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  • Maternal Iron Deficiency and Childhood Health

    This will be a prospective cohort study in Tampere University hospital and The Wellbeing Services County of Pirkanmaa(Pirha). All pregnant women are recruited to participate to the study once they come to Tampere University Hospital for prenatal visits, for labor and/or at newborn pediatric examination performed by pediatricians usually at 2 days of age. After giving their online consent the mothers fill up a questionnaire online about possible maternal anemia and its diagnosis in pregnancy, iron deficiency and its diagnosis in pregnancy, maternal use of iron supplement or folic acid and it´s timing, about possible other chronic disease and their medications during pregnancy, and whether the mother has got intravenous iron infusions in pregnancy. Mothers are also asked for permission to collect their patient and medication data during pregnancy to improve the reliability and coverage or the study. Prospective recruitment for the study will be continued for 3,5 years. We aim for approximately 6000 mother- newborn pairs, of which approximately one third (2000 mothers) have got iron supplementation in pregnancy. The health of the offspring will be followed from inpatient records at The Wellbeing Services County of Pirkanmaa from birth until 7 years of age as described at specific aims. Information about neonatal outcomes recorded as they are recorded to the Finnish Medical Birth Registry are collected from the first 7 days of life. Neonatal health is followed also until 1 month of age or until hospital discharge from in- and outpatient records. At the next follow-up time points: 1.5 years, 4 years and 7 years of age, the information (growth, possible diagnoses, possible medications, need of support at school at 7 years of age), will be collected from the outpatient records at Health and Wellbeing Services of Pirkanmaa. Nested cohort 1 Once the mothers have given their consent to participate this MATILDA study, we identify 100 mothers with ID/IDA, who have used iron supplement and/or given i.v. iron infusions. They are recruited in chronological order inside the cohort for this nested cohort study number 1. A 100 control mothers without IDA/ID or diabetes, will be recruited in chronological order as well. Mothers for this nested cohort will be recruited at prenatal visits at Tampere University Hospital obstetric policlinic. Nested cohort 2 Prospective recruitment for the study will be continued for 2 years, and during this period we recruit 100 mothers who have had diabetes and insulin therapy in pregnancy, to this nested cohort study 2 from Tampere University Hospital. For these mothers with diabetes and insulin therapy, a 100 control mothers without maternal diabetes and iron deficiency, will be recruited. The controls are the same patients in both nested cohorts. The study participants will be recruited in chronological order from prenatal hospital visits or once they come to the hospital for labor. Mother´s hemoglobin, iron status (including reticulocyte hemoglobin) and C-reactive protein (CRP), will be tested once setting an i.v. route once they come to the hospital for delivery. The iron status of the newborn (small blood count, ferritin, transferrin receptor, reticulocytes including reticulocyte hemoglobin) and CRP, will be tested from umbilical cord blood. At 2-5 days of age at the same time once they are tested for metabolic screening or taken other laboratory tests, a small blood count and reticulocytes are being controlled. The iron status of the offspring (small blood count, ferritin, transferrin receptor, reticulocytes including reticulocyte hemoglobin) and CRP will also be controlled at 8 months, 2 years and 5 years of age. At 8 months, 2 and 5 years, the family will be sent an electronical questionnaire with questions about the child´s diet, sleep patterns, cognitive development and behavior. The families will be reminded about the laboratory tests and questionnaires once via text message. All the data will be stored at Tampere University Hospital´s safe research environment (Lokero) and pseudonymized before analysis. The data will be statistically analyzed in the safe research environment. The results of this study will be published in peer-reviewed international science journals. The study registry data will be held for five years after the study has ended and then destroyed following the instructions by Pirha. Timetable Research permits and approval for this project have been received from Wellbeing Services County of Pirkanmaa and ethical committee in January 2024. The amendment for the extension of follow-up and follow-up questionnaires is brought to the ethical committee in October 2024. Valtion tutkimusrahasto (VTR) has funded MATILDA-study in 2024. Additional funding for the nested cohorts will be applied during years 2024 and 2025 at least from Päivikki ja Sakari Sohlbergin Säätiö, Juho Vainion Säätiö, Pirkanmaan kulttuurirahasto, Lastentautien Tutkimussäätiö, Lääketieteen säätiö and Tays Tutkimussäätiö. The data collection for this MATILDA- project has begun in April 2024. A systematic literature review for maternal iron deficiency and it´s effect in offspring health is prepared during data collection as a part of PhD project for medical student Inna Anttila. Data collection with questionnaires will last up to 3.5 years and it will be finished by the end of year 2027 the latest. The recruitment for the nested cohort studies will begin as soon as the funding has been secured, and end as soon ad 100 participants for each group 1 and 2 and 100 controls have been recruited, by the end of year 2027 the latest. Main researcher (PI) in this MATILDA- project will be pediatrician Laura Seppälä from Tampere University Hospital (MD, PhD, neonatology fellow) and the nested cohorts will be run together with Pauliina Rinta-Jaskari (MD, pediatrician, PhD student). Other researchers in this project will be gynecologist Elli Toivonen from Tampere University hospital (MD, PhD), associate professor of developmental psychology Kati Heinonen-Tuomaala(PhD, adjunct professor), PhD student Inna Anttila (medical student) and PhD student Pilvi Saltiola (MD, GP), and perinatologist Kati Tihtonen (MD, PhD, Adjunct professor) and pediatrician Sauli Palmu (MD, PhD, acting professor). Based on the previous studies, we assume that the incidence of iron deficiency anemia is 40% in our pregnant population, and that 38% of the mothers benefit from iron supplementation. Our assumption is that 67% of the children benefit from the maternal iron supplementation. Based on these assumptions, our power of 6000 mother-child-pairs will be suitable for several multivariable statistics and analyses (Fisher´s exact p<0.00001). In the two nested cohorts, we use the same assumptions as in this bigger cohort. Needed samples size to study maternal iron status, iron supplementation and their impact on the iron status on the offspring is 200 mother-child units (Fisher´s exact p<0.00001). With this power calculation we assume the sample size to be sufficient also for multivariable analyses. The results of this wide prospective study will be published in peer-reviewed international scientific journals. The results of this study can be widely used in pregnancy planning and follow up, and possibly bringnew knowledge for guidelines for iron deficiency therapy, or the diagnosis for iron deficiency in children, especially newborns.

    Phase

    N/A

    Span

    558 weeks

    Sponsor

    Tampere University Hospital

    Tampere, Pirkanmaa

    Recruiting

    Healthy Volunteers

  • Artificial Intelligence Models to Predict Clinically Relevant Cardiovascular Outcomes

    PerCard is a retrospective and prospective observational study. The study aims to develop and validate models for prediction of intrahospital AF and recurrence of coronary events in a long-term follow-up using Artificial Intelligence. The development and internal validation of predictive models of AF involve two retrospective cohorts: - Cohort A: 1258 patients underwent CABG at Centro Cardiologico Monzino (CCM) between 2002 and 2016 - Cohort B: 2445 patients admitted for AMI STEMI or NSTEMI to CCM between 2010 and 2018 The development and internal validation of predictive models of coronary event recurrence in long-term follow-up involve a third retrospective cohort: -Cohort C: 1248 patients underwent CABG at CCM between 2002 and 2014 . External validation of the predictive models of in-hospital AF involves a cohort of patients admitted with AMI STEMI or NSTEMI, who will be prospectively enrolled at Coronary Intensive Care Unit of Centro Cardiologico Monzino. In the different prediction models, clinical and instrumental variables specific to patients with AMI (e.g., infarcted area), variables that are common to patients with any form of coronary revascularization (e.g., how many and which coronary vessels have been revascularized), or variables that are common to patients and individuals without established coronary artery disease (e.g., age, sex, history of hypertension, particular gene polymorphisms related to AF, signals from the ECG, etc.) will be included, where available. In addition, the contribution of 16 gene polymorphisms associated with predisposition to intrahospital onset of AF has been previously evaluated in cohort A and will be evaluated and compared in the prospective cohort at the Immunology and Functional Genomics Research Unit of Centro Cardiologico Monzino.

    Phase

    N/A

    Span

    125 weeks

    Sponsor

    Centro Cardiologico Monzino

    Tampere

    Recruiting

  • 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

    Phase

    3

    Span

    58 weeks

    Sponsor

    GlaxoSmithKline

    Tampere

    Recruiting

    Healthy Volunteers

  • Accuracy of EEG Slow Wave Activity in Predicting Favourable Outcome in Patients With Hypoxic Brain Injury - A Substudy of STEPCARE Trial

    STEPCARE Trial (Clinical trials identifier:NCT05564754) includes adult out-of-hospital cardiac arrest (OHCA) patients, with sustained ROSC, who remain comatose after resuscitation. STEPCARE is a factorial Trial, where all participants are randomized regarding three different interventions (minimal or deep sedation, target mean arterial pressure 65mmHg or 85mmHg, temperature management with or without a device). Patients with suspected or confirmed intracerebral hemorrhage, trauma or hemorrhage as reasons of arrest, those previously randomized to STEPCARE and patients with allergy to adhesive material or skin injury in the frontal-temporal area will be excluded (the latter two specific to this substudy). The investigators aim to assess whether a new, algorithm-based index derived from continuous EEG (cEEG) recording is superior to retrospective visual analysis of cEEG in predicting functional outcome after OHCA, assessed restrospectively from early phase recordings, using the best hour within the 9-12-hour time interval after ROSC. The cEEG will be collected using a commercially available Brainstatus device in selected centers participating in the STEPCARE Trial. cEEG will be visible to clinical team in centers using cEEG in routine monitoring, but blinded for those who do not routinely monitor cEEG in OHCA patients. C-Trend Index is blinded to clinicians and researchers, and will be analyzed retrospectively, after the primary outcome has been collected of the last patient of this substudy. The primary outcome of this substudy is the functional outcome 6 months after OHCA, defined as modified Rankin Scale score (dichotomized as favourable mRS 0-3, and unfavourable mRS 4-6), assessed by blinded outcome assessors. The investigators will compare accuracy (with separate comparisons of sensitivity and specificity) of C-Trend Index 9-12 hours after ROSC with the visual assessment of cEEG. C-Trend Index above a predefined cut-off value 20 is defined as indicative of favorable outcome, while in the visual assessment continuous or nearly continuous normal-voltage background without abundant discharges is considered indicative of favorable outcome . To demonstrate a 10% difference in the accuracy, a sample size of 271 patients is needed. To account for loss of patients due to early wake-up, loss of follow-up, and technical issues in recordings the investigators aim at recruiting 300 patients. As secondary research questions the study will also assess: - The predictive accuracy off C-Trend Index in predicting unfavorable functional outcome, compared with visual analysis of cEEG - The predictive accuracy of C-Trend Index using cut-off values 50 and 80 at 9-12 hours from ROSC in predicting favorable and unfavorable functional outcome - Whether the predictive ability or the optimal cut-off value of C-Trend Index in predicting favorable and unfavorable functional outcome is affected by the three different interventions of the STEPCARE study

    Phase

    N/A

    Span

    188 weeks

    Sponsor

    University of Helsinki

    Tampere

    Recruiting

  • A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis

    Phase

    3

    Span

    148 weeks

    Sponsor

    Amgen

    Tampere

    Recruiting

  • Feasibility of Aspirate Tissue Monitoring in Neuro-oncological Surgery

    During glioma surgery, the diffuse boundary between healthy tissue and tumor is localized using 5-ALA drug-enhanced fluorescence of cancer cells. Visual fluorescence-based tissue recognition technique using 5-ALA has been shown to improve the rate of tumor removal and slow disease progression. To see the fluorescence typical of cancer, a special light source is needed in the operating microscope. In typical blue light, the fluorescence is visible, but it is more difficult detect anatomical landmarks, such as cerebral blood vessels and cranial nerves, which makes them vulnerable to injuries. Tumor cells can also be unnoticed because of visual obstacles or weak fluorescence, which may lead to local recurrence and reoperations. Unintended tumor remnants are frequent even though many other auxiliary techniques such as MRI guidance, neuronavigation, ultrasound and neurophysiological monitoring are used. This multicenter controlled clinical trial investigates the clinical performance and outcomes from using an aspirate tissue monitor (ATM, Marginum Ltd HIVEN™) that detects cancerous tissue from the suction waste during the surgical treatment of suspected high-grade gliomas. The ATM provides near real-time audible feedback to the surgeon when tumor-related fluorescence is detected in the aspirated tissues. The trial investigates if the use of ATM to detect 5-ALA induced fluorescence contributes to faster tumor removal, less blood loss, less unintended residual tumor, less morbidity, longer survival and the frequency of local reoperations. In total fifty (n=50) patients referred for resection surgery for suspected high-grade glioma or its recurrence at the Kuopio University Hospital, Tampere University Hospital and Oslo University Hospital, and potential other trial sites, will be recruited to the study. The patients are prescribed oral 5-ALA preoperatively according to the institution's practices. The cases are compared with controls (n=50) from applicable local clinical site registers (matched controls). The cases are operated with the help of aspirate tissue monitoring and the controls without. Other preferred adjunct techniques are used in both groups. Informed written consent will be obtained from patients to participate in the study on the new surgical device. The clinical trial is approved by the local research ethics committees and approved by the Finnish Medicines Agency (Fimea) and Norwegian Medicines Agency (NoMA). Patients are asked for permission to pool unidentified study data from surgical patients collected at different research institutions. The investigated device is a CE equivalent or CE marked.

    Phase

    N/A

    Span

    205 weeks

    Sponsor

    Kuopio University Hospital

    Tampere, Pirkanmaa

    Recruiting

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

    Phase

    N/A

    Span

    731 weeks

    Sponsor

    Nordic Lymphoma Group

    Tampere

    Recruiting

  • A Real-World Study to Gain Clinical Insights Into Faricimab (FaReal Study)

    Phase

    N/A

    Span

    176 weeks

    Sponsor

    Hoffmann-La Roche

    Tampere

    Recruiting

  • Tampere Coronary Artery Disease and Sudden Cardiac Arrest Study

    Source data verification is not planned for the baseline data acquisition. SCD data is collected from the national death certificate register, which is mandated by Finnish legislation. Death certificates must include information about all the significant prevalent diseases and the events and circumstances leading to death. Also, data regarding the cause of death (ICD-10 classification) and the place of death must be included. The certificate is written by the last physician treating the patient and is complemented with medical or medicolegal autopsy results if available. Research members will fully review all detected SCD case from medical records and death certificates. Patients treated for CAD in Tampere Heart Hospital are recruited by research staff according to up-to-date Standard Operating Procedures (SOP). Research staff will conduct surveys and physiological measurements and take a blood sample in as planned. The blood sample is processed and stored according to research plan. The collected data is entered and saved to the Tampere Heart Hospital RedCap database. All research staff is trained according to up-to-date SOP. The final analytics of the blood samples including genetic testing will be decided later. The study is designed to have 80% power (alpha 0.05) to demonstrate a small-medium effect (Cohen's D 0.2-0.5) for normally distributed variables. To this end, 150-200 SCD cases should be detected in the follow-up. Based on previous research, 4000 subjects with four years of follow-up need to be recruited to fulfil the target number of SCD cases. With this sample, a 2.5-3.5 times risk ratio for categorical variables could be detected (80% power). Missing data will be addressed as such. If significant number of study subjects with missing data will be detected data imputing can be considered during analysis. Prospective data regarding SCD will be analyzed in addition to conventional statistical methods, with Cox regression model. Also Fine Gray subdistribution models will be used. Machine learning model can used especially analyzing ECG and genetic data.

    Phase

    N/A

    Span

    938 weeks

    Sponsor

    Tampere Heart Hospital

    Tampere, Pirkanmaa

    Recruiting

  • Exercise-based Rehabilitation in Patients with Pulmonary Artery Disease

    Effects of group form exercise-based outpatient rehabilitation to Exercise Capacity, Quality of Life and Physical Activity in pulmonary artery hypertension (PAHexercise) Pulmonary arterial hypertension (PAH) is a rare, severe and life-threatening disease with a poor prognosis, even with current medical treatments. In addition to medication, exercise rehabilitation has been shown to positively impact patients' functional capacity and quality of life. Following the diagnosis, patients often reduce their physical activity, experiencing hesitancy and uncertainty regarding safe exercise practices. However, the 2022 ESC/ERS international treatment guidelines recommend exercise rehabilitation for PAH patients with evidence level 1A. The strongest evidence for the benefits of rehabilitation comes from international multicenter studies, where rehabilitation has primarily occurred in hospital settings. There is no suitable or feasible guideline for outpatient-based exercise rehabilitation. However, studies indicate that exercise rehabilitation is safe for medically stable patients. The aim of our research is to investigate and describe whether group-based outpatient exercise rehabilitation has an impact on the exercise capacity, quality of life, and physical activity of patients with pulmonary arterial hypertension. Additionally, we aim to develop an effective model for outpatient exercise rehabilitation for Finnish PAH patients. The rehabilitation will be supervised by experienced physiotherapists. Only patients in stable condition under effective medication will be included in the study, ensuring the safety of the rehabilitation. Furthermore, international safety standards, such as those related to oxygen saturation, heart rate, and hemoglobin levels, will be adhered to. Overexertion will be avoided. The rehabilitation sessions will take place in the facilities of the Tampere Heart Hospital, and a contingency plan has been developed to manage any adverse events. Objectives, Primary, and Secondary Outcomes The study aims to: - Demonstrate the efficacy of a group-based outpatient rehabilitation program in improving the physical performance, quality of life, and physical activity of PAH patients. - Assess long-term adherence to regular exercise training. - Compare results to international standards to establish the program's suitability within the Finnish healthcare system. Primary Outcome: Change in 6MWT results compared to baseline. Secondary Outcomes: - Change in Quality of life (SF-36). - Change in WHO functional classification. - Change in NT-proBNP biomarker levels. - Changes in echocardiographic parameters. - Change in the ESC risk classification score. - Changes in muscle strength, respiratory parameters, balance, daily step count, and insomnia severity. Research Methods The study is a prospective, observational, non-controlled, quantitative study. It is a non-randomized case study focusing on a small group in a specific context. Quantitative methods will be used to analyze data, using participants' baseline and historical follow-up results as comparators. Due to the small patient cohort, a formal power analysis is not feasible. However, the goal is to demonstrate that the chosen rehabilitation method achieves a median improvement in 6MWT results comparable to those observed in large, randomized multicenter trials. Schedule of the Research Participants (maximum 20, minimum 8) will be recruited between 2025 and 2030. PAH is a rare disease, with international studies including sample sizes ranging from 7 to 183 participants. The target group comprises PAH patients under follow-up at the cardiology outpatient clinic of Tays Heart Hospital. Implementation of the Research Inclusion and Exclusion Criteria Inclusion Criteria: - Adults over 18 years old residing in Tampere or nearby municipalities. - WHO functional classification II-III. - Commitment to the exercise program. - Stable disease condition with no PAH medication changes in the two months prior. - No recent syncope or arrhythmias causing symptoms within the past two months. Exclusion Criteria: - Severe pulmonary disease or left ventricular failure (HFrEF). - Pregnancy. - Severe congenital heart defect (Eisenmenger syndrome). - Severe liver disease. - Acute inflammatory condition. - Severe anemia (hemoglobin ≤ 75% of the lower reference limit). - Systolic blood pressure below 85 mmHg. - Recent syncope. - Other significant conditions affecting physical capacity, such as severe neurological diseases or musculoskeletal issues. - Untreated severe arrhythmias. - Changes in PAH medication during the rehabilitation program. Execution of Rehabilitation The program includes once a week total 15 group exercise sessions led by a physiotherapist, along with three individual sessions for baseline, post-program, and one-year follow-up assessments. Group sizes are limited to a maximum of four participants. Each session consists of: 1. Warm-up. 2. Circuit training focusing on muscle strength. 3. Cool-down. Participants will also follow a home-based exercise program, including endurance, strength, and respiratory exercises. Metrics Performance metrics include the 6MWT, grip strength, chair stand test (10 repetitions), single-leg standing, respiratory function tests, and inspiratory muscle strength measurements. Participants will complete the SF-36, ISI (Insomnia Severity Index), and IPAQ (International Physical Activity Questionnaire) surveys before, after, and one year after the program. Daily physical activity will be tracked using a step counter. Echocardiographic evaluations will be conducted before and after the program, with potential mid-program assessments. Blood tests will monitor NT-proBNP and hemoglobin levels.

    Phase

    N/A

    Span

    101 weeks

    Sponsor

    Tampere Heart Hospital

    Tampere, Pirkanmaa

    Recruiting

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