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NCT ID: NCT02078908 Completed - Healthy Clinical Trials

The Effect of Sodium Nitrite on Renal Function and Blood Pressure in Healthy Humans. A Dose-response Study

Start date: September 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the effect of different doses of sodium nitrite infusion in 12 healthy subjects. The effects on renal handling of nitrite, nitrate, sodium and water, plasma concentrations of vasoactive hormones, peripheral (brachial) and central blood pressure will be evaluated. Hypothesis Sodium nitrite infusion 1. increases urinary sodium excretion and renal filtration rate 2. lowers blood pressure, central as well as peripheral 3. affects vasoactive hormones 4. it is possible to establish a dose that affects the renal function with only minor effect on the blood pressure.

NCT ID: NCT02078687 Completed - Allergy Clinical Trials

Growth, Risks of Allergy and Metabolic Syndrome in 6 Year Old Children Born Preterm Compared to Postdischarge Nutrition

Start date: October 2010
Phase: N/A
Study type: Interventional

This is a follow-up cohort study of 6 years old children born preterm in Denmark from 2004-2008, and at four different neonatal units. During hospitalisation they received breast milk with fortification. At time of discharge there were made 3 different nutrition groups; if possible they were randomised into one of two groups: 1. Breastfeeding solely 2. Breastfeeding with fortification If breastfeeding was not possible they were put in group 3 and were bottle fed with: 3. Preterm formula This nutrition intervention went on for 4 month. At the age of 6, the children will be invited to come for an ambulant control and other examinations regarding growth, allergy and metabolic syndrome.

NCT ID: NCT02078466 Completed - Geriatric Disorder Clinical Trials

Assessment of Functional Ability and Follow-up at Home for Older Medical Patients

Start date: March 2014
Phase: N/A
Study type: Interventional

The aim of this study is to examine the effect of an intervention that consist of assessment of functional ability, rehabilitation plan and follow-up at home for older medical patients. The hypothesis is that assessment of functional ability, development of rehabilitation plan and follow-up at home reduce the older medical patient's risk of readmission. Also the intervention is expected to reduce mortality, number of contacts to general practitioners and emergency physician

NCT ID: NCT02078427 Completed - Hemophilia A Clinical Trials

ADVATE/ ADYNOVI Hemophilia A Outcome Database (AHEAD)

AHEAD
Start date: June 28, 2011
Phase:
Study type: Observational

The purpose of the study is to document the natural history of hemophilia A disease and long-term outcomes in terms of effectiveness, safety and quality of life in participants receiving Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM) or Antihemophilic Factor (Recombinant) - Pegylated (rAHF-PEG) in routine clinical practice

NCT ID: NCT02077764 Completed - Clinical trials for Heart Transplant Recipients

The GRAFT Study: Evaluation of Graft Function, Rejection and Cardiac Allograft Vasculopathy in First Heart Transplant Recipients.

Start date: September 2013
Phase: N/A
Study type: Observational [Patient Registry]

Objective: - To assess the relationship between coronary allograft vasculopathy (CAV) and graft function, and to evaluate non-invasive methods for CAV diagnosis. - To assess left ventricular (LV) and right ventricular (RV) function in the acute phase and serially during the first year after transplantation. - To evaluate the impact of acute and repetitive rejection on the longitudinal myocardial function Hypothesis 1. Timing of development and degree of CAV can be measured non-invasively combining myocardial longitudinal deformation (by advanced echocardiography) and coronary flow velocity reserve (CFVR) (by echocardiography and PET). This combination of methods can detect CAV before it is angiographically visual and gives supplementary information of the impact on myocardial graft function. 2. Longitudinal deformation, 3D echocardiography, cardiac magnetic resonance imaging (CMRI) and PET can be used for RV and LV myocardial function assessment and represent more valid markers of the function than standard echocardiography in heart transplant (HTX) patients. 3. Myocardial longitudinal deformation is a better marker of acute rejections than conventional ejection fraction (EF). Background The most frequent heart related death causes after HTX are CAV, acute graft failure and rejection. CAV is characterized by diffuse concentric intima thickening involving both epicardial vessels and the coronary microvascular system. In our clinical approach HTX-patients are followed with annual CAG and standard echocardiography with estimation of LV systolic function by EF. Standard echocardiography has not proven benefit in the diagnosis of CAV. CAG often misses CAV in early phases. In various cardiac diseases it is well known that ischemia and fibrosis often affect the endocardial longitudinal oriented layers. Longitudinal deformation by advanced echocardiography has shown to be better markers for systolic function in HTX patients compared to standard EF. Longitudinal LV systolic function is dependent of endocardial perfusion. CFVR represents the capacity of the coronary circulation to dilate due to metabolic demands and has been shown to correlate with longitudinal deformation in myocardial infarction. CFVR measurements in HTX patients with advanced echocardiography and PET scan have shown a significant correlation to CAV. RV failure is an early, potentially fatal, complication to HTX. The function and change over time of RV have not been fully studied using modern echocardiographic techniques or assessment by CMRI. Acute rejection is an inflammatory response often diagnosed by routine biopsies (gold standard). These are expensive, time consuming and inconvenient for the patient. The role of conventional echocardiography has not yet found a significant role in the diagnostics of acute rejections and furthermore how repeated rejections influence on graft function is not well described. Study 1 A cross sectional study consisting of 50 stabile HTX patients. These will be selected with 25 patients with no or light CAV and 25 patients with moderate or severe CAV. Severity of CAV will be evaluated by: - CAG - CFVR measurement by advanced echocardiography and PET. Graft function will be evaluated by: - Advanced echocardiography at rest end during bicycle exercise. - CMRI including assessment of LV and RV EF, strain and mass. - During rest and bicycle exercise echocardiography simultaneously right heart catheterization are performed for hemodynamic measurement Study 2 A prospective cohort study with 20-25 newly transplanted patients over a period of 12 months. LV and RV function will be measured by: - Advanced echocardiography - CFVR measurement (echocardiography and PET) - CMRI for LV and RV EF, strain and mass - Right heart catheterization Study 3 Prospective examination of correlation between graft function, CAV and rejection. Information of former episodes of acute rejection is collected retrospective. Study objectives are all living HTX patients (approx. 200) in the period of 2011-2013. Advanced echocardiography (including longitudinal deformation), biopsies (rejection evaluation) and CAG (CAV evaluation).

NCT ID: NCT02077673 Completed - Surgery Clinical Trials

Gastric Microperfusion in Patients Undergoing Gastroesophageal Resections

Start date: December 2013
Phase: N/A
Study type: Observational [Patient Registry]

Gastroesophageal resection because of gastroesophageal junction (GEJ) adenocarcinoma is a massive surgical intervention. Currently, gastroesophageal cancer surgery is performed with upper laparotomy followed by thoracotomy at the Department of Surgical Gastroenterology, Rigshospitalet, Denmark. However, minimal invasive techniques (MIT), e.g. robotic assisted laparoscopy, is in the progress of being implemented in this field as they are hypothesized to be more beneficial for the patients, and in some aspects better than conventional laparoscopic surgery. The operative procedure is often complicated by low blood pressure (systolic blood pressure less than 90 mm Hg is experienced in more than 30 % of the patients) and is probably accompanied by a reduced splanchnic microcirculatory flow, leading to increased morbidity. Hypotension may be due to several factors, among them are epidural analgesia, mesentery traction reflex, and inflammatory and vasoactive hormones. Aim of the project The aim of the project is, through a series of sub-projects, to validate or invalidate the relationship between changes in the microcirculatory blood flow in the stomach and the systemic hemodynamic changes. Furthermore, the aim is to assess the changes in the microcirculatory blood flow as a consequence of the thoracic epidural anesthesia. In addition, the aim is to assess the hypothesis that the mesenteric traction reflex and changes in the PGI2 levels may influence systemic hemodynamic changes, and that robotic assisted MIT will attenuate the mesenteric traction reflex and changes in PGI2 compared to open surgery.

NCT ID: NCT02077491 Completed - Clinical trials for Systemic Inflammatory Response Syndrome

The Effect of Protein and Resistance Training on Muscle Mass in Acutely Ill Old Medical Patients

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

The purpose of this study is to determine the effect of a high-protein diet during hospitalization in combination with resistance training and a daily protein and energy supplement three months after discharge on the muscle mass, muscle strength, functional ability and weight in acutely ill old medical patients.

NCT ID: NCT02077348 Completed - Clinical trials for Diabetes Mellitus Type I

Metabolic Signalling in Muscle- and Adipose-tissue Following Insulin Withdrawal and Growth Hormone Injection.

Start date: May 2014
Phase: N/A
Study type: Interventional

Diabetes mellitus type I (DM I) is characterized by lack of endogenous insulin and these patients are 100% dependent on insulin substitution to survive. Insulin is a potent anabolic hormone with its primary targets in the liver, the skeletal muscle-tissue and - adipose-tissue. Severe lack of insulin leads to elevated blood glucose levels, dehydration, electrolyte derangement, ketosis and thus eventually ketoacidosis. Insulin signalling pathways are well-known. Growth hormone (GH) is also a potent anabolic hormone, responsible for human growth and preservation of protein during fasting. GH (in concert with lack of insulin) induces lipolysis during fasting. It is not known how GH exerts its lipolytic actions. The aim is to define insulin and growth hormone (GH) signalling pathways in 3 different states in patients with DM I. And to test whether ATGL-related lipolysis in adipose tissue contributes to the development of ketosis. 1. Good glycemic control 2. Lack of insulin (ketosis/ketoacidosis) 3. Good glycemic control and GH injection

NCT ID: NCT02077192 Completed - Clinical trials for Immune Thrombocytopenic Purpura

Open Label Study of R788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)

Start date: October 2014
Phase: Phase 3
Study type: Interventional

The primary objective of this study was to assess the long term safety of fostamatinib in subjects with persistent/chronic ITP

NCT ID: NCT02077114 Completed - Clinical trials for Malignant Melanoma With Metastasis

Vaccination With Peptides in Combination With Either Ipilimumab or Vemurafenib for the Treatment of Unresectable Stage III or IV Malignant Melanoma

Start date: February 2014
Phase: Phase 1
Study type: Interventional

The purpose of the study is to assess whether a vaccine containing a small fragment of the protein IDO, which may be present in cancer cells and cells of the immune system, is safe to use in combination with either Ipilimumab or Vemurafenib in the treatment of malignant melanoma that has metastasized.