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Employing dynamic kinetic responses to demonstrate the effectiveness of dietary intervention: A challenge-based study using a low-glycaemic load diet

Primary objective: To assess the impact of a low glycaemic load (GL) diet as compared to a *Western* diet on metabolic flexibility (the change in RQ) upon a hyperinsulinemic euglycemic clamp. Secondary objectives: 1) To assess the impact of low GL…

Dose-escalation by boosting radiation dose within the primary tumor on the basis of a pre-treatment FDG-PET-CT scan in stage IB, II and III NSCLC: A randomized phase II trial

The primary objective of this study is to determine the freedom from local failure in patients alive at 1 year

A randomized, double-blinded, regimen controlled, phase II, multicenter study to assess the efficacy and safety of two different vismodegib regimens in patients with multiple basal cell carcinomas (BCCs).

The primairy objective of this fase II study, is to compare two treatment regimens of vismodegib in two populations of patients with multiple BCC's (patients with Gorlin syndrome and patients who do not have Gorlin syndrome). Primary to assess…

A Randomized, Open-label, Phase 2 Trial of Ponatinib in Patients with Resistant Chronic Phase Chronic Myeloid Leukemia to Characterize the Efficacy and Safety of a Range of Doses

Primary Objective:To characterize the efficacy of ponatinib administered in 3 starting doses (45 mg, 30 mg, and 15 mg daily) in patients with CP-CML who are resistant to at least 2 TKIs, as measured by MCyR by 12 months.Key Secondary Objectives:* To…

PROMOTION-trial: A PROspective randomized Multicenter trial for the treatment of dislocated 3- and 4-part proximal humerus fractures: Open reduction and internal plate fixaTION versus intramedullary nailing.

Goal of this trial is to point out the surgical intervention with the best functional outcome.

Ulipristal versus Gonadotropin-releasing hormone agonists prior to laparoscopic myomectomy: a double blind randomized controlled trial

Objective: to investigate if Ulipristal is non-inferior to GnRH in terms of intra-operative blood-loss (primary outcome), surgical time, surgical ease, complications, quality of life and costs.

The effect of blood flow restriction with and without resistance exercise on muscle protein synthesis

The main aim of the current study will be to assess the effect of acute blood flow restriction and blood flow restriction combined with resistance exercise on the muscle protein synthetic rate in healthy young male subjects

Mitochondrial Oxygen Tension Improves not upon Fluid Administration but after Transfusion of Erythrocytes (MOTIFATE)
in chronic anemia patients
(a pilot study)

The study will compare the change in cutaneous cellular oxygen availability, measured as mitochondrial PO2 (mitoPO2) between a fluid challenge and a blood transfusion in chronic anemia patients.

RCT to investigate the quality of the of endometrial sample obtained by aspiration when performed before or after the SIS in postmenopausal women.

The primary objective is to investigate the quality (whether assessable by a pathologist or not) of the endometrial sample obtained by aspiration when performed directly before or after the SIS in postmenopausal women. Secondary objectives are to…

An open-label canakinumab (ACZ885) dose reduction or dose interval prolongation efficacy and safety study in patients with Systemic Juvenile Idiopathic Arthritis (SJIA)

Primary:To evaluate if the proportion of patients in clinical remission on canakinumab 4mg/kg (+/- concomitant NSAID only) who are able toremain on a reduced canakinumab dose (2mg/kg every 4 weeks) or prolonged canakinumab dose interval (4mg/kg…

A randomized phase II study for the evaluation of T cell depleted non-myeloablative
allogeneic stem cell transplantation followed by early consolidation with lenalidomide
or lenalidomide combined with bortezomib and subsequent DLI for patients with
multiple myeloma in progression or relapse following first line therapy

Primary objective:Assesment of feasibility and toxicity of T cell depleted NMA Allo-SCT followed by lenalidomide or lenalidomide combined with bortezomib,and subsequent DLI; as treatment of relapsed multiple myeloma.Secondary objectives:To…

ACOSOG Z4099/ RTOG 1021 A randomized phase III study of sublobular resection (+/- brachytherapy) versus stereotactic body radiation therapy in high risk patients with stage I non-small cel lung cancer (NSCLC)

This study is important in that not only will we learn information about the true oncologic differences between these therapies, we will also determine the relative impact of these therapies on pulmonary function and quality of life.

An Extension Protocol for Participants of Genzyme-Sponsored;Prospective, Randomized, Open-Label, Parallel-Group, Multicenter Study of Matrix-Induced Autologous Chondrocyte Implantation (MACI® implant) for the Treatment of Symptomatic Articular Cartilage Defects of the Femoral Condyle Including the Trochlea

The objective of this study is to examine the 5-year efficacy and safety of Matrix-Induced Autologous Chondrocyte Implantation (MACI® Implant), compared with arthroscopic microfracture, in patients who received study treatment in Genzyme-sponsored…

A Multi-centre, Single-blind Trial Evaluating Safety and Efficacy, including Pharmacokinetics, of NNC-0156-0000-0009 when used for Treatment and Prophylaxis of Bleeding Episodes in Patients with Haemophilia B

Primary Objective: To evaluate the immunogenicity of N9-GP.Key Secondary Objectives: * To evaluate clinical efficacy of haemostasis (treatment of bleeding episodes) of N9-GP.* To evaluate clinical efficacy of N9-GP in long term bleeding prophylaxis…

A Randomized, international, multi-center, open-label study to document optimal timing of initiation of dronedarone TreatmEnt after conversion with loading dose of aMIodarone in patients with perSistent Atrial Fibrillation requiring conversion of AF

PrimaryThe primary objective of the study is to evaluate the rate of AF recurrences one month after randomization according to different timings of initiation of dronedaroSecondaryThe secondary efficacy objective is to evaluate the rate of AF…

An Open-Label, Randomized, Multicenter Phase IIa Study;Evaluating Pertuzumab in Combination with Trastuzumab and;Chemotherapy in Patients with HER2-Positive Advanced;Gastric Cancer

Pertuzumab is an investigational agent being studied for the treatment of HER2-positive gastric cancer. This study intends to provide a dose of pertuzumab to find an acceptable minimum pertuzumabconcentratie pertuzumab effective when administered in…

A Single-Center, Open-Label, Parallel Study to Investigate the Effects of Multiple Doses of Ketoconazole on the Pharmacokinetics of a Single Oral Dose of RO4602522 in Healthy Male Subjects.

The purpose of the study is to find out if there is a possible influence of Ketoconazole on the effect of RO4602522 (this is called pharmacodynamics). it will be investigated whether and if so to what extent Ketoconazole influences how fast…

The effect of a high and low protamine-to-heparin dosing on perioperative hemostasis:
a randomized clinical trial

Does a low protamine-to-heparin ratio lead to a reduction in postoperative blood loss and improved postoperative hemostasis when compared to a high protamine-to-heparin ratio in cardiothoracic surgery?

Effects of 8 weeks lower-limb resistance training or lower-limb neuromuscular electrical stimulation (NMES) in severely dyspnoeic patients with chronic obstructive pulmonary disease (COPD) with lower-limb muscle dysfunction: a prospective single-blindrandomized controlled trial.

The purposes of this study are to study the effects of low-frequency NMES, high-frequency NMES and resistance training on health status, exercise tolerance and muscle strength in patients with COPD.

Investigating the role of the Extrastriate Body Area in motor planning - an explorative TMS-study

Here, we want to investigate the role of EBA in planning and control of goal-directed actions using transcranial magnetic stimulation (TMS) and investigate whether EBA plays a crucial role in planning of goal-directed action by providing an early…