Berkeley

Researchers are evaluating the performance of two different polyurethane male condoms with varying sizes and thicknesses compared to a standard natural rubber latex male condom in healthy monogamous couples. The study aims to determine how often each condom type breaks or slips off during vaginal intercourse and to assess how well couples tolerate and like using each condom type. This investigation is designed to provide a comparison of the effectiveness and user experience of these condom types. During the study, couples will use each condom type—two different polyurethane condoms and one latex condom—in a randomized, crossover design. For each condom type, couples will receive between 5 and 7 condoms to use during vaginal intercourse over a maximum 5-week period. Each couple will repeat this assessment period for all three condom types, allowing direct comparison of performance. The study also evaluates tolerance and any problems such as irritation or discomfort during use. Participants will be asked to respond to questionnaires and scales shortly after intercourse to report on condom use and any issues experienced. Researchers will monitor total clinical failure rates, defined as condom breakage or slippage within 8 hours following each sexual act. Couples must have internet access to upload questionnaire data and will be followed up throughout the study. The trial includes detailed assessments of condom performance, user satisfaction, and safety over the course of the investigation.

Researchers are investigating whether treating children with amblyopia using spectacles and patching at the same time leads to similar vision improvement compared to treating first with spectacles alone and then adding patching if needed. This randomized Phase 3 trial focuses on children aged 3 to under 13 years who have not been treated for amblyopia before. The study looks at amblyopia caused by differences in eye focusing (anisometropia), eye misalignment (strabismus), or both. At the start, children's vision will be tested with trial glasses based on a recent eye exam. Eligible children will receive new glasses and return for a baseline visit after wearing them for at least 10 minutes to confirm eligibility. Then they will be randomly assigned to either the sequential group (glasses first, patching added if needed) or the simultaneous group (glasses and patching together). Follow-up visits will happen every 8 weeks for up to 56 weeks, with vision tested each time to track improvement or stability. Patching will be monitored using an occlusion dose monitor (ODM). Throughout the study, vision in the amblyopic eye will be regularly measured to assess changes. Participants will be categorized as improving or stable/worsening at each visit. Those with stable or worsening vision and remaining amblyopia in the sequential group will begin patching and continue follow-up visits. Treatment adjustments will be made based on investigator judgment. The main outcome is the average change in distance visual acuity in the amblyopic eye after 56 weeks of treatment. The study ends after the final 56-week visit.

Researchers are evaluating how well elacestrant works compared to standard endocrine therapy in adults with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer who are at high risk of the cancer returning. This is a Phase 3 global, multicenter, randomized, open-label study focusing on participants who have had early invasive breast cancer removed and meet specific receptor and risk criteria. The study aims to understand which treatment better prevents invasive breast cancer over up to five years. Participants will receive either elacestrant or one of several standard endocrine therapies, including anastrozole, letrozole, exemestane, or tamoxifen, all given as oral tablets. Treatments will be administered according to the study plan, with careful monitoring throughout the trial. The study includes adults who have already received between 24 and 60 months of prior endocrine therapy, with or without certain inhibitors, and who have completed or stopped these treatments as required. During the study, participants will be monitored for invasive breast cancer-free survival for up to five years. Researchers will perform regular assessments to track treatment effects, side effects, and cancer recurrence. The study also includes safety monitoring and may involve additional tests or evaluations as needed to ensure participant well-being throughout the trial.

Researchers are evaluating nemtabrutinib compared with the investigator's choice of ibrutinib or acalabrutinib in adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have not received any prior therapy. This Phase 3 study aims to determine if nemtabrutinib is not worse than ibrutinib or acalabrutinib in terms of objective response rate and if it is better regarding progression-free survival, both assessed using standardized disease criteria by independent review. Participants will be randomly assigned to receive one of the three oral treatments: nemtabrutinib, ibrutinib, or acalabrutinib. The study compares the effectiveness of nemtabrutinib against the other two drugs chosen by the investigator to treat first-line CLL/SLL. Treatment continues with monitoring over months to assess response and disease progression. During the study, participants will undergo evaluations based on the International Workshop on Chronic Lymphocytic Leukemia criteria, including blinded independent central reviews of their disease status. Researchers will track objective response rates up to about 33 months and progression-free survival up to around 104 months. Participants will also be monitored for safety and treatment adherence throughout the trial period.

Researchers are evaluating the effectiveness of glofitamab given alone compared to an investigator's choice of treatment in patients with relapsed or refractory mantle cell lymphoma (MCL). This Phase III, open-label study focuses on patients whose disease has progressed after previous therapies, including BTK inhibitors. The goal is to see which treatment better controls the lymphoma and prolongs the time before the disease worsens or leads to death. Participants are assigned to receive either glofitamab alone or one of two combination therapies selected by the investigator: rituximab plus bendamustine or lenalidomide with rituximab. All patients receive two pretreatments of intravenous obinutuzumab starting on Cycle 1 Day 1. Those in the glofitamab group begin intravenous glofitamab on Cycle 1 Day 8 and continue for 12 cycles, each lasting 21 days. Patients receiving the combination therapies get intravenous rituximab every 28 days, with bendamustine given on Days 1 and 2 of each 28-day cycle for six cycles, or oral lenalidomide daily on Days 1-21 of each 28-day cycle until disease progression. Tocilizumab is available as needed to manage any cytokine release syndrome events. Throughout the study, participants undergo regular assessments to track disease progression, including imaging and laboratory tests. The primary measure is progression-free survival, defined as the time from randomization until disease worsening or death, monitored for up to about 24 months. Safety is closely observed, and patients are evaluated for treatment response and adverse effects. The study involves ongoing monitoring during treatment cycles and follow-up periods to understand the impact of the therapies on the lymphoma and patient health.

Researchers are investigating the addition of an immunotherapy drug called durvalumab to standard chemotherapy treatment in patients with MammaPrint High 2 Risk (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer. This phase III trial aims to compare the effectiveness of usual chemotherapy alone versus chemotherapy combined with durvalumab. Immunotherapy with durvalumab may help the immune system attack cancer cells and prevent tumor growth and spread, while chemotherapy drugs like paclitaxel, doxorubicin, and cyclophosphamide work to stop cancer cells from growing or dividing. Previous studies suggest patients with an MP2 result might respond better to this combined treatment approach. Participants first undergo MammaPrint testing to confirm MP2 status before randomization into two groups. One group receives paclitaxel intravenously on days 1 and 8 every 14 days for 6 cycles, followed by doxorubicin and cyclophosphamide intravenously on day 1 every 14 days for 4 cycles. The other group receives the same chemotherapy schedule plus durvalumab intravenously over 60 minutes on specified cycles during both chemotherapy phases. Mammography is performed during screening, and optional tissue and blood samples are collected for future studies. Throughout the study, participants are monitored through various assessments including imaging, physical exams, laboratory tests, and quality of life questionnaires focusing on fatigue and physical and mental health. Researchers track breast cancer event-free survival and other outcomes such as treatment side effects and response rates. After completing treatment, patients are followed for up to 10 years or until death to evaluate long-term outcomes and safety.

Researchers are evaluating whether brief training in craving regulation can reduce alcohol drinking among heavy drinking young adults aged 18 to 26. This Stage 1B randomized controlled trial focuses on two behavioral treatments: cognitive-behavioral therapy (CBT) and mindfulness-based treatment (MBT). The study aims to see if these training methods affect the frequency of heavy drinking days and estimated blood alcohol concentration over time. Participants are randomly assigned to one of three groups: CBT-based craving regulation training, MBT-based craving regulation training, or a control group with no strategy. Each intervention consists of four 45-minute web-based sessions delivered over three weeks. The training involves viewing alcohol-related images and practicing strategies such as focusing on negative drinking consequences or accepting cravings without judgment. The study enrollment lasts 16 weeks, including three weeks before, three weeks during, and ten weeks after the intervention. Participants complete initial screening by phone and online, attend an in-person visit for eligibility and baseline assessment, and then complete training visits followed by a post-intervention assessment. Follow-up assessments are conducted by phone or online at two weeks and ten weeks after the intervention. Researchers measure changes in heavy drinking frequency, average blood alcohol concentration per drinking day, and craving levels. Participants' adherence and ability to use strategies are monitored throughout the study.

Researchers are evaluating the effects of a high-intensity exercise program specifically designed for individuals with aphasia following a stroke. The study aims to determine whether this exercise program can improve physical health, language abilities, cognitive and motor recovery, as well as psychological and social well-being. Participants have aphasia caused by ischemic or hemorrhagic stroke and must meet certain criteria including being medically stable and able to walk independently. Participants will be randomly assigned to one of two groups for a 12-week intervention: a high-intensity interval training full-body workout called Aphasia Physical EXercise (APEX), designed to improve cardiovascular fitness and muscle strength while accommodating stroke-related motor limitations, or a low-intensity non-aerobic exercise program that serves as an active control resembling standard physical therapy but without cardiovascular or strengthening components. Both interventions are delivered in a group setting. Throughout the study, researchers will measure changes using the Western Aphasia Battery (WAB) Aphasia Quotient at baseline, before treatment, immediately after treatment, and at a 3-month follow-up. Outcome measures will assess language, cognitive, motor, psychological, and physical health domains. The study also includes a 12-week maintenance period to observe longer-term effects, with safety and medical stability monitored during the participation.

Researchers are evaluating the addition of olaparib, a PARP inhibitor, as maintenance therapy following surgery and chemotherapy in patients with pancreatic cancer that has been surgically removed and who have a pathogenic mutation in BRCA1, BRCA2, or PALB2 genes. This phase II randomized, double-blind study aims to determine if olaparib can improve relapse-free survival compared to placebo in these patients, who have completed perioperative chemotherapy and have no evidence of recurrent disease. Participants are randomly assigned to receive either olaparib or a placebo orally twice daily in 28-day cycles for up to 12 cycles, as long as there is no disease progression or unacceptable side effects. Throughout the treatment period, patients undergo imaging tests such as CT scans or MRI and blood sample collections. After completing the treatment cycles, patients are followed up at 30 days, every 4 months for the first year, and then every 6 months for up to 10 years after randomization to monitor their health and disease status. During the study, researchers assess relapse-free survival by documenting any return of cancer or death from 22 to 44 months after randomization. They also collect blood samples and perform imaging tests to monitor the disease and evaluate treatment effects. Safety is carefully monitored, and patients must have recovered from previous treatments before starting the study. The study includes long-term follow-up to observe survival outcomes and any differences based on genetic mutations or prior chemotherapy regimens.

Researchers are evaluating the effect of a multi-component chlorination intervention in healthcare facilities in western Kenya on the health of mothers and newborns. The study focuses on reducing bacterial contamination in water supplies, on staff hands, and on surfaces within maternity wards to lower the risk of infections, including antibiotic-resistant infections, among babies born in these facilities. The trial aims to measure the impact on gut carriage of harmful bacteria and symptoms of serious bacterial infections in newborns and their mothers during the first week after birth. The intervention includes installing passive chlorination devices for water treatment and providing a steady supply of chlorine disinfectant, either produced on-site by an electrochlorinator or delivered in bulk. Facilities also receive supplies for surface cleaning like mops, buckets, and spray bottles. All facilities, including control groups, receive infection prevention and control guidance and messaging. The trial enrolls 36 medium-sized public health facilities that meet specific criteria and runs over 24 months. Participants include pregnant adults and mature minors who come to these enrolled facilities to give birth, along with their newborns. Researchers will collect samples to check for bacterial contamination and antibiotic resistance, follow up for infection symptoms in the week after birth, and evaluate the effects of the intervention on maternal and neonatal health. The study monitors possible serious bacterial infections and maternal sepsis from birth to seven days after birth, aiming to generate evidence to improve infection prevention in low-resource healthcare settings.