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NCT ID: NCT00464061 Terminated - Clinical trials for Sleep Initiation and Maintenance Disorders

Efficacy an Safety of Volinanserin on Sleep Maintenance Insomnia With a Sub-study on Stable Type II Diabetes Mellitus

SAMS
Start date: April 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess efficacy and safety of volinanserin in the population of patients complaining of sleep maintenance insomnia. The objective of the substudy is to assess glycemic control in the subgroup of patients with type II diabetes mellitus.

NCT ID: NCT00458276 Terminated - Heart Diseases Clinical Trials

Study of the Efficacy and Safety of Tezosentan in Patients With Pre-operative Pulmonary Hypertension, Due to Left Heart Disease, Undergoing Open Heart Surgery

Start date: April 2007
Phase: Phase 3
Study type: Interventional

Endothelin-1 is a powerful substance that may be involved in causing hemodynamic instability (problems related to unstable blood pressure) during and after open heart surgery. Tezosentan is an investigational intravenous drug that blocks the endothelin receptors. This clinical trial will assess the potential benefit of tezosentan compared with placebo in the treatment of patients undergoing open heart surgery with cardiopulmonary bypass (CPB). Treatment time is from the start of surgery up to 24 hours.

NCT ID: NCT00452478 Terminated - Kidney Diseases Clinical Trials

Conversion From Standard Phosphate Binder Therapy to Fosrenol® (Lanthanum Carbonate) in Chronic Kidney Disease Stage 5

Start date: May 22, 2007
Phase: Phase 4
Study type: Interventional

The main aim of this research study is to see if giving Fosrenol®, a chewable tablet, to patients on haemodialysis works as well as other treatments currently used to lower blood phosphorus levels.

NCT ID: NCT00452140 Terminated - Clinical trials for Metastatic Breast Cancer

Phase II Study With the Trifunctional Antibody Ertumaxomab to Treat Metastatic Breast Cancer Progressing After Endocrine Treatment

Start date: March 2007
Phase: Phase 2
Study type: Interventional

The purpose of the study is to demonstrate clinical efficacy of the investigational trifunctional bispecific antibody ertumaxomab for treatment of patients with HER-2/neu 1+ or 2+ (FISH-) expressing advanced or metastatic breast cancer (stage III b/IV) which has progressed after endocrine therapy. Ertumaxomab is a trifunctional bispecific antibody targeting Her-2/neu and CD3 on T cells. Trifunctional antibodies represent a new concept for targeted anticancer therapy. This new antibody class has the capability to redirect T cells and accessory cells (e.g. macrophages, dendritic cells [DCs] and natural killer [NK] cells) to the tumor site. According to preclinical data, trifunctional antibodies activate these immune cells, which can trigger a complex anti-tumor immune response.

NCT ID: NCT00450333 Terminated - Anemia Clinical Trials

Dynepo Infrequent Dosing Study

Start date: October 30, 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate non-inferiority of efficacy between twice weekly and once weekly dose schedule of Dynepo in previously erythropoietin (EPO)-naive patients, as measured by haemoglobin at week 24 and secondly to demonstrate the non-inferiority of efficacy between once weekly and once every two weeks dose schedules of Dynepo in patients previously stable on EPO, as measured by Hb over Weeks 16 to 24.

NCT ID: NCT00444249 Terminated - Clinical trials for Macular Degeneration

Influence of Blue Light Filtering Intraocular Lenses on Daytime Levels of Melatonin

BluMel
Start date: March 2007
Phase: N/A
Study type: Interventional

The "blue light hazard" has been reported to cause retinal damage (oxidative stress), particularly to the central fovea due to its energetic, shorter wavelength visible photons, which is why blue-light filtering intraocular lenses have been developed for cataract surgery. The hormone melatonin has been reported to possess an efficient antioxidant capacity. Light information from the eye reaches the suprachiasmatic nuclei and inhibits melatonin secretion. Since melatonin is suppressed by light, we have a day-night rhythmicity, with increased levels at night. Melatonin suppression is wavelength-dependent with a peak sensitivity in the 446-477 nm (blue light) portion of the visible spectrum. The crystalline lens blocks most UV between 300 and 400 nm. The density of the lens increases with aging causing an alteration in the spectral absorption. The greatest increase in absorption occurs at the short wavelength end of the spectrum (around 400-470 nm). Age-related pupillary miosis and crystalline lens yellowing limit the blue light reaching the retina. This reduces the older adults' effective retinal light exposure to one tenth that of younger people. It has been shown that insomnia and depression decrease after cataract surgery and patients returned to youthful levels of melatonin. Since melatonin acts as an antioxidant, and more blue light filtering intra ocular lenses are implanted and thought to reduce photochemical damage in the macula, it would be interesting to show the positive influence of those blue light filtering intraocular lenses on daytime levels of melatonin in age-related macular degeneration patients.

NCT ID: NCT00437697 Terminated - Clinical trials for Venous Thromboembolism

Thromboprophylaxis in Critically Ill Patients

Start date: April 2003
Phase: Phase 4
Study type: Interventional

Intensive care patients are at high risk to develop deep venous thrombosis and pulmonary embolism. Despite anticoagulation with heparin 7% of ICU patients suffer from this serious complication. Optimal regimens for prevention of VTE have been established in medical patients only and are not known for ICU patients. It was therefore the aim of this study to compare the bioavailability of a low molecular weight heparin in ICU patients and in medical patients. Furthermore, we looked wether a 50% dose increase resulted in better bioavailability of this drug.

NCT ID: NCT00437073 Terminated - Neoplasms, Breast Clinical Trials

Brain Metastases In ErbB2-Positive Breast Cancer

Start date: May 2007
Phase: Phase 2
Study type: Interventional

This study is for patients with ErbB2 overexpressing breast cancer that has spread to the brain and is still progressing there even after radiation treatment using WBRT (whole brain radiotherapy) or SRS (stereotactic radiosurgery) to the brain. The study will determine how safe and effective lapatinib is when given in combination with capecitabine to treat patients with ErbB2 overexpressing breast cancer that has spread to the brain. Lapatinib is an oral drug that will be taken every day. Tests for safety and efficacy will be performed regularly during the course of the study.

NCT ID: NCT00433017 Terminated - Clinical trials for Macular Degeneration

Verteporfin Photodynamic Therapy Administered in Conjunction With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration (AMD)

Start date: May 2007
Phase: Phase 2/Phase 3
Study type: Interventional

This study will evaluate the effect of combination therapy with verteporfin photodynamic therapy and ranibizumab on visual acuity compared to ranibizumab monotherapy and the durability of response observed in patients with choroidal neovascularization secondary to age-related macular degeneration

NCT ID: NCT00419913 Terminated - Infertility Clinical Trials

A Trial of Dehydroepiandrosterone (DHEA) Treatment for in Vitro Fertilization (IVF)

Start date: January 2007
Phase: Phase 2/Phase 3
Study type: Interventional

Our long term goal is to elucidate the role of DHEA on follicular dynamics in the human ovary and to better understand the interaction of DHEA supplementation with other treatments for ovulation induction, especially among older reproductive age women. The specific hypothesis behind the proposed research is that DHEA is a regulator of follicular dynamics acting in the early pre-gonadotropin dependent stage of initial primordial follicle recruitment and growth.