Berkeley

This research aims to compare two approaches for treating previously untreated amblyopia in children aged 3 to under 13 years. It evaluates whether using glasses and patching at the same time leads to similar improvements in vision as first using glasses alone, followed by patching only if needed. The trial focuses on children with amblyopia caused by differences in eye alignment or prescription errors. Children will be assigned randomly to one of two treatment groups one group will wear glasses full-time and add patching for 2 hours daily only if there is no improvement after glasses alone the other group will wear glasses and patch the weaker eye for 2 hours daily at the same time from the start. Vision tests will be done at baseline and follow-up visits every 8 weeks for up to 56 weeks. Participants will have their distance visual acuity measured with trial frames before and after getting their glasses to confirm eligibility. During the study, vision will be monitored to classify improvement or stability, guiding whether patching is needed in the sequential group. Outcomes include changes in vision clarity after 56 weeks and quality-of-life assessments. Regular visits help track progress and safety until study completion.

Researchers are evaluating elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

Researchers are evaluating nemtabrutinib compared with investigators choice of ibrutinib or acalabrutinib in adults with untreated chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL. The study aims to assess whether nemtabrutinib is not worse than these comparators in terms of objective response rate and whether it can provide longer progression-free survival. This is a Phase 3 randomized clinical trial sponsored by Merck Sharp & Dohme LLC. Participants will receive either nemtabrutinib, ibrutinib, or acalabrutinib orally at specified doses until their disease progresses, unacceptable side effects occur, or other discontinuation criteria are met. The trial uses a parallel-group design where participants are randomly assigned to one of the treatment groups, and no masking is involved. Both treatment arms continue until progression or intolerance. During the study, participants will be monitored regularly up to about 33 months for response rate and up to about 104 months for progression-free survival and overall survival. Assessments include clinical evaluations, safety monitoring for adverse events, and duration of response measurements. The study tracks treatment tolerability, discontinuations due to adverse events, and overall outcomes to better understand the therapies effects in this patient population.

Researchers are evaluating the effectiveness of glofitamab alone compared to an investigators choice of treatments for adults with relapsed or refractory mantle cell lymphoma MCL. This phase III trial focuses on patients whose lymphoma has returned or not responded after previous treatments, including those who have received BTK inhibitors. The study aims to determine which treatment better controls the disease and improves patient outcomes. Participants in the glofitamab group will first receive two intravenous doses of obinutuzumab before starting glofitamab infusions every 21 days for up to 12 cycles. Those in the comparison group will receive either bendamustine plus rituximab for up to six 28-day cycles or rituximab combined with daily oral lenalidomide for 28-day cycles until their disease progresses. Tocilizumab may be given intravenously as needed to manage side effects like cytokine release syndrome. Throughout the study, participants will undergo regular assessments including scans to measure tumor size, blood tests, and quality of life questionnaires. The main measure is progression-free survival up to about 24 months, with additional evaluations of response rates, overall survival, symptom changes, and drug levels. Safety monitoring and long-term follow-up will occur during this period to track treatment effects and patient well-being.

Researchers are evaluating the study medicine PF-08046054 compared to the standard treatment docetaxel in adults with non-small cell lung cancer NSCLC that has PD-L1 expression of 1% or higher. These participants have cancer that has spread or cannot be treated with surgery or definitive radiation and have shown disease progression during or after previous treatments including PD-L1 or PD-1 inhibitors, platinum-based chemotherapy, and targeted therapies for known genomic alterations. The study is a randomized phase 3 trial assessing treatment options for advanced NSCLC. Participants are randomly assigned to one of two groups one receives PF-08046054 as an intravenous IV infusion twice during each 21-day cycle, and the other receives docetaxel as an IV infusion once every 21 days. The study treatment may continue for up to 5 years if the participants cancer responds to therapy. Both treatments are given in cycles, and participants receive the medicine through infusions during clinic visits. During the study, participants will have regular clinic visits to monitor their health and how well the treatment is working. Assessments include measuring overall survival, progression-free survival, tumor response rates, and quality of life through questionnaires. Safety is monitored for adverse events up to 90 days after treatment ends. Blood samples are also taken to study the medicines levels and immune response. The total study duration can be up to 5 years depending on individual responses and outcomes.

Researchers are evaluating whether adding the immunotherapy drug durvalumab to the usual chemotherapy regimen can improve outcomes for patients with MammaPrint High 2 Risk MP2 stage II-III hormone receptor positive, HER2 negative breast cancer. This phase III trial focuses on comparing breast cancer event-free survival and other measures between patients receiving chemotherapy alone and those receiving chemotherapy with durvalumab. Immunotherapy may help enhance the bodys immune response against cancer, while chemotherapy works to stop tumor growth in various ways. Participants are first tested for MP2 status using MammaPrint on previously collected tissue. Those with MP2 results are randomized into two groups. One group receives paclitaxel intravenously on days 1 and 8 every 14 days for six cycles, followed by doxorubicin and cyclophosphamide intravenously every 14 days for four cycles. The other group receives the same chemotherapy schedule combined with durvalumab given intravenously over 60 minutes on specific cycles. Mammography and optional tumor tissue and blood sample collections occur during the study. During the study, participants undergo assessments including mammography, tumor biopsies, blood tests, and quality-of-life questionnaires. Researchers measure outcomes such as event-free survival, response rates, relapse-free survival, overall survival, treatment side effects, and patient-reported fatigue and physical health. After treatment completion, participants are followed for up to 10 years to monitor long-term outcomes and survival. Specimens are also banked for future research.

Researchers are studying heavy drinking young adults aged 18 to 26 to see how brief training in craving regulation affects alcohol consumption. This Stage 1B randomized controlled trial compares two active training methods based on cognitive-behavioral therapy CBT and mindfulness-based therapy MBT with a control group receiving no strategy. The study aims to understand if these approaches can reduce heavy drinking and related negative consequences. Participants are randomly assigned to one of three groups CBT-ROC-T training, MBT-ROC-T training, or a control group with no craving regulation strategy. Each participant will complete four 45-minute web-based sessions over three weeks. The study spans 16 weeks, including three weeks before intervention, three weeks during intervention, and ten weeks after intervention. Participants will undergo screening by phone and online, followed by in-person eligibility confirmation and baseline assessments. Throughout the study, they will complete training sessions, post-intervention assessments, and 1-2 follow-up assessments via phone or online. Researchers will measure changes in heavy drinking frequency, estimated blood alcohol concentration, alcohol-related negative consequences, and WHO drinking risk levels. Data will be collected using craving ratings and questionnaires during exposure to alcohol-related stimuli.

Researchers are evaluating the effects of a high-intensity exercise program specifically designed for individuals with chronic post-stroke aphasia. This randomized trial aims to determine whether participating in this program leads to improvements in physical health, language, cognitive, motor recovery, psychological, and psychosocial areas compared to a low-intensity exercise program. The study will assess both short- and long-term effects over several months. Participants will be randomly assigned to one of two groups one group will engage in a 12-week high-intensity interval training full-body workout called Aphasia Physical EXercise APEX, tailored to accommodate stroke survivors motor abilities and fitness levels. The other group will participate in a 12-week low-intensity non-aerobic exercise program that reflects standard physical therapy without cardiovascular or strengthening components. Both interventions are delivered in group settings. During the study, participants will undergo evaluations at multiple time points, including baseline, pre-treatment, post-treatment, and a 3-month follow-up. Assessments include language testing with the Western Aphasia Battery and other language and cognitive tests, physical fitness measures like aerobic capacity and gait speed, as well as motor performance and functional tests. Researchers will monitor changes in these areas to understand the impact of the exercise programs on recovery after stroke.

Researchers are studying the effects of adding olaparib, a PARP inhibitor, after surgery and chemotherapy in patients with pancreatic cancer that has been surgically removed and who have mutations in BRCA1, BRCA2, or PALB2 genes. This phase II trial aims to see if olaparib can improve relapse-free survival compared to placebo. The study also evaluates overall survival and differences in outcomes based on mutation type and prior chemotherapy treatment. Participants are randomly assigned to receive either olaparib or a placebo orally twice daily in 28-day cycles for up to 12 cycles, unless the disease progresses or side effects occur. During the treatment, patients will have CT or MRI scans and blood samples taken regularly. After treatment, participants will be followed up at 30 days, every 4 months for the first year, then every 6 months for up to 10 years. Throughout the study, patients will undergo imaging and blood tests to monitor their health and detect any recurrence of cancer. The main outcome measured is the time from randomization to disease recurrence or death. Researchers will also track overall survival for up to 10 years. Safety will be monitored, and participants will be observed regularly after treatment to assess long-term effects and disease status.

This research aims to evaluate the effects of a multi-component chlorination intervention on maternal and neonatal health in public healthcare facilities in western Kenya. The trial focuses on reducing bacterial contamination and antibiotic-resistant infections in neonates born at these facilities. The study is a cluster randomized controlled trial involving 36 health facilities, with a goal to provide evidence on how chlorinated water supply and reliable chlorine disinfectant use impact bacterial contamination and infection rates. Health facilities will be randomly assigned either to a control group or to an intervention group. Intervention facilities will receive passive inline chlorine dosers that automatically treat water used in maternity wards, along with a steady supply of chlorine disinfectant. Half of the intervention sites will produce chlorine on-site using electrochlorinators, while the other half will receive bulk chlorine deliveries. Both intervention and control facilities will receive infection prevention and control messaging. Facilities will also get equipment like mops and spray bottles for surface cleaning. Participants include pregnant adults or mature minors giving birth at enrolled facilities and their newborns. Researchers will collect data over 24 months, assessing bacterial contamination in water, on hands, and on surfaces, as well as gut colonization by pathogenic and antibiotic-resistant bacteria in mothers and neonates. Health outcomes like possible serious bacterial infection and sepsis symptoms will be monitored during the first week after birth. The study will also track neonatal and maternal mortality up to 28 days postpartum to understand the interventions impact on infection and health.