Dammam

Researchers are evaluating the safety and effects of marstacimab, a study medicine, for potential treatment of hemophilia in boys and male children aged 1 to 17 years. The trial focuses on those with severe Hemophilia A or moderately severe to severe Hemophilia B, including participants with or without inhibitors. The study aims to compare participants experiences with marstacimab to their historical bleeding episodes without the medicine. All participants will receive weekly subcutaneous injections of marstacimab. The first dose is administered at the study site by staff, and subsequent doses can be given at home or by study staff during the 12-month treatment period. Enrollment opens sequentially by age groups, starting with adolescents 12-17 years, followed by children 6-11 years, and finally children 1-5 years. The study includes about 1 month of screening, 12 months of treatment, and 1 month of follow-up. Participants will visit the study site at least 10 times during the study, with the option for two visits to occur at home if allowed. They will also receive six phone calls approximately every two months. Researchers will monitor bleeding rates, adverse events, injection site reactions, and immune responses. The overall participation lasts about 14 months, including screening, treatment, and follow-up periods.

Researchers are evaluating the efficacy and safety of elecoglipron, an oral tablet taken once daily, for weight management in adults with obesity or overweight. This Phase III global, randomized, double-blind, placebo-controlled trial includes two independent pivotal studies one in adults without type 2 diabetes T2DM and the other in adults with T2DM, all having at least one weight-related health condition. The goal is to understand how elecoglipron compares to placebo when combined with diet and exercise. Participants will be randomly assigned to receive either one of two doses of elecoglipron or a matching placebo daily. Study 1 involves about 3000 adults living with obesity or overweight without T2DM, while Study 2 involves about 1500 adults with obesity or overweight and T2DM. Both studies last 72 weeks, during which changes in body weight and other health measures will be monitored. During the trial, participants will undergo regular health assessments including measurements of body weight, waist circumference, blood sugar control, blood pressure, and other related health indicators. Researchers will track percent change in body weight from baseline at 72 weeks as the primary outcome. Participants will be monitored closely throughout the study to assess safety and effectiveness of the treatment in managing weight and associated health conditions.

Diffuse large B-cell lymphoma DLBCL is the most common and aggressive subtype of non-Hodgkin lymphoma, with rapid tumor growth and symptoms varying by tumor location. The disease is classified using advanced methods like immunohistochemistry and molecular testing to guide prognosis and personalized treatment. Despite standard immunochemotherapy curing 60-70% of patients, many experience treatment failure or relapse, and options after second-line therapies remain limited. This observational study examines treatment patterns, demographic, and clinical characteristics of DLBCL patients in the Middle East and Africa. It includes two patient groups those newly diagnosed and eligible for treatment, and those with relapsed or refractory DLBCL who have failed previous therapies. The study aims to explore access to novel therapies and understand real-world treatment approaches in these regions. Participants will be observed over 22 months, during which researchers will document treatment regimens, patient risk profiles, and access to new treatments. Data collection includes patient demographics, disease characteristics, and treatment outcomes. The study does not involve experimental treatments but gathers detailed information to inform future care strategies for DLBCL patients.

Researchers are evaluating the combination of baxdrostat and dapagliflozin in people with chronic kidney disease CKD and high blood pressure hypertension. This Phase III, double-blind, placebo-controlled study aims to assess whether this combination reduces the risk of serious kidney damage, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes participants with CKD and hypertension who meet specific kidney function and blood pressure criteria. Participants who are not already taking SGLT2 inhibitors will first complete a 4-week dapagliflozin run-in period. Then, they will be randomly assigned to receive either baxdrostat plus dapagliflozin or a placebo plus dapagliflozin. Baxdrostat dosing may start low and be increased if needed. Study visits will occur at 2, 4, 8, 16, 34, and 52 weeks after randomization, and then approximately every four months until the study ends, which is based on the number of key kidney or heart-related events. Throughout the study, participants will have regular assessments including blood tests to monitor kidney function and potassium levels, blood pressure measurements, and evaluations of heart and kidney health. If participants stop the blinded study drug early, they will continue dapagliflozin if possible and remain in the study for ongoing visits and monitoring. The main outcome is whether the combination treatment reduces the risk of a 50% sustained decline in kidney function, kidney failure, heart failure events, or cardiovascular death over up to 37 months.

This research aims to evaluate how a robotic mental health simulation can improve professional identity, interpersonal communication skills, and emotional intelligence among nursing students in Saudi Arabia. The study focuses on undergraduate nursing students enrolled in a psychiatric-mental health nursing course, addressing the need for enhanced skills in therapeutic relationships and emotional awareness in mental health nursing. The study uses a quasi-experimental design with pre-test, post-test, and three-month follow-up assessments to measure both immediate and sustained effects of the intervention. Participants are divided into two groups an intervention group that engages in structured simulation sessions with a robot portraying patients with psychiatric conditions, and a control group receiving traditional teaching methods without robotic simulation. The simulation includes scenarios involving anxiety, depression, psychosis, emotional distress, and aggressive behavior, with each session comprising pre-briefing, active interaction, and faculty-guided debriefing to support learning and reflection. During the study, participants complete validated self-report measures on professional identity, communication competence, and emotional intelligence before the intervention, immediately after, and at three months post-intervention. The study monitors attendance and completion of assessments to evaluate the educational impact of the robotic simulation. Findings will help determine the value of this innovative teaching method in preparing future nurses with essential psychological and interpersonal skills.

Researchers are evaluating roxadustat, an oral medicine, for treating anemia in children and teenagers with chronic kidney disease CKD. Anemia involves low red blood cell levels, and current treatments often use injections called erythropoietin stimulating agents ESAs with iron, but these have safety concerns. This Phase 3 open-label study aims to understand how roxadustat affects anemia in this young population, offering a potential alternative to ESA injections. Participants will take roxadustat orally or via gastric tube three times a week for up to 52 weeks. The study begins with a fixed dose for 4 weeks, during which blood hemoglobin levels are regularly checked to adjust dosing as needed to maintain target levels just below normal. The study starts with 10 teenagers and 10 children who receive fixed doses to determine appropriate dosing for others. After this, the remaining children and teenagers will take the optimized dose. Children and teenagers will visit the clinic frequently every 2 weeks during the first month and then every 4 weeks until the treatment ends, with a final visit 4 weeks after stopping roxadustat. At visits, vital signs, fluid status for dialysis patients, blood and urine tests, and medical exams will be conducted, including electrocardiograms at specific intervals. Researchers will monitor hemoglobin, iron levels, safety, growth, and quality of life over the study period, which may last up to 56 weeks including follow-up.

Researchers are observing patients with mild to moderate bronchial asthma to understand how often and for how long they need to increase their treatment. The study aims to validate criteria that identify when patients should step up their asthma treatment. Participants continue their current asthma treatment based on established guidelines while the researchers track their symptoms and lung function over time. Participants will maintain their usual asthma treatment and will attend regular study visits for examinations and lung function tests, including spirometry. They will also keep records of their symptom scores, use of rescue inhalers, and morning and evening peak expiratory flow. This data will help assess treatment adjustments in real life. Throughout the 52-week study period, participants will be monitored for how frequently they step up or step down their asthma treatment, the rate of severe asthma attacks, and the number of weeks they maintain asthma control. Researchers will gather this information through regular visits and symptom tracking to better understand asthma management. The study is sponsored by Ain Shams University and includes participants aged 12 to 80 years.

Researchers are investigating the efficacy and safety of golcadomide combined with rituximab compared to investigators choice treatments in adults with relapsed or refractory follicular lymphoma who have received at least one prior systemic therapy. This multicenter, randomized, open-label Phase 3 study focuses on participants with confirmed follicular lymphoma that has returned or not responded to previous treatments, aiming to better understand treatment options in this setting. Participants will be randomly assigned to receive either golcadomide plus rituximab or one of the investigators chosen regimens, which may include rituximab combined with lenalidomide, R-CHOP chemotherapy rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisoneprednisolone, or rituximab with bendamustine. Each treatment involves specified doses on specified days, and the study compares these approaches over a treatment period. During the study, participants will be closely monitored through evaluations such as imaging scans, pathology reviews, and quality of life questionnaires. Researchers will assess progression-free survival up to approximately 32 months, along with other measures like overall response rate, overall survival, duration of response, and minimal residual disease status. Safety and treatment effects will be tracked, and participants may be followed for up to nearly seven years to gather comprehensive outcome data.

Researchers are comparing the effectiveness of two different combinations of immunotherapy drugs with chemotherapy for adults with stage IV or recurrent non-squamous non-small cell lung cancer that has PD-L1 expression of 1% or higher. This phase 3, randomized study focuses on participants who have not previously received systemic treatment for advanced disease. The goal is to determine which combination better improves overall survival and other outcomes in this patient group. Participants will be randomly assigned to receive either Nivolumab plus Relatlimab combined with chemotherapy or Pembrolizumab combined with chemotherapy. The chemotherapy drugs used include Carboplatin, Pemetrexed, or Cisplatin, given in specified doses on scheduled days. Treatment is given as first-line therapy for their cancer, with dosing details managed throughout the study period. During the study, participants will undergo imaging scans like CT or MRI to measure disease status, and blood tests to monitor safety and side effects. The main outcome measured is overall survival over up to five years, along with progression-free survival, response rates, duration of response, and adverse events. Researchers will also assess symptoms related to lung cancer over two years. Participants are monitored regularly to track these outcomes and ensure safety throughout the study duration, which may last several years.

Researchers are evaluating the effects of a medicine called BI 764198 in adults and adolescents who have a kidney condition known as focal segmental glomerulosclerosis FSGS. This Phase 3 clinical trial aims to determine whether BI 764198 helps improve kidney function in people with primary FSGS or genetic FSGS linked to TRPC6 gene variants. The study is randomized and placebo-controlled, meaning participants are randomly assigned to receive either the medicine or a placebo, and neither the participants nor the researchers know which treatment each person receives. Participants take either BI 764198 tablets or placebo tablets once a day for up to two years, while continuing their usual medication for FSGS. The study involves two groups running in parallel. The main treatment period lasts 104 weeks about two years, during which the participants regularly visit the study site approximately every three months. Both groups are compared to see if BI 764198 affects kidney protein levels and function. During the study, participants provide urine samples regularly to assess their kidney health. Researchers measure changes in urine protein-creatinine ratio and kidney filtration rate from the start to the end of the treatment period. Questionnaires about health-related quality of life are also completed. Doctors monitor participants health and note any side effects throughout the two years. This thorough follow-up helps understand how BI 764198 impacts kidney disease and overall well-being.