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Graves Disease clinical trials

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NCT ID: NCT03980132 Completed - Clinical trials for Hyperthyroidism, Autoimmune

Preoperative Preparation With Lugol Solution in Patients With Graves-Basedow Disease.

LIGRADIS
Start date: November 25, 2019
Phase: Phase 4
Study type: Interventional

Currently, both the American Thyroid Association and the European Thyroid Association recommend the use of Lugol Solution (LS) in the preparation of patients undergoing thyroidectomy for Graves' disease (GD), but their recommendations are based on a low level of evidence. This means that its use is not generalized among the different endocrine surgery units. Methods: Study population: 270 patients (135 patients in each arms) undergoing total thyroidectomy (TT) due to GD in Spanish hospitals, which perform a minimum of 100 thyroidectomies a year, at least 10 of them for GD. Variables: Preoperative variables - Demographic variables: birthdate, gender and ethnicity. - Drugs allergies. Allergy to iodine. - Personal history and usual treatment. - Aspects related to the GD: date of diagnosis, use of AT drugs and/or radioiodine, existence of ophthalmopathy, existence of cervical compression symptoms and indication of surgery. - Physical exploration: body mass index, pulse at rest and blood pressure and cervical palpation. - Laboratory tests: hematocrit, leukocytes, neutrophils, platelets, international normalized ratio(INR), creatinine, potassium, total calcium, albumin, total proteins, parathormone (PTH), 25-hydroxide-vitamin D, free T4 and / or free T3, TSH, thyroid stimulating immunoglobulin (TSI). - Classification of the anesthetic risk of ASA. - Cervical ultrasound: existence of thyroid nodules and volume of the thyroid. - Mobility of the vocal cords evaluated by laryngoscopy. - Compliance with assigned treatment: the patient assigned to the LS arm must have consumed at least 80% of the total dose indicated. Intraoperative variables - Surgical time. - Antibiotic prophylaxis - Intraoperative hemorrhage. - Thyroidectomy Difficulty Scale. - Loss of electromyographic signal during neural intraoperative monitorization. - Accidental parathyroidectomy. - Section or obvious lesion of the recurrent laryngeal nerve. - Trachea or esophagus perforation. - Weight of the gland. - Electrosurgical hemostasis system used during the intervention. - Maneuvers used to check hemostasis. - Hemostats used during the intervention. - Use of drainage. - Definitive surgical technique: TT, unilateral or bilateral subtotal thyroidectomy or hemithyroidectomy. Postoperative variables - Early complications: hypoparathyroidism, paralysis of the recurrent laryngeal nerve, postoperative hematoma, surgical site infection or death. - Debit for surgical drains. - Postoperative hospital long of stay. - Anatomopathological variables: histological diagnosis compatible with GD and existence of parathyroid glands in the surgical specimen. - Long-term complications: hypocalcemia and/or permanent vocal cord paralysis longer than 6 months

NCT ID: NCT03969108 Completed - Thyroid Cancer Clinical Trials

Diagnostic Accuracy Study of Indocyanine Green for Parathyroid Perfusion Assessment

Start date: August 6, 2019
Phase: Phase 4
Study type: Interventional

This study aims to develop a standardized universal imaging protocol for ICG-guided fluorescent total thyroidectomy, including quantitative evaluations of the fluorescent signal. Therefore, patients will undergo thyroid surgery (total thyroidectomy) with the use of ICG fluorescence.

NCT ID: NCT03941184 Completed - Clinical trials for Rheumatoid Arthritis

Spontaneous Coronary Artery Dissection (SCAD) and Autoimmunity

Start date: January 1, 1995
Phase:
Study type: Observational

This case control study aims to determine whether spontaneous coronary artery dissection (SCAD) is associated with autoimmune diseases and to update the incidence of SCAD in a population-based cohort.

NCT ID: NCT03667157 Completed - Liver Diseases Clinical Trials

Liver Function After Intravenous Methylprednisolone Administration

Start date: January 1, 2012
Phase: Phase 4
Study type: Interventional

Graves' orbitopathy (GO) is a characterized by orbital soft tissue inflammation and oedema associated with glycosaminoglycan deposition and fibrosis. The most frequent cause is Graves' disease. The classification is comprised based on the severity of orbital changes ranging from mild, moderate-to-severe GO and sight-threatening GO, which includes dysthyroid optic neuropathy (DON). Intravenous methylprednisolone (IVMP) pulse therapy is the first-line treatment in the active-phase of moderate-to-severe GO and DON. This therapy is more effective and better tolerated than oral glucocorticoids (GCs). The current recommendation of the European Group of Graves' Orbitopathy (EUGOGO) is that cumulative doses of IVMP should not exceed 8.0g in each treatment course, and pulses should not be given on consecutive or alternate days, except in the case of DON. According to EUGOGO recommendations patients with moderate-to-severe GO are treated with IVMP cumulative dose 4.5g during a 12-week period (for the first 6 weeks 0.5g IVMP per week, for the next 6 weeks 0.25g IVMP per week). According to EUGOGO recommendations patients with DON should receive 3.0g IVMP (1.0g/day for 3 consecutive days) as the basic treatment. This limitation in doses are due to the necessity of the prevention of severe side effects that are rare but may be fatal. One of the most severe adverse events is acute liver injury (ALI), in some cases irreversible and/or fatal. The estimated morbidity and mortality of ALI was found to be 1-4 % and 0.01-0.3%, respectively. Since 2000, there were 5 reported fatal cases. Mechanisms causing an IVMP-induced ALI remains incompletely elucidated. There are some possible hypotheses that may explain the occurrence of ALI. Firstly, GCs can lead to reactivation of autoimmune hepatitis: an immune "rebound phenomenon" following GCs withdrawal. The second mechanism of ALI is reactivation of viral hepatitis. Finally, there is well known direct toxic effect of GCs on hepatocytes, probably dose-dependent. This study was performed to evaluate the influence of two different, routinely used schemes of therapy with IVMP in patients with moderate-to-severe GO (first scheme) and DON (second scheme) on biochemical liver parameters. Patients included into the study were treated according to EUGOGO recommendations with routine doses of IVMP and routine scheme of administration for moderate-to-severe GO and DON. No additional treatment was performed during the study protocol.

NCT ID: NCT03590080 Completed - Hypertension Clinical Trials

Impact of Intravenous Methylprednisolone Treatment on Blood Pressure

Start date: January 1, 2011
Phase:
Study type: Observational

Hypertension is common side effect of Cushing Syndrome (CS): in patients with endogenous CS and those treated with glucocorticosteroids (GCs). The impact of the intravenous GCs therapy on blood pressure (BP) remains unclear. According to the European Group On Graves' Orbitopathy (EUGOGO), patients with active, severely symptomatic and sight-threatening Graves' orbitopathy (GO) should be treated with high dose intravenous methylprednisolone (IVMP) pulses. There are, however, reports of fatal side effects that may be associated with this therapy (e.g.: pulmonary embolism, myocardial infarction, severe cerebrovascular events, acute liver damage and sudden death). For this reason, the cumulative dose of IVMP should not exceed 8 g within each treatment course, and pulses should not be given on consecutive or alternate days, except for the case of dysthyroid optic neuropathy. A consensus on the monitoring of patients during and after IVMP pulse administration is not yet established. What is more, there is lack of paper regarding pattern of blood pressure at various time points during and after ivGCs administration. Thus, the investigators decided to evaluate acute changes of N-terminal pro-brain natriuretic peptide (NT-proBNP) as a marker of hemodynamic stress and to monitor BP before, during and after IVMP pulse administration. All of patients were treated routinely according to EUGOGO recommendations with standard doses of methylprednisolone with standard recommended schedule. Inclusion criterion for the therapy was according to EUGOGO guidelines active, moderate-to-severe and active GO (12 pulses of IVMP 6x0.5g followed by 6x0.25g every week).

NCT ID: NCT03535090 Completed - Clinical trials for Venous Thromboembolism

Coagulation After Intravenous Methylprednisolone Administration

Start date: January 1, 2011
Phase:
Study type: Observational

The alterations of coagulation and fibrinolysis parameters have been described in patients with endogenous Cushing's syndrome (CS) and those treated with glucocorticosteroids (GCs). The change in hemostatic process is associated with an increased risk of venous thromboembolic events (VTE) and pulmonary embolism (PE). Anticoagulation prophylaxis reduces thromboembolic complications in endogenous and exogenous hypercortisolism. The impact of the intravenous GCs therapy on hypercoagulability, however, remains unclear and perplexing. According to the European Group On Graves' Orbitopathy (EUGOGO), patients with active, severely symptomatic and sight-threatening Graves' orbitopathy (GO) should be treated with high dose intravenous methylprednisolone (IVMP) pulses. There are, however, reports of fatal side effects that may be associated with this therapy (e.g.: PE, myocardial infarction, severe cerebrovascular events, acute liver damage and sudden death). For this reason, the cumulative dose of IVMP should not exceed 8 g within each treatment course, and pulses should not be given on consecutive or alternate days, except for the case of dysthyroid optic neuropathy. Nevertheless, even smaller cumulative therapy may be associated with fatal cardiovascular complications. Hence the aim of our study was to evaluate the effects of IVMP therapy on hemostatic process in patients with GO. All of patients were treated according to EUGOGO recommendations with standard doses of methylprednisolone with standard recommended schedule. Inclusion criterion for the therapy was according to EUGOGO guidelines moderate-to-severe and active GO (12 pulses of IVMP 6x0.5g followed by 6x0.25g every week).

NCT ID: NCT03517579 Recruiting - Thyroid Cancer Clinical Trials

Personalized Treatment in Thyroid Disorders

Start date: December 11, 2018
Phase: N/A
Study type: Interventional

The Collar Therapy Indicator (CoTI) (A device that is placed in collar around the neck resembling a turtle neck sweater collar with a wire and recording box) has been shown in a single small previously published experience to provide data regarding radioiodine exposure that correlates with conventional methods of measuring I-123 and I-131 uptakes after diagnostic dose administration and/or therapy for thyroid disorders. We hypothesize that the device's continuous measurement capability will permit more accurate estimates of radiation exposure to thyroid tissue than conventionally employed methods assessing fractional uptake at one or a few time points. It may also provide information about the extent of variability in the absorbed radiation dose among patients with thyroid cancer and hyperthyroidism. By providing more complete information about individual patient's exposures, it will facilitate more accurate estimation of the administered I-131 dose requirements for control of hyperthyroidism and thyroid remnant ablation while reducing the need for repeated visits to the clinic for dosimetry measurements. The aims of our project include the following: (1)To compare quantitative imaging-derived thyroid time activity curve to that obtained using the CoTI and to determine the extent to which there is variability in radiation dose predicted using conventional methods to that predicted from measurement of the full Time-Activity Curve (TAC).(2) Evaluate the uptake and clearance kinetics across the 5 patients in each category as proof of principle for a potential larger trial to investigate use of this device in optimizing the administered doses of radioactive iodine to achieve therapeutic goals while minimizing risks of comorbidities, such a post-radioiodine hypothyroidism in patients with Graves' disease.(3)Evaluate patient experience, convenience, and discomfort in using the CoTI device with a survey instrument.

NCT ID: NCT03498417 Completed - Graves Disease Clinical Trials

Anti-insulin-like Growth Factor-1 Receptor (IGF-1R) Antibodies in Graves' Disease and Graves' Orbitopathy

IGF1RAbsGO
Start date: June 20, 2018
Phase:
Study type: Observational

The study is aimed at assessing IGF-1R-Abs in patients with Graves' disease, with or without GO, compared with healthy subjects and patients with autoimmune thyroiditis in a cross-sectional investigation.

NCT ID: NCT03324334 Not yet recruiting - Ulcerative Colitis Clinical Trials

Prevalence of Graves Disease in Patients With Ulcerative Colitis

Start date: November 1, 2017
Phase: N/A
Study type: Observational

Graves disease in ulcerative colitis: The connection between Graves disease and Inflammatory bowel disease is well known in the literature, but thyroid disorders have not been considered extra-intestinal manifestations of ulcerative colitis. In most cases, the diagnosis of thyroid disease has preceded that of Inflammatory bowel disease. Early studies have suggested a relationship between thyroid abnormalities and ulcerative colitis . But it is still uncertain whether the coexistence of Grave's and ulcerative colitis diseases is due to a specific reason or a coincidence.

NCT ID: NCT03303053 Recruiting - Graves Disease Clinical Trials

Efficacy and Safety of Cholestyramine and Prednisolone as Adjunctive Therapy in Treatment of Overt Hyperthyroidism

ChoPS
Start date: May 11, 2017
Phase: Phase 3
Study type: Interventional

Hyperthyroidism is the second most common endocrine disorder in the world with Graves' disease being the commonest. Anti thyroid drugs including methimazole, carbimazole, and propylthiouracil are effective treatments but take in most cases between 6 to 8 weeks to achieve euthyroidism. This study aim to assess the efficacy of cholestyramine and prednisolone as adjunctive treatment to standard treatment in patients with overt hyperthyroidism in 4 weeks.