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NCT ID: NCT01262196 Completed - Shock, Traumatic Clinical Trials

Phase IIb Study of MP4OX in Traumatic Hemorrhagic Shock Patients

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

MP4OX is a novel oxygen therapeutic agent being developed as an ischemic rescue therapy to enhance perfusion and oxygenation of tissues at risk during hemorrhagic shock. MP4OX is a pegylated hemoglobin-based colloid. Due to its molecular size and unique oxygen dissociation characteristics, MP4OX targets delivery of oxygen to ischemic tissues. This study will evaluate the safety and efficacy of MP4OX treatment in trauma patients suffering from lactic acidosis due to severe hemorrhagic shock. The study hypothesis is that MP4OX will reverse the lactic acidosis by enhancing perfusion and oxygenation of ischemic tissues and thereby prevent and reduce the duration of organ failure and improve outcome in these patients.

NCT ID: NCT01261845 Completed - Health Behavior Clinical Trials

Ecology of Medical Care - Utilisation of Health Care in Austria

ECOHCARE
Start date: February 2010
Phase: N/A
Study type: Observational

BACKGROUND: A proper understanding of the attitudes towards its own health status and concise estimates concerning the health seeking behavior of the different subgroups of a population are highly desirable. The structure of the Austrian population with regard to its age distribution and the proportion of people with immigrant backgrounds have been rapidly changing in recent years. Questions of allocating limited resources and meeting the needs of under-served populations have become increasingly important. However, data that could illuminate these issues are sparse and therefore obtaining them will be important for making sensible policy decisions. METHODS: A telephone survey of the Austrian population for the assessment of the occurrence of any health complaint and the subsequent help seeking behavior with special emphasize on under-served minority groups - migrant population, elder people, and female gender. AIMS: Our analysis of the data obtained should help to clarify some hitherto undocumented aspects and should provide the evidence for building a better health care infrastructure with equality of access and efficient coordination. We also hope that this information can help to allocate resources strategically according to needs and cost-efficiency in health care.

NCT ID: NCT01261611 Completed - Cervical Dystonia Clinical Trials

Study Comparing Short Term Efficacy of Dysport and Dysport NG to Placebo, and to Assess Efficacy and Safety of Dysport NG of Subjects With Cervical Dystonia

Start date: April 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate how well a new drug called Dysport NG works and how safe it is, when it is used for the treatment of cervical dystonia. Dysport NG will be compared to an approved drug called Dysport.

NCT ID: NCT01261325 Completed - Epilepsy Clinical Trials

Brivaracetam Efficacy and Safety Study in Subjects With Partial Onset Seizures

BRITE
Start date: December 2010
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of brivaracetam at doses of 100 and 200mg/day compared to placebo as adjunctive treatment in adult focal epilepsy subjects with partial onset seizures not fully controlled despite current treatment with 1 or 2 concomitant antiepileptic drugs.

NCT ID: NCT01261273 Completed - Clinical trials for Coronary Artery Disease

e-NOBORI Observational Registry of Nobori DES

e-NOBORI
Start date: August 25, 2010
Phase:
Study type: Observational

Title Prospective, single-arm, multi-centre, observational registry to further validate safety and efficacy of the Nobori® DES in real-world patients. Objective Primary objective The primary objective of e-NOBORI registry is to further validate the safety and efficacy of Nobori® DES system in unselected patients representing everyday clinical practice. Primary Endpoint: Freedom from Target Lesion Failure (TLF) defined as a composite of cardiac death, target vessel related myocardial infarction (MI) and clinically driven target lesion revascularization (TLR) at 1 year

NCT ID: NCT01259960 Completed - Clinical trials for Degenerative Lumbar Disease

Minimal Access Surgical Technique (MAST) in Obese Patients in Degenerative Lumbar Disease. A Prospective Long-term Evaluation

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

Being confronted more and more with obese as well as older patients, minimally invasive surgery is said to keep the surgical trauma low. The prospective long-term evaluation is the continuous monitoring of patients undergoing lumbar minimally invasive fusion surgery and analyzing the effect of body mass index (BMI) and wound healing.

NCT ID: NCT01258218 Completed - Bradycardia Clinical Trials

Accent MRI Pacemaker and Tendril MRI Lead New Technology Assessment

Start date: February 2011
Phase:
Study type: Observational

The intent of this study is to evaluate the performance of the implanted Accent MRI TM system in a clinical setting and optionally in the MRI environment. This system includes the St. Jude Medical Tendril MRI™ lead and SJM Accent MRITM DR pacemaker. Also the MRI Activator™ will be evaluated in this study. The MRI Activator is a handheld device that allows the user to enable and disable MRI Settings as well as check the status of MRI Settings in the pacemaker. The patient population under study includes patients with a standard bradycardia pacing indication.

NCT ID: NCT01258101 Completed - Clinical trials for Hepatitis C, Chronic

A Study of PEGASYS (Peginterferon Alfa-2a) Plus Ribavirin in Patients With Chronic Hepatitis C (CHC), Genotype 2 or 3

Start date: May 2003
Phase: Phase 4
Study type: Interventional

This randomized, parallel arm study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in combination with 2 different doses of ribavirin in patients with chronic hepatitis C, genotype 2 or 3. Patients will be randomized to 4 treatment groups receiving Pegasys (180 mcg subcutaneously weekly) for either 16 or 24 weeks with one of two doses of ribavirin (400 mg or 800 mg orally daily). The anticipated time on study treatment is 16 or 24 weeks with a 24-week follow-up.

NCT ID: NCT01255644 Completed - Clinical trials for Chronic Lymphocytic Leukemia

Antiviral Treatment of Chronic Lymphocytic Leukemia

VGCV-CLL
Start date: December 2010
Phase: Phase 4
Study type: Interventional

Chronic lymphocytic leukemia (CLL) is increasingly believed to be closely related to chronic stimulation of healthy B-cells. Identification of antigen(s) are relevant for the stimulation of CLL precursor cells is therefore of high interest. The investigators found recently evidence that a herpes virus is involved in this process of stimulation. Consequently, elimination of the antigenic stimulation of leukemic cells by this herpes virus may be expected to reduce or even inhibit propagation of leukemic cells. The investigators hypothesize that inhibition of CMV replication by a short course of antiviral treatment may reduce significantly proliferation rates of leukemic cells. To test this hypothesis, the investigators will treat 20 CLL patients with an antiviral drug for 3 months in a proof-of-concept clinical trial and leukemic cell counts measured before and after antiviral treatment. Antiviral treatment has the potential to treat the disease at its origin and therefore more efficiently than conventional chemotherapeutic regimens.

NCT ID: NCT01254292 Completed - Contraception Clinical Trials

LCS12 vs Combined Oral Contraceptive (COC) User Satisfaction Study

Start date: January 6, 2011
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate user satisfaction and tolerability in young women (18-29 years of age) using the LCS12 compared with young women using a COC (Yasmin) over a period of 18 months. Subjects in the LCS12 arm will be offered continued use of LCS12 for the full, intended duration of use (up to 3 years) by continuing in a optional, extension phase. Safety data only will be collected during the extension phase of the study. Secondary objectives are to observe the tolerability, discontinuation rates, adverse event profiles, occurrences of unintended pregnancies (including calculation of Pearl Index [PI]), and bleeding profiles with the two birth-control methods. Additionally, data on missed tablets in the combined oral contraceptive (COC) group, and intrauterine delivery system (IUS) expulsions in the LCS12 group will be recorded. In the LCS12 group, physician satisfaction with the IUS inserter, evaluation of the visibility and texture of the removal threads, and evaluation of the visibility of the LCS12 on ultrasound (in a subset of subjects) will be collected. Finally, in the COC group, information will be collected on the psychosocial impact of missed or delayed pill intake.