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NCT ID: NCT03334006 Recruiting - Sepsis Clinical Trials

Prospective, Randomized Trial of Personalized Medicine With Pentaglobin® After Surgical Infectious Source Control in Patients With Peritonitis (PEPPER Trial).

PEPPER
Start date: November 20, 2017
Phase: Phase 2
Study type: Interventional

The aim of this prospective, randomized, controlled trial is to provide evidence for adjuvant IgGAM treatment with regard to 1. Improvement of patient outcomes for peritonitis. Improvement in outcome will be determined by scores such as MOF, SOFA and survival. 2. Identification of biomarkers (including immunoglobulin levels, HLA-DR, Nf-kB1 and other immunological biomarkers) to identify patient subpopulations that benefit most from IgGAM treatment. These patients will form the basis for a further randomized, controlled, double-blind Phase III trial (RCT) to demonstrate the benefit of this treatment. 3. In addition, these biomarkers could help to guide a targeted, i.e. "personalized", adjuvant therapy with Pentaglobin® (IgGAM) in the indication of peritonitis.

NCT ID: NCT03320304 Recruiting - Clinical trials for Treatment Resistant Depression

A Study to Assess Effectiveness and Efficiency of VNS Therapy in Patients With Difficult to Treat Depression.

RESTORE-LIFE
Start date: December 14, 2017
Phase:
Study type: Observational [Patient Registry]

The primary objective of this study is to assess short, mid and long-term clinical outcomes in patients with difficult to treat depression (such as patients with treatment resistant depression) treated with Vagus Nerve Stimulation (VNS) Therapy as adjunctive therapy.

NCT ID: NCT03320252 Recruiting - Clinical trials for AAA - Abdominal Aortic Aneurysm

Endurant CHevAr New Indication Trial: ENCHANT

ENCHANT
Start date: October 26, 2017
Phase:
Study type: Observational

The purpose of the post-market study is to assess the clinical outcomes, safety, and performance of the Endurant Chimney Graft Technique (Endurant Stent Graft Systems used with a balloon-expandable covered stent graft) for treatment of juxtarenal aortic aneurysms with a short infrarenal neck in a real world setting.

NCT ID: NCT03319940 Recruiting - Clinical trials for Small Cell Lung Carcinoma

Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)

Start date: December 26, 2017
Phase: Phase 1
Study type: Interventional

A study to assess the safety, tolerability, and PK of tarlatamab in participants with SCLC

NCT ID: NCT03318406 Recruiting - Emphysema or COPD Clinical Trials

Post-Market BTVA Registry

Start date: March 22, 2018
Phase:
Study type: Observational [Patient Registry]

Bronchoscopic thermal vapor ablation using Uptake Medical Technology Inc.'s InterVapor System is indicated for treatment of patients with heterogeneous upper lobe emphysema. This study is a retrospective and prospective, observational, multi-center, post-market registry of patients prescribed InterVapor. The primary objective of the Registry is to describe the long-term impact of InterVapor treatment on patient quality of life (QOL) in a real-world setting. After InterVapor treatment, patients will be followed for 5 years as per the standard of care and safety and efficacy data (quality of life, pulmonary function, exercise capacity) collected as part of the registry.

NCT ID: NCT03315429 Recruiting - Heart Failure Clinical Trials

Unmasking the dynAmic Component in functionaL mitraL rEGuRgitatiOn in Chronic Heart Failure

ALLEGRO
Start date: November 1, 2017
Phase: N/A
Study type: Interventional

Background: Chronic heart failure (HF) is frequently accompanied by functional mitral regurgitation (FMR) caused by left ventricular (LV) remodeling and subsequent papillary muscle displacement resulting in mitral valve (MV) leaflet tethering, dilatation and flattening of the mitral annulus and reduced closing forces. Up to moderate FMR affects the majority of patients with systolic heart failure - roughly 80% - still independently increasing mortality. Every fifth patient with chronic heart failure experiences a progression of FMR during the first three years of follow up despite guideline directed heart failure therapy, which is independently associated with a poor prognosis. Furthermore, MR is well known to have a strong dynamic component not only during the cardiac cycle at rest and with exercise. Aims of the study: The investigators therefore aim to assess whether stress tests in patients with functional mitral regurgitation unmasks significant dynamic mitral regurgitation or might aid to identify patients at risk of FMR progression in patients with functional mitral regurgitation in heart failure with reduced ejection fraction (HFrEF) under guideline directed medical therapy. Study design: The investigators will prospectively perform stress tests in all patients with non-severe FMR that are routinely seen in the heart failure outpatient clinic. Study patients: Patients with stable chronic heart failure on optimal medical therapy, who undergo routine ambulatory clinical control visits in the heart failure outpatient ward of the Medical University of Vienna, will be included in the present study. A written informed consent will be obtained before inclusion. Inclusion criteria will be a non-severe FMR, an age of at least 18 years and stable heart failure related medical therapy in the last 3 months. Methods: All patients that are willing to participate will undergo stress testing (i.e. volume challenge and low dose dobutamine stress) to determine whether patients display severe dynamic FMR under stress conditions. Within the registry patients will be followed-up during routine ambulatory visits for three years. Patients with severe dynamic functional mitral regurgitation will be compared to patients without severe dynamic FMR. Record of clinical events during the FUP will be performed. Routine laboratory parameters, have been measured at inclusion. Additionally, neurohormone patterns will be measured at baseline and at peak stress. Sample size: Expecting a prevalence of severe dynamic FMR of 20%, the investigators would include a total of 150 chronic heart failure patients taking also into account a study-dropouts of 20% ( loss of follow-up and mortality).

NCT ID: NCT03306719 Recruiting - Clinical trials for Preterm Premature Rupture of Membrane

mtDNA as Novel Biomarker for Intra-amniotic Infection

mtDNA
Start date: April 5, 2017
Phase: N/A
Study type: Observational

Finding a predictive biomarker for IAI could improve the clinical outcome for the mother and the neonate. The aim of this study is to quantify the copy number of circulating cell-free mitochondrial DNA in maternal serum and the placenta compared to controls.the investigators hypothesise that circulating cell-free mitochondrial DNA levels could help predict the likelihood of early inflammation in IAI. In addition, mitochondrial DNA could be a promotor triggering the pathogenesis of systemic inflammation.

NCT ID: NCT03301506 Recruiting - Clinical trials for Primary Biliary Cirrhosis

Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)

Start date: December 12, 2017
Phase: Phase 3
Study type: Interventional

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)

NCT ID: NCT03301493 Recruiting - Clinical trials for Hematologic Neoplasms

Genomic Testing and Resulting Medical Decisions

Start date: March 30, 2017
Phase:
Study type: Observational [Patient Registry]

There is no evidence available about which molecular profiling methods are currently used for cancer patients in Austrian clinical practice. The construction of the registry proposed as a completely independent research endeavor, will be helpful for scientific evaluation and the establishment of highly credible data.

NCT ID: NCT03298295 Recruiting - Diabetes Mellitus Clinical Trials

Inflammatory Response to CSII Catheters in a Tummy Tuck Model

IRCATT
Start date: February 1, 2018
Phase: N/A
Study type: Interventional

In insulin pump therapy, insulin is continuously infused into the subcutaneous adipose tissue via a continuous subcutaneous insulin infusion (CSII) catheter using a basal/bolus pattern. Unfortunately, insulin absorption from the tissue surrounding a CSII catheter can be slow, variable, and unreliable. It is recommended to replace CSII catheters after 2 to 3 days of use. Frequently changing the injection site can be tedious and moreover leads to scarring, while reusing the same injection site can lead to medical complications such as lipohypertrophy. CSII catheters are manufactured from both steel and Teflon and use of either of these materials is based on personal preference/experience rather than scientific, empirical data. We hypothesize that the inflammatory response to CSII catheters is a major contributor to variable insulin absorption and that this response is significantly different between materials and catheters shapes. In order to develop CSII catheters with an extended life-time up to 7 days, we need to better understand the inflammatory response caused by the introduction and maintenance of a CSII catheter into the subcutaneous adipose tissue. This study is a pilot study in humans scheduled for elective plastic surgery where a large skin flap is removed from the abdominal region. Teflon and steel CSII catheters will be inserted into the abdomen 7, 4, and 3 days prior to surgery. This study design allows for the removal of tissue plugs surrounding CSII catheters without causing additional scarring for the patient.