptoms. Cycle control and subjective well-being parameters were also assessed. Treatment with DRSP 3 mg/EE 30 microg had similar beneficial effects on symptoms of water retention and impaired concentration to LNG 150 microg/EE 30 microg, but was significantly better in alleviating negative affect symptoms during the menstrual phase (median difference in MDQ T score -3; p = 0.027; Wilcoxon rank sum test). The proportion of subjects with acne decreased from approximately 55% to approximately 45% in the DRSP 3 mg/EE 30 microg group, but remained static at approximately 60% in the LNG 150 microg/EE 30 microg group. Somatic and psychological symptoms occurred at the greatest intensity and for most subjects during the menstrual phase of the cycle in both groups. Both drugs had similar cycle

  9. 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

  10. 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

  11. 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

  12. Phase 1, randomized, parallel-group, double-blind, placebo-controlled trial to evaluate the effects of erenumab (AMG 334) and concomitant sumatriptan on blood pressure in healthy volunteers.

    Science.gov (United States)

    de Hoon, Jan; Van Hecken, Anne; Vandermeulen, Corinne; Herbots, Marissa; Kubo, Yumi; Lee, Ed; Eisele, Osa; Vargas, Gabriel; Gabriel, Kristin

    2018-01-01

    Objectives The aim of this study was to assess the effects of concomitant administration of erenumab and sumatriptan on resting blood pressure, pharmacokinetics, safety, and tolerability in healthy subjects. Methods In this phase 1, parallel-group, one-way crossover, double-blind, placebo-controlled study, healthy adult subjects were randomized (1:2) to receive either intravenous placebo and subcutaneous sumatriptan 12 mg (i.e. two 6-mg injections separated by 1 hour) or intravenous erenumab 140 mg and subcutaneous sumatriptan 12 mg. Blood pressure was measured pre-dose and at prespecified times post-dose. The primary endpoint was individual time-weighted averages of mean arterial pressure, measured from 0 hours to 2.5 hours after the first dose of sumatriptan. Pharmacokinetic parameters for sumatriptan were evaluated by calculating geometric mean ratios (erenumab and sumatriptan/placebo and sumatriptan). Adverse events and anti-erenumab antibodies were also evaluated. Results A total of 34 subjects were randomized and included in the analysis. Least squares mean (standard error) time-weighted averages of mean arterial pressure were 87.4 (1.0) mmHg for the placebo and sumatriptan group and 87.4 (1.2) mmHg for the erenumab and sumatriptan group. Mean difference in mean arterial pressure between groups was -0.04 mmHg (90% confidence interval: -2.2, 2.1). Geometric mean ratio estimates for maximum plasma concentration of sumatriptan was 0.95 (90% confidence interval: 0.82, 1.09), area under the plasma concentration-time curve (AUC) from time 0 to 6 hours was 0.98 (90% confidence interval: 0.93, 1.03), and AUC from time 0 to infinity was 1.00 (90% confidence interval: 0.96, 1.05). No clinically relevant safety findings for co-administration of sumatriptan and erenumab were identified. Conclusion Co-administration of erenumab and sumatriptan had no additional effect on resting blood pressure or on pharmacokinetics of sumatriptan. ClinicalTrials.gov, NCT

  13. Parallelization in Modern C++

    CERN Multimedia

    CERN. Geneva

    2016-01-01

    The traditionally used and well established parallel programming models OpenMP and MPI are both targeting lower level parallelism and are meant to be as language agnostic as possible. For a long time, those models were the only widely available portable options for developing parallel C++ applications beyond using plain threads. This has strongly limited the optimization capabilities of compilers, has inhibited extensibility and genericity, and has restricted the use of those models together with other, modern higher level abstractions introduced by the C++11 and C++14 standards. The recent revival of interest in the industry and wider community for the C++ language has also spurred a remarkable amount of standardization proposals and technical specifications being developed. Those efforts however have so far failed to build a vision on how to seamlessly integrate various types of parallelism, such as iterative parallel execution, task-based parallelism, asynchronous many-task execution flows, continuation s...

  14. Parallelism in matrix computations

    CERN Document Server

    Gallopoulos, Efstratios; Sameh, Ahmed H

    2016-01-01

    This book is primarily intended as a research monograph that could also be used in graduate courses for the design of parallel algorithms in matrix computations. It assumes general but not extensive knowledge of numerical linear algebra, parallel architectures, and parallel programming paradigms. The book consists of four parts: (I) Basics; (II) Dense and Special Matrix Computations; (III) Sparse Matrix Computations; and (IV) Matrix functions and characteristics. Part I deals with parallel programming paradigms and fundamental kernels, including reordering schemes for sparse matrices. Part II is devoted to dense matrix computations such as parallel algorithms for solving linear systems, linear least squares, the symmetric algebraic eigenvalue problem, and the singular-value decomposition. It also deals with the development of parallel algorithms for special linear systems such as banded ,Vandermonde ,Toeplitz ,and block Toeplitz systems. Part III addresses sparse matrix computations: (a) the development of pa...

  15. Effectiveness of a healthy lifestyle intervention for low back pain and osteoarthritis of the knee: protocol and statistical analysis plan for two randomised controlled trials

    Directory of Open Access Journals (Sweden)

    Kate M. O’Brien

    Full Text Available ABSTRACT Background These trials are the first randomised controlled trials of telephone-based weight management and healthy lifestyle interventions for low back pain and knee osteoarthritis. This article describes the protocol and statistical analysis plan. Method These trials are parallel randomised controlled trials that investigate and compare the effect of a telephone-based weight management and healthy lifestyle intervention for improving pain intensity in overweight or obese patients with low back pain or knee osteoarthritis. The analysis plan was finalised prior to initiation of analyses. All data collected as part of the trial were reviewed, without stratification by group, and classified by baseline characteristics, process of care and trial outcomes. Trial outcomes were classified as primary and secondary outcomes. Appropriate descriptive statistics and statistical testing of between-group differences, where relevant, have been planned and described. Conclusions A protocol for standard analyses was developed for the results of two randomised controlled trials. This protocol describes the data, and the pre-determined statistical tests of relevant outcome measures. The plan demonstrates transparent and verifiable use of the data collected. This a priori protocol will be followed to ensure rigorous standards of data analysis are strictly adhered to.

  16. Effectiveness of a healthy lifestyle intervention for low back pain and osteoarthritis of the knee: protocol and statistical analysis plan for two randomised controlled trials

    Science.gov (United States)

    O’Brien, Kate M.; Williams, Amanda; Wiggers, John; Wolfenden, Luke; Yoong, Serene; Campbell, Elizabeth; Kamper, Steven J.; McAuley, James; Attia, John; Oldmeadow, Chris; Williams, Christopher M.

    2016-01-01

    ABSTRACT Background These trials are the first randomised controlled trials of telephone-based weight management and healthy lifestyle interventions for low back pain and knee osteoarthritis. This article describes the protocol and statistical analysis plan. Method These trials are parallel randomised controlled trials that investigate and compare the effect of a telephone-based weight management and healthy lifestyle intervention for improving pain intensity in overweight or obese patients with low back pain or knee osteoarthritis. The analysis plan was finalised prior to initiation of analyses. All data collected as part of the trial were reviewed, without stratification by group, and classified by baseline characteristics, process of care and trial outcomes. Trial outcomes were classified as primary and secondary outcomes. Appropriate descriptive statistics and statistical testing of between-group differences, where relevant, have been planned and described. Conclusions A protocol for standard analyses was developed for the results of two randomised controlled trials. This protocol describes the data, and the pre-determined statistical tests of relevant outcome measures. The plan demonstrates transparent and verifiable use of the data collected. This a priori protocol will be followed to ensure rigorous standards of data analysis are strictly adhered to. PMID:27683839

  17. The serious mental illness health improvement profile [HIP]: study protocol for a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Swift Louise

    2011-07-01

    Full Text Available Abstract Background The serious mental illness Health Improvement Profile [HIP] is a brief pragmatic tool, which enables mental health nurses to work together with patients to screen physical health and take evidence-based action when variables are identified to be at risk. Piloting has demonstrated clinical utility and acceptability. Methods/Design A single blind parallel group cluster randomised controlled trial with secondary economic analysis and process observation. Unit of randomisation: mental health nurses [MHNs] working in adult community mental health teams across two NHS Trusts. Subjects: Patients over 18 years with a diagnosis of schizophrenia, schizoaffective or bipolar disorder on the caseload of participating MHNs. Primary objective: To determine the effects of the HIP programme on patients' physical wellbeing assessed by the physical component score of the Medical Outcome Study (MOS 36 Item Short Form Health Survey version 2 [SF-36v2]. Secondary objectives: To determine the effects of the HIP programme on: cost effectiveness, mental wellbeing, cardiovascular risk, physical health care attitudes and knowledge of MHNs and to determine the acceptability of the HIP Programme in the NHS. Consented nurses (and patients will be randomised to receive the HIP Programme or treatment as usual. Outcomes will be measured at baseline and 12 months with a process observation after 12 months to include evaluation of patients' and professionals' experience and observation of any effect on care plans and primary-secondary care interface communication. Outcomes will be analysed on an intention-to-treat (ITT basis. Discussion The results of the trial and process observation will provide information about the effectiveness of the HIP Programme in supporting MHNs to address physical comorbidity in serious mental illness. Given the current unacceptable prevalence of physical comorbidity and mortality in the serious mental illness population, it is

  18. A prospective, parallel group, open-labeled, comparative, multi-centric, active controlled study to evaluate the safety, tolerability and benefits of fixed dose combination of acarbose and metformin versus metformin alone in type 2 diabetes.

    Science.gov (United States)

    Jayaram, S; Hariharan, R S; Madhavan, R; Periyandavar, I; Samra, S S

    2010-11-01

    The present study was a prospective, parallel group, open-labeled, comparative, multicentric, active controlled study to evaluate the safety, tolerability and benefits of fixed dose combination of acarbose and metformin versus metformin alone in type 2 diabetic patients. A total of 229 patients with type 2 diabetes were enrolled at 5 medical centers across India. They received either acarbose (50 mg) + metformin (500 mg) bid/tid (n=115) or metformin monotherapy (500 mg) bid/ tid (n=114) for 12 weeks. Primary objective was to evaluate safety and tolerability based on the adverse events reported. Secondary objective was efficacy assessment based on changes in fasting, post prandial blood glucose and HbA1c values. In the acarbose + metformin group 10 patients reported 14 adverse events while in metformin group 9 patients reported 10 adverse events. No patient reported any serious adverse event or was withdraw from study because of adverse events. In the acarbose plus metformin group fasting blood glucose (FBG) decreased from a baseline of 158.85 +/- 18.14 mg/dl to 113.55 +/- 19.38 mg/dl (p fasting blood glucose decreased from a baseline of 158.31 +/- 26.53 mg/dl to 130.55 +/- 28.31 mg/dl (p < 0.0001) (decrease of 27.76 +/- 22.91 mg/dl) at 12 weeks. In the acarbose plus metformin group postprandial blood glucose (PPBG) decreased from a baseline of 264.65 +/- 34.03 mg/dl to 173.22 +/- 31.40 mg/dl (p < 0.0001) (decrease of 91.43 +/- 28.65 mg/dl) at 12 weeks, while in the metformin group PPBG decreased from a baseline of 253.56 +/- 36.28 mg/dl to 205.36 +/- 39.49 mg/dl (p < 0.0001) (decrease of 48.20 +/- 32.72 mg/dl) at 12 weeks. In the acarbose plus metformin group glycosylated haemoglobin (HbA1c) decreased from a baseline of 9.47 +/- 0.69% to 7.71 +/- 0.85% (p < 0.0001) (% decrease of 1.76 +/- 1.11) at 12 weeks, while in the metformin group HbAlc decreased from a baseline of 9.32 +/- 0.65% to 8.26 +/- 0.68% (p < 0.0001) (% decrease of 1.06 +/- 0.66) at 12 weeks. The

  19. Treatment strategies in colorectal cancer patients with initially unresectable liver-only metastases, a study protocol of the randomised phase 3 CAIRO5 study of the Dutch Colorectal Cancer Group (DCCG)

    International Nuclear Information System (INIS)

    Huiskens, Joost; Gulik, Thomas M van; Lienden, Krijn P van; Engelbrecht, Marc RW; Meijer, Gerrit A; Grieken, Nicole CT van; Schriek, Jonne; Keijser, Astrid; Mol, Linda; Molenaar, I Quintus; Verhoef, Cornelis; Jong, Koert P de; Dejong, Kees HC; Kazemier, Geert; Ruers, Theo M; Wilt, Johanus HW de; Tinteren, Harm van; Punt, Cornelis JA

    2015-01-01

    Colorectal cancer patients with unresectable liver-only metastases may be cured after downsizing of metastases by neoadjuvant systemic therapy. However, the optimal neoadjuvant induction regimen has not been defined, and the lack of consensus on criteria for (un)resectability complicates the interpretation of published results. CAIRO5 is a multicentre, randomised, phase 3 clinical study. Colorectal cancer patients with initially unresectable liver-only metastases are eligible, and will not be selected for potential resectability. The (un)resectability status is prospectively assessed by a central panel consisting of at least one radiologist and three liver surgeons, according to predefined criteria. Tumours of included patients will be tested for RAS mutation status. Patients with RAS wild type tumours will be treated with doublet chemotherapy (FOLFOX or FOLFIRI) and randomised between the addition of either bevacizumab or panitumumab, and patients with RAS mutant tumours will be randomised between doublet chemotherapy (FOLFOX or FOLFIRI) plus bevacizumab or triple chemotherapy (FOLFOXIRI) plus bevacizumab. Radiological evaluation to assess conversion to resectability will be performed by the central panel, at an interval of two months. The primary study endpoint is median progression-free survival. Secondary endpoints are the R0/1 resection rate, median overall survival, response rate, toxicity, pathological response of resected lesions, postoperative morbidity, and correlation of baseline and follow-up evaluation with respect to outcomes by the central panel. CAIRO5 is a prospective multicentre trial that investigates the optimal systemic induction therapy for patients with initially unresectable, liver-only colorectal cancer metastases. CAIRO 5 is registered at European Clinical Trials Database (EudraCT) (2013-005435-24). CAIRO 5 is registered at ClinicalTrials.gov: NCT02162563, June 10, 2014

  20. A parallel buffer tree

    DEFF Research Database (Denmark)

    Sitchinava, Nodar; Zeh, Norbert

    2012-01-01

    We present the parallel buffer tree, a parallel external memory (PEM) data structure for batched search problems. This data structure is a non-trivial extension of Arge's sequential buffer tree to a private-cache multiprocessor environment and reduces the number of I/O operations by the number of...... in the optimal OhOf(psortN + K/PB) parallel I/O complexity, where K is the size of the output reported in the process and psortN is the parallel I/O complexity of sorting N elements using P processors....

  1. Parallel MR imaging.

    Science.gov (United States)

    Deshmane, Anagha; Gulani, Vikas; Griswold, Mark A; Seiberlich, Nicole

    2012-07-01

    Parallel imaging is a robust method for accelerating the acquisition of magnetic resonance imaging (MRI) data, and has made possible many new applications of MR imaging. Parallel imaging works by acquiring a reduced amount of k-space data with an array of receiver coils. These undersampled data can be acquired more quickly, but the undersampling leads to aliased images. One of several parallel imaging algorithms can then be used to reconstruct artifact-free images from either the aliased images (SENSE-type reconstruction) or from the undersampled data (GRAPPA-type reconstruction). The advantages of parallel imaging in a clinical setting include faster image acquisition, which can be used, for instance, to shorten breath-hold times resulting in fewer motion-corrupted examinations. In this article the basic concepts behind parallel imaging are introduced. The relationship between undersampling and aliasing is discussed and two commonly used parallel imaging methods, SENSE and GRAPPA, are explained in detail. Examples of artifacts arising from parallel imaging are shown and ways to detect and mitigate these artifacts are described. Finally, several current applications of parallel imaging are presented and recent advancements and promising research in parallel imaging are briefly reviewed. Copyright © 2012 Wiley Periodicals, Inc.

  2. Parallel Algorithms and Patterns

    Energy Technology Data Exchange (ETDEWEB)

    Robey, Robert W. [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2016-06-16

    This is a powerpoint presentation on parallel algorithms and patterns. A parallel algorithm is a well-defined, step-by-step computational procedure that emphasizes concurrency to solve a problem. Examples of problems include: Sorting, searching, optimization, matrix operations. A parallel pattern is a computational step in a sequence of independent, potentially concurrent operations that occurs in diverse scenarios with some frequency. Examples are: Reductions, prefix scans, ghost cell updates. We only touch on parallel patterns in this presentation. It really deserves its own detailed discussion which Gabe Rockefeller would like to develop.

  3. Application Portable Parallel Library

    Science.gov (United States)

    Cole, Gary L.; Blech, Richard A.; Quealy, Angela; Townsend, Scott

    1995-01-01

    Application Portable Parallel Library (APPL) computer program is subroutine-based message-passing software library intended to provide consistent interface to variety of multiprocessor computers on market today. Minimizes effort needed to move application program from one computer to another. User develops application program once and then easily moves application program from parallel computer on which created to another parallel computer. ("Parallel computer" also include heterogeneous collection of networked computers). Written in C language with one FORTRAN 77 subroutine for UNIX-based computers and callable from application programs written in C language or FORTRAN 77.

  4. Efficacy and safety of renal denervation for Chinese patients with resistant hypertension using a microirrigated catheter: study design and protocol for a prospective multicentre randomised controlled trial.

    Science.gov (United States)

    Liu, Zongjun; Shen, Li; Huang, Weijian; Zhao, Xianxian; Fang, Weiyi; Wang, Changqian; Yin, Zhaofang; Wang, Jianan; Fu, Guosheng; Liu, Xuebo; Jiang, Jianjun; Zhang, Zhihui; Li, Jingbo; Lu, Yingmin; Ge, Junbo

    2017-09-01

    Available data show that approximately 8%-18% of patients with primary hypertension will develop resistant hypertension. In recent years, catheter-based renal denervation (RDN) has emerged as a potential treatment option for resistant hypertension. A number of observational studies and randomised controlled trials among non-Chinese patients have demonstrated its potential safety and efficacy. This is a multicentre, randomised, open-label, parallel-group, active controlled trial that will investigate the efficacy and safety of a 5F saline-irrigated radiofrequency ablation (RFA) used for RDN in the treatment of Chinese patients with resistant hypertension. A total of 254 patients who have failed pharmacological therapy will be enrolled. Eligible subjects will be randomised in a 1:1 ratio to undergo RDN using the RFA plus antihypertensive medication or to receive treatment with antihypertensive medication alone. The primary outcome measure is the change in 24 hours average ambulatory systolic blood pressure from baseline to 3 months, comparing the RDN-plus-medication group with the medication-alone group. Important secondary endpoints include the change in office blood pressure from baseline to 6 months after randomisation. Safety endpoints such as changes in renal function will also be evaluated. The full analysis set, according to the intent-to-treat principle, will be established as the primary analysis population. All participants will provide informed consent; the study protocol has been approved by the Independent Ethics Committee for each site. This study is designed to investigate the efficacy and safety of RDN using a 5F saline microirrigated RFA. Findings will be shared with participating hospitals, policymakers and the academic community to promote the clinical management of resistant hypertension in China. ClinicalTrials.gov ID: NCT02900729; pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017

  5. Influence of room heating on ambulatory blood pressure in winter: a randomised controlled study.

    Science.gov (United States)

    Saeki, Keigo; Obayashi, Kenji; Iwamoto, Junko; Tanaka, Yuu; Tanaka, Noriyuki; Takata, Shota; Kubo, Hiroko; Okamoto, Nozomi; Tomioka, Kimiko; Nezu, Satoko; Kurumatani, Norio

    2013-06-01

    Previous studies have proposed that higher blood pressure (BP) in winter is an important cause of increased mortality from cardiovascular disease during the winter. Some observational and physiological studies have shown that cold exposure increases BP, but evidence from a randomised controlled study assessing the effectiveness of intensive room heating for lowering BP was lacking. The present study aimed to determine whether intensive room heating in winter decreases ambulatory BP as compared with weak room heating resulting in a 10°C lower target room temperature when sufficient clothing and bedclothes are available. We conducted a parallel group, assessor blinded, simple randomised controlled study with 1:1 allocation among 146 healthy participants in Japan from November 2009 to March 2010. Ambulatory BP was measured while the participants stayed in single experimental rooms from 21:00 to 8:00. During the session, participants could adjust the amount of clothing and bedclothes as required. Compared with the weak room heating group (mean temperature ± SD: 13.9 ± 3.3°C), systolic morning BP (mean BP 2 h after getting out of bed) of the intensive room heating group (24.2 ± 1.7°C) was significantly lower by 5.8 mm Hg (95% CI 2.4 to 9.3). Sleep-trough morning BP surges (morning BP minus lowest night-time BP) in the intensive room heating group were significantly suppressed to about two thirds of the values in the weak room heating group (14.3 vs 21.9 mm Hg; pheating decreased morning BP and the morning BP surge in winter.

  6. Continuous quality improvement interventions to improve long-term outcomes of antiretroviral therapy in women who initiated therapy during pregnancy or breastfeeding in the Democratic Republic of Congo: design of an open-label, parallel, group randomized trial.

    Science.gov (United States)

    Yotebieng, Marcel; Behets, Frieda; Kawende, Bienvenu; Ravelomanana, Noro Lantoniaina Rosa; Tabala, Martine; Okitolonda, Emile W

    2017-04-26

    Despite the rapid adoption of the World Health Organization's 2013 guidelines, children continue to be infected with HIV perinatally because of sub-optimal adherence to the continuum of HIV care in maternal and child health (MCH) clinics. To achieve the UNAIDS goal of eliminating mother-to-child HIV transmission, multiple, adaptive interventions need to be implemented to improve adherence to the HIV continuum. The aim of this open label, parallel, group randomized trial is to evaluate the effectiveness of Continuous Quality Improvement (CQI) interventions implemented at facility and health district levels to improve retention in care and virological suppression through 24 months postpartum among pregnant and breastfeeding women receiving ART in MCH clinics in Kinshasa, Democratic Republic of Congo. Prior to randomization, the current monitoring and evaluation system will be strengthened to enable collection of high quality individual patient-level data necessary for timely indicators production and program outcomes monitoring to inform CQI interventions. Following randomization, in health districts randomized to CQI, quality improvement (QI) teams will be established at the district level and at MCH clinics level. For 18 months, QI teams will be brought together quarterly to identify key bottlenecks in the care delivery system using data from the monitoring system, develop an action plan to address those bottlenecks, and implement the action plan at the level of their district or clinics. If proven to be effective, CQI as designed here, could be scaled up rapidly in resource-scarce settings to accelerate progress towards the goal of an AIDS free generation. The protocol was retrospectively registered on February 7, 2017. ClinicalTrials.gov Identifier: NCT03048669 .

  7. Add-on treatment with N-acetylcysteine for bipolar depression: a 24-week randomized double-blind parallel group placebo-controlled multicentre trial (NACOS-study protocol).

    Science.gov (United States)

    Ellegaard, Pernille Kempel; Licht, Rasmus Wentzer; Poulsen, Henrik Enghusen; Nielsen, René Ernst; Berk, Michael; Dean, Olivia May; Mohebbi, Mohammadreza; Nielsen, Connie Thuroee

    2018-04-05

    Oxidative stress and inflammation may be involved in the development and progression of mood disorders, including bipolar disorder. Currently, there is a scarcity of useful treatment options for bipolar depressive episodes, especially compared with the efficacy of treatment for acute mania. N-Acetylcysteine (NAC) has been explored for psychiatric disorders for some time given its antioxidant and anti-inflammatory properties. The current trial aims at testing the clinical effects of adjunctive NAC treatment (compared to placebo) for bipolar depression. We will also explore the biological effects of NAC in this context. We hypothesize that adjunctive NAC treatment will reduce symptoms of depression, which will be reflected by changes in selected markers of oxidative stress. In the study, we will include adults diagnosed with bipolar disorder, in a currently depressive episode. Participants will undertake a 20-week, adjunctive, randomized, double-blinded, parallel group placebo-controlled trial comparing 3 grams of adjunctive NAC daily with placebo. The primary outcome is the mean change over time from baseline to end of study on the Montgomery-Asberg Depression Rating Scale (MADRS). Among the secondary outcomes are mean changes from baseline to end of study on the Bech-Rafaelsen Melancholia Scale (MES), the Young Mania Rating Scale (YMRS), the WHO-Five Well-being Index (WHO-5), the Global Assessment of Functioning scale (GAF-F), the Global Assessment of Symptoms scale (GAF-S) and the Clinical Global Impression-Severity scale (CGI-S). The potential effects on oxidative stress by NAC treatment will be measured through urine and blood samples. DNA will be examined for potential polymorphisms related to oxidative defences. Registered at The European Clinical Trials Database, ClinicalTrials.gov: NCT02294591 and The Danish Data Protection Agency: 2008-58-0035.

  8. A randomized, double-blind, placebo-controlled, multiple-dose, parallel-group clinical trial to assess the effects of teduglutide on gastric emptying of liquids in healthy subjects.

    Science.gov (United States)

    Berg, Jolene Kay; Kim, Eric H; Li, Benjamin; Joelsson, Bo; Youssef, Nader N

    2014-02-12

    Teduglutide, a recombinant analog of human glucagon-like peptide (GLP)-2, is a novel therapy recently approved for the treatment of adult patients with short bowel syndrome who are dependent on parenteral support. Previous studies assessing the effect of GLP-2 on gastric emptying in humans have yielded inconsistent results, with some studies showing no effect and others documenting a GLP-2-dependent delay in gastric emptying. The primary objective of this study was to assess the effect of teduglutide on gastric emptying of liquids in healthy subjects, as measured by the pharmacokinetics of acetaminophen. This double-blind, parallel-group, single-center study enrolled and randomized 36 healthy subjects (22 men, 14 women) to receive subcutaneous doses of teduglutide 4 mg or placebo (2:1 ratio; 23:13) once daily on Days 1 through 10 in the morning. Gastric emptying of a mixed nutrient liquid meal was assessed by measuring acetaminophen levels predose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 3.5, 4, 5, 6, 8, 10, 12, and 14 hours after administration of 1000 mg acetaminophen on Days 0 and 10. The primary study endpoint was a pharmacokinetic analysis of acetaminophen absorption in subjects receiving teduglutide or placebo. No significant differences in gastric emptying of liquids (acetaminophen area under the concentration [AUC] vs time curve from time 0 to the last measurable concentration, AUC extrapolated to infinity, maximum concentration [Cmax], and time to Cmax) were observed on Day 10 in subjects receiving teduglutide 4 mg versus subjects receiving placebo. There were no serious adverse events (AEs), deaths, or discontinuations due to an AE reported during the study. Teduglutide 4 mg/day for 10 days does not affect gastric emptying of liquids in healthy subjects as measured by acetaminophen pharmacokinetics. No unexpected safety signals were observed. This study was registered at ClinicalTrials.gov, identifier NCT01209351.

  9. The Influence of Hepatic and Renal Impairment on the Pharmacokinetics of a Treatment for Herpes Zoster, Amenamevir (ASP2151): Phase 1, Open-Label, Single-Dose, Parallel-Group Studies.

    Science.gov (United States)

    Kusawake, Tomohiro; Kowalski, Donna; Takada, Akitsugu; Kato, Kota; Katashima, Masataka; Keirns, James J; Lewand, Michaelene; Lasseter, Kenneth C; Marbury, Thomas C; Preston, Richard A

    2017-12-01

    Amenamevir (ASP2151) is a nonnucleoside human herpesvirus helicase-primase inhibitor that was approved in Japan for the treatment of herpes zoster (shingles) in 2017. This article reports the results of two clinical trials that investigated the effects of renal and hepatic impairment on the pharmacokinetics of amenamevir. These studies were phase 1, open-label, single-dose (oral 400 mg), parallel-group studies evaluating the pharmacokinetics, safety, and tolerability of amenamevir in healthy participants and participants with moderate hepatic impairment and mild, moderate, and severe renal impairment. In the hepatic impairment study, the pharmacokinetic profile of amenamevir in participants with moderate hepatic impairment was generally similar to that of participants with normal hepatic function. In the renal impairment study, the area under the amenamevir concentration versus time curve from the time of dosing up to the time of the last sample with extrapolation to infinity of the terminal phase was increased by 78.1% in participants with severe renal impairment. There was a positive relationship between creatinine clearance and oral and renal clearance for amenamevir in the renal impairment study. In both studies, amenamevir was safe and well tolerated. The findings of the hepatic impairment study indicate that no dosing adjustment is required in patients with moderate hepatic impairment. In the renal impairment study, systemic amenamevir exposure was increased by renal impairment. However, it is unlikely that renal impairment will have a significant effect on the safety of amenamevir given that in previous pharmacokinetic and safety studies in healthy individuals amenamevir was safe and well tolerated after a single dose (5-2400 mg, fasted condition) and repeated doses for 7 days (300 or 600 mg, fed condition), and the amount of amenamevir exposure in the renal impairment study was covered by those studies. These findings suggest that amenamevir does not

  10. A randomised, double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients.

    Science.gov (United States)

    Takamura, Etsuko; Tsubota, Kazuo; Watanabe, Hitoshi; Ohashi, Yuichi

    2012-10-01

    To compare the efficacy and safety of 3% diquafosol ophthalmic solution with those of 0.1% sodium hyaluronate ophthalmic solution in dry eye patients, using mean changes in fluorescein and rose bengal staining scores as endpoints. TRIAL DESIGN AND METHODS: In this multicenter, randomised, double-masked, parallel study of 286 dry eye patients with fluorescein and rose bengal staining scores of ≥3 were randomised to the treatment groups in a 1 : 1 ratio. Efficacy and safety were evaluated after drop-wise instillation of the study drug, six times daily for 4 weeks. After 4 weeks, the intergroup difference in the mean change from baseline in fluorescein staining score was -0.03; this verified the non-inferiority of diquafosol. The mean change from baseline in rose bengal staining score was significantly lower in the diquafosol group (p=0.010), thus verifying its superiority. The incidence of adverse events was 26.4% and 18.9% in the diquafosol and sodium hyaluronate groups, respectively, with no significant difference. Diquafosol (3%) and sodium hyaluronate (0.1%) exhibit similar efficacy in improving fluorescein staining scores of dry eye patients, whereas, diquafosol exhibits superior efficacy in improving rose bengal staining scores. Diquafosol has high clinical efficacy and is well tolerated with a good safety profile.

  11. Parallel discrete event simulation

    NARCIS (Netherlands)

    Overeinder, B.J.; Hertzberger, L.O.; Sloot, P.M.A.; Withagen, W.J.

    1991-01-01

    In simulating applications for execution on specific computing systems, the simulation performance figures must be known in a short period of time. One basic approach to the problem of reducing the required simulation time is the exploitation of parallelism. However, in parallelizing the simulation

  12. Parallel reservoir simulator computations

    International Nuclear Information System (INIS)

    Hemanth-Kumar, K.; Young, L.C.

    1995-01-01

    The adaptation of a reservoir simulator for parallel computations is described. The simulator was originally designed for vector processors. It performs approximately 99% of its calculations in vector/parallel mode and relative to scalar calculations it achieves speedups of 65 and 81 for black oil and EOS simulations, respectively on the CRAY C-90

  13. Pressure RElieving Support SUrfaces: a Randomised Evaluation 2 (PRESSURE 2): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Brown, Sarah; Smith, Isabelle L; Brown, Julia M; Hulme, Claire; McGinnis, Elizabeth; Stubbs, Nikki; Nelson, E Andrea; Muir, Delia; Rutherford, Claudia; Walker, Kay; Henderson, Valerie; Wilson, Lyn; Gilberts, Rachael; Collier, Howard; Fernandez, Catherine; Hartley, Suzanne; Bhogal, Moninder; Coleman, Susanne; Nixon, Jane E

    2016-12-20

    Pressure ulcers represent a major burden to patients, carers and the healthcare system, affecting approximately 1 in 17 hospital and 1 in 20 community patients. They impact greatly on an individual's functional status and health-related quality of life. The mainstay of pressure ulcer prevention practice is the provision of pressure redistribution support surfaces and patient repositioning. The aim of the PRESSURE 2 study is to compare the two main mattress types utilised within the NHS: high-specification foam and alternating pressure mattresses, in the prevention of pressure ulcers. PRESSURE 2 is a multicentre, open-label, randomised, double triangular, group sequential, parallel group trial. A maximum of 2954 'high-risk' patients with evidence of acute illness will be randomised on a 1:1 basis to receive either a high-specification foam mattress or alternating-pressure mattress in conjunction with an electric profiling bed frame. The primary objective of the trial is to compare mattresses in terms of the time to developing a new Category 2 or above pressure ulcer by 30 days post end of treatment phase. Secondary endpoints include time to developing new Category 1 and 3 or above pressure ulcers, time to healing of pre-existing Category 2 pressure ulcers, health-related quality of life, cost-effectiveness, incidence of mattress change and safety. Validation objectives are to determine the responsiveness of the Pressure Ulcer Quality of Life-Prevention instrument and the feasibility of having a blinded endpoint assessment using photography. The trial will have a maximum of three planned analyses with unequally spaced reviews at event-driven coherent cut-points. The futility boundaries are constructed as non-binding to allow a decision for stopping early to be overruled by the Data Monitoring and Ethics Committee. The double triangular, group sequential design of the PRESSURE 2 trial will provide an efficient design through the possibility of early stopping for

  14. Totally parallel multilevel algorithms

    Science.gov (United States)

    Frederickson, Paul O.

    1988-01-01

    Four totally parallel algorithms for the solution of a sparse linear system have common characteristics which become quite apparent when they are implemented on a highly parallel hypercube such as the CM2. These four algorithms are Parallel Superconvergent Multigrid (PSMG) of Frederickson and McBryan, Robust Multigrid (RMG) of Hackbusch, the FFT based Spectral Algorithm, and Parallel Cyclic Reduction. In fact, all four can be formulated as particular cases of the same totally parallel multilevel algorithm, which are referred to as TPMA. In certain cases the spectral radius of TPMA is zero, and it is recognized to be a direct algorithm. In many other cases the spectral radius, although not zero, is small enough that a single iteration per timestep keeps the local error within the required tolerance.

  15. Parallel computing works

    Energy Technology Data Exchange (ETDEWEB)

    1991-10-23

    An account of the Caltech Concurrent Computation Program (C{sup 3}P), a five year project that focused on answering the question: Can parallel computers be used to do large-scale scientific computations '' As the title indicates, the question is answered in the affirmative, by implementing numerous scientific applications on real parallel computers and doing computations that produced new scientific results. In the process of doing so, C{sup 3}P helped design and build several new computers, designed and implemented basic system software, developed algorithms for frequently used mathematical computations on massively parallel machines, devised performance models and measured the performance of many computers, and created a high performance computing facility based exclusively on parallel computers. While the initial focus of C{sup 3}P was the hypercube architecture developed by C. Seitz, many of the methods developed and lessons learned have been applied successfully on other massively parallel architectures.

  16. Massively parallel mathematical sieves

    Energy Technology Data Exchange (ETDEWEB)

    Montry, G.R.

    1989-01-01

    The Sieve of Eratosthenes is a well-known algorithm for finding all prime numbers in a given subset of integers. A parallel version of the Sieve is described that produces computational speedups over 800 on a hypercube with 1,024 processing elements for problems of fixed size. Computational speedups as high as 980 are achieved when the problem size per processor is fixed. The method of parallelization generalizes to other sieves and will be efficient on any ensemble architecture. We investigate two highly parallel sieves using scattered decomposition and compare their performance on a hypercube multiprocessor. A comparison of different parallelization techniques for the sieve illustrates the trade-offs necessary in the design and implementation of massively parallel algorithms for large ensemble computers.

  17. Combinatorics of spreads and parallelisms

    CERN Document Server

    Johnson, Norman

    2010-01-01

    Partitions of Vector Spaces Quasi-Subgeometry Partitions Finite Focal-SpreadsGeneralizing André SpreadsThe Going Up Construction for Focal-SpreadsSubgeometry Partitions Subgeometry and Quasi-Subgeometry Partitions Subgeometries from Focal-SpreadsExtended André SubgeometriesKantor's Flag-Transitive DesignsMaximal Additive Partial SpreadsSubplane Covered Nets and Baer Groups Partial Desarguesian t-Parallelisms Direct Products of Affine PlanesJha-Johnson SL(2,

  18. 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...

  19. Therapeutic Efficacy and Tolerability of the Topical Treatment of Inflammatory Conditions of the Oral Cavity with a Mouthwash Containing Diclofenac Epolamine : A Randomized, Investigator-Blind, Parallel-Group, Controlled, Phase III Study.

    Science.gov (United States)

    Serafini, Giampiero; Trevisan, Silvia; Saponati, Giorgio; Bandettini, Bernardo

    2012-01-01

    Non-steroidal anti-inflammatory drugs (NSAIDs), including diclofenac, are the mainstay of analgesic and anti-inflammatory treatment in dentistry. Diclofenac epolamine [diclofenac N-(2-hydroxyethyl)pyrrolidine; DHEP] is a diclofenac salt with greater water solubility and better cutaneous absorption properties than other commonly used forms of the drug. IBSA has recently developed a mouthwash formulation of DHEP for the topical treatment of inflammatory conditions of the oral cavity. The aim of this study was to compare the efficacy and tolerability of DHEP mouthwash (Osmal®) with that of a reference product (commercially available diclofenac mouthwash). This was a randomized, investigator-blind, parallel-group, controlled, phase III study that enrolled 80 patients with conditions affecting the oral cavity, characterized by an inflammatory component, and eligible for analgesic and anti-inflammatory treatment. Patients were randomized 1 : 1 to DHEP mouthwash (0.103% DHEP in aqueous solution) or to diclofenac mouthwash (0.074% free diclofenac in aqueous solution). The treatment regimen was the same in both groups: 1-minute rinse with 15 mL of mouthwash, twice daily for 7 days. Visits were scheduled at study inclusion (D0), and 3 days (D3) and 7 days (D7) after treatment initiation. During each visit assessments were made of pain severity (using a 5-point semi-quantitative scale and a 100-mm visual analogue scale [VAS]) and inflammatory signs (using a 5-point scale). The primary study endpoint was the change in pain severity scores from D0 to D3 and D7. Secondary endpoints included effects of treatment on inflammation score, quality of sleep, compliance with treatment and the safety and tolerability of treatment. The two treatment arms were homogeneous in terms of patient characteristics. The most prevalent oral condition was gingivitis. Overall both topical treatments were effective in alleviating pain and inflammation, as evidenced by decreases in pain and

  20. A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of the extended-release tramadol hydrochloride/acetaminophen fixed-dose combination tablet for the treatment of chronic low back pain.

    Science.gov (United States)

    Lee, Jae Hyup; Lee, Chong-Suh

    2013-11-01

    Chronic low back pain is a common condition that is often difficult to treat. The combination of tramadol hydrochloride and acetaminophen in an extended-release formulation has been shown to provide rapid and long-lasting analgesic effects resulting from the synergistic activity of these 2 active ingredients. The goal of this study was to evaluate the efficacy and safety of extended-release tramadol hydrochloride 75-mg/acetaminophen 650-mg fixed-dose combination tablets (TA-ER) for the treatment of chronic low back pain. This Phase III, double-blind, placebo-controlled, parallel-group study enrolled 245 patients with moderate to severe (≥4 cm on a 10-cm visual analog scale) chronic (≥3 months') low back pain insufficiently controlled by previous NSAIDs or cyclooxygenase-2-selective inhibitors and randomly assigned them to receive 4 weeks of either TA-ER or placebo. The primary efficacy end point was the percentage of patients with a pain intensity change rate ≥30% from baseline to final evaluation. Secondary end points included quality of life (Korean Short Form-36), functionality (Korean Oswestry Disability Index), and adverse events. The percentage of patients with a pain intensity change rate ≥30% was significantly higher (P Pain relief success rate from baseline was significantly higher with TA-ER versus placebo at days 8 and 15 but not at the final visit. Patients in the TA-ER group had significant improvements versus placebo in role-physical, general health, and reported health transition domains of the Korean Short Form-36 and significantly higher functional improvements in the personal care section of the Korean Oswestry Disability Index. Patient assessment of overall pain control as "very good" was also significantly higher with TA-ER than with placebo. Adverse events were reported more frequently with TA-ER than with placebo; the most common adverse events reported were nausea, dizziness, constipation, and vomiting. TA-ER was significantly more

  1. Anti-parallel triplexes

    DEFF Research Database (Denmark)

    Kosbar, Tamer R.; Sofan, Mamdouh A.; Waly, Mohamed A.

    2015-01-01

    about 6.1 °C when the TFO strand was modified with Z and the Watson-Crick strand with adenine-LNA (AL). The molecular modeling results showed that, in case of nucleobases Y and Z a hydrogen bond (1.69 and 1.72 Å, respectively) was formed between the protonated 3-aminopropyn-1-yl chain and one...... of the phosphate groups in Watson-Crick strand. Also, it was shown that the nucleobase Y made a good stacking and binding with the other nucleobases in the TFO and Watson-Crick duplex, respectively. In contrast, the nucleobase Z with LNA moiety was forced to twist out of plane of Watson-Crick base pair which......The phosphoramidites of DNA monomers of 7-(3-aminopropyn-1-yl)-8-aza-7-deazaadenine (Y) and 7-(3-aminopropyn-1-yl)-8-aza-7-deazaadenine LNA (Z) are synthesized, and the thermal stability at pH 7.2 and 8.2 of anti-parallel triplexes modified with these two monomers is determined. When, the anti...

  2. Protocol of the Low Birth Weight South Asia Trial (LBWSAT), a cluster-randomised controlled trial testing impact on birth weight and infant nutrition of Participatory Learning and Action through women's groups, with and without unconditional transfers of fortified food or cash during pregnancy in Nepal.

    Science.gov (United States)

    Saville, Naomi M; Shrestha, Bhim P; Style, Sarah; Harris-Fry, Helen; Beard, B James; Sengupta, Aman; Jha, Sonali; Rai, Anjana; Paudel, Vikas; Pulkki-Brannstrom, Anni-Maria; Copas, Andrew; Skordis-Worrall, Jolene; Bhandari, Bishnu; Neupane, Rishi; Morrison, Joanna; Gram, Lu; Sah, Raghbendra; Basnet, Machhindra; Harthan, Jayne; Manandhar, Dharma S; Osrin, David; Costello, Anthony

    2016-10-21

    Low birth weight (LBW, nutrition Participatory Learning and Action behaviour change strategy (PLA) for pregnant women through women's groups, with or without unconditional transfers of food or cash to pregnant women in two districts of southern Nepal. The study is a cluster randomised controlled trial (non-blinded). PLA comprises women's groups that discuss, and form strategies about, nutrition in pregnancy, low birth weight and hygiene. Women receive up to 7 monthly transfers per pregnancy: cash is NPR 750 (~US$7) and food is 10 kg of fortified sweetened wheat-soya Super Cereal per month. The unit of randomisation is a rural village development committee (VDC) cluster (population 4000-9200, mean 6150) in southern Dhanusha or Mahottari districts. 80 VDCs are randomised to four arms using a participatory 'tombola' method. Twenty clusters each receive: PLA; PLA plus food; PLA plus cash; and standard care (control). Participants are (mostly Maithili-speaking) pregnant women identified from 8 weeks' gestation onwards, and their infants (target sample size 8880 birth weights). After pregnancy verification, mothers may be followed up in early and late pregnancy, within 72 h, after 42 days and within 22 months of birth. Outcomes pertain to the individual level. Primary outcomes include birth weight within 72 h of birth and infant weight-for-age Z-score measured cross-sectionally on children born of the study. Secondary outcomes include prevalence of LBW, eating behaviour and weight during pregnancy, maternal and newborn illness, preterm delivery, miscarriage, stillbirth or neonatal mortality, infant Z-scores for length-for-age and weight-for-length, head circumference, and postnatal maternal BMI and mid-upper arm circumference. Exposure to women's groups, food or cash transfers, home visits, and group interventions are measured. Determining the relative importance to birth weight and early childhood nutrition of adding food or cash transfers to PLA women's groups

  3. 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

  4. The effect of escitalopram versus placebo on perceived stress and salivary cortisol in healthy first-degree relatives of patients with depression-A randomised trial

    DEFF Research Database (Denmark)

    Knorr, Ulla; Vinberg, Maj; Gether, Ulrik

    2012-01-01

    The effect of selective serotonin reuptake inhibitors (SSRI) on healthy individuals remains unclear. We tested the hypothesis that escitalopram decreases perceived stress and salivary cortisol. The trial has a randomised, blinded, placebo-controlled, parallel-group design. After informed consent 80...... intervals for the next hour, and at 12:00, 18:00 and 23:00. The salivary cortisol awakening response, all day salivary cortisol, and scale scores on sleep, pain, aggression, quality of life, and perceived stress assessed at entry were compared to values following 4 weeks of intervention. Statistically...... significant decreases were found in awakening salivary cortisol (P=0.04) and in all day salivary cortisol (P=0.02) in the escitalopram group compared with the placebo group. There were no statistically significant differences in perceived stress between the intervention groups. These findings from...

  5. ‘Third wave’ cognitive therapy versus mentalization-based therapy for major depressive disorder. A protocol for a randomised clinical trial

    Directory of Open Access Journals (Sweden)

    Jakobsen Janus Christian

    2012-12-01

    Full Text Available Abstract Background Most interventions for depression have shown small or no effects. ‘Third wave‘ cognitive therapy and mentalization-based therapy have both gained some ground as treatments of psychological problems. No randomised trial has compared the effects of these two interventions for patients with major depression. Methods/ design We plan a randomised, parallel group, assessor-blinded superiority clinical trial. During two years we will include 84 consecutive adult participants diagnosed with major depressive disorder. The participants will be randomised to either ‘third wave‘ cognitive therapy versus mentalization-based therapy. The primary outcome will be the Hamilton Rating Scale for Depression at cessation of treatment at 18 weeks. Secondary outcomes will be the proportion of patients with remission, Symptom Checklist 90 Revised, Beck’s Depression Inventory, and The World Health Organisation-Five Well-being Index 1999. Discussion Interventions for depression have until now shown relatively small effects. Our trial results will provide knowledge about the effects of two modern psychotherapeutic interventions. Trial registration ClinicalTrials: NCT01070134

  6. 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...

  7. Cerebral near infrared spectroscopy oximetry in extremely preterm infants : Phase II randomised clinical trial

    NARCIS (Netherlands)

    Hyttel-Sorensen, Simon; Pellicer, Adelina; Alderliesten, Thomas; Austin, Topun; Van Bel, Frank; Benders, Manon; Claris, Olivier; Dempsey, Eugene; Franz, Axel R.; Fumagalli, Monica; Gluud, Christian; Grevstad, Berit; Hagmann, Cornelia; Lemmers, Petra; Van Oeveren, Wim; Pichler, Gerhard; Plomgaard, Anne Mette; Riera, Joan; Sanchez, Laura; Winkel, Per; Wolf, Martin; Greisen, Gorm

    2015-01-01

    Objective: To determine if it is possible to stabilise the cerebral oxygenation of extremely preterm infants monitored by cerebral near infrared spectroscopy (NIRS) oximetry. Design: Phase II randomised, single blinded, parallel clinical trial. Setting Eight tertiary neonatal intensive care units in

  8. An exploratory, randomized, parallel-group, open-label, relative bioavailability study with an additional two-period crossover food-effect study exploring the pharmacokinetics of two novel formulations of pexmetinib (ARRY-614

    Directory of Open Access Journals (Sweden)

    Wollenberg LA

    2015-09-01

    Full Text Available Lance A Wollenberg,1 Donald T Corson,2,3 Courtney A Nugent,1 Farran L Peterson,1 Ann M Ptaszynski,1 Alisha Arrigo,2,3 Coralee G Mannila,2,3 Kevin S Litwiler,1 Stacie J Bell1,4 1Array BioPharma, Boulder, 2Array BioPharma, Longmont, CO, 3Avista Pharma Solutions, Longmont, CO, 4Mallinckrodt Pharmaceuticals, Ellicott City, MD, USA Background: Pexmetinib (ARRY-614 is a dual inhibitor of p38 mitogen-activated protein kinase and Tie2 signaling pathways implicated in the pathogenesis of myelodysplastic syndromes. Previous clinical experience in a Phase I dose-escalation study of myelodysplastic syndrome patients using pexmetinib administered as neat powder-in-capsule (PIC exhibited high variability in pharmacokinetics and excessive pill burden, prompting an effort to improve the formulation of pexmetinib. Methods: A relative bioavailability assessment encompassed three parallel treatment cohorts of unique subjects comparing the two new formulations (12 subjects per cohort, a liquid oral suspension (LOS and liquid-filled capsule (LFC and the current clinical PIC formulation (six subjects in a fasted state. The food-effect assessment was conducted as a crossover of the LOS and LFC formulations administered under fed and fasted conditions. Subjects were divided into two groups of equal size to evaluate potential period effects on the food-effect assessment. Results: The geometric mean values of the total plasma exposures based upon area-under-the-curve to the last quantifiable sample (AUClast of pexmetinib were approximately four- and twofold higher after administration of the LFC and LOS formulations, respectively, than after the PIC formulation, when the formulations were administered in the fasted state. When the LFC formulation was administered in the fed state, pexmetinib AUClast decreased by <5% compared with the fasted state. After administration of the LOS formulation in the fed state, pexmetinib AUClast was 34% greater than observed in the fasted

  9. A two-site, two-arm, 34-week, double-blind, parallel-group, randomized controlled trial of reduced nicotine cigarettes in smokers with mood and/or anxiety disorders: trial design and protocol

    Directory of Open Access Journals (Sweden)

    Sophia I. Allen

    2017-01-01

    Full Text Available Abstract Background The U.S. Food and Drug Administration can set standards for cigarettes that could include reducing their nicotine content. Such a standard should improve public health without causing unintended serious consequences for sub-populations. This study evaluates the effect of progressive nicotine reduction in cigarettes on smoking behavior, toxicant exposure, and psychiatric symptoms in smokers with comorbid mood and/or anxiety disorders using a two-site, two-arm, double-blind, parallel group, randomized controlled trial (RCT in four phases over 34 weeks. Methods Adult smokers (N = 200 of 5 or more cigarettes per day will be randomized across two sites (Penn State and Massachusetts General. Participants must have not had a quit attempt in the prior month, nor be planning to quit in the next 6 months, meet criteria for a current or lifetime unipolar mood and/or anxiety disorder based on the structured Mini-International Neuropsychiatric Interview, and must not have an unstable medical or psychiatric condition. After a week of smoking their own cigarettes, participants receive two weeks of Spectrum research cigarettes with usual nicotine content (11.6 mg. After this baseline period, participants will be randomly assigned to continue smoking Spectrum research cigarettes that contain either (a Usual Nicotine Content (11.6 mg; or (b Reduced Nicotine Content: the nicotine content per cigarette is progressively reduced from approximately 11.6 mg to 0.2 mg in five steps over 18 weeks. At the end of the randomization phase, participants will be offered the choice to either (a quit smoking with assistance, (b continue smoking free research cigarettes, or (c return to purchasing their own cigarettes, for the final 12 weeks of the study. The primary outcome measure is blood cotinine; key secondary outcomes are: exhaled carbon monoxide, urinary total NNAL- 4-(methylnitrosamino-1-(3-pyridyl-1-butanol and 1-hydroxypyrene, oxidative

  10. Algorithms for parallel computers

    International Nuclear Information System (INIS)

    Churchhouse, R.F.

    1985-01-01

    Until relatively recently almost all the algorithms for use on computers had been designed on the (usually unstated) assumption that they were to be run on single processor, serial machines. With the introduction of vector processors, array processors and interconnected systems of mainframes, minis and micros, however, various forms of parallelism have become available. The advantage of parallelism is that it offers increased overall processing speed but it also raises some fundamental questions, including: (i) which, if any, of the existing 'serial' algorithms can be adapted for use in the parallel mode. (ii) How close to optimal can such adapted algorithms be and, where relevant, what are the convergence criteria. (iii) How can we design new algorithms specifically for parallel systems. (iv) For multi-processor systems how can we handle the software aspects of the interprocessor communications. Aspects of these questions illustrated by examples are considered in these lectures. (orig.)

  11. Parallelism and array processing

    International Nuclear Information System (INIS)

    Zacharov, V.

    1983-01-01

    Modern computing, as well as the historical development of computing, has been dominated by sequential monoprocessing. Yet there is the alternative of parallelism, where several processes may be in concurrent execution. This alternative is discussed in a series of lectures, in which the main developments involving parallelism are considered, both from the standpoint of computing systems and that of applications that can exploit such systems. The lectures seek to discuss parallelism in a historical context, and to identify all the main aspects of concurrency in computation right up to the present time. Included will be consideration of the important question as to what use parallelism might be in the field of data processing. (orig.)

  12. Parallel magnetic resonance imaging

    International Nuclear Information System (INIS)

    Larkman, David J; Nunes, Rita G

    2007-01-01

    Parallel imaging has been the single biggest innovation in magnetic resonance imaging in the last decade. The use of multiple receiver coils to augment the time consuming Fourier encoding has reduced acquisition times significantly. This increase in speed comes at a time when other approaches to acquisition time reduction were reaching engineering and human limits. A brief summary of spatial encoding in MRI is followed by an introduction to the problem parallel imaging is designed to solve. There are a large number of parallel reconstruction algorithms; this article reviews a cross-section, SENSE, SMASH, g-SMASH and GRAPPA, selected to demonstrate the different approaches. Theoretical (the g-factor) and practical (coil design) limits to acquisition speed are reviewed. The practical implementation of parallel imaging is also discussed, in particular coil calibration. How to recognize potential failure modes and their associated artefacts are shown. Well-established applications including angiography, cardiac imaging and applications using echo planar imaging are reviewed and we discuss what makes a good application for parallel imaging. Finally, active research areas where parallel imaging is being used to improve data quality by repairing artefacted images are also reviewed. (invited topical review)

  13. Homeopathy for Perennial Asthma in Adolescents: Pilot Feasibility Study Testing a Randomised Withdrawal Design.

    Science.gov (United States)

    Mitchiguian Hotta, Livia; Cardinalli Adler, Ubiratan; de Toledo Cesar, Amarilys; Martinez, Edson Zangiacomi; Demarzo, Marcelo Marcos Piva

    2018-05-01

     Previous findings from a pragmatic trial suggest that usual care compared with usual care plus individualised homeopathy is not a feasible design to address homeopathic interventions for asthma.  The main purpose of this article was to investigate the feasibility of the randomised withdrawal design as a strategy to assess the effectiveness of a standardised clinical-pharmaceutical homeopathic protocol ( Organon.modus ) on perennial asthma in adolescents.  Randomised withdrawal, double-blind, parallel, placebo-controlled, 12-week study. 12 to 17 years old adolescents, with the diagnosis of perennial asthma, using inhalatory beclomethasone (plus fenoterol for wheezing episodes), who achieved 3 months of well-controlled asthma, after a variable period of individualised homeopathic treatment according to Organon.modus protocol. a secondary care medical specialist centre. continuation with the individualised homeopathic medicine or with indistinguishable placebo during 12 weeks of beclomethasone step-down. number of days of well-controlled asthma. Secondary measures: number of days of fenoterol use, number of visits to an emergency service (without hospitalisation) and percentage of patients excluded due to an exacerbation characterising a partly controlled asthma. Tolerability was assessed by Adverse Events, registered at every visit.  Nineteen patients were randomised to continue treatment with homeopathy and 21 with placebo. Effectiveness measures for the homeopathy and placebo groups respectively were median number of days of good clinical control: 84 versus 30 ( p  = 0.18); median number of days of fenoterol use per patient: 3 versus 5 ( p  = 0.41); visits to an emergency room: 1 versus 6 ( p  = 0.35); percentage of exclusion due to partly controlled asthma: 36.8% versus 71.4% ( p  = 0.05). Few Adverse Events were reported.  This pilot study supports the feasibility of the double-blind randomised withdrawal design in studies investigating

  14. The RAPID-CTCA trial (Rapid Assessment of Potential Ischaemic Heart Disease with CTCA) - a multicentre parallel-group randomised trial to compare early computerised tomography coronary angiography versus standard care in patients presenting with suspected or confirmed acute coronary syndrome: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Gray, Alasdair J; Roobottom, Carl; Smith, Jason E; Goodacre, Steve; Oatey, Katherine; O'Brien, Rachel; Storey, Robert F; Na, Lumine; Lewis, Steff C; Thokala, Praveen; Newby, David E

    2016-12-07

    Emergency department attendances with chest pain requiring assessment for acute coronary syndrome (ACS) are a major global health issue. Standard assessment includes history, examination, electrocardiogram (ECG) and serial troponin testing. Computerised tomography coronary angiography (CTCA) enables additional anatomical assessment of patients for coronary artery disease (CAD) but has only been studied in very low-risk patients. This trial aims to investigate the effect of early CTCA upon interventions, event rates and health care costs in patients with suspected/confirmed ACS who are at intermediate risk. Participants will be recruited in about 35 tertiary and district general hospitals in the UK. Patients ≥18 years old with symptoms with suspected/confirmed ACS with at least one of the following will be included: (1) ECG abnormalities, e.g. ST-segment depression >0.5 mm; (2) history of ischaemic heart disease; (3) troponin elevation above the 99 th centile of the normal reference range or increase in high-sensitivity troponin meeting European Society of Cardiology criteria for 'rule-in' of myocardial infarction (MI). The early use of ≥64-slice CTCA as part of routine assessment will be compared to standard care. The primary endpoint will be 1-year all-cause death or recurrent type 1 or type 4b MI at 1 year, measured as the time to such event. A number of secondary clinical, process and safety endpoints will be collected and analysed. Cost effectiveness will be estimated in terms of the lifetime incremental cost per quality-adjusted life year gained. We plan to recruit 2424 (2500 with ~3% drop-out) evaluable patients (1212 per arm) to have 90% power to detect a 20% versus 15% difference in 1-year death or recurrent type 1 MI or type 4b MI, two-sided p Acute Coronary Events score, previous CAD and baseline troponin level. The results will be expressed as a hazard ratio with the corresponding 95% confidence intervals and p value. The Rapid Assessment of Potential Ischaemic Heart Disease with CTCA (RAPID-CTCA) trial will recruit 2500 participants across about 35 hospital sites. It will be the first study to investigate the role of CTCA in the early assessment of patients with suspected or confirmed ACS who are at intermediate risk and including patients who have raised troponin measurements during initial assessment. ISRCTN19102565 . Registered on 3 October 2014. ClinicalTrials.gov: NCT02284191.

  15. Adductor canal block for post-operative analgesia after simultaneous bilateral total knee replacement: A randomised controlled trial to study the effect of addition of dexmedetomidine to ropivacaine

    Directory of Open Access Journals (Sweden)

    Rakhee Goyal

    2017-01-01

    Full Text Available Background and Aims: Knee replacement surgery causes tremendous post-operative pain and adductor canal block (ACB is used for post-operative analgesia. This is a randomised, controlled, three-arm parallel group study using different doses of dexmedetomidine added to ropiavcaine for ACB. Methods: A total of 150 patients aged 18–75 years, scheduled for simultaneous bilateral total knee replacement, received ultrasound-guided ACB. They were randomised into three groups -Group A received ACB with plain ropivacaine; Groups B and C received ACB with ropivacaine and addition of dexmedetomidine 0.25 μg/kg and 0.50 μg/kg, respectively, on each side of ACB. The primary outcome was the duration of analgesia. Total opioid consumption, success of early ambulation, and level of patient satisfaction were also assessed. Results: The patient characteristics and block success rates were comparable in all groups. Group C patients had longer duration of analgesia (Group C 18.4 h ± 7.4; Group B 14.6 ± 7.1; Group A 10.8 ± 7; P < 0.001; lesser tramadol consumption (Group C 43.8 mg ± 53.2; Group B 76.4 ± 49.6; Group A 93.9 mg ± 58.3; P < 0.001 and lesser pain on movement (P < 0.001. The patients in Group B and C walked more steps than in Group A (P < 0.002. The level of patient satisfaction was highest in Group C (P < 0.001. Conclusions: The addition of dexmedetomidine to ropivacaine resulted in longer duration of analgesia after adductor canal block for simultaneous bilateral total knee replacement surgery.

  16. Parallel R-matrix computation

    International Nuclear Information System (INIS)

    Heggarty, J.W.

    1999-06-01

    For almost thirty years, sequential R-matrix computation has been used by atomic physics research groups, from around the world, to model collision phenomena involving the scattering of electrons or positrons with atomic or molecular targets. As considerable progress has been made in the understanding of fundamental scattering processes, new data, obtained from more complex calculations, is of current interest to experimentalists. Performing such calculations, however, places considerable demands on the computational resources to be provided by the target machine, in terms of both processor speed and memory requirement. Indeed, in some instances the computational requirements are so great that the proposed R-matrix calculations are intractable, even when utilising contemporary classic supercomputers. Historically, increases in the computational requirements of R-matrix computation were accommodated by porting the problem codes to a more powerful classic supercomputer. Although this approach has been successful in the past, it is no longer considered to be a satisfactory solution due to the limitations of current (and future) Von Neumann machines. As a consequence, there has been considerable interest in the high performance multicomputers, that have emerged over the last decade which appear to offer the computational resources required by contemporary R-matrix research. Unfortunately, developing codes for these machines is not as simple a task as it was to develop codes for successive classic supercomputers. The difficulty arises from the considerable differences in the computing models that exist between the two types of machine and results in the programming of multicomputers to be widely acknowledged as a difficult, time consuming and error-prone task. Nevertheless, unless parallel R-matrix computation is realised, important theoretical and experimental atomic physics research will continue to be hindered. This thesis describes work that was undertaken in

  17. Hypnosis Antenatal Training for Childbirth (HATCh: a randomised controlled trial [NCT00282204

    Directory of Open Access Journals (Sweden)

    Baghurst Peter

    2006-03-01

    Full Text Available Abstract Background Although medical interventions play an important role in preserving lives and maternal comfort they have become increasingly routine in normal childbirth. This may increase the risk of associated complications and a less satisfactory birth experience. Antenatal hypnosis is associated with a reduced need for pharmacological interventions during childbirth. This trial seeks to determine the efficacy or otherwise of antenatal group hypnosis preparation for childbirth in late pregnancy. Methods/design A single centre, randomised controlled trial using a 3 arm parallel group design in the largest tertiary maternity unit in South Australia. Group 1 participants receive antenatal hypnosis training in preparation for childbirth administered by a qualified hypnotherapist with the use of an audio compact disc on hypnosis for re-enforcement; Group 2 consists of antenatal hypnosis training in preparation for childbirth using an audio compact disc on hypnosis administered by a nurse with no training in hypnotherapy; Group 3 participants continue with their usual preparation for childbirth with no additional intervention. Women > 34 and Discussion If effective, hypnosis would be a simple, inexpensive way to improve the childbirth experience, reduce complications associated with pharmacological interventions, yield cost savings in maternity care, and this trial will provide evidence to guide clinical practice.

  18. Bimatoprost 0.03%/timolol 0.5% preservative-free ophthalmic solution versus bimatoprost 0.03%/timolol 0.5% ophthalmic solution (Ganfort) for glaucoma or ocular hypertension: a 12-week randomised controlled trial

    Science.gov (United States)

    Goldberg, Ivan; Gil Pina, Rafael; Lanzagorta-Aresti, Aitor; Schiffman, Rhett M; Liu, Charlie; Bejanian, Marina

    2014-01-01

    Aim To compare the efficacy and safety of single-dose bimatoprost 0.03%/timolol 0.5% preservative-free (PF) ophthalmic solution with bimatoprost 0.03%/timolol 0.5% ophthalmic solution in patients with open-angle glaucoma or ocular hypertension. Methods In this multicentre, randomised, parallel-group study, patients were randomised to bimatoprost/timolol PF or bimatoprost/timolol once daily in the morning for 12 weeks. Primary efficacy endpoints, reflecting differing regional regulatory requirements, included change from baseline in worse eye intraocular pressure (IOP) in the per-protocol population at week 12, and the average eye IOP at weeks 2, 6 and 12 in the intent-to-treat population. Results 561 patients were randomised (278 to bimatoprost/timolol PF; 283 to bimatoprost/timolol); 96.3% completed the study. Both treatment groups showed statistically and clinically significant mean decreases from baseline in worse eye IOP and in average eye IOP at all follow-up time points (p<0.001). Bimatoprost/timolol PF met all pre-established criteria for non-inferiority and equivalence to bimatoprost/timolol. Ocular adverse events were similar between treatment groups, with conjunctival hyperaemia being the most frequent. Most were mild or moderate in severity. Conclusions Bimatoprost/timolol PF demonstrated non-inferiority and equivalence in IOP lowering compared with bimatoprost/timolol, with no significant differences in safety and tolerability. Trial registration number NCT01177098. PMID:24667994

  19. Patient satisfaction with occlusal scheme of conventional complete dentures: A randomised clinical trial (part I).

    Science.gov (United States)

    Moradpoor, H; Arabzade Hoseini, M; Savabi, O; Shirani, M

    2018-01-01

    Occlusal scheme can affect denture retention, stability, occlusal force distribution, aesthetics, masticatory function, patient comfort and general patient satisfaction with dentures. This study aimed to compare the patient satisfaction with 3 types of complete denture occlusion including fully bilateral balanced occlusion (FBBO), newly presented buccalised occlusion (BO) and lingualised occlusion (LO). In this parallel randomised clinical trial, new conventional complete dentures were fabricated for 86 volunteers. Participants were randomly allocated to 3 groups with 3 different occlusal schemes. All patients were recalled at 1 and 3 months after delivery for data collection. The 19-item version of Oral Health Impact Profile for Edentulous Patients questionnaire was used in this study. The visual analogue scale (VAS) was used for assessment of the prosthodontist's attitude towards denture quality, patient's attitude towards different occlusal schemes and evaluation of patient satisfaction. Data were analysed using the Wilcoxon signed rank test, the Kruskal-Wallis test and the post hoc Dunn test via SPSS version 18.0 (P ≤ .05). Eighty-six patients completed the study, and their data were analysed (mean age ± standard deviation = 57.78 ± 9.98 years). The only significant difference when comparing the 3 groups was physical pain, which was significantly higher in FBBO group. No significant differences were found for the VAS scores of patient and prosthodontist satisfaction or the domain scores among the 3 occlusal schemes either at 1 or at 3 months post-delivery. The VAS score of patient satisfaction and prosthodontist satisfaction increased at third compared to first month after delivery. The results of this randomised clinical trial provided evidence that BO is as effective as LO for the fabrication of complete dentures. © 2017 John Wiley & Sons Ltd.

  20. Automatic Parallelization Tool: Classification of Program Code for Parallel Computing

    Directory of Open Access Journals (Sweden)

    Mustafa Basthikodi

    2016-04-01

    Full Text Available Performance growth of single-core processors has come to a halt in the past decade, but was re-enabled by the introduction of parallelism in processors. Multicore frameworks along with Graphical Processing Units empowered to enhance parallelism broadly. Couples of compilers are updated to developing challenges forsynchronization and threading issues. Appropriate program and algorithm classifications will have advantage to a great extent to the group of software engineers to get opportunities for effective parallelization. In present work we investigated current species for classification of algorithms, in that related work on classification is discussed along with the comparison of issues that challenges the classification. The set of algorithms are chosen which matches the structure with different issues and perform given task. We have tested these algorithms utilizing existing automatic species extraction toolsalong with Bones compiler. We have added functionalities to existing tool, providing a more detailed characterization. The contributions of our work include support for pointer arithmetic, conditional and incremental statements, user defined types, constants and mathematical functions. With this, we can retain significant data which is not captured by original speciesof algorithms. We executed new theories into the device, empowering automatic characterization of program code.

  1. The STAPL Parallel Graph Library

    KAUST Repository

    Harshvardhan,; Fidel, Adam; Amato, Nancy M.; Rauchwerger, Lawrence

    2013-01-01

    This paper describes the stapl Parallel Graph Library, a high-level framework that abstracts the user from data-distribution and parallelism details and allows them to concentrate on parallel graph algorithm development. It includes a customizable

  2. 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

  3. 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

  4. Long-term effect of inhaled budesonide in mild and moderate chronic obstructive pulmonary disease: a randomised controlled trial

    DEFF Research Database (Denmark)

    Vestbo, Jørgen; Sørensen, T; Lange, Peter

    1999-01-01

    BACKGROUND: Little is known about the long-term efficacy of inhaled corticosteroids in chronic obstructive pulmonary disease (COPD). We investigated the efficacy of inhaled budesonide on decline in lung function and respiratory symptoms in a 3-year placebo-controlled study of patients with COPD....... METHODS: We used a parallel-group, randomised, double-blind, placebo-controlled design in a singlecentre study, nested in a continuing epidemiological survey (the Copenhagen City Heart Study). Inclusion criteria were as follows: no asthma; a ratio of forced expiratory volume in 1 s (FEV1) and vital...... capacity of 0.7 or less; FEV1 which showed no response (budesonide, 800 microg plus 400 microg daily for 6 months followed by 400 microg twice daily for 30 months, or placebo...

  5. An open, randomized, parallel-group study to compare the efficacy and safety profile of inhaled human insulin (exubera) with meformin as adjunctive therapy in patients with type 2 diabetes poorly controlled on a sulfonylurea: response to mikhail and cope

    DEFF Research Database (Denmark)

    Barnett, Anthony H.; Dreyer, Manfred; Lange, Peter

    2006-01-01

    OBJECTIVE: To compare the efficacy and safety profile of adding inhaled human insulin (INH; Exubera) or metformin to sulfonylurea monotherapy in patients with poorly controlled type 2 diabetes. RESEARCH DESIGN AND METHODS: We performed an open-label, parallel, 24-week, multicenter trial. At week -1......: In patients with type 2 diabetes poorly controlled on a sulfonylurea (A1C >9.5%), the addition of premeal INH significantly improves glycemic control compared with adjunctive metformin and is well tolerated....

  6. The Effect of Souvenaid on Functional Brain Network Organisation in Patients with Mild Alzheimer’s Disease: A Randomised Controlled Study

    Science.gov (United States)

    de Waal, Hanneke; Stam, Cornelis J.; Lansbergen, Marieke M.; Wieggers, Rico L.; Kamphuis, Patrick J. G. H.; Scheltens, Philip; Maestú, Fernando; van Straaten, Elisabeth C. W.

    2014-01-01

    Background Synaptic loss is a major hallmark of Alzheimer’s disease (AD). Disturbed organisation of large-scale functional brain networks in AD might reflect synaptic loss and disrupted neuronal communication. The medical food Souvenaid, containing the specific nutrient combination Fortasyn Connect, is designed to enhance synapse formation and function and has been shown to improve memory performance in patients with mild AD in two randomised controlled trials. Objective To explore the effect of Souvenaid compared to control product on brain activity-based networks, as a derivative of underlying synaptic function, in patients with mild AD. Design A 24-week randomised, controlled, double-blind, parallel-group, multi-country study. Participants 179 drug-naïve mild AD patients who participated in the Souvenir II study. Intervention Patients were randomised 1∶1 to receive Souvenaid or an iso-caloric control product once daily for 24 weeks. Outcome In a secondary analysis of the Souvenir II study, electroencephalography (EEG) brain networks were constructed and graph theory was used to quantify complex brain structure. Local brain network connectivity (normalised clustering coefficient gamma) and global network integration (normalised characteristic path length lambda) were compared between study groups, and related to memory performance. Results The network measures in the beta band were significantly different between groups: they decreased in the control group, but remained relatively unchanged in the active group. No consistent relationship was found between these network measures and memory performance. Conclusions The current results suggest that Souvenaid preserves the organisation of brain networks in patients with mild AD within 24 weeks, hypothetically counteracting the progressive network disruption over time in AD. The results strengthen the hypothesis that Souvenaid affects synaptic integrity and function. Secondly, we conclude that advanced EEG

  7. Massively parallel multicanonical simulations

    Science.gov (United States)

    Gross, Jonathan; Zierenberg, Johannes; Weigel, Martin; Janke, Wolfhard

    2018-03-01

    Generalized-ensemble Monte Carlo simulations such as the multicanonical method and similar techniques are among the most efficient approaches for simulations of systems undergoing discontinuous phase transitions or with rugged free-energy landscapes. As Markov chain methods, they are inherently serial computationally. It was demonstrated recently, however, that a combination of independent simulations that communicate weight updates at variable intervals allows for the efficient utilization of parallel computational resources for multicanonical simulations. Implementing this approach for the many-thread architecture provided by current generations of graphics processing units (GPUs), we show how it can be efficiently employed with of the order of 104 parallel walkers and beyond, thus constituting a versatile tool for Monte Carlo simulations in the era of massively parallel computing. We provide the fully documented source code for the approach applied to the paradigmatic example of the two-dimensional Ising model as starting point and reference for practitioners in the field.

  8. Randomised trial of biofeedback training for encopresis.

    Science.