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NCT ID: NCT01603537 Active, not recruiting - Traffic Accidents Clinical Trials

The Impact of Prehospital Trauma Life Support (PHTLS) on Outcome of Traffic Injury

Start date: January 2011
Phase: N/A
Study type: Observational

Trauma is the leading cause of death among persons below 60 years of age. It is a well-established belief that optimal treatment in the early phase after trauma has a major impact on mortality, and the implementation of specific educational programs for trauma care have been a widely adopted strategy aimed at improving the outcome. This strategy has high face validity, but the underlying evidence is poor. The Prehospital Trauma Life Support (PHTLS) program was introduced in 1983 aiming to integrate prehospital trauma care with the Advanced Trauma Life Support (ATLS) program. Approximately half a million prehospital caregivers in over 50 countries have taken the PHTLS course. It has been recognized as one of the leading educational programs for prehospital emergency trauma care. However, the scientific support for improved patient outcome from courses such as PHTLS and ATLS is limited. According to a Cochrane analysis published 2010 there is no evidence to recommend advanced life-support (ALS) training for ambulance crews. Another Cochrane analysis concerning ATLS gave similar results and a recent study indicated even worsened outcome after the implementation of ATLS. An observational study in the county of Uppsala indicated reduced mortality after the implementation of PHTLS but the estimate was uncertain due to a low overall mortality. The aim of this study is to further investigate the association between PHTLS training of ambulance crew members and the outcome in trauma patients in a larger study population. To accomplish this the investigators will use an epidemiological semi-individual design applied to all victims of traffic injury that occurred during the implementation period of the PHTLS course in Sweden (1998-2004). Four outcomes and subsets of patients will be analyzed: Mortality before hospital admission, mortality within 30 days, time to death among survivors to hospital admission and return to work among survivors to hospital discharge.

NCT ID: NCT01599559 Active, not recruiting - Clinical trials for Primary Mediastinal B-cell Lymphoma

Randomized, Open-label, Two-arms, Phase III Comparative Study Assessing the Role of Involved Mediastinal Radiotherapy After Rituximab Containing Chemotherapy Regimens to Patients With Newly Diagnosed Primary Mediastinal Large B-Cell Lymphoma

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

Primary mediastinal large B cell lymphoma is treated with a combination of chemotherapy and the monoclonal antibody rituximab (chemoimmunotherapy). Following chemoimmunotherapy patients receive radiation therapy if they have residues which may be active tumour. However at the end of chemoimmunotherapy the majority of patients show tissue scarring that is not necessarily active tumor. In recent years, PET/CT has proved to be a good tool to accurately identify active tumor from scar tissue in patients treated for mediastinal lymphoma.The purpose of this trial is to test whether radiation therapy is really necessary in patients where PET/CT has shown that the tumor is no longer active. Therefore we will compare radiation treatment with careful observation. Patients that at the end of conventional treatment of chemoimmunotherapy have a negative PET/CT (i.e., without residues suspected to contain active tumor), will randomly assigned to two different treatment groups: one treatment group will receive the radiation treatment, and the other treatment group will receive careful observation. The trial is planned according to a non-inferiority design aimed at demonstrating that progression free survival after the experimental treatment (observation) is not worse than after the standard comparator (mediastinal irradiation.Participation in this study could spare patients with complete remission at the end of chemo immunotherapy (PET/CT negative) radiation therapy that may be unnecessary.

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.

NCT ID: NCT01593553 Active, not recruiting - Stroke Clinical Trials

Systematic ECG Screening for Atrial Fibrillation Among 75 Year Old Subjects in the Region of Stockholm and Halland, Sweden

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

The purpose of this study is to determine whether screening for atrial fibrillation by intermittent ECG recording and initiation of anticoagulation treatment among high risk individuals is cost-effective and can lower the incidence of stroke.

NCT ID: NCT01587560 Active, not recruiting - Clinical trials for Osteoarthritis of the Shoulder

A Comparison Between a Pyrocarbon and a CoCr Shoulder Resurfacing Implant

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

The purpose of the study is to investigate fixation to bone and the clinical results following shoulder resurfacing arthroplasty. The study will compare results between an implant made of Cobalt-Chrome(CoCr) and an implant made in pyrocarbon.

NCT ID: NCT01586910 Active, not recruiting - Clinical trials for Severe Aortic Stenosis

Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).

SURTAVI
Start date: April 2012
Phase: N/A
Study type: Interventional

The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgical Aortic Valve Replacement (SAVR) or TAVI with the Medtronic CoreValve® System. Single Arm: The purpose of this trial is to evaluate the safety and effectiveness of transcatheter aortic valve implementation (TAVI) in patients with severe symptomatic Aortic Stenosis (AS) at intermediate surgical risk with TAVI. This is a non-randomized phase of the pivotal clinical trial.

NCT ID: NCT01558921 Active, not recruiting - Rectal Cancer Clinical Trials

Rectal Cancer And Pre-operative Induction Therapy Followed by Dedicated Operation. The RAPIDO Trial

RAPIDO
Start date: June 21, 2011
Phase: Phase 3
Study type: Interventional

Currently the 3-year disease free survival of patients with locally advanced rectal cancer is about 50%. Current standard treatment for patients at high risk of failing locally and/or systemically includes pre-operative long course radiotherapy (5 weeks) in combination with chemotherapy (so called neoadjuvant chemoradiotherapy). The neoadjuvant chemoradiotherapy has been demonstrated to improve local control, but had no effect on the overall survival. Different studies in patients with rectal cancer studying the effect of adjuvant post operative chemotherapy did not result in an improved survival. This may be due the fact that rectal cancer surgery (TME) is associated with a high complication rate so substantial proportion of patients cannot receive chemotherapy postoperatively. An alternative approach is to administer the systemic therapy preoperative. To guarantee control of the rectum tumor short-course radiotherapy (5 days) is given, as different studies showed local control of the tumor for a long time. During this waiting period the patient is in a good condition to receive an optimal dose of chemotherapy. The investigators hypothesize that with this proposed protocol both the local tumour and possible micrometastases are effectively treated and that this will result in an increased survival. The investigators will compare this with the standard treatment of neoadjuvant chemoradiation followed by TME surgery and optional adjuvant chemotherapy.

NCT ID: NCT01553526 Active, not recruiting - Clinical trials for Coronary Artery Disease

BIOFLOW-III All-comers Orsiro Safety and Performance Registry

BIOFLOW-III
Start date: August 2011
Phase: N/A
Study type: Observational

This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES).

NCT ID: NCT01553045 Active, not recruiting - Atrial Fibrillation Clinical Trials

Reasons for Variations in Health Related Quality of Life and Symptom Burden in Patients With Atrial Fibrillation

SMURF
Start date: November 2011
Phase: N/A
Study type: Observational

Atrial fibrillation is the most common cardiac arrhythmia. There is a large variation in symptoms; from almost none to severe but the reason for this is unclear. The investigators aim to find correlations between symptom burden and intracardiac pressure, biomarkers and findings with echocardiography in order to find alternative means of treatment. It is even intended to study the neurohormonal activation directly after the atrial fibrillation (AF) initiation in patients eligible for AF radiofrequency ablation.

NCT ID: NCT01534819 Active, not recruiting - Aortic Aneurysm Clinical Trials

ANCHOR (Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry)

ANCHOR
Start date: April 2012
Phase:
Study type: Observational

The ANCHOR registry is a multi-center, post-market, non-interventional, non-randomized, prospective study. Subjects must sign an ICF prior to obtaining any study specific information. Subjects are eligible to be consented up to 30 days post-procedure. Enrolled subjects will be followed as per local 'standard of care' for up to 5 years post procedure. Study recommended follow-up is per SVS and ESVS guidance.