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NCT ID: NCT01420679 Terminated - Clinical trials for Peripheral T-cell Lymphoma

Pralatrexate vs Observation Following CHOP-based Chemotherapy in Undiagnosed Peripheral T-cell Lymphoma Patients

Start date: August 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to see if pralatrexate extends response and survival following CHOP-based chemotherapy (CHOP: cyclophosphamide, doxorubicin, vincristine, and prednisone) and if pralatrexate improves response in patients with partial response following CHOP-based chemotherapy. Patients will either receive pralatrexate or be under observation. All patients will receive vitamins B12 and folic acid and attend regular clinic visits to evaluate their disease and health.

NCT ID: NCT01420081 Terminated - Clinical trials for Endometrial Neoplasms

A Study Of Two Dual PI3K/mTOR Inhibitors, PF-04691502 And PF-05212384 In Patients With Recurrent Endometrial Cancer

Start date: January 19, 2012
Phase: Phase 2
Study type: Interventional

This study will investigate the individual safety and efficacy of two dual PI3K/mTOR inhibitors in patients with recurrent endometrial cancer.

NCT ID: NCT01416012 Terminated - Disease Alzheimer Clinical Trials

Health Related Quality of Life Effects of Off-the-shelf Computer Gaming in Alzheimer and Related Disorders Populations

Start date: October 2011
Phase: N/A
Study type: Interventional

Interactive games (virtual reality) have recently been the center of interest and scientific discussion in the field of cognitive and functional rehabilitation. From their entertaining and contextual aspects, off-the-shelf video games are potentially interesting tools as adjunct to the patient care, especially for maintaining instrumental activities of daily living (IADL) autonomy. Disease and physical inactivity worsen the patient's ability in the IADLs, thus reducing health related quality of life (HRQL). This decrease in cognitive and functional abilities can be slowed down using adapted rehabilitation program. However, there is no randomized controlled study comparing usual physical therapy to virtual reality gaming consoles such as the Nintendo Wii or the Xbox 360 Kinect. Off-the-shelf gaming consoles offer a large range of games where cognitive and functional abilities from geriatric patients could be stimulated and consequently HRQL improved. However, a better knowledge of the potential cognitive and functional improvement processes from virtual reality rehabilitation in institutional routine is needed to enhance the quality and the range of the available care in old adults. This study will not only be a validation platform of virtual reality as stand alone rehabilitation process but also will assess the cost effectiveness of off-the-shelf gaming consoles in HRQL improvement of old adults. The investigators will compare the efficacy of two off-the-shelf gaming consoles in HRQL changes of patients with Alzheimer disease and related disorders. •Method This study is a randomized controlled trial that comprises two study phases : Phase one; comparing three parallel groups where therapists and assessors will be kept blind of study objectives, and Phase two, the investigators will take the most cost-effective gaming console from phase one (Nintendo Wii or Xbox 360 Kinect) and the investigators will use it as an adjunct to physical therapy compared to physical therapy alone, with respect to the same amount of rehabilitation time. The interventions are of 120min/week for 6 weeks and a follow-up at 4 weeks after intervention. Patients will be randomized in either Xbox 360 Kinect group - a Nintendo Wii group - or physical therapy as the 'gold' standard condition. All groups will receive the same amount of rehabilitation time. Power and sample calculation for phase two will be based on phase one results.

NCT ID: NCT01403064 Terminated - Oral Mucositis Clinical Trials

Safety and Efficacy of ALD518 for Reducing Oral Mucositis in Head and Neck Cancer Subjects

Start date: July 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of ALD518 in modifying the course of oral mucositis in subjects with head and neck cancer receiving concomitant chemotherapy and radiotherapy

NCT ID: NCT01399593 Terminated - Clinical trials for Antibody Mediated Rejection

Safety & Efficacy of Eculizumab to Prevent AMR in Living Donor Kidney Transplant Recipients Requiring Desensitization

Start date: November 2, 2011
Phase: Phase 2
Study type: Interventional

The purpose of this trial was to determine the safety and efficacy of eculizumab in the prevention of antibody-mediated rejection (AMR) in sensitized recipients of a living donor kidney transplant requiring desensitization therapy.

NCT ID: NCT01392495 Terminated - Clinical trials for Pulmonary Arterial Hypertension

Extension to CQTI571A2102 to Evaluate Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)

Start date: June 2011
Phase: Phase 3
Study type: Interventional

This study was an extension to study CQTI571A2102 and was to evaluate the long-term safety, tolerability and efficacy of QTI571 (imatinib) in severe pulmonary arterial hypertension patients.

NCT ID: NCT01392196 Terminated - Heart Failure Clinical Trials

Renal Denervation in Patients With Chronic Heart Failure & Renal Impairment Clinical Trial

SymplicityHF
Start date: October 2011
Phase: N/A
Study type: Interventional

This is a feasibility study enrolling up to 40 patients in Australia and Europe. The primary aim of the study is to demonstrate the renal denervation with the Symplicity Catheter is safe and determine the evidence of a response to renal denervation in patients with Heart Failure.

NCT ID: NCT01391377 Terminated - Clinical trials for Peripheral Arterial Disease

Effects of Niacin on Good Cholesterol in People With Peripheral Arterial Disease

Start date: July 2011
Phase: N/A
Study type: Interventional

Atherosclerosis is a disorder in the body that is characterized by cholesterol plaque formation in various arteries, causing narrowing of the artery and a limitation in blood flow. Depending on which artery the plaque is in, different clinical conditions occur. In adults common areas include in the heart arteries, in the neck arteries and in the aorta and lower leg arteries. When it affects the lower limbs it is known as peripheral arterial disease - PAD. The main symptom of PAD is called "claudication" and is described as pain or discomfort in the legs when walking. The aim of PAD treatment is to improve walking distance and quality of life in those with intermittent claudication, and to decrease long term complications including illness and death. An important controlling factor of these cholesterol plaques is a type of cholesterol called HDL (High density lipoprotein). This study aims to look at the effect that raising HDL for a prolonged period has on blood markers of inflammation and on the cholesterol plaque composition in patients with PAD. This investigation will also have relevance to the effects of HDL elevation on plaque composition and inflammation in other areas of the body including the heart, neck and brain arteries. Twenty (20) PAD patients with will be recruited into the study. The investigators anticipate recruitment of all 20 patients within 12 months. The 20 PAD patients all must have significant leg pains when walking, and after review by a doctor, be determined to have narrowings in the leg artery that they will plan to operate on. Patients will be randomized to either niacin (Tredaptive, 1g/day) or matching placebo for 8 weeks (prior to operation) After the 8 week period they will then go on to receive the normal interventional treatment as planned. Blood samples will be taken at enrollment and at the 8 week mark prior to surgery. The plaque that is removed at the time of operation will also be sent to the lab for analysis. The investigators hope to show with this study that by raising the levels of HDL with extended release niacin, there are positive effects on the amount of cholesterol in the plaque, and on the markers in the blood of inflammation and thrombosis. The hypothesis is that elevation of HDL with Niacin will have anti-atherosclerotic actions including: Lower plaque lipid content, Reduced plaque macrophage infiltration, Reduced monocyte activation, Reduced neutrophil adhesion, Inhibition of inflammation and Inhibition of thrombotic markers.

NCT ID: NCT01390220 Terminated - Epilepsy Clinical Trials

Study to Evaluate the Safety and Efficacy of USL261 (Intranasal Midazolam) in Patients With Seizure Clusters

ARTEMIS1
Start date: June 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to examine the safety and effectiveness of USL261 for the outpatient treatment of seizure clusters.

NCT ID: NCT01389895 Terminated - Lupus Clinical Trials

Safety Study of AMG 557 in Subjects With Subacute Cutaneous Lupus Erythematosus

Start date: October 2011
Phase: Phase 1
Study type: Interventional

This study will be a multicenter, randomized, double-blind, placebo-controlled, multiple dose study in which approximately 24 subjects with SCLE will be enrolled. Cohort 1 will consist of 12 subjects (6 AMG 557: 6 placebo) randomized to receive AMG 557 210 mg or matching placebo. Cohort 2 will consist of 12 subjects (6 AMG 557: 6 placebo) randomized to receive AMG 557 140 mg or matching placebo. Enrollment of Cohort 2 (140 mg) will be initiated after enrollment of Cohort 1 (210 mg) is completed.