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NCT ID: NCT02560519 Completed - Clinical trials for C.Surgical Procedure; Cardiac

Albumin in Cardiac Surgery

ALBICS
Start date: March 21, 2017
Phase: Phase 4
Study type: Interventional

Colloid solutions are widely used for volume replacement therapy because of their high oncotic pressure, which could reduce interstitial fluid shifting. Human albumin is the only colloid solution of biologic origin with a molecular weight of 60 kDa. As the most abundant plasma protein, it has physiological importance in the well-being of the endothelial glycocalyx. Older studies in septic patients, however, did not show any benefit of albumin over saline solution. Crystalloid solutions, such as Ringer's acetate, do not impair neither renal function nor coagulation, but their volume expanding effect is questionable. For several reasons (use of heart-lung machine, systemic inflammation, coagulation disturbances), patients undergoing cardiac surgery need especially large amounts of fluids. However, there are no large trials comparing albumin solutions to crystalloid solutions cardiac surgery. This double-blinded trial will randomize according to a power analysis 1250 cardiac surgery patients (=625+625) at Meilahti hospital to use either 4% Albumin or Ringer's acetate solutions for both priming of the heart-lung machine and perioperative volume replacement therapy. The primary efficacy and safety endpoint of this study is the incidence of major adverse events (MAE), defined as a composite endpoint of all-cause mortality, acute myocardial infarction, acute heart failure or low output syndrome, resternotomy, stroke, certain arrhythmias, major bleeding, infections compromising post-procedural rehabilitation, acute kidney injury within 90 days postoperatively. The secondary outcomes are total number of MAEs, major adverse cardiac events (MACE), perioperative fluid balance, blood product transfusions, blood loss, acute kidney injury, days alive without mechanical ventilation/outside ICU/at home in 90 days as well as 90-day mortality. Blood samples for biochemical analyses will be collected at four perioperative time points. This trial will provide data about efficacy and safety of 4% albumin in cardiac surgery patients. The biochemical mechanisms of albumin will be assessed.

NCT ID: NCT02560480 Completed - Groin Injury Clinical Trials

Groin Injuries in Finnish Contact Sports

Finngroin
Start date: August 2015
Phase:
Study type: Observational

The prevalence of acute and chronic groin injuries in athletes is between 5 and 10 %. This observational case-control study follows three contact sport teams (soccer, ice-hockey and bandy) for two years to find out the prevalence and reasons for groin pain. Clinical examination, pain scores and pelvic magnetic resonance imaging (MRI) are performed. Hip and groin questionnaire (HAGOS) is used to determine severity of groin injuries.

NCT ID: NCT02558530 Completed - NAFLD Clinical Trials

Resolution of Liver Fat in Non-alcoholic Fatty Liver Disease

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

The major adverse health consequences of obesity occur only when non-alcoholic fatty liver disease (NAFLD) also develops. NAFLD is characterized by abnormal hepatic accumulation of triglycerides and other lipids. The first-line approach to NAFLD management is caloric restriction and weight loss, but these remain difficult to achieve. Little attention has been given to dietary carbohydrate restriction, despite recent reports showing that hepatic de novo lipogenesis, a process that converts dietary carbohydrates into fatty acids in the postprandial state, accounts for approximately 25% of liver triglyceride content in hyperinsulinemic subjects with NAFLD. For comparison, only 15% of the liver triglycerides were derived from dietary fatty acids in patients with NAFLD who had consumed a standardized 30% fat diet for four days before being assessed.

NCT ID: NCT02555683 Completed - Asthma Clinical Trials

Study of Efficacy and Safety of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.

Start date: December 11, 2015
Phase: Phase 3
Study type: Interventional

This study aimed to determine the efficacy and safety of QAW039 150 mg and QAW039 450 mg, compared with placebo, when added to GINA (Global Initiative for Asthma) steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA 2016) in the following two populations: - patient with inadequately controlled severe asthma and high eosinophil counts at baseline (eosinophil count at Visit 1 ≥250 cells/ µl) (sub-population) - patients with inadequately controlled severe asthma (overall study population) Inadequate control is defined as partly controlled or uncontrolled asthma (GINA 2016).

NCT ID: NCT02554734 Completed - Parkinson's Disease Clinical Trials

Pharmacokinetic Study in Healthy Volunteers

NOCOFPK2
Start date: August 2015
Phase: Phase 1
Study type: Interventional

Phase I open, randomized cross-over pharmacokinetic study.

NCT ID: NCT02554162 Completed - Clinical trials for Subjective Appetite and Satiety

Chewy Satiety - the Interplay Between Food Structure, Oral Processing and Satiety

Start date: October 2015
Phase: N/A
Study type: Interventional

This study examines if there are differences in satiety responses between structurally different wholegrain rye products.

NCT ID: NCT02548884 Completed - Clinical trials for Endoscopic Retrograde Cholangiopancreatography

Pancreatic Sphincterotomy Versus Double Wire Technique in Difficult Cannulation

Start date: September 2015
Phase: N/A
Study type: Interventional

The purpose of the study is to compare two different techniques (pancreatic sphincterotomy (PS) and double wire technique (DGW)) regarding the risk of post-ERCP pancreatitis (PEP) and the success of cannulation in difficult cannulation. For the study, the difficult cannulation is de-fined as situation when the common bile duct has not been cannulated in five minutes, after five attempts or after two pancreatic guide wire passages or when any of those limits is exceeded. The two techniques, the PS and the DGW, will be compared in random fashion. The primary end-point is the risk of PEP .

NCT ID: NCT02547337 Completed - Type 1 Diabetes Clinical Trials

Glucose-stimulated Pancreatic Islet and Intestinal Blood Flow in Healthy Subjects and in Type 1 Diabetes

ISLET-PET
Start date: September 10, 2015
Phase:
Study type: Observational

Type 1 diabetes is the major type of diabetes in the young. The pathophysiology still needs clarification in order to reach feasible means of preventing the disease. This study aims in defining the differences in pancreatic and intestinal blood flow between subjects with and without type 1 diabetes and validating the methodology to achieve this. Earlier animal studies have demonstrated changes in pancreatic islet blood flow using microspheres. The aim of this study is to test and validate a method for the assessment of islet perfusion in humans using molecular imaging. The investigators hypothesize that glucose-stimulated pancreatic perfusion is enhanced specifically in islets in healthy subjects and that this increase is mostly suppressed in subjects with type 1 diabetes. Positron emission tomography (PET) is a non-invasive imaging technique, which can be used to study flow and metabolism of different organs. Using radiowater ([15O]H2O) and PET, cellular perfusion can be measured directly and noninvasively. Recently, diffusion weighted magnetic resonance imaging (DWI) has also been applied as a complimentary method for the assessment to quantitate changes in pancreatic blood flow. In the study 10 healthy subjects and 10 subjects with type 1 diabetes will be imaged on two separate days. Pancreatic and intestinal perfusion are first measured with [15O]H2O and combined PET/magnetic resonance imaging before and 5 and 15 minutes after intravenous glucose infusion. On the second day, PET imaging is replaced by dynamic DWI conducted in the same time schedule and with intravenous glucose stimulation.

NCT ID: NCT02545257 Completed - Polypharmacy Clinical Trials

Development of a Coordinated, Community-Based Medication Management Model for Home-Dwelling Aged in Primary Care

Start date: September 2015
Phase: N/A
Study type: Interventional

The objective of this randomized controlled trial is to develop a coordinated, multiprofessional medication management model for home-dwelling aged in primary care and to study the effectiveness of this model. The main hypothesis is that the new model helps to identify aged people having potential risks with their medications and thus allows solving these risks.

NCT ID: NCT02545049 Completed - Clinical trials for Diabetic Kidney Disease

Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease

FIGARO-DKD
Start date: September 17, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo.