Thyroid Disorder

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 the efficacy and safety of IBI311, also known as Teprotumumab N01 injection, in adults with inactive thyroid eye disease (TED). This multicenter, randomized, double-masked, placebo-controlled Phase III clinical trial involves approximately 111 participants to assess how well IBI311 works compared to a placebo. The study aims to better understand treatment effects on eye protrusion and other disease symptoms over a long follow-up period. Participants will be randomly assigned to receive either IBI311 or a placebo in a 2:1 ratio. The study has two parts lasting about 64 weeks in total. Part 1 includes a screening and treatment phase lasting around 28 weeks with masked treatment. Part 2 is an open follow-up or treatment period lasting up to 36 weeks. The treatments are given by injection, and participants will be monitored closely throughout both parts. During the trial, participants will undergo regular assessments including eye examinations measuring proptosis (eye protrusion), diplopia (double vision), and clinical activity scores. Safety and tolerability of IBI311 will be evaluated through laboratory tests, imaging, and questionnaires such as the Graves' Ophthalmopathy Quality of Life survey. The primary outcome is the proptosis response rate at 24 weeks. Participants will be followed for safety and disease activity for up to about one year after treatment.

Researchers are evaluating a new dual-targeting molecular probe called 68Ga-TATE-RGD for imaging tumors that express somatostatin receptor 2 (SSTR2) and integrin 23. This study focuses on patients with tumors such as small cell lung cancer, pulmonary carcinoid, medullary thyroid cancer, and neuroendocrine tumors (NETs) that show positive expression of these receptors. The goal is to improve tumor detection and explore potential therapeutic uses of this dual-target tracer compared to existing single-target tracers. Participants will receive intravenous injections of the imaging agents 68Ga-TATE-RGD and 18F-FDG at specified doses for PET/CT and SPECT/CT scans. About 30 patients with confirmed positive expression of SSTR2 and integrin 23 will undergo imaging to assess the tracer's ability to detect tumors. The study is conducted under an early phase 1 protocol with no masking or blinding. During the study, patients will undergo PET/CT and SPECT/CT imaging within a week using the tracers. Researchers will measure tumor detection rates and standardized uptake values (SUV) over an average follow-up of half a year. Assessments include imaging evaluations and monitoring for any medical conditions affecting compliance. The total duration of participation varies but includes imaging and follow-up to evaluate diagnostic performance and tracer kinetics.

Researchers are investigating the gut microbiome in people with various serious chronic diseases such as liver cancer, gastric cancer, pancreatic cancer, lung cancer, nasopharyngeal cancer, hypertension, acute coronary syndrome, primary aldosteronism, epilepsy, chronic kidney disease, and subclinical hypothyroidism. The study aims to better understand how the gut microbiota differs across these diseases and regions and to explore the impact of these differences on microbiota-based diagnostic models. This multicenter observational study addresses the challenges caused by variability in previous research and seeks to validate microbial biomarkers in large population-based groups. Participants include patients diagnosed with one of the target diseases and age- and sex-matched healthy controls. Each participant will provide information on demographics, body measurements, lifestyle, diet, medications, diseases, and biochemistry. Samples of feces, saliva, urine, and blood will be collected from all participants. No treatments or interventions are administered, as this is an observational study. The study is designed to enroll 500 patients and 500 controls for each disease group. Participants will be involved in a one-time assessment where researchers will collect biological samples and detailed health and lifestyle information. The main outcome measure is the baseline microbiome profile, with additional assessments including baseline biochemistry, metabonomics, and proteomics. The study includes adults aged 18 to 75 years living in the hospital's province for at least three years. The entire study aims to improve understanding of gut microbiota patterns across critical chronic diseases and their diagnostic potential.

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 evaluating whether the transoral endoscopic thyroidectomy vestibular approach (TOETVA) is a safe and effective alternative to traditional open thyroidectomy for patients with benign or suspicious malignant thyroid nodules. This prospective case control study involves 40 patients divided into two groups: one receiving TOETVA and the other undergoing conventional open surgery. The study aims to assess surgical outcomes, patient satisfaction, voice quality, and swallowing function. Participants will either have surgery using the TOETVA, which is a remote access procedure through the mouth, or the traditional open thyroidectomy through the neck. The study is non-randomized, assigning 20 patients to each group. Outcomes such as lower lip numbness, skin injury, operation time, blood loss, vocal cord paralysis, and hypoparathyroidism will be monitored. The study also evaluates patient satisfaction and quality of life related to voice and swallowing using specific questionnaires. After surgery, patients will be followed up with assessments on days 1, 14, and 6 months post-operation to measure satisfaction, pain, voice, and swallowing quality of life. Surgical complications will be recorded at 2 weeks and 6 months. Secondary measures include hospital stay duration, operative time, blood loss, and conversion rates to open surgery. The total study duration spans from surgery through 6 months of follow-up.

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 compare same-day discharge with the usual overnight stay after thyroid lobectomy, focusing on differences in patient preferences, safety outcomes, and economic and resource impacts. It particularly evaluates symptom severity using the MD Anderson Symptom Inventory - Thyroid (MDASI-Thyroid) at 24 hours and 2 weeks post-procedure, along with monitoring complications such as hematoma, emergency visits, readmissions, pain levels, and mortality. Morphine use during the two weeks after surgery is also assessed. Participants will complete surveys about their symptoms before surgery, one day after surgery, and two weeks later, mainly through electronic methods. At the pre-surgery visit, patients are randomly assigned to either same-day discharge or overnight hospital stay for observation. Monitoring continues for up to one month post-surgery, including possible virtual or in-person check-ins to discuss medication use and health needs. During the study, participants will complete symptom surveys and attend standard postoperative visits around two weeks after surgery. The research team tracks adverse events graded by national criteria over an average of one year. Follow-ups may include phone or in-person visits at one month to assess recovery and medication use. The total duration of involvement includes pre-surgery, immediate post-surgery, and one month of monitoring.

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, tolerability, and effectiveness of AMG 732 in both healthy individuals and people with moderate-to-severe active Thyroid Eye Disease (TED). The study is divided into two parts: Part A focuses on single subcutaneous doses to assess safety, while Part B investigates multiple doses to evaluate efficacy in improving eye symptoms related to TED. This study includes participants aged 18 to 65 years and is sponsored by Amgen. Participants in Part A receive single ascending doses of AMG 732 or placebo through subcutaneous injections in six different groups. Part B participants receive either low, medium, or high doses of AMG 732 or placebo, also by subcutaneous injection, over approximately six months. The study involves randomized assignment to treatment groups and uses a double-masked design to ensure unbiased results. Throughout the study, participants undergo various assessments including monitoring of adverse events, blood tests to measure AMG 732 levels and antibodies, eye examinations measuring proptosis, and quality of life questionnaires related to visual function and appearance. Safety and treatment effects are followed for up to 36 weeks in Part A and up to 48 weeks in Part B. The total duration and detailed evaluations aim to provide comprehensive data on AMG 732’s impact on TED and healthy subjects.