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NCT ID: NCT01857024 Completed - Clinical trials for Chronic Kidney Disease

Post Authorisation Safety Study of Renvela® in Chronic Kidney Disease Patients Not on Dialysis With Hyperphosphataemia

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

The primary objective of this study is to assess in a post-approval clinical setting the safety profile of sevelamer carbonate (Renvela®) tablets and powder in adult hyperphosphataemic chronic kidney disease (CKD) patients not on dialysis with serum phosphorus ≥1.78 mmol/L. Patients will be treated in accordance with the Renvela® Summary of Product Characteristics (SmPC) and followed according to the investigator's standard clinical practice management. Each patient will be followed up for 12 months or up to the time they start dialysis, whichever occurs first.

NCT ID: NCT01855750 Completed - Lymphoma Clinical Trials

A Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma

Start date: September 3, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate if ibrutinib administered in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) improves the clinical outcome in newly diagnosed patients with non-germinal center B-cell subtype (GCB) of diffuse large B-cell lymphoma (DLBCL) selected by immunohistochemistry (IHC) or newly diagnosed patients with activated B cell-like (ABC) subtype of DLBCL identified by gene expression profiling (GEP) or both populations.

NCT ID: NCT01854918 Completed - Clinical trials for Hyperlipidemia and Mixed Dyslipidemia

Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia

OSLER-2
Start date: April 23, 2013
Phase: Phase 3
Study type: Interventional

This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia.

NCT ID: NCT01852734 Completed - Uterine Fibroids Clinical Trials

Uterine Fibroid Embolization- Long Term Follow up and Technical Perspectives

Start date: November 2013
Phase: N/A
Study type: Interventional

The purpose of this prospective non-randomised study is to examine whether two different microspheres (Bead-Block and Embosphere) are equally effective in the treatment of the uterine fibroid controlled with contrast-enhanced MR examination. Quantitative MR imaging, including dominant fibroid T1, T2 and contrast enhancement characteristics before intervention and 3 months after interventions will be analysed as a potential predictor of volumetric response after embolization. Another purpose is to determine long-term follow-up in all patient treated in a period from 2001-2011 in OUH analysed retrospectively.

NCT ID: NCT01851889 Completed - Heart Failure. Clinical Trials

Optimizing Continuous-flow Left Ventricular Assist Device Settings and Identification of Pump Malfunction - A Comparative Study of Echocardiography and Invasive Hemodynamics

Start date: April 2013
Phase: N/A
Study type: Observational

The purpose of the trial is to identify factors which can be used as guidance when optimizing continuous-flow left ventricular assist device (CF-LVAD) settings. The hypothesis of the study is that pulmonary capillary wedge pressure (PCWP) will change independently of left ventricular end diastolic diameter (LVEDD) when increasing pump speed ie ΔPCWP/RPM ≠ ΔLVEDD/RPM. The primary combined endpoint of the study is correlation between ΔPCWP and LVEDD slope under ramp testing in a cohort of "continuous-flow left ventricular assist device" heart failure patients.

NCT ID: NCT01851499 Completed - Spinal Cord Injury Clinical Trials

Ultramicronized PEA (Normast) in Spinal Cord Injury Neuropathic Pain

Start date: May 2013
Phase: N/A
Study type: Interventional

Randomized, double-blinded, placebo-controlled, parallel group study of ultramicronized PEA (Normast)600 mg x 2 daily or corresponding placebo with a week of baseline period followed by 1 x 12 weeks treatment period.

NCT ID: NCT01849718 Completed - Clinical trials for Stress-related Problem

Nacadia Effect Study (NEST)

NEST
Start date: August 2013
Phase:
Study type: Observational

This research project deals with stress treatment in the form of garden therapy in the therapy garden Nacadia. The therapy Garden Nacadia has an evidence-based design that is specially designed for the treatment of stressed people. Nacadia-therapy can be described as a process in which the patient's health and well-being is assumed to enhance by the presence of the natural environment and through participating in meaningful gardening activities. NEST concerns research on the effect of Nacadia-therapy. The study consists of randomized and longitudinal studies of the effects of Nacadia-therapy compared to acknowledged cognitive behavioral therapy (CBT). The outcome measures for example consist of: ability to return to work, health care use, psychological measurements related to stress, health, quality of life and changes in medication use. Further, exploratory studies of the garden therapy in the form of observations and interviews will be performed, to get a better understanding of the garden and the garden activities' importance for the therapeutic purposes. Hypothesis: - garden therapy, in a designed natural environment, will lead to improved health and well-being for people who are off sick with stress-related disorders

NCT ID: NCT01849705 Completed - Obesity Clinical Trials

Melanocortin 4 Receptor Mutations and Obesity-associated Diseases

Mc4Obes
Start date: October 2012
Phase: N/A
Study type: Observational

Mutations in the melanocortin 4 receptor (MC4R) are the most common form of monogenic obesity, and can explain 2-6% of severe obesity. Studies have shown that mutations in MC4R are associated with increased fat mass, height-for-age, appetite and insulin resistance among children. In adults, mutations in MC4R are less penetrant for these phenotypes but it has been observed that individuals with MC4R mutations have a smaller than expected blood pressure for their degree of obesity. The purpose of this study is to explore the association between functional MC4R mutations and obesity, insulin resistance and blood pressure.

NCT ID: NCT01848886 Completed - Clinical trials for Coronary Artery Disease

Neurological Complications Comparing Endoscopically vs. Open Harvest of the Radial Artery

NEO
Start date: May 2013
Phase: N/A
Study type: Interventional

Coronary artery bypass grafting (CABG) using the radial artery (RA) has since the nineties gone through a revival. The initially reported worse outcome in RA graft patients compared to patients grafted with the saphenous vein (SV) has since been corrected. Studies have shown better patency when using RA, so the RA is going to be preferred more and more especially in younger patients where long time patency is critical. During the last 10 years endoscopic techniques to harvest the RA have evolved. Multiple different techniques have been used, but now the equipment and technique have been refined and are highly reliable. The investigators hypothesize that the endoscopic technique has less complications and a just as good patency as open harvest. There are also two possible ways to use the RA as a graft. One way is sewing it onto the aorta and another way is sewing it onto the mammarian artery. The investigators hypothesize that using it on the mammarian artery is superior as a revascularisation technique with just as good a patency as sewing it directly onto the aorta.

NCT ID: NCT01848769 Completed - Asthma Clinical Trials

Clinical Pharmacology Study of CHF1535 pMDI 50/6 µg Versus The Free Combination In Asthmatic Children 5-11 Years Old

PAED1
Start date: September 2009
Phase: Phase 2
Study type: Interventional

The rationale is to investigate the systemic availability of BDP/B17MP and formoterol after single oral inhalation of CHF 1535 50/6 pMDI vs the free combination of approved BDP and Formoterol pMDIs, in asthmatic children (5 to 11 years old).