369 results match your criteria: "National Health and Medical Research Council Clinical Trials Centre[Affiliation]"

The psychometric properties of the Nepean Belief Scale as a tool for assessing delusions in schizophrenia and related psychotic disorders.

Compr Psychiatry

August 2022

Blacktown Mental Health Service, Western Sydney Local Health District, Australia; University of Sydney, Faculty of Medicine and Health, Sydney Medical School, Nepean Clinical School, Discipline of Psychiatry, Australia; School of Medicine and Translational Health Research Institute, Western Sydney University, Australia. Electronic address:

Objectives: To examine the psychometric characteristics of the Nepean Belief Scale (NBS) in psychiatric inpatients with delusions. The NBS is a five-item, clinician-administered scale that assesses the characteristics of beliefs, i.e.

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Objective: This review aimed to examine the validity of self-report screening questionnaires for identifying eating disorder (ED) risk in adults and adolescents with overweight/obesity.

Method: Five databases were searched from inception to September 2020 for studies assessing validation of self-report ED screening questionnaires against diagnostic interviews in adolescents and adults with overweight/obesity. The review was registered with PROSPERO (https://www.

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Background The plasma concentration of B-type natriuretic peptide (BNP) is a strong predictor of adverse cardiovascular events. The aim of this study was to determine whether the association between plasma BNP concentration and cardiovascular mortality is sustained or diminishes with increasing time after BNP is measured. Methods and Results Six thousand seven hundred forty patients with a history of myocardial infarction or unstable angina who participated in the LIPID (Long-Term Intervention with Pravastatin in Ischemic Disease) trial had plasma BNP concentration measured at baseline and after 1 year.

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Background: Individuals with chronic kidney disease (CKD) are at a very high risk for atherosclerotic cardiovascular disease (ASCVD). New lipid-lowering agents offer hope of improved outcomes where traditional agents have been less efficacious, yet the cost of these agents needs consideration in this population before their widespread application.

Objective: We sought to evaluate the cost-effectiveness of novel lipid-lowering therapies for a CKD population.

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Adverse events in the placebo arm of maintenance therapy trials in advanced ovarian cancer: A systematic review and meta-analysis.

Eur J Cancer

July 2022

Department of Medical Oncology, St George Hospital, Gray St, Kogarah, Sydney, NSW, 2217, Australia; National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Locked Bag 77, Camperdown, NSW, 1450, Australia.

Background: Maintenance treatment is standard of care for front-line (FL) and platinum-sensitive recurrent ovarian cancer (PSROC) following response to chemotherapy. Adverse events (AEs) on maintenance therapies are common and usually attributable to investigational treatments but could also be unrelated. Randomised controlled trial (RCT) with blinded placebo design is the gold standard for determining the relative differences in efficacy and AEs between treatment arms.

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Objectives: Frequent presenters (FPs) to the ED are common and contribute to ED overcrowding. Our aim was to identify the proportion of FPs over a 12-month period and to investigate the sociodemographic, clinical and attendance characteristics of FPs.

Methods: A retrospective cohort study of adult patients (≥18 years) presenting to Auburn Hospital ED between 1 January 2018 to 31 December 2018.

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Article Synopsis
  • The study investigates how various clinicopathologic characteristics affect survival outcomes in patients with head and neck cutaneous squamous cell carcinoma (HNcSCC) that has spread regionally.
  • It focuses on factors such as the number and size of metastatic deposits, presence of extranodal extension (ENE), and immunosuppression using data from 366 patients treated with curative intent.
  • Findings reveal that the number of metastatic deposits significantly impacts overall survival and disease-specific survival, suggesting these insights could improve patient risk stratification and future staging for HNcSCC.
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Peer review aims to select articles for publication and to improve articles before publication. We believe that this process can be infused by kindness without losing rigor. In 2014, the founding editorial team of the (CJKHD) made an explicit commitment to treat authors as we would wish to be treated ourselves.

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Immune checkpoint inhibitors have been incorporated into the treatment of various malignancies. An increasing body of literature is reporting rare but potentially fatal adverse events associated with these agents. In this case series, the authors report the clinical features and outcomes of seven patients who received immune checkpoint inhibitors for different solid organ malignancies and developed a tetrad of immune-related myocarditis, myositis, myasthenia gravis and transaminitis.

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The impact of olaparib dose reduction and treatment interruption on treatment outcome in the SOLO2/ENGOT-ov21 platinum-sensitive recurrent ovarian cancer.

Ann Oncol

June 2022

National Health and Medical Research Council Clinical Trials Centre, The University of Sydney, Sydney, Australia; Department of Medical Oncology, St George Hospital, Kogarah, Australia.

Background: Maintenance treatment with poly (ADP-ribose) polymerase (PARP) inhibitor is now the standard of care in patients with BRCA-mutated platinum-sensitive recurrent ovarian cancer following response to chemotherapy. In the SOLO2 trial, adverse event (AE)-associated olaparib interruption, dose reduction, and discontinuation occurred in 50%, 28%, and 17% of patients, respectively. We used data from the SOLO2 trial to evaluate the impact of dose alterations on survival outcomes and identified baseline characteristics associated with dose alteration.

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Effect of Evolocumab in Patients With Prior Percutaneous Coronary Intervention.

Circ Cardiovasc Interv

March 2022

Thrombolysis in Myocardial Infarction (TIMI) Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (R.H.M.F., A.A.F., K.O., T.A.Z., M.T., J.F.K., S.AM., R.P.G., M.S.S., B.A.B.).

Background: Patients with prior percutaneous coronary intervention (PCI) are at high residual risk for multiple types of coronary events within and beyond the stented lesion. This risk might be mitigated by more intensive LDL-C (low-density lipoprotein cholesterol)-lowering beyond just with statin therapy.

Methods: FOURIER (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk) randomized 27 564 patients with stable atherosclerotic disease on statin to the PCSK9 (proprotein convertase subtilisin-kexin type 9) inhibitor evolocumab or placebo with a median follow-up of 2.

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Childhood obesity remains a major public health issue and priority area for action. Promisingly, obesity prevention interventions in the first 2000 days of life have shown modest effectiveness in improving health behaviours and healthy weight status in children. Yet, researchers in this field face several challenges.

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Chemotherapy in resectable or potentially resectable colon cancer with liver metastases.

Expert Opin Pharmacother

April 2022

Cancer Research Program, School of Public Health and Preventive Medicine, Faculty of Medicine, Monash University, Melbourne, Australia.

Introduction: The treatment of colorectal cancer liver metastases has seen significant improvement in recent years and, for certain patients, the long-term survival and even cure are possible. Despite this improvement, many more questions are yet to be answered: the optimal combination, duration, sequence of therapies, role of biologics and the timing of surgical resection are debated in the literature, with conflicting trial results.

Areas Covered: In this review, the authors highlight the current trial evidence for systemic chemotherapy and biologic therapy for colorectal cancer liver metastases in both the pre and post-resection setting.

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Background: The survival outcomes of patients with advanced non-small cell lung cancer (NSCLC) treated with immune checkpoint inhibitors (ICIs) are variable. This study investigated whether pre- and on-treatment lactate dehydrogenase (LDH) could better prognosticate and select patients for ICI therapy.

Methods: Using data from the POPLAR and OAK trials of atezolizumab versus docetaxel in previously treated advanced NSCLC, the authors assessed the prognostic and predictive value of pretreatment LDH (less than or equal to vs greater than the upper limit of normal).

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Introduction: Little is known about how early (eg, commencing antenatally or in the first 12 months after birth) obesity prevention interventions seek to change behaviour and which components are or are not effective. This study aims to (1) characterise early obesity prevention interventions in terms of target behaviours, delivery features and behaviour change techniques (BCTs), (2) explore similarities and differences in BCTs used to target behaviours and (3) explore effectiveness of intervention components in preventing childhood obesity.

Methods And Analysis: Annual comprehensive systematic searches will be performed in Epub Ahead of Print/MEDLINE, Embase, Cochrane (CENTRAL), CINAHL, PsycINFO, as well as clinical trial registries.

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Perceived Versus Verified Cancer History and Missed Opportunities for Donation in an Australian Cohort of Potential Deceased Solid Organ Donors.

Transplant Direct

February 2022

Collaborative Centre for Organ Donation Evidence, Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.

Background: There is an imperative to maximize donation opportunities given ongoing organ shortages, but donor suitability assessments can be challenging.

Methods: We analyzed an Australian cohort of potential deceased donors 2010 to 2013 to explore misclassification of cancer risk and potential strategies for improvement (decision support, real-time data linkage to existing data sets, and increasing risk tolerance). Cancer history perceived at referral was compared with verified cancer history in linked health records.

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The validity of progression-free survival 2 as a surrogate trial end point for overall survival.

Cancer

April 2022

National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.

Background: Overall survival (OS) is the gold-standard end point for oncology trials. However, the availability of multiple therapeutic options after progression and crossover to receive investigational agents confound and delay OS data maturation. Progression-free survival 2 (PFS-2), defined as the time from randomization to progression on first subsequent therapy, has been proposed as a surrogate for OS.

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Background: In response to the COVID-19 pandemic, 6,287 Australian health care workers (HCWs) were fit tested to N95 filtering facepiece respirators (FFRs). This study determined how readily HCWs were fitted to 8 FFRs and how age and sex influenced testing.

Methods: HCWs were fit tested following the quantitative OSHA protocol.

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Background: Pancreatic ductal adenocarcinoma (PDAC) is a leading cause of cancer death and lacks effective treatment options. Diagnostic endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) biopsies represent an appealing source of material for molecular analysis to inform targeted therapy, as they are often the only available tissue for patients presenting with PDAC irrespective of disease stage. However, EUS-FNA biopsies are typically not used to screen for precision medicine studies due to concerns about low tissue yield and quality.

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Incorporating circulating tumor DNA detection to radiographic assessment for treatment response in advanced EGFR-mutant lung cancer.

Lung Cancer

January 2022

National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, Australia; Cancer Care Centre, St George Hospital, Sydney, Australia. Electronic address:

Purpose: Response Evaluation Criteria in Solid Tumors (RECIST) has limitations but remains the conventional approach for tumor assessments. We explored whether circulating tumor DNA (ctDNA) can be incorporated into RECIST to provide a more robust measure of tumor response in advanced EGFR-mutant NSCLC.

Patients And Methods: In FASTACT-2, patients with advanced NSCLC received platinum/gemcitabine intercalated with erlotinib or placebo.

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Outcomes from the use of computerized neurocognitive testing in a recurrent glioblastoma clinical trial.

J Clin Neurosci

December 2021

Department of Neurology, Austin Health, 145 Studley Road, Heidelberg, Vic 3084, Australia.

Assessment of neurocognitive function (NCF) is important in brain tumor clinical trials, however there are varying methodologies available. We used the Cogstate computerized NCF testing battery and the mini-mental state examination (MMSE) to prospectively assess cognition in adult patients with recurrent glioblastoma (GBM) enrolled in the CABARET randomized phase II clinical trial of bevacizumab versus bevacizumab plus carboplatin chemotherapy. We determined completion rates; compared NCF results between trial arms; and assessed baseline NCF as a predictor of survival outcome.

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Aim: The American Joint Committee on Cancer (AJCC) melanoma staging system eighth edition (AJCC-8) was recently released to provide accurate staging reflecting advances in the treatment of melanoma. Using population registry data, this study independently validates and compares the prognostic performance of AJCC-8 to the seventh edition (AJCC-7).

Methods: We extracted patient-, tumor-related, and survival data from the SEER-18 registry between 2010 and 2015.

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Aim: To assess the cost-effectiveness of professional-mode flash glucose monitoring in adults with type 2 diabetes in general practice compared with usual clinical care.

Methods: An economic evaluation was conducted as a component of the GP-OSMOTIC trial, a pragmatic multicentre 12-month randomised controlled trial enrolling 299 adults with type 2 diabetes in Victoria, Australia. The economic evaluation was conducted from an Australian healthcare sector perspective with a lifetime horizon.

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