Aortic aneurysm sac filling with AneuFix injectable polymer during endovascular aneurysm repair: feasibility and safety trial study protocol.

Introduction: Type II endoleaks (T2ELs) following endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm (AAA) can lead to aneurysm growth, compromising the stent graft seal and risking rupture. Preventing these endoleaks during EVAR involves filling the AAA sac around the stent graft to exclude the aneurysm and block any arteries causing the endoleak. This study investigates the feasibility and safety of using AneuFix, a biocompatible injectable polymer developed by TripleMed (Geleen, the Netherlands), for aneurysmal sac filling during EVAR in high-risk T2EL patients.

Efficacy and safety of butylphthalide in patients with mild cognitive impairment: a multicentre, randomised, double-blind, placebo-controlled trial (EBMCI study).

Introduction: The efficacy of multitarget neuroprotective drug DL-3-n-butylphthalide (NBP) in improving cognitive function has been confirmed in patients with vascular cognitive impairment without dementia. However, its efficacy in patients with symptomatic predementia phase of Alzheimer's disease remains uncertain. This study aims to evaluate the efficacy and safety of NBP in improving cognitive function in patients with mild cognitive impairment (MCI) through a clinical randomised controlled trail.

Geographical targeting of active case finding for tuberculosis in Pakistan using hotspots identified by artificial intelligence software (SPOT-TB): study protocol for a pragmatic stepped wedge cluster randomised control trial.

Introduction: Pakistan has significantly strengthened its capacity for active case finding (ACF) for tuberculosis (TB) that is being implemented at scale in the country. However, yields of ACF have been lower than expected, raising concerns on its effectiveness in the programmatic setting. Distribution of TB in communities is likely to be spatially heterogeneous and targeting of ACF in areas with higher TB prevalence may help improve yields.

Dual-wavelength dye laser combined with betamethasone injection for treatment of keloids: protocol of a randomised controlled trial.

Introduction: Keloids, benign fibroproliferative tumours characterised by excessive fibroblast proliferation and over-deposition of extracellular matrix, pose a therapeutic challenge with high recurrence rates. Betamethasone (diprospan) injection (BI) is one of the most common non-invasive therapies for keloids. Pulsed dye laser (PDL) has the function of closing microvessels, which may become one of the auxiliary treatment methods of BI and may enhance its curative effect.

Psychosocial outcomes following emergency laparotomy (POLO) study: a study protocol for a multicentre mixed-methods prospective cohort study assessing the psycho-social outcomes following emergency laparotomy in adults.

Introduction: Morbidity from an emergency laparotomy (EmLap) is difficult to define and poorly understood. Morbidity is a holistic concept, reliant upon an interplay of bio-psychosocial outcomes that evolve long after discharge. To date, no previous study has explored the psychosocial outcomes following EmLap as a collective, nor their change over time.

Intervention strategies for management of comorbid depression among individuals with hypertension: a scoping review protocol.

Introduction: Hypertension and depression often coexisted, leading to poor health outcome and significant challenges in healthcare management. Since no guidelines or consensus are available for health professionals to manage this comorbidity, identifying interventions in current literature is crucial for gaining a clear picture of evidence and informing future research directions and clinical practice. This scoping review is designed to address this gap by systematically mapping the range of potential interventions for managing comorbid hypertension and depression.

Evaluating the efficacy of wearable biofeedback on the outcomes of exercise interventions in people with chronic non-specific spinal pain: protocol for a systematic review and meta-analysis.

Introduction: Wearable neuromuscular and biomechanical biofeedback technology has the potential to improve patient outcomes by facilitating exercise interventions. We will conduct a systematic review to examine whether the addition of wearable biofeedback to exercise interventions improves pain, disability and quality of life beyond exercise alone for adults with chronic non-specific spinal pain. Specific effects on clinical, physiological, psychological, exercise adherence and safety outcomes will also be examined.

Mentalisation-based online intervention for psychologically distressed parents: protocol of a non-randomised feasibility trial of the Lighthouse Parenting Programme-Online (LPP-Online).

Introduction: Online-based interventions provide a low-threshold way to reach and support families. The mentalisation-based Lighthouse Parenting Programme is an established intervention aimed at preventing psychopathological development in children. The objective of this study is to examine the feasibility of an online adaptation of the Lighthouse Parenting Programme (LPP-Online), evaluating (a) recruitment capability, compliance, acceptability and satisfaction with the intervention; (b) the psychometric properties of and the acceptability regarding the adjunct psychological evaluation; and (c) the employed materials and resources.

Improving health system responses when patients are harmed: a protocol for a multistage mixed-methods study.

Introduction: At least 10% of hospital admissions in high-income countries, including Australia, are associated with patient safety incidents, which contribute to patient harm ('adverse events'). When a patient is seriously harmed, an investigation or review is undertaken to reduce the risk of further incidents occurring. Despite 20 years of investigations into adverse events in healthcare, few evaluations provide evidence of their quality and effectiveness in reducing preventable harm.

Preoperative electroacupuncture versus sham electroacupuncture for the treatment of postoperative ileus after laparoscopic surgery for colorectal cancer in China: a study protocol for a multicentre, randomised, sham-controlled trial.

Introduction: Postoperative ileus (POI) is a postoperative complication that can cause lingering recovery after colorectal resection and a heavy healthcare system burden. Acupuncture aims to prevent postoperative complications, reduce the duration of POI, help recovery and shorten hospital stays. We hypothesise that preoperative electroacupuncture (EA) can promote POI recovery under the enhanced recovery after surgery protocol after laparoscopic surgery in patients with POI.

Development of the DONOR prediction model on the risk of hypertensive complications in oocyte donation pregnancy: study protocol for a multicentre cohort study in the Netherlands.

Introduction: Oocyte donation (OD) pregnancy is accompanied by a high incidence of hypertensive complications, with serious consequences for mother and child. Optimal care management, involving early recognition, optimisation of suitable treatment options and possibly eventually also prevention, is in high demand. Prediction of patient-specific risk factors for hypertensive complications in OD can provide the basis for this.

Comprehensive Observational and Longitudinal study on the Outbreak of Stroke-related Spasticity focusing on the Early Onset management with Botulinum NeuroToxin (COLOSSEO-BoNT): protocol for a real-world prospective observational study on upper limb spasticity.

Introduction: Poststroke spasticity (PSS) affects up to 40% of patients who had a stroke. Botulinum neurotoxin type A (BoNT-A) has been shown to improve spasticity, but the optimal timing of its application remains unclear. While several predictors of upper limb PSS are known, their utility in clinical practice in relation to BoNT-A treatment has yet to be fully elucidated.

A speech therapy treatment protocol for exercise induced laryngeal obstruction.

Background: Exercise induced laryngeal obstruction (EILO) is a common cause of exertional breathing problems in young individuals, relevant to 5%-7% of young people. It is caused by paradoxical inspiratory adduction of laryngeal structures and diagnosed by continuous visualization of the larynx during high intensity exercise. Empirical data suggest that EILO consists of different subtypes that require different therapeutic approaches.

Norepinephrine weaning guided by the Hypotension Prediction Index in vasoplegic shock after cardiac surgery: protocol for a single-centre, open-label randomised controlled trial - the NORAHPI study.

Introduction: Norepinephrine (NE) is the first-line recommended vasopressor for restoring mean arterial pressure (MAP) in vasoplegic syndrome (vs) following cardiac surgery with cardiopulmonary bypass. However, solely focusing on target MAP values can lead to acute hypotension episodes during NE weaning. The Hypotension Prediction Index (HPI) is a machine learning algorithm embedded in the Acumen IQ device, capable of detecting hypotensive episodes before their clinical manifestation.

Implementing Dementia Care Management into routine care: protocol for a cohort study in Siegen-Wittgenstein, Germany (RoutineDeCM).

Introduction: Dementia Care Management is an evidence-based model of care. It has proven its efficacy and cost-effectiveness and has been applied to different settings and different target groups. However, it is not available in routine care in Germany.

Prehabilitation in patients with cirrhosis awaiting liver transplantation: protocol of a feasibility study.

Introduction: Patients with cirrhosis awaiting liver transplantation (LT) are often frail, and malnourished. The period of time on the waitlist provides an opportunity to improve their physical fitness. Prehabilitation appears to improve the physical fitness of patients before major surgery.

Clinical effectiveness and cost-effectiveness of Structured Psychological Support for people with probable personality disorder in mental health services in England: study protocol for a randomised controlled trial.

Introduction: Evidence-based psychological treatments for people with personality disorder usually involve attending group-based sessions over many months. Low-intensity psychological interventions of less than 6 months duration have been developed, but their clinical effectiveness and cost-effectiveness are unclear.

Methods And Analysis: This is a multicentre, randomised, parallel-group, researcher-masked, superiority trial.

Assessing biomarkers of remission in female patients with anorexia nervosa (REMANO): a protocol for a prospective cohort study with a nested case-control study using clinical, neurocognitive, biological, genetic, epigenetic and neuroimaging markers in a French specialised inpatient unit.

Background: Anorexia nervosa (AN) is a severe psychiatric disorder associated with frequent relapses and variability in treatment responses. Previous literature suggested that such variability is influenced by premorbid vulnerabilities such as abnormalities of the reward system. Several factors may indicate these vulnerabilities, such as neurocognitive markers (tendency to favour delayed reward, poor cognitive flexibility, abnormal decision process), genetic and epigenetic markers, biological and hormonal markers, and physiological markers.

Scoping review protocol on the perception and attitude of women on methods for collecting cervicovaginal samples for human papillomavirus testing in sub-Saharan Africa.

Introduction: Sub-Saharan Africa (SSA) regions have the highest burden of cervical cancer (CC), accounting for nearly a quarter of global mortality. Many women in SSA are reluctant to access CC screening because they are uncomfortable exposing their private parts to healthcare providers. The perception of women who have experienced self-sampling in SSA is yet to be reviewed.