Turku

Researchers are evaluating the usefulness of 3D-printed tooth replicas in combination with autotransplantation of teeth for children and young adults who have lost teeth. This study focuses on comparing the use of these 3D generated tooth replicas with the conventional tooth transplantation procedure to see how well they work in tooth replacement. Participants will receive tooth transplants either using the 3D printed replicas or the traditional method. The 3D generated replicas serve as a device to assist in the transplantation process. The study aims to determine whether the 3D replicas improve the transplantation outcome compared to the conventional approach. During the study, researchers will monitor and assess the health of the transplanted teeth through clinical and radiological examinations one year after the procedure. They will track the number of patients with healthy transplanted teeth at this one-year mark to evaluate the success of the interventions. Participants in the study are children and young adults between 9 and 23 years old who need tooth transplantation and have an open apex tooth available for transplant.

Prostate cancer is the most common cancer among men in Finland, with up to 20% of cases being metastatic at diagnosis and around 900 men dying from it each year. Accurate primary staging is critical for prognosis and treatment decisions. Current guidelines recommend bone scintigraphy and contrast-enhanced whole-body CT despite their low sensitivity for detecting metastases. This research evaluates a new imaging method, 99mTc-MIP-1404 SPECT/CT, which uses a small molecule that binds to PSMA, a molecule found on prostate cancer cells, aiming to improve detection of cancer spread compared to traditional scans. In this randomized prospective study, men with confirmed high-risk prostate cancer will undergo imaging with 99mTc-MIP-1404 SPECT/CT, which involves a single intravenous dose of the tracer. This will be compared to standard imaging methods, including bone scintigraphy and contrast-enhanced CT. Participants will also receive additional imaging tests such as PSMA/SPECT/CT and PSMA/PET/CT. The study aims to show if 99mTc-MIP-1404 SPECT/CT is better at detecting local lymph node metastases. During the study, men will be monitored for presence of lymph node metastases using these imaging tests. Researchers will collect data on the accuracy of the new imaging compared to standard methods. The study focuses on men aged 18 and older with specific high-risk prostate cancer confirmed by biopsy. Participants will provide informed consent and be followed to assess how well the new imaging detects cancer spread, supporting improved staging and treatment planning.

Researchers are investigating new treatments for advanced ovarian cancer, specifically in patients who do not have homologous recombination deficiency (non-HRD positive). This Phase 3 study aims to assess whether maintenance treatment with sacituzumab tirumotecan (sac-TMT), alone or combined with bevacizumab, can improve progression-free survival compared to the current standard care after initial platinum-based chemotherapy and surgery. Participants receive sacituzumab tirumotecan through intravenous infusion at a dose of 4 mg/kg. Some also receive bevacizumab intravenously at 15 mg/kg as part of their maintenance treatment. Before sac-TMT infusion, participants are given prophylactic steroid mouthwash and recommended rescue medications including histamine-1 and histamine-2 receptor antagonists, acetaminophen or equivalent, and dexamethasone or equivalent. The study compares these treatments to standard care or observation following first-line chemotherapy. During the study, participants are monitored for progression-free survival for up to approximately 49 months. Researchers will assess how long participants live without their cancer getting worse. Throughout the trial, safety and response to treatment are evaluated. The study includes women aged 18 years and older who have completed surgery and first-line chemotherapy with specific responses and meet certain health criteria.

In Finland, around 12% of children live in poverty, and many families face financial stress, low confidence in managing money, and limited access to financial support. This research evaluates a program designed to help families with complex financial difficulties by improving their financial skills and overall well-being. The study uses a randomized controlled trial to compare the effects of the FinSoc program against usual social work services, aiming to reduce financial anxiety and enhance economic self-efficacy. The FinSoc intervention includes five individual sessions with a trained social worker, covering budgeting, financial decision-making, emotions related to money, and how money affects relationships. These sessions use motivational interviewing and client-centered approaches to encourage participation and goal-setting. Families assigned to the intervention receive this structured program, while the control group continues with standard social work services and receives a material package promoting financial skills after final assessments. Participants will be involved in assessments at three points: before the intervention, shortly after it ends, and three months later. Researchers will collect data through questionnaires measuring financial literacy, anxiety, self-efficacy, and quality of life. Additionally, interviews with families and social workers will explore their experiences with the program, and feedback will be gathered after each session to improve the intervention. Social workers will also report on how well the program is followed, supporting the study's goal to improve family well-being and guide social work practices.

Researchers are evaluating the safety and effectiveness of a new drug called BAY 3547926 in people with advanced liver cancer known as hepatocellular carcinoma (HCC) that expresses a protein called Glypican 3 (GPC3). This first-in-human study aims to find the best dose of BAY 3547926 and to understand how the body absorbs and processes the drug. The drug carries a radioactive agent that targets cancer cells, causing damage to them while limiting harm to nearby healthy tissues. The study includes four parts. In Part 1, participants receive increasing doses of BAY 3547926 alone to identify the safest and most effective dose. In Part 2, a larger group receives BAY 3547926 alone at the chosen dose. In Parts 3 and 4, BAY 3547926 is given in combination with other treatments. Another drug, BAY 3547922, which is an antibody conjugate without the radioactive label, is used as a preinjection in the study. During the study, participants undergo health check-ups, body scans, and provide blood and urine samples. Researchers also ask about symptoms and general well-being. They will monitor side effects, tumor response using standard criteria, and progression of cancer for up to 60 months after the first dose. The study assesses safety, tolerability, drug levels in the body, and anti-tumor activity over this period.

Researchers are evaluating the long-term safety and effects of nerandomilast in people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) who have previously completed treatment with nerandomilast in earlier studies. The study aims to understand how well participants tolerate nerandomilast over time, and whether it helps improve lung function, delays symptom worsening, reduces hospital visits, or impacts survival. This is a Phase 3 open-label extension trial. Participants take nerandomilast tablets daily for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study follows an open-label design where all participants receive nerandomilast. There are no placebo or comparator groups in this extension phase. Throughout the study, participants regularly visit their doctors for health assessments and lung function tests. Doctors monitor any health problems or side effects experienced during treatment. The main outcome measured is whether participants experience any adverse events up to the final follow-up visit, which occurs at week 99. This close monitoring helps evaluate the long-term safety and potential benefits of nerandomilast in this patient group.

Researchers are evaluating ODM-212 in a phase 1/2, first-in-human study involving patients with selected advanced solid tumors that cannot be treated with curative intent. This study includes two parts: dose escalation and dose expansion, aiming to assess the safety and effects of ODM-212 on cancers such as mesothelioma, cholangiocarcinoma, non-small cell lung carcinoma, colorectal cancer, and other tumors with specific genetic alterations or based on emerging scientific data. Participants must have advanced or metastatic solid tumors and be in need of systemic treatment, having exhausted or being unsuitable for standard therapies. Participants receive ODM-212 tablets at doses of 5 mg and/or 40 mg during the study. The study is conducted in two parts, where the first part focuses on initial dosing and the second part expands to include a wider range of solid tumors harboring specific genetic pathway changes that may respond to the treatment. Throughout the study, participants are monitored closely for treatment effects and adverse events, with detailed evaluations guiding dosing and continuation. During the trial, participants undergo regular assessments including physical exams, laboratory tests, and performance evaluations. Researchers monitor the incidence and severity of treatment-emergent adverse events from the first dose up to one year after the last dose. Participants must comply with study protocols and provide informed consent. The study duration and follow-up allow comprehensive safety and efficacy evaluations of ODM-212 in this patient population.

Researchers are evaluating a digitalized cognitive behavioral therapy (CBT) program combined with telephone coaching for pregnant women experiencing depressive symptoms. The study focuses on mothers during pregnancy who have been identified with antenatal depression through routine maternity health check-ups. Participants are randomly assigned either to receive the guided digital CBT treatment or to a control group that receives educational material about depression in digital form. The intervention group receives weekly phone coaching alongside the digital CBT program, while the control group accesses psychoeducational material about depression digitally. The study targets pregnant women between 12 and 22 weeks gestation with depressive symptoms. The study does not specify phases but involves active treatment and control arms. Participants will be assessed using the Edinburgh Postnatal Depression Scale (EPDS) at the start and 11 weeks after randomization to measure changes in depressive symptoms. Eligibility involves language fluency, internet access, and specific pregnancy timing. Safety and monitoring include exclusion of those with severe psychiatric conditions or ongoing psychotherapy. The total participation includes baseline screening and follow-up after 11 weeks.

Researchers are conducting a phase III randomized, open-label, multicenter trial across several countries including Sweden, Norway, Finland, Denmark, Italy, Australia, and New Zealand. The study focuses on elderly patients with untreated diffuse large B-cell lymphoma (DLBCL), defined as patients aged 80 years or older, or those aged 75 years or older who are considered frail based on a simplified Comprehensive Geriatric Assessment. The trial aims to compare the effectiveness of two treatment regimens in this population. Participants are randomly assigned to receive either the standard R-miniCHOP treatment or an experimental R-pola-miniCHP regimen where vincristine is replaced with an immunoconjugate, polatuzumab vedotin. Both treatments involve cycles of drugs including rituximab, cyclophosphamide, doxorubicin, and prednisone, administered over 18 weeks. The trial includes a screening period lasting up to 4 weeks, followed by the active treatment phase, and then a follow-up period lasting up to 36 months after treatment completion. Throughout the study, participants will be monitored to measure progression-free survival over 2 years as the primary outcome. The study involves regular assessments including clinical evaluations and safety monitoring. Enrollment began in the first quarter of 2020, with the last patient visit expected by the first quarter of 2027, allowing for long-term observation of treatment effects and patient outcomes.

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.