Åbo, Finland

Digital Universal Parenting Program for Positive Parenting Behaviors

The study will use a single-arm study design.The participants will use the universal parenting program for 8-weeks. The intervention is a digital parent training program which focuses on positive parenting and encouraging to develop parenting skills that strengthen the relationships and communication with their children. The topics includes for example reinforcing child´s positive behavior, reducing conflict situations and planning situations advanced, managing daily transitions, and being present to child. The program includes 5 themes with recommended length of 1 week each. Each theme includes theory material, videos, examples, video practices and exercises. The program is fully digital and provided in a dynamic, web-based format. SMS and email reminders will be sent regularly during the program. Recruitment: All parents with a 3-year old child who is participating in annual health checkup in child health clinic are considered eligible to the study and are asked to participate if they fulfil inclusion criteria and do not meet the exclusion criteria.

CtDNA for Early Response Assessment in PCNSL Treated with 1st Line Curative Intent (NLG-PCNSL-01)

A First-in-human Study to Learn About the Safety of BAY 3547926 and How Well it Works in Participants With Advanced Liver Cancer

Virtual Pulmonary Rehabilitation Program for COPD Patients; a Pilot Study

The e-PURE study is an investigator initiated study, which aims to evaluate the feasibility, effectiveness, and long-term outcomes of a digital pulmonary rehabilitation program designed for patients with Chronic Obstructive Pulmonary Disease (COPD) in Southwest Finland. This pilot study assesses patient adherence, lung function, exercise capacity, quality of life, and the program's potential impact on healthcare utilization. COPD is a common disease, affecting mostly elderly, with significant impact on life expectancy and quality of life. Pulmonary rehabilitation (PR) is an essential intervention for COPD patients, known to enhance health-related quality of life and reduce symptoms like shortness of breath. Traditional PR programs are underutilized due to accessibility barriers, with less than 1% of COPD patients in Canada and 3.7% in the U.S. attending such programs. The COVID-19 pandemic exacerbated these challenges by halting in-person PR programs. Virtual PR offers a promising, non-inferior alternative. The e-PURE study responds to this need by rolling out a digital rehabilitation program developed by a multidisciplinary team of healthcare professionals. This is a single-arm observational pilot study enrolling up to 50 COPD patients. The rehabilitation program spans around 12 weeks, with follow-up assessments at 16 and 26 weeks post-enrolment. Patients undergo a tailored rehabilitation plan that includes individualized exercise routines, nutritional counselling, and smoking cessation support. Progress is reported through questionnaires and clinical evaluations such as the 6-minute walk test. The primary outcome measure is the improvement in distance during the 6-minute walk test after the program, compared to baseline. Secondary outcomes include patient satisfaction, changes in the St. George Respiratory Questionnaire, and healthcare resource utilization (hospital readmissions, emergency visits). The pilot study will identify whether a larger follow-up study is feasible, and indicate the number of patients to recruit.

Total-body Glucose Utilization in Obesity

The study consists of two separate parts: the dose escalation study and the part studying the effects of emotions and insulin on blood flow. All participants will first undergo a screening visit starting with signing an informed consent form. Then they will undergo a physical examination, are interviewed about their medical history. Finally, some routine laboratory tests are collected, and a 75 g oral glucose tolerance test is performed. The participants who are eligibile for the study will continue to the PET studies. The dose escalation study will be completed first. In this 8 participants will be studied once with Siemens Biovision Quadra PET/CT scanner. They will receive eight doses of oxygen-15 labelledradiowater (H2[15O]O) ranging from 25 to 700 MBq, with each dose repeated twice to evaluate repeatability of each dose. These participants will not undergo any further studies. For the other subjects, there will be two more PET study visits. On the first visit, the effects of emotions, evoked by short movie clips or cold exposure of one leg, on whole-body blood flow will studied with oxygen-15 labelled radiowater. Each participant will be studied 8 times in one session, with repeated H2[15O]O boluses of 400 MBq followed by 7.5 min dynamic PET scans with Siemens Biovision Quadra PET/CT scanner and a 5 min recovery and wash-out period. On the other visit the effects of insulin on circulation will be studied by performing a hyperinsulinemic, euglycemic clamp during the PET scan. During the clamp, fast-acting insulin (NovoRapid, NovoNordisk) is administered intravenously at a fixed rate (40 mU/m2 body surface area/min). Plasma glucose is monitored every 5-10 minutes, and 20 % glucose is administered at a varying rate to maintain euglycemia (5.0 mmol/L). At the scanner a fasting H2[15O]O PET/CT scan (400 MBq) will be performed first. After this, the hyperinsulinemic, euglycemic clamp is started, and the radiowater scans are repeated 10 minutes and 50 minutes into the insulin infusion. 60 minutes after the start of clamp, 100 MBq of glucose analogue tracer [18F]fluorodeoxyglucose is administered and a 50 min dynamic PET scan is started. After the scan, insulin infusion is discontinued and participants are monitored until plasma glucose levels are adequate for safe discharge. For a subgroup of participants, skeletal muscle microvascular bloodflow will also be assessed with contrast-enhanced ultrasound performed during fasting and 30 minutes after the start of clamp. The participants will be administered intravenous contrast agent, and after steady plasma concentration is reached (2.5 min), the contrast agent micro bubbles are destroyed with a high-intensity ultrasound signal, and the rate at which small arterioles are refilled is measured. Data will be analysed using in-house developed programs. Regions of interest will be drawn manually for peripheral tissues (skeletal muscle, visceral, brown and subcutaneous adipose tissue, liver, kidney, intestines) and using automated segmentation tools for the brain.

Clinical Study of HER-096 in Healthy Volunteer Subjects and Patients with Parkinson's Disease

This is a Phase Ib clinical study, in which safety, tolerability and pharmacokinetic profile of HER-096 will be investigated after a subcutaneously (s.c.) administered single dose in healthy volunteer subjects (HVS) in an open-labelled Part 1 and after multiple s.c. administered doses in patients with Parkinson´s disease (PD) in a randomised, placebo-controlled Part 2. In Part 2, two out of three patients will receive active HER-096 treatment and one out of three patients will receive a placebo solution. Novel biomarkers related to the treatment will be explored. The total study duration per subject is approximately 50 days in Part 1 and 100 days in Part 2 consisting of screening, treatment and safety follow-up periods. In total, 8-12 male or female HVS and 24-28 male or female PD patients will be enrolled in the study.

Sleep Quality and Sleep-disordered Breathing in Bypass Surgery Patients

Detailed Description: Our hypothesis is that sleep-related apneas are increasing following coronary artery bypass surgery, and sleep quality may deteriorate. We are attempting to determine the causes of these difficulties, which are caused by microemboli in the brain from the use of a heart-lung machine, brain infarction induced by major surgery, thoracic tissue trauma following surgery, or complications during perioperative care. The hypothesis is that postoperative outcomes and recovery are related if a patient is identified with sleep apnea before CABG surgery. A sleep polygraph is performed before surgery and again around six months after, as well as a transthoracic echo and laboratory tests. If a link between sleep quality and coronary bypass surgery can be established, the results can be employed in clinical practice. The total amount of patients operated on heart-lung machine is anticipated to be 70. The off-pump patient sample size is remarkably smaller, so data is collected and compared with the main sample population. The operation technique is decided when the patient is scheduled for operation. Emergency patients are excluded because pre-operative examinations cannot be performed. Other exclusion criteria are nighttime CPAP- treatment and other heart operations (for example valve surgery) during CABG. Basic information including age, weight, height, diseases, medications, and medical history are collected from all patients. ECG is registered before and after surgery and sinus or other heart rhythms are recorded. Sleep polygraph is done preoperatively and postoperatively when the patient is fully recovered from surgery (at 6 months or more).

A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC in Adults With Ocular Myasthenia Gravis

A Study on the Immune Response, Safety and the Occurrence of Respiratory Syncytial Virus (RSV)-Associated Respiratory Tract Illness After Administration of RSV OA Vaccine in Adults 60 Years and Older

The Effect of Cancer Treatments on Speech Perception in Noise, Cognition, and Hearing-Related Quality of Life

The study will assess the effects of four different types of cancer treatments on speech perception in noise, hearing thresholds, cognition, and hearing-related quality of life over a follow-up period of 3 years. The speech perception in noise will be assessed using the Finnish matrix sentence test. Other hearing measures include transient and distortion product otoacoustic emissions, impedance audiometry and pure-tone audiometry extending to high frequencies (0.125kHz - 16kHz). Hearing-related quality of life will be assessed using Speech, Spatial, and Qualities 12 -questionnaire, Vanderbilt Fatigue Scale 10 -questionnaire and Tinnitus Handicap Index. Cognitive functions will be assed using Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) questionnaire and neuropsychological tests. The neuropsychological tests included in the study are Continuous Performance Test, Continuous Auditory Test of Attention, Trail Making Test A & B, Stroop Test, Coding and Digit span tasks from the Wechsler Adult Intelligence Scale - Fourth Edition, Word List task from Wechsler Memory Scale III, and Controlled Oral Word Association Test. Neuropsychological assessments will be conducted at baseline and 1 year and 3 years after the end of the treatments. All other assessments will be conducted at baseline and at 3-4 months, 1 year, and 3 years after the end of the initial treatments.