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NCT ID: NCT01104571 Active, not recruiting - Breast Cancer Clinical Trials

Trastuzumab or Lapatinib Ditosylate in Treating Women With Early Breast Cancer

EPHOS-B
Start date: April 2010
Phase: Phase 3
Study type: Interventional

RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether trastuzumab or lapatinib ditosylate is more effective in treating women with early breast cancer. Update June 2013: Since the initial development of EPHOS-B in 2007 more evidence in relation to safety and efficacy of anti-HER2 therapies are now available, and in particular, a growing body of evidence that combinations of two anti-HER2 therapies are more effective than monotherapies. Therefore this study has been amended (PART 2) to a 1:1:2 ratio to control, perioperative trastuzumab or the combination of lapatinib and trastuzumab. PURPOSE: This randomized phase III trial is studying trastuzumab to see how well it works compared with lapatinib ditosylate (and in since June 2013 - compared with a combination of lapatinib and trastuzumab) in treating women with early breast cancer.

NCT ID: NCT01101425 Active, not recruiting - Breast Cancer Clinical Trials

Male Breast Cancer: Understanding the Biology for Improved Patient Care

Start date: December 2010
Phase:
Study type: Observational [Patient Registry]

Rationale: Gathering medical information and tumor samples from patients with male breast cancer may help doctors learn more about the disease. Purpose retrospective part: to perform a large international retrospective analysis of clinical and biological data of male BC patients treated in the participating centers from 1990 to 2010. Purpose prospective part: to create a registry of men with breast cancer for a period of 30 months (starting early 2014).

NCT ID: NCT01099423 Active, not recruiting - Kidney Cancer Clinical Trials

Immediate Surgery or Surgery After Sunitinib Malate in Treating Patients With Metastatic Kidney Cancer

SURTIME
Start date: April 2010
Phase: Phase 3
Study type: Interventional

RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib malate before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving sunitinib malate after surgery may kill any tumor cells that remain after surgery. It is not yet known whether undergoing immediate surgery or surgery after sunitinib malate is more effective in treating patients with metastatic kidney cancer. PURPOSE: This randomized phase III trial is studying immediate surgery to see how well it works compared with surgery after sunitinib malate in treating patients with metastatic kidney cancer.

NCT ID: NCT01095172 Active, not recruiting - Clinical trials for Function of Renal Transplant

RituxiMab INDuction in Renal Transplantation

ReMIND
Start date: November 2010
Phase: Phase 4
Study type: Interventional

Hypothesis: - That B cell depletion, rather than reducing acute rejection, will allow minimisation of immunosuppression, which may lead to better graft survival. Aim: - To assess whether the addition of rituximab to a low-dose tacrolimus immunosuppression regime allows a reduction in steroid administration. Objectives: - To assess whether B cell depletion affects graft function, acute rejection and complication rates - To assess whether the T cell response to allotransplantation is impaired by B cell depletion.

NCT ID: NCT01081951 Active, not recruiting - Ovarian Cancer Clinical Trials

Study to Compare the Efficacy and Safety of Olaparib When Given in Combination With Carboplatin and Paclitaxel, Compared With Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer

Start date: February 4, 2010
Phase: Phase 2
Study type: Interventional

To compare the efficacy of olaparib in combination with paclitaxel and carboplatin (AUC4) when compared with carboplatin (AUC6) and paclitaxel alone in patients with advanced ovarian cancer.

NCT ID: NCT01081288 Active, not recruiting - Clinical trials for Breast Cancer Mortality

Extending the National Health Service (NHS) Breast Screening Age Range

AgeX
Start date: June 2009
Phase: N/A
Study type: Interventional

Nationwide cluster-randomised trial of extending the NHS breast screening age range in England

NCT ID: NCT01066377 Active, not recruiting - Influenza Clinical Trials

PRIMAGE (Probiotics, Immunity and Ageing)

PRIMAGE
Start date: April 2010
Phase: N/A
Study type: Interventional

Ageing dramatically affects immune function; this phenomenon is known as immunosenescence and partly explains the increased susceptibility for infection in older individuals. Vaccination is recommended to protect older people against influenza, but immunosenescence also reduces the efficacy of vaccination. Probiotics are beneficial bacteria, which can be consumed and which have a long and safe record of use in humans. Often they are taken together with prebiotics, which are carbohydrates that provide a food source for the beneficial bacteria when they reach the lower gut. There is particular interest in the positive influences of pre- and probiotics in older people, who are subject to alteration in gut microflora composition as well as immunosenescence. The PRIMAGE (Probiotics, immunity and ageing) study will examine the effect of a prebiotic and probiotic mix on the immune response to influenza vaccination in young and older subjects, and is funded by BBSRC DRINC. It will involve 60 young (18-35y) and 60 older (65-85y) subjects recruited from the local Reading community. Participants will take a pre- and probiotic mixture or a placebo for a total of 8 weeks. The probiotic is not currently commercially produced, but has been demonstrated to have particular ecological fitness and anti-pathogenic effects in the gastrointestinal tract in old age. A suitable prebiotic will be selected on the basis of ability to promote optimal growth and survival of this probiotic. After 4 weeks on the treatment, the subjects will receive an influenza vaccination. Blood, saliva and stool samples will be taken before treatment, and at 4, 6 and 8 weeks after commencement. The samples taken at 6 and 8 weeks will be used to assess the immune response to the vaccination. A wide range of immune parameters will be assessed, taking into account the age-related shifts in immune cell populations.

NCT ID: NCT01065454 Active, not recruiting - Clinical trials for Hypertension, Pulmonary

A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction

LEPHT
Start date: April 14, 2010
Phase: Phase 2
Study type: Interventional

The aim of this study is to assess whether increasing oral doses of Riociguat are safe and improve the well-being, symptoms and outcome in patients with pulmonary hypertension associated with left ventricular systolic dysfunction

NCT ID: NCT01064310 Active, not recruiting - Clinical trials for Carcinoma, Renal Cell

Patient Preference Study of Pazopanib Versus Sunitinib in Advanced or Metastatic Kidney Cancer

PISCES
Start date: May 2010
Phase: Phase 3
Study type: Interventional

This is a randomised, double-blind, cross-over study of pazopanib versus sunitinib in patients with locally advanced or metastatic renal cell carcinoma (mRCC) who have received no prior systemic therapy for advanced or metastatic RCC. Approximately 160 eligible patients will be stratified based on the ECOG performance status (0 vs. 1) and number of metastatic sites of disease (0 and 1 vs. >=2). The study consists of two treatment periods of 10 weeks with a 2-week wash-out period between the two treatment periods. Patients will receive pazopanib and sunitinib treatment sequentially in a double-blinded fashion. The primary objective of the study is to assess how the tolerability and safety differences between pazopanib and sunitinib translate into patient preference, defined by the patient's stated preference for which drug they may prefer to continue treatment with at end of study. The secondary objectives are to evaluate the reason for patient preference as assessed by a patient preference questionnaire; to evaluate fatigue as assessed by FACIT-Fatigue and quality of life as assessed by EuroQoL EQ-5D; to evaluate dose modifications and time to dose modification; and to evaluate safety.

NCT ID: NCT01064076 Active, not recruiting - Clinical trials for Tachycardia, Ventricular

S-ICD® System IDE Clinical Study

Start date: January 2010
Phase: N/A
Study type: Interventional

This clinical study is designed to evaluate the safety and effectiveness of the subcutaneous implantable defibrillator (S-ICD) System.