Tolerance

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.

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 investigating the role of acupuncture in managing pain and improving outcomes after total knee replacement surgery (TKA) for patients with primary osteoarthritis. This study aims to assess whether acupuncture can help control acute pain, prevent chronic pain, improve joint function, and increase patient satisfaction. The research also examines how acupuncture influences inflammation by measuring specific biomarkers, which may relate to recovery and long-term joint stiffness. Participants will receive standard anesthesiology care including sedation, regional nerve blocks, and pain medications. They will be randomly assigned to either a standard treatment group or an acupuncture group, which receives additional acupuncture and auriculotherapy sessions before and after surgery. The acupuncture treatment targets specific body and ear points over multiple sessions during the first three days post-surgery. Throughout the study, participants will be monitored regularly for pain levels, medication use, vital signs, joint mobility, and rehabilitation progress. Blood samples will be taken before surgery and at set intervals afterward to measure inflammation markers. Patient-reported outcomes and satisfaction will be collected up to one year post-surgery. Evaluations will be done in person or by phone if necessary, with the entire follow-up extending through one year after the operation.

Pain is described as an unpleasant sensory and emotional experience linked to actual or potential tissue damage. This research evaluates whether a single session of Low-Level Laser Therapy (LLLT), a safe and noninvasive treatment with pain-relief and anti-inflammatory effects, can produce immediate changes in pain threshold and pain tolerance in healthy adults. This study focuses on acute nociceptive pain, common in musculoskeletal conditions, and aims to understand LLLT's immediate impact compared to a sham treatment. Participants will be randomly assigned to receive either active LLLT or a sham laser procedure. The active treatment uses a 904 nm wavelength laser applied to three points near the medial epicondyle for a total of 6 minutes, delivering a set energy dose. The sham group undergoes the same procedure without actual laser emission to control for placebo effects. Both groups and the researcher wear safety eyewear during the process. During the study, researchers will measure electrical pain threshold and pain tolerance before and immediately after the intervention. Participants are healthy adults aged 18 to 35 without chronic medical conditions or pain. The trial includes monitoring for safety and adherence to protocols. The total participation involves a single session assessing immediate effects, with no long-term follow-up described.

Researchers are investigating how acute preoperative pain affects the development of chronic postsurgical pain (CPSP) in patients undergoing emergency orthopaedic or abdominal surgery. Unlike scheduled surgeries where preoperative pain lasts weeks or months, emergency surgery involves intense but short-term pain. This study aims to clarify the long-term impact of this acute pain on CPSP occurrence three months after surgery. Participants will be asked to complete a questionnaire 48 to 72 hours after surgery to share their pain experience and preoperative anxiety. Then, three months post-surgery, researchers will conduct a phone interview using a standardized questionnaire to assess the presence of chronic postsurgical pain. This approach allows evaluation of pain progression from acute to chronic phases following emergency surgery. During the study, patients' pain perception and anxiety levels shortly after surgery will be recorded, followed by a longer-term follow-up assessing the frequency of CPSP. The main measure is the occurrence of CPSP at three months. Participation involves questionnaires and phone interviews without additional treatments. The study is sponsored by Centre Hospitalier Universitaire, Amiens and is open to adults aged 18 and older undergoing emergency surgery.

Researchers are studying nasal mucosal immunity to respiratory viruses like SARS-CoV-2 in both immunocompromised adults and healthy volunteers aged 18 to 90. The study aims to understand how immune cell makeup and virus-specific responses differ between those with weakened immune systems due to medical conditions or treatments and those without such issues. This observational study compares these two groups to learn how immunodeficiency and related therapies affect immune responses. Participants are divided into two groups: immunocompromised patients with conditions like organ or stem cell transplants, ongoing immunosuppressive therapies, or genetic immunosuppression, and healthy volunteers with no underlying medical conditions or history of immune problems. There are no interventional treatments; instead, researchers collect data during routine clinical visits over approximately six months. During the study, participants undergo assessments at four periodic intervals roughly 45 days apart, starting from enrollment. These include measuring cytokines produced by nasal and blood T cells specific to viruses, as well as characterizing immune cells at enrollment. The study tracks immune responses over time to better understand how immunity persists or changes. Participants' safety and informed consent are ensured throughout the observation period, which lasts about six months from the first visit.

This research aims to evaluate the safety and effectiveness of Blinatumomab in children aged 2 to 17 years who have a difficult-to-treat form of steroid-resistant nephrotic syndrome (SRNS). These children either do not respond to calcineurin inhibitors (CNIs) or are resistant to multiple immunosuppressive treatments, including biologics. SRNS is characterized by heavy protein loss in urine and is linked to poor outcomes with limited treatment options. Participants will receive two short courses of low-dose Blinatumomab administered intravenously. Each course lasts 5 days, with the second course starting three weeks after the first. This open-label, single-arm study will enroll six children to assess whether this treatment can reduce proteinuria and induce remission by targeting specific immune cells. Throughout the study, researchers will monitor protein levels in urine, kidney function, safety, and immune markers over 24 to 52 weeks. Participants will undergo clinical assessments and laboratory tests to evaluate treatment effects and side effects. The study aims to gather preliminary data on Blinatumomab as a potential new therapy for children with resistant SRNS.

Researchers are evaluating the effectiveness of a contemplative practice called Feeding Your Demons (FYD), based on a secular adaptation of Tibetan Buddhism, in improving psychological well-being, body image, body acceptance, compassion, and self-deconstruction in adult women aged 30 to 60. This randomized controlled trial compares FYD with an active control group practicing mindfulness meditation, aiming to understand how these practices impact mental and emotional health. The study includes 122 women fluent in Spanish, with prior meditation experience. Participants will be randomly assigned to either the FYD or mindfulness meditation group. Both interventions are delivered online over eight weeks, involving weekly home practice sessions guided by audio. Each group receives three expert-led sessions: an initial individual meeting, a group session at week 4, and a final group session at week 8. The FYD practice involves a structured process of identifying internal challenges and transforming them through acceptance and compassion, while the mindfulness group focuses on breath awareness and non-judgmental observation. Participants will complete assessments before and after the intervention, and again at a six-month follow-up. These include psychological measures such as the Delusion of Me Index, Body Appreciation Scale, and various questionnaires on mindfulness, self-compassion, and body acceptance. A subgroup will also take part in qualitative interviews. Researchers will analyze changes over time and relationships between variables to understand the effects of both practices on well-being, compassion, and self-perception.