Gumi-si, Korea, Republic of

Evaluation of the Inflammation-based Index as a Predictive Marker of Clinical and Radiological Response in Patients Treated With Lu-177 Oxodotreotide for Intestinal Neuroendocrine Tumour

Impact of Pain From Injectables Antiretroviral Treatments in HIV-1 Patients Based on the Injection Site (Ventrogluteal or Dorsogluteal) and the Use or Non-use of Virtual Reality Headset

Five visits will be performed as a standard of care: Inclusion visit: After checking of the eligibility, patient is informed of the study and an informed note is given. Injection site is examined. If the patient agrees, consent is collected. Visit D0 (all the patients): examination of the injection zone by the nurse, collection of concomitant treatments (only analgesics and anti-inflammatory drugs) taken by the patient, CAB+RPV injections according to the randomization arm, completion of the numerical scale by the patient following ARV injections, submission of the patient log for the assessment of pain by the patient during the 7 days following the ARV injections. Follow-up visits (M1, M3, M5 for naïve patients and M2, M4, M6 for treatment-experienced patients): recovery of the patient log with assessment of pain on previous injection, collection of concomitants treatments and adverse events, examination of the injection site by the nurse, injection according the randomization arm, completion of the numerical scale by the patient following the injections, delivery of a new patient note. End of study visit: recovery of the patient log with assessment of pain on previous injection, collection of concomitants treatments and adverse events, questioning the study procedures, patient's preferred choice between the different injection procedures. For the research needs, - The injection site (ventrogluteal and dorsogluteal) will be chosen, by randomisation - Wearing a virtual reality headset A patient log to assess pain, using a numerical scale (1 to 10), will be filled out by the patient

A Study to Learn About How Safe BAY 3389934 is, Its Suitable Dose, and How it Affects the Participants With Sepsis Induced Coagulopathy

Long-Term Evaluation of TAILORED Vs Anatomical Ablation Strategy for Persistent Atrial Fibrillation

The TAILORED-AF study demonstrated at one year's follow-up that a tailored ablation strategy guided by Volta Medical AI-software targeting areas of spatio-temporal dispersed electrograms in combination with pulmonary vein isolation (PVI) ablation is more effective to an anatomical ablation strategy targeting PVI alone (current standard of care) for the treatment of persistent atrial fibrillation (AF). VX1 legacy device renamed Volta AF-Xplorer was used in the TAILORED-AF study in the treatment arm. No additional treatments are specifically required in the scope of this ancillary TAILORED-LT study which aims to follow the patients previously treated in the initial TAILORED-AF study over the long-term. However, in the event of repeat procedures during the TAILORED-LT study, the choice of the ablation technique will be left to the investigator's discretion, regardless of the patient's randomization arm in the TAILORED-AF study. The annual follow-up will be performed as in routine clinical practice post AF ablation procedures: visits at 24 months, 36 months, 48 months and 60 months post TAILORED-AF Study index procedure. It is possible that some of these annual visits cannot be completed prospectively due to time already having elapsed between the end of the subject participation in the TAILORED-AF study and the date of enrollment in the extension TAILORED-LT study. In this case, available data (among those expected by the study protocol) will be collected retrospectively. The additional procedures related to this clinical investigation are limited to annual 24-hour Holters and to the administration of Quality Of Life questionnaires (SF-36 and AFEQT) to the patients during follow-up visits.

Prevention of Postpartum Venous Thromboembolism in Women at Intermediate Risk

Survey of Adult Participants Enrolled in Decentralized Clinical Trials

The purpose of this survey is to assess the interest of adults enrolled in a traditional interventional clinical trial involving a drug in participating in a clinical trial incorporating decentralized elements.

Prospective Study of the Methods and Outcomes of CHYME REinstillation After Small Bowel Surgery

The nutritional data and the quantification of digestive losses will be compared between the period preceding chyme reinfusion (CR) and the CR period using appropriate tests based on the quantitative or qualitative nature of the data. Other endpoints recorded after the start of CR will be analyzed using a descriptive and analytical methodology.

Evaluation of Blood and Cardiac Protein O-GlcNAcylation Levels in Cardiac Surgery in Children

Extracorporeal circulation (ECC) is a circuit that provides circulatory assistance to facilitate surgical access to a bloodless and, in some cases (in the case of cardioplegia) immobile operating field. This strategy has led to technical and procedural advances in cardiothoracic surgery that would have been unthinkable without bypass surgery. ECC leads to systemic inflammatory response syndrome and is associated with postoperative complications, including myocardial dysfunction, respiratory failure, acute renal failure, neurological dysfunction, coagulation disorders and, finally, multivisceral failure. Numerous data suggest that inflammation and oxidative stress occur shortly after the start of bypass surgery and progress over time. ECC-induced SIRS, similar to sepsis, leads to stimulation and activation of endothelial cells. Circulating pro-inflammatory cytokines can also directly stimulate endothelial cells, resulting in a pathological increase in permeability leading to the development of capillary leak syndrome, causing tissue oedema and impaired oxygen utilisation leading to multiple organ dysfunctions. Clinical practice has shown that the majority of infants suffer haemodynamic failure within 4 to 8 hours of the operation. This failure could be related to a state of vasodilatation (capillary leakage) and/or a low cardiac output syndrome. The timing of the onset of this failure correlates with peak cytokine secretion. The risk factors for severe SIRS in paediatric cardiac surgery are low weight, heart disease with an intra-cardiac right-left shunt, the duration of aortic clamping and the length of the bypass operation. This state of vasoplegia is associated with an increase in lactate production, reflecting an imbalance between organ oxygen demand and supply, an increase in amine requirements and an increase in invasive ventilation time. In many cases, vasoplegia is associated with low cardiac output syndrome. This syndrome is the most common post-operative complication in paediatric cardiac surgery. Twenty-five to sixty per cent of newborns develop low cardiac output syndrome (LCOS) in the 6 to 18 hours following surgery, with mortality occurring in 20% of cases. Current means of limiting post-CEC SIRS remain limited. The understanding of inflammatory processes and the interaction between humoral factors and the cellular immune response has progressed rapidly over the last decade. Multiple anti-inflammatory strategies have been applied in the past, significantly reducing cytokine levels without improving clinical outcome. This means that the amplitude of inflammatory cytokine secretion does not directly predict patient outcome. Future studies should aim to address new post-CEC prophylactic targets to improve myocardial and endothelial function. Cardiac metabolism is an important area of research because it plays a central role in maintaining cardiac function under stress. In recent years, there has been considerable interest in O-GlcNAcylation, a post-translational modification of proteins, as it plays a key role in regulating cellular metabolism and the ability to adapt to stress and cell survival. O-N-acetyl glucosaminylation, more simply known as O-GlcNAcylation, is a ubiquitous, rapid and reversible post-translational modification involving the addition of a monosaccharide: ß-D-N-acetylglucosamine to the serine and threonine residues of proteins. In physiological conditions, some of the glucose entering the cell is directed towards the hexosamine biosynthesis pathway (VBH), which leads to the production of UDP-GlcNAc, used by O-GlcNAc transferase (OGT) to O-GlcNAcylate proteins. The reverse reaction is catalysed by O-GlcNAcase (OGA). VBH is at the crossroads of several cellular metabolic pathways (glucose, acetyl-CoA, glutamine, uridine and ATP) and O-GlcNAcylation is considered to be a metabolic sensor. The number of O-GlcNAcylated targets (+3000 proteins) bears witness to the involvement of this modification in various cellular functions. O-GlcNAc levels are finely modulated according to the cell's metabolic environment, enabling it to adapt to stress. This last point is particularly important as metabolism changes during development and during CEC, which impacts the hexosamine biosynthesis pathway and therefore O-GlcNAcylation. O-GlcNAcylation is particularly difficult to study at cardiac level, but the investigators have shown that there is a close correlation between blood (whole blood) and cardiac O-GlcNAc levels in rats. Preliminary data in rats have shown that O-GlcNAcylation levels decrease during bypass surgery and that there is an interest in increasing O-GlcNAcylation levels during bypass surgery in order to reduce organ failure, but no human data have been published in this context.

Evaluation of Blood Protein O-GlcNAcylation Levels in Children

Sepsis is a major but potentially preventable cause of death in children worldwide, with a mortality rate of 29%. It also causes 28% of mild disability and 17% of severe disability in Europe. It is important to note that most studies only look at septic shock in adults, but the populations most affected by septic shock are young children and the elderly. An obvious difficulty in the diagnosis of septic shock in paediatrics is related to the variability of physiological values according to age and the specific pathophysiological features of this pathology in children. Septic shock should be suspected when the child presents with a change in mental status associated with infection and signs of tissue hypoperfusion. Unlike in adults, where septic shock is classically biphasic with an early phase of vasoplegia followed by a phase of low cardiac output, a specific haemodynamic profile is observed in children. It is characterised by severe hypovolemia requiring vascular filling with very heterogeneous responses, low cardiac output and high systemic arterial resistance. In children, septic shock is a dynamic process with heterogeneous haemodynamic phases that change during the course of the shock. The therapeutic agents used and their doses must therefore be adjusted at all times to maintain vascular perfusion. Between 2005 and 2011, more than half of paediatric deaths from septic shock occurred within the first 24 hours. Prompt treatment is a vital factor in the prognosis, with each additional hour spent in shock doubling the risk of death. Unlike in adults, low cardiac output, rather than increased systemic vascular resistance, is associated with mortality. Due to a higher basal heart rate, the increase in heart rate is more limited than in adults. Although the physiopathology of children is different (lower cardiac reserve, lower basal arterial pressure), there are no specific recommendations for children; those for adults are adapted to this population. On the basis of these alarming data, there is a significant socio-economic interest in identifying new treatments for the management of young patients. Cardiac metabolism is an important area of research because it plays a central role in maintaining cardiac function under stress. In recent years, O-N-acetyl-glucosaminylation, more simply known as O-GlcNAcylation, a post-translational modification of proteins, has attracted considerable interest because it plays a key role in regulating cellular metabolism, but also in the ability to adapt to stress and cell survival. Particular attention has been paid to this metabolic pathway in various pathologies (Alzheimer's disease - patent US20200079766, diabetes, heart attack, etc.) but always in adults or the elderly. The work that investigators have carried out shows that the levels of O-GlcNAcylation of cardiac proteins vary during the early stages of life in rats. This observation is crucial because it could explain some of the metabolic peculiarities of the young heart (use of mainly glycolytic substrates during the first days of life, for example) and the greater capacity of the hearts of newborn rats to withstand stress such as ischaemia-reperfusion. O-GlcNAcylation is a ubiquitous, rapid and reversible post-translational modification involving the addition of a monosaccharide: ß-D-N-acetylglucosamine to the serine and threonine residues of proteins. In physiological conditions, 2 to 3% of the glucose entering the cell is directed towards the hexosamine biosynthesis pathway (VBH), which leads to the production of UDP-GlcNAc used by O-GlcNAc transferase (OGT) to O-GlcNAcylate proteins. The reverse reaction is catalysed by O-GlcNAcase (OGA). VBH is at the crossroads of several cellular metabolic pathways (glucose, acetyl-CoA, glutamine, uridine and ATP) and O-GlcNAcylation is considered to be a metabolic sensor. The number of O-GlcNAcylated targets (+8000 proteins) bears witness to the involvement of this modification in various cellular functions. O-GlcNAc levels are finely modulated according to the cell's metabolic environment, enabling it to adapt to stress. This last point is particularly important as metabolism changes during development, and could have an impact on the hexosamine biosynthesis pathway and therefore on O-GlcNAcylation. Stimulation of O-GlcNAcylation has been shown to be beneficial in several acute pathologies and different animal models. It could therefore be interesting to use this approach in children to limit the impact of various pathologies that induce SIRS, such as extracorporeal circulation for major surgery, septic shock and various traumas.

DOVIPA, a Study Evaluating Efficacy and Safety of DOstarlimab and VItamin D3 with MFOLFIRINOX in PAncreatic Cancer