Clinical trials

Acute otitis media (AOM) is the most common bacterial infection in young children and a major contributor to healthcare utilization and costs. Diagnosis relies on otoscopy and identification of tympanic membrane (TM) bulging, yet physician-performed otoscopy has variable diagnostic accuracy and depends heavily on clinical expertise. Digital otoscopy combined with artificial intelligence (AI)-based image analysis has demonstrated high diagnostic accuracy in previous studies. In a recent study by our group, digital otoscopy with an automated neural network classifier reliably ruled out otitis media in children. The PARENT-EAR randomized controlled pilot trial aims to evaluate whether parent-performed digital otoscopy at home, combined with retrospective AI analysis of captured TM images, can reduce physician visits due to suspicion of AOM. The study also assesses feasibility, diagnostic accuracy of parents after training, and potential effects on antibiotic use and healthcare utilization. Methods and outcomes The PARENT-EAR trial is a randomized controlled pilot trial conducted at Vaasa Central Hospital and Turku University Hospital. Recruitment will occur between September and December 2026 (extended if necessary), with follow-up ending May 31, 2027 (5-9 months per participant). Children aged 12 to 47 months with at least one AOM episode in the past 12 months will be randomized 1:1 using permuted block randomization. Exclusion criteria include tympanostomy tubes, tympanic membrane perforation, middle ear effusion at recruitment, immunosuppression, previously diagnosed hearing loss or anatomical abnormalities predisposing to AOM, and otoscopy experience of the parent. Intervention group: Parents receive a digital otoscope (The Ear Penguin by Sibbo Medical Devices, MDR EU Class I device) and training on TM image interpretation. They complete a TM image classification quiz before and after the training. During follow-up, parents perform home otoscopy when suspecting AOM, capture TM images/videos, interpret findings, and record symptoms in a diary. If AOM is suspected or the child appears ill, medical evaluation is instructed. Control group: Standard care without home otoscopy. Parents complete the same symptom diary and seek care according to usual practice. Statistical analyses will compare outcomes between groups. AI-based TM classification will be compared against expert panel evaluation. This is a pilot study with a target sample size of 20 children per arm, limited by device availability. Ethical aspects, data collection and handling The study will be conducted in accordance with the Declaration of Helsinki. Written informed consent will be obtained from all parents after provision of oral and written information. Participation is voluntary, and families may withdraw at any time. Investigators may discontinue participation if deemed in the child's best interest. The digital otoscope is a CE-marked Class I medical device used solely for visual inspection of the tympanic membrane. Pneumatic pumps are not provided. Potential risks include minor ear canal abrasions or discomfort; serious adverse events are considered rare. Any adverse events will be managed according to standard clinical practice and reported to relevant authorities when required. The study is investigator-initiated. The device manufacturer provides the otoscopes but has no role in study design, data access, or analysis. Data will be collected via paper symptom diaries, monthly REDCap questionnaires (University of Turku), and national electronic health records (Kanta). TM images and videos will be securely stored and imported into a research database with relevant metadata. All data will be handled in accordance with the EU General Data Protection Regulation (GDPR 2016/679). Study data will be pseudonymized and identified only by study ID numbers. The key linking personal identifiers to study IDs will be stored separately and securely. Paper diaries will be destroyed after digitalization. Consent includes permission to access health records and to use collected images and data for scientific purposes. Results will be published in peer-reviewed journals and as part of a doctoral thesis.

The aim is to investigate whether the tissue-preserving tonsil surgery technique is as effective as complete tonsil removal in the treatment of obstructive sleep apnea. The primary outcome measure is the change in the apnea-hypopnea index (AHI) before surgery and at 4-6, 24, and 60 months after surgery.

The goal of this study is to optimize the duration of sick leave and the usage of opioids following partial tonsillar surgery in adults by comparing the recovery after extracapsular tonsillectomy (ECTE) with recovery after intracapsular tonsillectomy (ICTE). An additional objective is to confirm that ICTE is as effective as ECTE when comparing TOI-14 scores after 12 months post-operatively. The main questions the study aims to answer are: * Is 10 days sick leave enough after partial tonsillectomy (ICTE)? * Are opioids needed at all after partial tonsillectomy (ICTE)? * Is ICTE as effective as ECTE when comparing TOI-14 symptom scores after 12 months from the surgery? Adult patients who are scheduled to tonsil surgery are randomised into 2 groups: ICTE and ECTE. Patients are blinded. Postoperatively they will answer structured questions about the recovery and effectiveness of the surgery. The last follow up survey is 60 months after the surgery.

The study examines the association of digitally provided EMPOWER - exercise intervention on 3-6-year-old child's physical activity (PA), motor performance and quality of life (QoL) during and after cancer treatment. In addition, the factors that influence the feasibility of the intervention will be examined. The research is carried out in cooperation with Turku University of Applied Sciences, Turku and Tampere University Hospitals. Cancer treatments significantly reduce the amount of PA of the child impairing the normal motor development. Delay in normal motor development may cause childhood cancer survivors a higher risk of developing adverse health effects in adulthood. Data on children's PA and condition is collected using questionnaires and sensors. In addition, children's motor performance and QoL are examined through tests and questionnaires. The feasibility of the intervention will be examined from the parents and nursing staff through questionnaires and interviews.

This study explores whether recurrent breast cancer can be safely treated with breast-conserving surgery and repeated radiation therapy in cases where patients have previously undergone radiation. Traditionally, recurrent breast cancer has been treated by removing the entire breast. However, recent research has shown that in certain situations, it may be possible to preserve the breast. The study will collect data on the safety of this treatment approach and its effects on patients. The treatment follows standard breast cancer care practices, involving 30 patients from Helsinki and Turku University Hospitals. Patients are carefully selected based on specific criteria, such as tumor size, localization, and prior treatment history. Special attention is given to the planning of radiation therapy and surgical techniques. The goal is to develop new treatment strategies that allow breast preservation even in cases of recurrent breast cancer, providing patients with high-quality and individualized care.

The goal of this intervention study is to learn if giving children influenza vaccinations in early childhood education facilities (i.e., daycare) will increase vaccination coverage compared to giving vaccinations only at healthcare. The main question it aims to answer is: • Does offering children nasal influenza vaccine in daycare result in higher proportion of children getting influenza vaccine. Researchers will compare daycare setting and healthcare setting as the location of giving influenza vaccines to children to see if more children will get vaccinated if they have an opportunity to receive nasal influenza vaccine at daycare. Participants in the intervention group will: • Have the opportunity to receive influenza vaccine in the daycare or in the healthcare Participants in the comparison group will: • Have the opportunity to receive influenza vaccine in the healthcare only

The aim of our study is to investigate changes of brain perfusion and elasticity in neonates during the time that a neonate is adapting to live outside the womb and during diseases that are suspected to affect neonatal brain perfusion. We use contrast enhanced ultrasound (sulphur hexafluoride) and ultrasound-assisted elastography to evaluate the state of brain perfusion. We will study neonates recruited from the Neonatal Units of Turku University Hospital.

Close Collaboration with Parents intervention is an evidence-based educational intervention for the entire multi-professional staff of neonatal intensive care units (NICUs). The goal of the intervention is to strengthen partnership between staff and parents, enhance parental participation in infant care. There are no studies yet about the effects of the Close Collaboration with Parents intervention on the long-term neurodevelopment and socio-emotional development of very preterm infants and their interaction with their parents. Accordingly, a multicenter cluster randomized controlled trial is planned. Prior to initiating this large-scale study, it is essential to validate the measurement instruments. Therefore, a pilot study will be conducted to assess their feasibility and to determine the appropriate sample size.

In high-income countries, coronary artery bypass grafting (CABG) remains a common procedure, with approximately 36.7 operations per 100,000 inhabitants annually, corresponding to about 136,000 procedures in the European Union. This highlights the substantial healthcare burden and the need to optimize surgical outcomes. Cardiopulmonary bypass (CPB) is a fundamental component of cardiac surgery, ensuring extracorporeal perfusion of vital organs. Hypothermic CPB has historically been widely used for organ protection due to its presumed neuroprotective mechanisms. However, evidence demonstrating its superiority over normothermic CPB remains inconclusive. In its 2024 guidelines, the European Association for Cardio-Thoracic Surgery recommends considering normothermia (≥35 °C) to reduce postoperative neurocognitive dysfunction (Class II, Level A). This recommendation is primarily based on two meta-analyses, but the underlying studies show methodological heterogeneity, outdated practices, and limited applicability to contemporary cardiac surgery. Importantly, the guidelines acknowledge the need for large randomized controlled trials to define optimal target temperature management (TTM) during CPB. Previous diffusion-weighted MRI studies have demonstrated silent ischemic brain lesions in approximately 30% of CABG patients, with postoperative neurocognitive decline occurring in a similar proportion. However, no significant differences have been shown between normothermic and hypothermic CPB. Diffusion tensor imaging (DTI) extends conventional diffusion imaging by enabling detailed assessment of white matter microstructure and tractography. Fractional anisotropy (FA), a key DTI metric, has demonstrated prognostic value in various neurological conditions but has not yet been applied in CABG patients. Blood-based biomarkers, including glial fibrillary acidic protein, neurofilament light chain, neuron-specific enolase, and total tau, offer complementary insights into brain injury but have not been studied in combination with DTI in this population. This study will compare mild hypothermic (33-34 °C) and normothermic (36.5 °C) CPB to evaluate their neuroprotective effects using advanced MRI techniques and blood-based biomarkers. The primary aim is to determine whether mild hypothermia provides superior neuroprotection following CABG. Secondary objectives include assessing white matter injury evolution, global ischemic burden, associations with biomarkers and neurocognitive decline, and developing integrated prognostic models to improve outcomes in CABG patients.

The principal aim of this study is to evaluate the usability of the Hope-D gestational and 6 months postpartum weight management program. We will evaluate the usability, functionality, and acceptability of the developed Hope-D weight management program that includes digital pathway for weight management, general or individual weight management plan and individual or group coaching for weight management from pregnancy to 6 months postpartum.

The aim of this study is to explore the information provided to mothers about labor induction and its connection to their childbirth experience. In addition, the study examines how the use of social media may influence the birth experience among patients undergoing labor induction.

Whole body CT is the primary imaging method in staging and follow-up of colon cancer. Conventional PET-CT with 18F-labeled fluorodeoxyglucose (18F-FDG) has its limitations and has a secondary role in colon cancer protocols. A new PET tracer, fibroblast activation protein inhibitor (FAPI), targeting a protein that is overexpressed by cancer-associated fibroblasts presents a potential new PET imaging tool. The objective of this prospective study is to evaluate diagnostic efficacy of 18F-FAPI-74 PET/CT in patients with colon cancer. The aim is to evaluate the sensitivity and specificity of 18F-FAPI-74 in detection of local lymph node metastasis and distant metastasis in patient level in patients with colon cancer in primary staging and when suspected recurrence. 100 patients with colon cancer are enrolled and PET/CT studies are performed with the novel 18F-FAPI-74 tracer. The data will be collected between 2024-2026.

The goal of this observational study is to compare fetal liver ultrasound radiomics between pregnancies complicated by type 1 diabetes and healthy controls. The main questions it aims to answer are: * Are fetal liver ultrasound radiomic features reproducible? * Does fetal liver ultrasound radiomics differ between pregnancies complicated by type 1 diabetes and healthy controls? Participants will undergo ultrasound examination to collect ultrasound data for the analyses.

The participants receive instructions on two tonsil size classification scales and then, using a tongue depressor as well as their mobile phone camera and/or a flashlight and a mirror, the participants assess the size of their own tonsils on two scales. After the self-assessment, a medical student and two ear, nose, and throat (ENT) specialists evaluate the participants' tonsil size using a tongue depressor and a headlamp, applying the same scales. The objective of this study is to demonstrate that patient self-assessment constitutes a sufficiently accurate method for evaluating tonsil size. Furthermore, it aims to show that patients experiencing conditions such as sleep apnea or swallowing difficulties can, on the basis of their own assessment, be appropriately referred to an otolaryngologist for surgical evaluation, thereby conserving healthcare resources and reducing the time burden for patients.

To study the vaginal and oral microbiome by swab samples. On selected cases, also papa smear will be studied.

The goal of this randomized and controlled trial is to assess the effectiveness of group schema therapy in the treatment of adolescents with borderline symptoms. The intervention utilizes self-recorded video material as an experiential method. The intervention comprises 30 group sessions and 8 individual sessions. Additionally, there are group sessions for the participants' parents. Participants in the control group receive treatment as usual.

Staging pancreatic cancer (PC) presents a clinical challenge. Triphasic whole body CT is the primary imaging method in diagnosing, staging and during follow up. Conventional PET/CT with 18F-labelled fluorodeoxyglucose (18F-FDG) has its limitations and therefore has a secondary role in imaging pancreatic cancer patients. These conventional imaging methods are good in detecting primary tumors and distant metastasis but poor in detecting local lymph node metastasis. A new PET tracer, fibroblast activation protein inhibitor (FAPI), targets FAP, a protein overexpressed in cancer-associated fibroblasts. It presents a potential new PET imagining tool. The objective of this prospective diagnostic study is to evaluate the diagnostic efficacy of 18F-FAPI-74 PET/CT in patients with PC. The aim is to evaluate the sensitivity and specificity of 18F-FAPI-74 in detection of local lymph node metastasis and distant metastasis in patient level in patients with PC in primary staging and when suspected recurrence. 100 patients with PC are enrolled on whom PET/CT studies are performed with the novel 18F-FAPI-74 tracer. The data will be collected between 2024-2026.

The study aims to clarify the usefulness of 3D-printed replicas in association with autotransplantation of teeth in children and young adults.

The aim is to study whether the microbiota of children who are exposed to antibiotics at birth could be modified by synbiotic supplement and thereby reduce the risk of obesity, chronic diseases and respiratory tract infections. A total of 125 mother-child pairs will be recruited in this randomized, double-blind, placebo-controlled study. Infants are randomized to receive either a synbiotic supplement or a placebo for 2 months, after which their growth and morbidity will be monitored at the research clinic for 2 years.

OCTAGON trial is a randomized, double-blinded, parallel-group non-inferiority multicenter (Helsinki and Turku University Hospitals, Finland) clinical trial according to CONSORT criteria. 194 adolescents with idiopathic (major curve \> 45 degrees) or neuromuscular scoliosis (major curve \> 50 degrees) are enrolled for the OCTAGON trial comparing pooled human plasma (Octaplas, 10mL/kg, active management) vs. Plasmalyte (10 mL/kg, placebo) before incision as part of the normal intraoperative fluid therapy. Data is collected at baseline and at each follow-up until a minimum of 2-year follow-up. Outcomes Outcomes for the OCTAGON trial include 1) intraoperative blood loss (in mL, primary outcome) and the need for allogenic red blood cell infusion (percentage of patients). Secondary outcomes include health-related quality of life (Scoliosis Research Society 24 outcome questionnaire), postoperative pain (48-hour opioid consumption), operative time (hours), drain output (mL), hidden blood loss (mL), hospital stay, and complications (skin reactions, TRALI, deep surgical site infection, neurologic deficit). Research questions and hypothesis Does prophylactic use of pooled human plasma decrease intraoperative blood loss in adolescents undergoing instrumented spinal fusion for scoliosis? We hypothesize that pooled human plasma will reduce intraoperative and total blood loss by 25% resulting in lower need for blood transfusion and fewer surgical site infections. Objectives To compare the effect of pooled human plasma vs. crystalloid fluids on intraoperative bleeding and total blood loss (drain output and hidden blood loss) in children undergoing posterior spinal fusion for AIS and NMS. Adverse events will be recorded and reported as minor (skin reaction) or major (severe allergic reaction, transfusion related acute lung injury, TRALI, deep surgical site infection, neurologic injury). Ethical aspects The PHP trial has been evaluated via European regulatory authority (EU CT: 2024-514857-31-00) and by Fimea (FIMEA/2024/006588). Informed consent is obtained from the parent(s). Results will be disseminated in high-quality peer-reviewed publications. The individual patient safety and high-quality management of fractures and scoliosis is a priority in this trial. The randomization can be opened at any stage of the treatment process. Based on the clinical decision the randomized treatment can be terminated and treatment provided accord-ing to clinical decision making even if results will be evaluated using the intention to treat princi-ple. Pain management will be prioritized in every clinical scenario and parental presence is always possible.

An investigator-initiated clinical drug study Main Objective: To explore neuroprotective properties of xenon in patients after aneurysmal subarachnoid hemorrhage (SAH). Primary endpoint: Global fractional anisotropy of white matter of diffusion tensor imaging (DTI). Hypothesis: White matter damage is less severe in xenon treated patients, i.e. global fractional anisotropy is significantly higher in the xenon group than in the control group as assessed with the 1st magnetic resonance imaging (MRI). After confirmation of aSAH and obtaining a signed assent subjects will be randomized to the following groups: Control group: Standard of Care (SOC) group: Air/oxygen and Normothermia 36.5-37.5°C; Xenon group: Normothermia 36.5-37.5°C +Xenon inhalation in air/oxygen for 24 hours. Brain magnetic resonance imaging techniques will be undertaken to evaluate the effects of the intervention on white and grey matter damage and neuronal loss. Neurological outcome will be evaluated at 3, 12 and 24 months after onset of aSAH symptoms Investigational drug/treatment, dose and mode of administration: 50±2 % end tidal concentration of inhaled xenon in oxygen/air. Comparative drug(s)/placebo/treatment, dose and mode of administration: Standard of care treatment according to local and international consensus reports. Duration of treatment: 24 hours Assessments: Baseline data Information that characterizes the participant's condition prior to initiation of experimental treatment is obtained as soon as is clinically reasonable. These include participant demographics, medical history, vital signs, oxygen saturation, and concentration of oxygen administered. Acute data The collected information will contain quantitative and qualitative data of aSAH patients, as recommended by recent recommendations of the working group on subject characteristics, and including all relevant Common Data Elements (CDE) can be applied. Specific definitions, measurements tools, and references regarding each SAH CDE can be found on the weblink here: https://www.commondataelements.ninds.nih.gov/SAH.aspx#tab=Data\_Standards.

The study will assess the effect of cancer treatments on speech perception in noise, cognition, and hearing-related quality of life by monitoring 200 cancer patients receiving standard care for their underlying malignancy.

The OVERCOME-TBI project aims to collect multimodal data approximately 1-4 and 11-14 years after an earlier well-documented traumatic brain injury (TBI) and examine factors that influence disease progression in order to gain new scientific insights into the long-term pathophysiology of TBI and identify new therapeutic targets. TBIs are among the most serious health problems worldwide and represents a significant burden for the injured, their families and society. It is estimated that more than 50 million people in the world suffer a TBI every year and half of all people will suffer a TBI in their lifetime. TBI diagnostics has lagged significantly behind that of many other diseases. The current methods for assessing severity and predicting outcomes are based only on initial stage variables, and there are no objective tools for monitoring disease progression. The current acute severity indices have shown only a modest association with outcome, particularly in patients with mTBI. However, even in patients with moderate-severe TBI, clinical predictors and imaging together explain only 35% of the variance in outcomes. In the OVERCOME-TBI project, patients with a history of TBI sustained 1-4 and 11-14 years earlier will undergo extensive neurological, biochemical, microbiological, gastroenterological and imaging examinations. The patients have previously participated in the prospective studies of our research group, so that data on acute injuries, blood-based biomarkers and advanced imaging results are already available. The results are expected to yield objective diagnostic and treatment methods for the diagnosis of progressive brain disease after brain injury and for the identification of microbiome-gut-brain axis dysfunction associated with disease progression.

The goal of this study is to learn if a simple home exercise program can benefit patients with advanced chronic kidney disease. There is also an observational part of the study without an exercise program. The study will record patients' mortality, cardiovascular events, emergency department visits, hospital stays, need for dialysis and 6 minutes walking distance. Also maximal oxygen uptake, quality of life and bone fractures are recorded and blood tests and X-rays analyzed. The prospective observational part of the study will investigate the link between cardiovascular and kidney health as well as exercise capacity and adverse outcomes.

The study explores fecal microbiota transfer via retention enema after the first clostridioides difficile episode.