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Filter by:This will be a single center, bioequivalence and food-effect, open-label study designed to be conducted in three sequential parts:
To evaluate the histopathology of subcutaneous tissue isolated after single or multiple Collagenase Clostridium Histolyticum (CCH) injection techniques in adult female participants undergoing abdominoplasty.
Accidental vaccine injection into adjunct shoulder structures can cause tissue damage, termed Shoulder injury related to vaccine administration (SIRVA). The immunopathological mechanisms and consequences of SIRVA are unknown. The study assesses the clinical and immunological consequences of an influenza vaccine if accidentally administered in periarticular space.
Ninety-five patients, aged between 16 and 70 years old, were included in this study. Patients were divided into two groups. Group one received Articaine 4% with 1:00.000 Adrenalines. Group two received Prilocaine with 3% Felypressin (0.03 I.U. per ml). Onset time of anaesthesia was objectively evaluated by using electronic pulp testing.
Minimal invasive intra-arterial prostaglandin therapy is currently being offered as an established and safe treatment approach for Non-occlusive mesenteric ischemia (NOMI). So far, there are no data that prospective evaluate clinical response parameters of this method and corresponding criteria for response. The investigators are therefore planning a prospective observational study on NOMI patients with the aim to collect 1. routine clinical data, 2. data from advanced angigraphic imaging and 3. data from blood biomarkers of intestinal ischemia before/at implementation of intra-arterial vasodilatory therapy. From these three data packages, the investigators hope to subsequentially derive criteria to better predict response to therapy.
The purpose is to observe and evaluate the safety and efficacy of Bingo drug-coated balloon in the real world.
Referral of infants to the respiratory sleep disorders breathing team with apnoeas [pauses in their breathing] and apparent life-threatening episodes are frequent. While the majority of such episodes do not have a significant underlying problem a potentially life threatening condition accounts for a significant proportion of cases. In order to fully assess an infant, a full-scale overnight polysomnography study would be required. Unfortunately due to the complexity of such studies and because the equipment is generally fully booked for many weeks ahead it is extremely difficult to arrange timely assessment. Hence, currently, we are largely reliant on simple screening with pulse oximetry (measuring oxygen levels in the blood with a simple probe). This is able to identify potentially significant problems, but it is does not help to determine whether this is because the baby simply stops breathing for a period due to disturbance of its control of breathing, or whether it is experiencing obstructive episodes, for which there are a number of causes. This new equipment to be assessed would potentially provide a simple, robust means of undertaking definitive studies simply and effectively on the medical wards with assessment of chest and abdominal wall movement being linked to pulse oximetry. This is likely to provide a substantial and significant improvement on our current practice. The benefits will be that, for those with no significant underlying problems, we will be able to provide much greater reassurance for the parents, which is clearly very valuable, while in those with a problem we will be able to distinguish those with central or obstructive apnoea with a degree of certainty that will greatly streamline further assessments and treatment.
This randomized controlled trial will evaluate a web-based relapse management programme, which is easily accessible for people with multiple sclerosis. The trial is accompanied by a mixed-methods process evaluation and a health economic evaluation. It is expected that the programme will positively change patients' relapse management and strengthen their autonomy and participation.
The primary objective for Part A of the study is to assess the pharmacokinetics (PK) of evinacumab in pediatric patients with homozygous familial hypercholesterolemia (HoFH). The primary objective for Part B of the study is to demonstrate a reduction of low-density lipoprotein cholesterol (LDL-C) by evinacumab in pediatric (5 to 11 years of age) patients with HoFH. The secondary objective for Part A of the study is to evaluate the safety and tolerability of evinacumab administered intravenous (IV) in pediatric patients with HoFH. The secondary objectives for Part B of the study are: - To evaluate the effect of evinacumab on other lipid parameters (ie, apolipoprotein B (Apo B), non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol (TC), lipoprotein a [Lp(a)]) in pediatric patients with HoFH - To evaluate the safety and tolerability of evinacumab administered IV in pediatric patients with HoFH - To assess the PK of evinacumab in pediatric patients with HoFH - To assess the immunogenicity of evinacumab in pediatric patients with HoFH over time - To evaluate patient efficacy by mutation status
The investigators will evaluate the change of the common carotid artery blood flow according to patient's position and penumoperitoneum.