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NCT ID: NCT00885677 Terminated - Heart Failure Clinical Trials

MOnitoring REsynchronization deviCes and cARdiac patiEnts

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

The objective of this study is to compare two different strategies of disease management in heart failure patients treated with cardiac resynchronization therapy devices 1. Remote monitoring with CareLink Network System 2. Standard management of the disease by means of scheduled routine in-patient follow-ups; and to demonstrate that the remote monitoring strategy is superior to the standard strategy, both in terms of clinical effectiveness and total healthcare system utilization.

NCT ID: NCT00885599 Completed - Gingivitis Clinical Trials

Efficacy of a Naturally-derived Mouthrinse for Gingival Inflammation

Start date: June 2009
Phase: Phase 1/Phase 2
Study type: Interventional

Gingivitis, defined as inflammation of the gingival tissues, has long been associated with bacterial accumulation [plaque] on the tooth surface adjacent to the gingiva, causing an inflammatory reaction. Experimental gingivitis in health adults can be induced by abstension from brushing teeth for 9 to 21 days, and can test the effects of numerous chemotherapeutic agents, rinses and toothpastes. Effective prevention of plaque accumulation can prevent destructive forms of periodontal disease. A recent link has been established between localized gingival inflammation and systemic inflammation and a number of disease processes. Periodontal disease may lead to elevated C-reactive protein [CRP], considered a potential risk factor for cardiovascular disease and stroke. It has been shown that reducing gingival inflammation is accompanied with a significant decrease in serum CRP levels. Naturopathic remedies for treating oral disease have been well documented in the medical and dental literature since early civilization, and have become more and more popular in recent years. We propose to study one such remedy, PERIORINSE. This remedy consists of a number of herbs, and has been shown to exhibit antibacterial and anti—inflammatory effects. Specifically, it has been shown to block the proteolytic effects seen in gingival inflammation . This study will evaluate the efficacy of this formulation, using currently accepted clinical testing protocols. A Random sample of 100 healthy volunteers who fulfill all inclusion criteria and no exclusion criteria, will be included in the study. Patients will randomly selected to one of 4 treatment groups: PERIORINSE (n=25), CPC (Cepacol) mouthwash (25 patients), Listerine mouthwash (n=25), and placebo (colored water) mouthrinse. Patients will be examined at baseline, and Gingival Index taken for all teeth. A blood specimen will be taken to measure CRP levels as well. Patients will be given a full dental prophylaxis which includes scaling and tooth polishing, and given rinsing instructions and reminded to cease all other oral hygiene methods including brushing, flossing, and rinsing with any other rinse for a period of 14 days. On day 14, patients will be re-examined and Gingival Index taken for all teeth. Patients will be given a full dental prophylaxis which includes scaling and tooth polishing and required to reinstitute their original oral hygiene regimen. CRP levels will be measured again, as well.

NCT ID: NCT00885261 Completed - Clinical trials for Pain and Metabolic Syndrome

The Prevalence of Metabolic Syndrome in Patients Suffering From Chronic Pain

Start date: May 2009
Phase: N/A
Study type: Observational

Obesity is considered as the epidemic of the century. Central obesity is one of the metabolic syndrome's features. It has been proven that obesity can cause back pain and headaches; thus, there might be a link between chronic pain and the syndrome. The objective of this study is to assess the prevalence of metabolic syndrome in patients suffering from chronic pain.

NCT ID: NCT00885222 Completed - Clinical trials for Major Depressive Disorder

Antidepressant Effect of Deep Brain Stimulation in Parkinson's Disease Patients

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

The purpose of this study is: 1. To determine, in the context of a prospective clinical trial, whether stimulation parameters in PD patients treated with DBS, are associated with antidepressant effects. 2. To determine whether these antidepressant effects are related to or independent of changes in the motor features of PD. 3. To establish a computerized database that includes stimulation parameters and clinical parameters in PD patients treated with DBS. 4. To develop a computer-assisted decision making protocol for programming of DBS parameters in both depressed and non-depressed PD patients.

NCT ID: NCT00884988 Suspended - Fracture Clinical Trials

Lymphomyosot for Ankle Edema Following Fracture

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

Ankle fractures are invariably complicated by severe soft-tissue swelling which can significantly prevent surgical repair (open reduction and internal fixation - ORIF) of the fractured bone for up to two weeks. The delay in surgical treatment can increase the risk for local skin and bone complications, as well as for deep venous thrombosis. Lymphomyosot® is a non-prescription, homeopathic complex drug which has been used for more than 70 years throughout Europe and the U.S., primarily for tissue edema and swelling. This is a randomized, placebo-controlled, double blind pilot study evaluating the effectiveness of homeopathic combination drug Lymphomyosot® compared to placebo treatment. The study will take place at the Shaare Zedek Medical Center in Jerusalem, Israel. Adult patients (age 18 years and older) admitted to the orthopedic department with acute ankle fractures which require ORIF repair will be assessed for inclusion in this study. The primary outcome measure to be evaluated is the fracture-ORIF waiting period. Other measures to be evaluated are: peri-malleolar circumference; pain (as measured by NRS and analgesic use); duration of hospital stay; and complications such as poor wound healing, blisters, and the development of deep vein thrombosis.

NCT ID: NCT00884741 Completed - Glioblastoma Clinical Trials

Temozolomide and Radiation Therapy With or Without Bevacizumab in Treating Patients With Newly Diagnosed Glioblastoma

Start date: April 15, 2009
Phase: Phase 3
Study type: Interventional

This randomized phase III trial studies temozolomide (TMZ) and radiation therapy (RT) to compare how well they work with or without bevacizumab in treating patients with newly diagnosed glioblastoma or gliosarcoma. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as bevacizumab, may find tumor cells and help kill them. It is not yet known whether temozolomide and radiation therapy are more effective when given together with or without bevacizumab in treating glioblastoma or gliosarcoma.

NCT ID: NCT00884637 Completed - Clinical trials for Age Related Macular Degeneration

Correlation Between Visual Field Defects on FORESEE HOME and on Optical Coherence Tomography in Choroidal Neovascularization Subjects

Start date: June 2009
Phase: N/A
Study type: Observational

The FORESEE HOME is used in the recent years to detect Age-related Macular Degeneration (AMD) lesions. The device is capable of differentiation as to stages of AMD and early detection of changes including choroidal neovascularization (CNV) The Foresee HOME demonstrates a high level of sensitivity and specificity as to the different stages of AMD including newly diagnosed or early detection of CNV. The OCT May be use as well to identify choroidal neovascularization (CNV). Comparison between the two methods will allow better understanding of both devices. The FORESEE HOME can use as an assessment tool for the progression and success of the treatment given to AMD lesions. Therefore, evaluation the size and the location of the treated lesions may serve as an additional tool.

NCT ID: NCT00884624 Completed - Bowel Diseases Clinical Trials

Evaluation of the PillCamâ„¢ Colon Capsule -2 System

Start date: March 2009
Phase:
Study type: Observational

The purpose of this study is to evaluate the ability of the PillCam Colon Capsule 2 to detect polyps and other pathologies in the colon.

NCT ID: NCT00884585 Completed - Clinical trials for Atopic Conjunctivitis

Efficacy and Safety Study of Cyclosporine 0.010% to Treat Atopic Keratoconjunctivitis

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

This study evaluates the efficacy and safety of Cyclosporine 0.010% eye drops in the treatment of Atopic Keratoconjunctivitis (chronic and severe inflammation of the eye). The study consists of a double-masked phase, and open-labeled phase, and an open-labeled maintenance phase. For the first 3 months of the study, patients will receive either masked Cyclosporine 0.010% eye drops or vehicle four times daily; for the next 6 months, patients may receive open-labeled Cyclosporine 0.010% eye drops four times daily. At month 9, patients who are in remission, will be re-randomized to receive either open-labeled Cyclosporine 0.010% eye drops four times daily or twice daily.

NCT ID: NCT00884000 Completed - Clinical trials for Growth Hormone Deficiency

A Study of Zomacton in Children With Growth Hormone Deficiency

Start date: January 2010
Phase: Phase 3
Study type: Interventional

This trial is set up to compare Zomacton to Genotropin for the treatment of growth hormone deficiency in children. The children will be treated for 1 year. Half of the patients will be treated with Genotropin and half with Zomacton. During this time they will be dosed every day by themselves or their parents at home in the evening. There will be 138 patients in the trial from age 3 to age 11. The patients cannot have been treated before with growth hormone and the patients must have a proven growth hormone deficiency, this will be shown by a specific test that will be performed before the trial in the local clinic and once during the trial. During the time of the treatment the patients will come to visit the clinic every 3 months. At these visits their heights will be measured, blood samples will be taken, physical examinations will be performed and questions about their health will be asked. At 2 times in the trial they will have a hand x-ray taken to measure the bone age. At the end of the trial the patients will stop the treatment and continue on one of the marketed products available to treat growth hormone deficiency.