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NCT ID: NCT01729455 Active, not recruiting - Clinical trials for Systemic Lupus Erythematosus

Safety and Effectiveness of BENLYSTA (Belimumab) in Systemic Lupus Erythematosus (SLE) Registry

SABLE
Start date: February 21, 2013
Phase:
Study type: Observational [Patient Registry]

The purpose of this prospective, observational cohort study is to evaluate the incidence of adverse events of special interest (AESI) and effectiveness in participants with active, autoantibody-positive SLE treated with and without BENLYSTA (belimumab). Participants will be enrolled into 1 of 2 cohorts: (1) BENLYSTA cohort: participants receiving or initiating BENLYSTA plus standard of care (SOC) at Baseline; (2) comparison cohort: participants not receiving BENLYSTA but receiving SOC at Baseline. After enrollment, changes in lupus medications, including starting or stopping BENLYSTA, are at the discretion of the physician, and all participants will continue to be followed regardless of changes in their lupus medicines until study completion. All participants will be assessed for AESI including serious infections, opportunistic infections and other infections of interest, malignancies, selected serious psychiatric events and mortality. Data will be collected at enrollment and at 6 month intervals for 5 years. BENLYSTA is a registered trademark of GlaxoSmithKline (GSK) group of companies.

NCT ID: NCT01701479 Active, not recruiting - Neuroblastoma Clinical Trials

Long Term Continuous Infusion ch14.18/CHO Plus s.c. Aldesleukin (IL-2)

LTI
Start date: January 2012
Phase: Phase 1/Phase 2
Study type: Interventional

The main aim of this clinical trial is to find a way of giving ch14.18/CHO, in combination with subcutaneous aldesleukin (IL-2) and oral isotretinoin (13-cis-RA), to children and young people with primary refractory or relapsed neuroblastoma without intravenous morphine.

NCT ID: NCT01700543 Active, not recruiting - Clinical trials for Rheumatoid Arthritis

Sidus(TM) Post Market Clinical Follow-up (PMCF) Study

Start date: October 2012
Phase:
Study type: Observational

This post market clinical follow-up study is designed to confirm safety and performance of the Sidus Stem-Free Shoulder when used in hemi or total shoulder arthroplasty. The safety of the implant will be evaluated by monitoring the frequency and incidence of all kinds of adverse events. The performance will be determined by analyzing the implant survival, overall pain and functional performances (based on Constant & Murley score and ASES score), subject quality of life (EuroQol EQ5D) and radiographic parameters (e.g. radiolucencies, osteolysis, component migration) of study subjects who received the Sidus Stem-Free Shoulder. The Sidus Stem-Free Shoulder is not approved for use in the US.

NCT ID: NCT01698671 Active, not recruiting - Clinical trials for Aortic Aneurysm, Abdominal

InterGard Synergy Post-Marketing Surveillance Study

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

The purpose of the study is to assess the performance and safety of the InterGard Synergy vascular graft.

NCT ID: NCT01680562 Active, not recruiting - Clinical trials for Non-melanocytic Skin Tumors

In-vivo Optical Coherence Tomography Imaging in Dermatooncology

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

In vivo differentiation of benign and malignant skin lesions is a fundamental issue in clinical dermatology. Malignant skin diseases are known to be accompanied by structural alterations. Conventional excisional biopsies and further histopathology are regarded as the reference standard for investigating these pathologies. Biopsies are invasive procedures and additionally may cause side effects. Therefore, research efforts are focused on the development of diagnostic techniques capable of providing in vivo information on the skin's structure. Optical coherence tomography (OCT) is a technical application, which allows the identification of microscopic patterns indicative for benign and malignant skin lesions. OCT is a promising noninvasive imaging technique for the micromorphology of the skin. So far, it's clinical application, as an additional diagnostic tool for malignant skin lesions has been studied in a limited extend. To evaluate the clinical usefulness of OCT, we conducted a prospective pilot study at the Department of Dermatology, Medical University of Vienna. The study is in cooperation with the Center of Biomedical Engineering and Physics at the Medical University of Vienna. A total of 70 malignant skin lesions was evaluated during this prospective pilot study. Diagnoses based on OCT imaging as an additional diagnostic tool, were compared to those based on the clinical standard pathway at the Department of Dermatology, Medical University of Vienna. For the purpose of this study, the histopathological diagnosis was used as the reference diagnostic standard. The major aims of this study is the investigation of the ability of ultrahigh resolution OCT to identify fine morphological characteristics associated with basal cell carcinoma, actinic keratosis, superficial squamous cell carcinoma, seborrheic keratosis, melanocytic nevi and melanoma. - To correlate the morphologic features identified with ultrahigh resolution OCT with routine histopathology - To investigate the clinical feasibility of ultrahigh resolution and spectroscopic OCT technology - To assess the effectiveness of ultrahigh resolution and spectroscopic OCT imaging to diagnose various melanocytic and non-melanocytic skin tumors - To compare the diagnostic capabilities of ultrahigh resolution OCT with standard non-invasive diagnostic procedures such as epiluminescence microscopy

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: NCT01658930 Active, not recruiting - Cervical Cancer Clinical Trials

Radical Versus Simple Hysterectomy and Pelvic Node Dissection With Low-risk Early Stage Cervical Cancer

SHAPE
Start date: December 10, 2012
Phase: N/A
Study type: Interventional

The reason this study is being done is to see if a simple hysterectomy is as good as a radical hysterectomy in preventing cancer of the cervix from returning, and whether, because less tissue surrounding the uterus is removed during surgery, there are fewer side-effects after the surgery and in the long-term.

NCT ID: NCT01635452 Active, not recruiting - Uterine Fibroids Clinical Trials

A Prospective Multicenter Non-interventional Study of Women Treated With ESMYA (Ulipristal Acetate) as Pre-operative Treatment of Moderate to Severe Symptoms of Uterine Fibroids

PREMYA
Start date: May 2012
Phase: N/A
Study type: Observational

This is a multi-center, prospective, non-interventional study of patients who have been diagnosed with moderate to severe symptoms of uterine fibroids and are initiating a pre-operative treatment with ESMYA. The objectives of the study are to characterize and describe treatment with ESMYA and to evaluate the safety, effectiveness, and HRQL outcomes in this population

NCT ID: NCT01634204 Active, not recruiting - Overweight Clinical Trials

Efficacy of a Web-based Weight Loss Program

Start date: September 2011
Phase: Phase 2
Study type: Interventional

Since overweight and obesity, a risk factor for various diseases, is a prevalent problem in the modern society, it is important to search for new strategies to counteract this. In contrast to in person support, the internet provides a low cost opportunity, which is able to reach a large part of the population. Therefore a web-based weight loss program may be an adequate mean for many people. Now it is hypothesised that a web-based weight loss program is able to support a reduction of body weight and weight-related cardiovascular risk factors effectively and to promote a healthier lifestyle. It is expected that program use, compared to a control group, results in greater reductions in body weight and cardiovascular risk.

NCT ID: NCT01594723 Active, not recruiting - Clinical trials for Neoplasms, Hematologic

A Study of LY2784544 in Participants With Myeloproliferative Neoplasms

Start date: May 22, 2012
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is to measure the response rate in participants with the myeloproliferative neoplasms (MPNs), polycythemia vera (PV), essential thrombocythemia (ET), or myelofibrosis (MF) when treated with LY2784544, including those who have demonstrated an intolerance to, failure of primary response to, or have demonstrated disease progression while on ruxolitinib.