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NCT ID: NCT01527318 Completed - Clinical trials for Neutral Lipid Storage Disease

The Effect of Fibrate Therapy in Two Patients With Neutral Lipid Storage Disease With Myopathy (NLSDM)

NLSDM
Start date: August 2011
Phase: Phase 4
Study type: Interventional

Neutral Lipid Storage Disease With Myopath (NLSDM) is a disease caused by a defect in the PNPLA2 gene encoding ATGL. Patients with NLSDM accumulate triglycerides and exhibit muscle weakness, cardiac failure and hepatosteatosis. Most of these patients die at young age due to cardiac failure. Not much is known about the underlying mechanisms, though recently it was discovered that PPAR activation in ATGL-/- mice was impaired leading to decreased mitochondrial function, lipid accumulation and cardiac failure resulting in death at young age. Activation of PPARs, by treatment with fibrates rescued the phenotype and reduced mortality rates in these mice. These findings may have a major impact for patients with NLSDM if these results can be translated to humans. Therefore, the investigators would like to evaluate the beneficial effects of fibrate treatment on muscle mitochondrial and cardiac function in patients with NLSDM. Patients will be treated with fibrates during a period of 28 weeks. Baseline measurements will be performed prior to the study and after treatment. Cardiac and muscular lipid accumulation, cardiac function, mitochondrial function and insulin sensitivity will be assessed during these baseline measurements.

NCT ID: NCT01527266 Recruiting - Clinical trials for Carbohydrate Mouth-rinse on Time Trial Performance

Carbohydrate Mouth-rinse

CHO rinse
Start date: February 2012
Phase: N/A
Study type: Interventional

Several studies have reported that carbohydrate (CHO) ingestion can improve performance during exercise of short duration (less than 60 min). However, there is no apparent metabolic explanation for this observation because endogenous CHO stores should not be a limiting factor during short duration exercise. Nonetheless, several groups have attempted to investigate CHO administration during short duration exercise with varying results. When CHO was administered intravenously, no performance effect was observed despite greater plasma glucose availability (5). Therefore, it was suggested that during exercise of short duration, exogenous CHO ingestion may exert its ergogenic effect by action through the central nervous system, possibly mediated by glucose receptors in the mouth. The latter has been investigated using a CHO-mouth rinse, whereby the CHO solution is spat out to remove any influence of the gut on exogenous CHO oxidation or performance. Using this rinse, studies have demonstrated results both for (5, 16), and against (1, 19) any improvement in short duration exercise performance when compared with a placebo. The discrepancy in the findings may be due to testing subjects in the fed (1) or fasted-state (5), when liver glycogen stores may be compromised. However, no study has tested subjects in both the fasted and fed-state using a CHO-mouth rinse. It remains to be determined whether CHO-mouth rinse is only effective at improving short duration exercise performance when subjects are in the fasted, compared with the fed-state. The investigators will test the hypothesis that CHO-mouth rinse improves performance in the fasted-state only compared with a placebo-rinse.

NCT ID: NCT01526759 Completed - Healthy Clinical Trials

Fiber Longer Term Study on Energy Intake

FLiTS
Start date: December 2011
Phase: N/A
Study type: Interventional

Dietary fibre seems to have a relevant role in body weight management. In an acute study the investigators found that high viscous-high gelling pectin increased feelings of satiety. The objective of this study is to study the effects of 2 weeks of supplementation of high gelling-high viscous fibre or a high gelling-high viscous non-fibre control on energy intake. The investigators do this by measuring the difference in ad libitum energy intake after 15 days of pectin or 15 days of control supplements. The investigators will further measure differences in 24h feelings of satiety, fasting blood glucose and insulin, fermentation and composition of microbiota.

NCT ID: NCT01526083 Completed - Healthy Volunteers Clinical Trials

Effect of Lacosamide 200 mg Twice a Day (Bid) on Single Dose Warfarin 25 mg in Healthy Males

Start date: January 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the effect of Lacosamide 200 mg twice a day (bid) on single dose pharmacokinetics (PK) and pharmacodynamics (PD) of Warfarin (25 mg) in healthy male volunteers.

NCT ID: NCT01526044 Completed - Hypoglycaemia Clinical Trials

Continuous Glucose Monitoring by Subcutaneous Measurement Compared to Frequent Point of Care Measurement by Accu Chek in Critically Ill Patients

RESCUEII
Start date: December 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the accuracy and reliability of the continuous glucose monitoring system the FreeStyle Navigator® (Abbott, Diabetes Care) in critically ill patients by comparing subcutaneous measuring with the current standard of arterial measuring by a point of care glucometer.

NCT ID: NCT01525810 Completed - Hepatitis C Clinical Trials

Three-year Follow-up Study of Subjects Who Participated in a Previous Lambda (BMS-914143) Chronic Hepatitis C Clinical Trial

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

The primary purpose of this study is to determine whether the hepatitis C virus continues to remain unable to be detected in subjects who were previously treated with BMS-914143 and achieved sustained virologic response

NCT ID: NCT01524926 Completed - Clinical trials for Locally Advanced and/or Metastatic Alveolar Soft Part Sarcoma

CREATE: Cross-tumoral Phase 2 With Crizotinib

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

The study will primarily assess the antitumor activity of crizotinib in a variety of tumors with alterations in ALK and/or MET pathways. The targeted patient population will include patients with tumors harboring specific alterations leading to ALK and/or MET activation, where tyrosine kinase inhibitors against these targets have not yet been adequately explored.

NCT ID: NCT01524783 Completed - Clinical trials for Neuroendocrine Tumors

Everolimus Plus Best Supportive Care vs Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced Neuroendocrine Tumors (GI or Lung Origin)

RADIANT-4
Start date: March 30, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the antitumor activity of everolimus plus best supportive care versus placebo plus best supportive care in patients with progressive nonfunctional neuroendocrine tumor (NET) of gastrointestinal (GI) or lung origin without a history of, or current symptoms of carcinoid syndrome.

NCT ID: NCT01524757 Not yet recruiting - Hemochromatosis Clinical Trials

Proton Pump Inhibitors in the Prevention of Iron Reaccumulation in Patient With Hereditary Hemochromatosis

He-ppi
Start date: March 2012
Phase: N/A
Study type: Interventional

Hereditary Hemochromatosis (HH) is a genetic disorder of iron metabolism, resulting in excessive iron overload causing damage of different important organs like heart, liver, pancreas and joints. Complications and symptoms can regress by intensive treatment reducing the iron overload stores.Different genes have been identified playing a role in the pathophysiology of iron overload. A clinically important HFE gene mutation is the C282Y, located on chromosome 6. Phlebotomy is currently the standard therapy which consists of removal of 500 ml whole blood weekly, representing a loss of 250 mg iron. In naive patients between 20 to 100 phlebotomies are required to reduce the serum ferritine levels to 50 μg/L. Thereafter, a lifelong maintenance therapy of 3 to 6 phlebotomies yearly is needed. For absorption, dietary iron ( 70%) is reduced by gastric acid form the ferric (Fe3+) to the ferrous form (Fe2+). Recently, in an observational open study, Hutchinson et al. found that HH patients treated with proton pump inhibitors (PPI) needed fewer phlebotomies, resulting in a drop of 2.5 (SEM 0.25) to 0.5 (SEM 0.25) liter per year. Research question: The primary objective is to determine the effectiveness and cost effectiveness of PPI's compared to standard phlebotomy therapy in the prevention of iron overload in HH patients. Multi-center trial in two hospitals in the South of Limburg (Atrium medical Center, Maastricht university medical center ) and hospital in Belgium (University Hospital Gasthuisberg). The study will be conducted in randomised double blind manner. The follow up will be one year. Patients are randomized either for the group receiving a PPI or a placebo. Every 2 month the ferritin level is measured and decided if the patient need a phlebotomy (Ferritin >100 µg/L).

NCT ID: NCT01524276 Recruiting - Clinical trials for Coronary Artery Disease

Product Surveillance Registry

PSR
Start date: January 2012
Phase:
Study type: Observational

The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.