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

Background: In vitro laboratory and animal studies demonstrate a synergistic role for the combination of vancomycin and antistaphylococcal β-lactams for methicillin-resistant Staphylococcus aureus (MRSA) bacteremia. Prospective clinical data are lacking.

Methods: In this open-label, multicenter, clinical trial, adults with MRSA bacteremia received vancomycin 1.

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Aims: In patients with stable coronary heart disease (CHD), we aimed to assess 1. the prognostic power of biomarkers reflecting haemodynamics, micronecrosis, inflammation, coagulation, lipids, neurohumoral activity, and renal function; 2. whether changes in concentrations of these biomarkers over 12 months affected subsequent CHD risk; and 3.

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Purpose: In brain tumours, brain metastases or advanced cancer; treatment with corticosteroids, side effects can add to symptoms. These are best assessed by patients, complementing clinical assessment. We assessed the feasibility and validity of the Dexamethasone Symptom Questionnaire-Chronic (DSQ-Chronic), patient and caregiver versions.

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Randomized phase 2 study of carboplatin and bevacizumab in recurrent glioblastoma.

Neuro Oncol

November 2015

Royal Melbourne Hospital, Parkville, Australia (K.M.F, P.M.P, M.A.R.), National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, Australia (J.S., C.S.B.B., E.H.B, K.S., A.L.); Sir Charles Gairdner Hospital, Nedlands, Australia (A.K.N); School of Medicine and Pharmacology, University of Western Australia, Crawley, Australia (A.K.N); Austin Health, Heidelberg, Australia (L.C., G.F.); Royal North Shore Hospital, St Leonards, Australia (H.W.); Prince of Wales Hospital, Randwick, Australia (E.J.H); University of New South Wales, Sydney, Australia (E.J.H); Monash Medical Centre, Clayton, Australia (R.F.); Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Parkville, Australia (P.M.P., M.A.R., G.F.).

Background: The optimal use of bevacizumab in recurrent glioblastoma (GBM), including the choice of monotherapy or combination therapy, remains uncertain. The purpose of this study was to compare combination therapy with bevacizumab monotherapy.

Methods: This was a 2-part randomized phase 2 study.

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Purpose: Psychological responses to cancer are widely believed to affect survival. We investigated associations between hope, optimism, anxiety, depression, health utility and survival in patients starting first-line chemotherapy for metastatic colorectal cancer.

Methods: Four hundred twenty-nine subjects with metastatic colorectal cancer in a randomised controlled trial of chemotherapy completed baseline questionnaires assessing the following: hopefulness, optimism, anxiety and depression and health utility.

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Impact of Specific Epidermal Growth Factor Receptor (EGFR) Mutations and Clinical Characteristics on Outcomes After Treatment With EGFR Tyrosine Kinase Inhibitors Versus Chemotherapy in EGFR-Mutant Lung Cancer: A Meta-Analysis.

J Clin Oncol

June 2015

Chee Khoon Lee, Pei Ni Ding, Sarah J. Lord, and Val Gebski, National Health and Medical Research Council Clinical Trials Centre, The University of Sydney; Chee Khoon Lee and Matthew Links, Cancer Care Centre, St George Hospital; Pei Ni Ding, Liverpool Hospital; Sarah J. Lord, School of Medicine, The University of Notre Dame; Nick Pavlakis, Royal North Shore Hospital, Sydney, Australia; Yi-Long Wu, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangdong; Caicun Zhou, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai, China; Akira Inoue, Tohoku University Hospital, Sendai; Tetsuya Mitsudomi, Kinki University School of Medicine, Osaka-Sayama, Japan; Rafael Rosell, Catalan Institute of Oncology, Germans Trias i Pujol Health Sciences Institute and Hospital, Barcelona, Spain; Richard J. Gralla, Albert Einstein College of Medicine, Jacobi Medical Center, Bronx, NY; James Chih-Hsin Yang, Graduate Institute of Oncology, National Taiwan University, and National Taiwan University Hospital, Taipei, Taiwan.

Purpose: We examined the impact of different epidermal growth factor receptor (EGFR) mutations and clinical characteristics on progression-free survival (PFS) in patients with advanced EGFR-mutated non-small-cell lung cancer treated with EGFR tyrosine kinase inhibitors (TKIs) as first-line therapy.

Patients And Methods: This meta-analysis included randomized trials comparing EGFR TKIs with chemotherapy. We calculated hazard ratios (HRs) and 95% CIs for PFS for the trial population and prespecified subgroups and calculated pooled estimates of treatment efficacy using the fixed-effects inverse-variance-weighted method.

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Regional variation in identified cancer care needs of early-career oncologists in China, India, and Pakistan.

Oncologist

May 2015

Duke Cancer Institute, Department of Surgery, Department of Pathology, and Department of Immunology, Duke University Medical Center, Durham, North Carolina, USA; Department of Oncology, Allama Iqbal Medical College, Lahore, Pakistan; Department of Surgical Oncology, Tata Memorial Hospital, Mumbai, India; Clinical Trials Unit, Aga Khan University, Karachi, Pakistan; Capital Medical University Cancer Center, Beijing, People's Republic of China; National Health and Medical Research Council Clinical Trials Centre, Royal Prince Alfred and Concord Hospitals, University of Sydney, Sydney, New South Wales, Australia; Department of Precision Oncology, Asian Institute of Oncology, Sion, Mumbai, India; Duke Global Health Institute, Duke University, Durham, North Carolina, USA; Department of Medical Oncology, Tata Medical Center, Kolkata, India; Research Triangle Institute, Research Triangle Park, North Carolina, USA; Flatiron Health, New York, New York, USA.

Background: Cancer incidence and mortality is increasing in the developing world. Inequities between low-, middle-, and high-income countries affect disease burden and the infrastructure needs in response to cancer. We surveyed early-career oncologists attending workshops in clinical research in three countries with emerging economies about their perception of the evolving cancer burden.

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Elevated Intraocular Pressure in Patients Undergoing Penetrating Keratoplasty and Descemet Stripping Endothelial Keratoplasty.

J Glaucoma

April 2016

Departments of *Sydney Eye Hospital †Save Sight Institute, Discipline of Ophthalmology, Sydney Eye Hospital Campus, The University of Sydney ‡National Health and Medical Research Council Clinical trials Centre, University of Sydney, Sydney, Australia.

Purpose: Our aim was to compare changes in intraocular pressure (IOP) and management of glaucoma in patients undergoing either penetrating keratoplasty (PK) or Descemet stripping endothelial keratoplasty (DSEK).

Method: A retrospective review of all patients who underwent primary corneal transplantation at Sydney Eye Hospital (Sydney, Australia) from January 2008 to December 2010 was performed. Eyes with comparable indications and either primary PK or DSEK with 12 months of follow-up were included.

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Purpose: Metastatic gastrointestinal stromal tumour (GIST) is generally an incurable disease with variable response to imatinib. We aimed to develop prognostic nomograms to predict overall survival (OS) and progression-free survival (PFS) for patients treated with imatinib.

Methods: Nomograms were developed in a training cohort (n=330) of patients treated in a randomised trial (EORTC-ISG-AGITG 62005 phase III study) using Cox regression models, and validated in patients (n=236) treated in routine clinical care from six referral centres.

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Primary congenital glaucoma outcomes: lessons from 23 years of follow-up.

Am J Ophthalmol

April 2015

Discipline of Ophthalmology, University of Sydney, Sydney, NSW, Australia; Eye and Developmental Genetics Research Group, Western Sydney Genetics Program, The Children's Hospital at Westmead, Sydney, NSW, Australia; Department of Ophthalmology, The Children's Hospital at Westmead, Sydney, NSW, Australia.

Purpose: To determine in primary congenital glaucoma whether age of presentation influences surgical success, the degrees of angle surgery needed to achieve glaucoma control, and whether there are critical ages where glaucoma progresses, requiring further surgical management.

Design: Retrospective cohort study.

Methods: The medical records of patients with primary congenital glaucoma over a 23-year period were reviewed: 192 procedures were performed on 117 eyes (70 patients).

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Objective: People with diabetes frequently develop vascular disease. We investigated the relationship between blood 25-hydroxyvitamin D (25OH-D) concentration and vascular disease risk in type 2 diabetes.

Research Design And Methods: The relationships between blood 25OH-D concentration at baseline and the incidence of macrovascular (including myocardial infarction and stroke) and microvascular (retinopathy, nephropathy, neuropathy, and amputation) disease were analyzed with Cox proportional hazards models and logistic regression in an observational study of patients in the 5-year Fenofibrate Intervention and Event Lowering in Diabetes trial.

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Changes in body weight and pulse: outcome events in overweight and obese subjects with cardiovascular disease in the SCOUT trial.

Int J Obes (Lond)

May 2015

The Boden Institute of Obesity, Nutrition Exercise & Eating Disorders, University of Sydney, Sydney, New South Wales, Australia.

Background/objectives: The Sibutramine Cardiovascular OUTcomes (SCOUT) trial showed a significantly increased relative risk of nonfatal cardiovascular events, but not mortality, in overweight and obese subjects receiving long-term sibutramine treatment with diet and exercise. We examined the relationship between early changes (both increases and decreases) in pulse rate, and the impact of these changes on subsequent cardiovascular outcome events in both the placebo and sibutramine groups.

Subjects/methods: 9804 males and females, aged ⩾55 years, with a body mass index of 27-45 kg m(-)(2) were included in this current subanalysis of the SCOUT trial.

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Objective: The role of secondary cytoreductive surgery (SCR) in platinum-sensitive recurrent ovarian cancer (ROC) remains controversial. The overall survival (OS) benefits for surgery reported in observational studies may be due to the selection of patients with better prognosis.

Methods: Using data from the CALYPSO trial, OS of patients who had SCR was compared to those treated with chemotherapy alone.

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Aims: The effects of radiotherapy on health-related quality of life (HRQOL) may influence decisions about adjuvant radiotherapy after breast-conserving surgery. We sought women's ratings of HRQOL during and after radiotherapy.

Materials And Methods: Women completed HRQOL measures before, during and after adjuvant radiotherapy for node-negative, hormone receptor-positive breast cancers that were less than 2 cm in size.

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Background & Aims: Recent observational studies showed that post-operative aspirin use reduces cancer relapse and death in the earliest stages of colorectal cancer. We sought to evaluate the cost-effectiveness of aspirin as an adjuvant therapy in Stage I and II colorectal cancer patients aged 65 years and older.

Methods: Two five-state Markov models were constructed separately for Stage I and II colorectal cancer using TreeAge Pro 2014.

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Aspirin for the prevention of recurrent venous thromboembolism: the INSPIRE collaboration.

Circulation

September 2014

From the National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, Australia (J.S., A.C.K., R.M.); the Division of Internal and Cardiovascular Medicine and Stroke Unit, Department of Internal Medicine, University of Perugia, Perugia, Italy (C.B., G.A.); the Population Health Research Institute, McMaster University, Hamilton, ON, Canada (J.W.E.); the Department of Cardiothoracic and Vascular Sciences, University of Padua, Padua (P.P.); and the Department of Haematology, South Eastern Area Laboratory Services (SEALS), Prince of Wales Hospital, Sydney, Australia (T.A.B.).

Background: In patients with a first unprovoked venous thromboembolism (VTE) the risk of recurrent VTE remains high after anticoagulant treatment is discontinued. The Aspirin for the Prevention of Recurrent Venous Thromboembolism (the Warfarin and Aspirin [WARFASA]) and the Aspirin to Prevent Recurrent Venous Thromboembolism (ASPIRE) trials showed that aspirin reduces this risk, but they were not individually powered to detect treatment effects for particular outcomes or subgroups.

Methods And Results: An individual patient data analysis of these trials was planned, before their results were known, to assess the effect of aspirin versus placebo on recurrent VTE, major vascular events (recurrent VTE, myocardial infarction, stroke, and cardiovascular disease death) and bleeding, overall and within predefined subgroups.

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Pericyte degeneration is an early event in diabetic retinopathy and plays an important role in progression of diabetic retinopathy. Clinical studies have shown that fenofibrate, a peroxisome proliferator-activated receptor α (PPARα) agonist, has robust therapeutic effects on diabetic retinopathy in type 2 diabetic patients. We evaluated the protective effect of PPARα against pericyte loss in diabetic retinopathy.

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Improving treatment for obese women with early stage cancer of the uterus: rationale and design of the levonorgestrel intrauterine device ± metformin ± weight loss in endometrial cancer (feMME) trial.

Contemp Clin Trials

September 2014

School of Public Health and Social Work, Institute for Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Queensland, Australia; Queensland Centre for Gynaecological Cancer, Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia.

Purpose: Endometrial adenocarcinoma (EC) is the most common gynaecologic cancer. Up to 90% of EC patients are obese which poses a health threat to patients post-treatment. Standard treatment for EC includes hysterectomy, although this has significant side effects for obese women at high risk of surgical complications and for women of childbearing age.

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Detection of primary melanoma in individuals at extreme high risk: a prospective 5-year follow-up study.

JAMA Dermatol

August 2014

Discipline of Dermatology, University of Sydney at the Sydney Cancer Centre, Sydney, New South Wales, Australia2Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia3Sydney Melanoma Diagnostic Centre, Sydney Cancer Centre, Sydney, New South.

Importance: The clinical phenotype and certain predisposing genetic mutations that confer increased melanoma risk are established; however, no consensus exists regarding optimal screening for such individuals. Early identification remains the most important intervention in reducing melanoma mortality.

Objective: To evaluate the impact of full-body examinations every 6 months supported by dermoscopy and total-body photography (TBP) on all patients and sequential digital dermoscopy imaging (SDDI), when indicated, on detecting primary melanoma in an extreme-risk population.

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Estimating scenarios for survival time in men starting systemic therapies for castration-resistant prostate cancer: a systematic review of randomised trials.

Eur J Cancer

July 2014

Sydney Medical School, University of Sydney, Edward Ford Building A27, NSW 2006, Australia; National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Locked Bag 77, Camperdown, NSW 1450, Australia; Department of Medical Oncology, Sydney Cancer Centre, RPA and Concord Hospitals, Missenden Road, Camperdown, NSW 2050, Australia. Electronic address:

Background: We sought to estimate worst-case, typical and best-case scenarios for survival in men starting systemic therapies for castration resistant prostate cancer (CRPC).

Methods: We sought randomised phase 3 trials of systemic therapies for CRPC and recorded the following percentiles (represented scenario) from Kaplan-Meier overall survival (OS) curves: 90th (worst-case), 75th (lower-typical), 50th (median), 25th (upper-typical) and 10th (best-case). We determined the accuracy of using simple multiples of the median OS to estimate the other selected percentiles from each curve: 0.

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The relationship between endothelial progenitor cell populations and epicardial and microvascular coronary disease-a cellular, angiographic and physiologic study.

PLoS One

January 2015

Department of Cardiology, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia; The Heart Research Institute, Sydney, New South Wales, Australia; Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.

Article Synopsis
  • Endothelial progenitor cells (EPCs) play a role in protecting against vascular disease, but their relationship with epicardial coronary artery disease (CAD) severity is unclear, leading to this study exploring the connection between different EPC types and coronary health.
  • A study involving 33 patients with isolated left anterior descending artery disease measured coronary health through various physiological tests, isolating early EPCs and late outgrowth endothelial cells (OECs) for further examination.
  • Findings revealed that higher levels of circulating OECs were linked to lower epicardial CAD severity, while early EPCs showed no significant correlation; however, OEC function also impacted coronary flow reserve, indicating differing roles for each EPC population.
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Environmental, personal, and genetic determinants of response to vitamin D supplementation in older adults.

J Clin Endocrinol Metab

July 2014

Population Health Division (M.W., B.T., C.B., C.H., P.M.W., D.C.W., R.E.N.), QIMR Berghofer Medical Research Institute, Brisbane, Queensland 4006, Australia; Centre for Research Excellence in Sun and Health (B.T., P.R.E., M.G.K., D.C.W., R.E.N.), Kelvin Grove, Queensland 4059, Australia; Sydney School of Public Health, The University of Sydney (B.K.A.), Sydney, New South Wales 2006, Australia; NorthWest Academic Centre, The University of Melbourne (P.R.E.), St Albans, Victoria 3021, Australia; Melbourne School of Population and Global Health (D.R.E.), The University of Melbourne, Melbourne, Victoria 3010, Australia; Cancer Epidemiology Centre (D.R.E.), Cancer Council Victoria, Melbourne, Victoria 3004, Australia; National Health and Medical Research Council Clinical Trials Centre (V.G.), Sydney Medical School, The University of Sydney, Sydney, New South Wales 2006, Australia; AusSun Research Laboratory (M.G.K.), Queensland University of Technology, Kelvin Grove, Queensland 4059, Australia; and National Centre for Epidemiology and Population Health (R.M.L.), The Australian National University, Canberra, Australian Capital Territory 0200, Australia; and Menzies Research Institute (A.V.), Hobart, Tasmania 7000, Australia.

Context And Objective: Suboptimal vitamin D status can be corrected by vitamin D supplementation, but individual responses to supplementation vary. We aimed to examine genetic and nongenetic determinants of change in serum 25-hydroxyvitamin D (25(OH)D) after supplementation.

Design And Participants: We used data from a pilot randomized controlled trial in which 644 adults aged 60 to 84 years were randomly assigned to monthly doses of placebo, 30 000 IU, or 60 000 IU vitamin D3 for 12 months.

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Objectives: Leg lymphoedema occurs in up to 60% of women after a complete inguinal-femoral lymphadenectomy for vulvar cancer. To avoid lymphoedema, sentinel lymph node biopsy has become the preferred method of staging. However, false-negative results may influence survival, making the sentinel node procedure unacceptable to many fully informed women.

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Background: The NCIC CTG/AGITG CO.17 trial demonstrated that cetuximab monotherapy improved overall and progression-free survival (OS and PFS) in patients previously treated for advanced colorectal cancer. A strong relationship was observed between benefit from cetuximab and development of rash.

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Neoadjuvant chemotherapy with sequential anthracycline-docetaxel with gemcitabine for large operable or locally advanced breast cancer: ANZ 0502 (NeoGem).

Breast

April 2014

Australia and New Zealand Breast Cancer Trials Group, Newcastle, NSW, Australia; University of Newcastle, Newcastle, NSW, Australia; Department of Surgical Oncology, Calvary Mater Newcastle, Newcastle, NSW, Australia.

Background: Neoadjuvant chemotherapy has a sound rationale for use in women with large operable breast cancer, and achievement of pathological complete response (pCR) is prognostic. Epirubicin and cyclophosphamide followed by docetaxel is a standard chemotherapy regimen for early breast cancer. In metastatic breast cancer the combination of gemcitabine and a taxane has shown promising results.

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