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Association of expedited review programmes with postmarketing safety events of new drugs approved by the US food and drug administration between 2007 and 2017
Published 2022-07-01“…Objective To explore the associations between the risks of postmarketing safety events of new drugs and the four expedited programmes of priority review, accelerated approval, fast track and breakthrough therapy established by the US Food and Drug Administration (FDA); and to investigate whether multiple uses of expedited programmes, and the combinations of expedited programmes with orphan designation, were relevant to different safety profiles.Design Cohort study.Setting USA.Participants All new drugs approved by the FDA between 1 January 2007 and 31 December 2017, followed up until 10 April 2021.Outcome measures Safety events included safety-related withdrawal, new boxed warning, drug safety communication, postapproval risk evaluation mitigation strategy and safety-related labelling changes. …”
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Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme
Published 2020-10-01“…IRs remained consistent with previous reports from the tofacitinib RA clinical development programme, and stable over time.Trial registration numbers NCT01262118; NCT01484561; NCT00147498; NCT00413660; NCT00550446; NCT00603512; NCT00687193; NCT01164579; NCT00976599; NCT01059864; NCT01359150; NCT02147587; NCT00960440; NCT00847613; NCT00814307; NCT00856544; NCT00853385; NCT01039688; NCT02187055; NCT00413699; NCT00661661.For summary of phase I, phase II, phase III, phase IIIb/IV and LTE studies included in the integrated safety analysis, see online supplemental table 1.…”
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Integrating WHO thinking healthy programme for maternal mental health into routine antenatal care in China: a randomized-controlled pilot trial
Published 2025-01-01Subjects: Get full text
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Recruitment and retention of participants in randomised controlled trials: a review of trials funded and published by the United Kingdom Health Technology Assessment Programme
Published 2017-03-01“…Many trials fail to reach their planned sample size within the envisaged trial timescale and trial funding envelope.Objectives To review the consent, recruitment and retention rates for single and multicentre randomised control trials funded and published by the UK's National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme.Data sources and study selection HTA reports of individually randomised single or multicentre RCTs published from the start of 2004 to the end of April 2016 were reviewed.Data extraction Information was extracted, relating to the trial characteristics, sample size, recruitment and retention by two independent reviewers.Main outcome measures Target sample size and whether it was achieved; recruitment rates (number of participants recruited per centre per month) and retention rates (randomised participants retained and assessed with valid primary outcome data).Results This review identified 151 individually RCTs from 787 NIHR HTA reports. …”
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Additional Language Learning in Montessori settings: insights from the implementation process of a Second Language Programme in a Scottish Montessori school
Published 2024-12-01“…Language Learning programmes in Montessori settings need to be considered from the perspective of the child, the teachers, the parents and the school as they all integrate to create tailor made bilingual programmes that respond to the context, characteristic and resources of the school. …”
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Impact of lay health worker programmes on the health outcomes of mother-child pairs of HIV exposed children in Africa: A scoping review.
Published 2019-01-01“…<h4>Objectives</h4>To examine evidence of the roles and impact of lay health worker programmes focusing on Women Living with HIV (WLH) and their HIV-exposed infants (HEIs).…”
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Effectiveness of an intensive outpatient treatment programme combining prolonged exposure and EMDR therapy for adolescents and young adults with PTSD in a naturalistic setting
Published 2025-12-01“…Looking at the results from adult treatments, short, intensive, outpatient treatment programmes may offer a promising alternative, but it has yet to be tested in this young population.Objective: To assess the results of a six-day intensive outpatient trauma-focused treatment programme for young individuals (12-25 years) with PTSD. …”
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What are the expectations and experiences of a GMH research programme delivered in Bosnia-Herzegovina, Colombia and Uganda?...
Published 2022-06-01“…Previous evaluations of such programmes have identified areas for improvement but consisted only of retrospective experiences. …”
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Documenting and Reporting Implementation Strategies of Vaccination Efforts (DRIVE) framework for fostering systems learning to enhance cross-context replication in immunization programmes
Published 2025-01-01“…Abstract There is an urgent need to transform immunization programmes into agile learning systems where implementation strategies that are effective within a particular setting can be systematically and rapidly incorporated into policies and practice in other places to drive performance improvement. …”
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Factors influencing adherence to home based pulmonary rehabilitation programme by high risk patients awaiting lung surgery: mixed methods study
Published 2024-12-01“…This study aimed to investigate the level of adherence to a preoperative HPR programme in high risk patients awaiting lung surgery, and factors influencing adherence.Design A mixed methods explanatory sequential design consisting of a quantitative questionnaire survey and a qualitative interview study.Setting The study was conducted at a tertiary hospital in Chongqing, China.Participants 186 high risk patients awaiting lung surgery were enrolled in the preoperative HPR programme. …”
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La programmation cinématographique parisienne au cours de la saison 1929/1930 : vers une appréhension des habitudes spectatorielles
Published 2012-04-01“…The observation of the programme will probably take a first step towards spectator habits. …”
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Cardiovascular events observed among patients in the etrasimod clinical programme: an integrated safety analysis of patients with moderately to severely active ulcerative colitis
Published 2025-01-01“…One event each of CAD and CVD occurred in two patients receiving etrasimod.Conclusions In the etrasimod UC clinical programme, IRs of cardiovascular-related TEAEs and other cardiovascular events were low. …”
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Design and validation of a programmable dual-tunnel soft pneumatic origami actuator with a large maximum shrinkage rate for reciprocating motion
Published 2025-01-01“…The inner tunnel is constructed by the origami mechanism chamber, and the outer tunnel is formed by the origami mechanism in conjunction with the outer soft skin. A programmable design method for the proposed actuator is presented, based on its geometric parameter model and stiffness model. …”
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Barriers and facilitators to implementation of a home-based cardiac rehabilitation programme for patients with heart failure in the NHS: a mixed-methods study
Published 2022-07-01“…REACH-HF is an effective and cost-effective 12-week home-based cardiac rehabilitation programme for patients with heart failure.Setting/participants In 2019, four early adopter ‘Beacon Sites’ were set up to deliver REACH-HF to 200 patients. …”
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