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 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 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 apps 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 apps 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. Childrens 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 childs 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 interventions 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, 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.

This research aims to evaluate if the WE BEAT program, a 5-week online group-based wellbeing and skill-building program, helps teens aged 12 to 17 with moderate to severe congenital heart disease CHD improve their ability to handle stress and become more resilient. The study compares participants who receive the WE BEAT program to those who receive usual care, looking at resilience and quality of life. It also explores connections between self-reported psychosocial data and clinical outcomes. Participants will be randomly assigned to either the WE BEAT telemedicine intervention or usual care. After completing the 5-week program, those in the intervention group will be further randomized to either receive a single booster session at week 18 or no booster session. The booster session reviews all skills introduced in the program. The study lasts about 6 months for all participants. During the study, participants complete four sets of online surveys and provide three hair or saliva samples at different times. Some may also give optional blood and urine samples. Researchers will measure resilience using the Connor-Davidson Resilience Scale and assess various psychosocial and biological markers related to stress and wellbeing. Safety and participant experience are monitored throughout the study period.

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.