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Clinical & Research · page 28

New research and findings from open-access journals and the U.S. research agencies.

MedCity News · Jul 10, 2026

Glaucoma Drug Fails Trial, But Bausch + Lomb Sees Opportunity in Another Eye Disease

A Bausch + Lomb drug from a 2025 acquisition missed primary and secondary goals of a Phase 2 test in glaucoma. Bausch now plans to develop this drug for geographic atrophy, aiming to succeed where Allergan, now an AbbVie subsidiary, fell short in the clinic. The post Glaucoma Drug Fails Trial, But Bausch + Lomb Sees Opportunity in Another Eye Disease appeared first on MedCity News .

PLOS Medicine · Jul 10, 2026

Compression therapies for venous leg ulcers: The VENous Ulcer Study 6 (VenUS 6), an open, multicentre, randomised clinical trial

by Catherine Arundel, Charlie Welch, Luke Strachan, Charlie Peck, Ross Atkinson, Una Adderley, Ian Chetter, Nicky Cullum, Tom Davill, Jane Griffiths, Catherine Hewitt, Charlotte Hirst, Katherine Jones, Maartje Kletter, Julie Mullings, Han Phung, Gareth Roberts, Pedro Saramago, Brigid Smart, Marta Soares, Philip Stather, Nikki Stubbs, Jude Watson, Sabeen Zahra, Jo Dumville Background Strong compression is a recommended first line venous leg ulcer treatment. With limited research comparing the clinical effectiveness of compression wraps (CW) and two-layer compression bandage treatments with…

BMJ Open · Jul 10, 2026

Knowledge, attitudes and practices regarding diabetic nephropathy among patients with diabetes in Shanghai, China: a cross-sectional study

Objectives This study aims to investigate the knowledge, attitudes and practices (KAP) regarding diabetic nephropathy among patients with diabetes. Design A cross-sectional survey was conducted. Setting The survey was administered in a clinical setting. Participants A total of 410 patients with diabetes completed the questionnaires, with 215 (52.44%) identified as female and 262 (63.9%) not diagnosed with diabetic nephropathy. Interventions Participants provided demographic information and answered questions assessing their KAP through a structured questionnaire. Primary and secondary outcome…

BMJ Open · Jul 10, 2026

Psychometric properties of the Generalised Anxiety Disorder-7 (GAD-7) screening tool in people living with HIV: the Afaan Oromoo version

Objective The aim of the study was to assess the psychometric properties of the Afaan Oromoo version of Generalised Anxiety Disorder-7 (GAD-7) scale among people living with HIV. Design A hospital-based cross-sectional study. Setting The study was conducted at a tertiary-level antiretroviral therapy clinic. Participants The study included 163 people living with HIV. Primary outcome measures The GAD-7 scale was evaluated against the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition diagnostic criteria for GAD as the gold standard. Result A total of 163 participants were…

BMJ Open · Jul 10, 2026

Knowledge, attitudes and practices regarding immediate breast reconstruction after mastectomy: a cross-sectional study in Jordan

Objectives This study aimed to evaluate the knowledge, attitudes and practices (KAP) of Jordanian women regarding post-mastectomy breast reconstruction (PMBR), and to recognise key sociodemographic factors influencing these outcomes. Design A descriptive cross-sectional study. Setting Community-based settings across Jordan, representing a general population sample. Participants A total of 752 adult women were enrolled in the study. Eligible participants were women aged 18 years or older who were living in Jordan. Recruitment took place across a variety of community settings. Data were…

BMJ Open · Jul 10, 2026

Assessing the association of type 2 diabetes with skin health status: a study of the Northern Finland Birth Cohort 1966

Objectives There is evidence to suggest that alterations in skin health often co-occur with type 2 diabetes (T2D). However, the underlying mechanisms remain unclear. Despite their clinical relevance, skin conditions are often underdiagnosed in diabetes care. This study applied variable selection methods to identify key dermatological factors linked to T2D and examined their direct and indirect associations. Design Prospective birth cohort study. Participants This study analysed data from the Northern Finland Birth Cohort 1966, including 1906 participants (1024 women, 882 men) at ages 31 and 46…

BMJ Open · Jul 10, 2026

Building genetic healthcare together: an Australian co-production three-phase mixed-methods research protocol with people with intellectual disability

Introduction People with intellectual disability face significant barriers to accessing genetic healthcare, including during appointments. Many adults with intellectual disability are denied opportunities to discuss genetic testing that could improve their health and well-being. This study follows best practice in inclusive research, with co-researchers with intellectual disability co-leading alongside educational, disability and clinical experts to co-design and implement a respectful, accessible and inclusive national model of genetic healthcare. Methods and analysis This three-phase…

BMJ Open · Jul 10, 2026

Heart recipient outcomes following transplantation of donor hearts with impaired versus normal function: a study protocol for IMPROVED Heart, a prospective multicentre observational study

Background Cardiac transplantation remains the most effective treatment for patients with end-stage heart failure, but its use is limited by donor organ shortage. Expanding donor acceptance criteria may increase the availability of transplantable hearts. Left ventricular dysfunction due to neurogenic stunned myocardium is common among organ donors and is characterised by rapid functional and structural recovery. The IMPROVED Heart (IMPact of donor heart function on Recipient Outcomes: a prospectiVE observational study to increase the utilisation of Donor Hearts) study aims to increase the…

BMJ Open · Jul 10, 2026

Role of socioeconomic deprivation on inequities in care outcomes of haematological malignancies treated with stem cell transplant in the UK: a systematic review protocol

Introduction Stem cell transplant (SCT) is a potential cure for haematological malignancies whose outcomes are predicted to be poor on chemotherapy alone and cases difficult to treat using standard of care treatment. There is growing evidence to show that not all patients who would benefit from SCT receive it due to inequities in the treatment pathway. The role of socioeconomic deprivation on inequities in the SCT setting is unclear due to conflicting findings. We aim to synthesise the UK evidence base in this area from the point of diagnosis to transplant to guide further research and policy…

BMJ Open · Jul 10, 2026

Predicting antenatal care dropout using machine learning and describing maternal and neonatal outcomes by dropout status in Sidama Region, Ethiopia: a retrospective cohort study

Objectives We aimed to develop and validate machine-learning models to predict antenatal care (ANC) dropout and describe maternal and neonatal outcomes by ANC dropout status in a low-resource setting in Northern Sidama, Ethiopia. Design Retrospective cohort study. Setting Health facilities across four districts in Northern Sidama, Ethiopia. Participants 3855 pregnant women aged 15–49 years who initiated ANC between January 2021 and January 2025 were included, whereas women with incomplete records or those who relocated before delivery were excluded. Outcome measures The primary outcome was ANC…

BMJ Open · Jul 10, 2026

Derisking translational research in India through the Indian Council of Medical Research (ICMR) network for phase 1 clinical trials and public-private partnerships

Importance Phase 1 clinical trials fall at a critical intersection of translational research and drug development. With a high failure rate at this stage, only enterprises capable of substantial risk tolerance and heavy investment can step into translational medicine. Academic and public sector researchers in India often lack expertise in early-phase clinical trials. This, along with a lack of dedicated infrastructure, poses some unique challenges in the early-phase drug development process. In this paper, the authors explore public-private partnership (PPP) models of pharmaceutical innovation…

BMJ Open · Jul 10, 2026

Development of a machine learning-based model for predicting adverse pregnancy outcomes in women with polycystic ovary syndrome (PCOS): a retrospective observational study protocol

Introduction Polycystic ovary syndrome (PCOS) is a prevalent endocrine condition in reproductive-aged women, which is associated with adverse maternal and neonatal outcomes in pregnancy. In the present study, pregnancy complications—like gestational diabetes, preterm birth, hypertension, low birth weight and neonatal intensive care unit admission—will be predicted with high accuracy by machine learning-based prediction models. Methods and analysis There are three substudies: (1) Developing a researcher-made questionnaire by literature review, data collection from existing medical records in…

BMJ Open · Jul 10, 2026

What are the experiences, perceptions and expressed needs of adolescents living with obesity and their mothers in Indonesia? a qualitative multi-method study

Objectives This study aimed to explore the experiences, perceptions and expressed needs of adolescents living with obesity (ALOs) and their mothers. Design Data were collected through ALOs’ diary journals, short-term ethnographic fieldwork at ALOs’ schools and semi-structured individual interviews with both ALOs and their mothers. Reflexive thematic analysis was conducted using an inductive approach with two independent coders. Setting The study was conducted at one paediatric outpatient clinic at Dr Sardjito Tertiary Referral Hospital and in three selected junior and one senior high schools…

BMJ Open · Jul 10, 2026

Effects of open- versus closed-skill exercise combined with mindfulness training on inhibitory control in children with ADHD: protocol for a three-arm randomised controlled trial with fMRI

Introduction Impaired inhibitory control is a core neurocognitive deficit in children with attention deficit hyperactivity disorder (ADHD). Physical exercise and mindfulness training are each promising non-pharmacological approaches for ADHD; however, whether combining mindfulness with different exercise modalities, particularly team-based and individual-based open-skill exercise versus closed-skill exercise, yields differential effects on inhibitory control and its neural substrates remains unknown. This study aims to compare these intervention approaches in children with ADHD while exploring…

BMJ Open · Jul 10, 2026

What influences UK-practising consultant hip surgeons decision-making about implant fixation? An interview study

Objectives To explore the views of UK-based consultant hip surgeons about implant fixation choice and identify factors that inform decision-making about use of cemented, hybrid or uncemented implant fixation when performing total hip replacement in adults aged under 70 years. Design Qualitative semistructured interview study. Recruitment was through consultant participation in a national online survey. Purposive sampling was used to ensure a range of implant fixation methods in the final sample. Data were audio recorded, transcribed, anonymised and analysed inductively to generate themes…

BMJ Open · Jul 10, 2026

Plasma-activated water as a wound rinse solution in patients with diabetes-related foot ulcers in two Australian hospitals: study protocol for a phase I double-blinded, randomised controlled trial

Introduction Patients living with diabetes-related foot ulcers (DFU) often have non-healing wounds that, despite ongoing clinical management and wound debridement as standard of care, can proceed to infection and lower limb amputation. Additionally, treatment guidelines do not recommend most topical antibiotics or antiseptic treatments, limiting complements to surgical wound debridement. We present a protocol for a phase I randomised controlled trial testing the safety and efficacy of plasma-activated water as an antiseptic for preventing infection and promoting ulcer healing. Methods and…

BMJ Open · Jul 10, 2026

Complementary feeding indicators among children aged 6-23 months: a cross-sectional study assessing minimum dietary diversity, minimum acceptable diet and dietary patterns in Njombe Town Council, Tanzania

Objectives This study assessed the minimum dietary diversity (MDD), minimum meal frequency (MMF), minimum acceptable diet (MAD) and dietary patterns among children aged 6–23 months in Njombe Town Council. Design Community-based cross-sectional study. Setting This study was conducted in the Njombe Town Council, which is located in the Njombe region in the southern part of Tanzania. Participants A total of 330 caregivers of children aged 6–23 months were recruited using a multistage probability sampling technique. Data were collected from January to March 2021 using a structured questionnaire…

BMJ Open · Jul 10, 2026

Knowledge and misconceptions regarding choking and first-aid procedures among the general population in the West Bank, Palestine: a cross-sectional study

Objectives To assess the level of knowledge, attitudes and practices regarding choking first aid among the general population in the West Bank. Design A descriptive cross-sectional study. Setting West Bank, Palestine (web-based survey). Participants 454 Palestinian adults aged 18 years and above. Primary outcome measures General knowledge concerning signs of choking, misconceptions and proper first-aid manoeuvres (such as the Heimlich manoeuvre and back blows) was assessed. Analysis was performed using SPSS V.26. Results A cumulative total of 454 participants took the online survey. Although…

BMJ Open · Jul 10, 2026

Patient preferences for treatment attributes in osteoarthritis: protocol for a systematic review of stated preference studies

Introduction Osteoarthritis (OA) is a common chronic condition requiring long-term management, for which shared decision-making is increasingly recognised as an important component of care. Stated preference (SP) methods, including discrete choice experiments (DCE), conjoint analysis (CA) and best–worst scaling (BWS), are increasingly used to quantify patient preferences for treatment attributes and to inform clinical and policy decisions. However, evidence from SP studies in OA has not been comprehensively synthesised. This protocol describes a systematic review aiming to identify, appraise…

BMJ Open · Jul 10, 2026

Clinical and cost-effectiveness of oral versus intramuscular glucocorticoids in rheumatoid arthritis: protocol for a multicentre randomised controlled trial with economic evaluation and qualitative sub-study (LEADER trial)

Introduction Glucocorticoid (GC) bridging therapy is recommended in patients with rheumatoid arthritis commencing a disease-modifying anti-rheumatic drug (DMARD). It is not clear whether GC therapy is better administered intramuscularly or orally and at what dose level. The aim of the LEADER trial is to identify the most effective and safest way of using steroids in patients with uncontrolled RA who are starting a DMARD. Methods and analysis A multicentre, randomised, open-label, four-arm, parallel-group clinical trial with an internal pilot phase, economic evaluation and qualitative study of…

BMJ Open · Jul 10, 2026

Building a collaboration model between the primary and secondary mental healthcare levels to improve care for trauma-exposed children in Norway: study protocol for the NorStep Collaborate study

Introduction Childhood trauma is a public health challenge, and low-threshold interventions are important to prevent long-term problems. A stepped care approach is recommended so the intensity of care can be adjusted according to the child’s needs. This approach requires coordination and collaboration between service levels. However, interagency collaboration can be challenging. The aim of the NorStep Collaborate study is to develop and evaluate a model for collaboration between the primary and secondary mental healthcare levels in Norway. Methods and analysis NorStep Collaborate is part of an…

BMJ Open · Jul 10, 2026

Transcatheter aortic valve implantation outcomes by patient age and sex in COMPARE-TAVI 1: a cohort study

Objectives To explore the outcomes among patients treated with TAVI (transcatheter aortic valve implantation) in the COMPARE-TAVI 1 trial by age groups and sex. Design Cohort study. Setting Three Danish university hospitals. Participants Patients treated with TAVI in the COMPARE-TAVI 1 trial (N=1030), 60 (5.8%), 337 (32.7%), 592 (57.5%) and 41 (4.0%) were in the four age groups, < 70, 70–79, 80–89 and 90+ years while 414 (40.2%) and 616 (59.8%) were of female and male sex. Interventions Transfemoral TAVI with balloon-expandable valves (Sapien or Myval) performed between June 2020 and November…

BMJ Open · Jul 10, 2026

Correction for 'Hypochlorous acid testing studies: elective surgeries (Hypoclates:Elective)

Hoch Al Hessen T, Siegel N, Nadvornik MP, et al, et al Hypochlorous acid testing studies: elective surgeries (Hypoclates:Elective) BMJ Open 2026;16:e119500. doi: 10.1136/bmjopen-2026-119500 This article has been corrected since it was published online. Title change to "HYPOChLorous Acid TEsting Studies: ELECTIVE Surgeries (HYPOCLATES:ELECTIVE): hypochlorous acid vs isotonic lavage for the prevention of surgical site infections in elective visceral surgery in Germany – protocol for a sequential, quasi-experimental cohort study"

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