The effect of pregnancy vitamin D supplementation on maternal blood pressure: real-world data analysis within the MAVIDOS randomised placebo-controlled trial.

Purpose: Observational studies have suggested negative associations between maternal 25-hydroxyvitamin D (25(OH)D) status and risk of hypertensive disorders of pregnancy [pregnancy-induced hypertension (PIH) and preeclampsia (PET)]. Data from intervention studies are limited. We hypothesised that vitamin D supplementation would lower maternal blood pressure (BP) during pregnancy and reduce the incidence of hypertensive disorders of pregnancy.

Effectiveness of using implementation frameworks to facilitate the implementation of a stroke management guideline in the traditional Chinese medicine hospitals in China: protocol for a factorial randomised controlled trial.

Introduction: Traditional Chinese medicine (TCM) is commonly used alongside Western medicine for stroke management in China. However, there is significant variation in TCM practice, and the utilisation of evidence-based clinical practice guidelines is inadequate. This study aims to evaluate the effectiveness of three popular frameworks-Consolidated Framework for Implementation Research (CFIR), Theoretical Domains Framework (TDF) and Normalization Process Theory (NPT)-in improving implementation outcomes for the integrated TCM and Western medicine clinical practice guideline for stroke management.

Influence of religion and spirituality on head and neck cancer patients and their caregivers: a protocol for a scoping review.

Introduction: Head and neck cancers (HNC) are devastating, thus imposing a negative impact on the appearance of an individual as well as vital activities such as eating, swallowing, speaking, and breathing. Therefore, HNC patients undergo distress, while their caregivers become overburdened. Religion and spirituality can be helpful for patients and their caregivers from diverse cultural backgrounds to cope with cancer.

Protocol for a first-in-human feasibility study of T regulatory cells (TR004) for inflammatory bowel disease using (ex vivo) Treg expansion (TRIBUTE).

Introduction: Crohn's disease (CD) is a chronic, immune-mediated inflammatory bowel disease (IBD), presenting with symptoms of abdominal pain and bleeding from the gastrointestinal tract. There is no known cure. In vitro-expanded 'thymus-derived' regulatory T cells (tTreg) have shown promise in preclinical models of IBD, leading to interest in their use as a potential therapy in CD.

Identifying barriers and potential solutions to improve equitable access to community eye services: an exploratory sequential mixed methods study protocol.

Introduction: Access to care varies by sociodemographic group, with some groups facing higher barriers to care than others. This study will use novel methods to explore barriers and potential solutions as perceived by members of the population groups who are least able to access care. We aim to use rapid yet robust mixed methods that allow us to identify generalisable findings within each programme and testable service modifications to improve equitable access to care; delivering non-tokenistic findings within a matter of weeks.

Niraparib Maintenance Therapy in Patients with Platinum-Sensitive Recurrent Ovarian Cancer: Real-World Experience at Hospitals in Spain.

Background: The reported benefit of poly (ADP-ribose) polymerase inhibitor (PARPi) maintenance in patients with newly diagnosed and platinum (Pt)-sensitive recurrent ovarian cancer (OC) included in randomized clinical trials needs to be corroborated in a less selected population.

Objective: The aim is to increase the evidence on niraparib in a real-world setting.

Methods: This is a retrospective observational study including women with platinum-sensitive relapsed high-grade serous OC who started niraparib maintenance between August 2019 (marketing data, Spain) and May 2022.

Effect of propofol and ciprofol in patients undergoing bronchoscopy: protocol for a double-blind, randomised controlled trial.

Introduction: Propofol is a fast-acting intravenous anaesthetic widely used for sedation and anaesthesia in gastrointestinal endoscopy, bronchoscopy, and the induction/maintenance of general anaesthesia in outpatients and inpatients; however, propofol has several undesirable effects, including injection pain, which affects the physical and mental health of patients, and cardiopulmonary depression, characterised by hypotension, bradycardia and apnea, which commonly occur in clinical practice. Ciprofol (HSK3486) is a propofol analogue with good clinical safety, high potency and some advantages over propofol, including lower injection pain and haemodynamic depression in patients undergoing gastroscopy and colonoscopy. This study aims to compare the impact of equivalent effective doses of propofol and ciprofol on haemodynamic changes in patients undergoing bronchoscopy under general anaesthesia.

Association between nutritional status, daily nutrition delivery and clinical outcomes of critically ill adult patients admitted to the intensive care unit: a protocol for Isfahan multicentre prospective observational cohort ICU study (the Isfahan-ICU study).

Introduction: There is currently limited information regarding the association between the modified Nutrition Risk in Critically Ill (mNUTRIC) score, nutrition delivery and clinical outcomes in critically ill patients admitted to the intensive care unit (ICU) section.

Methods And Analysis: The Isfahan-ICU study is a multicentre, prospective observational cohort study that will be conducted on critically ill adults treated in the trauma or medical ICU sections of six hospitals to investigate whether clinical outcomes, including length of ICU stay and 30-day survival, vary by the mNUTRIC score at admission or the 7-day nutrition delivery. This paper outlines the Isfahan-ICU study protocol approved by the ethics committee of Isfahan University of Medical Sciences, Iran.

HEMA-free versus HEMA-containing adhesive systems: a systematic review.

Background: Hydrophilic monomer 2-hydroxyethyl methacrylate (HEMA)-free adhesive systems are gaining increasing popularity nowadays. Although the addition of HEMA to dental adhesives improves dentin wettability and resin diffusion into demineralized collagen fibrils, HEMA's high hydrophilicity can lead to hydrolytic degradation of the adhesive interface. Thus, HEMA-free adhesive systems have been developed.

High-intensive physical rehabilitation approach in children and adolescents with acquired brain injury during subacute phase (REHABILITY): a feasibility study protocol.

Introduction: While principles of neuroplasticity and motor learning emphasise the potential of high dosage of physical rehabilitation in children and adolescents with acquired brain injury (ABI) during the subacute phase, we lack empirical evidence to demonstrate its impact in terms of meaningful outcomes. Clinical research is needed to investigate adequate dosage of physical rehabilitation and its effects on outcomes with reliable and validated outcome measurements. In this study we will investigate the feasibility of a highly intensive physical rehabilitation intervention and outcomes with reliable and valid outcome measurements.

Acupuncture treatment of restless legs syndrome: a randomized clinical controlled study protocol based on PET-CT and fMRI.

Introduction: Restless legs syndrome (RLS) is a sensorimotor disorder of the nervous system that is mainly characterized by nighttime leg discomfort and can be accompanied by significant anxiety, depression, and other mood disorders. RLS seriously affects the quality of life. Clinical studies have confirmed that acupuncture can alleviate the clinical symptoms of RLS.

Mapping the landscape and evidence of cross-sectoral collaboration models targeting individuals referred for assessment of attention-deficit hyperactivity disorder or autism spectrum disorder: protocol for a scoping review.

Introduction: Neurodevelopmental disorders, notably attention-deficit hyperactivity disorder (ADHD) and autism spectrum disorder (ASD), present substantial challenges in mental health. Individuals referred for assessment in a psychiatric unit experience complex needs. This implies that their needs necessitate coordination across multiple sectors.

Sleep profile in patients with septo-optic-pituitary dysplasia: protocol for a prospective cohort study.

Introduction: Children with septo-optic-pituitary dysplasia (SOD) may experience a range of visual impairments and hormonal dysfunctions beyond developmental delay/intellectual disability. The literature describes sleep fragmentation, circadian rhythm disruptions and reduced sleep efficiency. These manifestations are believed to be closely linked to both structural and functional abnormalities associated with SOD, potentially disrupting the natural circadian rhythm.

Patient preferences for drug therapy in inflammatory arthritis: protocol for a living systematic review and evidence map to inform clinical practice guidelines.

Introduction: The pharmacological management of inflammatory arthritis often requires choices that involve trade-offs between benefits, risks and other attributes such as administration route, frequency and cost. This living systematic review aims to inform international clinical guidelines on inflammatory arthritis by creating an evidence map of patient preference studies concerning the trade-offs in pharmacological management of inflammatory arthritis.

Methods And Analysis: We will include published and peer-reviewed full-text studies in any language that quantitatively assess preferences of patients for the pharmacological management of inflammatory arthritis (rheumatoid arthritis, spondyloarthritis and juvenile idiopathic arthritis).

Effectiveness of a virtual reality-based sensory stimulation intervention in preventing delirium in intensive care units: a randomised-controlled trial protocol.

Introduction: Delirium is a common acute cognitive impairment characterised by confusion, disorientation and attention deficits, particularly prevalent in intensive care unit (ICU) settings. Given its significant impact on patients, caregivers and healthcare resources, preventing delirium in patients in the ICU is of paramount importance. This is the first randomised-controlled trial designed to evaluate the effects of a virtual reality-based sensory stimulation intervention on preventing delirium in ICU patients.

Short- and long-term effects of transcutaneous spinal cord stimulation on autonomic cardiovascular control and arm-crank exercise capacity in individuals with a spinal cord injury (STIMEX-SCI): study protocol.

Introduction: Individuals with higher neurological levels of spinal cord injury (SCI) at or above the sixth thoracic segment (≥T6), exhibit impaired resting cardiovascular control and responses during upper-body exercise. Over time, impaired cardiovascular control predisposes individuals to lower cardiorespiratory fitness and thus a greater risk for cardiovascular disease and mortality. Non-invasive transcutaneous spinal cord stimulation (TSCS) has been shown to modulate cardiovascular responses at rest in individuals with SCI, yet its effectiveness to enhance exercise performance acutely, or promote superior physiological adaptations to exercise following an intervention, in an adequately powered cohort is unknown.

Effectiveness of a physiotherapist-led triage and treatment service on WAITing time for adults with musculoskeletal pain referred to Australian public hospital physiotherapy clinics: a protocol for the WAIT-less trial.

Introduction: Musculoskeletal pain is the second leading cause of disease burden in Australia, and there is a need to investigate new models of care to cope with the increasing demand for health services. This paper describes the protocol for a randomised controlled trial investigating whether a physiotherapist-led triage and treatment service is non-inferior for improving function at 6 months and superior for reducing treatment waiting times, compared with usual care for patients with musculoskeletal pain referred to public hospital outpatient physiotherapy clinics.

Methods And Analysis: A total of 368 participants (184 per arm) will be recruited from six public hospitals located in metropolitan Sydney, Australia.

Impact of mindfulness-based tri-modal prehabilitation on functional recovery and selected surgical outcomes of patients with colorectal cancer admitted to surgical hospital wards: the first international randomised control trial for mindfulness-based tri-modal prehabilitation.

Introduction: Colorectal cancer (CRC) is the third most common and second most deadly cancer worldwide, with significant morbidity and mortality risks. Despite advancements in surgical care, postoperative complications and recovery challenges persist. The severity of these issues is linked to preoperative functional capacity and emotional distress.

Multicentre study conducted across centres in the USA, Europe and Australia to assess the safety and effectiveness of a bilateral hypoglossal nerve stimulation system for the treatment of obstructive sleep apnoea in adults: a protocol for a pivotal, multicentre, open-label, single-arm study.

Introduction: Obstructive sleep apnoea (OSA) is characterised by blood oxygen desaturations and sleep disruptions manifesting undesirable consequences. Existing treatments including oral appliances, positive airway pressure (PAP) therapy and surgically altering the anatomy of the pharynx have drawbacks including poor long-term adherence or often involving irreversible, invasive procedures. Bilateral hypoglossal nerve stimulation (HNS) is a new treatment for managing OSA, and this study is intended to determine whether an HNS system is a safe and effective treatment option for adults with OSA.

DIAMACC: protocol of a prospective diagnostic accuracy study of the maximal systolic acceleration to detect peripheral arterial disease in patients with diabetes-related foot ulceration in the Netherlands.

Introduction: Foot ulcers are one of the most serious complications of diabetes, leading to significant risks on amputation and mortality. Peripheral arterial disease (PAD) is an important factor for the development and the outcome of diabetic foot ulcers (DFU). Although prompt and accurate detection of PAD is critical to reduce complications, its diagnosis can be challenging with currently used bedside tests (such as ankle-brachial index and toe pressure) due to medial arterial calcification.

Move to improve - Prescribing physical activity and deprescribing paracetamol for low back pain: Protocol for a hybrid type III feasibility study.

Introduction: People experiencing low back pain (LBP) could potentially benefit from multimedia educational resources that integrate self-management strategies and improve awareness of the benefits of staying active and about medications that offer limited benefits, such as paracetamol. Primary care waiting rooms are potential spaces for presenting health promotion resources to improve health literacy through the dissemination of easily accessible health information. This feasibility study aims to explore the feasibility of conducting a large-scale trial to investigate the benefits of multimedia educational resources delivered at outpatient physiotherapy waiting rooms of public hospitals to support patients to participate in physical activity and reduce paracetamol intake for LBP.

Protocol for a mixed-methods randomised controlled trial evaluating the psychosocial effects of an expressive arts-based intervention on adults with age-related macular degeneration.

Introduction: Age-related macular degeneration (AMD) is a prevalent eye disease among middle-aged and older adults. AMD leaves the patient with irreversible deteriorating vision, which profoundly impacts their daily lives and psychosocial well-being. Given the limited studies addressing the psychosocial needs of adults with AMD and, in particular, using an expressive arts-based intervention (EXABI) as an intervention, this study aims to investigate the effectiveness of such an intervention in enhancing the psychosocial well-being of adults with AMD.

Physical activity for children and adolescents with attention deficit hyperactivity disorder: a protocol of a systematic review and meta-analysis.

Introduction: Attention deficit hyperactivity disorder (ADHD) is a common neurodevelopmental disorder among children and adolescents. The disorder negatively influences their academic performance and social relations, and their quality of life (QoL) is lower than that of peers without ADHD. The majority of children and adolescents with ADHD are treated with medication that potentially has an insufficient effect or frequently occurring adverse events.

Protocol for the development of a global core outcome set for the surgical treatment of differentiated thyroid cancer: a literature review and international Delphi survey.

Introduction: There is a lack of consensus on the optimal surgical strategy for differentiated thyroid cancer (DTC), partly due to inconsistent reporting of outcomes. This limits the ability to compare study results, hindering the ability to draw conclusions regarding novel treatment strategies. The development of a core outcome set (COS) reduces heterogeneity in the selection and reporting of clinical trial outcomes.

Neoadjuvant adebrelimab combined with chemotherapy (cisplatin/carboplatin and etoposide) for limited-stage small-cell lung cancer: a study protocol of phase 2 trial (NIUS).

Introduction: Small-cell lung cancer (SCLC) is a highly malignant neuroendocrine tumour, and concurrent chemoradiotherapy is the current recommended treatment for limited-stage SCLC. However, the overall survival (OS) of patients with SCLC remains poor. Therefore, improving the survival of patients with SCLC and benefitting more patients are urgent clinical requirements.