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Chromosomal instability as indicator for the treatment of progressive mucosal lesions of the oral cavity: a prospective study.

The aim of this prospective study is the prevention of progression of premalignant lesions to invasive head and neck cancer by modifying the out-patient follow up and patient management.

Multi Center Clinical trial of endovascular treatment of acute ischemic stroke in the Netherlands.

The primary objective of this study is to estimate the effect of endovascular treatment on overall functional outcome after acute ischemic stroke of less than six hour duration, in patients with a symptomatic anterior circulation IAO. The secondary…

An Open-Label, Multicenter, Randomized Phase Ib/II Study of Eribulin Mesylate Administered in Combination with Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Alone as First-Line Therapy for Locally Advanced or Metastatic Bladder Cancer

Objectives:Primary* Phase Ib: to determine the maximum tolerated dose (MTD) recommended for Phase II of eribulin mesylate (eribulin), administered in combination with gemcitabine plus cisplatin in patients with locally advanced or metastatic bladder…

(Cost) Effectiveness of Surgery versus Prolonged Conservative Treatment in Patients with Intermittent Neurogenic Claudication caused by Lumbar Stenosis

Intermittent neurogenic claudication due to lumbar stenosis is frequently diagnosed among older persons. Due to an aging population it is to be expected the incidence of lumbar stenosis will increase over time. Patients are operated on because of…

A Phase 2 , Randomized , Single - Blind , Controlled , Comparative Efficacy and Safety Study of Topical Fibrocaps * and Gelatin Sponge in Surgical hemostasis in the Netherlands

1. To characterize the efficacy of topical Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, in surgical subjects when control of mild to moderate bleeding by standard surgical techniques is ineffective and/or impractical2. To…

A Multicenter Prospective Randomized Controlled Clinical Trial to Evaluate the Effectiveness and Safety of the Aperius* PercLID*System Versus Standalone Decompressive Surgery in Degenerative Lumbar Spinal Stenosis with Neurogenic Intermittent Claudication.

The objective of the study is to provide clinical evidence proving that the Aperius* PercLID* System is safe and non-inferior to Standalone Decompressive Surgery (decompressive spinal surgery without additional instrumentation/fixation) with regards…

Prospective study on the treatment of congenital vaginal agenesis or vaginal hypoplasia - genital reconstruction, gynecological and urological aspects, psychosexual and social aspects and quality of life

Evaluation study on the effectiveness of a new developed vaginal dilatation programme for medical-psychological treatment of vaginal hypoplasia / agenesis.

Semi-mechanical versus hand sewn cervical anastomosis after esophagectomy with gastric tube reconstruction for esophageal cancer; the SHARE study

The primary objective of this study is to compare a semi-mechanical with a hand sewn cervical anastomosis after esophagectomy with gastric tube reconstruction for cancer.

Creation of buttonhole cannulation tracks: conventional vs supercath

Compare succesfull creation and usage of the buttonhole track for hemodialyses, created by either the conventional way or with the supercath

A randomized controlled multicenter phase III trial comparing cytoreductive surgery followed by intravenous chemotherapy versus intravenous chemotherapy alone for recurrent platinum-sensitive ovarian cancer

There is still no level I-II evidence for cytoreductive surgery in recurrent ovarian cancer. This is also the conclusion of a Cochrane Review of Galaal et al. published in June 2010. The most active chemotherapy in platinum sensitive recurrent…

Clinical Study of the Valeo OL Interbody Fusion Device for Posterior Lumbar Interbody fusion versus PEEK: the Silicon Nitride and PEEK (SNAP) trial.

Primary ObjectiveThe primary objective is to show that fusion with the Valeo OL spacer produces similar improvement in MRDQ at all follow-up time points as compared to the same procedure with PEEK cages.Secondary ObjectivesTo show that the fusion…

Recurrence rate of hiatal hernia repair with biomesh compared to repair without mesh * a double blinded, randomized, controlled trial.

The above mentioned literature shows that repair of a hiatal hernia using a mesh gives fewer recurrences than repair without mesh. However, there are few prospective randomized controlled trials that provide clear results about this. The most…

Regenerative surgical treatment of peri-implantosseous defects - a multicenter randomized prospective clinical study

Project description:A controlled randomized multicentre prospective clinical trial of 12 months duration at 5 centres. To evaluate and compare appliance of porous titanium granules (PTG) during surgical treatment of peri-implant osseous defects of…

A Multicenter, Prospective, Single-Blind, Randomized, Controlled, Study of the Repair of Challenging Abdominal Wall Defects: Strattice TM in abdominal Wall Repair (StaR)

The primary objective of this clinical study is to compare the incidence of post-repair wound related complications, including hernia occurence/reccurence between challenging abdominal wall defects repaired with Strattice Reconstructive Tissue…

Clinical Application of a Dermal Substitute based on glycerol
preserved Allograft: GLYADERM®
A multicentre, prospective, controlled, randomized, comparative
trial of Glyaderm® and split thickness skin graft versus split
thickness skin graft alone in full thickness skin defects

Objective: The main objective is to evaluate the difference in scar quality, after skin restoration of full thickness defects treated with Glyaderm® and STSG versus STSG alone.Secondary objectives are: to evaluate the percentage of Glyaderm® take…

Uncemented tibial component fixation in total knee replacement using porous titanium.
A Randomised RSA Study

The aim of this study is to compare the early post-operative migration as measured by Roentgen Stereophotogrammetric Analysis (RSA) of the cemented tibial component with the uncemented porous coated tibia component.

postoperative immobilization in arthroscopic rotator cuff repair; the use of botulinum toxin A

Primary objective(s): Is to determine the effect of botulinum toxin injections on postoperative pain and discomfort after an arthroscopic rotator cuff repair.Secondary: To determine whether postoperative immobilization of the rotator cuff, after…

Taste, Speech and oro-facial relations following partial tongue reduction: A single-center, longitudinal, functional outcome study in patients with Beckwith-Wiedemann Syndrome that have undergone tongue reduction surgery

The aim of this study is to investigate the long-term outcomes in patients with BWS that have been surgically treated at our institution with the help of simple, non-invasive, objective study tools. We hope to gain valuable information regarding the…

The role of immunology in diabetes mellitus and pregnancy

Primary Objective: To determine the local and peripheral immune response in diabetic pregnancies in comparison to healthy controls. Immune response will be measured by counting Th1/Th2-cells, Tregs, NK-cells, monocytes and granulocytes. Produced…

Surgical technique for continuous ambulant peritoneal dialysis catheter insertion: Laparoscopic or open catheter insertion?

Primary Objective: Does the use of the laparoscopic insertion technique lower the incidence of malfunctioning CAPD-catheters at 6 weeks postoperatively? Secondary Objectives: Does the use of the laparoscopic insertion technique improve catheter…