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NCT ID: NCT01611233 Active, not recruiting - Osteoarthritis Clinical Trials

Massachusetts General Hospital Evaluation of DePuy ASR Hip System

Start date: September 2012
Phase:
Study type: Observational

DePuy Orthopaedics has issued a voluntary recall of the ASR hip replacement system due to a higher than expected revision rate reported in the England/Wales and Australian national joint registries. There are two types of ASR hip implants used for total hip replacement surgery: - ASR XL Hip System - ASR Hip Resurfacing System Massachusetts General Hospital (MGH) in Boston, USA is the study sponsor. MGH is conducting this study with the help of funding from DePuy Orthopaedics. MGH will collect and analyze clinical information from 5,000 subjects around the world. The countries include the United States of America, Australia, South Africa, England, Denmark, Finland and Sweden. MGH will collect and analyze blood test results, X-rays, soft tissue imaging and how well the ASR hips are functioning. MGH will analyze the data annually for 6 years. The purpose of this study is to follow patients who have the ASR hip system for the next 6 years. The findings of this study may help surgeons to make better informed decisions about monitoring and treatment of patients with ASR hip systems.

NCT ID: NCT01610635 Active, not recruiting - Blood Donation Clinical Trials

INTERVAL Study: To Determine Whether the Interval Between Blood Donations in England Can be Safely and Acceptably Decreased

INTERVAL
Start date: June 2012
Phase: N/A
Study type: Interventional

It is hypothesised that the number of donations made by English blood donors will be greater with reduced vs. standard inter-donation intervals. The null hypothesis is that there will be no difference in donations between treatment groups; this may arise if reduced inter-donation intervals result in a greater number of donation deferrals (due to low haemoglobin) and/or an unacceptable burden to donors.

NCT ID: NCT01609465 Active, not recruiting - Clinical trials for Stable Coronary Artery Disease

Prognostic Models for People With Stable Coronary Artery Disease

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

There is currently no published algorithm for secondary prevention prognosis of CHD that is representative of the England GP-registered population and that includes both symptomatic and asymptomatic patients (as identified through primary care). In this paper the investigators will exploit routinely collected information in clinical practice to model CHD prognosis based on a large contemporary open cohort of stable CAD patients. Although the investigators model is based on data from GP practices in England only, the investigators believe that this population is sufficiently heterogeneous in terms of ethnic mix, socioeconomic background, predisposing characteristics and lifestyles to generate a prognostic model with good generalizing power to the wider population. Among the research questions the investigators will try to answer is whether established risk factors for primary care prevention (smoking, hypertension, dyslipidaemia, diabetes) are also reliable for risk-stratification of patients who have already developed CAD. Similarly, the investigators will examine whether strong predictors of adverse outcomes in ACS patients in the short term, such as admission SBP and heart rate, are also associated with their long term prognosis.

NCT ID: NCT01602380 Active, not recruiting - Clinical trials for Hormone Receptor Positive Breast Cancer

A Global Study to Compare the Effects of Fulvestrant and Arimidex in a Subset of Patients With Breast Cancer.

FALCON
Start date: October 17, 2012
Phase: Phase 3
Study type: Interventional

The purpose of the study is to compare how treatment with Fulvestrant (FASLODEX) or Anastrozole (ARIMIDEX) effects disease progression for women with locally advanced or metastatic breast cancer who have not had prior hormonal treatment.

NCT ID: NCT01599559 Active, not recruiting - Clinical trials for Primary Mediastinal B-cell Lymphoma

Randomized, Open-label, Two-arms, Phase III Comparative Study Assessing the Role of Involved Mediastinal Radiotherapy After Rituximab Containing Chemotherapy Regimens to Patients With Newly Diagnosed Primary Mediastinal Large B-Cell Lymphoma

Start date: October 2012
Phase: N/A
Study type: Interventional

Primary mediastinal large B cell lymphoma is treated with a combination of chemotherapy and the monoclonal antibody rituximab (chemoimmunotherapy). Following chemoimmunotherapy patients receive radiation therapy if they have residues which may be active tumour. However at the end of chemoimmunotherapy the majority of patients show tissue scarring that is not necessarily active tumor. In recent years, PET/CT has proved to be a good tool to accurately identify active tumor from scar tissue in patients treated for mediastinal lymphoma.The purpose of this trial is to test whether radiation therapy is really necessary in patients where PET/CT has shown that the tumor is no longer active. Therefore we will compare radiation treatment with careful observation. Patients that at the end of conventional treatment of chemoimmunotherapy have a negative PET/CT (i.e., without residues suspected to contain active tumor), will randomly assigned to two different treatment groups: one treatment group will receive the radiation treatment, and the other treatment group will receive careful observation. The trial is planned according to a non-inferiority design aimed at demonstrating that progression free survival after the experimental treatment (observation) is not worse than after the standard comparator (mediastinal irradiation.Participation in this study could spare patients with complete remission at the end of chemo immunotherapy (PET/CT negative) radiation therapy that may be unnecessary.

NCT ID: NCT01590134 Active, not recruiting - Healthy Clinical Trials

The Efficacy and Safety of Iron Supplementation

Start date: March 2012
Phase: N/A
Study type: Interventional

Each year, 5 million packs of iron tablets are dispensed in England and Wales to treat anaemia due to iron deficiency. Iron tablets are not always easy to take. The investigators think that there could be ways to reduce the number of iron tablets needed, by increasing the dietary intake of iron. In this study the investigators will assess the efficacy and safety of a dietary iron supplement compared to iron tablets using controls and new biomarkers.

NCT ID: NCT01589965 Active, not recruiting - Clinical trials for Sexually Transmitted Diseases

The Impact of Short-term Financial Incentives on Sexual Behavior and HIV Incidence in Lesotho

Start date: February 2010
Phase: Phase 0
Study type: Interventional

The HIV/AIDS epidemic is a major concern in many countries. The epidemic is especially acute in Lesotho where roughly one quarter of the population is infected by HIV/AIDS. In Lesotho, and elsewhere, new innovative approaches to induce safer sexual behavior have been desperately called for, particularly in view of the limited impact that existing prevention schemes have had on the trajectory of the HIV/AIDS epidemic. One of the key questions is to understand why individuals get involved in short-term risky sexual behavior when the potential long-term cost of becoming HIV infected is so high? A follow-up question is what replicable and feasible interventions can affect this trade-off between short and long run returns? The primary aim of this study is to evaluate whether the use of short-term financial incentives can affect this trade-off, thereby influencing young individuals' decisions with respect to sexual and reproductive health behavior, and thus in the end reduce HIV incidence rates. The investigators will study this question using a sample of population attending served by New Start Voluntary Counseling and Testing (VCT) sites that a local NGO, Population Service International (PSI), has already implemented in Lesotho. The investigators propose to conduct a randomized controlled trial to test whether adding a financial incentive to remain STI-negative in the form of a lottery can promote safer sexual activity. The lotteries will work as follows: if the individual is tested negative on a set of curable STIs, she will get a lottery ticket with the chance to win a "big" prize. If she is tested positive, she will receive free treatment, but no lottery ticket. If an individual who tested positive is cured, she can come back in the lottery system and get a later chance to win the lottery ticket if she remains STI-negative. The outcome will be to measure the impact of financial incentives on HIV incidence after two years. The results of this research project will be disseminated through academic and non-academic conferences, workshops, publications in academic journals, and also in policy journals with the aim to reach out to policy makers outside the research community.

NCT ID: NCT01589809 Active, not recruiting - Clinical trials for Neurodegenerative Disorders

Effect of Nicotinamide in Friedreich's Ataxia

Start date: June 2012
Phase: Phase 2
Study type: Interventional

The purpose of the interventional study is to determine whether Nicotinamide is effective at upregulating the Frataxin (FXN) gene in patients with Friedreich's ataxia (FRDA) where this gene is abnormally 'switched off'. The purpose of the non-interventional study is to investigate the use of novel, highly-sensitive technology to capture clinical deficit and measure subtle changes in the activities of daily living and to correlate functional changes to levels of expression of Frataxin protein and the epigenetic structure of the Frataxin gene over a 9-12 month period without nicotinamide. Healthy volunteers will be included as comparators in this part of the study.

NCT ID: NCT01586910 Active, not recruiting - Clinical trials for Severe Aortic Stenosis

Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).

SURTAVI
Start date: April 2012
Phase: N/A
Study type: Interventional

The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgical Aortic Valve Replacement (SAVR) or TAVI with the Medtronic CoreValve® System. Single Arm: The purpose of this trial is to evaluate the safety and effectiveness of transcatheter aortic valve implementation (TAVI) in patients with severe symptomatic Aortic Stenosis (AS) at intermediate surgical risk with TAVI. This is a non-randomized phase of the pivotal clinical trial.

NCT ID: NCT01584258 Active, not recruiting - Prostate Cancer Clinical Trials

Prostate Advances in Comparative Evidence

PACE
Start date: August 7, 2012
Phase: Phase 3
Study type: Interventional

This study is an international multicentre randomised study of low, intermediate, and high risk prostate cancer and is composed of three parallel randomisation schemes based on applicability of surgery as a treatment for the patient and risk group. Low and intermediate risk patients, for whom surgery is a consideration, are randomised to either prostatectomy or prostate SBRT. Low and intermediate risk patients, for whom surgery is not a consideration, are randomised to either conventionally fractionated radiotherapy or prostate SBRT. Intermediate and high risk patients, for whom ADT treatment is indiacted and surgery is not a consideration, are randomised to either conventionally fractionated radiotherapy or prostate SBRT. Efficacy, toxicity and quality of life outcomes will be compared across the pairs in each randomisation.