Adverse Events

Failure to rescue refers to preventable deaths after surgery due to delays in identifying and treating complications. This research aims to evaluate whether a quality improvement intervention called '5 Rs to Rescue' can enhance monitoring and care for surgical patients in hospitals across four African countries: Ethiopia, South Africa, Tanzania, and Uganda. The study uses a multi-center, cluster trial design with mixed methods to assess the intervention's impact on reducing postoperative deaths. The '5 Rs to Rescue' intervention focuses on five key areas: assessing risk with the ASOS risk score, recognizing patient deterioration through regular vital signs and an Early Warning Score system, responding promptly using care pathways for common complications, reassessing patients after deterioration, and reflecting on care during regular meetings. This complex intervention is implemented in participating hospitals to improve patient surveillance after surgery. Participants are adults aged 18 and older who have surgery and receive postoperative care on study wards. Researchers will monitor the effectiveness of the intervention by reporting site-specific findings related to reducing in-hospital deaths within 72 hours after surgery. The study includes process evaluations and ongoing reflections to understand how the program works in practice. Participation involves routine monitoring and data collection during the postoperative period, with study completion expected by September 2026.

This research aims to understand how thumb-tack needle therapy affects sleep and recovery after surgery in patients who have undergone general anesthesia for breast cancer surgery. The study focuses on improving postoperative sleep quality, preventing sleep disorders, and promoting recovery following surgery. Participants are women aged 18 to 55 years with no history of chronic insomnia or recent use of sedative-hypnotic drugs. Participants in this observational study will undergo thumb-tack needle therapy as part of their postoperative care. The therapy's impact will be monitored without assigning different treatment groups. The study will follow patients before and after anesthesia exposure to observe changes in sleep quality and recovery. During the study, researchers will assess sleep quality using the Pittsburgh Sleep Quality Index (PSQI) one or two days before anesthesia and on days 1, 3, and 7 after anesthesia. Recovery will also be evaluated with the QoR-40 questionnaire on the third day after surgery. The study monitors patient progress to explore the clinical significance of thumb-tack needle therapy in improving postoperative outcomes.

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 phases—single and multiple ascending doses—and 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.

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.

Researchers are evaluating the efficacy and safety of biological agents in patients with allergic bronchopulmonary aspergillosis (ABPA), a condition that often affects people with severe bronchial asthma. The study follows guidelines from ISHAM for ABPA diagnosis and treatment, aiming to understand how biologics can impact this condition. This is a prospective, multicenter observational cohort study sponsored by Qianfoshan Hospital. Participants receive standard medical treatment consisting of oral prednisone with a tapering dose over several weeks, with or without oral voriconazole. Some patients also receive biological agents combined with this standard therapy for at least four months, following GINA2025 guidelines. The biologics are given alongside existing asthma treatments, such as inhaled corticosteroids and long-acting beta-agonists. The study compares groups receiving biologics plus standard treatment versus standard treatment alone. During the study, researchers monitor participants for one to two years, assessing the number of exacerbations, hospitalizations, time to first exacerbation, remission rates, glucocorticoid use, asthma control, and various immune markers such as serum IgE and eosinophil counts. Safety and overall mortality are also tracked. This extensive follow-up includes measuring treatment responses at eight weeks and ongoing assessments to evaluate long-term effects and disease control.

Researchers are developing and validating an artificial intelligence (AI) model to predict treatment-related complications in children with perimembranous ventricular septal defect (pmVSD) who have undergone transcatheter device closure. This observational study aims to determine if combining information from demographics, lab results, health records, echocardiography, chest X-rays, and electrocardiograms can accurately assess individual risk of complications within 30 days after the procedure. The study uses retrospective clinical data from pediatric patients treated at a single center. The AI model will be trained using deep learning techniques to analyze various types of clinical data, including text and images, collected from routine care records. The study does not involve any new treatments or interventions but focuses on data integration and AI prediction methods. The primary outcome is the occurrence of procedure-related complications within 30 days after the transcatheter closure. Participants are children aged 18 years or younger who had a confirmed diagnosis of pmVSD and underwent transcatheter device closure at the study center. Researchers will review medical records to gather necessary clinical and imaging data. The study evaluates the AI model's performance in predicting complications using metrics such as precision-recall curves, sensitivity, and predictive values, all within 30 days after the procedure. The study is sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, and is planned to end in June 2026.

This research aims to understand if using a drain after lumbar spine surgery can reduce recovery problems like infection or the need for further surgery. It focuses on patients undergoing one- or two-level open posterior lumbar decompression or decompression and fusion to treat lumbar stenosis and/or spondylolisthesis. The main goal is to compare the risk of returning to surgery within 90 days among different drainage methods. Participants will be randomly assigned to one of three groups: using a drain with compression suction, using a drain with gravity alone, or not using a drain at all. The drain is a small flexible tube placed next to the spine where the surgery occurred. The study will observe how these different drainage techniques affect recovery, including how long drains remain in place and any complications. During the study, researchers will monitor participants for up to 90 days after surgery. They will check for the need for reoperation, measure drain volume, track blood transfusions, length of hospital stay, and any complications. This thorough follow-up aims to provide detailed information on the safety and effects of different drainage methods after spinal surgery.

Researchers are studying whether fecal microbiota transplantation (FMT) can help treat gastrointestinal symptoms caused by chemotherapy or targeted therapy in patients with gastrointestinal cancers. This Phase 1 trial aims to evaluate the effect of FMT on the gastrointestinal tract in these patients, focusing on those with advanced gastrointestinal tumors. The goal is to understand how FMT might reduce side effects linked to cancer treatment. Participants are randomly assigned to one of two groups. The control group continues their usual chemotherapy or targeted therapy cycles every three weeks for five cycles, with treatment effectiveness assessed after every two cycles. The experimental group receives FMT starting from the fourth treatment cycle, with capsules containing donor gut bacteria given orally within three days before chemotherapy during the fourth, sixth, and eighth cycles. Each FMT dose includes about 40 grams of bacteria encapsulated into 120 capsules, taken over a short period during each treatment cycle. Throughout the study, patients undergo regular assessments to track gastrointestinal symptoms and gut microbiota changes. Researchers monitor the incidence and improvement of gastrointestinal side effects at 4 and 8 weeks after FMT. They also analyze gut microbiota diversity and its correlation with symptom improvement. Participants are followed during treatment cycles and for a post-treatment period to evaluate these outcomes, with safety and organ function closely observed.

Researchers are evaluating ways to improve well-being and child welfare outcomes among families at risk of substance misuse by engaging fathers in the Bronx and nearby communities. The study focuses on fathers who are custodial or non-custodial and aims to compare usual services with enhanced fatherhood engagement programs to support families facing substance use concerns. Participants will be randomly assigned to one of two groups: one receiving services as usual, and the other receiving enhanced services through a Regional Partnership Grant. Enhanced services include Motivational Enhancement to encourage substance abuse treatment engagement, participation in the HERO Dads fatherhood program to improve parenting skills, Contingency Management to support attendance and abstinence, and Case Management for referrals to treatment and resources. During the study, fathers and their families will be assessed at the start and after six months to measure child well-being and father engagement using various parenting and behavioral health scales. The study includes follow-ups to track changes in father involvement, mental health, and substance use, ensuring ongoing monitoring of outcomes over the study period.

Researchers are exploring the immune cell makeup of bronchoalveolar lavage (BAL) fluid from cancer patients who develop pneumonitis caused by cancer treatments such as immune checkpoint blockade (ICI), radiotherapy (RT), or tyrosine kinase inhibitors (TKI). This observational study aims to identify detailed immune cell profiles at the single-cell level, which may lead to new diagnostic biomarkers and treatment targets. Additionally, the study investigates whether single-cell analysis of blood samples can reveal non-invasive biomarkers for immune checkpoint blockade toxicity. The study uses advanced single-cell RNA and TCR sequencing techniques on up to 5,000 cells per sample from BAL fluid and peripheral blood mononuclear cells (PBMC). Researchers analyze gene expression and cell surface proteins to classify immune cells and their states, including T cells, NK cells, B cells, and myeloid cells. The study groups include cancer patients experiencing pneumonitis induced by immune checkpoint blockade, radiotherapy, or targeted therapy (TKI), all receiving standard-of-care treatments. Participants provide BAL fluid samples during bronchoscopy and blood samples for analysis. The study monitors immune cell proportions and gene expression changes in these samples over approximately two years from inclusion. Researchers use bioinformatics tools to characterize immune profiles linked to different types of treatment-induced pneumonitis. The study does not involve any investigational treatments but focuses on detailed immune profiling to improve understanding and diagnosis of therapy-related lung toxicity.