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HPV VLP as adjunct therapy for recurrent respiratory papillomatosis.
Expand descriptionThe primary purposes of this study are: 1). To test whether HPV 6 virus like particles given as a vaccine are therapeutic for (ie prevent recurrence after conventional destructive treatment, or prolong the interval to recurrence after conventional destructive treatment) recurrent respiratory papillomatosis. 2). To confirm that this experimental vaccine is safe when used in this way. The vaccine is designed to encourage the body’s defences against infection to attack cells infected by HPV. This study will test different doses of the vaccine to see if they work.
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Does acupuncture improve the endometrium for women undergoing an embryo transfer: a pilot randomised controlled trial
Expand descriptionThe aim of this study is to examine whether the use of acupuncture improves the characteristics of the endometrium associated with implantation and pregnancy. Women will be randomised to receive acupuncture or standard care (control group). Women will be randomised at day 9 subject to the result of ultrasound and blood test. The endometrium will be assessed by vaginal ultrasound and the endometrium thickness and pattern recorded. The ultrasound will be performed by a fertility specialists blind to the study group (routine scan) at day nine to assess timing for egg retrieval. Further ultrasound measurements will be undertaken at the time of Embryo Transfer (ET) and an extra ultrasound undertaken one week following egg retrieval. Routine bloods will be taken prior to egg retrieval and additional blood will be taken on day seven following egg retrieval. Routine measurement of plasma oestradiol and progesterone will be taken. Study group : Treatment with acupuncture Acupuncture points to be used will be selected according to the individual Traditional Chinese Medicine (TCM) diagnosis, and at the time of the first treatment. The second treatment will be administered 25 minutes prior to embryo transfer. Classical acupuncture points pericardium 6 (PC6), Spleen 8 (SP8), Liver 3 (LR3), Stomach 29 (ST29), and Conception vessel (CV4) will be used. Auricular acupuncture points Shenmen, Zhigong, Neifenmi and Naodian will also be used. The third treatment will be administered 25 minutes after embryo transfer using acupuncture points Stomach 36 (ST36), Spleen 6 (SP6), and Spleen 10 (SP10). Auricular points Shenmen, Zhigong, Neifenmi and Naodian will be also be needled. Seirin acupuncture needles will be inserted to tissue level and stimulated manually to elicit the Deqi response. Needles will be retained for 25 minutes in each treatment. Study group 2: Standard care The standard treatment protocols for In Vitro Fertilization (IVF) and embryo transfer will be followed.
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A Phase I, Single Centre, Double Blind, Randomised, Placebo Controlled, Single Escalating Dose Study to Determine the Safety, Tolerability and Absorption of Ha44 Administered Topically to the Hair and Scalp of Healthy Volunteers
Expand descriptionTo study the safety of Ha44 after topical administration. Safety will be assessed by physical examination, including detailed assessment of scalp, face, eyes and ears, vital signs, 12-lead electrocardiogram, laboratory tests including haematology, clinical chemistry and urinalysis and adverse events. Ha44 is a novel insect ovicide.
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ANZ 0301 / BCIRG 103 (1839 IL / 0219) : Presurgical Study Evaluating IRESSA
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Adjuvant Therapy for Postmenopausal Patients with Operable Breast Cancer who have Estrogen Receptor or Progesterone Receptor Positive Tumors. Tamoxifen vs. Letrozole vs. Tamoxifen followed by Letrozole vs. Letrozole followed by Tamoxifen
Expand descriptionTamoxifen is a hormone tablet that improves cure rates in women with early breast cancer. Letrozole is a new hormone tablet that has recently been shown to work in advanced breast cancer. This international trial will determine if in women with early breast cancer, Letrozole is as good or better than tamoxifen, and whether taking both together is better still.
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HERA (HERceptin Adjuvant) Trial
Expand descriptionThe best treatment for some women with early breast cancer includes a few months of chemotherapy after their surgery. However, even with the best treatment, the cancer sometimes re-occurs. Trastuzumab, also known as Herceptin, is a new drug that targets breast cancer cellls that have a special receptor (HER2) on them. Trastuzumab is benefical for women with advanced breast cancers that have HER2. This large, international trial will determine if adding Trastuzumab to best standard treatment improves cure rates for women with early breast cancers with HER2. It will also determine whether it is better to continue treatment with Trastuzumab for 1 or 2 years.
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MOSAIC (Mothers’ Advocates In the Community)
Expand descriptionMOSAIC is a community randomised trial which examines whether mentor mothers can reduce partner abuse and depression, and strengthen health, wellbeing and mother-child bonds in women who are pregnant or have children under 5, attending upskilled and supported Maternal and Child Health (MCH) nurses or GPs. Mentor mothers (MMs) are para-professional trusted community women with additional training in domestic violence and parenting skills, who provide home-visiting, empowerment, advocacy and support to women pregnant or with children under 5, identified as abused or symptomatic of abuse by their GP or nurse. AIMS: The study’s primary aims are: • to reduce partner abuse or depression by 16% among women pregnant or with children under 5 whom GPs or MCH nurses identify as abused or at risk Its secondary aims are: • to strengthen infrastructure support for GP and nurse management of partner abuse, by enhancing effective inter-sectoral collaboration between general practice, MCH nurse teams and community-based family violence networks • to enhance health professional case management of family members living with partner abuse
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The Impact of Inpatient Weight Restoration in Adoelscent Anorexia Nervosa
Expand descriptionSimple Description of the Project This study examines the effect of length of hospital admission for refeeding, prior to manualised outpatient family therapy on outcomes for patients with AN. Subjects will include 72 children and adolescents aged 10 to 18 years admitted for medical management of AN of less than 3 years duration. This study aims to randomly allocate and compare outcomes between individuals with AN admitted for medical stabilisation, approximately 2 to 3 weeks, followed by 20 one hour sessions of outpatient family therapy over a 12 month period versus those admitted for full weight restoration, approximately 9 to 12 weeks also followed by 20 one hour sessions of outpatient family therapy. Physical and psychological outcomes will be measured at admission, at discharge from hospital, completion of outpatient treatment and at 6 and 12 months following outpatient treatment. Interpretation of Results If hospitalisation to a minimum healthy weight produces equivalent outcomes this has the potential to reduce the standard length of current hospital treatment for AN in adolescents from approximately 9 to 12 weeks to 2 to 3 weeks, resulting in benefits including savings of hospital based resources and reductions in the disruptions to schooling, peer and family relationships, adolescent development and family life. Should this not be the case this would support this would support the need for increased periods of hospitalisation with the possible benefits including reduced hospital readmission rates, decreased length of illness, decreased medical complications from malnutrition and lower levels of family and patient distress.
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A Phase I, single dose, open, two-way crossover blood level study of vardenafil blood levels administered as LEVITRA 10mg oral tablets verses a single dose of vardenafil aqueous solution administered to healthy volunteers by inhalation using the IMT nebuliser
Expand descriptionThe study aims to compare the blood levels of vardenafil produced by a single Levitra Tablet vs a nebulised (inhaled) dose of vardenafil.
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The Rabeprazole and Esomeprazole Reflux Assessment Trial
Expand descriptionThe primary purpose of the TREAT study is to compare the number of subjects in which heartburn and regurgitation symptoms resolve after being treated with either PARIET 20mg, NEXIUM 20mg or NEXIUM 40mg. All 3 medications are commonly prescribed for Gastro-oesophageal Reflux Disease (GORD). It is hypothesised that PARIET 20mg will be non-inferior to NEXIUM 40mg in resolving GORD symptoms.