Updated 1-Sep-2014 Adventist HealthCare Limited Human Research Ethics Committee RESEARCH PROJECTS Please note: This document is updated at regular intervals and indicates a projects status at the time the update was issued. If you require confirmation regarding the current status of a project please phone the HREC Executive Officer on (m) 0417 042 300. Project Code 2014-020 Title Researcher Approved Date Status The Vascutek Thoraflex™ Hybrid Post Market Surveillance Professor Tristan Yan Consultant Cardiothoracic Surgeon Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 30-Jul-2014 Approved 2014-019 A Randomized Multicenter Pivotal Study of CDX-011 (CR011-vcMMAE) in Patients with Metastatic, GPNMB Over-Expressing, Triple-Negative Breast Cancer (The "METRIC" Study) Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 23-Jul-2014 Approved 2014-018 ANZUP1304 : A randomised phase 3 trial of enzalutamide in first line androgen deprivation therapy for metastatic prostate cancer (ENZAMET) Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 21-Jul-2014 Approved 2014-017 PUMA-NER-1301: A study of Neratinib plus Capecitabine versus Lapatinib plus Capecitabine in patients with HER2+ Metastatic Breast Cancer who have received two or more prior HER2-directed regimes in the metastatic setting [NALA] ANZUP 1302 : Phase 3 Accelerated BEP Trial: A randomised phase 3 trial of accelerated versus standard BEP chemotherapy for participants with intermediate and poor-risk metastatic germ cell tumours (P3BEP Trial) A multi-centre, single-arm, open-label, post-marketing safety study to evaluate the risk of seizure among subjects with Metastatic CastrationResistant Prostate Cancer (MCRPC) treated with enzalutamide who are at potential increased risk of seizure Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 21-Jul-2014 Approved Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 21-Jul-2014 Approved Associate Professor Henry Woo Australian Clinical Trials Pty Ltd Australian Clinical Trials Suite 406 San Clinic 185 Fox Valley Road Wahroonga NSW 2076 04-Aug-2014 Approved PCI-32765FLR3001: A Randomised, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination with Either Bendamustine and Rituximab (BR) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects with Previously Treated Indolent NonHodgkin Lymphoma (iNHL) Case Study: Ultrasound identification of slipped lap band Dr Jane Freeman San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 30-Jun-2014 Approved Dr Justin Bowra SAH ED 28 Cambridge St Paddington NSW 2021 30-Jun-2014 Approved 2014-016 2014-015 2014-014 2014-013 Updated 1-Sep-2014 2014-012 The MILO Study (MEK Inhibitor in Low-Grade Serous Ovarian Cancer): A Multinational, Randomized, Open-label Phase 3 Study of MEK162 vs. Physician's Choice Chemotherapy in Patients with Recurrent or Persistent Low-grade Serous Carcinomas of the Ovary, Fallopian Tube or Primary Peritoneum Does prior abiraterone or enzalutamide attenuate the effect of subsequent docetaxel chemotherapy in castrate resistant prostate cancer Dr Joseph Rutovitz San Clinical Trials Unit Adventist HealthCare Limited 185 Fox Valley Road Wahroonga NSW 2076 16-Jun-2014 Approved Dr Malinda Itchins Oncology Registrar with Dr Marx 403 San Clinic 185 Fox Valley Road Wahroonga NSW 2076 16-Jun-2014 Approved 2014-010 Testicular Cancer Data Set Specification Pilot Project Associate Professor Henry Woo Australian Clinical Trials Pty Ltd Australian Clinical Trials Suite 406 San Clinic 185 Fox Valley Road Wahroonga NSW 2076 02-Jun-2014 Approved 2014-009 Correlating Ki67 and other prognostic markers with Oncotype DX recurrence score in early breast cancer Monitoring psychiatric side-effects in patients receiving high dose glucocorticoids for medical conditions: A pilot study Dr Kazi Nahar Registrar to Dr Gavin Marx 30-Apr-2014 Approved Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 14-Apr-2014 Approved Amgen Protocol (Denosumab) 20120249: A Randomized, Doubleblind, Multi-centre Phase 2 Trial of Denosumab in Combination with Chemotherapy as First-line Treatment of Metastatic Non-small Cell Lung Cancer PREVAIL: A multinational Phase 3, randomized, double-blind placebocontrolled efficacy and safety study of oral MDV3100 in chemotherapy-naive patients with progressive metastatic prostate cancer who have failed androgen deprivation therapy - Open Label (MDV3100-03) Efficacy and tolerability study of Promega-7 lotion in skin conditioning in aged skin (Macadamia Cream Study) Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 14-Apr-2014 Approved Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 31-Mar-2014 Approved Associate Professor Ross Grant CEO - Australasian Research Institute Chief Scientist Australasian Research Institute 185 Fox Valley Road Wahroonga NSW 2076 26-May-2014 Approved 2014-004 The Influence Of Selected Lifestyle Factors On Maternal And Neonatal Health: In Particular Oxidative And Inflammatory Related Markers Associate Professor Ross Grant CEO - Australasian Research Institute Chief Scientist Australasian Research Institute 185 Fox Valley Road Wahroonga NSW 2076 24-Feb-2014 Approved 2014-003 PROSPER: A Multinational, Phase 3, Randomized, Double Blind, Placebo Controlled, Efficacy and Safety Study of Enzalutamide in Patients with Nonmetastatic Castration Resistant Cancer (MDV3100-14) Hypocalcaemia in patients with metastatic bone disease receiving Denosumab BNITPRV301: A Randomized, Doubleblind, Phase 3 Efficacy Trial of PROSTVACV/F ± GMCSF in Men With Asymptomatic or Minimally Symptomatic Metastatic, Castrate Resistant Prostate Cancer Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 07-Feb-2014 Approved Dr Kazi Nahar Registrar to Dr Gavin Marx 03-Feb-2014 Approved Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 20-Jan-2014 Approved 2014-011 2014-008 2014-007 2014-006 2014-005 2014-002 2014-001 Updated 1-Sep-2014 2013-036 Development of prediction model to identify heart failure patients with high risk of developing hyponatremia during hospitalisation Mr Saepudin Saepudin PhD in School of Biomedical Sciences, Charles Sturt University 4/6 Lampe Avenue Wagga Wagga NSW 2650 2013-035 A Phase 4, Randomized, DoubleBlind, Placebo-Controlled Study of Continued Enzalutamide Treatment Beyond Progression in Patients With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer (MDV3100-10) Prevalence of pre-consultation internet search of specialists who patients have been referred to Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 09-Dec-2013 Approved Associate Professor Henry Woo Australian Clinical Trials Pty Ltd Australian Clinical Trials Suite 406 San Clinic 185 Fox Valley Road Wahroonga NSW 2076 09-Dec-2013 Approved 2013-033 Data collection on pain outcomes of men undergoing a TRUS biopsy Associate Professor Henry Woo Australian Clinical Trials Pty Ltd Australian Clinical Trials Suite 406 San Clinic 185 Fox Valley Road Wahroonga NSW 2076 02-Dec-2013 Approved 2013-032 A diagnostic study to determine the prevalence of EGFR mutations in Asian and Russian patients with advanced NSCLC of Adenocarcinoma and Non-adenocarcinoma histologies: The IGNITE study A Phase 4, Randomized, DoubleBlind, Placebo-Controlled Study of Continued Enzalutamide Treatment Beyond Progression in Patients With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer (MDV3100-10) Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 02-Dec-2013 Approved Associate Professor Henry Woo Australian Clinical Trials Pty Ltd Australian Clinical Trials Suite 406 San Clinic 185 Fox Valley Road Wahroonga NSW 2076 27-Nov-2013 Approved 2013-034 2013-031 2013-030 2013-029 2013-028 2013-027 2013-026 Ethics Committee endorsement as an Authorised Prescriber of an unapproved product under section 19(5) of the Therapeutic Goods Act XL 184-308: A Phase 3 randomized, controlled study of Cabozantinib (XL 184) vs. Everolimus in subjects with metastatic renal cell carcinoma that has progressed after prior VEGFR Tyrosine Kinase Inhibitor Therapy Retrospective audit of the outcomes following oesophagectomy at Sydney Adventist Hospital Archived - Never Approved Archived - Withdrawn Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 28-Oct-2013 Approved Dr Stephanie Phillips Consultant Anaesthetist, Sydney Adventist Hospital Clinical School 406A San Clinic 185 Fox Valley Road Wahroonga NSW 2076 28-Oct-2013 Approved Comparison of kinemyography (KMG) with electromyography (EMG) for measurement of neuromuscular blockade during anaesthesia in humans Dr Paul Stewart AMO Consultant Anaesthesia 28-Oct-2013 Study Complete Survey of Practice of Induction of Labour in NSW Wales Hospitals Dr Tanya Nippita Lecturer, Sydney Medical School Northern The University of Sydney Sydney Medical School - Northern The University of Sydney Building 52, Level 2 Royal North Shore Hospital St Leonards NSW 2065 22-Oct-2013 Approved PO Box 82 Wahroonga NSW 2076 Updated 1-Sep-2014 2013-025 A phase 3, randomised, double-blind, controlled trial of Cabozantinib (XL184) vs Mitoxantrone plus Prednisone in men with previously treated symptomatic castrationresistant prostate cancer (COMET-2) MDV3100-14: PROSPER: A Multinational, Phase 3, Randomised, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Enzalutamide in Patients with Nonmetastatic Castration-Resistant Prostate Cancer Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 14-Oct-2013 Approved Associate Professor Henry Woo Australian Clinical Trials Pty Ltd Australian Clinical Trials Suite 406 San Clinic 185 Fox Valley Road Wahroonga NSW 2076 09-Oct-2013 Approved 2013-023 Evaluation of the 5:2 intermittent Energy Restriction (IER) diet Associate Professor Ross Grant CEO - Australasian Research Institute Chief Scientist Australasian Research Institute 185 Fox Valley Road Wahroonga NSW 2076 28-Oct-2013 Approved 2013-022 Correlation of modifiable lifestyle factors to markers of oxidative stress and inflammation; application to the development of a clinically relevant 'wellness' diagnostic score Associate Professor Ross Grant CEO - Australasian Research Institute Chief Scientist Australasian Research Institute 185 Fox Valley Road Wahroonga NSW 2076 28-Oct-2013 Approved 2013-021 CO.23: A Phase III randomised study of BB1608 and best supportive care versus placebo and best supportive care in patients with pretreated advanced colorectal carcinoma Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 07-Aug-2013 Archived - Discontinued 2013-020 The evaluation of post-graduate training and welfare of medical intern workforce in the private health sector Dr June Strong Medical Services Coordinator Medical Services Coordinator Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 30-Jul-2013 Approved 2013-019 A three-arm, randomized, open label, phase II study of everolimus in combination with exemestane versus everolimus alone versus capecitabine in the treatment of postmenopausal women with estrogen receptor positive, locally advanced, recurrent, or metastatic breast cancer after recurrence or progression on prior letrozole or anastrozole [BOLERO] Clinical outcomes: Upper Extremity Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 29-Jul-2013 Approved Dr David Duckworth 116 Macquarie Street Parramatta NSW 2150 18-Jun-2013 Approved 2013-017 How effective is transdermal administration of Adenoysl cobalamin and Methyl cobalamin (biologically available analogues of vitamin B12) in the treatment and prevention of vitamin B12 deficiency? Dr Bevan Hokin Director of Pathology Pathology Director Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 18-Dec-2013 Approved 2013-016 ACORN: "Arthroplasty Clinical Outcomes Registry NSW" and incorporated sub-study "Improving services and outcomes for joint replacements" Nutritional intake of inpatients in an acute care private hospital post-trial implementation of an expanded midmeal menu service Professor Ian Harris 18-Jun-2013 Approved Ms Jodie Privett APD 23-May-2013 Approved 2013-024 2013-018 2013-015 Updated 1-Sep-2014 2013-014 Prostate cancer data set specification pilot project Associate Professor Henry Woo Australian Clinical Trials Pty Ltd Australian Clinical Trials Suite 406 San Clinic 185 Fox Valley Road Wahroonga NSW 2076 20-May-2013 Archived - Study Complete 2013-013 Contaminated waste segregation using the C64 clinical waste bin system (Clinismart) Ms Fiona DeSousa Infection Prevention & Control Coordinator 29-Apr-2013 Archived - Study Complete 24-Apr-2013 Approved Infection Prevention & Control Coordinator Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 2013-012 A Phase II, randomized study of Paclitaxel with GDC-0941 versus Paclitaxel with placebo in patients with locally recurrent or metastatic breast cancer (PEGGY) Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 2013-011 Impact of high-potency Omega-3 supplementation on Metabolic Disease Associate Professor Ross Grant CEO - Australasian Research Institute Chief Scientist Australasian Research Institute 185 Fox Valley Road Wahroonga NSW 2076 2013-010 Natural course of hot flash symptoms in men receiving AndrogenDeprivation Therapy for Prostate Cancer - A Pilot Investigation Associate Professor Henry Woo Australian Clinical Trials Pty Ltd Australian Clinical Trials Suite 406 San Clinic 185 Fox Valley Road Wahroonga NSW 2076 29-Apr-2013 Approved 2013-009 Does the timing of intraoperative NSAID improve pain outcomes following ureteroscopy? Dr Helen Nicholson Urology Registrar SAH Department of Urology Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 15-Mar-2013 Approved 2013-008 Master of Biostatistics research project: Statistical modelling of cholesterol and liver function tests by age, gender and time Associate Professor Gillian Heller Statistics Department Building E4A, Room 533 25-Feb-2013 Approved 25-Feb-2013 Approved Archived - Never Approved Macquarie University NSW 2109 2013-007 PEGASUS - Prevalence and severity of genito-urinary symptoms in women receiving adjuvant endocrine therapy for early stage breast cancer and their association with sexual dysfunction and impact on quality of life - A prospective study Dr Mariana Sousa Ob/Gyn, PhD Candidate Psychosocial Research Group Prince of Wales Hospital Dickinson Building, Level 3 2013-006 Initial interactions of Herpes Simplex virus with innate immune cells in human skin Dr Ralph Cohen SAN Clinic Sydney Adventist Hospital Fox Valley Road Wahroonga NSW 2076 29-Jan-2013 Approved 2013-005 Developing an antimicrobial stewardship model for Australian private hospitals Mr Menino Osbert Cotta 16-Jan-2013 Approved RANDWICK NSW 2031 Updated 1-Sep-2014 2013-004 Correlation of biophotonic skin carotenoid score with food frequency questionnaire: effects of biodemographic, biochemical and physiological parameters Associate Professor Ross Grant CEO - Australasian Research Institute Chief Scientist Australasian Research Institute 185 Fox Valley Road Wahroonga NSW 2076 06-Feb-2013 Approved 2013-003 A randomized, double-blind, comparative study of ZYTIGA (Abiraterone Acetate) plus low-dose Prednisone plus Androgen Deprivation Therapy (ADT) versus ADT alone in newly diagnosed subjects with highrisk, metastatic hormone-naive prostate cancer (mHNPC) (LATITUDE) Intravenous lignocaine infusion for analgesia following laparoscopic hiatus hernia repair: A double-blinded, randomised, placebo-controlled trial Associate Professor Henry Woo Australian Clinical Trials Pty Ltd Australian Clinical Trials Suite 406 San Clinic 185 Fox Valley Road Wahroonga NSW 2076 06-Feb-2013 Approved Dr Stephanie Phillips Consultant Anaesthetist, Sydney Adventist Hospital Clinical School 406A San Clinic 185 Fox Valley Road Wahroonga NSW 2076 27-Mar-2013 Archived - Discontinued 2013-001 Are private hospitals suitable training sites for prevocational trainees? A study of patient satisfaction Ms Marilyn Algeo MO and Resident Services Manager | Medical Services Medical Services Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 17-Dec-2012 Approved 2012-033 VRTC Protocol No: ADX11080 - A Non-Interventional Follow-Up to the Velour study (multicentre International Study of Aflibercept versus placebo in combination with FOLFIRI for metastatic colorectal cancer) Translational Research Melanoma Institute Australia Biospecimen bank for melanoma research Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 10-Dec-2012 Withdrawn Associate Professor Michael Hughes Northern Surgical Oncology San Clinic Suite 404 185 Fox Valley Road Wahroonga NSW 2076 12-Nov-2012 Approved XL184-307: Phase 3 randomised double blind controlled study of Cabozanatinib (XL184) vs Prednisone in metastatic castration resistant prostate cancer patients who have received prior Docetaxel and prior Abiraterone or MDV3100 (COMET) Implementation of an expanded midmeal menu service in an acute care private hospital and its impact on patients' nutritional intake and cost Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 29-Oct-2012 Approved Ms Jodie Privett Nutrition & Dietetics Department Sydney Adventist Hospital Wahroonga NSW 2076 29-Oct-2012 Approved 2012-029 Evaluation of the Integration of carer knowledge to improve inpatient care for dementia patients (TOP 5) Dr Karen Luxford Director, Patient Based Care Clinical Excellence Commission L 13, 227 Elizabeth Street Sydney NSW 2000 12-Nov-2012 Approved 2012-028 GU09-145: Phase I/II Study of BNC105P in Combination with Everolimus or Following Everolimus for Progressive Metastatic Clear Cell Renal Cell Carcinoma Following Prior Tyrosine Kinase Inhibitors Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 08-Oct-2012 Approved 2013-002 2012-032 2012-031 2012-030 Updated 1-Sep-2014 2012-027 FINESSE trial - Filtration in the Neuropathy of End Stage Kidney Disease Symptom Evolution. A randomised, unblinded, controlled trial to assess progression of neuropathy with haemodiafiltration vs standard haemodialysis in patients with endstage kidney disease. Data collection on outcomes on men with prostate cancer treated with radical prostatectomy Dr Meg Jardine The George Institute for Global Health PO Box M201 Missenden Road Camperdown NSW 2050 15-May-2013 Approved Associate Professor Henry Woo Australian Clinical Trials Pty Ltd Australian Clinical Trials Suite 406 San Clinic 185 Fox Valley Road Wahroonga NSW 2076 22-Oct-2012 Approved 2012-025 Data collection on outcomes on men treated with greenlight laser surgery Associate Professor Henry Woo Australian Clinical Trials Pty Ltd Australian Clinical Trials Suite 406 San Clinic 185 Fox Valley Road Wahroonga NSW 2076 10-Oct-2012 Approved 2012-024 A phase III study of the impact of a physical activity program on diseasefree survival in patients with high risk stage II or stage III colon cancer: a randomised controlled trial (CHALLENGE) Living Well with Prostate Cancer: A Randomised Controlled Trial of a Mindfulness Intervention for Men with Advanced Prostate Cancer Development of Smart Phone application for neuromuscular function monitoring Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 26-Sep-2012 Approved Professor Suzanne Chambers 553 Gregory Terrace Fortitude Valley Qld 4006 26-Sep-2012 Approved Dr Stephanie Phillips Consultant Anaesthetist, Sydney Adventist Hospital Clinical School 406A San Clinic 185 Fox Valley Road Wahroonga NSW 2076 26-Sep-2012 Approved 2012-021 An international survey on what constitutes a large prostate Associate Professor Henry Woo Australian Clinical Trials Pty Ltd Australian Clinical Trials Suite 406 San Clinic 185 Fox Valley Road Wahroonga NSW 2076 04-Sep-2012 Approved 2012-020 An Australian Translational Study to Evaluate the Prognostic Role of Inflammatory Markers in Patients with Metastatic Colorectal Cancer Treated with Bevacizumab (Avastin) [ASCENT] Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 05-Aug-2012 Approved 2012-019 FDC116115: A prospective study of sexual function in sexually active men treated for BPH Associate Professor Henry Woo Australian Clinical Trials Pty Ltd Australian Clinical Trials Suite 406 San Clinic 185 Fox Valley Road Wahroonga NSW 2076 28-Nov-2012 Approved 2012-018 Has the introduction of baby friendly caesarean section influenced breast feeding rates at one and three months post-natally? A/Prof John Keogh 304 SAN Clinic 85 Fox Valley Road WAHROONGA NSW 2076 2012-017 Can NSW Admitted Patient Data improve the quality and coverage of the NSW Register of Congenital Conditions? Dr Lee Taylor Locked Bag 961 NSW Ministry of Health Surveillance Methods Branch, Centre of Epidemiology and Research North Sydney NSW 2059 2012-026 2012-023 2012-022 Archived - Never Approved 24-Jul-2012 Approved Updated 1-Sep-2014 2012-016 A phase II, double-blind, placebo controlled, randomized study of GDC0941 or GDC-0980 with fulvestrant versus fulvestrant in advanced or metastatic breast cancer in patients resistant to aromastase inhibitor therapy (FERGI) Involving relatives in the care of a patient in the ICU setting; What factors impact on this? Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 09-Jul-2012 Recruitment Ceased Dr Tracey Thornley Supervisor Dean, School of Nursing Sydney The University of Notre Dame PO Box 944 Broadway NSW 2077 04-Jul-2012 Archived - Study Complete The successfulness of ultrasound guided removal of a Mirena device when the strings are not visible on speculum examination in an outpatient setting (A retrospective review of cases) A multi-centre randomized controlled trial of early goal-directed therapy in patients presenting to the Emergency Department with severe sepsis in Australasia Dr Karen Mizia San Ultrasound for Women Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 30-Apr-2012 Study Complete Dr Roger Harris Staff Specialist, Intensive Care, Sydney Adventist Hospital, 185 Fox Valley Road Wahroonga NSW 2076 16-May-2012 Archived - Study Complete A randomised, open label, multicentre, Phase IIIB study comparing two Trastuzumab dosing regimens, each in combination with Ciplatin/Capecitabine chemotherapy, as first line therapy in patients with HER2-positive metastatic gastric or gastro-oesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease (HELOISE) Assessment of spinal sagittal balance parameters with EOS imaging Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 12-Mar-2012 Study Complete Dr Peter Wilson Neurosurgical trainee 1/241-245 Avoca Street Randwick NSW 2031 18-Jun-2012 Approved 2012-010 Promotion of health lifestyle and risk modification for cancer survivors and their partners / caregivers (ENRICH: Exercise and Nutrition Routine Improving Cancer Health) Dr Erica James School of Medicine & Public Health Faculty of Health Level 2, David Maddison Building Callaghan NSW 2308 12-Mar-2012 Approved 2012-009 Survey of nursing attitudes to residual neuromuscular blockade and reversal Dr Paul Stewart AMO Consultant Anaesthesia 05-Mar-2012 Approved Jade Guest 28-Mar-2012 Approved Mr Dallas O'Connor Associate Director of Safe Place Services Seventh-day Adventist Church (AUC) Ltd PO Box 650 Wahroonga NSW 2076 12-Mar-2012 Approved Professor Christine Clarke Westmead Millennium Institute Darcy Road Westmead NSW 2145 20-Mar-2012 Approved 2012-015 2012-014 2012-013 2012-012 2012-011 PO Box 82 Wahroonga NSW 2076 2012-008 2012-007 The effect of high potency Omega-3 (Omacor) on markers of oxidative stress and inflammation Understanding clergy-parishioner relationships in local congregational settings - a qualitative analysis Phase 1 2012-006 Progesterone action in the human breast 2012-005 Prospective Evaluation of Various Uterine Prolapse Surgical Techniques in Nepalii Women A retrospective analysis of outcomes following abdominal hysteropexy for uterine prolapse in Nepal (Maharati 1) 2012-004 Archived - Withdrawn Archived - Withdrawn Updated 1-Sep-2014 2012-003 The Study of Heart and Renal Protection - Extended Review SHARP-ER Dr Meg Jardine The George Institute for Global Health PO Box M201 Missenden Road Camperdown NSW 2050 23-Apr-2012 Approved 2012-002 Designing a Prototype Clinical Information System (CIS) for Multidisciplinary Teams During Clinical Handover in Palliative Oncology Chris Williams Chief Information Officer Sydney Adventist Hospital 185 Fox Valley Rd 16-Jan-2012 Approved Wahroonga NSW 2076 2012-001 Safety and Feasibility of a Transurethral Endoscopic Procedure for the Luminal Restoration of the Prostatic Urethra: A Preliminary Investigation Associate Professor Henry Woo Australian Clinical Trials Pty Ltd Australian Clinical Trials Suite 406 San Clinic 185 Fox Valley Road Wahroonga NSW 2076 02-Feb-2012 Approved 2011-043 Evaluating the utility of a patient decision aid for prospective participants in the TROG RAVES prostate cancer trial. Associate Professor Henry Woo Australian Clinical Trials Pty Ltd Australian Clinical Trials Suite 406 San Clinic 185 Fox Valley Road Wahroonga NSW 2076 30-Jan-2012 Approved 2011-042 The complexity of treating women with breast cancer, who have underlying mental health issues. Changing the system to increase the adoption of "clot busters" in stroke treatment (TIPS) Ms Catrina Ross McGrath Breast Care Nurse 05-Dec-2011 Approved Professor John Watson Associate Dean Sydney Adventist Hospital Clinical School 28-Mar-2012 Approved 2011-040 Evaluation of a 12 week Yoga Intervention on Negative Affective States, Cardiovascular and Cognitive Function in Post-Cardiac Rehabilitation Patients Prof Hosen Kiat Medical Director SAH Cardiac Rehabilitation Program Cardiac Health Institute 173 Shaftsbury Road Eastwood NSW 2122 13-Feb-2012 Approved 2011-039 Characterization of the acute postprandial effect of energy dense foods on key markers of oxidative stress and inflammation Associate Professor Ross Grant CEO - Australasian Research Institute Chief Scientist Australasian Research Institute 185 Fox Valley Road Wahroonga NSW 2076 16-Jan-2012 Approved 2011-038 Arm-to-arm variation when evaluating neuromuscular block: An analysis of the precision and the bias and agreement between arms when using Electromyography in abductor digiti minimi and first dorsal Interosseous. Dr Paul Stewart AMO Consultant Anaesthesia 10-Oct-2011 Archived - Study Complete Arm-to-arm variation when evaluating neuromuscular block: An analysis of the precision and the bias and agreeement between arms when using Kinemyography Dr Paul Stewart AMO Consultant Anaesthesia Retrospective Audit of Post-Operative Analgesia after Ivor Lewis Oesophagogastrectomy Dr Stephanie Phillips Consultant Anaesthetist, Sydney Adventist Hospital Clinical School 406A San Clinic 185 Fox Valley Road Wahroonga NSW 2076 2011-041 2011-037 2011-036 PO Box 82 Wahroonga NSW 2076 Archived - Study Complete PO Box 82 Wahroonga NSW 2076 17-Oct-2011 Approved Updated 1-Sep-2014 2011-035 Randomized, open Label Multi-Centre Study Comparing Cabazitaxel at 20mg/m2 and at 25 mg/m2 Every 3 weeks in Combination with Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated with Docetaxel Containing Regimen (PROSELICA). Randomized, Open Label, MultiCentre, Study comparing Cabazitaxel at 25 mg/m2 and at 20 mg/m2 in Combination with Prednisone Every 3 Weeks to Docetaxel in Combination with Prednisone in Patients with Metastatic Castration Resistant Prostate Cancer not Pre-treated with Chemotherapy (FIRSTANA) A randomized, double-blind, placebocontrolled, parallel group, multicenter study to evaluate cardiovascular outcomes during treatment with Lixisenatide in type 2 diabetic patients after an Acute Coronary Syndrome. A phase III multi-centre, randomised trial comparing adjuvant radiotherapy (RT) with early salvage RT in patients with positive margins or extraprostatic disease following radical prostatectomy (RAVES) Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 12-Sep-2011 Recruitment Ceased Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 12-Sep-2011 Recruitment Ceased Dr Greg Fulcher 12-Sep-2011 Approved Dr Amy Teh Consultant in Radiation Oncology Radiation Oncology Institute Radiation Oncology Institute 185 Fox Valley Road Wahroonga NSW 2076 30-Oct-2011 Approved 2011-031 To investigate the ten year retreatment rate after bladder neck incision (BNI) or transurethral incision of the prostate (TUIP) for outlet obstruction. Associate Professor Henry Woo Australian Clinical Trials Pty Ltd Australian Clinical Trials Suite 406 San Clinic 185 Fox Valley Road Wahroonga NSW 2076 05-Sep-2011 Approved 2011-030 Clinical study to evaluate a scaffold implant for rotator cuff lesions encountered on the supraspinatus tendon (CIRCLES) Associate Professor Desmond Bokor Principal Investigator - SAH Specialty Orthopaedics 116 Macquarie Street Parramatta NSW 2150 05-Sep-2011 Approved 2011-029 An open label study of Abiraterone Acetate in subjects with metastatic castration-resistant prostate cancer who have progressed after Taxanebased chemotherapy. Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 04-Jul-2011 Study Complete 2011-028 Incidence of residual neuromuscular blockade in Australian post anaesthetic care units Dr Paul Stewart AMO Consultant Anaesthesia 18-Feb-2011 Approved Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 20-Jun-2011 Approved Associate Professor Ross Grant CEO - Australasian Research Institute Chief Scientist Australasian Research Institute 185 Fox Valley Road Wahroonga NSW 2076 29-Aug-2011 Approved 2011-034 2011-033 2011-032 PO Box 82 Wahroonga NSW 2076 2011-027 2011-026 A Phase 3, Randomized, Double-blind, Multicenter Trial Comparing Orteronel (TAK-700) Plus Prednisone With Placebo Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer that has progressed During or Following Docetaxel-based Therapy. The pharmacokinetic differences in serum and saliva levels of resveratrol, lycopene complex, NAD+ and oxidative stress. Updated 1-Sep-2014 2011-025 Do whole and/or highly processed foods or food ingredients promote adverse physiological responses? Associate Professor Ross Grant CEO - Australasian Research Institute Chief Scientist Australasian Research Institute 185 Fox Valley Road Wahroonga NSW 2076 2011-024 Improving psychosocial outcomes for carers of people with cancer: a randomised controlled trial Dr Joanne Shaw Surgical Outcomes Research Centre Building 89 Level 9 PO Box M157 Missenden Road NSW 2050 20-Jun-2011 Approved 2011-023 A Phase 3, randomized, double-blind trial of Pegylated Liposomal Doxorubicin (PLD) plus AMG 386 or placebo in women with recurrent partially platinum sensitive or resistant epithelial ovarian, primary peritoneal or fallopian tube cancer. Direct intra-patient comparison of evoked electromyography and acceleromyography during induced neuromuscular blockade in anaesthetised humans. Dr Joseph Rutovitz San Clinical Trials Unit Adventist HealthCare Limited 185 Fox Valley Road Wahroonga NSW 2076 13-Jun-2011 Approved Dr Paul Stewart AMO Consultant Anaesthesia 14-Jun-2011 Approved Direct intra-patient comparison of evoked electromyography and kinemyography during induced neuromuscular blockade in anaesthetised humans. Dr Paul Stewart AMO Consultant Anaesthesia 14-Jun-2011 Approved 2011-020 Comparison of evoked electromyographic responses in three different muscle groups of the hand following induced muscle relaxation in humans under general anaesthesia. Dr Stephanie Phillips Consultant Anaesthetist, Sydney Adventist Hospital Clinical School 406A San Clinic 185 Fox Valley Road Wahroonga NSW 2076 14-Jun-2011 Study Complete 2011-019 Comparison of gastric volumes and pH in lean and obese patients, determined by endoscopy. Dr Stephanie Phillips Consultant Anaesthetist, Sydney Adventist Hospital Clinical School 406A San Clinic 185 Fox Valley Road Wahroonga NSW 2076 14-Jun-2011 Approved 2011-018 PREVAIL: A multinational Phase 3, randomized, double-blind placebocontrolled efficacy and safety study of oral MDV3100 in chemotherapy-naive patients with progressive metastatic prostate cancer who have failed androgen deprivation therapy (MDV3100-03) Current practice of neuro-muscular blockade in Australia. A crosssectional survey of attitudes and practice of anaesthetists in 2011. Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 30-May-2011 Recruitment Ceased Dr Stephanie Phillips Consultant Anaesthetist, Sydney Adventist Hospital Clinical School 406A San Clinic 185 Fox Valley Road Wahroonga NSW 2076 06-Jun-2011 Study Complete 2011-016 Bi-National Colorectal Cancer Audit Dr Stuart Pincott 06-Jun-2011 Approved 2011-015 Multicentre, single-arm, open label, clinical trial intended to provide early access to Cabazitaxel in patients with metastatic hormone refractory prostate cancer previously treated with a Docetaxel-containing regimen and to document safety of Cabazitaxel in Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 09-May-2011 Study Complete 2011-022 2011-021 2011-017 Archived - Rejected PO Box 82 Wahroonga NSW 2076 PO Box 82 Wahroonga NSW 2076 Updated 1-Sep-2014 these patients (Cabazitaxel clinical trial) 2011-014 Phase II study to investigate the ability of macrophage inhibitory cytokine-1 (MIC-1) and associated plasma biomarkers to predict response to chemotherapy in patients with metastatic hormone-refractory prostate cancer. The Australian diabetes, obesity and lifestyle study Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 19-Apr-2011 Approved Dr Elizabeth Barr Epidemiologist Baker IDI Heart & Diabetes Institute Tues/Frid 20-Apr-2011 Approved 2011-012 Attitudes of SAN community to clinical student teaching in a private hospital setting Dr Stephanie Phillips Consultant Anaesthetist, Sydney Adventist Hospital Clinical School 406A San Clinic 185 Fox Valley Road Wahroonga NSW 2076 11-Apr-2011 Study Complete 2011-011 Porto Cath insertion Dr Sumit Lumba Medical Oncology Advanced Trainee under Dr Eisen Liang and Dr Gavin Marx 2011-010 Grounded theory research investigating organisational change in specified Australian hospitals to determine the applicability of existing generic organisational change management models to the not-forprofit hospital environment. Randomised controlled double-blind trial of targeted intra-crural ropivicaine for post-operative analgesia after laparoscopic fundoplication. Prof Elizabeth More PhD Supervisor 2011-008 A pilot study to evaluate a new blood test for the detection of prostate cancer using antibody arrays. Associate Professor Henry Woo Australian Clinical Trials Pty Ltd Australian Clinical Trials Suite 406 San Clinic 185 Fox Valley Road Wahroonga NSW 2076 30-May-2011 Approved 2011-007 Rhinology Tissue Bank A/Prof Richard Harvey St Vincent's Hospital Sydney Ear Nose & Throat Clinic Sydney Ear Nose & Throat Clinic 354 Victoria Street Darlinghurst NSW 2010 11-Jul-2011 Approved 2011-006 Assessment of the effect of oral supplementation with resveratrol and/or lycopene on key markers of oxidative stress over time and skin health following acute UV exposure. Associate Professor Ross Grant CEO - Australasian Research Institute Chief Scientist Australasian Research Institute 185 Fox Valley Road Wahroonga NSW 2076 06-Jun-2011 Archived - Study Complete 2011-005 Quantification of key markers of oxidative stress and inflammation in human cerebrospinal fluid and correlation with diet, lifestyle and psychosocial factors across the age range: Part 2. Associate Professor Ross Grant CEO - Australasian Research Institute Chief Scientist Australasian Research Institute 185 Fox Valley Road Wahroonga NSW 2076 24-May-2011 Approved 2011-013 2011-009 Archived - Study Complete 30-May-2011 Dr Stephanie Phillips Consultant Anaesthetist, Sydney Adventist Hospital Clinical School 406A San Clinic 185 Fox Valley Road Wahroonga NSW 2076 Approved Archived - Abandoned Updated 1-Sep-2014 2011-004 Incidence and management of capnothorax during laparoscopic massive hiatus hernia repair. 2011-003 No study submitted 2011-002 Patterns of care in patients with pancreatic cancer (POCS Pancreas NSW). Dr Stephanie Phillips Consultant Anaesthetist, Sydney Adventist Hospital Clinical School 406A San Clinic 185 Fox Valley Road Wahroonga NSW 2076 21-Feb-2011 Study Complete Archived - Never Approved Prof Dianne O’Connell Senior Epidemiologist, Cancer Council NSW 25-Jan-2011 Approved Cancer Council PO Box 572 Kings Cross NSW 1340 2011-001 Cell type specific biologic responses to HIV infection Professor Anthony Cunningham Westmead Millennium Institute Westmead Millennium Institute for Medical Research PO Box 412 Westmead NSW 2145 19-Jan-2011 Approved 28/10 Study to assess the incidence and efficacy of treatment of Helicobacter pylori infection in a representative population from the Gyuto Monastery in Northern India. Associate Professor Ross Grant CEO - Australasian Research Institute Chief Scientist Australasian Research Institute 185 Fox Valley Road Wahroonga NSW 2076 08-Dec-2010 Archived - Study Complete 27/10 A randomized, multicentre, open-label, Phase 3 study to compare the efficacy and safety of Panitumumab and Cetuximab in subjects with previously treated, wild-type KRAS, metastatic colorectal cancer. Establishment of a neuro and endocrine tumour and tissue bank within the Department of Cancer Genetics, Kolling Institute and the University of Sydney Endocrine Surgical Unit. Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 10-Dec-2010 Study Complete Professor Bruce Robinson The University Clinic Wallace Freeborn Professorial Block, Royal North Shore Hospital St Leonards NSW 2065 13-Dec-2010 Approved 25/10 Age related changes in NAD+ metabolism, oxidative stress and Sirtuin activity in human muscle. Associate Professor Ross Grant CEO - Australasian Research Institute Chief Scientist Australasian Research Institute 185 Fox Valley Road Wahroonga NSW 2076 08-Dec-2010 Archived - Study Complete 24/10 A prospective non-interventional study to evaluate the effect of Triptorelin Embonate (Diphereline 11.25mg) on lower urinary tract symptoms (LUTS) in Australian prostate cancer patients. Associate Professor Henry Woo Australian Clinical Trials Pty Ltd Australian Clinical Trials Suite 406 San Clinic 185 Fox Valley Road Wahroonga NSW 2076 25-Jan-2011 Approved 23/10 PREVAIL: A multinational Phase 3, randomized, double-blind, placebocontrolled efficacy and safety study of oral MDV3100 in chemotherapy-naïve patients with progressive metastatic prostate cancer who have failed androgen deprivation therapy (MDV3100-03) Identification of plasma biomarkers of therapeutic response in men with metastatic castrate-resistant prostate cancer (Biomarkers in Metastatic CRPC) Associate Professor Henry Woo Australian Clinical Trials Pty Ltd Australian Clinical Trials Suite 406 San Clinic 185 Fox Valley Road Wahroonga NSW 2076 02-Feb-2011 Approved Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 05-Sep-2010 Approved 26/10 22/10 Updated 1-Sep-2014 21/10 Cancer multidisciplinary team research project. Dr Genevieve Baratiny Visiting Research Fellow Discipline of General Practice, University of Adelaide North Terrace SA 5005 22-Sep-2010 Approved 20/10 A randomized, double-blind, placebocontrolled, multi-centre phase 3 study of Denosumab as adjuvant treatment for women with early-stage breast cancer at high risk of recurrence (DCare) Advisa Dr MRI pacing system clinical study. Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 23-Aug-2010 Recruitment Ceased 18/10 Modular-choice secondary prevention following acute coronary syndrome: a randomised multicentre trial. Dr Julie Redfern Senior Research Fellow The George Institute for Global Health, PO Box M201 Missenden Road NSW 2050 15-Jul-2010 Approved 17/10 Pilot study to assess the efficacy of naturally enhanced soy powder to reduce fasting blood glucose levels in humans. Associate Professor Ross Grant CEO - Australasian Research Institute Chief Scientist Australasian Research Institute 185 Fox Valley Road Wahroonga NSW 2076 30-Jun-2010 Study Complete 16/10 A multicentre, controlled trial to determine the safety and efficacy of hypertensive extracorporeal limb perfusion (HELP) in treating patients with critical limb ischaemia. Improved cord blood stem cell recovery through the characterization of upstream factors contributing to final post thaw viability – Part II. Professor Rodney Lane Suite 13 Greenwich Square, 130-134 Pacific Highway St Leonards NSW 2065 30-Jun-2010 Archived - Discontinued Belinda Pope Quality Manager Stem Cell Unit, L5 Pathology, Sydney Adventist Hospital, 185 Fox Valley Road Wahroonga NSW 2076 30-Jun-2010 Approved 14/10 Clinical results of dynamic hip screws versus proximal femoral nails for intratrochanteric fractures. A/Prof Nigel Hope Suite 11, 4 Young St Neutral Bay NSW 2089 08-Jun-2010 Approved 13/10 Assessment of senior adults in oncology. A prospective audit of clinical practice in Australian oncology units. Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 31-May-2010 Approved 12/10 Establishing the factors that contribute to a shortfall in evidence-based radiotherapy. Prof Geoff Delaney Director Radiation Oncology, Western Zone, Sydney South West Area Health Service Liverpool Hospital Cancer Therapy Centre, Locked Bag 7103 Liverpool BC NSW 1871 24-May-2010 Approved 11/10 A Randomized Double-Blind Phase 3 Trial Comparing Docetaxel Combined with Dasatinib to Docetaxel Combined with Placebo in Castration-Resistant Prostate Cancer. Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 03-May-2010 Discontinued 19/10 15/10 Dr Peter Illes 502 San Clinic 185 Fox Valley Road Wahroonga NSW 2076 Archived - Rejected Updated 1-Sep-2014 10/10 The impact of San Day Infusion Centre treatment on the experience of pain, anxiety, nausea and fatigue in cancer patients. Ms Anne Temblett Director of Medical Care Services (Nursing) 185 Fox Valley Road Wahroonga NSW 2076 23-Apr-2010 Approved 09/10 Consumer perspectives regarding dialysis treatment. Dr Paul Collett Director of Nephrology Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 13-Apr-2010 Approved 08/10 Validation study of recurrent postpartum haemorrhage and associated factors as reported in the admitted patient data collection and midwives data collections 2002-2006 (validated against medical records). Dr Jane Ford University of Sydney, Dept of Obstetrics & Gynaecology, Level 2, Building 52, Royal North Shore Hospital St Leonards NSW 2065 15-Jun-2010 Approved 07/10 Patient Journey Review Lillian Stibbs Quality Management Officer, San Day Surgery Hornsby, c/o 22 Moolanda Avenue West Pennant Hills NSW 2126 29-Mar-2010 Approved 06/10 Prayer request form study Ms Kristina Mazzaferri Senior Chaplain Sydney Adventist Hospital, 185 Fox Valley Road Wahroonga NSW 2076 29-Mar-2010 Approved 05/10 Improved cord blood stem cell recovery through the characterization of upstream factors contributing to final post thaw viability. Belinda Pope Quality Manager Stem Cell Unit, L5 Pathology, Sydney Adventist Hospital, 185 Fox Valley Road Wahroonga NSW 2076 26-Feb-2010 Approved 04/10 A multi-centre, prospective controlled trial on the incidence of retrograde ejaculation post photoselective vaporisation prostatectomy (PVP) compared to diathermy transurethral resection of the prostate (TURP). Associate Professor Henry Woo Australian Clinical Trials Pty Ltd Australian Clinical Trials Suite 406 San Clinic 185 Fox Valley Road Wahroonga NSW 2076 24-Mar-2010 Approved 03/10 The IMPACT of Biotronik home monitoring guided anticoagulation on stroke risk in patients with ICD and CRT-D devices. Dr Peter Illes 502 San Clinic 185 Fox Valley Road Wahroonga NSW 2076 30-Jun-2010 Archived - Discontinued 02/10 Health-related outcomes of valve surgery for rheumatic heart disease performed by a volunteer humanitarian team in Fiji. Dr Robyn Gallagher University of Technology, Sydney University of Technology Level 7, Building 10 City Campus PO Box 123 03-Feb-2010 Approved 30-Jun-2010 Approved BROADWAY NSW 2007 01/10 A preliminary investigation into primary causes of oxidative stress in the brain and its impact on vital neuronal cell biochemistry. Associate Professor Ross Grant CEO - Australasian Research Institute Chief Scientist Australasian Research Institute 185 Fox Valley Road Wahroonga NSW 2076 Updated 1-Sep-2014 25/09 Ovarian cancer patterns of care survey – NSW A/Prof Penelope Webb Queensland Institute of Medical Research, Cancer & Population Studies Unit, PO Royal Brisbane Women’s Hospital Herston QLD 4029 14-Dec-2009 Approved 24/09 AG0507GS: A multicentre phase II study of Risk Evaluation in GIST with Selective Therapy Escalation for Response. (REGISTER) Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 30-Nov-2009 Archived - Discontinued 23/09 Cancer incidence in recipients of haematopoietic stem cell transplantation in Australia Dr Lesley Ashton Children’s Cancer Institute Australia, PO Box 81 Randwick NSW 2032 01-Dec-2009 Approved 22/09 Investigation into the effect of patient body habitus on quality of mesorectal resection in rectal cancer. A Phase 3, randomized, double-blind, placebo-controlled study of Abiraterone Acetate (CB7630) plus Prednisone in asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer (COUGAR-AA-302) Case studies with muscle relaxants reversal agents. Dr Adrian Smith 09-Nov-2009 Approved Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 04-Nov-2009 Recruitment Ceased Dr Paul Stewart AMO Consultant Anaesthesia 27-Oct-2009 Approved 21/09 20/09 PO Box 82 Wahroonga NSW 2076 19/09 The Australian Maternity Outcomes Surveillance System (AMOSS): Improving the safety and quality of maternity care in Australia. Professor Elizabeth Sullivan Associate Dean (Research) University of Technology, Sydney, Faculty of Health Faculty of Health University of Technology, Sydney Broadway NSW 2077 10-Mar-2010 Approved 18/09 Pilot study to assess the incidence and efficacy of treatment of Helicobacter pylori infection in a representative population from the Gyuto Monastery in Northern India. Associate Professor Ross Grant CEO - Australasian Research Institute Chief Scientist Australasian Research Institute 185 Fox Valley Road Wahroonga NSW 2076 14-Oct-2009 Archived - Study Complete 17/09 Early parenteral nutrition versus standard care in the critically ill patient: A level I randomised controlled trial. Dr Roger Harris Staff Specialist, Intensive Care, Sydney Adventist Hospital, 185 Fox Valley Road Wahroonga NSW 2076 14-Oct-2009 Archived - Study Complete 16/09 A double-blind, placebo-controlled study to evaluate new or worsening lens opacifications in subjects with non-metastatic prostate cancer receiving Denosumab for bone loss due to androgen-deprivation therapy. Associate Professor Henry Woo Australian Clinical Trials Pty Ltd Australian Clinical Trials Suite 406 San Clinic 185 Fox Valley Road Wahroonga NSW 2076 14-Oct-2009 Approved 15/09 A Phase III, randomised, placebocontrolled, double-blind study to assess the efficacy and safety of onedaily orally administered ZD4054 10mg in non-metastatic hormoneresistant prostate cancer patients. Associate Professor Henry Woo Australian Clinical Trials Pty Ltd Australian Clinical Trials Suite 406 San Clinic 185 Fox Valley Road Wahroonga NSW 2076 14-Oct-2009 Archived - Study Complete Updated 1-Sep-2014 14/09 A double-blind, randomised, multiple dose, phase III, multicentre study of Alpharadin in the treatment of patients with symptomatic hormone refractory prostate cancer with skeletal metastases. Associate Professor Henry Woo Australian Clinical Trials Pty Ltd Australian Clinical Trials Suite 406 San Clinic 185 Fox Valley Road Wahroonga NSW 2076 14-Oct-2009 Archived - Study Complete 12/09 A prospective, randomized, doubleblind, placebo-controlled Phase III study of Modafinil to improve fatigue and quality of life (QOL) in patients treated with Docetaxel-based chemotherapy for metastatic breast or prostate cancer – MOTIF (Modafinil in Taxotere® - Induced Fatigue). Botox injection for treatment of chronic prostate pain Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 14-Aug-2009 Archived - Study Complete 10/09 The NSW Cancer, Lifestyle and Evaluation of Risk (CLEAR) study. Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 27-Jul-2009 Archived - Study Complete 09/09 Continuous ST segment monitoring and incidence of clinical events in ICD patients – AnalyST Registry Dr Peter Illes 502 San Clinic 185 Fox Valley Road Wahroonga NSW 2076 06-Jul-2009 Archived - Abandoned 08/09 An observational, multicentre, open label, non-interventional programme to assess the long-term safety and efficacy of Somatuline® Autogel® in the treatment of NET when administered by patients or their partners (“home injection group”) or administered by healthcare professionals. Prediction of cardiotoxicity by measurement of serum N-terminal proB-type natriuretic peptide levels in breast cancer patients receiving adjuvant Trastuzumab (CATS) Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 06-Jul-2009 Archived - Study Complete Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 08-Jun-2009 Approved A Phase Ib/II study to assess the safety and efficacy of AMG102 in combination with Mitoxantrone and Prednisone in subjects with previously treated castrate resistant prostate cancer (AMG102) A multi-centre, randomized, doubleblind, phase 3 study of sunitinib plus prednisone versus prednisone in patients with progressive metastatic hormone-refractory prostate cancer after failure of a docetaxel-based chemotherapy regimen. Characterisation of the effect of polyphenol fortified red grape juice on markers of oxidative stress and redox potential in healthy human subjects. Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 11-May-2009 Archived - Study Complete Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 11-May-2009 Archived - Study Complete Ms Hemani Trevidi Dept Pharmacology, University of NSW, 203 Wallace Wurth Building 13-May-2009 Archived - Study Complete Consumer Forums conducted by Marketing, Communications & Business Development Unit Ms Julie Behrens Group Director Marketing & Business Development 18-Mar-2009 Approved 11/09 07/09 06/09 05/09 04/09 03/09 Associate Professor Henry Woo Australian Clinical Trials Pty Ltd Australian Clinical Trials Suite 406 San Clinic 185 Fox Valley Road Wahroonga NSW 2076 Adventist HealthCare Limited 185 Fox Valley Road Wahroonga NSW 2076 Archived - Abandoned Updated 1-Sep-2014 02/09 01/09 33/08 32/08 31/08 30/08 29/08 28/08 27/08 26/08 ACTIVE dialysis – A Clinical Trial of IntensiVE Dialysis. A multicentre, unblended, randomised, controlled trial to assess quality of life, clinical outcomes and cost utility for extended vs standard duration of dialysis in patients with end stage kidney disease Long-term follow-up of efficacy of transurethral resection of the prostate. Dr Paul Collett Director of Nephrology Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 01-Jul-2009 Study Complete Associate Professor Henry Woo Australian Clinical Trials Pty Ltd Australian Clinical Trials Suite 406 San Clinic 185 Fox Valley Road Wahroonga NSW 2076 22-Mar-2009 Archived - Study Complete A multicentre, open-label, randomised, phase III trial comparing immediate adjuvant hormonal therapy (Eligard – leuprolide acetate)) in combination with Taxotere (cocetaxel) administered every three weeks versus hormonal therapy alone versus deferred therapy followed by the same therapeutic options in patients with prostate cancer at high risk of relapse after radical prostatectomy. A phase III randomised study of Brivanib Alaninate (BMS 582664) in combination with Cetuximab (Erbitux, C225) versus placebo in combination with Cetuximab in patients previously treated with combination chemotherapy for metastatic colorectal carcinoma. A randomized, double-blind, multicentre study of denosumab compared with zoledronic acid (Zometa) in the treatment of bone metastases in subjects with advanced breast cancer. A Phase III, randomised, double-blind study to assess the efficacy and safety of 10mg ZD4054 versus placebo in patients with hormone resistant prostate cancer and bone metastasis who are pain free or mildly symptomatic. RIBBON study – A Phase III multicentre, randomised, placebocontrolled trial evaluating the efficacy and safety of Bevacizumab in combination with chemotherapy regimens in subjects with previously treated metastatic breast cancer. A randomized, double-blind, multicentre, Phase III study to compare the efficacy and safety of AZD2171 when added to 5fluorouracil, leucovorin and oxaliplatin (FOLFOX) or capecitabine and oxaliplatin (XELOX) with the efficacy and safety of placebo when added to FOLFOX or XELOX in patients with previously untreated metastatic colorectal cancer. Protocol D8480C0051 A Phase 3, multicentre, randomized, placebo-controlled, double-blind trial of AMG 706 in combination with Paclitaxel and Carboplatin for advanced non-small cell lung cancer. Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 01-Apr-2008 Archived - Study Complete Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 01-Apr-2008 Archived - Study Complete Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 01-Apr-2008 Archived - Study Complete Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 01-Apr-2008 Archived - Study Complete Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 01-Apr-2008 Archived - Study Complete Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 01-Apr-2008 Archived - Study Complete Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 01-Apr-2008 Archived - Study Complete A multicentre, randomized, doubleblind study comparing the efficacy and safety of aflibercept versus placebo administered every 3 weeks in patients treated with Docetaxel/Prednisone for metastatic androgen-independent prostate cancer. Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 01-Apr-2008 Archived - Study Complete Updated 1-Sep-2014 25/08 24/08 23/08 22/08 21/08 20/08 19/08 18/08 17/08 16/08 15/08 A double-blind, randomised, multicentre, Phase III study of Bevacizumab in combination with Capecitabine and Cisplatin versus placebo in combination with Capecitabine and Cisplatin, as firstline therapy in patients with advanced gastric cancer. A phase III open label, randomized, two-parallel-arm multicentre study of E7389 versus Capecitabine in patients with locally advanced or metastatic breast cancer previously treated with anthracyclines and taxanes and refractory to the most recent chemotherapy. A randomised, double-blind, multicentre study of denosumab compared with zoledronic acid (Zometa) in the treatment of bone metastases in subjects with advanced cancer (Excluding breast and prostate cancer) or multiple myeloma. A randomized, double-blind, multicentre study of Denosumab compared with Zoledronic Acid (Zometa) in the treatment of bone metastases in men with hormone-refractory prostate cancer. A randomised, open-label, multicentre study to evaluate the efficacy and safety of Bevacizumab in combination with Trastuzumab/Docetaxel compared with Trastuzumab/Docetaxel alone as first line treatment for patients with HER2 positive locally recurrent or metastatic breast cancer. A randomised, multi-centre, Phase 3 study to compare the efficacy of panitumumab in combination with chemotherapy to the efficacy of chemotherapy alone in patients with previously treated metastatic colorectal cancer. A randomised double-blind, placebocontrolled, multi-centre Phase 3 study of Denosumab on prolonging bone metastasis-free survival in men with hormone- refractory prostate cancer. Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 01-Apr-2008 Archived - Study Complete Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 01-Apr-2008 Approved Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 01-Apr-2008 Archived - Study Complete Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 01-Apr-2008 Archived - Study Complete Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 01-Apr-2008 Approved Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 01-Apr-2008 Archived - Study Complete Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 01-Apr-2008 Archived - Study Complete A prospective, multicentre, randomized trial of carboplatin flat dosing versus intrapatient dose escalation in first line chemotherapy of ovarian fallopian tube and primary peritoneal cancers. A multinational, randomised, doubleblind study comparing the efficacy of Afibercept once every 2 weeks versus placebo in patients with metastatic colorectal cancer (MCRC) treated with Irinotecan / 5-FU combination (FOLFIRI) after failure of Oxaliplatin based regimen. Chronic cough without wheeze or shortness of breath in children may be caused by upper airway obstruction Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 01-Apr-2008 Archived - Discontinued Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 01-Apr-2008 Archived - Study Complete Dr Hugh Allen Dept of Paediatrics, Royal North Shore Hospital , Pacific Highway St Leonards NSW 2065 19-Dec-2008 Archived - Study Complete Influence of home monitoring on mortality and morbidity in heart failure patients with an impaired left ventricular function (IN-TIME) Dr Peter Illes 502 San Clinic 185 Fox Valley Road Wahroonga NSW 2076 28-Jan-2009 Archived - Study Complete Updated 1-Sep-2014 14/08 A randomised, double-blind, placebocontrolled, factorial-design trial to assess the effect of aspirin and fish oil (omega-3 fatty acids) in the prevention of early thrombosis in arterio-venous fistulae in patients with Stage IV or V chronic kidney disease requiring haemodialysis (FAVOURED) Temporal trends in incidence of primary brain tumours in the Australian Capital Territory and New South Wales: 1994 – 2008 Dr Paul Collett Director of Nephrology Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 03-Dec-2008 Approved Dr Vini Khurana Dept of Neurosurgery, The Canberra Hospital, PO Box 11 Woden ACT 2606 29-Jan-2009 Archived - Study Complete A randomized, double-blind, multicentre, phase II/III study to compare the efficacy of AZD2171 in combination with 5-fluorouracil, leucovorin and oxaliplatin (FOLFOX), to the efficacy of bevacizumab in combination with FOLFOX in patients with previously untreated metastatic colorectal cancer. Protocol No: D8480C00013 Haemostasis Registry Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 23-Oct-2008 Archived - Study Complete Prof Peter Cameron Haemostasis Registry, Dept of Epidemiology & Preventive Medicine, Monash University, The Alfred Hospital, Commercial Road Melbourne VIC 3004 10-Oct-2008 Archived - Study Complete 10/08 Optimal programming to improve mechanical indices, symptoms and exercise in cardiac resynchronization therapy (OPTIMISE CRT) Dr Peter Illes 502 San Clinic 185 Fox Valley Road Wahroonga NSW 2076 09/08 A phase II biomarker identification trial for Erlotinib (Tarceva) in patients with advanced pancreatic carcinoma. Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 10-Sep-2008 Archived - Study Complete 08/08 A phase II, dose escalation to rash trial of Erlotinib (Tarceva) plus Gemcitabine in patients with metastatic pancreatic cancer. Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 10-Sep-2008 Archived - Study Complete 07/08 Age at first birth, mode of conception and adjustment to parenthood. Dr Catherine McMahon Senior Lecturer Psychology Psychology Dept, Macquarie University North Ryde NSW 2109 03-Sep-2008 Archived - Study Complete 06/08 Neurobiological correlates of depression in adolescents. Associate Professor Ross Grant CEO - Australasian Research Institute Chief Scientist Australasian Research Institute 185 Fox Valley Road Wahroonga NSW 2076 27-Aug-2008 Archived - Study Complete 05/08 A phase 3 , randomised double-blind placebo controlled study of Abiratone Acetate (CB7630) plus prednisone in patients with metastatic castrationresistant prostate cancer who have failed Docetaxel-based chemotherapy. Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 14-Aug-2008 Archived - Study Complete 13/08 12/08 11/08 Archived - Withdrawn Updated 1-Sep-2014 04/08 Phase I, single-centre, randomised, placebo controlled, fixed dose clinical trial of the safety and efficacy of up to 14 days application of Zb extract cream in the treatment of subjects with common warts. Associate Professor Ross Grant CEO - Australasian Research Institute Chief Scientist Australasian Research Institute 185 Fox Valley Road Wahroonga NSW 2076 14-May-2008 Archived - Discontinued 03/08 To assess a level of satisfaction with PageWriter TC70 (VersionA.01.00) cardiograph and the Triton PIM lead set for its functionality and performance An international multi-centre openlabel 2-arm phase III trial of adjuvant Bevacizumab in triple negative breast cancer - BEATRICE Penman Director of Patient Flow Services Sydney Adventist Hospital 22-May-2008 Archived - Study Complete Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 09-Apr-2008 Recruitment Ceased 01/08 Neuro and Endocrine Tumour and Tissue Bank Dr Diana Benn Senior Research Scientist Cancer Genetics Unit, Kolling Institute of Medical Research, Royal North Shore Hospital St Leonards NSW 2065 09-Apr-2008 Archived - Study Complete 20/07 ACTIVE Dialysis – A Clinical Trial of IntensiVE Dialysis Dr Paul Collett Director of Nephrology Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 12-Dec-2007 Archived - Study Complete 19/07 CoolCath Trial – An international study to assess the safety and efficacy of the CoolMaxTM microwave catheter. Associate Professor Henry Woo Australian Clinical Trials Pty Ltd Australian Clinical Trials Suite 406 San Clinic 185 Fox Valley Road Wahroonga NSW 2076 12-Dec-2007 Archived - Withdrawn 18/07 Bed Head Elevation Study Dr Ian Baldwin 145 Studley Rd Heidelberg VIC 3084 12-Dec-2007 Archived - Withdrawn 17/07 Quantification of NAD+ levels in normal human plasma: correlation with age and oxidative stress. Associate Professor Ross Grant CEO - Australasian Research Institute Chief Scientist Australasian Research Institute 185 Fox Valley Road Wahroonga NSW 2076 12-Dec-2007 Approved 16/07 Does a tea-tree cleansing foam effect the bacterial flora of chronic leg ulcer wounds: a preliminary investigation. Gary Bain Wound Clinic, Sydney Adventist Hospital, 185 Fox Valley Road Wahroonga NSW 2076 12-Dec-2007 Archived - Study Complete 15/07 Development of a semen-based test for prostate cancer. Associate Professor Henry Woo Australian Clinical Trials Pty Ltd Australian Clinical Trials Suite 406 San Clinic 185 Fox Valley Road Wahroonga NSW 2076 12-Dec-2007 Archived - Discontinued 14/07 Automated Pacemaker Home Monitoring Reduces the Need for Regular Routine Clinic Checks Health services innovation grant for the employment of a patient navigator – breast cancer. Dr Jason Sharp 29-Apr-2008 Archived - Study Complete Dr Barbara Newman Patient Navigator, Clinical Services, Sydney Adventist Hospital, 185 Fox Valley Road Wahroonga NSW 2076 31-Oct-2007 Archived - Study Complete 02/08 13/07 Updated 1-Sep-2014 12/07 Portacath Survey Eisen Liang San Radiology 11/07 Breast Cancer Tissue Bank Professor Christine Clarke Westmead Millennium Institute Darcy Road Westmead NSW 2145 05-Sep-2007 Approved 10/07 An inquiry into the development of support groups and their effects on the well-being of people with lung and gynaecological cancer and their carers. Sally Goss Project Coordinator, Lung & Gynaecological Cancer Support, Cancer Support Centre, Sydney Adventist Hospital, 185 Fox Valley Road Wahroonga NSW 2076 10-Aug-2007 Archived - Withdrawn 09/07 International Survey of patients with chronic pain: their experience of pain. Wendy White Clinical Nurse Consultant, Monash University, Wound Foundation of Australia, NSW Branch, PO Box 4665 Lake Haven NSW 2263 09-May-2007 Archived - Study Complete 08/07 Measuring impact on patient nutritional status in the highly dependent patient before and after the implementation of a feeding team*: “a focus on highly dependent patients” Sarah Liston Manager Dietetics, Sydney Adventist Hospital, 185 Fox Valley Road Wahroonga NSW 2076 30-May-2007 Archived - Study Complete 07/07 A 12-month double-blind, randomized, multicenter, active-controlled, parallelgroup study comparing the efficacy and safety of 0.5mg and 1.25mg fingolimod (FTY 720) administered orally once daily versus interferon B1a (Avonex ®)administered i.m. once weekly in patients with relapsingremitting multiple sclerosis. (TRANSFORMS) Proof of concept: an open label pilot study to determine the efficacy and tolerability of a treated gliadincontaining product (GCP) in asymptomatic subjects with coeliac disease. Prof Roy Beran Strategic Health Evaluators, Suite 5, 6th Floor, 12 Thomas Street Chatswood NSW 2067 24-Apr-2007 Archived - Study Complete Associate Professor Ross Grant CEO - Australasian Research Institute Chief Scientist Australasian Research Institute 185 Fox Valley Road Wahroonga NSW 2076 04-Apr-2007 Archived - Study Complete 05/07 An international multi-centre study of tamoxifen vs anastrozole in postmenopausal women with hormone sensitive ductal carcinoma in situ (DCIS) (IBIS II – DCIS). Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 04-Apr-2007 Recruitment Ceased 04/07 The effect of diet and lifestyle on serum adipocytokine levels in adolescent females: implications for insulin resistance and Type 2 diabetes. Associate Professor Ross Grant CEO - Australasian Research Institute Chief Scientist Australasian Research Institute 185 Fox Valley Road Wahroonga NSW 2076 04-Apr-2007 Archived - Study Complete 03/07 Cognitive performance and closed loop stimulation. (COGNITION) 04-Apr-2007 Archived - Study Complete 02/07 A 12-month double-blind, randomized, multicenter, active-controlled, parallelgroup study comparing the efficacy and safety of 0.5mg and 1.25mg fingolimod (FTY 720) administered orally once daily versus interferon B1a (Avonex â)administered i.m. once weekly in patients with relapsingremitting multiple sclerosis. (TRANSFORMS) 07-Feb-2007 Archived - Study Complete 06/07 A/Prof Robert Heard 55 Hills Street Gosford NSW 2250 Archived - Rejected Updated 1-Sep-2014 01/07 New leaves poetry writing project. Ms Carolyn Rickett PO Box 19 Cooranbong NSW 2265 04-Apr-2007 Archived - Study Complete 25/06 A frequent optimization study using the QuickOpt Method. (FREEDOM) Dr Peter Illes 502 San Clinic 185 Fox Valley Road Wahroonga NSW 2076 07-Feb-2007 Archived - Study Complete 24/06 Randomised comparative study of FOLFOX6m plus SIR-spheres versus FOLFOX6m alone as first line treatment in patients with nonresectable liver metastases from primary colorectal carcinoma. (SIRFLOX) Randomised, double-blind, placebocontrolled, parallel-group, doseranging study to investigate the MRI efficacy and the safety of six months administration of firategrast (1501200mg twice daily) in subjects with relapsing-remitting multiple sclerosis. (TIME) Responding to the needs and quality of life experiences of advanced nonsmall cell lung cancer: a focus groups study of patients and carers. Comparison of adipocytokine levels in age, sex and BMI matched vegetarian versus non-vegetarian adults. A phase III randomized, double-blind placebo-controlled, multicentre clinical trial of Rebif new formulation (44mcg tiw and 44 mcg ow) in subjects at high risk of converting to multiple sclerosis (REFLEX). Pilot study for pathways to the diagnosis of thyroid cancer in NSW. Dr Gavin Marx San Clinical Trials Unit Sydney Adventist Hospital 185 Fox Valley Road Wahroonga NSW 2076 04-Oct-2006 Recruitment Ceased 04-Oct-2006 Archived - Withdrawn 18-Dec-2006 Archived - Study Complete 04-Oct-2006 Archived - Study Complete 04-Oct-2006 Archived - Withdrawn 04-Oct-2006 Archived - Study Complete 16-Nov-2006 Archived - Study Complete 04-Oct-2006 Archived - Study Complete 02-Aug-2006 Archived - Study Complete 02-Aug-2006 Archived - Discontinued 07-Jun-2006 Archived - Study Complete 07-Jun-2006 Archived - Discontinued 07-Jun-2006 Archived - Withdrawn 07-Jun-2006 Archived - Discontinued 16-Apr-2006 Archived - Study Complete 05-Apr-2006 Archived - Study Complete 23/06 22/06 21/06 20/06 19/06 18/06 17/06 16/06 15/06 14/06 13/06 12/06 11/06 10/06 09/06 Audit of complication rates and outcomes from radiotherapy treatment of prostate cancer. The effect of reflexology therapy on cancer patients (particularly breast cancer). Investigation of clinical endpoints for treatment-induced gastroesophageal reflux disease (GERD) symptom changes. A randomised single-blind study to improve health-related quality of life as measured by the SF-36 vitality score by correcting anaemia of chronic kidney disease with Aranespâ in the elderly. (STIMULATE) Sensory evaluation and taste threshold data of the minor components of soybeans in soy foods. IBCSG 23-01 A randomised trial of axillary dissection versus no axillary dissection for patients with clinically node negative breast cancer and micrometastases in the sentinel node. (IBCSG 23-01) The effect lipid lowering agents on fat metabolism during aerobic exercise in dyslipidemic individuals A multi-centre randomized trial of sentinel node versus axillary clearance in operable breast cancer.(SNAC2) A long term non-interventional study to evaluate the effectiveness of Aranesp in dialysis patients when administered once every two weeks. (ALTERNATE) Evaluation of variance in the immunogenic activity of hydrolysed selected wheat proteins using isolated human T-cells from celiac sufferers Updated 1-Sep-2014 08/06 07/06 06/06 05/06 04/06 03/06 A retrospective audit of patients undergoing percutaneous closure of patent foramen ovale A randomized, double-blind, placebocontrolled, proof of concept study of Zoledronic acid in spontaneous osteonecrosis of the knee (SONK). (The Zo-SONK study). Progesterone after previous preterm birth for the prevention of neonatal respiratory distress syndrome. (PROGRESS) Prospective comparison of the immunological response following robotic assisted and open retropubic radical prostatectomy for organ confined prostate carcinoma. A study of sharps injuries among SAH staff following adoption of the Sharpsmart Safety Device. A prospective, multicentre clinical trial to evaluate functional outcomes and wear in alumina-Delta bearing surfaces, after primary uncemented total hip replacements. 02/06 Pacing alternate sites using SelectSecure. (PASSES) 01/06 Ethics Committee endorsement as an Authorised Prescriber of an unapproved product under section 19(5) of the Therapeutic Goods Act. Dr William K Walter Specialist Orthopaedic Group, Mater Clinic, Suite 1.08, Level 1, 3-9 Gilles Street North Sydney NSW 2060 Dr David McHarg Practice Manager Practice Manager Northern Nuclear Medicine Suite 306 The San Clinic 07-Jun-2006 Archived - Study Complete 07-Jun-2006 Archived - Discontinued 07-Jun-2006 Archived - Discontinued 05-Apr-2006 Archived - Discontinued 05-Apr-2006 Archived - Study Complete 05-Apr-2006 Archived - Study Complete 05-Apr-2006 Archived - Study Complete 01-Feb-2006 Archived - Study Complete 17-Aug-2005 Archived - Study Complete 06-Apr-2005 Archived - Discontinued 185 Fox Valley Rd Wahroonga NSW 2076 09/05 Vitamin B12 supplementing efficacy of Propionibacterium jensenii 702 08/05 CT0501: Non-comparative, multicentre study to evaluate the safety and efficacy of DePuy Silent Hip prosthesis in primary total hip replacement. 07/05 TVT-O prospective outcomes study 06-Apr-2005 Archived - Study Complete 05/05 Access to Medical Records 02-Feb-2005 Archived - Study Complete 04/05 Sydney – Newcastle Adventist Schools: Teen physical activity and nutrition study Exploring post operative delirium (POD) in the elective, major, colorectal surgical population Anxiety in patients who undergo successful percutaneous coronary intervention (PCI) over time Poster presentation of CT and X-ray case of paediatric osteomyelitis 02-Feb-2005 Archived - Study Complete 02-Feb-2005 Archived - Study Complete 02-Feb-2005 Archived - Study Complete 02-Feb-2005 Archived - Study Complete Association of the Use of Adrenaline in Cardiac Arrest and Outcome, Particularly Stroke – A Case Study National Midwifery Competencies Project 10-Nov-2004 Archived - Study Complete 10-Nov-2004 Archived - Study Complete 17/04 Colonoscopy Research in Symptom Prediction (CRISP) 01-Sep-2004 Archived - Study Complete 16/04 BotuliniumToxin Type A for Urinary Urgency 01-Sep-2004 Archived - Study Complete 15/04 Prospective Safety and efficacy study of the PTQ Implantation Procedure for the treatment of patients diagnosed 01-Sep-2004 Archived - Study Complete 03/05 02/05 01/05 20/04 18/04 Dr James Sullivan SportsMed West, 116 Macquarie Street Parramatta NSW 2150 Updated 1-Sep-2014 with Passive Faecal Incontinence 14/04 A Sentinel Study of Cardiovascular Disease Risk Factors in Australia 01-Sep-2004 Archived - Study Complete 13/04 Developing and Understanding of Family and Social influences on Children’s Physical Activity and Participation in a Community Sporting Event Cancer Caregiver Needs Study. Pilot Study 01-Sep-2004 Archived - Study Complete 01-Sep-2004 Archived - Study Complete 11/04 Authorised Prescriber 01-Sep-2004 Archived - Study Complete 10/04 Stress and Burnout within nursing and midwifery professions 05-May-2004 Archived - Study Complete 09/04 Gluten-Free Wheat Trial. A pilot study. 05-May-2004 Archived - Study Complete 08/04 The Determination of Glycaemic Index of Foods 31-May-2004 Archived - Study Complete 07/04 Equol Production Ability of vegetarians and non-vegetarians to convert daidzein to equol Topical treatments for radiation induced skin responses: a repeated measures, comparative study of a tea tree oil and a paw paw cream dressing Age induced changes in the Human Urinary Bladder 31-May-2004 Archived - Study Complete 05-May-2004 Archived - Study Complete 18-Feb-2004 Archived - Study Complete Retrospective Review of Patients who underwent surgery for Prolapse at SAH Prospective Safety and Efficacy study of Midline Intravaginal Slingplasty for treatment of Urinary Stress Incontinence Neurochemicals and their Receptors in Human Urinary Bladder 18-Feb-2004 Archived - Study Complete 18-Feb-2004 Archived - Discontinued 18-Feb-2004 Archived - Study Complete 18-Feb-2004 Archived - Study Complete 12/04 06/04 05/04 04/04 03/04 02/04 Dr David Harris PO Box 40 COORANBONG NSW 2265 01/04 Trial to Reduce the Incidence of Type 1 diabetes in the Genetically at Risk (TRIGR study) 13/03 Detection of Human Chlamydia pneumoniae infection 12-Nov-2003 Archived - Study Complete 12/03 Stroke patients’ abilities to stand up and to walk after discharge from rehabilitation Study of Heart and Renal Protection (SHARP): a randomised placebo controlled study to assess the effects of cholesterol-lowering therapy with a combination of simvastatin and ezetimibe on the risk of major cardiovascular complications among individuals with renal impairment Mental Fatigue after Walking Exercise 12-Nov-2003 Archived - Study Complete 12-Nov-2003 Archived - Study Complete 03-Sep-2003 Archived - Study Complete Safety and preliminary efficacy study for the MiniaturoTMI system utilized for the treatment of patients diagnosed with interstitial cystitis (IC), overactive bladder (OAB) & urinary urge incontinence (UUI) Volitional Strategies of Self-Regulation 03-Sep-2003 Archived - Study Complete 03-Sep-2003 Archived - Study Complete Observational Study of Common remedies of nausea and vomiting during pregnancy 02-Mar-2003 Archived - Study Complete 11/03 10/03 09/03 08/03 07/03 Dr Neville J Howard Institute of Endocrinology & Diabetes, The Children’s Hospital at Westmead, Locked Bag 4001 Westmead NSW 2145 Updated 1-Sep-2014 06/03 Control of proliferative lifespan in Human Breast Epithelial Cells 05/03 Prayer Power Project 04/03 Characterisation of naturally occurring variations in the cellular genes of children Isolation and Cryopreservation of Cord Blood Stem Cells. Setting up a Stem Cell Unit AuSPEN Nutritional Support Study 19-Mar-2002 Archived - Study Complete 19-Mar-2002 Archived - Study Complete 19-Mar-2002 Archived - Study Complete 01/03 Transition Support Programs for New Graduate Nurses 19-Mar-2002 Archived - Study Complete 15/02 A Sentinel Study of Trends in Coronary Heart Disease Risk Factors in Australia. ARC Linkage Project Transition Support Programs for new Grad Nurses – How effective are they? 11-Nov-2002 Archived - Study Complete 11-Nov-2002 Archived - Study Complete Characterisation of picolinic acid levels and related metabolites in human cerebrospinal fluid and serum Multicentre phase 3 open label study to assess patient preference and sexual encounter attributes of men with switching from sildenafil citrate to tadalafil 20mg. A Phenomenological Study of what is uniquely SDA in Operation of SAH 06-Nov-2002 Archived - Study Complete 06-Nov-2002 Archived - Study Complete 01-Sep-2002 Archived - Study Complete 03-Jul-2002 Archived - Study Complete 03/03 02/03 14/02 13/02 11/02 10/02 07-Jul-2003 Archived - Study Complete Archived - Study Complete 09/02 A pilot study to assess the clinical importance of the Silent Hip 08/02 Does Splinting prevent contracture following stroke 03-Jul-2002 Archived - Study Complete 07/02 The lived experience of coping with renal disease and dialysis treatment 01-May-2002 Archived - Study Complete 06/02 The re-invasion of the medicalised birth: An investigation into the desire for medical intervention during pregnancy and childbirth Approval for use of interventional devices 01-May-2002 Archived - Study Complete 01-May-2002 Archived - Study Complete The incidence and characteristics of pain (stump pain and phantom pain) and phantom sensations in amputees attending prosthetic clinics in Sydney A clinical trial of the efficacy of the topical skin cream 101CSD to resolve superficial basal cell carcinoma A prospective, multicentre, populationbased laboratory surveillance for candidaemia in Australia over a three year period ERCP Audit at Sydney Adventist Hospital 06-Mar-2002 Archived - Study Complete 06-Mar-2002 Archived - Study Complete 06-Mar-2002 Archived - Study Complete 06-Mar-2002 Archived - Study Complete 12/01 Survey of Occupational Health and Safety Services in Hospitals 21-Mar-2001 Archived - Study Complete 11/01 Concerns of caregivers of persons with cancer 21-Mar-2001 Archived - Study Complete 10/01 Australian Breast Cancer Family Study 21-Mar-2001 Archived - Study Complete 09/01 Temperament variables of personality as modifiers of symptoms in stress burnout and burnt out individuals The origins of antibiotic resistance genes in multi-drug resistant clinical isolates Stress and postnatal depression 21-Mar-2001 Archived - Study Complete 21-Mar-2001 Archived - Study Complete 21-Mar-2001 Archived - Study Complete 05/02 04/02 03/02 02/02 01/02 08/01 07/01 Dr James Sullivan SportsMed West, 116 Macquarie Street Parramatta NSW 2150 Updated 1-Sep-2014 06/01 Initiating Dialysis Early and Late (IDEAL) 21-Mar-2001 Archived - Withdrawn 05/01 The use of electromyographic biofeedback as an adjunct to occupational therapy in improving motor control of the upper limb after cerebrovascular accident Not for Resuscitation (NFR) Policy 21-Mar-2001 Archived - Study Complete 21-Mar-2001 Archived - Study Complete Assessment of human prostate pathology by in-vivo magnetic resonance imaging and spectroscopy Socio-economic factors and patterns of care in lung cancer 21-Mar-2001 Archived - Study Complete 21-Mar-2001 Archived - Study Complete The experience of newly registered nurses when faced with ethical situations that challenge their personal values and belief systems 21-Mar-2001 Archived - Study Complete 04/01 03/01 02/01 01/01