Real World Study

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 3:1 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.

Researchers are evaluating the efficacy and safety of biological agents in patients with allergic bronchopulmonary aspergillosis (ABPA), a condition that often affects people with severe bronchial asthma. The study follows guidelines from ISHAM for ABPA diagnosis and treatment, aiming to understand how biologics can impact this condition. This is a prospective, multicenter observational cohort study sponsored by Qianfoshan Hospital. Participants receive standard medical treatment consisting of oral prednisone with a tapering dose over several weeks, with or without oral voriconazole. Some patients also receive biological agents combined with this standard therapy for at least four months, following GINA2025 guidelines. The biologics are given alongside existing asthma treatments, such as inhaled corticosteroids and long-acting beta-agonists. The study compares groups receiving biologics plus standard treatment versus standard treatment alone. During the study, researchers monitor participants for one to two years, assessing the number of exacerbations, hospitalizations, time to first exacerbation, remission rates, glucocorticoid use, asthma control, and various immune markers such as serum IgE and eosinophil counts. Safety and overall mortality are also tracked. This extensive follow-up includes measuring treatment responses at eight weeks and ongoing assessments to evaluate long-term effects and disease control.

Researchers are evaluating a digital health intervention using a mobile application called "Pust Deg Bedre" (PDB) to support self-management in patients with Chronic Obstructive Pulmonary Disease (COPD). COPD patients often experience symptoms like dyspnea, cough, and chronic mucus hypersecretion, which increase infection risks and exacerbate the disease. This study aims to explore the feasibility, patient and physiotherapist experiences, and implementation of the PDB app in managing these symptoms. The intervention involves physiotherapists providing patients with training on how to use the PDB app, which offers tailored breathing and airway clearance techniques based on clinical assessment. Patients will engage with the app's treatment plan over an 8-week period, with follow-up at 6 months. Adjustments to the treatment plan may be made during the intervention. The study includes qualitative interviews and video-recorded physiotherapy sessions to gain deeper insights into the interactions and experiences of patients and physiotherapists. Participants will be assessed through questionnaires and interviews at the end of the 8-week treatment and at the 6-month follow-up. Researchers will collect both quantitative and qualitative data, including health-related outcomes, adherence, adverse events, and patient satisfaction. Physiotherapists will also be followed up to explore the impact of participation on their clinical practice. The total study duration includes the initial intervention and a long-term follow-up, aiming to gather comprehensive information on the app's usefulness and acceptability.

Researchers are evaluating a 12-week home-based mobile health (mHealth) intervention called the Shining Star study, aimed at improving adherence to the 24-Hour Movement Guidelines among preschool-aged children (3-4 years old) who currently meet zero or one of the guidelines for physical activity, screen time, and sleep. The trial seeks to determine if the intervention increases the number of children meeting all three guidelines and if the program is feasible for parents to implement. This randomized controlled trial compares an intervention group using the app to a waitlist control group. Participants in the intervention group will use the Shining Star mobile app, which delivers weekly lessons and behavior-related goals through concise messages, gamification features, behavior trackers, and a parent forum. The control group will receive no intervention during the initial 12 weeks but will complete the same assessments as the intervention group. After 12 weeks, control group participants will gain access to the app and resources. Physical activity and sleep will be tracked with accelerometers, and parents will complete questionnaires. Children's physical activity, sedentary behavior, and sleep patterns will be assessed at baseline, 6 weeks, and 12 weeks using accelerometers. Parents will provide feedback on their child's movement behaviors, development, and app usability through questionnaires and weekly surveys. Additional measures include motor skills tests, cognition assessments, behavioral problems, executive function, and BMI. Data will be securely stored and analyzed to evaluate the intervention's impact and app feasibility over the 12-week period.

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, and pharmacodynamics of a single dose of BW-50218 in healthy Chinese adults. This Phase 1 study aims to understand how this drug behaves in the body and its effects, involving participants aged 18 to 60 years who are generally healthy. Participants will receive one of several single doses of BW-50218 injection or a saline placebo. The study uses a randomized, double-blind design to compare different doses of BW-50218 against placebo. Each participant will receive only one dose, and the effects will be monitored over time. During the study, researchers will conduct various assessments including blood tests for hematology and chemistry, urinalysis, vital signs, ECGs, and physical exams from baseline to Day 360 after dosing. They will track adverse events and measure drug levels in plasma and urine up to Day 8. Participants will be closely monitored throughout the study duration, which lasts about one year, to evaluate the drug’s safety and how the body processes it.

Researchers are studying the WE BEAT program, a 5-week online group-based wellbeing and skill-building program designed for adolescents aged 12 to 17 with moderate to severe congenital heart disease (CHD). The trial aims to see if this program helps participants become more resilient and improves their quality of life compared to usual care. It also examines potential links between participant-reported psychosocial data and clinical outcomes related to CHD. Participants will be randomly assigned to either the WE BEAT program or usual care. After completing the 5-week program, those in the intervention group will be further randomized to receive either a single booster session at week 18 or no booster session. The booster session reviews all skills introduced in the original program. The usual care group will continue their standard treatment without the WE BEAT program. Throughout the approximately 6-month study, all participants will complete four online surveys and provide hair and saliva samples at multiple timepoints. Some may also volunteer for optional blood and urine samples. Researchers will measure resilience using the Connor-Davidson Resilience Scale and assess various psychosocial and biological markers of stress and wellbeing. The study includes ongoing data collection at baseline, week 5, week 18, and week 30 to track outcomes and safety.

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 AN01, a selective small-molecule dual inhibitor of phosphodiesterase 3 and 4 (PDE3/4), 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.