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NCT ID: NCT01085071 Completed - Cardiac Surgery Clinical Trials

Comparison of Two Potassium Targets Within the Normal Range in Intensive Care Patients

GRIP-COMPASS
Start date: June 2009
Phase: Phase 4
Study type: Interventional

Rationale: It is well known that distinctly abnormal blood potassium values can cause serious complications such as cardiac arrhythmias. Although potassium regulation is generally considered important, hardly any research has been done about potassium regulation in intensive care patients. The investigators hypothesize that different potassium target-values, within the as normal accepted range, may have different effects in critically ill patients. Study design: A prospective trial comparing two different potassium target-values. Potassium will be tightly regulated with the already fully operational GRIP-II computer program. Study population: 1200 adult patients admitted at the thoracic intensive care unit of the University Medical Center Groningen. Intervention: Comparison between two variations of standard therapy: potassium target-value of 4.0 mmol/L versus 4.5 mmol/L. Main study parameters/endpoints: The primary endpoint is the incidence of atrial fibrillation or atrial flutter from ICU-admission to hospital discharge. Secondary endpoints are serum levels of potassium and the other main electrolytes, renal function and renal potassium excretion, the relation with insulin and glucose, the cumulative fluid balance, (ICU) length of stay and mortality.

NCT ID: NCT01084915 Completed - Weight Loss Clinical Trials

The Results and Outcomes of the Modified Swedish Adjustable Gastric Band (SAGB-VC)

ROS
Start date: March 2010
Phase: N/A
Study type: Observational

Since a few years the SAGB-VC is used in our clinic. This type of band has a number of advantages when compared to the earlier versions of the adjustable gastric band (AGB), reducing the chances on leakage, tube disconnection and port problems. In our clinic the follow up is strict. All patients are required to follow a special follow-up program in which the patient is seen 19 times during the first two years after SAGB-VC placement. This is the first retrospective clinical study of a large study population of >800 patients in which a SAGB-VC was placed. This study was conducted to evaluate the results and the efficiency of the SAGB-VC in our clinic.

NCT ID: NCT01084330 Completed - Clinical trials for Advanced Gastric Cancer

Phase II Trial of AUY922 vs. Comparators in Advanced Gastric Cancer

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

A clinical trial to determine the effectiveness and safety of AUY922 compared to other drugs known to be effective against gastric cancer in second line therapy for patients who have failed one line of chemotherapy.

NCT ID: NCT01084005 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Linagliptin in Elderly Patients With Type 2 Diabetes

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

The objective of the current study is to investigate the efficacy, safety and tolerability of linagliptin (5 mg / once daily) compared to placebo given for 24 weeks as add-on therapy to stable treatment in elderly patients with T2DM with insufficient glycaemic control

NCT ID: NCT01083732 Completed - Clinical trials for Venous Thromboembolism

Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 12 Years of Age

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

To investigate the safety and tolerability of dabigatran etexilate solution in children and to obtain preliminary pharmacokinetic/pharmacodynamic data

NCT ID: NCT01082549 Completed - Clinical trials for Squamous Cell Lung Cancer

Trial of Gemcitabine/Carboplatin With or Without Iniparib (SAR240550) (a PARP1 Inhibitor) in Subjects With Previously Untreated Stage IV Squamous Non-Small-Cell Lung Cancer (NSCLC)

ECLIPSE
Start date: March 2010
Phase: Phase 3
Study type: Interventional

To evaluate the overall survival (OS) of patients with advanced squamous cell lung cancer receiving the combination of gemcitabine/carboplatin either with or without Iniparib. Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.

NCT ID: NCT01082471 Completed - Postoperative Pain Clinical Trials

An Efficacy and Safety Study to Compare Morphine 6-glucuronide (M6G) and Morphine in Patients Suffering With Post-Operative Pain for at Least 24 Hours

Start date: November 2005
Phase: Phase 3
Study type: Interventional

To compare the incidence and severity of nausea in the study treatment groups, during the 18-hour period starting 6 hours after titration to pain relief; following confirmation of the assumption of non-inferiority between the two groups of pain relief over the 24 hour post-operative period. Pain relief and nausea will be determined by measuring the areas under the curves of pain intensity and nausea verbal rating scale scores.

NCT ID: NCT01081678 Completed - Fracture Healing Clinical Trials

Study To Assess FRacTure Healing With SclerosTin Antibody - Hip

STARTT-Hip
Start date: June 20, 2010
Phase: Phase 2
Study type: Interventional

This is an international, multi-center study to determine the efficacy, safety, and tolerability of romosozumab (AMG 785) in adults with a fresh unilateral hip fracture, status post surgical fixation.

NCT ID: NCT01081613 Completed - Breast Cancer Clinical Trials

Imaging HSP90 Inhibitor AUY922 on VEGF-89ZR-bevacizumab Positron Emission Tomography (PET)

Start date: February 2010
Phase: N/A
Study type: Observational

Inhibition of Heat Shock Protein (HSP)90 is a new, promising treatment modality for cancer patients, particularly in the setting of resistance. A reliable read out system (biomarker) for the evaluation of early treatment effect is of great importance in the development of this treatment modality, and could contribute to customize this treatment for individual patients. So far, no reliable biomarker has been described for HSP90 effect. Visualizing the effect of HSP90 on vascular endothelial growth factor (VEGF) secretion in vivo in the patient, by whole body 89Zr-bevacizumab uptake, can be of great importance in this respect, and may contribute to tailored made cancer treatment. The purpose of the present study is to evaluate the effect of HSP90 inhibition by AUY922 on VEGF by means of 89ZR-bevacizumab PET.

NCT ID: NCT01081600 Completed - Breast Cancer Clinical Trials

89Zr-trastuzumab PET for Imaging the Effect of HSP90 Inhibition

AUY922
Start date: February 2010
Phase: N/A
Study type: Observational

HSP90 inhibition is a potentially new targeted drug modality in the treatment of HER2 positive, trastuzumab refractory breast cancer. Little is known about the pharmacodynamics of HSP90 inhibitors in vivo, but non-invasive PET/CT imaging in a xenograft mouse model could visualize and quantify HER2 reduction after AUY922 treatment by 89Zr-trastuzumab PET imaging. Two doses of 50 mg/kg AUY922 resulted in a decrease in HER2 expression of approximately 50%, quantified 6 days after the last administration of AUY922. Visualizing HER2 expression in breast cancer patients before and early following HSP90 inhibition by means of 89Zr-trastuzumab PET, is likely to provide insight in the early in vivo effect of HSP90 inhibition and could potentially support patient tailored therapy.