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Arthritis clinical trials

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NCT ID: NCT05679232 Recruiting - Arthritis Clinical Trials

Hydrogel Coating to Reduce Post-surgical Infection After Joint Arthroplasty

Start date: December 6, 2022
Phase: N/A
Study type: Interventional

The goal of this randomized, controlled, monocentric, single-blind, 2-arm, feasibility clinical investigation is to evaluate the safety of MectaShield hydrogel coating and to capture its preliminary clinical performance in the prevention of early peri-prosthetic joint infection (PJI) in patients undergoing cementless revision hip arthroplasty. The main questions it aims to answer are: - demonstrate that the hydrogel coating MectaShield does not interfere with primary stability; - evaluate clinical and functional outcomes, the rate of PJI and possible adverse events. Participants will undergo cementless revision hip arthroplasty; during surgery MectaShield hydrogel coating is applied on orthopaedic implants' surfaces (femoral stem and, if revised, acetabular cup) as a protective barrier for the prevention of bacterial adhesion. Surgery and follow-up are completed as per local standard practice. Stability will be assessed radiologically, while functional outcomes and PJI will be monitored by HOOS-PS, ASESPIS scores and according to the consensus document presented by European Society of Radiology (ESRa), the European Association of Nuclear Medicine (EANM), the European Bone and Joint Infection Society (EBJIS), and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID). Researchers will compare the results of the treatment group with those from a control group receiving cementless revision hip arthroplasty without the application of MectaShiled hydrogel coating.

NCT ID: NCT05678049 Not yet recruiting - Clinical trials for Osteoarthritis, Knee

Evaluation and Characterisation of Microplastics and Nanoplastics in Joint Synovial Liquid

Start date: January 15, 2023
Phase:
Study type: Observational

The research study aims to evaluate the synovial fluid to highlight the presence of possible micropolymers (micro/nanoplastics) in order to better understand the pathophysiology of joint degenerative processes. For patients with liquid under tension at the joint level, the symptomatology often requires evacuation by puncture under ultrasound guidance. The intervention will be performed only for patients for whom this therapeutic indication exists anyway by their physician. The investigators want to use this liquid for Microscopic and Spectrophotometric evaluation.

NCT ID: NCT05677542 Completed - Psoriatic Arthritis Clinical Trials

Secukinumab (Cosentyx®) Effectiveness in Axial Spondyloarthritis and Psoriatic Arthritis Patients Using Artificial Intelligence (SpAINET): Spanish Multicenter, Retrospective, Real World Evidence Study

Start date: June 2, 2021
Phase:
Study type: Observational

This was a multicenter, retrospective, and non-interventional study using secondary data captured in the Electronic Health Records (EHRs). The extraction of the data captured in the EHRs was performed with EHRead® by SAVANA, an innovating data-driven system based on Natural Language Processing (NLP) and big data analytics. Data was extracted and analyzed at Index Date, Follow Up, or as specified for each variable.

NCT ID: NCT05671627 Recruiting - Clinical trials for Rheumatoid Arthritis

Cortisol Circadian Rhythm in Patients With RA

CortRyRA
Start date: February 2, 2022
Phase:
Study type: Observational

The European League Against Rheumatism (EULAR), acknowledging the critical issue of the complications, of long term treatment with glucocorticoids in the most recent update of the management guidelines for Rheumatoid arthritis, recommends tapering (on sustained clinical remission) of oral glucocorticoids treatment at the earliest feasible time point of therapeutic course and to the lowest daily dose, preferably <7.5mg/day (prednisone equivalent), until the final target of withdrawal is succeeded. In clinical practice, these guidelines are often difficult to follow due to the high risk of disease flares after tapering or stopping glucocorticoids administration. This inability of tapering oral glucocorticoids below 7.5mg/day of prednisone or an equivalent synthetic glucocorticoid is included in the recent definition of difficult-to-treat Rheumatoid arthritis. SΕΜΙRΑ (Steroid EliMination In Rheumatoid Arthritis) study, a double-blind, multicentre, randomised controlled trial, compared oral glucocorticoids tapering with the continuation of low dose oral glucocorticoids. The population study consisted of 259 RA patients with low disease activity on treatment with 5mg per day prednisone and tocilizumab, an anti-interleukin (IL)-6 receptor antibody. The study demonstrated that the continued-prednisone regimen provided better maintenance of disease remission than did the tapered-prednisone regimen for the study period of 24 weeks with no symptoms suggestive of AI. However, the study protocol did not include biochemical assessment of adrenocortical function. Experimental and clinical data have suggested that inadequate production of endogenous cortisol relative to enhanced clinical needs associated with the systemic inflammatory response, coined as the 'disproportion principle', may operate in Rheumatoid arthritis. Although the underlying molecular mechanisms remain unknown, both chronic overexpression of proinflammatory cytokines and chronic stress may contribute in the hyporesponsiveness of the hypothalamic-pituitary-adrenal axis and the target tissue glucocorticoid resistance that have been described, but not systematically studied. Thus, a precise longitudinal assessment of endogenous cortisol production may be needed for optimal management of patients with Rheumatoid arthritis. Based on the above, the investigators seek to investigate the hypothesis that an impaired functional reserve of adrenal cortex, due to chronic over-expression of pro-inflammatory cytokines and/or chronic stress may contribute to the development of Rheumatoid arthritis and/or associate with difficult-to treat RA. If this is the case, then a disturbed cortisol circadian rhythm reflecting this impairment may serve as a predictor of difficult-to-treat RA during the first diagnosis. In order to address this issue, the investigators designed a prospective cohort study including adult patients with Rheumatoid arthritis who require drug treatment for the first time or escalation of existing treatment due to active disease. Patients will be treated as per clinician's judgement with any kind or combination of DMARDs with or without corticosteroids (corticosteroid regimens when started will not exceed 15 mg/day, and will be given for at least 3 months), following EULAR recommendations for RA treatment. Patients will be monitored at baseline, 3 months, 6 months and 12 months, assessing disease response to treatment, the need for continuing glucocorticoid treatment, inflammatory indexes, and diurnal salivary cortisol levels. Patients' classification will be based on EULAR response to treatment criteria for RA and cortisol circadian rhythm will be comparatively assessed (at baseline and at 3/6/12 months) between groups based on treatment response (EULAR guidelines).

NCT ID: NCT05671497 Recruiting - Clinical trials for Rheumatoid Arthritis

The Effect of Cilostazol on Rheumatoid Arthritis Patients

Start date: November 1, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of this study is to evaluate the effect of cilostazol on Rheumatoid Arthritis patients. It aims to answer the questions of : 1. Will Cilostazol improve the disease severity and quality of life in Rheumatoid arthritis patients? 2. Will Cilostazol decrease the oxidative stress, inflammation and endothelial dysfunction in Rheumatoid arthritis patients? Participants will be randomized into two arms either treatment or control the treatment group will be asked to take Cilostazol 100 mg twice daily in addition to the usual DMARD (Methotrexate , Sulfasalazine , Hydroxychloroquine or Leflunomide), while the control group will be taking the usual DMARDs only. Patients in both arms will be followed-up every 2 weeks through out the 6-month duration of the study.

NCT ID: NCT05669833 Recruiting - Psoriatic Arthritis Clinical Trials

Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients

EVOLUTION
Start date: July 14, 2023
Phase: Phase 3
Study type: Interventional

The trial is a double-blinded randomized study that will examine whether switching to a selective IL23 inhibitor (guselkumab) is more effective than switching to a second TNFi (golimumab) among patients with PsA who have an inadequate response to a TNFi.

NCT ID: NCT05666167 Recruiting - Arthritis Clinical Trials

Expanding Exercise Programming for Veterans Through Telehealth

Start date: April 1, 2023
Phase: N/A
Study type: Interventional

The goal of this study is to evaluate the acceptability and feasibility of a group telehealth exercise program for Veterans with lower extremity osteoarthritis (OA). Methods: This is a randomized pilot trial where Veterans (n=50) receive a group telehealth exercise program (3 months), followed by an exercise maintenance phase (6 months) that includes either text messaging alone or text messaging plus group telehealth exercise booster sessions. The primary outcomes for this study are feasibility and acceptability of the intervention. Feasibility will be assessed through number and source of referrals, recruitment, and retention. Acceptability will be assessed through surveys and interviews for participants and providers addressing reasons for participation, satisfaction, perceived appropriateness, and overall experience containing Likert scales and both yes/no and open-ended questions. Exploratory outcomes, assessed at multiple time points during the course of the study, will measure changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and changes in performance measure and physical activity assessed remotely through individual telehealth sessions. Data will be collected at baseline, 3-, 6-, and 9-month follow-up.

NCT ID: NCT05666115 Completed - Arthritis Clinical Trials

Efficacy of Modification of Lifestyle in the Treatment of Ankylosing Spondylitis: a Pilot Study

EMLAS
Start date: January 2, 2023
Phase: N/A
Study type: Interventional

Axial spondyloarthritis (axSpA) is a chronic inflammatory immune disorder with a global prevalence that ranges from 20 to 160 cases per 10000 individuals. axSpA has two forms of clinical presentation (radiographic and non-radiographic) based on the presence or absence of radiographic sacroiliitis. This condition mostly affects the vertebral spine, and is characterized by joint pain and stiffness, fatigue, and restricted function, which leads to a substantial physical, psychological, and socioeconomic burden. The clinical management of axSpA needs to combine pharmacological and non-pharmacological approaches to reduce inflammation and improve health-related quality of life. The aim of the study will be to determine if a 12-week probiotic supplementation will be more effective than an online-delivered strength training program at improving functional capacity in adults with non-radiographic axSpA. As a secondary aim, we will compare the impact of both interventions on disease activity, spinal mobility, quality of life and biochemical measures. This will be the first randomized controlled trial where probiotics are compared with an active intervention.

NCT ID: NCT05665985 Completed - Clinical trials for Rheumatoid Arthritis

Effect Of Moringa Leaf Extract On Disease Activity In Rheumatoid Arthritis Patients

Start date: May 1, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Intervention therapy study of moringa oliefera extract on the degree of activity of rheumatoid arthritis patients. The research subjects were patients with rheumatoid arthritis-intervention with moringa oliefera for 30 days.

NCT ID: NCT05664724 Not yet recruiting - Clinical trials for Osteoarthritis, Knee

Simultaneous Physiotherapy and Orthopedic Surgeon Interdisciplinary Care (SPOSIC)

SPOSIC
Start date: February 2023
Phase: N/A
Study type: Interventional

This study will test a protocol to implement simultaneous physiotherapy and orthopedic surgeon interdisciplinary care for patients undergoing knee replacement surgery. These interdisciplinary sessions will help tailor personalized goals, involving the patient as a key member of the team.