Hyperthyroidism

This research aims to study children with hyperthyroidism by collecting information on their diagnosis, treatment, and long-term follow-up. The study focuses on understanding the clinical features, treatment effects, side effects, remission, and relapse of hyperthyroidism in children. It also investigates factors that predict the response to antithyroid drug treatment and explores risks linked to adverse reactions from these drugs. The study observes children treated with methimazole (MMI), a drug given initially at 0.2-0.8 mg per kilogram per day. The dose is gradually reduced and adjusted based on thyroid hormone test results to maintain normal thyroid function. This observational study includes both retrospective and prospective data collection without any intervention. Participants will be monitored over time to assess remission, defined as normal thyroid function without methimazole for at least 12 months, and adverse effects such as neutropenia, liver dysfunction, rash, and muscle or joint pain. Relapse after stopping methimazole will also be tracked. The study involves clinical evaluations, biochemical tests, and long-term follow-up lasting up to 10 years to understand treatment outcomes and safety.

Researchers are evaluating microwave ablation (MWA) as a minimally invasive treatment option for patients with relapsed Graves' disease who have previously been treated with anti-thyroid drugs but experienced a return of symptoms. Graves' disease is the most common cause of hyperthyroidism, and conventional treatments include anti-thyroid drugs, radioiodine, and surgery. However, these treatments have drawbacks such as side effects, risk of worsening eye symptoms, or surgical complications, which has led to interest in alternative therapies like MWA. In this study, all participants will receive ultrasound-guided MWA treatment using a device that inserts a microwave antenna into the thyroid gland to apply thermal energy and ablate the tissue. The procedure targets the entire thyroid gland, including both lobes, the isthmus, and the pyramidal lobe. This approach avoids surgical scars and preserves the organ, and it is performed as an outpatient procedure. The study does not involve comparison groups but focuses on evaluating this treatment. During the study, participants will be monitored for remission of Graves' disease six months after the procedure. Researchers will also measure changes in quality of life and thyroid gland volume at six months. The study includes follow-up assessments to evaluate treatment outcomes and safety. Participants can expect clinical evaluations and ultrasound examinations as part of their involvement. The total participation duration extends at least six months post-treatment.

Researchers are studying the use of a diagnostic device called ISAR-M THYRO to detect bleeding early after thyroid surgery. Postoperative bleeding occurs in 0.6 to 4% of patients, with most cases happening within the first 48 hours and potentially leading to serious complications or death. The study aims to improve early detection by continuously measuring neck pressure, which may indicate bleeding earlier than current symptom-based methods. Participants will have the ISAR-M THYRO device applied after thyroid surgery to continuously measure and digitally document neck pressure for up to 48 hours. The device includes alarms and a display that can be turned off. This observational study focuses on collecting data to assess the device's ability to detect bleeding early through pressure monitoring during the critical postoperative period. During the study, participants will be monitored for neck pressure changes using the device, and researchers will evaluate the sensitivity and specificity of bleeding detection within 48 hours after surgery. Safety of the device will be assessed for one month. The study helps understand if continuous pressure monitoring can provide timely alerts to reduce serious complications after thyroid surgery.

This research aims to evaluate the effects of thyroid hormone supplementation in patients undergoing hemodialysis who have elevated thyrotropin (TSH) levels, a common complication in chronic kidney disease. Previous studies have shown that higher TSH levels are linked to poorer quality of life and increased cardiovascular risks in these patients. The trial seeks to clarify whether levothyroxine treatment can improve patient-centered outcomes and cardiovascular health, as well as its metabolic effects in this population. Participants will be randomly assigned to receive either levothyroxine or a matching placebo for 24 weeks. Initial doses depend on their TSH levels, with adjustments after 8 and 16 weeks based on follow-up TSH measurements, aiming to maintain TSH within a target range. Both groups undergo similar pill titration schedules to maintain study balance. The trial is double-blind and placebo-controlled to ensure unbiased results. During the study, participants will have assessments of quality of life, coronary artery calcification, physical performance, endothelial function, vascular markers, body fat, muscle strength, heart function, and energy expenditure at baseline and after 24 weeks. These evaluations help researchers determine the impact of levothyroxine on health-related quality of life and cardiovascular parameters. The total study participation spans approximately six months with regular monitoring.

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 evaluating how well multiparametric ultrasound (mpUS) imaging can examine and provide information about cancerous and non-cancerous tissues. This study compares mpUS, which combines different ultrasound methods to show detailed tissue structure and blood flow, with standard ultrasound and other tests. The goal is to see if mpUS can offer a more accurate assessment, especially for pancreatic cancer and thyroid nodules. Participants will receive additional mpUS imaging during their standard ultrasound procedures, which adds about 5 to 15 minutes of scan time. There are three groups: patients at high risk for pancreatic cancer undergoing endoscopic ultrasound, patients with pancreatic ductal adenocarcinoma receiving endoscopic ultrasound-guided biopsies, and patients having thyroid nodule biopsies. Healthy volunteers without cancer or thyroid nodules may also join. During the study, participants will undergo mpUS imaging alongside their usual care scans. Researchers will collect the extra ultrasound data to evaluate the feasibility of mpUS imaging. The main outcome is assessing how well mpUS works during the imaging procedures. This study is non-randomized, has no masking, and will continue until November 2027. Participants may be followed up as agreed, and the total added scan time is brief.

Researchers are evaluating the use of online outpatient follow-up compared to traditional offline follow-up for patients who have undergone surgery for papillary thyroid cancer. This randomized controlled trial aims to assess the adherence to outpatient procedures over a 12-month period. The study includes adults between 18 and 90 years old who have had thyroid surgery and are able to communicate in Chinese and use the internet for visits. Participants are randomly assigned to one of two groups: one group uses the Huayitong app for their post-operative follow-up, while the other group attends standard in-person outpatient clinics. The study will monitor participants through three follow-up visits at 1, 3, and 6 months after surgery. Participants assigned to online visits may switch to offline visits or withdraw from the trial if technical issues arise or additional medical care is needed. During the study, investigators collect demographic and medical information, details of symptoms and treatment, patient satisfaction, and other relevant data through questionnaires and electronic medical records. Safety is monitored through a review of medical records and participant surveys 30 days after the final follow-up. The main outcome measured is adherence to outpatient procedures, with secondary outcomes including general quality of life.

Researchers are conducting a multicenter, Phase 3, randomized, double-blinded, placebo-controlled trial to study the effects of ZL-1109 on Chinese participants with active Thyroid Eye Disease (TED). This study aims to assess the efficacy, safety, and tolerability of ZL-1109 in improving symptoms of TED, a condition that affects the eyes. The trial is sponsored by Zai Lab (Shanghai) Co., Ltd. and focuses on participants aged 18 to 75 years with moderate to severe and active TED. Participants will be randomly assigned to receive either ZL-1109 or a matching placebo through subcutaneous injections. The study includes a screening period of up to 28 days, followed by a 24-week double-blinded treatment period. After this, participants may enter an extension phase, lasting either up to 52 weeks for those who decline open-label treatment or up to 70 weeks for those who agree to receive open-label ZL-1109 if they do not respond initially. Dosing regimens vary, with ZL-1109 given every 4 or 8 weeks during the randomized period and every 4 weeks during the open-label extension. Throughout the trial, participants will undergo assessments including measurement of proptosis (eye bulging), Clinical Activity Score (CAS), and diplopia (double vision) responses at Week 24. Researchers will monitor treatment safety and tolerability, with follow-up visits during the extension period. The total participation duration depends on response status and consent to open-label treatment, ensuring detailed evaluation of outcomes and safety over an extended timeframe.

Researchers are evaluating the efficacy, safety, and tolerability of IMVT-1402 in adults with Graves' disease who remain hyperthyroid despite taking antithyroid drugs. This phase 2b, randomized, double-blind, placebo-controlled study is conducted across multiple global centers to better understand treatment options for this condition. The study is led by Immunovant Sciences GmbH and focuses on adult patients aged 18 to 75 years. Participants will receive one of three study treatments for 26 weeks: IMVT-1402 at dose 1, IMVT-1402 at dose 2, or a placebo. Each participant is randomly assigned to one of these groups without knowing which treatment they receive, ensuring an unbiased assessment. The study aims to compare these treatments based on their ability to help participants become euthyroid and stop antithyroid drug use. During the study, participants will be closely monitored through regular visits where thyroid hormone levels, including triiodothyronine (T3) and free thyroxine (FT4), will be measured. The primary outcome is the percentage of participants who achieve normal thyroid function without antithyroid drugs by week 26. Secondary outcomes include additional hormone level measurements and seronegative status. Safety and tolerability are also assessed throughout the trial, which continues until May 2027.