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NCT ID: NCT01109771 Completed - Ventral Hernia Clinical Trials

Absorbable Versus Permanent Mesh Fixation Trial in Laparoscopic Midline Ventral Hernia Repair

SORBET
Start date: April 2010
Phase: Phase 4
Study type: Interventional

To compare the use of absorbable tackers versus permanent tack fixation using a polyester large pore mesh in laparoscopic midline ventral hernia repair in a multicenter (Belgian) prospective randomized single-blinded trial. All patients referred for elective midline ventral hernia repair should be assessed for eligibility and entered in a study log, detailing all included patients during the study period.

NCT ID: NCT01109680 Completed - Clinical trials for Metabolism of Neramexane

A Single Center, Open-Label Study to Quantify Metabolites of [14C]-Neramexane in Plasma and Urine in Healthy Male Subjects

Start date: April 2010
Phase: Phase 1
Study type: Interventional

A Single Center, Open-Label Study to quantify metabolites of [14C]-Neramexane in plasma and urine in Healthy Male Subjects

NCT ID: NCT01109160 Completed - Clinical trials for Lymphocytic Bronchi(Oli)Tis Post-lung Transplantation

Study of Azithromycin for Lymphocytic Bronchiolitis/Bronchitis After Lung Transplantation

AZI002
Start date: April 2010
Phase: Phase 4
Study type: Interventional

This study investigates the role of azithromycin treatment for lymphocytic bronchitis/bronchiolitis after lung transplantation.

NCT ID: NCT01108861 Completed - Clinical trials for Peripheral Vascular Disease

GORE VIABAHN® Versus Plain Old Balloon Angioplasty (POBA) for Superficial Femoral Artery (SFA) In-Stent Restenosis

RELINE
Start date: May 2010
Phase: Phase 4
Study type: Interventional

This is a prospective, randomized, multi-center study recruiting patients with an in-stent restenosis in the superficial femoral artery. The safety and efficacity of the Viabahn endoprosthesis (W.L. Gore & Associates), a heparin-bonded endoprosthesis, is compared with plain old balloon angioplasty (POBA). In 4 Belgian and 2 German centers a total of 80 Patients will be recruited. Primary endpoint is primary patency at 12 months, defined as no evidence of restenosis or occlusion within the originally treated lesion based on color-flow duplex ultrasound (CFDU) measuring a peak systolic velocity ratio ≤2.5, and without target lesion revascularization (TLR) within 12 months. In comparison to POBA, it is expected that the use of the Viabahn endoprosthesis (W.L. Gore & Associates) will result in greater 12 month primary patency of treated superficial femoral artery in-stent restenotic lesions.

NCT ID: NCT01108510 Completed - HIV Infections Clinical Trials

Safety and Efficacy of COBI-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults

Start date: April 2010
Phase: Phase 3
Study type: Interventional

This study is designed to evaluate the safety and efficacy of a regimen containing Cobicistat (COBI)-boosted atazanavir (ATV/co) plus emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus ritonavir (RTV)-boosted atazanavir (ATV/r) plus FTC/TDF in HIV-1-infected, antiretroviral treatment-naive adults. Development of COBI as a "pharmacoenhancer" could provide a beneficial alternative to RTV for use in combination with protease inhibitors.

NCT ID: NCT01108341 Completed - Clinical trials for Non-Hodgkin's Lymphoma (NHL)

Study to Evaluate the Efficacy and Safety of Treatment With Bendamustine in Combination With Ofatumumab in Previously Untreated Patients With Indolent B-Cell Non-Hodgkin's Lymphoma (NHL)

Start date: May 2010
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to determine the efficacy, as measured by overall response (complete response + partial response) of bendamustine in combination with ofatumumab in previously untreated patients with indolent B-Cell Non-Hodgkin's Lymphoma (NHL).

NCT ID: NCT01107821 Completed - Wounds Clinical Trials

Negative Pressure Wound Therapy With the Engenex™-Pump and Bio-Dome™ Dressing, an Evaluation

Start date: February 2010
Phase: Phase 4
Study type: Interventional

Negative pressure wound therapy (NPWT) has become a powerful tool in wound bed preparation of complex wounds and is routinely used in various disciplines, including general surgery and plastic surgery. NPWT involves the creation of a controlled subatmospheric pressure in the wound bed. The vacuum is generated by a pump and is distributed over the wound bed by a dressing (mostly a foam or gauze sponge). The therapy has several positive effects on the wound bed, such as improved local blood circulation, stimulation of granulation tissue formation and controlled evacuation of wound exudates. Standard negative pressure applied mostly varies between -120 mmHg and -130 mmHg.A new way of applying NPWT is the Engenex™ system using the Bio-Dome™ Wound Dressing, a specially engineered structure that forms a defined space above the surface of the wound. This space will maintain its size and integrity in the presence of negative pressure and wound fluids and thus effectively imposes strain on the underlying tissue. The material properties of the dressing permit moist wound healing while encouraging efficient removal of exudates. The contact material will not absorb fluid. It has been clinically shown that the Bio-Dome™ Wound Dressing is effective at growing granular tissue in the base of a wound at a safe low negative pressure of -75 mmHg, possibly reducing dressing ingrowth into the wound bed to a minimum. Our intention is to evaluate NPWT by means of the Engenex™ pump and Bio- Dome™ Wound Dressing in 15 patients. Patients with large soft tissue defects will be examined by a plastic surgeon and if suitable for NPWT they will be treated with the Engenex™ NPWT system. Before starting NPWT wounds will be evaluated and measured (length, width, depth, volume) if possible. Digital photos will be made and wound swabs will be taken for microbiological examination.Dressing changes will be performed twice weekly, on Monday and Thursday or on Tuesday and Friday. At each dressing change a wound will be re-evaluated and measured. Other parameters to be noted will be, amongst others: pain, comfort, ease of use,material used, time needed for dressing change, etc. The NPWT treatment will be carried on for maximum three weeks. During this period plastic surgeons will evaluate whether the wound is ready for surgical closure or not. If surgical closure after 3 weeks is not yet an option possibility exists that NPWT will be continued. Every wound will be followed up until complete wound healing after surgical closure. All patients data will be recorded, secured, evaluated and analysed for both medical parameters and health economic parameters.

NCT ID: NCT01107444 Completed - Clinical trials for Non-small Cell Lung Cancer

Study of LY2181308 in Combination With Docetaxel Versus Docetaxel in Patients With Non-Small Cell Lung Cancer

Start date: May 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the anti-tumor activity of LY2181308 in combination with docetaxel compared to docetaxel alone in participants with non-small cell lung cancer who were previously treated with first line chemotherapy.

NCT ID: NCT01107210 Completed - Stroke Clinical Trials

Evaluation of Physical Fitness After Stroke

Start date: May 2006
Phase: N/A
Study type: Observational

This study aims to examine the evolution and determinants of physical fitness after stroke.

NCT ID: NCT01107054 Completed - Pulmonary Disease Clinical Trials

A Study to Investigate the Effects of PF00610335 on the QT/QTC Interval in Healthy Volunteers

Start date: June 2010
Phase: Phase 1
Study type: Interventional

A study to determine the cardiovascular effects of PF00610335 in healthy volunteers.