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NCT ID: NCT04517669 Recruiting - Psoriatic Arthritis Clinical Trials

Effectiveness of Treatment With Tofacitinib in Patients With Psoriatic Arthritis in Routine Clinical Practice

Start date: May 17, 2021
Phase:
Study type: Observational [Patient Registry]

This is a Multinational Study of Tofacitinib in Patients Treated for Psoriatic Arthritis in order to evaluate the effectiveness of treatment with tofacitinib on disease activity, remission, and Quality of Life, in a real-world setting over a 12-month observation period

NCT ID: NCT04512638 Recruiting - Clinical trials for Medication Related Osteonecrosis of the Jaw

Best Treatment Choice for Osteonecrosis of the Jaw

BETCON
Start date: January 1, 2021
Phase: Phase 4
Study type: Interventional

BETCON is a pragmatic randomized controlled open-label multi-center study in patients with newly diagnosed stage I-II MRONJ designed to answer the question whether minimally invasive management with LPRF membranes or primary surgical treatment is better than the standard of care of conservative therapy alone. The primary end-point is the time to mucosal healing. Secondary end-points consist of supporting measures of efficacy, patient reported symptoms, quality of life, well-being, and functioning.

NCT ID: NCT04512209 Recruiting - Ovarian Cancer Clinical Trials

Characterization of Biophysical Stromal Properties in Human Cancer: Towards Personalized Computational Oncology

DCE-MRI
Start date: October 11, 2019
Phase: N/A
Study type: Interventional

Drug delivery in solid tumors, whether administered systemically or locoregionally, is hindered by an elevated interstitial fluid pressure (IFP). Stromal targeting therapies are in active development, aiming to enhance drug transport after systemic or locoregional delivery. To date, no clinical methods are available to quantify tumor biophysical properties (including IFP). The investigators aim to use a combination of dynamic contrast enhanced MRI and computational fluid modeling (CFD) to measure stromal IFP in patients with pancreatic cancer and in patients with ovarian or colonic peritoneal carcinomatosis (PC). Computational data will be correlated with therapy response, platinum drug penetration, and invasively measured biophysical parameters after intravenous (pancreas) or intraperitoneal (ovarian/colonic PC) administration of a platinum compound. This would be the first in depth clinical study addressing this important topic, and could pave the way to developing personalized computational based treatment approaches aimed at targeting the biophysical environment of the tumor stroma in order to enhance cancer drug delivery.

NCT ID: NCT04511364 Recruiting - Osteoporosis Clinical Trials

EXTENSION - Long-term Follow-up Study of Patients Treated With AGN1 LOEP

Start date: August 28, 2020
Phase: N/A
Study type: Interventional

The study is designed as a multi-center study within Europe in up to 60 patients treated with the AGN1 LOEP Kit in CONFIRM. This will be a non-randomized and non-blinded study. The study will collect long-term follow-up data on the safety and clinical performance of AGN1 LOEP. To qualify, subjects must have previously consented, enrolled, and been treated with the AGN1 LOEP kit in CONFIRM (AgNovos Study PST-EU-101.1). Follow-up evaluations will be conducted at 24, 36, 48 and 60 months from the date the subject originally received the AGN1 LOEP treatment. Subjects will receive DXA and X-ray imaging at the 24- and 60-month follow-up visits. The 36- and 48-month follow-up evaluations will be conducted by phone. All timepoints will include general health and medical record review.

NCT ID: NCT04511104 Recruiting - Burns Clinical Trials

Effects of Exercise During the Acute Phase of Burns

Start date: May 4, 2020
Phase: Phase 2
Study type: Interventional

BACKGROUND: Postburn changes in whole-body, glucose and protein metabolism are at their peak during the acute phase of severe burns. The resulting metabolic derangements lead to substantial muscle wasting, insulin resistance, which ultimately hampers full recovery and reintegration into society. PURPOSE: This quasi-experimental trial was initiated to investigate the effects of exercise-based rehabilitation on muscle wasting, insulin resistance, and quality of life during the acute phase of severe adult burns. METHODS: Moderate to severely burned adults (10-80%TBSA) will be recruited from two Belgian burn centres. Subjects allocated to the intervention group will undergo an up to 8-week-long exercise program in addition to standard care rehabilitation. As part of the exercise program, participants will carry out progressive resistance and aerobic training, initiated as soon as medical safety and patient cooperation allow. Exercise type and dosage will be chosen according to patient status in terms of grafts, mobility, and strength. The control group will receive standard care rehabilitation only, including passive, assisted, active range of motion exercise, functional exercise, and scar treatment. The effect on muscle wasting will be determined by B-mode ultrasound-derived measures of quadriceps muscle layer thickness (QMLT) and rectus femoris cross sectional area, as well as peak force measurements by handheld dynamometry. Insulin resistance will be derived from the HOMA-2 index based on fasting plasma glucose and insulin. Quality of life will be determined by the EQ-5D-5L and Burn Specific Health Scale-Brief (BSHS-B) questionnaires. The results of this clinical research will provide insight into the effects of exercise on both a fundamental and clinical spectrum.

NCT ID: NCT04509700 Recruiting - B-Cell Malignancies Clinical Trials

Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)

Start date: August 3, 2020
Phase: Phase 2
Study type: Interventional

This is a Phase 2, multicenter, open-label study to provide continued supply of parsaclisib as monotherapy or in combination therapy with itacitinib, ruxolitinib, or ibrutinib to participants from Incyte-sponsored studies of parsaclisib.

NCT ID: NCT04507854 Recruiting - Surgery Clinical Trials

Return to Performance Criteria Following Shoulder Instability Surgery in the Athlete.

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

The purpose of this study is to determine whether certain criteria for returning to the field can be predictive of a return of the athlete to a level of performance similar to that of before his shoulder injury. In this context, these different criteria will be tested at 6 months in post-surgery while performance monitoring will be carried out at 12, 18 and 24 months.

NCT ID: NCT04507451 Recruiting - Critical Illness Clinical Trials

Respiratory Muscle Training in ICU Patients

Start date: October 1, 2020
Phase: N/A
Study type: Interventional

Respiratory muscle weakness is common after mechanical ventilation and occurs early. This can limit functional recovery. Respiratory muscle training is often neglected in clinical practice. Some data indicates that inspiratory muscle training increases inspiratory muscle strength and quality of life. The aim of the study is to assess the impact of combined inspiratory and expiratory muscle training on inspiratory muscle strength. The second aim is to assess the impact of this training program on expiratory muscle strength.

NCT ID: NCT04505982 Recruiting - Clinical trials for Rheumatoid Polyarthritis

Anti IL6R Reduce Complement Serum Level in Rheumatoid Arthritis Patients: Facts and Implications

Start date: July 14, 2020
Phase:
Study type: Observational

Interleukin 6 is identified as a cytokine with pro and anti-inflammatory effects, depending on the context to which it is exposed, exerting a role in the expansion and activation of T lymphocytes, in the survival, expansion and the maturation of B lymphocytes and plasmablasts as well as in the regulation of the acute phase response. The IL-6 receptor complex is a dimer in which each monomer is composed of an 80 kD subunit, IL-6R or CD126, expressed in hepatocytes, leukocytes and in megakaryocytes, which binds IL- 6 and a 130 kD subunit, gp130 or CD130, which is expressed ubiquitously. Its effects are mediated mainly by the way of tyrosine kinases of the Jaks family, and transcription factors of the STATs family. The complement system is made up of a set of plasma proteins, cascading through three activation pathways (classical, alternate and lectin pathway). This system is considered part of innate immunity. It is also part of the acute phase response.The complement has several functions: cell lysis by formation of the membrane attack complex; opsonization and activation of phagocytosis of foreign particles, elimination of circulating immune complexes, and regulation of the adaptive immunity response and inflammation via anaphylatoxins. After reviewing the literature, the link between IL6 and the complement system can be summarized as an induction of factor C3 and factor B, but also probably CD55 (DAF or Decay acceleration factor) and CD59 (MAC-IP or MAC-Inhibitory Protein) by interleukin-6. The effects of IL-6 on the lectin pathway, on the other hand, seem contradictory: inhibition or induction of the synthesis of MASP1 / 3 and 2 depending on the experimental model. It has become common knowledge that anti-IL6 receptor monoclonal antibodies, used in the treatment of patients with rheumatoid arthritis and other inflammatory conditions, reduce the serum levels of acute phase proteins and in particular the levels of CRP. But what about other acute phase proteins and in particular the complement ? A recent study showed that the serum levels of the complement components C3 and C4 were also reduced after the use of tocilizumab and this as early as 4 weeks after the first administration. To the investigator's knowledge, this is the only study reporting a decrease in complement during treatment with anti-IL6R. This study would allow the evaluation of complement parameters in the population of patients under treatment with antiIL6R (tocilizumab or sarilumab) within the CHU Brugmann Hospital in order to - confirm or not this observation - look for a possible secondary clinical consequence - compare this decrease with the activity of the disease in order to see if it could be a marker of effectiveness - put this decrease in parallel with the side effects / tolerance of the treatment in order to see if it could be a marker of toxicity / safety This study will also investigate the subpopulations of B lymphocytes (memory B, transitional B, and plasmablasts) in order to assess whether the evolution of one of these lines would be predictive of a therapeutic response. Secondly, this study would eventually allow - to improve the understanding of the mechanisms of action of the treatment on inflammatory markers by evaluating the activity of the residual complement - to raise the need to find new parameters for monitoring inflammatory activity in these patients, since CRP assays are not very helpful.

NCT ID: NCT04503486 Recruiting - Quality of Life Clinical Trials

Relationship Between Muscle Strength and Quality of Life in ICU Survivors

Start date: August 1, 2020
Phase:
Study type: Observational

The aim is to study the impact of muscle strength measured in ICU and after ICU discharge on health-related quality of life measured after hospital discharge.