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Collagen Diseases clinical trials

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NCT ID: NCT02508428 Completed - Osteoarthritis Clinical Trials

Marathon and Enduron Polyethylene at Long-Term Follow-up

Start date: January 6, 1999
Phase: N/A
Study type: Interventional

The purpose of the study is to determine whether crosslinked Marathon and standard Enduron polyethylene liners show differences in survivorship due to wear-related revisions at minimum 14-year follow-up and every 5 years after.

NCT ID: NCT02484053 Completed - Oncologic Disorders Clinical Trials

Rapid Infusion Rituximab, Hematologic, Oncologic, and Rheumatologic Disorders

Start date: June 2015
Phase: Early Phase 1
Study type: Interventional

Rituximab is frequently used in adult and pediatric cancers, blood disorders, lymphoma (a cancerous growth made up of lymphoid tissue), graft-versus-host-disease (complication that can occur after a stem cell or bone marrow transplant), diseases of the immune system (the cells and substances that protect the body from infection) and rheumatologic conditions. Rituximab works by decreasing or temporarily eliminating a specific type of white blood cell, the B-lymphocyte. Overall, rituximab is generally well tolerated. The likelihood of an infusion-related reaction, or symptoms such as fever, chills, hives, low blood pressure or swelling, is very low, but highest during a patient's first infusion of rituximab and decreases with each additional dose. Adults commonly receive rituximab at a faster rate if they have done well with the first infusion, this study will help determine if the same approach is well tolerated in children. In this study, the investigators are testing a new method of administering rituximab which may reduce the time it takes to receive the medication. The initial ordered amount of rituximab will not change from the current standard of care (meaning what is usually done by doctors, and would likely be done if you were not on this study). The period of time over which rituximab is given is what is being studied.

NCT ID: NCT02436096 Completed - Fibromyalgia Clinical Trials

A Study to Evaluate eFFIcacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With fibRoMyalgia

AFFIRM
Start date: April 2015
Phase: Phase 3
Study type: Interventional

The use of low-dose CBP dosed nightly at bedtime for FM was supported by the results of Tonix' TNX-CY-F202 Phase 2b study (also referred to as the BESTFIT Study). The TNX-CY-F202 study provided strong evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects upon pain, sleep and other FM symptomatology. The present trial is designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime over 12 weeks to treat fibromyalgia.

NCT ID: NCT02430402 Completed - Rheumatic Diseases Clinical Trials

Rehabilitation of Young Patients With Rheumatic Diseases in a Warm Climate

Start date: May 2015
Phase: N/A
Study type: Interventional

Young patients with rheumatic diseases have challenges different from older patients due to their life situation. It has been reported that they do not have the same benefit from age non-specific rehabilitation in warm climate. This trial will test the effect of a specially adapted version of a rehabilitation program delivered in Spain (warm climate) for Norwegian young adults aged 20-35 years.

NCT ID: NCT02402894 Completed - Clinical trials for Arthritis, Rheumatoid

Follow-up of Person-centered Care of Young Adults With Rheumatic Disease

Start date: February 2015
Phase:
Study type: Observational

The purpose of the study is to study how a person-centered structured team caretaking of young adults (16-23 years) with newly diagnosed rheumatoid arthritis (RA), spondartrit (SpA) and psoriasartrit (PsA) in routine clinical care affect and predict the patient's health and ability to manage their everyday lives. Also included in the project is a long-term follow-up (up to 50 years) where the investigators want to investigate factors predicting good general health, low disease activity, good physical function, and comorbidity.

NCT ID: NCT02291471 Completed - Rheumatic Diseases Clinical Trials

Tolerance and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers

Start date: October 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study to assess the MTD and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers.

NCT ID: NCT02269254 Completed - Clinical trials for Musculoskeletal Diseases

Persona Versus NexGen

Start date: September 2014
Phase: N/A
Study type: Interventional

The NexGen TKR (Zimmer, Warsaw, Indiana, USA) is a proven TKR design that has reported excellent medium and long-term results in clinical studies and in implant registries all around the world. As a follow-up of the NexGen TKR, an improved design has recently been introduced by Zimmer: The Persona TKR (Zimmer, Warsaw, Indiana, USA) has been used successfully in about 20.000 patients, but results from independent clinical studies have not been reported yet. The objective of this study is to accurately assess and compare migration, kinematics, prosthesis placement and patient reported outcomes of two TKR prostheses: the fixed bearing, cemented NexGen LPS, a proven design with an excellent clinical track record, and the fixed bearing, cemented Persona PS, a new design without clinical data (both designs by Zimmer, Warsaw, Indiana, USA). The primary objective is to assess and compare migration of the two TKR prostheses (Femoral and Tibial component). The secondary objective is to assess and compare clinical data, kinematics, prosthesis placement and patient reported outcome measures. This study is designed as a single-blind randomized trial between the Persona PS total knee prosthesis and the well-established NexGen total knee prosthesis. Different sample sizes are used for the different parts of this study: - 30 Patients with NexGen LPS prosthesis and 30 patients with Persona PS prosthesis for RSA - 15 Patients with NexGen LPS prosthesis and 15 patients with Persona PS prosthesis for Fluo The study population will consist of patients with symptomatic osteoarthritis of the knee scheduled for TKR surgery at the Department of Orthopaedics, Leiden University Medical Center. Annually 40 TKA procedures are performed in our department, of which about 70% is Osteo Arthritis (OA) and 30% Reumatoid Arthritis (RA). We anticipate that inclusion can be accomplished within a 2 year period. Main study parameters/endpoints are: - Migration, measured by means of RSA. - Prosthesis placement and bone resection measured by means of CT and caliper measurements of the resected bone parts. - In vivo kinematics by means of fluoroscopy. - Patient Reported Outcome Measures by means of questionaires.

NCT ID: NCT02265029 Completed - Fibromyalgia Clinical Trials

Evaluation of Spa Therapy in the Treatment of Fibromyalgia

THERMALGI
Start date: September 2014
Phase: N/A
Study type: Interventional

Fibromyalgia is a common health problem that causes widespread pain and tenderness (sensitive to touch). The pain and tenderness tend to come and go, and move about the body. There is no cure for fibromyalgia. Complementary and alternative therapy such as acupuncture, chiropractic and massage therapy, can be useful to manage fibromyalgia symptoms. Many of these treatments have not been well tested in patients with fibromyalgia. Fibromyalgia affect 3 to 4% of the general population and 14 % of patients with rheumatologic disease. Fibromyalgia is most common in women 90 % in many studies. It most often starts in middle adulthood. A chronic evolution occured for Fibromyalgic patients with a major alteration of quality of life. Thermalgi is a randomized, multicentre, open label trial wich aims to evaluate the effects of spa therapy in rheumatologia on evolution of disability in daily life of patients with fibromyalgia.

NCT ID: NCT02256098 Completed - Clinical trials for Musculoskeletal Diseases

RSA RCT: ATTUNE™ TKA Versus PFC Sigma TKA

APKnee
Start date: September 2014
Phase: N/A
Study type: Interventional

The PFC Sigma Knee by DePuy Synthes is an excellent knee replacement with an excellent clinical track record, good survival rates (98% 10 years survival in patients aged < 55 years)(Keenan et al., 2012) and minimal early migration as measured with RSA (0.5mm MTPM at two years follow-up)(von et al., 2009). The ATTUNE™ Knee by DePuy Synthes is an advancement in knee replacement options. It is designed to provide better range of motion and address the unstable feeling some patients experience during everyday activities, such as stair descent and bending. To date (March 2013), more than 3,500 patients have received an ATTUNE Knee as part of a limited launch and positive feedback was received regarding patient recovery, stability and motion. The objective of this study is to accurately assess and compare migration, clinical and radiological outcome and patient reported outcomes of two TKR prostheses: the Cemented ATTUNE™ Fixed Bearing Cruciate Retaining Knee System and the Cemented PFC Sigma Fixed Bearing Cruciate Retaining Knee System, both by DePuy Synthes, Warsaw, Indiana, USA. The primary objective of this study is to compare the magnitude and pattern of migration of the prostheses (Femoral and Tibial component). The secondary objective of this study is to compare clinical and radiological outcome of the prostheses and PROMS. The tertiary objective of this study is to compare clinical and radiological outcome and PROMS of the prostheses with migration data. This study is designed as a single-blind, randomized trial between the ATTUNE™ Knee System and PFC Sigma Knee System. 32 patients with the ATTUNE™ Knee System and 32 patients with PFC Sigma Knee System will be included in this study. The study population will consist of patients with symptomatic osteoarthritis of the knee scheduled for TKR surgery at the Department of Orthopaedics, Medisch Centrum Haaglanden, The Hague, The Netherlands. Annually 300 TKA procedures are performed in this department, of which about 90% is Osteo Arthritis (OA) and 10% Rheumatoid Arthritis (RA) and other indications. We anticipate that inclusion can be accomplished within a 1 year period and that the total study duration is 3 years. Main study parameters/endpoints are: - Migration of the prosthesis with respect to the host bone measured by means of roentgen stereophotogrammetric analysis (RSA). - Patient Reported Outcome Measures by means of questionnaires.

NCT ID: NCT02164214 Completed - Clinical trials for Rheumatoid Arthritis

Does Etanercept Influence Tweak Modulation of Inflammation During Inflammatory Rheumatisms (Psoriatic Arthritis and Rheumatoid Arthritis)?

Start date: September 2011
Phase: Phase 3
Study type: Interventional

TWEAK (TNF weakly inducer of apoptosis) is a type II-transmembrane protein, member of the TNF ligand superfamily that can be cleaved to function as a soluble cytokine. Depending on target cell type, TWEAK triggers multiple cellular responses ranging from modulation of inflammation to cell death when it binds to its main receptor, Fn 14. Our team has been the first to describe pro-inflammatory effects of TWEAK during central nervous system inflammation. Various data support the possibility that TWEAK produced by synovial macrophages may contribute to chronic synovitis in animal models and in humans. In psoriatic arthritis (PsoA), anti-TNF therapy has been successful concording with the key role of TNF in the pathogenesis of this disease and the generation by psoriatic patients of neutralizing anti-TNF autoantibodies referred as "beneficial autoimmunity to pro-inflammatory mediators". In 2010, Van Kuijk et al. have described a high expression of TWEAK in the inflammatory synovial of PsoA and rheumatoid arthritis (RA) patients before and after anti-TNF therapy. The role of TNF-alpha in the regulation of TWEAK expression remains unclear.