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NCT ID: NCT03769454 Recruiting - Clinical trials for Keratoconjunctivitis

A Phase I Safety and Tolerability Study of PP-001 Eye Drops in Healthy Adult Volunteers

Start date: November 15, 2018
Phase: Phase 1
Study type: Interventional

In this study, PP-001 eye drops are assessed for safety and tolerability in healthy, adult volunteers. PP-001 is a novel, anti-inflammatory small molecule that inhibits a specific enzyme (Dihydroorotate Dehydrogenase).

NCT ID: NCT03767673 Recruiting - Esophageal Atresia Clinical Trials

Cardiorespiratory Performance and Pulmonary Microbiome in Patients After Repair of Esophageal Atresia

Start date: August 10, 2017
Phase: N/A
Study type: Interventional

The majority of the clinical research on esophageal atresia focuses on the upper gastrointestinal tract. However, the trachea and the lung are also affected in many of these children, so that a lifelong pulmonary impairment may result. The importance of respiratory function in the context of follow-up of these patients has therefore been increasingly recognized in recent years. Scientific work has shown significantly, that patients following esophageal atresia repair develop respiratory symptoms more frequently than the normal population. Mild impairment of the pulmonary function in adolescence and adulthood was demonstrated in some studies, but to date, there is no exact idea about the relationship between early childhood disease progression and later pulmonary impairment. Only a few scientific papers have dealt with the effect of impaired pulmonary function on the physical capacity of these adolescents and adults. Most of these studies show small case numbers, inconclusive stress tests, and divergent results. The aim of this prospective study is to investigate the cardiopulmonary performance capacity and the pulmonary microbiome of adolescent and adult patients with corrected esophageal atresia and to compare the results with a control group. Another focus of the investigators is on the composition of the pulmonary microbiome of the participants. Changes of the pulmonary microbiome and the influence on the cardio-pulmonary performance capacity have not yet been investigated. Furthermore, it should be investigated whether the treatment measures and a complicated disease course in the neonatal period have long-term effects on lung function, exercise capacity and composition of the microbiome in the lungs.

NCT ID: NCT03766828 Completed - Clinical trials for Central Venous Catheter Thrombosis

Dialysis Catheter Placement in Patients With Thoracic Central Venous Occlusion

Start date: September 1, 2016
Phase:
Study type: Observational

A unique inside-out-access technique with a new CE certified device (Surfacer (R) Bluegrass Vascular, San Antonio, Tx, USA) enables repetitive and confident right-sided placement of central venous catheters in hemodialysis patients with thoracic central venous occlusion.

NCT ID: NCT03766152 Recruiting - Clinical trials for Hearing Loss, Conductive

Audiological Benefit and Improved Quality of Life With Two Bone Conduction Systems: ADHEAR vs. Bonebridge in Experienced Users

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

Patients implanted with a Bonebridge will be asked to be part of the study. The study subjects are enrolled into the study according to inclusion criteria. Patients will be asked to wear an adhesive bone conduction device an adapt to it for 30-60 min. After this time period patients will be asked to use the adhesive device instead of the Bonebridge for 3 weeks. Audiologic Tests and quality of life questionnaires will be assessed at the beginning of the study and at the end of three weeks.

NCT ID: NCT03764358 Not yet recruiting - Clinical trials for End Stage Renal Disease

AUSTrian Randomized Interventional Study on Dialysis Accesses

AUSTRIA
Start date: March 6, 2019
Phase: N/A
Study type: Interventional

Patients with diagnosed end stage renal disease and indication for chronic dialysis rely on a well-functioning access for dialysis. The KDOQI Guidelines For Vascular Access follows a "fistula first" approach for every patient, whenever possible. Thus, every patient, regardless of age, clinical state and co-morbidities an arteriovenous fistula should be preferred over a tunneled cuffed catheter (TCC). These recommendations are based on retrospective and register studies. There have been no prospective studies in this subject so far. In addition, most of the collected data refers to patients of all ages, regardless of their comorbidities and general clinical state. In this study, we address differences between two dialysis vascular access types in elderly or frail patients. We will compare TCCs with arteriovenous fistulas in the selected population consisting of elderly patients over 60 years of age or those with a Charlson Comorbidity Index >6 independent of age. In our hypothesis TCCs will be superior to arteriovenous fistulas in this population regarding the examined end-points.

NCT ID: NCT03764319 Recruiting - Lung Diseases Clinical Trials

Low Frequency, Ultra-low Tidal Volume Ventilation in Patients With ARDS and VV-ECMO

Start date: November 6, 2018
Phase: N/A
Study type: Interventional

The acute respiratory distress syndrome (ARDS) is the most severe form of respiratory failure, presented in 10% of all intensive care patients and carrying a high mortality rate. Veno-venous extracorporeal membrane oxygenation (VV-ECMO) is a rescue treatment for patients with severe ARDS. Mechanical ventilator settings in patients with severe ARDS during VV-ECMO therapy are not clearly defined at the moment.

NCT ID: NCT03763903 Active, not recruiting - Laparoscopy Clinical Trials

Comparison of the Effectiveness of 2D Versus 3D Basic Laparoscopic Skills Training

Start date: November 13, 2018
Phase: N/A
Study type: Interventional

The aim of this study is to find out whether basic laparoscopic skills training (FLS tasks) on a standard pelvic trainer using conventional 2D visualization is at least equally effective in terms of skills improvement compared to practicing with 3D visualization. Furthermore, the progress in basic laparoscopic skills improvement for each visualization modality will be analyzed.

NCT ID: NCT03760302 Not yet recruiting - Emergencies Clinical Trials

Analgesia in ÖAMTC Helicopter Emergency Service in Austria

Start date: December 2018
Phase:
Study type: Observational

A sufficient analgesia in injured or sick people is the main goal of physicians treating a patient. In emergency medicine potent analgesia like ketamine or opioids are routinely used. It is unknown if there are any severe side effects or if the use is safe while in use in a Helicopter Emergency Service equipped with emergency physicians.

NCT ID: NCT03758599 Recruiting - Anxiety Clinical Trials

Exercise in Anxiety and Posttraumatic Stress Disorders

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

Aim: Aerobic and resistance exercise showed anxiolytic effects in clinical populations. Climbing could further enhance self-efficacy. Aim of the study is to examine whether climbing exercise and aerobic exercise, compared to social contact control, reduces symptoms of disease in out-patients with anxiety disorder (AD) and post-traumatic stress disorder (PTSD). Further analyses are aiming to reveal differences between climbing - and aerobic exercise. Design: Randomized controlled clinical trial Participants: Thirty out-patients diagnosed with International Classification of Disease-Version 10 (ICD-10) (F40, F41, F43.1) for AD or PTSD. Intervention: Out-patients will be assigned randomly to a climbing exercise group (a), aerobic exercise group (Nordic walking) (b) or social contact control group (c). Measurements: Primary outcome is symptom severity in AD or Post Traumatic Stress Disorders. Further secondary outcomes are evaluated by psychological questionnaires assessing depression, worry symptoms, quality of life, self-efficacy and affective responses. Metabolites of neurotransmitters, immune-activation markers and anthropometric data will be additionally provided as secondary physiological outcomes. Duration: Intervention duration is four weeks with 2 x 75 min for every group (climbing exercise, aerobic exercise, social contact control). Measurement points are set at the beginning (t1), at the end of the intervention (t2) and 3 (t3) and 6 (t4) months follow-up.

NCT ID: NCT03758313 Recruiting - Preterm Infant Clinical Trials

Non-Invasive Monitoring of Partial Pressure of Carbon Dioxide in Mechanically Ventilated Preterm Infants

Start date: November 1, 2018
Phase:
Study type: Observational

Background: In mechanically ventilated preterm infants, the ability to monitor carbon dioxide partial pressure (pCO2) values is indispensable. The gold standard for pCO2 measurement is from an arterial blood sample (paCO2). This has two drawbacks: firstly, it requires an arterial line and, secondly, it does not provide the clinicians with a continuous measurement. At present, two alternative pCO2 monitoring systems are available in the field of neonatal intensive care medicine: end-tidal CO2 (etCO2) capnography and transcutaneous CO2 (tcCO2) measurements. Both methods have disadvantages including potential technical errors as well as pathologies that may reduce reliability as a surrogate for blood gas analysis (BGA). In particular, conventional side-stream etCO2 capnography underestimates pCO2 in presence of a tube leakage, which is a common occurrence in ventilated preterm infants where only tubes without cuff are used. Distal etCO2 (detCO2) by means of a double lumen endo-tracheal tube may solve the problem of unreliable etCO2 values in the presence of tube leakage. Several studies compared etCO2 and tcCO2 to paCO2, simultaneously. A comparison study of etCO2 and tcCO2 in a cohort of critically ill children did not reveal significant differences in the absence of severe pulmonary parenchymal disease. Tobias et al compared etCO2 and tcCO2 in a cohort of pediatric intensive care patients with respiratory failure and found tcCO2 measurements to be more accurate. In a cohort of ventilated newborns, tcCO2 monitoring was generally more precise than etCO2 during neonatal transport to monitor ventilation. In a more recent study restricted to a cohort of postsurgical neonates without lung disease, etCO2 underestimated paCO2 more than tcCO2 but provided greater precision over paCO2, however it was less accurate at smaller tidal volumes. These studies have in common that the adapter of the pCO2 analyzer was attached in-line and proximal to the endotracheal tube. Aim of the study: The aim of this study is to compare the agreement, precision and repeatability of the distal etCO2-measurement technique described by Kugelman et al. with respect to paCO2 and tcCO2 in mechanically ventilated preterm infants. Since ventilation strategies and pCO2 limits may vary among different centers, this study helps to determine which non-invasive CO2 monitoring system (detCO2 or tcO2) is more suitable in terms of applicability and reliability in preterm infants at our neonatal intensive care units. Study design: Prospective, observational clinical trial. Methods: Distal etCO2, tcCO2 and paCO2 values will be recorded simultaneously in ventilated preterm infants. We will measure etCO2 in a distal position using a double lumen tube connected to an external side-stream capnometer. Patients: 30 preterm infants who require mechanically ventilation in our neonatal intensive care units will be included. Main outcome variables: detCO2 , tcCO2 and paCO2. Co-variables: Tube leakage, physiologic dead-space-to-tidal-volume ratio, ventilation settings.