Meningitis

Researchers are studying the development of neural flexibility, measured by MRI, as an indicator of cognitive flexibility in Chinese toddlers aged 32 to 42 months. The study also evaluates executive functions such as inhibition, shifting attention, emotional control, working memory, and planning using the Global Executive Composite score from a standardized rating scale. This research aims to better understand brain development and cognitive abilities during early childhood. Participants are divided into two groups based on their daily milk consumption: one group receives S-26 GOLD or ULTIMA GUM formula, while the other consumes cow's milk. Parents continue feeding their children these milk products throughout the study, and information about milk consumption is collected starting up to two months before and during the study period. The brain is examined using MRI, a safe and non-invasive imaging technology. During the study, toddlers undergo MRI scans and assessments of brain structure and function at the start and again at 42 months of age. Researchers also evaluate cognitive flexibility, behavior, curiosity, sleep quality, home environment, feeding practices, and fecal microbiota composition over time. Parents provide information through interviews, and the child's development and school readiness are monitored. The study runs from baseline through 42 months of age, with additional home environment data collected at 8 months after baseline.

Researchers are evaluating the CIPHER System in patients undergoing brain tumor removal surgery for newly diagnosed supratentorial glioma. This First-in-Human clinical investigation aims to assess the safety and basic performance of a novel, highly flexible, electrode-dense cortical probe designed for neurophysiological mapping and stimulation during brain tumor resection. The study focuses on how well the device functions and its handling characteristics during short-term use in surgery. Participants will have the CIPHER Probe placed on the surface of the brain during standard tumor removal surgery. Two groups are studied: one where only neural activity is recorded and another where both recording and electrical stimulation are performed using the probe. No stimulation is delivered in the recording-only group. The device is tested on the main tumor area and the surrounding tissue margin just before tumor removal. During the study, participants will be monitored through hospital visits during their recovery period, including follow-ups at two and six weeks after surgery. Researchers will collect data on any device or procedure-related adverse events, spontaneous neural activity, signal quality, and device deficiencies. The total study period includes enrollment through the six-week postoperative follow-up to evaluate safety and device performance.

Gliomas are aggressive tumors that originate from glial or stem cells, with patients typically surviving between 12 to 15 months. This research investigates whether a classic ketogenic diet (CKD), which restricts carbohydrate intake and increases fat consumption to induce ketosis, can help extend survival in patients with high-grade gliomas and brain metastases. The study compares outcomes to historical controls to evaluate the diet's potential therapeutic effect. Participants will follow the CKD for an initial period of 3 months, which is a high-fat, low-carbohydrate diet adjusted to each patient's energy needs by dietitians. This diet aims to reduce blood glucose levels and increase ketone bodies to stimulate biochemical changes. Patients and their families will receive training on meal planning and ketone/glucose monitoring, and dietitians will provide ongoing support and follow-up visits. Throughout the study, participants will regularly monitor their urine and blood ketone levels daily and maintain records. Researchers will assess overall survival up to 36 months, tumor size changes, time to progression, quality of life, and functional impairment using established scales and surveys. Follow-up evaluations will occur at baseline and various intervals up to 24 months. The study includes safety assessments and continues monitoring until death or the study endpoint.

Researchers are evaluating the safety, tolerability, and how the body processes (pharmacokinetics) single and multiple intravenous doses of a drug called BWC0977 in healthy adult volunteers. This Phase 1 study involves a total of 64 healthy adults aged 18 to 55 years and is designed as a randomized, double-blind, placebo-controlled trial with multiple dose groups. The study focuses on measuring any treatment-emergent adverse events and serious adverse events to understand the drug's safety profile. Participants will be divided into two main groups: single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. In the SAD phase, volunteers receive one intravenous infusion of BWC0977 or placebo over 2 hours at doses of 750 mg or 1500 mg. In the MAD phase, participants receive multiple intravenous infusions of BWC0977 or placebo over 30 minutes to 2 hours daily for 7 to 10 consecutive days. Dose levels will increase sequentially based on safety and tolerability data collected during the study. During the study, participants will undergo various assessments including physical exams, vital signs, ECGs, laboratory tests, and blood sampling at specific times before, during, and after infusions to monitor safety and measure drug levels in the body. Researchers will track adverse events for up to 8 days after single dosing and up to 16 days after multiple dosing. Volunteers must comply with study visits and requirements throughout the trial, which lasts until August 2026.

Researchers are investigating whether adding a rapid biomarker test to current clinical guidelines can better identify young children with fever who are at risk of serious infections in sub-Saharan Africa. This study compares standard care based on integrated management of childhood illness (IMCI) guidelines alone to an approach enhanced by measuring suPAR levels, a biomarker, during the first clinical assessment. The goal is to see if this combined strategy improves decisions about hospital admission or discharge and leads to better health outcomes for children aged 2 to under 60 months. The trial is a multi-country, open-label, randomized study with two groups: one receiving the standard IMCI-based care and the other receiving IMCI care plus a point-of-care suPAR test. Blood samples will be taken from all children, but only the intervention group will have their suPAR levels measured immediately. Clinicians will use these results along with IMCI guidelines to decide whether to admit or discharge each child during the first clinical visit. A second, more detailed clinical assessment will also be performed on all participants to confirm or adjust decisions and ensure safety. Children will be followed up on days 3 and 7 after enrollment with additional visits if clinical worsening occurs. A day 28 follow-up will collect information on serious events, hospitalizations, or deaths, with an optional extra interview at three months. Participants with respiratory symptoms may join a substudy involving lung exams and sample collections. The study team will measure outcomes like the appropriateness of discharge decisions, hospital admissions, severity of illness, and mortality to evaluate the new triage approach's effectiveness and safety over these timeframes.

Researchers are conducting a prospective, multicenter observational clinical registry involving adult patients aged 18 and older with suspected acute infectious meningitis, across about 30 public and private hospitals in Brazil. The study aims to gather real-world evidence on current clinical management, treatments, and both short- and long-term outcomes to support improvements in national care protocols. It focuses on meningitis caused by viral, bacterial, or fungal infections. Clinical and laboratory data will be collected during hospitalization and through follow-up visits after discharge. The data include timing and type of empirical antibiotic therapy, time from hospital admission to first antibiotic dose, corticosteroid therapy initiation, vaccination status according to the Brazilian National Immunization Program, neurological complications, and access to specialized rehabilitation services post-discharge. The study will assess outcomes such as mortality, hospital stay length, re-hospitalization rates, and sensorineural hearing loss. Participants will be monitored closely during hospitalization and after discharge, with data collection aimed at evaluating functional status through measures like the modified Rankin Score and Barthel Index. Researchers will track serious adverse events, neurological sequelae, and rehabilitation access over a period extending up to 180 days. This comprehensive follow-up will help inform public health and clinical care improvements in Brazil.

Researchers are evaluating the safety and effectiveness of a new device called the IRRAflow Active Fluid Exchange System compared to the standard External Ventricular Drain (EVD) in patients with brain bleeding and infections. This study focuses on conditions such as intraventricular hemorrhage, subarachnoid hemorrhage, subdural hematoma, and ventriculitis. The goal is to see if the IRRAflow device can better remove cerebrospinal fluid, blood, and harmful bacteria from specific brain spaces. Participants will be randomly assigned to receive either the IRRAflow device or the EVD device. Both devices are used to monitor and reduce intracranial pressure by draining excess fluid from the brain. The IRRAflow system includes an irrigation feature to help keep the drainage catheter clear by using programmed pulses of fluid, while the EVD device represents the current standard care method. After the procedure, participants will be followed for one month to compare outcomes between the two groups. During the study, participants will undergo various assessments including head CT scans to measure clearance of blood or bacterial mass, monitoring for catheter-related infections, tracking the length of stay in intensive care, and evaluating functional status at the start and 30 days after discharge. Researchers will also monitor rates of revision procedures, shunt dependency, and mortality during and after treatment. The study aims to provide detailed information about how these devices perform in managing intracranial bleeding and infections over a one-month period.

Researchers are conducting an international observational study to better understand acute infections in adults who are hospitalized. This study focuses on collecting data and biospecimens to characterize various infectious diseases, including respiratory infections, infections outside the respiratory tract, established infectious diseases, and newly emerging infections. The aim is to gather information that will help identify risk factors, clinical features, and management strategies, as well as to aid in designing future clinical trials. Participants include adults admitted to the hospital with suspected or confirmed acute infections. There is no intervention or treatment being tested, as this is an observational study. The research involves monitoring patients during their hospital stay to collect vital data and samples related to their infection. Participants will be observed over time, with researchers assessing outcomes such as mortality by day 28, time to recovery, clinical improvement by day 7, organ support-free days, and organ failure scores. Data collection includes clinical assessments and biospecimen sampling to better understand infection progression and patient recovery. The study begins in August 2025 and continues through June 2027, allowing for extensive data gathering and analysis.

Researchers are studying cerebrospinal fluid leakage after supratentorial craniotomy, a surgery performed on the upper part of the brain to remove intracranial tumors. This leakage can occur when the protective covering of the brain, called the dura, does not close properly after surgery. Leakage can lead to wound healing problems, infections, longer hospital stays, and delays in additional treatments like radiotherapy or chemotherapy. Although less common in supratentorial surgeries than others, cerebrospinal fluid leakage remains a challenging complication that has not been well studied in this patient group. This observational study will follow patients undergoing supratentorial craniotomy to remove brain tumors. The study will track how often cerebrospinal fluid leaks occur, identify patient and surgical factors that increase risk, and observe how these leaks are treated. Data collection will include tumor characteristics, types of dural closure, materials used, and treatment approaches. The study will observe patients for six weeks after surgery, which aligns with the usual start of additional cancer treatments. Participants will be monitored for fluid leakage signs, infections at the surgical site, and any need for extra medical visits or hospital stays related to leakage. Researchers will evaluate the timing of leaks and details of surgical techniques used. The goal is to better understand leakage incidence, risk factors, and management to improve recovery after brain tumor surgery.

Researchers are developing and managing the AnovaOS Network Powered Patient Registry to collect real-world patient data across various diseases globally. This registry aims to capture meaningful clinical information on diagnosis, infection course, treatments, and outcomes to enhance understanding and support future clinical trials and observational studies. The registry serves as a resource to better understand, prevent, diagnose, and treat diverse health conditions. Participants' data will be gathered through this registry, which can also be used to recruit individuals for clinical trials and observational studies on promising therapies. The registry collects ongoing information on patients' health status and treatments, enabling long-term monitoring and analysis. This observational study does not involve administering treatments but focuses on data collection and management. Participants will provide information through questionnaires or instruments, either personally or via an informed proxy, with an expected follow-up once per year. The research team will assess natural history, clinical effectiveness, safety, and quality of care over a period of five years. The registry includes patients with a wide range of conditions, and participation requires informed consent and the ability to complete follow-up data collection.