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Showing 1-20 of 319 trials
NCT07527611
Idiopathic scoliosis (IS) is a common problem affecting approximately 3% of the population; its progression can lead to significant health problems. The BrAIST study proved brace effectiveness, which increased bracing interest and utilization globally. There is a lack of evidence-based guidelines for brace treatment. There is significant variability in the brace literature with little consistency in indications for brace treatment goals, brace types, use of monitors, timing of radiographs, and evaluation of skeletal maturity. This lack of evidence demonstrates a clear need for a multi-center brace registry. The first aim of this proposal is to develop a comprehensive retrospective brace registry. This project involves expert clinicians, researchers and an orthotist, each with broad clinical and research experience in the field of bracing for scoliosis. The retrospective registry will function as a pilot, providing strategies to optimize variables, streamline data collection and minimize missing data. The next step will be to develop and launch a multicenter, prospective brace registry and Quality Improvement registry.
NCT04666155
The primary objective is to compare the effectiveness of the experimental Intermittent Colonic Exoperistalsis (ICE) treatment with MOWOOT, with the active control of trans-anal irrigation (TAI) as standard-of-care. The secondary objectives are to further compare the ICE treatment with MOWOOT to the TAI standard-of-care clinically and economically.
NCT06789016
Effect of perineurial dexmedetomidine on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery.
NCT07516964
Nephrotic syndrome is a kidney condition that mainly affects children and is characterized by high levels of protein in the urine, low levels of protein in the blood, and swelling. While many children respond well to steroid treatment, a large proportion experience relapses or become dependent on therapy. In some cases, the disease does not respond to standard treatments and may progress to chronic kidney disease. Recent research suggests that, in addition to genetic factors, immune system mechanisms may play a key role in the development and progression of nephrotic syndrome. In particular, some patients produce autoantibodies against nephrin, an essential protein of the kidney filtration barrier. These autoantibodies may be associated with disease activity and treatment response. The aim of this study is to investigate the presence of anti-nephrin autoantibodies in children with nephrotic syndrome and to better understand their role in disease mechanisms and clinical outcomes.The study will also explore the presence of other autoantibodies targeting components of the glomerular filtration barrier. The study will use advanced laboratory techniques, including blood tests and detailed analysis of kidney biopsy samples, to identify these antibodies and their relationship with kidney structure and function. By integrating laboratory findings with clinical data, this study aims to improve the understanding of nephrotic syndrome and support the development of more personalized diagnostic and therapeutic strategies, with the goal of improving patient outcomes and reducing unnecessary or ineffective treatments.
NCT03092427
This study investigates the efficacy of probiotic VSL#3 as an add on standard care on the activity of the disease in patients with Juvenile Idiopathic Arthritis.
NCT07138157
The study aims to compare the effects of two different exercise programs, based on distinct focus strategies, on physical fitness and fatigue in children and adolescents with rheumatic diseases. Participants will include individuals diagnosed with Juvenile Idiopathic Arthritis (JIA), Juvenile Dermatomyositis (JDM), and Familial Mediterranean Fever (FMF), monitored at Istanbul University, Istanbul Faculty of Medicine, in collaboration with Istanbul University-Cerrahpaşa, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation. After baseline assessments, participants will be randomly allocated into two groups. One group will receive an exercise program with commands and instructions emphasizing external focus, while the other group will follow a program emphasizing internal focus. Both exercise interventions will last for 8 weeks, consisting of two online supervised sessions and one home-based session per week under family supervision. Final evaluations will be conducted at the clinic after completion of the intervention period.
NCT06928233
This study aims to investigate whether genetic variation in the TNFAIP3 locus is associated with immune-mediated thrombotic thrombocytopenic purpura (iTTP), and whether such association is mediated by decreased expression of A20 (TNFAIP3). The study includes a case-control design to assess genotype-expression association and a cohort study to evaluate clinical outcomes such as disease relapse.
NCT04829578
Chronic idiopathic pruritus (CIP) is a frequent and disabling condition, for which there is no specific treatment. It was shown previously that hypnosis can relieve painful sensations. Pain and pruritus share many similarities regarding sensory receptors and pathways, suggesting that hypnosis might help relief CIP.
NCT04929678
The purpose of this study was to establish probable benefits and evaluate the safety and preliminary effectiveness of the Braive™ GMS when used in the treatment of pediatric progressive scoliosis.
NCT07299695
Acute exacerbations of idiopathic pulmonary fibrosis (AE-IPF) are sudden and severe worsening episodes that can be life-threatening. Currently, no treatment has been proven to clearly improve outcomes during these events. Inflammation and immune system imbalance are thought to play an important role in causing AE-IPF. Early clinical experience suggests that intravenous immunoglobulin (IVIG) can be beneficial for patients suffering from AE-IPF. This clinical trial aims to determine whether adding IVIG to usual treatment can improve outcomes for patients hospitalized with AE-IPF.
NCT06365892
This study aims to investigate the effects of conditioning with open-label placebos on standard postoperative treatment for patients undergoing surgery for idiopathic scoliosis in a randomized controlled, 6-week trial with 64 AIS patients randomly assigned to one of two arms: Open-label Placebo (COLP) + treatment as usual TAU / TAU control. The study involves collecting data from your child's medical record. At each regular clinic visit, the patient clinical data will be collected by the research coordinator. Surveys will be collected including:• PROMIS for the age group 10 to 18 years.
NCT06718049
Literature data suggest that elevated blood values of IL-18 and IL-18 Binding Protein and alterations in their ratio may be significantly correlated with various autoinflammatory diseases, such as systemic juvenile idiopathic arthritis, recurrent autoinflammatory fevers etc. In this view, the clinical implication of this observational, prospective, single-centre, non-pharmacological study will be the definition of new laboratory markers that may be useful in the early differential diagnosis of certain rare and serious paediatric diseases.
NCT04761549
Adolescent Idiopathic Scoliosis (AIS) is a growth defect of the spine that primarily occurs in prepubertal children between the age of 10 to 14 years, affecting approximately 3% of these otherwise normal children. AIS has been associated with problems related to posture, load-related back pain, as well as aesthetic problems, e.g. the induced asymmetry of the shoulder. Therefore, early diagnosis followed by the appropriate treatment is vital to prevent further curve progression of AIS and minimize the health-related complications of these patients. The current treatment recommendation to stop curve progression for an immature patient with a scoliosis curve between 25 and 40 degrees is to wear a brace. If the curve in the skeletally immature patient is not responding to the brace treatment, dynamic scoliosis correction by vertebral body tethering can be considered when there is still some growth potential left. State-of-the-art guidelines for the selection of fusion levels are currently mainly based on two-dimensional (2D) static radiographic parameters (such as, the Cobb angle and Shoulder balance) and a qualitative assessment of 2D bending or traction radiographs. Several classification systems and algorithms that are based on the 2D static radiographic (X-ray) parameters exist to assist surgeons in determining the appropriate levels to be instrumented. Despite this wide range of classification systems and detailed guidelines available in the literature, spinal fusion does not always yield satisfying 2D radiographic clinical outcome, with revision rates ranging from 3.9% to 22%. Overall, the surgeon is presently not provided with 3D dynamic and mechanical information regarding the deformity of the AIS to guide the decision-making. Obtaining this vital 3D dynamic information regarding the curvature and mechanical behavior of the spine will allow the surgeon to make an evidence-based and well-informed decisions in the treatment of the AIS patient. Consequently, realizing these objectives has the potential to improve patient satisfaction, reduce the postoperative complications and accordingly reduce socio-economic costs associated with AIS treatment. Recent advances in the use of subject specific musculoskeletal models will form the basis to realize this shift from 2D to 3D dynamic in AIS care.
NCT06722235
Primary immune thrombocytopenia (ITP) is a condition where the immune system mistakenly destroys platelets, which are cells that help stop bleeding. This leads to a low number of platelets, making it easier to bruise or bleed. The main aim of this study is to learn whether mezagitamab, when given just under the skin (subcutaneously \[SC\]), is effective in keeping the platelet count of adults with ITP stable when compared to a placebo. A placebo looks like medicine but doesn't have any active ingredients in it. The participants will be treated with mezagitamab for up to 6 months. During the study, participants will visit their study clinic several times. Participants who complete the TAK-079-3002 study or do not have any response to study treatment by week 16 (according to study criteria) will be given the opportunity to participate in a continuation study to receive open label mezagitamab (if they are eligible and the site is able to open the continuation study).
NCT07285551
The aim of this study is to assess how physiotherapy based on the Rigo Concept, combined with WBV, affects sagittal spinal curvatures, the angle of trunk rotation (ATR), and trunk symmetry in girls with AIS. Participants undergo a 5-day individualized physiotherapy program. The exercises follow the four general principles of the Rigo Concept: three-dimensional postural correction, expansion technique, muscle activation, and integration. Therapy is delivered for 3 hours per day, with three 15-minute breaks. Additionally, participants in the Rigo Concept with WBV group perform exercises in a standing position using two poles while exposed to WBV on a Galileo Med 35 platform (Novotec Medical GmbH, Pforzheim, Germany) at a frequency of 25 Hz, with a peak-to-peak displacement of 2 mm. Each session includes three 3-minute bouts of vibration, with 3-minute rests between them. During WBV, participants perform exercises according to the principles of the Rigo Concept.
NCT00448448
Adolescent idiopathic scoliosis (AIS) is a structural curve of the spine with no clear underlying cause. Bracing is currently the standard of care for preventing curve progression and treating AIS. However, the effectiveness of bracing remains unclear. The purpose of this study is to compare the risk of curve progression in adolescents with AIS who wear a brace versus those who do not and to determine whether there are reliable factors that can predict the usefulness of bracing for a particular individual with AIS.
NCT05674994
Acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) is associated with a poor prognosis, with a 3-month mortality rate of over 50%. To date, no treatment has been proven to be effective in AI-FPI. The interest of glucocorticoids is controversial and needs to be confirmed. This confirmation is mandatory to validate the improvement of the prognosis of EA-IPF under this treatment but also to search for unsuspected deleterious effects as it has been shown with immunosuppressants in stable idiopathic pulmonary fibrosis.
NCT07440277
Background and study aims Idiopathic intracranial hypertension (IIH) is a neurological condition characterised by increased pressure inside the skull, called intracranial pressure (ICP). It is more common in women of reproductive age with obesity. Common symptoms of IIH include headaches, blurred vision and ringing in the ears. If left untreated, the disorder may cause blindness. The majority of patients with IIH are managed with weight loss and medications. Fewer than 10% of patients develop progressive visual loss and require urgent intervention to reduce ICP and preserve vision. This trial will compare the two most common interventions performed in the UK and evaluate their clinical and cost-effectiveness. The first is called cerebrospinal fluid (CSF) shunting and involves a procedure where a thin tube called a shunt is implanted in the body to drain brain fluid. The second is called dural venous sinus stenting (DVSS) and involves a procedure where a metallic mesh tube called a stent is implanted inside a brain blood vessel. Both procedures can preserve vision, but there is no strong evidence to support one over the other. Participants will have the same chance to be treated with CSF shunting or DVSS. The aim of the trial is to know which intervention is the most effective to save the vision and the most cost-effective. Who can participate? Adults with a diagnosis of IIH at risk of permanent sight loss What does the study involve? The trial will be conducted in NHS hospitals located in England, Wales and Scotland. Participants are randomly allocated to undergo cerebrospinal fluid (CSF) shunting or dural venous sinus stenting (DVSS). Afterwards the participants will be asked to attend 11 hospital appointments and one telephone appointment. This follow-up will take 2 years from start to finish. Participants will be closely monitored for any side effects and potential device failure, and for changes in vision, headaches and quality of life. The researchers will also collect health data from NHS Digital (the national custodian of NHS health and social care data). What are the possible benefits and risks of participating? There are no direct benefits from taking part in the trial but the information gained from this trial may help improve treatment for adults with IIH in the future. Participants may be seen more often and/or feel more supported as a consequence of their involvement in the trial. As with any intervention, there are risks and complications, but there are no additional disadvantages or risks involved in taking part in this trial. Both CSF shunting and stenting are treatments for IIH (shunting is widely used internationally, and in some hospitals, stenting is used as part of the standard of care). Participants require an intervention to prevent sight loss. None of these treatments is experimental but at present, there is not enough information to determine which treatment is most suitable and provides the higher level of health benefits to the individual. Where is the study run from? University of Birmingham (UK) When is the study starting and how long is it expected to run for? The first site opened in July 2023, and the last patient last visit is expected in May 2028 Who is funding the study? National Institute for Health Research (NIHR, grant number: NIHR131211) (UK) Who is the main contact? IIH Intervention Trial manager, IIHIntervention@trials.bham.ac.uk (UK)
NCT04800367
The overarching goal of the research program is to define optimal treatment for premenopausal women with clinically significant fracture syndromes that require medical therapy. The investigators hypothesize that romosozumab will be associated with improvements in bone mass and microarchitecture in premenopausal women, and also that the responses and response rates will exceed those observed in premenopausal women treated with teriparatide. The investigators will test this hypothesis in this phase 2 study of 30 premenopausal women with idiopathic osteoporosis (IOP) who will receive 12M of romosozumab 210 mg monthly followed by 12M of denosumab 60 mg SC q6M. Aim 1 will define the within-group effects of this regimen. Aim 2 will compare results from participants treated with romosozumab-denosumab to the investigator's well-characterized historical controls treated with teriparatide followed by denosumab.
NCT07426107
This study employs a dual-cohort design to develop and validate a prognostic model for Major Adverse Cardiovascular Events (MACE) following revascularization in immune thrombocytopenia (ITP) patients with Coronary Artery Disease (CAD). The model will be developed and trained using a retrospective multi-center cohort (development/training cohort). Its performance will then be prospectively validated in a separate, consecutively enrolled prospective cohort (validation cohort). The goal is to create an AI-based tool to assist in personalized risk assessment and decision-making for this high-risk population.