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A prospective randomised double-blind, double-dummy, placebo-controlled crossover study to determine whether Glucagon-like peptide-1 (GLP-1) stimulates or suppresses pancreatic exocrine function in health.
Expand descriptionOUTCOMES The primary outcome measures are *peak duodenal bicarbonate concentration and pancreatic bicarbonate output (bicarbonate volume times bicarbonate concentration) *peak duodenal amylase concentration and amylase concentration area under the curve (time equals 0 to 60 minutes) Secondary outcome measures are *Plasma concentrations of amylase and lipase
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Evaluation of mesenchymal stem cells in the treatment of knee osteoarthritis – A randomised Controlled Trial
Expand descriptionOsteoarthritis is a major cause of pain and disability world wide. This study aims to explore the effectiveness of autologous mesenchymal stem cell (MSC) injections in treating OA. This study involves the use of autologous MSC, autologous meaning that the cells are taken from and injected back into the same person. Based on previous animal studies and initial human patients, these MSCs are expected reduce pain and assist in bone and cartilage tissue repair, supporting their potential in the treatment of osteoarthritis.
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Intra-articular mesenchymal stem cell injections following arthroscopic microfracture versus arthroscopic microfracture alone for knee cartilage defects: a pilot randomised controlled trial
Expand descriptionThe treatment of isolated knee cartilage defects remains difficult. Research indicates that these isolated lesions lead to later development of generalised osteoarthritis. Traditional and accepted arthroscopic microfracture of these lesions leads to formation of fibrocartilage which unfortunately only causes short to medium term improvement. Use of mesenchymal stem cells injections post micro fracture has shown promise in pre-clinical animal studies and also in initial human trials. We wish to explore the potential of autologous adipose derived mesenchymal stem cell injections post surgery to improve the quality of cartilage repair and prevent later onset development of osteoarthritis.
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A phase Ib/II clinical evaluation of Ponatinib in combination with 5- Azacitidine in patients failing prior therapy for FLT3-ITD positive acute myeloid leukaemia (AMLM21)
Expand descriptionThis study is evaluating Ponatinib in combination with 5-Azacitidine in patients with FLT3- ITD positive acute myeloid leukaemia. Who is it for? You may be eligible to join this study if you are aged over 18 years, have enrolled in the ALLG National Blood Cancer Registry, have FLT3-ITD AML (except Acute Promyelocytic Leukaemia) failing prior chemotherapy or are considered unfit for frontline intensive chemotherapy. You must have adequate liver function (unless due to Gilbert’s syndrome), adequate pancreatic function, and adequate kidney function. The full details of this study's inclusion and exclusion criteria can be found in the relevant sections within this record. Trial details: This study has two parts: Phase Ib involves finding the best dose of Azacitidine to combine with Ponatinib in terms of patient tolerability and safety. The first group of patients enrolled will be treated with 60 mg/m2 of Azacitidine on days 1 -5 & 8 – 9 and 30 mg of Ponatinib on days 5 – 25 of a 28 day cycle. If complete remission of AML is not achieved in the first cycle and no dose reductions for Ponatinib toxicity has occurred Ponatinib should be increased to 45 mg in subsequent cycles. The response to the treatment and adverse events will be assessed by the Trial Management Committee after 6 patients have been evaluated, subsequent patients will be recruited to receive either a higher (75 mg/m2 on days 1 – 5 & 8 – 9 on a 28 day cycle) or lower dose Azacitidine (50 mg/m2 on days 1 – 5 on a 28 day cycle) depending on the response. Both groups would also receive 30 mg of Ponatinib on days 5 – 25 of a 28 day cycle. If complete remission of AML is not achieved in the first cycle and no dose reductions for Ponatinib toxicity has occurred Ponatinib should be increased to 45 mg in subsequent cycles. The response to the treatment and adverse events of both groups will be assessed by the Trial Management Committee to determine a recommended phase II dose. All patients will then receive repeating 28 day cycles of daily oral Ponatinib and Azacitadine injections as long as the therapy continues to fight their leukaemia. Response to the treatment will be assessed at routine clinical visits with the usual clinical investigations that would monitor the status of your disease.
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The effect of selective serotonin reuptake inhibitors (SSRIs) on the circadian light response
Expand descriptionThis study aims to examine the effect Citalopram (a common SSRI medication) has on the body's response to light exposure at night. It is hypothesised that as compared to placebo trials, administration of Citalopram will will result in an altered response to night time light exposure.
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The Effect of Spinal Manipulative Therapy on Non-Specific (Mechanical) Neck Pain
Expand descriptionThe aim of this project is to measure the effect of cervical spinal manipulation on people with non-specific neck pain. The research question relates to whether the magnitude of force of a manipulation influences the extent of effect. The project is a single-blinded randomised controlled clinical trial with three equal groups: one control and two intervention. Sixty-three participants, between the ages of 18 and 35 years with a history of non-specific neck pain originating from the lower cervical spine will be randomly allocated to one of three groups. Group 1 (standard care) will receive a single standardized 5-minute neck stretching exercise routine plus a single manually applied manipulation of the cervical spine. Group 2 (comparison intervention) will receive the same stretching program plus a single instrument applied manipulation to the cervical spine. Group 3 (control) will only receive the stretching program. Outcome measures include changes in neck pain, cervical range of motion, hand grip-strength and blood pressure.
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A Phase 1, Adaptive, Single and Multiple Ascending Dose Study of EMA401 Sodium Salt Administered Orally in Healthy, Adult Males to Determine the Maximum Tolerated Dose and Pharmacokinetic Profiles
Expand descriptionThis integrated, adaptive, single and multiple dose study is designed to determine the maximum tolerated dose as assessed by safety and tolerability and to determine the plasma pharmacokinetics of EMA401 following single and multiple escalating doses, administered orally (up to 2,000 mg/day) in healthy adult male subjects.
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Women's Wellness after Cancer Program
Expand descriptionThe Women's Wellness after Cancer Program (WWACP) will determine the effect of a 12 week, e-health enabled program, on the health-related quality of life (HRQoL) in women who have received treatment for breast, blood, or gynecological cancer. Those who are eligible to join the study are women aged 18 years or above who have completed surgery, chemotherapy, and / or radiotherapy within the past 12 months. Participants in this study are randomly allocated (by chance) to one of two groups. Participants in the intervention group are are given access to an e-health enabled, structured health promotion program which will include an interactive iBook and website containing health information, planning and goal setting, and three personal conferences with a nurse via video-conferencing. Participants in the control group will receive usual care which includes only that information and support that is given as part of usual practice through their usual clinic visits. Participants from both groups will be asked to complete questionnaires before the program begins (0 weeks), at 12 weeks, and again at 24 weeks, in order to determine the effect of the program on HRQoL
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Retrospective/prospective Clinical Study of AcrySof (Registered Trademark) IQ ReSTOR (Registered Trademark) +2.5 D Multifocal Toric Intraocular Lenses, which will collect information about the safety and effectiveness (how the lens works) from participants who have had cataract surgery and been implanted with these intraocular lenses
Expand descriptionThis is a retrospective and prospective clinical study comprised of a retrospective chart review for preoperative, surgical and early postoperative data and a prospective postoperative visit conducted at least 3 months but not more than 14 months after IOL implantation. The study is unmasked with no control group, no randomization and will include approximately 4 sites. The primary objective of the study is to characterize the safety (adverse events) and effectiveness (residual cylinder and visual acuity) of the AcrySof IQ ReSTOR +2.5 D Multifocal Toric IOL in primary eyes of subjects at least 3 months and no more than 14 months after IOL implantation. The primary eye is defined as the eye of a subject that qualifies with the most recent implantation of the study lens (AcrySof IQ ReSTOR +2.5 D Multifocal Toric IOL Models SV25T2-SV25T5)
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Improving ways of thinking and ways of doing (WoTWoD) Aboriginal and Cross Cultural Health in General Practice
Expand descriptionThe majority (60%) of Aboriginal people live in urban Australia. Despite various strategies to “close the gap” in access to care and social services, health inequities and culturally inappropriate care persist. The “Ways of Thinking, Ways of Doing (WoTWoD)” program and toolkit, implemented through partnerships of general practice and Aboriginal Community Controlled Health Services (ACCHs), was developed to guide and effect a whole-of-practice clinical re-design process to embed cultural respect in general practice. Following promising pilot studies, this randomized control trial will test the effectiveness of WoTWoD to improve cultural respect, health checks and cardiovascular risk factors of Aboriginal people in Sydney and Melbourne. The study will be implemented through Medicare Locals in collaboration with local ACCHS. Our hypothesis is that the WoTWoD and care partnerships will improve culturally and clinically appropriate care for Aboriginal people in Australian general practice.