Observational Study

This observational study focuses on children under 18 years of age with tracheostomies who are followed at the Long-Term Intensive Care Unit LIVA at Karolinska University Hospital in Sweden. It aims to determine how often tracheostomy-related airway complications are asymptomatic or linked to symptoms detected through surveillance airway endoscopy. Additionally, the study evaluates how accurately caregivers and pediatricians can identify symptoms related to serious airway complications. Children scheduled for regular surveillance airway endoscopy under anesthesia as part of their follow-up at LIVA will be included. Upon admission, caregivers complete a questionnaire about possible symptoms of airway complications. The child then undergoes a physical exam and medical history review by a pediatrician following a set protocol. An ENT surgeon, unaware of the questionnaire and pediatrician exam results, performs the airway endoscopy to identify complications. During the study, researchers will compare caregiver and pediatrician reports with findings from airway endoscopy to assess symptom reliability. The main measurements include the proportion of patients with serious tracheostomy airway complications who show no symptoms before endoscopy. The study spans two years, with ongoing surveillance and the collection of data on symptoms and complications. Ethical approval has been obtained to conduct this research.

Researchers are conducting a Phase I clinical trial to evaluate the safety, tolerability, and pharmacokinetic profile of AK0610 in healthy Chinese adults aged 18 to 50. The study is randomized, double-blind, and placebo-controlled, focusing on single-dose administration with dose escalation and expansion phases. The trial involves healthy volunteers to understand how the body processes AK0610 and to monitor any side effects. The trial has two parts a dose-escalation phase with five cohorts receiving increasing doses of AK0610 or placebo either intramuscularly or intravenously, and an expansion phase with two additional cohorts based on pharmacokinetic data. Doses range from 100 mg to 3000 mg, administered once on Day 1. Participants receive either AK0610 or placebo in a 31 ratio in all cohorts. Participants undergo a screening period from Day -29 to Day -1, followed by the dosing on Day 1 and an inpatient observation period until Day 8. Afterward, there is a blinded follow-up period lasting until Day 181, with those receiving AK0610 entering an open-label period from Day 182 to Day 361. Researchers will monitor adverse events, measure serum drug concentrations, and assess immunogenicity and RSV-neutralizing activity throughout the study.

Prostate cancer is the most common cancer among men in Denmark, often developing slowly without symptoms. This trial evaluates a complex intervention designed to improve how general practitioners GPs use prostate specific antigen PSA tests in line with national guidelines. The goal is to reduce overdiagnosis and overtreatment caused by unnecessary PSA testing, by promoting evidence-based practice among GPs in quality clusters. The intervention involves a cluster package including a pre-recorded podcast for GPs, a two-hour cluster meeting with educational material and group discussions, and two sets of hand-outs to support GPs in their clinics. Quality clusters are randomized to either receive this intervention over six months or act as a control group, which will be offered the intervention afterward. Participants, who are quality clusters of GPs, will be involved in cluster meetings and use the provided materials. Researchers will measure changes in PSA testing frequency among men during the six-month intervention period, as well as variations between GPs. The study includes assessments of PSA test use before and after the intervention to evaluate its impact on clinical practice.

This prospective, multicenter, observational cohort study focuses on patients with allergic bronchopulmonary aspergillosis. The aim is to evaluate the efficacy and safety of biological agents used in these patients across multiple participating centers. The study observes how biological agents perform in the treatment of allergic bronchopulmonary aspergillosis while also assessing their safety.

Researchers are investigating the long-term effects of a multidomain program that includes physical activity, choir singing, learning, and horticulture on preventing cognitive decline in older adults who show signs of frailty. The study aims to see if engaging in these varied activities, especially music, can slow down cognitive and perceptual decline, encourage positive brain changes during aging, and reduce loneliness by promoting social interaction. Participants will be community-dwelling elderly individuals aged 65 and older. Participants will be randomly assigned to one of three groups one that takes part in the multidomain intervention including choir and other activities, an active control group that engages in several activities excluding music, and a passive control group that does little or sporadic activity. The program lasts for nine months, during which participants regularly attend their assigned activities. Researchers will collect saliva samples and perform various assessments before and after the program, as well as six months later. Throughout the study, participants will be tested three times to measure brain-derived neurotrophic factor BDNF levels, cognitive abilities, hearing function, frailty status, and psychosocial well-being. They will also keep weekly diaries to track the time spent on activities. The study includes detailed evaluations such as neuropsychological tests, audiometric exams, and brain response measurements to understand how these interventions impact brain health and overall function over time. The total study duration for each participant covers the nine-month intervention plus a six-month follow-up.

Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and early clinical effects of CND319 in healthy adults and patients with rheumatic diseases such as rheumatoid arthritis and Sjogrens syndrome. This Phase 1, first-in-human study consists of two parts a dose escalation phase and an open-label expansion, aiming to better understand how CND319 behaves in the body and its initial impact on these conditions. Participants will receive CND319 according to the dosing schedule assigned to their cohort. The study includes single ascending dose SAD and multiple ascending dose MAD parts, with the open-label expansion providing further evaluation. The dose escalation part assesses increasing doses to understand safety and drug behavior, while the expansion phase allows additional participants to receive the drug openly. During the study, participants will be closely monitored through various assessments including vital signs body temperature, heart rate, respiratory rate, blood pressure, pulse oximetry, ECG parameters, and laboratory safety tests from baseline through up to 12 weeks for SAD or 24 weeks for MAD and open-label parts. Researchers will also track the presence of anti-drug antibodies and pharmacokinetic measures such as drug concentration and clearance. Total participation duration depends on the study part but may last up to 24 weeks.

Acute Respiratory Distress Syndrome ARDS is a sudden and severe lung injury that leads to acute respiratory failure, affecting around 3 million people worldwide each year and accounting for about 10% of intensive care unit admissions. Because there are no specific drug treatments available, mechanical ventilation is the main method used to support patients. This study aims to identify and analyze factors that predict outcomes for patients with ARDS to help improve their prognosis and reduce poor outcomes. This is an observational study where patients with ARDS or at high risk for ARDS are monitored without any investigational treatment intervention. The study observes various clinical measures daily, including chest CT scans, complete blood counts, arterial blood gases, and records fluid balance and mechanical ventilation data continuously after intubation. The study collects detailed health data to better understand ARDS progression and outcomes. Participants will be closely monitored through daily scans, blood tests, and respiratory assessments after enrollment. The main outcomes being measured are mortality rates at 28 and 60 days after diagnosis of ARDS. Monitoring includes continuous mechanical ventilation data and fluid balance whenever changes occur. The study involves informed consent and follows patients during their critical illness to gather real-world information on respiratory failure outcomes.

Researchers are evaluating the safety, tolerability, and how the body processes the drug ZP6590 in adult men who are healthy and have a normal weight, are overweight, or have obesity. This randomized, double-blind, placebo-controlled trial aims to understand if ZP6590 is safe and well tolerated when given as increasing single and multiple doses. The study also investigates how quickly and to what extent the drug is absorbed, distributed, and eliminated from the body. The trial has two parts. In the first part, participants receive a single subcutaneous dose of ZP6590 or placebo followed by a 4-week observation period. In the second part, participants receive multiple subcutaneous doses of ZP6590 or placebo for either 6 or 12 weeks, followed by a 6-week observation period after the last dose. Participants are admitted to the study site before dosing and may have ambulatory visits or stay under in-house conditions after dosing. Safety and drug exposure are evaluated before increasing to the next dose level. Participants will undergo screening to confirm eligibility before enrollment. During the study, safety assessments, blood tests, and pharmacokinetic evaluations are performed regularly to monitor the drugs effects and how it is processed in the body. The main outcomes measured are safety and tolerability over the dosing and observation periods. Participants involvement lasts up to 18 weeks depending on the dosing schedule, including observation periods following dosing.

Researchers are studying the safety and effects of a new medicine called PF-08103402 in healthy adults and adults with mild-to-moderate asthma. This Phase 1 trial aims to understand how the body processes this medicine, how much reaches the bloodstream, how food and other medicines affect it, and how the medicine leaves the body. The study includes healthy volunteers and adults diagnosed with asthma, evaluating different doses and formulations. The study has six parts named A through F. Participants take PF-08103402 as an oral suspension or tablet once daily, with some parts requiring 14 days of dosing and others a single dose. There are optional groups for Japanese participants and adults with asthma. Some parts also test the medicine with other drugs like midazolam. The length of participation varies by study part, ranging from about 9 to 16 weeks. Participants will visit the study clinic multiple times and have overnight stays ranging from 10 to 28 nights depending on the part. They will undergo examinations including physical checks, heart tests ECG, blood and urine tests, breathing tests for asthma patients, stool samples, vital signs monitoring, and questionnaires. The study team will also call participants at the end of the study to assess their health. Researchers will measure safety outcomes like adverse events and how the medicine behaves in the body.

Researchers are evaluating AN01, a selective small-molecule dual inhibitor of phosphodiesterase 3 and 4 PDE34, as a potential new therapy for chronic obstructive pulmonary disease COPD. This study focuses on assessing the safety, tolerability, and how the body processes multiple doses of AN01 in healthy adult participants. The trial is designed as a phase 1 study and sponsored by AirNexis Therapeutics, Inc. The study includes three multiple ascending dose MAD groups where participants are randomly assigned to receive either placebo or increasing doses of AN01 in a double-blinded manner. An additional dose group may be added by the sponsor if needed. Treatments are given as inhalation powder, with the dosing period lasting up to 14 days. Participants will undergo various health assessments including physical exams, vital signs, laboratory tests, lung function tests spirometry, respiratory assessments, and heart monitoring via 12-lead electrocardiogram ECG from day 1 through day 14. The study also collects blood samples to analyze how AN01 is absorbed, distributed, metabolized, and eliminated. Researchers will monitor for any side effects or abnormal results during and shortly after dosing to evaluate safety and tolerability.