The Feasibility of an Experimental Hypobaric Simulation to Evaluate the Safety of Closed-Loop Insulin Delivery Systems in Flight-Related Atmospheric Pressure Changes.

Hybrid closed-loop (HCL) systems remain underexplored within aviation, and as atmospheric pressure changes can independently affect insulin pumps and continuous glucose monitoring readings, this preliminary study assessed the feasibility of HCL safety evaluation, in both fasting and post-prandial states, by using hypobaric chamber to simulate flights. Participants with type 1 diabetes and on HCL were studied: Medtronic Guardian 4-Medtronic 780G-SmartGuard ( = 4), Dexcom G6-Omnipod DASH-Android APS ( = 1), and Dexcom G6-Ypsomed Pump-CamAPS ( = 1). Flight cabin pressures of 550 mmHg and 750 mmHg were simulated in a hypobaric chamber.

Glycemic Control Assessed by Intermittently Scanned Glucose Monitoring in Type 1 Diabetes during the COVID-19 Pandemic in Austria.

Objective: The aim of this analysis was to assess glycemic control before and during the coronavirus disease (COVID-19) pandemic.

Methods: Data from 64 (main analysis) and 80 (sensitivity analysis) people with type 1 diabetes (T1D) using intermittently scanned continuous glucose monitoring (isCGM) were investigated retrospectively. The baseline characteristics were collected from electronic medical records.

Retrospective Comparison of Commercially Available Automated Insulin Delivery With Open-Source Automated Insulin Delivery Systems in Type 1 Diabetes.

Background: Automated insulin delivery (AID) systems have shown to improve glycemic control in a range of populations and settings. At the start of this study, only one commercial AID system had entered the Austrian market (MiniMed 670G, Medtronic). However, there is an ever-growing community of people living with type 1 diabetes (PWT1D) using open-source (OS) AID systems.

A prospective, international, bicentric study to evaluate PremiCron suture material for cardiac valve surgery - PREMIVALVE a cohort study.

Unlabelled: The most common age-related heart valve diseases include aortic valve stenosis and mitral valve insufficiency. The suture material is not the focus of most studies. The aim of the study was to assess the performance of PremiCron suture material for cardiac valve reconstruction and/or replacement under clinical routine.

Effects of the short stitch technique for midline abdominal closure on incisional hernia (ESTOIH): randomized clinical trial.

Background: Incisional hernia remains a frequent problem after midline laparotomy. This study compared a short stitch to standard loop closure using an ultra-long-term absorbent elastic suture material.

Methods: A prospective, multicentre, parallel-group, double-blind, randomized, controlled superiority trial was designed for the elective setting.

Comparative Effectiveness of 4 Exercise Interventions Followed by 2 Years of Exercise Maintenance in Multiple Sclerosis: A Randomized Controlled Trial.

Objective: To determine the effects of exergaming (EXE) on quality of life (QOL), motor, and clinical symptoms in multiple sclerosis (MS). We compared the effects of EXE, balance (BAL), cycling (CYC), proprioceptive neuromuscular facilitation (PNF), and a standard care wait-listed control group on clinical and motor symptoms and quality of life (QOL) in people with MS (PwMS) and determined the effects of subsequent maintenance programs for 2 years in a hospital setting.

Design: A randomized controlled trial, using before-after test design.

Eso-Sponge® for anastomotic leakage after oesophageal resection or perforation: outcomes from a national, prospective multicentre registry.

Background: Anastomotic leakage (AL) after oesophagectomy and oesophageal perforations are associated with significant morbidity and mortality. Minimally invasive endoscopy is often used as first-line treatment, particularly endoluminal vacuum therapy (EVT). The aim was to assess the performance of the first commercially available endoluminal vacuum device (Eso-Sponge®) in the management of AL and perforation of the upper gastrointestinal tract (GIT).

Efficient and safe glycaemic control with basal-bolus insulin therapy during fasting periods in hospitalized patients with type 2 diabetes using decision support technology: A post hoc analysis.

Aim: To evaluate the efficacy and safety of basal-bolus insulin therapy in managing glycaemia during fasting periods in hospitalized patients with type 2 diabetes.

Materials And Methods: We performed a post hoc analysis of two prospective, uncontrolled interventional trials that applied electronic decision support system-guided basal-bolus (meal-related and correction) insulin therapy. We searched for fasting periods (invasive or diagnostic procedures, medical condition) during inpatient stays.

Assessment of health-related quality of life and patient's knowledge in chronic non-specific low back pain.

Background: Chronic non-specific low back pain syndrome (cnsLBP) is a severe health problem in developed countries, which has an important effect on patients' quality of life and is highly determined by socio-demographic factors and low back pain specific knowledge. We examined patients' health-related quality of life according to the results of the Short Form Health Survey (SF-36), low back pain knowledge (LBPKQ) and the social determinants of the participants.

Methods: We carried out our research in the first half of 2015 in Southern Transdanubia, Hungary.

Criterion validity and reliability of the International Physical Activity Questionnaire - Hungarian short form against the RM42 accelerometer.

Background: Physical inactivity is a global phenomenon in European welfare countries. Proper monitoring is essential to measure the physical activity level of the population.

Methods: In the Hungarian cohort of the European Physical Activity and Sport Monitoring System (EUPASMOS) project, our participants (N = 598) completed sociodemographic questions and the International Physical Activity Questionnaire - short form (IPAQ-SF) survey.

Patients with healed diabetic foot ulcer represent a cohort at highest risk for future fatal events.

Patients with previous diabetic foot ulcer are prone to re-ulceration and (re)amputation, to various comorbidities, have significantly impaired quality of life and increased mortality. We aimed to evaluate the risk of foot related complications and mortality in a high-risk population of patients with healed diabetic foot syndrome over a decade. 91 patients with recently healed diabetic foot ulcer were invited for follow-up at 1, 6 and 11 years after inclusion.

Prospective international multicenter observational study of Novosyn® Quick for skin closures in adults and children (SKINNOQ).

Background: This clinical trial evaluated the performance of a newly released fast-absorbable braided synthetic suture (Novosyn® Quick) in adults and paediatric patients undergoing elective skin closures.

Methods: This was a prospective international multicentre observational study. Two centres enrolled 100 patients, of which 50 were adults (visceral surgery, France) and 50 were paediatric patients (paediatric surgery, Germany).

Lower plasma insulin levels during overnight closed-loop in school children with type 1 diabetes: Potential advantage? A randomized cross-over trial.

Background: Studies have shown that overnight closed-loop insulin delivery can improve glucose control and reduce the risk of hypoglycemia and hence may improve metabolic outcomes and reduce burden for children with type 1 diabetes and their families. However, research so far has not reported insulin levels while comparing closed-loop to open-loop insulin delivery in children. Therefore, in this study we obtained glucose levels as well as plasma insulin levels in children with type 1 diabetes to evaluate the efficacy of a model-based closed-loop algorithm compared to an open-loop administration.

Optilene, a new non-absorbable monofilament is safe and effective for CABG anastomosis. OPTICABG - A prospective international, multi-centric, cohort study.

Introduction: Coronary artery bypass grafting (CABG) is performed to improve quality of life and to reduce cardiac-related mortality and morbidity in patients with coronary artery disease (CAD). The aim of the present observational study was to assess the performance of a new suture material (Optilene) for anastomosis construction in CABG surgery using a routine clinical procedure. Performance was assessed using the incidence of major adverse cardiac and cerebrovascular events (MACCE).

Mid-term absorbable monofilament is safe and effective for gastrointestinal anastomosis - PROMEGAT - A single-arm prospective observational study.

Introduction: Various suture materials and suture techniques are used to perform gastrointestinal anastomosis after tumour resection, but the best combination is still a matter of debate.

Methods: This multi-centre, international, single-arm, prospective observational study aimed at demonstrating the non-inferiority of a mid-term absorbable monofilament in comparison to braided sutures in gastrointestinal anastomosis. Monosyn suture was used to create the gastrointestinal anastomosis and the frequency of anastomotic leakage until day of discharge was chosen as the primary parameter.

Evaluation of subcutaneous glucose monitoring systems under routine environmental conditions in patients with type 1 diabetes.

Continuous and flash glucose monitoring (GM) systems have been established in diabetes care. We compared the sensor performance of 3 commercially available GM systems. A total of 12 patients with type 1 diabetes were included in a single-centre, open-label study in which the sensor performance of the Abbott FreeStyle libre (Abbott), Dexcom G4 Platinum (Dexcom) and Medtronic MiniMed 640G (Medtronic) systems over 12 hours was compared during mimicked real-life conditions (meals, exercise, hypo- and hyperglycaemia).

A-Part Gel, an adhesion prophylaxis for abdominal surgery: a randomized controlled phase I-II safety study [NCT00646412].

Background: Intra-abdominal surgical intervention can cause the development of intra-peritoneal adhesions. To reduce this problem, different agents have been tested to minimize abdominal adhesions; however, the optimal adhesion prophylaxis has not been found so far. Therefore, the A-Part(®) Gel was developed as a barrier to diminish postsurgical adhesions; the aim of this randomized controlled study was a first evaluation of its safety and efficacy.

Effect of suture technique on the occurrence of incisional hernia after elective midline abdominal wall closure: study protocol for a randomized controlled trial.

Background: Based on a recent meta-analysis, a continuous suture technique with a suture to wound length ratio of at least 4:1, using a slowly absorbable monofilament suture material, is recommended for primary median laparotomy closure. Incisional hernia, which develops in 9 to 20% of patients, remains the major complication of abdominal wall closure. Current clinical data indicate that the incidence of incisional hernias increases by 60% between the first and the third year after median laparotomy, implicating that a follow-up period of 1 year postoperatively is too short with regard to this common complication.

Collagen hemostat significantly reduces time to hemostasis compared with cellulose: COBBANA, a single-center, randomized trial.

Background: This single-center, randomized trial compares the hemostatic effectiveness of microfibrillar collagen and oxidized cellulose in arterial bypass surgery.

Methods: In patients undergoing arterial bypass surgery, 2 hemostats, microfibrillar collagen and oxidized cellulose, were randomly used to achieve hemostasis. The primary endpoint was the time to hemostasis.

Evaluation of the safety and efficacy of MonoMax® suture material for abdominal wall closure after primary midline laparotomy-a controlled prospective multicentre trial: ISSAAC [NCT005725079].

Purpose: Different suture techniques and various suture materials are in use to close midline incisions after primary laparotomy. The ISSAAC study aimed to assess the safety and efficacy of the new ultra-long-term absorbable, elastic monofilament suture material MonoMax® for abdominal wall closure.

Methods: This is a single-arm, multicentre prospective study that included 150 patients undergoing a primary elective midline incision.