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Rheumatic Diseases clinical trials

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NCT ID: NCT04976972 Not yet recruiting - Osteoarthritis Clinical Trials

A Comparison of Patients Receiving a Total Knee Replacement With Robotic Assistance or With Conventional Instrumentation

Start date: September 30, 2021
Phase: N/A
Study type: Interventional

A total knee replacement is the removal of parts of the knee joint, that have become damaged due to osteoarthritis, and replacing these with artificial implants. The placement of these artificial implants and how they are aligned with each other is important because they can impact overall knee function and the long-term survival of the implant. It is reported that up to 34% of all patients following total knee replacement (TKR) have poor outcomes functionally. There have been significant developments in knee replacement surgery over recent years. In particular, the introduction of robotic surgical systems, such as the NAVIO and CORI systems (Smith+Nephew Plc). The NAVIO and CORI Surgical Systems are hand-held devices which can support the surgeon with the knee replacement procedure, the systems are image-free and do not require the patient to undergo any scans (such as CT scans). During the surgery, the surgeon uses the NAVIO/CORI hand-held device to map specific landmarks within the knee joint and determines the desired alignment using associated computer software. The tools to remove the bone and place the implants are controlled by the surgeon with the guidance of the NAVIO/CORI software. Comparisons of robotic systems to conventional instruments have demonstrated that robotic platforms produce fewer positioning errors in total knee replacement. This can result in more precise knee alignment and better outcomes following surgery. With both the NAVIO and CORI Surgical Systems there is a reduction in radiation exposure due to them being image-free. At present, there is some evidence available for the long-term outcomes of total knee replacement implanted using robotic assistance (i.e. 2-10 years) however this study is designed to look at the early outcomes following TKR. There is no literature to date to show that robotic-assisted TKR is superior to conventional methods, within the early post-operative period (up to 12 months). This study is designed to show that the NAVIO/CORI surgical systems are better than conventional methods for TKR. The hypothesis is that they will be cost-effective, will reduce the time a patient spends in hospital following their surgery, will improve patient satisfaction during the early recovery period and will improve the patient's early post-operative mobility and function.

NCT ID: NCT04970550 Recruiting - Clinical trials for Rheumatoid Arthritis

Vaccination Against SARS-Cov2 (COVID-19) in Chronic Inflammatory Rheumatism and Factors Determining Its Decision.

VACCI-RIC
Start date: June 1, 2021
Phase:
Study type: Observational

Rheumatoid arthritis and spondyloarthritis (ankylosing spondylitis and psoriatic arthritis mainly) are chronic inflammatory rheumatism (RIC), frequently onset in young adults. The prevalence is respectively 0.3 to 0.8% and 0.4%. or about 600,000 people. The "basic" treatments (DMARDs), essential to control the progression of the disease, are classified into csDMARDs (chemical), the first of which is methotrexate, or bDMARDs (biological). These treatments are immunomodulators and there is an increased risk of severe infection under these therapies. Several vaccinations are therefore recommended by learned societies in patients receiving these treatments, in order to prevent certain infectious risks.In the current pandemic context, the vaccination of these patients against SARS-Cov2 is a major issue in their management and is recommended by the French society of rheumatology. However, many patients express doubts about this vaccination or refuse it. The factors associated with the vaccination will are not known. Better identifying them would make it possible to adapt the information to be given to our patients to promote their adherence.

NCT ID: NCT04948099 Recruiting - Clinical trials for Dendritic Cell -Mediated Rheumatic Diseases

A Study of Single Ascending Doses of VIB1116 in Rheumatic Diseases

Start date: June 2021
Phase: Phase 1
Study type: Interventional

A first-in-human study to evaluate the safety and tolerability of escalating, single subcutaneous or IV doses of VIB1116 in adult participants with rheumatic diseases.

NCT ID: NCT04908202 Not yet recruiting - Psoriatic Arthritis Clinical Trials

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs

Start date: July 7, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of deucravacitinib versus placebo in participants with active psoriatic arthritis who are naïve to biologic disease-modifying anti-rheumatic drugs.

NCT ID: NCT04902807 Not yet recruiting - Clinical trials for Systemic Lupus Erythematosus

Conception of a Diagnosis, Prognosis and Therapeutic Decision Tool for Patients With Autoimmunity and Inflammation

ATRACTion
Start date: June 2021
Phase:
Study type: Observational

The main objective of this study is to generate diagnosis and therapeutic-decision tools through the identification of molecular causes of PIDs with autoimmunity/inflammation and the variability in disease outcome at the transcriptional level using a combination of omics signatures (transcriptomics, epigenomics, proteomics, metagenomics, metabolomics and lipidomics).

NCT ID: NCT04890483 Recruiting - Autoimmune Diseases Clinical Trials

tDCS in Post-Acute COVID-19 Patients With SARDs

Start date: May 17, 2021
Phase: N/A
Study type: Interventional

Some patients develop "Post-acute COVID-19 syndrome," in which they experience persistent symptoms after recovering from the acute phase of COVID-19 infection. This syndrome may be more significant in patients with systemic autoimmune rheumatic diseases (SARDs) who have been suffering from several symptoms associated to SARDs, such as myalgia, fatigue, and general pains. The transcranial direct current stimulation (tDCS) technique has been frequent, for example, to relieve fatigue and general pains in general population. However, to date, there are no studies evaluating this technique in ARD patients with post-acute COVID-19; therefore, the main objective of the opened study is to evaluate the safety and efficacy of the application of acute tDCS in ARD patients with post-acute COVID-19.

NCT ID: NCT04879745 Recruiting - Contraception Clinical Trials

MyVoice:Rheum Decision Aid for Women With Rheumatic Diseases

Start date: July 1, 2021
Phase: N/A
Study type: Interventional

This is a pilot trial to assess feasibility and acceptability of MyVoice vs. a patient pamphlet among female patients ages 18-44 (n=50) who receive rheumatology care. • Hypothesis: MyVoice will be feasible and acceptable to patients who receive rheumatology care.

NCT ID: NCT04868591 Recruiting - Clinical trials for Musculoskeletal Pain Disorder

Single Session Compared to Multiple Sessions of Education and Exercise for Older Adults With Spinal Pain in an Advanced Practice Physiotherapy Model of Care

Start date: May 15, 2021
Phase: N/A
Study type: Interventional

Objectives: To assess the effectiveness and cost-effectiveness of a single session compared to multiple sessions of education and exercise for older adults with spinal pain treated conservatively in an advanced practice physiotherapy (APP) model of care. Methods and Analysis: In this pragmatic randomized controlled trial, 136 older adults (≥ 65 years old) with neck or back pain initially referred for a consultation in neurosurgery, but treated conservatively, will be recruited through the APP neurosurgery CareAxis program in the Montreal region (Quebec, Canada). In the CareAxis program, older patients with spinal pain are triaged by an advance practice physiotherapist and are offered conservative care and only potential surgical candidates are referred to a neurosurgeon. Participants will be randomized into one of two arms: 1- a single session or 2- multiple sessions (6 sessions over 12 weeks) of education and exercise with the advance practice physiotherapist. The primary outcome measure will be the Brief Pain Inventory (pain severity and interference subscales). Secondary measures will include self-reported disability (the Neck Disability Index or Oswestry Disability Index), The Pain Catastrophizing Scale, satisfaction with care (VSQ-9 and MedRisk questionnaires), and health-related quality of life (EQ-5D-5L). Participants healthcare resources use, and related costs will be measured. Outcomes will be collected at baseline and at 6, 12 and 26 weeks after enrollment. Intention-to-treat analyses will be performed, and repeated mixed-model ANOVA will assess differences between treatment arms. Cost-utility analyses will be conducted from the perspective of the health care system. Ethics and dissemination: Ethics approval has been obtained from the Comité d'éthique de la recherche du CIUSS de l'Est-de-l'Île-de-Montréal (FWA00001935 and IRB00002087). Results of this study will be presented to different stakeholders, published in peer-reviewed journals and presented at international conferences.

NCT ID: NCT04848493 Recruiting - COVID-19 Clinical Trials

National Project on Vaccines, COVID-19 and Frail Patients

VAX4FRAIL
Start date: April 19, 2021
Phase:
Study type: Observational

This is a multicentre observational study with the aim of evaluating the antibody and cellular response after vaccination for SARS-CoV-2 with Pfizer-BioNTech or Moderna vaccines in frail subjects with impaired immuno-competence, due to their underlying diseases or ongoing therapies.

NCT ID: NCT04845997 Not yet recruiting - Rheumatic Diseases Clinical Trials

COVID-19 Vaccination in Patients With Rheumatic Diseases

SAR-CoVAC
Start date: April 20, 2021
Phase:
Study type: Observational [Patient Registry]

The Argentine Society of Rheumatology (SAR) set out to develop a national register of patients with rheumatic diseases who have received a SARS-CoV-2 vaccine in order to assess their efficacy and safety in this population.