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Researchers are evaluating a master protocol designed to improve survival and quality of life for infants, children, and young adults aged 0 to 45 years who have been newly diagnosed with acute lymphoblastic leukemia ALL. This observational pilot study collects data from multiple well-known study groups, combining their experience into a comprehensive system for stratifying and treating ALL within this age group. The study aims to optimize diagnostics, registration systems, and collaborative logistics before the main study begins, focusing on standard of care treatments included in the master protocol. The study does not involve specific experimental interventions but serves as a platform for personalized risk-based diagnosis and treatment approaches. It includes standard treatments delivered at participating pediatric oncology or adult hematology centers in the involved countries. High-risk patients may be considered for specialized therapies such as Chimeric Antigen Receptor T-cell CAR-T therapy as an alternative to more intensive treatments to reduce side effects. The platform supports randomized and non-randomized interventions and translational research within the collaboration. Participants will be monitored through regular clinical assessments, with data collected on event-free survival and overall survival compared to historical controls over five years. The study involves confirmation of diagnosis by accredited laboratories, ongoing treatment at participating centers, and adherence to protocol procedures. This pilot phase focuses on collecting data and preparing the infrastructure for future randomized trials and extended research. Participants remain under their usual care throughout the study period, which spans several years for outcome evaluation.

This research aims to improve treatment and survival quality for infants, children, and young adults aged 0 to 45 years with acute lymphoblastic leukaemia ALL. It combines experiences from multiple European study groups into a master protocol that offers comprehensive risk stratification and treatment plans. The study includes randomized and interventional trials to identify therapies that may be less toxic and more effective, particularly focusing on reducing relapse and treatment-related side effects. Participants receive treatment based on a master protocol considered standard care, with additional randomized interventions testing modifications like reducing or omitting specific chemotherapy drugs such as Doxorubicin, Vincristine, and Dexamethasone. Some patients receive experimental treatments including Inotuzumab ozogamicin, Imatinib, 6-tioguanine, and Blinatumomab. Specific sub-studies also examine pharmacokinetics, neurocognitive outcomes, and cerebrospinal fluid diagnostics. The study design allows modular addition or stopping of sub-protocols and interventions. Throughout the study, participants undergo various assessments including monitoring of disease progression, side effects, and drug activity. Researchers evaluate event-free survival, disease-free survival, minimal residual disease response, and overall survival over multiple years, with follow-up periods extending up to 8 years. Participants cognitive functions and treatment toxicities are also assessed using specialized tests and questionnaires. Safety and adverse events are closely monitored to better understand treatment impacts over time.

This study evaluates the long-term safety and tolerability of pelacarsen TQJ230 in people with established cardiovascular disease and elevated Lipoproteina who completed a previous related study. It is an open-label extension trial, meaning all participants receive the study drug without placebo comparison. The trial is sponsored by Novartis Pharmaceuticals and focuses on continued treatment after the completion of the parent study. Participants receive monthly injections of pelacarsen 80 mg subcutaneously for up to 36 months during this extension phase. This phase is designed to provide access to the study drug after the initial trial and to monitor participants closely. The study does not involve randomization or blinding, and all enrolled participants receive the active drug. During the study, participants will undergo regular assessments including monitoring for adverse events and cardiovascular events, as well as measuring Lipoproteina levels at baseline and several time points over 36 months. Safety and tolerability will be closely tracked throughout the treatment period. The total duration of participation corresponds to the length of the extension phase, up to three years.

Researchers are studying metastatic breast cancer in a program aiming to recruit 1300 patients from hospitals across Europe. Eligible participants are adults aged 18 or older, male or female, with a recent diagnosis of metastatic or locally advanced breast cancer or disease relapse who have not received more than one type of treatment for metastases. The goal is to better understand genetic changes in metastatic breast cancer and discover how tumors respond or resist therapy to eventually identify the most suitable treatment for each patient. The study is sponsored by the Jules Bordet Institute and focuses on molecular analysis of cancer samples. Participants will undergo a biopsy of a metastatic lesion either at program entry or up to six months before inclusion, and a sample of the primary tumor must be available. Blood, serum, and plasma samples will also be collected. These samples will be analyzed centrally, and any unused samples will be stored in a bio-repository for future research. The study offers the possibility for patients with certain genetic changes to join related clinical trials if available and approved in their country. Throughout the study, participants provide blood samples at screening and regular intervals during follow-up. Researchers will evaluate genetic alterations, identify exceptional responders and rapid progressors, and assess patient prognosis over up to 10 years. The study will also monitor the feasibility of molecular screening and correlate molecular findings with standard measures of treatment response. The total study duration extends to March 2031, with primary outcome review planned one year after recruitment ends.

Bipolar disorder affects 1-3% of people worldwide and involves 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 depression. Behavioral activation therapy BA, proven effective for unipolar depression, aims to help people restore healthier activity patterns and improve mood stability in bipolar disorder. This study evaluates the feasibility and pilot effectiveness of BA adapted for bipolar depression BA-BD among people seeking treatment at a specialized bipolar disorder service. Participants will receive up to 20 individual sessions of BA-BD therapy, each about 50 minutes, plus one booster session three months after therapy ends. The study uses a randomized wait period design where participants start therapy after waiting 2, 3, 4, or 5 weeks from baseline assessment. BA-BD is provided alongside usual treatment to see if it can be effectively integrated as an additional therapy for bipolar depression. During the study, participants complete regular questionnaires and interviews to assess changes in depression symptoms, activity levels, and sleep using health devices. Researchers will monitor therapy uptake, completion rates, and any adverse reactions over an average of 7 months. Various scales measuring mania, depression, anxiety, quality of life, and behavioral activation will be used to evaluate outcomes and safety throughout the study period.

Researchers are evaluating a new treatment approach for patients with recurrent non-muscle invasive bladder cancer, specifically those with Ta low-grade tumors that have returned after previous treatment. This randomized, multinational Phase 4 study aims to compare the long-term effectiveness of dose-dense chemoablation using Mitomycin C MMC combined with adjuvant BCG against the current standard treatment involving transurethral resection of bladder tumors TURBT and intravesical instillation therapy. The study follows previous promising findings from the NICSA trial and seeks to improve clinical outcomes by tailoring treatment to patient response. Participants in the experimental group will receive MMC chemoablation three times a week for two weeks six total instillations, followed by a cystoscopy eight weeks later. Those who show complete tumor response will continue with monthly MMC maintenance instillations for six months before joining regular follow-up care. Patients without complete response will undergo TURBT or biopsy with tumor fulguration, followed by adjuvant BCG induction and maintenance therapy. The control group will receive TURBT or biopsy followed by standard intravesical therapy MMC weekly for six weeks plus monthly maintenance for low-grade tumors or BCG weekly for six weeks plus one-year maintenance for high-grade tumors. During the study, participants will be monitored for tumor recurrence through cystoscopies and other assessments over two and five years. Researchers will measure outcomes such as two-year and five-year recurrence-free survival, progression-free survival, overall survival, the number of surgeries required, and serious adverse events related to MMC treatment. The trial will last several years, with long-term follow-up to understand how well the treatments prevent tumor return and improve patient outcomes.

Researchers are evaluating the benefits and risks of using furosemide, a diuretic, compared to a placebo in critically ill adult patients who experience fluid overload in the intensive care unit ICU. Fluid overload, a common complication in ICU patients, can worsen outcomes especially in those with acute kidney injury. The study aims to determine if reducing excess fluid with furosemide improves patient health or if fluid overload is simply a marker of severe illness. Participants are randomly assigned to receive either furosemide or a placebo isotonic saline through intravenous infusion. The furosemide group receives a bolus dose followed by an infusion adjusted to target a negative fluid balance of 1 ml per kg per hour, with fluid balance monitored three times daily. The placebo group receives saline dosed and adjusted by the same protocol. Treatment continues until the excess fluid is removed and fluid balance is neutral. During the study, participants will be closely monitored for fluid balance and clinical stability. Researchers will assess outcomes including days alive and out of hospital within 90 days, mortality rates up to one year, serious adverse events, quality of life, and cognitive function. The study involves a randomized, blinded design to compare the effects of furosemide versus placebo over a one-year follow-up period.

Researchers are evaluating the effect of Sidekick Healths digital program on self-efficacy and medication adherence in women diagnosed with breast cancer who are prescribed adjuvant anti-hormonal treatment. This randomized, controlled trial compares the digital patient support program plus standard of care with standard of care alone. The study aims to support breast cancer patients in managing symptoms and improving medication adherence during their endocrine treatment. Participants are randomly assigned to one of two groups one group uses the Sidekick Health app alongside their standard breast cancer treatment, while the other group receives only the standard care. The digital program includes a medication center with behavioral change materials, gamification, rewards, and engaging tasks to promote self-efficacy and healthy lifestyle changes. Both groups receive the usual adjuvant treatment and any optional cancer rehabilitation not delivered through an app. Throughout the study, participants will be monitored for their self-efficacy and medication adherence at 12 weeks, 24 weeks, and one year. Researchers will collect data on medication persistence, physical activity, body mass index, symptom management, quality of life, and user satisfaction with the app. The study includes follow-up assessments up to five years to evaluate adherence and long-term outcomes. Participants will complete questionnaires and in-app reports, and their engagement with the digital program will be tracked.

This research aims to explore how emotion regulation affects treatment outcomes in children aged 6 to 12 years diagnosed with Oppositional Defiant Disorder ODD. It focuses on whether matching treatment to a childs level of emotion regulation difficulty can improve results. The study divides participants into two groups based on their emotion regulation skills high emotion dysregulation and low emotion dysregulation. It then compares the effects of two treatments within these groups. Participants will receive one of two types of behavioral interventions. One is a parent management training program designed to help parents increase compliance and reduce disruptive behaviors in their children. The other is a child-directed cognitive behavioral therapy called Tuning Your Temper, which focuses on problem solving, emotion regulation, and reducing arousal. Treatments are given in individual sessions, and children are randomly assigned to one of the two treatments within their emotion regulation group. Children will be assessed before and after treatment, as well as at 6 and 18 months follow-up. Researchers will use rating scales and structured interviews to measure disruptive behavior, emotional symptoms, social skills, parental stress, and quality of life. Comorbid conditions will also be evaluated as possible factors influencing treatment effects. The total study period includes treatment and long-term monitoring to understand how well the interventions work over time.

Researchers are evaluating three different methods to create unexpected disturbances during walking, aiming to better understand balance and fall prevention. The study includes two groups people who use prosthetic limbs and able-bodied individuals. The goal is to assess how these methods can simulate stumbles or slips to study adaptive walking responses. Participants will undergo tests where controlled disturbances are introduced using up to four different techniques, such as obstacles placed on or near a treadmill and a device that induces slipping. The number of methods used per session depends on time and participant fatigue. Both groups will experience these tests to compare responses. During each testing session lasting about 30 to 60 minutes, researchers will observe how often stumbles or falls occur with each method. Participants will provide feedback on how effective, safe, unpredictable, and consistent these perturbation methods feel. The study will monitor these outcomes within the same session to understand gait adaptability and safety perceptions.