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NCT ID: NCT00876759 Recruiting - Brain Metastases Clinical Trials

Whole-Brain Radiotherapy (WBRT) Versus WBRT and Integrated Boost Using Helical Tomotherapy for Multiple Brain Metastases

Start date: April 2009
Phase: Phase 2
Study type: Interventional

Brain metastases occur in 20-40% of patients with primary extracerebral tumors. Despite important advances in therapy of malignant solid tumors and treatment of 1-3 brain metastases, multiple brain metastases continue to present a significant problem in attempting to prevent progression of disease and limit morbidity associated with therapy. The majority of patients who develop brain metastases have a short survival, effective palliation being transient. The median survival after diagnosis is as low as 3-6 months. However, there is some evidence that selected patients survive prolonged periods with vigorous therapeutic approach. Specific therapeutic options are surgery, chemotherapy, conventional fractionated whole-brain radiotherapy (WBRT) and radiosurgery. Radiosurgery allows delivering of a single high dose fraction of radiation to targets of 3-3.5 cm maximum diameter. In patients with newly diagnosed brain metastases, a rapid decrease of symptoms, local tumor response rate of 73-90% and a median survival of 7-12 month have been reported. WBRT alone is the treatment of choice for patients with multiple brain metastases, and for patients with single brain metastases not amenable to surgery or radiosurgery. Median survival after WBRT alone is 3-6 months. WBRT and radiosurgery boost have been shown to improve survival in RPA class I patients and in patients with favorable histological status and squamous cell or non-small cell lung tumors. All randomized trials showed improved local control with the addition of radiosurgery to WBRT (Andrews, 2004). WBRT in conjunction with radiosurgery improves local control and reduces the risk of new distant brain metastases, but most studies support that combined radiosurgery and WBRT does not improve the overall survival expect for patients without evidence of extracranial disease. Helical Tomotherapy (HT) allows as a sole modality a new treatment option: Using HT, the advantage of applying a highly conformal boost dose to the metastases and WBRT can be combined in one treatment session. Therefore, it allows applying a high dose to multiple brain metastases in the sense of an integrated boost. The focus of this study is to investigate the efficacy and safety of WBRT with an integrated boost using this new treatment modality in comparison to the effects of conventional WBRT alone. The principal objective of the trial is to assess the therapeutic efficacy of WBRT as compared to WBRT combined with integrated boost with HT delivered to patients with 2-10 brain metastases of solid tumors. The secondary objective is to evaluate the safety of WBRT as opposed to WBRT combined with integrated boost as delivered by HT in patients with 2-10 brain metastases.

NCT ID: NCT00876551 Recruiting - Clinical trials for Esophageal Neoplasms

Endoscopic-vacuum Assisted Closure of Intrathoracic Postsurgical Leaks

EVACoIL
Start date: January 2008
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the short and long term outcome of endoscopic vacuum assisted closure of intrathoracic postsurgical leaks.

NCT ID: NCT00875186 Recruiting - Morbid Obesity Clinical Trials

The Influence of Aerobic Endurance Training After Roux-en-Y-Gastric Bypass

AET
Start date: October 2006
Phase: N/A
Study type: Observational

The aim of this study was to assess the efficiency of aerobic physical exercise (APE) on weight loss, body composition and co-morbidities in patients after laparoscopic Roux-en-Y Gastric bypass (RYGBP).

NCT ID: NCT00869817 Recruiting - Alzheimer's Disease Clinical Trials

Dominantly Inherited Alzheimer Network (DIAN)

DIAN
Start date: January 2009
Phase:
Study type: Observational

The purpose of this study is to identify potential biomarkers that may predict the development of Alzheimer's disease in people who carry an Alzheimer's mutation.

NCT ID: NCT00869011 Recruiting - Clinical trials for Renal Cell Carcinoma

Exercise for Patients With Renal Cell Cancer Receiving Sunitinib

Start date: December 2009
Phase: Phase 3
Study type: Interventional

In this randomized, controlled trial the investigators evaluate the effects of an exercise program lasting for 12 weeks on the physical performance, the cardiovascular function (24h blood pressure, rest blood pressure and hear function) and the fatigue and mood of patients with renal cell carcinoma undergoing a therapy with Sunitinib.

NCT ID: NCT00866541 Recruiting - Healthy Clinical Trials

Flow Proportional Pressure Support in Volunteers

Start date: January 2009
Phase: N/A
Study type: Interventional

Flow proportional pressure support (FPPS) is a new mode of spontaneous breathing assistance. In patients with increased respiratory resistance the role of FPPS in comparison with the pressure support assist breathing mode is still unclear. In this study the investigators evaluate objective and subjective measured data in healthy volunteers with artificial increased resistance and FPPS breathing assistance.

NCT ID: NCT00865917 Recruiting - Clinical trials for Postural Orthostatic Tachycardia Syndrome

Cardiovascular Effects of Selective I(f)-Channel Blockade

Start date: November 2008
Phase: Phase 2
Study type: Interventional

The study compares three treatment modalities in a human model of Postural orthostatic tachycardia syndrome (POTS): beta-blockers, I(f)-blockers, and placebo.

NCT ID: NCT00862160 Recruiting - Clinical trials for Coronary Artery Disease

Incidence of Acute Cerebrovascular Events Using Either Minimized or Standard Cardiopulmonary Bypass Circuit

ROCsafeTM
Start date: April 2009
Phase: Phase 4
Study type: Interventional

The prospective, randomized, two centre study investigates acute cerebrovascular events during extracorporal circulation and the early post operative outcome when using either the minimized cardiopulmonary bypass circuit (ROCsafeTM) or a standard cardiopulmonary bypass circuit in patients undergoing coronary artery bypass grafting.

NCT ID: NCT00859885 Recruiting - Stroke Clinical Trials

International PFO Consortium

Start date: September 8, 2008
Phase: N/A
Study type: Observational

The prevalence of patent foramen ovale (PFO) is about 25% in the general population and approximately 40% in patients who have ischemic stroke of unknown cause (cryptogenic stroke). Given the large number of asymptomatic patients, no primary prevention is currently recommended. On the contrary, secondary prevention is very important. Prospective studies have shown that antithrombotic treatment (ATT) with aspirin or warfarin appears to negate the risk of recurrent stroke associated with a PFO. Patients with spontaneous or large right-to-left shunts (RLS), those with a coinciding atrial septal aneurysm (ASA) or multiple ischemic events prior to the PFO diagnosis may still be at increased risk of stroke recurrence despite ATT. Percutaneous device closure (PDC) is a challenging alternative to ATT. Several studies reported 0% to 3.4% annual recurrence rates of stroke or TIA in patients treated by PDC. To date, there is no data from randomized controlled trials (RCT) comparing the risk of stroke recurrence after PDC with that under ATT only. The results from ongoing RCTs are not to be awaited in the near future, mainly due to low enrolment and event rates. Alternative data-gathering strategies such as multicenter registries are needed to overcome the low recruitment rates. The aim of the present study is to compare the risk of recurrent stroke and TIA in patients with PFO and otherwise unexplained stroke who undergo PDC or receive ATT.

NCT ID: NCT00856505 Recruiting - Clinical trials for Hematologic Diseases

Safety Study of Calcineurin Inhibitor Free GvHD Prophylaxis in Allogeneic Stem Cell Transplantation

Start date: March 2008
Phase: Phase 1/Phase 2
Study type: Interventional

In stem cell transplantation as treatment for malignant diseases, calcineurin inhibitors like cyclosporine A are commonly used to prevent tissue destruction (GvHD) by activated donor immune cells. The hypothesis for this study is, that replacing calcineurin inhibitors by everolimus and mycophenolate as GvHD prophylaxis not only reduces toxicity of the treatment but also improves tolerance induction of the donor T cells toward the host, eventually increasing the safety of stem cell transplantation.