There are about 3961 clinical studies being (or have been) conducted in Finland. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The main purpose of this study is to understand the impact of lifestyle coaching on the risk of future cardiometabolic disease, workability and self-assessed wellbeing. The data gathered during the study helps in the future to better identify different focus groups for more tailored interventions. The study consists of two main stages: screening and coaching phase. Screening Aava and the pension will recruit 2000 participants for screening from the employer companies. Screening participants are invited to answer a wellbeing questionnaire (Aava Virta questionnaire, Work Ability Index questionnaire) and give blood samples and physiological measurements, including weight, height, waist circumference, neck circumference and blood pressure. All subjects participating in screening will receive the results from wellbeing questionnaire immediately and they receive the results from blood test within few weeks. Of these 2000 screened persons, a total of 300 high-risk (according to ApoB/ApoA1) individuals and 600 medium-risk individuals will be selected to participate in the coaching phase. These participants are randomly split into treatment and control groups, so that eventually 150 high-risk and 300 medium-risk individuals are placed in both groups. Therefore, a total of 900 subjects carry forward to the coaching phase and in 1100 subjects the study ends. All 900 subjects entering coaching phase receive home a Firstbeat Bodyguard 2 device with instructions for performing Firstbeat wellbeing analysis. After the measurement the device is posted back for analysis according to instructions. The results and feedback from this test is received in the end of the study after the coaching phase. Stage 2: Coaching phase Within the coaching groups, participants in the high-risk category and treatment group undergo an individual coaching program. Participants in the medium-risk category undergo a group coaching program with similar aims. Both coaching programs last 10 weeks during which there are 8 almost weekly coaching sessions at the subjects worksite or near vicinity. Both coaching programs aim in reducing cardiometabolic risk factors and improving subjective well-being. The topics of the lifestyle coaching are 1) nutrition, 2) physical activity, 3) sleep and stress and 4) the long-term maintenance of lifestyle changes. The aims and methods in each coaching topic is based on Finnish recommendations on the topic. The coaching sessions include mostly discussions but in the sessions focusing more on physical activity there are also sessions including activity. In the halfway (5 weeks) of coaching phase, a second blood sampling and Aava wellbeing questionnaire are taken from all subjects (both coaching and control groups). In the end of the coaching phase (10 weeks) blood samples, Aava wellbeing questionnaire, Work Ability Index -questionnaire and physiological measurements are taken the last time. At this stage a second Firstbeat analysis is also performed. BBI-15 questionnaire is administered before and after the coaching phase. An open ended questionnaire regarding lifestyle change motivators and experiences before, during and after the coaching phase is administered to all participants. Also, a small subset (20 persons) of subjects takes in interviews to delve more detailed to the experiences during the study. End of coaching phase and study - start of feedback and analysis After the coaching phase has ended and the subjects (coaching and their control groups) have received all the results (wellbeing questionnaire, blood tests and Firstbeat results) for the study and feedback sessions will be held for all. Willing subjects also receive the results from the gene test in form of PRS scores ie. total genetic risk for three areas of health: heart disease, type 2 diabetes and obesity. THL gene results do not identify single gene variants. After this feedback session the study has ended for the subject. After all data in the study has been gathered starts the analysing and reporting phase for the researchers. At this stage the researchers can retrieve data from Aava patient records to analyse the effect of earlier diagnoses and findings. The information retrieved relate to ICD-10 diagnosis codes C00-C97 (malignant neoplasms), E00-E89 (endocrine, nutritional and metabolic diseases), F00-F99 (mental, behavioral and neurodevelopmental disorders), I00-I99 (diseases of the circulatory system) and M00-M99 (diseases of the musculoskeletal system and connective tissue) as these diagnostic codes can be important background factors for biomarkers of CVD and Type 2 diabetes risk and to some of the secondary endpoints like workability.
At least 12% of children have a chronic disease that requires regular medical follow-up after patients reach legal maturity. This international study aims to provide prospective evidence for improving health and wellbeing outcomes in this population. The primary hypothesis is that transition readiness will be more strongly associated with adherence to follow-up, fewer emergency visits and continued education than disease severity or chronological age. The secondary hypothesis is that positive experiences of care will be associated with lower levels of anxiety. Positive care experiences and low anxiety will predict better health-related quality of life during the transition period. A cohort of 504 young patients will be followed for three years. Patients have been recruited from pediatric hospitals 0-12 months prior to the transfer of care and follow-up will be completed after the patients have been followed for two years in adult healthcare.
The aim of the present study is to compare the success of dental fillings prepared using 3D printing technique to those manufactured with the direct composite technique. A total of 100 adult patients will be selected from dental patients attending Kaarina Municipal Health Care Centre from October 2020. The inclusion criteria are as follows: presence of multiple cavities, fractures or cosmetic demands on bilateral permanent teeth. The restorative demand should be a class II, III or IV on first or second molars, or premolars. At least two fillings should be from the same tooth group (premolar/molar) in each patient. This will be a split-mouth study, whereby one tooth on one side will be restored using direct technique, and the contra lateral tooth restored using the indirect technique through random allocation. For both direct and indirect restorations, commercially available short-fibre reinforced composite material (Ever X Flow, GC) is used for core material (replacing dentin) and flowable composite material (Gaenial Universal Injectable, GC) for surface (replacing enamel, appr. 2mm thickness from the surface), according the manufacturer´s instructions. Clinical evaluations will be conducted immediately after the final finishing, and after 1 year, 3 years and 5 years. The evaluation will be based on the United States Public Health Service (USPHS) criteria. Descriptive statistics will be used to describe the frequency distributions of the evaluated criteria. To analyse the failure rate for direct vs. indirect restorations, 2x2 tables will be created. Non-parametric statistical procedures will be used due to ordinally structured data for the assessment of the restorations. Mann-Whitney U-test will be used to explore significant differences at different time points between direct and indirect restorations.
The purpose of this trial is to find out if epcoritamab, also known as EPKINLY™ and GEN3013, is safe and works well as treatment for patients with diffuse large B-cell lymphoma (DLBCL) that are not responding to treatment, have grown in size, or have come back following treatment with at least 1 prior systemic cancer therapy. All participants in this trial will be randomly assigned to receive either epcoritamab or a pre-specified investigator's choice (standard of care) chemotherapy (either rituximab + gemcitabine + oxaliplatin [R-GemOx], or bendamustine + rituximab [BR]). Participants must have failed or be ineligible to receive an autologous stem cell transplant (ASCT). Epcoritamab will be injected under the skin. Investigator's choice chemotherapy will be given intravenously. Trial details include: - The trial duration will be up to 5 years. - All trial participants have a 21-day screening period, a treatment period, and a follow-up period that continues until death. - The estimated trial duration for an individual subject depends upon the treatment arm assigned: - Participants who receive epcoritamab will have 28-day treatment cycles. Epcoritamab will be given once weekly for the first 3 months, then every other week for 6 months, then every 28 days until lymphoma progression or unacceptable adverse events. - Participants who receive investigator's choice (standard of care) chemotherapy will receive treatments either: - R-GemOx: On Day 1 (or Day 1 & Day 2), and Day 15 (or Day 15 & Day 16) every 28 days, for up to 4 months; or - BR: On Day 1 and Day 2 every 3 weeks for up to 4.5 months.
The purpose of this study is to assess whether increased microglial activation (measured using TSPO-PET) at lesion rim is associated with more rapid lesion growth during 10 year follow up.
This study, A3921210 is designed to evaluate the efficacy, safety and pharmacokinetics (PK) of tofacitinib in pediatric participants with moderately to severely active UC. In the US and EU, patients with prior TNFi failure or intolerance will be enrolled. Outside of the US or EU, patients having had inadequate response or intolerance to oral or IV corticosteroids or azathioprine or 6-mercaptopurine or TNFi will be enrolled. All eligible participants will initially receive open label tofacitinib at a dose expected to produce equivalent systemic exposure to that observed in adults receiving 5 mg BID with the option for individual dose increase to 10 mg BID adult dose equivalent if dose escalation criteria are met. The primary objective of this study is to evaluate the efficacy of tofacitinib based on remission in pediatric participants with moderately to severely active UC. The primary endpoint is remission by central read Mayo score following 44 weeks in the maintenance phase. Remission is defined by a Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. The study Design is an open-label Phase 3 study that includes a screening period of up to 4-weeks duration, an 8-week or 16-week induction phase, a 44-week maintenance phase, and a 24-month extension phase for pediatric participants with moderately to severely active UC. Participants will have a follow-up visit 4 weeks after the last dose of study intervention and a telephone contact 8 weeks later to assess for any adverse events (AEs)/serious adverse events (SAEs). The total maximum duration of this study will be up to 180 weeks.
In this study we research patient segmentation made by Suuntima-service and it´s impacts to Quality of care, Service use and Costs of care among Type 2 Diabetes patients and Substance Abuse patients. With this Suuntima-servise based segmentation we assume to find appropriate services and Self-Management to allocate Type 2 Diabetes and Substance Abuse patients. We plan their care pathways by Suuntiman-service customership strategies (Self-acting, community, co-operation, network).
The purpose of this study is to assess safety and efficacy of BAY 1817080 compared to elagolix and placebo in women with symptomatic endometriosis. Study details include: - Study duration: 155 up to 285 days - Treatment duration: 84 days - Visit frequency: 3 laboratory every 2 weeks for participants on BAY 1817080 or placebo
Urinary tract infections (UTIs) account for 5-14% of pediatric emergency department visits annually. At the moment, up to one third of children suffering of acute (UTI) will have a new infection and there is a lack of effective methods for preventing secondary UTIs in young children. Majority of UTIs in children are caused by intestinal bacteria of the patient, mainly E. coli that colonizes gut of the patient. E. coli Nissle is a probiotic strain that has been used successfully for treating acute gastrointestinal infections in children. The strain has also been proved to be safe for infants and young children. E. coli Nissle could be a potential solution for preventing recurrent urinary tract infections in children as it competes with pathogenic bacteria that usually cause UTIs in children. The aim of this study is to evaluate efficacy of E. coli Nissle strain in secondary prevention of urinary tract infections in young children.
The aim of this study is to compare the efficacy of continuous ibrutinib monotherapy with fixed-duration venetoclax plus obinutuzumab and fixed-duration ibrutinib plus venetoclax by measuring progression-free survival (PFS) in patients with previously untreated CLL.