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.

Effects of a combined exercise and dietary intervention on clinical outcomes in patients with ovarian cancer: the Physical Activity and Dietary intervention in OVArian cancer (PADOVA) randomized controlled trial.

Objective: Chemotherapy treatment modifications can impact survival in patients with ovarian cancer, particularly when the relative dose intensity falls below 85%. Exercise and dietary interventions may benefit treatment tolerability. This study aimed to explore the effects of a combined exercise and dietary intervention on secondary outcomes of the Physical Activity and Dietary intervention in OVArian cancer (PADOVA) trial, specifically relative dose intensity and progression-free survival.

The multiple mediating effects of vision-specific factors and depression on the association between visual impairment severity and fatigue: a path analysis study.

Background: Severe fatigue is a common symptom for people with visual impairment, with a detrimental effect on emotional functioning, cognition, work capacity and activities of daily living. A previous study found that depression was one of the most important determinants of fatigue, but less is known about disease-specific factors in this patient population. This study aimed to explore the association between visual impairment severity and fatigue in adults with low vision, both directly and indirectly, with vision-specific factors and depression as potential mediators.

Rationale and design for the randomized placebo-controlled double-blind trial studying the effect of single antiplatelet therapy (clopidogrel) versus dual antiplatelet therapy (clopidogrel/acetylsalicylic acid) on the occurrence of atherothrombotic events following lower extremity peripheral transluminal angioplasty (CLEAR-PATH).

Rationale: Antiplatelet therapy (APT) is the standard of care after endovascular revascularization (EVR) in patients with peripheral artery disease (PAD). APT aims to prevent both major adverse cardiovascular events (MACE) and major adverse limb events (MALE). Nonetheless, the rates of MACE and MALE after EVR remain high.

Corrigendum to "Effectiveness of L-serine supplementation in children with a GRIN2B loss-of-function mutation: Rationale and protocol for single patient (n-of-1) multiple cross-over trials" [Contemp. Clin. Trials Commun. 36 (2023)/ DOI: 10.1016/j.conctc.2023.101233].

[This corrects the article DOI: 10.1016/j.conctc.

Hyperbaric Oxygen Therapy and Late Local Toxic Effects in Patients With Irradiated Breast Cancer: A Randomized Clinical Trial.

Importance: Hyperbaric oxygen therapy (HBOT) is proposed as treatment for late local toxic effects after breast irradiation. Strong evidence of effectiveness is lacking.

Objective: To assess effectiveness of HBOT for late local toxic effects in women who received adjuvant radiotherapy for breast cancer.

Daily intranasal palivizumab to prevent respiratory syncytial virus infection in healthy preterm infants: a phase 1/2b randomized placebo-controlled trial.

Background: Mucosal administration of monoclonal antibodies (mAbs) against respiratory pathogens is a promising alternative for systemic administration because lower doses are required for protection. Clinical development of mucosal mAbs is a highly active field yet clinical proof-of-concept is lacking.

Methods: In this investigator-initiated, double-blind, randomized placebo-controlled trial, we evaluated intranasal palivizumab for the prevention of RSV infection in preterm infants (Dutch Trial Register NTR7378 and NTR7403).

Effectiveness of L-serine supplementation in children with a loss-of-function mutation: Rationale and protocol for single patient (n-of-1) multiple cross-over trials.

Rationale: Loss-of-function (LoF) mutations in result in neurologic abnormalities due to -methyl-D-aspartate receptor (NMDAR) dysfunction. Affected persons present with various symptoms, including intellectual developmental disability (IDD), hypotonia, communication deficits, motor impairment, complex behavior, seizures, sleep disorders and gastrointestinal disturbance. Recently, experiments showed that D-serine mitigates function to GluN2B (mutation)-containing NMDARs.

The association between delinquent peer affiliation and disruptive behavior interacts with functional brain correlates of reward sensitivity: a biosocial interaction study in adolescent delinquents.

Background: Affiliating with delinquent peers may stimulate the development of antisocial behavior, especially for adolescents who are sensitive to social rewards. The current study examines whether the association between delinquent peer affiliation (DPA) and disruptive behavior interacts with functional brain correlates of reward sensitivity in early onset male adolescents delinquents.

Methods: Childhood arrestees ( = 126, mean age = 17.

Safety of Switching From a Vitamin K Antagonist to a Non-Vitamin K Antagonist Oral Anticoagulant in Frail Older Patients With Atrial Fibrillation: Results of the FRAIL-AF Randomized Controlled Trial.

Background: There is ambiguity whether frail patients with atrial fibrillation managed with vitamin K antagonists (VKAs) should be switched to a non-vitamin K oral anticoagulant (NOAC).

Methods: We conducted a pragmatic, multicenter, open-label, randomized controlled superiority trial. Older patients with atrial fibrillation living with frailty (≥75 years of age plus a Groningen Frailty Indicator score ≥3) were randomly assigned to switch from international normalized ratio-guided VKA treatment to an NOAC or to continued VKA treatment.

Personalised electronic health programme for recovery after major abdominal surgery: a multicentre, single-blind, randomised, placebo-controlled trial.

Background: Despite the adoption of minimally invasive techniques, recovery after abdominal surgery takes a long time. Electronic health (eHealth) modalities can provide guidance to patients, facilitating early return to normal activities. We aimed to assess the impact of a personalised eHealth programme on patients' return to normal activities after major abdominal surgery.

Septal Midwall Late Gadolinium Enhancement in Ischemic Cardiomyopathy and Nonischemic Dilated Cardiomyopathy-Characteristics and Prognosis.

Septal midwall late gadolinium enhancement (LGE) is a characteristic finding on cardiac magnetic resonance imaging (CMR) in nonischemic dilated cardiomyopathy (DCM) and is associated with adverse events. Its significance in ischemic cardiomyopathy (ICM) is unknown. With this multicenter observational study, we aimed to study the characteristics of septal midwall LGE and evaluate its prognostic value in ICM.

A Bayesian-adaptive decision-theoretic approach can reduce the sample sizes for multiarm exercise oncology trials.

Objectives: Adaptive designs may reduce trial sample sizes and costs. This study illustrates a Bayesian-adaptive decision-theoretic design applied to a multiarm exercise oncology trial.

Study Design And Setting: In the Physical exercise during Adjuvant Chemotherapy Effectiveness Study (PACES) trial, 230 breast cancer patients receiving chemotherapy were randomized to supervised resistance and aerobic exercise (OnTrack), home-based physical activity (OncoMove) or usual care (UC).

The Relation between Patient-Centered Care and Quality of Life in Women with Endometriosis.

Objective: The objective of this study was to examine the hypothesis that experiences with patient-centered endometriosis care are related to the endometriosis-specific quality of life dimensions "emotional well-being" and "social support."

Design: A secondary regression analysis of two cross-sectional studies was conducted. Participants/Materials: In total, data from 300 women were eligible for analysis.

Development and External Validation of a Novel Nomogram to Predict the Probability of Pelvic Lymph-node Metastases in Prostate Cancer Patients Using Magnetic Resonance Imaging and Molecular Imaging with Prostate-specific Membrane Antigen Positron Emission Tomography.

Background: Preoperative assessment of the probability of pelvic lymph-node metastatic disease (pN1) is required to identify patients with prostate cancer (PCa) who are candidates for extended pelvic lymph-node dissection (ePLND).

Objective: To develop a novel intuitive prognostic nomogram for predicting pathological lymph-node (pN) status in contemporary patients with primary diagnosed localized PCa, using preoperative clinical and histopathological parameters, magnetic resonance imaging (MRI), and prostate-specific membrane antigen (PSMA) positron emission tomography (PET).

Design, Setting, And Participants: In total, 700 eligible patients who underwent robot-assisted radical prostatectomy and ePLND were included in the model-building cohort.

Association between objective neurocognitive functioning and neurocognitive complaints in recurrent high-grade glioma: Longitudinal evidence of cognitive awareness from EORTC brain tumour trials.

Background: Patients' reduced awareness of neurocognitive functioning (NCF) may negatively affect the reliability of patient-reported outcomes (PROs) and clinical decision-making. This study evaluated cognitive awareness, defined as the association between NCF and neurocognitive complaints, over the disease course of patients with recurrent high-grade glioma (HGG).

Methods: We assessed NCF using the EORTC core clinical trial battery and neurocognitive complaints using the Medical Outcome Study questionnaire.

Nosocomial RSV-related In-hospital Mortality in Children <5 Years: A Global Case Series.

Background: According to the World Health Organization, the global burden of nosocomial infections is poorly characterized as surveillance systems are lacking. Nosocomial infections occur at higher rates in low- and lower-middle-income countries (LMICs) than in high-income countries (HICs). Current global RSV burden estimates are largely based on community-acquired infection.

Alternative Randomized Trial Designs in Surgery: A Systematic Review.

Introduction: Randomized controlled trials (RCTs) yield the highest level of evidence but are notoriously difficult to perform in surgery. Surgical RCTs may be hampered by slow accrual, the surgical learning curve, and lack of financial support. Alternative RCT designs such as stepped-wedge randomized controlled trials (SW-RCTs), registry-based randomized controlled trials (RB-RCTs), and trials-within-cohorts (TwiCs) may overcome several of these difficulties.

Cannabinoids to Improve Health-Related Quality of Life in Patients with Neurological or Oncological Disease: A Meta-Analysis.

Cannabinoids have been suggested to alleviate frequently experienced symptoms of reduced mental well-being such as anxiety and depression. Mental well-being is an important subdomain of health-related quality of life (HRQoL). Reducing symptoms and maintaining HRQoL are particularly important in malignant primary brain tumor patients, as treatment options are often noncurative and prognosis remains poor.

Reducing severe fatigue in patients with diffuse glioma: a study protocol for an RCT on the effect of blended cognitive behavioural therapy.

Background: Fatigue is the most frequent and burdensome symptom of patients with diffuse glioma. It is closely linked to decreased health-related quality of life and symptoms such as depression and sleep disturbances. Currently, there is no evidence-based treatment that targets severe fatigue in patients with brain tumours.

Evaluation of an implementation strategy for Individual Placement and Support in the Netherlands: a 30-month observational study.

Background: Individual Placement and Support (IPS) is an evidence-based, effective approach to help people with severe mental illness (SMI) obtain and maintain competitive employment. The aim of the present study was to examine employment outcomes and associations with an organizational and a financial factor in people with SMI who participated in Individual Placement and Support using a multifaceted implementation strategy (IPS + MIS). The goal of this strategy was to improve IPS implementation by enhancing collaboration among mental health care and vocational rehabilitation stakeholders, and realizing secured IPS funding.

International changes in respiratory syncytial virus (RSV) epidemiology during the COVID-19 pandemic: Association with school closures.

Background: Little RSV activity was observed during the first expected RSV season since the COVID-19 pandemic. Multiple countries later experienced out-of-season RSV resurgences, yet their association with non-pharmaceutical interventions (NPIs) is unclear. This study aimed to describe the changes in RSV epidemiology during the COVID-19 pandemic and to estimate the association between individual NPIs and the RSV resurgences.

Functional stress imaging to predict abnormal coronary fractional flow reserve: the PACIFIC 2 study.

Aims: The diagnostic performance of non-invasive imaging in patients with prior coronary artery disease (CAD) has not been tested in prospective head-to-head comparative studies. The aim of this study was to compare the diagnostic performance of qualitative single-photon emission computed tomography (SPECT), quantitative positron emission tomography (PET), and qualitative magnetic resonance imaging (MRI) in patients with a prior myocardial infarction (MI) or percutaneous coronary intervention (PCI).

Methods And Results: In this prospective clinical study, all patients with prior MI and/or PCI and new symptoms of ischaemic CAD underwent 99mTc-tetrofosmin SPECT, [15O]H2O PET, and MRI, followed by invasive coronary angiography with fractional flow reserve (FFR) in all coronary arteries.