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NCT ID: NCT03476265 Completed - Quality of Life Clinical Trials

Lower Esophageal Sphincter (LES) Stimulation in Patients With Ineffective Esophageal Motility

DYSMOSTIM
Start date: May 1, 2017
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate gastroesophageal reflux disease - health related quality of life (GERD-HRQL) after electrical stimulation of the lower esophageal sphincter (LES) in patients with gastroesophageal reflux disease (GERD) and esophageal dysmotility.

NCT ID: NCT03474445 Completed - Clinical trials for Distal Radius Fracture

Comparison of Two Volar Plating Systems for Distal Radius Fractures

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

We plan to compare 2 types of plating systems for volar plating of distal radius fractures (Aptus 2.5® Medartis AG, Basel, Switzerland vs. INTEOS 2.5® - Hofer Medical GmbH and Co KG, Austria) in a prospective single-blinded controlled clinical trial.

NCT ID: NCT03473223 Completed - Clinical trials for Acute Coronary Syndrome

Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome

AEGIS-II
Start date: March 21, 2018
Phase: Phase 3
Study type: Interventional

This is a phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of CSL112 on reducing the risk of major adverse CV events [MACE - cardiovascular (CV) death, myocardial infarction (MI), and stroke] in subjects with acute coronary syndrome (ACS) diagnosed with either ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI), including those managed with percutaneous coronary intervention (PCI) or medically managed.

NCT ID: NCT03472846 Completed - Diabetes Type 2 Clinical Trials

MiDeTe - microRNA Levels Under Denosumab and Teriparatide Therapy in Postmenopausal Osteoporosis

Start date: March 1, 2017
Phase: Phase 4
Study type: Interventional

The aim of this study is the quantitative determination of bone-specific microRNAs in the serum of postmenopausal women with osteoporosis during antiresorptive or osteoanabolic therapy.

NCT ID: NCT03472040 Completed - Clinical trials for Hereditary Angioedema

A Long Term Safety Study of BCX7353 in Hereditary Angioedema

APeX-S
Start date: February 16, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

This is an open-label study to evaluate the long term safety and effectiveness of oral treatment with BCX7353 in preventing acute angioedema attacks in patients with Type I and Type II Hereditary Angioedema (HAE).

NCT ID: NCT03469245 Completed - Clinical trials for Abdominal Aortic Aneurysms

Validation of Fenestrations Positioning by Numerical Simulation

FenSim
Start date: April 26, 2018
Phase:
Study type: Observational

Fenestrated endovascular repair (FEVAR) is nowadays a recognized option to treat juxtarenal, pararenal or suprarenal abdominal aortic aneurysms in patients at high risk for conventional repair. The technique consists in deploying a custom-made stent-graft (SG) inside the patient aorta. Part of the customization involves cauterizing a hole in SG fabric and reinforcing it with a Nitinol stent ring, thereby creating a fenestration for each corresponding collateral artery. For this reason, preoperative planning is crucial to determine adequate positions of fenestrations, in order to obtain perfect alignment with the collateral arteries of the patient. Inadequate positioning may result in failure to catheterize a collateral artery and subsequent organ damage, increased catheterizing time, increased irradiation dose, endoleaks… The current process of fenestrations positioning for fenestrated anacondaTM SG involves: (i) anatomical measurements on patient preoperative CT-scan by case planners using dedicated sizing software; (ii) designing an initial custom device scheme with its positioned fenestrations, created by engineers with CAD software using the above cited measurements and (iii) validation of fenestrations position by in vitro testing using a SG prototype deployed inside a transparent anatomy model (3D-printed model of patient aorta and collateral arteries). The main limitations of this process are the costs and long SG delivery time.

NCT ID: NCT03468803 Completed - Clinical trials for Invasive Candidiases

Influence of Open and Laparoscopic Abdominal Surgery Involving the Intestinal Tract on Serum 1,3-ß-D-Glucan (BDG) Values

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

Candida species are both known to colonize physiologically mucosal surfaces in the human body without causing signs or symptoms of infection and to cause a wide variety of diseases, including mucocutaneous infections and potentially fatal invasive infections of the bloodstream or organs. Throughout the past decades, invasive fungal infections (IFIs) are of increasing importance even in non-neutropenic patients who are in need of treatment in intensive care units (ICU) or have undergone major surgeries. Several factors like parenteral nutrition, central venous catheters, broad spectrum antibiotics admission, disturbance of gastrointestinal mucosa integrity have been associated with an increased incidence of IFIs. Positive testing for 1,3-ß-D-Glucan (BDG) in serum is widely used to assess invasive fungal infections. It detects circulating BDG, which is part of the fungal cell wall of clinical relevant fungi such as Candida spp. and Aspergillus spp.. The issue of BDG kinetics after intestinal mucosal damage (e.g. mucositis or gut surgery) is poorly understood. Intestinal mucosal damage is characterized by a loss of integrity of the intestinal mucosal barrier and increasing translocations of bacterial and/or fungal commensals of the gastrointestinal tract. In abdominal surgery a key concern in serum BDG kinetics is the potential introduction of BDG from surgical sponges and gauze or mucosal damage due to surgical damage of the mucosal integrity. Compared to open abdominal surgery in laparoscopic abdominal surgery sponges and gauze are rarely used. As life-threatening intraabdominal candidiasis occurs in 30 to 40% of high-risk abdominal surgical intensive care unit (ICU) patients it is of utmost importance to obtain reliable BDG values for diagnosis or exclusion of invasive candidiasis.

NCT ID: NCT03465722 Completed - GIST Clinical Trials

(VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST

Start date: March 26, 2018
Phase: Phase 3
Study type: Interventional

This is an open-label, randomized, Phase 3 study in patients with locally advanced unresectable or metastatic GIST (advanced GIST) of avapritinib (also known as BLU-285) versus regorafenib in patients previously treated with imatinib and 1 or 2 other TKIs.

NCT ID: NCT03464149 Completed - Clinical trials for Secondary Hyperparathyroidism

The Longitudinal PTH-Study

Start date: March 20, 2018
Phase:
Study type: Observational

The main study aim is to quantify the agreement between the analytical results provided by two third generation and two second generation Parathyroid hormone (PTH) assays. The primary comparison will be performed between the second-generation PTH assay"Intact PTH assay" from Siemens Healthcare Diagnostics Inc. and the third-generation PTH assay "biointact (1-84)" from Roche Diagnostics in terms of a Bland-Altman analysis. Several studies have evaluated the correlation between various PTH assays at a single time-point, but no previous study has tested the hypothesis that longitudinal changes in PTH levels, which are important for making treatment decisions, can be monitored by several PTH assays alike. To this aim, the key secondary objective is to analyze the longitudinal variance in PTH over the course of 1 year, using each of two assays of the second and third generations, respectively. Other secondary objectives include determining changes in serum phosphate, serum calcium, fibroblast growth factor 23 (FGF23), with respect to treatment decisions. For clinical applicability of the results to be obtained here, an important goal of the present study will be not to influence treatment decisions, which will remain independent of the study investigators, at the full responsibility of the hemodialysis physicians. At every quarterly blood draw over the course of one year, the investigators will freeze the serum from 100 patients, and at the end of 4 quarters the investigators will analyze PTH-levels using the following assays: Intact Parathyroid Hormone (Advia Centaur, Siemens Healthcare), PTH-Intact (Cobas, Roche), PTH (1-84) - The agreement between the PTH assays will be analyzed at baseline, as well as at the subsequent quarterly evaluation time-points by Bland-Altman analysis and complemented by Passing-Bablok regression. The longitudinal changes in PTH will be displayed graphically and analyzed by estimating the within-patient variance across time, the between patient variance at each time-point as well as effects on the mean log-PTH level due to course of disease and therapeutic interventions from a linear mixed model.

NCT ID: NCT03463486 Completed - Clinical trials for Cardiovascular Diseases

Current Outpatient Cardiac Rehabilitation in Austria

Start date: January 2005
Phase:
Study type: Observational [Patient Registry]

Aim of this study is to give evidence to outpatient cardiac rehabilitation in Austria. The database created in this context is supposed to pave the way as instrument to document and comprehend quality of outpatient cardiac rehabilitation in Austria as a key for quality management. Analyses of the created database should be made on a regular basis.