Daegu City, Korea, Republic of

Retrospective Assessment of Referral of a Major Trauma Patient

In France, the number of major trauma is estimated at between 15,000 and 20,000 per year. It is the leading cause of death in patients under the age of 40, and is a significant source of long-term dependency. Mortality from severe trauma varies depending on the region and the circumstances of the accident. Effective initial care and referral to specialist trauma centres are crucial to improving survival. Access to these centres must be guaranteed throughout France. Trauma centres play a central role in the management of serious trauma patients. They are classified by level, from level I to level III. The triage process aims to direct the patient to the trauma centre with the appropriate level of care. The challenge is to send the "right patient to the right place at the right time". Over-triage and under-triage are two critical concepts in the management of trauma patients. Over-triage (patients considered to be more seriously injured than they really are) leads to excessive consumption of resources and increases waiting times for patients who really need a level I or II trauma centre. Under-triage (patients considered to be less seriously injured than they really are), is characterised by patients being referred to a trauma centre that is insufficiently equipped for their needs, compromises their chances of survival and recovery. In both cases, the loss of chance for the patient is real. The aim of this study is to find out whether major trauma patients from the Val d'Oise are referred to the appropriate trauma centre for their care, and to assess the quality of triage within the Val d'Oise department.

Assessment of HGI (Hemoglobin Glycation Index) Variability Over Time in Patients Living with Diabetes Using Continuous Glucose Monitoring ( GAP OUEST )

Reason for Prescribing Rice Infant Formula

The main purpose of this study is to describe the pattern of RIF consumption in real life conditions, whatever the reasons of initiation and the chosen formula. The main objective is to study the reasons for prescribing a RIF during the first year of life, as per the pediatrician. Consumption started before 6 months of age, when milk and infantile formulas predominates in the baby's feeding, is of particular interest. Secondary objectives are to describe the modalities of feeding before, during and after consuming the RIF, to describe the growth of children who have consumed a RIF for at least 1 month, on the basis of anthropometric data collected during the first year of life. As a second intention, this study also aims to monitor the evolution of child's digestive and allergic symptoms, if any, and the sociodemographic characteristics of the infant's family.

A Study to Assess and Compare Safety and Tolerability of 3 Months Treatment With Salbutamol Administered Via MDI Containing Propellant HFA-152a or HFA-134a in Participants ≥ 18 Years of Age With Asthma

Assessment of the Impact of the Return Home of Premature Newborns Less Than 2 Kilos Morbidity/Mortality

Prematurity in itself, whether simple or associated with intrauterine growth retardation, continues to be a real public health problem. In addition to gestational age at birth, the presence of co-morbidities can affect the morbidity and mortality of premature babies, as well as the length of hospital stay. Advances in neonatal care and the involvement and skills of parents in the care of premature infants have led to a considerable reduction in mortality among these patients. According to the latest recommendations published in November 2022 by the WHO, and thanks to changes in the criteria for discharging these patients in recent years, the same applies to low-birthweight infants. The early and well-planned discharge of premature babies is currently the subject of a great deal of study and research. According to these studies, it has been shown that the essential criteria for this discharge are the physiological capacities and skills of these vulnerable patients (thermoregulation, autonomous feeding and breathing, etc.). Essential care, parental support and home visits by qualified health workers (PMI, HAD, etc.) are also essential. Premature birth has a real impact on the economic consequences in several countries. Infants small for gestational age had longer hospital stays, were more likely to be admitted to an intensive care unit and were more likely to be hospitalised in the first year of life, resulting in higher costs. It is against this backdrop that the NOVO hospital is proposing to evaluate the impact of discharging babies weighing less than 2 kilos. To do this, the investigator will base his study on the short-term and long-term outcome of newborns weighing less than 2 kilos who were discharged from the NOVO hospital's neonatology department between 2012 and 2024.

Pembrolizumab and Chemotherapy Treatment or no Treatment Guided by the Level of TILs in Resected Early-stage TNBC

(Neo)adjuvant chemotherapy in breast cancer is associated to long-term persistent QoL deterioration in patients with early breast cancer, with a greater negative impact in patients that were premenopausal at diagnosis. Because triple negative breast cancer (TNBC), which accounts for 10-20% of breast cancers, presents a poorer prognosis as compared to the other subtypes, international guidelines endorse the use of adjuvant chemotherapy from TNBC tumors measuring > 5 mm. Nevertheless, a number of retrospective studies have reported excellent prognosis for patients with small, lymph node-negative and high TILs TNBC, even without chemotherapy, with 5-year overall survival (OS) of 98%. Findings from multiple data sets consistently demonstrated that TILs represent a robust prognostic and predictive biomarker in early-stage TNBC, being now the first biological prognostic marker for TNBC included in several international guidelines for early-stage disease, such as 2019 St Gallen consensus conference and European Society for Medical Oncology (ESMO) Guidelines for early-stage breast cancer. In clinical practice, oncologists have taken different approaches in patients with stage I TNBC. While some have de-escalated anthracyclines, other did not held back on the standard chemotherapy options with anthracyclines, taxanes, and cyclophosphamide. Based on unpublished data from the TNBC pooled analysis with sTILs on 2211 patients not treated by systematic therapy, performed at Gustave Roussy, the 5-year distant disease free-survival (DDFS) is 87%, 91%, and 93% for those with stage I and sTILs ≥ 30%, 50%, and 75%, respectively. Given these compelling findings from historical observations, it is reasonable to anticipate that the absolute benefit of chemotherapy would be modest among these patients as their tumors generally exhibit a favorable prognosis, resulting in reduced benefits with the use of adjuvant chemotherapy. ETNA is a phase II, multicenter, biomarker-driven study that is designed to characterize the clinical course of patients with stage I TNBC and sTILs ≥ 30%. ETNA includes patients with stage I and sTILs ≥ 30% TNBC in 2 cohorts: - Cohort 1 will include patients age > 40 years with 30% ≤ sTILs < 50% and those aged ≤ 40 years with 30% ≤ sTILs < 75%. Patients will receive 9 cycles of adjuvant pembrolizumab 200 mg every three weeks for 9 cycles and Paclitaxel 80 mg/m² weekly for 12 cycles. - Cohort 2 will include patients aged > 40 years with sTILs ≥ 50% and those aged ≤ 40 years with sTILs ≥ 75% who will undergo standard surveillance (no adjuvant systemic treatments).

Analysis of Effectiveness and Safety of Teclistamab in Relapsed and Refractory Multiple Myeloma Patients

Onlay Synthetic Bioabsorbable Mesh Herniorrhaphy Versus Herniorrhaphy Only in the Primary Treatment of Large Hiatal Hernia

The large hiatal hernia (LHH) now represents approximately 50% of laparoscopic antireflux surgical practice. Aging of the population and improvement of perioperative management may suggest that the number of these interventions will increase in the next few years. However, recurrence is common and has been described in up to 30% of patients who have undergone laparoscopic repair after a median follow up of 24 months. The use of mesh reinforcement has been suggested to help preventing recurrence after LHH repair with non-absorbable and absorbable mesh. In a non-comparative retrospective study of 399 patients operated for LHH with onlay patch of a bioprosthetic absorbable (Gore® Bio-A® HH0710) mesh with a mean follow-up of 44 months, 16% had a symptomatic recurrence with 7,9% requiring reoperation, one patient had oesophageal stenosis. No comparative effectiveness data exist to date. Hypothesis: the incidence of postoperative hiatus hernia would be reduced by the addition of biosynthetic absorbable mesh reinforcement to a standardized suture repair technique, as compared to laparoscopic repair without mesh, without increasing the risk of complications. The main objective is to compare the radiologic recurrence rate at 2 years between standardized herniorrhaphy with onlay biosynthetic absorbable mesh repair versus standardized herniorrhaphy with no mesh in symptomatic LHH. The secondary objectives are : - To compare the improvement of specific symptoms between two arms; - To compare the Quality of life; - To compare the complication rate and thecomplication severity according to the Clavien-Dindo classification; - To assess the cost-effectiveness of standardized herniorrhaphy with onlay biosynthetic absorbable mesh repair as compared to standardized herniorrhaphy with no mesh, in symptomatic LHH, at 2 years, from the French Healthcare system point of view. The expected benefits are : - for the patient the diminution of LHH recurrence rate, quality of life improvement - for Public health: - Reducing the rate of reoperation for LHH; - Reduction of healthcare costs due to a decrease in proton pump consumption and surgical re-interventions; - The use of a synthetic bioprosthesis in laparoscopic surgery could be largely recommended and reimbursed either through the tariff related to the hospital stay (DRG tariff) or in additionto this tariff; - Long term follow-up up to 5 years, could be obtained thanks to the use of French health insurance databases.

Efficacy of Cotrimoxazole as a De-escalation Treatment of Ventilator-Associated Pneumonia in Intensive Care Unit

Multicentre randomized non-inferiority trial comparing cotrimoxazole to standard antibiotic therapy for enterobacterial VAP. Selection of patients will be done by physicians in ICU. All clinically suspected VAP will be confirmed with a lung sample (preferably bronchoalveolar lavage or protected distal specimen, otherwise endotracheal aspiration). Patients with a microbiologically confirmed VAP due to an Enterobacteriaceae susceptible to cotrimoxazole and at least one antibiotic of the empiric antibiotic therapy (based on international recommendations) will be included. After written informed consent, they will be randomized (1:1), using a computer-generated randomization scheme of various-sized blocks, stratified by presence of septic shock at VAP diagnosis and by presence of COVID-19 pneumonia on ICU admission, through a centralized 24 hours internet service (CleanWEB™) to cotrimoxazole, or best standard of care (either a beta-lactam or a fluoroquinolone), after randomization for a total duration of 7 days (including empiric initial appropriate treatment). Posology and modalities of antibiotic administration will be optimized based on most recent recommendations for ICU patients. Because antibiotic therapy will be variable in the control group, single or double blind is not appropriate. Daily follow-up until death or ICU discharge or day 28 will be performed (vital status, antibiotic therapy, new infection, Clostridium-difficile infection). Clinical (arterial blood gas, temperature, haematology, tracheal secretions) and radiological cure (chest X-ray) will be assessed at Day 7. Systematic MDR bacteria screening will be performed weekly and at ICU discharge. Vital status will be assessed at day 90. Alive patients leaving ICU before 90 days will be contacted by phone (if discharge at home) or by interview at hospital (if transferred in a different ward). Assessment of the clinical and radiological cure by an independent committee (1 specialist in infectious disease and 1 intensivist), blinded of the randomization arm (PROBE methodology).

Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia

Multicentre, prospective, open-label randomized controlled superiority trial with stratification on the presence of neurological symptoms at inclusion and on the presence/absence of risk factors for central pontine myelinolysis (chronic alcohol abuse, malnutrition, serum potassium < 3.0 mmol/L). Patients in ICU with severe hyponatremia defined by SNa < 115 mmol/L or SNa < 120 mmol/L in the presence of neurological symptoms (convulsions, stupor defined by a Glasgow score <12 or signs of brain herniation) and a normal or decreased extracellular fluid volume will be included. After written informed consent, they will be randomized (1:1), using a computer-generated randomization scheme of various-sized blocks, stratified by the presence of neurological symptoms at inclusion (seizures, stupor defined as Glasgow score <12 or signs of brain herniation) and on the presence/absence of risk factors for central pontine myelinolysis (chronic alcohol abuse [defined according to World Health Organization definition], malnutrition [BMI<20.5 or weight loss >5% in 3 months], serum potassium < 3.0 mmol/L), through a centralized 24-hour Internet service (CleanWEB™), to receive standard hyponatremic treatment alone or standard hyponatremic treatment and DDAVP 4 μg/ml IV, after randomisation and for a total duration of 48 hours. Since administration of DDAVP leads to an important decrease in urine output and increase in urine osmolarity which are clinically obvious very rapidly, a single or double blind trial is not appropriate. However, all investigators will be unaware of aggregate outcomes during the study and brain MRI imaging will be performed and analyzed blinded to the randomization group