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Acute Nutritional Ketosis in VLCAD Deficiency: testing the metabolic basis for therapeutic use

To test if acute NK boosts muscle mitochondrial function in vivo in patients with VLCADD in order to establish a rational basis for therapeutic use in this disorder. A secondary objective is to gather data to test the working hypothesis that the…

Group rehabilitation for renal patients

The purpose of GRN-study is: 1. to determine the long-term effectiveness of a 12 weeks lasting physical exercise training program. 2. to determine the costeffectiveness of the 12 weeks lasting physical exercise training program. In aim of the GRN-…

A Study to Evaluate the Efficacy and Safety of GFT505 once daily on Steatohepatitis in Patients with Non-Alcoholic Steatohepatitis (NASH).
A Multicentre, Randomized, Double Blind, Placebo-Controlled study, with an adaptive design to allow for initial GFT505 80mg dosing versus placebo, followed by a second phase including GFT505 120mg dose, after review of 6-month safety analysis of the 80mg data on at least 50% of patients.

The primary objectives of this study are: - To evaluate the efficacy of GFT505 80mg and GFT505 120mg once daily (according to adaptive design, after 6-month interim safety analysis of the 80mg data on at least 50% of patients) for 52 weeks versus…

A Randomized, Controlled, Open-label, Multicenter, Phase IIb
Safety and Efficacy Study of HGT-1410 (Recombinant Human
Heparan N Sulfatase) Administration via an Intrathecal Drug
Delivery Device in Pediatric Patients with Early Stage
Mucopolysaccharidosis Type IIIA Disease

The primary objective of this study is to assess the potential clinical efficacy of HGT-1410administered via a surgically implanted IDDD in patients with MPS IIIA. Efficacy will bemeasured as a meaningful amelioration in the progression of cognitive…

A Double-blind, Randomized, Multicenter Study to Evaluate Safety and Efficacy of AMG 145, Compared With Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor (AMG 145 20110116)

Primary: To evaluate the effect of 12 weeks of subcutaneous (SC) AMG 145 every-2-weeks (Q2W) and every-4-weeks (Q4W), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C).Secondary objectives:…

A Double-blind, Randomized, Placebo and Ezetimibe Controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Combination With Statin Therapy in Subjects With Primary Hypercholesterolemia and Mixed Dyslipidemia (AMG 145 20110115)

Primary: To evaluate the effect of 12 weeks of subcutaneous (SC) AMG 145 every-2-weeks (Q2W) and every-4-weeks (Q4W), compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C).Secondary objectives: Safety…

Energy expenditure and sleep in response to protein/carbohydrate and fat ratio

To determine energy expenditure and sleep in response to protein/carbohydrate and fat ratio of the diet over a short-term and long-term period of time.

Impact of microbial communities on obesity

The aim of this study is to test the hypothesis that obesity and the microbial community in the human GI tract are linked

Effect of prebiotic fibres on Intestinal Health and Functioning

To study effects of AXOS (1) on gut health including among other parameters intestinal transit time, fecal cytotoxicity, pH, inflammatory markers, short-chain fatty acids and microbiota composition), gut permeability and gut functioning (bloating,…

Effect of Fecal microbiotA Transplantation combined with MEditerranean Diet on insulin sensitivity in subjects with metabolic syndrome

To study the effect of a Mediterranean diet (MD) followed by lean donor fecal microbiota transplantation (FMT) versus the prescription of Mediterranean diet (MD) followed by autologous (own) FMT in male subjects with metabolic syndrome on peripheral…

A phase 1, randomized, double-blind, placebo-controlled, single-site study to assess the safety, tolerability, pharmacokinetics and food effect of MIN-102 following oral administration of single and multiple ascending doses in healthy male volunteers

The purpose of the study is to investigate to what extent MIN-102 is tolerated.It will also be investigated how quickly and to what extent MIN-102 is absorbed and eliminated from the body (this is called pharmacokinetics). In addition, the effect of…

Non-invasive rapid assessment of non-alcoholic fatty liver
disease (NAFLD) using Magnetic Resonance Imaging with LiverMultiScan (RADIcAL)

Primary objective: To investigate whether the introduction of LiverMultiScan as a standardised diagnostic test for liver disease can prove a cost effective method in different EU territories.Secondary Objectives:- To investigate patient satisfaction…

SeMaglutide and Albuminuria Reduction Trial in obese individuals without diabetes

The main objective of the study is to assess the albuminuria lowering effects of semaglutide 2.4 mg s.c. once weekly (Semaglutide 3 mg/ml) compared to placebo in obese/overweight non-diabetic individuals with elevated albuminuria.

Physical Exercise Prehabilitation Program in mEtabolic suRgery

The aim of this study is to investigate whether prehabilitation could enhance preoperative physical condition and weight loss before bariatric surgery and induce a lifestyle behavior change.

A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When Evolocumab (AMG 145) is Used in Combination With Statin Therapy In Patients with Clinically Evident Cardiovascular Disease

Primary Objective: To evaluate the effect of treatment with AMG 145, compared with placebo, on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs…

Safety, tolerability, pharmacokinetics and pharmacodynamics of single rising subcutaneous doses of BI 3006337 in healthy male subjects (single-blind, partially randomised within dose groups, placebo-controlled, parallel (sequential) group design)

In this study we investigate how safe the new drug BI 3006337 is and how well it is tolerated when used in healthy subjects.We also investigate how quickly and to what extent BI 3006337 is absorbed, transported and excreted by the body. We also look…

Simvastatin addition to improve symptoms, cognition, metabolic syndrome and movement disorders in patients with recent-onset psychotic disorder.

The primary objective of this trial is to investigate the proposed beneficial effect of simvastatin on total symptom severity (PANSS) ascompared to placebo when given in addition to antipsychotic medication, and the effects on neurocognitive…

Long-term effects of a potato-based food pattern vs a rice / pasta-based food pattern on fasting & postprandial cardiometabolic health; The LoPoCardio - trial

The objective is to evaluate the effects of longer-term consumption of diets rich in boiled potatoes versus those rich in rice or pasta on established cardiovascular risk parameters.

The effects of FRUctose restrIcTion on LivEr SteatosiS; the FRUITLESS study

To quantify the change in hepatic fat (primary objective) and endothelial function, arterial stiffness, plasma lipids, plasma biomarkers of inflammation and endothelial function, and plasma advanced glycation end products (secondary objectives)…