Reykjavik

Researchers are evaluating a new comprehensive treatment protocol for infants, children, and young adults aged 0 to 45 years with acute lymphoblastic leukemia (ALL). This pilot study collects data from successful treatments used by various well-known study groups and aims to improve survival and quality of life by using a personalized risk-based approach. The study involves countries and groups preparing to join the ALLTogether1 collaboration and focuses on optimizing diagnostic, registration, and treatment systems before the main study begins. The study is observational and does not include any experimental interventions; it follows the standard of care outlined in the master protocol. Treatment decisions are based on a novel personalized algorithm considering clinical features, genetic changes in leukemia, and therapy response. High-risk patients may be offered Chimeric Antigen Receptor T-cell (CAR-T) therapy as an alternative to intensive treatments to reduce side effects. The protocol also supports adding randomized and non-randomized interventions and translational research. Participants will be diagnosed and treated at specialized pediatric or adult hematology centers in participating countries. The study involves collecting diagnostic and treatment data, with follow-up over five years to measure event-free survival and overall survival compared to historical controls. Safety and quality of survival will be monitored through this long-term observation, helping to refine treatment approaches and support future research collaborations.

This research evaluates treatments for acute lymphoblastic leukemia (ALL) in infants, children, and young adults up to 45 years old. It combines successful approaches from multiple European study groups into a master protocol with several randomized and interventional sub-studies. The goal is to improve survival rates while reducing treatment toxicity and relapse, especially focusing on better risk stratification and targeted therapies for different patient groups, including those with genetic differences and high relapse risk. The study uses a master protocol considered as standard care, with additional randomized interventions testing if treatment can be safely reduced in some risk groups or improved with new therapies in higher risk groups. Randomizations include testing omission of drugs like Doxorubicin or Vincristine+Dexamethasone pulses, adding Inotuzumab ozogamicin or 6-tioguanine to maintenance therapy, and treating certain patients with tyrosine-kinase inhibitors or Blinatumomab. The design allows flexible addition or stopping of sub-studies, and some interventions target specific patient subgroups such as those with ABL-class fusions or Down syndrome. Participants will undergo diagnosis confirmation and follow-up at participating centers and receive assigned treatments based on risk and randomization. Researchers monitor event-free survival, disease-free survival, and minimal residual disease response up to 5 to 8 years. Additional assessments include neurocognitive testing, pharmacokinetics of drugs like Imatinib and Asparaginase, cerebrospinal fluid analysis, and quality of life evaluations. Safety and long-term outcomes are closely tracked, with at least 5 years of follow-up for most measures.

Researchers are studying metastatic breast cancer by recruiting 1300 patients from many hospitals across Europe. This study focuses on patients aged 18 or older, both female and male, who have been diagnosed with metastatic breast cancer or a relapse and have not received more than one systemic treatment since the discovery of metastases. The main goal is to better understand the genetic changes in metastatic breast cancer and how patients respond or resist therapies, aiming to find the right treatment for each patient. Patients with genetic changes that match new drug trials may have the option to participate in those trials if available. Participants undergo a biopsy of the metastatic lesion to collect tissue samples, performed by a surgeon or radiologist. Biopsy samples, along with blood, serum, and plasma, are collected both at the start and during follow-up. Some samples are analyzed immediately, while others are stored in a bio-repository for future research. Biopsies can be from bone or brain tissue under specific conditions, and must be collected before starting or changing systemic treatment lines, following precise timing rules. Throughout the study, participants provide regular blood samples and allow collection of tissue samples from both primary and metastatic tumors. Researchers monitor participants' health status and treatment responses. The primary outcome is to improve understanding of metastatic breast cancer over the year following the end of patient recruitment. This research aims to enhance treatment outcomes for all patients diagnosed with metastatic breast cancer by using detailed molecular analyses and offering access to clinical trials when possible.

Researchers are studying how a repetitive negative thinking style called depressive rumination, which can contribute to depression, changes during Behavioral Activation (BA) treatment for people currently experiencing major depression. This study aims to understand if mood-reactive rumination habits change with BA treatment and if these changes relate to improvements in symptoms. The study will also explore how factors like early life stress and cognitive flexibility affect treatment outcomes. Up to 120 adults with major depressive disorder will participate in this research. Participants will receive individual Behavioral Activation therapy over 12 sessions spread across 11 weeks. This psychological treatment focuses on helping individuals gradually re-engage with rewarding activities and reduce avoidance behaviors. All participants receive the same BA treatment, with essential components introduced by the eighth session to ensure a minimum treatment dose. Assessments occur before treatment, during treatment sessions and at two specific times after sessions 4 and 8, at the end of treatment, and again 6 months later. Throughout the study, participants will complete various evaluations including clinician interviews, self-report questionnaires, experimental tasks, and assessments via smartphone to track moment-to-moment changes in daily life. Researchers will measure symptom severity, diagnostic status, rumination patterns, perceived control, reward responses, and activity levels. These measurements will help determine the treatment's impact immediately and over the longer term, with careful monitoring of symptom changes and behavioral patterns during and after therapy.

Bipolar disorder affects about 1-3% of people worldwide, causing episodes of mania or hypomania along with periods of depression that can disrupt daily life. While psychological therapies exist for depression without mania, there is limited research on their effectiveness for bipolar disorder. Behavioral activation therapy (BA), proven effective for unipolar depression, aims to help individuals restore healthier activity and sleep patterns, potentially stabilizing mood in bipolar depression. This research seeks to implement and evaluate BA adapted for bipolar depression (BA-BD) in a specialized bipolar disorder service in Iceland. Participants will receive up to 20 individual BA therapy sessions, each about 50 minutes long, plus one booster session three months after therapy ends. BA focuses on encouraging healthy behaviors and reducing avoidance that maintains depression. Therapy is provided alongside usual treatment, with home practice assigned between sessions. This study will include at least ten people currently experiencing bipolar depression and willing to participate. Throughout the average 7-month study, participants will complete regular questionnaires and interviews to assess depression symptoms, therapy uptake and completion, changes in activity and sleep measured by health devices, and monitor any adverse reactions. Researchers will measure whether a majority achieve meaningful improvement in depression and track safety and adherence over the study period.

Researchers are conducting a multinational, randomized Phase 4 study to evaluate treatments for patients with recurrent non-muscle invasive bladder cancer (NMIBC), specifically those with Ta low-grade tumors. The study aims to determine if a dose-dense chemoablation using Mitomycin C (MMC), followed by adjuvant BCG therapy for non-responders, is more effective for long-term recurrence control than the current standard treatment involving transurethral resection of bladder tumors (TURBT) and adjuvant intravesical therapy. This trial builds on prior research that influenced European treatment guidelines and aims to improve outcomes through a personalized approach based on patient response to chemoablation.

Fluid overload is a serious and common problem in adults admitted to the intensive care unit (ICU), often caused by the fluids used during resuscitation. This research aims to understand if removing excess fluid with the drug furosemide improves outcomes compared to a placebo. The study focuses on critically ill adult patients who have gained at least 5% excess fluid relative to their ideal body weight. It is a Phase 4, randomized, blinded, placebo-controlled trial designed to explore the effects of fluid removal on patient health and survival. Participants will be randomly assigned to receive either furosemide, a diuretic drug given by injection or infusion, or a placebo consisting of isotonic saline administered the same way. Treatment will continue until the excess fluid has been removed. The study carefully monitors clinical stability, including blood pressure and medication needs, to ensure safe administration of the treatments. Throughout the study, participants' health will be closely tracked, including days alive and out of hospital within 90 days after randomization. Researchers will assess fluid balance, kidney function, and overall recovery while watching for any side effects or complications. The study also includes strict criteria for patient selection to ensure safety and relevance, with ongoing follow-up to evaluate the impact of fluid removal on critical illness outcomes.

Researchers are evaluating a digital patient support program designed by Sidekick Health to help women with breast cancer improve their confidence in managing symptoms and sticking to their medication routine. This study focuses on women prescribed adjuvant endocrine therapy for breast cancer stages I, II, or III. It is a randomized controlled trial comparing the digital program plus standard care to standard care alone. The digital program is delivered through a mobile app that offers holistic lifestyle support and tools to promote medication adherence. Participants will be randomly assigned to either receive the Sidekick app alongside their usual breast cancer treatment and optional rehabilitation or to continue with standard care only. The study plans to include 140 women who meet the eligibility criteria. During the 12-week study, participants will be monitored to assess changes in self-efficacy and medication adherence. Researchers will collect data on how the digital program impacts patients' confidence in managing their health and their ability to follow prescribed treatment. The study involves regular assessments and requires participants to use the app if assigned to the intervention group, with the goal of understanding the program's effectiveness alongside standard care.

Researchers are evaluating how emotion regulation affects two different treatments for children diagnosed with Oppositional Defiant Disorder (ODD). The study aims to determine whether children with ODD benefit more when their treatment matches their specific emotion regulation difficulties. Children will be grouped into high or low emotion dysregulation categories to explore this question. The study also considers how additional conditions may influence treatment effects. Participants will be randomly assigned within their emotion regulation groups to one of two treatments: a behavioral parent training program designed to increase compliance and reduce disruptive behaviors, or a child-directed cognitive treatment called Tuning Your Temper, which focuses on reducing emotional arousal, problem solving, and cognitive restructuring. These treatments are evaluated to see which works better for children with differing emotion regulation skills. Children will be assessed before treatment, immediately after treatment, and at 6- and 18-month follow-ups. Researchers will use tools like the Disruptive Behaviour Rating Scale and the Schedule for Affective Disorders and Schizophrenia for School Aged Children (K-SADS-PL) to measure treatment outcomes and emotional changes over time. This helps track progress and understand long-term effects of the treatments.

Researchers are evaluating three different methods to create walking disturbances, called gait perturbations, to study stumbles and slips. The study involves two groups: people who use prosthetics and those who are able-bodied. The goal is to understand how these methods mimic unexpected challenges during walking, which may help in fall prevention and balance improvement for individuals with lower limb amputation or balance issues. Participants will experience controlled disturbances while walking on a treadmill. The methods include obstacles placed at the front or side of the treadmill, a spit-bell treadmill that causes slips, and a string method. Each participant will undergo testing sessions lasting about 30 to 60 minutes, with one or more methods tested per session depending on factors like time and fatigue. During the study, researchers will observe how effectively each method causes stumbles or falls and will collect participants' feedback on how safe, unpredictable, and consistent these disturbances feel. The study involves walking tests without assistive devices and includes assessments of mobility, balance, and overall safety perceptions. Participation requires participants to meet eligibility criteria including weight, walking ability, and cognitive function.