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NCT ID: NCT00976911 Completed - Ovarian Cancer Clinical Trials

AURELIA: A Study of Avastin (Bevacizumab) Added to Chemotherapy in Patients With Platinum-resistant Ovarian Cancer

Start date: October 29, 2009
Phase: Phase 3
Study type: Interventional

This randomized, open-label, 2-arm study will evaluate the efficacy and safety of Avastin added to chemotherapy versus chemotherapy alone in patients with epithelial ovarian, fallopian tube or primary peritoneal cancer with disease progression within 6 months of platinum therapy. All patients will receive standard chemotherapy with either paclitaxel or topotecan or liposomal doxorubicin. Patients randomized to Arm 2 of the study will receive Avastin (10 mg/kg iv 2-weekly or 15 mg/kg iv 3-weekly) concomitantly. Anticipated time on study treatment is until disease progression. Patients will then receive standard of care, those in Arm 1 (chemotherapy only) may opt to receive Avastin (15 mg/kg iv 3-weekly). Target sample size is 100-500 individuals.

NCT ID: NCT00976521 Completed - Clinical trials for Acute Anterior Myocardial Infarction

The INFUSE - Anterior Myocardial Infarction (AMI) Study

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

This is a multicenter, open-label, controlled, single-blind, randomized study with up to 452 subjects enrolled in up to 50 US and European sites. Subjects who present with anterior ST-elevation myocardial infarction (STEMI) and an occluded proximal or mid left anterior descending (LAD) with TIMI 0/1/2 flow will be eligible for randomization to one of the following arms: 1. Local infusion of abciximab following thrombus aspiration 2. Local infusion of abciximab and no thrombus aspiration 3. No local infusion and thrombus aspiration 4. No local infusion and no thrombus aspiration In addition, a cardiac magnetic resonance imaging (MRI) sub-study evaluating microvascular obstruction (MVO) will be performed with up to 160 subjects at up to 20 sites.

NCT ID: NCT00976495 Completed - Clinical trials for Type 2 Diabetes Mellitus

Effects of Dapagliflozin on Kidney Function (Glomerular Filtration Rate) in Subjects With Type 2 Diabetes

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

The purpose of this study is to evaluate the effects of dapagliflozin on kidney function, as assessed by glomerular filtration rate.

NCT ID: NCT00975858 Completed - Clinical trials for Coronary Artery Disease

Long-term Comparison of Stenting Versus Off-pump Coronary Bypass Surgery

OCTOSTENT
Start date: January 1998
Phase: N/A
Study type: Interventional

The randomized comparison of two strategies in coronary revascularization: bypass surgery without the use of a heart lung machine and coronary stenting procedure. The comparison comprised the occurrence of cardiac adverse events after the procedure. In addition, costs, cognitive outcomes and angiography were assessed.

NCT ID: NCT00975429 Completed - Prostate Cancer Clinical Trials

Study Using WST11 in Patients With Localized Prostate Cancer

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

The aim of this trial is to determine the optimal treatment conditions to achieve prostate cancer tumour ablation and to assess the effects of WST11-mediated Vascular-Targeted Photodynamic therapy (VTP) treatment in patients with localized prostate cancer. The secondary objectives are to assess the safety and quality of life following WST11-mediated VTP treatment,to assess the effects,safety and quality of life following a second WST11-mediated VTP treatment; and to explore optimisation techniques to reduce the duration of the VTP procedure.

NCT ID: NCT00975390 Completed - Exercise Recovery Clinical Trials

Muscle Glycogen Synthesis When Caffeine and Protein is Co-Ingested With Carbohydrates

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

The aim of the present study is to investigate the effect of added protein+leucine or caffeine to 1.2 g/kg/h CHO on the rate of post-exercise muscle glycogen re-synthesis in healthy, recreational athletes. The investigators hypothesize that both interventions (the addition of caffeine or protein+leucine) will lead to higher glycogen re-synthesis compared to the ingestion of CHO only, and that the co-ingestion of protein and leucine will result in the highest muscle glycogen synthesis rates.

NCT ID: NCT00975286 Completed - Clinical trials for Type 2 Diabetes Mellitus

24-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin Glargine

GetGoal Duo1
Start date: October 2009
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to insulin glargine and metformin with or without thiazolidinediones (TZDs), over a period of 24 weeks of treatment. The primary objective is to assess the effects of lixisenatide in comparison to placebo, when added to insulin glargine and metformin, on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. The secondary objectives are to assess the effects of lixisenatide on the percentage of patients reaching HbA1c less than (<) 7 percent (%) and less than or equal to (<=) 6.5%, plasma glucose (fasting, postprandial during a standardized meal challenge test, 7-point self monitored profiles), body weight, insulin glargine doses, to evaluate safety and tolerability (including anti-lixisenatide antibody assessment), and to assess the impact on treatment satisfaction using the Diabetes Treatment Satisfaction Questionnaire (state) (DTSQs) in the participating countries where it is validated.

NCT ID: NCT00975195 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Inhaled Corticosteroid Withdrawal in Patients With Chronic Obstructive Pulmonary Disease

Start date: February 2009
Phase: Phase 4
Study type: Interventional

This is a randomised study to be conducted in patients with severe to very severe Chronic Obstructive Pulmonary Disease (COPD) to establish whether there is a need for these patients to be continuously treated with an inhaled corticosteroid on top of two potent long-acting bronchodilators. The study also aims to identify the type of patients who are likely to benefit from inhaled corticosteroid maintenance therapy.

NCT ID: NCT00975182 Completed - Clinical trials for Non-Squamous Non-Small Cell Lung Cancer, Solid Cancers

A Study of the Safety and Pharmacology of GDC-0941 in Combination With Erlotinib in Patients With Advanced Solid Tumors

Start date: September 2009
Phase: Phase 1
Study type: Interventional

This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics (PK) of oral (PO) GDC-0941 administered in combination with PO erlotinib in patients with advanced solid tumors and patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed at least one prior chemotherapy regimen.

NCT ID: NCT00974909 Completed - Fecal Incontinence Clinical Trials

Percutaneous Tibial Nerve Stimulation in the Treatment of Fecal Incontinence

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

Background of the study: Fecal incontinence is a complex problem. The social consequences of this problem result in a lower quality of life. The exact prevalence of FI is unknown, literature reports vary from 13-19%. There are variable treatment options depending on the patient and the etiology of the FI. Dietary manipulation, pharmacological intervention, pelvic floor physiotherapy, as well as surgical interventions are currently used to treat FI. A promising current treatment is Percutaneous Tibial Nerve Stimulation (PTNS). The nerves in the spine that control bowel function also have branches which go to the ankle. Stimulating these nerves in the ankle has shown to be an effective treatment for FI in the short-term. The treatment has been shown to be safe and well tolerated by subjects with almost no morbidity in prior urology trials. Objective of the study: The objective of this study is to show that the results of PTNS are based on the treatment of electrical stimulation and not on a placebo effect with a sham treatment. Study design: This study is a multicenter, single-blinded, randomized, placebo-controlled trial. Primary study parameters/outcome of the study: The percentage of patients experiencing a ≥ 50% decrease in incontinence episodes from baseline after 9 weeks of treatment. Secondary study parameters/outcome of the study (if applicable): Mean change in the Cleveland Clinic Florida Fecal Incontinence Score (CCF-FI Score) Mean change in Quality of Life scores in validated QoL questionnaires (SF-36, Digestive Health Status Instrument (DHSI), and Fecal Incontinence Quality of life) Subject's and Physician's Global Impression