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NCT ID: NCT01730001 Withdrawn - Trauma Clinical Trials

Early Versus Late Intubation Trial in Physician Manned Emergency Medical Services

ELITE
Start date: January 1, 2015
Phase: N/A
Study type: Interventional

This study looks at advanced airway management in critically ill or injured patients treated by physician manned emergency medical services, comparing early (on-scene) intubation to late (emergency department) intubation.

NCT ID: NCT01729013 Completed - Obesity Clinical Trials

Duration of Vitamin D Stores After Prolonged Vitamin D Substitution

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

Ingested or skin produced vitamin D is either hydroxylated in the liver to 25-hydroxyvitamin D (25(OH)D), metabolized and excreted in the urine, or stored in adipose and other tissues. The capacity for vitamin D storage in adipose tissue is not known, nor the importance of such storage which may potentially be of vital importance when intake or solar exposure is limited. In the present study we will include 76 subjects who have participated in an intervention study with vitamin D (20.000 IU per week) versus placebo for the prevention of type 2 diabetes, and who have completed the study after 5 years or who have been excluded because of diagnosed type 2 diabetes or for other reasons. If vitamin D is stored to any extent in the body the subjects given 20.000 IU vitamin D per week for 2-5 years will have a considerable amount of stored vitamin D and accordingly, a slow decline in serum 25(OH)D during the following year without vitamin D substitution, which will be measured in the present study. If our hypothesis is correct, that vitamin D can be stored in significant amounts when the supply is abundant; current advice on vitamin D supplementation mainly during winter should be changed to "year around" in order to build up sufficient stores for the months without sufficient sun light.

NCT ID: NCT01728987 Withdrawn - Obesity Clinical Trials

The Significance of Vitamin D Storage in Adipose Tissue

Start date: August 2016
Phase: Phase 2
Study type: Interventional

The study will examine the role of adipose tissue in vitamin D physiology, particularly its role as a depot. the study is randomized double blind and placebo controlled.

NCT ID: NCT01728415 Recruiting - Clinical trials for Chronic Renal Disease

Effects of High-intensity Interval Training in Patients in Hemodialysis

OsloExDia
Start date: October 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effects of high intensity interval training compared to moderate exercise training and a control group on exercise capacity and quality of life in patients with end stage renal disease on hemodialysis.

NCT ID: NCT01728155 Completed - Clinical trials for LOW AND INTERMEDIATE PAEDIATRIC NEUROBLASTOMA AND NEONATAL SUPRARENAL MASSES

European Low and Intermediate Risk Neuroblastoma Protocol

Start date: January 1, 2011
Phase: Phase 3
Study type: Interventional

The European study, LINES 2009 (Low and Intermediate Risk Neuroblastoma European Study), groups together in a single protocol the treatment of all patients with "non high risk" neuroblastoma (NB), with stratification into two groups: low risk and intermediate risk. These two separate cohorts are included in one single protocol to enable patient data from these two groups to be entered into a common database, as the current prognostic classifications determining treatment may evolve further with subsequent more detailed molecular analysis of the tumours. 1. LOW RISK STUDY The Low Risk Study is proposed in order to: - minimise the amount of treatment (chemotherapy and surgery) for all appropriate low risk patients, who in previous studies have been shown to have an excellent long-term outcome (as in the SIOPEN 99.1-2 infant neuroblastoma studies where the overall survival was greater than 97%(H. Rubie, JCO). - improve the EFS and maintain the OS (overall survival) in L2 and Ms patients with a SCA(Segmental Cromosomal Aberration) genomic profile tumour (presence of any segmental chromosomal change (SCA)) by electively treating these patients with chemotherapy despite the absence of symptoms. 2) INTERMEDIATE RISK STUDY The Intermediate Risk Study is proposed in order to: - reduce the amount of chemotherapy for differentiating histology INRG (International Neuroblastoma Risk Group) stage L2 NB and ganglioneuroblastoma nodular patients who in previous SIOPEN study have been shown to have an excellent long-term outcome; - increase the amount of treatment (radiotherapy and 13-cis-RA (13-cis-Retinoic Acid) for poorly differentiated or undifferentiated histology INRG stage L2 NB or ganglioneuroblastoma nodular patients in order to improve the EFS registered in the previous SIOPEN study; - improve the EFS (Event Free Survival) of MYCN (V-Myc myelocytomatosis viral related oncogene, NB derived ,avian )amplified INSS (International NB Staging System) stage 1 NB patients with the introduction of adjuvant treatment; - maintain the very good results obtained in previous SIOPEN study for INRG stage M infants with a moderate treatment. NEONATAL SUPRARENAL MASSES The incidence of suprarenal tumours/masses has increased in the last decade due to the expanded use of prenatal ultrasonography in routine obstetric care and in the neonatal and early infancy care. The differential diagnosis of these masses ranges from benign (adrenal haemorrhage) to malignant processes (neuroblastoma, adrenal carcinoma). Knowledge on perinatal suprarenal masses, although based on a relatively large literature, is scattered amongst studies on very few cases with no methodical approach and often short follow up. Therefore, the optimal management of these masses has not been clearly defined. Neuroblastoma at this age is an intriguing entity with a very good prognosis in most cases. The SIOPEN Group, based on their results in the first multicenter European Trial for infants with neuroblastoma (INES) and the world-wide experience provided in the literature, is launching this European surveillance study (Multi-centre, non-blinded, one armed prospective trial) for these masses. Treatment: Observation

NCT ID: NCT01728012 Completed - Renal Transplant Clinical Trials

Long-term Cardiovascular Risk Following Successful Renal Transplantation

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

Mineral metabolism disturbances occur early during the course of chronic kidney disease and eventually affect most patients. For how long such disturbances persist after a successful renal transplantation is mainly unknown. This study will investigate the prevalence of such disturbances in patients more than 10 years following a successful renal transplantation. The patients will be recruited from an existing registry in Norway.

NCT ID: NCT01725724 Completed - Coxarthrosis Clinical Trials

Effects of the Sangvia Blood Collection System on Postoperative Infections in Orthopedic Patients

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

The purpose of this study is to compare the infection rate in patients receiving/not receiving their own blood, collected during surgery, during and after orthopedic surgery. The hypothesis is that transfusion of autologous salvaged blood may reduce postoperative infection.

NCT ID: NCT01725204 Completed - Clinical trials for Leukemia, Myeloid, Chronic-Phase

Safety and Efficacy of Pegylated IFN-alpha 2B Added to Dasatinib in Newly Diagnosed Chronic Phase Myeloid Leukemia

NordCML007
Start date: September 2012
Phase: Phase 2
Study type: Interventional

Patients with newly diagnosed CML have excellent outcomes with tyrosine kinase inhibitors (TKI). However, a few patients will be cured with TKIs alone, and thus need continued life-long treatment. Some patients achieve complete molecular remission (CMR), and this rate is higher with second generation TKIs compared with imatinib. Some experience with drug discontinuation in CMR has been derived from a few small studies, most notably the French STIM study. Approximately 40 % of patients with a minimum of two years in MR4.5 (4.5 log reduction in molecular response) can stop imatinib without relapse, indicating possible cure. To increase the non-relapse rate is of major importance. To achieve a permanent "cure" without stem cell transplantation is presently the most relevant goal of clinical studies in CML. The investigators hypothesize that to significantly increase cure rates in CML, therapy should eradicate leukemic stem cells and/or induce or restore anti-CML immunity. Second generation TKIs may have a more profound effect on the stem cell pool as compared to imatinib. This is assessed in our current randomized study with a reduction in leukemic stem cell burden as the primary endpoint (NordCML006). Interferon-alpha (IFN) has a prominent immunomodulatory and antiproliferative mode of action, and has also activity in stem cells. Pegylated IFN in combination with imatinib results in improved therapy responses as compared to imatinib monotherapy. This advantage may translate into higher cure rates. Dasatinib has a unique dual mechanism of action: it is the most potent of available TKIs and induces immunological effects that are different from those of IFN. Both of these drugs may have immunological adverse-effects when used as a monotherapy. However, immunological adverse-effects may also be markers of anti-leukemia efficacy. A combination of dasatinib and pegylated IFN (PegIFN) may have additive or synergistic effects and should be tested in a clinical study.

NCT ID: NCT01724333 Completed - Cancer Clinical Trials

International Validation of the QLQ-OH17 for Oral Health

QLQ-OH17
Start date: December 2012
Phase:
Study type: Observational

Assessment of oral and dental problems is seldom routine in clinical oncology, despite the potential negative impact of these problems on nutritional status, social function and quality of life (QoL). A brief, assessment tool for oral/dental health and related QoL-issues to improve symptom management has been requested. The present study will be conducted on behalf of and with support from the European Organisation for Research and Treatment of Cancer - (EORTC) Quality of Life Group (QLG). The study represents phase IV, the final step, in the development of an international, symptom specific questionnaire module, focusing on oral and dental problems in relation to cancer and its treatment. Phase I-III of this stepwise development process was conducted from 2008 to 2011, as an international collaboration and conducted according to the guidelines for module development set forth by the EORTC QLG. The resulting module, the QLQ-OH17, is now subject to an international field testing and validation study as described in this project description. The present version of the QLQ-OH17 consists of 17 items conceptualized into four multi-item scales (pain/discomfort, xerostomia, eating and information) and three single items related to use of dentures and future worries. The aim of the present study is to conduct phase IV; an international field study to confirm the psychometric properties of the QLQ-OH17

NCT ID: NCT01721928 Completed - Acute Kidney Injury Clinical Trials

Norwegian Intensive Care Unit Dalteparin Effect Study

NORIDES
Start date: December 3, 2012
Phase: N/A
Study type: Observational

The main purpose of the NORIDES study is to investigate the effect of pharmacological thromboprophylaxis with low molecular weight heparins (LMWHs) in critically ill patients, and how it is affected by presence of acute kidney injury (AKI) and treatment with hemodialysis. The main objective is to compare the prophylactic effect of dalteparin in intensive care unit (ICU) patients with AKI and Citrate-Calcium dialysis (CiCa-dialysis) with a control group of ICU patients with normal kidney function. Our main hypothesis is that CiCa-dialysis reduces dalteparin effect, and that patients undergoing CiCa-dialysis do not achieve adequate prophylaxis against venous thromboembolism (VTE). The primary endpoint is development of DVT during ICU stay, the secondary endpoint inadequate heparin effect measured in blood samples.