Epidemiological Study

Study Objective This observational study aims to prospectively investigate to what extent tracheostomy-related complications in children are asymptomatic or associated with symptoms when detected through surveillance airway endoscopy. We also aim at investigating how reliable caregiver reports and investigations by pediatriscians are in identifying symptoms associated with severe tracheostomy-related airway complications. Background Children with airway obstruction due to congenital malformations, trauma, or chronic respiratory or neuromuscular conditions may require a tracheostomy. The Long-Term Intensive Care Unit (LIVA), part of the Pediatric Perioperative Medicine and Intensive Care (BPMI) at Karolinska University Hospital, has been providing specialized care for children with tracheostomies across Sweden since 1998. The care at LIVA involves assessements by a multidisciplinary team, including pediatricians, ENT specialists, pediatric anesthesiologists, nurses, physiotherapists, dietitians, speech therapists, counselors, and play therapists. Follow-up at LIVA includes regular multidisciplinary assessments and one to two surveillance airway endoscopies under anesthesia annually, aimed at early detection of airway complications related to the tracheostomy tube. Complications such as granulomas, infections, or bleeding are often asymptomatic but can be potentially life-threatening. There is currently no national or international consensus on the optimal frequency of surveillance endoscopies, and the potential for individualizing surveillance based on risk factors, including the presentation of symptoms, remains unexplored. Given the risks associated with anesthesia, minimizing unnecessary procedures is critical. Currently, a retrospective study is underway to examine the incidence of tracheostomy-related complications, their correlation with risk and demographic factors, and preoperative symptoms. Preliminary results indicate that 72% of patients experienced at least one tracheostomy-related complication, while only 19% exhibited symptoms prior to surveillance endoscopy according to patient records. Suprastomal granuloma was the most frequent complication observed. Interventions were required for all symptomatic patients and 71% of asymptomatic patients with identified complications. Patients using ventilators and/or cuffed cannulas had a higher incidence of complications compared to those without (88% vs. 61%, p\<0.05). Study Population The study population comprises children under 18 years of age undergoing follow-up at the Long-Term Intensive Care Unit (LIVA) at Karolinska University Hospital in Stockholm, Sweden. Research Questions 1. To what extent are tracheostomy-related complications in children asymptomatic when detected through surveillance airway endoscopy? 2. How reliable are caregiver reports in identifying symptoms associated with tracheostomy-related airway complications? Methods Children scheduled for surveillance airway endoscopy are admitted to LIVA. Upon admission, the caregiver is asked to complete a short questionnaire regarding symptoms that may indicate a tracheostomy-related complication. After the questionnaire has been completed, the child will be examined by the responsible paediatrician, with the aim of identifying any signs or symptoms that could indicate an airway complication. The examination includes physical examination and medical history conducted according to a predefined protocol. The airway endoscopy is performed by an ENT surgeon who has not examined the patient beforehand and is not informed of the caregiver's responses nor the result of the examination by the pediatrician. However, there is no strict protocol in place to blind the surgeon to any visibly apparent symptoms or to information that may be spontaneously reported by the caregiver or paediatrician. Ethical Approval Ethical approval for the study has been obtained (Ref. No: 2023-07493-01).

Prostate cancer (PC) is the most common type of cancer among men in Denmark with an incidence of approximately 4.500 cases and 1.300 deaths every year. Usually prostate cancer develops very slowly and men with a detectable prostate tumor can live for many years without experiencing any symptoms. Autopsy studies of males who died of other causes finds PC in approximately 30 percent of males in their fifties and up to 70 percent of males in their seventies. From that perspective most men die with prostate cancer than because of it. In Denmark the first examinations of a possible prostate cancer diagnosis take place in general practice. Every citizen in Denmark with a social security number has free and direct access to a general practitioner (GP) and works as a gatekeeper to the healthcare system. If the GP suspects prostate cancer in a patient the GP has the possibility to measure the level of prostate specific antigen (PSA) in a blood sample. If the level of PSA is high it may indicate the presence of prostate cancer. However, according to the national clinical guidelines on detection and diagnostic investigation of prostate cancer the PSA-test is only recommended on a small patient group with very specific and rare symptoms. Furthermore they do not recommend neither systematic nor opportunistic screening with the PSA-test. The reason for the rather restrictive guidelines for PSA-testing is to avoid overdiagnosis and overtreatment of prostate cancer. A high level of PSA in a blood sample is not necessarily due to prostate cancer but could also be elevated by other conditions such as cystitis or an enlarged benign prostate. Even if the further examinations at a urology department in a hospital finds prostate cancer in the patient it is potentially indolent cancer and not a clinically important tumor which is an prostate cancer overdiagnosis and could lead to unnecessary treatment which is overtreatment. The treatment of prostate cancer could cause harms such as impotence, incontinence and faecal incontinence. Since 2018, GP's in Denmark has been encouraged to cluster in groups of other GP's from their local area to work with quality development and form so called quality clusters. The aim of these quality clusters was to create a medical professional forum where the GP's could meet 2-4 times a year and exchange experiences with each other in a specific clinically relevant area decided by the cluster itself. One of the main points of the quality cluster concept was that the quality development work should be based on descriptive data from their own GP clinics. At present 116 quality clusters exist in Denmark and includes 3.519 GP's in 1.542 GP clinics. By the same time of the establishment of the quality cluster a national organization called KiAP (a Danish acronym for Quality in General Practice) was founded. The primary purpose was to support the quality clusters with their quality development work. One of the supportive initiatives by KiAP is the development of cluster packages which is meeting material for the quality clusters on their cluster meetings. A cluster packages has one specific clinically relevant theme and consists of data, expert videos, reflection questions among other things. The investigators have chosen to develop a cluster package about PSA-tests in general practice with the purpose to promote an evidence-based practice. A pilot study will be conducted in the development process. The aim of the study is to evaluate the effectiveness of the cluster package. Since the study is a cluster randomized trial the investigators invited all the Danish quality clusters to agree to use the cluster package on one of their cluster meetings. The participating quality clusters are randomized to an intervention group and a control group.

Acute Respiratory Distress Syndrome (ARDS) is a form of acute diffuse lung injury caused by various etiologies, which rapidly progresses to acute respiratory failure. It is characterized by a sudden onset and severe clinical course. Globally, ARDS affects approximately 3 million individuals each year, accounting for about 10% of admissions to intensive care units (ICUs). Due to the lack of specific pharmacological therapies, mechanical ventilation remains the mainstay of treatment. Therefore, identifying and analyzing prognostic factors for ARDS patients is of great significance for improving patient outcomes and reducing the incidence of poor prognosis.

The primary purpose of this study is to assess the safety and tolerability of oral glovadalen (UCB0022) in healthy Caucasian, Japanese, and Chinese participants.

This study aims to build and apply an artificial intelligence (AI) model to assist doctors in predicting patient diagnoses and outcomes, such as survival or hospital stay length. Patients will be enrolled across the hospital, and real-time, multimodal health data-including lab results, vital signs, medical history, and imaging-from electronic health records will be used. The study will follow participants to evaluate the AI model's performance against standard practice. The goal is to improve the accuracy and speed of diagnoses and treatments, enhancing patient care. This prospective study tests the model in real-world hospital settings.

The intensive care units is of the main components of modern healthcare systems. Formally, its aim is to offer the critically ill health care fit to their needs; ensuring that this health care is appropriate, sustainable, ethical and respectful of their autonomy. Intensive medicine is a cross-sectional specialty that encompasses a broad spectrum of pathologies in their most severe condition, and specifically has as its foundation the practice of comprehensive care of the patient with organ dysfunction and susceptible to recovery. Although critically ill patients are a heterogeneous population, they have in common the need for a high level of care, often requiring the use of high technology, specific procedures for the support of organ dysfunction and the collaboration of other medical and surgical specialties for their management and treatment. Since their origins in the late 1950s, intensive care units have been adapting to the changes arising from the best scientific evidence. In the late 1990s and early 2000s, there were some successful clinical trials published that had tested alternative management strategies in the ICU. Mechanical ventilation is an intervention that defines the critical care specialty. Between 1970 and the 1990s, the management focused on normalizing arterial blood gas with aggressive mechanical ventilation. Over the ensuing decades, it became apparent that performing positive pressure ventilation worsened lung injury. The pivotal moment in the mechanical ventilation story would be the low versus high tidal volume trial. This trial shifted the focus away from normalizing gas exchange to reducing harm with mechanical ventilation. Further, it paved way for further trials testing ventilation interventions (PEEP strategy, prone position ventilation) and nonventilation interventions (neuromuscular blockade, corticosteroids, inhaled nitric oxide, extracorporeal gas exchange) in critically ill patients. That evidence-based intensive care medicine has undoubtedly had an influence on the outcome of critically ill patients, in general, and, particularly, of patients requiring mechanical ventilation. Temporal changes in mortality over the time have been scarcely reported for patients admitted to intensive care unit. Objective of this study is to estimate the changes over the time in several outcomes in the patients admitted to an 18-beds medical-surgical intensive care unit from 1991 (year of start of activity) to 2026

The AnovaOS™ Network Powered Patient Registry may be used to inform the development and conduct of clinical trials and observational studies designed to better understand, prevent, diagnose, treat, ameliorate or cure disease. The AnovaOS™ Network Powered Patient Registry may additionally be used to expedite identification and recruitment of participants for clinical trials of promising therapeutics and observational studies.

Method:APACHE is a prospective national multicentre (29) cohort including and following during 10 years patients with a first peripheral arthritis in the past year, attributing to a PsA according to the treating rheumatologist. 425 patients will be included during a 4 years period before the follow-up. Standardized visits are planned throughout the 10 years follow-up, permitting the collection of various data: * clinical data * Patients Reported Outcome * usual lab parameters * plasma, serum and urines * Baseline and one year RNA, DNA * peripheral X-Rays, Ultrasounds and MRI at different time points Those visits have non interventional character (no therapeutic decision will be taken) Those collected data will allow submissions of many research projects to the scientific committee of the cohort.

Study Description: This protocol is designed to collect human specimens, such as blood, mucosal secretions, skin swabs, skin biopsy, or body fluids to support medical research. These samples will be used by researchers in their work on the development of vaccines and monoclonal antibodies, to study the correlates of immunity related to infectious diseases and allergies, and in laboratory work related to the development and/or validation of immunological and other relevant assays. Standard phlebotomy and apheresis procedures will be utilized to safely obtain necessary quantities of blood and cells. Objectives: To obtain human biological specimens such as blood (via phlebotomy), plasma or peripheral blood mononuclear cells (PBMC) samples (via apheresis), mucosal secretions, skin swabs, body fluids, and skin biopsy to support medical research. Study Population: Children, ages 3-17 years and adults, ages 18 years and older. Protocol Plan: Participants, including healthy volunteers and patients with an infection or with an allergic or autoimmune condition who consent to participate in this study, will undergo standard medical procedures to obtain biological specimens. Samples may be collected at clinic visits by study staff, at outside laboratories or healthcare providers, or at home by the participant and shipped to the NIH by the participant. Study Duration: Individual participants may donate samples as often as permitted by their institution s guidelines. The IRB-approved protocol will remain open and undergo annual continuing review by the IRB. Endpoints: There are no specific endpoints in this study, as samples are collected for investigations conducted in research laboratories to address questions related to immunity and vaccine and monoclonal antibody development. Therefore, there is no analysis plan for this protocol. This protocol will be conducted in accordance with Good Clinical Practices for human research solely for the purpose of obtaining samples for research laboratories. Samples will be identified only by a participant identification number. Non-personally identifying information that will be linked to a participant ID only, such as demographic information, aspects of the medical history, laboratory parameters, recent immunizations or medications, genetic tests, and other medical information, may be provided to researchers if needed to support the objectives of the laboratory research.

Aims: The primary objective of the registry is to create an IBD physicians' network in Argentina that captures pragmatic and relevant information from IBD patients in terms of demographic, clinical and diagnostic aspects. The secondary objective includes safety aspects, including infections, and access to healthcare. The tertiary objective is related to treatment effectiveness. For the treatment effectiveness outcome, information about IBD complications as flares, need of hospitalization and surgery will be included. Structure of the registry: The administrative structure of the registry includes an executive committee with an administrative and organizational role which is coordinating with the GADECCU steering committee; a scientific committee that evaluates and coordinates scientific initiatives and promotes specific new strategic projects of interest and approves requests for access to centralized data for research projects. Also, a methodological and regulatory team that provides methodological support to the registry and ensures the regulatory aspects in each institution or region. RADECCU includes a group of technical programmers who develop and provide support to the web platform that allows researchers to register and follow their patients. Ethical aspects: The RADECCU registry was approved by the ethics committee of each participant center with a similar project model. Later, individual regulatory and data protection requirements were fulfilled according to all applicable local regulations and laws in each participant center and practice. According the requirements of local approval of each center (need for informed consent or not) the principal investigator or those delegated to the center as co-investigators will fully explains the objective of the registry to all potential participants and encourages their questions. All patients willing to participate in the registry are required to provide an oral or signed consent form (pending on each approval) authorizing release of their coded medical information anonymized to the central registry. To be included in the registry, every center must fulfill the ethical and regulatory conditions. Population: Any patient diagnosed with IBD defined by validated diagnostic criteria can be included into the registry. The criteria for IBD diagnosis were agreed with all the members of the Scientific Committee of the registry prior to the start of registration, and were based on previously published criteria for IBD diagnosis, including clinical, endoscopic, laboratory, and histopathological aspects, as well as small bowel imaging studies (Bernstein CN, et al. Inflamm Bowel Dis. 2010;16(1):112-24. doi: 10.1002/ibd.21048.). In order to ensure the inclusion of all IBD patients in Argentina, the executive committee invites all centers associated to GADECCU and involved in the management of IBD patients, regardless of the volume of patients they are in charge of, including both public and private centers. To reduce the possibility of selection bias, each participating physician from each center should aim to include all patients seen in their practice or clinic. Centers and physicians involved: Medical assistance to IBD patients in Argentina is mainly provided by several physicians in different institutions and IBD unit throughout the country. The goal of the registry is to include all IBD patients in Argentina and, consequently, all IBD centers and physicians involved in the care of affected patients. All physicians and centers that are part of GADECCU were invited to participate in the registry. In addition, an invitation campaign was carried out at local and national gastroenterology congresses and scientific meetings for physicians not yet linked to GADECCU so that they could get to know and participate in the registry through GADECCU. The participation in RADECCU is voluntary for both the physicians and the patient. From February-2023 an active promotion of the registry was carried out, resulting in a final incorporation of 65 centers and 138 professionals distributed throughout Argentina. Data collection and patient confidentiality: Prevalent and incident cases are included in the Registry by each physician. Once the patient is identified, the requested data is included in a web platform specifically designed for the purpose of the registry. The data is uploaded by the principal investigators of each participating center. The Scientific Committee of RADECCU agree in a prior consensus, on a compulsory common minimum dataset consisting of selected information according to the principles of relevance to ensure the collection of enough data for the clinical characterization of a single patient. RADECCU is a website with restricted access only to authorized users with a username and password assigned by the executive committee. Users can only view the identifying data of patients they have uploaded themselves, and those who can access the complete database will only have access to an anonymized version of it. The platform will provide data in a comprehensive manner with low cost of development. During all registration processes, the protection of the patient's identity and data is observed in accordance with the legal regulations in force under the National Law of Protection of Personal Data from Argentina 25.326 (Habeas Data), in accordance with the international legislation on registration of diseases and protection of personal and private data, according to the 18th World Medical Assembly of Helsinki (1964), when applicable. The right to non-participation in the registry is always respected without this implying in any case any type of discrimination, differential treatment or mistreatment towards the patient. The entire process regarding informed consent, patient evaluation, data entry, data sharing and other procedures of the registry were standardized in an operation procedure described in documents of the registry function, and is available to all researchers in the registry. Data monitoring: The structure of the registry was designed considering all the mandatory variables at the time of entry and during the follow-up to be full upload. In this way, data loss is ensured to be kept at a minimum. Data will be centrally monitored by the methodological team to guarantee a high level of quality for the information collected. Centers will be periodically contacted with ad hoc reports with queries on missing data, inconsistencies among variables collected and any duplicates for their resolution. Research projects: The mission of RADECCU is not limited to assuring quality healthcare for patients with IBD in Argentina but also to stimulate research projects that address high-priority issues in our region. The philosophy behind the registry takes to reflect the collaborative nature of the project and to encourage epidemiological research efforts in IBD in Argentina. Any researcher who is part of the RADECCU may propose a research project with local or national impact that will be evaluated by the Scientific Committee and, if relevant, will be approved for its development. The data contained in the registry will be used in the research project and, in this way, the performance of various epidemiological studies employing data from RADECCU will also be stimulated. Statistical analysis plan: This is an open-ended registry, and sample size is not based on statistical considerations. The main objective of the Registry is a descriptive analysis regarding demographic and clinical aspects, therapy, and safety issues at IBD diagnosis and during follow-up. Statistical analyses will be performed on clinical parameters such as demography, response to therapy and the main aspect of safety, included in the minimum dataset. Analyses may also be performed on other parameters included all the uploaded datasets.