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 interventions 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 therapys 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 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.

Researchers are developing and validating a multimodal artificial intelligence AI model to predict treatment-related complications in children with perimembranous ventricular septal defect pmVSD who undergo transcatheter device closure. This observational study aims to determine if integrating data such as demographics, lab results, electronic health records, echocardiography reports, chest X-rays, and electrocardiograms can help accurately assess individual risk of complications within 30 days after the procedure. The study collects data retrospectively from routine clinical care records of pediatric patients who had the transcatheter closure for pmVSD. Deep learning techniques will be applied to extract features from text and imaging to train and validate the AI prediction model. No direct treatment or intervention is administered as part of this study. Participants involvement consists of the use of their existing medical records and clinical data. Researchers will analyze this information to measure procedure-related complications up to 30 days following closure, and evaluate the models accuracy through metrics like sensitivity, positive and negative predictive values, and precision-recall curves. The study is expected to be completed by the end of 2027.

This research aims to evaluate whether using a drain after one- or two-level open posterior lumbar decompression or decompression and fusion surgery for lumbar stenosis andor spondylolisthesis can reduce recovery problems such as infection or the need for additional surgery. The study focuses on comparing different drainage techniques to understand their impact on the risk of returning to the operating room within 90 days after surgery. Participants will be randomly assigned to one of three groups one using an active drain with compression suction, one using a passive drain relying on gravity, and one group receiving no drain. The drain is a small flexible tube placed next to the operated area of the spine. The study will track outcomes including the need for reoperation, time until drain removal, drain volume, blood transfusions, length of hospital stay, and complications for up to 90 days postoperatively. During the study, participants will undergo assessments related to their recovery and surgical outcomes over the 90-day follow-up period. Researchers will monitor the frequency and timing of any additional surgeries, complications, and hospital resource use. This monitoring aims to provide a detailed understanding of how drainage techniques may influence postoperative recovery after lumbar spine 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.