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Filter by:This is a single-center, prospective, randomized, double-blind (pharmacotherapy), placebo-controlled, and comprehensive rehabilitation phase II clinical trial to determine the usefulness of pregabalin in a new indication (post-COVID chronic fatigue syndrome). Patients will be randomized in a 1:1:1:1 ratio to pregabalin (75-300 mg daily in two divided doses), comprehensive rehabilitation with a placebo drug, comprehensive rehabilitation with pregabalin (75-300 mg in two divided doses), or placebo (two divided doses) for 6 months (177-187 days). There will be 4 outpatient visits to the research center and 12 telephone consultations. The procedures and assessments performed as part of the study are listed in the study schedule. It is planned to include 132 patients in the study, which, assuming a 10% level of non-completion of the program, will result in the examination of 120 patients (30 in each arm). Patients will be recruited during an outpatient medical consultation with a general practitioner or neurologist, psychiatrist, psychologist or other specialists, as well as with the use of information materials in the form of leaflets and advertisements on the Internet.
Dapagliflozin is the first SGLT2 inhibitor to be approved for CKD treatment regardless of diabetes status. Since many etiologies of non-diabetic nephropathy are characterized by intraglomerular hypertension, it was hypothesized that dapagliflozin acutely decreases GFR and proteinuria in patients without diabetes at risk of progressive kidney function loss such as nephrotic patients via a glucose independent hemodynamic mechanism. The aim of the study is to assess the effect of Dapagliflozin on proteinuria and estimated glomerular filtration rate in non-diabetic patients with nephrotic syndrome in order to slow the decline in kidney function and the progression to ESRD and to prevent the complications of nephrotic syndrome like thrombotic diseases, peritonitis, hyperuricemia, and recurrent infections.
Chronic inflammation is the core of Polycystic ovary syndrome (PCOS), and obesity and overweight further exacerbate the level of inflammation in the peripheral circulation and ovarian tissue in PCOS patients. Metformin is a classic endocrine drug for the treatment of PCOS, but its clinical response rate is only about 40%. Our previous published study (Diabetes Obes Metab, 2022) observed that the new hypoglycemic drug SGLT-2 inhibitor can significantly improve the clinical symptoms of patients with insulin resistance PCOS, and the clinical efficacy is not inferior to metformin, but its specific mechanism of action is not clear. Recent studies have shown that SGLT-2 significantly attenuates the activation of the Nod-like receptor protein 3 (NLRP3) inflammasomes and the secretion of IL-1β in patients with type 2 diabetes mellitus at high risk of cardiovascular disease. Based on the above research background, this project will combine clinical research and mechanism exploration to solve the following two problems: 1. whether SGLT2 inhibitor can further improve the clinical efficacy of PCOS patients compared to metformin; 2. mechanistic studies further clarify whether SGLT2 inhibitors improve inflammatory symptoms by modulating NLRP3 inflammosomes in the treatment of polycystic ovary syndrome;
Polycystic Ovary Syndrome (PCOS) is a complex endocrine disorder characterized by hyperandrogenism, insulin resistance, and ovulatory dysfunction. One of the diagnostic criteria for PCOS is the presence of polycystic ovaries, which are enlarged ovaries with multiple follicles on ultrasound. However, the mechanisms that lead to the development of polycystic ovaries in PCOS are not completely understood. One potential area of investigation is the role of ovarian innervation in the pathophysiology of PCOS. Therefore, the aim of this study is to evaluate the ovarian innervation in PCOS patients through ovarian biopsy sampling.
Subacromial Impingement Syndrome (SSS) is one of the most common shoulder problems. The core region is considered a kinetic link that facilitates the transfer of torque and angular momentum between the upper and lower extremities during body movements. The decrease in core stabilization affects both trunk control and the quality of extremity movements depending on the kinetic chain in the body. The improvement in core stabilization balances the load transfer between the trunk and the extremities and reduces the asymmetry between the extremities. Core stabilization training should be included in rehabilitation programs as core stabilization is adversely affected in patients with CNS. For this reason, this study was planned to examine the effects of core stabilization training applied in addition to conventional treatment in patients with CNS on pain, range of motion, upper extremity function and core stability.
Fibrous Dysplasia/McCune-Albright syndrome (FD/MAS) is a rare disease, consisting of the replacement of normal bone tissue with fibrous tissue. FD lesions may be isolated in one or more bones or may be associated with endocrinopathies in McCune-Albright syndrome. Bone lesions constitute of weak bone tissue, leading to higher risk of fractures, pain and decreased quality of life. There is no cure for FD lesions and current therapies failed to soothe patients' complaints or to display any effect on progression of the lesions on imaging. However, the RANKL-inhibitor Denosumab demonstrated encouraging results in mouse models and in off-label clinical use, leading to clinical, biochemical and radiographical improvements. Study's aim is to investigate whether 3-monthly Denosumab will improve the clinical, radiological and biochemical manifestations of FD bone lesions.
This study will use electromyography and nerve conduction studies to evaluate median nerve function during the Phalen's wrist flexion test in different wrist positions.
The objective of this study to evaluate the safety and effectiveness of the Castor single branch stent graft for endovascular repair of acute aortic syndrome patients without an inadequate proximal landing zone (<15mm)
Children and adolescents with inherited cardiac arrhythmia su ch Long QT Syndrome (LQTS) have lower physical and quality of life than their healthy peers. A multi-component cardiac rehabilitation, including an exercise training program and education program, might counteract those effects. The goal of this pilot study is to evaluate the security, feasibility, and benefits of a cardiac rehabilitation program in children with LQTS aged between 6 to 18 years old. The main question[s] it aims to answer are: - Is center-based cardiac rehabilitation safe and feasible for children with LQTS? - Does a 12-week cardiac rehabilitation program improve physical fitness and quality of life?
Lynch syndrome (LS) is the most common genetic predisposition syndrome for colorectal cancer (CRC), responsible for around 2-4% of cancers. It is characterized by a pathogenic germline mutation in one of the DNA mismatch repair genes (path_MMR) MLH1, MSH2, MSH6, PMS2 or a deletion in the 3' region of the Epcam gene. Patients followed up for LS are at high risk of developing CRC at an early age, and have a high cumulative CRC risk. In this context, CRC screening by colonoscopy is of major importance, as it is associated with a reduction in both CRC incidence and mortality. In France, the Institut National du Cancer (INCa) recommends colonoscopy with indigo carmine chromoendoscopy (CE), as it is associated with a significant increase in the adenoma detection rate (ADR) compared with white light. However, EC is not routinely performed in clinical practice, as it is a time-consuming technique requiring a dedicated slot with a trained operator. Recent years have seen the emergence of artificial intelligence techniques for real-time polyp detection aids or CADe devices. These easy-to-use systems have shown very promising results compared with high-definition (HD) white light. Indeed, data from the first meta-analysis of 5 randomized controlled trials (4354 patients) confirmed a significantly higher ADD in the CADe group than in the HD group (36.6% vs. 25.2%; 95% CI], 1.27-1.62; P < 0.01; I2 Z 42%) 10. The CAD EYE system (Fujifilm) is a CADe device supporting both detection (sensitivity > 95%) and characterization of colonic polyps in real time. To date, artificial intelligence has never been evaluated for CRC screening in patients followed up for LS. The aim of this work is to evaluate the effectiveness of the CAD EYE system in this specific population. To this end, we intend to conduct a randomized, controlled, non-inferiority trial comparing CAD EYE with CE in patients with LS.