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Articles de revues sur le sujet "Moduli randomisation"

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Dupont, Christophe, Jeroen Hol et Edward E. S. Nieuwenhuis. « An extensively hydrolysed casein-based formula for infants with cows' milk protein allergy : tolerance/hypo-allergenicity and growth catch-up ». British Journal of Nutrition 113, no 7 (17 mars 2015) : 1102–12. http://dx.doi.org/10.1017/s000711451500015x.

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Children with cows' milk protein allergy (CMPA) are at risk of insufficient length and weight gain, and the nutritional efficacy of hypo-allergenic formulas should be carefully assessed. In 2008, a trial assessed the impact of probiotic supplementation of an extensively hydrolysed casein-based formula (eHCF) on acquisition of tolerance in 119 infants with CMPA. First analysis of the study results showed that the studied formula allowed improvement of food-related symptoms. The scoring of atopic dermatitis (SCORAD) index was assessed at randomisation and after 6 months of feeding. A post hoc analysis was performed using WHO growth software's nutritional survey module (WHO Anthro version 3.2.2). All infants who were fed the study formula tolerated it well. The SCORAD index significantly improved from randomisation to 6 months of feeding with the study formula. Anthropometric data indicated a significant improvement in the weight-for-age, length-for-age and weight-for-length z scores, as well as in the restoration of normal BMI. The probiotic supplementation did not show any impact on these parameters. The present data showed that this eHCF was clinically tolerated and significantly improved the SCORAD index and growth indices.
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Ahmedzai, Sam H., John A. Snowden, Angela Cox, David A. Cairns, Cathy D. Williams, Anna Hockaday, Jamie Cavenagh et al. « Patient-Reported Outcomes (PRO) in the Setting of Relapsed Myeloma : The Influence of Treatment Strategies and Genetic Variants Predict Quality of Life and Pain Experience ». Blood 126, no 23 (3 décembre 2015) : 3180. http://dx.doi.org/10.1182/blood.v126.23.3180.3180.

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Abstract Introduction. The impact of therapy in the management of disease relapse in patients with myeloma (MM) needs to be balanced with the impact on quality of life (QoL). The benefit of a salvage autologous stem cell transplant (ASCT2) has been demonstrated in terms of durability of response over non-transplant consolidation (NTC) (G Cook, et al., Lancet Oncology, 2013 Vol. 15, No. 8, p874-885). However, the impact of ASCT2 on patient reported outcomes (PRO) has not been reported to date. Therefore, patients' experience of pain and global measures of QoL, as part of a systematic assessment of PRO were measured at key points before, during and after randomisation in this multi-centre national phase III trial. Methods. 174 patients were randomised and data are presented on 171 who completed self-rated QoL assessments using EORTC QLQ-C30 and the EORTC myeloma module (MY-20). Pain assessments using BPI-SF were also incorporated. Genomic DNA was prepared from PBMNC using standardised GLP methods. Results. Completion rates for EORTC QoL and BPI-SF assessments were 83.3% and 77.1% at registration, and 59.6% and 53.8% at randomisation, respectively. Over half of patients reaching 1 year post-randomisation completed both assessments. EORTC QoL and BPI-SF forms had average 6% and 10% missing data, respectively. These completion rates are commensurate with previous longitudinal studies. EORTC QLQ-C30 Global health status/QoL subscale scores were significantly higher (better) in the NTC arm at 100 days and 6 month post-randomisation (P=0.0496), but not at later time points. BPI-SF pain scores showed significantly higher pain severity in the NTC (4.3/10) than the ASCT2 (2.9/10) patients only at 2 years post-randomisation. However, for pain interference with aspects of daily living, NTC patients reported significantly lower scores at 6 months (P=0.0155), 1 year post-randomisation (P=0.0466) and 2 years post-randomisation (P=0.0348). The MY-20 assessment showed that at 100 days and 6 months post-randomisation, the subscale scores for Side-effects of treatment were significantly higher in the ASCT2 arm than in the NTC arm, but not at later time points up to 2 years. Kaplan-Meier estimate of time-to-progression (TTP) by randomised allocation suggested that patients with an EORTC global QoL score greater than median (ie better QoL) at randomisation and who received ASCT2 had a significant TTP advantage over those receiving NTC (HR 0.3 (95% CI 0.15-0.61), p=0.006). However, with multivariate Cox regression analysis accounting for stratification factors this difference was not significant. Patients who reported a lower (ie better) than median level of concern on the Side-effects of treatment subscale and who received ASCT2 had a significant TTP advantage over those receiving NTC (Kaplan-Meier HR 0.24 (95% CI (0.10-0.55), p=0.003). This survival difference was still observed after multivariate Cox regression analysis (HR 5.02 (95% CI 1.00-25.20), p= 0.0499). We tested for genomic associations of SNPs from key genes reported to be involved in pain perception and analgesic responsiveness, and subjective outcomes. There were no significant associations for the opioid mu-receptor (OPRM1) and pain or QoL. However, the rs2236861 SNP in the opioid delta-receptor (OPRD1) showed nominally significant associations with worst pain (p=0.022), average pain (p=0.03) and pain interference (p=0.02) at baseline. The rs1045642 SNP in the ABCB1 drug transporter gene was nominally associated with worst pain (p=0.047) and average pain (p=0.019) after bortezomib-based induction therapy. A SNP rs13361160 in the chaperonin CCT5 gene was associated with worst pain (p=0.033), least pain (p=0.006) and pain interference (p=0.03). It was also associated with self-reported global QoL (P=0.014). Conclusions. We report the first PROs using self-reported QoL and pain assessments in myeloma patients having salvage ASCT or NTC. Global QoL was worse and side-effects of treatment higher after ASCT2 for up to 6 months post-randomisation but then equalised. Pain caused less interference with daily living after NTC but became more severe at 2 years, possibly associated with relapse. Patients who reported lower concerns about side-effects of treatment after ASCT2 had a significant TTP advantage. The genomic analyses suggest a potential inherited predisposition that influences both pain and quality of life and warrants further exploration. Disclosures Ahmedzai: Mundipharma: Consultancy, Speakers Bureau; AstraZeneca: Consultancy, Research Funding, Speakers Bureau; Grunenthal: Consultancy, Research Funding, Speakers Bureau. Snowden:Sanofi: Consultancy; MSD: Consultancy, Other: Educational support, Speakers Bureau; Janssen: Other: Educational support, Speakers Bureau; Celgene: Other: Educational support, Speakers Bureau. Williams:Janssen: Consultancy, Honoraria, Speakers Bureau; Celgene: Consultancy, Speakers Bureau; Amgen: Consultancy, Speakers Bureau; Takeda: Consultancy, Speakers Bureau. Cavenagh:Janssen: Consultancy, Speakers Bureau; Novartis: Consultancy, Speakers Bureau; Celgene: Consultancy, Speakers Bureau; Amgen: Consultancy, Speakers Bureau. Parrish:Janssen: Speakers Bureau; Celgene: Speakers Bureau. Yong:Amgen: Honoraria; Novartis: Consultancy; Takeda: Honoraria; BMS: Honoraria; Janssen: Honoraria; Autolous: Consultancy. Cavet:Celgene: Consultancy, Research Funding, Speakers Bureau; Janssen: Consultancy, Research Funding, Speakers Bureau. Bird:Celgene: Speakers Bureau; Janssen: Other: Educational support; Amgen: Consultancy; Novartis: Consultancy; Pfizer: Consultancy. Ashcroft:Janssen: Consultancy, Other: Educational support. Brown:Bayer: Research Funding; Roche: Research Funding; Celgene: Research Funding; Janssen: Research Funding. Morris:Celgene: Other: Meeting support; Janssen: Other: Meeting support. Cook:Celgene: Consultancy, Research Funding, Speakers Bureau; Janssen: Consultancy, Research Funding, Speakers Bureau; BMS: Consultancy; Takeda Oncology: Consultancy, Research Funding, Speakers Bureau; Sanofi: Consultancy, Speakers Bureau; Amgen: Consultancy, Speakers Bureau.
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Lincoln, Tania M., Matthias Pillny, Björn Schlier et Mark Hayward. « RELATE—a randomised controlled feasibility trial of a Relating Therapy module for distressing auditory verbal hallucinations : a study protocol ». BMJ Open 11, no 6 (juin 2021) : e046390. http://dx.doi.org/10.1136/bmjopen-2020-046390.

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IntroductionAuditory verbal hallucinations (AVHs) are associated with distress and reduced functioning. Research suggests that distress is associated with the voice hearer’s responding to AVH in a passive and subordinate manner. A novel approach focuses on relating to AVH and teaches assertive responses to AVH using experiential role-plays. A small pilot study found a large effect of this approach on AVH distress but an independent multicentre study is required to ascertain effectiveness across different settings. We aim to estimate the expected effect for a subsequent trial to demonstrate that adding a module of Relating Therapy (RT) to treatment as usual (TAU) is superior to TAU alone in reducing AVH distress. We also test the feasibility of patient recruitment, therapist training, and therapy monitoring in different psychological and psychiatric outpatient facilities in Germany.Methods and analysisWe will recruit 75 patients diagnosed with a schizophrenia spectrum disorder and persistent distressing AVH across four sites. Patients will be randomised to receive either 16 sessions of RT plus TAU or TAU alone within a 5-month period. Randomisation will be stratified by sites. Single-blind assessments will take place at baseline, at 5 months (T1) and at 9 months (T2). The primary outcome is the distress factor score of the AVH subscale of the Psychotic Symptoms Rating Scale at T2 adjusted for the baseline value. Secondary outcomes are change in depressive symptoms, quality of life, time spent in structured activities as well as negative relating to voices and to other people.Ethics and disseminationThe trial has received ethical approval from the German Psychological Society Ethics Committee. The trial results will be disseminated through conference presentations, peer-reviewed publications and social media.Trial registration numberClinicalTrials.gov Registry (NCT04578314).
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Dapari, Rahmat, Mohd Hafizuddin Mahfot, Mohd ‘Ammar Ihsan Ahmad Zamzuri, Zaleha Md Isa, Mohd Rohaizat Hassan, Nazri Che Dom et Syed Sharizman Syed Abdul Rahim. « Theory-Based Intervention Module on Occupational Safety and Health (TRIMOSH) in improving knowledge, attitude, and practice among food industry workers : Study protocol for a randomised controlled trial ». PLOS ONE 19, no 1 (2 janvier 2024) : e0295771. http://dx.doi.org/10.1371/journal.pone.0295771.

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Introduction The significant contribution of the food and beverage industry to Malaysia’s Gross Domestic Product is projected to increase in the upcoming years. With the industry’s expansion, the demand for workers on food premises would also continuously increase. The food industry workers are exposed to risks arising from physical, chemical, biological, ergonomic, and psychosocial hazards while performing their duties. Thus, it is essential for these workers to be equipped with proper knowledge, attitude, and practices (KAP) in safety and health. Aims This study aims to develop and evaluate the effectiveness of the safety and health programme TRIMOSH (Theory-Based Intervention Module on Occupational Safety and Health) in improving the knowledge, attitude, and practice among food industry workers. Methods TRIMOSH intervention study is a two-arm randomised, single-blinded, controlled, parallel trial that will be conducted among food industry workers in Selangor, Malaysia. In a partnership with Food Handler Training Schools in Selangor, 10 pairs of Food Handler Training Schools with 12 participants per group (n = 240) will be recruited for balanced randomisation intervention and control conditions. Furthermore, data collection of all participants was conducted at four time points: baseline (T0), immediately (T1), one month (T2), and three months (T3) post-intervention. Generalised Linear Mixed Model (GLMM) will be conducted to determine the effects of intervention within and between study groups. Subsequently, the primary outcomes increase the knowledge, attitude, and practice (KAP) of safety and health at food premises. Clinical Trial Registry registration was approved by the ClinicalTrials.gov committee on October 2022 with the ClinicalTrials.gov Identifier: NCT05571995. This study has also been approved by the Ethics Committee for Research Involving Human Subjects of Universiti Putra Malaysia (JKEUPM-2022-346). All participants are required to provide consent prior to participation. Conclusions The characteristics of the respondents are expected to show no difference between the groups. It is hypothesised that TRIMOSH is effective in improving the knowledge, attitude, and practices of food industry workers in Selangor. The results will be reported and presented in international peer-reviewed journals, conferences, and other platforms. In addition, the TRIMOSH programme will be offered at the national level by the relevant authorities for the benefit of food industry workers.
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Mansel, R. E., et F. McNeill. « Quality assurance in surgical trials of new techniques ». Journal of Clinical Oncology 24, no 18_suppl (20 juin 2006) : 10584. http://dx.doi.org/10.1200/jco.2006.24.18_suppl.10584.

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10584 Most surgical trials include quality assurance for data and documentation, but the variable of surgical performance is often ignored, even when new techniques form one arm of the trial. Recent trials of sentinel node biopsy (NSABP-B32, ALMANAC, and AMAROS) have have attempted to control this variable by pre randomisation audit of surgical performance, but logistics and cost have limited this approach. The B-32 and ALMANAC trials did show that defined and validated pre trial audits produced high rates for localisation of the sentinel node (>95%) and false negative rates of <10%. However these results from motivated trial surgeons/teams may not be reproduced when the techniques are rolled out for general use. In the UK participation in the NEW START national training programme has been endorsed by the Health Department as evidence of satisfactory training in sentinel node biopsy. Surgeons and their teams attend a standardised theory session backed up with detailed training material on DVD. Then a training team visits with the surgical team and supervises the first 5 procedures performed by the surgeon in his own OR, after which a further 25 procedures with completion ALND are performed. All these data are evaluated prospectively centrally. A performance standard of >90% localisation rate and <10% false negative was set prospectively to determine if the surgeon is eligible for certification. The programme is currently achieving 98% localisation and <5% false negative rates in surgeons who have never performed the procedure previously, and 50% of breast surgeons in England have attended the theoretical module of the training. These data suggest that surgical trials involving new techniques should be preceeded by training and individual surgeon audit prior to randomising patients. Abbreviations OR = Operating Room ALND = Axillary Lymph Node Dissection. No significant financial relationships to disclose.
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Bendig, Eileen, Natalie Bauereiss, Andreas Schmitt, Patrick Albus et Harald Baumeister. « ACTonDiabetes—a guided psychological internet intervention based on Acceptance and Commitment Therapy (ACT) for adults living with type 1 or 2 diabetes : results of a randomised controlled feasibility trial ». BMJ Open 11, no 7 (juillet 2021) : e049238. http://dx.doi.org/10.1136/bmjopen-2021-049238.

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ObjectivesThis two-group randomised controlled trial evaluates the feasibility of an Acceptance and Commitment Therapy (ACT)-based internet intervention for diabetes distress in people with diabetes type 1 or type 2. Participants were assigned to a guided self-help intervention (EG) or waitlist control group (CG).SettingRecruitment took place following an open recruitment strategy including different diabetes centres, self-help groups and social media platforms.ParticipantsEligibility criteria comprised being 18 years of age or older, self-reported diagnosis of type 1 or type 2 diabetes, internet access, sufficient German language skills and written informed consent.InterventionACTonDiabetes is an internet-based and mobile-based intervention and comprises an introduction and seven modules (one module per week, processing time about 45–60 min). Intervention contents are based on ACT.Primary and secondary outcome measuresParticipants were assessed before and 8 weeks after randomisation. Primary outcome was feasibility (trial recruitment, acceptability). Potential group differences in diabetes distress and other outcomes at follow-up were analysed using linear regression models with baseline values as predictors. All analyses were based on an intention-to-treat principle, potential negative effects were analysed on per-protocol basis.ResultsFrom October 2017 to April 2018, N=42 people with diabetes consented and were randomised (EG n=21, CG n=21). Forty-three per cent of the EG completed all treatment modules within 8 weeks. Across modules, formative user feedback revealed that contents could be optimised regarding comprehensibility (34%), individualisation (20%) and text amount (21%). Overall, 57% of participants dropped out prior to full treatment completion. There were reductions of diabetes distress in the EG (d=0.65, p=0.042).ConclusionsModifications of the intervention content according to the user feedback will be performed to further improve acceptability. Mechanisms to foster intervention adherence should be considered for lowering the attrition rate. ACTonDiabetes is feasible for the implementation in a confirmatory trial.Trial registration numberWHO International Clinical Trials Registry Platform via the German Clinical Trials Register (DRKS) (DRKS00013193).
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Benelmouloud, O., et M. Benabbas. « Difference effect between the psychotherapeutic and chemotherapeutic treatment in treating the panic disorder ». European Psychiatry 30, S2 (novembre 2015) : S160—S161. http://dx.doi.org/10.1016/j.eurpsy.2015.09.324.

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ObjectivesThe use of CBT remains the recent techniques in Algeria and its introduction in the therapeutic arsenal field; already insufficient, finds resistances from the part of some practitioners. It is about the study showing the interest of cognitive and behavioural treatment in the panic disorder with agoraphobia.MethodologyIt is about the comparative study of the two types of the population presenting the diagnosis of a panic disorder with agoraphobia. The first group will be treated by antidepressors and the others by the cognitive behavioural treatment. The first population estimated to 50 patients receive only the antidepressors (anafranil) and the other of 50 patients receive the technique of cognitive and behavioural treatment. The two populations will be selected according to the randomisation principle. The study duration is of 3 months and the assessment is done at a day 0, 7, 14, 30 and 90 according to Cottraux anxiety scale and file automatic thought of Beek. The data (given in formation) of scales of two groups will be compared before the first day and the end of the medical care. This comparison will be done by statistical inductive tools for each group 5 to determine if it has a therapeutic effects or not) and between two groups to determine if the psychotherapic access (approach) possess equal therapeutic effects better than chemotherapy.ConclusionThe CBT widely finds its place in Algeria because it offers others characteristics: less onerous, limited in time, easy to practise, variability of techniques. The contribution of the patient in his therapeutic project with an active way. All the patients can be benefited whatever is their associeted organic defects, in reverse the medicines or the indesirable effects and the contra-indications limit its utilization. In Algeria, the practice of this structured psychotherapy is rare and it will be wished that short cycles of formation must be prodigal for the treated personal with psychiatry (nurses, psychologists, students, psychiatrists and general practitioners). To think of introducing a specialized psychotherapy courses for the medical students at the end of the cycle in frame of medical psychology module.
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Tapley, Amanda, Parker Magin, Mieke Van Driel, Billie Bonevski, Elizabeth Holliday, Jean Ball, Andrew Davey et al. « GP registrars' deprescribing in older patients : a non-randomised controlled study. » Health Education in Practice : Journal of Research for Professional Learning 7, no 1 (13 mars 2024) : 1–21. http://dx.doi.org/10.33966/hepj.7.1.17351.

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Purpose: To evaluate the effect of a multi-component educational program aimed at improving general practitioner (GP) trainees’ (registrars') deprescribing in patients 65 years and over. The hypothesis was that an educational program would increase registrars' deprescribing of potentially inappropriate medicines (PIMs) in older patients, relative to a control group, six months post-education. Design: This was a pragmatic, non-randomised, non-equivalent control group design nested within an ongoing cohort study of registrars' practice (the ReCEnT study). The program consisted of an online module, face-to-face sessions for registrars, webinars for their supervisors, and facilitation of the registrar–supervisor dyad, including case-based discussions of deprescribing in teaching meetings. The program was underpinned by the Behaviour Change Wheel framework and delivered to registrars of a single registrar educational/training organisation (other educational/training organisations served as controls). Primary outcome measures were deprescribing any medicines and deprescribing medicines categorised as PIMs. Secondary outcomes were deprescribing of medications taken for three months or more and dose reduction with a view to deprescribing (cessation). Findings: Data from 779 education-receiving registrars and 438 control registrars were analysed. Intervention group registrars showed no significant increase in deprescribing of any medication compared to controls (interaction aOR 1.00 (95%CI 0.69, 1.46) or of PIMs (aOR 1.29 (95%CI 0.74, 2.24), or significant changes in secondary outcomes. Research implications: Despite no differences in prescribing, in this analysis, six months post-intervention, aspects of the findings suggest extended observation and further evaluation may be indicated. Practical implications: The continuation of education for registrars around deprescribing of PIMs is essential. Further investigation is required to assess the effectiveness and efficiency of the behaviour change approach adopted in this study. Originality/value: The multi-component behaviour change theory-based approach is novel for this educational setting, and this is an initial step in evaluating the approach. Limitations: The major limitation is that randomisation in the study design was not practicable.
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Burnett, Alan K., Robert K. Hills, David Grimwade, Anthony H. Goldstone, Ann Hunter, Don Milligan, Archie G. Prentice, Nigel H. Russell et Keith Wheatley. « Idarubicin and ATRA Is as Effective as MRC Chemotherapy in Patients with Acute Promyelocytic Leukaemia with Lower Toxicity and Resource Usage : Preliminary Results of the MRC AML15 Trial. » Blood 110, no 11 (16 novembre 2007) : 589. http://dx.doi.org/10.1182/blood.v110.11.589.589.

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Abstract The UK MRC AML12 Trial in Acute Promyelocytic Leukaemia was conducted between 1994 and 2002 and involved the simultaneous administration of ATRA with standard chemotherapy (Daunorubicin/Etoposide/Ara-C) until complete remission. This approach resulted in an overall survival at 5 years of 80% for patients given long ATRA; however it was associated with prolonged periods of neutropenia, days on antibiotics and hospitalisation. In the successor trial, AML15, which recruited 291 patients between May 2002 and June 2007 from 90 treatment centres, the same treatment was compared with the Idarubicin/ATRA approach developed by the Spanish PETHEMA Group. Patients under 60 years of age were randomised to receive either the MRC Arm (four treatment courses ADE/ADE/MACE and MidAC with ATRA given for the first 60 days of treatment) or the Spanish Arm (two courses of Idarubicin/ATRA followed by two courses of Mitoxantrone/ATRA, and then 18 months of maintenance. In course 3 of each arm patients are randomised to receive, or not, Gemtuzumab Ozogamicin (GO) on day 1. Since it was considered unlikely that sufficient patients would be available to demonstrate any effectiveness difference the primary endpoints were toxicity, neutropenic days, days on antibiotics, hospitalisation, supportive care requirements and Quality of Life which was measured at baseline, and 3, 6, 12 and 24 months from entry using the EORTC QLQ30, plus leukaemia module, and Hospital Anxiety and Depression Score. Results: No difference in CR was seen (91% MRC vs 93% Spanish; OR 0.73, 95%CI 0.30–1.77, p=0.5); 10 vs 8 patients died during induction and 1 patient in each arm had resistant disease. Five (MRC) vs 6 (Spanish) patients have relapsed. More patients (n=11) in the MRC arm died in CR than in the Spanish arm (n=2) (p=0.009). Overall survival, with a median follow up of 24 months, was not significantly different (85% Spanish vs 81% MRC at 4 years; HR 0.57 95% CI 0.29–1.11, p=0.10). The MRC treatment was significantly more myelosuppressive which resulted in significantly greater need for blood product support, days on antibiotics and hospitalisation, particularly in the second course (p<0.0001). The randomisation to GO in course 3 continues. Preliminary analysis of the quality of life data suggests a benefit for Spanish therapy during the induction/consolidation phase, but with some adverse impact during the maintenance phase. Conclusion: We confirm that the Spanish combination of Idarubicin and ATRA is as effective as the more intensive MRC chemotherapy based approach. The extra chemotherapy involved in the MRC approach increased supportive care requirements and resulted in an excess of deaths in CR and an adverse impact on quality of life. We will now compare the Idarubicin/ ATRA treatment with the chemotherapy free combination of ATRA/ Arsenic Trioxide.
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Blair, Joanne, Andrew McKay, Colin Ridyard, Keith Thornborough, Emma Bedson, Matthew Peak, Mohammed Didi et al. « Continuous subcutaneous insulin infusion versus multiple daily injections in children and young people at diagnosis of type 1 diabetes : the SCIPI RCT ». Health Technology Assessment 22, no 42 (août 2018) : 1–112. http://dx.doi.org/10.3310/hta22420.

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Background The risk of developing long-term complications of type 1 diabetes (T1D) is related to glycaemic control and is reduced by the use of intensive insulin treatment regimens: multiple daily injections (MDI) (≥ 4) and continuous subcutaneous insulin infusion (CSII). Despite a lack of evidence that the more expensive treatment with CSII is superior to MDI, both treatments are used widely within the NHS. Objectives (1) To compare glycaemic control during treatment with CSII and MDI and (2) to determine safety and cost-effectiveness of the treatment, and quality of life (QoL) of the patients. Design A pragmatic, open-label randomised controlled trial with an internal pilot and 12-month follow-up with 1 : 1 web-based block randomisation stratified by age and centre. Setting Fifteen diabetes clinics in hospitals in England and Wales. Participants Patients aged 7 months to 15 years. Interventions Continuous subsutaneous insulin infusion or MDI initiated within 14 days of diagnosis of T1D. Data sources Data were collected at baseline and at 3, 6, 9 and 12 months using paper forms and were entered centrally. Data from glucometers and CSII were downloaded. The Health Utilities Index Mark 2 was completed at each visit and the Pediatric Quality of Life Inventory (PedsQL, diabetes module) was completed at 6 and 12 months. Costs were estimated from hospital patient administration system data. Outcomes The primary outcome was glycosylated haemoglobin (HbA1c) concentration at 12 months. The secondary outcomes were (1) HbA1c concentrations of < 48 mmol/mol, (2) severe hypoglycaemia, (3) diabetic ketoacidosis (DKA), (4) T1D- or treatment-related adverse events (AEs), (5) change in body mass index and height standard deviation score, (6) insulin requirements, (7) QoL and (8) partial remission rate. The economic outcome was the incremental cost per quality-adjusted life-year (QALY) gained. Results A total of 293 participants, with a median age of 9.8 years (minimum 0.7 years, maximum 16 years), were randomised (CSII, n = 149; MDI, n = 144) between May 2011 and January 2015. Primary outcome data were available for 97% of participants (CSII, n = 143; MDI, n = 142). At 12 months, age-adjusted least mean squares HbA1c concentrations were comparable between groups: CSII, 60.9 mmol/mol [95% confidence interval (CI) 58.5 to 63.3 mmol/mol]; MDI, 58.5 mmol/mol (95% CI 56.1 to 60.9 mmol/mol); and the difference of CSII – MDI, 2.4 mmol/mol (95% CI –0.4 to 5.3 mmol/mol). For HbA1c concentrations of < 48 mmol/mol (CSII, 22/143 participants; MDI, 29/142 participants), the relative risk was 0.75 (95% CI 0.46 to 1.25), and for partial remission rates (CSII, 21/86 participants; MDI, 21/64), the relative risk was 0.74 (95% CI 0.45 to 1.24). The incidences of severe hypoglycaemia (CSII, 6/144; MDI, 2/149 participants) and DKA (CSII, 2/144 participants; MDI, 0/149 participants) were low. In total, 68 AEs (14 serious) were reported during CSII treatment and 25 AEs (eight serious) were reported during MDI treatment. Growth outcomes did not differ. The reported insulin use was higher with CSII (mean difference 0.1 unit/kg/day, 95% CI 0.0 to 0.2 unit/kg/day; p = 0.01). QoL was slightly higher for those randomised to CSII. From a NHS perspective, CSII was more expensive than MDI mean total cost (£1863, 95% CI £1620 to £2137) with no additional QALY gains (–0.006 QALYs, 95% CI –0.031 to 0.018 QALYs). Limitations Generalisability beyond 12 months is uncertain. Conclusions No clinical benefit of CSII over MDI was identified. CSII is not a cost-effective treatment in patients representative of the study population. Future work Longer-term follow-up is required to determine if clinical outcomes diverge after 1 year. A qualitative exploration of patient and professional experiences of MDI and CSII should be considered. Trial registration Current Controlled Trials ISRCTN29255275 and EudraCT 2010-023792-25. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 42. See the NIHR Journals Library website for further project information. The cost of insulin pumps and consumables supplied by F. Hoffman-La Roche AG (Basel, Switzerland) for the purpose of the study were subject to a 25% discount on standard NHS costs.
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Thèses sur le sujet "Moduli randomisation"

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Courtois, Jérôme. « Leak study of cryptosystem implementations in randomized RNS arithmetic ». Electronic Thesis or Diss., Sorbonne université, 2020. http://www.theses.fr/2020SORUS290.

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On parlera d'analyse forte pour une analyse qui permet de retrouver la clef d'un système cryptographique et d'une analyse faible dans le cas où on élimine des clefs candidates. Le but de cette thèse est essentiellement la compréhension du comportement de l'aléa des distances de Hamming produites par un système cryptographique de type ECC (Elliptic Curve for Cryptography) quand on utilise une représentation RNS (Residue Number System) avec la méthode des moduli aléatoires. Le Chapitre 2 introduit les différentes notions nécessaires à la compréhension de ce document. Il introduit brièvement l'algorithme de multiplication modulaire (Algorithme de Montgomery pour RNS) qui a inspiré la méthode des moduli aléatoires. Puis il décrit l'algorithme qui génère les séquences de distances de Hamming nécessaires à notre analyse. Ensuite il montre quel niveau de résistance apporte la méthode des moduli aléatoires contre différentes attaques classiques comme DPA (Diferential Power Analysis), CPA (Correlation Power Analysis), DPA du second ordre et MIA (Mutual Information Analysis). On apporte une compréhension de la distribution des distances de Hamming considérées comme des variables aléatoires. Suite à cela, on ajoute l'hypothèse gaussienne sur les distances de Hamming. On utilise alors le MLE (Maximum Likelihood Estimator) et une analyse forte comme pour faire des Template Attacks pour avoir une compréhension fine du niveau d'aléa apporté par la méthode des moduli aléatoires. Le Chapitre 3 est une suite naturelle des conclusions apportées par le Chapitre 2 sur l'hypothèse gaussienne. Si des attaques sont possibles avec le MLE, c'est qu'il existe sans doute des relations fortes entre les distances de Hamming considérées comme des variables aléatoires. La Section 3.2 cherche à quantifier ce niveau de dépendance des distances de Hamming. Ensuite, en restant dans l'hypothèse gaussienne, on remarquera qu'il est possible de construire une type de DPA qu'on a appelé DPA square reposant sur la covariance au lieu de la moyenne comme dans la DPA classique. Mais cela reste très gourmand en traces d'observation d'autant que dans de nombreux protocoles utilisant une ECC, on utilise une clef qu'une seule fois. La Section 3.4 s'efforce de montrer qu'il existe de l'information sur peu de traces de distances de Hamming malgré la randomisation des moduli. Pour cela, on fait un MLE par un conditionnement sur l'une des distances de Hamming avec une analyse faible. Le dernier Chapitre 4 commence par introduire brièvement les choix algorithmiques qui ont été faits pour résoudre les problèmes d'inversion de matrices de covariance (symétriques définies positives) de la Section 3.2 et l'analyse des relations fortes entre les Hamming dans la Section 3.2. On utilise ici des outils de Graphics Processing Unit (GPU) sur un très grand nombre de matrices de petites tailles. On parlera de Batch Computing. La méthode LDLt présentée au début de ce chapitre s'est avérée insuffisante pour résoudre complètement le problème du MLE conditionné présenté dans la Section 3.4. On présente le travail sur l'amélioration d'un code de diagonalisation de matrice tridiagonale utilisant le principe de Diviser pour Régner (Divide & Conquer) développé par Lokmane Abbas-Turki et Stéphane Graillat. On présente une généralisation de ce code, des optimisations en temps de calcul et une amélioration de la robustesse des calculs en simple précision pour des matrices de taille inférieure à 32
We will speak of strong analysis for an analysis which makes it possible to find the key to a cryptographic system. We define a weak analysis in the case where candidate keys are eliminated. The goal of this thesis is to understand the behavior of the random of Hamming distances produced by an ECC (Elliptic Curve for Cryptography) cryptographic system when using a RNS (Residue Number System) representation with the random moduli method. Chapter 2 introduces the different concepts for understanding this document. He brieflyintroducesthemodularmultiplicationalgorithm(MontgomeryalgorithmforRNS) which inspired the method of random moduli. Then it describes the algorithm which generatestheHammingdistancesequencesnecessaryforouranalysis. Thenitshowswhat level of resistance brings the method of random moduli against different classic attacks like DPA (Diferrential Power Analysis), CPA (Correlation Power Analysis), DPA of the second order and MIA (Mutual Information Analysis). We provide an understanding of the distribution of Hamming distances considered to be random variables. Following this, we add the Gaussian hypothesis on Hamming distances. We use MLE (Maximum Likelihood Estimator) and a strong analysis as to make Template Attacks to have a fine understanding of the level of random brought by the method of random moduli. The last Chapter 4 begins by briefly introducing the algorithmic choices which have been made to solve the problems of inversion of covariance matrices (symmetric definite positive) of Section 2.5 and the analysis of strong relationships between Hamming in Section 3.2. We use here Graphics Processing Unit (GPU) tools on a very large number of small size matrices. We talk about Batch Computing. The LDLt method presented at the beginning of this chapter proved to be insufficient to completely solve the problem of conditioned MLE presented in Section 3.4. We present work on the improvement of a diagonalization code of a tridiagonal matrix using the principle of Divide & Conquer developed by Lokmane Abbas-Turki and Stéphane Graillat. We present a generalization of this code, optimizations in computation time and an improvement of the accuracy of computations in simple precision for matrices of size lower than 32
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Mlynski, David. « On the multivariate analysis of animal networks ». Thesis, University of Bath, 2016. https://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.690727.

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From the individual to species level, it is common for animals to have connections with one another. These connections can exist in a variety of forms; from the social relationships within an animal society, to hybridisation between species. The structure of these connections in animal systems can be depicted using networks, often revealing non-trivial structure which can be biologically informative. Understanding the factors which drive the structure of animal networks can help us understand the costs and benefits of forming and maintaining relationships. Multivariate modelling provides a means to evaluate the relative contributions of a set of explanatory factors to a response variable. However, conventional modelling approaches use statistical tests which are unsuitable for the dependencies inherent in network and relational data. A solution to this problem is to use specialised models developed in the social sciences, which have a long history in modelling human social networks. Taking predictive multivariate models from the social sciences and applying them to animal networks is attractive given that current analytical approaches are predominantly descriptive. However, these models were developed for human social networks, where participants can self-identify relationships. In contrast, relationships between animals have to be inferred through observations of associations or interactions, which can introduce sampling bias and uncertainty to the data. Without appropriate care, these issues could lead us to make incorrect or overconfident conclusions about our data. In this thesis, we use an established network model, the multiple regression quadratic assignment procedure (MRQAP), and propose approaches to facilitate the application of this model in animal network studies. Through demonstrating these approaches on three animal systems, we make new biological findings and highlight the importance of considering data-sampling issues when analysing networks. Additionally, our approaches have wider applications to animal network studies where relationships are inferred through observing dyadic interactions.
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Livres sur le sujet "Moduli randomisation"

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Elwood, Mark. Confounding. Oxford University Press, 2017. http://dx.doi.org/10.1093/med/9780199682898.003.0007.

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This chapter gives the definition of confounding, a central issue in epidemiology and its dependence on two associations, with exposure and with outcome. It explains confounding in trials, cohort and case-control studies, and Simpson’s paradox. It explains the five methods of controlling confounding: restriction, randomisation, stratification, matching and multivariate methods. For randomised trials, the limits of randomisation, residual confounding, pre-stratification, intention-to-treat, management and explanatory trials, pragmatic trials are explained. It shows the Mantel–Haenszel risk ratio or odds ratio, direct and indirect standardisation, and effect modification. Frequency and individual matching, their value and limitations, over matching, confounding by indication, and calculation of matched odds ratio are shown. It explains multivariate methods, including linear, logistic, Poisson, and Cox’s proportionate hazards models, including the relationship between coefficients and odds ratios, dummy variables, conditional methods, and propensity scores.
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Actes de conférences sur le sujet "Moduli randomisation"

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Feklisov, Egor, Mihail Zinderenko et Vladimir Frolov. « Procedural interior generation for artificial intelligence training and computer graphics ». Dans International Conference "Computing for Physics and Technology - CPT2020". Bryansk State Technical University, 2020. http://dx.doi.org/10.30987/conferencearticle_5fce2771c14fa7.77481925.

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Since the creation of computers, there has been a lingering problem of data storing and creation for various tasks. In terms of computer graphics and video games, there has been a constant need in assets. Although nowadays the issue of space is not one of the developers' prime concerns, the need in being able to automate asset creation is still relevant. The graphical fidelity, that the modern audiences and applications demand requires a lot of work on the artists' and designers' front, which costs a lot. The automatic generation of 3D scenes is of critical importance in the tasks of Artificial Intelligent (AI) robotics training, where the amount of generated data during training cannot even be viewed by a single person due to the large amount of data needed for machine learning algorithms. A completely separate, but nevertheless necessary task for an integrated solution, is furniture generation and placement, material and lighting randomisation. In this paper we propose interior generator for computer graphics and robotics learning applications. The suggested framework is able to generate and render interiors with furniture at photo-realistic quality. We combined the existing algorithms for generating plans and arranging interiors and then finally add material and lighting randomization. Our solution contains semantic database of 3D models and materials, which allows generator to get realistic scenes with randomization and per-pixel mask for training detection and segmentation algorithms.
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Yeter, Baran, Yordan Garbatov et Carlos Guedes Soares. « Structural Health Monitoring Data Analysis for Ageing Fixed Offshore Wind Turbine Structures ». Dans ASME 2021 40th International Conference on Ocean, Offshore and Arctic Engineering. American Society of Mechanical Engineers, 2021. http://dx.doi.org/10.1115/omae2021-63007.

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Abstract The objective of the present study is to perform a systematic data analysis of structural health monitoring data for ageing fixed offshore wind turbine support structures. The life-cycle extension of the first offshore wind farms is under serious consideration since the support structures are still in a condition to be used further. Big data analytics and machine learning techniques can aid to extract useful information from the monitoring data collected during the service life and build models for future predictions of an optimal life-extension. To this end, it is aimed to analyse the big data provided by embedded control systems and non-destructive inspections of ageing offshore wind turbine support structures using pre-processing techniques, including denoising, detrending, and filtering to remove the noise of different nature and seasonality as well as to detect the signal-specific contents affecting the structural integrity in the time and frequency domain. The effectiveness of the Welch method is investigated in terms of dealing with noisy signals in the frequency domain. Besides, the principal component analysis is carried out to reduce the dimensionality of the data and to select the most significant features that are responsible for most of the variance in the structural health monitoring data. Moreover, nonparametric statistical methods are used to test whether the data before noise being added and the data after cleansing the added noise came from the population with the same distribution. Further, permutation (randomisation) testing is performed to predicate that the results of the nonparametric test are statistically significant. The outcome of this study provides refined evidence that enables to feed the condition monitoring data into the training of the deep neural network to be able to discriminate different structural conditions.
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