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NCT ID: NCT01130948 Completed - Healthy Men Clinical Trials

Sleep, Breathing and Psychomotor Performance at Altitude: A Physiologic Study in Healthy Subjects

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

This study investigates the effect of altitude exposure on sleep, breathing and psychomotor performance in healthy subjects.

NCT ID: NCT01130090 Completed - Obesity Clinical Trials

Patient-ventilator Interactions in Long Term Non-invasive Ventilation: Influence of Back-up Frequency

Start date: September 2008
Phase: N/A
Study type: Interventional

In patients under bi-level pressure support ventilation for obesity hypoventilation syndrome, this study aims to determine if it is better, in terms of efficacy and patient-ventilator synchronisation to use - Spontaneous mode (S) - Spontaneous/Timed mode (ST) with an intermediate back-up rate, slightly below the respiratory rate of the patient - Timed mode (T), with a ventilator respiratory rate above that of the patient. This issue has to our knowledge only been marginally studied without any consensus.

NCT ID: NCT01128868 Completed - Clinical trials for Reverse Oblique Subtrochanteric Fractures

Proximal Femur Locking Compression Plates Versus Trochanteric Nails

Start date: May 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the abductor muscle strength measured with a dynamometer in patients with reverse oblique inter- or subtrochanteric fractures treated either with a proximal femur locking plate or a trochanteric nail. "Proximal femur locking plates" stands for both the PF-LCP (Synthes) and the PeriLoc (Smith & Nephew). Trochanteric nails allowed in this study are the Proximal Femoral Nail Antirotation (PFNA), the Titanium Trochanteric Fixation Nail (TFN) and the Gamma Nail (GN).

NCT ID: NCT01128647 Completed - Clinical trials for Carbohydrate Metabolism at Exercise

Disposal of Oral Fructose During Exercise

Start date: April 2009
Phase: N/A
Study type: Observational

There is evidence that total carbohydrate oxidation during exercise is higher after ingestion of fructose:glucose mixture than after ingestion of equimolar amounts of glucose alone. This may possible contribute to improve performance, provided that the extra carbohydrate oxidation induced by fructose:glucose co-ingestion occurs in skeletal muscle. The present study aims at assessing the hypothesis that, during exercise, a substantial portion of oral fructose is converted into lactate prior to oxidation To identify the major pathways of fructose disposal, 7 healthy endurance trained male volunteers will be studied. For each participant the following measurement will be performed - a measurement of maximal oxygen consumption (VO2 max) on an ergometric bicycle - a 2 hour exercise protocol with oral administration of a glucose drink. 6,6-2H2 glucose (0.44 µmol/kg/min) and 13C3 lactate (2.25 µmol/kg/min) will be infused to calculate glucose and lactate kinetics. Indirect calorimetry will be performed to measure total carbohydrate oxidation and expired 13CO2 will be monitored to calculate whole body lactate oxidation - a 2 hour exercise protocol with oral administration of a glucose:fructose (72 + 48 g every hour) mixture. 6,6-2H2 glucose (0.44 µmol/kg/min) and 13C3 lactate (2.25 µmol/kg/min) will be infused to calculate glucose and lactate kinetics. Indirect calorimetry will be performed to measure total carbohydrate oxidation and expired 13CO2 will be monitored to calculate whole body lactate oxidation - a 2 hour exercise protocol with oral administration of a glucose:fructose (72 + 48 g every hour) mixture with fructose labelled with 13C6 fructose to evaluate exogenous fructose metabolic fate and oxidation. 6,6-2H2 glucose (0.44 µmol/kg/min) will be infused to calculate glucose kinetics. Fructose conversion into lactate and glucose will be evaluated by monitoring the systemic appearance of plasma 13C-labelled lactate and 13C-labelled glucose. Total exogenous fructose oxidation will be measured by monitoring 13CO2 production. Based on these measurements, semi-quantitative estimates of total fructose oxidation, fructose conversion into glucose, fructose conversion into lactate, and oxidation of fructose-derived lactate will be obtained

NCT ID: NCT01128335 Completed - Clinical trials for Liver Transplantation

Efficacy, Safety, Tolerability, Pharmacokinetics of Sotrastaurin-tacrolimus vs. Mycophenolic Acid-tacrolimus in de Novo Liver Transplant Patients

Start date: April 2010
Phase: Phase 2
Study type: Interventional

This study will assess the safety and efficacy of different doses of sotrastaurin when combined with tacrolimus for the prevention of acute rejection after de novo liver transplantation.

NCT ID: NCT01127750 Completed - Clinical trials for Relapsing Multiple Sclerosis

Tolerability and Safety and Health Outcomes in Relapsing Multiple Sclerosis (MS) Patients

Start date: May 2010
Phase: Phase 3
Study type: Interventional

This study will assess tolerability and safety and health outcomes in relapsing MS patients taking FTY720.

NCT ID: NCT01127386 Completed - Clinical trials for Cancer Cachexia Syndrome

Lenalidomide for Lean Body Mass and Muscle Strength in Inflammatory Cancer Cachexia Syndrome

Start date: March 2009
Phase: Phase 1/Phase 2
Study type: Interventional

Cancer cachexia syndrome (CCS) is frequent, causing high morbidity and mortality in affected ones. The mechanism is catabolism caused by the tumour. CRP is a surrogate marker for catabolism. There are no effective treatment options against CCS. Lenalidomide, a derivate of thalidomide, is an immunomodulatory drug (IMiD®). One of its' main effect is a decrease in inflammatory cytokines. As CCS treatment, thalidomide has shown in a randomized controlled trial to stabilize lean body mass. The effect of lenalidomide in solid tumour patients was negligible although, there might be a decrease in tumour progression. However, even if lenalidomide may be uninteresting as an anticancer treatment it might affect CCS dynamics. Respective data are currently lacking. Therefore, a dose level where an anticancer effect could be expected was chosen (group A). Relevant anti-inflammatory effect may occur below the commonly used doses to achieve tumour control, which is expected to be the main anti-cachexia effect. Therefore, a second CRP-response guided treatment arm (group B) was chosen. Hypothesis: To test whether the response rate under new standard basic cachexia management will be at the estimated 5% and with lenalidomide (either fixed dose or CRP-guided dose) in addition to basic cachexia management at least 25%. The primary objective of this study is to assess the efficacy of lenalidomide on lean body mass and handgrip strength in advanced solid tumour patients with inflammatory CCS.

NCT ID: NCT01127126 Completed - Overactive Bladder Clinical Trials

Bryophyllum Versus Placebo for Overactive Bladder

Start date: December 2010
Phase: Phase 2
Study type: Interventional

E: The pharmacological effect of Bryophyllum pinnatum could be shown on uterine smooth muscle cells, on spontaneous and oxytocin-stimulated contractions. Smooth muscle relaxation is not only required for preventing premature labour but also for symptom's relief of overactive bladder (OAB). According to previous preclinical and clinical studies, an inhibiting effect of Bryophyllum on OAB is assumed. 20 women are included in this phase 2 drug study, treated with Bryophyllum pinnatum in form of the commercially available Bryophyllum tablets into capsules (verum: 3x2capsules/day) or lactose capsules (placebo: 3x2 capsules/day), 10 women in each group. Duration of the drug administration is 8 weeks. Primary endpoint is the reduction of micturitions per 24 hours (measured by filling in a voiding dairy), secondary endpoints are the improvement of quality of life (measured by using the King's Health Questionnaire and the ICIQ-OAB, two questionnaires, validated for the german language, for women with incontinence), increase of the micturition volumes and reduction of urge episodes (measured by the patients and recorded in a voiding dairy) and the registration of adverse events during the study phase. Ethics committee approval has been given 10th March 2010. - Trial with medicinal product

NCT ID: NCT01126554 Completed - Critically Ill Clinical Trials

ICG- Liver Test Versus New Biomarkers as Prognostic Markers in Critically Ill Patients

Greenpep
Start date: July 2010
Phase: N/A
Study type: Observational

Comparison of ICG liver testing with copeptin and SAPS II score as prognostic markers in critically ill patients.

NCT ID: NCT01126437 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Comparison of Tiotropium in the HandiHaler Versus the Respimat in Chronic Obstructive Pulmonary Disease

Start date: May 2010
Phase: Phase 3
Study type: Interventional

Direct comparison studies of the tiotropium HandiHaler® 18 µg and Respimat® 5 µg formulations have been limited to 4-week crossover studies. Therefore, prospective data from a trial of adequate size and duration is required to establish that compared to tiotropium HandiHaler®, tiotropium Respimat® will have (a) similar effects on safety and (b) similar or superior effects on exacerbations.