Safety

This research aims to evaluate a 5-session cognitive behavioral program called 1MoreStep, designed for Black women living with HIV who have experienced intimate partner violence in the past two years. The study focuses on teaching skills to access personal and external strengths, safety strategies, knowledge about HIV care and stigma, communication skills to handle stigma, and addressing barriers to HIV care. It also examines the programs acceptability and feasibility among participants. Participants are randomly assigned to either the 1MoreStep intervention or an equal attention control group. The intervention includes seven group sessions and one individual session held weekly, led by experienced facilitators from the Black community. Sessions cover topics such as safety planning, HIV care engagement, stigma communication, and goal setting using cognitive behavioral skills. The control group attends weekly support group sessions that cover general health topics important to Black women living with HIV but not directly related to the interventions goals. Throughout the study, participants complete assessments at baseline, 3 months, and 6 months to measure changes in safety strategies and HIV care engagement. Measures include surveys, medical record reviews, and interviews to evaluate treatment acceptance, session attendance, and participant experiences. The study spans approximately 6 months post-baseline, with follow-up surveys and qualitative interviews to explore program fit and barriers to participation.

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.

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 research aims to evaluate a gender-transformative intervention designed to reduce intimate partner violence IPV against infertile women. It focuses on couples diagnosed with female-factor infertility undergoing their first or second IVF or ICSI cycle. The trial addresses the overlap between infertility and IPV, recognizing that infertile women face higher risks of IPV and that their needs have often been overlooked. Participants are randomly assigned to one of two groups. The intervention group receives five 60-minute sessions led by trained nurses and social workers throughout the fertility treatment cycle. These sessions cover gender norms, gender equality, and healthy relationship skills at key treatment stages before the cycle starts, during follicular monitoring, before oocyte retrieval, two weeks after embryo transfer, and 28-30 days post-transfer. The control group receives standard reproductive care. A total of 376 couples will participate, split evenly between the two groups. During the study, couples will undergo assessments at baseline and multiple points up to about 14 months after delivery. Researchers will measure the rate of IPV against infertile women over the past 12 months as the primary outcome. Secondary assessments include IPV against male partners, attitudes toward gender roles, marital quality, coping with stress, patient satisfaction with treatment, pregnancy outcomes, and neonatal health. This comprehensive follow-up includes questionnaires, clinical pregnancy tests, and monitoring of birth outcomes to understand the interventions impact over time.

Falls and injuries from falls are a major health concern for older adults, leading to injuries, longer hospital stays, reduced mobility, and a lower quality of life. Researchers are evaluating the effectiveness of a technology-enhanced, multi-domain, multi-component falls prevention program called SAFE-TECH for community-dwelling older adults at higher risk of falling. This trial aims to improve on previous programs by using wearable technology to better identify those at high risk and tailor interventions to individual needs. Participants are randomly assigned to either the intervention or control group. Those in the intervention group receive a 12-week program combining progressive exercises targeting strength, balance, flexibility, coordination, and endurance with education addressing fall risk factors such as medication use, nutrition, pain, blood pressure drops, vision, and home hazards. After the active phase, participants enter a 9-month maintenance phase encouraging continued physical activity and fall prevention behavior. The control group receives usual care without intervention for 12 months. Participants will be assessed at the start, at 3 months, and again at 12 months on various factors including physical function, cognitive status, quality of life, and fall history. Monthly phone calls will track falls, healthcare use, physical activity, and confidence in exercising. The main outcome measured is the number of participants who experience falls over the year, along with injuries from falls and changes in physical function and behavior. The study lasts about one year for each participant.

Healthcare professionals often face severe stress, which can lead to sick leave and affect their well-being. This research aims to evaluate whether a five-week internet-based compassion course can help reduce stress of conscience and work-related stress, while improving professional quality of life and self-compassion. The study compares this compassion course with a general internet-based cognitive behavioral therapy CBT stress management course and a waitlist group. Participants will be randomly assigned to one of three groups a therapist-guided internet compassion course, a therapist-guided general internet CBT stress management course, or a waitlist for 10 weeks followed by the general CBT course. Both courses are structured self-help programs lasting five weeks, including weekly reports and therapist feedback delivered online. The compassion course focuses on compassion-focused therapy methods, while the CBT course uses traditional CBT techniques. Throughout the study, participants will complete assessments at baseline, 5, 10, and 15 weeks, and again at 6 months. These assessments measure changes in stress of conscience, professional quality of life, work-related stress, and self-compassion. Data are collected through self-assessment forms, and the study tracks progress over time to understand the effects of the courses. The total participation time spans up to 6 months to monitor longer-term outcomes and maintenance of benefits.

Researchers are evaluating the safety and tolerability of single and multiple increasing doses of GenSci098 given under the skin in patients with active thyroid eye disease TED related to Graves disease. This Phase 1 clinical trial aims to understand how the body processes this drug and to monitor for any side effects. The study is sponsored by Changchun GeneScience Pharmaceutical Co., Ltd. Participants will receive subcutaneous injections of GenSci098 at one of five dose levels 15mg, 45mg, 90mg, 180mg, or 270mg or a matching placebo. The study includes two parts a single ascending dose SAD phase where participants receive one dose, and a multiple ascending dose MAD phase where participants receive repeated doses. The study uses a randomized and quadruple-blind design to compare GenSci098 and placebo. During the study, participants will be monitored for adverse events through physical exams, vital signs, laboratory tests, and ECGs over periods of up to 169 days in the SAD part and 281 days in the MAD part. Researchers will also measure how GenSci098 moves through and acts in the body, including antibody responses. Participants will be asked to comply with study treatments and assessments until the study ends.

Researchers are evaluating GenSci098, a drug given as single ascending subcutaneous doses, in adults with Graves Disease to study its safety and tolerability. This phase 1 clinical trial aims to understand the effects of GenSci098 on patients with confirmed diffuse toxic goiter and abnormal thyroid function. The study is sponsored by Changchun GeneScience Pharmaceutical Co., Ltd. and focuses on monitoring adverse events and drug behavior in the body. Participants will receive only one dose of GenSci098 injected under the skin at one of several dose levels. The study includes a follow-up period lasting 141 days, during which safety and tolerability will be assessed. There is no placebo or control group, and the trial is not blinded. The focus is on careful monitoring after the single dose administration. Throughout the study, participants will undergo physical exams, vital sign checks, laboratory tests, and 12-lead electrocardiograms to detect any adverse effects. Researchers will track the incidence and severity of adverse events during the 141-day observation window. Participants must comply with the follow-up schedule and study requirements to ensure accurate safety monitoring and data collection.

Researchers are studying the safety and effects of an updated COVID-19 vaccine called BNT162b2 in healthy adults aged 18 to 64 years. This study compares the BNT162b2 vaccine to a Tdap vaccine, which protects against tetanus, diphtheria, and pertussis. Participants are medically stable adults without recent COVID-19 infection or vaccination and without conditions that increase their risk of severe COVID-19. Participants will be randomly assigned to receive a single injection of either the variant-adapted BNT162b2 vaccine or the Tdap vaccine on Day 1 of the study. Neither the participants nor the study team will know which injection is administered. The study uses a parallel design and lasts for about 12 months. During the study, participants will be monitored for local and systemic reactions within 7 days after vaccination, adverse events through 1 month, and serious adverse events for up to 12 months. Researchers will also measure SARS-CoV-2 spike protein levels up to 12 months post-vaccination. The study includes regular safety assessments and follow-up visits over the year-long participation period.