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NCT ID: NCT01580293 Completed - Hemophilia A Clinical Trials

A Trial Investigating Safety and Efficacy of Treatment With BAY94-9027 in Severe Hemophilia A

PROTECT-VIII
Start date: April 23, 2012
Phase: Phase 2/Phase 3
Study type: Interventional

Haemophilia A is an inherited disorder in which one of the proteins, Factor VIII, needed to form blood clots is missing or not present in sufficient levels. In a person with haemophilia A, the clotting process is slowed and the person experiences bleeds that can result in serious problems and potential disability. The current standard treatment for severe haemophilia A is regularly scheduled infusion of FVIII to keep levels high enough to prevent bleeding. Due to the short half-life of FVIII, prophylaxis may require treatment as often as every other day. In this trial safety and efficacy of a long-acting recombinant factor VIII molecule is evaluated in subjects with severe Hemophilia A. 120-140 patients will receive open label treatment with long-acting rFVIII either on-demand to treat bleeds or prophylactically for 36 weeks in the main trial plus an optional extension to continue treatment for at least 100 total exposure days (ED). Patients on prophylactic treatment will receive study drug at dosing intervals between once and twice a week depending on their observed bleeding. Patients will attend the treatment centre for routine blood samples and be required to keep an electronic diary. Male patients aged 12-65, with severe hemophilia A, previously treated with FVIII for at least 50 exposure days may be eligible for this study.

NCT ID: NCT01579565 Completed - Clinical trials for Intraocular Lens Replacement

Safety, Efficacy and Pharmacokinetics of OMS302 in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification

OMS302-ILR-004
Start date: April 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the safety, efficacy and pharmacokinetics of OMS302 (the study drug) for maintaining intraoperative mydriasis and preventing post operative pain in individuals undergoing Intraocular Lens Replacement (ILR) surgery.

NCT ID: NCT01578590 Completed - Clinical trials for Skeletal Muscle Hypertrophy

Post-exercise Recovery After Dietary Protein Ingestion in Healthy Young Men (Meat-Milk Study)

Meat-Milk
Start date: May 2012
Phase: N/A
Study type: Interventional

Rationale: The consumption of dietary protein immediately after exercise is necessary to maximally stimulate muscle protein synthesis rates (24, 37). Recent work suggests that the type of protein consumed (e.g., animal vs. plant-derived proteins) during post-exercise recovery can affect the amplitude of acute increases in muscle protein synthesis rates (25, 31). Specifically, consumption of bovine milk proteins immediately after a single bout of resistance exercise stimulates muscle protein synthesis rates greater than consumption of an isonitrogenous soy-protein beverage (31, 37). Importantly, consumption of milk promotes greater hypertrophy than soy after resistance training (10). Thus, it is generally assumed that the acute muscle protein synthetic response predicts long-term training outcomes, such as hypertrophy. Currently, a great amount of work has been carried out to study the effects of consuming milk proteins on muscle protein synthesis rates after resistance exercise (5, 7, 26, 32). However, very little is known about the effects of other types of high-quality animal proteins, such as beef, on stimulating post-exercise muscle protein synthesis rates. Further describing the muscle protein synthetic response after consumption of other types of high-quality animal proteins will provide valuable information for individuals with milk allergies, lactose intolerance, or simply a strong dislike of dairy products. Objective: To investigate whether the in vivo post-resistance exercise muscle protein synthetic response is augmented when minced beef is ingested as compared to an isonitrogenous-matched milk protein beverage in healthy young men. Study design: Crossover, randomized Study population: 12 healthy young males (18-35 y). Intervention: Subjects will perform resistance exercise and consume either a piece of meat (135 grams, 35 g of protein) or an isonitrogenous-matched milk protein beverage on two separate test days. In addition, continuous intravenous tracer infusions will be applied, with plasma and muscle samples collected. A two week 'wash-out' period will be included between trials. Main study parameters/endpoints Primary endpoint: Muscle protein synthetic rate, expressed as fractional synthetic rate (FSR). Secondary endpoints: Rate of protein digestion and absorption and whole body protein balance.

NCT ID: NCT01577212 Terminated - Clinical trials for Stage III Non-small Cell Lung Cancer

Individualized Dose Prescription in Advanced Stage Lung Cancer Patients Using Modern (Chemo)Radiotherapy

IDEAL-VMAT
Start date: March 2012
Phase: Phase 2
Study type: Interventional

The aim of this present study is to test the feasibility and toxicity of individualized hypofractionated radiotherapy, and to report outcome data. In case this phase II trial has favorable results, a phase II/III trial on maximally tolerable, individualized, hypofractionated radiotherapy within a shorter overall-treatment time is aimed for.

NCT ID: NCT01576848 Completed - Sarcopenia Clinical Trials

Impact of Carbohydrate Co-ingestion on the Post-prandial Anabolic Response of Protein in Young and Elderly Men

PRO-CARB
Start date: August 2011
Phase: N/A
Study type: Interventional

Rationale: Age related muscle loss (sarcopenia) is assumed to be related to the impaired postprandial muscle protein synthetic response to protein and/or amino acid administration in the elderly vs the young. Co-ingestion of carbohydrate increases post-prandial insulin secretion. Insulin affects skeletal muscle blood flow and may therefore affect substrate availability and postprandial muscle protein synthesis. However, it is unclear whether the response to the combined intake of protein and carbohydrates is different in elderly compared to young subjects. Hypothesis: Adding carbohydrate to a bolus of protein represents an effective strategy to overcome the impaired postprandial muscle protein synthesis in the elderly. Objective: The primary objective of the study is to investigate whether carbohydrate co-ingestion augments the in vivo postprandial muscle protein synthetic response after protein ingestion and whether this response is different between young and elderly subjects. The secondary objective of the study is to assess the effect of carbohydrate co-ingestion on insulin levels and microvascular perfusion in young and elderly subjects. Intervention: The intervention consists of a single test day during which the subjects will receive a drink containing 20 gram intrinsically labelled casein with or without 60 gram carbohydrates. In addition, continuous intravenous tracer infusions of labeled amino acids will be administered. During the test day 18 plasma samples and 4 muscle biopsies will be collected over a period of 8½ h. Furthermore, muscle skeletal blood flow will be estimated using sidestream darkfield imaging (SDF) in sublingual position.

NCT ID: NCT01576250 Completed - Insulin Sensitivity Clinical Trials

The Effect of Lowered Physical Activity on Insulin Sensitivity and Lipid and Glucose Metabolism

Start date: April 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the effects of lowered physical activity (resulting in decreased muscle mitochondrial oxidative capacity) alone and together with increased plasma free fatty acid availability (by infusion of a clinically widely used lipid emulsion (Intralipid)) on insulin sensitivity and glucose and lipid metabolism. To this end, we will compare skeletal muscle insulin sensitivity and glucose and lipid metabolism (within one subject) after 9 days of immobilization of one leg (unilateral lower limb suspension(ULLS))(decreased muscle mitochondrial oxidative capacity) versus an active control leg (unchanged muscle mitochondrial oxidative capacity). Further, changes in IMCL and fatty acid intermediates will be investigated in the immobilized vs the control leg, and this will be related to insulin sensitivity. The effectiveness of the ULLS intervention will be tested by measuring muscle mitochondrial oxidative capacity in both the immobilized and the control leg. All measurements will be performed both in the immobilized and control leg after 9 days of ULLS.

NCT ID: NCT01576016 Completed - Clinical trials for Adverse Effect of MRI on an Implanted Pacemaker Lead

Safety and Efficacy of the Accent Magnetic Resonance Imaging™ (MRI) Pacemaker and Tendril MRI™ Lead

Start date: March 30, 2012
Phase: N/A
Study type: Interventional

The MRI Study is a prospective, multi-center, clinical study designed to evaluate the safety and efficacy of the Accent MRI™ System in a patient population indicated for implant of a pacemaker within and outside of the MRI environment.

NCT ID: NCT01575873 Completed - Clinical trials for Steroid-induced Osteopor, Glucocorticoid-induced Ostepor

Efficacy and Safety of Denosumab Compared With Risedronate in Individuals Taking Glucocorticoids

GIOP
Start date: March 28, 2012
Phase: Phase 3
Study type: Interventional

This is a 2-year study to evaluate the effect of denosumab versus risedronate in adults with glucocorticoid-induced osteoporosis.

NCT ID: NCT01575782 Terminated - Clinical trials for Small Cell Lung Cancer

Chloroquine as an Anti-autophagic Radiosensitizing Drug in Stage I-III Small Cell Lung Cancer

Chloroquine
Start date: May 2014
Phase: Phase 1
Study type: Interventional

Chloroquine can make tumor cells less resistant to chemo/radiotherapy. In this trial chloroquine is given during radiotherapy. The dose is increased in cohorts of at least 3 patients.

NCT ID: NCT01575392 Completed - Clinical trials for Chronic Kidney Disease

Quality Assessment Creatinines in Plasma and Urine

Start date: June 2010
Phase: N/A
Study type: Observational

In clinical practice the 24-hour creatinine clearance is often used to obtain an impression of renal function. However, the glomerular filtration rate is considered to be the best indicator of renal function. For practical and financial purposes, GFR is often estimated by means of serum creatinine based equations. These equations are also used in internation guidelines to define and classify chronic kidney disease. Therefore, accurate creatinine measurements are important to make reliable estimates of renal function. However, previous research has revealed a large variability in creatinine measurements using different measuring methods. In this study the investigators aim to establish the degree of variability in different methods to measure creatinine in a heterogenous group of Caucasian people with and without renal function loss and the influence of this variability on renal function estimating equations and the 24-hour creatinine clearance.