Adverse Drug Reaction

This research aims to evaluate whether taking antipsychotic medication every other day is as effective as the usual daily dosing for people with schizophrenia or related disorders. The study also explores if the alternate day dosing reduces side effects compared to daily treatment. It is a randomized, double-blind trial designed to compare these two dosing schedules over one year. Participants will be randomly assigned to either continue their current daily antipsychotic medication risperidone, olanzapine, or paliperidone or switch to an alternate day dosing schedule. To maintain blinding, active medication and placebo capsules are provided in matching blister packs so participants and staff cannot tell which regimen is assigned. Doses range from 1 mg to 16 mg for risperidone, 5 mg to 20 mg for olanzapine, and 3 mg to 12 mg for paliperidone. Treatment is individualized, and other psychotropic medications can continue if stable. Participants will attend 22 visits over 52 weeks, with visits every two weeks for the first six months and monthly visits for the final six months. Researchers will assess symptom severity and side effects using several scales, including the Brief Psychiatric Rating Scale and multiple symptom and wellbeing questionnaires. The main outcome focuses on clinical deterioration at the start and end of the study. Safety and medication adherence will be closely monitored throughout the trial.

Researchers are investigating acute myocardial inflammation, a complex condition that includes acute cellular cardiac allograft rejection ACR, cardiac sarcoidosis CS, and immune checkpoint inhibitor induced myocarditis ICIM. This study aims to evaluate the accuracy of 68GaGa-PentixaFor PETCT imaging for detecting inflammatory cells in these patients, offering a potentially non-invasive diagnostic option. The study is a phase 2 trial focusing on these specific heart inflammation conditions where diagnosis is currently challenging. Participants will receive an intravenous injection of a maximum of 50 micrograms of PentixaFor labeled with 150 15 MBq of Gallium-68 68Ga as a bolus 60 15 minutes before undergoing PETCT imaging. The treatment involves this imaging procedure for all three patient groups ACR, CS, ICIM to assess the presence and characteristics of myocardial inflammation. During the study, researchers will evaluate imaging results by analyzing lesion number, location, and standardized uptake value SUV over one year. They will also monitor toxicity data for safety assessment. Participants will have regular clinical follow-ups at the cardiology department. The study involves signing informed consent and includes monitoring for any adverse effects related to the imaging agent or procedures throughout the study duration.

Researchers are evaluating the safety and tolerability of GenSci134, a drug given by subcutaneous injection, in healthy adult volunteers and adults with Growth Hormone Deficiency AGHD. This study has two parts the first part involves healthy volunteers in two phasessingle and multiple ascending dosesand the second part includes AGHD patients receiving a single ascending dose. The trial aims to assess safety, how the drug acts in the body pharmacokinetics and pharmacodynamics, immune responses, and other exploratory effects. In the first part, Phase Ia tests single doses of GenSci134 in healthy adult males across seven dose groups with placebo and active controls. Phase Ib evaluates multiple doses in healthy adult males and females in three dose groups. The second part, Phase Ic, studies two dose groups of AGHD patients receiving single doses of GenSci134 compared to active controls. The active comparator is recombinant human growth hormone injection given daily for 28 days. Treatments are given subcutaneously, and the study is randomized and double-blind. Participants will undergo safety assessments including monitoring adverse events for up to three months after dosing. Researchers will collect data on drug absorption, effects on the body, immune response, and tolerability. Healthy volunteers and AGHD patients will be monitored through scheduled visits involving laboratory tests and evaluations to track any side effects and responses to the treatments. The total participation duration varies by study phase and dosing schedule.

Researchers are evaluating the safety and effectiveness of tumor infiltrating lymphocyte TIL therapy in adults with advanced solid tumors. This early-phase study involves patients who have either relapsed, metastasized, or have primary solid tumors and have failed standard treatments or have no standard options available. The study focuses on patients with measurable tumors and a life expectancy of more than three months. Participants receive an infusion of their own expanded TILs, ranging from 1 billion to 50 billion cells, administered intravenously over 30 to 120 minutes. Before the infusion, patients undergo a non-myeloablative lymphodepletion treatment with hydroxychloroquine a single 600 mg dose and cyclophosphamide. The therapy is given after tumor tissue or malignant fluid is collected for TIL expansion. Throughout the study, participants are closely monitored for adverse events over six months and assessed for tumor response, disease control, duration of response, progression-free survival, and overall survival for up to 36 months. Quality of life changes are also evaluated during this period. Participants must adhere to follow-up visits and assessments to track treatment effects and safety over time.

Bipolar disorder BD is a serious mental illness that tends to run in families and affects behavior, thinking, emotions, social interactions, and work. It has characteristics like high prevalence, frequent recurrence, and early onset. Early recognition and diagnosis are challenging but important for better outcomes. This research aims to create a large, high-quality group of BD high-risk individuals by enrolling 400 participants over four years and following them intensively for ten years using an electronic mental health platform. The study will collect various types of data including clinical, genetic, cognitive, neuroimaging, sleep, EEG, eye movement, speech, facial expression, and movement to understand how biological, clinical, and environmental factors interact in BD onset. The study is observational and includes three groups children aged 6 to 18 who have at least one parent with BD, children with atypical depression diagnosed by DSM-5 criteria, and healthy children matched by age and gender without psychiatric family history. Participants will be assessed yearly for four years, including brain scans and multiple follow-ups to track the development of mental illnesses, brain structure and function, cognitive function, sleep quality, quality of life, and genetic features. Participants will be involved in annual evaluations for four years, including clinical assessments and brain imaging. Researchers will monitor the differences in development among the three groups over time. The main outcomes focus on the prevalence of mental illness, brain development, and multi-modal feature changes. Secondary outcomes include cognitive function, sleep quality, quality of life, and genetic differences. This long-term follow-up aims to develop predictive models for BD onset and guide early, personalized interventions for those at high risk.

This prospective, multicenter, observational cohort study focuses on patients with allergic bronchopulmonary aspergillosis. The aim is to evaluate the efficacy and safety of biological agents used in these patients across multiple participating centers. The study observes how biological agents perform in the treatment of allergic bronchopulmonary aspergillosis while also assessing their safety.

This clinical trial is investigating sedation methods during colonoscopic polypectomy procedures. It aims to compare the effects of remimazolam besylate combined with sufentanyl versus propofol combined with sufentanyl on circulatory and respiratory stability. The study also evaluates the incidence of hypotension and respiratory depression, as well as the overall sedation success and recovery times in adult patients. Participants are randomly assigned to one of two groups a study group receiving remimazolam besylate and sufentanyl, and a control group receiving propofol and sufentanyl. In both groups, patients receive intravenous sufentanyl followed by the sedative drug, with doses tailored to achieve the desired sedation level assessed by BIS monitoring and the Modified Observers Assessment of Alertness and Sedation Scale MOAAS. Continuous oxygen flow and non-invasive monitoring are applied during the procedure. Throughout the study, patients are monitored for vital signs including oxygen saturation, heart rate, blood pressure, and respiratory rate before, during, and after the procedure. Sedation depth, time to adequate sedation, full alertness, and recovery readiness are measured. Researchers also track drug doses, procedure duration, infusion volumes, and post-procedure symptoms such as pain, nausea, and vomiting. The total observation period per participant spans approximately 2 to 4 hours.

Researchers are studying the long-term risk of liver failure linked to TURALIO14 pexidartinib treatment in patients with symptomatic tenosynovial giant cell tumor TGCT who have severe symptoms or functional problems and cannot improve with surgery. This study also explores how liver damage happens by examining liver biopsy samples from patients who have or had liver toxicity while on TURALIO14. The goal is to understand liver injury mechanisms and assess safety over time. This is a non-interventional, observational study where no study medication is given. Participants have experienced liver test abnormalities from TURALIO14 treatment. Optional liver biopsies will be taken for detailed analysis of immune cells in the liver. Blood samples will also be collected to monitor liver function, safety, immune cells, and genetics. Participants will be followed yearly for up to 10 years to track liver health and potential failure after stopping TURALIO14. During the study, participants will provide blood samples and may choose to have a liver biopsy for further testing. Researchers will assess liver test results and monitor for signs of liver failure, liver transplant need, or death. Follow-up visits occur at least once per year for 10 years to observe long-term effects. The main outcome measured is how often liver failure occurs after stopping TURALIO14, helping to better understand long-term safety in this group.

Researchers are evaluating whether giving the antibiotic meropenem in shorter but more frequent infusions can achieve similar blood levels compared to longer, less frequent infusions in intensive care unit ICU patients. The study aims to see if administering 1 gram six times daily in 15-minute infusions matches the serum concentration of the usual 2 grams three times daily in three-hour infusions. This pilot study focuses on optimizing antibiotic dosing to improve intravenous access time in critically ill patients. Participants will be randomly assigned to one of two groups one receiving meropenem 1 gram six times daily through 15-minute infusions, and the other receiving 2 grams three times daily through three-hour infusions. The dosing will be adjusted based on daily kidney function monitoring. Blood samples will be collected at 24, 48, and 72 hours to measure antibiotic levels, and patients will be observed for side effects during treatment and for two days after. During the study, researchers will monitor serum meropenem concentrations to see if they stay above the minimum inhibitory concentration MIC for at least 50% of the time. Additional outcomes include days in the hospital, 30-day mortality after ICU admission, and serious side effects. The study involves daily blood tests and kidney function assessments, with the total study period running from 2021 to mid-2024. Patient safety and treatment adherence will be closely supervised throughout the trial.

This research aims to evaluate whether monitoring insulin levels and treating high insulin and blood sugar levels with the drug pioglitazone is feasible and safe in female patients receiving Alpelisib for metastatic breast cancer. The study focuses on women aged 18 to 85 with ER positive HER2 negative metastatic breast cancer who have a PIK3CA mutation. It also assesses how well this approach controls blood sugar, how often treatment doses are reduced or stopped, and how long patients live without cancer progression. Participants receive treatment with pioglitazone alongside Alpelisib and fulvestrant for their metastatic breast cancer. The study is an early phase 1 trial that follows patients as they receive this combined treatment, focusing on managing hyperinsulinemia and hyperglycemia induced by Alpelisib. The trial tracks treatment safety and feasibility while monitoring patient responses over an average of one year. Throughout the study, patients are regularly monitored for severe and all-grade hyperglycemia, insulin and glucose levels, and treatment side effects. Researchers also measure the progression-free survival of participants. Safety is carefully observed, including any dose adjustments or treatment discontinuations due to blood sugar issues. This monitoring helps evaluate the studys main outcomes and supports patient care during the trial period, which lasts about one year on average.