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  1. Safety of Empagliflozin: An Individual Participant-Level Data Meta-Analysis from Four Large Trials

    Introduction

    Empagliflozin is a sodium-glucose co-transporter-2 inhibitor used to treat type 2 diabetes (T2D) to improve glycemic control, reduce risk...

    Christoph Wanner, Hristo Iliev, ... Egon Pfarr in Advances in Therapy
    Article Open access 21 May 2024
  2. Efficacy and safety of the orthopaedic manipulation techniques of the Lin School of Lingnan Region in the treatment of adolescent idiopathic scoliosis: protocol of a participant-and-assessor-blinded randomized controlled study

    Background

    Adolescent idiopathic scoliosis (AIS) is the most common developmental spine disorder among children. It is characterized by a lateral...

    Hing Yu Hung, Wan Ching Kong, ... Kiu Lam Chung in BMC Musculoskeletal Disorders
    Article Open access 04 January 2024
  3. Centring participant experience: a realist evaluation of a menstruator-friendly facility design project in a refugee settlement, Lebanon

    Introduction

    Menstrual health in humanitarian contexts is a neglected topic. Its taboo nature presents difficulties for participants in menstrual...

    Georgia Hales, Paul Hutchings, ... Farah Salem in BMC Women's Health
    Article Open access 09 March 2024
  4. Influence of Participant Perceptions of Adherence-Related Interactions with Study/Study Team on Drug Levels: HPTN069 Analysis of Self-Reported Adherence Experiences While on Study

    Adherence to HIV pre-exposure prophylaxis (PrEP) study drug is critical for safety, tolerability, and efficacy trials, and may be affected by how...

    K. R. Amico, K. H. Mayer, ... R. Gulick in AIDS and Behavior
    Article Open access 10 November 2023
  5. Impact of Participant Characteristics on Clinical Outcomes with iGlarLixi in Type 2 Diabetes: Post Hoc Analysis of SPARTA Japan

    Introduction

    The real-world SPARTA Japan study confirmed the effectiveness and safety of the fixed-ratio combination of insulin glargine 100 U/mL plus...

    Daisuke Yabe, Munehide Matsuhisa, ... Yasuo Terauchi in Diabetes Therapy
    Article Open access 16 February 2024
  6. Overlap** research efforts in a global pandemic: a rapid systematic review of COVID-19-related individual participant data meta-analyses

    Background

    Individual participant data meta-analyses (IPD-MAs), which involve harmonising and analysing participant-level data from related studies,...

    Lauren Maxwell, Priya Shreedhar, ... Mabel Carabali in BMC Health Services Research
    Article Open access 06 July 2023
  7. Patient Experiences Completing Patient Reported Outcome Measures in Behavioral Health Within a Health Safety-Net Setting

    Measurement based care (MBC), a practice that uses patient reported outcome measures (PROMs), is not widely used in behavioral health settings and...

    Joanna Kramer, Daisy Perez, ... Amy M. Yule in Community Mental Health Journal
    Article 02 March 2024
  8. Introducing the participant-generated experience and satisfaction (PaGES) index: a novel, longitudinal mixed-methods evaluation tool

    Background

    Patient-Reported Outcomes or Experience Measures (PROMS / PREMS) are routinely used in clinical studies to assess participants’ views and...

    Andrew Symon, Kate Lightly, ... Andrew Weeks in BMC Medical Research Methodology
    Article Open access 28 September 2023
  9. Opportunities and counterintuitive challenges for decentralized clinical trials to broaden participant inclusion

    Traditional clinical trials have often failed to recruit representative participant populations. Just 5% of eligible patients participate in clinical...

    Noah Goodson, Paul Wicks, ... John Reites in npj Digital Medicine
    Article Open access 05 May 2022
  10. The optimal second-line therapy for older adults with type 2 diabetes mellitus: protocol for a systematic review and network meta-analysis using individual participant data (IPD)

    Background

    Due to increasing life expectancy, almost half of people with type 2 diabetes are aged 65 years or over worldwide. When metformin alone...

    **gya Wang, Krishnarajah Nirantharakumar, ... Malcolm James Price in Systematic Reviews
    Article Open access 13 June 2024
  11. Intravenous nicardipine for Japanese patients with acute intracerebral hemorrhage: an individual participant data analysis

    The effects of acute systolic blood pressure levels achieved with continuous intravenous administration of nicardipine for Japanese patients with...

    Kazunori Toyoda, Sohei Yoshimura, ... Kazuo Minematsu in Hypertension Research
    Article Open access 13 October 2022
  12. Retention strategies are routinely communicated to potential trial participants but often differ from what was planned in the trial protocol: an analysis of adult participant information leaflets and their corresponding protocols

    Background

    Retaining participants in randomised controlled trials (RCTs) is challenging and trial teams are often required to use strategies to ensure...

    Ellen Murphy, Katie Gillies, Frances Shiely in Trials
    Article Open access 10 June 2024
  13. Participant retention in paediatric randomised controlled trials published in six major journals 2015–2019: systematic review and meta-analysis

    Background

    The factors which influence participant retention in paediatric randomised controlled trials are under-researched. Retention may be more...

    Daisy M. Gaunt, Cat Papastavrou Brooks, ... Chris Metcalfe in Trials
    Article Open access 14 June 2023
  14. How do study design features and participant characteristics influence willingness to participate in clinical trials? Results from a choice experiment

    Background

    Research about the decision to participate in a clinical study has tended to be limited to single indications and has focused on narrow...

    Caitlin Thomas, Sarah Mulnick, ... Kevin Marsh in BMC Medical Research Methodology
    Article Open access 16 December 2022
  15. The Cure SMA Clinical Trial Experience Survey: A Study of Trial Participant Perspectives on Clinical Trial Management and Patient-Centric Management Practices

    Introduction

    Understanding clinical trial experiences can illuminate opportunities to optimize trial design and management, with potential benefits...

    Ilse S. Peterson, Allison J. Mazzella, ... Jill Jarecki in Neurology and Therapy
    Article Open access 30 May 2022
  16. Effect of Renal Impairment on Pharmacokinetics and Safety of Ensitrelvir, a SARS-CoV-2 3CL Protease Inhibitor

    Introduction

    Ensitrelvir, a novel oral inhibitor of 3C-like protease of SARS-CoV-2, shows efficacy and safety in participants with mild to moderate...

    Takayuki Katsube, Safwan Kezbor, ... Ryuji Kubota in Infectious Diseases and Therapy
    Article Open access 09 March 2024
  17. Laparoscopic versus open gastrectomy for nonmetastatic T4a gastric cancer: a meta-analysis of reconstructed individual participant data from propensity score-matched studies

    Background

    ​The applicability of laparoscopy to nonmetastatic T4a patients with gastric cancer remains unclear due to the lack of high-quality...

    Huayang Pang, Menghua Yan, ... Yunyun Zhang in World Journal of Surgical Oncology
    Article Open access 29 May 2024
  18. Efficacy and safety of eliapixant in endometriosis-associated pelvic pain: the randomized, placebo-controlled phase 2b SCHUMANN study

    Background

    The SCHUMANN study evaluated the efficacy and safety of the selective P2 × 3 antagonist eliapixant in patients with...

    Susanne Parke, Kerstin Gude, ... Fabrizio Messina in BMC Women's Health
    Article Open access 19 June 2024
  19. Characteristics Associated with Participant Attrition and Retention in a Perinatal Home Visiting Program

    Using data from the Florida Maternal, Infant, and Early Childhood Home Visiting (MIECHV) funded programs, we examined program- and participant-level...

    Rema Ramakrishnan, Virginia Holland, ... Jennifer Marshall in Prevention Science
    Article 22 January 2022
  20. Assessing the safety of physical rehabilitation in critically ill patients: a Delphi study

    Background

    Physical rehabilitation of critically ill patients is implemented to improve physical outcomes from an intensive care stay. However, before...

    Huw R. Woodbridge, Christopher J. McCarthy, ... Anthony C. Gordon in Critical Care
    Article Open access 30 April 2024
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