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NCT ID: NCT02283268 Completed - Clinical trials for Von Willebrand Disease

Recombinant Von Willebrand Factor in Subjects With Severe Von Willebrand Disease Undergoing Surgery

Start date: April 1, 2015
Phase: Phase 3
Study type: Interventional

The purpose of the study is to assess the efficacy and safety of recombinant von Willebrand factor (rVWF) with or without ADVATE in major and minor elective surgical procedures in adult patients with hereditary severe von Willebrand disease (VWD).

NCT ID: NCT02282033 Completed - Bradycardia Clinical Trials

Safety and Performance Study of the Moderato System

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

The purpose of the study is to evaluate the safety and performance of the Moderato System by implanting the Moderato pacemaker in patients who require a dual chamber pacemaker, and who also have hypertension, in order to reduce their blood pressure.

NCT ID: NCT02278796 Completed - Clinical trials for Lymphoma, Large B-Cell, Diffuse

A Trial Comparing the Two High-dose Chemotherapies BeEAM and BEAM Given Before Autologous Stem Cell Transplantation (ASCT) in Lymphoma Patients (BEB-trial)

BEB
Start date: April 2015
Phase: Phase 2
Study type: Interventional

In the treatment of patient with lymphoma the most common high-dose chemotherapy regimen used prior to autologous transplantation (ASCT) is the BEAM regimen. It consists of four chemotherapy drugs together (BCNU, etoposide, cyclophosphamide, melphalan), whose initial letters are grouped together for BEAM regimen. One of the most common organ damage this intensive treatment is caused by the drug BCNU; it involves a lung injury, which manifests itself in the months after ASCT with increasing shortness of breath and cough, and can result in pulmonary fibrosis. The drug bendamustine is used successfully in different lymphoma types, and its efficacy in lymphoma therapy is well documented. Moreover bendamustine doesn't cause lung injury. Initially experience with bendamustine instead of BCNU - in the so-called BeEAM scheme - shows that this scheme is quite effective and well tolerated, without lung injury. In BeEAM scheme therefore bendamustine replace the BCNU, while the other three drugs are administered in the same dosage and order. The aim of the present study conducted at four centers (Bern and Zurich in Switzerland, Vienna and Linz in Austria) is to compare these two high-dose chemotherapy schemas and to show that the BeEAM scheme causes significantly less lung injury than the BEAM regimen.

NCT ID: NCT02277990 Completed - Clinical trials for CIED Related Infection

World-wide Randomized Antibiotic Envelope Infection Prevention Trial

WRAP-IT
Start date: January 2015
Phase: Phase 4
Study type: Interventional

Medtronic , Inc. is sponsoring the World-wide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT), a randomized, prospective, multi-center, single blinded, post-market, interventional clinical study. This study will evaluate the ability of the TYRX™ envelope to reduce major Cardiac Implantable Electronic Device (CIED) infections through 12-months post-procedure following CIED generator replacement, upgrade, revision, or de novo cardiac resynchronization therapy defibrillator (CRT-D) implant. Additionally, this large device study provides the unique opportunity to prospectively characterize the performance of Medtronic's lead monitoring features in subjects whose CIED system includes a transvenous right ventricular (RV) defibrillation lead. Finally, the WRAP-IT study will serve as a post-approval study for those geographies requiring a post-approval study of the TYRX™ envelope.

NCT ID: NCT02276313 Completed - Atherosclerosis Clinical Trials

BIOLUX P-III All-Comers Passeo-18 Lux Registry

Start date: October 2014
Phase:
Study type: Observational

BIOLUX P-III is a prospective, international, multi-centre, postmarket all-comers registry to collect clinical performance data on the Passeo-18 Lux paclitaxel releasing balloon catheter in the treatment of atherosclerotic disease of the infrainguinal arteries.

NCT ID: NCT02274766 Completed - Clinical trials for Parkinson's Disease (PD)

Efficacy and Safety Study of ADS-5102 in PD Patients With Levodopa-Induced Dyskinesia

EASE LID 3
Start date: October 2014
Phase: Phase 3
Study type: Interventional

This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group study to evaluate the efficacy and safety of ADS-5102 extended release (ER) capsules, an investigational formulation of amantadine, dosed once nightly at bedtime for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel pharmacokinetic profile of ADS-5102 is expected to achieve i) maximal concentrations in the early morning through mid-day, when LID can be troublesome, and ii) lower concentrations in the evening, potentially reducing the negative impact of amantadine on sleep. This pharmacokinetic profile could enable higher doses to be tolerated with a once-nightly ER formulation than can be tolerated with an immediate-release formulation. The once-nightly dosing regimen may also provide enhanced convenience and compliance. In a previous clinical study, ADS-5102 met its primary endpoint; LID was significantly reduced as measured by the change in UDysRS score over 8 weeks vs. placebo.

NCT ID: NCT02273973 Completed - Breast Cancer Clinical Trials

A Study of Neoadjuvant Letrozole + Taselisib Versus Letrozole + Placebo in Post-Menopausal Women With Breast Cancer (LORELEI)

Start date: November 12, 2014
Phase: Phase 2
Study type: Interventional

This is a two-arm, randomized, double-blind, multicenter, pre-operative study to evaluate the effect of combining letrozole and GDC-0032 (also known as taselisib) versus letrozole and placebo in postmenopausal women with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2 (HER2) untreated, Stage I-III operable breast cancer. Participants will be randomized into one of the two treatment arms with a 1:1 randomization ratio. Letrozole at 2.5 milligrams (mg) will be dosed once daily plus either Taselisib at 4 mg (two 2-mg tablets) or placebo on a 5 days-on/ 2 days-off schedule for a total of 16 weeks.

NCT ID: NCT02273596 Completed - Wilson Disease Clinical Trials

Efficacy and Safety Study of WTX101 (ALXN1840) in Adult Wilson Disease Patients

Start date: November 24, 2014
Phase: Phase 2
Study type: Interventional

The main purpose of the study was to evaluate the efficacy of ALXN1840 (formerly WTX101) for 24 weeks on non-ceruloplasmin-bound copper (NCC) concentrations adjusted for molybdenum plasma concentration in participants newly diagnosed with Wilson Disease (WD) who were aged 18 and older and who had NCC concentrations within or above the reference range at the time of enrollment in the study. The study consisted of a 24-week Treatment Period, followed by a planned 36-month Extension Period.

NCT ID: NCT02272972 Completed - Hip Fractures Clinical Trials

Performance Improvement Program on Imaging II

Start date: October 2014
Phase:
Study type: Observational

This study consists of a retrospective and a prospective part. For each part and in each of 5 clinics, one intraoperative postimplant image (lateral view) of 25 patients with pertrochanteric fractures will be assessed by 5 surgeons per clinic. There are two assessments in the retrospective part. a) before an educational intervention, b) after the educational intervention. The evaluated images at these two timepoints are identical. In the prospective part, the surgeons apply their new knowledge from the educational intervention. They perform the positioning of the patient during the intraoperative fluoroscopy and record the image according to the teaching material. One postimplant image of each patient will be used for the evaluation. At all three timepoints of image assessment, a questionnaire with the same set of 7 criteria (Q1-Q7) for assessing the radiographs is used. The criteria refer to the content of the educational material.

NCT ID: NCT02269813 Completed - Breast Cancer Clinical Trials

PRospective Study to Measure the Impact of MammaPrint on Adjuvant Treatment in Hormone Receptor-positive HER2-negative Breast Cancer Patients (PRIMe)

PRIMe
Start date: April 1, 2015
Phase:
Study type: Observational

PRIMe is a prospective, case-only trial designed to measure the impact of MammaPrint on physician chemotherapy intention in the two discordant groups (ET/POOR, CT/GOOD) in stage 1 and 2 HR-positive HER2-negative breast cancer patients. The design also provides for assessment of several important secondary indicators. Eligible patients will have their tumor sample analyzed for MammaPrint, BluePrint and TargetPrint. Patients cannot start treatment before the MammaPrint result is received and taken into consideration for the adjuvant treatment plan.