ANZCTR search results

The study is a randomised, double-blind, multi-centre clinical trial to evaluate the use of Chinese herbal medicine in the management of endometriosis. Formulated Chinese herbs will be assessed against an inert placebo. Trial participants will be randomly allocated to either Chinese herbal medicine or placebo. Neither participants nor researchers/assessors will have knowledge of the allocation. It is a prospective clinical study in which participants are reviewed monthly for six months, and three month follow up. Stringent methodology includes an objective laparoscopy diagnosis of endometriosis and suitable outcome measures. The study also includes ensuring participants completing the trial and, facilitating consistent data collection and validity. The trial will be a multi-centre clinical trial with participants recruited and reviewed at several health centres. This will be the first clinical trial in Australia combining Chinese herbal medicine, an objective diagnosis (laparoscopy) and a strict methodological protocol.

Vascular dementia (VaD) is the second most common form of dementia and is a major cause of mental and physical disability in the elderly. There are currently no satisfactory or widely accepted medical options to help alleviate the symptoms associated with this disorder. Traditional Chinese medicine has a well-documented history of using herbal formulations for treatment of dementia-like disorders, but its therapeutic effectiveness has very little or no scientific validation. This controlled clinical trial will investigate the therapeutic effectiveness of a Chinese herbal medicine formula used in the treatment of VaD. 120 patients will be recruited to trial this formula over a four-month period.

Some evidence suggests that Chinese & western herbs may help reduce menopausal symptoms. Therefore, this study will investigate the effectiveness of a herbal formula to alleviate menopausal vasomotor symptoms and improve quality of life. The trial will consist of two arms, an intervention and a placebo group, with random assignment of participants. All participants and trial researchers will be blinded to treatment allocation. Preliminary data will also be gathered on the effect of herbal therapy on bone metabolic markers.

To describe the prevalence of cancerous growths in the small bowel as assessed by capsule endoscopy in a group of patients previously diagnosed with Familial Adenomatous Polyposis (FAP). These patients are known to have previously identified cancerous growths and this study aims to compare the findings of capsule endoscopy to correlate this with the findings by other investigative techniques. These techniques are abdominal Magnetic Resonance Imaging (MRI) scanning, barium follow through examination(SBFT), and gastrointestinal side-viewing endoscopy.

Finger prick blood tests are a widely accepted method of small blood volume collection. Blood collection via finger prick is painful. A reduction in pain and anxiety from finger prick may assist subjects who require numerous procedures. The aim of this study is to assess whether amethocaine reduces the pain and anxiety of finger prick blood sampling

The primary purpose of the study is to determine whether or not acute administration of amphetamine produces schizophrenic-like brain function and cognitive effects.

Lipids form an outer layer of the tear film, which is essential in retarding evaporation of the aqueous layer of the tears. Contact lenses, after being inserted onto the eye, adsorb tear lipids. Analysis of tear lipid changes before and after contact lens wear may reveal which lipid component causes problems (in terms of ocular discomfort and inflammatory responses) with contact lens wear. The study hypothesis is that contact lens wear and/or lens care solutions change the tear lipid profile and thereby influence lens performance.

Bronchiolitis is a common, acute, viral infection of the lower respiratory tract. It is mostly seen in children less than 1 year of age, but does affect children up to 2 years of age. Each year, several children with severe bronchiolitis need admission to the intensive care unit. These children experience significant breathing difficulty and around 50% are ill enough to need help with breathing through a breathing machine called a mechanical ventilator. The normal treatment for these children is to support their breathing, and to give them adequate nutrition and fluids. Aminophylline is a medicine we know from previous research that improves the function of the diaphragm, the major breathing muscle. Aminophylline also stimulates the respiratory centre in the brain, which stimulates the body to breathe. This tells us that aminophylline might be a helpful drug to use when treating children with severe bronchiolitis. Some doctors use this medicine because they believe it works. Others do not use this medicine because they do not believe it works. The purpose of this research project is to see whether aminophylline makes a difference in the treatment of children with bronchiolitis. We will compare a group of children who receive the standard treatment for bronchiolitis with a group of children who receive the standard treatment and aminophylline. We will compare the duration of mechanical ventilation and the length of intensive care and hospital stay in both groups.

The Trident-1 study is an International multi-center, randomized, double-blind, placebo controlled phase 3 clinical trial with plans to randomise a total of 900 patients. The purpose of the study is to determine the effects and safety on the body weight of 3 different doses of BG9928 (0.03 mg/kg, 0.15 mg/kg, or 0.3 mg/kg) and placebo given up to a maximum 5 days to subjects hospitalized due to Acute Decompensated Heart Failure (ADHF) and Renal Insufficiency. BG9928 is a A1 receptor antagonist, which from previous studies have demonstrated ability to preserve renal function and promote urine production. The effect of BG9928 on body weight is thus related to the urine output. The study drug will be given in addition to the medication that would normally be given to ADHF patients. This means that patients on placebo still receive normal standard care. The primary objective of the study is to determine the effect of BG9928, when added to standard therapy, on the change in body weight at 24 hours following the first dose in these subjects. The secondary efficacy objectives of this study are to determine the effect of BG9928, when added to standard therapy, on worsening renal function during the treatment period, the number of days of hospital-free survival (DHFS), the improvement in Dyspnea Symptom and Edema Score, Subject Global Clinical Assessments and Physician Global Clinical Assessment. Additionally the secondary efficacy objectives are measuring the use of concomitant medications to treat heart failure, length of hospital stay, cardiovascular and all-cause mortality and re-hospitalization up to 180 days after the initial dose. The safety objective of the study is to assess the safety and tolerability of BG9928. Upon screening patients will be randomized evenly into either of the 4 treatment arms and will receive IV study drug infusions twice daily for a maximum treatment period of 5 days 910 doses). Prior to and during hospitalisation period, for a maximum of 7 days, the patients will be monitored via physical exam, vital signs, body weight, ECG diagram, questionnaires, blood samples (including pregnancy test for women of childbearing potential, haematology, chemistry, special kidney tests (BNP, Cystatin C), bone markers ,genetic and PK testing. Safety monitoring and concomitant medication monitoring will be conducted from screening and up to day 30 . Telephone follow-up done at 2, 3 and 6 months after the first study dose.

This study will compare the safety and tolerability of a treatment for acromegaly in two groups: one group is injected by a health care professional the other group will inject themselves or have a carer/partner inject.