Acceptance

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.

Young adults aged 25 to 39 who have cancer face unique challenges in coping, and their partners who provide care may feel burdened and less confident in their caregiving roles. Researchers are evaluating a brief psychotherapy intervention designed to improve how these young adults and their caregiving partners cope with cancer and maintain their relationships. This pilot study aims to test whether this intervention is feasible and acceptable in this specific group, providing important information for future larger studies. The intervention involves eight weekly virtual psychotherapy sessions lasting 45 to 60 minutes, delivered to young adults with cancer and their self-identified partners together. It is based on cognitive-behavioral therapy and couples-focused therapy principles tailored for young adults. A trained mental health practitioner will guide the sessions, which include teaching, practical exercises, and home practice. The study includes 10 young adults with cancer and their caregiving partners, totaling 20 participants. Participants will complete surveys before starting the intervention and again after finishing the eight sessions to measure feasibility and acceptability over approximately 14 weeks. They will also be invited to take part in optional interviews to share their experiences. This study is sponsored by Massachusetts General Hospital and does not include a control group or blinding. The total duration of involvement for participants is about three and a half months.

This research aims to explore the effects and feasibility of a group-based Acceptance and Commitment Therapy (ACT) program for families of individuals with special health care needs. Parenting children with special needs can be stressful and impact caregivers' mental health, while individuals with special needs may struggle with the mismatch between their requirements and typical practices around them. The study focuses on promoting psychological flexibility, which supports value-guided living despite distressing thoughts or feelings. Participants will receive Acceptance and Commitment Therapy, a well-established behavioral psychotherapy adapted for families of individuals with special health care needs. The intervention is delivered in a group format tailored to these families. This pilot study evaluates how this therapy influences psychological flexibility and wellbeing over a six-week treatment period. During the study, participants will be assessed at baseline and at two, four, and six weeks into treatment. Researchers will measure changes in psychological flexibility, psychological inflexibility, psychological wellbeing, and parenting stress using standardized inventories and scales. Child behavior and participants' satisfaction and personal experiences with the program will also be evaluated. The study includes follow-up assessments within six weeks after completing treatment to understand the intervention's impact.

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.

This research investigates patient preference and the safety and eye-related effectiveness of a new treatment method called Dextenza combined with an intracameral antibiotic and NSAID, compared to standard eye drop therapy after cataract surgery. The study involves patients undergoing surgery in both eyes and aims to control pain and inflammation following the procedures. Participants will be randomly assigned to receive either the experimental treatment or the standard topical therapy in their first eye surgery. The experimental group receives a Dextenza dexamethasone intracanalicular insert placed in the lower punctum during surgery, along with intracameral ketorolac and moxifloxacin administered during and after the procedure. The control group receives standard topical drops including moxifloxacin, ketorolac, and prednisolone acetate at scheduled intervals before and after surgery. Two weeks later, the second eye will be operated on and treated with the alternate treatment. During the study, participants will attend several visits for assessments including patient preference measured 28 days after the second eye surgery, ocular inflammation scores, post-operative pain ratings, visual acuity tests, physician evaluations of insertion, and monitoring for adverse events. These evaluations occur at various time points up to two months following the second surgery, enabling researchers to compare the treatments comprehensively and monitor safety and effectiveness over time.

Researchers are evaluating the acceptability of soy milk as a calcium-rich beverage among school children in New York City Public Schools. This observational study aims to understand whether students choose and drink soy milk when offered alongside dairy milk, and to assess its impact on milk waste, nutrition, environmental factors, and costs. The study is sponsored by the Physicians Committee for Responsible Medicine and involves a pilot program in 11 schools covering grades K-12, ages 5 to 18. The intervention involves offering soy milk during school lunch for a four-week period in spring and fall 2026. Before the intervention, baseline measurements of cow's milk sales and consumption will be collected. During the intervention, taste tests will be conducted at each school, and students will be offered stickers for tasting soy milk. Marketing materials like posters and flyers will be used to promote the program. School staff and administrators will receive training to ensure safety, especially for students with allergies. Participants will be observed for milk consumption and sales throughout the pilot. Data collected includes the amount of soy milk and cow's milk consumed and sold. Allergy precautions are managed through school nurses and cafeteria managers to avoid including students with soy allergies. The primary outcome is the acceptability of soy milk over four weeks, with additional measures of milk consumption and food waste. The study runs through 2027, and no identifiable information will be collected from students.

Researchers are evaluating an Acceptance and Commitment Therapy (ACT)-based intervention aimed at reducing psychological symptoms and increasing psychological flexibility among parents of children with medical complexity. These parents often face ongoing stress from managing their child's chronic, complex health conditions and uncertainty about the prognosis. This pilot randomized controlled trial addresses a gap in studies on ACT for Chinese parents in local communities to help them better manage caregiving-related stress and emotions. The study involves two groups: one group receives the ACT-based intervention consisting of four weekly face-to-face sessions, each lasting two hours and including a question-and-answer period. The sessions cover topics such as understanding ACT, stress and struggles, role play, mindfulness exercises, and applying personal values to actions. The other group has the option to join usual community social or health care services available to parents of children with medical complexity. Participants will be assessed at the start and after four weeks using the Chinese versions of the Depression Anxiety Stress Scale and a psychological flexibility measure. The study will monitor changes in psychological symptoms and flexibility. Parents will participate in scheduled sessions and complete questionnaires, with the trial lasting four weeks of intervention plus assessments. The research team will observe feasibility and preliminary effects of the ACT intervention to inform future studies.

Researchers are evaluating the effectiveness of a self-help version of Acceptance and Commitment Therapy (ACT) called the ACT with CF Self-Help Toolkit for adults living with cystic fibrosis. This therapy aims to reduce anxiety and depression and improve psychological flexibility and value-based living in adults with CF, who are at higher risk for these mental health challenges. The study randomly assigns participants to one of two groups: one receives immediate access to the ACT with CF Self-Help Toolkit, which includes six main modules with short videos designed to help manage difficult feelings and encourage positive behaviors; the other group waits six weeks before receiving access to the toolkit. The treatment is delivered digitally and accessed on participants' smartphones. Participants complete a series of questionnaires at baseline, after six weeks, and again at three months to assess anxiety, depression, psychological flexibility, cognitive fusion, and values-based living. Additional data on medication adherence and lung function will be collected from health records. The study uses repeated measures and statistical models to analyze changes over time, with participant data securely sent for analysis. The total participation involves completing digital assessments and using the self-help toolkit over several months.