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NCT ID: NCT01763619 Active, not recruiting - Clinical trials for Symptomatic Cervical Degenerative Disc Disease (DDD) From C3-C7

Freedom® Cervical Disc Use In The Treatment of Cervical Degenerative Disc Disease

Start date: February 2013
Phase: N/A
Study type: Interventional

This study will collect clinical and radiographic data on the Freedom Cervical Disc to monitor the device's safety and performance as part of a post-market evaluation.

NCT ID: NCT01754363 Active, not recruiting - Clinical trials for Noninflammatory Degenerative Joint Disease

Survivorship of Attune Primary Total Knee Prosthesis

Start date: February 1, 2013
Phase: N/A
Study type: Interventional

This post-marketing investigation will evaluate the long term (up to 15 years) survivorship of the Attune Primary Knee Prosthesis in patients with non-inflammatory degenerative joint disease. Data from Subjects who receive one of four knee configurations will be pooled to establish a contemporary dataset.

NCT ID: NCT01742299 Active, not recruiting - GIST and CML Clinical Trials

Study to Allow Access to Imatinib for Patients Who Are on Imatinib Treatment in a Novartis-sponsored Study and Are Benefiting From the Treatment as Judged by the Investigator

Start date: March 26, 2013
Phase: Phase 4
Study type: Interventional

The purpose of this study is to allow continued use of imatinib in patients who are on imatinib treatment in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs (CD&MA) study and are benefiting from the treatment as judged by the investigator.

NCT ID: NCT01738789 Active, not recruiting - Ovarian Tumor Clinical Trials

EURAD-MR Classification : European Multicenter Study

EURAD
Start date: March 2013
Phase: N/A
Study type: Observational

An adnexal mass is the most common indication for gynaecological surgery . Pre operative characterization is crucial and a scoring system would be useful to standardize the imaging report and thus, improve patient management. Recently, our center developed the first MR scoring system named ADNEXMR SCORING system in a retrospective study which is accurate and reproducible (1). Our objectives are to perform an external prospective validation of this scoring system, to evaluate its potential impact on therapeutic strategy and to test its reproducibility. This is a prospective large multicenter study. All patients with a sonographically indeterminate adnexal mass referred for MR imaging will be consecutively included in each center. Then, patients will undergo a routine pelvic MR imaging. Prospectively, one senior and one junior radiologists independently analyze the different MR criteria to characterize adnexal masses. The MR report will be issued as standard and the patient will be managed accordingly. Then, the reader will classify the mass using ADNEXMR SCORING system. The classification will be compared to the reference standard as defined below. The reproducibility of the classification will be tested between the junior and the senior radiologist. After anonymisation, images will be analyzed by another senior radiologist of another center blinded from any clinical or ultrasonographical data and correlated with the reference standard. Reference standard: Reference standard will be surgical procedure with histology or standard clinical follow-up depending on most appropriate routine practice. Sample size: The sample size was computed to ensure a power of at least 90% (with a two-sided type I error rate of 5%) to conclude that SCORE 2 and 3 and SCORE 4 and 5 would have a different PPV. It would thus be necessary to have at least 569 patients classified as SCORE 2, 259 as SCORE 3, 52 as SCORE 4 and 51 as SCORE 5 (18). Given the prevalences, and assuming 6% of patients would be classified, as SCORE 1 and 10% would be lost to follow-up, 1340 patients will be included in this study to insure a probability of at least 95% to obtain the aforementioned number of patients in each score category. The inclusion period will last 18 months (extension for a period of 12 months) and monitoring will continue for 2 years. Thomassin Naggara I., et al. Development and preliminary validation of an MRI Scoring system for Adnexal Masses. Radiology 2013, May;267(2):432-43.

NCT ID: NCT01694654 Active, not recruiting - Clinical trials for Solitary Fibrous Tumors of the Pleura

Epidemiology and Outcome of Solitary Fibrous Tumors of the Pleura.

Start date: September 2012
Phase: Phase 4
Study type: Observational

1. To determine the incidence, prevalence and long-term outcome of patients with SFTP in the German spoken part of Switzerland. 2. To define the role of immunohistochemical and molecular techniques, such as immunostaining, FISH and mutational analysis regarding their ability to predict malignant behavior in terms of prediction of overall survival and disease-free survival.

NCT ID: NCT01672749 Active, not recruiting - Clinical trials for Early Onset Scoliosis

Evaluation of a Modern System to Allow for Growth in Children With Scoliosis Versus a Conventional Treatment

Start date: June 2015
Phase:
Study type: Observational

The foremost challenge when managing early onset scoliosis (curve deformity before the age of 10) is to prevent curve progression while maintaining growth of the spine. Current treatment options require repetitive interventions as the spine and the child grow. This study will compare two techniques of growth modulation: Standard dual growing rods versus the new Luqué Trolley screws Hypothesis: Patients treated with the DePuy Synthes TROLLEY system will undergo fewer re-operations after 3 years of follow-up (FU) than patients included in the comparison group

NCT ID: NCT01661231 Active, not recruiting - Clinical trials for Peripheral Artery Disease

Study to Determine the Performance of the Astron and Pulsar-18 Stents in Europe

BIOFLEX-I EU
Start date: October 2012
Phase: N/A
Study type: Interventional

BIOFLEX-I EU is the European arm of the BIOFLEX-I IDE study (NCT01319812). Data from BIOFLEX-I EU will be pooled with data in the IDE. The objective of this study is to separately demonstrate the clinical performance of BIOTRONIK's Astron and Pulsar-18 stents in the European arm of the BIOFLEX-I IDE (NCT01319812). The Pulsar-18 stent will be used for the treatment of femoro-popliteal lesions, located in the native superficial femoral artery (SFA) or proximal popliteal artery (PPA), while the Astron stent will be used for the treatment of the common or external iliac artery lesions.

NCT ID: NCT01649531 Active, not recruiting - Dental Implants Clinical Trials

Two Implants Versus One Implant With a Cantilever - a Randomized Controlled Clinical Trial

Start date: August 9, 2012
Phase: N/A
Study type: Interventional

The aim of the present study is to test whether there is a difference in the marginal bone level change between implants with and without cantilevers.

NCT ID: NCT01647763 Active, not recruiting - Hemorrhoids Clinical Trials

Hemorrhoidal Artery Ligation and Rectoanal Repair Versus Stapled Hemorrhoidopexy

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

Background: Hemorrhoids of grade 3 and 4 can be treated either by conventional, rather invasive procedures, like Milligan-Morgan or Ferguson or by modern, less invasive procedures with less postoperative pain. Doppler guided hemorrhoidal artery ligation and stapled hemorrhoidopexy are examples for such modern procedures. Hemorrhoidal artery ligation causes less post operative pain than stapled hemorrhoidopexy, however the former has a higher recurrence rate. Combining hemorrhoidal artery ligation with rectoanal repair should reduce the recurrence rate without increasing the post operative pain. Hypothesis and aim: The study tries to prove the assumption that combined hemorrhoidal artery ligation and rectoanal repair cause less pain and have less post operative complications than stapled hemorrhoidopexy.

NCT ID: NCT01623180 Active, not recruiting - Bleeding Clinical Trials

A Randomized Clinical Evaluation of the BioFreedomâ„¢ Stent

Leaders Free
Start date: December 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to demonstrate that a BioFreedomâ„¢ Drug Coated Stent is non-inferior to a bare metal stent at one year as measured by the composite safety endpoint of cardiovascular death, myocardial infarction and definite/probable stent thrombosis, and that its efficacy is superior to a bare metal stent as measured by clinically driven TLR at one year.