Does primary posterior tracheopexy prevent collapse of the trachea in newborns with oesophageal atresia and tracheomalacia? A study protocol for an international, multicentre randomised controlled trial (PORTRAIT trial).

Introduction: Tracheomalacia (TM) often occurs in children with oesophageal atresia (OA), leading to recurrent respiratory symptoms and in severe cases to blue spells or ultimately respiratory arrest. In some patients, a secondary posterior tracheopexy may then be indicated. This secondary surgery, as well as respiratory morbidity, may be prevented by performing a primary posterior tracheopexy (PPT) concurrent with primary OA correction.

Methodological review to develop a list of bias items for adaptive clinical trials: Protocol and rationale.

Background: Randomized-clinical trials (RCTs) are the gold-standard for comparing health care interventions, but can be limited by early termination, feasibility issues, and prolonged time to trial reporting. Adaptive clinical trials (ACTs), which are defined by pre-planned modifications and analyses that occur after starting patient recruitment, are gaining popularity as they can streamline trial design and time to reporting. As adaptive methodologies continue to be adopted by researchers, it will be critical to develop a risk of bias tool that evaluates the unique methodological features of ACTs so that their quality can be improved and standardized for the future.

Effectiveness and cost-effectiveness of a structured integrated post-pulmonary embolism follow-up care model (Attend-PE): a rationale and protocol for a multicentre clinical pre-post study.

Introduction: Patients with pulmonary embolism (PE) experience impaired functional ability and reduced quality of life long after discharge from the hospital. However, there are no structured follow-up programmes in Denmark for these patients, and there is considerable variation in practice patterns of post-PE management. No studies have investigated the effectiveness of structured follow-up care models in patients with PE.

Unlocking the transformative potential of data science in improving maternal, newborn and child health in Africa: a scoping review protocol.

Introduction: Application of data science in maternal, newborn, and child health (MNCH) across Africa is variable with limited documentation. Despite efforts to reduce preventable MNCH morbidity and mortality, progress remains slow. Accurate data are crucial for holding countries accountable for tracking progress towards achieving the Sustainable Development Goal 3 targets on MNCH.

Discontinuation of β-blocker therapy in stabilised patients after acute myocardial infarction (SMART-DECISION): rationale and design of the randomised controlled trial.

Introduction: There is a lack of evidence to support the effectiveness of prolonged β-blocker therapy after stabilisation of patients with acute myocardial infarction (AMI) without heart failure (HF) or left ventricular systolic dysfunction.

Methods And Analysis: The SMart Angioplasty Research Team: DEcision on Medical Therapy in Patients with Coronary Artery DIsease or Structural Heart Disease Undergoing InterventiON (SMART-DECISION) trial is a multicentre, prospective, open-label, randomised, non-inferiority trial designed to determine whether discontinuing β-blocker therapy after ≥1 year of maintenance in stabilised patients after AMI is non-inferior to continuing it. Patients eligible for participation are those without HF or left ventricular systolic dysfunction (ejection fraction >40%) who have been continuing β-blocker therapy for ≥1 year after AMI.

Interventions to improve patient health education competence among nursing personnel: a scoping review protocol.

Introduction: Patient health education has gradually become an indispensable and important part of nursing work. However, nursing personnel's performance in this domain remains below satisfactory levels. The absence of patient health education competence (PHEC) constitutes a significant impediment to the effective implementation of such education by nursing personnel.

Effect of communicating genetic risk of type 2 diabetes and wearable technologies on wearable device-measured behavioural outcomes in East Asians: protocol of a randomised controlled trial.

Introduction: The communication of information about the risk of type 2 diabetes (T2D) alone has not been associated with changes in habitual behaviours among individuals of European ancestry. In contrast, the use of wearable devices that monitor physical activity (PA) has been associated with behavioural changes in some studies. It is uncertain whether risk communication might enhance the effects of wearable devices.

Cluster headache and galcanezumab: the first real-world Brazilian study and an expert consensus on its use among other treatments.

Objective: To present the first Brazilian real-world results with galcanezumab and provide a consensus expert opinion on the prophylactic treatment of cluster headache (CH) in Brazil.

Methods: The first part of the study (real-world results) was observational, prospective, uncontrolled, and descriptive. A sample of 44 consecutive patients with episodic or chronic CH were evaluated and treated in a traditional tertiary clinic from March 2020 to June 2024.

Comparative efficacy of non-pharmacological management for chronic prostatitis/chronic pelvic pain syndrome: a systematic review and network meta-analysis protocol.

Background: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) has posed a significant burden on affected individuals and healthcare systems. While pharmacological treatments are commonly used, non-pharmacological management strategies have gained attention for their potential benefits in improving CP/CPPS symptoms. However, the comparative efficacy of these non-pharmacological interventions remains unclear.

Exploring the effects of ime-restricted ating on body weight and associated cardiometabolic outcomes in outh frican women living with HIV (TESSA): protocol for a randomised controlled trial.

Introduction: We codesigned an intervention with a low-resourced community with the aim to investigate the effects of time-restricted eating (TRE) on changes in body weight and associated cardiometabolic outcomes in South African women living with overweight/obesity and HIV who have initiated dolutegravir (DTG)-based antiretroviral therapy (ART).

Methods And Analysis: Women with overweight or obesity (body mass index ≥25 kg/m², no upper limit), aged 20-45 years, living with HIV and in a low-resourced community, and receiving DTG-based ART for less than 2 years will be recruited from a community healthcare centre in Khayelitsha, Cape Town (n=152). Participants will be randomised 1:1 to the TRE group (n=76) or standard of care control group (n=76) for 12 months.

Supporting resident-centred decision-making about transitions from long-term care homes to hospital: a qualitative study protocol.

Introduction: Burdensome care transitions may occur despite clinicians' engagement in care planning discussions with residents and their family/friend care partners. Conversations about potential hospital transfers can better prepare long-term care (LTC) residents, their families and care providers for future decision-making. Lack of such discussions increases the likelihood of transitions that do not align with residents' values.

Vertebroplasty for painful osteoporotic vertebral compression fractures: a protocol for a single-center doubled-blind randomized sham-controlled clinical trial. VOPE2.

Background: One in three women and one in five men over the age of 50 will experience an osteoporotic fracture. Vertebral fractures can be very painful, affect patients' daily function, and in severe cases require hospitalization. Traditionally, fracture pain is treated conservatively with analgesics, and bracing.

Protocol for a multicentric, double-blind, randomised controlled trial of hyperbaric oxygen therapy (HBOT) versus sham for treating vaso-occlusive crisis (VOC) in sickle cell disease (SCD) in patients aged 8 years or older (HBOT-SCD study).

Introduction: Sickle cell disease (SCD) is one of the most common genetic diseases in the world, annually affecting approximately 310 000 births and causing >100 000 deaths. Vaso-occlusive crisis (VOC) is the most frequent complication of SCD, leading to bone pain, thoracic pain (acute chest syndrome) and/or abdominal spasms. It is the main cause of mortality in patients with SCD, reducing life expectancy.

onitoring drug fficacy through ulti-mics esearch initiative in lzheimer's isease (MEMORI-AD): A protocol for a multisite exploratory prospective cohort study on the drug response-related clinical, genetic, microbial and metabolomic signatures in Filipino patients with Alzheimer's disease.

Introduction: Dementia is one of the leading causes of disability among older people aged 60 years and above, with majority eventually being diagnosed with Alzheimer's disease (AD). Pharmacological agents approved for dementia include acetylcholinesterase enzyme (AChE) inhibitors like rivastigmine, donepezil and galantamine and the N-methyl-D-aspartate (NMDA) receptor antagonist memantine, prescribed as monotherapy or in combination with each other, depending on the severity of disease. There is currently no available study demonstrating the clinical response to these drugs for AD in the Filipino population.

Evaluation of safety and efficacy of intracranial self-expanding drug-eluting stents for symptomatic intracranial atherosclerotic stenosis: a prospective, multicentre, randomised controlled, superiority clinical trial protocol.

Background: In-stent restenosis (ISR) is a crucial factor that affects the long-term efficacy of intracranial bare metal stent (BMS) implantation for intracranial atherosclerotic stenosis (ICAS). Patients with intracranial ISR are at a high risk of recurrent ischaemic events. The NOVA intracranial drug-eluting stent (DES) trial demonstrates that a DES can reduce ISR and stroke recurrence after intracranial bare stent implantation.

Pemafibrate for treating MASLD complicated by hypertriglyceridaemia: a multicentre, open-label, randomised controlled trial study protocol.

Introduction: Non-alcoholic fatty liver disease, now known as metabolic dysfunction-associated steatotic liver disease (MASLD), is a phenotype of the metabolic syndrome in the liver and is clearly associated with metabolic abnormalities such as hyperglycaemia and dyslipidaemia. Although the prevalence of MASLD is increasing worldwide, there is currently no consensus on the efficacy and safety of the drugs used to treat MASLD/metabolic dysfunction-associated steatohepatitis (MASH). Pemafibrate, a selective peroxisome proliferator-activated receptor alpha modulator, was designed to have higher peroxisome proliferator-activated receptor alfa (PPARα) agonist activity and selectivity than existing PPARα agonists, and in development trials, without increasing creatinine levels, lipid parameters and alanine aminotransferase (ALT) were significantly improved.

Mediating role of gut microbiota on Baduanjin for cognitive function in community-dwelling older adults with mild cognitive impairment: a study protocol for a cluster randomised controlled trial.

Introduction: The gut microbiome plays an important role in maintaining both cognitive and physical functions in older adults, and gut dysbiosis is an important pathophysiological mechanism of mild cognitive impairment (MCI) in older adults. As a typical traditional Chinese mind-body exercise, regular Baduanjin training has been shown to improve cognitive function and modulate the gut microbiome in community-dwelling older adults. However, the potential role of the gut microbiome in the benefits of Baduanjin on cognitive function remains unclear.

TENDINopathy Severity Assessment-Achilles: a study protocol for cross-cultural adaptation and psychometric properties patient-reported outcome instrument in Persian athletes with Achilles tendinopathy.

Patient-reported outcome measurements (PROMs) are important to evaluate the impact of clinical practice in athletes with Achilles tendinopathy (AT). The TENDINopathy Severity assessment-Achilles (TENDINS-A) is a PROM that measures the pain, symptoms and physical function associated with AT. This study aims to translate, cross-culturally adapt and measure the properties of the Persian language version of the TENDINS-A (Persian-TENDINS-A) in athletes with AT.

Allostatic load modelling, lifestyle and cardiological risk factor: evidence for integrating patient profiling in the optimisation of pharmacological therapies during follow-ups in hospital setting - PLAY-UP cohort study protocol.

Introduction: The allostatic load (AL) is a framework for conceptualising the physiological multisystemic impact of prolonged exposure to stress and its related side effects on mental health.Stress due to AL can influence the development and outcomes of cardiovascular diseases. AL increases the risk of coronary and peripherical artery diseases.