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NCT05228184
This is a multi-center, prospective, parallel-group, open-label, randomized clinical study in one hundred and twenty-six (126) neonates and infants diagnosed with CH. Subjects will be randomized in a 2:1 ratio to Treatment (Tirosint®-SOL) or Control (conventional therapy with levothyroxine sodium crushed tablets).
NCT00001159
Participants in this study will be patients diagnosed with or suspected to have a thyroid function disorder. These conditions may include: hypothyroidism, hyperthyroidism, thyroid hormone resistance, Graves' Dermopathy, and thyroid-stimulating hormone (TSH) secreting pituitary adenomas. The main purpose of this study is to further understand the natural history, clinical presentation, and genetics of thyroid function disorders. Many of the tests performed are in the context of standard medical care that is offered to all patients with thyroid function disorders. In addition, blood and tissue samples may be taken for research and genetic studies.
NCT06960005
Objectives: This study aims to assess health-related quality of life (QoL) in adults with thyroid hormone disorders and identify modifiable factors to improve QoL in patients with Hashimoto's thyroiditis (HT) and multinodular toxic goiter (MNTG) through an exercise intervention. Primary Outcome: 1\. Assess the impact of a tailored exercise program on health-related QoL in patients with HT and MNTG using the ThyPRO questionnaire. Secondary Outcomes: 1. Evaluate the need for a screening tool to identify thyroid patients with reduced health-related QoL despite being euthyroid. 2. Assess the impact of the exercise intervention on body composition, strength, and balance function in HT and MNTG patients. Methods: The study is a combined cross-sectional survey and randomized controlled trial into the health related QoL in patients diagnosed with thyroid hormone disease. The cross-sectional survey will assess the overall health-related QoL in patients diagnosed with thyroid hormone disease, and help identify eligible participants for the subsequent RCT. The RCT will evaluate the efficacy of a comprehensive screening and exercise intervention in patients ≥ 65 years diagnosed with HT or MNTG, experiencing reduced health-related QoL. Participants: The aim is to recruit 74 patients with HT and 74 patients with MNTG, including 50 participants from each group with reduced health-related QoL (defined in this study as ThyPRO score ≥ 30) and 24 with good health-related QoL (ThyPRO score ≤ 20)
NCT07408765
Background. Primary hypothyroidism, both clinical and subclinical, is frequently associated with persistent fatigue, reduced psychological well-being, and lower levels of physical activity in adult women. However, evidence integrating these psychosocial factors remains limited and methodologically heterogeneous. Objective. To analyze the association between physical activity and fatigue, social support, and psychological well-being in women with primary hypothyroidism; to compare these profiles between clinical and subclinical hypothyroidism; and to explore the moderating effect of social support and psychological well-being on the relationship between fatigue and physical activity. Methods. An observational, analytical, multicenter cohort study will be conducted including 96 adult women with primary hypothyroidism from the Principality of Asturias. Physical activity levels will be assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF), while fatigue, social support, and psychological well-being will be measured using the Fatigue Severity Scale (FSS), the Medical Outcomes Study Social Support Survey (MOS-SSS), and the WHO-5 Well-Being Index, respectively. Confounding variables will include age, body mass index, type of hypothyroidism (clinical or subclinical), and time since diagnosis. Descriptive analyses, comparisons between clinical and subclinical groups, and multiple linear regression models will be performed. Expected results. The study is expected to identify physical activity levels within the sample and determine which psychosocial factors are independently associated with physical activity. Additionally, fatigue is anticipated to be negatively associated with physical activity, whereas social support and psychological well-being are expected to show positive associations and potential moderating effects.
NCT05712421
The North Star study is a multi-center, Phase 2, double-blind, randomized, parallel group clinical study to evaluate the safe and effective dose conversion from Levothyroxine to North Star therapy.
NCT07380854
The goal of this clinical trial is to find out whether levothyroxine reduces complications and improves the prognosis of patients with subclinical hypothyroidism (SCH) undergoing coronary artery bypass grafting (CABG). The main questions this study aims to answer are: • Does levothyroxine reduce major adverse cardiovascular events (MACE), including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and new arrhythmias, in SCH patients undergoing CABG? Researchers will compare patients who take levothyroxine with those who do not. Participants will: * Be randomly assigned to either receive levothyroxine or not * Start the medication one day before surgery if assigned to the treatment group. * Have regular follow-up visits to check thyroid function and cardiovascular events for up to five years after surgery.
NCT07323706
Primary hypothyroidism is diagnosed by elevated thyroid stimulating hormone (TSH) level and a reduced thyroxine (T4) level in plasma. Some of the most common symptoms of hypothyroidism are fatigue, weight gain and reduced cognition and is associated with reduced quality of life and increased days of sick leave. Levothyroxine, a synthetic form of T4, is clinically recommended as first-line treatment for hypothyroidism. When normalizing TSH/T4 with levothyroxine, the prevalence of persistent symptoms is present in 15% of patients. The composition of our gut bacteria, the microbiome, plays a significant role for a healthy thyroid gland and metabolism and is influenced by our diet. The Indian medical system, Ayurveda, is based on generations of experience and knowledge in disease prevention and treatment, including various diet plans, exercise and lifestyles that are put into context for physical and mental health. Ayurveda works with four different types of digestion and is based on a vegetarian diet. The purpose of this study is to investigate the effect of an Ayurvedic diet plan, as a supplement to medical treatment, among people with hypothyroidism.
NCT06083636
Hypothyroidism is a thyroid disorder and one of the most common endocrine disorders. Hypothyroidism can have multiple causes; most patients suffer from primary autoimmune hypothyroidism (Hashimoto's disease), but also central hypothyroidism, hypothyroidism after total thyroidectomy due to thyroid carcinoma, or hypothyroidism due to therapy of Graves' disease occur. Most patients with hypothyroidism are treated with levothyroxine (L-T4) to supplement the lack of thyroxine (T4) produced by their own thyroid. Serum thyroid-stimulating hormone (TSH) and/or free T4 (fT4) are currently measured to assess the efficacy of this therapy and to establish euthyroidism. It is known that fT4 concentrations in patients using L-T4 can be above the upper limit of the reference interval, while their TSH is not (completely) suppressed. This raises the question whether fT4 is an accurate reflection of thyroid hormone status in patients using L-T4. TSH is considered a reliable parameter of thyroid hormone status; however, TSH cannot be used to assess thyroid function in specific hypothyroid patient groups (e.g. central hypothyroidism). Free triiodothyronine (fT3), the active thyroid hormone, has been suggested to be an interesting alternative of fT4 to assess thyroid function. Previously, the methods to measure fT3 were not that robust; however, methods to determine fT3 have been improved, are currently reliable and not susceptible to changes due to L-T4 intake. In addition, the fT3/fT4 ratio is thought to be an interesting candidate in assessing thyroid hormone status as well. The aim of this study is to improve laboratory diagnostics of thyroid hormone status in patients with hypothyroidism receiving L-T4 in whom TSH cannot be used as a reflection of thyroid hormone status. We will primarily investigate the additional already available laboratory tests fT3 and fT3/fT4 ratio. We hypothesize that treated hypothyroid participants who are assumed euthyroid based on TSH (e.g. patients with Hashimoto's hypothyroidism) but have fT4 concentrations above the upper reference limit will more often have a fT3 level or a fT3/fT4 ratio within the reference interval. Concentrations of alternative markers in healthy controls and patients with Hashimoto's hypothyroidism with 'normal' TSH concentrations can, thus, be used to predict thyroid hormone status in patients using L-T4 in whom TSH cannot be used to assess thyroid hormone status.
NCT07205042
Women with hypothyroidism often report persistent fatigue, weight gain, autonomic dysregulation, and stress despite stable levothyroxine therapy. This single-center, parallel-group RCT will test whether a structured, supervised 12-week walking program improves basal metabolic rate (BMR) and psychophysiological outcomes compared with usual activity. One hundred twenty women aged 35-55 with stable primary hypothyroidism will be randomized 1:1 to intervention or control.
NCT06757712
This study will be conducted to compare between the effect of nonlinear and linear periodized training on quality of life in females with hypothyroidism.
NCT01916018
Congenital hypothyroidism (CH) is a rare disease that affects 1 in 3500 newborn. This condition is detected consistently since the late 1970s in France, which has led to early care and a significant improvement in prognosis and intellectual stature of these children. However neurodevelopmental disorders persist in 10-15% of cases. More associated diseases have been reported in approximately 10% of cases. These observations are in most cases poorly understood. The family nature of the CH is now well recognized and a dozen genes involved up to now. However, in the majority of cases (HC not due to a disorder of the organification of iodine), few mutations have been found in the reported number of patients (5-10%), suggesting the involvement of other genes. Some of the genes have been implicated in particular specific syndromic forms but many pathological associations remain unexplained. Also, a more complete genetic elucidation of CH would enable a better understanding of its etiology and thus its risk of familial recurrence (frequently asked questions by parents of children with CH) and secondly the presence of associated pathologies. Main goal: to describe the population with CH (not due to a disorder of the organification of iodine) not only on clinical, biological and radiological (phenotypic analysis) but also on the genetic level to establish a genotype / phenotype correlation.
NCT07133295
Hypothyroidism is a prevalent endocrine disorder characterized by insufficient production of thyroid hormones. Traditional treatment involves daily administration of levothyroxine (L-T4), which can be challenging for some patients due to adherence issues. Recent studies have explored the efficacy of once-weekly L-T4 regimens, suggesting that they may provide a viable alternative for patients struggling with daily dosing The safety profile of once-weekly L-T4 has also been a focus of recent research. Evidence indicates that this regimen is associated with minimal side effects and is well-tolerated by patients. A comparative study found that once-weekly L-T4 did not result in significant adverse effects compared to daily dosing, reinforcing its potential as a safe treatment option
NCT03779906
This is a Phase IV prospective, multicenter, observational study to estimate the proportion of subjects 0 to 3 years of age who develop abnormal thyroid function after exposure to intravascular administration of ISOVUE for the required radiologic procedure as part of their standard of care.
NCT05581147
This is a longitudinal retrospective study for the evaluation of thyroid function and structure in patients with Klinefelter syndrome compared to healthy controls and patients affected by chronic lymphocytic thyroiditis.
NCT06276205
The goal of this clinical trial is to study the improvement of lipid levels in hypothyroid individuals after staring treatment. The main question it aims to answer is: • whether adding Vitamin D to standard therapy has any additional benefits Participants will be given Vitamin D in replacement doses according to their pre-existing Vitamin D level in addition to levothyroxine. Researchers will compare them with another group receiving only levothyroxine to see how much lipids improve in them
NCT05682482
Hypothyroidism is common, affecting 5% of the general population, for which levothyroxine (LT4) monotherapy is the standard treatment. Despite normalized serum thyroid hormone levels, 10-15% of LT4 treated patients have various persistent complaints, the most important of which is tiredness. This could be explained by the fact that physiological T4/T3 ratios cannot be reached with LT4 monotherapy, as in a healthy individual T3 is not only derived from T4/T3 conversion but is also directly produced by the thyroid itself. Studies have reported contradicting results as to whether addition of liothyronine (LT4/LT3 combination therapy) in patients with persistent tiredness on LT4 monotherapy is effective or not. Studies have suggested higher effectiveness in patients carrying genetic variation in the type 2 deiodinase (DIO2-rs225014) and monocarboxylate transporter 10 (MCT10-rs17606253) genes. Objective: To investigate whether addition of liothyronine (LT4/LT3 combination therapy) in in patients with persistent tiredness on LT4 monotherapy is effective or not in relieving tiredness.
NCT06826248
STUDY OBJECTIVES 1. To assess the safety of Darqeen capsule for the management of Hypothyroidism 2. Evaluate the efficacy of Darqeen capsule for the management of Hypothyroidism 3. To provide an alternative cost-effective treatment for the management of females suffering from hypothyroidism. NULL HYPOTHESIS (HO) The Unani Medicine Darqeen capsule is not effective for the management of Hypothyroidism. ALTERNATE HYPOTHESIS (H1) Unani medicine Darqeen capsule is effective for the management of Hypothyroidism.
NCT04831957
Aortic stenosis is highly prevalent in advancing age. The prognosis of this disease has dramatically changed with the surgical replacement of the aortic valve and the trans catheter aortic valve re-placement (TAVI). The TAVI procedure is also successful in octogenarians and frail patients. However, the evaluation before the TAVI procedure requires a high dosage of iodinated contrast agent with, consequently, an increased risk for thyroid dysfunction. The primary endpoint of this study is to assess, prospectively, the incidence and the predictive factors (underlying thyroid disease, medication, food preservative, topical antiseptics) of hypothyroidism after a TAVI procedure. The secondary endpoint is the influence of the occurrence of hypothyroidism after the TAVI procedure on the geriatric assessment.
NCT06699069
The aim of study was to evaluate the role of exercise on serum irisin levels in hypothyroid rats.
NCT06583395
This study will be focused on assessing the molecular, physiological, and emotional correlates of an intensive meditation experience in the context of a retreat setting in a large 2000 plus-person cohort comprised of healthy and clinical populations.