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NCT ID: NCT00538356 Completed - Clinical trials for Congestive Heart Failure

Influence of Home Monitoring on the Clinical Status of Heart Failure Patients With an Impaired Left Ventricular Function

IN-TIME
Start date: July 2007
Phase: Phase 4
Study type: Interventional

Re-hospitalizations or deaths by worsening heart failure are often preceded by distinct trends of clinical parameters such as atrial or ventricular arrhythmia, activity, heart rate variability, or ventricular ectopy. The Home Monitoring™ capability offered by BIOTRONIK active implants has the potential to detect some of these trends early and thus to offer the possibility to intervene in time for prevention of fatal worsening of heart failure. To investigate the predictive value of Home Monitoring parameters, patients with symptomatic heart failure and reduced ejection fraction receiving an implantable cardioverter-defibrillator (ICD) or an ICD in combination with cardiac resynchronization therapy (CRT-D) will be randomized between prospective patient management by Home Monitoring analysis or standard care. The influence of Home Monitoring on the clinical status of heart failure patients will be assessed.

NCT ID: NCT00537303 Completed - Clinical trials for Diabetes Mellitus, Type 2

Comparison of the Blood Sugar Lowering Effect and Safety of Two Insulin Treatments in Type 2 Diabetes

Start date: October 2007
Phase: Phase 4
Study type: Interventional

This trial is conducted in Europe, Africa and the United States of America (USA). The aim of this trial is to compare the safety and efficacy of two different insulin treatments, the "basic" and the "advanced" treatment in type 2 diabetes.

NCT ID: NCT00537186 Completed - Clinical trials for Heart Failure, Congestive

A Study of Iron Oligosaccharide in CHF Patients

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

The purpose of this study is to determine the safety profile of iron oligosaccharide in patients with congestive heart failure with a need for parenteral iron.

NCT ID: NCT00537095 Completed - Thyroid Neoplasms Clinical Trials

Efficacy and Safety of Vandetanib (ZD6474) in Patients With Metastatic Papillary or Follicular Thyroid Cancer

Start date: September 28, 2007
Phase: Phase 2
Study type: Interventional

This was a parallel group, randomized, double blind, placebo controlled, multicentre study designed to assess whether vandetanib (ZD6474) conferred an improvement in PFS as compared to placebo in participants with locally advanced or metastatic papillary or follicular thyroid carcinoma failing or unsuitable for radioiodine therapy. The trial was of a sufficient size so that if vandetanib (ZD6474) was truly active there was a high probability that it would demonstrate an effect sufficiently promising to warrant a follow-up assessment. - Participants were seen weekly for the first 2 weeks, then again at Week 4, Week 8, and Week 12 after randomization, and every 12 weeks thereafter. Upon disease progression, all participants (both active and placebo) were unblinded and given the option to discontinue blinded study treatment and enter follow up and survival, or begin open label vandetanib (ZD6474) 300 mg treatment. All participants were followed to collect survival data until greater than or equal to (>=) 50% of participants had died. Participants who were taking vandetanib (ZD6474) at the time of study closure and wished to remain on therapy were allowed to continue for as long as the Investigator felt that they were obtaining clinical benefit, or until they were given another anti-cancer therapy. The safety data from all participants was assessed on an ongoing basis, including discontinuation and follow up. - Radiologic evaluation using RECIST criteria was performed every 12 weeks (+/- 2 weeks). All medical images were centralized assessed at the site and centrally reviewed. Participants were evaluated until progression, and then followed up for survival, regardless of whether they continued randomized treatment, unless they withdrew consent. Post progression open-label vandetanib (ZD6474) were offered at the investigators discretion. - All participants submitted a suitable archived tumor sample prior to randomization. In the event that a suitable archived sample was not available within 2 weeks prior to randomization, a fresh tumor sample was obtained in its place prior to randomization. If a participant underwent the fresh tumor biopsy procedure, this specimen would satisfy the first optional tumor biopsy submission should they consented to the exploratory part of the study.

NCT ID: NCT00536666 Completed - Clinical trials for Chronic Kidney Disease

A Study of Iron Oligosaccharide in Chronic Kidney Disease Patients

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

The purpose of this study is to determine the safety profile of iron oligosaccharide in patients with chronic kidney disease with a need for parenteral iron.

NCT ID: NCT00536029 Completed - Melanoma Clinical Trials

MicroRNA Expression and Function in Cutaneous Malignant Melanoma

Start date: February 2007
Phase: N/A
Study type: Observational

Spectrophotometric intracutaneous analysis (SIAscopy) is a new technique for imaging pigmented skin lesions and for diagnosing melanoma and non-melanoma skin cancer. The SIAscope is a portable system comprising of a laptop computer connected to a small handheld skin probe equipped with a light source. The skin lesion is interrogated with light of different wavelengths and the reflection spectra analysed by proprietary algorithms showing distribution, position and quantity of melanin, blood and collagen within the papillary dermis (the SIAgraphs). Earlier studies generated promising results and documented >80% specificity and sensitivity of SIAscopy for melanoma diagnosis. It has been suggested that this technique could be used for the initial screening and selection of pigmented lesion for excision. In this work we addressed the usefulness of SIAscopy for the clinical diagnosis of pigmented malignant melanoma in a prospective, blinded design.

NCT ID: NCT00535639 Completed - Allergy Clinical Trials

Tolerability of ALK Tree Tablet

Start date: October 2007
Phase: Phase 1
Study type: Interventional

This trial is performed to assess the tolerability of the ALK Tree Tablet in patients with birch pollen induced allergy

NCT ID: NCT00535366 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Efficacy and Safety Comparison of Steroid or Placebo in Combination With Salmeterol and Tiotropium in COPD

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

This efficacy and safety study compares four different combinations of blinded inhaled steroid treatments on top of open-label tiotropium and salmeterol in patients with chronic obstructive pulmonary disease (COPD). The primary objective is the effect on lung function parameters.

NCT ID: NCT00534300 Completed - Clinical trials for Ventricular Tachycardia

Intravenous n-3 Fatty Acids and Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillator (ICD)-Pacemaker

Start date: October 2007
Phase: Phase 1/Phase 2
Study type: Interventional

The long-chain n-3 polyunsaturated fatty acids (PUFA), eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), appear to offer protection against sudden cardiac death and ventricular arrhythmias. EPA and DHA are essential fatty acids which are incorporated into cellular membranes after regular ingestion of fatty fish or fish oil. This study investigates a possible acute effect of intravenous infusion of n-3 PUFA on inducibility of ventricular tachycardia (VT) in patients with an ICD-pacemaker. The hypothesis is that an acute rise in the concentration of n-3 PUFA in plasma will increase the electric stability of the myocardial cells, so that VT is more difficult to induce. In a randomized, placebo-controlled, double-blind, crossover study, a lipid emulsion with a high content of n-3 PUFA (or placebo: isotonic saline) will be administered intravenously before a non-invasive electrophysiologic examination performed via the ICD and following a predefined protocol. The main outcome is inducibility of VT. If sustained VT is induced in a patient after both n-3 PUFA and placebo, the strength of the required stimulus after n-3 PUFA and after placebo is compared.

NCT ID: NCT00532298 Completed - Influenza Clinical Trials

Non-Inferiority of Various GSK Bio's Influenza Vaccine Presentations in Adults Aged 65 Years and Over

Start date: September 20, 2007
Phase: Phase 2
Study type: Interventional

This observer blind study is designed to compare the immune response of GSK Biologicals' influenza vaccine GSK576389A when administered using various presentations in adults aged 65 years and older. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.