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NCT ID: NCT01530750 Recruiting - Atrial Fibrillation Clinical Trials

READ-POAF Pilot Studies Postoperative Atrial Fibrillation After Cardiac Surgery

Start date: March 2012
Phase: N/A
Study type: Observational

Postoperative atrial fibrillation after coronary artery bypass grafting will be monitored up to 1 year after the procedure by implanting a Reveal XT internal loop recorder two weeks before the surgery. Frequency, burden, and possible risk factors will be described. During the operation direct contact epicardial mapping will be performed and tissue samples will be collected to identify an electrophysiological and a structural substrate for development of AF.

NCT ID: NCT01530698 Completed - Melanoma Clinical Trials

Single-step Antigen Loading and TLR Activation of Dendritic Cells in Melanoma Patients

Start date: April 2010
Phase: Phase 1/Phase 2
Study type: Interventional

Objectives: This is an exploratory study, consisting of two parts. In part I dose escalation is performed and the primary objective is the safety of different doses of TLR-DC and Trimix DC. In part II Trimix DC vaccination will be compared with TLR-DC vaccination and the primary objective of this part is the immunological response, with toxicity and clinical efficacy being secondary objectives. These studies will provide important data on the safety and immunological effects of TLR-DC and Trimix DC. Study design: Part I of this study is an open label dose escalation study. Part II of this study is an open label randomized phase II study. Study population: Our study population consists of melanoma patients, with proven expression of melanoma associated tumor antigens gp100 and tyrosinase. Melanoma patients with regional lymph node metastasis in whom a radical lymph node dissection is performed within 2 months of inclusion in this study (further referred to as stage III) and melanoma patients with measurable distant metastases (further referred to as stage IV) will be included.

NCT ID: NCT01530308 Completed - Delirium Clinical Trials

Haloperidol Prophylaxis in Older Emergency Department Patients

HARPOON
Start date: November 2012
Phase: Phase 4
Study type: Interventional

The investigators propose a multicenter, randomized, double-blinded, placebo-controlled trial to study the effect of additive low-dose haloperidol prophylaxis on top of exciting care in a general population of older patients (age 70 years and over) acutely admitted to the hospital through the emergency department (ED) for general medicine and surgical specialties, and who are at-risk for developing in-hospital delirium on admission according to the VMS delirium risk questions (one or more positive answers out of three questions). The investigators hypothesize that this intervention will reduce the incidence of in-hospital delirium as well as duration and severity of delirium.

NCT ID: NCT01530139 Completed - Clinical trials for Dietary Modification

Strategies for Personalised Nutrition

Food4Me
Start date: August 2012
Phase: N/A
Study type: Interventional

The concept of personalised nutrition emerged following the sequencing of the human genome in 2000. It was hoped that with the identification of gene nutrient interactions, an individual's response and susceptibility to particular diets would be better understood and therefore appropriate dietary modifications could be made to optimise health and lower disease risk. Then Food4Me aims to study the development of personalized nutrition at three levels and determine whether providing more personalised dietary advice leads to better compliance and health outcomes compared to standard population advice. The hypotheses to be tested in the Food4Me study are as follows: - Personalisation of dietary advice assists and/or motivates consumers to eat a healthier diet and follow a healthier lifestyle (in comparison with "impersonal" [conventional] dietary advice). - Personalisation based on individualised biochemical (phenotypic) and/or genetic information is more effective in assisting and/or motivating study participants to make, and to sustain, appropriate healthy changes to their usual (habitual) diet and lifestyle.

NCT ID: NCT01529632 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Comparison of Safety and Efficacy of the Combination Product QVA149A Against the Concurrent Administration of the Individual Components, QAB149 and NVA237, in Patients With Chronic Obstructive Pulmonary Disease (COPD)

BEACON
Start date: May 2012
Phase: Phase 3
Study type: Interventional

The study assessed the safety and efficacy of the fixed combination product QVA149 versus the component products QAB149 and NVA237, administered concurrently, in patients that have moderate to severe chronic obstructive pulmonary disease (COPD).

NCT ID: NCT01529216 Completed - Clinical trials for Type 2 Diabetes Mellitus

Efficacy Study of the DIAMOND System to Treat Type 2 Diabetes Mellitus

RUBY
Start date: May 2012
Phase: N/A
Study type: Interventional

The study purpose is to demonstrate the benefit of a simplified version of the DIAMOND System (A third Generation) in comparison to a sham treatment in terms of Glycemic control, measured as A1c, FBG and Post-Prandial Glucose levels. The study hypothesis is that HbA1c will show greater improvement in patients receiving 12 months of therapy by the DIAMOMD System than in patients not receiving this therapy.

NCT ID: NCT01528345 Completed - Clinical trials for Metastatic Breast Cancer

Trial Evaluating Dovitinib Combined With Fulvestrant, in Postmenopausal Patients With HER2- and HR+ Breast Cancer

Start date: April 2012
Phase: Phase 2
Study type: Interventional

This trial is designed to enroll postmenopausal patients with locally advanced or metastatic, HER2- and HR+ breast cancer not amenable to curative treatment by surgery or radiotherapy, and whose disease has progressed on or after prior endocrine therapy. Patients must undergo molecular pre-screening prior to entry.

NCT ID: NCT01527929 Completed - Neoplasm Malignant Clinical Trials

Pharmacokinetics and Safety Study of Cabazitaxel in Cancer Patients With Renal Impairment

Start date: April 2012
Phase: Phase 1
Study type: Interventional

Primary Objective: - To assess potential impact of moderate and severe renal impairment on the pharmacokinetics of cabazitaxel Secondary Objective: - To assess the safety of cabazitaxel in patients with various degrees of renal impairment

NCT ID: NCT01527513 Completed - Partial Epilepsy Clinical Trials

Effects of Eslicarbazepine Acetate (Esl, Bia 2-093) on Cognitive Function in Children With Partial Onset Seizures

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

To evaluate the effects of eslicarbazepine acetate on cognition in comparison with placebo as adjunctive therapy in children aged 6 to 16 years old with refractory partial-onset seizures.

NCT ID: NCT01527357 Completed - Clinical trials for Mild or Moderate Surgical Bleeding

A Study of Fibrocaps™ in Surgical Bleeding

FINISH-3
Start date: May 21, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to confirm the superiority of Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, for achieving hemostasis. The investigational products were used in participants with mild to moderate surgical bleeding during spine, liver, vascular or soft tissue surgery, when control of mild to moderate bleeding by standard surgical techniques is ineffective and/or impractical.