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NCT ID: NCT01709617 Not yet recruiting - Clinical trials for Carbohydrate Oxidation and Glycogen Utilization During and Following Exercise

Carbohydrate Use During and Following Exercise

CHO-use
Start date: November 2012
Phase: N/A
Study type: Interventional

Carbohydrates are an integral component of sports nutrition. Providing carbohydrate (CHO) during exercise delays the onset of fatigue and improves exercise performance by maintaining high rates of CHO oxidation. Traditionally, glucose, or glucose polymers have been the preferential CHO source found in sports drinks. However, during the intestinal absorption of large amounts of glucose (>1.2 g/min), sodium-dependent glucose transporters (SGLT1) may become fully saturated, potentially limiting the rate of exogenous CHO oxidation. In an effort to evade this limitation, research has suggested using multiple transportable carbohydrates in the composition of sports drinks. Multiple transportable carbohydrates are combinations of simple sugars that use different intestinal transporters during the absorption process. Ingesting multiple transportable carbohydrates may enhance the capacity for total intestinal CHO absorption, leading to an increase in the rate of exogenous CHO oxidation. Our purpose will be to examine the disaccharide sucrose in it's ability to provide exogenous fuel during and following prolonged exercise.

NCT ID: NCT01709500 Completed - Clinical trials for Heterozygous Familial Hypercholesterolemia

Study of Alirocumab (REGN727/SAR236553) in Patients With heFH (Heterozygous Familial Hypercholesterolemia) Who Are Not Adequately Controlled With Their LMT (Lipid-Modifying Therapy)

ODYSSEY FH II
Start date: December 2012
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, parallel-group, multi-national study alirocumab (REGN727/SAR236553) in patients with Heterozygous Familial Hypercholesterolemia (heFH) who are not adequately controlled with their Lipid-Modifying Therapy (LMT).

NCT ID: NCT01709266 Completed - Diarrhea Clinical Trials

The Effect of Probiotics on E. Coli-induced Gastroenteritis

PROTETEC
Start date: August 2012
Phase: N/A
Study type: Interventional

Background: The incidence of gastrointestinal infections is very high. In Western countries at least 30% of the population suffers from at least one food-borne infection per year. Mostly because of the problem of antibiotic resistance, more emphasis is put on prevention of infections. One of the possibilities is to strengthen human resistance to gut infections by consumption of probiotics. A specific blend of probiotic lactic acid bacteria (Lactobacillus helveticus Rosell-52, Lactobacillus rhamnosus Rosell-11, Bifidobacterium longum Rosell-175) and a probiotic yeast (Saccharomyces boulardii), improved stool consistency and shortened the duration of diarrhea in a rat model of E.coli-induced diarrhea. These probiotics showed synergistic effects compared with administration of solely S. boulardii or a mixture of L. helveticus Rosell-52, L. rhamnosus Rosell-11, B. longum Rosell-175. Consumption of S. boulardii and a combination of L. helveticus Rosell-52, L. rhamnosus Rosell-11 reduced diarrhea in humans. Aim: To study whether probiotics improves the resistance of humans to enterotoxigenic E. coli (ETEC). Study design: The PROTETEC study is a parallel, double-blind, placebo-controlled 4-weeks intervention with probiotics in healthy volunteers. In this study, the effect of probiotic intervention vs placebo on several infection markers in response to an ETEC challenge is investigated. Participants will be randomly assigned to the probiotic or placebo group (n=30 per group). Subjects will be instructed to maintain their usual pattern of physical activity and their habitual food intake, but to standardize their dietary calcium intake. After an adaptation period of 2 weeks, subjects will be orally infected with a live, but attenuated, ETEC vaccine (strain E1392-75-2A; collection NIZO food research; dose 10E10 CFU). Before and after infection, a diary will be kept to record all food and drinks consumption (2x2 days) to assess the habitual dietary intake, as well as for daily recording of bowel habits and frequency and severity of gastrointestinal complaints. The following biological samples will be collected: 4x10 ml venous blood, a single fecal bolus (for screening) and 7x24 hrs feces. Blood is sampled for immune response analyses and the fecal samples are collected to quantify several infection- and immune system markers, to determine probiotic excretion, and to verify dietary calcium intake. Study population: Healthy males of 20-55 yrs of age. Interventions: Probiotics (capsules containing freeze-dried powder, probiotic dose per capsule 5x10E9 CFU; twice daily) or placebo (capsules with carrier material powder of identical appearance) Primary outcomes: Fecal ETEC excretion and severity of diarrhea (quantified by fecal output per day). Secondary outcomes: Serum immune response to ETEC, self-reported stool consistency scores and gastrointestinal complaints, relative fecal wet weight. Tertiary outcomes: sIgA and calprotectin in feces, probiotic persistence and levels of opportunistic pathogens in the endogenous microbiota.

NCT ID: NCT01709149 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

Study of Safety, Tolerability & Efficacy of CK-2017357 in Amyotrophic Lateral Sclerosis (ALS)

Start date: October 2012
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to evaluate the safety and effectiveness of CK-2017357 when taken with or without riluzole (also called Rilutek®) in patients with Amyotrophic Lateral Sclerosis (ALS).

NCT ID: NCT01709045 Completed - Stroke Clinical Trials

ParisK: Correlation of Imaging Techniques With Histology

ParisK
Start date: August 2011
Phase:
Study type: Observational

The possibility to identify the risk of rupture of a carotid plaque will have tremendous impact in clinical decision making. A vulnerable plaque is considered to have a large lipid rich necrotic core (LRNC), a thin fibrous cap, the presence of inflammatory cells, intraplaque haemorrhage and/or neovascularisation (vasa vasorum). The investigators aim to validate imaging of plaque vulnerability with histology. Previous studies have evaluated the use of imaging to assess carotid plaque vulnerability, mostly showing a good correlation between imaging and histology and/or clinical characteristics. However, they have focused on single modalities, (magnetic resonance imaging [MRI], multidetector-row computed tomography (MDCT), ultrasonography (US) or transcranial Doppler (TCD), and have used relatively small cohorts The primary goal of this study is to investigate whether there is a correlation between neovascularisation in the carotid atherosclerotic plaque as observed with 3.0 Tesla dynamic contrast-enhanced MRI and histology. Moreover, the investigators aim to investigate the correlation between the volume of the LRNC as determined by dual-energy CT and histology. Secondly, the investigators will investigate the correlation between the volume of the LRNC, the fibrous cap status and the volume of the calcifications determined by MRI versus histology, the correlation between number of microembolisms and fibrous cap status and the correlation between the deformation pattern seen with ultrasound and the volume of the LRNC. The imaging parameters showing good correlation with plaque vulnerability characteristics can be used for further analysis in assessing the vulnerable plaque

NCT ID: NCT01708603 Terminated - Clinical trials for Moderate to Severe Plaque Psoriasis

P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis

AMAGINE-2
Start date: August 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses

NCT ID: NCT01708564 Completed - Hemophilia Clinical Trials

A Phase I Safety, Pharmacokinetics and Pharmacodynamics Study of Recombinant Factor VIIa in Adult Patients With Hemophilia A or B

rhFVIIa
Start date: October 2012
Phase: Phase 1
Study type: Interventional

This study will assess the pharmacokinetics and pharmacodynamics of rhFVIIa at three dose levels. The results will help identify the most optimal doses to take forward to the Phase 2/3 studies where bleedings in hemophilia patients with inhibitors will be treated with rhFVIIa.

NCT ID: NCT01708265 Terminated - Clinical trials for Mitral Valve Insufficiency

The Dutch Asymptomatic Mitral Regurgitation Trial

Dutch AMR
Start date: February 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to compare early mitral valve repair versus a watchful waiting strategy in asymptomatic patients with severe organic mitral valve regurgitation and preserved left ventricular function.

NCT ID: NCT01708174 Completed - Medulloblastoma Clinical Trials

A Phase II Study of Oral LDE225 in Patients With Hedge-Hog (Hh)-Pathway Activated Relapsed Medulloblastoma (MB)

Start date: May 6, 2013
Phase: Phase 2
Study type: Interventional

This Phase II study evaluated the safety and efficacy of LDE225 in adult and pediatric patients with Hh-pathway activated, relapsed MB.

NCT ID: NCT01707628 Completed - Clinical trials for Non-Hodgkin Lymphoma (NHL)

Response to Influenza Vaccination in Lymphoma Patients Treated With Rituximab

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

The purpose of this study is to compare the number of responders to vaccination with the influenza virus vaccine at different time points after last dose of rituximab in patients with lymphoma. Secondly to study the immune-response to vaccination with influenza virus vaccine, after treatment with rituximab in relation to the reconstitution of immune-function.