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Keyword: garvan
Recruitment Status: Recruiting
Trial summary
The study is investigating whole body magnetic resonance imaging (MRI) and other diagnostic procedures in people at high risk of cancer. Who is it for? You may be eligible to join this study if you are aged between 18-70 years, and are a known NF1 patient, OR a known cancer risk gene mutation carrier, OR have a family member at 50% risk of carrying a mutation. You will not be eligible if you have an active cancer diagnosis. Study details - All participants in this study will have an initial clinical review followed by annual diagnostic procedures for a period of 3 years. This may include annual whole body MRI scans, breast MRI (females only), fecal occult blood test and full blood count. Additional investigations including colonoscopy and upper gastrointestinal endoscopy may also be conducted at varying time points, as indicated by family history and clinical appropriateness. Participants will also be asked to complete psychosocial questionnaires and invited to participate in in-depth interviews. This study will provide estimates of the prevalence and incidence of investigable lesions, and the acceptability, safety, psychosocial impact, and cost-effectiveness of the screening protocol. This information will be used to design a large scale screening project.
Broad Health ConditionCancer
Specific Health ConditionCancer
Any cancer
Recruitment statusRecruiting
Recruitment Details
Recruitment State
VIC
Hospital
Monash Medical Centre - Clayton campus - Clayton
Hospital
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Hospital
Prince of Wales Hospital - Randwick
Hospital
Peter MacCallum Cancer Centre - Melbourne
Hospital
The Royal Adelaide Hospital - Adelaide
Postcode
3168 - Clayton
Postcode
2010 - Darlinghurst
Postcode
2031 - Randwick
Postcode
3000 - Melbourne
Postcode
5000 - Adelaide
Anticipated date of first participant enrolment9/07/2013
Anticipated date of last participant enrolment1/09/2026
Key inclusion criteria
Known cancer risk gene pathogenic mutation carrier or family member at 50% risk of carrying a mutation ECOG performance status 0 or 1 No active cancer diagnosis. This is defined as the primary tumour having been treated with no clinical or symptomatic evidence of metastatic disease Expected lifespan greater than 3 years
Minimum age18 Years
Maximum age70 Years
GenderBoth males and females
Can Healthy volunteers participate?No
Key exclusion criteria
Inability to provide informed consent Serious co-morbid illness Active cancer diagnosis Inability to undergo study procedures Inability to understand an English language consent form Pregnancy
Sponsor Primary Sponsor Type: Other Collaborative groups
Primary Sponsor Name: Australasian Sarcoma Study Group
Primary Sponsor Address: Peter MacCallum Cancer Centre
305 Grattan Street
Melbourne
Victoria 3000
Primary Sponsor Country: Australia
Trial IDACTRN12613000987763
Contact person for information and recruitmentDr
Mandy Ballinger
The Kinghorn Cancer Centre, Garvan Institute of Medical Research, 370 Victoria Street, Darlinghurst, NSW 2010
+61 2 9355 5806
+61 2 9355 5872m.ballinger@garvan.org.au
Australia
Trial summary
The purpose of this study is to understand how oestrogen controls the use of fat in the liver. The hypothesis is that oestrogen is required to prevent the accumulation of fat in the liver. The mechanism may be direct or mediated by other hormones such as growth hormone, which is regulated by oestrogen. We wish to study the effects of oestrogen compounds called Selective Oestrogen Receptor Modulators (tamoxifen) and a drug that prevents oestrogen production (letrozole) on the secretion of growth hormone from the special gland in brain and how they control the liver production and burning of fat in men and women. We wish to compare these effects with that of natural oestrogen itself in women.
Broad Health ConditionNeuroendocrine regulation of GH secretion by oestrogens
Metabolic effects of oestrogens
Specific Health ConditionMetabolic and Endocrine
Normal metabolism and endocrine development and function
Recruitment statusRecruiting
Anticipated date of first participant enrolment3/08/2010
Key inclusion criteria
Healthy postmenopausal women and men the same age BMI <25 kg/m2
Minimum age50 Years
Maximum age70 Years
GenderBoth males and females
Can Healthy volunteers participate?Yes
Key exclusion criteria
History of liver, kidney diseases, cancer, diabetes, endocrine disorders, that are likely to interfere with the metabolism or excretion of the test medication.
Sponsor Primary Sponsor Type: Other
Primary Sponsor Name: Garvan Institute of Medical Research
Primary Sponsor Address: 384 Victoria St
Darlinghurst 2010 NSW
Primary Sponsor Country: Australia
Trial IDACTRN12611001093976
Contact person for information and recruitment
Vita Birzniece
Garvan Institute of Medical Research
384 Victoria St
Darlinghurst 2010, NSW
+61 2 92958483
+61 2 92958481v.birzniece@garvan.org.au
Australia
Trial summary
Advanced prostate cancer is the second leading cause of cancer death in Australian men. Chemotherapy (Docetaxel) is effective in only 50% of patients with this disease. A molecule, MIC-1, is a potential predictive blood marker and mediator of Docetaxel resistance. This clinical trial will test whether the MIC-1 blood test is a predictor of Docetaxel resistance.
Broad Health ConditionMetastatic castrate-resistant prostate cancer
Specific Health ConditionCancer
Prostate
Recruitment statusRecruiting
Anticipated date of first participant enrolment1/01/2010
Key inclusion criteria
1. Histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiological evidence of metastatic disease. 2. Confirmed castrate-resistant prostate cancer (CRPC) with a minimum of 4 weeks having elapsed between the withdrawal of antiandrogens and enrolment. 3. Patients must have a baseline serum PSA > 10 ng/ml (referred to as PSA #1), and two consecutive rises in serum PSA (referred to as PSA #2 and PSA #3) greater than PSA #1 with each test performed at least one week apart. If PSA #3 is less than PSA #2, the patient remains eligible provided a fourth PSA (PSA #4) is greater than PSA #2. 4. Age > 18 years. 5. Eastern Cooperative Oncology Group Performance status 0-3. 6. A neutrophil count of at least 1500 per cubic millimetre and a platelet count of at least 100 000 per cubic millimetre. 7. Normal bilirubin level and aspartate aminotransferase, alanine aminotransferase and serum creatinine no more than 1.5 times the upper limit of the normal range. 8. Castrate testosterone levels due to either gonadotrophin-releasing hormone (GNRH) agonists or orchidectomy. 9. Informed consent.
Minimum age18 Years
GenderMales
Can Healthy volunteers participate?No
Key exclusion criteria
1. No histological diagnosis of prostate cancer
Sponsor Primary Sponsor Type: Government body
Primary Sponsor Name: Cancer Australia
Primary Sponsor Address: PO Box 1201
Dickson ACT 2602
Primary Sponsor Country: Australia
Trial IDACTRN12611000540910
Contact person for information and recruitment
A./Prof. Lisa Horvath
Sydney Cancer Centre
Missenden Rd
Camperdown
NSW 2050
612 9515 5494
612 9519 1546lisa.horvath@sswahs.nsw.gov.au
Australia
Trial summary
Diabetes is the commonest cause of adult onset blindness. Vision loss, which is irreversible, is a most feared complication of diabetes. A blood fat lowering drug called fenofibrate, available in Australia, has been shown to reduce eye damage in people with Type 2 diabetes by 35-40%, and to prevent eye damage in Type 1 diabetic animal models. This study will evaluate the potential benefits of fenofibrate in 450 adults with Type 1 diabetes who are at high risk of eye damage.
Broad Health ConditionEye disease (retinopathy) in type 1 diabetes mellitus
Diabetic nephropathy in type 1 diabetes mellitus
Specific Health ConditionEye
Diseases / disorders of the eye
Metabolic and Endocrine
Diabetes
Renal and Urogenital
Kidney disease
Recruitment statusRecruiting
Recruitment Details
Recruitment State
ACT,NSW,QLD,SA,WA,VIC
Hospital
Hunter Diabetes Centre - Merewether
Hospital
Royal Prince Alfred Hospital - Camperdown
Hospital
Royal North Shore Hospital - St Leonards
Hospital
Concord Repatriation Hospital - Concord
Hospital
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Hospital
Barwon Health - Geelong Hospital campus - Geelong
Hospital
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Hospital
Baker Heart and Diabetes Institute - Melbourne
Hospital
Princess Alexandra Hospital - Woolloongabba
Hospital
The Royal Adelaide Hospital - Adelaide
Hospital
Fremantle Hospital and Health Service - Fremantle
Hospital
Prince of Wales Hospital - Randwick
Hospital
Royal Melbourne Hospital - City campus - Parkville
Hospital
The Canberra Hospital - Garran
Hospital
Cairns Base Hospital - Cairns
Hospital
Garvan Institute of Medical Research - Darlinghurst
Hospital
Southern Adelaide Diabetes and Endocrine Services - Oaklands Park
Hospital
Mater Adult Hospital - South Brisbane
Hospital
Sunshine Hospital - St Albans
Hospital
South West Retina Liverpool - Liverpool
Postcode
2170 - Liverpool
Postcode
2291 - Merewether
Postcode
2050 - Camperdown
Postcode
2065 - St Leonards
Postcode
2139 - Concord
Postcode
3065 - Fitzroy
Postcode
3220 - Geelong
Postcode
3081 - Heidelberg West
Postcode
3004 - Melbourne
Postcode
4102 - Woolloongabba
Postcode
5000 - Adelaide
Postcode
6160 - Fremantle
Postcode
2031 - Randwick
Postcode
5046 - Oaklands Park
Postcode
3050 - Parkville
Postcode
2605 - Garran
Postcode
4870 - Cairns
Postcode
2170 - Liverpool South
Postcode
2010 - Darlinghurst
Postcode
4101 - South Brisbane
Postcode
3021 - St Albans
Trial location outside Australia
Country
New Zealand
State
Christchurch, Auckland
Country
Hong Kong
State
Shatin, New Territories
Anticipated date of first participant enrolment1/09/2011
Anticipated date of last participant enrolment31/12/2023
Key inclusion criteria
Eligibility criteria for the main study: 1) Men or non-pregnant women (on acceptable contraception) with T1D* according to standard criteria: *T1D defined as either (1) T1D diagnosed below 40 years of age and insulin therapy commencing within one year of T1D diagnosis, or (2) T1D diagnosed before, at or after 40 years of age along with: i) Documented history of ketoacidosis, and/or ii) Documented history of very low or undetectable C-peptide (fasting <200 nmol/L or 0.2 pmol/L), and/or iii) Documented history of T1D related autoantibody/ies (anti-GAD, anti-A2, anti-ZnT8). 2) Age 18 years or over; 3) eGFR must exceed 30 ml/min/1.73m2; 4) Must have at least one eligible eye with non-proliferative retinopathy (ETDRS score 35-53 inclusive) confirmed by current retinal photography within the last 3 months (irrespective of prior laser therapy). Note: Any eye having undergone prior pan-retinal laser therapy is not eligible, but prior focal, macular or grid laser does not exclude that eye from eligibility.; 5) All types of insulin therapy, with no restriction by level of HbA1c; 6) Willing and able to comply with all study requirements, including treatment, assessment and clinic visit attendances; 7) Able to personally read and understand the Participant Information and Consent Form and provide written, signed and dated informed consent to participate in the study. Eligibility criteria for the reference group is limited to age and gender matched individuals who do not have T1D.
Minimum age18 Years
GenderBoth males and females
Can Healthy volunteers participate?Yes
Key exclusion criteria
1) Definite indication for or contraindications to fibrate treatment (Other lipid drugs [e.g. statins, ezetimibe, fish oils] are allowed.); 2) Need for bilateral intra-ocular treatment or laser photocoagulation therapy within the next 3 months (this exclusion only applies to retinal laser photocoagulation treatment to the posterior pole i.e. laser correction of corneas for short-sightedness is NOT an exclusion criterion); 3) Prior bilateral pan-retinal photocoagulation (PRP) treatment for diabetic retinopathy; 4) Prior bilateral intra-ocular injection(s) within the last 6 months; 5) Bilateral cataract surgery within the last 6 months; 6) Planned bilateral cataract surgery within the next 12 months; 7) History of any other non-diabetic eye disease that is or is likely to affect bilateral vision; 8) History of photosensitive skin rash or myositis; 9) Abnormal thyroid function (untreated); 10) Liver function tests exceeding 3xULN; 11) Persistent elevated unexplained blood CPK level above normal range; 12) Documented fasting TG levels >6.5 mmol/L; 13) History of pancreatitis, DVT or pulmonary embolism; 14) Use of investigational drugs in the prior 8 weeks; 15) Any unstable condition in last 3 months including active sepsis, diabetic ketoacidosis; 16) MI, unstable angina, stroke or heart failure within last 6 months; 17) Diagnosed cancer with ongoing treatment or prognosis anticipated at <5 years; 18) Any obstacle to regular follow-up including scheduled clinic attendances; 19) Prior or planned organ transplantation (including islet cells) with subsequent continued immunosuppression therapy.
Sponsor Primary Sponsor Type: University
Primary Sponsor Name: NHMRC Clinical Trials Centre, University of Sydney
Primary Sponsor Address: Medical Foundation Building
92-94 Parramatta Road, Camperdown NSW 2050
Primary Sponsor Country: Australia
Trial websitehttps://ctc.usyd.edu.au/our-work/research-divisions/diabetes/current-research/fame-1-eye-trial/
Trial IDACTRN12611000249954
Contact person for information and recruitmentMrs
Liping Li
Medical Foundation Building
92-94 Parramatta Road
Camperdown NSW 2050
+61 2 9562 5000fame1eye.study@sydney.edu.au
Australia
Trial summary
Vitamin D deficiency is common amongst people with type 2 diabetes. People with type 2 diabetes frequently develop painful neuropathy ("nerve pain" especially in the feet). The study hypothesis is that vitamin D supplementation may improve symptoms of nerve pain. The study is therefore designed to investigate the impact of vitamin D supplementation on nerve pain in people with type 2 diabetes
Broad Health ConditionNeuropathic pain in type 2 diabetes
Specific Health ConditionMetabolic and Endocrine
Diabetes
Neurological
Other neurological disorders
Recruitment statusRecruiting
Anticipated date of first participant enrolment1/04/2010
Key inclusion criteria
Patients with type 2 diabetes and with painful neuropathy with a serum 25-hydroxyvitamin D level of less than 50 nmol/L
Minimum age40 Years
Maximum age80 Years
GenderBoth males and females
Can Healthy volunteers participate?No
Key exclusion criteria
Patients with type 1 or secondary diabetes, hypercalcaemia or renal stone
Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: St Vincent's Hospital
Primary Sponsor Address: 390 Victoria Street, Darlinghurst
NSW 2010
Primary Sponsor Country: Australia
Trial IDACTRN12610000322033
Contact person for information and recruitment
Paul Lee
Department of Endocrinology
Garvan Institute of Medical Research
384 Victoria Street
Darlinghurst
New South Wales 2010
+61 2 9295 8486
+61 2 9295 8481p.lee@garvan.org.au
Australia
Trial summary
The study objective is to investigate the metabolic effects of beta2-agonist in humans, including whole body energy expenditure, fat oxidation, protein synthesis and turnover
Broad Health ConditionObesity
Specific Health ConditionMetabolic and Endocrine
Normal metabolism and endocrine development and function
Recruitment statusRecruiting
Anticipated date of first participant enrolment1/08/2009
Key inclusion criteria
Healthy adults
Minimum age20 Years
Maximum age40 Years
GenderBoth males and females
Can Healthy volunteers participate?Yes
Key exclusion criteria
Any active medical conditions necessitating medication
Sponsor Primary Sponsor Type: Government body
Primary Sponsor Name: National Health and Medical Research Council
Primary Sponsor Address: National Health and Medical Research Council
National Institute of Clinical Studies
GPO Box 4530
Melbourne Vic 3001
Primary Sponsor Country: Australia
Trial websiteNone
Trial IDACTRN12610000161022
Contact person for information and recruitment
Paul Lee
Garvan Institute of Medical Research
384 Victoria Street
Darlinghurst
New South Wales 2010
+61 2 9295 8486
+61 2 9295 8481p.lee@garvan.org.au
Australia
Trial summary
This study aims to identify inherited risk in individuals with sarcoma to aid in the creation of a research resource consisting of biospecimens and associated data. Who is it for? You may be eligible to join this study if you have been diagnosed with sarcoma. Study details Participants will be identified at key sarcoma clinics, asked to complete a questionnarie and provide biospecimens (blood and tissue). The biospecimens will be stored indefinitely in a tissue bank to be utilised by researchers investigating genetic factors contributing to cancer. Information obtained from the questionnaire will be used to ascertain the family history of cancer and other factors that may contribute to development of the disease. The ongoing nature of the project will enable continual provision of important practical information for clinicians and patients leading to more favourable outcomes. Sarcomas contribute disproportionately to cancer burden in our community, because they affect the young, treatment is costly and prolonged and morbidity and mortality is high. Genetic factors appear important in sarcomas, although they have not been well studied for the adult population. Early detection by identifying those at risk may lead to better prognoses. This project aims to create a vital research resource to enable further study into the genetic factors contributing to the hereditary risk of developing sarcoma.
Broad Health Conditionsarcoma
genetic mutations
Specific Health ConditionCancer
Sarcoma (also see 'Bone') - soft tissue
Human Genetics and Inherited Disorders
Other human genetics and inherited disorders
Recruitment statusRecruiting
Recruitment Details
Recruitment State
NSW,QLD,SA,WA,VIC
Trial location outside Australia
Country
United Kingdom
State
London
Country
India
State
Mumbai
Country
France
State
Lyon
Country
United States of America
State
Utah
Country
Korea, Republic Of
State
Seoul
Country
New Zealand
State
Canterbury
Anticipated date of first participant enrolment1/07/2009
Key inclusion criteria
All those diagnosed with sarcoma are eligible for inclusion. Controls must be age matched within 5 years of the proband, be older than or equal to 18 years of age, not have had a cancer diagnosis and not be a blood relative.
GenderBoth males and females
Can Healthy volunteers participate?No
Key exclusion criteria
Controls must be older than or equal to 18 years of age
Sponsor Primary Sponsor Type: Other Collaborative groups
Primary Sponsor Name: Australasian Sarcoma Study Group
Primary Sponsor Address: Peter MacCallum Cancer Centre
305 Grattan Street
Melbourne
Victoria 3000
Primary Sponsor Country: Australia
Trial websitewww.australiansarcomagroup.org/sarcomakindredstudy/
Trial IDACTRN12610000120077
UTNU1111-1113-4959
Contact person for information and recruitmentDr
Mandy Ballinger
The Kinghorn Cancer Centre, Garvan Institute of Medical Research, 370 Victoria Street, Darlinghurst, NSW 2010
+61 2 9355 5806
+61 2 9355 5872m.ballinger@garvan.org.au
Australia
Trial summary
We aim to investigate the effects of raloxifene (SERM) in hypogonadal men on the growth hormone system and metabolism.
Broad Health ConditionMetabolic effects in men with low testosterone
Specific Health ConditionMetabolic and Endocrine
Normal metabolism and endocrine development and function
Recruitment statusRecruiting
Anticipated date of first participant enrolment6/02/2008
Key inclusion criteria
Hypogonadism (prostate cancer patients on androgen deprivation therapy for at least 6 months)
Minimum age40 Years
Maximum age80 Years
GenderMales
Can Healthy volunteers participate?No
Key exclusion criteria
Androgen deprivation for less than 6 months, metastasis, cancer in other tissues than prostate, diabetes, kidney and liver disease, deep vein thrombosis
Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Department of Endocrinology, St Vincent's Hospital
Primary Sponsor Address: 390 Victoria St Darlinghurst, NSW 2010
Primary Sponsor Country: Australia
Trial IDACTRN12608000537358
Contact person for information and recruitment
Prof Ken Ho, MD, FRACP, Head of Dept of Endocrinology, St Vincent’s Hospital
Pituitary Research Unit
Garvan Institute of Medical Research
384 Victoria Street
Darlinghurst
2010 NSW
02 9295 8482
02 9295 8481k.ho@garvan.org.au
Australia
Trial summary
We aim to investigate and compare the effects of raloxifene and tamoxifen (two most commonly used SERMs) in healthy men and women on the growth hormone system and metabolism.
Broad Health ConditionMetabolic effects in healthy men and healthy postmenopausal women
Specific Health ConditionMetabolic and Endocrine
Normal metabolism and endocrine development and function
Trial FocusEducational / counselling / training
Recruitment statusRecruiting
Anticipated date of first participant enrolment27/11/2006
Key inclusion criteria
Healthy postmenopausal women and healthy men the same age
Minimum age50 Years
Maximum age80 Years
GenderBoth males and females
Can Healthy volunteers participate?Yes
Key exclusion criteria
obesity, diabetes, cancer, kidney or liver diseases, deep vein thrombosis
Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Department of Endocrinology, St Vincent's Hospital
Primary Sponsor Address: 390 Victoria St Darlinghurst, NSW 2010
Primary Sponsor Country: Australia
Trial IDACTRN12607000586415
Contact person for information and recruitment
Prof Ken Ho, MD, FRACP, Head of Dept of Endocrinology, St Vincent’s Hospital
Pituitary Research Unit
Garvan Institute of Medical Research
384 Victoria Street
Darlinghurst
2010 NSW
02 9295 8482
02 9295 8481k.ho@garvan.org.au
Australia
Trial summary
The purpose of this study is to find out if a new genetic test (GSTP1 methylation) is a better way of assessing patients’ response to chemotherapy compared to the standard methods (eg PSA blood test). In addition, this study will attempt to find new ways of predicting patient’s response to chemotherapy before they start treatment.
Broad Health ConditionPatients with Metastatic hormone-refractory prostate cancer
Specific Health ConditionCancer
Prostate
Recruitment statusRecruiting
Anticipated date of first participant enrolment1/07/2006
Key inclusion criteria
1. Histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiological evidence of metastatic disease.2. Confirmed Hormone-refractory prostate cancer (HRPC) with a minimum of 4 weeks having elapsed between the withdrawal of antiandrogens and enrolment.3. Patients must have a baseline serum Prostate-specific antigen (PSA)> 10 ng/ml (referred to as PSA #1), and two consecutive rises in serum PSA (referred to as PSA #2 and PSA #3) greater than PSA #1 with each test performed at least one week apart. If PSA #3 is less than PSA #2, the patient remains eligible provided a fourth PSA (PSA #4) is greater than PSA #2.4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-3.5. A neutrophil count of at least 1500 per cubic millimetre and a platelet count of at least 100 000 per cubic millimetre.6. Normal bilirubin level and AST, ALT and serum creatinine no more than 1.5 times the upper limit of the normal range. 7. Castrate testosterone levels due to either luteinizing hormone-releasing hormone (LHRH) agonists or orchidectomy.8. Informed consent.
Minimum age18 Years
GenderMales
Can Healthy volunteers participate?No
Key exclusion criteria
1. Patients taking alternative therapies (eg Saw Palmetto, dehydroepiandrosterone (DHEA), lycopene, PC-SPES, vitamin D, selenium).2. Patients receiving chemotherapy other than Docetaxel or Mitoxantrone (eg cyclophosphamide).
Sponsor Primary Sponsor Type: Individual
Primary Sponsor Name: Dr Lisa Horvath
Primary Sponsor Address: Sydney Cancer Centre
Royal Prince Alfred Hospital
Missended Rd
CAMPERDOWN NSW 2050
Primary Sponsor Country: Australia
Trial IDACTRN12607000077460
Contact person for information and recruitment
Mr Quoc Nguyen
PRIMe
The Garvan Institute of Medical Research
384 Victoria St
DARLINGHURST NSW 2010
+61 2 92958349
+61 2 9295 84223q.nguyen@garvan.org.au
Australia
Trial summary
A prospective, non-randomised, 48 week study of the effect of PI containing and non-PI containing antiretroviral regimens on the expression of adipocyte specific genes, protein levels and cellular structure in HIV-infected individuals, naive to therapy, who are starting therapy for the first time.
Broad Health ConditionHIV
Metabolic abnormality
Lipodystrophy
Cardiovascular disease
Specific Health ConditionInfection
Acquired immune deficiency syndrome (AIDS / HIV)
Cardiovascular
Other cardiovascular diseases
Recruitment statusRecruiting
Anticipated date of first participant enrolment3/02/2004
Key inclusion criteria
Be able to provide written consent to perform in the trial.- HIV antibody positive at time of entry to the study.Specific to HAMA part A only:- Be naive to antiretroviral medication.Specific to HAMA part B only:- Have had a minimum total exposure to antiretroviral medications (to include drugs from more than one drug class) of 48 weeks at time of recruitment.- Have had a minimum of 48 weeks interval since completion of HAMA part A.
Minimum age18 Years
GenderBoth males and females
Can Healthy volunteers participate?No
Key exclusion criteria
General:- Any history of, or ongoing, mental or physical condition (including suspected or known diagnosis of ischaemic heart disease), which, in the opinion of the investigator, would impede the subjects ability to participate in the trial.- Prior use of growth hormone or glucocorticoid or anabolic steroid products within the previous six months.- Prior use of supraphysiological doses of testosterone or oestrogen replacement therapy within the previous year.- Alcohol or substance abuse which in the opinion of the investigator would affect the patients ability to participate in the trial.- Prior use of any retinoid-containing compound within the previous six months.- Abnormal coagulation.- Previous allergic reaction or known allergy to local anaesthetic.- Previous or concomitant use of medications, which, in the opinion of the investigator, would affect the subjects ability to participate in all activities involved in the trial.- Any grade-three laboratory abnormality recorded from screening bloods, which, in the opinion of the investigator, would impede the subjects ability to safely complete all study requirements.- Any finding on screening clinical examination, which, in the opinion of the investigator, would impede the subjects ability to participate in the rest of the trial.- PregnancySpecific to HAMA part A only:- Prior use of anti-retroviral agents (including protease inhibitors, nucleoside or non-nucleoside reverse transcriptase inhibitors, investigational antiretroviral agents or fusion inhibitors). Entry of individuals who have had previous antiretroviral therapy as part of Post Exposure Prophylaxis will be at the discretion of the study investigators.
Sponsor Primary Sponsor Type: University
Primary Sponsor Name: The University of New South Wales
Primary Sponsor Country: Australia
Trial IDACTRN12605000662662
Contact person for information and recruitment
Patrick WG Mallon
The National Centre in HIV Epidemiology and Clinical Research
Level 2
376 Victoria Street
Darlinghurst NSW 2010
+61 2 83823107pmallon@nchecr.unsw.edu.au
Australia
Trial summary
A randomised study of the effect of treatment with Combivir (zidovudine [AZT] and lamivudine [3TC]) and Kaletra (lopinavir [LPVr]), alone and in combination, on the development of abnormalities in lipid and glucose metabolism in HIV negative healthy subjects
Broad Health ConditionHIV
Lipid metabolism
Glucose metabolism
Metabolic abnormality
Lipodystrophy
Cardiovascular disease
Specific Health ConditionInfection
Acquired immune deficiency syndrome (AIDS / HIV)
Cardiovascular
Other cardiovascular diseases
Recruitment statusRecruiting
Anticipated date of first participant enrolment1/11/2004
Key inclusion criteria
Be able to provide written consent to perform in the trial. - HIV antibody negative and HIV DNA negative at time of entry to the study.
Minimum age18 Years
GenderBoth males and females
Can Healthy volunteers participate?No
Key exclusion criteria
Any history of, or ongoing, mental or physical condition (including suspected or known diagnosis of ischaemic heart disease), which, in the opinion of the investigator, would impede the subjects ability to participate in the trial.- History of type I or type II diabetes mellitus or previous treatment with antidiabetic medication. - Prior use of testosterone, oestrogen, growth hormone or other oral glucocorticoid or anabolic steroid products within the previous six months. - Alcohol or substance abuse which in the opinion of the investigator would affect the subjects ability to participate in the trial. - Prior use of anti-retroviral agents (including protease inhibitors, nucleoside or non-nucleoside reverse transcriptase inhibitors, investigational antiretroviral agents or fusion inhibitors either in a previous study, as treatment or as part of post-exposure prophylaxis).- Prior use of any retinoid-containing compound within the previous six months. - Abnormal coagulation. - Previous allergic reaction or known allergy to local anaesthetic. - Previous use of psychotropic medications. - Concomitant use of medications, including those metabolised by CYP3A4 enzyme system (appendix C), which, in the opinion of the investigator, would affect the subjects ability to participate in all activities involved in the trial. - Any grade-three laboratory abnormality recorded from screening bloods. - Any grade-two laboratory abnormality recorded from screening bloods, which, in the opinion of the investigator, would impede the subjects ability to safely complete all study requirements. - Gastrointestinal disorders, which may affect drug absorption. - Any finding on screening clinical examination, which, in the opinion of the investigator, would impede the subjects ability to participate in the rest of the trial.- Pregnancy - Evidence of acute or chronic active hepatitis B virus infection by serology performed at baseline. - Evidence of hepatitis C infection by serology performed at baseline.
Sponsor Primary Sponsor Type: University
Primary Sponsor Name: The University of New South Wales
Primary Sponsor Country: Australia
Trial IDACTRN12605000661673
Contact person for information and recruitment
Patrick WG Mallon
The National Centre in HIV Epidemiology and Clinical Research
Level 2
376 Victoria Street
Darlinghurst NSW 2010
+61 2 83823107pmallon@nchecr.unsw.edu.au
Australia
Trial summary
The primary purpose is to determine whether growth hormone and androgens alter protein metabolism in a way that will reduce protein loss in long-term glucocorticoid users. If so they may be a potential therapy to reduce the skin thinning and muscle weakness that occurs during longterm glucocorticoid use.
Broad Health ConditionLong-term glucocorticoid users with polymyalgia rheumatica
Inflammatory arthritis
Specific Health ConditionInflammatory and Immune System
Rheumatoid arthritis
Recruitment statusRecruiting
Anticipated date of first participant enrolment1/07/2004
Key inclusion criteria
Receiving prednisone for > 6 months for polymyalgia rheumatica or inflammatory arthritis.
GenderBoth males and females
Can Healthy volunteers participate?No
Key exclusion criteria
Diabetes mellitus, cancer, liver or kidney failure.
Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: St Vincent's Hospital
Primary Sponsor Country: Australia
Trial IDACTRN12605000642684
Contact person for information and recruitment
Professor Ken Ho
Pituitary Research Unit
Garvan Institute of Medical Research
384 Victoria St
Darlinghurst NSW 2010
+61 2 92958482
+61 2 92958481k.ho@garvan.org.au
Australia
Trial summary
Observations from previous studies suggest that the full action of GH requires the presence of male hormones like Testosterone (T). We will test the hypothesis that T enhances GH effect acting on the liver. We will compare the body protein production after delivering T exclusively to the liver (capsules) and to peripheral tissues (patch). The first phase (11 weeks, 6 visits) aims to find the T dose which exposes the liver to normal/physiological T levels. The second phase (16 weeks, 5 visits) will compare the effect of delivering T to the liver and to peripheral tissues.
Broad Health ConditionMen with hypogonadism
Men with hypopituitarism
Specific Health ConditionMetabolic and Endocrine
Diabetes
Recruitment statusRecruiting
Anticipated date of first participant enrolment1/06/2005
Key inclusion criteria
Hypogonadism or hypopituitarism (baseline T < 2 nmol/L)
GenderMales
Can Healthy volunteers participate?No
Key exclusion criteria
No exclusion criteria
Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Department of Endocrinology, St Vincents Hospital Sydney
Primary Sponsor Country: Australia
Trial IDACTRN12605000482662
Contact person for information and recruitment
Dr Ken Ho
Professor of Medicine
Head
Pituitary Research Unit
Garvan Institute Chairman
Department of Endocrinology
Garvan Institute of Medical Research
St Vincent's Hospital
384 Victoria Street
Darlinghurst NSW 2010
+61 2 92958203
+61 2 92958411k.ho@garvan.unsw.edu.au
Australia
Trial summary
Acromegaly, GH deficiency and Cushing's syndrome all alter body protein. The aim was to compare protein metabolism in these 3 conditions to normal subjects, along with how protein metabolism changes following surgical removal of hormone-secreting tumour.
Broad Health ConditionNormal subjects
GH deficiency
Acromegaly
Cushing's syndrome
Specific Health ConditionMetabolic and Endocrine
Other metabolic and endocrine disorders
Recruitment statusRecruiting
Anticipated date of first participant enrolment1/01/1995
Key inclusion criteria
Subjects with GH deficiency, acromegaly and Cushing's syndrome and normal volunteers.
GenderBoth males and females
Can Healthy volunteers participate?No
Key exclusion criteria
Cancer, hepatic and renal failure.
Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: St Vincent's Hospital
Primary Sponsor Country: Australia
Trial IDACTRN12605000445673
Contact person for information and recruitment
Professor Ken Ho
Pituitary Research Unit
Garvan Institute of Medical Research
384 Victoria St
Darlinghurst NSW 2010
+61 2 92958482
+61 2 92958481k.ho@garvan.org.au
Australia
Trial summary
The aim of this study is to determine if short-term low dose glucocorticoids alters protein metabolism in a way that results in protein loss. This information will help in the development of therapies that reverse or prevent protein loss in patients requiring long-term glucocorticoids.
Broad Health ConditionHealthy volunteers
Specific Health ConditionMetabolic and Endocrine
Normal metabolism and endocrine development and function
Recruitment statusRecruiting
Anticipated date of first participant enrolment3/01/2005
Key inclusion criteria
Healthy subjects.
Minimum age50 Years
Maximum age80 Years
GenderBoth males and females
Can Healthy volunteers participate?No
Key exclusion criteria
Diabetes mellitus, cancer, liver and kidney failure.
Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: St Vincent's Hospital
Primary Sponsor Country: Australia
Trial IDACTRN12605000443695
Contact person for information and recruitment
Professor Ken Ho
Pituitary Research Unit
Garvan Institute of Medical Research
384 Victoria St
Darlinghurst NSW 2010
+61 2 92958482
+61 2 92958481k.ho@garvan.org.au
Australia
Trial summary
A randomised control study of metformin in people with mild cognitive impairment and without diabetes mellitus to determine effects on cognitive decline and neuroimaging over 3 years.
Broad Health Conditioncognitive decline
dementia
cerebrovascular disease
insulin resistance
neurodegeneration
inflammation
diabetes
Specific Health ConditionCognitive Decline
Recruitment statusRecruiting
Recruitment Details
Recruitment State
NSW,
Key inclusion criteria
Inclusion Criteria: - overweight or obese (body mass index >25.0 kg/m2, waist: women>80 cm, men>94cm; - Mild cognitive impairment (Mild Neurocognitive Disorder), based on DSM-5 criteria; - Fasting blood glucose <7.0 mmol/L and HbA1c <6.5%; - Able to undertake neurocognitive testing in English. - Not participating in another trial of drugs or lifestyle modification to reduce cognitive decline. Exclusion Criteria: - Life-threatening illnesses to preclude participation in a 3-year study; - Contraindications to the use of metformin (severe heart failure or eGFR <40).
Minimum age60 Years
Maximum age80 Years
GenderAll
Can Healthy volunteers participate?Accepts Healthy Volunteers
Sponsor Primary Sponsor Type: Other
Primary Sponsor Name: Garvan Institute of Medical Research
Trial websitehttps://clinicaltrials.gov/show/NCT04511416
Trial IDNCT04511416
Trial summary
Prediabetes is a common condition in overweight individuals affecting approximately 35% of American adults and 30% of Australian adults. Like diabetes, prediabetes is a serious risk factor for cardiovascular disease, eye, kidney and liver disease, and some types of cancer. Appropriate blood glucose control is crucial in preventing pre-diabetes complications and onset of diabetes, yet clinical practice, backed by randomised trials, reports that many patients treated with standard dietary guidelines or with the first-line treatment of diabetes patients, metformin, do not improve blood glucose control sufficiently. The overarching goal of the present project is to improve the efficacy of metformin mono-therapy in pre-diabetes and early type 2 diabetes.
Broad Health ConditionPre Diabetes
Insulin resistance
Metformin
Gut microbiota
Type 2 Diabetes Mellitus
Specific Health ConditionPre Diabetes
Type 2 Diabetes Mellitus
Recruitment statusRecruiting
Recruitment Details
Recruitment State
NSW,
Key inclusion criteria
Inclusion criteria: - Individuals with pre-diabetes or newly-diagnosed (in the last 6 months) with type 2 diabetes, fulfilling the following criteria: - Impaired fasting glucose (IFG, plasma glucose [PG]- 5.6 - 6.9 mmol/L, ±0.2 mmol/L) and/or impaired glucose tolerance (IGT, 2-h PG 7.8 - 11.0 mmol/L, ±0.2 mmol/L) with or without elevated HbA1c (up to 8.0 %). - Willingness to provide written informed consent and willingness to participate and comply with the study. Exclusion Criteria: - Females planning a pregnancy during the course of the research or 3 months after completion of the research project. - Patients with type 1 diabetes, chronically active inflammatory disease, neoplastic disease in the previous 3 years, chronic gastrointestinal disorders, including inflammatory bowel disease or celiac. - Liver enzymes ALT and/or AST>3-times normal range limit. - Abnormal renal function as measured by (eGFR<45 mL/min/1.73m^2). - Individuals with a history of a psychological illness or condition that may interfere with the individual's ability to understand the requirements of the study. - Normo-glycaemia. - HbA1c>8.0% - Cardiovascular event in the previous 6 months. - Current or recent (within 24 months) treatment with a glucose lowering medication (i.e. GLP-1 receptor agonist, SGLT2 inhibitor, thiazolidinedione, sulfonylurea, DPP-4 inhibitor or insulin). - Current or recent (within 3 months) treatment with metformin. - Treatment with an oral steroid. - Treatment with antibiotics/antifungal in the last 3 month. - Treatment with immunosuppressive medications. - Alcohol or substance abuse. - Participants who had received an investigational new drug within the last 6 months. - Participants involved in another clinical study. - Participants who actively lose weight. - Participants who had a bariatric surgery.
Minimum age20 Years
Maximum age70 Years
GenderAll
Sponsor Primary Sponsor Type: Other
Primary Sponsor Name: Garvan Institute of Medical Research
Trial websitehttps://clinicaltrials.gov/show/NCT03558867
Trial IDNCT03558867
Trial summary
This is a multicentre prospective study of the feasibility and clinical value of a diagnostic service for identifying therapeutic targets and recommending personalised treatment for children and adolescents with high-risk cancer.
Broad Health Conditionchildren
precision medicine
personalised medicine
high-risk cancer
refractory
recurrent
sequencing
patient derived xenograft
molecular profiling
paediatric
Specific Health ConditionChildhood Cancer
Childhood Solid Tumor
Childhood Brain Tumor
Childhood Leukemia
Refractory Cancer
Relapsed Cancer
Recruitment statusRecruiting
Recruitment Details
Recruitment State
NSW,QLD,SA,VIC,WA,
Hospital
John Hunter Children's Hospital
Hospital
Sydney Children's Hospital, Randwick
Hospital
The Children's Hospital at Westmead
Hospital
Queensland Children's Hospital
Hospital
Women's and Children's Hospital
Hospital
Royal Children's Hospital
Hospital
Monash Children's Hospital
Hospital
Perth Children's Hospital
Key inclusion criteria
Inclusion criteria (all must be met) 1. Age = 21 years 2. Histologic diagnosis of high-risk malignancy defined as expected overall survival < 30% OR where standard therapy would result in unacceptable and severe morbidity 3. Appropriate tissue samples are available for analysis 4. Life expectancy > 6 weeks 5. Written informed consent
Maximum age21 Years
GenderAll
Sponsor Primary Sponsor Type: Other
Primary Sponsor Name: Sydney Children's Hospitals Network
Trial websitehttps://clinicaltrials.gov/show/NCT03336931
Trial IDNCT03336931