ANZCTR search results

The objective of this study is to evaluate the long-term safety and tolerability of MP03-33, a nasal spray,over a 1-year period in patients with chronic allergic or nonallergic rhinitis. Commercially available azelastine hydrochloride nasal spray will serve as an active control.

The study is being conducted to prove/disprove the hypothesis that Sentinel Lymphadenectomy plus 5 years of serial nodal ultrasound is as effective as Sentinel Lymphadenectomy plus Complete Lymphadenectomy in prolonging disease free survival in patients with metastasis to the sentinel node. This trial is unblinded.

This prospective randomised controlled trial will evaluate the efficacy of providing outpatient physiotherapy rehabilitation to patients via a low-bandwidth Internet-based telerehabilitation system. Possitive outcomes will pave the way for remotely delivered rehabilitation programs via the Internet.

The proposed study represents the second stage in the clinical development of NV-196. The purpose of this study is to deliver the drug over a longer period of time in order (a) to identify a dosage regimen that will deliver a steady state level of drug in the blood, and (b) to characterise the safety profile of the drug.

Falls are common and disabling in people with Parkinson’s disease, affecting up to 60% of those who live at home. This clinical research trial aims to minimize the number of falls and fall-related injuries in people with Parkinson’s disease and to improve mobility and participation in life. Two physical therapy programs, known as “movement strategy training” and “strength training” will be coupled with falls education and compared with a social program plus usual care. The effects of therapy will be measured for a period of 12 months. The data analyst will be blinded to group allocation. After 12 months, quality of life is predicted to be higher in the people that receive strengthening or strategy training because falls and injuries are predicted to be less than for usual care. Quality of life in close family members is also predicted to increase, by lessening the burden of care arising from the disease. The results will provide information about which therapy programs are most effective for reducing falls and improving mobility, so that people with Parkinson’s can continue to lead safe and fulfilling lives.

Each year over 1 million patients globally undergo diagnostic angiography and are discovered to have atherosclerotic plaque amenable to percutaneous coronary intervention (PCI). This area has been extensively researched and benefit shown with the use of aspirin, and more recently 300mg loading dose and 75mg maintenance dose of clopidogrel. Despite the apparent benefit, many patients still do not receive a loading dose (either deliberately – as there is a reasonable probability of being triaged to CABG) or because there is insufficient time (stable patients undergoing diagnostic angiogram who proceed immediately to PCI). Cangrelor is a new drug being developed, which in early phase trials appears to be safe and well tolerated & will provide platelet inhibition throughout the infusion with full recovery of platelet function within 60min of stopping the infusion. This trial aims to demonstrate the efficacy of cangrelor compared to clopidogrel in patients requiring PCI. The primary endpoints to be measured will be all cause mortality, myocardial infarction (MI) and ischemia driven reinfarction (IDR) at 48hrs and 1 month, then mortality at 1year. This study will employ double blind and double dummy tachniques in addition to an active control. Subjects, Investigators, Study Monitor, Data Analyst and the sponsor The Medicines Company will be blinded.

The primary objective is to compare findings achieved by traditional diagnostic procedures with those of the MEDEXTEST in order to define specificity, sensitivity and accuracy of the MEDEXTEST device. Traditional diagnostic procedures include an evaluation by a physician (history and physical examination), Esophagogastroduodenoscopy (EGD) with/without biopsy and Urea Breath Test. The study population will include 200 male and female patients with clinical symptoms of gastroduodenal disorders of similar baseline characteristics (age, BMI and gender). Investigators and Gastroenterologists at Nepean Hospital will refer patients. Eligibility will be determined by satisfying the following inclusion and exclusion criteria. Eligible participants will undergo a baseline evaluation, which includes: written consent, demographic information, medical history, current medications and a physical examination. Participants will undergo the 20-minute MEDEXTEST conducted by a trained Research Assistant. They will be advised of their results at an appointment with their physician following their endodoscopy procedure. The participants will be referred to tests according to clinical and examination findings such as an Esophagogastroduodenoscopy (EGD) (with or without biopsy) and Urea Breath Test. The MEDEXTEST is a non-invasive examination lasting approximately 20 minutes in duration and performed in the following manner: - External measurement of the skin’s electrical resistance of 24 zones located on the participant’s feet and hands. - T.E.N.S stimulation. - A repeated measurement of the 24 zones. - Mathematical processing of the collected information by the help of a previously composed correlative algorithm. - The results will be saved in the operator’s computer memory and, additionally, a printout will be filed in the patient’s source documentation file. At the completion of data collection, a trained physician will make an independent reading from the MEDEXTEST results, with another physician diagnosing the participant based on the traditional procedures. To minimize the risk of bias, all physicians will be blind to their colleague’s diagnosis. A third investigator will compare the diagnosis from the traditional diagnostic procedures against the MEDEXTEST, record test results in participants’ CRF and conduct a follow-up consultation with participant. After the required data is obtained from all study participants of the study site, the results of the MEDEXTEST will be compared with the actual participant’s condition as indicated by the traditional tests, in order to determine the sensitivity, specificity and total accuracy of the device. The estimated duration of the study is 1 year including data analysis and reporting.

This pilot study aims to compare the effect of (1) a nutrition care program and functional strength training with (2) a nutrition care program with conventional exercises in frail older people. Blinded testers will measure performance changes over time.

The objectives of this study are to improve the delivery of venom immunotherapy (VIT) by assessing the efficacy and safety of different approaches to venom immunotherapy, namely ultra-rush (ultra-rapid initiation over 2 days) versus semi-rush (initiation over 10 weeks) and half-dose (50 microgram) versus standard dose (100 microgram) maintenance treatment. Specific hypotheses are that: (i) ultra-rush initiation will be equivalent to outpatient semi-rush initiation in terms of allergic reaction rates to immunotherapy; (ii) A maintenance dose of 50 mcg will be as efficacious as a 100 mcg maintenance dose, and; (iii) VIT with both initiation methods and maintenance doses will have a sustained positive impact (reduced reaction risk) after cessation of VIT. The study will have important implications. If the different approaches are equivalent, we will be able to significantly reduce the amount of venom extract used and thus increase the number of patients that we can treat, given that our venom supplies are expensive and limited. Because it will be impossible to conceal treatment allocations, the different initiation methods will be unblinded. Maintenance doses will be single blinded (known to the treating doctor but not the patient) because of the significant day-to-day dose adjustments required during immunotherapy would make double-blinding difficult and potentially dangerous. The main outcome measures will be (1) the occurence of systemic allergic reactions to immunotherapy (safety of treatment) and (2) systemic allergic reactions to deliberate sting challenges and accidental stings (effectiveness of treatment)